"producttype","eventid","status","recallingfirm","city","state","country","voluntarymandated","initialfirmnotificationofconsign","distributionpattern","recallnumber","classification","productdescription","codeinfo","codeinfocontinued","productquantity","reasonforrecall","recallinitiationdate","recallinitiationdatestr","reportdate","reportdatestr"
"Biologics",32603,"Ongoing","One Lambda Inc","Canoga Park","CA","US","Voluntary: Firm Initiated","Letter","US states nationwide. International: Canada, U.A.E, Saudi Arabia, Cyprus, UK, France, Germany, Greece, Israel, Italy, S.Africa, Jordan, Kuwait, Lebanon, Poland, Serbia, Croatia, Seria, Montenegro, Austria, Netherlands, Russia, Finland, Spain & Portugal, Turkey, Russia, Finland, Brazil, Argentina, Australia, Qatar, Bangladesh, Korea, China, Chile, Bolivia, Paraguay, Costa Rica, Ecuador, Guatemala, India, Japan, Mexico, Malaysia, New Zealand, Peru Philippines, Pakistan.","B-1422-13","Class III","Micro SSP DNA Typing Trays Micro SSP Allele Specific HLA Class I Typing Tray - A*11 Article Number: SSP_DNAT_PI Rev 18 510(K) Number : BK960062 ","Catalog Identification: SSP1-11 (Lot Number: 002) and SSPR1-11 (Lot Number: 003). ",".","2","Micro SSP DNA Typing Trays of HLA Class I and Class II alleles, where null allele entries were not properly verified and may cause misassignment, were distributed. ",2/21/2013,"02/21/2013",5/15/2013,"05/15/2013"
"Biologics",32603,"Ongoing","One Lambda Inc","Canoga Park","CA","US","Voluntary: Firm Initiated","Letter","US states nationwide. International: Canada, U.A.E, Saudi Arabia, Cyprus, UK, France, Germany, Greece, Israel, Italy, S.Africa, Jordan, Kuwait, Lebanon, Poland, Serbia, Croatia, Seria, Montenegro, Austria, Netherlands, Russia, Finland, Spain & Portugal, Turkey, Russia, Finland, Brazil, Argentina, Australia, Qatar, Bangladesh, Korea, China, Chile, Bolivia, Paraguay, Costa Rica, Ecuador, Guatemala, India, Japan, Mexico, Malaysia, New Zealand, Peru Philippines, Pakistan.","B-1428-13","Class III","Micro SSP DNA Typing Trays Micro SSP Generic HLA Class II DNA Typing Tray - DRB/DQB1/DPB1 Article Number: SSP_DNAT_PI Rev 18 510(K) Number : BK960062 ","Catalog Identification: SSPDRQP1 Lot Number: 001 ",".","1","Micro SSP DNA Typing Trays of HLA Class I and Class II alleles, where null allele entries were not properly verified and may cause misassignment, were distributed. ",2/21/2013,"02/21/2013",5/15/2013,"05/15/2013"
"Biologics",32603,"Ongoing","One Lambda Inc","Canoga Park","CA","US","Voluntary: Firm Initiated","Letter","US states nationwide. International: Canada, U.A.E, Saudi Arabia, Cyprus, UK, France, Germany, Greece, Israel, Italy, S.Africa, Jordan, Kuwait, Lebanon, Poland, Serbia, Croatia, Seria, Montenegro, Austria, Netherlands, Russia, Finland, Spain & Portugal, Turkey, Russia, Finland, Brazil, Argentina, Australia, Qatar, Bangladesh, Korea, China, Chile, Bolivia, Paraguay, Costa Rica, Ecuador, Guatemala, India, Japan, Mexico, Malaysia, New Zealand, Peru Philippines, Pakistan.","B-1427-13","Class III","Micro SSP DNA Typing Trays Micro SSP HLA Class I and II ABDR DNA Typing Tray Article Number: SSP_DNAT_PI Rev 18 510(K) Number : BK960062 ","Catalog Identification: SSPABDR (Lot Number: 008 and 009) and SSPABDRX (Lot Number: 008 and 009) ",".","4","Micro SSP DNA Typing Trays of HLA Class I and Class II alleles, where null allele entries were not properly verified and may cause misassignment, were distributed. ",2/21/2013,"02/21/2013",5/15/2013,"05/15/2013"
"Biologics",32603,"Ongoing","One Lambda Inc","Canoga Park","CA","US","Voluntary: Firm Initiated","Letter","US states nationwide. International: Canada, U.A.E, Saudi Arabia, Cyprus, UK, France, Germany, Greece, Israel, Italy, S.Africa, Jordan, Kuwait, Lebanon, Poland, Serbia, Croatia, Seria, Montenegro, Austria, Netherlands, Russia, Finland, Spain & Portugal, Turkey, Russia, Finland, Brazil, Argentina, Australia, Qatar, Bangladesh, Korea, China, Chile, Bolivia, Paraguay, Costa Rica, Ecuador, Guatemala, India, Japan, Mexico, Malaysia, New Zealand, Peru Philippines, Pakistan.","B-1429-13","Class III","Micro SSP DNA Typing Trays Micro SSP Generic HLA Class I and II DNA Typing Tray - ABDRDQ Article Number: SSP_DNAT_PI Rev 18 510(K) Number : BK960062 ","Catalog Identification: SSPML02 Lot Number: 003 and 004 ",".","2","Micro SSP DNA Typing Trays of HLA Class I and Class II alleles, where null allele entries were not properly verified and may cause misassignment, were distributed. ",2/21/2013,"02/21/2013",5/15/2013,"05/15/2013"
"Biologics",32603,"Ongoing","One Lambda Inc","Canoga Park","CA","US","Voluntary: Firm Initiated","Letter","US states nationwide. International: Canada, U.A.E, Saudi Arabia, Cyprus, UK, France, Germany, Greece, Israel, Italy, S.Africa, Jordan, Kuwait, Lebanon, Poland, Serbia, Croatia, Seria, Montenegro, Austria, Netherlands, Russia, Finland, Spain & Portugal, Turkey, Russia, Finland, Brazil, Argentina, Australia, Qatar, Bangladesh, Korea, China, Chile, Bolivia, Paraguay, Costa Rica, Ecuador, Guatemala, India, Japan, Mexico, Malaysia, New Zealand, Peru Philippines, Pakistan.","B-1424-13","Class III","Micro SSP DNA Typing Trays Micro SSP High Resolution HLA Class II DNA Typing Tray Article Number: SSP_DNAT_PI Rev 18 510(K) Number : BK960062 ","Catalog Identification: SSP2H Lot Number: 04A and 005 ",".","2","Micro SSP DNA Typing Trays of HLA Class I and Class II alleles, where null allele entries were not properly verified and may cause misassignment, were distributed. ",2/21/2013,"02/21/2013",5/15/2013,"05/15/2013"
"Biologics",32603,"Ongoing","One Lambda Inc","Canoga Park","CA","US","Voluntary: Firm Initiated","Letter","US states nationwide. International: Canada, U.A.E, Saudi Arabia, Cyprus, UK, France, Germany, Greece, Israel, Italy, S.Africa, Jordan, Kuwait, Lebanon, Poland, Serbia, Croatia, Seria, Montenegro, Austria, Netherlands, Russia, Finland, Spain & Portugal, Turkey, Russia, Finland, Brazil, Argentina, Australia, Qatar, Bangladesh, Korea, China, Chile, Bolivia, Paraguay, Costa Rica, Ecuador, Guatemala, India, Japan, Mexico, Malaysia, New Zealand, Peru Philippines, Pakistan.","B-1423-13","Class III","Micro SSP DNA Typing Trays Micro SSP Allele Specific HLA Class I Typing Tray - A*26 Article Number: SSP_DNAT_PI Rev 18 510(K) Number : BK960062 ","Catalog Identification: SSP1-26 Lot Number: 01A ",".","1","Micro SSP DNA Typing Trays of HLA Class I and Class II alleles, where null allele entries were not properly verified and may cause misassignment, were distributed. ",2/21/2013,"02/21/2013",5/15/2013,"05/15/2013"
"Biologics",32603,"Ongoing","One Lambda Inc","Canoga Park","CA","US","Voluntary: Firm Initiated","Letter","US states nationwide. International: Canada, U.A.E, Saudi Arabia, Cyprus, UK, France, Germany, Greece, Israel, Italy, S.Africa, Jordan, Kuwait, Lebanon, Poland, Serbia, Croatia, Seria, Montenegro, Austria, Netherlands, Russia, Finland, Spain & Portugal, Turkey, Russia, Finland, Brazil, Argentina, Australia, Qatar, Bangladesh, Korea, China, Chile, Bolivia, Paraguay, Costa Rica, Ecuador, Guatemala, India, Japan, Mexico, Malaysia, New Zealand, Peru Philippines, Pakistan.","B-1425-13","Class III","Micro SSP DNA Typing Trays Micro SSP Generic HLA Class II DNA Typing Tray Article Number: SSP_DNAT_PI Rev 18 510(K) Number : BK960062 ","Catalog Identification: SSP2L Lot Number: 007 ",".","1","Micro SSP DNA Typing Trays of HLA Class I and Class II alleles, where null allele entries were not properly verified and may cause misassignment, were distributed. ",2/21/2013,"02/21/2013",5/15/2013,"05/15/2013"
"Biologics",32603,"Ongoing","One Lambda Inc","Canoga Park","CA","US","Voluntary: Firm Initiated","Letter","US states nationwide. International: Canada, U.A.E, Saudi Arabia, Cyprus, UK, France, Germany, Greece, Israel, Italy, S.Africa, Jordan, Kuwait, Lebanon, Poland, Serbia, Croatia, Seria, Montenegro, Austria, Netherlands, Russia, Finland, Spain & Portugal, Turkey, Russia, Finland, Brazil, Argentina, Australia, Qatar, Bangladesh, Korea, China, Chile, Bolivia, Paraguay, Costa Rica, Ecuador, Guatemala, India, Japan, Mexico, Malaysia, New Zealand, Peru Philippines, Pakistan.","B-1426-13","Class III","Micro SSP DNA Typing Trays Micro SSP Generic HLA Class II DNA Typing Tray - DRB Only Article Number: SSP_DNAT_PI Rev 18 510(K) Number : BK960062 ","Catalog Identification: SSP2LB Lot Number: 004 ",".","1","Micro SSP DNA Typing Trays of HLA Class I and Class II alleles, where null allele entries were not properly verified and may cause misassignment, were distributed. ",2/21/2013,"02/21/2013",5/15/2013,"05/15/2013"
"Devices",33728,"Ongoing","Aperio Technologies Inc","Vista","CA","US","Voluntary: Firm Initiated","Letter","Nationwide Distribution - including all states, none internationally .","Z-1549-2013","Class II","Aperio ScanScope System. Aperio ScanScope Models, XT, AT, AT Turbo, CS and CSO. Automated digital slide creation and viewing device. It is intended to create and view electronic image files representative of tissue specimens fixed to glass slides.","The following serial numbers of the Aperio ScanScope systems are affected in the USA by this recall: ScanScope XT ScanScope AT ScanScope ATT ScanScope es, esa 1223, 1273, 1278, 1277, 1282, 1593,1605, 1648,1657,1660, 5064,5068,5108,5155,5170,5171 1285,1286,1287,1293,1296, 1619, 1620, 1662,1663,1666, 5176,5181,5187,5196,5198,5202, 1299,1300,1301,1302,1304, 1623, 1633, 1671, 1672, 1673, 5204,5205,5233,5236,5237,5241, 1311,1312,1314,1315,1316, 1634,1635, 1676, 1678, 1679, 5244,5245,5246,5248,5253,5262, 1318,1319,1320,1321,1322, 1636, 1637, 1690, 1692, 1695, 5266,5267,5269,5270,5272,5276, 1324,1325,1327,1328,1330, 1638,1640, 1698,1700,1718 5277,5279,5283,5287,5288,5293, 1332, 1333, 1335, 1336, 1338, 1643,1645, 5294, 5295, 5302, 5307, 5308, 5309, 1339, 1340, 1342, 1343, 1345, 1649,1654, 5314,5315,5316,5317,5324,5327, 1350,1352,1357,1358,1359, 1656,1664, 5328,5329,5330,5331,5333,5334, 1366, 1368, 1369, 1370, 1372, 1686, 1687, 5336,5339,5340,5341,5345,5347, 1382,1383,1392,1394,1396, 1688, 1689, 5348,5352,5353,5356,5367,5371, 1397, 1399, 1400, 1402, 1404, 1696, 1699, 5374,5379,5381,5388,5390,5394, 1405,1407,1409,1410,1413, 1703,1705, 5396,5402,5403,5404,5405,5406, 1417,1418,1419,1420,1421, 1707, 1708, 5408,5409,5415,5416,5418,5419, 1422, 1423, 1424, 1425, 1426, 1709,1711, 5433,5440,5452,5456,5457,5459, 1436,1441,1442,1444,1445, 1714,1716, 5462,5465,5466,5467,5468,5469, 1446, 1448, 1449, 1450, 1452, 1719,1721, 5470,5473,5475,5476,5477,5478, 1453, 1454, 1456, 1457, 1458, 1723,1724, 5482,5485,5486,5489,5490,5492, 1460,1461,1466,1475,1476, 1725,1727, 5493,5504,5515,5516,5517,5518, 1481,1482,1486,1487,1490, 1728,1729, 5520, 5529, 5537, 5540, 5552, 5566, 1492, 1499, 1500, 1502, 1503, 1731,1733, 5567,5574,5578,5581,5587,5590, 1505,1506,1507,1508,1509, 1735, 1736, 5591,5592,5593 1511,1512,1514,1515,1516, 1739,1744 1517,1519,1520,1522,1523, 1525, 1527, 1",,"364","Aperio initiated this recall because the User Guides incorrectly state the devices had been cleared for specific applications. The User Guides should state the devices are for Research Use Only and are not for use in diagnostic procedures.",2/22/2013,"02/22/2013",6/26/2013,"06/26/2013"
"Biologics",34083,"Terminated","American National Red Cross, The","Pomona","CA","US","Voluntary: Firm Initiated","Letter","CA","B-2468-13","Class II","Red Blood Cells Leukocytes Reduced","06GS92453",,"1 unit","Blood product, collected from a donor who traveled to an area considered endemic for malaria, was distributed.",10/5/2004,"10/05/2004",11/6/2013,"11/06/2013"
"Biologics",34086,"Terminated","Blood Bank Of San Bernardino And Riverside Counties","San Bernardino","CA","US","Voluntary: Firm Initiated","Telephone","California","B-2563-13","Class II","Platelet Apheresis","GS34744",,"1","Blood product, with insufficient plasma to support the platelet yield, was distributed.",5/19/2003,"05/19/2003",11/27/2013,"11/27/2013"
"Biologics",34089,"Terminated","Hemacare Corporation","Van Nuys","CA","US","Voluntary: Firm Initiated","Letter","CA","B-2557-13","Class II","Red Blood Cells Leukocytes reduced","4898171",".","1 unit","Blood product, collected from a donor who tested reactive for the antibody to hepatitis B core antigen on two separate occasions, was distributed.",2/5/2003,"02/05/2003",11/20/2013,"11/20/2013"
"Food",34820,"Ongoing","G.L. Food Wholesale Inc","City Of Industry","CA","US","Voluntary: Firm Initiated","Letter","CA, TX, IL, NV, OR, AZ, MO, NM, WA","F-1200-2013","Class III","Tausi Brand Salted Black Beans, 180g (6.34oz), 100 cans/carton This product is in a two piece can with a single seam. This 6.34 oz can is wrapped with a label containing, red, yellow, and black text labeled in part ''Tausi Brand Salted Black Beans***Distributed by: V8 Commercial Co, Inc. San Juan, Metro Manila Produc of the Phillipines***Ingredients: Black Beans, water, Iodized salt, sugar and caramel Net wt. 180g(6.34oz)**BB:___''","BB Sept 21, 2013BB Nov 26, 2013 BB Nov 27, 2013 BB Nov 20, 2013 BB Feb 29, 2013",,"350 cases","GL Food Wholesale is recalling Tausi Brand Salted Black Beans because it may have the potential for pathogen growth and toxin formation due to Clostridium botulinum or other spoilage organisms.",1/16/2013,"01/16/2013",3/20/2013,"03/20/2013"
"Food",34821,"Terminated","Golden Dharma International Corp","Rowland Heights","CA","US","Voluntary: Firm Initiated","Letter","California, New Jersey","F-1131-2013","Class III","Tausi Brand Salted Black Beans, 180g (6.34oz), 100 cans/carton This product is in a two piececan with a single seam. This 6.34 oz can is wrapped with a label containing, red, yellow, and black text labeled in part ''Tausi Brand Salted Black Beans***Distributed by: V8 Commercial Co, Inc. San Juan, Metro Manila Produc of the Phillipines***Ingredients: Black Beans, water, Iodized salt, sugar and caramel Net wt. 180g(6.34oz)**BB:___''","BB Apr 26, 2013BB May 24, 2013",,"910 cartons","Golden Dharma International is recalling Tausi Brand Salted Black Beans because it may have the potential forpathogen growth and toxin formation due to Clostridium botulinum or other spoilage organisms.",1/18/2013,"01/18/2013",3/20/2013,"03/20/2013"
"Biologics",35757,"Terminated","Tri-counties Blood Bank","San Luis Obispo","CA","US","Voluntary: Firm Initiated","Telephone","CA","B-1966-13","Class II","Red Blood Cells (Apheresis) Leukocytes Reduced","LF32600",".","1 unit","Blood product, for which the quality control testing for red blood cell volume was not performed, was distributed.",3/15/2005,"03/15/2005",8/14/2013,"08/14/2013"
"Food",35761,"Ongoing","Mandalay Trading Corporation","City of Industry","CA","US","Voluntary: Firm Initiated","Letter","CA, NV, NM, WA, GA, NJ,","F-1199-2013","Class III","Tausi Brand Salted Black Beans, 180g (6.34oz), 100 cans/carton This product is in a two piece can with a single seam. This 6.34 oz can is wrapped with a label containing, red, yellow, and black text labeled in part ''Tausi Brand Salted Black Beans***Distributed by: V8 Commercial Co, Inc. San Juan, Metro Manila Produc of the Phillipines***Ingredients: Black Beans, water, Iodized salt, sugar and caramel Net wt. 180g(6.34oz)**BB:___''","BB Mar 16, 2014BB Mar 17, 2014 BB Mar 20, 2014 BB Aug 14, 2014 BB Sept 11, 2014 BB Sept 12, 2014",,"530 cartons","Mandalay Trading is recalling Tausi Brand Salted Black Beans because it may have the potential for pathogen growth and toxin formation due to Clostridium botulinum or other spoilage organisms.",1/25/2013,"01/25/2013",3/20/2013,"03/20/2013"
"Food",35779,"Ongoing","Walong Marketing, Inc.","Buena Park","CA","US","Voluntary: Firm Initiated","Letter","nationwide","F-1132-2013","Class III","Tausi Brand Salted Black Beans, 180g (6.34oz), 100 cans/carton This product is in a two piece can with a single seam. This 6.34 oz can is wrapped with a label containing, red, yellow, and black text labeled in part ''Tausi Brand Salted Black Beans***Distributed by: V8 Commercial Co, Inc. San Juan, Metro Manila Produc of the Phillipines***Ingredients: Black Beans, water, Iodized salt, sugar and caramel Net wt. 180g(6.34oz)**BB:___''","all lots",,"650 cartons","Walong is recalling Tausi Brand Salted Black Beans because it may have the potential for pathogen growth and toxin formation due to Clostridium botulinum or other spoilage organisms.",1/17/2013,"01/17/2013",3/20/2013,"03/20/2013"
"Food",35782,"Terminated","Altiza Inc.","Chula Vista ","CA","US","Voluntary: Firm Initiated","Telephone","CA","F-0984-2013","Class I","Cucumbers, 44 lbs/box. Brand: Malichita (green, yellow, red and white background color on each cartons)","Lot #MA012304.",,"343 units","Altiza is recalling Malichita brand cucumbers because they may be contaminated with Salmonella.",1/28/2013,"01/28/2013",2/20/2013,"02/20/2013"
"Food",35908,"Terminated","Man Fon Inc","San Gabriel","CA","US","Voluntary: Firm Initiated","Press Release","TX","F-0979-2013","Class II","Yangchun Noodles, 10 case, 12 bgs per case","no lot number available",,"120 units","Man Fon is recalling Yangchun Noodles because they contain undeclared wheat allergen.",1/8/2013,"01/08/2013",2/13/2013,"02/13/2013"
"Biologics",36297,"Terminated","South Florida Blood Banks, Inc.","Palm Beach Gardens","FL","US","Voluntary: Firm Initiated","Letter","Florida","B-0084-14","Class II","Platelets"," 9745660",".","1","Blood products, collected from donors, whose suitability to donate was not adequately determined, were distributed.",10/27/2004,"10/27/2004",10/30/2013,"10/30/2013"
"Biologics",36297,"Terminated","South Florida Blood Banks, Inc.","Palm Beach Gardens","FL","US","Voluntary: Firm Initiated","Letter","Florida","B-0085-14","Class II","Fresh Frozen Plasma"," 9745660",".","1","Blood products, collected from donors, whose suitability to donate was not adequately determined, were distributed.",10/27/2004,"10/27/2004",10/30/2013,"10/30/2013"
"Biologics",36297,"Terminated","South Florida Blood Banks, Inc.","Palm Beach Gardens","FL","US","Voluntary: Firm Initiated","Letter","Florida","B-0083-14","Class II","Red Blood Cells Leukocytes Reduced"," 9745660",".","1","Blood products, collected from donors, whose suitability to donate was not adequately determined, were distributed.",10/27/2004,"10/27/2004",10/30/2013,"10/30/2013"
"Biologics",37111,"Terminated","Blood Bank Of San Bernardino and Riverside Counties","San Bernardino","CA","US","Voluntary: Firm Initiated","Telephone","CA","B-2565-13","Class II","Leuko-reduced red cells","GZ02161",,"1 unit","Blood product, collected from a donor who reported post donation illness, was distributed.",1/10/2006,"01/10/2006",11/27/2013,"11/27/2013"
"Devices",37530,"Completed","Radiometer America Inc","Westlake","OH","US","Voluntary: Firm Initiated","Letter","Distributed to KY, NC, and NY.","Z-0608-2013","Class III","Qualicheck 1+, Aqueous Quality Control, Level 2, S7140, REF 944-042. The solution is used for quality check of blood gas analyzers.","Lot R0040, expiration date February 2008; Lot R0042, expiration date April 2008.",".","840 Ampules","The barcode for the ABL77 on the insert incorrectly enters a control range for pH of 7.90-7.95 into the analyzer. The insert correctly states that the control range is 7.40-7.45.",6/6/2006,"06/06/2006",1/2/2013,"01/02/2013"
"Biologics",38551,"Terminated","Penrose-St Franc Health Services Blood Bank","Colorado Springs","CO","US","Voluntary: Firm Initiated","FAX","CO","B-0175-13","Class III","Blood and Blood Products for reprocessing","2284245; 2285158",".","2","Blood products, collected from a donor who was not asked follow-up questions regarding increased risk for vCJD, were distributed.",2/16/2009,"02/16/2009",1/23/2013,"01/23/2013"
"Biologics",38561,"Terminated","LifeSouth Community Blood Centers, Inc.","Gainesville","FL","US","Voluntary: Firm Initiated","FAX","FL","B-0924-13","Class II","Fresh Frozen Plasma (Apheresis)","71X52474 part 1",,"1 unit","Blood products, collected in a manner that may have compromised the sterility of the collection system, were distributed.",3/9/2007,"03/09/2007",5/22/2013,"05/22/2013"
"Biologics",38565,"Terminated","Blood Center of Central Iowa (The)","Des Moines","IA","US","Voluntary: Firm Initiated","Letter","IA","B-0762-13","Class II","Red Blood Cells (Apheresis) Leukocytes Reduced","V10279A; V10279B",".","2","Blood products, which were collected from a donor who had traveled to a malarial endemic area, were distributed.",3/6/2007,"03/06/2007",3/27/2013,"03/27/2013"
"Biologics",38566,"Terminated","Blood Center of Central Iowa (The)","Des Moines","IA","US","Voluntary: Firm Initiated","Other","unknown","B-0863-13","Class II","Blood and Blood Products for Reprocessing","LT94863",,"1 unit","Blood products, collected from a donor who was at risk for variant Creutzfeldt-Jakob disease (vCJD), were distributed.",4/19/2007,"04/19/2007",4/3/2013,"04/03/2013"
"Biologics",38567,"Terminated","Blood Center of Central Iowa (The)","Des Moines","IA","US","Voluntary: Firm Initiated","Letter","PA","B-0876-13","Class III","Red Blood Cells","KX15411",,"1 unit","Blood product, collected from a donor with a history of surgery within 12 months, was distributed.",4/19/2007,"04/19/2007",4/3/2013,"04/03/2013"
"Biologics",38568,"Terminated","Blood Center of Central Iowa (The)","Des Moines","IA","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","IA","B-0868-13","Class II","Red Blood Cells Leukocytes Reduced","FC11222; LF14391",,"2 units","Blood products, collected from a donor who was taking Prednisone, were distributed.",4/19/2007,"04/19/2007",4/3/2013,"04/03/2013"
"Biologics",38569,"Terminated","Tri-counties Blood Bank","San Luis Obispo","CA","US","Voluntary: Firm Initiated","Letter","California","B-1925-13","Class II","Red Blood Cells Leukocytes Reduced","FZ77035",".","1 unit","Blood product, collected from a donor who traveled to an area considered endemic for malaria, was distributed.",5/22/2007,"05/22/2007",8/14/2013,"08/14/2013"
"Biologics",38570,"Terminated","Tri-counties Blood Bank","San Luis Obispo","CA","US","Voluntary: Firm Initiated","Letter","California","B-1924-13","Class II","Red Blood Cells Leukocytes Reduced","FZ85617",".","1 unit","Blood product, collected from a donor who traveled to an area considered endemic for malaria, was distributed.",5/22/2007,"05/22/2007",8/14/2013,"08/14/2013"
"Biologics",38571,"Terminated","Tri-counties Blood Bank","San Luis Obispo","CA","US","Voluntary: Firm Initiated","Telephone","California","B-1965-13","Class II","Platelets Pheresis Leukocytes Reduced Irradiated","GW97725",".","1 unit","Blood product, which may have been out of controlled storage for greater than 30 minutes, was distributed.",5/4/2007,"05/04/2007",8/14/2013,"08/14/2013"
"Biologics",38572,"Terminated","Tri-counties Blood Bank","San Luis Obispo","CA","US","Voluntary: Firm Initiated","Letter","California","B-1923-13","Class II","Red Blood Cells Leukocytes Reduced","FZ80940, FZ84236",".","2 units","Blood products, collected from a donor who traveled to an area considered endemic for malaria, were distributed.",7/12/2007,"07/12/2007",8/14/2013,"08/14/2013"
"Biologics",38573,"Terminated","Tri-Counties Blood Bank dba UBS- Central Coast","Santa Barbara","CA","US","Voluntary: Firm Initiated","Letter","CA","B-1848-13","Class II","Red Blood Cells Leukocytes Reduced Irradiated","FZ84753; FZ67148",,"2 units","Blood products, which were collected from a donor who traveled to a malarial endemic area, were distributed. ",6/29/2007,"06/29/2007",9/4/2013,"09/04/2013"
"Biologics",38573,"Terminated","Tri-Counties Blood Bank dba UBS- Central Coast","Santa Barbara","CA","US","Voluntary: Firm Initiated","Letter","CA","B-1848-13","Class II","Red Blood Cells Leukocytes Reduced Irradiated","FZ84753; FZ67148",".","2 units","Blood products, which were collected from a donor who traveled to a malarial endemic area, were distributed. ",6/29/2007,"06/29/2007",9/11/2013,"09/11/2013"
"Biologics",38596,"Terminated","American National Red Cross (The)","West Henrietta","NY","US","Voluntary: Firm Initiated","Letter","PA, NY","B-1310-13","Class II","Red Blood Cells","01E91917",".","1 unit","Blood products, which were collected from a donor who traveled to a malarial endemic area, were distributed.",4/26/2007,"04/26/2007",5/29/2013,"05/29/2013"
"Biologics",38597,"Terminated","American National Red Cross (The)","West Henrietta","NY","US","Voluntary: Firm Initiated","FAX","New York","B-1337-13","Class II","Red Blood Cells Leukocytes Reduced","01LJ41562",".","1 component ","Blood product, collected from a donor who reported travel to a malarial endemic area, was distributed.",6/18/2007,"06/18/2007",6/5/2013,"06/05/2013"
"Biologics",38693,"Terminated","American National Red Cross (The)","Salt Lake City","UT","US","Voluntary: Firm Initiated","FAX","AZ, CA, ID, MD, MI, NV, OK, OR, PA, TN, UT.","B-1469-13","Class II","Red Blood Cells Leukocytes Reduced","20E63815; 20E63822; 20E63825; 20E63828; 20E63829; 20E63835; 20E63837; 20E63843; 20E63846; 20E63857; 20E63859; 20E63872; 20E64720; 20E64725; 20E64736; 20E64739; 20KK46992; 20KK46993; 20KK46995; 20KK46999; 20KK47000; 20KK47003; 20KK47004; 20KK47006; 20KK47007; 20KK47164; 20KK47165; 20KK47171; 20KK47178; 20KK47181; 20KK47182; 20KV12550; 20KV12559; 20KV12563; 20KV12567; 20KV12575; 20KV12586; 20KV12591; 20KV12690; 20KV12692; 20KV12694; 20KV12696; 20KV12698; 20KV12700; 20KV12702; 20KV12705; 20KV12708; 20KV12709; 20KV12742; 20KV12744; 20KV12746; 20KV12748; 20KV12754; 20KV12755; 20KV12759; 20KV12762; 20KV12766; 20KV12767; 20KV12771; 20KV12774; 20KV13089; 20KV13091; 20KV13096; 20KV13102; 20KV13110; 20KV13111; 20KV13113; 20KV13116; 20KV13502; 20KV13506; 20KV13508; 20KV13514; 20KV13515; 20KV13523; 20M52063; 20M52065; 20M52067; 20M52069; 20M52071; 20T91830; 20T91832; 20T91834; 20T91837; 20T91839; 20T91842; 02T91846; 20T91848; 20T91851; 20T91885; 20T91890; 20T91895; 20T91897; 20T91901; 20T91905; 20T91911; 20T92191; 20T92194; 20T92126; 20T92193; 20T92199; 20T92201; 20T92225; 20T92226; 20T92234; 20T92239; 20T92241; 20T92248; 20T92249; 20T92253; 20T92255; 20T92260; 20T92261; 20T92328; 20T92334; 20T92341; 20T92345; 20T92348; 20T92355; 20T92356; 20T92967; 20X33983; 20X33985; 20X33989; 20X33991; 20X33995; 20X33998; 20X34006; 20X34873; 20X34875; 20X34876; 20X34879; 20X34880; 20X34885; 20X34888; 20X34894; 20X34899; 20X34906; 20X34974; 20X34976; 20X34979; 20X34983; 20X34985; 20X34987; 2034991; 20X35237; 20X35242; 20X35246; 20X35253; 20X35296; 20X35305; 20X35307; 20X35313; 20X35315; 20X35319; 20X35615; 20Z28093; 20Z28098; 20Z28101; 20Z28103; 20Z28105; 20Z28108; 20Z28116; 20Z28128; 20Z28131; 20Z28723; 20Z28725; 20Z28733; 20Z28741; 20Z28747; 20Z28726; ",,"170 units","Blood products, collected from donors whose arm scrub procedures were performed incorrectly, were distributed.",3/9/2007,"03/09/2007",6/26/2013,"06/26/2013"
"Biologics",38693,"Terminated","American National Red Cross (The)","Salt Lake City","UT","US","Voluntary: Firm Initiated","FAX","AZ, CA, ID, MD, MI, NV, OK, OR, PA, TN, UT.","B-1470-13","Class II","Plasma Frozen","20KV12591; 20KV12696; 20KV12759; 20KV13110; 20KV13113; 20T92196; 20T92201; 20X33985; 20X33991; 20X33995; 20X33998; 20X34006; 20Z28093; 20Z28113; 20Z28128; 20Z28131",,"16 ","Blood products, collected from donors whose arm scrub procedures were performed incorrectly, were distributed.",3/9/2007,"03/09/2007",6/26/2013,"06/26/2013"
"Biologics",38756,"Terminated","The American National Red Cross - Southern Region","Douglasville","GA","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","GA","B-0875-13","Class III","Red Blood Cells (Apheresis) Leukocytes Reduced","003GJ84411 (part 1); 003GJ84411 (part 2)",,"2 units","Blood products, collected under conditions where the sterility of the products may have been compromised, were distributed.",5/9/2007,"05/09/2007",4/3/2013,"04/03/2013"
"Biologics",38777,"Terminated","American National Red Cross (The)","Louisville","KY","US","Voluntary: Firm Initiated","Letter","KY","B-1920-13","Class II","Red Blood Cells (Apheresis) Leukocytes Reduced. ","24FP04503; 24FP04503",".","2 components","Blood products, held in quarantine pending results of an investigation, were distributed",5/31/2007,"05/31/2007",8/14/2013,"08/14/2013"
"Biologics",38780,"Terminated","Csl Plasma","Dayton","OH","US","Voluntary: Firm Initiated","E-Mail","Germany, Ilinios","B-1564-13","Class II","Source Plasma","4080095992, 4080114685, 4080107999, 4080106384, 4080105847, 4080098437, 4080096586",".","7 units","Blood products, collected from a donor who did not have a complete physical examination, were distributed.",3/28/2007,"03/28/2007",8/14/2013,"08/14/2013"
"Biologics",38781,"Terminated","Csl Plasma","Dayton","OH","US","Voluntary: Firm Initiated","E-Mail","IL","B-1957-13","Class II","Source Plasma","4080141558, 4080140651, 4080140149, 4080127236, 4080125772, 4080124313, 4080123731",".","7 units","Blood products, collected from a donor who did not have a complete physical examination, were distributed.",6/13/2007,"06/13/2007",8/14/2013,"08/14/2013"
"Biologics",38800,"Terminated","American National Red Cross (The)","Cleveland","OH","US","Voluntary: Firm Initiated","Telephone","OH","B-1959-13","Class II","Platelets Pooled Leukocytes Reduced","042K90931 (pool 1997)",".","1 unit","Blood products, collected from a donor for whom donor suitability was not adequately determined, were distributed.",3/28/2007,"03/28/2007",8/14/2013,"08/14/2013"
"Biologics",38800,"Terminated","American National Red Cross (The)","Cleveland","OH","US","Voluntary: Firm Initiated","Telephone","OH","B-1960-13","Class II","Plasma Frozen","042K90931",".","1 unit","Blood products, collected from a donor for whom donor suitability was not adequately determined, were distributed.",3/28/2007,"03/28/2007",8/14/2013,"08/14/2013"
"Biologics",38800,"Terminated","American National Red Cross (The)","Cleveland","OH","US","Voluntary: Firm Initiated","Telephone","OH","B-1958-13","Class II","Red Blood Cells Leukocytes Reduced","042K90931",".","1 unit","Blood products, collected from a donor for whom donor suitability was not adequately determined, were distributed.",3/28/2007,"03/28/2007",8/14/2013,"08/14/2013"
"Biologics",38801,"Terminated","American National Red Cross (The)","Cleveland","OH","US","Voluntary: Firm Initiated","Telephone","OH, CA","B-1963-13","Class III","Recovered Plasma","42X20495",".","1 unit","Blood products, collected from a donor for whom donor suitability was not adequately determined, were distributed.",4/3/2007,"04/03/2007",8/14/2013,"08/14/2013"
"Biologics",38801,"Terminated","American National Red Cross (The)","Cleveland","OH","US","Voluntary: Firm Initiated","Telephone","OH, CA","B-1962-13","Class II","Platelets Leukocytes Reduced","42X20495",".","1 unit","Blood products, collected from a donor for whom donor suitability was not adequately determined, were distributed.",4/3/2007,"04/03/2007",8/14/2013,"08/14/2013"
"Biologics",38801,"Terminated","American National Red Cross (The)","Cleveland","OH","US","Voluntary: Firm Initiated","Telephone","OH, CA","B-1961-13","Class II","Red Blood Cells Leukocytes Reduced","42X20495",".","1 unit","Blood products, collected from a donor for whom donor suitability was not adequately determined, were distributed.",4/3/2007,"04/03/2007",8/14/2013,"08/14/2013"
"Biologics",38803,"Terminated","American National Red Cross (The)","Cleveland","OH","US","Voluntary: Firm Initiated","Telephone","Ohio, Switzerland","B-2243-13","Class III","Recovered Plasma","42FT70229, 42FT70246, 42FT70255, 42FT70267, 42FT70306, 42FX56668, 42FX56674, 42FX56676, 42FX56684, 42FX56690",".","10 units","Blood products, collected in a manner that may have compromised the sterility of the units, were distributed.",3/1/2007,"03/01/2007",9/11/2013,"09/11/2013"
"Biologics",38803,"Terminated","American National Red Cross (The)","Cleveland","OH","US","Voluntary: Firm Initiated","Telephone","Ohio, Switzerland","B-2242-13","Class II","Platelets Pooled Leukocytes Reduced","42FT70246, 42FT70255, 42FT70306, 42FX56668, 42FX56674, 42FX56684, 42FX56690",".","7 units","Blood products, collected in a manner that may have compromised the sterility of the units, were distributed.",3/1/2007,"03/01/2007",9/11/2013,"09/11/2013"
"Biologics",38803,"Terminated","American National Red Cross (The)","Cleveland","OH","US","Voluntary: Firm Initiated","Telephone","Ohio, Switzerland","B-2241-13","Class II","Red Blood Cells Leukocytes Reduced","42FT70229, 42FT70233, 42FT70246, 42FT70255, 42FT70267, 42FT70306, 42FX56668, 42FX56674, 42FX56676, 42FX56684, 42FX56690",".","11 units","Blood products, collected in a manner that may have compromised the sterility of the units, were distributed.",3/1/2007,"03/01/2007",9/11/2013,"09/11/2013"
"Biologics",38808,"Terminated","American National Red Cross (The)","Cleveland","OH","US","Voluntary: Firm Initiated","Telephone","OH, CA","B-2027-13","Class II","Red Blood Cells Leukocytes Reduced","42FX51417, 42M22729",".","2 units","Blood products, collected from a donor for whom donor suitability was not adequately determined, were distributed.",6/5/2007,"06/05/2007",8/14/2013,"08/14/2013"
"Biologics",38808,"Terminated","American National Red Cross (The)","Cleveland","OH","US","Voluntary: Firm Initiated","Telephone","OH, CA","B-2029-13","Class III","Recovered Plasma","42FX51417, 42M22729",".","2 units","Blood products, collected from a donor for whom donor suitability was not adequately determined, were distributed.",6/5/2007,"06/05/2007",8/14/2013,"08/14/2013"
"Biologics",38808,"Terminated","American National Red Cross (The)","Cleveland","OH","US","Voluntary: Firm Initiated","Telephone","OH, CA","B-2028-13","Class II","Platelets Leukocytes Reduced","42FX51417, 42M22729",".","2 units","Blood products, collected from a donor for whom donor suitability was not adequately determined, were distributed.",6/5/2007,"06/05/2007",8/14/2013,"08/14/2013"
"Biologics",38820,"Terminated","Talecris Plasma Resources, Inc.","Research Triangle Park","NC","US","Voluntary: Firm Initiated","FAX","NC","B-0136-14","Class II","Source Plasma","372083439, 372078475, 372086936, 372086362, 372084077, 372082405, 372081944, 372079984, 372079090, 372081065, 372076885, 372076405, 372075324, 372074827, 372073497, 372070194, 372069368, 372067971, 372067072, 372046115, 372044282, 372043673, 372042681, 372041350, 372039384, 372038239, 372036736, 372036294",,"28 units","Blood products, collected from a donor who did not have a complete physical examination, were distributed.",3/20/2007,"03/20/2007",12/18/2013,"12/18/2013"
"Biologics",38821,"Terminated","Talecris Plasma Resources, Inc.","Research Triangle Park","NC","US","Voluntary: Firm Initiated","FAX","NC","B-1140-13","Class II","Source Plasma","372096384; 372095334; 372094672; 372093645; 372093052; 372092045; 372090293; 372088790; 372088180; 372087073; 372086472; 372085212; 372084648; 372082085; 372081677; 372080542; 372077876; 372077265; 372075681; 372075140; 372073882; 372073290; 372071702; 372071102; 372069488; 372067904; 372067296; 372066247; 372065681; 372064593; 372063947; 372062884; 372062252; 372059770; 372059081; 372057615; 372056898; 372055988; 372055497; 372054548; 372053473; 372049013; 372048030 ",,"43","Blood products, collected from a donor whose scheduled physical examination was incomplete, were distributed.",4/10/2007,"04/10/2007",5/22/2013,"05/22/2013"
"Biologics",38822,"Terminated","BioLife Plasma Services L.P.","Deerfield","IL","US","Voluntary: Firm Initiated","FAX","CA","B-0410-13","Class II","Source Plasma","06DTXA8078;06DTXA8396;06DTXA9188;06DTXB1558;06DTXB2400;06DTXB3165;06DTXC1480;06DTXC1932;06DTXC2667;06DTXC2894;06DTXC3340;06DTXC4214;06DTXC4645;06DTXC4859;06DTXC5314;;06DTXC5567;06DTXC5928;06DTXC6248;06DTXC6528;06DTXC6853;06DTXC7162;06DTXC7518;06DTXC7742;06DTXC8149;06DTXC8428;06DTXC8974;06DTXC9161;06DTXC9715;06DTXC9887;06DTXD0443;06DTXD0658;06DTXD1174;06DTXD1404;06DTXD2067;06DTXD2598;06DTXD2753;06DTXD3043;06DTXD3244;06DTXA3551;06DTXA3989;06DTXA1898;06DTXA4370;06DTXD3679;06DTXD3896;06DTXD4526;06DTXD4986;06DTXD5561;06DTXD5779;07DTXA0133;07DTXA0342;07DTXA4053;07DTXA1332;07DTXA1781;07DTXA1950;07DTXA2300;07DTXA2450;07DTXA2814;07DTXA2996;07DTXA3401;07DTXA3518;07DTXA0549;07DTXA0865.",,"62 Units","Blood products, collected from a donor who was at risk for variant Creutzfeldt-Jakob disease (vCJD), were distributed.",3/15/2007,"03/15/2007",2/20/2013,"02/20/2013"
"Biologics",38834,"Terminated","Blood Systems, Inc.","El Paso","TX","US","Voluntary: Firm Initiated","Other","Switzerland","B-0817-13","Class II","Blood and Blood Products for Reprocessing","112538839;119944156;119936451",,"3","Blood products, collected from a donor considered to be at increased risk for variant Creutzfeldt-Jakob Disease (vCJD), were distributed.",3/12/2007,"03/12/2007",4/3/2013,"04/03/2013"
"Biologics",38910,"Terminated","ARC Blood Services, New England Region","Dedham","MA","US","Voluntary: Firm Initiated","Letter","CA, MA, ME, NH, NY","B-0369-13","Class II","Red Blood Cells Rejuvenated Irradiated ","04FJ19207, 04FJ19217, 04FJ19220, 04FJ19224. 04FJ19230, 04FJ19476,04FJ19487, 04FJ19595, 04FJ19601 ",".","9","Blood products, collected from donors, whose suitability to donate was not adequately determined, were distributed",6/13/2007,"06/13/2007",1/23/2013,"01/23/2013"
"Biologics",38910,"Terminated","ARC Blood Services, New England Region","Dedham","MA","US","Voluntary: Firm Initiated","Letter","CA, MA, ME, NH, NY","B-0368-13","Class II","Red Blood Cells Leukocytes Reduced Plasma Frozen","04FF62346, 04FF62348, 04FF62357, 04FF62358, 04FF62362, 04FF62364, 04FF62373, 04FF62376, 04FF62386, 04FF62389, 04FF62393, 04FF62402, 04FF62403, 04FF62405, 04FF62407, 04FF62412, 04FF62419, 04FF62421, 04FF62424, 04FF62426, 04FF62525, 04FF62530, 04FJ19204, 04FJ19228, 04FJ19233, 04FJ19236, 04FJ19245, 04FJ19247, 04FJ19253, 04FJ19263, 04FJ19270, 04FJ19272, 04FJ19277, 04FJ19281, 04FJ19284, 04FJ19295, 04FJ19297, 04FJ19303, 04FJ19312, 04FJ19317, 04FJ19324, 04FJ19333, 04FJ19337, 04FJ19488, 04FJ19500, 04FJ19505, 04FJ19507, 04FJ19591, ",".","48","Blood products, collected from donors, whose suitability to donate was not adequately determined, were distributed",6/13/2007,"06/13/2007",1/23/2013,"01/23/2013"
"Biologics",38910,"Terminated","ARC Blood Services, New England Region","Dedham","MA","US","Voluntary: Firm Initiated","Letter","CA, MA, ME, NH, NY","B-0371-13","Class III","Blood and Blood Products for Reprocessing","04FF62350, 04FF62352, 04FF62357, 04FF62358, 04FF62376, 04FF62386,04FF62396, 04FF62405, 04FF62407,04FF62421, 04FF62424, 04FJ19204, 04FJ19228, 04FJ19230, 04FJ19233, 04FJ19245, 04FJ19270, 04FJ19272,04FJ19277. 04FJ19284, 04FJ19295, 04FJ19317, 04FJ19333, 04FJ19495 04FJ19500, 04FJ19504, 04FJ19507 ",".","27","Blood products, collected from donors, whose suitability to donate was not adequately determined, were distributed",6/13/2007,"06/13/2007",1/23/2013,"01/23/2013"
"Biologics",38910,"Terminated","ARC Blood Services, New England Region","Dedham","MA","US","Voluntary: Firm Initiated","Letter","CA, MA, ME, NH, NY","B-0370-13","Class II","Plasma Frozen","04FF62362,04FF62364,04FJ19247,04FJ19324 ",".","4","Blood products, collected from donors, whose suitability to donate was not adequately determined, were distributed",6/13/2007,"06/13/2007",1/23/2013,"01/23/2013"
"Biologics",39044,"Terminated","Florida Blood Services, Inc.","St Petersburg","FL","US","Voluntary: Firm Initiated","Telephone","Florida","B-1702-13","Class II","Red Blood Cells.","5318209",".","1 unit","Blood product, incorrectly labeled as negative for the Jka red cell antigen, was distributed.",5/4/2007,"05/04/2007",7/24/2013,"07/24/2013"
"Biologics",39047,"Terminated","Northwest Florida Blood Center, Inc.","Pensacola","FL","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Florida","B-1311-13","Class III","Red Blood Cells (Apheresis) Leukocytes Reduced","4565963A; 4565963B; 4565953A; 4565953B",".","4 units","Blood products, which were labeled with an incorrect volume, were distributed.",12/28/2006,"12/28/2006",5/29/2013,"05/29/2013"
"Biologics",39050,"Terminated","Northwest Florida Blood Center, Inc.","Pensacola","FL","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Florida","B-1241-13","Class II","Red Blood Cells (Apheresis) Leukocytes Reduced.","4092092",".","1 unit","Blood products, collected from a donor who received a piercing within 12 months of donation, was distributed.",4/3/2007,"04/03/2007",5/29/2013,"05/29/2013"
"Biologics",39052,"Terminated","Northwest Florida Blood Center, Inc.","Pensacola","FL","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Florida","B-1251-13","Class II","Red Blood Cells Leukocytes Reduced","5212449",".","1 unit","Blood products, which quality control and distribution/required testing not performed were distributed. ",3/22/2007,"03/22/2007",5/29/2013,"05/29/2013"
"Biologics",39052,"Terminated","Northwest Florida Blood Center, Inc.","Pensacola","FL","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Florida","B-1250-13","Class II","Fresh Frozen Plasma","5212449",".","1 unit","Blood products, which quality control and distribution/required testing not performed were distributed. ",3/22/2007,"03/22/2007",5/29/2013,"05/29/2013"
"Biologics",39053,"Terminated","Florida Georgia Blood Alliance, Inc.","Jacksonville","FL","US","Voluntary: Firm Initiated","Telephone","FL","B-1093-13","Class II","Red Blood Cells Leukocytes Reduced","8604369",".","1 unit","Blood product, collected from a donor in which donor suitability was not adequately determined, was distributed.",6/19/2007,"06/19/2007",5/29/2013,"05/29/2013"
"Biologics",39071,"Terminated","Community Blood Centers of South Florida, Inc.","Lauderhill","FL","US","Voluntary: Firm Initiated","Telephone","Florida","B-1368-13","Class III","Red Blood Cells (Apheresis)","2302264(Part A), 2302264(Part B)",,"2 units","Blood products, for which RBC volume QC. failed, were distributed.",5/15/2007,"05/15/2007",7/31/2013,"07/31/2013"
"Biologics",39075,"Terminated","Community Blood Centers of South Florida, Inc.","Lauderhill","FL","US","Voluntary: Firm Initiated","Telephone","Florida","B-1321-13","Class II","Platelets Pheresis Leukocytes Reduced","2432047",".","2","Blood products, labeled leukoreduced which did not meet the requirements for leukoreduced products, were distributed.",6/10/2007,"06/10/2007",6/5/2013,"06/05/2013"
"Biologics",39077,"Terminated","Community Blood Centers of South Florida, Inc.","Lauderhill","FL","US","Voluntary: Firm Initiated","Telephone","Florida","B-1327-13","Class II","Platelets Leukocytes Reduced","2432106 (split product)",".","3","Blood products, which did not meet the specified pH for platelets, were distributed. ",6/15/2007,"06/15/2007",6/5/2013,"06/05/2013"
"Biologics",39097,"Terminated","Blood Center of Central Iowa (The)","Des Moines","IA","US","Voluntary: Firm Initiated","Telephone","IA","B-0778-13","Class III","Red Blood Cells Leukocytes Reduced","LX63739",".","1 unit","Blood product, which was labeled with an incorrect expiration date, was distributed.",4/23/2007,"04/23/2007",3/27/2013,"03/27/2013"
"Biologics",39098,"Terminated","Blood Center of Central Iowa (The)","Des Moines","IA","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","IA, CSL (fractionator)","B-0867-13","Class II","Red Blood Cells","FM50697",,"1 unit","Blood products, collected from a donor taking the Prednisone, were distributed.",6/9/2007,"06/09/2007",4/3/2013,"04/03/2013"
"Biologics",39099,"Terminated","Blood Center of Central Iowa (The)","Des Moines","IA","US","Voluntary: Firm Initiated","Other","IL, IA","B-0864-13","Class II","Blood and Blood Products for Reprocessing","KW65638",,"1 unit","Blood products, collected from a donor considered to be at increased risk for variant Creutzfeldt-Jakob Disease (vCJD), were distributed.",6/12/2007,"06/12/2007",4/3/2013,"04/03/2013"
"Biologics",39101,"Terminated","Blood Center of Central Iowa (The)","Des Moines","IA","US","Voluntary: Firm Initiated","Telephone","IA","B-0927-13","Class III","Platelets Pheresis Leukocytes Reduced Irradiated","P39893",".","1 unit","Blood product, which may have been exposed to unacceptable temperatures during storage, was distributed.",6/26/2007,"06/26/2007",4/10/2013,"04/10/2013"
"Biologics",39102,"Terminated","Blood Center of Central Iowa (The)","Des Moines","IA","US","Voluntary: Firm Initiated","Letter","IA","B-0928-13","Class II","Red Blood Cells","KX17959",".","1 unit","Blood product, which were collected from a donor who traveled to malarial endemic areas, was distributed. ",7/11/2007,"07/11/2007",4/24/2013,"04/24/2013"
"Biologics",39104,"Terminated","Mississippi Valley Reg Bld Ctr","Davenport","IA","US","Voluntary: Firm Initiated","FAX","PA, IL, Switzerland","B-0315-13","Class II","Cryoprecipitated AHF","J65110",".","1 unit","Blood products, collected from a donor who was at risk for variant Creutzfeldt-Jakob Disease (vCJD), were distributed.",4/20/2007,"04/20/2007",2/27/2013,"02/27/2013"
"Biologics",39104,"Terminated","Mississippi Valley Reg Bld Ctr","Davenport","IA","US","Voluntary: Firm Initiated","FAX","PA, IL, Switzerland","B-0317-13","Class II","Recovered Plasma","J65110",".","1 unit","Blood products, collected from a donor who was at risk for variant Creutzfeldt-Jakob Disease (vCJD), were distributed.",4/20/2007,"04/20/2007",2/27/2013,"02/27/2013"
"Biologics",39104,"Terminated","Mississippi Valley Reg Bld Ctr","Davenport","IA","US","Voluntary: Firm Initiated","FAX","PA, IL, Switzerland","B-0316-13","Class II","Fresh Frozen Plasma","J62864",".","1 unit","Blood products, collected from a donor who was at risk for variant Creutzfeldt-Jakob Disease (vCJD), were distributed.",4/20/2007,"04/20/2007",2/27/2013,"02/27/2013"
"Biologics",39106,"Terminated","Mississippi Valley Reg Bld Ctr","Davenport","IA","US","Voluntary: Firm Initiated","Telephone","Iowa; Illinois","B-0344-13","Class II","Platelets Pheresis Leukocytes Reduced","K42721;K42646",".","2 Units","Blood products, for which the quality control testing was incomplete, were distributed.",4/2/2007,"04/02/2007",1/9/2013,"01/09/2013"
"Biologics",39106,"Terminated","Mississippi Valley Reg Bld Ctr","Davenport","IA","US","Voluntary: Firm Initiated","Telephone","Iowa; Illinois","B-0343-13","Class II","Platelets Pheresis Leukocytes Reduced Irradiated","K42637",".","1 Unit","Blood products, for which the quality control testing was incomplete, were distributed.",4/2/2007,"04/02/2007",1/9/2013,"01/09/2013"
"Biologics",39108,"Terminated","Mississippi Valley Reg Bld Ctr","Davenport","IA","US","Voluntary: Firm Initiated","Letter","Missouri","B-0486-13","Class II","Platelets Pheresis Leukocytes Reduced Irradiated","KN07457",".","1 Unit","Blood product, collected from a donor who disclosed taking a daily dose of Aspirin , was distributed. ",6/7/2007,"06/07/2007",2/6/2013,"02/06/2013"
"Biologics",39109,"Terminated","Mississippi Valley Reg Bld Ctr","Davenport","IA","US","Voluntary: Firm Initiated","Telephone","Missouri; Iowa; New York","B-0342-13","Class II","Platelets Pheresis Leukocytes Reduced","K43528; K43528; K43528",".","3 ","Blood products, for which the quality control testing was incomplete, were distributed.",5/3/2007,"05/03/2007",1/9/2013,"01/09/2013"
"Biologics",39116,"Terminated","Community Blood Bank of Lancaster County Medical Society","Lincoln","NE","US","Voluntary: Firm Initiated","FAX","NE","B-0268-13","Class II","Red Blood Cells (Apheresis) Leukocytes Reduced","3743751- part 1, 3743751- part 2",".","2 units","Blood products, collected from a donor who received a tattoo within 12 months of donation, were distributed.",4/20/2007,"04/20/2007",1/2/2013,"01/02/2013"
"Biologics",39129,"Terminated","American Red Cross Blood Services","Saint Louis","MO","US","Voluntary: Firm Initiated","FAX","IL","B-0539-13","Class II","Red Blood Cells Leukocytes Reduced","011LQ56363",,"1 unit","Blood product, collected from a donor in whom donor suitability was not adequately determined, was distributed.",5/10/2007,"05/10/2007",3/6/2013,"03/06/2013"
"Biologics",39130,"Terminated","American Red Cross Blood Services","Saint Louis","MO","US","Voluntary: Firm Initiated","FAX","MO, TX, CA","B-0541-13","Class II","Red Blood Cells Leukocytes Reduced","011FS50120",,"1 unit","Blood products, collected from a donor in whom donor suitability was not adequately determined, were distributed.",5/14/2007,"05/14/2007",3/6/2013,"03/06/2013"
"Biologics",39130,"Terminated","American Red Cross Blood Services","Saint Louis","MO","US","Voluntary: Firm Initiated","FAX","MO, TX, CA","B-0540-13","Class II","Cryoprecipitated AHF","011FS50120",,"1 unit","Blood products, collected from a donor in whom donor suitability was not adequately determined, were distributed.",5/14/2007,"05/14/2007",3/6/2013,"03/06/2013"
"Biologics",39130,"Terminated","American Red Cross Blood Services","Saint Louis","MO","US","Voluntary: Firm Initiated","FAX","MO, TX, CA","B-0542-13","Class III","Blood and Blood Products for Reprocessing","011FS50120",,"1 unit","Blood products, collected from a donor in whom donor suitability was not adequately determined, were distributed.",5/14/2007,"05/14/2007",3/6/2013,"03/06/2013"
"Biologics",39134,"Terminated","American Red Cross Blood Services","Omaha","NE","US","Voluntary: Firm Initiated","FAX","Nebraska, Michigan","B-2297-13","Class III","Platelets Pheresis Leukocytes Reduced","09FC13758 (3 units), 09FC13780 (2 units)",,"5 units","Blood products, for which a platelet count was not performed, were distributed.",2/26/2007,"02/26/2007",9/25/2013,"09/25/2013"
"Biologics",39135,"Terminated","American National Red Cross (The)","Omaha","NE","US","Voluntary: Firm Initiated","FAX","MI","B-0769-13","Class II","Platelets Pheresis Leukocytes Reduced","09FC14644; 09FC14644",,"2 units","Blood products, which were collected from a donor who traveled to a malarial endemic area, were distributed.",4/18/2007,"04/18/2007",4/3/2013,"04/03/2013"
"Biologics",39136,"Terminated","American National Red Cross (The)","Omaha","NE","US","Voluntary: Firm Initiated","FAX","PA","B-0171-13","Class II","Red Blood Cells Leukocytes Reduced","09FN91160",".","1 unit","Blood product, collected from a donor who reported travel to a malarial endemic area, was distributed.",6/13/2007,"06/13/2007",1/23/2013,"01/23/2013"
"Biologics",39139,"Terminated","Community Blood Center of the Ozarks","Springfield","MO","US","Voluntary: Firm Initiated","Letter","MO and Austria","B-0926-13","Class III","Blood and Blood Products for Reprocessing","6753448",".","1 Unit","Blood product, which was collected from a donor in which donor suitability was not adequately determined, was distributed.",3/28/2007,"03/28/2007",4/24/2013,"04/24/2013"
"Biologics",39139,"Terminated","Community Blood Center of the Ozarks","Springfield","MO","US","Voluntary: Firm Initiated","Letter","MO and Austria","B-0925-13","Class II","Red Blood Cells Leukocytes Reduced Irradiated","6753448",".","1 Unit","Blood product, which was collected from a donor in which donor suitability was not adequately determined, was distributed.",3/28/2007,"03/28/2007",4/24/2013,"04/24/2013"
"Biologics",39140,"Terminated","Community Blood Center of the Ozarks","Springfield","MO","US","Voluntary: Firm Initiated","Telephone","MO; CO; FL; Austria","B-1333-13","Class II","Plasma Cryoprecipitate Reduced","6737687; 6737690 ",".","2 Units","Blood products, collected in a manner that may have compromised the sterility of the units, were distributed.",4/27/2007,"04/27/2007",6/5/2013,"06/05/2013"
"Biologics",39140,"Terminated","Community Blood Center of the Ozarks","Springfield","MO","US","Voluntary: Firm Initiated","Telephone","MO; CO; FL; Austria","B-1330-13","Class II","Red Blood Cells Leukocytes Reduced","6771844; 6772928; 6772953; 6772954; 6772957; 6772969; 6772984; 6772988; 6772993; 6785513; 6785518; 6785525; 6787661",".","13 Units","Blood products, collected in a manner that may have compromised the sterility of the units, were distributed.",4/27/2007,"04/27/2007",6/5/2013,"06/05/2013"
"Biologics",39140,"Terminated","Community Blood Center of the Ozarks","Springfield","MO","US","Voluntary: Firm Initiated","Telephone","MO; CO; FL; Austria","B-1331-13","Class III","Blood and Blood Products for Reprocessing","3772819; 3778044; 6713590; 6713593; 6713595; 6713597; 6714962; 6725151; 6725153; 6725156; 6725168; 6725170; 6725171; 6725190; 6725192; 6725194; 6725197; 6725200; 6725203; 6725204; 6725206; 6725207; 6725208; 6725209; 6725210; 6725211; 6725218; 6725220; 6725222; 6725225; 6725615; 6725768; 6726419; 6730260; 6731455; 6731539; 6731635; 6737411; 6737416; 6737417; 6737418; 6737419; 6737430; 6737432;6737438; 6737442; 6737445; 6737446; 6737449; 6737451; 6737453; 6737454; 6737455; 6737456; 6737460; 737461; 6737465; 6737470; 6737477; 6737478; 6737479; 6737480; 737481; 6737484; 6737484; 6737485; 6737486; 6737499; 6737500; 6737501; 6737503; 6737504; 6737507; 6737508; 6737509; 6737512; 6737516; 6737518; 6737519; 6737520; 6737525; 6737530; 6737531; 6737533; 6737534; 6737535; 6737537; 6737541; 6737542; 6737545; 6737547; 6737550; 6737555; 6737556; 6737558; 6737559; 6737561; 6737563; 6737572; 6737573; 6737575; 6737577; 6737578; 6737581; 6737585; 6737586; 6737591; 6737592; 6737607; 6737609; 6737610; 6737613; 6737615; 6737626; 6737636; 6737641; 6737644; 6737647; 6737649; 6737652; 6737653; 6737657; 6737661; 6737663; 6737670; 6737674; 6737678; 6737680; 6737693; 6737709; 6737713; 6737727; 6737733; 6737734; 6738931; 6738974; 6738981; 6738983; 6739032; 6742616; 6742633; 6744553; 6745834; 6745895; 6746018; 6746021; 6746028; 6746069; 6746070; 6746119; 6746123; 6746475; 6746482; 6746498; 6747375; 6747376; 6747377; 6747378; 6747384; 6750700; 6750702; 6751276; 6751294; 6751305; 6751315; 6751329; 6751331; 6753648; 6753654; 6753671; 6753681; 6755189; 6755196; 6757571; 6757619; 6757626; 6757631; 6757650; 6757683; 6758562; 6758566; 6758567; 6758570; 6758574; 6760288; 6760292; 6760300; 6760310; 6760318; 6760322; 6760332; 6761069; 6761082; 6761086; 6761089; 6761097; 6761120; 6761121; 6761124; 6761133; 6761146; 6761148; 6771148; 6771178;6771179; 6771186; 6771191; 6771205; 6771225; 6771285; 6771303; 6771310; 6771852; 6772750; 6772751; 6772755; 6772756; 6772759; 6772759; 6772762; 6772768; 6772771; 6772774; 6772776; 6772779; 6772782; 6772782; 6",".","301 Units","Blood products, collected in a manner that may have compromised the sterility of the units, were distributed.",4/27/2007,"04/27/2007",6/5/2013,"06/05/2013"
"Biologics",39140,"Terminated","Community Blood Center of the Ozarks","Springfield","MO","US","Voluntary: Firm Initiated","Telephone","MO; CO; FL; Austria","B-1335-13","Class II","Fresh Frozen Plasma","6731455; 6771161; 6772928; 6772931 ",".","4 Units","Blood products, collected in a manner that may have compromised the sterility of the units, were distributed.",4/27/2007,"04/27/2007",6/5/2013,"06/05/2013"
"Biologics",39140,"Terminated","Community Blood Center of the Ozarks","Springfield","MO","US","Voluntary: Firm Initiated","Telephone","MO; CO; FL; Austria","B-1334-13","Class II","Platelets","6787684; 6787747; 6787750 ",".","3 Units","Blood products, collected in a manner that may have compromised the sterility of the units, were distributed.",4/27/2007,"04/27/2007",6/5/2013,"06/05/2013"
"Biologics",39140,"Terminated","Community Blood Center of the Ozarks","Springfield","MO","US","Voluntary: Firm Initiated","Telephone","MO; CO; FL; Austria","B-1332-13","Class II","Cryoprecipitated AHF","6713590; 6721055; 6725204; 6725206;6725207; 6725208; 6725209; 6725210; 6725211; 6725218; 6725220; 6725222; 6725225; 6725768; 6737670; 6737689; 6737732",".","17 Units","Blood products, collected in a manner that may have compromised the sterility of the units, were distributed.",4/27/2007,"04/27/2007",6/5/2013,"06/05/2013"
"Biologics",39140,"Terminated","Community Blood Center of the Ozarks","Springfield","MO","US","Voluntary: Firm Initiated","Telephone","MO; CO; FL; Austria","B-1329-13","Class II","Red Blood Cells","6772914; 6772936; 6772968; 6772994; 6777568; 6782640; 6782660; 6787452; 6787455; 6787484; 6787677; 6787684; 6787704; 6787750; 6792487; 6792517; 6792529; 6792541; 6792543; 6792566; 6792572; 6792580; 6792596; 6792616 ",".","24 Units","Blood products, collected in a manner that may have compromised the sterility of the units, were distributed.",4/27/2007,"04/27/2007",6/5/2013,"06/05/2013"
"Biologics",39143,"Terminated","Community Blood Center of the Ozarks","Springfield","MO","US","Voluntary: Firm Initiated","Letter","CO","B-0932-13","Class II","Fresh Frozen Plasma","6771264",".","1 Unit","Blood product, collected from a donor who was at risk for variant Creutzfeldt-Jakob disease (vCJD), was distributed.",6/21/2007,"06/21/2007",4/10/2013,"04/10/2013"
"Biologics",39149,"Terminated","Blood Systems, Inc.","Scottsdale","AZ","US","Voluntary: Firm Initiated","Telephone","Arizona","B-2062-13","Class II","Platelets Pheresis Leukocytes Reduced","103081478",".","1 unit","Blood product, with positive bacterial detection testing, was distributed.",5/9/2007,"05/09/2007",8/28/2013,"08/28/2013"
"Biologics",39150,"Terminated","Blood Systems, Inc.","Scottsdale","AZ","US","Voluntary: Firm Initiated","Telephone","Arizona","B-2063-13","Class II","Platelets Pheresis Leukocytes Reduced Irradiated","103697958",".","1 unit","Blood product, with positive bacterial detection testing, was distributed.",5/9/2007,"05/09/2007",8/28/2013,"08/28/2013"
"Biologics",39151,"Terminated","Blood Systems, Inc.","Scottsdale","AZ","US","Voluntary: Firm Initiated","Telephone","Arizona","B-2064-13","Class II","Platelets Pheresis Leukocytes Reduced","108021563(Part A); 108021563(Part B)",".","2 units","Blood Products, which were contaminated with Corynebacterium species, were distributed. ",5/13/2008,"05/13/2008",8/28/2013,"08/28/2013"
"Biologics",39152,"Terminated","Blood Systems, Inc.","Scottsdale","AZ","US","Voluntary: Firm Initiated","Telephone","Arizona","B-2339-13","Class III","Red Blood Cells (Apheresis) Leukocytes Reduced","103692448(Part A) ;103692448(Part B)",".","2 units","Blood products, which failed to meet the minimum specification for percent red blood cell recovery, were distributed.",6/19/2007,"06/19/2007",9/18/2013,"09/18/2013"
"Biologics",39155,"Terminated","Blood Systems, Inc.","Scottsdale","AZ","US","Voluntary: Firm Initiated","Letter","Arizona","B-2050-13","Class II","Red Blood Cells Leukocytes Reduced","108012740(Part A)",".","1 unit","Blood products, which were collected from a donor who traveled to a malarial endemic area, were distributed. ",7/10/2007,"07/10/2007",8/28/2013,"08/28/2013"
"Biologics",39156,"Terminated","Blood Systems, Inc.","Scottsdale","AZ","US","Voluntary: Firm Initiated","Letter","Arizona","B-2051-13","Class II","Red Blood Cells Leukocytes Reduced","108024925(Part A)",".","1 unit","Blood products, which were collected from a donor who traveled to a malarial endemic area, were distributed. ",8/7/2007,"08/07/2007",8/28/2013,"08/28/2013"
"Biologics",39163,"Terminated","American National Red Cross (The)","Pomona","CA","US","Voluntary: Firm Initiated","Letter","California","B-0026-14","Class III","Red Blood Cells Leukocytes Reduced","07GQ20577, 07GQ20578",".","2 units","Blood products, collected using scales for which the quality control testing was performed incorrectly, were distributed.",8/16/2007,"08/16/2007",12/4/2013,"12/04/2013"
"Biologics",39169,"Terminated","American National Red Cross (The)","Tucson","AZ","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Arizona","B-1709-13","Class II","Red Blood Cells Leukocytes Reduced","007FN52555",".","1","Blood product, collected from a donor who traveled to a malaria endemic area, was distributed.",2/14/2007,"02/14/2007",7/17/2013,"07/17/2013"
"Biologics",39170,"Terminated","American National Red Cross (The)","Tucson","AZ","US","Voluntary: Firm Initiated","Telephone","AZ","B-1708-13","Class III","Red Blood Cells (Apheresis) Leukocytes Reduced","007GG15294 Part 1;007GG15294 Part 2",".","2","Blood products, in which extra amount of red cell preservative solution was added, were distributed.",3/29/2007,"03/29/2007",7/17/2013,"07/17/2013"
"Biologics",39171,"Terminated","American National Red Cross (The)","Tucson","AZ","US","Voluntary: Firm Initiated","Telephone","AZ","B-2466-13","Class II","Red Blood Cells Leukocytes Reduced","007GF08682, 007GF08684, 007GF08679, 007GF08683, 007GF08685, 007GF08686, 007GF08691, 007GF08700, 007GF08702, 007GF08687, 007GF08688, 007GF08694, 007GF08695, 007GF08701, 007GF08699, 007GF08689, 007GF08697",,"17 units","Blood products, collected from donors whose hemoglobin determination was performed using expired microcuvettes, were distributed.",4/17/2007,"04/17/2007",11/6/2013,"11/06/2013"
"Biologics",39172,"Terminated","American National Red Cross (The)","Tucson","AZ","US","Voluntary: Firm Initiated","Letter","AZ","B-2495-13","Class III","Red Blood Cells Leukocytes Reduced","007FE44669, 007FE44667, 007FE44666, 007FE44663, 007FE44662, 007FE44661, 007FE44660, 007FE44659, 007FE44657, 007FE44656",,"10 units","Blood products, collected using scales for which the quality control results were not documented, were distributed.",7/2/2007,"07/02/2007",11/6/2013,"11/06/2013"
"Biologics",39173,"Terminated","American National Red Cross (The)","Tucson","AZ","US","Voluntary: Firm Initiated","Letter","AZ","B-2498-13","Class III"," Red Blood Cells (Apheresis) Leukocytes Reduced, Irradiated ","FT03086; FT02664; FT02845; FT03023; FT03763; FT04221; FT04217; FT16827; FT17393; FT17394; FM11041; FT17422; FT17439 ",,"13 units","Blood products, not prepared in accordance with specifications, were distributed. ",6/15/2007,"06/15/2007",11/27/2013,"11/27/2013"
"Biologics",39173,"Terminated","American National Red Cross (The)","Tucson","AZ","US","Voluntary: Firm Initiated","Letter","AZ","B-2497-13","Class III","Red Blood Cells (Apheresis) Leukocytes Reduced ","FT02001; FT02010; FT02003; FT02014; FT02013; FT02004; FT02005; FT02012; FT02015; FT02016; FT02017; FT02018; FT02020; FT02022 FT02009; FT02011; FT02025; FT02026; FT02028; FT02030; FT02034 FT02033; FT02035; FT02037; FT02038; FT02039; FT02040; FT02041 FT02043; FT02044; FT02048; FT02050; FT02049; FT02052; FT02068 FT02066; FT02058; FT02060; FT02062; FT02064; FT02070; FT02071 FT02072; FT02075; FT02082; FT02088; FT02094; FT02076; FT02099 FT02097; FT02105; FT02107; FT02108; FT02111; FT02127; FT02134 FT02155; FT02153; FT02166; FT02167; FT02148; FT02188; FT02182 FT02198; FT02200; FT02209; FT02211; FT02217; FT02204; FT02228 FT02218; FT02219; FT02221; FT02222; FT02234; FT02239; FT02248 FT02257; FT02267; FT02275; FT02276; FT02278; FT02279; FT02292 FT02294; FT02299; FT02271; FT02317; FT02324; FT02329; FT02343 FT02347; FT02332; FT02352; FT02359; FT02365; FT02379; FT02384 FT02384; FT02386; FT02389; FT02398; FT02434; FT02427; FT02432 FT02423; FT02445; FT02467; FT02489; FT02480; FT02504; FT02493 FT02498; FT02500; FT02497; FT02514; FT02510; FT02518; FT02526 FT02521; FT02540; FT02523; FT02634; FT02622; FT02629; FT02641 FT02649; FT02691; FT02667; FT02664; FT02658; FT02668; FT02693 FT02723; FT02729; FT02734; FT02713; FT02711; FT02774; FT02759 FT02845; FT02850; FT02839; FT02853; FT02861; FT02866; FT02889 FT02921; FT02924; FT02941; FT02945; FT02928; FT02960; FT02968 FT02972; FT03023; FT02979; FT03029; FT03035; FT03042; FT03071 FT03067; FT03086; FT03114; FT03118; FT02727; FT03140; FT03145 FT03154; FT03230; FT03227; FT03228; FT03331; FT03357; FT03364 FT03367; FT03374; FT03385; FT03386; FT03401; FT03402; FT03412 FT03435; FT03445; FT03496; FT03551; FT03553; FT03546; FT03539 FT03543; FT03612; FT03620; FT03622; FT03631; FT03646; FT03638 FT03639; FT03637; FT03674; FT03692; FT03715; FT03696; FT03678 FT03726; FT03745; FT03747; FT03763; FT03772; FT03787; FT03801 FT03802; FT03832; FT03830; FT03849; FT03876; FT03894; FT03923 FT03921; FT03936; FT03965; FT04012; FT04009; FT03991; FT04021 FT04020; FT04035; FT04102; FT04123; FT04172; FT04173; FT0415",,"1031 units","Blood products, not prepared in accordance with specifications, were distributed. ",6/15/2007,"06/15/2007",11/27/2013,"11/27/2013"
"Biologics",39174,"Terminated","Community Blood Bank, Inc.","Rancho Mirage","CA","US","Voluntary: Firm Initiated","Letter","California","B-2318-13","Class III","Red Blood Cells Leukocytes Reduced","0623626",,"1 unit","Blood products, prepared without additive (Optisol), were distributed. ",7/11/2007,"07/11/2007",9/25/2013,"09/25/2013"
"Biologics",39175,"Terminated","Southern California Permanente Medical Group Blood Donor Center","Irvine","CA","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","CA","B-1681-13","Class III","Plasma Frozen","KK15215; KK15186; KK13926; KK13907; KK13906; KK13867; KK13868; KJ42191; KK13869",".","9 units","Blood products, collected from a donor in which donor suitability was not adequately determined, were distributed.",4/4/2007,"04/04/2007",7/17/2013,"07/17/2013"
"Biologics",39175,"Terminated","Southern California Permanente Medical Group Blood Donor Center","Irvine","CA","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","CA","B-1680-13","Class III","Red Blood Cells","KK15215; KK15213; KK15186",".","3 units","Blood products, collected from a donor in which donor suitability was not adequately determined, were distributed.",4/4/2007,"04/04/2007",7/17/2013,"07/17/2013"
"Biologics",39177,"Terminated","Blood Bank of San Bernardino and Riverside Counties","San Bernardino","CA","US","Voluntary: Firm Initiated","Letter","California","B-1789-13","Class II","Red Blood Cells","GP92319",,"1 unit","Blood product, possibly contaminated with air, was distributed.",5/7/2007,"05/07/2007",7/31/2013,"07/31/2013"
"Biologics",39179,"Terminated","San Diego Blood Bank","San Diego","CA","US","Voluntary: Firm Initiated","Letter","CA","B-2096-13","Class III","Red Blood Cells Leukocytes Reduced","H78161; H78059; H78063; H78066; H79860; H79870; H78113; H79788; H79790; H79791; H79795; H78108; H78060; H79898; H79905",,"15 units","Blood products, manufactured with an extended time outside of refrigeration, were distributed.",3/17/2007,"03/17/2007",8/21/2013,"08/21/2013"
"Biologics",39187,"Terminated","Octapharma Plasma Inc","San Diego","CA","US","Voluntary: Firm Initiated","Letter","IL, Switzerland","B-0027-14","Class II","Source Plasma","0460004858, 0460004635, 0460002270, YA190229, YA190136, YA189991, YA189818, YA189516, YA189428, YP221933, YP221853, YP221708, YP221571, YP221411, YP221316, YP221195, YT115612, YT115410, YT115364, YT115279, YT115179, YT115115, YT114852, YT114706, YT114680, YT114576, YT114541, YT114440, YT114429, YT114324, YT114289, YT115037, YT114985",".","33 units","Blood products, which tested negative for viral markers, but were collected from a donor who previously tested positive for the antibody to hepatitis C virus (anti-HCV), were distributed.",5/25/2007,"05/25/2007",12/4/2013,"12/04/2013"
"Biologics",39188,"Terminated","Children's Hospital of Orange County: Blood & Donor Services","Orange","CA","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","CA","B-1312-13","Class II","Platelets Pheresis Leukocytes Reduced","FE18334,PART1; FE18334,PART2",".","2 units","Blood products, which were collected from a donor who had taken aspirin prior to the donation, were distributed.",7/26/2001,"07/26/2001",5/29/2013,"05/29/2013"
"Biologics",39189,"Terminated","Talecris Plasma Resources Inc Dba International Bioresources","Research Triangle Park","NC","US","Voluntary: Firm Initiated","FAX","North Carolina","B-1721-13","Class II","Source Plasma","368038850",,"1","Blood products, collected from a donor whose annual physical exam was not performed, were distributed.",4/19/2007,"04/19/2007",7/3/2013,"07/03/2013"
"Biologics",39191,"Terminated","Southern California Permanente Medical Group Blood Bank","San Diego","CA","US","Voluntary: Firm Initiated","E-Mail","CA","B-1783-13","Class II","Fresh Frozen Plasma","FJ62759",".","1 unit","Blood products, collected from a donor who was at risk for variant Creutzfeldt-Jakob disease (vCJD), were distributed. ",5/22/2007,"05/22/2007",7/17/2013,"07/17/2013"
"Biologics",39191,"Terminated","Southern California Permanente Medical Group Blood Bank","San Diego","CA","US","Voluntary: Firm Initiated","E-Mail","CA","B-1782-13","Class II","Red Blood Cells","FJ62759",".","1 unit","Blood products, collected from a donor who was at risk for variant Creutzfeldt-Jakob disease (vCJD), were distributed. ",5/22/2007,"05/22/2007",7/17/2013,"07/17/2013"
"Biologics",39192,"Terminated","HemaCare Corporation","Van Nuys","CA","US","Voluntary: Firm Initiated","Letter","CA","B-2564-13","Class III","Fresh Frozen Plasma","6158519",,"1 unit","Blood product, prepared from a whole blood unit that had an extended bleed time documented, was distributed.",10/4/2006,"10/04/2006",11/27/2013,"11/27/2013"
"Biologics",39198,"Terminated","HemaCare Corporation","Van Nuys","CA","US","Voluntary: Firm Initiated","Letter","CA","B-2187-13","Class II","Red Blood Cells Leukocytes Reduced","4023161",".","1 unit","Blood products, which were collected from a donor in which donor suitability was not adequately determined, were distributed.",1/30/2006,"01/30/2006",9/18/2013,"09/18/2013"
"Biologics",39198,"Terminated","HemaCare Corporation","Van Nuys","CA","US","Voluntary: Firm Initiated","Letter","CA","B-2186-13","Class II","Fresh Frozen Plasma","4023161",".","1 unit","Blood products, which were collected from a donor in which donor suitability was not adequately determined, were distributed.",1/30/2006,"01/30/2006",9/18/2013,"09/18/2013"
"Biologics",39199,"Terminated","BioLife Plasma Services L.P.","Van Nuys","CA","US","Voluntary: Firm Initiated","Telephone","California","B-1932-13","Class II","Source Plasma"," 5497515,5493852 ,5490646 ,5435494 ,03ATXD8952 , 03ATXD8350 ,030WID5154 ,03ATXD7245 ,030WID4563 , 03ATXD6718 ,92426047 ,03ATXD3475 ,03ATXD2073 , 81844791 ,90023088 ,82899691 ,95029559 ,85507142 , 82896096 ,85505056 ,85500884 ,85498747 ,85486683 , 85485266 ,85481107 ,85479753 ,03HWVA3474 ,03HWVA3195 , 03HWVA2891 ,86233026 ,91312808 ,86228411 ,82430757 , 84098917 ,82429966 ,03PWVA2307 ,03TOHA2187 , 86219440 ,86220002 ,82426606 ,82425036 ,82420130 , 03DOHA1086 ,92648463 ,03TOHA1911 ,86214001 , 03PWVA1959 ,03GNCA2128 ,03DOHA0820 ,92645622 , 03TOHA1495 ,86204644 ,03GNCA1686 ,84087836 , 03TOHA1246 ,92406469 ,86199322 ,03DOHA0556 , 03DOHA0550 ,92641945 ,03TOHA0874 ,03RMIA0654 , 03DOHA0316 ,86186377 ,03DOHA0140 ,03TOHA0491 , 03RMIA0283 ,86177009 ,03RMIA0029 ,03TOHA0119 , 86175647 ,86166454 ,86165099 ,80447573D ,78336018 , 83706882D ,86155540 ,85432956D ,80442387 ,78333659 , 83703348D ,86150835 ,02DOHA3331 ,80438250D , 78331532 ,02DOHA3186 ,86141208 ,80433217D , 78440258D ,86136051D ,02LKYB2845 ,02LKYB2784 , 84811394D ,84811417D ,78438170T ,02DIAD2181 , 02RVAB6902 ,78436657T ,84805331D ,84805355D , 02LKYB2562 ,02GMIG0005 ,02MWII0872 ,02RVAB6689 , 02LKYB2536 ,02MWII0572 ,02RVAB6486 ,84795588D , 84792952D ,84789907 ,84788535D ,91056498 , 02RVAB6064 ,85408876D ,70551013D ,02LKYB1703 , 02LKYB1587 ,80392118D ,02FNDH0949 ,02HHIC0478 , 02HHIC0177 ,02LKYB1337 ,02HHIC0044 ,020NEA2959 , 020NEA2931 ,02BVAA6836 ,02HHIB9703 ,02BVAA6692 , 020NEA2804 ,68262181D ,68262754D ,91269874 , 020NEA2697 ,71336855D ,68262167D ,02BVAA6395 , 91227164 ,68260965D ,68260293D ,020NEA2582 , 68259877D ,83308802D ,71334868D ,68259303D , 020NEA2586 ,02BVAA6300 ,68257927D ,83307744D , 77683762D ,77684066D ,68258269 ,77682123D , 1330631D ,02BVAA6027 ,71328522D ,68253257D , 02BVAA5920 ,77690296D ,66915546 ,91007322 , 71323985D ,02BVAA5695 ,90436505D ,020NEA2729 , 02BVAA5468 ,02BVAA5367 ,90432507D ,81078882D , 02BVAA5240 ,90200380 ,81073832D ,67978755D , 66903741 ,02BVAA5104 ,67977055D ,02BVAA5019 , 02BVAA4969 ,81064",,"269 units","Blood products, which were not quarantined subsequent to receiving information regarding a post donation information related to vCJD risk, were distributed.",6/18/2007,"06/18/2007",7/31/2013,"07/31/2013"
"Biologics",39200,"Terminated","BioLife Plasma Services L.P.","Van Nuys","CA","US","Voluntary: Firm Initiated","E-Mail","California","B-1919-13","Class II","Source Plasma","07RMIB5916",".","1","Blood product, collected from a donor who reported post donation information regarding IV drug use, was distributed.",8/16/2007,"08/16/2007",8/14/2013,"08/14/2013"
"Biologics",39432,"Terminated","LifeSouth Community Blood Centers, Inc.","Dunwoody","GA","US","Voluntary: Firm Initiated","Other","GA","B-1065-13","Class III","Platelets Pheresis Leukocytes Reduced","71X077426",".","1 unit","Blood product, for which the quality control testing was incomplete, was distributed.",10/25/2004,"10/25/2004",5/29/2013,"05/29/2013"
"Biologics",39434,"Terminated","Life Sera, Inc.","Clarkston","GA","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Germany","B-1169-13","Class II","Source Plasma","FT01233251; FT01233373; FT01233495; FT01233601",".","4 units","Blood products, which tested negative for the human immunodeficiency virus (HIV) but were collected from a donor who previously tested positive for HIV, were distributed.",12/29/2004,"12/29/2004",5/29/2013,"05/29/2013"
"Biologics",39441,"Terminated","Northwest Florida Blood Center, Inc.","Pensacola","FL","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Florida, Switzerland","B-1240-13","Class III","Blood and Blood Products for Reprocessing","4050499",".","1 unit","Blood products, collected from a donor who was at risk for variant Creutzfeldt-Jakob disease (vCJD), were distributed.",8/5/2004,"08/05/2004",5/29/2013,"05/29/2013"
"Biologics",39441,"Terminated","Northwest Florida Blood Center, Inc.","Pensacola","FL","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Florida, Switzerland","B-1239-13","Class II","Red Blood Cells Leukocytes Reduced","4050499",".","1 unit","Blood products, collected from a donor who was at risk for variant Creutzfeldt-Jakob disease (vCJD), were distributed.",8/5/2004,"08/05/2004",5/29/2013,"05/29/2013"
"Biologics",39441,"Terminated","Northwest Florida Blood Center, Inc.","Pensacola","FL","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Florida, Switzerland","B-1238-13","Class II","Platelets","4050499",".","1 unit","Blood products, collected from a donor who was at risk for variant Creutzfeldt-Jakob disease (vCJD), were distributed.",8/5/2004,"08/05/2004",5/29/2013,"05/29/2013"
"Biologics",39454,"Terminated","American National Red Cross (The)","Boise","ID","US","Voluntary: Firm Initiated","FAX","Idaho.","B-0791-13","Class II","Fresh Frozen Plasma (Apheresis)","20LR16622",".","1 component","Blood products, collected from a donor whose arm scrub procedure was performed incorrectly, were distributed.",11/30/2004,"11/30/2004",3/27/2013,"03/27/2013"
"Biologics",39454,"Terminated","American National Red Cross (The)","Boise","ID","US","Voluntary: Firm Initiated","FAX","Idaho.","B-0790-13","Class II","Platelets Pheresis Leukocytes Reduced","20LR16622",".","1 component","Blood products, collected from a donor whose arm scrub procedure was performed incorrectly, were distributed.",11/30/2004,"11/30/2004",3/27/2013,"03/27/2013"
"Biologics",39461,"Terminated","American National Red Cross (The)","Salt Lake City","UT","US","Voluntary: Firm Initiated","Telephone","Washington, Oregon, Utah, California, and Idaho.","B-0787-13","Class II","Red Blood Cells Leukocytes Reduced","020LN57617 , 020LN57588 , 020LN57632 , 020LN57626 , 020LN57591 , 020LN57638 , 020LN57584 , 020LY55252 , 020LC71725 , 020LC71693 , 020LY55273 , 020LY55260 , 020LY55275 , 020LY55254 , 020LN57623 , 020LY55256 , 020LZ26853 , 020LZ26857 , 020LZ26850 , 020LC71703 , 020LZ26855 , 020LY55263 , 020LY55258 , 020LY55257 , 020LY55255 , 020LZ26861 , 020LZ26864 , 020LZ26869 , 020LY55261 , 020LN57596.",".","30 components","Blood products, which were collected from donors in which donor suitability was not adequately determined, were distributed.",12/1/2004,"12/01/2004",3/27/2013,"03/27/2013"
"Biologics",39461,"Terminated","American National Red Cross (The)","Salt Lake City","UT","US","Voluntary: Firm Initiated","Telephone","Washington, Oregon, Utah, California, and Idaho.","B-0788-13","Class II","Fresh Frozen Plasma","020LY55252.",".","1 component","Blood products, which were collected from donors in which donor suitability was not adequately determined, were distributed.",12/1/2004,"12/01/2004",3/27/2013,"03/27/2013"
"Biologics",39461,"Terminated","American National Red Cross (The)","Salt Lake City","UT","US","Voluntary: Firm Initiated","Telephone","Washington, Oregon, Utah, California, and Idaho.","B-0789-13","Class II","Fresh Frozen Plasma","020LN57613, 020LN57641, 020LN57605.",".","3 components","Blood products, which were collected from donors in which donor suitability was not adequately determined, were distributed.",12/1/2004,"12/01/2004",3/27/2013,"03/27/2013"
"Biologics",39463,"Terminated","American Red Cross Blood Services","Omaha","NE","US","Voluntary: Firm Initiated","Letter","Nebraska; Ohio; Pennsylvania; New Jersey; Switzerland","B-2259-13","Class II","Red Blood Cells Leukocytes Reduced","09FF37204; 09V58759; 09V78804; 09V96002",,"4 Units","Blood products, which were collected from a donor who traveled to a malarial endemic area, were distributed.",11/30/2004,"11/30/2004",9/25/2013,"09/25/2013"
"Biologics",39504,"Terminated","American Red Cross Blood Services","Omaha","NE","US","Voluntary: Firm Initiated","Letter","Nebraska; Pennsylvania;California","B-1097-13","Class II","Red Blood Cells Leukocytes Reduced","09GV13749; 09GV14552; 09GV15492",".","3 Units","Blood products, which were collected from a donor who traveled to a malarial endemic area, were distributed.",12/10/2004,"12/10/2004",5/15/2013,"05/15/2013"
"Biologics",39520,"Terminated","LifeServe Blood Center","Des Moines","IA","US","Voluntary: Firm Initiated","Letter","New Jersey","B-0748-13","Class III","Red Blood Cells (Apheresis) Leukocytes Reduced","H15057",,"1 Unit","Blood product, which failed to meet the minimum specification for 85% red blood cell recovery, was distributed.",1/24/2005,"01/24/2005",4/3/2013,"04/03/2013"
"Biologics",39521,"Terminated","LifeServe Blood Center","Des Moines","IA","US","Voluntary: Firm Initiated","Letter","Iowa","B-0749-13","Class III","Red Blood Cells (Apheresis) Leukocytes Reduced","H15054",,"1 Unit","Blood product, which failed to meet the minimum specification for 85% red blood cell recovery, was distributed.",1/24/2005,"01/24/2005",4/3/2013,"04/03/2013"
"Biologics",39526,"Terminated","American National Red Cross","Salt Lake City","UT","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Idaho, Montana, and Utah and California","B-0244-13","Class II","Red Blood Cells Leukocytes Reduced","20FC26689; 20J98938; 20LE04227; 20LE04232; 20LY55656",".","5 units","Blood product, which was collected from a donor who traveled to a malarial endemic area, was distributed. ",12/10/2004,"12/10/2004",1/2/2013,"01/02/2013"
"Biologics",39536,"Terminated","Community Blood Centers of South Florida, Inc.","Lauderhill","FL","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Florida","B-1369-13","Class II","Platelets","1699871",".","1 unit","Platelet, with an unacceptable pH, was distributed. ",1/19/2005,"01/19/2005",6/19/2013,"06/19/2013"
"Biologics",39546,"Terminated","Biomat USA, Inc.","Mesa","AZ","US","Voluntary: Firm Initiated","Letter","Spain","B-2344-13","Class III","Source Plasma","0210038593 0210041652 ",".","2 units","Blood products, collected from a donor who was deferred for unknown reasons, were distributed. ",1/3/2005,"01/03/2005",9/18/2013,"09/18/2013"
"Biologics",39567,"Terminated","Northwest Florida Blood Center, Inc.","Pensacola","FL","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Florida","B-1252-13","Class II","Platelets Leukocytes Reduced"," 4727989; 4727982A; 4727982B.",".","3 units","Blood products, which did not meet the acceptable product specifications, were distributed.",1/5/2005,"01/05/2005",6/5/2013,"06/05/2013"
"Biologics",39573,"Terminated","San Diego Blood Bank","San Diego","CA","US","Voluntary: Firm Initiated","Letter","CA","B-1734-13","Class II","Red Blood Cells","KW66248",,"1 unit","Blood product, collected from a donor who traveled to a malarial endemic area, was distributed.",2/4/2005,"02/04/2005",8/21/2013,"08/21/2013"
"Biologics",39575,"Terminated","San Diego Blood Bank","San Diego","CA","US","Voluntary: Firm Initiated","Letter","CA","B-2042-13","Class II","Red Blood Cells","LR07445",,"1 unit","Blood product, collected from a donor who had traveled to a malarial endemic area, was distributed.",1/18/2005,"01/18/2005",8/21/2013,"08/21/2013"
"Biologics",39579,"Terminated","LifeServe Blood Center","Sioux City","IA","US","Voluntary: Firm Initiated","Letter","South Dakota, Austria","B-0407-13","Class II","Blood and Blood Products for Reprocessing","1970058",".","1 unit","Blood products, collected from a donor considered to be at increased risk for variant Creutzfeldt-Jakob Disease (vCJD), were distributed. ",1/7/2005,"01/07/2005",1/23/2013,"01/23/2013"
"Biologics",39579,"Terminated","LifeServe Blood Center","Sioux City","IA","US","Voluntary: Firm Initiated","Letter","South Dakota, Austria","B-0406-13","Class II","Red Blood Cells","1970058",".","1 unit","Blood products, collected from a donor considered to be at increased risk for variant Creutzfeldt-Jakob Disease (vCJD), were distributed. ",1/7/2005,"01/07/2005",1/23/2013,"01/23/2013"
"Biologics",39583,"Terminated","LifeServe Blood Center","Des Moines","IA","US","Voluntary: Firm Initiated","Letter","Illinois","B-0698-13","Class II","Red Blood Cells","LG13666; LG13318",,"2 Units","Blood products, which were collected from a donor who traveled to a malarial endemic area, were distributed.",12/24/2004,"12/24/2004",3/20/2013,"03/20/2013"
"Biologics",39591,"Terminated","Northwest Florida Blood Center, Inc.","Pensacola","FL","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Florida","B-1253-13","Class II","Platelets Pheresis Leukocytes Reduced","4072021A; 4072021B.",".","2 units","Blood products, which were labeled as leukoreduced, but were not tested to verify the White Blood Cell count, were distributed.",10/28/2004,"10/28/2004",6/5/2013,"06/05/2013"
"Biologics",39636,"Terminated","LifeServe Blood Center","Sioux City","IA","US","Voluntary: Firm Initiated","Letter","IA, SD","B-0473-13","Class II","Red Blood Cells (Apheresis) Leukocytes Reduced","1959203;1959203",".","2 units","Blood products, collected from a donor who reported travel to a malarial endemic area, were distributed.",1/13/2005,"01/13/2005",1/23/2013,"01/23/2013"
"Biologics",39637,"Terminated","LifeServe Blood Center","Sioux City","IA","US","Voluntary: Firm Initiated","FAX","IA, MO, FL, VA, Austria","B-0468-13","Class II","Blood and Blood Products for Reprocessing","1879895;1888158;1933200",".","3 units","Blood products, collected from a donor considered to be at increased risk for variant Creutzfeldt-Jakob Disease (vCJD), were distributed. ",1/8/2005,"01/08/2005",2/27/2013,"02/27/2013"
"Biologics",39637,"Terminated","LifeServe Blood Center","Sioux City","IA","US","Voluntary: Firm Initiated","FAX","IA, MO, FL, VA, Austria","B-0466-13","Class II","Red Blood Cells (Apheresis) Leukocytes Reduced","1944382; 1944382",".","2 units","Blood products, collected from a donor considered to be at increased risk for variant Creutzfeldt-Jakob Disease (vCJD), were distributed. ",1/8/2005,"01/08/2005",2/27/2013,"02/27/2013"
"Biologics",39637,"Terminated","LifeServe Blood Center","Sioux City","IA","US","Voluntary: Firm Initiated","FAX","IA, MO, FL, VA, Austria","B-0467-13","Class II","Red Blood Cells Leukocytes Reduced","1879895;1888158;1933200",".","3 units","Blood products, collected from a donor considered to be at increased risk for variant Creutzfeldt-Jakob Disease (vCJD), were distributed. ",1/8/2005,"01/08/2005",2/27/2013,"02/27/2013"
"Biologics",39637,"Terminated","LifeServe Blood Center","Sioux City","IA","US","Voluntary: Firm Initiated","FAX","IA, MO, FL, VA, Austria","B-0465-13","Class II","Cryoprecipitated AHF","1933200",".","1 unit","Blood products, collected from a donor considered to be at increased risk for variant Creutzfeldt-Jakob Disease (vCJD), were distributed. ",1/8/2005,"01/08/2005",2/27/2013,"02/27/2013"
"Biologics",39644,"Terminated","New York Blood Center, Inc.","New York","NY","US","Voluntary: Firm Initiated","Telephone","New Jersey, California, New York, Switzerland","B-0785-13","Class II","Red Blood Cells Irradiated","6238945",".","1","Blood products, collected from donors in which donor suitability was not adequately determined, were distributed.",2/3/2005,"02/03/2005",4/24/2013,"04/24/2013"
"Biologics",39644,"Terminated","New York Blood Center, Inc.","New York","NY","US","Voluntary: Firm Initiated","Telephone","New Jersey, California, New York, Switzerland","B-0781-13","Class II","Red Blood Cells","6238785, 6238816, 6238935, 6238937 and 6238958.",".","5","Blood products, collected from donors in which donor suitability was not adequately determined, were distributed.",2/3/2005,"02/03/2005",4/24/2013,"04/24/2013"
"Biologics",39644,"Terminated","New York Blood Center, Inc.","New York","NY","US","Voluntary: Firm Initiated","Telephone","New Jersey, California, New York, Switzerland","B-0782-13","Class II","Red Blood Cells Leukocytes Reduced","6238820, 6238843, 6238848, 6238859, 6238873, 62388836238900, 6238913,, and 6238918.",".","9","Blood products, collected from donors in which donor suitability was not adequately determined, were distributed.",2/3/2005,"02/03/2005",4/24/2013,"04/24/2013"
"Biologics",39644,"Terminated","New York Blood Center, Inc.","New York","NY","US","Voluntary: Firm Initiated","Telephone","New Jersey, California, New York, Switzerland","B-0784-13","Class II","Fresh Frozen Plasma","6238918, 6238913, 6238900, 6238883, 6238820, 6238816, 6238859, 6238873, 6238848, 6238843.",".","10","Blood products, collected from donors in which donor suitability was not adequately determined, were distributed.",2/3/2005,"02/03/2005",4/24/2013,"04/24/2013"
"Biologics",39644,"Terminated","New York Blood Center, Inc.","New York","NY","US","Voluntary: Firm Initiated","Telephone","New Jersey, California, New York, Switzerland","B-0786-13","Class III","Plasma for Further Manufacturing","6238935, 6238909, 6238785, 6238937,6238945, 6238958",".","6","Blood products, collected from donors in which donor suitability was not adequately determined, were distributed.",2/3/2005,"02/03/2005",4/24/2013,"04/24/2013"
"Biologics",39644,"Terminated","New York Blood Center, Inc.","New York","NY","US","Voluntary: Firm Initiated","Telephone","New Jersey, California, New York, Switzerland","B-0783-13","Class II","Platelets","6238918, 6238913, 6238909, 6238900, 6238820, 6238816, 6238873, 6238848 and 6238843.",".","9","Blood products, collected from donors in which donor suitability was not adequately determined, were distributed.",2/3/2005,"02/03/2005",4/24/2013,"04/24/2013"
"Biologics",39654,"Terminated","American National Red Cross","Salt Lake City","UT","US","Voluntary: Firm Initiated","FAX","UT and CA","B-0892-13","Class III","Red Blood Cells Leukocytes Reduced","020 S75093",".","1 unit","Blood products, collected using expired blood collection sets, were distributed.",1/11/2005,"01/11/2005",5/29/2013,"05/29/2013"
"Biologics",39654,"Terminated","American National Red Cross","Salt Lake City","UT","US","Voluntary: Firm Initiated","FAX","UT and CA","B-0893-13","Class III","Fresh Frozen Plasma","020 S75093",".","1 unit","Blood products, collected using expired blood collection sets, were distributed.",1/11/2005,"01/11/2005",5/29/2013,"05/29/2013"
"Biologics",39660,"Terminated","BioLife Plasma Services L.P.","Lakeland","FL","US","Voluntary: Firm Initiated","FAX","North Carolina","B-1328-13","Class II","Source Plasma","LF240346; LF240044; LF239620; LF239240; LF238990; LF238603; LF238237; LF237823; LF237303; LF237056.",".","10","Blood products, collected from a donor who was permanently deferred after testing reactive for Hepatitis B surface antigen (HbSAg), were distributed.",12/13/2004,"12/13/2004",6/5/2013,"06/05/2013"
"Biologics",39704,"Terminated","Community Blood Centers of South Florida, Inc.","Lauderhill","FL","US","Voluntary: Firm Initiated","FAX","FL","B-1176-13","Class III","Red Blood Cells (Apheresis)","1553291A, 1553291B",".","2 units","Blood products, with an unacceptable hematocrit, were distributed.",2/9/2005,"02/09/2005",5/29/2013,"05/29/2013"
"Biologics",39707,"Terminated","American National Red Cross","Boise","ID","US","Voluntary: Firm Initiated","Telephone","California","B-0916-13","Class II","Red Blood Cells Leukocytes Reduced","20FY02601",".","1 unit","Blood product, collected from a donor, whose screening/donor record was incomplete, was distributed. ",1/21/2005,"01/21/2005",4/24/2013,"04/24/2013"
"Biologics",39714,"Terminated","San Diego Blood Bank","San Diego","CA","US","Voluntary: Firm Initiated","Letter","CA","B-2046-13","Class II","Platelets Pheresis Leukocytes Reduced Irradiated","GH46507- part 1;GH46507- part 2",,"2 units","Blood products, which did not meet the acceptable product specifications for release, were distributed.",3/4/2005,"03/04/2005",8/21/2013,"08/21/2013"
"Biologics",39738,"Terminated","BioLife Plasma Services LP","Springfield","MO","US","Voluntary: Firm Initiated","FAX","CA","B-1450-13","Class II","Source Plasma","04FMOA1901; 04FMOA1730; 04FMOA1310; 04FMOA1176; 04FMOB1359; 04FMOB1509; 04FMOB1815",".","7 Units","Blood products, collected from a donor who received a tattoo within 12 months of donation, were distributed.",2/7/2005,"02/07/2005",6/19/2013,"06/19/2013"
"Biologics",39760,"Terminated","Central Kentucky Blood Center, Inc.","Lexington","KY","US","Voluntary: Firm Initiated","Letter","Kentucky","B-1917-13","Class II","Platelets Pheresis Leukocytes Reduced Irradiated","2069982",".","1 unit","Blood products, collected from a donor who reported travel to a malarial endemic area, were distributed",3/22/2005,"03/22/2005",8/14/2013,"08/14/2013"
"Biologics",39760,"Terminated","Central Kentucky Blood Center, Inc.","Lexington","KY","US","Voluntary: Firm Initiated","Letter","Kentucky","B-1918-13","Class II","Platelets Pheresis Leukocytes Reduced","2086318; 1998668; 2019185; 2024609",".","4 units","Blood products, collected from a donor who reported travel to a malarial endemic area, were distributed",3/22/2005,"03/22/2005",8/14/2013,"08/14/2013"
"Biologics",39765,"Terminated","American Red Cross Blood Services","Saint Louis","MO","US","Voluntary: Firm Initiated","Telephone","MO","B-0364-13","Class II","Red Blood Cells","11FM49562",".","1 unit","Blood product, positive for the S-antigen but labeled as S-antigen negative, was distributed.",2/1/2005,"02/01/2005",1/23/2013,"01/23/2013"
"Biologics",39775,"Terminated","Northwest Florida Blood Center, Inc.","Pensacola","FL","US","Voluntary: Firm Initiated","Letter","FL","B-1178-13","Class II","Red Blood Cells (Apheresis) Leukocytes Reduced Irradiated","4663294- part 1 & 2",,"2 units","Blood products, which were not manufactured in accordance to acceptable product specifications, were distributed. ",2/3/2005,"02/03/2005",5/22/2013,"05/22/2013"
"Biologics",39775,"Terminated","Northwest Florida Blood Center, Inc.","Pensacola","FL","US","Voluntary: Firm Initiated","Letter","FL","B-1177-13","Class II","Red Blood Cells (Apheresis) Leukocytes Reduced","4663295- part 1 & 2; 4663335- part 1 & 2; 4663316- part 1 & 2; 4664074- part 1 & 2; 4664066- part 1 & 2; 4664042- part 1; 4664053- part 2; 4664223-part 1 & 2 ; 4664230- part 1 & 2; 4666036- part 1 & 2; 4663143- part 1 & 2; 4663162- part 1 & 2; 4664236- part 1 & 2 ",,"26 units","Blood products, which were not manufactured in accordance to acceptable product specifications, were distributed. ",2/3/2005,"02/03/2005",5/22/2013,"05/22/2013"
"Biologics",39798,"Terminated","American National Red Cross (The)","Salt Lake City","ID","US","Voluntary: Firm Initiated","FAX","California, Idaho.","B-0890-13","Class III","Red Blood Cells Leukocytes Reduced","020LE04030, 020LE04031, 020LE04032, 020LE04033, 020LE04034, 020LE04035, 020LE04036, 020LE04037, 020LE04038, 020LE04039, 020LE04040, 020LE04041, 020LE04042, 020LE04043, 020LE04044.",,"15 units","Blood products, in which instrument QC or validation was unacceptable were distributed.",3/9/2005,"03/09/2005",4/3/2013,"04/03/2013"
"Biologics",39800,"Terminated","American National Red Cross (The)","Boise","ID","US","Voluntary: Firm Initiated","Telephone","California.","B-0772-13","Class II","Red Blood Cells Leukocytes Reduced","20LF61216",,"1 unit","Blood product, collected from a donor whose health history screening was inadequately performed, was distributed.",2/15/2005,"02/15/2005",4/3/2013,"04/03/2013"
"Biologics",39836,"Terminated","Community Blood Center of the Ozarks","Springfield","MO","US","Voluntary: Firm Initiated","Letter","MO; Austria","B-0934-13","Class II","Blood and Blood Products for Reprocessing","4225682",".","1 unit","Blood products, collected from a donor who received a piercing within 12 months of donation, were distributed.",3/21/2005,"03/21/2005",4/10/2013,"04/10/2013"
"Biologics",39836,"Terminated","Community Blood Center of the Ozarks","Springfield","MO","US","Voluntary: Firm Initiated","Letter","MO; Austria","B-0935-13","Class II","Red Blood Cells","4225682",".","1 Unit","Blood products, collected from a donor who received a piercing within 12 months of donation, were distributed",3/21/2005,"03/21/2005",4/10/2013,"04/10/2013"
"Biologics",39842,"Terminated","American Red Cross Blood Services","Omaha","NE","US","Voluntary: Firm Initiated","Letter","NB","B-1647-13","Class II","Fresh Frozen Plasma (Apheresis)","09FP49574",".","1 Unit","Blood products, collected from an unsuitable donor based on risk factors for variant Creutzfeldt-Jakob Disease (vCJD), were distributed.",2/25/2005,"02/25/2005",7/10/2013,"07/10/2013"
"Biologics",39842,"Terminated","American Red Cross Blood Services","Omaha","NE","US","Voluntary: Firm Initiated","Letter","NB","B-1646-13","Class II","Platelets Pheresis Leukocytes Reduced","09FP49574",".","1 Unit","Blood products, collected from an unsuitable donor based on risk factors for variant Creutzfeldt-Jakob Disease (vCJD), were distributed.",2/25/2005,"02/25/2005",7/10/2013,"07/10/2013"
"Biologics",39848,"Terminated","American Red Cross Blood Services","Wichita","KS","US","Voluntary: Firm Initiated","Telephone","Kansas City, Kentucky, Missouri","B-1578-13","Class II","Red Blood Cells Leukocytes Reduced Irradiated","02FN07714; 02FN07715",,"2 units","Blood products, collected from donors that used the incorrect version of the BDR, were distributed.",2/17/2005,"02/17/2005",7/3/2013,"07/03/2013"
"Biologics",39848,"Terminated","American Red Cross Blood Services","Wichita","KS","US","Voluntary: Firm Initiated","Telephone","Kansas City, Kentucky, Missouri","B-1579-13","Class II","Fresh Frozen Plasma","02FN07716; 02FN07717; 02FN07718",,"3 units","Blood products, collected from donors that used the incorrect version of the BDR, were distributed.",2/17/2005,"02/17/2005",7/3/2013,"07/03/2013"
"Biologics",39848,"Terminated","American Red Cross Blood Services","Wichita","KS","US","Voluntary: Firm Initiated","Telephone","Kansas City, Kentucky, Missouri","B-1576-13","Class II","Red Blood Cells Deglycerolized","02FN07700",,"1 unit","Blood products, collected from donors that used the incorrect version of the BDR, were distributed.",2/17/2005,"02/17/2005",7/3/2013,"07/03/2013"
"Biologics",39848,"Terminated","American Red Cross Blood Services","Wichita","KS","US","Voluntary: Firm Initiated","Telephone","Kansas City, Kentucky, Missouri","B-1577-13","Class II","Red Blood Cells"," 02FN07716; 02FN07717; 02FN07718",,"3 units","Blood products, collected from donors that used the incorrect version of the BDR, were distributed.",2/17/2005,"02/17/2005",7/3/2013,"07/03/2013"
"Biologics",39848,"Terminated","American Red Cross Blood Services","Wichita","KS","US","Voluntary: Firm Initiated","Telephone","Kansas City, Kentucky, Missouri","B-1581-13","Class II","Red Blood Cells Leukocytes Reduced","02FN07713",,"1 unit","Blood products, collected from donors that used the incorrect version of the BDR, were distributed.",2/17/2005,"02/17/2005",7/3/2013,"07/03/2013"
"Biologics",39848,"Terminated","American Red Cross Blood Services","Wichita","KS","US","Voluntary: Firm Initiated","Telephone","Kansas City, Kentucky, Missouri","B-1580-13","Class III","Blood and Blood Products for Reprocessing","02FN07700; 02FN07701; 02FN07713; 02FN07714; 02FN07715",,"5 units","Blood products, collected from donors that used the incorrect version of the BDR, were distributed.",2/17/2005,"02/17/2005",7/3/2013,"07/03/2013"
"Biologics",39864,"Terminated","Community Blood Centers of South Florida, Inc.","Lauderhill","FL","US","Voluntary: Firm Initiated","FAX","FL","B-1165-13","Class II","Fresh Frozen Plasma","1506379",".","1 unit","Blood product, labeled with an incorrect expiration date, was distributed.",3/7/2005,"03/07/2005",5/29/2013,"05/29/2013"
"Biologics",39897,"Terminated","American National Red Cross","Boise","ID","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Canada.","B-1137-13","Class II","Plasma Frozen","20LS22612, 20LS22562, 20LY56192. ",".","3 units","Blood products, collected from a donor who was in close contact with an individual diagnosed with viral hepatitis, were distributed.",3/4/2005,"03/04/2005",5/15/2013,"05/15/2013"
"Biologics",39897,"Terminated","American National Red Cross","Boise","ID","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Canada.","B-1136-13","Class II","Red Blood Cells Leukocytes Reduced Washed","20LS22919.",".","1 unit","Blood products, collected from a donor who was in close contact with an individual diagnosed with viral hepatitis, were distributed.",3/4/2005,"03/04/2005",5/15/2013,"05/15/2013"
"Biologics",39897,"Terminated","American National Red Cross","Boise","ID","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Canada.","B-1135-13","Class II","Fresh Frozen Plasma","20lS22585 , 20LS22487 , 20LS22490 , 20LS22594 , 20LS22622 , 20LS22794 , 20LS22784 , 20LS22789 , 20LS22800 , 20LS22801 , 20LS22808 , 20LS22744 , 20LY56070, 20LS22797, 20LS22792, 20LS22357, 20LY56098, 20LS22352, 20LS22804, 20LS22354, 20LY56084, 20LY56087, 20LC72098, 20LS22785.",".","24 units","Blood products, collected from a donor who was in close contact with an individual diagnosed with viral hepatitis, were distributed.",3/4/2005,"03/04/2005",5/15/2013,"05/15/2013"
"Biologics",39897,"Terminated","American National Red Cross","Boise","ID","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Canada.","B-1134-13","Class II","Red Blood Cells Leukocytes Reduced","20LY55510 , 20LY55518 , 20LS22792 , 20LS22257 , 20LS22898 , 20lC72098 , 20LY56192 , 20LS22666 , 20LS22667 , 20LS22801 , 20LS22923 , 20LS22744 , 20LS22729 , 20LS22746 , 20lS22562, 20LY56070, 20LS22616, 20LS22684 , 20LS22800, 20LS22808 , 20LS22965, 20LS22967, 20LS22997, 20LS23042 , 20LY56948, 20LS22622 , 20LS22757, 20LS22760 , 20LS22865, 20LY56958, 20LS22585, 20LS22594, 20LY56098, 20LY56084, 20LS22354, 20LS22459, 20LY56075, 20LY56090, 20LS22784, 20LS22789, 20LS22794, 20LS22802, 20LS22938, 20LY56087, 20LY56095, 20LS22352, 20LS22487, 20LS22785, 20LS22490, 20LZ27028, 20LS22589, 20LS22726, 20LS22734, 20LS22737, 20LS22721, 20LS22795, 20LS22797, 20LS22804, 20LS22357, 20LY56078.",".","60 units","Blood products, collected from a donor who was in close contact with an individual diagnosed with viral hepatitis, were distributed.",3/4/2005,"03/04/2005",5/15/2013,"05/15/2013"
"Biologics",39944,"Terminated","Tri-counties Blood Bank","San Luis Obispo","CA","US","Voluntary: Firm Initiated","Telephone","California","B-1964-13","Class III","Red Blood Cells Leukocytes Reduced","LF32774",".","1 unit","Blood product, which was not quarantined after receiving post donation information concerning an illness following donation, was distributed.",3/7/2005,"03/07/2005",8/14/2013,"08/14/2013"
"Biologics",39982,"Terminated","Community Blood Center of the Ozarks","Springfield","MO","US","Voluntary: Firm Initiated","Letter","Missouri","B-0304-13","Class II","Red Blood Cells","6557165",".","1 unit","Blood product, which did not meet the acceptable product specifications, was distributed.",4/28/2005,"04/28/2005",1/2/2013,"01/02/2013"
"Biologics",39986,"Terminated","Mississippi Valley Reg Bld Ctr","Davenport","IA","US","Voluntary: Firm Initiated","Telephone","Illinois","B-0495-13","Class II","Red Blood Cells","T23108",".","1 Unit","Blood product, manufactured from an overweight whole blood unit, was distributed.",4/7/2005,"04/07/2005",2/6/2013,"02/06/2013"
"Biologics",39991,"Terminated","American National Red Cross (The)","Salt Lake City","UT","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","CA, OK, TX, UT, and NV","B-0942-13","Class II","Fresh Frozen Plasma","20M38857, 20M38862, 20M38872, 20V83519, 20E34679, 20E34885, 20E34890, 20E34901, 20V83521. ",".","9 units","Blood products, collected from donors, whose suitability to donate was not adequately determined, were distributed.",3/17/2005,"03/17/2005",5/29/2013,"05/29/2013"
"Biologics",39991,"Terminated","American National Red Cross (The)","Salt Lake City","UT","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","CA, OK, TX, UT, and NV","B-0944-13","Class II","Red Blood Cells Leukocytes Reduced Irradiated","20M38861",".","1 unit","Blood products, collected from donors whose suitability to donate was not adequately determined, were distributed.",3/17/2005,"03/17/2005",5/29/2013,"05/29/2013"
"Biologics",39991,"Terminated","American National Red Cross (The)","Salt Lake City","UT","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","CA, OK, TX, UT, and NV","B-0941-13","Class II","Red Blood Cells Leukocytes Reduced","20E34887, 20E34890, 20E34899, 20E34906, 20J98100, 20J98716, 20M38841, 20M38847, 20M38849, 20M3B852, 20M38854, 20M38872, 20VB3505, 20V83514, 20V83516, 20V83519, 20E34908, 20E34910, 20J98110, 20J98713, 20J98723, 20M38831, 20M38838, 20M38857, 20M38862, 20V83510, 20M38834, 20J98721, 20M38840, 20J98684, 20E34879, 20J98698, 20J98103, 20M38870, 20V83S21, 20J98718, 20E34885, 20E34894, 20M38856, 20M38858, 20M38866, 20J98677, 20M38864, 20M38869, 20J98688, 20E34901.",".","46 units","Blood products, collected from donors, whose suitability to donate was not adequately determined, were distributed.",3/17/2005,"03/17/2005",5/29/2013,"05/29/2013"
"Biologics",39991,"Terminated","American National Red Cross (The)","Salt Lake City","UT","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","CA, OK, TX, UT, and NV","B-0943-13","Class III","Blood and Blood Products for Reprocessing","20E34894, 20E34899, 20E34906, 20E34908, 20E34910, 20J98677, 20J98684, 20J98688, 20J9B698, 20J98700, 20J98703, 20J98710, 20J98713 , 20J98716, 20J98718, 20J98721, 20J98723, 20M38831, 20M38834, 20M38838, 20M38840, 20M38841, 20M38847, 20M38849, 20M38852, 20M38854, 20M38856, 20M38858, 20M38861, 20M38864, 20M38866, 20M38869, 20M38870, 20V83505, 20V83510, 20V83514, 20V83516, 20M40659, 20M40662, 20M40664, 20M40674.",".","41 units","Blood products, collected from donors, whose suitability to donate was not adequately determined, were distributed.",3/17/2005,"03/17/2005",5/29/2013,"05/29/2013"
"Biologics",39995,"Terminated","ZLB Bioplasma, Inc.","Columbus","OH","US","Voluntary: Firm Initiated","FAX","IL, CA","B-1982-13","Class III","Source Plasma","GFKWMV;GFKXMW; GFLCNS; GFLDJG; GFLFPV; GFLGJT; GFLHQF; GFLJHW; GFLKKC; GFMDZG; GFMGBS; GFMGTN; GFMHXS; GFMJMT; GFMKHX; GFMMBQ; GFMMWS; GFMPJS; GFMQFC; GFMRMP; GFMSVC; GFMVBP; GFMPDV; GFYBVS; GFYCYF; GFYFDR; GFYGLW; GFYGYN; GFYJFM; GFYJTT; GFYKZL; GFYLYK; GFYNZL; GFZHLG; GFZJGY; GFZKMW; GFZLNH; GFZMJH; GFZNFN; GFZPFH; GFZPVM; GFZQPL; GFZRGV; JBBRWK; JBBZYZ",,"46 units","Blood products, collected from a donor who was at risk for variant Creutzfeldt-Jakob disease (vCJD), were distributed.",2/25/2005,"02/25/2005",8/7/2013,"08/07/2013"
"Biologics",39999,"Terminated","American National Red Cross (The)","Boise","ID","US","Voluntary: Firm Initiated","FAX","Distributed to a medical center in Idaho.","B-0792-13","Class II","Red Blood Cells Leukocytes Reduced","20LN57900",".","1 component","Blood product, collected from a donor who traveled to a malarial endemic area, was distributed.",3/24/2005,"03/24/2005",3/27/2013,"03/27/2013"
"Biologics",40010,"Terminated","DCI Biologicals Orlando LLC","Gainesville","FL","US","Voluntary: Firm Initiated","FAX","United Kingdom","B-1233-13","Class II","Source Plasma","GN0034097; GN0034652; GN0034726; GN0035205; GN0035272; GN0035915; GN0036133",".","7 units","Blood products, collected from a donor who subsequently reported a tattoo, were distributed",4/28/2005,"04/28/2005",5/29/2013,"05/29/2013"
"Biologics",40040,"Terminated","Biomat USA, Inc.","Phoenix","AZ","US","Voluntary: Firm Initiated","FAX","Spain","B-2053-13","Class III","Source Plasma","0230045965, 0230046276 ",".","2 units","Blood products, collected from a donor who was at risk for variant Creutzfeldt-Jakob disease (vCJD), were distributed.",4/28/2005,"04/28/2005",8/28/2013,"08/28/2013"
"Biologics",40045,"Terminated","Biomat USA, Inc.","Phoenix","AZ","US","Voluntary: Firm Initiated","FAX","CA, Spain","B-2052-13","Class III","Source Plasma","0230005934 0230006594 0230007010 0230007704 0230008026 0230008774 0230009105 0230009716 0230010053 0230010737 0230011090 0230011783 0230012190 0230012866 0230013242 0230013874 0230014166 0230014835 0230015137 0230015838 0230016157 0230016877 0230017197 0230017916 0230018140 0230018821 0230019107 0230019832 0230020173 0230020889 0230021231 0230022001 0230022295 0230023406 0230023699 0230024368 0230024663",".","37 units","Blood products, which were collected from a donor with a history of living with someone who is HIV positive, were distributed.",4/5/2005,"04/05/2005",8/28/2013,"08/28/2013"
"Biologics",40103,"Terminated","ZLB Bioplasma, Inc.","Ft. Collins","CO","US","Voluntary: Firm Initiated","FAX","NC, Switzerland","B-0647-13","Class II","Source Plasma","7050250350; 7050249999; 7050249438; 7050248725; 7050248427; 7050247466; 7050246334; 7050245972; 7050244385; 7050247190; 7050242563; 7050232066; 7050231322; 7050230879; 7050230716; 7050213765; 7050213142; 7050255690; 7050212544; 7050212340; 7050211828; 7050211268; 7050209821; 7050209506; 7050209329",".","25 units","Blood products, collected from a donor who received a body piercing within 12 months of donating, were distributed.",4/22/2005,"04/22/2005",2/27/2013,"02/27/2013"
"Biologics",40111,"Terminated","American National Red Cross (The)","Boise","ID","US","Voluntary: Firm Initiated","Telephone","California.","B-0793-13","Class II","Red Blood Cells Leukocytes Reduced","020LN52994",".","1 component","Blood product, collected from a donor who traveled to an area considered endemic for malaria, was distributed.",4/21/2005,"04/21/2005",3/27/2013,"03/27/2013"
"Biologics",40132,"Terminated","Southern California Permanente Medical Group Blood Donor Ctr","Downey","CA","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","CA","B-1676-13","Class II","Platelets Pheresis","GP13388A; GP13388B; GP13276; GP13234",".","4 units","Blood products, which were collected from a donor who traveled to a malarial endemic area, were distributed.",5/27/2005,"05/27/2005",7/17/2013,"07/17/2013"
"Biologics",40144,"Terminated","Presbyterian Intercommunity Hospital, Inc. Blood Bank","Whittier","CA","US","Voluntary: Firm Initiated","Letter","CA","B-2031-13","Class II","Red Blood Cells Irradiated"," P57203",".","1 unit","Blood products, collected from a donor who was at risk for variant Creutzfeldt-Jakob Disease (vCJD), were distributed.",6/1/2005,"06/01/2005",8/14/2013,"08/14/2013"
"Biologics",40144,"Terminated","Presbyterian Intercommunity Hospital, Inc. Blood Bank","Whittier","CA","US","Voluntary: Firm Initiated","Letter","CA","B-2032-13","Class II","Fresh Frozen Plasma. "," P57203",".","1 unit","Blood products, collected from a donor who was at risk for variant Creutzfeldt-Jakob Disease (vCJD), were distributed.",6/1/2005,"06/01/2005",8/14/2013,"08/14/2013"
"Biologics",40148,"Terminated","LifeServe Blood Center","Sioux City","IA","US","Voluntary: Firm Initiated","Letter","FL, IA","B-0642-13","Class II","Red Blood Cells (Apheresis) Leukocytes Reduced","1978331;1978331",".","2 units","Blood product, collected from a donor who reported travel to a malarial endemic area, was distributed.",4/25/2005,"04/25/2005",2/27/2013,"02/27/2013"
"Biologics",40172,"Terminated","American National Red Cross (The)","Saint Louis","MO","US","Voluntary: Firm Initiated","Letter","MO","B-0221-13","Class II","Red Blood Cells Leukocytes Reduced","011GF47386",,"1 unit","Blood product, manufactured from a unit of whole blood lacking hematocrit documentation, was distributed.",5/6/2005,"05/06/2005",3/13/2013,"03/13/2013"
"Biologics",40181,"Terminated","Tri-Counties Blood Bank dba UBS- Central Coast","Phoenix","AZ","US","Voluntary: Firm Initiated","Letter","AZ, CA","B-1826-13","Class II","Red Blood Cells Leukocytes Reduced","LF32303",,"1 unit","Blood products, collected from a donor who traveled to a malarial endemic area, were distributed. ",6/24/2005,"06/24/2005",7/31/2013,"07/31/2013"
"Biologics",40181,"Terminated","Tri-Counties Blood Bank dba UBS- Central Coast","Phoenix","AZ","US","Voluntary: Firm Initiated","Letter","AZ, CA","B-1827-13","Class II","Platelets Pheresis Leukocytes Reduced","LF33971; LF32872; LF32576; LF34288",,"4 units","Blood products, collected from a donor who traveled to a malarial endemic area, were distributed. ",6/24/2005,"06/24/2005",7/31/2013,"07/31/2013"
"Biologics",40188,"Terminated","ZLB Bioplasma, Inc.","Evans","CO","US","Voluntary: Firm Initiated","FAX","IL","B-0640-13","Class II","Source Plasma","6150025377;6150024781;6150024580;6150021661;6150021487;6150020920;6150025471",,"7 units","Blood products, collected from a donor whose physical was overdue, were distributed.",5/11/2005,"05/11/2005",3/20/2013,"03/20/2013"
"Biologics",40191,"Terminated","Blood Bank of San Bernardino and Riverside Counties","San Bernardino","CA","US","Voluntary: Firm Initiated","Letter","California, Washington DC, Switzerland","B-1784-13","Class II","Red Blood Cells","GQ24012; GQ16732; GL53069",".","3 units","Blood products, collected from a donor taking the medication Purinethol, were distributed.",5/25/2005,"05/25/2005",7/17/2013,"07/17/2013"
"Biologics",40191,"Terminated","Blood Bank of San Bernardino and Riverside Counties","San Bernardino","CA","US","Voluntary: Firm Initiated","Letter","California, Washington DC, Switzerland","B-1786-13","Class II","Red Blood Cells Leukocytes Reduced","GQ46933; GQ42775",".","2 units","Blood products, collected from a donor taking the medication Purinethol, were distributed.",5/25/2005,"05/25/2005",7/17/2013,"07/17/2013"
"Biologics",40191,"Terminated","Blood Bank of San Bernardino and Riverside Counties","San Bernardino","CA","US","Voluntary: Firm Initiated","Letter","California, Washington DC, Switzerland","B-1785-13","Class II","Fresh Frozen Plasma","GQ24012; GL53069",".","2 units","Blood products, collected from a donor taking the medication Purinethol, were distributed.",5/25/2005,"05/25/2005",7/17/2013,"07/17/2013"
"Biologics",40204,"Terminated","Community Blood Centers of South Florida, Inc.","Lauderhill","FL","US","Voluntary: Firm Initiated","Telephone","MI, FL","B-1173-13","Class II","Red Blood Cells Frozen Rejuvenated","1770439",".","1 unit","Blood products, labeled with the incorrect expiration date, were distributed.",6/9/2005,"06/09/2005",5/29/2013,"05/29/2013"
"Biologics",40204,"Terminated","Community Blood Centers of South Florida, Inc.","Lauderhill","FL","US","Voluntary: Firm Initiated","Telephone","MI, FL","B-1172-13","Class II","Platelets","1770441;1770439;1770438",".","3 units","Blood products, labeled with the incorrect expiration date, were distributed.",6/9/2005,"06/09/2005",5/29/2013,"05/29/2013"
"Biologics",40223,"Terminated","Tri-Counties Blood Bank","Santa Barbara","CA","US","Voluntary: Firm Initiated","Letter","CA","B-2043-13","Class II","Red Blood Cells Leukocytes Reduced","LF32302- part 1;LF32302- part 2",,"2 units","Blood products, collected from a donor who traveled to a malarial endemic area, were distributed.",6/24/2005,"06/24/2005",8/21/2013,"08/21/2013"
"Biologics",40232,"Terminated","Community Blood Bank of Lancaster County Medical Society","Lincoln","NE","US","Voluntary: Firm Initiated","FAX","NE, FL","B-0273-13","Class II","Red Blood Cells (Apheresis) Leukocytes Reduced","6519597; 6519597",,"2 units","Blood products, which did not meet the acceptable product specifications, were distributed.",5/17/2005,"05/17/2005",3/13/2013,"03/13/2013"
"Biologics",40232,"Terminated","Community Blood Bank of Lancaster County Medical Society","Lincoln","NE","US","Voluntary: Firm Initiated","FAX","NE, FL","B-0274-13","Class II","Red Blood Cells Leukocytes Reduced","6032691; 6032687; 6032679; 6032689; 6519587",,"5 units","Blood products, which did not meet the acceptable product specifications, were distributed.",5/17/2005,"05/17/2005",3/13/2013,"03/13/2013"
"Biologics",40243,"Terminated","American National Red Cross (The)","Salt Lake City","UT","US","Voluntary: Firm Initiated","Telephone","California, Idaho.","B-0917-13","Class II","Red Blood Cells Leukocytes Reduced","020LC73053, 020LC74275. ",,"2 units","Blood products, which were collected from a donor who traveled to malarial endemic areas, were distributed",5/12/2005,"05/12/2005",4/17/2013,"04/17/2013"
"Biologics",40317,"Terminated","American Red Cross Blood Services","Saint Louis","MO","US","Voluntary: Firm Initiated","Letter","Missouri","B-0167-13","Class II","Platelets Pheresis Leukocytes Reduced","011LF20539",".","1 Unit","Blood product, with platelet yield that exceeded the manufacturer's limit for the product to be stored in one bag, was distributed.",5/27/2005,"05/27/2005",1/23/2013,"01/23/2013"
"Biologics",40349,"Terminated","Northwest Florida Blood Center, Inc.","Pensacola","FL","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Florida","B-1313-13","Class III","Red Blood Cells Leukocytes Reduced","4952908",".","1 unit","Blood product, manufactured from Whole Blood units that may have had an extended collection time, was distributed.",6/16/2004,"06/16/2004",6/5/2013,"06/05/2013"
"Biologics",40353,"Terminated","Northwest Florida Blood Center, Inc.","Pensacola","FL","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Florida","B-0918-13","Class II","Red Blood Cells Leukocytes Reduced"," 4509454.",,"1 unit","Blood product, collected from a donor, whose suitability to donate was not adequately determined, was distributed.",6/17/2004,"06/17/2004",4/17/2013,"04/17/2013"
"Biologics",40385,"Terminated","Mississippi Valley Reg Bld Ctr","Davenport","IA","US","Voluntary: Firm Initiated","FAX","Tennessee","B-0496-13","Class II","Fresh Frozen Plasma","Y42952",".","1 Unit","Blood product, collected from a donor who was at risk for variant Creutzfeldt-Jakob disease (vCJD), was distributed.",7/18/2005,"07/18/2005",2/6/2013,"02/06/2013"
"Biologics",40401,"Terminated","Biomat USA, Inc.","Mesa","AZ","US","Voluntary: Firm Initiated","FAX","Spain","B-2197-13","Class III","Source Plasma","0210062043 0210062481 0210063444 0210063852 0210064554 0210064603 0210065081 0210065608 0210065837 0210066266 0210066480 0210067362 0210067724 0210067973 0210068300 0210068633 0210068854 0210069332 0210069618 0210070022 0210070334 0210070650 0210070994 0210071289",".","24 units","Blood products, collected from a donor whose suitability to donate were not adequately determined, were distributed.",6/29/2005,"06/29/2005",9/11/2013,"09/11/2013"
"Biologics",40404,"Terminated","San Diego Blood Bank","San Diego","CA","US","Voluntary: Firm Initiated","Letter","CA","B-2044-13","Class II","Red Blood Cells Leukocytes Reduced","C76634",,"1 unit","Blood product, collected from a donor who was at risk for variant Creutzfeldt-Jakob disease (vCJD), was distributed.",7/26/2005,"07/26/2005",8/21/2013,"08/21/2013"
"Biologics",40404,"Terminated","San Diego Blood Bank","San Diego","CA","US","Voluntary: Firm Initiated","Letter","CA","B-2045-13","Class II","Blood and Blood Products for Reprocessing","C76634",,"1 unit","Blood product, collected from a donor who was at risk for variant Creutzfeldt-Jakob disease (vCJD), was distributed.",7/26/2005,"07/26/2005",8/21/2013,"08/21/2013"
"Biologics",40408,"Terminated","American National Red Cross (The)","Pomona","CA","US","Voluntary: Firm Initiated","Telephone","Poway, California and Escondido, California","B-1675-13","Class II","Red Blood Cells","06GY28769; 06GY28770",".","2","Blood products, tested for communicable diseases using unsuitable samples, were distributed. ",6/16/2004,"06/16/2004",8/14/2013,"08/14/2013"
"Biologics",40412,"Terminated","American National Red Cross (The)","Pomona","CA","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","CA","B-0923-13","Class II","Platelets Pheresis Leukocytes Reduced Irradiated","06KC70987; 06KY05829",".","2 units","Blood products, which did not meet acceptable product specifications, were distributed.",8/1/2005,"08/01/2005",4/10/2013,"04/10/2013"
"Biologics",40414,"Terminated","American National Red Cross (The)","Pomona","CA","US","Voluntary: Firm Initiated","Letter","California","B-2502-13","Class III","Platelets Pheresis Leukocytes Reduced Irradiated","06KK04287, 06KK0428806, KK04193, 06KK04267, 06KK04130",,"5 units","Blood products, in which quality control and distribution of products did not meet specifications, were distributed.",8/1/2005,"08/01/2005",11/6/2013,"11/06/2013"
"Biologics",40414,"Terminated","American National Red Cross (The)","Pomona","CA","US","Voluntary: Firm Initiated","Letter","California","B-2503-13","Class III","Platelets Pheresis Leukocytes Reduced","06KK04290, 06KH10582, 06KK04291, 06KK04130 ",,"4 units","Blood products, in which quality control and distribution of products did not meet specifications, were distributed.",8/1/2005,"08/01/2005",11/6/2013,"11/06/2013"
"Biologics",40418,"Completed","American National Red Cross","Portland","OR","US","Voluntary: Firm Initiated",,"CA, WA, OR, MT","B-2012-13","Class II","Cryoprecipitated AHF, Pooled","21KW38284, 21KW38305, 21KW38318, 21LJ19103, 21LJ19112.",,"5 units","Blood products, collected from donors whose suitability to donate was not adequately determined, were distributed.",6/24/2005,"06/24/2005",8/21/2013,"08/21/2013"
"Biologics",40418,"Completed","American National Red Cross","Portland","OR","US","Voluntary: Firm Initiated",,"CA, WA, OR, MT","B-2011-13","Class II","Red Blood Cells Leukocytes Reduced","21KW38284, 21KW38318, 21LG22846, 21LG22848, 21LG22850, 21LG22852, 21LG22862, 21LG22865, 21LH23206, 21LH23222, 21LH23229, 21LH23243, 21LH23280, 21LH23295, 21LH23458, 21LH23461, 21LH23476, 21LH23478, 21LJ18992, 21LJ18996, 21LJ19001, 21LJ19007, 21LJ19014, 21LJ19019, 21LJ19021, 21LJ19036, 21LJ19047, 21LJ19054, 21LJ19061, 21LJ19076, 21LJ19088, 21LJ19100, 21LJ19103, 21LJ19107, 21LJ19112, 21LJ19116, 21LJ19120, 21LJ19124, 21LJ19129, 21LJ19131, 21LJ19134, 21LJI8974, 21LJI8981, 21LJI8998, 21Y94408, 21Y94427, 21Y94442.",,"47 units","Blood products, collected from donors whose suitability to donate was not adequately determined, were distributed.",6/24/2005,"06/24/2005",8/21/2013,"08/21/2013"
"Biologics",40418,"Completed","American National Red Cross","Portland","OR","US","Voluntary: Firm Initiated",,"CA, WA, OR, MT","B-2013-13","Class II","Cryoprecipitated AHF","21LG22862, 21LJ19047, 21LJ19100",,"3 units","Blood products, collected from donors whose suitability to donate was not adequately determined, were distributed.",6/24/2005,"06/24/2005",8/21/2013,"08/21/2013"
"Biologics",40483,"Terminated","American National Red Cross (The)","Pomona","CA","US","Voluntary: Firm Initiated","Telephone","California","B-1500-13","Class II","Red Blood Cells Leukocytes Reduced","06FW99249",,"1","Blood product, which tested positive for S antigen, but was labeled as S antigen negative, was distributed.distributed..",7/1/2005,"07/01/2005",6/26/2013,"06/26/2013"
"Biologics",40489,"Terminated","HemaCare Corporation","Sherman Oaks","CA","US","Voluntary: Firm Initiated","Letter","California","B-1795-13","Class II","Red Blood Cells Leukocytes Reduced"," 4025560",".","1 unit","Blood products, labeled with an incorrect ABO type, were distributed.",8/10/2005,"08/10/2005",7/17/2013,"07/17/2013"
"Biologics",40489,"Terminated","HemaCare Corporation","Sherman Oaks","CA","US","Voluntary: Firm Initiated","Letter","California","B-1794-13","Class II","Fresh Frozen Plasma","40225560",".","1 unit","Blood products, labeled with an incorrect ABO type, were distributed.",8/10/2005,"08/10/2005",7/17/2013,"07/17/2013"
"Biologics",40532,"Terminated","Tri-Counties Blood Bank","Santa Barbara","CA","US","Voluntary: Firm Initiated","Letter","CA","B-2095-13","Class II","Platelet Pheresis Leukocytes Reduced","LF41291",,"1 unit","Blood product, with a low platelet count, was distributed.",8/12/2005,"08/12/2005",8/21/2013,"08/21/2013"
"Biologics",40591,"Terminated","American Red Cross Blood Services","Saint Louis","MO","US","Voluntary: Firm Initiated","E-Mail","MO, IL, AL, SC, MI, PR, France","B-1127-13","Class II","Platelets. The responsible firm listed on the product label is American Red Cross Blood Services.","11LE27830 ",".","1 unit","Blood products, which were collected in a manner that may have compromised the sterility of the collection system, were distributed.",7/6/2005,"07/06/2005",5/15/2013,"05/15/2013"
"Biologics",40591,"Terminated","American Red Cross Blood Services","Saint Louis","MO","US","Voluntary: Firm Initiated","E-Mail","MO, IL, AL, SC, MI, PR, France","B-1126-13","Class II","Cryoprecipitated AHF. The responsible firm listed on the product label is American Red Cross Blood Services.","11GK84919 11GK84923 11GK84925 11GK84926 11GK84928 11GK84930 11GK84932 ",".","7 units","Blood products, which were collected in a manner that may have compromised the sterility of the collection system, were distributed.",7/6/2005,"07/06/2005",5/15/2013,"05/15/2013"
"Biologics",40591,"Terminated","American Red Cross Blood Services","Saint Louis","MO","US","Voluntary: Firm Initiated","E-Mail","MO, IL, AL, SC, MI, PR, France","B-1122-13","Class II","Red Blood Cells Leukocytes Reduced. The responsible firm listed on the product label is American Red Cross Blood Services.","11KC13068 11KL07945 11KL08058 11LZ28121 11LZ28895 11GP17262 11GP17265 11GP17267 11GP17268 11LE26225 11LC92484 11LC92498 11KL08331 11KL08340 11KL08348 11KL08351 11KL08352 11KL08440 11KL08455 11KL08479 11LQ39167 11LQ39169 11LQ39171 11LQ39175 11LQ39217 11LQ39227 11KE50300 11KE50301 11KE50305 11KE50306 11KE50310 11KE50320 11KE50321 11KE50326 11LE26545 11LE26548 11LE26554 11LE26563 11LE26575 11LE26622 11LE26627 11LE26632 11LE26687 11KY07350 11KY07378 11LE27054 11KV05165 11KV05167 11KV05184 11LE27087 11LE27171 11LE27182 11LE27187 11LE27199 11KV05213 11KV05223 11KV05225 11KV05291 11KY07612 11KY07615 11KY07641 11KY07642 11KY07645 11KY07647 11KY07668 11KY07670 11LC92853 11LC92861 11LE27516 11LE27590 11KY07906 11LE27631 11LE27638 11LE27681 11GK84919 11GK84923 11GK84925 11GK84926 11GK84928 11GK84932 11LC93202 11LC93210 11LC93211 11FK12571 11FK12573 11FK12582 11FK12689 11FK12691 11FK12693 11FK12694 11FK12708 11FK12709 11FK12710 11LJ92818 11LJ92822 11LJ92828 11LJ92830 11LJ92837 11KY08219 11KY08225 11KV06093 11KV06098 11KV06115 11KV06117 11KV06120 11KV06122 11KV06126 11KV06140 11KV06203 11KV06217 11KV06226 11KV08262 11KV06095 11KV06102 11KV06145 11LE27829 ",".","116 units","Blood products, which were collected in a manner that may have compromised the sterility of the collection system, were distributed.",7/6/2005,"07/06/2005",5/15/2013,"05/15/2013"
"Biologics",40591,"Terminated","American Red Cross Blood Services","Saint Louis","MO","US","Voluntary: Firm Initiated","E-Mail","MO, IL, AL, SC, MI, PR, France","B-1123-13","Class II","Plasma Frozen. The responsible firm listed on the product label is American Red Cross Blood Services.","11LE26225 11LE26231 11LE26234 11LC92535 11KE50301 11KE50310 11KE50315 11KE50320 11KE50321 11KE50326 11KE50329 11LE26545 11LE26563 11LE26687 11LE26697 11LE27044 11KV05167 11LE27080 11LE27087 11LE27154 11LE27175 11KV05273 11KY07615 11KY07633 11KY07639 11KY07645 11LC92861 11LE27502 11KV05636 11KV05639 11LE27581 11LJ92554 11LJ92559 11LJ92562 11LE27587 11LE27589 11LE27590 11LE27631 11LE27638 11LE27681 ",".","40 units","Blood products, which were collected in a manner that may have compromised the sterility of the collection system, were distributed.",7/6/2005,"07/06/2005",5/15/2013,"05/15/2013"
"Biologics",40591,"Terminated","American Red Cross Blood Services","Saint Louis","MO","US","Voluntary: Firm Initiated","E-Mail","MO, IL, AL, SC, MI, PR, France","B-1125-13","Class II","Fresh Frozen Plasma. The responsible firm listed on the product label is American Red Cross Blood Services.","11LZ28895 11GP17262 11GP17265 11GP17267 11GP17268 ",".","5 units","Blood products, which were collected in a manner that may have compromised the sterility of the collection system, were distributed.",7/6/2005,"07/06/2005",5/15/2013,"05/15/2013"
"Biologics",40591,"Terminated","American Red Cross Blood Services","Saint Louis","MO","US","Voluntary: Firm Initiated","E-Mail","MO, IL, AL, SC, MI, PR, France","B-1124-13","Class II","Red Blood Cells. The responsible firm listed on the product label is American Red Cross Blood Services.","11LC92381 11LC92384 11LC92388 11LC92390 11LE26231 11LE26234 11LC92535 11LQ39216 11LE26681 11LE26697 11LE26704 11LE26741 11LE27040 11LE27044 11LE27052 11KV05210 11KV05217 11KV05220 11KV05244 11LQ39475 11LQ39479 11LQ39501 11LQ39502 11KV05273 11KV05292 11KY07606 11KY07607 11KY07633 11KY07639 11LC92854 11LC92855 11LC92857 11LC92858 11KV05636 11KV05639 11KV05640 11KV05642 11KV05644 11KV05646 11KV05655 11LE27581 11LE27583 11KV05688 11KV05698 11KV05700 11LJ92554 11LJ92558 11LJ92559 11LJ92562 11LJ92568 11LJ92570 11LE27589 11LE27629 11LE27632 11LE27636 11LE27650 11LE27652 11LE27657 11LE27658 11LE27660 11LQ40040 11LQ40042 11LQ40045 11LQ40060 11LQ40064 11LE27809 11LE27813 11LE27814 11LE27816 11LE27826 11FK12725 11FK12728 11FK12729 11FK12750 11FK12752 11KV06146 11KV06210 11KV06213 11KV06215 11KV06221 ",".","80 units","Blood products, which were collected in a manner that may have compromised the sterility of the collection system, were distributed.",7/6/2005,"07/06/2005",5/15/2013,"05/15/2013"
"Biologics",40625,"Terminated","Community Blood Center of the Ozarks","Springfield","MO","US","Voluntary: Firm Initiated","Letter","MO","B-0930-13","Class II","Red Blood Cells","6576566",".","1 unit","Blood products, collected from a donor who traveled to a malarial endemic area, were distributed. ",8/22/2005,"08/22/2005",4/10/2013,"04/10/2013"
"Biologics",40625,"Terminated","Community Blood Center of the Ozarks","Springfield","MO","US","Voluntary: Firm Initiated","Letter","MO","B-0931-13","Class II","Red Blood Cells Leukocytes Reduced","6609847",".","1 unit","Blood products, collected from a donor who traveled to a malarial endemic area, were distributed. ",8/22/2005,"08/22/2005",4/10/2013,"04/10/2013"
"Biologics",40629,"Terminated","Community Blood Center of the Ozarks","Springfield","MO","US","Voluntary: Firm Initiated","Letter","MO","B-0357-13","Class II","Platelets Pheresis Leukocytes Reduced","9917207",,"1 unit","Blood product, which did not meet acceptable product specifications, was distributed.",8/23/2005,"08/23/2005",3/13/2013,"03/13/2013"
"Biologics",40646,"Terminated","BioLife Plasma Services L.P.","Independence","MO","US","Voluntary: Firm Initiated","Letter","CA","B-0933-13","Class II","Source Plasma","05IMOA0697; 05IMOA0914; 05IMOA1311; 05IMOA1588; 05IMOA2057; 05IMOA2312; 05IMOA2669; 05IMOA2996; 05IMOA3358; 05IMOA3582; 05IMOA4007; 05IMOA4251; 05IMOA4655; 05IMOA4877; 05IMOA5269; 05IMOA5536; 05IMOA5997; 05IMOA6209; 05IMOA6648; 05IMOA6944; 05IMOA7372; 05IMOA7650; 05IMOA8410; 05IMOA9490; 05IMOA9751; 05IMOB1163; 05IMOB2262; 05IMOB2549; 05IMOB3013; 05IMOB3290; 05IMOB3698; 05IMOB3976; 05IMOB4378; 05IMOB4683",".","34 units","Blood products, collected from a donor who received a piercing within 12 months of the donation, were distributed.",7/26/2005,"07/26/2005",4/24/2013,"04/24/2013"
"Biologics",40686,"Terminated","BioLife Plasma Services L.P.","Van Nuys","CA","US","Voluntary: Firm Initiated","E-Mail","California","B-0029-14","Class II","Source Plasma","05EWIA3253, 05OWIA2323, 04AIAE2883, 04FMOB2983, 04FMOB3477, 04FMOB3745",".","6 units","Blood products, which were not quarantined after receiving information regarding the suitability of the donors, were distributed.",8/15/2005,"08/15/2005",12/4/2013,"12/04/2013"
"Biologics",40694,"Terminated","Community Blood Center of the Ozarks","Springfield","MO","US","Voluntary: Firm Initiated","Letter","FL; MO; NJ; AR; Austria","B-1531-13","Class II","Red Blood Cells","6643888; 6643907; 6643885; 6643794; 6643796; 6643919 6643938; 6643936; 6643878; 6653781; 6643910; 6643915 6639466; 6653784; 6639424; 6639423; 6639449; 6634622; 6633512; 6639467; 6643284; 6634456; 6643307; 6629134; 6643778; 6643494; 6643646; 8913062; 6651719 ",".","29 Units","Blood Collection/Sterility compromised.",8/11/2005,"08/11/2005",7/10/2013,"07/10/2013"
"Biologics",40694,"Terminated","Community Blood Center of the Ozarks","Springfield","MO","US","Voluntary: Firm Initiated","Letter","FL; MO; NJ; AR; Austria","B-1533-13","Class II","Platelets","6633512; 6635965 ",".","2 units","Blood products, possibly contaminated with air, were distributed.",8/11/2005,"08/11/2005",7/10/2013,"07/10/2013"
"Biologics",40694,"Terminated","Community Blood Center of the Ozarks","Springfield","MO","US","Voluntary: Firm Initiated","Letter","FL; MO; NJ; AR; Austria","B-1535-13","Class II","Red Blood Cells Leukocytes Reduced","6654187; 6639454; 6644279; 6639388; 6639448; 6635965; 6643694; 6643690 ",".","8 units","Blood products, possibly contaminated with air, were distributed.",8/11/2005,"08/11/2005",7/10/2013,"07/10/2013"
"Biologics",40694,"Terminated","Community Blood Center of the Ozarks","Springfield","MO","US","Voluntary: Firm Initiated","Letter","FL; MO; NJ; AR; Austria","B-1532-13","Class II","Cryoprecipitated AHF","6634622; 6629134 ",".","2 units","Blood products, possibly contaminated with air, were distributed.",8/11/2005,"08/11/2005",7/10/2013,"07/10/2013"
"Biologics",40694,"Terminated","Community Blood Center of the Ozarks","Springfield","MO","US","Voluntary: Firm Initiated","Letter","FL; MO; NJ; AR; Austria","B-1534-13","Class II","Fresh Frozen Plasma","6633512; 6634456; 6635965 ",".","3 units","Blood products, possibly contaminated with air, were distributed.",8/11/2005,"08/11/2005",7/10/2013,"07/10/2013"
"Biologics",40709,"Terminated","Tri-Counties Blood Bank","Santa Barbara","CA","US","Voluntary: Firm Initiated","Letter","CA","B-2093-13","Class II","Platelets Pheresis Leukocytes Reduced ","GW70745; GW52751",,"2 units","Blood products, collected from a donor who was taking the medication Avodart (Dutasteride), were distributed.",9/9/2005,"09/09/2005",8/21/2013,"08/21/2013"
"Biologics",40709,"Terminated","Tri-Counties Blood Bank","Santa Barbara","CA","US","Voluntary: Firm Initiated","Letter","CA","B-2094-13","Class II","Platelets Pheresis Leukocytes Reduced Irradiated","GW70745; GW60775, GW52751",,"3 units","Blood products, collected from a donor who was taking the medication Avodart (Dutasteride), were distributed.",9/9/2005,"09/09/2005",8/21/2013,"08/21/2013"
"Biologics",40717,"Terminated","BioLife Plasma Services L.P.","Van Nuys","CA","US","Voluntary: Firm Initiated","Letter","CA","B-0028-14","Class II","Source Plasma","05MUSA0255",".","1 unit","Blood product, which was not quarantined after receiving information regarding the donor's history of incarceration, was distributed.",7/16/2007,"07/16/2007",12/4/2013,"12/04/2013"
"Biologics",40747,"Terminated","American National Red Cross (The)","West Henrietta","NY","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","New York, California","B-0569-13","Class III","Blood and Blood Products for Reprocessing","01GL85672",,"1 unit","Blood products, collected from a donor who was previously deferred, were distributed.",8/12/2005,"08/12/2005",2/20/2013,"02/20/2013"
"Biologics",40747,"Terminated","American National Red Cross (The)","West Henrietta","NY","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","New York, California","B-0568-13","Class II","Red Blood Cells","01GL85672",,"1 unit","Blood products, collected from a donor who was previously deferred, were distributed.",8/12/2005,"08/12/2005",2/20/2013,"02/20/2013"
"Biologics",40755,"Terminated","Northwest Florida Blood Center, Inc.","Pensacola","FL","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Florida","B-1314-13","Class III","Red Blood Cells Leukocytes Reduced Irradiated","4074426",".","1 unit","Blood product, which was not manufactured in accordance to acceptable product specifications, was distributed.",1/6/2005,"01/06/2005",6/5/2013,"06/05/2013"
"Biologics",40757,"Terminated","American National Red Cross (The)","Saint Louis","MO","US","Voluntary: Firm Initiated","Telephone","Nationwide (including MO, IL, PR, AR, SC, GA, TN, MI, AL, OK, TX)","B-1042-13","Class II","Platelets Pheresis Leukocytes Reduced Irradiated","11FM94276",".","1 unit","Blood products, collected from donors whose arm scrub may have been performed incorrectly, were distributed.",8/11/2005,"08/11/2005",5/1/2013,"05/01/2013"
"Biologics",40757,"Terminated","American National Red Cross (The)","Saint Louis","MO","US","Voluntary: Firm Initiated","Telephone","Nationwide (including MO, IL, PR, AR, SC, GA, TN, MI, AL, OK, TX)","B-1037-13","Class II","Platelets, Leukocytes Reduced","11FM94273, 11FM94274, 11FM94278, 11FM94279, 11FM94280, 11FM94281, 11FM94282, 11FM94284, 11FM94288, 11FM94295, 11FM96243, 11FM96248, 11FM96250, 11FM97437, 11FM97440, 11FM97443, 11FM97447, 11FM97465, 11FM97473, 11FM97475, 11FS32637, 11FS32639, 11FS32642, 11FS32644, 11FS32646, 11FS32651, 11FT12757, 11FT12759, 11FT12779, 11FW16250, 11FW16352, 11FW16353, 11FW16358, 11FW16361, 11FW16611, 11FW17436, 11FW17438, 11FW17441, 11FW17448, 11FW17451, 11FW17453, 11FW17455, 11FW18680, 11FW18687, 11FY24514, 11FY24516, 11FY24521, 11FY24526, 11FY24532, 11FY24533, 11FY24534, 11FY24535, 11FY24540, 11FY24544, 11FZ58073, 11FZ58083, 11FZ58087, 11FZ58089, 11FZ58092, 11FZ58095, 11FZ58103, 11FZ58104, 11FZ58108, 11FZ58927, 11FZ58931, 11FZ58936, 11FZ58943, 11FZ58973, 11FZ58985, 11FZ58988, 11FZ58989, 11FZ58991, 11FZ61171, 11FZ61173, 11FZ61177, 11FZ61179, 11FZ61184, 11FZ61327, 11FZ61330, 11FZ61343, 11FZ61345, 11FZ61346, 11FZ61349, 11FZ61350, 11FZ61355, 11GG33615, 11GG33617, 11GG33619, 11GG33622, 11GG33631, 11GG33637, 11GG33638, 11GG33652, 11GG33653, 11GG33832, 11GG33847, 11GG33849, 11GG33856, 11GG33861, 11GJ58516, 11GJ63167, 11GJ63168, 11GJ63173, 11GJ63190, 11GJ63193, 11GJ63196, 11GJ63198, 11GK75236, 11GK75240, 11GK75244, 11GK75247, 11GK75251, 11GK75254, 11GK75261, 11GK79417, 11GK79419, 11GK79420, 11GK79426, 11GK79427, 11GK79430, 11GK79432, 11GK79433, 11GK79435, 11GK79436, 11GK79438, 11GK79441, 11GK79442, 11GK79443, 11GK79448, 11GK79449, 11GM83012, 11GM83014, 11GM83017, 11GM83020, 11GM83023, 11GM83029, 11GM83059, 11GM83064, 11GM83065, 11GM83068, 11GM83069, 11GM83096, 11GN70818, 11GN70827, 11GN70838, 11GN70843, 11GN70847, 11GN70854, 11GN70862, 11GN72223, 11GN72230, 11GN72238, 11GN72269, 11GN72274, 11GN72279, 11GN72284, 11GN72292, 11GN72301, 11GN73053, 11GN73056, 11GN73058, 11GN73061, 11GN73063, 11GN76489, 11GN76493, 11GN76503, 11GN76507, 11GN76512, 11GN76513, 11GN76527, 11GR56963, 11GR56964, 11GR56968, 11GR56970, 11GR59573, 11GR59583, 11GR59586, 11GR59591, 11GR59594, 11GR59646, 11GR59648, 11GR59650, 11GR59664, 11GR59669, 11GS78508, 11GS78510,",".","215 units","Blood products, collected from donors whose arm scrub may have been performed incorrectly, were distributed.",8/11/2005,"08/11/2005",5/1/2013,"05/01/2013"
"Biologics",40757,"Terminated","American National Red Cross (The)","Saint Louis","MO","US","Voluntary: Firm Initiated","Telephone","Nationwide (including MO, IL, PR, AR, SC, GA, TN, MI, AL, OK, TX)","B-1035-13","Class II"," Plasma, Frozen ","11FM91561, 11FM93576, 11FM93581, 11FM94273, 11FM94274, 11FM94279, 11FM94280, 11FM94282, 11FM95400, 11FM95402, 11FM95404, 11FM95409, 11FM95410, 11FM97449, 11FS27703, 11FS27970, 11FS27998, 11FS27999, 11FS28002, 11FT12759, 11FW14665, 11FW16001, 11FW16611, 11FW18680, 11FW22112, 11FW22132, 11FW22135, 11FW22137, 11FW22141, 11FW22143, 11FW22155, 11FX00808, 11FZ58991, 11FZ61750, 11FZ67142, 11GG40617, 11GG40618, 11GG40621, 11GG40622, 11GJ58516, 11GJ58527, 11GJ67538, 11GL90606, 11GM81524, 11GM82611, 11GM83029, 11GM83053, 11GM84841, 11GM84842, 11GM84846, 11GM86361, 11GM86388, 11GM86389, 11GM86393, 11GM86394, 11GM86401, 11GM86403, 11GM86551, 11GM86552, 11GM87055, 11GM89059, 11GM90545, 11GM90548, 11GM90552, 11GN70818, 11GN70843, 11GN70847, 11GN70854, 11GN70862, 11GN71553, 11GN71556, 11GN71557, 11GN71559, 11GN71572, 11GN71575, 11GN71577, 11GN71578, 11GN71581, 11GN71583, 11GN71584, 11GN80669, 11GN80678, 11GN82023, 11GN82028, 11GN82029, 11GN82033, 11GN82047, 11GP15759, 11GQ70839, 11GQ70847, 11GR54865, 11GR56962, 11GR56963, 11GR56965, 11GR56968, 11GR56970, 11GR56979, 11GR58249, 11GR59646, 11GR63266, 11GR63301, 11GR63304, 11GR66957, 11GR66960, 11GS77556, 11GS77560, 11GS81640, 11GS81641, 11GS81645, 11GV61777, 11GV61783, 11GV68455, 11GY34096, 11GY34099, 11GY36744, 11KH02821, 11KH02824, 11KL07954, 11KN05127, 11KN05133, 11KN05156, 11KN05961, 11KN05969, 11KN05973, 11KN05962, 11GJ67548 ",".","126 units","Blood products, collected from donors whose arm scrub may have been performed incorrectly, were distributed.",8/11/2005,"08/11/2005",5/1/2013,"05/01/2013"
"Biologics",40757,"Terminated","American National Red Cross (The)","Saint Louis","MO","US","Voluntary: Firm Initiated","Telephone","Nationwide (including MO, IL, PR, AR, SC, GA, TN, MI, AL, OK, TX)","B-1032-13","Class II","Cryoprecipitated AHF","11FH01557, 11FH02075, 11FH02076, 11FH02097, 11FH02100, 11FH02131, 11FH02138, 11FH02141, 11FH02148, 11FH02149, 11FH02154, 11FH02943, 11FH02944, 11FH02950, 11FH03172, 11FH03601, 11FJ12078, 11FJ12079, 11FJ12349, 11FJ12381, 11FJ12429, 11FJ12495, 11FJ12498, 11FL23592, 11FL23594, 11FL23599, 11FL23600, 11FL23619, 11FL23621, 11FL23625, 11FL23627, 11FL23630, 11FL29150, 11FL29155, 11FL29156, 11FL29714, 11FL29716, 11FL29717, 11FL29719, 11FL29728, 11FL29730, 11FL29732, 11FL31966, 11FL31967, 11FL31968, 11FL31971, 11FL31973, 11FL31979, 11FL31980, 11FL31984, 11FL31986, 11FL31987, 11FM92804, 11FM92806, 11FM92808, 11FM93036, 11FM93038, 11FM93043, 11FM93044, 11FM93046, 11FM93047, 11FM93051, 11FM93055, 11FM93347, 11FM93348, 11FM93349, 11FM93351, 11FM93353, 11FM93354, 11FM93364, 11FM93366, 11FM93368, 11FM93381, 11FM96260, 11FM96261, 11FM96263, 11FM96292, 11FM96293, 11FM96304, 11FM96307, 11FM96747, 11FM96749, 11FM96758, 11FM96761, 11FM96764, 11FM96765, 11FM96767, 11FM96770, 11FM96771, 11FM96938, 11FM96940, 11FM96941, 11FM96942, 11FM96943, 11FM96945, 11FM96947, 11FM96948, 11FM96949, 11FM97672, 11FM97674, 11FM97675, 11FM97677, 11FM99246, 11FM99248, 11FM99249, 11FM99250, 11FR05111, 11FR05113, 11FR05114, 11FS29671, 11FS29673, 11FS29677, 11FS29681, 11FS29688, 11FS29689, 11FS29693, 11FS29694, 11FS30550, 11FS30552, 11FS30553, 11FS30558, 11FS30561, 11FS30567, 11FT12785, 11FT12786, 11FT12788, 11FT12797, 11FT12871, 11FT13056, 11FT13059, 11FT13293, 11FT13301, 11FW14468, 11FW14474, 11FW16527, 11FW16528, 11FW16541, 11FW16544, 11FW17392, 11FW17393, 11FW17395, 11FW17396, 11FW17399, 11FW17400, 11FW17403, 11FW17405, 11FW17408, 11FW17607, 11FW17620, 11FW17623, 11FW17623, 11FW17632, 11FW17648, 11FW17650, 11FW17659, 11FW17660, 11FW17665, 11FW17670, 11FW17674, 11FW18208, 11FW18218, 11FW18222, 11FW18224, 11FW18225, 11FW18227, 11FW18228, 11FW18279, 11FW18284, 11FW18287, 11FW18288, 11FW18291, 11FW20134, 11FW20136, 11FW20138, 11FW20149, 11FW20151, 11FW20862, 11FW20863, 11FW20865, 11FW20868, 11FW20869, 11FW20871, 11FW20873, 11FW20878, 11FW20884, 11FW21646,",".","748 units","Blood products, collected from donors whose arm scrub may have been performed incorrectly, were distributed.",8/11/2005,"08/11/2005",5/1/2013,"05/01/2013"
"Biologics",40757,"Terminated","American National Red Cross (The)","Saint Louis","MO","US","Voluntary: Firm Initiated","Telephone","Nationwide (including MO, IL, PR, AR, SC, GA, TN, MI, AL, OK, TX)","B-1040-13","Class II","Red Blood Cells (Apheresis) Leukocytes Reduced","11GN70827, 11FW16349, 11FW16353, 11FW16358, 11FW16361, 11FW16619, 11FY24514, 11FY24516, 11FY24521, 11FY24526, 11FY24532, 11FY24533, 11FY24534, 11FY24535, 11FY24540, 11FY24541, 11FY24544, 11GJ58516, 11GJ58527, 11GJ58548, 11GS78517, 11GS78508, 11GS78510, 11GS78530, 11GS78536, 11GS78538, 11GS78539, 11GS78544, 11GS78549, 11GS78552, 11GN73053, 11GN73056, 11GN73058, 11GN73061, 11GN73063, 11GN73086, 11GR56962, 11GR56963, 11GR56964, 11GR56965, 11GR56968, 11GR56970, 11GR56979, 11GS78652, 11GS78657, 11GS78665, 11GS78676, 11GS78677, 11GS78682, 11GS78711, 11GS78716, 11FZ58927, 11FZ58931, 11FZ58936, 11FZ58973, 11FZ58985, 11FZ58988, 11FZ58989, 11FZ58991, 11GY34414, 11FW17436, 11FW17438, 11FW17441, 11FW17448, 11FW17451, 11FW17453, 11FW17455, 11FZ61171, 11FZ61173, 11FZ61177, 11FZ61179, 11FZ61184, 11FZ61327, 11FZ61330, 11FZ61343, 11FZ61344, 11FZ61345, 11FZ61346, 11FZ61349, 11FZ61350, 11FZ61355, 11FS32639, 11FS32642, 11FS32646, 11FS32647, 11FS32651 ",".","86 units","Blood products, collected from donors whose arm scrub may have been performed incorrectly, were distributed.",8/11/2005,"08/11/2005",5/1/2013,"05/01/2013"
"Biologics",40757,"Terminated","American National Red Cross (The)","Saint Louis","MO","US","Voluntary: Firm Initiated","Telephone","Nationwide (including MO, IL, PR, AR, SC, GA, TN, MI, AL, OK, TX)","B-1033-13","Class II","Red Blood Cells","11FH00941, 11FH00942, 11FH00958, 11FH00961, 11FH00963, 11FH01213, 11FH02944, 11FH02950, 11FJ11240, 11FL30632, 11FL30634, 11FL33217, 11FL33235, 11FM92804, 11FM92806, 11FM92808, 11FM93604, 11FM95400, 11FM95402, 11FM95404, 11FM95410, 11FR05111, 11FR05113, 11FR05114, 11FR07069, 11FR07071, 11FS27705, 11FS27718, 11FS27719, 11FS27998, 11FS29671, 11FS29673, 11FS29676, 11FS29677, 11FS29681, 11FS29686, 11FS29688, 11FS29689, 11FS29693, 11FS29694, 11FS30559, 11FS30561, 11FS35187, 11FT12785, 11FT12786, 11FT12788, 11FT12797, 11FT12871, 11FW14474, 11FW14775, 11FW15654, 11FW15658, 11FW15662, 11FW15664, 11FW15666, 11FW15672, 11FW15674, 11FW15675, 11FW15676, 11FW15678, 11FW15679, 11FW16001, 11FW16013, 11FW16022, 11FW16035, 11FW16037, 11FW16058, 11FW16061, 11FW16068, 11FW16364, 11FW16544, 11FW16585, 11FW16594, 11FW16845, 11FW17648, 11FW17650, 11FW17659, 11FW17665, 11FW17670, 11FW17674, 11FW18284, 11FW18287, 11FW18288, 11FW18291, 11FW20171, 11FW20178, 11FW20183, 11FW20184, 11FW20230, 11FW20233, 11FW20234, 11FW20237, 11FW20239, 11FW20240, 11FW20241, 11FW20242, 11FW20244, 11FW20251, 11FW20254, 11FW21557, 11FW21558, 11FW21564, 11FW22111, 11FW22113, 11FW22115, 11FW22117, 11FW22118, 11FW22139, 11FW22331, 11FW23293, 11FW23295, 11FW23320, 11FX00828, 11FY25657, 11FY25665, 11FY25667, 11FY25674, 11FY25676, 11FY25678, 11FY25680, 11FY28128, 11FZ57250, 11FZ57252, 11FZ57275, 11FZ59018, 11FZ61033, 11FZ61035, 11FZ61041, 11FZ64195, 11FZ64234, 11FZ64288, 11FZ64300, 11FZ64310, 11GE83543, 11GE83545, 11GE83547, 11GE83548, 11GE83551, 11GE83552, 11GE83553, 11GE83555, 11GE85359, 11GE86387, 11GE86388, 11GE86398, 11GE86405, 11GE86418, 11GE88600, 11GE88601, 11GE88603, 11GE88606, 11GE88617, 11GE88619, 11GG41970, 11GJ65579, 11GJ65608, 11GJ65638, 11GJ65646, 11GJ65651, 11GJ65657, 11GJ66878, 11GJ66880, 11GJ66883, 11GJ66898, 11GK73704, 11GK75262, 11GK75316, 11GK75321, 11GK76602, 11GK76605, 11GK76606, 11GK76616, 11GL89316, 11GM79530, 11GM79538, 11GM79542, 11GM79610, 11GM79616, 11GM79618, 11GM79625, 11GM79632, 11GM79641, 11GM79644, 11GM79665, 11GM80578, 11GM82604,",".","300 units","Blood products, collected from donors whose arm scrub may have been performed incorrectly, were distributed.",8/11/2005,"08/11/2005",5/1/2013,"05/01/2013"
"Biologics",40757,"Terminated","American National Red Cross (The)","Saint Louis","MO","US","Voluntary: Firm Initiated","Telephone","Nationwide (including MO, IL, PR, AR, SC, GA, TN, MI, AL, OK, TX)","B-1036-13","Class II","Red Blood Cells, Leukoreduced, Irradiated","11FH02134, 11FL31973, 11FM93372, 11FM96945, 11FT13056, 11FW18201, 11FW23191, 11FW25678, 11FX00653, 11FX00673, 11FX00715, 11FZ65047, 11GG37388, 11GJ63708, 11GJ63709, 11GJ65929, 11GJ66619, 11GL89288, 11GL89293, 11GL89310, 11GM87065, 11GM87075, 11GN81474, 11GN81483, 11GN81490, 11GN81749, 11GR68108, 11GV68442, 11GY35394, 11GY37185, 11KF17048, 11KN06816, 11GN77230 ",".","33 units","Blood products, collected from donors whose arm scrub may have been performed incorrectly, were distributed.",8/11/2005,"08/11/2005",5/1/2013,"05/01/2013"
"Biologics",40757,"Terminated","American National Red Cross (The)","Saint Louis","MO","US","Voluntary: Firm Initiated","Telephone","Nationwide (including MO, IL, PR, AR, SC, GA, TN, MI, AL, OK, TX)","B-1041-13","Class II","Red Blood Cells Frozen","11GN71033",".","1 unit","Blood products, collected from donors whose arm scrub may have been performed incorrectly, were distributed.",8/11/2005,"08/11/2005",5/1/2013,"05/01/2013"
"Biologics",40757,"Terminated","American National Red Cross (The)","Saint Louis","MO","US","Voluntary: Firm Initiated","Telephone","Nationwide (including MO, IL, PR, AR, SC, GA, TN, MI, AL, OK, TX)","B-1034-13","Class II","Fresh Frozen Plasma","11FH00941, 11FH00942, 11FH00955, 11FH00958, 11FH00961, 11FH00963, 11FH01346, 11FH01868, 11FH01869, 11FH01876, 11FH01877, 11FH01878, 11FH03712, 11FJ10894, 11FJ10969, 11FJ11726, 11FL31438, 11FL31441, 11FL31442, 11FL31444, 11FL31448, 11FM93604, 11FM94288, 11FM94295, 11FM94301, 11FM95390, 11FM95940, 11FM95942, 11FM95943, 11FM95946, 11FM95948, 11FM95949, 11FM96243, 11FM96248, 11FM96250, 11FM97437, 11FM97440, 11FM97443, 11FM97447, 11FM97465, 11FM97473, 11FM97475, 11FM97742, 11FM97756, 11FM97757, 11FM97760, 11FM97995, 11FM97997, 11FM98001, 11FM98015, 11FM99410, 11FM99414, 11FM99685, 11FM99686, 11FM99692, 11FM99694, 11FM99698, 11FM99699, 11FM99700, 11FS27705, 11FS27718, 11FS27719, 11FS28052, 11FS32238, 11FS32239, 11FS32244, 11FS32639, 11FS32642, 11FS32644, 11FS32651, 11FS35184, 11FS35187, 11FS35197, 11FT12763, 11FT12779, 11FW14604, 11FW14608, 11FW14690, 11FW14700, 11FW14701, 11FW14705, 11FW14708, 11FW14717, 11FW14775, 11FW14862, 11FW15543, 11FW15551, 11FW15563, 11FW15601, 11FW15615, 11FW15628, 11FW15638, 11FW15657, 11FW15658, 11FW15662, 11FW15664, 11FW15666, 11FW15672, 11FW15674, 11FW15675, 11FW15676, 11FW15678, 11FW15679, 11FW15682, 11FW16022, 11FW16035, 11FW16037, 11FW16058, 11FW16061, 11FW16065, 11FW16068, 11FW16073, 11FW16074, 11FW16250, 11FW16257, 11FW16352, 11FW16353, 11FW16358, 11FW16361, 11FW16659, 11FW17436, 11FW17448, 11FW17451, 11FW17453, 11FW17455, 11FW18293, 11FW18687, 11FW20230, 11FW20234, 11FW20239, 11FW20240, 11FW20241, 11FW20242, 11FW20244, 11FW20251, 11FW20254, 11FW20794, 11FW20795, 11FW20797, 11FW20808, 11FW20809, 11FW21450, 11FW21454, 11FW21548, 11FW21557, 11FW21558, 11FW21564, 11FW21678, 11FW23320, 11FW25174, 11FW25175, 11FW25177, 11FX00432, 11FX00655, 11FX00671, 11FX00675, 11FX00685, 11FX00699, 11FX00702, 11FX00705, 11FX00709, 11FX00710, 11FX00713, 11FX00716, 11FX00718, 11FX00719, 11FX00810, 11FX00813, 11FX00828, 11FY24514, 11FY24516, 11FY24521, 11FY24526, 11FY24532, 11FY24533, 11FY24534, 11FY24540, 11FY24544, 11FY26625, 11FY26627, 11FY26630, 11FY29571, 11FY29589, 11FZ57275, 11FZ57277, 11FZ57284,",".","620 units","Blood products, collected from donors whose arm scrub may have been performed incorrectly, were distributed.",8/11/2005,"08/11/2005",5/1/2013,"05/01/2013"
"Biologics",40757,"Terminated","American National Red Cross (The)","Saint Louis","MO","US","Voluntary: Firm Initiated","Telephone","Nationwide (including MO, IL, PR, AR, SC, GA, TN, MI, AL, OK, TX)","B-1031-13","Class II","Red Blood Cells Leukocytes Reduced","11FH01099, 11FH01108, 11FH01111, 11FH01123, 11FH01199, 11FH01346, 11FH01557, 11FH01867, 11FH01868, 11FH01869, 11FH01876, 11FH01877, 11FH01878, 11FH02075, 11FH02076, 11FH02085, 11FH02097, 11FH02100, 11FH02131, 11FH02138, 11FH02141, 11FH02148, 11FH02149, 11FH02154, 11FH03172, 11FH03601, 11FH03609, 11FH03712, 11FH03714, 11FH03723, 11FJ10087, 11FJ10110, 11FJ10250, 11FJ10355, 11FJ10451, 11FJ10504, 11FJ10537, 11FJ10570, 11FJ10894, 11FJ10969, 11FJ11026, 11FJ11488, 11FJ11646, 11FJ11779, 11FJ11815, 11FJ12078, 11FJ12079, 11FJ12349, 11FJ12381, 11FJ12495, 11FJ12498, 11FK06804, 11FK06844, 11FL23592, 11FL23594, 11FL23599, 11FL23600, 11FL23619, 11FL23621, 11FL23625, 11FL23627, 11FL23630, 11FL25145, 11FL29150, 11FL29155, 11FL29156, 11FL29714, 11FL29716, 11FL29717, 11FL29719, 11FL29728, 11FL29730, 11FL29732, 11FL31438, 11FL31441, 11FL31442, 11FL31444, 11FL31448, 11FL31966, 11FL31967, 11FL31968, 11FL31971, 11FL31979, 11FL31980, 11FL31983, 11FL31984, 11FL31986, 11FL33208, 11FL33211, 11FL33213, 11FL33214, 11FL33218, 11FL33239, 11FL33241, 11FM91579, 11FM93036, 11FM93038, 11FM93043, 11FM93044, 11FM93046, 11FM93047, 11FM93051, 11FM93055, 11FM93347, 11FM93348, 11FM93349, 11FM93351, 11FM93353, 11FM93354, 11FM93364, 11FM93366, 11FM93368, 11FM93370, 11FM93381, 11FM93576, 11FM93581, 11FM94273, 11FM94274, 11FM94276, 11FM94277, 11FM94278, 11FM94279, 11FM94280, 11FM94282, 11FM94284, 11FM94287, 11FM94288, 11FM94295, 11FM94301, 11FM95390, 11FM95940, 11FM95942, 11FM95946, 11FM95948, 11FM95949, 11FM96243, 11FM96248, 11FM96250, 11FM96260, 11FM96261, 11FM96263, 11FM96268, 11FM96292, 11FM96293, 11FM96304, 11FM96307, 11FM96747, 11FM96749, 11FM96758, 11FM96761, 11FM96764, 11FM96765, 11FM96767, 11FM96770, 11FM96771, 11FM96938, 11FM96940, 11FM96941, 11FM96942, 11FM96943, 11FM96947, 11FM96948, 11FM96949, 11FM97437, 11FM97440, 11FM97443, 11FM97447, 11FM97449, 11FM97465, 11FM97473, 11FM97475, 11FM97674, 11FM97675, 11FM97740, 11FM97741, 11FM97742, 11FM97756, 11FM97757, 11FM97995, 11FM97997, 11FM98015, 11FM99246, 11FM99248, 11FM99249, 11FM99250, 11FM99406,",".","1647 units","Blood products, collected from donors whose arm scrub may have been performed incorrectly, were distributed.",8/11/2005,"08/11/2005",5/1/2013,"05/01/2013"
"Biologics",40757,"Terminated","American National Red Cross (The)","Saint Louis","MO","US","Voluntary: Firm Initiated","Telephone","Nationwide (including MO, IL, PR, AR, SC, GA, TN, MI, AL, OK, TX)","B-1039-13","Class II","Red Blood Cells (Apheresis) Leukocytes Reduced Irradiated","11GS76560, 11GS76565, 11GN70854, 11GN72274, 11FW16352, 11FW16611, 11GS78518, 11GN73060, 11FM94281, 11FS32644, 11GK79417 ",".","11 units","Blood products, collected from donors whose arm scrub may have been performed incorrectly, were distributed.",8/11/2005,"08/11/2005",5/1/2013,"05/01/2013"
"Biologics",40757,"Terminated","American National Red Cross (The)","Saint Louis","MO","US","Voluntary: Firm Initiated","Telephone","Nationwide (including MO, IL, PR, AR, SC, GA, TN, MI, AL, OK, TX)","B-1038-13","Class II","Plasma Frozen, Cryoprecipitate Reduced","11FH03172, 11FJ12429, 11FJ12495, 11FL23592, 11FL23594, 11FL23599, 11FL23600, 11FL23619, 11FL23625, 11FL23630, 11FL29155, 11FL29156, 11FM92804, 11FM92806, 11FM92808, 11FM93036, 11FM93051, 11FM93347, 11FM93348, 11FM93349, 11FM93351, 11FM93353, 11FM93354, 11FM93364, 11FM93366, 11FM93368, 11FM93381, 11FM96260, 11FM96261, 11FM96263, 11FM96292, 11FM96293, 11FM96304, 11FM96307, 11FM96747, 11FM96749, 11FM96758, 11FM96761, 11FM96764, 11FM96765, 11FM96767, 11FM96770, 11FM96771, 11FM96938, 11FM96940, 11FM96941, 11FM96942, 11FM96943, 11FM96945, 11FM96947, 11FM96948, 11FM96949, 11FM97675, 11FM99246, 11FM99249, 11FM99250, 11FS29671, 11FS29673, 11FS29694, 11FS30550, 11FS30561, 11FT12785, 11FT12786, 11FT12788, 11FT12797, 11FT13056, 11FT13059, 11FW20134, 11FW20136, 11FW20138, 11FW20149, 11FW20151, 11FW20862, 11FW20863, 11FW20865, 11FW20868, 11FW20869, 11FW20871, 11FW20873, 11FW20878, 11FW20884, 11FW21646, 11FW21649, 11FW21651, 11FW21655, 11FW21656, 11FW21658, 11FW21669, 11FW22338, 11FW22342, 11FW22346, 11FW23192, 11FW23198, 11FW23934, 11FW23955, 11FW24797, 11FW24812, 11FW24910, 11FW24920, 11FY27221, 11FY27491, 11FY27497, 11FY27673, 11FY28154, 11FY28577, 11FY28601, 11FY28822, 11FZ57884, 11FZ57890, 11FZ57898, 11FZ57905, 11FZ57907, 11FZ57915, 11FZ57918, 11FZ57919, 11FZ57925, 11FZ57926, 11FZ58608, 11FZ58613, 11FZ58616, 11FZ58617, 11FZ59018, 11FZ60026, 11FZ60032, 11FZ60130, 11FZ60144, 11FZ60146, 11FZ61253, 11FZ61255, 11FZ61256, 11FZ61258, 11FZ61260, 11FZ61261, 11FZ62278, 11FZ62279, 11FZ62720, 11FZ62721, 11FZ62723, 11FZ62727, 11FZ62730, 11FZ62734, 11FZ62735, 11FZ62737, 11FZ62739, 11FZ62775, 11FZ65012, 11FZ65405, 11FZ65416, 11FZ65553, 11FZ65572, 11GC70414, 11GC70420, 11GC70434, 11GC70435, 11GC70437, 11GJ65903, 11GJ65909, 11GJ65911, 11GJ65914, 11GJ65928, 11GK75166, 11GK75167, 11GK75179, 11GK75183, 11GK75184, 11GK75190, 11GK78073, 11GK78079, 11GK78089, 11GK80658, 11GK80659, 11GK80662, 11GK80663, 11GK80665, 11GK84982, 11GL89321, 11GM79197, 11GM79200, 11GM79204, 11GM79278, 11GM80577, 11GM80578, 11GM80580, 11GM80583, 11GM80955, 11GM80964,",".","267 units","Blood products, collected from donors whose arm scrub may have been performed incorrectly, were distributed.",8/11/2005,"08/11/2005",5/1/2013,"05/01/2013"
"Biologics",40759,"Terminated","American National Red Cross (The)","Saint Louis","MO","US","Voluntary: Firm Initiated","Telephone","MO","B-0411-13","Class III","Platelets Pheresis Leukocytes Reduced","011LS38060 ",,"1 unit","Blood product, for which Collection/Aperesis device was not used within acceptable time period, was distributed.",8/16/2005,"08/16/2005",2/20/2013,"02/20/2013"
"Biologics",40763,"Terminated","Blood Systems, Inc.","Ventura","CA","US","Voluntary: Firm Initiated","Letter","CA","B-0039-14","Class II","Platelets Pheresis","368520428",,"1","Blood product, which did not meet the acceptable product specifications, was distributed.",8/14/2005,"08/14/2005",12/18/2013,"12/18/2013"
"Biologics",40784,"Terminated","American National Red Cross (The)","Saint Louis","MO","US","Voluntary: Firm Initiated","Telephone","MO, AR, PR, SC, TN","B-0247-13","Class III","Red Blood Cells Leukocytes Reduced collected on 5/31/2005","11GS85442, 11GS85444, 11GS85445, 11GS85446, 11GS85447, 11GS85448, 11GS85449",,"7 UNITS","Blood products, collected using equipment for which quality control was not performed, were distributed.",9/13/2005,"09/13/2005",2/20/2013,"02/20/2013"
"Biologics",40787,"Terminated","HemaCare Corporation","Sherman Oaks","CA","US","Voluntary: Firm Initiated","Letter","California","B-1787-13","Class II","Red Blood Cells Leukocytes Reduced","4067666",".","1 unit","Blood products, which were collected from a donor who traveled to a malarial endemic area, were distributed.",9/30/2005,"09/30/2005",8/28/2013,"08/28/2013"
"Biologics",40790,"Terminated","Hemacare Corporation","Van Nuys","CA","US","Voluntary: Firm Initiated","Letter","CA","B-2556-13","Class II","Red Blood Cells Leukocytes Reduced","4040359",".","1 unit","Blood product, collected from a donor who traveled to an area considered endemic for malaria, was distributed.",8/5/2005,"08/05/2005",11/20/2013,"11/20/2013"
"Biologics",40807,"Terminated","Tri-counties Blood Bank","San Luis Obispo","CA","US","Voluntary: Firm Initiated","Letter","California","B-1833-13","Class II","Red Blood Cells Leukocytes Reduced","GW70580",,"1 unit","Blood product, positive for the c-antigen but labeled as c-antigen negative, was distributed. ",8/17/2005,"08/17/2005",7/31/2013,"07/31/2013"
"Biologics",40843,"Terminated","Mississippi Valley Reg Bld Ctr","Davenport","IA","US","Voluntary: Firm Initiated","Telephone","New York","B-0494-13","Class III","Red Blood Cells Leukocytes Reduced","C72367",".","1 Unit","Blood product, which did not have the correct amount red cell preservative solution added, was distributed. ",9/28/2005,"09/28/2005",2/6/2013,"02/06/2013"
"Biologics",40856,"Terminated","Mississippi Valley Reg Bld Ctr","Davenport","IA","US","Voluntary: Firm Initiated","FAX","Switzerland.","B-0543-13","Class II","Blood and Blood Products for Reprocessing","C71385",,"1 Unit","Blood product, collected from a donor with non-confirmed repeat reactive HBsAg, was distributed..",9/22/2005,"09/22/2005",3/6/2013,"03/06/2013"
"Biologics",40882,"Terminated","American National Red Cross (The)","Salt Lake City","UT","US","Voluntary: Firm Initiated","FAX","Idaho.","B-0773-13","Class II","Red Blood Cells Leukocytes Reduced","020LY57772",,"1 unit","Blood product, which was collected from a donor who traveled to a malarial endemic area, was distributed.",9/9/2005,"09/09/2005",4/3/2013,"04/03/2013"
"Biologics",40888,"Terminated","American National Red Cross (The)","Pomona","CA","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","California","B-1471-13","Class II","Platelets Pheresis Leukocytes Reduced","06KG42964, 06KG42855, 06KG42633, 06KG42531",,"4 units","Blood products, collected from a donor who traveled to an area considered endemic for malaria, were distributed.",8/29/2005,"08/29/2005",6/26/2013,"06/26/2013"
"Biologics",40892,"Terminated","DCI Biologicals LLC","Farmington","NM","US","Voluntary: Firm Initiated","E-Mail","England","B-0820-13","Class II","Source Plasma","FD0404494; FD0405248",,"2 units","Blood products, which tested reactive to HIV 1/2 and staff failed to quarantine units due to medical history, were distributed.",9/30/2005,"09/30/2005",4/3/2013,"04/03/2013"
"Biologics",40903,"Terminated","American National Red Cross (The)","Portland","OR","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Oregon and California","B-0230-13","Class II","Blood and Blood Products for Reprocessing","21FS42335",".","1 unit","Blood products, collected from a donor with a history of Hepatitis A, were distributed. ",9/22/2005,"09/22/2005",1/2/2013,"01/02/2013"
"Biologics",40903,"Terminated","American National Red Cross (The)","Portland","OR","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Oregon and California","B-0229-13","Class II","Red Blood Cells Leukocytes Reduced","21FS42335",".","1 unit","Blood products, collected from a donor with a history of Hepatitis A, were distributed. ",9/22/2005,"09/22/2005",1/2/2013,"01/02/2013"
"Biologics",40906,"Terminated","American National Red Cross (The)","Pomona","CA","US","Voluntary: Firm Initiated","Telephone","CA","B-2492-13","Class II","Red Blood Cells Leukocytes Reduced","06GK20836",,"1 unit","Blood products, collected from a donor for whom donor suitability was not adequately determined, were distributed.",9/22/2005,"09/22/2005",11/6/2013,"11/06/2013"
"Biologics",40906,"Terminated","American National Red Cross (The)","Pomona","CA","US","Voluntary: Firm Initiated","Telephone","CA","B-2492-13","Class II","Recovered Plasma","06GK20836",,"1 unit","Blood products, collected from a donor for whom donor suitability was not adequately determined, were distributed.",9/22/2005,"09/22/2005",11/6/2013,"11/06/2013"
"Biologics",40906,"Terminated","American National Red Cross (The)","Pomona","CA","US","Voluntary: Firm Initiated","Telephone","CA","B-2493-13","Class III","Recovered Plasma","06GK20836",,"1 unit","Blood products, collected from a donor for whom donor suitability was not adequately determined, were distributed.",9/22/2005,"09/22/2005",11/6/2013,"11/06/2013"
"Biologics",40953,"Terminated","American Red Cross Blood Services","Saint Louis","MO","US","Voluntary: Firm Initiated","Telephone","Missouri","B-0623-13","Class II","Cryoprecipitated AHF","11GY34917",,"1 Unit","Blood product, collected from a donor whose suitability to donate was not adequately determined, was distributed.",10/4/2005,"10/04/2005",4/17/2013,"04/17/2013"
"Biologics",40977,"Terminated","BioLife Plasma Services L.P.","Cedar Rapids","IA","US","Voluntary: Firm Initiated","FAX","Austria","B-1201-13","Class II","Source Plasma","05CIAE5431, 05CIAF0080",".","2 units","Blood products, which were not quarantined after receiving post donation information concerning prior incarceration, were distributed.",10/20/2005,"10/20/2005",5/1/2013,"05/01/2013"
"Biologics",40981,"Terminated","Northwest Florida Blood Center, Inc.","Pensacola","FL","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Alabama","B-0836-13","Class III","Platelets Pheresis","4079047",,"1 unit","Blood product, for which storage condition was outside the acceptable range, was distributed.",9/27/2005,"09/27/2005",4/17/2013,"04/17/2013"
"Biologics",40983,"Terminated","Northwest Florida Blood Center, Inc.","Pensacola","FL","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","FL, MS, AL","B-1742-13","Class II","Platelets Pheresis Leukocytes Reduced","4081978; 4081995",,"2 units","Blood products, labeled as leukoreduced, but were not properly verified by White Blood Cell count, were distributed.",9/8/2005,"09/08/2005",8/21/2013,"08/21/2013"
"Biologics",40983,"Terminated","Northwest Florida Blood Center, Inc.","Pensacola","FL","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","FL, MS, AL","B-1741-13","Class II","Platelets Pheresis","4082256(B); 4082292(A); 4082292(B); 4082311; 4082341(A); 4082341(B); 4082349; 4082361; 4082366(A); 4082374; 4082403(B); 4082423; 4082444(A); 4082444(B)",,"14 units","Blood products, labeled as leukoreduced, but were not properly verified by White Blood Cell count, were distributed.",9/8/2005,"09/08/2005",8/21/2013,"08/21/2013"
"Biologics",40983,"Terminated","Northwest Florida Blood Center, Inc.","Pensacola","FL","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","FL, MS, AL","B-1740-13","Class II","Platelets Pheresis Leukocytes Reduced Irradiated","4082244; 4082256(A); 4082319(B); 4082319; 4082366(B); 4082403(A).",,"6 units","Blood products, labeled as leukoreduced, but were not properly verified by White Blood Cell count, were distributed.",9/8/2005,"09/08/2005",8/21/2013,"08/21/2013"
"Biologics",40989,"Terminated","LifeServe Blood Center","Des Moines","IA","US","Voluntary: Firm Initiated","Letter","Iowa","B-0699-13","Class II","Red Blood Cells","KW94520; KW92744; KW90445",,"3 Units","Blood products, collected from a donor who was in close contact with an individual diagnosed with viral hepatitis, were distributed.",10/12/2005,"10/12/2005",3/20/2013,"03/20/2013"
"Biologics",40989,"Terminated","LifeServe Blood Center","Des Moines","IA","US","Voluntary: Firm Initiated","Letter","Iowa","B-0700-13","Class II","Fresh Frozen Plasma","KW88673",,"1 Unit","Blood products, collected from a donor who was in close contact with an individual diagnosed with viral hepatitis, were distributed.",10/12/2005,"10/12/2005",3/20/2013,"03/20/2013"
"Biologics",40989,"Terminated","LifeServe Blood Center","Des Moines","IA","US","Voluntary: Firm Initiated","Letter","Iowa","B-0701-13","Class II","Red Blood Cells Leukocytes Reduced","KW88673",,"1 Unit","Blood products, collected from a donor who was in close contact with an individual diagnosed with viral hepatitis, were distributed.",10/12/2005,"10/12/2005",3/20/2013,"03/20/2013"
"Biologics",40989,"Terminated","LifeServe Blood Center","Des Moines","IA","US","Voluntary: Firm Initiated","Letter","Iowa","B-0702-13","Class II","Platelets Irradiated","KW88673",,"1 Unit","Blood products, collected from a donor who was in close contact with an individual diagnosed with viral hepatitis, were distributed.",10/12/2005,"10/12/2005",3/20/2013,"03/20/2013"
"Biologics",41001,"Terminated","Atlanta Blood Services","Atlanta","GA","US","Voluntary: Firm Initiated","Letter","GA","B-1336-13","Class III","Platelets Leukocytes Reduced","8464482- A, 8464482- B",".","2","Blood products, collected from a donor whose temperature was not documented, were distributed.",10/6/2005,"10/06/2005",6/5/2013,"06/05/2013"
"Biologics",41019,"Terminated","San Diego Blood Bank","San Diego","CA","US","Voluntary: Firm Initiated","E-Mail","CA","B-2149-13","Class III","Red Blood Cells (Apheresis)","GJ23410",,"1 unit","Blood products, leukoreduced more than five days after collection, were distributed.",11/10/2005,"11/10/2005",8/21/2013,"08/21/2013"
"Biologics",41019,"Terminated","San Diego Blood Bank","San Diego","CA","US","Voluntary: Firm Initiated","E-Mail","CA","B-2150-13","Class III","Red Blood Cells Leukocytes Reduced","FM38468; KW69582",,"2 unit","Blood products, leukoreduced more than five days after collection, were distributed.",11/10/2005,"11/10/2005",8/21/2013,"08/21/2013"
"Biologics",41029,"Terminated","American Red Cross Blood Services","Omaha","NE","US","Voluntary: Firm Initiated","Telephone","NE,CA","B-1283-13","Class II","Red Blood Cells Leukocytes Reduced","09GX44561",".","1 Unit","Blood products, collected from a donor who traveled to a malaria endemic area, were distributed.",9/30/2005,"09/30/2005",7/10/2013,"07/10/2013"
"Biologics",41034,"Terminated","American Red Cross Blood Services","Wichita","KS","US","Voluntary: Firm Initiated","Telephone","Kansas","B-0826-13","Class III","Platelets Pheresis Leukocytes Reduced","21KP50423",,"1 Unit","Blood product, which shipment exceeded time allowed for shipping, was distributed.",10/12/2005,"10/12/2005",4/3/2013,"04/03/2013"
"Biologics",41049,"Terminated","American Red Cross Blood Services","Saint Louis","MO","US","Voluntary: Firm Initiated","Telephone","Missouri","B-0622-13","Class II","Red Blood Cells Leukocytes Reduced","11FR07265",,"1 Unit","Blood product, which was entered negative in the computer for K, Fya and Fyb antigen when tested turned out to be positive, was distributed. ",10/28/2005,"10/28/2005",3/20/2013,"03/20/2013"
"Biologics",41051,"Terminated","American Red Cross Blood Services","Saint Louis","MO","US","Voluntary: Firm Initiated","Telephone","Missouri","B-2298-13","Class II","Red Blood Cells Leukocytes Reduced","11GC73265",,"1 unit","Blood product, incorrectly labeled as negative for the Jka red cell antigen, was distributed.",10/27/2005,"10/27/2005",9/25/2013,"09/25/2013"
"Biologics",41055,"Terminated","Mississippi Valley Reg Bld Ctr","Davenport","IA","US","Voluntary: Firm Initiated","Telephone","Iowa","B-0493-13","Class II","Red Blood Cells Leukocytes Reduced","C72530",,"1 Unit","Blood product, which tested as CMV positive but labeled as CMV negative, was distributed.",10/6/2005,"10/06/2005",3/6/2013,"03/06/2013"
"Biologics",41059,"Terminated","Community Blood Center of the Ozarks","Springfield","MO","US","Voluntary: Firm Initiated","Letter","MO; Switzerland","B-0936-13","Class II","Red Blood Cells","6290021; 6336038",".","2 units","Blood products, collected from a donor whose suitability to donate was not adequately determined, were distributed.",11/2/2005,"11/02/2005",4/10/2013,"04/10/2013"
"Biologics",41059,"Terminated","Community Blood Center of the Ozarks","Springfield","MO","US","Voluntary: Firm Initiated","Letter","MO; Switzerland","B-0937-13","Class II","Blood and Blood Products for Reprocessing","6336038; 6290021",".","2 units","Blood products, collected from a donor whose suitability to donate was not adequately determined, were distributed.",11/2/2005,"11/02/2005",4/10/2013,"04/10/2013"
"Biologics",41078,"Terminated","Blood Systems, Inc.","Ventura","CA","US","Voluntary: Firm Initiated","Telephone","CA.","B-2567-13","Class II","Platelets Pheresis Leukocytes Reduced","368525147",,"1","Blood product, inappropriately stored in one platelet bag instead of two, was distributed.",10/10/2005,"10/10/2005",11/27/2013,"11/27/2013"
"Biologics",41085,"Terminated","Northwest Florida Blood Center, Inc.","Pensacola","FL","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Florida","B-0837-13","Class III","Platelets Leukocytes Reduced Irradiated","4920778(B); 4920778(A).",,"2 units","Blood products, prepared without the appropriate amount of additive added and/or incorrectly added, were distributed. ",10/22/2005,"10/22/2005",4/17/2013,"04/17/2013"
"Biologics",41089,"Terminated","Tri-counties Blood Bank","Phoenix","AZ","US","Voluntary: Firm Initiated","Letter","CA","B-1834-13","Class II","Red Blood Cells Leukocytes Reduced","LG82166; GX06220",,"2 units","Blood products, which were collected from a donor who traveled to a malarial endemic area, were distributed. ",11/28/2005,"11/28/2005",7/31/2013,"07/31/2013"
"Biologics",41094,"Terminated","Southern California Permanente Medical Group Blood Bank","Irvine","CA","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","CA","B-1801-13","Class II","Red Blood Cells","FJ62632",".","1 unit","Blood products, collected from a donor who was at risk for variant Creutzfeldt-Jakob Disease (vCJD), were distributed. ",9/20/2005,"09/20/2005",7/17/2013,"07/17/2013"
"Biologics",41094,"Terminated","Southern California Permanente Medical Group Blood Bank","Irvine","CA","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","CA","B-1802-13","Class II","Fresh Frozen Plasma","FJ62632",".","1 unit","Blood products, collected from a donor who was at risk for variant Creutzfeldt-Jakob Disease (vCJD), were distributed. ",9/20/2005,"09/20/2005",7/17/2013,"07/17/2013"
"Biologics",41096,"Terminated","Suncoast Communities Blood Bank, Inc.","Sarasota","FL","US","Voluntary: Firm Initiated","Telephone","Florida","B-0999-13","Class II","Platelets Pheresis Leukocytes Reduced - Triple Product","7725412(Part A); 7725412(Part B); 7725412(Part C); ",,"3 units","Blood products, which did not meet the acceptable product specifications, were distributed.",10/17/2005,"10/17/2005",4/17/2013,"04/17/2013"
"Biologics",41111,"Terminated","Community Blood Centers of South Florida, Inc.","Lauderhill","FL","US","Voluntary: Firm Initiated","Telephone","Florida","B-1987-13","Class II","Fresh Frozen Plasma","1761509",,"1 unit","Blood products, that were possibly contaminated with Enterococcus Faecalis, were distributed.",11/15/2005,"11/15/2005",7/31/2013,"07/31/2013"
"Biologics",41111,"Terminated","Community Blood Centers of South Florida, Inc.","Lauderhill","FL","US","Voluntary: Firm Initiated","Telephone","Florida","B-1986-13","Class II","Platelets","1761509",,"1 unit","Blood products, that were possibly contaminated with Enterococcus Faecalis, were distributed.",11/15/2005,"11/15/2005",7/31/2013,"07/31/2013"
"Biologics",41143,"Terminated","American Red Cross Blood Services","Omaha","NE","US","Voluntary: Firm Initiated","FAX","NE","B-1285-13","Class III","Platelets Pheresis Leukocytes Reduced","09GP11509; 09GP11509",".","2 Units","Blood products, collected using an expired blood collection set, were distributed.",11/9/2005,"11/09/2005",7/10/2013,"07/10/2013"
"Biologics",41145,"Terminated","Blood Systems, Inc.","Scottsdale","AZ","US","Voluntary: Firm Initiated","Telephone","North Carolina","B-0090-14","Class III","Blood and Blood Products for Reprocessing","106671388",".","1","Blood product, collected from a donor, whose suitability to donate was not adequately determined, was distributed.",8/15/2005,"08/15/2005",12/4/2013,"12/04/2013"
"Biologics",41155,"Terminated","LifeServe Blood Center","Des Moines","IA","US","Voluntary: Firm Initiated","Letter","Iowa","B-0703-13","Class III","Blood and Blood Products for Reprocessing","LT79278",,"1 Unit","Blood product, collected from a donor who was at risk for variant Creutzfeldt-Jakob disease (vCJD), was distributed.",8/18/2005,"08/18/2005",3/20/2013,"03/20/2013"
"Biologics",41163,"Terminated","LifeServe Blood Center","Des Moines","IA","US","Voluntary: Firm Initiated","Letter","Iowa","B-0833-13","Class II","Blood and Blood Products for Reprocessing","FW11611",,"1 Unit","Blood products, collected from a donor who was at risk for variant Creutzfeldt-Jakob Disease (vCJD), were distributed.",8/9/2005,"08/09/2005",4/3/2013,"04/03/2013"
"Biologics",41163,"Terminated","LifeServe Blood Center","Des Moines","IA","US","Voluntary: Firm Initiated","Letter","Iowa","B-0832-13","Class II","Red Blood Cells","FW11611",,"1 Unit","Blood products, collected from a donor who was at risk for variant Creutzfeldt-Jakob Disease (vCJD), were distributed.",8/9/2005,"08/09/2005",4/3/2013,"04/03/2013"
"Biologics",41190,"Terminated","American National Red Cross","Portland","OR","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Oregon and Ohio","B-0243-13","Class II","Plasma Frozen","21FV07851",".","1 unit","Blood products, collected from a donor with a history of Hepatitis, were distributed.",10/12/2005,"10/12/2005",1/2/2013,"01/02/2013"
"Biologics",41190,"Terminated","American National Red Cross","Portland","OR","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Oregon and Ohio","B-0242-13","Class II","Red Blood Cells Leukocytes Reduced","21FV07851",".","1 unit","Blood products, collected from a donor with a history of Hepatitis, were distributed.",10/12/2005,"10/12/2005",1/2/2013,"01/02/2013"
"Biologics",41200,"Terminated","Community Blood Center of the Ozarks","Springfield","MO","US","Voluntary: Firm Initiated","Letter","AR","B-0929-13","Class II","Red Blood Cells Leukocytes Reduced","6625084",".","1 unit","Blood product, collected from a donor who traveled to malarial endemic areas, was distributed. ",12/5/2005,"12/05/2005",4/24/2013,"04/24/2013"
"Biologics",41266,"Terminated","Mississippi Valley Reg Bld Ctr","Davenport","IA","US","Voluntary: Firm Initiated","Other","Switzerland","B-0471-13","Class III","Blood and Blood Products for Reprocessing","GH01615; GH00089",".","2 Units","Blood products, which did not meet the acceptable product specifications, were distributed.",11/30/2005,"11/30/2005",2/6/2013,"02/06/2013"
"Biologics",41270,"Terminated","Mississippi Valley Reg Bld Ctr","Davenport","IA","US","Voluntary: Firm Initiated","Telephone","Iowa","B-0546-13","Class II","Platelets Pheresis Leukocytes Reduced","KN03020",,"1 Unit","Blood product, which did not meet acceptable product specifications, was distributed.",11/18/2005,"11/18/2005",3/6/2013,"03/06/2013"
"Biologics",41294,"Terminated","American National Red Cross (The)","Tucson","AZ","US","Voluntary: Firm Initiated","Telephone","Arizona","B-2264-13","Class III","Blood and Blood Products for Reprocessing","007GQ16444; 007GQ16445 ",,"2 units","Blood products, collected using an expired blood collection set were expired, were distributed.",12/16/2005,"12/16/2005",9/25/2013,"09/25/2013"
"Biologics",41294,"Terminated","American National Red Cross (The)","Tucson","AZ","US","Voluntary: Firm Initiated","Telephone","Arizona","B-2263-13","Class III","Red Blood Cells Leukocytes Reduced","007GQ16444; 007GQ16445 ",,"2 units","Blood products, collected using an expired blood collection set were expired, were distributed.",12/16/2005,"12/16/2005",9/25/2013,"09/25/2013"
"Biologics",41296,"Terminated","LifeServe Blood Center","Des Moines","IA","US","Voluntary: Firm Initiated","Letter","New York","B-0173-13","Class II","Red Blood Cells","LX44682",".","1 Unit","Blood product, collected from a donor who reported travel to a malarial endemic area, was distributed.",12/22/2005,"12/22/2005",1/23/2013,"01/23/2013"
"Biologics",41304,"Terminated","Northwest Florida Blood Center, Inc.","Pensacola","FL","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","FL","B-1171-13","Class II","Platelets Leukocytes Reduced Irradiated"," 4084307",".","1 unit","Blood product, processed in a manner that may have compromised sterility, was distributed.",12/6/2005,"12/06/2005",5/29/2013,"05/29/2013"
"Biologics",41367,"Terminated","American National Red Cross (The)","Tucson","AZ","US","Voluntary: Firm Initiated","Letter","Arizona","B-2010-13","Class II","Red Blood Cells Leukocytes Reduced","007GE26161",".","1 unit","Blood product, collected from a donor who gave history which warranted deferral, was distributed.",12/8/2005,"12/08/2005",8/28/2013,"08/28/2013"
"Biologics",41369,"Terminated","San Diego Blood Bank","San Diego","CA","US","Voluntary: Firm Initiated","Telephone","California","B-2319-13","Class III","Red Blood Cells Leukocytes Reduced","GR76222; LR12974; LY72837",,"3 units","Blood products, which were not prepared in accordance with specifications, were distributed.",1/6/2006,"01/06/2006",9/25/2013,"09/25/2013"
"Biologics",41384,"Terminated","American National Red Cross (The)","Cleveland","OH","US","Voluntary: Firm Initiated","Letter","Ohio","B-1916-13","Class II","Red Blood Cells (Apheresis) Leukocytes Reduced","042E48603",".","2 components","Blood products, which did not undergo the required quality control testing, were distributed.",11/18/2005,"11/18/2005",8/14/2013,"08/14/2013"
"Biologics",41387,"Terminated","American Red Cross Blood Services","Saint Louis","MO","US","Voluntary: Firm Initiated","Telephone","Missouri","B-0646-13","Class II","Red Blood Cells","11KS10932",,"1 Unit","Blood product, collected from a donor in which hematocrit and hemoglobin was not adequately determined, was distributed.",11/2/2005,"11/02/2005",3/20/2013,"03/20/2013"
"Biologics",41392,"Terminated","San Diego Blood Bank","San Diego","CA","US","Voluntary: Firm Initiated","Telephone","California","B-2320-13","Class II","Red Blood Cells","KE33890",,"1 unit","Blood product, which was collected from a donor who traveled to a malarial endemic area, was distributed.",1/18/2006,"01/18/2006",9/25/2013,"09/25/2013"
"Biologics",41438,"Terminated","Community Blood Bank, Inc.","Rancho Mirage","CA","US","Voluntary: Firm Initiated","Letter","California","B-2555-13","Class II","Red Blood Cells Leukocytes Reduced","3520088",".","1 unit","Blood product, collected from a donor who traveled to an area considered endemic for malaria, was distributed.",1/25/2006,"01/25/2006",11/20/2013,"11/20/2013"
"Biologics",41440,"Terminated","American Red Cross Blood Services","Omaha","NE","US","Voluntary: Firm Initiated","FAX","PA, NJ","B-1284-13","Class II","Red Blood Cells Leukocytes Reduced","09FQ23731",".","1 Unit","Blood product, collected from a donor who traveled to a malaria endemic area, was distributed.",12/14/2005,"12/14/2005",7/10/2013,"07/10/2013"
"Biologics",41454,"Terminated","Mississippi Valley Reg Bld Ctr","Davenport","IA","US","Voluntary: Firm Initiated","Telephone","MO; NY; MA; IL; WA; CA; NJ; NC; IA; WI; PA; Switzerland","B-1904-13","Class III","Blood and Blood Products for Reprocessing","GC05417; GE20556; GE20557; GE20558; GE20559; GE20560; GE20561; GE20562; GE20563; GE20564; GE20566; GE20567; GE20568; GE20569; GE20570; GE20571; GE20578; GG07989 GG07990; GG07991; GG07992; GG07994; GG09135; GG09136; GG09139; GG09145; GG09148; GG09150; GG09152; GG09154; GG09156; GG09158; GG09159; GG09160; GG09163; GG09166; GG09167; GG09168; GG09169; GG09170; GG09172; GG09173; GG09174; GG09175; GG09176; GG09177; GG09178; GG09179; GG09180; GG09181; GG09182; GG09183; GG09184; GG09185; GG09186; GG09189; GG09190; GG09191; GG09192; GG09193; GG09194; GG09195; GG09196; GG09198; GG09311; GG09312; GG09315; GG09316; GG09317; GG09318; GG09319; GG09320; GG09321; GG09323; GG09324; GG09326; GG09328; GG09329; GG09331; GG09332; GG09333; GG09334; GG09337; GG09339; GG09340; GG09341; GG09343; GG09346; GG09348; GK07141; GK07144; GK07146; GK07147; GK07148; GK07149; GK07156; GK07160; GK09300; GK09301; GK09302; GK09303; GK09304; GK09305; GK09306; GK09307; GK09309; GK09311; GK09312; GK09313; GK09314; GK09315; GK09317; GK09318; GK09320; GK09321; GK09322; GK09323; GK09325; GK09328; GK09329; GK09330; GK09333; GK09334; GK09338; GK09339; GK09341; GM10521; GM10522; GM10523; GR11119; GR11120; GR11122; GR11123; GR11124; GR11126; GR11128; GR12381; GR12382; GR12383; GR12384; GR12385; GR12386; GR12388; GR12389; GR12390; GR12391; GR12392; GR12394; GR12396; GR12399; GR12400; J58969; J58970; J58975; J58979; J58983; J58986; J58987; J58990; Z20971; Z20972; Z20973; Z20974; Z20975; Z20976; Z20977; Z20978; Z20980; Z20981; Z20982; Z22601; Z22602; Z22603; Z22604; Z22609; Z22610; Z22611; Z22612; Z22613",,"179 Units","Blood products, whose Viral Testing/Testing was performed, interpreted, or documented incorrectly, were distributed.",12/16/2005,"12/16/2005",8/21/2013,"08/21/2013"
"Biologics",41454,"Terminated","Mississippi Valley Reg Bld Ctr","Davenport","IA","US","Voluntary: Firm Initiated","Telephone","MO; NY; MA; IL; WA; CA; NJ; NC; IA; WI; PA; Switzerland","B-1901-13","Class II","Red Blood Cells Leukocytes Reduced","E16324; E16324; E16325; E16325; E16510; E16510; E16910; E16910; E18484; E18484; E18486; E18486; E18488; E18488; GC05347; GC05348; GC05349; GC05350; GC05351; GC05352; GC05401; GC05402; GC05403; GC05404; GC05406; GC05407; GC05408; GC05409; GC05410; GC05411; GC05414; GC05415; GC05416; GC05417; GC05418; GC05419; GC05420; GC05421; GC05423; GC05429; GC05430; GC05432; GE20556; GE20557; GE20558; GE20559; GE20560; GE20561; GE20562; GE20563; GE20564; GE20566; GE20567; GE20568; GE20569; GE20570; GE20571; GE20573; GE20574; GE20575; GE20577; GE20580; GG07988; GG07989; GG07990; GG07991; GG07992; GG07993; GG07994; GG07995; GG07996; GG07997; GG07998; GG08000; GG09135; GG09139; GG09142; GG09144; GG09145; GG09146; GG09147; GG09148; GG09151; GG09152; GG09153; GG09154; GG09155; GG09156; GG09157; GG09158; GG09159; GG09160; GG09161; GG09162; GG09163; GG09166; GG09167; GG09168; GG09169; GG09170; GG09171; GG09172; GG09173; GG09174; GG09175; GG09176; GG09177; GG09178; GG09179; GG09180; GG09181; GG09182; GG09184; GG09185; GG09186; GG09187; GG09188; GG09189; GG09190; GG09191; GG09192; GG09194; GG09195; GG09196; GG09197; GG09198; GG09311; GG09312; GG09313; GG09314; GG09316; GG09317; GG09318; GG09319; GG09320; GG09321; GG09324; GG09325; GG09331; GG09332; GG09334; GG09336; GG09337; GG09338; GG09339; GG09341; GG09346; GG09347; GG09348; GH02286; GH02287; GH02289; GH02935; GH02936; GH02938; GH02939; GH02940; GH02941; GH02942; GH03770; GH03771; GH03772; GH03775; GH03776; GH03778; GH03781; GH03783; GH03784; GH03869; GH03870; GH03871; GH03872; GH03873; GH03874; GH03876; GK07131; GK07133; GK07135; GK07136; GK07139; GK07141; GK07142; GK07144; GK07146; GK07147; GK07148; GK07149; GK07150; GK07151; GK07152; GK07155; GK07156; GK07159; GK07160; GK09300; GK09301; GK09302; GK09303; GK09304; GK09305; GK09307; GK09308; GK09309; GK09312; GK09313; GK09315; GK09317; GK09318; GK09319; GK09320; GK09321; GK09322; GK09323; GK09326; GK09327; GK09328; GK09329; GK09330; GK09332; GK09333; GK09334; GK09338; GK09339; GK09341; GM10521; GM10522; GM10523; GM10524; GM1",,"430 Units","Blood products, whose Viral Testing/Testing was performed, interpreted, or documented incorrectly, were distributed.",12/16/2005,"12/16/2005",8/21/2013,"08/21/2013"
"Biologics",41454,"Terminated","Mississippi Valley Reg Bld Ctr","Davenport","IA","US","Voluntary: Firm Initiated","Telephone","MO; NY; MA; IL; WA; CA; NJ; NC; IA; WI; PA; Switzerland","B-1900-13","Class II","Platelets","GG09133; GG09134; GG09139; GG09141; GG09142; GG09144; GG09146; GG09147; GG09148; GG09150; GG09151; GG09153; GG09156; GG09157; GG09159; GG09161; GG09162; GG09164; GG09166; GG09168; GG09172; GG09174; GG09175; GG09177; GG09178; GG09182; GG09185; GG09187; GG09188; GG09189; GG09190; GG09191; GG09192; GG09193; GG09194; GG09195; GG09196; GG09197; GG09314; GG09316; GG09317; GG09320; GG09321; GG09324; GG09325; GG09334; GG09336; GG09338; GG09342; GG09346; GG09347; GG09348; GK09300; GK09301; GK09302; GK09304; GK09305; GK09306; GK09307; GK09308; GK09309; GK09311; GK09312; GK09315; GK09319; GK09326; GK09327; GK09328; GK09330; GK09332; GK09333; GR12382; GR12384; GR12388; GR12389; GR12390; GR12394; GR12396; GR12397; GR12399; GR12400; Z22603; Z22604; Z22605; Z22606; Z22607; Z22608; Z22611; Z22619; Z22621; Z 22624; Z22625; Z22626; Z22633",,"93 Units","Blood products, whose Viral Testing/Testing was performed, interpreted, or documented incorrectly, were distributed.",12/16/2005,"12/16/2005",8/21/2013,"08/21/2013"
"Biologics",41454,"Terminated","Mississippi Valley Reg Bld Ctr","Davenport","IA","US","Voluntary: Firm Initiated","Telephone","MO; NY; MA; IL; WA; CA; NJ; NC; IA; WI; PA; Switzerland","B-1906-13","Class II","Fresh Frozen Plasma","GE20577; GG09133; GG09134; GG09141; GG09142; GG09144; GG09146; GG09147; GG09151; GG09153; GG09155; GG09157; GG09161; GG09162; GG09164; GG09165; GG09187; GG09188; GG09197; GG09314; GG09325; GG09336; GG09338; GG09342; GG09347; GK07132; GK07137; GK07138; GK09308; GK09319; GK09326; GK09327; GK09332; GR12397; J58978; J58989; Z20985 ;Z22605; Z22606; Z22607; Z22608; Z22630; Z22631; Z22638; Z22639",,"45 Units","Blood products, whose Viral Testing/Testing was performed, interpreted, or documented incorrectly, were distributed. ",12/16/2005,"12/16/2005",8/21/2013,"08/21/2013"
"Biologics",41454,"Terminated","Mississippi Valley Reg Bld Ctr","Davenport","IA","US","Voluntary: Firm Initiated","Telephone","MO; NY; MA; IL; WA; CA; NJ; NC; IA; WI; PA; Switzerland","B-1908-13","Class II","Red Blood Cells","GC05405; GC05412; GC05413; GC05422; GC05431; GG09136; GG09137; GG09141; GG09164; GG09323; GG09328; GG09329; GG09333; GG09335; GG09343; GH03777; GK07134; GK07143; GK07154; GK07157; GK07158; GK09306; GK09310 ;GK09311; GK09314; GK09316; GK09325; GM10761; GM10932; GM11012; GM11013; GM11016; GM11017; GM11021; GM11026; GM11042; GM11047; GM11084; GM11233; GM11245; GM11248; GM11259; GM11290; GM11356; GM11359; GM11368; GR11123; GR11130; GR11133; GR11134; GR11136 ;GR12381; GR12382; GR12384; GR12385; GR12388; GR12390; GR12391; GR12392; GR12394; GR12395; GR12396; GR12398; J58965; J58966; J58971; J58974; J58980; T21297; T25193; T25194; T25195; T25196; Z20975; Z20980; Z20985; Z20990; Z22602; Z22615; Z 22616; Z22632; Z22636; Z22641",,"83 Units","Blood products, whose Viral Testing/Testing was performed, interpreted, or documented incorrectly, were distributed. ",12/16/2005,"12/16/2005",8/21/2013,"08/21/2013"
"Biologics",41454,"Terminated","Mississippi Valley Reg Bld Ctr","Davenport","IA","US","Voluntary: Firm Initiated","Telephone","MO; NY; MA; IL; WA; CA; NJ; NC; IA; WI; PA; Switzerland","B-1905-13","Class II","Cryoprecipitated AHF","GC05347; GC05348; GC05349; GC05350; GC05351; GC05352; GC05401; GC05402; GC05403; GC05404; GC05405; GC05406; GC05407; GC05408; GC05409; GC05410; GC05411; GC05412; GC05413; GC05414; GC05415; GC05416; GC05418; GC05419; GC05420; GC05421; GC05422; GC05423; GC05429; GC05430; GC05431; GC05432; GE20573; GE20574; GE20575; GG07993; GG07995; GG07997; GG07998; GG08000; GK07131; GK07133; GK07134; GK07135; GK07136; GK07139; GK07142; GK07143; GK07150; GK07151;GK07152; GK07154; GM10524; GM10525; GM10526; GM10527; GR11130; GR11131; GR11132; GR11133; GR11134; GR11135; Z20983; Z20986; Z20987; Z20989; Z20990; Z 2099; Z 20992",,"69 Units","Blood products, whose Viral Testing/Testing was performed, interpreted, or documented incorrectly, were distributed.",12/16/2005,"12/16/2005",8/21/2013,"08/21/2013"
"Biologics",41454,"Terminated","Mississippi Valley Reg Bld Ctr","Davenport","IA","US","Voluntary: Firm Initiated","Telephone","MO; NY; MA; IL; WA; CA; NJ; NC; IA; WI; PA; Switzerland","B-1903-13","Class II","Platelets Pheresis Leukocytes Reduced","KN03064; KN03065; KN03066; KN03067; KT04459; KT04460; KT04461; KT04462; KT04463; KT04464; KT04466; KT04466; KT04467; KT04468; KT04468; KT04469; KT04471; KT04471; KT04472; KW04221; KW04222; KW04222; KW04224; KW04224 ",,"24 Units","Blood products, whose Viral Testing/Testing was performed, interpreted, or documented incorrectly, were distributed.",12/16/2005,"12/16/2005",8/21/2013,"08/21/2013"
"Biologics",41454,"Terminated","Mississippi Valley Reg Bld Ctr","Davenport","IA","US","Voluntary: Firm Initiated","Telephone","MO; NY; MA; IL; WA; CA; NJ; NC; IA; WI; PA; Switzerland","B-1907-13","Class II","Platelets Pheresis Irradiated","KT04460; KT04463; KT04464; KT04465; KT04467; KW04221; KW04222; KW04223; KW04223; KW04225; KW04225 ",,"11 Units","Blood products, whose Viral Testing/Testing was performed, interpreted, or documented incorrectly, were distributed. ",12/16/2005,"12/16/2005",8/21/2013,"08/21/2013"
"Biologics",41454,"Terminated","Mississippi Valley Reg Bld Ctr","Davenport","IA","US","Voluntary: Firm Initiated","Telephone","MO; NY; MA; IL; WA; CA; NJ; NC; IA; WI; PA; Switzerland","B-1902-13","Class II","Red Blood Cells Leukocytes Reduced Irradiated","GM11056",,"1 Unit","Blood products, whose Viral Testing/Testing was performed, interpreted, or documented incorrectly, were distributed.",12/16/2005,"12/16/2005",8/21/2013,"08/21/2013"
"Biologics",41456,"Terminated","Mississippi Valley Reg Bld Ctr","Davenport","IA","US","Voluntary: Firm Initiated","Telephone","Iowa","B-0492-13","Class II","Red Blood Cells Leukocytes Reduced","C74031",".","1 Unit","Blood product, which tested as CMV positive but labeled as CMV negative, was distributed.",1/16/2006,"01/16/2006",2/6/2013,"02/06/2013"
"Biologics",41487,"Terminated","Blood Bank Of San Bernardino and Riverside Counties","San Bernardino","CA","US","Voluntary: Firm Initiated","Letter","CA, Switzerland","B-1985-13","Class III","Blood and Blood Products for Reprocessing. ","GN97147",,"1 unit","Blood products, collected from a donor considered to be at increased risk for variant Creutzfeldt-Jakob Disease (vCJD), were distributed. ",12/15/2005,"12/15/2005",8/7/2013,"08/07/2013"
"Biologics",41487,"Terminated","Blood Bank Of San Bernardino and Riverside Counties","San Bernardino","CA","US","Voluntary: Firm Initiated","Letter","CA, Switzerland","B-1984-13","Class II","Red Blood Cells (Apheresis) Leukocytes Reduced","GN97147",,"1 unit","Blood products, collected from a donor considered to be at increased risk for variant Creutzfeldt-Jakob Disease (vCJD), were distributed. ",12/15/2005,"12/15/2005",8/7/2013,"08/07/2013"
"Biologics",41489,"Terminated","DCI Biologicals, Orlando LLC","Clearwater","FL","US","Voluntary: Firm Initiated","FAX","United Kingdom","B-1170-13","Class II","Source Plasma","GN0045072; GN0045321; GN0046053; GN0048378; GN0049724; GN0049924; GN0050812; GN0051396; GN0051675; GN0053084; GN0053446; GN0054588; GN0055530; GN0055783; GN0057930; GN0058194; GN0058694; GN0059013; GN0059781; GN0060131; GN0061476; GN0061595; GN0062439; GN0063114; GN0063386; GN0063819; GN0064254; GN0064881; GN0065184.",".","29 units","Blood products, collected from a donor who received a piercing within 12 months of donation, were distributed.",1/19/2006,"01/19/2006",5/29/2013,"05/29/2013"
"Biologics",41493,"Terminated","Biomat USA, Inc.","Phoenix","AZ","US","Voluntary: Firm Initiated","Letter","CA, Spain","B-2088-13","Class III","Source Plasma","0240040461 0240040607 0240040965 0240041244 0240041520 0240041692 0240041975 0240042119 0240042387 0240042542 0240043129 0240043412 0240046534 0240047103 0240047349 0240051087 0240051325 0240051467 0240051896 0240052089 0240052589 0240052960 0240053136 0240053559 0240053689 0240054107 0240054272 0240054519 0240054707 0240057424 0240057614 0240057845 0240057951 0240058295 ",,"34 units","Blood products, collected from a donor who were previously deferred, were distributed.",1/9/2006,"01/09/2006",9/4/2013,"09/04/2013"
"Biologics",41499,"Terminated","American National Red Cross (The)","Boise","ID","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Texas, Idaho, Montana, Oklahoma, California, Florida.","B-0254-13","Class II","Blood and Blood Products for Reprocessing","020GH34105, 020GH31503, 020GH30554, 020GH26857, 020GH25072, 020GH22247, 020GH21136. ",".","7 units","Blood products, collected from an ineligible donor, were distributed. ",12/14/2005,"12/14/2005",1/30/2013,"01/30/2013"
"Biologics",41499,"Terminated","American National Red Cross (The)","Boise","ID","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Texas, Idaho, Montana, Oklahoma, California, Florida.","B-0255-13","Class II","Plasma Frozen","020GH32968.",".","1 unit","Blood products, collected from an ineligible donor, were distributed.",12/14/2005,"12/14/2005",1/30/2013,"01/30/2013"
"Biologics",41499,"Terminated","American National Red Cross (The)","Boise","ID","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Texas, Idaho, Montana, Oklahoma, California, Florida.","B-0253-13","Class II","Red Blood Cells Leukocytes Reduced","020GH34105, 020GH30554, 020GH29543, 020GH32968, 020GH31503. ",".","5 units","Blood products, collected from an ineligible donor, were distributed.",12/14/2005,"12/14/2005",1/30/2013,"01/30/2013"
"Biologics",41526,"Terminated","American National Red Cross (The)","West Henrietta","NY","US","Voluntary: Firm Initiated","Telephone","PA","B-0236-13","Class III","Blood and Blood Products for Reprocessing","30GR14000",".","1 unit","Blood products, collected from a donor in which donor suitability was not adequately determined, were distributed.",12/8/2005,"12/08/2005",1/2/2013,"01/02/2013"
"Biologics",41526,"Terminated","American National Red Cross (The)","West Henrietta","NY","US","Voluntary: Firm Initiated","Telephone","PA","B-0235-13","Class II","Red Blood Cells Leukocytes Reduced","30GR14000",".","1 unit","Blood products, collected from a donor in which donor suitability was not adequately determined, were distributed.",12/8/2005,"12/08/2005",1/2/2013,"01/02/2013"
"Biologics",41560,"Terminated","Northwest Florida Blood Center, Inc.","Pensacola","FL","US","Voluntary: Firm Initiated","Letter","Alabama.","B-2566-13","Class II","Platelets Pheresis Leukocytes Reduced","Unit number 4084302",,"1","Blood product, collected from a donor who had taken an aspirin-like medication, was distributed.",1/17/2006,"01/17/2006",11/27/2013,"11/27/2013"
"Biologics",41567,"Terminated","Florida's Blood Centers, Inc.","Orlando","FL","US","Voluntary: Firm Initiated","Telephone","Florida","B-2571-13","Class II","Red Blood Cells Leukocytes Reduced","4936348",,"1","Blood product, collected from a donor who reported travel to an area that was endemic for malaria, was distributed.",10/17/2005,"10/17/2005",11/27/2013,"11/27/2013"
"Biologics",41570,"Terminated","Childrens Hospital Los Angeles","Los Angeles","CA","US","Voluntary: Firm Initiated","Letter","CA","B-2327-13","Class III","Fresh Frozen Plasma","0141299",,"1 unit","Blood product, in which an extended collection time for FFP, was distributed.",2/23/2006,"02/23/2006",9/25/2013,"09/25/2013"
"Biologics",41575,"Terminated","American National Red Cross","Salt Lake City","UT","US","Voluntary: Firm Initiated","Telephone","Utah.","B-0827-13","Class III","Red Blood Cells Leukocytes Reduced","020Q30582.",,"1 unit","Blood product, leukoreduced after five day timing requirement, was distributed.",1/4/2006,"01/04/2006",4/3/2013,"04/03/2013"
"Biologics",41587,"Terminated","CSL Plasma Inc","Tempe","AZ","US","Voluntary: Firm Initiated","Letter","CA","B-1799-13","Class III","Source Plasma ","65630051; 65624203; 65634226, ",,"3","Blood products collected from a donor who was previously permanently, were distributed.",2/16/2006,"02/16/2006",8/7/2013,"08/07/2013"
"Biologics",41607,"Terminated","American National Red Cross (The)","Tucson","AZ","US","Voluntary: Firm Initiated","Letter","Arizona","B-2310-13","Class III","Fresh Frozen Plasma","07FJ84940(Parts A, B and C); 07GJ13755(Parts A, B and C)",,"6 units","Fresh Frozen Plasma products, not manufactured in accordance with GMPs, were distributed. ",3/6/2006,"03/06/2006",10/23/2013,"10/23/2013"
"Biologics",41615,"Terminated","Blood Systems, Inc.","Scottsdale","AZ","US","Voluntary: Firm Initiated","Telephone","AZ","B-2363-13","Class II","Red Blood Cells (Apheresis) Leukocytes Reduced","107187743- part 2",,"1 unit","Blood products, failed to meet specifications for product volume, were distributed.",1/24/2006,"01/24/2006",11/27/2013,"11/27/2013"
"Biologics",41615,"Terminated","Blood Systems, Inc.","Scottsdale","AZ","US","Voluntary: Firm Initiated","Telephone","AZ","B-2364-13","Class III","Red Blood Cells Leukocytes Reduced","107192045",,"1 unit","Blood products, failed to meet specifications for product volume, were distributed.",1/24/2006,"01/24/2006",11/27/2013,"11/27/2013"
"Biologics",41619,"Terminated","BioLife Plasma Services L.P.","Van Nuys","CA","US","Voluntary: Firm Initiated","FAX","California","B-1706-13","Class II","Source Plasma","05MTNA8618",,"1","Blood product, collected from a donor who was previously HIV-1/2 reactive, was distributed.",11/29/2005,"11/29/2005",7/3/2013,"07/03/2013"
"Biologics",41626,"Terminated","BioLife Plasma Services L.P.","Van Nuys","CA","US","Voluntary: Firm Initiated","FAX","California","B-1927-13","Class II","Source Plasma","05RCAB4721",".","1 unit","Blood product, which was not quarantined after receiving information regarding the donor's contact with a person who tested reactive for HBsAg, was distributed.",10/21/2005,"10/21/2005",8/14/2013,"08/14/2013"
"Biologics",41639,"Terminated","CSL Plasma Inc","Boca Raton","FL","US","Voluntary: Firm Initiated","Letter","North Carolina","B-2004-13","Class II","Source Plasma","0480908143; 0480907970; 0480907276; 0480906431; 0480906175",".","5 units","Blood products, collected from a donor who did not have a complete physical examination, were distributed.",1/19/2006,"01/19/2006",8/28/2013,"08/28/2013"
"Biologics",41692,"Terminated","Community Blood Center of the Ozarks","Springfield","MO","US","Voluntary: Firm Initiated","Letter","MO; AL; NJ; TX; OH; AR; FL; TN; MD","B-1242-13","Class II","Cryoprecipitated AHF","6649425; 6649457; 6659087; 6659089; 6659092; 6659103; 6659109; 6659113; 6664719; 6665319; 6667046 ",".","11 Units","Blood products, collected in a manner that may have compromised the sterility of the collection system, were distributed.",3/13/2006,"03/13/2006",6/5/2013,"06/05/2013"
"Biologics",41692,"Terminated","Community Blood Center of the Ozarks","Springfield","MO","US","Voluntary: Firm Initiated","Letter","MO; AL; NJ; TX; OH; AR; FL; TN; MD","B-1247-13","Class II","Platelets","6631299; 6642184; 6648158; 6648165; 6648509; 6650155; 6650188; 6650472; 6650508; 6654804; 6654841; 6654846; 6654920; 6654940; 6655058; 6655074; 6655083; 6655089; 6655094; 6655096; 6655145; 6656667; 6656682; 6656696; 6656792; 6656804; 6656824; 6656842; 6657703; 6657772; 6657802; 6657804; 6657806; 6657809; 6658068; 6661565; 6661592; 6661601; 6661604; 6661612; 6661627; 6663323; 6664339; 6664390; 6664398; 6664409; 6664938; 6664946; 6665740; 6665743; 6665756; 6665764; 6665765; 6666373; 6666390; 6666401; 6666734; 6666759; 6666906; 6666909; 6666919; 6668800; 6668802; 6668807; 6669182; 6669397; 6669450; 6672678; 6672682; 6672683; 6672690; 6672697; 6672715; 6674946; 6674970; 6674972; 6675016; 6675560; 6675563; 6675888; 6675931; 6675973; 6676497; 6677563; 6677588; 6677597; 6677598; 6677979; 6678053; 6678065; 6678089; 6681181; 6681192; 6681204; 6681954; 6682248; 6682356; 6682365; 6682380; 6682387; 6682396; 6682399; 6682403; 6682406; 6682473; 6682478; 6682502; 6683014; 6683015; 6683018; 6683019; 6683173; 6683208; 6683212; 6683222; 6683386; 6683387; 6683400; 6683403; 6683746; 6683752; 6683753; 6685148; 6685153; 6685157; 6685181; 6685187; 6685190; 6688178; 6688196; 6688202; 6688768; 6688816; 6675013",".","132 Units","Blood products, collected in a manner that may have compromised the sterility of the collection system, were distributed.",3/13/2006,"03/13/2006",6/5/2013,"06/05/2013"
"Biologics",41692,"Terminated","Community Blood Center of the Ozarks","Springfield","MO","US","Voluntary: Firm Initiated","Letter","MO; AL; NJ; TX; OH; AR; FL; TN; MD","B-1243-13","Class II","Plasma Cryoprecipitate Reduced","6659087; 6659089; 6659092; 6659109; 6659132; 6665305 ",".","6 Units","Blood products, collected in a manner that may have compromised the sterility of the collection system, were distributed.",3/13/2006,"03/13/2006",6/5/2013,"06/05/2013"
"Biologics",41692,"Terminated","Community Blood Center of the Ozarks","Springfield","MO","US","Voluntary: Firm Initiated","Letter","MO; AL; NJ; TX; OH; AR; FL; TN; MD","B-1244-13","Class II","Red Blood Cells Irradiated","6653749; 6675572; 6677598 ",".","3 Units","Blood products, collected in a manner that may have compromised the sterility of the collection system, were distributed.",3/13/2006,"03/13/2006",6/5/2013,"06/05/2013"
"Biologics",41692,"Terminated","Community Blood Center of the Ozarks","Springfield","MO","US","Voluntary: Firm Initiated","Letter","MO; AL; NJ; TX; OH; AR; FL; TN; MD","B-1248-13","Class II","Fresh Frozen Plasma","6659164; 6631297; 6642184; 6642186; 6642196; 6644449; 6644451; 6644472; 6644477; 6644483; 6644485; 6645305; 6645308; 6645310; 6645336; 6648165; 6648167; 6648685; 6648706; 6648710; 6648722; 6648725; 6650191; 6650472; 6650475; 6650496; 6650508; 6650509; 6653060; 6654920; 6654940; 6654957; 6655053; 6655058; 6655074; 6655083; 6655089; 6655094; 6655096; 6655525; 6656682; 6656710; 6656713; 6656731; 6656747; 6656751; 6656753; 6656768; 6656769; 6656785; 6656804; 6656806; 6657703; 6657705; 6657708; 6657711; 6657772; 6657783; 6657787; 6657802; 6657804; 6657806; 6657809; 6657812; 6658050; 6658068; 6658071; 6659158; 6661592; 6661604; 6661631; 6663341; 6664501; 6664938; 6664942; 6664946; 6665740; 6665743; 6665756; 6665766; 6666734; 6666759; 6666762; 6666906; 6666919; 6666938; 6666945; 6666973; 6667206; 6667215; 6667225; 6667265; 6668802; 6669182; 6669184; 6669397; 6669408; 6669450; 6669460; 6669489; 6672673; 6672678; 6672690; 6672697; 6672718; 6672727; 6672988; 6673598; 6674941; 6674946; 6674959; 6674970; 6674972; 6674977; 6674978; 6674980; 6674984; 6674996; 6675563; 6676483; 6676497; 6676499; 6676810; 6676811; 6677563; 6677567; 6677571; 6677588; 6677602; 6677979; 6678089; 6681181; 6681192; 6681204; 6681206; 6681604; 6681609; 6681612; 6681616; 6682224; 6682248; 6682383; 6682399; 6682473; 6682478; 6682502; 6683587; 6683592; 6683594; 6683615",".","149 Units","Blood products, collected in a manner that may have compromised the sterility of the collection system, were distributed.",3/13/2006,"03/13/2006",6/5/2013,"06/05/2013"
"Biologics",41692,"Terminated","Community Blood Center of the Ozarks","Springfield","MO","US","Voluntary: Firm Initiated","Letter","MO; AL; NJ; TX; OH; AR; FL; TN; MD","B-1245-13","Class II","Red Blood Cells Leukocytes Reduced Irradiated","6657393; 6658379; 6662239; 6665764; 6666351; 6666704; 6672394; 6683753 ",".","8 Units","Blood products, collected in a manner that may have compromised the sterility of the collection system, were distributed.",3/13/2006,"03/13/2006",6/5/2013,"06/05/2013"
"Biologics",41692,"Terminated","Community Blood Center of the Ozarks","Springfield","MO","US","Voluntary: Firm Initiated","Letter","MO; AL; NJ; TX; OH; AR; FL; TN; MD","B-1249-13","Class II","Red Blood Cells","6631299; 6631302; 6642054; 6642061; 6642072; 6642077; 6642184; 6642186; 6642196; 6644447; 6644451; 6644483; 6645305; 6645315; 6645332; 6645343; 6647910; 6647911; 6647912; 6648158; 6648165; 6648167; 6648196; 6648206; 6648215; 6648216; 6648220; 6648457; 6648463; 6648481; 6648645; 6648681; 6648682; 6648685; 6648706; 6648710; 6648722; 6648725; 6648756; 6648759; 6648762; 6648832; 6649339; 6649344; 6649347; 6649352; 6649378; 6649405; 6649417; 6649421; 6649425; 6649457; 6650165; 6650169; 6650188; 6650191; 6650209; 6650404; 6650406; 6650408; 6650414; 6650422; 6650472; 6650473; 6650475; 6650486; 6650491; 6650496; 6650501; 6650508; 6650509; 6652910; 6652911; 6652912; 6652914; 6652915; 6653500; 6653503; 6653513; 6653746; 6654846; 6654940; 6654957; 6655053; 6655058; 6655062; 6655074; 6655081; 6655083; 6655089; 6655094; 6655096; 6655104; 6655122; 6655130; 6655520; 6655524; 6655525; 6655528; 6655531; 6656680; 6656681; 6656689; 6656707; 6656708; 6656710; 6656731; 6656753; 6656768; 6656790; 6656792; 6656804; 6656806; 6656807; 6656809; 6656824; 6656826; 6656831; 6656842; 6657394; 6657407; 6657423; 6657444; 6657447; 6657459; 6657461; 6657504; 6657512; 6657518; 6657535; 6657536; 6657540; 6657545; 6657556; 6657582; 6657599; 6657637; 6657641; 6657649; 6657670; 6657675; 6657688; 6657690; 6657692; 6657694; 6657697; 6657703; 6657705; 6657708; 6657711; 6657765; 6657766; 6657769; 6657770; 6657778; 6657785; 6657787; 6657802; 6657804; 6657806; 6657809; 6658028; 6658040; 6658050; 6658068; 6658071; 6658347; 6658366; 6658370; 6658385; 6658388; 6658391; 6659087; 6659089; 6659092; 6659096; 6659103; 6659106; 6659107; 6659109; 6659113; 6659132; 6659158; 6659159; 6659164; 6659353; 6659387; 6659477; 6659484; 6659519; 6659526; 6659534; 6659558; 6659567; 6659572; 6659577; 6659586; 6660751; 6660753; 6660771; 6660774; 6660778; 6660780; 6660790; 6660803; 6660811; 6661223; 6661233; 6661238; 6661258; 6661291; 6661296; 6661565; 6661568; 6661569; 6661579; 6661592; 6661601; 6661604; 6661606; 6661612; 6661627; 6661631; 6661785; 6661786; 6661794; 6662135; 66",".","599 Units","Blood products, collected in a manner that may have compromised the sterility of the collection system, were distributed.",3/13/2006,"03/13/2006",6/5/2013,"06/05/2013"
"Biologics",41692,"Terminated","Community Blood Center of the Ozarks","Springfield","MO","US","Voluntary: Firm Initiated","Letter","MO; AL; NJ; TX; OH; AR; FL; TN; MD","B-1246-13","Class II","Red Blood Cells Leukocytes Reduced","6631297; 6631298; 6631306; 6642075; 6644449; 6644454; 6644472; 6644477; 6644485; 6644490; 6645308; 6645310; 6645311; 6645336; 6648163; 6648184; 6648191; 6648194; 6648486; 6648493; 6648509; 6648643; 6648659; 6648664; 6650172; 6650426; 6653060; 6654801; 6654804; 6654813; 6654838; 6654841; 6654920; 6655131; 6655133; 6655145; 6655534; 6655715; 6655718; 6655719; 6656667; 6656682; 6656696; 6656713; 6656714; 6656747; 6656751; 6656769; 6656785; 6656828; 6657630; 6657643; 6657651; 6657678; 6657680; 6657772; 6657783; 6658045; 6659437; 6659448; 6659537; 6659564; 6661572; 6664688; 6664712; 6664719; 6664721; 6664727; 6664936; 6665732; 6665743; 6665760; 6665792; 6666390; 6668800; 6668802; 6669194; 6669397; 6669408; 6669450; 6669460; 6669489; 6670615; 6672311; 6672399; 6672406; 6672812; 6674206; 6674953; 6674978; 6674984; 6675016; 6675455; 6675571; 6675903; 6676347; 6676349; 6676355; 6676369; 6676371; 6676382; 6676391; 6676759; 6676768; 6677968; 6677971; 6677976; 6677979; 6677988; 6678025; 6678032; 6678045; 6678053; 6678058; 6678065; 6678089; 6682015; 6682088; 6682089; 6682229; 6682247; 6682248; 6682370; 6682374; 6682383; 6683403; 6683420; 6683422; 6683746; 6688102",".","129 Units","Blood products, collected in a manner that may have compromised the sterility of the collection system, were distributed.",3/13/2006,"03/13/2006",6/5/2013,"06/05/2013"
"Biologics",41701,"Terminated","American Red Cross Blood Services","Saint Louis","MO","US","Voluntary: Firm Initiated","Telephone","Missouri","B-0648-13","Class II","Red Blood Cells Leukocytes Reduced","03LE38562",,"1 Unit","Blood product, which was in transit greater than 24 hours, was distributed. ",2/20/2006,"02/20/2006",4/17/2013,"04/17/2013"
"Biologics",41720,"Terminated","Tri-counties Blood Bank","Phoenix","AZ","US","Voluntary: Firm Initiated","Letter","California","B-1849-13","Class II","Red Blood Cells (Apheresis) Leukocytes Reduced","FZ65185",".","1 unit","Blood product, which failed to meet the minimum specification for product volume, was distributed. ",2/2/2006,"02/02/2006",8/28/2013,"08/28/2013"
"Biologics",41722,"Terminated","Tri-counties Blood Bank","Phoenix","AZ","US","Voluntary: Firm Initiated","Letter","California","B-1850-13","Class III","Red Blood Cells (Apheresis) Leukocytes Reduced","GW79769; GW79769",".","2 units","Blood products, were not quarantined or measured to confirm an acceptable RBC volume, were distributed.",3/3/2006,"03/03/2006",8/28/2013,"08/28/2013"
"Biologics",41746,"Terminated","Community Blood Bank, Inc.","Rancho Mirage","CA","US","Voluntary: Firm Initiated","Letter","California.","B-2321-13","Class II","Platelets Pheresis Leukocytes Reduced Irradiated","3532562",,"1 unit","Blood product, which did not meet the acceptable product specifications, was distributed.",3/22/2006,"03/22/2006",9/25/2013,"09/25/2013"
"Biologics",41755,"Terminated","LifeShare Community Blood Services","Elyria","OH","US","Voluntary: Firm Initiated","Letter","Ohio","B-2188-13","Class III","Fresh Frozen Plasma","0815664;0815603;6818886;0815374; 6819007;0500545;0709999;6819018; 6819021;3400181",".","10","Blood products, which were not manufactured in accordance with required specifications, were distributed.",2/13/2006,"02/13/2006",9/18/2013,"09/18/2013"
"Biologics",41826,"Terminated","The American National Red Cross South Carolina Region","Columbia","SC","US","Voluntary: Firm Initiated","Telephone","SC","B-1710-13","Class II","Red Blood Cells (Apheresis) Leukocytes Reduced","36LE12634 Part 1, 36LE12634 Part 2",".","2 units","Blood products, which did not meet the acceptable product specifications, were distributed.",2/21/2006,"02/21/2006",7/17/2013,"07/17/2013"
"Biologics",41832,"Terminated","Northwest Florida Blood Center, Inc.","Pensacola","FL","US","Voluntary: Firm Initiated","FAX","FL","B-1693-13","Class III","Red Blood Cells Leukocytes Reduced","5203937",".","1 unit","Blood product, collected from a donor who was at risk for leishmaniasis, was distributed.",2/20/2006,"02/20/2006",7/10/2013,"07/10/2013"
"Biologics",41848,"Terminated","Biomat USA, Inc.","Salt Lake City","UT","US","Voluntary: Firm Initiated","Letter","Spain","B-0318-13","Class III","Source Plasma","0440061470",".","1 unit","Blood product, collected from a donor for whom donor suitability was not adequately determined, was distributed.",3/17/2006,"03/17/2006",1/16/2013,"01/16/2013"
"Biologics",41850,"Terminated","Biomat USA, Inc.","Taylorsville","UT","US","Voluntary: Firm Initiated","Letter","Spain","B-0319-13","Class III","Source Plasma","0440060645",".","1 unit","Blood product, collected from a donor for whom donor suitability was not adequately determined, was distributed.",3/17/2006,"03/17/2006",1/16/2013,"01/16/2013"
"Biologics",41852,"Terminated","Biomat USA, Inc.","Taylorsville","UT","US","Voluntary: Firm Initiated","Letter","Spain","B-0320-13","Class III","Source Plasma","0440062579",".","1 unit","Blood product, collected from a donor for whom donor suitability was not adequately determined, was distributed.",3/17/2006,"03/17/2006",1/16/2013,"01/16/2013"
"Biologics",41854,"Terminated","Biomat USA, Inc.","Taylorsville","UT","US","Voluntary: Firm Initiated","Letter","Spain","B-0321-13","Class III","Source Plasma","0440062480",".","1 unit","Blood product, collected from a donor for whom donor suitability was not adequately determined, was distributed.",3/17/2006,"03/17/2006",1/16/2013,"01/16/2013"
"Biologics",41895,"Terminated","American National Red Cross (The)","Omaha","NE","US","Voluntary: Firm Initiated","FAX","NE","B-0585-13","Class II","Red Blood Cells Leukocytes Reduced","09FZ51123; 09FZ51136",,"2 units","Blood products, collected from donors whose arm scrubs may have been incorrectly performed, were distributed.",4/14/2006,"04/14/2006",3/20/2013,"03/20/2013"
"Biologics",41903,"Terminated","Puget Sound Blood Center and Program","Seattle","WA","US","Voluntary: Firm Initiated","Letter","Washington.","B-0441-13","Class II","Red Blood Cells Leukocytes Reduced","G177400",".","1 component","Blood product, which was collected in a manner that may have compromised the sterility of the collection system, was distributed.",4/6/2006,"04/06/2006",2/6/2013,"02/06/2013"
"Biologics",41905,"Terminated","Community Blood Center of the Ozarks","Springfield","MO","US","Voluntary: Firm Initiated","Letter","MO, Austria","B-0649-13","Class II","Red Blood Cells","6690261 ",,"1 unit","Blood products, which were collected from a donor who traveled to a malarial endemic area, were distributed.",3/31/2006,"03/31/2006",3/20/2013,"03/20/2013"
"Biologics",41921,"Terminated","Siouxland Community Blood Bank","Sioux City","IA","US","Voluntary: Firm Initiated","Letter","IA, Austria","B-0651-13","Class II","Red Blood Cells Leukocytes Reduced","2024507",,"1 unit","Blood products, collected from a donor who received a MMR vaccine, were distributed.",3/13/2006,"03/13/2006",3/20/2013,"03/20/2013"
"Biologics",41931,"Terminated","American National Red Cross","Portland","OR","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","CA","B-2021-13","Class II","Plasma Frozen Cryoprecipitated Reduced","21LC39439, 21LC39442, 21LC39444, 21LC39458, 21LC39474, 21LC39477, 21LC39482, 21LC39486, 21LC39489, 21LC39499.",,"10 units","Blood products, collected in a manner that may have compromised the sterility of the collection system, were distributed.",3/9/2006,"03/09/2006",8/21/2013,"08/21/2013"
"Biologics",41931,"Terminated","American National Red Cross","Portland","OR","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","CA","B-2017-13","Class II","Red Blood Cells","21GV32332, 21GV21927, 21GV21928, 21GV21932, 21GV21934, 21GV21952, 21GV21957, 21GV21959, 21GV21961, 21GV21965, 21GV21973, 21GV21976, 21GV21978, 21GV21983, 21GV22038, 21GV22050, 21GV22054, 21GV22074, 21GV22076, 21GV22085, 21GV22092, 21GV22095, 21GV22097, 21GV22099, 21GV22105, 21GV22106, 21GV22116, 21GV22117, 21GV22242, 21GV22245, 21GV22247, 21GV22250, 21GV22252, 21GV22254, 21GV22262, 21GV22264, 21GV22265, 21GV22267, 21GV22269, 21GV22272, 21GV22274, 21GV22276, 21GV22280, 21GV22281, 21GV22284, 21GV22288, 21GV22289, 21GV22294, 21GV22299, 21GV22332, 21GV22356, 21GV22358, 21GV22360, 21GV22363, 21GV22367, 21GV22377, 21GV22382, 21GV22387, 21GV22394, 21GV22400, 21GV22406, 21GV22409, 21GV22416, 21GV22421, 21GV22438, 21GV22450, 21GV22452, 21GV22464, 21GV22469, 21GV22547, 21GV22663, 21GV22665, 21GV22670, 21GV22674, 21GV22676, 21GV22682, 21GV22686, 21GV22689, 21GV22693, 21GV22697, 21GV22700, 21GV22702, 21GV22706, 21GV22709, 21GV22719, 21GV22721, 21GV22725, 21GV22727, 21GV22730, 21GV22732, 21GV22733, 21GV22736, 21GV22742, 21GV22746, 21GV22749, 21GV22759, 21GV22889, 21GV22891, 21GV22896, 21GV22905, 21GV22908, 21GV22916, 21GV22917, 21GV22923, 21GV22928, 21GV22931, 21GV22935, 21GV22940, 21GV23008, 21GV23009, 21GV23016, 21GV23021, 21GV23033, 21GV23034, 21GV23054, 21GV23064, 21GV23066, 21GV23260, 21GV23261, 21GV23274, 21GV23275, 21GV23282, 21GV23283, 21GV23284, 21GV23291, 21GV23293, 21GV23296, 21GV23300, 21GV23306, 21GV23311, 21GV23315, 21GV23354, 21GV23371, 21GV23375, 21GV23383, 21GV23600, 21GV23606, 21GV23654, 21GV23658, 21GV23669, 21GV23680, 21GV23691, 21GV23701, 21GV23707, 21GV23721, 21GV23965, 21GV23966, 21GV23970, 21GV23974, 21GV23982, 21GV24145, 21GV24145, 21GV24158, 21GV24164, 21GV24205, 21GV24213, 21GV24242, 21GV24251, 21GV24271, 21GV24467, 21GV24470, 21GV24473, 21GV24477, 21GV24478, 21GV24481, 21GV24483, 21GV24485, 21GV24487, 21GV24488, 21GV24574, 21GV24586, 21GV24600, 21GV24601, 21GV24605, 21GV24607, 21GV24622, 21GV24648, 21GV25008, 21GV25023, 21GV25031, 21GV25042, 21GV25075, 21GV25078, 21GV25090, 21GV25093, 21GV25095,",,"1857 units","Blood products, collected in a manner that may have compromised the sterility of the collection system, were distributed.",3/9/2006,"03/09/2006",8/21/2013,"08/21/2013"
"Biologics",41931,"Terminated","American National Red Cross","Portland","OR","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","CA","B-2016-13","Class II","Cryoprecipitated AHF","21LC39433, 21LC39436, 21LC39439, 21LC39442, 21LC39444, 21LC39453, 21LC39455, 21LC39456, 21LC39458, 21LC39468, 21LC39469, 21LC39470, 21LC39474, 21LC39477, 21LC39479, 21LC39482, 21LC39486, 21LC39489, 21LC39496, 21LC39499, 21LC39502, 21LC39510.",,"22 units","Blood products, collected in a manner that may have compromised the sterility of the collection system, were distributed.",3/9/2006,"03/09/2006",8/21/2013,"08/21/2013"
"Biologics",41931,"Terminated","American National Red Cross","Portland","OR","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","CA","B-2020-13","Class II","Red Blood Cells Leukocytes Reduced Irradiated","21FV05867, 21GV22060, 21GV22326, 21GV23122, 21GV25436, 21GV25453, 21GV25696, 21GV28849, 21GV28873, 21GV31557, 21GV31597, 21GV33315, 21KF47698, 21KM65687, 21KM65713, 21KM65751, 21KM66090, 21KM66112, 21KM66775, 21KM67062, 21KM67113, 21KM67214, 21KM67991, 21KM69221, 21KM69232, 21KM70431, 21KM70813, 21KM70839, 21KM71168, 21KM71179, 21KM73336, 21KM74436, 21KM74441, 21KM74458, 21LC39479, 21LC39518, 21LC39542, 21LC39571, 21N 17117, 21N 17698. ",,"40 units","Blood products, collected in a manner that may have compromised the sterility of the collection system, were distributed.",3/9/2006,"03/09/2006",8/21/2013,"08/21/2013"
"Biologics",41931,"Terminated","American National Red Cross","Portland","OR","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","CA","B-2018-13","Class II","Red Blood Cells Washed","21KM69651 ",,"1 unit","Blood products, collected in a manner that may have compromised the sterility of the collection system, were distributed.",3/9/2006,"03/09/2006",8/21/2013,"08/21/2013"
"Biologics",41931,"Terminated","American National Red Cross","Portland","OR","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","CA","B-2019-13","Class II","Cryoprecipitate AHF, Pooled","21LC39493; 21LC39497 ",,"2 units","Blood products, collected in a manner that may have compromised the sterility of the collection system, were distributed.",3/9/2006,"03/09/2006",8/21/2013,"08/21/2013"
"Biologics",41931,"Terminated","American National Red Cross","Portland","OR","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","CA","B-2015-13","Class II","Plasma Frozen","21FL94470, 21FL94476, 21FL94481, 21FL94490, 21FL94526, 21FL94529, 21FL94534, 21FL94543, 21FL94555, 21FL94565, 21FL94566, 21FV05688, 21FV05777, 21FV05790, 21FV05861, 21FV05877, 21FV05897, 21GV22038, 21GV22057, 21GV22065, 21GV22074, 21GV22085, 21GV22095, 21GV22106, 21GV22116, 21GV22252, 21GV22265, 21GV22284, 21GV22303, 21GV22305, 21GV22307, 21GV22312, 21GV22341, 21GV22343, 21GV22347, 21GV22349, 21GV22351, 21GV22358, 21GV22363, 21GV22367, 21GV22382, 21GV22406, 21GV22430, 21GV22665, 21GV22757, 21GV22996, 21GV23001, 21GV23009, 21GV23023, 21GV23033, 21GV23039, 21GV23060, 21GV23064, 21GV23066, 21GV23108, 21GV23329, 21GV23359, 21GV23367, 21GV23455, 21GV23464, 21GV23502, 21GV23552, 21GV23590, 21GV23603, 21GV23626, 21GV23966, 21GV24158, 21GV24164, 21GV24173, 21GV24205, 21GV24449, 21GV24470, 21GV24574, 21GV24578, 21GV24706, 21GV25008, 21GV25016, 21GV25031, 21GV25045, 21GV25075, 21GV25078, 21GV25093, 21GV25095, 21GV25105, 21GV25225, 21GV25251, 21GV25268, 21GV25338, 21GV25342, 21GV25343, 21GV25348, 21GV25368, 21GV25456, 21GV25496, 21GV25509, 21GV25629, 21GV25647, 21GV25663, 21GV25672, 21GV25676, 21GV25713, 21GV25716, 21GV26362, 21GV26372, 21GV26375, 21GV26398, 21GV26408, 21GV26410, 21GV26412, 21GV26414, 21GV26877, 21GV27198, 21GV27201, 21GV27204, 21GV27217, 21GV27224, 21GV27237, 21GV27239, 21GV27245, 21GV27256, 21GV27264, 21GV27298, 21GV27300, 21GV27307, 21GV27314, 21GV27338, 21GV27368, 21GV27381, 21GV27405, 21GV27406, 21GV27419, 21GV27420, 21GV27430, 21GV27497, 21GV27498, 21GV27542, 21GV27567, 21GV27572, 21GV27573, 21GV27577, 21GV27589, 21GV27604, 21GV27605, 21GV27613, 21GV27617, 21GV27630, 21GV27634, 21GV27735, 21GV27747, 21GV28006, 21GV28012, 21GV28015, 21GV28016, 21GV28017, 21GV28036, 21GV28042, 21GV28045, 21GV28057, 21GV28058, 21GV28075, 21GV28080, 21GV28097, 21GV28098, 21GV28105, 21GV28109, 21GV28112, 21GV28117, 21GV28121, 21GV28122, 21GV28123, 21GV28128, 21GV28213, 21GV28229, 21GV28260, 21GV28451, 21GV28453, 21GV28454, 21GV28455, 21GV28457, 21GV28459, 21GV28462, 21GV28465, 21GV28466, 21GV28467, 21GV28471, 21GV28472,",,"822 units","Blood products, collected in a manner that may have compromised the sterility of the collection system, were distributed.",3/9/2006,"03/09/2006",8/21/2013,"08/21/2013"
"Biologics",41931,"Terminated","American National Red Cross","Portland","OR","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","CA","B-2014-13","Class II","Red Blood Cells Leukocytes Reduced","21LE11513, 21KM70B40, 21GV22033, 21GV22057, 21GV22058, 21GV22063, 21GV22065, 21GV22066, 21GV22067, 21GV22080, 21GV22094, 21GV22102, 21GV22129, 21GV22133, 21GV22135, 21GV22143, 21GV22144, 21GV22145, 21GV22319, 21GV22341, 21GV22351, 21GV22542, 21GV22550, 21GV22553, 21GV22558, 21GV22574, 21GV22580, 21GV22587, 21GV22588, 21GV22760, 21GV22843, 21GV22844, 21GV22849, 21GV22856, 21GV22872, 21GV22883, 21GV22884, 21GV22893, 21GV23053, 21GV23082, 21GV23119, 21GV23127, 21GV23136, 21GV23138, 21GV23307, 21GV23326, 21GV23335, 21GV23338, 21GV23342, 21GV23350, 21GV23352, 21GV23358, 21GV23359, 21GV23363, 21GV23456, 21GV23472, 21GV23478, 21GV23486, 21GV23487, 21GV23489, 21GV23550, 21GV23552, 21GV23591, 21GV23603, 21GV23605, 21GV23625, 21GV23632, 21GV23642, 21GV23655, 21GV23664, 21GV23689, 21GV23731, 21GV23735, 21GV23741, 21GV24103, 21GV24116, 21GV24240, 21GV24245, 21GV24269, 21GV24449, 21GV24452, 21GV24460, 21GV24463, 21GV24464, 21GV24701, 21GV24703, 21GV24714, 21GV24858, 21GV24905, 21GV24921, 21GV25012, 21GV25451, 21GV25456, 21GV25457, 21GV25460, 21GV25462, 21GV25484, 21GV25485, 21KM65320, 21KM65325, 21KM65328, 21KM65331, 21KM65429, 21KM65589, 21KM65590, 21KM65592, 21KM65612, 21KM65624, 21KM65627, 21KM65639, 21KM65648, 21KM65737, 21KM65741, 21KM65746, 21KM65748, 21KM65761, 21KM65768, 21KM65774, 21KM65776, 21KM66001, 21KM66043, 21KM66067, 21KM66076, 21KM66188, 21KM66191, 21KM66196, 21KM66198, 21KM66206, 21KM66207, 21KM66229, 21KM66236, 21KM66243, 21KM66247, 21KM66248, 21KM66249, 21KM66252, 21KM66260, 21KM66506, 21KM66523, 21KM66526, 21KM66601, 21KM66603, 21KM66693, 21KM66722, 21KM66724, 21KM66743, 21KM66753, 21KM66756, 21KM66758, 21KM66760, 21KM66762, 21KM66764, 21KM66935, 21KM66942, 21KM66946, 21KM67034, 21KM67038, 21KM67042, 21KM67064, 21KM67067, 21KM67076, 21KM67078, 21KM67094, 21KM67098, 21KM67109, 21KM67111, 21KM67149, 21KM67193, 21KM67201, 21KM67232, 21KM67246, 21KM67257, 21KM67278, 21KM67295, 21KM67307, 21KM67314, 21KM67326, 21KM67518, 21KM67524, 21KM67650, 21KM67661, 21KM67670, 21KM67819, 21KM67829, 21KM67631, 21KM67844,",,"1756 units","Blood products, collected in a manner that may have compromised the sterility of the collection system, were distributed.",3/9/2006,"03/09/2006",8/21/2013,"08/21/2013"
"Biologics",41935,"Terminated","American National Red Cross","Portland","OR","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Oregon and Florida","B-0237-13","Class II","Red Blood Cells Leukocytes Reduced","21FJ45454",".","1 unit","Blood products, collected from a donor in which donor suitability was not adequately determined, were distributed.",3/13/2005,"03/13/2005",1/2/2013,"01/02/2013"
"Biologics",41935,"Terminated","American National Red Cross","Portland","OR","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Oregon and Florida","B-0238-13","Class III","Blood and Blood Products for Reprocessing","21FJ45454",".","1 unit","Blood products, collected from a donor in which donor suitability was not adequately determined, were distributed.",3/13/2005,"03/13/2005",1/2/2013,"01/02/2013"
"Biologics",41936,"Terminated","American National Red Cross","Portland","OR","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Florida, Oregon, and Washington","B-0233-13","Class II","Cryoprecipitated AHF, Pooled","21LH29445",".","1 unit","Blood products, collected from a donor who received a tattoo within 12 months of donation, were distributed.",3/13/2006,"03/13/2006",1/2/2013,"01/02/2013"
"Biologics",41936,"Terminated","American National Red Cross","Portland","OR","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Florida, Oregon, and Washington","B-0234-13","Class II","Blood and Blood Products for Reprocessing","21LH29445",".","1 unit","Blood products, collected from a donor who received a tattoo within 12 months of donation, were distributed.",3/13/2006,"03/13/2006",1/2/2013,"01/02/2013"
"Biologics",41936,"Terminated","American National Red Cross","Portland","OR","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Florida, Oregon, and Washington","B-0232-13","Class II","Red Blood Cells Leukocytes Reduced","21LH29445",".","1 unit","Blood products, collected from a donor who received a tattoo within 12 months of donation, were distributed.",3/13/2006,"03/13/2006",1/2/2013,"01/02/2013"
"Biologics",41939,"Terminated","BioLife Plasma Services L.P.","Laramie","WY","US","Voluntary: Firm Initiated","FAX","CA","B-0135-14","Class II","Source Plasma","05LWYE3208, 05LWYE4414, 05LWYE4775",,"3 units","Blood products, collected from a donor who received a MMR vaccine prior to donation, were distributed.",3/9/2006,"03/09/2006",12/18/2013,"12/18/2013"
"Biologics",41943,"Terminated","American Red Cross Blood Services","Saint Louis","MO","US","Voluntary: Firm Initiated","Letter","Missouri","B-0624-13","Class II","Red Blood Cells (Apheresis) Leukocytes Reduced","11KJ01769",".","1 Unit","Blood product, labeled as leukoreduced without the assurance that it met the criteria for a leukoreduced product, was distributed.",3/29/2006,"03/29/2006",2/27/2013,"02/27/2013"
"Biologics",41949,"Terminated","Hoxworth Blood Center University of Cincinnati Medical Center","Cincinnati","OH","US","Voluntary: Firm Initiated","Letter","Ohio, Kentucky, Pennsylvania","B-2345-13","Class II","Red Blood Cells Leukocytes Reduced","1613444, 1190847",".","2 units","Blood products, which were collected from a donor who traveled to a malarial endemic area, were distributed.",2/15/2006,"02/15/2006",9/18/2013,"09/18/2013"
"Biologics",41949,"Terminated","Hoxworth Blood Center University of Cincinnati Medical Center","Cincinnati","OH","US","Voluntary: Firm Initiated","Letter","Ohio, Kentucky, Pennsylvania","B-2346-13","Class II","Fresh Frozen Plasma","1613444, 1190847",".","2 units","Blood products, which were collected from a donor who traveled to a malarial endemic area, were distributed.",2/15/2006,"02/15/2006",9/18/2013,"09/18/2013"
"Biologics",41951,"Terminated","Hoxworth Blood Center University of Cincinnati Medical Center","Cincinnati","OH","US","Voluntary: Firm Initiated","Letter","Kentucky, Ohio.","B-1387-13","Class II","Red Blood Cells Leukocytes Reduced","1669388 (Part A)",,"1 unit","Blood products, collected from a donor taking the medication Azathioprine, were distributed.",2/22/2006,"02/22/2006",8/7/2013,"08/07/2013"
"Biologics",41951,"Terminated","Hoxworth Blood Center University of Cincinnati Medical Center","Cincinnati","OH","US","Voluntary: Firm Initiated","Letter","Kentucky, Ohio.","B-1388-13","Class II","Fresh Frozen Plasma","1669388 (Part B)",,"1 unit","Blood products, collected from a donor taking the medication Azathioprine, were distributed.",2/22/2006,"02/22/2006",8/7/2013,"08/07/2013"
"Biologics",41984,"Terminated","American Red Cross Blood Services","Saint Louis","MO","US","Voluntary: Firm Initiated","Telephone","Georgia","B-0172-13","Class II","Red Blood Cells","11FV46850",".","1 Unit","Blood product, collected from a donor who reported travel to a malarial endemic area, was distributed.",4/8/2006,"04/08/2006",2/27/2013,"02/27/2013"
"Biologics",42016,"Terminated","Tri-counties Blood Bank","Phoenix","AZ","US","Voluntary: Firm Initiated","Letter","California","B-1851-13","Class III","Red Blood Cells (Apheresis) Leukocytes Reduced","FZ66520; FZ66520",".","2 units","Blood products, quality control and distribution of products that did not meet specifications, were distributed. ",3/22/2006,"03/22/2006",8/28/2013,"08/28/2013"
"Biologics",42043,"Terminated","New York Blood Center, Inc.","New York","NY","US","Voluntary: Firm Initiated","Letter","New York, California","B-1316-13","Class II","Fresh Frozen Plasma","5353013",".","1 unit","Blood products, with unacceptable, undocumented, or incomplete product QC, were distributed. ",4/26/2006,"04/26/2006",6/5/2013,"06/05/2013"
"Biologics",42043,"Terminated","New York Blood Center, Inc.","New York","NY","US","Voluntary: Firm Initiated","Letter","New York, California","B-1315-13","Class II","Red Blood Cells","5353013",".","1 unit","Blood products, with unacceptable, undocumented, or incomplete product QC, were distributed. ",4/26/2006,"04/26/2006",6/5/2013,"06/05/2013"
"Biologics",42060,"Terminated","Tri-counties Blood Bank","San Luis Obispo","CA","US","Voluntary: Firm Initiated","Letter","CA","B-1852-13","Class III","Cryoprecipitated AHF, Pooled","LF38077; LF38078; LF38079; LF38080; LF38081; LF38082; LF38084; LF38085",".","8 units","Blood products, which were not frozen within 1 hour of production, were distributed. ",4/6/2006,"04/06/2006",8/28/2013,"08/28/2013"
"Biologics",42093,"Terminated","American Red Cross Blood Services","Saint Louis","MO","US","Voluntary: Firm Initiated","Telephone","Missouri; Saipan","B-0653-13","Class II","Plasma Frozen","011KV10514",,"1 Unit","Blood products, which were collected from a donor who traveled to a malarial endemic area, were distributed.",4/14/2006,"04/14/2006",3/20/2013,"03/20/2013"
"Biologics",42093,"Terminated","American Red Cross Blood Services","Saint Louis","MO","US","Voluntary: Firm Initiated","Telephone","Missouri; Saipan","B-0652-13","Class II","Red Blood Cells Leukocytes Reduced","011KV10514",,"1 Unit","Blood products, which were collected from a donor who traveled to a malarial endemic area, were distributed.",4/14/2006,"04/14/2006",3/20/2013,"03/20/2013"
"Biologics",42114,"Terminated","Siouxland Community Blood Bank","Sioux City","IA","US","Voluntary: Firm Initiated","Telephone","NC, FL","B-0654-13","Class III","Red Blood Cells Leukocytes Reduced","2046257(Part A); 2046257(Part B)",,"2 units","Blood products, collected from a donor without a documented result for body temperature, were distributed. ",4/25/2006,"04/25/2006",3/20/2013,"03/20/2013"
"Biologics",42157,"Terminated","Siouxland Community Blood Bank","Sioux City","IA","US","Voluntary: Firm Initiated","FAX","IA, Austria","B-0626-13","Class II","Blood and Blood Products for Reprocessing","2025841",,"1 unit","Blood products, collected from a donor considered to be at increased risk for variant Creutzfeldt-Jakob Disease (vCJD), were distributed. ",5/2/2006,"05/02/2006",3/6/2013,"03/06/2013"
"Biologics",42157,"Terminated","Siouxland Community Blood Bank","Sioux City","IA","US","Voluntary: Firm Initiated","FAX","IA, Austria","B-0625-13","Class II","Red Blood Cells Leukocytes Reduced","2025841",,"1 unit","Blood products, collected from a donor considered to be at increased risk for variant Creutzfeldt-Jakob Disease (vCJD), were distributed. ",5/2/2006,"05/02/2006",3/6/2013,"03/06/2013"
"Biologics",42160,"Terminated","Community Blood Bank, Inc.","Rancho Mirage","CA","US","Voluntary: Firm Initiated","Letter","CA","B-0040-14","Class II","Red Blood Cells Leukocytes Reduced","3531537",,"1","Blood product, collected from a donor who traveled to potential malaria endemic areas, was distributed",6/2/2006,"06/02/2006",12/18/2013,"12/18/2013"
"Biologics",42170,"Terminated","American Red Cross Blood Services","Wichita","KS","US","Voluntary: Firm Initiated","Letter","Kansas","B-0774-13","Class II","Red Blood Cells Leukocytes Reduced","02GG06978",,"1 Unit","Blood product, which was collected from a donor who traveled to a malarial endemic area, was distributed.",4/24/2006,"04/24/2006",4/3/2013,"04/03/2013"
"Biologics",42172,"Terminated","American Red Cross Blood Services","Wichita","KS","US","Voluntary: Firm Initiated","FAX","Kansas; Oklahoma","B-1625-13","Class II","Red Blood Cells Leukocytes Reduced","02LC64792 ;02LC68105 ;02LC72471",,"3 Units","Blood products, which were collected from a donor who traveled to a malarial endemic area, were distributed.",4/21/2006,"04/21/2006",7/3/2013,"07/03/2013"
"Biologics",42198,"Terminated","ZLB Bioplasma, Inc.","Boca Raton","FL","US","Voluntary: Firm Initiated","FAX","NC","B-1573-13","Class II","Source Plasma","0540484287; 0540483625; 0540483261; 0540482451; 0540482200; 0540481553; 0540481206",,"7 units","Blood products, collected from a donor with a history of incarceration, were distributed.",6/5/2006,"06/05/2006",8/7/2013,"08/07/2013"
"Biologics",42204,"Terminated","BioLife Plasma Services L.P.","Coralville","IA","US","Voluntary: Firm Initiated","FAX","Tennessee","B-1141-13","Class III","Source Plasma","02IIAA7720",,"1 Unit","Blood product, collected from a donor for whom donor suitability was not adequately determined, was distributed.",5/24/2006,"05/24/2006",5/22/2013,"05/22/2013"
"Biologics",42233,"Terminated","Siouxland Community Blood Bank","Sioux City","IA","US","Voluntary: Firm Initiated","Letter","IA, SC","B-0985-13","Class II","Red Blood Cells (Apheresis) Leukocytes Reduced","2026818(Part A); 2026818(Part B)",".","2 units","Blood products, which did not meet the acceptable product specifications, were distributed.",4/28/2006,"04/28/2006",4/24/2013,"04/24/2013"
"Biologics",42235,"Terminated","Siouxland Community Blood Bank","Sioux City","IA","US","Voluntary: Firm Initiated","Telephone","SD","B-0583-13","Class III","Red Blood Cells Leukocytes Reduced","2045397",".","1 unit","Blood product, stored at an unacceptable temperature, was distributed. ",5/1/2006,"05/01/2006",2/27/2013,"02/27/2013"
"Biologics",42243,"Terminated","Tri-counties Blood Bank","San Luis Obispo","CA","US","Voluntary: Firm Initiated","Letter","California","B-1853-13","Class III","Platelets Pheresis Leukocytes Reduced Irradiated","GW81381",".","1 unit","Blood product, during irradiation process was out of storage greater than 30 minutes, was distributed. ",6/9/2006,"06/09/2006",8/28/2013,"08/28/2013"
"Biologics",42261,"Terminated","Community Blood Center Of Gtr KC","Kansas City","MO","US","Voluntary: Firm Initiated","Telephone","Missouri","B-1704-13","Class III","Fresh Frozen Plasma","W045006024544; W045006015544",,"2 Units","Blood products, stored without continuous monitoring and possibly exposed to unacceptable temperatures, were distributed. ",6/1/2006,"06/01/2006",7/3/2013,"07/03/2013"
"Biologics",42261,"Terminated","Community Blood Center Of Gtr KC","Kansas City","MO","US","Voluntary: Firm Initiated","Telephone","Missouri","B-1705-13","Class III","Platelets Pheresis Leukocytes Reduced","W045006905629",,"1 Unit","Blood products, stored without continuous monitoring and possibly exposed to unacceptable temperatures, were distributed. ",6/1/2006,"06/01/2006",7/3/2013,"07/03/2013"
"Biologics",42325,"Terminated","Community Blood Centers of South Florida, Inc.","Lauderhill","FL","US","Voluntary: Firm Initiated","Telephone","FL","B-1166-13","Class III","Red Blood Cells","1718381",".","1 unit","Blood product, stored at the incorrect temperature, was distributed.",5/3/2006,"05/03/2006",5/29/2013,"05/29/2013"
"Biologics",42335,"Terminated","BloodNetUSA, Inc.","Lakeland","FL","US","Voluntary: Firm Initiated","FAX","Florida","B-1674-13","Class II","Red Blood Cells","6647950 and 6608685.",".","2","Blood products, collected from a donor who had traveled to a malarial endemic area, were distributed.",6/20/2006,"06/20/2006",7/17/2013,"07/17/2013"
"Biologics",42338,"Terminated","Octapharma Plasma Inc","San Diego","CA","US","Voluntary: Firm Initiated","FAX","Switzerland","B-0025-14","Class III","Source Plasma","YA182148",".","1 unit","Blood product, collected from a donor for whom donor suitability was not adequately determined, was distributed.",5/22/2006,"05/22/2006",12/4/2013,"12/04/2013"
"Biologics",42352,"Terminated","Hoxworth Blood Center University of Cincinnati Medical Center","Cincinnati","OH","US","Voluntary: Firm Initiated","Letter","Ohio.","B-1318-13","Class II","Fresh Frozen Plasma","1159239",".","1 unit","Blood products, which were collected from a donor who traveled to a malarial endemic area, were distributed. ",3/30/2006,"03/30/2006",6/5/2013,"06/05/2013"
"Biologics",42352,"Terminated","Hoxworth Blood Center University of Cincinnati Medical Center","Cincinnati","OH","US","Voluntary: Firm Initiated","Letter","Ohio.","B-1317-13","Class II","Red Blood Cells, Leukocyte Reduced","1159239",".","1 unit","Blood products, which were collected from a donor who traveled to a malarial endemic area, were distributed. ",3/30/2006,"03/30/2006",6/5/2013,"06/05/2013"
"Biologics",42386,"Terminated","American National Red Cross (The)","West Henrietta","NY","US","Voluntary: Firm Initiated","Telephone","Illinois, New York","B-1717-13","Class II","Red Blood Cells Leukocytes Reduced Irradiated","01KH99018",".","1","Blood products, collected from donors who traveled to potential malaria endemic areas, were distributed.",5/18/2006,"05/18/2006",7/17/2013,"07/17/2013"
"Biologics",42386,"Terminated","American National Red Cross (The)","West Henrietta","NY","US","Voluntary: Firm Initiated","Telephone","Illinois, New York","B-1716-13","Class II","Red Blood Cells Leukocytes Reduced","01KK22409; 01KK22414; 01KM36647; 01KM36670; ",".","4","Blood products, collected from donors who traveled to potential malaria endemic areas, were distributed.",5/18/2006,"05/18/2006",7/17/2013,"07/17/2013"
"Biologics",42386,"Terminated","American National Red Cross (The)","West Henrietta","NY","US","Voluntary: Firm Initiated","Telephone","Illinois, New York","B-1715-13","Class II","Platelets","01KH99185; 01KK22409; 01KK22422; 01KK22414; 01W28412; 01W28416; 01FW27321; 01KH99018; 01KH99164; 01KH99173; 01KK22425; 01Y68661; 01Y68675 01Y68678; 01Y68681; 01Y68689; 01Y68693; 01Y68695",".","18","Blood products, collected from donors who traveled to potential malaria endemic areas, were distributed.",5/18/2006,"05/18/2006",7/17/2013,"07/17/2013"
"Biologics",42406,"Terminated","San Diego Blood Bank","San Diego","CA","US","Voluntary: Firm Initiated","E-Mail","California","B-2090-13","Class III","Blood and Blood Products for Reprocessing","FM49257",,"1 unit","Blood products, collected from a donor in which donor suitability were not adequately determined, were distributed.",7/5/2006,"07/05/2006",9/4/2013,"09/04/2013"
"Biologics",42406,"Terminated","San Diego Blood Bank","San Diego","CA","US","Voluntary: Firm Initiated","E-Mail","California","B-2089-13","Class II","Red Blood Cells","FM49257",,"1 unit","Blood products, collected from a donor in which donor suitability were not adequately determined, were distributed.",7/5/2006,"07/05/2006",9/4/2013,"09/04/2013"
"Biologics",42435,"Terminated","American Red Cross Blood Services","Wichita","KS","US","Voluntary: Firm Initiated","Letter","Kansas","B-0775-13","Class II","Red Blood Cells Leukocytes Reduced","02GG11896",,"1 Unit","Blood product, which was collected from a donor who traveled to a malarial endemic area, was distributed.",5/27/2006,"05/27/2006",4/3/2013,"04/03/2013"
"Biologics",42437,"Terminated","Community Blood Bank, Inc.","Rancho Mirage","CA","US","Voluntary: Firm Initiated","Letter","CA.","B-2092-13","Class II","Red Blood Cells Leukocytes Reduced","3521967",,"1 unit","Blood products, collected from a donor who immigrated from a malarial endemic country, were distributed.",7/7/2006,"07/07/2006",10/23/2013,"10/23/2013"
"Biologics",42446,"Terminated","Department of the Air Force","Wright Patterson AFB","OH","US","Voluntary: Firm Initiated","FAX","New Jersey","B-1971-13","Class II","Red Blood Cells","W001606000743; W001606701171",,"2 units","Blood products, which were collected from a donor who traveled to a malarial endemic area, were distributed.",6/23/2006,"06/23/2006",8/7/2013,"08/07/2013"
"Biologics",42448,"Terminated","LifeServe Blood Center","Des Moines","IA","US","Voluntary: Firm Initiated","Letter","Iowa; Pennsylvania; CSL fractionator.","B-0201-13","Class III","Red Blood Cells","LX51298",".","1 Unit","Blood products, collected from a donor who disclosed taking Dapsone, were distributed. ",6/7/2006,"06/07/2006",1/16/2013,"01/16/2013"
"Biologics",42448,"Terminated","LifeServe Blood Center","Des Moines","IA","US","Voluntary: Firm Initiated","Letter","Iowa; Pennsylvania; CSL fractionator.","B-0203-13","Class III","Blood and Blood Products for Reprocessing","LX51298",".","1 Unit","Blood products, collected from a donor who disclosed taking Dapsone, were distributed. ",6/7/2006,"06/07/2006",1/16/2013,"01/16/2013"
"Biologics",42448,"Terminated","LifeServe Blood Center","Des Moines","IA","US","Voluntary: Firm Initiated","Letter","Iowa; Pennsylvania; CSL fractionator.","B-0202-13","Class III","Platelets Pooled Leukocytes Reduced","LP46813",".","1 Unit","Blood products, collected from a donor who disclosed taking Dapsone, were distributed. ",6/7/2006,"06/07/2006",1/16/2013,"01/16/2013"
"Biologics",42466,"Terminated","Florida Blood Services, Inc.","St Petersburg","FL","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Florida","B-1933-13","Class II","Red Blood Cells"," 4590944",,"1","Blood product, which was positive for E antigen was distributed to a recipient who was identified with an E antibody.",6/14/2006,"06/14/2006",7/31/2013,"07/31/2013"
"Biologics",42482,"Terminated","Biomat USA, Inc.","Phoenix","AZ","US","Voluntary: Firm Initiated","FAX","Spain","B-2416-13","Class II","Source Plasma","0230124137, 0230124642, 0230125300, 0230125851, 0230126581, 0230128020, 0230128531, 0230129104, 0230129657, 0230130244, 0230130860, 0230131470, 0230132051, 0230132569, 0230133157, 0230133666, 0230134222, 0230134805, 0230135449, 0230135976",,"20 units","Blood products, collected from a donor who received a piercing within 12 months of donation, were distributed.",6/2/2006,"06/02/2006",11/6/2013,"11/06/2013"
"Biologics",42482,"Terminated","Biomat USA, Inc.","Phoenix","AZ","US","Voluntary: Firm Initiated","FAX","Spain","B-2416-13","Class II","Source Plasma","0230124137, 0230124642, 0230125300, 0230125851, 0230126581, 0230128020, 0230128531, 0230129104, 0230129657, 0230130244, 0230130860, 0230131470, 0230132051, 0230132569, 0230133157, 0230133666, 0230134222, 0230134805, 0230135449, 0230135976",,"20 units","Blood products, collected from a donor who received a piercing within 12 months of donation, were distributed.",6/2/2006,"06/02/2006",11/6/2013,"11/06/2013"
"Biologics",42486,"Terminated","American National Red Cross (The)","Salt Lake City","UT","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Utah, Maryland, California.","B-0375-13","Class II","Red Blood Cells Leukocytes Reduced","020J 61790 , 020J 61792 , 020J 61796 , 020J 61797 , 020J 61799 , 020J 61801 , 020J 61804 , 020J 61607 , 020J 61811 , 020Q 10550 , 020Q 10551 , 020Q 10555 , 020Q 10556 , 020Q 10558 , 020Q 10562 , 020Q 10563 , 020Q 10564 , 020Q 10566, 020Q 10567, 020Q 10571 , 020Q 10574, 020Q 10575.",,"22 units","Blood products, which was collected in a manner that may have compromised the sterility of the collection system, were distributed.",6/14/2006,"06/14/2006",3/6/2013,"03/06/2013"
"Biologics",42486,"Terminated","American National Red Cross (The)","Salt Lake City","UT","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Utah, Maryland, California.","B-0374-13","Class II","Fresh Frozen Plasma","020Q 10574 , 020Q 10575.",,"2 units","Blood products, which was collected in a manner that may have compromised the sterility of the collection system, were distributed.",6/14/2006,"06/14/2006",3/6/2013,"03/06/2013"
"Biologics",42501,"Terminated","Community Blood Center of the Ozarks","Springfield","MO","US","Voluntary: Firm Initiated","Telephone","Missouri; Arkansas","B-0362-13","Class II","Red Blood Cells","8913268; 8913269; 8912432; 8912431",,"4 Units","Blood products, which tested positive for viral testing but incorrectly entered as negative, were distributed.",6/6/2006,"06/06/2006",2/13/2013,"02/13/2013"
"Biologics",42559,"Terminated","American National Red Cross","Portland","OR","US","Voluntary: Firm Initiated","Letter","California.","B-0573-13","Class II","Red Blood Cells Leukocytes Reduced","21GS28030.",".","1 component","Blood product, collected from a donor whose suitability to donate was not adequately determined, was distributed.",6/21/2006,"06/21/2006",2/27/2013,"02/27/2013"
"Biologics",42560,"Terminated","American National Red Cross (The)","Portland","OR","US","Voluntary: Firm Initiated","FAX","Oregon","B-0656-13","Class II","Platelets Pheresis Leukocytes Reduced","21LQ15939, 21LQ15947, 21LQ15950, 21LQ15953, 21LQ15971, 21LQ15992; 21LQ16025, 21LQ16027, 21LQ16042, 21LQ16043, 21LQ16062, 21LQ16064, 21LQ16122, 21LQ16167, 21LQ16190, 21LQ16215, 21LQ16299, 21LQ16314, 21LQ16336, 21LQ16351, 21LQ16446, 21LQ16462, 21LQ16520, 21LQ16530, 21LQ16546, 21LQ16633, 21LQ16648, 21LQ16249, 21LQ16635, 21LQ16637, 21LQ16642, 21LQ16222, 21LQ16305, 21LQ16529, 21LQ16542, 21LQ16552, 21LQ16174, 21LQ16020, 21LQ16186, 21LQ16302, 21LQ16602, 21LQ16113, 21LQ16073, 21LQ16076, 21LQ16137, 21LQ16161, 21LQ16304, 21LQ16084, 21LQ16328, 21LQ15970, 21LQ16028, 21LQ16121, 21LQ16271, 21LQ16291, 21LQ16400, 21LQ16244, 21LQ16625, 21LQ16173, 21LQ16327 21LQ15974",,"60 units","Blood products, which did not meet acceptable product specifications, were distributed.",11/9/2005,"11/09/2005",4/17/2013,"04/17/2013"
"Biologics",42560,"Terminated","American National Red Cross (The)","Portland","OR","US","Voluntary: Firm Initiated","FAX","Oregon","B-0657-13","Class II","Platelets Pheresis Leukocytes Reduced Irradiated","21LQ16150, 21LQ16030, 21LQ16044, 21LQ16076, 21LQ16078, 21LQ16082, 21LQ16179, 21LQ16310, 21LQ16368, 21LQ16501, 21LQ16542, 21LQ16616, 21LQ16623, 21LQ15970, 21LQ16118, 21LQ16598, 21LQ16634, 21LQ16275, 21LQ16637, 21LQ16013, 21LQ16111, 21LQ16142, 21LQ16177, 21LQ16585, 21LQ16593, 21LQ16107, 21LQ16324, 21LQ16450, 21LQ16168, 21LQ16197,21LQ16469",,"31 units","Blood products, which did not meet acceptable product specifications, were distributed.",11/9/2005,"11/09/2005",4/17/2013,"04/17/2013"
"Biologics",42577,"Terminated","International BioResources, LLC","El Paso","TX","US","Voluntary: Firm Initiated","FAX","NC","B-1167-13","Class II","Source Plasma","372020203; 372018910; 372018366; 372017462; 372028422; 372016374; 372014846; 372013772; 372013335; 372007234; 372000364; 372000335",".","12 units","Blood products, collected from a donor considered to be at increased risk for variant Creutzfeldt-Jakob Disease (vCJD), were distributed. ",7/7/2006,"07/07/2006",5/29/2013,"05/29/2013"
"Biologics",42579,"Terminated","International BioResources, LLC","El Paso","TX","US","Voluntary: Firm Initiated","FAX","NC","B-1155-13","Class II","Source Plasma","I65076717; I65070365",".","2 units","Blood product, collected from a donor considered to be at increased risk for variant Creutzfeldt-Jakob Disease (vCJD), was distributed. ",7/7/2006,"07/07/2006",5/29/2013,"05/29/2013"
"Biologics",42589,"Terminated","Tri-counties Blood Bank","Phoenix","AZ","US","Voluntary: Firm Initiated","Telephone","CA","B-1854-13","Class II","Red Blood Cells Leukocytes Reduced","042S19211",,"1 unit","Blood products, collected from a donor who traveled to an area considered endemic for malaria, were distributed.",8/4/2006,"08/04/2006",11/6/2013,"11/06/2013"
"Biologics",42589,"Terminated","Tri-counties Blood Bank","Phoenix","AZ","US","Voluntary: Firm Initiated","Telephone","CA","B-1854-13","Class II","Red Blood Cells (Apheresis) Leukocytes Reduced","FZ68866; LT17247; FZ69538",,"3 units","Blood products, which quality control and distribution of products did not meet specifications, were distributed. ",6/15/2006,"06/15/2006",11/6/2013,"11/06/2013"
"Biologics",42591,"Terminated","Tri-counties Blood Bank","San Luis Obispo","CA","US","Voluntary: Firm Initiated","Telephone","CA","B-1865-13","Class II","Red Blood Cells Leukocytes Reduced","GW84439",,"1 unit","Blood product, which did not have the required volume of red blood cells, was distributed.",6/14/2006,"06/14/2006",8/7/2013,"08/07/2013"
"Biologics",42599,"Terminated","Biomat USA, Inc.","Salt Lake City","UT","US","Voluntary: Firm Initiated","FAX","California","B-0322-13","Class II","Source Plasma","0630000144, 0630000390",".","2 units","Blood products, collected from a donor who received a piercing within one year of donation, were distributed.",6/21/2006,"06/21/2006",1/16/2013,"01/16/2013"
"Biologics",42601,"Terminated","Biomat USA, Inc.","Salt Lake City","UT","US","Voluntary: Firm Initiated","FAX","California","B-0323-13","Class II","Source Plasma","0630000313",".","1 unit","Blood product, collected from a donor who received a piercing within one year of donation, was distributed.",6/21/2006,"06/21/2006",1/16/2013,"01/16/2013"
"Biologics",42652,"Terminated","American Red Cross Blood Services","Saint Louis","MO","US","Voluntary: Firm Initiated","Telephone","Missouri","B-0717-13","Class II","Red Blood Cells Leukocytes Reduced Irradiated","011GF52924",".","1 Unit","Blood product, collected from a donor for whom the acceptance criteria for hematocrit was not met, was distributed.",6/30/2006,"06/30/2006",4/24/2013,"04/24/2013"
"Biologics",42667,"Terminated","LifeServe Blood Center","Des Moines","IA","US","Voluntary: Firm Initiated","Letter","NC; Switzerland","B-0921-13","Class III","Red Blood Cells Leukocytes Reduced","LT86807",".","1 unit","Blood products, collected from a donor with a history of surgery within the previous 12 months, were distributed.",2/19/2007,"02/19/2007",4/24/2013,"04/24/2013"
"Biologics",42671,"Terminated","LifeSouth Community Blood Centers, Inc.","Dunwoody","GA","US","Voluntary: Firm Initiated","Other","Georgia","B-0638-13","Class II","Platelets Pheresis Leukocytes Reduced","71X45517-7",,"1","Blood product, with a low platelet count, was distributed",7/10/2006,"07/10/2006",3/6/2013,"03/06/2013"
"Biologics",42697,"Terminated","Community Blood Center of the Ozarks","Springfield","MO","US","Voluntary: Firm Initiated","Letter","MO; AR; NJ","B-1688-13","Class III","Cryoprecipitated AHF","6541216;6568175; 6471644; 6500266; 4243041 ",".","5 Units","Blood products, manufactured from Whole Blood units with extended collection times, were distributed.",7/14/2006,"07/14/2006",7/10/2013,"07/10/2013"
"Biologics",42697,"Terminated","Community Blood Center of the Ozarks","Springfield","MO","US","Voluntary: Firm Initiated","Letter","MO; AR; NJ","B-1689-13","Class III","Platelets","6567735; 6554449; 6566610; 6488930; 6583196; 6471337; 6473459; 6487193; 6484513; 6504761; 6521015; 6617680; 6653373; 6708255; 4243318; 6617693; 6627057; 6517604; 6519075; 6518981; 6515638; 6487190; 6497614; 6464517; 6562334; 6477701; 6514649; 6692573; 6592478; 6661580; 6563569; 6559270; 6521050; 6497071",".","34 Units","Blood products, manufactured from Whole Blood units with extended collection times, were distributed.",7/14/2006,"07/14/2006",7/10/2013,"07/10/2013"
"Biologics",42697,"Terminated","Community Blood Center of the Ozarks","Springfield","MO","US","Voluntary: Firm Initiated","Letter","MO; AR; NJ","B-1690-13","Class III","Fresh Frozen Plasma","6562334; 6705196; 4243318; 6482869; 6497071; 6614538; 6496289; 6488930; 6559270; 6467217; 6524060; 6566610; 6582088; 6663526; 6476275; 6617680; 6610450; 6589186; 6464517; 6487193; 6547651; 6592478; 6473459; 6481957; 6495497; 6504761; 6517604; 6554011; 6565663; 6555912; 6567735; 6585224; 6697679; 6692573; 6570898; 6691603; 6617693; 6583196; 6477701; 6471337; 6708255 ",".","41 Units","Blood products, manufactured from Whole Blood units with extended collection times, were distributed.",7/14/2006,"07/14/2006",7/10/2013,"07/10/2013"
"Biologics",42697,"Terminated","Community Blood Center of the Ozarks","Springfield","MO","US","Voluntary: Firm Initiated","Letter","MO; AR; NJ","B-1692-13","Class III","Red Blood Cells Leukocytes Reduced Washed","6476878 ",".","1 Unit","Blood products, manufactured from Whole Blood units with extended collection times, were distributed.",7/14/2006,"07/14/2006",7/10/2013,"07/10/2013"
"Biologics",42697,"Terminated","Community Blood Center of the Ozarks","Springfield","MO","US","Voluntary: Firm Initiated","Letter","MO; AR; NJ","B-1691-13","Class III","Plasma Cryoprecipitate Reduced","6568175 ",".","1 Unit","Blood products, manufactured from Whole Blood units with extended collection times, were distributed.",7/14/2006,"07/14/2006",7/10/2013,"07/10/2013"
"Biologics",42701,"Terminated","BioLife Plasma Services L.P.","Van Nuys","CA","US","Voluntary: Firm Initiated","Telephone","California","B-1926-13","Class II","Source Plasma","06SUTA7770, 06SUTA7236, 06SUTA6923",".","3 units","Blood products, which were not quarantined after receiving information regarding a risk for variant Creutzfeldt-Jakob Disease (vCJD), were distributed.",8/24/2006,"08/24/2006",8/14/2013,"08/14/2013"
"Biologics",42729,"Terminated","Community Blood Center of the Ozarks","Springfield","MO","US","Voluntary: Firm Initiated","Telephone","MO","B-0938-13","Class II","Platelets Pheresis Leukocytes Reduced","9922637",".","1 unit","Blood product, which may have been unacceptable, was distributed.",7/7/2006,"07/07/2006",4/10/2013,"04/10/2013"
"Biologics",42731,"Terminated","Creative Testing Solutions","Tempe","AZ","US","Voluntary: Firm Initiated","Letter","AZ","B-1386-13","Class II","Red Blood Cells Leukocytes Reduced","106681705",,"1 unit","Blood product, in which routine testing was performed, interpreted and/or documented incorrectly, was distributed. ",7/13/2006,"07/13/2006",8/7/2013,"08/07/2013"
"Biologics",42750,"Terminated","Biomat USA, Inc.","Salt Lake City","UT","US","Voluntary: Firm Initiated","FAX","California","B-0324-13","Class II","Source Plasma","0630001318",".","1 unit","Blood product, collected from a donor who received a piercing within one year of donation, was distributed.",6/19/2006,"06/19/2006",1/16/2013,"01/16/2013"
"Biologics",42768,"Terminated","Community Blood Centers of South Florida, Inc.","Lauderhill","FL","US","Voluntary: Firm Initiated","Telephone","Florida","B-1385-13","Class III","Cryoprecipitated AHF","2109548",".","1 unit","Blood product was not frozen in required time, was distributed.",8/7/2006,"08/07/2006",6/19/2013,"06/19/2013"
"Biologics",42768,"Terminated","Community Blood Centers of South Florida, Inc.","Lauderhill","FL","US","Voluntary: Firm Initiated","Telephone","Florida","B-1385-13","Class III","Cryoprecipitated AHF","2109548",".","1 unit","Blood product was not frozen in required time, was distributed.",8/7/2006,"08/07/2006",8/28/2013,"08/28/2013"
"Biologics",42781,"Terminated","Florida Georgia Blood Alliance, Inc.","Jacksonville","FL","US","Voluntary: Firm Initiated","Letter","Georgia","B-0919-13","Class II","Red Blood Cells Leukocytes Reduced Washed"," 8315018",,"1 unit","Blood product, which was collected from a donor who traveled to malarial endemic area, was distributed",7/18/2006,"07/18/2006",4/17/2013,"04/17/2013"
"Biologics",42790,"Terminated","American National Red Cross (The)","West Henrietta","NY","US","Voluntary: Firm Initiated","FAX","New York","B-0041-13","Class II","Red Blood Cells (Apheresis)","01FH11831, 01FH13343, 01KK20799, 01KK22605, 01KK23536, 01KM37179, 01KX97207, 01Q92728",,"8 units","Blood products, which did not meet the minimum requirement for total hemoglobin, were distributed.",8/8/2006,"08/08/2006",3/13/2013,"03/13/2013"
"Biologics",42800,"Terminated","American National Red Cross (The)","Omaha","NE","US","Voluntary: Firm Initiated","FAX","Nebraska","B-0361-13","Class II","Platelets Pheresis Leukocytes Reduced","09LY02616(Part A) ;09LY02616(Part B)",".","2 units","Blood products, with unacceptable, undocumented or incomplete product QC and platelet counts were distributed. ",7/26/2006,"07/26/2006",1/30/2013,"01/30/2013"
"Biologics",42837,"Terminated","ZLB Bioplasma, Inc.","Boca Raton","FL","US","Voluntary: Firm Initiated","E-Mail","IL, IN","B-1981-13","Class II","Source Plasma","4020119034",,"1 unit","Blood product, collected from a donor, whose suitability to donate was not adequately determined, was distributed.",7/22/2006,"07/22/2006",8/7/2013,"08/07/2013"
"Biologics",42849,"Terminated","Ogden Medical Center, Inc.","Ogden","UT","US","Voluntary: Firm Initiated","Letter","UT","B-0579-13","Class II","Fresh Frozen Plasma","5625333",,"1 units","Donor Screening /incorrect ID used during deferral search, donor previously deferred due to testing.",6/21/2006,"06/21/2006",2/20/2013,"02/20/2013"
"Biologics",42849,"Terminated","Ogden Medical Center, Inc.","Ogden","UT","US","Voluntary: Firm Initiated","Letter","UT","B-0580-13","Class II","Red Blood Cells Leukocytes Reduced","5625333",,"1 unit","Donor Screening /incorrect ID used during deferral search, donor previously deferred due to testing.",6/21/2006,"06/21/2006",2/20/2013,"02/20/2013"
"Biologics",42877,"Terminated","Community Blood Center of the Ozarks","Springfield","MO","US","Voluntary: Firm Initiated","FAX","Austria","B-0204-13","Class II","Blood and Blood Products for Reprocessing","6702463",".","1 Unit","Blood product, collected from a donor who was at risk for variant Creutzfeldt-Jakob disease (vCJD), was distributed.",7/28/2006,"07/28/2006",1/16/2013,"01/16/2013"
"Biologics",42883,"Terminated","Community Blood Bank of Lancaster County Medical Society","Lincoln","NE","US","Voluntary: Firm Initiated","FAX","NY","B-0272-13","Class II","Red Blood Cells Leukocytes Reduced","9121046",".","1 unit","Blood products, which were collected from a donor who traveled to a malarial endemic area, were distributed. ",8/8/2006,"08/08/2006",1/2/2013,"01/02/2013"
"Biologics",42908,"Terminated","American National Red Cross (The)","Omaha","NE","US","Voluntary: Firm Initiated","FAX","NE; MA","B-1282-13","Class II","Red Blood Cells Leukocytes Reduced","09FF59678; 09FV14394; 09FV19303; 09FF56660",".","4 Units","Blood products, collected from a donor who traveled to a malarial endemic area, were distributed.",9/8/2006,"09/08/2006",7/10/2013,"07/10/2013"
"Biologics",42935,"Terminated","Tri-counties Blood Bank","San Luis Obispo","CA","US","Voluntary: Firm Initiated","Letter","CA","B-1890-13","Class II","Red Blood Cells Leukocytes Reduced Irradiated","T28221; T28223; LT13552; KH00896; GW77721; FZ63465",,"6 units","Blood products, with discrepancies documented on the irradiator worksheet, were documented. ",10/16/2006,"10/16/2006",9/4/2013,"09/04/2013"
"Biologics",42935,"Terminated","Tri-counties Blood Bank","San Luis Obispo","CA","US","Voluntary: Firm Initiated","Letter","CA","B-1889-13","Class II","Platelets Pheresis Leukocytes Reduced Irradiated","GW76846, GW77802, GW77774, GW76276, GW76976, LF96430, GW75184 GW71105, LF41595, LF44579, GW70944 ",,"11 units","Blood products, with discrepancies documented on the irradiator worksheet, were documented. ",10/16/2006,"10/16/2006",9/4/2013,"09/04/2013"
"Biologics",42952,"Terminated","Florida Blood Services, Inc.","Pensacola","FL","US","Voluntary: Firm Initiated","Telephone","Alabama, Florida","B-0952-13","Class III","Platelets Pheresis Leukocytes Reduced Irradiated","4922809",,"1 unit","Blood products, which may have been exposed to unacceptable temperature during storage, were distributed.",8/30/2006,"08/30/2006",4/17/2013,"04/17/2013"
"Biologics",42952,"Terminated","Florida Blood Services, Inc.","Pensacola","FL","US","Voluntary: Firm Initiated","Telephone","Alabama, Florida","B-0953-13","Class III","Platelets Pheresis Leukocytes Reduced","4922805",,"1 unit","Blood products, which may have been exposed to unacceptable temperature during storage, were distributed.",8/30/2006,"08/30/2006",4/17/2013,"04/17/2013"
"Biologics",42954,"Terminated","American National Red Cross (The)","Boise","ID","US","Voluntary: Firm Initiated","Telephone","Utah.","B-0671-13","Class III","Red Blood Cells Leukocytes Reduced","020LZ30286; 020LH19466.",".","2 components","Blood products, which may have been exposed to unacceptable temperatures during storage, were distributed.",7/28/2006,"07/28/2006",3/27/2013,"03/27/2013"
"Biologics",42956,"Terminated","American National Red Cross","Boise","ID","US","Voluntary: Firm Initiated","Telephone","Oklahoma, Texas","B-0797-13","Class II","Red Blood Cells Leukocytes Reduced","020X 25176.",,"1 unit","Blood product, which was collected from a donor in which donor suitability was not adequately determined, was distributed.",8/23/2006,"08/23/2006",4/3/2013,"04/03/2013"
"Biologics",43004,"Terminated","LifeServe Blood Center","Des Moines","IA","US","Voluntary: Firm Initiated","Letter","Ilinois","B-0742-13","Class II","Red Blood Cells","LX28135",,"1 Unit","Blood product, which was collected from a donor who traveled to a malarial endemic area, was distributed. ",9/27/2006,"09/27/2006",3/13/2013,"03/13/2013"
"Biologics",43008,"Terminated","American National Red Cross (The)","West Henrietta","NY","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","New York","B-0741-13","Class II","Platelets Pheresis Leukocytes Reduced","01FP43191",,"1","Blood product, which did not meet acceptable product specifications, was distributed.",8/17/2006,"08/17/2006",3/13/2013,"03/13/2013"
"Biologics",43037,"Terminated","International BioResources, LLC","Colorado Springs","CO","US","Voluntary: Firm Initiated","E-Mail","NC","B-0305-13","Class II","Source Plasma","366020863; 366020554; 366009883; 366009338; 366008981; 366007812; 366007488; 366006391; 366006082; 366004975; 366004698; 366000802; 366000830",".","13 units","Blood products, collected from a donor who was at risk for variant Creutzfeldt-Jakob disease (vCJD), were distributed.",9/1/2006,"09/01/2006",1/2/2013,"01/02/2013"
"Biologics",43051,"Terminated","BioLife Plasma Services L.P.","Springfield","MO","US","Voluntary: Firm Initiated","Letter","IL","B-0828-13","Class III","Source Plasma","06FMOC2639; 06FMOC1026; 06FMOC0919; 06FMOC1518; 06FMOB8512; 06FMOC0513; 06FMOC3453; 06FMOB7547; 06FMOC0910; 06FMOC3177; 06FMOB9611; 06FMOC0477",".","12 units","Blood products, collected from donors whose donor suitability was not adequately determined, were distributed.",8/29/2006,"08/29/2006",4/10/2013,"04/10/2013"
"Biologics",43057,"Terminated","International BioResources, LLC","Research Triangle Park","NC","US","Voluntary: Firm Initiated","Letter","North Carolina","B-2160-13","Class III","Source Plasma","368010172",".","1","Blood product, collected from a donor whose arm check and general appearance inspection were not documented, was distributed.",9/14/2006,"09/14/2006",10/2/2013,"10/02/2013"
"Biologics",43063,"Terminated","Community Blood Bank, Inc.","Rancho Mirage","CA","US","Voluntary: Firm Initiated","Letter","CA.","B-2262-13","Class II","Red Blood Cells Leukocytes Reduced Irradiated","3537422",,"1 unit","Blood products, collected from a donor with a history of Hepatitis, were distributed.",10/13/2006,"10/13/2006",9/25/2013,"09/25/2013"
"Biologics",43063,"Terminated","Community Blood Bank, Inc.","Rancho Mirage","CA","US","Voluntary: Firm Initiated","Letter","CA.","B-2261-13","Class II","Red Blood Cells Leukocytes Reduced","3532823",,"1 unit","Blood products, collected from a donor with a history of Hepatitis, were distributed.",10/13/2006,"10/13/2006",9/25/2013,"09/25/2013"
"Biologics",43063,"Terminated","Community Blood Bank, Inc.","Rancho Mirage","CA","US","Voluntary: Firm Initiated","Letter","CA.","B-2260-13","Class II","Fresh Frozen Plasma","3532823; 3537422",,"2 units","Blood products, collected from a donor with a history of Hepatitis, were distributed.",10/13/2006,"10/13/2006",9/25/2013,"09/25/2013"
"Biologics",43075,"Terminated","American Red Cross Blood Services","Saint Louis","MO","US","Voluntary: Firm Initiated","Telephone","Missouri","B-0634-13","Class II","Red Blood Cells Leukocytes Reduced","11KS13328",,"1 Unit","Blood product, which was collected from a donor who traveled to a malarial endemic area, was distributed",8/24/2006,"08/24/2006",3/6/2013,"03/06/2013"
"Biologics",43097,"Terminated","American National Red Cross","Toledo","OH","US","Voluntary: Firm Initiated","Telephone","Nationwide","B-0134-14","Class III","Red Blood Cells Leukocytes Reduced","50X32932, 50X32933, 50X32936, 50X32937, 50X32938, 50X32939, 50X32940, 50X32941, 50X32942, 50X32945, 50X32946",,"11 units","Blood products, collected using a scale for which the quality control results were not documented, were distributed.",8/8/2006,"08/08/2006",12/18/2013,"12/18/2013"
"Biologics",43103,"Terminated","American National Red Cross (The)","Cleveland","OH","US","Voluntary: Firm Initiated","Telephone","Ohio, Virginia","B-2406-13","Class II","Platelets Leukocytes Reduced","042S19211",,"1 unit","Blood products, collected from a donor who traveled to an area considered endemic for malaria, were distributed.",8/4/2006,"08/04/2006",11/6/2013,"11/06/2013"
"Biologics",43103,"Terminated","American National Red Cross (The)","Cleveland","OH","US","Voluntary: Firm Initiated","Telephone","Ohio, Virginia","B-2406-13","Class II","Platelets Leukocytes Reduced","042S19211",,"1 unit","Blood products, collected from a donor who traveled to an area considered endemic for malaria, were distributed.",11/21/2006,"11/21/2006",11/6/2013,"11/06/2013"
"Biologics",43103,"Terminated","American National Red Cross (The)","Cleveland","OH","US","Voluntary: Firm Initiated","Telephone","Ohio, Virginia","B-2405-13","Class II","Red Blood Cells Leukocytes Reduced","042S19211",,"1 unit","Blood products, collected from a donor who traveled to an area considered endemic for malaria, were distributed.",8/4/2006,"08/04/2006",11/6/2013,"11/06/2013"
"Biologics",43109,"Terminated","Presbyterian Intercommunity Hospital, Inc. Blood Bank","Whittier","CA","US","Voluntary: Firm Initiated","Letter","CA","B-2194-13","Class II","Red Blood Cells","00P64464 ",,"1 unit","Blood product, which was collected from a donor in which donor suitability was not adequately determined, was distributed.",12/12/2012,"12/12/2012",8/21/2013,"08/21/2013"
"Biologics",43113,"Terminated","Presbyterian Intercommunity Hospital, Inc. Blood Bank","Whittier","CA","US","Voluntary: Firm Initiated","Letter","CA","B-2195-13","Class II","Red Blood Cells","3593908",,"1 unit","Blood product, which was collected from a donor in which donor suitability was not adequately determined, was distributed.",12/12/2012,"12/12/2012",8/21/2013,"08/21/2013"
"Biologics",43117,"Terminated","Presbyterian Intercommunity Hospital, Inc. Blood Bank","Whittier","CA","US","Voluntary: Firm Initiated","Letter","CA","B-2279-13","Class III","Fresh Frozen Plasma","5304596",".","1 unit","Blood product, collected from a donor for whom donor suitability was not adequately determined, was distributed.",12/12/2012,"12/12/2012",9/11/2013,"09/11/2013"
"Biologics",43119,"Terminated","Presbyterian Intercommunity Hospital, Inc. Blood Bank","Whittier","CA","US","Voluntary: Firm Initiated","Letter","California","B-2239-13","Class III","Fresh Frozen Plasma","3593691",".","1 unit","Blood product, collected from a donor for whom donor suitability was not adequately determined, was distributed.",12/12/2012,"12/12/2012",9/11/2013,"09/11/2013"
"Biologics",43121,"Terminated","Presbyterian Intercommunity Hospital, Inc. Blood Bank","Whittier","CA","US","Voluntary: Firm Initiated","Letter","California","B-2240-13","Class III","Fresh Frozen Plasma","5304297",".","1 unit","Blood product, collected from a donor for whom donor suitability was not adequately determined, was distributed.",12/12/2012,"12/12/2012",9/11/2013,"09/11/2013"
"Biologics",43129,"Terminated","Tri-counties Blood Bank","San Luis Obispo","CA","US","Voluntary: Firm Initiated","Telephone","California","B-1866-13","Class II","Platelets Pheresis Leukocytes Reduced Irradiated","GW90414",,"1 unit","Blood product, which did not meet the acceptable product specifications, was distributed. ",9/3/2006,"09/03/2006",8/7/2013,"08/07/2013"
"Biologics",43152,"Terminated","American Red Cross Blood Services","Saint Louis","MO","US","Voluntary: Firm Initiated","Telephone","Missouri","B-0633-13","Class II","Red Blood Cells Leukocytes Reduced","11FY34707",,"1","Blood product, which was collected from a donor in which donor suitability was not adequately determined, was distributed.",8/15/2006,"08/15/2006",3/6/2013,"03/06/2013"
"Biologics",43171,"Terminated","Presbyterian Intercommunity Hospital, Inc. Blood Bank","Whittier","CA","US","Voluntary: Firm Initiated","Telephone","CA","B-2033-13","Class II","Fresh Frozen Plasma","3594412 ",".","1 unit","Blood product, collected from a donor who was at risk for variant Creutzfeldt-Jakob Disease (vCJD), was distributed.",5/5/2008,"05/05/2008",8/14/2013,"08/14/2013"
"Biologics",43176,"Terminated","American National Red Cross (The)","Pomona","CA","US","Voluntary: Firm Initiated","Letter","CA","B-2083-13","Class III","Red Blood Cells","084GS72263",,"1 unit","Blood products, collected from a donor for whom there was no documentation of an arm inspection, were distributed.",11/3/2006,"11/03/2006",11/27/2013,"11/27/2013"
"Biologics",43179,"Terminated","Presbyterian Intercommunity Hospital, Inc. Blood Bank","Whittier","CA","US","Voluntary: Firm Initiated","Letter","California","B-2246-13","Class III","Fresh Frozen Plasma","3595085 ",".","1 unit","Blood product, collected from a donor for whom donor suitability was not adequately determined, was distributed.",12/12/2012,"12/12/2012",9/11/2013,"09/11/2013"
"Biologics",43182,"Terminated","Presbyterian Intercommunity Hospital, Inc. Blood Bank","Whittier","CA","US","Voluntary: Firm Initiated","Letter","California","B-2245-13","Class III","Fresh Frozen Plasma","3593691 ",".","1 unit","Blood product, collected from a donor for whom donor suitability was not adequately determined, was distributed.",12/12/2012,"12/12/2012",9/11/2013,"09/11/2013"
"Biologics",43196,"Terminated","ZLB Bioplasma, Inc.","Albuquerque","NM","US","Voluntary: Firm Initiated","FAX","NC, IL","B-0598-13","Class III","Source Plasma","0340806896;0340798958;0340794087;0340787525;0340786632;0340785906;0340784935;0340784713;0340666228;70883794;70878455",,"11 units","Blood products, collected from a donor who was previously deferred by another donor center, were distributed. ",9/6/2006,"09/06/2006",2/20/2013,"02/20/2013"
"Biologics",43197,"Terminated","Blood Bank of San Bernardino and Riverside Counties","San Bernardino","CA","US","Voluntary: Firm Initiated","Telephone","California","B-2196-13","Class II","Red Blood Cells Leukocytes Reduced","GP53054",,"1 unit","Blood product, which was not quarantined after the donor provided information of a possible blood exposure, was distributed.",9/26/2006,"09/26/2006",9/4/2013,"09/04/2013"
"Biologics",43225,"Terminated","ZLB Bioplasma, Inc.","Aurora","CO","US","Voluntary: Firm Initiated","FAX","NC, Switzerland, Germany","B-0597-13","Class II","Source Plasma","7020524501;7020522849;7020522124;7020521262;7020520024;7020519462;7020517997;7020517603;7020505336;7020504561;7020503796;7020502939;7020502171;7020500585;7020499830;7020499053;7020498231",,"17 units","Blood products, collected from a donor who did not have a complete physical examination, were distributed.",9/22/2006,"09/22/2006",2/20/2013,"02/20/2013"
"Biologics",43239,"Terminated","Community Blood Bank of Lancaster County Medical Society","Lincoln","NE","US","Voluntary: Firm Initiated","FAX","NJ","B-0271-13","Class II","Red Blood Cells Leukocytes Reduced","9122839",".","1 unit","Blood product, which was collected from a donor who traveled to a malarial endemic area, was distributed.",9/21/2006,"09/21/2006",1/2/2013,"01/02/2013"
"Biologics",43282,"Terminated","Southern California Permanente Medical Group Blood Donor Center","Irvine","CA","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","CA","B-1685-13","Class II","Fresh Frozen Plasma","KX01047",".","1 unit","Blood products, which were collected from an unsuitable donor based on risk factors for variant Creutzfeldt-Jakob Disease (vCJD), were distributed. ",10/2/2006,"10/02/2006",9/11/2013,"09/11/2013"
"Biologics",43282,"Terminated","Southern California Permanente Medical Group Blood Donor Center","Irvine","CA","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","CA","B-1684-13","Class II","Red Blood Cells","KX01047",".","1 unit","Blood products, which were collected from an unsuitable donor based on risk factors for variant Creutzfeldt-Jakob Disease (vCJD), were distributed. ",10/2/2006,"10/02/2006",9/11/2013,"09/11/2013"
"Biologics",43300,"Terminated","Mississippi Valley Reg Bld Ctr","Davenport","IA","US","Voluntary: Firm Initiated","FAX","IL, PA, IA, MS, MO","B-0328-13","Class II","Cryoprecipitated AHF","GX06871, GX06874",".","2 units","Blood products, collected from donors whose arm scrubs were performed using expired cleanser, were distributed.",10/2/2006,"10/02/2006",2/27/2013,"02/27/2013"
"Biologics",43300,"Terminated","Mississippi Valley Reg Bld Ctr","Davenport","IA","US","Voluntary: Firm Initiated","FAX","IL, PA, IA, MS, MO","B-0329-13","Class II","Red Blood Cells Leukocytes Reduced","GX06872, GX06874, GX06873, GX06870, GX06868, GX06865, GX06864, GX06869, GX06866, GX06878, GX06871",".","11 units","Blood products, collected from donors whose arm scrubs were performed using expired cleanser, were distributed.",10/2/2006,"10/02/2006",2/27/2013,"02/27/2013"
"Biologics",43312,"Terminated","BloodNetUSA, Inc.","Lakeland","FL","US","Voluntary: Firm Initiated","FAX","Switzerland and FL","B-1231-13","Class III","Red Blood Cells","6303489",,"1 unit","Blood product, collected from a donor whose arm inspection was not performed, was distributed.",10/24/2006,"10/24/2006",5/22/2013,"05/22/2013"
"Biologics",43312,"Terminated","BloodNetUSA, Inc.","Lakeland","FL","US","Voluntary: Firm Initiated","FAX","Switzerland and FL","B-1232-13","Class III","Blood and Blood Products for Reprocessing","6303489",,"1 unit","Blood product, collected from a donor whose arm inspection was not performed, was distributed.",10/24/2006,"10/24/2006",5/22/2013,"05/22/2013"
"Biologics",43318,"Terminated","International BioResources, LLC","Fort Worth","TX","US","Voluntary: Firm Initiated","FAX","NC","B-0402-13","Class III","Source Plasma","363016064",,"1 unit","Blood product, collected from a donor, whose suitability to donate was not adequately determined, was distributed.",10/19/2006,"10/19/2006",2/20/2013,"02/20/2013"
"Biologics",43331,"Terminated","Community Blood Center of the Ozarks","Springfield","MO","US","Voluntary: Firm Initiated","Letter","MO and Austria","B-0599-13","Class II","Red Blood Cells","6731320",,"1 unit","Blood product, which was collected from a donor who traveled to a malarial endemic area, was distributed.",11/8/2006,"11/08/2006",2/20/2013,"02/20/2013"
"Biologics",43350,"Terminated","BioLife Plasma Services L.P.","Springfield","MO","US","Voluntary: Firm Initiated","FAX","CA","B-0398-13","Class II","Source Plasma","06FMOC6067; 06FMOC5647",,"2 units","Blood products, which were collected from a donor with a history of multiple high risk behaviors, were distributed.",10/27/2006,"10/27/2006",2/13/2013,"02/13/2013"
"Biologics",43372,"Terminated","Baylor University Medical Center - Transfusion Service Center","Dallas","TX","US","Voluntary: Firm Initiated","Telephone","TX","B-0363-13","Class II","Red Blood Cells Leukocytes Reduced Irradiated","49GN54061",".","1 unit","Blood product, labeled with an incorrect expiration date, was distributed.",10/10/2006,"10/10/2006",1/23/2013,"01/23/2013"
"Biologics",43378,"Terminated","Cedars-Sinai Medical Center","West Hollywood","CA","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","CA.","B-2349-13","Class II","Platelets","Q33179/1, Q34253/1, Q35248/1, Q37672/1",,"4 units","Blood products, collected from a donor who was previously deferred, were distributed.",11/18/2006,"11/18/2006",10/23/2013,"10/23/2013"
"Biologics",43378,"Terminated","Cedars-Sinai Medical Center","West Hollywood","CA","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","CA.","B-2350-13","Class II","Salvaged Plasma for Non-Injectables","J04852/2, M19247/1, M20753/1, M22181/1, M24146/1, N26282/1, N28776/1, Q36267/2, R39866/1, S45532/1, N87396/1, N94495/1",,"12 units","Blood products, collected from a donor who was previously deferred, were distributed.",11/18/2006,"11/18/2006",10/23/2013,"10/23/2013"
"Biologics",43462,"Terminated","American National Red Cross (The)","Salt Lake City","UT","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Philadelphia, Idaho.","B-0955-13","Class II","Platelets Pheresis Leukocytes Reduced","020P32286; 020P32289",,"2 units","Blood products, which did not meet acceptable product specifications, were distributed.",9/8/2006,"09/08/2006",4/17/2013,"04/17/2013"
"Biologics",43506,"Terminated","Tri-counties Blood Bank","Phoenix","AZ","US","Voluntary: Firm Initiated","Telephone","California","B-1867-13","Class III","Red Blood Cells (Apheresis) Leukocytes Reduced","LT22661",,"1 unit","Blood product, which was outside the acceptable quality control ranges, was distributed. ",10/18/2006,"10/18/2006",8/7/2013,"08/07/2013"
"Biologics",43553,"Terminated","Central Kentucky Blood Center Inc","Lexington","KY","US","Voluntary: Firm Initiated","Letter","Kentucky","B-1980-13","Class II","Red Blood Cells Leukocytes Reduced","2311657 (Part B)",,"1 unit","Blood products, which were collected from a donor who traveled to a malarial endemic area, were distributed.",12/4/2006,"12/04/2006",8/7/2013,"08/07/2013"
"Biologics",43614,"Terminated","ZLB Bioplasma, Inc.","Albuquerque","NM","US","Voluntary: Firm Initiated","FAX","IL, NC","B-0600-13","Class III","Source Plasma","0340763587;0340762865;;0340765547",,"3 units","Blood products, collected from a donor who was previously deferred due to testing, were distributed.",12/7/2006,"12/07/2006",2/20/2013,"02/20/2013"
"Biologics",43624,"Terminated","Blood Bank Of San Bernardino And Riverside Counties","San Bernardino","CA","US","Voluntary: Firm Initiated","Letter","CA, Austria","B-1979-13","Class II","Red Blood Cells Leukocytes Reduced Irradiated","GP20788",,"1 unit","Blood products, collected from a donor who warranted deferral due to travel to a malaria endemic area, were distributed.",11/20/2006,"11/20/2006",8/7/2013,"08/07/2013"
"Biologics",43663,"Terminated","American National Red Cross (The)","Columbus","OH","US","Voluntary: Firm Initiated","Letter","OH","B-2337-13","Class II","Red Blood Cells (Apheresis) Leukocytes Reduced","16GK11041(Part A); 16GK11041(Part B)",,"2 units","Blood products, in which quality control and distribution of products did not meet specifications, were distributed.",10/19/2006,"10/19/2006",9/25/2013,"09/25/2013"
"Biologics",43672,"Terminated","PlasmaCare Inc","Columbus","OH","US","Voluntary: Firm Initiated","FAX","OH","B-2009-13","Class II","Source Plasma","2040055458, 2040053823, 2040052644",".","3 units","Blood products, collected from a donor who did not have a complete physical examination, were distributed.",10/14/2006,"10/14/2006",8/28/2013,"08/28/2013"
"Biologics",43678,"Terminated","American National Red Cross","Portland","OR","US","Voluntary: Firm Initiated","Letter","Oregon.","B-0732-13","Class II","Red Blood Cells Leukocytes Reduced","021LL14609.",,"1 component","Blood product, collected from a donor who lived in a country endemic for malaria, was distributed. .",10/17/2006,"10/17/2006",3/13/2013,"03/13/2013"
"Biologics",43691,"Terminated","American Red Cross Blood Services","Omaha","NE","US","Voluntary: Firm Initiated","Letter","CO; NE; PA; IA; MA; TX; NY; IL; ME; MI","B-1262-13","Class II","Red Blood Cells Leukocytes Reduced","009FK67524;009GH72357;009GX55678;009FK67528; 009GH72361;009GX56251;009FK67530;009GH72370; 009GX56253;009FK67532;009GH72371;009GX56256; 009FK67534;009GH72378;009GX56261;009FK67536; 009GH72383;009GX56262;009FK67541;009GJ72636; 009GX56265;009FK67544;009GJ72641;009GX56270; 009FK67548;009GJ72645;009GX56272;009FK67551; 009GJ72648;009GX56275;009FK67555;009GJ72650; 009KG34257;009FK67557;009GJ72652;009KG34261; 009FK67559;009GJ72657;009KG34265;009FK67562; 009GJ73151;009KG34850;009FK67565;009GJ73154; 009KG34855;009FK68014;009GJ73161;009KG34856; 009FK68021;009GJ73179;009KG34862;009FV21440; 009GJ73189;009KG34878;009FV21442;009GJ73195; 009KG34883;009FV21445;009GJ73196;009KG34890; 009FV21498;009GJ73204;009KG34894;009FV21660; 009GJ73444;009KG34897;009FV21661;009GJ73447; 009KG35556;009FV21663;009GJ73453;009KG35561; 009FV21664;009GJ73458;009KG35570;009FV21666; 009GJ73465;009KG35574;009FV21667;009GJ74325; 009KG35577;009FV21671;009GJ74331;009KG35592; 009FV21674;009GJ74337;009KG35596;009FV21675; 009GJ74342;009KG35601;009FV21679;009GJ74408; 009KG35605;009FV21682;009GJ74533;009KG35610; 009FV22236;009GJ74538;009KG35614;009FV22237; 009GJ74547;009KG35615;009FV22239;009GJ74552; 009KG35724;009FV22242;009GJ74556;009KG35726; 009FV22243;009GJ74570;009KG35728;009FV22246; 009GJ74577;009KG35731;009FV22248;009GJ74589; 009KG35734;009FV22253;009GJ74580;009KG35735; 009FV22254;009GJ74583;009KG35738;009FV22255; 009GJ74592;009KG35740;009FV22257;009GJ74598; 009KG35742;009FV22258;009GJ74600;009KG35753; 009FV22261;009GJ74635;009KG35754;009FV22262; 009GJ74641;009KG35758;009FV22265;009GJ74645; 009KG35761;009FV22266;009GJ74647;009KG35763; 009FV22268;009GJ74650;009KG35767;009FV22270; 009GJ74652;009KG35892;009FV23223;009GJ74655; 009KG35905;009FV23234;009GJ74676;009KG35912; 009FV23244;009GJ74680;009KG35949;009FV23247; 009GJ74681;009KG35951;009FV23614;009GJ74683; 009KG35956;009FV23615;009GJ74687;009KG35961; 009FV23622;009GJ74688;009KG35962;009FV23623; 009GJ74691;009KG36778;009",".","306 Units","Blood products, which were collected in a manner that may have compromised the sterility of the collection system, were distributed.",11/10/2006,"11/10/2006",6/5/2013,"06/05/2013"
"Biologics",43691,"Terminated","American Red Cross Blood Services","Omaha","NE","US","Voluntary: Firm Initiated","Letter","CO; NE; PA; IA; MA; TX; NY; IL; ME; MI","B-1264-13","Class II","Fresh Frozen Plasma","009GJ74600;009GJ74577;009GJ74645;009GJ74647; 009GJ74650 ",".","5 Units","Blood products, which were collected in a manner that may have compromised the sterility of the collection system, were distributed.",11/10/2006,"11/10/2006",6/5/2013,"06/05/2013"
"Biologics",43691,"Terminated","American Red Cross Blood Services","Omaha","NE","US","Voluntary: Firm Initiated","Letter","CO; NE; PA; IA; MA; TX; NY; IL; ME; MI","B-1263-13","Class II","Red Blood Cells Leukocytes Reduced Irradiated","009FK68018;009FZ57830;009FZ57863;009GH71412; 009GH72251;009GR04642;009GR04883;009GR04885; 009KG34879;009KG35535;009KG35620;009KG35621; 009KG35897;009KG35920;009Q87158;009Q88411 ",".","16 Units","Blood products, which were collected in a manner that may have compromised the sterility of the collection system, were distributed.",11/10/2006,"11/10/2006",6/5/2013,"06/05/2013"
"Biologics",43710,"Terminated","American Red Cross Blood Services","Wichita","KS","US","Voluntary: Firm Initiated","FAX","KS and CA","B-0435-13","Class II","Red Blood Cells Leukocytes Reduced","02GG13901",".","1 unit","Blood products, which were collected from a donor in which donor suitability was not adequately determined, were distributed.",11/8/2006,"11/08/2006",2/6/2013,"02/06/2013"
"Biologics",43710,"Terminated","American Red Cross Blood Services","Wichita","KS","US","Voluntary: Firm Initiated","FAX","KS and CA","B-0436-13","Class III","Blood and Blood Products for Reprocessing","02GG13901",".","1 unit","Blood products, which were collected from a donor in which donor suitability was not adequately determined, were distributed.",11/8/2006,"11/08/2006",2/6/2013,"02/06/2013"
"Biologics",43747,"Terminated","Southern California Permanente Medical Group Blood Donor Center","Los Angeles","CA","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","CA","B-1679-13","Class III","Red Blood Cells","KP29367",".","1 unit","Blood product, collected from a donor who did not meet acceptance criteria, was distributed. ",11/30/2006,"11/30/2006",9/11/2013,"09/11/2013"
"Biologics",43768,"Terminated","BioLife Plasma Services L.P.","Van Nuys","CA","US","Voluntary: Firm Initiated","Telephone","California","B-1477-13","Class II","Source Plasma","05CILB7848",,"1 unit","Blood product, which tested negative for viral markers, but was collected from a donor who subsequently tested positive for hepatitis B surface antigen (HBsAg), was distributed.",1/4/2007,"01/04/2007",8/7/2013,"08/07/2013"
"Biologics",43785,"Terminated","American Red Cross Blood Services","Saint Louis","MO","US","Voluntary: Firm Initiated","Telephone","Illinois","B-0601-13","Class II","Red Blood Cells Leukocytes Reduced","11KF19438",,"1 Unit","Blood product, collected from a donor who was previously deferred, was distributed.",10/24/2006,"10/24/2006",2/20/2013,"02/20/2013"
"Biologics",43815,"Terminated","San Diego Blood Bank","San Diego","CA","US","Voluntary: Firm Initiated","Letter","California","B-2336-13","Class II","Red Blood Cells","H50513",,"1 unit","Blood product, which was collected from a donor in which donor suitability was not adequately determined, was distributed.",12/9/2006,"12/09/2006",9/25/2013,"09/25/2013"
"Biologics",43821,"Terminated","HemaCare Corporation","Van Nuys","CA","US","Voluntary: Firm Initiated","Letter","CA","B-2184-13","Class II","Red Blood Cells","FW04380",".","1 unit","Blood products, collected from a donor who was previously deferred, were distributed.. ",9/13/2006,"09/13/2006",9/18/2013,"09/18/2013"
"Biologics",43821,"Terminated","HemaCare Corporation","Van Nuys","CA","US","Voluntary: Firm Initiated","Letter","CA","B-2185-13","Class II","Fresh Frozen Plasma","FW04380",".","1 unit","Blood products, collected from a donor who was previously deferred, were distributed.. ",9/13/2006,"09/13/2006",9/18/2013,"09/18/2013"
"Biologics",43835,"Terminated","LifeServe Blood Center","Des Moines","IA","US","Voluntary: Firm Initiated","Letter","Iowa","B-0711-13","Class II","Red Blood Cells","LT37295",,"1 Unit","Blood product, positive for the JKb-antigen but labeled as JKb-antigen negative, was distributed.",12/13/2006,"12/13/2006",3/13/2013,"03/13/2013"
"Biologics",43847,"Terminated","American National Red Cross (The)","West Henrietta","NY","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","New York and South Carolina","B-1142-13","Class II","Red Blood Cells","25FG53377; 25FR30134; ",,"2","Blood products, collected from a deferred donor, were distributed.",12/12/2006,"12/12/2006",5/22/2013,"05/22/2013"
"Biologics",43847,"Terminated","American National Red Cross (The)","West Henrietta","NY","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","New York and South Carolina","B-1143-13","Class II","Platelets","25FR30134; 25KK27769",,"2","Blood products, collected from a deferred donor, were distributed.",12/12/2006,"12/12/2006",5/22/2013,"05/22/2013"
"Biologics",43849,"Terminated","American National Red Cross (The)","West Henrietta","NY","US","Voluntary: Firm Initiated","Letter","NY, OH, MI","B-0798-13","Class II","Cryoprecipitated AHF","31GE08119",,"1 unit","Blood products, collected from a donor who was previously deferred, were distributed.",12/15/2006,"12/15/2006",4/17/2013,"04/17/2013"
"Biologics",43849,"Terminated","American National Red Cross (The)","West Henrietta","NY","US","Voluntary: Firm Initiated","Letter","NY, OH, MI","B-0801-13","Class II","Fresh Frozen Plasma","31GE03055",,"1 unit","Blood products, collected from a donor who was previously deferred, were distributed.",12/15/2006,"12/15/2006",4/17/2013,"04/17/2013"
"Biologics",43849,"Terminated","American National Red Cross (The)","West Henrietta","NY","US","Voluntary: Firm Initiated","Letter","NY, OH, MI","B-0800-13","Class II","Platelets","31GE08119",,"1 unit","Blood products, collected from a donor who was previously deferred, were distributed.",12/15/2006,"12/15/2006",4/17/2013,"04/17/2013"
"Biologics",43849,"Terminated","American National Red Cross (The)","West Henrietta","NY","US","Voluntary: Firm Initiated","Letter","NY, OH, MI","B-0799-13","Class II","Red Blood Cells","31GE03055; 31GE08119",,"2 units ","Blood products, collected from a donor who was previously deferred, were distributed.",12/15/2006,"12/15/2006",4/17/2013,"04/17/2013"
"Biologics",43859,"Terminated","American National Red Cross (The)","Omaha","NE","US","Voluntary: Firm Initiated","FAX","MI.","B-0602-13","Class II","Platelets Pheresis Leukocytes Reduced","09GP18023(Part A); 09GP18023(Part B)",,"2 units","Blood products, which did not meet the acceptable product specifications, were distributed.",11/30/2006,"11/30/2006",2/20/2013,"02/20/2013"
"Biologics",43899,"Terminated","The Blood Alliance, Inc.","Jacksonville","FL","US","Voluntary: Firm Initiated","Letter","Florida","B-0920-13","Class II","Red Blood Cells Leukocytes Reduced","5828716",".","1 unit","Blood product, which was collected from a donor who traveled to malarial endemic area, was distributed.",11/28/2006,"11/28/2006",4/24/2013,"04/24/2013"
"Biologics",43942,"Terminated","Florida Georgia Blood Alliance, Inc.","Jacksonville","FL","US","Voluntary: Firm Initiated","Letter","FL and SC","B-1539-13","Class II","Red Blood Cells","1953428; 4823063",".","2 units","Blood products, which were collected from a donor who traveled to a malarial endemic area, were distributed.",12/9/2006,"12/09/2006",7/10/2013,"07/10/2013"
"Biologics",43942,"Terminated","Florida Georgia Blood Alliance, Inc.","Jacksonville","FL","US","Voluntary: Firm Initiated","Letter","FL and SC","B-1540-13","Class II","Platelets","4823063",".","1 unit","Blood products, which were collected from a donor who traveled to a malarial endemic area, were distributed.",12/9/2006,"12/09/2006",7/10/2013,"07/10/2013"
"Biologics",43945,"Terminated","Community Blood Center of the Ozarks","Springfield","MO","US","Voluntary: Firm Initiated","Letter","MO, Austria","B-0603-13","Class II","Red Blood Cells","6726065",,"1 unit","Blood products, collected from a donor taking the medication Accutane, were distributed.",1/10/2007,"01/10/2007",2/20/2013,"02/20/2013"
"Biologics",43953,"Terminated","Community Blood Centers of South Florida, Inc.","Lauderhill","FL","US","Voluntary: Firm Initiated","Telephone","Florida","B-1389-13","Class II","Platelets Pheresis Leukocytes Reduced","2238974(Part A); 2238974(Part B); 2238974(Part C)",".","3 units","Blood products, which were labeled as leukoreduced, but were not tested to verify the White Blood Cell count, were distributed.",12/21/2006,"12/21/2006",6/19/2013,"06/19/2013"
"Biologics",43959,"Terminated","American National Red Cross (The)","West Henrietta","NY","US","Voluntary: Firm Initiated","FAX","New York","B-2347-13","Class III","Red Blood Cells","01KH81493;01KH81496;01KH81499;01KK05209;01KK05214;01KX84353;01KX84355;01KX84356;01KX84358;01Q76121;01Q76123;01Q76124;01Q76128;01Q76129;01Y56415;01Y56417;01Y56419;01Y56421;01KH81504;01KH81503;01KH81501;01KH81500;01KH81498;01KH81497;01KK05212;01KK05208;01KK05204;01KK05203;01KH81502;01Y56420;01Q76127;01KX84354;01KX84352;01KF85597;01KF85596;01Y56423;01Q76131;01Q76130;01Q76126;01KX84357;01KX84351;01KX84348;01KX84347;01Y56422;01Q76125;01Q76132;01KK05206;01KK05207;01KH81495",,"49 units","Blood products, not prepared in accordance with specifications, were distributed.",11/21/2006,"11/21/2006",11/6/2013,"11/06/2013"
"Biologics",43967,"Terminated","Blood Bank Of San Bernardino and Riverside Counties","San Bernardino","CA","US","Voluntary: Firm Initiated","Telephone","California","B-2037-13","Class III","Platelets Pheresis Leukocytes Reduced","GS89507;GS89508;GS89768;GS89768;GS90434;GS90435;GS88058;GS90435;GS90436;GS90436;GS90439;GS90440;GS88056;GS88056;GS88058;GS90437;GS90443;GS90446;GS90449;GS89768;GS90445;GS90445;GS90446;GS90451",".","24 units","Blood products, for which storage condition was outside the acceptable range, were distributed.",12/5/2006,"12/05/2006",8/28/2013,"08/28/2013"
"Biologics",43967,"Terminated","Blood Bank Of San Bernardino and Riverside Counties","San Bernardino","CA","US","Voluntary: Firm Initiated","Telephone","California","B-2036-13","Class III","Platelets Pheresis Leukocytes Reduced Irradiated","GS89507;GS90434;GS90437;GS90439;GS90441;GS90445;GS88058;GS90444;GS90446",".","9 units","Blood products, for which storage condition was outside the acceptable range, were distributed.",12/5/2006,"12/05/2006",8/28/2013,"08/28/2013"
"Biologics",43981,"Terminated","Hoxworth Blood Center University of Cincinnati Medical Center","Cincinnati","OH","US","Voluntary: Firm Initiated","Letter","OH","B-2003-13","Class II","Fresh Frozen Plasma","2815693",".","1 unit","Blood products, with a low volume, were distributed.",10/25/2006,"10/25/2006",8/28/2013,"08/28/2013"
"Biologics",43981,"Terminated","Hoxworth Blood Center University of Cincinnati Medical Center","Cincinnati","OH","US","Voluntary: Firm Initiated","Letter","OH","B-2002-13","Class II","Red Blood Cells Leukocytes Reduced","2819133; 2815693; 1696707",".","3 units","Blood products, with a low volume, were distributed.",10/25/2006,"10/25/2006",8/28/2013,"08/28/2013"
"Biologics",44002,"Terminated","American National Red Cross (The)","Toledo","OH","US","Voluntary: Firm Initiated","Letter","Products were distributed to a hospital in Akron, OH","B-1935-13","Class III","Red Blood Cells Leukocytes Reduced","042FP20630",".","1 component","Blood product, with donor hematocrit determined using an analyzer for which the normal control was out of range, was distributed.",10/5/2006,"10/05/2006",8/14/2013,"08/14/2013"
"Biologics",44013,"Terminated","Lane Memorial Blood Bank","Eugene","OR","US","Voluntary: Firm Initiated","Letter","Switzerland, ID, Alaska, HI, CA, FL, TN, OR, NY","B-1269-13","Class II","Fresh Frozen Plasma","7433003, 7427598, 7126000, 7129884, 7129900, 7129911, 7227001, 7229972, 7230034, 7230618, 7231303, 7231892, 7232394, 7232746, 7427094, 7429022, 7429417, 7431031, 7431970, 7435205, 7125625, 7125928, 7126034, 7126056, 7126364, 7126375, 7126398, 7127086, 7127170, 7127274, 7127310, 7127370, 7127600, 7127773, 7127854, 7129022, 7129026, 7129034, 7129449, 7129588, 7129843, 7129886, 7130195, 7130253, 7131235, 7227171, 7227201, 7227507, 7228351, 7228392, 7228859, 7229272, 7229323, 7229349, 7229364, 7229488, 7229723, 7229799, 7230109, 7230650, 7231162, 7231300, 7231344, 7231415, 7232619, 7232986, 7233571, 7233686, 7233707, 7235321, 7235381, 7235414, 7427055, 7427113, 7427170, 7427293, 7427482, 7427600, 7427601, 7427612, 7427929, 7428062, 7428065, 7428075, 7428103, 7428229, 7428231, 7428232, 7428388, 7428410, 7428459, 7428846, 7428851, 7428902, 7428918, 7428956, 7428963, 7428969, 7428991, 7429206, 7429208, 7429288, 7429423, 7429657, 7429875, 7429900, 7429911, 7430051, 7430123, 7430955, 7430963, 7431033, 7431078, 7431478, 7431569, 7431785, 7432089, 7432142, 7432144, 7432242, 7432253, 7432344, 7432662, 7432692, 7432699, 7432719, 7432773, 7432778, 7432828, 7433050, 7433075, 7433112, 7433114, 7433118, 7433127, 7433144, 7433176, 7433495, 7433507, 7433508, 7433516, 7433596, 7433617, 7433647, 7433677, 7433945, 7434078, 7434098, 7434099, 7434137, 7434139, 7434155, 7434469, 7434761, 7435005, 7435210, 7435661, 7435997, 7436543, 7600127, 7600130, 7233549, 7235338, 7126505, 7130473, 7131976, 7229363, 7230671, 7428552.",".","169 units","Blood products, collected from a donor who emigrated from an area considered at risk for human immunodeficiency virus (HIV) Group O, were distributed.",12/6/2006,"12/06/2006",6/5/2013,"06/05/2013"
"Biologics",44013,"Terminated","Lane Memorial Blood Bank","Eugene","OR","US","Voluntary: Firm Initiated","Letter","Switzerland, ID, Alaska, HI, CA, FL, TN, OR, NY","B-1270-13","Class II","Red Blood Cells","7125234, 7125397, 7125784, 7227088, 7227333, 7427134, 7427141, 7427411, 7427566, 7427775, 7427808, 7427841, 7428040, 7428099, 7428112, 7125231, 7125263, 7125557, 7125692, 7125759, 7125928, 7126034, 7226962, 7227039, 7227305, 7227399, 7227534, 7427067, 7427113, 7427591, 7427598, 7427617, 7427624, 7427738, 7427755, 7427867, 7427889, 7427904, 7427945, 7428030, 7428056, 7428064, 7428139, 7428160, 7125556, 7227359, 7228335, 7427216, 7427554, 7427563, 7427784, 7427866, 7427888, 7427890, 7427891, 7427897, 7427907, 7428017, 7428058, 7125243, 7125274, 7125290, 7125447, 7125517, 7125632, 7125834, 7226952, 7226982, 7227001, 7227012, 7227024, 7227087, 7227156, 7227166, 7227171, 7227252, 7227413, 7227527, 7227631, 7227831, 7227832, 7227917, 7228007, 7427055, 7427073, 7427083, 7427099, 7427102, 7427142, 7427143, 7427151, 7427155, 7427173, 7427200, 7427215, 7427220, 7427231, 7427252, 7427253, 7427278, 7427283, 7427293, 7427306, 7427412, 7427419, 7427420, 7427425, 7427482, 7427502, 7427546, 7427548, 7427551, 7427569, 7427576, 7427589, 7427590, 7427592, 7427593, 7427600, 7427612, 7427721, 7427722, 7427740, 7427741, 7427760, 7427778, 7427780, 7427792, 7427794, 7427847, 7427871, 7427887, 7427898, 7427905, 7427947, 7427951, 7427959, 7427994, 7428001, 7428065, 7428075, 7428087, 7428102, 7428150, 7600026, 7427280, 7227235. ",".","147 units","Blood products, collected from a donor who emigrated from an area considered at risk for human immunodeficiency virus (HIV) Group O, were distributed.",12/6/2006,"12/06/2006",6/5/2013,"06/05/2013"
"Biologics",44013,"Terminated","Lane Memorial Blood Bank","Eugene","OR","US","Voluntary: Firm Initiated","Letter","Switzerland, ID, Alaska, HI, CA, FL, TN, OR, NY","B-1268-13","Class II","Red Blood Cells, Leukocytes Reduced","7126037, 7126851, 7231541, 7233722, 7427262, 7428103, 7428115, 7428185, 7428187, 7428237, 7428238, 7428253, 7428259, 7428600, 7428672, 7429322, 7429567, 7432600, 7126394, 7428520, 7429211, 7126153, 7430972, 7430291, 7433622, 7130041, 7230313, 7231344, 7231852, 7429968, 7431818, 7432498, 7433768, 7433777, 7434213, 7434544, 7434564, 7436396, 7436397, 7125583, 7125987, 7126505, 7126628, 7126785, 7127086, 7127154, 7127314, 7127414, 7127430, 7127442, 7127600, 7127854, 7128317, 7129588, 7130255, 7130711, 7131415, 7131976, 7227278, 7228058, 7228132, 7228479, 7228512, 7228520, 7228571, 7228682, 7229235, 7229305, 7229507, 7229775, 7229793, 7230034, 7230109, 7230326, 7230801, 7231028, 7231162, 7231714, 7232224, 7232363, 7232640, 7232746, 7232986, 7233600, 7233993, 7235656, 7427539, 7427541, 7427770, 7427776, 7427801, 7428067, 7428135, 7428155, 7428399, 7428410, 7428574, 7428619, 7428642, 7428665, 7428718, 7428841, 7428843, 7428845, 7428850, 7428871, 7428876, 7428907, 7428922, 7428944, 7428963, 7429038, 7429059, 7429091, 7429107, 7429544, 7430381, 7430435, 7430561, 7430747, 7430753, 7430757, 7430908, 7430920, 7430960, 7430963, 7431078, 7431132, 7431174, 7431216, 7431960, 7431970, 7432011, 7432018, 7432144, 7432314, 7432344, 7432376, 7432382, 7432604, 7432617, 7432965, 7433050, 7433144, 7433176, 7433302, 7433358, 7433372, 7433516, 7433548, 7433598, 7433798, 7433816, 7433948, 7434078, 7434137, 7434139, 7434157, 7434233, 7434249, 7434411, 7434428, 7434469, 7434599, 7434638, 7434759, 7435309, 7435312, 7435536, 7435749, 7436205, 7436363, 7436373, 7436393, 7436404, 7436775, 7436782, 7125729, 7126175, 7127324, 7127501, 7127773, 7129349, 7130170, 7130942, 7130984, 7131027, 7227031, 7227368, 7228048, 7228635, 7228656, 7228898, 7229328, 7229363, 7229364, 7229836, 7230618, 7231092, 7231415, 7231782, 7232332, 7232417, 7232510, 7232647, 7232794, 7233393, 7234472, 7234473, 7235040, 7235840, 7427385, 7427392, 7427522, 7427586, 7427880, 7428062, 7428069, 7428100, 7428213, 7428240, 7428251, 7428264, 7428268, 7428270, 7428376, 7428388, 74",".","909 units","Blood products, collected from a donor who emigrated from an area considered at risk for human immunodeficiency virus (HIV) Group O, were distributed.",12/6/2006,"12/06/2006",6/5/2013,"06/05/2013"
"Biologics",44013,"Terminated","Lane Memorial Blood Bank","Eugene","OR","US","Voluntary: Firm Initiated","Letter","Switzerland, ID, Alaska, HI, CA, FL, TN, OR, NY","B-1267-13","Class II","Cryoprecipitated AHF, Pooled","8000554, 8000567, 8000570, 8000572, 8000574, 8000575, 8000576, 8000581, 8000583, 8000589, 8000603, 8000611, 8000613, 8000624, 8000646, 8000648, 8000652, 8000658, 8000672, 8000678.",".","20 units","Blood products, collected from a donor who emigrated from an area considered at risk for human immunodeficiency virus (HIV) Group O, were distributed.",12/6/2006,"12/06/2006",6/5/2013,"06/05/2013"
"Biologics",44013,"Terminated","Lane Memorial Blood Bank","Eugene","OR","US","Voluntary: Firm Initiated","Letter","Switzerland, ID, Alaska, HI, CA, FL, TN, OR, NY","B-1271-13","Class II","Platelets Pheresis ","7230082, 7230082. ",".","2 units","Blood products, collected from a donor who emigrated from an area considered at risk for human immunodeficiency virus (HIV) Group O, were distributed.",12/6/2006,"12/06/2006",6/5/2013,"06/05/2013"
"Biologics",44013,"Terminated","Lane Memorial Blood Bank","Eugene","OR","US","Voluntary: Firm Initiated","Letter","Switzerland, ID, Alaska, HI, CA, FL, TN, OR, NY","B-1266-13","Class II","Platelets Pheresis Leukocytes Reduced","7128661, 7125441, 7125468, 7227594, 7229093, 7229269, 7229699, 7229772, 7231367, 7234488. ",".","10 units","Blood products, collected from a donor who emigrated from an area considered at risk for human immunodeficiency virus (HIV) Group O, were distributed.",12/6/2006,"12/06/2006",6/5/2013,"06/05/2013"
"Biologics",44031,"Terminated","American National Red Cross (The)","West Henrietta","NY","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","New York","B-0736-13","Class III","Red Blood Cells (Apheresis) Leukocytes Reduced","01FJ07492A; 01FJ07492B;01FJ07493A; 01FJ07493B; 01FJ07494A; 01FJ07494B",,"6","Blood products, which may have been transported under unacceptable temperatures after collection, were distributed.",12/22/2006,"12/22/2006",5/8/2013,"05/08/2013"
"Biologics",44064,"Terminated","Blood Bank of San Bernardino and Riverside Counties","San Bernardino","CA","US","Voluntary: Firm Initiated","Letter","CA","B-2192-13","Class II","Blood and Blood Products for Reprocessing","GP30924",".","1 unit","Blood products, collected from a donor who was at risk for variant Creutzfeldt-Jakob disease (vCJD), were distributed.",1/26/2007,"01/26/2007",10/2/2013,"10/02/2013"
"Biologics",44064,"Terminated","Blood Bank of San Bernardino and Riverside Counties","San Bernardino","CA","US","Voluntary: Firm Initiated","Letter","CA","B-2191-13","Class II","Red Blood Cells Leukocytes Reduced","GP30924",".","1 unit","Blood products, collected from a donor who was at risk for variant Creutzfeldt-Jakob disease (vCJD), were distributed.",1/26/2007,"01/26/2007",10/2/2013,"10/02/2013"
"Biologics",44079,"Terminated","Mississippi Valley Reg Bld Ctr","Davenport","IA","US","Voluntary: Firm Initiated","Telephone","IA, IL","B-0501-13","Class III","Red Blood Cells Leukocytes Reduced","GT94960; GT94963",,"2 units","Blood products, collected using equipment for which quality control was not performed, were distributed. ",1/10/2007,"01/10/2007",2/13/2013,"02/13/2013"
"Biologics",44083,"Terminated","American National Red Cross (The)","Boise","ID","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","California, Idaho, Oregon, Utah, and Washington.","B-1446-13","Class III","Platelets Pheresis Leukocytes Reduced","20LG14560, 21LG14560, 20LG14561, 20LG14561, 20LG14562, 20LG14564, 20LG14568, 20LR21315, 20LR21315, 20LR25072, 20LR25073, 20LR25073, 20LR25074, 20LR25076, 20LR25076, 20LR25079, 20LR25079, 20LR25086, 20LR25087, 20LR25088, 20P 34149, 20P 34175, 20R 21315, 20R 21322, ",,"24 Components","Platelets, possibly exposed to unacceptable temperatures, were distributed. ",10/23/2006,"10/23/2006",7/3/2013,"07/03/2013"
"Biologics",44083,"Terminated","American National Red Cross (The)","Boise","ID","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","California, Idaho, Oregon, Utah, and Washington.","B-1445-13","Class III","Platelets Pheresis Leukocytes Reduced Irradiated","20LG14558, 20LG14559, 20LG14559, 20LG14565, 20LG14566, 20LR25072, 20LR25075, 20LR25075, 20LR25077, 20LR25082, 20LR25082, 20LR25083, 20LR25083, 20LR25084, 20LR25084, 20LR25085, 20R 21322, ",,"17 Components","Platelets, possibly exposed to unacceptable temperatures, were distributed. ",10/23/2006,"10/23/2006",7/3/2013,"07/03/2013"
"Biologics",44128,"Terminated","American National Red Cross (The)","Boise","ID","US","Voluntary: Firm Initiated","FAX","UT, CA","B-0693-13","Class II","Red Blood Cells Leukocytes Reduced","020KK40568",,"1 unit","Blood products, collected from a donor for whom donor suitability were not adequately determined, was distributed.",12/27/2006,"12/27/2006",4/3/2013,"04/03/2013"
"Biologics",44128,"Terminated","American National Red Cross (The)","Boise","ID","US","Voluntary: Firm Initiated","FAX","UT, CA","B-1694-13","Class III","Blood and Blood Products for Reprocessing","020KK40568",,"1 unit","Blood products, collected from a donor for whom donor suitability were not adequately determined, was distributed.",12/27/2006,"12/27/2006",4/3/2013,"04/03/2013"
"Biologics",44134,"Terminated","University of Texas Medical Branch at Galveston (The)","Galveston","TX","US","Voluntary: Firm Initiated","FAX","TX","B-0437-13","Class II","Red Blood Cells (Apheresis)","4045540",".","1 unit","Blood product, which was labeled as leukoreduced, but was not tested to verify the White Blood Cell count, was distributed. .",12/20/2006,"12/20/2006",2/6/2013,"02/06/2013"
"Biologics",44156,"Terminated","American National Red Cross (the)","West Henrietta","NY","US","Voluntary: Firm Initiated","Telephone","Connecticut, New York","B-0613-13","Class II","Plasma Frozen Cryoprecipitated Reduced","01LN53192",,"1 unit","Blood products, which were collected from a donor in which donor suitability was not adequately determined, were distributed.",12/27/2006,"12/27/2006",2/20/2013,"02/20/2013"
"Biologics",44156,"Terminated","American National Red Cross (the)","West Henrietta","NY","US","Voluntary: Firm Initiated","Telephone","Connecticut, New York","B-0612-13","Class II","Red Blood Cells Leukocytes Reduced","01LN53192",,"1 unit","Blood products, which were collected from a donor in which donor suitability was not adequately determined, were distributed.",12/27/2006,"12/27/2006",2/20/2013,"02/20/2013"
"Biologics",44156,"Terminated","American National Red Cross (the)","West Henrietta","NY","US","Voluntary: Firm Initiated","Telephone","Connecticut, New York","B-0611-13","Class II","Cryoprecipitated AHF","01LN53192",,"1 unit","Blood products, which were collected from a donor in which donor suitability was not adequately determined, were distributed.",12/27/2006,"12/27/2006",2/20/2013,"02/20/2013"
"Biologics",44158,"Terminated","BioLife Plasma Services L.P.","Denton","TX","US","Voluntary: Firm Initiated","FAX","CA","B-0330-13","Class III","Source Plasma","06DTXC0279",".","1 unit","Blood product, collected from a donor for whom donor suitability was not adequately determined, was distributed.",1/16/2007,"01/16/2007",2/6/2013,"02/06/2013"
"Biologics",44203,"Terminated","American National Red Cross (The)","Columbus","OH","US","Voluntary: Firm Initiated","Letter","Products were distributed to two hospitals in Columbus, OH","B-1914-13","Class II","Fresh Frozen Plasma (Apheresis)","16KF51806",".","1 component","Blood Products, collected in an apheresis kit which was not used within the specified time period after priming, were distributed.",11/17/2006,"11/17/2006",9/18/2013,"09/18/2013"
"Biologics",44203,"Terminated","American National Red Cross (The)","Columbus","OH","US","Voluntary: Firm Initiated","Letter","Products were distributed to two hospitals in Columbus, OH","B-1913-13","Class II","Platelets Pheresis Leukocytes Reduced Irradiated","16KF51806",".","1 component","Blood Products, collected in an apheresis kit which was not used within the specified time period after priming, were distributed.",11/17/2006,"11/17/2006",9/18/2013,"09/18/2013"
"Biologics",44226,"Terminated","American National Red Cross (The)","Columbus","OH","US","Voluntary: Firm Initiated","Letter","OH","B-1911-13","Class II","Red Blood Cells Leukocytes Reduced","16GM57521",".","1 component","Blood products, collected from a donor whose suitability to donate was not adequately determined, were distributed. ",1/17/2007,"01/17/2007",8/14/2013,"08/14/2013"
"Biologics",44226,"Terminated","American National Red Cross (The)","Columbus","OH","US","Voluntary: Firm Initiated","Letter","OH","B-1912-13","Class III","Blood and Blood Products for Reprocessing","16GM57521",".","1 component","Blood products, collected from a donor whose suitability to donate was not adequately determined, were distributed. ",1/17/2007,"01/17/2007",8/14/2013,"08/14/2013"
"Biologics",44232,"Terminated","American National Red Cross (The)","Toledo","OH","US","Voluntary: Firm Initiated","Letter","Ohio.","B-1922-13","Class III","Platelets Leukocytes Reduced","42H50733",".","1 component","Blood products, collected from donors who answered a donor screening question inappropriately, were distributed.",12/8/2006,"12/08/2006",9/18/2013,"09/18/2013"
"Biologics",44232,"Terminated","American National Red Cross (The)","Toledo","OH","US","Voluntary: Firm Initiated","Letter","Ohio.","B-1921-13","Class III","Red Blood Cells Leukocytes Reduced","42H50733",".","1 component","Blood products, collected from donors who answered a donor screening question inappropriately, were distributed.",12/8/2006,"12/08/2006",9/18/2013,"09/18/2013"
"Biologics",44234,"Terminated","American National Red Cross (The)","Toledo","OH","US","Voluntary: Firm Initiated","Letter","OH","B-1910-13","Class II","Red Blood Cells (Apheresis) Leukocytes Reduced","50KW03215",".","2 components","Blood products, collected from a donor whose suitability to donate was not adequately determined, were distributed.",12/20/2006,"12/20/2006",8/14/2013,"08/14/2013"
"Biologics",44254,"Terminated","Csl Plasma Inc","Tempe","AZ","US","Voluntary: Firm Initiated","Letter","Illinois","B-1720-13","Class II","Source Plasma","4270046590",,"1 unit","Blood product, collected from a donor whose physical exam was incomplete, was distributed. ",2/2/2007,"02/02/2007",7/3/2013,"07/03/2013"
"Biologics",44292,"Terminated","Blood Bank of San Bernardino and Riverside Counties","San Bernardino","CA","US","Voluntary: Firm Initiated","Telephone","CA","B-2464-13","Class III","Red Blood Cells Leukocytes Reduced","GZ15170",,"1 unit","Blood product, manufactured without additive solution, was distributed.",1/26/2007,"01/26/2007",11/27/2013,"11/27/2013"
"Biologics",44314,"Terminated","American National Red Cross (The)","West Henrietta","NY","US","Voluntary: Firm Initiated","Letter","NY, IL, and PA","B-1722-13","Class II","Platelets","01KF87789; 01KF89027; 01KF91944; 01KF92867; 01KF93961; 01KF95240; 01KF84002; 01KF81650; 01KF79712",,"9 units","Blood products, in which donor incorrectly identified on deferral list and should have been previously deferred due to testing, were distributed.",12/12/2006,"12/12/2006",8/21/2013,"08/21/2013"
"Biologics",44314,"Terminated","American National Red Cross (The)","West Henrietta","NY","US","Voluntary: Firm Initiated","Letter","NY, IL, and PA","B-1726-13","Class II","Red Blood Cells Leukocytes Reduced Irradiated","01KF95240",,"1 units","Blood products, collected from a donor who was previously deferred, were distributed.",12/12/2006,"12/12/2006",8/21/2013,"08/21/2013"
"Biologics",44314,"Terminated","American National Red Cross (The)","West Henrietta","NY","US","Voluntary: Firm Initiated","Letter","NY, IL, and PA","B-1724-13","Class II","Red Blood Cells Leukocytes Reduced","01KF87789; 01KF89027; 01KF91944; 01KF92867; 01KF93961; 01KF86154; 01KF84002; 01KF81650; 01KF79712; 01KF75395; 01KX59077; 01KF86154; 01KF84002; 01KF81650; 01KF79712; 01KF75395; 01KX59077",,"11 units","Blood products, collected from a donor who was previously deferred, were distributed.",12/12/2006,"12/12/2006",8/21/2013,"08/21/2013"
"Biologics",44314,"Terminated","American National Red Cross (The)","West Henrietta","NY","US","Voluntary: Firm Initiated","Letter","NY, IL, and PA","B-1723-13","Class II","Fresh Frozen Plasma","01KF91944; 01KF92867; 01KX59077",,"3 units","Blood products, collected from a donor who was previously deferred, were distributed.",12/12/2006,"12/12/2006",8/21/2013,"08/21/2013"
"Biologics",44314,"Terminated","American National Red Cross (The)","West Henrietta","NY","US","Voluntary: Firm Initiated","Letter","NY, IL, and PA","B-1727-13","Class III","Blood and Blood Products for Reprocessing","01KF95240; 01KF86154; 01KF81650 ",,"3 units","Blood products, collected from a donor who was previously deferred, were distributed.",12/12/2006,"12/12/2006",8/21/2013,"08/21/2013"
"Biologics",44314,"Terminated","American National Red Cross (The)","West Henrietta","NY","US","Voluntary: Firm Initiated","Letter","NY, IL, and PA","B-1725-13","Class II","Plasma Frozen","01KF87789; 01KF89027; 01KF93961; 01KF84002; 01KF79712; 01KF75395",,"6 units","Blood products, collected from a donor who was previously deferred, were distributed.",12/12/2006,"12/12/2006",8/21/2013,"08/21/2013"
"Biologics",44316,"Terminated","American National Red Cross (The)","West Henrietta","NY","US","Voluntary: Firm Initiated","Letter","NY, MA, PA, , NC, and CA","B-1463-13","Class II","Fresh Frozen Plasma","31KX01728",,"1 component","Blood products, which tested negative for HIV, but were collected from a donor who previously tested positive for HIV, were distributed.",12/20/2006,"12/20/2006",6/26/2013,"06/26/2013"
"Biologics",44316,"Terminated","American National Red Cross (The)","West Henrietta","NY","US","Voluntary: Firm Initiated","Letter","NY, MA, PA, , NC, and CA","B-1465-13","Class III","Blood and Blood Products for Reprocessing","31KX00620;31KX01047;31KX01352;31KX02393;31KX02619;31KZ01164",,"6 components","Blood products, which tested negative for HIV, but were collected from a donor who previously tested positive for HIV, were distributed.",12/20/2006,"12/20/2006",6/26/2013,"06/26/2013"
"Biologics",44316,"Terminated","American National Red Cross (The)","West Henrietta","NY","US","Voluntary: Firm Initiated","Letter","NY, MA, PA, , NC, and CA","B-1464-13","Class II","Source Leukocytes","31KX01047",,"1 component ","Blood products, which tested negative for HIV, but were collected from a donor who previously tested positive for HIV, were distributed.",12/20/2006,"12/20/2006",6/26/2013,"06/26/2013"
"Biologics",44316,"Terminated","American National Red Cross (The)","West Henrietta","NY","US","Voluntary: Firm Initiated","Letter","NY, MA, PA, , NC, and CA","B-1461-13","Class II","Red Blood Cells","31KX00620;31KX01047;31KX01352;31KX01728;31KZ01164;31X25240",,"6 components ","Blood products, which tested negative for HIV, but were collected from a donor who previously tested positive for HIV, were distributed.",12/20/2006,"12/20/2006",6/26/2013,"06/26/2013"
"Biologics",44316,"Terminated","American National Red Cross (The)","West Henrietta","NY","US","Voluntary: Firm Initiated","Letter","NY, MA, PA, , NC, and CA","B-1462-13","Class II","Platelets","31KX01352;31X25240",,"2 component","Blood products, which tested negative for HIV, but were collected from a donor who previously tested positive for HIV, were distributed.",12/20/2006,"12/20/2006",6/26/2013,"06/26/2013"
"Biologics",44316,"Terminated","American National Red Cross (The)","West Henrietta","NY","US","Voluntary: Firm Initiated","Letter","NY, MA, PA, , NC, and CA","B-1460-13","Class II","Cryoprecipitated AHF","31KX00620;31KZ01164",,"2 components","Blood products, which tested negative for HIV, but were collected from a donor who previously tested positive for HIV, were distributed.",12/20/2006,"12/20/2006",6/26/2013,"06/26/2013"
"Biologics",44326,"Terminated","American National Red Cross","Boise","ID","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Utah.","B-1281-13","Class II","Red Blood Cells Leukocytes Reduced","020H06535",".","1 component","Blood product, collected from a donor in whom donor suitability was not adequately determined, was distributed.",12/14/2006,"12/14/2006",6/12/2013,"06/12/2013"
"Biologics",44351,"Terminated","The American National Red Cross South Carolina Region","Columbia","SC","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","South Carolina, California","B-0965-13","Class II","Red Blood Cells Leukocytes Reduced","36Q78865",".","1 unit","Blood products, collected from a donor who received a piercing within 12 months of donation, were distributed.",1/10/2007,"01/10/2007",5/15/2013,"05/15/2013"
"Biologics",44351,"Terminated","The American National Red Cross South Carolina Region","Columbia","SC","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","South Carolina, California","B-0966-13","Class II","Blood and Blood Products for Reprocessing","36Q78865",".","1 unit","Blood products, collected from a donor who received a piercing within 12 months of donation, were distributed.",1/10/2007,"01/10/2007",5/15/2013,"05/15/2013"
"Biologics",44355,"Terminated","Blood Bank of San Bernardino and Riverside Counties","San Bernardino","CA","US","Voluntary: Firm Initiated","Letter","California, Florida, Washington, D.C., Austria","B-1870-13","Class II","Red Blood Cells Leukocytes Reduced","GZ12807; GZ07733; GZ03746; GZ01265; GX91592; GX73202; GX66980",,"7 units","Blood products, collected from a donor who was at risk for variant Creutzfeldt-Jakob disease (vCJD), were distributed.",2/8/2007,"02/08/2007",8/7/2013,"08/07/2013"
"Biologics",44355,"Terminated","Blood Bank of San Bernardino and Riverside Counties","San Bernardino","CA","US","Voluntary: Firm Initiated","Letter","California, Florida, Washington, D.C., Austria","B-1873-13","Class III","Blood and Blood Products for Reprocessing","GZ03746; GX91592; GX66980",,"3 units","Blood products, collected from a donor who was at risk for variant Creutzfeldt-Jakob disease (vCJD), were distributed.",2/8/2007,"02/08/2007",8/7/2013,"08/07/2013"
"Biologics",44355,"Terminated","Blood Bank of San Bernardino and Riverside Counties","San Bernardino","CA","US","Voluntary: Firm Initiated","Letter","California, Florida, Washington, D.C., Austria","B-1868-13","Class II","Cryoprecipitated AHF","GX66980",,"1 unit","Blood products, collected from a donor who was at risk for variant Creutzfeldt-Jakob disease (vCJD), were distributed.",2/8/2007,"02/08/2007",8/7/2013,"08/07/2013"
"Biologics",44355,"Terminated","Blood Bank of San Bernardino and Riverside Counties","San Bernardino","CA","US","Voluntary: Firm Initiated","Letter","California, Florida, Washington, D.C., Austria","B-1872-13","Class II","Plasma Frozen Cryoprecipitated Reduced","GX73202",,"1unit","Blood products, collected from a donor who was at risk for variant Creutzfeldt-Jakob disease (vCJD), were distributed.",2/8/2007,"02/08/2007",8/7/2013,"08/07/2013"
"Biologics",44355,"Terminated","Blood Bank of San Bernardino and Riverside Counties","San Bernardino","CA","US","Voluntary: Firm Initiated","Letter","California, Florida, Washington, D.C., Austria","B-1869-13","Class II","Fresh Frozen Plasma","GZ12807; GZ07733; GZ01265",,"3 units","Blood products, collected from a donor who was at risk for variant Creutzfeldt-Jakob disease (vCJD), were distributed.",2/8/2007,"02/08/2007",8/7/2013,"08/07/2013"
"Biologics",44355,"Terminated","Blood Bank of San Bernardino and Riverside Counties","San Bernardino","CA","US","Voluntary: Firm Initiated","Letter","California, Florida, Washington, D.C., Austria","B-1871-13","Class II","Cryoprecipitated AHF, Pooled","G06089",,"1 unit","Blood products, collected from a donor who was at risk for variant Creutzfeldt-Jakob disease (vCJD), were distributed.",2/8/2007,"02/08/2007",8/7/2013,"08/07/2013"
"Biologics",44361,"Terminated","ONEBLOOD, Inc.","St Petersburg","FL","US","Voluntary: Firm Initiated","FAX","Florida","B-1969-13","Class III","Red Blood Cells","7971994",,"1","Blood product, collected from a deferred donor who was improperly re-entered, was distributed.",2/2/2007,"02/02/2007",7/31/2013,"07/31/2013"
"Biologics",44365,"Terminated","American National Red Cross (The)","Toledo","OH","US","Voluntary: Firm Initiated","Letter","OH","B-1909-13","Class III","Red Blood Cells Leukocytes Reduced","50LH79006",".","1 component","Blood products, which should have been quarantined pending an investigation, were distributed.",10/25/2006,"10/25/2006",10/2/2013,"10/02/2013"
"Biologics",44371,"Terminated","LifeServe Blood Center","Des Moines","IA","US","Voluntary: Firm Initiated","Letter","Iowa","B-0743-13","Class II","Red Blood Cells","LC83075",,"1 Unit","Blood product, positive for the E-antigen but labeled as E-antigen negative, was distributed.",2/14/2007,"02/14/2007",3/13/2013,"03/13/2013"
"Biologics",44379,"Terminated","Blood Bank of San Bernardino and Riverside Counties","San Bernardino","CA","US","Voluntary: Firm Initiated","Letter","California","B-2409-13","Class III","Red Blood Cells Leukocytes Reduced","GQ58593, GP16828, GW67707, GW67697, GP16214, GP16225, GP16217, GP16216, GZ02392, GZ02376, GZ02394, GZ02427, GZ02426, GQ57036, GQ57037, GQ57034, GQ57040, GZ02413, GQ57047, GQ57044, GP12805, GP16152, GP16144, GP15223, GZ02059, GZ02064, GP14150, GP14774, GP14149, GP06096, GP16294, GP16254, GP16252, GP16285, GP16251, GP16256, GP16289, GP06105, GP06101, GP06098",,"40 units","Blood products, which may have reached an unacceptable temperature during shipment, were distributed.",2/5/2007,"02/05/2007",11/6/2013,"11/06/2013"
"Biologics",44379,"Terminated","Blood Bank of San Bernardino and Riverside Counties","San Bernardino","CA","US","Voluntary: Firm Initiated","Letter","California","B-2407-13","Class III","Red Blood Cells","GS73316, GS73318, GS73305",,"3 units","Blood products, which may have reached an unacceptable temperature during shipment, were distributed.",2/5/2007,"02/05/2007",11/6/2013,"11/06/2013"
"Biologics",44379,"Terminated","Blood Bank of San Bernardino and Riverside Counties","San Bernardino","CA","US","Voluntary: Firm Initiated","Letter","California","B-2408-13","Class III","Liquid Plasma","GS73318",," 1 unit","Blood products, which may have reached an unacceptable temperature during shipment, were distributed.",2/5/2007,"02/05/2007",11/6/2013,"11/06/2013"
"Biologics",44379,"Terminated","Blood Bank of San Bernardino and Riverside Counties","San Bernardino","CA","US","Voluntary: Firm Initiated","Letter","California","B-2409-13","Class III","Red Blood Cells Leukocytes Reduced","GQ58593, GP16828, GW67707, GW67697, GP16214, GP16225, GP16217, GP16216, GZ02392, GZ02376, GZ02394, GZ02427, GZ02426, GQ57036, GQ57037, GQ57034, GQ57040, GZ02413, GQ57047, GQ57044, GP12805, GP16152, GP16144, GP15223, GZ02059, GZ02064, GP14150, GP14774, GP14149, GP06096, GP16294, GP16254, GP16252, GP16285, GP16251, GP16256, GP16289, GP06105, GP06101, GP06098",,"40 units","Blood products, which may have reached an unacceptable temperature during shipment, were distributed.",2/5/2007,"02/05/2007",11/6/2013,"11/06/2013"
"Biologics",44379,"Terminated","Blood Bank of San Bernardino and Riverside Counties","San Bernardino","CA","US","Voluntary: Firm Initiated","Letter","California","B-2407-13","Class III","Red Blood Cells","GS73316, GS73318, GS73305",,"3 units","Blood products, which may have reached an unacceptable temperature during shipment, were distributed.",2/5/2007,"02/05/2007",11/6/2013,"11/06/2013"
"Biologics",44407,"Terminated","Tri-counties Blood Bank","San Luis Obispo","CA","US","Voluntary: Firm Initiated","Telephone","California","B-1874-13","Class II","Red Blood Cells (Apheresis) Leukocytes Reduced","FZ83288; FZ83288",,"2 units","Blood products, released from quarantine prior to post leukoreduction, were distributed. ",1/24/2007,"01/24/2007",8/7/2013,"08/07/2013"
"Biologics",44409,"Terminated","Tri-counties Blood Bank","San Luis Obispo","CA","US","Voluntary: Firm Initiated","Letter","CA","B-2193-13","Class II","Red Blood Cells (Apheresis) Leukocytes Reduced","LT29798-part 1;LT29798-part 2",,"2 units","Blood products, collected using manufacturer collection kit greater than 24 hours, were distributed.",1/26/2007,"01/26/2007",8/21/2013,"08/21/2013"
"Biologics",44443,"Terminated","Hoxworth Blood Center University of Cincinnati Medical Center","Cincinnati","OH","US","Voluntary: Firm Initiated","Letter","OH","B-0099-13","Class II","Red Blood Cells Leukocytes Reduced","2833695",".","1 unit","Blood product, collected from a donor who was taking the drug Prednisone, were distributed.",1/10/2007,"01/10/2007",3/27/2013,"03/27/2013"
"Biologics",44449,"Terminated","American National Red Cross (The)","Columbus","OH","US","Voluntary: Firm Initiated","Letter","OH and PA","B-0239-13","Class II","Red Blood Cells Leukocytes Reduced","16LK41465",".","1 unit","Blood products, which were collected from a donor in which donor suitability was not adequately determined, were distributed.",1/29/2007,"01/29/2007",1/2/2013,"01/02/2013"
"Biologics",44449,"Terminated","American National Red Cross (The)","Columbus","OH","US","Voluntary: Firm Initiated","Letter","OH and PA","B-0241-13","Class II","Fresh Frozen Plasma","16LK41465",".","1 unit","Blood products, which were collected from a donor in which donor suitability was not adequately determined, were distributed.",1/29/2007,"01/29/2007",1/2/2013,"01/02/2013"
"Biologics",44449,"Terminated","American National Red Cross (The)","Columbus","OH","US","Voluntary: Firm Initiated","Letter","OH and PA","B-0240-13","Class II","Platelets Leukocytes Reduced","16LK41465",".","1 unit","Blood products, which were collected from a donor in which donor suitability was not adequately determined, were distributed.",1/29/2007,"01/29/2007",1/2/2013,"01/02/2013"
"Biologics",44463,"Terminated","American Red Cross Blood Services","Wichita","KS","US","Voluntary: Firm Initiated","Letter","KS and CA","B-0438-13","Class II","Red Blood Cells Leukocytes Reduced","02LC78216",".","1 unit","Blood products, which were collected from a donor in which donor suitability was not adequately determined, were distributed.",1/4/2007,"01/04/2007",2/6/2013,"02/06/2013"
"Biologics",44463,"Terminated","American Red Cross Blood Services","Wichita","KS","US","Voluntary: Firm Initiated","Letter","KS and CA","B-0439-13","Class III","Blood and Blood Products for Reprocessing","02LC78216",".","1 unit","Blood products, which were collected from a donor in which donor suitability was not adequately determined, were distributed.",1/4/2007,"01/04/2007",2/6/2013,"02/06/2013"
"Biologics",44496,"Terminated","American National Red Cross (The)","West Henrietta","NY","US","Voluntary: Firm Initiated","Telephone","NY, MD, and PA","B-0738-13","Class II","Red Blood Cells Leukocytes Reduced","01Q99451; 01Q99454; 01Q99477; 01Q99489; 01Q99497; 01Q99519; 01Q99522; 01Q99528; 01Q99531; 01Q99548; 01Q99552",,"11","Blood products, possibly contaminated with air during collection, were distributed. ",1/29/2007,"01/29/2007",3/13/2013,"03/13/2013"
"Biologics",44496,"Terminated","American National Red Cross (The)","West Henrietta","NY","US","Voluntary: Firm Initiated","Telephone","NY, MD, and PA","B-0739-13","Class II","Plasma Frozen","01Q99451;01Q99454;01Q99497",,"3","Blood products, possibly contaminated with air during collection, were distributed. ",1/29/2007,"01/29/2007",3/13/2013,"03/13/2013"
"Biologics",44496,"Terminated","American National Red Cross (The)","West Henrietta","NY","US","Voluntary: Firm Initiated","Telephone","NY, MD, and PA","B-0737-13","Class II","Platelets","01Q99477;01Q99514",,"2","Blood products, possibly contaminated with air during collection, were distributed. ",1/29/2007,"01/29/2007",3/13/2013,"03/13/2013"
"Biologics",44496,"Terminated","American National Red Cross (The)","West Henrietta","NY","US","Voluntary: Firm Initiated","Telephone","NY, MD, and PA","B-0740-13","Class II","Red Blood Cells Leukocytes Reduced Irradiated","01Q99487;01Q99492",,"2 ","Blood products, possibly contaminated with air during collection, were distributed. ",1/29/2007,"01/29/2007",3/13/2013,"03/13/2013"
"Biologics",44528,"Terminated","Department of the Navy","San Diego","CA","US","Voluntary: Firm Initiated","Letter","New Jersey","B-2280-13","Class III","Red Blood Cells Leukocytes Reduced","W021607000599",".","1 unit","Blood product, which did not meet the minimum requirement for Red Blood Cell recovery, was distributed.",2/2/2007,"02/02/2007",9/11/2013,"09/11/2013"
"Biologics",44539,"Terminated","HemaCare Corporation","Sherman Oaks","CA","US","Voluntary: Firm Initiated","Letter","California","B-1788-13","Class II","Platelets Pheresis Leukocytes Reduced","0726836; 0726836; 0726836",".","3 units","Blood products, which were collected from a donor who traveled to a malarial endemic area, were distributed. ",4/19/2007,"04/19/2007",7/17/2013,"07/17/2013"
"Biologics",44541,"Terminated","Hoxworth Blood Center University of Cincinnati Medical Center","Cincinnati","OH","US","Voluntary: Firm Initiated","Letter","OH","B-1526-13","Class II","Red Blood Cells Leukocytes Reduced","1623622",".","1 unit","Blood products, collected from a donor who traveled to a malarial endemic area, were distributed.",2/9/2007,"02/09/2007",7/10/2013,"07/10/2013"
"Biologics",44553,"Terminated","American Red Cross Blood Services","Saint Louis","MO","US","Voluntary: Firm Initiated","Telephone","Missouri","B-0604-13","Class II","Platelets Pheresis Leukocytes Reduced","011LS44292; 011LS44292; 011LS44292",,"3 Units","Blood products, in which quality control and distribution of products did not meet specifications, were distributed.",1/30/2007,"01/30/2007",2/20/2013,"02/20/2013"
"Biologics",44584,"Terminated","Interstate Blood Bank Inc Mo","Saint Louis","MO","US","Voluntary: Firm Initiated","FAX","Austria","B-1501-13","Class III","Source Plasma","LZ038995",,"1 Unit","Blood product, collected from a donor, whose suitability to donate was not adequately determined, was distributed.",2/9/2007,"02/09/2007",6/26/2013,"06/26/2013"
"Biologics",44607,"Terminated","The Blood Alliance, Inc.","Jacksonville","FL","US","Voluntary: Firm Initiated","FAX","Florida","B-1098-13","Class II","Fresh Frozen Plasma","4503686",,"1","Blood products, collected from a donor who was previously deferred for being at increased risk for vCJD, were distributed.",2/15/2007,"02/15/2007",5/22/2013,"05/22/2013"
"Biologics",44611,"Terminated","LifeServe Blood Center","Des Moines","IA","US","Voluntary: Firm Initiated","Letter","Iowa","B-0767-13","Class II","Red Blood Cells Leukocytes Reduced","LX62656",,"1 Unit","Blood product, collected from a donor who was considered at risk for human immunodeficiency virus (HIV) Group O, was distributed.",3/22/2007,"03/22/2007",5/8/2013,"05/08/2013"
"Biologics",44633,"Terminated","American National Red Cross (The)","Cleveland","OH","US","Voluntary: Firm Initiated","Telephone","Ohio","B-1299-13","Class II","Red Blood Cells (Apheresis) Leukocytes Reduced","42C18441; 42E48391; 42E48501; 42GX00897; 42N21930; 42Y48405; 42FN17577",".","7 components","Blood products, which were not screened for antibodies according to the reagent manufacturer's instructions, were distributed.",2/1/2007,"02/01/2007",6/5/2013,"06/05/2013"
"Biologics",44633,"Terminated","American National Red Cross (The)","Cleveland","OH","US","Voluntary: Firm Initiated","Telephone","Ohio","B-1298-13","Class II","Red Blood Cells","42FZ04668; 42FQ07085; 42G40637; 42Q78142; 42K57455; 42X70520; 42GC01832; 42FY42018; 42S96094; 42G43536; 42FE80206; 42GC03025; 42FP94339; 42FC12027; 42H38306; 42G45141; 42R70525; 42K63770; 42GF00087; 42GC04186; 42X79525; 42FX25436; 42F57319; 42FE85263; 42H42171; 42GC07199; 42K69861; 42GQ00947; 42GE12459;42R75067; 42FR08846; 42K72538; 42FF87015; 42GW00822; 42H41922; 42H42001; 42FT47934; 42G50965; 42FX32315; 42FY54715; 42FH29950; 42FH29952; 42FE89385; 42FG08750; 42FZ04668; 42FX32821; 42W37413; 42FE89690; 42FK67898; 42FF87745; 42FQ18227; 42FE89800; 42R76089; 42FX33179; 42FF87875; 42FR10445; 42FC15239; 42FZ05440; 42L18360; 42H42959; 42GW01149; 42FW25652; 42GW01166; 42G52689; 42R77333; 42W39053; 42FP04088; 42FE92188; 42GQ02161; 42F59943; 42FP04467; 42FF89640; 42FQ20201; 42FX37359; 42FY58678; 42FG12022; 42J56537; 42S04645; 42FX38323; 42FG12246; 42X00136; 42F60609; 42W40533; 42FP05906; 42FC16758; 42GE17473; 42W40923; 42R80473; 42FR17226; 42L24243; 42FG14862; 42H45314; 42S08856; 42FC18434; 42R81577; 42GS06844; 42FK70290; 42GK01123; 42L25375; 42FP09719; 42L26574; 42J61392; 42GW02619; 42GT05538; 42GS08851; 42FX45740; 42T41101; 42FX47488; 42FK71589; 42FG19047; 42GW03072; 42GS11320; 42FC21422; 42GW03167; 42FK72004; 42T43436; 42FQ29372; 42M21467; 42L31825; 42R87247; 42FR26882; 42GQ01660; 42GW03782; 42GW03913; 42FF02862; 42GK01702 ",".","126 components","Blood products, which were not screened for antibodies according to the reagent manufacturer's instructions, were distributed.",2/1/2007,"02/01/2007",6/5/2013,"06/05/2013"
"Biologics",44633,"Terminated","American National Red Cross (The)","Cleveland","OH","US","Voluntary: Firm Initiated","Telephone","Ohio","B-1297-13","Class II","Platelets Pheresis Leukocytes Reduced","42KP12009; 42KW21131; 42KW23881; 42KW32826; 042KW33193",".","4 components","Blood products, which were not screened for antibodies according to the reagent manufacturer's instructions, were distributed.",2/1/2007,"02/01/2007",6/5/2013,"06/05/2013"
"Biologics",44633,"Terminated","American National Red Cross (The)","Cleveland","OH","US","Voluntary: Firm Initiated","Telephone","Ohio","B-1296-13","Class II","Red Blood Cells Leukocytes Reduced","42FG97856; 42FX18928; 42FS77056; 42FW04560; 42FS77179; 42T14091; 42FW07587; 42FE77508; 42X69153; 42FT30987; 42FT32094; 42FT33242; 42Q80247; 42FX23314; 42FW14032; 42Y40592; 42K62728; 42FW15079; 42FP95695; 42T21726; 42FY46506; 42GC04041; 42FP95993; 42FW16055; 42FW16474; 42FJ17909; 42FY47360; 42E44031; 42GC04913; 42K65715; 42GC05249; 42K67824; 42GE10615; 42J50877; 42GE13124; 42K72330; 42FE88710; 42FX31697; 42FY54263; 42L17022; 42FE89129; 42FR09116; 42L17139; 42FY54595; 42FP01778; 42FC14745; 42FR09262; 42S01248; 42FP01855; 42FS86720; 42FT48521; 42T29128; 42GC09331; 42T29166; 42FE89487; 42FY54962; 42FJ25411; 42R75970; 42FJ25415; 42FJ25426; 42FP02096; 42FR09541; 42S01299; 42FP02164; 42FS87036; 42FE89738; 42X93965; 42R76080; 42K73873; 42FY55530; 42FW24320; 42FT49145; 42FH30943; 42G51800; 42H42656; 42L18182; 42X95754; 42L18885; 42FW25808; 42J54932; 42T31952; 42GS00091; 42FY58222; 42X97267; 42FX37195; 42T33419; 42FT51218; 42FR13746; 42J56320; 42X99784; 42J56672; 42GS02007; 42FX38429; 42K77697; 42FJ29389; 42GS02147; 42FT52111; 42GS02320; 42T34299; 42R79190; 42GC12641; 42FH35085; 42GS02509; 42J57025; 42T34535; 42FR14728; 42FX39460; 42FH35912; 42FR16537; 42K79507; 42FP07542; 42GS05379; 42FP08044; 42FG15013; 42FH38035; 42H45608; 42S09475; 42FR19529; 42T38927; 42J60615; 42R82601; 42FH38847; 42FX44325; 42FR20428; 42G57322; 42GE20896; 42FC20185; 42J62490; 42G57855; 42FY65616; 42GT06076; 42X11341; 42S13088; 42FR23408; 42X12294; 42G58827; 42J65036; 42J65656; 42GC19207; 42GC19403; 42J66118; 42FY68678; 42R87050; 42S16700; 42GE23950; 42S15779; 42FQ30098; 42S15858; 42W46282; 42J67374; 42FR27493; 42GE24867; 42J67510; 42FX51450; 42GT09019; 42FW28723; 42FW28741; 42FG21636; 42FX51795; 42GS14057; 42FP17550; 42FK72737; 42S17380; 42K86097; 42L33714; 42GS14524; 42FY70348; 42W46697; 42W46920; 42FR28885; 42FF00777; 42FY70871; 42FS94875; 42K88149; 42FT66986; 42GC22493; 42FK73459; 42GS16278; 42FH46147; 42FS95385; 42FJ41705; 42GT11407; 42T47055; 42FG24377; 42FP21685; 42GE28365; 42GS18470; 42K90300; 42R91583; 42G63752; 42FH48245; 42FY73968; 42GC",".","199 components","Blood products, which were not screened for antibodies according to the reagent manufacturer's instructions, were distributed.",2/1/2007,"02/01/2007",6/5/2013,"06/05/2013"
"Biologics",44633,"Terminated","American National Red Cross (The)","Cleveland","OH","US","Voluntary: Firm Initiated","Telephone","Ohio","B-1300-13","Class II","Red Blood Cells Leukocytes Removed Washed","42FG09596",".","1 component","Blood products, which were not screened for antibodies according to the reagent manufacturer's instructions, were distributed.",2/1/2007,"02/01/2007",6/5/2013,"06/05/2013"
"Biologics",44633,"Terminated","American National Red Cross (The)","Cleveland","OH","US","Voluntary: Firm Initiated","Telephone","Ohio","B-1301-13","Class II","Red Blood Cells Deglycerolized","42GQ00737",".","1 component","Blood products, which were not screened for antibodies according to the reagent manufacturer's instructions, were distributed.",2/1/2007,"02/01/2007",6/5/2013,"06/05/2013"
"Biologics",44641,"Terminated","Community Blood Bank, Inc.","Rancho Mirage","CA","US","Voluntary: Firm Initiated","Letter","FL, CA.","B-2335-13","Class II","Red Blood Cells Leukocytes Reduced","0616000",,"1 unit","Blood products, collected from a donor who traveled to an area considered endemic for malaria, were distributed.",3/9/2007,"03/09/2007",9/25/2013,"09/25/2013"
"Biologics",44645,"Terminated","LifeServe Blood Center","Des Moines","IA","US","Voluntary: Firm Initiated","Letter","Iowa; Switzerland","B-0896-13","Class III","Blood and Blood Products for Reprocessing","GM10559",".","1 Unit","Blood products, collected from a donor who had previously tested reactive for hepatitis, were distributed. ",3/16/2007,"03/16/2007",4/10/2013,"04/10/2013"
"Biologics",44645,"Terminated","LifeServe Blood Center","Des Moines","IA","US","Voluntary: Firm Initiated","Letter","Iowa; Switzerland","B-0895-13","Class III","Red Blood Cells Leukocytes Reduced","GM10559",".","1 Unit","Blood products, collected from a donor who had previously tested reactive for hepatitis, were distributed. ",3/16/2007,"03/16/2007",4/10/2013,"04/10/2013"
"Biologics",44651,"Terminated","Northwest Florida Blood Center, Inc.","Pensacola","FL","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Florida, Alabama.","B-1319-13","Class II","Platelets Pheresis Leukocytes Reduced","4737455A; 4737455B; 4737432A; 4737432B; 4737442A; 4737442B; 4737442C.",".","7 units","Blood products, which did not meet the acceptable product specifications, were distributed.",2/5/2007,"02/05/2007",6/5/2013,"06/05/2013"
"Biologics",44674,"Terminated","Blood Systems, Inc.","Scottsdale","AZ","US","Voluntary: Firm Initiated","Letter","Arizona","B-2356-13","Class III","Red Blood Cells Leukocytes Reduced Irradiated","103674108;103671378",".","2 units","Blood products, for which storage conditions and shipment information were undocumented, were distributed.",3/26/2007,"03/26/2007",9/18/2013,"09/18/2013"
"Biologics",44981,"Terminated","Northwest Florida Blood Center, Inc.","Pensacola","FL","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Florida.","B-1254-13","Class III","Red Blood Cells (Apheresis) Leukocytes Reduced"," Unit numbers 5213976A; 5213976B.",".","2 units","Blood products, which did not meet the acceptable product specifications, were distributed.",6/28/2007,"06/28/2007",6/5/2013,"06/05/2013"
"Biologics",44983,"Terminated","Northwest Florida Blood Center, Inc.","Pensacola","FL","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","AL","B-1538-13","Class II","Platelets Pheresis Leukocytes Reduced"," 4738509",".","1 unit","Blood products, which did not meet the acceptable product specifications, were distributed.",5/3/2007,"05/03/2007",7/10/2013,"07/10/2013"
"Biologics",44985,"Terminated","Florida Georgia Blood Alliance, Inc.","Jacksonville","FL","US","Voluntary: Firm Initiated","FAX","Florida","B-1257-13","Class II","Fresh Frozen Plasma","4825254",".","1 unit","Blood products, collected from a donor whose close contact with partner who emigrated from an area at risk for HIV-Group O, were distributed.",7/16/2007,"07/16/2007",6/5/2013,"06/05/2013"
"Biologics",44985,"Terminated","Florida Georgia Blood Alliance, Inc.","Jacksonville","FL","US","Voluntary: Firm Initiated","FAX","Florida","B-1256-13","Class II","Platelets","4825254",".","1 unit","Blood products, collected from a donor whose close contact with partner who emigrated from an area at risk for HIV-Group O, were distributed.",7/16/2007,"07/16/2007",6/5/2013,"06/05/2013"
"Biologics",44985,"Terminated","Florida Georgia Blood Alliance, Inc.","Jacksonville","FL","US","Voluntary: Firm Initiated","FAX","Florida","B-1255-13","Class II","Red Blood Cells","4825254",".","1 unit","Blood products, collected from a donor whose close contact with partner who emigrated from an area at risk for HIV-Group O, were distributed.",7/16/2007,"07/16/2007",6/5/2013,"06/05/2013"
"Biologics",44986,"Terminated","Florida Georgia Blood Alliance, Inc.","Jacksonville","FL","US","Voluntary: Firm Initiated","Telephone","FL","B-1662-13","Class III","Red Blood Cells Leukocytes Reduced","8604438; 8604441; 7807659; 7808666.",".","4 units","Blood products, for which there was no documentation for the time period out of controlled storage, were distributed.",7/26/2007,"07/26/2007",7/10/2013,"07/10/2013"
"Biologics",45024,"Terminated","Community Blood Centers of South Florida, Inc.","Lauderhill","FL","US","Voluntary: Firm Initiated","Telephone","Florida","B-1371-13","Class II","Platelets","2316124",,"1 unit","Blood products, collected from a donor who was previously deferred, due to testing Anti-HTLV reactive, were distributed.",7/19/2007,"07/19/2007",7/3/2013,"07/03/2013"
"Biologics",45024,"Terminated","Community Blood Centers of South Florida, Inc.","Lauderhill","FL","US","Voluntary: Firm Initiated","Telephone","Florida","B-1370-13","Class II","Red Blood Cells","2316124",,"1 unit","Blood products, collected from a donor who was previously deferred, due to testing Anti-HTLV reactive, were distributed..",7/19/2007,"07/19/2007",7/3/2013,"07/03/2013"
"Biologics",45071,"Terminated","ZLB Bioplasma, Inc.","Tulsa","OK","US","Voluntary: Firm Initiated","Other","IL, Switzerland","B-1349-13","Class II","Source Plasma","4170096945, 4170096061, 4170085861, 4170085417",".","4 units","Blood products, collected from a donor who did not have a complete physical examination, were distributed.",11/30/2009,"11/30/2009",5/1/2013,"05/01/2013"
"Biologics",45103,"Terminated","LifeServe Blood Center","Des Moines","IA","US","Voluntary: Firm Initiated","Telephone","Iowa; Pennsylvia","B-0853-13","Class II","Cryoprecipitated AHF","LX68180",".","1 Unit","Blood products, collected in a manner that may have compromised the sterility of the units, were distributed. ",8/16/2007,"08/16/2007",4/10/2013,"04/10/2013"
"Biologics",45103,"Terminated","LifeServe Blood Center","Des Moines","IA","US","Voluntary: Firm Initiated","Telephone","Iowa; Pennsylvia","B-0854-13","Class II","Red Blood Cells Leukocytes Reduced","LX68180",".","1 Unit","Blood products, collected in a manner that may have compromised the sterility of the units, were distributed. ",8/16/2007,"08/16/2007",4/10/2013,"04/10/2013"
"Biologics",45105,"Terminated","LifeServe Blood Center","Des Moines","IA","US","Voluntary: Firm Initiated","Letter","Iowa","B-0712-13","Class II","Platelets Pheresis Leukocytes Reduced","P40172 Part A ; P40172 Part B",,"2 Units","Blood products, for which the required quality control testing was not performed, were distributed.",8/22/2007,"08/22/2007",3/13/2013,"03/13/2013"
"Biologics",45117,"Terminated","American National Red Cross (The)","Saint Louis","MO","US","Voluntary: Firm Initiated","Telephone","MO","B-0251-13","Class II","Platelets Pheresis Leukocytes Reduced","011LT11137, 011LT11139 (2 units), 011LT11140, 011LT11141 (2 units), 011LT11142, 011LT11143 (2 units), 011LT11145, 011LT11146 (2 units), 011LT11148",".","13 units","Blood products, which were labeled as leukoreduced, but were not tested to verify white blood cell count, were distributed.",8/7/2007,"08/07/2007",2/6/2013,"02/06/2013"
"Biologics",45119,"Terminated","American National Red Cross (The)","Omaha","NE","US","Voluntary: Firm Initiated","Letter","PA, CO and CA","B-0177-13","Class II","Red Blood Cells Leukocytes Reduced","009FE12874; 09FQ21836",".","2 units","Blood products, collected from a donor whose suitability to donate was not adequately determined, were distributed.",7/13/2006,"07/13/2006",1/23/2013,"01/23/2013"
"Biologics",45119,"Terminated","American National Red Cross (The)","Omaha","NE","US","Voluntary: Firm Initiated","Letter","PA, CO and CA","B-0178-13","Class II","Platelets Pheresis Leukocytes Reduced","009GZ05786; 009GZ06597",".","2 units","Blood products, collected from a donor whose suitability to donate was not adequately determined, were distributed.",7/13/2006,"07/13/2006",1/23/2013,"01/23/2013"
"Biologics",45119,"Terminated","American National Red Cross (The)","Omaha","NE","US","Voluntary: Firm Initiated","Letter","PA, CO and CA","B-0179-13","Class III","Blood and Blood Products for Reprocessing","009FE12874; 09FQ21836",".","2 units","Blood products, collected from a donor whose suitability to donate was not adequately determined, were distributed.",7/13/2006,"07/13/2006",1/23/2013,"01/23/2013"
"Biologics",45120,"Terminated","American National Red Cross (The)","Omaha","NE","US","Voluntary: Firm Initiated","FAX","NE, PA, NJ","B-0200-13","Class II","Red Blood Cells Leukocytes Reduced","09GR11089; 09GR11095",,"2 units","Blood products, possibly contaminated with air, were distributed.",7/31/2007,"07/31/2007",3/20/2013,"03/20/2013"
"Biologics",45167,"Terminated","American National Red Cross (The)","Pomona","CA","US","Voluntary: Firm Initiated","Telephone","California","B-1800-13","Class III","Cryoprecipitated AHF","084FT06904, 084FT06961, 084FT07108, 084FT07114, 084FT07188, 021LC88992, 084FT07115, 084FT07117, 084FT07155, 084FT07157, 084FT06946, 084FT07211, 021LK33581, 021LC88495, 084FT07300, 084FT07101, 084Q 49296, 084FT07112, 084K 90768, 084K 91006, 084Q 49188, 021LC89396, 021LG50163, 021LH48240,021KS63809, 021KS63820, 021LJ44014, 021LJ44023, 021LK33463, 021LK33471, 084K 91594, 021KS63816, 084FT07855, 084FT07858, 084FT07860, 084FT07895, 084FT02469, 084K 91668, 084FT07872, 084Q 50129, 084W 89449, ",".","41","Blood products, lacking assurance of having been maintained at an acceptable temperature during shipping, were distributed. ",7/4/2007,"07/04/2007",7/24/2013,"07/24/2013"
"Biologics",45171,"Terminated","American National Red Cross (The)","Tucson","AZ","US","Voluntary: Firm Initiated","Letter","Arizona, California","B-1813-13","Class II","Red Blood Cells Leukocytes Reduced","007FC25436",,"1","Blood products, collected from a donor in whom donor suitability was not adequately determined, were distributed.",8/24/2007,"08/24/2007",7/31/2013,"07/31/2013"
"Biologics",45171,"Terminated","American National Red Cross (The)","Tucson","AZ","US","Voluntary: Firm Initiated","Letter","Arizona, California","B-1812-13","Class III","Blood and Blood Products for Reprocessing","007FC25436",,"1","Blood products, collected from a donor in whom donor suitability was not adequately determined, were distributed.",8/24/2007,"08/24/2007",7/31/2013,"07/31/2013"
"Biologics",45172,"Terminated","Southern California Permanente Medical Group Blood Donor Center","Irvine","CA","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","CA","B-1695-13","Class II","Red Blood Cells","KJ43504I; KJ43504II",".","2 units","Blood products, collected from a donor who was at risk for variant Creutzfeldt-Jakob disease (vCJD), were distributed.",9/5/2007,"09/05/2007",8/28/2013,"08/28/2013"
"Biologics",45174,"Terminated","San Diego Blood Bank","San Diego","CA","US","Voluntary: Firm Initiated","Telephone","California","B-2324-13","Class II","Red Blood Cells (Apheresis)","KP77163; KP77163",,"2 units","Blood products, possibly air contaminated, were distributed.",9/8/2007,"09/08/2007",11/6/2013,"11/06/2013"
"Biologics",45175,"Terminated","San Diego Blood Bank","San Diego","CA","US","Voluntary: Firm Initiated","Telephone","California","B-2244-13","Class III","Red Blood Cells Leukocytes Reduced","KP75541",".","1 unit","Blood product, collected from a donor whose body temperature was not documented, was distributed.",9/29/2007,"09/29/2007",9/11/2013,"09/11/2013"
"Biologics",45176,"Terminated","Talecris Plasma Resources Inc Dba International Bioresources","Research Triangle Park","NC","US","Voluntary: Firm Initiated","FAX","North Carolina","B-1798-13","Class III","Source Plasma","368059868",".","1","Blood product, collected from a donor whose arm inspection was not documented, was distributed.",8/20/2007,"08/20/2007",7/24/2013,"07/24/2013"
"Biologics",45177,"Terminated","Talecris Plasma Resources Inc Dba International Bioresources","Research Triangle Park","NC","US","Voluntary: Firm Initiated","FAX","North Carolina","B-1668-13","Class II","Source Plasma","368066965",".","1 unit","Blood product, collected from a donor for whom donor suitability was not adequately determined, was distributed.",8/27/2007,"08/27/2007",7/24/2013,"07/24/2013"
"Biologics",45178,"Terminated","HemaCare Corporation","Van Nuys","CA","US","Voluntary: Firm Initiated","Telephone","California","B-2403-13","Class II","Red Blood Cells","4035495",".","1 unit","Blood product, collected from a donor for whom donor suitability was not adequately determined, was distributed.",2/7/2006,"02/07/2006",10/2/2013,"10/02/2013"
"Biologics",45179,"Terminated","HemaCare Corporation","Van Nuys","CA","US","Voluntary: Firm Initiated","Letter","California","B-1503-13","Class II","Red Blood Cells","FS14433",".","1","Blood product, collected from a donor during a one year period of deferral for travel to a malarial endemic area.",9/14/2007,"09/14/2007",8/14/2013,"08/14/2013"
"Biologics",45180,"Terminated","BioLife Plasma Services L.P.","Van Nuys","CA","US","Voluntary: Firm Initiated","Telephone","California","B-2178-13","Class II","Source Plasma","07JTN10479; 07JTN11037; 07JTN11121",,"3","Blood products, collected from a donor who was previously HIV-1/2 reactive, were distributed. ",7/27/2007,"07/27/2007",9/25/2013,"09/25/2013"
"Biologics",45280,"Terminated","American National Red Cross (The)","West Henrietta","NY","US","Voluntary: Firm Initiated","FAX","New York","B-0840-13","Class II","Red Blood Cells Leukocytes Reduced","01KK28241",".","1","Blood products, collected from a donor whose suitability to donate was not adequately determined, were distributed. ",8/1/2007,"08/01/2007",4/10/2013,"04/10/2013"
"Biologics",45280,"Terminated","American National Red Cross (The)","West Henrietta","NY","US","Voluntary: Firm Initiated","FAX","New York","B-0841-13","Class III","Blood and Blood Products for Reprocessing","01KK28241",".","1","Blood products, collected from a donor whose suitability to donate was not adequately determined, were distributed. ",8/1/2007,"08/01/2007",4/10/2013,"04/10/2013"
"Biologics",45280,"Terminated","American National Red Cross (The)","West Henrietta","NY","US","Voluntary: Firm Initiated","FAX","New York","B-0839-13","Class II","Platelets","01KK28241",".","1","Blood products, collected from a donor whose suitability to donate was not adequately determined, were distributed. ",8/1/2007,"08/01/2007",4/10/2013,"04/10/2013"
"Biologics",45352,"Terminated","University of Texas Medical Branch at Galveston (The)","Galveston","TX","US","Voluntary: Firm Initiated","Telephone","TX","B-0372-13","Class II","Red Blood Cells","4066720",".","1 unit","Blood product, collected from a donor whose suitability to donate was not adequately determined, was distributed.",7/24/2007,"07/24/2007",1/23/2013,"01/23/2013"
"Biologics",45357,"Terminated","LifeServe Blood Center","Des Moines","IA","US","Voluntary: Firm Initiated","Letter","Iowa","B-0744-13","Class II","Red Blood Cells Leukocytes Reduced","LE99344",,"1 Unit","Blood product, positive for the c-antigen but labeled as c-antigen negative, was distributed.",9/13/2007,"09/13/2007",3/13/2013,"03/13/2013"
"Biologics",45449,"Terminated","Cangene Corporation - Rh Plasma Center","Winnipeg","MB","CA","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Canada","B-1062-13","Class II","Source Plasma","RH0019179",".","1 unit","Blood product, quality control and distribution/required testing not performed for HIV/HCV Nucleic Acid Test (NAT), was distributed.",5/24/2007,"05/24/2007",5/15/2013,"05/15/2013"
"Biologics",45629,"Terminated","The Blood Alliance, Inc.","Jacksonville","FL","US","Voluntary: Firm Initiated","Letter","FL","B-1287-13","Class II","Red Blood Cells Leukocytes Reduced","6452907",".","1 unit","Blood products, collected from a donor who traveled to a malarial endemic area, were distributed. ",8/28/2007,"08/28/2007",7/10/2013,"07/10/2013"
"Biologics",45700,"Terminated","Blood Systems, Inc.","El Paso","TX","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","AZ, TX, NM, AL, MS, UK, Switzerland","B-2255-13","Class II","Red Blood Cells (Apheresis) Leukocytes Reduced","110024204;110024208;110024213;110024214;110024348;110024355;110024604;110024609;110024620;110024633;110024959;110026496;110027061;110027089;110027108;110027121;110027126;110027140;110027147;110027666;110027831;114492112;114492120;114492122;114492548;114492553;114492563;114492675;114493511;114493516;114493520;114493865;114493950;114493968;114493971;114493977;114493981;114495337;114495620;114495628;114495630;114495634;114495698;114495701;114495704;114495706;114496197;114497529;114497538;114498443;110024204;110024213;110024214;110024348;110024355;110024604;110024617;110024620;110024633;110024637;110024959;110026496;110027061;110027089;110027108;110027121;110027126;110027140;110027147;110027666;110027831;114492112;114492120;114492122;114492548114492553;114492563;114492675;114493511;114493516;114493865;114493950;114493968;114493977;114493981;114495337;114495628;114495630;114495634;114495698;114495701;114495704;114495706;114496197;114497529;114497538;114498443;",,"97 units","Blood products, collected from donors, whose suitability to donate was not adequately determined, were distributed.",9/12/2007,"09/12/2007",9/25/2013,"09/25/2013"
"Biologics",45700,"Terminated","Blood Systems, Inc.","El Paso","TX","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","AZ, TX, NM, AL, MS, UK, Switzerland","B-2257-13","Class II","Red Blood Cells Leukocytes Reduced","110024634;110024951;110027094;110027677;114492681;114493518;114493859;114493975;110024637;114493870;114493870;110024346;110024353;110024611;110024624;110024625;110024628;110024641;110024644;110024955;110024957;110024961;110024966;110025100;110025349;110025360;110026485;110026486;110026490;110026494;110026502;110026506;110026507;110026512;110026513;110026821;110026825;110026838;110026845;110027152;110027649;110027655;110027658;110027660;110027669;110027672;110027678;110027683;110027817;110027820;110027827;110027836;110027888;110028273;114482672;114492113;114492123;114492545;114492556;114492566;114492570;114492574;114492576;114492685;114493509;114493512;114493523;114493525;114493527;114493856;114493857;114493867;114493872;114493873;114493899;114493901;114493953;114493957;114493961;114493963;114493979;114493986;114495340;114495342;114495344;114495347;114495350;114495352;114495359;114495662;114495673;114495680;114495684;114495694;114495695;114495697;114495707;114497533;114497542;114497544;114498316;114498318;114498320;114498323;114498442;114498446;114498448;114498451;114498764;114498768;114492110",,"111 units","Blood products, collected from donors, whose suitability to donate was not adequately determined, were distributed.",9/12/2007,"09/12/2007",9/25/2013,"09/25/2013"
"Biologics",45700,"Terminated","Blood Systems, Inc.","El Paso","TX","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","AZ, TX, NM, AL, MS, UK, Switzerland","B-2258-13","Class II","Fresh Frozen Plasma","110024208;114493971;110024208;114493971;110024611;110024624;110024625;110024628;110024634;110024955;110025100;110026494;110026838;110026845;110027649;110027655;110027677;110027678;110027833;114493512;114493527;114493953;114493957;114495340;114495342;114495347;114495662;114497533;114498448;1144925620;110024350;110024641;110024644;110024966;110026486;110026490;110026502;110026507;110026513;110027568;110027660;110027669;110027672;110027683;114482672;114492110;114492545;114492556;114492566;114492574;114492685;114493509;114493518;114493523;114493525;114493856;114493857;114493859;11493867;114493872;114493873;114493899;114493901;114493961;114493963;114493975;114493979;114493986;114495350;114495352;114495359;114495673;114495680;114495684;114495694;114495695;114495697;114497542;114497544;114498316;114498318;114498320;114498323;114498768;114492123;114492570;114492576;114492681;114495344;114495707;114498764",,"91 units","Blood products, collected from donors, whose suitability to donate was not adequately determined, were distributed.",9/12/2007,"09/12/2007",9/25/2013,"09/25/2013"
"Biologics",45700,"Terminated","Blood Systems, Inc.","El Paso","TX","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","AZ, TX, NM, AL, MS, UK, Switzerland","B-2256-13","Class III","Blood and Blood Products for Reprocessing","110026491(Part A); 110026491(Part B); 110026496; 10026498 ",,"4 units","Blood products, collected from donors, whose suitability to donate was not adequately determined, were distributed.",9/12/2007,"09/12/2007",9/25/2013,"09/25/2013"
"Biologics",45715,"Terminated","Blood Center of Iowa (The)","Des Moines","IA","US","Voluntary: Firm Initiated","Letter","IA,","B-0859-13","Class II","Platelets pooled Leukocytes Reduced Irradiated","LX66756",".","1","Blood products, collected from a donor possibly at increased risk for Creutzfeldt-Jakob Disease (CJD), were distributed. ",9/22/2007,"09/22/2007",4/10/2013,"04/10/2013"
"Biologics",45715,"Terminated","Blood Center of Iowa (The)","Des Moines","IA","US","Voluntary: Firm Initiated","Letter","IA,","B-0857-13","Class II","Plasma Frozen","LX66756",".","1 unit","Blood products, collected from a donor possibly at increased risk for Creutzfeldt-Jakob Disease (CJD), were distributed. ",9/22/2007,"09/22/2007",4/10/2013,"04/10/2013"
"Biologics",45715,"Terminated","Blood Center of Iowa (The)","Des Moines","IA","US","Voluntary: Firm Initiated","Letter","IA,","B-0858-13","Class II","Red Blood Cells Leukocytes Reduced","LX66756",".","1","Blood products, collected from a donor possibly at increased risk for Creutzfeldt-Jakob Disease (CJD), were distributed. ",9/22/2007,"09/22/2007",4/10/2013,"04/10/2013"
"Biologics",45721,"Terminated","BioLife Plasma Services L.P.","Springfield","MO","US","Voluntary: Firm Initiated","FAX","CA","B-0347-13","Class II","Source Plasma","06FMOD0209",".","1 unit","Blood product, identified as unsuitable due to a donor screening deviation, was distributed.",9/25/2007,"09/25/2007",1/9/2013,"01/09/2013"
"Biologics",45772,"Terminated","American National Red Cross","Portland","OR","US","Voluntary: Firm Initiated","Other","MA and OR","B-0097-13","Class II","Plasma Frozen","021KY12152",".","1 unit","Blood products, collected from a donor in which donor suitability was not adequately determined, were distributed.",9/14/2007,"09/14/2007",3/27/2013,"03/27/2013"
"Biologics",45772,"Terminated","American National Red Cross","Portland","OR","US","Voluntary: Firm Initiated","Other","MA and OR","B-0096-13","Class II","Red Blood Cells Leukocytes Reduced","021KY12152",".","1 unit","Blood products, collected from a donor in which donor suitability was not adequately determined, were distributed.",9/14/2007,"09/14/2007",3/27/2013,"03/27/2013"
"Biologics",45793,"Terminated","Community Blood Center of the Ozarks","Springfield","MO","US","Voluntary: Firm Initiated","FAX","Austria","B-0886-13","Class II","Blood and Blood Products for Reprocessing","6816934",".","1 Unit","Blood product, collected from a donor who reported post donation illness, was distributed.",9/26/2007,"09/26/2007",4/10/2013,"04/10/2013"
"Biologics",45833,"Terminated","Delta Blood Bank","Stockton","CA","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","CA.","B-1373-13","Class II","Red Blood Cells","V71278",".","1 unit","Blood product, which was collected from a donor who traveled to a malarial endemic area, was distributed.",8/27/2007,"08/27/2007",6/19/2013,"06/19/2013"
"Biologics",45834,"Terminated","Delta Blood Bank","Stockton","CA","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","CA.","B-1374-13","Class II","Red Blood Cells","K14065",".","1 unit","Blood product, which was collected from a donor who traveled to a malarial endemic area, was distributed.",9/1/2007,"09/01/2007",6/19/2013,"06/19/2013"
"Biologics",46005,"Terminated","The American National Red Cross South Carolina Region","Columbia","SC","US","Voluntary: Firm Initiated","Telephone","AL","B-0995-13","Class III","Red Blood Cells (Apheresis) Leukocytes Reduced","26GE17710; 26GE17710",,"2 units","Blood products, which failed to meet the minimum specification for product volume, were distributed.",10/10/2007,"10/10/2007",4/17/2013,"04/17/2013"
"Biologics",46052,"Terminated","American National Red Cross (The)","West Henrietta","NY","US","Voluntary: Firm Initiated","Letter","NY","B-1200-13","Class II","Red Blood Cells Leukocytes Reduced","01KF03482",".","1 unit","Blood product, collected from a donor who traveled to an area considered endemic for malaria, was distributed.",10/4/2007,"10/04/2007",5/1/2013,"05/01/2013"
"Biologics",46053,"Terminated","American National Red Cross (The)","West Henrietta","NY","US","Voluntary: Firm Initiated","FAX","PA; CA","B-1739-13","Class II","Red Blood Cells Leukocytes Reduced","01E91070",,"1 unit","Blood products, in which donor screening and records were incomplete or incorrect and, were distributed.",10/23/2007,"10/23/2007",8/21/2013,"08/21/2013"
"Biologics",46053,"Terminated","American National Red Cross (The)","West Henrietta","NY","US","Voluntary: Firm Initiated","FAX","PA; CA","B-1738-13","Class III","Blood and Blood Products for Reprocessing","01E91070",,"1 unit","Blood products, in which donor screening and records were incomplete or incorrect and, were distributed.",10/23/2007,"10/23/2007",8/21/2013,"08/21/2013"
"Biologics",46057,"Terminated","Lane Memorial Blood Bank","Eugene","OR","US","Voluntary: Firm Initiated","FAX","TN","B-1291-13","Class II","Red Blood Cells Leukocytes Reduced","7137125",".","1 unit","Blood product, which were collected from a donor who traveled to a malarial endemic area, was distributed.",10/25/2007,"10/25/2007",7/10/2013,"07/10/2013"
"Biologics",46086,"Terminated","Community Blood Centers of South Florida, Inc.","Lauderhill","FL","US","Voluntary: Firm Initiated","Telephone","Florida","B-1523-13","Class II","Platelets Leukocytes Reduced Irradiated","2528930A; 2528930B.",,"2","Blood product, possibly contaminated with bacteria, was distributed. ",10/23/2007,"10/23/2007",7/3/2013,"07/03/2013"
"Biologics",46127,"Terminated","American National Red Cross (The)","Tucson","AZ","US","Voluntary: Firm Initiated","Letter","Arizona","B-2537-13","Class II","Red Blood Cells Leukocytes Reduced Irradiated","007FJ94213; 007FQ43738 ",".","2","Blood products, collected from a donor who traveled to an area considered endemic for malaria, were distributed. ",10/6/2007,"10/06/2007",10/30/2013,"10/30/2013"
"Biologics",46127,"Terminated","American National Red Cross (The)","Tucson","AZ","US","Voluntary: Firm Initiated","Letter","Arizona","B-2538-13","Class II","Red Blood Cells Leukocytes Reduced","007FK98535;007GQ24832;007FQ44104;007FE46653; 007FJ93898;007FJ94001;007FJ94015;007FQ43731; 007FK98533 ",".","9","Blood products, collected from a donor who traveled to an area considered endemic for malaria, were distributed. ",10/6/2007,"10/06/2007",10/30/2013,"10/30/2013"
"Biologics",46128,"Terminated","Blood Bank of San Bernardino and Riverside Counties","San Bernardino","CA","US","Voluntary: Firm Initiated","Letter","California","B-2006-13","Class III","Red Blood Cells Leukocytes Reduced Irradiated","GW82775; GW82775; GW82775; GW82775",".","4 units","Blood products, not prepared in accordance with specifications, were distributed.",11/15/2007,"11/15/2007",8/28/2013,"08/28/2013"
"Biologics",46133,"Terminated","Community Blood Center of the Ozarks","Springfield","MO","US","Voluntary: Firm Initiated","Letter","North Carolina; Missouri;","B-0746-13","Class II","Red Blood Cells Leukocytes Reduced","6819346",,"1 Unit","Blood products, which were collected from a donor who traveled to a malarial endemic area, were distributed.",10/22/2007,"10/22/2007",3/13/2013,"03/13/2013"
"Biologics",46133,"Terminated","Community Blood Center of the Ozarks","Springfield","MO","US","Voluntary: Firm Initiated","Letter","North Carolina; Missouri;","B-0745-13","Class II","Red Blood Cells","6798040",,"1 Unit","Blood products, which were collected from a donor who traveled to a malarial endemic area, were distributed.",10/22/2007,"10/22/2007",3/13/2013,"03/13/2013"
"Biologics",46436,"Terminated","The American National Red Cross South Carolina Region","Columbia","SC","US","Voluntary: Firm Initiated","Telephone","SC","B-0984-13","Class II","Platelets Pheresis Leukocytes Reduced","36FJ16721;36FJ16721",,"2 units","Blood products, where quality control and distribution of products did not meet specifications, were distributed.",10/19/2007,"10/19/2007",4/17/2013,"04/17/2013"
"Biologics",46459,"Terminated","Community Blood Centers of South Florida, Inc.","Lauderhill","FL","US","Voluntary: Firm Initiated","Telephone","Florida","B-1505-13","Class III","Platelets Pheresis Leukocytes Reduced Irradiated","2418777",".","2","Blood products, possibly contaminated with bacteria, were distributed.",11/26/2007,"11/26/2007",6/19/2013,"06/19/2013"
"Biologics",46461,"Terminated","Community Blood Centers of South Florida, Inc.","Lauderhill","FL","US","Voluntary: Firm Initiated","Telephone","Florida","B-1230-13","Class II","Platelets Leukocytes Reduced Irradiated","2411524B",,"1","Blood product, with an unacceptable platelet yield, was distributed.",10/18/2007,"10/18/2007",5/8/2013,"05/08/2013"
"Biologics",46484,"Terminated","Hoxworth Blood Center University of Cincinnati Medical Center","Cincinnati","OH","US","Voluntary: Firm Initiated","Telephone","OH","B-1527-13","Class II","Red Blood Cells Leukocytes Reduced","2904512",".","1 unit","Blood products, which were not quarantined subsequent to receiving information regarding a post donation illness, were distributed.",9/28/2007,"09/28/2007",7/10/2013,"07/10/2013"
"Biologics",46484,"Terminated","Hoxworth Blood Center University of Cincinnati Medical Center","Cincinnati","OH","US","Voluntary: Firm Initiated","Telephone","OH","B-1528-13","Class II","Platelets","2904512",".","1 unit","Blood products, which were not quarantined subsequent to receiving information regarding a post donation illness, were distributed.",9/28/2007,"09/28/2007",7/10/2013,"07/10/2013"
"Biologics",46535,"Terminated","Blood Center of Iowa (The)","Des Moines","IA","US","Voluntary: Firm Initiated","Letter","IA","B-0880-13","Class II","Plasma Frozen","FC12507",".","1 unit","Blood products, collected from a donor who reported a post donation illness, were distributed.",11/4/2007,"11/04/2007",4/10/2013,"04/10/2013"
"Biologics",46535,"Terminated","Blood Center of Iowa (The)","Des Moines","IA","US","Voluntary: Firm Initiated","Letter","IA","B-0879-13","Class II","Red Blood Cells Leukocytes Reduced","FC12507",".","1 unit","Blood products, collected from a donor who reported a post donation illness, were distributed.",11/4/2007,"11/04/2007",4/10/2013,"04/10/2013"
"Biologics",46543,"Terminated","American Red Cross Blood Services","Saint Louis","MO","US","Voluntary: Firm Initiated","Letter","Missouri","B-0570-13","Class II","Platelets Pheresis Leukocytes Reduced","011LK58056",,"1 Unit","Blood products, manufactured from an apheresis unit with platelet yield that did not meet the criteria for a divided unit, were distributed.",11/14/2007,"11/14/2007",3/6/2013,"03/06/2013"
"Biologics",46548,"Terminated","American National Red Cross (The)","Omaha","NE","US","Voluntary: Firm Initiated","FAX","NE, KS, CA, PA, AZ, NC, MN","B-0824-13","Class III","Platelets Pheresis Leukocytes Reduced Irradiated","GP27458; GP27465",,"2","Blood products, in which QC was not performed or unacceptable for West Nile Virus, were distributed.",11/8/2007,"11/08/2007",4/17/2013,"04/17/2013"
"Biologics",46548,"Terminated","American National Red Cross (The)","Omaha","NE","US","Voluntary: Firm Initiated","FAX","NE, KS, CA, PA, AZ, NC, MN","B-0822-13","Class III","Red Blood Cells-Leukocytes Reduced","FM51751; FZ70110; FZ70176; FZ70179; FZ70180; FZ70181; FZ70182; FZ70190; FZ70192; FZ70193; FZ70195; FZ70197; FZ70202; FZ70203; FZ70206; FZ70207; GJ88089; GJ88092; GJ88096; GR12284 ",,"20 units","Blood products, in which QC was not performed or unacceptable for West Nile Virus, were distributed.",11/8/2007,"11/08/2007",4/17/2013,"04/17/2013"
"Biologics",46548,"Terminated","American National Red Cross (The)","Omaha","NE","US","Voluntary: Firm Initiated","FAX","NE, KS, CA, PA, AZ, NC, MN","B-0821-13","Class III","Platelets Pheresis Leukocytes Reduced","09FC20679; 09FC20682; 09FC20681; 09FC20687; 09FC20689; 09FC20688; 09FC20686; 09FC20692; 09FC20685; 09FC20683; 09FC20680; FC20691; FC20693; FC20694; FC20695; FC20696; FC20697; FC20698; FC20699; FC20700; FC2070001; FC20702; FC20703; FC20704; FC20705; GL22503; GL22504; GL22505; GL22506; GL22507; GL22508; GL22509; GP27459; GP27462; GP27463; GP27467; GP27468; GP27470; GZ10224; GZ10228",,"40 units","Blood products, in which QC was not performed or unacceptable for West Nile Virus, were distributed.",11/8/2007,"11/08/2007",4/17/2013,"04/17/2013"
"Biologics",46548,"Terminated","American National Red Cross (The)","Omaha","NE","US","Voluntary: Firm Initiated","FAX","NE, KS, CA, PA, AZ, NC, MN","B-0825-13","Class III","Granulocytes Pheresis","GP27460",,"1 unit","Blood products, in which QC was not performed or unacceptable for West Nile Virus, were distributed.",11/8/2007,"11/08/2007",4/17/2013,"04/17/2013"
"Biologics",46548,"Terminated","American National Red Cross (The)","Omaha","NE","US","Voluntary: Firm Initiated","FAX","NE, KS, CA, PA, AZ, NC, MN","B-0823-13","Class III","Red Blood Cells","FS15612; FS15613; FS15614; FS15615; FS15616; FS15617; FZ0183; FZ70186; FZ70187; FZ70188; FZ70191; FZ70201; FZ70208; GR12286 ",,"14 units","Blood products, in which QC was not performed or unacceptable for West Nile Virus, were distributed.",11/8/2007,"11/08/2007",4/17/2013,"04/17/2013"
"Biologics",46550,"Terminated","American Red Cross Blood Services","Wichita","KS","US","Voluntary: Firm Initiated","FAX","Kansas; Oklahoma; Texas","B-2253-13","Class III","Red Blood Cells Leukocytes Reduced","02GJ05218;02GJ05251;02E32153;02GJ05203;02K09857; 02GJ05235;02K09839;02GJ05204;02GJ05207;02GJ05201; 02FE46227;02K09807;02GJ05241;02GJ05216;02FZ28706; 02GJ05202;02FE46218;02FE46208;02K09834;02GJ05242; 02GJ05244;02FE46253;02FE46223;02K09806;02K09841; 02K09836;02FE46255;02FE46249;02FE46222;02GJ05211; 02GJ05248;02K09819;02FE46246;02FE46252;02FZ28710; 02GJ05205;02FE46229;02FE46220;02FE46221;02FE46232; 02FE46213;02FE46236;02FE46216;02K09884;02K09818; 02K09810;02K09815;02K09870;02GJ05181;02FE46237; 02K09845;02K09844;02K09887;02GJ05196;02GJ05186; 02GJ05179;02FE46174;02GJ05221;02GJ05236;02GJ05214; 02K09879;02FE46193;02K09816;02K09792;02GJ05213; 02GJ05185;02K09804;02K09862;02K09871;02FZ28708; 02FZ28713;02GJ05280;02GJ05188;02GJ05194;02GJ05233; 02GJ05231;02K09787;02GJ05229;02GJ05224;05GJ05212; 02GJ05228;02GJ05215;02GJ05226;02GJ05232;02K09786; 02K09785;02K09780;02K09803;02GJ05239;02K09782; 02GJ05240;02K09783;02K09808;02K09797;02FE46257; 02FE46241;02FE46256;02FE46250;02FE46239;02FE46243; 02FE46238;02FZ28709;02FZ28704;02FZ28712;02GJ05190; 02GJ05206;02GJ05189;02GJ05184;02FE46198;02FE46189; 02FE46195;02FE46190;02FE46196;02FE46206;02FE46201; 02FE46187;02FE46192;02FE46197;02FE46204;02FE46224; 02FE46210;02FE46211;02FE46254;02FE46217;02FE46233; 02FE46248;02K09880;02K09881;02K09883;02K09885; 02K09856;02K09852;02K09863;02K09875;02FE46180; 02K09811;02K09795;02K09828;02K09835;02K09843; 02K09850;02K09793;02K09798;02K09809;02K09860; 02K09865;02K09858;02K09876;02FE46181;02FE46172; 02FE46183;02E32152;02FE46168;02FE46178;02K09822; 02K08848;02K09833;02K09825",,"158 Units","Blood products, in which viral testing/testing performed, interpreted, or documented incorrectly, were distributed. ",11/21/2007,"11/21/2007",9/25/2013,"09/25/2013"
"Biologics",46550,"Terminated","American Red Cross Blood Services","Wichita","KS","US","Voluntary: Firm Initiated","FAX","Kansas; Oklahoma; Texas","B-2254-13","Class III","Red Blood Cells Leukocytes Reduced Irradiated","02FE46203; 02FZ28716; 02FE46205; 02FE46194; 02E32155; 02K09826; 02K09836",,"7 Units","Blood products, in which viral testing/testing performed, interpreted, or documented incorrectly, were distributed. ",11/21/2007,"11/21/2007",9/25/2013,"09/25/2013"
"Biologics",46553,"Terminated","Blood Systems, Inc.","Scottsdale","AZ","US","Voluntary: Firm Initiated","Letter","AZ","B-2159-13","Class III","Platelets Pheresis Leukocytes Reduced","103043006",".","1","Blood product, possibly contaminated with P.acne, was distributed.",12/21/2007,"12/21/2007",10/2/2013,"10/02/2013"
"Biologics",46554,"Terminated","Blood Systems, Inc.","Scottsdale","AZ","US","Voluntary: Firm Initiated","Letter","Arizona","B-2199-13","Class II","Platelets Pheresis Leukocytes Reduced Irradiated","103326325(Part A) ;103326325(Part B)",,"2 units","Blood products, which were possibly contaminated with Propionibacterium species, were distributed.",12/28/2007,"12/28/2007",9/4/2013,"09/04/2013"
"Biologics",46557,"Terminated","American National Red Cross (The)","Pomona","CA","US","Voluntary: Firm Initiated","Telephone","California","B-1821-13","Class II","Red Blood Cells Leukocytes Reduced","06GG78505;06GV43156",,"2 units","Blood products, which were collected from a donor in which donor suitability was not adequately determined, were distributed.",11/19/2007,"11/19/2007",7/31/2013,"07/31/2013"
"Biologics",46557,"Terminated","American National Red Cross (The)","Pomona","CA","US","Voluntary: Firm Initiated","Telephone","California","B-1820-13","Class III","Blood and Blood Products for Reprocessing","06GG78505;06GV43156",,"2 units","Blood products, which were collected from a donor in which donor suitability was not adequately determined, were distributed.",11/19/2007,"11/19/2007",7/31/2013,"07/31/2013"
"Biologics",46559,"Terminated","American National Red Cross (The)","Tucson","AZ","US","Voluntary: Firm Initiated","Letter","AZ","B-2541-13","Class II","Red Blood Cells Leukocytes Reduced","007FC32093; 007FJ93492; 07FQ43480; 07FQ43504; 007FY65994; 007FY66020;007FY66113;007FY66334; 007FY66339",".","9 units","Blood products, collected from a donor who traveled to an area considered endemic for malaria, were distributed.",10/23/2007,"10/23/2007",10/30/2013,"10/30/2013"
"Biologics",46559,"Terminated","American National Red Cross (The)","Tucson","AZ","US","Voluntary: Firm Initiated","Letter","AZ","B-2542-13","Class II","Red Blood Cells Leukocytes Reduced Irradiated","007FR30726 ",".","1","Blood products, collected from a donor who traveled to an area considered endemic for malaria, were distributed.",10/23/2007,"10/23/2007",10/30/2013,"10/30/2013"
"Biologics",46559,"Terminated","American National Red Cross (The)","Tucson","AZ","US","Voluntary: Firm Initiated","Letter","AZ","B-2540-13","Class II","Red Blood Cells (Apheresis) Leukocytes Reduced","007GG17861(1);007GG17861(2).",".","2 Units","Blood products, collected from a donor who traveled to an area considered endemic for malaria, were distributed.",10/23/2007,"10/23/2007",10/30/2013,"10/30/2013"
"Biologics",46569,"Terminated","Southern California Permanente Medical Group Blood Bank","San Diego","CA","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","CA","B-1803-13","Class II","Red Blood Cells","FV87754",".","1 unit","Blood product, which was collected from a donor who traveled to a malarial endemic area, was distributed. ",11/29/2007,"11/29/2007",7/17/2013,"07/17/2013"
"Biologics",46585,"Terminated","New York Blood Center, Inc.","New York","NY","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","N.Y.","B-0614-13","Class III","Platelets Pheresis Leukocytes Reduced","7571882",,"1 unit","Blood product, which was possibly contaminated with penicillium species, was distributed.",10/31/2007,"10/31/2007",2/20/2013,"02/20/2013"
"Biologics",46636,"Terminated","American National Red Cross","Portland","OR","US","Voluntary: Firm Initiated","Letter","California.","B-0735-13","Class II","Blood and Blood Products for Reprocessing","21LY18474",,"1 component","Blood product, collected from a donor who was at risk for variant Creutzfeldt-Jakob disease (vCJD), was distributed. ",11/29/2007,"11/29/2007",3/13/2013,"03/13/2013"
"Biologics",46637,"Terminated","American National Red Cross (The)","Portland","OR","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","MA, MD, OR, CA","B-1147-13","Class III","Red Blood Cell Leukocytes Reduced","021LM25919, 021LE24330, 021LE24332, 021LM25913, 021LM25917, 021LM25911, 021LM25914, 021LE24200, 021LE24187, 021LE24189, 021LE24329, 021LM25924, 021LE24331, 021LE24335, 021LE24338, 021LE24346, 021LM25906, 021LM25908, 021LM25915, 021LM25916, 021LM25918, 021LM25921, 021LM25922, 021LM25930, 021LM25932, 021LM25934, 021LE24214, 021LE24217, 021LE24188, 021LM25929, 21LE24345, 21LE24205, 021LE24191, 021LE24192, 021LE24349, 021LE24351, 021LE24352, 021LE24355, 021LE24209, 021LE24211, 021LE24216, 021LE24190, 021LE24207, 021LE24210, 021LE24343, 021LM25920, 21LE24213, 21LE24195, 21LE24188, 021LE24184, 021LE24186, 021LE24334, 021LE24341, 021LE24342, 021LE24182, 021LE24354, 021LE24199, 021LE24206, 021LE24183, 021LE24208, 021LE24340, 021LM25931, 021LM25935, 021LE24215, 021LE24344.",,"65 components","Expired Blood bags used. ",11/9/2007,"11/09/2007",5/22/2013,"05/22/2013"
"Biologics",46637,"Terminated","American National Red Cross (The)","Portland","OR","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","MA, MD, OR, CA","B-1146-13","Class III","Plasma Frozen","021LE24188, 021LM25906, 021LM25915, 021LM25918, 21LE24195, 021LE24211, 021LM25920. ",,"7 Components","Blood products, collected using expired blood collection sets, were distributed.",11/9/2007,"11/09/2007",5/22/2013,"05/22/2013"
"Biologics",46637,"Terminated","American National Red Cross (The)","Portland","OR","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","MA, MD, OR, CA","B-1145-13","Class III","Red Blood Cells Leukocytes Reduced Irradiated","021LE24198.",,"1 component","Blood products, collected using expired blood collection sets, were distributed. ",11/9/2007,"11/09/2007",5/22/2013,"05/22/2013"
"Biologics",46647,"Terminated","Community Blood Center of the Ozarks","Springfield","MO","US","Voluntary: Firm Initiated","Telephone","Arkansas","B-0779-13","Class III","Platelets Pheresis Leukocytes Reduced Irradiated","9929659",,"1 Unit","Blood product, that was irradiated twice, was distributed",11/21/2007,"11/21/2007",5/8/2013,"05/08/2013"
"Biologics",46664,"Terminated","HemaCare Corporation","Van Nuys","CA","US","Voluntary: Firm Initiated","Letter","California","B-2049-13","Class II","Fresh Frozen Plasma","3051339; 5082472; 3052917",".","3 units","Blood products, collected from a donor during a deferral period for travel to a malarial endemic area, were distributed.",11/7/2007,"11/07/2007",10/2/2013,"10/02/2013"
"Biologics",46664,"Terminated","HemaCare Corporation","Van Nuys","CA","US","Voluntary: Firm Initiated","Letter","California","B-2047-13","Class II","Red Blood Cells","3051339",".","1 unit","Blood products, collected from a donor during a deferral period for travel to a malarial endemic area, were distributed.",11/7/2007,"11/07/2007",10/2/2013,"10/02/2013"
"Biologics",46664,"Terminated","HemaCare Corporation","Van Nuys","CA","US","Voluntary: Firm Initiated","Letter","California","B-2048-13","Class II","Red Blood Cells Leukocytes Reduced","5082472; 3052917",".","2 units","Blood products, collected from a donor during a deferral period for travel to a malarial endemic area, were distributed.",11/7/2007,"11/07/2007",10/2/2013,"10/02/2013"
"Biologics",46672,"Terminated","American National Red Cross (The)","West Henrietta","NY","US","Voluntary: Firm Initiated","FAX","NY","B-0835-13","Class II","Cryoprecipitated AHF","LH85065",,"1 unit","Blood products, which were collected from a donor who traveled to a malarial endemic area, were distributed. ",11/7/2007,"11/07/2007",4/3/2013,"04/03/2013"
"Biologics",46672,"Terminated","American National Red Cross (The)","West Henrietta","NY","US","Voluntary: Firm Initiated","FAX","NY","B-0834-13","Class II","Red Blood Cells Leukocytes Reduced","LH85065",,"1 unit","Blood products, which were collected from a donor who traveled to a malarial endemic area, were distributed. ",11/7/2007,"11/07/2007",4/3/2013,"04/03/2013"
"Biologics",46676,"Terminated","The Blood Alliance, Inc.","Saint Augustine","FL","US","Voluntary: Firm Initiated","Telephone","FL","B-1661-13","Class III","Red Blood Cells Leukocytes Reduced","8604481; 8604477; 8604418; 1251960; 8604227; 7807516; 7807522; 8604129; 8604171; 7807314; 7806375; 7806344; 5924178; 7806218; 7806202, 7805994, 7805982, 7805959, 4805907, 8603589, 7805765, 7805758, 7805752, 4208542, 7426585, 8603492, 7805649, 7805593, 7805591, 7805542",".","30 units","Blood products, for which there was no documentation for the time period out of controlled storage, were distributed.",9/26/2007,"09/26/2007",7/10/2013,"07/10/2013"
"Biologics",46676,"Terminated","The Blood Alliance, Inc.","Saint Augustine","FL","US","Voluntary: Firm Initiated","Telephone","FL","B-1660-13","Class III","Red Blood Cells (Apheresis) Leukocytes Reduced","4826808; 7807745; 9870298, 9868793, 1957226. ",".","5 units","Blood products, for which there was no documentation for the time period out of controlled storage, were distributed.",9/26/2007,"09/26/2007",7/10/2013,"07/10/2013"
"Biologics",46980,"Terminated","The American National Red Cross South Carolina Region","Columbia","SC","US","Voluntary: Firm Initiated","Telephone","GA, SC","B-0997-13","Class III","Cryoprecipitated AHF","012X44022, 012X44024, 012X44013, 012X44016, 012X43541, 012X44006, 012GY07319, 012X43532, 012GY07315, 012GY07317, 012G07304, 012GY07310, 012E85978, 012FL38709, 012E85972, 012E85975, 012E85970, 012E85971, 012X44018, 012X44021, 012GY07303, 012GY07305, 012FL38043, 012GY07152, 012C82302, 012E85969, 012C82288, 012C82293, 012GY07322, 012K30342, 012K30354, 012K30356, 012K30362, 012K30364, 012L65504",,"35 units","Blood products, for which shipping and storage conditions were undocumented, were distributed.",11/14/2007,"11/14/2007",4/17/2013,"04/17/2013"
"Biologics",46980,"Terminated","The American National Red Cross South Carolina Region","Columbia","SC","US","Voluntary: Firm Initiated","Telephone","GA, SC","B-0998-13","Class III","Plasma Frozen","012GE97062, 012GE97066, 012GR97068, 012GE97070, 012GK59334, 012GK59341, 012KE11591, 012KE11593, 012KE11602, 012KE11605, 012FZ71992, 012KM26395, 012FY22926, 012FY22929, 012LW25039, 012FK0667, FN25400, 012FQ89358, 012FQ89362, 012FX12666, 012FJ00408, 012FX12671, 012FX12676, 012KE11610, 012KE11611, 012KE11616, 012KP07814 ",,"27 units","Blood products, for which shipping and storage conditions were undocumented, were distributed.",11/14/2007,"11/14/2007",4/17/2013,"04/17/2013"
"Biologics",46980,"Terminated","The American National Red Cross South Carolina Region","Columbia","SC","US","Voluntary: Firm Initiated","Telephone","GA, SC","B-0996-13","Class III","Red Blood Cells","009E19267, 009E19270, 009FF69669, 009FV35905, 009FV35910, 009FV35922, ",,"6 units","Blood products, for which shipping and storage conditions were undocumented, were distributed.",11/14/2007,"11/14/2007",4/17/2013,"04/17/2013"
"Biologics",46986,"Terminated","American National Red Cross (The)","Pomona","CA","US","Voluntary: Firm Initiated","Telephone","California","B-1967-13","Class II","Red Blood Cells Leukocytes Reduced","06GP73413",,"1","Blood products, collected from donors for whom donor suitability was not adequately determined, were distributed.",11/16/2007,"11/16/2007",7/31/2013,"07/31/2013"
"Biologics",46986,"Terminated","American National Red Cross (The)","Pomona","CA","US","Voluntary: Firm Initiated","Telephone","California","B-1968-13","Class II","Fresh Frozen Plasma","06GP73413",,"1","Blood products, collected from donors for whom donor suitability was not adequately determined, were distributed.",11/16/2007,"11/16/2007",7/31/2013,"07/31/2013"
"Biologics",47005,"Terminated","American National Red Cross (The)","West Henrietta","NY","US","Voluntary: Firm Initiated","Telephone","New York","B-1259-13","Class III","Red Blood Cells (Apheresis) Leukocytes Reduced","01GH09575; 01KS81880",".","2 units","Blood products, which may have been exposed to unacceptable temperature during storage, were distributed.",11/29/2007,"11/29/2007",6/5/2013,"06/05/2013"
"Biologics",47033,"Terminated","American National Red Cross","Portland","OR","US","Voluntary: Firm Initiated","Letter","Nationwide","B-1567-13","Class II","Red Blood Cells","21KS56466, 21KS56479, 21KS56483, 21KS56503, 21KS61478, 21KW47433, 21LC70594, 21LJ41078, 21LK29140, 21W71706, 21W71713, 21W71718, 21W71730, 21W71732, 21W71734, 21W71711, 21KW47408, 21KW47413, 21KS60140, 21KS68252, 21KS68255, 21KS68256, 21KS68257, 21LC70589, 21LC70613, 21LC70626, 21LC70637, 21LC70647, 21LC70660, 21W71695, 21W71696, 21W71723, 21W71728",,"33 units","Blood products, collected in a manner that may have compromised the sterility of the units, were distributed. ",1/18/2008,"01/18/2008",7/3/2013,"07/03/2013"
"Biologics",47033,"Terminated","American National Red Cross","Portland","OR","US","Voluntary: Firm Initiated","Letter","Nationwide","B-1568-13","Class II","Red Blood Cells Leukocytes Reduced Washed","21KS58453",,"1 unit","Blood products, collected in a manner that may have compromised the sterility of the units, were distributed. ",1/18/2008,"01/18/2008",7/3/2013,"07/03/2013"
"Biologics",47033,"Terminated","American National Red Cross","Portland","OR","US","Voluntary: Firm Initiated","Letter","Nationwide","B-1565-13","Class II","Red Blood Cells Leukocytes Reduced","21KS56402, 21KS56406, 21KS56409, 21KS56413, 21KS56414, 21KS56417, 21KS56419, 21KS56428, 21KS56431, 21KS56432, 21KS56433, 21KS56439, 21KS56443, 21KS56447, 21KS56455, 21KS56459, 21KS56460, 21KS56468, 21KS56470, 21KS56472, 21KS56473, 21KS56475, 21KS56477, 21KS56482, 21KS56487, 21KS56489, 21KS56490, 21KS56500, 21KS56506, 21KS56507, 21KS56512, 21KS56514, 21KS56515, 21KS56680, 21KS56685, 21KS56687, 21KS56691, 21KS56693, 21KS56703, 21KS56707, 21KS56711, 21KS56713, 21KS56720, 21KS56723, 21KS56726, 21KS56729, 21KS56732, 21KS56734, 21KS56739, 21KS56740, 21KS56745, 21KS56746, 21KS56755, 21KS56758, 21KS56763, 21KS56801, 21KS56803, 21KS57380, 21KS57382, 21KS57384, 21KS57385, 21KS57392, 21KS57394, 21KS57398, 21KS57399, 21KS57402, 21KS57403, 21KS57411, 21KS57414, 21KS57416, 21KS57419, 21KS57422, 21KS57427, 21KS57745, 21KS57753, 21KS57755, 21KS57760, 21KS57762, 21KS57766, 21KS57772, 21KS57779, 21KS57780, 21KS57784, 21KS57806, 21KS57807, 21KS57810, 21KS57815, 21KS57828, 21KS57832, 21KS57833, 21KS57836, 21KS57838, 21KS57840, 21KS57843, 21KS57845, 21KS57853, 21KS57854, 21KS57856, 21KS57857, 21KS57858, 21KS58221, 21KS58224, 21KS58228, 21KS58231, 21KS58245, 21KS58249, 21KS58255, 21KS58259, 21KS58264, 21KS58271, 21KS58274, 21KS58277, 21KS58283, 21KS58285, 21KS58290, 21KS58292, 21KS58334, 21KS58337, 21KS58339, 21KS58343, 21KS58355, 21KS58356, 21KS58358, 21KS58361, 21KS58365, 21KS58370, 21KS58372, 21KS58376, 21KS58379, 21KS58383, 21KS58389, 21KS58392, 21KS58398, 21KS58401, 21KS58403, 21KS58407, 21KS58410, 21KS58413, 21KS58421, 21KS58422, 21KS58426, 21KS58429, 21KS58431, 21KS58434, 21KS58435, 21KS58441, 21KS58442, 21KS58445, 21KS58450, 21KS58456, 21KS58459, 21KS58463, 21KS58466, 21KS58467, 21KS58471, 21KS58473, 21KS58483, 21KS58495, 21KS58496, 21KS58500, 21KS58504, 21KS58507, 21KS58509, 21KS58730, 21KS58734, 21KS58748, 21KS58750, 21KS58767, 21KS58769, 21KS58775, 21KS58779, 21KS58792, 21KS58795, 21KS58803, 21KS58806, 21KS58820, 21KS58831, 21KS58833, 21KS58835, 21KS58837, 21KS58842, 21KS58846, 21KS58849, 21KS58851, 21KS58855, 21KS58857,"," 21W73273, 21W73274, 21W73276, 21W73278, 21W73281, 21W73385, 21W73389, 21W73395, 21W73397, 21W73398, 21W73400, 21W73401, 21W73402, 21W73404, 21W73406, 21W73407, 21W73542, 21W73544, 21W73547, 21W73548, 21W73550, 21W73554, 21W73555, 21W73558, 21W73559, 21W73564, 21W73567, 21W73570, 21W73572, 21W73575, 21W75335, 21W75338, 21W75341, 21W75342, 21W75348, 21W75349, 21W75350, 21W75352, 21W75356, 21W75365, 21W75366, 21W78807, 21W78810, 21W78812, 21W78814, 21W78815, 21W78820, 21W78824, 21W79023, 21W79024, 21W79728, 21W79734, 21W79736, 21W79739, 21W79741, 21W79755, 21W79854, 21W79856, 21W79865, 21W80063","2983 units","Blood products, collected in a manner that may have compromised the sterility of the units, were distributed. ",1/18/2008,"01/18/2008",7/3/2013,"07/03/2013"
"Biologics",47033,"Terminated","American National Red Cross","Portland","OR","US","Voluntary: Firm Initiated","Letter","Nationwide","B-1569-13","Class II","Red Blood Cells Leukocytes Reduced Irradiated","21KS58396, 21KS58499, 21KS60090, 21KS61430, 21KS61443, 21KS62656, 21KS64851, 21KS70967, 21KW49314, 21KW50110, 21KW50979, 21KW51223, 21KW51908, 21KW52471, 21KW53556, 21KW53584, 21KW55746, 21KW55747, 21KW59204, 21KW60255, 21KW60262, 21KW60416, 21LC70653, 21LC70665, 21LC71006, 21LC71358, 21LC72748, 21LC77819, 21LC78996, 21LC79018, 21LC79912, 21LC80778, 21LC80797, 21LC80815, 21LC80841, 21LC80851, 21LC82030, 21LC82039, 21LC82068, 21LC82590, 21LC82603, 21LC82635, 21LC82639, 21LC82655, 21LC84390, 21LC84421, 21LC84533, 21LC99782, 21LC99827, 21LG38733, 21LG41491, 21LG41502, 21LG57336, 21LG61071, 21LH45793, 21LK28673, 21W71843, 21W78825, 21KW55743, 21LC82054, 21LZ02609, 21KS62861, 21KS70719, 21KW48186, 21KW48953, 21KW49279, 21KW49609, 21KW49674, 21KW50056, 21KW50096, 21KW50603, 21KW51306, 21KW51318, 21KW52434, 21KW53076, 21KW53121, 21KW53462, 21KW53475, 21KW59234, 21KW59708, 21KW60266, 21KW61630, 21KW61682, 21LC70633, 21LC70925, 21LC71276, 21LC71612, 21LC72663, 21LC79006, 21LC82612, 21LC90862, 21LG41488, 21LG41498, 21LJ37189",,"94 units","Blood products, collected in a manner that may have compromised the sterility of the units, were distributed. ",1/18/2008,"01/18/2008",7/3/2013,"07/03/2013"
"Biologics",47033,"Terminated","American National Red Cross","Portland","OR","US","Voluntary: Firm Initiated","Letter","Nationwide","B-1566-13","Class II","Plasma Frozen","21KS56404, 21KS56409, 21KS56414, 21KS56419, 21KS56431, 21KS56455, 21KS56459, 21KS56470, 21KS56475, 21KS56707, 21KS56711, 21KS56713, 21KS56715, 21KS56726, 21KS56732, 21KS56745, 21KS56746, 21KS56801, 21KS58221, 21KS58224, 21KS58231, 21KS58255, 21KS58259, 21KS58264, 21KS58271, 21KS58274, 21KS58285, 21KS58292, 21KS58343, 21KS58355, 21KS58358, 21KS58370, 21KS58376, 21KS58379, 21KS58392, 21KS58398, 21KS58407, 21KS58413, 21KS58422, 21KS58426, 21KS58429, 21KS58431, 21KS58434, 21KS58435, 21KS58442, 21KS58445, 21KS58473, 21KS58496, 21KW47408, 21KW47413, 21KW47433, 21KW47509, 21KW47829, 21KW47831, 21KW47832, 21KW47836, 21KW47851, 21KW47852, 21KW47855, 21KW47856, 21KW47862, 21KW47863, 21KW48186, 21KW48187, 21KW48191, 21KW48196, 21KW48198, 21KW48208, 21KW49594, 21KW49784, 21KW49786, 21KW49793, 21KW49797, 21KW49809, 21KW49812, 21KW49814, 21KW49816, 21KW49825, 21KW49830, 21LC71021, 21LG38714, 21LG38715, 21LG38727, 21LG38737, 21LG39157, 21LG39158, 21LG39166, 21LG39173, 21LG39178, 21LG39182, 21LG39184, 21LG39189, 21LG39191, 21LG39193, 21LG39204, 21LJ34321, 21LJ34324, 21LJ34326, 21LJ34329, 21LJ34330, 21LJ34339, 21LK24472, 21LK25394, 21LK25414, 21LL17300, 21LV17002, 21LV17009, 21LV17014, 21W71707, 21W72793, 21KS56460, 21KS56720, 21KS56763, 21KS58507, 21KW49796, 21LG39199, 21W72039, 21KS58228, 21KS58249, 21KS58283, 21KS58383, 21KW47402, 21KW47414, 21KW47870, 21KW49592, 21KW49800, 21LC71222, 21LC71263, 21LG39154, 21LL17303, 21LL17310, 21KS58737, 21KS59645, 21KS59661, 21KS59680, 21KS59687, 21KS59695, 21KS59697, 21KS59702, 21KS59705, 21KS59709, 21KS59720, 21KS59722, 21KS59761, 21KS60037, 21KS60041, 21KS60044, 21KS60050, 21KS60057, 21KS60060, 21KS60063, 21KS60066, 21KS60068, 21KS60069, 21KS60084, 21KS60087, 21KS60090, 21KS60096, 21KS60109, 21KS60124, 21KS60129, 21KS60209, 21KS60210, 21KS60212, 21KS60445, 21KS60452, 21KS60463, 21KS60466, 21KS60468, 21KS61266, 21KS61273, 21KS61280, 21KS61309, 21KS61310, 21KS61321, 21KS61344, 21KS61345, 21KS61348, 21KS61417, 21KS61421, 21KS61424, 21KS61437, 21KS61475, 21KS61745, 21KS61747, 21KS61756, 21",,"429 units","Blood products, collected in a manner that may have compromised the sterility of the units, were distributed. ",1/18/2008,"01/18/2008",7/3/2013,"07/03/2013"
"Biologics",47033,"Terminated","American National Red Cross","Portland","OR","US","Voluntary: Firm Initiated","Letter","Nationwide","B-1572-13","Class II","Plasma Frozen Cryoprecipitate Reduced","21KS58803, 21KS59300, 21KS61529, 21KW49273, 21KW49279, 21KW49688, 21KW49706, 21KW50019, 21KW50061, 21KW50080, 21KW50110, 21KW50112, 21KW50114, 21KW50116, 21KW50508, 21KW50512, 21KW50513, 21KW50518, 21KW50539, 21KW50589, 21KW50634, 21KW50886, 21KW50914, 21KW50925, 21KW50927, 21KW50933, 21KW51259, 21KW51658, 21KW52605, 21KW52608, 21KW53096, 21KW53115, 21KW53456, 21KW53464, 21KW53475, 21KW53483, 21KW55487, 21LC71270, 21LC71272, 21LC71276, 21LC71297, 21LC71363, 21LC71377, 21LC71379, 21LC71568, 21LC71571, 21LC71594, 21LC71595, 21LC71612, 21LC71629, 21LC71682, 21LC71714, 21LC71771, 21LC73977, 21LC74050, 21LC74087, 21LC74093, 21LC74114, 21LC77812, 21LC77842, 21LC77854, 21LC78980, 21LC78982, 21LC82524, 21LC82612, 21LC82615, 21LC82639, 21LC82640, 21LC82656, 21LC84040, 21LC84245, 21LC84253, 21LC84390, 21LC84412, 21LC84533, 21LC84556, 21LC84565, 21LC84576, 21LC84616, 21LG38697, 21LG41513, 21LG41518, 21LG41524, 21LG41529, 21LG43944, 21LG44701, 21LG55864, 21LH44717, 21LH44724, 21LH44739, 21LH44747, 21LH44756, 21LH44761, 21LH44765, 21LH44770, 21LH45764, 21LH45767, 21LH45785, 21LJ37223, 21LJ37248, 21LJ41056, 21LJ41815, 21LJ41872, 21LJ54484, 21W72668, 21W72692, 21W72922, 21W73102, 21W73128, 21W73143, 21KW50890, 21KS57403, 21KS61521, 21KW49368, 21KW50949, 21KW50964, 21KW51252, 21LC79909, 21LC79993, 21LC91122, 21LJ42005, 21LJ44815, 21LK30442, 21KS58806, 21KS59245, 21KS59261, 21KS59332, 21KS59341, 21KS59366, 21KS59390, 21KS60894, 21KS61503, 21KS61527, 21KS61533, 21KS61551, 21KS61561, 21KS61616, 21KS61618, 21KS61638, 21KS61651, 21KS61669, 21KS62571, 21KS62588, 21KS62592, 21KS62595, 21KS69419, 21KW48175, 21KW48210, 21KW48331, 21KW49698, 21KW49705, 21KW50054, 21KW50078, 21KW50085, 21KW50088, 21KW50103, 21KW50132, 21KW50510, 21KW50529, 21KW50571, 21KW50730, 21KW50756, 21KW50907, 21KW50909, 21KW50911, 21KW50923, 21KW50952, 21KW50953, 21KW50955, 21KW50974, 21KW50979, 21KW51270, 21KW51273, 21KW51297, 21KW51306, 21KW51314, 21KW51318, 21KW52575, 21KW52581, 21KW52604, 21KW53276, 21KW55203, 21KW59052, 21KW59211, 21KW60217, 21KW60221, 21KW6",,"217 units","Blood products, collected in a manner that may have compromised the sterility of the units, were distributed. ",1/18/2008,"01/18/2008",7/3/2013,"07/03/2013"
"Biologics",47033,"Terminated","American National Red Cross","Portland","OR","US","Voluntary: Firm Initiated","Letter","Nationwide","B-1571-13","Class II","Cryoprecipitated AHF, Pooled","21KS57753 Pool 17274, 21KS57755 Pool 17274, 21KS57760 Pool 17275, 21KS58872 Pool 17553, 21KS58873 Pool 17554, 21KS61505 Pool 17952, 21KS61508 Pool 17952, 21KS61522 Pool 17952, 21KS61523 Pool 17953, 21KS62677 Pool 18251, 21KS62684 Pool 18250, 21KS62813 Pool 18270, 21KS62820 Pool 18269, 21KS62839 Pool 18264, 21KS62843 Pool18263, 21KS63743 Pool 18572, 21KS63751 Pool 18573, 21KS63763 Pool 18573, 21KW48174 Pool 17126, 21KW48927 Pool 17294, 21KW49580 Pool 17417, 21KW50012 Pool 17465, 21KW50108 Pool 17496, 21KW50294 Pool 17515, 21KW50512 Pool 17574, 21KW50513 Pool 17574, 21KW50531 Pool 17574, 21KW50583 Pool 17617, 21KW50608 Pool 17589, 21KW50621 Pool 17590, 21KW50637 Pool 17618, 21KW51199 Pool 17696, 21KW51202 Pool 17696, 21KW51209 Pool 17697, 21KW51211 Pool 17696, 21KW51221 Pool 17697, 21KW51668 Pool 17737, 21KW51670 Pool 17737, 21KW51671 Pool 17736, 21KW51762 Pool 17774, 21KW55230 Pool 18617, 21KW60239 Pool 19391, 21KW60260 Pool 19390, 21LC72759 Pool 17248, 21LC74047 Pool 17331, 21LC74050 Pool 17331, 21LC81997 Pool 17853, 21LC82039 Pool 17847, 21LC82077 Pool 17850, 21LC84443 Pool 18039, 21LC84521 Pool 18053, 21LC84553 Pool 18060, 21LC84556 Pool 18059, 21LC84560 Pool 18060, 21LC84578 Pool 18052, 21LC84587 Pool 18051, 21LC84611 Pool 18049, 21LC85088 Pool 18133, 21LC89844 Pool 18747, 21LC89847 Pool 18746, 21LG38754 Pool 17192, 21LG38760 Pool 17193, 21LG38960 Pool 17213, 21LG61017 Pool 19789, 21LG61046 Pool 19796, 21LG61052 Pool 19797, 21LJ41063 Pool 18091, 21LJ41069 Pool 18091, 21LJ41070 Pool 18091, 21LJ41116 Pool 18108, 21LJ41886 Pool 18163, 21LJ43947 Pool 18592, 21LJ46271 Pool 18931, 21LJ46274 Pool 18930, 21LJ54506 Pool 19604, 21LJ54508 Pool 19605, 21LK22468 Pool 16913, 21LK22496 Pool 16916, 21LK24516 Pool 17254, 21LK25331 Pool 17382, 21LK25335 Pool 17383, 21LK25342 Pool 17382, 21LK25399 Pool 17358, 21LK25408 Pool 17359, 21LK25411 Pool 17359, 21LK25415 Pool 17359, 21LK25442 Pool 17376, 21LK27844 Pool 17706, 21LK33908 Pool 18729, 21LK33943 Pool 18727, 21LK38585 Pool 18959, 21LK38590 Pool 18958, 21LK38596 Pool 18959, ",,"154 units","Blood products, collected in a manner that may have compromised the sterility of the units, were distributed. ",1/18/2008,"01/18/2008",7/3/2013,"07/03/2013"
"Biologics",47033,"Terminated","American National Red Cross","Portland","OR","US","Voluntary: Firm Initiated","Letter","Nationwide","B-1570-13","Class II","Cryoprecipitated AHF","21KS56479, 21KS56482, 21KS56483, 21KS56487, 21KS56512, 21KS57422, 21KS57766, 21KS57772, 21KS57784, 21KS57807, 21KS57810, 21KS57815, 21KS57828, 21KS57832, 21KS57836, 21KS57838, 21KS57840, 21KS57843, 21KS57845, 21KS57853, 21KS57856, 21KS57857, 21KS57858, 21KS58748, 21KS58767, 21KS58769, 21KS58775, 21KS58779, 21KS58792, 21KS58795, 21KS58803, 21KS58835, 21KS58842, 21KS58849, 21KS58860, 21KS58870, 21KS59265, 21KS59300, 21KS59318, 21KS59341, 21KS59352, 21KS59356, 21KS59359, 21KS59370, 21KS59385, 21KS59390, 21KS60890, 21KS60892, 21KS60895, 21KS60898, 21KS60900, 21KS60908, 21KS60910, 21KS60919, 21KS60921, 21KS61503, 21KS61511, 21KS61527, 21KS61531, 21KS61535, 21KS61536, 21KS61551, 21KS61561, 21KS61585, 21KS61592, 21KS61594, 21KS61596, 21KS61616, 21KS61639, 21KS61650, 21KS61651, 21KS61667, 21KS61669, 21KS62218, 21KS62220, 21KS62222, 21KS62229, 21KS62232, 21KS62234, 21KS62237, 21KS62239, 21KS62242, 21KS62567, 21KS62571, 21KS62577, 21KS62579, 21KS62584, 21KS62595, 21KS62624, 21KS62656, 21KS62705, 21KS62737, 21KS62761, 21KS62763, 21KS62776, 21KS62777, 21KS62783, 21KS62793, 21KS62801, 21KS62808, 21KS62834, 21KS62848, 21KS62851, 21KS62852, 21KS62861, 21KS62873, 21KS62875, 21KS62876, 21KS62879, 21KS63741, 21KS63755, 21KS63760, 21KS63761, 21KS63764, 21KS63769, 21KS63774, 21KS68022, 21KS68024, 21KS68026, 21KS68860, 21KS68861, 21KS69360, 21KS69382, 21KS69386, 21KS69387, 21KS69392, 21KS69418, 21KS69419, 21KS69423, 21KS69775, 21KS69826, 21KS69829, 21KS69843, 21KS69846, 21KS69848, 21KS69850, 21KS69855, 21KS70081, 21KS70089, 21KS70092, 21KS70114, 21KS70511, 21KS70513, 21KS70514, 21KS70702, 21KS70708, 21KS70719, 21KS70722, 21KS70725, 21KS70726, 21KS70729, 21KS70733, 21KS70744, 21KS70749, 21KS70754, 21KS71136, 21KS71140, 21KS71148, 21KS71184, 21KS71190, 21KS71194, 21KS71206, 21KS71219, 21KS71228, 21KS71239, 21KW47181, 21KW47185, 21KW47188, 21KW47191, 21KW47196, 21KW47200, 21KW47202, 21KW47206, 21KW47207, 21KW47208, 21KW47214, 21KW47216, 21KW47219, 21KW47220, 21KW47449, 21KW47452, 21KW47455, 21KW47459, 21KW47461, 21KW47464, 21KW47465,",,"1699 units","Blood products, collected in a manner that may have compromised the sterility of the units, were distributed. ",1/18/2008,"01/18/2008",7/3/2013,"07/03/2013"
"Biologics",47035,"Terminated","American National Red Cross","Portland","OR","US","Voluntary: Firm Initiated","Letter","California.","B-0719-13","Class II","Red Blood Cells Leukocytes Reduced","21FJ51269",,"1 component","Blood products, which were collected from a donor in which donor suitability was not adequately determined, were distributed.",12/7/2007,"12/07/2007",3/6/2013,"03/06/2013"
"Biologics",47035,"Terminated","American National Red Cross","Portland","OR","US","Voluntary: Firm Initiated","Letter","California.","B-0718-13","Class III","Blood and Blood Products for Reprocessing","21FJ51269",,"1 component","Blood products, which were collected from a donor in which donor suitability was not adequately determined, were distributed.",12/7/2007,"12/07/2007",3/6/2013,"03/06/2013"
"Biologics",47050,"Terminated","Community Blood Center Of Gtr KC","Kansas City","MO","US","Voluntary: Firm Initiated","Telephone","Missouri","B-0366-13","Class II","Platelets Pheresis Leukocytes Reduced","W045007915604",".","1 Unit","Blood product, which was possibly contaminated with Propionibacterium species, was distributed.",12/26/2007,"12/26/2007",1/23/2013,"01/23/2013"
"Biologics",47052,"Terminated","Community Blood Centers of South Florida, Inc.","Lauderhill","FL","US","Voluntary: Firm Initiated","Telephone","Florida","B-1390-13","Class II","Platelets Leukocytes Reduced","2409017",".","1 unit","Blood products, which was identified as being contaminated by the BacT/ALERT system, was distributed.",12/7/2007,"12/07/2007",6/19/2013,"06/19/2013"
"Biologics",47054,"Terminated","Community Blood Centers of South Florida, Inc.","Lauderhill","FL","US","Voluntary: Firm Initiated","Telephone","Florida, New York","B-1392-13","Class II","Platelets Leukocytes Reduced","2401160",".","1 unit","Blood products, which were identified as being contaminated by the BacT/ALERT system, were distributed.",12/16/2007,"12/16/2007",6/19/2013,"06/19/2013"
"Biologics",47054,"Terminated","Community Blood Centers of South Florida, Inc.","Lauderhill","FL","US","Voluntary: Firm Initiated","Telephone","Florida, New York","B-1391-13","Class II","Platelets Pheresis Leukocytes Reduced Irradiated","2401160",".","1 unit","Blood products, which were identified as being contaminated by the BacT/ALERT system, were distributed.",12/16/2007,"12/16/2007",6/19/2013,"06/19/2013"
"Biologics",47055,"Terminated","Community Blood Centers of South Florida, Inc.","Lauderhill","FL","US","Voluntary: Firm Initiated","Telephone","Florida","B-1393-13","Class II","Platelets Pheresis Leukocytes Reduced Irradiated","2409193(Part A); 2409193(Part B)",".","2 units","Blood products, which were identified as being contaminated by the BacT/ALERT system, were distributed.",12/21/2007,"12/21/2007",6/19/2013,"06/19/2013"
"Biologics",47061,"Terminated","American National Red Cross","Portland","OR","US","Voluntary: Firm Initiated","Letter","Oregon and California.","B-1279-13","Class II","Red Blood Cells Leukocytes Reduced","021FJ57141",".","1 component","Blood products, collected from a donor in whom donor suitability was not adequately determined, were distributed.",12/17/2007,"12/17/2007",6/12/2013,"06/12/2013"
"Biologics",47061,"Terminated","American National Red Cross","Portland","OR","US","Voluntary: Firm Initiated","Letter","Oregon and California.","B-1280-13","Class II","Plasma Frozen","021FJ57141",".","1 component","Blood products, collected from a donor in whom donor suitability was not adequately determined, were distributed.",12/17/2007,"12/17/2007",6/12/2013,"06/12/2013"
"Biologics",47073,"Terminated","Blood Bank of San Bernardino and Riverside Counties","San Bernardino","CA","US","Voluntary: Firm Initiated","Letter","California","B-1805-13","Class II","Red Blood Cells Leukocytes Reduced","GZ21115",".","1 unit","Blood products, collected from a donor who was at risk for variant Creutzfeldt-Jakob disease (vCJD), were distributed.",1/24/2008,"01/24/2008",7/17/2013,"07/17/2013"
"Biologics",47073,"Terminated","Blood Bank of San Bernardino and Riverside Counties","San Bernardino","CA","US","Voluntary: Firm Initiated","Letter","California","B-1804-13","Class III","Blood and Blood Products for Reprocessing","GZ21115",".","1 unit","Blood products, collected from a donor who was at risk for variant Creutzfeldt-Jakob disease (vCJD), were distributed.",1/24/2008,"01/24/2008",7/17/2013,"07/17/2013"
"Biologics",47084,"Terminated","International BioResources, LLC","Fort Worth","TX","US","Voluntary: Firm Initiated","FAX","NC","B-0643-13","Class III","Source Plasma","364009860; 364008845; 364007371; 364000437",".","4 units","Blood product, collected from a donor whose donor suitability was not adequately determined, was distributed.",1/5/2007,"01/05/2007",2/27/2013,"02/27/2013"
"Biologics",47085,"Terminated","Blood Systems, Inc.","Scottsdale","AZ","US","Voluntary: Firm Initiated","Letter","AZ","B-2158-13","Class II","Red Blood Cells (Apheresis) Leukocytes Reduced","101976580; 101976580",".","2","Blood products, collected from a donor taking the drug Avodart, were distributed.",1/24/2008,"01/24/2008",10/2/2013,"10/02/2013"
"Biologics",47102,"Terminated","LifeServe Blood Center","Sioux City","IA","US","Voluntary: Firm Initiated","Telephone","IA","B-0581-13","Class III","Red Blood Cells Leukocytes Reduced Irradiated","2150235",".","1 unit","Blood product, exposed to unacceptable shipping temperatures, was distributed.",12/31/2007,"12/31/2007",2/27/2013,"02/27/2013"
"Biologics",47109,"Terminated","Community Blood Centers of South Florida, Inc.","Lauderhill","FL","US","Voluntary: Firm Initiated","Telephone","Florida","B-1524-13","Class III","Platelets Leukocytes Reduced","2554004; 2554004 (split product)",,"2","Blood products, possibly contaminated with bacteria, were distributed.",12/24/2007,"12/24/2007",7/3/2013,"07/03/2013"
"Biologics",47114,"Terminated","LifeServe Blood Center","Des Moines","IA","US","Voluntary: Firm Initiated","Letter","Iowa, Michigan","B-0888-13","Class III","Blood and Blood Products for Reprocessing","LQ10869",,"1 unit","Blood products, collected from a donor who was at risk for variant Creutzfeldt-Jakob disease (vCJD), were distributed.",1/29/2008,"01/29/2008",4/3/2013,"04/03/2013"
"Biologics",47114,"Terminated","LifeServe Blood Center","Des Moines","IA","US","Voluntary: Firm Initiated","Letter","Iowa, Michigan","B-0889-13","Class II","Red Blood Cells","LQ10869",,"1 unit","Blood products, collected from a donor who was at risk for variant Creutzfeldt-Jakob disease (vCJD), were distributed.",1/29/2008,"01/29/2008",4/3/2013,"04/03/2013"
"Biologics",47116,"Terminated","LifeServe Blood Center","Des Moines","IA","US","Voluntary: Firm Initiated","Telephone","Iowa","B-0818-13","Class II","Cryoprecipitated AHF","LF32631",,"1 unit","Blood product, which was not quarantined subsequent to receiving information regarding a post donation illness, was distributed.",1/11/2008,"01/11/2008",4/3/2013,"04/03/2013"
"Biologics",47124,"Terminated","Blood Systems, Inc.","Scottsdale","AZ","US","Voluntary: Firm Initiated","Letter","Arizona","B-2198-13","Class III","Red Blood Cells Leukocytes Reduced","103329106",,"1 unit","Blood product, prepared without the appropriate amount of RBC additive, was distributed. ",1/31/2008,"01/31/2008",9/4/2013,"09/04/2013"
"Biologics",47138,"Terminated","Community Blood Center Of Gtr KC","Kansas City","MO","US","Voluntary: Firm Initiated","Telephone","Kansas","B-0365-13","Class II","Platelets Pheresis Leukocytes Reduced","W045007915029 Part 1 ;W045007915029 Part 2",".","2 Units","Blood products, which were possibly contaminated with Propionibacterium species, were distributed.",1/2/2008,"01/02/2008",1/23/2013,"01/23/2013"
"Biologics",47139,"Terminated","Community Blood Center Of Gtr KC","Kansas City","MO","US","Voluntary: Firm Initiated","Telephone","Kansas; Missouri","B-0440-13","Class II","Platelets Pheresis Leukocytes Reduced","W045007912369A; W045007912369B",".","2 Units","Blood products, with positive bacterial detection testing, were distributed.",1/8/2008,"01/08/2008",2/6/2013,"02/06/2013"
"Biologics",47147,"Terminated","Blood Systems, Inc.","Scottsdale","AZ","US","Voluntary: Firm Initiated","Telephone","Arizona","B-2311-13","Class III","Red Blood Cells","103337722",,"1 unit","Red Cell product, lacking a proper visual inspection for clots, was distributed.",1/11/2008,"01/11/2008",11/6/2013,"11/06/2013"
"Biologics",47147,"Terminated","Blood Systems, Inc.","Scottsdale","AZ","US","Voluntary: Firm Initiated","Telephone","Arizona","B-2311-13","Class III","Red Blood Cells","103337722",,"1 unit","Red Cell product, lacking a proper visual inspection for clots, was distributed.",1/11/2008,"01/11/2008",11/6/2013,"11/06/2013"
"Biologics",47150,"Terminated","Lane Memorial Blood Bank","Eugene","OR","US","Voluntary: Firm Initiated","Letter","OR","B-1350-13","Class III","Red Blood Cells Leukocytes Reduced","W137507101405",".","1 unit","Blood product, collected from a donor with an elevated body temperature, was distributed.",1/7/2008,"01/07/2008",5/1/2013,"05/01/2013"
"Biologics",47151,"Terminated","New York Blood Center, Inc.","Westbury","NY","US","Voluntary: Firm Initiated","Telephone","New York","B-1563-13","Class II","Platelets Pheresis Leukocytes Reduced","7755526",,"1 unit","Blood products, which were possibly contaminated with peptostreptococcus, were distributed.",1/21/2008,"01/21/2008",7/3/2013,"07/03/2013"
"Biologics",47151,"Terminated","New York Blood Center, Inc.","Westbury","NY","US","Voluntary: Firm Initiated","Telephone","New York","B-1562-13","Class II","Platelets Pheresis Leukocytes Reduced Irradiated","7755526",,"1 unit","Blood products, which were possibly contaminated with peptostreptococcus, were distributed.",1/21/2008,"01/21/2008",7/3/2013,"07/03/2013"
"Biologics",47152,"Terminated","New York Blood Center, Inc.","New York","NY","US","Voluntary: Firm Initiated","Letter","New York","B-0724-13","Class III","Red Blood Cells Leukocytes Reduced","7764846;7764844",,"2 units ","Blood products, which were exposed to unacceptable temperature during storage, were distributed.",1/16/2008,"01/16/2008",3/13/2013,"03/13/2013"
"Biologics",47179,"Terminated","Community Blood Bank of Lancaster County Medical Society","Lincoln","NE","US","Voluntary: Firm Initiated","FAX","NE","B-0306-13","Class II","Red Blood Cells Leukocytes Reduced","3711224; 3705229",".","2 units","Blood products, which was collected from a donor who traveled to a malarial endemic area, were distributed.",1/21/2008,"01/21/2008",1/2/2013,"01/02/2013"
"Biologics",47185,"Terminated","Tri-counties Blood Bank","Phoenix","AZ","US","Voluntary: Firm Initiated","Telephone","CA","B-1875-13","Class II","Platelets Pheresis Leukocytes Reduced","LY26329; LY26329; LT54308; LT54308",,"4 units","Blood Products, which were contaminated with Corynebacterium species, were distributed. ",1/2/2008,"01/02/2008",8/7/2013,"08/07/2013"
"Food",47202,"Completed","WILDCAT CREEK POPCORN","PAYNE","OH","US","Voluntary: Firm Initiated","Telephone","Product was shipped to stores in IN & OH.","F-1129-2013","Class I","Wildcat Creek Farms Country Style Butter Flavored Popcorn Salt, 4.5oz glass shaker, UPC 7 28123 91010 4 & 40 oz pete container, UPC 7 28123 91009 8. 4633 Rd. 94, Payne, OH 45880","All product. 4.5 oz glass shaker, UPC 7 28123 91010 4 & 40 oz pete container, UPC 7 28123 91009 8 ",,"564/4.5 oz glass jars & 90/40 oz pete containers","Possible undeclared allergens. Milk, eggs, yellow #5, yellow #6 and red 40. ",2/22/2008,"02/22/2008",3/20/2013,"03/20/2013"
"Biologics",47268,"Terminated","Community Blood Centers of South Florida, Inc.","Lauderhill","FL","US","Voluntary: Firm Initiated","Telephone","Florida","B-1394-13","Class II","Platelets Pooled Leukocytes Reduced","2923709",".","1 unit","Blood product, whose integrity was compromised during component preparation (e.g., leaking at sterile connection site), was distributed.",12/27/2007,"12/27/2007",6/19/2013,"06/19/2013"
"Biologics",47269,"Terminated","Community Blood Centers of South Florida, Inc.","Lauderhill","FL","US","Voluntary: Firm Initiated","Telephone","New York","B-1630-13","Class II","Platelets Pheresis Leukocytes Reduced","2563975",,"1 unit","Blood product, labels applied to blood unit or product with incorrect and/or missing information, was distributed.",2/7/2008,"02/07/2008",7/3/2013,"07/03/2013"
"Biologics",47270,"Terminated","Community Blood Centers of South Florida, Inc.","Lauderhill","FL","US","Voluntary: Firm Initiated","Telephone","Florida","B-1396-13","Class II","Platelets Pheresis Leukocytes Reduced","2582623",".","1 unit","Blood products, which gave a positive result by the BacT system, were distributed.",1/8/2008,"01/08/2008",6/19/2013,"06/19/2013"
"Biologics",47270,"Terminated","Community Blood Centers of South Florida, Inc.","Lauderhill","FL","US","Voluntary: Firm Initiated","Telephone","Florida","B-1395-13","Class II","Platelets Pheresis Leukocytes Reduced Irradiated","2582623",".","1 unit","Blood products, which gave a positive result by the BacT system, were distributed.",1/8/2008,"01/08/2008",6/19/2013,"06/19/2013"
"Biologics",47271,"Terminated","Community Blood Centers of South Florida, Inc.","Lauderhill","FL","US","Voluntary: Firm Initiated","Telephone","Florida","B-1397-13","Class II","Platelets Pheresis Leukocytes Reduced","2554254(Part A); 2554254(Part B)",".","2 units","Blood products, with positive bacterial detection testing, were distributed.",1/14/2008,"01/14/2008",6/19/2013,"06/19/2013"
"Biologics",47272,"Terminated","Community Blood Centers of South Florida, Inc.","Lauderhill","FL","US","Voluntary: Firm Initiated","Telephone","New York","B-1398-13","Class II","Platelets Pheresis Leukocytes Reduced","2626418",".","1 unit","Blood product, with positive bacterial detection testing, was distributed.",2/2/2008,"02/02/2008",6/19/2013,"06/19/2013"
"Biologics",47295,"Terminated","LifeServe Blood Center","Des Moines","IA","US","Voluntary: Firm Initiated","Telephone","Iowa","B-0405-13","Class III","Platelets Pheresis Leukocytes Reduced","FW15035(Part A); FW15035(Part B)",,"2 Units","Blood products, for which the quality control testing was incomplete, were distributed.",2/7/2008,"02/07/2008",2/20/2013,"02/20/2013"
"Biologics",47297,"Terminated","American Red Cross Blood Services","Omaha","NE","US","Voluntary: Firm Initiated","Telephone","IA","B-1139-13","Class II","Red Blood Cells Leukocytes Reduced Irradiated","09KG49760; 09KG46759",".","2 units","Blood products, which were incompletely irradiated, were distributed.",1/16/2008,"01/16/2008",6/12/2013,"06/12/2013"
"Biologics",47306,"Terminated","New York Blood Center, Inc.","New York","NY","US","Voluntary: Firm Initiated","Telephone","New York","B-1348-13","Class III","Platelets Pheresis Leukocytes Reduced","7581341(Parts 1 and 2)",".","2 units","Blood products, which were possibly contaminated with Diptheroids, were distributed.",12/9/2007,"12/09/2007",5/1/2013,"05/01/2013"
"Biologics",47321,"Terminated","Lane Memorial Blood Bank","Eugene","OR","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Oregon, Florida","B-1099-13","Class II","Red Blood Cells Leukocytes Reduced","W137507102679; 7242381; 7239762.",,"3 components","Blood products, collected from a donor who reported travel to a malarial endemic area, were distributed",2/15/2008,"02/15/2008",5/8/2013,"05/08/2013"
"Biologics",47322,"Terminated","Community Blood Center of the Ozarks","Springfield","MO","US","Voluntary: Firm Initiated","Letter","Missouri","B-0310-13","Class II","Platelets","6868490",".","1 unit","Blood product, was not quarantined subsequent to receiving post donation illness information, was distributed.",2/7/2008,"02/07/2008",1/2/2013,"01/02/2013"
"Biologics",47332,"Terminated","BioLife Plasma Services L.P.","Van Nuys","CA","US","Voluntary: Firm Initiated","Letter","CA","B-2180-13","Class III","Source Plasma","07KINE8542;07KINE9460",".","2","Blood products, which were collected from a donor with a history of high risk behaviors, were distributed.",2/22/2008,"02/22/2008",9/18/2013,"09/18/2013"
"Biologics",47561,"Terminated","The Blood Alliance, Inc.","Jacksonville","FL","US","Voluntary: Firm Initiated","FAX","FL","B-1658-13","Class II","Red Blood Cells Leukocytes Reduced","5818588",".","1 unit","Blood products, recovered from an ineligible donor, was distributed. ",2/29/2008,"02/29/2008",7/10/2013,"07/10/2013"
"Biologics",47561,"Terminated","The Blood Alliance, Inc.","Jacksonville","FL","US","Voluntary: Firm Initiated","FAX","FL","B-1659-13","Class II","Fresh Frozen Plasma","5818588",".","1 unit","Blood products, recovered from an ineligible donor, was distributed. ",2/29/2008,"02/29/2008",7/10/2013,"07/10/2013"
"Biologics",47571,"Terminated","The American National Red Cross South Carolina Region","Columbia","SC","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","SC & CA","B-0973-13","Class II","Red Blood Cells Leukocytes Reduced","36FF29709",,"1 unit","Blood products, which were collected from a donor in which donor suitability was not adequately determined, were distributed.",1/17/2008,"01/17/2008",4/17/2013,"04/17/2013"
"Biologics",47571,"Terminated","The American National Red Cross South Carolina Region","Columbia","SC","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","SC & CA","B-0972-13","Class III","Blood and Blood Products for Reprocessing","36FF29709",,"1 unit","Blood products, which were collected from a donor in which donor suitability was not adequately determined, were distributed.",1/17/2008,"01/17/2008",4/17/2013,"04/17/2013"
"Biologics",47598,"Terminated","Blood Systems, Inc.","El Paso","TX","US","Voluntary: Firm Initiated","Telephone","TX","B-0533-13","Class III","Red Blood Cells (Apheresis) Leukocytes Reduced","115982544 (Part A) ;115982544 (Part B)",,"2 units","Blood products, where the blood collection of the products may have been compromised, were distributed. ",1/31/2008,"01/31/2008",2/20/2013,"02/20/2013"
"Biologics",47612,"Terminated","LifeServe Blood Center","Des Moines","IA","US","Voluntary: Firm Initiated","Letter","Iowa","B-0898-13","Class II","Red Blood Cells Leukocytes Reduced","LX71193",".","1 Unit","Blood product, collected from a donor possibly at increased risk for Creutzfeldt-Jakob Disease (CJD), was distributed.",2/25/2008,"02/25/2008",4/24/2013,"04/24/2013"
"Biologics",47620,"Terminated","Community Blood Center Of Gtr KC","Kansas City","MO","US","Voluntary: Firm Initiated","Telephone","Missouri and Indiana","B-0311-13","Class II","Fresh Frozen Plasma","W045007125365",".","1 unit","Blood product, collected from a donor who was at risk for variant Creutzfeldt-Jakob disease (vCJD), was distributed.",2/25/2008,"02/25/2008",1/2/2013,"01/02/2013"
"Biologics",47620,"Terminated","Community Blood Center Of Gtr KC","Kansas City","MO","US","Voluntary: Firm Initiated","Telephone","Missouri and Indiana","B-0312-13","Class II","Blood and Blood Products for Reprocessing","5116010",".","1 unit","Blood product, collected from a donor who was at risk for variant Creutzfeldt-Jakob disease (vCJD), was distributed.",2/25/2008,"02/25/2008",1/2/2013,"01/02/2013"
"Biologics",47621,"Terminated","American Red Cross Blood Services","Saint Louis","MO","US","Voluntary: Firm Initiated","Letter","MO","B-0250-13","Class II","Plasma Frozen","011FL56125",".","1 unit","Blood product, collected from a donor for whom donor suitability was not adequately determined, was distributed.",3/4/2008,"03/04/2008",2/6/2013,"02/06/2013"
"Biologics",47622,"Terminated","Tri-counties Blood Bank","Phoenix","AZ","US","Voluntary: Firm Initiated","Telephone","AZ","B-1895-13","Class II","Platelets Pheresis Leukocytes Reduced","GZ11666; GZ11666",".","2 units","Blood products, quality control and distribution of products which did not meet specifications, were distributed. . ",4/7/2008,"04/07/2008",8/14/2013,"08/14/2013"
"Biologics",47626,"Terminated","American National Red Cross (The)","Pomona","CA","US","Voluntary: Firm Initiated","Letter","CA","B-0052-14","Class II","Red Blood Cells Leukocytes Reduced Irradiated","06FC44187; 06FR90216",".","2 units","Blood products, not prepared in accordance with product specifications, were distributed.",2/6/2008,"02/06/2008",12/4/2013,"12/04/2013"
"Biologics",47629,"Terminated","Tri-counties Blood Bank","San Luis Obispo","CA","US","Voluntary: Firm Initiated","Telephone","CA","B-1876-13","Class III","Red Blood Cells Leukocytes Reduced","LT53144; LT53148; LT53135",,"3 units","Blood products, without any coolant in the shipping container, were distributed. ",1/29/2008,"01/29/2008",8/7/2013,"08/07/2013"
"Biologics",47684,"Terminated","American National Red Cross","Portland","OR","US","Voluntary: Firm Initiated","Letter","Washington, Oregon, and California.","B-0180-13","Class III","Blood and Blood Products for Reprocessing","21GV34559; 21KV00196; 21KV00328.",".","3 components","Blood products, collected from a donor whose suitability to donate was not adequately determined, were distributed.",2/21/2008,"02/21/2008",1/23/2013,"01/23/2013"
"Biologics",47684,"Terminated","American National Red Cross","Portland","OR","US","Voluntary: Firm Initiated","Letter","Washington, Oregon, and California.","B-0181-13","Class II","Red Blood Cells Leukocytes Reduced","21GV34559; 21KV00196; 21KV00328.",".","3 components","Blood products, collected from a donor whose suitability to donate was not adequately determined, were distributed.",2/21/2008,"02/21/2008",1/23/2013,"01/23/2013"
"Biologics",47702,"Terminated","American National Red Cross (The)","Salt Lake City","UT","US","Voluntary: Firm Initiated","Letter","UT","B-0099-14","Class II","Red Blood Cells, Leukocytes Reduced","20E65198",,"1 unit","Blood products, collected from a donor for whom donor suitability was not adequately determined, were distributed.",2/13/2008,"02/13/2008",12/18/2013,"12/18/2013"
"Biologics",47702,"Terminated","American National Red Cross (The)","Salt Lake City","UT","US","Voluntary: Firm Initiated","Letter","UT","B-0100-14","Class II","Plasma Frozen","20E65198",,"1 unit","Blood products, collected from a donor for whom donor suitability was not adequately determined, were distributed.",2/13/2008,"02/13/2008",12/18/2013,"12/18/2013"
"Biologics",47732,"Terminated","Community Blood Centers of South Florida, Inc.","Lauderhill","FL","US","Voluntary: Firm Initiated","Telephone","New York and Florida.","B-1822-13","Class II","Red Blood Cells","2648780",,"1","Blood products, collected from donors, whose suitability to donate was not adequately determined, were distributed.",3/20/2008,"03/20/2008",7/31/2013,"07/31/2013"
"Biologics",47732,"Terminated","Community Blood Centers of South Florida, Inc.","Lauderhill","FL","US","Voluntary: Firm Initiated","Telephone","New York and Florida.","B-1823-13","Class II","Platelets Pheresis Leukocytes Reduced Irradiated","2648780",,"1","Blood products, collected from donors, whose suitability to donate was not adequately determined, were distributed.",3/20/2008,"03/20/2008",7/31/2013,"07/31/2013"
"Biologics",47924,"Terminated","DCI Biologicals Orlando LLC","Jacksonville","FL","US","Voluntary: Firm Initiated","FAX","California","B-1100-13","Class II","Source Plasma","JK0182128",,"1","Blood products, collected from a donor who admitted to high risk behavior, were distributed.",2/27/2008,"02/27/2008",5/22/2013,"05/22/2013"
"Biologics",47926,"Terminated","Northwest Florida Blood Center, Inc.","Pensacola","FL","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","FL, AL","B-1655-13","Class II","Red Blood Cells Leukocytes Reduced","4360813; 4360796",".","2 units","Blood Products, in which Antibody Screen Testing was performed incorrectly, were distributed. ",1/16/2008,"01/16/2008",7/10/2013,"07/10/2013"
"Biologics",47926,"Terminated","Northwest Florida Blood Center, Inc.","Pensacola","FL","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","FL, AL","B-1656-13","Class II","Platelets Pheresis Leukocytes Reduced Irradiated","4668239A; 4668239B",".","2 units","Blood Products, in which Antibody Screen Testing was performed incorrectly, were distributed. ",1/16/2008,"01/16/2008",7/10/2013,"07/10/2013"
"Biologics",47926,"Terminated","Northwest Florida Blood Center, Inc.","Pensacola","FL","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","FL, AL","B-1657-13","Class II","Platelets Pheresis Leukocytes Reduced","4571232A; 4571232B; 4927022A; 4927022B; 4927021A; 4927021B.",".","6 units","Blood Products, in which Antibody Screen Testing was performed incorrectly, were distributed. ",1/16/2008,"01/16/2008",7/10/2013,"07/10/2013"
"Biologics",47926,"Terminated","Northwest Florida Blood Center, Inc.","Pensacola","FL","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","FL, AL","B-1653-13","Class II","Red Blood Cells Leukocytes Reduced Irradiated","5220672 ",".","1 unit","Blood Products, in which Antibody Screen Testing was performed incorrectly, were distributed. ",1/16/2008,"01/16/2008",7/10/2013,"07/10/2013"
"Biologics",47926,"Terminated","Northwest Florida Blood Center, Inc.","Pensacola","FL","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","FL, AL","B-1654-13","Class II","Red Blood Cells","4668249",".","1 unit","Blood Products, in which Antibody Screen Testing was performed incorrectly, were distributed. ",1/16/2008,"01/16/2008",7/10/2013,"07/10/2013"
"Biologics",47944,"Terminated","Community Blood Centers of South Florida, Inc.","Lauderhill","FL","US","Voluntary: Firm Initiated","Telephone","New York","B-1504-13","Class II","Platelets Pheresis Leukocytes Reduced","2626417",,"1","Blood products, possibly contaminated with bacteria, were distributed. ",2/4/2008,"02/04/2008",7/3/2013,"07/03/2013"
"Biologics",47946,"Terminated","Community Blood Centers of South Florida, Inc.","Lauderhill","FL","US","Voluntary: Firm Initiated","Telephone","New York","B-1934-13","Class II","Platelets Pooled Leukocytes Reduced","2929086",,"1","Blood product, manufactured from a unit of whole blood with incorrect volume was distributed.",3/25/2008,"03/25/2008",7/31/2013,"07/31/2013"
"Biologics",47978,"Terminated","LifeServe Blood Center","Sioux City","IA","US","Voluntary: Firm Initiated","Telephone","IA","B-0582-13","Class II","Red Blood Cells Leukocytes Reduced","2156722",".","1 unit","Blood component, processed from Whole Blood stored at room temperature for more than 8 hours after collection, was distributed.",3/24/2008,"03/24/2008",2/27/2013,"02/27/2013"
"Biologics",47980,"Terminated","Community Blood Bank of Lancaster County Medical Society","Lincoln","NE","US","Voluntary: Firm Initiated","E-Mail","Austria, IN","B-0556-13","Class II","Blood and Blood Products for Reprocessing","6073325",,"1 unit","Blood products, collected from a donor who was at risk for variant Creutzfeldt-Jakob disease (vCJD), was distributed.",2/25/2008,"02/25/2008",2/20/2013,"02/20/2013"
"Biologics",47982,"Terminated","Community Blood Center Of Gtr KC","Kansas City","MO","US","Voluntary: Firm Initiated","Letter","California","B-0303-13","Class III","Blood and Blood Products for Reprocessing","W045006066878",".","1 unit","Blood product, collected from a donor who was at risk for variant Creutzfeldt-Jakob disease (vCJD), was distributed.",2/12/2008,"02/12/2008",1/2/2013,"01/02/2013"
"Biologics",47983,"Terminated","Community Blood Center Of Gtr KC","Kansas City","MO","US","Voluntary: Firm Initiated","FAX","KS, MO, IN, Austria","B-0537-13","Class II","Fresh Frozen Plasma","0301805; 0328053; 1336389; 0429177; W045004001160",,"5 units","Blood products, collected from a donor who was in close contact with an individual diagnosed with viral hepatitis, were distributed.",2/28/2008,"02/28/2008",2/20/2013,"02/20/2013"
"Biologics",47983,"Terminated","Community Blood Center Of Gtr KC","Kansas City","MO","US","Voluntary: Firm Initiated","FAX","KS, MO, IN, Austria","B-0536-13","Class II","Platelets","0301805; 0429177",,"2 units","Blood products, collected from a donor who was in close contact with an individual diagnosed with viral hepatitis, were distributed.",2/28/2008,"02/28/2008",2/20/2013,"02/20/2013"
"Biologics",47983,"Terminated","Community Blood Center Of Gtr KC","Kansas City","MO","US","Voluntary: Firm Initiated","FAX","KS, MO, IN, Austria","B-0534-13","Class II","Red Blood Cells","0301805; 0429177",,"2 units","Blood products, collected from a donor who was in close contact with an individual diagnosed with viral hepatitis, were distributed.",2/28/2008,"02/28/2008",2/20/2013,"02/20/2013"
"Biologics",47983,"Terminated","Community Blood Center Of Gtr KC","Kansas City","MO","US","Voluntary: Firm Initiated","FAX","KS, MO, IN, Austria","B-0535-13","Class II","Red Blood Cells Leukocytes Reduced","0328053; 0357685; 1336389; W045004001160; W045005025891; W045006037539",,"6 units","Blood products, collected from a donor who was in close contact with an individual diagnosed with viral hepatitis, were distributed.",2/28/2008,"02/28/2008",2/20/2013,"02/20/2013"
"Biologics",47983,"Terminated","Community Blood Center Of Gtr KC","Kansas City","MO","US","Voluntary: Firm Initiated","FAX","KS, MO, IN, Austria","B-0537-13","Class II","Fresh Frozen Plasma","0301805; 0328053; 1336389; 0429177; W045004001160",".","5 units","Blood products, collected from a donor who was in close contact with an individual diagnosed with viral hepatitis, were distributed.",2/28/2008,"02/28/2008",4/24/2013,"04/24/2013"
"Biologics",47983,"Terminated","Community Blood Center Of Gtr KC","Kansas City","MO","US","Voluntary: Firm Initiated","FAX","KS, MO, IN, Austria","B-0535-13","Class II","Red Blood Cells Leukocytes Reduced","0328053; 0357685; 1336389; W045004001160; W045005025891; W045006037539",".","6 units","Blood products, collected from a donor who was in close contact with an individual diagnosed with viral hepatitis, were distributed.",2/28/2008,"02/28/2008",4/24/2013,"04/24/2013"
"Biologics",47983,"Terminated","Community Blood Center Of Gtr KC","Kansas City","MO","US","Voluntary: Firm Initiated","FAX","KS, MO, IN, Austria","B-0534-13","Class II","Red Blood Cells","0301805; 0429177",".","2 units","Blood products, collected from a donor who was in close contact with an individual diagnosed with viral hepatitis, were distributed.",2/28/2008,"02/28/2008",4/24/2013,"04/24/2013"
"Biologics",47983,"Terminated","Community Blood Center Of Gtr KC","Kansas City","MO","US","Voluntary: Firm Initiated","FAX","KS, MO, IN, Austria","B-0536-13","Class II","Platelets","0301805; 0429177",".","2 units","Blood products, collected from a donor who was in close contact with an individual diagnosed with viral hepatitis, were distributed.",2/28/2008,"02/28/2008",4/24/2013,"04/24/2013"
"Biologics",47985,"Terminated","Community Blood Center Of Gtr KC","Kansas City","MO","US","Voluntary: Firm Initiated","FAX","Missouri; Kansas","B-0431-13","Class II","Red Blood Cells Leukocytes Reduced Irradiated","W045007010581",".","1 Unit","Blood products, collected from a donor who was in close contact with an individual diagnosed with viral hepatitis, were distributed.",3/28/2008,"03/28/2008",2/6/2013,"02/06/2013"
"Biologics",47985,"Terminated","Community Blood Center Of Gtr KC","Kansas City","MO","US","Voluntary: Firm Initiated","FAX","Missouri; Kansas","B-0432-13","Class II","Red Blood Cells (Apheresis) Leukocytes Reduced Irradiated","W045007001094;W045007001094",".","2 Units","Blood products, collected from a donor who was in close contact with an individual diagnosed with viral hepatitis, were distributed.",3/28/2008,"03/28/2008",2/6/2013,"02/06/2013"
"Biologics",47985,"Terminated","Community Blood Center Of Gtr KC","Kansas City","MO","US","Voluntary: Firm Initiated","FAX","Missouri; Kansas","B-0433-13","Class II","Red Blood Cells Leukocytes Reduced","W045007142019",".","1 Unit","Blood products, collected from a donor who was in close contact with an individual diagnosed with viral hepatitis, were distributed.",3/28/2008,"03/28/2008",2/6/2013,"02/06/2013"
"Biologics",47985,"Terminated","Community Blood Center Of Gtr KC","Kansas City","MO","US","Voluntary: Firm Initiated","FAX","Missouri; Kansas","B-0434-13","Class II","Fresh Frozen Plasma","W045007010581",".","1 Unit","Blood products, collected from a donor who was in close contact with an individual diagnosed with viral hepatitis, were distributed.",3/28/2008,"03/28/2008",2/6/2013,"02/06/2013"
"Biologics",47985,"Terminated","Community Blood Center Of Gtr KC","Kansas City","MO","US","Voluntary: Firm Initiated","FAX","Missouri; Kansas","B-0430-13","Class II","Red Blood Cells (Apheresis) Leukocytes Reduced","W045006108058;W045006108058",".","2 Units","Blood products, collected from a donor who was in close contact with an individual diagnosed with viral hepatitis, were distributed.",3/28/2008,"03/28/2008",2/6/2013,"02/06/2013"
"Biologics",47987,"Terminated","Community Blood Center Of Gtr KC","Kansas City","MO","US","Voluntary: Firm Initiated","Telephone","Missouri","B-0367-13","Class II","Red Blood Cells (Apheresis) Leukocytes Reduced","W045008007317 Part A ;W045008007317 Part B",".","2 Units","Blood products, which failed to meet the minimum specification for product volume, were distributed",3/5/2008,"03/05/2008",1/23/2013,"01/23/2013"
"Biologics",47998,"Terminated","American National Red Cross (The)","Tucson","AZ","US","Voluntary: Firm Initiated","Letter","Arizona, California","B-1970-13","Class II","Red Blood Cells Leukocytes Reduced","007FJ96470; 007FJ96486; 007FQ47632; 007FY69895; 007GT00703",,"5 units","Blood products, collected from a donor whose suitability to donate were not adequately determined, were distributed.",5/6/2008,"05/06/2008",8/7/2013,"08/07/2013"
"Biologics",47999,"Terminated","Csl Plasma Inc","Tempe","AZ","US","Voluntary: Firm Initiated","FAX","IL, Switzerland, Germany","B-1558-13","Class III","Source Plasma","4270122230; 4270106949; 4270101308; 4270099113; 4270098694",,"5 units","Blood products, collected from a donor, whose suitability to donate were not adequately determined, were distributed. ",3/4/2008,"03/04/2008",7/3/2013,"07/03/2013"
"Biologics",48000,"Terminated","Csl Plasma Inc","Tempe","AZ","US","Voluntary: Firm Initiated","FAX","Germany","B-1559-13","Class III","Source Plasma","4270111724; 4270109791; 4270108726; 4270107852",,"4 units","Blood products, collected from a donor, whose suitability to donate were not adequately determined, were distributed. ",2/28/2008,"02/28/2008",7/3/2013,"07/03/2013"
"Biologics",48041,"Terminated","American National Red Cross","Portland","OR","US","Voluntary: Firm Initiated","Letter","California and Washington.","B-1277-13","Class II","Red Blood Cells Leukocytes Reduced","21LL23077.",".","1 component","Blood products, collected from a donor who was in close contact with an individual diagnosed as a hepatitis B carrier, were distributed..",3/13/2008,"03/13/2008",6/12/2013,"06/12/2013"
"Biologics",48041,"Terminated","American National Red Cross","Portland","OR","US","Voluntary: Firm Initiated","Letter","California and Washington.","B-1278-13","Class II","Cryoprecipitated AHF","21LL23077.",".","1 component","Blood products, collected from a donor who was in close contact with an individual diagnosed as a hepatitis B carrier, were distributed..",3/13/2008,"03/13/2008",6/12/2013,"06/12/2013"
"Biologics",48041,"Terminated","American National Red Cross","Portland","OR","US","Voluntary: Firm Initiated","Letter","California and Washington.","B-1276-13","Class II","Blood and Blood Products for Reprocessing","21LL23077.",".","1 component","Blood products, collected from a donor who was in close contact with an individual diagnosed as a hepatitis B carrier, were distributed..",3/13/2008,"03/13/2008",6/12/2013,"06/12/2013"
"Biologics",48058,"Terminated","DCI Biologicals Orlando LLC","Orlando","FL","US","Voluntary: Firm Initiated","FAX","Pennsylvania","B-1101-13","Class III","Source Plasma","OL0107985; OL0108176; OL0108514; OL0108652; OL0109051 ",,"5","Blood products, collected from a donor whose suitability to donate was not adequately determined, were distributed.",2/7/2008,"02/07/2008",5/22/2013,"05/22/2013"
"Biologics",48059,"Terminated","American National Red Cross (The)","West Henrietta","NY","US","Voluntary: Firm Initiated","Letter","NY","B-1326-13","Class II","Red Blood Cells Leukocytes Reduced","01GE68894; 01GE67226; 01GE68077; 01GE63062",".","4 ","Blood products, collected from a donor who reported travel to a malarial endemic area, were distributed. ",2/5/2008,"02/05/2008",6/5/2013,"06/05/2013"
"Biologics",48227,"Terminated","Octapharma Plasma Inc","Van Nuys","CA","US","Voluntary: Firm Initiated","Letter","Switzerland","B-2252-13","Class III","Source Plasma","0460024213",,"1 unit","Blood product, in which donor donated without an acceptable arm check, was distributed. ",3/13/2008,"03/13/2008",9/25/2013,"09/25/2013"
"Biologics",48234,"Terminated","American National Red Cross (The)","West Henrietta","NY","US","Voluntary: Firm Initiated","Letter","NY","B-1650-13","Class II","Red Blood Cells Leukocytes Reduced","01KM49645",".","1 unit","Blood products, collected from a donor in which donor suitability was not adequately determined, were distributed.",3/25/2008,"03/25/2008",7/10/2013,"07/10/2013"
"Biologics",48234,"Terminated","American National Red Cross (The)","West Henrietta","NY","US","Voluntary: Firm Initiated","Letter","NY","B-1651-13","Class II","Plasma Frozen","01KM49645",".","1 unit","Blood products, collected from a donor in which donor suitability was not adequately determined, were distributed.",3/25/2008,"03/25/2008",7/10/2013,"07/10/2013"
"Biologics",48234,"Terminated","American National Red Cross (The)","West Henrietta","NY","US","Voluntary: Firm Initiated","Letter","NY","B-1652-13","Class II","Platelets Leukocytes Reduced","01KM49645",".","1 unit","Blood products, collected from a donor in which donor suitability was not adequately determined, were distributed.",3/25/2008,"03/25/2008",7/10/2013,"07/10/2013"
"Biologics",48236,"Terminated","American Red Cross Blood Services","Saint Louis","MO","US","Voluntary: Firm Initiated","Telephone","OK, TX","B-0605-13","Class III","Blood and Blood Products for Reprocessing","011KJ12464",".","1 unit","Blood products, collected from a donor whose suitability to donate was not adequately determined, were distributed.",4/8/2008,"04/08/2008",2/27/2013,"02/27/2013"
"Biologics",48236,"Terminated","American Red Cross Blood Services","Saint Louis","MO","US","Voluntary: Firm Initiated","Telephone","OK, TX","B-0606-13","Class II","Red Blood Cells Leukocytes Reduced","011KJ12464",".","1 unit","Blood products, collected from a donor whose suitability to donate was not adequately determined, were distributed.",4/8/2008,"04/08/2008",2/27/2013,"02/27/2013"
"Biologics",48241,"Terminated","DCI Biologicals Little Rock LLC","Little Rock","AR","US","Voluntary: Firm Initiated","FAX","United Kingdom","B-1307-13","Class II","Source Plasma","LR0215098, LR0222997, LR0224240, LR0224594, LR0225469, LR0225667, LR0230265, LR0234059, LR0234404, LR0234950, LR0235270, LR0235967, LR0236282, LR0236833, LR0237158, LR0237695, LR0237950, LR0239090, LR0239505, LR0240004, LR0240475, LR0241134, LR0241575, LR0242181, LR0242431, LR0243068, LR0243485, LR0244000, LR0252971, LR0253257, LR0253927, LR0254208, LR0254915, LR0255241, LR0256141, LR0256299, LR0256898, LR0257253, LR0257828, LR0258242, LR0258846, LR0259231, LR0259832, LR0260202, LR0260728, LR0261231, LR0261687, LR0262202, LR0262634, LR0263137, LR0263649, LR0264189, LR0264762, LR0265230, LR0265636, LR0266344, LR0266621, LR0271856, LR0274376, LR0274651",".","60 units","Blood products, collected from a donor who was at risk for variant Creutzfeldt-Jakob Disease (vCJD), were distributed.",3/24/2008,"03/24/2008",5/1/2013,"05/01/2013"
"Biologics",48246,"Terminated","The American National Red Cross South Carolina Region","Columbia","SC","US","Voluntary: Firm Initiated","Telephone","SC","B-1711-13","Class II","Red Blood Cells Leukocytes Reduced","36L92853",".","1","Blood products, collected from a donor in whom donor suitability was not adequately determined, were distributed.",3/19/2008,"03/19/2008",7/17/2013,"07/17/2013"
"Biologics",48246,"Terminated","The American National Red Cross South Carolina Region","Columbia","SC","US","Voluntary: Firm Initiated","Telephone","SC","B-1712-13","Class II","Plasma Frozen","36L92853",".","1","Blood products, collected from a donor in whom donor suitability was not adequately determined, were distributed.",3/19/2008,"03/19/2008",7/17/2013,"07/17/2013"
"Biologics",48263,"Terminated","Blood Systems, Inc.","El Paso","TX","US","Voluntary: Firm Initiated","Telephone","NM","B-0538-13","Class II","Platelets Pheresis Leukocytes Reduced","116000858;116000858;116000858",,"3 units","Blood Products, which were contaminated with Corynebacterium species, were distributed.",3/30/2008,"03/30/2008",2/20/2013,"02/20/2013"
"Biologics",48264,"Terminated","Blood Systems, Inc.","El Paso","TX","US","Voluntary: Firm Initiated","Telephone","TX","B-0261-13","Class III","Platelets Pheresis Leukocytes Reduced Irradiated","115998840 ",".","1 unit","Blood products, which were possibly contaminated, were distributed.",3/27/2008,"03/27/2008",2/6/2013,"02/06/2013"
"Biologics",48264,"Terminated","Blood Systems, Inc.","El Paso","TX","US","Voluntary: Firm Initiated","Telephone","TX","B-0260-13","Class III","Platelets Pheresis Leukocytes Reduced","115998840 ",".","1 unit","Blood products, which were possibly contaminated, were distributed.",3/27/2008,"03/27/2008",2/6/2013,"02/06/2013"
"Biologics",48271,"Terminated","Florida's Blood Centers, Inc.","Orlando","FL","US","Voluntary: Firm Initiated",,"FL","B-1288-13","Class II","Platelets Pheresis Leukocytes Reduced","9866577- Part 2",".","1 unit","Blood product, labeled with incorrect expiration date and product code, was distributed.",9/13/2007,"09/13/2007",7/10/2013,"07/10/2013"
"Biologics",48282,"Terminated","Community Blood Center Of Gtr KC","Kansas City","MO","US","Voluntary: Firm Initiated","Telephone","Missouri","B-0309-13","Class II","Fresh Frozen Plasma","W045007145917",".","1 unit","Donor Screening/Donor gave history which warranted deferral or follow up and was not deferred or follow up questions were not asked.",4/4/2008,"04/04/2008",1/2/2013,"01/02/2013"
"Biologics",48287,"Terminated","American National Red Cross (The)","Tucson","AZ","US","Voluntary: Firm Initiated","Letter","AZ","B-0054-14","Class II","Red Blood Cells Leukocytes Reduced","07FY73202; 07FY73208",".","2 units","Blood products, possibly contaminated with air, were distributed.",4/23/2008,"04/23/2008",12/4/2013,"12/04/2013"
"Biologics",48287,"Terminated","American National Red Cross (The)","Tucson","AZ","US","Voluntary: Firm Initiated","Letter","AZ","B-0053-14","Class II","Red Blood Cells Leukocytes Reduced Irradiated","07FR32612",".","1 unit","Blood products, possibly contaminated with air, were distributed.",4/23/2008,"04/23/2008",12/4/2013,"12/04/2013"
"Biologics",48287,"Terminated","American National Red Cross (The)","Tucson","AZ","US","Voluntary: Firm Initiated","Letter","AZ","B-0055-14","Class II","Plasma Frozen","07FY73199",".","1 unit","Blood products, possibly contaminated with air, were distributed.",4/23/2008,"04/23/2008",12/4/2013,"12/04/2013"
"Biologics",48296,"Terminated","Talecris Plasma Resources Inc Dba International Bioresources","Research Triangle Park","NC","US","Voluntary: Firm Initiated","FAX","North Carolina","B-1666-13","Class III","Source Plasma","368092877",".","1 unit","Blood product, collected from a donor whose arm inspection was not documented, was distributed.",4/24/2008,"04/24/2008",7/24/2013,"07/24/2013"
"Biologics",48297,"Terminated","Talecris Plasma Resources Inc Dba International Bioresources","Research Triangle Park","NC","US","Voluntary: Firm Initiated","FAX","North Carolina","B-1700-13","Class III","Source Plasma","368095570",".","1 unit","Blood product, collected from a donor for whom donor suitability was not adequately determined, was distributed.",4/9/2008,"04/09/2008",7/24/2013,"07/24/2013"
"Biologics",48299,"Terminated","Csl Plasma Inc","Tempe","AZ","US","Voluntary: Firm Initiated","FAX","IL, Switzerland","B-1796-13","Class II","Source Plasma","4270133819; 4270132571; 4270131033; 4270129823; 4270128160; 4270127401; 4270126368",".","7 units","Blood products, collected from a donor whose annual physical examination was inadequately documented, were distributed. ",3/24/2008,"03/24/2008",7/24/2013,"07/24/2013"
"Biologics",48309,"Terminated","LifeServe Blood Center","Des Moines","IA","US","Voluntary: Firm Initiated","E-Mail","Switzerland","B-0897-13","Class II","Blood and Blood Products for Reprocessing","LX73700",".","1 Unit","Blood product, collected from a donor considered to be at increased risk for variant Creutzfeldt-Jakob Disease (vCJD), was distributed. ",4/23/2008,"04/23/2008",4/24/2013,"04/24/2013"
"Biologics",48336,"Terminated","Florida Blood Services, Inc.","Pensacola","FL","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","AL","B-1289-13","Class II","Platelets Pheresis Leukocytes Reduced","4927543A",".","1 unit","Blood product, possibly contaminated with air, was distributed.",4/17/2008,"04/17/2008",7/10/2013,"07/10/2013"
"Biologics",48364,"Terminated","American National Red Cross (The)","Portland","OR","US","Voluntary: Firm Initiated","Letter","OR, PA, and CA","B-2501-13","Class II","Cryoprecipitate AHF","21KS72981",,"1 unit","Blood products, collected from a previously deferred donor, were distributed.",4/15/2008,"04/15/2008",11/27/2013,"11/27/2013"
"Biologics",48364,"Terminated","American National Red Cross (The)","Portland","OR","US","Voluntary: Firm Initiated","Letter","OR, PA, and CA","B-2499-13","Class II","Blood and Blood Products for Reprocessing","21KS72981",,"1 unit","Blood products, collected from a previously deferred donor, were distributed.",4/15/2008,"04/15/2008",11/27/2013,"11/27/2013"
"Biologics",48364,"Terminated","American National Red Cross (The)","Portland","OR","US","Voluntary: Firm Initiated","Letter","OR, PA, and CA","B-2500-13","Class II","Red Blood Cells Leukocytes Reduced","21KS72981",,"1 unit","Blood products, collected from a previously deferred donor, were distributed.",4/15/2008,"04/15/2008",11/27/2013,"11/27/2013"
"Biologics",48373,"Terminated","BioLife Plasma Services L.P.","Cedar Rapids","IA","US","Voluntary: Firm Initiated","FAX","Austria","B-2296-13","Class II","Source Plasma","07CIAM3734, 07CIAM3038, 07CIAM2132",,"3 units","Blood products, collected from a donor with a history of hepatitis and fatty liver disease, were distributed.",4/29/2008,"04/29/2008",9/25/2013,"09/25/2013"
"Biologics",48379,"Terminated","American National Red Cross (The)","Boise","ID","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","CA","B-1174-13","Class III","Blood and Blood Products for Reprocessing","20LQ15418",,"1 unit","Blood products, collected from a donor whose suitability to donate was not adequately determined, were distributed.",4/2/2008,"04/02/2008",5/22/2013,"05/22/2013"
"Biologics",48379,"Terminated","American National Red Cross (The)","Boise","ID","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","CA","B-1175-13","Class II","Red Blood Cells Leukocytes Reduced","20LQ15418",,"1 unit","Blood products, collected from a donor whose suitability to donate was not adequately determined, were distributed.",4/2/2008,"04/02/2008",5/22/2013,"05/22/2013"
"Biologics",48385,"Terminated","American National Red Cross (The)","Boise","ID","US","Voluntary: Firm Initiated","FAX","Idaho and California.","B-0045-14","Class II","Red Blood Cells Leukocytes Reduced","20LZ33722.",,"1 component","Blood products, which were collected from a donor in which donor suitability was not adequately determined, were distributed.",4/3/2008,"04/03/2008",12/18/2013,"12/18/2013"
"Biologics",48385,"Terminated","American National Red Cross (The)","Boise","ID","US","Voluntary: Firm Initiated","FAX","Idaho and California.","B-0044-14","Class III","Blood and Blood Products for Reprocessing","20LZ33722.",,"1 component","Blood products, which were collected from a donor in which donor suitability was not adequately determined, were distributed.",4/3/2008,"04/03/2008",12/18/2013,"12/18/2013"
"Biologics",48388,"Terminated","American National Red Cross (The)","Pomona","CA","US","Voluntary: Firm Initiated","Telephone","California, Arizona, Washington DC","B-2068-13","Class II","Red Blood Cells Leukocytes Reduced Irradiated","06FM42146, 06FM42698, ",".","2 units","Blood products, collected from donors in which donor suitability was not adequately determined, were distributed.",4/2/2008,"04/02/2008",8/14/2013,"08/14/2013"
"Biologics",48388,"Terminated","American National Red Cross (The)","Pomona","CA","US","Voluntary: Firm Initiated","Telephone","California, Arizona, Washington DC","B-2069-13","Class II","Red Blood Cells Leukocytes Reduced","06LC12397, 06LK96510, 06LQ82947, 06FP66382, 06GS22086, 06GV57858, 06LQ83398, 06GW37271, 06GF50169, 06GE22291, 06GS23145, 06LF92077, 06GF51447, 084FT13509, 084J 21960, 084KM77737, 084T48723, 084T49156, 07FC33547, 07GT00491, 07GJ28906, 07FJ97037, 07FY72624,06FT00807, 06LE43292, 06FT01385, 06FE13059, 06FM42146, 084K00268, 07FC33546",".","30","Blood products, collected from donors in which donor suitability was not adequately determined, were distributed..",4/2/2008,"04/02/2008",8/14/2013,"08/14/2013"
"Biologics",48388,"Terminated","American National Red Cross (The)","Pomona","CA","US","Voluntary: Firm Initiated","Telephone","California, Arizona, Washington DC","B-2074-13","Class II","Recovered Plasma ","06KG50494, 06KR54131, 06KR54178,06KR54290, 06GS22086, 06LQ83398,084T48723, 084T49156, 07GT00491,07GJ28906, ",".","10 units","Blood products, collected from donors in which donor suitability was not adequately determined, were distributed.",4/2/2008,"04/02/2008",8/14/2013,"08/14/2013"
"Biologics",48388,"Terminated","American National Red Cross (The)","Pomona","CA","US","Voluntary: Firm Initiated","Telephone","California, Arizona, Washington DC","B-2071-13","Class II","Platelets Pheresis Leukocytes Reduced Irradiated","06KR54131, 06KR54178, 06KR54290,06KG50494, 06KR54131, 06KR54178, 06KR54290, ",".","7 units","Blood products, collected from donors in which donor suitability was not adequately determined, were distributed.",4/2/2008,"04/02/2008",8/14/2013,"08/14/2013"
"Biologics",48388,"Terminated","American National Red Cross (The)","Pomona","CA","US","Voluntary: Firm Initiated","Telephone","California, Arizona, Washington DC","B-2072-13","Class II"," Plasma Cryoprecipitate Poor Reduced","06GW37271,06GS23145, 084K00351, ",".","3 units","Blood products, collected from donors in which donor suitability was not adequately determined, were distributed.",4/2/2008,"04/02/2008",8/14/2013,"08/14/2013"
"Biologics",48388,"Terminated","American National Red Cross (The)","Pomona","CA","US","Voluntary: Firm Initiated","Telephone","California, Arizona, Washington DC","B-2070-13","Class II","Cryoprecipitated AHF","06FS23078, 06FP66382, 06GW37271, 06GS23145, ",".","4 units","Blood products, collected from donors in which donor suitability was not adequately determined, were distributed.",4/2/2008,"04/02/2008",8/14/2013,"08/14/2013"
"Biologics",48388,"Terminated","American National Red Cross (The)","Pomona","CA","US","Voluntary: Firm Initiated","Telephone","California, Arizona, Washington DC","B-2067-13","Class II","Red Blood Cells (Apheresis) ","06FS23078 , 06LF90461, ",".","2 units","Blood products, collected from donors in which donor suitability was not adequately determined, were distributed.",4/2/2008,"04/02/2008",8/14/2013,"08/14/2013"
"Biologics",48388,"Terminated","American National Red Cross (The)","Pomona","CA","US","Voluntary: Firm Initiated","Telephone","California, Arizona, Washington DC","B-2073-13","Class II"," Plasma Frozen within 24 hours"," 06LK96510, 06LE43292, 06GV57858, 06GF50169, 06FE13059, 084FT13509, 07FY72624, 06LQ82947,06FM42146,06GE22291, 084J 21960, 084KM77737, 084K00268, 07FC33546,07FJ97037, ",".","15","Blood products, collected from donors in which donor suitability was not adequately determined, were distributed.",4/2/2008,"04/02/2008",8/14/2013,"08/14/2013"
"Biologics",48412,"Terminated","Csl Plasma Inc","Tempe","AZ","US","Voluntary: Firm Initiated","Letter","Illinois , Germany and Switzerland","B-2179-13","Class II","Source Plasma","4270132248;4270130600;4270128882;4270127841; 4270126989;4270126289;4270125004;4270124398 ;4270119210;4270118499;4270117695",,"11 units","Blood products, collected from a donor whose scheduled physical examination was incomplete, were distributed.",4/1/2008,"04/01/2008",9/25/2013,"09/25/2013"
"Biologics",48481,"Terminated","American National Red Cross (The)","Salt Lake City","UT","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","UT, CA","B-1158-13","Class II","Red Blood Cells Leukocytes Reduced","20LP81716",".","1 unit","Blood products, collected in a manner that may have compromised sterility, were distributed.",2/13/2008,"02/13/2008",5/29/2013,"05/29/2013"
"Biologics",48483,"Terminated","Community Blood Centers of South Florida, Inc.","Lauderhill","FL","US","Voluntary: Firm Initiated","Telephone","Florida","B-1631-13","Class II","Red Blood Cells","2545079",".","1 unit","Blood product, identified unsuitable due to a donor screening deviation, was distributed.",3/20/2008,"03/20/2008",7/17/2013,"07/17/2013"
"Biologics",48494,"Terminated","Community Blood Center of the Ozarks","Springfield","MO","US","Voluntary: Firm Initiated","Letter","MO","B-1537-13","Class III","Red Blood Cells Leukocytes Reduced","6865366; 6865369",,"2 units","Blood products, stored at unacceptable storage temperatures, were distributed.",4/21/2008,"04/21/2008",8/21/2013,"08/21/2013"
"Biologics",48494,"Terminated","Community Blood Center of the Ozarks","Springfield","MO","US","Voluntary: Firm Initiated","Letter","MO","B-1536-13","Class III","Red Blood Cells","6856986; 6860461; 6861215; 6865547; 6854661; 6842690; 6857040; 6856333; 6862806; 6862820; 6862823; 6862826; 6864736; 6857712; 6857728; 6857683; 6857716; 6857973; 6868355; 6864305; 6864360; 6860658; 6865286; 6865301; 6864300; 6868319; 6868328",,"27 units","Blood products, stored at unacceptable storage temperatures, were distributed.",4/21/2008,"04/21/2008",8/21/2013,"08/21/2013"
"Biologics",48497,"Terminated","American National Red Cross","Portland","OR","US","Voluntary: Firm Initiated","Letter","California and Oregon.","B-0813-13","Class III","Blood and Blood Products for Reprocessing","21LV32945.",,"1 component","Blood products, collected from a donor in whom donor suitability was not adequately determined, were distributed.",3/22/2008,"03/22/2008",4/3/2013,"04/03/2013"
"Biologics",48497,"Terminated","American National Red Cross","Portland","OR","US","Voluntary: Firm Initiated","Letter","California and Oregon.","B-0814-13","Class II","Red Blood Cells Leukocytes Reduced","21LV32945",,"1 component","Blood products, collected from a donor in whom donor suitability was not adequately determined, were distributed.",3/22/2008,"03/22/2008",4/3/2013,"04/03/2013"
"Biologics",48508,"Terminated","Blood Systems, Inc.","Scottsdale","AZ","US","Voluntary: Firm Initiated","E-Mail","AZ","B-2461-13","Class II","Red Blood Cells (Apheresis) Leukocytes Reduced","103412622",,"1 unit","Blood product, labeled as leukoreduced was not tested to verify the White Blood Cell count, was distributed.",4/11/2008,"04/11/2008",11/27/2013,"11/27/2013"
"Biologics",48509,"Terminated","Community Blood Center of the Ozarks","Springfield","MO","US","Voluntary: Firm Initiated","Letter","North Carolina; Austria","B-1094-13","Class III","Blood and Blood Products for Reprocessing","6864613",,"1","Blood products, collected from a donor who was previously deferred for positive HIV test results, were distributed. ",5/12/2008,"05/12/2008",5/22/2013,"05/22/2013"
"Biologics",48509,"Terminated","Community Blood Center of the Ozarks","Springfield","MO","US","Voluntary: Firm Initiated","Letter","North Carolina; Austria","B-1095-13","Class II","Red Blood Cells Leukocytes Reduced","6864613",,"1 ","Blood products, collected from a donor who was previously deferred for positive HIV test results, were distributed. ",5/12/2008,"05/12/2008",5/22/2013,"05/22/2013"
"Biologics",48521,"Terminated","Blood Bank of San Bernardino and Riverside Counties","San Bernardino","CA","US","Voluntary: Firm Initiated","Telephone","California","B-2342-13","Class II","Red Blood Cells Leukocytes Reduced","GC46798; GP89735; GP70416; GP42867; GP02047; GN88510; GN70079;GN37152;GN17495; GN19682; GN10205; GM97295; GM74549; GM59314; GM38976",".","15 units","Blood products, collected from donors whose suitability to donate was not adequately determined, were distributed.",5/21/2008,"05/21/2008",9/18/2013,"09/18/2013"
"Biologics",48521,"Terminated","Blood Bank of San Bernardino and Riverside Counties","San Bernardino","CA","US","Voluntary: Firm Initiated","Telephone","California","B-2343-13","Class II","Plasma","GC46798; GP42867; GN37152",".","3 units","Blood products, collected from donors whose suitability to donate was not adequately determined, were distributed.",5/21/2008,"05/21/2008",9/18/2013,"09/18/2013"
"Biologics",48521,"Terminated","Blood Bank of San Bernardino and Riverside Counties","San Bernardino","CA","US","Voluntary: Firm Initiated","Telephone","California","B-2341-13","Class III","Blood and Blood Products for Reprocessing","GP89735; GP70416; GN17495; GP02047; GN88510; GN70079; GN10205; GM97295; GM74549; GM38976",".","10 units","Blood products, collected from donors whose suitability to donate was not adequately determined, were distributed.",5/21/2008,"05/21/2008",9/18/2013,"09/18/2013"
"Biologics",48525,"Terminated","BioLife Plasma Services L.P.","Van Nuys","CA","US","Voluntary: Firm Initiated","Letter","CA","B-2065-13","Class II","Source Plasma","07SWIC5381",".","1","Blood product, which was not quarantined subsequent to receiving information regarding a post donation information, was distributed.",5/22/2008,"05/22/2008",8/14/2013,"08/14/2013"
"Biologics",48527,"Terminated","Florida's Blood Centers, Inc.","Orlando","FL","US","Voluntary: Firm Initiated","Telephone","Florida","B-1061-13","Class II","Platelets Pheresis Leukocytes Reduced, Part 1 of 3, Part 2 of 3 and Part 3 of 3.","9912770 (Part A); 9912770(Part B); 9912770(Part C) ",".","3 units","Blood products, platelet pheresis leukocytes reduced with an unacceptable pH, were distributed. ",12/11/2007,"12/11/2007",5/15/2013,"05/15/2013"
"Biologics",48537,"Terminated","Community Blood Center Of Gtr KC","Kansas City","MO","US","Voluntary: Firm Initiated","E-Mail","Austria","B-0302-13","Class II","Blood and Blood Products for Reprocessing","W045007111458",".","1 unit","Blood products, collected from a donor who was at risk for variant Creutzfeldt-Jakob disease (vCJD), were distributed.",4/16/2008,"04/16/2008",1/2/2013,"01/02/2013"
"Biologics",48541,"Terminated","American Red Cross Blood Services","Omaha","NE","US","Voluntary: Firm Initiated","FAX","Iowa, Nebraska","B-1198-13","Class II","Red Blood Cells Leukocytes Reduced","009E11831",".","1 unit","Blood products, collected from a donor for whom donor suitability was not adequately determined, were distributed.",4/11/2008,"04/11/2008",5/1/2013,"05/01/2013"
"Biologics",48541,"Terminated","American Red Cross Blood Services","Omaha","NE","US","Voluntary: Firm Initiated","FAX","Iowa, Nebraska","B-1199-13","Class II","Fresh Frozen Plasma","009E11831",".","1 unit","Blood products, collected from a donor for whom donor suitability was not adequately determined, were distributed.",4/11/2008,"04/11/2008",5/1/2013,"05/01/2013"
"Biologics",48543,"Terminated","American National Red Cross","Boise","ID","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Idaho and California.","B-1102-13","Class III","Blood and Blood Products for Reprocessing","20FM43725",,"1 component","Blood products, collected from a donor whose suitability to donate was not adequately determined, were distributed.",4/17/2008,"04/17/2008",5/22/2013,"05/22/2013"
"Biologics",48543,"Terminated","American National Red Cross","Boise","ID","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Idaho and California.","B-1103-13","Class II","Red Blood Cells Leukocytes Reduced","20FM43725",,"1 component","Blood products, collected from a donor whose suitability to donate was not adequately determined, were distributed.",4/17/2008,"04/17/2008",5/22/2013,"05/22/2013"
"Biologics",48545,"Terminated","American National Red Cross (The)","West Henrietta","NY","US","Voluntary: Firm Initiated","FAX","PA","B-1290-13","Class II","Platelets Pheresis Leukocytes Reduced Irradiated","01FP60383",".","1 unit ","Blood product, collected from a donor in which donor suitability was not adequately determined, was distributed.",4/9/2008,"04/09/2008",7/10/2013,"07/10/2013"
"Biologics",48554,"Terminated","Blood Systems Inc","Scottsdale","AZ","US","Voluntary: Firm Initiated","E-Mail","WY, Switzerland","B-1115-13","Class II","Blood and Blood Products for Reprocessing","181799600, 184284750",,"2 units","Blood products, collected from a donor who reported testing positive for hepatitis, were distributed.",4/29/2008,"04/29/2008",5/22/2013,"05/22/2013"
"Biologics",48554,"Terminated","Blood Systems Inc","Scottsdale","AZ","US","Voluntary: Firm Initiated","E-Mail","WY, Switzerland","B-1116-13","Class II","Red Blood Cells Leukocytes Reduced","181799600, 184284750",,"2 units","Blood products, collected from a donor who reported testing positive for hepatitis, were distributed.",4/29/2008,"04/29/2008",5/22/2013,"05/22/2013"
"Biologics",48584,"Terminated","American National Red Cross","Salt Lake City","UT","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Montana.","B-1027-13","Class II","Red Blood Cells Leukocytes Reduced","20GH52851",,"1 component","Blood product, collected from a donor who traveled to a malarial endemic area, was distributed.",4/16/2008,"04/16/2008",5/8/2013,"05/08/2013"
"Biologics",48723,"Terminated","BioLife Plasma Services L.P.","Van Nuys","CA","US","Voluntary: Firm Initiated","E-Mail","California","B-2066-13","Class III","Source Plasma","52947810 ,52952302 ,52985348 ,52992261 ,52996900 , 53000354 ,53353603 ,53665614 ,53890016 ,54143128 , 57567679 ,57569635 ,61844841 ,61849853 ,62426619 , 62534192 ,62538435 ,62540117 ,62940078 ,62980616 , 63409383 ,63673265 ,63683431 ,63687392 ,63955064 , 63960624 ,63960846 ,63961997 ,63968668 ,64360294 , 64428642 ,64428680 ,64432625 ,64432649 ,64435985 , 64436012 ,64438764 ,64438771 ,64830100 ,65039977 , 65041956 ,65045268 ,65059777 ,65062838 ,65065402 , 65346020 ,65601594 ,65631010 ,65765173 ,65979266 , 65992234 ,66101284 ,66118299 ,66123613 ,66129721 , ,66212874 ,66215868 ,66222347 ,66225560 ,66231820 , 66397120 ,66401872 ,66404101 ,66413806 ,66769415 , 66843870 ,67078288 ,67078325 ,67101436 ,67536085 , 67551064 ,67597604 ,67602841 ,67615582 ,67623945 , 67630851 ,67639137 ,67703975 ,67709090 ,67718320 , 67754816 ,67755486 ,67763788 ,67767731 ,67774197 , 67779598 ,67793334 ,67795321 ,67838967 ,67843060 , 67848621 ,67852291 ,67881901 ,68095321 ,68099824 , 68101244 ,68166915 ,68173043 ,68795290 ,68798208 , 68808037 ,68863401 ,68869908 ,69194924 ,69198038 , 69203411 ,69206870 ,69211508 ,69244131 ,69246098 , 69555954 ,69563355 ,69895364 ,69898624 ,69904578 , 69909580 ,69918889 ,69922930 ,69925238 ,69930768 , 69944673 ,70486230 ,71187525 ,71189567 ,71193267 , 71195988 ,71198330 ,71199047 ,71199054 ,71202969 , 71204673 ,71205328 ,71254173 ,71257075 ,71467153 , 71581026 ,71584263 ,71805702 ,72244838 ,72245842 , 72380796 ,72381748 ,72383452 ,72484333 ,72601082 , 72609309 ,72604120 ,72626177 ,72629222 ,72707777 , 72807668 ,72869338 ,72901656 ,73070283 ,73244875 , 73246701 ,73248002 ,73443797 ,73457107 ,73477617 , 73558620 ,73806417 ,73807384 ,73809159 ,73810148 , 73853152 ,73855743 ,73857747 ,73859420 ,73889731 , 74014156 ,74016952 ,74462100 ,74465552 ,74537709 , 74539390 ,74670260 ,74706921 ,74885701 ,74886586 , 74932528 ,74932696 ,74973750 ,74974870 ,75120863 , 75122966 ,75177539 ,75243739 ,75437572 ,75438142 , 75440008 ,75442729 ,75444570 ,75521318 ,75522667 , 75524661 ,7552595",".","287","Blood products, which were not quarantined subsequent to receiving information regarding post donation information, were distributed.",6/23/2008,"06/23/2008",8/14/2013,"08/14/2013"
"Veterinary",48735,"Ongoing","Merit Bird Co Llc","Chatsworth","CA","US","Voluntary: Firm Initiated","Press Release","CA","V-299-2013","Class I","Vitae Large Hookbill 4lbs","#2840279",,"112 bags","Merit Bird Company is recalling Vitae brand bird food because it has the potential to be contaminated with Salmonella. Vitae brand bird food contains parsley that has been recalled by Specialty Commodities due to Salmonella.",4/18/2013,"04/18/2013",9/4/2013,"09/04/2013"
"Veterinary",48735,"Ongoing","Merit Bird Co Llc","Chatsworth","CA","US","Voluntary: Firm Initiated","Press Release","CA","V-296-2013","Class I","Vitae Cockatiel with Sunflower, 2lbs and 4lbs","2lbs: #2840081 4lbs: #2840090",,"140 bags","Merit Bird Company is recalling Vitae brand bird food because it has the potential to be contaminated with Salmonella. Vitae brand bird food contains parsley that has been recalled by Specialty Commodities due to Salmonella.",4/18/2013,"04/18/2013",9/4/2013,"09/04/2013"
"Veterinary",48735,"Ongoing","Merit Bird Co Llc","Chatsworth","CA","US","Voluntary: Firm Initiated","Press Release","CA","V-298-2013","Class I","Vitae Hookbill with Sunflower, 4lbs","#2840252",,"103 bags","Merit Bird Company is recalling Vitae brand bird food because it has the potential to be contaminated with Salmonella. Vitae brand bird food contains parsley that has been recalled by Specialty Commodities due to Salmonella.",4/18/2013,"04/18/2013",9/4/2013,"09/04/2013"
"Veterinary",48735,"Ongoing","Merit Bird Co Llc","Chatsworth","CA","US","Voluntary: Firm Initiated","Press Release","CA","V-297-2013","Class I","Vitae Small Hookbill, 4lbs.","#2840225",,"98 bags","Merit Bird Company is recalling Vitae brand bird food because it has the potential to be contaminated with Salmonella. Vitae brand bird food contains parsley that has been recalled by Specialty Commodities due to Salmonella.",4/18/2013,"04/18/2013",9/4/2013,"09/04/2013"
"Biologics",48774,"Terminated","Florida Blood Services, Inc.","Pensacola","FL","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","FL","B-1157-13","Class II","Red Blood Cells Leukocytes Reduced","4111626",".","1 unit","Blood product, collected from a donor in which donor suitability was not adequately determined, was distributed.",8/29/2007,"08/29/2007",5/29/2013,"05/29/2013"
"Biologics",48776,"Terminated","Florida Blood Services, Inc.","Pensacola","FL","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","FL","B-1159-13","Class II","Platelets Pheresis Leukocytes Reduced"," 4573208A; 4573208C",,"2 units","Blood products, which did not meet the acceptable product specifications, were distributed.",6/11/2008,"06/11/2008",5/22/2013,"05/22/2013"
"Biologics",48782,"Terminated","The American National Red Cross - Southern Region","Douglasville","GA","US","Voluntary: Firm Initiated","Letter","CA & GA","B-0870-13","Class II","Red Blood Cells Leukocytes Reduced Irradiated","03KH34072",,"1 unit","Blood products, collected from a donor whose suitability to donate was not adequately determined, were distributed.",4/23/2008,"04/23/2008",4/3/2013,"04/03/2013"
"Biologics",48782,"Terminated","The American National Red Cross - Southern Region","Douglasville","GA","US","Voluntary: Firm Initiated","Letter","CA & GA","B-0871-13","Class III","Plasma Cryoprecipitated Reduced","03KH34072",,"1 unit","Blood products, collected from a donor whose suitability to donate was not adequately determined, were distributed.",4/23/2008,"04/23/2008",4/3/2013,"04/03/2013"
"Biologics",48783,"Terminated","The American National Red Cross - Southern Region","Douglasville","GA","US","Voluntary: Firm Initiated","FAX","CA & GA","B-0872-13","Class III","Blood and Blood Products for Reprocessing","003LH13062",,"1 unit","Blood products, collected from a donor whose suitability to donate was not adequately determined, were distributed.",5/1/2008,"05/01/2008",4/3/2013,"04/03/2013"
"Biologics",48783,"Terminated","The American National Red Cross - Southern Region","Douglasville","GA","US","Voluntary: Firm Initiated","FAX","CA & GA","B-0873-13","Class II","Red Blood Cells Leukocytes Reduced","003LH13062",,"1 unit","Blood products, collected from a donor whose suitability to donate was not adequately determined, were distributed.",5/1/2008,"05/01/2008",4/3/2013,"04/03/2013"
"Biologics",48801,"Terminated","LifeSouth Community Blood Centers, Inc.","Gainesville","FL","US","Voluntary: Firm Initiated","FAX","FL","B-1160-13","Class II","Platelets","72F887558",".","1 unit","Quality Control and Distribution/Distribution of product that did not meet specifications. Product in which instrument QC or validation was unacceptable, incomplete, not performed, or not documented.",6/10/2008,"06/10/2008",5/29/2013,"05/29/2013"
"Biologics",48802,"Terminated","Community Blood Centers of South Florida, Inc.","Lauderhill","FL","US","Voluntary: Firm Initiated","Telephone","Florida","B-1557-13","Class II","Red Blood Cells (Apheresis) Leukocytes Reduced","2685957",,"1 unit","Blood product, labeled with incorrect or missing information, expiration date, was distributed. ",5/16/2008,"05/16/2008",7/3/2013,"07/03/2013"
"Biologics",48835,"Terminated","Blood Systems, Inc.","El Paso","TX","US","Voluntary: Firm Initiated","Letter","TX","B-0252-13","Class II","Platelets Pheresis Leukocytes Reduced Irradiated","W04110800723900 (2 units)",".","2 units","Blood products, which were labeled as leukoreduced, but were not tested to verify white blood cell count, were distributed.",6/9/2008,"06/09/2008",2/6/2013,"02/06/2013"
"Biologics",48851,"Terminated","LifeServe Blood Center","Des Moines","IA","US","Voluntary: Firm Initiated","Letter","Iowa","B-0899-13","Class II","Red Blood Cells Leukocytes Reduced","LF41206",".","1 Unit","Blood products, collected from a donor taking the drug Finasteride, were distributed.",5/27/2008,"05/27/2008",4/24/2013,"04/24/2013"
"Biologics",48851,"Terminated","LifeServe Blood Center","Des Moines","IA","US","Voluntary: Firm Initiated","Letter","Iowa","B-0900-13","Class II","Plasma Frozen","LF41206",".","1 Unit","Blood products, collected from a donor taking the drug Finasteride, were distributed.",5/27/2008,"05/27/2008",4/24/2013,"04/24/2013"
"Biologics",48852,"Terminated","LifeServe Blood Center","Des Moines","IA","US","Voluntary: Firm Initiated","Letter","Iowa","B-0903-13","Class II","Red Blood Cells Leukocytes Reduced","LF43720",".","1 Unit","Blood product, collected from a donor who reported travel to a malarial endemic area, was distributed.",6/9/2008,"06/09/2008",4/10/2013,"04/10/2013"
"Biologics",48853,"Terminated","LifeServe Blood Center","Des Moines","IA","US","Voluntary: Firm Initiated","Letter","Iowa","B-0979-13","Class II","Red Blood Cells (Apheresis)","W037908108661",,"1 Unit","Blood products, which did not meet the acceptable product specifications for release, were distributed.",6/5/2008,"06/05/2008",4/17/2013,"04/17/2013"
"Biologics",48856,"Terminated","Community Blood Center Of Gtr KC","Kansas City","MO","US","Voluntary: Firm Initiated","Telephone","Kansas; Missouri","B-0348-13","Class III","Platelets Pheresis Leukocytes Reduced","W045008906241; W045008906253; W04500905684; W045008905688; W045008900312; W045008906240; W045008906244; W045008906405; W045008906405; W045008903920; W045008905682; W045008905696; W045008906241",".","13 Units","Blood products, which may have been exposed to unacceptable temperatures during storage, were distributed.",5/22/2008,"05/22/2008",1/9/2013,"01/09/2013"
"Biologics",48858,"Terminated","American National Red Cross (The)","Saint Louis","MO","US","Voluntary: Firm Initiated","Letter","IL and MO","B-0578-13","Class II","Red Blood Cells Leukocytes Reduced","011KC32262; 011KC34046",".","2 units","Blood products, collected from a donor whose suitability to donate was not adequately determined, were distributed. ",5/24/2008,"05/24/2008",2/27/2013,"02/27/2013"
"Biologics",48858,"Terminated","American National Red Cross (The)","Saint Louis","MO","US","Voluntary: Firm Initiated","Letter","IL and MO","B-0577-13","Class III","Blood and Blood Products for Reprocessing","011KC32262; 011KC34046",".","2 units","Blood products, collected from a donor whose suitability to donate was not adequately determined, were distributed. ",5/24/2008,"05/24/2008",2/27/2013,"02/27/2013"
"Biologics",48862,"Terminated","Childrens Hospital Los Angeles","Los Angeles","CA","US","Voluntary: Firm Initiated","Letter","CA","B-2157-13","Class III","Blood and blood products for reprocessing","W070008001819",".","1","Blood products, collected from a donor who was previously deferred, were distributed.",7/1/2008,"07/01/2008",10/2/2013,"10/02/2013"
"Biologics",48864,"Terminated","Tri-counties Blood Bank","Phoenix","AZ","US","Voluntary: Firm Initiated","Telephone","CA","B-1877-13","Class II","Red Blood Cells (Apheresis) Leukocytes Reduced","W142808202624; W142808202624; W142808202626; W142808202626",,"4 units","Blood products, which did not meet the acceptable product specifications, were distributed. ",6/3/2008,"06/03/2008",8/7/2013,"08/07/2013"
"Biologics",48867,"Terminated","American National Red Cross (The)","Pomona","CA","US","Voluntary: Firm Initiated","Telephone","California","B-1519-13","Class III","Blood and Blood Products for Reprocessing","06GT60067",,"1 unit","Blood products, which were collected from a donor in which donor suitability was not adequately determined, were distributed",5/9/2008,"05/09/2008",6/26/2013,"06/26/2013"
"Biologics",48867,"Terminated","American National Red Cross (The)","Pomona","CA","US","Voluntary: Firm Initiated","Telephone","California","B-1520-13","Class II","Red Blood Cells Leukocytes Reduced","06GT60067",,"1 unit","Blood products, which were collected from a donor in which donor suitability was not adequately determined, were distributed",5/9/2008,"05/09/2008",6/26/2013,"06/26/2013"
"Biologics",48869,"Terminated","American National Red Cross (The)","Tucson","AZ","US","Voluntary: Firm Initiated","Telephone","Arizona","B-2035-13","Class II","Red Blood Cells Leukocytes Reduced","07FY74209",".","1 unit","Blood product, in which donor gave history which warranted deferral or follow up questions was not asked, was distributed.",6/12/2008,"06/12/2008",8/14/2013,"08/14/2013"
"Biologics",48870,"Terminated","Community Blood Bank, Inc.","Rancho Mirage","CA","US","Voluntary: Firm Initiated","Letter","California.","B-2325-13","Class II","Red Blood Cells Leukocytes Reduced","9312189; 3502491",,"2 units","Blood products, which were collected from a donor who traveled to malarial endemic areas, were distributed. ",6/20/2008,"06/20/2008",9/25/2013,"09/25/2013"
"Biologics",48872,"Terminated","Talecris Plasma Resources Inc Dba International Bioresources","Research Triangle Park","NC","US","Voluntary: Firm Initiated","FAX","North Carolina","B-1699-13","Class III","Source Plasma","368078740, 368078739, 368078741, 368078742, 368078743, 368078744, 368078745, 368078746, 368078747, 368078749, 368078750, 368078751",".","12 units","Source Plasma, which reached unacceptable temperatures during storage and was not relabeled as Source Plasma, Salvaged, was distributed.",6/18/2008,"06/18/2008",7/24/2013,"07/24/2013"
"Biologics",48873,"Terminated","Talecris Plasma Resources Inc Dba International Bioresources","Research Triangle Park","NC","US","Voluntary: Firm Initiated","FAX","North Carolina","B-1667-13","Class III","Source Plasma","368096614",".","1 unit","Blood product, collected from a donor whose arm inspection was not documented, was distributed.",6/21/2008,"06/21/2008",7/24/2013,"07/24/2013"
"Biologics",48907,"Terminated","American National Red Cross","Portland","OR","US","Voluntary: Firm Initiated","Telephone","Massachusetts, California, New York, and Oregon.","B-1499-13","Class II","Cryoprecipitated AHF","21LZ01676; 21LZ08395",,"2 components","Blood products, collected from a donor in whom donor suitability was not adequately determined, were distributed.",6/2/2008,"06/02/2008",6/26/2013,"06/26/2013"
"Biologics",48907,"Terminated","American National Red Cross","Portland","OR","US","Voluntary: Firm Initiated","Telephone","Massachusetts, California, New York, and Oregon.","B-1497-13","Class III","Blood and Blood Products for Reprocessing","21LZ01676; 21LZ08395",,"2 components","Blood products, collected from a donor in whom donor suitability was not adequately determined, were distributed.",6/2/2008,"06/02/2008",6/26/2013,"06/26/2013"
"Biologics",48907,"Terminated","American National Red Cross","Portland","OR","US","Voluntary: Firm Initiated","Telephone","Massachusetts, California, New York, and Oregon.","B-1498-13","Class II","Red Blood Cells Leukocytes Reduced","21LZ01676; 21LZ08395",,"2 components","Blood products, collected from a donor in whom donor suitability was not adequately determined, were distributed.",6/2/2008,"06/02/2008",6/26/2013,"06/26/2013"
"Biologics",48908,"Terminated","American National Red Cross","Portland","OR","US","Voluntary: Firm Initiated","Letter","Ohio.","B-0761-13","Class II","Red Blood Cells","21GV49837",,"1 unit","Blood product, collected from a donor who traveled to an area considered endemic for malaria, was distributed.",5/20/2008,"05/20/2008",4/3/2013,"04/03/2013"
"Biologics",48909,"Terminated","American National Red Cross","Portland","OR","US","Voluntary: Firm Initiated","Letter","Oregon.","B-0190-13","Class III","Red Blood Cells Leukocytes Reduced","21KS76848; 21KS76854; 21KS76857",,"3 Components","Blood products, lacking assurance of having been maintained at an acceptable temperature during shipping or storage, were distributed.",6/4/2008,"06/04/2008",3/20/2013,"03/20/2013"
"Biologics",48910,"Terminated","American National Red Cross","Portland","OR","US","Voluntary: Firm Initiated","FAX","Maryland.","B-0166-13","Class II","Red Blood Cells Leukocytes Reduced","21KM96454",".","1 component","Blood product, collected from a donor who reported post donation illness, was distributed.",6/10/2008,"06/10/2008",1/23/2013,"01/23/2013"
"Biologics",48914,"Terminated","BioLife Plasma Services L.P.","Cedar Rapids","IA","US","Voluntary: Firm Initiated","FAX","Austria","B-1092-13","Class II","Source Plasma","08CIAB7249",".","1 Unit","Blood products, collected from a donor who was not asked vCJD travel questions, was distributed.",5/21/2008,"05/21/2008",5/15/2013,"05/15/2013"
"Biologics",48915,"Terminated","Community Blood Center of the Ozarks","Springfield","MO","US","Voluntary: Firm Initiated","Telephone","Arkansas; Austria","B-0914-13","Class II","Blood and Blood Products for Reprocessing","6883678",".","1 Unit","Blood products, collected from a donor who was previously deferred, were distributed. ",5/8/2008,"05/08/2008",4/10/2013,"04/10/2013"
"Biologics",48915,"Terminated","Community Blood Center of the Ozarks","Springfield","MO","US","Voluntary: Firm Initiated","Telephone","Arkansas; Austria","B-0915-13","Class II","Red Blood Cells","6883678",".","1 Unit","Blood products, collected from a donor who was previously deferred, were distributed. ",5/8/2008,"05/08/2008",4/10/2013,"04/10/2013"
"Biologics",48941,"Terminated","American National Red Cross (The)","West Henrietta","NY","US","Voluntary: Firm Initiated","Letter","NY","B-1663-13","Class III","Blood and Blood Products for Reprocessing","01KT10802",".","1 unit","Blood product, collected from a donor in which donor suitability was not adequately determined, was distributed.",5/27/2008,"05/27/2008",7/10/2013,"07/10/2013"
"Biologics",48941,"Terminated","American National Red Cross (The)","West Henrietta","NY","US","Voluntary: Firm Initiated","Letter","NY","B-1664-13","Class II","Red Blood Cells Leukocytes Reduced","01KT10802",".","1 unit","Blood product, collected from a donor in which donor suitability was not adequately determined, was distributed.",5/27/2008,"05/27/2008",7/10/2013,"07/10/2013"
"Biologics",48953,"Terminated","Biomat USA, Inc.","Portland","OR","US","Voluntary: Firm Initiated","Letter","Spain and California","B-0220-13","Class III","Source Plasma","0530052514, 0530052215, 0530050895, 0530050580, 0530047198, 0530046819, 0530046556, 0530046177, 0530045908, 0530045575, 0530045209, 0530044864, 0530044645, 0530044165, 0530043843, 0530043544, 0530043221, 0530042952, 0530042614, 0530042283, 0530041970, 0530041692, 0530041301, 0530040953, 0530040591, 0530040201, 0530040019, 0530039491, 0530039298, 0530038835, 0530038580, 0530038196, 0530037947, 0530037640, 0530037395, 0530037079, 0530036854, 0530036272, 0530035763, 0530035112, 0530034619, 0530034010, 0530033447, 0530031462, 0530031138, 0530030785, 0530030640, 0530030316, 0530029897, 0530029726, 0530029139, 0530028900, 0530028569, 0530028132, 0530024940, 0530024718, 0530024335, 0530024098, 0530023670, 0530023432, 0530023031. ",,"61 units","Blood products, collected from a donor who was previously deferred, were distributed.",3/17/2008,"03/17/2008",3/13/2013,"03/13/2013"
"Devices",48997,"Terminated","Respironics California Inc","Carlsbad","CA","US","Voluntary: Firm Initiated","Letter","Unted States Nationwide, and Worldwide to Algeria, Argentina, Australia, Bangladesh, Brazil, Cambodia, Canada, Chile, Colombia, Ecuador, Egypt, France, Germany, Guatemala, Hong Kong, India, Italy, Japan, Libya, Malaysia, Mexico, Pakistan, Peru, Philippines, Puerto Rico, Russia, South Africa, South Korea, Spain, Taiwan, Thailand, Turkey, United Arab Emirates, United Kingdom, Venezuela, and Vietnam.","Z-2084-2013","Class II","Continuous Ventilator/Continuous Ventilator with Respiratory Mechanics, Model No. V1000","Model Number: V1000",,"3,255 units (2302 units in US)","Respironics is recalling the Esprit Ventilator because the power to the Esprit Display's Backlight is interrupted, causing the GUI to flicker or go dark and making the display unreadable.",10/29/2007,"10/29/2007",9/4/2013,"09/04/2013"
"Food",49017,"Terminated","Servatii Inc","Cincinnati","OH","US","Voluntary: Firm Initiated","Telephone","Product was distributed to the 11 Servatii retail locations.","F-1251-2013","Class II","Banana Nut Bread packed in carton, placed in polypropelin Bag 1 lb each","Bar Code 0 36746 03961 5",,"90/1 lb packages","The firm had pecans and not walnuts listed in their ingredient statement.",6/9/2008,"06/09/2008",4/3/2013,"04/03/2013"
"Devices",49026,"Ongoing","Alere San Diego, Inc.","San Diego","CA","US","Voluntary: Firm Initiated","Letter","Nationwide distribution: USA including states of: AL, AK, AR, AZ, CA, CO, CT, DE, HI, IA, ID, IL, IN, FL, GA, KY, KS, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, SC, UT, TN, TX, VA, WA, WI, WV AND WY.","Z-1344-2013","Class III","Cardinal Health hCG Cassette Rapid Test, Part Number: B1077-22 (Mfg PN: 4582105026) The SP hCG Cassette Rapid Test is a rapid chromatographic immunoassay for the qualitative detection of human chorionic gonadotropin (hCG) in urine, as an aid in the early detection of pregnancy. This test is for professional use.","Lot: hCG2080330",".","2,167 kits","Alere San Diego Inc. is recalling the Cardinal Health hCG Cassette Rapid Test because some of them were incorrectly packaged into Cardinal Health hCG Combo Rapid test kit boxes. The kit box incorrectly indicates the product may be used for both urine and serum sample types.",1/21/2013,"01/21/2013",5/29/2013,"05/29/2013"
"Devices",49033,"Ongoing","Fisher & Paykel Healthcare, Ltd.","North Shore City",,"NZ","Voluntary: Firm Initiated","Letter","Worldwide distribution: USA (nationwide) and countries of: Canada, Japan, and Taiwan.","Z-1437-2013","Class II","Fisher & Paykel Healthcare ICON CPAP (continuous positive airway pressure). Models: ICON Auto: ICONAAN, ICONAAN-HT, ICONAAJ. ICON Novo: ICONNAN, ICONNAN-HT, ICONNAJ. ICON Premo: ICONPBN, ICONPBN-HT, ICONPBN-HTC. The ICON CPAP unit is for use on adult patients for the treatment of Obstructive Sleep Apnea (OSA). The device is for use in the home or sleep laboratory. The device is not intended to be used as a life supporting device.","Lot 121210: December 10th, 2012. Lot 121221: December 21st, 2012.",".","1,407 units","Fisher and Paykel Healthcare is recalling the ICON CPAP units because there is a potential power issue on certain ICON CPAP. These ICON CPAP units could potentially become inoperable, which would result in a lack of treatment to the patient's obstructive sleep apnea symptoms until a replacement unit is obtained.",4/22/2013,"04/22/2013",6/5/2013,"06/05/2013"
"Drugs",49085,"Ongoing","Chang Kwung Products","Woodland Hills","CA","US","Voluntary: Firm Initiated","Letter","Nationwide","D-834-2013","Class I","Lightning ROD capsules, 550 mg/capsule, packaged in 12-count bottles (UPC 6 89076 20297 8). ","No lot codes are printed on the product",".","3,720 capsules total","Marketed Without An Approved NDA/ANDA: Lightning Rod capsules are being recalled because FDA analysis found it to contain an undeclared analogue of sildenafil. Sildenafil is the active ingredient in an FDA-approved product indicated for the treatment of male erectile dysfunction (ED), making this product an unapproved new drug.",5/6/2013,"05/06/2013",8/14/2013,"08/14/2013"
"Drugs",49085,"Ongoing","Chang Kwung Products","Woodland Hills","CA","US","Voluntary: Firm Initiated","Letter","Nationwide","D-833-2013","Class I","Lightning ROD capsules, 500 mg/capsule, packaged in 3-count bottles (UPC 6 89076 20257 2). ","No lot codes are printed on the product",".","3,720 capsules total","Marketed Without An Approved NDA/ANDA: Lightning Rod capsules are being recalled because FDA analysis found it to contain an undeclared analogue of sildenafil. Sildenafil is the active ingredient in an FDA-approved product indicated for the treatment of male erectile dysfunction (ED), making this product an unapproved new drug.",5/6/2013,"05/06/2013",8/14/2013,"08/14/2013"
"Biologics",49155,"Terminated","Blood Bank of San Bernardino and Riverside Counties","San Bernardino","CA","US","Voluntary: Firm Initiated","Letter","California","B-2505-13","Class III","Red Blood Cells Leukocytes Reduced, codes: LRC6, LRC5, LRC3 ","GX94804 GW62803 GW62801 GX94808 GW62805 GX94803 GQ54219 GQ54221 GX94794 GX94799 GX94795 GX94790 GX94757 GX94758 GX94751 GX94760 GX94755 GX94763 GX94752 GX94767 GX94764 GX94768 GX94749 GX94761 GX94769 GX94754 GQ54034 GQ54017 GQ54016 Y96446 Y96451 GQ54217 Y96439 Y96442 Y96409 Y96422 Y96420 GY09002 GW79371 GW79385 GW79386 GW79382 GW79375 GW79376 GW79373 GY09002 GW79371 GW79385 GW79386 GW79382 GW79375 GW79376 GW79373 Y99056 Y99045 GC01624 GW79641 GW79640 GC01624 GW79641 GW79640 GN84524 GN84517 GN84526 GN84515 GN84529 GN84521 GN84525 GN84530 GN84520 GN84518 GN84522 GN84519 GN84523 GN84516 GQ54032 GQ54033 GQ54038 GQ54035 GQ54036 GQ54037 GQ54014 GQ54009 GQ54010 GQ54013 GQ54011 GQ54012 GN85176 GN85025 GN85180 GN85171 GN58184 GN85174 GN85181 GN85026 GN85024 GN85028 GN85029 GN85020 GC00015 GC00017 GP99721 GC00011 GP99719 GP99711 GP99714 GP99712 GP99707 GP99713 GP99709 GP99718 GP99706 GP99717 GP99720 GP99710 GP99708 GC00012 GC00007 GC00003 GC00010 GC00005 GC00004 GC00001 GC00008 GC00006 GC00009 GC00002 GC00965 GC00968 GC00961 GC00962 GC00963 GC00970 GC00972 GC00974 GC00966 GC00967 GW79365 GW79370 GW79367 GW79380 GW79377 GW79374 GW79378 GW79379 GC00015 GC00017 GP99721 GC00011 GP99719 GP99711 GP99714 GP99712 GP99707 GP99713 GP99709 GP99718 GP99706 GP99717 GP99720 GP99710 GP99708 GC00012 GC00007 GC00003 GC00010 GC00005 GC00004 GC00001 GC00008 GC00006 GC00009 GC00002 GC00971 GC00965 GC00968 GC00961 GC00962 GC00963 GC00970 GC00972 GC00974 GC00966 GC00967 GW79365 GW79367 GW79370 GW79380 GW79377 GW79374 GW79378 GW79379 GW65933 GW65996 GW65991 GQ57357 GW65988 GQ57355 GQ57356 GW65995 GQ57359 GQ57360 GW65992 GW65994 GW65989 GQ57358 GW65990 GP03563 GP03564 GP03571 GP03566 GP03578 GP03574 GX99640 GX99651 GX99641 GX99648 GX99649 GX99647 GP03514 GP03510 GP03513 GP03502 GP03507 GP03516 GP03503 GP03508 GP03534 GP03535 GP03547 GP03504 GP03506 GP03511 GP03509 GP03518 GP03505 GW79644 gc01621 GW79639 GC01625 GW79638 GW79643 GC00976 GC01623 GC01617 GC01622 GC01615 GC01616 GW79637 GC00975 GC00978 GC01620 GC01613 GC00977 GW79644 GC01621 GW7963"," GX95137 GX95139 GX95140 GX95141 GX95219 GX95222 GX95223 GX95228 GX95234 GX95236 GX95237 GX95241 GX95242 GX95243 GX95244 GX95342 GX95350 GX97382 GX97383 GX97387 GX97392 GX97395 GX97398 GX97421 GX98804 GX99124 GX99126 GX99127 GX99128 GX99129 GX99131 GX99133 GX99134 GX99135 GX99176 GX99177 GX99182 GX99183 GX99184 GX99186 GX99188 GX99192 GX99193 GX99195 GX99197 GX99199 GX99200 GX99201 GX99202 GX99205 GX99206 GX99207 GX99209 GX99211 GX99220 GX99222 GX99223 GX99233 GX99234 GX99236 GX99237 GX99238 GX99241 GX99243 GX99244 GX99245 GX99246 GX99623 GX99625 GX99630 GX99635 GX99636 GX99639 GX99815 GY07496 GY07498 GY07498 GY07499 GY07501 GY07502 GY07502 GY07504 GY07504 GY07505 GY07505 GY08264 GY08265 GY08266 GY08267 GY08268 GY08269 GY08270 GY08271 GY08272 GY08273 GY08274 GY08275 GY09923 GY09924 GY09926 GY09930 GY09935 GZ02323 GZ02325 GZ02326 GZ02328 GZ02346 GZ02348 GZ02349 GZ03246 GZ03247 GZ03248 GZ03249 GZ03250 GZ03252 GZ03253 GZ03254 GZ03255 GZ03256 GZ03298 GZ03299 GZ03300 GZ03301 GZ03303 GZ03304 GZ03306 GZ03307 GZ03312 GZ03313 GZ03314 GZ03315 GZ03316 GZ03319 GZ03320 GZ03328 GZ03329 GZ03331 GZ03332 GZ03333 GZ03334 GZ03335 GZ03336 GZ03337 GZ03339 GZ03340 GZ03341 GZ03342 GZ03343 GZ03344 GZ03345 GZ03346 GZ03347 GZ03348 GZ03349 GZ03351 GZ03353 GZ03355 GZ03356 GZ03358 GZ03359 GZ03360 GZ03361 GZ03362 GZ03363 GZ03364 GZ03365 GZ03366 GZ03367 GZ03368 GZ03369 GZ03371 GZ03372 GZ03373 GZ03376 GZ03377 GZ03378 GZ03379 GZ03484 GZ03485 GZ03486 GZ03488 GZ03489 GZ03491 GZ03493 GZ03494 GZ03495 GZ03498 GZ03499 GZ03501 GZ03522 GZ03653 GZ03728 GZ03729 GZ03730 GZ03731 GZ03732 GZ03742 GZ03743 GZ03745 GZ03748 GZ03749 GZ03750 GZ03751 GZ03752 GZ03753 GZ03755 GZ03756 GZ03757 GZ03759 GZ03860 GZ03861 GZ03862 GZ03863 GZ03865 GZ03956 GZ04019 GZ04020 GZ04021 GZ04022 GZ04023 GZ04026 GZ04027 GZ04028 GZ04029 GZ04031 GZ04032 GZ04034 GZ04035 GZ04036 GZ04037 GZ04038 GZ04039 GZ04040 GZ04041 GZ04043 GZ04044 GZ04045 GZ04188 GZ04189 GZ04190 GZ04191 GZ04192 GZ04193 GZ04194 GZ04195 GZ04196 GZ04199 GZ04202 GZ04203 GZ04204 GZ04206 GZ04207 GZ04208 GZ04210 GZ04211 GZ04","3972 units","Blood products, which exceeded time limits taken out of storage for labeling, were distributed.",8/19/2008,"08/19/2008",11/6/2013,"11/06/2013"
"Biologics",49155,"Terminated","Blood Bank of San Bernardino and Riverside Counties","San Bernardino","CA","US","Voluntary: Firm Initiated","Letter","California","B-2508-13","Class III","Cryoprecipitated AHF, Pooled, Code: PCRY","G09140 G09139 G09138 G07119 G07120 G07121 G07122 G07123 G07124 G07125 G07126 G07127 G07130 G07131 G07132 G07145 G07146 G07147 G07148 G07149 G07151 G07152 G07153 G07154 G07155 G07157 G07158 G07169 G07170 G07171 G07172 G07173 G07174 G07175 G07176 G07177 G07178 G07181 G07182 G07183 G07184 G08324 G08325 G08326 G08327 G08329 G08330 G08382 G08409 G08410 G08411 G08426 G08427 G08971 G08972 G08977 G08979 G09087 G09088 G09089 G09090 G09091 ",,"60 units","Blood products, which exceeded time limits taken out of storage for labeling, were distributed.",8/19/2008,"08/19/2008",11/6/2013,"11/06/2013"
"Biologics",49155,"Terminated","Blood Bank of San Bernardino and Riverside Counties","San Bernardino","CA","US","Voluntary: Firm Initiated","Letter","California","B-2506-13","Class III","Platelets Pheresis Leukocytes Reduced, Codes: LPAA, LPAB, LPA, LPAC","GS50898 GS50917 GS50919 GS66370 GS66372 GS66373 GS68610 GS68614 GS68616 GS68617 GS68620 GS68621 GS68622 GS68627 GS68922 GS69379 GS69381 GS69463 GS69464 GS70344 GS70345 GS70346 GS70406 GS70407 GS70408 GS70410 GS70411 GS70412 GS70417 GS72560 GS72561 GS72566 GS72567 GS72913 GS72914 GS72915 GS72916 GS72918 GS72922 GS72923 GS73455 GS75510 GS75510 GS75512 GS75512 GS75530 GS75537 GS77276 GS77282 GS77287 GS77290 GS77291 GS77294 GS77296 GS78395 GS78541 GS78543 GS80419 GS84016 GS66356 GS66358 GS66362 GS68611 GS68612 GS68613 GS68615 GS68618 GS68619 GS68623 GS68625 GS68626 GS68917 GS68918 GS68919 GS68920 GS70347 GS70394 GS70402 GS70403 GS70404 GS70405 GS70409 GS70413 GS70414 GS70415 GS70416 GS72559 GS72562 GS72563 GS72565 GS72917 GS72920 GS72921 GS72924 GS72933 GS72936 GS72938 GS73396 GS73452 GS73456 GS74918 GS74921 GS74922 GS75523 GS75526 GS75531 GS75532 GS75533 GS75534 GS77283 GS77295 GS77297 GS78394 GS78396 GS78404 GS78406 GS80417 GS66356 GS66358 GS66362 GS68612 GS68613 GS68615 GS68618 GS68619 GS68623 GS68625 GS68626 GS68917 GS68918 GS68919 GS68920 GS70347 GS70394 GS70402 GS70403 GS70404 GS70405 GS70409 GS70413 GS70414 GS70415 GS70416 GS72559 GS72562 GS72563 GS72565 GS72917 GS72920 GS72921 GS72924 GS72933 GS72936 GS72938 GS73396 GS73397 GS73452 GS73456 GS74918 GS74921 GS74922 GS75523 GS75526 GS75526 GS75531 GS75533 GS75534 GS77283 GS77295 GS77297 GS78394 GS78396 GS78404 GS78406 GS78555 GS80417 GS66356 GS68613 GS70414 ",,"179 units","Blood products, which exceeded time limits taken out of storage for labeling, were distributed.",8/19/2008,"08/19/2008",11/6/2013,"11/06/2013"
"Biologics",49155,"Terminated","Blood Bank of San Bernardino and Riverside Counties","San Bernardino","CA","US","Voluntary: Firm Initiated","Letter","California","B-2507-13","Class III","Platelets Pheresis Leukocytes Reduced Irradiated, Code: ILPAA","GS73397 GS75526 ",,"2 units","Blood products, which exceeded time limits taken out of storage for labeling, were distributed.",8/19/2008,"08/19/2008",11/6/2013,"11/06/2013"
"Biologics",49155,"Terminated","Blood Bank of San Bernardino and Riverside Counties","San Bernardino","CA","US","Voluntary: Firm Initiated","Letter","California","B-2509-13","Class III","Cryoprecipitated Reduced, Code: CRY","GN93464 GN96667 GN96700 GN96737 GN97580 GN97837 GN99456 GN99461 GN99464 GP00343 GP00355 GP00367 GP02213 GP02215 GP03171 GP03870 GP06177 GP06178 GP07347 GP07348 GP07925 GP07955 GP07982 GP09298 GP10343 GP10344 GP10660 GP11285 GP11497 GP12429 GP16144 GP16161 GP16176 GP16180 GP16188 GP16189 GP16194 GP16402 GP16633 GP16636 GP16659 GP16664 GP16671 GP16673 GP16679 GP16687 GP16689 GP16701 GP16712 GP16714 GP16726 GP16786 GP16799 GP16806 GP17382 GP17405 GP18518 GP18519 GP18522 GP18547 GP18549 GP20914 GP20922 GP20937 GP22386 GP22396 GP22686 GP22706 GS85943 GS85947 GS85969 GS87971 GS87972 GS87973 GS87977 GS87979 GS95309 GS95324 GX99180 GZ00077 GZ00111 GZ00710 GZ00975 GZ00982 GZ01977 GZ01985 GZ01988 GZ01990 GZ01996 GZ01997 GZ02009 GZ02013 GZ02026 GZ02028 GZ02040 GZ02268 GZ02273 GZ02302 GZ02315 GZ02317 GZ02321 GZ02323 GZ02330 GZ02331 GZ02341 GZ02351 GZ02574 GZ02578 GZ02586 GZ02591 GZ02602 GZ02612 GZ02928 GZ02929 GZ02937 GZ02942 GZ03004 GZ03005 GZ03011 GZ03012 GZ03018 GZ03030 GZ03053 GZ03055 GZ03057 GZ03069 GZ03075 GZ03299 GZ03301 GZ03303 GZ03304 GS62285 GS67560 ",,"133 units","Blood products, which exceeded time limits taken out of storage for labeling, were distributed.",8/19/2008,"08/19/2008",11/6/2013,"11/06/2013"
"Biologics",49155,"Terminated","Blood Bank of San Bernardino and Riverside Counties","San Bernardino","CA","US","Voluntary: Firm Initiated","Letter","California","B-2504-13","Class III","Red Blood Cells Leukocytes Reduced, codes: LRC6, LRC5, LRC3 ","GX94804 GW62803 GW62801 GX94808 GW62805 GX94803 GQ54219 GQ54221 GX94794 GX94799 GX94795 GX94790 GX94757 GX94758 GX94751 GX94760 GX94755 GX94763 GX94752 GX94767 GX94764 GX94768 GX94749 GX94761 GX94769 GX94754 GQ54034 GQ54017 GQ54016 Y96446 Y96451 GQ54217 Y96439 Y96442 Y96409 Y96422 Y96420 GY09002 GW79371 GW79385 GW79386 GW79382 GW79375 GW79376 GW79373 GY09002 GW79371 GW79385 GW79386 GW79382 GW79375 GW79376 GW79373 Y99056 Y99045 GC01624 GW79641 GW79640 GC01624 GW79641 GW79640 GN84524 GN84517 GN84526 GN84515 GN84529 GN84521 GN84525 GN84530 GN84520 GN84518 GN84522 GN84519 GN84523 GN84516 GQ54032 GQ54033 GQ54038 GQ54035 GQ54036 GQ54037 GQ54014 GQ54009 GQ54010 GQ54013 GQ54011 GQ54012 GN85176 GN85025 GN85180 GN85171 GN58184 GN85174 GN85181 GN85026 GN85024 GN85028 GN85029 GN85020 GC00015 GC00017 GP99721 GC00011 GP99719 GP99711 GP99714 GP99712 GP99707 GP99713 GP99709 GP99718 GP99706 GP99717 GP99720 GP99710 GP99708 GC00012 GC00007 GC00003 GC00010 GC00005 GC00004 GC00001 GC00008 GC00006 GC00009 GC00002 GC00965 GC00968 GC00961 GC00962 GC00963 GC00970 GC00972 GC00974 GC00966 GC00967 GW79365 GW79370 GW79367 GW79380 GW79377 GW79374 GW79378 GW79379 GC00015 GC00017 GP99721 GC00011 GP99719 GP99711 GP99714 GP99712 GP99707 GP99713 GP99709 GP99718 GP99706 GP99717 GP99720 GP99710 GP99708 GC00012 GC00007 GC00003 GC00010 GC00005 GC00004 GC00001 GC00008 GC00006 GC00009 GC00002 GC00971 GC00965 GC00968 GC00961 GC00962 GC00963 GC00970 GC00972 GC00974 GC00966 GC00967 GW79365 GW79367 GW79370 GW79380 GW79377 GW79374 GW79378 GW79379 GW65933 GW65996 GW65991 GQ57357 GW65988 GQ57355 GQ57356 GW65995 GQ57359 GQ57360 GW65992 GW65994 GW65989 GQ57358 GW65990 GP03563 GP03564 GP03571 GP03566 GP03578 GP03574 GX99640 GX99651 GX99641 GX99648 GX99649 GX99647 GP03514 GP03510 GP03513 GP03502 GP03507 GP03516 GP03503 GP03508 GP03534 GP03535 GP03547 GP03504 GP03506 GP03511 GP03509 GP03518 GP03505 GW79644 gc01621 GW79639 GC01625 GW79638 GW79643 GC00976 GC01623 GC01617 GC01622 GC01615 GC01616 GW79637 GC00975 GC00978 GC01620 GC01613 GC00977 GW79644 GC01621 GW7963"," GX95137 GX95139 GX95140 GX95141 GX95219 GX95222 GX95223 GX95228 GX95234 GX95236 GX95237 GX95241 GX95242 GX95243 GX95244 GX95342 GX95350 GX97382 GX97383 GX97387 GX97392 GX97395 GX97398 GX97421 GX98804 GX99124 GX99126 GX99127 GX99128 GX99129 GX99131 GX99133 GX99134 GX99135 GX99176 GX99177 GX99182 GX99183 GX99184 GX99186 GX99188 GX99192 GX99193 GX99195 GX99197 GX99199 GX99200 GX99201 GX99202 GX99205 GX99206 GX99207 GX99209 GX99211 GX99220 GX99222 GX99223 GX99233 GX99234 GX99236 GX99237 GX99238 GX99241 GX99243 GX99244 GX99245 GX99246 GX99623 GX99625 GX99630 GX99635 GX99636 GX99639 GX99815 GY07496 GY07498 GY07498 GY07499 GY07501 GY07502 GY07502 GY07504 GY07504 GY07505 GY07505 GY08264 GY08265 GY08266 GY08267 GY08268 GY08269 GY08270 GY08271 GY08272 GY08273 GY08274 GY08275 GY09923 GY09924 GY09926 GY09930 GY09935 GZ02323 GZ02325 GZ02326 GZ02328 GZ02346 GZ02348 GZ02349 GZ03246 GZ03247 GZ03248 GZ03249 GZ03250 GZ03252 GZ03253 GZ03254 GZ03255 GZ03256 GZ03298 GZ03299 GZ03300 GZ03301 GZ03303 GZ03304 GZ03306 GZ03307 GZ03312 GZ03313 GZ03314 GZ03315 GZ03316 GZ03319 GZ03320 GZ03328 GZ03329 GZ03331 GZ03332 GZ03333 GZ03334 GZ03335 GZ03336 GZ03337 GZ03339 GZ03340 GZ03341 GZ03342 GZ03343 GZ03344 GZ03345 GZ03346 GZ03347 GZ03348 GZ03349 GZ03351 GZ03353 GZ03355 GZ03356 GZ03358 GZ03359 GZ03360 GZ03361 GZ03362 GZ03363 GZ03364 GZ03365 GZ03366 GZ03367 GZ03368 GZ03369 GZ03371 GZ03372 GZ03373 GZ03376 GZ03377 GZ03378 GZ03379 GZ03484 GZ03485 GZ03486 GZ03488 GZ03489 GZ03491 GZ03493 GZ03494 GZ03495 GZ03498 GZ03499 GZ03501 GZ03522 GZ03653 GZ03728 GZ03729 GZ03730 GZ03731 GZ03732 GZ03742 GZ03743 GZ03745 GZ03748 GZ03749 GZ03750 GZ03751 GZ03752 GZ03753 GZ03755 GZ03756 GZ03757 GZ03759 GZ03860 GZ03861 GZ03862 GZ03863 GZ03865 GZ03956 GZ04019 GZ04020 GZ04021 GZ04022 GZ04023 GZ04026 GZ04027 GZ04028 GZ04029 GZ04031 GZ04032 GZ04034 GZ04035 GZ04036 GZ04037 GZ04038 GZ04039 GZ04040 GZ04041 GZ04043 GZ04044 GZ04045 GZ04188 GZ04189 GZ04190 GZ04191 GZ04192 GZ04193 GZ04194 GZ04195 GZ04196 GZ04199 GZ04202 GZ04203 GZ04204 GZ04206 GZ04207 GZ04208 GZ04210 GZ04211 GZ04","1 unit","Blood product, collected from an ineligible donor, was distributed. ",6/1/2013,"06/01/2013",11/6/2013,"11/06/2013"
"Biologics",49155,"Terminated","Blood Bank of San Bernardino and Riverside Counties","San Bernardino","CA","US","Voluntary: Firm Initiated","Letter","California","B-2504-13","Class III","Red Blood Cells, codes: RC6, RC6LV, RC5","GS95665 GS95670 GS95674 GS93565 GS93572 GS85540 GS85539 GS95665 GS95670 GS95674 GS93565 GS93572 GS85540 GS85539 GS93568 GS93566 GS93564 GS93567 GS95675 GS95673 GS93570 GS95678 GS93574 GS93573 GS95677 GS93838 GS93837 GS93568 GS93566 GS93834 GS93564 GS93567 GS95675 GS95673 GS93570 GS93569 GS95678 GS93574 GS93573 GS95677 GS93838 GS93837 GS93835 GS93569 GS93835 GS93571 GS93571 GS67306 GS50734 GS62284 GS62287 GS67344 GS67895 GS32722 GS32726 GS50725 GS50726 GS50727 GS50728 GS50729 GS62283 GS62285 GS62295 GS62355 GS67298 GS67300 GS67304 GS67336 GS67560 GS67562 GS67858 GS69377 GS69391 GS69394 GS74669 GS62286 ",,"76 units","Blood products, which exceeded time limits taken out of storage for labeling, were distributed.",8/19/2008,"08/19/2008",11/6/2013,"11/06/2013"
"Biologics",49158,"Terminated","Biomat USA, Inc.","Logan","UT","US","Voluntary: Firm Initiated","FAX","Austria","B-0325-13","Class II","Source Plasma","8160052763, 8160051047, 8160050780, 8160050356, 8160048823, 8160048574, 8160046973, 8160044948, 8160044626, 8160044266, 8160044047, 8160043643, 8160043634, 8160042902, 8160042819, 8160039198, 8160039056, 8160037466, 8160036624, 8160036207, 8160034821, 8160034135, 8160033992, 8160033693, 8160033432, 8160032439",".","26 units","Blood products, collected from a donor who received a tattoo within one year of donation, were distributed.",5/26/2008,"05/26/2008",1/16/2013,"01/16/2013"
"Biologics",49167,"Terminated","LifeServe Blood Center","Des Moines","IA","US","Voluntary: Firm Initiated","Letter","Iowa; Louisiana","B-0901-13","Class II","Red Blood Cells","LQ30802",".","1 Unit","Blood products, collected from a donor who reported travel to a malarial endemic area, were distributed",6/30/2008,"06/30/2008",4/10/2013,"04/10/2013"
"Biologics",49167,"Terminated","LifeServe Blood Center","Des Moines","IA","US","Voluntary: Firm Initiated","Letter","Iowa; Louisiana","B-0902-13","Class II","Red Blood Cells Leukocytes Reduced","GW23851",".","1 Unit","Blood products, collected from a donor who reported travel to a malarial endemic area, were distributed",6/30/2008,"06/30/2008",4/10/2013,"04/10/2013"
"Biologics",49169,"Terminated","Community Blood Center Of Gtr KC","Kansas City","MO","US","Voluntary: Firm Initiated","Letter","Missouri; Kansas; Iowa","B-0349-13","Class III","Platelets Pheresis Leukocytes Reduced","W045008906919; W045008904192; W045008904744; W045008906497; W045008906041; W045008906040; W045008905082; W045008907864; W045008907896; W045008905476",".","10 Units","Blood products, which may have been exposed to unacceptable temperatures during storage, were distributed.",7/9/2008,"07/09/2008",1/9/2013,"01/09/2013"
"Biologics",49180,"Terminated","American National Red Cross (The)","Pomona","CA","US","Voluntary: Firm Initiated","Telephone","California","B-1303-13","Class II","Plasma Frozen","06GF50381",".","1 unit","Blood products, collected from a donor for whom donor suitability was not adequately determined, were distributed.",6/6/2008,"06/06/2008",5/1/2013,"05/01/2013"
"Biologics",49180,"Terminated","American National Red Cross (The)","Pomona","CA","US","Voluntary: Firm Initiated","Telephone","California","B-1302-13","Class II","Red Blood Cells Leukocytes Reduced","06GF50381",".","1 unit","Blood products, collected from a donor for whom donor suitability was not adequately determined, were distributed.",6/6/2008,"06/06/2008",5/1/2013,"05/01/2013"
"Biologics",49181,"Terminated","BioLife Plasma Services LP","Independence","MO","US","Voluntary: Firm Initiated","FAX","CA","B-0072-13","Class III","Source Plasma","08IMOB1579; 08IMOA6642; 08IMOA3960",".","3 units","Blood product, collected from a donor whose suitability to donate was not adequately determined, was distributed.",5/29/2008,"05/29/2008",1/23/2013,"01/23/2013"
"Biologics",49196,"Terminated","The Blood Alliance, Inc.","Jacksonville","FL","US","Voluntary: Firm Initiated","Telephone","FL","B-1648-13","Class II","Red Blood Cells (Apheresis) Leukocytes Reduced","W118808610534-part A; W118808610534-part B; W118808610531-part A; W118808610531-part B",".","4 units","Blood products, which did not meet the acceptable product specifications, were distributed.",6/13/2008,"06/13/2008",7/10/2013,"07/10/2013"
"Biologics",49198,"Terminated","American Red Cross Blood Services","Saint Louis","MO","US","Voluntary: Firm Initiated","FAX","TX and MO","B-0609-13","Class II","Cryoprecipitated AHF","011GJ87885",".","1 unit","Blood products, collected from a donor whose suitability to donate was not adequately determined, were distributed. ",6/14/2008,"06/14/2008",2/27/2013,"02/27/2013"
"Biologics",49198,"Terminated","American Red Cross Blood Services","Saint Louis","MO","US","Voluntary: Firm Initiated","FAX","TX and MO","B-0608-13","Class II","Red Blood Cells","011GJ87885",".","1 unit","Blood products, collected from a donor whose suitability to donate was not adequately determined, were distributed. ",6/14/2008,"06/14/2008",2/27/2013,"02/27/2013"
"Biologics",49198,"Terminated","American Red Cross Blood Services","Saint Louis","MO","US","Voluntary: Firm Initiated","FAX","TX and MO","B-0607-13","Class III","Blood and Blood Products for Reprocessing","011GJ87885",".","1 unit","Blood products, collected from a donor whose suitability to donate was not adequately determined, were distributed. ",6/14/2008,"06/14/2008",2/27/2013,"02/27/2013"
"Biologics",49202,"Terminated","LifeServe Blood Center","Des Moines","IA","US","Voluntary: Firm Initiated","Letter","Iowa","B-0803-13","Class II","Platelets Pheresis Leukocytes Reduced","W037908113997",".","1 Unit","Blood product, which was labeled as leukoreduced, but was not tested to verify the White Blood Cell count, was distributed.",7/17/2008,"07/17/2008",3/27/2013,"03/27/2013"
"Biologics",49222,"Terminated","BioLife Plasma Service, LP","Van Nuys","CA","US","Voluntary: Firm Initiated","E-Mail","California","B-2152-13","Class II","Source Plasma","07KPT16024; 07KPT15990",".","2","Blood products which tested negative for all viral markers, were collected from a donor who subsequently tested positive for hepatitis C (HCV) by NAT.",8/19/2008,"08/19/2008",10/2/2013,"10/02/2013"
"Biologics",49228,"Terminated","American National Red Cross (The)","West Henrietta","NY","US","Voluntary: Firm Initiated","Letter","PA and NY","B-1292-13","Class III","Red Blood Cells Leukocytes Reduced","01LE52991; 01LV90232",".","2 units","Blood products, collected from a donor who traveled to a malarial and leishmaniasis endemic area, were distributed.",6/11/2008,"06/11/2008",7/10/2013,"07/10/2013"
"Biologics",49241,"Terminated","ZLB Bioplasma, Inc.","Tulsa","OK","US","Voluntary: Firm Initiated","FAX","Switzerland","B-0345-13","Class III","Source Plasma","0141396753, ",".","1 ","Blood product, which was collected from a donor in which donor suitability was not adequately determined, was distributed.",6/1/2008,"06/01/2008",1/9/2013,"01/09/2013"
"Biologics",49248,"Terminated","American Red Cross Blood Services","Saint Louis","MO","US","Voluntary: Firm Initiated","Letter","Missouri","B-2410-13","Class II","Red Blood Cells Leukocytes Reduced","011KJ13127 (2 units), 011KJ13201 (2 units)",,"4 units","Blood products, for which the quality control testing was not performed, were distributed.",6/27/2008,"06/27/2008",11/6/2013,"11/06/2013"
"Biologics",49253,"Terminated","Florida Blood Services, Inc.","St Petersburg","FL","US","Voluntary: Firm Initiated","FAX","Florida, Switzerland.","B-1057-13","Class II","Cryoprecipitate AHF","4411171",".","1 unit","Blood products, collected from a donor who provided a different last name, were distributed.",2/15/2008,"02/15/2008",5/15/2013,"05/15/2013"
"Biologics",49278,"Terminated","American National Red Cross (The)","West Henrietta","NY","US","Voluntary: Firm Initiated","Telephone","NY & PA","B-2167-13","Class III","Plasma Frozen within 24 hours (FP24)","01KG99436, 01KG99447, 01KG99458, 01KG99446, 01KG99460, 01KT32538, 01KT32537, 01KT32524, 01KT32522, 01KT32546, 01KT32541, 01KT32511, 01KT32553, 01KT32518, 01KT32530, 01GE72773, 01GE72771, 01GE72769, 01FM61970, 01FM61967, 01FM61966, 01FM61963, 01FM62201, 01FM62202, 01FM61961, 01FM61665, 01FM61972, 01FM61997, 01FM61998, 01FM62000, 01FM62205, 01FM61965, 01FM61968, 01GH15015, 01GH15014, 01GQ29463, 01GQ29461, 01GQ29467, 01GQ29469, 01GQ29451, 01GT29591, 1GT29612, 01GH15018 ",".","43","Blood products, for which West Nile Viral testing was incomplete, were distributed.",6/18/2008,"06/18/2008",10/2/2013,"10/02/2013"
"Biologics",49278,"Terminated","American National Red Cross (The)","West Henrietta","NY","US","Voluntary: Firm Initiated","Telephone","NY & PA","B-2165-13","Class III","Red Blood Cells Leukocytes Reduced Irradiated","01GT29616 , 01GT29611 , 01GT29462 , 01GT29617 , 01GT29607, 01GQ29457",".","6","Blood products, for which West Nile Viral testing was incomplete, were distributed.",6/18/2008,"06/18/2008",10/2/2013,"10/02/2013"
"Biologics",49278,"Terminated","American National Red Cross (The)","West Henrietta","NY","US","Voluntary: Firm Initiated","Telephone","NY & PA","B-2166-13","Class III","Platelets Leukocytes Reduced","01W51941",".","1","Blood products, for which West Nile Viral testing was incomplete, were distributed.",6/18/2008,"06/18/2008",10/2/2013,"10/02/2013"
"Biologics",49278,"Terminated","American National Red Cross (The)","West Henrietta","NY","US","Voluntary: Firm Initiated","Telephone","NY & PA","B-2164-13","Class III","Red Blood Cells (Apheresis) Leukocytes Reduced ","01GQ29427 bag1 & bag2, 01GQ29429 bag 1 & bag2, 01GQ29430 bag2 , 01KG99421 bag1, 01KG99425 bag1, 01KG99422 bag1, 01KG99420 bag1, 01KG99423 bag1 & bag2, 01KG99424 bag 1 & bag 2, 01GQ29434 bag1, 01GQ29426 bag1 & bag2, 01GQ29435 bag1, and 01GQ29436 bag1",".","18","Blood products, for which West Nile Viral testing was incomplete, were distributed.",6/18/2008,"06/18/2008",10/2/2013,"10/02/2013"
"Biologics",49278,"Terminated","American National Red Cross (The)","West Henrietta","NY","US","Voluntary: Firm Initiated","Telephone","NY & PA","B-2162-13","Class III","Red Blood Cells","01KG99432, 01KG99431, 01KG99434, 01KG99435, 01KG99438, 01KG99460, 01KG99447, 01KG99445, 01KG99458, 01KG99453, 01KG99457, 01KG99451, 01KG99441, 01KG99456, 01KG99433, 01KG99436, 01GE72762, 01GE72764, 01GE72763, 01FM61959;01FM61955;01FM61962;01FM61968;01FM61970;01FM61960;01FM61963;01FM61965;01FM61966;01FM61971;01FM61972",".","30","Blood products, for which the West Nile Viral testing performed was incomplete, were distributed.",6/18/2008,"06/18/2008",10/2/2013,"10/02/2013"
"Biologics",49278,"Terminated","American National Red Cross (The)","West Henrietta","NY","US","Voluntary: Firm Initiated","Telephone","NY & PA","B-2163-13","Class III","Red Blood Leukocytes Reduced ","01GH15013, 01GH15012, 01GQ29464, 01GQ29427, 01GQ29454, 1GQ29460, 01GQ29461, 01GQ29463, 01GQ29465, 01GQ29467, 01GQ29469, 1GQ29474, 01GQ29453, 01GQ29458, 01GQ29468, 01KT32514, 01KT32524, 01KT32520, 01KT32524, 01KT32539, 01KT32530, 01KT32546, 01KT32536, 01KT32538, 01KT32543, 01KT32547, 01KT32541, 01KT325519, 01KT32544, 01KT32521, 01KT32528, 01KT32532, 01KT32522, 01FM62000, 01FM61998, 01GE72771, 01GT29616, 01GT29609, 01GT29610, 01GT29613, 01GT29614, 01GT29615, 01GT29590, 01KM53768, 01KM53770, 01KM53766, 01KM53776, 01KM53761, 01KM53764, 01KM53765, 01KM53775, 01KM53791, 01KM53774, 01KM53767, 01KM53769, 01KM53762 01KJ89623 ",".","57","Blood products, for which West Nile Viral testing was incomplete, were distributed.",6/18/2008,"06/18/2008",10/2/2013,"10/02/2013"
"Biologics",49288,"Terminated","American National Red Cross (The)","Tucson","AZ","US","Voluntary: Firm Initiated","Telephone","AZ","B-2467-13","Class II","Red Blood Cells Leukocytes Reduced","07FQ48267",,"1 unit","Blood product, collected from a donor who traveled to an area considered endemic for malaria, was distributed.",7/3/2008,"07/03/2008",11/6/2013,"11/06/2013"
"Biologics",49299,"Terminated","Suncoast Communities Blood Bank, Inc.","Sarasota","FL","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","FL, MA, TN, NJ, KY, Puerto Rico","B-1418-13","Class II","Red Blood Cells Leukocytes Reduced","2224423; 2225130; 2225141; 2227075; 2227109; 2227113; 2227117; 2227120; 2227122; 2227132; 2227137; 2227140; 2227144; 2227149; 2227169; 2227176; 2227182; 2227189; 2228139; 2228145; 2228262; 2228277; 2228340; 2228345; 2228351; 2228360; 2228376; 2228389; 2229533; 2229570; 2229572; 2229574; 2229579; 2229584; 2230026; 2230411; 2230431; 2230433; 2230440; 2230653; 2230661; 2230664; 2230723; 2230729; 2230733; 2230769; 2230772; 2230773; 2230777; 2230779; 2230943; 2230950; 2231218; 2231222; 2231299; 2231303; 2231304; 2231310; 2231312; 2231314; 2231315; 2231316; 2231318; 2231320; 2231331; 2231335; 2231342; 2231347; 2231354; 2231359; 2231401; 2232373; 2232774; 2232779; 2232786; 2232788; 2232789; 2232791; 2232793; 2232796; 2232798; 2232839; 2232842; 2232858; 2232861; 2232865; 2232870; 2232876; 2232878; 2232880; 2232893; 2232906; 2232909; W038608280184; W038608280210; W038608280242; W038608280251; W038608280336; W038608280350; W038608280355; W038608280365; W038608280405; W038608280406; W038608280408; W038608280409; W038608280412; W038608280413; W038608280441; W038608280454; W038608280564; W038608280571; W038608280573; W038608280579; W038608280583; W038608280586; W038608280589; W038608280780; W038608281602; W038608281620; W038608281636; W038608281656; W038608281657; W038608281670; W038608281698; W038608281701; W038608281703; W038608281800; W038608281801; W038608281862; W038608281875; W038608281881; W038608282225; W038608282247; W038608282248; W038608282876; W038608282878; W038608282887; W038608880850; W038608881040; W038608881044. ",".","140","Blood products, which were collected from a donor in which donor suitability was not adequately determined, were distributed.",6/21/2008,"06/21/2008",6/19/2013,"06/19/2013"
"Biologics",49299,"Terminated","Suncoast Communities Blood Bank, Inc.","Sarasota","FL","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","FL, MA, TN, NJ, KY, Puerto Rico","B-1417-13","Class II","Red Blood Cells (Apheresis) Leukocytes Reduced","2224421; 2227153; 2228344; 2228348; 2229556; 2230421; 2230651; 2231443; 2232849; 2232854; 2232887; 2232910; W038608280358; W038608280420; W038608280456; W038608280581; W038608280672; W038608281606; W038608281612; W038608281891; W038608281922; W038608282360; W038608282666; W038608880242; W038608881051. ",".","25 units","Blood products, which were collected from a donor in which donor suitability was not adequately determined, were distributed.",6/21/2008,"06/21/2008",6/19/2013,"06/19/2013"
"Biologics",49299,"Terminated","Suncoast Communities Blood Bank, Inc.","Sarasota","FL","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","FL, MA, TN, NJ, KY, Puerto Rico","B-1416-13","Class II","Fresh Frozen Plasma ","2224422; 2227113; 2227117; 2227152; 2228255; 2228256; 2228340; 2228345; 2228349; 2229530; 2229532; 2229533; 2229554; 2229579; 2229582; 2230411; 2230433; 2230656; 2230777; 2230779; 2230943; 2231222; 2231297; 2231314; 2231318; 2231320; 2231331; 2231334; 2232781; 2232789; 2232791; 2232793; 2232835; 2232837; 2232842; 2232843; 2232846; 2232853; 2232861; 2232868; 2232876; 2232893; 2232900; 2232909; 8814339; 8814344; W038608280210; W038608280338; W038608280340; W038608280342; W038608280365; W038608280405; W038608280441; W038608280450; W038608280455; W038608280457; W038608280482; W038608280566; W038608280568; W038608280573; W038608280582; W038608280586; W038608280762; W038608280765; W038608280866; W038608280913; W038608281335; W038608281620; W038608281661; W038608281666; W038608281670; W038608281698; W038608281701; W038608281703; W038608281710; W038608281757; W038608281795; W038608281910; W038608281916; W038608282225; W038608282248; W038608282617; W038608282629; W038608282661; W038608282665; W038608880862; W038608881040; W038608881044; W038608881813; W038608881815; W038608881817; W038608881822. ",".","92 units","Blood products, which were collected from a donor in which donor suitability was not adequately determined, were distributed.",6/21/2008,"06/21/2008",6/19/2013,"06/19/2013"
"Biologics",49299,"Terminated","Suncoast Communities Blood Bank, Inc.","Sarasota","FL","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","FL, MA, TN, NJ, KY, Puerto Rico","B-1420-13","Class II","Fresh Frozen Plasma (Apheresis)","8814559; W038608880648.",".","2 units","Blood products, which were collected from a donor in which donor suitability was not adequately determined, were distributed.",6/21/2008,"06/21/2008",6/19/2013,"06/19/2013"
"Biologics",49299,"Terminated","Suncoast Communities Blood Bank, Inc.","Sarasota","FL","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","FL, MA, TN, NJ, KY, Puerto Rico","B-1421-13","Class III","Blood and Blood Products for Reprocessing","2224423; 2224424; 2224425; 2224427;2225130; 2225134; 2225137; 2225139; 2225174; 2227075; 2227106; 2227109; 2227116; 2227120; 2227122; 2227127; 2227132; 2227137; 2227140; 2227144; 2227149; 2227169; 2227176; 2227182; 2227189; 2228116; 2228139; 2228145; 2228150; 2228152; 2228239; 2228262; 2228277; 2228285; 2228342; 2228351; 2228352; 2228360; 2228364; 2228366; 2228367; 2228376; 2228377; 2228381; 2228384; 2228387; 2228389; 2229535; 2229552; 2229559; 2229564; 2229568; 2229570; 2229572; 2229574; 2229584; 2230026; 2230415; 2230423; 2230431; 2230437; 2230439; 2230440; 2230476; 2230477; 2230480; 2230485; 2230490; 2230578; 2230582; 2230590; 2230595; 2230597; 2230599; 2230600; 2230653; 2230661; 2230664; 2230723; 2230725; 2230727; 2230729; 2230731; 2230733; 2230765; 2230769; 2230772; 2230773; 2230776; 2230896; 2230950; 2231207; 2231211; 2231218; 2231299; 2231301; 2231303; 2231304; 2231310; 2231312; 2231315; 2231316; 2231322; 2231327; 2231329; 2231335; 2231342; 2231347; 2231354; 2231358; 2231359; 2231376; 2231377; 2231382; 2231384; 2231388; 2231394; 2231396; 2231397; 2231401; 2231407; 2231411; 2231413; 2231417; 2231420; 2231422; 2231423; 2231424; 2231425; 2231427; 2231429; 2231431; 2231434; 2231436; 2231440; 2231441; 2231442; 2231444; 2231446; 2231447; 2231448; 2231450; 2232113; 2232774; 2232779; 2232786; 2232788; 2232796; 2232798; 2232801; 2232839; 2232841; 2232858; 2232863; 2232865; 2232870; 2232878; 2232880; 2232883; 2232885; 2232888; 2232892; 2232904; 2232906; 2233005; 2233007; 2233054; 2233060; 2233061; W038608280167; W038608280172; W038608280175; W038608280177; W038608280182; W038608280184; W038608280214; W038608280218; W038608280221; W038608280241; W038608280242; W038608280247; W038608280251; W038608280253; W038608280255; W038608280256; W038608280257; W038608280261; W038608280262; W038608280265; W038608280266; W038608280268; W038608280270; W038608280271; W038608280273; W038608280276; W038608280336; W038608280350; W038608280355; W038608280388; W038608280390; W038608280391; W038608280393; W038608280402; W038608280403",".","262 units","Blood products, which were collected from a donor in which donor suitability was not adequately determined, were distributed.",6/21/2008,"06/21/2008",6/19/2013,"06/19/2013"
"Biologics",49299,"Terminated","Suncoast Communities Blood Bank, Inc.","Sarasota","FL","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","FL, MA, TN, NJ, KY, Puerto Rico","B-1415-13","Class II","Red Blood Cells","2224422; 2224424; 2224425; 2224427; 2225134; 2225137; 2225139; 2225174; 2227106; 2227116; 2227127; 2227152; 2228116; 2228150; 2228152; 2228239; 2228255; 2228256; 2228285; 2228342; 2228349; 2228352; 2228364; 2228366; 2228367; 2228377; 2228381; 2228384; 2228387; 2229530; 2229532; 2229535; 2229552; 2229554; 2229559; 2229564; 2229568; 2229582; 2230415; 2230423; 2230437; 2230439; 2230476; 2230477; 2230479; 2230480; 2230485; 2230487; 2230490; 2230578; 2230582; 2230590; 2230595; 2230597; 2230599; 2230600; 2230656; 2230725; 2230727; 2230731; 2230765; 2230776; 2230896; 2231207; 2231211; 2231297; 2231301; 2231322; 2231327; 2231329; 2231334; 2231358; 2231376; 2231377; 2231382; 2231384; 2231388; 2231394; 2231396; 2231397; 2231407; 2231411; 2231413; 2231417; 2231420; 2231422; 2231423; 2231424; 2231425; 2231427; 2231429; 2231431; 2231434; 2231436; 2231440; 2231441; 2231442; 2231444; 2231446; 2231447; 2231448; 2231450; 2232113; 2232781; 2232801; 2232835; 2232837; 2232841; 2232843; 2232846; 2232853; 2232863; 2232868; 2232883; 2232885; 2232888; 2232892; 2232900; 2232904; 2233005; 2233007; 2233054; 2233060; 2233061; 8814339; 88114344; W038608280167; W038608280172; W038608280175; W038608280177; W038608280182; W038608280214; W038608280218; W038608280221; W038608280241; W038608280247; W038608280253; W038608280255; W038608280256; W038608280257; W038608280261; W038608280262; W038608280265; W038608280266; W038608280268; W038608280270; W038608280271; W038608280273; W038608280276; W038608280338; W038608280340; W038608280342; W038608280388; W038608280390; W038608280391; W038608280393; W038608280402; W038608280403; W038608280415; W038608280418; W038608280421; W038608280450; W038608280455; W038608280457; W038608280462; W038608280482; W038608280566; W038608280568; W038608280578; W038608280582; W038608280667; W038608280668; W038608280759; W038608280760; W038608280762; W038608280765; W038608280784; W038608280786; W038608280792; W038608280859; W038608280861; W038608280862; W038608280866; W038608280913; W038608281321; W038608281323; W038608281",".","242 units","Blood products, which were collected from a donor in which donor suitability was not adequately determined, were distributed.",6/21/2008,"06/21/2008",6/19/2013,"06/19/2013"
"Biologics",49299,"Terminated","Suncoast Communities Blood Bank, Inc.","Sarasota","FL","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","FL, MA, TN, NJ, KY, Puerto Rico","B-1419-13","Class II","Platelets Pheresis Leukocytes Reduced","8814517; 8814559; W038608880648. ",".","3 units","Blood products, which were collected from a donor in which donor suitability was not adequately determined, were distributed.",6/21/2008,"06/21/2008",6/19/2013,"06/19/2013"
"Biologics",49317,"Terminated","Southern California Permanente Medical Group Blood Donor Center","Irvine","CA","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","CA","B-1790-13","Class II","Red Blood Cells","W071808005080",".","1 unit","Blood product, which was collected from a donor who traveled to a malarial endemic area, was distributed. ",8/4/2008,"08/04/2008",7/17/2013,"07/17/2013"
"Biologics",49326,"Terminated","American National Red Cross","Portland","OR","US","Voluntary: Firm Initiated","Letter","California.","B-0168-13","Class II","Platelets Pheresis Leukocytes Reduced Irradiated","21KT41666; 21KT41666",".","2 components","Blood products, labeled as leukoreduced without the assurance that they met the criteria for leukoreduced products, were distributed.",7/2/2008,"07/02/2008",1/23/2013,"01/23/2013"
"Biologics",49339,"Terminated","Upstate New York Transplant Services","Buffalo","NY","US","Voluntary: Firm Initiated","Telephone","New York and New Jersey","B-1506-13","Class III","Red Blood Cells Leukocytes Reduced","2004692",".","1 component ","Blood products, collected from donors whose hematocrits were determined using an analyzer with an invalid QC control, were distributed.",8/8/2008,"08/08/2008",5/15/2013,"05/15/2013"
"Devices",49516,"Terminated","Ventana Medical Systems Inc","Tucson","AZ","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution - USA Nationwide and the countries of Canada, Europe, Asia, Japan.","Z-2118-2013","Class II","Benchmark XT/LT and Discovery XT Model Numbers: N750-BMK-FS, N750-BMKXT-FS, N750-BMKLT-FS, N750-DIS-FS, N750-DISXT-FS. Product Usage: Usage: The Benchmark product lines are intended to automatically stain histological or cytological specimens on microscope slides with specific immunohistochemistry or in situ hybridization reagents for in vitro diagnostic use. The Discovery Systems are research use only instruments with similar functionality. ","BenchMark XT Instruments-S/N: 711869-712465; BenchMark LT instruments-S/N: 610321-610345. Discovery XT Instruments-S/N: 610321-610345.",,"1217 units total","Ventana Medical System is initiating the recall of the BenchMark and DISCOVERY series instruments because there is a possibility that the heating element could separate from the underside of the heater cap and cause a non-staining or inconsistent staining event. Additionally, the system may not detect this anomaly and therefore it may not generate an error message for the slide position.",6/12/2008,"06/12/2008",9/4/2013,"09/04/2013"
"Biologics",49615,"Terminated","Puget Sound Blood Center","Seattle","WA","US","Voluntary: Firm Initiated","Letter","Washington.","B-0488-13","Class II","Red Blood Cells Leukocytes Reduced","W141608134016; W141608530989.",".","2 components","Blood products, collected from a donor who traveled to a malaria risk area, were distributed.",8/13/2008,"08/13/2008",4/24/2013,"04/24/2013"
"Biologics",49615,"Terminated","Puget Sound Blood Center","Seattle","WA","US","Voluntary: Firm Initiated","Letter","Washington.","B-0489-13","Class II","Platelets Pooled Leukocytes Reduced Irradiated","W141608530989.",".","1 component","Blood products, collected from a donor who traveled to a malaria risk area, were distributed.",8/13/2008,"08/13/2008",4/24/2013,"04/24/2013"
"Biologics",49622,"Terminated","Southern California Permanente Medical Group Blood Donor Center","Irvine","CA","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","CA","B-1677-13","Class II","Red Blood Cells","GE40780; GJ43610",,"2 units","Blood products, which were collected from a donor who traveled to a malarial endemic area, were distributed. ",8/5/2008,"08/05/2008",8/7/2013,"08/07/2013"
"Biologics",49628,"Terminated","Talecris Plasma Resources, Inc.","Research Triangle Park","NC","US","Voluntary: Firm Initiated","FAX","North Carolina.","B-1105-13","Class II","Source Plasma","367094508, 367093944, 367095063",,"3 Components","Blood products, which were not tested for viral markers, were distributed.",2/26/2008,"02/26/2008",5/8/2013,"05/08/2013"
"Biologics",49633,"Terminated","Florida's Blood Centers, Inc.","Orlando","FL","US","Voluntary: Firm Initiated","E-Mail","Austria.","B-1056-13","Class II","Blood and Blood Products for Reprocessing Recovered Plasma Cryoprecipitate Reduced.","5699436",".","1 unit","Blood products, which were collected from an unsuitable donor based on risk factors for variant Creutzfeldt-Jakob Disease (vCJD), were distributed.",7/8/2008,"07/08/2008",5/15/2013,"05/15/2013"
"Biologics",49635,"Terminated","Mississippi Valley Reg Bld Ctr","Davenport","IA","US","Voluntary: Firm Initiated","FAX","IA, MO, NJ","B-0697-13","Class III","Platelets Pheresis Leukocytes Reduced","W038308001621(part 1); W038308001622 (part 1); W038308001621(part 2); W038308001622 (part 2)",".","4 units","Blood products, held in transit storage container for 24 hours and possibly exposed to unacceptable temperatures, were distributed. ",7/21/2008,"07/21/2008",3/27/2013,"03/27/2013"
"Biologics",49635,"Terminated","Mississippi Valley Reg Bld Ctr","Davenport","IA","US","Voluntary: Firm Initiated","FAX","IA, MO, NJ","B-0696-13","Class III","Red Blood Cells Leukocytes Reduced","W038308070193; W038308070195; W038308072208; W038308072210; W038308072212; W038308072213; W038308072214; W038308072216; W038308072217; W038308072219; W038308072220; W038308072221; W038308072222; W038308072226",".","14 units","Blood products, held in transit storage container for 24 hours and possibly exposed to unacceptable temperatures, were distributed. ",7/21/2008,"07/21/2008",3/27/2013,"03/27/2013"
"Biologics",49684,"Terminated","American National Red Cross (The)","Little Rock","AR","US","Voluntary: Firm Initiated","Telephone","AR","B-0341-13","Class II","Red Blood Cells Leukocytes Reduced","55C41646;55C38742;55C36864",".","3 components","Blood products, which were collected from a donor who traveled to a malarial endemic area, were distributed.",7/21/2008,"07/21/2008",1/9/2013,"01/09/2013"
"Biologics",49698,"Terminated","Blood Bank of San Bernardino and Riverside Counties","San Bernardino","CA","US","Voluntary: Firm Initiated","Letter","California","B-1806-13","Class II","Red Blood Cells Leukocytes Reduced","GN91057",".","1 unit","Blood product, collected from a donor with a history of Hepatitis A, was distributed.",8/26/2008,"08/26/2008",7/17/2013,"07/17/2013"
"Biologics",49703,"Terminated","Puget Sound Blood Center and Program","Seattle","WA","US","Voluntary: Firm Initiated","Letter","California.","B-0487-13","Class II","Red Blood Cells Leukocytes Reduced","W141608213448",".","1 component","Blood product, which was collected from a donor who traveled to a malarial endemic area, was distributed.",7/23/2008,"07/23/2008",2/6/2013,"02/06/2013"
"Biologics",49706,"Terminated","Mississippi Valley Reg Bld Ctr","Davenport","IA","US","Voluntary: Firm Initiated","FAX","IA, Switzerland","B-0095-13","Class III","Red Blood Cells Leukocytes Reduced","W038308023614",".","1 unit","Blood product, manufactured without the entire quantity of additive solution, was distributed.",8/5/2008,"08/05/2008",3/27/2013,"03/27/2013"
"Biologics",49719,"Terminated","Puget Sound Blood Center and Program","Seattle","WA","US","Voluntary: Firm Initiated","Letter","Washington.","B-0490-13","Class II","Red Blood Cells","W141608630171.",".","1 component","Blood product, which was collected from a donor who traveled to a malarial endemic area, was distributed.",8/25/2008,"08/25/2008",2/6/2013,"02/06/2013"
"Biologics",49720,"Terminated","American Red Cross Blood Services","Saint Louis","MO","US","Voluntary: Firm Initiated","Letter","Missouri; Texas","B-0184-13","Class III","Blood and Blood Products for Reprocessing","011FX17525",".","1 Unit","Blood products, collected from a donor whose suitability to donate was not adequately determined, were distributed.",7/15/2008,"07/15/2008",1/23/2013,"01/23/2013"
"Biologics",49720,"Terminated","American Red Cross Blood Services","Saint Louis","MO","US","Voluntary: Firm Initiated","Letter","Missouri; Texas","B-0182-13","Class II","Red Blood Cells Leukocytes Reduced","011GT77158; 011FX17525",".","2 Units","Blood products, collected from a donor whose suitability to donate was not adequately determined, were distributed.",7/15/2008,"07/15/2008",1/23/2013,"01/23/2013"
"Biologics",49720,"Terminated","American Red Cross Blood Services","Saint Louis","MO","US","Voluntary: Firm Initiated","Letter","Missouri; Texas","B-0183-13","Class II","Plasma Frozen","011GT77158",".","1 Unit","Blood products, collected from a donor whose suitability to donate was not adequately determined, were distributed.",7/15/2008,"07/15/2008",1/23/2013,"01/23/2013"
"Biologics",49741,"Terminated","Talecris Plasma Resources, Inc.","Colorado Springs","CO","US","Voluntary: Firm Initiated","Telephone","NC","B-1286-13","Class III","Source Plasma","033107151A; 033108101; 033108102; 033108103; 033108104; 033108105; 033108106; 033108108; 033108109; 033108107",".","10 vender batches","Blood products, which reached unacceptable temperatures during storage, were distributed.",4/9/2008,"04/09/2008",7/10/2013,"07/10/2013"
"Biologics",49757,"Terminated","Suncoast Communities Blood Bank, Inc.","Sarasota","FL","US","Voluntary: Firm Initiated","FAX","FL","B-1162-13","Class III","Red Blood Cells","W038608281767",".","1 unit","Blood product, collected from a donor with no documentation of an arm inspection, was distributed.",8/4/2008,"08/04/2008",5/29/2013,"05/29/2013"
"Biologics",49757,"Terminated","Suncoast Communities Blood Bank, Inc.","Sarasota","FL","US","Voluntary: Firm Initiated","FAX","FL","B-1163-13","Class III","Fresh Frozen Plasma ","W038608281767",".","1 unit","Blood product, collected from a donor with no documentation of an arm inspection, was distributed.",8/4/2008,"08/04/2008",5/29/2013,"05/29/2013"
"Biologics",49760,"Terminated","BioLife Plasma Services LP","Independence","MO","US","Voluntary: Firm Initiated","E-Mail","California","B-1026-13","Class III","Source Plasma","07IMOG3145;07IMOG3633;07IMOG4399;07IMOG5428; 07IMOG7544;07IMOG8065;07IMOG9727;08IMOA1536; 08IMOA2184;08IMOA3310;08IMOA3940;08IMOA5130; 08IMOA5775;08IMOA6926;08IMOA7545;08IMOA8600; 08IMOA9170;08IMOB0195;08IMOB0120;08IMOB1852; 08IMOB2406;08IMOB3476;08IMOB4110;08IMOB6915; 08IMOB7535;08IMOB8596;08IMOB9162;08IMOC0356; 08IMOC1016;08IMOC2529;08IMOC3217;08IMOC4380; 08IMOC5073;08IMOC6209;08IMOC6880;08IMOC9283; 08IMOC9918;08IMOD1004;08IMOD1628;08IMOD2715; 08IMOD3403",,"41 Units","Blood products, collected from donors for whom donor suitability was not adequately determined, were distributed.",7/18/2008,"07/18/2008",5/8/2013,"05/08/2013"
"Biologics",49793,"Terminated","American National Red Cross (The)","Cleveland","OH","US","Voluntary: Firm Initiated","Telephone","OH, NJ, GA, MO, NC, MI, SC, IN, and CA","B-0531-13","Class II","Red Blood Cells Leukocytes Reduced Irradiated","006FE32995",,"1 unit","Blood products, collected in a manner that may have compromised the sterility of the collection system, were distributed.",8/7/2008,"08/07/2008",3/13/2013,"03/13/2013"
"Biologics",49793,"Terminated","American National Red Cross (The)","Cleveland","OH","US","Voluntary: Firm Initiated","Telephone","OH, NJ, GA, MO, NC, MI, SC, IN, and CA","B-0530-13","Class II","Cryoprecipitate AHF, Pooled","006L16589",,"1 unit","Blood products, collected in a manner that may have compromised the sterility of the collection system, were distributed.",8/7/2008,"08/07/2008",3/13/2013,"03/13/2013"
"Biologics",49793,"Terminated","American National Red Cross (The)","Cleveland","OH","US","Voluntary: Firm Initiated","Telephone","OH, NJ, GA, MO, NC, MI, SC, IN, and CA","B-0528-13","Class II","Plasma Frozen","42FE10144; 42FG38596; 42GX05663; 42CX05665; 42L54010 ",,"5 units","Blood products, collected in a manner that may have compromised the sterility of the collection system, were distributed. ",8/7/2008,"08/07/2008",3/13/2013,"03/13/2013"
"Biologics",49793,"Terminated","American National Red Cross (The)","Cleveland","OH","US","Voluntary: Firm Initiated","Telephone","OH, NJ, GA, MO, NC, MI, SC, IN, and CA","B-0532-13","Class II","Plasma Frozen within 24 hours after Phlebotomy (FP24)","42FZ62526; 42FG38596; 42FZ31978; 006LV50504; 006LV50477; 006LH16787; 006FY92533; 006LT83833; 006FY93230; 006GV77545; 006GE03248; 006FC59791; 006FC59790; 006GX88824; 006GX88853; 006FE31590; 006FE31591; 006GX88583; 006FR07331; 006FR07309; 006FY91374; 006GX88558; 006FY91468; 006LT84124; 006FY91564; 006FY83209; 006LS18607; 006GP95732; 006FE32997; 006FC60183; 006LH16761; 006LQ04205; 006LT84139; 006FY92525; 006FR07284; 006GT77323; 006GW55916; 006LP45234; 006GE34230; 006FY93228; 006GT77327; 006FC60177; 006LT84391; 006FY92828; 006LT84147; 006LP43762; 006FR07279; 006FY91552; 006FY91461; 006FY91322; 006FE30810; 006GT76431; 006GL03267; 006FY91566",,"54 units","Blood products, collected in a manner that may have compromised the sterility of the collection system, were distributed.",8/7/2008,"08/07/2008",3/13/2013,"03/13/2013"
"Biologics",49793,"Terminated","American National Red Cross (The)","Cleveland","OH","US","Voluntary: Firm Initiated","Telephone","OH, NJ, GA, MO, NC, MI, SC, IN, and CA","B-0529-13","Class II","Red Blood Cells","42FG38734",,"1 unit","Blood products, collected in a manner that may have compromised the sterility of the collection system, were distributed.",8/7/2008,"08/07/2008",3/13/2013,"03/13/2013"
"Biologics",49793,"Terminated","American National Red Cross (The)","Cleveland","OH","US","Voluntary: Firm Initiated","Telephone","OH, NJ, GA, MO, NC, MI, SC, IN, and CA","B-0527-13","Class II","Red Blood Cells Leukocytes Reduced","42FE10146; 42FG38598; 42L54257; 42GX05663; 42GS32747; 42FE10012; 42FE10015; 42FE10144; 42FE10145; 42FE10019; 42FE10140; 42FE10148; 42FG38588; 42FG38596; 42FY87647; 42GX05665; 42L54010; 42L54256; 006LV50469; 006LP45246; 006FY93535; 006GS40395; 006LH17884; 006GT77083; 006GE34211; 006LV50477; 006LP45421; 006LQ04192; 006LV50512; 006LV50488; 006LV50506; 006LH17880; 006LY83121; 006LY83089; 006LY83117; 42FE10019; 42FE10140; 42FE10148; 42FG38588; 42FG38596; 006FY92834; 006FC59395; 42FW52035; 42FG38596; 42FG38597;42M35638; 42GT24395; 42GS33656; 42GM06234; 42GM06237; 42GM06238; 42W53470; 42GM06233; 42M35638; 006FE32665; 006GV77287; 42FY81647; 42GX05665; 42L54010; 42L54256",,"51 units","Blood products, collected in a manner that may have compromised the sterility of the collection system, were distributed. ",8/7/2008,"08/07/2008",3/13/2013,"03/13/2013"
"Biologics",49806,"Terminated","LifeSouth Community Blood Centers","Lecanto","FL","US","Voluntary: Firm Initiated","FAX","FL","B-1161-13","Class II","Platelets Pheresis Leukocytes Reduced","72H259365",".","1 unit","Blood product, with a low platelet count, was distributed.",7/24/2008,"07/24/2008",5/29/2013,"05/29/2013"
"Biologics",49812,"Terminated","Southern California Permanente Medical Group Blood Donor Center","Irvine","CA","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","CA","B-1791-13","Class II","Platelets Pheresis Leukocytes Reduced","W07180800087",".","1 unit","Blood product, which did not meet the acceptable product specifications for release, was distributed. ",9/2/2008,"09/02/2008",7/17/2013,"07/17/2013"
"Biologics",49814,"Terminated","Puget Sound Blood Center and Program","Seattle","WA","US","Voluntary: Firm Initiated","Letter","Austria.","B-0491-13","Class III","Blood and Blood Products for Reprocessing","W141608007333",".","1 component","Blood product, which was collected from a donor who was taking the medication Finasteride, was distributed.",8/25/2008,"08/25/2008",2/6/2013,"02/06/2013"
"Biologics",49819,"Terminated","Puget Sound Blood Center and Program","Seattle","WA","US","Voluntary: Firm Initiated","Letter","California.","B-0544-13","Class II","Red Blood Cells Leukocytes Reduced","W141608213600",,"1 component","Blood product, which was collected from a donor who was taking the medication Finasteride, was distributed.",8/12/2008,"08/12/2008",3/6/2013,"03/06/2013"
"Biologics",49820,"Terminated","Puget Sound Blood Center and Program","Seattle","WA","US","Voluntary: Firm Initiated","FAX","Austria.","B-0545-13","Class II","Blood and Blood Products for Reprocessing","R305763",,"1 component","Blood products, collected from a donor who was at risk for variant Creutzfeldt-Jakob disease (vCJD), were distributed.",8/25/2008,"08/25/2008",3/6/2013,"03/06/2013"
"Biologics",49821,"Terminated","Puget Sound Blood Center and Program","Seattle","WA","US","Voluntary: Firm Initiated","FAX","Washington.","B-0547-13","Class II","Platelets","W141608415198",,"1 component","Blood product, which was collected from a donor in whom donor suitability was not adequately determined, was distributed.",7/29/2008,"07/29/2008",3/6/2013,"03/06/2013"
"Biologics",49827,"Terminated","The Blood Alliance, Inc.","Jacksonville","FL","US","Voluntary: Firm Initiated","FAX","FL, MO","B-1687-13","Class II","Fresh Frozen Plasma","W118808540372; 3629542",".","2 units","Blood products, collected from a donor with a history of high risk behavior, was distributed.",8/4/2008,"08/04/2008",7/10/2013,"07/10/2013"
"Biologics",49827,"Terminated","The Blood Alliance, Inc.","Jacksonville","FL","US","Voluntary: Firm Initiated","FAX","FL, MO","B-1686-13","Class II","Red Blood Cells Leukocytes Reduced","W118808540372; 3629542",".","2 units","Blood products, collected from a donor with a history of high risk behavior, was distributed.",8/4/2008,"08/04/2008",7/10/2013,"07/10/2013"
"Biologics",49838,"Terminated","American National Red Cross (The)","West Henrietta","NY","US","Voluntary: Firm Initiated","Telephone","New York","B-1325-13","Class II","Red Blood Cells (Apheresis) Leukocytes Reduced","01KL11353",".","1 ","Blood product, which may have been contaminated during collection, was distributed.",8/8/2008,"08/08/2008",6/5/2013,"06/05/2013"
"Biologics",49844,"Terminated","The American National Red Cross South Carolina Region","Columbia","SC","US","Voluntary: Firm Initiated","Telephone","SC","B-1718-13","Class III","Red Blood Cells Leukocytes Reduced","036KC23040, 036KC23041, 036KC23042, 036KC23043, 036KC23044, 036KC23045, 036KC23046, 036KC23047, 036KC23049, 036KC23050, 036KC23051, 036KC23052, 036KC23053, 036KC23054, 036KC23055, 036KC23056",".","16 units","Blood products, lacking assurance of having been maintained at an acceptable temperature during shipping, were distributed. ",7/31/2008,"07/31/2008",7/17/2013,"07/17/2013"
"Biologics",49844,"Terminated","The American National Red Cross South Carolina Region","Columbia","SC","US","Voluntary: Firm Initiated","Telephone","SC","B-1719-13","Class III","Plasma Frozen","36KC23043, 036KC23053, 036KC23054",".","3 units","Blood products, lacking assurance of having been maintained at an acceptable temperature during shipping, were distributed. ",7/31/2008,"07/31/2008",7/17/2013,"07/17/2013"
"Biologics",49869,"Terminated","American National Red Cross","Portland","OR","US","Voluntary: Firm Initiated","Letter","Oregon and California.","B-0170-13","Class II","Platelets Pheresis Leukocytes Reduced","21FP45176",".","1 component","Blood products, labeled as leukoreduced without the assurance that they met the criteria for leukoreduced products, were distributed.",8/20/2008,"08/20/2008",1/23/2013,"01/23/2013"
"Biologics",49869,"Terminated","American National Red Cross","Portland","OR","US","Voluntary: Firm Initiated","Letter","Oregon and California.","B-0169-13","Class II","Platelets Pheresis Leukocytes Reduced Irradiated","21FP45176",".","1 component","Blood products, labeled as leukoreduced without the assurance that they met the criteria for leukoreduced products, were distributed.",8/20/2008,"08/20/2008",1/23/2013,"01/23/2013"
"Biologics",49870,"Terminated","DCI Biologicals Orlando LLC","Jacksonville","FL","US","Voluntary: Firm Initiated","FAX","California.","B-2348-13","Class II","Source Plasma","JK0207049; JK0207246;J K0209375; JK0209743; JK0210576; JK0210963;JK0211892.",".","7 units","Blood products, collected from a donor who had been incarcerated, were distributed. ",9/8/2008,"09/08/2008",9/18/2013,"09/18/2013"
"Biologics",49874,"Terminated","American Red Cross Blood Services","Saint Louis","MO","US","Voluntary: Firm Initiated","Letter","Arkansas","B-0641-13","Class II","Red Blood Cells Leukocytes Reduced","011FY45853",".","1 Unit","Blood product, collected from a donor who did not respond to questions regarding increased risk for vCJD, was distributed.",8/15/2008,"08/15/2008",2/27/2013,"02/27/2013"
"Biologics",49895,"Terminated","American National Red Cross (The)","Pomona","CA","US","Voluntary: Firm Initiated","Telephone","California","B-1626-13","Class III","Red Blood Cells Leukocytes Reduced","06LH04370",,"1 unit","Blood product, in which quality control did not meet specifications, was distributed.",8/4/2008,"08/04/2008",7/3/2013,"07/03/2013"
"Biologics",49899,"Terminated","American Red Cross Blood Services","Saint Louis","MO","US","Voluntary: Firm Initiated","Letter","Tennessee; Missouri","B-0186-13","Class III","Blood and Blood Products for Reprocessing","011FZ82900",".","1 Unit","Blood products, collected from a donor whose suitability to donate was not adequately determined, were distributed.",8/8/2008,"08/08/2008",1/23/2013,"01/23/2013"
"Biologics",49899,"Terminated","American Red Cross Blood Services","Saint Louis","MO","US","Voluntary: Firm Initiated","Letter","Tennessee; Missouri","B-0185-13","Class II","Red Blood Cells Leukocytes Reduced","011FZ82900",".","1 Unit","Blood products, collected from a donor whose suitability to donate was not adequately determined, were distributed.",8/8/2008,"08/08/2008",1/23/2013,"01/23/2013"
"Biologics",49905,"Terminated","CSL Plasma","Lexington","KY","US","Voluntary: Firm Initiated","Letter","IL, Switzerland, Germany","B-0089-14","Class II","Source Plasma","0530530359; 0530516500; 0530513651; 0530513199; 0530511972; 0530511294; 0530510345; 0530509467; 0530509099; 0530507871; 0530507023; 0530506644; 0530504545; 0530483234; 0530482334; 0530480575; 0530479801; 0530479333; 0530478571; 0530478139; 0530477427; 0530476965; 0530475851; 0530475047; 0530474676; 0530473408; 0530472889; 0530472353; 0530469574; 0530469074; 0530468635; 0530468074; 0530467575; 0530466937; 0530466432; 0530465749; 0530465257; 0530464686; 0530464238; 0530463664; 0530463232; 0530462578; 0530462116; 0530544161; 0530530359; 0530516500; 0530513651; 0530513199; 0530512367; 0530511972; 0530511294; 0530510345; 0530509467; 0530509099; 0530507871; 0530507023; 0530506644; 0530505778; 0530505042; 0530504545; 0530483706; 0530483234; 0530482334;0530481899; 0530481105; 0530480575; 0530479801; 0530479333; 0530478571; 0530478139; 0530477427; 0530476965; 0530475851; 0530475047; 0530474676; 0530473408; 0530472889; 0530472353; 0530469574; 0530469074; 0530468635; 0530468074; 0530467575;0530466937; 0530466432; 0530465749; 0530465257; 0530464686; 0530464238; 0530463664; 0530463232; 0530462578; 0530462116; 0530461536; 0530461057; 0530460570; 0530459936; 0530459582; 0530459034; 0530458638; 0530457431; 0530457123; 0530456573; 0530456250; 0530455730; 0530455456; 0530454827; 0530454513; 0530453871; 0530453506; 0530452905; 0530452574; 0530451939; 0530451645",".","70 units","Blood products, collected from a donor in which donor suitability was not adequately determined, were distributed.",7/15/2008,"07/15/2008",12/4/2013,"12/04/2013"
"Biologics",49906,"Terminated","Puget Sound Blood Center and Program","Seattle","WA","US","Voluntary: Firm Initiated","FAX","Austria.","B-0485-13","Class II","Blood and Blood Products for Reprocessing","W141608611758",,"1 unit","Blood product, collected from a donor who was at risk for variant Creutzfeldt-Jakob disease (vCJD), was distributed.",9/11/2008,"09/11/2008",2/13/2013,"02/13/2013"
"Biologics",49910,"Terminated","Puget Sound Blood Center","Seattle","WA","US","Voluntary: Firm Initiated","Letter","Washington","B-0218-13","Class II","Platelets Pheresis Leukocytes Reduced Irradiated","W141608084774",".","1 unit","Blood product, collected from a donor who traveled to an area considered endemic for malaria, was distributed.",8/25/2008,"08/25/2008",1/16/2013,"01/16/2013"
"Biologics",49911,"Terminated","Florida Blood Services, Inc.","St Petersburg","FL","US","Voluntary: Firm Initiated","FAX","Florida","B-1707-13","Class III","Red Blood Cells Leukocytes Reduced"," W03940851263400",,"1","Blood product, collected from a donor, whose suitability to donate was not adequately determined, was distributed.",8/26/2008,"08/26/2008",7/31/2013,"07/31/2013"
"Biologics",49926,"Terminated","Department of the Navy","Camp Lejeune","NC","US","Voluntary: Firm Initiated","FAX","MD, Iraq","B-2161-13","Class II","Red Blood Cells","W020407001257(Part A)",,"1 unit","Blood products, collected from a donor whose suitability to donate were not adequately determined, were distributed.",2/21/2008,"02/21/2008",9/4/2013,"09/04/2013"
"Biologics",49928,"Terminated","American National Red Cross (The)","Tucson","AZ","US","Voluntary: Firm Initiated","Letter","CA, AZ","B-0042-14","Class II","Red Blood Cells Leukocytes Reduced","07GJ22668",".","1 unit","Blood products, collected from a donor for whom donor suitability was not adequately determined, were distributed.",8/20/2008,"08/20/2008",10/30/2013,"10/30/2013"
"Biologics",49928,"Terminated","American National Red Cross (The)","Tucson","AZ","US","Voluntary: Firm Initiated","Letter","CA, AZ","B-0043-14","Class III","Plasma Frozen","07GJ22668",".","1 unit","Blood products, collected from a donor for whom donor suitability was not adequately determined, were distributed.",8/20/2008,"08/20/2008",10/30/2013,"10/30/2013"
"Biologics",49930,"Terminated","Interstate Blood Bank Inc Mo","Saint Louis","MO","US","Voluntary: Firm Initiated","FAX","Austria","B-0077-13","Class II","Source Plasma","LZ090296; LZ089770",".","2 Units","Blood products, collected from a donor who did not have a complete physical examination, were distributed.",8/22/2008,"08/22/2008",1/23/2013,"01/23/2013"
"Biologics",49941,"Terminated","American National Red Cross (The)","West Henrietta","NY","US","Voluntary: Firm Initiated","Telephone","New York","B-1322-13","Class II","Red Blood Cells Leukocytes Reduced","01KM46955",".","1 component ","Blood products, collected from a donor whose suitability to donate was not adequately determined, were distributed.",8/21/2008,"08/21/2008",6/5/2013,"06/05/2013"
"Biologics",49941,"Terminated","American National Red Cross (The)","West Henrietta","NY","US","Voluntary: Firm Initiated","Telephone","New York","B-1324-13","Class II","Plasma Frozen","01KM46955",".","1 component","Blood products, collected from a donor whose suitability to donate was not adequately determined, were distributed.",8/21/2008,"08/21/2008",6/5/2013,"06/05/2013"
"Biologics",49941,"Terminated","American National Red Cross (The)","West Henrietta","NY","US","Voluntary: Firm Initiated","Telephone","New York","B-1323-13","Class II","Platelets Leukocytes Reduced","01KM46955",".","1 component ","Blood products, collected from a donor whose suitability to donate was not adequately determined, were distributed.",8/21/2008,"08/21/2008",6/5/2013,"06/05/2013"
"Biologics",49948,"Terminated","LifeSouth Community Blood Centers, Inc.","Brooksville","FL","US","Voluntary: Firm Initiated","FAX","FL","B-1164-13","Class II","Platelets Pheresis Leukocytes Reduced ","72H552220",".","1 unit","Blood product, with a low platelet count, was distributed.",8/13/2008,"08/13/2008",5/29/2013,"05/29/2013"
"Biologics",49951,"Terminated","ZLB Bioplasma, Inc.","Lexington","KY","US","Voluntary: Firm Initiated","Letter","IL, Germany, and Switzerland.","B-2313-13","Class II","Source Plasma","0530546029, 0530545681, 0530542822, 0530542328, 0530540867, 0530540564, 0530539531, 0530539185, 0530537708, 0530536769, 0530536312, 0530533622, 0530533283, 0530532387, 0530531990, 0530530965, 0530530556, 0530529630, 0530529182, 0530528280, 0530526014, 0530525450, 0530521176, and 0530520099. ",,"24 units","Blood products, collected from a donor whose physical was overdue, were distributed.",8/22/2009,"08/22/2009",9/25/2013,"09/25/2013"
"Biologics",49991,"Terminated","American National Red Cross (The)","West Henrietta","NY","US","Voluntary: Firm Initiated","Telephone","NY","B-1372-13","Class III","Red Blood Cells Leukocytes Reduced Washed","001Y66804; 001KS73999",".","2 units","Blood products, not prepared in accordance with specifications, were distributed. ",8/22/2008,"08/22/2008",7/10/2013,"07/10/2013"
"Biologics",49996,"Terminated","DCI Biologicals Bryan LLC","Bryan","TX","US","Voluntary: Firm Initiated","E-Mail","UK","B-0327-13","Class II","Source Plasma","BY0261044, BY0261311, BY0261769, BY0261701",".","4 units","Blood products, which were not quarantined after receiving post donation information regarding an undocumented piercing, were distributed.",8/14/2008,"08/14/2008",2/6/2013,"02/06/2013"
"Biologics",50020,"Terminated","American National Red Cross (The)","Saint Louis","MO","US","Voluntary: Firm Initiated","FAX","IL","B-0721-13","Class II","Plasma Frozen","011LQ61233",,"1 unit","Blood products, which were collected from a donor in which donor suitability was not adequately determined, were distributed.",9/4/2008,"09/04/2008",3/6/2013,"03/06/2013"
"Biologics",50020,"Terminated","American National Red Cross (The)","Saint Louis","MO","US","Voluntary: Firm Initiated","FAX","IL","B-0720-13","Class II","Red Blood Cells Leukocytes Reduced","011LQ61233",,"1 unit","Blood products, which were collected from a donor in which donor suitability was not adequately determined, were distributed.",9/4/2008,"09/04/2008",3/6/2013,"03/06/2013"
"Biologics",50028,"Terminated","Florida's Blood Centers, Inc.","Orlando","FL","US","Voluntary: Firm Initiated","E-Mail","Austria","B-1091-13","Class II","Recovered Plasma Frozen within 24 Hour of Phlebotomy (Blood and Blood Products for Reprocessing).","5575117; 5266741",".","2 units","Blood products, collected from a donor who was at risk for variant Creutzfeldt-Jakob disease (vCJD), were distributed.",8/27/2008,"08/27/2008",5/15/2013,"05/15/2013"
"Biologics",50028,"Terminated","Florida's Blood Centers, Inc.","Orlando","FL","US","Voluntary: Firm Initiated","E-Mail","Austria","B-1090-13","Class II","Fresh Frozen Plasma","574252",".","1 unit","Blood products, collected from a donor who was at risk for variant Creutzfeldt-Jakob disease (vCJD), were distributed.",8/27/2008,"08/27/2008",5/15/2013,"05/15/2013"
"Biologics",50030,"Terminated","American National Red Cross (The)","Portland","OR","US","Voluntary: Firm Initiated","Letter","Maryland and California","B-0459-13","Class II","Red Blood Cells Leukocytes Reduced","21LZ09600",".","1 component","Blood products, collected from a donor whose suitability to donate was not adequately determined, were distributed.",8/27/2008,"08/27/2008",1/23/2013,"01/23/2013"
"Biologics",50030,"Terminated","American National Red Cross (The)","Portland","OR","US","Voluntary: Firm Initiated","Letter","Maryland and California","B-0461-13","Class III","Blood and Blood Products for Reprocessing","21LZ09600",".","1 component","Blood products, collected from a donor whose suitability to donate was not adequately determined, were distributed.",8/27/2008,"08/27/2008",1/23/2013,"01/23/2013"
"Biologics",50030,"Terminated","American National Red Cross (The)","Portland","OR","US","Voluntary: Firm Initiated","Letter","Maryland and California","B-0460-13","Class II","Cryoprecipitated AHF","21LZ09600",".","1 component","Blood products, collected from a donor whose suitability to donate was not adequately determined, were distributed.",8/27/2008,"08/27/2008",1/23/2013,"01/23/2013"
"Biologics",50036,"Terminated","Mississippi Valley Reg Bld Ctr","Davenport","IA","US","Voluntary: Firm Initiated","Letter","Iowa","B-0470-13","Class II","Platelets Pheresis Leukocytes Reduced Irradiated","W038308043344",,"1 Unit","Blood product, which did not meet acceptable product specifications, was distributed.",10/6/2008,"10/06/2008",2/13/2013,"02/13/2013"
"Biologics",50052,"Terminated","American National Red Cross","Portland","OR","US","Voluntary: Firm Initiated","Letter","Oregon.","B-0174-13","Class II","Red Blood Cells Leukocytes Reduced","21LZ02870; 21LZ07089; 21LZ10267; 21LZ14250.",".","4 ","Blood products, collected from a donor who reported travel to a malarial endemic area, were distributed.",9/5/2008,"09/05/2008",1/23/2013,"01/23/2013"
"Biologics",50055,"Terminated","American National Red Cross","Salt Lake City","UT","US","Voluntary: Firm Initiated","Telephone","California.","B-0976-13","Class II","Red Blood Cells Leukocytes Reduced","20LE13245.",,"1 unit","Blood products, collected from a donor in whom donor suitability was not adequately determined, were distributed.",8/29/2008,"08/29/2008",4/17/2013,"04/17/2013"
"Biologics",50055,"Terminated","American National Red Cross","Salt Lake City","UT","US","Voluntary: Firm Initiated","Telephone","California.","B-0977-13","Class III","Blood and Blood Products for Reprocessing","20LE13245.",,"1 unit","Blood products, collected from a donor in whom donor suitability was not adequately determined, were distributed.",8/29/2008,"08/29/2008",4/17/2013,"04/17/2013"
"Biologics",50246,"Terminated","Biomat USA, Inc.","Phoenix","AZ","US","Voluntary: Firm Initiated","FAX","CA, Spain","B-2038-13","Class II","Source Plasma","0230303925 0230288437 0230286392 0230264093 0230263403 0230262523 0230227677 0230217519 0230216931 0230215526 0230213763 0230213156 0230212633 0230211886 0230210832 0230205537 0230203735 0230202941 0230202048 0230201656 0230184950 0230184135 ",".","22 units","Blood products, which were collected from a donor in which donor suitability was not adequately determined, were distributed.",8/25/2008,"08/25/2008",8/14/2013,"08/14/2013"
"Biologics",50250,"Terminated","Biomat USA, Inc.","Los Angeles","CA","US","Voluntary: Firm Initiated","Letter","California, Spain","B-0326-13","Class II","Source Plasma","0420047676, 0420047864, 0420049894, 0420058168",".","4 units","Blood products, collected from a donor who received a tattoo within one year of donation, were distributed.",5/30/2008,"05/30/2008",1/16/2013,"01/16/2013"
"Biologics",50265,"Terminated","LifeSouth Community Blood Centers, Inc.","Brooksville","FL","US","Voluntary: Firm Initiated","FAX","Florida","B-0091-14","Class II","Platelets Pheresis Leukocytes Reduced ","72H626599",".","1","Blood product, which did not meet acceptable product specifications, was distributed.",9/25/2008,"09/25/2008",12/4/2013,"12/04/2013"
"Biologics",50271,"Terminated","The Blood Alliance, Inc.","Jacksonville","FL","US","Voluntary: Firm Initiated","Other","FL","B-1541-13","Class II","Red Blood Cells (Apheresis) Leukocytes Reduced","W118808632579- part 1; W118808632579-part 2",".","2 units","Blood products, which did not meet the acceptable product specifications, were distributed.",10/8/2008,"10/08/2008",7/10/2013,"07/10/2013"
"Biologics",50275,"Terminated","Florida's Blood Centers, Inc.","Orlando","FL","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Florida","B-1029-13","Class II","Red Blood Cells Leukocytes Reduced","6229009; 5790237",".","2 units","Blood products, which were collected from a donor who traveled to a malarial endemic area, were distributed.",9/18/2008,"09/18/2008",4/24/2013,"04/24/2013"
"Biologics",50275,"Terminated","Florida's Blood Centers, Inc.","Orlando","FL","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Florida","B-1030-13","Class II","Cryoprecipitated AHF, Pooled","5801688",".","1 unit","Blood products, which were collected from a donor who traveled to a malarial endemic area, were distributed.",9/18/2008,"09/18/2008",4/24/2013,"04/24/2013"
"Biologics",50294,"Terminated","Community Blood Center Of Gtr KC","Kansas City","MO","US","Voluntary: Firm Initiated","Telephone","Kansas","B-0904-13","Class III","Red Blood Cells Leukocytes Reduced","W045008070736",".","1 Unit","Blood product, labeled as an AS product but with no red cell preservative solution added, was distributed.",10/23/2008,"10/23/2008",4/10/2013,"04/10/2013"
"Biologics",50295,"Terminated","Community Blood Center of Greater Kansas City","Kansas City","MO","US","Voluntary: Firm Initiated","Telephone","KS, MO, Austria","B-0332-13","Class II","Fresh Frozen Plasma","W045008003256",".","1 unit","Blood products, collected from a donor with a history of living with an individual diagnosed with Hepatitis B, were distributed.",9/25/2008,"09/25/2008",2/6/2013,"02/06/2013"
"Biologics",50295,"Terminated","Community Blood Center of Greater Kansas City","Kansas City","MO","US","Voluntary: Firm Initiated","Telephone","KS, MO, Austria","B-0333-13","Class II","Recovered Plasma","W045008057390",".","1 unit","Blood products, collected from a donor with a history of living with an individual diagnosed with Hepatitis B, were distributed.",9/25/2008,"09/25/2008",2/6/2013,"02/06/2013"
"Biologics",50295,"Terminated","Community Blood Center of Greater Kansas City","Kansas City","MO","US","Voluntary: Firm Initiated","Telephone","KS, MO, Austria","B-0331-13","Class II","Red Blood Cells Leukocytes Reduced","W045008003256, W045008057390",".","2 units","Blood products, collected from a donor with a history of living with an individual diagnosed with Hepatitis B, were distributed.",9/25/2008,"09/25/2008",2/6/2013,"02/06/2013"
"Biologics",50296,"Terminated","American National Red Cross (The)","Saint Louis","MO","US","Voluntary: Firm Initiated","Letter","IL, NJ,","B-0722-13","Class II","Red Blood Cells Leukocytes Reduced","011KJ12276; 011KX08948",,"2 unit","Blood products, which were collected from a donor in which donor suitability was not adequately determined, were distributed.",10/17/2008,"10/17/2008",3/6/2013,"03/06/2013"
"Biologics",50296,"Terminated","American National Red Cross (The)","Saint Louis","MO","US","Voluntary: Firm Initiated","Letter","IL, NJ,","B-0723-13","Class III","Blood and Blood Products for Reprocessing","011KJ12276;011KX08948",,"2 units","Blood products, which were collected from a donor in which donor suitability was not adequately determined, were distributed.",10/17/2008,"10/17/2008",3/6/2013,"03/06/2013"
"Biologics",50299,"Terminated","Florida's Blood Centers, Inc.","Orlando","FL","US","Voluntary: Firm Initiated","Letter","Florida","B-0794-13","Class III","Red Blood Cells","9093156, 9092753, 9092752, 9092751, 9092750, 9092749, 9092748, 9092368, 9092367, 9092362, 9092360, 9092357, 9092234, 9092231, 9092227, 9092106, 9092102, 9091789, 9091785, 9091784",".","20 units","Blood products, which reached an unacceptable temperature during shipment, were distributed.",9/8/2008,"09/08/2008",5/1/2013,"05/01/2013"
"Biologics",50302,"Terminated","Florida's Blood Centers, Inc.","Orlando","FL","US","Voluntary: Firm Initiated","Letter","Florida","B-1044-13","Class II","Red Blood Cells","9094451, 9091555, 9085921",".","3 units","Blood products, collected from a donor who lived in an area considered endemic for malaria, were distributed.",10/14/2008,"10/14/2008",5/1/2013,"05/01/2013"
"Biologics",50328,"Terminated","American National Red Cross (The)","Dedham","MA","US","Voluntary: Firm Initiated","FAX","CA, MA, NH, VT","B-0574-13","Class II","Red Blood Cells Leukocytes Reduced","004KM33220;004KM61922;004KM69676;004KQ32543;004KT69103",".","5 units","Blood products, which were collected from a donor in which donor suitability was not adequately determined, were distributed.",9/13/2008,"09/13/2008",2/27/2013,"02/27/2013"
"Biologics",50328,"Terminated","American National Red Cross (The)","Dedham","MA","US","Voluntary: Firm Initiated","FAX","CA, MA, NH, VT","B-0576-13","Class II","Plasma Frozen","004KT69103",".","1 unit","Blood products, which were collected from a donor in which donor suitability was not adequately determined, were distributed.",9/13/2008,"09/13/2008",2/27/2013,"02/27/2013"
"Biologics",50328,"Terminated","American National Red Cross (The)","Dedham","MA","US","Voluntary: Firm Initiated","FAX","CA, MA, NH, VT","B-0575-13","Class III","Blood and Blood Products for Reprocessing","004KM69676",".","1 unit","Blood products, which were collected from a donor in which donor suitability was not adequately determined, were distributed.",9/13/2008,"09/13/2008",2/27/2013,"02/27/2013"
"Biologics",50329,"Terminated","American National Red Cross (The)","Dedham","MA","US","Voluntary: Firm Initiated","Telephone","NH, VT","B-0558-13","Class III","Plasma Frozen","004KK55198",,"1 unit","Blood products, which were collected from a donor in which donor suitability was not adequately determined, were distributed.",9/22/2008,"09/22/2008",2/20/2013,"02/20/2013"
"Biologics",50329,"Terminated","American National Red Cross (The)","Dedham","MA","US","Voluntary: Firm Initiated","Telephone","NH, VT","B-0557-13","Class II","Red Blood Cells Leukocytes Reduced","004KK55198",,"1 unit","Blood products, which were collected from a donor in which donor suitability was not adequately determined, were distributed.",9/22/2008,"09/22/2008",2/20/2013,"02/20/2013"
"Biologics",50330,"Terminated","American National Red Cross (The)","Farmington","CT","US","Voluntary: Firm Initiated","FAX","NE","B-0551-13","Class II","Platelets Leukocytes Reduced","033GM35609",,"1 unit","Blood products, which were collected from a donor in which donor suitability was not adequately determined, were distributed.",9/18/2008,"09/18/2008",2/20/2013,"02/20/2013"
"Biologics",50330,"Terminated","American National Red Cross (The)","Farmington","CT","US","Voluntary: Firm Initiated","FAX","NE","B-0554-13","Class II","Red Blood Cells (Apheresis) Leukocytes Reduced","033FE00104B2;033FE00104B1",,"2 units","Blood products, which were collected from a donor in which donor suitability was not adequately determined, were distributed.",9/18/2008,"09/18/2008",2/20/2013,"02/20/2013"
"Biologics",50330,"Terminated","American National Red Cross (The)","Farmington","CT","US","Voluntary: Firm Initiated","FAX","NE","B-0552-13","Class III","Blood and Blood Products for Reprocessing","033GM37984",,"1 unit","Blood products, which were collected from a donor in which donor suitability was not adequately determined, were distributed.",9/18/2008,"09/18/2008",2/20/2013,"02/20/2013"
"Biologics",50330,"Terminated","American National Red Cross (The)","Farmington","CT","US","Voluntary: Firm Initiated","FAX","NE","B-0553-13","Class II","Platelets Pheresis Leukocytes Reduced","033FP63417P1;033FP63417P2",,"2 units","Blood products, which were collected from a donor in which donor suitability was not adequately determined, were distributed.",9/18/2008,"09/18/2008",2/20/2013,"02/20/2013"
"Biologics",50330,"Terminated","American National Red Cross (The)","Farmington","CT","US","Voluntary: Firm Initiated","FAX","NE","B-0548-13","Class II","Red Blood Cells Leukocytes Reduced","033GM37984; 033GM55654; 033GW23732; 033GW54331; 033GM57596; 033GM59812 ",,"6 units","Blood products, which were collected from a donor in which donor suitability was not adequately determined, were distributed.",9/18/2008,"09/18/2008",2/20/2013,"02/20/2013"
"Biologics",50330,"Terminated","American National Red Cross (The)","Farmington","CT","US","Voluntary: Firm Initiated","FAX","NE","B-0549-13","Class II","Platelets Pooled Leukocytes Reduced","033GM57596;033GM55654",,"2 units","Blood products, which were collected from a donor in which donor suitability was not adequately determined, were distributed.",9/18/2008,"09/18/2008",2/20/2013,"02/20/2013"
"Biologics",50330,"Terminated","American National Red Cross (The)","Farmington","CT","US","Voluntary: Firm Initiated","FAX","NE","B-0555-13","Class II","Red Blood Cells Leukocytes Reduced Irradiated","033GM35609",,"1 unit","Blood products, which were collected from a donor in which donor suitability was not adequately determined, were distributed.",9/18/2008,"09/18/2008",2/20/2013,"02/20/2013"
"Biologics",50330,"Terminated","American National Red Cross (The)","Farmington","CT","US","Voluntary: Firm Initiated","FAX","NE","B-0550-13","Class II","Fresh Frozen Plasma","033GM57596;033GW54331;033GM55654",,"3 units","Blood products, which were collected from a donor in which donor suitability was not adequately determined, were distributed.",9/18/2008,"09/18/2008",2/20/2013,"02/20/2013"
"Biologics",50330,"Terminated","American National Red Cross (The)","Farmington","CT","US","Voluntary: Firm Initiated","FAX","NE","B-0549-13","Class II","Platelets Pooled Leukocytes Reduced","033GM57596;033GM55654",".","2 units","Blood products, which were collected from a donor in which donor suitability was not adequately determined, were distributed.",9/18/2008,"09/18/2008",4/24/2013,"04/24/2013"
"Biologics",50330,"Terminated","American National Red Cross (The)","Farmington","CT","US","Voluntary: Firm Initiated","FAX","NE","B-0553-13","Class II","Platelets Pheresis Leukocytes Reduced","033FP63417P1;033FP63417P2",".","2 units","Blood products, which were collected from a donor in which donor suitability was not adequately determined, were distributed.",9/18/2008,"09/18/2008",4/24/2013,"04/24/2013"
"Biologics",50330,"Terminated","American National Red Cross (The)","Farmington","CT","US","Voluntary: Firm Initiated","FAX","NE","B-0550-13","Class II","Fresh Frozen Plasma","033GM57596;033GW54331;033GM55654",".","3 units","Blood products, which were collected from a donor in which donor suitability was not adequately determined, were distributed.",9/18/2008,"09/18/2008",4/24/2013,"04/24/2013"
"Biologics",50330,"Terminated","American National Red Cross (The)","Farmington","CT","US","Voluntary: Firm Initiated","FAX","NE","B-0552-13","Class III","Blood and Blood Products for Reprocessing","033GM37984",".","1 unit","Blood products, which were collected from a donor in which donor suitability was not adequately determined, were distributed.",9/18/2008,"09/18/2008",4/24/2013,"04/24/2013"
"Biologics",50330,"Terminated","American National Red Cross (The)","Farmington","CT","US","Voluntary: Firm Initiated","FAX","NE","B-0555-13","Class II","Red Blood Cells Leukocytes Reduced Irradiated","033GM35609",".","1 unit","Blood products, which were collected from a donor in which donor suitability was not adequately determined, were distributed.",9/18/2008,"09/18/2008",4/24/2013,"04/24/2013"
"Biologics",50330,"Terminated","American National Red Cross (The)","Farmington","CT","US","Voluntary: Firm Initiated","FAX","NE","B-0554-13","Class II","Red Blood Cells (Apheresis) Leukocytes Reduced","033FE00104B2;033FE00104B1",".","2 units","Blood products, which were collected from a donor in which donor suitability was not adequately determined, were distributed.",9/18/2008,"09/18/2008",4/24/2013,"04/24/2013"
"Biologics",50330,"Terminated","American National Red Cross (The)","Farmington","CT","US","Voluntary: Firm Initiated","FAX","NE","B-0551-13","Class II","Platelets Leukocytes Reduced","033GM35609",".","1 unit","Blood products, which were collected from a donor in which donor suitability was not adequately determined, were distributed.",9/18/2008,"09/18/2008",4/24/2013,"04/24/2013"
"Biologics",50330,"Terminated","American National Red Cross (The)","Farmington","CT","US","Voluntary: Firm Initiated","FAX","NE","B-0548-13","Class II","Red Blood Cells Leukocytes Reduced","033GM37984; 033GM55654; 033GW23732; 033GW54331; 033GM57596;033GM59812 ",".","6 units","Blood products, which were collected from a donor in which donor suitability was not adequately determined, were distributed.",9/18/2008,"09/18/2008",4/24/2013,"04/24/2013"
"Biologics",50354,"Terminated","Talecris Plasma Resources, Inc.","Research Triangle Park","NC","US","Voluntary: Firm Initiated","FAX","North Carolina","B-1152-13","Class II","Source Plasma","366104146, 366103699, 366096948, 366096500, 366094780, 366093173, 366092790, 366089681, 366089554, 366058810, 366058665, 366057740, 366057631, 366057233, 366057099, 366055153, 366054076, 366053858, 366053163, 366052880, 366051320, 366051080, 366050457, 366050150, 366049584, 366049370, 366046687, 366046611",".","28 units ","Blood products, collected from a donor with a history of intravenous drug use, were distributed.",11/4/2008,"11/04/2008",5/1/2013,"05/01/2013"
"Biologics",50384,"Terminated","American National Red Cross (The)","West Henrietta","NY","US","Voluntary: Firm Initiated","Letter","NY","B-1728-13","Class II","Red Blood Cells","01KG98036",,"1 unit","Blood products, collected from a donor who was at risk for variant Creutzfeldt-Jakob disease (vCJD), were distributed.",11/4/2008,"11/04/2008",8/21/2013,"08/21/2013"
"Biologics",50384,"Terminated","American National Red Cross (The)","West Henrietta","NY","US","Voluntary: Firm Initiated","Letter","NY","B-1729-13","Class II","Blood and Blood Products for Reprocessing","01KG98036",,"1 unit","Blood products, collected from a donor who was at risk for variant Creutzfeldt-Jakob disease (vCJD), were distributed.",11/4/2008,"11/04/2008",8/21/2013,"08/21/2013"
"Biologics",50385,"Terminated","American National Red Cross (The)","West Henrietta","NY","US","Voluntary: Firm Initiated","Letter","New York","B-0905-13","Class II","Red Blood Cells Leukocytes Reduced","01Q17523",".","1 component ","Blood products, collected from a donor who was previously deferred after disclosing high risk behavior, were distributed.",9/23/2008,"09/23/2008",4/24/2013,"04/24/2013"
"Biologics",50385,"Terminated","American National Red Cross (The)","West Henrietta","NY","US","Voluntary: Firm Initiated","Letter","New York","B-0906-13","Class II","Platelets Leukocytes Reduced","01Q17523",".","1 component ","Blood products, collected from a donor who was previously deferred after disclosing high risk behavior, were distributed.",9/23/2008,"09/23/2008",4/24/2013,"04/24/2013"
"Biologics",50385,"Terminated","American National Red Cross (The)","West Henrietta","NY","US","Voluntary: Firm Initiated","Letter","New York","B-0907-13","Class II","Blood and Blood Products for Reprocessing","01Q17523",".","1 component ","Blood products, collected from a donor who was previously deferred after disclosing high risk behavior, were distributed.",9/23/2008,"09/23/2008",4/24/2013,"04/24/2013"
"Biologics",50386,"Terminated","American National Red Cross (The)","West Henrietta","NY","US","Voluntary: Firm Initiated","Telephone","NY","B-1024-13","Class II","Red Blood Cells Leukocytes Reduced","01GJ97127",,"1 component ","Blood products, collected from donors for whom donor suitability was not adequately determined, were distributed.",9/4/2008,"09/04/2008",5/8/2013,"05/08/2013"
"Biologics",50386,"Terminated","American National Red Cross (The)","West Henrietta","NY","US","Voluntary: Firm Initiated","Telephone","NY","B-1025-13","Class III","Blood and Blood Products for Reprocessing","01GJ97127",,"1 component ","Blood products, collected from donors for whom donor suitability was not adequately determined, were distributed.",9/4/2008,"09/04/2008",5/8/2013,"05/08/2013"
"Biologics",50416,"Terminated","Tacoma Pierce County Blood Bank","Tacoma","WA","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Washington and Utah","B-0908-13","Class III","Red Blood Cells Leukocytes Reduced","W127808500548, W127808500549, W127808500555, W127808500568, W127808500584, W127808500589, N 22878, N 22883, V 72291.",".","9 ","Blood products, collected using a copper sulfate solution which had unacceptable specific gravity QC results were distributed.",9/19/2008,"09/19/2008",6/5/2013,"06/05/2013"
"Biologics",50416,"Terminated","Tacoma Pierce County Blood Bank","Tacoma","WA","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Washington and Utah","B-0910-13","Class III","Red Blood Cells Leukocytes Reduced Irradiated","W127808500543, W127808500547, W127808500570, W127808500574, W127808500578, W127808500581, W127808500585, N 22879",".","8 ","Blood products, collected using a copper sulfate solution which had unacceptable specific gravity QC results, were distributed.",9/19/2008,"09/19/2008",6/5/2013,"06/05/2013"
"Biologics",50416,"Terminated","Tacoma Pierce County Blood Bank","Tacoma","WA","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Washington and Utah","B-0909-13","Class III","Red Blood Cells","W127808500544, W127808500546, W127808500550, W127808500551, W127808500556, W127808500558, W127808500562, W127808500565, W127808500567, W127808500569, W127808500572, W127808500573, W127808500575, W127808500577, W127808500579, W127808500580, W127808500582, W127808500583, W127808500587, W127808500588, N 22876, N 22880, N 22881, V 72286, V 72287, V 72288, V 72292, V 72293, V 72294.",".","29 ","Blood products, collected using a copper sulfate solution which had unacceptable specific gravity QC results, were distributed.",9/19/2008,"09/19/2008",6/5/2013,"06/05/2013"
"Biologics",50417,"Terminated","American National Red Cross","Portland","OR","US","Voluntary: Firm Initiated","FAX","Washington.","B-0660-13","Class III","Cryoprecipitated AHF","21LZ10857, 21LZ10863, 21LZ10864, 21GE85270, 21KS75301, 21LG68117, 21LJ62045, 21LK47755, 21LZ11063, 21KW65496, 21KW65814, 21LG67732, 21LV34200, 21LZ09910, 21KS75960, 21LG68533, 21LG68547, 21LG68583, 21LH64005, 21LJ62119, 21LJ62128, 21LK47589, 21LZ09070, 21LZ10746, 21KW65944, 21KW65964, 21LG67958, 21LG68114, 21LG68131, 21LZ11061.",,"30 components","Blood products, which may have reached an unacceptable temperature during shipment, were distributed..",10/2/2008,"10/02/2008",4/3/2013,"04/03/2013"
"Biologics",50418,"Terminated","American National Red Cross (The)","Portland","OR","US","Voluntary: Firm Initiated","Letter","Oregon.","B-0458-13","Class II","Red Blood Cells (Apheresis) Leukocytes Reduced","21LQ32862, 21LQ32862",".","2 components","Blood product, collected from a donor with an unacceptably low hemoglobin, was distributed.",10/21/2008,"10/21/2008",1/23/2013,"01/23/2013"
"Biologics",50431,"Terminated","American National Red Cross (The)","Omaha","NE","US","Voluntary: Firm Initiated","Telephone","PA, CO","B-0734-13","Class II","Plasma Frozen","009FQ38724",,"1 unit","Blood products, which were not quarantined subsequent to receiving post donation information, were distributed.",9/26/2008,"09/26/2008",3/20/2013,"03/20/2013"
"Biologics",50431,"Terminated","American National Red Cross (The)","Omaha","NE","US","Voluntary: Firm Initiated","Telephone","PA, CO","B-0733-13","Class II","Red Blood Cells Leukocytes Reduced","009FQ38724",,"1 unit","Blood products, which were not quarantined subsequent to receiving post donation information, were distributed.",9/26/2008,"09/26/2008",3/20/2013,"03/20/2013"
"Biologics",50433,"Terminated","Mercy Hospital St Louis","Saint Louis","MO","US","Voluntary: Firm Initiated","Telephone","Missouri","B-1306-13","Class III","Red Blood Cells","76FM27469",".","1 unit","Blood product, collected from a donor whose body temperature was not documented, was distributed.",9/24/2008,"09/24/2008",5/1/2013,"05/01/2013"
"Biologics",50434,"Terminated","BioLife Plasma Services L.P.","Springfield","MO","US","Voluntary: Firm Initiated","FAX","CA","B-0346-13","Class II","Source Plasma","08FMOD0324",".","1 unit","Blood product, collected from a donor who did not have a required physical examination, was distributed.",10/31/2008,"10/31/2008",1/9/2013,"01/09/2013"
"Biologics",50436,"Terminated","Tri-counties Blood Bank","Phoenix","AZ","US","Voluntary: Firm Initiated","Telephone","CA","B-1878-13","Class II","Red Blood Cells (Apheresis) Leukocytes Reduced","W142808302845; W142808302845",,"2 units","Blood products, which did not meet the acceptable product specifications, were distributed. ",9/8/2008,"09/08/2008",8/7/2013,"08/07/2013"
"Biologics",50441,"Terminated","San Diego Blood Bank","San Diego","CA","US","Voluntary: Firm Initiated","Letter","CA","B-2082-13","Class II","Red Blood Cells","W044208304007",".","1 unit","Blood products, collected from a donor for whom hemoglobin screening test was not performed, were distributed.",10/23/2008,"10/23/2008",10/2/2013,"10/02/2013"
"Biologics",50444,"Terminated","Csl Plasma Inc","Tempe","AZ","US","Voluntary: Firm Initiated","Letter","Illinois, Switzerland, Germany","B-1629-13","Class II","Source Plasma","4270183014, 4270181851, 4270180003, 4270174788, 4270173161, 4270171887, 4270165471, 4270162492, 4270161125, 4270160357, 4270159126, 4270157892, 4270157329, 4270155736, 4270155211, 4270153782, 4270153425, 4270152091, 4270151567, 4270150167, 4270148507, 4270147032, 4270146491, 4270145367, 4270144221, 4270143653, 4270141052, 4270139728, 4270139214, 4270138216, 4270137713, 4270136676, 4270136156, 4270134929, 4270134542, 4270131147, 4270129852",".","37 units","Blood products, collected from a donor who did not have a complete physical examination, were distributed.",10/7/2008,"10/07/2008",7/24/2013,"07/24/2013"
"Biologics",50455,"Terminated","DCI Biologicals Little Rock LLC","Little Rock","AR","US","Voluntary: Firm Initiated","FAX","UK","B-1144-13","Class II","Source Plasma","LR0305957; LR0306663",,"2","Blood products, which were not quarantined subsequent to receiving information regarding post donation information, were distributed.",10/12/2008,"10/12/2008",5/22/2013,"05/22/2013"
"Biologics",50556,"Terminated","Hoxworth Blood Center University of Cincinnati Medical Center","Cincinnati","OH","US","Voluntary: Firm Initiated","Letter","Ohio.","B-1978-13","Class II","AS-3 Red Blood Cells","3018389, 2921257",,"2 units","Blood products, which were collected from a donor who traveled to a malarial endemic area, were distributed. ",9/17/2008,"09/17/2008",8/7/2013,"08/07/2013"
"Biologics",50556,"Terminated","Hoxworth Blood Center University of Cincinnati Medical Center","Cincinnati","OH","US","Voluntary: Firm Initiated","Letter","Ohio.","B-1976-13","Class II","Fresh Frozen Plasma","2995677",,"1 unit","Blood products, which were collected from a donor who traveled to a malarial endemic area, were distributed. ",9/17/2008,"09/17/2008",8/7/2013,"08/07/2013"
"Biologics",50556,"Terminated","Hoxworth Blood Center University of Cincinnati Medical Center","Cincinnati","OH","US","Voluntary: Firm Initiated","Letter","Ohio.","B-1977-13","Class II","Platelets Pheresis Leukocytes Reduced","2964991(Part A), 2964991(Part B), 2921257, 2995677(Part A), 2995677(Part B), 3018389(Part A), 3018389(Part B)",,"7 units","Blood products, which were collected from a donor who traveled to a malarial endemic area, were distributed. ",9/17/2008,"09/17/2008",8/7/2013,"08/07/2013"
"Biologics",50557,"Terminated","Hoxworth Blood Center University of Cincinnati Medical Center","Cincinnati","OH","US","Voluntary: Firm Initiated","Letter","Kentucky, Ohio.","B-1975-13","Class II","Platelets Leukocytes Reduced","2949852",,"1 unit","Blood products, which were collected from a donor who traveled to a malarial endemic area, were distributed.",9/30/2008,"09/30/2008",8/7/2013,"08/07/2013"
"Biologics",50557,"Terminated","Hoxworth Blood Center University of Cincinnati Medical Center","Cincinnati","OH","US","Voluntary: Firm Initiated","Letter","Kentucky, Ohio.","B-1974-13","Class II","Red Blood Cells Leukocytes Reduced","2964223; 2949852",,"2 units","Blood products, which were collected from a donor who traveled to a malarial endemic area, were distributed.",9/30/2008,"09/30/2008",8/7/2013,"08/07/2013"
"Biologics",50558,"Terminated","Hoxworth Blood Center University of Cincinnati Medical Center","Cincinnati","OH","US","Voluntary: Firm Initiated","Letter","OH","B-1973-13","Class II","Red Blood Cells (Apheresis) Leukocytes Reduced","3006921(Part A); 3006921(Part B)",,"2 units","Blood products, collected from a donor taking the medication Proscar, were distributed.",9/23/2008,"09/23/2008",8/7/2013,"08/07/2013"
"Biologics",50562,"Terminated","LifeServe Blood Center","Des Moines","IA","US","Voluntary: Firm Initiated","Letter","Iowa","B-0804-13","Class III","Red Blood Cells Leukocytes Reduced Irradiated","W037908143525; W037908141792; W037908141784; W037908141565; W037908139613",,"5 Units","Blood products, which were labeled with an incorrect expiration date, were distributed..",12/4/2008,"12/04/2008",4/3/2013,"04/03/2013"
"Biologics",50567,"Terminated","American Red Cross Blood Services","Saint Louis","MO","US","Voluntary: Firm Initiated","Letter","Missouri; California","B-0187-13","Class II","Red Blood Cells Leukocytes Reduced","011GG65599",".","1 Unit","Blood products, collected from a donor whose suitability to donate was not adequately determined, were distributed.",11/10/2008,"11/10/2008",1/23/2013,"01/23/2013"
"Biologics",50567,"Terminated","American Red Cross Blood Services","Saint Louis","MO","US","Voluntary: Firm Initiated","Letter","Missouri; California","B-0188-13","Class II","Cryoprecipitated AHF","011GG65599",".","1 Unit","Blood products, collected from a donor whose suitability to donate was not adequately determined, were distributed.",11/10/2008,"11/10/2008",1/23/2013,"01/23/2013"
"Biologics",50567,"Terminated","American Red Cross Blood Services","Saint Louis","MO","US","Voluntary: Firm Initiated","Letter","Missouri; California","B-0189-13","Class III","Blood and Blood Products for Reprocessing","011GG65599",".","1 Unit","Blood products, collected from a donor whose suitability to donate was not adequately determined, were distributed.",11/10/2008,"11/10/2008",1/23/2013,"01/23/2013"
"Biologics",50588,"Terminated","BioLife Plasma Services L.P.","Deerfield","IL","US","Voluntary: Firm Initiated","FAX","CA","B-0206-13","Class II","Source Plasma","06DTXC0849; 06DTXC1189; 06DTXC1646; 06DTXC2014; 06DTXC2293; 06DTXC2628; 06DTXC3411; 06DTXC3766; 06DTXC4035; 06DTXC4390; 06DTXC4690; 06DTXC5204; 06DTXC5270; 06DTXC5765; 06DTXC5861; 06DTXC6363; 06DTXC6450 ;06DTXC7035; 06DTXC7189; 06DTXC7633; 06DTXC7779; 06DTXC8263; 06DTXC8437; 06DTXC8971; 06DTXC9181; 06DTXC9678; 06DTXC9913; 06DTXD0550; 06DTXD0924; 06DTXD1252; 06DTXD1630; 06DTXD1957; 06DTXD2464; 06DTXD2662; 06DTXD2982; 06DTXD3357; 06DTXD3534; 06DTXD4236; 06DTXD4606; 06DTXD5024; 06DTXD5285; 06DTXD5560; 06DTXD5714; 07DTXA0102; 07DTXA0292; 07DTXA0585; 07DTXA0853; 07DTXA1019; 07DTXA1373; 07DTXA2109; 07DTXA2371; 07DTXA2975; 07DTXA3165; 07DTXA3588; 07DTXA4655; 07DTXA4838; 07DTXA5489; 07DTXA5843; 07DTXA5991; 07DTXA6245; 07DTXB0679; 07DTXB0854; 07DTXB1215; 07DTXB1387; 07DTXB2044; 07DTXB2669; 07DTXB2914; 07DTXB4616; 07DTXB4903; 07DTXB5299; 07DTXB5874; 07DTXB6119; 07DTXB6608; 07DTXB6878; 07DTXB7365; 07DTXB8120; 07DTXB8433; 07DTXB8849; 07DTXB9179; 07DTXB9586; 07DTXC0072; 07DTXC0697; 07DTXC0928; 07DTXC5590; 07DTXC5893; 07DTXC6398; 07DTXC7081; 07DTXC7272; 07DTXC7904; 07DTXC8057; 07DTXC8925; 07DTXC9185; 07DTXC9764; 07DTXD0088; 07DTXD0439; 07DTXD0741; 07DTXD1351; 07DTXD2242; 07DTXD2579; 07DTXD3144; 07DTXD3617; 08DTXA0308; 08DTXA0663; 08DTXA1378; 08DTXA1619; 08DTXA2417; 08DTXA3093; 08DTXA3347; 08DTXA4316; 08DTXA4897; 08DTXA5228; 08DTXA5747; 08DTXA5955; 08DTXA7034; 08DTXA7373; 08DTXA8483; 08DTXA8855; 08DTXA9644; 08DTXA9931; 08DTXB0452; 08DTXB0986; 08DTXB1460; 08DTXB1980; 08DTXB2452; 08DTXB3036; 08DTXB4603; 08DTXB5259; 08DTXB6343; 08DTXB6458; 08DTXB7406; 08DTXB7673;08DTXB8366;08DTXD2764;08DTXD4245;08DTXD4951; 08DTXD5241",,"136","Blood products, which were collected from a donor with a history of multiple high risk behaviors, were distributed.",11/21/2008,"11/21/2008",2/13/2013,"02/13/2013"
"Biologics",50590,"Terminated","LifeSouth Community Blood Centers, Inc.","Brooksville","FL","US","Voluntary: Firm Initiated","FAX","Florida","B-1047-13","Class II","Platelets Pheresis Leukocytes Reduced ","72J200838",".","1 unit","Blood product, with a low platelet count, was distributed.",10/24/2008,"10/24/2008",5/1/2013,"05/01/2013"
"Biologics",50591,"Terminated","LifeSouth Community Blood Centers, Inc.","Brooksville","FL","US","Voluntary: Firm Initiated","FAX","Florida","B-1046-13","Class II","Platelets Pheresis Leukocytes Reduced ","72J200513",".","1 unit","Blood product, with a low platelet count, was distributed.",10/24/2008,"10/24/2008",5/1/2013,"05/01/2013"
"Biologics",50593,"Terminated","American National Red Cross (The)","Portland","OR","US","Voluntary: Firm Initiated","Letter","Massachusetts and California.","B-0462-13","Class II","Red Blood Cells Leukocytes Reduced","21FV31979",".","1 component","Blood products, collected from a donor whose suitability to donate was not adequately determined, were distributed. ",10/30/2008,"10/30/2008",1/23/2013,"01/23/2013"
"Biologics",50593,"Terminated","American National Red Cross (The)","Portland","OR","US","Voluntary: Firm Initiated","Letter","Massachusetts and California.","B-0463-13","Class III","Blood and Blood Products for Reprocessing","21FV31979",".","1 component","Blood products, collected from a donor whose suitability to donate was not adequately determined, were distributed. ",10/30/2008,"10/30/2008",1/23/2013,"01/23/2013"
"Biologics",50596,"Terminated","Puget Sound Blood Center and Program","Seattle","WA","US","Voluntary: Firm Initiated","Letter","The recalling firm notified the consignees located in Washington and California by letter dated 11/28/2008. The consignees responded the units have been transfused.","B-0483-13","Class II","Red Blood Cells Leukocytes Reduced","W141608044809; W141608049022.",,"2 units","Blood products, which were collected from a donor who traveled to a malarial endemic area, were distributed.",11/28/2008,"11/28/2008",2/13/2013,"02/13/2013"
"Biologics",50596,"Terminated","Puget Sound Blood Center and Program","Seattle","WA","US","Voluntary: Firm Initiated","Letter","The recalling firm notified the consignees located in Washington and California by letter dated 11/28/2008. The consignees responded the units have been transfused.","B-0484-13","Class II","Platelets Pooled","W141608044809.",,"1 unit","Blood products, which were collected from a donor who traveled to a malarial endemic area, were distributed.",11/28/2008,"11/28/2008",2/13/2013,"02/13/2013"
"Biologics",50608,"Terminated","Talecris Plasma Resources, Inc.","N Las Vegas","NV","US","Voluntary: Firm Initiated","Letter","NC.","B-0500-13","Class III","Source Plasma","037308105, 037308106, 037308107, 037308107A, 037308108, 037308109, 037308109A, 037308114A ",,"8 units","Blood products, which may have been exposed to unacceptable temperatures during storage, were distributed.",9/26/2008,"09/26/2008",2/13/2013,"02/13/2013"
"Biologics",50608,"Terminated","Talecris Plasma Resources, Inc.","Research Triangle Park","NC","US","Voluntary: Firm Initiated","Letter","NC.","B-0500-13","Class III","Source Plasma","037308105, 037308106, 037308107, 037308107A, 037308108, 037308109, 037308109A, 037308114A ",".","8 units","Blood products, which may have been exposed to unacceptable temperatures during storage, were distributed.",9/26/2008,"09/26/2008",3/27/2013,"03/27/2013"
"Biologics",50609,"Terminated","Talecris Plasma Resources, Inc.","N Las Vegas","NV","US","Voluntary: Firm Initiated","Letter","NV.","B-0526-13","Class III","Source Plasma","037307127",,"1 unit","Blood product, which exceeded time allowed for storage and shipping temperatures, was distributed.",9/26/2008,"09/26/2008",2/20/2013,"02/20/2013"
"Biologics",50613,"Terminated","Tacoma-Pierce County Blood Bank","Tacoma","WA","US","Voluntary: Firm Initiated","Letter","The recalling firm notified the Minnesota consignee by letter on 02/02/2006. The consignee responded that the unit was transfused.","B-0802-13","Class II","Red Blood Cells","W127808301997.",".","1 component","Blood product, which was collected from a donor who traveled to a malarial endemic area, was distributed.",11/26/2008,"11/26/2008",3/27/2013,"03/27/2013"
"Biologics",50623,"Terminated","American National Red Cross (The)","West Henrietta","NY","US","Voluntary: Firm Initiated","FAX","NY","B-1627-13","Class II","Red Blood Cells Leukocytes Reduced","01KX94084",".","1 unit","Blood products, in which routine testing interpreted or documented incorrectly, were distributed.",10/30/2008,"10/30/2008",7/17/2013,"07/17/2013"
"Biologics",50623,"Terminated","American National Red Cross (The)","West Henrietta","NY","US","Voluntary: Firm Initiated","FAX","NY","B-1628-13","Class II","Platelets Leukocytes Reduced","01Q20922",".","1 unit","Blood products, in which routine testing interpreted or documented incorrectly, were distributed.",10/30/2008,"10/30/2008",7/17/2013,"07/17/2013"
"Biologics",50629,"Terminated","Florida Blood Services, Inc.","Pensacola","FL","US","Voluntary: Firm Initiated","Telephone","Florida","B-0795-13","Class II","Platelets Pheresis Leukocytes Reduced","W11630879390500 (3 units)",".","3 units","Blood products, for which the quality control testing was not performed, were distributed.",12/7/2008,"12/07/2008",5/1/2013,"05/01/2013"
"Biologics",50630,"Terminated","CSL Plasma Inc","Tempe","AZ","US","Voluntary: Firm Initiated","FAX","IL, CA, Switzerland","B-1673-13","Class II","Source Plasma","0481140752, 0481144544, 0481143405, 0481139746, 0481136797, 0481135692, 0481133547, 0481131926, 0481130470, 0481128779, 0481127338, 0481124821, 0481123835, 0481121841 0481120824, 0481118127, 0481117175, 0481114690, 0481112748, 0481110630, 0481108999, 0481107026, 0481106141, 0481102517, 0481100805, 0481098555, 0481097037, 0481095951, 0481092615, 0481092031, 0481088182, 0481087379, 0481084331, 0481081938, 0481078834, 0481077362, 0481075084, 0481070832, 0481070128, 0481068129, 0481066918, 0481066257, 0481064907, 0481064382, 0481063187, 0481062597, 0481061449, 0481060853, 0481059667, 0481059086, 0481057965, 0481057416, 0481056188, 0481055571, 0481054514, 0481053946, ",".","56 units","Blood products, collected from donors whose scheduled physical examinations were incomplete, were distributed.",11/4/2008,"11/04/2008",7/17/2013,"07/17/2013"
"Biologics",50632,"Terminated","Providence Health System - Southern California","Burbank","CA","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","California","B-1521-13","Class II","Plasma Frozen within 24 hours (FP24)","KL219351",,"1 unit","Blood products, collected from donors, whose suitability to donate was not adequately determined, were distributed.",12/12/2008,"12/12/2008",7/3/2013,"07/03/2013"
"Biologics",50638,"Terminated","Talecris Plasma Resources, Inc.","Research Triangle Park","NC","US","Voluntary: Firm Initiated","FAX","North Carolina","B-1089-13","Class II","Source Plasma","366051639;366053393;366053758;366054269;366055108;366055486;366057062;366058924;366059301;366073292;366073628;366077496",".","12 units","Blood products, collected from a donor who was permanently deferred, were distributed.",7/17/2008,"07/17/2008",5/15/2013,"05/15/2013"
"Biologics",50640,"Terminated","Talecris Plasma Resources, Inc.","Research Triangle Park","NC","US","Voluntary: Firm Initiated","FAX","North Carolina","B-1205-13","Class II","Source Plasma","366069850, 366072511, 366077373",".","3 units","Blood products, collected from a donor with a history of incarceration, were distributed.",11/10/2008,"11/10/2008",5/1/2013,"05/01/2013"
"Biologics",50641,"Terminated","Mississippi Valley Reg Bld Ctr","Davenport","IA","US","Voluntary: Firm Initiated","Telephone","Mississippi","B-0499-13","Class II","Red Blood Cells Leukocytes Reduced","W038308076144",,"1 Unit","Blood product, labeling/crossmatch tag incorrect or missing information was distributed. ",11/4/2008,"11/04/2008",2/13/2013,"02/13/2013"
"Biologics",50643,"Terminated","The American National Red Cross South Carolina Region","Columbia","SC","US","Voluntary: Firm Initiated","Telephone","SC","B-0975-13","Class II","Plasma Frozen","36GL21029",,"1 unit","Blood products, which were collected from a donor in which donor suitability was not adequately determined, were distributed.",11/18/2008,"11/18/2008",4/17/2013,"04/17/2013"
"Biologics",50643,"Terminated","The American National Red Cross South Carolina Region","Columbia","SC","US","Voluntary: Firm Initiated","Telephone","SC","B-0974-13","Class II","Red Blood Cells Leukocytes Reduced","36GL21029",,"1 unit","Blood products, which were collected from a donor in which donor suitability was not adequately determined, were distributed.",11/18/2008,"11/18/2008",4/17/2013,"04/17/2013"
"Biologics",50644,"Terminated","Talecris Plasma Resources, Inc.","Research Triangle Park","NC","US","Voluntary: Firm Initiated","FAX","North Carolina, USA","B-1114-13","Class II","Source Plasma","366065365; 366065430; 366072465; 366074312; 366074666; 366081860; 366082295; 366083644; 366084122; 366088258; 366088678; 366090707; 366094116; 366094786; 366095612; 366096515; 366097322; 366098286; 366100123; 366100862; 366101853; 366102646; 366104664; 366104927; 366116229; 366120216; 366120573; 366121478; 366121828; 366123272; 377127087",,"31 units","Blood products, collected from a donor who received a body piercing within 12 months of donation, were distributed.",11/14/2008,"11/14/2008",5/22/2013,"05/22/2013"
"Biologics",50646,"Terminated","Mercy Medical Center Blood Bank","Springfield","MA","US","Voluntary: Firm Initiated","FAX","MA","B-0307-13","Class III","Red Blood Cells Leukocytes Reduced","93GC07180; 93GC07182; 93GC07183; 93GC07184; 93GC07186",".","5 units","Blood products, collected using a machine for which quality control testing was not performed, were distributed",12/4/2008,"12/04/2008",1/2/2013,"01/02/2013"
"Biologics",50651,"Terminated","Mississippi Valley Reg Bld Ctr","Davenport","IA","US","Voluntary: Firm Initiated","Letter","Missouri","B-0498-13","Class II","Red Blood Cells Leukocytes Reduced","W038308075650",,"1 Unit","Blood product, which did not meet the acceptable product specifications, was distributed.",12/11/2008,"12/11/2008",2/13/2013,"02/13/2013"
"Biologics",50656,"Terminated","Talecris Plasma Resources, Inc.","Research Triangle Park","NC","US","Voluntary: Firm Initiated","FAX","North Carolina","B-1665-13","Class II","Source Plasma","366027304, 366026831, 366025874, 366025391, 366024924, 366024530, 366024101, 366023644, 366023243, 366022718, 366022200, 366021598, 366021268, 366020655, 366020302, 366019234, 366018953, 366018335, 366017996, 366017369, 366017045, 366015267, 366014368, 366014020, 366013394, 366013081, 366010974, 366010638, 366009925, 366009630, 366005720, 366005669,",".","32 units","Blood products, collected from a donor with a history of incarceration, were distributed.",11/13/2008,"11/13/2008",7/24/2013,"07/24/2013"
"Biologics",50659,"Terminated","Talecris Plasma Resources, Inc.","Research Triangle Park","NC","US","Voluntary: Firm Initiated","FAX","North Carolina","B-1196-13","Class II","Source Plasma","366089959; 366089995",,"2 units","Blood products, collected from a donor who received a tattoo within 12 months of donation, were distributed.",11/10/2008,"11/10/2008",5/22/2013,"05/22/2013"
"Biologics",50662,"Terminated","Talecris Plasma Resources, Inc.","Research Triangle Park","NC","US","Voluntary: Firm Initiated","FAX","North Carolina","B-0044-13","Class II","Source Plasma","I52016184, I52016394, I52018262, I52018570, I52018970, I52019242, I52019495, I52019724, I52022606, I52020929, I52021091, I52021531, I52021688",".","13 units","Blood products, collected from a donor who was at risk for variant Creutzfeldt-Jakob Disease (vCJD), were distributed.",11/3/2008,"11/03/2008",1/16/2013,"01/16/2013"
"Biologics",50668,"Terminated","Talecris Plasma Resources, Inc.","Colorado Springs","CO","US","Voluntary: Firm Initiated","FAX","North Carolina","B-0041-14","Class II","Source Plasma","366000791;366000843",".","2 units","Blood products, collected from a donor who was previously deferred, were distributed.",11/3/2008,"11/03/2008",12/4/2013,"12/04/2013"
"Biologics",50671,"Terminated","Puget Sound Blood Center and Program","Seattle","WA","US","Voluntary: Firm Initiated","Letter","Washington","B-0219-13","Class II","Red Blood Cells","W141608653413",".","1 unit","Blood product, collected from a donor who traveled to an area considered endemic for malaria, was distributed.",11/28/2008,"11/28/2008",1/16/2013,"01/16/2013"
"Biologics",50672,"Terminated","Puget Sound Blood Center and Program","Seattle","WA","US","Voluntary: Firm Initiated","Letter","Washington","B-0217-13","Class II","Red Blood Cells Leukocytes Reduced Irradiated","W141608253881",".","1 unit","Blood products, collected from a donor who traveled to an area considered endemic for malaria, were distributed.",11/28/2008,"11/28/2008",1/16/2013,"01/16/2013"
"Biologics",50672,"Terminated","Puget Sound Blood Center and Program","Seattle","WA","US","Voluntary: Firm Initiated","Letter","Washington","B-0216-13","Class II","Platelets Pooled","W141608253881",".","1 unit","Blood products, collected from a donor who traveled to an area considered endemic for malaria, were distributed.",11/28/2008,"11/28/2008",1/16/2013,"01/16/2013"
"Biologics",50673,"Terminated","Lane Memorial Blood Bank","Eugene","OR","US","Voluntary: Firm Initiated","Letter","Oregon.","B-0954-13","Class II","Red Blood Cells Leukocytes Reduced","W137508106942; W137508109801",".","2 ","Blood products, collected from a donor who reported travel to a malarial endemic area, were distributed.",12/18/2008,"12/18/2008",4/24/2013,"04/24/2013"
"Biologics",50674,"Terminated","Florida's Blood Centers, Inc.","Orlando","FL","US","Voluntary: Firm Initiated","E-Mail","Austria","B-1045-13","Class II","Fresh Frozen Plasma","6333195",".","1 unit","Blood product, collected from a donor who was at risk for variant Creutzfeldt-Jakob Disease (vCJD), was distributed.",12/19/2008,"12/19/2008",5/1/2013,"05/01/2013"
"Biologics",50675,"Terminated","BioLife Plasma Services LP","Joplin","MO","US","Voluntary: Firm Initiated","FAX","CA","B-1623-13","Class II","Source Plasma","08JMOH6315; 08JMOH5467 ",,"2 units","Blood products, collected from a donor who received a tattoo within 12 months of donation, were distributed.",12/15/2008,"12/15/2008",7/3/2013,"07/03/2013"
"Biologics",50715,"Terminated","Community Blood Bank, Inc.","Rancho Mirage","CA","US","Voluntary: Firm Initiated","FAX","California","B-2404-13","Class II","Red Blood Cells Leukocytes Reduced","W051408112578",,"1 unit","Blood product, collected from a donor who traveled to an area considered endemic for malaria, was distributed.",12/11/2008,"12/11/2008",11/6/2013,"11/06/2013"
"Biologics",50716,"Terminated","Central Kentucky Blood Center, Inc.","Lexington","KY","US","Voluntary: Firm Initiated","Letter","Kentucky","B-2201-13","Class II","Red Blood Cells Leukocytes Reduced","2505947(Part B); 2505947(Part A)",,"2 units","Blood products, which were collected from a donor who traveled to a malarial endemic area, were distributed.",12/11/2008,"12/11/2008",9/4/2013,"09/04/2013"
"Biologics",50720,"Terminated","LifeServe Blood Center","Des Moines","IA","US","Voluntary: Firm Initiated","Letter","Iowa, Pennsylvania, Switzerland","B-0807-13","Class III","Plasma Frozen","W037908133161;LX68719",,"2 Units","Blood products, collected from a donor taking the medication Enbrel, were distributed.",12/15/2008,"12/15/2008",4/3/2013,"04/03/2013"
"Biologics",50720,"Terminated","LifeServe Blood Center","Des Moines","IA","US","Voluntary: Firm Initiated","Letter","Iowa, Pennsylvania, Switzerland","B-0808-13","Class III","Blood and Blood Products for Reprocessing","LF42976",,"1 Unit","Blood products, collected from a donor taking the medication Enbrel, were distributed.",12/15/2008,"12/15/2008",4/3/2013,"04/03/2013"
"Biologics",50720,"Terminated","LifeServe Blood Center","Des Moines","IA","US","Voluntary: Firm Initiated","Letter","Iowa, Pennsylvania, Switzerland","B-0806-13","Class III","Red Blood Cells","LX68719",,"1 Unit","Blood products, collected from a donor taking the medication Enbrel, were distributed.",12/15/2008,"12/15/2008",4/3/2013,"04/03/2013"
"Biologics",50720,"Terminated","LifeServe Blood Center","Des Moines","IA","US","Voluntary: Firm Initiated","Letter","Iowa, Pennsylvania, Switzerland","B-0805-13","Class III","Red Blood Cells Leukocytes Reduced","W037908133161;LF42976",,"2 Units","Blood products, collected from a donor taking the medication Enbrel, were distributed.",12/15/2008,"12/15/2008",4/3/2013,"04/03/2013"
"Biologics",50723,"Terminated","LifeServe Blood Center","Des Moines","IA","US","Voluntary: Firm Initiated","Telephone","Iowa","B-1265-13","Class III","Red Blood Cells","W037908102316",".","1 Unit","Blood product, collected from a donor, whose suitability to donate was not adequately determined, was distributed.",12/2/2008,"12/02/2008",6/12/2013,"06/12/2013"
"Biologics",50729,"Terminated","Talecris Plasma Resources, Inc.","Pueblo","CO","US","Voluntary: Firm Initiated","FAX","NC","B-2022-13","Class III","Source Plasma","369064209, 369063313, 369058837, 369055711, 369052861, 369049176, 369046178, 369044704, 369044083, 369043645, 369042531, 369038854, 369038538, 369035560, 369034111, 369033744, 369031692, 369030018, 369062633, 369058303, 369057991, 369056564, 369055199, 369054911, 369051175, 369049864, 369048936, 369044066, 369043558, 369043059, 369041724, 369037201, 369036706, 369035761, 369032590, 369032117, 369030772, 369063814, 369062548, 369059113, 369053363, 369047074, 369044580, 369039010, 369033116, 369031011, 369061941, 369058142, 369055445, 369054882, 369044578, 369041832, 369041550, 369037947, 369037276, 369034601, 369034253, 369060110, 369054261, 369054012, 369052672, 369052223, 369051764, 369049733, 369047123, 369046978, 369046206, 369044815, 369042763, 369041083, 369040127, 369038849, 369036999, 369036029, 369031920, 369030115, 369064033, 369061651, 369054369, 369053507, 369052829, 369048997, 369050504, 369046189, 369043086, 369042797, 369042173, 369041180, 369039525, 369038891, 369036843, 369035238, 369044845, 369041138, 369039946, 369035424, 369035409, 369030055, 369029126, 369044164, 369039613, 369034025, 369034478, 369033179, 369031058, 369030497, 369036404, 369035957, 369034969, 369031424, 369031030, 369030179, 369032583, 369031673, 369029467, 369044773, 369044549, 369042931, 369039096, 369032658, 369031737, 369030803, 369029031, 369042919, 369041372, 369040106, 369039188, 369038133, 369037622, 369037192, 369040400, 369038406, 369037649, 369033301, 369039991, 369038168, 369034792, 369034313, 369033390, 369032973, 369032043, 369040707, 369040374, 369039458, 369038832, 369038350, 369032947, 369031423, 369031050, 369030366, 369030214, 369028825, 369043336, 369039266, 369031682, 369031056, 369033341, 369033733, 369032173, 369037740, 369031675, 369030386, 369033131, 369032201, 369031115, 369044482, 369037860, 369037620, 369037043, 369033701, 369031039, 369030188, 369031872, 369030924, 369030084, 369028655, 369028997, 369030609, 369030318, 369036178, 369035524, 369029216, 369028923, 369035342, 369036456, 369034679,",,"1610 units","Blood products, collected from a donor in which donor suitability was not adequately determined, were distributed.",6/15/2007,"06/15/2007",8/21/2013,"08/21/2013"
"Biologics",50735,"Terminated","Talecris Plasma Resources, Inc.","Research Triangle Park","NC","US","Voluntary: Firm Initiated","FAX","North Carolina","B-1151-13","Class II","Source Plasma","366056293, 366056318, 366085316",".","3 units","Blood products, collected from a donor with a history of intravenous drug use, were distributed.",11/10/2008,"11/10/2008",5/1/2013,"05/01/2013"
"Food",50900,"Completed","Tropical Nut & Fruit Inc","Columbus","OH","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","The recalled product was sold in Tropical's Outlet Store in Columbus, OH.","F-1037-2013","Class I","Granulated Peanuts in 1 lb plastic bags.","Lot #'s 8148B, 8168B, 8288B & 8289B",,"390/1 lb bags and 416/30 lb cases","The product is being recalled because it was manufactured using peanut products recalled by Peanut Corporation of America because it has the potential to be contaminated with Salmonella.",1/30/2009,"01/30/2009",3/13/2013,"03/13/2013"
"Biologics",50951,"Terminated","American National Red Cross (The)","Cleveland","OH","US","Voluntary: Firm Initiated","Telephone","Ohio, California.","B-0584-13","Class II","Red Blood Cells Leukocytes Reduced","42 FZ34322, 42 FZ34323, 42 FZ34325, 42 FZ34328, 42 FY90934, 42 FY90942, 42 FY90943, 42 FY90947, 42 FY90954, 42 FY90990, 42 FY90993, 42 G76618, 42 G76631, 42 G76632, 42G 76644, 42 G 76646, 42 R05856, 42 R05859, 42 R 05863, 42 R05872, 42 R05877, 42 R05880, 42 K06759, 42 K06764, 42K06775, 42K06777, 42 K06781, 42 K06794, 42 FR54630, 42 S41166, 42 S41235, 42 S41239, 42 S41242, 42 S41247, 42 FG41438",,"35 units","Blood products, which were collected without applying the metal crimp and potentially cause contamination to the blood, were distributed.",12/4/2008,"12/04/2008",3/20/2013,"03/20/2013"
"Biologics",50951,"Terminated","American National Red Cross (The)","Cleveland","OH","US","Voluntary: Firm Initiated","Telephone","Ohio, California.","B-0587-13","Class II","Platelets Pooled Leukocytes Reduced","25612, 25600,25607, 25634, 25694, 25713, 25731, 25781, 25938, 26009, 26036",,"11 units","Blood products, which were collected without applying the metal crimp and potentially cause contamination to the blood, were distributed.",12/4/2008,"12/04/2008",3/20/2013,"03/20/2013"
"Biologics",50951,"Terminated","American National Red Cross (The)","Cleveland","OH","US","Voluntary: Firm Initiated","Telephone","Ohio, California.","B-0586-13","Class II","Platelets Leukocytes Reduced","42 FY90992, 42 FY90993, 42 R05863, 42 R05877, 42R05880, 42 S41235, 42 S41239, 42 S41247, 42 K06775, 42 K06777, 42 K06794, 42FH67049",,"12 units","Blood products, which were collected without applying the metal crimp and potentially cause contamination to the blood, were distributed.",12/4/2008,"12/04/2008",3/20/2013,"03/20/2013"
"Biologics",50954,"Terminated","Talecris Plasma Resources, Inc.","Research Triangle Park","NC","US","Voluntary: Firm Initiated","FAX","North Carolina","B-0205-13","Class II","Source Plasma","366114186, 366112717, 366111503, 366113827, 366110539, 366110229, 366109212, 366102779, 366101468, 366100729, 366099619, 366098290, 366096881, 366096418, 366094371, 366093295, 366091439, 366091305, 366087915, 366087494, 366086570, 366084819, 366084594, 366083584, 366083319, 366081603, 366081414, 366080176, 366079795, 366077808, 366077428, 366076904, 366075364, 366074966, 366074174, 366073803, 366073008, 366072170, 366071460, 366071145, 366070369, 366068705, 366068050, 366067625, 366065135, 366065088, 366049285, 366048534, 366048220, 366047767, 366046406, 366045572, 366044844, 366044738, 366043964, 366043723, 366043313, 366042910, 366042564, 366041779, 366041598, 366040691, 366040325, 366039315, 366038536, 366037633, 366037133, 366036815, 366036174, 366036017, 366034409, 366034140, 366032820, 366032471, 366031837, 366031504, 366030946, 366030561, 366030071, 366029625, 366029090, 366028713, 366028238, 366027747, 366027321, 366026861, 366025865, 366025246, 366024526, 366024038, 366023589, 366023138, 366022682, 366022179, 366021714, 366021250, 366020842, 366020279, 366019308, 366018970, 366018247, 366017925, 366016988, 366016619, 366015248, 366014789, 366014164, 366013846, 366013044, 366010830, 366010513, 366009717, 366009311, 366008834, 366008231, 366007661, 366007316, 366006344, 366005384, I52062487, I52062224, I52061675, I52061454, I52060803, I52060608, I52059995, I52059786, I52058636, I52058376, I52057692, I52057317, I52048664, I52048466, I52047404, I52047110, I52046647, I52046418, I52043742, I52043708,366111027",".","139 units","Blood products, which were collected from a donor in which donor suitability was not adequately determined, were distributed.",6/30/2008,"06/30/2008",1/16/2013,"01/16/2013"
"Biologics",50955,"Terminated","Talecris Plasma Resources, Inc.","Research Triangle Park","NC","US","Voluntary: Firm Initiated","FAX","North Carolina","B-1153-13","Class II","Source Plasma","366095677, 366094688, 366109073, 366107543, 366107315, 366106233, 366106003, 366104771, 366104526, 366102976, 366102501, 366101455, 366100945, 366100044, 366099310, 366098093, 366097216, 366096086 366094109, 366092688, 366091966, 366090927, 366090559, 366089066, 366088579, 366082046, 366081661, 366080530, 366080016, 366077973, 366077659, 366075300, 366072799",".","33 units","Blood products, collected from a donor with a history of hepatitis, were distributed.",11/4/2008,"11/04/2008",5/1/2013,"05/01/2013"
"Biologics",50956,"Terminated","Talecris Plasma Resources, Inc.","Research Triangle Park","NC","US","Voluntary: Firm Initiated","FAX","North Carolina","B-1106-13","Class II","Source Plasma","366079288; 366079360; 366082135; 366083179; 366084190; 366084634; 366085317; 366087202; 366087644; 366088694; 366089200; 366090702; 366091164; 366092335; 366093126; 366094294; 366095581; 366096218; 366085779, 366097224, 366097722, 366099231, 366099613, 366100689, 366101179, 366105600, 366107419, 366108864, 366109940, 366110474, 366111772, 366114206, 366121907, 366122282 ",,"34 units","Blood products, collected from a donor who was not asked follow-up questions regarding increased risk for vCJD, were distributed. ",11/3/2008,"11/03/2008",5/8/2013,"05/08/2013"
"Biologics",50957,"Terminated","Talecris Plasma Resources, Inc.","Research Triangle Park","NC","US","Voluntary: Firm Initiated","FAX","North Carolina","B-0978-13","Class II","Source Plasma","I52036026;I52036120;I52037633;I52037894;I52038291;I52038528;I52038925;I52039319;I52041067;I52041878;I52042096;I52042895;I52043139;I52044589;I52044752;I52045480;I52045753;I52046240",,"18 units","Blood products, collected from a donor who was permanently deferred, were distributed.",11/10/2008,"11/10/2008",4/17/2013,"04/17/2013"
"Biologics",50959,"Terminated","Talecris Plasma Resources, Inc.","Research Triangle Park","NC","US","Voluntary: Firm Initiated","FAX","North Carolina","B-1055-13","Class II","Source Plasma","I52056587, I52056623, I52058423, I52060172, 366039929, 366046528, 366048801, 366049748, 366050083, 366051209, 366052441, 366052751, 366053373, 366053709, 366055716, 366057218, 366056696, 366057880, 366058229, 366059229, 366061240, 366061493, 366071160",".","23 units","Blood products, collected from a donor who may have received a piercing within 12 months of donation, were distributed.",11/10/2008,"11/10/2008",5/1/2013,"05/01/2013"
"Biologics",50960,"Terminated","Talecris Plasma Resources, Inc.","Research Triangle Park","NC","US","Voluntary: Firm Initiated","FAX","North Carolina","B-1207-13","Class II","Source Plasma","366000991, 366005544, 366008266, 366008731, 366009103, 366009671, 366010025, 366013699, 366014876, 366015158, 366017393, 366017691, 366018363, 366020303, 366020669, 366023789, 366025305, 366025629, 366027257, 366046828, 366046841, 366050624, 366050914, 366052261, 366052913, 366053174, 366053818, 366057036, 366057382, 366057888, 366058440, 366061219, 366062422, 366065707, 366065872, 366066685, 366066921, 366067657, 366070287, 366074385, 366094167, 366096751, 366097578, 366101130, 366102652",".","45 units","Blood products, collected from a donor who was at risk for variant Creutzfeldt-Jakob Disease (vCJD), were distributed.",11/3/2008,"11/03/2008",5/1/2013,"05/01/2013"
"Biologics",50961,"Terminated","Talecris Plasma Resources, Inc.","Research Triangle Park","NC","US","Voluntary: Firm Initiated","FAX","NC","B-1206-13","Class II","Source Plasma","366110839, 366110625, 366109647, 366109272, 366106529, 366106118, 366105009, 366104617, 366103734, 366102863, 366099589, 366098121, 366097683, 366096390, 366094812, 366094325, 366092732, 366091927, 366091241, 366090522, 366088549, 366088087, 366086766, 366086560, 366084873, 366084732, 366083204, 366082379, 366081382, 366081043, 366080100, 366079694, 366077702, 366077317, 366078024, 366076637, 366075217, 366074568, 366073986, 366073459, 366072235, 366071810, 366070249, 366069409, 366068692, 366068418, 366067301, 366066951, 366066312, 366065802, 366064557, 366064232, 366063547, 366062890, 366062597, 366061850, 366061582, 366060453, 366060046, 366059468, 366059047, 366058398, 366058068, 366056805, 366057432, 366055621, 366055247, 366054812, 366053923, 366053575, 366053048, 366052677, 366052174, 366051260, 366050698, 366050490, 366049830, 366049587, 366048846, 366048403, 366048110, 366047154, 366046423, 366045810, 366045589, 366044983, 366044800, 366040510, 366039108, 366038922, 366038025, 366037765, 366033634, 366032499, 366030731, 366030139, 366020494, 366020432, 366018937, 366108601, 366017894, 366017310, 366010757, 366010484, 366000946, 366009577, 366008945, 366008710, 366008059, 366007863, 366006311, 366005143, 366004761, 366004267, 366003909, 366003199, 366003027, 366002375, 366002233, 366001413, 366001283, 360000005, I52063497, I52062777, I52062736, I52061953, I52061640, I52061131, I52060871, I52060293, I52058949, I52058063, I52057847, I52057048, I52056279, I52055707, I52055437, I52054825, I52054589, I52053877, I52051737, I52051666, 366113238, 366113455, 366111850, 366112754, 366114692, 366114918, 366115846, 366116186, 366123412 ",".","151 units","Blood products, collected from a donor with a history of high-risk behavior, were distributed.",11/4/2008,"11/04/2008",5/1/2013,"05/01/2013"
"Biologics",50962,"Terminated","Talecris Plasma Resources, Inc.","Research Triangle Park","NC","US","Voluntary: Firm Initiated","FAX","North Carolina,","B-1459-13","Class II","Source Plasma","366077838; 366077363; 366076492; 366076083; 366074795; 366074433; 366073595; 366073096; 366071126; 366070839; 366070127; 366069292; 366068555; 366068208; 366067498; 366066997; 366066040; 366064884; 366064436, 366063804, 366063445, 366060234, 366057905, 366056671, 366057334, 366055693, 366055416, 366054835, 366054477, 366053890, 366053472, 366052557, 366052268, 366051246, 366050829, 366050326, 366049878, 366049488, 366048910, 366048223, 366048009, 366047444, 366047134, 366046093, 366045625, 366045275, 366043658, 366043127, 366042908, 366042354, 366042094, 366041345, 366041079, 366040214, 366039325, 366038783, 366037713, 366036746, 366036350, 366035933, 366034841, 366034165, 366033631, 366032722, 366032218, 366031202, 366030834, 366029992, 366029461, 366028909, 366028559, 366027702, 366027089, 366026752, 366025675, 366025341, 366024755, 366024431, 366023171, 366022968, 366022201, 366022010, 366021278, 366021053, 366018516, 366017886, 366017414, 366007988, 366007432, 366006174, 366004787, 366004436, 366003052, 366002872, 366002234, 366000337, I52062580, I52062053, I52058566, I52058260, I52057443, I52050104, I52049746, I52049432, I52049115, I52048690, I52047043, I52046537, I52046099, I52045791, I52045346, I52045038, I52044626, I52043373, I52042994, I52042477, I52041781, I52041630, I52039185, I52038988, I52038466, I52038344, I52037841, I52037696, I52037171, I52037048, I52035433, I52035284, I52033269, I52032896, I52032655, I52031791, I52031558, I52031174, I52030936, I52029975, I52029797, I52029325, I52028048, I52025937",,"140","Blood products, collected from a donor who was deferred due to risk for variant Creutzfeldt-Jakob Disease (vCJD), were distributed.",11/3/2008,"11/03/2008",6/26/2013,"06/26/2013"
"Biologics",51265,"Terminated","American National Red Cross (The)","Dedham","MA","US","Voluntary: Firm Initiated","Telephone","MA, ME, NH, NY, PA","B-0337-13","Class III","Platelets Pheresis Leukocytes Reduced ","004FG06532, 004FG06535, 004FP94622, 004FP94623, 004FP94626, 004FP94628, 004FP94630, 004GC27533, 004FG06537 (Parts 1 & 2), 004FH06061 (Parts 1, 2, & 3), 004FH06063 (Parts 1 & 2), 004FP94620 (Parts 1 & 2), 004FP94627 (Parts 1, 2, & 3), 004FP94629 (Parts 1 & 2), 004FP94631 (Parts 1 & 2)",".","24 units","Blood products, which were incorrectly tested for human T-lymphotropic virus (HTLV), were distributed.",11/1/2008,"11/01/2008",2/6/2013,"02/06/2013"
"Biologics",51265,"Terminated","American National Red Cross (The)","Dedham","MA","US","Voluntary: Firm Initiated","Telephone","MA, ME, NH, NY, PA","B-0336-13","Class III","Platelets Pheresis Leukocytes Reduced Irradiated","004FG06539 (Parts 1 & 2), 004FH06057 (Parts 1 & 2), 004FP94622 (Parts 1 & 2), 004FP94628, 004FP94631",".","8 units","Blood products, which were incorrectly tested for human T-lymphotropic virus (HTLV), were distributed.",11/1/2008,"11/01/2008",2/6/2013,"02/06/2013"
"Biologics",51265,"Terminated","American National Red Cross (The)","Dedham","MA","US","Voluntary: Firm Initiated","Telephone","MA, ME, NH, NY, PA","B-0335-13","Class III","Red Blood Cells Leukocytes Reduced ","004E25855, 004E25857, 004E25868, 004F77410, 004F77419, 004F77468, 004FJ44301, 004FJ44308, 004J10538, 004J10546, 004M56906 ",".","11 units","Blood products, which were incorrectly tested for human T-lymphotropic virus (HTLV), were distributed.",11/1/2008,"11/01/2008",2/6/2013,"02/06/2013"
"Biologics",51265,"Terminated","American National Red Cross (The)","Dedham","MA","US","Voluntary: Firm Initiated","Telephone","MA, ME, NH, NY, PA","B-0334-13","Class III","Red Blood Cells Leukocytes Reduced Irradiated","004E25878, 004E25879, 004F77446, 004FJ44307, 004FJ44310, 004J10528, 004J10531, 004N71839, 004N71842, 004N71862, 004N71866, 004N71867, 004N71875",".","13 units","Blood products, which were incorrectly tested for human T-lymphotropic virus (HTLV), were distributed.",11/1/2008,"11/01/2008",2/6/2013,"02/06/2013"
"Biologics",51354,"Terminated","Talecris Plasma Resources, Inc.","Research Triangle Park","NC","US","Voluntary: Firm Initiated","FAX","NC","B-0911-13","Class II","Source Plasma","366062470; 366062795; 366063446; 366064187; 366064521; 366065712; 366066099; 366066772; 366067065; 366067722; 366068450; 366068703; 366076202; 366076635; 366080733; 366081890; 366083409; 366084655; 366090123; 366091038; 366091463; 366092776; 366093045; 366095359; 366095840; 366097361; 366098260; 366099750; 366100248",".","29 units","Blood products collected from a donor whose scheduled physical exam had not been performed, were distributed.",2/5/2009,"02/05/2009",4/24/2013,"04/24/2013"
"Biologics",51360,"Terminated","CSL Plasma Inc","Boca Raton","FL","US","Voluntary: Firm Initiated","Letter","nationwide","B-1703-13","Class II","Source Plasma","0481168670; 0481164626; 0481162229; 0481151092; 0481149193; 0481147587; 0481142478; 0481135217; 0481133655 0481132172; 0481129937; 0481127849; 0481126845; 0481124261; 0481123369; 0481118863; 0481117754; 0481115886; 0481114916; 0481108353; 0481106858; 0481105016; 0481104035; 0481102241; 0481101556; 0481099665; 0481098882; 0481078512; 0481064959; 0481058585; 0481057630; 0481056877; 0481055904; 0481052197; 0481050378; ",,"35","Blood products, collected from a donor whose routine physical examination was inadequately documented, were distributed.",1/13/2009,"01/13/2009",7/3/2013,"07/03/2013"
"Biologics",51366,"Terminated","Biomat USA, Inc.","Los Angeles","CA","US","Voluntary: Firm Initiated","Letter","California, Spain, and Japan.","B-0464-13","Class II","Source Plasma","0130050140, 0130050770, 0130051035, 0130051507, 0130051813, 0130052248, 0130052469, 0130052924, 0130053200, 0130053717 0130053996, 0130054472, 0130054718, 0130055393, 0130055563 0130056309, 0130056624, 0130057132, 0130060275, 0130060649 0130057551, 0130058315, 0130058656, 0130059009, 0130061052, 0130061496, 0130061916, 0130062474, 0130062881 ",".","29 components","Blood products, collected from a donor who received a tattoo within 12 months of donating, were distributed.",12/31/2008,"12/31/2008",2/27/2013,"02/27/2013"
"Biologics",51461,"Terminated","Talecris Plasma Resources, Inc.","Research Triangle Park","NC","US","Voluntary: Firm Initiated","FAX","NC","B-0912-13","Class III","Source Plasma","366069668; 366069758; 366073001; 366073218; 366074209; 366074669; 366076781; 366078067; 366077956; 366078753; 366080353; 366080627; 366090190; 366090845; 366091600; 366092375; 366093080; 366094375; 366095054; 366095887; 366096690; 366097611; 366098270; 366099479; 366100192; 366100940; 366101921; 366102505; 366103910; 366104561; 366105398; 366106316; 366107116; 366107615; 366108885; 366109347; 366110249; 366110696; 366113832; 366113299; 366111436.",".","41 units","Blood products collected from a donor who was previously deferred for unsuitable lab test results, were distributed.",1/29/2009,"01/29/2009",4/24/2013,"04/24/2013"
"Biologics",51464,"Terminated","American Red Cross Blood Services","Saint Louis","MO","US","Voluntary: Firm Initiated","FAX","Multiple states within the U.S. Firm could not provide specifics.","B-2056-13","Class II","Plasma Frozen","KS26450; KS32618; KS26812 ;KS26795; KS27370; KS27371; KS27883; KS30126 ;KS26778; KS26831; KS31365; KS30245; KS26824; KS31331; KS26776; KS26787; KS26788 ;KS26791; KS26850; KS26852; FG10087; KS32472; KS32625",".","23 Units","Blood products, possibly contaminated with air during collection, were distributed.",2/2/2009,"02/02/2009",10/2/2013,"10/02/2013"
"Biologics",51464,"Terminated","American Red Cross Blood Services","Saint Louis","MO","US","Voluntary: Firm Initiated","FAX","Multiple states within the U.S. Firm could not provide specifics.","B-2057-13","Class II","Plasma Frozen Cryo Reduced","KS31255; FZ85831; KS31581; KS32483; KS32655; KS36252; KS32652; KS32538; KS32530; KS32547; FX20623; KS28912; KS29917; KS32635; KS27597; KS27917; FX20723; KS28903; KS30221; KS30217; FZ85566; KS31545; KS31543; KS31553; KS30131; KS32532; KS32597; KS31562; KS31546; KS32253; KS31860; KS31557; KS31651; KS32255; KS30140; KS30222; FZ85830; KS31238 ",".","38 Units","Blood products, possibly contaminated with air during collection, were distributed.",2/2/2009,"02/02/2009",10/2/2013,"10/02/2013"
"Biologics",51464,"Terminated","American Red Cross Blood Services","Saint Louis","MO","US","Voluntary: Firm Initiated","FAX","Multiple states within the U.S. Firm could not provide specifics.","B-2055-13","Class II","Red Blood Cells","KS32438; KS32530; KS32527; KX17484; KX17483; KX17479; KX17475; KX17468; KX17467; KX17464; KS32596; KS32597; KS32598; KS32601; KS32610; KS32595; KS32604; KS32629; KS32628; KS32626; KS32624; KS32621; KS32643; KS32632; KS32642; KS32552; KS32528; KS32553; KS32658; KX17465; KX17470; KS32638; KS32582; KS32607; KS32654; FG12509; KS32635; KS32531; KS32604; KS32610; KS32519; KS32643; KX17454; KX17457; KX17461 ",".","45 Units","Blood products, possibly contaminated with air during collection, were distributed.",2/2/2009,"02/02/2009",10/2/2013,"10/02/2013"
"Biologics",51464,"Terminated","American Red Cross Blood Services","Saint Louis","MO","US","Voluntary: Firm Initiated","FAX","Multiple states within the U.S. Firm could not provide specifics.","B-2054-13","Class II","Red Blood Cells Leukocytes Reduced","KS31583; KS32243; KS32648; GF62856; KS26788; KS26831; KS26878; KS26880; KS26895; KS27908; KS27987; KS30757; KS32556",".","13 Units","Blood products, possibly contaminated with air during collection, were distributed.",2/2/2009,"02/02/2009",10/2/2013,"10/02/2013"
"Biologics",51464,"Terminated","American Red Cross Blood Services","Saint Louis","MO","US","Voluntary: Firm Initiated","FAX","Multiple states within the U.S. Firm could not provide specifics.","B-2058-13","Class II","Cryoprecipitated AHF","FZ85867; KS31542; KS31546; KS31548; KS29887; KS31562; KS29999; KS29996; KS30008; KS30162; KS32397; KS32434; KS32442; FZ85860; KS32453; KS32476; KS32495; KS32439; KS32456; KS32455; KS32448; KS32457; KS32608; FX20688; FX20623; FX20672; FX20739; KS27597; KS27618; KS27604; KS27609; GJ87542; KS27803; KS27919; KS27989; KS27987; FG07159; FG07161; KS30000; KS30214; KS30217; KS30819; KS31047; GG54598; GG54596; KS32653; KS31129; KS32680; KS32657; KS27376; GG64591; KS28900; KS28905; KS28912; KS30004; KS30135; KS30222; KS31238; KS31255; KS31554; KS31561; KS32435; KS32451; KS32604; KS32607; KS32652; KS32632; KS32635; KS27619; KS27602; FL65947; KB27889; KS28813; KS2816; FZ85866; KS31451; FZ85830; KS32393; KS32498; KS32492; KS32568; KS32549; FX20670; KS27614; KS30959; KS31133; FZ85855; KS32542; GJ87649; GJ87625; GJ87548; KS29998; KS32556; KS30002; KS30140; KS30144; KS30221; KS30219; KS32398; KS32440; KS30131; KS32392; KX17478; KX17475; KS32637; KS32640; KS32643; KS28911; KS32648; KS32441; KS27591; KS27596; KS27816; FG07165; KS27592; KS28917; KS28903; KS27585; KS27605; KS32533; KS32630; KS32654; KS27908; FL56930; KS27917; KS32432; KS32482; KX17477; KX17473; KX17470; KS30008; KS31451; FZ85830; KS32383; KS32485; KS32498; KS32492; KS32558; KS32549; FL58955; KS27892; KS27908; KS30214; KS32442 ",".","145 Units","Blood products, possibly contaminated with air during collection, were distributed.",2/2/2009,"02/02/2009",10/2/2013,"10/02/2013"
"Biologics",51468,"Terminated","Talecris Plasma Resources, Inc.","Research Triangle Park","NC","US","Voluntary: Firm Initiated","FAX","NC","B-0650-13","Class II","Source Plasma","357109561; 357109081; 357107957; 357107354; 357106112; 357105645; 357104501; 357103958; 357102687; 357094085; 357093564; 357092426; 357091898; 357088997; 357088620; 357087454; 357086940; 357085683; 357085329; 357084251; 357083744; 357082438; 357082275; 357079741; 357079241; 357069722; 357069025; 357067946; 357078368; 357077347; 357076795; 357075138; 357073684; 357073023; 357071708; 357071129; 357070173; 357067075; 357065733; 357065067; 357063857; 357063168; 357061847; 357061391; 357060172; 357059540; 357058141; 357057634; 357056451; 357053823; 357052475; 357051952; 357035559; 357034481; 357034101; 357032979; 357032189; 357032103; 357110528; 357109873; 357107140; 357106296; 357103735; 357102870; 357101841; 357101557; 357100375; 357099094; 357098357; 357097748; 357096607; 357095849; 357095093; 357094461; 357093271; 357092588; 357091765; 357091125; 357089884; 357089236; 357088373; 357087824; 357085970; 357085476; 357084246; 357083805; 357079589; 357079041; 357069225; 357068756; 357067668; 357078158; 357077103; 357076502; 357075340; 357074393; 357066473; 357065819; 357064887; 357064147; 357062804; 357062109; 357060993; 357060299; 357059329; 357058634; 357057353; 357056578; 357053556; 357052720; 357051849; 357051103; 357049781; 357049065; 357048070; 357055649; 357054284; 357047050; 357045719; 357045000; 357044024; 357043219; 357042254; 357041576; 357039063; 357037951; 357037024; 357036399; 357035266; 357034687; 357033895; 357033279; 357031976; 357031440; 357030441; 357024472; 357024415; 357110220; 357109701; 357108651; 357107982; 357106937; 357106248; 357105201; 357104524; 357103487; 357102807; 357101811; 357101174; 357100182; 357099056; 357098052; 357097411; 357096439; 357095568; 357094744; 357094100; 357093083; 357092453; 357091425; 357090791; 357089806; 357089172; 357086455; 357085853; 357084856; 357084256; 357083275; 357082495; 357081800; 357081175; 357080241; 357069988; 357069505; 357068406; 357067861; 357077752; 357077180; 357076030; 357075594; 357074024; 357073349; 357072279; 357071597; 357066370; 357065602;",".","368","Blood products, collected from a donor who may have received a body piercing within 12 months of donating, were distributed.",5/16/2008,"05/16/2008",2/27/2013,"02/27/2013"
"Food",51888,"Ongoing","Hong Chang Corporation","Santa Fe Springs","CA","US","Voluntary: Firm Initiated","Letter","US.","F-1389-2013","Class II","Hokkai Medium/Large Size Oyster Meat I.Q.F., 4 lbs x 6.","No codes.",,,"The product has been prepared, packed, or held under insanitary conditions wherby it may have become contaminated with filth, or whereby it may have been rendered injurious to health.",6/25/2012,"06/25/2012",5/22/2013,"05/22/2013"
"Food",51888,"Ongoing","Hong Chang Corporation","Santa Fe Springs","CA","US","Voluntary: Firm Initiated","Letter","US.","F-1388-2013","Class II","Hokkai Tiny Oyster Meat I.Q.F., 40x8 oz","No codes.",,"unknown","The product has been prepared, packed, or held under insanitary conditions wherby it may have become contaminated with filth, or whereby it may have been rendered injurious to health.",6/25/2012,"06/25/2012",5/22/2013,"05/22/2013"
"Food",51888,"Ongoing","Hong Chang Corporation","Santa Fe Springs","CA","US","Voluntary: Firm Initiated","Letter","US.","F-1387-2013","Class II","Hokkai Frozen Half Shell Oyster, 144 pcs/case.","No codes.",,,"The product has been prepared, packed, or held under insanitary conditions wherby it may have become contaminated with filth, or whereby it may have been rendered injurious to health.",6/25/2012,"06/25/2012",5/22/2013,"05/22/2013"
"Food",51888,"Ongoing","Hong Chang Corporation","Santa Fe Springs","CA","US","Voluntary: Firm Initiated","Letter","US.","F-1390-2013","Class II","Hokkai Large Size Oyster Meat I.Q.F., 1 lb x 20, 3 lbs x 8, 1 lb x 30.","No codes.",,,"The product has been prepared, packed, or held under insanitary conditions wherby it may have become contaminated with filth, or whereby it may have been rendered injurious to health.",6/25/2012,"06/25/2012",5/22/2013,"05/22/2013"
"Food",51892,"Completed","BA Sweetie Candy Co","Brooklyn","OH","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","The product was distributed to one customer in Ohio.","F-1039-2013","Class I","B. A. Sweetie Chocolate Bridge Mix in plastic bags 2 lb, UPC 0 17598 90609 6, 5 lb, UPC 0 17598 00609 3; & Dave's Markets Chocolate Bridge Mix in plastic bags, 4 oz, UPC 017598 70609 2.","No code.",,"72 bags","Product is being recalled because it was manufactured using peanut products recalled by Peanut Corporation of America. The peanut products has the potential to be contaminated with Salmonella",2/3/2009,"02/03/2009",3/13/2013,"03/13/2013"
"Food",51892,"Completed","BA Sweetie Candy Co","Brooklyn","OH","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","The product was distributed to one customer in Ohio.","F-1040-2013","Class I","Sugar Free/ NSA Chocolate Bridge Mix in plastic bags 2 lb, UPC 0 17598 94258 2, 5 lb, UPC 017598 04258 9 ","All codes.",,,"Product is being recalled because it was manufactured using peanut products recalled by Peanut Corporation of America. The peanut products has the potential to be contaminated with Salmonella",2/3/2009,"02/03/2009",3/13/2013,"03/13/2013"
"Food",51892,"Completed","BA Sweetie Candy Co","Brooklyn","OH","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","The product was distributed to one customer in Ohio.","F-1038-2013","Class I","B. A. Sweetie Double Dip Peanuts in plastic bags 2 lb, UPC 0 17598 90687 4, 5 lb, UPC 0 17598 00687 1; & Dave's Market Chocolate Double Dip Peanuts in plastic bags, 4 oz, UPC 017598 70687 0","No code.",,"168/4 oz plastic bags","Product is being recalled because it was manufactured using peanut products recalled by Peanut Corporation of America. The peanut products has the potential to be contaminated with Salmonella",2/3/2009,"02/03/2009",3/13/2013,"03/13/2013"
"Food",51892,"Completed","BA Sweetie Candy Co","Brooklyn","OH","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","The product was distributed to one customer in Ohio.","F-1041-2013","Class I","Sweetie Sugar Free/ NSA Chocolate Peanuts in plastic bag 2 lb, UPC 0 17598 94259 9, 5 lb, UPC 0 17598 04259 6 ","No code.",,,"Product is being recalled because it was manufactured using peanut products recalled by Peanut Corporation of America. The peanut products has the potential to be contaminated with Salmonella",2/3/2009,"02/03/2009",3/13/2013,"03/13/2013"
"Food",51893,"Completed","Giannios Candy Co Inc","Struthers","OH","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","The product was distributed in the states of OH, PA, MI, NY.","F-1031-2013","Class I","Milk Chocolate Catalog # 111, Dark Chocolate Peanut Clusters Catalog # 112 & Peanut Butter Pieces Catalog # 107 individually wrapped. Date Codes 121401-130831","Peanut Butter Pieces Catalog #107, Milk Chocolate Clusters Catalog #111 & Dark Chocolate Clusters Catalog #112 Date Codes 121401-130831",,"5,090 boxes/250 pieces","This product is being recalled because it was manufactured using peanut butter recalled by Peanut Corporation of America because it has the potential to be contaminated with Salmonella",2/6/2009,"02/06/2009",3/6/2013,"03/06/2013"
"Food",51893,"Terminated","Giannios Candy Co Inc","Struthers","OH","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","The product was distributed in the states of OH, PA, MI, NY.","F-1031-2013","Class I","Milk Chocolate Catalog # 111, Dark Chocolate Peanut Clusters Catalog # 112 & Peanut Butter Pieces Catalog # 107 individually wrapped. Date Codes 121401-130831","Peanut Butter Pieces Catalog #107, Milk Chocolate Clusters Catalog #111 & Dark Chocolate Clusters Catalog #112 Date Codes 121401-130831",,"5,090 boxes/250 pieces","This product is being recalled because it was manufactured using peanut butter recalled by Peanut Corporation of America because it has the potential to be contaminated with Salmonella",2/6/2009,"02/06/2009",3/13/2013,"03/13/2013"
"Food",51894,"Terminated","Trophy Nut Co Inc","Tipp City","OH","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Distributed nationwide, including the states of: CA, IL, IN, MD, MI, MN, NC, ND, NJ, NM, NY, OH, OK, PA, SC, TN, TX, VA, VT, and VI.","F-1522-2013","Class I","Wa Wa brand 6 oz. Pistachio Gusset","Wa Wa brand 6 oz. Pistachio Gusset UPC 26191-07724 Code Date 11/15/2010 and 2/1/2010",".",,"The product is being recalled because it was manufactured using pistachios recalled by Setton Pistachios of Terra Bella, CA because it has the potential to be contaminated with Salmonella.",4/7/2009,"04/07/2009",6/19/2013,"06/19/2013"
"Food",51894,"Terminated","Trophy Nut Co Inc","Tipp City","OH","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Distributed nationwide, including the states of: CA, IL, IN, MD, MI, MN, NC, ND, NJ, NM, NY, OH, OK, PA, SC, TN, TX, VA, VT, and VI.","F-1521-2013","Class I","America's Choice 9 oz. Giant Pistachios","America's Choice 9 oz. Giant Pistachios UPC 54807-51371 Code Date 1/19/2010 thru 1/23/2010",".",,"The product is being recalled because it was manufactured using pistachios recalled by Setton Pistachios of Terra Bella, CA because it has the potential to be contaminated with Salmonella.",4/7/2009,"04/07/2009",6/19/2013,"06/19/2013"
"Food",51894,"Terminated","Trophy Nut Co Inc","Tipp City","OH","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Distributed nationwide, including the states of: CA, IL, IN, MD, MI, MN, NC, ND, NJ, NM, NY, OH, OK, PA, SC, TN, TX, VA, VT, and VI.","F-1520-2013","Class I","Trophy Nut Brand 6 oz. natural pistachios","Trophy Nut Brand 6 oz. natural pistachios UPC 74249-19167 Code Date 0269",".",,"The product is being recalled because it was manufactured using pistachios recalled by Setton Pistachios of Terra Bella, CA because it has the potential to be contaminated with Salmonella.",4/7/2009,"04/07/2009",6/19/2013,"06/19/2013"
"Food",51894,"Terminated","Trophy Nut Co Inc","Tipp City","OH","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Distributed nationwide, including the states of: CA, IL, IN, MD, MI, MN, NC, ND, NJ, NM, NY, OH, OK, PA, SC, TN, TX, VA, VT, and VI.","F-1519-2013","Class I","Trophy Nut Brand 1.5 oz. Red Pistachio Tube and Nut Barrel Brand 1.25 oz. Red Pistachio Tube.","Trophy Nut Brand 1.5 oz. Red Pistachio Tube UPC 74249-50779 Code Date 08/16/2009 thru 10/27/2009 and Nut Barrel Brand 1.25 oz. Red Pistachio Tube UPC 74249-27779 Code Date 8/16/2009 thru 10/6/2009.",".",,"The product is being recalled because it was manufactured using pistachios recalled by Setton Pistachios of Terra Bella, CA because it has the potential to be contaminated with Salmonella.",4/7/2009,"04/07/2009",6/19/2013,"06/19/2013"
"Food",51894,"Terminated","Trophy Nut Co Inc","Tipp City","OH","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Distributed nationwide, including the states of: CA, IL, IN, MD, MI, MN, NC, ND, NJ, NM, NY, OH, OK, PA, SC, TN, TX, VA, VT, and VI.","F-1518-2013","Class I","Trophy Nut Brand 1.5 oz. tube; Trophy Nut Brand 1.25 oz. tube; Nut Barrel Brand 5 oz. Fundraising bag; and Nut Barrel Brand 1.25 oz. tube.","Trophy Nut Brand 1.5 oz. tube UPC 74249-50778 Code Date 8/9/2009 thru 11/3/2009; Trophy Nut Brand 1.25 oz. tube UPC 74249-89778 Code Date 8/16/2009 thru 10/13/2009; Nut Barrel Brand 5 oz. Fundraising bag UPC 74249-44267 Code Date 0449, 0709, and 0139; Nut Barrel Brand 1.25 oz. tube UPC 74249-27778 Code Date 8/16/2009 thru 10/13/2009.",".","45,518 lbs","The product is being recalled because it was manufactured using pistachios recalled by Setton Pistachios of Terra Bella, CA because it has the potential to be contaminated with Salmonella.",4/7/2009,"04/07/2009",6/19/2013,"06/19/2013"
"Food",51895,"Completed","Gorant Candies Inc A Division of Carlton Cards Retail Inc","Youngstown","OH","US","Voluntary: Firm Initiated","E-Mail","Product was distributed to wholesalers and retailers throughout the continental US and to Canada. US states product was distributed to includes: AL, AR, AZ, CA, CT, DE, FL, GA, IA, IL, IN, KY, MA, MD, MI, MS, NC, NE, NH, NJ, NY, OH, PA, SC, TN, TX, VA, WA, and WI.","F-1044-2013","Class I","No Sugar Added Milk Chocolate Peanuts in 10 oz and 3 oz bags","765915026179, 765915043773, 765915047549, 765915047594. Date code: 09 AU 12, 09 DE 12, 11-15-08,",,"1287 pounds","The product is being recalled because it was manufactured using peanuts that were recalled by Peanut Corporation of America because of their potential to be contaminated with Salmonella.",2/3/2009,"02/03/2009",3/13/2013,"03/13/2013"
"Food",51895,"Completed","Gorant Candies Inc A Division of Carlton Cards Retail Inc","Youngstown","OH","US","Voluntary: Firm Initiated","E-Mail","Product was distributed to wholesalers and retailers throughout the continental US and to Canada. US states product was distributed to includes: AL, AR, AZ, CA, CT, DE, FL, GA, IA, IL, IN, KY, MA, MD, MI, MS, NC, NE, NH, NJ, NY, OH, PA, SC, TN, TX, VA, WA, and WI.","F-1045-2013","Class I","No Sugar Added Bridge Mix in 12 oz bags","UPC: 765915026209, 765915047624. Date code: 09 DE 01.",,"1536 pounds","The product is being recalled because it was manufactured using peanuts that were recalled by Peanut Corporation of America because of their potential to be contaminated with Salmonella.",2/3/2009,"02/03/2009",3/13/2013,"03/13/2013"
"Food",51895,"Completed","Gorant Candies Inc A Division of Carlton Cards Retail Inc","Youngstown","OH","US","Voluntary: Firm Initiated","E-Mail","Product was distributed to wholesalers and retailers throughout the continental US and to Canada. US states product was distributed to includes: AL, AR, AZ, CA, CT, DE, FL, GA, IA, IL, IN, KY, MA, MD, MI, MS, NC, NE, NH, NJ, NY, OH, PA, SC, TN, TX, VA, WA, and WI.","F-1043-2013","Class I","Milk Chocolate Peanuts in 10 oz, 3 oz, and 5 oz bags ","Sweet Sentiments: UPC-765915043367, 765915043527; Code date: 09 AL 21, Gorant: UPC-765915043282, 765915043435, 765915047457, 765915047709, 765915045125, 765915046771; Code Date: 09 MA 30, 09 AL 15, 09 MA 25, ",,"17380 pounds","The product is being recalled because it was manufactured using peanuts that were recalled by Peanut Corporation of America because of their potential to be contaminated with Salmonella.",2/3/2009,"02/03/2009",3/13/2013,"03/13/2013"
"Food",51895,"Completed","Gorant Candies Inc A Division of Carlton Cards Retail Inc","Youngstown","OH","US","Voluntary: Firm Initiated","E-Mail","Product was distributed to wholesalers and retailers throughout the continental US and to Canada. US states product was distributed to includes: AL, AR, AZ, CA, CT, DE, FL, GA, IA, IL, IN, KY, MA, MD, MI, MS, NC, NE, NH, NJ, NY, OH, PA, SC, TN, TX, VA, WA, and WI.","F-1042-2013","Class I","Chocolate bridge mix in 10 oz, 3 oz, and 3.5 oz bags ","Sweet Sentiments: UPC-765915043329, 765915043534; Code date-09 AL 19, 09 AL 21, Gorant: UPC-765915043299, 765915017832, 765915047433, 765915046788, 765915047693; Code date-08 NO 23, 09 DE 15, 09 DE 16, 07 OC 17, 09 MA 30",,"14762 pounds","The product is being recalled because it was manufactured using peanuts that were recalled by Peanut Corporation of America because of their potential to be contaminated with Salmonella.",2/3/2009,"02/03/2009",3/13/2013,"03/13/2013"
"Biologics",52144,"Terminated","Department of the Navy","Camp Lejeune","NC","US","Voluntary: Firm Initiated","Other","NJ","B-1793-13","Class III","Red Blood Cells","W020408003424, W020408003428, W020408003445, W020408003447, W020408003436, W020408003443, W020408003432, W020408003427, W020408003230, W020408003426, W020408003450, W020408003444, W020408003440, W020408003439, W020408003437, W020408003435, W020408003434, W020408003433, W020408003429, W202408003431, W020408003425",".","21 units","Blood products, which may have been exposed to unacceptable temperatures during storage, were distributed.",12/23/2008,"12/23/2008",7/17/2013,"07/17/2013"
"Biologics",52146,"Terminated","ZLB Bioplasma, Inc.","Dayton","OH","US","Voluntary: Firm Initiated","E-Mail","IL, Germany.","B-1972-13","Class II","Source Plasma","4080319226 4080318753 4080316469 4080313795 4080300331 4080297687 4080258643 4080251284 4080250193 4080249518 4080247964 4080247099 4080245763 4080245107 4080243103 4080242441 4080240908 4080240294 4080238911 4080236960 4080235535 4080234863 4080233687 4080232326 4080231293 4080229645 4080228565 4080226946 4080225852 4080225233 4080223440 4080222876 ",,"32 units","Blood products, collected from a donor whose physical was improperly documented, were distributed.",2/28/2009,"02/28/2009",8/7/2013,"08/07/2013"
"Biologics",52180,"Terminated","Hoxworth Blood Center University of Cincinnati Medical Center","Cincinnati","OH","US","Voluntary: Firm Initiated","Letter","KY and OH","B-1745-13","Class II","Platelets Leukocytes Reduced","1126574, 1055017, 0972344",,"3 units","Blood products, collected from a donor who was at risk for variant Creutzfeldt-Jakob disease (vCJD), were distributed.",1/15/2009,"01/15/2009",8/21/2013,"08/21/2013"
"Biologics",52180,"Terminated","Hoxworth Blood Center University of Cincinnati Medical Center","Cincinnati","OH","US","Voluntary: Firm Initiated","Letter","KY and OH","B-1744-13","Class II","Fresh Frozen Plasma","1126574, 0972344, 0879913",,"3 units","Blood products, collected from a donor who was at risk for variant Creutzfeldt-Jakob disease (vCJD), were distributed.",1/15/2009,"01/15/2009",8/21/2013,"08/21/2013"
"Biologics",52180,"Terminated","Hoxworth Blood Center University of Cincinnati Medical Center","Cincinnati","OH","US","Voluntary: Firm Initiated","Letter","KY and OH","B-1743-13","Class II","Red Blood Cells Leukocytes Reduced","1126574, 0879913, 1055017, 0972344",,"4 units","Blood products, collected from a donor who was at risk for variant Creutzfeldt-Jakob disease (vCJD), were distributed.",1/15/2009,"01/15/2009",8/21/2013,"08/21/2013"
"Biologics",52243,"Terminated","Talecris Plasma Resources, Inc.","Colorado Springs","CO","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","NC","B-1542-13","Class III","Source Plasma","366113033; 366113309; 366111020; 366113237; 366113323; 366113372; 366111532; 366111640; 366111454; 366111033; 366113367; 366113916; 366113408; 366113038; 366111459; 366111050; 366111350; 366113332; 366111046, 366111331, 366111465, 366111458, 366113227, 366111560, 366111361, 366111330, 366113919, 366111008, 366113395, 366111653, 366111340, 366113013, 366111364, 366113209, 366113984, 366111646, 366113311, 366111004, 366111042, 366111635, 366113895, 366113500, 366113307, 366113845, 366111052, 366111469, 366113320, 366113906. ",".","48 units","Blood products, collected from a donor whose suitability to donate was not adequately determined, were distributed.",6/30/2008,"06/30/2008",7/10/2013,"07/10/2013"
"Biologics",52245,"Terminated","BioLife Plasma Services LP","Coralville","IA","US","Voluntary: Firm Initiated","FAX","CA","B-1375-13","Class II","Source Plasma","08IIAE8374; 08IIAE7282; 08IIAE6595; 08IIAH2718; 08IIAH2425; 08IIAH1074; 08IIAH0557; 08IIAG9210; 08IIAG8336; 08IIAG7285; 08IIAG5669; 08IIAG5288; 08IIAG3787; 08IIAG3355; 08IIAG1886; 08IIAG1450; 08IIAF3267; 08IIAF2468; 08IIAE5604; 08IIAE5050; 08IIAE3681; 08IIAE2740; 08IIAE1500; 08IIAE0848; 08IIAD9640; 08IIAD8918; 08IIAD7411; 08IIAD6779; 08IIAD6080; 08IIAD5535; 08IIAD4770; 08IIAD3972; 08IIAD2489; 08IIAD1217; 08IIAD0504; 08IIAD0018; 08IIAC7994; 08IIAC7250; 08IIAC5888; 08IIAC5172; 08IIAC0381; 08IIAB9637; 08IIAB8792; 08IIAB7823; 08IIAB5804; 08IIAB5391; 08IIAB4303; 08IIAB3433; 08IIAB2935; 08IIAB2212; 07IIAA4595; 07IIAA1170; 07IIAA0797; 07IIAA0285; 06IIAC4233; 06IIAC3869",".","56 Units","Blood products, collected from a donor with a history of Hepatitis A, were distributed.",4/7/2009,"04/07/2009",6/19/2013,"06/19/2013"
"Biologics",52246,"Terminated","American Red Cross Blood Services","Omaha","NE","US","Voluntary: Firm Initiated","FAX","NE; CO; PA; NJ; AL; OK","B-1320-13","Class II","Red Blood Cells (Apheresis) Leukocytes Reduced","009FC30192; 009GP38408; 009FC30192; 009GP38408; 009FC30202; 009GP38509; 009FC30205; 009GP38509; 009FC30205; 009GP38510; 009FC30548; 009GP38513; 009FC30548; 009GP38513; 009FC30559; 009GP38514; 009FC30559; 009GP38514; 009FC30562; 009GP38529; 009FC30562; 009GP38536; 009FC30567;009GP38536; 009FC30567; 009GP38537; 009FC30585; 009GP38537; 009FC30585; 009GP38713; 009FC30608; 009GP38713; 009FC30608; 009GP38722; 009FC30611; 009GP38722; 009FC30613; 009GP38765; 009FC30614; 009GP38765; 009FC30617; 009GP38778; 009FC30617; 009GP38778; 009FC30686; 009GP38790; 009FC30686; 009GP38790; 009FC30702; 009GP38791; 009FC30702; 009GP38791; 009FC30704; 009GP38845; 009FC30704; 009GP38848; 009FC30707; 009GP38848; 009FC30707; 009GP38858; 009GP38367; 009GP38858; 009GP38367; 009KE16379; 009GP38376; 009GP38376; 009GP38384; 009GP38384; 009GP38394; 009GP38394 ",".","70 Units","Blood products, labeled 'leukocytes reduced' which did not meet the QC requirements for leukoreduced products, were distributed.",2/27/2009,"02/27/2009",6/5/2013,"06/05/2013"
"Biologics",52248,"Terminated","Talecris Plasma Resources Inc Dba International Bioresources","Research Triangle Park","NC","US","Voluntary: Firm Initiated","FAX","North Carolina","B-1757-13","Class III","Source Plasma","368113477, 368113196, 368112733, 368112468, 368111928, 368111524, 368110980, 368110672, 368110337, 368109593, 368109176, 368108774, 368108556, 368105673, 368105400, 368105048, 368104748, 368104352, 368104082, 368103299, 368102857, 368102609, 368102190, 368101662, 368101408, 368100001, 368099530, 368099017, 368098657, 368097870, 368097647, 368097193, 368096831, 368095975, 368095635, 368095159, 368095028, 368094533, 368094268, 368093898, 368093518, 368093303, 368092635, 368092317, 368091546, 368091172, 368090881, 368089542, 368089273, 368087926, 368079629, 368079115, 368078896, 368077952, 368077703, 368077147, 368076780, 368075538, 368074011, 368073101, 368100408, 368098257 ",".","62 units","Blood products, collected from a donor who was deferred for a history of Hepatitis A, were distributed.",4/29/2009,"04/29/2009",7/24/2013,"07/24/2013"
"Biologics",52254,"Terminated","New York Blood Center, Inc.","New York","NY","US","Voluntary: Firm Initiated","Letter","NY","B-0865-13","Class II","Red Blood Cells (Apheresis) Irradiated","W047008155090B; W047008155091A; W047008155089B",,"3 units","Blood products, which did not meet the acceptable product specifications, were distributed.",3/9/2009,"03/09/2009",4/3/2013,"04/03/2013"
"Biologics",52254,"Terminated","New York Blood Center, Inc.","New York","NY","US","Voluntary: Firm Initiated","Letter","NY","B-0866-13","Class II","Red Blood Cells (Apheresis)","W047008155090A; 047008155046A; W047008155046B; W047008155053A; W047008155053B; W047008155085A; W047008155085B; W047008155087A; W047008155087B; W047008155088A; W047008155089A; W047008155091B; W047008155093A; W047008155093B; W047008155094A; W047008155094B; W047008155118B; W047008155120B; W047008155121B; W047008155122B; W047008155118A; W047008155120A; W047008155121A; W047008155122A; W047008155123A; W047008155123B; W047008155124B; W047008155125B; W047008161334B; W047008161341B; W047008184441B; W047008184422B; W047008184435B; W047008184441B; W047008155124A; W047008155125A; W047008161334A; W047008161341A; W047008184441A; W047008184422A; W047008184435A; W047008184441A ",,"42 units","Blood products, which did not meet the acceptable product specifications, were distributed. ",3/9/2009,"03/09/2009",4/3/2013,"04/03/2013"
"Biologics",52256,"Terminated","American National Red Cross (The)","Portland","OR","US","Voluntary: Firm Initiated","FAX","Medical Centers nationwide","B-0628-13","Class II","Red Blood Cells","21KS82405; 21KS82409",,"2 units","Blood products, possibility sterility compromised and contaminated, were distributed.",2/12/2009,"02/12/2009",3/20/2013,"03/20/2013"
"Biologics",52256,"Terminated","American National Red Cross (The)","Portland","OR","US","Voluntary: Firm Initiated","FAX","Medical Centers nationwide","B-0629-13","Class II","Red Blood Cells Leukocytes Reduced Irradiated","21KY24238; 21LH71621.",,"2 units","Blood products, possibility sterility compromised and contaminated, were distributed.",2/12/2009,"02/12/2009",3/20/2013,"03/20/2013"
"Biologics",52256,"Terminated","American National Red Cross (The)","Portland","OR","US","Voluntary: Firm Initiated","FAX","Medical Centers nationwide","B-0627-13","Class II","Red Blood Cells Leukocytes Reduced","21KS81850; 21KS81876; 21KS81897; 21KS81923; 21KS81935; 21KS81947; 21KS82044; 21KS82070; 21KS82103; 21KS82123; 21KS82126; 21KS82133; 21KS82142; 21KS82158; 21KS82159; 21KS82162; 21KS82165; 21KS82343; 21KS82344; 21KS82485; 21KS82487; 21KY24230; 21KY24248; 21LG75833; 21LG75842; 21LG75852; 21LG75874; 21LG75890; 21LG75920; 21LG75931; 21LG75963; 21LG75981; 21LG75982; 21LK55444; 21LK55449; 21LK55473; 21LL53586; 21LL53593; 21LL53597; 21LL53612; 21LL53616; 21LL54081; 21LL54095; 21LS04243; 21LS04244.",,"45 units","Blood products, possibility sterility compromised and contaminated, were distributed.",2/12/2009,"02/12/2009",3/20/2013,"03/20/2013"
"Biologics",52256,"Terminated","American National Red Cross (The)","Portland","OR","US","Voluntary: Firm Initiated","FAX","Medical Centers nationwide","B-0630-13","Class II","Cryoprecipitated AHF","21KS81143; 21KS81153; 21KS81169; 21KS81174; 21KS81177; 21KS81182; 21KS81406; 21KS81409; 21KS81418; 21KS81426; 21KS81876; 21KS81897; 21KS81923; 21KS81935; 21KS82044; 21KS82103; 21KS82123; 21KS82126; 21KS82133; 21KS82318; 21KS82343; 21KS82344; 21KY24230; 21KY24234; 21KY24238; 21KY24248; 21LG74950; 21LG75874; 21LG75890; 21LG75963; 21LG75981; 21LG75982; 21LH70417; 21LH70423; 21LH70426; 21LH70436; 21LH70451; 21LH70454; 21LH70460; 21LH70462; 21LH70468; 21LH70478; 21LL51972; 21LL52214, 21LL52547; 21LL53593; 21LL53597.",,"47 units","Blood products, possibility sterility compromised and contaminated, were distributed.",2/12/2009,"02/12/2009",3/20/2013,"03/20/2013"
"Biologics",52256,"Terminated","American National Red Cross (The)","Portland","OR","US","Voluntary: Firm Initiated","FAX","Medical Centers nationwide","B-0631-13","Class II","Plasma Frozen","21KS82070; 21KS82165; 21KS82485; 21KS82487; 21KW70562; 21KW70564; 21KW70567; 21KW70568; 21KW70571; 21KW70579; 21KY23565; 21KY23579; 21KY23581; 21KY23590; 21KY23592; 21KY23602; 21LG75833; 21LG75852; 21LG75961; 21LH70618; 21LH70637; 21LH70642; 21LH70644; 21LL53612.",,"24 units","Blood products, possibility sterility compromised and contaminated, were distributed.",2/12/2009,"02/12/2009",3/20/2013,"03/20/2013"
"Biologics",52256,"Terminated","American National Red Cross (The)","Portland","OR","US","Voluntary: Firm Initiated","FAX","Medical Centers nationwide","B-0632-13","Class II","Plasma Frozen Cryoprecipitate Reduced","21KS81418; 21KS81426; 21KY24230; 21LG75006; 21LH70417; 21LH70426; 21LL51972; 21LL52533; 21LL52547.",,"9 units","Blood products, possibility sterility compromised and contaminated, were distributed.",2/12/2009,"02/12/2009",3/20/2013,"03/20/2013"
"Biologics",52257,"Terminated","Talecris Plasma Resources, Inc.","Research Triangle Park","NC","US","Voluntary: Firm Initiated","FAX","North Carolina.","B-1107-13","Class II","Source Plasma","367034032, 367034336, ",".","2","Blood products, collected from a donor who received a tattoo within 12 months of donating, were distributed.",3/30/2009,"03/30/2009",6/5/2013,"06/05/2013"
"Biologics",52267,"Terminated","BioLife Plasma Services L.P.","Missoula","MT","US","Voluntary: Firm Initiated","FAX","California, Austria","B-1305-13","Class II","Source Plasma","08MMTA9682, 08MMTB0851, 08MMTB1337, 08MMTB2193, 08MMTB2754, 08MMTB4201, 08MMTB4806, 08MMTB5684, 08MMTB7612, 08MMTC5407, 08MMTD4599, 08MMTD5282, 08MMTD7218, 08MMTD7759, 08MMTD8524, 08MMTD9118, 08MMTE0004, 08MMTE0530, 08MMTE1679, 08MMTE2222, 08MMTE3113, 08MMTE3639, 08MMTE4431, 08MMTE5000, 08MMTE5803, 08MMTE6341, 08MMTE8054, 08MMTE9039, 08MMTG0340, 08MMTG2052, 08MMTG2674, 08MMTG4548, 08MMTG5251, 08MMTG6972, 08MMTG9432, 08MMTH1559, 08MMTH2210, 08MMTH3307, 08MMTH4516, 08MMTH5036, 08MMTH6212, 08MMTC3877, 08MMTC6269, 08MMTC6741, 08MMTC7565, 08MMTC8055, 08MMTC8805, 08MMTC9297, 08MMTD0410, 08MMTD1409, 08MMTD1948, 08MMTE7732 ",".","52 units","Blood products, collected from a donor whose record was incomplete, were distributed.",4/13/2009,"04/13/2009",5/1/2013,"05/01/2013"
"Biologics",52268,"Terminated","Talecris Plasma Resources, Inc.","Research Triangle Park","NC","US","Voluntary: Firm Initiated","Letter","NC","B-1443-13","Class III","Source Plasma","3830008531; 3830009771; 3830009865; 3830009612; 3830010411; 3830009520; 3830010295; 3830009775; 3830010581; 3830009051; 3830009695; 3830010420; 3830008640; 3830010711; 3830010383; 3830009301; 3830009844; 3830010915; 3830008657; 3830008535; 3830008540; 3830008794; 3830008643; 3830009187; 3830009876; 3830010693; 3830009853; 3830009512; 3830010602; 3830008504; 3830009036; 3830009296; 3830010414; 3830009601; 3830009899; 3830009341; 3830008775; 3830009060; 3830009772; 3830008808; 3830009792; 3830010384; 3830010204; 3830008770; 3830009037; 3830009686; 3830010360; 3830010112; 3830010254; 3830009776; 3830008664; 3830009525; 3830010065; 3830008822; 3830009025; 3830008999; 3830010416; 3830009654; 3830010449; 3830010455; 3830009032; 3830009222; 3830009568; 3830010852; 3830008621; 3830010276; 3830009152; 3830010378; 3830010819; 3830010389; 3830010215; 3830010742; 3830010895; 3830009808; 3830010727; 3830008545; 3830008982; 3830010077; 3830009529; 3830009696; 3830010072; 3830010407; 3830010745; 3830009159; 3830009579; 3830010261; 3830008551; 3830009135; 3830009193; 3830008778; 3830010330; 830010579 ",".","92","Blood products, collected from donors whose donor suitability was not adequately determined, were distributed.",12/2/2008,"12/02/2008",6/19/2013,"06/19/2013"
"Biologics",52269,"Terminated","Talecris Plasma Resources, Inc.","Research Triangle Park","NC","US","Voluntary: Firm Initiated","FAX","NC","B-0758-13","Class III","Source Plasma","383033676;383033437;383033025;383032539;383032332;383030509;383030274;383030058;383034026;383037227;383036451;383036067; 383035886;383035593;383035197;383034952;3830334655;383034255 383029803 ,383029600 ,383029286 ,383029044 ,383028734 ,383028522 , 383028239,383027475 ,383027303 ,383026281 ,383020830 ,383020596 , 383020280 ,383020007 ,383019791 ,383019360 ,383018812 ,383023458 , 383023441",,"37 units","Blood products, which were collected from a donor with a history of high risk behaviors, were distributed.",4/2/2009,"04/02/2009",4/3/2013,"04/03/2013"
"Biologics",52271,"Terminated","Talecris Plasma Resources, Inc.","Research Triangle Park","NC","US","Voluntary: Firm Initiated","FAX","NC","B-0639-13","Class III","Source Plasma","364056760; 364056522; 364049532; 364047809; 364045459; 364048905; 364048188; 364050495; 364047136; 364050876; 364045753; 364053409; 364045610; 364049784; 364050211; 364045655; 364056254; 364056878; 364058573; 364045975; 364053779; 364056517; 364057800; 364051610; 364056989; 364055003; 364050480; 364046017; 364048953; 364053776; 364051091; 364050883; 364049994; 364048773; 364048539; 364047844; 364056210; 364055887; 364054765; 364053392; 364049555; 364051881; 364047076; 364048418; 364049620; 364051647; 364051990; 364052046; 364052580; 364053683; 364055261; 364055249; 364049024; 364050665; 364058251; 364050330; 364048414; 364051524; 364052060; 364053414; 364050014; 364056391; 364052896; 364051993; 364048555; 364046739; 364046524; 364050607; 364046519; 364046476; 364058086; 364056869; 364060504; 364056586; 364054261; 364054118; 364050272; 364050216; 364052443; 364061314; 364057861; 364056675; 364049508; 364047675; 364052120; 364053412; 364055050; 364054839; 364058172; 364057624; 364056893; 364053690; 364050590; 364046297; 364054354; 364054614; 364048620; 364054065; 364053444; 364045779; 364051926; 364050269; 364045536; 364055406; 364047807; 364049769; 364056417; 364051486; 364050166; 364050442; ;364055138; 364047495; 364046960; 364055907; 364049166; 364048230; 364045790; 364048913; 364056565; 364054592; 364049832; 364058175; 364048228; 364048243; 364046937; 364047168; 364051482; 364051865; 364052252; 364052614; 364054925; 364060158; 364048115; 364048287; 364045968; 364056609; 364053465; 364053120; 364052903; 364052608; 364051641; 364050085; 364055025; 364050933; 364050742; 364050636; 364053130; 364045979; 364045947; 364054949; 364056864; 364056530; 364051911; 364048572; 364046886; 364049194; 364050594; 364046888; 364046015; 364047589; 364054788; 364054650; 364050573; 364049213; 364050863; 364052032; 364052938; 364056781; 364057805; 364048898; 364048075; 364047124; 364055098; 364047466; 364052626; 364047135; 364058219; 364057527; 364058657; 364046489; 364047600; 364057580; 364050114; 364047107; 364059834; 364055055",".","840 units","Blood product, collected from a donor whose donor suitability was not adequately determined, was distributed.",9/16/2008,"09/16/2008",2/27/2013,"02/27/2013"
"Biologics",52276,"Terminated","Talecris Plasma Resources, Inc.","Research Triangle Park","NC","US","Voluntary: Firm Initiated","FAX","NC","B-0207-13","Class II","Source Plasma","3750018826; 3750018468; 3750018140; 3750017888; 3750017558; 3750017267; 3750016872; 3750016618; 3750016294; 3750016103; 3750015912; 3750015355; 3750015165; 3750014628; 3750014478; 3750013901; 3750019392; 3750019209; 3750013791; 3750013274; 3750012705; 3750012296; 3750011663; 3750011357; 3750010704; 3750010364; 3750009783; 3750009359;3750008672; 3750008402 ",".","30 ","Blood products, collected from a donor who was permanently deferred, were distributed.",3/5/2009,"03/05/2009",1/16/2013,"01/16/2013"
"Biologics",52279,"Terminated","Talecris Plasma Resources, Inc.","Research Triangle Park","NC","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","NC","B-0300-13","Class II","Source Plasma","3330029477, 3330027679, 3330027202, 3330025120, 3330024506, 3330024164, 3330023581, 3330023226, 3330022681, 3330022333, 3330021059, 3330020730, 3330020209, 3330019963, 3330019508, 3330019196, 3330018730, 3330018444, 3330018035, 3330017783, 3330030309, 3330018282, 3330018712, 3330019199, 3330025765, 3330026011, 3330024976, 3330024363, 3330024052, 3330023419, 3330023101, 3330022517, 3330022195, 3330021609, 3330021307, 3330020758, 3330020486, 3330019998, 3330019726, 3330019222, 3330018765, 3330018494, 3330018062, 3330017810, 3330026718, 3330026182, 3330024953, 3330023960, 3330023396, 3330022135, 3330021580, 3330021215, 3330020676, 3330020241, 3330019793, 3330018720, 3330018265, 3330018374, 3330018793, 3330019188, 3330017772, 3330018034, 3330019059, 3330019369, 3330019837, 3330020033, 3330020587, 3330020917, 3330021424, 3330021787, 3330022332, 3330022513, 3330023224, 3330024160, 3330024499, 3330025116, 3330025523, 3330026164, 3330026563, 3330028333, 3330028819, 3330029476, 3330029945, 3330030611, 3330031014, 3330027096, 3330027533, 3330028409, 3330029375, 3330026417, 3330026023, 3330025354, 3330023120, 3330022530, 3330022215, 3330021616, 3330020481, 3330020323, 3330019728, 3330019417, 3330018956, 3330018260, 3330017828, 3330027099, 3330027829, 3330029433, 3330018381, 3330021722, 3330023176, 3330018778, 3330019135, 3330022272, 3330022619, 3330023495, 3330024089, 3330025041, 3330025479, 3330028782, 3330018441, 3330018863, 3330019904, 3330020850, 3330021260, 3330023485, 3330023882, 3330027594, 3330028065, 3330028691, 3330017850, 3330021000, 3330022117, 3330022238, 3330023010, 3330023163, 3330029378, 3330017844, 3330018092, 3330019868, 3330020167, 3330023142, 3330023459, 3330027176, 3330030150, 3330017963, 3330018244, 3330018795, 3330018946, 3330018414, 3330018970, 3330019469, 3330019720, 3330020258, 3330020551, 3330021338, 3330021896, 3330022285, 3330027030, 3330027659, 3330030365, 3330030962, 3330027788, 3330029972, 3330027293, 3330029049, 3330018504, 3330018775, 3330022766, 3330029401, 3330018790, 3330018404, 33300",".","177 units","Blood products, collected from donors who did not have a complete physical examination, were distributed.",3/19/2009,"03/19/2009",2/6/2013,"02/06/2013"
"Food",52857,"Ongoing","Miravalle Food, Inc","El Monte","CA","US","Voluntary: Firm Initiated","Telephone","US States: CA, NV, OR, ID, WA, UT, and CO.","F-1252-2013","Class II","Miravalle brand ''Pan Rallado Sazonado'', 8 oz. Seasoned bread crumbs. Also packaged in 12 pack. Product labeling reads in part:''Miravalle PAN RALLADO SAZONADO SEASONED BREAD CRUMBS Net Wt. 8 Oz.***Packed and Distributed by: Miravalle El Monte, CA 91733***''.","UPC: 7 12810-00812Lot numbers: 0010 Expiration date: 08/2013 ",,"312 dz. ","In response to a FDA inspection, the firm initiated this recall due to undeclared wheat and no nutritional facts listed, for the product ''Pan Rallado Sazonado''.",3/19/2013,"03/19/2013",4/3/2013,"04/03/2013"
"Drugs",52863,"Ongoing","Aaron Industries Inc","Lynwood","CA","US","Voluntary: Firm Initiated","Letter","Nationwide in the US: MD, MI, AL, NC, CT, NY, PA, OR, WV.","D-419-2013","Class III","Rite Aid brand Maximum Strength Tussin Cough & Cold Mucus Relief CF, (dextromethorphan HBr 10 mg, guaifenesin 200 mg and phenylephrine HCl 5 mg), 4 oz. package size, Distributed by: Rite Aid, Camp Hill, PA --- UPC Code: 0 11822 57307 8. ","Lot # 82507 and 82720.",".","27,144 bottles","Presence of Precipitate; white substance confirmed as Guaifenesin, an active ingredient was observed in some bottles. If the product is shaken or warmed the white particles goes into the solution.",4/4/2013,"04/04/2013",5/29/2013,"05/29/2013"
"Biologics",52869,"Terminated","Csl Plasma","Dayton","OH","US","Voluntary: Firm Initiated","E-Mail","IL, Germany","B-2278-13","Class II","Source Plasma","4080307345, 4080304707, 4080302925, 4080302592, 4080301045, 4080300255, 4080299405, 4080298897, 4080297920, 4080297374, 4080296503, 4080294636, 4080293921, 4080292719, 4080291766, 4080290587, 4080289563, 4080288528, 4080287610, 4080286781, 4080285527, 4080284898, 4080283608, 4080282639, 4080281633, 4080280750, 4080279432, 4080278202, 4080277455, 4080276135, 4080275539, 4080274005, 4080273426, 4080272017, 4080271214, 4080269965, 4080269311, 4080267965, 4080267509, 4080265741, 4080265152, 4080263595, 4080263070, 4080261722, 4080261025, 4080259133, 4080257782, 4080257083, 4080255635, 4080254972, 4080253554, 4080252990, 4080251596, 4080250968, 4080249611, 4080248202, 4080247456, 4080246108, 4080245334, 4080244206, 4080243261, 4080242314, 4080241356, 4080240241, 4080239230, 4080238501, 4080237421, 4080236454, 4080235314, 4080234406, 4080233427, 4080230677, 4080229940, 4080228753, 4080226819, 4080225993, 4080225136, 4080224240 ",".","78 units","Blood products, collected from a donor who did not have a complete physical examination, were distributed.",3/7/2009,"03/07/2009",9/11/2013,"09/11/2013"
"Biologics",52871,"Terminated","ZLB Bioplasma, Inc.","Cleveland","OH","US","Voluntary: Firm Initiated","Other","IL.","B-2205-13","Class III","Source Plasma","4010385306, 4010380342, 4010378525, 4010377269, 4010375680, 4010372630, 4010371286, 4010369520, 4010366600, 4010366018, 4010363199, 4010362024, 4010359948, 4010358848, 4010356507, 4010355653, 4010353634, 4010352798, 4010350869, 4010350194, 4010348008, 4010347113, 4010342557, 4010340338, 4010339336, 4010337242, 4010336024, and 4010334118. ",,"28 units","Blood products, collected from a donor, whose suitability to donate were not adequately determined, were distributed.",5/1/2009,"05/01/2009",9/4/2013,"09/04/2013"
"Biologics",52874,"Terminated","CSL Plasma, Inc.","Dayton","OH","US","Voluntary: Firm Initiated","E-Mail","Illinois, Germany","B-2277-13","Class II","Source Plasma","4080230278, 4080227918, 4080221282, 4080216664, 4080215290, 4080214606, 4080213281, 4080212687, 4080207359, 4080206207, 4080202459, 4080201975, 4080199969, 4080197473, 4080196893, 4080180169, 4080170428, 4080167977, 4080167627 ",".","19 units","Blood products, collected from a donor for whom donor suitability was not adequately determined, were distributed.",5/7/2008,"05/07/2008",9/11/2013,"09/11/2013"
"Biologics",52877,"Terminated","Talecris Plasma Resources, Inc.","El Paso","TX","US","Voluntary: Firm Initiated","FAX","NC","B-1156-13","Class III","Source Plasma","3740083441; 3740082841; 3740080126; 3740079058; 3740078680; 3740077894; 3740077329; 3740076349; 3740075984; 3740074225; 3740073916; 3740072958; 3740072504; 3740071276; 3740070953; 3740069648; 3740086734; 3740086219; 3740075209; 3740069079; 3740068171",".","21 units","Blood products, collected from a donor who failed arm inspection and/or general appearance, were distributed.",5/26/2009,"05/26/2009",5/29/2013,"05/29/2013"
"Biologics",52884,"Terminated","American National Red Cross (The)","West Henrietta","NY","US","Voluntary: Firm Initiated","Telephone","MA, NY, PA, NC","B-2362-13","Class II","Red Blood Cells Leukocytes Reduced","01FC88762; 01FC88764; 01FC88766; 01FC88771; 01FC88772; 01FC88774; 01FC88776; 01FC88778; 01FC88779; 01FC88783; 01FC88785; 01FC88789; 01FC88792; 01FC88794; 01GN39856; 01GN39859; 01GN39865; 01GN39872; ",".","18 units","Blood products, which were collected in a collection system that may have a potential defect which could compromise the sterility of the closed system, were distributed. ",6/26/2009,"06/26/2009",9/18/2013,"09/18/2013"
"Biologics",52892,"Terminated","Octapharma Plasma, Inc.","Charlotte","NC","US","Voluntary: Firm Initiated","E-Mail","Austria","B-2247-13","Class III","Source Plasma","0460054624, 0460054375, 0460053765, 0460053046, 0460052681, 0460052248, 0460050883, 0460050587, 0460050160, 0460049586, 0460049195, 0460048781, 0460048529, 0460047982, 0460047459, 0460047069, 0460046603, 0460046302, 0460045817, 0460045407, 0460044919, 0460044525, 0460044162, 0460043473, 0460043099, 0460042359, 0460041692, 0460041247, 0460040232, 0460039929, 0460038722, 0460038262, 0460037878, 0460036800, 0460036262, 0460035913, 0460035198, 0460034855, 0460034484, 0460033826, 0460033566, 0460033193, 0460032009, 0460031674, 0460031243, 0460030874, 0460030294, 0460030010, 0460029419, 0460028966, 0460028569, 0460027866, 0460027348, 0460026653, 0460026242, 0460025627, 0460025140, 0460024799, 0460024343, 0460024005, 0460023658, 0460023224, 0460022865, 0460022451, 0460022161, 0460021763, 0460021229, 0460020986, 0460020604, 0460020401, 0460020029, 0460019816, 0460019201, 0460018801, 0460018337, 0460018128, 0460017835, 0460017479, 0460017179, 0460016789, 0460016454, 0460016212, 0460015933, 0460015577, 0460014957, 0460014733, 0460014319, 0460014032, 0460013752, 0460013536, 0460013227, 0460013029, 0460012708, 0460012455, 0460012125, 0460011882, 0460011605, 0460011399, 0460011066, 0460010860, 0460010491, 0460010215, 0460009837, 0460009607, 0460009151, 0460008935, 0460008547, 0460008336, 0460008015, 0460007838, 0460007385, 0460006986, 0460006733, 0460006373, 0460006126, 0460005737, 0460005614, YA181580, YP197658, YP180952, YP180872, YP180664, YP180584, YT102264, YT102246, YT102201, YT102185, YT102164, YT102147, YT102093",".","130 units","Blood products, collected from a deferred donor, were distributed.",12/8/2008,"12/08/2008",9/11/2013,"09/11/2013"
"Biologics",53056,"Terminated","Continental Services Group, Inc.","Miami","FL","US","Voluntary: Firm Initiated","E-Mail","Florida","B-1203-13","Class II","Blood and Blood Products for Reprocessing","FH058601",".","1 unit","Blood product, which was labeled as negative for hepatitis B surface antigen (HBsAg), but tested positive for HBsAg, was distributed.",2/26/2009,"02/26/2009",5/1/2013,"05/01/2013"
"Biologics",53059,"Terminated","Biomat USA, Inc.","Amarillo","TX","US","Voluntary: Firm Initiated","Letter","Spain","B-0146-13","Class II","Source Plasma","0020185088, 0020184599, 0020184373, 0020184089, 0020183872",".","5 units","Blood products, which were not quarantined subsequent to receiving information regarding high risk behavior, were distributed.",1/19/2009,"01/19/2009",1/16/2013,"01/16/2013"
"Biologics",53061,"Terminated","Blood and Plasma Research, Inc.","Beaumont","TX","US","Voluntary: Firm Initiated","Telephone","Canada","B-0913-13","Class III","Source Plasma","Q19486, Q19487, Q19488, Q19490",,"4 units","Blood products untested for HIV and HCV by NAT were distributed.",1/15/2009,"01/15/2009",5/22/2013,"05/22/2013"
"Biologics",53064,"Terminated","Bio-Medics","Provo","UT","US","Voluntary: Firm Initiated","FAX","Austria","B-0308-13","Class II","Source Plasma","8120001398, 8120001495, 8120001622, 8120001725, 8120001873, 8120001954, 8120002241, 8120002291, 8120002471, 8120002534, 8120002726, 8120002806, 8120003353, 8120003445, 8120003582, 8120003690, 8120003794, 8120003905, 8120004027, 8120004135, 8120004270, 8120004451, 8120004540, 8120004655, 8120004758, 8120004888, 8120004971",".","27 units","Blood products, collected from a donor in which donor suitability was not adequately determined, were distributed.",6/11/2008,"06/11/2008",1/2/2013,"01/02/2013"
"Biologics",53065,"Terminated","Biomat USA, Inc.","Logan","UT","US","Voluntary: Firm Initiated","FAX","Austria","B-0339-13","Class II","Source Plasma","0660055061, 0660054502, 0660054240, 0660049416, 0660048942, 0660048564, 0660047987, 0660047710, 0660047085, 0660046742, 0660046235, 0660045960, 0660045588, 0660045338, 0660044759, 0660044393, 0660043882, 0660043549, 0660041282, 0660040566, 0660040325, 0660039692, 0660039074, 0660038222, 0660037800, 0660037736, 0660037193, 0660036536, 0660036319, 0660035739, 0660035564, 0660035055, 0660034745, 0660034036, 0660033826, 0660033293, 0660032698, 0660032218, 0660031927, 0660031452, 0660031150",".","41 units","Blood products, collected from a donor with a history of incarceration, were distributed.",7/14/2009,"07/14/2009",2/6/2013,"02/06/2013"
"Biologics",53175,"Terminated","Continental Services Group, Inc.","Miami","FL","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Switzerland","B-1202-13","Class II","Blood and Blood Products for Reprocessing","LQ107428",".","1 unit","Blood product, which tested positive for the human immunodeficiency virus (HIV), but was labeled as negative for HIV, was distributed.",7/28/2009,"07/28/2009",5/1/2013,"05/01/2013"
"Biologics",53200,"Terminated","American National Red Cross (The)","Little Rock","AR","US","Voluntary: Firm Initiated","FAX","AR, TN, TX, CA, MD, MO, OK","B-1377-13","Class II","Red Blood Cells Leukocytes Reduced","55C55567, 55C55574, 55C55579, 55C55582, 55C55585, 55C55605, 55C55615, 55F27724, 55F27727, 55F27731, 55F27734, 55FR76508, 55FR76879, 55FR76883, 55FR76886, 55FR76889, 55FR76891, 55FV27304, 55FV27307, 55FV27310, 55FV27312, 55FV27314, 55FV27316, 55FV27401, 55FV27452, 55FV27454, 55FV27457, 55FV27459, 55FV27475, 55FV27477, 55FZ22426, 55FZ22429, 55FZ22431, 55FZ22433, 55FZ22434, 55FZ22437, 55FZ22626, 55FZ22636, 55R81325, 55R81338, 55R81370, 55R81373, 55R81378, 55R81380, 55R81383, 55R81385, 55R81395, 55R81488, 55R81493, 55R81496, 55R81503, 55R81506, 55R81507, 55R81510, 55R81511, 55R81514, 55R81517, 55R81522, 55R81620, 55R81622, 55R81625, 55S72663, 55S72664, 55S72666, 55S72671, 55S72681, 55S72687, 55S72695, 55S72702, 55S72718, 55S72722, 55S72734, 55S72796, 55S72799, 55S72804, 55S72806, 55S72809, 55S72814, 55S72816, 55W81343, 55W81349, 55W81350, 55W81355, 55W81356, 55FV27450",,"85 units","Blood products, collected in a manner that may have compromised the sterility of the units, were distributed.",7/17/2009,"07/17/2009",6/26/2013,"06/26/2013"
"Biologics",53200,"Terminated","American National Red Cross (The)","Little Rock","AR","US","Voluntary: Firm Initiated","FAX","AR, TN, TX, CA, MD, MO, OK","B-1378-13","Class II","Plasma Frozen within 24 hours (FP24)","55C55570, 55C55582, 55C55615, 55C55618, 55F27724, 55FR76508, 55FR76883, 55FR76891, 55FV27304, 55FV27316, 55FV27401, 55FV27477, 55FZ22433, 55FZ22434, 55FZ22437, 55FZ22626, 55FZ22641, 55R81383, 55R81385, 55R81395, 55R81398, 55R81503, 55R81507, 55R81511, 55R81522, 55S72664, 55S72671, 55S72687, 55S72718, 55S72814, 55W81355, 55FZ22634",,"32 units","Blood products, collected in a manner that may have compromised the sterility of the units, were distributed.",7/17/2009,"07/17/2009",6/26/2013,"06/26/2013"
"Biologics",53200,"Terminated","American National Red Cross (The)","Little Rock","AR","US","Voluntary: Firm Initiated","FAX","AR, TN, TX, CA, MD, MO, OK","B-1379-13","Class II","Whole Blood","55C55601",,"1 unit","Blood products, collected in a manner that may have compromised the sterility of the units, were distributed.",7/17/2009,"07/17/2009",6/26/2013,"06/26/2013"
"Biologics",53201,"Terminated","Talecris Plasma Resources, Inc.","Research Triangle Park","NC","US","Voluntary: Firm Initiated","Letter","NC","B-0780-13","Class II","Source Plasma","375045485; 375048882; 375049084; 375049221; 375055501; 375055797; 375056342; 375057428; 375057950; 375049063; 375053713; 375057572; 375049008; 375049023; 375050131; 375050997; 375051299; 375051912; 375052053; 375052633; 375052819; 375049119; 375049164; 375050974; 375051238; 375051638; 375051869; 375053244; 375049122; 375049150; 375043877; 375044054; 375044502; 375044681; 375050865; 375051086; 375051569; 375052169; 375052257; 375052818; 375052961; 375054020; 375054135; 375054609; 375054769; 375055355; 375055404; 375055951; 375056080; 375056776; 375057001; 375057405; 375040851; 375040813; 375049127; 375049158; 375052604; 375059107; 375035760; 375035899; 375036335; 375036553; 375037320; 375037507; 375039637; 375039900; 375040417; 375041246; 375041601; 375042557; 375051074; 375051650; 375052008; 375052340; 375052700; 375053091; 375057467; 375057728; 375058334; 375059064; 375059611; 375059941; 375061471; 3750000723; 3750002056; 3750003323; 375031933; 375031965; 375037842; 375038068; 375047491; 375050828; 375055626; 375055845; 375060823; 375061146; 375045293; 375049144; 375050588; 375052712; 375053363; 375054021; 375054478; 375054821; 375055318; 375055648; 375056084; 375056428; 375049054; 375050448; 375050659; 375051079; 375051317; 375052274; 375052496; 375054416; 375054683; 375055248; 375055555; 375057420; 375031648; 375031726; 375033811; 375034200; 375034581; 375034854; 375035201; 375035962; 375040880; 375040890; 375044436; 375045615; 375047839; 375045252; 375045315; 375031901; 375031964; 375031665; 375031694; 375033817; 375049082; 375049212; 375051184; 375052975; 375054548; 375054920; 375040857; 375040904; 375040635; 375040685; 375042335; 375042703; 375043013; 375043991; 375044242; 375031689; 375031737; 375034179; 375034371; 375040628; 375040658; 375047585; 375047772; 375049109; 375049162; 375051243; 375051360; 375052210; 375052425; 375052991; 375053181; 375054320; 375054794; 375055088; 375055427; 375055710; 375057030; 375057181; 375057656; 375058006; 375058373; 375040670; 375040716; 375042570; 375049004; 3750491",".","931 units","Blood products, collected from donors who did not have a complete physical examination, were distributed.",8/12/2009,"08/12/2009",3/27/2013,"03/27/2013"
"Biologics",53334,"Terminated","American National Red Cross (The)","Little Rock","AR","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","AR","B-0338-13","Class III","Red Blood Cells Leukocytes Reduced Washed","55R77401",".","1 unit","Blood product, for which the red cell count and hematocrit were outside the acceptable range, was distributed.",3/5/2009,"03/05/2009",2/27/2013,"02/27/2013"
"Biologics",53422,"Terminated","Biomat USA, Inc.","Everett","WA","US","Voluntary: Firm Initiated","FAX","Spain, California.","B-0759-13","Class II","Source Plasma","0130049526, 0130050511.",,"2 units","Blood products, collected from a donor who had been incarcerated, were distributed.",12/3/2008,"12/03/2008",4/3/2013,"04/03/2013"
"Devices",53487,"Terminated","Spinal Elements, Inc","Carlsbad","CA","US","Voluntary: Firm Initiated","Letter","Distributed in OH and PA.","Z-1259-2013","Class III","Mercury Spinal System DIA 5.5 x 60mm Straight Rod, Part Number: 60101-060. Intended to provide immobilization and stabilization of the spine in skeletally mature patients. ","Lot Number: 080594",".","68 units total ","Spinal Elements has initiated a recall for the Mercury Spinal System due to a raw material issue.",4/17/2009,"04/17/2009",5/15/2013,"05/15/2013"
"Devices",53487,"Terminated","Spinal Elements, Inc","Carlsbad","CA","US","Voluntary: Firm Initiated","Letter","Distributed in OH and PA.","Z-1261-2013","Class III","Mercury Spinal System DIA 5.5 x 80mm Straight Rod, Part Number: 60101-080. Intended to provide immobilization and stabilization of the spine in skeletally mature patients. ","Lot Number: 080597",".","68 units total ","Spinal Elements has initiated a recall for the Mercury Spinal System due to a raw material issue.",4/17/2009,"04/17/2009",5/15/2013,"05/15/2013"
"Devices",53487,"Terminated","Spinal Elements, Inc","Carlsbad","CA","US","Voluntary: Firm Initiated","Letter","Distributed in OH and PA.","Z-1257-2013","Class III","Mercury Spinal System DIA 5.5 x 40mm Straight Rod, Part Number: 60101-040. Intended to provide immobilization and stabilization of the spine in skeletally mature patients. ","Lot Number: 080593",".","68 units total","Spinal Elements has initiated a recall for the Mercury Spinal System due to a raw material issue.",4/17/2009,"04/17/2009",5/15/2013,"05/15/2013"
"Devices",53487,"Terminated","Spinal Elements, Inc","Carlsbad","CA","US","Voluntary: Firm Initiated","Letter","Distributed in OH and PA.","Z-1253-2013","Class III","Mercury Spinal System DIA 5.5 x 100mm Lordosed Rod, Part Number: 60100-100. Intended to provide immobilization and stabilization of the spine in skeletally mature patients. ","Lot Number: 080589",".","68 units total","Spinal Elements has initiated a recall for the Mercury Spinal System due to a raw material issue.",4/17/2009,"04/17/2009",5/15/2013,"05/15/2013"
"Devices",53487,"Terminated","Spinal Elements, Inc","Carlsbad","CA","US","Voluntary: Firm Initiated","Letter","Distributed in OH and PA.","Z-1262-2013","Class III","Mercury Spinal System DIA 5.5 x 90mm Straight Rod, Part Number: 60101-090. Intended to provide immobilization and stabilization of the spine in skeletally mature patients. ","Lot Number: 080598",".","68 units total ","Spinal Elements has initiated a recall for the Mercury Spinal System due to a raw material issue.",4/17/2009,"04/17/2009",5/15/2013,"05/15/2013"
"Devices",53487,"Terminated","Spinal Elements, Inc","Carlsbad","CA","US","Voluntary: Firm Initiated","Letter","Distributed in OH and PA.","Z-1263-2013","Class III","Mercury Spinal System DIA 5.5 x 100mm Straight Rod, Part Number: 60101-100. Intended to provide immobilization and stabilization of the spine in skeletally mature patients. ","Lot Number: 080599",".","68 units total ","Spinal Elements has initiated a recall for the Mercury Spinal System due to a raw material issue.",4/17/2009,"04/17/2009",5/15/2013,"05/15/2013"
"Devices",53487,"Terminated","Spinal Elements, Inc","Carlsbad","CA","US","Voluntary: Firm Initiated","Letter","Distributed in OH and PA.","Z-1249-2013","Class III","Mercury Spinal System DIA 5.5 x 60 MM Lordosed Rod, Part Number: 60100-060. Intended to provide immobilization and stabilization of the spine in skeletally mature patients. ","Lot Number: 080585",".","68 units total","Spinal Elements has initiated a recall for the Mercury Spinal System due to a raw material issue.",4/17/2009,"04/17/2009",5/15/2013,"05/15/2013"
"Devices",53487,"Terminated","Spinal Elements, Inc","Carlsbad","CA","US","Voluntary: Firm Initiated","Letter","Distributed in OH and PA.","Z-1252-2013","Class III","Mercury Spinal System DIA 5.5 x 90 MM Lordosed Rod, Part Number: 60100-090. Intended to provide immobilization and stabilization of the spine in skeletally mature patients. ","Lot Number: 080588",".","68 units total","Spinal Elements has initiated a recall for the Mercury Spinal System due to a raw material issue.",4/17/2009,"04/17/2009",5/15/2013,"05/15/2013"
"Devices",53487,"Terminated","Spinal Elements, Inc","Carlsbad","CA","US","Voluntary: Firm Initiated","Letter","Distributed in OH and PA.","Z-1264-2013","Class III","Mercury Spinal System DIA 5.5 x 110mm Straight Rod, Part Number: 60101-110. Intended to provide immobilization and stabilization of the spine in skeletally mature patients. ","Lot Number: 080600",".","68 units total ","Spinal Elements has initiated a recall for the Mercury Spinal System due to a raw material issue.",4/17/2009,"04/17/2009",5/15/2013,"05/15/2013"
"Devices",53487,"Terminated","Spinal Elements, Inc","Carlsbad","CA","US","Voluntary: Firm Initiated","Letter","Distributed in OH and PA.","Z-1251-2013","Class III","Mercury Spinal System DIA 5.5 x 80 MM Lordosed Rod, Part Number: 60100-080. Intended to provide immobilization and stabilization of the spine in skeletally mature patients. ","Lot number: 080587",".","68 units total","Spinal Elements has initiated a recall for the Mercury Spinal System due to a raw material issue.",4/17/2009,"04/17/2009",5/15/2013,"05/15/2013"
"Devices",53487,"Terminated","Spinal Elements, Inc","Carlsbad","CA","US","Voluntary: Firm Initiated","Letter","Distributed in OH and PA.","Z-1255-2013","Class III","Mercury Spinal System DIA 5.5 x 120mm Lordosed Rod, Part Number: 60100-120. Intended to provide immobilization and stabilization of the spine in skeletally mature patients. ","Lot Number: 080591",".","68 units total","Spinal Elements has initiated a recall for the Mercury Spinal System due to a raw material issue.",4/17/2009,"04/17/2009",5/15/2013,"05/15/2013"
"Devices",53487,"Terminated","Spinal Elements, Inc","Carlsbad","CA","US","Voluntary: Firm Initiated","Letter","Distributed in OH and PA.","Z-1258-2013","Class III","Mercury Spinal System DIA 5.5 x 50mm Straight Rod, Part Number: 60101-050. Intended to provide immobilization and stabilization of the spine in skeletally mature patients. ","Lot Number: 080594",".","68 units total","Spinal Elements has initiated a recall for the Mercury Spinal System due to a raw material issue.",4/17/2009,"04/17/2009",5/15/2013,"05/15/2013"
"Devices",53487,"Terminated","Spinal Elements, Inc","Carlsbad","CA","US","Voluntary: Firm Initiated","Letter","Distributed in OH and PA.","Z-1248-2013","Class III","Mercury Spinal System DIA 5.5 x 50 MM Lordosed Rod, Part Number: 60100-050. Intended to provide immobilization and stabilization of the spine in skeletally mature patients. ","Lot Number: 080584",".","68 units total","Spinal Elements has initiated a recall for the Mercury Spinal System due to a raw material issue.",4/17/2009,"04/17/2009",5/15/2013,"05/15/2013"
"Devices",53487,"Terminated","Spinal Elements, Inc","Carlsbad","CA","US","Voluntary: Firm Initiated","Letter","Distributed in OH and PA.","Z-1260-2013","Class III","Mercury Spinal System DIA 5.5 x 70mm Straight Rod, Part Number: 60101-070. Intended to provide immobilization and stabilization of the spine in skeletally mature patients. ","Lot Number: 080596",".","68 units total ","Spinal Elements has initiated a recall for the Mercury Spinal System due to a raw material issue.",4/17/2009,"04/17/2009",5/15/2013,"05/15/2013"
"Devices",53487,"Terminated","Spinal Elements, Inc","Carlsbad","CA","US","Voluntary: Firm Initiated","Letter","Distributed in OH and PA.","Z-1246-2013","Class III","Mercury Spinal System DIA 5.5 x 30 MM Lordosed Rod, Part Number: 60100-030. Intended to provide immobilization and stabilization of the spine in skeletally mature patients. ","Lot Number: 080582",".","68 units total","Spinal Elements has initiated a recall for the Mercury Spinal System due to a raw material issue.",4/17/2009,"04/17/2009",5/15/2013,"05/15/2013"
"Devices",53487,"Terminated","Spinal Elements, Inc","Carlsbad","CA","US","Voluntary: Firm Initiated","Letter","Distributed in OH and PA.","Z-1256-2013","Class III","Mercury Spinal System DIA 5.5 x 30mm Straight Rod, Part Number: 60101-030. Intended to provide immobilization and stabilization of the spine in skeletally mature patients. ","Lot number: 080592",".","68 units total","Spinal Elements has initiated a recall for the Mercury Spinal System due to a raw material issue.",4/17/2009,"04/17/2009",5/15/2013,"05/15/2013"
"Devices",53487,"Terminated","Spinal Elements, Inc","Carlsbad","CA","US","Voluntary: Firm Initiated","Letter","Distributed in OH and PA.","Z-1266-2013","Class III","Mercury Spinal System DIA 5.5 x 400mm Straight Rod, Part Number: 60101-400. Intended to provide immobilization and stabilization of the spine in skeletally mature patients. ","Lot Number: 080602",".","68 units total","Spinal Elements has initiated a recall for the Mercury Spinal System due to a raw material issue.",4/17/2009,"04/17/2009",5/15/2013,"05/15/2013"
"Devices",53487,"Terminated","Spinal Elements, Inc","Carlsbad","CA","US","Voluntary: Firm Initiated","Letter","Distributed in OH and PA.","Z-1265-2013","Class III","Mercury Spinal System DIA 5.5 x 120mm Straight Rod, Part Number: 60101-120. Intended to provide immobilization and stabilization of the spine in skeletally mature patients. ","Lot Number: 080601",".","68 units total ","Spinal Elements has initiated a recall for the Mercury Spinal System due to a raw material issue.",4/17/2009,"04/17/2009",5/15/2013,"05/15/2013"
"Devices",53487,"Terminated","Spinal Elements, Inc","Carlsbad","CA","US","Voluntary: Firm Initiated","Letter","Distributed in OH and PA.","Z-1254-2013","Class III","Mercury Spinal System DIA 5.5 x 110mm Lordosed Rod, Part Number: 60100-110. Intended to provide immobilization and stabilization of the spine in skeletally mature patients. ","Lot number: 080590",".","68 units total","Spinal Elements has initiated a recall for the Mercury Spinal System due to a raw material issue.",4/17/2009,"04/17/2009",5/15/2013,"05/15/2013"
"Devices",53487,"Terminated","Spinal Elements, Inc","Carlsbad","CA","US","Voluntary: Firm Initiated","Letter","Distributed in OH and PA.","Z-1247-2013","Class III","Mercury Spinal System DIA 5.5 x 40 MM Lordosed Rod, Part Number: 60100-040. Intended to provide immobilization and stabilization of the spine in skeletally mature patients. ","Lot Number: 080583",".","68 units total","Spinal Elements has initiated a recall for the Mercury Spinal System due to a raw material issue.",4/17/2009,"04/17/2009",5/15/2013,"05/15/2013"
"Devices",53487,"Terminated","Spinal Elements, Inc","Carlsbad","CA","US","Voluntary: Firm Initiated","Letter","Distributed in OH and PA.","Z-1250-2013","Class III","Mercury Spinal System DIA 5.5 x 70 MM Lordosed Rod, Part Number: 60100-070. Intended to provide immobilization and stabilization of the spine in skeletally mature patients. ","Lot number: 080586",".","68 units total","Spinal Elements has initiated a recall for the Mercury Spinal System due to a raw material issue.",4/17/2009,"04/17/2009",5/15/2013,"05/15/2013"
"Drugs",53558,"Ongoing","Kareway Product Inc","Compton","CA","US","Voluntary: Firm Initiated","Letter","Nationwide in the US: CA, OR, WA. Africa.","D-620-2013","Class II","Pure-Aid Allergy Relief, Diphenhydramine HCL Caplets, 25 mg, 20 caplets, Exclusively distributed by: Kareway Products Inc., Compton, CA --- UPC 8 56023 00158 2","Lot# 6781202 & 6781302",,"24,048 cartons","Labeling: Not Elsewhere Classified; foil label on immediate blister pack indicates active ingredient as Chlorpheniramine rather than Diphenhydramine ",5/3/2013,"05/03/2013",7/3/2013,"07/03/2013"
"Biologics",53621,"Terminated","Community Blood Center Of Gtr KC","Kansas City","MO","US","Voluntary: Firm Initiated","FAX","MO; KS; LA; CA;","B-1825-13","Class II","Plasma Frozen Within 24 Hours After Phlebotomy (FP24)","W045008120117; W045008117439; W045008117425; W045008119923; W045008119929; W045008111075; W045008120118; W045008117428; W045008913211; W045008115790; W045008111068; W045008110803; W045008095756; W045008111946; W045008108338; W045008108721; W045008119951; W045008119995; W045008119926; W045008108796; W045008120116; W045008129855; W045008129852; W045008120025; W045008119991; W045008119893; W045008117463; W045008115778; W045008115702; W045008115633; W045008111976",".","31 Units","Blood products, collected in a manner that may have compromised the sterility of the units, were distributed. ",2/3/2009,"02/03/2009",7/24/2013,"07/24/2013"
"Biologics",53621,"Terminated","Community Blood Center Of Gtr KC","Kansas City","MO","US","Voluntary: Firm Initiated","FAX","MO; KS; LA; CA;","B-1824-13","Class II","Red Blood Cells Leukocytes Reduced","W045008125859; W045008120117; W045008117463; W045008111946; W045008110989; W045008125925; W045008108260; W045008120091; W045008108305; W045008125939; W045008120163; W045008117428; W045008111068; W045008105566; W045008125812; W045008120184; W045008115702; W045008120115; W045008129826; W045008125919; W045008125203; W045008115685; W045008119980; W045008913232; W045008129832; W045008125399; W045008108310; W045008125660; W045008125922; W045008119876; W045008115637; W045008108306; W045008108304; W045008108294; W045008097193; W045008125923; W045008119838; W045008117459; W045008111075; W045008108333; W045008108327; W045008108321; W045008115778; W045008110803; W045008108721; W045008125941; W045008125678; W045008120106; W045008120097;W045008125943; W045008125813; W045008120092; W045008119995; W045008117417; W045008117413; W045008125914; W045008108757; W045008913235; W045008125398; W045008111070; W045008120149; W045008105792; W045008129848; W045008117435; W045008115676; W045008108342; W045008108340; W045008120152; W045008115633; W045008913221; W045008125670; W045008125658; W045008120158; W045008119951; W045008108856; W045008108323; W045008108796; W045008125201; W045008119991; W045008110901; W045008108399; W045008119985; W045008120025; W045008119926; W045008111951; W045008108522; W045008108510; W045008117461; W045008119329; W045008110986; W045008120028; W045008120027; W045008119923; W045008117445; W045008117439; W045008108566; W045008108544; W045008108314; W045008095756; W045008129924; W045008111978; W045008913211; W045008129861; W045008129855; W045008129852; W045008125918; W045008125816; W045008125295; W045008119893; W045008117444; W045008117425; W045008110991; W045008110940; W045008110894; W045008108998; W045008108747; W045008108724; W045008108723; W045008108299; W045008125913; W045008125911; W045008125909",".","122 Units","Blood products, collected in a manner that may have compromised the sterility of the units, were distributed. ",2/3/2009,"02/03/2009",7/24/2013,"07/24/2013"
"Biologics",53628,"Terminated","Talecris Plasma Resources, Inc.","Research Triangle Park","NC","US","Voluntary: Firm Initiated","FAX","NC","B-1204-13","Class III","Source Plasma","3740050804; 3740051489; ",,"2 units","Blood products, collected from a donor whose donor suitability was not adequately determined, were distributed.",9/16/2009,"09/16/2009",5/8/2013,"05/08/2013"
"Biologics",53631,"Terminated","CSL Plasma, Inc.","Tucson","AZ","US","Voluntary: Firm Initiated","Other","IL","B-2030-13","Class II","Source Plasma","6240281727, 6240279727, 6240279034, 6240276220, 6240274982, 6240269240, 6240268017, 6240265756, 6240263938, 6240261729, 6240260270, 6240258649, 6240257869, 6240255932, 6240255078, 6240253287, 6240252535, 6240250203, 6240249354, 6240247835, 6240246792, 6240245034, 6240244209, 6240242549, 6240241771, 6240240130, 6240239304",".","27 units","Blood products, collected from a donor who did not have a complete physical examination, were distributed.",8/18/2009,"08/18/2009",8/14/2013,"08/14/2013"
"Biologics",53640,"Terminated","BioLife Plasma Services LP","Joplin","MO","US","Voluntary: Firm Initiated","FAX","CA","B-1624-13","Class II","Source Plasma","09JMOC7038;09JMOC6415;09JMOC4184;09JMOC3299;09JMOB7889;09JMOB7058;09JMOB5778;09JMOB4515;09JMOB2187;09JMOA7431;09JMOA6680;09JMOA4269;09JMOA2844;09JMOA0654;08JMOK5375;08JMOK5119;08JMOK3680;09JMOC9312;08JMOK1687;08JMOK1133;08JMOJ9615;08JMOJ8551;08JMOJ5074;08JMOJ4145;08JMOJ2690;08JMOJ1794;08JMOJ0294;08JMOI9447;08JMOI8093;08JMOI7418;08JMOI5784;08JMOI4798;08JMOI3458;08JMOI2427;08JMOI1121;08JMOI0396;08JMOH8755;08JMOH7876;08JMOH6484;08JMOH5568",,"40 Units","Blood products, which were collected from a donor who had received a ear piercing within 12 months of the donation, were distributed.",8/19/2009,"08/19/2009",7/3/2013,"07/03/2013"
"Devices",53991,"Terminated","CareFusion Corporation","San Diego","CA","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution - USA (Nationwide) including CANADA.","Z-1015-2013","Class II","Pyxis Anesthesia System Model 2000 (PAS 2000) Product Usage: The PAS 2000 is an anesthesia medication dispensing device that provides medications and inventory management for the anesthesiologist at the point of care within the operating room. ","All Pyxis Anesthesia System Model 2000 ",,"2637","The recall was initiated because Carefusion has confirmed that when the PAS 2000 drawers due to inaccessability of drawers caused by system down time or lock-up.",11/20/2009,"11/20/2009",4/3/2013,"04/03/2013"
"Biologics",54045,"Terminated","Community Blood Center Of Gtr KC","Kansas City","MO","US","Voluntary: Firm Initiated","Telephone","MO, IN, KS, CA,","B-1121-13","Class II","Platelets Pheresis Leukocytes Reduced","W045006901629 Part 1;W045006901629 Part 2",,"2 units","Blood products, collected from a donor who was in close contact with an individual diagnosed with viral hepatitis, were distributed.",9/5/2009,"09/05/2009",5/22/2013,"05/22/2013"
"Biologics",54045,"Terminated","Community Blood Center Of Gtr KC","Kansas City","MO","US","Voluntary: Firm Initiated","Telephone","MO, IN, KS, CA,","B-1120-13","Class II","Fresh Frozen Plasma","W045008039358; W045008115056; W045009058101",,"3 units","Blood products, collected from a donor who was in close contact with an individual diagnosed with viral hepatitis, were distributed.",9/5/2009,"09/05/2009",5/22/2013,"05/22/2013"
"Biologics",54045,"Terminated","Community Blood Center Of Gtr KC","Kansas City","MO","US","Voluntary: Firm Initiated","Telephone","MO, IN, KS, CA,","B-1119-13","Class II","Red Blood Cells Leukocytes Reduced"," W045008039358; W045008115056; W045009058101",,"3","Blood products, collected from a donor who was in close contact with an individual diagnosed with viral hepatitis, were distributed.",9/5/2009,"09/05/2009",5/22/2013,"05/22/2013"
"Biologics",54054,"Terminated","CSL Plasma, Inc.","Tempe","AZ","US","Voluntary: Firm Initiated","Other","Illinois. Switzerland and Germany.","B-2177-13","Class II","Source Plasma","0481274943, 0481267845, 0481260767, 0481259656, 0481257087, 0481256095, 0481253621, 0481252570, 0481249963, 0481246361, 0481245224, 0481240119, 0481239505, 0481235759, 0481234613, 0481228709, 0481227587, 0481225159, 0481224060, 0481220020, 0481215883, 0481211480, 0481210598, 0481200573, 0481198622, 0481197773, 0481193693, 0481191387, 0481189545, 0481187521, 0481184717, 0481183479, 0481172823, 0481164378, 0481161825, 0481159788, 0481158377, 0481156112, 0481155099, 0481152754, 0481151615, 0481147022, 0481144721, 0481141576, 0481139054 ",,"45","Blood products, collected from a donor whose scheduled physical examination was incomplete, were distributed.",10/12/2009,"10/12/2009",9/25/2013,"09/25/2013"
"Biologics",54058,"Terminated","Talecris Plasma Resources Inc","Research Triangle Park","NC","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","North Carolina","B-0716-13","Class III","Source Plasma","380098221, 380091801, 380095082, 380102319, 380093481, 380113918, 380106427, 380096985, 3800003417, 380100217, 380100491, 380111162, 380106940, 380107283, 380108885, 380111205, 380104488, 380105322, 380103028, 380098015, 380106785, 380099826, 380095696, 380092908, 380091944, 380108728, 380092169, 3800049989, 380111054, 380106540, 380104691, 380105648, 380097869, 3800024783, 380113213, 380114842, 380112449, 380104240, 380097106, 380107764, 380108063, 380111541, 38011917, 380100306, 3800007683, 380100117,380120861, 380114378, 380113395, 380112672, 380107722, 3800007855, 3800011972, 3800013705, 3800016966, 380112192, 380112456, 380113203, 380114527, 380107768, 380109650, 380109901, 380111431, 380106685, 3800014815, 3800011631, 3800011977, 3800016720, 3800018904, 3800023822, 3800025939, 3800032229, 380100438, 380113307, 3800012543, 380102704, 380102364, 380096979, 380093172, 380093149, 3800050812, 3800021421, 3800025602, 3800026282, 3800027849, 3800029571, 380120851, 380105380, 380100148, 380113303, 380120373, 380121848, 380109112, 3800005308, 3800007956, 3800009234, 3800011442, 3800013842, 3800014431, 3800014842, 3800009674, 3800010055, 3800012243, 3800015013, 3800015974, 3800019953, 3800031201, 3800031690, 3800032689, 3800034010, 3800027339, 3800038761, 3800049593, 3800050008, 3800046124, 3800046292, 3800026797, 380098580, 380093088, 380104542, 3800018583, 3800025291, 3800021451, 380103487, 380100121, 3800047949, 380112649, 380113562, 380114067, 380108072, 380109870, 380111125, 380105366, 380097323, 380097691, 380095356, 380114389, 380113356, 380112650, 380108073, 380106724, 380098847, 380095756, 380108332, 3800048043, 3800050794, 3800051176, 380096594, 380096304, 380094618, 380099701, 380100610, 380101245, 380095750, 380096876, 380092447, 380093902, 380108464, 380104116, 380093042, 380099135, 380111015, 380105336, 380094367, 380102766, 380106535, 380108169, 380108474, 380119567, 380120390, 380121675, 380122367, 380122968, 3800003310, 3800004240, 3800005911, 3800013330, 3800013741, 3800014428, 3800022854, 380002"," 380108395, 380108903, 380106269, 380105297, 380101525, 380096989, 380097321, 380092523, 380092884, 380113133, 380111313, 380106440, 380104781, 380097864, 380092568, 380107381, 380107814, 3800000066, 3800000454, 3800002840, 3800003206, 3800003660, 3800004317, 3800005070, 3800005960, 3800007159, 3800018276, 3800020532, 3800021015, 3800022735, 3800025209, 3800028219, 3800031151, 3800031502, 3800032514, 3800033182, 3800033515, 3800033840, 3800034668, 3800042334, 3800045308, 3800047622, 3800049617, 3800050181, 3800052480, 3800053346, 3800049778, 3800050064, 3800051114, 3800053452, 380112174, 380111933, 380106271, 380095358, 380091950, 3800009153, 3800013468, 3800014492, 3800015178, 3800018265, 3800021061, 3800021669, 3800023960, 3800025035, 3800027377, 3800028600, 3800032206, 3800034876, 3800046897, 3800048949, 3800051826, 380106838, 380087428, 380097349, 3800000503, 3800002623, 3800003214, 3800005843, 3800012465, 3800013444, 3800015176, 3800015495, 3800018111, 3800018418, 3800021388, 3800027772, 3800022486, 3800026841, 3800027949, 3800031456, 3800032498, 3800033133, 3800033788, 3800036635, 3800037162, 3800046227, 3800017956, 3800020789, 3800021420, 3800027251, 3800028570, 3800030244, 3800030837, 3800033544, 3800031729, 3800037009, 3800050805, 3800052239, 3800014412, 3800030269, 3800032905, 3800034967, 3800038091, 3800046128, 380113512, 380112273, 380107731, 380104428, 380098415, 380096116, 380091993, 3800001167, 3800003059, 3800004462, 3800005795, 3800010085, 3800011891, 3800013770, 3800015133, 3800018436, 3800038231, 380122891, 380120636, 380106770, 380103510, 380097148, 3800004635, 380106668, 380092438, 380100601, 3800015920, 3800026162, 3800046392, 380111232, 380102740, 3800000775, 3800004216, 3800004440, 3800006441, 3800007465, 3800007765, 380119508, 380113805, 380111952, 380108478, 380107084, 380122086, 380114282, 380121311, 380111304, 380111979, 380102720, 380105443, 3800000497, 3800003708, 3800004453, 3800007216, 3800015063, 380122831, 380102076, 380094994, 3800009849, 3800013469, 3800015068, 3800015967, 3","7066 units","Blood product, which was collected from a donor in which donor suitability was not adequately determined, was distributed.",9/1/2009,"09/01/2009",3/6/2013,"03/06/2013"
"Biologics",54061,"Terminated","CSL Plasma, Inc.","Tempe","AZ","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","US: Illinois. International: Switzerland and Germany.","B-2176-13","Class II","Source Plasma","4270131198 4270126026 4270125650 4270124675 4270123899 4270123349 4270120829 4270120275 4270119111 4270118841 4270117389 4270116685 4270116205 4270114575 4270113536 4270112879 4270112068 4270111435 4270110678 4270109408 4270108850 4270107652 4270107163 4270104462 4270104089 4270102250 4270101577 4270101081 4270099507 4270098917 4270097255 4270096380 4270095330 ",".","33","Blood products, collected from a donor whose scheduled physical examination was incomplete, were distributed. ",10/1/2009,"10/01/2009",9/18/2013,"09/18/2013"
"Biologics",54065,"Terminated","Talecris Plasma Resources, Inc.","Research Triangle Park","NC","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","IL, CA","B-1023-13","Class II","Source Plasma","4240016562 4240016227 4240015380 4240019033 4240017662 4240017149 4240016718 4240016220 4240015901 4240030578 4240030110 4240016888 4240016386 4240015849 4240031050 4240030277 4240029767 4240029010 4240027582 4240026960 4240026400 4240025974 4240025449 4240023612 4240021904 4240020798 4240019172 4240018309 4240017985 4240031664 4240030930 4240030040 4240029138 4240028890 4240027868 4240027424 4240026619 4240025983 4240025072 4240024643 4240024006 4240023727 4240022978 4240022487 4240022051 4240021532 4240021026 4240020416 4240019859 4240018893 4240018118 4240017413 4240017098 4240031569 4240031145 4240022279 4240021514 4240020986 4240020217 4240019301 4240018474 4240024389 4240023957 4240023324 4240022314 4240021943 4240020942 4240020343 4240017705 4240017037 4240016854 4240016974 4240016003 4240031444 4240030845 4240030296 4240029609 4240029159 4240028483 4240028008 4240027314 4240026695 4240025384 4240024794 4240024300 4240023723 4240023240 4240022725 4240022260 4240021740 4240021248 4240020715 4240019773 4240019229 4240018847 4240017527 4240017196 4240015773 4240015201 4240028382 4240027207 4240026812 4240025011 4240024238 4240023782 4240023276 4240022528 4240022215 4240021646 4240019351 4240017364 4240016660 4240015994 4240018750 4240018439 4240020270 4240019348 4240018999 4240018453 4240018146 4240017498 4240017506 4240016406 4240015740 4240024979 4240024268 4240023664 4240022810 4240022245 4240021855 4240021278 4240020674 4240020299 4240015135 4240018949 4240018538 4240017921 4240017763 4240017128 4240022320 4240021553 4240020538 4240019964 4240018725 4240018177 4240017849 4240017396 4240017141 4240032046 4240031443 4240030744 4240030299 4240029608 4240029165 4240028482 4240028007 4240027315 4240026696 4240025246 4240024818 4240023728 4240023109 4240022717 4240022119 4240021732 4240021124 4240020712 4240020135 4240019780 4240019231 424001",,"291","Blood products, collected from a donor whose scheduled physical examination was incomplete, were distributed.",11/6/2009,"11/06/2009",5/8/2013,"05/08/2013"
"Biologics",54067,"Terminated","Talecris Plasma Resources, Inc.","Research Triangle Park","NC","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","NC, CA","B-1117-13","Class II","Source Plasma","5090011060 5090010338 5090019665 5090019435 5090017266 5090016755 5090016499 5090013137 5090012145 5090010621 5090009573 5090019647 5090019305 5090018810 5090018523 5090018545 5090017961 5090016116 5090025472 5090024995 5090023820 5090023303 5090017822 5090017009 5090016695 5090015129 5090014746 5090027102 5090026966 5090023844 5090023460 5090022964 5090021841 5090019671 5090019323 5090018846 5090018518 5090017967 5090017511 5090017149 5090015286 5090014719 5090014044 5090025510 5090025051 5090024528 5090024156 5090023662 5090023409 5090022849 5090022500 5090022051 5090021751 5090021244 5090020947 5090020426 5090019963 5090019534 5090018965 5090018790 5090018154 5090017938 5090017423 5090017089 5090016643 5090016309 5090015801 5090015405 5090015094 5090014544 5090013529 5090013235 5090012813 5090012533 5090012121 5090011571 5090010944 5090010503 5090010113 5090009894 5090019085 5090018625 5090017594 5090017298 5090017750 5090014247 5090013229 5090019211 5090018819 5090018370 5090018032 5090012959 5090010646 5090019135 5090018867 5090014895 5090020605 5090020277 5090019645 5090019418 5090018607 5090016943 5090016336 5090015929 5090011270 5090010680 5090020155 5090018961 5090018767 5090022573 5090021411 5090013972 5090013713 5090013308 5090016958 5090016422 5090015988 5090012477 5090011395 5090011209 5090010719 5090010354 5090009919 5090009679 5090013017 5090012624 5090011547 5090011135 5090026400 5090026294 5090016739 5090016255 5090015936 5090015200 5090024650 5090024382 5090022061 5090020181 5090019664 5090018711 5090027826 5090025313 5090024028 5090023365 5090023022 5090015927 5090012216 5090023362 5090022859 5090021749 5090020846 5090020405 5090019560 5090018999 5090017832 5090017382 5090024411 5090023887 5090022638 5090022198 5090021892 5090021332 5090021019 5090017493 5090017166 5090021810 5090020902 5090020566 5090020114 5090019594 5090019147 5090018658 5090018268 5090017819 5090017139 5090011195 5090012570 5090012273 5090011907 5090011473 5090010259 5090009533 5090001548 5090000948 5090000547 5090000309",,"1504","Blood products, collected from a donor whose scheduled physical examination was incomplete, were distributed.",11/28/2009,"11/28/2009",5/22/2013,"05/22/2013"
"Biologics",54211,"Terminated","Talercris Plasma Resources, Inc.","Greenville","SC","US","Voluntary: Firm Initiated","Letter","NC","B-0057-14","Class III","Source Plasma","3590016002, 3590021668, 3590022785, 3590000240, 3590023613, 3590023941, 3590017527, 3590018181, 3590018916, 3590022690, 3590023013, 3590014854, 3590015970, 3590016712, 3590020289, 3590022447, 3590017463, 3590018993, 3590022352, 3590026746, 3590017453, 3590018487, 3590019512, 3590019636, 3590017201, 3590020313, 3590020142, 3590022234, 3590019687, 3590023098, 3590000219, 3590017352, 3590018201, 3590018422, 3590018735, 3590019766, 3590020403, 3590014433, 3590015114, 3590022965, 3590020592, 3590023754, 3590023892, 3590016729, 3590018222, 3590016290, 3590016785, 3590017487, 3590018260, 359025223, 359024683, 359021720, 3590014414, 3590014662, 3590017746, 3590017933, 359025087, 3590017717, 3590017929, 3590018454, 3590024267, 3590024826, 3590025110, 3590027523, 3590017433, 3590018857, 3590025029, 3590016745, 3590017443, 3590017718, 3590018228, 3590021123, 3590023740, 3590024562, 359030173, 359030916, 359029448, 359028972, 359028849, 359028567, 359027857, 359027660, 359027155, 359024257, 359022709, 3590019524, 3590018998, 3590026199, 3590026090, 3590025039, 3590026248, 3590022336, 3590027577, 3590024526, 3590027259, 3590019544, 3590017358, 3590016814, 3590017877, 3590016811, 3590018231, 3590019507, 3590025031, 3590025984, 3590016707, 3590017980, 3590022848, 3590023398, 3590023616, 3590002519, 3590003657, 3590015071, 359030256, 359030968, 359026358, 3590014408, 3590015093, 3590016405, 3590016912, 3590018452, 3590021844, 3590024006, 3590023429, 3590021741, 3590023767, 3590023970, 3590024272, 3590017394, 3590025034, 3590026616, 3590018206, 3590022470, 3590020353, 3590018480, 3590020286, 3590022360, 3590025657, 3590027202, 359030934, 359028164, 359025177, 359023078, 359021877, 3590017843, 3590023057, 3590024429, 3590018438, 3590022717, 3590016773, 3590023468, 3590017840, 3590022385, 3590022887, 3590019451, 3590025832, 3590027684, 3590017922, 3590016067, 3590019755, 3590023431, 3590016338, 3590016732, 3590023907, 3590016252, 3590016859, 3590017128, 3590017986, 3590027282, 3590027609, 3590019566, 3590020578, 3590017520, 3590",".","861","Blood products, collected from donors whose suitability was not adequately determined, were distributed.",9/29/2009,"09/29/2009",12/4/2013,"12/04/2013"
"Biologics",54938,"Terminated","Talecris Plasma Resources, Inc.","Research Triangle Park","NC","US","Voluntary: Firm Initiated","FAX","NC, CA","B-1022-13","Class II","Source Plasma","4240013647;4240013121;4240012766;4240012300; 4240012033;4240011179;4240010766;4240010449; 4240006845;4240026822;4240018069;4240017563; 4240017259;4240016368;4240015639;4240015315; 4240014793;4240014514;4240010109 ,4240009093 , 4240008806 ,4240008423 ,4240008143 ,4240007781 , 4240007410 ,4240007180 ,4240006880 ,4240022328 , 4240021971 ,4240011906 ,4240010160 ,4240009557 , 4240008949 ,4240008764 ,4240007707 ,4240006878 ",,"36","Blood products, collected from a donor whose scheduled physical examination was incomplete, were distributed.",12/14/2009,"12/14/2009",5/8/2013,"05/08/2013"
"Biologics",54939,"Terminated","Blood Bank of Alaska, Inc.","Anchorage","AK","US","Voluntary: Firm Initiated","Letter","New York, Alaska, Louisiana, and Texas.","B-0812-13","Class III","Red Blood Cells Leukocytes Reduced Irradiated","W066509658119, W066509675793, W066509677433; W06650975802",,"4 components","Blood products, collected from a donor in which donor suitability was not adequately determined, were distributed..",1/7/2010,"01/07/2010",5/8/2013,"05/08/2013"
"Biologics",54939,"Terminated","Blood Bank of Alaska, Inc.","Anchorage","AK","US","Voluntary: Firm Initiated","Letter","New York, Alaska, Louisiana, and Texas.","B-0811-13","Class III","Red Blood Cells Leukocytes Reduced","W066509675798, W066509675749, W066509675728, W066509657517, W066509657518, W066509657532, W066509675814, W066509678095, W066509677794, W066509677801, W066509658117, W066509657524, W066509657540, W066509657556, W066509675781, W066509675730, W066509675741, W066509677810, W066509677815, W066509677433, W066509657515, W066509657558, W066509675892, W066S09675808, W066509675793 , W066509675802, W066509675804, W066509657532, W066509675692, W066509658672, W066509658119.",,"31 components","Blood products, collected from a donor in which donor suitability was not adequately determined, were distributed..",1/7/2010,"01/07/2010",5/8/2013,"05/08/2013"
"Biologics",54946,"Terminated","Blood Systems, Inc","Billings","MT","US","Voluntary: Firm Initiated","FAX","CA, MT, WY, MS, CO, SD, TX, NV, AR","B-0664-13","Class II","Cryoprecipitated AHF","W04230903945900A, W042309041794002, W04230904353400A, W042309048028003, W042309048037001, W04230905009000D, W04230905054000U, W04230905457700E, W04230905753400P, W042309057809003, W042309057833003, W042309062051000, W04230906206400R, W04230906215500L, W04230900651700I, W04230900652100Q, W042309006538008, W042309006562008, W042309006570008, W04230900658300Z, W04230900658400X, W04230900740100Q, W042309011086006, W042309011087004, W04230901109800Z, W042309012535009, W042309012538003, W042309012545005, W04230901256800S, W04230901348500I, W04230901349200K, W042309013498008, W042309013505005, W04230901351600*, W04230903946300I, W04230903947000K, W04230903948200C, W042309039484008, W042309039486004, W04230903987000P, W04230903987500F, W04230903989200D, W04230904070400H, W04230904171600U, W04230904175300K, W042309041769004, W042309041779000, W042309041785004 , W042309041800001, W04230904251700S, W04230904252400U, W04230904252900K, W04230904254000U, W04230904352400E, W042309043528006, W042309043553004, W04230904543400N, W04230904609100L, W04230904610000E, W042309046107000, W04230904612500X, W04230904613700P, W04230904615200R, W04230904615900D, W04230904616700D, W04230904617000N, W04230904617400F, W042309046177009, W042309046179005, W04230904705000N, W04230904707000F, W04230904711900D, W04230904784700N, W04230904785500N, W04230904786400L, W04230904787400H, W042309047897003, W04230904789900* , W04230904801200J, W04230904801600B, W042309048033009, W042309048044003, W04230904804800W, W04230904864600P, W04230904865300R, W042309050012004, W042309050086005, W042309050094005, W042309050100004, W04230905014500F, W042309050156009, W042309050165007, W04230905017100B, W04230905054800E, W04230905140600Q, W04230905144200I, W04230905147700X, W042309054450007, W04230905445900Q, W04230905484100E, W04230905484900Z, W042309054855002, W04230905585500N, W04230905586300N, W04230905631400S, W04230905632400O, W04230905632600K, W04230905752500R, W042309057921003, W0423090",,"112 components","Blood products, which were collected from a donor in which donor suitability was not adequately determined, were distributed..",1/8/2010,"01/08/2010",4/3/2013,"04/03/2013"
"Biologics",54946,"Terminated","Blood Systems, Inc","Billings","MT","US","Voluntary: Firm Initiated","FAX","CA, MT, WY, MS, CO, SD, TX, NV, AR","B-0669-13","Class II","Red Blood Cells (Apheresis) Leukocytes Reduced Irradiated","W04230906345300M , W04230906239600O , W04230906345600G.",,"3 components","Blood products, which were collected from a donor in which donor suitability was not adequately determined, were distributed.",1/8/2010,"01/08/2010",4/3/2013,"04/03/2013"
"Biologics",54946,"Terminated","Blood Systems, Inc","Billings","MT","US","Voluntary: Firm Initiated","FAX","CA, MT, WY, MS, CO, SD, TX, NV, AR","B-0663-13","Class II","Red Blood Cells Leukocytes Reduced","W04230903733800N, W04230903734700L, W04230903735000V, W042309037369009, W04230903738000J, W04230903794300I, W04230903795000K, W042309037956008, W042309037967002, W04230903797000C, W042309037975002, W04230903797800X, W042309037980008, W04230903803600Z, W04230906124500X, W04230906125600R, W04230906126600N, W04230906139800*, W04230906339100I, W04230906347200G, W042309063476008, W04230906377900F, W042309037231008, W04230903730800Z, W042309037315000, W042309037331000, W04230903803000A, W04230905301900G, W04230906074300D, W042309060747005, W04230906075200B, W042309061231008, W04230906133400V, W04230906133700P, W042309061386007, W042309061393009, W04230906191700M, W04230906195000K, W042309061967002, W04230906197900V, W04230906239800K, W04230906281100Q, W04230906281400K, W04230906320100P, W04230906320500H, W042309063228003, W04230906365900V.",,"47 components","Blood products, which were collected from a donor in which donor suitability was not adequately determined, were distributed..",1/8/2010,"01/08/2010",4/3/2013,"04/03/2013"
"Biologics",54946,"Terminated","Blood Systems, Inc","Billings","MT","US","Voluntary: Firm Initiated","FAX","CA, MT, WY, MS, CO, SD, TX, NV, AR","B-0666-13","Class II","Fresh Frozen Plasma","W04230900860500N , W042309010963001 , W04230901112000Y , W04230901181100H , W04230901351700Y , W042309041019006 , W04230904319800A , W04230904454800J , W04230904455800F , W04230904456700D , W04230904800700D , W04230905001700V , W04230905059700X , W04230905198500U , W04230905314800Z , W042309054782004 , W04230905502400R , W04230905944900O , W04230905956800A , W04230906003700S , W04230906191700M , W04230906195000K , W04230906212400Z , W04230906239800K , W04230906281100Q , W04230906281400K , 234630646, 234630655, 234631087, W042308037694000, W04230905140900K, W04230803972800H , W04230804145300O , W04230804145500K , W04230804265000Z , W04230900657700V , W04230900762300Z , W04230900764300R , W04230900764800H , W04230900772500N , W04230900862100N , W042309008799008 , W04230901010200H , W042309010106009 , W042309010122009 , W042309010446006 , W04230901049900H , W04230901065800J , W042309010689005 , W042309010971001 , W04230901180300H , W042309011808007 , W042309011817005 , W04230901182200B , W042309011826003 , W04230901186500Q , W04230901188800C , W04230901189400G , W042309011912007 , W04230901191700Y , W04230901376900V , W04230901377800T , W04230901378400X , W04230903900500X , W04230903945800C , W04230903946500E , W04230904021200K , W04230904034300Z , W04230904035700N , W04230904035900J , W04230904036400P , W04230904037800D , W04230904072300B , W04230904212400P , W042309042149007 , W04230904236300W , W04230904238900C , W04230904263000Q , W04230904270000U , W04230904317100W , W04230904318700G , W04230904318900C , W04230904319200M , W04230904319700C , W04230904324600Q , W04230904326200Q , W04230904356600V , W04230904357400V , W04230904392000R , W04230904393100L , W04230904396900U , W04230904452700T , W04230904452900P , W04230904453500T , W04230904453800N , W04230904454000Z , W04230904455100T , W042309045064006 , W04230904511000Q , W042309045152006 , W042309045161004 , W042309045163000 , W04230904517400V , W04230904518100X",,"163 components","Blood products, which were collected from a donor in which donor suitability was not adequately determined, were distributed.",1/8/2010,"01/08/2010",4/3/2013,"04/03/2013"
"Biologics",54946,"Terminated","Blood Systems, Inc","Billings","MT","US","Voluntary: Firm Initiated","FAX","CA, MT, WY, MS, CO, SD, TX, NV, AR","B-0670-13","Class II","Fresh Frozen Plasma (Apheresis)","W042309011078006 , W04230904071300F , W04230904071300F , W042309041704001 , W04230904174600I , W04230904174600I , W04230904800400J , W04230905584300V , W04230905585900F , W042309062042002 , W042309062042002 , W04230906210100C , W04230906210100C , W04230906212900P , W04230800018300W, W04230800331700P, W04230803557400B, W04230803557400B, W04230803982000P, W042308042036005, W04230804206600U, , W04230804291100P , W04230804291100P , W04230900650400S , W04230901022300* , W04230901022300* , W04230901022300* , W04230901348900A , W04230901348900A , W042309041704001 , W042309041704001 , W04230904174600I , W042309043546002 , W04230904452400Z , W04230904452400Z , W04230904543200R , W04230904543200R , W04230904565800S , W04230904565800S , W04230904567400S , W04230904567400S , W04230904711400N , W04230904711400N , W04230904800400J , W042309048035005 , W042309048035005 , W04230904865200T , W04230904866100R , W04230904866100R , W04230904866100R , W042309050078005 , W042309050078005 , W04230905140700O , W04230905140700O , W04230905144000M , W042309051474002 , W042309051474002 , W04230905148700T , W04230905444800W , W04230905584300V , W04230905585900F , W04230905585900F , W04230905585900F , W04230905587200L , W04230905587200L , W04230905587200L , W04230905782800Y , W04230905782800Y , W04230905977600V , W04230905977600V , W04230906209200J , W04230906209200J , 234625823, 234630647, 234630647, 234630647, 234631073, 234631073, 234631073, 234634505, 234634505, W04230800174500H, W04230800175100L, W04230800175100L, W04230800330400Z, W04230800330400Z, W04230800330400Z, W04230800331700P, W04230800331700P, W04230800643900V, W04230800418900U, W042308035495009, W042308039374000, W04230803982000P, W042308042036005, W04230804206600U.",,"96 components","Blood products, which were collected from a donor in which donor suitability was not adequately determined, were distributed.",1/8/2010,"01/08/2010",4/3/2013,"04/03/2013"
"Biologics",54946,"Terminated","Blood Systems, Inc","Billings","MT","US","Voluntary: Firm Initiated","FAX","CA, MT, WY, MS, CO, SD, TX, NV, AR","B-0668-13","Class II","Red Blood Cells (Apheresis)","W042309063726004 , W042309063726004 , W04230906376600P , W04230906376600P , W04230906379500F , W04230906379500F.",,"6 components","Blood products, which were collected from a donor in which donor suitability was not adequately determined, were distributed.",1/8/2010,"01/08/2010",4/3/2013,"04/03/2013"
"Biologics",54946,"Terminated","Blood Systems, Inc","Billings","MT","US","Voluntary: Firm Initiated","FAX","CA, MT, WY, MS, CO, SD, TX, NV, AR","B-0665-13","Class III","Blood and Blood Products for Reprocessing","W04230804145700G , W04230804146600E , W042308041469008 , W04230804264200Z , W04230804265700L , W04230804270900T , W04230804271400Z , W042308042794003 , W04230804287800W , W042308042880007 , W042308042890003 , W04230804289800O , W04230900651700I , W04230900652100Q , W042309006538008 , W042309006562008 , W042309006570008 , W04230900658300Z , W04230900658400X , W04230900659300V , W04230900735000G , W04230900739700N , W04230900740100Q , W04230900762700R , W04230900771200X , W04230900774000P , W042309007748009 , W04230900775100J , W04230900819800L , W04230900831200C , W04230900832100A , W042309008325002 , W042309008332004 , W04230900833800T , W042309008340004 , W042309008341002 , W04230900834700R , W042309008350000 , W04230900835600P , W04230900835800L , W042309008412004 , W04230900860200T , W04230900860900F , W04230900861200P , W04230900861800D , W04230900862500F , W042309008628009 , W042309008840001 , W04230900886300O , W04230900887200M , W042309008887008 , W042309009125002 , W04230900912800X , W04230900915200X , W04230900915800L , W04230900916300R , W042309010051007 , W04230901006800Q , W04230901009000U , W04230901009600I , W042309010126001 , W042309010133003 , W042309010140005 , W04230901014600U , W042309010230001 , W04230901044300C , W04230901045100C , W042309010457000 , W042309010462006 , W04230901046900T , W042309010470006 , W042309010480002 , W04230901050700C , W04230901051100K , W04230901051500C , W042309010528002 , W04230901053100C , W042309010537000 , W042309010543004 , W042309010552002 , W042309010560002 , W04230901056600R , W04230901058800F , W04230901059800B , W04230901064700P , W04230901065000Z , W04230901066100T , W04230901068100L , W04230901094800* , W04230901094900Y , W042309010960007 , W042309010961005 , W04230901096500Y , W04230901096700U , W04230901096900Q , W042309011086006 , W042309011087004 , W04230901109800Z , W04230901110300* , W042309011110001 , W04230901111300W , W04230901112300S , W04230901171100P , W04230901171500H , W04230901172000N , W04230901172600B , W04230901173200F , W04230901180",,"610 components","Blood products, which were collected from a donor in which donor suitability was not adequately determined, were distributed.",1/8/2010,"01/08/2010",4/3/2013,"04/03/2013"
"Biologics",54946,"Terminated","Blood Systems, Inc","Billings","MT","US","Voluntary: Firm Initiated","FAX","CA, MT, WY, MS, CO, SD, TX, NV, AR","B-0667-13","Class II","Red Blood Cells Leukocytes Reduced Irradiated","W042309061251000, W04230906126200V, W04230906324900U.",,"3 components","Blood products, which were collected from a donor in which donor suitability was not adequately determined, were distributed.",1/8/2010,"01/08/2010",4/3/2013,"04/03/2013"
"Biologics",54946,"Terminated","Blood Systems, Inc","Billings","MT","US","Voluntary: Firm Initiated","FAX","CA, MT, WY, MS, CO, SD, TX, NV, AR","B-0662-13","Class II","Red Blood Cells (Apheresis) Leukocytes Reduced","W042309037311008 , W042309037311008 , W04230903736500H , W04230903736500H , W042309060749001 , W042309063237001 , W042309060749001 , W042309061224006 , W042309061224006 , W04230906193800C , W04230906193800C , W04230906239600O , W04230906280300Q , W042309063237001 , W04230906345900A , W04230906357100A.",,"16 components","Blood products, which were collected from a donor in which donor suitability was not adequately determined, were distributed.",1/8/2010,"01/08/2010",4/3/2013,"04/03/2013"
"Biologics",54946,"Terminated","Blood Systems, Inc","Billings","MT","US","Voluntary: Firm Initiated","FAX","CA, MT, WY, MS, CO, SD, TX, NV, AR","B-0661-13","Class II","Plasma Frozen Cryoprecipitate Reduced","W04230905631400S",,"1 component","Blood products, which were collected from a donor in which donor suitability was not adequately determined, were distributed.",1/8/2010,"01/08/2010",4/3/2013,"04/03/2013"
"Biologics",54953,"Terminated","CSL Plasma, Inc.","Boca Raton","FL","US","Voluntary: Firm Initiated","E-Mail","Illinois, North Carolina, California, Germany, Switzerland, and England.","B-1118-13","Class II","Source Plasma","0550714031; 0550707898; 0550703257; 0550701001; 0550700271; 0550642393; 0550840775; 0550839511; 0550838865; 0550837444; 0550836705; 0550832513; 0550831053; 0550830130; 0550827079; 0550824869; 0550824214; 0550822892; 0550822106; 0550817357; 0550815598; 0550814986; 0550813249; 0550812388; 0550810967; 0550810105; 0550807402; 0550806425; 0550804679; 0550797903; 0550795059; 0550794450; 0550787218; 0550786385; 0550719996; 0550706561; 0550705373; 0550703839; 0550702722; 0550701675; 0550700484; 0550699347; 0550698067; 0550697346; 0550695879; 0550695123; 0550693506; 0550692919; 0550552609; 0550547819; 0550547323; 0550545129; 0550544636; 0550543696; 0550543036; 0550540333; 0550539557; 0550538346; 0550537062; 550535634; 0550534986; 0550534121; 0550533578; 0550531861; 0550531521; 0550530387; 0550529453; 0550528730; 0550528091; 0550527115; 0550526756; 0550525864; 0550525506; 0550524605; 0550524145; 0550523170; 0550522777; 0550521729; 0550521251; 0550520365; 0550519898; 0550533173; 0550532434; 0550530266; 0550529679; 0550506032; 0550505522; 0550504178; 0550503469; 0550507322; 0550506939; 0550445464; 0550444686; 0550444248; 0550434029; 0550433635; 0550432810; 0550431296; 0550430426; 0550429995; 0550429167; 0550428766; 0550426388; 15178145; 15169617; 15165497; 15156938; 15152640; 15144539; 15140654; 15133243; 15129208; 15121561; 15117328; 15109521; 15094278; 15063410; 15059338; 15052469; 15048936; 15042118; 15038838; 0550489473; 0550489147; 0550488307; 0550487841; 66023104; 66015598; 66009405; 65994399; 65989470; 65984765; 65980682; 65994504; 96392607; 96383278; 96082805; 96075999; 96073186; 96066805; 96063606; 96046753; 96043653; 96036181; 96033203; 96025970; 96023242; 96016510; 96014240; 96006467; 96003060; 81541133; 81535828; 81529087; 81526086; 81518975; 81515837; 81509355; 81505401; 81498512; 81495177; 81488193; 81484850; 81478019; 81474110; 65983928; 66145356; 66138488; 66132752; 66127314; 66120841; 66113683; 66107545; 66097815; 66094616; 66087885; 66060499; 66048053; 66042068; 66033851; 66015185; 66012092; 66002512; 6",,"337 units","Blood products, collected from donors who were previously deferred, were distributed.",2/10/2010,"02/10/2010",5/22/2013,"05/22/2013"
"Biologics",54954,"Terminated","CSL Plasma, Inc.","Tempe","AZ","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","CA, IL, NC, NJ, Switzerland and Germany.","B-2034-13","Class III","Source Plasma","13183523 ;13175085 ;13168735 ;13161873 ; 13149529 ;13144951 ;13136185 ;13131777 ; 13123475 ;13110871 ;13105921 ;13096656 ; 13088040 ;13083311 ;13073510 ; 13068509 ; 13027452 ;13023836 ;0480863161 ; 0480872491 ;0480872084 ;0480871308 ;0480870930 ; 0480870268 ; 0480869890 ;0480869143 ;0480868789 ; 0480868054 ;0480867534 ;0480867025 ;0480866515 ; 0480865237 ; 0480864907 ;0480864154 ;0480863894 ; 0480862557 ; 0480862298 ;0480861467 ;0480881859 ; 0480880481 ;0480879724 ;0480879366 ;0480878258 ; 0480877707 ;0480877131 ;0480875972 ;0480875628 ; 0480874747 ;0480874378 ;0480873585 ;0480873205 ; 0480861323 ;0480860355 ;0480859923 ;0480859426; 0480858986 ; 0480857978 ;0480857477 ;0480856894 ; 0480856331 ;0480855781 ;0480855229 ;0480854676 ; 0480853956 ;0480853534 ;0480852997 ;0480852580 ; 0480852001 ; 0480851664 ;0480850951 ;0480850573 ; 0480848998 ;0480848605 ;0480847868 ;0480847493 ; 0480849762 ;0480852457 ;0480852038 ;0480848373; 0480846132 ; 13109585 ;13086824 ;13082857 ; 13068646 ; 86324588 ;86285230 ;86204088 ; ;86185325 ; 86171977 ;86165532 ;86161671 ; 86147484 ; 86138185 ;86122276 ;86102179; ;80961192 ; 80943235 ;80938583 ;80928379 ; 80925460 ;80900436 ;65875049 ;65797235 ;65780022 ; 65757802 ;65753354 ;65732052 ; 65724156 ; 65717882 ;65706084 ;65694251 ; 65684597 ; 65676103 ; 65671535 ;65663028 ; 65656310 ;65649947 ;65643594 ;65635766 ; 0481007406 ;0480986861 ;480890238 ;0480889011 ; 0480888607 ;0480887691 ;86375290 ;86359535 ; 86356183 ;86332286 ;86328654 ;86316026 ; 86309769 ;86300384 ;86296274 ;86286039 ; 86279284 ;86267984 ;86254090 ;86250436 ; 86228442 ;86221566 ; 86213585 ;81013395 ;81005192 ;80972679 ; 80966203 ;80958604 ; 80947448 ;80921721 ;80917496 ;80905516 ; ;17242860, 17234887, 17227049, 17223256, 17215084, 17210447, 17201957, 13297640, 13289461, 13232851, 13276447, 13270699; 0480879724 ;0480879366 ; 0480877131 ;0480878258 ; 0480877707; 0480875972 ;0480875628 ;0480874747 ; 0480874378 ;0480873585 ;0480873205 ;0480861323 ; 0480860355 ;0480859923 ;048085",".","191","Blood products, collected from donors who were permanently deferred, were distributed. ",2/4/2010,"02/04/2010",9/18/2013,"09/18/2013"
"Biologics",54959,"Terminated","CSL Plasma, Inc.","Fort Worth","TX","US","Voluntary: Firm Initiated","E-Mail","IL, Germany, Switzerland","B-1560-13","Class III","Source Plasma","4190070246;4190069532;4190069192;4190027129;4190026840;4190026121;4190025997;4190025272;4190024519;4190024119;4190023368;4190023222;4190017364;4190016544;4190016270;4190015917;4190015709;4190015318;4190015102;4190014641;4190014263;4190014099;4190013711;4190013478;4190013121;4190012934;4190012550;4190012358;4190081815;4190080585;4190080216;4190079168;4190078417;4190077735;4190077089;4190076142;4190075613;4190074971;4190074511;4190073983;4190072666;4190072341;4190071308;4190069854;4190069408;4190068507;4190068082;4190067326;4190066902;4190066244;4190065743;4190064942;4190064667;4190063980;4190063661;4190062560;4190062010;4190061360;4190060923;4190060380;4190059961;4190059491;4190059058;4190058581;4190058157;4190057508;4190057160;4190056551;4190056074;4190055667;4190055221;4190054530;4190053927;4190053665;4190052787;4190052555",,"76 units","Blood products, collected from donors who were permanently deferred, were distributed.",2/1/2010,"02/01/2010",7/31/2013,"07/31/2013"
"Biologics",54960,"Terminated","CSL Plasma, Inc.","Oklahoma City","OK","US","Voluntary: Firm Initiated","FAX","IL, Germany, Switzerland","B-0284-13","Class II","Source Plasma","4220524051, 4220494958, 4220494293, 4220491853, 4220489422, 4220487129, 4220486475, 4220484309, 4220483659, 4220481231, 4220480399, 4220478728, 4220477840, 4220475733, 4220474704, 4220472654, 4220471314, 4220444494, 4220443659, 4220441380, 4220438250, 4220435898, 4220434960, 4220432970, 4220432061, 4220430182, 4220429369, 4220427170, 4220424871, 4220424060, 4220422093, 4220421302, 4220419533, 4220418804, 4220417064, 4220416438, 4220414286, 4220412438, 4220411684, 4220409165, 4220408380, 4220406850, 4220361334, 4220360279, 22BJSXJX, 22BJSWSB, 22BJSTQH, 22BJSTDM, 22BJPWZT, 22BJRVCR, 22GBTRMZ, 22GBTRDV, 22GBTQGW, 22GBTPXV, 22GBTHMR, 22GBQYBT, 22GBQXQJ, 22GBQWVZ, 22GBQWKK, 22GBQTHM, 22GBQSVT, 22GBRFGD, 22GBRDVY, 22GBRCTD, 22GBRBZX, 22GBKVGJ, 22GBKTPV, 22GBKRPK, 22GBKQJH, 22GBKPJB, 22GBKLYT, 22GBKKZZ, 22GBKKKT, 22GBKJNX, 22GBKGXH, 22GBKFTG, 22GBKFGB, 22GBKCSG, 22GBJYQW, 22GBJXZM, 22GBBNVK, 22GBBMZC, 22GBBFQK, 22GBBKLJ, 22GBBHNR, 22GBBDZC, 22GBBBKB, 22BJWWZT, 22BJVZWT, 22BJVWJY, 22BJVVVQ, 22BJVVFN, 22BJVTQK, 22BJTSKT, 22BJTRXW, 22BJTRJX, 22BJTPKW, 22BJTPCW, 22BJSPSF, 22BJSNRD, 22BJQLPC, 22BJQHZX, 22BJQHHQ, 22BJQFSR, 22BJQFBG, 22BJQDDC, 22BJQCNX, 22BJQBPG, 22HJQYDG, 22HJQWZH",".","110 units","Blood products, collected from donors who were previously deferred for high risk behavior, were distributed.",2/12/2010,"02/12/2010",2/6/2013,"02/06/2013"
"Biologics",54961,"Terminated","CSL Plasma, Inc.","Tempe","AZ","US","Voluntary: Firm Initiated","FAX","Illinois, Switzerland, Germany, California","B-1792-13","Class III","Source Plasma","4270184198 ;4270183448 ;4270179635 ;4270175391 ; 4270174464 ;4270168950 ;4270167538 ;4270166525 ; 4270162628 ;4270162160 ;4270159773 ;4270138087 ; 4270133013 ;4270114669 ;4270113260 ;4270111020 ; 4270109932 ;4270109507 ;4270012058 ;4270011007 ; 4270010201 ;4270008634 ;4270008244 ;4270008090 ; 4270332403 ;4270331378 ;4270328816 ;4270327720 ; 4270323319 ;4270321643 ;4270321171 ;4270318101 ; 4270317314 ;4270314489 ;4270310059 ;4270303513 ; 4270302528 ;4270300513 ;4270282182 ;4270253496 ; 4270252636 ;4270250858 ;4270248635 ;4270247679 ; 4270246438 ;4270245375 ;4270244076 ;4270243129 ; 4270241947 ;4270240896 ;4270239538 ;4270238243 ; 4270236862 ;4270235925 ;4270002930 ;4270002748 ; 4270007489 ;4270007388 ;4270006699 ;4270006535 ; 4270006296 ;4270002930 ;4270002748 ;4270004302 27DFYCFL 27DFYBWH , 27DFYBDH ,27DFXZQN ,27DFXYYN, 27DFNLBY ,27DFNJDW ,27DFLRDY, 27 HTBNJG, 27HTBNBN , 27HTBLVL, 27HTBKZW, 27HTBKQZ, 27HTBJZJ, 27HTBJQP, 27HTBHTG ,27HTBHMS, 27HTBGVZ, 27 DFZPKS, 27DFZNTH 27DFZNKZ ,27DFZMTP, 27DFZMPP, 27DFZLTY, 27DFZLMY, 27DFZKVR, 27DFZKMP, 27DFYWJJ, 27DFYVPX, 27DFYVFK, 27DFYFCV, 27DFYDVP, 27DFYDGP, 27DFYCWP, 27DFXYPQ, 27DFXXXV ,27DFXXMY, 27DFXVSM, 27 DFXVKJ, 27DFWXCF 27DFWWBR ,27DFWVBX ,27DFWTPJ ,27DFWTCV ,27DFWSHV , 27DFWSBR ,27DFWRHN ,27DFWQQS ,27DFWPRC ,27DFWBTT , 27DFWBQH ,27DFVXNP ,27DFVXDG ,27DFVWKT ,27DFVWBD , 27DFVVHL ,27DFVTVV ,27DFVSYC ,27DFVSMV ,27DFTXQS , 27DFVQXQ ,27DFQWRH ,27DFQWFR ,27DFQVLB ,27DFQTZS , 27DFQSVK ,27DFQRXZ ,27DFQRLH ,27DFQQQT ,27DFQQDR , 27DFQPGN ,27DFQNNG ,27DFQMYP ,27DFQMHD ,27 ,DFQLRF , 27DFQKZD ,27DFQKLL ,27DFQJWJ ,27DFQJJG ,27DFQHTN , 27DFPXZZ ,27DFPXRV ,27DFPWXX ,27DFPWRC ,27DFPTRX , 27DFPTKV ,27DFPVYH ,27DFPRVD ,27DFPRJX ,27DFPQRM , 27DFPQDQ ,27DFNQZC ,27DFNQHG ,27DFNPWY ,27DFNPFJ ,27DFNNTS ,27FNNFW ,27DFNMTY ,27DFNMHP ,27DFNLWX , 27DFNLJF ,27DFNJLM ,27DFMXKX ,27DFMXDV ,27DFLYQQ , 27DFLYKW ,27DFLXTX ,27DFLXNH ,27DFLWXZ ,27DFLWQR , 27DFLWBJ ,27DFLVSR ,27DFLVBJ ,27DFLTNK ,27DFLSYT , 27DFLSGN ,27DFLRTW ,27HTGBRS ,27HTGBDV ,27DFTQHL ",".","245","Blood products, collected from donors who were permanently deferred, were distributed. ",2/2/2010,"02/02/2010",9/18/2013,"09/18/2013"
"Biologics",54963,"Terminated","CSL Plasma, Inc.","Boca Raton","FL","US","Voluntary: Firm Initiated","FAX","Illinois.","B-0705-13","Class III","Source Plasma","79691994, 79688918, 79681117, 79669337, 79665902, 79652131, 79643740, 79638296, 79632287, 79626439, 79620741, 79612906, 79605069, 79601085, 79594257, 79587846, 79577717, 79565332, 79556729, 79552424, 79545914, 79533102, 79525572, 79520171, 79512305, 79507509, 79499057, 79493970, 79466837, 51575007, 51560096, 51555603, 51547356, 51542252, 51532291, 51528041, 51518271, 51513498, 51505011, 51500313, 51490287, 51485825, 51462581, 51457266, 51446741, 51441777.",,"46 units","Blood products, which were collected from a donor with a history of high risk behaviors, were distributed.",4/14/2010,"04/14/2010",3/20/2013,"03/20/2013"
"Biologics",54967,"Terminated","CSL Plasma, Inc.","Spokane","WA","US","Voluntary: Firm Initiated","Other","Illinois, North Carolina, and France.","B-0658-13","Class II","Source Plasma","6210346135, 6210344265, 6210335862, 6210335217, 6210333853, 6210333251, 6210329053, 6210327943, 6210326613, 6210325739, 6210324574, 6210321258, 6210310643, 6210306788, 6210305188, 6210301617, 6210299079, 6210298069, 6210294949, 6210293682, 6210287516, 6210284758, 6210283498, 6210282474, 6210278432, 6210276911, 6210275811, 6210274810, 6210273435, 6210347674, 6210347091, 6210346214, 6210345705, 6210344604, 6210343974, 6210335603, 6210334978, 6210333632, 6210333059, 6210331571, 6210328848, 6210327413, 6210326812, 6210325490, 6210324983, 6210323469, 6210322922, 6210321366, 6210320715, 6210319299, 6210318667, 6210317370, 6210316711, 6210315306, 6210314678, 6210313129, 6210312410, 6210310969, 6210310210, 6210309021, 6210308462, 6210307076, 6210306539, 6210304952, 6210304209, 6210302739, 6210302115, 6210300836, 6210300185, 6210298904, 6210298208, 6210296828, 6210296151, 6210294813, 6210294121, 6210292828, 6210292188, 6210290937, 6210290330, 6210288449, 6210286423, 6210285111, 6210284562, 6210283421, 6210282949, 6210282261, 6210281602, 6210280790, 6210280250, 6210279654, 6210277511, 6210276855, 6210275546, 6210274837, 6210273677, 6210273004, 6210271469, 6210270745, 6210269478, 6210268770, 6210267572, 6210266241, 6210265626, 6210264123, 6210263472, 6210256108, 6210255476, 6210254187, 6210253560, 6210252355, 6210251754, 6210250539, 6210250053, 6210248824, 6210248166, 6210246868, 6210246207, 6210241575, 6210240859, 6210239705, 6210239107, 6210237927, 6210237358, 6210236272, 6210235716, 6210234805, 6210234345, 6210233203, 6210232680, 6210231529, 6210230969, 6210229887, 6210229352, 6210228300, 6210227808, 6210226726, 6210225105, 6210224560, 6210223458, 6210222882, 6210221822, 6210221317, 8850008985, 8850008409, 8850007242, 8850006662, 8850004919, 8850003832, 8850003301, 8850002320, 8850001857, 8850000723, 8850000162, 6210220359, 6210219781, 6210218720, 6210218177, 6210217179, 6210216684, 6210209736, 6210209222, 6210208081, 6210207498, 6210206346, 6210205761, 6210204800, 6210204332, 6210203310, 6210203087, 6210201955, 62102",,"293 components","Blood products, collected from a donor who was permanently deferred, were distributed.",2/11/2010,"02/11/2010",4/3/2013,"04/03/2013"
"Biologics",54968,"Terminated","CSL Plasma, Inc.","Tucson","AZ","US","Voluntary: Firm Initiated","Other","Illinois.","B-2200-13","Class III","Source Plasma","6240116008, 6240114828, 6240114488, 6240113180, 6240112683, 6240112255, 6240111762, 6240111293, 6240104434, 6240103955, 6240103468, 6240102459, 6240102151, 6240101060, 6240100545, 6240100249, 6240096498, 6240096282, 6240095705, 6240095542, 6240094616, 6240094335, 6240171459, 6240170301, 6240169568, 6240168524, 6240167858, 6240159565, 6240157733, 6240242264, 6240235823, 6240235001, 6240233210, 6240232410, 6240230671, 6240229798, 6240227180, 6240226607, 6240224825, 6240224324, 6240222569, 6240221010, 6240219932, 6240218272, 6240217915, 6240215921, 6240215367, 6240212924, 6240211102, 6240210399, 6240208844, 6240208360, 6240206665, 6240205717, 6240204263, 6240203661, 6240202068, 6240201476",,"58 units","Blood products, collected from a donor who was deferred for specific high risk behavior, were distributed. ",10/2/2010,"10/02/2010",9/4/2013,"09/04/2013"
"Biologics",54972,"Terminated","CSL Plasma, Inc","Charleston","SC","US","Voluntary: Firm Initiated","FAX","NC, Germany & Switzerland","B-0695-13","Class III","Source Plasma","0440733325, 0440732998, 0440693444, 0440693223, 0440692465, 0440692173, 0440691045, 0440690318, 0440689983, 8800005470, 8800005133, 8800004264, 8800002762, 8800002466, 8800001697, 8800001179, 8800000460, 0440719469. 0440712328, 0440711835, 0440711180, 0440710859, 0440708974, 0440708243, 0440704527, 0440704223, 0440700965, 0440700666, 0440699862, 0440699651, 0440697278, 0440697057, 0440696346, 0440696117, 0440694297, 0440694063 ",,"36 units","Blood products, collected from a donor with a permanent deferral history, were distributed",11/20/2009,"11/20/2009",4/3/2013,"04/03/2013"
"Devices",55155,"Terminated","Alphatec Spine, Inc.","Carlsbad","CA","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution - USA including CO and NC; Internationally to Belgium.","Z-0967-2013","Class II","ILLICO Straight CP TI Rod, -5.5MM x 110M; REF#73601-110; Qty 1; LBL-005; REV.B; RX ONLY; Alphatec Spine, Inc. The ILLICO MIS Posterior Spinal Fixation System is intended to facilitate the surgical correction of non-cervical spinal deformities by providing temporary internal fixation and stabilization during bone graft healing and/or fusion mass development. ","Lot # 635436; Part #73601-110",".","7","The rods were incorrectly laser etched as ILLICO Straight CP Tl Rods, 110mm, when they were in fact manufactured to 100mm in length. ",7/6/2011,"07/06/2011",3/27/2013,"03/27/2013"
"Food",55288,"Ongoing","LL Bakery, Inc.","Torrance","CA","US","Voluntary: Firm Initiated","Letter","HI, WA, and CA","F-1474-2013","Class I","White Farm Enriched White Bread. 16 oz (454g), 9pc/box. UPC 0 10314 10002 0. The label is white with blue and green lettering and red design accents. The LL Bakery Logo is on the bottom left corner.","no lot codes",".","1020 units","LL Bakery Inc. of Torrance, CA is recalling all White Farm Enriched White Bread, Butter Farm Enriched White Bread, and Italian Cream Danish because product labels fail to declare the allergen milk, in the whey powder listed in their ingredient statements. ",5/18/2013,"05/18/2013",6/12/2013,"06/12/2013"
"Food",55288,"Ongoing","LL Bakery, Inc.","Torrance","CA","US","Voluntary: Firm Initiated","Letter","HI, WA, and CA","F-1476-2013","Class I","Italian Cream Danish 8.5 oz (240g), 14pc/box. UPC 0 10314 40056 4. The pastry is braided and has yellow creamy swirls and sliced almonds. The label is white with black lettering and a tan colored border. The LL Bakery Logo is on the bottom left corner.","Not available",".","1020 units","LL Bakery Inc. of Torrance, CA is recalling all White Farm Enriched White Bread, Butter Farm Enriched White Bread, and Italian Cream Danish because product labels fail to declare the allergen milk, in the whey powder listed in their ingredient statements. ",5/18/2013,"05/18/2013",6/12/2013,"06/12/2013"
"Food",55288,"Ongoing","LL Bakery, Inc.","Torrance","CA","US","Voluntary: Firm Initiated","Letter","HI, WA, and CA","F-1475-2013","Class I","Butter Farm Enriched White Bread 16 oz (454g), 9pc/box. UPC 0 10314 10004 4. The label is white with blue and green lettering and red design accents. The LL Bakery Logo is on the bottom left corner.","no lot codes",".","1020 units","LL Bakery Inc. of Torrance, CA is recalling all White Farm Enriched White Bread, Butter Farm Enriched White Bread, and Italian Cream Danish because product labels fail to declare the allergen milk, in the whey powder listed in their ingredient statements. ",5/18/2013,"05/18/2013",6/12/2013,"06/12/2013"
"Devices",55358,"Terminated","Karl Storz Endoscopy America Inc","El Segundo","CA","US","Voluntary: Firm Initiated","Letter","Distributed Nationwide and in Canada.","Z-1316-2013","Class II","Loop, Cutting, Angled 22FR (26055G/6). Resectoscope accessories (ie. electrode, cutting loops and cold knives).","Lot 36815",,"9432 units","Possible damage to the sterile packaging (blister tray) of some Karl Storz sterile products, which may result in airborne contamination.",6/1/2009,"06/01/2009",5/22/2013,"05/22/2013"
"Devices",55358,"Terminated","Karl Storz Endoscopy America Inc","El Segundo","CA","US","Voluntary: Firm Initiated","Letter","Distributed Nationwide and in Canada.","Z-1306-2013","Class II","Electrode, cutting, 24FR (27050G-.30/6). Resectoscope accessories (ie. electrode, cutting loops and cold knives).","Lot 36785, 36827",,"9432 units","Possible damage to the sterile packaging (blister tray) of some Karl Storz sterile products, which may result in airborne contamination.",6/1/2009,"06/01/2009",5/22/2013,"05/22/2013"
"Devices",55358,"Terminated","Karl Storz Endoscopy America Inc","El Segundo","CA","US","Voluntary: Firm Initiated","Letter","Distributed Nationwide and in Canada.","Z-1312-2013","Class II","Electrode, VaporCut, 24FR (27050SG/6). Resectoscope accessories (ie. electrode, cutting loops and cold knives).","Lot 36836",,"9432 units","Possible damage to the sterile packaging (blister tray) of some Karl Storz sterile products, which may result in airborne contamination.",6/1/2009,"06/01/2009",5/22/2013,"05/22/2013"
"Devices",55358,"Terminated","Karl Storz Endoscopy America Inc","El Segundo","CA","US","Voluntary: Firm Initiated","Letter","Distributed Nationwide and in Canada.","Z-1305-2013","Class II","Electrode, cutting, 24FR (27050G/6). Resectoscope accessories (ie. electrode, cutting loops and cold knives).","Lot 36775, 36786, 36828, 36864",,"9432 units","Possible damage to the sterile packaging (blister tray) of some Karl Storz sterile products, which may result in airborne contamination.",6/1/2009,"06/01/2009",5/22/2013,"05/22/2013"
"Devices",55358,"Terminated","Karl Storz Endoscopy America Inc","El Segundo","CA","US","Voluntary: Firm Initiated","Letter","Distributed Nationwide and in Canada.","Z-1310-2013","Class II","Electrode, Barrel Bar, 24FR (27050NX/6). Resectoscope accessories (ie. electrode, cutting loops and cold knives).","Lot 36850",,"9432 units","Possible damage to the sterile packaging (blister tray) of some Karl Storz sterile products, which may result in airborne contamination.",6/1/2009,"06/01/2009",5/22/2013,"05/22/2013"
"Devices",55358,"Terminated","Karl Storz Endoscopy America Inc","El Segundo","CA","US","Voluntary: Firm Initiated","Letter","Distributed Nationwide and in Canada.","Z-1309-2013","Class II","Electrode, Roller Ball, 24FR (27050NK/6). Resectoscope accessories (ie. electrode, cutting loops and cold knives).","Lot 36833",,"9432 units","Possible damage to the sterile packaging (blister tray) of some Karl Storz sterile products, which may result in airborne contamination.",6/1/2009,"06/01/2009",5/22/2013,"05/22/2013"
"Devices",55358,"Terminated","Karl Storz Endoscopy America Inc","El Segundo","CA","US","Voluntary: Firm Initiated","Letter","Distributed Nationwide and in Canada.","Z-1311-2013","Class II","Electrode, Roller, Vaporization, 24FR (27050RK/6). Resectoscope accessories (ie. electrode, cutting loops and cold knives).","Lot 36835",,"9432 units","Possible damage to the sterile packaging (blister tray) of some Karl Storz sterile products, which may result in airborne contamination.",6/1/2009,"06/01/2009",5/22/2013,"05/22/2013"
"Devices",55358,"Terminated","Karl Storz Endoscopy America Inc","El Segundo","CA","US","Voluntary: Firm Initiated","Letter","Distributed Nationwide and in Canada.","Z-1314-2013","Class II","Knife, Cold, Straight (27068K/6). Resectoscope accessories (ie. electrode, cutting loops and cold knives).","Lot 36851",,"9432 units","Possible damage to the sterile packaging (blister tray) of some Karl Storz sterile products, which may result in airborne contamination.",6/1/2009,"06/01/2009",5/22/2013,"05/22/2013"
"Devices",55358,"Terminated","Karl Storz Endoscopy America Inc","El Segundo","CA","US","Voluntary: Firm Initiated","Letter","Distributed Nationwide and in Canada.","Z-1315-2013","Class II","Electrode, Cutting, 24FR, 0.30MM (27040G-.30/6). Resectoscope accessories (ie. electrode, cutting loops and cold knives).","Lot 36897",,"9432 units","Possible damage to the sterile packaging (blister tray) of some Karl Storz sterile products, which may result in airborne contamination.",6/1/2009,"06/01/2009",5/22/2013,"05/22/2013"
"Devices",55358,"Terminated","Karl Storz Endoscopy America Inc","El Segundo","CA","US","Voluntary: Firm Initiated","Letter","Distributed Nationwide and in Canada.","Z-1307-2013","Class II","Electrode, Coag, Pointed, 24FR (27050L/6). Resectoscope accessories (ie. electrode, cutting loops and cold knives).","Lot 36829",,"9432 units","Possible damage to the sterile packaging (blister tray) of some Karl Storz sterile products, which may result in airborne contamination.",6/1/2009,"06/01/2009",5/22/2013,"05/22/2013"
"Devices",55358,"Terminated","Karl Storz Endoscopy America Inc","El Segundo","CA","US","Voluntary: Firm Initiated","Letter","Distributed Nationwide and in Canada.","Z-1313-2013","Class II","Loop, Cutting, 24FR (26050G/6). Resectoscope accessories (ie. electrode, cutting loops and cold knives).","Lot 36781",,"9432 units","Possible damage to the sterile packaging (blister tray) of some Karl Storz sterile products, which may result in airborne contamination.",6/1/2009,"06/01/2009",5/22/2013,"05/22/2013"
"Devices",55358,"Terminated","Karl Storz Endoscopy America Inc","El Segundo","CA","US","Voluntary: Firm Initiated","Letter","Distributed Nationwide and in Canada.","Z-1308-2013","Class II","Electrode, Coag, Ball End, 24FR (27050N/6). Resectoscope accessories (ie. electrode, cutting loops and cold knives).","Lot 36832",,"9432 units","Possible damage to the sterile packaging (blister tray) of some Karl Storz sterile products, which may result in airborne contamination.",6/1/2009,"06/01/2009",5/22/2013,"05/22/2013"
"Biologics",55398,"Terminated","Talecris Plasma Resources Inc","Research Triangle Park","NC","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","North Carolina, California","B-2338-13","Class II","Source Plasma","3800034441, 3800032963, 3800031721, 3800031117, 3800061119, 3800044099, 3800043574, 3800043308, 3800042701, 3800042446, 3800040166, 3800036611, 3800036056, 3800035601, 3800033829, 3800031619, 3800031056, 3800029495, 3800029052, 3800027611, 3800020879, 3800019437, 3800019060, 3800016421, 3800043103, 3800043401, 3800044883, 3800061156, 3800062351, 3800062037, 3800061087, 3800059037, 3800057791, 3800057431, 3800053183, 3800052751, 3800050597, 3800050012, 3800049533, 3800048851, 3800048498, 3800047437, 3800046967, 3800046487, 3800046099, 3800045624, 3800045148, 3800044755, 3800044108, 3800043854, 3800045464, 3800045197, 3800043716, 3800043469, 3800042777, 3800042379, 3800040938, 3800039861, 3800039302, 3800039125, 3800038663, 3800036000, 3800035570, 3800027847, 3800027414, 3800024053, 3800022990, 3800022385, 3800021146, 3800020606, 3800019512, 3800019141, 3800017656, 3800017293, 3800010836, 3800008946, 3800008555, 3800007831, 3800007681, 3800006840, 3800006539, 3800003680, 3800002834, 3800002431, 3800030154, 3800032873, 3800033291, 3800034272, 3800034599, 3800035890, 3800036577, 3800037440, 3800038021, 3800038445, 3800039186, 3800002804, 3800006511, 3800005605, 3800005329, 3800004480, 3800003643, 3800003226, 3800002580, 3800002116, 3800001828, 3800001415, 3800000921, 3800000762, 3800000375, 380122259, 380121932, 380109309, 3800047234, 3800046936, 3800046379, 3800046144, 3800045156, 3800044732, 3800043551, 3800043211, 3800042728, 3800042424, 3800041945, 3800040552, 3800040152, 3800039846, 3800039472, 3800003833, 3800002782, 3800002450, 3800000181, 3800037925, 3800037068, 3800036441, 3800028628, 3800027340, 3800027492, 3800026970, 3800022048, 3800020556, 3800002621, 3800002369, 3800001878, 3800001182, 3800000840, 3800000581, 3800000320, 3800000078, 380123172, 380122913, 380121788, 380121520, 380120749, 380120180, 380119392, 380113134, 380107776, 380087284, 380087226, 3800022446, 3800021085, 3800020581, 3800020066, 3800019303, 3800018664, 3800018291, 3800017541, 3800016596, 3800016255, 3800015706, 3800015272, 3800014"," 3800017592, 3800017199, 3800016540, 3800015732, 3800015344, 3800014673, 3800014281, 3800013651, 3800012065, 3800006542, 3800006286, 380123127, 380122858, 380122398, 380121633, 380121395, 3800021563, 3800012671, 3800010656, 3800010371, 3800009609, 3800006165, 3800004476, 3800004014, 3800001371, 3800012687, 3800012277, 3800011445, 3800011036, 3800009782, 3800009246, 3800008669, 3800008362, 3800006944, 3800005315, 3800004994, 3800003661, 3800003442, 3800002604, 3800001923, 3800001448, 3800001250, 3800000544, 3800000235, 380122917, 380122681, 380122180, 380121940, 380121401, 380121187, 380120605, 380120355, 380119821, 380114960, 380114753, 380114121, 380112950, 380112725, 380112239, 380111471, 380111188, 380109738, 380108937, 380107972, 380107426, 380106488, 380106187, 380105588, 380103262, 380100123, 380100111, 380122013, 380121151, 380120988, 380120322, 380119904, 380119437, 380119098, 380114428, 380114183, 380109649, 380108431, 380107360, 380092754, 380090689, 380089967, 380089266, 380088941, 3800002683, 380112242, 380111415, 380109719, 380108678, 380108485, 380106818, 380106481, 380103919, 380102051, 380101560, 380100677, 3800030048, 3800029729, 3800027361, 3800026531, 3800025915, 3800025416, 3800024151, 3800022926, 3800022512, 3800021762, 3800020722, 3800023982, 3800023611, 3800020062, 3800019681, 3800017053, 3800008906, 3800008477, 380109335, 380109316, 3800051907, 3800051289, 3800050136, 3800015029, 3800014652, 3800010212, 3800005689, 3800005406, 3800040391, 3800058420, 3800057962, 3800043430, 3800043779, 3800047902, 3800048302, 3800049424, 3800049712, 3800050448, 3800050733, 3800051436, 3800052397, 3800052801, 3800049949, 3800050558, 380085198, 380085487, 380086711, 380086172, 380092676, 380093728, 380094144, 380094719, 380095367, 380099339, 380099716, 380103457, 380107233, 380107514, 380108075, 380108349, 380111352, 380113843, 380119650, 380114097, 380113633, 380112473, 380112100, 380111712, 380109961, 380109548, 380107950, 380107460, 380106395, 380106054, 380105484, 380103475, 380103066, 380102463, 3801","7203 units","Blood products, collected from donors who did not have a complete physical examination, were distributed.",9/14/2009,"09/14/2009",9/4/2013,"09/04/2013"
"Biologics",55399,"Terminated","CSL Plasma, Inc.","Portland","OR","US","Voluntary: Firm Initiated","Other","Illinois, Switzerland, and Germany,","B-0635-13","Class II","Source Plasma","0550856093, 0550841218, 0550840504, 0550839338, 0550837885, 0550837160, 0550835759, 0550835036, 0550833139, 0550832421, 0550831206, 0550830373, 0550829181, 0550827968.",,"14 components","Blood products, collected from a donor with an incomplete health assessment, were distributed.",2/8/2010,"02/08/2010",3/6/2013,"03/06/2013"
"Biologics",55402,"Terminated","Octapharma Plasma Inc","Des Moines","IA","US","Voluntary: Firm Initiated","Letter","Switzerland","B-2300-13","Class II","Source Plasma","5250010874, 5250010311, 5250010319, 5250010332, 5250013674, 5250011148, 5250011158, 5250011547, 5250004906, 5250011379, 5250006860, 5250011267, 5250014217, 5250014231, 5250014243, 5250012599, 5250009582, 5250011738, 5250010341, 5250011825, 5250011786, 5250011956, 5250012050, 5250012107, 5250008037, 5250012123, 5250012160, 5250012173, 5250012239, 5250012305, 5250012307, 5250013184, 5250012247, 5250012194, 5250012196, 5250012394, 5250012351, 5250012456, 5250012471, 5250012687, 5250012522, 5250012552, 5250012556, 5250012577, 5250012518, 5250012549, 5250001560, 5250012397, 5250012692, 5250012489, 5250012497, 5250012371, 5250012357, 5250012383, 5250012446, 5250012353, 5250012683, 5250012885, 5250012701, 5250012872, 5250012859, 5250012860, 5250012762, 5250012794, 5250012808, 5250012826, 5250012731, 5250012809, 5250012944, 5250012953, 5250012942, 5250012836, 5250012838, 5250012847, 5250004109, 5250012795, 5250009400, 5250012805, 5250013040, 5250013147, 5250013148, 5250013167, 5250013150, 5250013153, 5250013085, 5250013138, 5250013061, 5250013077, 5250013031, 5250013175, 5250013116, 5250013120, 5250013134, 5250013113, 5250013159, 5250013087, 5250011354, 5250013279, 5250013021, 5250013434, 5250013264, 5250013216, 5250013219, 5250013243, 5250013226, 5250013369, 5250013401, 5250013416, 5250013501, 5250013459, 5250013471, 5250013481, 5250013482, 5250013636, 5250010865, 5250013534, 5250013505, 5250013519, 5250013565, 5250013607, 5250013528, 5250013581, 5250013714, 5250013641, 5250013667, 5250013702, 5250013707, 5250013754, 5250013765, 5250013791, 5250013797, 5250013822, 5250013825, 5250013896, 5250013899, 5250013880, 5250013921, 5250013804, 5250013918, 5250013799, 5250013872, 5250013884, 5250013857, 5250014063, 5250014082, 5250014088, 5250013988, 5250014099, 5250014080, 5250014253, 5250014197, 5250014180, 5250014191, 5250014194, 5250014356, 5250014262, 5250014271, 5250014280, 5250014274, 5250014277, 5250014303, 5250014340, 5250014492, 5250014391, 5250014443, 5250014455, 5250010360, 5250014462, 5250014475, 5250014418, 52500",,"1,881 units","Blood products, collected from donors who did not have a complete physical examination, were distributed.",12/18/2009,"12/18/2009",9/25/2013,"09/25/2013"
"Biologics",55443,"Terminated","Talecris Plasma Resources, Inc.","Research Triangle Park","NC","US","Voluntary: Firm Initiated","FAX","NC, CA","B-1496-13","Class II","Source Plasma","5090006622 5090007838 5090009528 5090009772 5090010217 5090011242 5090011570 5090012009 5090008618 5090008855 5090009091 5090009513 5090009779 5090010218 5090010474 5090010978 5090011293 5090012482 5090012720 5090013173 5090013432 5090013952 5090014202 5090014584 5090015372 5090015788 5090016130 5090016621 5090016942 5090017362 5090017732 5090018230 5090018539 5090018952 5090019410 5090020672 5090021261 5090023195 5090024312 5090024690 5090028952 5090029203 5090029522 5090029752 5090030021 5090030275 5090030869 5090031195 5090031574 5090031833 5090032264 5090013169 5090013606 5090013871 5090014301 5090014589 5090015902 5090016353 5090016715 5090006846 5090007264 5090007493 5090007827 5090009375 5090013709 5090013978 5090014438 5090014699 5090015114 5090015431 5090015890 5090016200 5090016665 5090016991 5090017502 5090017799 5090019124 5090019462 5090019984 5090020326 5090020817 5090021305 5090021644 5090022260 5090022661 5090023058 5090023437 5090023925 5090024284 5090024777 5090025110 5090025569 5090025989 5090026278 5090026537 5090026766 5090027016 5090027205 5090027348 5090027575 5090027869 5090028124 5090028437 5090028675 5090029008 5090029259 5090029573 5090029809 5090030085 5090030468 5090030676 5090030994 5090031229 5090031559 5090031769 5090007312 5090007497 5090012665 5090012835 5090013674 5090013835 5090014351 5090014542 5090015064 5090015406 5090016017 5090016299 5090016811 5090017090 5090017766 5090018778 5090019434 5090020291 5090020737 5090021254 5090021799 5090022110 5090022576 5090022878 5090023507 5090024248 5090024820 5090025339 5090013019 5090013786 5090014048 5090011638 5090011873 5090014760 5090006969 5090007142 5090007508 5090007718 5090008087 5090008298 5090008741 5090009001 5090009264 5090009531 5090009927 5090010243 5090011147 5090011424 5090011872 5090012176 5090012608 5090012856 5090013280 5090013600 5090013983 5090014738 5090015048 5090001036 5090001264 5090001371 5090001695 5090010371 5090010954 5090004799 5090006817 5090007931 5090002402 5090002634 5090003451 5090003663 5090009641"," 5090019866 5090023124 5090010498 5090010808 5090011234 5090011581 5090012008 5090012334 5090012848 5090013000 5090014425 5090015133 5090015433 5090024522 5090024875 5090012894 5090014327 5090014855 5090021362 5090023654 5090002327 5090002422 5090002592 5090002711 5090002922 5090003039 5090003230 5090003341 5090003687 5090003921 5090004046 5090004282 5090004410 5090004677 5090004822 5090005071 5090005227 5090005493 5090005661 5090005964 5090006142 5090006597 5090006929 5090007113 5090007489 5090007693 5090008446 5090008722 5090009368 5090009660 5090015275 5090015562 5090016039 5090016332 5090021642 5090001874 5090007617 5090008419 5090013002 5090013403 5090003950 5090004148 5090004385 5090004544 5090004794 5090004943 5090005194 5090005373 5090005727 5090006137 5090006359 5090006926 5090007206 5090007475 5090007732 5090007988 5090027959 5090028283 5090028523 5090028812 5090035194 5090008364 5090019888 5090009221 5090009366 5090009883 5090010308 5090010562 5090010963 5090011375 5090011845 5090012090 5090012545 5090012796 5090013251 5090013540 5090014527 5090014796 5090015253 5090015537 5090016010 5090016273 5090016828 5090017099 5090017605 5090017924 5090018477 5090018775 5090019282 5090019598 5090020121 5090020462 5090021076 5090021408 5090007592 5090007852 5090009532 5090010066 5090010619 5090010799 5090012142 5090012289 5090012873 5090013410 5090016501 5090016754 5090017289 5090007873 5090008116 5090008456 5090009173 5090009423 5090009804 5090010163 5090010962 5090011285 5090011721 5090012253 5090012494 5090012919 5090013347 5090013813 5090013975 5090017709 5090018223 5090018621 5090019202 5090019511 5090020049 5090020383 5090021653 5090022190 5090022747 5090023015 5090023553 5090023787 5090024343 5090024783 5090025226 5090025605 5090027115 5090027431 5090027660 5090027901 5090028239 5090028463 5090028791 5090029034 5090029372 5090032850 5090033093 5090033391 5090033738 5090033923 5090034239 5090034450 5090034782 5090035106 5090035295 5090035592 5090003898 5090004029 5090004265 5090004388 5090004668 509000486","8192","Blood products, collected from donors whose physical examinations were incomplete, were distributed.",11/3/2009,"11/03/2009",6/26/2013,"06/26/2013"
"Biologics",55584,"Terminated","BioLife Plasma Services L.P.","Great Falls","MT","US","Voluntary: Firm Initiated","FAX","CA","B-1529-13","Class II","Source Plasma","08GMTF0152, 08GMTF0785, 08GMTF3115, 08GMTF3717, 08GMTF4167, 08GMTF5308, 08GMTF5477, 08GMTF6333, 08GMTF7111, 08GMTF7230, 09GMTA0072, 09GMTA0203, 09GMTA1023, 09GMTA1171, 09GMTA2062, 09GMTA2185, 09GMTA3085, 09GMTA3242, 09GMTA4213, 09GMTA4385, 09GMTA5201, 09GMTA5577, 09GMTA6122, 09GMTA6475, 09GMTA6999, 09GMTA7336, 09GMTA7847, 09GMTA8158, 09GMTA8682, 09GMTA9013, 09GMTA9522, 09GMTA9881, 09GMTB0419, 09GMTB0761, 09GMTB1325, 09GMTB1856, 09GMTB2226, 09GMTB2766, 09GMTB3149, 09GMTB3666, 09GMTB4950, 09GMTB4800, 09GMTB5225, 09GMTB5675, 09GMTB6078, 09GMTB6638, 09GMTB7066, 09GMTB7641, 09GMTB8081, 09GMTB8908, 09GMTB9368, 09GMTB9998, 09GMTC0428, 09GMTC1053, 09GMTC1481, 09GMTC2610, 09GMTD1123, 09GMTD1517, 09GMTD2197, 09GMTD2583, 09GMTD3261, 09GMTD3745, 09GMTD4477, 09GMTD4893, 09GMTD5288, 09GMTD5796, 09GMTD6366, 09GMTD6843, 09GMTD7417, 09GMTD7821, 09GMTD8493, 09GMTD8887, 09GMTD9506, 09GMTD9908, 09GMTE0871, 09GMTE1679, 09GMTC2165. ",".","77 units","Blood products, collected from an unsuitable donor based on risk factors for variant Creutzfeldt-Jakob Disease (vCJD), were distributed.",2/17/2010,"02/17/2010",7/10/2013,"07/10/2013"
"Biologics",55593,"Terminated","Csl Plasma Inc","Tempe","AZ","US","Voluntary: Firm Initiated","Letter","Illinois, Germany, Switzerland.","B-2039-13","Class II","Source Plasma","0481339420 0481187078 0481187843 0481190303 0481193163 0481194078 0481196270 0481197223 0481199788 0481201648 0481203129 0481204842 0481206527 0481208049 0481209704 0481211349 0481215561 0481216908 0481222347 0481224106 0481225744 0481232998 0481234244 0481238148 0481238941 0481241888 0481243843 0481245817 0481247374 0481249476 0481252118 0481253347 0481255700 0481256776 0481259566 0481260471 0481263204 0481264353 0481269330 0481270059 0481275956 0481277763 0481281134 0481286536 0481287435 0481293164 0481294166 0481296600 0481297433 0481299805 0481300688 0481306049 0481306855 0481309181 0481310231 0481312385 0481313382 0481315586 0481316355 0481318776 0481319628 0481322889 0481323890 0481336417 0481338013",".","65 units","Blood products, collected from a donor considered to be at increased risk for variant Creutzfeldt-Jakob Disease (vCJD), were distributed. ",2/16/2010,"02/16/2010",9/11/2013,"09/11/2013"
"Biologics",55634,"Terminated","Hoxworth Blood Center University of Cincinnati Medical Center","Cincinnati","OH","US","Voluntary: Firm Initiated","Letter","Ohio.","B-2204-13","Class II","Red Blood Cells Leukocytes Reduced","W037708008520",,"1 unit","Blood products, which were collected from a donor who traveled to a malarial endemic area, were distributed.",2/5/2010,"02/05/2010",9/4/2013,"09/04/2013"
"Biologics",55636,"Terminated","American National Red Cross","Boise","ID","US","Voluntary: Firm Initiated","Telephone","NC, ID , UT ,OR, MT, WY, CA, AZ","B-1696-13","Class II","Red Blood Cells Leukocytes Reduced","020LE28771, 020LE28776, 020LE28796, 020LE28802, 020LE29112, 020LE29116, 020LE29155, 020LE29169, 020LE29183, 020LP96569, 020LP96576, 020LP96605, 020LQ28067, 020LQ28078, 020LQ28224, 020LQ28248, 020LQ28298.",".","17 units","Blood products, which were collected in a manner that may have compromised the sterility of the collection system, were distributed.",2/4/2010,"02/04/2010",7/17/2013,"07/17/2013"
"Biologics",55636,"Terminated","American National Red Cross","Boise","ID","US","Voluntary: Firm Initiated","Telephone","NC, ID , UT ,OR, MT, WY, CA, AZ","B-1697-13","Class II","Plasma Frozen within 24 hours (FP24)","020LE28771, 020LE28776 , 020LE28802 , 020LE29112 , 020LE29122, 020LE29126, 020LE29142, 020LQ28072, 020LQ28078, 020LQ28224, 020LQ28259. ",".","11 units","Blood products, which were collected in a manner that may have compromised the sterility of the collection system, were distributed.",2/4/2010,"02/04/2010",7/17/2013,"07/17/2013"
"Drugs",55714,"Completed","K C Pharmaceuticals Inc","Pomona","CA","US","Voluntary: Firm Initiated","E-Mail","Nationwide","D-192-2013","Class II","Eye Drops advanced relief (Dextran 70 0.1%, Polyethylene glycol 400 1%, Povidone 1%, Tetrahydrozoline HCl 0.05%) ophthalmic solution, 1/2 fl oz (15 mL) bottle, Distributed By Dolgencorp, LLC, 100 Mission Ridge, Goodlettsville, TN 37072.","Lot #: 9P367, Exp 12/12",,"31,704 bottles","Labeling: Label Mix-Up: Incorrect back labeling of the immediate container of eye drops (unit carton and front label are correct) which do not list three active ingredients: Dextran 70, PEG 400, and povidone. ",3/1/2010,"03/01/2010",3/20/2013,"03/20/2013"
"Biologics",55733,"Terminated","CSL Plasma Inc","Cleveland","OH","US","Voluntary: Firm Initiated","Other","IL.","B-2206-13","Class III","Source Plasma","4010524355, 4010518464, 4010517947, 4010516062, 4010514826, 4010507392, 4010506029, 4010504818, 4010503337, 4010501851, 4010499271, 4010497910, 4010495665, 4010494055, 4010491689, 4010490120, 4010488628, 4010487504, 4010485973, 4010482183, 4010481281, 4010479330, 4010478451, 4010474047, 4010471633, 4010469507, 4010468806, 4010465637, 4010464407, 4010461473, 4010460645, 4010458117, 4010453450, 4010451579, 4010447611, 4010447306, 4010444375, 4010443536, 4010441073, 4010411298, 4010409700, 4010408327, 4010406301, 4010402687, 4010401931, 4010399283, 4010398658, 4010396016, and 4010395462. ",,"49 units","Blood products, collected from a donor, whose suitability to donate were not adequately determined, were distributed.",3/15/2010,"03/15/2010",9/4/2013,"09/04/2013"
"Biologics",55743,"Terminated","BioLife Plasma Services L.P.","Elkhart","IN","US","Voluntary: Firm Initiated","E-Mail","CA, NY","B-2554-13","Class II","Source Plasma","09EINA0084, 09EINA0119, 09EINA0123, 09EINA0134, 09EINA0141, 09EINA0167, 09EINA0189, 09EINA0196, 09EINA0216, 09EINA0222, 09EINA0264, 09EINA0259, 09EINA0261, 09EINA0301, 09EINA0272, 09EINA0328, 09EINA0330, 09EINA0379, 09EINA0380, 09EINA0422, 09EINA0414, 09EINA0452, 09EINA0502, 09EINA0500, 09EINA0491, 09EINA0538, 09EINA0536, 09EINA0576, 09EINA0580, 09EINA0575, 09EINA0585, 09EINA0598, 09EINA0615, 09EINA0629, 09EINA0638, 09EINA0654, 09EINA0686, 09EINA0683, 09EINA0704, 09EINA0696, 09EINA0700, 09EINA0741, 09EINA0743, 09EINA0766, 09EINA0781, 09EINA0791, 09EINA0780, 09EINA0805, 09EINA0823, 09EINA0847, 09EINA0850, 09EINA0841, 09EINA0881, 09EINA0886, 09EINA0904, 09EINA0903, 09EINA0957, 09EINA0992, 09EINA0997, 09EINA0988, 09EINA0966, 09EINA1024, 09EINA0220, 09EINA0559, 09EINA1056, 09EINA0972, 09EINA1071, 09EINA1075, 09EINA1115, 09EINA1112, 09EINA1162, 09EINA1174, 09EINA1192, 09EINA1187, 09EINA1200, 09EINA1209, 09EINA1232, 09EINA1222, 09EINA1238, 09EINA1248, 09EINA1250, 09EINA1240, 09EINA1272, 09EINA1273, 09EINA1283, 09EINA1325, 09EINA1330, 09EINA1343, 09EINA1354, 09EINA1366, 09EINA1406, 09EINA1419, 09EINA1417, 09EINA1449, 09EINA1454, 09EINA1458, 09EINA1457, 09EINA1492, 09EINA1506, 09EINA1521, 09EINA1519, 09EINA1523, 09EINA1532, 09EINA1565, 09EINA1585, 09EINA1598, 09EINA1615, 09EINA1621, 09EINA1630, 09EINA1656, 09EINA1667, 09EINA1649, 09EINA1711, 09EINA1721, 09EINA1719, 09EINA1723, 09EINA1753, 09EINA1742, 09EINA1751, 09EINA1788, 09EINA1802, 09EINA1820, 09EINA1816, 09EINA1846, 09EINA1884, 09EINA1895, 09EINA1910, 09EINA1916, 09EINA1897, 09EINA1926, 09EINA1927, 09EINA1928, 09EINA1988, 09EINA1993, 09EINA1984, 09EINA1987, 09EINA2021, 09EINA2037, 09EINA2044, 09EINA2056, 09EINA2055, 09EINA2059, 09EINA2098, 09EINA2168, 09EINA2179, 09EINA2137, 09EINA2213, 09EINA2209, 09EINA2233, 09EINA2230, 09EINA2262, 09EINA2292, 09EINA2293, 09EINA2274, 09EINA2285, 09EINA2283, 09EINA2297, 09EINA2322, 09EINA2327, 09EINA2325, 09EINA2313, 09EINA2338, 09EINA2360, 09EINA2376, 09EINA2379, 09EINA2427, 09EINA2414, 09EINA2451, 09EINA2471, 09EINA2503, 09EIN"," 09EINC0955, 09EINC1018, 09EINC1157, 09EINC1187, 09EINC1183, 09EINC1172, 09EINC1236, 09EINC1209, 09EINC1214, 09EINC1217, 09EINC1234, 09EINC1243, 09EINC1258, 09EINC1287, 09EINC1321, 09EINC1319, 09EINC1300, 09EINC1306, 09EINC1318, 09EINC1383, 09EINC1403, 09EINC1385, 09EINC1423, 09EINC1441, 09EINC1432, 09EINC1415, 09EINC1421, 09EINC1427, 09EINC1483, 09EINC1497, 09EINC1520, 09EINC1533, 09EINC1543, 09EINC1512, 09EINC1528, 09EINC1562, 09EINC1607, 09EINC1611, 09EINC1636, 09EINC1620, 09EINC1621, 09EINC1671, 09EINC1669, 09EINC1661, 09EINC1695, 09EINC1692, 09EINC1719, 09EINC1740, 09EINC1725, 09EINC1771, 09EINC1757, 09EINC1775, 09EINC1785, 09EINB8649, 09EINC1831, 09EINC1849, 09EINC1860, 09EINC1867, 09EINC1858, 09EINC1898, 09EINC1910, 09EINC1888, 09EINC1914, 09EINC1936, 09EINC1932, 09EINC1976, 09EINC1989, 09EINC2009, 09EINC1982, 09EINC1991, 09EINC2000, 09EINC2037, 09EINC2022, 09EINC2061, 09EINC2073, 09EINC2080, 09EINC2092, 09EINC2095, 09EINC2120, 09EINC2108, 09EINC2134, 09EINC2155, 09EINC2171, 09EINC2153, 09EINC2165, 09EINC2191, 09EINC2218, 09EINC2183, 09EINC2192, 09EINC2248, 09EINC2225, 09EINC2263, 09EINC2260, 09EINC2258, 09EINC2289, 09EINC2299, 09EINC2309, 09EINC2350, 09EINC2334, 09EINC2347, 09EINC2318, 09EINC2366, 09EINC0707, 09EINC2342, 09EINC1059, 09EINC1903, 09EINC2445, 09EINC2433, 09EINC2489, 09EINC2484, 09EINC2521, 09EINC2504, 09EINC2499, 09EINC2530, 09EINC2540, 09EINC2537, 09EINC2539, 09EINC2549, 09EINC2573, 09EINC2578, 09EINC2584, 09EINC2580, 09EINC2613, 09EINC2616, 09EINC2645, 09EINC2646, 09EINC2649, 09EINC2651, 09EINC2697, 09EINC2683, 09EINC2679, 09EINC2695, 09EINC2680, 09EINC2716, 09EINC2721, 09EINC2710, 09EINC2709, 09EINC2711, 09EINC2739, 09EINC2747, 09EINC2749, 09EINC2769, 09EINC2802, 09EINC2821, 09EINC2837, 09EINC2851, 09EINC2831, 09EINC2863, 09EINC2901, 09EINC2930, 09EINC2922, 09EINC2951, 09EINC2961, 09EINC2991, 09EINC3025, 09EINC3016, 09EINC3013, 09EINC2998, 09EINC3111, 09EINC3131, 09EINC3139, 09EINC3134, 09EINC3170, 09EINC3159, 09EINC3160, 09EINC3182, 09EINC3235, 09EINC3243, 09EINC3239, 09EINC3266, 09EI","4927 units","Blood products, collected from donors who did not have a complete physical examination, were distributed.",4/30/2010,"04/30/2010",11/6/2013,"11/06/2013"
"Biologics",56007,"Terminated","American National Red Cross (The)","Salt Lake City","UT","US","Voluntary: Firm Initiated","Letter","CA, AZ, UT","B-0620-13","Class II","Cryoprecipitated AHF","006GQ64197","."," 1 unit","Blood products, collected in a manner that may have compromised the sterility of the collection system, were distributed.",4/23/2010,"04/23/2010",3/27/2013,"03/27/2013"
"Biologics",56007,"Terminated","American National Red Cross (The)","Salt Lake City","UT","US","Voluntary: Firm Initiated","Letter","CA, AZ, UT","B-0617-13","Class II","Red Blood Cells Leukocytes Reduced","006LH17884; 006GT77083; 006FE32665; 006GV77287; 006FY92834; 006GT76448; 006GX88821; 006FC59395; 006FC59400; 006FC59379; 006FC59396; 006FY93532; 006GE34211; 006LT85275; 006LP45417; 006FC61113; 006LP45394; 006LY83109; 006FE33850; 006LV50513; 006LV50490; 006LV50608; 006LQ04201; 006GX90106; 006GX90110; 006LT85283; 006FY93527; 006FY93530; 006FY93510; 006LY83107; 006LH17616; 006LV50512; 006lv50488; 006lv50506; 006FY93684; 006FY93514; 006LP45234; 006GE34215; 006GS40462; 006LY83121; 006LY83089; 006LY83117; 006FC60182; 006LY83118; 006GE34230; 006LQ04205; 006GQ64197; 006GT77323; 006LH17618; 006LH17613; 006LQ04192; 006GV79381; 006GV79390; 006GV79386; 006GV79380; 006GV79375; 006GV79378; 006GW55924; 006GW55916; 006FC61101; 006FC61109; 006FC61098; 006FC61114; 006FC61097; 006GW55822; 006GW55815; 006GW55826; 006LH17921; 006LH17890; 006LH17915; 006LH17909; 006LT85274; 006LV50499; 006LP45404; 006LP45423; 006FC61103; 006GW55931; 006LV50469; 006LP45246; 006FY93535; 006GS40395; 006GQ64213; 006LV50476; 006FE33000; 006LH17913; 006LY83125; 006LY88104; 006LQ04185; 006LP45285; 006LP45263; 006LP45421; 006LV50477; 006FE32997; 006FY93500; 006FY93507; 006FY93506",".","96 units","Blood products, collected in a manner that may have compromised the sterility of the collection system, were distributed.",4/23/2010,"04/23/2010",3/27/2013,"03/27/2013"
"Biologics",56007,"Terminated","American National Red Cross (The)","Salt Lake City","UT","US","Voluntary: Firm Initiated","Letter","CA, AZ, UT","B-0618-13","Class II","Cryoprecipitated AHF, Pooled","006L18545; 006L15866; 006L15054; 006L16546; 006L16578; 006L15055; 006L15867; 006L16869; 006L16558; 006L16863; 006L15843; 006L15842; 006L15092; 006L15039; 006L15071; 006L16707; 006L16551; 006L16589",".","18 units","Blood products, collected in a manner that may have compromised the sterility of the collection system, were distributed.",4/23/2010,"04/23/2010",3/27/2013,"03/27/2013"
"Biologics",56007,"Terminated","American National Red Cross (The)","Salt Lake City","UT","US","Voluntary: Firm Initiated","Letter","CA, AZ, UT","B-0616-13","Class II","Plasma Frozen within 24 Hours After Phlebotomy (FP24)","006fy93230; 006gv77545; 006ge03248; 006fc59791; 006fc59790; 003gx8824; 006gx88853; 006fe31590; 006fe31594; 006gx88583; 006fr07331; 006fr07309; 006fy91348; 006fy91374; 006gg04309; 006lt84124; 006gt77187; 006fc60206; 006gv77634; 006fy91381; 006fy91405; 006lh17613; 006lh17618; 006lt84157; 006fc61113; 006gw55907; 006fe32874; 006gp97396; 006fy92831; 006fc50784; 006fe33660; 006lh16752; 006gt76426; 006fy92836; 006fe31486; 006fy91545; 006fy91462; 006fy91430; 006fy91342; 006lt84151; 006gt77353; 006gt77080; 006gt77097; 006gt77085; 006fe32661; 006gv77524; 006gv77539; 006gv77529; 006lh16795; 006lh16791; 006lh16786; 006lt84133; 006ls18619; 006fc59802; 006fc59807; 006fy92261, 006lp43760; 006lp43758; 006lp43622; 006fy92095; 006gg04096; 006gp95751; 006ls18807; 006lt84139; 006lv50488; 008fe32991; 006fy91351; 006GT77321; 006FC60202; 006FC59927; 006FY91252; 006FC59932; 006LV50476; 006LP45404; 006LP45412; 006LP45423; 006LP45417; 006FE32979; 006FE32652; 006GX8832; 006GX88838; 006GX88834; 006FR07306; 006FY91320; 006FE3265; 006FC5339; 006GX8882; 006FY93198; 006FC59938; 006FY91356; 006LV50512; 006GW55916; 006LP45234; 006GE34230; 006FY93228; 006GT77327; 006FC60177; 006LT84391; 006FY92828; 006LT84147; 006LP43762; 006FR07279; 006FY913; 006GW55916; 006LP45234; 006GE34230; 006FY93228; 006GT77327; 006FC60177; 006LT84391; 006FY92828; 006LT84147; 006LP43762; 006FR07279; 006FY91552; 006FY91461; 006FY91461; 006GY91322; 006FE30810; 006LV50513; 006GP95732; 006GL03281; 006LT84131; 006GT76443; 006GT77323; 006FY91484; 006FY91440; 006FY91236;006GP95748; 006FY91394; 006FE30801; 006FE30814; 006FE30820; 006LV50504; 006LV50477; 006LH16787; 006FY92633; 006LT83833; 006FY92525; 006FR07294; 006GT76431; 006LV50490; 006LV50469; 006LV50506; 006GH30474; 006FY92074; 006FY91439; 006FE32858; 006FE32651; 006LH16799; 006GH30456; 006GH30427; 006FY91355; 006FY91247; 006GC72859; 006GP97371; 006FY91231; 006GX88558; 006FY91466; 006FY91511; 006FE32995; 006FH83893; 006GV77555; 006GV77637; 006GV77561; 006GV77548; 006GL03250; 006LT84387; 006GX88846; 006FY92069; 006GC72866;",".","180 units","Blood products, collected in a manner that may have compromised the sterility of the collection system, were distributed.",4/23/2010,"04/23/2010",3/27/2013,"03/27/2013"
"Biologics",56007,"Terminated","American National Red Cross (The)","Salt Lake City","UT","US","Voluntary: Firm Initiated","Letter","CA, AZ, UT","B-0621-13","Class II","Red Blood Cells Irradiated","006LV5047; 006LV5050; 006FE3299; 006FE3297; 006FE32995; ",".","5 units","Blood products, collected in a manner that may have compromised the sterility of the collection system, were distributed.",4/23/2010,"04/23/2010",3/27/2013,"03/27/2013"
"Biologics",56007,"Terminated","American National Red Cross (The)","Salt Lake City","UT","US","Voluntary: Firm Initiated","Letter","CA, AZ, UT","B-0619-13","Class II","Red Blood Cells (Apheresis) Leukocytes Reduced","006LP45217; 006LQ03498; 006LP45821; 006LS18807; 006GS40378; 006GQ64179; 006LP46627; 006LP46623; 006LP45625; 006GW55908; 006GS40379; 006GX900069; 006GW55918; 006GW55917; 006LQ03495; 006LQ03496; 006LP45623; 006LP45627; 006LP45625; 006GW55808; 006LT85266- PART 1; 006LT85266- PART 2; 006LP45217; 006GE34207- PART 1; 006GS40378; ",".","25 units","Blood products, collected in a manner that may have compromised the sterility of the collection system, were distributed.",4/23/2010,"04/23/2010",3/27/2013,"03/27/2013"
"Biologics",56007,"Terminated","American National Red Cross (The)","Salt Lake City","UT","US","Voluntary: Firm Initiated","Letter","CA, AZ, UT","B-0615-13","Class II","Fresh Frozen Plasma","06FE30808; 06FE30810; 06FE30814; 06FE30820; 06FY91231; 06FY91236; 06FY91247; 06FY91313; 06FY91320; 06FY91342; 06FY91348; 06FY91351; 06FY91355; 06FY91356; 06FY91374; 06FY91391; 06FY91394; 06FY91405",".","18 units","Blood products, collected in a manner that may have compromised the sterility of the collection system, were distributed.",4/23/2010,"04/23/2010",3/27/2013,"03/27/2013"
"Biologics",56177,"Terminated","Talercris Plasma Resources, Inc.","Research Triangle Park","NC","US","Voluntary: Firm Initiated","Letter","SC","B-2570-13","Class III","Source Plasma","359008792, 359015722, 359007620, 359013429, 359007845, 359009707, 359010056, 359010344, 359011161, 359004482, 359010329, 359010451, 359007735, 359008365, 359009515, 359009594, 359009709, 359010036, 359010608, 359007721, 359008310, 359010375, 359011676, 359004489, 359010079, 359010293, 359010388, 359013752, 359013161, 359007755. 359014070, 359015899, 359009149, 359014093, 359015177, 359009445, 359012320, 359012937, 359011380, 359007934, 359012905, 359010849, 359008546, 359008543, 359013638, 359013124, 359012468, 359012165, 359011618, 359011536, 359010712, 359009758, 359008634, 359007919, 359007646, 359015034, 359007479, 359012456, 359012072, 359014161, 359009310, 359009197, 359015382, 359015031, 359013606, 359012305, 359012142, 359010776, 359010573, 359010349, 359010043, 359009678, 359009527, 359007918, 359007851, 359014249, 359013544, 359013340, 359012604, 359009910, 359008227, 359008119, 359007563, 359015762, 359009290, 359007857, 359014169, 359013683, 359011376, 359009655, 359007626, 359011377, 359011096, 359010750, 359010658, 359010533, 359010448, 359015457, 359013549, 359011898, 359011381, 359010925, 359008573, 359012839, 359008977, 359013168, 359012309, 359008612, 359013618, 359012161 359010852, 359010037, 359009598, 359008160, 359009276, 359014243, 359013412, 359012840, 359011113, 359014625, 359013743, 359012083, 359011851, 359010393, 359010319, 359008033, 359007593, 359015847, 359014219, 359012983, 359012289, 359012181, 359015619, 359013601, 359009193, 359007684, 359011668, 359008604, 359008596, 359008791, 359015923, 359007628, 359016018, 359011665, 359010588, 359010153, 359009623, 359009524, 359007839, 359015929, 359015787, 359012975, 359012472, 359010898, 359012375, 349011956, 359011843, 359011583, 359011454, 359008336, 359008113, 359007974, 359008563, 359007720, 359013998, 359013675, 359013368, 359013170, 359009644, 359008159, 359015826, 359014586, 359016049, 359013990, 359012359, 359008644, 359010733, 359010503, 359010261, 359009619, 359008049, 359007910, 359013326, 359010815, 359015352, 359013125, ",,"875 units","Blood products, collected from a donor in which donor suitability was not adequately determined, were distributed.",3/1/2010,"03/01/2010",11/27/2013,"11/27/2013"
"Biologics",56197,"Terminated","Community Blood Center Of Gtr KC","Kansas City","MO","US","Voluntary: Firm Initiated","Letter","MO; KS; IL","B-1575-13","Class III","Red Blood Cells Leukocytes Reduced","W045009005846; W045009005849; W045009005855; W045009006140; W045009055966; W045009055994; W045009060785; W045009064974; W045009068435; W045009069882; W045009070592; W045009074872; W045009077325; W045009079051; W045009080374; W045009081796; W045009081796; W045009082500; W045009084700; W045009084708; W045009084878; W045009084880; W045009085097; W045009085097; W045009085694; W045009085881; W045009086095; W045009086662; W045009086662; W045009087089; W045009087238; W045009087846; W045009089462; W045009090898; W045009091113; W045009091309; W045009092210; W045009094625; W045009096808; W045009096869; W045009096871; W045009097845; W045009097995; W045009099542; W045009100893; W045009101833; W045009102557; W045009102568; W045009102764; W045009102823; W045009103442; W045009103444; W045009103445; W045009104453; W045009108732; W045009111096; W045009111100; W045009111447; W045009111542; W045009111949; W045009111969; W045009115093; W045009115475; W045009122559; W045009122563; W045009122974; W045009123069; W045009124084; W045009129978; W045009129983; W045010000261; W045010000264; W045010001369; W045010001915; W045010001915; W045010001985; W045010002995; W045010003314; W045010004049; W045010004325; W045010004346; W045010004537; W045010004930; W045010005064; W045010005235; W045010005770; W045010005795; W045010005885; W045010006153; W045010010483; W045010014563; W045010016561; W045010016668; W045010017981; W045010020241; W045010020244; W045010020321; W045010020790; W045010021005; W045010021205; W045010021675; W045010022905; W045010023749; W045010023826; W045010025015; W045010027716; W045010029688; W045010030344; W045010030415; W045010031076; W045010032479; W045010032481; W045010032589; W045010032859; W045010033666; W045010034479; W045010035118; W045010035243; W045010035436; W045010035608; W045010036037; W045010036319; W045010036349; W045010036790; W045010039499; W045010041000; W045010041234; W045010041452; W045010041890; W045010044402; W045010046501; W045010046504; W045010046630; W045010047534; W045010047832; W045010047867; W0450",".","147 Units","Blood products, which may have been exposed to unacceptable temperatures during storage, were distributed.",6/10/2010,"06/10/2010",7/17/2013,"07/17/2013"
"Devices",56447,"Ongoing","Technidata S.A.","Montbonnot St Martin",,"FR","Voluntary: Firm Initiated","Letter","Worldwide Distribution-USA (nationwide) including Washington DC and the states of California, Nevada, Kentucky, Alabama, Rhode Island, Pennsylvania, and Louisiana and the country of Italy.","Z-1345-2013","Class II","TD-Synergy. Laboratory Information System.","TD Lims product versions: LIS (ALLX)-21.041-_ML-5370, LIS (ALLX)-22.021-_ML-5374, TD-Synergy product versions: SYN (ALLX)- 03.13B-_ML-5368, SYN (ALLX)- 03.141-_ML-5369, SYN(LINUX)-06.011-_ML-5381, SYN (ALLX)-11.11B-_ML-5345, SYN (ALLX)-11.21B-_ML-5346 SYN (ALL)- 11.31C-_ML-5372, SYN (LINUX)-11.321-_FR-5382, SYN (ALL)-11.321-_ML-5373 ",".","10","Technidata has discovered that using the F8 key in the ERM session to add a combined test can result in the modification of the value of a result that has already been entered for a test of the request. ",7/29/2010,"07/29/2010",5/29/2013,"05/29/2013"
"Biologics",56466,"Completed","American National Red Cross (The)","Tulsa","OK","US","Voluntary: Firm Initiated","FAX","OK, CA, TX, IN","B-1308-13","Class II","Platelets Pheresis Leukocytes Reduced Irradiated","49KP13681, 49KP13684, 49KP13687 (2 units), 49KP13705 (2 units), 49KP13715 (2 units), 49KP13717 (3 units), 49KP13720, 49KP13724, 49KP13728, 49KP13735, 49KP13736, 49KP13738, 49KP13671",".","18 units","Blood products, which were labeled as leukoreduced, but were collected on an apheresis machine that failed quality control testing for leukoreduction, were distributed.",6/29/2010,"06/29/2010",5/1/2013,"05/01/2013"
"Biologics",56466,"Completed","American National Red Cross (The)","Tulsa","OK","US","Voluntary: Firm Initiated","FAX","OK, CA, TX, IN","B-1309-13","Class II","Platelets Pheresis Leukocytes Reduced","49KP13657 (2 units), 49KP13659, 49KP13661 (2 units), 49KP13663 (3 units), 49KP13666 (2 units), 49KP13669 (2 units), 49KP13671, 49KP13677, 49KP13681, 49KP13684 (2 units), 49KP13687, 49KP13691, 49KP13692, 49KP13695, 49KP13699, 49KP13708 (3 units), 49KP13704 (3 units), 49KP13713, 49KP13722, 49KP13724, 49KP13726, 49KP13728, 49KP13730, 49KP13732, 49KP13736 (2 units), 49KP13739 (2 units)",".","39 units","Blood products, which were labeled as leukoreduced, but were collected on an apheresis machine that failed quality control testing for leukoreduction, were distributed.",6/29/2010,"06/29/2010",5/1/2013,"05/01/2013"
"Biologics",56479,"Terminated","Talecris Plasma Resources, Inc.","Research Triangle Park","NC","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","NC","B-0301-13","Class III","Source Plasma","3960036260, 3960040395, 3960045419, 3960044791, 3960049126, 3960038309, 3960041518, 3960042604, 3960044381, 3960045946, 3960049362, 3960041668, 3960036528, 3960037383, 3960039345, 3960040984, 3960046561, 3960047630, 3960038635, 3960039269, 3960037127, 3960038858, 3960042900, 3960048564, 3960037839, 3960040945, 3960043000, 3960036786, 3960037820, 3960043349, 3960043948, 3960044834, 3960036398, 3960038024, 3960038438, 3960049641, 3960046652, 3960036766, 3960037199, 3960036246, 3960038727, 3960039751, 3960046557, 3960047168, 3960048574, 3960041287, 3960035846, 3960037530, 3960041029, 3960041529, 3960042520, 3960048748, 3960040882, 3960048088, 3960038704, 3960039209, 3960039132, 3960043247, 3960046343, 3960040957, 3960036795, 3960046690, 3960047822, 3960048229, 3960048016, 3960043208, 3960038207, 3960038817, 3960039478, 3960039839, 3960044368, 3960045996, 3960039230, 3960042516, 3960043563, 3960048652, 3960049172, 3960048237, 3960038729, 3960039044, 3960041088, 3960042104, 3960043206, 3960040371, 3960047916, 3960049402, 3960040124, 3960041779, 3960043161, 3960046220, 3960036695, 3960048310, 3960036017, 3960037050, 3960039042, 3960040085, 3960040718, 3960043135, 3960049163, 3960038158, 3960041166, 3960043249, 3960038300, 3960039363, 3960039358, 3960043694, 3960046521, 3960037131, 3960037657, 3960039186, 3960036240, 3960042874, 3960037096, 3960043815, 3960044337, 3960045634, 3960035655, 3960038822, 3960038549, 3960039822, 3960040428, 3960040548, 3960041023, 3960041688, 3960042726, 3960037849, 3960047692, 3960044851, 3960040355, 3960039942, 3960040810, 3960037790, 3960036830, 3960037494, 3960040527, 3960040631, 3960045772, 3960046192, 3960047675, 3960047339, 3960040297, 3960045482, 3960036191, 3960036780, 3960038795, 3960040431, 3960045591, 3960046667, 3960049120, 3960049455, 3960045541, 3960039029, 3960038867, 3960048833, 3960049470, 3960040956, 3960041983, 3960042480, 3960036045, 3960042149, 3960044233, 3960038012, 3960042637, 3960046030, 3960042652, 3960041375, 3960036848, 3960043788, 3960048104, 3960048401, 39600",".","628 units","Blood products, collected from donors for whom donor suitability was not adequately determined, were distributed.",3/22/2010,"03/22/2010",1/16/2013,"01/16/2013"
"Biologics",56582,"Terminated","Csl Plasma Inc","Chattanooga","TN","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Illinois, North Carolina, California, Germany, Switzerland","B-1399-13","Class III","Source Plasma","07 GDNBPZ, 07 GDSKNV, 07 GDSNJB, 07 GDSPMR, 07 GDSPYX, 07 GDJYGX, 07 GDJYNW, 4070342125, 4070329901, 4070329359, 4070027503, 4070025276, 4070024688, 07 GDWDKZ, 07GDRMTM, 07 GDRLZW, 4070007524, 4070007092, 4070000259, 07 GDVFNF, 07 GDRNXH, 07 GDRKVD, 07 GDRJZV, 07 GDRHTD, 07 GDPFTL, 07 GDNNNR, 07 GDNMXL, 07 GDLCHV, 07 GDLBYG, 07 CRYKNF, 07 CRXNHC, 07 CRXHMK, 07 CRXHCK, 07 CRXGFD, 07 CRXFNG, 07 CRXBPF, 07CRWZZP, 07 CRWNTF, 07 CRRFTX, 4070203800, 4070202955, 4070070885, 4070070136, 4070069698, 4070068917, 4070067519, 4070066918, 4070192972, 4070192186, 4070191328, 4070190659, 4070188959, 4070187779, 4070185953, 4070184320, 4070182771, 4070181929, 4070180972, 4070177519, 4070176464, 4070175984, 4070175075, 4070073132, 4070072783, 4070048291, 4070047820, 4070047264, 4070047021, 4070046564, 4070046280, 07 GDQXRS, 07 GDQWBR, 07 GDQTXX, 07 GDKCBH, 07 GDJZVZ, 07 GDJTNZ, 07 GDJTFJ, 07 GDJSRW, 07 GDDSBN, 07 GDDRTT, 07 GDDQFW, 07 GDDNQW, 07 GDDBTZ, 07 GDDBPD, 07 CRXXKB, 07 CRXYXZ, 07 CRXYKJ, 07 CRXWGD, 07CRXVXZ, 07 CRPZQW, 07 CRPYYX, 07 CRPYQV, 07 CRPXNG, 07 CRPXCW, 07 CRPVFQ, 07 CRPTVK, 07 CRYMLN, 07 CRYHXH, 07 CRWMRY, 07 CRWJVY, 07 CRWJKN, 07 CRWHMQ, 07 CRSXKL, 07 CRSWXR, 07 CRSWHT, 07 CRSVGR, 07 CRRDVL, 07 CRNZNC, 07 CRNXXZ, 07 CRLVRJ, 07 CRPFDC, 4070101194, 4070100488, 4070099697, 4070099207, 4070098529, 4070098072, 4070097359, 4070096889, 4070087737, 4070087113, 4070086320, 4070085713, 4070084993, 4070084376, 4070083704, 4070083198, 4070082538, 4070082035, 4070081244, 4070080942, 4070052824, 4070051694, 4070051124, 07 GDVLJR, 07 GDTFNG, 07 GDRJVB, 07 GDJWJR, 07 GDVFVS, 07 GDVDJP, 07 GDVBKY, 07GDTZLM, 07 GDRKWM, 07 GDJYPK, 07 GDJYHZ, 07 GDJXZF, 07 GDJXVV, 07 GDJXQD, 07 GDJXKT, 07 GDJXBJ, 07 GDJWMH, 07 GDFZMP, 07 GDFZFD, 07 GDFZBP, 07 GDFYRR, 07 GDFYKH, 07 GDFXZF, 07 GDFXLG, 07 GDFWTM, 07 CRSGMK, 07 CRSGGM, 07 CRSDSF, 07 CRSDNL, 07 CRSDLG, 07 CRSBSN, 07 CRSBDP, 07 CRSGDK, 07 CRSFXB, 07 CRSFSD, 07 CRSFFM, 07 CRRZQY, 07 CRRZLR, 07 CRQHNF, 07 CRQHGD, 07 CRQHDW, 07 CRQGLZ, 07 CRQGHF, 07 CRQGFG, 07 CRQFQG, 07 CRQFNP, 07 CRQ",".","236 units","Blood products, which were collected from a donor with a history of high risk behaviors, were distributed.",7/28/2010,"07/28/2010",6/19/2013,"06/19/2013"
"Biologics",56583,"Terminated","Talecris Plasma Resources, Inc.","Research Triangle Park","NC","US","Voluntary: Firm Initiated","FAX","NC","B-0751-13","Class II","Source Plasma","373106290, 373104952, 373102292, 373102227, 373104387, 373104046, 373103311, 373102963, 373102890, 3730023031, 3730022006, 3730021677, 3730020460, 3730019561, 3730019017, 3730017436, 3730016875, 3730015939, 3730015373, 3730014412, 3730013862, 3730012982, 3730012426, 3730011573, 3730011013, 3730010120, 3730009612, 3730008740, 3730008225, 3730007384, 3730006905, 3730006156, 3730005611, 3730004822, 3730004371, 3730003622, 3730003176, 3730002480, 3730002082, 3730001426, 3730001049, 3730000460, 3730000141, 373124259, 373123856, 373123171, 373122728, 373122071, 373121753, 373120437, 373119725, 373119289, 373118528, 373118110, 373117237, 373116718, 373115942, 373114631, 373114205, 373113359, 373112908, 373107951, 373107505, 373106615, 373106174, 373105287, 373104880, 373104009, 737103627, 373103027, 373101694, 373102022, 373102993, 373102011, 373102061, 373102917, 373102881, 373104906, 373104461, 373102159, 373102134, 3730011098, 3730010695, 3730009625, 3730009229, 3730008316, 3730007834, 3730006636, 3730005811, 3730005254, 3730003112, 3730002707, 373111764, 373102082, 373102052, 3730011236, 3730010676, 373102491, 373102441, 373111236, 373111188, 373106333, 373105876, 373105048, 373104628, 373101747, 373101259, 373102231, 373102195, 373102425, 373102400, 373102562, 373093909, 3730003030, 3730002351, 3730001907, 3730001315, 373102233, 373102194, 373111190, 373111144, 373102959, 373102915, 373111233, 373111172, 373093942, 373093918, 373108511, 373107513, 373107024, 373105722, 373105156, 373104528, 373103903, 373103442, 373099520, 373095841, 373093959, 373093934, 3730031628, 3730030607, 3730029153, 3730028670, 3730019103, 3730018765, 3730017614, 3730017021, 3730016213, 3730015501, 3730014521, 3730013896, 3730012710, 3730011672, 3730011360, 3730010371, 3730009690, 3730008801, 3730008248, 3730006278, 3730005903, 3730002614, 3730001787, 373111135, 373111089, 373102709, 373102629, 373116956, 373111223, 373111169, 373117398, 373102075, 373102060, 373111218, 373111157, 373110770, 373101475, 373100976, 373102708, 373102631, 37"," 3730014037, 3730013087, 3730012509, 3730011784, 3730011118, 3730010375, 3730009730, 3730008976, 3730008364, 3730007589, 3730006980, 3730005969, 3730005496, 3730004771, 3730004279, 3730003521, 3730003042, 3730002420, 3730001982, 3730001373, 3730000406, 3730000092, 373123098, 373122586, 373121946, 373121555, 373120840, 373120308, 373119580, 373118943, 373118458, 373117770, 373117289, 373116605, 373115986, 373114838, 373114063, 373113271, 373112691, 373111952, 373111526, 373110382, 373109554, 373108938, 373108171, 373106559, 3730001471, 3730001062, 3730000500, 3730000142, 373124321, 373123891, 373123207, 373122747, 373122108, 373121672, 373120927, 373120466, 373119719, 373119297, 373118583, 373118139, 373117430, 373116951, 373116148, 373115745, 373114416, 373114039, 373113141, 373112674, 373111906, 373111502, 373110285, 373109887, 373109129, 373108621, 373107609, 373106616, 373106245, 373102211, 373102184, 3730033737, 3730032387, 3730031112, 3730030574, 3730026512, 3730025885, 3730024963, 3730021745, 3730019884, 3730019268, 3730017610, 3730017114, 3730015903, 3730015259, 3730014403, 3730013819, 3730012675, 3730012116, 3730011306, 3730010681, 3730009811, 3730009259, 3730007007, 3730006623, 3730001400, 3730001038, 373124080, 373123636, 373122269, 373121823, 373120633, 373120151, 373119488, 373119001, 373117988, 373117670, 373106089, 373105636, 373104843, 373103551, 373103118, 373098410, 373097942, 373096530, 373102698, 373102625, 3730038237, 3730037726, 3730036769, 3730036242, 3730035205, 3730034717, 3730033666, 3730033189, 3730032276, 3730031767, 3730030726, 3730030263, 3730029274, 3730028787, 3730027782, 3730027299, 3730026393, 3730025899, 3730024781, 3730024202, 3730023096, 3730022599, 3730021642, 3730021007, 3730020048, 3730019580, 3730018502, 3730017990, 3730016969, 3730016445, 3730015452, 3730014955, 3730013936, 3730013484, 3730012516, 3730012039, 3730011132, 3730010659, 3730009743, 3730009261, 3730008322, 3730007847, 3730003261, 3730002869, 3730002148, 3730000185, 373123937, 373123608, 373122811, 373121717,","3124 units","Blood products, collected from donors who did not have a complete physical exam, were distributed.",7/13/2009,"07/13/2009",3/13/2013,"03/13/2013"
"Devices",56584,"Ongoing","Tosoh Bioscience Inc","Grove City","OH","US","Voluntary: Firm Initiated",,"Worldwide Distribution-USA (nationwide) including DC, Puerto Rico, Virgin Islands and the states of AK, AL, AR, AZ, CA, CO, CT, DE, FL, GA, IA, ID, IL, IN, KS, KY, LA, MA, MD, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NV, NY, OH, OK, OR, PA, PR, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI and WV, and the countries of Canada, Columbia, Chile, Brazil, and Jamaica.","Z-1075-2013","Class III","G7 HPLC. Used as an aid in the detection and presumptive identification of abnormal hemoglobins in whole blood. ","11103403, 11103503, 10942812, 11514801, 11674706, 11313707, 11273006, 10952212, 12266302, 10872910R, 12506812, 11273206, 12678203, 12728404, 12075007, 12205211, 12627811, 12668403, 12708704, 10361310R, 10792008R.",,"633","Inspectional observations made during establishment inspection include Quality System Regulation deficiencies found that several undocumented and unreported corrections were made to a device. These corrections may constitute changes to the device that may require the submission of a new 510(k).",8/18/2010,"08/18/2010",4/17/2013,"04/17/2013"
"Biologics",57059,"Terminated","HemaCare Corporation","Van Nuys","CA","US","Voluntary: Firm Initiated","Letter","CA","B-2182-13","Class II","Platelets Pheresis Leukocytes Reduced Irradiated","0750284A, 0750284B, 0751390C, 0752017B, W313710000679 (A), W313710000679(B), W313710000963 (C), W313710001522 (A), W313710001522 (B), W313710001522 (C), W313710001794 (A), W313710001794 (B), W313710001794 (C), W313710002071 (A), W313710002071 (B), W313710002071 (C). ",,"16 units ","Blood products, collected from a donor who traveled to a malarial endemic area, were distributed. ",9/20/2010,"09/20/2010",9/25/2013,"09/25/2013"
"Biologics",57059,"Terminated","HemaCare Corporation","Van Nuys","CA","US","Voluntary: Firm Initiated","Letter","CA","B-2181-13","Class II","Platelets Pheresis Leukocytes Reduced, Apheresis","0747488A ;0747488B ; 07474888C; ; 0748326A; 0748326B; 0748804A ; 0748804B; 0748804C; 0749147B; 0749451A; 0749451B; 749451C; 0749736A; 0749736B; 0749736C; 0749987A; 0749987B; 0749987C; 0750284C; 0750578A; 0750578B; 0750578C; 0750898A; 0750898B; 0750898C; 0752017A; 0752017B; 0752301A, 0752301C; W313710000269A, ; W313710000269B; W313710000269C; W313710000963A; W313710000963B; W313710001251A; W313710001251B; W313710001251C; 0751390A, 0751390B",,"39 units ","Blood products, collected from a donor who traveled to a malarial endemic area, were distributed. ",9/20/2010,"09/20/2010",9/25/2013,"09/25/2013"
"Biologics",57060,"Terminated","BioLife Plasma Services L.P.","Deerfield","IL","US","Voluntary: Firm Initiated","FAX","New York, Tennessee, California.","B-1632-13","Class II","Source Plasma","08MIDA5663, 08MIDA6675, 08MIDA6977, 08MIDA7108, 08MIDA7706, 08MIDA7941, 08MIDA8006, 08MIDA8391, 08MIDA8567, 08MIDA8822, 08MIDA9235, 08MIDA9269, 08MIDA9612, 08MIDA9796, 08MIDB0125, 08MIDB0231, 08MIDB0373, 08MIDB0613, 08MIDB1221, 08MIDB1409, 08MIDB1604, 08MIDB1606, 08MIDB1724, 08MIDB2310, 08MIDB2596, 08MIDB2702, 08MIDB3409, 08MIDB3773, 08MIDB4458, 08MIDB4459, 08MIDB4653, 08MIDB4821, 08MIDB5004, 08MIDB5426, 08MIDB5708, 08MIDB5764, 08MIDB6237, 08MIDB6472, 08MIDB6847, 08MIDB6996, 08MIDB7613, 08MIDB7999, 08MIDB8781, 08MIDB9151, 08MIDB9320, 08MIDB9800, 08MIDB9953, 08MIDB9978, 08MIDC0189, 08MIDC0332, 08MIDC0340, 08MIDC0592, 08MIDC1146, 08MIDC1550, 08MIDC1882, 08MIDC1998, 08MIDC2356, 08MIDC2363, 08MIDC2454, 08MIDC2784, 08MIDC3023, 08MIDC3176, 08MIDC3587, 08MIDC3843, 08MIDC4227, 08MIDC4658, 08MIDC5137, 08MIDC5143, 08MIDC5341, 08MIDC5527, 08MIDC5854, 08MIDC6651, 08MIDC7001, 08MIDC7098, 08MIDC7614, 08MIDC8167, 08MIDC8685, 08MIDC8700, 08MIDC9655, 08MIDD0084, 08MIDD0508, 08MIDD1808, 08MIDD3072, 08MIDD3187, 08MIDD3212, 08MIDD5784, 08MIDD7118, 08MIDD7390, 08MIDD7474, 08MIDD7483, 08MIDD8077, 08MIDD8594, 08MIDD9219, 08MIDD9222, 08MIDD9525, 08MIDD9858, 08MIDE0221, 08MIDE0713, 08MIDE1057, 08MIDE1376, 08MIDE1459, 08MIDE1730, 08MIDE2404, 08MIDE2712, 08MIDE3037, 08MIDE4058, 08MIDE4414, 08MIDE4437, 08MIDE4673, 08MIDE4808, 08MIDE4977, 08MIDE5260, 08MIDE5628, 08MIDE5801, 08MIDE6120, 08MIDE6174, 08MIDE6342, 08MIDE6818, 08MIDE6836, 08MIDE7452, 08MIDE7523, 08MIDE8177, 08MIDE8225, 08MIDE8293, 08MIDE8327, 08MIDE8602, 08MIDE8930, 08MIDE8948, 08MIDE8990, 08MIDE9020, 08MIDE9333, 08MIDE9546, 08MIDF0285, 08MIDF0479, 08MIDF0690, 08MIDF1142, 08MIDF1531, 08MIDF1564, 08MIDF1769, 08MIDF2142, 08MIDF2197, 08MIDF2393, 08MIDF2501, 08MIDF2519, 08MIDF2944, 08MIDF2986, 08MIDF3078, 08MIDF3182, 09MIDA0293, 09MIDA0302, 09MIDA0397, 09MIDA0841, 09MIDA0843, 09MIDA0866, 09MIDA1127, 09MIDA1136, 09MIDA1290, 09MIDA1386, 09MIDA1591, 09MIDA1694, 09MIDA1829, 09MIDA1889, 09MIDA1931, 09MIDA2810, 09MIDA2887, 09MIDA2967, 09MIDA3038, 09MIDA3086, 09MIDA3108, 09MIDA3143, 09MID",,"1007 units","Blood products, collected from a donor who received tattoos within 12 months of donation, were distributed",8/23/2010,"08/23/2010",7/3/2013,"07/03/2013"
"Biologics",57147,"Terminated","Tri-Counties Blood Bank","San Luis Obispo","CA","US","Voluntary: Firm Initiated","Letter","CA , Austria","B-1891-13","Class III","Red Blood Cells Leukocytes Reduced","W14281041940100E, W14281041940200C, W142810419404008, W142810419405006, W142810419406004, W142810419407002, W14281041940900Z, W14281041941000C, W14281041941100A, W142810419412008, W142810419413006, W142810419416000, W14281041941700Z, W14281041941800X, W14281041941900V, W142810419420008, W142810419421006, W142810419422004, W142810419423002, W14281041942500Z, W14281041942600X, W14281041942700V, W14281041942800T, W142810419430004, W142810419431002, W142810419432000, W14281041943300Z, W14281041943400X, W14281041943500V, W14281041943600T, W14281041943700R, W14281041943800P.",".","32 units","Blood products, which labels were applied to products with incorrect or missing information, were distributed. ",8/4/2010,"08/04/2010",8/14/2013,"08/14/2013"
"Biologics",57147,"Terminated","Tri-Counties Blood Bank","San Luis Obispo","CA","US","Voluntary: Firm Initiated","Letter","CA , Austria","B-1894-13","Class III","Red Blood Cells (Apheresis) Leukocytes Reduced","W14281041942900R, W142810419408000, W142810419415002.",".","3 units","Blood products, which labels were applied to products with incorrect or missing information, were distributed. ",8/4/2010,"08/04/2010",8/14/2013,"08/14/2013"
"Biologics",57147,"Terminated","Tri-Counties Blood Bank","San Luis Obispo","CA","US","Voluntary: Firm Initiated","Letter","CA , Austria","B-1893-13","Class III","Red Blood Cells Leukocytes Reduced Irradiated"," W142810419414004, W14281041940300A",".","2 units","Blood products, which labels were applied to products with incorrect or missing information, were distributed. ",8/4/2010,"08/04/2010",8/14/2013,"08/14/2013"
"Biologics",57147,"Terminated","Tri-Counties Blood Bank","San Luis Obispo","CA","US","Voluntary: Firm Initiated","Letter","CA , Austria","B-1892-13","Class III","Red Blood Cells (Apheresis) Leukocytes Reduced","W142810419408000, W142810419415002, W14281041942900R.",".","3 units","Blood products, which labels were applied to products with incorrect or missing information, were distributed. ",8/4/2010,"08/04/2010",8/14/2013,"08/14/2013"
"Biologics",57149,"Terminated","New York Blood Center, Inc.","New York","NY","US","Voluntary: Firm Initiated","Letter","France, UK, NY, NJ, CA","B-1338-13","Class II","Red Blood Cells Leukocytes Reduced","W047010307591; W047009246899; W047009231214; W047010170102; W047010246859",".","5 units","Blood products, collected from a donor who was previously deferred, were distributed.",9/29/2010,"09/29/2010",6/19/2013,"06/19/2013"
"Biologics",57149,"Terminated","New York Blood Center, Inc.","New York","NY","US","Voluntary: Firm Initiated","Letter","France, UK, NY, NJ, CA","B-1341-13","Class III","Blood and Blood Products for Reprocessing","W047009231214; W047009160659; W047008272554; W047010170102",".","4 units","Blood products, collected from a donor who was previously deferred, were distributed.",9/29/2010,"09/29/2010",6/19/2013,"06/19/2013"
"Biologics",57149,"Terminated","New York Blood Center, Inc.","New York","NY","US","Voluntary: Firm Initiated","Letter","France, UK, NY, NJ, CA","B-1342-13","Class II","Plasma Frozen within 24 hours (FP24)","W047010134887; W047009246899; W047010246859; W047010307591",".","4 units","Blood products, collected from a donor who was previously deferred, were distributed.",9/29/2010,"09/29/2010",6/19/2013,"06/19/2013"
"Biologics",57149,"Terminated","New York Blood Center, Inc.","New York","NY","US","Voluntary: Firm Initiated","Letter","France, UK, NY, NJ, CA","B-1339-13","Class II","Red Blood Cells","W047010134887; W047009160659; W047008272554; 5648436",".","4 units","Blood products, collected from a donor who was previously deferred, were distributed.",9/29/2010,"09/29/2010",6/19/2013,"06/19/2013"
"Biologics",57149,"Terminated","New York Blood Center, Inc.","New York","NY","US","Voluntary: Firm Initiated","Letter","France, UK, NY, NJ, CA","B-1340-13","Class II","Fresh Frozen Plasma","5648436",".","1 unit","Blood products, collected from a donor who was previously deferred, were distributed.",9/29/2010,"09/29/2010",6/19/2013,"06/19/2013"
"Biologics",57153,"Terminated","Talecris Plasma Resources, Inc.","Pueblo","CO","US","Voluntary: Firm Initiated","Letter","NC","B-1746-13","Class III","Source Plasma","3690046017, 3690047003, 3690057931, 3690070728, 3690069818, 3690071518, 3690075705, 3690082581, 3690084154, 3690084809, 3690086162, 3690086842, 3690087453, 3690088534, 3690089005, 3690090037, 3690122859, 3690110536, 3690113457, 3690117277, 3690069540, 3690076389, 3690077820, 3690079367, 3690082418, 3690084984, 3690085708, 3690086985, 3690087785, 3690094194, 3690095267, 3690097091, 3690101413, 3690101816, 3690110723, 3690110975, 3690116507, 3690121658, 3690122080, 3690127086, 3690129095, 3690085440, 3690087050, 3690087465, 3690088098, 3690089703, 3690084731, 3690085090, 3690095618, 3690071741, 3690073541, 3690075659, 3690084322, 3690097767, 3690060061, 3690004298, 3690006414, 3690007471, 3690009277, 3690010933, 3690012139, 3690030080, 3690053041, 3690065837, 3690090840, 3690091287, 3690092521, 3690094565, 3690097087, 3690097501, 3690104244, 3690111048, 3690086080, 3690087088, 3690089144, 3690089865, 3690090974, 3690094256, 3690097297, 3690107880, 3690087929, 3690097796, 3690115784, 3690026452, 3690034886, 3690038282, 3690094642, 3690066216, 3690068381, 3690065990, 3690068935, 3690069999, 3690066055, 3690074060, 3690011882, 3690015441, 3690058254, 3690067495, 3690104164, 3690105806, 3690118521, 3690090874, 3690096242, 3690105801, 3690110944, 3690111404, 3690114461, 3690063176, 3690069015, 3690097897, 3690115568, 3690116367, 3690117850, 3690069769, 3690076311, 3690082230, 3690090724, 3690092424, 3690093521, 3690108486, 3690110580, 3690034142, 3690045870, 3690050969, 3690094484, 3690095046, 3690072149, 3690075113, 3690076164, 3690058720, 3690115410, 3690082969, 3690057915, 3690062227, 3690068010, 3690107242, 3690071604, 3690083311, 3690084710, 3690087387, 3690091609, 3690110171, 3690072482, 3690088067, 3690088575, 3690113409, 3690011282, 3690080407, 3690081956, 3690086542, 3690087820, 3690067857, 3690068445, 3690069943, 3690069110, 3690078494, 3690087310, 3690087721, 3690083567, 3690084204, 3690084572, 3690088331, 3690089516, 3690092763, 3690095896, 3690096533, 3690097474, 3690097889, 3690108271, 3690113061, 36901"," 3690110182, 3690110437, 3690111196, 3690113100, 3690117900, 3690086712, 3690066913, 3690093548, 3690094191, 3690098273, 3690102959, 3690105320, 3690120162, 3690120690, 3690126199, 3690006003, 3690011749, 3690047763, 3690117842, 3690118217, 3690119453, 3690123171, 3690094165, 3690121979, 3690110336, 3690114666, 3690058921, 3690090082, 3690106527, 3690032175, 3690084061, 3690088261, 3690093669, 3690118145, 3690121449, 3690069935, 3690071629, 3690073639, 3690069998, 3690071897, 3690066315, 3690085981, 3690102072, 3690093160, 3690067598, 3690068148, 3690045049, 3690047621, 3690075488, 3690079503, 3690081069, 3690083055, 3690085421, 3690086070, 3690094198, 3690104404, 3690110340, 3690112249, 3690113252, 3690087830, 3690121795, 3690122355, 3690089875, 3690069630, 3690077897, 3690084944, 3690085360, 3690097774, 3690069008, 3690080726, 3690070416, 3690077388, 3690078422, 3690065288, 3690067770, 3690070325, 3690072247, 3690073120, 3690076040, 3690079288, 3690004011, 3690006708, 3690070505, 3690072473, 3690108996, 3690110424, 3690111090, 3690113733, 3690115423, 3690082805, 3690084264, 3690077645, 3690080225, 3690111752, 3690112752, 3690114631, 3690113426, 3690094583, 3690095893, 3690103460, 3690112061, 3690112759, 3690113228, 3690124360, 3690126062, 3690121916, 3690066820, 3690075548, 3690083971, 3690101560, 3690104145, 3690105105, 3690105671, 3690115108, 3690116425, 3690013526, 3690016848, 3690022648, 3690030116, 3690033598, 3690034580, 3690051189, 3690056720, 3690114424, 3690115532, 3690095938, 3690097259, 3690102170, 3690087101, 3690091430, 3690095602, 3690104221, 3690106190, 3690000973, 3690001724, 3690004422, 3690018542, 3690024430, 3690055613, 3690056876, 3690060950, 3690062226, 3690072730, 3690080206, 3690095786, 3690081845, 3690082801, 3690020034, 3690023378, 3690095364, 3690036941, 3690104635, 3690090750, 3690097543, 3690124232, 3690126329, 3690126811, 3690081954, 3690073217, 3690098238, 3690032891, 3690033588, 3690054053, 3690102474, 3690102910, 3690104447, 3690106839, 3690081766, 3690085395, 3690087120, 3690","8,861 units","Blood products, collected from a donor in which donor suitability was not adequately determined, were distributed.",1/10/2011,"01/10/2011",8/21/2013,"08/21/2013"
"Biologics",57154,"Terminated","Talecris Plasma Resources, Inc.","Research Triangle Park","NC","US","Voluntary: Firm Initiated","Other","North Carolina","B-0809-13","Class III","Source Plasma","3670025086, 3670025298, 3670025347, 3670025312, 3670025264, 3670025276, 3670025542, 3670025538, 3670025517, 3670025487, 3670025775, 3670025771, 3670025765, 3670026255, 3670026342, 3670026244, 3670026344, 3670026371, 3670026248, 3670026392, 3670026324, 3670026291, 3670027721, 3670028627, 3670028631, 3670028742, 3670028749, 3670028666, 3670028762, 3670028753, 3670029111, 3670029920, 3670033662, 3670034865, 3670037689, 3670037788, 3670037858, 3670037809, 3670037813, 3670038433, 3670038437, 3670038452, 3670039310, 3670039444, 3670039291, 3670039316, 3670039315, 3670039401, 3670039400, 3670039750, 3670041738, 3670041743, 3670042230, 3670042184, 3670042216, 3670042757, 3670042745, 3670042842, 3670042761, 3670042722, 3670042704, 3670042836, 3670042824, 3670042926, 3670043013, 3670043991, 3670043966, 3670044056, 3670044065, 3670043957, 3670044082, 3670044172, 3670044867, 3670044852, 3670044859, 3670045033, 3670045051, 3670045140, 3670045103, 3670045146, 3670045148, 3670045078, 3670045730, 3670045770, 3670045759, 3670045788, 3670045741, 3670045909, 3670045964, 3670045960, 3670046569, 3670046527, 3670046579, 3670049145, 3670051405, 3670051440, 3670051356, 3670051437, 3670051286, 3670051411, 3670051358, 3670051687, 3670051529, 3670051681, 3670051622, 3670051544, 3670051581, 3670051649, 3670051535, 3670052550, 3670052333, 3670052390, 3670052372, 3670052395, 3670052565, 3670052423, 3670052407, 3670052541, 3670052529, 3670052366, 3670052471, 3670052607, 3670052792, 3670052631, 3670052593, 3670052769, 3670052928, 3670052890, 3670052858, 3670052968, 3670052985, 3670052874, 3670052879, 3670052853, 3670052986, 3670052931, 3670052887, 3670052908, 3670053259, 3670053277, 3670055249, 3670055488, 3670055480, 3670055492, 3670055825, 3670055940, 3670055864, 3670055861, 3670055800, 3670055947, 3670056286, 3670056427, 3670056407, 3670056267, 3670056404, 3670056349, 3670056438, 3670056442, 3670056393, 3670056245, 3670056422, 3670056312, 3670056629, 3670056648, 3670056531, 3670056522, 3670056501, 3670056704, 3670056709, 3670056729, 36700",,"751 Components","Blood products, collected from donors, whose suitability to donate was not adequately determined, were distributed.",3/5/2010,"03/05/2010",4/3/2013,"04/03/2013"
"Biologics",57156,"Terminated","Plasma Biological Services Inc","Saint Joseph","MO","US","Voluntary: Firm Initiated","FAX","North Carolina","B-1260-13","Class II","Source Plasma","PQ071610; PQ071249; PQ070893; PQ070094; PQ069852; PQ069370; PQ069143; PQ068762; PQ068560; PQ068072; PQ067943; PQ066719; PQ066061; PQ065980; PQ065418; PQ065379; PQ064784; PQ064274; PQ063587; PQ061774; PQ060955; PQ060615; PQ060331; PQ059896; PQ059735; PQ057946; PQ057755; PQ057245; PQ057087; PQ056562; PQ056469",".","31 Units","Blood products, collected from a donor who was previously deferred for possibly exposure to vCJD, were distributed.",8/17/2010,"08/17/2010",6/5/2013,"06/05/2013"
"Biologics",57167,"Terminated","CSL Plasma, Inc.","Cleveland","OH","US","Voluntary: Firm Initiated","Other","IL.","B-2207-13","Class III","Source Plasma","4010349576;4010350620;4010347554;4010343601;4010342564;4010340320;4010338885;4010337382;4010335733;4010334286;4010331474;4010330072;4010328777;4010327410;4010325363;4010324357;4010306670;4010305812; 4010304113; 4010302270; 4010297706; 4010296811; 4010295138; 4010293950; 4010292781; 4010291645; 4010290249; 4010288987; 4010287618; 4010281923; 4010276581; 4010274380; 4010273818; 4010271959; and 4010271435.",,"35 units","Blood products, collected from a donor, whose suitability to donate were not adequately determined, were distributed.",9/13/2010,"09/13/2010",9/4/2013,"09/04/2013"
"Biologics",57168,"Terminated","CSL Plasma, Inc.","Portland","OR","US","Voluntary: Firm Initiated","Other","Illinois, Germany, and Switzerland.","B-0747-13","Class III","Source Plasma","05500078721, 0550884624, 0550880694, 0550878282, 0550877802, 0550876130, 0550874472, 0550872589, 0550869379, 0550866855, 0550866106, 0550865200, 0550864090, 0550862725, 0550862005, 0550860313, 0550859462, 0550857143, 0550856245, 0550855001, 0550854403, 0550852476, 0550850598, 0550850013, 0550848572, 0550848061, 0550846449, 0550844814, 0550843807, 0550842770, 0550840117, 0550838522, 0550837750, 0550836435, 0550834107, 0550832459, 0550829940, 0550828624, 0550827749, 0550826098, 0550825574, 0550823940, 0550823081, 0550821608, 0550819697, 0550819061.",,"46 components","Blood products, collected from a donor whose scheduled physical examination was incomplete, were distributed.",7/30/2010,"07/30/2010",3/13/2013,"03/13/2013"
"Biologics",57222,"Terminated","Delta Blood Bank","Stockton","CA","US","Voluntary: Firm Initiated","Telephone","CA.","B-1376-13","Class II","Red Blood Cells Leukocytes Reduced","W128710012578",".","1 unit","Blood product, collected from a donor based on travel to an area considered endemic for malaria, was distributed.",7/26/2010,"07/26/2010",6/19/2013,"06/19/2013"
"Biologics",57227,"Terminated","American Red Cross Blood Services","Saint Louis","MO","US","Voluntary: Firm Initiated","Letter","Missouri; Texas; Kentucky","B-1295-13","Class II","Red Blood Cells Leukocytes Reduced","011LS57368; 011LS57364; 011LS57327; 011LS57338 ",".","4 Units","Blood products, collected using equipment that had not been validated, were distributed. ",9/21/2010,"09/21/2010",6/5/2013,"06/05/2013"
"Biologics",57227,"Terminated","American Red Cross Blood Services","Saint Louis","MO","US","Voluntary: Firm Initiated","Letter","Missouri; Texas; Kentucky","B-1293-13","Class II","Platelets Pheresis Leukocytes Reduced Irradiated","011LS57296;011LS57296;011LS57303;011LS57311; 011LS57324;011LS57324;011LS57311;011LS57296; 011LS57354;011LS57354 ",".","10 Units","Blood products, collected using equipment that had not been validated, were distributed. ",9/21/2010,"09/21/2010",6/5/2013,"06/05/2013"
"Biologics",57227,"Terminated","American Red Cross Blood Services","Saint Louis","MO","US","Voluntary: Firm Initiated","Letter","Missouri; Texas; Kentucky","B-1294-13","Class II","Platelets Pheresis Leukocytes Reduced","011LS57298; 011LS57298; 011LS57298; 011LS57301; 011LS57301; 011LS57301; 011LS57303; 011LS57308; 011LS57311; 011LS57315; 011LS57315; 011LS57319; 011LS57324; 011LS57330; 011LS57349; 011LS57358; 011LS57358; 011LS57330; 011LS57324; 011LS57319; 011LS57354; 011LS57308; 011LS57349; 011LS57338; 011LS57363; 011LS57361; 011LS57330 ",".","27 Units","Blood products, collected using equipment that had not been validated, were distributed. ",9/21/2010,"09/21/2010",6/5/2013,"06/05/2013"
"Biologics",57229,"Terminated","Plasma Biological Services Inc","Columbia","MO","US","Voluntary: Firm Initiated","FAX","North Carolina","B-1258-13","Class II","Source Plasma","MQ086809; MQ086137; MQ085668; MQ084840; MQ084732; MQ083488; MQ082531; MQ081187; MQ080888; MQ079861; MQ079318; MQ077682; MQ076813; MQ075820; MQ075570; MQ074794; MQ074060; MQ073403; MQ073078; MQ072489; MQ072067; MQ071694; MQ071390; MQ071115; MQ070687; MQ070398; MQ070025; MQ069544; MQ069344",".","29 Units","Blood products, collected from a donor who was previously deferred after receiving a tattoo within a year of donating, were distributed. ",10/1/2010,"10/01/2010",6/5/2013,"06/05/2013"
"Biologics",57284,"Terminated","Biomat USA, Inc.","Los Angeles","CA","US","Voluntary: Firm Initiated","Letter","CA","B-0497-13","Class II","Source Plasma","0750007513 ;0750007843 ;0750008087 ;0750008301 ; 0750008547 ;0750000881 ; 0750009025 ;0750009484 ; 0750009742 ;0750010030 ;0750010314 ;0750010775 ; 0750011032 ;0750011312 ;0750011547 ;0750011877 ; 0750012029 ;0750012316 ;0750012601 ;0750012935 ; 0750013195 ;0750013556 ;0750013768 ;0750014035 ; 0750014273 ;0750014558 ;0750014804 ;0750015046 ; 0750021576 ;0750021705 ;0750022226 ;0750022421 ; 0750022825 ;0750023063 ;0750023388 ;0750023759 ; 0750024210 ;0750024500 ;0750024981 ;0750025221 ; 0750025577 ;0750026013 ;0750026548 ; 0750027012 ;0750027282 ;0750028041 ;0750028455 ; 0750028661 ;0750029157 ;0750029509 ;0750029982 ; 0750030304 ;0750030650 ;0750031601 ;0750032227 0750000010; 0750000072 ; 0750000121 ; 0750000232 ; 0750000319 ;0750000474;0750000547 ;0750000727 ; 0750000887 ;0750001012 ;0750001234 ;0750001493 ; 0750001693 ;0750001795 ;0750002091 ;0750002225 ; 0750002468 ;07500024601 ;0750002906 ;0750003104 ; 0750003318 ;0750003540 ;0750003839 ;0750004019 ; 0750004298 ;0750004489 ;0750004788 ;0750005077 ; 0750005322 ;0750005627 ;0750005850 ;0750006181 ; 0750006407; 075 0006736 ;0750007002 ;0750007335",".","91 ","Blood products, collected from a donor who was previously deferred, were distributed.",10/12/2010,"10/12/2010",2/6/2013,"02/06/2013"
"Biologics",57465,"Terminated","American National Red Cross (The)","Ashley","PA","US","Voluntary: Firm Initiated","FAX","PA, NY","B-1749-13","Class II","Red Blood Cells","30GV71814, 30FN33298, 30FW61951, 30FW62308, 30GZ19273",".","5 units","Blood products, collected from donors for whom donor suitability was not adequately determined, were distributed.",10/29/2010,"10/29/2010",7/24/2013,"07/24/2013"
"Biologics",57465,"Terminated","American National Red Cross (The)","Ashley","PA","US","Voluntary: Firm Initiated","FAX","PA, NY","B-1748-13","Class II","Red Blood Cells Leukocytes Reduced","30GV71292, 30GV71597, 30GX30904, 30GX32297, 30FN31824, 30FN31831, 30FN32575, 30FN34189, 30GT60367, 30GT60470, 30GT60478, 30GT60484, 30GV69491, 30GV69638, 30GX32685, 30GX32718, 30GX32738, 30GX32923, 30GX32957, 30GY87076, 30GY87106",".","21 units","Blood products, collected from donors for whom donor suitability was not adequately determined, were distributed.",10/29/2010,"10/29/2010",7/24/2013,"07/24/2013"
"Biologics",57465,"Terminated","American National Red Cross (The)","Ashley","PA","US","Voluntary: Firm Initiated","FAX","PA, NY","B-1750-13","Class II","Red Blood Cells (Apheresis) Leukocytes Reduced","30LM02557 (Parts 1 and 2)",".","2 units","Blood products, collected from donors for whom donor suitability was not adequately determined, were distributed.",10/29/2010,"10/29/2010",7/24/2013,"07/24/2013"
"Biologics",57786,"Terminated","American National Red Cross","Salt Lake City","UT","US","Voluntary: Firm Initiated","Telephone","Utah, Nevada, Washington DC, California, North Carolina and Pennsylvania","B-1019-13","Class III","Blood and Blood Products for Reprocessing","020LE34036, 020LE34040, 020LE34041, 020LE34043, 020LE34044, 020LE34045, 020LE34046, 020LE34048, 020LE34051, 020LE34053, 020LE34054, 020LE34055, 020LE34056, 020LE34059, 020LE34060, 020LE34061, 020LE34062, 020LE34063, 020LE34064, 020LE34065, 020LE34066, 020LE34067, 020LE34068, 020LE34069, 020LE34070, 020LE34071, 020LE34072, 020LE34073, 020LE34074, 020LE34075, 020LE34076, 020LE34077, 020LE34078, 020LE34079, 020LE34080, 020LE34081.",,"36 components","Blood products, possibly contaminated with air, were distributed.",11/9/2010,"11/09/2010",5/8/2013,"05/08/2013"
"Biologics",57786,"Terminated","American National Red Cross","Salt Lake City","UT","US","Voluntary: Firm Initiated","Telephone","Utah, Nevada, Washington DC, California, North Carolina and Pennsylvania","B-1020-13","Class II","Red Blood Cells Leukocytes Reduced","020LE34037 , 020LE34039 , 020LE34041 , 020LE34042 , 020LE34046, 020LE34047, 020LE34048, 020LE34049, 020LE34050, 020LE34051, 020LE34052, 020LE34054, 020LE34056, 020LE34057, 020LE34060, 020LE34061, 020LE34062, 020LE34063, 020LE34065, 020LE34066, 020LE34067, 020LE34068, 020LE34069, 020LE34070, 020LE34071, 020LE34072, 020LE34074, 020LE34076, 020LE34077, 020LE34078, ",,"30 components","Blood products, possibly contaminated with air, were distributed.",11/9/2010,"11/09/2010",5/8/2013,"05/08/2013"
"Biologics",57786,"Terminated","American National Red Cross","Salt Lake City","UT","US","Voluntary: Firm Initiated","Telephone","Utah, Nevada, Washington DC, California, North Carolina and Pennsylvania","B-1021-13","Class II","Plasma Frozen Within 24 Hours After Phlebotomy (FP24)","020LE34038, 020LE34049, 020LE34052, 020LE34057, 020LE34058. ",,"5 components","Blood products, possibly contaminated with air, were distributed.",11/9/2010,"11/09/2010",5/8/2013,"05/08/2013"
"Biologics",57787,"Terminated","Talecris Plasma Resources, Inc.","Research Triangle Park","NC","US","Voluntary: Firm Initiated","FAX","NC","B-0659-13","Class III","Source Plasma","3340071032; 3340070642; 3340044324; 3340081726; 3340081366; 3340080719; 3340080104; 3340086530; 3340086069; 3340084877; 3340083843; 3340092284; 3340090982; 3340090228; 3340088666; 3340088012; 3340087273; 3340082485; 3340070129, 3340069731, 3340067853, 3340067544 , 3340066891, 3340066603, 3340065983, 3340065723, 3340065086 , 3340064810, 3340064234, 3340063955, 3340063394, 3340063120, 3340062623 , 3340062177 , 3340061767, 3340061288, 3340060867, 3340058732 , 3340057797, 3340056897, 3340056423, 3340055934, 3340055465, 3340054968, 3340054612, 3340053991, 3340053539, 3340053011, 3340052581.",,"49 units","Blood products, collected from a donor, whose suitability to donate was not adequately determined, were distributed.",12/28/2010,"12/28/2010",4/3/2013,"04/03/2013"
"Biologics",57800,"Terminated","St. Thomas More Hospital Blood Bank","Canon City","CO","US","Voluntary: Firm Initiated","Telephone","CO","B-1860-13","Class III","Red Blood Cells Leukocytes Reduced","W337609001399, W337610001701",,"2 units","Blood products, collected from a donor with polycythemia, were distributed.",9/3/2010,"09/03/2010",8/7/2013,"08/07/2013"
"Biologics",57800,"Terminated","St. Thomas More Hospital Blood Bank","Canon City","CO","US","Voluntary: Firm Initiated","Telephone","CO","B-1861-13","Class III","Fresh Frozen Plasma","W337610001737, W337609001008, W337609001246, W337609001399, W337610001701, W337610001801 ",,"6 units","Blood products, collected from a donor with polycythemia, were distributed.",9/3/2010,"09/03/2010",8/7/2013,"08/07/2013"
"Food",57997,"Terminated","Ron's Pizza Warehouse","Miamisburg","OH","US","Voluntary: Firm Initiated","Visit","Statewide: distribution in OH.","F-1208-2013","Class II","The pizza dough shells come in 5 lb. brown cardboard boxes, containing 25 shells per box. ","None.",".","approximately 700 pizza shells","There is no labeling on the product, and the product contains the allergen, wheat.",2/11/2011,"02/11/2011",3/27/2013,"03/27/2013"
"Biologics",58193,"Terminated","American National Red Cross (The)","Pomona","CA","US","Voluntary: Firm Initiated","Letter","CA","B-2457-13","Class III","Platelets Pheresis Leukocytes Reduced","06KN54122; 06KN54125; 06KN54127; 06KN54130; 06KN54131; 06KN54134; 06KN54138; 06KN54140; 06KN54137; 06KN54141; 06KN54146; 06KN54121 06KN54122; 06KN54126; 06KN54127; 06KN54136; 06KN54137; 06KN54141 06KN54143; 06KN54147 ",,"20 units","Blood products, which may have been exposed to unacceptable storage temperatures, were distributed.",1/19/2011,"01/19/2011",11/27/2013,"11/27/2013"
"Biologics",58193,"Terminated","American National Red Cross (The)","Pomona","CA","US","Voluntary: Firm Initiated","Letter","CA","B-2456-13","Class III","Platelets Pheresis Leukocytes Reduced Irradiated","06KN54134; 06KN54138; 06KN54139; 06KN54140; 06KN54122; 06KN54125; 06KN54127; 06KN54130; 06KN54131; 06KN54134; 06KN54138; 06KN54140 ",,"12 units","Blood products, which may have been exposed to unacceptable storage temperatures, were distributed.",1/19/2011,"01/19/2011",11/27/2013,"11/27/2013"
"Biologics",58204,"Terminated","Biomat USA, Inc.","Los Angeles","CA","US","Voluntary: Firm Initiated","FAX","Spain, California.","B-0951-13","Class II","Source Plasma","0330236642; 0330228719; 0330229933; 0330230273; 0330230666; 0330230927; 0330231306; 0330231587; 0330232281; 0330233802; 0330234079; 0330247656; 0330247936; 0330248371; 0330248613; 0330249830; 0330250077; 0330228457; 0330250432; 0330250747; 0330251105; 0330251416; 0330251837; 0330252104; 0330252656; 0330253001; 0330253386; 0330253625; 0330254070; 0330254320; 0330254818; 0330255188. ",".","32 units","Blood products, collected from a donor who was in close contact with an individual diagnosed with viral hepatitis, were distributed. ",1/19/2011,"01/19/2011",4/24/2013,"04/24/2013"
"Biologics",58357,"Terminated","American National Red Cross (the)","Charlotte","NC","US","Voluntary: Firm Initiated","Telephone","NC","B-1714-13","Class II","Fresh Frozen Plasma","012LV66409, 012LV66410, 012LV66417, 012LV66418, 012LV66422, 012LV66425 ",".","6 units","Blood products, which were collected from a donor in which donor suitability was not adequately determined, were distributed.",1/27/2011,"01/27/2011",7/17/2013,"07/17/2013"
"Biologics",58357,"Terminated","American National Red Cross (the)","Charlotte","NC","US","Voluntary: Firm Initiated","Telephone","NC","B-1713-13","Class II","Red Blood Cells Leukocytes Reduced","012LV66398, 012LV66403, 012LV66405, 012LV66408, 012LV66409, 012LV66410, 012LV66413, 012LV66414, 012LV66417, 012LV66418, 012LV66419, 012LV66421, 012LV66422, 012LV66424, 012LV66425, 012LC66429",".","16 units","Blood products, which were collected from a donor in which donor suitability was not adequately determined, were distributed.",1/27/2011,"01/27/2011",7/17/2013,"07/17/2013"
"Biologics",58358,"Terminated","American National Red Cross (The)","Portland","OR","US","Voluntary: Firm Initiated","FAX","Oregon, Washington, Arizona, Virginia, and Alabama.","B-0714-13","Class II","Red Blood Cells (Apheresis) Leukocytes Reduced","021LQ59071; 021LQ59071; 021LQ59673; 021LQ59673; 021LQ59915; 021LQ59915; ",,"6 components","Blood products, which were collected from a donor who traveled to a malarial endemic area, were distributed.",1/27/2011,"01/27/2011",3/6/2013,"03/06/2013"
"Biologics",58358,"Terminated","American National Red Cross (The)","Portland","OR","US","Voluntary: Firm Initiated","FAX","Oregon, Washington, Arizona, Virginia, and Alabama.","B-0713-13","Class II","Red Blood Cells Leukocytes Reduced","021KS97435, 021KS97638, 021KS97647, 021KS97654, 021KS97722, 021KS97735, 021KS97737, 021KW88915, 021KW88933, 021KW88941, 021KW89609, 021KW89629, 021LH89688, 021LH89708, 021LH89774, 021LH89778, 021LH89787, 021LH89793, 021LK76002, 021LK76025, 021LL80496, 021LL80505, 021LL80557, 021LL80562, 021LL80931, 021LL81631, 021LS17820, 021LS17995, 021LS17996, 021LS18002, 021LS18022, 021LS18037, 021LS18046, 021LZ56619, 021LZ56651, 021LZ56661, ",,"36 components","Blood products, which were collected from a donor who traveled to a malarial endemic area, were distributed.",1/27/2011,"01/27/2011",3/6/2013,"03/06/2013"
"Biologics",58358,"Terminated","American National Red Cross (The)","Portland","OR","US","Voluntary: Firm Initiated","FAX","Oregon, Washington, Arizona, Virginia, and Alabama.","B-0715-13","Class II","Red Blood Cells Leukocytes Reduced Irradiated","021LK76013",,"1 component","Blood products, which were collected from a donor who traveled to a malarial endemic area, were distributed.",1/27/2011,"01/27/2011",3/6/2013,"03/06/2013"
"Biologics",58363,"Terminated","Talecris Plasma Resources, Inc","Research Triangle Park","NC","US","Voluntary: Firm Initiated","FAX","NC","B-0810-13","Class II","Source Plasma","3520106217, 3520105237, 3520104785, 3520104321, 3520103389, 3520103092, 3520102516, 3520102151, 3520101469, 3520101137, 3520100521, 3520100182, 3520099763, 3520099375, 3520098791, 3520098484, 3520097883, 3520097506, 3520096995, 3520096625, 3520096034, 3520095797, 3520095227, 3520094909, 3520094387, 3520094077, 3520093473, 3520093337, 3520092658, 3520092507, 3520091974, 3520091846, 3520091273, 3520091159",,"34 units","Blood products, collected from a donor whose scheduled physical examination was incomplete, were distributed.",3/9/2011,"03/09/2011",4/3/2013,"04/03/2013"
"Biologics",58427,"Terminated","Talecris Plasma Resources, Inc.","Research Triangle Park","NC","US","Voluntary: Firm Initiated","Letter","NC","B-0986-13","Class III","Source Plasma","3600120348, 3600121505, 3600129385, 3600129718, 3600139574, 3600146318, 3600113732, 3600117142, 3600126283, 3600152097, 3600119660, 3600124449, 3600116045, 3600120474, 3600132145, 3600102052, 3600095721, 3600105293, 3600112932, 3600132236, 3600148531, 3600120847, 3600122062, 3600112244, 3600155258, 3600119135, 3600121782, 3600125587, 3600120927, 3600122148, 3600117187, 3600155155, 3600097815, 3600153052, 3600138842, 3600136407, 3600094765, 3600091611, 3600095375, 3600111704, 3600113337, 3600138703, 3600142234, 3600097002, 3600102988, 3600106695, 3600118592, 3600128348, 3600130365, 3600131373, 3600135318, 3600145493, 3600146823, 3600149882, 3600150582, 3600151080, 3600152366, 3600156452, 3600117901, 3600091830, 3600092587, 3600100044, 3600101015, 3600116439, 3600120367, 3600103963, 3600092598, 3600097557, 3600125175, 3600136473, 3600097015, 3600125356, 3600116050, 3600116397, 3600118310, 3600138308, 3600095885, 3600117228, 3600136362, 3600138772, 3600141036, 3600146379, 3600103956, 3600105814, 3600120905, 3600125564, 3600092542, 3600095855, 3600102607, 3600108741, 3600111616, 3600112907, 3600119577, 3600145347, 3600106135, 3600106100, 3600134517, 3600136519, 3600136917, 3600138107, 3600138914, 3600141122, 3600142437, 3600143653, 3600148211, 3600101905, 3600144642, 3600102113, 3600102698, 3600107586, 3600108397, 3600111707, 3600117967, 3600120379, 3600126159, 3600150784, 3600132131, 3600115000, 3600119516, 3600120192, 3600127123, 3600129590, 3600130543, 3600097260, 3600110551, 3600149304, 3600155255, 3600156090, 3600115916, 3600125290, 3600129389, 3600130277, 3600095682, 3600097806, 3600125004, 3600102629, 3600108952, 3600118750, 3600100920, 3600106232, 3600135267, 3600136385, 3600141619, 3600142442, 3600098555, 3600101546, 3600138639, 3600097809, 3600099014, 3600108691, 3600122928, 3600124088, 3600125575, 3600128563, 3600130121, 3600132186, 3600139965, 3600141189, 3600095693, 3600095984, 3600106963, 3600125170, 3600125552, 3600129829, 3600133658, 3600141105, 3600140887, 3600092549, 3600095887, 3600098964, 36001",".","1116 units","Blood products, collected from a donor, whose suitability to donate were not adequately determined, were distributed.",3/28/2011,"03/28/2011",4/24/2013,"04/24/2013"
"Biologics",58605,"Terminated","Coffee Memorial Blood Center, Inc.","Amarillo","TX","US","Voluntary: Firm Initiated","Letter","TX","B-0415-13","Class II","Platelets Leukocytes Reduced","W067311002332A; W067311002638A; W067311002346A; W067311002603; W067311002663; W067311002665; W067311002723; W067311002327; W067311002326; W067311002329; W067311002722A; 067311002722B; W067311002545; W067311002332B;W067311002638A; W0673110026142A; W0673110026142B",".","17 components","Blood products, for which the sterility may have been compromised, were distributed.",4/16/2011,"04/16/2011",2/6/2013,"02/06/2013"
"Biologics",58605,"Terminated","Coffee Memorial Blood Center, Inc.","Amarillo","TX","US","Voluntary: Firm Initiated","Letter","TX","B-0416-13","Class II","Platelets Pheresis Leukocytes Reduced Irradiated","W067311002604; W067311002662; W067310026142A; W067310026142B; W067311002329; W067311002722; W067311002338",".","7 components","Blood products, for which the sterility may have been compromised, were distributed.",4/16/2011,"04/16/2011",2/6/2013,"02/06/2013"
"Biologics",58680,"Terminated","Plasma Biological Services","Asheville","NC","US","Voluntary: Firm Initiated","FAX","NC","B-0637-13","Class II","Source Plasma","AQ127299, AQ127044, AQ126535, AQ126248, AQ125780, AQ125488, AQ125001, AQ124734, AQ124452, AQ124190, AQ123836, AQ123592, AQ123299, AQ123099, AQ121609, AQ121437, AQ122999, AQ122800, AQ122357, AQ122177, AQ120700, AQ120518, AQ120089, AQ119847, AQ119412, AQ119174, AQ118720, AQ118548, AQ118133, AQ117865, AQ117303, AQ117035, AQ116499, AQ116305, AQ115865, AQ115663, AQ115241, AQ114875, AQ114657, AQ114225, AQ114058, AQ113693, AQ113481, AQ113182, AQ112979, AQ112578, AQ112351, AQ111961, AQ111781, AQ111445, AQ111237, AQ110882, AQ110649, AQ110308, AQ110096, AQ109672, AQ109498, AQ108918, AQ108557, AQ108262, AQ107942, AQ107742, AQ107373, AQ107106, AQ106812, AQ106520, AQ106321, AQ105992, AQ105636, AQ105224, AQ104971, AQ104693, AQ104514, AQ104204, AQ103961, AQ103674, AQ103449, AQ103194, AQ102985, AQ102708, AQ102486, AQ102174, AQ101814, AQ101168, AQ100806, AQ100690, AQ085468, AQ085211, AQ084888, AQ084672, AQ074311, AQ074134, AQ073725, AQ073565, AQ028245, AQ025877, AQ025243, AQ025074, AQ024728, AQ024419, AQ023985, AQ023894",,"102 units","Blood products, collected from a donor who was previously deferred, were distributed.",3/9/2011,"03/09/2011",3/6/2013,"03/06/2013"
"Biologics",58781,"Terminated","BioLife Plasma Services L.P.","Springfield","MO","US","Voluntary: Firm Initiated","E-Mail","CA","B-1530-13","Class III","Source Plasma","07FMOD4621; 07FMOD3544; 07FMOD2181; 07FMOD1338; 07FMOC0376; 07FMOB7154; 07FMOB5860; 07FMOB1859; 07FMOB1539; 07FMOB0637; 07FMOB0312; 07FMOA9472; 07FMOA8985; 07FMOA7595; 07FMOA7095; 07FMOA6600; 07FMOA2585; 07FMOB6257; 07FMOA1992; 07FMOA0725; 06FMOE5032",".","21 units","Blood products, collected from a donor with a history of brain surgery, were distributed.",5/5/2011,"05/05/2011",7/10/2013,"07/10/2013"
"Biologics",58782,"Terminated","Biotest Pharmaceuticals Corporation","Dickson City","PA","US","Voluntary: Firm Initiated","Telephone","PA","B-1698-13","Class II","Source Plasma","0090991017, 0090990692, 0090990207, 0090989917, 0090989427, 0090989110, 0090988619, 0090986626, 0090986135, 0090985782, 0090984487, 0090983458, 0090982937, 0090982638, 0090982076, 0090981765, 0090981181",".","17 units","Blood products, collected from a donor who did not have a physical examination, were distributed.",5/10/2011,"05/10/2011",7/24/2013,"07/24/2013"
"Biologics",58946,"Terminated","Talecris Plasma Resources, Inc.","Research Triangle Park","NC","US","Voluntary: Firm Initiated","FAX","NC","B-0412-13","Class III","Source Plasma","3630073785;3630073518;3630072890;3630072647;3630072205;3630071839;3630071293;3630071007;3630070559;3630070320;3630069898;3630069481;3630069198;3630068539;3630068130;3630067782;3630067388;3630067044;3630066659;3630066336;3630065972;3630065728;3630065190;3630065072;3630064636;3630064397;3630063950;3630063687;3630063267;3630062408;630062257;3630061843;3630061630;3630061193;3630060947;3630059940;3630058945;3630058778;3630056492;3630054774;3630054529;3630054303;3630053267;3630052995;3630052699;3630052510;3630049755;3630049615;3630049412;3630049164;3630049011;3630048782;3630048674;3630048440;3630048288;3630047925;3630047765;3630047517;3630047636;3630047017;3630046878",,"61 units","Blood products, which were collected from a donor in which donor suitability was not adequately determined, were distributed.",4/27/2011,"04/27/2011",3/20/2013,"03/20/2013"
"Drugs",59001,"Ongoing","A B Nutrition, Inc.","Spring","TX","US","Voluntary: Firm Initiated","E-Mail","In retail store located in TX and internet sales nationwide.","D-194-2013","Class II","PIRACETAM COGNITION ENHANCING AGENT Dietary Supplement PHARMACEUTICAL GRADE 800 mg 240 Capsules per bottle CTD Labs Houston, TX 77090 ","Lot #33250311 Exp. 04/13",,"2980 bottles","Marketed Without an Approved NDA/ANDA: The product is an unapproved new drug.",5/27/2011,"05/27/2011",3/20/2013,"03/20/2013"
"Drugs",59001,"Ongoing","A B Nutrition, Inc.","Spring","TX","US","Voluntary: Firm Initiated","E-Mail","In retail store located in TX and internet sales nationwide.","D-195-2013","Class II","PIRACETAM POWDER COGNITION ENHANCING AGENT Dietary Supplement CTD 500 grams PHARMACEUTICAL GRADECTD Labs Houston, TX 77090 ","Lot # 33280311 Exp. 03/13",,"509 bottles","Marketed Without an Approved NDA/ANDA: The product is an unapproved new drug.",5/27/2011,"05/27/2011",3/20/2013,"03/20/2013"
"Drugs",59001,"Ongoing","A B Nutrition, Inc.","Spring","TX","US","Voluntary: Firm Initiated","E-Mail","In retail store located in TX and internet sales nationwide.","D-196-2013","Class II","ANIRACETAM FAST ACTING NOOTROPIC Dietary Supplement PHARMACEUTICAL GRADE 750mg 60 Capsules per bottle CTD Labs Houston, TX 77090 ","Lot # 32000311 ",,"912 bottles","Marketed Without an Approved NDA/ANDA: The product is an unapproved new drug.",5/27/2011,"05/27/2011",3/20/2013,"03/20/2013"
"Biologics",59012,"Terminated","Blood Systems, Inc.","El Paso","TX","US","Voluntary: Firm Initiated","Letter","TX","B-1208-13","Class II","Red Blood Cells Leukocytes Reduced","W041110091473008, W04111009191000Z, W041110093299009, W041110093399001, W04111009340600Z, W04111008843300I, W04111008843400G, W04111008843700A, W04111008859500J, W04111008859600H, W04111009268800*, W04111009270700P, W04111010139200C, W041110101660004, W04111010194000P, W04111101618900R, W04111101712100E, W04111101782300S, W04111101872300K, W041111027386006, W04111102761400E, W04111102865200N, W041111030628008",".","23 units","Blood products, which did not meet the minimum requirement for volume, were distributed.",5/31/2011,"05/31/2011",5/1/2013,"05/01/2013"
"Biologics",59012,"Terminated","Blood Systems, Inc.","El Paso","TX","US","Voluntary: Firm Initiated","Letter","TX","B-1209-13","Class II","Red Blood Cells Leukocytes Reduced Irradiated","W04111009884300O, W041111016005001, W04111101796000A, W04111102009800N, W04111102860900T, W04111103060500M, W04111103061800C, W041111030637006",".","8 units","Blood products, which did not meet the minimum requirement for volume, were distributed.",5/31/2011,"05/31/2011",5/1/2013,"05/01/2013"
"Biologics",59131,"Terminated","BioLife Plasma Services L.P.","Fayetteville","AR","US","Voluntary: Firm Initiated","FAX","CA","B-0636-13","Class II","Source Plasma","10YARC6463; 10YARC6649; 10YARC7602; 10YARC7997; 10YARC8564; 10YARC8999; 10YARC9824; 10YARD0379; 10YARD0820; 10YARD1483; 10YARD2609; 10YARD2996; 10YARD3383; 10YARD3870; 10YARD4242; 10YARD4759; 10YARD5107; 10YARD5628; 10YARD1365; 10YARD1705; 10YARE1949; 10YARF0643; 10YARF1015; 11YARB3565; 11YARB4376; 10YARC9496; 10YARC9904; 10YARD0475; 10YARD0879; 10YARD1312; 10YARD1719; 10YARD2873; 10YARD3239; 10YARD3603; 10YARD4100; 10YARD4448; 10YARD4957; 10YARD5309; 10YARD5868; 10YARD6565; 10YARD6974; 10YARD7627; 10YARD7968; 10YARD8487; 10YARD9356; 10YARD9839; 10YARE0037; 10YARE0793; 10YARE1578; 10YARE2041; 10YARE2465; 10YARE2943; 10YARE3369; 10YARE4038; 10YARE4643; 10YARE4930; 10YARE5449; 10YARE6650; 10YARE7108; 10YARF0317; 11YARA0118; 11YARA0748; 11YARA1257; 11YARA2002; 11YARA2427; 11YARA2821; 11YARA3340; 11YARA3926; 11YARA4563; 11YARA4909; 11YARA5591; 11YARA6691; 11YARA7433; 10YARD7376; 10YARC7106; 10YARC8148; 10YARC9173; 10YARC9524; 10YARD0472; 10YARD3556; 10YARD4413; 10YARD4973; 10YARD8372; 10YARD9585; 10YARE3188; 10YARE6979; 10YARF0941; 11YARA9062; 11YARB0739; 11YARB1424; 10YARC9951; 10YARC9539; 10YARD0027; 10YARD1108; 10YARD1511; 10YARD2467; 10YARD5835; 10YARD6814; 10YARD7183; 10YARD8128; 10YARD8186; 10YARD9912; 10YARE0677; 10YARE4011; 10YARE4435; 11YARA0504; 10YARC9723; 10YARD1134; 10YARD1943; 10YARD5238; 10YARD5533; 10YARD6069; 10YARD6606; 10YARD8759; 10YARD9292; 10YARD9603; 10YARE0275; 10YARE0763; 10YARE1540; 10YARE1781; 10YARE2381; 10YARE2864; 10YARE3295; 10YARE4301; 10YARD1942; 10YARD2925; 10YARD3295; 10YARD3967; 10YARD4787; 10YARD5179; 10YARD5730; 10YARD6070; 10YARD6826; 10YARD9242; 10YARD9802; 10YARE0320; 10YARC6499; 10YARC6795; 10YARD1600; 10YARD1993; 10YARD2493; 10YARD2985; 10YARD3493; 10YARD3817; 10YARD4315; 10YARD4814; 10YARD5592; 10YARE2596; 10YARE3487; 10YARE4335; 10YARE5224; 10YARE6139; 10YARE6215; 11YARA0886; 11YARA1613; 11YARA2419; 11YARA2699; 11YARA3480; 11YARA3995; 11YARA4475; 11YARA4754; 11YARA5027; 11YARA5566; 11YARA5883; 11YARA6423; 11YARA6995; 11YARA7603; 11YARA8134; 11YARA8743; 11YARA9335; 11YAR",,"437 ","Blood products, collected from donors with incomplete physical examination, were distributed.",6/3/2011,"06/03/2011",3/6/2013,"03/06/2013"
"Biologics",59132,"Terminated","Community Blood Center of the Ozarks","Springfield","MO","US","Voluntary: Firm Initiated","FAX","MO; TX; AR; NC; TN; OH; MS;","B-1885-13","Class II","Red Blood Cells Leukocytes Reduced","W045110198384; W045111231311; W045111235643; W045110213388; W045110202176; W045110200571; W045110213387; W045111231336; W045111228340; W045111241714; W045110202805; W045110208558; W045110211561; W045110193447; W045110208176; W045110198517; W045110198671; W045110198484; W045110213121; W045110211930; W045110198834; W045110198841; W045110199767; W045110198553; W045110198519; W045110198666; W045110202815; W045110198445; W045110203531; W045110199174; W045110203569; W045110203557; W045110209301; W045110209333; W045110208572; W045110208591; W045110208563; W045110209870; W045110213140; W045110203742; W045110205970; W045110199773; W045110200191; W045110200227; W045110198504; W045110198571; W045110198637; W045110198383; W045110202822; W045110202829; W045110198451; W045110198483; W045110198472; W045110198473; W045110198464; W045110205948; W045110203050; W045110205954; W045110205939; W045110203523; W045110203604; W045110209337; W045110209331; W045110209156; W045110188078; W045110188079; W045110209903; W045110208175; W045110203685; W045110203711; W045110213108; W045110188237; W045110188235; W045110218004; W045110214486; W045110198711; W045110205874; W045110203061; W045110208562; W045110214184; W045110203603; W045110200226; W045110202178; W045110202200; W045110202164; W045110198622; W045110198381; W045110198461; W045110198481; W045110205886; W045110203590; W045110203564; W045110209299; W045110209170; W045110208601; W045110208631; W045110209760; W045110209940; W045110209915; W045110203708; W045110213169; W045110211935; W045110188230; W045110188218; W045110214225; W045110213775; W045110198614; W045110198713; W045110203563; W045110203591; W045110211604; W045110203734; W045110203730; W045110214447; W045110198369; W045110199203; W045110208181; W045110203694; W045110214228; W045110214441; W045110200142; W045110210750; W045110188221; W045110203585; W045110218019; W045110198567; W045110198608; W045110198626; W045110198707; W045110198456; W045110209154; W045110188231; W045110209305; W045110209864; W045110208179; W045110213137; W0451",".","670 Units","Blood products, collected in a manner that may have compromised the sterility of the collection system, were distributed.",4/18/2011,"04/18/2011",8/14/2013,"08/14/2013"
"Biologics",59132,"Terminated","Community Blood Center of the Ozarks","Springfield","MO","US","Voluntary: Firm Initiated","FAX","MO; TX; AR; NC; TN; OH; MS;","B-1888-13","Class II","Cryoprecipitated AHF ","W045110216936; W045110216976; W045110216972; W045110222052; W045110222044; W045111228051; W045111228062; W045110222050; W045110222062; W045110213116; W045110216287; W045110222033; W045110200227; W045110203577; W045110203564; W045110211561; W045110210939; W045110216275; W045110216748; W045110216915; W045111228060; W045111240917",".","22 Units","Blood products, collected in a manner that may have compromised the sterility of the collection system, were distributed.",4/18/2011,"04/18/2011",8/14/2013,"08/14/2013"
"Biologics",59132,"Terminated","Community Blood Center of the Ozarks","Springfield","MO","US","Voluntary: Firm Initiated","FAX","MO; TX; AR; NC; TN; OH; MS;","B-1884-13","Class II","Red Blood Cells Leukocytes Reduced Irradiated","W045110210942; W045110203566; W045111231320; W045110199254; W045110209874; W045110209932; W045110213116; W045110193473; W045110218893; W045110216742; W045110222062; W045111228903; W045111232508; W045111245749; W045111228354; W045111240957; W045111235642; W045111240428; W045110218213; W045111240860; W045111245139; W045110222102",".","22 Units","Blood products, collected in a manner that may have compromised the sterility of the collection system, were distributed.",4/18/2011,"04/18/2011",8/14/2013,"08/14/2013"
"Biologics",59132,"Terminated","Community Blood Center of the Ozarks","Springfield","MO","US","Voluntary: Firm Initiated","FAX","MO; TX; AR; NC; TN; OH; MS;","B-1886-13","Class II","Plasma Frozen within 24 hours ","W045110218862; W045110218228; W045110219150; W045110219133; W045110210656; W045111228041; W045111229352; W045111229346; W045111229357; W045111225190; W045111231079; W045111233272; W045111232665; W045110218231; W045110200646; W045110218881; W045110218871; W045110213441; W045111224033; W045111225176; W045111233944; W045111232672; W045111233256; W045110200597; W045110210605; W045111228038; W045111232153; W045111243753; W045111234996; W045111234965; W045110218220; W045110219117; W045110220269; W045110220275; W045110218888; W045110210954; W045110213390; W045110213380; W045110213399; W045111232147; W045111232146; W045111231101; W045111233997; W045111233034; W045111233048; W045111243759; W045111243767; W045110218217; W045110218885; W045110210950; W045110216721; W045110222097; W045110222102; W045111231077; W045111231132; W045111233774; W045111233277; W045111232692; W045111233253; W045111240428; W045110219137; W045110218884; W045110218893; W045110213393; W045110210615; W045110210666; W045110218970; W045111227286; W045110198849; W045110202805; W045110198475; W045110198484; W045110203117; W045110203137; W045110209903; W045110209834; W045110203727; W045110214447; W045110200142; W045110198483; W045110199767; W045110198364; W045110209301; W045110208591; W045110208631; W045110209864; W045110213775; W045110198504; W045110208572; W045110208563; W045110198834; W045110198859; W045110198513; W045110198614; W045110198713; W045110198639; W045110198637; W045110198711; W045110202815; W045110198473; W045110203604; W045110211604; W045110211608; W045110203730; W045110211930; W045110214470; W045110198595; W045110198517; W045110202813; W045110205954; W045110203039; W045110199181; W045110208558; W045110203664; W045110213145; W045110213174; W045110213140; W045110198293; W045110199773; W045110198567; W045110198553; W045110198381;W045110198369; W045110198451; W045110205970; W045110205886; W045110211917; W045110203746; W045110193495; W045110211938",".","130 Units","Blood products, collected in a manner that may have compromised the sterility of the collection system, were distributed.",4/18/2011,"04/18/2011",8/14/2013,"08/14/2013"
"Biologics",59132,"Terminated","Community Blood Center of the Ozarks","Springfield","MO","US","Voluntary: Firm Initiated","FAX","MO; TX; AR; NC; TN; OH; MS;","B-1887-13","Class II","Plasma Cryoprecipitate Reduced","W045110211561 ",".","1 Unit","Blood products, collected in a manner that may have compromised the sterility of the collection system, were distributed.",4/18/2011,"04/18/2011",8/14/2013,"08/14/2013"
"Biologics",59134,"Terminated","HemaCare Corporation","Van Nuys","CA","US","Voluntary: Firm Initiated","Letter","CA","B-2061-13","Class II","Red Blood Cells Leukocytes Reduced","W313711135113; W313711118495; W313711124899; W313711125072.",".","4 units","Blood products, collected from donors who reported travel to malarial endemic areas, were distributed.",6/1/2011,"06/01/2011",10/2/2013,"10/02/2013"
"Biologics",59134,"Terminated","HemaCare Corporation","Van Nuys","CA","US","Voluntary: Firm Initiated","Letter","CA","B-2059-13","Class II","Platelets Pheresis Leukocytes Reduced","W313711006151; W313711006151; W313711006151; W313711007011; W313711007011",".","5 units","Blood products, collected from donors who reported travel to malarial endemic areas, were distributed.",6/1/2011,"06/01/2011",10/2/2013,"10/02/2013"
"Biologics",59134,"Terminated","HemaCare Corporation","Van Nuys","CA","US","Voluntary: Firm Initiated","Letter","CA","B-2060-13","Class II","Platelets Pheresis Leukocytes Reduced Irradiated","W313711006529; W313711006529; W313711006529; W313711006773; W313711006773; W313711006773.",".","6 units","Blood products, collected from donors who reported travel to malarial endemic areas, were distributed.",6/1/2011,"06/01/2011",10/2/2013,"10/02/2013"
"Biologics",59219,"Terminated","United States Blood Bank, Inc.","Miami","FL","US","Voluntary: Firm Initiated","Telephone","Florida","B-1054-13","Class II","Red Blood Cells","W223211396557",".","1 unit","Blood product, which tested positive for anti-HBc, was distributed.",5/6/2011,"05/06/2011",5/1/2013,"05/01/2013"
"Biologics",59253,"Terminated","BioLife Plasma Services L.P.","Springfield","MO","US","Voluntary: Firm Initiated","E-Mail","NY, KY, CA","B-2465-13","Class II","Source Plasma","09FMOE9547, 09FMOE9637, 09FMOE9704, 09FMOE9733, 09FMOE9974, 09FMOF0004, 09FMOF0088, 09FMOF0307, 09FMOF0324, 09FMOF0345, 09FMOF0361, 09FMOF0411, 09FMOF0418, 09FMOF0439, 09FMOF0475, 09FMOF0501, 09FMOF0549, 09FMOF0762, 09FMOF0893, 09FMOF0905, 09FMOF0926, 09FMOF0959, 09FMOF0984, 09FMOF1130, 09FMOF1158, 09FMOF1161, 09FMOF1168, 09FMOF1169, 09FMOF1269, 09FMOF1277, 09FMOF1317, 09FMOF1471, 09FMOF1479, 09FMOF1611, 09FMOF1633, 09FMOF1643, 09FMOF1651, 09FMOF1750, 09FMOF1847, 09FMOF1848, 09FMOF1970, 09FMOF2107, 09FMOF2121, 09FMOF2133, 09FMOF2183, 09FMOF2184, 09FMOF2213, 09FMOF2267, 09FMOF2336, 09FMOF2364, 09FMOF2365, 09FMOF2401, 09FMOF2405, 09FMOF2435, 09FMOF2449, 09FMOF2450, 09FMOF2553, 09FMOF2669, 09FMOF2697, 09FMOF2859, 09FMOF2892, 09FMOF2931, 09FMOF2942, 09FMOF2988, 09FMOF3007, 09FMOF3248, 09FMOF3344, 09FMOF3391, 09FMOF3400, 09FMOF3406, 09FMOF3429, 09FMOF3725, 09FMOF3922, 09FMOF3929, 09FMOF3937, 09FMOF3965, 09FMOF4043, 09FMOF4136, 09FMOF4145, 09FMOF4186, 09FMOF4227, 09FMOF4228, 09FMOF4331, 09FMOF4421, 09FMOF4483, 09FMOF4527, 09FMOF4688, 09FMOF4706, 09FMOF4714, 09FMOF4736, 09FMOF4813, 09FMOF4843, 09FMOF4861, 09FMOF4891, 09FMOF4956, 09FMOF5006, 09FMOF5129, 09FMOF5159, 09FMOF5181, 09FMOF5188, 09FMOF5207, 09FMOF5395, 09FMOF5436, 09FMOF5476, 09FMOF5513, 09FMOF5517, 09FMOF5614, 09FMOF5679, 09FMOF5698, 09FMOF5718, 09FMOF5776, 09FMOF5876, 09FMOF5910, 09FMOF5912, 09FMOF5919, 09FMOF5944, 09FMOF5973, 09FMOF6049, 09FMOF6087, 09FMOF6132, 09FMOF6162, 09FMOF6290, 09FMOF6320, 09FMOF6323, 09FMOF6379, 09FMOF6394, 09FMOF6461, 09FMOF6481, 09FMOF6497, 09FMOF6542, 09FMOF6677, 09FMOF6710, 09FMOF6779, 09FMOF6801, 09FMOF6809, 09FMOF6832, 09FMOF6852, 09FMOF6862, 09FMOF6902, 09FMOF6921, 09FMOF6930, 09FMOF6953, 09FMOF6970, 09FMOF6988, 09FMOF7061, 09FMOF7062, 09FMOF7141, 09FMOF7142, 09FMOF7171, 09FMOF7186, 09FMOF7192, 09FMOF7244, 09FMOF7246, 09FMOF7404, 09FMOF7411, 09FMOF7417, 09FMOF7436, 09FMOF7474, 09FMOF7475, 09FMOF7511, 09FMOF7561, 09FMOF7562, 09FMOF7583, 09FMOF7595, 09FMOF7600, 09FMOF7645, 09FMOF7650, 09FMOF7703, 09FMOF7773, 09FMOF7799, 09FMO"," 10FMOB6934, 10FMOB6946, 10FMOB6954, 10FMOB6970, 10FMOB6972, 10FMOB6974, 10FMOB6984, 10FMOB6988, 10FMOB6992, 10FMOB7011, 10FMOB7042, 10FMOB7045, 10FMOB7100, 10FMOB7123, 10FMOB7128, 10FMOB7132, 10FMOB7151, 10FMOB7154, 10FMOB7179, 10FMOB7187, 10FMOB7194, 10FMOB7204, 10FMOB7219, 10FMOB7236, 10FMOB7244, 10FMOB7251, 10FMOB7254, 10FMOB7256, 10FMOB7263, 10FMOB7302, 10FMOB7331, 10FMOB7333, 10FMOB7336, 10FMOB7340, 10FMOB7342, 10FMOB7350, 10FMOB7352, 10FMOB7359, 10FMOB7396, 10FMOB7403, 10FMOB7406, 10FMOB7438, 10FMOB7469, 10FMOB7470, 10FMOB7491, 10FMOB7495, 10FMOB7501, 10FMOB7503, 10FMOB7519, 10FMOB7520, 10FMOB7522, 10FMOB7539, 10FMOB7553, 10FMOB7574, 10FMOB7590, 10FMOB7615, 10FMOB7631, 10FMOB7640, 10FMOB7644, 10FMOB7652, 10FMOB7719, 10FMOB7740, 10FMOB7741, 10FMOB7748, 10FMOB7753, 10FMOB7755, 10FMOB7801, 10FMOB7806, 10FMOB7807, 10FMOB7831, 10FMOB7861, 10FMOB7873, 10FMOB7882, 10FMOB7885, 10FMOB7892, 10FMOB7894, 10FMOB7897, 10FMOB7902, 10FMOB7912, 10FMOB7914, 10FMOB7918, 10FMOB7932, 10FMOB7941, 10FMOB7944, 10FMOB7947, 10FMOB7957, 10FMOB7976, 10FMOB7980, 10FMOB7996, 10FMOB7997, 10FMOB8008, 10FMOB8019, 10FMOB8061, 10FMOB8070, 10FMOB8071, 10FMOB8120, 10FMOB8130, 10FMOB8142, 10FMOB8156, 10FMOB8164, 10FMOB8193, 10FMOB8194, 10FMOB8197, 10FMOB8238, 10FMOB8243, 10FMOB8259, 10FMOB8262, 10FMOB8266, 10FMOB8289, 10FMOB8300, 10FMOB8304, 10FMOB8309, 10FMOB8319, 10FMOB8323, 10FMOB8336, 10FMOB8339, 10FMOB8341, 10FMOB8357, 10FMOB8374, 10FMOB8377, 10FMOB8418, 10FMOB8420, 10FMOB8449, 10FMOB8457, 10FMOB8462, 10FMOB8464, 10FMOB8466, 10FMOB8467, 10FMOB8471, 10FMOB8472, 10FMOB8476, 10FMOB8485, 10FMOB8497, 10FMOB8527, 10FMOB8541, 10FMOB8549, 10FMOB8574, 10FMOB8583, 10FMOB8605, 10FMOB8607, 10FMOB8610, 10FMOB8622, 10FMOB8623, 10FMOB8655, 10FMOB8662, 10FMOB8665, 10FMOB8684, 10FMOB8689, 10FMOB8700, 10FMOB8701, 10FMOB8728, 10FMOB8742, 10FMOB8751, 10FMOB8754, 10FMOB8761, 10FMOB8765, 10FMOB8793, 10FMOB8825, 10FMOB8845, 10FMOB8850, 10FMOB8879, 10FMOB8881, 10FMOB8883, 10FMOB8886, 10FMOB8888, 10FMOB8890, 10FMOB8904, 10FMOB8924, 10FMOB8928, 10FMOB8929, 10FM","5282 units","Blood products, collected from donors who may not have had a complete physical examination, were distributed.",6/10/2011,"06/10/2011",11/6/2013,"11/06/2013"
"Biologics",59257,"Terminated","CSL Plasma Inc","Lawrence","KS","US","Voluntary: Firm Initiated","Other","Illinois; Switzerland; Germany","B-0094-13","Class II","Source Plasma","01200637010; 01200470088; 01200176954; 01200174238; 01200166481; 01200163985; 01200156646; 01200153947; 01200147109; 01200143335; 01200137410; 01200134527; 01200127087; 01200125153; 01200117030; 01200114577; 01200105400; 01200102197; 01200094140",".","19 Units","Blood products, collected from donor's who did not have a complete physical examination, were distributed.",5/12/2011,"05/12/2011",1/30/2013,"01/30/2013"
"Biologics",59336,"Terminated","Biotest Pharmaceuticals Corporation","San Antonio","TX","US","Voluntary: Firm Initiated","FAX","CA","B-1502-13","Class II","Source Plasma","06519049; 06511074; 06503017; 06496197; 06482039; 06461867",,"6 units","Blood products, which were not quarantined subsequent to receiving disqualifying post donation information, were distributed.",5/20/2011,"05/20/2011",6/26/2013,"06/26/2013"
"Biologics",59414,"Terminated","Talecris Plasma Resources, Inc.","Research Triangle Park","NC","US","Voluntary: Firm Initiated","FAX","North Carolina","B-1561-13","Class III","Source Plasma","3960123216; 39601223330 ; 3960121814; 3960121011; 3960120309; 3960119657; 3960118638; 3960118139; 3960117309; 3960116824; 3960116024; 3960115424; 3960114675; 3960114100; 3960113325; 3960112818; 3960111726; 3960111298; 3960110490; 3960110001; 3960109024; 3960108623 3960107840 ; 3960107405 3960106731; 3960106364; 3960105290; 3960104517; 3960103998 3960102975;3960102538;3960101812;3960101424;3960100773;3960100260;3960098952;3960098445;3960097648;3960097126;3960096356;3960095962;3960095108;3960094706;3960093927;3960093398;3960092616;3960092134;3960091377;3960090872;3960090173;3960089676;3960088833;3960088441;3960087651;3960087225;3960080644;3960080277;3960079574;3960079152;3960078711;3960078203;3960077670;3960077255;3960076712;3960076267;3960075531;3960075322;3960074558;3960074350;3960073705;3960073499;3960066335;3960065987",,"73 units","Blood products, collected from donors whose suitability to donate were not adequately determined, were distributed.",7/5/2011,"07/05/2011",7/31/2013,"07/31/2013"
"Biologics",59507,"Terminated","Octapharma Plasma Inc","Omaha","NE","US","Voluntary: Firm Initiated","E-Mail","California","B-0771-13","Class III","Source Plasma","5020185308, 5020177821, 5020176494, 5020175673, 5020175310, 5020173228, 5020172653, 5020171774, 5020170189, 5020170018, 5020168215, 5020167663, 5020164608, 5020164282, 5020158730, 5020158015, 5020152164, 5020151620, 5020147950, 5020140986, 5020140595, 5020137968",".","22 units","Blood products, collected from a donor for whom donor suitability was not adequately determined, were distributed.",7/28/2011,"07/28/2011",5/1/2013,"05/01/2013"
"Biologics",59509,"Terminated","Octapharma Plasma, Inc.","Charlotte","NC","US","Voluntary: Firm Initiated","E-Mail","Austria","B-1701-13","Class III","Source Plasma","5250051627, 5250051321, 5250050643, 5250050422, 5250049708, 5250049571, 5250048584, 5250047966, 5250047708, 5250046985, 5250046641, 5250046068, 5250045742, 5250045161, 5250044825, 5250044144, 5250043890, 5250042937, 5250041894, 5250041609, 5250040334, 5250040089, 5250038529",".","23 units","Source Plasma, collected from donors who did not have a complete medical history interview, was distributed.",7/1/2011,"07/01/2011",7/24/2013,"07/24/2013"
"Biologics",59516,"Terminated","Octapharma Plasma, Inc.","Fort Worth","TX","US","Voluntary: Firm Initiated","FAX","CA, Switzerland","B-1064-13","Class III","Source Plasma","5200026069, 5200026406, 5200027561, 5200027908, 5200028505, 5200028965, 5200029669, 5200030096, 5200030750, 5200034043, 5200034835, 5200035230, 5200035752, 5200036034, 5200036604, 5200036928, 5200037499, 5200037813, 5200038699, 5200039079, 5200039639",".","21 units","Blood products, collected from a donor for whom donor suitability was not adequately determined, were distributed.",7/6/2011,"07/06/2011",5/1/2013,"05/01/2013"
"Food",59566,"Ongoing","Good Source Incorporated","Carlsbad","CA","US","Voluntary: Firm Initiated","E-Mail","IL, NE, RI, WY, CA, NV","F-1594-2013","Class II","Vegetarian Burger Mix, Item #VB 100, Pack size: 25lbs.","Lot#12173, 12305, 13065",".","159 cases","Good Source Solutions is recalling Vegetarian Burger Mix because it may be contaminated with Salmonella. The recalled product contains Soy Protein Isolate that is on recall by CHS Inc. for Salmonella.",5/23/2013,"05/23/2013",7/10/2013,"07/10/2013"
"Biologics",59676,"Terminated","DCI Biologicals LLC","Gallup","NM","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","PA; UK, Israel","B-0862-13","Class II","Source Plasma","LU0379044; LU0379710; LU0380678; LU0381529; LU0382702; LU0383550; LU0384610; LU0385521; LU0386735; LU0387674; LU0388895; LU0389714; LU0390974; LU0391873; LU0392808; LU0393902; LU0394735; LU0395923; LU0418962; LU0419548; LU0420344; LU0421067; LU0421920; LU0422596; LU0423523; LU0424104; LU0424957; LU0425579; LU0426965; LU0427689; LU0428136; LU0428868; LU0429392; LU0429948; LU0430416; LU0431140; LU0431634; LU0397683; LU0398242; LU0398772; LU0399475; LU0400792; LU0401796; LU0402477; LU0403532; LU0404243; LU0406646; LU0407300; LU0408032; LU0408728; LU0409541; LU0410086; LU0410755; LU0411395; LU0412154; LU0412765; LU0413474; LU0414192; LU0414872; LU0415373; LU0415989; LU0416724; LU0417668; LU0418175; LU0432362; LU0432817; LU0433490; LU0434088; LU0434843; LU0435914; LU0436313; LU0437069; LU0437557; LU0438224; LU0439884; LU0440501; LU0440922; LU0444081; LU0444732; LU0445705; LU0446123; LU0446727; LU0447178; LU0447842; LU0448263; LU0448895",,"87 units","Blood products, collected from a donor in which donor suitability was not adequately determined, were distributed.",6/16/2011,"06/16/2011",4/3/2013,"04/03/2013"
"Biologics",59696,"Terminated","Blood Centers of the Pacific","San Francisco","CA","US","Voluntary: Firm Initiated","Telephone","CA","B-0215-13","Class III","Red Blood Cells Leukocytes Reduced Irradiated","W117011433855",".","1 unit","Blood products, collected using scales that did not meet the acceptable quality control specifications, were distributed.",6/28/2011,"06/28/2011",1/16/2013,"01/16/2013"
"Biologics",59696,"Terminated","Blood Centers of the Pacific","San Francisco","CA","US","Voluntary: Firm Initiated","Telephone","CA","B-0214-13","Class III","Red Blood Cells Leukocytes Reduced","W117011433853, W117011433861, W117011433878, W117011433887 ",".","4 units","Blood products, collected using scales that did not meet the acceptable quality control specifications, were distributed.",6/28/2011,"06/28/2011",1/16/2013,"01/16/2013"
"Biologics",59720,"Terminated","Octapharma Plasma, Inc.","Omaha","NE","US","Voluntary: Firm Initiated","FAX","California","B-1304-13","Class II","Source Plasma","5020156275, 5020157029, 5020157686, 5020158548, 5020159159, 5020160229, 5020160746, 5020161804, 5020162349, 5020162989, 5020164038, 5020164411, 5020165651, 5020165875, 5020167671, 5020171649, 5020172098, 5020172873, 5020173290, 5020174072, 5020174413, 5020175052, 5020175504, 5020176255, 5020176753, 5020177456, 5020178050",".","27 units","Blood products, collected from a donor who was previously deferred, were distributed.",7/18/2011,"07/18/2011",5/1/2013,"05/01/2013"
"Biologics",59790,"Terminated","Talecris Plasma Resources, Inc.","Research Triangle Park","NC","US","Voluntary: Firm Initiated","FAX","NC","B-1154-13","Class II","Source Plasma","3720428066; 3720425381; 3720421643; 3720420290; 3720418232; 3720416926; 3720415044; 3720413553; 3720411637; 3720410338; 3720407547; 3720405571; 3720404375; 3720402283; 3720400924; 3720398718; 3720397548; 3720394685; 3720392539; 3720390508; 3720388882; 3720386356; 3720384555; 3720382661; 3720380724; 3720379181; 3720377420; 3720375711; 3720370641; 3720368970; 3720364462; 3720362699; 3720360261",,"33 units","Blood products, collected from a donor whose physical exam was incomplete, were distributed.",8/3/2011,"08/03/2011",5/8/2013,"05/08/2013"
"Biologics",60141,"Terminated","New York Blood Center, Inc.","New York","NY","US","Voluntary: Firm Initiated","Letter","NY, NJ, PA, CA, NC","B-0519-13","Class II","Red Blood Cells (Apheresis) Leukocytes Reduced","W047011325181 (2 units), W047011333860 (2 units), W047011343932 (2 units), W047011350111 (2 units)",".","8 units","Blood products, collected from donors for whom donor suitability was not adequately determined, were distributed.",10/7/2011,"10/07/2011",2/27/2013,"02/27/2013"
"Biologics",60141,"Terminated","New York Blood Center, Inc.","New York","NY","US","Voluntary: Firm Initiated","Letter","NY, NJ, PA, CA, NC","B-0524-13","Class II","Plasma Cryoprecipitate Reduced","W047011342870, W047011345097",".","2 units","Blood products, collected from donors for whom donor suitability was not adequately determined, were distributed.",10/7/2011,"10/07/2011",2/27/2013,"02/27/2013"
"Biologics",60141,"Terminated","New York Blood Center, Inc.","New York","NY","US","Voluntary: Firm Initiated","Letter","NY, NJ, PA, CA, NC","B-0515-13","Class II","Platelets Pheresis Leukocytes Reduced Irradiated","W047011326254, W047011326489, W047011339265, W047011339427",".","4 units","Blood products, collected from donors for whom donor suitability was not adequately determined, were distributed.",10/7/2011,"10/07/2011",2/27/2013,"02/27/2013"
"Biologics",60141,"Terminated","New York Blood Center, Inc.","New York","NY","US","Voluntary: Firm Initiated","Letter","NY, NJ, PA, CA, NC","B-0521-13","Class II","Cryoprecipitated AHF, Pooled","W047011328328, W047011328374, W047011341225, W047011351793, W047011467903, W047011467980",".","6 units","Blood products, collected from donors for whom donor suitability was not adequately determined, were distributed.",10/7/2011,"10/07/2011",2/27/2013,"02/27/2013"
"Biologics",60141,"Terminated","New York Blood Center, Inc.","New York","NY","US","Voluntary: Firm Initiated","Letter","NY, NJ, PA, CA, NC","B-0518-13","Class II","Platelets Pheresis Leukocytes Reduced","W047011325144 (2 units), W047011341398 (2 units), W047011326254, W047011329482 (2 units), W047011348802 (2 units), W047011326489, W047011332206",".","11 units","Blood products, collected from donors for whom donor suitability was not adequately determined, were distributed.",10/7/2011,"10/07/2011",2/27/2013,"02/27/2013"
"Biologics",60141,"Terminated","New York Blood Center, Inc.","New York","NY","US","Voluntary: Firm Initiated","Letter","NY, NJ, PA, CA, NC","B-0522-13","Class II","Red Blood Cells Leukocytes Reduced Irradiated","W047011332975, W047011333909, W047011336625 (2 units), W047011338416, W047011338548, W047011342870",".","7 units","Blood products, collected from donors for whom donor suitability was not adequately determined, were distributed.",10/7/2011,"10/07/2011",2/27/2013,"02/27/2013"
"Biologics",60141,"Terminated","New York Blood Center, Inc.","New York","NY","US","Voluntary: Firm Initiated","Letter","NY, NJ, PA, CA, NC","B-0514-13","Class II","Red Blood Cells Leukocytes Reduced","W047011056156, W047011326288, W047011330978, W047011334076, W047011337255, W047011337381, W047011351793, W047011338532, W047011342807, W047011336499, W047011342268, W047011333963, W047011336452, W047011349758, W047011335665, W047011333350, W047011333374, W047011333379, W047011333639, W047011333978, W047011334415, W047011334422, W047011334456, W047011334645, W047011333639, W047011336682, W047011337465, W047011337580, W047011338365, W047011337942, W047011339511, W047011339543, W047011339863, W047011339875, W047011341197, W047011341225, W047011341577, W047011341654, W047011341697, W047011341943, W047011342052, W047011342061, W047011342456, W047011342822, W047011344129, W047011344906, W047011345097, W047011345107, W047011345129, W047011345528, W047011345752, W047011346513, W047011347560 (2 units), W047011347841, W047011351263, W047011326528",".","57 units","Blood products, collected from donors for whom donor suitability was not adequately determined, were distributed.",10/7/2011,"10/07/2011",2/27/2013,"02/27/2013"
"Biologics",60141,"Terminated","New York Blood Center, Inc.","New York","NY","US","Voluntary: Firm Initiated","Letter","NY, NJ, PA, CA, NC","B-0517-13","Class III","Recovered Plasma","W047011326288, W047011330967, W047011330978, W047011336499, W047011326528, W047011332975, W047011333350, W047011333374, W047011333379, W047011333639, W047011334415, W047011334456, W047011337580, W047011339543, W047011341943, W047011342456, W047011342822, W047011347560",".","18 units","Blood products, collected from donors for whom donor suitability was not adequately determined, were distributed.",10/7/2011,"10/07/2011",2/27/2013,"02/27/2013"
"Biologics",60141,"Terminated","New York Blood Center, Inc.","New York","NY","US","Voluntary: Firm Initiated","Letter","NY, NJ, PA, CA, NC","B-0523-13","Class II","Fresh Frozen Plasma","W047011336452",".","1 unit","Blood products, collected from donors for whom donor suitability was not adequately determined, were distributed.",10/7/2011,"10/07/2011",2/27/2013,"02/27/2013"
"Biologics",60141,"Terminated","New York Blood Center, Inc.","New York","NY","US","Voluntary: Firm Initiated","Letter","NY, NJ, PA, CA, NC","B-0520-13","Class II","Plasma Frozen within 24 hours (FP24)","W047011056156, W047011336625, W047011336682, W047011338416, W047011339863, W047011342052, W047011342061",".","7 units","Blood products, collected from donors for whom donor suitability was not adequately determined, were distributed.",10/7/2011,"10/07/2011",2/27/2013,"02/27/2013"
"Biologics",60141,"Terminated","New York Blood Center, Inc.","New York","NY","US","Voluntary: Firm Initiated","Letter","NY, NJ, PA, CA, NC","B-0516-13","Class II","Cryoprecipitated AHF","W047011330978, W047011333350, W047011333374, W047011333379, W047011333639, W047011334645, W047011333639, W047011337580, W047011339543, W047011342822, W047011344906, W047011345097",".","12 units","Blood products, collected from donors for whom donor suitability was not adequately determined, were distributed.",10/7/2011,"10/07/2011",2/27/2013,"02/27/2013"
"Biologics",60159,"Terminated","Talecris Plasma Resources","Research Triangle Park","NC","US","Voluntary: Firm Initiated","FAX","North Carolina","B-1522-13","Class II","Source Plasma","4200121733, 4200121009, 4200120541, 4200119892, 4200119445, 4200118401, 4200118072, 4200117188, 4200116950, 4200115891, 4200115583, 4200114690, 4200114409, 4200113424, 4200112815, 4200112247, 4200111781, 4200111182, 4200110583, 4200110061, 4200109379, 4200108583, 4200108356, 4200107097, 4200106713, 4200105612, 4200105244, 4200104240, 4200103792, 4200103001, 4200101666, 4200099990, 4200099607, 4200098799, 4200098502, 4200097683, 4200097454, 4200096654, 4200096265, 4200095655",,"40 units","Blood products, collected from a donor whose scheduled physical examination was incomplete, were distributed.",10/6/2011,"10/06/2011",7/3/2013,"07/03/2013"
"Food",60188,"Completed","Tortilleria Provincia","Bowling Green","KY","US","Voluntary: Firm Initiated","Visit","The product was only distributed in the state of Kentucky.","F-1046-2013","Class II","Yellow Corn Tortillas in 5 lb clear flexible plastic bags with green and yellow printing. Tortilleria Provincia 1200 B Clay Street Bowling Green, KY 42101","Manufacture dates from 09/19/2011 through 10/19/2011 and all expiration dates between 10/19/2011 and 11/19/2011. ",,"60-70 cases ( 6 pkgs/case)","During an FDA inspection at the firm, it was discovered that the firm uses, FD&C Yellow #5, in the manufacture of their tortillas. However, FD&C Yellow #5 is not listed in the ingredient statement.",10/19/2011,"10/19/2011",3/13/2013,"03/13/2013"
"Biologics",60297,"Terminated","Csl Plasma Inc","Wichita","KS","US","Voluntary: Firm Initiated","E-Mail","Switzerland, Germany, IL, MA, CA","B-2539-13","Class II","Source Plasma","41500410323; 41500406367; 41500361365; 41500358115; 41500693300; 41500388963; 41500312432; 41500297930; 41500284769; 41500280653; 41500379899; 41500376284; 41500240900; 41500236326; 41500232070; 41500213506; 41500201433; 41500156302; 41500143085; 41500139916; 41500127245; 41500151472; 41500107990; 41500097816; 41500095140; 41500190279; 41500178190; 41500289375; 41500260193; 41500304660; 41500252214; 41500396330; 41500373606; 41500230550; 41500221354; 41500213282; 41500204335; 41500146729; 41500115252; 41500109127; 41500101395; 41500196970; 41500196267; 41500110144; 41500089445; 41500082374; 41500080424; 41500191837",".","48 Units","Blood products, collected from a donor whose scheduled physical examination was incomplete, were distributed.",8/18/2011,"08/18/2011",10/30/2013,"10/30/2013"
"Devices",60480,"Ongoing","Terumo Cardiovascular Systems Corporation","Ann Arbor","MI","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution-USA (nationwide) including DC and Puerto Rico and the states of AK, AL, AR, AZ, CA, CO, CT, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, SC, SD, TN, TX, UT, VA, WA, WI, and WV and the countries of Jordan, CANADA, AUSTRALIA, Japan ,Hong Kong ,UNITED ARAB EMIRATES (UAE), BELGIUM, South Korea, Malaysia, Mexico, Philippines, Singapore, Taiwan, and Thailand.","Z-1732-2013","Class II","CDI Blood Parameter Monitoring System 500 with Arterial blood parameter modules and Hematocrit/Saturation probe. Intended for use during cardiopulmonary bypass procedures when continuous monitoring of arterial and/or venous pH, PCO2, PO2, K+, oxygen saturation, hematocrit, hemoglobin, and temperature are desired.","Catalog number: 500AV* and serial numbers: 0024, 0033, 0040, 0051, 1192, 1193, 1355,1356, 1420, 1423, 1464, 1465, 1467, 1468,1483,1504,1521-1524,1526,1527,1529,1530, 1602-1604, 1606, 1662, 2023, 2035, 2102-2107, 2800, 2901,2902, 3131-3135, 3261, 3262, 4132, 5330-5333, 5338-5340, 5578, and 5579.",".","3972 since 4/26/12","Terumo discovered through its own testing that CDI 500 Blood Parameter Monitoring System software contains unused (turned off) accuracy correction factors for slope (gain) and offset (bias) for Hematocrit/Saturation calculations.",2/27/2013,"02/27/2013",7/24/2013,"07/24/2013"
"Devices",60480,"Ongoing","Terumo Cardiovascular Systems Corporation","Ann Arbor","MI","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution-USA (nationwide) including DC and Puerto Rico and the states of AK, AL, AR, AZ, CA, CO, CT, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, SC, SD, TN, TX, UT, VA, WA, WI, and WV and the countries of Jordan, CANADA, AUSTRALIA, Japan ,Hong Kong ,UNITED ARAB EMIRATES (UAE), BELGIUM, South Korea, Malaysia, Mexico, Philippines, Singapore, Taiwan, and Thailand.","Z-1734-2013","Class II","CDI Blood Parameter Monitoring System 500 with Venous blood parameter module. Intended for use during cardiopulmonary bypass procedures when continuous monitoring of arterial and/or venous pH, PCO2, PO2, K+, oxygen saturation, hematocrit, hemoglobin, and temperature are desired.","Catalog number: 500V* and serial numbers: 1564-1566",".","3972 units since 4/26/12","Terumo discovered through its own testing that CDI 500 Blood Parameter Monitoring System software contains unused (turned off) accuracy correction factors for slope (gain) and offset (bias) for Hematocrit/Saturation calculations.",2/27/2013,"02/27/2013",7/24/2013,"07/24/2013"
"Devices",60480,"Ongoing","Terumo Cardiovascular Systems Corporation","Ann Arbor","MI","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution-USA (nationwide) including DC and Puerto Rico and the states of AK, AL, AR, AZ, CA, CO, CT, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, SC, SD, TN, TX, UT, VA, WA, WI, and WV and the countries of Jordan, CANADA, AUSTRALIA, Japan ,Hong Kong ,UNITED ARAB EMIRATES (UAE), BELGIUM, South Korea, Malaysia, Mexico, Philippines, Singapore, Taiwan, and Thailand.","Z-1730-2013","Class II","CDI Blood Parameter Monitoring System 500 with Arterial and Venous blood parameter modules and Hematocrit/Saturation probe. Intended for use during cardiopulmonary bypass procedures when continuous monitoring of arterial and/or venous pH, PCO2, PO2, K+, oxygen saturation, hematocrit, hemoglobin, and temperature are desired.","Catalog number: 500AVHCT* and serial numbers: 0012, 1001-1022, 1024, 1028, 1032, 1033,1036, 1038, 1039, 1041-1044, 1046, 1047,1049-1053,1059,1063,1066-1071,1075,1096,1097,1101-1105, 1111-1304-1309,1312-1315,1321,1332-1334,13401344,1350-1354, 1357, 1358, 1379-1383, 13891393,1399-1408,1414-1418, 1421, 1422, 14241433, 1439-1443, 1449-1453, 1459-1463, 1466,1479, 1480, 1494, 1525, 1554, 1597-1601,1605,1617-1631,1637-1646,1657-1661,16721676,1682-1686,1697-1701,1712-1716, 1733-1737, 1787-1789, 1805-1809, 1815-1819, 1830, 1844-1846, 1857-1860, 1886-1890, 1901-1905,1916-1920, 1926-1930, 1936-1940, 1953-1974,1976-1985, 2029-2034, 2036-2038, 2040, 2045, 2059-2063, 2065-2067, 2070-2077, 2086, 2097-2101, 2109-2111, 2113-2115, 2123-2131, 2138-2142, 2149-2155, 2177-2182, 2185-2187, 2189,2195-2199, 2214, 2216-2219, 2224, 2228-2231, 2243-2245, 2249-2253, 2255-2258, 2260, 2263, 2265-2268, 2275-2277, 2279, 2285-2291, 22952298, 2313-2321, 2323-2329, 2338-2354, 2357, 2366,2368-2375,2377,2392,2403-2408,24172426, 2432-2436, 2439-2444, 2453-2458, 2463-2467, 2470-2472, 2476-2483, 2487-2503, 2514-2517,2521-2525,2541-2556,2565-2582,2587-2603, 2629-2633, 2635-2642, 2646, 2647, 2656, 2661,2662,2664-2680,2689-2691,2695,2696, 2701-2708, 2710-2716, 2722-2727, 2737, 2742-2747, 2757-2773, 2783, 2784, 2788, 2793-2795, 2802,2805-2808,2815-2820,2837-2839,28462849, 2865-2870, 2880-2889, 2892-2895, 2906-2908,2913- 2915,2920,2921,2924-2926, 2937-2940, 2942-2947, 2952, 2958-2975, 2979-2983, 2990-2999, 3008-3010, 3022-3027, 3040, 3041, 3052-3055, 3073-3075, 3083-3087, 3096, 3115, 3116, 3139-3145, 3152, 3153, 3155-3162, 3169-3182, 3190-3196, 3214-3220, 3225-3228, 3232, 3238-3245, 3248, 3249, 3264-3268, 3287, 3288, 3291-3306, 3314-3323, 3329-3334, 3340-3349, 3354-3357, 3369-3373, 3383-3391, 3394-3397, 3402-3406, 3416, 3418-3427, 3434-3437, 34413447, 3449-3456, 3458-3462, 3469-3472, 3481, 3482, 3489, 3490, 3500-3503, 3509, 3510, 3518, 3534, 3535, 3541-3545, 3571-3573, 35903609, 3612-3619, 3624-3628, 3636-3639, 36433645, 3669-3681, 3698-3703, 3715, 3716",".","3972 units since 4/26/12","Terumo discovered through its own testing that CDI 500 Blood Parameter Monitoring System software contains unused (turned off) accuracy correction factors for slope (gain) and offset (bias) for Hematocrit/Saturation calculations.",2/27/2013,"02/27/2013",7/24/2013,"07/24/2013"
"Devices",60480,"Ongoing","Terumo Cardiovascular Systems Corporation","Ann Arbor","MI","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution-USA (nationwide) including DC and Puerto Rico and the states of AK, AL, AR, AZ, CA, CO, CT, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, SC, SD, TN, TX, UT, VA, WA, WI, and WV and the countries of Jordan, CANADA, AUSTRALIA, Japan ,Hong Kong ,UNITED ARAB EMIRATES (UAE), BELGIUM, South Korea, Malaysia, Mexico, Philippines, Singapore, Taiwan, and Thailand.","Z-1733-2013","Class II","CDI Blood Parameter Monitoring System 500 with Arterial blood parameter module. Intended for use during cardiopulmonary bypass procedures when continuous monitoring of arterial and/or venous pH, PCO2, PO2, K+, oxygen saturation, hematocrit, hemoglobin, and temperature are desired.","Catalog number: 500A* and serial numbers: 1211,1559-1563,1663-1666,1722-1727,1754-1758, 1776, 1795, 1951, 1952, 2016, 2112, 2117, 2190, 2246, 2273, 2274, 2322, 2355, 2356,2389-2391, 2393, 2394, 2397, 2634, 2700, 2801, 2804, 2860, 2890, 2891, 3011-3013, 3125, 3146, 3263, 3289, 3410, 3417, 3480, 3629-3631, 3646-3648, 3661, and 5349.",".","3972 units since 4/26/12","Terumo discovered through its own testing that CDI 500 Blood Parameter Monitoring System software contains unused (turned off) accuracy correction factors for slope (gain) and offset (bias) for Hematocrit/Saturation calculations.",2/27/2013,"02/27/2013",7/24/2013,"07/24/2013"
"Devices",60480,"Ongoing","Terumo Cardiovascular Systems Corporation","Ann Arbor","MI","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution-USA (nationwide) including DC and Puerto Rico and the states of AK, AL, AR, AZ, CA, CO, CT, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, SC, SD, TN, TX, UT, VA, WA, WI, and WV and the countries of Jordan, CANADA, AUSTRALIA, Japan ,Hong Kong ,UNITED ARAB EMIRATES (UAE), BELGIUM, South Korea, Malaysia, Mexico, Philippines, Singapore, Taiwan, and Thailand.","Z-1731-2013","Class II","CDI Blood Parameter Monitoring System 500 with Arterial blood parameter modules and Hematocrit/Saturation probe. Intended for use during cardiopulmonary bypass procedures when continuous monitoring of arterial and/or venous pH, PCO2, PO2, K+, oxygen saturation, hematocrit, hemoglobin, and temperature are desired.","Catalog number: 500AHCT* and serial numbers: 1023,1025-1027,1029-1031, 1034,1035,1037,1040, 1045, 1048, 1054-1058, 1060-1062, 1064, 1065, 1072-1074, 1076-1095,1098-1100,1106-1110,1114,1116-1129,1131,1132,1141-1145, 1153-1165,1169-1180,1186-1191,1194-1210, 1212-1215,1221, 1230, 1237-1243,1249-1253,1256-1260,1265-1269,1275-1284,1290-1294,1300-1303, 1310, 1311, 1316-1320, 1322-1331,1335-1339,1345-1349,1359, 1378,1384-1388, 1394-1398,1409-1413,1419,1434-1438,1444-1448, 1454-1458, 1469-1478, 1481, 1482, 1484-1493,1495-1503,1505-1520,1528,1531-1553, 1555-1558,1567-1596,1607-1616,1632-1636,1647-1656,1667-1671,1677-1681,1687-1696, 1702-1711,1717-1721,1728-1732,1738-1753, 1759-1775,1777-1786,1790-1794,1796-1804,1810-1814,1820-1829,1831-1843,1847-1850, 1856, 1861-1885, 1891-1900, 1906-1915,1921-1925,1931-1935,1941-1950,1975,1986-2015, 2017-2022, 2024-2028, 2039, 2041-2044, 2046-2058, 2064, 2068, 2069, 2078-2085, 2087-2096, 2108, 2116, 2118- 2122, 2132-2137, 2143-2148, 2156-2176, 2183, 2184, 2188, 2191-2194, 2200-2213, 2215, 2220-2223, 2225-2227, 2232-2242, 2247, 2248, 2254, 2259,2261, 2262, 2264, 2269-2272, 2278, 2280-2284, 2292-2294, 2299-2312,2330-2337, 2353, 2359-2363, 2376, 2378-2388, 2398-2402, 2409-2416, 2427-2431, 2437, 2438, 2445-2452, 2459-2462, 2468, 2469, 2473-2475, 2484-2486, 2505-2513, 2518-2520, 2526-2540, 2557-2564, 2583-2586, 2604-2628, 2643-2645, 2648-2655, 2657-2660, 2663, 2684-2688,2692-2694,2697-2699, 2709, 2717-2721, 2728-2736, 2738-2741, 2748-2756, 2774-2782, 2785-2787, 2789-2792, 2796-2799, 2803, 2809-2814,2821-2836,2840-2845,2850-2859,2861-2864, 2871-2879, 2896-2900, 2903-2905, 2909-2912, 2916-2919, 2922, 2923, 2927-2936, 2941, 2948-2951, 2953-2957, 2976-2978, 2984-2989, 3000-3007, 3014-3021, 3028-3039, 3042-3051, 3056-3072, 3076-3082, 3088-3095, 3097-3114, 3117-3124,3126-3130,3136-3138,3147-3151, 3154,3163-3168,3183-3189, 3197-3213,3221-3224,3229-3231,3233-3237,3246,3247,3250-3260, 3269-3286,3290,3307-3313,3324-3328, 3335-3339, 3350-3353, 3358-3368, 3374-3382, 3392, 3393, 3398-3401, 3407-340",".","3972 unit since 4/26/12","Terumo discovered through its own testing that CDI 500 Blood Parameter Monitoring System software contains unused (turned off) accuracy correction factors for slope (gain) and offset (bias) for Hematocrit/Saturation calculations.",2/27/2013,"02/27/2013",7/24/2013,"07/24/2013"
"Biologics",60488,"Terminated","DCI Biologicals LLC","Gallup","NM","US","Voluntary: Firm Initiated","FAX","CA","B-0399-13","Class II","Source Plasma","SS0028297, SS0028810, SS0029396, SS0029992, SS0030710, SS0031173, SS0032411, SS0032571, SS0033526, SS0034910, SS0033790, SS0035135, SS0040286, SS0040977, SS0041971, SS0042322, SS0046118, SS0046508, SS0049341, SS0054262, SS0054851, SS0055786, SS0056509",".","23 units","Blood products, collected from a donor with a history of high-risk behavior, were distributed.",10/26/2011,"10/26/2011",2/27/2013,"02/27/2013"
"Food",60546,"Ongoing","Giant Eagle","Pittsburgh","PA","US","Voluntary: Firm Initiated","E-Mail","Product was distributed to Giant Eagle Stores in MD, OH, PA and WV.","F-1308-2013","Class II","Giant Eagle Lotsa Chocolate Chip Cookies","Lot numbers 073013 and 072313",,"170 cases","Labels do not accurately state ingredients/nutrition facts/allergens. An incorrect label was placed on this product that does not declare soy lecithin while the actual product contains soy lecithin.",2/26/2013,"02/26/2013",4/17/2013,"04/17/2013"
"Devices",60555,"Terminated","Karl Storz Endoscopy America Inc","El Segundo","CA","US","Voluntary: Firm Initiated","Letter","Nationwide distribution: USA including states of: IL, CA, WV, TX, SC, WI, NY, PA, NE, NJ, MD, OH, IA, and NC.","Z-1216-2013","Class II","KARL STORZ Photodynamic Diagnosis (PDD) D-Light C System, Instruction Manuals: PDD Telescopes, Tricam SL II, and PDD Camera Heads. Used as an optional accessory to white light cystoscopy when used in combination with the diagnostic imaging drug Cysview.","The device Instruction Manual recall, which includes: 1) Telescope, 2) Camera Head, and 3) Camera System. Serial Numbers: ZZ2008 ZZ2016 ZZ2012 ZZ2019 TY2024 ZZ2013 TY2026 TY2025 TY2028 TY2021 ZZ2007 ZZ2020 TX2036 TX2033 ZZ2017, and TX2035.",".","15 units","The recall was initiated because Karl Storz has confirmed that the Photodynamic Diagnosis (PDD) D-Light C System instruction manuals have important safety-related changes. ",8/16/2012,"08/16/2012",5/15/2013,"05/15/2013"
"Devices",60695,"Ongoing","Terumo Cardiovascular Systems Corporation","Ann Arbor","MI","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution.","Z-0802-2013","Class II","Terumo CDI 101 Hematocrit/Oxygen Saturation Monitoring System. Monitors blood/oxygen saturation, hematocrit and hemoglobin levels.","Catalog number: 101 and Serial Numbers: 0503, 1000, 1017, 1070, 1071, 1073, 1074, 1076, 1077, 1080, 1082, 1083, 1107-1110, 1115-1117,1124,1126-1134, 1136, 1137, 1139-1146, 1148-1152, 1154-1156, 1159-1162, 1164-1166, 1168-1177, 1182, 1185-1190, 1192,1193, 1195, 1197, 1198, 1225, 1228, 1229, 1237, 1239-1241,1243-1245,1247, 1249-1326, 1332-1339, 1344-1347, 1349, 1350-1363, 1365-1409, 1411-1436,1438, 1440-1447, 1449-1453, 1455-1463,1465-1482,1484-1492,1494-1552,1555-1565, 1567-1600,1602,1605-1607,1609-1611,1613-1623,1625-1629,1632-1651,1653, 1655-1660, 1662-1664, 1666, 1667,1669-1679,1681-1684,1686,1689-1691, 1693-1710,1712-1715,1717-1750,1752-1757,1759-1771,1773-1785,1787,1788,1790-1809, 1811-1831,1833,1838,1839,1855-1858,1866, and TK001-TK011.",,"622 units","Inaccurate readings. Software contains unused (turned off) accuracy correction factors for slope (gain) and offset (bias) for Hematocrit/Saturation calculations. The accuracy on any cuvette size did not meet the specifications.",11/1/2010,"11/01/2010",2/20/2013,"02/20/2013"
"Devices",60906,"Terminated","Abbott Vascular","Temecula","CA","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution-USA (nationwide) and the countries of Austria, Belgium, China, Germany, Spain, France, United Kingdom, Italy, Pakistan, Poland, Russia, Slovakia, Taiwan, and South Africa.","Z-0757-2013","Class II","Brand Name: RX Accunet Embolic Protection System Common Name: RX Accunet EPS. Part Numbers: 101649-45, 1011649-55, 1011649-65, 1011649-75, 1011650-55, 1011650-65, 1011651-45, 1011651-55. The RX Accunet EPS is indicated for use as a guide wire and embolic protection system.","Lot Number: 1081061, 1082561, 1091361, 1080561, 1081761, 1090261, 1091561, 1100461, 1080361, 1081661, 1090161, 1090861, 1092361, 1080861, 1082661, 1100761, 1081761, 1092861, 1082461, 1081161, 1082261, 1083061, 1081961, 1093061.",".","1253 units (962 units in the US & Puerto Rico)","The recall was initiated because Abbot Vascular has discovered that the identified lots of the RX Accunet Embolic Protection System may exhibit difficult removal of the peel away sheath due to higher than normal wall thickness.",11/30/2011,"11/30/2011",2/6/2013,"02/06/2013"
"Biologics",61069,"Terminated","The Blood Alliance, Inc.","Jacksonville","FL","US","Voluntary: Firm Initiated","FAX","Florida, Georgia, South Carolina","B-1060-13","Class II","Red Blood Cells"," W118811502204, W118811301264, W118811331295",".","3 units","Blood products, collected from donors who may have traveled to an area considered endemic for malaria, were distributed.",12/14/2011,"12/14/2011",5/1/2013,"05/01/2013"
"Biologics",61069,"Terminated","The Blood Alliance, Inc.","Jacksonville","FL","US","Voluntary: Firm Initiated","FAX","Florida, Georgia, South Carolina","B-1059-13","Class II","Red Blood Cells (Apheresis) Leukocytes Reduced","W118811534577 (2 units)",".","2 units","Blood products, collected from donors who may have traveled to an area considered endemic for malaria, were distributed.",12/14/2011,"12/14/2011",5/1/2013,"05/01/2013"
"Biologics",61069,"Terminated","The Blood Alliance, Inc.","Jacksonville","FL","US","Voluntary: Firm Initiated","FAX","Florida, Georgia, South Carolina","B-1058-13","Class II","Red Blood Cells Leukocytes Reduced","W118811574884, W118811503513, W118811573950, W118811574168, W118811573235",".","5 units","Blood products, collected from donors who may have traveled to an area considered endemic for malaria, were distributed.",12/14/2011,"12/14/2011",5/1/2013,"05/01/2013"
"Devices",61212,"Terminated","Beckman Coulter Inc.","Brea","CA","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution-USA (nationwide) and the countries of Argentina, Australia, Austria, Bangladesh, Belgium, Brazil, Canada, Chile, China, Colombia, Costa Rica, Czech Republic, Egypt, El Salvador, Ethiopia, France, Germany, Greece, India, Indonesia, Ireland, Italy, Japan, Jordan, Kazakhstan, Lebanon, Libyan Arab Jamahiriya, Liechtenstein, Macao, Malaysia, Mexico, Netherlands, Nigeria, Pakistan, Panama, Philippines, Puerto Rico, Romania, Russian Federation, Serbia, Singapore, Spain, Switzerland, Taiwan, Thailand, Turkey, United Arab Emirates, United Kingdom, Venezuela, Viet Nam, and Zambia.","Z-0613-2013","Class II","Access Immunoassay Systems Total T4 Calibrators, Part Number: 33805. The Access Total T4 Calibrators are intended to calibrate the Access Total T4 assay for the quantitative determination of total thyroxine (T4) levels in human serum and plasma using the Access Immunoassay Systems. Total T4 assay results are used for diagnosis and confirmation of thyroid disorders such as hyper- and hypothyroidism.","019818, 021654, 024072",".","6,634 units total (2,742 units in US)","A recall communication was initiated because Beckman has identified that Access Total T4 calibrator lots 019818, 021654, and 024072 do not meet their 12 month expiration date claim.",7/27/2011,"07/27/2011",1/2/2013,"01/02/2013"
"Devices",61315,"Completed","DePuy Orthopaedics, Inc.","Warsaw","IN","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution - USA Nationwide including the state of VA and the country of Ireland.","Z-1366-2013","Class II","Pinnacle Hip Solutions ALTRX Polyethylene Acetabular Liner, Ref 1221-36-452 Product Usage: An acetabular liner is used in combination with other implants for total hip arthroplasty is intended to provide increased patient mobility and reduce pain by replacing the damaged hip joint articulation in patients where there is evidence of sufficient sound bone to seat and support the components. ","product code1221-36-452, lot 187460. ",".","20 liners ","DePuy Orthopaedics, Inc. (DePuy) is issuing a voluntary recall of one lot of the AltrX'' liner because the product was incorrectly labeled on the box. The box was labeled for a 36IDX52OD +4 Neutral Liner, but the product enclosed was a 36IDX56OD Neutral Liner. Three ( 3 ) complaints were received in January 2012.",3/7/2012,"03/07/2012",5/29/2013,"05/29/2013"
"Biologics",61340,"Terminated","Dendreon Corporation","Union City","GA","US","Voluntary: Firm Initiated","Telephone","TX","B-0392-13","Class III","Sipuleucel-T","3044411",".","One unit","Provenge (sipuleucel-T), with an out-of-specification (OOS) assay result, was distributed. ",12/12/2011,"12/12/2011",1/30/2013,"01/30/2013"
"Biologics",61380,"Terminated","BioLife Plasma Services L.P.","Cheyenne","WY","US","Voluntary: Firm Initiated","FAX","California, Austria","B-0706-13","Class III","Source Plasma","11CWYD2770; 11CWYD2350; 11CWYC4816; 11CWYC4486; 11CWYC3904; 11CWYC3580; 11CWYC3052; 11CWYC2727; 11CWYC1908; 11CWYC1363; 11CWYC1017; 11CWYC0112; 11CWYB9556; 11CWYB9227; 11CWYB8692; 11CWYB7810; 11CWYB8359; 11CWYC2252; 09CWYA7624; 09CWYA8110; 09CWYA8874; 09CWYA9397; 09CWYB0181; 09CWYB0702; 09CWYB1521; 09CWYB2032; 09CWYB2858; 09CWYB3354; 09CWYC0658; 09CWYC1200; 09CWYC2126; 09CWYC2665; 09CWY3564; 09CWY4102; 09CWYC4978; 09CWYD3431; 09CWYD4255; 10CWY5744; 10CWYD6006; 10CWYD6456; 10CWYD6716; 11CWYA8273; 11CWYA8597; 11CWYA9130; 11CWYA9455; 11CWYB0013; 11CWYB0319; 11CWYB08113; 11CWYB1113; 11CWYB1698; 11CWYB2620; 11CWYB2959; 09CWYA4921; 09CWYA5431; 09CWYC5493; 09CWYC6358; 09CWYC6852; 09CWYC7476; 09CWYC8002; 09CWYC9034; 09CWYC9340; 09CWYD0187; 09CWYD0696; 09CWYD1533; 09CWYD2130; 09CWYD2883; 09CWYD5831; 09CWYD6643; 09CWYD7938; 09CWYD8390; 09CWYD9188; 09CWYE0484; 09CWYE0991; 09CWYE1861; 09CWYE3011; 09CWYE3488; 09CWYE4252; 09CWYE4762; 09CWYE5558; 09CWYE6013; 09CWYE6581; 09CWYE7041; 09CWYE9040; 09CWYE9501; 09CWYF0303; 09CWYF0777; 09CWYF2024; 09CWYF3719; 09CWYF4214; 09CWYF5840; 09CWYF6293; 09CWYF7066; 09CWYF7538; 09CWYF8331; 09CWYF8821; 09CWYG0329; 09CWYG1670; 09CWYG1998; 09CWYG2760; 09CWYG3243; 10CWYA0513; 10CWYA0975; 10CWYA1643; 10CWYA2128; 10CWYA2839; 10CWYA3357; 10CWYA4080; 10CWYA6281; 10CWYA6671; 10CWYA7286; 10CWYA8301; 10CWYA8704; 10CWYB1419; 10CWYB1814; 10CWYB2396; 10CWYB2797; 10CWYB3474; 10CWYB3851; 10CWYB4483; 10CWYB4874; 10CWYB5507; 10CWYB5868; 10CWYB6471; 10CWYB6845; 10CWYB7465; 10CWYB7831; 10CWYB8376; 10CWYB8714; 10CWYB9616; 10CWYC0114; 10CWYC0450; 10CWYC0980; 10CWYC1303; 10CWYC2809; 10CWYC3301; 10CWYC3620; 10CWYC4126; 10CWYC4447; 10CWYC4954; 10CWYC5423; 10CWYC5730; 10CWYC6154; 10CWYC6455; 10CWYC6894; 10CWYC8322; 10CWYC8602; 10CWYC8985; 10CWYC9271; 10CWYC9672; 10CWYD0594; 10CWYD0945; 10CWYD1218; 10CWYD1629; 10CWYD1889; 10CWYD2329; 10CWYD2602; 10CWYD3040; 10CWYD3312; 10CWYD3688; 10CWYD3959; 10CWYD4373; 10CWYD5066; 10CWYD5311; 10CWYD7172; 10CWYD7444; 10CWYD7934; 10CWYD8200; 10CWYE0775; 10CWYE1104; 10CWYE1612; 10CWY21",,"236 units","Blood products, collected from a donor who was at risk for variant Creutzfeldt-Jakob Disease (vCJD), were distributed.",1/27/2012,"01/27/2012",3/20/2013,"03/20/2013"
"Devices",61554,"Ongoing","Advanced Neuromodulation Systems Inc.","Plano","TX","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution - 53 consignees out of the US.","Z-0894-2013","Class II","Advanced Neuromodulation Systems, Brio DBS System implantable neurostimulator, IPG or R-IPG, Model 6788 Implantable Pulse Generator.","Model number 6788. All lots manufactured prior to 03/16/2012 are being recalled.",,"388 units","Unintended Fluid ingress into the device header has been shown.",3/28/2012,"03/28/2012",3/6/2013,"03/06/2013"
"Biologics",61564,"Terminated","American National Red Cross (The)","Farmington","CT","US","Voluntary: Firm Initiated","FAX","CT, NY","B-0403-13","Class III","Red Blood Cells Leukocytes Reduced","033KX34123, 033KX34094, 033KX34095, 033KX34096, 033KX34097, 033KX34098, 033KX34099, 033KX34101, 033KX34102, 033KX34103, 033KX34104, 033KX34105, 033KX34106, 033KX34107, 033KX34124, 033KX34125, 033KX34126, 033KX34127, 033FN44900, 033FN44901, 033FN44890, 033FN44891, 033FN44893, 033FN44894, 033FN44895, 033FN44897, 033FN44898, 033FN44899, 033FN44879, 033FN44880, 033FN44881, 033FN44882, 033FN44883, 033FN44884, 033FN44885, 033FN44886, 033FN44887, 033FN44888, 033FN44889, 033KX34131, 033KX34132, 033KX34133, 033KX34134, 033KX34136, 033KX34138, 033KX34139, 033KX34140, 033KX34141, 033KX34129, 033KX34130, 033FN44851, 033FN44852, 033FN44853, 033FN44854, 033FN44855, 033FN44856, 033FN44857, 033FN44858, 033FN44859, 033FN44860, 033FN44862, 033FN44863, 033FN44864, 033FN44866, 033FN44868, 033FN44869, 033FN44870, 033FN44871, 033FN44873, 033FN44874, 033FN44875, 033FN44876, 033FN44878, 033KX34142, 033KX34143, 033KX34144, 033KX34145, 033KX34146, 033FN44847, 033FN44849, 033FN44850, 033KX34108, 033KX34109, 033KX34110, 033KX34111, 033KX34112, 033KX34113, 033KX34114, 033KX34115, 033KX34116, 033KX34117, 033KX34118, 033KX34119, 033KX34120, 033KX34121, 033KX34122, 033FN44903, 033FN44905, 033FN44906, 033FN44907, 033FN44908, 033FN44909, 033FN44910, 033FN44911, 033FN44912, 033FN44914",".","106 units","Blood products, for which the scale and Hemocue used during collection failed quality control testing, were distributed.",2/16/2012,"02/16/2012",2/27/2013,"02/27/2013"
"Biologics",61564,"Terminated","American National Red Cross (The)","Farmington","CT","US","Voluntary: Firm Initiated","FAX","CT, NY","B-0404-13","Class III","Red Blood Cells Leukocytes Reduced Irradiated","033KX34128, 033FN44892, 033FN44865, 033FN44846, 033FN44902, 033FN44913, 033FN44915",".","7 units","Blood products, for which the scale and Hemocue used during collection failed quality control testing, were distributed.",2/16/2012,"02/16/2012",2/27/2013,"02/27/2013"
"Devices",61611,"Ongoing","GE Healthcare, LLC","Waukesha","WI","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution - USA including AL, CT, FL, IL, MA, MO, NJ, NY, PA, TX VA, WA, WI and Internationally to TURKEY, TAIWAN, SWITZERLAND, SWEDEN, SOUTH AFRICA, NIGERIA, MALAYSIA, KOREA, JAPAN, INDIA, GERMANY, FRANCE, EGYPT, DENMARK, CHINA, CHILE, CANDA, BRAZIL, AUSTRIA, and GREAT BRITAIN.","Z-0754-2013","Class II","AdvantageSim MD versions 7.4 through 7.6, Model 5160092-2 Version 7.4, 5160092-3 Version 7.5, 5160092-4 version 7.6.","Mfg Lot or Serial # 00000L022E05AE 00000139595HP3 000000010003GS 000000410012GS 000000210016GS 000000210013GS 00000138998HP0 00000139435HP2 000000410010GS 000000410009GS 000000210005GS 000000210011GS 000000210012GS 000000210015GS 00000138991HP5 000000210014GS 000000310005GS 00000139574HP8 00000139604HP3 00000L026CC222 000000210010GS 000000010004GS 000000410011GS 000000410007GS 000000210023GS 000000210025GS 000000210026GS 000000210022GS 000000210024GS 000000410005GS 000000410006GS 000000310003GS 000000310002GS 000000210006GS 000000210007GS 000000210003GS 000000410004GS 000000310001GS 000000010001GS 000000210030GS 000000210008GS 000000410016GS 000000P8059001 000000210027GS 000000410008GS 000000410001GS 000000210017GS 000000210019GS 000000210021GS 000000210020GS 000000310008GS 000000210018GS 000000410014GS 000000210029GS 000000210004GS 000000210001GS 000000210009GS 000000410003GS 000000410013GS 000000210028GS 000000410017GS 000000410015GS 000000310007GS 000000310006GS 000000010005GS",".","65","It was reported by a customer site that when using GE AdvantageSim MD on Advantage Workstation, the series could be incorrectly labeled in image view when multiple series of an exam are loaded simultaneously in Advantage Sim MD and if their series dates are different. A mismatch of series label for structure sets may lead to under-treatment of a tumor due to too small coverage of volume treated. A second issue was discovered internally in which the Interpolation in Advantage Sim MD 7.5 would not give a correct result when some part wee removed from an existing structure. If the contour truncation is not recognized, it may lead to inappropriate irradiation of the patient.",5/24/2012,"05/24/2012",2/6/2013,"02/06/2013"
"Food",61696,"Terminated","Hong Lee Trading Inc","Brooklyn","NY","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Nationwide","F-1457-2013","Class I","Preserved Apricots -- NET WEIGHT 300gr (10.6oz) -- Ingredient: Salt, apricot, refined sugar. Firm on label: packed for Hong Lee Trading Inc., 225 Johnson Ave., Brooklyn, NY 11203. Product of Vietnam.","No codes",".","30 cases","The product contained undeclared sulfites (108.8 ppm) and undeclared Yellow #5 based on sampling and analysis by New York State Department of Agriculture and Markets. ",4/16/2012,"04/16/2012",6/5/2013,"06/05/2013"
"Biologics",61707,"Terminated","Delta Blood Bank","Stockton","CA","US","Voluntary: Firm Initiated","Letter","CA","B-0199-13","Class II","Red Blood Cells Leukocytes Reduced","W128711240444",".","1 unit","Blood product, collected from a donor who traveled to an area considered endemic for malaria, was distributed.",3/9/2012,"03/09/2012",1/16/2013,"01/16/2013"
"Devices",61718,"Ongoing","Stryker Howmedica Osteonics Corp.","Mahwah","NJ","US","Voluntary: Firm Initiated","Letter","Nationwide distribution, including the states of NY, NJ, CA and FL.","Z-0656-2013","Class II","Accolade TMZF Plus 127 degree Neck Angle V40 Hip Stem #2.5 and Accolade TMZF Plus 127 degree Neck Angle V40 Hip Stem #3.5, Howmedica Osteonics Corp. The intended use is for reconstruction of the head and neck of the femoral joint.","Catalog Number: 6021-2530 Lot #40264005 Catalog Number: 6021-3535 Lot #40163005. This lot was not received in the US.",".","6021-2530- four units; 6021-3535-","Stryker has received a report that single size 3.5 stem was packaged as size 2.5 stem resulting in a possible product mix.",10/23/2012,"10/23/2012",1/16/2013,"01/16/2013"
"Drugs",61725,"Ongoing","Teva Pharmaceuticals USA, Inc.","Sellersville","PA","US","Voluntary: Firm Initiated","Letter","Nationwide","D-128-2013","Class III","CABERGOLINE Tablets, 0.5 mg, RX only, 8 count bottles, Manufactured For: TEVA PHARMACEUTICALS USA, Sellersville, PA 18960 NDC 0093-5420-88","Lot number 6A007046V, exp 07/12",".","13,232 bottles","Impurities/Degradation Products: This lot of product will not meet the impurity specification over shelf life",4/24/2012,"04/24/2012",1/23/2013,"01/23/2013"
"Food",61735,"Ongoing","Dymatize Enterprises, LLC","Farmers Branch","TX","US","Voluntary: Firm Initiated","Letter","Product was distributed in the United States, Algeria, Australia, Bulgaria, Canada, Cyprus, Czech Republic, Dominican Republic, France, French Polynesia, Germany, Indonesia, Italy, Jordan, Korea, Mexico, Netherlands, Philipines, Portugal, Puerto Rico, Qatar, Russia, Slovenija, South Africa, Spain, Sweden, Switzerland, Thailand, Turkey, and United Kingdom.","F-1230-2013","Class I","Dymatize Nutrition XPAND Post Xtreme Mass Recovery System Fruit Punch 3.5 lb Manufactured & Distributed by Dymatize Enterprises, LLC, 13737 N. Stemmons FWY. Dallas, TX 75234 UPC 705016895625.","Lots 1244003, 1292006, 1340011, 1021107, 1075104, 1151111, and 1307105.",".","13,768 units","The product label declares whey but does not declare milk.",5/3/2012,"05/03/2012",3/27/2013,"03/27/2013"
"Food",61735,"Ongoing","Dymatize Enterprises, LLC","Farmers Branch","TX","US","Voluntary: Firm Initiated","Letter","Product was distributed in the United States, Algeria, Australia, Bulgaria, Canada, Cyprus, Czech Republic, Dominican Republic, France, French Polynesia, Germany, Indonesia, Italy, Jordan, Korea, Mexico, Netherlands, Philipines, Portugal, Puerto Rico, Qatar, Russia, Slovenija, South Africa, Spain, Sweden, Switzerland, Thailand, Turkey, and United Kingdom.","F-1231-2013","Class I","Dymatize Nutrition XPAND Post Xtreme Mass Recovery System Blue Raspberry 3.5 lb Manufactured & Distributed by Dymatize Enterprises, LLC, 13737 N. Stemmons FWY. Dallas, TX 75234 UPC 705016895601.","Lots 1292004, 1244004, 1025102, 1075115, and 1153101.",".","9,983 units","The product label declares whey but does not declare milk.",5/3/2012,"05/03/2012",3/27/2013,"03/27/2013"
"Food",61735,"Ongoing","Dymatize Enterprises, LLC","Farmers Branch","TX","US","Voluntary: Firm Initiated","Letter","Product was distributed in the United States, Algeria, Australia, Bulgaria, Canada, Cyprus, Czech Republic, Dominican Republic, France, French Polynesia, Germany, Indonesia, Italy, Jordan, Korea, Mexico, Netherlands, Philipines, Portugal, Puerto Rico, Qatar, Russia, Slovenija, South Africa, Spain, Sweden, Switzerland, Thailand, Turkey, and United Kingdom.","F-1229-2013","Class I","Dymatize Nutrition XPAND Post Xtreme Mass Recovery System Lemonade 3.5 lb Manufactured & Distributed by Dymatize Enterprises, LLC, 13737 N. Stemmons FWY. Dallas, TX 75234 UPC 705016895649","Lots 1244001, 1292001, 1021101, 1075102, and 1276102. ",".","9,962 units","The product label declares whey but does not declare milk.",5/3/2012,"05/03/2012",3/27/2013,"03/27/2013"
"Food",61777,"Terminated","Evergreen Orchard Farm, LLC","Hamilton","NJ","US","Voluntary: Firm Initiated","Letter","New Jersey, New York, Virginia and Maryland.","F-1342-2012","Class II","Korean Grape Juice, 110 mL metal foil pouch single service container. Made by Evergreen Orchard Farm, 1023 Yardville Allentown Road, Hamilton, NJ 08620 Product of USA. UPC #8907672547.","All product produced. Firm does not use product lot coding and/or expiration date(s).",".","Unknown ","Juice and paste products display incorrect labeling, product descriptions and formulations.",3/16/2012,"03/16/2012",12/11/2013,"12/11/2013"
"Food",61777,"Terminated","Evergreen Orchard Farm, LLC","Hamilton","NJ","US","Voluntary: Firm Initiated","Letter","New Jersey, New York, Virginia and Maryland.","F-1343-2012","Class II","Evergreen Farm Doen Jang (Soybean Paste). Net Wt, 70 ounces (4.4 LBS) in glass jars. 1023 Yardville Allentown Road, Hamilton NJ 08620. Product of USA. UPC# 89076725873","All product produced. Firm does not use product lot coding and/or expiration date(s).",".","Unknown ","Juice and paste products display incorrect labeling, product descriptions and formulations.",3/16/2012,"03/16/2012",12/11/2013,"12/11/2013"
"Food",61777,"Terminated","Evergreen Orchard Farm, LLC","Hamilton","NJ","US","Voluntary: Firm Initiated","Letter","New Jersey, New York, Virginia and Maryland.","F-1344-2012","Class II","Evergreen Farm Pear Juice Gochujang (Hot Peppeer Paste). Net Wt 70 ounce (4.4 LBS) glass jars. 1023 Yardville Allentown Road, Hamilton NJ 08620. Product of USA. UPC # 89076726177.","All product produced. Firm does not use product lot coding and/or expiration date(s).",".","Unknown","Juice and paste products display incorrect labeling, product descriptions and formulations.",3/16/2012,"03/16/2012",12/11/2013,"12/11/2013"
"Food",61777,"Terminated","Evergreen Orchard Farm, LLC","Hamilton","NJ","US","Voluntary: Firm Initiated","Letter","New Jersey, New York, Virginia and Maryland.","F-1341-2012","Class II","Korean Pear Juice in 120 mL metal foil pouch single service container. Made by Evergreen Orchard Farm, 1023 Yardville Allentown Road, Hamilton, NJ 08620. Product of USA. UPC# 809080300084.","All product produced. Firm does not use product lot coding and/or expiration date(s).",".","Unknown ","Juice and paste products display incorrect labeling, product descriptions and formulations.",3/16/2012,"03/16/2012",12/11/2013,"12/11/2013"
"Food",61789,"Completed","He Butt Grocery Company","San Antonio","TX","US","Voluntary: Firm Initiated","Press Release","TX","F-0994-2013","Class I","HEB Deli Sesame Chicken Entree UPC 0026960600000; HEB Deli HE Bowl Sesame Chicken UPC 0026967700000; HEB Deli Sesame Chicken Retail Pack UPC 0026521900000; HEB Deli Sesame Chicken UPC 0026704500000 ","All product sold prior to 05/03/12.",,"unknown","The product has the potential to be contaminated with salmonella.",5/2/2012,"05/02/2012",2/20/2013,"02/20/2013"
"Food",61789,"Completed","He Butt Grocery Company","San Antonio","TX","US","Voluntary: Firm Initiated","Press Release","TX","F-0993-2013","Class I","HEB Deli Lemon Grass Chicken Entree UPC 0026967100000; HEB Deli HE Bowl Lemon Grass Chicken UPC 0026967600000; HEB Deli Lemon Grass Chicken Retail Pack UPC 0026521800000; HEB Deli Lemon Grass Chicken UPC 0026705200000","All product sold prior to 05/03/12.",,"unknown","The product has the potential to be contaminated with salmonella.",5/2/2012,"05/02/2012",2/20/2013,"02/20/2013"
"Food",61789,"Completed","He Butt Grocery Company","San Antonio","TX","US","Voluntary: Firm Initiated","Press Release","TX","F-0992-2013","Class I","HEB Deli General Joes Chicken Entree, UPC 0026966900000; HEB Deli HE Bowl General Joes Chicken, UPC 0026967400000; HEB Deli General Joe's Chicken Retail Pack, UPC 0026520900000; HEB Deli General Joes Chicken UPC 0026703700000","All product sold prior to 05/03/12.",,"unknown","The product has the potential to be contaminated with salmonella.",5/2/2012,"05/02/2012",2/20/2013,"02/20/2013"
"Food",61789,"Completed","He Butt Grocery Company","San Antonio","TX","US","Voluntary: Firm Initiated","Press Release","TX","F-0995-2013","Class I","HEB Deli Sweet and Sour Chicken Entree UPC 0026967200000; HEB Deli HE Bowl Sweet and Sour Chicken UPC 0026967800000; HEB Deli Sweet and Sour Chicken UPC 0026705000000","All product sold prior to 05/03/12.",,"unknown","The product has the potential to be contaminated with salmonella.",5/2/2012,"05/02/2012",2/20/2013,"02/20/2013"
"Devices",61870,"Ongoing","Motorola Inc","Holtsville","NY","US","Voluntary: Firm Initiated","Letter","Nationwide distribution","Z-0516-2013","Class II","Motorola Solutions PCS3000/CS3070 Laser Utility/Peripheral Laser Products ","Motorola Solutions PCS3000/CS3070 Laser ",".","16,961 units domestically","It was discovered the CS3000/CS3070 was manufactured using the laser power settings for a Class 2 laser device instead of the Class 1 power levels as specified on the product label.",4/27/2012,"04/27/2012",2/6/2013,"02/06/2013"
"Devices",61879,"Ongoing","Varian Medical Systems, Inc.","Charlottesville","VA","US","Voluntary: Firm Initiated","Letter","US Nationwide Distribution","Z-0759-2013","Class II","Rectal Retractors, stainless steel, item # AL07289000, a component of Varian Medical Ring and Tandem Applicator Sets; Intended for use in Brachytherapy. ","All lots",".","344 pieces","A medical device used in brachytherapy may become contaminated and can cause infections, toxicity or allergic reactions.",4/12/2012,"04/12/2012",2/6/2013,"02/06/2013"
"Devices",61879,"Ongoing","Varian Medical Systems, Inc.","Charlottesville","VA","US","Voluntary: Firm Initiated","Letter","US Nationwide Distribution","Z-0760-2013","Class II","Rectal Retractors, titanium, item # AL07368000, a component of Varian Medical Ring and Tandem Applicator Sets; Intended for use in Brachytherapy. ","All lots",".","152 units","A medical device used in brachytherapy may become contaminated and can cause infections, toxicity or allergic reactions.",4/12/2012,"04/12/2012",2/6/2013,"02/06/2013"
"Food",61892,"Ongoing","Caribe Produce","San Juan","TX","US","Voluntary: Firm Initiated","Letter","NJ and NC","F-1643-2013","Class I","Caribena Brand papayas packed in 35 lb. cartons marked with the brand ''Caribena'' and ''Product of Mexico'' stamped on the side. Each papaya bears a label which states ''3112 CARIBENA Papaya MARADOL PRODUCT OF MEXICO www.grandeproduce.com'' Papayas are packed in boxes of 8-12 papayas per box","Each papaya bears a label which states ''3112 CARIBENA Papaya MARADOL PRODUCT OF MEXICO www.grandeproduce.com''. Lot # 115123",".","1,152 cartons each with 35 lbs. of product","Product has the potential to be contaminated with salmonella.",5/15/2012,"05/15/2012",7/17/2013,"07/17/2013"
"Drugs",61900,"Ongoing","InSo-Independent Contractor for West Coast Nutritionals,LTD","Allen","TX","US","Voluntary: Firm Initiated","Press Release","Nationwide in the United States, U.S. Virgin Islands, Puerto Rico and to the following locations: United Kingdom, United Arab Emirates, Turkey, Trinidad & Tobago, Thailand, Taiwan, Sweden, St. Maarten, Spain, South Africa, Singapore, Saudi Arabia, Russia, Romania, Qatar, Portugal, Poland, Philippines, Papua New Guinea, Pakistan, Oman, Norway, Nigeria, New Zealand, Netherlands Antilles, Netherlands, Mozambique, Montenegro, Mauritius, Malta, Maldives, Malaysia, Latvia, Kuwait, South Korea, Jordan, Japan, Jamaica, Italy, Ireland, Iraq, India, Hong Kong, Guatemala, Greece, Germany, France, England, Denmark, Cyprus, Curacao, Congo, Cayman Islands, Canada, Australia, Belize, and Turks and Caicos Islands.","D-326-2013","Class I","a) Firminite 805 mg is packaged in 2 count, 4 count, and 10 count capsules blister packs in a box, WWW.FIRMINITE.COM, b) Libidron 410 mg is packaged in 2 count, 4 count, and 10 count capsules blister packs in a box, WWW.LIBIDRON.COM , c)Extra Strength Instant Hot Rod 496 mg is packaged in 4 count and 10 count capsule blister packs in a box, www.HotRodExtraStrength.com","All lots ",,"8,000 blister packs","Marketed Without an Approved NDA/ANDA: These products found to contain undeclared tadalafil. Tadalafil is an FDA-approved drug for the treatment of male Erectile Dysfunction (ED), making these products unapproved new drugs.",5/18/2012,"05/18/2012",5/22/2013,"05/22/2013"
"Food",61912,"Ongoing","International Flavors & Fragrances, Inc","Carrollton","TX","US","Voluntary: Firm Initiated","Telephone","Domestically Nationwide and to Canada.","F-1234-2013","Class I","Nat Flavor Beef Marrow, IFF Code: ULL681883, Net Weight 50 lb, Batch 0004684926, Production Date 04/25/2012, For Manufacturing Use Only. ","IFF Code: ULL681883, Batch 0004684926, and Production Date 04/25/2012.",".","635.04 kg (28 x 22.68 kg)","Product has the potential to be contaminated with Salmonella.",5/17/2012,"05/17/2012",3/27/2013,"03/27/2013"
"Food",61912,"Ongoing","International Flavors & Fragrances, Inc","Carrollton","TX","US","Voluntary: Firm Initiated","Telephone","Domestically Nationwide and to Canada.","F-1236-2013","Class I","Beef, IFF code: SN418156, Net Weight 50 lb, Batch 0004714076, Production date 04/23/2012, For Manufacturing use only.","IFF code: SN418156, Batch 0004714076, and Production date 04/23/2012.",".","703.08 kg (31 x 22.68 kg)","Product has the potential to be contaminated with Salmonella.",5/17/2012,"05/17/2012",3/27/2013,"03/27/2013"
"Food",61912,"Ongoing","International Flavors & Fragrances, Inc","Carrollton","TX","US","Voluntary: Firm Initiated","Telephone","Domestically Nationwide and to Canada.","F-1232-2013","Class I","Grilled Chicken Marinade, IFF Code 3559317, Net Weight 50 Lb, Batch 0004700696, 004705802, and 004722458, Production Date 04/20/2012 and 05/01/2012, For Manufacturing Use Only. ","IFF Code 3559317, Batch 0004700696, and Production Date 04/20/2012. ",".","5488.56 kg (242 x 22.68 kg)","Product has the potential to be contaminated with Salmonella.",5/17/2012,"05/17/2012",3/27/2013,"03/27/2013"
"Food",61912,"Ongoing","International Flavors & Fragrances, Inc","Carrollton","TX","US","Voluntary: Firm Initiated","Telephone","Domestically Nationwide and to Canada.","F-1233-2013","Class I","Natural Chicken Flavor Seasoning, IFF Code: 3714201, Net Weight 50 lbs, Batch 0004706362, Production Date 04/25/2012, For Manufacturing Use Only.","IFF Code: 3714201, Batch 0004706362, and Production Date 04/25/2012.",".","2,676.24 kg (118 x 22.68 kg)","Product has the potential to be contaminated with Salmonella.",5/17/2012,"05/17/2012",3/27/2013,"03/27/2013"
"Food",61912,"Ongoing","International Flavors & Fragrances, Inc","Carrollton","TX","US","Voluntary: Firm Initiated","Telephone","Domestically Nationwide and to Canada.","F-1237-2013","Class I","Nat Beef FF, Iff Code ULL89721, Net Weight 50 Lb, Batch 0004696310, Production Date 04/23/2012, For Manufacturing Use Only.","Iff Code ULL89721, Batch 0004696310 and Production Date 04/23/2012",".","68.04 kg (3 x 22.68 kg)","Product has the potential to be contaminated with Salmonella.",5/17/2012,"05/17/2012",3/27/2013,"03/27/2013"
"Food",61912,"Ongoing","International Flavors & Fragrances, Inc","Carrollton","TX","US","Voluntary: Firm Initiated","Telephone","Domestically Nationwide and to Canada.","F-1238-2013","Class I","Bean Sauce Seasoning, IFF Code: 76185, Net Weight 25 lb, Production date:04/26/2012, For Manufacturing use only. ","Batch: 0004711598, Production date 04/26/2012, Iff Code 76185.",".","158.76 kg (14 x 11.34 kg)","Product has the potential to be contaminated with Salmonella.",5/17/2012,"05/17/2012",3/27/2013,"03/27/2013"
"Food",61912,"Ongoing","International Flavors & Fragrances, Inc","Carrollton","TX","US","Voluntary: Firm Initiated","Telephone","Domestically Nationwide and to Canada.","F-1235-2013","Class I","Nat Flv Beef FF, IFF Code 13580894, Net Weight 50 lb, Batch 0004702577, Production Date 04/23/2012, For Manufacturing Use Only. ","IFF Code 13580894, Batch 0004702577, and Production Date 04/23/2012. ",".","1,338.12 kg (59 x 22.68 kg)","Product has the potential to be contaminated with Salmonella.",5/17/2012,"05/17/2012",3/27/2013,"03/27/2013"
"Drugs",61918,"Ongoing","Hospira Inc.","Lake Forest","IL","US","Voluntary: Firm Initiated","Letter","Nationwide Puerto Rico, U.S. Virgin Island, Libya, Saudi Arabia","D-619-2013","Class II","0.9% Sodium Chloride Injection, USP, a) 50 mL (NDC 0409-7984-13), b) 50 mL (NDC 0409-7984-36), c) 100 mL (0409-7984-37), Rx Only, Hospira, Inc., Lake Forest, IL 60045","Lot #: a) 11-085-JT, Exp 11/13; b) 06-111-JT, Exp 12/12, c) 93-030-JT, 14-044-JT, Exp 9/12",,"2,933,936 units","Lack of Assurance of Sterility: Hospira, Inc is voluntarily recalling the products due to possible leaking bags.",5/4/2012,"05/04/2012",7/3/2013,"07/03/2013"
"Drugs",61918,"Ongoing","Hospira Inc.","Lake Forest","IL","US","Voluntary: Firm Initiated","Letter","Nationwide Puerto Rico, U.S. Virgin Island, Libya, Saudi Arabia","D-618-2013","Class II","1.5% Glycine Irrigation, USP, 3000 mL, Rx Only, Hospira, Inc., Lake Forest, IL 60045 NDC 0409-7974-08","Lot #: 95-057-JT, Exp 11/12",,"40,988 units","Lack of Assurance of Sterility: Hospira, Inc is voluntarily recalling the products due to possible leaking bags.",5/4/2012,"05/04/2012",7/3/2013,"07/03/2013"
"Drugs",61918,"Ongoing","Hospira Inc.","Lake Forest","IL","US","Voluntary: Firm Initiated","Letter","Nationwide Puerto Rico, U.S. Virgin Island, Libya, Saudi Arabia","D-612-2013","Class II","70% Dextrose Injection USP, 2000 mL, Rx Only, by Hospira, Inc., Lake Forest, IL 60045, NDC 0409-7120-07","Lot #: 13-041-JT, Exp 1/14",,"14,706 units","Lack of Assurance of Sterility: Hospira, Inc is voluntarily recalling the products due to possible leaking bags.",5/4/2012,"05/04/2012",7/3/2013,"07/03/2013"
"Drugs",61918,"Ongoing","Hospira Inc.","Lake Forest","IL","US","Voluntary: Firm Initiated","Letter","Nationwide Puerto Rico, U.S. Virgin Island, Libya, Saudi Arabia","D-614-2013","Class II","5% Dextrose Injection USP, a) 250 mL (NDC 0409-7922-02), b) 500 mL (NDC 0409-7922-30), by Hospira, Inc., Lake Forest, IL 60045","Lot #: a) 01-201-JT, Exp 7/12; b) Lot 91-054-JT, Exp 7/12",,"267,288 units","Lack of Assurance of Sterility: Hospira, Inc is voluntarily recalling the products due to possible leaking bags.",5/4/2012,"05/04/2012",7/3/2013,"07/03/2013"
"Drugs",61918,"Ongoing","Hospira Inc.","Lake Forest","IL","US","Voluntary: Firm Initiated","Letter","Nationwide Puerto Rico, U.S. Virgin Island, Libya, Saudi Arabia","D-611-2013","Class II","0.9% Sodium Chloride Injection, USP, Polyolefin Flexible Container, a) 500 mL (NDC 0409-7983-30), b) 1000 mL (NDC 0409-7983-48), c) 250 mL (NDC 0409-7983-02), d) 150 mL (NDC 0409-7983-61), Rx Only, by Hospira, Inc., Lake Forest, IL 60045","Lot #: a) 89-135-JT, 04-224-JT, 07-138-JT, Exp 4/13, 08-160-JT Exp. 8/13 ; b) 08-163-JT, 90-036-JT, 02-048-JT, Exp 2/13; c) 93-102-JT, 11-063-JT, Exp 9/12; d) 93-096-JT, Exp 11/12",,"2,137,660 units","Lack of Assurance of Sterility: Hospira, Inc is voluntarily recalling the products due to possible leaking bags.",5/4/2012,"05/04/2012",7/3/2013,"07/03/2013"
"Drugs",61918,"Ongoing","Hospira Inc.","Lake Forest","IL","US","Voluntary: Firm Initiated","Letter","Nationwide Puerto Rico, U.S. Virgin Island, Libya, Saudi Arabia","D-615-2013","Class II","5% Dextrose and 0.45% Sodium Chloride Injection, USP, 1000 mL VisIV Container, Hospira, Inc., Lake Forest, IL 60045, NDC 0409-7926-48","Lot #: 11-161-JT, Exp 11/13",,"74,256 units","Lack of Assurance of Sterility: Hospira, Inc is voluntarily recalling the products due to possible leaking bags.",5/4/2012,"05/04/2012",7/3/2013,"07/03/2013"
"Drugs",61918,"Ongoing","Hospira Inc.","Lake Forest","IL","US","Voluntary: Firm Initiated","Letter","Nationwide Puerto Rico, U.S. Virgin Island, Libya, Saudi Arabia","D-616-2013","Class II","20% Dextrose Injection, USP, a) 500 mL in 1000 mL Partial-Fill Container (NDC 0409-7935-19), b) 500 mL VisIV Container (NDC 0409-7953-30), c) 1000 mL VisIV Container, (NDC 0409-7953-48), Rx Only, Hospira, Inc., Lake Forest, IL 60045","Lot #: a) 09-183-JT, Exp 3/13; b) 01-081-JT, Exp 7/12; c) 07-078-JT, 91-083-JT, Exp 7/12",,"216,396 units","Lack of Assurance of Sterility: Hospira, Inc is voluntarily recalling the products due to possible leaking bags.",5/4/2012,"05/04/2012",7/3/2013,"07/03/2013"
"Drugs",61918,"Ongoing","Hospira Inc.","Lake Forest","IL","US","Voluntary: Firm Initiated","Letter","Nationwide Puerto Rico, U.S. Virgin Island, Libya, Saudi Arabia","D-613-2013","Class II","0.45% Sodium Chloride Injection, USP, Rx Only, 250 mL, by Hospira, Inc., Lake Forest, IL 60045, NDC 0409-7132-02","Lot #: 93-153-JT, Exp 9/12",,"136,584 units","Lack of Assurance of Sterility: Hospira, Inc is voluntarily recalling the products due to possible leaking bags.",5/4/2012,"05/04/2012",7/3/2013,"07/03/2013"
"Drugs",61918,"Ongoing","Hospira Inc.","Lake Forest","IL","US","Voluntary: Firm Initiated","Letter","Nationwide Puerto Rico, U.S. Virgin Island, Libya, Saudi Arabia","D-617-2013","Class II","0.9% Sodium Chloride Irrigation, USP, 3000 mL, Rx Only, Hospira, Inc., Lake Forest, IL 60045, NDC 0409-7972-08","Lots #: 04-151-JT, 06-040-JT, Exp 4/13",,"98,084 units","Lack of Assurance of Sterility: Hospira, Inc is voluntarily recalling the products due to possible leaking bags.",5/4/2012,"05/04/2012",7/3/2013,"07/03/2013"
"Devices",62121,"Ongoing","Maquet Cardiovascular, LLC","Wayne","NJ","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution - USA including ID and Fl and Internationally to United Arab Emirates, France, Luxembourg, Poland, Spain, Sweden, Germany, Italy, Netherlands, Republic of China, Spain, Sweden, and Thailand","Z-0662-2013","Class II","CARDIOSAVE Intra-Aortic Balloon Pump An electromechanical system used to inflate and deflate intra-aortic balloons. It provide temporary support to the left ventricle via the principle of counterpulsation.","510K K112372 Device Listing Number D132687 US Customer IABPs CA202159K1 CA202167K1 CA203492L1 CA203494L1 International Customer IABPs CA203486L1 CA202155K1 CA202161K1 CA203487L1 CA203490L1 CA203507L1 CA204330L1 CA204328L1 CA203505L1 International Company Owned IABPs CA204327L1 CA202150K1 CA203506L1 CA204324L1 CA204326L1 CA202163K1 CA202169K! CA203497L1 CA203498L1 CA203496L1 CA203503L1 CA203488L1 CA203493L1 CA203508L1 CA204337L1 CA203502L1",".","29 units (total)","In the Cardiosave Intra-aortic Balloon Pump, there is a possibility that the coiled cord assembly, a prominent connector cord between the Cardiosave IABP housing and the dual display head which secured atop the IABP may fail as a result of mishandling.",3/27/2012,"03/27/2012",1/16/2013,"01/16/2013"
"Drugs",62237,"Ongoing","James G. Cole, Inc.","Hood River","OR","US","Voluntary: Firm Initiated","E-Mail","Product was distributed nationwide and Canada","D-129-2013","Class II","I-C Drops, Eye Cleansing Agent, 15 ml ASN/Maxam P.O. Box 1277 Hood River, OR 97031","N/A",".","253 bottles","Lack of Assurance of Sterility: The product is being recalled because the product label does not state sterile in accordance with 21 CFR Part 200.50(a)(1), Ophthalmic Preparations and Dispensers, and it is not in compliance with 21 CFR Part 349, Ophthalmic Drug Products for Over-The-Counter Use.",8/28/2012,"08/28/2012",1/23/2013,"01/23/2013"
"Devices",62334,"Ongoing","Hill-Rom, Inc.","Batesville","IN","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution: USA (nationwide) including states of: AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, WA, WI, WV, and WY; and CANADA LOCATIONS: AB, BC, MB, NB, NS, ON, and SK.","Z-0872-2013","Class II","Liko Overhead Rail System Product Usage - The Overhead Rail System allows overhead lifts to be mounted to the ceiling allowing versatility for use in lifting situations. It can be used with different Liko ceiling lifts.","The Liko Overhead Rail System components are not serialized and have been distributed since the early 1980's to the present.",".","3816 in total","Liko/Hill-Rom to date has received two reports from facilities alleging that the overhead rail system has failed to the extent that the overhead rails have fallen down while in use in high humidity (swimming pool) areas. Analysis of the incidents suggest that the components (hardware) used to secure the rail to the ceiling had corroded and may be unsuitable for environments with an atmosphere containing chlorine.",10/31/2012,"10/31/2012",2/27/2013,"02/27/2013"
"Biologics",62378,"Terminated","United States Blood Bank, Inc.","Miami","FL","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","TX","B-1168-13","Class II","Red Blood Cells Leukocytes Reduced","W223212445216",".","1 unit","Blood product, labeled as leukoreduced but failed to meet QC levels for White Blood Cell counts, was distributed.",5/3/2012,"05/03/2012",7/10/2013,"07/10/2013"
"Devices",62413,"Ongoing","Hill-Rom, Inc.","Batesville","IN","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution -- US (nationwide) including the states of AR, AZ, CA, CO, FL, GA, HI, IA, IL, IN, KS, KY, MA, ME, MI, MN, MO, MS, NC, NE, NJ, NM, NV, NY, OK, OR, PA, TN, TX, UT, WA, WV, and WY., and the country Canada, We have not yet defined our European or International facilities at this time.","Z-0622-2013","Class II","Liko Standard Slingbar 450. The Standard Slingbar 450 is a versatile sling bar which can be used for most lifting situations. It can be used with different Liko ceiling and mobile lifts.","The Liko Standard Slingbar 450 accessory has been supplied under multiple product numbers and combined with the sale of mobile lifts. The Standard Slingbar 450 is not serialized and has been distributed between January 1980 and the present. Here are the different Product Numbers in which the Slingbar has been shipped under: Standard Slingbar 450: 20090029, 20190024, 20190041, 31190015, 31290017, 31290043, 3156001, 3156003, 3156007, 3156014, 3156016, 31590043, and 5019013. Packaged with Golvo up to April of 2005: 2000001, 2000003, 2000005, 2000006, 2000007, 2000008, 2000009, 2000009CH, 2000009D, 2000009DK, 2000009EU, 2000009F, 2000009FIN, 2000009J, 2000009N, 2000009NL, 2000009UK, 2000009U5, 2000010, 20000100, 20000100K, 2000010EU, 2000010F, 2000010FIN, 2000010H, 2000010J, 2000010N, 2000010NL, 2000010UK, 200001OU5, 2000050, 2000051, 2000061, IN8000, and IN8061. Packaged with Viking up to December of 2004: 2040003, 2040003L, 2040004, 2040005, 2040006, 2040007, 2040013, 2040014, 2040015, 2040033, 2040034, and 2040035. Packaged with LikoLight up to December of 2004: 2030001 and 2030001H. Packaged with Uno lifts up to present: 2010001, 2010002, 2010003, 2010003D, 2010003EU, 2010003F, 2010003H, 2010003N, 2010003UK, 2010003US, 2010004, 2010004D, 2010004EU, 2010004F, 2010004H, 2010004N, 2010004UK, 2010004US, 2010005, 20100050, 2010005EU, 2010005F, 2010005N, 2010005UK, 2010005U5, 2010011, 2010012, 5E2010004, and 5E2010011. Packaged with Caroli lifts up to present: 5011001.",".","261 units","Liko/Hill-Rom has received reports from facilities which indicate that serious injuries have been received related to the Standard Sling bar 450. There have been 6 complaints of injury related to the product over the past 32 years (6 out of 838,687,856 estimated patient uses). One of the injuries was associated with a patient during use, four injuries occurred when the slingbar was not in use where someone tripped and fell onto the unit, and one where a child was playing on a lift and was injured when they tried to jump from the lift.",12/6/2012,"12/06/2012",1/9/2013,"01/09/2013"
"Drugs",62454,"Ongoing","Mylan LLC.","Caguas","PR","US","Voluntary: Firm Initiated",,"Natiowide.","D-066-2013","Class II","Mylan, Tacrolimus Capsules 0.5 mg, 100 count bottle, Rx only, Mylan Pharmaceuticals Inc., Morgantown, WV 26505 NDC 0378-2045-01","Lots: 3027684 Exp. 5/13, 3027688 Exp. 6/13 & 2002157 Exp. 9/12",".","15181 bottles. ","Failed USP Content Uniformity Requirements: OOS result reported on retained samples.",6/29/2012,"06/29/2012",1/9/2013,"01/09/2013"
"Food",62529,"Ongoing","Combs Produce","Dallas","TX","US","Voluntary: Firm Initiated","Telephone","TX, OK, CO","F-1897-2013","Class II","Round Fresh Tomatoes sold in bulk boxes, 20 lbs","X0198972 and X0198992",,"8075 lbs","The product has the potential to be contaminated with E. coli 0157: H7.",7/6/2012,"07/06/2012",9/25/2013,"09/25/2013"
"Devices",62624,"Ongoing","Laserworld Usa Inc","New York","NY","US","Voluntary: Firm Initiated","Letter","US Distribution including the states of CA, CO, FL, KS and PA.","Z-1538-2013","Class II","Laserworld RGB & Piko Nano RGB Models All models are laser light show projectors, and will be used as such. ","All projectors distributed between 2008 and 2012, including, but not limited to, the Proline Series AG, Revolution Series AG, Club Series AG, Clus Series, Pure Light Series, and Revolution Series AG ",,"Total distribution of more than 500 units between July1, 2008, and June 30, 2012","A potential lack of certification, and/or missing laser certification, laser safety warning and administrative labels, and potentially incomplete Performance Feature set and incomplete User Information were discovered.",7/19/2012,"07/19/2012",9/25/2013,"09/25/2013"
"Drugs",62625,"Ongoing","Fougera Pharmaceuticals Inc.","Melville","NY","US","Voluntary: Firm Initiated","Letter","Nationwide","D-241-2013","Class III","Fougera Ketoconazole Cream 2%, 15g tube, Rx only, Labeled with E. Fougera & Co., a division of Fougera Pharmaceuticals Inc., Melville, New York 11747, NDC 0168-0099-15","Lot #: 835H, Exp 07/12",".","60,210 units","Failed Impurities/Degradation Specifications: Ketoconazole Cream 2% is the subject of a voluntary drug recall by Fougera due to an Out Of Specification result for an unknown degradant product",7/18/2012,"07/18/2012",4/10/2013,"04/10/2013"
"Drugs",62664,"Ongoing","Lloyd Inc. of Iowa","Shenandoah","IA","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Distribution was nationwide and to Puerto Rico. There was no foreign, military, or government distribution.","D-103-2013","Class II","Levothroid (levothyroxine sodium tablets, USP), 75 mcg., 100-count bottles, Rx only, NDC 0456-1322-01, Manufactured for Forest Pharmaceuticals, Inc., Subsidiary of Forest Laboratories, Inc., St. Louis, MO, by Lloyd Pharmaceutical, Shenandoah, IA.","Lot 1094098, exp. date 9/2012",".","16,548/100-tablet bottles","Subpotent; 9-month stability interval",7/25/2012,"07/25/2012",1/2/2013,"01/02/2013"
"Drugs",62664,"Ongoing","Lloyd Inc. of Iowa","Shenandoah","IA","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Distribution was nationwide and to Puerto Rico. There was no foreign, military, or government distribution.","D-100-2013","Class II","Thyro-Tab 0.050 mg., packaged in 150,000-tablet bulk drums for repackaging, RX. The firm name on the label is Lloyd Pharmaceutical, Shenandoah, IA.","Lot HB23111 and HC23111",".","3,789,426/50-mcg. tablets","Subpotent; 9-month stability interval",7/25/2012,"07/25/2012",1/2/2013,"01/02/2013"
"Drugs",62664,"Ongoing","Lloyd Inc. of Iowa","Shenandoah","IA","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Distribution was nationwide and to Puerto Rico. There was no foreign, military, or government distribution.","D-101-2013","Class II","Levothroid (levothyroxine sodium tablets, USP), 50 mcg., 100-count bottles, Rx only, NDC 0456-1321-01, Manufactured for Forest Pharmaceuticals, Inc., Subsidiary of Forest Laboratories, Inc., St. Louis, MO, by Lloyd Pharmaceutical, Shenandoah, IA.","Lot 1093992 and 1094095, exp. date 9/2012",".","37,441/100-tablet bottles","Subpotent; 9-month stability interval",7/25/2012,"07/25/2012",1/2/2013,"01/02/2013"
"Drugs",62664,"Ongoing","Lloyd Inc. of Iowa","Shenandoah","IA","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Distribution was nationwide and to Puerto Rico. There was no foreign, military, or government distribution.","D-102-2013","Class II","Thyro-Tab 0.075 mg., packaged in 150,000-tablet bulk drums for repackaging, RX. The firm name on the label is Lloyd Pharmaceutical, Shenandoah, IA","Lot HF23111",".","1,924,133/75-mcg. tablets","Subpotent; 9-month stability interval",7/25/2012,"07/25/2012",1/2/2013,"01/02/2013"
"Biologics",62670,"Ongoing","Genzyme Corporation","Framingham","MA","US","Voluntary: Firm Initiated","Letter","Nationwide","B-0964-13","Class II","Genzyme Thymoglobulin [Anti-thymocyte Globulin (Rabbit)], 25 mg, for intravenous use only, Rx. NDC 58468-0080-01","C0072C01 Feb 2013;C0062C01 Dec 2012; C0086C01 May 2013; C0094C01 Jul 2013; C0096C01 Aug 2013; C0098C01 Aug 2013; C0098C02 Aug 2013; C0098C03 Aug 2013; C0100C01 Aug-2013",,"9 units","Anti-Thymocyte Globulin (Rabbit) 25 mg, with an OOS assay result on the molecular size distribution stability test, was distributed. ",7/26/2012,"07/26/2012",3/6/2013,"03/06/2013"
"Food",62716,"Ongoing","Christian Cheese, LLC","Kingfisher","OK","US","Voluntary: Firm Initiated","Telephone","CO and OK","F-1652-2013","Class II","Christian Cheese Horseradish Cheddar Cheese Made in Kingfisher, Oklahoma (405-375-6711) Ingredients: Pasteurized Milk, Culture, Vegetable Rennet, Salt, and Horseradish. 1 unit weighing approximately 0.6 lbs and plastic vacuum packed in plastic. 1 case is approximately 32 units weighing approximately 0.60 lbs each.","No codes are used at the facility. All product made approximately on June 7, 2012.",".",,"Undeclared Soy lecithin and Soybean Oil",6/14/2012,"06/14/2012",7/17/2013,"07/17/2013"
"Food",62716,"Ongoing","Christian Cheese, LLC","Kingfisher","OK","US","Voluntary: Firm Initiated","Telephone","CO and OK","F-1651-2013","Class II","Christian Cheese Blackberry Wine Cheese Made in Kingfisher, Oklahoma (405-375-6711) Ingredients: Pasteurized Milk, Culture, Vegetable Rennet, Salt, Blackberry Wine. 1 unit weighing approximately 0.6 lbs and plastic vacuum packed in plastic. 1 case is approximately 32 units weighing approximately 0.60 lbs each.","No codes are used at the facility. All product made approximately on June 7, 2012.",".",,"Undeclared sulfites",6/14/2012,"06/14/2012",7/17/2013,"07/17/2013"
"Food",62716,"Ongoing","Christian Cheese, LLC","Kingfisher","OK","US","Voluntary: Firm Initiated","Telephone","CO and OK","F-1648-2013","Class II","Christian Cheese Vegetable Cheddar Made in Kingfisher, Oklahoma (405-375-6711) Ingredients: Pasteurized Milk, Culture, Rennet, Salt, Onion, Garlic, Basil, Red Bell Pepper, Black Pepper, Tomato, Vinegar, Parsley, Ginger, and Rosemary. 1 unit weighing approximately 0.6 lbs and plastic vacuum packed in plastic. 1 case is approximately 32 units weighing approximately 0.60 lbs each.","No codes are used at the facility. All product made approximately on June 7, 2012.",".","Approximately 15-16 units","Undeclared Soy lecithin and Soybean Oil ",6/14/2012,"06/14/2012",7/17/2013,"07/17/2013"
"Food",62716,"Ongoing","Christian Cheese, LLC","Kingfisher","OK","US","Voluntary: Firm Initiated","Telephone","CO and OK","F-1647-2013","Class II","Christian Cheese Ranch Cheddar Made in Kingfisher, Oklahoma (405-375-6711) Ingredients: Pasteurized Milk, Culture, Rennet, Salt, and Ranch Dressing. 1 unit weighing approximately 0.6 lbs and plastic vacuum packed in plastic. 1 case is approximately 32 units weighing approximately 0.60 lbs each.","No codes are used at the facility. All product made approximately on June 7, 2012.",".","Approximately 15-16 units","Undeclared Soy lecithin ",6/14/2012,"06/14/2012",7/17/2013,"07/17/2013"
"Food",62716,"Ongoing","Christian Cheese, LLC","Kingfisher","OK","US","Voluntary: Firm Initiated","Telephone","CO and OK","F-1649-2013","Class II","Christian Cheese Ranch Bacon Cheddar Made in Kingfisher, Oklahoma (405-375-6711) Ingredients: Pasteurized Milk, Culture, Rennet, Salt, Ranch Dressing and Bacon Bits. 1 unit weighing approximately 0.6 lbs and plastic vacuum packed in plastic. 1 case is approximately 32 units weighing approximately 0.60 lbs each.","No codes are used at the facility. All product made approximately on June 7, 2012.",".","Approximately 15-16 units","undeclared Soy lecithin, Soybean Oil, and sulfites",6/14/2012,"06/14/2012",7/17/2013,"07/17/2013"
"Food",62716,"Ongoing","Christian Cheese, LLC","Kingfisher","OK","US","Voluntary: Firm Initiated","Telephone","CO and OK","F-1650-2013","Class II","Christian Cheese Sun-Dried tomato Cheddar Made in Kingfisher, Oklahoma (405-375-6711) Ingredients: Pasteurized Milk, Culture, Vegetable Rennet, Sun-Dried Tomato and Salt. 1 unit weighing approximately 0.6 lbs and plastic vacuum packed in plastic. 1 case is approximately 32 units weighing approximately 0.60 lbs each.","No codes are used at the facility. All product made approximately on June 7, 2012.",".","Approximately 15-16 units","Undeclared Sulfites ",6/14/2012,"06/14/2012",7/17/2013,"07/17/2013"
"Devices",62719,"Ongoing","DePuy Spine, Inc.","Raynham","MA","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution - USA (nationwide) and internationally to Belgium, Egypt, Ireland, Italy, Portugal, and the UK.","Z-0685-2013","Class II","DePuy Spine EXPEDIUM Offset Torque Wrench Product Code 2797-29-510 The device is intended for use during the final tightening of an Expedium Offset Spinal Construct.","All lots",".","140 units","A component within the handle of the Expedium Offset Torque Wrench is prematurely wearing, potentially resulting in the instrument recording torque values outside of the specification.",7/24/2012,"07/24/2012",1/23/2013,"01/23/2013"
"Food",62763,"Ongoing","American Beverage Corp","Verona","PA","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Nationwide.","F-0207-2014","Class II","Big Hug Lemon Lime Fruit Drink in a 16 oz plastic bottle with a sports cap, American Beverage Corp., Verona PA. ","Products bearing a ''best buy'' or ''expiration date'' earlier than 09/24/12 ONLY: UPC- 074806001653 ",,"250,000 cases-total for all products","There is a possibility that a part of the nozzle cap of the bottle can become dislodged through abuse (i.e. excessive chewing) then possibly ingested, and posing a potential health/safety hazard. The cap in question is no longer used by ABC and was last produced in September of 2011. Firm does not anticipate finding any impacted product in the market.",5/15/2012,"05/15/2012",11/27/2013,"11/27/2013"
"Food",62763,"Ongoing","American Beverage Corp","Verona","PA","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Nationwide.","F-0205-2014","Class II","Big Hug Fruit Barrel Kiwi Strawberry, in a 16 oz plastic bottle with a sports cap, American Beverage Corp., Verona PA. ","Products bearing a ''best buy'' or ''expiration date'' earlier than 09/24/12 ONLY: UPC- 074806001622 ",,"250,000 cases-total for all products","There is a possibility that a part of the nozzle cap of the bottle can become dislodged through abuse (i.e. excessive chewing) then possibly ingested, and posing a potential health/safety hazard. The cap in question is no longer used by ABC and was last produced in September of 2011. Firm does not anticipate finding any impacted product in the market.",5/15/2012,"05/15/2012",11/27/2013,"11/27/2013"
"Food",62763,"Ongoing","American Beverage Corp","Verona","PA","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Nationwide.","F-0189-2014","Class II","Big Hug, Fruit Barrel Orange in a plastic 16 oz bottle with a sports cap, American Beverage Corp., Verona, PA. ","Products bearing a ''best buy'' or ''expiration date'' earlier than 09/24/12 ONLY: UPCs - 074806001585 ",,"250,000 cases-total for all products","There is a possibility that a part of the nozzle cap of the bottle can become dislodged through abuse (i.e. excessive chewing), and then possibly ingested, posing a potential health/safety hazard. The cap in question is no longer used by ABC and was last produced in September of 2011. Firm does not anticipate finding any impacted product in the market.",5/15/2012,"05/15/2012",11/27/2013,"11/27/2013"
"Food",62763,"Ongoing","American Beverage Corp","Verona","PA","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Nationwide.","F-0198-2014","Class II","Big Juicy Blue Raspberry Drink in 10 oz plastic bottle with a sports cap, American Beverage Corporation, Verona PA. ","Products bearing a ''best buy'' or ''expiration date'' earlier than 09/24/12 ONLY.",,"250,000 cases-total for all products","There is a possibility that a part of the nozzle cap of the bottle can become dislodged through abuse (i.e. excessive chewing) then possibly ingested, and posing a potential health/safety hazard. The cap in question is no longer used by ABC and was last produced in September of 2011. Firm does not anticipate finding any impacted product in the market.",5/15/2012,"05/15/2012",11/27/2013,"11/27/2013"
"Food",62763,"Ongoing","American Beverage Corp","Verona","PA","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Nationwide.","F-0200-2014","Class II","Big Juicy Orange Drink in 10 oz plastic bottle with a sports cap, American Beverage Corporation, Verona PA. ","Products bearing a ''best buy'' or ''expiration date'' earlier than 09/24/12 ONLY, UPC code 074806170007.",,"250,000 cases-total for all products","There is a possibility that a part of the nozzle cap of the bottle can become dislodged through abuse (i.e. excessive chewing) then possibly ingested, and posing a potential health/safety hazard. The cap in question is no longer used by ABC and was last produced in September of 2011. Firm does not anticipate finding any impacted product in the market.",5/15/2012,"05/15/2012",11/27/2013,"11/27/2013"
"Food",62763,"Ongoing","American Beverage Corp","Verona","PA","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Nationwide.","F-0208-2014","Class II","Big Hug Fruit Barrel Blue Raspberry in a 16 oz plastic bottle with a sports cap, American Beverage Corp., Verona PA. ","Products bearing a ''best buy'' or ''expiration date'' earlier than 09/24/12 ONLY: UPC- 074806001615 ",,"250,000 cases-total for all products","There is a possibility that a part of the nozzle cap of the bottle can become dislodged through abuse (i.e. excessive chewing) then possibly ingested, and posing a potential health/safety hazard. The cap in question is no longer used by ABC and was last produced in September of 2011. Firm does not anticipate finding any impacted product in the market.",5/15/2012,"05/15/2012",11/27/2013,"11/27/2013"
"Food",62763,"Ongoing","American Beverage Corp","Verona","PA","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Nationwide.","F-0210-2014","Class II","Big Burst Lemon Lime Drink, in a 16 oz PET plastic bottle with a sports cap, American Beverage Corp., Verona PA. ","Products bearing a ''best buy'' or ''expiration date'' earlier than 09/24/12 ONLY: UPC - 073798001054",,"250,000 cases-total for all products","There is a possibility that a part of the nozzle cap of the bottle can become dislodged through abuse (i.e. excessive chewing) then possibly ingested, and posing a potential health/safety hazard. The cap in question is no longer used by ABC and was last produced in September of 2011. Firm does not anticipate finding any impacted product in the market.",5/15/2012,"05/15/2012",11/27/2013,"11/27/2013"
"Food",62763,"Ongoing","American Beverage Corp","Verona","PA","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Nationwide.","F-0192-2014","Class II","Guzzler Island Punch 20 fl. oz. PET plastic bottle with a sports cap, American Beverage Corporation, Verona PA.","The following product bearing a ''best buy'' or ''expiration date'' earlier than 09/24/12 ONLY: Flavor and UPC code: Island Punch, 018397000015",,"250,000 cases-total for all products","There is a possibility that a part of the nozzle cap of the bottle can become dislodged through abuse (i.e. excessive chewing) then possibly ingested, and posing a potential health/safety hazard. The cap in question is no longer used by ABC and was last produced in September of 2011. Firm does not anticipate finding any impacted product in the market.",5/15/2012,"05/15/2012",11/27/2013,"11/27/2013"
"Food",62763,"Ongoing","American Beverage Corp","Verona","PA","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Nationwide.","F-0191-2014","Class II","Guzzler Concord Grape 20 fl. oz. PET plastic bottle with a sports cap, American Beverage Corporation, Verona PA. ","The following product bearing a ''best buy'' or ''expiration date'' earlier than 09/24/12 ONLY: Flavor and UPC code: Concord Grape, 018397000039",,"250,000 cases-total for all products","There is a possibility that a part of the nozzle cap of the bottle can become dislodged through abuse (i.e. excessive chewing) then possibly ingested, and posing a potential health/safety hazard. The cap in question is no longer used by ABC and was last produced in September of 2011. Firm does not anticipate finding any impacted product in the market.",5/15/2012,"05/15/2012",11/27/2013,"11/27/2013"
"Food",62763,"Ongoing","American Beverage Corp","Verona","PA","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Nationwide.","F-0195-2014","Class II","Guzzler Alpine Freeze, 20 fl. oz. PET plastic bottle with a sports cap, American Beverage Corporation, Verona PA. ","The following product bearing a ''best buy'' or ''expiration date'' earlier than 09/24/12 ONLY: Flavor and UPC code: Alpine Freeze, 018397000091.",,"250,000 cases-total for all products","There is a possibility that a part of the nozzle cap of the bottle can become dislodged through abuse (i.e. excessive chewing) then possibly ingested, and posing a potential health/safety hazard. The cap in question is no longer used by ABC and was last produced in September of 2011. Firm does not anticipate finding any impacted product in the market.",5/15/2012,"05/15/2012",11/27/2013,"11/27/2013"
"Food",62763,"Ongoing","American Beverage Corp","Verona","PA","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Nationwide.","F-0193-2014","Class II","Guzzler Iced Tea 20 fl. oz. PET plastic bottle with a sports cap, American Beverage Corporation, Verona PA.","The following product bearing a ''best buy'' or ''expiration date'' earlier than 09/24/12 ONLY: Flavorand UPC code: Iced Tea, 018397000077",,"250,000 cases-total for all products","There is a possibility that a part of the nozzle cap of the bottle can become dislodged through abuse (i.e. excessive chewing) then possibly ingested, and posing a potential health/safety hazard. The cap in question is no longer used by ABC and was last produced in September of 2011. Firm does not anticipate finding any impacted product in the market.",5/15/2012,"05/15/2012",11/27/2013,"11/27/2013"
"Food",62763,"Ongoing","American Beverage Corp","Verona","PA","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Nationwide.","F-0201-2014","Class II","Big Juicy Fruit Punch Drink in 10 oz plastic bottle with a sports cap, American Beverage Corporation, Verona PA. ","Products bearing a ''best buy'' or ''expiration date'' earlier than 09/24/12 ONLY, UPC code 074806170021.",,"250,000 cases-total for all products","There is a possibility that a part of the nozzle cap of the bottle can become dislodged through abuse (i.e. excessive chewing) then possibly ingested, and posing a potential health/safety hazard. The cap in question is no longer used by ABC and was last produced in September of 2011. Firm does not anticipate finding any impacted product in the market.",5/15/2012,"05/15/2012",11/27/2013,"11/27/2013"
"Food",62763,"Ongoing","American Beverage Corp","Verona","PA","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Nationwide.","F-0199-2014","Class II","Big Juicy Grape Drink in 10 oz plastic bottle with a sports cap, American Beverage Corporation, Verona PA. ","Products bearing a ''best buy'' or ''expiration date'' earlier than 09/24/12 ONLY, UPC code 074806170014.",,"250,000 cases-total for all products","There is a possibility that a part of the nozzle cap of the bottle can become dislodged through abuse (i.e. excessive chewing) then possibly ingested, and posing a potential health/safety hazard. The cap in question is no longer used by ABC and was last produced in September of 2011. Firm does not anticipate finding any impacted product in the market.",5/15/2012,"05/15/2012",11/27/2013,"11/27/2013"
"Food",62763,"Ongoing","American Beverage Corp","Verona","PA","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Nationwide.","F-0211-2014","Class II","Big Burst Fruit Punch Drink, in a 16 oz PET plastic bottle with a sports cap, American Beverage Corp., Verona PA. ","Products bearing a ''best buy'' or ''expiration date'' earlier than 09/24/12 ONLY: UPC-073798001030",,"250,000 cases-total for all products","There is a possibility that a part of the nozzle cap of the bottle can become dislodged through abuse (i.e. excessive chewing) then possibly ingested, and posing a potential health/safety hazard. The cap in question is no longer used by ABC and was last produced in September of 2011. Firm does not anticipate finding any impacted product in the market.",5/15/2012,"05/15/2012",11/27/2013,"11/27/2013"
"Food",62763,"Ongoing","American Beverage Corp","Verona","PA","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Nationwide.","F-0190-2014","Class II","Guzzler Lemonade 20 fl. oz. PET plastic bottle with a sports cap, American Beverage Corporation, Verona PA.","The following product bearing a ''best buy'' or ''expiration date'' earlier than 09/24/12 ONLY: Flavor and UPC code: Lemonade, 018397000060",,"250,000 cases-total for all products","There is a possibility that a part of the nozzle cap of the bottle can become dislodged through abuse (i.e. excessive chewing) then possibly ingested, and posing a potential health/safety hazard. The cap in question is no longer used by ABC and was last produced in September of 2011. Firm does not anticipate finding any impacted product in the market.",5/15/2012,"05/15/2012",11/27/2013,"11/27/2013"
"Food",62763,"Ongoing","American Beverage Corp","Verona","PA","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Nationwide.","F-0213-2014","Class II","Big Burst Kiwi Strawberry Drink in a 16 oz PET plastic bottle with a sports cap, American Beverage Corp., Verona PA. ","Products bearing a ''best buy'' or ''expiration date'' earlier than 09/24/12 ONLY: UPC-073798001207.",,"250,000 cases-total for all products","There is a possibility that a part of the nozzle cap of the bottle can become dislodged through abuse (i.e. excessive chewing) then possibly ingested, and posing a potential health/safety hazard. The cap in question is no longer used by ABC and was last produced in September of 2011. Firm does not anticipate finding any impacted product in the market.",5/15/2012,"05/15/2012",11/27/2013,"11/27/2013"
"Food",62763,"Ongoing","American Beverage Corp","Verona","PA","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Nationwide.","F-0214-2014","Class II","Big Burst Citrus Punch Drink in a 16 oz PET plastic bottle with a sports cap, American Beverage Corp., Verona PA. ","Products bearing a ''best buy'' or ''expiration date'' earlier than 09/24/12 ONLY: UPC -073798001108",,"250,000 cases-total for all products","There is a possibility that a part of the nozzle cap of the bottle can become dislodged through abuse (i.e. excessive chewing) then possibly ingested, and posing a potential health/safety hazard. The cap in question is no longer used by ABC and was last produced in September of 2011. Firm does not anticipate finding any impacted product in the market.",5/15/2012,"05/15/2012",11/27/2013,"11/27/2013"
"Food",62763,"Ongoing","American Beverage Corp","Verona","PA","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Nationwide.","F-0206-2014","Class II","Big Hug Lemonade Fruit Drink in a 16 oz plastic bottle with a sports cap, American Beverage Corp., Verona PA. ","Products bearing a ''best buy'' or ''expiration date'' earlier than 09/24/12 ONLY: UPC- 074806001639 ",,"250,000 cases-total for all products","There is a possibility that a part of the nozzle cap of the bottle can become dislodged through abuse (i.e. excessive chewing) then possibly ingested, and posing a potential health/safety hazard. The cap in question is no longer used by ABC and was last produced in September of 2011. Firm does not anticipate finding any impacted product in the market.",5/15/2012,"05/15/2012",11/27/2013,"11/27/2013"
"Food",62763,"Ongoing","American Beverage Corp","Verona","PA","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Nationwide.","F-0194-2014","Class II","Guzzler Kiwi-Strawberry, 20 fl. oz. PET plastic bottle with a sports cap, American Beverage Corporation, Verona PA. ","The following product bearing a ''best buy'' or ''expiration date'' earlier than 09/24/12 ONLY: Flavor and UPC code: Kiwi-Strawberry, 018397000022",,"250,000 cases-total for all products","There is a possibility that a part of the nozzle cap of the bottle can become dislodged through abuse (i.e. excessive chewing) then possibly ingested, and posing a potential health/safety hazard. The cap in question is no longer used by ABC and was last produced in September of 2011. Firm does not anticipate finding any impacted product in the market.",5/15/2012,"05/15/2012",11/27/2013,"11/27/2013"
"Food",62763,"Ongoing","American Beverage Corp","Verona","PA","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Nationwide.","F-0204-2014","Class II","Big Hug Fruit Barrel Citrus in a 16 oz plastic bottle with a sports cap, American Beverage Corp., Verona PA. ","Products bearing a ''best buy'' or ''expiration date'' earlier than 09/24/12 ONLY: UPC- 074806001691. ",,"250,000 cases-total for all products","There is a possibility that a part of the nozzle cap of the bottle can become dislodged through abuse (i.e. excessive chewing) then possibly ingested, and posing a potential health/safety hazard. The cap in question is no longer used by ABC and was last produced in September of 2011. Firm does not anticipate finding any impacted product in the market.",5/15/2012,"05/15/2012",11/27/2013,"11/27/2013"
"Food",62763,"Ongoing","American Beverage Corp","Verona","PA","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Nationwide.","F-0196-2014","Class II","Guzzler Orchard Chill, 20 fl. oz. PET plastic bottle with a sports cap, American Beverage Corporation, Verona PA. ","The following product bearing a ''best buy'' or ''expiration date'' earlier than 09/24/12 ONLY: Flavor and UPC code: Orchard Chill, 018397000107",,"250,000 cases-total for all products","There is a possibility that a part of the nozzle cap of the bottle can become dislodged through abuse (i.e. excessive chewing) then possibly ingested, and posing a potential health/safety hazard. The cap in question is no longer used by ABC and was last produced in September of 2011. Firm does not anticipate finding any impacted product in the market.",5/15/2012,"05/15/2012",11/27/2013,"11/27/2013"
"Food",62763,"Ongoing","American Beverage Corp","Verona","PA","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Nationwide.","F-0203-2014","Class II","Big Hug Fruit Barrel Fruit Punch in a 16 oz plastic bottle with a sports cap, American Beverage Corp., Verona PA. ","Products bearing a ''best buy'' or ''expiration date'' earlier than 09/24/12 ONLY: UPC- 074806001608 ",,"250,000 cases-total for all products","There is a possibility that a part of the nozzle cap of the bottle can become dislodged through abuse (i.e. excessive chewing) then possibly ingested, and posing a potential health/safety hazard. The cap in question is no longer used by ABC and was last produced in September of 2011. Firm does not anticipate finding any impacted product in the market.",5/15/2012,"05/15/2012",11/27/2013,"11/27/2013"
"Food",62763,"Ongoing","American Beverage Corp","Verona","PA","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Nationwide.","F-0209-2014","Class II","Big Burst Grape Drink in a 16 oz PET plastic bottle with a sports cap, American Beverage Corp., Verona PA. ","Products bearing a ''best buy'' or ''expiration date'' earlier than 09/24/12 ONLY: UPC -073798001023",,"250,000 cases-total for all products","There is a possibility that a part of the nozzle cap of the bottle can become dislodged through abuse (i.e. excessive chewing) then possibly ingested, and posing a potential health/safety hazard. The cap in question is no longer used by ABC and was last produced in September of 2011. Firm does not anticipate finding any impacted product in the market.",5/15/2012,"05/15/2012",11/27/2013,"11/27/2013"
"Food",62763,"Ongoing","American Beverage Corp","Verona","PA","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Nationwide.","F-0188-2014","Class II","Big Burst Orange Drink in a 16 oz PET bottle with a sports cap, American Beverage Corp., Verona, PA. ","Products bearing a ''best buy'' or ''expiration date'' earlier than 09/24/12 ONLY: UPCs - 073798001016",,"250,000 cases-total for all products","There is a possibility that a part of the nozzle cap of the bottle can become dislodged through abuse (i.e. excessive chewing) then possibly ingested, posing a potential health/safety hazard. The cap in question is no longer used by ABC and was last produced in September of 2011. Firm does not anticipate finding any impacted product in the market.",5/15/2012,"05/15/2012",11/27/2013,"11/27/2013"
"Food",62763,"Ongoing","American Beverage Corp","Verona","PA","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Nationwide.","F-0212-2014","Class II","Big Burst Blue Raspberry Drink in a 16 oz PET plastic bottle with a sports cap, American Beverage Corp., Verona PA. ","Products bearing a ''best buy'' or ''expiration date'' earlier than 09/24/12 ONLY: UPC-073798001092",,"250,000 cases-total for all products","There is a possibility that a part of the nozzle cap of the bottle can become dislodged through abuse (i.e. excessive chewing) then possibly ingested, and posing a potential health/safety hazard. The cap in question is no longer used by ABC and was last produced in September of 2011. Firm does not anticipate finding any impacted product in the market.",5/15/2012,"05/15/2012",11/27/2013,"11/27/2013"
"Food",62763,"Ongoing","American Beverage Corp","Verona","PA","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Nationwide.","F-0202-2014","Class II","Big Hug Fruit Barrel Grape in a 16 oz plastic bottle with a sports cap, American Beverage Corp., Verona PA. ","Products bearing a ''best buy'' or ''expiration date'' earlier than 09/24/12 ONLY: UPC- 074806001592 ",,"250,000 cases-total for all products","There is a possibility that a part of the nozzle cap of the bottle can become dislodged through abuse (i.e. excessive chewing) then possibly ingested, and posing a potential health/safety hazard. The cap in question is no longer used by ABC and was last produced in September of 2011. Firm does not anticipate finding any impacted product in the market.",5/15/2012,"05/15/2012",11/27/2013,"11/27/2013"
"Food",62763,"Ongoing","American Beverage Corp","Verona","PA","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Nationwide.","F-0197-2014","Class II","Guzzler Citrus Punch, 20 fl. oz. PET plastic bottle with a sports cap, American Beverage Corporation, Verona PA. ","The following product bearing a ''best buy'' or ''expiration date'' earlier than 09/24/12 ONLY: Flavor and UPC code: Citrus Punch, 018397000138",,"250,000 cases-total for all products","There is a possibility that a part of the nozzle cap of the bottle can become dislodged through abuse (i.e. excessive chewing) then possibly ingested, and posing a potential health/safety hazard. The cap in question is no longer used by ABC and was last produced in September of 2011. Firm does not anticipate finding any impacted product in the market.",5/15/2012,"05/15/2012",11/27/2013,"11/27/2013"
"Devices",62804,"Ongoing","Orthofix, Inc","Lewisville","TX","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution - USA (nationwide) Internationally to Australia, Hong Kong, Saudi Arabia, Korea, Turkey, Greece, Finland, South Africa, Spain, Singapore, Switzerland, Brazil, Germany, France, Japan, Netherlands, New Zealand, Israel, Canada and Mexico. ","Z-0895-2013","Class II","Orthofix ISKD Limb Lengthener Sterile Rx Only, Orthofix Inc. Lewisville, TX 75056. ISKD - Intramedullary Skeletal Kinetic Distractor. The ISKD is intended for limb lengthening of the tibia and femur.","All serial numbers of the following Catalog Numbers:F12-255-305, F12-345-395NS, T12-245-295, F12-255-305NS, F12-345-425, T12-255-305, F12-255-335, F12-345-425NS, T12-255-305NS, F12-255-335NS, T10-215-265, T12-255-335, F12-300-350, T10-255-305, T12-255-335NS, F12-300-350NS, T10-255-335, T12-300-350, F12-300-380, T10-300-350, T12-300-350NS, F12-300-380NS, T12-215-265, T12-300-380, F12-345-395, T12-215-265NS, and T12-300-380NS",,"1224 ISKD Limb Lengtheners","There is a possibility that the ISKD limb lengthener may stop distracting post-operatively during treatment, which may result in premature bone consolidation (limb not achieving the desired length) leading to revision surgery to remove and/or replace the device.",8/6/2012,"08/06/2012",3/6/2013,"03/06/2013"
"Drugs",62836,"Completed","Body Basics Inc","Canoga Park","CA","US","Voluntary: Firm Initiated","Telephone","Nationwide","D-265-2013","Class I","Actra-SX 500 Capsules, Maximum Strength, Energizer, 500 mg, 5 count package, Body Basics, Canoga Park, CA","Lot number 008A, expiration date Dec 2014, UPC code 830733002016",".","30,000 capsules","Marketed without an Approved NDA/ANDA; product contains sildenafil, an active ingredient in a FDA approved product for the treatment of Erectile Dysfunction",12/19/2011,"12/19/2011",4/24/2013,"04/24/2013"
"Biologics",62882,"Terminated","Delta Blood Bank","Stockton","CA","US","Voluntary: Firm Initiated","Letter","Austria","B-1574-13","Class II","Blood and Blood Products for Reprocessing","W128710072059",,"1 unit","Blood products, collected from a donor considered to be at increased risk for variant Creutzfeldt-Jakob Disease (vCJD), were distributed. ",5/30/2012,"05/30/2012",7/31/2013,"07/31/2013"
"Drugs",62908,"Ongoing","Bayer HealthCare Pharmaceuticals Inc.","Lynnwood","WA","US","Voluntary: Firm Initiated","Letter","Nationwide","D-156-2013","Class III","Leukine sargramostim 5 x 500 mcg/mL vial, liquid injection, Sterile Rx only, Mfd by: Bayer HealthCare Pharmaceuticals, LLC Seattle, WA 98101 U.S. Lic. No. 1791 NDC 58468-0181-2","B18511 Exp. 04/12 , B18513 Exp. 05/12, B18515 Exp. 06/12, B18517 Exp. 06/12, B18825 Exp. 10/12, B18831 Exp.12/12",,"138,505 vials","Impurities/Degradation Products: A confirmed out of specification result for Leukine sargramostin lot B18827 occurred at the three month time point.",5/31/2012,"05/31/2012",2/13/2013,"02/13/2013"
"Devices",62943,"Ongoing","Synthes USA HQ, Inc.","West Chester","PA","US","Voluntary: Firm Initiated","Letter","Nationwide Distribution-including Puerto Rico and the states of AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV and WY.","Z-0781-2013","Class II","Synthes(R) Spine Vectra, Vectra-T and Vectra-One Anterior Cervical Plating for Spinal Fusion - 2.5mm Drill Bit, graduated 12mm - 26mm adjustable depth, Part Number 03.613.011. Synthes Vectra System, Synthes Vectra-One System and Synthes Vectra-T System is intended for anterior plate and screw fixation of the cervical spine (C2-C7). ","2.5mm Drill Bit, graduated 12mm - 26mm adjustable depth, Part Number 03.613.011 - Lots 5443576, 5522810, 5537042, 5557902",,"63","Although the reported incidence is low, there is the potential for the drill stop to slip on the drill bit resulting in an adverse event.",8/6/2012,"08/06/2012",2/13/2013,"02/13/2013"
"Devices",62943,"Ongoing","Synthes USA HQ, Inc.","West Chester","PA","US","Voluntary: Firm Initiated","Letter","Nationwide Distribution-including Puerto Rico and the states of AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV and WY.","Z-0782-2013","Class II","Synthes(R) Spine Vectra, Vectra-T and Vectra-One Anterior Cervical Plating for Spinal Fusion, Adjustable Drill Stop, Part Number 03.613.012. Synthes Vectra System, Synthes Vectra-One System and Synthes Vectra-T System is intended for anterior plate and screw fixation of the cervical spine (C2-C7). ","Adjustable Drill Stop, Part Number 03.613.012 - Lots 5456424, 5494147, 5557938, and 5557939",,"48","Although the reported incidence is low, there is the potential for the drill stop to slip on the drill bit resulting in an adverse event.",8/6/2012,"08/06/2012",2/13/2013,"02/13/2013"
"Devices",62950,"Ongoing","Zoll Circulation, Inc.","Sunnyvale","CA","US","Voluntary: Firm Initiated","Letter","Worldwide distribution.","Z-0658-2013","Class II","AutoPulse Resuscitation System Model 100, Mfg by:Zoll Circulation Sunnyvale, CA. The AutoPulse Model 100 Automatic Mechanical Chest compressor is intended to be used as an adjunct to manual CPR, on adult patients only, in cases of clinical death as defined by lack of spontaneous breathing and pulse.","all",".","3881 in US, 1846 ROW.","Complaints associated with an unexpected stop in AutoPulse compressions.",8/8/2012,"08/08/2012",1/16/2013,"01/16/2013"
"Biologics",62974,"Terminated","LifeShare Blood Centers","Monroe","LA","US","Voluntary: Firm Initiated","FAX","Texas","B-0770-13","Class III","Fresh Frozen Plasma (Apheresis)","W036511136444;",".","1 unit","Blood product, collected from a donor whose donor records failed answers to follow-up questions regarding vaccinations, was distributed",7/10/2012,"07/10/2012",3/27/2013,"03/27/2013"
"Drugs",62983,"Ongoing","Axcentria Pharmaceuticals LLC","Telford","PA","US","Voluntary: Firm Initiated","Letter","MI","D-134-2013","Class III","Major Oral Peroxide (Carbamide Peroxide 10%), 2 fl oz (60 mL), Distributed by: Major Pharmaceuticals 31778 Enterprise Drive, Livonia, MI 48150, NDC 0904-4062-03","Lot #s L11065, exp 12/2013; B12019, exp 2/2014; B12020, exp 2/2014; and D12035, exp 4/2014.",".","17,679 bottles","Stability data does not support expiration date: Stability data indicates the Carbamide Peroxide will degrade below acceptable levels within the 24-month expiration date printed on the packaging.",8/17/2012,"08/17/2012",1/30/2013,"01/30/2013"
"Devices",62993,"Ongoing","Spine Smith Partners LP","Austin","TX","US","Voluntary: Firm Initiated","Letter","Distributed in Texas.","Z-0932-2013","Class II","Cynch Lordotic T-PLlF Implant. Intervertebral fusion device with bone graft, for use with supplemental fixation. ","Part Number: 0609-2809-06, Lot: 39AQ",,"3 units","Implants were incorrectly laser marked as 23mm instead of 28mm.",8/24/2012,"08/24/2012",3/20/2013,"03/20/2013"
"Food",63029,"Ongoing","N4h Research Llc","Austin","TX","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","The product is distributed in Texas","F-0695-2014","Class II","N4H RESEARCH Easy Protein 20 GRAMS OF PROTEIN PER SERVING NEUTRAL FLAVOR ALL NATURAL GLUTEN FREE 16 FL OZ Ingredients: Pure deionized water, Actinase [patent pending blend of enzymatically hydrolyzed (predigested) collagenic protein isolate, whey protein, isolate (milk) and casein protein isolate (milk)], pure cane sugar, citric acid, natural flavor, stevia extract. Distributed by N4H Research Inc. 11044 Research Blvd., Suite D130 Austin, TX 78759 (512) 244-1881 www.n4hresearch.com","BEST FEB 23 2014 , PP 0542 5101 Lot # 5101",".","139/16 oz. bottles","Mold in the product.",4/12/2012,"04/12/2012",12/11/2013,"12/11/2013"
"Devices",63030,"Ongoing","Philips Medical Systems North America Co. Phillips","Bothell","WA","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution - USA (nationwide) and the countries of Japan and Malaysia.","Z-0643-2013","Class II","Philips and Laerdal brands of HeartStart HS1 Defibrillator Family Model number M5066A, M5067A, and M5068A Automated External Defibrillator Manufactured by Philips Medical Systems, Seattle, WA 98121 USA. The HS1 Defibrillator is intended to treat ventricular fibrillation, the most common cause of sudden cardiac arrest. Using voice prompts, light emitting diodes (LEDs) and buttons, the user is guided through the response. The HS1 uses a SMART biphasic, impedance compensating exponential waveform to deliver a nominal 150 J to adults and nominal 50 J to infants/children. ","HS1 product family all start with A in the serial number and break down into 3 catalog numbers - M5066A, M5067A and M5068A: 1) M5066A (referred to as Onsite or HS1), Philips brand, 510 (k) = K020715, sold nationally and internationally, serial numbers range from A021-00038 through A12E-03490, with 306,108 total devices. 2) M5067A, Philips brand 510(k) = K040904, sold nationally and internationally, serial numbers range from A05C-00727 through A12D-01406, with 978 total devices. 3) M5068A, Philips brand 510(k) = K020715, sold nationally and internationally, serial numbers range from A021J-00207 through A12E-01900, with 22,760 total devices 4) M5066A, Laerdal brand, 510 (k) = K020715, sold internationally, serial numbers range from A021-00036 through A12D-02148, with 60,433 total devices. 5) M5067A, Laerdal brand, sold as Home device- cleared for OTC on initial 510(k) = K040904, serial numbers range from A021-00133 through A11B-00970, with 8659 total devices. 6) M5068A, Laerdal brand, 510(k) = K020715, sold internationally, serial numbers range from A02K-00172 through A11H-00868, with 5217 total devices. Please note the serial number range represents first and last serial number for each model. Serial numbers are not continguous. Laerdal is a distribution partner in EU and Canada, sold internationally ",".","Estimate 613,000 devices shipped ","Philips determined that it is important to clarify information in the Owner's Manual and keep customers informed about the maintenance of their FRx (models 861304 and 861305), OnSite (models M5066A and M5067A), or HeartStart Home (model M5068A) automated external defibrillators (AEDs) shipped between December 2005 and July 2012. Philips had determined there is a need to emphasize the importance of all owners contacting their local Philips representative if an affected FRx or HS1 AED has emitted a pattern of triple chirps. If the device is emitting a pattern of triple chirps, it is a signal that the defibrillator's behavior needs to be investigated by Philips.",7/26/2012,"07/26/2012",1/16/2013,"01/16/2013"
"Devices",63030,"Ongoing","Philips Medical Systems North America Co. Phillips","Bothell","WA","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution - USA (nationwide) and the countries of Japan and Malaysia.","Z-0642-2013","Class II","Philips HeartStart FRx 861304 Automated External Defibrillator Manufactured by Philips Medical Systems, Seattle, WA 98121 USA; and Laerdal branded FRx 861305 The FRx Defibrillator is intended to treat ventricular fibrillation, the most common cause of sudden cardiac arrest. Using voice prompts, light emitting diodes (LEDs) and buttons, the user is guided through the response. The FRx uses a SMART biphasic, impedance compensating exponential waveform to deliver a nominal 150 J to adults and nominal 50 J to infants/children. ","1)Philips brand FRx Model Number 861304 under 510(k) K050004, sold nationally and Internationally, Serial numbers range from BO4L-00001 through B12F-00286 and represents 181,226 devices; 2) Laerdal brand FRx Model Number 861305 unfrt 510(k) K050004, sold nationally and Internationally, serial numbers range from B04L-00013 through B12E-04135 and represents 20,372 devices. Please note the serial number range represents first and last serial number for each model. Serial numbers are not continguous.",".","201,598","Philips determined that it is important to clarify information in the Owner's Manual and keep customers informed about the maintenance of their FRx (models 861304 and 861305), OnSite (models M5066A and M5067A), or HeartStart Home (model M5068A) automated external defibrillators (AEDs) shipped between December 2005 and July 2012. Philips had determined there is a need to emphasize the importance of all owners contacting their local Philips representative if an affected FRx or HS1 AED has emitted a pattern of triple chirps. If the device is emitting a pattern of triple chirps, it is a signal that the defibrillator's behavior needs to be investigated by Philips.",7/26/2012,"07/26/2012",1/16/2013,"01/16/2013"
"Drugs",63048,"Ongoing","Globe All Wellness, LLC","Hollywood","FL","US","Voluntary: Firm Initiated","Telephone","Nationwide and Puerto Rico and internationally to Barbados, Brazil, Canada, Cyprus, Equador, France, Germany, Israel, Mexico, and Netherlands.","D-148-2013","Class I","SLIM XTREME Herbal Slimming Capsule, supplied in 30-count bottles. Another Product Forumulated and Distributed By: Globe All Wellness, LLC Hollywood, FL 33020 www.diet66.com Inquires Call 877.842.9873","All Lots of SlimXtreme with the following format stamped in black ink on the bottom of the bottle ''MFD: XX.XX.20XX EXP: XX.XX.20XX'', which were manufactured overseas, are being recalled.",,"40,400 bottles","Marketed Without an Approved NDA/ANDA: Product tested positive for Sibutramine, an appetite suppressant that was withdrawn from the U.S. market in October 2010 for safety reasons, making this product an unapproved new drug.",9/20/2012,"09/20/2012",2/13/2013,"02/13/2013"
"Food",63060,"Terminated","Brand New Energy, LLC","Burbank","CA","US","Voluntary: Firm Initiated","Press Release","ID, NY, KS, CO,","F-1325-2013","Class I","EphBurn 25, 90 count bottle with red capsules","all lot codes, no UPC codes",".","1000 units","Brand New Energy is recalling all lot codes of EphBurn 25 because it may contain ephedrine alkaloids, making it an unapproved drug.",8/30/2012,"08/30/2012",4/24/2013,"04/24/2013"
"Devices",63108,"Ongoing","St. Jude Medical","Plano","TX","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution--USA (nationwide) including Puerto Rico and the countries of Argentina, Australia, Austria, Belgium, Brazil, canada, Colombia, Cyprus, Czech Republic, Denmark, Finland, France, Germany, Greece, India, Ireland, Israel, Italy, Japan, Mexico, Netherlands, Saudi, South Africa, Spain, Sweden, Switzerland, Turkey and United Kingdom.","Z-1836-2013","Class II","Eon Mini - 3788 (IPG), Eon Mini system is indicated as an aid in the management of chronic intractable pain of the trunk and/or limbs including unilateral or bilateral pain associated with the following: failed back, surgery syndrome, intractable low back and leg pain.","Multiple lots recalled are the ones with supplier's inner battery lots of 326-508",,"34,617","As part of St. Jude Medical's routine tracking and product monitoring, they have received a total of 214 reports, out of 34,617 Eon Mini IPGs, that lost the ability to communicate or recharge due to an inner battery weld issue resulting in loss of pain relief and subsequent explant. Explant surgery, as with any surgery, presents a risk to patient health. Adverse events associated with an unplanned surgery may be comparable to adverse events associated with planned operations, and may include pain, scarring, and infection, as well as complications from anesthesia. Product investigation and analysis conducted by St. Jude Medical as a result of reports of the inability to communicate or recharge the Eon Mini IPG has identified weld cracks in the IPG's inner battery as the cause of this issue. Prior analysis had indicated that moisture was the cause of weld cracking. However, with the occurrence of additional weld cracks, the firm's investigation has determined that the current weld cracks are not attributed to moisture within the battery. Thorough analysis of the cracked batteries and review of the battery manufacturing processes has identified a need to more frequently maintain and replace certain tools during the internal battery welding process by a St. Jude Medical supplier in order to assure complete alignment between the welding apparatus and the battery. It is important to note that the battery is contained within the hermetically-sealed IPG case and cannot leak electrolyte outside the IPG casing. ",7/26/2012,"07/26/2012",8/7/2013,"08/07/2013"
"Devices",63109,"Ongoing","St. Jude Medical","Plano","TX","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution - USA Nationwide Including Puerto Rico and countries of: Argentina, Australia, Belgium, Brazil, Canada, China, Chile, Colombia, Ireland, Israel, India, Malaysia, Mexico, Saudi Arabia, Singapore, South Africa, South Korea, Switzerland and United Kingdom.","Z-1739-2013","Class II","Eon Mini - 3721 (Charger). Product Usage: Eon Mini system is indicated as an aid in the management of chronic intractable pain of the trunk and/or limbs including unilateral or bilateral pain associated with the following: failed back surgery syndrome, intractable low back and leg pain. ","All serial numbers manufactured",".","70,638 (combined total of the Eon and the Eon Mini systems)","St. Jude Medical has informed your doctor that a number of cases have been reported in which discomfort associated with heating occurred at the device site while patients were using the Charging System to charge their spinal cord stimulator. In three cases, patients received a burn to the skin (one second-degree and two first-degree burns) at the implant site. As of June 30, 2012, St. Jude Medical has received 127 total patient complaints of warmth or heating at the IPG implant site during charging for the Eon IPG and 198 reports of similar symptoms for the Eon Mini IPG. These reports resulted in total of 29 explants for Eon IPGs and 43 explants for Eon Mini IPGs. As of June 30, 2012, they have received three reports of skin surface burns (one 2nd degree and two 1st degree burns) believed to be associated with heating during charging. Explant surgery, as with any surgery, presents a risk to patient health. Adverse events associated with an unplanned surgery may be comparable to adverse events associated with planned operations, and may include pain, scarring, and infection, as well as complications from anesthesia.",7/26/2012,"07/26/2012",7/24/2013,"07/24/2013"
"Devices",63109,"Ongoing","St. Jude Medical","Plano","TX","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution - USA Nationwide Including Puerto Rico and countries of: Argentina, Australia, Belgium, Brazil, Canada, China, Chile, Colombia, Ireland, Israel, India, Malaysia, Mexico, Saudi Arabia, Singapore, South Africa, South Korea, Switzerland and United Kingdom.","Z-1738-2013","Class II","Eon - 3701 (Wall Charger) and 3711 (Portable Charger). Product Usage: Eon: Eon system is indicated as an aid in the management of chronic intractable pain of the trunk and/or limbs including unilateral or bilateral pain associated with the following: failed back surgery syndrome, intractable low back and leg pain. Eon Mini: Eon Mini system is indicated as an aid in the management of chronic intractable pain of the trunk and/or limbs including unilateral or bilateral pain associated with the following: failed back surgery syndrome, intractable low back and leg pain. ","All serial numbers manufactured",".","70,638 (combined total for Eon and Eon mini systems)","St. Jude Medical has informed your doctor that a number of cases have been reported in which discomfort associated with heating occurred at the device site while patients were using the Charging System to charge their spinal cord stimulator. In three cases, patients received a burn to the skin (one second-degree and two first-degree burns) at the implant site. As of June 30, 2012, St. Jude Medical has received 127 total patient complaints of warmth or heating at the IPG implant site during charging for the Eon IPG and 198 reports of similar symptoms for the Eon Mini IPG. These reports resulted in total of 29 explants for Eon IPGs and 43 explants for Eon Mini IPGs. As of June 30, 2012, they have received three reports of skin surface burns (one 2nd degree and two 1st degree burns) believed to be associated with heating during charging. Explant surgery, as with any surgery, presents a risk to patient health. Adverse events associated with an unplanned surgery may be comparable to adverse events associated with planned operations, and may include pain, scarring, and infection, as well as complications from anesthesia.",7/26/2012,"07/26/2012",7/24/2013,"07/24/2013"
"Biologics",63118,"Terminated","CSL Plasma, Inc.","Wichita","KS","US","Voluntary: Firm Initiated","E-Mail","Switzerland, Germany, IL, MA, CA","B-0056-14","Class II","Source Plasma","41501223685 41501222076 41501220759 41501237868 41501237067 41501233971 41501236259 41501238019 41501236814 41501238414 41501235459 41501233613 41501234392 41501235942 41501230746 41501231685 41501230834 41501232565 41501230172 41501219416 41501216899 41501219248 41501211852 41501212628 41501119693 41501213209 41501119896 41501119642 41501212290 41501119984 41501212070 41501117794 41501118105 41501117209 41501119360 41501116812 41501118914 41501117217 41501117399 41501116919 41501117276 41501118287 41501117962 41501119490 41501119300 41501119482 41501117145 41501119116 41501117508 41501117153 41501116601 41501116089 41501115959 41501116118 41501116556 41501116070 41501115625 41501114083 41501116610 41501117065 41501115490 41501116388 41501111966 41501110330 41501113953 41501114809 41501112643 41501112686 41501112651 41501111544 41501112432 41501111253 41501110904 41501111552 41501112758 41501112619 41501110461 41501112635 41501112740 41501112563 41501111034 41501110023 41500969160 41500968626 41500969872 41500969821 41500969856 41500969047 41501110040 41500968474 41500968941 41500968220 41501110226 41501110234 41500969565 41501110533 41500968482 41500969864 41500968730 41500969733 41500968757 41500967893 41500968407 41500967762 41500967404 41500968140 41500966823 41500966436 41500965994 41500967922 41500968917 41500965388 41500967498 41500965345 41500967720 41500967287 41500967519 41500962531 41500964553 41500962777 41500965601 41500963139 41500962929 41500965687 41500964730 41500966057 41500965150 41500964940 41500962814 41500962515 41500964393 41500962865 41500965652 41500966073 41500964490 41500964043 41500965062 41500964220 41500963921 41500965855 41500965943 41500965020 41500962646 41500965100 41500965193 41500963235 41500963155 41500961125 41500962380 41500960691 41500961870 41500960632 41500960990 41500963534 41500961598 41500963550 41500963331 41500962347 41500963358 41500961467 41500963649 41500962371 41500962304 41500960464 41500960940 41500962419 41500961600 41500960456 41500962267 41500961168 41500",".","1,243 units","Blood products, collected from a donor in which donor suitability was not adequately determined, were distributed.",7/20/2012,"07/20/2012",12/4/2013,"12/04/2013"
"Biologics",63120,"Terminated","Tissue Banks International","San Rafael","CA","US","Voluntary: Firm Initiated","Telephone","Allograft products were released for distribution to 6 consignees in US. located in CA, MD and PA.","B-0162-13","Class I","Bone, Human Tissue allograft; CeSpace (Brand for Aesculap, Inc.); Prepared by Aesculap, Inc., Center Valley, PA and distributed by TBI National Processing Center, San Rafael, CA","CL1202013057; CL1202013061; CL1202013064; CL1202013068; CL1202013071; CL1202013075; CL1202013079; CL1202013084; CL1202013077; CL1202013083; CL1202013056; CL1202013058; CL1202013059; CL1202013060; CL1202013062; CL1202013063; CL1202013065; CL1202013066; CL1202013067; CL1202013069; CL1202013070; CL1202013072; CL1202013073; CL1202013074; CL1202013076; CL1202013078; CL1202013080; CL1202013081; CL1202013082; CL1202013085; CL1202013086; CL1202013006; CL1202013004",".","33","Human tissue allografts, not processed in a manner that prevents the introduction, transmission, or spread of communicable disease, were distributed.",7/31/2012,"07/31/2012",1/16/2013,"01/16/2013"
"Biologics",63120,"Terminated","Tissue Banks International","San Rafael","CA","US","Voluntary: Firm Initiated","Telephone","Allograft products were released for distribution to 6 consignees in US. located in CA, MD and PA.","B-0163-13","Class I","Tendon, Human Tissue allograft; TranZgraft (brand for TBI); Product is prepared and distributed by TBI/Tissue Banks International, San Rafael, CA","CL1202013007; CL1202013008; CL1202013009; CL1202013010; CL1202013003",".","5","Human tissue allografts, not processed in a manner that prevents the introduction, transmission, or spread of communicable disease, were distributed.",7/31/2012,"07/31/2012",1/16/2013,"01/16/2013"
"Devices",63123,"Ongoing","GE Healthcare, LLC","Waukesha","WI","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution - USA, including DC and the states of AL, AK, AR, AZ, CA, CO, CT, DE, FL, GA, HI, IA, ID, IN, IL, KY, KS, LA, MA, MD, ME, MI, MN, MO,MS, MT, NC, NE, NJ, NM, NY, NV, OH, OK, OR, PA, SC, SD, TN, TX, UT, VA, VT, WA, WI, and WV, and the countries of Albania, Australia, Austria, Bahrain, Bangladesh, Belgium, Canada, China, Czech Rep., Egypt, Finland, France, Germany, Great Britain, Greece, India, Indonesia, Ireland, Israel, Italy, Jordan, Kazakhstan, S. Korea, Malaysia, Netherlands, New Zealand, Norway, Poland, Portugal, Romania, Russia, Saudi Arabia, Singapore, Slovakia, South Africa, Spain, Sweden, Switzerland, Thailand, Turkey, and Arab Emirates,","Z-0606-2013","Class I","GE Giraffe and Panda T-Piece Resuscitation System labeled ***T-Piece Neonatal Patient Circuit Kit Disposable with Size 1 Mask***M1091335 QTY: 10 T-Piece Disposable Circuit, QTY: 10, M1091316 T-Piece Disposable Circuit Kit with Mask Size O; M1091365 QTY: 10 T-Piece Disposable Circuit Kit with Mask, Size 1, Lot 1981713 *** Ohmeda Medical, A Division of Datex-Ohmeda, Inc. A General Electric Company Laurel, MD 20723 USA MADE IN USA*** Provides the basic equipment required for pulmonary resuscitation of infants.","7742443, 7785387, 7860461, 7875369, 7909560, and 8145199.",".","209,805 circuits","Disposable T-Piece circuits used with resuscitation systems are unable to achieve maximum Peak Inspiratory Pressure (PIP) during the pre-use check out procedure.",6/26/2012,"06/26/2012",1/2/2013,"01/02/2013"
"Veterinary",63137,"Ongoing","Breeders Choice Pet Foods Inc","Irwindale","CA","US","Voluntary: Firm Initiated","Letter","U.S. states to include California, Georgia, Illinois, Nevada, Ohio, Virginia, and Washington.","V-126-2013","Class I","AvoDerm Natural Lamb Meal Brown Rice Adult Dog Formula, 26 lb. Packaged in plastic bag with plastic liner.","Product Code/SKU/Material # 1000065074, UPC Code 0 5290702043 8, Best before dates of 28 Aug 2013, 29 Aug 2013, 30 Aug 2013.",".","7,392 bags","The firm recalled because the product has the potential to be contaminated with Salmonella.",9/7/2012,"09/07/2012",1/23/2013,"01/23/2013"
"Devices",63187,"Ongoing","Arjo, Inc. dba ArjoHuntleigh","Addison","IL","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution-USA (nationwide, including Puerto Rico) and the countries of Algeria, Angola, Australia, Austria, Bahrain, Belgium, Bosnia and Herzegovia, Botswana, Brazil, Canada, Chile, China, Colombia, Costa Rica, Croatia, Cuba, Czech Republic, Denmark, Ecuador, Egypt, Falkland Islands, France, Germany, Greece, Hong Kong, Hungary, India, Indonesia, Iran, Iraq, Ireland, Israel, Italy, Jordan, Kenya, Kuwait, Lebanon, Libyan Arab Jamahira, Lithuania, Malaysia, Malta, Mauritius, Mexico, Morocco, the Netherlands, New Zealand, Nigeria, Nordic, Norway, Oman, Panama, Poland, Qatar, Romania, Russian Federation, Saudi Arabia, Singapore, Slovenia, South Africa, Spain, Sri Lanka, Switzerland, Syrian Arab Republic, Thailand, Turkey, United Kingdom, United Arab Emirates, Uruguay, Venezuela and Yemen. ","Z-0476-2013","Class II","Enterprise 8000 Bed; an AC-powered adjustable hospital bed; ArjoHuntleigh AB, Eslov, Sweden; Models 8000, 8001, 8002, 8003, 8500, 8600, 8700 and 8800 General medicine, general and specialist surgery, care of the elderly, HDU, ITU, coronary care and oncology. The bed is appropriate for high dependency patients who pose a movement and handling risk and/or whose clinical condition requires that they are positioned with the minimal physical handling. ","Models 8000, 8001, 8002, 8003, 8500, 8600, 8700 and 8800; all serial numbers",".","94 beds in U.S., 31 beds in Canada, 26,010 beds in ROW","ArjoHuntleigh has received reports of unintended movement where the backrest and/or thigh sections of the bed have moved without anyone consciously pressing the control button. These incidents have occurred in High Dependency and Intensive Therapy environments where unintended movement of the patient may have serious consequences.",11/16/2012,"11/16/2012",8/14/2013,"08/14/2013"
"Devices",63187,"Ongoing","Arjo, Inc. dba ArjoHuntleigh","Addison","IL","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution-USA (nationwide, including Puerto Rico) and the countries of Algeria, Angola, Australia, Austria, Bahrain, Belgium, Bosnia and Herzegovia, Botswana, Brazil, Canada, Chile, China, Colombia, Costa Rica, Croatia, Cuba, Czech Republic, Denmark, Ecuador, Egypt, Falkland Islands, France, Germany, Greece, Hong Kong, Hungary, India, Indonesia, Iran, Iraq, Ireland, Israel, Italy, Jordan, Kenya, Kuwait, Lebanon, Libyan Arab Jamahira, Lithuania, Malaysia, Malta, Mauritius, Mexico, Morocco, the Netherlands, New Zealand, Nigeria, Nordic, Norway, Oman, Panama, Poland, Qatar, Romania, Russian Federation, Saudi Arabia, Singapore, Slovenia, South Africa, Spain, Sri Lanka, Switzerland, Syrian Arab Republic, Thailand, Turkey, United Kingdom, United Arab Emirates, Uruguay, Venezuela and Yemen. ","Z-0477-2013","Class II","Enterprise 9000 Bed; an AC-powered adjustable hospital bed with built-in electronic weigh scale, patient bed exit alarm, and under bed anti-entrapment system; ArjoHuntleigh AB, Eslov, Sweden; Models 9000, 9600, 9700 and 9800 General medicine, general and specialist surgery, care of the elderly, HDU, ITU, coronary care and oncology. The bed is appropriate for high dependency patients who pose a movement and handling risk and/or whose clinical condition requires that they are positioned with the minimal physical handling. ","Models 8000, 8001, 8002, 8003, 8500, 8600, 8700 and 8800; all serial numbers",".","1,324 beds in USA, 138 beds in Canada, 1,877 beds ROW","ArjoHuntleigh has received reports of unintended movement where the backrest and/or thigh sections of the bed have moved without anyone consciously pressing the control button. These incidents have occurred in High Dependency and Intensive Therapy environments where unintended movement of the patient may have serious consequences.",11/16/2012,"11/16/2012",8/14/2013,"08/14/2013"
"Biologics",63194,"Terminated","LifeServe Blood Center","Des Moines","IA","US","Voluntary: Firm Initiated","Telephone","IA","B-0119-13","Class II","Plasma Frozen within 24 hours (FP24)","W044112107840",".","1 unit","Blood product, which was collected from a donor in which donor suitability was not adequately determined, was distributed.",8/20/2012,"08/20/2012",1/2/2013,"01/02/2013"
"Food",63201,"Ongoing","Miami Growers Inc.","Jersey City","NJ","US","Voluntary: Firm Initiated","Letter","Nationwide","F-0970-2013","Class III","Siya Pan Gilori Net Wt. 180g. Distributed by: Miami Growers Inc. 80 Broadway Jersey City, NJ 07306 T 201-985-9322, 201-369-1500 Visit us: www.miamigrowersinc.com UPC 0893056003800","UPC 0893056003800 No lot code or expiration date",,"25 cases (40 packages each)","Pan Gilori contains Red dye, 45170-Rhodamine B-Basic Violet 10 and silver leaves and other metals at high levels.",5/15/2012,"05/15/2012",2/13/2013,"02/13/2013"
"Devices",63204,"Ongoing","Orthovita, Inc., dBA Stryker Orthobiologics.","Malvern","PA","US","Voluntary: Firm Initiated","Letter","USA Nationwide Distribution in the states of AZ, CA, CO, CT, DE, FL, GA, HI, IL, IN, KS, KY, LA, MD, ME, MI, MO, NC, ND, NH, NJ, NY, OH, OK, PA, RI, SC, TN, TX, UT, VA, WA, and WI.","Z-1393-2013","Class II","Stryker Orthobiologics Aliquot Delivery System Manual Surgical Instrument - Aliquot Plunger, 6'', Part Number 2110-0501 Product Usage: Facilitate placement of bone cement in weakened or diminished bone ","Manufacturer Part Number 2110-0501, Lot Numbers E909004R and E909004 ",".","414","There have been a few reported cases of the catheter breaking when removing the Aliquot catheter from the needle during vertebroplasty procedures. This has been attributed to bending of the catheter during the retraction from the needle. It was determined to be use errors. The correction is limited to a revision of the Directions for Use.",11/10/2012,"11/10/2012",6/5/2013,"06/05/2013"
"Devices",63204,"Ongoing","Orthovita, Inc., dBA Stryker Orthobiologics.","Malvern","PA","US","Voluntary: Firm Initiated","Letter","USA Nationwide Distribution in the states of AZ, CA, CO, CT, DE, FL, GA, HI, IL, IN, KS, KY, LA, MD, ME, MI, MO, NC, ND, NH, NJ, NY, OH, OK, PA, RI, SC, TN, TX, UT, VA, WA, and WI.","Z-1387-2013","Class II","Stryker Orthobiologics Aliquot Delivery System Manual Surgical Instrument - Aliquot Plunger Delivery System, 4'', Part Number 2090-0502 Product Usage: Facilitate placement of bone cement in weakened or diminished bone ","Manufacturer Part Number 2090-0502, Lot Number Q1006003",".","78","There have been a few reported cases of the catheter breaking when removing the Aliquot catheter from the needle during vertebroplasty procedures. This has been attributed to bending of the catheter during the retraction from the needle. It was determined to be use errors. The correction is limited to a revision of the Directions for Use.",11/10/2012,"11/10/2012",6/5/2013,"06/05/2013"
"Devices",63204,"Ongoing","Orthovita, Inc., dBA Stryker Orthobiologics.","Malvern","PA","US","Voluntary: Firm Initiated","Letter","USA Nationwide Distribution in the states of AZ, CA, CO, CT, DE, FL, GA, HI, IL, IN, KS, KY, LA, MD, ME, MI, MO, NC, ND, NH, NJ, NY, OH, OK, PA, RI, SC, TN, TX, UT, VA, WA, and WI.","Z-1398-2013","Class II","Stryker Orthobiologics Aliquot Delivery System Manual Surgical Instrument - Aliquot Beveled Needle, 6'', Part Number 2110-0524 Product Usage: Facilitate placement of bone cement in weakened or diminished bone ","Manufacturer Part Number 2110-0524, Lot Number E909009R and E909009R ",".","12","There have been a few reported cases of the catheter breaking when removing the Aliquot catheter from the needle during vertebroplasty procedures. This has been attributed to bending of the catheter during the retraction from the needle. It was determined to be use errors. The correction is limited to a revision of the Directions for Use.",11/10/2012,"11/10/2012",6/5/2013,"06/05/2013"
"Devices",63204,"Ongoing","Orthovita, Inc., dBA Stryker Orthobiologics.","Malvern","PA","US","Voluntary: Firm Initiated","Letter","USA Nationwide Distribution in the states of AZ, CA, CO, CT, DE, FL, GA, HI, IL, IN, KS, KY, LA, MD, ME, MI, MO, NC, ND, NH, NJ, NY, OH, OK, PA, RI, SC, TN, TX, UT, VA, WA, and WI.","Z-1389-2013","Class II","Stryker Orthobiologics Aliquot Delivery System Manual Surgical Instrument - Aliquot Plunger Delivery System, 4'', Part Number 2090-0501 Product Usage: Facilitate placement of bone cement in weakened or diminished bone ","Manufacturer Part Number 2090-0501, Lot Numbers A1109035 and Q1006002 ",".","411","There have been a few reported cases of the catheter breaking when removing the Aliquot catheter from the needle during vertebroplasty procedures. This has been attributed to bending of the catheter during the retraction from the needle. It was determined to be use errors. The correction is limited to a revision of the Directions for Use.",11/10/2012,"11/10/2012",6/5/2013,"06/05/2013"
"Devices",63204,"Ongoing","Orthovita, Inc., dBA Stryker Orthobiologics.","Malvern","PA","US","Voluntary: Firm Initiated","Letter","USA Nationwide Distribution in the states of AZ, CA, CO, CT, DE, FL, GA, HI, IL, IN, KS, KY, LA, MD, ME, MI, MO, NC, ND, NH, NJ, NY, OH, OK, PA, RI, SC, TN, TX, UT, VA, WA, and WI.","Z-1395-2013","Class II","Stryker Orthobiologics Aliquot Delivery System Manual Surgical Instrument - Aliquot Reamer, 8'', Part Number 2110-0525 Product Usage: Facilitate placement of bone cement in weakened or diminished bone ","Manufacturer Part Number 2110-0525, Lot Numbers E909006R",".","5","There have been a few reported cases of the catheter breaking when removing the Aliquot catheter from the needle during vertebroplasty procedures. This has been attributed to bending of the catheter during the retraction from the needle. It was determined to be use errors. The correction is limited to a revision of the Directions for Use.",11/10/2012,"11/10/2012",6/5/2013,"06/05/2013"
"Devices",63204,"Ongoing","Orthovita, Inc., dBA Stryker Orthobiologics.","Malvern","PA","US","Voluntary: Firm Initiated","Letter","USA Nationwide Distribution in the states of AZ, CA, CO, CT, DE, FL, GA, HI, IL, IN, KS, KY, LA, MD, ME, MI, MO, NC, ND, NH, NJ, NY, OH, OK, PA, RI, SC, TN, TX, UT, VA, WA, and WI.","Z-1390-2013","Class II","Stryker Orthobiologics Aliquot Delivery System Manual Surgical Instrument - Aliquot Syringe Delivery System, 6'', Part Number 2090-0504 Product Usage: Facilitate placement of bone cement in weakened or diminished bone ","Manufacturer Part Number 2090-0504, Lot Numbers A1006026 and A1111020 ",".","155","There have been a few reported cases of the catheter breaking when removing the Aliquot catheter from the needle during vertebroplasty procedures. This has been attributed to bending of the catheter during the retraction from the needle. It was determined to be use errors. The correction is limited to a revision of the Directions for Use.",11/10/2012,"11/10/2012",6/5/2013,"06/05/2013"
"Devices",63204,"Ongoing","Orthovita, Inc., dBA Stryker Orthobiologics.","Malvern","PA","US","Voluntary: Firm Initiated","Letter","USA Nationwide Distribution in the states of AZ, CA, CO, CT, DE, FL, GA, HI, IL, IN, KS, KY, LA, MD, ME, MI, MO, NC, ND, NH, NJ, NY, OH, OK, PA, RI, SC, TN, TX, UT, VA, WA, and WI.","Z-1396-2013","Class II","Stryker Orthobiologics Aliquot Delivery System Manual Surgical Instrument - Aliquot Reamer, 6'', Part Number 2110-0504 Product Usage: Facilitate placement of bone cement in weakened or diminished bone ","Manufacturer Part Number 2110-0504, Lot Number E909007R ",".","7","There have been a few reported cases of the catheter breaking when removing the Aliquot catheter from the needle during vertebroplasty procedures. This has been attributed to bending of the catheter during the retraction from the needle. It was determined to be use errors. The correction is limited to a revision of the Directions for Use.",11/10/2012,"11/10/2012",6/5/2013,"06/05/2013"
"Devices",63204,"Ongoing","Orthovita, Inc., dBA Stryker Orthobiologics.","Malvern","PA","US","Voluntary: Firm Initiated","Letter","USA Nationwide Distribution in the states of AZ, CA, CO, CT, DE, FL, GA, HI, IL, IN, KS, KY, LA, MD, ME, MI, MO, NC, ND, NH, NJ, NY, OH, OK, PA, RI, SC, TN, TX, UT, VA, WA, and WI.","Z-1392-2013","Class II","Stryker Orthobiologics Aliquot Delivery System Manual Surgical Instrument - Aliquot Catheter, 8'', Part Number 2110-0526 Product Usage: Facilitate placement of bone cement in weakened or diminished bone ","Manufacturer Part Number 2110-0526, Lot Numbers E908004R and E908004",".","27","There have been a few reported cases of the catheter breaking when removing the Aliquot catheter from the needle during vertebroplasty procedures. This has been attributed to bending of the catheter during the retraction from the needle. It was determined to be use errors. The correction is limited to a revision of the Directions for Use.",11/10/2012,"11/10/2012",6/5/2013,"06/05/2013"
"Devices",63204,"Ongoing","Orthovita, Inc., dBA Stryker Orthobiologics.","Malvern","PA","US","Voluntary: Firm Initiated","Letter","USA Nationwide Distribution in the states of AZ, CA, CO, CT, DE, FL, GA, HI, IL, IN, KS, KY, LA, MD, ME, MI, MO, NC, ND, NH, NJ, NY, OH, OK, PA, RI, SC, TN, TX, UT, VA, WA, and WI.","Z-1397-2013","Class II","Stryker Orthobiologics Aliquot Delivery System Manual Surgical Instrument - Aliquot Plunger, 8'', Part Number 2110-0502 Product Usage: Facilitate placement of bone cement in weakened or diminished bone ","Manufacturer Part Number 2110-0502, Lot Number E909008R ",".","17","There have been a few reported cases of the catheter breaking when removing the Aliquot catheter from the needle during vertebroplasty procedures. This has been attributed to bending of the catheter during the retraction from the needle. It was determined to be use errors. The correction is limited to a revision of the Directions for Use.",11/10/2012,"11/10/2012",6/5/2013,"06/05/2013"
"Devices",63204,"Ongoing","Orthovita, Inc., dBA Stryker Orthobiologics.","Malvern","PA","US","Voluntary: Firm Initiated","Letter","USA Nationwide Distribution in the states of AZ, CA, CO, CT, DE, FL, GA, HI, IL, IN, KS, KY, LA, MD, ME, MI, MO, NC, ND, NH, NJ, NY, OH, OK, PA, RI, SC, TN, TX, UT, VA, WA, and WI.","Z-1388-2013","Class II","Stryker Orthobiologics Aliquot Delivery System Manual Surgical Instrument - Aliquot Plunger Delivery System, 6'', Part Number 2090-0505 Product Usage: Facilitate placement of bone cement in weakened or diminished bone ","Manufacturer Part Number 2090-0505, Lot Number A1006027 ",".","164","There have been a few reported cases of the catheter breaking when removing the Aliquot catheter from the needle during vertebroplasty procedures. This has been attributed to bending of the catheter during the retraction from the needle. It was determined to be use errors. The correction is limited to a revision of the Directions for Use.",11/10/2012,"11/10/2012",6/5/2013,"06/05/2013"
"Devices",63204,"Ongoing","Orthovita, Inc., dBA Stryker Orthobiologics.","Malvern","PA","US","Voluntary: Firm Initiated","Letter","USA Nationwide Distribution in the states of AZ, CA, CO, CT, DE, FL, GA, HI, IL, IN, KS, KY, LA, MD, ME, MI, MO, NC, ND, NH, NJ, NY, OH, OK, PA, RI, SC, TN, TX, UT, VA, WA, and WI.","Z-1391-2013","Class II","Stryker Orthobiologics Aliquot Delivery System Manual Surgical Instrument - Aliquot Beveled Needle, 4'', Part Number 2110-0505 Product Usage: Facilitate placement of bone cement in weakened or diminished bone ","Manufacturer Part Number 2110-0505, Lot Numbers E909002 and E909002R",".","35","There have been a few reported cases of the catheter breaking when removing the Aliquot catheter from the needle during vertebroplasty procedures. This has been attributed to bending of the catheter during the retraction from the needle. It was determined to be use errors. The correction is limited to a revision of the Directions for Use.",11/10/2012,"11/10/2012",6/5/2013,"06/05/2013"
"Devices",63204,"Ongoing","Orthovita, Inc., dBA Stryker Orthobiologics.","Malvern","PA","US","Voluntary: Firm Initiated","Letter","USA Nationwide Distribution in the states of AZ, CA, CO, CT, DE, FL, GA, HI, IL, IN, KS, KY, LA, MD, ME, MI, MO, NC, ND, NH, NJ, NY, OH, OK, PA, RI, SC, TN, TX, UT, VA, WA, and WI.","Z-1394-2013","Class II","Stryker Orthobiologics Aliquot Delivery System Manual Surgical Instrument - Aliquot Diamond Needle, 4'', Part Number 2110-0506 Product Usage: Facilitate placement of bone cement in weakened or diminished bone ","Manufacturer Part Number 2110-0506, Lot Number E909005R ",".","19","There have been a few reported cases of the catheter breaking when removing the Aliquot catheter from the needle during vertebroplasty procedures. This has been attributed to bending of the catheter during the retraction from the needle. It was determined to be use errors. The correction is limited to a revision of the Directions for Use.",11/10/2012,"11/10/2012",6/5/2013,"06/05/2013"
"Devices",63204,"Ongoing","Orthovita, Inc., dBA Stryker Orthobiologics.","Malvern","PA","US","Voluntary: Firm Initiated","Letter","USA Nationwide Distribution in the states of AZ, CA, CO, CT, DE, FL, GA, HI, IL, IN, KS, KY, LA, MD, ME, MI, MO, NC, ND, NH, NJ, NY, OH, OK, PA, RI, SC, TN, TX, UT, VA, WA, and WI.","Z-1399-2013","Class II","Stryker Orthobiologics Aliquot Delivery System Manual Surgical Instrument - Aliquot Catheter, 6'', Part Number 2110-0503 Product Usage: Facilitate placement of bone cement in weakened or diminished bone ","Manufacturer Part Number 2110-0503, Lot Numbers E908003R and E908002",".","69","There have been a few reported cases of the catheter breaking when removing the Aliquot catheter from the needle during vertebroplasty procedures. This has been attributed to bending of the catheter during the retraction from the needle. It was determined to be use errors. The correction is limited to a revision of the Directions for Use.",11/10/2012,"11/10/2012",6/5/2013,"06/05/2013"
"Food",63209,"Ongoing","Food Source, Inc","Edinburg","TX","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Nationwide","F-1596-2013","Class I","Tomorrow's Tropicals Mangos Distributed by FoodSource A C.H. Robinson Company Edinburg, Texas 78539 ","All product sourced by Agricola Daniella, produced 7/16/12-9/14/12.",".","610,780","Out of an abundance of caution, the firm is voluntarily recalling mangoes that have been sourced from Agricola Daniella. The recall was initiated after the FDA warning to consumers not to eat any mangoes from Agricola Daniella was issued.",9/14/2012,"09/14/2012",7/17/2013,"07/17/2013"
"Devices",63226,"Ongoing","Surgical Tissue Network, Inc.","Orlando","FL","US","Voluntary: Firm Initiated",,"Worldwide Distribution including Turkey, Greece, & Mexico.","Z-0651-2013","Class II","Ultrafill DBM labeled in part: ***TISSUENET***Sterilized by T10^6 (r)***Description: UltraFill DBM***Size: 1cc***Product Code: RT53001***Donated Human Tissue Allograft***SINGLE PATIENT USE ONLY***FOR INTERNATIONAL USE ONLY***See Package Insert for Additional Information***TissueNet's Porcine DBM product line is used as a bone void filler","Product Code: RT53001 Tissue ID: TN29041-11-0072 Through TN29041-11-0081; and TN29041-11-0083 through TN29041-11-0119",".","25 units","Surgical Tissue Network Inc., DBA TissueNet Inc. recalled their UltraFill DBM Putty-Porcine (1 cc; 5cc; 10cc) because products may contain trace amounts of 316L Stainless Steel particulates.",3/14/2012,"03/14/2012",1/16/2013,"01/16/2013"
"Devices",63226,"Ongoing","Surgical Tissue Network, Inc.","Orlando","FL","US","Voluntary: Firm Initiated",,"Worldwide Distribution including Turkey, Greece, & Mexico.","Z-0652-2013","Class II","UltraFill DBM labeled in part: ***TISSUENET***Sterilized by T10^6 (r)***Description: UltraFill DBM***Size: 5cc***Product Code: RT53005***Donated Human Tissue Allograft***SINGLE PATIENT USE ONLY***FOR INTERNATIONAL USE ONLY***See Package Insert for Additional Information***TissueNet's Porcine DBM product line is used as a bone void filler.","Product Code: RT53005 Tissue ID: TN48005-11-0021 through TN48055-11-0059; TN48055-11-0070 through TN48055-11-0075; TN58063-11-0101 through TN58063-11-0142; TN61039-11-0031 through TN61039-11-0097; TN70037-11-0017 through TN70037-11-0018; TN70037-11-0020 through TN70037-11-0037; TN74060-11-0021 through TN74060-11-0047; TN74060-11-0050 through TN74060-11-0056",".","208 units","Surgical Tissue Network Inc., DBA TissueNet Inc. recalled their UltraFill DBM Putty-Porcine (1 cc; 5cc; 10cc) because products may contain trace amounts of 316L Stainless Steel particulates.",3/14/2012,"03/14/2012",1/16/2013,"01/16/2013"
"Devices",63226,"Ongoing","Surgical Tissue Network, Inc.","Orlando","FL","US","Voluntary: Firm Initiated",,"Worldwide Distribution including Turkey, Greece, & Mexico.","Z-0653-2013","Class II","UltraFill DBM labeled in part: ***TISSUENET***Sterilized by T10^6 (r)***Description: UltraFill DBM***Size: 10cc***Product Code: RT53010***Donated Human Tissue Allograft***SINGLE PATIENT USE ONLY***FOR INTERNATIONAL USE ONLY***See Package Insert for Additional Information***TissueNet's Porcine DBM product line is used as a bone void filler.","Product Code: RT53010 Tissue ID: 07-175-330 through 07-175-359; TN61032-11-0017 through TN61032-11-0041; TN62034-11-0001 through TN62034-11-0024; TN62053-11-0155 through TN62053-11-0209; TN67049-11-0291 through TN67049-11-0316; TN70037-11-0020 through TN70037-11-0037; TN74060-11-0021 through TN74060-11-0047; TN74060-11-0050 through TN74060-11-0056",".","160 units","Surgical Tissue Network Inc., DBA TissueNet Inc. recalled their UltraFill DBM Putty-Porcine (1 cc; 5cc; 10cc) because products may contain trace amounts of 316L Stainless Steel particulates.",3/14/2012,"03/14/2012",1/16/2013,"01/16/2013"
"Biologics",63228,"Terminated","Musculoskeletal Transplant Foundation","Edison","NJ","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Nationwide & Switzerland","B-0376-13","Class II","Bone","00511066221031, 00511066221032, 00511066221033, 00511066221034, 00511066221035, 00511066221036, 00511066221037, 00511066221038, 00511066221039, 00511066221040, 00511066221041, 03511084751013, 03511084751014, 03511084751015, 03511084751017, 03511084751021, 03511084751022, 03511084751023, 03511084751024, 03511084751025, 03511084751026, 03511084751027, 03511084751028, 03511084751029, 03511084751030, 03511084751031, 04111071021051, 04111071021052, 04111071021053, 04111071021054, 04111071021055, 04111071021056, 04111071021057, 04111071021058, 04111071021059, 04111071021060, 04111071021062, 04111071021063, 04111071021064, 04111071021065, 04111071021066, 04111071021067, 00811006631015, 00811006631016, 0081106631017, 05711068421016, 05711068421015, 04312005041024, 04312005041025, 04312005041031, 04312005041032, 04312005041033, 04312005041034, 04312005041035, 04312005041037, 04312005041039, 04312005041040, 04312005041041, 04312005041042, 04312005041043, 04312005041044, 04312005041045, 04312005041046, 04312005041047, 08211048841026, 08211048841027, 08211048841028, 08211048841029, 08211048841030, 08211048841031, 08211048841036, 08211048841039, 08211048841040, 08211048841041, 08211048841042, 08211048841032, 08211084841033, 08211048841035, 08211048841037, 08211048841038, 08211048841034, 06411024331027, 06411024331017, 06411024331018, 06411024331019, 06411024331020, 06411024331021, 06411024331022, 06411024331023, 06411024331024, 06411024331025, 06411024331026, 06411024331038, 06411024331039, 06411024331013, 06411024331036, 06411024331034, 06411024331009, 06411024331010, 06411024331011, 06411024331037, 06411024331014, 06411024331015, 06411024331016, 06411024331007, 06411024331028, 06411024331029, 06411024331030, 06411024331031, 06411024331046, 06411024331047, 06411024331040, 06411024331041, 06411024331042, 06411024331043, 06411024331035, 06411024331033, 06411024331012, 06411024331008, 06411024331049, 06411024331032, 06411024331048",,"122 units","Human tissue allografts, not processed in a manner that prevents the introduction, transmission, or spread of communicable disease, were distributed. ",7/20/2012,"07/20/2012",2/13/2013,"02/13/2013"
"Biologics",63229,"Terminated","Musculoskeletal Transplant Foundation","Edison","NJ","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","AK, AZ, CA, MI, PA. TX","B-0165-13","Class I","Bone","06711073061066; 06711073061059; 06711073061067; 06711073061073; 06711073061065; 06711073061060; 06711073061061; 06711073061062; 06711073061072; 06711073061069; 06711073061070; 06711073061071; 06711073061051; 06711073061052; 06711073061053; 06711073061054; 06711073061068; 06711073061056; 06711073061057; 06711073061058; 06711073061055; 06711073061064; 06711073061063; 00311087151030; 00311087151031; 00311087151032; 00311087151033; 00311087151034",".","28 units","Human tissue allografts, not processed in a manner that prevents the introduction, transmission, or spread of communicable disease, were distributed.",7/3/2012,"07/03/2012",1/16/2013,"01/16/2013"
"Biologics",63229,"Terminated","Musculoskeletal Transplant Foundation","Edison","NJ","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","AK, AZ, CA, MI, PA. TX","B-0164-13","Class I","Tendon","06711073061037; 06711073061038; 06711073061043; 06711073061027; 06711073061031; 06711073061041; 06711073061040; 06711073061028; 06711073061039; 06711073061029; 00311087151038; 00311087151045;0311087151039; 00311087151046; 00311087151047; 00311087151040; 00311087151042; 00311087151049",".","18 units",".Human tissue allografts, not processed in a manner that prevents the introduction, transmission, or spread of communicable disease, were distributed.",7/3/2012,"07/03/2012",1/16/2013,"01/16/2013"
"Devices",63230,"Ongoing","Synthes USA HQ, Inc.","West Chester","PA","US","Voluntary: Firm Initiated","Letter","Nationwide Distribution including CA, CO, CT, FL, GA, ID, IL, IN, LA, MA, MD, MI, MN, MT, NC, NJ, NY, OH, OR, PA, SC, TN, TX, UT, VA, WA, and WI.","Z-0395-2014","Class II","Synthes Titanium Minimally Invasive Reduction Screw System Polyaxial Screw Body, Part Number 04.631.500 Non-cervical spinal fixation devices intended for posterior pedicle screw fixation, posterior hook fixation, or anterolateral fixation.","All lots",".","757","This action is being initiated following a detailed investigation in response to reported complaints of post-operative locking cap loosening. Synthes has concluded that if the construct is mis-aligned during final tightening, the potential exists for locking caps to loosen post-operatively in certain situations.",9/7/2012,"09/07/2012",12/4/2013,"12/04/2013"
"Devices",63230,"Ongoing","Synthes USA HQ, Inc.","West Chester","PA","US","Voluntary: Firm Initiated","Letter","Nationwide Distribution including CA, CO, CT, FL, GA, ID, IL, IN, LA, MA, MD, MI, MN, MT, NC, NJ, NY, OH, OR, PA, SC, TN, TX, UT, VA, WA, and WI.","Z-0396-2014","Class II","Synthes Titanium Minimally Invasive Reduction Screw System Locking Cap, Part Number 04.631.502 Non-cervical spinal fixation devices intended for posterior pedicle screw fixation, posterior hook fixation, or anterolateral fixation.","All lots",".","745","This action is being initiated following a detailed investigation in response to reported complaints of post-operative locking cap loosening. Synthes has concluded that if the construct is mis-aligned during final tightening, the potential exists for locking caps to loosen post-operatively in certain situations.",9/7/2012,"09/07/2012",12/4/2013,"12/04/2013"
"Devices",63231,"Completed","Merit Medical Systems, Inc.","Chester","VA","US","Voluntary: Firm Initiated","Letter","Distributed in Mississippi and New Jersey.","Z-0663-2013","Class II","Merit Medical's Custom Procedural Tray or Kits K12T-03162B & K12T-02641F.Custom Procedural Tray or Kits is a combination of legally marketed medical devices placed into one container for the convenience of the user and used within the limits of the product's intended uses.","Tray and Kit - K12T-03162B & K12T-02641F/ Lots #T243169, Exp. 2012-12, T276753, Exp. 2013-04, T282465, Exp. 2013-02, T259844, Exp. 2013-02, T265274, Exp. 2013-02, Chloride Injection Lot 05-201-JT",".","422 total kits/trays","Custom Procedural Trays/Kits contain 0.9% Sodium Chloride Injection which were recalled because one confirmed customer report where four separate particulate issues were identified in four individual flexible containers. The particular matter may result acutely in local inflammation, phlebitis and/or generalized low-level allergic response to the particulate and/or embolize to other organs in the body.",9/14/2012,"09/14/2012",1/16/2013,"01/16/2013"
"Drugs",63232,"Ongoing","Evol Nutrition","Kennesaw","GA","US","Voluntary: Firm Initiated","Press Release","Nationwide","D-328-2013","Class I","Mojo Nights for Her, 1 capsule, UPC 7 18122 12133 5, Distributed By: Mojo Health Lauderhill, FL 33351"," All lots no Expiry",,"1000 blister packs (total both products)","Marketed Without an Approved NDA/ANDA: The products were found to contain FDA approved ingredients and analogues of FDA approved ingredients used to treat male erectile dysfunction, making them unapproved new drugs.",8/23/2012,"08/23/2012",5/22/2013,"05/22/2013"
"Drugs",63232,"Ongoing","Evol Nutrition","Kennesaw","GA","US","Voluntary: Firm Initiated","Press Release","Nationwide","D-327-2013","Class I","Mojo Nights, 1 capsule, UPC 7 18122 11983 7, Distributed By: Mojo Health Lauderhill, FL 33351","All lots, no Expiry",,"1000 blister packs (total both products)","Marketed Without an Approved NDA/ANDA: The products were found to contain FDA approved ingredients and analogues of FDA approved ingredients used to treat male erectile dysfunction, making them unapproved new drugs.",8/23/2012,"08/23/2012",5/22/2013,"05/22/2013"
"Food",63233,"Ongoing","GHSW, LLC","Houston","TX","US","Voluntary: Firm Initiated","Telephone","FL, LA, and TX","F-1609-2013","Class I","Signature CAFE Fruit Basket Medley Perishable Keep Refrigerated NET WT 30 oz (1 LB 14 OZ) 850g Ingredients: Red Grapes, Pineapple, Cantaloupe, Mango, Watermelon, Apples (Apples, Calcium Ascorbate [a blend of calcium and vitamins to maintain color] Distributed By Lucerne Foods, Inc. P.O. Box 99, Pleasanton, CA 94566-0009, UPC 021130069187 ","Use By: SEP 7 12, SEP 10 12, and SEP 12 12",".","1741 lb. total for recall","The product has the potential to be contaminated with Salmonella. Contains mangoes sourced from Agricola Daniella.",9/15/2012,"09/15/2012",7/17/2013,"07/17/2013"
"Food",63233,"Ongoing","GHSW, LLC","Houston","TX","US","Voluntary: Firm Initiated","Telephone","FL, LA, and TX","F-1605-2013","Class I","Garden Highway Fresh Fruit No Preservatives Perishable Keep Refrigerated Island Medley Net Wt. 1 lb (454g) Renaissance Food Group LLC Rancho Cordova, CA 95670 www.gardenhighway.com Ingredients: Pineapple, Mango, Papaya Packed in its own juice, UPC Code: 826766201044 ","Best if Sold By 9/8/12, 9/13/12. and 9/15/12",".","1741 lb. total for recall","The product has the potential to be contaminated with Salmonella. Contains mangoes sourced from Agricola Daniella.",9/15/2012,"09/15/2012",7/17/2013,"07/17/2013"
"Food",63233,"Ongoing","GHSW, LLC","Houston","TX","US","Voluntary: Firm Initiated","Telephone","FL, LA, and TX","F-1607-2013","Class I","Garden Highway Fresh Fruit No Preservatives Perishable Keep Refrigerated Mango Medley Net Wt. 10 oz (284g) Renaissance Food Group LLC, Rancho Cordova, CA 95670, UPC: 826766214334 www.gardenhighway.com Ingredients: Cantaloupe, Pineapple, Mango, Red Grapes Packed in its own juice","Best if Sold By: 9/8/12, 9/9/12, 9/11/12, 9/13/12 ",".","1741 lb. total for recall","The product has the potential to be contaminated with Salmonella. Contains mangoes sourced from Agricola Daniella.",9/15/2012,"09/15/2012",7/17/2013,"07/17/2013"
"Food",63233,"Ongoing","GHSW, LLC","Houston","TX","US","Voluntary: Firm Initiated","Telephone","FL, LA, and TX","F-1606-2013","Class I","Fruit Burst, ingredients: Cantaloupe, Pineapple, Honeydew, Watermelon, Red Grapes, Mango, Strawberries, Blueberries: 1) Garden Highway Fresh Fruit No Preservatives Perishable Keep Refrigerated, Net Wts 1 lb, UPC 826766241071 and 1.5 lbs., UPC 826766241279; 2) Fruit Burst Net Wt. 1 lb Renaissance Food Group LLC Rancho Cordova, CA 95670 www.gardenhighway.com. Packed in its own juice., UPC 826766241279; 2) Winn-Dixie, Jacksonville, FL 32254 Perishable, Keep Refrigerated Net Wts 1 lb (454g) UPC 021140017017, and 1.5 lb (680g), UPC 021140017079","1) 1 lb. and 1.5 lb., Best if Sold By: 9/8/12, 9/13/12, and 9/15/12 2) 1 lb Containers: , Best if Sold By: 9/7/12, 9/8/12, 9/10/12, 9/11/12, 9/12/12, and 9/15/12. 1.5 lb Containers: Best if Sold By: 9/7/12, 9/8/12, 9/10/12, 9/11/12, 9/12/12, 9/14/12, and 9/15/12 ",".","1741 lb. total for recall","The product has the potential to be contaminated with Salmonella. Contains mangoes sourced from Agricola Daniella.",9/15/2012,"09/15/2012",7/17/2013,"07/17/2013"
"Food",63233,"Ongoing","GHSW, LLC","Houston","TX","US","Voluntary: Firm Initiated","Telephone","FL, LA, and TX","F-1608-2013","Class I","Mango Spears: 1) Garden Highway Fresh Fruit Perishable Keep Refrigerated Mango Spears Net Wt 1 LB (454g) Renaissance Food Group LLC ,Rancho Cordova, CA 95670 www.gardenhighway.com Ingredients: Mango Packed in its own juice; UPC: 826766268498 2) Mango Spears 1 lb (454g) Ingredients: Mango Packed in its own juice. Distributed By: Winn-Dixie Stores, Inc. Jacksonville, FL 32254 Perishable Keep Refrigerated, UPC: 021140016942 ","1) Best if Sold By: 9/8/12, 9/11/12, and 9/13/12 2) Best if Sold By: 9/7/12, 9/8/12, 9/10/12, 9/11/12, 9/12/12, 9/14/12, and 9/15/12",".","1741 lb. total for recall","The product has the potential to be contaminated with Salmonella. Contains mangoes sourced from Agricola Daniella.",9/15/2012,"09/15/2012",7/17/2013,"07/17/2013"
"Food",63234,"Ongoing","Del Monte Fresh Produce North America, Inc","Dallas","TX","US","Voluntary: Firm Initiated","Press Release","Product was distributed directly to the states of Florida, Georgia, Missouri, North Carolina, Ohio, and Texas. Product was then shipped further from the firm's direct accounts.","F-1611-2013","Class I","Del Monte brand Tropical Fruit Medley, 16 oz., UPC 7-17524-77649-5","best by 9/26/12",".","3071 units total","In cooperation with the FDA's warning to not consume mangoes from Agricola Daniella in Mexico, Del Monte Fresh Produce N.A., Inc, is initiating a voluntary recall of 1,600 bowls of fresh-cut mangoes distributed to retail outlets due to the potential risk that the mangoes may contain Salmonella. Salmonella is an organism which can cause serious and sometimes fatal infections in young children, frail or elderly people, and others with weakened immune systems. Healthy persons infected with Salmonella often experience fever, diarrhea (which may be bloody), nausea, vomiting and abdominal pain. In rare circumstances, infection with Salmonella can result in the organism getting into the bloodstream and producing more severe illnesses such as arterial infections (i.e., infected aneurysms), endocarditis and arthritis. This recall is associated with FoodSource's (Edinburg, TX) recall of mangoes sourced from Agricola Daniella in Mexico.",9/20/2012,"09/20/2012",7/17/2013,"07/17/2013"
"Food",63234,"Ongoing","Del Monte Fresh Produce North America, Inc","Dallas","TX","US","Voluntary: Firm Initiated","Press Release","Product was distributed directly to the states of Florida, Georgia, Missouri, North Carolina, Ohio, and Texas. Product was then shipped further from the firm's direct accounts.","F-1616-2013","Class I","7 Eleven brand Strawberry/Kiwi/Mango, 6 oz., UPC 0-52548-51979-7 ","6 oz., best by 9/28/12 and 9/29/12",".","3071 units total","In cooperation with the FDA's warning to not consume mangoes from Agricola Daniella in Mexico, Del Monte Fresh Produce N.A., Inc, is initiating a voluntary recall of 1,600 bowls of fresh-cut mangoes distributed to retail outlets due to the potential risk that the mangoes may contain Salmonella. Salmonella is an organism which can cause serious and sometimes fatal infections in young children, frail or elderly people, and others with weakened immune systems. Healthy persons infected with Salmonella often experience fever, diarrhea (which may be bloody), nausea, vomiting and abdominal pain. In rare circumstances, infection with Salmonella can result in the organism getting into the bloodstream and producing more severe illnesses such as arterial infections (i.e., infected aneurysms), endocarditis and arthritis. This recall is associated with FoodSource's (Edinburg, TX) recall of mangoes sourced from Agricola Daniella in Mexico.",9/20/2012,"09/20/2012",7/17/2013,"07/17/2013"
"Food",63234,"Ongoing","Del Monte Fresh Produce North America, Inc","Dallas","TX","US","Voluntary: Firm Initiated","Press Release","Product was distributed directly to the states of Florida, Georgia, Missouri, North Carolina, Ohio, and Texas. Product was then shipped further from the firm's direct accounts.","F-1614-2013","Class I","Seasonal Blend: Del Monte brand, 32 oz., UPC 7-17524-77604-4; 7 Eleven brand, 6 oz., UPC 7-17524-77647-1; 16 oz., UPC 7-17524-77647-1; Wal-Mart, 10 oz., UPC 7-17524-77815-4; 16 oz., UPC 7-17524-77603-7; 32 oz., UPC 7-17524-77604-4 ","Del Monte, best by 9/27/12; 7 Eleven, 6 oz., best by 9/29/12, 16 oz., best by 9/27/12 and 9/29/12; Wal-Mart, all sizes, best by 9/26/12",".","3071 units total","In cooperation with the FDA's warning to not consume mangoes from Agricola Daniella in Mexico, Del Monte Fresh Produce N.A., Inc, is initiating a voluntary recall of 1,600 bowls of fresh-cut mangoes distributed to retail outlets due to the potential risk that the mangoes may contain Salmonella. Salmonella is an organism which can cause serious and sometimes fatal infections in young children, frail or elderly people, and others with weakened immune systems. Healthy persons infected with Salmonella often experience fever, diarrhea (which may be bloody), nausea, vomiting and abdominal pain. In rare circumstances, infection with Salmonella can result in the organism getting into the bloodstream and producing more severe illnesses such as arterial infections (i.e., infected aneurysms), endocarditis and arthritis. This recall is associated with FoodSource's (Edinburg, TX) recall of mangoes sourced from Agricola Daniella in Mexico.",9/20/2012,"09/20/2012",7/17/2013,"07/17/2013"
"Food",63234,"Ongoing","Del Monte Fresh Produce North America, Inc","Dallas","TX","US","Voluntary: Firm Initiated","Press Release","Product was distributed directly to the states of Florida, Georgia, Missouri, North Carolina, Ohio, and Texas. Product was then shipped further from the firm's direct accounts.","F-1610-2013","Class I","Mango (Fresh Cut): Del Monte brand slices, 32 oz., UPC 7-62357-07532-1, 32 oz., UPC 7-17524 72503-5; 16 oz., UPC 7-17524-71902-7, 8 oz., UPC 7-17524-72506-7, UPC 7-17524-72506-6; Del Monte brand chunks, 7 oz., 7 Eleven brand chunks, 6 oz., UPC 0-52548-52070-0 ","Del Monte, 32 oz., best by 9/26/12, 9/27/12 and 9/28/12; 16 oz., best by 9/26/12 and 9/27/12; 8 oz., best by 9/26/12; chunks 7 oz., Lot 05262101 7 Eleven chunks, 6 oz., best by 9/28/12 and 9/29/12 ",".","3071 unit total","In cooperation with the FDA's warning to not consume mangoes from Agricola Daniella in Mexico, Del Monte Fresh Produce N.A., Inc, is initiating a voluntary recall of 1,600 bowls of fresh-cut mangoes distributed to retail outlets due to the potential risk that the mangoes may contain Salmonella. Salmonella is an organism which can cause serious and sometimes fatal infections in young children, frail or elderly people, and others with weakened immune systems. Healthy persons infected with Salmonella often experience fever, diarrhea (which may be bloody), nausea, vomiting and abdominal pain. In rare circumstances, infection with Salmonella can result in the organism getting into the bloodstream and producing more severe illnesses such as arterial infections (i.e., infected aneurysms), endocarditis and arthritis. This recall is associated with FoodSource's (Edinburg, TX) recall of mangoes sourced from Agricola Daniella in Mexico.",9/20/2012,"09/20/2012",7/17/2013,"07/17/2013"
"Food",63234,"Ongoing","Del Monte Fresh Produce North America, Inc","Dallas","TX","US","Voluntary: Firm Initiated","Press Release","Product was distributed directly to the states of Florida, Georgia, Missouri, North Carolina, Ohio, and Texas. Product was then shipped further from the firm's direct accounts.","F-1612-2013","Class I","Del Monte brand Tropical Fruit Bowl, 28 oz., UPC 7-17524-77651-8; 64 oz., UPC 7-17524-77834-5","both sizes, best by 9/26/12",".","3071 units total","In cooperation with the FDA's warning to not consume mangoes from Agricola Daniella in Mexico, Del Monte Fresh Produce N.A., Inc, is initiating a voluntary recall of 1,600 bowls of fresh-cut mangoes distributed to retail outlets due to the potential risk that the mangoes may contain Salmonella. Salmonella is an organism which can cause serious and sometimes fatal infections in young children, frail or elderly people, and others with weakened immune systems. Healthy persons infected with Salmonella often experience fever, diarrhea (which may be bloody), nausea, vomiting and abdominal pain. In rare circumstances, infection with Salmonella can result in the organism getting into the bloodstream and producing more severe illnesses such as arterial infections (i.e., infected aneurysms), endocarditis and arthritis. This recall is associated with FoodSource's (Edinburg, TX) recall of mangoes sourced from Agricola Daniella in Mexico.",9/20/2012,"09/20/2012",7/17/2013,"07/17/2013"
"Food",63234,"Ongoing","Del Monte Fresh Produce North America, Inc","Dallas","TX","US","Voluntary: Firm Initiated","Press Release","Product was distributed directly to the states of Florida, Georgia, Missouri, North Carolina, Ohio, and Texas. Product was then shipped further from the firm's direct accounts.","F-1613-2013","Class I","Del Monte brand Tropical Blend, 7 oz., Lot number 05262101; 16 oz., UPC 7-17524-77868-7 ","both sizes, best by 9/27/12",".","3071 units total","In cooperation with the FDA's warning to not consume mangoes from Agricola Daniella in Mexico, Del Monte Fresh Produce N.A., Inc, is initiating a voluntary recall of 1,600 bowls of fresh-cut mangoes distributed to retail outlets due to the potential risk that the mangoes may contain Salmonella. Salmonella is an organism which can cause serious and sometimes fatal infections in young children, frail or elderly people, and others with weakened immune systems. Healthy persons infected with Salmonella often experience fever, diarrhea (which may be bloody), nausea, vomiting and abdominal pain. In rare circumstances, infection with Salmonella can result in the organism getting into the bloodstream and producing more severe illnesses such as arterial infections (i.e., infected aneurysms), endocarditis and arthritis. This recall is associated with FoodSource's (Edinburg, TX) recall of mangoes sourced from Agricola Daniella in Mexico.",9/20/2012,"09/20/2012",7/17/2013,"07/17/2013"
"Food",63234,"Ongoing","Del Monte Fresh Produce North America, Inc","Dallas","TX","US","Voluntary: Firm Initiated","Press Release","Product was distributed directly to the states of Florida, Georgia, Missouri, North Carolina, Ohio, and Texas. Product was then shipped further from the firm's direct accounts.","F-1618-2013","Class I","Fruit Bowl, generic, 48 oz., sold at Wal-Mart, UPC 7-17524-77687-7 ","best by 9/26/12",".","3071 units total","In cooperation with the FDA's warning to not consume mangoes from Agricola Daniella in Mexico, Del Monte Fresh Produce N.A., Inc, is initiating a voluntary recall of 1,600 bowls of fresh-cut mangoes distributed to retail outlets due to the potential risk that the mangoes may contain Salmonella. Salmonella is an organism which can cause serious and sometimes fatal infections in young children, frail or elderly people, and others with weakened immune systems. Healthy persons infected with Salmonella often experience fever, diarrhea (which may be bloody), nausea, vomiting and abdominal pain. In rare circumstances, infection with Salmonella can result in the organism getting into the bloodstream and producing more severe illnesses such as arterial infections (i.e., infected aneurysms), endocarditis and arthritis. This recall is associated with FoodSource's (Edinburg, TX) recall of mangoes sourced from Agricola Daniella in Mexico.",9/20/2012,"09/20/2012",7/17/2013,"07/17/2013"
"Food",63234,"Ongoing","Del Monte Fresh Produce North America, Inc","Dallas","TX","US","Voluntary: Firm Initiated","Press Release","Product was distributed directly to the states of Florida, Georgia, Missouri, North Carolina, Ohio, and Texas. Product was then shipped further from the firm's direct accounts.","F-1617-2013","Class I","Apple Blend, generic, 16 oz., sold at Wal-Mart, UPC 7-17524-77626-6 ","best by 9/26/12",".","3071 units total","In cooperation with the FDA's warning to not consume mangoes from Agricola Daniella in Mexico, Del Monte Fresh Produce N.A., Inc, is initiating a voluntary recall of 1,600 bowls of fresh-cut mangoes distributed to retail outlets due to the potential risk that the mangoes may contain Salmonella. Salmonella is an organism which can cause serious and sometimes fatal infections in young children, frail or elderly people, and others with weakened immune systems. Healthy persons infected with Salmonella often experience fever, diarrhea (which may be bloody), nausea, vomiting and abdominal pain. In rare circumstances, infection with Salmonella can result in the organism getting into the bloodstream and producing more severe illnesses such as arterial infections (i.e., infected aneurysms), endocarditis and arthritis. This recall is associated with FoodSource's (Edinburg, TX) recall of mangoes sourced from Agricola Daniella in Mexico.",9/20/2012,"09/20/2012",7/17/2013,"07/17/2013"
"Food",63234,"Ongoing","Del Monte Fresh Produce North America, Inc","Dallas","TX","US","Voluntary: Firm Initiated","Press Release","Product was distributed directly to the states of Florida, Georgia, Missouri, North Carolina, Ohio, and Texas. Product was then shipped further from the firm's direct accounts.","F-1615-2013","Class I","7 Eleven brand Pineapple/Mango/Grape, 6 oz., UPC 0-52548-51986-5 ","6 oz., best by 9/28/12 and 9/29/12",".","3071 units total","In cooperation with the FDA's warning to not consume mangoes from Agricola Daniella in Mexico, Del Monte Fresh Produce N.A., Inc, is initiating a voluntary recall of 1,600 bowls of fresh-cut mangoes distributed to retail outlets due to the potential risk that the mangoes may contain Salmonella. Salmonella is an organism which can cause serious and sometimes fatal infections in young children, frail or elderly people, and others with weakened immune systems. Healthy persons infected with Salmonella often experience fever, diarrhea (which may be bloody), nausea, vomiting and abdominal pain. In rare circumstances, infection with Salmonella can result in the organism getting into the bloodstream and producing more severe illnesses such as arterial infections (i.e., infected aneurysms), endocarditis and arthritis. This recall is associated with FoodSource's (Edinburg, TX) recall of mangoes sourced from Agricola Daniella in Mexico.",9/20/2012,"09/20/2012",7/17/2013,"07/17/2013"
"Veterinary",63240,"Ongoing","Kasel Associates Industries, Inc.","Denver","CO","US","Voluntary: Firm Initiated","Telephone","Beef Bully Sticks were distributed to Target locations in: AL, AZ, CA, CO, GA, IA, IL, IN, KS, MI, MN, NC, NY, OH, OR, PA, SC, TX, VA, WI. Chicken Jerky Treats were distributed to 57 Sam's Club locations in: CO, IA, ID, IL, KS, MO, MT, NE, OK, SD, UT, WY.","V-216-2013","Class I","Boots & Barkley American Beef Bully Sticks, 6 count, UPC 647263899189, Distributed by Target Corporation Minneapolis, MN 55403, Target Brands, Inc. Made in the U.S.A. Promotes Plaque and Tartar Reduction; packaged in transparent flexible plastic with a folded paper label enclosed with staples. The label is white, red and blue with black, white, red, and blue print writing and a photograph of a black and white dog. ","Best By dates of 20APR2014 DEN to 03OCT2014 DEN.",,"93,912 x 6 count bags","Kasel Industries is recalling Boots & Barkley American Beef Bully Sticks, 6 count, due to possible contamination with salmonella bacteria.",9/17/2012,"09/17/2012",7/3/2013,"07/03/2013"
"Veterinary",63240,"Ongoing","Kasel Associates Industries, Inc.","Denver","CO","US","Voluntary: Firm Initiated","Telephone","Beef Bully Sticks were distributed to Target locations in: AL, AZ, CA, CO, GA, IA, IL, IN, KS, MI, MN, NC, NY, OH, OR, PA, SC, TX, VA, WI. Chicken Jerky Treats were distributed to 57 Sam's Club locations in: CO, IA, ID, IL, KS, MO, MT, NE, OK, SD, UT, WY.","V-219-2013","Class I","Boots & Barkley, American Variety Pack Real Beef & Pork Treats for Dogs, net wt 32 oz., UPC 490830400086; Product of U.S.A. Distributed by TARGET Corporation, Minneapolis, MN 55403, Packaging is white, blue and red with red, black and blue print writing.","Best By 13SEP2014DEN.",,"912 x 32 oz bags","Kasel Associated Industries is voluntarily recalling a specific lot of Boots and Barkley American Variety Pack, due to possible contamination with Salmonella bacteria.",9/17/2012,"09/17/2012",7/3/2013,"07/03/2013"
"Veterinary",63240,"Ongoing","Kasel Associates Industries, Inc.","Denver","CO","US","Voluntary: Firm Initiated","Telephone","Beef Bully Sticks were distributed to Target locations in: AL, AZ, CA, CO, GA, IA, IL, IN, KS, MI, MN, NC, NY, OH, OR, PA, SC, TX, VA, WI. Chicken Jerky Treats were distributed to 57 Sam's Club locations in: CO, IA, ID, IL, KS, MO, MT, NE, OK, SD, UT, WY.","V-218-2013","Class I","Boots & Barkley Roasted American Pig Ears, net wt 12 oz, 12 count, UPC 647263899158. Delicious Treat for Dogs, Made in the U.S.A. Distributed by TARGET Corporation, Minneapolis, MN 55403.","Best By 13SEP2014DEN.",,"4,944 x 12 ct bags","Kasel Associated Industries is voluntarily recalling a specific lot of Boots & Barkley Roasted American Pig Ears, due to possible contamination with Salmonella bacteria.",9/17/2012,"09/17/2012",7/3/2013,"07/03/2013"
"Veterinary",63240,"Ongoing","Kasel Associates Industries, Inc.","Denver","CO","US","Voluntary: Firm Initiated","Telephone","Beef Bully Sticks were distributed to Target locations in: AL, AZ, CA, CO, GA, IA, IL, IN, KS, MI, MN, NC, NY, OH, OR, PA, SC, TX, VA, WI. Chicken Jerky Treats were distributed to 57 Sam's Club locations in: CO, IA, ID, IL, KS, MO, MT, NE, OK, SD, UT, WY.","V-217-2013","Class I","Nature's Deli Chicken Jerky Dog Treats, 2.5 lbs. bag, UPC 647263800208, Best By ''091913 DEN'', Division of Kasel Industries, Denver, CO 80205. Packaged in a transparent, flexible, plastic bag; the bag is yellow with black and white print writing and a photograph of a golden retriever dog on it.","Best By ''09192013 DEN''",,"2,304 x 2.5 lbs. bags","Kasel Associated Industries is voluntarily recalling a specific lot of Nature's Deli Chicken Jerky Dog Treats, 2.5 lbs. bag, due to possible contamination with Salmonella bacteria.",9/17/2012,"09/17/2012",7/3/2013,"07/03/2013"
"Drugs",63242,"Terminated","Hospira, Inc.","Lake Forest","IL","US","Voluntary: Firm Initiated","Telephone","NC","D-215-2013","Class III","Lactated Ringer's Injection, USP, 1000 mL, Rx only, Manufactured by Hospira, Inc., Lake Forest, IL 60045, NDC 0409-7953-09","Lot 16-836-FW, Exp 04/14",,"1,296 units","CGMP Deviations: Shipment of product not approved for release.",6/21/2012,"06/21/2012",4/3/2013,"04/03/2013"
"Devices",63244,"Ongoing","Aesculap, Inc.","Center Valley","PA","US","Voluntary: Firm Initiated","Letter","Nationwide Distribution including MI, PA and TX.","Z-0805-2013","Class II","Aesculap(R) - Miethke Shunt System, FT040T - Control Reservoir Set w/Distal Catheter and FT075P 0 Ventric Cathet, w/Stylet & RT-ANG Guide Central Nervous System Shunt and Components intended to shunt cerebrospinal fluid (CSF) from the lateral ventricles of the brain into the peritoneum.","Lots 4503489878, 4503792749, 4503682927, 4503508385, 4503789879, 4503800248 and 4503682935.",,"11","The deflector may not move freely on the ventricular catheter. The deflector comes pre-positioned at the 5 cm mark on the catheter. In some cases the surgeon will want to adjust the deflector to a different location on the catheter before placing it in the ventricle. There is a small percentage of cases where aggressively attempting to adjust the deflector has a potential to cause the catheter to tear.",6/4/2012,"06/04/2012",2/20/2013,"02/20/2013"
"Food",63252,"Ongoing","MR Cuts, L.p.","Dallas","TX","US","Voluntary: Firm Initiated","E-Mail","TX","F-1722-2013","Class I","Item # H175455 Mango Sliced 2/2.5 LB and 5 LB, Ingredients: Mango Packed By: Riley's Dallas, Texas 75226 Product of Mexico","All mango products manufactured from mangos sourced by Agricola Daniella. Lot Numbers 0909 and 0908 located on top film of the tray and also on the outer box.",".","40 cases","The product has the potential to be contaminated with salmonella. The mangos were sourced by Agricola Daniella.",9/18/2012,"09/18/2012",7/24/2013,"07/24/2013"
"Food",63252,"Ongoing","MR Cuts, L.p.","Dallas","TX","US","Voluntary: Firm Initiated","E-Mail","TX","F-1721-2013","Class I","Item # H996189 Mango Diced 1/2'' 5 LB, Ingredients: Mango Packed By: Riley's Dallas, Texas 75226 Product of Mexico","All mango products manufactured from mangos sourced by Agricola Daniella. Lot Numbers 0908 and 0913 located on top film of tray and also on the outer box.",".","8 cases","The product has the potential to be contaminated with salmonella. The mangos were sourced by Agricola Daniella.",9/18/2012,"09/18/2012",7/24/2013,"07/24/2013"
"Food",63252,"Ongoing","MR Cuts, L.p.","Dallas","TX","US","Voluntary: Firm Initiated","E-Mail","TX","F-1723-2013","Class I","Item # 2999 Mango Chunks 2/5 LB, Ingredients: Mango Packed By: Riley's Dallas, Texas 75226 Product of Mexico","All mango products manufactured from mangos sourced by Agricola Daniella. Lot Number 0913 located on top film of the tray and also on the outer box.",".","7 cases","The product has the potential to be contaminated with salmonella. The mangos were sourced by Agricola Daniella.",9/18/2012,"09/18/2012",7/24/2013,"07/24/2013"
"Drugs",63258,"Completed","Genentech Inc","South San Francisco","CA","US","Voluntary: Firm Initiated","E-Mail","Nationwide","D-135-2013","Class I","Trastuzumab Kit containing 1 vial Trastuzumab (nominal content: 440 mg); 1 20 mL multiple dose vial Bacteriostatic Water for Injection, USP (1.1% benzyl alcohol), Manufactured by Hospira, Inc., for Genentech, Inc., South San Francisco, CA 94080-4990, NDC 50242-903-69; and 1 Reconstitution Instructions per kit; Investigation Use only, Genentech, Inc., 1 DNA Way, South San Francisco, CA 94080-4990. ","Lot #: 454138, Exp 07/14 (containing Trastuzumab Lot #: 886618, Exp 12/14; and Bacteriostatic Water for Injection, USP Lot #: 08-368-DK-01, Exp 07/14) ",".","2,140 kits","Presence of Particulate Matter: One lot of Bacteriostatic Water for Injection, USP diluent vials that were packed with Trastuzumab Kits for investigational use has the potential to contain glass particulates. ",7/30/2012,"07/30/2012",1/30/2013,"01/30/2013"
"Food",63268,"Completed","The Sourdough: A European Bakery Inc.","Houston","TX","US","Voluntary: Firm Initiated","E-Mail","AR, LA, OK, and TX","F-1461-2013","Class I","Whole Foods 3 oz Peanut Butter Cookies sold under PLU 47963 from the retail store self-serve pastry case.","All cookies sold before September 29, 2012, manufactured from May 1, 2012 to September 24, 2012,",".",,"The cookies were manufactured using peanut butter recalled by Sunland, Inc. for salmonella.",9/24/2012,"09/24/2012",6/5/2013,"06/05/2013"
"Food",63268,"Completed","The Sourdough: A European Bakery Inc.","Houston","TX","US","Voluntary: Firm Initiated","E-Mail","AR, LA, OK, and TX","F-1460-2013","Class I","Whole Foods Mini Peanut Butter Cookies 12 pack sold in small, plain brown bags featuring a cellophane window on the front with an oval Whole Foods Market sticker that reads ''mini peanut butter cookies - OLD-FASHIONED TREATS FROM WHOLE FOOD MARKET-'' PLU 22096100000","All cookies sold before September 29, 2012, manufactured from May 1, 2012 to September 24, 2012",".",,"The cookies were manufactured using peanut butter recalled by Sunland, Inc. for salmonella ",9/24/2012,"09/24/2012",6/5/2013,"06/05/2013"
"Food",63268,"Completed","The Sourdough: A European Bakery Inc.","Houston","TX","US","Voluntary: Firm Initiated","E-Mail","AR, LA, OK, and TX","F-1462-2013","Class I","Whole Foods 3 oz Peanut Butter Chocolate Chunk Cookies sold under PLU 47963 from the retail store self-serve pastry case.","All cookies sold before September 29, 2012, manufactured from May 1, 2012 to September 24, 2012.",".",,"The cookies were manufactured using peanut butter recalled by Sunland, Inc. for salmonella.",9/24/2012,"09/24/2012",6/5/2013,"06/05/2013"
"Food",63277,"Ongoing","Pecan Deluxe Candy Company","Dallas","TX","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","CA, IA, MI, MO, NC, NV, NY, OH, PA, TX, UT, WI and Canada","F-1451-2013","Class I","Chunky Peanut Butter Ribbon, 40 lb Pail, Item Number 07-712-40, Manufactured by Pecan Deluxe Candy Company, 2570 Lone Star Drive, Dallas, TX 75212","Lot Numbers: 10077242, 10077231, 10077241, 101562, 101561, 10196141, 101961, 10196141, 10267231, 10267241, 11089211, 11089221, 11140241, 11140231, 11111231, 11285242, 11285141, 12030241, 12030231, 120871, 121252, 122131, 10085231, 100862, 1005623, 10133242, 10267242, 10267241, 10267231, 10343231, 10343241, 11089221, 11089212, 11089211, 11089221, 11111241, 11111231, 11089212, 111762, 11237231, 11243242, 11243241, 11285242, 11285241, 11237231, 11243242, 12074231, 12073231, 120931, and 121441.",".","100,030 lbs","The Peanut Butter products were manufactured using peanut butter recalled by Sunland, Inc. for salmonella.",9/24/2012,"09/24/2012",6/5/2013,"06/05/2013"
"Food",63277,"Ongoing","Pecan Deluxe Candy Company","Dallas","TX","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","CA, IA, MI, MO, NC, NV, NY, OH, PA, TX, UT, WI and Canada","F-1449-2013","Class I","Peanut Butter Crunch, 45 lb Case, Item Number 01-326-45, Manufactured by Pecan Deluxe Candy Company, 2570 Lone Star Drive, Dallas, TX 75212","Lot #s: 111752, 100781, 101562, 102312, 102662, 103432, 110402, 110401, 113191, and 120971. ",".","76,550 lbs","The Peanut Butter products were manufactured using peanut butter recalled by Sunland, Inc. for salmonella.",9/24/2012,"09/24/2012",6/5/2013,"06/05/2013"
"Food",63277,"Ongoing","Pecan Deluxe Candy Company","Dallas","TX","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","CA, IA, MI, MO, NC, NV, NY, OH, PA, TX, UT, WI and Canada","F-1448-2013","Class I","Peanut Butter Ribbon, 40 lb Pail, Item Numbers 07-012-40, 07-212-40, and 49-00100-40, Manufactured by Pecan Deluxe Candy Company, 2570 Lone Star Drive, Dallas, TX 75212","Item 07-012-40, Lots 100992, 10209241, 103361, 110381, 11117241, 11117141, 11222231, 11222241, 12030241, 10244241, 10049241, 10099231, and 10244241. Lots of 07-212-40: 102882, 120462, 10162241, 11133231, 120462, 101621, 101622, 10209141, 10209131, 10288131, 10288141, 10288231, 10349241, 10349231, 11133241, 11133231, 11176231, 11176241, 11194231, 11251231, 11251241, 12034231, 120951, 121322, 12182241, 12182132, 12182142, 12182141, 12182131, 12182231, and 12208233. Lots of 49-00100-40: 10133241, 1014715, 10133241, 1023225, 110612, 10133241, 1019625, 103072, and 1116015. ",".","262,410 lbs","The Peanut Butter products were manufactured using peanut butter recalled by Sunland, Inc. for salmonella.",9/24/2012,"09/24/2012",6/5/2013,"06/05/2013"
"Food",63277,"Ongoing","Pecan Deluxe Candy Company","Dallas","TX","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","CA, IA, MI, MO, NC, NV, NY, OH, PA, TX, UT, WI and Canada","F-1452-2013","Class I","Peanut Butter Base, 30 lb Pail, Item Numbers 08-010-30, 08-310-30, and 08-810-30, Manufactured by Pecan Deluxe Candy Company, 2570 Lone Star Drive, Dallas, TX 75212","Lot #s: 120462, 11021231, 100122, 10118241, 10118231, 1105412, 110541, 102211, 1032215, 110212, 110542, 10118231, 10118241, 102581, 11140231, 11140242, 11140241, 120462, 10118231, 12034241, 100842, 10111231, 1015515, 110742, 1115425, 112861, 112862, 1103115, 11140242, 11318142, 10111231, 100851, 110212, 11291231, 11291241, 1012525, 103332, and 103471.",".","76,170 lbs","The Peanut Butter products were manufactured using peanut butter recalled by Sunland, Inc. for salmonella.",9/24/2012,"09/24/2012",6/5/2013,"06/05/2013"
"Food",63277,"Ongoing","Pecan Deluxe Candy Company","Dallas","TX","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","CA, IA, MI, MO, NC, NV, NY, OH, PA, TX, UT, WI and Canada","F-1450-2013","Class I","Peanut Butter Fudge Ribbon, 50 lb Pail, Item Number 07-094-50, Manufactured by Pecan Deluxe Candy Company, 2570 Lone Star Drive, Dallas, TX 75212","Lot #s: 112142 ",".","3600 lbs","The Peanut Butter Ribbon and Chunky Peanut Butter Ribbon were manufactured using peanut butter recalled by Sunland, Inc. for salmonella.",9/24/2012,"09/24/2012",6/5/2013,"06/05/2013"
"Biologics",63282,"Ongoing","Ethicon, Inc.","Somerville","NJ","US","Voluntary: Firm Initiated","Letter","Nationwide and Foreign (Canada, Israel, Singapore, and Switzerland)","B-1049-13","Class III","Thrombin, Topical (Human) EvithromRx only Distributor: Johnson & Johnson Wound Management A division of Ethicon, Inc. Manufacturer: Omrix Biopharmaceuticals Ltd. 2 mL - NDC 63713-460-02 5 mL- NDC 63713-460-05","Evithrom 2mL Product Code S4602, Lot Number Q36T62K; Product Code 4602, Lot Numbers P49T05K, Q11T44J, Q2T46K, Q45T77J; Evithrom 5 mL Product Code 4605 Lot Numbers P46T84J, P50T150, Q07T23J, Q08T28K, Q23T88K, Q25T93J, Q25T94J, Q27T08J, Q30T31J, Q31T34J, Q31T360, Q32T41K, Q33T48J ",,"18","Evicel and Evithrom, manufactured with a processing deviation that potentially led to decreased potency, were distributed. ",9/27/2012,"09/27/2012",3/13/2013,"03/13/2013"
"Biologics",63282,"Ongoing","Ethicon, Inc.","Somerville","NJ","US","Voluntary: Firm Initiated","Letter","Nationwide and Foreign (Canada, Israel, Singapore, and Switzerland)","B-1048-13","Class III"," Fibrin Sealant (Human) Evicel Rx Only Sterile Disposable Single Use Distributed by: Johnson and Johnson Wound Management A division of Ethicon Inc. Johnson & Johnson Wound Management A division of ETHICON, INC. P.O. Box 151, Somerville, NJ 08876-0151 USA Manufacturer: omrix Omrix biopharmaceuticals, Ltd. MDA blood bank, Sheba Hospital Ramat-Gan POB 888, Kiryat Ono 55000 ISRAEL NDC 63713-390-55 for EVICEL Fibrin Sealant (Human) 5 mL NDC 63713-390-11 for EVICEL Fibrin Sealant (Human) 1 mL NDC 63713-390-22 for EVICEL Fibrin Sealant (Human) 2 mL","5 mL sample PRODUCT CODE S3905 LOT NUMBERS Q02F010, Q05F120, Q19F420, Q35F780, Q33F700 1 mL PRODUCT CODE 3901 LOT NUMBERS Q44F97K, Q53F350 2 mL PRODUCT CODE 3902 LOT NUMBERS Q03F030, Q09F310, Q29F610, Q44F980, Q31F640, Q35F750, Q36F820, Q46F040, Q47F050 5 mL PRODUCT CODE 3905 LOT NUMBERS P44F050 P45F100 P45F090 P46F120 P48F180 R06F130 R07F180 R07F190 R07F250 R07F260 R10F310 P50F330 R10F320 R10F330 R12F380 P48F190 P53F390 Q03F040 P50F310 Q02F010 P52F370 Q11F320 P52F360 Q02F020 Q04F090 Q04F100 Q04F110 Q05F120 Q32F660 Q05F130 Q05F140 Q06F160 Q06F170 Q07F210 Q08F280 Q08F290 Q16F400 Q08F300 Q13F340 Q33F710 Q13F350 Q14F360 Q14F370 Q15F380 Q15F390 Q19F410 Q28F560 Q19F420 Q21F470 Q21F480 Q32F670 Q31F620 Q31F630 Q22F490 R03F090 Q28F570 Q35F760 Q29F580 Q29F590 Q33F720 Q34F730 Q34F740 Q32F680 Q33F690 Q50F210 Q33F700 Q35F770 Q35F790 Q36F810 Q41F900 R01F010 R010F020 R01F030 Q41F920 Q40F880 Q41F910 Q48F090 R06F140 Q42F940 Q43F950 Q48F100 Q43F960 Q45F990 Q47F070 Q49F140 Q49F150 Q50F220 Q52F300 R03F080 Q51F280 Q52F290 R07F200 Q50F230 Q50F240 Q51F260 ",,"120","Evicel and Evithrom, manufactured with a processing deviation that potentially led to decreased potency, were distributed. ",9/27/2012,"09/27/2012",3/13/2013,"03/13/2013"
"Drugs",63285,"Ongoing","Dr. Reddy's Laboratories, Inc.","Bridgewater","NJ","US","Voluntary: Firm Initiated","Letter","Nationwide","D-179-2013","Class II","Citalopram tablets USP, 20mg, 30-count bottle, Rx only, Manufactured by Dr. Reddy's Laboratories Limited, Bachupalli, India 502 325, NDC 55111-343-30","Lot #: C201922, Exp 1/14",,"86, 093 bottles","Chemical Contamination: The product is being recalled due to complaints reporting a strong garlic odor or strong chemical smell.",8/1/2012,"08/01/2012",3/6/2013,"03/06/2013"
"Drugs",63285,"Ongoing","Dr. Reddy's Laboratories, Inc.","Bridgewater","NJ","US","Voluntary: Firm Initiated","Letter","Nationwide","D-180-2013","Class II","Citalopram tablets USP, 40mg, 30-count bottle, Rx only, Manufactured by Dr. Reddy's Laboratories Limited, Bachupalli, India 502 325, NDC 55111-344-30","Lot #: C108376, C108634, Exp 11/13",,"48, 754 bottles (C108376)/47,520 bottles (C108634)","Chemical Contamination: The product is being recalled due to complaints reporting a strong garlic odor or strong chemical smell.",8/1/2012,"08/01/2012",3/6/2013,"03/06/2013"
"Drugs",63285,"Ongoing","Dr. Reddy's Laboratories, Inc.","Bridgewater","NJ","US","Voluntary: Firm Initiated","Letter","Nationwide","D-178-2013","Class II","Citalopram tablets USP, 10mg, 30-count bottle, Rx only, Manufactured by Dr. Reddy's Laboratories Limited, Bachupalli, India 502 325, NDC 55111-342-30","Lot #: C201028, Exp 12/13",,"27,805 bottles","Chemical Contamination: The product is being recalled due to complaints reporting a strong garlic odor or strong chemical smell.",8/1/2012,"08/01/2012",3/6/2013,"03/06/2013"
"Biologics",63293,"Terminated","Florida Blood Services, Inc.","Pensacola","FL","US","Voluntary: Firm Initiated","Telephone","Florida","B-1148-13","Class II","Red Blood Cells","11631200368800Q; ",,"1","Blood product, collected from a therapeutic donor with polycythemia vera, was distributed",9/17/2012,"09/17/2012",5/22/2013,"05/22/2013"
"Drugs",63305,"Ongoing","New England Compounding Center","Framingham","MA","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Nationwide","D-109-2013","Class I","Methylprednisolone Acetate (PF) 40 mg/ml Injection, supplied in 1 mL, 2 mL and 5 mL vials, manufactured by New England Compounding Center, Framingham, MA ","All lot codes",".","9062 vials","Non-Sterility",9/26/2012,"09/26/2012",1/9/2013,"01/09/2013"
"Drugs",63305,"Ongoing","New England Compounding Center","Framingham","MA","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Nationwide","D-113-2013","Class II","Betamethasone Sodium Phosphate 6 mg/mL P Injection, Betamethasone Sodium Phosphate 6 mg/mL PF Injection, Betamethasone Sodium Phosphate 8 mg/mL PF Injection, Betamethasone Sodium Phosphate 12 mg/mL PF Injection, manufactured by New England Compounding Center, Framingham, MA","All lot codes",".",,"Lack of Assurance of Sterility",9/26/2012,"09/26/2012",1/9/2013,"01/09/2013"
"Drugs",63305,"Ongoing","New England Compounding Center","Framingham","MA","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Nationwide","D-121-2013","Class II","Lidocaine 1% PF, 2% PF, and 4% PF, in 1 mL, 2 mL, 5 mL, and 10 mL vials, manufactured by New England Compounding Center, Framingham, MA","All lot codes",".","3,321 vials","Lack of Assurance of Sterility",9/26/2012,"09/26/2012",1/9/2013,"01/09/2013"
"Drugs",63305,"Ongoing","New England Compounding Center","Framingham","MA","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Nationwide","D-119-2013","Class II","Isovue 200 mg/mL PF and 300 mg/mL PF, Vials, manufactured by New England Compounding Center, Framingham, MA","All lot codes",".","7055 vials","Lack of Assurance of Sterility",9/26/2012,"09/26/2012",1/9/2013,"01/09/2013"
"Drugs",63305,"Ongoing","New England Compounding Center","Framingham","MA","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Nationwide","D-118-2013","Class II","Hyaluronidase 150 u/ml PF, 1 mL, 5 mL, and 10 mL vials, manufactured by New England Compounding Center, Framingham, MA","All lot codes",".","10,865 vials","Lack of Assurance of Sterility",9/26/2012,"09/26/2012",1/9/2013,"01/09/2013"
"Drugs",63305,"Ongoing","New England Compounding Center","Framingham","MA","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Nationwide","D-117-2013","Class II","Glycerin 100% PF, 1mL, 2 mL, and 5 mL vials, manufactured by New England Compounding Center, Framingham, MA ","All lot codes",".","165 vials","Lack of Assurance of Sterility",9/26/2012,"09/26/2012",1/9/2013,"01/09/2013"
"Drugs",63305,"Ongoing","New England Compounding Center","Framingham","MA","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Nationwide","D-122-2013","Class II","Omnipaque 240mg/mL PF, 300mg/mL PF, in 3 mL, 5 mL, and 10 mL, vials, manufactured by New England Compounding Center, Framingham, MA","All lot codes",".","8919 vials","Lack of Assurance of Sterility",9/26/2012,"09/26/2012",1/9/2013,"01/09/2013"
"Drugs",63305,"Ongoing","New England Compounding Center","Framingham","MA","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Nationwide","D-120-2013","Class II","Lidocaine/Dextrose 5%/7.5% PF, manufactured by New England Compounding Center, Framingham, MA","All lot codes",".",,"Lack of Assurance of Sterility",9/26/2012,"09/26/2012",1/9/2013,"01/09/2013"
"Drugs",63305,"Ongoing","New England Compounding Center","Framingham","MA","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Nationwide","D-110-2013","Class I","Methylprednisolone Acetate 40 mg/mL Injection, Preserved, supplied in 5 mL and 10 mL vials, manufactured by New England Compounding Center, Framingham, MA","All lot codes",".","5130 vials","Non-Sterility",9/26/2012,"09/26/2012",1/9/2013,"01/09/2013"
"Drugs",63305,"Ongoing","New England Compounding Center","Framingham","MA","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Nationwide","D-114-2013","Class II","Bupivacaine 0.25% PF, Bupivacaine 0.5% PF, and Bupivacaine 0.75% PF, manufactured by New England Compounding Center, Framingham, MA ","All lot codes",".",,"Lack of Assurance of Sterility",9/26/2012,"09/26/2012",1/9/2013,"01/09/2013"
"Drugs",63305,"Ongoing","New England Compounding Center","Framingham","MA","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Nationwide","D-111-2013","Class I","Methylprednisolone Acetate 80 mg/mL Injection, Preserved, supplied in 5 mL and 10 mL vials, manufactured by New England Compounding Center, Framingham, MA","All lot codes",".","3822 vials","Non-Sterility",9/26/2012,"09/26/2012",1/9/2013,"01/09/2013"
"Drugs",63305,"Ongoing","New England Compounding Center","Framingham","MA","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Nationwide","D-123-2013","Class II","Saline 10% and 3%, in 5 mL and 10 mL vials, manufactured by New England Compounding Center, Framingham, MA","All lot codes",".","54 vials","Lack of Assurance of Sterility",9/26/2012,"09/26/2012",1/9/2013,"01/09/2013"
"Drugs",63305,"Ongoing","New England Compounding Center","Framingham","MA","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Nationwide","D-124-2013","Class II","Triamcinolone 10 mg/mL P, 40mg/mL P, 40mg/mL PF and 80 mg/mL PF in 1 mL, 2 mL, 5 mL, and 10 mL vials, manufactured by New England Compounding Center, Framingham, MA","All lot codes",".","56,655 vials","Lack of Assurance of Sterility",9/26/2012,"09/26/2012",1/9/2013,"01/09/2013"
"Drugs",63305,"Ongoing","New England Compounding Center","Framingham","MA","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Nationwide","D-112-2013","Class II","Betamethasone Repository 6 mg/mL PF Injection and Betamethasone Repository 6 mg/mL P Injection, manufactured by New England Compounding Center, Framingham, MA","All lot codes",".",,"Lack of Assurance of Sterility",9/26/2012,"09/26/2012",1/9/2013,"01/09/2013"
"Drugs",63305,"Ongoing","New England Compounding Center","Framingham","MA","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Nationwide","D-115-2013","Class II","Clonidine 100 mcg/mL PF, 1mL and 2 mL vials, manufactured by New England Compounding Center, Framingham, MA ","All lot codes",".","2747 vials","Lack of Assurance of Sterility",9/26/2012,"09/26/2012",1/9/2013,"01/09/2013"
"Drugs",63305,"Ongoing","New England Compounding Center","Framingham","MA","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Nationwide","D-116-2013","Class II","Dexamethasone Sodium Phosphate 4 mg/mL vials PF, 6 mg/mL PF vials, and 8 mg/mL PF vials, manufactured by New England Compounding Center, Framingham, MA ","All lot codes",".","20 vials","Lack of Assurance of Sterility",9/26/2012,"09/26/2012",1/9/2013,"01/09/2013"
"Drugs",63305,"Ongoing","New England Compounding Center","Framingham","MA","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Nationwide","D-108-2013","Class I","Methylprednisolone Acetate (PF) 80 mg/ml Injection, supplied in 1 mL, 2 mL and 5 mL vials, manufactured by New England Compounding Center, Framingham, MA ","All Lot codes ",".","23,897 vials","Non-Sterility",9/26/2012,"09/26/2012",1/9/2013,"01/09/2013"
"Veterinary",63308,"Ongoing","Premium Nutritional Products Inc","Shawnee","KS","US","Voluntary: Firm Initiated","E-Mail","AZ, TX, NJ, PA, CA, MI, FL, WI, WA, PA, NC, OH, NY, IL, NC, KY, UT, OK, MO, VA, IA, OR, OH, AL, NH, GA, LA, KS","V-161-2013","Class I","ZuPreem FruitBlend with Natural Fruit Flavors, Premium Daily Bird Food for Macaws, Cockatoos, Amazons and other Large parrots. Packaged in 2 lb, 3.5 lb and 12 lb stand-up plastic pouches; also packaged in 17.5 lb and 35 lb bulk paper bags.","Lot 598405072 UPC 762177840208, Exp date: 11/30/2013 (2 lbs package) UPC 762177840307, Exp date: 11/30/2013 (3.5 lbs package) UPC 762177841205, Exp date: 11/30/2013 (12 lbs package) UPC 76211841700, Exp date: 11/13 (17.5 lbs package) UPC 762177843506, Exp date: 11/13 (35 lbs package)",,"27,665/units","The products contain elevated calcium levels.",9/27/2012,"09/27/2012",5/22/2013,"05/22/2013"
"Veterinary",63308,"Ongoing","Premium Nutritional Products Inc","Shawnee","KS","US","Voluntary: Firm Initiated","E-Mail","AZ, TX, NJ, PA, CA, MI, FL, WI, WA, PA, NC, OH, NY, IL, NC, KY, UT, OK, MO, VA, IA, OR, OH, AL, NH, GA, LA, KS","V-160-2013","Class I","ZuPreem FruitBlend with Natural Fruit Flavors, Premium Daily Bird Food, for Conures, Amazons, Greys, Pionus, Caiques, Senegals and other medium to large parrots. Packaged in 2 lb, 3.5 lb and 12 lb stand-up plastic pouches; also packaged in 17.5 lb and 35 lb bulk paper bags.","Lot 598405052 UPC 762177830209, Exp date: 11/30/2013 (2 lbs package) UPC 762177830308, Exp date: 11/30/2013 (3.5 lbs package) UPC 762177831206, Exp date: 11/30/2013 (12 lbs package) UPC 762177831701, Exp date: 11/13 (17.5 lbs package) UPC 762177833507, Exp date: 11/13 (35 lbs package)",,"33,059/units","The products contain elevated calcium levels.",9/27/2012,"09/27/2012",5/22/2013,"05/22/2013"
"Food",63311,"Ongoing","Whole Foods Market","Austin","TX","US","Voluntary: Firm Initiated","Other","FL and CA","F-1198-2013","Class I","Treasure Trove Mix, sold from Whole Foods Market Bulk Bins PLU 6922","All product sold through the firm's self serve bins between May 1 and September 27th.",,"431 lbs. ","The bulk Peanut Butter Power Chews and Treasure Trove Mix have the potential to be contaminated with Salmonella. The products were manufactured by Sunridge Farms/Falcon Trading who was supplied peanut butter by Sunland, Inc.",9/26/2012,"09/26/2012",3/20/2013,"03/20/2013"
"Food",63311,"Ongoing","Whole Foods Market","Austin","TX","US","Voluntary: Firm Initiated","Other","FL and CA","F-1197-2013","Class I","Peanut Butter Power Chews sold as a bulk item through Whole Foods Market self serve bins, PLU 9663","All product sold through the firm's self serve bins between May 1 and September 27th.",,"18 lbs.","The bulk Peanut Butter Power Chews and Treasure Trove Mix have the potential to be contaminated with Salmonella. The products were manufactured by Sunridge Farms/Falcon Trading who was supplied peanut butter by Sunland, Inc.",9/26/2012,"09/26/2012",3/20/2013,"03/20/2013"
"Devices",63319,"Ongoing","Vycor Medical, Inc.","Boca Raton","FL","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Worldwide Distribution - USA (Nationwide) in the states of TX, IL, NJ, FL, OH, PA and (International) in the country of Japan.","Z-0673-2013","Class I","Vycor Medical ViewSite Brain Access System 17mm/ 11mm / 5cm Device***STERILE*** Product Usage: The Vycor Viewsite Brain Access System (VBAS) has been designed to serve as a self-retaining retractor system for brain tissue. It is comprised of an introducer and a working channel port that are secured by a spring-loaded latch. Each device allows for the gentle retraction of tissue, visualization of the surgical site and for the smooth manipulation of introduced instruments. The range of device sizes (width and length) provides various working channel sizes.","Model # TC171105 Lot # VM83450",".","3000 devices ","Vycor Medical recalled their VBAS (Vycor Viewsite Brain Access System) because an unidentified black fiber was found on the device.",8/21/2012,"08/21/2012",1/23/2013,"01/23/2013"
"Biologics",63326,"Terminated","Community Blood Centers of Florida, Inc.","Miami","FL","US","Voluntary: Firm Initiated","Letter","Florida","B-0283-13","Class II","Platelets Pooled Leukocytes Reduced Irradiated","2930687; ",".","1","Blood products, which were collected from a donor in which donor suitability was not adequately determined, were distributed.",8/18/2012,"08/18/2012",1/16/2013,"01/16/2013"
"Biologics",63326,"Terminated","Community Blood Centers of Florida, Inc.","Miami","FL","US","Voluntary: Firm Initiated","Letter","Florida","B-0282-13","Class II","Fresh Frozen Plasma","2723207; ",".","1","Blood products, which were collected from a donor in which donor suitability was not adequately determined, were distributed.",8/18/2012,"08/18/2012",1/16/2013,"01/16/2013"
"Biologics",63326,"Terminated","Community Blood Centers of Florida, Inc.","Miami","FL","US","Voluntary: Firm Initiated","Letter","Florida","B-0281-13","Class II","Red Blood Cells","2723207; ",".","1","Blood products, which were collected from a donor in which donor suitability was not adequately determined, were distributed.",8/18/2012,"08/18/2012",1/16/2013,"01/16/2013"
"Biologics",63327,"Terminated","Community Blood Centers of Florida, Inc.","Lauderhill","FL","US","Voluntary: Firm Initiated","Letter","Tennessee; Switzerland; Florida","B-0279-13","Class III","Blood and Blood Products for Reprocessing","W036811262717; W036810243696; W036810039414; W036809359200; W036809216741; 2479070; ",".","6","Blood products, collected from a donor in whom donor suitability was not adequately determined, were distributed.",8/17/2012,"08/17/2012",1/16/2013,"01/16/2013"
"Biologics",63327,"Terminated","Community Blood Centers of Florida, Inc.","Lauderhill","FL","US","Voluntary: Firm Initiated","Letter","Tennessee; Switzerland; Florida","B-0275-13","Class II","Cryoprecipitated AHF, Pooled","W036811822350; ",".","1","Blood products, collected from a donor in whom donor suitability was not adequately determined, were distributed.",8/17/2012,"08/17/2012",1/16/2013,"01/16/2013"
"Biologics",63327,"Terminated","Community Blood Centers of Florida, Inc.","Lauderhill","FL","US","Voluntary: Firm Initiated","Letter","Tennessee; Switzerland; Florida","B-0280-13","Class II","Red Blood Cells","W036811262717; W036810039414; W036809359200; W036809216741; 2243062; 2479070; W036810243696; ",".","7","Blood products, collected from a donor in whom donor suitability was not adequately determined, were distributed.",8/17/2012,"08/17/2012",1/16/2013,"01/16/2013"
"Biologics",63327,"Terminated","Community Blood Centers of Florida, Inc.","Lauderhill","FL","US","Voluntary: Firm Initiated","Letter","Tennessee; Switzerland; Florida","B-0278-13","Class II","Platelets Pooled Leukocytes Reduced","W036810821967; W036809821585; W036809813222; 2911209; ",".","4","Blood products, collected from a donor in whom donor suitability was not adequately determined, were distributed.",8/17/2012,"08/17/2012",1/16/2013,"01/16/2013"
"Biologics",63327,"Terminated","Community Blood Centers of Florida, Inc.","Lauderhill","FL","US","Voluntary: Firm Initiated","Letter","Tennessee; Switzerland; Florida","B-0277-13","Class II","Cryoprecipitated AHF","W036809216741; 2479070; ",".","2","Blood products, collected from a donor in whom donor suitability was not adequately determined, were distributed.",8/17/2012,"08/17/2012",1/16/2013,"01/16/2013"
"Biologics",63327,"Terminated","Community Blood Centers of Florida, Inc.","Lauderhill","FL","US","Voluntary: Firm Initiated","Letter","Tennessee; Switzerland; Florida","B-0276-13","Class II","Fresh Frozen Plasma","2243062; ",".","1","Blood products, collected from a donor in whom donor suitability was not adequately determined, were distributed.",8/17/2012,"08/17/2012",1/16/2013,"01/16/2013"
"Devices",63355,"Ongoing","Stryker Communications, Inc.","Flower Mound","TX","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution - USA (nationwide) and Internationally to Australia, Japan, Taiwan, Canada, United Kingdom, France, Netherlands, Spain, Mexico, India, Korea, Singapore, New Zealand, Hong Kong, Philippines and Brazil.","Z-0657-2013","Class II","(l) Visum Halogen Surgical Light, (2) Visum LED Surgical Light, (3) Stryker Flat Panel & Navigation ArmThe Spring Arm Circlip is part of the Stryker Spring Arm used in multiple configurations as a component of the (1)Visum Halogen Surgical Light, (2)Visum LED Surgical Light, and (3)Stryker Flat Panel & Navigation Arm. The Spring Arm that is subject to this field action suspends loads, is a conduit for power/data, and facilitates multi-directional movement. The Spring Arms that have been identified within scope are replacement parts that have potentially been serviced incorrectly.","Code Number and Product Name: 0682000112-SPRING ARM, LIGHT 12-18KG, 0682000211 - FLAT PANEL SPRING ARM, ONDAL SUSPENSION, 15-21KG, 0682000212 - FLAT PANEL SPRING ARM, ONDAL SUSP., 12-18KG, 0682000226 - SPRING ARM,3.5-7KG,NAVIGATION, 0682000228 - SPRING ARM, LIGHT 9-15KG, 0682001062 - PKG EDS LIGHT SUSPENSION CENTRAL AXIS 5P/FP, 0682001270 - 9-POLE SPRING ARM, AC 2000,15-21 KG, 0682001274 - 5-POLE SPRING ARM AC 2000 15-21 KG, 0682400034 - FLAT PANEL SPRING ARM, EDS SUSPENSION, 15-21KG, 0682400059 - UNIVERSAL YOKE SPRING ARM RETROFIT KIT, 06824000591 - UNIVERSAL YOKE & SPRING ARM RETROFIT KIT, INT, 0682400151 - LOW CEILING SPRING ARM, 5P SIDE MOUNT, 0682400152 - LOW CEILING SPRING ARM, 9P SIDE MOUNT, 0682400169 - 5-POLE SPRING ARM AC 2000 9-15KG, CARDINAL, 0682400207 - STANDARD SPRING ARM WITH BEARING, 5P, 0682400208 - STANDARD SPRING ARM WITH BEARING, 9P, and 0682400365 - FLAT PANEL SPRING ARM WITH ERA ADAPTER BEARING.",".","United States: 1,082 units and Outside United States: 199 units","Stryker has become aware that there is a low likelihood of incomplete engagement of the Spring Arm Circlip during service or replacement of the Spring Arm. If the Spring Arm Circlip is not fully seated, the Spring Arm could separate and fall along with the surgical lights or monitors mounted to the end of the Spring Arm. To date, there have been no serious injuries reported from the incomplete engagement of the Spring Arm Circlip.",9/25/2012,"09/25/2012",1/16/2013,"01/16/2013"
"Food",63356,"Ongoing","Whole Foods Market","Austin","TX","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","TX","F-1447-2013","Class I","Peanut Sesame Noodles Dist. by Whole Foods Market, UPC 222099604192","All product with either a sell by date of 10/1/12 or 10/2/12 or a sold on date of 09/27/12 or 9/28/12.",".",,"The products were manufactured using peanuts supplied by Sunland, Inc. and have the potential to be contaminated with Salmonella.",10/1/2012,"10/01/2012",5/29/2013,"05/29/2013"
"Food",63356,"Ongoing","Whole Foods Market","Austin","TX","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","TX","F-1446-2013","Class I","Chicken Spring Rolls Dist. by Whole Foods Market, UPC 225757203997","All product with a sell by date of 10/1/12 or 10/2/12.",".",,"The products were manufactured using peanuts supplied by Sunland, Inc. and have the potential to be contaminated with Salmonella.",10/1/2012,"10/01/2012",5/29/2013,"05/29/2013"
"Drugs",63364,"Ongoing","Hospira Inc.","Lake Forest","IL","US","Voluntary: Firm Initiated","Letter","Nationwide","D-922-2013","Class I","0.9% Sodium Chloride Injection, USP, 100 mL flexible container, Rx only, Hospira, Inc. Lake Forest, IL 60045 --- NDC 0409-7984-23 ","Lot Number 05-201-JT, Expiration Date 1MAY2013",,"264,432 bags","Presence of Particulate Matter; product may contain fibrous material",8/31/2012,"08/31/2012",9/4/2013,"09/04/2013"
"Food",63366,"Ongoing","Nature's Candy, Inc.","Fredericksburg","TX","US","Voluntary: Firm Initiated","E-Mail","CA and CO","F-1459-2013","Class I","Maple Macadamia Nuts, 25 lb bulk boxes","Lot #s 7241, 7242, and 7243",".","20 boxes","The macadamia nuts have the potential to be contaminated with Salmonella.",9/20/2012,"09/20/2012",6/5/2013,"06/05/2013"
"Devices",63367,"Ongoing","Beckman Coulter Inc.","Brea","CA","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution - USA Nationwide and the countries of Canada, Australia, Belgium, Czech Republic, France, French Polynesia, Germany, Greece, Hong Kong, Ireland, Italy, Japan, Jordon, Kuwait, Lebanon, Malawi, Morocco, Namibia, Netherlands, oman, Panama, Paraguay, Qatar, Reunion, Singapore, Slovakia, South Africa, Spain, Sweden, Switzerland, Taiwan, Thailand, Tunisia, Turkey, United Arab Emirates, United Kingdom","Z-1400-2013","Class II","Synchron LX System(s) and UniCel DxC 600/800 System(s) Lactate Reagent, Part Number: A95550 Product Usage: Lactate (LACT) reagent, when used in conjunction with Synchron LX System(s), UniCel DxC 600/800 System(s) and Synchron Systems Multi Calibrator, is intended for the quantitative determination of lactate concentration in human plasma and cerebrospinal fluid (CSF).","Lot Number: M206209",".","8,774 units","Beckman Coulter initiated the recall for the Lactate Assay (LACT) Lot M206209 as they received a customer complaint of error message (RXN RATE HI), i.e. no numerical values reported for samples containing Lactate concentration greater than 6.5 mmol/L.",4/17/2013,"04/17/2013",6/5/2013,"06/05/2013"
"Biologics",63375,"Terminated","American National Red Cross","Louisville","KY","US","Voluntary: Firm Initiated","FAX","Indiana; Kentucky","B-0401-13","Class II","Plasma Frozen within 24 hours (FP24)","24GV54136; ",".","1 unit","Blood products, which were collected from a donor in which donor suitability was not adequately determined, were distributed.",8/22/2012,"08/22/2012",1/30/2013,"01/30/2013"
"Biologics",63375,"Terminated","American National Red Cross","Louisville","KY","US","Voluntary: Firm Initiated","FAX","Indiana; Kentucky","B-0400-13","Class II","Red Blood Cells Leukocytes Reduced Irradiated","24GV54136; ",".","1 unit","Blood products, which were collected from a donor in which donor suitability was not adequately determined, were distributed.",8/22/2012,"08/22/2012",1/30/2013,"01/30/2013"
"Devices",63390,"Ongoing","Lansinoh Laboratories Inc","Alexandria","VA","US","Voluntary: Firm Initiated","Letter","Nationwide Distribution, including the states of TX, CA, NJ, NY, SD, RI, WV, IL PA, NC and MN.","Z-0784-2013","Class II","THERA PEARL 3-in-1 BREAST THERAPY, 2 hot and cold packs in plastic box. The Thera Pearl 3-in-1 Breast Therapy is a reusable therapeutic hot and cold pack for use with pain, swelling, engorgement, plugged ducts or mastitis associated with breast feeding or to help encourage let-down while using a breast pump.","Lot Numbers 100/12/01, 116/12/01, 108/12/01, 109/12/01, 149/12/01",,"51,472 units","The Spanish translation on the Instructions for Use (IFU) insert and product package for hot and cold packs has incorrect heating instructions which would cause product to over heat. ",8/14/2012,"08/14/2012",2/13/2013,"02/13/2013"
"Devices",63392,"Ongoing","Philips Medical Systems (Cleveland) Inc","Cleveland","OH","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution - USA ( nationwide) including the states of AK, AL, AR, AZ, CA, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, PR, RI, SC, TN, TX, VA, WA, WV and WY, and the countries of Albania, Algeria, Argentina, Australia, Austria, Belarus, Belgium, Bolivia, Brazil, Canada, China, Colombia, Denmark, Dominican Republic, Ecuador, Egypt, France, Germany, Ghana, Gibraltar, Greece, Hungary, India, Indonesia, Iran, Iraq, Ireland, Israel, Italy, Japan, Jordan, Kuwait, Lebanon, Libyan Arab Jamahiriya, Lithuania, Malaysia, Mexico, Morocco, Netherlands, New Zealand, Nicaragua, Nigeria, Norway, Panama, Peru, Philippines, Poland, Portugal, Romania, Russia, Saudi Arabia, Singapore, Slovakia, South Korea, Spain, Sri Lanka, Sweden, Switzerland, Syrian Arab Republic, Taiwan, Thailand, Turkey, Turkmenistan, United Arab Emirates, United Kingdom, Venezuela, Viet Nam & Yemen.","Z-0786-2013","Class II","Mx8000 IDT Whole Body Computed Tomography X-ray system Distributed by Philips Medical Systems, Highland Heights, OH 44143 The Brilliance Scanner are computed Tomography X-ray systems with multi-slice capability of up to 16 slices,which are intended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission data taken at different angles and planes.","1. Brilliance CT 16 slice (water): System Code #, 728245, Serial #s:2506, 2518, 2555, 2558, 2559, 2561, 2561, 2562, 2564, 2567, 2573, 2576, 2578, 2582, 2583, 2584, 2585, 2586, 2587, 2589, 2590, 2592, 2594, 2596, 2597, 3014, 3051, 3090, 3091, 3105, 3151, 3217, 3235, 3272, 3287, 3303, 3312, 3335, 3338, 3339, 3340, 3341, 3342, 3343, 3344, 3345, 3346, 3347, 3348, 3349, 3350, 3351, 3352, 3353, 3354, 3355, 3356, 3357, 3358, 3359, 3359, 3360, 3361, 3362, 3363, 3364, 3365, 3366, 3367, 3368, 3369, 3370, 3371, 3372, 3373, 3374, 3375, 3376, 3377, 3378, 3379, 3380, 3381, 3382, 3383, 3384, 3385, 3386, 3387, 3388, 3389, 3390, 3391, 3392, 3393, 3394, 3395, 3396, 3397, 3398, 3399, 3400, 3401, 3402, 3403, 3404, 3405, 3406, 3407, 3408, 3409, 3410, 3411, 3412, 3413, 3414, 3415, 3416, 3417, 3418, 3419, 3420, 3421, 3422, 3423, 3424, 3425, 3426, 3427, 3428, 3429, 3430, 3431, 3432, 3433, 3434, 3435, 3435, 3436, 3437, 3438, 3439, 3440, 3441, 3442, 3443, 3444, 3445, 3446, 3447, 3448, 3449, 3450, 3451, 3452, 3453, 3454, 3455, 3456, 3457, 3458, 3459, 3460, 3461, 3462, 3463, 3464, 3465, 3466, 3467, 3468, 3469, 3470, 3471, 3472, 3473, 3474, 3475, 3476, 3477, 3478, 3479, 3480, 3481, 3482, 3483, 3484, 3485, 3486, 3487, 3488, 3489, 3490, 3491, 3492, 3493, 3494, 3495, 3496, 3497, 3498, 3499, 3500, 3501, 3502, 3503, 3504, 3505, 3506, 3507, 3508, 3509, 3510, 3511, 3512, 3513, 3514, 3515, 3516, 3517, 5010, 5077, 5119, 6095, 9701, 9708, 9715, 9716, 9718, 9719, 9724, 9728, 9729, 9732, 9741, 9743, 9745, 9746, 9749, 9750, 9754, 9760, 9764, 9771, 9776, 9778, 9780, 9785, 9787, 9788, 9789, 9790, 9794, 9797, 9800, 9801, 9806, 9808, 9810, 9999 & 111111. 2. Brilliance CT 10 slice (water): System Code #, 728250, Serial #s: 2554, 2555, 2556, 2557, 2558, 2559, 2560, 2561, 2562, 2563, 2564, 2565, 2566, 2567, 2568, 2569, 2570, 2571, 2572, 2573, 2574, 2575, 2576, 2577, 2578, 2579, 2580, 2581, 2582, 2583, 2585, 2586, 2587, 2588, 2589, 2590, 2591, 2592, 2593, 2594, 2595, 2596, 2597, 2598, 9704, 9708, 9738 & 9741. 3. Brilliance CT 6 slice (water): System Code #, 7",,"1,474 Units","The low contrast pins in the Image Quality (IQ) phantom deteriorates over time. This prevents the customers from doing the Daily Image Quality Checks as defined in the current Instructions for Use (IfU).",9/18/2012,"09/18/2012",3/6/2013,"03/06/2013"
"Devices",63393,"Ongoing","Philips Medical Systems (Cleveland) Inc","Cleveland","OH","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution-USA including the states of AZ, CA, CO, IL, IL, IN, MA, ME, MI, MO, NC, NJ, NY, OR, TN, TX, VA and WI and the countries of Austria, Canada, China, France, India, Ireland, Italy, Japan, Netherlands, Norway, Spain, Switzerland, Thailand and United Kingdom.","Z-0675-2013","Class II","Computed Tomography X-Ray System Brilliance Workspace Portal, Model #728269 Philips Medical Systems, Highland Heights, OH. The Brilliance Workspace Portal is a component of the Computed Tomography X-Ray System that is intended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission data taken at different angles and planes. The portal (together with the scanner) provides image processing and display through software applications that process, analyze, display, quantify and interpret medical images/data.","Model #728269; Serial #s: 79906, 79921, 79927, 79937, 80007, 80026, 80031, 80040, 80058, 80062, 80066, 80069, 80087, 80110, 80121, 80155, 80167, 80168, 80169, 80174, 80192, 80193, 80195, 80201, 80208, 80209, 80219, 80227, 80228, 80230, 80252, 80258, 80266, 80280, 80289, 80293, 80294, 80315, 80322, 80328, 80333, 80340, 80341, 80348, 80360, 80375, 80385, 80387, 80394, 80398, 80416, 80421, 80422, 80429, 80447, 80451, 80460, 80474, 80482, 80484, 80485, 80492, 80497, 80505, 80516, 80578, 80585, 80591, 80629, 80646, 80658, 80681, 80704, 80709, 80711, 80720, 80723, 80743, 80749, 80751, 80831, 80835, 80866, 80878, 80908, 80909, 80911, 80914, 80916, 80930, 80931, 80944, 80974, 80992, 80999, 81023, 81025, 81034, 81045, 81071, 81099, 81101, 81107, 81117, 81126, 81136, 95382 & 95592.",".","108 units","Philips was notified that when performing post processing with the Brilliance Workspace Portal platform with software versions 2.6.1.4, the coronary arteries in the rendered image are segmented automatically. However, the center line is not extracted or highlighted upon hovering and making it impossible to activate the vessel and choose the appropriate name (label) from the drop-down menu.",9/11/2012,"09/11/2012",1/23/2013,"01/23/2013"
"Devices",63394,"Ongoing","Philips Medical Systems (Cleveland) Inc","Cleveland","OH","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution--US (nationwide) including the states of AR, OH, OR, PA, TX VA & WI., and the countries of Algeria, Australia, Brazil, China, Ecuador, Finland, France, Germany, Hong Kong, India, Italy, Lebanon, Libyan Arab Jamahiriya, Russia, South Korea & United Kingdom","Z-0479-2013","Class II","Computed Tomography X-Ray System, Extended Brilliance Workspace (EBW), Model #728260 Philips Healthcare, Highland Heights, OH The Extended Brilliance Workspace (EBW) is a component of the Computed Tomography X-Ray System that is intended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission data taken at different angles and planes. ","Model #728260, Serial #s, 12876, 13924, 13994, 13996, 14104, 14116, 14677, 14682, 14694, 14695, 14702, 14707, 14710, 14727, 14728, 14730, 14824, 14840, 14926, 14930, 14932, 14940, 15008, 15015, 15017, 15023, 15036, 15081, 15085, 15146, 15329, 15354, 15393, 15397, 15398, 15399, 15400, 15401, 15402, 15403, 15451, 15453, 15550, 15551, 15552, 15553, 15554, 15555, 15556, 15557, 15558, 15559, 15560, 15561, 15562, 15563, 15564, 15565, 15566, 15567, 15568, 15569, 15570, 15571, 15572, 15573, 15574, 15575, 15576, 15577, 15578, 15579, 15580, 15581, 15582, 15583, 15584, 15585, 15586, 15587, 15588, 15589, 15590, 15591, 15592, 15593, 15594, 15595, 15596, 15597, 15598, 15599, 15600, 15601, 15602, 15603, 15604, 15605, 15606, 15607, 15608, 15609, 15610, 15611, 15612, 15613, 15614, 15615, 15616, 15617, 15618, 15619, 15620, 15621, 15622, 15623, 15624, 15625, 15626, 15627, 15628, 15629, 15630, 15631, 15632, 15633, 15634, 15635, 15636, 15637, 15638, 15639, 15640, 15641, 15642, 15643, 15644, 15645, 15646, 15647, 15648, 15649, 15650, 15651, 15652, 15653, 15654, 15655, 15656, 15657, 15658, 15659, 15660, 15661, 15662, 15663, 15664, 15665, 15666, 15667, 15668, 15669, 15670, 15671, 15672, 15673, 15674, 15675, 15676, 15677, 15678, 15679, 15680, 15681, 15682, 15683, 15684, 15685, 15686, 15687, 15689, 15690, 15691, 15692, 15694, 15695, 15696, 15697, 15698, 15699, 15700, 15701, 15702, 15703, 15704, 15705, 15706, 15707, 15708, 15709, 15710, 15711, 15712, 15713, 15714, 15715, 15716, 15717, 15718, 15719, 15720, 15721, 15722, 15723, 15724, 15725, 15726, 15727, 15728, 15729, 15730, 15731, 15732, 15734, 15735, 15736, 15737, 15753, 15754, 15755, 15756, 15757, 15758, 15760, 15761, 15762, 15763, 15764, 15765, 15766, 15767, 15768, 15770, 15771, 15772, 15800, 15801, 15802, 15803, 15804, 15805, 15806, 15807, 15808, 15809, 15810, 15811, 15812, 15813, 15814, 15818, 15820, 15821, 15826, 15827, 15828, 15829, 15830, 15831, 15832, 15834, 15835 & 15900.",".","265 units","Philips is issued a Field Change Order to update Extended Brilliance Workspace (EBW) systems to software version 4.5.5. The update will provide a number of improvements to address nonhazardous reliability issues which will improve the overall quality and functionality of the EBW.",9/28/2012,"09/28/2012",1/2/2013,"01/02/2013"
"Biologics",63398,"Terminated","Puget Sound Blood Center and Program","Seattle","WA","US","Voluntary: Firm Initiated","Letter","Washington; California","B-0264-13","Class II","Red Blood Cells","W141610173064; ",".","1","Blood products, collected from donors, whose suitability to donate was not adequately determined, were distributed.",9/6/2012,"09/06/2012",1/16/2013,"01/16/2013"
"Biologics",63398,"Terminated","Puget Sound Blood Center and Program","Seattle","WA","US","Voluntary: Firm Initiated","Letter","Washington; California","B-0262-13","Class II","Red Blood Cells Leukocytes Reduced Irradiated","W141610180553; ",".","1","Blood products, collected from donors, whose suitability to donate was not adequately determined, were distributed.",9/6/2012,"09/06/2012",1/16/2013,"01/16/2013"
"Biologics",63398,"Terminated","Puget Sound Blood Center and Program","Seattle","WA","US","Voluntary: Firm Initiated","Letter","Washington; California","B-0263-13","Class II","Red Blood Cells Leukocytes Reduced","W141610178698; ",".","1","Blood products, collected from donors, whose suitability to donate was not adequately determined, were distributed.",9/6/2012,"09/06/2012",1/16/2013,"01/16/2013"
"Biologics",63414,"Terminated","LifeShare Blood Centers","Shreveport","LA","US","Voluntary: Firm Initiated","FAX","Arkansas","B-0197-13","Class II","Red Blood Cells Leukocytes Reduced","W036512094817",".","1 unit","Blood product, collected from a donor who traveled to an area considered endemic for malaria, was distributed.",9/11/2012,"09/11/2012",1/16/2013,"01/16/2013"
"Biologics",63415,"Terminated","LifeShare Blood Centers","Shreveport","LA","US","Voluntary: Firm Initiated","FAX","Louisiana","B-0198-13","Class III","Cryoprecipitated AHF, Pooled","W036512061595",".","1 unit","Blood product, which reached an unacceptable temperature during storage, was distributed.",8/21/2012,"08/21/2012",1/16/2013,"01/16/2013"
"Biologics",63416,"Terminated","LifeShare Blood Centers","Lake Charles","LA","US","Voluntary: Firm Initiated","FAX","Louisiana, Texas","B-0314-13","Class II","Fresh Frozen Plasma","W036512045868",".","1 unit","Blood products, collected from a donor who was at risk for variant Creutzfeldt-Jakob Disease (vCJD), were distributed.",9/4/2012,"09/04/2012",1/16/2013,"01/16/2013"
"Biologics",63416,"Terminated","LifeShare Blood Centers","Lake Charles","LA","US","Voluntary: Firm Initiated","FAX","Louisiana, Texas","B-0313-13","Class II","Red Blood Cells Leukocytes Reduced","W036512045868",".","1 unit","Blood products, collected from a donor who was at risk for variant Creutzfeldt-Jakob Disease (vCJD), were distributed.",9/4/2012,"09/04/2012",1/16/2013,"01/16/2013"
"Biologics",63417,"Terminated","LifeShare Blood Centers","Texarkana","TX","US","Voluntary: Firm Initiated","Letter","Louisiana","B-0373-13","Class II","Red Blood Cells Leukocytes Reduced","W036511025390",".","1 unit","Blood product, collected from a donor who emigrated from an area considered endemic for malaria, was distributed.",8/20/2012,"08/20/2012",1/23/2013,"01/23/2013"
"Food",63418,"Ongoing","Brookshire Grocery Company Manufacturing","Tyler","TX","US","Voluntary: Firm Initiated","Visit","TX, Louisiana and Southern Arkansas","F-1442-2013","Class I","Goldenbrook Farms Peanut Butter Bash Ice Cream, 1/2 gallon carton with UPC code 0009282530538","All Peanut Butter Bash Ice Cream distributed between May 2010 and September 2012 with UPC code 0009282530538.",".",,"The product has the potential to be contaminated with Salmonella. The peanut butter used in the manufacturing of the ice cream was supplied by Sunland, Inc.",10/8/2012,"10/08/2012",5/29/2013,"05/29/2013"
"Food",63420,"Ongoing","Talenti I, LLC","Dallas","TX","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Nationwide","F-1060-2013","Class I","Chocolate Peanut Butter Cup Gelato. The product was distributed to retail stores throughout the United States between September 2011 and September 2012 and is packaged in clear, plastic One Pint (473ml) containers with UPC code 1 86852 00094 5 printed on the back of the container and ''Best By'' date range of 3/21/13 through 3/26/14 printed on the bottom of the container. The firm also sold the product in a 5 QT size with UPC code 1-8685200090-7 and best by range 03/21/13 through 03/26/2014.","The product was distributed to retail stores throughout the United States between September 2011 and September 2012 and has UPC code 1 86852 00094 5 printed on the back of the container and ''Best By'' date range of 3/21/13 through 3/26/14 printed on the bottom of the container. The 5 QT size had UPC code 1-8685200090-7 and best by range 03/21/13 through 03/26/2014.",,"66,041 cases of pint size and 837 cases of 5 qt. size","Talenti Gelato is recalling Talenti Chocolate Peanut Butter Cup Gelato. The peanut butter used in this product has the potential to be contaminated with Salmonella. Consumption of food contaminated with Salmonella can cause serious and sometimes fatal infections in young children, frail or elderly people, and others with weakened immune systems. Healthy persons infected with Salmonella often experience fever, diarrhea (which may be bloody), nausea, vomiting and abdominal pain. In rare circumstances, infection with Salmonella can result in the organism getting into the bloodstream and producing more severe illnesses such as arterial infections (i.e., infected aneurysms), endocarditis and arthritis. This recall is being initiated because the peanut butter used in the product is supplied by Sunland, Inc., which has issued a national recall of some of its products. ",10/5/2012,"10/05/2012",3/20/2013,"03/20/2013"
"Food",63425,"Ongoing","Whole Foods Market Brand 365, Llc","Austin","TX","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","KY","F-0868-2013","Class I","Kentucky Bleu cheese was sold in the Louisville, KY, Whole Foods Market store, and was cut and packaged in clear plastic wrap. It was sold with a Whole Foods Market scale label reading 'Kenny's Farmhouse Cheese KY BL.","The Kenny's Farmhouse Cheese KY BL has a PLU of 209578 and includes all 'sell by' dates, which are noted on the scale label.",".","1.21 lbs","Whole Foods Market announces that it is recalling Kenny's Farmhouse Cheese KY BL sold in its Louisville, KYstore and Blue Kentucky Rose Kenny's cheese sold in its Nashville, TN store. These cheeses are being recalled because they have the potential to be contaminated with Listeria monocytogenes, an organism which can cause serious and sometimes fatal infections in young children, frail or elderly people, and others with weakened immune systems. Although healthy individuals may suffer only short-term symptoms such as high fever, severe headache, stiffness, nausea, abdominal pain and diarrhea, Listeria infection can cause miscarriages and stillbirths among pregnant women. To date, no illnesses have been reported. This recall is in response to a recall by Kenny's Farmhouse Cheese of Austin, Kentucky.",10/5/2012,"10/05/2012",1/16/2013,"01/16/2013"
"Food",63425,"Ongoing","Whole Foods Market Brand 365, Llc","Austin","TX","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","KY","F-0869-2013","Class I","The Blue Kentucky Rose cheese sold in the Nashville, TN, Whole Foods Market store was cut and packaged in clear plastic wrap.It was sold with a Whole Foods Market scale label reading 'Blue Kentucky Rose Kenny's.","The Blue Kentucky Rose Kenny's had a PLU of 71113 and includes all sell by dates, which are noted on the scale label.",".","0 lbs - it was found that the TN store never received the recalled lots","Whole Foods Market announces that it is recalling Kenny's Farmhouse Cheese KY BL sold in its Louisville, KYstore and Blue Kentucky Rose Kenny's cheese sold in its Nashville, TN store. These cheeses are being recalled because they have the potential to be contaminated with Listeria monocytogenes, an organism which can cause serious and sometimes fatal infections in young children, frail or elderly people, and others with weakened immune systems. Although healthy individuals may suffer only short-term symptoms such as high fever, severe headache, stiffness, nausea, abdominal pain and diarrhea, Listeria infection can cause miscarriages and stillbirths among pregnant women. To date, no illnesses have been reported. This recall is in response to a recall by Kenny's Farmhouse Cheese of Austin, Kentucky.",10/5/2012,"10/05/2012",1/16/2013,"01/16/2013"
"Drugs",63432,"Ongoing","Hospira Inc.","Lake Forest","IL","US","Voluntary: Firm Initiated","Press Release","Nationwide","D-263-2013","Class I","Lactated Ringer's and 5% Dextrose Injection, USP, 1000 mL flexible containers, Rx only, Hospira, Inc., Lake Forest, IL 60045, NDC 0409-7929-09.","Lot # :12-160-JT*, Exp 12/01/13",".","136,224 flexible containers","Non-Sterility: One confirmed customer report that product contained spore-like particulates, consistent with mold.",10/5/2012,"10/05/2012",4/24/2013,"04/24/2013"
"Devices",63433,"Ongoing","Bacterin International, Inc.","Belgrade","MT","US","Voluntary: Firm Initiated","Telephone","Nationwide Distribution in TX and GA.","Z-0800-2013","Class II","Bacterin International, Inc., Osteoselect Demineralized Bone Matrix DMB Putty; Graft ID# B090056-664 Donor# B090056 2.5cc Expiration Date: 12/25/2011; LBL 210-0010-1 REV: 040109; and Graft ID# B090056-675 Bone void filler for voids or gaps in bone. Indicated for treatment of surgically created osseous defects.","Graft ID# B090056-664 and Graft ID#: B090056-675, both with Donor# B090056 and Expiration Date: 12/25/2011",,"2 packages each containing 2.5cc of putty","Expired product was shipped to two customers.",4/18/2012,"04/18/2012",2/20/2013,"02/20/2013"
"Veterinary",63454,"Ongoing","Del Monte Corp","San Francisco","CA","US","Voluntary: Firm Initiated","Letter","Products were distributed nationwide.","V-120-2013","Class I","Nature's Recipe, Oven Baked Biscuits with Real Chicken, Made with sweet potatoes, oats, flaxseed., 19 ounces; UPC: 30521 51549","UPC: 30521 51549 Lot code: 2199TP; Best by: 10/11/13 Lot code: 2200TP; Best by: 10/12/13",".","4282 cases ( 6 unit/ case)","Product may be contaminated with Salmonella.",10/12/2012,"10/12/2012",1/23/2013,"01/23/2013"
"Food",63455,"Ongoing","Alymaq Inc","Laredo","TX","US","Voluntary: Firm Initiated","E-Mail","Ohio","F-1581-2013","Class III","ALYMAQ EXTRA FINE GRANULATED SUGAR AIB, www.alymaq.com, NET WT. 50 LBS. (22.68KG), KEEP IN A COOL AND DRY PLACE. Multi-wall polyethylene lined bag. 55 bags per pallet.","Lot EFG1007924 ",".","770 bags","Product has the potential to contain plastic fragments. ",10/1/2012,"10/01/2012",7/10/2013,"07/10/2013"
"Food",63456,"Ongoing","Hines Nut Co","Dallas","TX","US","Voluntary: Firm Initiated","Press Release","Nationwide and Puerto Rico","F-1194-2013","Class I","The HINES package is a cello/poly laminated bag, predominately blue, with a yellow label stating ''SALTED JUMBO VIRGINIA PEANUTS'' packed as 8 oz, 10 oz, 12 oz, 16 oz and 24 oz; Hines also packages three ''theme'' cello/poly laminated bags that are 5.5oz each. The themes for these bags are: 1) Independence Day - red, white and blue in color with a stylized flag on the front; 2) Football Season - with a football on the front; and Hunting Season - with a camouflage motif on the front of the bag. The Dollar General Clover Valley package is a cello/poly laminated bag, predominately white with red trim and red lettering. These bags are packaged as 8 oz bags.","The product will have best by/expiration dates on the packaging from October 12, 2012 through August 27, 2013. The lot number information can be located on the fourth line of the Packing Information: printed in black on the package. The packing information begins with the words ''BEST BUY''. The recall lot numbers are as follows, located on the fourth line of the ''BEST BUY'' statement: S03718, S03699, S03724, S03753, S03765, S03784, S03798, S03806, S03810, S03824, S03826, S03840, S03863, S03886, S03907, S03928, S03933, S03938, S03950, S03958, S03967, S03972, S03978, S03989, S03991, S04012, S04025, S04042, S04054, S04066, S04097, S04109, S04123, S04134, S04141, S04141, S04165, S04200, S04201, S04211, S04229, S04236, and S04247.",,"Approximately 57,000 lbs","Hines Nut Company Inc. recalled its SALTED JUMBO VIRGINIA IN-SHELL PEANUTS. These peanuts were processed in the Sunland, Inc. Peanut Processing Plant and may be contaminated with Salmonella. Salmonella is an organism that can cause serious and sometimes fatal infections in young children, frail or elderly people, and those with weakened immune systems. Healthy persons infected with Salmonella often experience fever, diarrhea (which may be bloody), nausea, vomiting and abdominal pain. In rare circumstances, infection with Salmonella can result in the organism getting into the bloodstream and producing more severe illnesses such as arterial infections (i.e., infected aneurysms), endocarditis and arthritis.",10/15/2012,"10/15/2012",3/20/2013,"03/20/2013"
"Devices",63457,"Ongoing","Stryker Howmedica Osteonics Corp.","Mahwah","NJ","US","Voluntary: Firm Initiated","Letter","Worldwide distribution: USA (nationwide) including states of: AL, CO, CT, IL, IN, MO, MS, NC, NJ, NY, OR,and TX; and countries of: Australia, Canada, France, Spain and United Kingdom.","Z-0610-2013","Class II","Stryker Howmedica Osteonics; Stryker T2 Humerus System Teflon Tube, sterile; REF 1806-0073S The T2 Nailing System is designed to treat complex fractures in Humeral, Femoral, Tibial and Ankle applications. The Teflon Tube is an optional instrument used to exchange the Ball Tip Guide Wire with the Smooth Tip Guide Wire once reaming is completed. Stryker Stryker Trauma GmbH 24232 Schonkirchen, Germany distributed in USA by: Howmedica Osteonics Corp., 235 Corporate Drive, ","Catalog No: 1806-0073S Lot Code:123596 ",".","100 units (73 units US; 27 units OUS)","During the manufacturing of the affected lot a manufacturing error has led to embrittlement of the tube material of the T2 Humerus Teflon Tube. ",8/6/2012,"08/06/2012",1/2/2013,"01/02/2013"
"Veterinary",63459,"Ongoing","TBD Brands","Exeter","NH","US","Voluntary: Firm Initiated","E-Mail","Nationwide","V-134-2013","Class I","Yoghund Organic Banana & Peanut Butter, Organic Frozen Yogurt for Dogs, 4-3.5 fl. oz. cups (4 pack), 14 fl. oz., (416 ml).","Case: Lot Code: 26812 or earlier Cups: Best By Dates of 9.24.14 or earlier",," 5211 Cases (24 case -3.5 fl.oz cups/4 pack)","Frozen dog treats recalled due to possible contamination with salmonella due to Sunland Peanut Butter recall",10/10/2012,"10/10/2012",2/13/2013,"02/13/2013"
"Biologics",63461,"Terminated","Blood Systems Inc/dba United Blood Services","Meridian","MS","US","Voluntary: Firm Initiated","Telephone","Mississippi; Switzerland","B-0285-13","Class II","Blood and Blood Products for Reprocessing","W0416120040230; ",".","1","Blood products, collected from a donor who was at risk for variant Creutzfeldt-Jakob disease (vCJD), were distributed.",10/3/2012,"10/03/2012",1/9/2013,"01/09/2013"
"Biologics",63461,"Terminated","Blood Systems Inc/dba United Blood Services","Meridian","MS","US","Voluntary: Firm Initiated","Telephone","Mississippi; Switzerland","B-0286-13","Class II","Red Blood Cells Leukocytes Reduced","W0416120040230; ",".","1","Blood products, collected from a donor who was at risk for variant Creutzfeldt-Jakob disease (vCJD), were distributed.",10/3/2012,"10/03/2012",1/9/2013,"01/09/2013"
"Biologics",63462,"Terminated","LifeServe Blood Center","Des Moines","IA","US","Voluntary: Firm Initiated","Telephone","Iowa","B-0287-13","Class II","Red Blood Cells Leukocytes Reduced","W037911147282; ",".","1","Blood product, which was not quarantined subsequent to receiving information regarding a post donation illness, was distributed.",8/5/2011,"08/05/2011",1/9/2013,"01/09/2013"
"Biologics",63463,"Terminated","Blood Bank Of Delmarva, Inc","Newark","DE","US","Voluntary: Firm Initiated","Telephone","Delaware","B-0288-13","Class II","Red Blood Cells Leukocytes Reduced Irradiated","W036912222319; ",".","1","Blood product, labeled with an incorrect expiration date, was distributed.",8/28/2012,"08/28/2012",1/9/2013,"01/09/2013"
"Biologics",63464,"Terminated","American National Red Cross The","Pomona","CA","US","Voluntary: Firm Initiated","Other","California","B-0289-13","Class III","Blood and Blood Products for Reprocessing","06LZ34745; ",".","1","Blood product, which was collected from a donor in which donor suitability was not adequately determined, was distributed.",8/25/2012,"08/25/2012",1/9/2013,"01/09/2013"
"Veterinary",63468,"Completed","Sunland, Incorporated","Portales","NM","US","Voluntary: Firm Initiated","Press Release","National distribution under various brand names including all 50 U.S. States with some international distribution Hong Kong.","V-162-2013","Class I","Dogsbutter RUC with Flax PB, 16 oz UPC 3050.","Best-If-Used-By Dates between March 1, 2011 and September 24, 2013.",,"934 x 16 oz ","Sunland, Inc. is conducting a voluntary limited recall of its Almond, Peanut, and Cashew Butter products and Tahini and Roasted Blanched Peanut Products, manufactured between May 1, 2010 and September 24, 2012, because these products may be contaminated with Salmonella.",9/24/2012,"09/24/2012",5/22/2013,"05/22/2013"
"Veterinary",63468,"Completed","Sunland, Incorporated","Portales","NM","US","Voluntary: Firm Initiated","Press Release","National distribution under various brand names including all 50 U.S. States with some international distribution Hong Kong.","V-164-2013","Class I","Sunland Raw Shelled Wildlife (not for human use), 50 lb item 402.","Identified with Best By Dates March 1, 2011 through September 24, 2013.",,"233,450 lbs","Sunland, Inc. is conducting a voluntary limited recall of its Almond, Peanut, and Cashew Butter products and Tahini and Roasted Blanched Peanut Products, manufactured between May 1, 2010 and September 24, 2012, because these products may be contaminated with Salmonella.",9/24/2012,"09/24/2012",5/22/2013,"05/22/2013"
"Veterinary",63468,"Completed","Sunland, Incorporated","Portales","NM","US","Voluntary: Firm Initiated","Press Release","National distribution under various brand names including all 50 U.S. States with some international distribution Hong Kong.","V-163-2013","Class I","Sunland Valencia Roasted and Blanched Wildlife, 30 lb UPC 41322.","Best-If-Used-By Dates between March 1, 2011 and September 24, 2013.",,"184 x 30 lb","Sunland, Inc. is conducting a voluntary limited recall of its Almond, Peanut, and Cashew Butter products and Tahini and Roasted Blanched Peanut Products, manufactured between May 1, 2010 and September 24, 2012, because these products may be contaminated with Salmonella.",9/24/2012,"09/24/2012",5/22/2013,"05/22/2013"
"Biologics",63474,"Terminated","Blood Centers of the Pacific - Irwin Center","San Francisco","CA","US","Voluntary: Firm Initiated","Telephone","California","B-0291-13","Class II","Platelets Pheresis Leukocytes Reduced","W117012326743U; W117012326743U; W117012326743U; W117011507369G; W117011507369G; W1170114535114; ",".","6","Blood products, which were labeled as leukoreduced, but were not tested to verify the White Blood Cell counts, were distributed.",10/5/2012,"10/05/2012",1/9/2013,"01/09/2013"
"Biologics",63474,"Terminated","Blood Centers of the Pacific - Irwin Center","San Francisco","CA","US","Voluntary: Firm Initiated","Telephone","California","B-0290-13","Class II","Platelets Pheresis Leukocytes Reduced Irradiated","W117012518302Q; W117012518302Q; ",".","2","Blood products, which were labeled as leukoreduced, but were not tested to verify the White Blood Cell counts, were distributed.",10/5/2012,"10/05/2012",1/9/2013,"01/09/2013"
"Biologics",63476,"Terminated","Community Blood Center Of Gtr KC","Kansas City","MO","US","Voluntary: Firm Initiated","FAX","Missouri","B-0292-13","Class II","Red Blood Cells Leukocytes Reduced","W045012008969; ",".","1","Blood product, which was collected from a donor who traveled to a malarial endemic area, was distributed. ",9/17/2012,"09/17/2012",1/9/2013,"01/09/2013"
"Devices",63485,"Ongoing","MOOG Medical Devices Group","Salt Lake City","UT","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution and US Nationwide in the countries of (Germany, Sweeden, Croatia, Lithuania, and Dubai).","Z-0764-2013","Class II","Infinity Enteralite Ambulatory Feeding Pumps, List number: INFKIT2 - Addendum to Operator's Manual Product usage: provide a means for the volumetric delivery of fluids used in Enteral applications.","003, 509350004, 509350005, 509350006, 509350007, 509350008, 509350009, 509350010, 509350011, 509350012, 509350013, 509350014, 509350015, 509350016, 509350017, 509350018, 509350019, 509350020, 509350021, 509350022, 509350023, 509350024, 509350025, 509350026, 509350027, 509350028, 509350029, 509350030, 509350031, 509350032, 509350033, 509350034, 509350035, 509350036, 509350037, 509350038, 509350039, 509350040, 509350041, 509350042, 509350043, 509350044, 509350045, 509350046, 509350047, 509350048, 509350049, 509350050, 509350051, 509350052, 509350053, 509350054, 509350055, 509350056, 509350057, 509350058, 509350059, 509350060, 509350061, 509350062, 509350063, 509350064, 509350065, 509350066, 509350067, 509350068, 509350069, 509350070, 509350071, 509350072, 509350073, 509350074, 509350075, 509350076, 509350077, 509350078, 509350079, 509350080, 509350081, 509350082, 509350083, 509350084, 509350085, 509350086, 509350087, 509350088, 509350089, 509350090, 509350091, 509350092, 509350093, 509350094, 509350095, 509350096, 509350097, 509350098, 509350099, 509350100, 509350101, 509350102, 509350103, 509350104, 509350105, 509345014, 509345015, 509345016, 509345017, 509345018, 509345019, 509345020, 509345021, 509345005, 509345006, 509345007, 509345008, 509345009, 509351011, 509351012, 509351013, 509351014, 509351015, 509351016, 509351017, 509351018, 509351019, 509351020, 509351021, 509351022, 509351023, 509351024, 509351025, 509351026, 509351027, 509351028, 509351029, 509351030, 509351031, 509351032, 509351033, 509351034, 509351035, 509351038, 509351037, 509351003, 509351004, 509351005, 509351006, 509351007, 509351008, 509351009, 509351010, 509351036, 509351039, 509351040, 509351041, 509351042, 509351043, 509351049, 509351050, 509351051, 509351052, 509351053, 509351054, 509351055, 509351056, 509351057, 509351058, 509351059, 509351060, 509351061, 509351062, 509351063, 509351064, 509351065, 509351066, 509351067, 509351068, 509351069, 509351070, 509351071, 509351072, 509351073, 509351048, 509351047, 509351046, 509351045, 50935",".","92,488 units","The firm is adding an addendum to the operator's manual for Infinity Enteralite Ambulatory Feeding Pumps pertaining to the Infinite Dose mode and the inability of the Pump to detect air in line.",10/12/2012,"10/12/2012",2/6/2013,"02/06/2013"
"Devices",63494,"Ongoing","Siemens Healthcare Diagnostics, Inc.","Tarrytown","NY","US","Voluntary: Firm Initiated","Letter","Nationwide distribution: USA including Puerto Rico and the states of AL, OH, MO, GA, IL, CT, IA, SC, VA, TX, FL, NY, NC, CA, NM, AZ, CA, MI, NJ, PR, MS, NE, WV, PA, MT, MA, MD, KS, NH, TN, VT, LA, CO, ID, WA, NH, DE and OR.","Z-0988-2013","Class III","Siemens Dimension Vista(R) Alkaline Phosphatase (ALP) Calibrator The ALP CAL is an in vitro diagnostic product for the calibration of the Alkaline Phosphatase method on the Dimension Vista'' System.","Lot 2AD052 Catolog KC330",,"1985 cartons","Correlation slope bias and accuracy shift",10/10/2012,"10/10/2012",4/3/2013,"04/03/2013"
"Devices",63497,"Ongoing","Brookstone Company, Inc.","Merrimack","NH","US","Voluntary: Firm Initiated","Letter","Nationwide Distribution.","Z-0616-2013","Class II","Brookstone Heated Body Bean, electrically heated SKU numbers: 734863 (BlNationwide Distributionue), 734864 (Plum), 734865 (Red). Brookstone 3 in 1 wrap ,SKU734397 (Brown). The Products are liquid filled bean shaped pouches that are electrically heated and then detached from the charger prior to use.","All lot codes",".","109,956 units","Additional Warning Statement to prevent burns to the skin ",11/2/2012,"11/02/2012",1/2/2013,"01/02/2013"
"Biologics",63507,"Terminated","Community Blood Centers of Florida, Inc.","Lauderhill","FL","US","Voluntary: Firm Initiated","Telephone","Illinois; Florida","B-0294-13","Class II","Platelets Pooled Leukocytes Reduced","W036810814828; W036811813763; ",".","2","Blood products, collected from a donor in whom donor suitability was not adequately determined, were distributed.",5/22/2012,"05/22/2012",1/9/2013,"01/09/2013"
"Biologics",63507,"Terminated","Community Blood Centers of Florida, Inc.","Lauderhill","FL","US","Voluntary: Firm Initiated","Telephone","Illinois; Florida","B-0295-13","Class II","Red Blood Cells Leukocytes Reduced","W036811169821; ",".","1","Blood products, collected from a donor in whom donor suitability was not adequately determined, were distributed.",5/22/2012,"05/22/2012",1/9/2013,"01/09/2013"
"Biologics",63507,"Terminated","Community Blood Centers of Florida, Inc.","Lauderhill","FL","US","Voluntary: Firm Initiated","Telephone","Illinois; Florida","B-0296-13","Class II","Fresh Frozen Plasma","W036810255653; W036811169821; W036810190296; ",".","3","Blood products, collected from a donor in whom donor suitability was not adequately determined, were distributed.",5/22/2012,"05/22/2012",1/9/2013,"01/09/2013"
"Biologics",63507,"Terminated","Community Blood Centers of Florida, Inc.","Lauderhill","FL","US","Voluntary: Firm Initiated","Telephone","Illinois; Florida","B-0293-13","Class II","Red Blood Cells","W036810255653; W036810190296; ",".","2","Blood products, collected from a donor in whom donor suitability was not adequately determined, were distributed.",5/22/2012,"05/22/2012",1/9/2013,"01/09/2013"
"Drugs",63510,"Ongoing","Estee Lauder Inc","New York","NY","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Nationwide, Puerto Rico, Bermuda and Panama","D-151-2013","Class III","ESTEE LAUDER DayWear Sheer Tint Release, Advanced Multi-Protection Anti-Oxidant Moisturizer Broad Spectrum SPF15, All Skin types, 1.7 FL. OZ. LIQ/50 ml (tube inside a unit carton) with UPC No. 2713179904, Code WKEM-01, and 1.5 mL foil sample packets, ESTEE LAUDER, DIST., NEW YORK, N.Y. 10022 NDC 11559-008-01 "," A70, A80, AA0, B11, A31, A51, B51, A81, A91, A12, A22, A72, BA0, AB0, BB0, CB0, AC0, BC0, A11, A21, B21, B31, A41.",,"1.7 oz. 241,236 tubes; 1.5 mL sample size 544,548 foil packs ","Failed Stability Specifications: The active sunscreen ingredient, avobenzone 3%, may not be stable over the shelf life, the sunscreen effectiveness may be less than labeled.",10/23/2012,"10/23/2012",2/13/2013,"02/13/2013"
"Veterinary",63513,"Ongoing","Wildwood Seeds","Monroe","OR","US","Voluntary: Firm Initiated","Telephone","Products are distributed in Oregon and Washington","V-124-2013","Class I","Fortified feeds are sold under Sleek and Sassy brand. Different products with UPCs are listed below. Fortified Large Hookbill with the UPCs: 0-1253111402-6; 0-1253111404-0; 0-1253111420-0; 0-1253111440-8; Fortified Large Hookbill No Sunflower with the UPCs: 0-1253111502-3; 0-1253111504-7; 0-1253111520-7; 0-1253111540-5; Fortified Parrot with the UPCs: 0-1253113003-3; 0-1253113025-5; Fortifed Small Animal with the UPCs: 0-1253112902-0; 0-1253112904-4; 0-1253112920-4; 0-1253112940-2;","No expiration dates on packages. Product has lot code 01148 through 01241 (it is interpreted as: 11 is for manufacturing year 2011, and 48 is week 48 of 2011).",".","approximately 1560 lbs.","Pet bird food and small animal pet foods are recalled due to a potential to be contaminated with Salmonella.",10/12/2012,"10/12/2012",1/23/2013,"01/23/2013"
"Veterinary",63513,"Ongoing","Wildwood Seeds","Monroe","OR","US","Voluntary: Firm Initiated","Telephone","Products are distributed in Oregon and Washington","V-123-2013","Class I","Garden Guinea Pig/Rabbit diet is sold under Sleek and Sassy brand. Product is packaged from 2 lb., 4 lb., 20 lb., to 40 lb in polysynth bag. Garden Guinea Pig/Rabbit has UPC is 0-1253113502-1.","No expiration dates on packages. Product has lot code 01148 through 01241 (it is interpreted as: 11 is for manufacturing year 2011, and 48 is week 48 of 2011).",".","approximately 984 lbs.","Pet bird food and small animal pet foods are recalled due to a potential to be contaminated with Salmonella.",10/12/2012,"10/12/2012",1/23/2013,"01/23/2013"
"Veterinary",63513,"Ongoing","Wildwood Seeds","Monroe","OR","US","Voluntary: Firm Initiated","Telephone","Products are distributed in Oregon and Washington","V-121-2013","Class I","Pet Bird Feed- Sleek and Sassy are sold under multiple names. Products with UPCs are listed below. Garden Conure has the following UPCs: 0-1253111602-0; 0-1253111604-4; 0-1253111620-4; 0-1253111640-2; Garden Large Hookbill has the following UPCs: 0-1253113102-3; 0-1253113104-7; 0-1253113120-7; 0-1253113140-5; Garden Large Hookbill No Sunflower has the following UPCs: 0-1253113202-0; 0-1253113204-4; 0-1253113220-4; 0-1253113240-2; Garden Parrot has the UPCs: 0-1253112103-1; 0-1253112125-3; Nutty Garden Grain has the UPCS: 0-1253115502-9; 0-1253115504-3; 0-1253115520-3; 0-1253115540-1; Garden Macaw has the UPCs: 0-1253115602-6; 0-1253115604-0; 0-1253115620-0; 0-1253115640-8; Garden Complete Pellet has the UPCs: 0-1253115702-3; 0-1253115704-7; 0-1253115720-7; 0-1253115740-5; Fruit Veggie Nut Treat has the UPCs: 0-1253114302-6; 0-1253114304-0; 0-1253114320-0; 0-1253114316-3; 0-1253114332-3;","No expiration dates on packages. Product has lot code 01148 through 01241 (it is interpreted as: 11 is for manufacturing year 2011, and 48 is week 48 of 2011).",".","approximately 4904 lbs.","Pet bird food and small animal pet foods are recalled due to a potential to be contaminated with Salmonella.",10/12/2012,"10/12/2012",1/23/2013,"01/23/2013"
"Veterinary",63513,"Ongoing","Wildwood Seeds","Monroe","OR","US","Voluntary: Firm Initiated","Telephone","Products are distributed in Oregon and Washington","V-122-2013","Class I","Small Pet Animal Food is sold under Sleek and Sassy brand. Product are packaged from 2 lb., 4 lb., 20 lb., to 40 lb in polysynth bag. Garden Small Animal has the following UPCs: 0-1253113902-9; 0-1253113904-3; 0-1253113920-3; 0-1253113940-1;","No expiration dates on packages. Product has lot code 01148 through 01241 (it is interpreted as: 11 is for manufacturing year 2011, and 48 is week 48 of 2011).",".","approximately 566 lbs.","Pet bird food and small animal pet foods are recalled due to a potential to be contaminated with Salmonella.",10/12/2012,"10/12/2012",1/23/2013,"01/23/2013"
"Biologics",63514,"Terminated","Southern California Permanente Medical Group Blood Donor Ctr","Downey","CA","US","Voluntary: Firm Initiated","FAX","California","B-0297-13","Class II","Red Blood Cells (Apheresis) Leukocytes Reduced","W071812000498; ",".","1","Blood products, which were collected from a donor who lived in a malarial endemic area, were distributed.",7/22/2012,"07/22/2012",1/9/2013,"01/09/2013"
"Biologics",63514,"Terminated","Southern California Permanente Medical Group Blood Donor Ctr","Downey","CA","US","Voluntary: Firm Initiated","FAX","California","B-0298-13","Class II","Fresh Frozen Plasma","W071812000498; ",".","1","Blood products, which were collected from a donor who lived in a malarial endemic area, were distributed.",7/22/2012,"07/22/2012",1/9/2013,"01/09/2013"
"Biologics",63515,"Terminated","Sanford Medical Center (blood Bank)","Sioux Falls","SD","US","Voluntary: Firm Initiated","FAX","Pennsylvania","B-0248-13","Class II","Red Blood Cells","W089212004412; ",".","1","Blood product, collected from a donor who emigrated from an area considered endemic for malaria, was distributed.",9/26/2012,"09/26/2012",1/9/2013,"01/09/2013"
"Drugs",63522,"Ongoing","Hospira Inc.","Lake Forest","IL","US","Voluntary: Firm Initiated","Letter","Nationwide","D-184-2013","Class II","HEXTEND 6% Hetastarch in Lactated Electrolyte Injection, 500 mL, Rx only , MANUFACTURED AND DISTRIBUTED BY HOSPIRA, INC., LAKE FOREST, IL 60045, NDC 0409-1555-54 ","Lot # 10-199-JT Exp. 10/13",,"11,412 bags","Lack of Assurance of Sterility: There is the potential for the solution to leak from the seal of the fill tube to the bag.",10/22/2012,"10/22/2012",3/13/2013,"03/13/2013"
"Drugs",63525,"Ongoing","Zi Xiu Tang Success, LLC","Kutztown","PA","US","Voluntary: Firm Initiated","Letter","Nationwide and Canada to distributors and consumers.","D-370-2014","Class I","Ultimate Formula, Net Wt. 250 mg, 48 capsules per bottle, Distributed by: Zi Xiu Tang Success, LLC., Trexlertown, PA 18087, UPC 7 9357304140 1","Lot numbers: 05/25/2012, Exp 05/24/14; 07/29/2012, Exp 07/28/14; and 08/05/2012, Exp 08/04/14",".","16126 bottles","Marketed Without An Approved NDA/ANDA: Products were found to contain undeclared sibutramine, the active ingredient in a previously approved FDA product indicated for weight loss but removed from the market for safety reasons, making these products unapproved new drugs.",10/22/2012,"10/22/2012",12/26/2013,"12/26/2013"
"Drugs",63525,"Ongoing","Zi Xiu Tang Success, LLC","Kutztown","PA","US","Voluntary: Firm Initiated","Letter","Nationwide and Canada to distributors and consumers.","D-369-2014","Class I","Classic Zi Xiu Tang, Bee Pollen Capsule, Net Wt. 250 mg x 60 capsules per bottle, Distributed by: Zi Xiu Tang Success, LLC., Trexlertown, PA 18087, UPC 6 937000 700019","Lot numbers: 04/15/2012, Exp 04/15/14; 05/15/2012, Exp 05/15/14; 06/15/2012, Exp 06/15/14; and 07/15/2012, Exp 07/15/14",".","6084 bottles","Marketed Without An Approved NDA/ANDA: Products were found to contain undeclared sibutramine, the active ingredient in a previously approved FDA product indicated for weight loss but removed from the market for safety reasons, making these products unapproved new drugs.",10/22/2012,"10/22/2012",12/26/2013,"12/26/2013"
"Biologics",63526,"Terminated","Talecris Plasma Resources","Minneapolis","MN","US","Voluntary: Firm Initiated","FAX","North Carolina","B-0299-13","Class II","Source Plasma","5090183875; 5090182331; ",".","2","Blood products, collected from a donor, whose suitability to donate was not adequately determined, were distributed.",10/5/2012,"10/05/2012",1/9/2013,"01/09/2013"
"Biologics",63527,"Terminated","Lane Memorial Blood Bank","Eugene","OR","US","Voluntary: Firm Initiated","FAX","California","B-0377-13","Class II","Red Blood Cells Leukocytes Reduced","W137512105781; ",".","1 unit","Blood product, which was collected from a donor who traveled to malarial endemic areas, was distributed. ",9/21/2012,"09/21/2012",1/30/2013,"01/30/2013"
"Food",63529,"Completed","The Dannon Company, Inc - Discovery & Innovation Center","White Plains","NY","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","The product was distributed nationwide including the states of: FL, GA, IL, IN, KY, MD, ME, MI, NC, NY, OH, PA, SC, VA, WI.","F-1241-2013","Class II","Dannon Activia LIGHT Nonfat Yogurt Strawberry / Blueberry Flavor 12-4oz cups STRAWBERRY INGREDIENTS: CULTURED GRADE A NON FAT MILK, STRAWBERRIES***BLUEBERRY INGREDIENTS: CULTURED GRADE A NON FAT MILK, BLUEBERRY PUREE***DISTRIBUTED BY THE DANNON COMPANY, WHITE PLAINS, NY 10603***UPC 36632 03581 Expiration code of DEC 05 2012 MZ","UPC 36632 03581 Expiration code of DEC 05 2012 MZ",".","4,494 cases / 12 / 4 oz","The recalled products may potentially contain metal fragment(s) from a faulty manufacturing part.",10/23/2012,"10/23/2012",3/27/2013,"03/27/2013"
"Food",63529,"Completed","The Dannon Company, Inc - Discovery & Innovation Center","White Plains","NY","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","The product was distributed nationwide including the states of: FL, GA, IL, IN, KY, MD, ME, MI, NC, NY, OH, PA, SC, VA, WI.","F-1242-2013","Class II","Dannon Light & Fit Carb & Sugar Control Cultured Dairy Snack Vanilla Flavor 4x4oz cups","UPC 36632 00427 Expiration code of NOV 25 2012 MZ",".","662 cases / 6 / 4x4 oz cups ","The recalled products may potentially contain metal fragment(s) from a faulty manufacturing part.",10/23/2012,"10/23/2012",3/27/2013,"03/27/2013"
"Food",63529,"Completed","The Dannon Company, Inc - Discovery & Innovation Center","White Plains","NY","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","The product was distributed nationwide including the states of: FL, GA, IL, IN, KY, MD, ME, MI, NC, NY, OH, PA, SC, VA, WI.","F-1240-2013","Class II","Dannon Activia LIGHT Nonfat Yogurt Peach Flavor 4x4oz cups INGREDIENTS: CULTURED GRADE A NONFAT MILK, WATER, PEACHES ***DISTRIBUTED BY: THE DANNON COMPANY, INC. WHITE PLAINS, NY 10603 UPC 36632 02633 Expiration code of DEC 04 2012 MZ ","UPC 36632 02633 Expiration code of DEC 04 2012 MZ ",".","2,430 cases / 6 / 4x4oz cups","The recalled products may potentially contain metal fragment(s) from a faulty manufacturing part.",10/23/2012,"10/23/2012",3/27/2013,"03/27/2013"
"Devices",63531,"Ongoing","Zimmer, Inc.","Warsaw","IN","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution-USA (nationwide) and the countries of Denmark, Germany, Greece, Hungary, Ireland, Italy, Netherlands, Spain, Sweden, UK, Poland, France, Australia, Chile, Canada, India, Japan, New Zealand, Peru, South Africa, Colombia, Ukraine, and UAE.","Z-0774-2013","Class II","Trilogy Acetabular AB Shells with Cluster Holes. The Trilogy Acetabular System is indicated for either cemented or uncemented use in individuals undergoing surgery for rehabilitating hip damage.","Lot 61824006 61804625 61863921 61940938 61770118 61770119 61847292 62036280 62041700 62041701 62074562 61676075 61686843 61878991 62086541 07891486 61771223 61236214 61684940 61576456 61771214 61514324 62049465 61398128 61543099 61720987 61738788 61838669 61851627 61531431 61532988 61559753 61610337 61633328 61639533 61667050 61680958 61714507 61737663 61761440 61765336 61765339 61771213 61771215 61800650 61807684 61810992 61821391 61831558 61844005 61946147 61980002 61992760 62005870 62011425 62016937 62073253 62084392 61676078 61962791 62036281 61338624 61581713 61817237 61581712 61581714 61656292 61757712 61765340 61821393 61236215 61236216 61338666 61398129 61514325 61514326 61532990 61581711 61727955 61738789 61771216 61771221 61784813 61796131 61831565 61838671 61844006 61851628 61946319 61992761 61810993 61930116 62036282 61610338 61639534 61962792 61998856 62011426 61684942 61667051 62078581 61676591 61476225 61639535 62049467 61543101 61771224 61553782 61734089 62052856 61980006 61236218 61236219 61765337 61831549 62078789 61236217 61531433 61581715 61629973 61656293 61727956 61752676 61771217 61771218 61780740 61791906 61807685 61817238 61831566 61838672 61844007 61860174 62011427 62023771 62073255 61998857 61667052 61676081 61962793 61676592 61338667 61476226 61236220 61236223 61757711 61791907 61709237 61771219 61236224 61236222 61236225 61499616 61532989 61566825 61576457 61639536 61670754 61720991 61742089 61765341 61796132 61801296 61851630 61980010 61236221 61375787 61531434 61531435 61549723 61553783 61629974 61633329 61656294 61714520 61761441 61771220 61771225 61817239 61821392 61831602 61844008 61860172 62023772 61734088 61381468 61771222 61807695 62078790 61271672 61962794 61450095 61935498 62011428 61648309 61831560 61992762 61676593 61684943 61589940 61398130 62073158 62049468 62078791 6",,"275,952 units","Some units of Trilogy shells manufactured since March 2009 may be below the lower range of the pore size specification (as low as 28% vs. 30% porosity specification). On 10/31/2012, the firm expanded the recall action to include lots of Uni-Hole Trilogy Acetabular System shells.",9/14/2012,"09/14/2012",2/13/2013,"02/13/2013"
"Devices",63531,"Ongoing","Zimmer, Inc.","Warsaw","IN","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution-USA (nationwide) and the countries of Denmark, Germany, Greece, Hungary, Ireland, Italy, Netherlands, Spain, Sweden, UK, Poland, France, Australia, Chile, Canada, India, Japan, New Zealand, Peru, South Africa, Colombia, Ukraine, and UAE.","Z-0770-2013","Class II","Trilogy F/M Acetabular Shell without holes SOLID HA. Several ODs: 38MM, 40MM, 42MM, 44MM, 46MM, 48MM, 50MM, 52MM, 54MM, 56MM, 58MM, 60MM, 62MM, 64MM, 66MM, 68MM, 70MM. The Trilogy Acetabular System is indicated for either cemented or uncemented use in individuals undergoing surgery for rehabilitating hip damage.","62245445 61633287 61709296 61633288 62252762 61843993 61992773 61761520 62215528 61398137 61338646 00115088 00115232 61403276 62167207 61371922 61807719 62005855 61330613 61490851 61514339 61761502 07892017 61268979 61278050 61278051 61338633 61354843 61384943 61622997 61693498 61730092 61780750 61831580 61581946 62109740 61227827 61645213 61461911 00113594 62252763 62016972 61930133 61236171 61499618 61693502 61926650 61962831 62049520 07892026 61268980 61330614 61371923 61398138 61449976 61490852 61581982 61603351 61629975 61639547 61748057 61772411 61801293 61831567 61851623 61366107 61278052 61278053 62084417 62185026 61227829 61338634 61658815 61476210 62245453 62056760 62030497 61761515 61236172 61366108 61403277 61566835 61596084 61813378 61860182 62011471 07892036 61203322 61268981 61278054 61278055 61281003 61338683 61360704 61371924 61419062 61449979 61490853 61581947 61622960 61633331 61737670 61784845 61831571 61962836 62180913 62078807 61227830 61645214 61476211 11000607 62011479 62042217 07891705 61603352 61278056 61338684 61366109 61769843 61831589 61973149 61236173 61268982 61278057 61278058 61333096 61371925 61514340 61633289 61791914 61813390 61860184 61946161 62084419 62245455 61429360 61645215 61227831 61384944 62270121 11000606 62049525 62005854 62159369 61680959 61851619 61596085 61792009 61236117 61268983 61278059 61278060 61338685 61366110 61371926 61639548 61819016 61398139 62011494 61670759 61950846 61603353 61278061 61419063 61490854 61761519 62126091 61843995 61622961 ",,"275,952 units","Some units of Trilogy shells manufactured since March 2009 may be below the lower range of the pore size specification (as low as 28% vs. 30% porosity specification). On 10/31/2012, the firm expanded the recall action to include lots of Uni-Hole Trilogy Acetabular System shells.",9/14/2012,"09/14/2012",2/13/2013,"02/13/2013"
"Devices",63531,"Ongoing","Zimmer, Inc.","Warsaw","IN","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution-USA (nationwide) and the countries of Denmark, Germany, Greece, Hungary, Ireland, Italy, Netherlands, Spain, Sweden, UK, Poland, France, Australia, Chile, Canada, India, Japan, New Zealand, Peru, South Africa, Colombia, Ukraine, and UAE.","Z-0769-2013","Class II","Trilogy F/M Acetabular Shell without holes. Several ODs: 40MM, 42MM, 44MM, 46MM, 48MM, 50MM, 52MM, 54MM, 56MM, 58MM, 60MM, 62MM, 64MM, 66MM, 68MM, 70MM. The Trilogy Acetabular System is indicated for either cemented or uncemented use in individuals undergoing surgery for rehabilitating hip damage.","61216907 61157229 00369603 61452214 00370029 00369698 61176450 00369643 00370031 61454835 00369732 00369699 61216908 61673516 61642322 62065259 61906448 61263152 61454836 61476896 00369630 61775736 61943339 61403525 61642325 61732773 61263539 61642324 61906449 62022702 62076908 61885843 61309789 61928501 61237709 61292681 61407876 61825843 61452216 61817457 61237707 61237708 61271325 61327754 61452215 61452217 61489313 61519975 61536413 61564182 61598285 61642323 00370315 00369632 61744558 61885845 62079957 61732772 61928502 61783457 61825844 61869694 61906453 62010604 61846487 61993146 61642326 61779030 61783460 61906450 62052790 61536692 61487482 61487481 61598295 61632192 61309790 61511677 61455839 61263540 61367254 61321073 61237710 61281183 61455840 00369649 61976102 61788120 61885847 61928503 61801103 61840614 61947562 61996712 61813950 61899040 61911390 62001304 61864069 61536693 61473713 61417315 62076907 61487483 61489314 61281184 61237711 61237712 61642328 61260584 61306613 61329094 61403527 61455843 61598296 61642327 00369605 61642329 61813945 61980779 61947563 62076909 61928504 61955589 61292682 62006523 61801104 61813948 61864070 61885848 61906451 61476897 61612715 61642330 61470887 61417316 61473724 61567576 61256570 61455841 61215903 61237713 61281185 61309791 61397913 61536694 00369645 61728663 61775735 61801102 61864071 61996713 61292684 61642332 61891249 61526509 61611815 61976103 61760310 61768196 61951207 62043439 61235829 61237714 61271326 61429593 61500680 61526508 61611819 61817458 62079956 61260587 61452212 61321074 61403528 61417317 61469130 61500681 61801101 61825845 61911391 62065258 61350519 00369738 00369635 61548179 61928505 61532294 61548180 61642333 61803766 61983681 62036846 61237716 61309792 61403529 61412049 61889258 61256571 61424318 61455846 61476898 62006522 00369803 619216",,"275,952 units","Some units of Trilogy shells manufactured since March 2009 may be below the lower range of the pore size specification (as low as 28% vs. 30% porosity specification). On 10/31/2012, the firm expanded the recall action to include lots of Uni-Hole Trilogy Acetabular System shells.",9/14/2012,"09/14/2012",2/13/2013,"02/13/2013"
"Devices",63531,"Ongoing","Zimmer, Inc.","Warsaw","IN","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution-USA (nationwide) and the countries of Denmark, Germany, Greece, Hungary, Ireland, Italy, Netherlands, Spain, Sweden, UK, Poland, France, Australia, Chile, Canada, India, Japan, New Zealand, Peru, South Africa, Colombia, Ukraine, and UAE.","Z-0776-2013","Class II","Trilogy Acetabular AB Shells with Holes. The Trilogy Acetabular System is indicated for either cemented or uncemented use in individuals undergoing surgery for rehabilitating hip damage.","62054788 61901417 61984072 61901423 61901426 61901427 61901428 61901435 61901437 61278096 ",,"275,952 units","Some units of Trilogy shells manufactured since March 2009 may be below the lower range of the pore size specification (as low as 28% vs. 30% porosity specification). On 10/31/2012, the firm expanded the recall action to include lots of Uni-Hole Trilogy Acetabular System shells.",9/14/2012,"09/14/2012",2/13/2013,"02/13/2013"
"Devices",63531,"Ongoing","Zimmer, Inc.","Warsaw","IN","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution-USA (nationwide) and the countries of Denmark, Germany, Greece, Hungary, Ireland, Italy, Netherlands, Spain, Sweden, UK, Poland, France, Australia, Chile, Canada, India, Japan, New Zealand, Peru, South Africa, Colombia, Ukraine, and UAE.","Z-0775-2013","Class II","Trilogy Acetabular Shells with Holes. The Trilogy Acetabular System is indicated for either cemented or uncemented use in individuals undergoing surgery for rehabilitating hip damage. ","61567730 61558081 61611792 61559843 61567731 61611793 61215883 00369728 00369696 61930401 61459870 61611794 61564135 61201896 61292658 61783434 61915194 00369729 00369680 61921675 61638695 61915195 61906180 61808994 61425796 61580824 61471012 61263144 61201897 00369730 00370028 00370201 00370605 00370449 00369628 61996704 61779026 61533558 61758219 61455810 61452211 61911378 61596869 61734419 61783435 61794928 61201845 61783436 62055820 61580825 61825846 62022693 61580826 61638696 61889255 61263146 61281167 61321048 61329084 61471011 61638699 61896724 61921677 61283615 61309774 61215878 61216899 61638698 61855181 61906445 62052789 61374925 61638697 61199815 61199814 61403503 61412019 61486653 61521911 61533559 61580827 61633747 61817461 61921676 61957085 61263145 61412020 61470969 61486654 61809006 61292660 61237662 61374926 61452210 61528582 61837767 61873598 61930403 61945055 62006515 62052788 00370200 00369694 00370606 61732766 62063917 61374929 61454830 61360114 61500667 61808989 61996705 61734247 61635717 61640790 61920504 61716307 62022695 61215901 61949819 61215902 61397892 61486655 61580830 61635718 61779021 61882566 61638701 61709187 61884425 61201851 61271311 61374927 61454832 61483179 61533563 61761996 61783437 61825847 61832823 61957087 61957088 62038296 61803761 61846473 61873601 61999739 61425778 61439219 61455776 61528584 61533562 61580828 61638702 61640789 61750751 61846472 61878440 61528585 61783438 61945056 62055823 61281168 61283616 61292661 61368469 61439218 61454831 61486656 61533561 61542694 61542695 61580832 61580833 61640786 61640787 61820780 61846474 61860441 61895514 61941700 62063918 61397895 61454829 61709189 61842601 61860440 61867233 61911379 61216902 61263148 61263149 61269930 61271310 61283617 61309777 61374928 61397896 61412021 61497356 61533560 61564136 61580831 61611812 61638703 61716305 61761995 61803760 61808988 61867232 61906446 61921678 61947557 62022696 61825848 61939314 61216901 61260601 61292662 61309776 61329085 61340386 61342477 61374930 61397894 61403504 61455777 61",,"275,952 units","Some units of Trilogy shells manufactured since March 2009 may be below the lower range of the pore size specification (as low as 28% vs. 30% porosity specification). On 10/31/2012, the firm expanded the recall action to include lots of Uni-Hole Trilogy Acetabular System shells.",9/14/2012,"09/14/2012",2/13/2013,"02/13/2013"
"Devices",63531,"Ongoing","Zimmer, Inc.","Warsaw","IN","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution-USA (nationwide) and the countries of Denmark, Germany, Greece, Hungary, Ireland, Italy, Netherlands, Spain, Sweden, UK, Poland, France, Australia, Chile, Canada, India, Japan, New Zealand, Peru, South Africa, Colombia, Ukraine, and UAE.","Z-0772-2013","Class II","Trilogy Acetabular Shell Spiked. The Trilogy Acetabular System is indicated for either cemented or uncemented use in individuals undergoing surgery for rehabilitating hip damage.","00369642 00369648 00370032 00369656 61642334 00369644 61832805 61817455 61269936 61412631 61630564 00369407 61642337 61324694 61630563 61269937 61825837 61548181 61846490 61941029 61952408 61329095 61421263 61548182 61642336 60983133 61237717 61421264 00369660 61734272 62001310 61873606 61548185 61237808 61548184 61642338 60919315 61421260 61955590 61548186 61825841 61215919 61321081 61846488 61421258 61762005 61469142 61803767 61212922 61324695 61630550 61269940 61269941 61431735 61469143 61548190 61642339 61630567 61246475 61548191 61630565 61269943 61734270 60983134 61803771 61235835 61324696 61235836 61955591 61321084 61517446 61842609 61869695 00369695 61469149 61215920 61642341 61630551 61548201 61809017 61421267 61548199 61251222 61421266 61783461 61803769 61947736 61952415 61199836 61199839 61283453 61283454 61921683 00369661 61469151 61548205 61952422 61630552 61809012 61642342 61548206 61237809 61923871 61925091 61783462 61403530 61283455 61191067 00370048 00369663 61469152 61215929 61548212 61630569 61923872 61630553 00369638 61469154 00369651 00370752 61975586 00369664 11001720 61490760 62023765 61742082 61222252 61271664 61511137 61629985 61667049 61769838 61844002 61955479 61979981 61227814 61676615 61236278 61549718 61721127 61550409 62159365 61714399 11002260 62052850 07892033 61843998 61384952 61442061 61499614 61532992 61629982 61667062 61754419 61980115 61549720 61461917 61784734 62054500 61511139 61676596 61742071 61857680 61962840 62136223 61203311 62126090 61384953 61979983 07892046 61416489 61737672 61354833 61330560 61456504 62023767 61442060 61354834 07892052 61375761 61450049 62030472 61531423 61581705 ",,"275,952 units","Some units of Trilogy shells manufactured since March 2009 may be below the lower range of the pore size specification (as low as 28% vs. 30% porosity specification). On 10/31/2012, the firm expanded the recall action to include lots of Uni-Hole Trilogy Acetabular System shells.",9/14/2012,"09/14/2012",2/13/2013,"02/13/2013"
"Devices",63531,"Ongoing","Zimmer, Inc.","Warsaw","IN","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution-USA (nationwide) and the countries of Denmark, Germany, Greece, Hungary, Ireland, Italy, Netherlands, Spain, Sweden, UK, Poland, France, Australia, Chile, Canada, India, Japan, New Zealand, Peru, South Africa, Colombia, Ukraine, and UAE.","Z-0773-2013","Class II","Trilogy Acetabular Shell with Cluster Holes. The Trilogy Acetabular System is indicated for either cemented or uncemented use in individuals undergoing surgery for rehabilitating hip damage.","00369733 00369629 61216911 61750773 61770610 61734420 61880355 61941709 61687733 61076227 61489318 61716316 61825784 62063923 61215851 61216909 61263156 61483182 61655830 61709193 61825783 61855188 61957104 61580848 61943340 62065253 62076915 61215855 61655829 61655831 61783469 61873616 61883392 61883393 61964702 61978754 61439036 61911394 62052806 61957102 61215850 61263155 61374949 61511679 61536418 61665446 61716314 61734423 61768199 61783470 61801116 61860445 61864074 61864075 61916323 61938318 61991357 61435495 62010623 61967998 62063924 61216912 61256547 61310909 61483181 61528587 61580847 61580856 61655832 61665445 61673515 61687736 61687737 61687738 61709191 61709195 61744559 61750775 61783468 61794947 61817467 61825786 61846496 61936095 61941382 61999744 61999746 62065252 61237816 61846498 61911393 62052805 61066740 61237813 61237818 61237819 61246512 61246513 61281211 61292688 61350523 61360120 61407892 61417319 61417320 61439040 61487484 61489317 61497389 61511678 61511682 61528591 61542704 61542705 61542706 61665437 61675891 61687735 61709194 61716311 61716312 61734422 61779045 61801115 61817466 61825785 61846495 61846497 61867244 61867245 61881178 61884422 61926356 61934256 61949820 61953119 61999743 61999745 61360117 61439035 61873615 61941383 61978755 62010624 61880358 61263157 61263159 61281209 61283578 61283579 61360119 61360121 61397916 61397917 61407891 61417318 61429477 61439033 61454837 61454838 61454839 61483184 61487486 61489321 61511681 61521915 61528589 61528593 61536415 61536416 61564183 61564184 61580857 61655827 61665436 61665438 61687739 61709190 61716310 61716313 61750774 61809034 61880356 61880357 61934260 61952442 61957101 62036848 62036849 62076914 61292412 61397920 61412058 61528590 61817468 61916324 61939317 61271328 61489316 61884423 61201906 61215853 61216910 61237814 61237815 61237817 61246484 61256546 61260613 61260614 61263154 61263158 61271327 61271329 61281213 61283580 61292686 61292687 61292689 61310908 61324697 61324698 61324699 61324701 61329096 61329097 61350521 61"," 61231144 61231146 61236245 61236246 61236248 61236249 61236250 61236251 61236252 61269012 61278066 61278067 61278070 61330647 61330648 61333102 61346652 61346654 61360755 61371930 61371931 61375759 61381470 61403331 61410413 61410414 61419066 61419067 61422950 61422951 61422952 61422953 61429367 61456491 61476215 61480727 61480728 61488241 61488242 61488243 61488244 61488245 61511157 61511158 61511159 61514352 61514353 61566840 61574186 61574187 61581971 61596103 61603366 61639551 61645216 61645217 61656318 61658798 61658824 61667059 61670778 61670782 61680960 61684948 61709303 61714398 61721139 61726614 61726622 61737668 61737669 61742074 61748058 61754424 61761504 61769847 61772412 61780751 61784844 61791911 61796128 61796129 61807721 61807722 61813377 61819011 61819018 61821401 61838676 61838682 61843997 61851618 61857678 61860180 61879041 61926651 61930221 61935789 61946330 61955483 61962832 61962833 61962834 61979982 61980114 61992775 61998852 62011470 62011498 62016973 62042215 62045782 62049521 62049522 62052904 62056759 62067322 62073335 61384927 61476216 61461913 61461923 61469645 00108987 07892037 61461914 61511164 61514364 61992754 62093301 62093302 62084418 62115271 62143481 62078808 62093304 62093305 62115270 62127075 62127076 62152910 61498735 61217912 61217913 61231147 61231148 61236255 61236260 61271660 61278071 61278072 61381472 61429368 61658799 61992755 62016974 07892039 61278073 07892038 07892040 61206433 61206435 61209113 61209114 61227812 61231149 61236253 61236254 61236256 61236257 61236258 61236259 61236261 61271659 61278074 61330650 61330651 61333103 61338641 61360707 61360756 61360766 61371932 61371933 61381463 61381473 61384928 61398115 61398141 61403332 61403333 61416483 61429369 61450021 61450022 61450023 61456492 61456499 61476217 61480729 61483452 61483453 61488246 61488247 61488248 61498727 61499625 61511160 61511161 61549740 61549745 61553786 61576465 61576472 61585977 61585978 61589928 61603367 61603368 61629978 61633337 61645207 61645209 61648312 61648313 61658825 61670783 6","275,952 units","Some units of Trilogy shells manufactured since March 2009 may be below the lower range of the pore size specification (as low as 28% vs. 30% porosity specification). On 10/31/2012, the firm expanded the recall action to include lots of Uni-Hole Trilogy Acetabular System shells.",9/14/2012,"09/14/2012",2/13/2013,"02/13/2013"
"Devices",63531,"Ongoing","Zimmer, Inc.","Warsaw","IN","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution-USA (nationwide) and the countries of Denmark, Germany, Greece, Hungary, Ireland, Italy, Netherlands, Spain, Sweden, UK, Poland, France, Australia, Chile, Canada, India, Japan, New Zealand, Peru, South Africa, Colombia, Ukraine, and UAE.","Z-0771-2013","Class II","Trilogy F/M Acetabular Shell with Uni-Hole. The Trilogy Acetabular System is indicated for either cemented or uncemented use in individuals undergoing surgery for rehabilitating hip damage.","61282267 61633887 61260645 61237937 61500763 61397941 61584769 61199849 61429445 61412089 00369745 ",,"275,952 units","Some units of Trilogy shells manufactured since March 2009 may be below the lower range of the pore size specification (as low as 28% vs. 30% porosity specification). On 10/31/2012, the firm expanded the recall action to include lots of Uni-Hole Trilogy Acetabular System shells.",9/14/2012,"09/14/2012",2/13/2013,"02/13/2013"
"Veterinary",63537,"Terminated","HBD International","Brentwood","TN","US","Voluntary: Firm Initiated","Telephone","OR","V-125-2013","Class I","WILD WINGS, CERTIFIED ORGANIC, PREMIUM ORGANIC BLEND, PREMIUM SEED FOR BIRDS, Net wt. 80 oz (5 lbs) (2.27 kg), HBD INTERNATIONAL, 7108 CROSSROADS BLVD., SUITE 325 BRENTWOOD, TN 37027, 615.221.9890 800.346.0269","POM9512WL2201A4",".","36 units","Product was manufactured with peanuts recalled by Sunland due to the potential for salmonella contamination.",10/26/2012,"10/26/2012",1/23/2013,"01/23/2013"
"Drugs",63548,"Ongoing","Hospira Inc.","Lake Forest","IL","US","Voluntary: Firm Initiated","Letter","Nationwide and Puerto Rico.","D-153-2013","Class I","Carboplatin Injection, 600 mg/60 mL (10 mg/mL), 60 mL, Cytotoxic Agent, Sterile, Multi-Dose Vial, Rx only, For IV Use, Hospira, Inc., Lake Forest, IL 60045, Product of Australia, NDC 61703-339-56.","Lot #: Z021650AA, Exp. 08/2013",,"23,315 vials","Crystallization: Product is being recalled due to visible particulates identified during a retain sample inspection. Findings have identified the particles as Carboplatin crystals.",11/8/2012,"11/08/2012",2/13/2013,"02/13/2013"
"Drugs",63548,"Ongoing","Hospira Inc.","Lake Forest","IL","US","Voluntary: Firm Initiated","Letter","Nationwide and Puerto Rico.","D-154-2013","Class I","Carboplatin Injection, 450 mg/45 mL (10 mg/mL), 45 mL, Cytotoxic Agent, Sterile, Multi-Dose Vial, Rx only, For IV Use, NDC 61703-339-50 (Hospira label) and NDC 61703-360-50 (Novaplus label), Hospira, Inc., Lake Forest, IL 60045, Product of Australia.","lots Z011711AA (Hospira label) and Z011711AB (Novaplus label), Exp. 08/2013",,"31,326 vials","Crystallization: Product is being recalled due to visible particulates identified during a retain sample inspection. Findings have identified the particles as Carboplatin crystals.",11/8/2012,"11/08/2012",2/13/2013,"02/13/2013"
"Devices",63551,"Ongoing","Instratek, Incorporated","Houston","TX","US","Voluntary: Firm Initiated","Letter","USA Nationwide Distribution including the states of: AZ, MI, NE, NV, and TX.","Z-0922-2013","Class II","Endotrig Trigger Release Sterile Micro Hook Blade Product Usage: The blade is intended to release A-1 pulley in endoscopic trigger release procedures. ","Model number 1052; Lots M674180, MAKL170, M674200",,"235","Instratek, Inc.has received multiple complaints of the 1052 Trigger Finger Release Blades which could not be advanced into the cannula through which it is used during trigger finger release procedures.",9/18/2012,"09/18/2012",3/20/2013,"03/20/2013"
"Devices",63555,"Completed","Remel Inc","Lenexa","KS","US","Voluntary: Firm Initiated","Letter","Nationwide Distribution including WI, MO, MA, CT, AL, IL, WA, CA, RI, MD, NJ, NC and TX.","Z-0790-2013","Class II","Oxoid Antimicrobial Susceptibility Test Discs, Aztreonam 30 ug, IVD, REF CT0264B, Oxoid Ltd., UK, oxoid@thrmofisher.com (Both Remel & Oxoid, Ltd are a part of Thermo Fisher Scientific) An antimicrobial susceptibility test disc is a device that consists of antimicrobic-impregnated paper discs used to measure, by a disc-agar diffusion technique or a disc-broth elution technique, the in vitro susceptibility of most clinically important bacterial pathogens to antimicrobial agents (Aztreonam).","Lot 1100699",,"30","The firm is recalling the product due to some cartridges may contain individual discs that are not impregnated with antibiotic. The firm notified their customers of the recall with a notification letter and requested a confirmation fax back of receipt.",8/21/2012,"08/21/2012",2/13/2013,"02/13/2013"
"Devices",63559,"Ongoing","Zimmer, Inc.","Warsaw","IN","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Worldwide Distribution","Z-0659-2013","Class II","The TM Ardis Interbody System Inserter Stainless Steel, Rubber, Silicone Non Sterile Rx only. The TM Ardis Inserter is intended for delivery of the TM Ardis Implant into the cleared disc space. The implant is secured to the inserter via finger-tightening the knob of the inserter shaft allowing the lateral grasping arms to secure the implant. Once the implant is inserted and its position confirmed radiographically, the inserter is removed from the implant by turning the shaft knob counterclockwise to loosen the lateral grasping arms from the implant.","Part number: 96-701-10001; Lot numbers: " 61946711, 61946712, 61991588, 62000412,",".","170","Zimmer Spine, Inc. is initiating a voluntary medical device correction to the Surgical Technique (L1607) for the TM Ardis Inserter because Zimmer has received complaints reporting difficulty in turning the implant release knob after final positioning of the TM Ardis interbody spacer implant. There has been two reports where the inserter instrument was inadvertently removed from the patient with the implant still engaged. The correction includes revised directions explaining the technique to remove the implant from the inserter.",9/20/2012,"09/20/2012",1/16/2013,"01/16/2013"
"Biologics",63560,"Terminated","Community Blood Centers of South Florida, Inc.","Hialeah","FL","US","Voluntary: Firm Initiated","Letter","Florida","B-0380-13","Class II","Red Blood Cells","1501084; ",".","1 unit","Blood product, collected from a donor for whom donor suitability was not adequately determined, was distributed.",9/6/2012,"09/06/2012",1/30/2013,"01/30/2013"
"Biologics",63561,"Terminated","Community Blood Centers of Florida, Inc.","Miami","FL","US","Voluntary: Firm Initiated","Letter","Florida","B-0381-13","Class II","Red Blood Cells","2782441; ",".","1 unit","Blood products, which were collected from a donor in which donor suitability was not adequately determined, were distributed.",9/7/2012,"09/07/2012",1/30/2013,"01/30/2013"
"Biologics",63561,"Terminated","Community Blood Centers of Florida, Inc.","Miami","FL","US","Voluntary: Firm Initiated","Letter","Florida","B-0383-13","Class II","Platelets Pooled Leukocytes Reduced","2939678; ",".","1 unit","Blood products, which were collected from a donor in which donor suitability was not adequately determined, were distributed.",9/7/2012,"09/07/2012",1/30/2013,"01/30/2013"
"Biologics",63561,"Terminated","Community Blood Centers of Florida, Inc.","Miami","FL","US","Voluntary: Firm Initiated","Letter","Florida","B-0382-13","Class II","Fresh Frozen Plasma","2782441; ",".","1 unit","Blood products, which were collected from a donor in which donor suitability was not adequately determined, were distributed.",9/7/2012,"09/07/2012",1/30/2013,"01/30/2013"
"Biologics",63563,"Terminated","Blood Bank Of Hawaii","Honolulu","HI","US","Voluntary: Firm Initiated","FAX","Hawaii","B-0384-13","Class II","Red Blood Cells","W088412540032; ",".","1 unit","Blood product, collected from a donor who traveled to an area considered endemic for malaria, was distributed.",9/10/2012,"09/10/2012",1/30/2013,"01/30/2013"
"Biologics",63564,"Terminated","Community Blood Center of Carolinas","Charlotte","NC","US","Voluntary: Firm Initiated","Telephone","North Carolina","B-0385-13","Class II","Platelets Pheresis Leukocytes Reduced Irradiated","W227012026550; ",".","1 unit","Blood product, which was not tested to verify the pH and White Blood Cell count, was distributed.",10/5/2012,"10/05/2012",1/30/2013,"01/30/2013"
"Biologics",63565,"Terminated","BioLife Plasma Services, L.P.","Hayden","ID","US","Voluntary: Firm Initiated","Other","California","B-0389-13","Class II","Source Plasma","12HIDD6894; 12HIDD6268; 12HIDD4985; 12HIDD4469; 12HIDD3145; 12HIDD2431; 12HIDD1162; 12HIDD0429; 12HIDC9138; 12HIDC8510; ",".","10 units","Blood products, collected from a donor who did not have a complete physical examination, were distributed.",9/5/2012,"09/05/2012",1/30/2013,"01/30/2013"
"Biologics",63566,"Completed","Community Blood Center of the Ozarks","Springfield","MO","US","Voluntary: Firm Initiated","Letter","North Carolina; Austria; Missouri; Arkansas; Indiana","B-0513-13","Class II","Blood and Blood Products for Reprocessing","W045112343677; W045111224055; W045110188169; ",".","3 units","Blood products, collected from a donor who was in close contact with an individual diagnosed with Hepatitis B, were distributed.",10/2/2012,"10/02/2012",1/30/2013,"01/30/2013"
"Biologics",63566,"Completed","Community Blood Center of the Ozarks","Springfield","MO","US","Voluntary: Firm Initiated","Letter","North Carolina; Austria; Missouri; Arkansas; Indiana","B-0512-13","Class II","Red Blood Cells Leukocytes Reduced","W045112343677; W045111224055; W045110188169; W045110186446; ",".","4 units","Blood products, collected from a donor who was in close contact with an individual diagnosed with Hepatitis B, were distributed.",10/2/2012,"10/02/2012",1/30/2013,"01/30/2013"
"Biologics",63566,"Completed","Community Blood Center of the Ozarks","Springfield","MO","US","Voluntary: Firm Initiated","Letter","North Carolina; Austria; Missouri; Arkansas; Indiana","B-0510-13","Class II","Plasma Frozen within 24 hours (FP24)","W045110186446; W045110138504; ",".","2 units","Blood products, collected from a donor who was in close contact with an individual diagnosed with Hepatitis B, were distributed.",10/2/2012,"10/02/2012",1/30/2013,"01/30/2013"
"Biologics",63566,"Completed","Community Blood Center of the Ozarks","Springfield","MO","US","Voluntary: Firm Initiated","Letter","North Carolina; Austria; Missouri; Arkansas; Indiana","B-0511-13","Class II","Red Blood Cells","W045110138504; ",".","1 unit","Blood products, collected from a donor who was in close contact with an individual diagnosed with Hepatitis B, were distributed.",10/2/2012,"10/02/2012",1/30/2013,"01/30/2013"
"Biologics",63567,"Terminated","Blood Assurance Inc","Chattanooga","TN","US","Voluntary: Firm Initiated","FAX","Tennessee; Indiana","B-0390-13","Class II","Red Blood Cells Leukocytes Reduced","W043212004915; ",".","1 unit","Blood products, collected from a donor whose suitability to donate was not adequately determined, were distributed.",9/10/2012,"09/10/2012",1/30/2013,"01/30/2013"
"Biologics",63567,"Terminated","Blood Assurance Inc","Chattanooga","TN","US","Voluntary: Firm Initiated","FAX","Tennessee; Indiana","B-0391-13","Class III","Blood and Blood Products for Reprocessing","W043212004915; ",".","1 unit","Blood products, collected from a donor whose suitability to donate was not adequately determined, were distributed.",9/10/2012,"09/10/2012",1/30/2013,"01/30/2013"
"Biologics",63568,"Terminated","BioLife Plasma Services, L.P.","Hayden","ID","US","Voluntary: Firm Initiated","Other","California","B-0393-13","Class II","Source Plasma","12HIDC6420; ",".","1 unit","Blood product, collected from a donor who did not have a complete physical examination, was distributed.",9/25/2012,"09/25/2012",1/30/2013,"01/30/2013"
"Biologics",63569,"Terminated","American National Red Cross, Penn-Jersey Region","Philadelphia","PA","US","Voluntary: Firm Initiated","FAX","Pennsylvania; New Jersey","B-0396-13","Class II","Platelets Pheresis Leukocytes Reduced Irradiated","22FL28810PART1; 22FL28810PART2; 22FL28699PART2; ",".","3 units","Blood products, collected using equipment that had not been validated, were distributed. ",9/7/2012,"09/07/2012",1/30/2013,"01/30/2013"
"Biologics",63569,"Terminated","American National Red Cross, Penn-Jersey Region","Philadelphia","PA","US","Voluntary: Firm Initiated","FAX","Pennsylvania; New Jersey","B-0397-13","Class II","Platelets Pheresis Leukocytes Reduced","22FL28725PART1; 22FL28725PART2; 22FL28699PART1; 22FL28679PART1; ",".","4 units","Blood products, collected using equipment that had not been validated, were distributed. ",9/7/2012,"09/07/2012",1/30/2013,"01/30/2013"
"Biologics",63570,"Terminated","Blood Assurance Inc","Chattanooga","TN","US","Voluntary: Firm Initiated","FAX","Tennessee; Indiana","B-0395-13","Class III","Blood and Blood Products for Reprocessing","W043212025175; ",".","1 unit","Blood products, which were collected from a donor in which donor suitability was not adequately determined, were distributed.",10/11/2012,"10/11/2012",1/30/2013,"01/30/2013"
"Biologics",63570,"Terminated","Blood Assurance Inc","Chattanooga","TN","US","Voluntary: Firm Initiated","FAX","Tennessee; Indiana","B-0394-13","Class II","Red Blood Cells Leukocytes Reduced","W043212025175; ",".","1 unit","Blood products, which were collected from a donor in which donor suitability was not adequately determined, were distributed.",10/11/2012,"10/11/2012",1/30/2013,"01/30/2013"
"Biologics",63571,"Terminated","Community Blood Center","Dayton","OH","US","Voluntary: Firm Initiated","Telephone","OH","B-0359-13","Class II","Red Blood Cells","W035412060950",,"1 unit","Blood product, collected from a donor who had a previous history of travel to a malarial endemic area, was distributed.",9/4/2012,"09/04/2012",3/13/2013,"03/13/2013"
"Biologics",63572,"Terminated","LifeSouth Community Blood Centers Inc","Huntsville","AL","US","Voluntary: Firm Initiated","FAX","AL","B-0448-13","Class II","Red Blood Cells (Apheresis) Leukocytes Reduced","W1151122758236- part 1; W1151122758236- part 2",,"2 units","Blood products, which were not quarantined subsequent to receiving post donation illness information, were distributed.",9/26/2012,"09/26/2012",3/13/2013,"03/13/2013"
"Biologics",63573,"Terminated","LifeSouth Community Blood Centers, Inc.","Gainesville","FL","US","Voluntary: Firm Initiated","FAX","FL","B-0447-13","Class II","Platelets Pheresis Leukocytes Reduced","W115112327021R",,"1 unit","Blood product, labeled leukoreduced but was not tested to verify the White Blood Cell count, was distributed.",9/26/2012,"09/26/2012",3/13/2013,"03/13/2013"
"Biologics",63575,"Terminated","LifeSouth Community Blood Centers Inc - Birmingham Region","Birmingham","AL","US","Voluntary: Firm Initiated","FAX","AL","B-0446-13","Class II","Platelets Pheresis Leukocytes Reduced","W115112282932C",,"1 unit","Blood product, which did not meet acceptable product specifications, was distributed.",10/1/2012,"10/01/2012",3/13/2013,"03/13/2013"
"Biologics",63576,"Terminated","LifeSouth Community Blood Centers, Inc.","Gainesville","FL","US","Voluntary: Firm Initiated","FAX","AL,FL","B-0480-13","Class II","Platelets Pheresis Leukocytes Reduced","W115112277608P- part 1; W115112277608P-part 2 ",,"2 units","Blood products, which did not meet the acceptable product specifications for release, were distributed.",9/24/2012,"09/24/2012",3/13/2013,"03/13/2013"
"Biologics",63578,"Terminated","LifeSouth Community Blood Centers, Inc.","Gainesville","FL","US","Voluntary: Firm Initiated","FAX","AL","B-0481-13","Class II","Platelets Pheresis Leukocytes Reduced","W115112277116S",,"1 unit","Platelet, with a low platelet count, was distributed. ",9/6/2012,"09/06/2012",3/13/2013,"03/13/2013"
"Biologics",63579,"Terminated","Lane Memorial Blood Bank","Eugene","OR","US","Voluntary: Firm Initiated","Letter","Tennessee; Oregon","B-0477-13","Class II","Red Blood Cells Leukocytes Reduced","W137512105036; W137512107334",,"2 units","Blood products, collected from a donor who had traveled to a malarial endemic area, were distributed.",9/24/2012,"09/24/2012",3/13/2013,"03/13/2013"
"Drugs",63589,"Ongoing","Hospira Inc.","Lake Forest","IL","US","Voluntary: Firm Initiated","Letter","Nationwide","D-106-2013","Class II","Epinephrine Injection USP, 1 mL, USP 1:1000 (1 mg/mL), SQ/IM, Hospira, Inc., Lake Forest, IL --- NDC 0409-7241-01","Lot 100953A, Exp 01OCT2013; Lot 120803A Exp 01DEC2013",".","361,600/1-mL ampules","Presence of Particulates; may contain glass particles",10/25/2012,"10/25/2012",1/9/2013,"01/09/2013"
"Biologics",63590,"Terminated","Community Blood Centers of Florida, Inc.","Lauderhill","FL","US","Voluntary: Firm Initiated","FAX","Switzerland; FL","B-0270-13","Class III","Blood and Blood Products for Reprocessing","2533388",,"1 unit","Blood products, which were collected from a donor in which donor suitability was not adequately determined, were distributed.",10/2/2012,"10/02/2012",3/13/2013,"03/13/2013"
"Biologics",63590,"Terminated","Community Blood Centers of Florida, Inc.","Lauderhill","FL","US","Voluntary: Firm Initiated","FAX","Switzerland; FL","B-0269-13","Class II","Red Blood Cells","2533388",,"1 unit","Blood products, which were collected from a donor in which donor suitability was not adequately determined, were distributed.",10/2/2012,"10/02/2012",3/13/2013,"03/13/2013"
"Biologics",63591,"Terminated","D. D. Eisenhower Army Med. Ctr. - Blood Bank","Fort Gordon","GA","US","Voluntary: Firm Initiated","Letter","NJ, FL","B-0479-13","Class II","Blood and Blood Products for Reprocessing","W010712004910 ",,"1 unit","Blood products, collected from a donor considered to be at risk for variant Creutzfeldt-Jakob Disease (vCJD), were distributed. ",9/27/2012,"09/27/2012",3/13/2013,"03/13/2013"
"Biologics",63591,"Terminated","D. D. Eisenhower Army Med. Ctr. - Blood Bank","Fort Gordon","GA","US","Voluntary: Firm Initiated","Letter","NJ, FL","B-0478-13","Class II","Red Blood Cells","W010712004910; ",,,,9/27/2012,"09/27/2012",3/13/2013,"03/13/2013"
"Biologics",63592,"Terminated","Community Blood Centers of South Florida, Inc.","Hialeah","FL","US","Voluntary: Firm Initiated","FAX","Switzerland and FL","B-0474-13","Class II","Red Blood Cells Leukocytes Reduced","W036811258578",,"1 unit","Blood products, which were collected from a donor in which donor suitability was not adequately determined, were distributed.",9/20/2012,"09/20/2012",3/13/2013,"03/13/2013"
"Biologics",63592,"Terminated","Community Blood Centers of South Florida, Inc.","Hialeah","FL","US","Voluntary: Firm Initiated","FAX","Switzerland and FL","B-0475-13","Class III","Blood and Blood Products for Reprocessing","W036811258578; W036810173369",,"2 units","Blood products, which were collected from a donor in which donor suitability was not adequately determined, were distributed.",9/20/2012,"09/20/2012",3/13/2013,"03/13/2013"
"Biologics",63592,"Terminated","Community Blood Centers of South Florida, Inc.","Hialeah","FL","US","Voluntary: Firm Initiated","FAX","Switzerland and FL","B-0476-13","Class II","Red Blood Cells","W036810173369",,"1 unit","Blood products, which were collected from a donor in which donor suitability was not adequately determined, were distributed.",9/20/2012,"09/20/2012",3/13/2013,"03/13/2013"
"Biologics",63593,"Terminated","Community Blood Centers of Florida, Inc.","Lauderhill","FL","US","Voluntary: Firm Initiated","Letter","Florida","B-0413-13","Class II","Red Blood Cells Leukocytes Reduced","W036812426425; ",".","1","Blood product, which was collected from a donor in which donor suitability was not adequately determined, was distributed.",9/18/2012,"09/18/2012",2/6/2013,"02/06/2013"
"Biologics",63594,"Terminated","Puget Sound Blood Center and Program","Seattle","WA","US","Voluntary: Firm Initiated","Letter","Washington","B-0426-13","Class III","Red Blood Cells","W141610132562; ",".","1","Blood product, collected from a donor, whose suitability to donate was not adequately determined, was distributed.",9/7/2012,"09/07/2012",2/6/2013,"02/06/2013"
"Biologics",63595,"Terminated","Puget Sound Blood Center and Program","Seattle","WA","US","Voluntary: Firm Initiated","Letter","Washington","B-0427-13","Class II","Red Blood Cells Leukocytes Reduced Irradiated","W141610155472; ",".","1","Blood products, collected from donors, whose suitability to donate was not adequately determined, were distributed.",9/12/2012,"09/12/2012",2/6/2013,"02/06/2013"
"Biologics",63595,"Terminated","Puget Sound Blood Center and Program","Seattle","WA","US","Voluntary: Firm Initiated","Letter","Washington","B-0429-13","Class II","Red Blood Cells","W141610157832; W141610157430; ",".","2","Blood products, collected from donors, whose suitability to donate was not adequately determined, were distributed.",9/12/2012,"09/12/2012",2/6/2013,"02/06/2013"
"Biologics",63595,"Terminated","Puget Sound Blood Center and Program","Seattle","WA","US","Voluntary: Firm Initiated","Letter","Washington","B-0428-13","Class II","Fresh Frozen Plasma","W141610154831; ",".","1","Blood products, collected from donors, whose suitability to donate was not adequately determined, were distributed.",9/12/2012,"09/12/2012",2/6/2013,"02/06/2013"
"Devices",63602,"Ongoing","Stryker Medical Division of Stryker Corporation","Portage","MI","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Worldwide Distribution - Nationwide and Canada","Z-0629-2013","Class II","Medical Surgical Bed, Model 3005S3EX Medical Surgical Bed The S3'' MedSurg Bed, Model 3005 is intended to support and transport patients within the Med/Surg and Critical Care hospital environments. The bed is typically used in pre-op, post-op and recovery areas of hospital facilities. The intended user for this product is both Health Care Providers (HCPs: nurses, nurses aides, and medical doctors) and human patients. Lockout features may limit patient accessible controls. ","Model 3005S3EX, Serial Number 120415087 - 120515468,",".","1004","Stryker Medical Model 3002S3EX and Model 3005S3EX beds built between March 15, 2012 and May 23, 2012. may have been built with brake rings that do not meet specifications, negatively impacting the holding force of the brakes. ",12/18/2012,"12/18/2012",1/9/2013,"01/09/2013"
"Devices",63602,"Ongoing","Stryker Medical Division of Stryker Corporation","Portage","MI","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Worldwide Distribution - Nationwide and Canada","Z-0628-2013","Class II","Medical Surgical Bed, Model 3002SEX Medical Surgical Bed The S3'' MedSurg Bed, is intended to support and transport patients within the Med/Surg and Critical Care hospital environments. The bed is typically used in pre-op, post-op and recovery areas of hospital facilities. The intended user for this product is both Health Care Providers (HCPs: nurses, nurses aides, and medical doctors) and human patients. Lockout features may limit patient accessible controls","Model 3002SEX, Serial Number 120315371-120315379",".","9","Stryker Medical Model 3002S3EX and Model 3005S3EX beds built between March 15, 2012 and May 23, 2012. The affected beds may have been built with brake rings that do not meet specifications, negatively impacting the holding force of the brakes. ",12/18/2012,"12/18/2012",1/9/2013,"01/09/2013"
"Devices",63605,"Ongoing","Beckman Coulter Inc.","Brea","CA","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution-USA (nationwide) and Puerto Rico and the countries of Germany, China, Austria, Brazil, Italy, Argentina, Korea, Vietnam, Hungary, Ireland, France, Spain, Turkey, Switzerland, Israel, Australia, India, United Kingdom, Netherlands, Malaysia, Russian Federation, Japan, Taiwan, and Canada","Z-1873-2013","Class II","Beckman Coulter AU5800 Clinical Chemistry Analyzer, All Serial Numbers. An automated chemistry analyzer that measures analytes in samples, in combination with appropriate reagents, calibrators, quality control (QC), material and other accessories.","Models, Catalogue Numbers: AU5811-01, A94906; AU5811-02, A94907; AU5811-03, A94908; AU5811-04, A94909; AU5811-06, A94910; AU5821-01, A94911; AU5821-02, A94912; AU5821-03, A94913; AU5821-04, A94914; AU5821-06, A94915; AU5831-01, A94916; AU5831-02, A94917; AU5831-03, A94918; AU5831-04 A94919; AU5831-06 A94920; AU5831-01 A94921; AU5831-02 A94922; AU5831-03 A94923; AU5831-04 A94924; AU5831-06 A94925.",".","338 units (11 units in the US)","Beckman Coulter is recalling the AU8500 Clinical Chemistry Analyzer because there is no labeling on the diluted detergent tank to show the proper disposition of the on/off valve.",10/26/2012,"10/26/2012",8/14/2013,"08/14/2013"
"Veterinary",63606,"Ongoing","Wixon, Inc.","Saint Francis","WI","US","Voluntary: Firm Initiated","Letter","CA, IL, GA, NJ, CT, KS, MN, MA, WA, ME, NY.","V-128-2013","Class I","Charlee Bear Protein Crunch Bars, 84% Chicken Recipe with Carrots, 5.5 oz, UPC Code 8710890000.","Lot # 19812, 19912, 20012, 20212.",".","448 cases (12 pouches/case)","Charlee Bear Products, a division of Wixon, Inc., is voluntarily recalling certain lots of its Charlee Bear Protein Crunch Treats because they have the potential to be contaminated with Salmonella.",10/31/2012,"10/31/2012",1/23/2013,"01/23/2013"
"Veterinary",63606,"Ongoing","Wixon, Inc.","Saint Francis","WI","US","Voluntary: Firm Initiated","Letter","CA, IL, GA, NJ, CT, KS, MN, MA, WA, ME, NY.","V-127-2013","Class I","Charlee Bear Protein Crunch Bars, 84% Chicken Recipe with Sweet Potatoes, 5.5 oz, UPC Code 8710890001.","Lot # 20112",".","444 cases (12 pouches/case)","Charlee Bear Products, a division of Wixon, Inc., is voluntarily recalling certain lots of its Charlee Bear Protein Crunch Treats because they have the potential to be contaminated with Salmonella.",10/31/2012,"10/31/2012",1/23/2013,"01/23/2013"
"Drugs",63608,"Ongoing","Alara Pharmaceutical Co","San Juan","PR","US","Voluntary: Firm Initiated","Letter","Nationwide","D-104-2013","Class II","Levothyroxine Sodium Tablets, USP, 175 mcg in 90 ct bottles, Manufactured by Patheon Puerto Rico Inc., for Alara Pharmaceutical Corp, San Juan, PR","11T7011A, Exp. Date: 12/2012",".","7,432 bottles","Subpotent; 15 month stability",10/29/2012,"10/29/2012",1/2/2013,"01/02/2013"
"Devices",63616,"Ongoing","Mindray DS USA, Inc. d.b.a. Mindray North America","Mahwah","NJ","US","Voluntary: Firm Initiated","Letter","Nationwide Distribution including OH and GA","Z-0630-2013","Class II","DPM Central Station Mindray DS USA, Inc. 800 MacArthur Boulevard, Mahwah, NJ 07430 The Central Monitoring Station (CMS) network transfers information between DOM Central Station and other network devices. It also allows information transfer between several CMS. Network connections consist of hardwired network cables and or WLAN connections. The DPM Central Station is used for remote monitor management, storing, printing, reviewing, or processing of information from net worked devices, and it is operated by medical personnel in hospitals or medical institutions.","510 K K080192 P/N 300BF-PA200002",".","two units","There is a software anomaly with the DPM Central Monitoring System where the trend data of one patient maybe replaced with the trend data of a second patient.",5/12/2011,"05/12/2011",1/9/2013,"01/09/2013"
"Devices",63617,"Ongoing","Roche Diagnostics Operations, Inc.","Indianapolis","IN","US","Voluntary: Firm Initiated","Letter","Nationwide Distribution including AL, AR, AZ, CA, CT, DC, FL, GA, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI, and WY and GUAYNABO, PR.","Z-0696-2013","Class III","Roche COBAS INTEGRA 400 and 400 plus Analyzer The Roche COBAS INTEGRA 400/400 plus Analyzer is a fully automated system for clinical chemistry analysis intended for the in vitro quantitative/qualitative determination of analytes in body fluids.","Part Numbers:28065047001 and 03245233001",".","845 Units","A software security issue with Oracles TNS-Listener component has been identified. TNS-Listener is supplied with the Roche COBAS INTEGRA 400/400 plus Analyzers. The Oracle TNS-Listener can be considered as an authentication and redirection component between the client and the database inside the Roche product. This means an attacker could register their own non-Roche database via remote access over the network to the Roche product and read and write database queries without authentication and therefore modify the content of a database.",11/19/2012,"11/19/2012",1/30/2013,"01/30/2013"
"Devices",63621,"Completed","Smiths Medical ASD, Inc.","Saint Paul","MN","US","Voluntary: Firm Initiated","E-Mail","Distributed in the state of NH.","Z-0996-2013","Class II","Medfusion Model 3500 Syringe Pump, Model #3500-415 and 3500-500. Intended for use in critical care areas for the administration of fluids requiring precisely controlled infusion rates.","Lot/Serial Numbers: M76369, M76370, M76373, M76374, M76375, and M76377.",,"6","An issue with the plunger rod seal was identified where the seal had the potential to migrate inside the pump case top during slow rate/ high back pressure infusions.",5/14/2010,"05/14/2010",4/3/2013,"04/03/2013"
"Devices",63622,"Ongoing","J T Posey Company","Arcadia","CA","US","Voluntary: Firm Initiated",,"Nationwide Distribution","Z-1071-2013","Class II","Posey Biothane Restraint Cuffs, Catalog Number 2900. The device is intended to limit a patient's movement to the extent necessary for treatment or protection of the patient or others. ","The model/catalog number for the device is 2900. All lots are being recalled.",,"1673 units","The firm voluntarily recalled Biothane Restraint Cuffs, Catalog No. 2900, that did not meet the required specifications for tensile strength. Failure of these rivets could allow the cuff to become disconnected from the connecting strap and allow patients to regain free use of the limb.",10/31/2012,"10/31/2012",4/17/2013,"04/17/2013"
"Biologics",63625,"Terminated","Florida's Blood Centers, Inc.","Orlando","FL","US","Voluntary: Firm Initiated","Letter","Florida","B-0414-13","Class II","Red Blood Cells (Apheresis) Leukocytes Reduced","W038112114651A; W038112114651B; ",".","2","Blood products, collected from a donor who traveled to an area considered endemic for malaria, were distributed.",9/14/2012,"09/14/2012",2/6/2013,"02/06/2013"
"Biologics",63626,"Terminated","Carter BloodCare","Bedford","TX","US","Voluntary: Firm Initiated","FAX","New Jersey; Texas","B-0418-13","Class II","Platelets","W0352120385900; W035212226967D; ",".","2","Blood products, which were collected from a donor in which donor suitability was not adequately determined, were distributed.",10/5/2012,"10/05/2012",2/6/2013,"02/06/2013"
"Biologics",63626,"Terminated","Carter BloodCare","Bedford","TX","US","Voluntary: Firm Initiated","FAX","New Jersey; Texas","B-0417-13","Class II","Red Blood Cells Leukocytes Reduced","W0352120385900; ",".","1","Blood products, which were collected from a donor in which donor suitability was not adequately determined, were distributed.",10/5/2012,"10/05/2012",2/6/2013,"02/06/2013"
"Biologics",63626,"Terminated","Carter BloodCare","Bedford","TX","US","Voluntary: Firm Initiated","FAX","New Jersey; Texas","B-0419-13","Class III","Blood and Blood Products for Reprocessing","W0352120385900; ",".","1","Blood products, which were collected from a donor in which donor suitability was not adequately determined, were distributed.",10/5/2012,"10/05/2012",2/6/2013,"02/06/2013"
"Biologics",63627,"Terminated","Puget Sound Blood Center and Program","Seattle","WA","US","Voluntary: Firm Initiated","Letter","California; Washington","B-0420-13","Class II","Red Blood Cells Leukocytes Reduced","W141610018913; W141610048862; ",".","2","Blood products, collected from donors, whose suitability to donate was not adequately determined, were distributed. ",8/13/2012,"08/13/2012",2/6/2013,"02/06/2013"
"Biologics",63627,"Terminated","Puget Sound Blood Center and Program","Seattle","WA","US","Voluntary: Firm Initiated","Letter","California; Washington","B-0421-13","Class II","Red Blood Cells Leukocytes Reduced Irradiated","W141611017625; ",".","1","Blood products, collected from donors, whose suitability to donate was not adequately determined, were distributed. ",8/13/2012,"08/13/2012",2/6/2013,"02/06/2013"
"Devices",63632,"Ongoing","Beckman Coulter Inc.","Brea","CA","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution-USA (nationwide) and the country of Canada.","Z-0612-2013","Class II","Access Immunoassay System, Access 2 Immunoassay System, Synchron LXi 725 Clinical System, UniCel DxC 600i Synchron Access Clinical System Part Numbers: Access 81600; Access 2 81600N, 386220, A69186, A25656, A12900; Access 2 (LXi) A15642; Access 2 Section, DxC 600i A25640. The Access Immunoassay System is an in vitro diagnostic device used for the quantitative, semi-quantitative or qualitative determination of various analyte concentrations found in human body fluids. The Synchron LXi and the UniCel DxC 600i are Access systems integrated with a chemistry analyzer.","Part Numbers: Access 81600; Access 2 81600N, 386220, A69186, A25656, A12900; Access 2 (LXi) A15642; Access 2 Section, DxC 600i A25640",".","6,858 units","It has been determined that, in some cases, pulley drive components have broken parts or have become loose, mispositioned, or disconnected from their drive shafts. When these defects occur, the pulley may not turn at all, or may turn at an incorrect speed, resulting in inadequate washing or mixing of the contents of the reaction vessel.",11/1/2012,"11/01/2012",1/2/2013,"01/02/2013"
"Biologics",63636,"Terminated","LifeServe Blood Center","Des Moines","IA","US","Voluntary: Firm Initiated","Telephone","Iowa","B-0422-13","Class II","Platelets Pooled Leukocytes Reduced","W044112124744; ",".","1","Blood product, which tested negative for viral markers, but was collected from a donor that subsequently reported a previous history of positive test hepatitis, was distributed.",10/1/2012,"10/01/2012",2/6/2013,"02/06/2013"
"Biologics",63637,"Terminated","Community Blood Centers of Florida, Inc.","Lauderhill","FL","US","Voluntary: Firm Initiated","Telephone","Florida","B-0423-13","Class II","Platelets Pheresis Leukocytes Reduced","W036812538893; ",".","1","Blood product, which did not meet acceptable product specifications, was distributed.",9/19/2012,"09/19/2012",2/6/2013,"02/06/2013"
"Biologics",63638,"Terminated","Belle Bonfils Memorial Blood Center","Denver","CO","US","Voluntary: Firm Initiated","FAX","Colorado","B-0424-13","Class II","Red Blood Cells Leukocytes Reduced","W036212518486; ",".","1","Blood product, which was collected from a donor who had lived in a malarial endemic area, was distributed. ",10/1/2012,"10/01/2012",2/6/2013,"02/06/2013"
"Biologics",63639,"Terminated","Mississippi Valley Reg Bld Ctr","Davenport","IA","US","Voluntary: Firm Initiated","Telephone","Texas","B-0425-13","Class II","Platelets","W333612094877; ",".","1","Blood product, collected from a donor, whose suitability to donate was not adequately determined, was distributed.",9/25/2012,"09/25/2012",2/6/2013,"02/06/2013"
"Biologics",63644,"Terminated","American National Red Cross SW Region - HT","Tulsa","OK","US","Voluntary: Firm Initiated","FAX","Kansas","B-0442-13","Class III","Plasma Frozen within 24 hours (FP24)","02K71938",".","1 unit","Blood products, which were labeled with an incorrect volume, was distributed.",9/26/2012,"09/26/2012",1/30/2013,"01/30/2013"
"Biologics",63645,"Terminated","American National Red Cross (The)","Pomona","CA","US","Voluntary: Firm Initiated","Letter","CA","B-0087-14","Class II","Red Blood Cells Leukocytes Reduced","06FE46787, 06GF94083, 06GG21093, 06GL18878, 06GQ85696, 06GV96048, 06LQ17871, 06FC75130, 06GC87474, 06GH46640, 06GL20950, 06LW15617, 06GX02769, 06GQ88411, 06FC75119, 06GF01602, 06FR20160, 06FR20163, 06GC88963, 06GE52114, 06GK63347, 06GK63399, 06GQ89307, 06GW71782, 06GW71965, ",".","25 units","Blood products, collected from a donor who traveled to an area considered endemic for malaria, were distributed. ",8/10/2012,"08/10/2012",12/4/2013,"12/04/2013"
"Biologics",63645,"Terminated","American National Red Cross (The)","Pomona","CA","US","Voluntary: Firm Initiated","Letter","CA","B-0088-14","Class II","Red Blood Cells (Apheresis) Leukocytes Reduced","06GE48899, 06GS58424, 06GF02674, 06GC85007",".","4 units","Blood products, collected from a donor who traveled to an area considered endemic for malaria, were distributed. ",8/10/2012,"08/10/2012",12/4/2013,"12/04/2013"
"Biologics",63645,"Terminated","American National Red Cross (The)","Pomona","CA","US","Voluntary: Firm Initiated","Letter","CA","B-0086-14","Class II","Red Blood Cells Leukocytes Reduced Irradiated","06GC87581, 06LX14390",".","2 units","Blood products, collected from a donor who traveled to an area considered endemic for malaria, were distributed. ",8/10/2012,"08/10/2012",12/4/2013,"12/04/2013"
"Devices",63651,"Ongoing","Winco Mfg., LLC","Ocala","FL","US","Voluntary: Firm Initiated","Telephone","Nationwide Distribution including CA, FL, IL, MA, MD, MN, NM, NY, OH, OK, and TX.","Z-0777-2013","Class II","PREMIER LIFECARE RECLINER 5400 WITH CAL TB 133 UPGRADE PURCHASED JAN 01, 2011 TO AUGUST 20, 2012. A multi position recliner with a steel frame used primarily in clinics, hospitals, and treatment centers for recovery, dialysis, oncology, examination, infusion.","Model 5400. Serial numbers: 540100017, 540100020, 540100063, 540100160, 540100161, 540100162, 540100062, 540100103, 540100104, 540100105, and 540100106.",,"95 units (all models)","The performance of the chemicals in the foam and vinyl are not consistent enough to meet the TB 133 fire protection mandate required by California and 4 other states.",9/24/2012,"09/24/2012",2/13/2013,"02/13/2013"
"Devices",63651,"Ongoing","Winco Mfg., LLC","Ocala","FL","US","Voluntary: Firm Initiated","Telephone","Nationwide Distribution including CA, FL, IL, MA, MD, MN, NM, NY, OH, OK, and TX.","Z-0780-2013","Class II","Designer Care Cliner 6700/6704/6710 WITH CAL TB 133 UPGRADE PURCHASED JAN 01, 2011 TO AUGUST 20, 2012. A multi position recliner with a steel frame used primarily in clinics, hospitals, and treatment centers for recovery, dialysis, oncology, examination, infusion.","Model 6700, 6704 and 6710. Serial numbers: 670A100027, 670A100028, 670A100323, 670100082, 670100083, 670A100101, 670A100021, 670A100324, 670A100325, 670A100284, 670A100242, 670100005, 670100124, 670100125, 670100181, 670100182, 670100183, 670100184, 670100185, 670100186, 670100026, 670A100004, 670A100036, 670A100037, 670A100038, 670A100039, 670A100040, 670A100041, 670A100042, 670A100043, 670A100044, 670A100124, 670A100135, 670A100138, 670A100137, 670A100278, 670A100299, 670A100308, 670A100345, 670A100365, 670A100191, 670A100243, 670A100303, 670100027, 670100193, 670A100244, 670A100245, 670A100246, 670100018, 670100022, 670100021, 670100020, 670100175, 670100176, 670100177, 670100171, 670100187, 670100188, 670100189, and 670100190",,"95 units (All models)","The performance of the chemicals in the foam and vinyl are not consistent enough to meet the TB 133 fire protection mandate required by California and 4 other states.",9/24/2012,"09/24/2012",2/13/2013,"02/13/2013"
"Devices",63651,"Ongoing","Winco Mfg., LLC","Ocala","FL","US","Voluntary: Firm Initiated","Telephone","Nationwide Distribution including CA, FL, IL, MA, MD, MN, NM, NY, OH, OK, and TX.","Z-0778-2013","Class II","PREMIER CARE RECLINER 5570/5574 WITH CAL TB 133 UPGRADE PURCHASED JAN 01, 2011 TO AUGUST 20, 2012. A multi position recliner with a steel frame used primarily in clinics, hospitals, and treatment centers for recovery, dialysis, oncology, examination, infusion.","Model 5570 and 5574. Serial numbers: 557A100080, 557A100081, 557100004, 557100008, 557100009, 557100012, 557100041, 557100042, 557100043, 557100044, 557100045, 557A100065, 557100036, 557100037, 557100038, 557100039, 557A100073, and 557100048.",,"95 units (All models)","The performance of the chemicals in the foam and vinyl are not consistent enough to meet the TB 133 fire protection mandate required by California and 4 other states.",9/24/2012,"09/24/2012",2/13/2013,"02/13/2013"
"Devices",63651,"Ongoing","Winco Mfg., LLC","Ocala","FL","US","Voluntary: Firm Initiated","Telephone","Nationwide Distribution including CA, FL, IL, MA, MD, MN, NM, NY, OH, OK, and TX.","Z-0779-2013","Class II","Cozy Comfort Premier Recliner 5580 WITH CAL TB 133 UPGRADE PURCHASED JAN 01, 2011 TO AUGUST 20, 2012. A multi position recliner with a steel frame used primarily in clinics, hospitals, and treatment centers for recovery, dialysis, oncology, examination, infusion.","Model 5580. Serial numbers: 558A100057, 558100022, 558100023, 558100024, 558100025, 558100026, and 558A100075.",,"95 units (All models)","The performance of the chemicals in the foam and vinyl are not consistent enough to meet the TB 133 fire protection mandate required by California and 4 other states.",9/24/2012,"09/24/2012",2/13/2013,"02/13/2013"
"Devices",63654,"Ongoing","GE Healthcare, LLC","Waukesha","WI","US","Voluntary: Firm Initiated","Letter","Nationwide Distribution - ALL STATES IN CONTINENTAL USA INCLUDING PR and DC excluding AK, DE, ND, and VT. ALGERIA, AUSTRALIA, ANGOLA, ARGENTINA, AUSTRIA, BAHAMAS, BAHRAIN, BANGLADESH, BELGIUM, BOSNIA HERZEGOVINA, BRAZIL, BRUNEI, BULGARIA, CAMBODIA, CANADA, CHILE, CHINA, COLOMBIA, COSTA RICA, CROATIA, CUBA, CYPRUS, CZECH REPUBLIC, DENMARK, ECUADOR, EGYPT, EL SALVADOR, ESTONIA, FINLAND, FRANCE, GEORGIA, GERMANY, GHANA, GREECE, GUATEMALA, HONDURAS, HONG KONG, HUNG ARIA, ICELAND, INDIA, INDONESIA, IRAQ, IRELAND, ISRAEL, ITALY, JAPAN, JORDAN, KAZAHSTAN, KENYA, KOREA, KUWAIT, LATIVIA, LEBANON, LIBYA, LITHUANIA, MACEDONIA, MALAYSIA, MEXICO, MALTA, MOROCCO, NEPAL, NETHERLAND, NEW ZEALAND, NIGERIA, NORWAY, PAKISTAN, PALESTINIAN, PANAMA, PARAGUAY, PERU, PHILIPPINES, POLAND, PORTUGAL, QATAR, ROMANIA, RUSSIA, SAUDI ARABIA, SINGAPORE, SLOVENIA, SOUTH AFRICA, SPAIN, SRI LANKA, SWEDEN, SWITZERLAND, SYRIA, TAIWAN THAILAND, TRINIDAD AND TOBAGO,K TUNISIA, TURKEY, UGANDA, UKRAINE, UNITED ARB EMIRATES , UNITED KINGDOM, URUGUAY. PUERTO RICO","Z-0813-2013","Class II","GE Healthcare, Dash 3000, Dash 4000 and Dash 5000 Physiological Patient Monitor and accessories.","FMI# & Descr: 36080 DASH 3/4/5k Custom Auto NBP System ID (As required) SD010210331GA SD010262074GA SD010262088GA SD010272286GA SD010272290GA SD010272298GA SD010272299GA SD010272300GA SD010272304GA SD010272306GA SD010272307GA SD010272308GA SD010272518GA SD010272529GA SD010272531GA SD010272533GA SD010272535GA SD010272536GA SD010272537GA SD010272539GA SD010272541GA SD010272542GA SD010272544GA SD010272545GA SD010272546GA SD010272547GA SD010292708GA SD010292709GA SD010292711GA SD010292836GA SD010292904GA SD010292966GA SD010292968GA SD010292969GA SD010292977GA SD010292978GA SD010292980GA SD010292982GA SD010292984GA SD010292985GA SD010292986GA SD010292987GA SD010292988GA SD010292989GA SD010292990GA SD010292991GA SD010292992GA SD010292993GA SD010292994GA SD010292995GA SD010292996GA SD010292997GA SD010292999GA SD010293000GA SD010293106GA SD010293107GA SD010293108GA SD010293109GA SD010293110GA SD010293113GA SD010293114GA SD010293115GA SD010293116GA SD010293118GA SD010293119GA SD010293120GA SD010293121GA SD010293122GA SD010293123GA SD010293124GA SD010293125GA SD010293126GA SD010293127GA SD010293128GA SD010293129GA SD010293131GA SD010293132GA SD010293133GA SD010293134GA SD010293135GA SD010293136GA SD010293139GA SD010293141GA SD010293142GA SD010293143GA SD010293144GA SD010293145GA SD010293146GA SD010293147GA SD010293148GA SD010303149GA SD010303150GA SD010303152GA SD010303153GA SD010303155GA SD010303156GA SD010303157GA SD010303158GA SD010303159GA SD010303160GA SD010303161GA SD010303162GA SD010303163GA SD010303164GA SD010303165GA SD010303167GA SD010303168GA SD010303169GA SD010303170GA SD010303171GA SD010303172GA SD010303173GA SD010303174GA SD010303175GA SD010303176GA SD010303177GA SD010303178GA SD010303179GA SD010303180GA SD010303181GA SD010303182GA SD010303183GA SD010303184GA SD010303185GA SD010303186GA SD010303188GA SD010303189GA SD010303190GA SD010303191GA SD010303192GA SD010303193GA SD010303194GA SD010303195GA SD010303196GA SD010303290GA SD010303291GA SD010303292GA SD010303293GA SD010303294GA SD010303295GA SD010303296GA"," SD008219894GA SD008283751GA SD008283818GA SD008356585GA SD008356720GA SD008377622GA SD008377741GA SD008377804GA SD008377805GA SD008377806GA SD008377807GA SD008377808GA SD008377809GA SD008377810GA SD008377811GA SD008377812GA SD008377813GA SD008377853GA SD008377855GA SD008377856GA SD008377859GA SD008377860GA SD008377861GA SD008377929GA SD008377930GA SD008377933GA SD008421279GA SD008441859GA SD008441868GA SD009016759GA SD009016762GA SD009016765GA SD009027095GA SD009047597GA SD009234025GA SD009234026GA SD009234027GA SD009234029GA SD009234033GA SD009234095GA SD009234104GA SD009244444GA SD009244510GA SD009244565GA SD009244619GA SD009244621GA SD009244623GA SD009244706GA SD009255107GA SD009265411GA SD009296225GA SD009316953GA SD009327171GA SD009327173GA SD009327179GA SD009327231GA SD009327427GA SD009327429GA SD009327430GA SD009337710GA SD009337715GA SD009430918GA SD009431086GA SD009441315GA SD009451432GA SD009451439GA SD009451587GA SD009451589GA SD009451591GA SD009451592GA SD009451594GA SD009451598GA SD009451599GA SD009472067GA SD009482566GA SD009482570GA SD009482571GA SD010106208GA SD010116796GA SD010116797GA SD010189734GA SD010210342GA SD010210343GA SD010376834GA SD010418668GA SD010502134GA SD010522612GA SD010522613GA SD010522616GA SD010522632GA SD011050918SA SD011050919SA SD011051049SA SD011051060SA SD011071560SA SD011071836SA SD011071840SA SD011071895SA SD011071914SA SD011071987SA SD011072145SA SD011082383SA SD011112772SA SD011112789SA SD011143749SA SHQ11280637SA SHQ11280638SA SHQ11280643SA SHQ11280665SA SHQ11311383SA SHQ12096428SA SHQ12096442SA SHQ12096459SA SHQ12106543SA SHQ12106546SA SHQ12116571SA SHQ12116584SA SHQ12116634SA SHQ12126719SA SHQ12126721SA SHQ12126724SA SHQ12126725SA SHQ12126726SA SHQ12126727SA SHQ12126728SA SHQ12126729SA SHQ12126730SA SHQ12167162SA SHQ12187475SA SHQ12187476SA SHQ12187478SA SHQ12187479SA SHQ12187480SA SHQ12238288SA SHQ12238291SA SD008168779GA SD008168781GA SD008168782GA SD008168783GA SD008252879GA SD008294273GA SD008367245GA SD008377570GA SD008377571GA SD009047791GA SD009047793GA ","119,262","GE has become aware of multiple issues affecting the Dash 3000/4000/5000 Patient Monitor. These issues may occur when the Ethernet controller in the XPC823 CPU on the Dash and DashPort 2 motherboard functions intermittently. GE Healthcare has identified that these issues occur most often at sites with large Unity Network installations. It should be noted that the Dash 3000/4000/5000 patient monitor continues to monitor parameters and alarms as a stand-alone bedside with no issues.",6/13/2012,"06/13/2012",2/20/2013,"02/20/2013"
"Drugs",63656,"Ongoing","F. Hoffmann-LaRoche Ltd.","Basel",,"CH","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","No product distributed in the USA. Bulk product distributed to Switzerland, with further distribution in Europe, Scandinavia, Korea.","D-105-2013","Class II","Cymevene 500 mg Powder for Infusion, (ganciclovir), 50 mg/mL ganciclovir (reconstructed), Rx only, 10 mL vials, Roche Products Limited, Welwyn Garden City, AL7 1TW, United Kingdom","bulk lot N0019, Expiration Date: 11 2014 Warennummer: 10131968 Chargennummer:NXXXX 2000609D Finished product Lot N0019B01-N0019B12 ",".","42010 vials","Lack of Assurance of Sterility; container closure issues with the bulk batch. ",9/5/2012,"09/05/2012",1/2/2013,"01/02/2013"
"Food",63657,"Ongoing","Fresh Express Incorporated","Salinas","CA","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","AZ, CA, CO, HI, ID, KS, MO, MT, NE, NV, NM, OK, OR, SD, TX, UT, WA and WY.","F-0859-2013","Class I","Fresh Express brand, Fresh Spinach, 9 oz.","Lot #S299B25",".","6610 units","Product tested positive for Salmonella",11/7/2012,"11/07/2012",1/9/2013,"01/09/2013"
"Food",63658,"Ongoing","Spence & Co., Ltd.","Brockton","MA","US","Voluntary: Firm Initiated","Telephone","FL,NC, GA ,NJ, NY ,VA, OH, NV,OK,KY, TN, CO, IL, MA ,MO, RI,VT, NH ,ME, SC, IN, MI","F-0853-2013","Class I","Spence & Co New York-Style Nova Lox 4oz , refrigerated Spence & Co Smoked Salmon Trimmings, 2lb bulk (bag)","Code: 9720704 ",".","1563 units (4 oz) ; 25 (2Lb)","Product contaminated with Listeria monocytogenes",11/8/2012,"11/08/2012",1/2/2013,"01/02/2013"
"Devices",63662,"Ongoing","GE Healthcare, LLC","Waukesha","WI","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution and US (nationwide) including DC and the countries of ALGERIA, ARAB EMIRATES, AUSTRALIA, AUSTRIA, BANGLADESH, BELGIUM, BRAZIL, CANADA, CHINA, CYPRUS, CZECH REPUBLIC, DENMARK, EGYPT, FRANCE, GERMANY, INDIA, ISRAEL, ITA LY, JAPAN, JORDAN, KUWAIT, MOROCCO, NETHERLANDS, NEW ZEALAND, NORWAY, POLAND, PORTUGAL, RUSSIA, SAUDI ARABIA, SINGAPORE SLOVENIA, SOUTH KOREA, SPAIN SWEDEN SWITZERLAND, TAIWAN, TURKEY, UNITED KINGDOM.","Z-0814-2013","Class II","GE Healthcare, Dash Port 2 Docking Station. Product Usage: is a docking station (quick mount/dismount base) for a Dash patient monitor. The system is to monitor physiologic parameter data on adult, pediatric, and neonatal patients. ","Mfg Lot or Serial # SE507460028GA SE507460050GA SE507460053GA SE507460054GA SE507460055GA SE507460056GA SE507460057GA SE507460058GA SE507460059GA SE507460060GA SE507460061GA SE507460062GA SE507460063GA SE507460066GA SE507460067GA SE507480070GA SE507480071GA SE507480073GA SE507480075GA SE507480077GA SE507480078GA SE507480079GA SE507480080GA SE507480082GA SE507480083GA SE507480084GA SE507480085GA SE507480091GA SE507480098GA SE507480099GA SE507480101GA SE507480102GA SE507480105GA SE507480108GA SE507480109GA SE507480110GA SE507480115GA SE507480118GA SE507480120GA SE507480123GA SE507480124GA SE507480125GA SE507480135GA SE507480139GA SE507480148GA SE507480163GA SE507480168GA SE507480178GA SE507480185GA SE507480191GA SE507480192GA SE507480196GA SE507480197GA SE507480198GA SE507480201GA SE507480213GA SE507480217GA SE507480222GA SE507480225GA SE507480226GA SE507480230GA SE507480233GA SE507480234GA SE507480237GA SE507480245GA SE507480246GA SE507480247GA SE507480248GA SE507480250GA SE507480251GA SE507480256GA SE507480257GA SE507480258GA SE507480259GA SE507480260GA SE507480264GA SE507480268GA SE507480269GA SE507480274GA SE507480282GA SE507480289GA SE507480294GA SE507490301GA SE507490306GA SE507490308GA SE507490310GA SE507490312GA SE507490313GA SE507490314GA SE507490317GA SE507490319GA SE507490322GA SE507490323GA SE507490324GA SE507490326GA SE507490329GA SE507490331GA SE507490334GA SE507490337GA SE507490340GA SE507490341GA SE507490342GA SE507490343GA SE507490345GA SE507490385GA SE507490386GA SE507490387GA SE507490388GA SE507490389GA SE507490390GA SE507490391GA SE507490392GA SE507490393GA SE507490394GA SE507490395GA SE507490396GA SE507490397GA SE507490398GA SE507490399GA SE507490400GA SE507490401GA SE507490402GA SE507490403GA SE507490404GA SE507490405GA SE507490406GA SE507490407GA SE507490414GA SE507490419GA SE507490420GA SE507490421GA SE507490422GA SE507490423GA SE507490425GA SE507490432GA SE507490433GA SE507490435GA SE507490437GA SE507490439GA SE507490440GA SE507490446GA SE507490450GA SE507490451GA SE507490452GA SE5074904"," SE509013273GA SE509013274GA SE509013275GA SE509013276GA SE509013277GA SE509013278GA SE509013279GA SE509013280GA SE509013281GA SE509013282GA SE509013283GA SE509013284GA SE509013285GA SE509013286GA SE509013287GA SE509013288GA SE509013289GA SE509013290GA SE509013291GA SE509013292GA SE509013293GA SE509023294GA SE509023295GA SE509023296GA SE509023297GA SE509023298GA SE509023299GA SE509023300GA SE509023301GA SE509023302GA SE509023303GA SE509023304GA SE509023305GA SE509023306GA SE509023307GA SE509023308GA SE509023309GA SE509023310GA SE509023311GA SE509023312GA SE509023313GA SE509023314GA SE509023315GA SE509023316GA SE509023317GA SE509023318GA SE509023319GA SE509023320GA SE509023321GA SE509023322GA SE509023323GA SE509023324GA SE509023325GA SE509023326GA SE509023327GA SE509023328GA SE509023329GA SE509023330GA SE509023331GA SE509023332GA SE509023333GA SE509023334GA SE509023335GA SE509023336GA SE509023337GA SE509023338GA SE509023339GA SE509023340GA SE509023341GA SE509023342GA SE509023343GA SE509023344GA SE509023345GA SE509023346GA SE509023347GA SE509033348GA SE509033349GA SE509033350GA SE509033351GA SE509033352GA SE509033353GA SE509033354GA SE509033355GA SE509033356GA SE509033357GA SE509033358GA SE509033359GA SE509033360GA SE509033361GA SE509033362GA SE509033364GA SE509033365GA SE509033366GA SE509033367GA SE509033368GA SE509033372GA SE509033373GA SE509033374GA SE509043408GA SE509043409GA SE509043410GA SE509043411GA SE509043412GA SE509043413GA SE509043416GA SE509043417GA SE509043419GA SE509043420GA SE509043421GA SE509043423GA SE509043424GA SE509043427GA SE509043429GA SE509043430GA SE509043431GA SE509043432GA SE509043433GA SE509043434GA SE509043435GA SE509043436GA SE509043437GA SE509043438GA SE509043439GA SE509043440GA SE509043441GA SE509043442GA SE509043443GA SE509043444GA SE509043445GA SE509043446GA SE509043447GA SE509043448GA SE509043449GA SE509043450GA SE509043451GA SE509043452GA SE509043453GA SE509043454GA SE509043455GA SE509043456GA SE509043457GA SE509043458GA SE509043459GA SE509043460GA SE509043461GA SE509043462GA ","10,497","GE has become aware of multiple issues affecting the Dash 3000/4000/5000 and DashPort 2 monitor. This report of correction encompasses the DashPort 2 device, in which the DashPort 2 stops communicating with the Dash, resulting in Loss of Monitoring at the CIC. The DashPort 2 status LEDs in the back of the unit indicate Unity Network and DashPort 2 to Dash communication has stopped.",6/13/2012,"06/13/2012",2/20/2013,"02/20/2013"
"Devices",63665,"Ongoing","DePuy Spine, Inc.","Raynham","MA","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution - US (nationwide) including the states of: AZ, CA, FL, HI, IL, MD,MI, MO,NC, TN, TX and the country of Australia.","Z-0713-2013","Class II","DePuy Spine VIPER POLY SCREW 5.5 10X100MM Tl Product Code: 1867-15-199 Spinal Implant Component.","All lots ",".","10 units","Polyaxial screws 8x 80 and larger may disassociate when inserting in the Ilium. VIPER large diameter long screws in high-torque circumstances, the screw shank has the potential to separate from the polyaxial head",11/7/2012,"11/07/2012",1/30/2013,"01/30/2013"
"Devices",63665,"Ongoing","DePuy Spine, Inc.","Raynham","MA","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution - US (nationwide) including the states of: AZ, CA, FL, HI, IL, MD,MI, MO,NC, TN, TX and the country of Australia.","Z-0709-2013","Class II","DePuy Spine VIPER POLY SCREW 5.5 9 X 80MM Tl Product Code: 1867-15-980 Spinal Implant Component.","All lots ",".","34 uits","Polyaxial screws 8x 80 and larger may disassociate when inserting in the Ilium., VIPER large diameter long screws in high-torque circumstances, the screw shank has the potential to separate from the polyaxial head",11/7/2012,"11/07/2012",1/30/2013,"01/30/2013"
"Devices",63665,"Ongoing","DePuy Spine, Inc.","Raynham","MA","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution - US (nationwide) including the states of: AZ, CA, FL, HI, IL, MD,MI, MO,NC, TN, TX and the country of Australia.","Z-0705-2013","Class II","DePuy Spine VIPER POLY SCREW 5.5 8 X70MM Tl Product Code: 1867-15-870 Spinal Implant Component.","All lots ",".","34 units","Polyaxial screws 8x 80 and larger may disassociate when inserting in the Ilium., VIPER large diameter long screws in high-torque circumstances, the screw shank has the potential to separate from the polyaxial head",11/7/2012,"11/07/2012",1/30/2013,"01/30/2013"
"Devices",63665,"Ongoing","DePuy Spine, Inc.","Raynham","MA","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution - US (nationwide) including the states of: AZ, CA, FL, HI, IL, MD,MI, MO,NC, TN, TX and the country of Australia.","Z-0707-2013","Class II","DePuy Spine VIPER POLY SCREW 5.5 8 X100MM Tl Product Code: 1867-15-899 Spinal Implant Component.","All lots ",".",,"Polyaxial screws 8x 80 and larger may disassociate when inserting in the Ilium., VIPER large diameter long screws in high-torque circumstances, the screw shank has the potential to separate from the polyaxial head",11/7/2012,"11/07/2012",1/30/2013,"01/30/2013"
"Devices",63665,"Ongoing","DePuy Spine, Inc.","Raynham","MA","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution - US (nationwide) including the states of: AZ, CA, FL, HI, IL, MD,MI, MO,NC, TN, TX and the country of Australia.","Z-0708-2013","Class II","DePuy Spine VIPER POLY SCREW 5.5 9 X70MM Tl Product Code: 1867-15-970 Spinal Implant Component.","All lots ",".","24 units","Polyaxial screws 8x 80 and larger may disassociate when inserting in the Ilium., VIPER large diameter long screws in high-torque circumstances, the screw shank has the potential to separate from the polyaxial head",11/7/2012,"11/07/2012",1/30/2013,"01/30/2013"
"Devices",63665,"Ongoing","DePuy Spine, Inc.","Raynham","MA","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution - US (nationwide) including the states of: AZ, CA, FL, HI, IL, MD,MI, MO,NC, TN, TX and the country of Australia.","Z-0710-2013","Class II","DePuy Spine VIPER POLY SCREW 5.5 9 X100MM Tl Product Code: 1867-15-999 Spinal Implant Component.","All lots ",".","23 units","Polyaxial screws 8x 80 and larger may disassociate when inserting in the Ilium., VIPER large diameter long screws in high-torque circumstances, the screw shank has the potential to separate from the polyaxial head",11/7/2012,"11/07/2012",1/30/2013,"01/30/2013"
"Devices",63665,"Ongoing","DePuy Spine, Inc.","Raynham","MA","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution - US (nationwide) including the states of: AZ, CA, FL, HI, IL, MD,MI, MO,NC, TN, TX and the country of Australia.","Z-0711-2013","Class II","DePuy Spine VIPER POLY SCREW 5.5 10 X 70MM Tl Product Code: 1867-15-170 Spinal Implant Component.","All lots ",".","2 units","Polyaxial screws 8x 8 and larger may disassociate when inserting in the Ilium., VIPER large diameter long screws in high-torque circumstances, the screw shank has the potential to separate from the polyaxial head",11/7/2012,"11/07/2012",1/30/2013,"01/30/2013"
"Devices",63665,"Ongoing","DePuy Spine, Inc.","Raynham","MA","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution - US (nationwide) including the states of: AZ, CA, FL, HI, IL, MD,MI, MO,NC, TN, TX and the country of Australia.","Z-0706-2013","Class II","DePuy Spine VIPER POLY SCREW 5.5 8 X80MM Tl Product Code: 1867-15-880 Spinal Implant Component.","All lots ",".","36 units","Polyaxial screws 8x 80 and larger may disassociate when inserting in the Ilium., VIPER large diameter long screws in high-torque circumstances, the screw shank has the potential to separate from the polyaxial head",11/7/2012,"11/07/2012",1/30/2013,"01/30/2013"
"Devices",63665,"Ongoing","DePuy Spine, Inc.","Raynham","MA","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution - US (nationwide) including the states of: AZ, CA, FL, HI, IL, MD,MI, MO,NC, TN, TX and the country of Australia.","Z-0712-2013","Class II","DePuy Spine VIPER POLY SCREW 5.5 10 X 80MM Tl Product Code: 1867-15-180 Spinal Implant Component.","All lots ",".","6 units","Polyaxial screws 8x 80and larger may disassociate when inserting in the Ilium., VIPER large diameter long screws in high-torque circumstances, the screw shank has the potential to separate from the polyaxial head",11/7/2012,"11/07/2012",1/30/2013,"01/30/2013"
"Biologics",63668,"Terminated","LifeSouth Community Blood Centers, Inc.","Gainesville","FL","US","Voluntary: Firm Initiated","FAX","Alabama","B-0443-13","Class II","Platelets Pheresis Leukocytes Reduced Irradiated","W115112332625J; ",".","1 unit","Blood product, which was labeled as leukoreduced, but was not tested to verify the White Blood Cell count, was distributed.",10/19/2012,"10/19/2012",1/30/2013,"01/30/2013"
"Biologics",63669,"Terminated","Community Blood Bank of Lancaster County Medical Society","Lincoln","NE","US","Voluntary: Firm Initiated","FAX","Tennessee; Nebraska; California; Austria","B-0445-13","Class III","Blood and Blood Products for Reprocessing","W087911314009; W087912302059; W087912305315; W087912605513; ",".","4 units","Blood products, collected from a donor who was at risk for variant Creutzfeldt-Jakob disease (vCJD), were distributed.",9/18/2012,"09/18/2012",1/30/2013,"01/30/2013"
"Biologics",63669,"Terminated","Community Blood Bank of Lancaster County Medical Society","Lincoln","NE","US","Voluntary: Firm Initiated","FAX","Tennessee; Nebraska; California; Austria","B-0444-13","Class II","Red Blood Cells Leukocytes Reduced","W087911314009; W087912302059; W087912305315; W087912605513; ",".","4 units","Blood products, collected from a donor who was at risk for variant Creutzfeldt-Jakob disease (vCJD), were distributed.",9/18/2012,"09/18/2012",1/30/2013,"01/30/2013"
"Biologics",63670,"Terminated","The Blood Connection, Inc.","Piedmont","SC","US","Voluntary: Firm Initiated","Telephone","Massachusetts","B-0449-13","Class II","Red Blood Cells Leukocytes Reduced","W121612164441; ",".","1 unit","Blood product, collected from a donor for whom a hemoglobin screening test was not performed, was distributed.",8/15/2012,"08/15/2012",1/30/2013,"01/30/2013"
"Devices",63671,"Ongoing","Philips Healthcare Inc.","Andover","MA","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution - USA (nationwide) and Internationally to Argentina, Australia, Austria, Canada, Chile, Czech republic, Estonia,France, Germany, Hungary, Inida, Ireland, Italy, Japan, Libyan Arab Jamahari, Mexico, Netherlands, New Zealand, Norway , Oman, Panama, Peru, Poland, Qatar, Reunion, Russia, Saudi Arabia, South Africa, South Korea,Spain, Sweden, Swizerland, Thailand, UAE, and the UK.","Z-0900-2013","Class II","Philips Digital Diagnost Stationary radiographic system","All Digital Diagnost systems with Eleva software version 3.0.x",,"360","When the operator for a wall stand view selects an ''image rotation'' different from default, or such image rotation is preset in the examination database, then the resulting image may be rotated in the wrong direction. When the operator manually rotates the image back, electronic side markers (if programmed) are rotated also and as a result may be placed in a wrong position inside the image.",10/30/2012,"10/30/2012",3/13/2013,"03/13/2013"
"Devices",63674,"Ongoing","Philips Healthcare Inc.","Andover","MA","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution - USA Nationwide and the Foreign countries of: Austria, Canada, Belgium, China,Denmark, France, germany, Italy, Netherlands,New Zealand, Norway, Philippines, Portugual, SOuth Korea, Spain, Switzerland, Thailand, and UK.","Z-0884-2013","Class II","Philips DigitalDiagnost X-Ray System with Eleva Software 2.1.3Model numbers 712020, 712022, and 712082 Product Usage: Digital radiographic system","Systems with Eleva SW version 2.1.3",,"551","When the operator for a wall stand view selects an ''image rotation'' different from default, or such image rotation is preset in the examination database, then the resulting image may be rotated in the wrong direction. When the operator manually rotates the image back, electronic side markers (if programmed) are rotated also and as a result may be placed in a wrong position inside the image.",10/25/2012,"10/25/2012",3/6/2013,"03/06/2013"
"Devices",63676,"Ongoing","Greatbatch Medical","Minneapolis","MN","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution-USA including the states of AL, AK, AZ, ALR, CA, CO, CT, DC, FL, GA, HI, IL IN, IA, KY, MD, MA, MI, MN, MO, NE, NV,NM, NJ, NH, NY, NC, OH, OK OR, PA, RI,SC,SD, TN, TX, UT,VT, VA, WA, and WI, and the countries of AUSTRIA, BELGIUM, SWITZERLAND, GERMANY, DENMARK, SPAIN, FINLAND, FRANCE, UNITED KINGDOM, GREECE, HUNGARY, IRELAND, ISRAEL, ITALY, THE NETHERLAND, NORWAY, SWEDEN, AUSTRALIA, and CANADA","Z-0611-2013","Class II","Biosense Webster MobiCath Bi-Directional Guiding Sheath. Small Curve catalog no. D140010, Large Curve catalog no. D140011. The MobiCath Bi-Directional Guiding Sheath is a flexible tipped percutaneous catheter introducer (or guiding sheath) designed for gaining access to the coronary systems. The device features adjustable tip geometry through use of a rotating handle to deflect the catheter. This catheter is assembled with a hemostasis valve and a sideport infusion line. The MobiCath Bi-Directional Guiding Sheath is intended for introducing various cardiovascular catheters into the heart, including the left side of the heart through the interatrial septum.","LOT: R1701247 , R1713591 , W2046680 , W2046681 , W2072907 , W2078460 , W2084872 , W2098771 , W2102124 , W2102133 , W2102134 , W2108295 , W2108296 , W2108298 , W2108299 , W2125688 , W2125690 , W2132584 , W2132588 , W2132590 , W2138965 , W2143147 , W2143149 , W2143152 , W2145645 , W2145677 , W2145680 , W2145681 , W2151287 , W2151305 , W2151308 , W2156746 , W2156748 , W2156750 , W2156751 , W2162496 , W2162497 , W2162498 , W2162499 , W2167986 , W2167987 , W2167988 , W2167990 , W2172705 , W2172706 , W2172707 , W2172708 , W2172710 , W2172712 , W2177727 , W2177728 , W2177733 , W2177734 , W2184476 , W2184483 , W2184484 , W2184487 , W2190457 , W2190461 , W2190464 , W2190470 , W2196349 , W2196351 , W2196352 , W2196355 , W2196359 , W2196361 , W2196363 , W2211842 , W2211844 , W2211846 , W2211849 , W2211852 , W2211853 , W2213887 , W2229974 , W2236588.",".","10,201 units","Greatbatch Medical observed some anomalies of the inner lumen of the MobiCath Bi-Directional Guiding Sheaths upon implementation of a new visual inspection tool. The anomalies may include loose, string-like liner material, liner abrasion (fraying), and/or attached string-like liner material (from scratches or damage on the inner wall of sheath lumen).",11/12/2012,"11/12/2012",1/2/2013,"01/02/2013"
"Food",63677,"Ongoing","Frito Lay, Inc","Plano","TX","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Nationwide","F-0877-2013","Class I","Grandma's Peanut Butter Sandwich Creme Cookies, Net WT. 3.025 oz, Frito-Lay, Inc. Plano, TX 75024","GRANDMA'S Peanut Butter Sandwich Creme cookies have a sell-by date of March 12, 2013 or earlier and UPC code of 28400-00153.",".","12,000 cases (720,000 units) of the 3.025 oz & 3,378 cases (202,000 units) of the 1.71 oz","The firm is recalling GRANDMA'S Peanut Butter Sandwich Creme cookies and GRANDMA'S Peanut Butter Mini Sandwich Creme cookies because they contain undeclared milk and egg.",11/9/2012,"11/09/2012",1/23/2013,"01/23/2013"
"Food",63677,"Ongoing","Frito Lay, Inc","Plano","TX","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Nationwide","F-0878-2013","Class I","Grandma's Peanut Butter Mini Sandwich Creme Cookies, Net WT. 1.71 oz, Frito-Lay, Inc. Plano, TX 75024","GRANDMA'S Peanut Butter Mini Sandwich Creme cookies have a sell-by date of May 21, 2013 or earlier and UPC code of 28400-00901. The sell-by date is located on the front of the package.",".",,"The firm is recalling GRANDMA'S Peanut Butter Sandwich Creme cookies and GRANDMA'S Peanut Butter Mini Sandwich Creme cookies because they contain undeclared milk and egg.",11/9/2012,"11/09/2012",1/23/2013,"01/23/2013"
"Biologics",63679,"Terminated","Central Jersey Blood Center, Inc.","Eatontown","NJ","US","Voluntary: Firm Initiated","Telephone","New Jersey","B-0450-13","Class II","Red Blood Cells Leukocytes Reduced Irradiated","W053512014914; ",".","1 unit","Blood product, mislabeled as to antigen phenotype, was distributed.",9/2/2012,"09/02/2012",1/30/2013,"01/30/2013"
"Devices",63683,"Ongoing","Zimmer, Inc.","Warsaw","IN","US","Voluntary: Firm Initiated","Letter","Worldwide distribution: USA (nationwide) including states of: AR, AZ, CA, CO, CT, DC, FL, GA, ID, LA, MD, MI, MN, MO, NC, NV, NY, OH, OK, PA, TN, TX, WI, and WV; and countries of: Australia, El Salvador, France and Singapore.","Z-0594-2013","Class I","Ardis Interbody System Inserter The Ardis Inserter is intended for delivery of the Ardis Implant into the cleared disc space. The implant is secured to the inserter via finger-tightening the gold and silver knobs of the inserter to thread the shaft securely to the implant. Once the implant is inserted into the disc space and its position confirmed radiographically, the inserter is removed from the implant by turning the knobs counterclockwise to loosen and unthread the shaft from the implant.","Ardis Inserter, Part number: 3256-01 Lot numbers - 52ZW, 50CL, 53BB, 55AB, 580S, 580T, 60JY, 60JZ, 62KP, 63HJ, 64EY, 68AX, 71JE, and 75LE",".","315","The Ardis System implant may break when excessive lateral forces are applied to the implant during insertion using the Ardis Inserter. Zimmer Spine has received complaint reports at a 0.47% occurrence rate associated with this issue (data from a 54 month monitoring period).",11/12/2012,"11/12/2012",1/2/2013,"01/02/2013"
"Drugs",63684,"Ongoing","The Menz Club, LLC","Ridgeland","MS","US","Voluntary: Firm Initiated","E-Mail","Utah","D-266-2013","Class I","Blue Male Enhancement Pill, bulk product, by The Menz Club, Ridgeland, MS","None",".","50,000 capsules","Marketed without an Approved NDA/ANDA; product found to contain sulfoaildenafil, an analogue of sildenafil, the active ingredient in a FDA approved product used for erectile dysfunction, making it an unapproved new drug",3/10/2012,"03/10/2012",4/24/2013,"04/24/2013"
"Veterinary",63686,"Terminated","Magnolia Bird Farm Inc","Anaheim","CA","US","Voluntary: Firm Initiated","Telephone","California and Nevada","V-133-2013","Class I","Magnolia Bird Farm Large Hookbill, 2 lbs. clear plastic; 5 lbs.; 10 lbs. in brown Kraft bag; 25 lbs; 50 lbs. in white paper bag;***PACKAGED BY MAGNOLIA BIRD FARM 8990 CERRITOS AVE. ANAHEIM, CA. 92804***12200 MAGNOLIA AVE. RIVERSIDE, CA. 92503","No identifying codes are used by the firm for these products.",".","52,428 lbs total all products recalled.","Magnolia Bird Farm is recalling Bird Feed Mix that contains In-Shell Peanuts from Sunland Inc. because it may be contaminated with Salmonella.",10/24/2012,"10/24/2012",1/30/2013,"01/30/2013"
"Veterinary",63686,"Terminated","Magnolia Bird Farm Inc","Anaheim","CA","US","Voluntary: Firm Initiated","Telephone","California and Nevada","V-129-2013","Class I","Magnolia Bird Farm Hookbill Supreme, 2 lbs. clear plastic; 5 lbs.; 10 lbs. in brown Kraft bag; 25; 50 lbs. in white paper bag;***PACKAGED BY MAGNOLIA BIRD FARM 8990 CERRITOS AVE. ANAHEIM, CA. 92804***12200 MAGNOLIA AVE. RIVERSIDE, CA. 92503.","No identifying codes are used by the firm for these products",".","52,428 lbs total all products recalled.","Magnolia Bird Farm is recalling Bird Feed Mix that contains In-Shell Peanuts from Sunland Inc. because it may be contaminated with Salmonella.",10/24/2012,"10/24/2012",1/30/2013,"01/30/2013"
"Veterinary",63686,"Terminated","Magnolia Bird Farm Inc","Anaheim","CA","US","Voluntary: Firm Initiated","Telephone","California and Nevada","V-132-2013","Class I","Magnolia Bird Farm Hulled Peanuts, 2 lbs. clear plastic. in ***PACKAGED BY MAGNOLIA BIRD FARM 8990 CERRITOS AVE. ANAHEIM, CA. 92804***12200 MAGNOLIA AVE. RIVERSIDE, CA. 92503.","Peanuts packaged in clear plastic bags, brown Kraft bags, or white paper bags have no identifying codes. Peanuts in the original Sunland yellow mesh bag will have either best by dates from October 12, 2012 through October 12, 2013 on the packaging, or a Crop Year marking on the package of 2011 or 2012, up to and including October 12, 2012.",".","52,428 lbs total all products recalled.","Magnolia Bird Farm is recalling Hulled Peanuts from Sunland Inc. because it may be contaminated with Salmonella.",10/24/2012,"10/24/2012",1/30/2013,"01/30/2013"
"Veterinary",63686,"Terminated","Magnolia Bird Farm Inc","Anaheim","CA","US","Voluntary: Firm Initiated","Telephone","California and Nevada","V-130-2013","Class I","Magnolia Bird Farm Conure Mix, 2 lbs. clear plastic; 5 lbs.; 10 lbs. in brown Kraft bag; 25 lbs; 50 lbs. in white paper bag;***PACKAGED BY MAGNOLIA BIRD FARM 8990 CERRITOS AVE. ANAHEIM, CA. 92804***12200 MAGNOLIA AVE. RIVERSIDE, CA. 92503","No identifying codes are used by the firm for these products",".","52,428 lbs total all products recalled.","Magnolia Bird Farm is recalling Bird Feed Mix that contains In-Shell Peanuts from Sunland Inc. because it may be contaminated with Salmonella.",10/24/2012,"10/24/2012",1/30/2013,"01/30/2013"
"Veterinary",63686,"Terminated","Magnolia Bird Farm Inc","Anaheim","CA","US","Voluntary: Firm Initiated","Telephone","California and Nevada","V-131-2013","Class I","Magnolia Bird Farm Parrot Mix, 3 lbs. clear plastic; 5 lbs; 10 lbs. in brown Kraft bag; 25 lbs; 50 lbs. in white paper bag.;***PACKAGED BY MAGNOLIA BIRD FARM 8990 CERRITOS AVE. ANAHEIM, CA. 92804***12200 MAGNOLIA AVE. RIVERSIDE, CA. 92503","No identifying codes are used by the firm for these products",".","52,428 lbs total all products recalled.","Magnolia Bird Farm is recalling Bird Feed Mix that contains In-Shell Peanuts from Sunland Inc. because it may be contaminated with Salmonella.",10/24/2012,"10/24/2012",1/30/2013,"01/30/2013"
"Biologics",63687,"Terminated","Suncoast Communities Blood Bank, Inc.","Sarasota","FL","US","Voluntary: Firm Initiated","E-Mail","Florida","B-0451-13","Class II","Red Blood Cells Leukocytes Reduced","W038612359432; ",".","1 unit","Blood product, which was collected from a donor who traveled to a malarial endemic area, was distributed.",10/17/2012,"10/17/2012",1/30/2013,"01/30/2013"
"Biologics",63688,"Terminated","LifeShare Blood Centers","Monroe","LA","US","Voluntary: Firm Initiated","Telephone","Switzerland","B-0482-13","Class III","Blood and Blood Products for Reprocessing","W036512022332; ",,"1 unit","Blood product, which was collected from an unsuitable donor based on risk factors for variant Creutzfeldt-Jakob Disease (vCJD), was distributed.",9/26/2012,"09/26/2012",2/13/2013,"02/13/2013"
"Biologics",63689,"Terminated","LifeShare Blood Centers","Texarkana","TX","US","Voluntary: Firm Initiated","Telephone","Texas","B-0452-13","Class III","Red Blood Cells Leukocytes Reduced","W036512098530; ",".","1 unit","Blood product, collected from a donor for whom there was no documentation on the donor record of an arm inspection, was distributed.",9/19/2012,"09/19/2012",1/30/2013,"01/30/2013"
"Devices",63692,"Ongoing","Stryker Sustainability Solutions","Tempe","AZ","US","Voluntary: Firm Initiated","Letter","Distributed in Arizona and New Jersey.","Z-0840-2013","Class II","Stryker Sustainability Solutions, AC Power Adaptor for Restep Deep Vein Thrombosis (DVT) System, an external compression system. PUMPKIT (Pump Kit), and RSP159-01 - AC Power Adaptor.","108851407, 108851408, 108870192, 108874144, 108883271, 108886340, and 108888023.",".","1,311","Reports that the AC Power Adaptor may not operate due to wires coming loose in the unit.",8/30/2012,"08/30/2012",2/27/2013,"02/27/2013"
"Biologics",63695,"Terminated","American Red Cross Blood Svs. Indiana-Ohio Region","Fort Wayne","IN","US","Voluntary: Firm Initiated","FAX","Michigan; Ohio; Indiana","B-0453-13","Class II","Platelets Pheresis Leukocytes Reduced Irradiated","038GP54798; ",".","1 unit","Blood products, collected using a machine for which the monthly quality control testing for platelet products failed, were distributed.",8/28/2012,"08/28/2012",1/30/2013,"01/30/2013"
"Biologics",63695,"Terminated","American Red Cross Blood Svs. Indiana-Ohio Region","Fort Wayne","IN","US","Voluntary: Firm Initiated","FAX","Michigan; Ohio; Indiana","B-0454-13","Class II","Platelets Pheresis Leukocytes Reduced","038GP54750; 038GP54750; 038GP54756; 038GP54756; 038GP54772; 038GP54772; 038GP54775; 038GP54775; 038GP54779; 038GP54779; 038GP54779; 038GP54824; 038GP54824; 038GP54824; ",".","14 units","Blood products, collected using a machine for which the monthly quality control testing for platelet products failed, were distributed.",8/28/2012,"08/28/2012",1/30/2013,"01/30/2013"
"Food",63697,"Completed","Golub Corp","Schenectady","NY","US","Voluntary: Firm Initiated","Press Release","Worcester, MA","F-0852-2013","Class I","CMC Pumpkin Coffee Cake 16 oz UPC: 041735225726 Price Chopper/Box","UPC # 41735-225726 expiration date between October 17 and October 25, 2012",".","9 cakes","CMC Cinnamon Coffee Cake was incorrectly labeled as Pumpkin Coffee Cake and therefore did not list walnuts as an ingredient",10/21/2012,"10/21/2012",1/2/2013,"01/02/2013"
"Devices",63698,"Ongoing","Bausch and Lomb, Incorporated","Aliso Viejo","CA","US","Voluntary: Firm Initiated","E-Mail","Worldwide distribution: USA including DC and PR; and countries of: Canada and Mexico accounts not available at this time.","Z-0672-2013","Class I","Bausch and Lomb 27G sterile cannula packed in the Bausch and Lomb Amvisc 1.2% Sodium Hyaluronate ( Model 59051, 59081, 59051L, 59081L) and Amvisc Plus 1.6% Sodium Hyaluronate (Model 60081, 60051, 60051L, 60081L) ophthalmic viscosurgical device. The 27G disposable cannula is attached to the syringe standard luer fitting to deliver the Amvis or Amvis Plus during use as a surgical aid in opthalmic anterior or posterior segment procedures.","B100003G B100015A B100015D B100023A B100023B B100023C B100023D B100023E B100039D B100039F B100046A B100046B B100046C B100058A B100069A B110027D B110028C B110048A B110048D B110056A B120011D B120016A D100008B D100009A D100011A D100011B D100011C D100016B D100016C D100022A D100022B D100022C D100022D D100026A D100026C D100026D D100026E D100030A D100030B D100030C D100035A D100035C D100035D D100043A D100043B D100043C D100044B D100044C D100044D D100044E D100045A D100045B D100045C D100059A D100059B D100059C D100060A D100060B D100061A D100061B D100080A D100081A D100081AS D110015A D110015B D110016A D110045A D110046A D110047A D110070A D110071A D110072A D110090A D110090B D110091A D110092A D110108A D110108B D110108BR D120015A D120015B D120027A D120028A D120029A D120029B D120038B D120039A D120068A D120068B 023632 023633 023639 023640 023647 023801 023811 023863 023886 023897 023920 023933 023972 024022 024025 024028 024257 024323 024436 C10003B E090105A D090095B D090096A D090096C D090097C D090097D Amvisc 1.2% Sodium Hyaluronate ( Model 59051, 59081, 59051L, 59081L) Amvisc Plus 1.6% Sodium Hyaluronate (Model 60081, 60051, 60051L, 60081L)",".","2,342,294","Some disposable cannulas (with 4-digit lot numbers) provided with the Amvisc or Amvisc Plus OVD are not properly engaging to the Luer-Lock on the Amvisc and Amvisc Plus sterile glass syringes. The cannulas may leak viscoelastic material or detach from the syringe during injection. In rare incidents, detachment has resulted in serious patient injury.",11/15/2012,"11/15/2012",1/23/2013,"01/23/2013"
"Food",63700,"Ongoing","Focus Products Group Llc","Lincolnshire","IL","US","Voluntary: Firm Initiated","Press Release","Nationwide","F-0856-2013","Class II","Cocoa~Latte Hot Drink Maker; an electric hot drink mixer and dispenser with a 32 fl.oz. heating and mixing jar, twist and lock lid, ''perfect temperature'' feature, mixing paddle, and dripless faucet; Focus Electrics, LLC, West Bend, WI 53095 ","West Bend brand - model number 65032; Back to Basics brand - model numbers CM300BK, CM300BKL, CM300BLSS, CM300BR, CM300BR-BRL, CM300BRL and CM300W",".","568,000 units","The Cocoa~Latte Hot Drink Maker was manufactured with a small brass metal bushing in the liquid containing vessel that may leach lead.",11/17/2012,"11/17/2012",1/9/2013,"01/09/2013"
"Biologics",63701,"Terminated","American Red Cross Blood Services","Farmington","CT","US","Voluntary: Firm Initiated","FAX","Massachusetts; Connecticut","B-0457-13","Class II","Platelets Pooled Leukocytes Reduced","033GP62198; ",".","1 unit","Blood products, collected from a donor for whom donor suitability was not adequately determined, were distributed.",9/28/2012,"09/28/2012",1/30/2013,"01/30/2013"
"Biologics",63701,"Terminated","American Red Cross Blood Services","Farmington","CT","US","Voluntary: Firm Initiated","FAX","Massachusetts; Connecticut","B-0455-13","Class II","Plasma Frozen","033GP62198; ",".","1 unit","Blood products, collected from a donor for whom donor suitability was not adequately determined, were distributed.",9/28/2012,"09/28/2012",1/30/2013,"01/30/2013"
"Biologics",63701,"Terminated","American Red Cross Blood Services","Farmington","CT","US","Voluntary: Firm Initiated","FAX","Massachusetts; Connecticut","B-0456-13","Class II","Red Blood Cells Leukocytes Reduced","033GP62198; ",".","1 unit","Blood products, collected from a donor for whom donor suitability was not adequately determined, were distributed.",9/28/2012,"09/28/2012",1/30/2013,"01/30/2013"
"Biologics",63702,"Terminated","Knoxville Plasma Corporation","Knoxville","TN","US","Voluntary: Firm Initiated","FAX","California","B-0469-13","Class II","Source Plasma","TQ196210; ",".","1 unit","Blood product, collected from a donor with a history of incarceration, was distributed.",10/26/2012,"10/26/2012",1/30/2013,"01/30/2013"
"Biologics",63704,"Terminated","Inova Health Care Services, Inova Blood Donor Services","Sterling","VA","US","Voluntary: Firm Initiated","Letter","District of Columbia","B-0472-13","Class II","Red Blood Cells Leukocytes Reduced","W089812102768; ",".","1 unit","Blood product, collected from a donor whose health history screening was inadequately performed, was distributed.",10/18/2012,"10/18/2012",1/30/2013,"01/30/2013"
"Biologics",63705,"Terminated","American National Red Cross, Penn-Jersey Region","Philadelphia","PA","US","Voluntary: Firm Initiated","FAX","Pennsylvania","B-0502-13","Class II","Platelets Pheresis Leukocytes Reduced","22KW06774; ",,"1","Blood product, which did not meet the acceptable product specifications, was distributed.",9/13/2012,"09/13/2012",2/13/2013,"02/13/2013"
"Drugs",63706,"Ongoing","Bristol Myers Squibb Manufacturing Company","Humacao","PR","US","Voluntary: Firm Initiated","Telephone","LA, TN, CA","D-181-2013","Class II","ABILIFY (aripiprazole) Tablets, 30 mg, Rx only, Blister Pack of 100 tablets, Otsuka America Pharmaceutical Inc., Bristol-Myers Squibb NDC 59148-011-35","2E69023A, Exp. FEB 28 2015",,"21 blister packs","CGMP Deviations: A drum of Abilify 30 mg Tablets rejected during the compression stage was not segregated from the other portion of the lot and was inadvertently shipped, packaged and distributed.",11/2/2012,"11/02/2012",3/13/2013,"03/13/2013"
"Biologics",63715,"Terminated","Community Blood Centers of Florida, Inc.","Lauderhill","FL","US","Voluntary: Firm Initiated","Letter","New York","B-0503-13","Class II","Red Blood Cells (Apheresis) Leukocytes Reduced","W036809232318A; W036809232318B; ",,"2","Blood products, which were collected from a donor in which donor suitability was not adequately determined, were distributed.",11/4/2012,"11/04/2012",2/13/2013,"02/13/2013"
"Biologics",63716,"Terminated","Community Blood Centers of South Florida, Inc.","Hialeah","FL","US","Voluntary: Firm Initiated","Telephone","Tennessee; Ohio; Florida","B-0507-13","Class II","Fresh Frozen Plasma","W036812401405; W036811297334; ",,"2","Blood products, which were collected from a donor in which donor suitability was not adequately determined, were distributed.",10/23/2012,"10/23/2012",2/13/2013,"02/13/2013"
"Biologics",63716,"Terminated","Community Blood Centers of South Florida, Inc.","Hialeah","FL","US","Voluntary: Firm Initiated","Telephone","Tennessee; Ohio; Florida","B-0505-13","Class II","Red Blood Cells Leukocytes Reduced","W036812401405; ",,"1","Blood products, which were collected from a donor in which donor suitability was not adequately determined, were distributed.",10/23/2012,"10/23/2012",2/13/2013,"02/13/2013"
"Biologics",63716,"Terminated","Community Blood Centers of South Florida, Inc.","Hialeah","FL","US","Voluntary: Firm Initiated","Telephone","Tennessee; Ohio; Florida","B-0506-13","Class II","Platelets Pooled Leukocytes Reduced Irradiated","W036812831776; ",,"1","Blood products, which were collected from a donor in which donor suitability was not adequately determined, were distributed.",10/23/2012,"10/23/2012",2/13/2013,"02/13/2013"
"Biologics",63716,"Terminated","Community Blood Centers of South Florida, Inc.","Hialeah","FL","US","Voluntary: Firm Initiated","Telephone","Tennessee; Ohio; Florida","B-0504-13","Class II","Platelets Pooled Leukocytes Reduced","W036812847654; ",,"1","Blood products, which were collected from a donor in which donor suitability was not adequately determined, were distributed.",10/23/2012,"10/23/2012",2/13/2013,"02/13/2013"
"Biologics",63718,"Terminated","Community Blood Centers of Florida, Inc.","Miami","FL","US","Voluntary: Firm Initiated","Telephone","Florida","B-0508-13","Class II","Plasma Frozen within 24 hours (FP24)","W036812499106; W036812505250; ",,"2","Blood products, which were collected from a donor in which donor suitability was not adequately determined, were distributed.",10/17/2012,"10/17/2012",2/13/2013,"02/13/2013"
"Biologics",63718,"Terminated","Community Blood Centers of Florida, Inc.","Miami","FL","US","Voluntary: Firm Initiated","Telephone","Florida","B-0509-13","Class II","Fresh Frozen Plasma","W036812436897; ",,"1","Blood products, which were collected from a donor in which donor suitability was not adequately determined, were distributed.",10/17/2012,"10/17/2012",2/13/2013,"02/13/2013"
"Devices",63719,"Ongoing","Cooper Vision Caribbean Corp.","Juana Diaz","PR","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","US Nationwide, including Puerto Rico, and Canada.","Z-0631-2013","Class II","AVAIRA (enfilcon A) Soft (Hydrophilic) Daily Wear Toric Contact Lenses ","10447500016006, 10519550007006, 10537500016014",".","246 ","The lenses exceeded the acceptance limit for silicone oil residual.",11/9/2012,"11/09/2012",1/9/2013,"01/09/2013"
"Devices",63729,"Ongoing","Praxair Inc.","Danbury","CT","US","Voluntary: Firm Initiated","Letter","Worldwide distribution: USA (nationwide) and countries of: Brazil, Canada, China, Columbia, Costa Rica, India, Paraguay and Uruguay.","Z-0525-2013","Class I","Praxair Vantage Grab n Go - Gas Cylinder pressure regulator Catalog Number: OX-M-AEGNGVNTG Usage: Regulator reduces pressure in oxygen-containing cylinder.","OX M-AEGNGVNTG (US and Canada) and WESPRX-9500 (Global) Cyclinders in service since Jan 2009. Units with a ''T'' decal (T-teflon) on the fill side of the valve have the rework completed. ",".","320,451 units (255,690 US ; 55,884 Canada; 8877 OUS)","Isolated incidents of ignition inside Grab n' Go cylinders that had been knocked over or otherwise subject to significant physical impact. ",11/16/2012,"11/16/2012",1/2/2013,"01/02/2013"
"Biologics",63730,"Terminated","Blood Bank Of Delmarva, Inc","Newark","DE","US","Voluntary: Firm Initiated","Letter","Ohio; Indiana","B-0644-13","Class II","Red Blood Cells Leukocytes Reduced","W036911719674; ",,"1","Blood products, which were collected from a donor in which donor suitability was not adequately determined, were distributed.",11/12/2012,"11/12/2012",3/6/2013,"03/06/2013"
"Biologics",63730,"Terminated","Blood Bank Of Delmarva, Inc","Newark","DE","US","Voluntary: Firm Initiated","Letter","Ohio; Indiana","B-0645-13","Class III","Blood and Blood Products for Reprocessing","W036911719674; ",,"1","Blood products, which were collected from a donor in which donor suitability was not adequately determined, were distributed.",11/12/2012,"11/12/2012",3/6/2013,"03/06/2013"
"Biologics",63731,"Terminated","American National Red Cross The","Pomona","CA","US","Voluntary: Firm Initiated","Other","California","B-0559-13","Class III","Blood and Blood Products for Reprocessing","06GT81779; ",,"1","Blood product, collected from a donor in which donor suitability was not adequately determined, was distributed.",7/3/2012,"07/03/2012",2/13/2013,"02/13/2013"
"Food",63733,"Ongoing","Bakery Cash & Carry Inc.","Ponce","PR","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Puerto Rico only","F-1072-2013","Class II","Butter Cream","no code",,"3,360 units","The firm re-packs the bulk product for retail sale without labeling, just the name of the product handwritten. Therefore, the label does not declare allergens: The ingredient partially hydrogenated vegetable oil contains soybean oil as a sub-ingredient.",11/15/2012,"11/15/2012",3/20/2013,"03/20/2013"
"Food",63733,"Ongoing","Bakery Cash & Carry Inc.","Ponce","PR","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Puerto Rico only","F-1070-2013","Class III","Raspberry Flavor","no code",,"240 units","The firm re-packs the bulk product for retail sale without labeling, just the name of the product handwritten. Therefore, the label does not declare allergens: FD&C Red #40 and Blue #1",11/15/2012,"11/15/2012",3/20/2013,"03/20/2013"
"Food",63733,"Ongoing","Bakery Cash & Carry Inc.","Ponce","PR","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Puerto Rico only","F-1071-2013","Class II","Butter Flavor","no code",,,"The firm re-packs the bulk product for retail sale without labeling, just the name of the product handwritten. Therefore, the label does not declare allergens: FD&C Yellow#5, Yellow #6 and Red #40",11/15/2012,"11/15/2012",3/20/2013,"03/20/2013"
"Food",63733,"Ongoing","Bakery Cash & Carry Inc.","Ponce","PR","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Puerto Rico only","F-1073-2013","Class II","Brandy flavor","no code",,"3,360 units","The firm re-packs the bulk product for retail sale without labeling, just the name of the product handwritten. Therefore, the label does not declare allergens: FD&C Red #40, Yellow#5, Yellow #6, Blue#1 and Sulfites.",11/15/2012,"11/15/2012",3/20/2013,"03/20/2013"
"Food",63735,"Ongoing"," Maplehurst Deli-Bake South Inc","Carrollton","GA","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","FL & GA","F-0872-2013","Class I","Publix 7 Chocolate Split Layers, Net Wt. 12.75 lbs. (24 count), frozen in bulk paper cartons to be frosted and sold individually at the retail stores.","Lot numbers: 2311B00610, 2311B00611, 23110C00611, Lot 231C00610 and 2311A00611.",".",,"Product sample was found to be positive for Listeria monocytogenes.",11/12/2012,"11/12/2012",1/16/2013,"01/16/2013"
"Food",63735,"Ongoing"," Maplehurst Deli-Bake South Inc","Carrollton","GA","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","FL & GA","F-0871-2013","Class I","Publix 7 Yellow Special Blend Layers, Net Wt. 14.25 lbs. (24 count), frozen in bulk paper cartons to be frosted and sold individually at the retail stores.","Lot numbers: 2311B00610, 2311B00611, 23110C00611, Lot 231C00610 and 2311A00611.",".","859 cases (24 units per case)","Product sample was found to be positive for Listeria monocytogenes.",11/12/2012,"11/12/2012",1/16/2013,"01/16/2013"
"Food",63738,"Ongoing","Rio Queen Citrus, Inc","Mission","TX","US","Voluntary: Firm Initiated","Letter","TX, SC, KS, and Canada","F-1517-2013","Class I","The product was originally distributed in a bulk container of 12/1 Dry Pints in boxes labeled ''Karol'' with the Lot No. ''01W45'' stamped in the upper, right-hand corner on the face of the box. The box states ''Distributed by Interstate Fruit & Vegetable'', which is an affiliated business of Rio Queen Citrus, Inc. These packages were distributed at the retail level between November 10th & November 19th, 2012. At the retail level, the tomatoes may have been packaged in an alternative container depending on the area and retailer.","Lot No. ''01W45''",".","840 cases (12 pints per case)","Rio Queen Citrus, Inc. of Mission, TX is recalling 840 cartons of 12/1 Dry Pints of Mexican cherry tomatoes in ''Karol'' brand boxes, because they have the potential to be contaminated with Salmonella, an organism which can cause serious and sometimes fatal infections in young children, frail or elderly people, and others with weakened immune systems. Healthy persons infected with Salmonella often experience fever, diarrhea (which may be bloody), nausea, vomiting and abdominal pain. In rare circumstances, infection with Salmonella can result in the organism getting into the bloodstream and producing more severe illnesses such as arterial infections (i.e., infected aneurysms), endocarditis and arthritis.",11/19/2012,"11/19/2012",6/19/2013,"06/19/2013"
"Biologics",63740,"Terminated","Blood Assurance Inc","Chattanooga","TN","US","Voluntary: Firm Initiated","FAX","Tennessee; Indiana","B-0561-13","Class III","Blood and Blood Products for Reprocessing","W043211073742; ",,"1","Blood products, which were collected from a donor in which donor suitability was not adequately determined, were distributed.",11/7/2012,"11/07/2012",2/13/2013,"02/13/2013"
"Biologics",63740,"Terminated","Blood Assurance Inc","Chattanooga","TN","US","Voluntary: Firm Initiated","FAX","Tennessee; Indiana","B-0560-13","Class II","Red Blood Cells Leukocytes Reduced","W043211073742; ",,"1","Blood products, which were collected from a donor in which donor suitability was not adequately determined, were distributed.",11/7/2012,"11/07/2012",2/13/2013,"02/13/2013"
"Biologics",63741,"Terminated","Blood Assurance Inc","Chattanooga","TN","US","Voluntary: Firm Initiated","FAX","Tennessee; Georgia; Indiana","B-0564-13","Class II","Red Blood Cells Leukocytes Reduced","W043212029454; W043211086744; ",,"2","Blood products, which were collected from a donor in which donor suitability was not adequately determined, were distributed.",11/8/2012,"11/08/2012",2/13/2013,"02/13/2013"
"Biologics",63741,"Terminated","Blood Assurance Inc","Chattanooga","TN","US","Voluntary: Firm Initiated","FAX","Tennessee; Georgia; Indiana","B-0562-13","Class II","Plasma Frozen Cryoprecipitated Reduced","W043212029454; ",,"1","Blood products, which were collected from a donor in which donor suitability was not adequately determined, were distributed.",11/8/2012,"11/08/2012",2/13/2013,"02/13/2013"
"Biologics",63741,"Terminated","Blood Assurance Inc","Chattanooga","TN","US","Voluntary: Firm Initiated","FAX","Tennessee; Georgia; Indiana","B-0563-13","Class II","Cryoprecipitated AHF, Pooled","W043212029454; ",,"1","Blood products, which were collected from a donor in which donor suitability was not adequately determined, were distributed.",11/8/2012,"11/08/2012",2/13/2013,"02/13/2013"
"Biologics",63741,"Terminated","Blood Assurance Inc","Chattanooga","TN","US","Voluntary: Firm Initiated","FAX","Tennessee; Georgia; Indiana","B-0565-13","Class III","Blood and Blood Products for Reprocessing","W043211086744; ",,"1","Blood products, which were collected from a donor in which donor suitability was not adequately determined, were distributed.",11/8/2012,"11/08/2012",2/13/2013,"02/13/2013"
"Biologics",63742,"Terminated","Blood Assurance Inc","Chattanooga","TN","US","Voluntary: Firm Initiated","FAX","Tennessee; Indiana","B-0567-13","Class III","Blood and Blood Products for Reprocessing","W043211076210; ",,"1","Blood products, which were collected from a donor in which donor suitability was not adequately determined, were distributed.",11/6/2012,"11/06/2012",2/13/2013,"02/13/2013"
"Biologics",63742,"Terminated","Blood Assurance Inc","Chattanooga","TN","US","Voluntary: Firm Initiated","FAX","Tennessee; Indiana","B-0566-13","Class II","Red Blood Cells Leukocytes Reduced","W043211076210; ",,"1","Blood products, which were collected from a donor in which donor suitability was not adequately determined, were distributed.",11/6/2012,"11/06/2012",2/13/2013,"02/13/2013"
"Veterinary",63743,"Terminated","Cohoons Elevator Inc.","Midland","MI","US","Voluntary: Firm Initiated","Other","Midland MI area only.","V-137-2013","Class III","Regular Chicken 50# Ingredients: Corn, Wheat, Oats, Oyster shells, Medium Grit, CCC, ADS, Plant Protein Products, Animal Protein Products, Processed Grain By-Products, Roughage Products, Animal Fat procession with DHA, etc","8/6/2012",,"5400lbs (50lb bags)","During an FDA sample collection, the firms 50# Regular Chicken Feed was found to contain mammalian protein. The label does not contain the warning statement.",11/21/2012,"11/21/2012",2/20/2013,"02/20/2013"
"Veterinary",63745,"Ongoing","Carolina Prime Pet","Murphy","NC","US","Voluntary: Firm Initiated","Press Release","AZ, CA, CO, DC, DE, HI, IL, MD, NE, NJ, NV, NM, PA, SD, TX, VA and WY.","V-168-2013","Class I","Priority Total Pet Care, All Natural Bullstrips Dog Treats, 6 Bullstrip, Distributed by Lucerne Foods, Inc., P.O. Box 99, Pleasanton, CA 94566-0009.","UPC 0-21130-42080-3, Lot #20082712 S 3195 and 20090312 S3195",".","64 cases (28,800 pieces)","Product tested positive for Salmonella.",11/15/2012,"11/15/2012",5/29/2013,"05/29/2013"
"Devices",63746,"Ongoing","Abbott Molecular","Des Plaines","IL","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution - USA (nationwide) and internationally to Algeria, Argentina, Australia, Austria, Azerbaijan, Belgium, Bolivia, Brazil, Burkina Faso, Burundi, Cameroon, Canada, Chad, Chile, China, Colombia, Costa Rica, Croatia, Czech Republic, Denmark, Ethiopia, Estonia, Finland, France, Gaza & Jericho, Germany, Greece, Guinea, Haiti, Honduras, Hong Kong, India, Indonesia, Ireland, Israel, Italy, Japan, Kazakhstan, Kenya, Libya, Lithuania, Luxembourg, Malawi, Malaysia, Mali, Mexico, Mozambique, Netherlands, New Zealand, Norway, Pakistan, Panama, Paraguay, Peru, Poland, Portugal, Romania, Russia, Saudi Arabia, Singapore, Slovenia, South Africa, South Korea, Spain, Sweden, Switzerland, Taiwan, Tanzania, Thailand, Turkey, Uganda, Ukraine, United Arab Emirates, United Kingdom, Venezuela, Vietnam and Zambia","Z-0634-2013","Class II","Abbott m2000sp Instrument; an automated fluid handling system for performing sample preparation for nucleic acid testing; Abbott Molecular Inc., Des Plaines, IL 60018 USA; Abbott m2000sp Instrument; an automated system for performing sample preparation for nucleic acid testing; Abbott Molecular Inc., Des Plaines, IL 60018 USA; list 09K14 The Abbott m2000 System is intended for use in performing nucleic acid testing in clinical laboratories.","list 09K14, all serial numbers and all software versions 1.0 - 5.0",".","215 units - U.S., 693 units - ROW","An issue with the m2000sp Instrument software has been identified whereby, after a series of steps, if changes are made to the control or calibrator information on the Sample Extraction Assay Details screen, the changes are not saved. ",12/4/2012,"12/04/2012",1/9/2013,"01/09/2013"
"Food",63747,"Ongoing","Michael's Seafood Inc. DBA Michael's Gourmet & Delicacies","Miami","FL","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Products was distributed in Florida.","F-0866-2013","Class I","Alaskan Wild Smoked Sockeye Salmon in vacuum packed plastic package, labeled in part: MICHAEL'S WILD SOCKEYE SMOKED SALMON***INGREDIENTS: WILD ALASKAN SOCKEYE SALMON, SALT, SUGAR, NATURAL HARDWOOD SMOKE.***KEEP FROZEN UNTIL USE/THAWED UNDER REFRIGERATION IMMEDIATELY BEFORE USE.***DISTRIBUTED BY: MICHAEL'S SEAFOOD INC. 500 NE 185TH STREET, MIAMI FL 33179.***READY TO EAT WITHIN 3 DAYS AFTER OPENING OR BEFORE SELL BY DATE.***","Batch #1443",".","2,440 pieces and 250 lbs. of Trimmings","Michael's Gourmet Delicacies, Miami, FL is recalling their Alaskan Wild Smoked Sockeye Salmon, Batch #1443 (4oz., 8 oz., 16 oz. and Trimmings) after a sample of 4 oz. Smoked Sockeye Salmon tested positive for Listeria Monocytogenes.",10/27/2012,"10/27/2012",1/16/2013,"01/16/2013"
"Food",63750,"Ongoing","Capital City Fruit Co.","Norwalk","IA","US","Voluntary: Firm Initiated","E-Mail","The product was distributed to IA, MO, NE, MN and WI.","F-0867-2013","Class I","Cherry tomatoes packaged in 1 pint clear, plastic clamshells. The clamshells are packaged either 9/1-pint clamshells or 12/1-pint clamshells per case.","P96290001 date code: 4604 P96330002 date code: 4605 P96477001 date code: 4606 P96368001 date code: 4605 P96500001 date code: 4701 P96313001 date code: 4604 P96330007 date code: 4605 P96290006 date code: 4604 P96500006 date code: 4701",".","283/9/1-pint clamshell cases and 190/12/1-pint clamshell cases","The recalled cherry tomatoes are associated with the Rio Queen Citrus, Inc. recall received on November 12, 2012 and used in the packaging of certain lots of Capital Brand Clamshell Cherry tomatoes have the potential to be contaminated with Salmonella.",11/19/2012,"11/19/2012",1/16/2013,"01/16/2013"
"Biologics",63751,"Ongoing","Dept Of Veterans Affairs Office Of Information & Technology","Hines","IL","US","Voluntary: Firm Initiated","E-Mail","Nationwide","B-0673-13","Class II","VistA Blood Establishment Computer Software (VBECS) ","ALL Versions of VistA Blood Establishment Computer Software (VBECS)",,"116 units","Software, with a defect or glitch, was distributed. ",11/2/2012,"11/02/2012",2/13/2013,"02/13/2013"
"Biologics",63752,"Terminated","HCSC-Blood Center","Bethlehem","PA","US","Voluntary: Firm Initiated","Letter","Pennsylvania","B-0589-13","Class II","Platelets Pheresis Leukocytes Reduced Irradiated","W050912011395; ",,"1","Blood products, collected from donors, whose suitability to donate was not adequately determined, were distributed",10/16/2012,"10/16/2012",3/6/2013,"03/06/2013"
"Biologics",63752,"Terminated","HCSC-Blood Center","Bethlehem","PA","US","Voluntary: Firm Initiated","Letter","Pennsylvania","B-0588-13","Class II","Platelets Pheresis Leukocytes Reduced","W050912011395; ",,"1","Blood products, collected from donors, whose suitability to donate was not adequately determined, were distributed",10/16/2012,"10/16/2012",3/6/2013,"03/06/2013"
"Biologics",63753,"Terminated","Interstate Blood Bank, Inc. of Wisconsin","Milwaukee","WI","US","Voluntary: Firm Initiated","FAX","California; Germany,","B-0590-13","Class II","Source Plasma","12MKEC2429; 12MKEC1768; 12MKEC1541; YP037568; 12MKEC0329; YP037263; 12MKEB9768; 12MKEB9345; 12MKEB8835; 12MKEB8518; 12MKEB8146; 12MKEB7593; 12MKEB7276; 12MKEB6896; 12MKEB6468; 12MKEB5975; 12MKEB5649; ",,"17","Blood products, collected from a donor who was previously deferred, were distributed.",11/5/2012,"11/05/2012",3/6/2013,"03/06/2013"
"Biologics",63754,"Terminated","Upstate New York Transplant Services","Buffalo","NY","US","Voluntary: Firm Initiated","Telephone","New York","B-0591-13","Class II","Platelets Pheresis Leukocytes Reduced","W280312701355; ",,"1","Blood product, which did not meet acceptable product specifications, was distributed.",10/8/2012,"10/08/2012",3/6/2013,"03/06/2013"
"Biologics",63755,"Terminated","Suncoast Communities Blood Bank, Inc.","Sarasota","FL","US","Voluntary: Firm Initiated","E-Mail","Florida","B-0592-13","Class II","Red Blood Cells (Apheresis) Leukocytes Reduced","W038612721688 Part A ; W038612721688 Part B; ",,"2","Blood products, which were collected from a donor who traveled to a malarial endemic area, were distributed.",10/19/2012,"10/19/2012",3/6/2013,"03/06/2013"
"Biologics",63757,"Terminated","Carter BloodCare","Bedford","TX","US","Voluntary: Firm Initiated","Letter","Austria; Texas","B-0594-13","Class II","Blood and Blood Products for Reprocessing","W0352112740220; ",,"1","Blood products, collected from a donor who was previously deferred, were distributed",11/9/2012,"11/09/2012",3/6/2013,"03/06/2013"
"Biologics",63757,"Terminated","Carter BloodCare","Bedford","TX","US","Voluntary: Firm Initiated","Letter","Austria; Texas","B-0593-13","Class II","Red Blood Cells Leukocytes Reduced","W0352112740220; ",,"1","Blood products, collected from a donor who was previously deferred, were distributed",11/9/2012,"11/09/2012",3/6/2013,"03/06/2013"
"Biologics",63760,"Ongoing","Immucor Inc","Norcross","GA","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Nationwide; China, Costa Rica, Germany, Ireland, Mexico, Singapore, and Taiwan.","B-0655-13","Class III","Capture-P Indicator Red Cells, 1 x 11.5mL","Lot Nos. 226183, 226184, 226185",,"3","Capture-P Indicator Red Cells, with confirmed weaker than expected reactivity with the weak positive control, were distributed. ",11/19/2012,"11/19/2012",2/13/2013,"02/13/2013"
"Devices",63761,"Ongoing","GE Healthcare, LLC","Waukesha","WI","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution - Worldwide Distribution - USA including AL, AZ, CA, CO, FL,GA, IA, ID, IL, KY, MA, MD, MI, MN, MO, MS, MT, NC, ND ,NE, NM, NV, NY, OH, OR, PA ,TX, VT, WA, WI and WV; and the countries of Australia, Belgium, Canada, China, France, New Zealand, Poland, Saudi Arabia, Switzerland and United Kingdom.","Z-0749-2013","Class I","Giraffe and Panda Bag and Mask Resuscitation System The T-piece Resuscitation System [ventilator, emergency powered resuscitator]/Panda Bag and Mask Resuscitation System provides the basic equipment required for pulmonary resuscitation of infants.","Model M1139612 ",,"276 units total, 109 of those nationwide.","Oxygen and air wall inlet fittings on the back panel of the resuscitation systems were reversed during assembly.",10/15/2012,"10/15/2012",2/20/2013,"02/20/2013"
"Devices",63761,"Ongoing","GE Healthcare, LLC","Waukesha","WI","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution - Worldwide Distribution - USA including AL, AZ, CA, CO, FL,GA, IA, ID, IL, KY, MA, MD, MI, MN, MO, MS, MT, NC, ND ,NE, NM, NV, NY, OH, OR, PA ,TX, VT, WA, WI and WV; and the countries of Australia, Belgium, Canada, China, France, New Zealand, Poland, Saudi Arabia, Switzerland and United Kingdom.","Z-0748-2013","Class I","GE Healthcare - Giraffe and Panda T-Piece Resuscitation System The T-piece Resuscitation System [ventilator, emergency powered resuscitator]/Panda Bag and Mask Resuscitation System provides the basic equipment required for pulmonary resuscitation of infants.","Models M1139417, M1223628, M1192226-072951, M1192226-084200. M1192226-095181, M1192226-104599",,"276 units total, 109 of those nationwide.","Oxygen and air wall inlet fittings on the back panel of the resuscitation systems were reversed during assembly.",10/15/2012,"10/15/2012",2/20/2013,"02/20/2013"
"Biologics",63763,"Terminated","Community Blood Center","Dayton","OH","US","Voluntary: Firm Initiated","Telephone","Ohio","B-0596-13","Class III","Red Blood Cells (Apheresis) Leukocytes Reduced","W035410040122; W035409008681; 3570639; 2455383; 2411381; 120869; 1252005; 1251925; 1249592; ",,"9","Blood products, leukodepleted greater than three days after collection, were distributed.",11/9/2012,"11/09/2012",3/6/2013,"03/06/2013"
"Biologics",63763,"Terminated","Community Blood Center","Dayton","OH","US","Voluntary: Firm Initiated","Telephone","Ohio","B-0595-13","Class III","Red Blood Cells Leukocytes Reduced","W035412052992; W035412053438; ",,"2","Blood products, leukodepleted greater than three days after collection, were distributed.",11/9/2012,"11/09/2012",3/6/2013,"03/06/2013"
"Biologics",63764,"Terminated","New York Blood Center, Inc.","Westbury","NY","US","Voluntary: Firm Initiated","FAX","New York","B-0610-13","Class II","Red Blood Cells (Apheresis) Leukocytes Reduced","W0470100844570; W047009516690; ",,"2","Blood products, collected from a donor who was previously deferred, were distributed.",9/27/2012,"09/27/2012",3/6/2013,"03/06/2013"
"Drugs",63765,"Ongoing","Bracco Diagnostic Inc","Princeton","NJ","US","Voluntary: Firm Initiated","Letter","Nationwide.","D-157-2013","Class I","Isovue -370 (Iopamidol) Injection 76%, Prefilled 10 x 75 mL (NDC 0270-1316-66), 10 x 100 mL (NDC 0270-1316-67), 10 x 125 mL (NDC 0270-1316-68) Power Injector Syringe, Rx Only, Manufactured for Bracco Diagnostics Inc., Princeton, NJ 08543 by Nycomed GmbH 78224 Singen (Germany).","Lot #: 9K37791, Exp 11/12; 9L40746, Exp 12/12; 0A43705, Exp 01/13; 0C57509, 0C57521, Exp 03/13; 0E62913, Exp 05/13",,"5483 syringes (548.3 boxes)","Presence of Particulate Matter; fibers identified as cellulose and polyvinyl",11/21/2012,"11/21/2012",2/13/2013,"02/13/2013"
"Drugs",63765,"Ongoing","Bracco Diagnostic Inc","Princeton","NJ","US","Voluntary: Firm Initiated","Letter","Nationwide.","D-158-2013","Class I","Isovue -300 (Iopamidol) Injection 61% Prefilled, 10 x 100 mL Power Injector Syringe, Rx Only, Manufactured for Bracco Diagnostics Inc., Princeton, NJ 08543 by Nycomed GmbH 78224 Singen (Germany); NDC 0270-1315-67.","Lot #: 9K34572, Exp 11/12; 0A43282, Exp 01/13; 0C56283, Exp 03/13",,"5736 syringes (573.6 boxes)","Presence of Particulate Matter; fibers identified as cellulose and polyvinyl",11/21/2012,"11/21/2012",2/13/2013,"02/13/2013"
"Devices",63767,"Ongoing","Siemens Healthcare Diagnostics, Inc.","Newark","DE","US","Voluntary: Firm Initiated","Letter","Product was distributed within the United States to AL, AZ, CA, DC, FL, LA, MD, MI, MO, NJ, NM, NC, OH, OR, PA, TN, TX, UT, VA, and WA.","Z-0957-2013","Class II","Siemens Dimension(R) Tacrolimus Flex(R) reagent cartridge (DF107). The TACR method is used as an in vitro diagnostic test.","Lot numbers FA3085, exp 2013-03-26; and FA3316, exp 2013-11-12",".","2,976","Siemens has confirmed customer complaints of low patient sample recovery with Dimension(R) TACR Flex(R) lot FA3085. Quality Control (QC) materials have not exhibited low recovery of the same magnitude. Internal method regression testing versus LC/MS has shown an average 25% low bias compared to LC/MS across the assay range. Individual patients, particularly samples with lower TACR values (e.g., less than 5 ng/mL [6.5 nmol/L]), may show a more appreciable difference due to the typical precision of each methodology.",11/27/2012,"11/27/2012",3/27/2013,"03/27/2013"
"Devices",63768,"Ongoing","Fresenius Medical Care Holdings, Inc.","Waltham","MA","US","Voluntary: Firm Initiated","Letter","US Nationwide Distribution","Z-0676-2013","Class III","Fresenius GranuFlo Dry Acid Concentrate For Bicarbonate Dialysis 2.0 K 2.5 Ca 1 Mg 16.5 GAL Catalog Number: OFD2251-3B Product Usage: GranuFlo is indicated in the treatment of acute and chronic renal failure during the hemodialysis treatment.","Lot Numbers: 12NXGF001, 12NXGF003, 12NXGF006, 12NXGF007, 12NXGF013,, 12NXGF015, 12NXGF016, 12NXGF017, 12PXGF001, 12PXGF003, 12PXGF005, 12PXGF007, 12PXGF009, 12PXGF012, 12PXGF013, 12PXGF015, 12PXGF016",".","101,108 units","GranuFlo Dry Acid Concentrate may show discoloration",11/26/2012,"11/26/2012",1/23/2013,"01/23/2013"
"Devices",63768,"Ongoing","Fresenius Medical Care Holdings, Inc.","Waltham","MA","US","Voluntary: Firm Initiated","Letter","US Nationwide Distribution","Z-0684-2013","Class III","Fresenius GranuFlo Naturalyte Dry Acid Concentrate For Bicarbonate Dialysis 3.0K 2,5 Ca 0.75Mg .16.5GAL Catalog Number: OFD2325-3B Product Usage: GranuFlo is indicated in the treatment of acute and chronic renal failure during the hemodialysis treatment.","Lot Number:12PXGF002",".","2711 units","GranuFlo Dry Acid Concentrate may show discoloration",11/26/2012,"11/26/2012",1/23/2013,"01/23/2013"
"Devices",63768,"Ongoing","Fresenius Medical Care Holdings, Inc.","Waltham","MA","US","Voluntary: Firm Initiated","Letter","US Nationwide Distribution","Z-0679-2013","Class III","Fresenius GranuFlo Naturalyte Dry Acid Concentrate For Bicarbonate Dialysis 2.0K 2.25 Ca 1Mg .16.5GAL Catalog Number: OFD2231-3B Product Usage: GranuFlo is indicated in the treatment of acute and chronic renal failure during the hemodialysis treatment.","Lot Numbers:12NXGF005, 12NXGF019, 12PXGF008",".","13,409 units","GranuFlo Dry Acid Concentrate may show discoloration",11/26/2012,"11/26/2012",1/23/2013,"01/23/2013"
"Devices",63768,"Ongoing","Fresenius Medical Care Holdings, Inc.","Waltham","MA","US","Voluntary: Firm Initiated","Letter","US Nationwide Distribution","Z-0678-2013","Class III","Fresenius GranuFlo Naturalyte Dry Acid Concentrate For Bicarbonate Dialysis 3.0K 2.5 Ca 1Mg .16.5GAL Catalog Number: OFD3251-3B Product Usage: GranuFlo is indicated in the treatment of acute and chronic renal failure during the hemodialysis treatment.","Lot Numbers:12NXGF002, 12NXGF014, 12PXGF006,",".","14,240 units","GranuFlo Dry Acid Concentrate may show discoloration",11/26/2012,"11/26/2012",1/23/2013,"01/23/2013"
"Devices",63768,"Ongoing","Fresenius Medical Care Holdings, Inc.","Waltham","MA","US","Voluntary: Firm Initiated","Letter","US Nationwide Distribution","Z-0680-2013","Class III","Fresenius GranuFlo Naturalyte Dry Acid Concentrate For Bicarbonate Dialysis 1.0K 2.0 Ca 1Mg .16.5GAL Catalog Number: OFD1201-3B Product Usage: GranuFlo is indicated in the treatment of acute and chronic renal failure during the hemodialysis treatment.","Lot Number:12NXGF009",".","5 units","GranuFlo Dry Acid Concentrate may show discoloration",11/26/2012,"11/26/2012",1/23/2013,"01/23/2013"
"Devices",63768,"Ongoing","Fresenius Medical Care Holdings, Inc.","Waltham","MA","US","Voluntary: Firm Initiated","Letter","US Nationwide Distribution","Z-0682-2013","Class III","Fresenius GranuFlo Naturalyte Dry Acid Concentrate For Bicarbonate Dialysis 2.0K 2,5 Ca 0.75Mg .16.5GAL Catalog Number: OFD2223-3B Product Usage: GranuFlo is indicated in the treatment of acute and chronic renal failure during the hemodialysis treatment.","Lot Number:12NXGF012",".","2493 units","GranuFlo Dry Acid Concentrate may show discoloration",11/26/2012,"11/26/2012",1/23/2013,"01/23/2013"
"Devices",63768,"Ongoing","Fresenius Medical Care Holdings, Inc.","Waltham","MA","US","Voluntary: Firm Initiated","Letter","US Nationwide Distribution","Z-0677-2013","Class III","Fresenius GranuFlo Naturalyte Dry Acid Concentrate For Bicarbonate Dialysis 2.0K 2.0 Ca 1Mg .16.5GAL Catalog Number: OFD2201-3B Product Usage: GranuFlo is indicated in the treatment of acute and chronic renal failure during the hemodialysis treatment.","Lot Numbers:12NXGF004, 12NXGF008, 12PXGF010, 12PXGF014",".","17,782 units","GranuFlo Dry Acid Concentrate may show discoloration",11/26/2012,"11/26/2012",1/23/2013,"01/23/2013"
"Devices",63768,"Ongoing","Fresenius Medical Care Holdings, Inc.","Waltham","MA","US","Voluntary: Firm Initiated","Letter","US Nationwide Distribution","Z-0683-2013","Class III","Fresenius GranuFlo Naturalyte Dry Acid Concentrate For Bicarbonate Dialysis 3.0K 2,0 Ca 1.0Mg .16.5GAL Catalog Number: OFD3201-3B Product Usage: GranuFlo is indicated in the treatment of acute and chronic renal failure during the hemodialysis treatment.","Lot Number:12PXGF017",".","670 units","GranuFlo Dry Acid Concentrate may show discoloration",11/26/2012,"11/26/2012",1/23/2013,"01/23/2013"
"Devices",63768,"Ongoing","Fresenius Medical Care Holdings, Inc.","Waltham","MA","US","Voluntary: Firm Initiated","Letter","US Nationwide Distribution","Z-0681-2013","Class III","Fresenius GranuFlo Naturalyte Dry Acid Concentrate For Bicarbonate Dialysis 2.0K 2,5 Ca 0.75 Mg .16.5GAL Catalog Number: OFD2225-3B Product Usage: GranuFlo is indicated in the treatment of acute and chronic renal failure during the hemodialysis treatment.","Lot Numbers:12NXGF011, 12PXGF004",".","5,689 units","GranuFlo Dry Acid Concentrate may show discoloration",11/26/2012,"11/26/2012",1/23/2013,"01/23/2013"
"Devices",63769,"Ongoing","Medtronic Inc. Cardiac Rhythm Disease Management","Saint Paul","MN","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution--USA (nationwide) including the states of AZ, CA, CT, FL, GA, IL IA, MD, MA, MI, MS, NJ, NY, OH, OK, SC, TN, TX and WI. and the countries of CANADA and MALAYSIA.","Z-0618-2013","Class II","Medtronic Intersept Custom Tubing Pack with or without coating ( Carmeda BioActive Surfact, Carmeda BioActive Surfact and Trillium Biosurface,or Balance Biosurface) with the following Model numbers: 0E27R16, 1A30R6, 2493R24, 2493R25, 5D56R5, 5Z93R4, 5Z93R5, 7E64R2, 7J53R2, 7M13R1, 7M14R1, 7N16R, 7P25R1, 7P93R1, 7Q11R1, BB7L63R2, BB7N26R, CB5174R11, CB175R13, CB5Q03R6, CB5Q03R7, CB6C53R6, CB7C15R2, CB7C59R2, CB7C60R2, CB7C74R2, CB7D91R5, CB7E35R2, CB7E38R1, CB7G21R4, CB7L48R1, CB7L72R1, CB7P82R1, HY6U96R2, HY6Y52R2, HY7E87R1, SS7J91R3, SSCB7L48R, SSTL7G78R1,TL5S33R7, TL6VTTR1, TL7B51R1, TL7G20R3, TL7G78R3, TL7R87R1. Sterilized Using Ethylene Oxide, Nonpyrogenic, Assembled in Mexico, Manufacturer Medtronic, Inc, Minneapolis, Mn 55432 Product is used by perfusionists as part of the extracorporeal circuit during cardiopulmonary bypass procedures, and is configured specifically as designated by each customer. ","Pack Model Pack Lot 0E27R16- 11239917 11252800 11264666; 1A30R6- 12132577 12219267; 2493R24- 11187015 11199707 11224309 11227205 11556735; 2493R25- 11646941 11713200 11745242 11813334 11852673 11886412 11990393 12033630 12114699 12178107 12191642 12450856; 5D56R5- 11298229 11357085 11465358 11541270 11601193 11654853 11702415 11745232 11766305 11822320 11838721 11852677 11930380 12024708 12166379 12292156; 5Z93R4- 11713132 11736880 11749958 11766283 11808651 11860604 11878689 11911068 11948473 5Z93R5- 12236493; 12411746 7E64R2- 11933798; 7J53R2- 12172725; 7M13R1- 12168157; 7M14R1- 12349772; 7N16R- 12349786; 7P25R1- 12327801 12449801 12457250; 7P93R1- 12349795 12374420; 7Q11R1- 12344028 12456303; BB7L63R2- 12408737; BB7N26R- 12312571; CB5174R11- 11293051 11315344 11334856 11489271 11745162 11886341 11977682 12019852 12062713 12098852 12139621 12146752 12258941 12277502 12326468 12421465 206110946; CB5175R13- 11292866 11334859 11432873 11442937 12182778 12411655; CB5Q03R6- 11713162 11766245 11787583 11923139 11934952; CB5Q03R7- 12114626; CB6C53R6- 12423767; CB7C15R2- 12411647; CB7C59R2- 11731501; 11813316 11838743 11869767 11908794 11982413 12019907 12146796 12151706 12201727 12292133 12423702; CB7C60R2- 11687047 11724030 11843434 11878672; CB7C74R2- 11895167; CB7D91R5- 11961280 12130493 12146882 12191604 12277455 12411687 12423760; CB7E35R2- 11839101; CB7E38R1- 11843886 11885844 11990360 12105025 12133083 12159400; CB7G21R4- 12032413 1",".","1552 ","Medtronic is initiating an Urgent Medical Device Customer Notification. We have confirmed that certain Medtronic Intersept Tubing Packs contain packaging trays that are susceptible to damage that can compromise product sterility. ",11/19/2012,"11/19/2012",1/9/2013,"01/09/2013"
"Devices",63771,"Ongoing","Perkinelmer","Waltham","MA","US","Voluntary: Firm Initiated","E-Mail","Nationwide Distribution.","Z-0686-2013","Class II","NEOGRAM AMINO ACIDS AND ACYLCARNITINES TANDEM MASS SPECTROMETRY KIT Product Number: 3026-0030. This kit is intended for the measurement and evaluation of amino acid, free carnitine, and acylcarnitine concentrations from newborn heel prick blood samples dried on filter paper. (Table 1 of Attachment 2) details the analytes measured by the kit. Quantitative analysis of amino acids, free carnitine and acylcarnitines and their relationship with each other is intended to provide analyte concentration profiles that may aid in the screening of newborns for one or more of several metabolic disorders. This kit is to be used for in vitro diagnostic use only, by trained, qualified laboratory personnel.","Lot Numbers: 617341, 619236",".","180 kits (20 plates/kit)","Truncated V-Bottomed Microplate Wells used in assays contain defective wells.",11/26/2012,"11/26/2012",1/23/2013,"01/23/2013"
"Devices",63771,"Ongoing","Perkinelmer","Waltham","MA","US","Voluntary: Firm Initiated","E-Mail","Nationwide Distribution.","Z-0688-2013","Class II","NEONATAL TOTAL GALACTOSE KIT Product Numbers: 3029-0010, 3029-001B. This kit is intended for the quantitative determination of total galactose (galactose and galactose-1-phosphate) concentrations in blood specimens dried on filter paper as an aid in screening newborns for galactosemia.","Lot Numbers: 618201, 619200, 618263",".","3029-0010 =1562 kits (10 plats/kit) and 3029-001B=13 kits (50plates/kit) ","Truncated V-Bottomed Microplate Wells used in assays contain defective wells.",11/26/2012,"11/26/2012",1/23/2013,"01/23/2013"
"Devices",63771,"Ongoing","Perkinelmer","Waltham","MA","US","Voluntary: Firm Initiated","E-Mail","Nationwide Distribution.","Z-0689-2013","Class II","DBS MICROPLATE, TRUNCATED V-BOTTOMED Product Number: 3033-0010","Lot Numbers: 618609",".","56 kits (100 plates/kit)","Truncated V-Bottomed Microplate Wells used in assays contain defective wells.",11/26/2012,"11/26/2012",1/23/2013,"01/23/2013"
"Devices",63771,"Ongoing","Perkinelmer","Waltham","MA","US","Voluntary: Firm Initiated","E-Mail","Nationwide Distribution.","Z-0690-2013","Class II","Microplate, truncated V-bottomed lots included in the above listed products Product Number: 1380 5465. DBS Microplate is a general purpose 96 well microplate used in the preparation and examination of specimens from the human body.","Lot Numbers: 616792 , 617141 , 617980 , 618319, 618664, 618831, 619175",".",,"Truncated V-Bottomed Microplate Wells used in assays contain defective wells.",11/26/2012,"11/26/2012",1/23/2013,"01/23/2013"
"Devices",63771,"Ongoing","Perkinelmer","Waltham","MA","US","Voluntary: Firm Initiated","E-Mail","Nationwide Distribution.","Z-0687-2013","Class II","NEOBASE NON-DERIVATIZED MSMS KIT Product Number: 3040-001U. This tandem mass spectrometry (MSMS) reagent kit is intended for the measurement and evaluation of amino acids, succinylacetone, free carnitine, and acylcarnitine concentrations from newborn heel prick blood samples dried on filter paper. Quantitative analysis of these analytes ) and their relationship with each other is intended to provide analyte concentration profiles that may aid in screening newborns for metabolic disorders.","Lot Numbers: 617253 , 617346, 618494 , 618653, 618764 , 619453",".","819 kits (10 plates/kit)","Truncated V-Bottomed Microplate Wells used in assays contain defective wells.",11/26/2012,"11/26/2012",1/23/2013,"01/23/2013"
"Devices",63772,"Ongoing","Hospira Inc.","Lake Forest","IL","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution -- USA, including Puerto Rico, and the countries of Austria, Australia, Argentina, Bahrain, Belgium, Brazil, Canada, Chile, Colombia, Denmark, Finland, France, Greece, Hong Kong, Indonesia, Ireland, Israel, Italy, Jordan, Kuwait, Lebanon, Libya, Malaysia, Mexico, Netherlands, New Zealand, Oman, Pakistan, Peru, Philippines, Poland, Portugal, Saudi Arabia, Singapore, Slovenia, Spain, Sweden, Switzerland, Taiwan, Turkey, United Kingdom, United Arab Emirates, and Vietnam.","Z-0625-2013","Class II","Plum A+3 Triple Channel Infusion Pumps; Hospira, Inc., Lake Forest, IL 60045; the pumps were sold under the following configurations: a) list 12348 - software version 10.3; b) list 12618 - software version 11.3; c) list 20678 - Hospira MedNet software; Product Usage: The Plum A+3 is a dual-line triple channel volumetric infusion system that provides precise delivery of multiple i.v. therapies across the general spectrum of clinical care, including ICU/CCU, OR, PACU, ER, Med/Surg, Pediatrics, Outpatient clinics and Home care ","list numbers 12348, 12618, and 20678; all serial numbers ",".","28,599 units","The door roller assembly on the Plum A+/A+3 infuser family of infusers has the potential to break which can lead to possible unrestricted flow and/or over-delivery during the removal of the IV administration set's cassette from the pump.",12/7/2012,"12/07/2012",1/9/2013,"01/09/2013"
"Devices",63772,"Ongoing","Hospira Inc.","Lake Forest","IL","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution -- USA, including Puerto Rico, and the countries of Austria, Australia, Argentina, Bahrain, Belgium, Brazil, Canada, Chile, Colombia, Denmark, Finland, France, Greece, Hong Kong, Indonesia, Ireland, Israel, Italy, Jordan, Kuwait, Lebanon, Libya, Malaysia, Mexico, Netherlands, New Zealand, Oman, Pakistan, Peru, Philippines, Poland, Portugal, Saudi Arabia, Singapore, Slovenia, Spain, Sweden, Switzerland, Taiwan, Turkey, United Kingdom, United Arab Emirates, and Vietnam.","Z-0626-2013","Class II","Plum A+ Hyperbaric Single Channel Infusion Pumps; Hospira, Inc., Lake Forest, IL 60045; list number 11005 Product Usage: The Plum A+ Hyperbaric Infusion System is exclusively designed for hyperbaric therapy in monospace and multiplace chambers.","list number 11005; all serial numbers ",".","180 units","The door roller assembly on the Plum A+/A+3 infuser family of infusers has the potential to break which can lead to possible unrestricted flow and/or over-delivery during the removal of the IV administration set's cassette from the pump.",12/7/2012,"12/07/2012",1/9/2013,"01/09/2013"
"Devices",63772,"Ongoing","Hospira Inc.","Lake Forest","IL","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution -- USA, including Puerto Rico, and the countries of Austria, Australia, Argentina, Bahrain, Belgium, Brazil, Canada, Chile, Colombia, Denmark, Finland, France, Greece, Hong Kong, Indonesia, Ireland, Israel, Italy, Jordan, Kuwait, Lebanon, Libya, Malaysia, Mexico, Netherlands, New Zealand, Oman, Pakistan, Peru, Philippines, Poland, Portugal, Saudi Arabia, Singapore, Slovenia, Spain, Sweden, Switzerland, Taiwan, Turkey, United Kingdom, United Arab Emirates, and Vietnam.","Z-0624-2013","Class II","Plum A+ Single Channel Infusion Pumps; Hospira, Inc., Lake Forest, IL 60045; the pumps were sold under the following configurations: a) list 11971; b) list 11973 - software version 10.3; c) list 12391 - software version 11.3; d) list 20679 - Hospira MedNet Software e) list 20792 - Hospira MedNet Software; Product Usage: The Plum A+ Infusion System is a dual-line volumetric infusion pump that provides precise delivery of multiple i.v. therapies across the general spectrum of clinical care, including ICU/CCU, OR, PACU, ER, Med/Surg, Pediatrics, Outpatient clinics and Home care ","list numbers 11971, 11973, 12391, 20679, and 20792; all serial numbers ",".","297,833 units","The door roller assembly on the Plum A+/A+3 infuser family of infusers has the potential to break which can lead to possible unrestricted flow and/or over-delivery during the removal of the IV administration set's cassette from the pump.",12/7/2012,"12/07/2012",1/9/2013,"01/09/2013"
"Biologics",63778,"Terminated","Mississippi Blood Services Inc.","Flowood","MS","US","Voluntary: Firm Initiated","FAX","Mississippi","B-0679-13","Class II","Red Blood Cells Leukocytes Reduced","W069112124448; ",,"1","Blood product, collected from a donor who reported travel to a malarial endemic area, was distributed.",10/4/2012,"10/04/2012",3/20/2013,"03/20/2013"
"Biologics",63779,"Terminated","Florida's Blood Centers - Lake Park","Palm Beach Gardens","FL","US","Voluntary: Firm Initiated","Letter","Florida","B-0676-13","Class II","Red Blood Cells Leukocytes Reduced","W038112140935; W038112214027; W038112115492; W038112070188; W038112056857; W038112023793; W038112023467; W038112040729; W038111354805; W038111354804; W038111321390; ",,"11","Blood products, leukoreduced more than three days after collection, were distributed.",10/23/2012,"10/23/2012",3/20/2013,"03/20/2013"
"Biologics",63780,"Terminated","Florida's Blood Centers, Inc.","Orlando","FL","US","Voluntary: Firm Initiated","Letter","Florida","B-0675-13","Class II","Red Blood Cells Leukocytes Reduced","W038111368727; W038111244184; W038111244903; W038111240489; W038111189594; W038111181167; ",,"6","Blood products, leukoreduced more than three days after collection, were distributed.",10/23/2012,"10/23/2012",3/20/2013,"03/20/2013"
"Devices",63783,"Ongoing","DePuy Orthopaedics, Inc.","Warsaw","IN","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution - US Nationwide in the states of AL, AZ, CA, CO, FL, GA, ID, IL, MA, MD, MI, MN, NC, NM, NV, NY, OH, PA, SC, SD, TN, TX, VA, WA, WI, and WV and the countries of Holland, Australia, Austria, South Africa and Canada including Veteran Administration hospitals.","Z-0830-2013","Class I","LPS Diaphyseal Sleeves Product Usage: The LPS Diaphyseal Sleeves are used with the LPS System which is an end-stage revision knee product that allows surgeons to reconstruct severe soft tissue and bony defects. ","Part number: 198720024 and Lot numbers: 113812, 123509, 140578, 156210, 171659, 171660, 171661, 171662, 171663, 123509A, B34GE1000, B34GEA000, B4EGR1000, B4EGRA000, B4EGRB000, B4XFL1000, B4XFLA000, B5SH11000, B5SH1A000, B5SH1B, C74J11000, D14KG1000, E4RF21000, EN8CY1000, EN8CYA000, FC1MB1, and FC1MBA. ",".","162 total units (US) and 102 units total (OUS)","DePuy Orthopaedics is initiating a voluntary recall of the LPS Diaphyseal sleeve because the product has the potential for fracture at the taper junction. The LPS Diaphyseal Sleeve to Diaphyseal Sleeve Base taper connection may not be sufficient to accommodate potential physiologic loads that may be transferred to the junction during normal gait activities by some patients.",1/4/2013,"01/04/2013",2/27/2013,"02/27/2013"
"Devices",63783,"Ongoing","DePuy Orthopaedics, Inc.","Warsaw","IN","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution - US Nationwide in the states of AL, AZ, CA, CO, FL, GA, ID, IL, MA, MD, MI, MN, NC, NM, NV, NY, OH, PA, SC, SD, TN, TX, VA, WA, WI, and WV and the countries of Holland, Australia, Austria, South Africa and Canada including Veteran Administration hospitals.","Z-0828-2013","Class I","LPS Diaphyseal Sleeves Product Usage: The LPS Diaphyseal Sleeves are used with the LPS System which is an end-stage revision knee product that allows surgeons to reconstruct severe soft tissue and bony defects. ","Part number: 198720018 and Lot numbers: 123506, 123507, 156208, 188414, 202951, 212351, B34GC1000, B4EGN1000, B4SBM1000, B5SHY1000, DH8F91000, DH8F9A000, DH8F9B000, DH8F9C, and FE5LL1.",".","162 total units (US) and 102 units total (OUS)","DePuy Orthopaedics is initiating a voluntary recall of the LPS Diaphyseal sleeve because the product has the potential for fracture at the taper junction. The LPS Diaphyseal Sleeve to Diaphyseal Sleeve Base taper connection may not be sufficient to accommodate potential physiologic loads that may be transferred to the junction during normal gait activities by some patients.",1/4/2013,"01/04/2013",2/27/2013,"02/27/2013"
"Devices",63783,"Ongoing","DePuy Orthopaedics, Inc.","Warsaw","IN","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution - US Nationwide in the states of AL, AZ, CA, CO, FL, GA, ID, IL, MA, MD, MI, MN, NC, NM, NV, NY, OH, PA, SC, SD, TN, TX, VA, WA, WI, and WV and the countries of Holland, Australia, Austria, South Africa and Canada including Veteran Administration hospitals.","Z-0829-2013","Class I","LPS Diaphyseal Sleeves Product Usage: The LPS Diaphyseal Sleeves are used with the LPS System which is an end-stage revision knee product that allows surgeons to reconstruct severe soft tissue and bony defects. ","Part number: 198720020 and Lot numbers: 140576, 156212, 156213, 156214, 162644, 188411, 202954, 156214A, 202954A, B34GD1000, B4SBN1000, B4SBNA000, B4SBNB000, B4SBNC000, B5RAW1000, B5RAWA000, C3RHJ1000, C74JX1000, C74JXA, E18N61000, E3PKV1000, EF8GB1000, and FL2WB1. ",".","162 total units (US) and 102 units total (OUS)","DePuy Orthopaedics is initiating a voluntary recall of the LPS Diaphyseal sleeve because the product has the potential for fracture at the taper junction. The LPS Diaphyseal Sleeve to Diaphyseal Sleeve Base taper connection may not be sufficient to accommodate potential physiologic loads that may be transferred to the junction during normal gait activities by some patients.",1/4/2013,"01/04/2013",2/27/2013,"02/27/2013"
"Devices",63783,"Ongoing","DePuy Orthopaedics, Inc.","Warsaw","IN","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution - US Nationwide in the states of AL, AZ, CA, CO, FL, GA, ID, IL, MA, MD, MI, MN, NC, NM, NV, NY, OH, PA, SC, SD, TN, TX, VA, WA, WI, and WV and the countries of Holland, Australia, Austria, South Africa and Canada including Veteran Administration hospitals.","Z-0831-2013","Class I","LPS Diaphyseal Sleeves Product Usage: The LPS Diaphyseal Sleeves are used with the LPS System which is an end-stage revision knee product that allows surgeons to reconstruct severe soft tissue and bony defects. ","Part number: 198720028 and Lot numbers: 123510, 156211, 212355, B34GG1000, B4TH51000, B5RAX1000, B5RAXA000, B5RAXB000, CC3KX1000, CC3KXA000, E4RF31000, E4RF3A000, E55HV1, and EN4KN1000. ",".","162 total units (US) and 102 units total (OUS)","DePuy Orthopaedics is initiating a voluntary recall of the LPS Diaphyseal sleeve because the product has the potential for fracture at the taper junction. The LPS Diaphyseal Sleeve to Diaphyseal Sleeve Base taper connection may not be sufficient to accommodate potential physiologic loads that may be transferred to the junction during normal gait activities by some patients.",1/4/2013,"01/04/2013",2/27/2013,"02/27/2013"
"Biologics",63789,"Terminated","Amer. National Red Cross-Greater Chesapeake & Potomac Reg.","Baltimore","MD","US","Voluntary: Firm Initiated","FAX","District of Columbia; Maryland","B-0708-13","Class II","Plasma Frozen within 24 hours (FP24)","53H35682; ",,"1","Blood products, collected from a donor whose suitability to donate was not adequately determined, were distributed. ",10/9/2012,"10/09/2012",3/20/2013,"03/20/2013"
"Biologics",63789,"Terminated","Amer. National Red Cross-Greater Chesapeake & Potomac Reg.","Baltimore","MD","US","Voluntary: Firm Initiated","FAX","District of Columbia; Maryland","B-0707-13","Class II","Red Blood Cells Leukocytes Reduced","53H35682; ",,"1","Blood products, collected from a donor whose suitability to donate was not adequately determined, were distributed. ",10/9/2012,"10/09/2012",3/20/2013,"03/20/2013"
"Biologics",63790,"Terminated","Community Blood Centers of Florida, Inc.","Lauderhill","FL","US","Voluntary: Firm Initiated","Telephone","Florida","B-0731-13","Class III","Blood and Blood Products for Reprocessing","W036812573302;",".","1","Blood products, collected from a donor whose suitability to donate was not adequately determined, were distributed.",10/24/2012,"10/24/2012",3/27/2013,"03/27/2013"
"Biologics",63790,"Terminated","Community Blood Centers of Florida, Inc.","Lauderhill","FL","US","Voluntary: Firm Initiated","Telephone","Florida","B-0729-13","Class III","Red Blood Cells","W036812573302;",".","1","Blood products, collected from a donor whose suitability to donate was not adequately determined, were distributed.",10/24/2012,"10/24/2012",3/27/2013,"03/27/2013"
"Biologics",63790,"Terminated","Community Blood Centers of Florida, Inc.","Lauderhill","FL","US","Voluntary: Firm Initiated","Telephone","Florida","B-0730-13","Class III","Platelets Pooled Leukocytes Reduced","W036812846256;",".","1","Blood products, collected from a donor whose suitability to donate was not adequately determined, were distributed.",10/24/2012,"10/24/2012",3/27/2013,"03/27/2013"
"Drugs",63791,"Ongoing","Abbott Laboratories","Abbott Park","IL","US","Voluntary: Firm Initiated","Letter","US Nationwide and Puerto Rico","D-107-2013","Class II","Synthroid (Levothyroxine Sodium) tablets, 150 mcg (0.15 mg), 90 tablets per bottle, Rx Only, NDC 0074-7069-90; ABBOTT LABORATORIES NORTH CHICAGO, IL 60064 U.S.A.","LOT # 18262A8 Exp. 09/13",".","28, 524 bottles","Labeling: Error on Declared Strength. Product labeled to contain 150 mcg tablets actually contained 75 mcg tablets.",12/4/2012,"12/04/2012",1/9/2013,"01/09/2013"
"Food",63792,"Ongoing","Pastry Food Products Inc.","San Juan","PR","US","Voluntary: Firm Initiated","Visit","Puerto Rico only","F-0873-2013","Class II","TRIGAL***Empanadillas de Pizza (Pizza turnovers)***12 ct***Pastry Foods Inc., Rio Piedras, PR","none",".","120 packages of 12 units each","Undeclared milk as the source of cheese.",8/16/2012,"08/16/2012",1/16/2013,"01/16/2013"
"Food",63792,"Ongoing","Pastry Food Products Inc.","San Juan","PR","US","Voluntary: Firm Initiated","Visit","Puerto Rico only","F-0874-2013","Class I","TRIGAL***Pastelillos Coctel de Pizza (Pizza Mini turnovers)***12 ct***Pastry Foods Inc., Rio Piedras, PR","none",".","12 packages of 12 units each","Undeclared milk",8/16/2012,"08/16/2012",1/16/2013,"01/16/2013"
"Devices",63793,"Ongoing","The Anspach Effort, Inc.","Palm Beach Gardens","FL","US","Voluntary: Firm Initiated","Letter","Distributed in the state of Massachusetts","Z-0783-2013","Class II","Anspach Effort, Inc., 98-0061 MA-15C Bearing Sleeve with Removable Bur Guard. A reusable device used with dissection tools; designed for Transphenoidal and Skull base procedures.","Lot number: 2000930",,"8 devices","Contact between the bur and bur guard could generate metal fragments that may or may not be visible to the surgeon and can potentially remain in the surgical site. The materials used to fabricate the bur guard are not traceable, design validation did not effectively evaluate adequate protection of adjacent tissue and inspection results for each of these bur guards were not documented.",9/5/2012,"09/05/2012",2/13/2013,"02/13/2013"
"Devices",63794,"Ongoing","Fisher & Paykel Healthcare, Ltd.","North Shore City",,"NZ","Voluntary: Firm Initiated","E-Mail","Worldwide Distribution - USA including IL, IN, AR and GA.","Z-0621-2013","Class I","Fisher & Paykel Healthcare reusable breathing circuit. Non-heated breathing circuit, 1.8m or 6 feet in length. Oxygen therapy delivery system for adult patient.","Lots 110810 and 111020",".","200 units total, 26 units US","FPH has become aware that one batch of tubes supplied to FPH may contain hole damage. These tubes were incorporated by FPH into certain 900MR068 reusable circuits with lot numbers 110810 and 111020. If this hole damage is not detected during the standard leak test before patient use, it could potentially result in a gas leak in the breathing system, which may lead to a loss of pressure for the intended ventilation therapy.",11/19/2012,"11/19/2012",1/9/2013,"01/09/2013"
"Biologics",63796,"Ongoing","Blood Bank Computer Systems, Inc","Auburn","WA","US","Voluntary: Firm Initiated","Letter","Software was distributed to blood banks nationwide.","B-0726-13","Class III","Blood Bank Control System (BBCS) Primary Application 5.0 - software for device.","BBCS Primary Application 5.3.4, 5.3.5, 5.3.6, 5.3.7, 5.3.8, 5.4.0 and 5.4.0.1",,"7","Blood Bank software, with a defect or glitch, was distributed.",10/18/2011,"10/18/2011",2/13/2013,"02/13/2013"
"Biologics",63797,"Ongoing","Blood Bank Computer Systems, Inc","Auburn","WA","US","Voluntary: Firm Initiated","Letter","Software was distributed nationwide.","B-0727-13","Class II","Blood Bank Computer Systems (BBCS) Primary Application 5.0 - device software","BBCS Primary Application 5.0, 5.1, 5.2, 5.2.1, 5.2.2, 5.3.0, 5.3.1, 5.3.2, 5.3.3, 5.3.4, 5.3.5, 5.3.6, 5.3.7, 5.3.8, 5.4.0 and 5.4.0.1",,"16","Blood Bank software, with a defect or glitch possibly causing mislabeling blood products with a donor's CMV status, was distributed.",11/1/2011,"11/01/2011",2/13/2013,"02/13/2013"
"Food",63798,"Ongoing","Acme Food Sales, Inc","Seattle","WA","US","Voluntary: Firm Initiated","Telephone","The product was distributed to one wholesaler - Associated Food Stores (AFS) Farr West, Far West, Utah. The January 31, 2015 code was first not thought to have been distributed to retail, however; Associated Food Stores corrected this information and issued a second recall notice because the product had been distributed from their warehouse to retail. Lot codes with Best Buy: DEC 15 2014 and DEC 15 2014 were not distributed out of Acme's warehouse and are currently under their control.","F-0969-2013","Class III","Canned mandarin oranges labeled in part: ''WESTERN FAMILY Choice Selections Mandarin Oranges Naturally Sweet in Mandarin Orange Juice NET WT 10.5OZ (297g)***Ingredients: Mandarin Oranges, Mandarin Orange Juice. Proudly Distributed by Western Family P.O. Box 4057, Portland, OR 97208 U.S.A.***Product of China***0 15400 01241 6***''","Can Code: S8 4500/01068 601 ORJ Best By Dates: NOV 14, 2014; DEC 14, 2014; DEC 15, 2014 and JAN 31, 2015 Case UPC: 100 15400 01241 3 Can UPC: 0 15400 01241 6",,"8707 cs (24 cans/cs)","The firm received two consumer complaints regarding chemical smell/taste and tasting like the can. As a result the firm began extensive testing of its inventory. Preliminary testing identified a contaminant was present. Further testing is pending to specifically identify the contaminant.",11/30/2012,"11/30/2012",2/13/2013,"02/13/2013"
"Food",63799,"Ongoing","The Warrell Corporation","Camp Hill","PA","US","Voluntary: Firm Initiated","Telephone","Product was distributed to retailers in DE, FL, GA, MD, MO, NH, NJ, NY, PA, VA, and WV.","F-1864-2013","Class I","Chocolate covered raisinsin 4 oz flexible bags labeled in part ''***Pennsylvania Dutch Candies***Chocolate Covered Raisins***NET WT 4 OZ (113g)***Packed for Pennsylvania Dutch Candies Camp Hill, PA***Manufactured In A Facility That Also Processes Peanuts***''. ","Lot Code: 4832B ",".","51 cases/12-4 oz bags per case","Chocolate Covered Peanuts were mislabeled with Chocolate Covered Raisins label; therefore Peanut Allergen is not identified. Affected consignees were contacted in November, 2012.",11/30/2012,"11/30/2012",9/11/2013,"09/11/2013"
"Devices",63800,"Ongoing","Mindray DS USA, Inc. d.b.a. Mindray North America","Mahwah","NJ","US","Voluntary: Firm Initiated","Letter","US Nationwide Distribution including the states of: VA, TN, FL, & TX","Z-0742-2013","Class II","Mindray, DPM5 Monitor, a vital signs monitor used on human patients in healthcare facilities.","p/n 9201F-PA000XX DS- 0C000565 02000335 12000603 12000599 12000597 0C000569 9A000247 9A000252 17000648 06000490 05000470 05000466 02000373",".","13 units","Mindray has identified an issue with the DPM5 monitors where ST and Arrhythmia features may not be available.",9/5/2012,"09/05/2012",2/6/2013,"02/06/2013"
"Food",63802,"Ongoing","Cho Fuku Group (usa) Inc","El Monte","CA","US","Voluntary: Firm Initiated","Letter","California and Washington","F-0855-2013","Class II","Sanh Yuan Preserved Plum Candy (Sweet and Sour Prune), 5 oz (142g)","The manufacturer did not use lot number or code number",".","430 packs","CHO Fuku Group Inc. is recalling Sanh Yuan Preserved Plum Candy (Sweet and Sour Prune) because of unacceptable levels of lead.",11/16/2012,"11/16/2012",1/9/2013,"01/09/2013"
"Devices",63803,"Ongoing","sanofi-aventis US, Inc.","Bridgewater","NJ","US","Voluntary: Firm Initiated","Other","Worldwide distribution.","Z-0609-2013","Class II","Diamigo i-Phone App The Diamigo app was intended for use as an educational tool in the management of diabetes.","n/a",".","1600 downloads (140 US; 1460 Foreign)","Diamigo, a software application, was released through the i-Phone Global Store which inadvertently allowed global access to the application as opposed to the original intended restriction of access to Brazil.",9/21/2012,"09/21/2012",1/2/2013,"01/02/2013"
"Devices",63804,"Ongoing","Siemens Healthcare Diagnostics, Inc.","Newark","DE","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution-USA (nationwide) including the states of AL, AR, AZ, CA, CO, CT, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI, and WV and Puerto Rico and the country of Canada.","Z-1073-2013","Class II","Dade(R) Actin(R) FSL Activated PTT Reagent. For use in the determination of the activated partial thromboplastin time (APTT).","Catalog numbers B4219-1 and B4219-2: lot numbers 547311, exp 3/22/2013; 547312, exp 3/22/2013 and 547316A, exp 4/28/2013.",,"13,083","Siemens has observed that the listed lot numbers show an increase in Heparin sensitivity over the shelf life which is demonstrated by testing with Dade(R) Citrol(R) Heparin Control, low and high.",3/11/2013,"03/11/2013",4/17/2013,"04/17/2013"
"Devices",63805,"Ongoing","Extremity Medical LLC","Parsippany","NJ","US","Voluntary: Firm Initiated","E-Mail","Worldwide Distribution -- Nationwide Distribution including the states of AR, AZ, CA, FL, GA, IL, IN, MD, MT, NC, NE, NH, NJ, NY, OH, PA, TN, TX, WI and WA.","Z-0752-2013","Class II","Extremity Medical, IO FiX System Accessory. Catalog Number 101-00010. This screw measuring device is an accessory to the IO FiX Screw and Washer System that is used to measure the length of the screw by placing the depth gauge over the guidewire and down to the bone. Orthopedic implant.","Catalog Number 101-00010 Lot number AP3V12 AP4E01 AP4N04 AP5E25 AP6A44 AP6E42 AP6L14 AP6M17 AP6T08.",".","93 units","Lag screw measurement is short (approximately 5 mm) when using current screw measuring device (p/n 101-00010) per the IO FIX Surgical Technique Rev C. which can lead to possible inappropriate implant size selection (e.g. shorter screw size selected).",3/22/2012,"03/22/2012",2/6/2013,"02/06/2013"
"Devices",63809,"Ongoing","Siemens Healthcare Diagnostics Inc","Norwood","MA","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution - USA (nationwide) and internationally to Canada, Aruba, Brazil, Denmark, India, Mexico, New Zealand, Singapore,Thailand, Bahamas, South Wales, and Hong Kong,","Z-0640-2013","Class II","Siemens Chek-Stix Combo Pak (Distributed OUS only) Catalog Number: 1364N Chek-Stix Positive and Negative Control Strips for Urine Chemistry: When used with Siemens reagent strips and tablets for urinalysis, CHEK-STIX positive and negative control strips provide defined results for glucose, bilirubin, ketone (acetoacetic acid), specific gravity, blood, pH, protein, urobilinogin, nitrite, and leukocytes","Carton/BottleLot Number: C0099091A P0099091A C0100101 H P0100101 H C0103042C P0103042C ",".","1130","When these lots of control material are reconstituted, the positive control solution leukocyte result may become negative if the solution is held for more than two hours above 25C (77F).",11/21/2012,"11/21/2012",1/16/2013,"01/16/2013"
"Devices",63809,"Ongoing","Siemens Healthcare Diagnostics Inc","Norwood","MA","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution - USA (nationwide) and internationally to Canada, Aruba, Brazil, Denmark, India, Mexico, New Zealand, Singapore,Thailand, Bahamas, South Wales, and Hong Kong,","Z-0639-2013","Class III","Siemens Chek-Stix Combo Pak (Distributed OUS only) Catalog Number: 1364M Chek-Stix Positive and Negative Control Strips for Urine Chemistry: When used with Siemens reagent strips and tablets for urinalysis, CHEK-STIX positive and negative control strips provide defined results for glucose, bilirubin, ketone (acetoacetic acid), specific gravity, blood, pH, protein, urobilinogin, nitrite, and leukocytes","Carton/Bottle Lot Number: CP0099091B P0099091B C0100101G P0100101G C0103042E P0103042E ",".","325","When these lots of control material are reconstituted, the positive control solution leukocyte result may become negative if the solution is held for more than two hours above 25C (77F).",11/21/2012,"11/21/2012",1/16/2013,"01/16/2013"
"Devices",63809,"Ongoing","Siemens Healthcare Diagnostics Inc","Norwood","MA","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution - USA (nationwide) and internationally to Canada, Aruba, Brazil, Denmark, India, Mexico, New Zealand, Singapore,Thailand, Bahamas, South Wales, and Hong Kong,","Z-0641-2013","Class III","Siemens Chek-Stix Combo Pak (Distributed OUS) Catalog Number: 1364E Chek-Stix Positive and Negative Control Strips for Urine Chemistry: When used with Siemens reagent strips and tablets for urinalysis, CHEK-STIX positive and negative control strips provide defined results for glucose, bilirubin, ketone (acetoacetic acid), specific gravity, blood, pH, protein, urobilinogin, nitrite, and leukocytes","Carton/Bottle Lot Number: C0099091C P0099091C C0100101F P0100101F C9101022I P9101022I C0103042D P0103042D C0106062E P0106062E ",".","4642","When these lots of control material are reconstituted, the positive control solution leukocyte result may become negative if the solution is held for more than two hours above 25C (77F).",11/21/2012,"11/21/2012",1/16/2013,"01/16/2013"
"Devices",63809,"Ongoing","Siemens Healthcare Diagnostics Inc","Norwood","MA","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution - USA (nationwide) and internationally to Canada, Aruba, Brazil, Denmark, India, Mexico, New Zealand, Singapore,Thailand, Bahamas, South Wales, and Hong Kong,","Z-0637-2013","Class III","Siemens Chek-Stix Combo Pak Catalog Number: 1364 Chek-Stix Positive and Negative Control Strips for Urine Chemistry: When used with Siemens reagent strips and tablets for urinalysis, CHEK-STIX positive and negative control strips provide defined results for glucose, bilirubin, ketone (acetoacetic acid), specific gravity, blood, pH, protein, urobilinogin, nitrite, and leukocytes","Carton/Bottle Lot Number: C9093061C P9093061C C9094081J P9094081J C0100101D P0100101D C0097091E P0097091E C9101022E P9101022E C0099091D P0099091D C0100101E P0100101E C9101022H P9101022H C9101022J P9101022J C0103042B P0103042B C0103042G P0103042G C0106062D P0106062D C9105052C P9105052C ",".","16711","When these lots of control material are reconstituted, the positive control solution leukocyte result may become negative if the solution is held for more than two hours above 25C (77F).",11/21/2012,"11/21/2012",1/16/2013,"01/16/2013"
"Devices",63809,"Ongoing","Siemens Healthcare Diagnostics Inc","Norwood","MA","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution - USA (nationwide) and internationally to Canada, Aruba, Brazil, Denmark, India, Mexico, New Zealand, Singapore,Thailand, Bahamas, South Wales, and Hong Kong,","Z-0636-2013","Class III","Siemens CLINITEK Atlas Positive and Negative Control Strips for Urine Chemistry Catalog Number: 5019 When used with the CLINITEK ATLAS Automated urine Chemistry Analyzer and CLINITEK ATLAS 10 reagent Pak, CLINITEK ATLAS Positive and Negative Control Strips provide defined results for color, clarity, glucose, bilirubin, ketone (acetoacetic acid), specific gravity, blood, pH, protein, urobilinogen, nitrite, and leukocytes. Each CLINITEK ATLAS Positive Control Strip is a firm plastic strip to which are affixed seven separate analyte areas.","Carton/Bottle Lot Number: S9093061A P9093061A S9094081A P9094081A S0097091C P0097091C S9093061A P9093061A S9094081A P9094081A S0097091C P0097091C S0100101B P0100101B S0103042A P0103042A S0103042H P0103042H S0106062A P0106062A S9101022A P9101022A S9101022B P9101022B S9105052A P9105052A ",".","6466 ","When these lots of control material are reconstituted, the positive control solution leukocyte result may become negative if the solution is held for more than two hours above 25C (77F).",11/21/2012,"11/21/2012",1/16/2013,"01/16/2013"
"Devices",63809,"Ongoing","Siemens Healthcare Diagnostics Inc","Norwood","MA","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution - USA (nationwide) and internationally to Canada, Aruba, Brazil, Denmark, India, Mexico, New Zealand, Singapore,Thailand, Bahamas, South Wales, and Hong Kong,","Z-0635-2013","Class III","Siemens Chek-Stix Positive and Negative Control Strips for Urine Chemistry Catalog Number:1360 Chek-Stix Positive and Negative Control Strips for Urine Chemistry: When used with Siemens reagent strips and tablets for urinalysis, CHEK-STIX positive and negative control strips provide defined results for glucose, bilirubin, ketone (acetoacetic acid), specific gravity, blood, pH, protein, urobilinogin, nitrite, and leukocytes","Carton/Bottle Lot Number: C9093061B P9093061B C9094081B P9094081B C0097091B P0097091B C0100101C P0100101C C0103042F P0103042F C0106062B P0106062B C91 01022D P91 01022D CP9105052B P9105052B C9108092A P9108092A ",".","7865","When these lots of control material are reconstituted, the positive control solution leukocyte result may become negative if the solution is held for more than two hours above 25C (77F).",11/21/2012,"11/21/2012",1/16/2013,"01/16/2013"
"Devices",63809,"Ongoing","Siemens Healthcare Diagnostics Inc","Norwood","MA","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution - USA (nationwide) and internationally to Canada, Aruba, Brazil, Denmark, India, Mexico, New Zealand, Singapore,Thailand, Bahamas, South Wales, and Hong Kong,","Z-0638-2013","Class III","Siemens Chek-Stix Positive and Negative Control Strips for Urine Chemistry (Distributed OUS Only) Catalog Number: 1360L Chek-Stix Positive and Negative Control Strips for Urine Chemistry: When used with Siemens reagent strips and tablets for urinalysis, CHEK-STIX positive and negative control strips provide defined results for glucose, bilirubin, ketone (acetoacetic acid), specific gravity, blood, pH, protein, urobilinogin, nitrite, and leukocytes","Carton/Bottle Lot Number: C9094081C P9094081C C0100101A P0100101A C9101022C P9101022C ",".","700 ","When these lots of control material are reconstituted, the positive control solution leukocyte result may become negative if the solution is held for more than two hours above 25C (77F).",11/21/2012,"11/21/2012",1/16/2013,"01/16/2013"
"Biologics",63810,"Terminated","Banco de Ojos del Leonismo Puertorriqueno","Rio Piedras","PR","US","Voluntary: Firm Initiated","Telephone","Puerto Rico","B-0525-13","Class II","Cornea","20110177; 20110178",".","2","Human Corneas, recovered with a donor with risk factors for relevant communicable disease agents and diseases, were distributed. ",9/18/2012,"09/18/2012",1/30/2013,"01/30/2013"
"Biologics",63812,"Terminated","Community Blood Center of Carolinas","Charlotte","NC","US","Voluntary: Firm Initiated","Telephone","North Carolina","B-0684-13","Class II","Platelets Pheresis Leukocytes Reduced","W227012037073; W227012037073; ",,"2","Blood products, collected from a donor whose eligibility to donate was not adequately determined, were distributed. ",11/4/2012,"11/04/2012",3/20/2013,"03/20/2013"
"Biologics",63813,"Terminated","Inova Health Care Services, Inova Blood Donor Services","Sterling","VA","US","Voluntary: Firm Initiated","FAX","District of Columbia","B-0796-13","Class II","Red Blood Cells Leukocytes Reduced","W089812451534-B",".","1","Blood product, collected from a donor considered to be at increased risk for variant Creutzfeldt-Jakob Disease (vCJD), was distributed.",11/9/2012,"11/09/2012",3/27/2013,"03/27/2013"
"Devices",63814,"Ongoing","Roche Molecular Systems, Inc.","Branchburg","NJ","US","Voluntary: Firm Initiated","Letter","Distributed in the states of GA, CA, NC, and MN.","Z-0614-2013","Class II","COBAS AmpliPrep Instrument (CAP) with AMPLILINK (AL) Software v.3.3.5 Automated sample processing instrument used with CAP/CA and CAP/CTM. Roche Molecular Systems, Inc. 1080 US Highway 202 South Branchburg, NJ 08876 USA Made in Switzerland","CAP 394436 to 394663",".","7 units","Certain COBAS AmpliPrep instruments using AMPILINK software v.3.3.4 had the sample clot detection flagging feature disabled during quality control release resulting in samples that may not be flagged as having clots.",10/11/2012,"10/11/2012",1/2/2013,"01/02/2013"
"Food",63816,"Ongoing","Gourmet Cuisine, Inc.","Mesquite","TX","US","Voluntary: Firm Initiated","E-Mail","TX only","F-0857-2013","Class I","La Madeleine Potato Soup, 5 lb clear Cryovac pouches, 4 pouches per case.","All potato soup manufactured 08/09&10/2012. Expiration dates Aug 21 - Oct 21, 2012",".","127 crates","The potato in the potato soup is treated with sulfites. Sulfites were not declared on the firm's product label.",8/27/2012,"08/27/2012",1/9/2013,"01/09/2013"
"Devices",63817,"Ongoing","Philips Medical Systems (Cleveland) Inc","Cleveland","OH","US","Voluntary: Firm Initiated","Letter","Worldwide distribution: USA including IN, OH and OR; and the countries: Australia, Belgium, China, Israel, and Sweden.","Z-0674-2013","Class II","Brilliance 64 and Ingenuity CT Computed Tomography X-Ray Scanning Systems: Brilliance 64 - Model #728231; and Ingenuity CT - Model # 728326, Distributed By: Philips Healthcare, Cleveland, OH. The Brilliance 64 and Ingenuity CT are Computed Tomography X-Ray Systems intended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission data taken at different angles and planes. These devices may include signal analysis and display equipment, patient, and equipment supports, components and accessories.","Brilliance CT X-RAY System - Model/System Code #728231, Serial Number distributed in the U.S. was: 9654. Ingenuity CT X-Ray System - Model/System Code #728326 - Serial Numbers distributed in the U.S. were: 300018, and 300003. The remaining Serial Numbers distributed overseas were: 91003, 95130, 95157, 95504, and Serial Numbers: 300010, and 300030 .",".","A total of nine (9) units were distributed (3 units in the U.S & 6 units overseas)","Software anomalies. Philips Medical Systems recalled their Brilliance 64 running software v4.0.0xx516 and their Ingenuity CT running software v4.0.0xx518 due to software issues detected in these CT scanning systems. If these issues were to re-occur they could pose the risk of injury to patients undergoing scans; device users; or device service personnel.",12/3/2012,"12/03/2012",1/23/2013,"01/23/2013"
"Drugs",63818,"Ongoing","Vintage Pharmaceuticals LLC DBA Qualitest Pharmaceuticals","Huntsville","AL","US","Voluntary: Firm Initiated","Press Release","Nationwide and Puerto Rico","D-138-2013","Class I","Hydrocodone bitartrate and acetaminophen Tablets, USP, 10 mg/500 mg, packaged in a) 30-count bottles, NDC 0603-3888-16; b) 60-count bottles, NDC 0603-3888-20; c) 90-count bottles, NDC 0603-3888-02; d) 100-count bottles, NDC 0603-3888-21; e) 120-count bottles, NDC 0603-3888-22; f) 150-count bottles, NDC 0603-3888-26; g) 180-count bottles, NDC 0603-3888-04; h) 500-count bottles, NDC 0603-3888-28; and i) 1000-count bottles, NDC 0603-3888-32, Rx only, Mfg. for: Qualitest Pharmaceuticals, Huntsville, AL 35811.","Lot #: All that begin with the letter ''C'' a) C1160712C, Exp 12/13; b) C0930812A, C1110412A, C1141012B, C1160712A, Exp 12/13; c) C0950812B, C1110412B, C1151012B, C1160712B, C1530512A, Exp 12/13; d) C0540212A, C0550212A, C0560212A, C0710312A, C0720312A, C0730112B, C0730312A, C0740112B, C0740312A, C0750112A, C0760112A, C0770112C, C0780112C, C0790112C, C0860812A, C0870812A, C0880812A, C0890812A, C0900812A, C0910812A, C0920812A, C0950412A, C0950812D, C0960412A, C0970412A, C0980412A, C1030412A, C1040412A, C1050412A, C1060412A, C1061012A, C1070412A, C1071012A, C1081012A, C1101012A, C1111012A, C1120412A, C1121012A, C1130412A, C1131012A, C1140412A, C1141012A, C1160712D, C1440512A, C1450512A, C1460512A, C1470512A, C1510512A, C1520512A, C1530512B, C1540512A, C1550512A, C1560512A, C1570512A, Exp 12/13; e) C0670312A, C0680312A, C0930812B, C0950812C, Exp 12/13; f) C1160712E, Exp 12/13; g) C0950812A, C1110412C, Exp 12/13; h) C0630212B, C0640212B, C0690312A, C0700312A, C0720112B,C0940812A, C0941112A, C0960812A, C1010412B, C1020412B, C1080412A, C1090412A, C1100412A, C1170712A, C1180712A, C1480512A, C1490512A, C1500512A, Exp 12/13; i) C0570212B, C0580212B, C0590212B, C0600212A, C0610212A, C0620212A, C0750312A, C0760312A, C0930812C, C0970812A, C0990412A, C1000412A, Exp 12/13",".","897,379 bottles","Superpotent (Multiple Ingredient) Drug: Complaint received of oversized tablets.",12/6/2012,"12/06/2012",2/6/2013,"02/06/2013"
"Drugs",63819,"Ongoing","Teva Pharmaceuticals USA, Inc.","Sellersville","PA","US","Voluntary: Firm Initiated","Letter","Nationwide","D-249-2013","Class II","Copaxone (glatiramer acetate injection), 20 mg/1 mL, packaged in 30 single use PRE-FILLED syringes and 33 Alcohol Preps (swabs) per box, Marketed by: TEVA Neuroscience, Inc., Kansas City, MO 64131; Distributed by: TEVA Pharmaceuticals USA, Inc., North Wales, PA 19454, NDC 68546-317-30","Lot P53847, Exp 01/14",".","6,692 boxes","Presence of Foreign Substance: Product is being recalled due to receiving an elevated number of patient complaints related to a visible presence of medical grade silicone oil essential to the functionality of the syringe and plunger stopper system.",12/5/2012,"12/05/2012",4/24/2013,"04/24/2013"
"Drugs",63821,"Ongoing","Bayer Healthcare, LLC","Morristown","NJ","US","Voluntary: Firm Initiated","Letter","Nationwide","D-177-2013","Class III","Bronkaid Dual Action Formula, Ephedrine Sulfate 25 mg/Bronchodilator, Guaifenesin 400 mg/Expectorant, a) 24 coated caplets per blister pack, UPC 300240537879, b) 60 coated caplets per blister pack, UPC 300240537855, Bayer HealthCare LLC, Consumer Care, P.O. Box 1910, Morristown, NJ, 07962. ","Lot #s: a) NAA0B3T, NAA0BDB, NAA0B3P, NAA0B3R, NAA0B3N, NAA070E, NAA070F, NAA03PX, NAA03B5, NAA03B6, NAA02LT. b) NAA0TF3, NAA0TF2, NAA0TF0, NAA0TF1, NAA0TET, NAA0TEW, NAA0TEX, NAA0HHL, NAA0HHK, NAA0HHN, NAA0HHH, NAA0DK5, NAA0DK4, NAA0DK3, NAA0CHE, NAA0CHD, NAA0B3L, NAA0B3K, NAA09XE, NAA09XB, NAA07H2, NAA09XD, NAA07H1, NAA09XA, NAA09XC, NAA07H3, NAA07H4, NAA05BB, NAA05BA, NAA07H0, NAA070D, NAA070C, NAA03PW, NAA05B9, NAA070B, NAA03B8, NAA03B7, NAA02N1, NAA02LW, 244511P, 244501P, 244481P, 244471P, 244491P, 244451P.",,"1,353,420 Blister Packs","Labeling: Label lacks warning or Rx legend; Certain information was inadvertently excluded from the product carton label.",12/7/2012,"12/07/2012",3/6/2013,"03/06/2013"
"Devices",63822,"Ongoing","Philips Medical Systems (Cleveland) Inc","Cleveland","OH","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution - USA including AK, AK, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, IL, IN, KS, KY, OA MA, MD MI, MN, MO, MS, NC, D, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI, and WV; Internationally to Canada and other countries..","Z-0880-2013","Class II","Philips Medical Systems, Brilliance Computed Tomography (CT) X-Ray Scanners, Big Bore, Model #728243; and Brilliance Computed Tomography (CT) X-Ray Scanners, Big Bore Oncology, Model #728244.","Brilliance CT Big Bore - Model #728243 - Serial Numbers: 7006, 7007, 7008, 7009, 7013, 7014, 7015, 7016, 7017, 7018, 7019, 7020, 7021, 7022, 7023, 7024, 7025, 7026, 7027, 7028, 7029, 7030, 7031, 7032, 7033, 7034, 7035, 7036, 7037, 7038, 7039, 7040, 7041, 7042, 7043, 7044, 7045, 7046, 7047, 7048, 7049, 7050, 7051, 7053, 7054, 7055, 7056, 7057, 7058, 7059, 7060, 7061, 7062, 7063, 7064, 7065, 7066, 7067, 7068, 7069, 7070, 7071, 7072, 7073, 7074, 7075, 7076, 7077, 7078, 7079, 7080, 7081, 7082, 7083, 7084, 7085, 7086, 7087, 7088, 7089, 7090, 7091, 7092, 7093, 7094, 7095, 7096, 7097, 7098, 7099, 7100, 7101, 7102, 7103, 7104, 7105, 7106, 7107, 7108, 7109, 7110, 7111, 7112, 7113, 7114, 7115, 7116, 7117, 7118, 7119, 7120, 7122, 7123, 7124, 7125, 7126, 7127, 7128, 7129, 7130, 7131, 7132, 7133, 7134, 7135, 7136, 7137, 7138, 7139, 7140, 7141, 7142, 7143, 7144, 7145, 7146, 7147, 7148, 7149, 7150, 7151, 7152, 7153, 7154, 7156, 7157, 7158, 7159, 7160, 7161, 7162, 7163, 7164, 7165, 7166, 7167, 7168, 7169, 7170, 7171, 7173, 7174, 7175, 7177, 7178, 7179, 7181, 7183, 7184, 7185, 7186, 7187, 7188, 7189, 7191, 7192, 7193, 7194, 7195, 7196, 7197, 7198, 7199, 7201, 7202, 7203, 7204, 7205, 7206, 7207, 7208, 7209, 7210, 7211, 7212, 7213, 7214, 7215, 7216, 7217, 7218, 7219, 7220, 7221, 7222, 7223, 7224, 7225, 7226, 7227, 7228, 7229, 7230, 7231, 7232, 7233, 7234, 7235, 7236, 7237, 7238, 7239, 7240, 7241, 7242, 7243, 7245, 7246, 7247, 7248, 7249, 7250, 7251, 7253, 7254, 7255, 7256, 7257, 7258, 7259, 7260, 7261, 7262, 7263, 7265, 7266, 7267, 7269, 7270, 7272, 7273, 7274, 7275, 7276, 7277, 7278, 7279, 7280, 7281, 7282, 7283, 7284, 7285, 7286, 7287, 7288, 7289, 7290, 7291, 7292, 7293, 7294, 7295, 7296, 7297, 7299, 7300, 7302, 7304, 7305, 7306, 7307, 7308, 7309, 7310, 7311, 7312, 7313, 7314, 7315, 7316, 7317, 7319, 7320, 7321, 7322, 7323, 7324, 7325, 7326, 7327, 7328, 7329, 7330, 7331, 7332, 7333, 7334, 7335, 7336, 7337, 7338, 7339, 7340, 7341, 7342, 7343, 7344, 7345, 7346, 7347, 7348, 7349, 7350, 7351, 7352, 7353, 7354, 7355, 7356, 7357, 73",,"765 units","Software anomaly. Philips determined that the TumorLOC software program for the referenced PET/CT X-Ray scanning systems has the capability to generate Intensity Projection data sets from respiratory gated data. A circumstance was identified by the firm whereby these generated datasets are 'flipped' and incorrectly labeled left-to-right when the are saved to disk. If the flipped Intensity Projection data set is used in the radiation therapy workflow, then this may result in unintended delivery of radiation to healthy tissue and/or failure to deliver radiation to the target lesion. ",10/24/2012,"10/24/2012",3/6/2013,"03/06/2013"
"Devices",63822,"Ongoing","Philips Medical Systems (Cleveland) Inc","Cleveland","OH","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution - USA including AK, AK, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, IL, IN, KS, KY, OA MA, MD MI, MN, MO, MS, NC, D, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI, and WV; Internationally to Canada and other countries..","Z-0883-2013","Class II","Philips Medical Systems, GEMINI TF Big Bore, Model #882476, Positron Emission Tomography (PET) and X-Ray Computed Tomography (CT) scanning system, a diagnostic imaging systems for fixed or mobile installations that combines Positron Emission Tomography (PET) and X-ray Computed Tomography (CT) systems.","The affected GEMINI Big Bore system is identified with the following Serial Numbers: 9004, 9005, 9006, 9008 ,9009, 9010, 9011, 9012, 9013, 9014, 9014, 9016, 9017, 9018, 9019, 9020, 9021, 9022, 9023, 9201, 9202, 9203, 9204, 9205, 9205, 9206, 9207, 9208, 9209, 9210, 9213, 9214, 9215, 9216, 9217, 9218, 9219, 9220, and 9221.",,"37","Software anomaly. Philips determined that the TumorLOC software program for the referenced PET/CT X-Ray scanning systems has the capability to generate Intensity Projection data sets from respiratory gated data. A circumstance was identified by the firm whereby these generated datasets are 'flipped' and incorrectly labeled left-to-right when the are saved to disk. If the flipped Intensity Projection data set is used in the radiation therapy workflow, then this may result in unintended delivery of radiation to healthy tissue and/or failure to deliver radiation to the target lesion. ",10/24/2012,"10/24/2012",3/6/2013,"03/06/2013"
"Devices",63822,"Ongoing","Philips Medical Systems (Cleveland) Inc","Cleveland","OH","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution - USA including AK, AK, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, IL, IN, KS, KY, OA MA, MD MI, MN, MO, MS, NC, D, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI, and WV; Internationally to Canada and other countries..","Z-0882-2013","Class II","Philips Medical Systems, GEMINI LXL - Model #882412; GEMINI TF 16 - Model #882470 and Model #882473; GEMINI TF 64 - Model #882471, Positron Emission Tomography (PET) and X-Ray Computed Tomography (CT) scanning systems, diagnostic imaging systems for fixed or mobile installations that combine Positron Emission Tomography (PET) and X-ray Computed Tomography (CT) systems.","The affected GEMINI systems are identified with the following Serial Numbers: GEMINI LXL Model # 882412, Serial Numbers: 14702 and 14707;GEMINI TF 16 Model #882470, Serial Numbers: 7129, 7121, 7123, 7128, 7096, 7133, 7185, 7187, 7226, and 7220; GEMINI TF 16, Model #882473, Serial Numbers: 7150, and and 7237;GEMINI TF 64, Model #882471, Serial Numbers: 7103, 7126, 7132, 7158, 7160, 7164, 7175, 7178, 7179, 7218, 7229, 7221, 7245, 7550, 7255, and 7256. ",,"30 units ","Software anomaly. Philips determined that the TumorLOC software program for the referenced PET/CT X-Ray scanning systems has the capability to generate Intensity Projection data sets from respiratory gated data. A circumstance was identified by the firm whereby these generated datasets are 'flipped' and incorrectly labeled left-to-right when the are saved to disk. If the flipped Intensity Projection data set is used in the radiation therapy workflow, then this may result in unintended delivery of radiation to healthy tissue and/or failure to deliver radiation to the target lesion. ",10/24/2012,"10/24/2012",3/6/2013,"03/06/2013"
"Devices",63822,"Ongoing","Philips Medical Systems (Cleveland) Inc","Cleveland","OH","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution - USA including AK, AK, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, IL, IN, KS, KY, OA MA, MD MI, MN, MO, MS, NC, D, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI, and WV; Internationally to Canada and other countries..","Z-0881-2013","Class II","Philips Medical Systems, Extended Brilliance Workspace (EBW) X-Ray Scanners, Model #728260. A component of the Computed Tomography X-Ray System.","The EBW Serial Numbers subject to software updates are as follows: 8222, 8235, 8270, 8838, 8841, 8862, 9014, 9019, 9127, 10331, 10348, 10402, 10705, 10749, 10827, 11002, 11362, 11365, 11588, 11597, 11652, 11693, 11704, 11724, 11725, 11828, 11857, 11861, 11945, 11949, 11950, 11951, 11952, 11953, 11954, 11955, 11956, 11957, and 11979. ",,"39 units","Software anomaly. Philips determined that the TumorLOC software program for the referenced PET/CT X-Ray scanning systems has the capability to generate Intensity Projection data sets from respiratory gated data. A circumstance was identified by the firm whereby these generated datasets are 'flipped' and incorrectly labeled left-to-right when the are saved to disk. If the flipped Intensity Projection data set is used in the radiation therapy workflow, then this may result in unintended delivery of radiation to healthy tissue and/or failure to deliver radiation to the target lesion. ",10/24/2012,"10/24/2012",3/6/2013,"03/06/2013"
"Devices",63823,"Completed","Linvatec Corp. dba ConMed Linvatec","Largo","FL","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution - USA including California and Internationally to Spain and Korea","Z-0789-2013","Class II","ConMed Linvatec Biomaterials, PopLok bone Punch PKL-35M, 3.5mm Orthopedic manual surgical instrument - Bone Punch","Lot 256058",,"8","ConMed Linvatech recalled one lot of their PopLok bone Punch 3.5mm because the metal shaft diameter is 4.5mm when it should be 3.5mm.",11/15/2012,"11/15/2012",2/13/2013,"02/13/2013"
"Devices",63825,"Ongoing","HemoCue AB","Angelholm",,"SE","Voluntary: Firm Initiated","E-Mail","Distributed in the states of FL, MA, CA, OR, NY, NC, MO, ID, IN, KY, PA, TX, OK, IL, GA, KS, and UT.","Z-0619-2013","Class III","Analyzing system consists of a small and portable analyzer and plastic microcuvettes. The microcuvette contains reagents deposited on its inner walls. The urine sample is drawn into the cavity by capillary action. The filled cuvette is inserted into the device where the contents of the cuvette are mixed through vibration. Within 90 seconds, the immunochemical reaction is completed and the turbidity is measured photometrically at 610 nm. The albumin concentration is proportional to the turbidity. When the end point is reached, the result is displayed in mg/L. The system can be used for the quantitative determination of low levels of albumin in urine for the purpose of screening for, diagnosing, monitoring and to supplement the clinical evidence in the treatment of microalbuminuria.","See serial numbers of affected devices in attachment profided by firm.",".","48 affected analyzers","Incorrect version of Quick Reference Guide (QRG) was delivered with products in shipment made from April1 st 2011 and onwards. In addition, a warranty statement was missing in the analyzer package.",11/7/2012,"11/07/2012",1/9/2013,"01/09/2013"
"Food",63826,"Ongoing","Lifevantage Corp","Sandy","UT","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Sale of products through a network of independent distributors, preferred customers and end consumers in the United States, Japan, Australia and Mexico. Sales also directly to end consumers for personal consumption in Canada. Independent distributors consume the product themselves and in some cases sell the product or provide the product gratis to those potentially interested in LifeVantage. Preferred customers purchase the products on a monthly, auto-ship basis directly from Life Vantage. Other end consumers purchase directly from LifeVantage via the website and are assigned to a distributor.","F-0876-2013","Class II","Protandim is packaged in a 90cc cylindrical blue bottle with a silver cap and contains thirty caplets per bottle. Label has a blue background with multi-colored print and pictorial stating in part:Lifevantage PROTANDIM *the Nrf2 Synergizer Dietary Supplement I 30 Caplets.","Lot # / Expiration Date: 12-0258 / 7/2/2015;12-0259 / 7/3/2015; 12-0292 / 7/9/2015; 12-0294 / 7/11/2015; 12-0295 / 7/12/2015; 12-0304 / 7/18/2015; 12-0306 / 8/16/2015; 12-0307 / 8/17/2015; 12-0373 / 8/21/2015; 12-0382 / 9/21/2015.",".","247,896 bottles","Possible inclusion of small metal fragments embedded within the tablets of Protandim Dietary Supplement.",12/5/2012,"12/05/2012",1/16/2013,"01/16/2013"
"Devices",63827,"Ongoing","Cordis Corporation","Miami Lakes","FL","US","Voluntary: Firm Initiated","Letter","US (nationwide) including the states of AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, IA, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NJ, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, WA, WI, WV and Hawaii.","Z-0740-2013","Class II","Cordis, a Johnson and Johnson Company, ExoSeal(TM) 6F Vascular Closure Device REF cat. No EX500, EX600, and EX700. Used for femoral artery puncture site closure, reducing times to hemostasis and ambulation in patients who have undergone diagnostic or interventional procedures.","Model EX500: Lot #'s: 15410906, 15411659, 15424968, 15429098, 15429879, 15437509, 15437958, 15444208, 15449422, 15453540, 15456567, 15456568, 15462779, 15462780, 15469984, 15479199, 15481341, 15485491, 15489970, 15501955, 15505186, 15578709, 15589368, 15586530, 15602199, 15603369, 15608590, 15610801, 15617548, 15630141, 15630171, 15639388, 15642692, 15648662, 15650923, 15656441, 15664083, 15670351, 15670768. Model EX600: Lot #'s: 15408606, 15409332, 15410622, 15410623, 15426890, 15430798, 15433095, 15433098, 15441594, 15443327, 15446063, 15448005, 15451542, 15452987, 15455770, 15455771, 15459366, 15459367, 15461179, 15461781, 15463296, 15463297, 15464298, 15464299, 15466362, 15472044, 15475128, 15475795, 15479644, 15484135, 15487458, 15491737, 15496311, 15497038, 15500078, 15500709, 15503015, 15504223, 15504224, 15504748, 15506926, 15508012, 15508353, 15508856, 15510541, 15512713, 15518232, 15540529, 15545067, 15548555, 15549324, 15550196, 15550197, 15557284, 15561545, 15561546, 15566744, 15572185, 15573480, 15579468, 15585121, 15587184, 15596793, 15601234, 15601753, 15604477, 15605089, 15609335, 15613282, 15617549, 15625033, 15627316, 15635233, 15637262, 15643624, 15644116, 15644789, 15644790, 15649759, 15663330. Model EX700 Lot #'s: 15466361, 15471271, 15471272, 15476317, 15476743, 15482155, 15483371, 15486224, 15490397, 15535011, 15540530.",".","98,675 units distributed in US.","On 10/29/2012 Cordis Corporation, Miami Lakes, FL initiated a recall of their Cordis ExoSeal (TM) Vascular Closure Device. Affected lots of Cordis ExoSeal (TM) VCD have been sterilized using a process that did not achieve the sterility assurance level that is required by the standards of this class of product. Model Numbers EX500, EX600, and EX700.",10/29/2012,"10/29/2012",2/6/2013,"02/06/2013"
"Food",63828,"Ongoing","Natural Organics","Melville","NY","US","Voluntary: Firm Initiated","Letter","Nationwide and Puerto Rico","F-0860-2013","Class II","Nature's Plus GLUTEN Free SPIRU-TEIN HIGH PROTEIN ENERGY MEAL, S'mores (Flavor), 1.2 OZ. (34g) Packet, Display Box Product No. 95903, Individual Packet Product No. 45905, UPC Code 097467459052. There are 8 foil packets per corrugated display box. --- Serving Size - 1 packet (1.2 oz.).","Lot /Batch Number 1243522, Best By Date 06/2016",".","1,966 individual packets (1.2 oz.)","One lot of 1.2 oz. packets of Spiru-tein High Protein Energy Meal, S'mores flavor, is labeled as ''Gluten Free'' but actually contains gluten. Lot 1243522 of the product with Best Buy Date 06 2016 is being recalled.",12/13/2012,"12/13/2012",1/9/2013,"01/09/2013"
"Devices",63829,"Ongoing","Horiba Instruments, Inc dba Horiba Medical","Irvine","CA","US","Voluntary: Firm Initiated","Letter","Nationwide in the US, including the states of CA, MI, IN, FL, and GA.","Z-0645-2013","Class II","ABX PENTRA ML, Software Versions: V8.0.x and Below; V.9.0.1 and V9.0.2","Lot/Serial# PML0937",".","10 units","Horiba Medical is recalling ABX PENTRA ML because they have confirmed an issue with the ABX PENTRA ML data management and validation system. An incorrect patient result is transmitted to the Laboratory Information System. This result is from a previous run of the same patient that is stored in the ML database. This issue occurs in a very rare sequence of specific events. The affected software versions are Versions 9.0.1, 9.0.2, 8.0x and below.",9/20/2012,"09/20/2012",1/16/2013,"01/16/2013"
"Biologics",63830,"Terminated","Blood Bank Of San Bernardino And Riverside Counties","San Bernardino","CA","US","Voluntary: Firm Initiated","Letter","California","B-0686-13","Class II","Red Blood Cells Leukocytes Reduced","W125612441491; ",,"1","Blood product, collected from a donor considered to be at increased risk for variant Creutzfeldt-Jakob Disease (vCJD), was distributed.",10/22/2012,"10/22/2012",3/20/2013,"03/20/2013"
"Biologics",63831,"Terminated","Aurora Area Blood Bank Dba Heartland Blood Centers","Aurora","IL","US","Voluntary: Firm Initiated","Telephone","Illinois","B-0681-13","Class II","Platelets Pheresis Leukocytes Reduced Irradiated","units W0397126643919 - part 1, W0397126643919 - part 2",".","2 units","Blood products, labeled leukoreduced but which did not meet the requirements for leukoreduced products, were distributed.",9/26/2012,"09/26/2012",3/27/2013,"03/27/2013"
"Biologics",63832,"Terminated","Virginia Blood Services","Richmond","VA","US","Voluntary: Firm Initiated","FAX","Virginia","B-0680-13","Class II","Platelets Pheresis Leukocytes Reduced","W087612049410; ",,"1","Blood product, labeled as leukoreduced without the assurance that it met the criteria for a leukoreduced product, was distributed.",11/29/2012,"11/29/2012",3/20/2013,"03/20/2013"
"Biologics",63833,"Terminated","Aurora Area Blood Bank Dba Heartland Blood Centers","Aurora","IL","US","Voluntary: Firm Initiated","Letter","Indiana","B-0692-13","Class II","Red Blood Cells","W039708027666D ",".","1 unit","Blood product, incorrectly determined to be negative for the Fyb antigen, was distributed.",9/10/2012,"09/10/2012",3/27/2013,"03/27/2013"
"Biologics",63834,"Terminated","Inova Health Care Services, Inova Blood Donor Services","Sterling","VA","US","Voluntary: Firm Initiated","Telephone","Mississippi","B-0704-13","Class III","Red Blood Cells Leukocytes Reduced","W089812604806;",".","1","Blood product, collected from a donor whose hemoglobin was not recorded during donor screening, was distributed.",10/12/2012,"10/12/2012",3/27/2013,"03/27/2013"
"Biologics",63835,"Terminated","Memorial Blood Centers","Saint Paul","MN","US","Voluntary: Firm Initiated","Other","Michigan","B-0685-13","Class III","Red Blood Cells Leukocytes Reduced","W051512089599; ",,"1","Blood product, collected in an expired collection bag, was distributed.",9/21/2012,"09/21/2012",3/20/2013,"03/20/2013"
"Biologics",63836,"Terminated","HCSC-Blood Center","Bethlehem","PA","US","Voluntary: Firm Initiated","Telephone","Pennsylvania","B-0678-13","Class III","Red Blood Cells Leukocytes Reduced Irradiated Washed","W050912082047; W050912079718; W050912067108; ",,"3","Blood Products, washed with 1.6% sodium chloride during deglycerolization, were distributed.",10/24/2012,"10/24/2012",3/20/2013,"03/20/2013"
"Biologics",63836,"Terminated","HCSC-Blood Center","Bethlehem","PA","US","Voluntary: Firm Initiated","Telephone","Pennsylvania","B-0677-13","Class III","Red Blood Cells Washed","W050912080799; W050912079977; ",,"2","Blood Products, washed with 1.6% sodium chloride during deglycerolization, were distributed.",10/24/2012,"10/24/2012",3/20/2013,"03/20/2013"
"Biologics",63837,"Terminated","Memorial Blood Centers","Saint Paul","MN","US","Voluntary: Firm Initiated","Other","Switzerland; Minnesota","B-0710-13","Class II","Red Blood Cells","W051512030854;",".","1","Blood products, collected from a donor who received a tattoo within 12 months of donating, were distributed.",8/29/2012,"08/29/2012",3/27/2013,"03/27/2013"
"Biologics",63837,"Terminated","Memorial Blood Centers","Saint Paul","MN","US","Voluntary: Firm Initiated","Other","Switzerland; Minnesota","B-0709-13","Class II","Blood and Blood Products for Reprocessing","W051512030854;",".","1","Blood products, collected from a donor who received a tattoo within 12 months of donating, were distributed.",8/29/2012,"08/29/2012",3/27/2013,"03/27/2013"
"Devices",63838,"Ongoing","Horiba Instruments, Inc dba Horiba Medical","Irvine","CA","US","Voluntary: Firm Initiated","Letter","Nationwide Distribution including CA, OK, NY, FL, AZ, NY, VA, and TX.","Z-0633-2013","Class II","PENTRA C200, Part Number: A11A01629. The Pentra C200 system is a fully automated chemistry analyzer using colorimetry, turbidmetry and potentiometry technologies. It is mostly dedicated to in vitro diagnostic analyses based on homogeneous samples such as serum, plasma and uring. ","Lot number: 00456-4108 ",".","384 units","Horiba Medical is recalling the ABX PENTRA AST CP because during the AST application validation on the Pentra C200 using an Audit Systems linearity kit, it was determined that two higher values for AST (expected at 800 U/L and 1000 U/L) were recorded at 280 and 199 U/L without alarm.",10/10/2012,"10/10/2012",1/9/2013,"01/09/2013"
"Devices",63838,"Ongoing","Horiba Instruments, Inc dba Horiba Medical","Irvine","CA","US","Voluntary: Firm Initiated","Letter","Nationwide Distribution including CA, OK, NY, FL, AZ, NY, VA, and TX.","Z-0632-2013","Class II","ABX PENTRA AST CP, Part Number: A11A01629. The ABX Pentra AST CP reagent is a diagnostic reagent for quantitative in vitro determination of Aspartate Amino Transferase (AST) in serum or plasma by colorimetry. ","Lot number: 00456-4108",".","66886 units","Horiba Medical is recalling the ABX PENTRA AST CP because during the AST application validation on the Pentra C200 using an Audit Systems linearity kit, it was determined that two higher values for AST (expected at 800 U/L and 1000 U/L) were recorded at 280 and 199 U/L without alarm.",10/10/2012,"10/10/2012",1/9/2013,"01/09/2013"
"Food",63839,"Ongoing","Sugar Flowers Plus","Glendale","CA","US","Voluntary: Firm Initiated","Press Release","Nationwide.","F-0902-2013","Class I","Pastillage (gum paste) Flowers","Rose - Blue UPC code: 8 38437 00004 7",".",,"Sugar Flowers Plus Inc of Glendale, CA is recalling Cake Decors Pastillage (gum paste) Flowers because of the undeclared use of egg white wash as a glue for the inner petals of flowers.",12/7/2012,"12/07/2012",1/23/2013,"01/23/2013"
"Food",63839,"Ongoing","Sugar Flowers Plus","Glendale","CA","US","Voluntary: Firm Initiated","Press Release","Nationwide.","F-0903-2013","Class I","Pastillage (gum paste) Flowers","Cymbidium - W/M UPC Code: 8 38437 00010 8",".",,"Sugar Flowers Plus Inc of Glendale, CA is recalling Cake Decors Pastillage (gum paste) Flowers because of the undeclared use of egg white wash as a glue for the inner petals of flowers.",12/7/2012,"12/07/2012",1/23/2013,"01/23/2013"
"Food",63839,"Ongoing","Sugar Flowers Plus","Glendale","CA","US","Voluntary: Firm Initiated","Press Release","Nationwide.","F-0899-2013","Class I","Pastillage (gum paste) Flowers","Rose - Pink UPC code: 8 38437 00003 0",".",,"Sugar Flowers Plus Inc of Glendale, CA is recalling Cake Decors Pastillage (gum paste) Flowers because of the undeclared use of egg white wash as a glue for the inner petals of flowers.",12/7/2012,"12/07/2012",1/23/2013,"01/23/2013"
"Food",63839,"Ongoing","Sugar Flowers Plus","Glendale","CA","US","Voluntary: Firm Initiated","Press Release","Nationwide.","F-0901-2013","Class I","Pastillage (gum paste) Flowers","Rose - Red UPC code: 8 38437 00002 3",".",,"Sugar Flowers Plus Inc of Glendale, CA is recalling Cake Decors Pastillage (gum paste) Flowers because of the undeclared use of egg white wash as a glue for the inner petals of flowers.",12/7/2012,"12/07/2012",1/23/2013,"01/23/2013"
"Food",63839,"Ongoing","Sugar Flowers Plus","Glendale","CA","US","Voluntary: Firm Initiated","Press Release","Nationwide.","F-0906-2013","Class I","Pastillage (gum paste) Flowers","Gladiolus - P/BUR UPC code: 8 38437 00013 9",".",,"Sugar Flowers Plus Inc of Glendale, CA is recalling Cake Decors Pastillage (gum paste) Flowers because of the undeclared use of egg white wash as a glue for the inner petals of flowers.",12/7/2012,"12/07/2012",1/23/2013,"01/23/2013"
"Food",63839,"Ongoing","Sugar Flowers Plus","Glendale","CA","US","Voluntary: Firm Initiated","Press Release","Nationwide.","F-0904-2013","Class I","Pastillage (gum paste) Flowers","Cattleya - W/P UPC code: 8 38437 00011 5",".",,"Sugar Flowers Plus Inc of Glendale, CA is recalling Cake Decors Pastillage (gum paste) Flowers because of the undeclared use of egg white wash as a glue for the inner petals of flowers.",12/7/2012,"12/07/2012",1/23/2013,"01/23/2013"
"Food",63839,"Ongoing","Sugar Flowers Plus","Glendale","CA","US","Voluntary: Firm Initiated","Press Release","Nationwide.","F-0900-2013","Class I","Pastillage (gum paste) Flowers","Rose - Yellow UPC code: 8 38437 00001 6",".",,"Sugar Flowers Plus Inc of Glendale, CA is recalling Cake Decors Pastillage (gum paste) Flowers because of the undeclared use of egg white wash as a glue for the inner petals of flowers.",12/7/2012,"12/07/2012",1/23/2013,"01/23/2013"
"Food",63839,"Ongoing","Sugar Flowers Plus","Glendale","CA","US","Voluntary: Firm Initiated","Press Release","Nationwide.","F-0905-2013","Class I","Pastillage (gum paste) Flowers","Gladiolus - A/W UPC ocde: 8 38437 00012 2",".",,"Sugar Flowers Plus Inc of Glendale, CA is recalling Cake Decors Pastillage (gum paste) Flowers because of the undeclared use of egg white wash as a glue for the inner petals of flowers.",12/7/2012,"12/07/2012",1/23/2013,"01/23/2013"
"Devices",63842,"Ongoing","Applied Medical Resources Corp","Rancho Santa Margarita","CA","US","Voluntary: Firm Initiated","E-Mail","Worldwide Distribution - USA (nationwide) and France.","Z-0644-2013","Class II","Laparoscope, general&plastic surgery Used for general, abdominal, gynecological and thoracic minimally invasive surgical procedures to establish a path of entry or to gain access through tissue planes and/or potential spaces for endoscopic instruments.","Lot Number: 1179107",".","72 units","Applied Medical is conducting a voluntary recall on a specific lot number of its 12x150mm Kii shielded bladed access systems. This is due to a potential for the blade to remain exposed after shield deployment. Further use of any affected product should cease immediately. The affected model number is CTB71, and the affected lot is 1179107.",11/5/2012,"11/05/2012",1/16/2013,"01/16/2013"
"Food",63843,"Ongoing","Fresh Unlimited Inc","Sidney","OH","US","Voluntary: Firm Initiated","Letter","Product was shipped to the folloiwng states: AL, FL, GA, IL, IN, KY, MI, NC, NY, OH, PA, TN, VA, WI & WV.","F-0896-2013","Class II","Holiday Fruit Delight Kit 5.1875 lbs (2,353g) INGREDIENTS: APPLES***RED GRAPES, STRAWBERRY GLAZE***MARSHMELLOW***WALNUTS, ALLERGENS: WALNUTS (TREE NUTS) BEST USED BY 11/23/12 TC: 13171319 15:42","Use by 11/23/12 ITEM #74707",".","6 cs/5.1875 lb bags","Possible contamination with Listeria monocytogenes.",12/8/2012,"12/08/2012",1/23/2013,"01/23/2013"
"Food",63843,"Ongoing","Fresh Unlimited Inc","Sidney","OH","US","Voluntary: Firm Initiated","Letter","Product was shipped to the folloiwng states: AL, FL, GA, IL, IN, KY, MI, NC, NY, OH, PA, TN, VA, WI & WV.","F-0889-2013","Class II","Celery Stick 2, 80/2 oz clear plastic bag, Item #70648 USED BY: 11/21/12","Use by 11/21/12 Item# 70648",".","68 cs/80/2 oz bags","Possible contamination with Listeria monocytogenes.",12/8/2012,"12/08/2012",1/23/2013,"01/23/2013"
"Food",63843,"Ongoing","Fresh Unlimited Inc","Sidney","OH","US","Voluntary: Firm Initiated","Letter","Product was shipped to the folloiwng states: AL, FL, GA, IL, IN, KY, MI, NC, NY, OH, PA, TN, VA, WI & WV.","F-0892-2013","Class II","Pineapple Chunks 80/2 oz (4.536g) bag Item #71607, BEST USED BY: 11/21/12 TC: 1 217 2359","Use by 11/21/12",".","Item #7160763 cs/80/2 oz bags","Possible contamination with Listeria monocytogenes.",12/8/2012,"12/08/2012",1/23/2013,"01/23/2013"
"Food",63843,"Ongoing","Fresh Unlimited Inc","Sidney","OH","US","Voluntary: Firm Initiated","Letter","Product was shipped to the folloiwng states: AL, FL, GA, IL, IN, KY, MI, NC, NY, OH, PA, TN, VA, WI & WV.","F-0897-2013","Class II","Waldorf Salad Kit 5.19lb (2,345g) bag Item #74802 INGREDIENTS: APPLES***MAYONNAISE***CELERY, WALNUTS CONTAINS: SOYBEAN OIL, EGG, TREE NUTS (WALNUTS) BEST USED BY: 11/23/12 TC: 13171319 15:43","Use by 11/23/12 Item #74802",".","75 cs/5.19 lb bags","Possible contamination with Listeria monocytogenes.",12/8/2012,"12/08/2012",1/23/2013,"01/23/2013"
"Food",63843,"Ongoing","Fresh Unlimited Inc","Sidney","OH","US","Voluntary: Firm Initiated","Letter","Product was shipped to the folloiwng states: AL, FL, GA, IL, IN, KY, MI, NC, NY, OH, PA, TN, VA, WI & WV.","F-0887-2013","Class II","Red Apple Slices 2.4 oz, Item #71746, 20 oz, Item # 71729 14 oz, Item # 71735. Item #71729 is sold under the brand name Sonic UPC 95829 20000. The other two packages are in clear plastic bags.","2 oz Use By 11/30/12 Item #71729, UPC 95829 2000, 2 oz, Use By 12/3/12, Item #71746; & 14 oz, Use By 12/3/12 & 12/6/12 Item # 71735.",".","Item #71729-359 cs/18/2 oz bags, Item #71746-127 cs/24/2 oz bags & Item #71735-127 cs/6/14 oz bags","Possible contamination with Listeria monocytogenes.",12/8/2012,"12/08/2012",1/23/2013,"01/23/2013"
"Food",63843,"Ongoing","Fresh Unlimited Inc","Sidney","OH","US","Voluntary: Firm Initiated","Letter","Product was shipped to the folloiwng states: AL, FL, GA, IL, IN, KY, MI, NC, NY, OH, PA, TN, VA, WI & WV.","F-0893-2013","Class II","Red Apples DICED 3/4 & 5/1# (4,536G) bag Item #71707 Ingredients: Apples (Apples, Calcium Ascorbate), BEST USED BY: 11/25/12 TC: 1 317 2359 15:40 PRODUCT OF: USA","Use by 11/25/12 Item #71707",".","143 cs/5/1 lb bags","Possible contamination with Listeria monocytogenes.",12/8/2012,"12/08/2012",1/23/2013,"01/23/2013"
"Food",63843,"Ongoing","Fresh Unlimited Inc","Sidney","OH","US","Voluntary: Firm Initiated","Letter","Product was shipped to the folloiwng states: AL, FL, GA, IL, IN, KY, MI, NC, NY, OH, PA, TN, VA, WI & WV.","F-0894-2013","Class II","Green Pepper Strips 3/8 & 80/2oz (4,536g) bag Item #73032 BEST USED BY: 11/21/12 TC: 1 317 2359 15:45","Use by 11/21/12 Item #73032",".","22 cs/80/2 oz bags","Possible contamination with Listeria monocytogenes.",12/8/2012,"12/08/2012",1/23/2013,"01/23/2013"
"Food",63843,"Ongoing","Fresh Unlimited Inc","Sidney","OH","US","Voluntary: Firm Initiated","Letter","Product was shipped to the folloiwng states: AL, FL, GA, IL, IN, KY, MI, NC, NY, OH, PA, TN, VA, WI & WV.","F-0888-2013","Class I","Sliced Green Apples READY TO EAT 14 oz Innerlock Bag UPC 95829 20042 Use By: 12/3/12, Item #71736","Item #71736, Use By 12/3/2012 and 12/6/2012",".","291 cs/6/14 oz bags","Possible contamination with Listeria monocytogenes.",12/8/2012,"12/08/2012",1/23/2013,"01/23/2013"
"Food",63843,"Ongoing","Fresh Unlimited Inc","Sidney","OH","US","Voluntary: Firm Initiated","Letter","Product was shipped to the folloiwng states: AL, FL, GA, IL, IN, KY, MI, NC, NY, OH, PA, TN, VA, WI & WV.","F-0895-2013","Class II","Radish Sliced 80/2oz bag Item #74605 BEST USED BY: 11/21/12 TC: 1 317 2359 15:45","Use by 11/21/12",".","2 cs/80/2 oz (4,536g) bags","Possible contamination with Listeria monocytogenes.",12/8/2012,"12/08/2012",1/23/2013,"01/23/2013"
"Food",63843,"Ongoing","Fresh Unlimited Inc","Sidney","OH","US","Voluntary: Firm Initiated","Letter","Product was shipped to the folloiwng states: AL, FL, GA, IL, IN, KY, MI, NC, NY, OH, PA, TN, VA, WI & WV.","F-0898-2013","Class II","SHREDDED BROCCOLI FRUIT SALAD 6.19# (2,807 g) Ingredients: Broccoli, Cauliflower, Apples, Pears, Cole Slaw Dressing***Cranberry***Raisins CONTAINS: Soybean, egg BEST USED BY: 11/23/12 TC: 13171319 15:59***","Use by 11/23/12 Item #74880",".","10 cs/6.19 lb bags","Possible contamination with Listeria monocytogenes.",12/8/2012,"12/08/2012",1/23/2013,"01/23/2013"
"Food",63843,"Ongoing","Fresh Unlimited Inc","Sidney","OH","US","Voluntary: Firm Initiated","Letter","Product was shipped to the folloiwng states: AL, FL, GA, IL, IN, KY, MI, NC, NY, OH, PA, TN, VA, WI & WV.","F-0890-2013","Class II","Carrot coin 1/4 & 80/2oz bag Item #70263 BEST USED BY 11/21/12 TC: 1 317 2359 15:43","Use by 11/21/12 Item# 70263",".","6 cs/80/2 oz bags","Possible contamination with Listeria monocytogenes.",12/8/2012,"12/08/2012",1/23/2013,"01/23/2013"
"Food",63843,"Ongoing","Fresh Unlimited Inc","Sidney","OH","US","Voluntary: Firm Initiated","Letter","Product was shipped to the folloiwng states: AL, FL, GA, IL, IN, KY, MI, NC, NY, OH, PA, TN, VA, WI & WV.","F-0891-2013","Class II","Red Grapes 80/1.5 oz (3,402g) bag Item #71305 BEST USED BY: 11/21/12","Use by 11/21/12 Item #71305",".","6 cs/80/1.5 oz bags","Possible contamination with Listeria monocytogenes.",12/8/2012,"12/08/2012",1/23/2013,"01/23/2013"
"Biologics",63849,"Terminated","Memorial Blood Centers","Saint Paul","MN","US","Voluntary: Firm Initiated","FAX","New Jersey; New York","B-0682-13","Class II","Platelets Pheresis Leukocytes Reduced","W051512125236; W051512125236; ",,"2","Blood products labeled as leukoreduced which did not meet the requirements for leukoreduced products, were distributed.",10/24/2012,"10/24/2012",3/20/2013,"03/20/2013"
"Devices",63850,"Ongoing","Biomet, Inc.","Warsaw","IN","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution -- US (nationwide) including the countries of , Canada, Japan, Argentina, Australia ,Netherlands, Europe and Chile.","Z-0660-2013","Class II","PT113950 PT HYBRID Glenoid Post Regenerex porous titanium construct Sterile R Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented","Part 113950 Lot 093540, 093550,093570,093580,093590,093600,093610,093620,093720, 093730,093740,093760,093770,093780,282590,282600,282620,282630, 282680,282700,282710,489160,489180,489200,489210,489770,489780, 489790,714480,714550,714570,714700,714730,722210,722250,722280, 984770,984780,984790,984800,984810,984820,984830,984840, and 984850",".","1050","Biomet is recalling Part Number PT-113950 PT Hybrid Glenoid Post, following an investigation which identified that the male thread of the post may be oversized. This oversized condition can vary in degree and may lead to the following three events: 1) If the PT Hybrid Glenoid Post is not fully seated into the Hybrid Base and the implant construct is implanted, then a gap of 1-3 mm will be present. 2) If excessive torque is applied to assemble the post into the base, the PT Hybrid Glenoid Post drive tip could break off. 3) The PT Hybrid Glenoid Post may not thread at all into the Hybrid Glenoid Base, which would prevent assembly of the two implant components.",12/6/2012,"12/06/2012",1/16/2013,"01/16/2013"
"Food",63851,"Ongoing","Unilever United States, Inc.","Englewood Cliffs","NJ","US","Voluntary: Firm Initiated","Letter","Nationwide","F-0880-2013","Class II","Knorr Pasta Sides Cheesy Bacon Macaroni Net Wt. 3.8 oz, (107 g) Unilever Englewood Cliffs, NJ 07632 USA Made in Canada from domestic and imported ingredients Case SCC 10041000082488 UPC 4100008248","Sept1113BUO Sept1213BUO",".","16,500 puches","Knorr Pasta Sides Cheesy Bacon Macaroni may contain soy as a different product mix was inadvertently packaged in the Cheesy Bacon Macaroni pouch.",12/7/2012,"12/07/2012",1/23/2013,"01/23/2013"
"Devices",63852,"Ongoing","Siemens Healthcare Diagnostics","Tarrytown","NY","US","Voluntary: Firm Initiated","E-Mail","Worldwide Distribution - USA including CA, GA, IL, IN, MI, MN, NY, and Puerto Rico. Internationally to Agentina, Bolivia, Brazil, Canada, Chile, Guatemala, South Korea, Philippines, Paraguay, Taiwan, and Uraguay,","Z-0647-2013","Class III","Immunoradiometric assay.","Lots 831 and 832",".","Lot 831=19 units (all foreign consignees) and Lot 832=2 units (all foreign consignees)","The recall was initiated because Siemens Healthcare Diagnostics confirmed an under-recovery of dose values with some vials of Coat-A-Consta (CAC) IRMA TSH calibrators TSI4 (level B), TSI5 (level C), TSI6 (level D), TSI8 (level F), and TSI9 (level G) lot 035. The affected calibrator vials can be identified by a darker yellow color than normal. The TSI3 (level A), TSI7 (level E), and TSIX (level H) lot 035 calibrator vials are not affected. The darker yellow calibrator vials yield a 15-20% lower dose values compared to the target values. This may result in out of range (+2 SD) controls.",11/28/2012,"11/28/2012",1/16/2013,"01/16/2013"
"Devices",63852,"Ongoing","Siemens Healthcare Diagnostics","Tarrytown","NY","US","Voluntary: Firm Initiated","E-Mail","Worldwide Distribution - USA including CA, GA, IL, IN, MI, MN, NY, and Puerto Rico. Internationally to Agentina, Bolivia, Brazil, Canada, Chile, Guatemala, South Korea, Philippines, Paraguay, Taiwan, and Uraguay,","Z-0646-2013","Class III","Immunoradiometric assay. Device is an immunoradiometric assay designed for the quantitative measurement of thyroid stimulating hormone (thyrotropin, TSH) in serum. It is intended strictly for in vitro diagnostic. Used as an aid in the assessment of thyroid status.","Lots 969 and 970",".","Lot 969=33 units (29 units foreign) Lot 970=7 units (42 units foreign)","The recall was initiated because Siemens Healthcare Diagnostics confirmed an under-recovery of dose values with some vials of Coat-A-Consta (CAC) IRMA TSH calibrators TSI4 (level B), TSI5 (level C), TSI6 (level D), TSI8 (level F), and TSI9 (level G) lot 035. The affected calibrator vials can be identified by a darker yellow color than normal. The TSI3 (level A), TSI7 (level E), and TSIX (level H) lot 035 calibrator vials are not affected. The darker yellow calibrator vials yield a 15-20% lower dose values compared to the target values. This may result in out of range (+2 SD) controls.",11/28/2012,"11/28/2012",1/16/2013,"01/16/2013"
"Devices",63852,"Ongoing","Siemens Healthcare Diagnostics","Tarrytown","NY","US","Voluntary: Firm Initiated","E-Mail","Worldwide Distribution - USA including CA, GA, IL, IN, MI, MN, NY, and Puerto Rico. Internationally to Agentina, Bolivia, Brazil, Canada, Chile, Guatemala, South Korea, Philippines, Paraguay, Taiwan, and Uraguay,","Z-0648-2013","Class III","Immunoradiometric assay. Device is an immunoradiometric assay designed for the quantitative measurement of thyroid stimulating hormone (thyrotropin, TSH) in serum. It is intended strictly for in vitro diagnostic. Used as an aid in the assessment of thyroid status.","Lots 742 and 743",".","Lot 742= 8 units all foreign consignees) Lot 743=7 units (all foreign consignees)","The recall was initiated because Siemens Healthcare Diagnostics confirmed an under-recovery of dose values with some vials of Coat-A-Consta (CAC) IRMA TSH calibrators TSI4 (level B), TSI5 (level C), TSI6 (level D), TSI8 (level F), and TSI9 (level G) lot 035. The affected calibrator vials can be identified by a darker yellow color than normal. The TSI3 (level A), TSI7 (level E), and TSIX (level H) lot 035 calibrator vials are not affected. The darker yellow calibrator vials yield a 15-20% lower dose values compared to the target values. This may result in out of range (+2 SD) controls.",11/28/2012,"11/28/2012",1/16/2013,"01/16/2013"
"Biologics",63853,"Terminated","American Red Cross Blood Services","Saint Louis","MO","US","Voluntary: Firm Initiated","FAX","MO; GA; IL; TN; TX; KY; AR; CA; France; Saipan; Guam","B-2315-13","Class II","Red Blood Cells (Apheresis) Leukocytes Reduced","011KV59414; 011KV59414",,"2 Units","Blood products, collected from donors, whose suitability to donate was not adequately determined, were distributed.",10/18/2012,"10/18/2012",9/25/2013,"09/25/2013"
"Biologics",63853,"Terminated","American Red Cross Blood Services","Saint Louis","MO","US","Voluntary: Firm Initiated","FAX","MO; GA; IL; TN; TX; KY; AR; CA; France; Saipan; Guam","B-2317-13","Class II","Plasma Frozen","011LE69759; 011KY66463; 011KM56639; 011KY65726; 011KV59969; 011KY63082; 011KY63094; 011KV59981; 011LE71794; 011KY63689; 011KV60728; 011LE72407; 011KY64233; 011LE73137; 011KY64249; 011LE73145; 011KY64257; 011KV57065; 011KV58986; 011LQ02582; 011KV59001; 011KE96885",,"22 Units","Blood products, collected from donors, whose suitability to donate was not adequately determined, were distributed.",10/18/2012,"10/18/2012",9/25/2013,"09/25/2013"
"Biologics",63853,"Terminated","American Red Cross Blood Services","Saint Louis","MO","US","Voluntary: Firm Initiated","FAX","MO; GA; IL; TN; TX; KY; AR; CA; France; Saipan; Guam","B-2316-13","Class II","Red Blood Cells Leukocytes Reduced","011KY66486; 011KY66463; 011LE71292; 011KY66745; 011LE68827; 011LE69759; 011LE70329; 011LE70832; 011LQ02672; 011KY64773; 011KY64845; 011LQ03311; 011KY64848; 011KJ37754; 011KY65293; 011KM56639; 011KY65726; 011KV56889; 011KV59977; 011LE71387; 011KY63082; 011KV59981; 011LE71394; 011KY63094; 011KV60728; 011LE71794; 011KY63689; 011KV61312; 011LE72400; 011KY63701; 011KV62180; 011LE72407; 011KY64233; 011KY62963; 011LE73137; 011KY64249; 011KV57065; 011LE73145; 011KY64257; 011KV58986; 011LF36310; 011KY64269; 011KV59001; 011LQ02582; 011KY64604; 011LQ02646; 011KY64765; 011KV59969; 011KE96885 011LQ03424; 011LQ03491; 011LQ03787; 011LQ04265; 011LQ04536; 011LQ05475; 011LQ05503; 011LQ05946; 011LQ06027; 011LQ06030; 011LQ06076; 011LQ06077; 011LQ06080; 011LZ52645; 011LZ53104; 011LZ53114; 011LZ53485; 011LZ53546; 011P25067",,"68 Units","Blood products, collected from donors, whose suitability to donate was not adequately determined, were distributed.",10/18/2012,"10/18/2012",9/25/2013,"09/25/2013"
"Biologics",63853,"Terminated","American Red Cross Blood Services","Saint Louis","MO","US","Voluntary: Firm Initiated","FAX","MO; GA; IL; TN; TX; KY; AR; CA; France; Saipan; Guam","B-2314-13","Class III","Blood and Blood Products for Reprocessing","011KY66486; 011LE71292; 011KY66745; 011LE68827; 011LE70329; 011LE70832; 011LQ02672; 011KY64773; 011LQ02901; 011LQ03187; 011KY64845; 011LQ03187; 011KY64848; 011KJ37754; 011KY65293; 011KV56889; 011LE71387; 011KV59977; 011LE71394; 011LE72400; 011KY63701; 011KV61312; 011KV62180; 011KY62963; 011LF36310; 011KY64269; 011KY64604; 011LQ02646; 011KY64765;011LQ03311; 011LQ03491; 011LQ03787; 011LQ04265; 011LQ04536; 011LQ05475; 011LQ05503; 011LQ05946; 011LQ06027; 011LQ06030; 011LQ06076; 011LQ06077; 011LQ06080; 011LZ52645; 011LZ53104; 011LZ53114; 011LZ53485; 011LZ53546",,"47 Units","Blood products, collected from donors, whose suitability to donate was not adequately determined, were distributed.",10/18/2012,"10/18/2012",9/25/2013,"09/25/2013"
"Devices",63855,"Ongoing","St Jude Medical Inc","Saint Paul","MN","US","Voluntary: Firm Initiated","Letter","US Distribution only including the states of FL, KY and OK.","Z-0617-2013","Class III","Fast-Cath Transseptal Guiding Introducer, 90, 8F, REF 406586, Length 60 cm, Sterile EO, Rx only, St. Jude Medical, 14901 DeVeau Place, Minnetonka, MN 55343 Indicated for introducing various cardiovascular catheters into the left side of the heart through the interatrial septum.","Model no. 406586 Batch no. 3619533",".","26","St. Jude Medical is recalling a single batch of Fast Cath Transseptal Guiding Introducers which was packaged as a 180 degree curve style introducer instead of a 90 degree curve style introducer as indicated on the labeling. ",3/28/2012,"03/28/2012",1/9/2013,"01/09/2013"
"Devices",63856,"Ongoing","Integra LifeSciences Corp.","Plainsboro","NJ","US","Voluntary: Firm Initiated","Letter","Distributed in the states of IL, ID, LA, MA, NJ, NY, OH, PA, and SD.","Z-1103-2013","Class II","Integra XKnife Stereotactic Radiosurgery and Radiotherapy Treatment Planning, Software Versions 5.0.1 and 5.0.2. Intended for use in stereotactic and non-stereotactic (frameless stereotactic), collimated beam, computer planned, linear accelerator (Linac) based treatment.","Software Versions 5.0.1 and 5.0.2.",".","11 XKnife V5.0.1 and 1 XKnife V5.0.2","Depending on the system configuration, a software error message in versions 5.0.1 and 5.0.2. occurs if a beam plan is transmitted from XKnife using DICOM-RT. ",12/10/2012,"12/10/2012",4/24/2013,"04/24/2013"
"Devices",63857,"Ongoing","Arjo, Inc. dba ArjoHuntleigh","Addison","IL","US","Voluntary: Firm Initiated","Letter","USA (nationwide) including the states of Alabama, Arkansas, Arizona, California, Colorado, Connecticut, Florida, Georgia, Iowa, Idaho, Illinois, Indiana, Kansas, Kentucky, Maryland, Maine, Michigan, Minnesota, Missouri, Mississippi, Montana, North Dakota, New Jersey, New York, Ohio, Oklahoma, Oregon, Pennsylvania, South Dakota, Tennessee, Texas, Utah, Virginia, Washington, Wisconsin and Wyoming.","Z-0615-2013","Class II","Flowtron Trio DVT Pump; an Rx intermittent pneumatic compression deep vein thrombosis pump; ArjoHuntleigh AB, Eslov, Sweden; Model 512003; a non-invasive prophylaxis system for reducing the incidence of deep vein thrombosis. ","Model 512003, all serial numbers",".","2,859 unts","The Flowtron Trio DVT Pump has been marketed without proper FDA Approval.",12/10/2012,"12/10/2012",1/2/2013,"01/02/2013"
"Devices",63858,"Ongoing","Lumenis Limited","Yokneam",,"IL","Voluntary: Firm Initiated","Letter","Worldwide Distribution - US Nationwide including: CA, WI, NC, FL, PA, IN, NM, NJ, IA, WA, OH, FL, MD, MA, WY, NY, AZ, NH, MN, TN, OK, KY, TX, AK, MI, VT. Internationally: Japan, Nepal, India, UK, South Korea, Netherlands, Germany, Australia, China, Canada, Turkey, Spain, Italy, Egypt, Mexico, Bulgaria, Utd. Arab, Emir., Poland, Kuwait, Hong Kong, Saudi Arabia, Yemen, Qatar, Czech Republic, New Zealand, Malaysia, Portugal, France, Argentina, Singapore, Romania, Chile, Colombia, Switzerland, Bahrain, Brazil, Serbia/Montenero, Taiwan, Israel, Indonesia, Peru, Pakistan, Nepal, Belarus, Latvia, Sri Lanka, Russian Fed, Thailand, Azerbaijan, Belgium, and Denmark.","Z-0795-2013","Class I","The Lumenis VersaCut Tissue Morcellator Product Usage: is intended for use under direct or endoscopic visualization for the morcellation and removal of dissected tissue during pelviscopic, laparoscopic, percutaneous, and open surgical procedures whenever access to the surgical site is limited.","Model Numbers 0637-245-01 (starter kit) and 0636-470-01 (Control Box) which includes all products since initial product release 1998.",,"931 units","Lumenis Ltd is recalling certain models of VersaCut Morcellator devices to perform corrective labeling as a result of three reported events of air embolism secondary to incorrect reversal tubing system hook-up.",1/2/2013,"01/02/2013",2/20/2013,"02/20/2013"
"Devices",63859,"Ongoing","Handicare Accessibility","Allentown","PA","US","Voluntary: Firm Initiated","Letter","Worldwide distribution: USA (Nationwide) and country of: Canada.","Z-0171-2014","Class II","Handset component of the Handicare USA's Minivator Bath Bliss Reclining Bath Lifts (Bath Bliss), Part Number BP300-100/BP300-400RSUS (handset) - Model Numbers BBR0311USAB (blue) and BBR0311USSS (silver) Handset component devices operate the Minivator Bath Bliss Reclining Bath Lift, a non-AC-powered patient lift consisting of a motorized actuator, powered mechanical seating device, temporarily secured in a bath, and used to lift and lower a patient in the vertical or reclining position while bathing.","Handsets shipped with Bath Lifts belonging to the following serial numbers: BH05100001 - BH05129999 and BH06120001 - BH11129999; Handsets shipped as spare parts with the following serial numbers: BS05100001 - BS05129999 and BS06120001 - BS11129999.",".","3301 handsets","Firm became aware that two handsets in the affected batches became inoperable while the user was in the tub.",11/29/2012,"11/29/2012",11/13/2013,"11/13/2013"
"Biologics",63860,"Terminated","St Mary's Hospital and Medical Center, Inc.","Grand Junction","CO","US","Voluntary: Firm Initiated","E-Mail","Colorado","B-0690-13","Class II","Platelets Pheresis Leukocytes Reduced","W056312004293; ",,"1","Blood product, with platelet yield that did not meet the specified minimum requirement, was distributed.",8/20/2012,"08/20/2012",3/20/2013,"03/20/2013"
"Biologics",63861,"Ongoing","Ortho Clinical Diagnostics Inc","Raritan","NJ","US","Voluntary: Firm Initiated","Letter","Nationwide, and France Johnson and Johnson Affiliate","B-0672-13","Class III","Ortho Pipetter Volume Verification Kit Ortho Clinical Diagnostics a Johnson & Johnson Company 1001 US Highway 202, Raritan, NJ 08869 USA 1-800-421-3311 Product Code 937924","Product Code 937924; Lot Number 0007",,"1","Ortho Pipetter Volume Verification Kit, Lot 0007, mislabeled with the incorrect expiration date, was distributed.",9/11/2012,"09/11/2012",2/13/2013,"02/13/2013"
"Devices",63862,"Ongoing","B. Braun Medical, Inc.","Allentown","PA","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution--US (nationwide) including the states of AL, AZ, NC and TN.","Z-0623-2013","Class II","Space Pump Pole Clamps for the Infusomat Space Pump, model number 8713130. The Pole Clamp is an accessory to Space Pumps designed to support 1 to 3 pumps on a pole. ","Model number 8713130 and lot numbers 209, 309, 409, 509, 809, 909, 60939747, 60943679, 60945966, 60948966, 60959578, 60960830, 60962412, 61170378, 5048020067, 5048805107, 5048920117, 5049152127, 5049484028, 5049545028, 5049614028, 5049704038, 5049788048, 5049821048, 5050123058, 5050297068, 5050385078, 5051802039, 5051879039, 5051893059, 5051940049, 5051999049, 5052519099, 5052638099, 5052690109, 5052692109, 5052711109, 5052726119, 5052788119, 5052920119, 5053045129, 5053112010, 5053129129, 5053146010, 5053207010, 5053269020, 5053449020, 5053505030, 5053534040, 5053584030, 5053605040, and 5053645040.",".","13,078","Firm has become aware of the potential for breakage of the pole clamp locking grids, or rasters, in the Space Pole Clamps.",3/23/2012,"03/23/2012",1/9/2013,"01/09/2013"
"Devices",63863,"Ongoing","Stryker Howmedica Osteonics Corp.","Mahwah","NJ","US","Voluntary: Firm Initiated","Letter","Nationwide Distribution, including the states of PA, OH, NY, CA and IL.","Z-0695-2013","Class II","Hoffman LRF Wire Bolt, Catalog number 4933-1-001 through -003.","Catalog number 4933-1-001, Lot number Z02804, Z08348, Z08350, Z12549, Z16753. Catalog number 4933-1-002, Lot number Z08351, Z12554, Z16246, Z16752. Catalog number 4933-1-003 Lot Number Z08349, Z09344, Z12551, Z16996.",".","476 units","Two complaints have been filed where Hoffman LRF Wires have broken during load bearing application by patients.",10/25/2012,"10/25/2012",1/23/2013,"01/23/2013"
"Biologics",63864,"Terminated","Millipore (UK) Ltd.","Livingston",,"GB","Voluntary: Firm Initiated","Letter","NJ","B-0725-13","Class III","Blood Grouping Reagent, Anti-e (Human Monoclonal)(IgM)(For Further Manufacturing Use) EMD Millipore Catalog Number: WD-1L-BK","EMD Millipore Lot Number: WDB1101",,"1 liter ","Single lot of Blood Grouping Reagent For Further Manufacturing Use, with a stability test point failure, was distributed.",11/20/2012,"11/20/2012",2/13/2013,"02/13/2013"
"Food",63865,"Ongoing","General Mills, Inc","Minneapolis","MN","US","Voluntary: Firm Initiated","Letter","AZ, CA, HI, ID, MT, OR, UT, WA GUAM, AMERICAN SAMOA, MEXICO, SINGAPORE, PAPUA NW GUINEA.","F-0936-2013","Class II","Betty Croker, Super Moist Cake Mix, Golden Vanilla, NET WT 15.25 oz (432 g), UPC 0 16000 40993 4, Dist by General Mills Sales, Inc., Minneapolis, MN 55440. Case UPC code 1600040993000","Consumer package code: Better Used By 14SEP2013 Case code: 14SEP3LD",".","6223 cases (12 consumer packages / case)","General Mills is recalling a limited quantity of Betty Crocker SuperMoist Golden Vanilla cake because of a labeling issue. Some product was packaged incorrectly, and contains undeclared FDandC color ingredient not listed on the box's ingredient label. The undeclared colors are: Yellow 5, Yellow 6, Red 40 and Blue 1.",12/10/2012,"12/10/2012",2/6/2013,"02/06/2013"
"Devices",63866,"Ongoing","Alfa Wassermann, Inc.","W Caldwell","NJ","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution - USA (nationwide) and the countries of Canada and Cayman Islands","Z-0743-2013","Class II","Alfa Wassermann System Diluent 750 mL Manufactured for Alfa Wassermann Diagnostic Technologies LLC 4 Henderson Drive West Caldwell, NJ 07006 Alfa Wassermann B.V. Pompmolenlaan 24 3447 GK, Woerden The Netherlands Common name is water solution. Intended to dilute reagents and rinse the parts of a clinical chemistry instrument.","Lot Number 155599 ",".","4,104 kits","Inorganic phosphorus assays using System Diluent Lot 155599 may not product acceptable calibration results.",10/10/2012,"10/10/2012",2/6/2013,"02/06/2013"
"Drugs",63867,"Ongoing","Brower Enterprises Inc","Canton","SD","US","Voluntary: Firm Initiated","Letter","Nationwide and Puerto Rico (through the internet).","D-267-2013","Class I","WOW, Health Enterprises, Dietary Supplement, 30 Caplets, Distributed by: Health Enterprises, 1002 E 5th St., Canton, SD 57013. Manufactured by Riger Natural, S. A. Mexico.","All Lots",".","17,555 Bottles","Marketed without an Approved NDA/ANDA: Brower Enterprises Inc., is recalling its WOW Health Enterprises Dietary Supplement, because it contains undeclared drug ingredients making it an unapproved drug. FDA sample analysis has found the product to contain methocarbamol, dexamethasone, and diclofenac.",12/10/2012,"12/10/2012",5/1/2013,"05/01/2013"
"Devices",63868,"Ongoing","Philips Healthcare Inc.","Andover","MA","US","Voluntary: Firm Initiated","Letter","US Nationwide Distribution including the states of AL, CA, CO, CT, IL, MD, MI, MO, NY, OH, PA","Z-0702-2013","Class II","Juno DRF , X-ray system, diagnostic, Fluoroscopic, general-purpose Model: 70920 Product Usage: Universal R/F, general use ","Serial Numbers: 10110770 11030805 11070848 11070845 11070849 11030806 11090864 11110900 12020982 114087 12030999 12061020 12041003 12061014 12061018 12081040 : ",".","16 units","Values of fluoroscopy time, Air Kerma Rate and Cumulated Air Kerma may not be displayed ''at the fluoroscopist's working position'' as per 21 CFR 1003.21",12/13/2012,"12/13/2012",2/6/2013,"02/06/2013"
"Food",63869,"Ongoing","Nature'S Path Foods Inc","Blaine","WA","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Distributed to CO, CA, CT, FL, GA, HI, IA, IN, NH, OR, PA, TX, and WA.","F-0858-2013","Class II","Hemp Plus Granola. The product is packaged in a 25 lb. container. The UPC is 0 58449 88001 1. The product is labeled in parts: ''***HempPlus Granola***INGREDIENTS: Organic rolled oats, organic evaporated cane juice, organic soybean oil, organic brown rice flour, organic flax seeds, organic hemp seed, organic oat syrup solids (organic oat syrups solids, tocopherol, sea salt, organic molasses***25 lb.***Nature's Path Foods, Blaine, WA 98230***www.naturespath.com***''.","Best Before 2013 June 12; 2013 June 13; 2013 June 14 002 12 261 02:59. This number is explained as: 002: Internal code for Blaine production facility; 12 261: Internal code for year, product manufacturing date based on Julian calendar date (for this case 2012, September 17); 02:59: product packaging time. ",".","2872 cases (25 lb. per case)","Undeclared almond. Vanilla Almond Granola which contains almonds but it was mis-labeled as Hemp Plus Granola and almond was not declared on label.",12/10/2012,"12/10/2012",1/9/2013,"01/09/2013"
"Food",63870,"Ongoing","Taylor Farms Retail, Inc.","Salinas","CA","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","CA and FL","F-0854-2013","Class I","Taylor Farms Hearts of Romaine Lettuce, All Natural, Fresh Hand Selected, Triple Washed and Ready to Enjoy. 10 oz. bags. Taylor Farms, Salinas, CA. UPC 0 30223 04032 3","Code TFRS 332A09; Best By 12-13-12 06:51 B",".","101 cases, 6 x 10 oz packages per case.","Positive IEH sample of Listeria Monocytogenes found in Taylor Farms Hearts of Romaine",12/13/2012,"12/13/2012",1/2/2013,"01/02/2013"
"Drugs",63871,"Ongoing","West-ward Pharmaceutical Corp.","Eatontown","NJ","US","Voluntary: Firm Initiated","Letter","Nationwide and Puerto Rico","D-130-2013","Class II","Lisinopril Tablets, USP 40 mg, packaged in a) 100-count tablets per bottle (NDC 0143-1270-01); b) 1000-count tablets per bottle (NDC 0143-1270-10); Rx only, Manufactured by: West-ward Pharmaceutical Corp., Eatontown, NJ 07724; and c) 1000-count tablets per bottle (NDC 24658-245-10); Rx only, Manufactured for: Blu Pharmaceuticals, Franklin, KY 42134; Manufactured By: West-ward Pharmaceutical Corp., Eatontown, N.J. 07724.","Lot #: a) and b) 69545A, 69546A, 69546B, Exp 10/15; 69547A, Exp 11/15; 69995A, 69999A, 69999B, 70000A, 70001A, 70002A, 70002B, 70003A, 70004A, Exp 02/16; c) 69548A, 69549A, Exp 11/15; 69877A, Exp 02/16",".","32,550 bottles","Presence of Foreign Substance: Uncharacteristic black spots identified as a food grade lubicant with trace amounts of foreign particulates and stainless steel inclusions have been found in the tablets.",12/7/2012,"12/07/2012",1/30/2013,"01/30/2013"
"Drugs",63871,"Ongoing","West-ward Pharmaceutical Corp.","Eatontown","NJ","US","Voluntary: Firm Initiated","Letter","Nationwide and Puerto Rico","D-131-2013","Class II","Propylthiouracil Tablets, USP, 50 mg, packaged in a) 100-count tablets per bottle (NDC 0143-1480-01) and b) 1000-count tablets per bottle (NDC 0143-1480-10), Rx only, Manufactured by: West-ward Pharmaceuticals Corp. Eatontown, NJ 07724.","Lot #: 68478A, 69059A, 69059B, Exp 01/16",".","43,075 bottles","Presence of Foreign Substance: Uncharacteristic spots identified as steel corrosion, degraded tablet material and hydrocarbon oil with trace amounts of iron were found in tablets.",12/7/2012,"12/07/2012",1/30/2013,"01/30/2013"
"Devices",63873,"Ongoing","Ansell Healthcare Products LLC","Dothan","AL","US","Voluntary: Firm Initiated","Letter","Nationwide Distribution.","Z-0717-2013","Class II","LifeStyles Pleasure Collection 30 Premium Lubricated Condoms UPC 0-70907-02625-0. A sheath which covers the penis with a closely fitting membrane. The condom is used for contraceptive and for prophylactic purposes (preventing transmission of sexually transmitted infections).","Ultra Sensitive k9983320 D050329 Flavors and Colors k00408 D046651 Skyn k070800 D046655 Thryll K941258 D046651 Thyn K941258 d046651 Ultra Thin K941258 046651 lot #120921021c",".","445 cases (10680 consumer units)","One lot of LifeStyles Pleasure Collection Lubricated Condoms is misbranded.",11/5/2012,"11/05/2012",1/30/2013,"01/30/2013"
"Devices",63875,"Ongoing","Envoy Medical Corporation","Saint Paul","MN","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution-USA including the states of AL, AZ, CA, CT, FL, GA, IL, MA, MI, MN, NC, OK, RI, and TX, and the country of GERMANY.","Z-0750-2013","Class II","Esteem Programmer Model 6001, US and ISA, Model 3001 Dell E54XX. Part of the Esteem Totally Implantable Hearing System. The ISA and Commander are software packages that run on a laptop personal computer.","Lot# EMC0004011 EMC0004665 EMC0004114 EMC0004356 EMC0004639 EMC0004399 EMC0004922 EMC0004923 EMC0004989 EMC0004126 EMC0004310 EMC0004724 EMC0004967 EMC0004759 EMC0004235 EMC0004929 EMC0004234 EMC0004965 EMC0004932 EMC0004928 EMC0004969 EMC0004930 EMC0004844 EMC0004053 Lot# EMC0003968 EMC0003985 EMC0003935 EMC0004028 EMC0004027 EMC0004376 EMC0004125 EMC0004303 EMC0004196 EMC0003852 EMC0004191 EMC0004286 EMC0004491 EMC0004594 EMC0004757 EMC0004510 Lot# EMC0004304 EMC0004797 Lot# EMC0003827 EMC0004233",".","44","Envoy Medical is conducting a voluntary correction of a limited number of Esteem Programmers, part of the Esteem Totally Implantable Hearing System, to reduce their susceptibility to noise interference.",1/9/2013,"01/09/2013",2/6/2013,"02/06/2013"
"Devices",63877,"Ongoing","Advanced Sterilization Products","Irvine","CA","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution - USA (nationwide) and internationally to the following countries: AR, CO, TW, SI, AU, MX, MY, HU, PH, BE, FR, DE, IE, IT, ES, NO, CH, and GB.","Z-0661-2013","Class II","STERRAD NX Cassettes, P/N 10133. The STERRAD NX sterilizations systems are low-temperature general purpose sterilizers used to sterilize heat and moisture sensitive reusable medical devices. The sterilant used is hydrogen peroxide supplied in cassette form as a separate accessory. The STERRAD NX Cassettes are only used in conjunction with the STERRAD NX Sterilization system.","Lot # 11J037, 11L038, 11J033",".","12,280 units","Advanced Sterilization Products is recalling three lots of STERRAD NX System Cassettes because it does not have adequate data to support the entire duration of the product's labeled shelf-life.",9/20/2012,"09/20/2012",1/16/2013,"01/16/2013"
"Devices",63878,"Ongoing","Maquet Inc.","Wayne","NJ","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution - USA including AR, GA, SC, TX, TN and internationally to France, United Arab Emirates, Australia, Brazil, Canada, Switzerland, China, Germany, Spain, United Kingdom, Italy, Japan, Sweden, Thailand, Turkey, Serbia, and South Africa.","Z-0627-2013","Class II","Maquet Yuno Extension Table Device Maquet GmbH & Co. KG Kehler Strabe 31 Baden-Wuerttemberg 76437 Rastatt,Germany Used to support the lower extremities immediately before during and after surgery. The extension device is mounted to the YUNO operating table. The product may only be operated by medically trained staff within the OR environment.","Class I exempt Device Listing Number A922956",".","63 devices","There is a potential issue with the screw tension of the extension device 1433.62A1 used with the YUNO table.",11/2/2012,"11/02/2012",1/9/2013,"01/09/2013"
"Drugs",63879,"Ongoing","Schering-Plough Products, LLC","Las Piedras","PR","US","Voluntary: Firm Initiated","Letter","Nationwide and Puerto Rico","D-139-2013","Class II","Temodar (temozolomide) Capsule, 20 mg per capsule, 5 capsules per package, For Oral Administration, Rx Only, Cytotoxic, NDC: 0085-1519-02, Schering Corporation, Kenilworth, New Jersey, 07033","Lot: 0NCW005, Exp 02/2013",".","17,169 Packages","Failed Impurities/Degradation Specifications: The recall is being initiated due to an out-of-specification result in the degradation product testing detected during stability monitoring. ",12/12/2012,"12/12/2012",2/6/2013,"02/06/2013"
"Veterinary",63880,"Ongoing","Hospira Inc.","Lake Forest","IL","US","Voluntary: Firm Initiated","Letter","Alabama, Colorado, District of Columbia, Florida, Iowa, Idaho, Illinois, Indiana, Kansas, Louisiana, Minnesota, Missouri, New York, North Carolina, Ohio, Oklahoma, Pennsylvania, Tennessee, Texas and Virginia.","V-119-2013","Class II","Plum A+ Single Channel Infusion Pump with Module for Veterinary Use Only; Hospira, Inc., Lake Forest, IL 60045; list number 60529, module 60530-04","List number 60529, serial numbers 14315003, 14315004, 14315005, 14315008, 14315009, 14315011, 14315012, 14315013, 14315014, 14315015, 14315017, 14315018, 14315019, 14315020, 14315022, 14315023, 14315025, 14315026, 14315027, 14315028, 14315029, 14315030, 14315031, 14315034, 14315035, 14315036, 14315037, 14315038, 14315040, 14315041, 14315043, 14315044, 14315045, 14315046, 14315047, 14315048, 14315049, 14315050, 14315051, 14315052, 14315053, 14315054, 14315055, 14315056, 14315057, 14315058, 14315059, 14315061, 14315062, 14315063, 14315064, 14315066, 14315067, 14315069, 14315070, 14315071, 14315072, 14315073, 14315074, 14315075, 14315076, 14315077, 14315078, 14315079, 14315080, 14315081, 14315082, 14315083, 14315084, 14315085, 14315086, 14315087, 14315088, 14315089, 14315090, 14315091, 14315092, 14315093, 14315094, 14315095, 14315096, 14315097, 14315098, 14315099, 14315100, 14315101, 14315103, 14315104, 14315105, 14315106, 14315109, 14315110, 14315111, 14315112, 14315113, 14315114, 14315116, 14315117, 14315118, 14315119, 14315120, 14315121, 14315123, 14315124, 14315125, 14315126, 14315127, 14315128, 14315129, 14315130, 14315131, 14315132, 14315133, 14315134, 14315135, 14315136, 14315137, 14315138, 14315139, 14315140, 14315141, 14315142, 14315143, 14315145, 14315146, 14315147, 14315148, 14315149, 14315150, 14315151, 14315152, 14315153, 14315154, 14315155, 14315156, 14315157, 14315158, 14315159, 14315160, 14315161, 14315162, 14315163, 14315164, 14315165, 14315166, 14315167, 14315168, 14315169, 14315170, 14315171, 14315172, 14315173, 14315174, 14315175, 14315176, 14315177, 14315178, 14315179, 14315180, 14315181, 14315182, 14315183, 14315184, 14315185, 14315186, 14315187, 14315188, 14315189, 14315190, 14315191, 14315192, 14315193, 14315194, 14315195, 14315196, 14315197, 14315198, 14315199, 14315200, 14315201, 14315202, 14315203, 14315204, 14315205, 14315207, 14315208, 14315209, 14315210, 14315211, 14315212, 14315213, 14315214, 14315215, 14315216, 14315217, 14315218, 14315219, 14315220, 14315221, 14315223, 14315224, 1",".","467 pumps","The volume control knob on some Plum A+ infusers (located on the back of the infuser) may not function as described in the System Operating Manual - the direction for Loud and Quiet may be reversed. The manual indicates a clockwise rotation of the knob decreases the volume; however, on some of the devices the alarm volume increases when the knob is turned clockwise.",12/7/2012,"12/07/2012",1/23/2013,"01/23/2013"
"Veterinary",63882,"Completed","Claudia's Canine Cuisine","Maumelle","AR","US","Voluntary: Firm Initiated","Telephone","Nationwide","V-158-2013","Class III","Dogcandy Holiday Hound Cake 7.5 oz manufactured by Claudia's Canine Cuisine, UPC 692614010041","Best By Date of 08/2015 UPC 692614010041",,"2,988 units","The product has the potential to contain mold.",12/7/2012,"12/07/2012",5/22/2013,"05/22/2013"
"Veterinary",63882,"Completed","Claudia's Canine Cuisine","Maumelle","AR","US","Voluntary: Firm Initiated","Telephone","Nationwide","V-159-2013","Class III","Dogcandy Blueberry Hound Cake 7.5 oz manufactured by Claudia's Canine Cuisine , UPC 692614010058","Best By Date of 08/2015 UPC 692614010058",,"2,880 units","The product has the potential to contain mold.",12/7/2012,"12/07/2012",5/22/2013,"05/22/2013"
"Food",63883,"Ongoing","Meijer Distribution, Inc","Grand Rapids","MI","US","Voluntary: Firm Initiated","E-Mail","199 Meijer stores located in Illinois, Indiana, Kentucky, Michigan, and Ohio may have received product from Meijer distribution centers.","F-0861-2013","Class III","Markets of Meijer 16oz Redskin Peanuts","Lot 07 2234; Sell by date 12/20/2012 Lot 08 2279; Sell by date 1/1712013 Lot 07 2318; Sell by date 5/3/2013 lot 07 2340; Sell by date 5/3/2013 UPC 8-8692619797-6",".","15336 units","Sodium was not correctly stated on the label.",12/11/2012,"12/11/2012",1/16/2013,"01/16/2013"
"Biologics",63885,"Terminated","LifeSouth Community Blood Centers, Inc.","Gainesville","FL","US","Voluntary: Firm Initiated","FAX","Alabama; Georgia","B-0683-13","Class II","Platelets Pheresis Leukocytes Reduced","W115112345094Z; W115112345094Z; W115112345094Z; ",,"3","Blood products, labeled as leukoreduced without the assurance that they met the criteria for leukoreduced products, were distributed.",11/7/2012,"11/07/2012",3/20/2013,"03/20/2013"
"Biologics",63886,"Terminated","LifeSouth Community Blood Centers Inc - Birmingham Region","Birmingham","AL","US","Voluntary: Firm Initiated","FAX","Alabama","B-0689-13","Class II","Platelets Pheresis Leukocytes Reduced","W115112376125F; ",,"1","Blood product, with platelet count below the specified minimum requirement, was distributed.",11/28/2012,"11/28/2012",3/20/2013,"03/20/2013"
"Biologics",63887,"Terminated","LifeSouth Community Blood Centers, Inc.","Dunwoody","GA","US","Voluntary: Firm Initiated","FAX","Georgia","B-0688-13","Class II","Platelets Pheresis Leukocytes Reduced Irradiated","W115112323972Y; ",,"1","Blood product, with platelet count below the specified minimum requirement, was distributed.",10/20/2012,"10/20/2012",3/20/2013,"03/20/2013"
"Biologics",63888,"Terminated","LifeSouth Community Blood Centers Inc","Huntsville","AL","US","Voluntary: Firm Initiated","FAX","Alabama","B-0691-13","Class III","Red Blood Cells Leukocytes Reduced","W1151123080944; ",,"1","Blood product, collected from a donor who reported post donation illness, was distributed. ",10/26/2012,"10/26/2012",3/20/2013,"03/20/2013"
"Biologics",63889,"Terminated","LifeSouth Community Blood Centers Inc - Birmingham Region","Birmingham","AL","US","Voluntary: Firm Initiated","FAX","Alabama","B-0687-13","Class II","Platelets Pheresis Leukocytes Reduced","W115112340698M; ",,"1","Blood product, with platelet count below the specified minimum requirement, was distributed.",11/7/2012,"11/07/2012",3/20/2013,"03/20/2013"
"Biologics",63890,"Terminated","Plasma Biological Services Inc","Memphis","TN","US","Voluntary: Firm Initiated","FAX","California","B-0760-13","Class II","Source Plasma","12MTNB8646; 12MTNB8318; 12MTNB8074; 12MTNB7755; 12MTNB7400; 12MTNB7164; 12MTNB6681;",".","7","Blood products, collected from a donor who received a body piercing within 12 months of donating, were distributed.",11/14/2012,"11/14/2012",3/27/2013,"03/27/2013"
"Drugs",63891,"Completed","Physicians Total Care, Inc.","Tulsa","OK","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","FL, NC, TX, CO, VA, SC, GA, KS, LA, MO","D-222-2013","Class II","PHYSICIANS TOTAL CARE, TETRACYCLINE, 500 mg, 30 CAPSULES, bottle MFG. BY: TEVA PHARMACEUTICALS USA, SELLERSVILLE PA 18960 NDC 54868-0025-09 ","5YLZ EXP 04/13, 5ZCE EXP 04/13, 61TX EXP 04/13, 65YD EXP 07/13, 6COJ EXP 09/13, 4ZT6 EXP 02/12, 58HD EXP 02/12, 5G4L EXP 08/12, 5KBU EXP 10/12, 5M3W EXP 10/12, 5OHI EXP 10/12, 6JHL EXP 01/14, 6HJQ EXP 01/14",,"3660 capsules","Presence of Foreign Substance(s): There is a potential for foreign particulate matter in the API.",2/20/2012,"02/20/2012",4/3/2013,"04/03/2013"
"Drugs",63891,"Completed","Physicians Total Care, Inc.","Tulsa","OK","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","FL, NC, TX, CO, VA, SC, GA, KS, LA, MO","D-221-2013","Class II","PHYSICIANS TOTAL CARE, TETRACYCLINE, 250 mg, 30 CAPSULES, bottle MFG. BY: TEVA PHARMACEUTICALS USA, SELLERSVILLE PA 18960 NDC 54868-0024-08 ","69MO EXP 05/13, 69SH EXP 05/13, 5KXZ EXP 05/12, 5RE1 EXP 05/12",,"1200 capsules","Presence of Foreign Substance(s): There is a potential for foreign particulate matter in the API.",2/20/2012,"02/20/2012",4/3/2013,"04/03/2013"
"Devices",63892,"Ongoing","Siemens Healthcare Diagnostics, Inc.","Newark","DE","US","Voluntary: Firm Initiated","Letter","Distributed in the states of CA, FL, IL, KS, MA, MI, MN, MS, NM, NY, NC, OH, OR, PA, TN, TX, UT, and WA.","Z-0664-2013","Class II","Emit(R) 2000 Phenobarbital Assay (OSR4D229) and Syva(R) Emit(R) Phenobarbital Assay (4D019UL). Homogeneous enzyme immunoassay intended for use in the quantitative analysis of Phenobarbital in human serum or plasma.","Emit(R) 2000 Phenobarbital Assay (OSR4D229) lots 1237 and 1264 and/or Syva(R) Emit(R) Phenobarbital Assay (4D019UL), lots E1, E2, and E3.",".","1979 cartons","Firm has confirmed higher imprecision with the recalled lots on Beckman Coulter AU(R) Systems and the Syva(R) Emit(R) 2000 Phenobarbital (4D019UL) lots E1, E2, and E3 as an application if the AU(R) System is used, the issue may be experienced. Firm has found that within-run imprecision of the recalled lots frequency of outliers that differ from the expected value by 20%. This is an expansion of the recall initiated in July, 2012 to include additional lots.",12/10/2012,"12/10/2012",1/16/2013,"01/16/2013"
"Food",63893,"Completed","Wegmans Food Markets","Rochester","NY","US","Voluntary: Firm Initiated","Telephone","New York, Pennsylvania, New Jersey, Virginia, Maryland, and Massachusetts","F-0915-2013","Class I","Wegmans Organic Spinach & Spring Mix --- Product is packaged in clam shell in two sizes: 5oz and 11oz.","All lot codes sold between October 14, 2012 and November 1, 2012.",".","31,000 lbs","Wegmans has recalled 5 oz. and 11 oz. packages of Organic Spinach and Spring Mix Blend because the product may be contaminated with E. coli O157:H7.",11/1/2012,"11/01/2012",1/30/2013,"01/30/2013"
"Food",63894,"Completed","Productos 2001 Inc.","Hatillo","PR","US","Voluntary: Firm Initiated","Visit","PR Only (retailers at the north side of the Island)","F-1023-2013","Class II","''***Productos 2001**Plantillas para Pastelillos-Empanadillas-Tacos-Cheese Dog y Otros (dough rounds for tacos and turnovers)***18 units***Keep refrigerated***NET WT. 28 oz***''","none",,"3,925 packages (18 units each)","Undeclared allergens: FD&C Yellow #5, Yellow# 6, Red #40.",12/17/2012,"12/17/2012",3/6/2013,"03/06/2013"
"Biologics",63895,"Ongoing","PSS World Medical Shared Services","JACKSONVILLE","FL","US","Voluntary: Firm Initiated","E-Mail","TX, MA, AZ and CA","B-0894-13","Class III","Labeled in part: ***Meningococcal***Groups A, C, Y and W-135***Oligosaccharide***Diphtheria***CRM***197***Conjugate***Vaccine***Menveo(R)***Powder and solvent for injection***NDC 46028-208-01***Rx Only***NOVARTIS***vaccines***Store refrigerated, away from the freezer compartment, at 36 degrees F to 46 degrees F (2 degrees C to 8 degrees C), protect from light***for intramuscular injection, read the package leaflet before use***","PSSWM Item Number 238361 Lot #M10135B Exp 2/18/2013",,"1","Meningococcal Oligosaccharide Diphtheria Conjugate Vaccine, with lack of assurance of proper temperature maintenance during shipment, was distributed. ",8/1/2012,"08/01/2012",2/13/2013,"02/13/2013"
"Devices",63896,"Ongoing","California Medical Laboratories Inc","Costa Mesa","CA","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution - USA including AZ, FL, CA, LA, CO, and MS. Internationally to Canada, Israel, Greece, Hong Kong, India, Ireland, Jordan, Lebanon, Malaysia, Netherlands, Russia, Saudi Arabia, South Africa and Spain.","Z-0650-2013","Class II","Rigid Tip Suction Wand Non sterile bulk devices (S112468N, S120196N, and S120197N) were sold to Terumo UK to be included in a kit under Terumo as manufacturer's name. The Suction Wands are indicated for use to remove excess fluid from the surgical field.","Catalog No: SU-12202NS Lot No: S112468N, S120196N, S120197N",".","S112468N=1000 units, S120196N=1400 units, & S120197N=1200 units","California Medical Laboratories, Inc. has identified an issue with the Rigid Tip Suction Wand. Due to insufficient adhesive application, the distal tip has the potential to come loose from the wand and fall into the patient's chest cavity.",11/2/2012,"11/02/2012",1/16/2013,"01/16/2013"
"Devices",63896,"Ongoing","California Medical Laboratories Inc","Costa Mesa","CA","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution - USA including AZ, FL, CA, LA, CO, and MS. Internationally to Canada, Israel, Greece, Hong Kong, India, Ireland, Jordan, Lebanon, Malaysia, Netherlands, Russia, Saudi Arabia, South Africa and Spain.","Z-0649-2013","Class II","Sterile Rigid Tip Suction Wand The Suction Wands are indicated for use to remove excess fluid from the surgical field.","Catalog No: SU-12202 Lot No: S112462, S111480",".","S112462=995 units & S111480 1430 units","California Medical Laboratories, Inc. has identified an issue with the Rigid Tip Suction Wand. Due to insufficient adhesive application, the distal tip has the potential to come loose from the wand and fall into the patient's chest cavity.",11/2/2012,"11/02/2012",1/16/2013,"01/16/2013"
"Drugs",63899,"Ongoing","Mylan Institutional, Inc. (d.b.a. UDL Laboratories)","Rockford","IL","US","Voluntary: Firm Initiated","Letter","Nationwide","D-166-2013","Class I","Hydrocodone Bitartrate and Acetaminophen Tablets, USP, 10 mg/500 mg; 100 Tablets (5 x 20), 5 cards each containing 20 blistered tablets per carton, Rx only; Manufactured for: Qualitest Pharmaceuticals, Huntsville, AL 35811, Pkg by & Distributed by UDL Laboratories, Inc., Rockford, IL 61103; NDC 51079-254-21.","Lot #: 3037841, 3040859, 3042573, Exp 12/13",".","3,407 cartons","Superpotent (Multiple Ingredient) Drug: Oversized tablets resulting in superpotent assays of both the hydrocodone and acetaminophen components.",12/14/2012,"12/14/2012",2/27/2013,"02/27/2013"
"Biologics",63900,"Terminated","DCI Biologicals Temple Terrace, LLC","Temple Terrace","FL","US","Voluntary: Firm Initiated","FAX","California","B-0757-13","Class III","Source Plasma","TT0297632; TT0302949; TT0305187;",".","3","Blood products, collected from a donor whose donor suitability was not adequately determined, were distributed.",10/30/2012,"10/30/2012",3/27/2013,"03/27/2013"
"Biologics",63901,"Terminated","Community Blood Centers of South Florida, Inc.","Hialeah","FL","US","Voluntary: Firm Initiated","Telephone","Florida; California","B-0752-13","Class II","Red Blood Cells","W036811257066;",".","1","Blood products, collected from a donor whose suitability to donate was not adequately determined, were distributed.",11/16/2012,"11/16/2012",3/27/2013,"03/27/2013"
"Biologics",63901,"Terminated","Community Blood Centers of South Florida, Inc.","Hialeah","FL","US","Voluntary: Firm Initiated","Telephone","Florida; California","B-0753-13","Class II","Cryoprecipitated AHF, Pooled","W036811823806;",".","1","Blood products, collected from a donor whose suitability to donate was not adequately determined, were distributed.",11/16/2012,"11/16/2012",3/27/2013,"03/27/2013"
"Biologics",63901,"Terminated","Community Blood Centers of South Florida, Inc.","Hialeah","FL","US","Voluntary: Firm Initiated","Telephone","Florida; California","B-0754-13","Class III","Blood and Blood Products for Reprocessing","W036811257066;",".","1","Blood products, collected from a donor whose suitability to donate was not adequately determined, were distributed.",11/16/2012,"11/16/2012",3/27/2013,"03/27/2013"
"Biologics",63902,"Terminated","Micro Typing Systems, Inc.","Pompano Beach","FL","US","Voluntary: Firm Initiated","Letter","Nationwide and Canada.","B-0756-13","Class III","MTS Anti-IgG Cards (Catalog # MTS084024)","08071200124; 08071200125; 08071200126; 08071200127; 08071200128; 08071200129; 08071200130; 08071200131; 08071200132; 08071200133; 08071200136; 09061200101; 09061200103",".","13","In-vitro diagnostic test cards, associated with complaints of an incomplete foil seal for specific lots of ID-Micro Typing System Gel Cards, were distributed.",11/5/2012,"11/05/2012",3/27/2013,"03/27/2013"
"Biologics",63902,"Terminated","Micro Typing Systems, Inc.","Pompano Beach","FL","US","Voluntary: Firm Initiated","Letter","Nationwide and Canada.","B-0755-13","Class II","MTS A/B/D Monoclonal and Reverse Grouping Cards (Catalog # MTS080515) and MTS A/B Monoclonal Grouping Cards (Catalog # MTS080017)","06061205703; 07031203730; 07031203732; 07031203734; 07031203735; 07031203736; 09131203702; 09131203706",".","8","In-vitro diagnostic test cards, associated with complaints of an incomplete foil seal for specific lots of ID-Micro Typing System Gel Cards, were distributed.",11/5/2012,"11/05/2012",3/27/2013,"03/27/2013"
"Biologics",63903,"Terminated","Blood Center Hammond Laboratory (the)","Hammond","LA","US","Voluntary: Firm Initiated","Telephone","Louisiana","B-0571-13","Class II","Red Blood Cells","W067112099190;",".","1","Blood products, collected from a donor whose suitability was not adequately determined, were distributed.",10/25/2012,"10/25/2012",3/27/2013,"03/27/2013"
"Biologics",63903,"Terminated","Blood Center Hammond Laboratory (the)","Hammond","LA","US","Voluntary: Firm Initiated","Telephone","Louisiana","B-0572-13","Class II","Fresh Frozen Plasma","W067112099190;",".","1","Blood products, collected from a donor whose suitability was not adequately determined, were distributed.",10/25/2012,"10/25/2012",3/27/2013,"03/27/2013"
"Veterinary",63905,"Ongoing","Western Stockmen's","Caldwell","ID","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Product was distributed in Idaho and Oregon","V-135-2013","Class II","WSI Pride Plus Amprolium Crumble 1.25%, packaged in a 50 lb. bag. The Product code/number is 104636. Tag is tan in color; with the lot number and product number located at the bottom of the tag just above the tag sew line. The product is labeled in parts: ''***WSI Pride Plus Amprolium Crumble 1.25%***For Beef and Dairy Calves***MEDICATED An aid in the prevention and treatment of coccidiosis caused by Eimeria bovis and E. zurnii in calves***ACTIVE DRUG INGREDIENT***Amprolium (Corid) 1.25%***MANUFACTURED BY WESTERN STOCKMEN'S, CALDWELL, ID 83605*** 208-459-0777***''.","Lot No. 340209114-090712 The lot number consists of the first 9 digits, i.e., 340209114 and is a unique identifier. The Product code is the unique code assigned in the firm's database for this named finished feed product. The number 090712 is September 7, 2012. The tag was made on Sept. 7. This date does not reflect the actual date of manufacture necessarily, as tags are produced at the time an order is placed. In this case, the order was placed on Sept. 7th and at that time the tags were made.",,"200 bags (50 lbs. per bag)","WSI Pride-Plus Amprolium Crumble 1.25% was found to be sub-potent for Amprolium. The sample was detected of 0.9758% instead of 1.25% concentration of Amprolium.",12/11/2012,"12/11/2012",2/13/2013,"02/13/2013"
"Drugs",63908,"Ongoing","Upsher Smith Laboratories, Inc.","Maple Grove","MN","US","Voluntary: Firm Initiated","Telephone","FL, NJ.","D-160-2013","Class II","Propranolol Hydrochloride Extended-release Capsules, USP, 80 mg, 100 Capsules, Rx only, Manufactured for Upsher Smith Laboratories, Inc Minneapolis MN 55447 --- NDC 0245-0085-11, UPC 3 0245-0085-11 9","Lot #308198, Expiration Date is 03/2014",,"60 bottles","Failed Dissolution Test Requirements",11/20/2012,"11/20/2012",2/20/2013,"02/20/2013"
"Biologics",63909,"Completed","Pacific Coast Tissue Bank","Los Angeles","CA","US","FDA Mandated","Letter","nationwide and world wide","B-1555-13","Class I","Item 27g","Batch Numbers: 09116",".","152 allografts","Human tissue allografts, processed in a manner that could cause contamination or cross-contamination during processing, as well as the introduction, transmission, or spread of communicable disease through the use of the HCT/P, were distributed. ",11/5/2012,"11/05/2012",6/19/2013,"06/19/2013"
"Biologics",63909,"Completed","Pacific Coast Tissue Bank","Los Angeles","CA","US","FDA Mandated","Letter","nationwide and world wide","B-1546-13","Class I","Item 27f","Batch Numbers: 09104, 09106, 09114, 09115, 10115, 11103, 11117",".","4,146 units","Human tissue allografts, processed in a manner that could cause contamination or cross-contamination during processing, as well as the introduction, transmission, or spread of communicable disease through the use of the HCT/P, were distributed. ",11/5/2012,"11/05/2012",6/19/2013,"06/19/2013"
"Biologics",63909,"Completed","Pacific Coast Tissue Bank","Los Angeles","CA","US","FDA Mandated","Letter","nationwide and world wide","B-1553-13","Class I","Item 80a","Batch Numbers: 091116",".","194 allografts","Human tissue allografts, processed in a manner that could cause contamination or cross-contamination during processing, as well as the introduction, transmission, or spread of communicable disease through the use of the HCT/P, were distributed. ",11/5/2012,"11/05/2012",6/19/2013,"06/19/2013"
"Biologics",63909,"Completed","Pacific Coast Tissue Bank","Los Angeles","CA","US","FDA Mandated","Letter","nationwide and world wide","B-1547-13","Class I","Item 27g","Batch Numbers: 09101, 09104, 09106, 09111, 09114, 09115, 10109, 10115, 11103, 11117, 11118, 12102 ",".","6,896 units","Human tissue allografts, processed in a manner that could cause contamination or cross-contamination during processing, as well as the introduction, transmission, or spread of communicable disease through the use of the HCT/P, were distributed. ",11/5/2012,"11/05/2012",6/19/2013,"06/19/2013"
"Biologics",63909,"Completed","Pacific Coast Tissue Bank","Los Angeles","CA","US","FDA Mandated","Letter","nationwide and world wide","B-1551-13","Class I","Item 80a","Batch Numbers: 09101, 09104, 09106, 09111, 09114, 09115, 10109, 10116",".","3,126 units","Human tissue allografts, processed in a manner that could cause contamination or cross-contamination during processing, as well as the introduction, transmission, or spread of communicable disease through the use of the HCT/P, were distributed. ",11/5/2012,"11/05/2012",6/19/2013,"06/19/2013"
"Biologics",63909,"Completed","Pacific Coast Tissue Bank","Los Angeles","CA","US","FDA Mandated","Letter","nationwide and world wide","B-1550-13","Class I","Item 71","Batch Numbers: 09102, 09105, 09107, 09108, 09109, 09110, 09111, 09112, 09113, 09118, 09121, 10101, 10113",".","2,038 units","Human tissue allografts, processed in a manner that could cause contamination or cross-contamination during processing, as well as the introduction, transmission, or spread of communicable disease through the use of the HCT/P, were distributed. ",11/5/2012,"11/05/2012",6/19/2013,"06/19/2013"
"Biologics",63909,"Completed","Pacific Coast Tissue Bank","Los Angeles","CA","US","FDA Mandated","Letter","nationwide and world wide","B-1549-13","Class I","Item 70","Batch Numbers: 09102, 09105, 09107, 09108, 09110, 09112, 09113, 09118, 10101, 10103, 10104, 10105, 10106, 10107, 10108, 10110, 10112, 10113, 10114, 10116, 10117",".","10,630 units","Human tissue allografts, processed in a manner that could cause contamination or cross-contamination during processing, as well as the introduction, transmission, or spread of communicable disease through the use of the HCT/P, were distributed. ",11/5/2012,"11/05/2012",6/19/2013,"06/19/2013"
"Biologics",63909,"Completed","Pacific Coast Tissue Bank","Los Angeles","CA","US","FDA Mandated","Letter","nationwide and world wide","B-1548-13","Class I","Item 70a","Batch Numbers: 09105, 09107, 09108, 09109, 09111, 09112, 09121, 10101, 10102, 10104, 10107, 10110, 10111, 10112, 10113, 10114, 10117, 10118",".","13,069 units","Human tissue allografts, processed in a manner that could cause contamination or cross-contamination during processing, as well as the introduction, transmission, or spread of communicable disease through the use of the HCT/P, were distributed. ",11/5/2012,"11/05/2012",6/19/2013,"06/19/2013"
"Biologics",63909,"Completed","Pacific Coast Tissue Bank","Los Angeles","CA","US","FDA Mandated","Letter","nationwide and world wide","B-1556-13","Class I","Item 70","Batch Numbers: 09119, 19120",".","1,594 allografts","Human tissue allografts, processed in a manner that could cause contamination or cross-contamination during processing, as well as the introduction, transmission, or spread of communicable disease through the use of the HCT/P, were distributed. ",11/5/2012,"11/05/2012",6/19/2013,"06/19/2013"
"Biologics",63909,"Completed","Pacific Coast Tissue Bank","Los Angeles","CA","US","FDA Mandated","Letter","nationwide and world wide","B-1552-13","Class I","Item 83cx","Batch Numbers: 09109, 09110, 09111",".","264 units","Human tissue allografts, processed in a manner that could cause contamination or cross-contamination during processing, as well as the introduction, transmission, or spread of communicable disease through the use of the HCT/P, were distributed. ",11/5/2012,"11/05/2012",6/19/2013,"06/19/2013"
"Biologics",63909,"Completed","Pacific Coast Tissue Bank","Los Angeles","CA","US","FDA Mandated","Letter","nationwide and world wide","B-1554-13","Class I","Item 27f","Batch Numbers: 09116",".","814 allografts","Human tissue allografts, processed in a manner that could cause contamination or cross-contamination during processing, as well as the introduction, transmission, or spread of communicable disease through the use of the HCT/P, were distributed. ",11/5/2012,"11/05/2012",6/19/2013,"06/19/2013"
"Food",63910,"Ongoing","Ocean Beauty Seafoods, LLC","Seattle","WA","US","Voluntary: Firm Initiated","Telephone","Nationwide to distributors and retailers in AZ, CA, CO, CT, MA, NH, NJ, NY, OR, PA, RI, TX and WA.","F-0914-2013","Class I","Cold-smoked salmon in vacuum plastic that are partially clear and partially colored blue, yellow, white, labeled in part: front panel: ***Lascco BRAND SLICED SMOKED NOVA SALMON NET WT 4 OZ (113g) PERISHABLE. KEEP REFRIGERATED AT 38F OR COLDER. back panel: ***Lascco BRAND SLICED SMOKED NOVA SALMON***0 72840 01751 7***INGREDIENTS: ATLANTIC SALMON (COLOR ADDED), SALT, SUGAR, PRESERVATIVES (SODIUM BENZOATE, SODIUM ERYTHORBATE, SODIUM NITRITE), FD&C YELLOW #5, YELLOW #6, RED #40, BLUE #1, AND NATURAL HARDWOOD SMOKE. DISTRIBUTED BY OCEAN BEAUTY SEAFOODS LLC, SEATTLE, WA 98119 WWW.OCEANBEAUTY.COM FARM RAISED PRODUCT OF CHILE A white stick-on label, affixed to the top left hand corner of the back panel, reads: top line: M228208 middle line left to right: 07 09 285 12 14 09 and bottom line: 10632","Pack Date: 285 UPC: 0 72840 01757 7",".","95 cases - 12/4 ounce packages per case. The press release reported 96 cases distributed, but that was incorrect.","Ocean Beauty Seafood's sample was found positive for Listeria monocytogenes.",12/13/2012,"12/13/2012",1/23/2013,"01/23/2013"
"Food",63910,"Ongoing","Ocean Beauty Seafoods, LLC","Seattle","WA","US","Voluntary: Firm Initiated","Telephone","Nationwide to distributors and retailers in AZ, CA, CO, CT, MA, NH, NJ, NY, OR, PA, RI, TX and WA.","F-0913-2013","Class I","Cold-smoked salmon in vacuum plastic bags that are partially clear and partially colored black, white, gold and pink, labeled in part: front panel: ***NATHAN'S TRADITIONAL DELICATESSEN NOVA SALMON CLASSIC SMOKED***NET WT 3 OZ (85g)*** back panel: ***NATHAN'S TRADITIONAL DELICATESSEN NOVA SALMON CLASSIC SMOKED***This salmon can be frozen for up to 45 days. Thaw under refrigeration. Once opened, keep refrigerated and be sure to enjoy within five days. Keep refrigerated at 38F or below.***0 73030 80368 2***INGREDIENTS: ATLANTIC SALMON (COLOR ADDED), SALT, SUGAR, PRESERVATIVES (SODIUM BENZOATE, SODIUM ERYTHORBATE, SODIUM NITRITE), FD&C YELLOW #5, YELLOW #6, RED #40, BLUE #1, AND NATURAL HARDWOOD SMOKE. DISTRIBUTED BY OCEAN BEAUTY SEAFOODS LLC, SEATTLE, WA 98119 WWW.OCEANBEAUTY.COM FARM RAISED PRODUCT OF CHILE A white stick-on label, affixed to the top left hand corner of the back panel, reads: top line: M228208 middle line left to right: 07 09 285 12 14 09 and bottom line: 10632","Pack Date: 285 UPC: 0 73030 80368 2;",".","272 cases - 12/3 ounce packages per case. The press release had reported 275 cases had been distributed, but that was incorrect.","Ocean Beauty Seafood's sample was found positive for Listeria monocytogenes.",12/13/2012,"12/13/2012",1/23/2013,"01/23/2013"
"Biologics",63911,"Ongoing","Haemonetics Corporation","Braintree","MA","US","Voluntary: Firm Initiated","Letter","Nationwide and Puerto Rico","B-1063-13","Class II","Leukotrap Blood Collection Systems with Flexible Y Connector, labeled as being manufactured by Medsep Corporation, A Subsidiary of Pall Corporation","12092 BLOOD BAG CP2D/AS3 DBL 500 SP; 12193 BLOOD BAG CP2D/AS3 TR500MLSP; 12194 BLOOD BAG CP2D/AS3 QD500MLSP; 12393 RC-PL TRIP CP2D/AS3 SDP; 12394 RC-PL QUAD CP2D/AS3 SDP; 12593 PL TRIP CP2D/AS3 500ML SDP; 12594 PL QUAD CP2D/AS3 500ML SDP; 12692 WBV DBL CP2D/AS3 500ML SDP; 12693 WBV TRIP CP2D/AS3 500ML SDP; 12992 RC2D DBL CP2D/AS-3 500ML SDP; 12993 RC2D TRIP CP2D/AS3 500ML SDP; 12994 RC2D QUAD CP2D/AS3 500 ML SDP; 13092 BLOOD BAG CPDA-1 DBL 500 SP; 13692 WBV DBL CPDA-1 500ML SDP; 13693 WBV TRIP CPDA-1 500ML SDP; 13694 WBV QUAD CPDA-1 500ML SDP; 62692 VWB CP2D/AS3 DBL 500ML SDP; 62693 VWB CP2D/AS3 TRIP 500ML SDP; 62993 RC2D TRIP CP2D/AS3 500ML SDP; 72092 BLOOD BAG CP2D/AS3 DBL 450 SP; 72193 BLOOD BG CP2D/AS3 TRP 450ML SP; 72292 RC DBL CP2D/AS3 450ML SDP; 72393 RC-PL TRIP CP2D/AS3 SDP; 72663 VWB,CP2D/AS-3 TRIPLE 450ML SDP; 72663 QVWB,CP2D/AS-3 TRIPLE 450ML SDP; 72692 WBV DBL CP2D/AS3 450ML SDP; 72692 RE02699 WBV DBL CP2D/AS3 450ML SDP; 72693 WBV TRIP CP2D/AS3 450ML SDP; 73092 BLOOD BAG CPDA-1 DBL 450ML; 73692 WB V DBL CPDA-1 450 ML SDP; 73694 CDPA-1, 450 ML CAPACITY, QUAD; ATSBC1EB FILTSYSHELEUKO ATS BC PL BL LB; ATSBC1EPSL FILT SYS HELEUKOATSBCPLW/NDL L; ATSBC1ESB FILT SYS HELEUKOATSBCPLW/NDL B; ATSBC1ESN FILT SYS HELEUKOATSBCPLW/NDL N; ATSBC1EU FILTER SYSTEMLEUKOATSBCPLUK LB; ATSBCIESB FILT SYS HELEUKOATSBCPLW/NDL B; BCT0EUPRC BCT0EUPRC - TORNIER EU; BPF4BWL FILT BLOODPROCSET BPF4 LEUKO L; C-PET FILTER HARVEST SET; NFB434CCL T&B QUAD CPD/SAG-M 450 ML; NFB434CCLRE2691 T&B QUAD CPD/SAG-M 450 ML; RC2VAYE F PURECELLRC2F/BLOODW/YSETEULB; RCB434CCL T&T QUAD WB CPD/SAG-M 450ML; RCB434CCL T&T QUAD WB CPD/SAG-M 450ML; RCB434CCLS T&B QUAD RCS CPD/SAG-M 450 ML; RCB434CEL RCT&B4PVCBAG63MLCPD/100MLSAG-M; RCB434CEL3 RCT&B4PVCBAG63MLCPD/100MLSAG-M; RCB434CUP RCT& B4PVCBAGS63MLCPD/100ML SAG; RCB436CCU RED CELL SYSTEM; RCB436CCURE2700 T&B QUAD RC CPD/SAG-M 450 ML; RCB436CCURE2701 T&B QUAD RC CPD/SAG-M 450 ML; RCB436CCURE2721 T&B QUAD RC CPD/SAG-M 450 ML; RCB436CCURE2727 T&B QUAD RC CPD/SAG-M 450 ML; RCB436CCURE27",,"90","Whole Blood Collection Sets, with a potential for a leak to occur in the flexible Y connector of the donor line, were distributed. ",12/6/2012,"12/06/2012",4/17/2013,"04/17/2013"
"Devices",63912,"Ongoing","Abbott Laboratories","Abbott Park","IL","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution -- USA (nationwide) and the countries of Austria, Barbados, Belgium, Canada, China, Colombia, Cyprus, Czech Republic, Denmark, France, Germany, Greece, Hungary, India, Ireland, Italy, Japan, Latvia, Libya, Malaysia, Netherlands, New Zealand, Poland, Portugal, Russia, Saudi Arabia, Serbia, Slovakia, Spain, Sweden, Switzerland, Turkey and United Kingdom.","Z-0698-2013","Class II","ARCHITECT 25-OH Vitamin D Reagent Kit, 03L52-25 (ROW) and 03L52-27 (U.S.) (1 x 100 tests), 03L52-35 (ROW) and 03L52-37 (U.S.) (5 x 100 tests); Abbott Laboratories, Abbott Park, IL 60064 USA, Abbott, Max-Planck-Ring 2, 65205 Wiesbaden, Germany, product of Spain; Product Usage:The ARCHITECT 25-OH Vitamin D assay is a chemiluminescent microparticle immunoassay (CMIA) for the quantitative determination of 25-hydroxyvitamin D (25-OH vitamin D) in human serum and plasma. The ARCHITECT 25-OH Vitamin D assay is to be used as an aid in the assessment of vitamin D sufficiency. ","ARCHITECT 25-OH Vitamin D Reagent Kit list 3L52, lot numbers 02412C000, exp. 12/26/2012; 02512C000, exp. 12/26/2012; 02012G000, exp. 7/16/2013; 01612G000, exp. 7/17/13; 00912G000, exp. 7/10/13; 02512I000, exp. 10/8/2013; 02612I000, exp. 10/8/2013; 03512I000, exp. 10/10/2013; 03712I000, exp. 10/10/13; when used with ARCHITECT Reaction Vessel (RV) list 7C15-01, box lot numbers (bag lot numbers): 19320P100 (6F9891501); 19344P100 (4N5891091); 19404P100 (1J1948151); 19322P100 (LM3891731); 19373P100 (6F9891521); 19407P100 (4N5948361); 19324P100 (NK8891921); 19374P100 (JG7891631); 19408P100 (5P4948471); 19340P100 (1J1890911); 19375P100 (LM3891741); 19497P100 (2L2948281); 19341P100 (2L2891001); 19379P100 (NK8891931); 20026P100 (LM3947841) ",".","28,600 total","The Architect 25-OH Vitamin D assay has the potential to generate falsely elevated or falsely depressed results when used with certain lots of Architect Reaction Vessels.",12/12/2012,"12/12/2012",1/30/2013,"01/30/2013"
"Devices",63915,"Ongoing","SynCardia Systems Inc.","Tucson","AZ","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution -- US (nationwide)","Z-0620-2013","Class II","Companion External Battery, Part Number: 293001-001 The Companion External Battery is a component of the Companion 2 Driver System and the Companion Driver System. Both Driver Systems, with the temporary Total Artificial Heart (TAH-t) are indicated for use as a bridge to transplantation in cardiac transplant-eligible candidates at risk of imminent death from biventricular failure."," Serial # Lot# 00067 11/12 00071 11/12 00073 11/12 00076 11/12 00079 11/12 00085 11/12 00086 11/12 00087 11/12 00089 28/12 00091 28/12 00092 28/12 00093 28/12 00094 28/12 00095 28/12 00098 28/12 00099 28/12 00101 28/12 00102 28/12 00103 28/12 00104 28/12 00105 28/12 00106 28/12 00107 28/12 00108 28/12 00109 28/12 00110 28/12 00111 28/12 00112 28/12 00113 28/12 00114 28/12 00115 28/12 00116 28/12 00117 28/12 00118 28/12 00119 28/12 00120 28/12 00121 28/12 00122 28/12 00123 28/12 00124 28/12 00125 28/12 00126 28/12 00127 28/12 00128 28/12 00129 28/12 00130 28/12 00131 28/12 00132 28/12 00133 28/12 00134 28/12 00135 28/12 00136 28/12 00137 28/12 00138 28/12 00139 28/12 00140 28/12 00141 28/12 00142 28/12 00143 28/12 00144 28/12 00145 28/12 00146 28/12 00147 28/12 00148 28/12 00068 11/12 00069 11/12 00070 11/12 00072 11/12 00075 11/12 00077 11/12 00078 11/12 00080 11/12 00081 11/12 00082 11/12 00083 11/12 00084 11/12 00088 11/12 00090 28/12 00096 28/12 00097 28/12 00100 28/12 ",".","81 units","Syncardia Systems is recalling the Companion External Batteries used with the Companion 2 Driver System because they may potentially be at risk of thermal events and/or other physical damage such as melting, charring and/or burning.",12/5/2012,"12/05/2012",1/9/2013,"01/09/2013"
"Drugs",63916,"Ongoing","Performance Plus Marketing, Inc.","Commerce","CA","US","Voluntary: Firm Initiated","Telephone","Nationwide","D-336-2013","Class I","Mojo nights Capsules, Male Sexual Enhancer, supplied in 1 and 5 count blister packs, Distributed By: Mojo Health, Pompano Beach, FL I count blister UPC - 718122119738; 5 count blister UPC - 705105836430; "," (1 count) Lot# 01MJ0712, (1 count) 01MM0211 Exp: 07/15; (5 count) Lot# 05M0912, Exp: 10/15; ",,"219,000 capsules.","Marketed Without an Approved NDA/ANDA: product may contain undeclared sildenafil, tadalafil and analogues of these FDA approved active ingredients, making them unapproved drugs",12/17/2012,"12/17/2012",5/22/2013,"05/22/2013"
"Drugs",63916,"Ongoing","Performance Plus Marketing, Inc.","Commerce","CA","US","Voluntary: Firm Initiated","Telephone","Nationwide","D-333-2013","Class I","libigrow XXXTREME Capsules, MAXIMUM STRENGTH FORMULA, 1000 mg, supplied in 1, 5 and 10 count blister packs, Distributed By Kretek International, Inc. Moorpark, CA 930210 1 count blister: UPC 705105830735, 5 count blister: UPC 610585435939, 10 count blister: UPC 610585435922.","1 count blister: Lot# 01MNU0912, Exp: 09/15; Lot# 01X0412-1, Exp: 04/15; Lot# 021647, Exp: 12/13, 5 count blister: Lot# 05X0412, Exp: 04/16, 10 count blister: Lot# 10X0412, Exp: 04/16; Lot# 10M0111, Exp: 01/14.",,"686,000 capsules","Marketed Without an Approved NDA/ANDA: product may contain undeclared sildenafil, tadalafil and analogues of these FDA approved active ingredients, making them unapproved drugs",12/17/2012,"12/17/2012",5/22/2013,"05/22/2013"
"Drugs",63916,"Ongoing","Performance Plus Marketing, Inc.","Commerce","CA","US","Voluntary: Firm Initiated","Telephone","Nationwide","D-335-2013","Class I","BLUE Diamond PLATINUM Capsules, 1000 mg, supplied in 1, 5 and 10 count blister packs, Distributed By: DH Distribution Los Angeles, CA 90026 1 count blister UPC -608641933543; 5 count blister UPC - 608641932867; 10 count UPC -608641933536","(1 count)Lot# 01MNU0912, Exp: 08/15, (5 count) Lot# 05BD0712, Exp: 07/15 and 121781, Exp 01/14; (10 count) Lot # 05BD0712, Exp: 07/15",,"1,000 capsules.","Marketed Without an Approved NDA/ANDA: product may contain undeclared sildenafil, tadalafil and analogues of these FDA approved active ingredients, making them unapproved drugs",12/17/2012,"12/17/2012",5/22/2013,"05/22/2013"
"Drugs",63916,"Ongoing","Performance Plus Marketing, Inc.","Commerce","CA","US","Voluntary: Firm Initiated","Telephone","Nationwide","D-334-2013","Class I","BLUE Diamond Pill, supplied in 1, 5 and 10 count blister packs, Male Sexual Enhancement, Distributed By: DH Distribution Los Angeles, CA 90026. 1 count blister: UPC 705105524764, 5 count blister: UPC 736211124012, 10 count blister: UPC 736211123916.","1 count blister: Lot# 01M0412, Exp: 04/15, and Lot#91782, Exp: 01/14. 5 count blister: Lot# 05M0412, Exp: 04/15; 10 count blister: Lot# 10M0412, Exp: 04/15. ",,"213,000 capsules","Marketed Without an Approved NDA/ANDA: product may contain undeclared sildenafil, tadalafil and analogues of these FDA approved active ingredients, making them unapproved drugs",12/17/2012,"12/17/2012",5/22/2013,"05/22/2013"
"Drugs",63916,"Ongoing","Performance Plus Marketing, Inc.","Commerce","CA","US","Voluntary: Firm Initiated","Telephone","Nationwide","D-338-2013","Class I","CASANOVA Capsules, 450 mg, MALE SEXUAL ENHANCER, supplied i n1 count blister packs, UPC 736211906892; Distributed by: Casanova Distributors, Tucker, GA","Lot# 030112, Exp: 03/15",,"96,000 capsules.","Marketed Without an Approved NDA/ANDA: product may contain undeclared sildenafil, tadalafil and analogues of these FDA approved active ingredients, making them unapproved drugs",12/17/2012,"12/17/2012",5/22/2013,"05/22/2013"
"Drugs",63916,"Ongoing","Performance Plus Marketing, Inc.","Commerce","CA","US","Voluntary: Firm Initiated","Telephone","Nationwide","D-337-2013","Class I","Mojo nights SUPREME Capsules, 1000 mg, Male Sexual Enhancer, supplied in 1 count blister packs, UPC 610585435915; Distributed By: Mojo Health, Pompano Beach, FL ","Lot# 01MJS0712, Exp 07/15.",,"70,000 capsules.","Marketed Without an Approved NDA/ANDA: product may contain undeclared sildenafil, tadalafil and analogues of these FDA approved active ingredients, making them unapproved drugs",12/17/2012,"12/17/2012",5/22/2013,"05/22/2013"
"Drugs",63916,"Ongoing","Performance Plus Marketing, Inc.","Commerce","CA","US","Voluntary: Firm Initiated","Telephone","Nationwide","D-332-2013","Class I","libigrow capsules, PERFORMANCE ENHANCER, supplied in 1, 5 and 10 count blister packs, Distributed By: H & K Nutraceuticals Los Angeles, CA 1 count blister: UPC 094922567611, 5 count blister: UPC 094922567628, 10 count blister: UPC 610585434253.","1 count blister: Lot#: 791115, Exp: 12/13; Lot#: 01M0111, Exp: 01/14; Lot#: 01M0212-1, Exp: 02/15; Lot# 01M0212, Exp: 02/15; Lot# 01M0611-2, Exp: 06/14, 5 count blister: Lot# 05M0412, Exp: 04/16, 10 count blister: Lot# 10M0412, Exp: 04/16.",,"610,000 capsules","Marketed Without an Approved NDA/ANDA: product may contain undeclared sildenafil, tadalafil and analogues of these FDA approved active ingredients, making them unapproved drugs",12/17/2012,"12/17/2012",5/22/2013,"05/22/2013"
"Drugs",63917,"Ongoing","Matrixx Initiatives Inc","Scottsdale","AZ","US","Voluntary: Firm Initiated","Press Release","Nationwide.","D-155-2013","Class I","Zicam Extreme Congestion Relief (oxymetazoline HCl) nasal gel, 0.05%, 0.50 fl. oz. (15 mL) spray bottle, Developed and distributed by Zicam LLC, Scottsdale, Arizona 85255, a wholly owned subsidiary of Matrixx Initiatives Inc, NDC 62750-005-10, UPC 7 32216 20410 0.","Lot # 2J23, Exp 09/15",,"46,752 bottles","Microbial Contamination of Non-Sterile Products: Product may be contaminated with Burkholderia cepacia.",12/18/2012,"12/18/2012",2/13/2013,"02/13/2013"
"Devices",63918,"Ongoing","Alere San Diego, Inc.","San Diego","CA","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution - USA (nationwide) Puerto Rico and South Korea.","Z-0747-2013","Class III","Alere Cholestech LDX Calibration Verification, 4 vial set, Catalog Number: 88770 Alere Cholestech LDX Calibration Verification (hereafter referred to as CAL VERS) enables users to monitor the performance of total cholesterol (TC), high density lipoprotein cholesterol (HDL), triglycerides (TRG), and glucose (GLU) test procedures on the Alere Cholestech LDX System. Calibration verification is optional for CLIA waived systems, such as the Alere Cholestech LDX System, under CLIA regulations. However local or state regulations may require that calibration verification is run at regular intervals. ","Lot#271097",".","320 kits","Alere San Diego is recalling the Alere Cholestech LDX Multianalyte Control (MAC) and the Alere Cholestech LDX Calibrator Verification, 4 vial set, because of issues with increased HDL Cholesterol results.",10/22/2012,"10/22/2012",2/6/2013,"02/06/2013"
"Devices",63918,"Ongoing","Alere San Diego, Inc.","San Diego","CA","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution - USA (nationwide) Puerto Rico and South Korea.","Z-0746-2013","Class III","Alere Cholestech LDX Multianalyte Control, 2 vial set, Catalog Number: 88769 Alere Cholestech LDX Multianalyte Control (hereafter referred to as Controls) enables users to monitor the performance of total cholesterol (TC), high density lipoprotein cholesterol (HDL), triglycerides (TRG), glucose (GLU), alanine aminotransferase (ALT), and aspartate aminotransferase (AST) test procedures on the Alere Cholestech LDX System. The results obtained for the controls are to be compared with the assigned values given on the Expected Values Card, accompanying the package insert, to determine if the procedure is within control limits. Assayed quality control material for use with the Alere Cholestech LDX System.","Lot#C2510 and C2510A",".","2,471 kits","Alere San Diego is recalling the Alere Cholestech LDX Multianalyte Control (MAC) and the Alere Cholestech LDX Calibrator Verification, 4 vial set, because of issues with increased HDL Cholesterol results.",10/22/2012,"10/22/2012",2/6/2013,"02/06/2013"
"Biologics",63920,"Terminated","LifeServe Blood Center","Des Moines","IA","US","Voluntary: Firm Initiated","Telephone","Iowa","B-0766-13","Class II","Red Blood Cells (Apheresis) Leukocytes Reduced","W037912178437;",".","1","Blood product, collected from a donor in which donor suitability was not adequately determined, was distributed.",10/26/2012,"10/26/2012",3/27/2013,"03/27/2013"
"Biologics",63921,"Terminated","Inova Health Care Services, Inova Blood Donor Services","Sterling","VA","US","Voluntary: Firm Initiated","Telephone","Maryland; Virginia","B-0777-13","Class III","Platelets Pheresis Leukocytes Reduced Irradiated","W089812008471;",".","1","Blood product, collected from a donor for whom there was no documentation on the donor record of an arm inspection, general appearance of the donor or hemoglobin screening, was distributed.",10/31/2012,"10/31/2012",3/27/2013,"03/27/2013"
"Biologics",63921,"Terminated","Inova Health Care Services, Inova Blood Donor Services","Sterling","VA","US","Voluntary: Firm Initiated","Telephone","Maryland; Virginia","B-0776-13","Class III","Fresh Frozen Plasma (Apheresis)","W089812008471;",".","1","Blood product, collected from a donor for whom there was no documentation on the donor record of an arm inspection, general appearance of the donor or hemoglobin screening, was distributed.",10/31/2012,"10/31/2012",3/27/2013,"03/27/2013"
"Biologics",63922,"Terminated","Indiana Blood Center","Indianapolis","IN","US","Voluntary: Firm Initiated","Telephone","Indiana","B-0765-13","Class II","Red Blood Cells Leukocytes Reduced","W040712234087;",".","1","Blood product, which was collected from a donor who traveled to a malarial endemic area, was distributed.",10/30/2012,"10/30/2012",3/27/2013,"03/27/2013"
"Biologics",63923,"Terminated","Suncoast Communities Blood Bank, Inc.","Sarasota","FL","US","Voluntary: Firm Initiated","E-Mail","Florida","B-0764-13","Class II","Red Blood Cells Leukocytes Reduced","W038612360535;",".","1","Blood product, which was collected from a donor who traveled to a malarial endemic area, was distributed.",11/30/2012,"11/30/2012",3/27/2013,"03/27/2013"
"Biologics",63924,"Terminated","The Blood Alliance, Inc.","Jacksonville","FL","US","Voluntary: Firm Initiated","Telephone","Florida","B-0763-13","Class II","Platelets Pheresis Leukocytes Reduced","W118812517147A; W118812517147B;",".","2","Blood products, which did not meet the acceptable product specifications, were distributed.",11/17/2012,"11/17/2012",3/27/2013,"03/27/2013"
"Biologics",63925,"Terminated","Hoxworth Blood Center UC Medical Center","Cincinnati","OH","US","Voluntary: Firm Initiated","Telephone","Ohio","B-0829-13","Class II","Fresh Frozen Plasma","W037712024689; ",".","1","Blood product, collected from a donor whose health history was not adequately performed, was distributed. ",10/5/2012,"10/05/2012",3/27/2013,"03/27/2013"
"Drugs",63926,"Ongoing","Amedra Pharmaceuticals LLC","Horsham","PA","US","Voluntary: Firm Initiated","Letter","Nationwide and Puerto Rico.","D-171-2013","Class II","Dextroamphetamine Sulfate Extended Release Capsules, 5 mg, 90 capsules, Rx only, Manufactured by Catalent Pharma Solutions for CorePharma, LLC Middlesex, NJ 08846 NDC 64720-327-09","Lot 238316, exp 01/31/2014",,"1,176 bottles","Failed Dissolution Specifications: The affected lots may not meet the specifications for dissolution over the product shelf life. ",12/4/2012,"12/04/2012",3/6/2013,"03/06/2013"
"Drugs",63926,"Ongoing","Amedra Pharmaceuticals LLC","Horsham","PA","US","Voluntary: Firm Initiated","Letter","Nationwide and Puerto Rico.","D-172-2013","Class II","Dextroamphetamine Sulfate Extended Release Capsules, 5 mg, 90 capsules, Rx only, Manufactured by Catalent Pharma Solutions for CorePharma, LLC Middlesex, NJ 08846 NDC 64720-328-09","Lot 220839, exp 11/30/2013",,"12,948 bottles","Failed Dissolution Specifications: The affected lots may not meet the specifications for dissolution over the product shelf life. ",12/4/2012,"12/04/2012",3/6/2013,"03/06/2013"
"Drugs",63926,"Ongoing","Amedra Pharmaceuticals LLC","Horsham","PA","US","Voluntary: Firm Initiated","Letter","Nationwide and Puerto Rico.","D-173-2013","Class II","Dextroamphetamine Sulfate Extended Release Capsules, 5 mg, 90 capsules, Rx only, Manufactured by Catalent Pharma Solutions for CorePharma, LLC Middlesex, NJ 08846 NDC 64720-329-09","Lot 220843, exp 11/30/2013",,"10,968 bottles","Failed Dissolution Specifications: The affected lots may not meet the specifications for dissolution over the product shelf life. ",12/4/2012,"12/04/2012",3/6/2013,"03/06/2013"
"Devices",63927,"Completed","NAImco Inc dba Richmar Inc","Chattanooga","TN","US","Voluntary: Firm Initiated","Letter","Distributed in the states of GA and TN.","Z-0816-2013","Class II","Cloth electrodes with Silver-Carbon construction: P/N 202-9231, Cat No. 400-899, 2 x 2 Electrode, Cloth, AG, All Serial Numbers distributed between 11/01/2009 and 01/31/2010 P/N 202-9241, Cat No. 400-895, 2 Round Electrode, Cloth, AG, All Serial Numbers distributed between 11/01/2009 and 01/31/2010 P/N 202-9381, Cat No. 400-889, 2 x 3.5 Electrode, Cloth AG, All Serial Numbers distributed between 11/01/2009 and 01/31/2010 P/N 202-9501, Cat No. 202-9501, 1.25 Round Electrode, Cloth AG, All Serial Numbers distributed between 11/01/2009 and 01/31/2010 P/N 400-8991, Cat Nos.: 400-877T and 400-899T, 2 x 2.25 Electrode, Cloth, AG, All Serial Numbers distributed between 11/01/2009 and 01/31/2010. Cutaneous electrode.","All Serial Numbers distributed between 11/01/2009 and 01/31/2010",,"25860 electrodes","Electrode Socket Terminal pulling away from the electrode lead wire when the electrical stim lead wire was removed.",11/30/2009,"11/30/2009",2/20/2013,"02/20/2013"
"Devices",63927,"Completed","NAImco Inc dba Richmar Inc","Chattanooga","TN","US","Voluntary: Firm Initiated","Letter","Distributed in the states of GA and TN.","Z-0818-2013","Class II","Foam electrodes with Silver-Carbon construction: P/N 202-9271, Cat No. 400-898, 2 x 2 Electrode, Foam, AG, All Serial Numbers distributed between 11/01/2009 and 01/31/2010 P/N 202-9281, Cat No. 202-9281, 2 Round Electrode, Foam, AG, All Serial Numbers distributed between 11/01/2009 and 01/31/2010 P/N 202-9251, Cat No. 400-893, 3 Round Electrode, Foam AG, All Serial Numbers distributed between 11/01/2009 and 01/31/2010 P/N 202-9291, Cat No. 400-892, 3 Round Electrode, Foam AG, All Serial Numbers distributed between 11/01/2009 and 01/31/2010 P/N 202-9371, Cat No. 400-888, 2 x 3.5 Electrode, Foam AG, All Serial Numbers distributed between 11/01/2009 and 01/31/2010 P/N 202-9491, Cat No. 400-869, 1.25 Round Electrode, Foam AG, All Serial Numbers distributed between 11/01/2009 and 01/31/2010 P/N 202-9511, Cat No. 400-853, 3 x 5 Electrode, Foam AG, All Serial Numbers distributed between 11/01/2009 and 01/31/2010 P/N 300-1541, Cat No. 300-154, 2 x 2.25 Electrode, Foam, AG, All Serial Numbers distributed between 11/01/2009 and 01/31/2010 P/N 300-1561, Cat No. 300-156, 2 Round Electrode, Foam, AG, All Serial Numbers distributed between 11/01/2009 and 01/31/2010 P/N 300-1611, Cat No. 300-161, 4 x 2.25 Electrode, Foam, AG, All Serial Numbers distributed between 11/01/2009 and 01/31/2010, 22818 P/N 300-1631, Cat No. 300-163, 3 Round Electrode, Foam, AG, All Serial Numbers distributed between 11/01/2009 and 01/31/2010 P/N 400-8701, Cat No. 400-870, 2 x 4 Oval Electrode, Foam, AG, All Serial Numbers distributed between 11/01/2009 and 01/31/2010. Cutaneous electrode.","All Serial Numbers distributed between 11/01/2009 and 01/31/2010",,"56980 electrodes","Electrode Socket Terminal pulling away from the electrode lead wire when the electrical stim lead wire was removed.",11/30/2009,"11/30/2009",2/20/2013,"02/20/2013"
"Devices",63927,"Completed","NAImco Inc dba Richmar Inc","Chattanooga","TN","US","Voluntary: Firm Initiated","Letter","Distributed in the states of GA and TN.","Z-0815-2013","Class II","Cloth electrodes with Carbon construction: P/N 201-1231, Cat Nos.: 201-123, 202-454, 203-118, 203-342, 203-454, 203-493, 203-672, 400-877, and 400-877-BJC, 2 x 2 Electrode, Cloth, All Serial Numbers distributed between 11/01/2009 and 01/31/2010 P/N 201-1241, Cat Nos.: 201-124, 202-455, 203-340, 203-674, and 400-872, 2 Round Electrode, Cloth, All Serial Numbers distributed between 11/01/2009 and 01/31/2010 P/N 201-1251, Cat Nos.: 201-138, 202-276, 202-456, 203-336, 203-680, and 400-879, 3 Round Electrode, Cloth, All Serial Numbers distributed between 11/01/2009 and 01/31/2010 P/N 201-1381, Cat Nos.: 201-126, 203-678, and 400-856, 2 x 3.5 Electrode, Cloth, All Serial Numbers distributed between 11/01/2009 and 01/31/2010 P/N 201-1501, Cat Nos.: 201-150 and 400-863, 1.25 Round Electrode, Cloth, All Serial Numbers distributed between 11/01/2009 and 01/31/2010 P/N 201-1521, Cat No. 400-852, 3 x 5 Electrode, Cloth, All Serial Numbers distributed between 11/01/2009 and 01/31/2010 P/N 201-1541, Cat Nos.:201-154 and 400-865 1.5 x 2.5 Oval Electrode, Cloth, All Serial Numbers distributed between 11/01/2009 and 01/31/2010 Cutaneous electrode.","All Serial Numbers distributed between 11/01/2009 and 01/31/2010",,"209860 electrodes","Electrode Socket Terminal pulling away from the electrode lead wire when the electrical stim lead wire was removed.",11/30/2009,"11/30/2009",2/20/2013,"02/20/2013"
"Devices",63927,"Completed","NAImco Inc dba Richmar Inc","Chattanooga","TN","US","Voluntary: Firm Initiated","Letter","Distributed in the states of GA and TN.","Z-0817-2013","Class II","Foam Electrodes with Carbon construction: P/N 201-1261, Cat Nos.: 201-126, 203-678, and 400-856, 1.5 x 3.5 Electrode, Foam, All Serial Numbers distributed between 11/01/2009 and 01/31/2010 P/N 201-1271, Cat Nos.: 201-127, 202-093, 203-483, 203-565, 203-673, and 400-873, 2 x 2 Electrode, Foam, All Serial Numbers distributed between 11/01/2009 and 01/31/2010 P/N 201-1281, Cat Nos.: 201-128, 202-277, 203-675, and 400-873, 2 Round Electrode, Foam, All Serial Numbers distributed between 11/01/2009 and 01/31/2010 P/N 201-1291, Cat Nos.: 201-129, 203-677, and 400-882, 3 Round Electrode, Foam, All Serial Numbers distributed between 11/01/2009 and 01/31/2010 P/N 201-1301, Cat Nos.: 201-130, 203-679, and 400-855, 1.5 x 3.5 Electrode, Foam, All Serial Numbers distributed between 11/01/2009 and 01/31/2010 P/N 201-1371, Cat Nos.: 201-137, 202-278, 203-484, 203-681, and 400-880, 2 x 3.5 Electrode, Foam, All Serial Numbers distributed between 11/01/2009 and 01/31/2010 P/N 202-5671, Cat No. 202-567, 2 x 2 Electrode, Foam, All Serial Numbers distributed between 11/01/2009 and 01/31/2010. Cutaneous electrode.","All Serial Numbers distributed between 11/01/2009 and 01/31/2010",,"129400 electrodes","Electrode Socket Terminal pulling away from the electrode lead wire when the electrical stim lead wire was removed.",11/30/2009,"11/30/2009",2/20/2013,"02/20/2013"
"Food",63928,"Ongoing","Udi's Healthy Foods,Granola & Gluten Free","Denver","CO","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","US Distribution: 5 direct accounts in WA, CA, CO with subaccount distribution to WA, CA, CO, NV, UT, MT, ID, and OR.","F-0864-2013","Class I","Udi's gluten free au naturel granola in 12 ounce clear plastic bag, UPC 6-98997-80615-8, best by 041913 12265 1.","UPC 6-98997-80615-8 Best by 041913 122565 1",".","3510 - 12 ounce bags shipped (585 cases)","Product may contain undeclared almonds.",12/19/2012,"12/19/2012",1/16/2013,"01/16/2013"
"Biologics",63929,"Terminated","Jubilant HollisterStier, LLC","Spokane","WA","US","Voluntary: Firm Initiated","E-Mail","Pennsylvania; Phillipines and Panama.","B-0674-13","Class III","Standardized Mite Allergenic Extract","E1204385",,"1","Standardized Mite Allergenic Extract, mislabeled with the incorrect strength, was distributed.",12/10/2012,"12/10/2012",2/13/2013,"02/13/2013"
"Biologics",63930,"Terminated","Community Blood Center Of Gtr KC","Kansas City","MO","US","Voluntary: Firm Initiated","FAX","Kansas; Florida","B-0831-13","Class II","Cryoprecipitated AHF, Pooled","W045012600486; ",".","1","Blood products, collected from a donor who received a tattoo within 12 months of donating, were distributed.",11/8/2012,"11/08/2012",3/27/2013,"03/27/2013"
"Biologics",63930,"Terminated","Community Blood Center Of Gtr KC","Kansas City","MO","US","Voluntary: Firm Initiated","FAX","Kansas; Florida","B-0830-13","Class II","Red Blood Cells Leukocytes Reduced","W045012026100; ",".","1","Blood products, collected from a donor who received a tattoo within 12 months of donating, were distributed.",11/8/2012,"11/08/2012",3/27/2013,"03/27/2013"
"Devices",63931,"Ongoing","Spacelabs Healthcare, Llc","Issaquah","WA","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution-USA including Puerto Rico and the states of California, Florida, Iowa, Illinois, Louisiana, Michigan, Minnesota, North Carolina, South Carolina, Texas, and Washington, and the countries of Argentina, Mexico, France, and India.","Z-0694-2013","Class II","Spacelabs Smart Disclosure System, Model 92810, is an integrated component of the Intesys Clinical Suite (ICS) G2, Version 4.03. The Smart Disclosure product collects patient waveforms, alarms, vital signs, and 12-lead reports. A 24-hour waveform acquisition is standard, with an upgrade option to 72 hours. The product provides basic trends in both tabular and graphical format, along with a retrospective ECG analysis. The analysis may be defined by patient, and the data may be presented in multiple formats, including a rhythm, a histogram, and a summary view. Standard reports are available from Smart Disclosure, including saved events, disclosure, trends, histogram, and summary. The Spacelabs Smart Disclosure System, Model 92810 is indicated for use in clinical situations where there is a need for review of physiological waveform information and alarm events up to 72 hours after the fact. Smart Disclosure is also indicated in those situations where a retrospective analysis of monitoring patients' ECG waveform data, that can be annotated and edited, is desired. The intended use of the Spacelabs Smart Disclosure is to interface with the Spacelabs monitoring network, providing the user with a means of recalling waveform information and performing retrospective analysis. The most recent 72 hours of monitored patient ECG waveform data can be analyzed, with each analysis limited to 24 hours or less.","ICS G2 Smart Disclosure Model 92810, Version 4.03. There are no serial numbers.",".","17 in US and 6 International","Displaying or printing of an incorrect waveform for the time indicated in the printout or display in the Spacelabs Healthcare Intesys Clinical Suite (ICS) G2, Version 4.03, Clinical Access portion of Smart Disclosure, Model 92810.",12/5/2012,"12/05/2012",1/23/2013,"01/23/2013"
"Food",63932,"Ongoing","Dawn Food Products, Inc.","Jackson","MI","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Distribution Centers in GA, IL, Ca, TX,","F-0862-2013","Class II","Sam's Club Artisan Fresh Miniature Candy Cookie Carton 504 Count , 28.35 lb (12.89 kg)","2 348 18 2 349 18",".","1650 cases","Outer case of Sam's Artisan Fresh Miniature Candy Cookie contained White Chocolate Macadamia Nut Cookie and separate labels matching the White Chocolate Macadamia Nut Cookies.",12/17/2012,"12/17/2012",1/16/2013,"01/16/2013"
"Devices",63933,"Ongoing","Healthtronics, Inc.","Austin","TX","US","Voluntary: Firm Initiated","Letter","CA, CO, FL, GA, NC, NJ, OH, TX, and WI. No international distribution.","Z-0825-2013","Class II","HealthTronics Endocare 3.8mm RenalCryo Cryoprobe, R3.8L, Endocare, Inc., a wholly owned subsidiary of HealthTronics, Inc., 9825 Spectrum Dr. Building 3, Austin, TX 78717 The Endocare CryoProbe is an accessory probe intended for use with the CryoCare Surgical System. The CryoCare Surgical System is intended for use in surgical procedures in the arrears of general surgery, dermatology, neurology, thoracic surgery, pulmonary surgery, ","Lot 10180, Expiration date on box is 2105-07. Model Number R3.8L",".","50 units ","The Endocare 3.8mm RenalCryo Cryoprobe is being recalled because the label on the outer box has the incorrect expiration date. ",12/20/2012,"12/20/2012",2/27/2013,"02/27/2013"
"Devices",63934,"Ongoing","Ortho-Clinical Diagnostics","Rochester","NY","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution, including Nationwide (USA) and the countries of AU, GM, FR, IT, SP, BR, BM, AR, CA, JA, MX, UK, CH, CL, CO, IN, EC, PE, PY, PA, PT, NZ, SG, VE and UY.","Z-0755-2013","Class II","Ortho Clinical Diagnostics VITROS Chemistry Products Vapor Adsorption Cartridge REF/CAT No. 680 0100. VITROS Vapor Adsorption Cartridges are used to remove vapor contaminants that may potentially interfere with Signal Reagent used with MicroWell Assays on the VITROS 3600, VITROS 5600, and VITROS ECi/ECiQ Systems. ","CAT No. 680 0100; the cartridges do not have lot numbers.",".","Domestic: 15,891; Foreign: 5237","Some VITROS Chemistry Products Vapor Adsorption Cartridge CAT No. 6800100 cartons incorrectly contain a Particulate Cartridge Part No. J19612. In some instances, the Particulate Cartridge has been inadvertently installed on the VITROS System instead of the intended VITROS Vapor Adsorption Cartridge which may bias results.",12/13/2012,"12/13/2012",2/6/2013,"02/06/2013"
"Devices",63935,"Ongoing","Leica Microsystems, Inc.","Buffalo Grove","IL","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution - USA (nationwide) and internationally to Australia, Belgium, Brazil, Chile, France, Germany, Ireland, Italy, Japan, Malaysia, Mexico, Netherlands, Philipines, Singapore, South Africa, Spain, Switzerland, Thailand, Turkey, and United Kingdom.","Z-1815-2013","Class II","Leica ASP6025 Vacuum Tissue Processor The Leica ASP6025 is a modular tissue processor for the following laboratory applications: fixation, dehydration, infiltration with intermedium, and the paraffin infiltration of histological tissue specimens.","1) Model ASP6025 120V/50-60 Hz; Serial Numbers: 171, 200, 202, 204, 206, 208, 210, 212, 214, 216, 218, 220, 222, 224, 226, 228, 230, 232, 234, 236, 238, 240, 242, 244, 246, 248, 250, 252, 254, 256, 258, 260, 262, 264, 266, 268, 270, 272, 274, 276, 278, 280, 282, 284, 286, 288, 290, 292, 294; 2) Model ASP6025 230V/50-60 Hz; Serial Numbers: 162, 163, 168, 169, 170, 183, 184, 201, 203, 205, 207, 209, 211, 213, 215, 217, 219, 221, 223, 225, 227, 229, 231, 233, 235, 237, 239, 241, 243, 245, 247, 249, 251, 253, 255, 257, 259, 261, 263, 265, 267, 269, 271, 273, 275, 277, 279, 281, 283, 285, 287, 289, 291, 293, 295, 297, 299, 301, 303, 305, 307, 309, 311, 313, 315, 317, 319, 320, 321, 323, 325, 327, 328, 329, 331, 333, 335, 337, 339 ",,"128 machines","The Instruction for Use 1v9 Ref F and all previous versions specify incorrect dimensions for the Ready To Use (RTU) bottles from other suppliers than Leica. In case of a pressure failure of the device in combination with a bottle with incorrect dimensions, overflow can cause contamination of reagents. Additionally, the current instructions for use does not highlight the importance to check the filling levels of all reagent bottles (RTU and system bottles) prior to every process run. Without this important information, risk of tissue damage or loss is possible. Therefore the missing information will be distributed to all customers by a Field Service Notice.",11/13/2012,"11/13/2012",8/7/2013,"08/07/2013"
"Veterinary",63936,"Ongoing","Dairy Manufacturers, Inc","Prosper","TX","US","Voluntary: Firm Initiated","Telephone","TX","V-136-2013","Class II","Lone Star 22-10-.5 Instant Medicated Calf Milk Replacer 25lb bag, manufactured for Texas Farm Products Company, Nacogdoches, Texas 75963","All product manufactured between January 1, 2012 and December 18, 2012 (lot codes: 202802, 202301, 200902-05, 203204, 203303-05, 206601-02, 206501-05, 209001-04, 211701-03, 215301-05, 219501-05, 224304-06, 223401-03, 229202-04, 234801-05)",,"3,824 bags","Category II drug NeoOxy 100/100 MR used in milk replacer was expired as of December 2011.",12/21/2012,"12/21/2012",2/20/2013,"02/20/2013"
"Food",63937,"Ongoing","Whole Foods Market","Austin","TX","US","Voluntary: Firm Initiated","E-Mail","Domestically, nationwide, and to Canada and the United Kingdom.","F-1531-2013","Class II","Natures Path Hemp Plus Granola sold in bulk bins at Whole Foods PLU 8106","Best by June 12, 13, and 14, 2013",".","411 cases","The product has the potential to contain undeclared almond slices.",12/11/2012,"12/11/2012",6/19/2013,"06/19/2013"
"Devices",63938,"Ongoing","Concentric Medical Inc","Mountain View","CA","US","Voluntary: Firm Initiated","Letter","US (nationwide) including the states of CA, FL, GA, OR and TN.","Z-0655-2013","Class II","FlowGate Balloon Guide Catheter,Manufactured by Concentric Medical, Mountain View, CA. FlowGate Balloon Guide Catheters are coaxial-lumen, braid-reinforced, variable stiffness catheters with a radiopaque marker on the distal end and a bifurcated luer hub on the proximal end. A balloon is flush mounted on the distal end. FlowGate Balloon Guide Catheters are indicated for use in facilitating the insertion and guidance of an intravascular catheter into a selected blood vessel in the peripheral and neurovascular systems. The balloon provides temporary vascular occlusion during these and other angiographic procedures. The Balloon Guide Catheter is also indicated for use as a conduit for Retrieval devices.","Catalog number 90253, lot # 36140; Catalog number 90254, lot numbers 36009, 36135.",".","13 units","Firm received complaints of resistance and possible collapse of the distal tip of the FlowGate Balloon Guide Catheters during use for aspiration.",12/20/2012,"12/20/2012",1/16/2013,"01/16/2013"
"Biologics",63939,"Terminated","Community Blood Center","Dayton","OH","US","Voluntary: Firm Initiated","FAX","Ohio","B-0176-13","Class II","Red Blood Cells Leukocytes Reduced","W035412056646; ",".","1","Blood product, collected from a donor who reported travel to a malarial endemic area, was distributed.",11/20/2012,"11/20/2012",4/10/2013,"04/10/2013"
"Biologics",63940,"Terminated","Community Blood Centers of South Florida, Inc.","Hialeah","FL","US","Voluntary: Firm Initiated","Letter","Michigan; Massachusetts; Florida; Louisiana; New York","B-0843-13","Class II","Cryoprecipitated AHF","8548170; ",".","1","Blood products, collected from a donor whose suitability to donate was not adequately determined, were distributed.",12/6/2012,"12/06/2012",4/10/2013,"04/10/2013"
"Biologics",63940,"Terminated","Community Blood Centers of South Florida, Inc.","Hialeah","FL","US","Voluntary: Firm Initiated","Letter","Michigan; Massachusetts; Florida; Louisiana; New York","B-0844-13","Class II","Plasma Frozen Cryoprecipitated Reduced","8548170; ",".","1","Blood products, collected from a donor whose suitability to donate was not adequately determined, were distributed.",12/6/2012,"12/06/2012",4/10/2013,"04/10/2013"
"Biologics",63940,"Terminated","Community Blood Centers of South Florida, Inc.","Hialeah","FL","US","Voluntary: Firm Initiated","Letter","Michigan; Massachusetts; Florida; Louisiana; New York","B-0846-13","Class II","Fresh Frozen Plasma","2093149; 1506480; 8551762; ",".","3","Blood products, collected from a donor whose suitability to donate was not adequately determined, were distributed.",12/6/2012,"12/06/2012",4/10/2013,"04/10/2013"
"Biologics",63940,"Terminated","Community Blood Centers of South Florida, Inc.","Hialeah","FL","US","Voluntary: Firm Initiated","Letter","Michigan; Massachusetts; Florida; Louisiana; New York","B-0845-13","Class II","Red Blood Cells","8548170; 8551762; ",".","2","Blood products, collected from a donor whose suitability to donate was not adequately determined, were distributed.",12/6/2012,"12/06/2012",4/10/2013,"04/10/2013"
"Biologics",63940,"Terminated","Community Blood Centers of South Florida, Inc.","Hialeah","FL","US","Voluntary: Firm Initiated","Letter","Michigan; Massachusetts; Florida; Louisiana; New York","B-0847-13","Class II","Platelets","8548170; 2093149; 1506480; 8551762; ",".","4","Blood products, collected from a donor whose suitability to donate was not adequately determined, were distributed.",12/6/2012,"12/06/2012",4/10/2013,"04/10/2013"
"Biologics",63940,"Terminated","Community Blood Centers of South Florida, Inc.","Hialeah","FL","US","Voluntary: Firm Initiated","Letter","Michigan; Massachusetts; Florida; Louisiana; New York","B-0842-13","Class II","Red Blood Cells Leukocytes Reduced","2093149; 1506480; ",".","2","Blood products, collected from a donor whose suitability to donate was not adequately determined, were distributed.",12/6/2012,"12/06/2012",4/10/2013,"04/10/2013"
"Devices",63941,"Ongoing","Siemens Healthcare Diagnostics, Inc.","Newark","DE","US","Voluntary: Firm Initiated","Letter","Nationwide Distribution to the following states: AL, AR, CA, CO, FL, GA, IL, IN, KY, MA, MD, MI, MO, NC, NY, OH, PA, TN, TX and WI.","Z-0665-2013","Class III","Siemens Emit(R) tox(TM) Serum Calibrators, catalog number 7B019UL The Emit(R) tox(TM) Serum Calibrators are intended for use with the Emit(R) tox(TM) Serum Barbiturate and Benzodiazepine Assays as a reference for the semi-quantitative analis of barbiturates and benzodiazepines in human serum.","Lot D1",".","1,998 cartons","Incorrect expiration date was assigned to the D1 lot of Emit(R) tox(TM) Serum Calibrators. The correct expiration date is 2013-12-31. The incorrect assigned expiration date is 2014-12-31.",12/6/2012,"12/06/2012",1/16/2013,"01/16/2013"
"Drugs",63942,"Ongoing","P & J Trading Co","Fullerton","CA","US","Voluntary: Firm Initiated","Press Release","Nationwide and Korea","D-165-2013","Class I","SLIMDIA Revolution capsules, 30-count capsules per bottle, Yerba Naturals, 19685 Varda Ave., Buena Park, CA.","There are no manufacturing codes associated with the product.",".","unknown","Marketed Without an Approved NDA/ANDA: All lots of the dietary supplement Slimdia Revolution are being recalled because they contain sibutramine, a previously approved FDA drug removed from the U.S. marketplace for safety reasons, making it an unapproved new drug.",12/19/2012,"12/19/2012",2/27/2013,"02/27/2013"
"Food",63943,"Ongoing","Naturally Fresh Inc.","Atlanta","GA","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","U.S.","F-0885-2013","Class II","Marketside, Chunky Bleu Cheese Dressing, Net Wt. 14 fl. oz (414)mL, Manufactured For Marketside, a division of Wal-Mart Stores, Inc., Bentonville, AR 72716.","Lot code 81H09062; Best By 01/04/13; UPC 6 81131 02900 1",".","978 cases","Undeclared Allergen: Dairy",12/19/2012,"12/19/2012",1/23/2013,"01/23/2013"
"Food",63944,"Ongoing","S & M International Inc","Bayonne","NJ","US","Voluntary: Firm Initiated","Telephone","Northeast","F-0863-2013","Class II","Yangsheng Duck Eggs Cooked Salted Duck Eggs Content:6 pieces Net Wt. 12.69 oz (360g)S & M (USA0 ENTERPRISE CORP. RED. B/T YUOXIU Bldg. 160-174 Lockhart Road, Man Chai, HK Distributed by: S & M INT'L. INC 100 Pulaski Street, Bayonne NJ 07002 UPC 6949682803568","Lot #YS12-02C",".","200 CASES (24 individual packages of 6 eggs each)","Cooked Salted Duck Eggs have the potential to be contaminated with C. botulinum.",12/11/2012,"12/11/2012",1/16/2013,"01/16/2013"
"Devices",63945,"Ongoing","Abbott Laboratories, Inc","Irving","TX","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution - USA (nationwide) and Internationally to Internationally distributed to Argentina, Australia, Austria, Bahamas, Brunei, Canada, Chile, Curacao, Denmark, France, Germany, Greece, Ireland, Italy, Lebanon, Mexico, Netherlands, Norway, Oman, Paraguay, Portugal, Puerto Rico, Russia, Saudi Arabia, Serbia, South Korea, Spain, Switzerland, Turkey, and United Kingdom.","Z-1118-2013","Class II","Clinical Chemistry Phenobarbital, list number 1E08","Lot Numbers 52803UN12, 62299UN12, and 85773UN12",".","1289","Abbott Diagnostics is recalling Clinical Chemistry Phenobarbital reagent lots 62299UN12 and 85773UN12 due to imprecision issues which increase with the age of the reagent lot. The imprecision of the Phenobarbital assay is d 7% Total CV%; however, internal testing confirmed CVs up to approximately 12% for in-date reagent lots over five months old. Although lot 52803UN12 is now expired, it exhibited similar imprecision issues. As a precaution, future replacement lots will have reduced dating until root cause is identified and preventive measures are implemented.",11/16/2012,"11/16/2012",4/24/2013,"04/24/2013"
"Devices",63946,"Ongoing","Abbott Laboratories, Inc","Irving","TX","US","Voluntary: Firm Initiated","Letter","Nationwide Distribution including AZ, CA, FL, GA, HI, LA, MA, MD, MO, NJ, NY, PA, RI, TN, TX, UT, and WA.","Z-0987-2013","Class II","ARCHITECT HBsAg Qualitative Assay, List Number 4P53 and ARCHITECT HBsAg Qualitative Confirmatory Assay, List Number 4P54 The ARCHITECT HBsAg Qualitative assay is a chemiluminescent microparticle immunoassay (CMIA) for the qualitative detection of hepatitis B surface antigen (HBsAg) in human adult and pediatric serum and plasma and neonate serum. ","All shipped out to this date",,"12","Abbott has identified that assay files for the ARCHITECT HBsAg Qualitative and HBsAg Qualitative Confirmatory assays (LNs 4P53 and 4P54) on the ARCHITECT i1000SR System were mistakenly made available on abbottdiagnostics.com in October 2012. Additionally, some i1000SR customers received notification through AbbottLink in November 2012 that assay files for LNs 4P53 and 4P54 were available. The ARCHITECT HBsAg Qualitative and HBsAg Qualitative Confirmatory assays (LNs 4P53 and 4P54) are not yet approved by the FDA for use on the ARCHITECT i1000SR, but they are under active review for approval. Abbott will notify you when FDA approval is obtained. This is a voluntary device recall.",12/18/2012,"12/18/2012",4/3/2013,"04/03/2013"
"Devices",63947,"Ongoing","St. Jude Medical","Plano","TX","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution - USA Nationwide including Puerto Rico and countries of: Austria, Australia, Belgium, Brazil, Canada, Chile, China, Colombia, Cyprus, Czech Republic, Denmark, Finland, France, Germany, Greece, Hong Kong, India, Ireland, Israel, Italy, Japan, Luxembourg, Martinique, Mexico, Netherlands, Poland, Russian Federal, Saudi Arabia, Singapore, South Africa, South Korea, Spain, Sweden, Switzerland, Turkey and United Kingdom. ","Z-1785-2013","Class II","Eon and Eon Mini charging system, model numbers Eon -3701 (Wall Charger), 3711 (Portable Charger) and Eon Mini -3721 (Charger); This is a continuation of the firm's July 2012 recall. Product Usage: The Eon Wall Charger (3701) provides the capability to recharge the IPG Battery. The charger transmits RF energy through the antenna to the IPG battery to recharge it. The Eon Portable Charger (3711) provides the capability to recharge the IPG battery. The charger transmits RF energy through the antenna to the IPG battery to recharge it. The patient can be mobile during the recharging process with a portable charger. The Eon Mini Charger (3721) provides the capability to recharge the IPG battery while stimulation is either on or off. The charger transmits RF energy through the antenna to the IPG battery to recharge it. ","All serial numbers manufactured",,"75,663","There is issues of warmth or heating at the implant site during charging for the Eon Mini implantable pulse generators (IPGs). In the July 2012 letter St. Jude Medical informed customers that they would be implementing design improvements to the charger to address possible increased energy dissipation when the charger is misaligned with the IPG or the IPG is implanted too near the surface of the skin. This field action is to announce the availability of the newly designed Eon Mini Charger Model 3722 to mitigate excessive heating while charging.",11/30/2012,"11/30/2012",7/31/2013,"07/31/2013"
"Food",63948,"Ongoing","Cap Sur Mer, Inc.","L'etang Du Nord",,"CA","Voluntary: Firm Initiated","E-Mail","Portsmouth, NH; Raynham, MA; Taunton, MA","F-0912-2013","Class I","Frozen Cooked Lobster Meat. TCK Nautifish 6 X 2 lbs. Plastic Bags, 6 individual per case. Keep Frozen","Date of Manufacture: 11/05/12, 11/06/12; Date Code: 12 310 - 12 311. Lot #50022 R, Product # 339 703",".","13 cases - 6 X 2 lb plastic bags per case","The product or a previous product from this date code was found with Listeria monocytogenes through laboratory analysis.",12/18/2012,"12/18/2012",1/23/2013,"01/23/2013"
"Food",63948,"Ongoing","Cap Sur Mer, Inc.","L'etang Du Nord",,"CA","Voluntary: Firm Initiated","E-Mail","Portsmouth, NH; Raynham, MA; Taunton, MA","F-0908-2013","Class I","Apollo Frozen Cooked Lobster Meat. BCKL Lobster Meat 6X2 lb, plastic bags, 6 individual items per case, keep frozen","Date of Manufacture: 10/05/12; Lot # 11244",".","101 cases - 6 X 2lb per case","The product or a previous product from this date code was found with Listeria monocytogenes through laboratory analysis.",12/18/2012,"12/18/2012",1/23/2013,"01/23/2013"
"Food",63948,"Ongoing","Cap Sur Mer, Inc.","L'etang Du Nord",,"CA","Voluntary: Firm Initiated","E-Mail","Portsmouth, NH; Raynham, MA; Taunton, MA","F-0909-2013","Class I","Captain Homard Frozen Cooked Lobster Meat. Broken Tail Meat, 6X2 lb, plastic bags, 6 individual items per case. Keep Frozen.","Date of Manufacture: 10/05/12, 11/05/12, 11/06/12, 11/07/12. Date Code: 12 279: #48293 R; #16046; 12 310, 12 311, 12 312 Lot# 50028 R",".","12 Cases - 6 X 2lb plastic bags/case","The product or a previous product from this date code was found with Listeria monocytogenes through laboratory analysis.",12/18/2012,"12/18/2012",1/23/2013,"01/23/2013"
"Food",63948,"Ongoing","Cap Sur Mer, Inc.","L'etang Du Nord",,"CA","Voluntary: Firm Initiated","E-Mail","Portsmouth, NH; Raynham, MA; Taunton, MA","F-0911-2013","Class I","Frozen Cooked Lobster Meat. Salad Meat 6 X 2 lb. plastic bags, 6 individual items per case. Captain Homard and Apollo. Keep Frozen","Date of Manufacture: 11/04/12, 11/05/12, 11/06/12, 11/07/12; Date Code: 12 309 - 12 312; Lot #50019 and 50432R for Captain Homard; Lot #50020 for Appolo Product #15721",".","780 cases - 6 X 2lb plastic bags/case","This product was found with Listeria monocytogenes through laboratory analysis.",12/18/2012,"12/18/2012",1/23/2013,"01/23/2013"
"Food",63948,"Ongoing","Cap Sur Mer, Inc.","L'etang Du Nord",,"CA","Voluntary: Firm Initiated","E-Mail","Portsmouth, NH; Raynham, MA; Taunton, MA","F-0907-2013","Class I","Nautifish Frozen Cooked Lobster Meat. CKL 12 X 11.3 oz. Metal Cans. 12 items/case. Keep Frozen.","Dates of Manufacture: 10/5/12, 11/4/12, 11/5/12, 11/6/12, 11/7/12. Date Codes: 12 309 to 12 312, Lot #50979 R, Product #12834. Date Code: 12 279. Lot #48213 R, Product number: 12834",".","244 cases of 12 X 11.3oz cans","This product was found with Listeria monocytogenes through laboratory analysis.",12/18/2012,"12/18/2012",1/23/2013,"01/23/2013"
"Food",63948,"Ongoing","Cap Sur Mer, Inc.","L'etang Du Nord",,"CA","Voluntary: Firm Initiated","E-Mail","Portsmouth, NH; Raynham, MA; Taunton, MA","F-0910-2013","Class I","Frozen Cooked Lobster Tail Meat. Nautifish. 2 lb plastic bags, 6 items/case. Keep Frozen","Date of Manufacture: 10/05/12. Date Code 12 279; Product Number: 339538",".","3 cases- 6 X 2 lb plastic bags/case","The product or a previous product from this date code was found with Listeria monocytogenes through laboratory analysis.",12/18/2012,"12/18/2012",1/23/2013,"01/23/2013"
"Devices",63949,"Ongoing","Becton Dickinson & Co.","Sparks","MD","US","Voluntary: Firm Initiated","Letter","USA including CT, FL, IL, KS, MD, MI, MO, NY, PA, RI, TX and WI. Internationally to Canada, Europe and Japan.","Z-0701-2013","Class II","BD MAX (tm) (6 channel) Instruments, Catalog number 441916, labeled in part ***Becton, Dickinson and Company 7 Loveton Circle Sparks, Maryland 21152 USA*** The BD MAX'' System, used in conjunction with appropriate extraction kits and reagents, is capable of automated extraction and purification of nucleic acids from multiple specimen types. The BD MAX System is also capable of automated amplification and detection of target nucleic acid sequences for use in clinical, industrial and research settings. The MAX reader assembly is the optics component of the instrument that translates PCR amplification into curves. The curves are evaluated by an algorithm when used with BD assays to interpret results. For open system reagent (OSR) users, the curve is evaluated manually to interpret the results based on their own validated criteria. The heater is part of an assembly that controls both the thermal cycling during the PCR reaction and the opening of the wax valves in the cartridge consumable. ","Serial Numbers: MX0001 to MX0065 CM0001 to CM0105 NOTE: Serial numbers are assigned sequentially. The above ranges will include all sequential numbers in between the beginning and end points. ",".","86 Instruments","Clinical diagnostic instrument may exhibit minor defects, which could lead to erroneous test results.",9/18/2012,"09/18/2012",1/30/2013,"01/30/2013"
"Food",63950,"Ongoing","Marine Harvest USA, LLC","Doral","FL","US","Voluntary: Firm Initiated","Telephone","AZ, CA, DE, FL, GA, IL, MA, MO, NC, NH, NJ, NY, OH, PA, TX, VA and Puerto Rico","F-0932-2013","Class I","Cold Smoke Salmon in vacuum plastic bags, labeled in part: ***H E B***ALL NATURAL***SMOKED***SALMON***Sliced and Ready to Serve***4 oz***","4oz UPC # 041220630417 Lots = 249 thru 291 Process = 1936",".","951 lbs","Potential to be contaminated with Listeria Monocytogenes",12/21/2012,"12/21/2012",1/30/2013,"01/30/2013"
"Food",63950,"Ongoing","Marine Harvest USA, LLC","Doral","FL","US","Voluntary: Firm Initiated","Telephone","AZ, CA, DE, FL, GA, IL, MA, MO, NC, NH, NJ, NY, OH, PA, TX, VA and Puerto Rico","F-0926-2013","Class I","Cold Smoke Salmon in vacuum plastic bags. Food Service Cold Smoked Salmon Trim 1 lb.","UPC # n/a Lots = 235 thru 345 Process = 7831",".","462 lbs (2,112 lbs on hold)","Potential to be contaminated with Listeria Monocytogenes",12/21/2012,"12/21/2012",1/30/2013,"01/30/2013"
"Food",63950,"Ongoing","Marine Harvest USA, LLC","Doral","FL","US","Voluntary: Firm Initiated","Telephone","AZ, CA, DE, FL, GA, IL, MA, MO, NC, NH, NJ, NY, OH, PA, TX, VA and Puerto Rico","F-0929-2013","Class I","Cold Smoke Salmon in vacuum plastic bags, labeled in part: ***Silver***Source***Smoked***Salmon***Salmon Salar***","Reorders numbers= 230237 (2 Sliced Skin Off Fillets) 230251 (4-5 Sliced Skin Off Fillets) and 230254 (10 Sliced Skin Off Fillets) Process = 7843 Lots = 249 thru 291",".","800 lbs (663 lbs on hold)","Potential to be contaminated with Listeria Monocytogenes",12/21/2012,"12/21/2012",1/30/2013,"01/30/2013"
"Food",63950,"Ongoing","Marine Harvest USA, LLC","Doral","FL","US","Voluntary: Firm Initiated","Telephone","AZ, CA, DE, FL, GA, IL, MA, MO, NC, NH, NJ, NY, OH, PA, TX, VA and Puerto Rico","F-0934-2013","Class I","Cold Smoke Salmon in vacuum plastic bags, labeled in part: ***Smoke***Nova***Salmon***Supreme Fine Foods*** 2lb***","2 lb UPC # 852457001044 Lots = 235 thru 345 Process = 7951",".",,"Potential to be contaminated with Listeria Monocytogenes",12/21/2012,"12/21/2012",1/30/2013,"01/30/2013"
"Food",63950,"Ongoing","Marine Harvest USA, LLC","Doral","FL","US","Voluntary: Firm Initiated","Telephone","AZ, CA, DE, FL, GA, IL, MA, MO, NC, NH, NJ, NY, OH, PA, TX, VA and Puerto Rico","F-0925-2013","Class I","Cold Smoke Salmon in vacuum plastic bags, labeled in part: ***BLACK BEAR***of the BLACK FOREST*** Naturally Smoked***Smoked Salmon***Extra Fancy***1 lb.***","UPC # 810230000493 Lots = 249 thru 291 Process 2305",".","4,800 lbs (1,020 lbs are now on hold)","Potential to be contaminated with Listeria Monocytogenes",12/21/2012,"12/21/2012",1/30/2013,"01/30/2013"
"Food",63950,"Ongoing","Marine Harvest USA, LLC","Doral","FL","US","Voluntary: Firm Initiated","Telephone","AZ, CA, DE, FL, GA, IL, MA, MO, NC, NH, NJ, NY, OH, PA, TX, VA and Puerto Rico","F-0931-2013","Class I","Cold Smoke Salmon in vacuum plastic bags, labeled in part: ***SMOKED***SALMON***Deli Sliced***Ready to Serve***Royal Fjord***Center***Cut Loin***","12 oz - Item 42925 Lots = 235 thru 345 14oz - Item 42925 Lots = 235 thru 345 Process = 7961, 7972, and 7950",".","4,572 lbs","Potential to be contaminated with Listeria Monocytogenes",12/21/2012,"12/21/2012",1/30/2013,"01/30/2013"
"Food",63950,"Ongoing","Marine Harvest USA, LLC","Doral","FL","US","Voluntary: Firm Initiated","Telephone","AZ, CA, DE, FL, GA, IL, MA, MO, NC, NH, NJ, NY, OH, PA, TX, VA and Puerto Rico","F-0930-2013","Class I","Cold Smoke Salmon in vacuum plastic bags, labeled in part: ***Royal Fjord*** Smoked Salmon***Toppers***","6oz UPC #: 810230000561 Lots = 235 thru 345 Process = 7968",".","1,080 lbs (1,436 lbs on hold)","Potential to be contaminated with Listeria Monocytogenes",12/21/2012,"12/21/2012",1/30/2013,"01/30/2013"
"Food",63950,"Ongoing","Marine Harvest USA, LLC","Doral","FL","US","Voluntary: Firm Initiated","Telephone","AZ, CA, DE, FL, GA, IL, MA, MO, NC, NH, NJ, NY, OH, PA, TX, VA and Puerto Rico","F-0928-2013","Class I","Cold Smoke Salmon in vacuum plastic bags. Food Service Whole Smoked Side. Labeled in part: ***Unsliced Cold Smoked*** Salmon Fillet Skin On***","UPC # n/a Lots = 249 thru 291 Process = 7826 & 7823",".","1,011 lbs (3,256 lbs on hold)","Potential to be contaminated with Listeria Monocytogenes",12/21/2012,"12/21/2012",1/30/2013,"01/30/2013"
"Food",63950,"Ongoing","Marine Harvest USA, LLC","Doral","FL","US","Voluntary: Firm Initiated","Telephone","AZ, CA, DE, FL, GA, IL, MA, MO, NC, NH, NJ, NY, OH, PA, TX, VA and Puerto Rico","F-0927-2013","Class I","Cold Smoke Salmon in vacuum plastic bags, labeled in part: ***HAND-PACKED***DARN GOOD***Atlantic Smoked Salmon***KOSHER***einsteinbros.com***","UPC # 099892315200 Lots = 249 thru 291 Process = 7806",".","474 lbs (3,696 lbs on hold now)","Potential to be contaminated with Listeria Monocytogenes",12/21/2012,"12/21/2012",1/30/2013,"01/30/2013"
"Food",63950,"Ongoing","Marine Harvest USA, LLC","Doral","FL","US","Voluntary: Firm Initiated","Telephone","AZ, CA, DE, FL, GA, IL, MA, MO, NC, NH, NJ, NY, OH, PA, TX, VA and Puerto Rico","F-0933-2013","Class I","Cold Smoke Salmon in vacuum plastic bags, labeled in part: ***Royal Fjord***Smoked Salmon***Rounds***5oz***","4oz UPC # 810230000127 Lots = 235 thru 345 Process = 7951",".",,"Potential to be contaminated with Listeria Monocytogenes",12/21/2012,"12/21/2012",1/30/2013,"01/30/2013"
"Food",63950,"Ongoing","Marine Harvest USA, LLC","Doral","FL","US","Voluntary: Firm Initiated","Telephone","AZ, CA, DE, FL, GA, IL, MA, MO, NC, NH, NJ, NY, OH, PA, TX, VA and Puerto Rico","F-0935-2013","Class I","Cold Smoke Salmon in vacuum plastic bags, labeled in part: ***New England Smoked Salmon***","4oz UPC # 810230000066 Lots = 235 thru 345 Process = 7951",".",,"Potential to be contaminated with Listeria Monocytogenes",12/21/2012,"12/21/2012",1/30/2013,"01/30/2013"
"Devices",63951,"Ongoing","Cardinal Health","Mc Gaw Park","IL","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution - USA (Nationwide) and the countries of Australia, Canada and Japan.","Z-0980-2013","Class II","Needle Counters with Blade Disarmer; 11.5 x 6.5 x 3.3 cm; 15 Count/30 Capacity; Sterile; Removable Numbered Foam Block; Magnetic Area (Cat. No. 4FS30SSA) Needle Counters with Blade Disarmer; 11.5 x 6.5 x 3.3 cm; 15 Count/30 Capacity; Sterile; Removable Numbered Foam Block; Double Foam Strips (Cat. No. 4FS31SSA) Needle Counters with Blade Disarmer; 11.5 x 6.5 x 3.3 cm; 15 Count/30 Capacity; Sterile; Double Numbered Magnets (Cat. No. 4MM30SSA) Product Usage: Disposal system for counting of used surgical blades and needles. ","Catalog Number: 4FS30SSALot Numbers: all lot numbers less than or equal to 848031 Catalog Number: 4FS31SSA Lot Numbers: lot number 739269 Catalog Number: 4MM30SSA Lot Numbers: all lot numbers less than or equal to 858154",,"Cat. No. 4FS30SSA: 7488; Cat. No. 4FS31SSA: 48; Cat. No. 4MM30SSA: 6336 ","Small holes (approximately 1 mm or less) found in device unit level packaging potentially compromising product sterility.",12/18/2012,"12/18/2012",4/3/2013,"04/03/2013"
"Devices",63951,"Ongoing","Cardinal Health","Mc Gaw Park","IL","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution - USA (Nationwide) and the countries of Australia, Canada and Japan.","Z-0981-2013","Class II","Needle Counters; Sterile; Foam Strip; 12.2 x 10.5 x 1.7 cm; 30 Count/60 Capacity; Sterile; Foam Strip; Magnetic Area (Cat. No. 3FS60SSA) Needle Counters; Sterile; Foam Strip; 12.2 x 10.5 x 1.7 cm; 30 Count/60 Capacity; Sterile; Double Foam Strips; (Cat. No. 3FS61SSA) Needle Counters; Sterile; Foam Strip; 12.2 x 10.5 x 1.7 cm; 30 Count/60 Capacity; Sterile; Double Numbered Magnets (Cat. No. 3MM60SSA) Product Usage: Disposal system for counting of used surgical blades and needles. ","Catalog Number: 3FS60SSALot Numbers: all lot numbers less than or equal to 898712 Catalog Number: 3FS61SSA Lot Numbers: all lot numbers less than or equal to 898714 Catalog Number: 3MM60SSA Lot Numbers: all lot numbers less than or equal to 931754",,"Cat. No. 3FS60SSA: 7,560; Cat. No. 3FS61SSA: 14,184; Cat. No. 3MM60SSA: 12,384","Small holes (approximately 1 mm or less) found in device unit level packaging potentially compromising product sterility.",12/18/2012,"12/18/2012",4/3/2013,"04/03/2013"
"Devices",63951,"Ongoing","Cardinal Health","Mc Gaw Park","IL","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution - USA (Nationwide) and the countries of Australia, Canada and Japan.","Z-0985-2013","Class II","Needle Counters with Blade Disarmer; 12.2 x 10.5 x 3.5 cm; 40 Count/70 Capacity; Sterile; Removable Numbered Foam Block; Adhesive Area (Cat. No. 4FA70SSA) Needle Counters with Blade Disarmer; 12.2 x 10.5 x 3.5 cm; 40 Count/70 Capacity; Sterile; Removable Numbered Foam Block; Magnetic Area (Cat. No. 4FM70SSA) Product Usage: Disposal system for counting of used surgical blades and needles. ","Catalog Number: 4FA70SSALot Numbers: all lot numbers less than or equal to 931750 Catalog Number: 4FM70SSA Lot Numbers: all lot numbers less than or equal to 912173",,"Cat. No. 4FA70SSA: 1,248; Cat. No. 4FM70SSA: 43,920","Small holes (approximately 1 mm or less) found in device unit level packaging potentially compromising product sterility.",12/18/2012,"12/18/2012",4/3/2013,"04/03/2013"
"Devices",63951,"Ongoing","Cardinal Health","Mc Gaw Park","IL","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution - USA (Nationwide) and the countries of Australia, Canada and Japan.","Z-0983-2013","Class II","Needle Counters; 12.2 x 10.5 x 3.5 cm; 40 Count/70 Capacity; Sterile; Removable Numbered Foam Block; Adhesive Area (Cat. No. 3FA70SSA) Needle Counters; 12.2 x 10.5 x 3.5 cm; 40 Count/70 Capacity; Sterile; Removable Numbered Foam Block; Magnetic Area; (Cat. No. 3FM70SSA) Product Usage: Disposal system for counting of used surgical blades and needles. ","Catalog Number: 3FA70SSALot Numbers: all lot numbers less than or equal to 843761 Catalog Number: 3FM70SSA Lot Numbers: all lot numbers less than or equal to 933614 ",,"Cat. No. 3FA70SSA: 23,808; Cat. No. 3FM70SSA: 54,912","Small holes (approximately 1 mm or less) found in device unit level packaging potentially compromising product sterility.",12/18/2012,"12/18/2012",4/3/2013,"04/03/2013"
"Devices",63951,"Ongoing","Cardinal Health","Mc Gaw Park","IL","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution - USA (Nationwide) and the countries of Australia, Canada and Japan.","Z-0978-2013","Class II","Needle Counters; 11.5 x 6.5 x 3.3 cm; 20 Count/40 Capacity; Sterile; Removable Numbered Foam Block; Adhesive Area (Cat. No. 3FA40SSA) Needle Counters; 11.5 x 6.5 x 3.3 cm; 20 Count/40 Capacity; Sterile; Removable Numbered Foam Block; Magnetic Area (Cat. No. 3FM40SSA) Product Usage: Disposal system for counting of used surgical blades and needles. ","Catalog Number: 3FA40SSALot Numbers: all lot numbers less than or equal to 928782 Catalog Number: 3FM40SSA Lot Numbers: all lot numbers less than or equal to 911379",,"Cat. No. 3FA40SSA: 23,952; Cat. No. 3FM40SSA: 140,736","Small holes (approximately 1 mm or less) found in device unit level packaging potentially compromising product sterility.",12/18/2012,"12/18/2012",4/3/2013,"04/03/2013"
"Devices",63951,"Ongoing","Cardinal Health","Mc Gaw Park","IL","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution - USA (Nationwide) and the countries of Australia, Canada and Japan.","Z-0979-2013","Class II","Needle Counters with Blade Disarmer; 11.5 x 6.5 x 3.3 cm; 20 Count/40 Capacity; Sterile; Removable Numbered Foam Block; Adhesive Area (Cat. No. 4FA40SSA) Needle Counters with Blade Disarmer; 11.5 x 6.5 x 3.3 cm; 20 Count/40 Capacity; Sterile; Removable Numbered Foam Block; Magnetic Area (Cat. No. 4FM40SSA) Product Usage: Disposal system for counting of used surgical blades and needles. ","Catalog Number: FA40SSALot Numbers: lot number 763998 Catalog Number: 4FM40SSA Lot Numbers: all lot numbers less than or equal to 933099",,"Cat. No. 4FA40SSA: 96; Cat. No. 4FM40SSA: 32,592","Small holes (approximately 1 mm or less) found in device unit level packaging potentially compromising product sterility.",12/18/2012,"12/18/2012",4/3/2013,"04/03/2013"
"Devices",63951,"Ongoing","Cardinal Health","Mc Gaw Park","IL","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution - USA (Nationwide) and the countries of Australia, Canada and Japan.","Z-0982-2013","Class II","Needle Counters with Blade Disarmer; 12.2 x 10.5 x 1.7 cm; 30 Count/60 Capacity; Sterile; Foam Strip; Magnetic Area (Cat. No. 4FS60SSA) Needle Counters with Blade Disarmer; 12.2 x 10.5 x 1.7 cm; 30 Count/60 Capacity; Sterile; Double Foam Strips (Cat. No. 4FS61SSA) Needle Counters with Blade Disarmer; 12.2 x 10.5 x 1.7 cm; 30 Count/60 Capacity; Sterile; Double Numbered Magnets (Cat. No. 4MM60SSA) Product Usage: Disposal system for counting of used surgical blades and needles. ","Catalog Number: 4FS60SSALot Numbers: all lot numbers less than or equal to 752068 Catalog Number: 4FS61SSA Lot Numbers: all lot numbers less than or equal to 802581 Catalog Number: 4MM60SSA Lot Numbers: all lot numbers less than or equal to 898715",,"Cat. No. 4FS60SSA: 576; Cat. No. 4FS61SSA: 14,760; Cat. No. 4MM60SSA: 5,184","Small holes (approximately 1 mm or less) found in device unit level packaging potentially compromising product sterility.",12/18/2012,"12/18/2012",4/3/2013,"04/03/2013"
"Devices",63951,"Ongoing","Cardinal Health","Mc Gaw Park","IL","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution - USA (Nationwide) and the countries of Australia, Canada and Japan.","Z-0986-2013","Class II","Needle Counters with Blade Disarmer; 12.2 x 10.5 x 3.5 cm; 60 Count/100 Capacity; Sterile; Removable Numbered Foam Block; Double Numbered Magnets (Cat. No. 4FM100SSA) Product Usage: Disposal system for counting of used surgical blades and needles. ","Catalog Number: 4FM100SSALot Numbers: all lot numbers less than or equal to 847028",,"Cat. No. 4FM100SSA: 4,464","Small holes (approximately 1 mm or less) found in device unit level packaging potentially compromising product sterility.",12/18/2012,"12/18/2012",4/3/2013,"04/03/2013"
"Devices",63951,"Ongoing","Cardinal Health","Mc Gaw Park","IL","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution - USA (Nationwide) and the countries of Australia, Canada and Japan.","Z-0984-2013","Class II","Needle Counters; 12.2 x 10.5 x 3.5 cm; 40 Count/80 Capacity; Sterile; Double Removable Numbered Foam Blocks (Cat. No. 3FF80SSA) Product Usage: Disposal system for counting of used surgical blades and needles. ","Catalog Number: 3FF80SSALot Numbers: all lot numbers less than or equal to 912899 ",,"Cat. No. 3FF80SSA: 16224","Small holes (approximately 1 mm or less) found in device unit level packaging potentially compromising product sterility.",12/18/2012,"12/18/2012",4/3/2013,"04/03/2013"
"Drugs",63952,"Ongoing","Boehringer Ingelheim Roxane Inc","Columbus","OH","US","Voluntary: Firm Initiated","Letter","Nationwide","D-126-2013","Class III","Perindopril Erbumine Tablets, 8mg, 100 Tablets per Bottle, Rx Only, Boehringer Ingelheim, Roxane Laboratories Inc., Columbus, OH 43216, NDC 0054-0112-25.","Lot #160017A, Exp 04/2013.",".","3,553 bottles","Impurities/Degradation Products: Out of Specification results found for impurity B, identified as the drug's metabolite.",12/12/2012,"12/12/2012",1/23/2013,"01/23/2013"
"Drugs",63953,"Completed","Green Valley Drugs","Henderson","NV","US","Voluntary: Firm Initiated","Letter","Nationwide","D-322-2013","Class I","Cyanocobalamin 1000 mcg/ml, injection 30 mL, MDV, For Office Use Only, Green Valley Drugs, Manufactured by Green Valley Drugs, Henderson, NV.","Lot: 20121126-H",,"58 x 30 ml Vials","Non-Sterility: Green Valley Drugs received positive sterility results from their testing lab on two lots of Methylprednisolone Preservative Free 40 mg/mL injectable suspension and one lot of Cyanocobalamin 1000 mcg/mL injection, 30 mL MDV.",12/4/2012,"12/04/2012",5/22/2013,"05/22/2013"
"Drugs",63953,"Completed","Green Valley Drugs","Henderson","NV","US","Voluntary: Firm Initiated","Letter","Nationwide","D-321-2013","Class I","Methylprednisolone Preservative Free 40 mg/ml Injectible Suspension, 1 mL Vials and 2 mL Vials and 1 mL pre-filled syringes, For Office Use Only, Manufactured by Green Valley Drugs, Henderson, NV.","Lot #s: 20121105-B, 20121112-G",,"1395 Vials total; 900x1 ml vials 20121105-B; 90x 2ml vials of lot 20121112-G and 495x1 ml vials of lot 20121112-G. ","Non-Sterility: Green Valley Drugs received positive sterility results from their testing lab on two lots of Methylprednisolone Preservative Free 40 mg/mL injectable suspension and one lot of Cyanocobalamin 1000 mcg/mL injection, 30 mL MDV.",12/4/2012,"12/04/2012",5/22/2013,"05/22/2013"
"Food",63954,"Ongoing","Pepsi Cola North America","Valhalla","NY","US","Voluntary: Firm Initiated","Letter","Massachusetts, Connecticut, Maine, New Hampshire and Vermont","F-0924-2013","Class III","Regular Wild Cherry Pepsi two liter plastic bottles UPC 1231100 ","Best Before Date of Feb2513 and a Manufacturing Code of PF11282",".","1064 - 8 pack cases","The labels on two-liter batches of Regular and Diet Wild Cherry Pepsi were mistakenly swapped during production. This is potential safety issue for individuals who are sensitive to phenylalanine (i.e., phenylketonuric) or who are diabetic.",12/20/2012,"12/20/2012",1/30/2013,"01/30/2013"
"Food",63954,"Ongoing","Pepsi Cola North America","Valhalla","NY","US","Voluntary: Firm Initiated","Letter","Massachusetts, Connecticut, Maine, New Hampshire and Vermont","F-0923-2013","Class II","Diet Wild Cherry Pepsi two liter plastic bottles UPC 1234107 ","Best Before Date of Feb2513 and a Manufacturing Code of PF11282",".","1476 - 8 pack cases","The labels on two-liter batches of Regular and Diet Wild Cherry Pepsi were mistakenly swapped during production. This is potential safety issue for individuals who are sensitive to phenylalanine (i.e., phenylketonuric) or who are diabetic.",12/20/2012,"12/20/2012",1/30/2013,"01/30/2013"
"Food",63955,"Ongoing","Cardinal Health","Zanesville","OH","US","Voluntary: Firm Initiated","Letter","Product was shipped to the following states: NJ & NY","F-0916-2013","Class II","Dairy Aid Lactase Enzyme Supplement, Caplet, 3,000 FCC Units, 60 caplets, OTC, Repackaged by: Cardinal Health, Zanesville, OH 43701, NDC 55154-1335-4","White, oblong caplet, imprinted RP143; Batch# M675030, Lot # 10627AA, Exp Date 11/2012; Batch# M679370, Lot # 10627BA, Exp Date 12/2012; Batch# M675020, Lot # 10627A, Exp Date 11/2012; Batch# M679360, Lot # 10627B, Exp Date 12/2012; Batch# M707960, Lot # 10627C, Exp Date 3/2013; Batch# M712800, Lot # 11469A, Exp Date 3/2013; Batch# M740490, Lot # 11464B, Exp Date 6/2013; Batch# M743510, Lot # 13973A, Exp Date 7/2013.",".","1,140 caplets","The firm discovered that the labeling bears an incorrect strength of 9,000 FCC Units per caplet instead of 3,000 FCC units per caplet.",11/13/2012,"11/13/2012",1/30/2013,"01/30/2013"
"Food",63956,"Ongoing","Haig's Delicacies","Hayward","CA","US","Voluntary: Firm Initiated","Press Release","CA, WA and MD","F-0921-2013","Class I","Spanakopita; a triangular phyllo dough pastry with spinach and cheese filling. sold in 5 lb. bulk Foodservice cases. Undeclared wheat, milk and eggs Manufactured by Haig's Delicacies, Hayward, CA.","all products",".","3087 cases","State of CA inspection found four products that do not declare allergy statements which reflect the use of milk, wheat and eggs.",12/21/2012,"12/21/2012",1/30/2013,"01/30/2013"
"Food",63956,"Ongoing","Haig's Delicacies","Hayward","CA","US","Voluntary: Firm Initiated","Press Release","CA, WA and MD","F-0920-2013","Class II","Falafel with Tahini Sauce; nuggets of ground garbanzo beans with a rich, tangy tahini sauce. Sold in 5 oz retail rectangular deli containers and 5 lb bulk foodservice. Undeclared wheat Manufactured by Haigs Delicacies, Hayward, CA.","all products",".","471 retail, 3723 5 lb balls.","State of CA inspection found four products do not declare allergy statements which reflect the use of milk, wheat and eggs.",12/21/2012,"12/21/2012",1/30/2013,"01/30/2013"
"Food",63956,"Ongoing","Haig's Delicacies","Hayward","CA","US","Voluntary: Firm Initiated","Press Release","CA, WA and MD","F-0922-2013","Class I","Tyropita; a triangular phyllo dough pastry with cheese filling. sold in 5 lb. bulk Foodservice cases . Undeclared wheat, milk and eggs. Manufactured by Haig s Delicacies, Hayward, CA.","all products",".","74 cases","State of CA inspection found four products that do not declare allergy statements which reflect the use of milk, wheat and eggs.",12/21/2012,"12/21/2012",1/30/2013,"01/30/2013"
"Food",63956,"Ongoing","Haig's Delicacies","Hayward","CA","US","Voluntary: Firm Initiated","Press Release","CA, WA and MD","F-0919-2013","Class I","Tzatziki; Greek yogurt with cucumber and dill. sold in 8 oz retail and 5 lb bulk food service containers. Undeclared milk. Manufactured by Haigs Delicacies, Hayward, CA.","all products",".","3093 8 oz cups, 157 cases 5 lb bulk","State of CA inspection found four products that do not declare allergy statements which reflect the use of milk, wheat and eggs.",12/21/2012,"12/21/2012",1/30/2013,"01/30/2013"
"Devices",63957,"Terminated","Intel-GE Care Innovations LLC","Roseville","CA","US","Voluntary: Firm Initiated","Letter","Nationwide Distribution.","Z-0877-2013","Class II","QuietCare-Networked product, Facility Server/model: QC101601; The QuietCare system is intended to detect and analyze residents' movements. ","All units of this model.",,"19 units","Care Innovations detected a software anomaly: During the engineering investigation into the cause of why a Wander Alert was not generated, a defect in the implementation of the Wander and Night Motion ADLs was discovered. ",12/16/2012,"12/16/2012",3/6/2013,"03/06/2013"
"Devices",63958,"Ongoing","Becton Dickinson & Co.","Sparks","MD","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution-USA including the states of MA, TN, KY, IN, GA, NC, TX, NY, FL, AZ, WA, NJ, MI, and CA, and the countries of Uruguay, Taiwan, Singapore, Australia, South Korea, Mexico, Hong Kong, Guatemala, Columbia, Chile, Canada, India, Japan, Brazil, China and Belgium.","Z-0699-2013","Class II","BBL Crystal Enteric/Nonfermenter ID Kit, Catalog # 24500, cartons of 20 kits, labeled in part ***Becton, Dickinson and Company, Sparks MD 21152*** The BBL Crystal Enteric/Nonfermentor (E/NF) identification (ID) System is for the identification of aerobic gram-negative bacteria that belong to the family Enterobacteriaceae as well as some of the more frequently isolated glucose fermenting and nonfermenting gram-negative bacilli. ","Lot Number/ Exp Date 2086315 February 20, 2013 2101435 February 20, 2013 2104316 February 27, 2013 2129460 February 27, 2013 2129487 March 13, 2013 2163211 February 27, 2013 2163213 March 20, 2013 2163215 March 27, 2013 ",".","67,820 units","In-vitro diagnostic reagents for microbiological testing may be reversed in well positions in the test kit and when utilized may lead to bacteria misidentification.",12/13/2012,"12/13/2012",1/30/2013,"01/30/2013"
"Devices",63959,"Ongoing","Medisystems a NX Stage Company","Lawrence","MA","US","Voluntary: Firm Initiated","E-Mail","US Nationwide Distribution in the states of NY, PA and TN.","Z-0715-2013","Class II","Medisystems 17 Gauge x 1'' inch AV Fistula Needle Product Code: D9-2007MGLB Product Usage: Medisystems AVF with MasterGuard anti-stick needle protector is indicated for use as a vascular access device in hemodialysis or other extracorporeal procedures. It is intended for use in conjunction with a blood tubing set equipped with a standard medical male luer-locking connector"," Lot: Number: 110914F8",".","16 cases (15 cs x 250 ea) 4,000 needles","Single needle packs in each case ( 10 needles per case) are mislabeled on the pouch as 15 Gauge needles instead of 17 Gauge",12/20/2012,"12/20/2012",1/30/2013,"01/30/2013"
"Devices",63959,"Ongoing","Medisystems a NX Stage Company","Lawrence","MA","US","Voluntary: Firm Initiated","E-Mail","US Nationwide Distribution in the states of NY, PA and TN.","Z-0714-2013","Class II"," Medisystems 15 Gauge x 3/5 inch Buttonhole Needle Set Product Code: BH-2035PE Product Usage: Medisystems Buttonhole Needle Sets are indicated for use as an access device for dialysis and pheresis procedures using a constant site orbuttonhole method of needle insertion. "," Lot: 120719F4",".","26 casesx 250 needles (6500needles)","A total of 5 (ea) single needle pouches are mislabeled as 15 Ga x1'' instead of 15 Ga x 3/5''.",12/20/2012,"12/20/2012",1/30/2013,"01/30/2013"
"Biologics",63961,"Terminated","Michigan Blood","Grand Rapids","MI","US","Voluntary: Firm Initiated","FAX","Michigan","B-0882-13","Class II","Platelets Pooled Leukocytes Reduced","W120612183019; ",".","1","Blood product, collected from a donor whose suitability to donate was not adequately determined, was distributed.",11/9/2012,"11/09/2012",4/10/2013,"04/10/2013"
"Biologics",63962,"Terminated","Indiana Blood Center","Indianapolis","IN","US","Voluntary: Firm Initiated","Telephone","Indiana","B-0881-13","Class II","Red Blood Cells (Apheresis) Leukocytes Reduced","W040712468837; W040712468837; ",".","2","Blood products, collected from a donor who reported a post donation illness, were distributed.",11/14/2012,"11/14/2012",4/10/2013,"04/10/2013"
"Biologics",63963,"Terminated","DCI Biologicals, LLC","Little Rock","AR","US","Voluntary: Firm Initiated","FAX","United Kingdom","B-0945-13","Class II","Source Plasma","LR0398479; LR0398836; LR0400355; LR400556; LR0402075; LR0403071; LR0403464 ",".","7","Blood products, collected from a donor who received a tattoo within 12 months of donating, were distributed.",11/9/2012,"11/09/2012",4/10/2013,"04/10/2013"
"Biologics",63964,"Terminated","American National Red Cross Southeastern Michigan Region","Detroit","MI","US","Voluntary: Firm Initiated","FAX","Michigan","B-0877-13","Class III","Platelets Pooled Leukocytes Reduced","013FY04668; ",".","1","Blood Products, collected from a donor who received varicella zoster vaccine less than 28 days before donating, were distributed.",10/11/2012,"10/11/2012",4/10/2013,"04/10/2013"
"Biologics",63964,"Terminated","American National Red Cross Southeastern Michigan Region","Detroit","MI","US","Voluntary: Firm Initiated","FAX","Michigan","B-0878-13","Class III","Red Blood Cells Leukocytes Reduced","013FY04668; ",".","1","Blood Products, collected from a donor who received varicella zoster vaccine less than 28 days before donating, were distributed.",10/11/2012,"10/11/2012",4/10/2013,"04/10/2013"
"Food",63965,"Ongoing","New B.C.N. Trading Inc","South Plainfield","NJ","US","Voluntary: Firm Initiated","Telephone","CT, FL, NJ, NY, PA, & VA","F-0870-2013","Class III","Asian Boy (EBQ) Tapioca Stick 3.5 oz (100g) New B.C.N. Trading Inc. 701 Hadky South Plainfield, NJ 07080 MINH NGUYET TRADING CO., LTD. BIN CHANH -HOCHIMINH CITY VIETNAM UPC 627404021822","UPC 627404021822",".","71 cases (50 retail units per carton)","Tapoica stick contains undeclared sulfites.",10/23/2012,"10/23/2012",1/16/2013,"01/16/2013"
"Drugs",63966,"Ongoing","L. Perrigo Co.","Allegan","MI","US","Voluntary: Firm Initiated","Letter","Nationwide","D-125-2013","Class II","Prednisone tablets, USP, 10mg, Rx Only, Units of Use, NDC: a) 45802-303-67, 48-count Cartons, b) 45802-303-21, 21-count Cartons, Manufactured by: West-Ward Pharmaceutical Corporation, Eastown, NJ 07724, Distributed by: Perrigo, Allegan, MI 49040.","Lot #s: a) 2DV1238, Exp10/13; 2CV0623, 2CV0625, Exp 11/13; b) 2DV1239, Exp 10/13; 2CV0627, Exp 11/13",".","86,616 Tablets","Presence of Foreign Substance(s); Perrigo has been notified of a recall by the manufacturer of this product, West-Ward Pharmaceuticals. This is a sub-recall due to tablets contaminated with trace amounts of food-grade lubricant, as well as stainless steel inclusions",12/17/2012,"12/17/2012",1/23/2013,"01/23/2013"
"Drugs",63967,"Ongoing","West-ward Pharmaceutical Corp.","Eatontown","NJ","US","Voluntary: Firm Initiated","Letter","Nationwide and Puerto Rico","D-132-2013","Class II","Lisinopril and Hydrochlorothiazide Tablets, 20 mg/25 mg, packaged in a) 100-count tablets per bottle (NDC 0143-1264-01) and b) 1000-count tablets per bottle (NDC 0143-1264-10), Rx only, Manufactured by: West-ward Pharmaceutical Corp., Eatontown, NJ 07724.","Lot #: 69392A, 69393A, 69394A, 69395A, 69396A, 69397A , Exp 09/15; 69495A, 69496A, 69497A, 69498A, 69524A, 69525A, Exp 10/15",".","43,478 bottles","Presence of Foreign Substance: Reports of gray smudges identified as minute stainless steel particulates were found in the recalled tablets.",11/30/2012,"11/30/2012",1/30/2013,"01/30/2013"
"Veterinary",63968,"Ongoing","ADM Alliance Nutrition, Inc.","Bluffton","IN","US","Voluntary: Firm Initiated","Telephone","IN, IL, OH, KY, PA, and MI","V-165-2013","Class I","MoorMan's ShowTec 18 Elite Lamb DC medicated textured grain mix, packaged in 50 lb bags","Lot BF23512 - manufactured 08/22/12 184 - 50lb bags produced for sale Lot BF27812 - manufactured 10/04/12 120 - 50lb bags produced for sale Lot BF29312 - manufactured 10/19/12 73 - 50lb bags produced for sale ",,"377 - 50 lb bags","ADM Alliance Nutrition of Bluffton, IN initiated a recall on 12/19/12 for 3 lots of MoorMans ShowTec 18 Elite Lamb DC sold in 50 lb bags. The recall was initiated in response to a customer complaint stating that 2 of the customers sheep had died of copper toxicosis after consuming MoorMan's ShowTec 18 Elite Lamb DC. ",12/19/2012,"12/19/2012",5/22/2013,"05/22/2013"
"Drugs",63969,"Ongoing","West-ward Pharmaceutical Corp.","Eatontown","NJ","US","Voluntary: Firm Initiated","Letter","Nationwide and Puerto Rico","D-149-2013","Class II","PredniSONE Tablets, USP, 10 mg, packaged in a) 100-count tablets per bottle (NDC 0143-1473-01), b) 1000-count tablets per bottle (NDC 0143-1473-10), Rx only, Manufactured by: West-ward Pharmaceutical Corp., Eatowntown, NJ 07724.","Lot #: 69403A, 69403B, Exp 10/15; 69404A, 69405A, 69515A, 69702A, 69702B, 69703A, Exp 11/15; 69767A, 69767B, Exp 12/15",,"128,319 bottles","Presence of Foreign Substance: Tablets are being recalled due to gray defects identified in the tablets.",12/5/2012,"12/05/2012",2/13/2013,"02/13/2013"
"Food",63970,"Ongoing","Suadel Food Products, Inc.","Bayamon","PR","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Puerto Rico only","F-0971-2013","Class II","''ESTRELLA***Empanadillas de Pizza'' (Pizza turnovers)***5 units, 12 units and 24 units***Elaborado y Empacado por: Estrella Food Products, Inc., Bayamon, PR 00959-1906***''.","No code",,"6, 288 units","Undeclared wheat and undeclared milk as the source of cheese.",12/21/2012,"12/21/2012",2/20/2013,"02/20/2013"
"Food",63970,"Ongoing","Suadel Food Products, Inc.","Bayamon","PR","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Puerto Rico only","F-0974-2013","Class I","''Estrella Food Products, Inc***Empanadillas Sabor a Carne(Meat flavorTurnovers)***5 units, 12 units and 24 units***Elaborado y Empacado por: Estrella Food Products, Inc., Bayamon, PR 00959-1906***''.","No code",,"2,412 units","Wheat and soy is not declared.",12/21/2012,"12/21/2012",2/20/2013,"02/20/2013"
"Food",63970,"Ongoing","Suadel Food Products, Inc.","Bayamon","PR","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Puerto Rico only","F-0975-2013","Class II","''Estrella Food Products, Inc***Plantillas Para Pastelillos, tacos, Empanadillas, etc. (Yellow dough shells)***12 units, and 20 units***Manufactured by: Estrella Food Products, Inc., Minillas Industrial Park,Bayamon, PR 00959-1906***''.","No code",,"99,984 units","Undeclared Yellow #6 and soy",12/21/2012,"12/21/2012",2/20/2013,"02/20/2013"
"Food",63970,"Ongoing","Suadel Food Products, Inc.","Bayamon","PR","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Puerto Rico only","F-0972-2013","Class II","''Estrella Food Products, Inc***Pastelillos de Queso (Cheese Mini Turnovers)***6 units***Manufactured by: Estrella Food Products, Inc., Minilla Industrial Park, Bayamon, PR 00959-1906***''.","No code",,"11,592 units","Casein is listed as a sub-ingredient of cheese, but common name ''milk'' is not declared in the list of ingredients and/or ''Contains'' statement.",12/21/2012,"12/21/2012",2/20/2013,"02/20/2013"
"Food",63970,"Ongoing","Suadel Food Products, Inc.","Bayamon","PR","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Puerto Rico only","F-0973-2013","Class II","''Estrella Food Products, Inc***Pastelillos de Pizza (Pizza Mini Turnovers)***6 units***Manufactured by: Estrella Food Products, Inc., Minilla Industrial Park, Bayamon, PR 00959-1906***''.","No code",,"10,440 units","Casein is listed as a sub-ingredient of cheese, but common name ''milk'' is not declared in the list of ingredients and/or ''Contains'' statement.",12/21/2012,"12/21/2012",2/20/2013,"02/20/2013"
"Food",63970,"Ongoing","Suadel Food Products, Inc.","Bayamon","PR","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Puerto Rico only","F-0976-2013","Class III","''Estrella Food Products, Inc***Pastelillos de Guayaba (Guava Mini Turnovers)***6 units***Manufactured by: Estrella Food Products, Inc., Minillas Industrial Park,Bayamon, PR 00959-1906***''.","No code",,"3,672 units","Undeclared Red #40",12/21/2012,"12/21/2012",2/20/2013,"02/20/2013"
"Drugs",63971,"Ongoing","West-ward Pharmaceutical Corp.","Eatontown","NJ","US","Voluntary: Firm Initiated","Letter","Nationwide and Puerto Rico","D-133-2013","Class II","PredniSONE Tablets, USP, 20 mg, packaged in a) 100-count tablets per bottle (NDC 0143-1477-01), b) 500-count tablets per bottle (NDC 0143-1477-05), and c) 1000-count tablets per bottle (NDC 0143-1477-10), Rx only, Manufactured by: West-ward Pharmaceutical Corp., Eatowntown, NJ 07724.","Lot #: 68581A, 68581B, 68382A, 68382B, 68578A, 68578B, 68579A, 68580A, 68582A, 68582B, Exp 01/15",".","60,289 bottles","Presence of Foreign Substance: A complaint was received for black specks identified as stainless steel inclusions and cellulose with trace amounts of aluminum and iron-rich inclusions.",12/5/2012,"12/05/2012",1/30/2013,"01/30/2013"
"Devices",63972,"Ongoing","AMS Innovative Center - San Jose","San Jose","CA","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution.","Z-0700-2013","Class II","GreenLight HPS (High Performance System) GreenLight XPS ( Xcelerated Performance System) Manufactured by AMS, Solutions for Life Innovation Center - Silicon Valley, 3070 Orchard Drive, San Jose, CA 95134. GreenLight HPS and XPS Surgical Lasers Systems and accessories are intended for use in endoscopic 532 nm laser resection of the prostate for the treatment of benign prostatic hyperplasis. The entire laser unit and controls are contained in a single console that is connected to external electricity and are required to meet IEC 60601.","HPS Part numbers: 0010-0070 to 0010-0077; XPS Part numbers: 0010-0210 Serial numbers: HPS2095R1 HPS3079C2 HPS3080C1 HPS3089C1 HPS3091C1 HPS3096C1 HPS3099C1 HPS3100C1 HPS3101C1 HPS3102C1 HPS3103 HPS3104C1 HPS3105C1 HPS3107 HPS3108C1 HPS3109C1 HPS3110C2 HPS3112 HPS3113 HPS3114 HPS3115 HPS3116 HPS3117 HPS3118 HPS3119 HPS3120 HPS3121 HPS3122 HPS3123 HPS3124 HPS3125 HPS3126 HPS3127 HPS3128 HPS3129 HPS3130 HPS3131 HPS3132 HPS3134 HPS3136 HPS3137 HPS3139 HPS3142 HPS3143 HPS3144 HPS3145 XPS50084 XPS50241 XPS50301 XPS50302 XPS50312 XPS50313 XPS50314 XPS50315 XPS50316 XPS50317 XPS50318 XPS50319 XPS50320 XPS50321 XPS50322 XPS50323 XPS50324 XPS50325 XPS50326 XPS50327 XPS50328 XPS50329 XPS50330 XPS50331 XPS50332 XPS50333 XPS50334 XPS50335 XPS50336 XPS50337 XPS50338 XPS50339 XPS50340 XPS50341 XPS50342 XPS50343 XPS50344 XPS50345 XPS50346 XPS50347 XPS50348 XPS50349 XPS50350 XPS50351 XPS50352 XPS50353 XPS50354 XPS50355 XPS50356C1 XPS50357 XPS50358 XPS50359 XPS50360 XPS50361 XPS50362 XPS50363 XPS50364 XPS50367 XPS50368 XPS50369 XPS50371 XPS50372C1 XPS50373 XPS50374 XPS50375 XPS50376 XPS50377 XPS50378 XPS50379 XPS50380 XPS50381 XPS50382 XPS50383 XPS50384 XPS50385 XPS50386 XPS50388 XPS50389 XPS50390 XPS50391 XPS50392 XPS50393 XPS50394 XPS50395 XPS50396 XPS50397 XPS50398 XPS50399 XPS50400 XPS50401 XPS50402 XPS50403 XPS50404 XPS50405 XPS50406 XPS50407 XPS50408 XPS50409 XPS50410 XPS50412 XPS50413 XPS50414 XPS50415 XPS50416 XPS50417 XPS50418 XPS50419 XPS50420 XPS50421 XPS50422 XPS50423 XPS50424 XPS50426C1 XPS50427 XPS50428 XPS50430 XPS50431 XPS50432 XPS50433 XPS50434 XPS50435C1 XPS50436 XPS50437C1 XPS50438 XPS50439 XPS50440 XPS50441 XPS50442 XPS50443 XPS50444 XPS50446 XPS50447 XPS50448 XPS50449 XPS50450 XPS50451 XPS50452 XPS50453 XPS50454 XPS50455 XPS50456 XPS50457 XPS50458 XPS50459 XPS50460 XPS50461 XPS50462 XPS50463 XPS50464 XPS50465 XPS",".","389 devices, all model numbers.","During electrical recertification testing it was found that the Voltage Scaling Board was non-conforming to the IEC 60601-1-2 standard.",12/11/2012,"12/11/2012",1/30/2013,"01/30/2013"
"Devices",63973,"Ongoing","DePuy Orthopaedics, Inc.","Warsaw","IN","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution - USA Nationwide.","Z-0971-2013","Class II","Specialist 2 IM Rod, Non-Sterile and associated Surgical Techniques:Sigma HP Instruments Classic Surgical Technique,0612-89-510 Sigma HP Instruments Balanced Surgical Technique, 0612-88-510 Sigma HP Instruments Fixed Reference Surgical Technique, 0612-87-510 PFC Sigma Knee Systems Primary Cruciate-Retaining & Cruciate-Substituting Procedure Surgical Technique,SP2-007 Product Usage: The SP2 IM Rod is used in both primary and revision Sigma knee procedures to align the femoral locating device and distal femoral cutting block. It is also used with the IM tibial resection. This rod is included in both the SP2 and HP instrument kits. ","Product Code 96-6120Label code / Etch code C3JHN4 H0808 C3JHS4 H0908 C3JHF4 H1008 C4GA54 C4GCC4 C4GBT4 C52F74 H1108 C52GV4 H1208 C52GL4 C67N14 C98CS4 H0109 C98BF4 DE5P34 H0309 DE5RP4 DF4H44 DG9LK4 H0409 DG9L64 DJ5E34 DK3E34 H0509 DK3FE4 EB5FV4 H0210 D95AN4 EB5GH4 H0310 EC9JY4 EF4DJ4 EJ7AP4 H0410 ES2G64 H0510 EJ7A34 ES2HA4 H0610 ES2HY4 H0710 EX5L44 EX5MS4 H0810 E2SD44 H0910 FA4G94 H0211 FD8MP4 H0311 FH8JA4 FH8JX4 H0611 TBACC TBACC TBACZ TBACZ FJ4E74 TBAGG ",".","4000; 2600 in USA","Potential for the IM rod to break, leaving fragments in the patient. Surgical Techniques guidance has been updated until design changes can be made to reduce likelihood of potential failure. ",2/5/2013,"02/05/2013",3/27/2013,"03/27/2013"
"Devices",63974,"Ongoing","Siemens Medical Solutions USA, Inc","Martinez","CA","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution","Z-1077-2013","Class II","ELEKTA MOSAIQ SW version below 2.41 Product Usage: The intended use of the SIEMENS branded ARTISTE and ONCOR family of linear accelerator systems is to deliver X-ray photon and electron radiation for the therapeutic treatment of cancer. ","System No. 10568605:100044100078 100085 100088 100098 100135 100020 100025 100001 100002 100003 100004 100006 100007 100008 100009 100010 100011 100012 100013 100014 100016 100017 100019 100023 100024 100028 100029 100030 100031 100032 100033 100034 100035 100036 100037 100038 100039 100040 100041 100042 100045 100047 100049 100051 100052 100053 100054 100056 100058 100059 100060 100061 100062 100063 100065 100066 100068 100069 100070 100071 100072 100073 100074 100075 100077 100079 100080 100082 100086 100087 100089 100090 100091 100092 100093 100094 100099 100101 100103 100104 100106 100107 100108 100111 100112 100113 100114 100115 100118 100119 100120 100121 100123 100124 100125 100126 100127 100130 100131 100133 100136 100138 100140. ",,"101","A potential safety risk with the MOSAIQ OncologyInformation System that has been identified by the manufacturer IMPAC Medical Systems, Inc.",12/20/2012,"12/20/2012",4/17/2013,"04/17/2013"
"Food",63977,"Ongoing","The Father's Table, LLC","Sanford","FL","US","Voluntary: Firm Initiated","E-Mail","DOMESTIC: Arkansas, California, New Jersey, New York, North Carolina, Ohio, Oregon, Pennsylvania, Texas, Washington, and Wisconsin INTERNATIONAL: Trinidad and Tobago","F-0939-2013","Class III","Individual packages labeled in part: ***The Bakery baked with pride***Vanilla Mini Cake Roll***8oz**** with strawberry filling*** NETWT 8oz (226g) ","UPC' #s = L02367N SKU # 02367",".","5,535 cases / 12 rolls / 8oz ea","Incorrectly labeled with a label that does not list strawberries and color additives (FC&C Red 40 and Blue 1).",12/14/2012,"12/14/2012",2/6/2013,"02/06/2013"
"Food",63977,"Ongoing","The Father's Table, LLC","Sanford","FL","US","Voluntary: Firm Initiated","E-Mail","DOMESTIC: Arkansas, California, New Jersey, New York, North Carolina, Ohio, Oregon, Pennsylvania, Texas, Washington, and Wisconsin INTERNATIONAL: Trinidad and Tobago","F-0938-2013","Class III","Individual packages labeled in part: ***The Father's Table***Vanilla Roll***8oz**** and Master carton labeled in part: ''The Father's Table***Shelf Stable*** Mini Vanilla Roll***Contains 12/8oz.*** ","UPC' #s = L72483N, L49983N, and L49983N SKU # 49983, 72483, and 63583",".","3,733 cartons / 12 rolls / 8 oz ea","Incorrectly labeled with a label that does not list strawberries and color additives (FC&C Red 40 and Blue 1).",12/14/2012,"12/14/2012",2/6/2013,"02/06/2013"
"Food",63978,"Ongoing","J F C International Inc","Los Angeles","CA","US","Voluntary: Firm Initiated","Letter","nationwide in the US","F-0950-2013","Class III","WP Saki Ika Cuttlefish JFC# 15603, 4/24/0.75oz; JFC# 06315, 8/12/2oz; JFC# 07266, 5/12/4oz; JFC# 06375, 3/12/8oz.","JFC# Lot# 15603 Q066A & Q109A; 06315 Q065A & Q108A; 07266 Q067A & Q110A; 06375 Q066A & Q109A.",".","500 cartons","JFC International is recalling WelPac Saki Ika Cuttlefish because of mold.",10/31/2012,"10/31/2012",2/6/2013,"02/06/2013"
"Food",63978,"Ongoing","J F C International Inc","Los Angeles","CA","US","Voluntary: Firm Initiated","Letter","nationwide in the US","F-0951-2013","Class III","WP Saki Ika Cuttlefish Hot JFC# 15606, 4/24/0.75 oz; JFC# 06318, 8/12/2 oz; JFC# 07269, 5/12/4 oz; JFC# 06360, 3/12/8 oz. ","JFC# Lot# 15606 Q069A & Q110A; 06318 Q068A & Q111A; 07269 Q070A & Q112A; 06360 Q069A & Q112A.",".","500 cartons","JFC International is recalling WelPac Saki Ika Cuttlefish because of mold.",10/31/2012,"10/31/2012",2/6/2013,"02/06/2013"
"Food",63980,"Ongoing","Multiexport Foods, Inc.","Miami","FL","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Alabama, Arkansas, Alaska, Arizona, California, Colorado, Connecticut, Delaware, Florida, Georgia, Hawaii, Iowa, Idaho, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Maine, Montana, Missouri, Mississippi, Nebraska, North Carolina, New Hampshire, New Jersey, New York, New Mexico, Nevada, Ohio, Oklahoma, Pennsylvania, Puerto Rico, South Carolina, Tennessee, Texas, Utah, Washington, Virginia, Wisconsin and West Virginia","F-0875-2013","Class I","Product labeled in part: ***PARAMOUNT RESERVE***PRODUCT OF CHILE FARM RAISED ATLANTIC SALMON PACKED BY: ALIMENTOS MULTIEXPORT S.A. *** DISTRIBUTED BY MULTIEXPORT FOODS INC. 703 WATERFORD WAY (NW 62ND AVE) SUITE 510, MIAMI, FL 33126***","Twin Pack 12 oz = 931-59733-2, 933-59753-1, 933-59754-2, 875-701413-1, and 890-701413-1 // 12oz UPC 6 88264 86705 0 ===================================== 1.25 lb Pack = 870-701342-1, 873-701342-1, 870-701344-1, 873-701360-1, 870-701364-1, 873-701364-1, 900-701344-1, 873-701344-1, 873-701360-1, 886-701413-1, 900-701413-1, 873-701344-1, and 870-701360-1 // 1.25 lb UPC 6 88264 86664 0",".",,"The firm initiated the recall based on positive results for Listeria monocytogenes obtained from a composite sample tested by a private laboratory.",12/18/2012,"12/18/2012",1/16/2013,"01/16/2013"
"Devices",63981,"Ongoing","ConMed Corporation","Utica","NY","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Worldwide Distribution - USA (nationwide) Puerto Rico and internationally to Belgium, Colombia, Czech Republic, Dubai, Guatamala, Hong Kong, India, Israel, Italy, Japan, Kenya, Kuwait, Malaysia, Mexico, New Zealand, Norway, Oman, Pakistan, Portugal, Saudi Arabia, Thailand, and Uruguay.","Z-0729-2013","Class II","UltraClean(R) Accessory Electrode, 1 inch Coated Blade, REF/Catalog No. 139100, Single Use, Sterile, Rx ONLY --CONMED CORPORATION, UTICA, NY 13502 --- Product Name: Electrosurgery Active Electrodes and Accessories; Common First Name: Electrosurgical, Cutting and Coagulation and Accessories. MDL D085930. The ESP Electrode blades are components for electrosurgical pencils. The electrodes provide specific shapes and lengths to allow the clinician to utilize these different configurations for various clinical applications. The UltraClean version differs from the Universal as it has a ''non-stick'' finish. The Single Use ABC Nozzle is intended for use in the operating room for any procedure in which an electrosurgical generator would be used, i.e. for the surgical removal of tissue and for the control of bleeding. ","Beginning Lot Code 120628X, Ending Lot Code 120917X. [Lot codes on boxes and packaging contain a lot code in the following format: 12 09 17 X where 12 represents the year (2012), 09 represents the month (September), 17 represents the day of the month, and X represents the manufacturing shift code (1, 2, 3, 4,5,6 or 9)].",".",,"ConMed received complaints of some devices which had broken through the seal of the sterile pouch. ConMed confirmed instances where the pouch seal was compromised on the affected products. In no instance has it been reported to ConMed that a compromise in the sterile barrier has resulted in illness or injury. The compromised seals were discovered prior to use.",12/27/2012,"12/27/2012",1/30/2013,"01/30/2013"
"Devices",63981,"Ongoing","ConMed Corporation","Utica","NY","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Worldwide Distribution - USA (nationwide) Puerto Rico and internationally to Belgium, Colombia, Czech Republic, Dubai, Guatamala, Hong Kong, India, Israel, Italy, Japan, Kenya, Kuwait, Malaysia, Mexico, New Zealand, Norway, Oman, Pakistan, Portugal, Saudi Arabia, Thailand, and Uruguay.","Z-0726-2013","Class II","CONMED(R) ELECTROSURGICAL SAFETY HOLSTER, Disposable Safety Holster, REF/Catalog No. 137668, Sterile, Rx ONLY -- CONMED CORPORATION 525 FRENCH RD., UTICA, NY 13502-5994 --- Product Name: Electrosurgery Active Electrodes and Accessories; Common First Name: Electrosurgical, Cutting and Coagulation and Accessories. MDL D092249. The ESP Electrode blades are components for electrosurgical pencils. The electrodes provide specific shapes and lengths to allow the clinician to utilize these different configurations for various clinical applications. The UltraClean version differs from the Universal as it has a ''non-stick'' finish. The Single Use ABC Nozzle is intended for use in the operating room for any procedure in which an electrosurgical generator would be used, i.e. for the surgical removal of tissue and for the control of bleeding. ","Beginning Lot Code 120628X, Ending Lot Code 120917X. [Lot codes on boxes and packaging contain a lot code in the following format: 120917X where 12 represents the year (2012), 09 represents the month (September), 17 represents the day of the month, and X represents the manufacturing shift code (1, 2, 3, 4,5,6 or 9)].",".",,"ConMed received complaints of some devices which had broken through the seal of the sterile pouch. ConMed confirmed instances where the pouch seal was compromised on the affected products. In no instance has it been reported to ConMed that a compromise in the sterile barrier has resulted in illness or injury. The compromised seals were discovered prior to use.",12/27/2012,"12/27/2012",1/30/2013,"01/30/2013"
"Devices",63981,"Ongoing","ConMed Corporation","Utica","NY","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Worldwide Distribution - USA (nationwide) Puerto Rico and internationally to Belgium, Colombia, Czech Republic, Dubai, Guatamala, Hong Kong, India, Israel, Italy, Japan, Kenya, Kuwait, Malaysia, Mexico, New Zealand, Norway, Oman, Pakistan, Portugal, Saudi Arabia, Thailand, and Uruguay.","Z-0722-2013","Class II","Goldvac(TM) UltraClean(R) Accessory Electrode 4 inch Coated Blade, REF/Catalog No. 60-7524-001, Sterile, Rx ONLY -- CONMED CORPORATION 525 FRENCH ROAD, UTICA, NY 13502-5994 --- Product Name: Electrosurgery Active Electrodes and Accessories; Common First Name: Electrosurgical, Cutting and Coagulation and Accessories. MDL D085930. The ESP Electrode blades are components for electrosurgical pencils. The electrodes provide specific shapes and lengths to allow the clinician to utilize these different configurations for various clinical applications. The UltraClean version differs from the Universal as it has a ''non-stick'' finish. The Single Use ABC Nozzle is intended for use in the operating room for any procedure in which an electrosurgical generator would be used, i.e. for the surgical removal of tissue and for the control of bleeding. ","Beginning Lot Code 120628X, Ending Lot Code 120917X. [Lot codes on boxes and packaging contain a lot code in the following format: 120917X where 12 represents the year (2012), 09 represents the month (September), 17 represents the day of the month, and X represents the manufacturing shift code (1, 2, 3, 4,5,6 or 9)].",".",,"ConMed received complaints of some devices which had broken through the seal of the sterile pouch. ConMed confirmed instances where the pouch seal was compromised on the affected products. In no instance has it been reported to ConMed that a compromise in the sterile barrier has resulted in illness or injury. The compromised seals were discovered prior to use.",12/27/2012,"12/27/2012",1/30/2013,"01/30/2013"
"Devices",63981,"Ongoing","ConMed Corporation","Utica","NY","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Worldwide Distribution - USA (nationwide) Puerto Rico and internationally to Belgium, Colombia, Czech Republic, Dubai, Guatamala, Hong Kong, India, Israel, Italy, Japan, Kenya, Kuwait, Malaysia, Mexico, New Zealand, Norway, Oman, Pakistan, Portugal, Saudi Arabia, Thailand, and Uruguay.","Z-0724-2013","Class II","ABC(R) NOZZLE, Single Patient Use Nozzle, (For use with 130500 Reusable ABC(R) Handpiece), REF/Catalog No. 130343, Sterile, Rx ONLY -- CONMED CORPORATION 525 FRENCH RD., UTICA, NY 13502-5994 --- Product Name: Electrosurgery Active Electrodes and Accessories; Common First Name: Electrosurgical, Cutting and Coagulation and Accessories. MDL E323246. The ESP Electrode blades are components for electrosurgical pencils. The electrodes provide specific shapes and lengths to allow the clinician to utilize these different configurations for various clinical applications. The UltraClean version differs from the Universal as it has a ''non-stick'' finish. The Single Use ABC Nozzle is intended for use in the operating room for any procedure in which an electrosurgical generator would be used, i.e. for the surgical removal of tissue and for the control of bleeding. ","Beginning Lot Code 120628X, Ending Lot Code 120917X. [Lot codes on boxes and packaging contain a lot code in the following format: 120917X where 12 represents the year (2012), 09 represents the month (September), 17 represents the day of the month, and X represents the manufacturing shift code (1, 2, 3, 4,5,6 or 9)].",".",,"ConMed received complaints of some devices which had broken through the seal of the sterile pouch. ConMed confirmed instances where the pouch seal was compromised on the affected products. In no instance has it been reported to ConMed that a compromise in the sterile barrier has resulted in illness or injury. The compromised seals were discovered prior to use.",12/27/2012,"12/27/2012",1/30/2013,"01/30/2013"
"Devices",63981,"Ongoing","ConMed Corporation","Utica","NY","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Worldwide Distribution - USA (nationwide) Puerto Rico and internationally to Belgium, Colombia, Czech Republic, Dubai, Guatamala, Hong Kong, India, Israel, Italy, Japan, Kenya, Kuwait, Malaysia, Mexico, New Zealand, Norway, Oman, Pakistan, Portugal, Saudi Arabia, Thailand, and Uruguay.","Z-0720-2013","Class II","Goldvac(TM) UltraClean(R) Accessory Electrode 1 inch Coated Blade with Extended Insulation, REF/Catalog No. 60-7521-001, Sterile, Rx ONLY -- CONMED CORPORATION 525 FRENCH ROAD, UTICA, NY 13502-5994 --- Product Name: Electrosurgery Active Electrodes and Accessories; Common First Name: Electrosurgical, Cutting and Coagulation and Accessories. MDL D085930. The ESP Electrode blades are components for electrosurgical pencils. The electrodes provide specific shapes and lengths to allow the clinician to utilize these different configurations for various clinical applications. The UltraClean version differs from the Universal as it has a ''non-stick'' finish. The Single Use ABC Nozzle is intended for use in the operating room for any procedure in which an electrosurgical generator would be used, i.e. for the surgical removal of tissue and for the control of bleeding. ","Beginning Lot Code 120628X, Ending Lot Code 120917X. [Lot codes on boxes and packaging contain a lot code in the following format: 120917X where 12 represents the year (2012), 09 represents the month (September), 17 represents the day of the month, and X represents the manufacturing shift code (1, 2, 3, 4,5,6 or 9)].",".",,"ConMed received complaints of some devices which had broken through the seal of the sterile pouch. ConMed confirmed instances where the pouch seal was compromised on the affected products. In no instance has it been reported to ConMed that a compromise in the sterile barrier has resulted in illness or injury. The compromised seals were discovered prior to use.",12/27/2012,"12/27/2012",1/30/2013,"01/30/2013"
"Devices",63981,"Ongoing","ConMed Corporation","Utica","NY","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Worldwide Distribution - USA (nationwide) Puerto Rico and internationally to Belgium, Colombia, Czech Republic, Dubai, Guatamala, Hong Kong, India, Israel, Italy, Japan, Kenya, Kuwait, Malaysia, Mexico, New Zealand, Norway, Oman, Pakistan, Portugal, Saudi Arabia, Thailand, and Uruguay.","Z-0736-2013","Class II","UltraClean(R) Accessory Electrode 4 inch Coated Blade, REF/Catalog No. 139112, Single Use, Sterile, Rx ONLY -- CONMED CORPORATION 525 FRENCH ROAD, UTICA, NY 13502-5994 --- Product Name: Electrosurgery Active Electrodes and Accessories; Common First Name: Electrosurgical, Cutting and Coagulation and Accessories. MDL D085930. The ESP Electrode blades are components for electrosurgical pencils. The electrodes provide specific shapes and lengths to allow the clinician to utilize these different configurations for various clinical applications. The UltraClean version differs from the Universal as it has a ''non-stick'' finish. The Single Use ABC Nozzle is intended for use in the operating room for any procedure in which an electrosurgical generator would be used, i.e. for the surgical removal of tissue and for the control of bleeding. ","Beginning Lot Code 120628X, Ending Lot Code 120917X. [Lot codes on boxes and packaging contain a lot code in the following format: 120917X where 12 represents the year (2012), 09 represents the month (September), 17 represents the day of the month, and X represents the manufacturing shift code (1, 2, 3, 4,5,6 or 9)].",".",,"ConMed received complaints of some devices which had broken through the seal of the sterile pouch. ConMed confirmed instances where the pouch seal was compromised on the affected products. In no instance has it been reported to ConMed that a compromise in the sterile barrier has resulted in illness or injury. The compromised seals were discovered prior to use.",12/27/2012,"12/27/2012",1/30/2013,"01/30/2013"
"Devices",63981,"Ongoing","ConMed Corporation","Utica","NY","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Worldwide Distribution - USA (nationwide) Puerto Rico and internationally to Belgium, Colombia, Czech Republic, Dubai, Guatamala, Hong Kong, India, Israel, Italy, Japan, Kenya, Kuwait, Malaysia, Mexico, New Zealand, Norway, Oman, Pakistan, Portugal, Saudi Arabia, Thailand, and Uruguay.","Z-0727-2013","Class II","ELECTROSURGICAL ENT NEEDLE ELECTRODE, 6 inch with Extended Insulation, REF/Catalog No. 138025, Single Use, Sterile, Rx ONLY -- CONMED CORPORATION 525 FRENCH RD., UTICA, NY 13502-5994 --- Product Name: Electrosurgery Active Electrodes and Accessories; Common First Name: Electrosurgical, Cutting and Coagulation and Accessories. MDL D092258. The ESP Electrode blades are components for electrosurgical pencils. The electrodes provide specific shapes and lengths to allow the clinician to utilize these different configurations for various clinical applications. The UltraClean version differs from the Universal as it has a ''non-stick'' finish. The Single Use ABC Nozzle is intended for use in the operating room for any procedure in which an electrosurgical generator would be used, i.e. for the surgical removal of tissue and for the control of bleeding. ","Beginning Lot Code 120628X, Ending Lot Code 120917X. [Lot codes on boxes and packaging contain a lot code in the following format: 120917 X where 12 represents the year (2012), 09 represents the month (September), 17 represents the day of the month, and X represents the manufacturing shift code (1, 2, 3, 4,5,6 or 9)].",".",,"ConMed received complaints of some devices which had broken through the seal of the sterile pouch. ConMed confirmed instances where the pouch seal was compromised on the affected products. In no instance has it been reported to ConMed that a compromise in the sterile barrier has resulted in illness or injury. The compromised seals were discovered prior to use.",12/27/2012,"12/27/2012",1/30/2013,"01/30/2013"
"Devices",63981,"Ongoing","ConMed Corporation","Utica","NY","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Worldwide Distribution - USA (nationwide) Puerto Rico and internationally to Belgium, Colombia, Czech Republic, Dubai, Guatamala, Hong Kong, India, Israel, Italy, Japan, Kenya, Kuwait, Malaysia, Mexico, New Zealand, Norway, Oman, Pakistan, Portugal, Saudi Arabia, Thailand, and Uruguay.","Z-0718-2013","Class II","ELECTROLASE(R) HYFRECATOR(R) ELECTRODES - SHARP, Disposable Hyfrecator(R) Tips, REF/Catalog No. 7-100-8CS, Sterile, Rx ONLY -- CONMED CORPORATION 525 FRENCH RD., UTICA, NY 13502-5994 --- Product Name: Electrosurgery Active Electrodes and Accessories; Common First Name: Electrosurgical, Cutting and Coagulation and Accessories. MDL D092250. The Electrolase Sterile Disposable Electrodes are intended to be used as active RF electrodes for desiccation, fulguration and coagulation. The ESP Electrode blades are components for electrosurgical pencils. The electrodes provide specific shapes and lengths to allow the clinician to utilize these different configurations for various clinical applications. The UltraClean version differs from the Universal as it has a ''non-stick'' finish. The Single Use ABC Nozzle is intended for use in the operating room for any procedure in which an electrosurgical generator would be used, i.e. for the surgical removal of tissue and for the control of bleeding. ","Beginning Lot Code 120628X, Ending Lot Code 120917X. [Lot codes on boxes and packaging contain a lot code in the following format: 120917X where 12 represents the year (2012), 09 represents the month (September), 17 represents the day of the month, and X represents the manufacturing shift code (1, 2, 3, 4,5,6 or 9)].",".",,"ConMed received complaints of some devices which had broken through the seal of the sterile pouch. ConMed confirmed instances where the pouch seal was compromised on the affected products. In no instance has it been reported to ConMed that a compromise in the sterile barrier has resulted in illness or injury. The compromised seals were discovered prior to use.",12/27/2012,"12/27/2012",1/30/2013,"01/30/2013"
"Devices",63981,"Ongoing","ConMed Corporation","Utica","NY","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Worldwide Distribution - USA (nationwide) Puerto Rico and internationally to Belgium, Colombia, Czech Republic, Dubai, Guatamala, Hong Kong, India, Israel, Italy, Japan, Kenya, Kuwait, Malaysia, Mexico, New Zealand, Norway, Oman, Pakistan, Portugal, Saudi Arabia, Thailand, and Uruguay.","Z-0730-2013","Class II","UltraClean(R) Accessory Electrode 1 inch Coated Needle, REF/Catalog No. 139102, Single Use, Sterile, Rx ONLY -- CONMED CORPORATION 525 FRENCH ROAD, UTICA, NY 13502-5994 --- Product Name: Electrosurgery Active Electrodes and Accessories; Common First Name: Electrosurgical, Cutting and Coagulation and Accessories. MDL D085930. The ESP Electrode blades are components for electrosurgical pencils. The electrodes provide specific shapes and lengths to allow the clinician to utilize these different configurations for various clinical applications. The UltraClean version differs from the Universal as it has a ''non-stick'' finish. The Single Use ABC Nozzle is intended for use in the operating room for any procedure in which an electrosurgical generator would be used, i.e. for the surgical removal of tissue and for the control of bleeding. ","Beginning Lot Code 120628X, Ending Lot Code 120917X. [Lot codes on boxes and packaging contain a lot code in the following format: 120917X where 12 represents the year (2012), 09 represents the month (September), 17 represents the day of the month, and X represents the manufacturing shift code (1, 2, 3, 4,5,6 or 9)].",".",,"ConMed received complaints of some devices which had broken through the seal of the sterile pouch. ConMed confirmed instances where the pouch seal was compromised on the affected products. In no instance has it been reported to ConMed that a compromise in the sterile barrier has resulted in illness or injury. The compromised seals were discovered prior to use.",12/27/2012,"12/27/2012",1/30/2013,"01/30/2013"
"Devices",63981,"Ongoing","ConMed Corporation","Utica","NY","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Worldwide Distribution - USA (nationwide) Puerto Rico and internationally to Belgium, Colombia, Czech Republic, Dubai, Guatamala, Hong Kong, India, Israel, Italy, Japan, Kenya, Kuwait, Malaysia, Mexico, New Zealand, Norway, Oman, Pakistan, Portugal, Saudi Arabia, Thailand, and Uruguay.","Z-0728-2013","Class II","Electrosurgical Tip Cleaner, REF/Catalog No. 138029, Single Use, Sterile, Rx ONLY -- Distributed By: CONMED CORPORATION 525 French Road, Utica, NY 13502-5944 --- Product Name: Electrosurgery Active Electrodes and Accessories; Common First Name: Electrosurgical, Cutting and Coagulation and Accessories. MDL D092281. The ESP Electrode blades are components for electrosurgical pencils. The electrodes provide specific shapes and lengths to allow the clinician to utilize these different configurations for various clinical applications. The UltraClean version differs from the Universal as it has a ''non-stick'' finish. The Single Use ABC Nozzle is intended for use in the operating room for any procedure in which an electrosurgical generator would be used, i.e. for the surgical removal of tissue and for the control of bleeding. ","Beginning Lot Code 120628X, Ending Lot Code 120725X. [Lot codes on boxes and packaging contain a lot code in the following form: 120725X where 12 represents the year (2012), 07 represents the month (July), 25 represents the day of the month, and X represents the manufacturing shift code (1, 2, 3, 4,5,6 or 9)].",".",,"ConMed received complaints of some devices which had broken through the seal of the sterile pouch. ConMed confirmed instances where the pouch seal was compromised on the affected products. In no instance has it been reported to ConMed that a compromise in the sterile barrier has resulted in illness or injury. The compromised seals were discovered prior to use.",12/27/2012,"12/27/2012",1/30/2013,"01/30/2013"
"Devices",63981,"Ongoing","ConMed Corporation","Utica","NY","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Worldwide Distribution - USA (nationwide) Puerto Rico and internationally to Belgium, Colombia, Czech Republic, Dubai, Guatamala, Hong Kong, India, Israel, Italy, Japan, Kenya, Kuwait, Malaysia, Mexico, New Zealand, Norway, Oman, Pakistan, Portugal, Saudi Arabia, Thailand, and Uruguay.","Z-0733-2013","Class II","UltraClean(R) Accessory Electrode 6 inch Coated Blade, REF/Catalog No. 139107, Single Use, Sterile, Rx ONLY -- CONMED CORPORATION, 525 FRENCH RD., UTICA, NY 13502-5994 --- Product Name: Electrosurgery Active Electrodes and Accessories; Common First Name: Electrosurgical, Cutting and Coagulation and Accessories. MDL D085930. The ESP Electrode blades are components for electrosurgical pencils. The electrodes provide specific shapes and lengths to allow the clinician to utilize these different configurations for various clinical applications. The UltraClean version differs from the Universal as it has a ''non-stick'' finish. The Single Use ABC Nozzle is intended for use in the operating room for any procedure in which an electrosurgical generator would be used, i.e. for the surgical removal of tissue and for the control of bleeding. ","Beginning Lot Code 120628X, Ending Lot Code 120917X. [Lot codes on boxes and packaging contain a lot code in the following format: 120917X where 12 represents the year (2012), 09 represents the month (September), 17 represents the day of the month, and X represents the manufacturing shift code (1, 2, 3, 4,5,6 or 9)].",".",,"ConMed received complaints of some devices which had broken through the seal of the sterile pouch. ConMed confirmed instances where the pouch seal was compromised on the affected products. In no instance has it been reported to ConMed that a compromise in the sterile barrier has resulted in illness or injury. The compromised seals were discovered prior to use.",12/27/2012,"12/27/2012",1/30/2013,"01/30/2013"
"Devices",63981,"Ongoing","ConMed Corporation","Utica","NY","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Worldwide Distribution - USA (nationwide) Puerto Rico and internationally to Belgium, Colombia, Czech Republic, Dubai, Guatamala, Hong Kong, India, Israel, Italy, Japan, Kenya, Kuwait, Malaysia, Mexico, New Zealand, Norway, Oman, Pakistan, Portugal, Saudi Arabia, Thailand, and Uruguay.","Z-0725-2013","Class II","TUR/Endoscopic Cable, 10 feet (3.05 mm), REF/Catalog No. 135171, Disposable, Sterile, Rx ONLY -- CONMED CORPORATION 525 FRENCH RD., UTICA, NY 13502-5994 --- Product Name: Electrosurgery Active Electrodes and Accessories; Common First Name: Electrosurgical, Cutting and Coagulation and Accessories. MDL D092258. The ESP Electrode blades are components for electrosurgical pencils. The electrodes provide specific shapes and lengths to allow the clinician to utilize these different configurations for various clinical applications. The UltraClean version differs from the Universal as it has a ''non-stick'' finish. The Single Use ABC Nozzle is intended for use in the operating room for any procedure in which an electrosurgical generator would be used, i.e. for the surgical removal of tissue and for the control of bleeding. ","Beginning Lot Code 120628X, Ending Lot Code 120917X. [Lot codes on boxes and packaging contain a lot code in the following format: 120917X where 12 represents the year (2012), 09 represents the month (September), 17 represents the day of the month, and X represents the manufacturing shift code (1, 2, 3, 4,5,6 or 9)].",".",,"ConMed received complaints of some devices which had broken through the seal of the sterile pouch. ConMed confirmed instances where the pouch seal was compromised on the affected products. In no instance has it been reported to ConMed that a compromise in the sterile barrier has resulted in illness or injury. The compromised seals were discovered prior to use.",12/27/2012,"12/27/2012",1/30/2013,"01/30/2013"
"Devices",63981,"Ongoing","ConMed Corporation","Utica","NY","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Worldwide Distribution - USA (nationwide) Puerto Rico and internationally to Belgium, Colombia, Czech Republic, Dubai, Guatamala, Hong Kong, India, Israel, Italy, Japan, Kenya, Kuwait, Malaysia, Mexico, New Zealand, Norway, Oman, Pakistan, Portugal, Saudi Arabia, Thailand, and Uruguay.","Z-0723-2013","Class II","Goldvac(TM) UltraClean(R) Accessory Electrode 6 inch Coated Blade, REF/Catalog No. 60-7526-001, Sterile, Rx ONLY -- CONMED CORPORATION 525 FRENCH RD., UTICA, NY 13502-5994 --- Product Name: Electrosurgery Active Electrodes and Accessories; Common First Name: Electrosurgical, Cutting and Coagulation and Accessories. MDL D085930. The ESP Electrode blades are components for electrosurgical pencils. The electrodes provide specific shapes and lengths to allow the clinician to utilize these different configurations for various clinical applications. The UltraClean version differs from the Universal as it has a ''non-stick'' finish. The Single Use ABC Nozzle is intended for use in the operating room for any procedure in which an electrosurgical generator would be used, i.e. for the surgical removal of tissue and for the control of bleeding. ","Beginning Lot Code 120628X, Ending Lot Code 120917X. [Lot codes on boxes and packaging contain a lot code in the following format: 120917X where 12 represents the year (2012), 09 represents the month (September), 17 represents the day of the month, and X represents the manufacturing shift code (1, 2, 3, 4,5,6 or 9)].",".",,"ConMed received complaints of some devices which had broken through the seal of the sterile pouch. ConMed confirmed instances where the pouch seal was compromised on the affected products. In no instance has it been reported to ConMed that a compromise in the sterile barrier has resulted in illness or injury. The compromised seals were discovered prior to use.",12/27/2012,"12/27/2012",1/30/2013,"01/30/2013"
"Devices",63981,"Ongoing","ConMed Corporation","Utica","NY","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Worldwide Distribution - USA (nationwide) Puerto Rico and internationally to Belgium, Colombia, Czech Republic, Dubai, Guatamala, Hong Kong, India, Israel, Italy, Japan, Kenya, Kuwait, Malaysia, Mexico, New Zealand, Norway, Oman, Pakistan, Portugal, Saudi Arabia, Thailand, and Uruguay.","Z-0721-2013","Class II","Goldvac(TM) UltraClean(R) Accessory Electrode 6 inch Coated Blade with Extended Insulation, REF/Catalog No. 60-7523-001, Sterile, Rx ONLY -- CONMED CORPORATION, 525 FRENCH ROAD, UTICA, NY 13502-5994 --- Product Name: Electrosurgery Active Electrodes and Accessories; Common First Name: Electrosurgical, Cutting and Coagulation and Accessories. MDL D085930. The ESP Electrode blades are components for electrosurgical pencils. The electrodes provide specific shapes and lengths to allow the clinician to utilize these different configurations for various clinical applications. The UltraClean version differs from the Universal as it has a ''non-stick'' finish. The Single Use ABC Nozzle is intended for use in the operating room for any procedure in which an electrosurgical generator would be used, i.e. for the surgical removal of tissue and for the control of bleeding. ","Beginning Lot Code 120628X, Ending Lot Code 120917X. [Lot codes on boxes and packaging contain a lot code in the following format: 120917X where 12 represents the year (2012), 09 represents the month (September), 17 represents the day of the month, and X represents the manufacturing shift code (1, 2, 3, 4,5,6 or 9)].",".",,"ConMed received complaints of some devices which had broken through the seal of the sterile pouch. ConMed confirmed instances where the pouch seal was compromised on the affected products. In no instance has it been reported to ConMed that a compromise in the sterile barrier has resulted in illness or injury. The compromised seals were discovered prior to use.",12/27/2012,"12/27/2012",1/30/2013,"01/30/2013"
"Devices",63981,"Ongoing","ConMed Corporation","Utica","NY","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Worldwide Distribution - USA (nationwide) Puerto Rico and internationally to Belgium, Colombia, Czech Republic, Dubai, Guatamala, Hong Kong, India, Israel, Italy, Japan, Kenya, Kuwait, Malaysia, Mexico, New Zealand, Norway, Oman, Pakistan, Portugal, Saudi Arabia, Thailand, and Uruguay.","Z-0735-2013","Class II","UltraClean(R) Accessory Electrode 6 inch Coated Blade with Extended Insulation, REF/Catalog No. 139110EXT, Single Use, Sterile, Rx ONLY -- CONMED CORPORATION 525 FRENCH ROAD, UTICA, NY 13502-5944 --- Product Name: Electrosurgery Active Electrodes and Accessories; Common First Name: Electrosurgical, Cutting and Coagulation and Accessories. MDL D085930. The ESP Electrode blades are components for electrosurgical pencils. The electrodes provide specific shapes and lengths to allow the clinician to utilize these different configurations for various clinical applications. The UltraClean version differs from the Universal as it has a ''non-stick'' finish. The Single Use ABC Nozzle is intended for use in the operating room for any procedure in which an electrosurgical generator would be used, i.e. for the surgical removal of tissue and for the control of bleeding. ","Beginning Lot Code 120628X, Ending Lot Code 120917X. [Lot codes on boxes and packaging contain a lot code in the following format: 120917X where 12 represents the year (2012), 09 represents the month (September), 17 represents the day of the month, and X represents the manufacturing shift code (1, 2, 3, 4,5,6 or 9)].",".",,"ConMed received complaints of some devices which had broken through the seal of the sterile pouch. ConMed confirmed instances where the pouch seal was compromised on the affected products. In no instance has it been reported to ConMed that a compromise in the sterile barrier has resulted in illness or injury. The compromised seals were discovered prior to use.",12/27/2012,"12/27/2012",1/30/2013,"01/30/2013"
"Devices",63981,"Ongoing","ConMed Corporation","Utica","NY","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Worldwide Distribution - USA (nationwide) Puerto Rico and internationally to Belgium, Colombia, Czech Republic, Dubai, Guatamala, Hong Kong, India, Israel, Italy, Japan, Kenya, Kuwait, Malaysia, Mexico, New Zealand, Norway, Oman, Pakistan, Portugal, Saudi Arabia, Thailand, and Uruguay.","Z-0737-2013","Class II","UltraClean(R) Accessory Electrode 4 inch Coated Blade with Extended Insulation, REF/Catalog No. 139112EXT, Single Use, Sterile, Rx ONLY -- CONMED CORPORATION 525 FRENCH ROAD, UTICA, NY 13502-5994 --- Product Name: Electrosurgery Active Electrodes and Accessories; Common First Name: Electrosurgical, Cutting and Coagulation and Accessories. MDL D085930. The ESP Electrode blades are components for electrosurgical pencils. The electrodes provide specific shapes and lengths to allow the clinician to utilize these different configurations for various clinical applications. The UltraClean version differs from the Universal as it has a ''non-stick'' finish. The Single Use ABC Nozzle is intended for use in the operating room for any procedure in which an electrosurgical generator would be used, i.e. for the surgical removal of tissue and for the control of bleeding. ","Beginning Lot Code 120628X, Ending Lot Code 120917X. [Lot codes on boxes and packaging contain a lot code in the following format: 120917X where 12 represents the year (2012), 09 represents the month (September), 17 represents the day of the month, and X represents the manufacturing shift code (1, 2, 3, 4,5,6 or 9)].",".",,"ConMed received complaints of some devices which had broken through the seal of the sterile pouch. ConMed confirmed instances where the pouch seal was compromised on the affected products. In no instance has it been reported to ConMed that a compromise in the sterile barrier has resulted in illness or injury. The compromised seals were discovered prior to use.",12/27/2012,"12/27/2012",1/30/2013,"01/30/2013"
"Devices",63981,"Ongoing","ConMed Corporation","Utica","NY","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Worldwide Distribution - USA (nationwide) Puerto Rico and internationally to Belgium, Colombia, Czech Republic, Dubai, Guatamala, Hong Kong, India, Israel, Italy, Japan, Kenya, Kuwait, Malaysia, Mexico, New Zealand, Norway, Oman, Pakistan, Portugal, Saudi Arabia, Thailand, and Uruguay.","Z-0734-2013","Class II","UltraClean(R) Accessory Electrode 6 inch Coated Needle with Extended Insulation, REF/Catalog No. 139108, Single Use, Sterile, Rx ONLY -- CONMED CORPORATION 525 FRENCH ROAD, UTICA, NY 13502-5994 --- Product Name: Electrosurgery Active Electrodes and Accessories; Common First Name: Electrosurgical, Cutting and Coagulation and Accessories. MDL D085930. The ESP Electrode blades are components for electrosurgical pencils. The electrodes provide specific shapes and lengths to allow the clinician to utilize these different configurations for various clinical applications. The UltraClean version differs from the Universal as it has a ''non-stick'' finish. The Single Use ABC Nozzle is intended for use in the operating room for any procedure in which an electrosurgical generator would be used, i.e. for the surgical removal of tissue and for the control of bleeding. ","Beginning Lot Code 120628X, Ending Lot Code 120917X. [Lot codes on boxes and packaging contain a lot code in the following format: 120917X where 12 represents the year (2012), 09 represents the month (September), 17 represents the day of the month, and X represents the manufacturing shift code (1, 2, 3, 4,5,6 or 9)].",".",,"ConMed received complaints of some devices which had broken through the seal of the sterile pouch. ConMed confirmed instances where the pouch seal was compromised on the affected products. In no instance has it been reported to ConMed that a compromise in the sterile barrier has resulted in illness or injury. The compromised seals were discovered prior to use.",12/27/2012,"12/27/2012",1/30/2013,"01/30/2013"
"Devices",63981,"Ongoing","ConMed Corporation","Utica","NY","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Worldwide Distribution - USA (nationwide) Puerto Rico and internationally to Belgium, Colombia, Czech Republic, Dubai, Guatamala, Hong Kong, India, Israel, Italy, Japan, Kenya, Kuwait, Malaysia, Mexico, New Zealand, Norway, Oman, Pakistan, Portugal, Saudi Arabia, Thailand, and Uruguay.","Z-0732-2013","Class II","UltraClean(R) Accessory Electrode 1 inch Coated Needle with Extended Insulation, REF/Catalog No. 139105EXT, Single Use, Sterile, Rx ONLY -- CONMED CORPORATION 525 FRENCH ROAD, UTICA, NY 13502-5994 --- Product Name: Electrosurgery Active Electrodes and Accessories; Common First Name: Electrosurgical, Cutting and Coagulation and Accessories. MDL D085930. The ESP Electrode blades are components for electrosurgical pencils. The electrodes provide specific shapes and lengths to allow the clinician to utilize these different configurations for various clinical applications. The UltraClean version differs from the Universal as it has a ''non-stick'' finish. The Single Use ABC Nozzle is intended for use in the operating room for any procedure in which an electrosurgical generator would be used, i.e. for the surgical removal of tissue and for the control of bleeding. ","Beginning Lot Code 120628X, Ending Lot Code 120917X. [Lot codes on boxes and packaging contain a lot code in the following format: 120917X where 12 represents the year (2012), 09 represents the month (September), 17 represents the day of the month, and X represents the manufacturing shift code (1, 2, 3, 4,5,6 or 9)].",".",,"ConMed received complaints of some devices which had broken through the seal of the sterile pouch. ConMed confirmed instances where the pouch seal was compromised on the affected products. In no instance has it been reported to ConMed that a compromise in the sterile barrier has resulted in illness or injury. The compromised seals were discovered prior to use.",12/27/2012,"12/27/2012",1/30/2013,"01/30/2013"
"Devices",63981,"Ongoing","ConMed Corporation","Utica","NY","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Worldwide Distribution - USA (nationwide) Puerto Rico and internationally to Belgium, Colombia, Czech Republic, Dubai, Guatamala, Hong Kong, India, Israel, Italy, Japan, Kenya, Kuwait, Malaysia, Mexico, New Zealand, Norway, Oman, Pakistan, Portugal, Saudi Arabia, Thailand, and Uruguay.","Z-0731-2013","Class II","UltraClean(R) Accessory Electrode 1 inch Coated Blade with Extended Insulation, REF/Catalog No. 139104EXT, Single Use, Sterile, Rx ONLY -- CONMED CORPORATION 525 FRENCH ROAD, UTICA, NY 13502-5994 --- Product Name: Electrosurgery Active Electrodes and Accessories; Common First Name: Electrosurgical, Cutting and Coagulation and Accessories. MDL D085930. The ESP Electrode blades are components for electrosurgical pencils. The electrodes provide specific shapes and lengths to allow the clinician to utilize these different configurations for various clinical applications. The UltraClean version differs from the Universal as it has a ''non-stick'' finish. The Single Use ABC Nozzle is intended for use in the operating room for any procedure in which an electrosurgical generator would be used, i.e. for the surgical removal of tissue and for the control of bleeding.","Beginning Lot Code 120628X, Ending Lot Code 120917X. [Lot codes on boxes and packaging contain a lot code in the following format: 120917X where 12 represents the year (2012), 09 represents the month (September), 17 represents the day of the month, and X represents the manufacturing shift code (1, 2, 3, 4,5,6 or 9)].",".",,"ConMed received complaints of some devices which had broken through the seal of the sterile pouch. ConMed confirmed instances where the pouch seal was compromised on the affected products. In no instance has it been reported to ConMed that a compromise in the sterile barrier has resulted in illness or injury. The compromised seals were discovered prior to use.",12/27/2012,"12/27/2012",1/30/2013,"01/30/2013"
"Devices",63981,"Ongoing","ConMed Corporation","Utica","NY","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Worldwide Distribution - USA (nationwide) Puerto Rico and internationally to Belgium, Colombia, Czech Republic, Dubai, Guatamala, Hong Kong, India, Israel, Italy, Japan, Kenya, Kuwait, Malaysia, Mexico, New Zealand, Norway, Oman, Pakistan, Portugal, Saudi Arabia, Thailand, and Uruguay.","Z-0719-2013","Class II","ELECTROLASE(R) HYFRECATOR(R) ELECTRODES - BLUNT, Disposable Hyfrecator(R) Tips, REF/Catalog No. 7-101-8CS, Sterile, Rx ONLY -- CONMED CORPORATION 525 FRENCH RD., UTICA, NY 13502-5994 --- Product Name: Electrosurgery Active Electrodes and Accessories; Common First Name: Electrosurgical, Cutting and Coagulation and Accessories. MDL 092250. The Electrolase Sterile Disposable Electrodes are intended to be used as active RF electrodes for desiccation, fulguration and coagulation. The ESP Electrode blades are components for electrosurgical pencils. The electrodes provide specific shapes and lengths to allow the clinician to utilize these different configurations for various clinical applications. The UltraClean version differs from the Universal as it has a ''non-stick'' finish. The Single Use ABC Nozzle is intended for use in the operating room for any procedure in which an electrosurgical generator would be used, i.e. for the surgical removal of tissue and for the control of bleeding. ","Beginning Lot Code 120628X, Ending Lot Code 120917X. [Lot codes on boxes and packaging contain a lot code in the following format: 120917X where 12 represents the year (2012), 09 represents the month (September), 17 represents the day of the month, and X represents the manufacturing shift code (1, 2, 3, 4,5,6 or 9)].",".",,"ConMed received complaints of some devices which had broken through the seal of the sterile pouch. ConMed confirmed instances where the pouch seal was compromised on the affected products. In no instance has it been reported to ConMed that a compromise in the sterile barrier has resulted in illness or injury. The compromised seals were discovered prior to use.",12/27/2012,"12/27/2012",1/30/2013,"01/30/2013"
"Food",63982,"Ongoing","Chocolate Decadence","Eugene","OR","US","Voluntary: Firm Initiated","Telephone","Product was distributed in Arkansas California, Florida, Georgia, Indiana, Michigan, Minnesota, New Hampshire, New Jersey, New Mexico, New York, Oregon, Virginia, Washington, West Virginia, Wisconsin,","F-0940-2013","Class II","Chocolate Covered Coconut Balls is packaged in either 2-ounce packages (2 pieces per package) or in 0.5 lb and 1 lb. boxes. The 2-ounce package has a UPC 19815 90007 8. There is no UPC for 0.5 lb. and 1 lb. packages. The product is labeled in parts: ''***Chocolate Covered Coconut Balls***CHOCOLATE DECADENCE***Net Wt. 2oz (56.7g)***INGREDIENTS: Semi-sweet chocolate (sugar,","None",".","46/2 oz. packages; 5/1 lb. boxes; and 2/0.5 lbs boxes","There is a potential of cross contamination with peanuts. The Chocolate Covered Coconut Balls were dipped in the same pot of melting chocolate that was used to make product containing peanut butter.",12/26/2012,"12/26/2012",2/6/2013,"02/06/2013"
"Biologics",63983,"Terminated","American Red Cross Blood Services Tennessee Valley Region","Nashville","TN","US","Voluntary: Firm Initiated","Other","California","B-0750-13","Class III","Blood and Blood Products for Reprocessing","019LJ61879",,"1","Bloood product, collected from an ineligible donor, was distributed.",10/31/2012,"10/31/2012",2/13/2013,"02/13/2013"
"Biologics",63984,"Terminated","LifeShare Community Blood Services","Elyria","OH","US","Voluntary: Firm Initiated","Letter","Ohio","B-0860-13","Class II","Red Blood Cells Leukocytes Reduced","W043812010523; ",".","1","Blood products, collected from a donor who reported travel to a malarial endemic area, were distributed",12/7/2012,"12/07/2012",4/10/2013,"04/10/2013"
"Biologics",63984,"Terminated","LifeShare Community Blood Services","Elyria","OH","US","Voluntary: Firm Initiated","Letter","Ohio","B-0861-13","Class II","Platelets Pooled Leukocytes Reduced","W043812902467; ",".","1","Blood products, collected from a donor who reported travel to a malarial endemic area, were distributed",12/7/2012,"12/07/2012",4/10/2013,"04/10/2013"
"Biologics",63985,"Terminated","Florida's Blood Centers, Inc.","Orlando","FL","US","Voluntary: Firm Initiated","Letter","Florida","B-0856-13","Class II","Plasma Frozen within 24 hours (FP24)","W038112278518; ",".","1","Blood product, collected from a donor considered to be at increased risk for variant Creutzfeldt-Jakob Disease (vCJD), was distributed.",11/21/2012,"11/21/2012",4/10/2013,"04/10/2013"
"Biologics",63986,"Terminated","Community Blood Centers of South Florida, Inc.","Hialeah","FL","US","Voluntary: Firm Initiated","Telephone","Florida","B-0849-13","Class II","Platelets Pooled Leukocytes Reduced","W036812844471; ",".","1","Blood products, collected from a donor whose suitability to donate was not adequately determined, were distributed.",12/5/2012,"12/05/2012",4/10/2013,"04/10/2013"
"Biologics",63986,"Terminated","Community Blood Centers of South Florida, Inc.","Hialeah","FL","US","Voluntary: Firm Initiated","Telephone","Florida","B-0848-13","Class II","Red Blood Cells","W036812530959; ",".","1","Blood products, collected from a donor whose suitability to donate was not adequately determined, were distributed.",12/5/2012,"12/05/2012",4/10/2013,"04/10/2013"
"Biologics",63986,"Terminated","Community Blood Centers of South Florida, Inc.","Hialeah","FL","US","Voluntary: Firm Initiated","Telephone","Florida","B-0850-13","Class II","Fresh Frozen Plasma","W036812530959; ",".","3","Blood products, collected from a donor whose suitability to donate was not adequately determined, were distributed.",12/5/2012,"12/05/2012",4/10/2013,"04/10/2013"
"Biologics",63987,"Terminated","Central Blood Bank","Pittsburgh","PA","US","Voluntary: Firm Initiated","Telephone","Pennsylvania","B-0885-13","Class III","Fresh Frozen Plasma","W084312002713; ",".","1","Blood products, collected from a paid donor but incorrectly labeled with the ''volunteer donor'' classification, were distributed.",10/29/2012,"10/29/2012",4/10/2013,"04/10/2013"
"Biologics",63987,"Terminated","Central Blood Bank","Pittsburgh","PA","US","Voluntary: Firm Initiated","Telephone","Pennsylvania","B-0884-13","Class III","Platelets","W084312002713; ",".","1","Blood products, collected from a paid donor but incorrectly labeled with the ''volunteer donor'' classification, were distributed.",10/29/2012,"10/29/2012",4/10/2013,"04/10/2013"
"Biologics",63987,"Terminated","Central Blood Bank","Pittsburgh","PA","US","Voluntary: Firm Initiated","Telephone","Pennsylvania","B-0883-13","Class III","Red Blood Cells","W084312002713; ",".","1","Blood products, collected from a paid donor but incorrectly labeled with the ''volunteer donor'' classification, were distributed.",10/29/2012,"10/29/2012",4/10/2013,"04/10/2013"
"Drugs",63988,"Ongoing","Advance Pharmaceutical Inc","Holtsville","NY","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Nationwide","D-601-2013","Class I","Rugby NATURAL IRON SUPPLEMENT Ferrous Sulfate, 5 gr (325 mg), 100 TABLETS, Mfd for: RUGBY LABORATORIES, INC. DULUTH, GEORGIA 30097 UPC 0 0536-5890-013","Lot 12G468, Exp. 07/2014.",".","19,944 bottles ","Labeling; Label Mixup; bottles of Ferrous Sulfate actually contains Meclizine HCl (indicated for motion sickness)",12/28/2012,"12/28/2012",6/19/2013,"06/19/2013"
"Veterinary",63989,"Ongoing","ADM Alliance Nutrition, Inc.","Bluffton","IN","US","Voluntary: Firm Initiated","Telephone","IN and OH Only","V-138-2013","Class III","ADM Alliance Nutrition Meat Goat Power 16%","Product #80865AZN24Lot #BF23512 ",,"120-50lb bags","During an FDA inspection, the ADM Alliance Nutrition Meat Goat Power 16% (80865AZN), was run through the firm's mixer directly after lot # BF23512 of the recalled sheep feed. The Retention sample was found to have 46.4 ppm copper when the label states 25ppm-35ppm.",12/28/2012,"12/28/2012",3/6/2013,"03/06/2013"
"Devices",63991,"Ongoing","Mizuho OSI","Union City","CA","US","Voluntary: Firm Initiated","Letter","USA Distribution -- Worldwide Distribution including the states of AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, SC, TN, TX, UT, VA, WA, WI, WV and WY., and the countries of Australia, Canada, Egypt, Finland, France, Germany, China, Israel, Italy, Japan, Netherlands, New Zealand, P.R. China, Saudi Arabia, Singapore, Slovenia, South Korea, Spain, Taiwan R.O.C.,UAE and UK.","Z-0810-2013","Class II","Mizuho Orthopedic Table, model 5855, sub assembly 5855-901 Orthopedic Table Spar.","Table model 5855, sub assembly 5855-901 Orthopedic Table Spar manufactured between 1996 and 2007.",,"869 devices","Possible instability of Orthopedic Table Top. If the epoxy bond fails, the aluminum plug may migrate out of the carbon fiber tube. If this occurs, the Orthopedic Table Spar may need to be replaced to ensure stability of the Orthopedic Table Top.",12/17/2012,"12/17/2012",2/20/2013,"02/20/2013"
"Biologics",63992,"Terminated","Hoxworth Blood Center UC Medical Center","Cincinnati","OH","US","Voluntary: Firm Initiated","Telephone","Ohio","B-0855-13","Class II","Fresh Frozen Plasma","W037711174629; ",".","1","Blood product, collected from a donor considered to be at increased risk for variant Creutzfeldt-Jakob Disease (vCJD), was distributed.",10/5/2012,"10/05/2012",4/10/2013,"04/10/2013"
"Food",63995,"Ongoing","Dollar Tree Distribution, Inc.","Chesapeake","VA","US","Voluntary: Firm Initiated","E-Mail","Nationwide and Canada","F-0883-2013","Class II","Candy Canes, Cherry Flavor, 5 oz boxes, packed 12 candy canes/box, and labeled in part ***Distributed by Greenbriar International, Inc., Chesapeake, VA 23320, MADE IN CHINA***","Batch number: 01880-001 120504",".","1,257,120 boxes","Candy product may contain metal and/or plastic pieces embedded in the candy.",12/21/2012,"12/21/2012",1/23/2013,"01/23/2013"
"Food",63995,"Ongoing","Dollar Tree Distribution, Inc.","Chesapeake","VA","US","Voluntary: Firm Initiated","E-Mail","Nationwide and Canada","F-0882-2013","Class II","Candy Canes, Peppermint Flavor, 5 oz boxes, packed 12 individually candy canes/box, and labeled in part ***Distributed by Greenbriar International, Inc., Chesapeake, VA 23320, MADE IN CHINA***","Batch number: YT-0112003 01880-001 120521 01880-001 120605",".","3,147,956 boxes","Candy product may contain metal and/or plastic pieces embedded in the candy.",12/21/2012,"12/21/2012",1/23/2013,"01/23/2013"
"Food",63996,"Ongoing","Jerusalem Manufacturing Natural Foods & Wholesalers, Inc.","Dearborn","MI","US","Voluntary: Firm Initiated","Telephone","MI Only (Dexter and Clinton Twp)","F-0948-2013","Class I","Kinnikinnick Foods Brand Frozen Pie Crusts, 290g/10 ounces. 2 crusts per box, 6 boxes per case","Product code 620133006009 and lot BB2013DE13",".","80 cs","Kinnikinnick Foods Inc., a Canadian manufacturer notifed Jerusalem Manufacturing Natural Food and Wholesalers, Inc. in Dearborn, MI to recall the Kinnikinnick Foods Brand Frozen Pies, 290g/10 ounces. 2 crusts per box, 6 boxes per case due to EGG not declared on the label.",12/31/2012,"12/31/2012",2/6/2013,"02/06/2013"
"Devices",63997,"Ongoing","Roche Molecular Systems, Inc.","Branchburg","NJ","US","Voluntary: Firm Initiated","E-Mail","Worldwide Distribution - Foreign (22 EU countries - Austria, Belgium, Bulgaria, Croatia, Cypress, Czech Republic, Denmark, Germany, Finland, France, Greenland, Hungary, Iceland, Italy, Luxembourg, Netherland, Norway, Sweden, Switzerland, Spain, Turkey, UK); (41 Rest of World countries - See Attachment for full country distribution + Japan, Portugal and Mexico)","Z-0762-2013","Class II","COBAS TaqMan Mycobacteria tuberculosis (MTB) Test FOR IN VITRO DIAGNOSTIC USE.","Material Number: CE-IVD: 04803531190 Kit, 05574455190 TDF; JPN-IVD: 04653360190 Kit, 05574447190 TDF. Lot/Serial Number: CE-IVD: All Kits, JPN-IVD: All Kits.",".","335 CE-IVD TDFs; 48 JPN-IVD TDFs","The COBAS TaqMan MTB Test Definition Files (TDF) v3.0, for both CE-IVD and JPN-IVD tests, being used with AMPLILINK software version 3.3 series and COBAS TaqMan MTB Test Kits, both CE-IVD and JPN-IVD, have an incorrect Target Elbow Max cutoff value of 48 creating the potential for false negative results to be generated for patient samples with Target Elbows in the range of 48 to 50.",11/28/2012,"11/28/2012",2/6/2013,"02/06/2013"
"Food",63998,"Ongoing","United National Foods (Unfi)","Aurora","CO","US","Voluntary: Firm Initiated","Letter","Distributed to UNFI distribution centers located in WA, CA, CO, and TX.","F-0865-2013","Class I","Kinnikinnick Pie Crust Glutent Free (frozen) weight 290 g/ 10 oz Qty/Pkg: 2, UPC 620133006229, Kinnikinnick Foods 10940 120 Street, Edmonton, AB Canada.","US distribution: BB2013NO30; BB2013DE12; BB2013DE13; BB2013DE14; BB2013DE17.",".","56 x 10 oz packages","UNFI Aurora, Colorado is recalling certain Kinnikinnick Pie Crusts (frozen) because they were notified by the manufacturer, Kinnikinnick Foods (Alberta, Canada) that the products contain eggs and are not identified in the finished product labeling.",12/28/2012,"12/28/2012",1/16/2013,"01/16/2013"
"Devices",64000,"Ongoing","Beckman Coulter Inc.","Brea","CA","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution-USA (nationwide) and the countries of Argentina, Australia, Austria, Brazil, China, Czech Republic, France, Germany, Hungary, India, Ireland, Israel, Italy, Korea Republic, Malaysia, Netherlands, Russian Federation, Spain, Switzerland, Taiwan, Turkey, United Kingdom, and Viet Nam.","Z-0913-2013","Class II","Beckman Coulter AU5800 Clinical Chemistry Analyzer. An automated chemistry analyzer that measures analytes such as Glucose, Magnesium, and Potassium.","All serial numbers / Multiple manufacture dates. Part# Item# ================ A94907 AU5811-02 A94912 AU5821-02 A94917 AU5831-02 A94922 AU5841-02 A94908 AU5811-03 A94913 AU5821-03 A94918 AU5831-03 A94923 AU5841-03 A94909 AU5811-04 A94914 AU5821-04 A94919 AU5831-04 A94924 AU5841-04 A94910 AU5811-06 A94915 AU5821-06 A94920 AU5831-06 A94925 AU5841-06",,"28 in U.S.; 4 Canada; 318 to other foreign countries.","Due to a software data storage limitation which only occurs under certain conditions, measurements of the Reagent Blank (RB) or Calibration (CAL) sample results are not saved and the software reverts to a previously stored, acceptable RB/CAL result. ",11/28/2012,"11/28/2012",3/13/2013,"03/13/2013"
"Drugs",64001,"Ongoing","Hospira Inc.","Lake Forest","IL","US","Voluntary: Firm Initiated","Letter","Nationwide","D-183-2013","Class II"," 0.9% Sodium Chloride Injection USP, 100 mL Hospira, Inc., Lake Forest, IL 60045 NDC 0409-7984-23,","Lot Number 02-117-JT Exp. 02/13",,"325,056 bags","Lack of Assurance of Sterility: There is the potential for solution to leak from the administrative port to the fill tube seal.",1/8/2013,"01/08/2013",3/13/2013,"03/13/2013"
"Biologics",64002,"Terminated","Indiana Lions Eye and Tissue Transplant Bank","Indianapolis","IN","US","Voluntary: Firm Initiated","Telephone","Indiana","B-0728-13","Class II","Cornea","CN100823OD",,"1","Human Cornea, recovered in a manner that increased the risk of the introduction, transmission, or spread of communicable disease, was distributed.",9/26/2012,"09/26/2012",2/13/2013,"02/13/2013"
"Devices",64004,"Ongoing","Biomet, Inc.","Warsaw","IN","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution - USA including CA, FL, IL, AL, OH, KY, TX , and Internationally to Australia, Columbia, Mexico, Netherlands, and Chile.","Z-0753-2013","Class II","TUNNELOC ROUND HEAD INTERFERENCE SCREW 8MMX25MM Biomet Sports Medicine manufactures a variety of internal fixation devices intended to aid in arthroscopic and orthopedic reconstructive procedures requiring soft tissue fixation, due to injury or degenerative disease. Implants used for this application include: screws, washers, anchors, pins, and suture. Interference Screws and Set Screws are intended for use in fixation of patellar bone-tendon-bone grafts in ACL reconstruction.","Catalog Number: 909668 Lot Number Identification: 716710",".","44 units distributed","Thru hole at the tip of the screw is undersized.",1/3/2013,"01/03/2013",2/6/2013,"02/06/2013"
"Food",64006,"Ongoing","Local Baking, Co, Inc. T/A Joey's Fine Foods","Newark","NJ","US","Voluntary: Firm Initiated","Telephone","New York and New Jersey","F-0881-2013","Class II","JOEY'S GOURMET LEMON CAKE; NET WT 3 oz. (85 g); UPC 026104613403; Joey's Fine Foods, Inc., Newark, NJ 07104; 973-482-1400","All lots",".","160 cases (12, 3-oz. units in each)","Product contains undeclared FD&C Yellow #5.",12/6/2012,"12/06/2012",1/23/2013,"01/23/2013"
"Devices",64007,"Ongoing","Terumo Cardiovascular Systems Corporation","Ann Arbor","MI","US","Voluntary: Firm Initiated","Letter","Nationwide and worldwide: AL , AR , AZ , CA , CO , CT , FL , GA , HI , IA , IL , IN , KS , KY , LA , MA , ME , MI, MO , NC , ND , NV , NY , OH , OK , PA , SD , TN , TX , UT , VA , WA , and WI. Bahrain, BRAZIL, CANADA, CHILE, Honduras, Singapore, Taiwan, Trinidad and Tobago, and UNITED ARAB EMIRATES (UAE).","Z-0666-2013","Class II","Sarns flexible arterial cannula, 6.7 mm (20Fr) OD with 3/8 in. connector, suture ring, 9.5 in (24 cm) long The Sarns High Flow Aortic Arch Cannula and Sarns Flexible Arterial Cannulae are indicated for use in perfusion of the ascending aorta during cardiopulmonary bypass surgery","Lot number: 0677286 and Catalog number: 13010.",".","6830 total units for all products","Flexible Arterial Cannula and High-Flow Aortic Arch Cannula connectors were identified to contain flash on the exterior of the cannula connector that exceeded established specifications. Because the flash has the potential to detach in the operative field, TCVS has decided to remove all affected lots that were manufactured with the affected connector part.",1/7/2013,"01/07/2013",1/23/2013,"01/23/2013"
"Devices",64007,"Ongoing","Terumo Cardiovascular Systems Corporation","Ann Arbor","MI","US","Voluntary: Firm Initiated","Letter","Nationwide and worldwide: AL , AR , AZ , CA , CO , CT , FL , GA , HI , IA , IL , IN , KS , KY , LA , MA , ME , MI, MO , NC , ND , NV , NY , OH , OK , PA , SD , TN , TX , UT , VA , WA , and WI. Bahrain, BRAZIL, CANADA, CHILE, Honduras, Singapore, Taiwan, Trinidad and Tobago, and UNITED ARAB EMIRATES (UAE).","Z-0667-2013","Class II","Sarns flexible arterial cannula, 7.3 mm (22 Fr) OD with 3/8in connector, suture ring, 9.5in (24 cm) long The Sarns High Flow Aortic Arch Cannula and Sarns Flexible Arterial Cannulae are indicated for use in perfusion of the ascending aorta during cardiopulmonary bypass surgery","Lot number: 0677284 and Catalog number: 13020",".","6830 total all products","Flexible Arterial Cannula and High-Flow Aortic Arch Cannula connectors were identified to contain flash on the exterior of the cannula connector that exceeded established specifications. Because the flash has the potential to detach in the operative field, TCVS has decided to remove all affected lots that were manufactured with the affected connector part.",1/7/2013,"01/07/2013",1/23/2013,"01/23/2013"
"Devices",64007,"Ongoing","Terumo Cardiovascular Systems Corporation","Ann Arbor","MI","US","Voluntary: Firm Initiated","Letter","Nationwide and worldwide: AL , AR , AZ , CA , CO , CT , FL , GA , HI , IA , IL , IN , KS , KY , LA , MA , ME , MI, MO , NC , ND , NV , NY , OH , OK , PA , SD , TN , TX , UT , VA , WA , and WI. Bahrain, BRAZIL, CANADA, CHILE, Honduras, Singapore, Taiwan, Trinidad and Tobago, and UNITED ARAB EMIRATES (UAE).","Z-0668-2013","Class II","Sarns flexible arterial cannula, 8.0 mm (24 Fr) with 3/8in connector, suture ring, 9.5in (24 cm) long The Sarns High Flow Aortic Arch Cannula and Sarns Flexible Arterial Cannulae are indicated for use in perfusion of the ascending aorta during cardiopulmonary bypass surgery","Lot number: 067728 and 0681074 and Catalog number: 13030",".","6830 total all products","Flexible Arterial Cannula and High-Flow Aortic Arch Cannula connectors were identified to contain flash on the exterior of the cannula connector that exceeded established specifications. Because the flash has the potential to detach in the operative field, TCVS has decided to remove all affected lots that were manufactured with the affected connector part.",1/7/2013,"01/07/2013",1/23/2013,"01/23/2013"
"Devices",64007,"Ongoing","Terumo Cardiovascular Systems Corporation","Ann Arbor","MI","US","Voluntary: Firm Initiated","Letter","Nationwide and worldwide: AL , AR , AZ , CA , CO , CT , FL , GA , HI , IA , IL , IN , KS , KY , LA , MA , ME , MI, MO , NC , ND , NV , NY , OH , OK , PA , SD , TN , TX , UT , VA , WA , and WI. Bahrain, BRAZIL, CANADA, CHILE, Honduras, Singapore, Taiwan, Trinidad and Tobago, and UNITED ARAB EMIRATES (UAE).","Z-0669-2013","Class II","Sarns high-flow aortic arch cannula, 5.2 mm (16 Fr) OD with 3/8in connector, 7.5in (19 cm) long The Sarns High Flow Aortic Arch Cannula and Sarns Flexible Arterial Cannulae are indicated for use in perfusion of the ascending aorta during cardiopulmonary bypass surgery","Lot number: 0677294, 0680693, 0682187 and Catalog number: 12315",".","6830 total all products","Flexible Arterial Cannula and High-Flow Aortic Arch Cannula connectors were identified to contain flash on the exterior of the cannula connector that exceeded established specifications. Because the flash has the potential to detach in the operative field, TCVS has decided to remove all affected lots that were manufactured with the affected connector part.",1/7/2013,"01/07/2013",1/23/2013,"01/23/2013"
"Devices",64007,"Ongoing","Terumo Cardiovascular Systems Corporation","Ann Arbor","MI","US","Voluntary: Firm Initiated","Letter","Nationwide and worldwide: AL , AR , AZ , CA , CO , CT , FL , GA , HI , IA , IL , IN , KS , KY , LA , MA , ME , MI, MO , NC , ND , NV , NY , OH , OK , PA , SD , TN , TX , UT , VA , WA , and WI. Bahrain, BRAZIL, CANADA, CHILE, Honduras, Singapore, Taiwan, Trinidad and Tobago, and UNITED ARAB EMIRATES (UAE).","Z-0671-2013","Class II","Sarns high-flow aortic arch cannula, 6.5 mm (20 Fr) OD with 3/8in connector, 11in (28 cm) long, with X coating surface The Sarns High Flow Aortic Arch Cannula and Sarns Flexible Arterial Cannulae are indicated for use in perfusion of the ascending aorta during cardiopulmonary bypass surgery","Lot number: 0677299 and Catalog number: 12325X",".","6830 total all products","Flexible Arterial Cannula and High-Flow Aortic Arch Cannula connectors were identified to contain flash on the exterior of the cannula connector that exceeded established specifications. Because the flash has the potential to detach in the operative field, TCVS has decided to remove all affected lots that were manufactured with the affected connector part.",1/7/2013,"01/07/2013",1/23/2013,"01/23/2013"
"Devices",64007,"Ongoing","Terumo Cardiovascular Systems Corporation","Ann Arbor","MI","US","Voluntary: Firm Initiated","Letter","Nationwide and worldwide: AL , AR , AZ , CA , CO , CT , FL , GA , HI , IA , IL , IN , KS , KY , LA , MA , ME , MI, MO , NC , ND , NV , NY , OH , OK , PA , SD , TN , TX , UT , VA , WA , and WI. Bahrain, BRAZIL, CANADA, CHILE, Honduras, Singapore, Taiwan, Trinidad and Tobago, and UNITED ARAB EMIRATES (UAE).","Z-0670-2013","Class II","Sarns high-flow aortic arch cannula, 6.5 mm (20 Fr) OD with 3/8in connector, 11in (28 cm) long The Sarns High Flow Aortic Arch Cannula and Sarns Flexible Arterial Cannulae are indicated for use in perfusion of the ascending aorta during cardiopulmonary bypass surgery","Lot number: 0680122, 0680751and Catalog number: 12325",".","6830 total all products","Flexible Arterial Cannula and High-Flow Aortic Arch Cannula connectors were identified to contain flash on the exterior of the cannula connector that exceeded established specifications. Because the flash has the potential to detach in the operative field, TCVS has decided to remove all affected lots that were manufactured with the affected connector part.",1/7/2013,"01/07/2013",1/23/2013,"01/23/2013"
"Devices",64008,"Ongoing","Becton Dickinson & Co.","Sparks","MD","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution - USA (nationwide) and internationally to Australia, Belgium, Canada, South Korea, Taiwan, Hong Kong, Japan, Mexico, and Singapore.","Z-0739-2013","Class II","BBL(TM) Fildes Enrichment, catalog number 211866, 10 tubes/pack, labeled in part ***Becton Dickinson and Company, Sparks, MD 21152 USA*** Intended Use: Fildes Enrichment may be used to enrich a variety of media for the cultivation of various microorganisms. Fildes Enrichment is a peptic digest of sheep blood used to enhance the growth of fastidious organisms. It may be added to Tryptic/Trypticase Soy Broth or Agar in final concentration of 5% for cultivation of Haemophilus influenzae. Fildes Enrichment is intended to be a rich source of growth factors stimulatory to various microorganisms, including the X (hemin) and V (nicotinamide adenine dinucleotide, NAD) factors necessary for the growth of Haemophilus influenzae. Labeling: For Laboratory Use. ","Lot/Exp 2079066/ EXP March 6, 2013 2096375/ EXP March 22, 2013 2216092/ EXP July 20, 2013 2227271/ EXP Auqust 2, 2013 ",".","11,710 tubes","Enrichment media intended to enhance the cultivation of various microorganisms may fail to support the growth of Haemophilus species.",12/10/2012,"12/10/2012",2/6/2013,"02/06/2013"
"Food",64009,"Ongoing","Gilster-Mary Lee Corp.","Chester","IL","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Distribution made to VA, KY and TN.","F-0942-2013","Class I","Food Club Chocolate Chunk Brownie Mix, packaged in 21.5-oz. boxes, UPC# 36800-13486, distributed by TOPCO Associates LLC, Skokie, IL.","NOV 28 13 DO2, use by 11/28/2013",".","25/12/21.5-oz carton cases","The product contains walnuts and it was packaged in the wrong carton. Due to the mis-packaging the ingredient label does not have walnuts listed.",1/2/2013,"01/02/2013",2/6/2013,"02/06/2013"
"Devices",64010,"Ongoing","Becton Dickinson & Company","Franklin Lakes","NJ","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution-USA (nationwide) and the countries of Canada, India, Japan, Nepal, Malaysia, Singapore, Brazil, Costa Rica, and Virgin Islands.","Z-0756-2013","Class II","BD Vacutainer Buffered Sodium Citrate (9NC) Plus Blood Collection Tubes; Sterile; IVD; REF 363083; 13 X 75 mm, 2.7 mL","Lot No. 2180434; Expiration Date: April 2013",".","2,944,700 units","BD is conducting a recall of the BD Vacutainer 2.7mL Plus Citrate Blood Collection Tube due to extended Partial Thromboplastin Time (aPTT) test results reported in two customer complaints.",11/12/2012,"11/12/2012",2/6/2013,"02/06/2013"
"Food",64011,"Ongoing","EonNutra, LLC","Colorado Springs","CO","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Nationwide, AR, CA, CO, FL, GA, IO, MI, MO, NC, ND, NE, NJ, SC, TN, TX, UT, WI","F-0937-2013","Class II","Growth Factor Complex 200 GFC 200, Dietary Supplement 2 Fl Oz, Manufactured for: Soto Supplements P.O. Box 75774 Colorado Springs, CO 80237, Instructions: Place drops under your tongue for 2 min then swallow. Do not eat or drink for 15 min. Only approved for distribution from Authorized Distributors/Retailers, pharmaceutical laboratories and governmental research facilities.","SRK91512; SRK92112; SRK92512; SRK102312; SRK11412; SRK111912.",".","199 x 2 oz bottles","Eon Nutra, LLC is recalling certain SOTO Supplements GFC 200 because the liquid dietary supplement products may be contaminated with various types of bacteria.",1/2/2013,"01/02/2013",2/6/2013,"02/06/2013"
"Food",64012,"Ongoing","S & M International Inc","Bayonne","NJ","US","Voluntary: Firm Initiated","Telephone","NY, MI, PA, KY, West Virginia","F-0884-2013","Class II","Yangsheng Eggs Preserved Duck Eggs Content 6 pcs Net Wt: approx 12.69 oz (360g) S&M (USA) Enterprise Corp Rm3 8/F., Yuexiu Bldg., 160-174 Lockhart Road, Wan Chai, HK Distributed by : S & M Int'l Inc 100 Pulaski ST., Bayonne NJ 07002 Product of China UPC 6949682803551","Lot YS12-02A",".","855 cases (24 individual packages of eggs)","Preserved Duck Eggs do not meet pH standard of 10 for boiled/preserved eggs.",12/11/2012,"12/11/2012",1/23/2013,"01/23/2013"
"Devices",64013,"Ongoing","Becton Dickinson & Company","Franklin Lakes","NJ","US","Voluntary: Firm Initiated","Letter","Nationwide Distribution","Z-0911-2013","Class III","BD Vacutainer PST Gel and Lithium Heparin (LH); 83 Units; Plus Blood Collection Tubes; Sterile; IVD; REF 367962; 4.5 mL, 13 X 100 mm; BD, Franklin Lakes, NJ USA; Made in USA. Used in hospitals, outpatient clinics and physicians' offices to collect blood from patients for specialized chemistry testing. ","Reference No.: 367960; Tube Size: 13 X 75. Reference Nos. 367961-367963, and 368035; Tube Size: 13 X 100; all lots",,"225 million units","BD is conducting a recall of the BD Vacutainer Plus Plastic Plasma Separator Tube (PST) with Light Green/BD Homogard Closure due to a deformed top of the tube reservoir reported in two customer complaints.",3/5/2012,"03/05/2012",3/13/2013,"03/13/2013"
"Drugs",64014,"Ongoing","Warner Chilcott Company LLC","Fajardo","PR","US","Voluntary: Firm Initiated","Letter","US Nationwide","D-142-2013","Class III","Femtrace 0.45 mg (Estradiol Acetate) Tablets, Rx Only, 100 tablets, Manufactured by Pharmaceutics International Inc, Hunt Valley, MD 21031 for Warner Chilcott Company LLC, Fajardo, PR 00738","0.45 mg: 505969A",".","3155 bottles","Failed Impurity/Degradation Specifications due to moisture ingress in individual bottles",12/21/2012,"12/21/2012",2/6/2013,"02/06/2013"
"Drugs",64014,"Ongoing","Warner Chilcott Company LLC","Fajardo","PR","US","Voluntary: Firm Initiated","Letter","US Nationwide","D-141-12013","Class III","Femtrace 0.9 mg (Estradiol Acetate) Tablets, Rx Only, 100 tablets, Manufactured by Pharmaceutics International Inc, Hunt Valley, MD 21031 for Warner Chilcott Company LLC, Fajardo, PR 00738","0.9 mg: 512348A ",".","5439 bottles","Failed Impurity/Degradation Specifications due to moisture ingress in individual bottles",12/21/2012,"12/21/2012",2/6/2013,"02/06/2013"
"Devices",64015,"Ongoing","Abbott Medical Optics Inc (AMO)","Santa Ana","CA","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution - USA Nationwide including the state of OH and the countries of: Germany, Switzerland, Sweden, Italy, China, France, Singapore, UK, Croatia, Hungary, Turkey and Brazil.","Z-0929-2013","Class II","AMO Sensar Intraocular Lenses (IOLs), Model AR40e, Sensar Foldable IOL with OptiEdge Product Usage: These are ultraviolet-absorbing posterior chamber intraocular lenses for use after cataract extraction. ","Diopter 18.04760271207 4760661207 4761191207 4760281207 4760681207 4761211207 4760291207 4760701207 4761221207 4760301207 4760721207 4761231207 4760311207 4760741207 4761241207 4760321207 4760761207 4761251207 4760331207 4760781207 4761261207 4760341207 4760801207 4761271207 4760351207 4760811207 4761281207 4760361207 4760821207 4760371207 4760841207 4760381207 4760861207 4760391207 4760881207 4760401207 4760901207 4760411207 4760921207 4760421207 4760941207 4760431207 4760961207 4760441207 4760981207 4760451207 4761001207 4760461207 4761031207 4760471207 4761041207 4760481207 4761051207 4760491207 4761061207 4760501207 4761071207 4760511207 4761081207 4760531207 4761091207 4760551207 4761101207 4760571207 4761111207 4760591207 4761121207 4760601207 4761131207 4760611207 4761151207 4760621207 4761161207 4760631207 4761171207 4760641207 4761181207 Diopter 23.5 4759221207 4759821207 4760161207 4759231207 4759831207 4760171207 4759241207 4759841207 4760181207 4759251207 4759851207 4760191207 4759261207 4759861207 4760201207 4759271207 4759871207 4760211207 4759281207 4759881207 4760221207 4759291207 4759891207 4760231207 4759311207 4759901207 4760241207 4759321207 4759911207 4760251207 4759331207 4759921207 4759341207 4759931207 4759361207 4759941207 4759381207 4759951207 4759401207 4759961207 4759421207 4759971207 4759441207 4759981207 4759461207 4759991207 4759481207 4760001207 4759671207 4760011207 4759681207 4760021207 4759691207 4760031207 4759701207 4760041207 4759711207 4760051207 4759721207 4760061207 4759731207 4760071207 4759741207 4760081207 4759751207 4760091207 4759761207 4760101207 4759771207 4760111207 4759781207 4760121207 4759791207 4760131207 4759801207 4760141207 4759811207 4760151207 ",,"155 units","Two production orders of these IOLs that contain mislabeled IOLs. ",12/20/2012,"12/20/2012",3/20/2013,"03/20/2013"
"Food",64016,"Ongoing","Southwest Ice Cream Specialties","Mckinney","TX","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Product was distributed in the following states: Arkansas, Arizona, Colorado, Kansas, Oklahoma, New Mexico and Texas.","F-1527-2013","Class I","''Shurfine CREAMERY SELECT PREMIUM ICE CREAM Dulce de Leche Caramel Swirled in Caramel Ice Cream KEEP FROZEN 1.75 QUARTS (1.66L)'' is displayed on the carton's label in error. The lid bears the label ''Shurfine CREAMERY SELECT PREMIUM ICE CREAM Praline Pecan KEEP FROZEN 1.75 QUARTS (1.661L)''. The product bears UPC 015400224840, a Best Buy date of NOV 8, 2014, and a Plant Code of 48-3202-F. ","UPC 015400224840, Best by NOV 8, 2014, and Plant Code 48-3202-F",".","1,524 cartons","Product may contain undeclared pecan, soy, and/or wheat allergens.",1/2/2013,"01/02/2013",6/19/2013,"06/19/2013"
"Devices",64017,"Ongoing","Quidel Corporation","San Diego","CA","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution - USA (nationwide) and internationally to Korea, Norway, Germany, Chile, Hong Kong, Switzerland, Netherlands, Thailand, Japan, China, and the UK","Z-0819-2013","Class II","Quidel, Sofia Influenza A + B FIA, Kit #20218 (25-Test Kit), in vitro diagnostic.","Lot # Range: 208228-214385, 707916-708108 (29 lots).",,"13,090 kits (327,250 tests)","Quidel Corporation has initiated a voluntary recall of specific lots of the Sofia Influenza A+B FIA kits because of false positive results which may lead to misdiagnosis. ",12/3/2012,"12/03/2012",2/20/2013,"02/20/2013"
"Drugs",64018,"Ongoing","Mobius Therapeutics LLC","Saint Louis","MO","US","Voluntary: Firm Initiated","Telephone","Nationwide and Military and Government Consignees","D-809-2013","Class I","Mitosol (mitomycin for solution), 0.2 mg/vial, Kit for Ophthalmic Use (NDC 49771-002-01), 3 kits per box (NDC 49771-002-03), Rx only, Manufactured for: Mobius Therapeutics, LLC, 4041 Forest Park Avenue, St. Louis, MO 63108 USA.","Lot #: M086920 and M098260, Exp. 08/2013",,"83 boxes","Non-Sterility: one or more components of the kit have been found to be contaminated with yeast.",1/3/2013,"01/03/2013",7/31/2013,"07/31/2013"
"Drugs",64020,"Ongoing","Hillyard GMP","Saint Joseph","MO","US","Voluntary: Firm Initiated","E-Mail","Distribution nationwide","D-140-2013","Class II","HILLYARD, Alcohol Free Foaming Instant Hand Sanitizer, Benzalkonium Chloride 0.10%, 1.25 L plastic bottle, OTC, HILLYARD IDUSTRIES, St. Joseph, MO. 64502 NDC 76402-403-03","Lot 1025554, Exp: 03/14 and Lot 1030652, Exp: 09/14",".","2,139 bottles","Microbial Contamination of Non-Sterile Products: The product may be contaminated with bacteria. ",12/28/2012,"12/28/2012",2/6/2013,"02/06/2013"
"Food",64021,"Ongoing","C H S Inc","Hutchinson","KS","US","Voluntary: Firm Initiated","E-Mail","Distribution was made to MI, KY, WI, OH,","F-0962-2013","Class II","Kitchen Essentials Imitation Bacon Flavored Bits, contains soy and wheat, packaged in 10 lb bulk cartons. Distributed by Gordon Food Service, Grand Rapids, MI. UPC 0 00 93901 6, Supplier item 293628","Lot 12257 and Lot 12258",".","2,474 containers","The product contains Soy and Wheat and is packaged in cartons in which the ingredient statement is missing.",1/3/2013,"01/03/2013",2/6/2013,"02/06/2013"
"Biologics",64022,"Terminated","Blood Assurance Inc","Chattanooga","TN","US","Voluntary: Firm Initiated","Telephone","Tennessee; Indiana","B-0852-13","Class III","Blood and Blood Products for Reprocessing","W043211091557; ",".","1","Blood products, collected from a donor whose suitability to donate was not adequately determined, were distributed.",11/29/2012,"11/29/2012",4/10/2013,"04/10/2013"
"Biologics",64022,"Terminated","Blood Assurance Inc","Chattanooga","TN","US","Voluntary: Firm Initiated","Telephone","Tennessee; Indiana","B-0851-13","Class II","Red Blood Cells Leukocytes Reduced","W043211091557; ",".","1","Blood products, collected from a donor whose suitability to donate was not adequately determined, were distributed.",11/29/2012,"11/29/2012",4/10/2013,"04/10/2013"
"Biologics",64023,"Terminated","Hoxworth Blood Center UC Medical Center","Cincinnati","OH","US","Voluntary: Firm Initiated","Letter","OH","B-0939-13","Class II","Red Blood Cells (Apheresis) Leukocytes Reduced","W037712008772; W037712008772; W037711175343; W037711175343; W037711138674; W037711138674; ",".","6 units","Blood products, collected from a donor who traveled to a malarial endemic area, were distributed.",7/23/2012,"07/23/2012",4/24/2013,"04/24/2013"
"Biologics",64024,"Terminated","Blood Bank of Alaska, Inc.","Anchorage","AK","US","Voluntary: Firm Initiated","FAX","Alaska","B-0874-13","Class II","Red Blood Cells Leukocytes Reduced Irradiated Washed","W066512427602",".","1 unit","Blood product, collected from a donor who received a tattoo, was distributed.",12/20/2012,"12/20/2012",5/29/2013,"05/29/2013"
"Biologics",64025,"Terminated","Blood Assurance Inc","Chattanooga","TN","US","Voluntary: Firm Initiated","Telephone","TN and IN","B-0983-13","Class II","Blood and Blood Products for Reprocessing","W043211091555",".","1 unit","Blood products, collected from a donor in which donor suitability was not adequately determined, were distributed.",11/29/2012,"11/29/2012",5/1/2013,"05/01/2013"
"Biologics",64025,"Terminated","Blood Assurance Inc","Chattanooga","TN","US","Voluntary: Firm Initiated","Telephone","TN and IN","B-0982-13","Class II","Red Blood Cells Leukocytes Reduced","W043211091555",".","1 unit","Blood products, collected from a donor in which donor suitability was not adequately determined, were distributed.",11/29/2012,"11/29/2012",5/1/2013,"05/01/2013"
"Biologics",64026,"Terminated","South Texas Blood & Tissue Center","San Antonio","TX","US","Voluntary: Firm Initiated","FAX","FL; TX","B-0980-13","Class II","Red Blood Cells Leukocytes Reduced","W140912204923",".","1 unit","Blood products, collected from a donor who may be at risk for variant Creutzfeldt-Jakob Disease (vCJD), were distributed.",11/21/2012,"11/21/2012",7/10/2013,"07/10/2013"
"Biologics",64026,"Terminated","South Texas Blood & Tissue Center","San Antonio","TX","US","Voluntary: Firm Initiated","FAX","FL; TX","B-0981-13","Class II","Blood and Blood Products for Reprocessing","W140912204923",".","1 unit","Blood products, collected from a donor who may be at risk for variant Creutzfeldt-Jakob Disease (vCJD), were distributed.",11/21/2012,"11/21/2012",7/10/2013,"07/10/2013"
"Biologics",64027,"Terminated","BloodCenter of Wisconsin, Inc","Milwaukee","WI","US","Voluntary: Firm Initiated","FAX","WI","B-0869-13","Class II","Fresh Frozen Plasma (Apheresis)","W036312246748",".","1 unit","Blood product, collected from a donor whose suitability to donate was not adequately determined, was distributed.",11/20/2012,"11/20/2012",4/24/2013,"04/24/2013"
"Devices",64028,"Ongoing","Exactech, Inc.","Gainesville","FL","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Distributed in the states of TN, FL, VA, WA and NV.","Z-0787-2013","Class II","Exactech NOVATION CROWN CUP, NEUTRAL LINER, Use with Crown Cup Only, GXL UHMWPE, SN 0123456, REF 130-32-53. Exactech Hip Systems are indicated for use in surgery for hip replacement.","Catalog No. 130-3253, Serial Numbers 2479944 - 2479969 and Catalog No. 136-32-53, Serial Numbers 2479873 - 2479898.",,"26 Units","Recall of Novation Crown Cup Connection GXL Neutral Liners Catalog No. (130-32-53) and Novation Crown Cup Connection GXL + 5mm Lateralized Liners Catalog No. (136-32-53). Exactech discovered the device labeling was inadvertently transposed.",11/5/2012,"11/05/2012",2/13/2013,"02/13/2013"
"Devices",64028,"Ongoing","Exactech, Inc.","Gainesville","FL","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Distributed in the states of TN, FL, VA, WA and NV.","Z-0788-2013","Class II","Exactech NOVATION CROWN CUP +5mm LATERALIZED LINER, Use with Crown Cup Only, GXL UHMWPE, SN 0123456, REF 136-32-53. Exactech Hip Systems are indicated for use in surgery for hip replacement.","Catalog No. 130-3253, Serial Numbers 2479944 - 2479969 and Catalog No. 136-32-53, Serial Numbers 2479873 - 2479898.",,"26 Units","Recall of Novation Crown Cup Connection GXL Neutral Liners Catalog No. (130-32-53) and Novation Crown Cup Connection GXL + 5mm Lateralized Liners Catalog No. (136-32-53). Exactech discovered the device labeling was inadvertently transposed.",11/5/2012,"11/05/2012",2/13/2013,"02/13/2013"
"Devices",64029,"Ongoing","Lockheed Martin Gyrocam Systems, Inc.","Sarasota","FL","US","Voluntary: Firm Initiated","Letter","Nationwide Distribution","Z-0654-2013","Class II","Lockheed Martin Gyrocam Systems ( LMGS) LMGS 15'' camera systems Laser pointer and illuminator used for law enforcement surveillance from aircraft. Models DNV, TS and DS","''Gyrocam DNV Camera System, Serial Numbers: 137, 138, 141, 142, 143, 144, 145, 148, 150, 151,152, 158, 159, 160, 164, 165, 170, 172, 173, 174, 175, 177; Gyrocam DS Camera System, Serial Numbers: 134, 140, 147, 153, 169, 181; Gyrocam TS Camera System, Serial Numbers: 132, 146, 149, 171, 502. ''",,"33 units","These camera systems were manufactured by LMGS and found to fail to comply with the FDA laser performance standard during an FDA inspection. These camera systems incorporate Class IIIb surveying, leveling, and alignment lasers and were entered into US commerce without a variance. Additionally, the manufacturer did not submit a product report to FDA for the camera system.",1/21/2010,"01/21/2010",2/20/2013,"02/20/2013"
"Food",64030,"Ongoing","Somersault Snack Co., LLC","Sausalito","CA","US","Voluntary: Firm Initiated","Press Release","Nationwide and Canada","F-0879-2013","Class I","Somersault brand Cinnamon Crunch. Crunchy nuggets baked with sunflower seeds and toasted grains. Sunflower seed snack. .5 oz, 1 oz., 2 oz., 6 oz., and 16 oz.","Cinnamon Crunch 12ct; 6oz. Case Code10-8-98403-002-27-4;Product Code 8-98403-002-27-7; Sell By: 8/30/2013 or earlier Cinnamon Crunch 16ct; 2oz.Case Code10-8-98403-002-27-4; Product Code8-98403-002-27-7; Sell By: 8/30/2013 or earlier Cinnamon Crunch 100ct; 0.5oz., Case Code10-8-98403-002-24-3; Product Code 8-98403-002-24-6; Sell By: 8/30/2013 or earlier Cinnamon Crunch 36ct; 1oz.Case Code10-8-98403-002-23-6; Product Code 8-98403-002-22-2; Sell By: 8/30/2013 or earlier, Cinnamon Crunch 50ct; 1oz., Case Code 10-8-98403-002-22-9; Product Code 8-98403-002-22-2; Sell By: 8/30/2013 or earlier Cinnamon Crunch Bulk 8ct; 16oz. (for samples only, no case and product code)Sell By: 8/30/2013 or earlier Shipper 36ct; 1oz. SS CC, Case Code10-8-98403-002-26-7; Product Code 8-98403-002-22-2; Sell By: 8/30/2013 or earlier",".","36,757 cases","During ingredient review for kosher certification, the firm discovered that the finished product package did not bear a milk allergen declaration, although a flavor ingredient was found to contain milk",1/7/2013,"01/07/2013",1/23/2013,"01/23/2013"
"Biologics",64031,"Terminated","LifeShare Blood Centers","Alexandria","LA","US","Voluntary: Firm Initiated","FAX","Michigan, Louisiana","B-0959-13","Class II","Recovered Plasma","W036512102516",".","1 unit","Blood products, collected from a donor who received a tattoo within one year of donation, were distributed.",12/3/2012,"12/03/2012",4/10/2013,"04/10/2013"
"Biologics",64031,"Terminated","LifeShare Blood Centers","Alexandria","LA","US","Voluntary: Firm Initiated","FAX","Michigan, Louisiana","B-0958-13","Class II","Fresh Frozen Plasma","W036512102516",".","1 unit","Blood products, collected from a donor who received a tattoo within one year of donation, were distributed.",12/3/2012,"12/03/2012",4/10/2013,"04/10/2013"
"Biologics",64032,"Terminated","Inland Northwest Blood Center","Spokane","WA","US","Voluntary: Firm Initiated","FAX","Washington","B-0956-13","Class II","Platelets Pheresis Leukocytes Reduced Irradiated","W068512009222W (3 units) ",".","3 units","Blood products, collected from a donor who had taken aspirin, were distributed.",11/16/2012,"11/16/2012",4/10/2013,"04/10/2013"
"Biologics",64033,"Terminated","Blood Systems, Inc. dba United Blood Services","Lubbock","TX","US","Voluntary: Firm Initiated","Telephone","Texas","B-0957-13","Class II","Red Blood Cells (Apheresis) Leukocytes Reduced","W041512046908J (2 units) ",".","2 units","Blood products, which were incorrectly labeled as negative anti-K, were distributed.",11/13/2012,"11/13/2012",4/10/2013,"04/10/2013"
"Biologics",64034,"Terminated","Community Blood Centers of Florida, Inc.","Lauderhill","FL","US","Voluntary: Firm Initiated","Letter","Florida","B-0962-13","Class II","Red Blood Cells","W036810177987",".","1 unit","Blood product, collected from a donor for whom donor suitability was not adequately determined, was distributed.",12/17/2012,"12/17/2012",4/10/2013,"04/10/2013"
"Biologics",64035,"Terminated","Community Blood Centers of South Florida, Inc.","Hialeah","FL","US","Voluntary: Firm Initiated","Letter","Switzerland, Florida","B-0961-13","Class II","Red Blood Cells","W036811070000",".","1 unit","Blood products, collected from a donor for whom donor suitability was not adequately determined, were distributed.",11/27/2012,"11/27/2012",4/10/2013,"04/10/2013"
"Biologics",64035,"Terminated","Community Blood Centers of South Florida, Inc.","Hialeah","FL","US","Voluntary: Firm Initiated","Letter","Switzerland, Florida","B-0960-13","Class III","Recovered Plasma","W036811070000",".","1 unit","Blood products, collected from a donor for whom donor suitability was not adequately determined, were distributed.",11/27/2012,"11/27/2012",4/10/2013,"04/10/2013"
"Biologics",64036,"Terminated","Community Blood Centers of South Florida, Inc.","Hialeah","FL","US","Voluntary: Firm Initiated","Letter","Florida","B-0887-13","Class II","Red Blood Cells","W036812530523; ",,,"Blood products, which were collected from a donor in which donor suitability was not adequately determined, were distributed.",12/14/2012,"12/14/2012",4/17/2013,"04/17/2013"
"Biologics",64036,"Terminated","Community Blood Centers of South Florida, Inc.","Hialeah","FL","US","Voluntary: Firm Initiated","Letter","Florida","B-0940-13","Class III","Blood and Blood Products for Reprocessing","W036812530523; ",,"1","Blood products, which were collected from a donor in which donor suitability was not adequately determined, were distributed.",12/14/2012,"12/14/2012",4/17/2013,"04/17/2013"
"Biologics",64037,"Terminated","Community Blood Centers of Florida, Inc.","Lauderhill","FL","US","Voluntary: Firm Initiated","Letter","Florida; New York; Texas","B-0946-13","Class II","Platelets Pooled Leukocytes Reduced","W036811822641; ",,"1 unit","Blood products, which were collected from a donor in which donor suitability was not adequately determined, were distributed.",12/17/2012,"12/17/2012",4/17/2013,"04/17/2013"
"Biologics",64037,"Terminated","Community Blood Centers of Florida, Inc.","Lauderhill","FL","US","Voluntary: Firm Initiated","Letter","Florida; New York; Texas","B-0947-13","Class II","Fresh Frozen Plasma","W036811261912; ",,"1 unit","Blood products, which were collected from a donor in which donor suitability was not adequately determined, were distributed.",12/17/2012,"12/17/2012",4/17/2013,"04/17/2013"
"Biologics",64037,"Terminated","Community Blood Centers of Florida, Inc.","Lauderhill","FL","US","Voluntary: Firm Initiated","Letter","Florida; New York; Texas","B-0948-13","Class II","Red Blood Cells Leukocytes Reduced","W036811261912; ",,"1 unit","Blood products, which were collected from a donor in which donor suitability was not adequately determined, were distributed.",12/17/2012,"12/17/2012",4/17/2013,"04/17/2013"
"Biologics",64038,"Terminated","Kapiolani Medical Center for Women and Children","Honolulu","HI","US","Voluntary: Firm Initiated","Telephone","Hawaii","B-0694-13","Class III","Red Blood Cells Leukocytes Reduced","W0888412535911; ",".","1 unit","Blood product, which label was applied to blood unit with incorrect or missing information, was distributed.",8/24/2012,"08/24/2012",4/24/2013,"04/24/2013"
"Devices",64039,"Ongoing","Quanta System, S.p.A.","Solbiate Olona (VA)",,"IT","Voluntary: Firm Initiated","Letter","Class II Recall - Worldwide Distribution - USA including TX, AZ, OR, and CO. Only US product is affected by this recall.","Z-0691-2013","Class II","Q-Plus T Powered Laser Surgical Instrument Nd:YAG 1064 nm and 532 nm: Treatment of vascular lesions and pigmented lesions; Hair and tattoo removal; The incision, excision, ablation, vaporization of soft tissue for general dermatology. Ruby 694nm: Cutting, vaporization and ablation of soft tissue; Tattoo removal; Treatment of benign pigmented lesions.","All codes and devices are applicable.",".","75 units","Quanta System S.p.A, Italy, is notifying U.S. consignees that their website contained promotional materials for products distributed in the U.S. which did not specify that some of the claims made therein were not meant to apply to the U.S. distributed devices.",11/7/2012,"11/07/2012",1/23/2013,"01/23/2013"
"Devices",64039,"Ongoing","Quanta System, S.p.A.","Solbiate Olona (VA)",,"IT","Voluntary: Firm Initiated","Letter","Class II Recall - Worldwide Distribution - USA including TX, AZ, OR, and CO. Only US product is affected by this recall.","Z-0692-2013","Class II","Eterna Giovinezza System, Powered Laser Surgical Instrument. Permanent hair reduction; Photocoagulation of dermatological vascular lesions; Photothermolysis of blood vessels (treatment of facial and leg veins); Treatment of benign pigmented lesions; Inflammatory acne","All codes and devices are applicable.",".","12 units","Quanta System S.p.A, Italy, is notifying U.S. consignees that their website contained promotional materials for products distributed in the U.S. which did not specify that some of the claims made therein were not meant to apply to the U.S. distributed devices.",11/7/2012,"11/07/2012",1/23/2013,"01/23/2013"
"Devices",64039,"Ongoing","Quanta System, S.p.A.","Solbiate Olona (VA)",,"IT","Voluntary: Firm Initiated","Letter","Class II Recall - Worldwide Distribution - USA including TX, AZ, OR, and CO. Only US product is affected by this recall.","Z-0693-2013","Class II","Ultrawave II EX 1320/ Ultrawave III EX 1320 Powered Laser Surgical Instrument. Nd:YAG 1064 nm: Coagulation and hemostasis of benign vascular lesions (e.g. port wine stains, hemangiomas, warts, telangiectasia, rosacea, venus lake, leg and spider veins, scars, straie and psoriasis; Treatment of benign pigmented lesions to reduce lesion size, for patients with lesions that would potentially benefit from aggressive treatment, and for patients with lesions that have not responded to other laser treatments; Treatment of facial wrinkles (e.g. periocular and periorbital); Removal of unwanted hair, for the stable longterm, or permanent, hair reduction, including Fitzpatrick IVI and suntanned skin types; For the treatment of pseudofolliculitis barbae (PFB); Reduction of red pigmentation in hypertrophic and keloid scars where vascularity is an integral part of the scar; For use on all skin types (Fitzpatrick IVI) including tanned skin. Alexandrite 755 nm: Coagulation and hemostasis of vascular lesions and the removal and permanent reduction of unwanted hair in Fitzpatrick skin types 1VI, including suntanned skin types; Pigmented lesions; Wrinkles. Nd: YAG 1320 nm: General surgery and dermatology for the incision, excision, ablation, vaporization, coagulation and hemostasis of soft tissue; Treatment of periorbital and periocular wrinkles, fine lines and wrinkles, treatment of back acne and atrophic acne scars. IPL: Permanent hair reduction; Photocoagulation of dermatological vascular lesion (i.e. face telangiectasia); Photothermolysis of blood vessels (treatment of facial and leg veins); Treatment of benign pigmented lesions.","All codes and devices are applicable.",".","22 units","Quanta System S.p.A, Italy, is notifying U.S. consignees that their website contained promotional materials for products distributed in the U.S. which did not specify that some of the claims made therein were not meant to apply to the U.S. distributed devices.",11/7/2012,"11/07/2012",1/23/2013,"01/23/2013"
"Food",64040,"Ongoing","Coca-Cola Company (The)","Atlanta","GA","US","Voluntary: Firm Initiated","Visit","FL","F-0917-2013","Class III","Coca-Cola, 12 fluid ounce aluminum cans in 20-packs and 32-packs, The Coca Cola Company.","UPC: 496340, Optimum Taste Code: SEP1613HWA",".","31,000 cases (32 cans/case and 20 cans/case)","Complaints received of off taste/odor.",1/2/2013,"01/02/2013",1/30/2013,"01/30/2013"
"Drugs",64041,"Ongoing","AstraZeneca LP","Westborough","MA","US","Voluntary: Firm Initiated","Letter","Nationwide","D-198-2013","Class III","PULMICORT RESPULES 0.25 mg/2 ml Budesonide Inhalation Suspension (30 ampules/carton) NDC: 0186-1988-04","Lot/Exp date:AH0054 Exp 5/14; AK0125 Exp 7/14",,"28,476 cartons","Does Not Meet Monograph: Budesonide may be slightly above or below the specification range.",1/11/2013,"01/11/2013",3/20/2013,"03/20/2013"
"Drugs",64041,"Ongoing","AstraZeneca LP","Westborough","MA","US","Voluntary: Firm Initiated","Letter","Nationwide","D-199-2013","Class III","PULMICORT RESPULES 0.5 mg/2 ml (30 ampules/carton)Budesonide Inhalation Suspension NDC: 0186-1989-04","Lot/Exp Date:YP0035 11/13; YP0140 12/13; YP0136 12/13; AB0077 2/14; AH0133 5/14",,"64675 cartons","Does Not Meet Monograph: Budesonide may be slightly above or below the specification range.",1/11/2013,"01/11/2013",3/20/2013,"03/20/2013"
"Food",64042,"Ongoing","Conagra Inc","Omaha","NE","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Distribution was made to NJ, NY, PA, CT, WV, MD, DE and VA.","F-0918-2013","Class II","Andy Capp's Cheddar Cheese Fries packaged in Andy Capp's Hot Fries, 0.85-oz foil bags, snack size, Case UPC: 20-0-26200-47169-7 and Unit UPC: 00-0-26200-47168-6.","Best By: AUG 17 13 and (batch number) 5381232500",".","756/72/.85-oz bag cases","Andy Capp's Cheddar Cheese Fries snacks were packaged in Andy Capp's Hot Fries snack bags in error. The Cheddar Cheese Fries contain Soy which is not listed on the ingredients label of the Hot Fries bag.",1/4/2013,"01/04/2013",1/30/2013,"01/30/2013"
"Devices",64043,"Ongoing","Abbott Point of Care Canada Limited","Nepean",,"CA","Voluntary: Firm Initiated","Telephone","Worldwide Distribution.","Z-0716-2013","Class II","Abbott Point of Care i-Stat cTnI cartridge. The i-Stat cardiac troponin I (cTnI) test is an in vitro diagnostic test for the quantitive measurement of cardiac troponin I (cTnI) in whole blood or plasma. Measurements of cardiac troponin I are used in the diagnosis and treatment of myocardial infarction and as an aid in the risk stratification of patients with acute coronary syndromes with respect to the relative risk of mortality. ","List number 06F15-03, O6F15-04, 03P90-25, 600-9009-25 Lot number P12179",".","560 boxes (25 cartridges in each box)","APOC has determined that 10 boxes of i-Stat cTnI cartridges from lot P12179 have an incorrect barcode applied to the cartridge portion pack.",11/1/2012,"11/01/2012",1/30/2013,"01/30/2013"
"Devices",64044,"Ongoing","Invacare Corporation","Elyria","OH","US","Voluntary: Firm Initiated","Letter","US Nationwide Distribution including the states of CA & MT.","Z-0785-2013","Class II","Solara 3G Custom Manual Wheelchair Product Usage: To provide mobility to a person restricted to a sitting position.","Model #3G, Serial numbers: 12GE003750, 12GE003554 and 12HE001766.",,"3 units","The potential exists for the wheel to rotate freely despite engagement of hub brake.",9/10/2012,"09/10/2012",2/13/2013,"02/13/2013"
"Food",64046,"Ongoing","Woodstock Farms","Edison","NJ","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Alabama, Connecticut, Florida, Georgia, Illinois, Maine, Maryland, Massachusetts, Michigan, Minnesota, Missouri, New Hampshire, New Jersey, New York, North Carolina, Ohio, Oklahoma, Pennsylvania, Rhode Island, South Carolina, South Dakota, Tennessee, Vermont, Virginia, Wisconsin, and District of Columbia","F-0886-2013","Class I","Woodstock All Natural Tamari Almonds, 7.5 OZ in a gusseted re-sealable poly bag.","Best By: 10/24/13 Lot: 12298 UPC# 0-42563-00838-3",".","67 cases, each containing 8 packages per shipping case","Undeclared soy ingredient on mislabeled back panel. While the Tamari Almonds contain soy, the ingredient statement does not include soy. In addition, the nutrition facts and UPC# are incorrect which corresponds to another almond product. People who have an allergy or severe sensitivity to soy run the risk of serious or life-threatening allergic reaction if they consume this product.",1/8/2013,"01/08/2013",1/23/2013,"01/23/2013"
"Food",64047,"Ongoing","Family Food Distributor, Inc.","Kearny","NJ","US","Voluntary: Firm Initiated","Letter","NY, NJ, OH","F-0977-2013","Class III","Mama Tere Cebada Natural Barley Flour Net Weight /Peso Neto: 12 oz (340g) Family Food Distributors Bergen Avenue Kearny, NY 07032 UPC 7412003000259","n/a",,,"Mama Tere Cebada Flour contains undeclared colors Red #3 and Red #40.",11/20/2012,"11/20/2012",2/13/2013,"02/13/2013"
"Food",64048,"Ongoing","Miami Growers Inc.","Jersey City","NJ","US","Voluntary: Firm Initiated","Telephone","NY, NJ, and PA","F-1326-2013","Class II","Siya Green Mukwhas Net Wt. 200 gm (7 oz) Distributed by: Miami Growers, Inc. 80 Broadway, Jersey City, NJ 07306 Phone: 201-985-9322, Fax: 201-985-9569 Email: miamigrowers@yahoo.com Visit us: www.miamigrowersinc.com A Product of India","All lots",".","1000 units (Approximately)","Siya Brand Green Mukwhas contain unapproved and undeclared colors.",12/4/2012,"12/04/2012",4/24/2013,"04/24/2013"
"Biologics",64049,"Terminated","Mid-South Regional Blood Center","Memphis","TN","US","Voluntary: Firm Initiated","FAX","Tennessee","B-0949-13","Class II","Red Blood Cells Leukocytes Reduced","W227712080362; ",,"1 unit","Blood products, which were collected from a donor who traveled to malarial endemic area, were distributed.",12/27/2012,"12/27/2012",4/17/2013,"04/17/2013"
"Biologics",64050,"Terminated","Community Blood Centers of Florida, Inc.","Lauderhill","FL","US","Voluntary: Firm Initiated","Letter","Michigan; Florida","B-1000-13","Class II","Fresh Frozen Plasma","2192852; ",".","1 unit","Blood products, which were collected from a donor in which donor suitability was not adequately determined, were distributed.",12/6/2012,"12/06/2012",4/24/2013,"04/24/2013"
"Biologics",64050,"Terminated","Community Blood Centers of Florida, Inc.","Lauderhill","FL","US","Voluntary: Firm Initiated","Letter","Michigan; Florida","B-1001-13","Class II","Platelets Irradiated","2192852; ",".","1 unit","Blood products, which were collected from a donor in which donor suitability was not adequately determined, were distributed.",12/6/2012,"12/06/2012",4/24/2013,"04/24/2013"
"Biologics",64050,"Terminated","Community Blood Centers of Florida, Inc.","Lauderhill","FL","US","Voluntary: Firm Initiated","Letter","Michigan; Florida","B-1002-13","Class II","Red Blood Cells (Apheresis) Leukocytes Reduced","2192852; ",".","1 unit","Blood products, which were collected from a donor in which donor suitability was not adequately determined, were distributed.",12/6/2012,"12/06/2012",4/24/2013,"04/24/2013"
"Biologics",64051,"Terminated","American National Red Cross, Penn-Jersey Region","Philadelphia","PA","US","Voluntary: Firm Initiated","FAX","Pennsylvania","B-1007-13","Class II","Plasma Frozen within 24 hours (FP24)","22GM75439; ",".","1","Blood product, collected from a donor considered to be at increased risk for variant Creutzfeldt-Jakob Disease (vCJD), was distributed.",11/21/2012,"11/21/2012",5/15/2013,"05/15/2013"
"Biologics",64052,"Terminated","South Bend Medical Foundation, Inc.","South Bend","IN","US","Voluntary: Firm Initiated","Letter","Indiana","B-1043-13","Class II","Red Blood Cells Leukocytes Reduced","W045212014473; ",".","1","Blood product, collected from a donor who reported travel to a malarial endemic area, was distributed.",12/21/2012,"12/21/2012",5/15/2013,"05/15/2013"
"Biologics",64053,"Terminated","Puget Sound Blood Center and Program","Seattle","WA","US","Voluntary: Firm Initiated","E-Mail","Austria","B-1006-13","Class II","Blood and Blood Products for Reprocessing","M169858; ",".","1","Blood product, collected from a donor considered to be at increased risk for variant Creutzfeldt-Jakob Disease (vCJD), was distributed.",10/2/2012,"10/02/2012",5/15/2013,"05/15/2013"
"Devices",64054,"Ongoing","bioMerieux, Inc.","Durham","NC","US","Voluntary: Firm Initiated","E-Mail","Worldwide Distribution.USA including the states of AR, AZ, CA, CO, DE, FL, GA, IL, IN, KY, LA, MD, MI, MN, MO, NC, NJ, NY, OH, OR, PA, RI, SC, SD, TN, TX, VA, WI, and WV, and the countries of China, Curacao and Japan.","Z-0738-2013","Class II","BacT/ALERT SA Blood Culture Bottle. The BacT/ALERT SA reagent bottle is intended to be recover and detect aerobic microorganisms (bacteria and fungi) from blood and other normally sterile body fluids.","Catalog Number: 259789, Lots/Batch: 1031866",".","1690 cases","BacT/ALERT SA Culture Bottle lot 1031866 may contain bottles with uncured sensors.",12/25/2012,"12/25/2012",2/6/2013,"02/06/2013"
"Devices",64055,"Ongoing","Ethicon Endo-Surgery Inc","Cincinnati","OH","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution - USA including the states of AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, NC, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, VA, WA, WI, & WV. and the countries Arab Emirates, Australia, Belgium, Canada, Chile, China, Colombia, Cyprus, Hong Kong, Indonesia, Israel, India, South Korea, Kuwait, Malaysia, Panama, Philippines, Puerto Rico, Russia, Saudi Arabia, Singapore, Slovenia, Thailand, Turkey & Vietnam.","Z-0758-2013","Class II","Ethicon Endo-Surgery Inc. The ENSEAL G2 Tissue Sealers are indicated for bipolar coagulation and mechanical transection of tissue during laparoscopic and open procedures. Model Numbers: NSLG2C14 NSLG2C25 NSLG2C35 NSLG2C45 NSLG2514 NSLG2S25 NSLG2S35 NSLGS545 ","Product Code NSLG2C14, Lot # H44Y2P, Exp. Date 11-2013, Lot # J4AR58, Exp. Date 4-2017, Lot # J4AT3V, Exp. Date 4-2017, Lot # J4AW5A, Exp. Date 5-2017, Lot # J4AX7D, Exp. Date 5-2017, Lot # J4C34A, Exp. Date 6-2017, Lot # J4C448, Exp. Date 7-2017, Lot # J4C449, Exp. Date 7-2017, Lot # J4C85G, Exp. Date 7-2017, Lot # J4CF5Z, Exp. Date 9-2017 and Lot # J4CG31, Exp. Date 9-2017. Product Code NSLG2C25, Lot # H44Z6V, Exp. Date 11-2013, Lot # J4A16C, Exp. Date 12-2013, Lot # J4AT1P, Exp. Date 4-2017, Lot # J4AR5L, Exp. Date 4-2017, Lot # J4AU2K, Exp. Date 5-2017, Lot # J4AV17, Exp. Date 5-2017, Lot # J4AW75, Exp. Date 5-2017, Lot # J4AW76, Exp. Date 5-2017, Lot # J4AY0T, Exp. Date 5-2017, Lot # J4C09P, Exp. Date 6-2017, Lot # J4C30A, Exp. Date 6-2017, Lot # J4C34L, Exp. Date 6-2017, Lot # J4C44N, Exp. Date 7-2017, Lot # J4C928, Exp. Date 7-2017, Lot # J4C92C, Exp. Date 7-2017, Lot # J4C968, Exp. Date 8-2017, Lot # J4CA4P, Exp. Date 8-2017, Lot # J4CF0D, Exp. Date 8-2017, Lot # J4CH3W, Exp. Date 9-2017, Lot # J4CJ5Y, Exp. Date 9-2017, Lot # J4CJ99, Exp. Date 9-2017 and Lot # J4CK1H, Exp. Date 9-2017. Product Code NSLG2C35, Lot # H44V7N, Exp. Date 10-2013, Lot # H44V7M, Exp. Date 10-2013, Lot # H44V7P, Exp. Date 10-2013, Lot # H44X9M, Exp. Date 11-2013, Lot # H44X9L, Exp. Date 11-2013, Lot # H44X9R, Exp. Date 11-2013, Lot # H44Z3R, Exp. Date 11-2013, Lot # H44Z4C, Exp. Date 11-2013, Lot # H44Z54, Exp. Date 11-2013, Lot # J4A085, Exp. Date 12-2013, Lot # J4A134, Exp. Date 12-2013, Lot # J4AN7K, Exp. Date 4-2017, Lot # J4AN8E, Exp. Date 4-2017, Lot # J4AN8D, Exp. Date 4-2017, Lot # J4AP7W, Exp. Date 4-2017, Lot # J4AR5P, Exp. Date 4-2017, Lot # J4AT05, Exp. Date 4-2017, Lot # J4AT9G, Exp. Date 4-2017, Lot # J4AT9V, Exp. Date 4-2017, Lot # J4AU2Z, Exp. Date 5-2017, Lot # J4AV2R, Exp. Date 5-2017, Lot # J4AV2V, Exp. Date 5-2017, Lot # J4AV4P, Exp. Date 5-2017, Lot # J4AV4Z, Exp. Date 5-2017, Lot # J4AW3F, Exp. Date 5-2017, Lot # J4AW3N, Exp. Date 5-2017, Lot # J4AW8P, Exp. Date 5-2017, Lot # J4AW8Y, Exp. Date 5-2017,",".","58,338 Instruments","Ethicon Endo-Surgery initiated a voluntary global recall for all production lots of ENSEAL G2 Curved and Straight Tissue Sealers due to a potential for self activation while the device is in use, which may result in unintended thermal damage.",11/6/2012,"11/06/2012",2/6/2013,"02/06/2013"
"Drugs",64056,"Ongoing","Watson Pharmaceuticals","Parsippany","NJ","US","Voluntary: Firm Initiated","E-Mail","Nationwide and Puerto Rico","D-145-2013","Class II","Taztia XT(diltiazem HCI extended release capsules, USP, Once-A-Day Dosage, 360 mg, 90 Capsules per bottle, Rx only, Manufactured by: Watson Laboratories, Inc., Corona, CA 92880, Distributed by: Watson Pharma, NDC 62037-700-90.","Lot #: 512146A, Exp 01/31/2014",,"3,040 bottles ","Failed Dissolution Specification: Out of a specification result occurred during the 3-month stability testing. Dissolution result at the 4-hour time point was 41% (specification: 20-40%). ",12/18/2012,"12/18/2012",2/13/2013,"02/13/2013"
"Devices",64057,"Ongoing","Oxus America, Inc.","Rochester Hills","MI","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution-USA including the states of New York, Michigan, Colorado, Texas, Iowa, Florida, Georgia, Ohio, Wisconsin, Oregon, Alabama, Illinois, Utah, Oklahoma, West Virginia and California and the countries of Canada, European Union, South Africa, Korea and Brazil.","Z-0768-2013","Class II","Li-Ion battery used in the Oxus Portable Oxygen Concentrator (POC), RS-00400. Also branded as Reliability Plus byDrive. The Portable Oxygen Concentrator is intended to deliver concentrated oxygen for adult patients with chronic pulmonary diseases.","part number RS-00402 Unit ID # (TS-): 001418, 001419, 001420, 001421, 001422, 001423, 001424, 001425, 001426, 001427, 001428, 001429, 001430, 001431, 001432, 001433, 001434, 001435, 001436, 001437, 001438, 001439, 001440, 001441, 001442, 001443, 001444, 001445, 001446, 001447, 001448, 001449, 001450, 001451, 001452, 001453, 001454, 001455, 001456, 001457, 001458, 001459, 001460, 001461, 001462, 001463, 001464, 001465, 001466, 001467, 001468, 001469, 001470, 001471, 001472, 001473, 001474, 001475, 001476, 001477, 001478, 001479, 001480, 001481, 001482, 001483, 001484, 001485, 001486, 001487, 001488, 001489, 001490, 001491, 001492, 001493, 001494, 001495, 001496, 001497, 001498, 001499, 001551, 001552, 001557, 001558, 001559, 001560, 001561, and 001562. Battery SN (MB-): 06625x, 06666x, 06679x, 06715x, 08335x, 06498x, 01578x, 12009x, 12010x, 00075x, 05624x, 11868x, 11855x, 11587x, 11601x, 08240x, 08336x, 06145x, 06160x, 06302x, 06305x, 08189x, 08190x, 09200x, 09562x, 09564x, 09654x, 09719x, 09720x, 09787x, 09788x, 09887x, 09902x, 09903x, 09904x, 09905x, 09906x, 09957x, 09958x, 09959x, 09960x, 09961x, 10049x, 10477x, 10478x, 10479x, 10480x, 05689x, 05690x, 05694x, 05695x, 05696x, 05727x, 07937x, 07938x, 07940x, 07941x, 08072x, 08112x, 08125x, 10358x, 11165x, 11166x, 11961x, 11027x, 08628x, 08630x, 09143x, 09144x, 09145x, 09146x, 09498x, 09888x, 09889x, 09890x, 09891x, 09983x, 09984x, 10547x, 10549x, 10550x, 01476x, 01527x, 01576x, 05630x, 08657x, 08677x, 08752x, 08753x, 08755x, 08838x, 09724x, 10237x, 10582x, 10597x, 10600x, 11252x, 11253x, 11264x, 11265x, 11266x, 11271x, 11272x, 11469x, 11472x, 11473x, 11525x, 11526x, 11527x, 11528x, 11999x, 01518x, 09212x, 10584x, 10602x, 11110x, 11426x, 11427x, 11456x, 11471x, 11478x, 11485x, 11486x, 11514x, 11518x, 11589x, 11591x, 11592x, 11593x, 05647x, 05648x, 05649x, 06646x, 06672x, 06673x, 06674x, 06675x, 06676x, 06702x, 07558x, 07637x, 07638x, 07639x, 07640x, 07641x, 07643x, 07644x, 07645x, 07663x, 07680x, 07689x, 07691x, 07697x, 07703x, 07704x, 07705x, 08257x, 08258",,"1724 total units","Due to past battery inventory storage conditions and deficiencies in the maintenance procedure, it was possible that some batteries were over-discharged to point of damaging the cells.",1/14/2013,"01/14/2013",2/13/2013,"02/13/2013"
"Food",64058,"Ongoing","Unified Grocers Inc.","City Of Commerce","CA","US","Voluntary: Firm Initiated","Letter","WA, OR","F-0949-2013","Class I","Kinnikinnick Foods Pie Crusts, 10.2 oz, Item code: 21-35265, UPC 6-20133-00600.","Lot code: BB2013DE12 ",".","5 cases (30 units)","Unified Grocers is recalling Kinnikinnick Pie Crust because it contains undeclared egg allergen.",12/31/2012,"12/31/2012",2/6/2013,"02/06/2013"
"Food",64059,"Ongoing","KeHE/Tree of life Bloomington","Bloomington","IN","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","MN and PA","F-0943-2013","Class I","Kinnikinnick Pie Crust (frozen) Weight: 290 g/10 oz Qty/Pkg: 2 UPC: 62013300600 9","BB2013DE13",".","5 cases/6 packages per case","Kinnikinnick Foods, Inc in Edmonton, Alberta Canada indicated that KeHE Distributors in Bloomington, IN had received pie crusts in association with their recall/allergy alert issued 12/28-29/2012",1/4/2013,"01/04/2013",2/6/2013,"02/06/2013"
"Biologics",64060,"Terminated","Talecris Plasma Resources Inc","Research Triangle Park","NC","US","Voluntary: Firm Initiated","Telephone","North Carolina","B-1005-13","Class II","Source Plasma","3580167569; 3580167563; 3580167559; 3580167571; 3580167556; 3580167561; 3580167570; 3580168680; 3580168682; 3580168671; 3580168689; 3580168669; 3580168688; 3580168687; ",".","14","Blood products, which were not tested for viral markers, were distributed.",9/21/2012,"09/21/2012",5/15/2013,"05/15/2013"
"Veterinary",64061,"Ongoing","Del Monte Foods Corp","San Francisco","CA","US","Voluntary: Firm Initiated","E-Mail","Nationally to >200 consignees","V-196-2013","Class II","All Sizes Milo's Kitchen home style dog treats - Chicken Jerky 3.3 oz UPC 079100504718, 14 oz. UPC 079100510771, 20 oz. UPC 079100504688","UPC:079100504718; UPC:079100510771; UPC:079100504688",".","1.97 MM ","On 01/07/2013, New York State's Department of Agriculture informed the U.S. Food and Drug Administration (FDA) and the Company that trace amounts of residual antibiotics had been found in several lots of MiIo's Kitchen Chicken Jerky and Chicken Grillers. After consultation with the New York Department of Agriculture and FDA, the company decided to voluntarily recall Milos Kitchen Chicken Jerky and Chicken Grillers, which are both sourced from the same chicken suppliers.",1/9/2013,"01/09/2013",6/19/2013,"06/19/2013"
"Veterinary",64061,"Ongoing","Del Monte Foods Corp","San Francisco","CA","US","Voluntary: Firm Initiated","E-Mail","Nationally to >200 consignees","V-197-2013","Class II","All Sizes: Milo's Kitchen brand Chicken Grillers home style dog treats; Chicken Recipe with natural smoked flavor. 3.3 oz UPC 079100513109; 14 oz. UPC 079100513123; 20 oz UPC 079100513130.","UPC ITEM CODES: UPC 079100513109; UPC 079100513123; UPC 079100513130",".",".43 MM cases","On 01/07/2013, New York State's Department of Agriculture informed the U.S. Food and Drug Administration (FDA) and the Company that trace amounts of residual antibiotics had been found in several lots of MiIo's Kitchen Chicken Jerky and Chicken Grillers. After consultation with the New York Department of Agriculture and FDA, the company decided to voluntarily recall Milo's Kitchen Chicken Jerky and Chicken Grillers, which are both sourced from the same chicken suppliers.",1/9/2013,"01/09/2013",6/19/2013,"06/19/2013"
"Drugs",64062,"Ongoing","Hospira Inc.","Lake Forest","IL","US","Voluntary: Firm Initiated","Letter","Nationwide","D-159-2013","Class II","Propofol Injectable Emulsion, 1%, packaged in a) 20 mL Single patient infusion vial, 200 mg/20 mL (10 mg/mL), NDC 0409-4699-30; b) 50 mL Single patient infusion vial, 500 mg/50 mL (10 mg/mL), NDC 0409-4699-33; c) 100 mL Single patient infusion vial, 1 g/100 mL (10 mg/mL), NDC 0409-4699-24; Rx only, Hospira, Inc., Lake Forest, IL 60045 USA ","Lot #: a) 95-070-DJ, Exp 11/01/12; 04-584-DJ, 04-652-DJ, Exp 04/01/13; 05-718-DJ, Exp 05/01/13; 06-815-DJ, Exp 06/01/13; b) 04-525-DJ, 04-530-DJ, 04-641-DJ-04-646-DJ, Exp 04/01/13; c) 02-291-DJ, Exp 02/01/13; 05-725-DJ, 05-732-DJ, Exp 05/01/13; 07-925-DJ, Exp 07/01/13; 09-065-DJ, Exp 09/01/13; 10-129-DJ, 10-133-DJ, 10-148-DJ, Exp 10/01/13, Note lot number may be followed by 01. ",,"273,925 vials","Presence of Particulate Matter: Visible particulate and particulate embedded in vials were observed during retain inspection.",11/15/2012,"11/15/2012",2/20/2013,"02/20/2013"
"Devices",64063,"Ongoing","Siemens Healthcare Diagnostics, Inc.","Newark","DE","US","Voluntary: Firm Initiated","Letter","Nationwide Distribution","Z-0933-2013","Class III","Siemens Total Iron Binding Capacity (IBCT) Flex Reagent Cartridge. An in vitro diagnostic test intended to quantitatively measure Total Iron Binding Capacity in human serum. ","Siemens Material Number (SMN) 10444944, Catalog number DF84 -- lot numbers BA3016, EXP 2013-01-16; EC3045, EXP 2013-02-14; EA3073, EXP 2013-03-14; DC3102, EXP 2013-04-12; FC3122, EXP 2013-05-02; EA3157, EXP 2013-06-06; BB3184, EXP 2013-07-03; EC3219, EXP 2013-08-07; EC3220, EXP 2013-08-08; GA3248, 2013-09-05; and FB3290, EXP 2013-10-17",,"19, 503 cartons","The analytical sensitivity claim of 6 ug/dL (1.1 umol/L) in the Instructions for Use (IFU) is no longer valid. Siemens is conducting a voluntary corrective action for Dimension Total Iron Binding Capacity (IBCT) to modify the analytical sensitivity claim to 36 ug/dL (6.44 umol/L).",12/20/2012,"12/20/2012",3/20/2013,"03/20/2013"
"Veterinary",64064,"Ongoing","IMS Trading Corp.","Wood Ridge","NJ","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Nationwide.","V-207-2013","Class II","Companion Chicken Breast Fillet Jerky Strips Dog Treats a) Net Wt 3.3 oz (94 g) . UPC 688267076862 b) Net Wt 14 oz (397g) UPC 688267077449 Distributed by Foodhold USA, LLC Landover, MD 20785 Product of China","All codes",".","3.3 oz - 17,280 units; 14 oz. - 13,260 units","NYSDAM Analysis has revealed the presence of unapproved antibiotics in Cadet Gourmet Chicken Breast Pet Treats.",1/8/2013,"01/08/2013",6/19/2013,"06/19/2013"
"Veterinary",64064,"Ongoing","IMS Trading Corp.","Wood Ridge","NJ","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Nationwide.","V-204-2013","Class II","Cadet Gourmet Chicken Breast a) Net Wt. 3.6 oz UPC 768303074929 b) Net Wt. 8 oz. UPC 768303074936 c) Net Wt. 1 Lb (454 g) tub - UPC 768303014352 UPC 768303014703 d) Net Wt. 1.25 Lb (567 g) UPC 768303014741 e) Net Wt. 1.5 Lb (681 g) UPC 768303014161 f) Net. Wt. 2.0 lb. UPC 768303014727 Product of China Not for Human Consumption. Distributed by: IMS Pet Industries, Inc., 34 Passaic Street, Wood-Ridge, NJ 07075 ","All codes",".","3.6 oz - 17,408 units; 8 oz. - 3,403 units; 1 lb. - 21540 units; 1.25 lb. -198 units; 1.5 lb - 300 units; 2.0 lb- 19,261 units ","NYSDAM Analysis has revealed the presence of unapproved antibiotics in Cadet Gourmet Chicken Breast Pet Treats.",1/8/2013,"01/08/2013",6/19/2013,"06/19/2013"
"Veterinary",64064,"Ongoing","IMS Trading Corp.","Wood Ridge","NJ","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Nationwide.","V-205-2013","Class II","Shep Chicken Breast Fillets Net Wt. 3.5 oz (99g) Net Wt. 3. oz (99g) Product of China. Not for Human Consumption. Distributed by: ALDI Inc. Batavia, IL 60510-1477","All codes",".","159,744 units; ","NYSDAM Analysis has revealed the presence of unapproved antibiotics in Cadet Gourmet Chicken Breast Pet Treats.",1/8/2013,"01/08/2013",6/19/2013,"06/19/2013"
"Veterinary",64064,"Ongoing","IMS Trading Corp.","Wood Ridge","NJ","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Nationwide.","V-206-2013","Class II","Home 360 Pet Chicken Breast Fillets Oven Roasted a) Net Wt. 3.5 oz (99g) UPC 725439966429 b) Net Wt. 1 Lb (454 g) UPC 725439966436 Product of China. Not for Human Consumption. Distributed by: DZA Brands, LLC 2110 Executive Drive, Salisbury, NC 28147 Product of China","All codes",".",,"NYSDAM Analysis has revealed the presence of unapproved antibiotics in Cadet Gourmet Chicken Breast Pet Treats.",1/8/2013,"01/08/2013",6/19/2013,"06/19/2013"
"Biologics",64066,"Terminated","Central Texas Regional Blood & Tissue Center","Austin","TX","US","Voluntary: Firm Initiated","FAX","Texas","B-0950-13","Class II","Platelets Pheresis Leukocytes Reduced","W221612616122; ",,"1 unit","Blood product, collected that did not have WBC QC testing for contamination, was distributed. ",11/30/2012,"11/30/2012",4/17/2013,"04/17/2013"
"Biologics",64067,"Terminated","Bergen Comm Reg Blood Center","Paramus","NJ","US","Voluntary: Firm Initiated","FAX","NJ","B-0922-13","Class II","Platelets Pheresis Leukocytes Reduced","W065612049423",".","1 unit","Blood product, which did not meet acceptable product specifications, was distributed.",12/14/2012,"12/14/2012",5/29/2013,"05/29/2013"
"Biologics",64068,"Terminated","Ortho Clinical Diagnostics Inc","Raritan","NJ","US","Voluntary: Firm Initiated","Letter","Multiple U.S. States - CA, MI, DC, TN, OK, PA, LA, WI, WA, OH, WV","B-0819-13","Class III","Blood Grouping Reagent, Anti-e (Monoclonal)","SEB382A",".","21 Vials","Blood Grouping Reagent Anti-e (Monoclonal) BioClone, with potential of false negative results, was distributed.",12/18/2012,"12/18/2012",3/27/2013,"03/27/2013"
"Devices",64069,"Ongoing","Allergen Medical","Medford","MA","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution-USA including the states of CA, FL, GA, MI, MN, NJ, NY, OH, OR, RI, TX, VA, and WA, and the countries of Germany, Spain, and UK.","Z-0794-2013","Class II","SeriScaffold Surgical Scaffold Product Number: SCF10X25AGEN. Surgical mesh for use in open or laparoscopic procedures.","Lot Numbers: P2012040901 (US) P2011080101B and P2011090901A (Outside the US)",,"225 units (US) and 81 (Outside US)","Product is dual packaged in an inner and outer pouch, the outer pouch seal may be compromised and sterility may not be assured",1/8/2013,"01/08/2013",2/13/2013,"02/13/2013"
"Devices",64070,"Ongoing","Philips Healthcare Inc.","Andover","MA","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution - US Nationwide and the countries of: AUSTRALIA, AUSTRIA, BELGIUM,CANADA, CHILE, DENMARK, FRANCE GERMANY, ICELAND, INDIA, IRELAND,ISRAEL,ITALY, JORDAN, KENYA KUWAIT, LEBANON, MALAYSIA, NAMIBIA, NETHERLANDS, NEW ZEALAND NORWAY,PALESTINE, POLAND,PORTUGAL, SAUDI ARABIA, SINGAPORE SLOVENIA, SOUTH AFRICA, SOUTH KOREA,SPAIN,SWEDEN, SWITZERLAND THAILAND, TRINIDAD AND TOBAGO, UNITED ARAB EMIRATES UNITED KINGDOM","Z-0824-2013","Class II","Philips Healthcare SureSigns VS2+ Model 863278 SureSigns VS2+ NBP and SpO2 Model 863279 SureSigns VS2+ NBP, SpO2 and Temperature Product Usage: The SureSigns VS2+ vital signs monitor is for monitoring, recording and alarming of multiple physiological parameters of adults, pediatrics, and neonates in healthcare environments. Additionally, the monitor is intended for use in transport situations within a healthcare facility. ","Serial Numbers: CN14800428, CN14800429, CN14800430, CN14800431, CN14800432, CN14800433, CN14800434, CN14800435, CN14800436, CN14800437, CN14800438, CN14800439, CN14800440, CN14800756, CN14800763, CN14800764, CN14800765, CN14800772, CN14800773, CN14800822, CN14800823, CN14800824, CN14800979, CN14801332, CN21201423, CN21201625, CN21202029, CN21202030, CN21202031, CN21202032, CN21202033, CN21202034, CN21202234, CN21202239, CN21202240, CN21202241, CN21202242, CN21202243, CN21202317, CN21202320, CN21202347, CN21202348, CN21202349, CN21202350, CN21202351, CN21202376, CN21202435, CN21202606, CN21202607, CN21202862, CN21202863, CN21202883, CN21203006, CN21203007, CN21203008, CN21203009, CN21203010, CN21203073, CN21203180, CN21203304, CN21203307, CN21203308, CN21203309, CN21203310, CN21203311, CN21203312, CN21203707, CN21203781, CN21203794, CN21203795, CN21203796, CN21203797, CN21203949, CN21203950, CN21203951, CN21203952, CN21203953, CN21204204, CN21204205, CN21204206, CN21204207, CN21204208, CN21204209, CN21204210, CN21204211, CN21203057, CN14800484, CN14800744, CN14800745, CN14800746, CN21203044, CN21203045, CN21203068, CN21203069, CN21203070, CN21203071, CN14800485, CN14800486, CN14800749, CN14800750, CN14800751, CN14800752, CN14800770, CN14800771, CN14800893, CN21201756, CN21201757, CN21201758, CN21201759, CN21201760, CN21202164, CN21202165, CN21202166, CN21202167, CN21202168, CN21202169, CN21202170, CN21202171, CN21202172, CN21202173, CN21202174, CN21202175, CN21202176, CN21202177, CN21202178, CN21202202, CN21202610, CN21202864, CN21203209, CN21203210, CN21203639, CN14801200, CN14801201, CN14801202, CN14801203, CN14801204, CN14801205, CN14801206, CN14801207, CN14801208, CN14801209, CN14801210, CN14801212, CN14801213, CN14801217, CN14801278, CN14801279, CN14801280, CN14801281, CN21201576, CN21201613, CN21202313, CN21202367, CN21202368, CN21202371, CN21202657, CN21203072, CN21203416, CN21203887, CN21203961, CN21203970, CN21204148, CN21204318, CN21202393, CN21202394, CN21203746, CN21203747, CN21203748, CN21203749, C"," CN21203848, CN21203849, CN21203850, CN21203851, CN21203852, CN21203853, CN21203854, CN21203855, CN21203856, CN21203857, CN21203858, CN21203859, CN21203860, CN21203861, CN21203862, CN21203863, CN21203864, CN21203865, CN21203866, CN21203867, CN21203868, CN21203869, CN21203886, CN21203926, CN21203927, CN21203928, CN21203938, CN21203939, CN21203940, CN21203941, CN21203942, CN21203943, CN21203944, CN21203945, CN21203967, CN21203968, CN21203969, CN21204005, CN21204013, CN21204029, CN21204030, CN21204031, CN21204032, CN21204033, CN21204034, CN21204035, CN21204036, CN21204037, CN21204038, CN21204039, CN21204040, CN21204041, CN21204049, CN21204050, CN21204051, CN21204052, CN21204053, CN21204054, CN21204055, CN21204056, CN21204057, CN21204058, CN21204059, CN21204060, CN21204061, CN21204062, CN21204063, CN21204064, CN21204065, CN21204066, CN21204067, CN21204068, CN21204069, CN21204070, CN21204071, CN21204072, CN21204073, CN21204074, CN21204075, CN21204076, CN21204077, CN21204078, CN21204079, CN21204080, CN21204081, CN21204082, CN21204083, CN21204084, CN21204085, CN21204086, CN21204087, CN21204088, CN21204089, CN21204090, CN21204091, CN21204092, CN21204093, CN21204094, CN21204095, CN21204096, CN21204097, CN21204098, CN21204099, CN21204100, CN21204101, CN21204119, CN21204131, CN21204134, CN21204144, CN21204145, CN21204201, CN21204202, CN21204224, CN21204226, CN21204283, CN21204284, CN21204285, CN21204286, CN21204287, CN21204292, CN21204309, CN21204310, CN21204311, CN21204312, CN21204317, CN21204322, SP13701043, USPP101007, CN21201390, CN21201500, CN21201501, CN21201502, CN21201503, CN21201505, CN21201506, CN21201507, CN21201508, CN21201509, CN21201510, CN21201511, CN21201512, CN21201513, CN21201514, CN21201515, CN21201516, CN21201517, CN21201518, CN21201519, CN21201520, CN21201521, CN21201522, CN21201523, CN21201524, CN21201525, CN21201526, CN21201527, CN21201528, CN21201529, CN21201530, CN21201531, CN21201532, CN21201533, CN21201534, CN21201535, CN21201536, CN21201537, CN21201538, CN21201539, CN21201540, CN21201541, CN21","3248 units","VS2+ screen may lock up and stop monitoring during patient use",1/14/2013,"01/14/2013",2/20/2013,"02/20/2013"
"Devices",64071,"Ongoing","GE Healthcare, LLC","Waukesha","WI","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution - USA including the states of AR, CA, CO, FL, GA, IL IN, IA, LA, MD, MA, MI, MN, MO, NJ, NM, NY, NC, OH, OK, PA, PR, SC, SD, TN, TX and VA. and the countries of ALGERIA, AUSTRALIA, AUSTRIA, ARGENTINA, BELARUS, CANADA, CHINA, CHILE, EGYPT CZECH REPUBLIC, FRANCE, FINLAND, GERMANY, GABON, HONG KONG, INDIA, IRELAND, ITALY KENYA, KOREA, JAPAN, MEXICO, NIGERIA, PHILIPPINES, PORTUGAL REPUBLIC OF MALTA, RUSSIAN FEDERATION SAUDI ARABIA, SPAIN SWITZERLAND, TURKEY, TAIWAN, TUNISIA, UNTIED KINGDOM and VENEZUELA.","Z-0901-2013","Class II","GE Healthcare Volume Viewer Plus 5.x (Advantage Workstation 4.2) Volume Viewer 3.x (Advantage Workstation 4.1) Volume Analysis (Advantage Workstation 4.0) Volume Analysis (Advantage Workstation 3.1) Advantage Windows Volume Rendering Option is intended to provide fast, easy, volume visualization of three dimensional structures imaged with a computed tomography (CT) or magnetic resonance (MR) system. It is dedicated to clinical and diagnostic applications in radiology, surgery, and treatment planning.","000000010009GS 000000010017GS 000000010049GS 000000010045GS 000000010001GS 000000010030GS 000000010004GS 000000010062GS 000000010054GS 000000010028GS 000000010005GS 000000010086GS 000000010002GS 00000L026FFE60 00000L0271A594 000000010081GS 000000010041GS 000000010024GS 000000010026GS 000000010043GS 000000010072GS 000000010079GS 000000010082GS 000000010057GS 000000010051GS 000000010071GS 000000010064GS 000000010073GS 000000010077GS 000000010038GS 000000010053GS 000000010047GS 000000010033GS 000000010094GS 000000010050GS 000000010021GS 000000010015GS 00000L0219C835 000000010059GS 000000010012GS 000000010018GS 000000010060GS 000000010003GS 000000010008GS 000000010014GS 000000010020GS 000000010075GS 000000010074GS 00000L0274A04C 000000010022GS 000000010048GS 000000010067GS 000000010063GS 000000010087GS 000000010034GS 000000010083GS 000000010036GS 000000010080GS 000000010044GS 000000010006GS 000000010068GS 000000010027GS 000000010091GS 000000010032GS 000000010029GS 000000010078GS 000000010007GS 000000010013GS 000000010090GS 000000010065GS 000000010016GS 000000010055GS 000000010069GS 000000010076GS 000000010052GS 000000010025GS 000000010092GS 000000010070GS 000000010089GS 000000010046GS 00000LEE1BC41D 000000010042GS 000000010061GS 000000010066GS 00000L0236B9CE 00000LEE1BC908 00000L023A0E34 00000L02019460 00000L02019ABA 00000L025B5C0C 00000LEE17087C 00000L610029DF 00000LEE1A72F8 00000L02374674 00000L025871B4 00000LEE1AA670 00000L6100BCF6 00000L61009728 00000L02167EAD 00000LEE1AD7CE 00000LEE170AEC 00000L6100B3FF 00000L6100C191 00000L022E0038 00000L0237474C 00000LEE1AD631 00000LEE1BC30A 00000L0235D1DC 00000L6100C520 00000L6100B968 00000L6100BCA9 00000L0265F43C 00000L6100BE7F 00000L0201485E 00000L0236B9CC 00000L0268E922 00000L020730A2 00000L0233B384 00000L025ADA52 00000L6100C4DC 00000L6100974C 00000L6100B69C 00000L0207263E 00000L6100BFE0 00000L0201994E 00000LEE1AD74B 00000L0235B34E 00000L025A17EE 00000LEE1AD7CD 00000L6100C4E1 00000L61009E1D 00000L0201521E 00000LEE170AC1 00000L0265F603 00000L0265FAEC 00000LEE1AD80B 00000",,"363","Incorrect views and measurements possible. GE Healthcare became aware of multiple potential safety issues involving the Advantage workstation, Volume Viewer Plus and Volume Analysis.",5/25/2012,"05/25/2012",3/13/2013,"03/13/2013"
"Devices",64072,"Ongoing","DePuy Spine, Inc.","Raynham","MA","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution-USA (nationwide) and the countries of Argentina, Armenia, Kazakhstan, Russia, Ukraine, Australia, Austria Belgium, Luxembourg , Brazil, Canada, China, Colombia, Cyprus, Jordan Lebanon, Saudi Arabia, UAE, Czech Republic, Finland ,France, Germany, Greece, Hong Kong, Hungary, India, Ireland, Israel, Italy, Latvia, Malaysia Mexico, Netherlands, New Zealand, Norway, Sweden, Poland, Portugal Singapore, Slovakia, Slovenia, South Africa, Spain, Switzerland, Turkey, and UK.","Z-0961-2013","Class II","DePuy CONFIDENCE SPINAL CEMENT SYSTEM 7CC KITCatalog Number: 283907000. Delivery of CONFIDENCE Spinal Cement, which is indicated for fixation of pathological fractures. ","All lots",".","549","Cement mixer used to prepare cement for surgery may not turn properly and may jam or stuck",1/15/2013,"01/15/2013",3/27/2013,"03/27/2013"
"Devices",64072,"Ongoing","DePuy Spine, Inc.","Raynham","MA","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution-USA (nationwide) and the countries of Argentina, Armenia, Kazakhstan, Russia, Ukraine, Australia, Austria Belgium, Luxembourg , Brazil, Canada, China, Colombia, Cyprus, Jordan Lebanon, Saudi Arabia, UAE, Czech Republic, Finland ,France, Germany, Greece, Hong Kong, Hungary, India, Ireland, Israel, Italy, Latvia, Malaysia Mexico, Netherlands, New Zealand, Norway, Sweden, Poland, Portugal Singapore, Slovakia, Slovenia, South Africa, Spain, Switzerland, Turkey, and UK.","Z-0963-2013","Class II","DePuy CONFIDENCE SPINAL CEMENT SYSTEM KITCatalog Number: 283913000. Delivery of CONFIDENCE Spinal Cement, which is indicated for fixation of pathological fractures. ","All lots",".","6668 ","Cement mixer used to prepare cement for surgery may not turn properly and may jam or stuck",1/15/2013,"01/15/2013",3/27/2013,"03/27/2013"
"Devices",64072,"Ongoing","DePuy Spine, Inc.","Raynham","MA","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution-USA (nationwide) and the countries of Argentina, Armenia, Kazakhstan, Russia, Ukraine, Australia, Austria Belgium, Luxembourg , Brazil, Canada, China, Colombia, Cyprus, Jordan Lebanon, Saudi Arabia, UAE, Czech Republic, Finland ,France, Germany, Greece, Hong Kong, Hungary, India, Ireland, Israel, Italy, Latvia, Malaysia Mexico, Netherlands, New Zealand, Norway, Sweden, Poland, Portugal Singapore, Slovakia, Slovenia, South Africa, Spain, Switzerland, Turkey, and UK.","Z-0960-2013","Class II","DePuy CONFIDENCE SPINAL CEMENT SYSTEM 5CC KITCatalog Number:283905000. Delivery of CONFIDENCE Spinal Cement, which is indicated for fixation of pathological fractures. ","All lots",".","1023","Cement mixer used to prepare cement for surgery may not turn properly and may jam or stuck",1/15/2013,"01/15/2013",3/27/2013,"03/27/2013"
"Devices",64072,"Ongoing","DePuy Spine, Inc.","Raynham","MA","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution-USA (nationwide) and the countries of Argentina, Armenia, Kazakhstan, Russia, Ukraine, Australia, Austria Belgium, Luxembourg , Brazil, Canada, China, Colombia, Cyprus, Jordan Lebanon, Saudi Arabia, UAE, Czech Republic, Finland ,France, Germany, Greece, Hong Kong, Hungary, India, Ireland, Israel, Italy, Latvia, Malaysia Mexico, Netherlands, New Zealand, Norway, Sweden, Poland, Portugal Singapore, Slovakia, Slovenia, South Africa, Spain, Switzerland, Turkey, and UK.","Z-0962-2013","Class II","DePuy CONFIDENCE SPINAL CEMENT SYSTEM 11C Plus KITCatalog Number: 283910000. Delivery of CONFIDENCE Spinal Cement, which is indicated for fixation of pathological fractures. ","All lots",".","7773","Cement mixer used to prepare cement for surgery may not turn properly and may jam or stuck",1/15/2013,"01/15/2013",3/27/2013,"03/27/2013"
"Biologics",64073,"Terminated","Florida Lions Eye Bank, Inc.","Miami","FL","US","Voluntary: Firm Initiated","Letter","Ohio; Florida; Texas, North Carolina","B-0815-13","Class II","Cornea","0804057COD; 0804057COS; 0806022COS; 0806022COD; 0808025COD; 0808025COS; 0808052COD; 0808052COS; 0810073COD; 0810073COS; 0812022COS; 0812022COD; 0905018COD; 0905018COS; 1004080COD; 1004080COSG1; 1004080COSG2; 1005014COD; 1005014COS; 1006028COD; 1006028COS; 1006046CODG1; 1006046CODG2; 1006046COS; 1007046COD; 1007046COS",".","26","Human Corneal tissues, recovered from donors and not tested using appropriate FDA-licensed, approved, or cleared donor screening tests, in accordance with the manufacturer's instructions, to adequately and appropriately reduce the risk of transmission of relevant communicable disease agents or diseases, were distributed.",11/19/2012,"11/19/2012",3/27/2013,"03/27/2013"
"Biologics",64073,"Terminated","Florida Lions Eye Bank, Inc.","Miami","FL","US","Voluntary: Firm Initiated","Letter","Ohio; Florida; Texas, North Carolina","B-0816-13","Class III","Cornea","1005010CODG1, 1005010CODG2, 1005010COSG1, 1005010COSG2, 1005010SODW, 1005010SOSW",".","6","Human Corneal tissues, recovered from donors and not tested using appropriate FDA-licensed, approved, or cleared donor screening tests, in accordance with the manufacturer's instructions, to adequately and appropriately reduce the risk of transmission of relevant communicable disease agents or diseases, were distributed.",11/19/2012,"11/19/2012",3/27/2013,"03/27/2013"
"Biologics",64074,"Terminated","Community Blood Centers of Florida, Inc.","Lauderhill","FL","US","Voluntary: Firm Initiated","Letter","New York","B-0987-13","Class II","Red Blood Cells","8405574; ",,"1","Blood product, collected from a donor in whom donor suitability was not adequately determined, was distributed.",12/24/2012,"12/24/2012",5/8/2013,"05/08/2013"
"Devices",64075,"Ongoing","Viscot Medical LLC","East Hanover","NJ","US","Voluntary: Firm Initiated","Letter","USA Nationwide Distribution","Z-1025-2013","Class III"," Dual Tip Marker, Sterile Product Usage: A writing instrument intended to mark paper and plastic items around the sterile field during surgery. It has two tips. One is black for miscellaneous use. The other is for surgical skin marking. ","Lot# 022043, 022045, 022046, 042084, 042085, 042086, 042087, 042088, 042089, 052128, 052129, 052130, 052131, 062167, 062168, 062169, 062170, 072200, 072201, 072203, 072205, 072206, 072207 (Including any letter suffixes after lot #).",".","458,589 markers","Dual Tip Marker has inconsistent ink flow on the black permanent ink side.",8/22/2012,"08/22/2012",4/10/2013,"04/10/2013"
"Devices",64076,"Ongoing","International Technidyne Corp.","Edison","NJ","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution - USA (nationwide) and Internationally to Bermuda, Canada, Chile, Denmark, Germany,Italy,Latvia, Lithuania, Malaysia, Phillipines, South Africa, Spain, Switzerland, Taiwan, and United Arab Emirates.","Z-0837-2013","Class II","Pro Time Microcoagulation System/ Pro Time 3 Cuvette International Technidyne Corporation 23 Nevsky Street Edison, NJ 08820 The Pro Time Microcoagulation System is a portable batter operated instrument with a disposable cuvette for quantitative determination of prothrombin time from fingerstick whole blood or anticoagulant free venous whole blood.","Pro3-25 A2K3C001 1/31/2013 A2K3C002 1/31/2013 A2P3C003 1/31/2013 A2P3C004 1/31/2013 A2K3C005 1/31/2013 A2K3C006 1/31/2013 A2K3C007 1/31/2013 A2K3C008 1/31/2013 A2K3C009 1/31/2013 A2K3C011 1/31/2013 A2K3C013 1/31/2013 A2K3C015 1/31/2013 A2K3C016 1/31/2013 A2K3C017 1/31/2013 A2K3C018 1/31/2013 A2K3C019 1/31/2013 A2K3C020 1/31/2013 A2K3C021 1/31/2013 A2K3C022 1/31/2013 A2K3C023 1/31/2013 2K3C024 1/31/2013 A2K3C025 1/31/2013 A2K3C026 1/31/2013 A2K3C027 1/31/2013 B2K3C028 2/28/2013 B2K3C030 2/28/2013 B2K3C031 2/28/2013 B2K3C032 2/28/2013 B2K3C033 2/28/2013 B2K3C034 2/28/2013 B2K3C035 2/28/2013 B2K3C036 2/28/2013 B2K3C037 2/28/2013 B2K3C038 2/28/2013 B2K3CO39 2/28/2013 B2K3C040 2/28/2013 B2K3C041 2/28/2013 B2K3C042 2/28/2013 B2K3C043 2/28/2013 B2K3C044 2/28/2013 B2K3C045 2/28/2013 B2K3C046 2/28/2013 C2K3C048 3/31/2013 C2K3C049 3/31/2013 C2K3C050 3/31/2013 C2K3C051 3/31/2013 C2K3C052 3/31/2013 C2K3C053 3/31/2013 C2K3C054 3/31/2013 C2K3C055 3/31/2013 C2K3C056 3/31/2013 C2K3C058 3/31/2012 C2K3C059 3/31/2013 C2K3C061 3/31/2013 D2K3C078 4/30/2013 M1K3C474 12/31/2012 M1K3C475 12/31/2012 M1K3C477 12/31/2012 M1P3C478 12/31/2012 M1P3C479 12/31/2012 M1P3C480 12/31/2012 M1P3C481 12/31/2012 M1P3C482 12/31/2012 PRO3-4 A2K3H015 1/31/2013 B2K3H029 2/28/2013 B2K3H033 2/28/2013 B2K3H047 2/28/2013 C2K3H049 3/31/2013 C2K3H055 3/31/2013 C2K3H057 3/31/2013 PRO3-50 B2P3C029 2/28/2013 B2P3C030 2/28/2013 B2O3C033 2/28/2013 C2P3C057 3/31/2013",".","11742 boxes US (25 cuvettes per box); 22,968 boxes OUS (25 cuvettes per box)","Some Pro Time3 Test Cuvettes within a specified lot range may recover lower than expected Prothrombin Time/International Normalized Ratio (PT/INR) results.",9/28/2012,"09/28/2012",2/27/2013,"02/27/2013"
"Devices",64078,"Completed","Merit Medical Systems, Inc.","Chester","VA","US","Voluntary: Firm Initiated","Letter","Germany","Z-1660-2013","Class II","Custom Procedural Trays: Merit's Custom Angio Kits A custom procedural tray is a combination of legally marketed medical devices placed into one container for the convenience of the user and used within the limits of the product's intended uses. Contained within the tray are hand controller sheaths which are intended to enable increased flow control (when compared to hand injection) but with the feel of a hand syringe. It provides more control over the total volume delivered by allowing the physician to adjust contrast delivery during the injection and monitor total volume delivered to the patient.","Merit's Custom Angio kits K09T-09812B and K09T-09812C, Lot numbers T252244, T318352, T342249, T359185",".","134 trays","Custom Procedural trays contain Medrad Hand Controller Sheaths which were recalled because the seal between the white polyethylene and the clear plastic may be missing on the package resulting in a potential breach of the sterility of this accessory.",11/21/2012,"11/21/2012",7/10/2013,"07/10/2013"
"Food",64080,"Ongoing","Jiffy Food Service, LLC","Chelsea","MI","US","Voluntary: Firm Initiated","E-Mail","Nationwide including Arizona, California, Colorado, Connecicut, Florida, Georgia, Idaho, Illinois, Kentucky, Louisiana, Michigan, Missouri, Montana, New England, New Jersey, New Mexico, Nevada, Oklahoma, Pennsylvania, South Dakota, Tennessee, Texas, Utah, Virgina and Wisconsin.","F-0941-2013","Class I","Spice Cake Mix , 25 lb. and 50 lb. kraft bags, labelled a) CMC Quality and Value, Spice Cake Mix, 46702-00985, NET Wt. 25 lbs. (11.34 kg) JIFFY Foodservice, LLC, Chelsea, Michigan 48188; b) CMC Quality and Value, Spice Cake Mix, 46702-00920, NET Wt. 50 lbs. (22.68 kg.), JIFFY Foodservice, LLC, Chelsea, Michigan 48188.","UPC Code 84670200985 Manufacturing Date Codes (printed on the inside seam/gusset of the bag): 08/01/2012, 08/23/2012, 10/03/2012, 11/18/2012, 11/19/2012.",".","7,422 bags (total 25 lb. and 50 lb. combined)","Undeclared Allergen (Milk). Firm initiated a voluntary recall of their 25 lb. and 50 lb. bags of Spice Cake Mix that had been distributed since August 2012 due to an undeclared allergen, milk. The Spice Cake Mix is manufactured for correctional facilities/institutions only.",1/11/2013,"01/11/2013",2/6/2013,"02/06/2013"
"Devices",64081,"Ongoing","Siemens Healthcare Diagnostics, Inc.","Newark","DE","US","Voluntary: Firm Initiated","Letter","Nationwide Distribution.","Z-0745-2013","Class III","Dimension(R) IRON Calibrator (DC85), Siemens material number 10445010. The Dimension(R) IRON Calibrator is an in vitro diagnostic product intended to be used to calibrate the Iron method for the Dimension(R) clinical chemistry system.","Siemens material number 10445010 -- and lot numbers 2DN060, exp 2013-10-01; 2FN063, exp 2013-12-01; 2GN068, exp 2014-01-01; and 2JN073, exp 2014-03-01.",".","5999","Siemens Healthcare Diagnostics has received complaints of IRON calibrations outside of acceptable calibration slope (m) values (0.97 - 1.03) when using IRON calibrator lots 2DN060 and 2FN063. Lots 2GN068 and 2JN074 may also be impacted but no complaints have been received.",12/20/2012,"12/20/2012",2/6/2013,"02/06/2013"
"Food",64082,"Completed","Gordon Food Service, Inc.","Plant City","FL","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Florida only","F-0952-2013","Class II","***GFS***CLAW MEAT***Wild-Caught and Hand-Picked***PASTEURIZED CRAB***Carne de mano de jaiba*** NET WT/PESO NETO***16 OZ (1 LB) 453g***Reorder #536030***PRODUCT OF THAILAND***.","Product ID# 536030, best by Feb 12 2013",".","10 cases ","Concern with Time/Temperature abused during transit.",12/13/2012,"12/13/2012",2/6/2013,"02/06/2013"
"Drugs",64083,"Ongoing","Hospira, Inc.","Rocky Mount","NC","US","Voluntary: Firm Initiated","Letter","Nationwide","D-169-2013","Class II","Furosemide Injection USP (10 mg/mL), 4 mL in 5 mL Fliptop Vial, Rx only, Hospira Inc., Lake Forest, IL --- NDC 0409-6102-04","18-099-DK",,"63,900 vials","Lack of Assurance of Sterility; possible loose crimp applied to fliptop vial",1/10/2013,"01/10/2013",3/6/2013,"03/06/2013"
"Devices",64084,"Completed","Custom Healthcare Systems, Inc.","Richmond","VA","US","Voluntary: Firm Initiated","Letter","USA Nationwide Distribution including the states GA, OH, GA, NC and ME.","Z-0796-2013","Class II","Custom Breast Biopsy Tray, Catalog # B 9-16261, packaged in bags, 1 tray/bag, 20 bags/case. Product Usage: A sterile medical device containing multiple components utilized by physician to perform a breast biopsy. ","LOT NO. 100212 EXPIRES: 06/2013",,"80 trays","Surgical procedure trays are packed with pharmaceuticals for injection that may contain particulate matter.",11/26/2012,"11/26/2012",2/13/2013,"02/13/2013"
"Devices",64084,"Completed","Custom Healthcare Systems, Inc.","Richmond","VA","US","Voluntary: Firm Initiated","Letter","USA Nationwide Distribution including the states GA, OH, GA, NC and ME.","Z-0797-2013","Class II","Custom Breast Biopsy Tray w/Sodium Chloride, Catalog # B9-15263A, packaged in bags, 1 tray/bag, 20 bags/case. Product Usage: A sterile medical device containing multiple components utilized by physician to perform a breast biopsy. ","LOT NO. 60812 EXPIRES: 11 /2012",,"80 trays","Surgical procedure trays are packed with pharmaceuticals for injection that may contain particulate matter.",11/26/2012,"11/26/2012",2/13/2013,"02/13/2013"
"Drugs",64085,"Ongoing","Upsher Smith Laboratories, Inc.","Maple Grove","MN","US","Voluntary: Firm Initiated","Telephone","Nationwide and Puerto Rico","D-127-2013","Class III","Divalproex Sodium Delayed-Release Tablets, USP, 500 mg Valproic Acid Activity, 100-count tablets per bottle, Rx only, Manufactured by Upsher-Smith Laboratories, Inc., Minneapolis, MN 55447, NDC 0245-0182-11.","Lot #: 310162, Exp 09/14",".","11,316 bottles","Labeling: Label Error On Declared Strength; Some bottles of product were missing the color-coded strength on the primary display panel of the label.",12/10/2012,"12/10/2012",1/23/2013,"01/23/2013"
"Food",64086,"Ongoing","Island Delights, Inc.","Seville","OH","US","Voluntary: Firm Initiated","Telephone","Product was shipped to the following states: AZ, CA, FL, MA, MN, MS, NC, NY, OH, SC, TX, VA, WA & WY.","F-0945-2013","Class I","Island Delights Almond Chocolate/Almond Mix Natural Flavor Coconut Haystacks, NET WEIGHT 2 oz, 4 oz, 8 oz and 2 lb clear plastic bags. Bags labeled in part ''INGREDIENTS: SUGAR, COCONUT***COCOA***NATURAL ALMOND FLAVOR***Island Delights, Inc., Seville, OH 44273''","2 oz, Lot #13413100.02, UPC Code 0 19694 71020 1 4 oz, Lot #13413100.04, UPC Code 0 19694 71040 9 8 oz, Lot #13413100.08, UPC Code 0 19694 71080 5 2 lb, Lot #13413100.00, no bar code",".","12/2 oz bags, 26/4 oz bags, 13/8 oz bags & 2/2 lb bags","During a visual inspection from Ohio Dept of Agriculture the firm was notified that they did not list milk in their ingredient statement.",1/8/2013,"01/08/2013",2/6/2013,"02/06/2013"
"Food",64086,"Ongoing","Island Delights, Inc.","Seville","OH","US","Voluntary: Firm Initiated","Telephone","Product was shipped to the following states: AZ, CA, FL, MA, MN, MS, NC, NY, OH, SC, TX, VA, WA & WY.","F-0947-2013","Class I","Island Delights ALMOND Natural Flavor Coconut Haystacks, NET WEIGHT 2 oz, 4 oz, 8 oz and 2 lb clear plastic bags. Bags labeled in part ''INGREDIENTS: SUGAR, COCONUT***COCOA***NATURAL COFFEE FLAVOR***Island Delights, Inc., Seville, OH 44273''","2 oz, Lot #13413000.02, UPC Code 0 19694 70020 2 4 oz, Lot #13413000.04, UPC Code 0 19694 70040 0 8 oz, Lot #13413000.08, UPC Code 0 19694 70080 6 2 lb, Lot #13413002.00, no bar code",".","1/2 oz bag, 4/4oz bags, 5/8 oz bags = 10 bags","During a visual inspection from Ohio Dept of Agriculture the firm was notified that they did not list milk in their ingredient statement.",1/8/2013,"01/08/2013",2/6/2013,"02/06/2013"
"Food",64086,"Ongoing","Island Delights, Inc.","Seville","OH","US","Voluntary: Firm Initiated","Telephone","Product was shipped to the following states: AZ, CA, FL, MA, MN, MS, NC, NY, OH, SC, TX, VA, WA & WY.","F-0946-2013","Class I","Island Delights COFFEE NATURAL Natural Flavor Coconut Haystacks, NET WEIGHT 2 oz, 4 oz, 8 oz and 2 lb clear plastic bags. Bags labeled in part ''INGREDIENTS: SUGAR, COCONUT***COCOA***NATURAL COFFEE FLAVOR***Island Delights, Inc. Seville, OH 44273''","2 oz, Lot #13411300.02, UPC Code 0 19694 60020 5 4 oz, Lot #13411300.04, UPC Code 0 19694 60040 3 8 oz, Lot #13411300.08, UPC Code 0 19694 60080 9",".","24/4 oz bags & 38/8 oz bags = 62 bags","During a visual inspection from Ohio Dept of Agriculture the firm was notified that they did not list milk in their ingredient statement.",1/8/2013,"01/08/2013",2/6/2013,"02/06/2013"
"Food",64086,"Ongoing","Island Delights, Inc.","Seville","OH","US","Voluntary: Firm Initiated","Telephone","Product was shipped to the following states: AZ, CA, FL, MA, MN, MS, NC, NY, OH, SC, TX, VA, WA & WY.","F-0944-2013","Class I","Island Delights Coconut Haystack Candy Maple Natural Flavor Coconut Haystacks, NET WEIGHT 2 OZ, 4 oz and 8 oz clear plastic bags. Bags labeled in part ''INGREDIENTS: SUGAR, COCONUT***NATURAL MAPLE FLAVOR***Island Delights, Inc. Seville, OH 44273''","2 oz, Lot #13410400.02, UPC Code 0 19694 19020 1 4 oz, Lot #13410400.04, UPC Code 0 19694 19040 9 8 oz, Lot #13410400.08, UPC Code 0 19694 19080 5 2 lb, Lot #13410402.00, no bar code",".","45/2 oz bags, 207/4 oz bags, 50/8 oz bags & 13/2 lb bags = 315 BAGS","During a visual inspection from Ohio Dept of Agriculture the firm was notified that they did not list milk in their ingredient statement.",1/8/2013,"01/08/2013",2/6/2013,"02/06/2013"
"Biologics",64087,"Terminated","The Children's Hospital Assoc. Transfusion Medicine Services","Aurora","CO","US","Voluntary: Firm Initiated","Telephone","Colorado","B-0408-13","Class II","Whole Blood","W140512443683; ",".","1","Blood product, collected from an autologous donor but incorrectly labeled as a homologous unit, was distributed.",12/4/2012,"12/04/2012",5/15/2013,"05/15/2013"
"Biologics",64088,"Terminated","Mid-South Regional Blood Center","Memphis","TN","US","Voluntary: Firm Initiated","Telephone","Tennessee","B-1008-13","Class II","Platelets Pheresis Leukocytes Reduced","W227712044243; W227712044243; ",".","2","Blood products, with pH below the acceptable level, were distributed.",12/10/2012,"12/10/2012",5/15/2013,"05/15/2013"
"Biologics",64089,"Terminated","Hemacare Corporation","Van Nuys","CA","US","Voluntary: Firm Initiated","Letter","California","B-1010-13","Class II","Platelets Pheresis Leukocytes Reduced Irradiated","W313712015322; ",".","1","Blood product, collected from a donor who reported travel to a malarial endemic area, was distributed.",12/17/2012,"12/17/2012",5/15/2013,"05/15/2013"
"Biologics",64090,"Terminated","Community Blood Center Of Gtr KC","Kansas City","MO","US","Voluntary: Firm Initiated","Telephone","Missouri","B-1011-13","Class III","Red Blood Cells Leukocytes Reduced Washed","W045012093999; ",".","1","Blood product, with an unacceptably low red cell recovery rate, was distributed.",11/26/2012,"11/26/2012",5/15/2013,"05/15/2013"
"Devices",64091,"Ongoing","Hospira Inc.","Lake Forest","IL","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution - USA (nationwide) including states of: AK, AL, AR, AZ, CA, CO, CT, DE, FL, GA, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, SI, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV, WY, District of Columbia, Puerto Rico and U.S. Virgin Islands; and countries of: Croatia, Dominican Republic, Turks and Caicos.","Z-0206-2014","Class II","Plum A+3 Infusion Pump System; List Number: 12348; Product Usage: The Plum A+ Infusion Systems are a multipurpose family of devices that provides precise delivery of multiple therapies across the general spectrum of clinical care ","List No. 12348; Serial Numbers: 13740156 , 13740256 , 13740266 , 13740351 , 13740380 , 13740451 , 13740508 , 13740612 , 13740632 , 13740731 , 13740732 , 13740733 , 13740734 , 13740735 , 13740736 , 13740737 , 13740738 , 13740739 , 13740740 , 13740741 , 13740742 , 13740743 , 13740744 , 13740745 , 13740746 , 13740747 , 13740748 , 13740749 , 13740750 , 13740751 , 13740752 , 13740753 , 13740754 , 13740755 , 13740756 , 13740757 , 13740758 , 13740759 , 13740760 , 13740761 , 13740762 , 13740763 , 13740764 , 13740765 , 13740766 , 13740767 , 13740768 , 13740769 , 13740770 , 13740771 , 13740772 , 13740773 , 13740774 , 13740775 , 13740776 , 13740777 , 13740778 , 13740779 , 13740780 , 13740781 , 13740782 , 13740783 , 13740784 , 13740785 , 13740786 , 13740787 , 13740788 , 13740789 , 13740790 , 13740791 , 13740792 , 13740793 , 13740794 , 13740795 , 13740796 , 13740797 , 13740798 , 13740799 , 13740800 , 13740801 , 13740802 , 13740803 , 13740804 , 13740805 , 13740806 , 13740807 , 13740808 , 13740809 , 13740810 , 13740811 , 13740812 , 13740813 , 13740814 , 13740815 , 13740816 , 13740818 , 13740819 , 13740820 , 13740821 , 13740822 , 13740823 , 13740824 , 13740825 , 13740826 , 13740827 , 13740828 , 13740829 , 13740830 , 13740831 , 13740832 , 13740833 , 13740834 , 13740835 , 13740836 , 13740837 , 13740838 , 13740839 , 13740840 , 13740841 , 13740842 , 13740843 , 13740844 , 13740845 , 13740846 , 13740847 , 13740848 , 13740849 , 13740850 , 13740851 , 13740852 , 13740853 , 13740854 , 13740855 , 13740856 , 13740857 , 13740858 , 13740859 , 13740860 , 13740861 , 13740862 , 13740863 , 13740864 , 13740865 , 13740866 , 13740867 , 13740868 , 13740869 , 13740870 , 13740871 , 13740872 , 13740873 , 13740874 , 13740875 , 13740876 , 13740877 , 13740878 , 13740879 , 13740880 , 13740881 , 13740882 , 13740883 , 13740884 , 13740885 , 13740886 , 13740887 , 13740888 , 13740889 , 13740890",".","List No. 12348: 214 units","Hospira has received reports of distal pressure sensor calibration drift on Plum A+ Infusers. The following error codes may be displayed during setup or infusion signifying possible calibration drift: E180/N180, E181/N181, E186/N186, E187/N187 or E346. Additionally, if the pressure sensor calibration has drifted, users may experience false distal occlusion alarms or distal occlusions that may not be detected. These errors invoke visual and audible warnings to the user. Hospira has identified the following design attributes of the pressure sensor that may cause the calibration to drift sooner than expected: strain gage protective layers' moisture resistance issues, pressure assembly chassis residual structural stress issues, and relaxation of clamping force from mounting screws for strain gage and pin stack.",2/5/2012,"02/05/2012",11/20/2013,"11/20/2013"
"Devices",64091,"Ongoing","Hospira Inc.","Lake Forest","IL","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution - USA (nationwide) including states of: AK, AL, AR, AZ, CA, CO, CT, DE, FL, GA, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, SI, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV, WY, District of Columbia, Puerto Rico and U.S. Virgin Islands; and countries of: Croatia, Dominican Republic, Turks and Caicos.","Z-0203-2014","Class II","Plum A+ Hyperbaric Infusion Pump; List Number 11005; Labeled in part: PLUM A+ HYPERBARIC; Product Usage: The Plum A+ Infusion Systems are a multipurpose family of devices that provides precise delivery of multiple therapies across the general spectrum of clinical care ","List No. 11005; Serial Numbers: 16792201, 16792202, 16792205, 16792206, 16792208, 16792209, 16792210, 16792211, 16792213, 16792216, 16792217, 16792219, 16792220, 16792222, 16792223, 16792224, 16792225, 16792226, 16792227, 16792228, 16792230, 16792232, 16792233, 16792234, 16792235, 16792236, 16792238, 16792239, 16792240, 16792241, 16792242, 16792244, 16792245, 16792246, 16792248, 16792249, 16792250, 16792251, 16792252, 16792253, 16792254, 16792255, 16792256, 16792257, 16792258, 16792259, 16792260, 16792261, 16792263, 16792264, 16792265, 16792266, 16792268, 16792269, 16792271, 16792272, 16792273, 18807402, 18807405, 18807406, 18807407, 18807408, 18807409, 18807410, 18807413, 18807414, 18807417, 18807418, 18807420, 18807421, 18807423, 18807427, 18807428, 18807429, 18807430, 18807431, 18807432, 18807433, 18807434, 18807439, 18807443, 18807444, 18807446, 18807449, 18807452, 18807453, 18807455, 18807456, 18807459, 18807463, 18807466, 18807472, 18807474, 18807478, 18807484, 18807485, 18807486, 18807490, 18807491, 18807494, 18807496, 18807499, 18807500, 18807501, 18807506, 18807509, 18807510, 18807511, 18807513, 18807514, 18807518, 18807523, 18807524, 18807529, 18807535, 18807536, 18807539, 18807540, 18807541, 18807542, 18807543, 18807545, 18807546, 18807556, 18807557, 18807568, 18807574, 18807575, 18807576, 18807578, 18807581, 18807584, 18807585, 18807586, 18807588, 18807589, 18807590, 18807591, 18807596, 18807597, 18807598, 18807599, 18807600, 18807601, 18807602, 18807604, 18807605, 18807607, 18807608, 18807609, 18807610, 18807611, 18807612, 18807613, 18807614, 18807617, 18807618, 18807619, 18807620, 18807623, 18807625, 18807626, 18807627, 18807628, 18807630, 18807631, 18807632, 18807633, 18807634, 18807636, 18807637, 18807639, 18807640, 18807695, 18807696, 18807697, 18807698, 18807699, 18807700 ",".","List No. 11005: 179 units","Hospira has received reports of distal pressure sensor calibration drift on Plum A+ Infusers. The following error codes may be displayed during setup or infusion signifying possible calibration drift: E180/N180, E181/N181, E186/N186, E187/N187 or E346. Additionally, if the pressure sensor calibration has drifted, users may experience false distal occlusion alarms or distal occlusions that may not be detected. These errors invoke visual and audible warnings to the user. Hospira has identified the following design attributes of the pressure sensor that may cause the calibration to drift sooner than expected: strain gage protective layers' moisture resistance issues, pressure assembly chassis residual structural stress issues, and relaxation of clamping force from mounting screws for strain gage and pin stack.",2/5/2012,"02/05/2012",11/20/2013,"11/20/2013"
"Devices",64091,"Ongoing","Hospira Inc.","Lake Forest","IL","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution - USA (nationwide) including states of: AK, AL, AR, AZ, CA, CO, CT, DE, FL, GA, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, SI, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV, WY, District of Columbia, Puerto Rico and U.S. Virgin Islands; and countries of: Croatia, Dominican Republic, Turks and Caicos.","Z-0209-2014","Class II","*** 1) Plum A+ Infusion Pump; List Number: 20678; Labeled in part: PLUM A+3; for use with Hospira MedNet; *** 2) Plum A+ Infusion Pump; List Number: 20679; Labeled in part: PLUM A+; for use with Hospira MedNet; *** 3) Plum A+ Infusion Pump with Hospira MedNet Software; List Number: 20792; Labeled in part: PLUM A+; for use with Hospira MedNet; Product Usage: The Plum A+ Infusion Systems are a multipurpose family of devices that provides precise delivery of multiple therapies across the general spectrum of clinical care ","Excessive data in the Code Information for this product has caused issues with the CSV download function. The complete list of Code Information can be found at the Addendum to Enforcement Report.",".","1) List No. 20678: 21,551 units; 2) List No. 20679: 7,737 units; 3) List No. 20792: 126,696 units ","Hospira has received reports of distal pressure sensor calibration drift on Plum A+ Infusers. The following error codes may be displayed during setup or infusion signifying possible calibration drift: E180/N180, E181/N181, E186/N186, E187/N187 or E346. Additionally, if the pressure sensor calibration has drifted, users may experience false distal occlusion alarms or distal occlusions that may not be detected. These errors invoke visual and audible warnings to the user. Hospira has identified the following design attributes of the pressure sensor that may cause the calibration to drift sooner than expected: strain gage protective layers' moisture resistance issues, pressure assembly chassis residual structural stress issues, and relaxation of clamping force from mounting screws for strain gage and pin stack.",2/5/2012,"02/05/2012",11/20/2013,"11/20/2013"
"Devices",64091,"Ongoing","Hospira Inc.","Lake Forest","IL","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution - USA (nationwide) including states of: AK, AL, AR, AZ, CA, CO, CT, DE, FL, GA, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, SI, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV, WY, District of Columbia, Puerto Rico and U.S. Virgin Islands; and countries of: Croatia, Dominican Republic, Turks and Caicos.","Z-0208-2014","Class II","Plum A+ Infusion Pump; List Number: 12618; Product Usage: The Plum A+ Infusion Systems are a multipurpose family of devices that provides precise delivery of multiple therapies across the general spectrum of clinical care ","Excessive data in the Code Information for this product has caused issues with the CSV download function. The complete list of Code Information can be found at the Addendum to Enforcement Report.",".","List No. 12618: 7,691 units","Hospira has received reports of distal pressure sensor calibration drift on Plum A+ Infusers. The following error codes may be displayed during setup or infusion signifying possible calibration drift: E180/N180, E181/N181, E186/N186, E187/N187 or E346. Additionally, if the pressure sensor calibration has drifted, users may experience false distal occlusion alarms or distal occlusions that may not be detected. These errors invoke visual and audible warnings to the user. Hospira has identified the following design attributes of the pressure sensor that may cause the calibration to drift sooner than expected: strain gage protective layers' moisture resistance issues, pressure assembly chassis residual structural stress issues, and relaxation of clamping force from mounting screws for strain gage and pin stack.",2/5/2012,"02/05/2012",11/20/2013,"11/20/2013"
"Devices",64091,"Ongoing","Hospira Inc.","Lake Forest","IL","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution - USA (nationwide) including states of: AK, AL, AR, AZ, CA, CO, CT, DE, FL, GA, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, SI, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV, WY, District of Columbia, Puerto Rico and U.S. Virgin Islands; and countries of: Croatia, Dominican Republic, Turks and Caicos.","Z-0207-2014","Class II","Plum A+ Infusion Pump; List Number: 12391; Product Usage: The Plum A+ Infusion Systems are a multipurpose family of devices that provides precise delivery of multiple therapies across the general spectrum of clinical care ","Excessive data in the Code Information for this product has caused issues with the CSV download function. The complete list of Code Information can be found at the Addendum to Enforcement Report.",".","List No. 12391: 182,970 units","Hospira has received reports of distal pressure sensor calibration drift on Plum A+ Infusers. The following error codes may be displayed during setup or infusion signifying possible calibration drift: E180/N180, E181/N181, E186/N186, E187/N187 or E346. Additionally, if the pressure sensor calibration has drifted, users may experience false distal occlusion alarms or distal occlusions that may not be detected. These errors invoke visual and audible warnings to the user. Hospira has identified the following design attributes of the pressure sensor that may cause the calibration to drift sooner than expected: strain gage protective layers' moisture resistance issues, pressure assembly chassis residual structural stress issues, and relaxation of clamping force from mounting screws for strain gage and pin stack.",2/5/2012,"02/05/2012",11/20/2013,"11/20/2013"
"Devices",64091,"Ongoing","Hospira Inc.","Lake Forest","IL","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution - USA (nationwide) including states of: AK, AL, AR, AZ, CA, CO, CT, DE, FL, GA, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, SI, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV, WY, District of Columbia, Puerto Rico and U.S. Virgin Islands; and countries of: Croatia, Dominican Republic, Turks and Caicos.","Z-0205-2014","Class II","Plum A+ Infusion Pump; List Number: 11973; Product Usage: The Plum A+ Infusion Systems are a multipurpose family of devices that provides precise delivery of multiple therapies across the general spectrum of clinical care ","List No. 11973; Serial Numbers: 12570148 , 12570150 , 12570154 , 12570163 , 12570170 , 12570177 , 12570204 , 12570211 , 12570212 , 12570255 , 12570270 , 12570319 , 12570359 , 12570385 , 12570413 , 12570425 , 12570455 , 12570487 , 12570662 , 12570695 , 12570854 , 12570915 , 12571080 , 12571243 , 12571437 , 12571631 , 12571692 , 12571776 , 12571826 , 12571835 , 12571837 , 12571842 , 12571877 , 12571880 , 12571886 , 12572317 , 12572369 , 12572586 , 12572909 , 12573547 , 12573567 , 12573837 , 12573990 , 12574424 , 12574501 , 12574524 , 12574556 , 12574599 , 12574619 , 12574731 , 12574749 , 12574853 , 12574858 , 12574860 , 12574865 , 12574961 , 12575626 , 12575698 , 12575886 , 12576125 , 12576443 , 12576485 , 12576518 , 12576593 , 12576609 , 12576710 , 12576722 , 12577271 , 12577685 , 12578856 , 12579183 ",".","List No. 11973: 71 units","Hospira has received reports of distal pressure sensor calibration drift on Plum A+ Infusers. The following error codes may be displayed during setup or infusion signifying possible calibration drift: E180/N180, E181/N181, E186/N186, E187/N187 or E346. Additionally, if the pressure sensor calibration has drifted, users may experience false distal occlusion alarms or distal occlusions that may not be detected. These errors invoke visual and audible warnings to the user. Hospira has identified the following design attributes of the pressure sensor that may cause the calibration to drift sooner than expected: strain gage protective layers' moisture resistance issues, pressure assembly chassis residual structural stress issues, and relaxation of clamping force from mounting screws for strain gage and pin stack.",2/5/2012,"02/05/2012",11/20/2013,"11/20/2013"
"Devices",64091,"Ongoing","Hospira Inc.","Lake Forest","IL","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution - USA (nationwide) including states of: AK, AL, AR, AZ, CA, CO, CT, DE, FL, GA, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, SI, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV, WY, District of Columbia, Puerto Rico and U.S. Virgin Islands; and countries of: Croatia, Dominican Republic, Turks and Caicos.","Z-0204-2014","Class II","Plum A+ Infusion Pump; List Number: 11971; Product Usage: The Plum A+ Infusion Systems are a multipurpose family of devices that provides precise delivery of multiple therapies across the general spectrum of clinical care ","Excessive data in the Code Information for this product has caused issues with the CSV download function. The complete list of Code Information can be found at the Addendum to Enforcement Report.",".","List No. 11971: 10,669 units","Hospira has received reports of distal pressure sensor calibration drift on Plum A+ Infusers. The following error codes may be displayed during setup or infusion signifying possible calibration drift: E180/N180, E181/N181, E186/N186, E187/N187 or E346. Additionally, if the pressure sensor calibration has drifted, users may experience false distal occlusion alarms or distal occlusions that may not be detected. These errors invoke visual and audible warnings to the user. Hospira has identified the following design attributes of the pressure sensor that may cause the calibration to drift sooner than expected: strain gage protective layers' moisture resistance issues, pressure assembly chassis residual structural stress issues, and relaxation of clamping force from mounting screws for strain gage and pin stack.",2/5/2012,"02/05/2012",11/20/2013,"11/20/2013"
"Food",64092,"Ongoing","Homestead Creamery","Jamesport","MO","US","Voluntary: Firm Initiated","Telephone","The product was distributed to stores in MO and an open farmer's market in gift baskets. Exact dates of the start of distribution are not clear. The plastic packaging film used to package the recalled product is supplied by: Specialty Foods, Roland Park, KS. The Annato cheese food coloring, cheese cultures and Rennet are supplied by, Dairy Connections, Madison, WI.","F-1009-2013","Class I","Homestead Creamery Artisan Cheese, Flory's Favorite, whole raw jersey milk, packaged in 1-lb or 1/2-lb block/plastic packs.","label marked with: Packed On 210",,"4/20-lb blocks cut into smaller 1-lb and 1/2-lb packages","The raw milk cheese product may be contaminated with shiga-toxin e-coli.",1/11/2013,"01/11/2013",3/6/2013,"03/06/2013"
"Biologics",64093,"Terminated","Blood Assurance Inc","Chattanooga","TN","US","Voluntary: Firm Initiated","FAX","Tennessee","B-1012-13","Class II","Red Blood Cells Leukocytes Reduced","P60990; ",".","1","Blood product, collected from a donor considered to be at increased risk for variant Creutzfeldt-Jakob Disease (vCJD), was distributed.",1/4/2013,"01/04/2013",5/15/2013,"05/15/2013"
"Biologics",64094,"Terminated","Lane Memorial Blood Bank","Eugene","OR","US","Voluntary: Firm Initiated","FAX","Oregon","B-1013-13","Class II","Red Blood Cells Leukocytes Reduced","W137512111712; W137512107157; ",".","2","Blood products, collected from a donor who reported travel to a malarial endemic area, were distributed",1/3/2013,"01/03/2013",5/15/2013,"05/15/2013"
"Biologics",64095,"Terminated","Blood Assurance Inc","Chattanooga","TN","US","Voluntary: Firm Initiated","FAX","Tennessee","B-1014-13","Class II","Red Blood Cells (Apheresis) Leukocytes Reduced","W04211091240; W04211091240; ",".","2","Blood products, collected from a donor whose suitability to donate was not adequately determined, were distributed.",12/11/2012,"12/11/2012",5/15/2013,"05/15/2013"
"Biologics",64096,"Terminated","Talecris Plasma Resources, Inc.","Research Triangle Park","NC","US","Voluntary: Firm Initiated","FAX","North Carolina","B-1015-13","Class II","Source Plasma","3270201511; 3270200643; 3270200313; 3270198380; 3270198053; 3270197360; 3270196575; 3270196161; 3270193616; 3270192348; 3270191920; 3270191241; 3270190571; 3270190209; 3270189435; 3270189193; 3270188499; 3270188060; 3270187611; 3270186965; 3270186130; 3270185752; 3270185277; 3270184766; 3270184130; 3270183856; 3270179389; 3270178907; 3270177534; ",".","29","Blood products, collected from a donor who received a tattoo within 12 months of donating, were distributed.",11/30/2012,"11/30/2012",5/15/2013,"05/15/2013"
"Biologics",64097,"Terminated","Jubilant HollisterStier, LLC","Spokane","WA","US","Voluntary: Firm Initiated","Letter","Multiple U.S. States; Philippines, Bermuda, India, Hong Kong, Japan, South Korea, Jamaica, Brazil","B-1150-13","Class III","Custom Patient Prescriptions","T12003022, T12003259, T12003260, T12003261, T12005541, T12003052, T12003212, T12007935, T12003055, T12007934, T12005543, T12003309, T12003290, T12005559, T12005560, T12005561, T12005824, T12005832, T12005833, T12005836, T12006132, T12006134, T12006136, T12006140, T12006142, T12006148, T12007600, T12007603, T12007604, T12007605, T12007610, T12005860, T12007138, T12007142, T12007146, T12002944, T12006685, T12002947, T12005534, T12005536, T12005539, T12007657, T12007926, T12007929, T12003220, T12007562, T12002866, T12003053, T12002871, T12002872, T12005850, T12006625, T12005585, T12005588, T12005590, T12005596, T12005597, T12005600, T12005615, T12005624, T12005867, T12005869, T12005870, T12005873, T12006167, T12006674, T12007645, T12007652, T12003262, T12002902, T12002904, T12003235, T12007955, T12006120, T12006125, T12006815, T12006816, T12006874, T12006877, T12006878, T12007030, T12007031, T12007039, T12007044, T12007159, T12007156, T12007157, T12003255, T12003258, T12007560, T12007990, T12007993, T12003251, T12003226, T12003242, T12005565, T12006113, T12006630, T12007957, T12003266, T12002846, T12002895, T12002908, T12006869, T12006991, T12006994, T12006996, T12007001, T12007003, T12007006, T12007076, T12007615, T12002900, T12002911, T12002913, T12002914, T12002915, T12005568, T12005572, T12005841, T12005842, T12005845, T12006626, T12006628, T12006634, T12007991, T12003240, T12003049, T12003050, T12006641, T12006644, T12006645, T12006665, T12006762, T12006883, T12006885, T12006888, T12006889, T12006892, T12006934, T12006935, T12006936, T12006938, T12006939, T12006948, T12007066, T12007631, T12007985, T12007989, T12003023, T12003214, T12006151, T12006624, T12006130, T12002853, T12003296, T12002924, T12002925, T12005854, T12005855, T12006154, T12006159, T12006160, T12006635, T12006647, T12006648, T12006649, T12006650, T12006652, T12006653, T12006654, T12007625, T12007919, T12007980, T12003005, T12003437, T12002949, T12003230, T12003268, T12007013, T12007015, T12007049, T12007127, T12007128, T12002989, T12003425,",,"62","Allergenic Extracts, with confirmed OOS potency results at 15 month stability time point, were distributed. ",1/14/2013,"01/14/2013",4/3/2013,"04/03/2013"
"Biologics",64097,"Terminated","Jubilant HollisterStier, LLC","Spokane","WA","US","Voluntary: Firm Initiated","Letter","Multiple U.S. States; Philippines, Bermuda, India, Hong Kong, Japan, South Korea, Jamaica, Brazil","B-1149-13","Class III","Insects (Whole Body), Mite Dermatophagoides farinae","E1203031; E1201566; E1201592; E1201780; E1202429; E1202633; E1204095; E1202443; E1202442; E1202056; E1203032; E1202002; E1202615; E1203147; E1201608; E1202612; E1202737; E1203047; E1202193; E1202045; E1201457; E1201884; E1201270; E1202518; E1202021; E1201356; E1202349; E1202240; E1202059; E1202444; E1201567; E1201774; E1202634; E1202060; E1202445; E1201713; E1201714; E1201775; E1202062; E1201711; E1201779; E1201676; E1201677; E1201726; E1202063; E1201702; E1201727; E1202061; E1202057; E1202094; E1202072; E1202058; E1202446; E1203164; E1201484; E1202074; E1202574; E1202575; E1202656; E1201635; E1202573; E1202073",,"62","Allergenic Extracts, with confirmed OOS potency results at 15 month stability time point, were distributed. ",1/14/2013,"01/14/2013",4/3/2013,"04/03/2013"
"Biologics",64098,"Terminated","Bio-Blood Components, Inc.","Gary","IN","US","Voluntary: Firm Initiated","E-Mail","Tennessee","B-1016-13","Class III","Source Plasma","12GINB4552; ",".","1","Blood product, collected from a donor whose suitability to donate was not adequately determined, was distributed.",11/30/2012,"11/30/2012",5/15/2013,"05/15/2013"
"Devices",64099,"Ongoing","Tobii Assistive Technology, Inc.","Dedham","MA","US","Voluntary: Firm Initiated","Letter","US Nationwide Distribution","Z-0766-2013","Class II","P10 Tobii battery box (product number 510410) Product Usage - Battery pack for MyTobii P10 Device. MyTobii P10 is a portable eye-controlled communication device featuring the Tobii Eye Control system.","Product Code 510410, all units.",,"483 units","Tobii ATI customers P10 external battery pack, which contains sealed lead-acid batteries, malfunctioned while recharging and produced smoke with a chemical smell.",1/14/2013,"01/14/2013",2/13/2013,"02/13/2013"
"Drugs",64100,"Ongoing","West-ward Pharmaceutical Corp.","Eatontown","NJ","US","Voluntary: Firm Initiated","Letter","GA, AR","D-220-2013","Class II","Ciprofloxacin Tablets USP, 500 mg, 100-count bottle, Rx only, Manufactured for West-ward Pharmaceutical Corp., Eatowntown, NJ 07724 by Hikma Pharmaceuticals, Amman, Jordan, NDC 0143-9928-01","Lot #: CB222A, Exp 06/16",,"7,136 units","Presence of Foreign Substance(s): A complaint was received for a rubber-like material in a 500 mg Ciprofloxacin tablet.",2/6/2013,"02/06/2013",4/3/2013,"04/03/2013"
"Food",64101,"Ongoing","Dawn's Foods, Inc.","Portage","WI","US","Voluntary: Firm Initiated","FAX","IL, IA, WI","F-0954-2013","Class II","Ocean Harbor Cajun Krab Spread Net Wt 5 lb (2.27 kg) UPC: 0 32345-77711 8 Dist by Roundy's Inc.","1/9/13 -3/05/13",".","3,130 lbs","Dawn's Foods, inc. is conducting a voluntary recall of certain seafood products packaged in 5# and 10 oz. containers. This is being done with the abundance of cation due to the fact that we cannot exclude the possibility that the affected sizes may be a viable environment for pathogen growth.",1/11/2013,"01/11/2013",2/6/2013,"02/06/2013"
"Food",64101,"Ongoing","Dawn's Foods, Inc.","Portage","WI","US","Voluntary: Firm Initiated","FAX","IL, IA, WI","F-0957-2013","Class II","Five Star Dip Cajun Krab Dip Net Wt 10 oz (284g). UPC: 0 32345 84063 8, Mfg By Dawns Foods, Inc., Portage, WI 53901. 84080 Dawns Cajun Krab Dip NET WT 5 LBS (2.27 kg), UPC: 0 32345 88888 3 MFG BY DAWN'S FOODS, INC., PORTAGE, WI 53901","1/9/13 -3/05/13",".","4,176 lbs","Dawn's Foods, inc. is conducting a voluntary recall of certain seafood products packaged in 5# and 10 oz. containers. This is being done with the abundance of cation due to the fact that we cannot exclude the possibility that the affected sizes may be a viable environment for pathogen growth.",1/11/2013,"01/11/2013",2/6/2013,"02/06/2013"
"Food",64101,"Ongoing","Dawn's Foods, Inc.","Portage","WI","US","Voluntary: Firm Initiated","FAX","IL, IA, WI","F-0953-2013","Class II","Ocean Harbor Smoked Salmon Spread Net Wt 5 lb.(2.27 kg). UPC: 0 32345-77707 1 Dist by Roundy's Inc.","1/9/13 -3/05/13",".","6,940 lbs","Dawn's Foods, inc. is conducting a voluntary recall of certain seafood products packaged in 5# and 10 oz. containers. This is being done with the abundance of cation due to the fact that we cannot exclude the possibility that the affected sizes may be a viable environment for pathogen growth.",1/11/2013,"01/11/2013",2/6/2013,"02/06/2013"
"Food",64101,"Ongoing","Dawn's Foods, Inc.","Portage","WI","US","Voluntary: Firm Initiated","FAX","IL, IA, WI","F-0958-2013","Class II","Dawns Alaskan Krab and Shrimp Salad NET WT 5 LBS (2.27 kg), UPC: 0 32345 70103 8 MFG BY DAWN'S FOODS, INC., PORTAGE, WI 53901 Ocean Harbor Krab and Shrimp Salad NET WT 5 LBS (2.27 kg), UPC: 0 32345 77701 9 Dist by Roundy's Inc.","1/9/13 -2/19/13",".","7,470 lbs","Dawn's Foods, inc. is conducting a voluntary recall of certain seafood products packaged in 5# and 10 oz. containers. This is being done with the abundance of cation due to the fact that we cannot exclude the possibility that the affected sizes may be a viable environment for pathogen growth.",1/11/2013,"01/11/2013",2/6/2013,"02/06/2013"
"Food",64101,"Ongoing","Dawn's Foods, Inc.","Portage","WI","US","Voluntary: Firm Initiated","FAX","IL, IA, WI","F-0956-2013","Class II","Five Star Dip Smoked Salmon Dip Net WT 10 oz (284g). UPC: 0 32345 61463 5 Mfg By Dawn Food, Portage, WI 53901. Dawns Smoked Salmon Dip NET WT 5 LBS (2.27 kg) UPC: 0 32345 61480 2 MFG BY DAWN'S FOODS, INC., PORTAGE, WI 53901","1/9/13 -3/05/13",".","11,841 lbs","Dawn's Foods, inc. is conducting a voluntary recall of certain seafood products packaged in 5# and 10 oz. containers. This is being done with the abundance of cation due to the fact that we cannot exclude the possibility that the affected sizes may be a viable environment for pathogen growth.",1/11/2013,"01/11/2013",2/6/2013,"02/06/2013"
"Food",64101,"Ongoing","Dawn's Foods, Inc.","Portage","WI","US","Voluntary: Firm Initiated","FAX","IL, IA, WI","F-0955-2013","Class II","Ocean Harbor Jalapeno Krab Spread Net Wt 5 lbs (2.27kg) UPC: 0 32345-77715 6 Dist by Roundy's Inc.","1/9/13 -3/05/13",".","1,250 lbs","Dawn's Foods, inc. is conducting a voluntary recall of certain seafood products packaged in 5# and 10 oz. containers. This is being done with the abundance of cation due to the fact that we cannot exclude the possibility that the affected sizes may be a viable environment for pathogen growth.",1/11/2013,"01/11/2013",2/6/2013,"02/06/2013"
"Food",64101,"Ongoing","Dawn's Foods, Inc.","Portage","WI","US","Voluntary: Firm Initiated","FAX","IL, IA, WI","F-0959-2013","Class II","Dawns Alaskan Krab Salad NET WT 5 LBS (2.27 kg), UPC: 0 32345 85072 9 , MFG BY DAWN'S FOODS, IN., PORTAGE, WI 53901 Ocean Harbor Alaskan Krab Salad NET WT 5 LBS (2.27 kg), UPC: 0 32345 77705 7, Dist by Roundy's Inc.","1/9/13 -2/19/13",".","10,635 lbs","Dawn's Foods, inc. is conducting a voluntary recall of certain seafood products packaged in 5# and 10 oz. containers. This is being done with the abundance of cation due to the fact that we cannot exclude the possibility that the affected sizes may be a viable environment for pathogen growth.",1/11/2013,"01/11/2013",2/6/2013,"02/06/2013"
"Drugs",64102,"Ongoing","Fresenius Kabi USA LLC (FK USA)","Schaumburg","IL","US","Voluntary: Firm Initiated","Letter","Nationwide","D-915-2013","Class II","IRINOTECAN HYDROCHLORIDE INJECTION, 40 mg/2 mL (20 mg/mL), 2 mL Single Dose Vial, Rx only, Manufactured for: APP Pharmaceuticals, LLC, Schaumburg, IL 60173, NDC 63323-193-02, UPC 3 63323 19302 7.","Lot #: 872CZ00101, Exp 12/13",".","23,672 vials","Crystallization: Active pharmaceutical ingredient is precipitating in product solution.",1/22/2013,"01/22/2013",8/28/2013,"08/28/2013"
"Drugs",64103,"Ongoing","West-ward Pharmaceutical Corp.","Eatontown","NJ","US","Voluntary: Firm Initiated","Letter","Nationwide","D-150-2013","Class II","Carisoprodol Tablets, USP, 350 mg, packaged in a) 500-count tablets per bottle (NDC 0143-1176-05) and b) 1000-count tablets per bottle (NDC 0143-1176-10), Rx only, Manufactured by: West-ward Pharmaceutical Corp., Eatontown, NJ 07724.","Lot #: 69364A, 69365A, and 69365B, Exp 10/15",,"8,585 bottles","Presence of Foreign Substance: Uncharacteristic blacks spots on tablets.",12/7/2012,"12/07/2012",2/13/2013,"02/13/2013"
"Drugs",64104,"Ongoing","West-ward Pharmaceutical Corp.","Eatontown","NJ","US","Voluntary: Firm Initiated","Letter","Nationwide","D-201-2013","Class III","Carisoprodol Tablets, USP, 350 mg Rx Only, 100 tablets per bottle, Rx Only, Manufactured by: West-ward Pharmaceutical Corp., Eatontown, NJ 07724, NDC 0143-1176-01.","Lot #: 69160A",".","1763 bottles","Labeling: Not elsewhere classified: On 12/12/11, DEA published a final rule in the Federal Register making this product a schedule IV (C-IV)controlled substance. This product is being recalled because this controlled product was not relabeled with the required ''C-IV'' imprint on the label for products distributed after the 06/11/12 deadline.",11/30/2012,"11/30/2012",3/27/2013,"03/27/2013"
"Drugs",64105,"Ongoing","West-ward Pharmaceutical Corp.","Eatontown","NJ","US","Voluntary: Firm Initiated","Letter","GA","D-189-2013","Class II","a)60 tablets NDC 61748-014-06, b)90 tablets, NDC 61748-014-09, c)100 tablets, NDC 61748-014-01, d)1000 tablets, NDC 61748-014-10, e) blister pack (10s) 61748-014-11","69877A; 68977B; 68978B; 6978C;68979A - exp JUL 2015 68977C; 68978A exp JUL 2013",,"18,825 bottles ","Discoloration: Ethambutol Tablets USP 400 mg have tablets cores that may be discolored.",11/30/2012,"11/30/2012",3/13/2013,"03/13/2013"
"Drugs",64106,"Ongoing","West-ward Pharmaceutical Corp.","Eatontown","NJ","US","Voluntary: Firm Initiated","Letter","GA","D-174-2013","Class II","Isoniazid Tablets 300 mg tablets USP, Rx Only, a) 30 tablets - NDC 61748-013-30, b) 100 tablets - NDC 61748-013-01, Mfd for: VersaPharm Incorporated Marietta, GA 30065-1505, Mfd by: West - Ward Pharmaceutical Corp.., Eatontown, NJ 07724","67079A; 67079B; 67079C",,"77531 bottles","Failed Dissolution Specifications; 36 month stability timepoint",12/4/2012,"12/04/2012",3/6/2013,"03/06/2013"
"Drugs",64107,"Ongoing","West-ward Pharmaceutical Corp.","Eatontown","NJ","US","Voluntary: Firm Initiated","Letter","Nationwide","D-170-2013","Class II","Belladonna Alkaloids (hyoscyamine sulfate, USP 0.1037 mg; atropine sulfate, USP 0.0194 mg; scopolamine HBr, USP 0.0065 mg) with Phenobarbital (USP 16.2 mg) Tablets, packaged in a) 1000-count tablets per bottle (NDC 0143-1140-10; b) 5000-count tablets per bottle (NDC 143-1140-51); Rx only, Manufactured by: West-ward Pharmaceutical Corp. Eatontown, NJ 07724","Lot #: 69099A, 69099B, Exp 08/15",,"6,511 bottles","Presence of Foreign Substance: Uncharacteristic blacks spots were found in tablets.",1/7/2013,"01/07/2013",3/6/2013,"03/06/2013"
"Drugs",64108,"Ongoing","West-ward Pharmaceutical Corp.","Eatontown","NJ","US","Voluntary: Firm Initiated","Letter","OH","D-164-2013","Class III","Glycopyrrolate Tablets, USP, 1 mg, Rx Only, 100 tablets per bottle, Manufactured by: West-ward Pharmaceutical Corp., Eatontown, NJ, 07724, NDC 0143-1250-01. ","Lot #: 69001A",,"1,185 Bottles","Subpotent Drug: Test results for assay were confirmed Out Of Specification (OOS) at 92.8% (specification of 97.0 - 103.0%).",1/7/2013,"01/07/2013",2/20/2013,"02/20/2013"
"Drugs",64109,"Ongoing","Belmora LLC","Arlington","VA","US","Voluntary: Firm Initiated","Letter","Nationwide","D-136-2013","Class III","Flanax (aluminum hydroxide, magnesium hydroxide, and simethicone) Fast Acting Antacid, 200 mg/200 mg/20 mg, 12 fl oz (355 mL) bottles, Distributed by: Belmora LLC, PO Box 3063, Arlington, VA 22203, UPC 8 53030 00209 0, NDC 27854.101.01.","Lot #: 1321, 1322, 1323, and 1324",".","17,996 bottles","Defective Container: Product lacks tamper evident breakaway band on cap.",12/18/2012,"12/18/2012",1/30/2013,"01/30/2013"
"Devices",64110,"Ongoing","CHENICA INC.","Vassar","MI","US","Voluntary: Firm Initiated","Letter","Nationwide Distribution-including the states of Florida, Michigan, South Carolina, California, Texas, Maryland, New York, Tennessee, Virginia, Illinois, Ohio, Massachusetts, Arizona and Washington.","Z-0809-2013","Class II","Chenica Gunnell Rehab Series of Wheelchairs (GRSW); Mechanical Wheelchair, Sold as Rehab Tough and Tilt (TNT), Rehab Recline and Mobility (RAM), Rehab Kidster (Kidster). Provide mobility to individuals limited to a seating position.","Serial Numbers: 36977-1210, 37194-0312, 37455-1111, 37606-0312, 36988-1210, 37220-0511, 37484-1111, 37614-0312, 36999-1210, 37234-0511, 37495-1211, 37628-0312, 37000-1210, 37273-0611, 37497-0711, 37632-0312, 37003-1210, 37305-0711, 37515-1211, 37633-0312, 37014-1210, 37307-0711, 37520-1211, 37636-0312, 37061-0211, 37333-0711, 37521-1211, 37637-0411, 37067-0111, 37348-0811, 37523-1211, 37675-0412, 37094-0211, 37374-0911, 37537-0112, 37681-0412, 37114-0211, 37393-0911, 37555-0112, 37286-0511, 37122-0211, 37394-0911, 37576-0212, 37296-0611, 37137-0311, 37440-1011, 37584-0212, 37141-0311, 37448-1011, 37594-0212, 37185-0311, 37449-1011, 37601-0312.",,"53","The wheelchairs may not meet the specifications of WC-19 (crash testing), therefore the WC-19 verbiage and corresponding logo are removed from the flyers on the Gunnell Rehab Series of Wheelchairs (GRSW). ",1/18/2013,"01/18/2013",2/20/2013,"02/20/2013"
"Devices",64111,"Ongoing","Viterion TeleHealthcare Llc","Tarrytown","NY","US","Voluntary: Firm Initiated","Telephone","Worldwide Distribution-USA (nationwide) and the United Kingdom.","Z-0822-2013","Class II","Viterion TeleHealth Monitor Model Number V500; Product Codes 08832984 (US) and 02080468 (UK) --- Common Name: Telehealth monitor, Classification Name: Monitor, physiological, patient (without arrhythmia detection or alarms) --- Manufactured in Japan for: Viterion TeleHealthcare LLC Tarrytown, New York USA. Viterion V100, V100-BGM and V500 Telehealth Monitors transfer medical information.","All units are affected. Serial Numbers A3303HA000201, A3303HA000202, A3303HA000203, A3303HA000204, A3303HA000205, A3304HA000206, A3304HA000207, A3304HA000208, A3304HA000209, A3304HA000210, A3305HA000211, A3305HA000212, A3305HA000213, A3305HA000214, A3305HA000215, A3306HA000216, A3306HA000217, A3306HA000218, A3306HA000219, A3306HA000220, A3310HA000221, A3310HA000222, A3310HA000223, A3310HA000224, A3310HA000225, A3404HA000226, A3404HA000227, A3404HA000228, A3404HA000229, A3404HA000230, A3404HA000231, A3404HA000232, A3404HA000233, A3404HA000234, A3404HA000235, A3404HA000236, A3404HA000237, A3404HA000238, A3404HA000239, A3404HA000240, A3404HA000241, A3404HA000242, A3404HA000243, A3404HA000244, A3404HA000245, A3404HA000246, A3404HA000247, A3404HA000248, A3404HA000249, A3404HA000250, A3602HA000252, A3602HA000253, A3602HA000254, A3602HA000255, A3602HA000256, A3602HA000257, A3602HA000258, A3602HA000259, A3602HA000260, A3602HA000261, A3602HA000262, A3602HA000263, A3602HA000264, A3602HA000265, A3602HA000266, A3701HA000267, A3701HA000268, A3701HA000269, A3701HA000270, A3701HA000271, A3701HA000272, A3701HA000273, A3701HA000274, A3701HA000275, A3701HA000276, A3701HA000277, A3701HA000278, A3701HA000279, A3701HA000280, A3701HA000281, A3701HA000282, A3701HA000283, A3701HA000284, A3701HA000285, A3701HA000286, A3701HA000287, A3701HA000288, A3701HA000289, A3701HA000290, A3701HA000291, A3818HA000292, A3818HA000293, A3818HA000294, A3818HA000295, A3818HA000296, A3818HA000297, A3818HA000298, A3818HA000299, A3818HA000300, A3818HA000301, A3818HA000302, A3818HA000303, A3818HA000304, A3818HA000305, A3818HA000306, A3818HA000307, A3818HA000308, A3818HA000309, A3818HA000310, A3818HA000311, A3818HA000312, A3818HA000313, A3818HA000314, A3818HA000315, A3818HA000316, A3905HA000317, A3905HA000318, A3905HA000319, A3905HA000320, A3905HA000321, A3905HA000322, A3905HA000323, A3905HA000324, A3905HA000325, A3905HA000326, A3905HA000327, A3905HA000328, A3905HA000329, A3905HA000330, A3905HA000331, A3905HA000332, A3905HA000333, A3905HA000334, A3905HA0003",,"Domestic - 296 units, Foreign - 73 units","The company received complaints reporting that ''HI'' readings on certain blood glucose meters were not transmitting from the patient end through Viterion V100 telehealth monitors to healthcare professionals on the other end, who monitor the patient. A ''HI'' reading indicates that the blood glucose result obtained was beyond the measurable range of the meter. Subsequent investigation confirmed that the Viterion V100, V100-BGM and V500 telehealth monitors do not transmit both ''HI'' (above the meter's measurable range) and ''LO'' (below the meter's measurable range) blood glucose readings from Bayer's Contour Elite XL blood glucose meters, as well as from Roche's Accu-Chek Advantage 03 and 04 meters.",11/15/2012,"11/15/2012",2/20/2013,"02/20/2013"
"Devices",64111,"Ongoing","Viterion TeleHealthcare Llc","Tarrytown","NY","US","Voluntary: Firm Initiated","Telephone","Worldwide Distribution-USA (nationwide) and the United Kingdom.","Z-0821-2013","Class II","Viterion TeleHealth Monitor Model Number V100-BGM, Product Code 81842478 (US) -- Common Name: Telehealth monitor, Classification Name: Monitor, physiological, patient (without arrhythmia detection or alarms) --- Manufactured in Japan for: Bayer HealthCare LLC Tarrytown, New York USA. Viterion V100, V100-BGM and V500 Telehealth Monitors transfer medical information.","All units are affected. List of affected serial numbers were provided as Excel spreadsheet due to the large volume.",,"Domestic - 7698 units","The company received complaints reporting that ''HI'' readings on certain blood glucose meters were not transmitting from the patient end through Viterion V100 telehealth monitors to healthcare professionals on the other end, who monitor the patient. A ''HI'' reading indicates that the blood glucose result obtained was beyond the measurable range of the meter. Subsequent investigation confirmed that the Viterion V100, V100-BGM and V500 telehealth monitors do not transmit both ''HI'' (above the meter's measurable range) and ''LO'' (below the meter's measurable range) blood glucose readings from Bayer's Contour Elite XL blood glucose meters, as well as from Roche's Accu-Chek Advantage 03 and 04 meters.",11/15/2012,"11/15/2012",2/20/2013,"02/20/2013"
"Devices",64111,"Ongoing","Viterion TeleHealthcare Llc","Tarrytown","NY","US","Voluntary: Firm Initiated","Telephone","Worldwide Distribution-USA (nationwide) and the United Kingdom.","Z-0820-2013","Class II","Viterion TeleHealth Monitor Model Number V100, Product Codes 09377512 (US) and 04480218 (UK). Physiological patient monitor (without arrhythmia detection or alarms). Viterion V100, V100-BGM and V500 Telehealth Monitors transfer medical information.","All units are affected. List of affected serial numbers were provided as Excel spreadsheet due to the large volume.",,"Domestic: 19,106 units; Foreign: 267 units","Viterion telehealth monitors do not transmit ''HI'' (above the meter's measurable range) and ''LO'' (below the meter's measurable range) blood glucose readings from Bayer's Contour Elite XL blood glucose meters, or from Roche's Accu-Chek Advantage 03 and 04 meters to healthcare professionals.",11/15/2012,"11/15/2012",2/20/2013,"02/20/2013"
"Devices",64112,"Ongoing","Mindray DS USA, Inc. d.b.a. Mindray North America","Mahwah","NJ","US","Voluntary: Firm Initiated","Letter","Distributed in the states of NC and TX.","Z-0977-2013","Class II","BS-200 Chemistry Analyzer Designed for clinical laboratory use.","Part number BA20E-PA00003; Serial Numbers: WN-28103978F, WN-28103976F, and WN-28103977F.",,"3 units","An issue has been identified with the BS-200 where clinical chemistry results may be inaccurate.",11/28/2012,"11/28/2012",4/3/2013,"04/03/2013"
"Devices",64114,"Ongoing","Mindray DS USA, Inc. d.b.a. Mindray North America","Mahwah","NJ","US","Voluntary: Firm Initiated","Letter","Nationwide Distribution.","Z-0798-2013","Class II","Mindray DS USA, Inc., DPM Central Monitoring System with ambulatory Telepack. Part numbers: 300BF-PA00002, and 300BF-PA00003 (DPM Central Monitoring System) 115-006908-01, -03, -04 (DPM software upgrade kit). The DPM Central Monitoring System transfers information between DPM Central station and other networked devices.","''Part No Serial No300BF-PA00002 EH-17000037 300BF-PA00002 EH-17000032 300BF-PA00002 EH-17000033 300BF-PA00002 EH-25000099 300BF-PA00002 EH-18000043 300BF-PA00003 EH-1A000072 300BF-PA00002 EH-22000088 300BF-PA00003 EH-1A000073 300BF-PA00002 EH-12000060 300BF-PA00002 EH-17000038 300BF-PA00003 EH-21000077 300BF-PA00002 EH-18000058 300BF-PA00002 EH-23000096 300BF-PA00003 EH-19000059 300BF-PA00003 EH-19000060 300BF-PA00002 EH-18000051 300BF-PA00002 EH-12000054 300BF-PA00002 EH-16000029 300BF-PA00002 EH-11000052 300BF-PA00002 EH-17000039 300BF-PA00003 EH-1A000064 300BF-PA00002 EH-18000050 300BF-PA00003 EH-13000078 300BF-PA00003 EH-13000085 300BF-PA00002 EH-18000053 300BF-PA00002 EH-17000036 300BF-PA00002 EH-17000031 300BF-PA00003 EH-17000040 300BF-PA00002 EH-18000054 300BF-PA00002 EH-1A000069 300BF-PA00002 EH-12000062 300BF-PA00002 EH-21000076 115-006908-04 Software Kit 300BF-PA00003 EH-13000083 300BF-PA00003 EH-13000084 300BF-PA00003 EH-22000087 300BF-PA00002 EH-18000056 300BF-PA00002 EH-17000035 300BF-PA00002 EH-18000048 300BF-PA00002 EH-18000052 300BF-PA00003 EH-21000081 300BF-PA00002 EH-17000030 115-006908-03 Software Kit 115-006908-03 Software Kit 115-006908-03 Software Kit 300BF-PA00003 EH-19000062 300BF-PA00002 EH-18000057 300BF-PA00003 EH-22000083 300BF-PA00002 EH-11000051 300BF-PA00002 EH-18000041 300BF-PA00002 EH-21000082. ''",,"51 units","Mindray has identified a software anomaly that may where, in the presence of an asystole, the Telepack ECG waveform may produce a unique step pattern (instead of a flat line) if Lead 1 or V is being utilized for detecting cardiac arrhythmia.",11/28/2012,"11/28/2012",2/20/2013,"02/20/2013"
"Devices",64115,"Ongoing","Diagnostic Hybrids Inc","Athens","OH","US","Voluntary: Firm Initiated","Letter","Nationwide Distribution including the states of AR, AZ, CA, CO, CT, FL, GA, HI, IA, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, NC, NE, NJ, NM, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, VA, WA & WI.","Z-0792-2013","Class III","Diagnostic Hybrids, Inc., RhMK, Model #:49-0600, 49-0600A, 49-0102A, and 49-T075A. Culture media, used in the cultivation and amplification of viruses, such as respiratory viruses, enteroviruses, measles, and poliovirus from patient specimens.","Model #:49-0600, Lot#, 491206T, 491216; Model #: 49-0600A, Lot#, -A-491206T, -A-491216, -A-491216B; Model #: 49-0102A, Lot#, -A-491206T, -A-491216 & Model #: 49-T075A, Lot#, -A-491206T, -A-491216.",,"13,005 units","Fungal contamination.",12/31/2012,"12/31/2012",2/13/2013,"02/13/2013"
"Drugs",64116,"Ongoing","Ascend Therapeutics Inc","Herndon","VA","US","Voluntary: Firm Initiated","Letter","Products were distributed nationwide.","D-146-2013","Class III","EstroGel (estradiol gel) 0.06%, contained in 50-gr metered pumps, 1.25g/pump depression, for use as physician starter samples; product is labeled in part ***Manufactured for ASCEND Therapeutics Herndon, VA 20170 by DPT Laboratories San Antonio TX 78215***","Lot Number: EHAD Exp. 07/14",,"4, 835 bottles","Defective Container: Pump head detaching from the canister unit upon removal of the overcap.",11/19/2012,"11/19/2012",2/13/2013,"02/13/2013"
"Devices",64117,"Ongoing","Hamilton Medical Inc","Reno","NV","US","Voluntary: Firm Initiated","Letter","US Nationwide Distribution including the country of Switzerland.","Z-0741-2013","Class I","HAMILTON-T1 Ventilator with software versions 1.1.2 or lower. The HAMILTON T-1 Ventilator is intended to provide positive pressure ventilatory support to adults and pediatrics","Software Versions 1.1.2 and below; Part numbers 161005, 161006.",".","97 total ventilators; 69 of part number 161005 and 28 of part number 161006","Analysis of a customer complaint has shown that during ventilation of small pediatric patients with high airway resistance and low lung compliance, the oxygen consumption of a Hamilton T1 ventilator with software versions 1.1.2 and lower must be calculated using a larger margin than originally expected.",1/11/2013,"01/11/2013",2/6/2013,"02/06/2013"
"Drugs",64118,"Ongoing","Sandoz Incorporated","Broomfield","CO","US","Voluntary: Firm Initiated","Letter","Nationwide","D-152-2013","Class III","Syeda (drospirenone and ethinyl estradiol), 3 mg/0.03 mg, 3 x 28 tablet blistercards, combination oral contraceptive tablet, Manufactured by Laboratorios Leon Farma S.A., Spain for Sandoz Inc., Princeton, NJ","LF01215A, Exp 02/2014",,"17,188 cartons containing 3 cards each.","Tablet/Capsule Imprinted with Wrong ID; a portion of the tablets could contain the incorrect debossing on one side of the tablet U2 instead of U3.",1/22/2013,"01/22/2013",2/13/2013,"02/13/2013"
"Biologics",64119,"Terminated","Blood Systems, Inc. dba United Blood Services","Lubbock","TX","US","Voluntary: Firm Initiated","Telephone","Texas","B-0409-13","Class III","Red Blood Cells Leukocytes Reduced","W041512052481*; ",".","1","Blood product, collected from a donor whose medical history screening was not adequately performed, was distributed. ",12/7/2012,"12/07/2012",5/15/2013,"05/15/2013"
"Biologics",64120,"Terminated","Blood Centers of the Pacific - Irwin Center","San Francisco","CA","US","Voluntary: Firm Initiated","Telephone","California","B-0988-13","Class II","Red Blood Cells Leukocytes Reduced","W1170125196435; ",,"1","Blood product, which was collected from a donor who traveled to a malarial endemic area, was distributed",12/14/2012,"12/14/2012",5/8/2013,"05/08/2013"
"Biologics",64121,"Terminated","Blood Centers of the Pacific - Irwin Center","San Francisco","CA","US","Voluntary: Firm Initiated","Telephone","California","B-0989-13","Class III","Red Blood Cells Deglycerolized Leukocytes Reduced","W117008129536J Part 1; W117008129536J Part 2; ",,"2","Blood products, with an unacceptably low red cell recovery rate, were distributed.",12/3/2012,"12/03/2012",5/8/2013,"05/08/2013"
"Biologics",64122,"Terminated","Beth Israel Medical Center, The Ralph Gore Blood Bank","New York","NY","US","Voluntary: Firm Initiated","Telephone","New York","B-0990-13","Class II","Red Blood Cells Irradiated","W139312000229; ",,"1","Blood product, labeled as leukoreduced, but which had not undergone leukoreduction, was distributed.",12/28/2012,"12/28/2012",5/8/2013,"05/08/2013"
"Biologics",64123,"Terminated","Florida's Blood Centers, Inc.","Orlando","FL","US","Voluntary: Firm Initiated","Letter","Florida","B-0991-13","Class II","Red Blood Cells Leukocytes Reduced","W038112245276; ",,"1","Blood product, collected from a donor who traveled to an area considered endemic for malaria, was distributed.",12/10/2012,"12/10/2012",5/8/2013,"05/08/2013"
"Biologics",64124,"Terminated","Florida's Blood Centers, Inc.","Orlando","FL","US","Voluntary: Firm Initiated","Letter","Florida","B-0992-13","Class II","Red Blood Cells Leukocytes Reduced","W038112265889; ",,"1","Blood products, collected from donors, whose suitability to donate was not adequately determined, were distributed.",11/14/2012,"11/14/2012",5/8/2013,"05/08/2013"
"Biologics",64125,"Terminated","Florida's Blood Centers, Inc.","Orlando","FL","US","Voluntary: Firm Initiated","Letter","Florida","B-0993-13","Class II","Red Blood Cells Leukocytes Reduced","W038112261399; ",,"1","Blood product, collected from a donor who traveled to an area considered endemic for malaria, was distributed.",11/20/2012,"11/20/2012",5/8/2013,"05/08/2013"
"Biologics",64126,"Terminated","American National Red Cross","Cleveland","OH","US","Voluntary: Firm Initiated","Other","California","B-0994-13","Class III","Blood and Blood Products for Reprocessing","42FR80763; 42S64749; ",,"2","Blood products, collected from a donor in whom donor suitability was not adequately determined, were distributed.",12/5/2012,"12/05/2012",5/8/2013,"05/08/2013"
"Devices",64127,"Ongoing","Philips Healthcare Inc.","Andover","MA","US","Voluntary: Firm Initiated","Letter","US Nationwide Distribution including the states of FL, CA, WA, AZ, NC, KY, DE, AZ and MO.","Z-0767-2013","Class II","Phillips Easy Diagnost Eleva DRF. Model Number: 706034 Product Usage: Universal Fluoroscopic Applications ","Serial Numbers 362600, 362601, 364209, 364210, 375245, 375850, 376439, 384396, 387492, 398185, 399440, 399621, 399623, 402409",,"14 units","The mirror icon on the bottom of each image could be misinterpreted as a RIGHT lead marker for side indication if the image is mirrored within a PACS system. ",1/16/2013,"01/16/2013",2/13/2013,"02/13/2013"
"Devices",64128,"Ongoing","Philips Healthcare Inc.","Andover","MA","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution - US Nationwide and the country of Canada.","Z-1450-2013","Class II","Philips BuckyDiagnost Radiographic. Catalog Numbers: 704031, 704032, 704035, 704060, 704062 This system is used for making x-ray exposures for diagnostics","Serial Numbers: 334584 345869 349805 352617 375957/SN07000650 352645 355617 356954 363678 362217 362252 361021 364214 362429 361526 363545 363802 364816 366510 366090 367504 370290 370643 373506 372845 376998 383090 384688/SN07000603 386397/SN07000659 406161/SN08000556 386265/SN08000415 389969/SN08000090 381103/SN08000131 444254/SN09000380 406491/SN08000315 389383/SN08000100 447038/SN10000169 389970/SN08000092 406017/SN08000307 389972/SN08000080 389656/SN08000052 386679/SN08000051 390255/SN08000050 394368/SN08000196 396406/SN08000193 399529/SN08000297 401268/SN08000268 402249/SN08000323 399571/SN08000559 384510/SN07000618 402246/SN08000261 403330/SN08000296 403648/SN08000292 407890/SN08000377 405887/SN08000381 413307/SN08000521 413205/SN08000562 411311/SN08000528 419318/SN09000042 428504/SN09000200 413818/SN08000526 414461/SN08000518 414601/SN08000501 438511/SN10000166 414315/SN08000474 418205/SN08000568 419316/SN09000007 421970/SN09000058 422097/SN09000068 426137/SN09000109 430918/SN09000175 435194/SN09000234 439546/SN09000334 439739/SN09000346 436337/SN09000251 438835/SN09000295 439098/SN09000294 439817/SN09000318 443072/SN09000363 443231/SN09000368 442855/SN09000357 443453/SN09000378 456506/SN10000167 449719/SN10000034 448152/SN10000013 448150/SN10000072 449717/SN10000068 450554/SN10000096 451156/SN10000059 456283/SN10000272 456082/SN10000174 458580/SN10000196 459495/SN10000212 460074/SN10000260 460485/SN10000228 460757/SN10000290 461677/SN10000302 461229/SN10000218 462389/SN10000252 463385/SN10000344 465974/SN10000320 468064/SN10000347 466164/SN10000336 468078/SN11000032 468518/SN10000353 470291/SN10000374 471046/SN10000386 471701/SN11000054 483054/SN11000246 476276/SN11000045 480210/SN11000126 483867/SN11000298 483244/SN11000199 486144/SN11000217 488176/SN11000244 ",,"116 units","An inspection of IATD (Installation Acceptance Test Document)IA SID (Source Image Distance) records shows table height measurements out of specification with the consequence of potential system mis-alignment",1/16/2013,"01/16/2013",6/26/2013,"06/26/2013"
"Devices",64128,"Ongoing","Philips Healthcare Inc.","Andover","MA","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution - US Nationwide and the country of Canada.","Z-1449-2013","Class II","Philips BuckyDiagnost Radiographic, a Diagnostic X-ray system. Catalog Numbers: 704031, 704032, 704035, 704060, 704062 This system is used for making x-ray exposures for diagnostics.","Serial Numbers: 335292 351085 351326 348891 348895 353313 358016 359426 370503 354382 354749 369640 380748 356820 362256 357699 362257 357255 358489 380361 363543 362719 363669 363544 363305 363538 365150 364211 379698 380749 375725 375727 375729 377144 381880 381881 380798/SN07000617 381877 383767/SN07000639 392883/SN08000099 394519/SN08000135 421035/SN09000031 396577/SN08000190 402575/SN08000382 397513/SN08000185 407681/SN08000345 411751/SN08000438 410786/SN08000454 417251/SN08000547 427833/SN09000208 415998/SN08000511 416000/SN08000508 421979/SN09000098 422100/SN09000216 442036/SN09000336 448226/SN09000416 455130/SN10000286 462191/SN10000266 468071/SN10000398 467831/SN10000326 471707/SN11000023 477922/SN11000076 481951/SN11000205 489697/SN11000261 ",,"66 units","An inspection shows several IATDs (Installation Acceptance Test could not be located or different templates have been used",1/16/2013,"01/16/2013",6/26/2013,"06/26/2013"
"Devices",64129,"Ongoing","Greatbatch Medical","Minneapolis","MN","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution-USA including the states of CA, IN, KS, MA, NJ, PA, TN, and TX, and the countries of AUSTRALIA, BRAZIL, CANADA, DENMARK, FRANCE, GERMANY, ITALY, JAPAN, PORTUGAL, and SWITZERLAND.","Z-0751-2013","Class II","45 Angle Driver / Z-H, Greatbatch Medical 10 000 Wahrie Drive, Clarance, NY 14031. Model #: P2661, P2662, T3635, T5586,T6031, T6164,T10161, T12628,T14879, T16422,T2487,T2713,T116057, T13635, MPU260045AO01, MPU260045ZH01. The Driver is intended to act as an interface between the cutting tool and a motorized driving system (i.e. surgical drill).","All lots",".","913","Greatbatch Medical has initiated a global voluntary recall and market withdrawal of its entire Small Angled Driver 45 product line. Greatbatch has received reports of noisy and / or rough operation when using these Small Angled Drivers.",1/16/2013,"01/16/2013",2/6/2013,"02/06/2013"
"Devices",64130,"Ongoing","Philips Healthcare Inc.","Andover","MA","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution - USA Nationwide and the country of Canada","Z-1448-2013","Class II","Philips Diagnost Stationary Radiographic System Models: 712020, 712022, 712050, 712052, 712055, 712057, 712062 Product Usage: Universal RAD Applications ","Serial numbers: 316235 335517 321739 334582 359767 357879 344896 351321 356953 365640 365639 359449 363674 375601/SN0802006 368428 7272440 372848 373508 375366 396836/SN0802372 382140/SN0702475 381883/SN0802010 393931/SN0802399 396572/SN0802281 392502/SN0802179 390113/SN0802451 386784/SN0802264 381098/SN0802124 390098/SN0802242 382018/SN0802118 9000529 373499/SN0802249 383639/SN0802099 390129/SN0802521 404296/SN0802460 404298/SN0802474 416255/SN0902004 802119 409788/SN0802635 406492/SN0802489 390393/SN0802337 399024/SN0802562 402837/SN0802410 408716/SN0802551 408239/SN0802583 408240/SN0802630 408236/SN0802554 406024/SN0802481 408591 406156/SN0802537 406140/SN0802479 407675/SN0802517 408967/SN0802547 414087/SN08000100 435757/SN09000361 422092/SN0902023 415783/SN0802662 422536/SN09000199 416904/SN08000052 421962/SN09000054 429129/SN09000365 426287/SN09000096 430908/SN09000165 441638/SN09000356 456404/SN10000212 435210/SN0902204 435924/SN09000281 438069/SN09000278 439920/SN09000329 443660/SN10000010 449005/SN10000094 443235/SN09000450 448008/SN10000043 455848/SN10000351 455621/SN10000163 455622/SN10000164 449232/SN10000248 449364/SN10000078 449365/SN10000110 451680/SN10000202 457265/SN10000417 475767/SN11000387 453200/SN10000133 452170/SN10000401 453201/SN10000124 466031/SN11000053 459498/SN10000231 464880/SN10000714 464350/SN10000589 470908/SN11000183 485692/SN11000443 470803/SN10000667 475846/SN11000269 477673/SN11000278 478112/SN11000163 478232/SN11000216 480052/SN11000286 480053/SN11000288 487808/SN11000526 488714/SN11000572 492704/SN11000641 ",,"101 units","Installation Acceptance Test Document (IATD) non compliant with regulations. Records shows table height measurements out of specification with the consequence of potential system mis-alignment. ",1/16/2013,"01/16/2013",6/26/2013,"06/26/2013"
"Devices",64130,"Ongoing","Philips Healthcare Inc.","Andover","MA","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution - USA Nationwide and the country of Canada","Z-1447-2013","Class II","Philips Diagnost Stationary Radiographic System Models: 712020, 712022, 712050, 712052, 712055, 712057, 712062 Product Usage: Universal RAD Applications ","Serial Numbers: 248244 351896 304009 347726 340184 353318 316236 357275 356983 325939 325940 602603 702009 348997 362251 356153 356131 351083 356334 355648 355646 354256 355644 356526 362438 7212356 359439 357888 355621 370816 357413 367356 358322 363680 358494 7000281 363670 703465 363671 367771 375952 365956 372485 372486 369545 70700 372973 374374 375370 380750/SN0702498 385560/SN0802190 401126/SN0802540 396834/SN0802370 414494/SN0802648 429753/SN0902090 434680/SN0902161 379200/SN0802088 390276/SN0802289 390109/SN0802396 383893/SN0802238 419661/SN0902011 402570/SN0802420 425721/SN0902102 414495/SN0802649 381879/SN0802058 384511/SN0802050 384779/SN0802164 410916/SN0802636 392486/SN0802181 434675/SN1002002 427612/SN0902122 389101/SN0802194 384033/SN0802219 392505/SN0802162 392504/SN0802182 382164/SN0802018 367618 396576/SN0802233 427616/SN0902145 428232/SN0902049 415314/SN0902058 396197/SN0802210 445433/SN09000434 398178/SN0802348 427504/SN0902048 399555/SN0802572 422534/SN0902027 399153/SN0802347 422101/SN0902030 412482/SN0802683 404166/SN0802441 402844/SN0802432 402853/SN0902012 405687/SN0802469 404164/SN0802462 404459/SN0802468 407425/SN08000031 418438/SN08000110 409702/SN0802557 435537/SN0902144 408200/SN0802520 409461 414931/SN0902033 412678/SN0802695 410040/SN08000021 410038/SN08000091 410039/SN08000093 423259/SN09000074 422832/SN09000061 412921/SN0802657 427610/SN0902108 433651/SN0902114 413845/SN09000004 415626/SN08000067 416651/SN08000086 422535/SN09020032 437764/SN09000292 421977/SN09000115 455753/SN10000432 455225/SN11000051 423037/SN09000153 421032/SN09000063 421034/SN09000041 427226/SN09000209 428241/SN09000220 435420/SN09000263 441921/SN09000431 440260/SN09000350 430355/SN09000214 441778/SN09000452 440249/SN09000347 439032/SN09000305 440692/SN09000443 444627/SN10000142 442306/SN10000177 442310/SN10000149 442129/SN10000171 442235/SN10000160 455550/SN10000364 4",,"177 units","Installation Acceptance Test Document (IATD) non compliant with regulations IATDs (Installation Acceptance Test could not be located or different templates have been used",1/16/2013,"01/16/2013",6/26/2013,"06/26/2013"
"Devices",64132,"Ongoing","Hitachi Chemical Diagnostics Inc","Mountain View","CA","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Worldwide Distribution - France only","Z-0793-2013","Class III","OPTIGEN Food 30; Manufactured by Hitachi Chemical Diagnostics, Mountain View, CA. Distributed by Theridiag, Cedex, France Allergen testing","Catalog number: 85035. Lot number 42K283626, expiration May 31, 2013.",,"20 kits","A non conformance was identified with one lot of OPTI GEN Food 30 where there is no evidence that a visual inspection was performed on one tray of coverslips,",12/21/2012,"12/21/2012",2/13/2013,"02/13/2013"
"Devices",64134,"Ongoing","GE Healthcare, LLC","Waukesha","WI","US","Voluntary: Firm Initiated","Letter","Nationwide Distribution","Z-0704-2013","Class II","GE Healthcare Definium 5000/5220493-2 X-Ray System .This expected use for this product is intended to take diagnostic radiographic exposures of the skull, spinal column, chest, extremities, abdomen and other body parts."," Definium Model 5000/5220493-2 ",,"312 installed in US","It was discovered GE Healthcare had become aware of a software issue associated with the user interface of Definium 5000.",9/26/2012,"09/26/2012",3/6/2013,"03/06/2013"
"Devices",64134,"Ongoing","GE Healthcare, LLC","Waukesha","WI","US","Voluntary: Firm Initiated","Letter","Nationwide Distribution","Z-0703-2013","Class II","GE Healthcare Definium 5000 / 5220493 X-Ray System This expected use for this product is intended to take diagnostic radiographic exposures of the skull, spinal column, chest, extremities, abdomen and other body parts.","Definium Model 5000/5220493 ",,"312 installed in US","It was discovered GE Healthcare had become aware of a software issue associated with the user interface of Definium 5000.",9/26/2012,"09/26/2012",3/6/2013,"03/06/2013"
"Devices",64135,"Ongoing","Carestream Health, Inc.","Rochester","NY","US","Voluntary: Firm Initiated","Letter","US Nationwide Distribution including the states of California, Florida, Texas, Illinois, Indiana, Maryland, Pennsylvania and Canada.","Z-0744-2013","Class II","KODAK INSIGHT DENTAL FILM in SureSoft Packets, Size 2 Single Packet Film, Model Number IP21S, REF/Catalog Number 8118226 --- COMMON/USUAL NAME: Dental Intraoral Radiographic Film -- 20 cartons of 80 packets. Product Usage: Dental intraoral radiography ","Lot 2114596 (Exp. September 2014)",".","101 cartons: Domestic - 95 cartons; Foreign - 6 cartons","The company discovered that some cartons of KODAK INSIGHT with SureSoft Packets Dental Film Catalog Number 8118226 have missing symbols and manufacturing information on the clear carton label. The expiration dating symbol is missing but the expiration date is not missing. The Lot symbol is missing but the lot number is not missing. The Manufacturer symbol, name and address including country of origin are missing. All of the remaining symbols and information are on the case label. Missing information is only associated with the clear carton label. ",1/17/2013,"01/17/2013",2/6/2013,"02/06/2013"
"Devices",64135,"Ongoing","Carestream Health, Inc.","Rochester","NY","US","Voluntary: Firm Initiated","Letter","US Nationwide Distribution including the states of California, Florida, Texas, Illinois, Indiana, Maryland, Pennsylvania and Canada.","Z-0744-2013","Class III","KODAK INSIGHT DENTAL FILM in SureSoft Packets, Size 2 Single Packet Film, Model Number IP21S, REF/Catalog Number 8118226 --- COMMON/USUAL NAME: Dental Intraoral Radiographic Film -- 20 cartons of 80 packets. Product Usage: Dental intraoral radiography ","Lot 2114596 (Exp. September 2014)",,"101 cartons: Domestic - 95 cartons; Foreign - 6 cartons","Missing symbols and manufacturing information on the clear carton label. The expiration dating symbol is missing but the expiration date is not missing. The Lot symbol is missing but the lot number is not missing. The Manufacturer symbol, name and address including country of origin are missing. All of the remaining symbols and information are on the case label. Missing information is only associated with the clear carton label. ",1/17/2013,"01/17/2013",2/13/2013,"02/13/2013"
"Devices",64136,"Ongoing","Ad-Tech Medical Instrument Corporation","Racine","WI","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution - USA Nationwide including the states of CA, GA, LA, MA, MD, MI, MN, NH, PA, RI, TX, UT, WI and the countries of: Australia, CANADA, ENGLAND, JAPAN, KOREA, and SWITZERLAND.","Z-0892-2013","Class I","Macro Micro Subdural Electrode Product Usage: The AD-TECH Subdural Electrodes are intended for temporary (<30 days) use with recording, monitoring and stimulation equipment, for the recording, monitoring and stimulation of electrical signals on the surface level of the brain. The recording of electrical activity supports definition of the location of epileptogenic foci and brain mapping. ","REF numbers (catalog numbers): EG10A-SP10N-000, EG34B-SP10X-000, EGD7A-MP12N-000, EGE4A-SP10N-000, EGE4A-SP10X-000, QG10B-SP10X-000, QG10C-SP10N-000, QG10D-SP10N-000, QG11A-SP10X-000, QG16A-SP10X-000, QG17A-SP10X-000, QG18A-SP10N-000, QG18A-SP10X-000, QG20B-SP10N-000, QG20B-SP10X-000, QG20C-SP10N-000, QG20C-SP10X-000, QG20D-SP10X-200, QG20E-SP10X-000, QG20F-SP10X-000, QG24A-SP10N-000, QG26A-SP10N-000, QG32A-SP10X-000, QG32B-SP10X-000, QG36A-SP10N-000, QG36A-SP10X-000, QG36B-SP10N-000, QG44A-SP10X-000, QG53A-SP10X-000, QG66A-SP85N-000, QG69A-SP10N-000, QG88A-SP10X-000, QG96A-SP10N-000, QG96A-SP10X-000, QG96C-SP10X-000, QG96D-SP10X-000, QGC6A-SP07N-000, QGC8A-SP10N-000, QGC8A-SP10X-000, QGC8B-SP10X-000, QGC8C-SP10X-000, QGC8D-SP10N-000, QGC8E-SP10X-000, QGC8F-SP10X-000, QS20A-SP10N-000, QS40B-SP10X-000, Lot numbers: 208140314, 208140343, 208140344, 208140353, 208140354, 208140362, 208140369, 208140374, 208140381, 208140382, 208140387, 208140390, 208140395, 208140398, 208140399, 208140414, 208140417, 208140421, 208140431, 208140443, 208140445, 208140450, 208140452, 208140453, 208140458, 019020, 208140356R, 208140357R, 208140452R, C010180001, C702201001, C703160006, C704040001, C800250002, C800350004, C801240003, C802220003, C802220005, C802220006, C805210003, C805210004, C908221002, G012111001, G012140002, G015020002, G016240001, G017250004, G017250005, G017250006, G018011001, G018011002, G018011003, G019021002, G019021003, G019150003, G112270004, G114160001, G114160002, G115080002, G115170004, G115280005, G119020004, G211220001, G608060002, G704150001, G805270001, G900211002, G903011001, G903080003, S903080004, S905280003.",,"115","The microelectrodes are not flush with the silastic substrate, may contain sharp edges capable of abrading the cortical surface, and may have remaining pieces which may fracture and remain in the cortical tissue with the electrode is explanted.",12/18/2012,"12/18/2012",3/13/2013,"03/13/2013"
"Drugs",64137,"Ongoing","Procter & Gamble Hair Care Llc","Iowa City","IA","US","Voluntary: Firm Initiated","Letter","Nationwide","D-167-2013","Class III","Crest PRO-HEALTH CPC Antigingivitis/Antiplaque Oral Rinse, 250 mL (8.4 fl oz),Dist. by Procter & Gamble, Cincinnati, OH 45202 NDC 37000-452-02","22155395UA Expires: 07/2014",".","71,040 bottles","Cross Contamination with Other Products: Product was mixed with another type of mouth wash. ",1/23/2013,"01/23/2013",2/27/2013,"02/27/2013"
"Food",64138,"Ongoing","Knotts Wholesale Foods Inc","Paris","TN","US","Voluntary: Firm Initiated","Telephone","TN, KY","F-0961-2013","Class I","Knott's FINE FOODS, CHICKEN SALAD (sandwich), KNOTT's WHOLESALE FOODS, INC. 125 North Blakemore, Paris, TENNESSEE 38242, (731) 642-1961 www.knotsfoods.com, UPC 011984011326","all date codes up to and including 01/29",".","461 units","Sample collected by State of Tennessee Department of Agriculture was found to contain Listeria Monocytogenes",1/20/2013,"01/20/2013",2/6/2013,"02/06/2013"
"Cosmetics",64139,"Ongoing","Procter & Gamble Hair Care Llc","Iowa City","IA","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Distribution was made to AR, AZ, AK, CA, CO, IA, IL, IN, KS, MI, MO, MN, NC, NE, NV, OR, TX, UT and WI.","F-1021-2013","Class III","Scope Mouthwash, original mint, 1.5 L or 50.7 fl oz., distributed by Procter & Gamble, Cincinnati, OH.","Manufacturing Code: 22195395ZB",,"5988/6/1.5-L bottle/cases","Recalled products may have mixed during manufacturing process and products may appear cloudy and have sediment.",1/23/2013,"01/23/2013",3/6/2013,"03/06/2013"
"Cosmetics",64139,"Ongoing","Procter & Gamble Hair Care Llc","Iowa City","IA","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Distribution was made to AR, AZ, AK, CA, CO, IA, IL, IN, KS, MI, MO, MN, NC, NE, NV, OR, TX, UT and WI.","F-1020-2013","Class III","3D White Arctic Fresh, 32 fl oz or 946 mL, whitening oral rinse, contains alcohol, distributed by Procter & Gamble, Cincinnati, OH.","Manufacturing Code: 22155395RF",,,"Recalled products may have mixed during manufacturing process and products may appear cloudy and have sediment.",1/23/2013,"01/23/2013",3/6/2013,"03/06/2013"
"Biologics",64140,"Terminated","Bergen Comm Reg Blood Center","Paramus","NJ","US","Voluntary: Firm Initiated","Telephone","New Jersey","B-1050-13","Class III","Fresh Frozen Plasma","W065612041135; ",".","1 unit","Blood product, which was collected from a donor in which donor suitability was not adequately determined, was distributed.",12/19/2012,"12/19/2012",4/24/2013,"04/24/2013"
"Biologics",64141,"Terminated","American National Red Cross (the)","Charlotte","NC","US","Voluntary: Firm Initiated","Letter","South Carolina; California","B-1003-13","Class II","Red Blood Cells Leukocytes Reduced","012GE28907; ",".","1 unit","Blood products, collected from a donor for whom donor suitability was not adequately determined, were distributed.",12/3/2012,"12/03/2012",4/24/2013,"04/24/2013"
"Biologics",64141,"Terminated","American National Red Cross (the)","Charlotte","NC","US","Voluntary: Firm Initiated","Letter","South Carolina; California","B-1004-13","Class III","Blood and Blood Products for Reprocessing","012GE28907; 012GH80270; ",".","2 units","Blood products, collected from a donor for whom donor suitability was not adequately determined, were distributed.",12/3/2012,"12/03/2012",4/24/2013,"04/24/2013"
"Biologics",64142,"Terminated","Meek Blood Center","Abilene","TX","US","Voluntary: Firm Initiated","FAX","Texas","B-1009-13","Class III","Red Blood Cells Leukocytes Reduced","W141412018769; ",".","1 unit","Blood product, collected from a donor whose suitability to donate was not adequately determined, was distributed.",9/21/2012,"09/21/2012",4/24/2013,"04/24/2013"
"Biologics",64143,"Terminated","Coffee Memorial Blood Center","Amarillo","TX","US","Voluntary: Firm Initiated","FAX","Tennessee; Korea, Republic Of(South)","B-1018-13","Class II","Red Blood Cells Leukocytes Reduced","W067312012405; ",".","1 unit","Blood product, collected from a donor who received a tattoo within 12 months of donation, were distributed.",11/21/2012,"11/21/2012",4/24/2013,"04/24/2013"
"Biologics",64144,"Terminated","Community Blood Center Of Gtr KC","Kansas City","MO","US","Voluntary: Firm Initiated","FAX","Missouri","B-1028-13","Class II","Red Blood Cells Leukocytes Reduced","W045011091969; ",".","1 unit","Blood product, which was collected from a donor who traveled to malarial endemic areas, was distributed. ",12/6/2012,"12/06/2012",4/24/2013,"04/24/2013"
"Food",64145,"Ongoing","Pascalite, Incorporated","Worland","WY","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Nationally (U.S.); Canada, UK, Hong Kong, and Australia.","F-1127-2013","Class II","Pascalite Powder 8 oz, 16 oz, 5 lb, and 25 lb packaged in semitransparent flexible plastic containers with a stick on label. Pascalite Clay Powder, Pascalite Inc, PO Box 104 Worland, WY 82401, 307-347-3872 with directions for use as a Poultice, skin cleanser and softener, deodorant an freshener, dentrifice and oral hygiene, and dietary supplement for adults and children over 6.","Lot numbers imprinted or hand written include: 2010M; and D10 through 12 with a noted OT,U,V, or W. The code information is found on the bottom of the product.",".","In part of 2,655 units.","Pascalite is recalling internally used pascalite powder products because they may contain violative levels of lead.",1/2/2013,"01/02/2013",3/27/2013,"03/27/2013"
"Cosmetics",64145,"Ongoing","Pascalite, Incorporated","Worland","WY","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Nationally (U.S.); Canada, UK, Hong Kong, and Australia.","F-1128-2013","Class II","Pascalite tooth powder, contained in a semitransparent flexible 6 oz. bottle with a flip top for dispensing.","Lot numbers imprinted or hand written include: 2010M; and D10 through 12 with a noted OT,U,V, or W. The code information is found on the bottom of the product.",".","Included in part of a total of 2,655 units.","Pascalite is recalling internally used pascalite powder products because they may contain violative levels of lead.",1/2/2013,"01/02/2013",3/27/2013,"03/27/2013"
"Food",64145,"Ongoing","Pascalite, Incorporated","Worland","WY","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Nationally (U.S.); Canada, UK, Hong Kong, and Australia.","F-1126-2013","Class II","Pascalite Capsules 100 count white plastic bottle with a screw on top, Pascalite Inc, PO Box 104 Worland, WY 82401 307-347-3872, Dietary Supplement for adults and children over 12 years two capsules daily, each vegi cap (size 00) contains approx. 1/4 tsp pascalite powder.","Lot numbers imprinted or hand written include: 2010M; and D10 through 12 with a noted OT,U,V, or W. The code information is found on the bottom of the product.",".","In part of 2,655 Units","Pascalite is recalling internally used pascalite powder products because they may contain violative levels of lead.",1/2/2013,"01/02/2013",3/27/2013,"03/27/2013"
"Devices",64146,"Ongoing","B Braun Medical, Inc.","Carrollton","TX","US","Voluntary: Firm Initiated","Letter","Nationwide Distribution.","Z-2164-2013","Class II","Outlook ES pump is intended for use with B. Braun Medical Inc. Horizon Pump IV Sets. Used to regulate the flow of primary and secondary fluids when positive pressure is required. The infusion system is capable of delivering fluid from a negative head height (when the IV fluid container is lower than the pump), and provides clinically accepted volumetric accuracy for all standard IV fluids, including blood, lipid, and Total Parenteral Nutrition (TPN). Model number: 621-100ES, 621-200ES, 621-300ES, and 621-400ES. To deliver a broad range of drugs with use with the B. Braun Medical Inc. Horizon Pump IV Sets.","Model number: 621-100ES, 621-200ES, 621-300ES, and 621-400ES with main processor software versions prior to 151580. Multiple serial numbers affected. Affected serial numbers were notified of this field correction. ",".","1,970 pumps added for this expansion","This notice is being provided in follow up to the field correction initiated by B. Braun Medical Inc. on 26 August, 2011 due to an issue in the Outlook ES Safety Infusion System where the Care Area can inadvertently be exited thereby removing DoseGuard dose limit protection. This occurs when a sequence of HOLD - HOLD key strokes are performed on the pump key panel while the user is in the Dose Data Entry screen, or in specific circumstances when the HOLD key is used to silence the KYO alarm at the end of a DOSE Mode infusion. The issue can potentially be observed in Outlook ES pump models 100ES, 200ES, 300ES and 400ES with management processor software versions prior to 151580. It is possible that an under or overdose situation could occur because the user can inadvertently remove previously programmed dose limit values for the selected drug and user notification will not be generated if these dose values are exceeded. B. Braun Medical Inc. has identified that not all of the affected Outlook ES pumps were listed in the original notification of this field correction. Although these pumps were not identified in the previous notice, these pumps were upgraded, if available, during a routine field service. This follow up notification is to ensure that all pumps have been identified.",10/31/2012,"10/31/2012",9/18/2013,"09/18/2013"
"Devices",64147,"Ongoing","B Braun Medical, Inc.","Carrollton","TX","US","Voluntary: Firm Initiated","Letter","Nationwide Distribution.","Z-2163-2013","Class II","Outlook ES pump is intended for use with B. Braun Medical Inc. Horizon Pump IV Sets. Used to regulate the flow of primary and secondary fluids when positive pressure is required. The infusion system is capable of delivering fluid from a negative head height (when the IV fluid container is lower than the pump), and provides clinically accepted volumetric accuracy for all standard IV fluids, including blood, lipid, and Total Parenteral Nutrition (TPN). Model number: 621-100ES, 621-200ES, 621-300ES, and 621-400ES. To deliver a broad range of drugs with use with the B. Braun Medical Inc. Horizon Pump IV Sets.","Multiple serial numbers affected. Model number: 621-100ES, 621-200ES, 621-300ES, and 621-400ES. ",".","28,427","B. Braun Medical Inc. has become aware of an issue with the Outlook ES Safety Infusion System. The key panel may fail to function as intended if the underlying circuitry fails due to intermittent contact. This issue applies specifically to the HOLD button. If this occurs, the Door Processor (DP) will not receive the desired input from the user. This issue can be observed in pumps with key panels manufactured prior to October 17, 2011, key panel revision D. It is possible that if the HOLD button does not function properly when used to stop delivery during an infusion or to extend the hold time, it could lead to adverse health consequences in some patients.",10/24/2012,"10/24/2012",9/18/2013,"09/18/2013"
"Food",64148,"Ongoing","Annie's Homegrown Inc","Berkeley","CA","US","Voluntary: Firm Initiated","Press Release","US only","F-0965-2013","Class II","Annie's Homegrown Rising Crust Four Cheese Pizza. Mozzarella, Provolone, Parmesan and Romano Cheese. Certified Organic, 23.5 oz package. Product UPC: 0 13562-20001 6; Case UPC 1 00 13562 20001 3 Annie's, Inc. 1610 5th Street Berkeley, CA 94710","All product with best by dates between 09 Jan 2013 and 14 Sep 2013.",,"43, 194 cases - all varieties","Annie's Homegrown was notified by their flour supplier that due to a faulty screen at the flour mill, there is the possibility of metal fragments in some of their pizza products. The USDA was also notified as some of the products fall under their jurisdiction.",1/22/2013,"01/22/2013",2/13/2013,"02/13/2013"
"Food",64148,"Ongoing","Annie's Homegrown Inc","Berkeley","CA","US","Voluntary: Firm Initiated","Press Release","US only","F-0966-2013","Class II","Annie's Homegrown Rising Crust Spinach and Mushroom Pizza. Spinach, Portobello and Button mushrooms with a Garlic Parmesan cream sauce.. Certified Organic, 25.0 oz package. Product UPC: 0 13562-20005 4; Case UPC 1 00 13562 20005 1 Annie's, Inc. 1610 5th Street Berkeley, CA 94710","All product with best by dates between 09 Jan 2013 and 14 Sep 2013.",,"43, 194 cases - all varieties","Annie's Homegrown was notified by their flour supplier that due to a faulty screen at the flour mill, there is the possibility of metal fragments in some of their pizza products. The USDA was also notified as some of the products fall under their jurisdiction.",1/22/2013,"01/22/2013",2/13/2013,"02/13/2013"
"Food",64148,"Ongoing","Annie's Homegrown Inc","Berkeley","CA","US","Voluntary: Firm Initiated","Press Release","US only","F-0967-2013","Class II","Annie's Homegrown Rising Crust Four Cheese Pizza. Mozzarella, Provolone, Parmesan and Romano Cheese. 22.5 oz package. Product UPC: 0 13562-20007 8; Case UPC 1 00 13561 20007 5. Annie's, Inc. 1610 5th Street Berkeley, CA 94710","All product with best by dates between 09 Jan 2013 and 14 Sep 2013.",,"43, 194 cases - all varieties","Annie's Homegrown was notified by their flour supplier that due to a faulty screen at the flour mill, there is the possibility of metal fragments in some of their pizza products. The USDA was also notified as some of the products fall under their jurisdiction.",1/22/2013,"01/22/2013",2/13/2013,"02/13/2013"
"Drugs",64149,"Ongoing","Mission Pharmacal Co","Boerne","TX","US","Voluntary: Firm Initiated","Letter","Nationwide","D-602-2013","Class III","Sodium Sulfacetamide 10% and Sulfur 5% Lotion, (NDC 42792-102-01), 25 g Manufactured for: Austin Pharmaceuticals, LLC, Wilmington, DE","Lot# E112, Exp 05/14 Lot# J062, Exp 09/14 ",,"8,437 bottles","Superpotent: Drug product active ingredients were formulated incorrectly (too high) with respect to the label strength.",1/23/2013,"01/23/2013",6/26/2013,"06/26/2013"
"Devices",64150,"Ongoing","B Braun Medical, Inc.","Carrollton","TX","US","Voluntary: Firm Initiated","Letter","Worldwide Disribution: USA (nationwide) and country of: Canada.","Z-2175-2013","Class II","Outlook ES pump is intended for use with B. Braun Medical Inc. Horizon Pump IV Sets. Used to regulate the flow of primary and secondary fluids when positive pressure is required. The infusion system is capable of delivering fluid from a negative head height (when the IV fluid container is lower than the pump), and provides clinically accepted volumetric accuracy for all standard IV fluids, including blood, lipid, and Total Parenteral Nutrition (TPN). Model number: 621-100ES, and 621-200ES. To deliver a broad range of drugs with use with the B. Braun Medical Inc. Horizon Pump IV Sets.","Models 620-100 and 620-200; multiple serial numbers",".","14,161","B. Braun Medical Inc. is informing our customers of a field correction previously performed to address the loss of the drug library in the Outlook Pump Models 620-100 and 620-200. This could have occurred after periods of lost DC (battery) power or out of tolerance low power. This could have led to a delay in therapy, or to delivery of an over or under-dose of a therapy if the user was to rely on the drug library for dosing recommendations or to detect an inappropriate dose. This field correction was originally classified as a non-reportable field upgrade but is now being filed with the FDA as a reportable event.",12/5/2012,"12/05/2012",9/18/2013,"09/18/2013"
"Drugs",64151,"Ongoing","Actelion Pharmaceuticals U.S., Inc.","South San Francisco","CA","US","Voluntary: Firm Initiated","Letter","CA & VA","D-143-2013","Class III","Ventavis (iloprost) Inhalation Solution, 10 mcg/1 mL, Sterile, 30 Single Use Ampules per carton, Manufactured for Actelion Pharmaceuticals US, Inc, 5000 Shoreline Court, Ste 200, South San Francisco, CA 94080, NDC: 66215-302-30. ","Lot #: MA00AD5, Exp: 11/30/2014",,"3 Cartons","Subpotent Drug: OOS (out of specification) assay result at the 12 month stability time point. ",1/16/2013,"01/16/2013",2/13/2013,"02/13/2013"
"Devices",64152,"Ongoing","B Braun Medical, Inc.","Carrollton","TX","US","Voluntary: Firm Initiated","Letter","Nationwide distribution: USA including states of: AR, CA, FL, IL, LA, NC, NJ, NY, MD, ME, MN, SC, TN, TX, VA, WI, and WV.","Z-2188-2013","Class I","Outlook ES pump is intended for use with B. Braun Medical Inc. Horizon Pump IV Sets. Used to regulate the flow of primary and secondary fluids when positive pressure is required. The infusion system is capable of delivering fluid from a negative head height (when the IV fluid container is lower than the pump), and provides clinically accepted volumetric accuracy for all standard IV fluids, including blood, lipid, and Total Parenteral Nutrition (TPN). Model number: 621-300ES and 621-400ES. To deliver a broad range of drugs with use with the B. Braun Medical Inc. Horizon Pump IV Sets.","Model number: 621-300ES and 621-400ES. Multiple serial numbers affected.",,"6,919 ","This notice is being provided in follow up to the field correction initiated by B. Braun Medical Inc. on August 26, 2011 due to an issue in which the Outlook ES Safety Infusion System may halt infusion but the ''RUN'' Light Emitting Diodes (LEDs) on the front display continue to advance as if the pump were infusing. The pump emits a backup alarm, but there are no visual indicators that the infusion has stopped. The issue can potentially be observed in some Outlook ES pump models 300ES and 400ES with Compact Flash card. It is possible that under infusion could occur because the user may see a visual indication that the pump is running when it is not. B. Braun Medical Inc. has identified that not all of the affected Outlook ES pumps were listed in the original notification of this field correction. Although these pumps were not identified in the previous notice, these pumps were upgraded, if available, during field services.",11/14/2012,"11/14/2012",9/25/2013,"09/25/2013"
"Food",64153,"Ongoing","Belmont Confections Inc","Youngstown","OH","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Product was shipped to the following state: Texas","F-0963-2013","Class I","DYMATIZE NUTRITION ELITE Gourmet Cookies & Cream 6-LAYER HI-PROTEIN BAR Label reads in part ''NET WT***INGREDIENTS: Elite Protein Blend***Distributed by: Dymatize Enterprises, Inc. 13737 N. Stemmons FWY, Dallas, TX 75234, (888) 334-LEAN or (972) 732-1990.","Dymatize Nutrition Elite Gourmet Cookies & Cream 1.5oz (42.5g), UPC Code, 705016993147, Lot # 12200A, Best By Date SEP 2013, Lot # 12249A, Best By Date NOV 2013, Lot # 12310A, Best By Date JAN 2014 & Lot # 12353A, Best By Date FEB 2014. Dymatize Nutrition Elite Gourmet Cookies & Cream 3oz (85g), UPC Code, 705016993000, Lot #, 12072A, Best By Date MAY 2013, Lot # 12200A, Best By Date SEP 2013, Lot # 12310A, Best By Date JAN 2014 & Lot # 12353A, Best By Date FEB 2014.",".","195,552/3 oz bars & 73,296/1.5 oz bars","Belmont was notified by their customer, Dymatize, that a consumer complained on an allergic reaction after eating the product. The consumer is allergic to peanuts & peanut protein.",1/15/2013,"01/15/2013",2/6/2013,"02/06/2013"
"Food",64153,"Ongoing","Belmont Confections Inc","Youngstown","OH","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Product was shipped to the following state: Texas","F-0964-2013","Class I","DYMATIZE NUTRITION ELITE Gourmet Fudge Brownie 6-LAYER HI-PROTEIN BAR Label reads in part ''NET WT***INGREDIENTS: Elite Protein Blend***Distributed by: Dymatize Enterprises, Inc. 13737 N. Stemmons FWY, Dallas, TX 75234, (888) 334-LEAN or (972) 732-1990.","Dymatize Nutrition Elite Gourmet Fudge Brownie 1.5oz (42.5g), UPC Code, 705016993130, Lot #, 12199A, Best By Date SEP 2013, Lot # 12244A, Best By Date OCT 2013, Lot # 12311B, Best By Date JAN 2014 & Lot # 12352B, Best By Date FEB 2014. Dymatize Nutrition Elite Gourmet Fudge Brownie 3oz (85g), UPC Code, 705016993079, Lot #, 12084A, Best By Date MAY 2013, Lot # 12199A, Best By Date SEP 2013, Lot # 12205A, Best By Date SEP 2013, Lot # 12311B, Best By Date JAN 2014 & Lot # 12352B, Best By Date FEB 2014.",".","152,280/3 oz bars & 67,536/1,5 oz bars","Belmont was notified by their customer, Dymatize, that a consumer complained on an allergic reaction after eating the product. The consumer is allergic to peanuts & peanut protein.",1/15/2013,"01/15/2013",2/6/2013,"02/06/2013"
"Drugs",64154,"Ongoing","Mylan Pharmaceuticals Inc.","Morgantown","WV","US","Voluntary: Firm Initiated","Letter","Nationwide.","D-137-2013","Class II","Carvedilol Tablets, USP, 12.5 mg, 500-count tablets per bottle, Rx only, Mylan Pharmaceuticals Inc., Morgantown, WV 26505 U.S.A., NDC 0378-3633-05, UPC 3 0378-3633-05 3. ","Lot #: ZCMH12031, ZCMH12032, ZCMH12033, ZCMH12034, Exp 02/14",".","11,580 bottles","Failed Tablet/Capsule Specifications: Product exceeds specification for tablet weight and tablet thickness.",1/16/2013,"01/16/2013",2/6/2013,"02/06/2013"
"Devices",64155,"Ongoing","St Jude Medical Inc","Saint Paul","MN","US","Voluntary: Firm Initiated","Letter","Nationwide Distribution-including DC and the states of AL, AR, AZ, CA, CO, CT, DE, FL, GA, HI, IA, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, NC, NE, NH, NJ, NV, NY, OH, OK, OR, PA, RI, SC, TX, VA, WA, and WI.","Z-0763-2013","Class I","St. Jude Medical, AGA Medical corporation, AMPLATZER TorqVue FX Delivery System. Model #'s: 9-ITVFX06F45/60, 9-ITVFX07F45/60, 9-ITVFX007F45/80, 9-ITVFX08F45/60, 9-ITVFX08F45/80, 9-ITVFX09F45/80, 9-ITVFX10F45/80 9-ITVFX12F45/80, 9-ITVFX13F45/80. Cardiac surgical instrument, used to close atrial septal defects between the right and left atriums.","all batches",,"635","The distal end of the core wire of the TorqVue FX Delivery System could potentially fracture when exposed to a combination of certain cardiac anatomies and usage conditions.",1/18/2013,"01/18/2013",2/20/2013,"02/20/2013"
"Food",64156,"Ongoing","JMT Trading Company, Inc.","South San Francisco","CA","US","Voluntary: Firm Initiated","Telephone","CA Bay area and one location in HI.","F-1130-2013","Class III","Tausi Salted Black Beans, 180 gram (6.34 oz.) can.Ingredient: Black Beans, Water, Iodized salt, sugar and caramel. Distributed by V8 Commercial Co., Inc., San Juan, Metro Manila. Product of the Philippines. UPC 97399 00109","BB:FEB.15, 2013;BB:APR.26, 2013; BB:FEB 15, 2014; BB: APR.11,2013.",,"270 Cartons (100 cans per carton) have been imported since May 2011.","Reports were received of swollen cans of Tausi Salted Black Beans imported from the Philippines.",1/10/2013,"01/10/2013",3/20/2013,"03/20/2013"
"Food",64157,"Ongoing","NBTY Inc.","Bohemia","NY","US","Voluntary: Firm Initiated","Letter","Nationwide and Puerto Rico","F-0981-2013","Class III","PURE PROTEIN PROTEIN SHOT 25g PROTEIN, GRAPE Flavor PROTEIN DRINK 2.9 fl. oz. (86 mL), Product Number 50451, Bulk Number 36753 (Vial), UPC 7 49826 50451 3 (Vial), and Product Number 50452, Bulk Number 36753 (Carton of 6), UPC 7 49826 50452 0 (Carton). --- Carefully Manufactured by Worldwide Sport Nutritional Supplements, Inc. Bayport, NY 11705","Lot # 406844, Expiration Date 04/03/2013; Lot # 439941, Expiration Date 07/26/2013; Lot # 445206, Expiration Date 10/31/2013; Lot # 456438, Expiration Date 11/30/2013 ",,"61,866 vials (sold in cartons of 6)","Lactobacillus plantarum and Lactobacillus brevis were detected in a sample of the product tested by a private laboratory. This is an issue of commercial spoilage. ",12/21/2012,"12/21/2012",2/13/2013,"02/13/2013"
"Food",64157,"Ongoing","NBTY Inc.","Bohemia","NY","US","Voluntary: Firm Initiated","Letter","Nationwide and Puerto Rico","F-0980-2013","Class III","MET-Rx EXTREME THERMO RAGE WATERMELON DIETARY SUPPLEMENT, 8 FL. OZ. (240 mL) , Product Number 50390 (Bulk number 50389), UPC 7 86560 50389 1, Label Revision 00B --- Manufactured in the USA by MET-RX Nutrition, Inc. Boca Raton, FL 33487 ","Lot # 430855, Expiration Date 12/21/12; Lot # 430856, Expiration Date 12/29/12 ",,"40,668 bottles (shipped and sold in cases of 12)","Acetobacter lovaniensis was detected in a sample of the product tested by a private laboratory. This is an issue of commercial spoilage. ",12/21/2012,"12/21/2012",2/13/2013,"02/13/2013"
"Devices",64158,"Ongoing","Codman & Shurtleff, Inc.","Raynham","MA","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution - USA (nationwide) and Internationally to Austria, Belgium, Canada, Chile, Costa, Rica, Czech Republic, Denmark, France, Germany, Great Britian/UK, Ireland, Italy, Lithuania, Malaysia, Netherlands, New Zealand, Norway, Poland, Portugal, Singapore, Slovakia, Spain, and Switzerland.","Z-0845-2013","Class II","NEUROPATH 5Fx100 GUIDING CATH HH Product Code: GHH51000000 Intended for use in the coronary, peripheral, and neurovasculature for intravascular introduction of interventional/diagnostic devices","All unexpired lots",".","50 units","Sterility of device may be compromised due to lack of package integrity",1/11/2013,"01/11/2013",2/27/2013,"02/27/2013"
"Devices",64158,"Ongoing","Codman & Shurtleff, Inc.","Raynham","MA","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution - USA (nationwide) and Internationally to Austria, Belgium, Canada, Chile, Costa, Rica, Czech Republic, Denmark, France, Germany, Great Britian/UK, Ireland, Italy, Lithuania, Malaysia, Netherlands, New Zealand, Norway, Poland, Portugal, Singapore, Slovakia, Spain, and Switzerland.","Z-0860-2013","Class II","NEUROPATH 6Fx90 GUIDING CATH ST Product Code: GST60900000 Intended for use in the coronary, peripheral, and neurovasculature for intravascular introduction of interventional/diagnostic devices","All unexpired lots",".","268 units","Sterility of device may be compromised due to lack of package integrity",1/11/2013,"01/11/2013",2/27/2013,"02/27/2013"
"Devices",64158,"Ongoing","Codman & Shurtleff, Inc.","Raynham","MA","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution - USA (nationwide) and Internationally to Austria, Belgium, Canada, Chile, Costa, Rica, Czech Republic, Denmark, France, Germany, Great Britian/UK, Ireland, Italy, Lithuania, Malaysia, Netherlands, New Zealand, Norway, Poland, Portugal, Singapore, Slovakia, Spain, and Switzerland.","Z-0857-2013","Class II","NEUROPATH 5Fx90 GUIDING CATH MPD Product Code: GMD50900000 Intended for use in the coronary, peripheral, and neurovasculature for intravascular introduction of interventional/diagnostic devices","All unexpired lots",".","202 units","Sterility of device may be compromised due to lack of package integrity",1/11/2013,"01/11/2013",2/27/2013,"02/27/2013"
"Devices",64158,"Ongoing","Codman & Shurtleff, Inc.","Raynham","MA","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution - USA (nationwide) and Internationally to Austria, Belgium, Canada, Chile, Costa, Rica, Czech Republic, Denmark, France, Germany, Great Britian/UK, Ireland, Italy, Lithuania, Malaysia, Netherlands, New Zealand, Norway, Poland, Portugal, Singapore, Slovakia, Spain, and Switzerland.","Z-0844-2013","Class II","NEUROPATH 6Fx90 GUIDING CATH HH Product Code: GHH60900000 Intended for use in the coronary, peripheral, and neurovasculature for intravascular introduction of interventional/diagnostic devices","All unexpired lots",".","56 units","Sterility of device may be compromised due to lack of package integrity",1/11/2013,"01/11/2013",2/27/2013,"02/27/2013"
"Devices",64158,"Ongoing","Codman & Shurtleff, Inc.","Raynham","MA","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution - USA (nationwide) and Internationally to Austria, Belgium, Canada, Chile, Costa, Rica, Czech Republic, Denmark, France, Germany, Great Britian/UK, Ireland, Italy, Lithuania, Malaysia, Netherlands, New Zealand, Norway, Poland, Portugal, Singapore, Slovakia, Spain, and Switzerland.","Z-0865-2013","Class II","NEUROPATH 6Fx100 GUIDING CATH MP Product Code: GMC61000000 Intended for use in the coronary, peripheral, and neurovasculature for intravascular introduction of interventional/diagnostic devices","All unexpired lots",".","522 units","Sterility of device may be compromised due to lack of package integrity",1/11/2013,"01/11/2013",2/27/2013,"02/27/2013"
"Devices",64158,"Ongoing","Codman & Shurtleff, Inc.","Raynham","MA","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution - USA (nationwide) and Internationally to Austria, Belgium, Canada, Chile, Costa, Rica, Czech Republic, Denmark, France, Germany, Great Britian/UK, Ireland, Italy, Lithuania, Malaysia, Netherlands, New Zealand, Norway, Poland, Portugal, Singapore, Slovakia, Spain, and Switzerland.","Z-0842-2013","Class II","NEUROPATH 6Fx90 GUIDING CATH MPC Product Code: GMC60900000 Intended for use in the coronary, peripheral, and neurovasculature for intravascular introduction of interventional/diagnostic devices","All unexpired lots",".","867 units","Sterility of device may be compromised due to lack of packaging integrity",1/11/2013,"01/11/2013",2/27/2013,"02/27/2013"
"Devices",64158,"Ongoing","Codman & Shurtleff, Inc.","Raynham","MA","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution - USA (nationwide) and Internationally to Austria, Belgium, Canada, Chile, Costa, Rica, Czech Republic, Denmark, France, Germany, Great Britian/UK, Ireland, Italy, Lithuania, Malaysia, Netherlands, New Zealand, Norway, Poland, Portugal, Singapore, Slovakia, Spain, and Switzerland.","Z-0849-2013","Class II","NEUROPATH 6Fx100 GUIDING CATH ST Product Code: GST61000000 Intended for use in the coronary, peripheral, and neurovasculature for intravascular introduction of interventional/diagnostic devices","All unexpired lots",".","266 units","Sterility of device may be compromised due to lack of package integrity",1/11/2013,"01/11/2013",2/27/2013,"02/27/2013"
"Devices",64158,"Ongoing","Codman & Shurtleff, Inc.","Raynham","MA","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution - USA (nationwide) and Internationally to Austria, Belgium, Canada, Chile, Costa, Rica, Czech Republic, Denmark, France, Germany, Great Britian/UK, Ireland, Italy, Lithuania, Malaysia, Netherlands, New Zealand, Norway, Poland, Portugal, Singapore, Slovakia, Spain, and Switzerland.","Z-0851-2013","Class II","NEUROPATH 6Fx100 GUIDING CATH MC Product Code: GCB61000000 Intended for use in the coronary, peripheral, and neurovasculature for intravascular introduction of interventional/diagnostic devices","All unexpired lots",".","34 units","Sterility of device may be compromised due to lack of package integrity",1/11/2013,"01/11/2013",2/27/2013,"02/27/2013"
"Devices",64158,"Ongoing","Codman & Shurtleff, Inc.","Raynham","MA","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution - USA (nationwide) and Internationally to Austria, Belgium, Canada, Chile, Costa, Rica, Czech Republic, Denmark, France, Germany, Great Britian/UK, Ireland, Italy, Lithuania, Malaysia, Netherlands, New Zealand, Norway, Poland, Portugal, Singapore, Slovakia, Spain, and Switzerland.","Z-0861-2013","Class II","NEUROPATH 5Fx90 GUIDING CATH HH Product Code: GHH50900000 Intended for use in the coronary, peripheral, and neurovasculature for intravascular introduction of interventional/diagnostic devices","All unexpired lots",".","141 units","Sterility of device may be compromised due to lack of package integrity",1/11/2013,"01/11/2013",2/27/2013,"02/27/2013"
"Devices",64158,"Ongoing","Codman & Shurtleff, Inc.","Raynham","MA","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution - USA (nationwide) and Internationally to Austria, Belgium, Canada, Chile, Costa, Rica, Czech Republic, Denmark, France, Germany, Great Britian/UK, Ireland, Italy, Lithuania, Malaysia, Netherlands, New Zealand, Norway, Poland, Portugal, Singapore, Slovakia, Spain, and Switzerland.","Z-0852-2013","Class II","NEUROPATH 6Fx100 GUIDING CATH S2 Product Code: GSM61000000 Intended for use in the coronary, peripheral, and neurovasculature for intravascular introduction of interventional/diagnostic devices","All unexpired lots",".","129 units","Sterility of device may be compromised due to lack of package integrity",1/11/2013,"01/11/2013",2/27/2013,"02/27/2013"
"Devices",64158,"Ongoing","Codman & Shurtleff, Inc.","Raynham","MA","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution - USA (nationwide) and Internationally to Austria, Belgium, Canada, Chile, Costa, Rica, Czech Republic, Denmark, France, Germany, Great Britian/UK, Ireland, Italy, Lithuania, Malaysia, Netherlands, New Zealand, Norway, Poland, Portugal, Singapore, Slovakia, Spain, and Switzerland.","Z-0843-2013","Class II","NEUROPATH 5Fx90 GUIDING CATH S2 Product Code: GSM50900000 Intended for use in the coronary, peripheral, and neurovasculature for intravascular introduction of interventional/diagnostic devices","All unexpired lots",".","19 units","Sterility of device may be compromised due to lack of package integrity",1/11/2013,"01/11/2013",2/27/2013,"02/27/2013"
"Devices",64158,"Ongoing","Codman & Shurtleff, Inc.","Raynham","MA","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution - USA (nationwide) and Internationally to Austria, Belgium, Canada, Chile, Costa, Rica, Czech Republic, Denmark, France, Germany, Great Britian/UK, Ireland, Italy, Lithuania, Malaysia, Netherlands, New Zealand, Norway, Poland, Portugal, Singapore, Slovakia, Spain, and Switzerland.","Z-0848-2013","Class II","NEUROPATH 5Fx100 GUIDING CATH MP Product Code:GMD51000000 Intended for use in the coronary, peripheral, and neurovasculature for intravascular introduction of interventional/diagnostic devices","All unexpired lots",".","273 units","Sterility of device may be compromised due to lack of package integrity",1/11/2013,"01/11/2013",2/27/2013,"02/27/2013"
"Devices",64158,"Ongoing","Codman & Shurtleff, Inc.","Raynham","MA","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution - USA (nationwide) and Internationally to Austria, Belgium, Canada, Chile, Costa, Rica, Czech Republic, Denmark, France, Germany, Great Britian/UK, Ireland, Italy, Lithuania, Malaysia, Netherlands, New Zealand, Norway, Poland, Portugal, Singapore, Slovakia, Spain, and Switzerland.","Z-0855-2013","Class II","NEUROPATH 5Fx90 GUIDING CATH MPC Product Code: GMC50900000 Intended for use in the coronary, peripheral, and neurovasculature for intravascular introduction of interventional/diagnostic devices","All unexpired lots",".","202 units","Sterility of device may be compromised due to lack of package integrity",1/11/2013,"01/11/2013",2/27/2013,"02/27/2013"
"Devices",64158,"Ongoing","Codman & Shurtleff, Inc.","Raynham","MA","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution - USA (nationwide) and Internationally to Austria, Belgium, Canada, Chile, Costa, Rica, Czech Republic, Denmark, France, Germany, Great Britian/UK, Ireland, Italy, Lithuania, Malaysia, Netherlands, New Zealand, Norway, Poland, Portugal, Singapore, Slovakia, Spain, and Switzerland.","Z-0846-2013","Class II","NEUROPATH 5Fx100 GUIDING CATH HH Product Code: GMC51000000 Intended for use in the coronary, peripheral, and neurovasculature for intravascular introduction of interventional/diagnostic devices","All unexpired lots",".","234 units","Sterility of device may be compromised due to lack of package integrity",1/11/2013,"01/11/2013",2/27/2013,"02/27/2013"
"Devices",64158,"Ongoing","Codman & Shurtleff, Inc.","Raynham","MA","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution - USA (nationwide) and Internationally to Austria, Belgium, Canada, Chile, Costa, Rica, Czech Republic, Denmark, France, Germany, Great Britian/UK, Ireland, Italy, Lithuania, Malaysia, Netherlands, New Zealand, Norway, Poland, Portugal, Singapore, Slovakia, Spain, and Switzerland.","Z-0847-2013","Class II","NEUROPATH 6Fx100 GUIDING CATH MPD Product Code: GMD60900000 Intended for use in the coronary, peripheral, and neurovasculature for intravascular introduction of interventional/diagnostic devices","All unexpired lots",".","867 units","Sterility of device may be compromised due to lack of package integrity",1/11/2013,"01/11/2013",2/27/2013,"02/27/2013"
"Devices",64158,"Ongoing","Codman & Shurtleff, Inc.","Raynham","MA","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution - USA (nationwide) and Internationally to Austria, Belgium, Canada, Chile, Costa, Rica, Czech Republic, Denmark, France, Germany, Great Britian/UK, Ireland, Italy, Lithuania, Malaysia, Netherlands, New Zealand, Norway, Poland, Portugal, Singapore, Slovakia, Spain, and Switzerland.","Z-0859-2013","Class II","NEUROPATH 5Fx90 GUIDING CATH ST Product Code: GST50900000 Intended for use in the coronary, peripheral, and neurovasculature for intravascular introduction of interventional/diagnostic devices","All unexpired lots",".","46 units","Sterility of device may be compromised due to lack of package integrity",1/11/2013,"01/11/2013",2/27/2013,"02/27/2013"
"Devices",64158,"Ongoing","Codman & Shurtleff, Inc.","Raynham","MA","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution - USA (nationwide) and Internationally to Austria, Belgium, Canada, Chile, Costa, Rica, Czech Republic, Denmark, France, Germany, Great Britian/UK, Ireland, Italy, Lithuania, Malaysia, Netherlands, New Zealand, Norway, Poland, Portugal, Singapore, Slovakia, Spain, and Switzerland.","Z-0853-2013","Class II","NEUROPATH 5Fx100 GUIDING CATH MC Product Code: GCB51000000 Intended for use in the coronary, peripheral, and neurovasculature for intravascular introduction of interventional/diagnostic devices","All unexpired lots",".","5 units","Sterility of device may be compromised due to lack of package integrity",1/11/2013,"01/11/2013",2/27/2013,"02/27/2013"
"Devices",64158,"Ongoing","Codman & Shurtleff, Inc.","Raynham","MA","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution - USA (nationwide) and Internationally to Austria, Belgium, Canada, Chile, Costa, Rica, Czech Republic, Denmark, France, Germany, Great Britian/UK, Ireland, Italy, Lithuania, Malaysia, Netherlands, New Zealand, Norway, Poland, Portugal, Singapore, Slovakia, Spain, and Switzerland.","Z-0856-2013","Class II","NEUROPATH 6Fx100 GUIDING CATH MP Product Code: GMD61000000 Intended for use in the coronary, peripheral, and neurovasculature for intravascular introduction of interventional/diagnostic devices","All unexpired lots",".","1548 units","Sterility of device may be compromised due to lack of package integrity",1/11/2013,"01/11/2013",2/27/2013,"02/27/2013"
"Devices",64158,"Ongoing","Codman & Shurtleff, Inc.","Raynham","MA","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution - USA (nationwide) and Internationally to Austria, Belgium, Canada, Chile, Costa, Rica, Czech Republic, Denmark, France, Germany, Great Britian/UK, Ireland, Italy, Lithuania, Malaysia, Netherlands, New Zealand, Norway, Poland, Portugal, Singapore, Slovakia, Spain, and Switzerland.","Z-0858-2013","Class II","NEUROPATH 5Fx100 GUIDING CATH ST Product Code: GST51000000 Intended for use in the coronary, peripheral, and neurovasculature for intravascular introduction of interventional/diagnostic devices","All unexpired lots",".","46 units","Sterility of device may be compromised due to lack of package integrity",1/11/2013,"01/11/2013",2/27/2013,"02/27/2013"
"Devices",64158,"Ongoing","Codman & Shurtleff, Inc.","Raynham","MA","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution - USA (nationwide) and Internationally to Austria, Belgium, Canada, Chile, Costa, Rica, Czech Republic, Denmark, France, Germany, Great Britian/UK, Ireland, Italy, Lithuania, Malaysia, Netherlands, New Zealand, Norway, Poland, Portugal, Singapore, Slovakia, Spain, and Switzerland.","Z-0854-2013","Class II","NEUROPATH 5Fx90 GUIDING CATH MCV Product Code: GCB50900000 Intended for use in the coronary, peripheral, and neurovasculature for intravascular introduction of interventional/diagnostic devices","All unexpired lots",".","5 units","Sterility of device may be compromised due to lack of package integrity",1/11/2013,"01/11/2013",2/27/2013,"02/27/2013"
"Devices",64158,"Ongoing","Codman & Shurtleff, Inc.","Raynham","MA","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution - USA (nationwide) and Internationally to Austria, Belgium, Canada, Chile, Costa, Rica, Czech Republic, Denmark, France, Germany, Great Britian/UK, Ireland, Italy, Lithuania, Malaysia, Netherlands, New Zealand, Norway, Poland, Portugal, Singapore, Slovakia, Spain, and Switzerland.","Z-0850-2013","Class II","NEUROPATH 5Fx100 GUIDING CATH S2 Product Code: GSM51000000 Intended for use in the coronary, peripheral, and neurovasculature for intravascular introduction of interventional/diagnostic devices","All unexpired lots",".","32 units","Sterility of device may be compromised due to lack of package integrity",1/11/2013,"01/11/2013",2/27/2013,"02/27/2013"
"Devices",64158,"Ongoing","Codman & Shurtleff, Inc.","Raynham","MA","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution - USA (nationwide) and Internationally to Austria, Belgium, Canada, Chile, Costa, Rica, Czech Republic, Denmark, France, Germany, Great Britian/UK, Ireland, Italy, Lithuania, Malaysia, Netherlands, New Zealand, Norway, Poland, Portugal, Singapore, Slovakia, Spain, and Switzerland.","Z-0862-2013","Class II","NEUROPATH 6Fx90 GUIDING CATH MCV Product Code: GCB60900000 Intended for use in the coronary, peripheral, and neurovasculature for intravascular introduction of interventional/diagnostic devices","All unexpired lots",".","10 units","Sterility of device may be compromised due to lack of package integrity",1/11/2013,"01/11/2013",2/27/2013,"02/27/2013"
"Devices",64158,"Ongoing","Codman & Shurtleff, Inc.","Raynham","MA","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution - USA (nationwide) and Internationally to Austria, Belgium, Canada, Chile, Costa, Rica, Czech Republic, Denmark, France, Germany, Great Britian/UK, Ireland, Italy, Lithuania, Malaysia, Netherlands, New Zealand, Norway, Poland, Portugal, Singapore, Slovakia, Spain, and Switzerland.","Z-0863-2013","Class II","NEUROPATH 6Fx90 GUIDING CATH S2 Product Code: GSM60900000 Intended for use in the coronary, peripheral, and neurovasculature for intravascular introduction of interventional/diagnostic devices","All unexpired lots",".","64 units","Sterility of device may be compromised due to lack of package integrity",1/11/2013,"01/11/2013",2/27/2013,"02/27/2013"
"Devices",64158,"Ongoing","Codman & Shurtleff, Inc.","Raynham","MA","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution - USA (nationwide) and Internationally to Austria, Belgium, Canada, Chile, Costa, Rica, Czech Republic, Denmark, France, Germany, Great Britian/UK, Ireland, Italy, Lithuania, Malaysia, Netherlands, New Zealand, Norway, Poland, Portugal, Singapore, Slovakia, Spain, and Switzerland.","Z-0864-2013","Class II","NEUROPATH 6Fx100 GUIDING CATH HH Product Code: GHH61000000 Intended for use in the coronary, peripheral, and neurovasculature for intravascular introduction of interventional/diagnostic devices","All unexpired lots",".","25","Sterility of device may be compromised due to lack of package integrity",1/11/2013,"01/11/2013",2/27/2013,"02/27/2013"
"Devices",64159,"Ongoing","Synthes USA HQ, Inc.","West Chester","PA","US","Voluntary: Firm Initiated","Letter","USA Nationwide Distribution including the states of AL, AR, AK, CA, FL, ID, KS, LA, MD, MA, MO, NJ, NY, OH, PA, TN, TX, and VA.","Z-0941-2013","Class II","Large Combination Clamp/Large External Fixation System, Part Number 390.005 Product Usage: Synthes Large External Fixation is intended for use to provide treatment for long bone and pelvic fractures that require external fixation. "," Lot Numbers 6602070, 6582333, 6581191, and 6581193",,"136","The L1 hex nuts, used to tighten the Large Combination Clamp, were oversized and the 11 mm sockets and wrenches will not fit on the hex nuts.",1/11/2013,"01/11/2013",3/20/2013,"03/20/2013"
"Devices",64160,"Terminated","Medacta Usa Inc","Camarillo","CA","US","Voluntary: Firm Initiated","E-Mail","US Nationwide Distribution including the states of Arizona, California, Idaho, Illinois, North Carolina, Ohio, Utah, Washington and US Virgin Islands","Z-0791-2013","Class II","Medacta Quadra Trial Broach size 0 part # 01.10.10.045, for use with the Medacta Total Hip Prosthesis System. Product Usage - used to broach the intramedullary canal of the femur in order to create space for the femoral stem during a hip replacement surgery.","Lot/Unit Codes: 075023, 075064, 084000, 084001, 084326, 084743, 084815, 085202, 085455",,"26 pieces U.S.A. (226 pieces Worldwide)","The tip of the Quadra Trial Broach size 0, broke during a surgery.",12/17/2012,"12/17/2012",2/13/2013,"02/13/2013"
"Food",64161,"Ongoing","Mann Packing Co Inc","Salinas","CA","US","Voluntary: Firm Initiated","Letter","AZ, MN, CA , TX, ND, WI, NE, WA, AL, FL, NV , CO, AL, MO, KY, PA, SC.","F-0989-2013","Class III","Stringless Sugar Snap Peas, Sunny Shores' Mann's. Net Wt 8 oz (227 g); Perishable, Preservative Free, keep refrigerated. Product of Guatemala UPC 7 16519 13004 Distributed by Mann Packing, Salinas, CA.","Best by Date: January 22, 2013.",,"~3186 pounds","California Department of Food and Agriculture randomly sampled Sunny Shores Mann's snap peas and found them to contain 0.278 and 0.195 ppm of Carbendazim. Carbendazim is a pesticide that is not allowed in the US but is approved for use in the EU>",1/19/2013,"01/19/2013",2/20/2013,"02/20/2013"
"Devices",64162,"Ongoing","Beckman Coulter Inc.","Brea","CA","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution - USA Nationwide and the countries of: Canada, Brazil, Colombia, Mexico, Puerto Rico, Venezuela, Guam, Honduras, Peru, Ecuador, Costa Rica.","Z-0958-2013","Class II","Creatinine, Part Numbers OSR6178, OSR6678 Product Usage: System reagent for the quantitative determination of Creatinine in human serum and urine on Beckman Coulter AU analyzers. ","All",".","57,962 units (50,452 units in the US)","The recall was initiated by Beckman Coulter because they are including additional information and instructions in the Creatinine (OSR6x78) IFU and Setting Sheet, relating to calibration stability and quality control frequency to assure product performance.",12/28/2012,"12/28/2012",3/27/2013,"03/27/2013"
"Devices",64163,"Ongoing","Ormco/Sybronendo","Glendora","CA","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution - USA and the country of Canada.","Z-0765-2013","Class II","Sybron Endo Lightspeed: LSX Files, 25MM, Part Numbers: 835-2525; LSX Files, 25MM Assorted Kit, Part Numbers: 835-2455; LSX Files, 30MM, Part Numbers: 835-2031. An engine-driven rotary endodontic instrument used during endodontic procedures for cleaning and shaping the root canal. ","Part # 835-2525, Lot # 091274189. Part # 835-2455, Lot # 091272054, 091279295, 101200609, 101200610, 101200612. Part # 835-2031, Lot # 091268204. ",,"740 units","The length markings on the Lightspeed LSX files were wrong. ",12/12/2012,"12/12/2012",2/13/2013,"02/13/2013"
"Devices",64164,"Completed","Bion Enterprises Ltd","Des Plaines","IL","US","Voluntary: Firm Initiated","E-Mail","Worldwide Distribution - United States (nationwide) in the states of IN, SC and the countries of Canada (Toronto); South Africa (Randburg) and Brazil (Rio de Janeiro)","Z-1477-2013","Class III","Plastic bottle containing 10.5 mL of IgG Conjugate Product Usage: Product is a used as a counterstain for various indirect fluorescent assay kits ","Product Code: CCG-9912; Lot: CCG-0280",".","207 units","Affected products have a labeled expiration date of one year too long.",1/23/2013,"01/23/2013",6/12/2013,"06/12/2013"
"Devices",64164,"Completed","Bion Enterprises Ltd","Des Plaines","IL","US","Voluntary: Firm Initiated","E-Mail","Worldwide Distribution - United States (nationwide) in the states of IN, SC and the countries of Canada (Toronto); South Africa (Randburg) and Brazil (Rio de Janeiro)","Z-1479-2013","Class III","Plastic bottle containing 3.5 mL of IgG FITC Conjugate Product Usage: Product is a used as a counterstain for various indirect fluorescent assay kits ","Product Code: CCG-9972; Lot: CCG-0281",".","504 units","Affected products have a labeled expiration date of one year too long.",1/23/2013,"01/23/2013",6/12/2013,"06/12/2013"
"Devices",64164,"Completed","Bion Enterprises Ltd","Des Plaines","IL","US","Voluntary: Firm Initiated","E-Mail","Worldwide Distribution - United States (nationwide) in the states of IN, SC and the countries of Canada (Toronto); South Africa (Randburg) and Brazil (Rio de Janeiro)","Z-1478-2013","Class III","Plastic bottle containing 10.5 mL of IgM Conjugate Product Usage: Product is a used as a counterstain for various indirect fluorescent assay kits ","Product Code: CCM-9914; Lot: CCM-0281",".","201 units","Affected products have a labeled expiration date of one year too long.",1/23/2013,"01/23/2013",6/12/2013,"06/12/2013"
"Devices",64165,"Ongoing","Elekta, Inc.","Atlanta","GA","US","Voluntary: Firm Initiated","Other","Nationwide Distribution-DC, Puerto Rico and the states of AL, AK, AZ, CA, CO, CT, FL, GA, IL, IA, KY, MD, MA, MI, MN, MS, MT, NE, NV, NH, NJ, NM, NY, NC, OH, OK, OR, PA, SC, TN, TX, VT, VA, WA, WV, and WI.","Z-0931-2013","Class II","Elekta Synergy XVI. Radiation Therapy Digital Imager. Product XVI R3.5.1, R4.2.1, and R4.5.1 Used as part of radiation therapy treatment process.","151055, 151700, 151809, 151695, 151479, 151696, 151867, 151704, 151765, 151860, 151024, 151521, 151803, 152217, 151774, 152220, 151626, 151842, 151847, 151446, 151801, 151953, 151664, 151751, 151352, 151298, 151728, 151504, 151981, 151705, 151977, 152123, 152126, 151955, 105982, 151160, 151634, 151954, 151416, 151074, 151587, 151729, 151694, 151965, 151418, 151674, 151259, 151698, 151699, 152043, 151636, 151811, 151568, 151258, 151584, 151423, 151623, 151627, 151507, 151640, 151933, 151340, 151722, 151810, 151051, 151411, 151360, 151595, 151433, 151611, 152008, 151151, 151714, 151653, 151675, 151538, 152031, 151523, 151519, 151432, 151783, 151410, 151371, 151084, 151387, 151978, 151530, 151328, 151689, 151567, 151598, 151760, 151269, 151557, 151558, 151789, 151398, 151632, 152214, 151301, 151441, 151256, 151391, 151038, 151585, 151327, 151326, 151250, 151130, 151828, 151245, 151672, 105803, 151073, 151956, 152232, 151319, 151959, 151960, 151958, 151435, 151779, 151969, 151848, 151875, 151881, 151882, 151736, 152023, 152080, 152079, 152064, 151734, 151763, 152154, 151110, 151363, 151216, 151173, 151678, 151467, 151961, 151178, 152091, 152051, 152115, 152116, 151708, 152176, 152192, 152098, 152200, 152174, 152246, 152364, 152673, 152425, 151156, 151764, 151886, 151076, 151369, 152175, 105941",,"164","The DICOM tags do not contain sufficient information for XVI to identify the different volumes that have the same name.",12/19/2012,"12/19/2012",3/20/2013,"03/20/2013"
"Biologics",64166,"Terminated","OneBlood, Inc.","Lauderhill","FL","US","Voluntary: Firm Initiated","Telephone","Swaziland; Florida; New York","B-1068-13","Class II","Cryoprecipitated AHF","W036809819156; ",,"1","Blood products, collected from a donor for whom donor suitability was not adequately determined, were distributed.",1/16/2013,"01/16/2013",5/8/2013,"05/08/2013"
"Biologics",64166,"Terminated","OneBlood, Inc.","Lauderhill","FL","US","Voluntary: Firm Initiated","Telephone","Swaziland; Florida; New York","B-1069-13","Class III","Blood and Blood Products for Reprocessing","W036809308115; ",,"1","Blood products, collected from a donor for whom donor suitability was not adequately determined, were distributed.",1/16/2013,"01/16/2013",5/8/2013,"05/08/2013"
"Biologics",64166,"Terminated","OneBlood, Inc.","Lauderhill","FL","US","Voluntary: Firm Initiated","Telephone","Swaziland; Florida; New York","B-1066-13","Class II","Red Blood Cells","W036809308115; ",,"1","Blood products, collected from a donor for whom donor suitability was not adequately determined, were distributed.",1/16/2013,"01/16/2013",5/8/2013,"05/08/2013"
"Biologics",64166,"Terminated","OneBlood, Inc.","Lauderhill","FL","US","Voluntary: Firm Initiated","Telephone","Swaziland; Florida; New York","B-1067-13","Class II","Platelets Pooled Leukocytes Reduced","W036809816399; ",,"1","Blood products, collected from a donor for whom donor suitability was not adequately determined, were distributed.",1/16/2013,"01/16/2013",5/8/2013,"05/08/2013"
"Biologics",64167,"Terminated","Community Blood Centers of Florida, Inc.","Miami","FL","US","Voluntary: Firm Initiated","Telephone","Florida","B-1070-13","Class II","Red Blood Cells","W036812464017; ",,"1","Blood product, which was collected from a donor in which donor suitability was not adequately determined, was distributed.",1/11/2013,"01/11/2013",5/8/2013,"05/08/2013"
"Biologics",64168,"Terminated","Community Blood Centers of South Florida, Inc.","Hialeah","FL","US","Voluntary: Firm Initiated","Telephone","Florida","B-1071-13","Class II","Red Blood Cells","W036812581268; ",,"1","Blood products, which were collected from a donor in which donor suitability was not adequately determined, were distributed. ",1/14/2013,"01/14/2013",5/8/2013,"05/08/2013"
"Biologics",64168,"Terminated","Community Blood Centers of South Florida, Inc.","Hialeah","FL","US","Voluntary: Firm Initiated","Telephone","Florida","B-1072-13","Class II","Platelets Pooled Leukocytes Reduced","W036812845751; ",,"1","Blood products, which were collected from a donor in which donor suitability was not adequately determined, were distributed. ",1/14/2013,"01/14/2013",5/8/2013,"05/08/2013"
"Biologics",64168,"Terminated","Community Blood Centers of South Florida, Inc.","Hialeah","FL","US","Voluntary: Firm Initiated","Telephone","Florida","B-1073-13","Class III","Blood and Blood Products for Reprocessing","W036812581268; ",,"1","Blood products, which were collected from a donor in which donor suitability was not adequately determined, were distributed. ",1/14/2013,"01/14/2013",5/8/2013,"05/08/2013"
"Biologics",64169,"Terminated","Community Blood Centers of South Florida, Inc.","Hialeah","FL","US","Voluntary: Firm Initiated","Telephone","Switzerland; Florida","B-1074-13","Class II","Red Blood Cells","W036810087981; ",,"1","Blood products, which were collected from a donor in which donor suitability was not adequately determined, were distributed.",1/10/2013,"01/10/2013",5/8/2013,"05/08/2013"
"Biologics",64169,"Terminated","Community Blood Centers of South Florida, Inc.","Hialeah","FL","US","Voluntary: Firm Initiated","Telephone","Switzerland; Florida","B-1075-13","Class II","Cryoprecipitated AHF","W036810087981; ",,"1","Blood products, which were collected from a donor in which donor suitability was not adequately determined, were distributed.",1/10/2013,"01/10/2013",5/8/2013,"05/08/2013"
"Biologics",64169,"Terminated","Community Blood Centers of South Florida, Inc.","Hialeah","FL","US","Voluntary: Firm Initiated","Telephone","Switzerland; Florida","B-1076-13","Class III","Blood and Blood Products for Reprocessing","W036810087981; ",,"1","Blood products, which were collected from a donor in which donor suitability was not adequately determined, were distributed.",1/10/2013,"01/10/2013",5/8/2013,"05/08/2013"
"Biologics",64170,"Terminated","Community Blood Centers of Florida, Inc.","Miami","FL","US","Voluntary: Firm Initiated","Telephone","New Zealand; Florida","B-1079-13","Class II","Red Blood Cells","W036812426906; ",,"1","Blood products, which were collected from a donor in which donor suitability was not adequately determined, were distributed.",1/7/2013,"01/07/2013",5/8/2013,"05/08/2013"
"Biologics",64170,"Terminated","Community Blood Centers of Florida, Inc.","Miami","FL","US","Voluntary: Firm Initiated","Telephone","New Zealand; Florida","B-1078-13","Class III","Blood and Blood Products for Reprocessing","W036811130540; W036812426906; ",,"2","Blood products, which were collected from a donor in which donor suitability was not adequately determined, were distributed.",1/7/2013,"01/07/2013",5/8/2013,"05/08/2013"
"Biologics",64170,"Terminated","Community Blood Centers of Florida, Inc.","Miami","FL","US","Voluntary: Firm Initiated","Telephone","New Zealand; Florida","B-1077-13","Class II","Red Blood Cells Irradiated","W036811130540; ",,"1","Blood products, which were collected from a donor in which donor suitability was not adequately determined, were distributed.",1/7/2013,"01/07/2013",5/8/2013,"05/08/2013"
"Biologics",64171,"Terminated","Blood Assurance Inc","Chattanooga","TN","US","Voluntary: Firm Initiated","FAX","Tennessee; Indiana","B-1080-13","Class II","Red Blood Cells Leukocytes Reduced","W043212079287; ",,"1","Blood products, collected from a donor who was at risk for variant Creutzfeldt-Jakob disease (vCJD), were distributed.",1/4/2013,"01/04/2013",5/8/2013,"05/08/2013"
"Biologics",64171,"Terminated","Blood Assurance Inc","Chattanooga","TN","US","Voluntary: Firm Initiated","FAX","Tennessee; Indiana","B-1081-13","Class II","Blood and Blood Products for Reprocessing","W043212079287; ",,"1","Blood products, collected from a donor who was at risk for variant Creutzfeldt-Jakob disease (vCJD), were distributed.",1/4/2013,"01/04/2013",5/8/2013,"05/08/2013"
"Devices",64173,"Ongoing","Synthes USA HQ, Inc.","West Chester","PA","US","Voluntary: Firm Initiated","Letter","Distributed in the states of AL, CA, MS, MO, NJ, OR, and TN.","Z-0938-2013","Class II","Synthes Spine 5.2mm Titanium Click ' X Pedicle Screw Dual Core 40 mm Thread Length, Part Number 487.072. Intended to provide precise and segmental stabilization of the spine in skeletally mature patients.","Lot Number 7542279",,"18","Lot number 7542279, of the 45 mm Click 'X Pedicle Screw (Part number 487.072), was incorrectly etched as ''Click 'X Pedicle Screw 05.2 L40 TAN violet'' although the actual length of the screw is 45 mm.",1/11/2013,"01/11/2013",3/20/2013,"03/20/2013"
"Biologics",64174,"Terminated","Hoxworth Blood Center UC Medical Center","Cincinnati","OH","US","Voluntary: Firm Initiated","Telephone","Ohio","B-1083-13","Class II","Fresh Frozen Plasma","W037712012893; W037711179346; ",,"2","Blood products, collected from a donor who was at risk for variant Creutzfeldt-Jakob disease (vCJD), were distributed.",10/18/2012,"10/18/2012",5/8/2013,"05/08/2013"
"Biologics",64174,"Terminated","Hoxworth Blood Center UC Medical Center","Cincinnati","OH","US","Voluntary: Firm Initiated","Telephone","Ohio","B-1082-13","Class II","Cryoprecipitated AHF, Pooled","W037711505342; ",,"1","Blood products, collected from a donor who was at risk for variant Creutzfeldt-Jakob disease (vCJD), were distributed.",10/18/2012,"10/18/2012",5/8/2013,"05/08/2013"
"Devices",64175,"Ongoing","Fresenius Medical Care Holdings, Inc.","Waltham","MA","US","Voluntary: Firm Initiated","Telephone","Nationwide Distribution.","Z-0799-2013","Class II","Fresenius Liberty Cycler Set Single Conn. Ext. DL. Part Number: 050-87216. Acute and chronic peritoneal dialysis. ","Lot 12BR08009",,"560 cases, totaling 5590 units","There is a small risk of a leak in Cycler Sets and if the Cycler Set is punctured, the dialysate may become contaminated potentially resulting in peritonitis. ",10/12/2012,"10/12/2012",2/20/2013,"02/20/2013"
"Biologics",64176,"Terminated","Our Lady Of The Lake Hospital Inc","Baton Rouge","LA","US","Voluntary: Firm Initiated","FAX","5 in Louisiana","B-1584-13","Class II","Red Blood Cells Leukocytes Reduced","W165712027965K, W165712027847W, W1657120268020, W1657120275793, W1657120243743, W165712024360F, W165712024396S, W165712024368, W1657120243663, W1657120243655, W1657120243647, W1657120243639, W165712027902D, W165712026691J, W1657120266228, W165712026191M, W1657120266164, W165712024260N, W1657120284020, W165712026586L",".","20 units","Blood products, collected from a potentially ineligible donor, were distributed. ",12/21/2012,"12/21/2012",6/19/2013,"06/19/2013"
"Biologics",64176,"Terminated","Our Lady Of The Lake Hospital Inc","Baton Rouge","LA","US","Voluntary: Firm Initiated","FAX","5 in Louisiana","B-1582-13","Class II","Red Blood Cells (Apheresis) Leukocytes Reduced","W1657120277545 (Part 1), W1657120277545 (Part 2), W165712023964C Bag 1, W165712023964C Bag 2",".","4 units","Blood products, collected from a potentially ineligible donor, were distributed. ",12/21/2012,"12/21/2012",6/19/2013,"06/19/2013"
"Biologics",64176,"Terminated","Our Lady Of The Lake Hospital Inc","Baton Rouge","LA","US","Voluntary: Firm Initiated","FAX","5 in Louisiana","B-1583-13","Class II","Fresh Frozen Plasma","W1657120266156, W165712026601I, W165712026599B, W165712024396S, W165712024395U, W165712024393Y, W1657120243903, W165712024368*, W1657120243671, W1657120243655, W1657120243647, W1657120250687, W165712024819E, W165712023827U, W165712027716H, W165712027712P, W165712027704P, W165712027700X, W1657120214666, W1657120213053, W165712021364I, W165712020867P, W165712019069A, W165712000939F, W165712019313Y, W165712018284C, W1657120182151, W165712018196C, W165712018100N, W165712018099E, W165712018097I, W1657120101824, W165712015088V, W165712016583M, W1657120149183, W165712007005W, W165712006336A, W165712006225O, W165712013834R, W165712013658R, W165712010491F, W165712010967C, W165712010925W, W165711028973L, W165712010427V, W1657120104240, W165712008629Q, W165712007439H, W165712006880*, W165712005346I, W165712005429G, W165712004663C, W1657120046101, W165712004483K, W165712004307F, W1657120023997, W1657120023989, W165712002389B, W165712002383N, W165712002376L, W165712000189M, W1657120213205, W1657120195793, W165712022369T, W1657120189617, W165712025372S, W165712000927N, W1657120009008, W165712018308S, W1657120182868, W165712018171U, W165712018106B, W1657120106401, W165712010637B, W165712010563F, W1657120099697, W1657120099140, W165712009810G, W165712018318Q, W165712016555U, W165712007447H, W165712007446J, W165712007008Q, W165712007007S, W165712006981Q, W165712006963U, W1657120132181, W165712011854E, W165712006093G, W165712010960Q, W165712009948H, W1657120102616, W165712009811E, W1657120098340, W1657120100960, W1657120100864, W165712010243A, W165712010177Z, W1657120101664, W165712008483U, W165712008705Y, W165712007432V, W165712007391H, W1657120061938, W165712002380T, W165712013501W, W165712024191H, W1657120146114, W165712016584K, W165712018007H, W1657120182876, W165712016589A",".","112 units","Blood products, collected from a potentially ineligible donor, were distributed. ",12/21/2012,"12/21/2012",6/19/2013,"06/19/2013"
"Devices",64177,"Ongoing","Breg Inc","Carlsbad","CA","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution-USA (nationwide) and the countries of Australia, Singapore, Chile, Latvia.","Z-0803-2013","Class II","BREG Cold Therapy Combination Units containing Sterile Polar Pads. 02356 Rev M, PAD M/U XL STER, Mfg.Date: 112012. Model #s: 10903, 10703, 09101, 09111, 09131, 09731, 09611, 09621, and 09631. Local anesthetic effect.","Affected product will be identified by date of manufacture from January 2010 through October 2012. ",,"44,883 units","The recall was initiated because Breg has determined that some Sterile Polar Pads products manufactured from January 2010 to October 2012 may have sustained damage to the product packaging which may compromise product sterility assurance.",1/14/2013,"01/14/2013",2/20/2013,"02/20/2013"
"Devices",64177,"Ongoing","Breg Inc","Carlsbad","CA","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution-USA (nationwide) and the countries of Australia, Singapore, Chile, Latvia.","Z-0804-2013","Class II","BREG Sterile Polar Pads; 02356 Rev M, PAD M/U XL STER, Mfg.Date: 112012. Model #s: 02510, 09901, 02330, 02350, 02490, 02356, 02496, 02410. Local anesthetic effect.","Affected product will be identified by date of manufacture from January 2010 through October 2012 ",,"44,883 units","The recall was initiated because Breg has determined that some Sterile Polar Pads products manufactured from January 2010 to October 2012 may have sustained damage to the product packaging which may compromise product sterility assurance.",1/14/2013,"01/14/2013",2/20/2013,"02/20/2013"
"Devices",64178,"Ongoing","GE Healthcare, LLC","Waukesha","WI","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution-USA (nationwide) including the states of AL, AZ, CA, CO, CT, FL, GA, IL, IN, IA, KS, KY, ME, MD, MA, MN, MS,MO, NV, NH, NJ, NM, NY, NC, OH, OK, OR, PA, SC, TN, TX, UT , VA, WA, WV, WI and the countries of VENEZUELA, UNITED KINGDOM, TURKEY, THAILAND, TAIWAN, SPAIN, SAUDI ARABIA, RUSSIAN FEDERATION, PORTUGAL, POLAND, NORWAY, NIGERIA, NICARAGUA, MOROCCO, MALTA, LEBANON, KAZAKHSTAN, JAPAN, ITALY, INDONESIA, INDIA, HUNGARY, GREECE, FRANCE, EGYPT, CHINA, CANADA, BRAZIL, BELGIUM, and NEW ZEALAND.","Z-0947-2013","Class II","GE Healthcare Advantx, Innova2000, Innova3100, Innova4100, Innova2100IQ,Innova3100IQ, and Innova4100IQ equipped with Video Monitor Suspension model numbers 2236709, 2353620 ,2223039-2, and 2270677-2. For use in diagnostic and interventional angiographic procedures of human anatomy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ealthcare has recently become aware of a potential safety issue involving a locking nut which might loosen out of the overhead Video Monitor Suspension yoke affecting Advantx, Innova 2000, Innova 2100IQ, Innova 3100, Innova 3100IQ, Innova 4100, and Innova 4100IQ Cardiovascular X-ray imaging systems. ",1/21/2013,"01/21/2013",3/20/2013,"03/20/2013"
"Food",64179,"Ongoing","Nuera Trading Company Incorporated","San Leandro","CA","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","CA, WA, TX and NY","F-0968-2013","Class II","Dried Preserved Plum packaged in clear 4.4 lb (1904 g) plastic packages. The product comes in bulk form in a brown corrugated box with 10 x 4.4 lb packages. Net weight of one case is 44 lbs.. Product information is provided on the case with product name ''Dried Preserved Plum'' and Net Weight 44 lbs. (Product was destroyed and photos of product are not available). Distributed by Nuera Trading Company Inc., San Leandro, CA. Manufactured by Zi Jing Yuk Hin Enterprises, Guangdong, China.","No code information",,"~580 cartons (10 x 4.4lb packages per carton)","California Department of Public Health sampled Dried Plum Preserves in 4.4 lb packages and found it to contain lead at 1.5 and 1.6 ug/g.",1/15/2013,"01/15/2013",2/13/2013,"02/13/2013"
"Drugs",64180,"Ongoing","Lee Pharmaceuticals, Inc","South El Monte","CA","US","Voluntary: Firm Initiated","Letter","Nationwide","D-161-2013","Class II","12-Hour Sinus (oxymetazoline hydrochloride) Nasal Spray, 0.05%, 1 FL OZ (30 mL), labeled as a) 12 HOUR SINUS Nasal Spray, Best Choice, Proudly Distributed By: Valu Merchandisers, Co., Kansas City, MO 64111, UPC 0 70038 61226 1; b) Nasal Spray Sinus, Distributed by Discount Drug Mart, Medina, Ohio 44258, UPC 0 9335112623 9; c) sinus relief nasal spray, Distributed By DUANE reade, 440 Ninth Avenue, NY, NY 10001, UPC 6 39194 04551 3; d) 12 Hour Nasal Relief Sinus Nasal Spray, Distributed by: Lee Pharmaceuticals, South El Monte, CA 91733, UPC 0 23558 69230 5; e) Sinus Nasal Spray, Premier Value, Distributed By: Chain Drug Consortium, LLC, 2300 NW Corporate Blvd., Suite 115, Boca Raton, FL 33431, UPC 8 40986 01517 5, NDC 68016-0307-03; f) Nasal Relief Sinus Squeeze Spray, Distributed By Quality Choice, Novi, Michigan 48376-0995, UPC 6 35515 99012 8, NDC 63868-0062-30; g) sinus relief nasal spray, Distributed By: Rite Aid, 30 Hunter Lane, Camp Hill, PA 17011, UPC 0 11822 14576 3; h) Sinus Nasal Spray, Distributed by: Select Brand Distributors, Pine Bluff, AR 71603, UPC 015127 02305 4, NDC 15127-889-30.","Lot #: 2111 and 2114, Exp 04/14",,"32,460 bottles","Microbial Contamination of a Non-Sterile Products: 12-Hour Sinus Nasal Spray under various labeling are being recalled due to microbial contamination identified during testing.",12/21/2012,"12/21/2012",2/20/2013,"02/20/2013"
"Food",64181,"Ongoing","Pamela's Products, Inc.","Ukiah","CA","US","Voluntary: Firm Initiated","Letter","36 distributors nationwide in AZ, CA, CO, CT, FL, GA, IA, IL, IN, MD, NJ, NJ, NV, OR, PA, SC, TN, TX, WA.","F-0986-2013","Class II","Pamela's Chocolate Chunk Cookie Mix; Gluten Free, Wheat Free, Non Dairy 13.9 oz. package. UPC 93709-30050 Pamela's Products, Ukiah, CA 95482","Product Code 93709-30050, Best Before Oct 7, 2013.",,"1709 cases","Firm received complaints for on four (4) products which may contain glass or plastic fragments.",1/19/2013,"01/19/2013",2/20/2013,"02/20/2013"
"Food",64181,"Ongoing","Pamela's Products, Inc.","Ukiah","CA","US","Voluntary: Firm Initiated","Letter","36 distributors nationwide in AZ, CA, CO, CT, FL, GA, IA, IL, IN, MD, NJ, NJ, NV, OR, PA, SC, TN, TX, WA.","F-0985-2013","Class II","Pamela's Baking and Pancake Mix; Gluten Free, Wheat Free 24 oz package. UPC 93709-30010 Pamela's Products, Ukiah, CA 95482","Product Code 93709-30010, Best Before Sep 26, 2013.",,"2 229 cases","Firm received complaints for on four (4) products which may contain glass or plastic fragments.",1/19/2013,"01/19/2013",2/20/2013,"02/20/2013"
"Food",64181,"Ongoing","Pamela's Products, Inc.","Ukiah","CA","US","Voluntary: Firm Initiated","Letter","36 distributors nationwide in AZ, CA, CO, CT, FL, GA, IA, IL, IN, MD, NJ, NJ, NV, OR, PA, SC, TN, TX, WA.","F-0987-2013","Class II","Pamela's Chocolate Cake Mix; Gluten Free, Wheat Free, Non Dairy 21 oz. package. UPC 93709-30040 Pamela's Products, Ukiah, CA 95482","Product Code 93709-30040, Best Before Sept 11, 2013; Sep 19, 2013 and Oct 4, 2013.",,"967 cases BB 9/11/13; 1939 cases BB 9/19/13; 1694 cases BB 10/4/13","Firm received complaints for on four (4) products which may contain glass or plastic fragments.",1/19/2013,"01/19/2013",2/20/2013,"02/20/2013"
"Food",64181,"Ongoing","Pamela's Products, Inc.","Ukiah","CA","US","Voluntary: Firm Initiated","Letter","36 distributors nationwide in AZ, CA, CO, CT, FL, GA, IA, IL, IN, MD, NJ, NJ, NV, OR, PA, SC, TN, TX, WA.","F-0988-2013","Class II","Pamela's Peanut Butter Chocolate Chip Cookies; Gluten Free 5.29 oz. package. UPC 93709-40180 Pamela's Products, Ukiah, CA 95482","Product Code 93709-40180, Best Before Apr 14, 2013. ",,"523 cases","Firm received complaints for on four (4) products which may contain glass or plastic fragments.",1/19/2013,"01/19/2013",2/20/2013,"02/20/2013"
"Drugs",64182,"Ongoing","Reumofan Plus USA","Springfield","PA","US","Voluntary: Firm Initiated","Letter","Nationwide through internet sales.","D-837-2013","Class I","Reumofan Plus, 30-count tablets per bottle, distriubted by Reumofan Plus USA, LLC and Reumofan USA, LLC, Springfield, PA, and manufactured by Riger Natural S.A., Mexico.","Lot #: 99515, Exp 09/2016",".","586 bottles","Marketed without an approved NDA/ANDA: Product may contain undeclared active pharmaceutical ingredients Diclofenac Sodium, Dexamethasone, and Methocarbamol.",1/4/2013,"01/04/2013",8/14/2013,"08/14/2013"
"Biologics",64183,"Terminated","BloodCenter of Wisconsin, Inc","Milwaukee","WI","US","Voluntary: Firm Initiated","FAX","Wisconsin","B-1084-13","Class II","Platelets Pheresis Leukocytes Reduced","W036310008862 Part 1; W036310008862 Part 2; ",,"2","Blood products, which were collected from a donor who lived in a malarial endemic area, were distributed. ",12/4/2012,"12/04/2012",5/8/2013,"05/08/2013"
"Biologics",64183,"Terminated","BloodCenter of Wisconsin, Inc","Milwaukee","WI","US","Voluntary: Firm Initiated","FAX","Wisconsin","B-1085-13","Class II","Red Blood Cells Leukocytes Reduced","W036309001612; W036309014482; ",,"2","Blood products, which were collected from a donor who lived in a malarial endemic area, were distributed. ",12/4/2012,"12/04/2012",5/8/2013,"05/08/2013"
"Food",64184,"Ongoing","United Natural Foods, Inc. - Greenwood","Greenwood","IN","US","Voluntary: Firm Initiated","Other","Customers are retail locations in 6 states: Illinois, Indiana, Kentucky, Michigan, Missouri, and Ohio.","F-0960-2013","Class I","Kinnikinnick Pie Crust (frozen), Weight: 290 g/10 oz, Qty/Pkg: 2, Product packaged in a cardboard box with printed label. UPC: 62013300600 9","Expiration date 2013-12-11",".","28 cases/6 packages per case","Kinnikinnick Foods, Inc. in Edmonton, Alberta Canada indicated that United Natural Foods Inc. distributors received pie crusts in association with their expanded recall/allergy alert issued 01/17/13. ",1/17/2013,"01/17/2013",2/6/2013,"02/06/2013"
"Devices",64185,"Ongoing","Integra LifeSciences Corp.","Plainsboro","NJ","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution - USA including AL, AR, AZ, CA, CO, CT, FL, GA, IL, IN, KY, MA, MD, MI, MN, MO, MS, NC, NE, NJ, NM, NY, OH, OK, OR, PA, TN, TX, UT, VA, WA & WI. Internationally to Belgium.","Z-0869-2013","Class II","MAYFIELD Composite Series Base Unit Standard, Model (A3101), Rx ONLY, Integra LifeScience Corporation, 4900 Charlemar Drive, Building A, Cincinnati, OH 45227 The MAYFIELD Base Units are intended to be used to support a patient during diagnostic examination and/or surgical procedures where a rigid support between surgical table and headrest, or skull clamp is necessary, positional freedom is required and where X-ray imaging modalities will be used.","Model # A3101 Base Units Serial No's: SB120016, SB120017, SB120019, SB120020, SB120021, SB120022, SB120023, SB120024, SB120025, SB120026, SB120027, SB120028, SB120029, SB120030, SB120031, SB120032, SB120134, SB120036, SB120037, SB120038, SB120040, SB120042, SB120043, SB120044, SB120045, SB120049, SB120050, SB120051, SB120052, SB120053, SB120054, SB120055, SB120056, SB120057, SB120058, SB120059, SB120060, SB120061, SB120062, SB120063, SB120064, SB120065, SB120066, SB120067, SB120068, SB120069, SB120070, SB120071, SB120072, SB120073, SB120074, SB120075, SB120076, SB120077, SB120078, SB120079, SB120080, SB120081, SB120082, SB120083, SB120084, SB120085, SB120086, SB120087, SB120088, SB120089, SB120090, SB120091, SB120092, SB120093, SB120094, SB120095, SB120096, SB120097, SB120098, SB120099, SB120100, SB120107, SB120108, SB120109, SB120111, SB120112, SB120113, SB120114, SB120115, SB120116, SB120117, SB120118, SB120119, SB120120, SB120121, SB120122, SB120129, SB120131, SB120138 & SB120141.",".","96 units","Integra determined there is a possibility that the Base Units may break during use.",12/21/2012,"12/21/2012",2/27/2013,"02/27/2013"
"Drugs",64186,"Ongoing","Mylan Pharmaceuticals Inc.","Morgantown","WV","US","Voluntary: Firm Initiated","Letter","Nationwide","D-147-2013","Class II","Lansoprazole Delayed-release Capsules, USP, 30 mg, 500-count capsules per bottle, Rx only, Manufactured for: Mylan Pharmaceuticals Inc., Morgantown, WV 26505 U.S.A., Made in India, NDC 0378-8030-05.","Lot #: 1110829, Exp 05/14",,"1,894 bottles","Presence of Foreign Tablets/Capsules: Bottles of lansoprazole 30 mg delayed-release capsules may contain topiramate 100 mg tablets.",1/30/2013,"01/30/2013",2/13/2013,"02/13/2013"
"Food",64187,"Ongoing","Bimbo Bakeries Usa","Horsham","PA","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Products were to distributed to grocery outlets within the US in AL, FL, GA, LA, MS, NC, SC, and TN.","F-1004-2013","Class II","Weight Watchers 6 Original Bagels, 15 oz packages ","Best buy dates (month and day) ''JAN 18'' to and including ''JAN 27'' found on the lock tab bag closures in the following states: AL, FL, GA, NC, SC and TN.",".","4,032 packages","The firm found metal fragments in two packages of product.",1/16/2013,"01/16/2013",2/27/2013,"02/27/2013"
"Food",64187,"Ongoing","Bimbo Bakeries Usa","Horsham","PA","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Products were to distributed to grocery outlets within the US in AL, FL, GA, LA, MS, NC, SC, and TN.","F-1003-2013","Class II","Publix Premium Bagels, 20 oz packages; ORIGINAL, MULTI-GRAIN, and CINNAMON RAISIN SWIRL varieties.","Best buy dates (month and day) ''JAN 18'' to and including ''JAN 27'' found on the lock tab bag closures in the following states: AL, FL, SC and TN.",".","34,020 packages","The firm found metal fragments in two packages of product.",1/16/2013,"01/16/2013",2/27/2013,"02/27/2013"
"Food",64187,"Ongoing","Bimbo Bakeries Usa","Horsham","PA","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Products were to distributed to grocery outlets within the US in AL, FL, GA, LA, MS, NC, SC, and TN.","F-1002-2013","Class II","Sara Lee Deluxe Bagels, 20 oz packages; BLUEBERRY, PLAIN, CINNAMON RAISIN,and HONEY WHEAT varieties.","Best buy dates (month and day) ''JAN 18'' to and including ''JAN 27'' found on the lock tab bag closures in the following states: AL, FL, GA, LA, MS, NC, SC and TN.",".","57,492 packages","The firm found metal fragments in two packages of product.",1/16/2013,"01/16/2013",2/27/2013,"02/27/2013"
"Food",64187,"Ongoing","Bimbo Bakeries Usa","Horsham","PA","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Products were to distributed to grocery outlets within the US in AL, FL, GA, LA, MS, NC, SC, and TN.","F-1001-2013","Class II","Thomas' Bagels, 1 lb 4 oz packages; EVERYTHING, ONION, BLUEBERRY, PLAIN, CINNAMON RAISIN, HEARTY GRAINS 100% WHOLE WHEAT, CINNAMON SWIRL and HONEY WHEAT varieties.","Best buy dates (month and day) ''JAN 18'' to and including ''JAN 27'' found on the lock tab bag closures in the following states: AL, FL, GA and TN.",".","418,356 packages","The firm found metal fragments in two packages of product.",1/16/2013,"01/16/2013",2/27/2013,"02/27/2013"
"Drugs",64188,"Ongoing","TG United, Inc.","Brooksville","FL","US","Voluntary: Firm Initiated","Letter","FL, MS, SC, LA and TX","D-505-2013","Class II","AMBI 25DPH/7.5PEH, Antihistamine, Nasal Decongestant, Fruit Candy Flavor, 16 fl oz. bottle, OTC, Manufactured for: AMBI Pharmaceuticals, Brooksville, FL 34604, NDC 66870-0226-16","Lot # 12DQ005, Exp. 03/14.",".","352 - 16 ounce bottles","CGMP Deviations: Products are underdosed or have an incorrect dosage regime. ",1/30/2013,"01/30/2013",6/12/2013,"06/12/2013"
"Drugs",64188,"Ongoing","TG United, Inc.","Brooksville","FL","US","Voluntary: Firm Initiated","Letter","FL, MS, SC, LA and TX","D-533-2013","Class II","CPM / PSE Drops, Antihistamine, Nasal Decongestant, 1 fl oz. bottle, OTC, Manufactured for: Trigen Laboratories, Sayreville, NJ,08872, NDC 13811-071-30","Lot# 11GQ003 Exp 06/13.",".","6551 30 mL bottles","CGMP Deviations: Products are underdosed or have an incorrect dosage regime. ",1/30/2013,"01/30/2013",6/12/2013,"06/12/2013"
"Drugs",64188,"Ongoing","TG United, Inc.","Brooksville","FL","US","Voluntary: Firm Initiated","Letter","FL, MS, SC, LA and TX","D-509-2013","Class II","AMBI 2CPM/15DM/5PEH, Antihistamine, Nasal Decongestant, Fruit Candy Flavor, 16 fl oz. bottle, OTC, Manufactured for: AMBI Pharmaceuticals, Brooksville, FL 34604, NDC 66870-0228-16.","Lot # 12DQ004, Exp. 03/14.",".","355 - 16 ounce bottles","CGMP Deviations: Products are underdosed or have an incorrect dosage regime. ",1/30/2013,"01/30/2013",6/12/2013,"06/12/2013"
"Drugs",64188,"Ongoing","TG United, Inc.","Brooksville","FL","US","Voluntary: Firm Initiated","Letter","FL, MS, SC, LA and TX","D-503-2013","Class II","AMBI 15DM/100GFN/5PEH, Antitussive, Expectorant, Nasal Decongestant, Grape Flavor, 4 fl oz. bottle, OTC, Manufactured for: AMBI Pharmaceuticals, Brooksville, FL 34604, NDC 66870-0200-04","Lot # 12HQ002 Exp. 07/14.",".","1398 - 4 ounce bottles","CGMP Deviations: Products are underdosed or have an incorrect dosage regime. ",1/30/2013,"01/30/2013",6/12/2013,"06/12/2013"
"Drugs",64188,"Ongoing","TG United, Inc.","Brooksville","FL","US","Voluntary: Firm Initiated","Letter","FL, MS, SC, LA and TX","D-511-2013","Class II","AMBI 3BRM/30DM/50PSE, Antihistamine, Cough Suppressant, Nasal Decongestant, Berry Vanilla Flavor, 16 fl oz. bottle, OTC, Manufactured for: AMBI Pharmaceuticals, Brooksville, FL 34604, NDC 66870-0229-16","Lot # 12HQ004, Exp. 07/14.",".","348 - 16 ounce bottles","CGMP Deviations: Products are underdosed or have an incorrect dosage regime. ",1/30/2013,"01/30/2013",6/12/2013,"06/12/2013"
"Drugs",64188,"Ongoing","TG United, Inc.","Brooksville","FL","US","Voluntary: Firm Initiated","Letter","FL, MS, SC, LA and TX","D-536-2013","Class II","Mesehist WC, Antihistamine, Antitussive, Decongestant, 16 fl oz. bottle, OTC, Manufactured for: Trigen Laboratories, Sayreville, NJ,08872, NDC 13811-0075-16","Lot# 11DQ001 Exp 03/13; Lot# 11MQ010 Exp. 11/13.",".","4,884 - 16 ounce bottles","CGMP Deviations: Products are underdosed or have an incorrect dosage regime. ",1/30/2013,"01/30/2013",6/12/2013,"06/12/2013"
"Drugs",64188,"Ongoing","TG United, Inc.","Brooksville","FL","US","Voluntary: Firm Initiated","Letter","FL, MS, SC, LA and TX","D-532-2013","Class II","TG 40PSE/400GFN Tablets, 1000 count bottle, OTC Manufactured by: TG United, Inc. Brooksville, FL 34604 NDC 29273-0706-10","Lot# 11A006 Exp 12/12; Lot# 11A007 Exp 12/12; Lot# 11G004 Exp 06/14; Lot# 11G005 Exp 06/14; Lot# 12C004 Exp 02/14; Lot# 12F007 Exp 05/14; Lot# 12F008 Exp.05/14; Lot #12F009 Exp. 05/14; Lot# 12G005 Exp 06/14. ",".","386 - 1000-count bottles ","CGMP Deviations: Products are underdosed or have an incorrect dosage regime. ",1/30/2013,"01/30/2013",6/12/2013,"06/12/2013"
"Drugs",64188,"Ongoing","TG United, Inc.","Brooksville","FL","US","Voluntary: Firm Initiated","Letter","FL, MS, SC, LA and TX","D-515-2013","Class II","ED A-HIST TABLETS, Antihistamine, Nasal Decongestant, 100 count bottle, OTC, Manufactured for: Edwards Pharmaceuticals Inc., Ripley, MS 38663, NDC 0485-0154-01","Lot# 11L008 Exp. 10/13; Lot# 12A001 Exp. 12/13; Lot# 12A002 Exp. 12/13; Lot# 12A006 Exp. 12/13; Lot#12A006 Exp. 12/13; Lot# 12A007 Exp. 12/13; Lot#12D013 Exp. 03/14; Lot# 12F002 Exp. 05/14; Lot# 12H006 Exp.07/14; Lot# 12J001 Exp. 08/14; Lot# 12J001 Exp. 08/14; Lot# 12K005 Exp. 09/14; Lot #12M002 Exp. 11/14; Lot# 12M003 Exp. 11/14. ",".","242,470","CGMP Deviations: Products are underdosed or have an incorrect dosage regime. ",1/30/2013,"01/30/2013",6/12/2013,"06/12/2013"
"Drugs",64188,"Ongoing","TG United, Inc.","Brooksville","FL","US","Voluntary: Firm Initiated","Letter","FL, MS, SC, LA and TX","D-542-2013","Class II","Trigofen DM Drops, Antihistamine,Cough Suppressant, Decongestant, , 1 fl oz. bottle, OTC, Manufactured for: Trigen Laboratories, Sayreville, NJ,08872, NDC 13811-0082-30","Lot# 11EQ008 Exp 04/13; Lot# 11HQ003 Exp. 07/13; Lot# 12JQ007 Exp. 08/14. ",".","40,149 - 30 mL bottles. ","CGMP Deviations: Products are underdosed or have an incorrect dosage regime. ",1/30/2013,"01/30/2013",6/12/2013,"06/12/2013"
"Drugs",64188,"Ongoing","TG United, Inc.","Brooksville","FL","US","Voluntary: Firm Initiated","Letter","FL, MS, SC, LA and TX","D-539-2013","Class II","TL-Hist PD Drops, Antihistamine, Nasal Decongestant,1 fl oz. bottle, OTC, Manufactured for: Trigen Laboratories, Sayreville, NJ,08872, NDC 13811-083-30","Lot# 12GQ003 Exp 06/14.",".","13,031 30 mL bottles. ","CGMP Deviations: Products are underdosed or have an incorrect dosage regime. ",1/30/2013,"01/30/2013",6/12/2013,"06/12/2013"
"Drugs",64188,"Ongoing","TG United, Inc.","Brooksville","FL","US","Voluntary: Firm Initiated","Letter","FL, MS, SC, LA and TX","D-518-2013","Class II","Dallergy CHEWABLE TABLETS, Antihistamine, Nasal Decongestant, 100 count bottle, OTC, Manufactured for: Laser Pharmaceuticals, LLC, Greenville, SC 29615, NDC 16477-152-01","Lot# 12B001 Exp. 01/14; Lot# 12B001 Exp. 01/14; Lot# 12B002 Exp 01/14; Lot# 12F013 Exp. 05/2014; Lot# 12F013 Exp. 05/2014.",".","8296 bottles - 100-count and 153,028 Bulk tablets","CGMP Deviations: Products are underdosed or have an incorrect dosage regime. ",1/30/2013,"01/30/2013",6/12/2013,"06/12/2013"
"Drugs",64188,"Ongoing","TG United, Inc.","Brooksville","FL","US","Voluntary: Firm Initiated","Letter","FL, MS, SC, LA and TX","D-529-2013","Class II","Poly Hist Forte, Nasal Decongestant, Antihistamine, 100 count bottle, OTC, Manufactured for: Poly Pharmaceuticals, Quitman, MS 39355 NDC 50991-210-01","Lot# 12L005 Exp 10/14.",".","330158 Bulk tablets. ","CGMP Deviations: Products are underdosed or have an incorrect dosage regime. ",1/30/2013,"01/30/2013",6/12/2013,"06/12/2013"
"Drugs",64188,"Ongoing","TG United, Inc.","Brooksville","FL","US","Voluntary: Firm Initiated","Letter","FL, MS, SC, LA and TX","D-534-2013","Class II","CPM / PSE DM Drops, Antihistamine, Cough Suppressant Decongestant, 1 fl oz. bottle, OTC, Manufactured for: Trigen Laboratories, Sayreville, NJ,08872 NDC 13811-072-30","Lot# 11EQ007 Exp 04/13; Lot# 12BQ001 Exp. 01/14..",".","26,315 - 30 mL bottles.","CGMP Deviations: Products are underdosed or have an incorrect dosage regime. ",1/30/2013,"01/30/2013",6/12/2013,"06/12/2013"
"Drugs",64188,"Ongoing","TG United, Inc.","Brooksville","FL","US","Voluntary: Firm Initiated","Letter","FL, MS, SC, LA and TX","D-524-2013","Class II","BroveX PSE, Antihistamine, Nasal Decongestant, 100 count bottle, OTC, Manufactured for: Pernix Therapeutics, Gonzales, LA 70737 NDC 58605-440-01","Lot# 11A001 Exp. 12/12; Lot# 11L002 Exp. 10/13; Lot # 12K007 Exp. 09/14. ",".","10,036 bottles - 100-count tablets","CGMP Deviations: Products are underdosed or have an incorrect dosage regime. ",1/30/2013,"01/30/2013",6/12/2013,"06/12/2013"
"Drugs",64188,"Ongoing","TG United, Inc.","Brooksville","FL","US","Voluntary: Firm Initiated","Letter","FL, MS, SC, LA and TX","D-541-2013","Class II","Trigofen Drops, Antihistamine, Decongestant,1 fl oz. bottle, OTC, Manufactured for: Trigen Laboratories, Sayreville, NJ, 08872, NDC 13811-0081-30","Lot# 11EQ010 Exp 04/13; Lot# 12AQ001 Exp. 12/13; Lot# 12JQ006 Exp. 08/14. ",".","39,403 - 30 mL bottles","CGMP Deviations: Products are underdosed or have an incorrect dosage regime. ",1/30/2013,"01/30/2013",6/12/2013,"06/12/2013"
"Drugs",64188,"Ongoing","TG United, Inc.","Brooksville","FL","US","Voluntary: Firm Initiated","Letter","FL, MS, SC, LA and TX","D-523-2013","Class II","Maxifed-G, Expectorant, Nasal Decongestant, 100 count bottle, OTC, Manufactured for: MCR American Pharmaceuticals Inc. Brooksville, FL 34604, NDC 58605-0408-01","Lot# 11G006 Exp. 06/13; Lot# 11K001 Exp. 09/13; Lot # 11K001 Exp. 09/13; Lot# 12C009 Exp. 02/14.",".","1623 bottles of 100-count tablets.","CGMP Deviations: Products are underdosed or have an incorrect dosage regime. ",1/30/2013,"01/30/2013",6/12/2013,"06/12/2013"
"Drugs",64188,"Ongoing","TG United, Inc.","Brooksville","FL","US","Voluntary: Firm Initiated","Letter","FL, MS, SC, LA and TX","D-531-2013","Class II","Poly-Vent IR, Poly-Vent DM Tablets, Expectorant, Nasal Decongestant, 60 count bottle, OTC, Distributed by: Poly Pharmaceuticals, Quitman, MS 39355, NDC 50991-561-60","Lot# 11F003 Exp 05/13; Lot# 11M007 Exp 11/13; Lot# 12J002 Exp 08/14. ",".","978,092 Bulk Tablets","CGMP Deviations: Products are underdosed or have an incorrect dosage regime. ",1/30/2013,"01/30/2013",6/12/2013,"06/12/2013"
"Drugs",64188,"Ongoing","TG United, Inc.","Brooksville","FL","US","Voluntary: Firm Initiated","Letter","FL, MS, SC, LA and TX","D-525-2013","Class II","BroveX PSE DM, Antihistamine, Cough Suppressant, Decongestant, 100 count bottle, OTC, Manufactured for: Pernix Therapeutics, Gonzales, LA 70737 NDC 58605-441-01","Lot# 11A002 Exp. 12/12; Lot# 11A003 Exp. 12/12; Lot # 11A004 Exp. 12/12; Lot# 11A005 Exp. 12/12; Lot# 11L003 Exp. 10/13.",".","16,836 bottles - 100-count.","CGMP Deviations: Products are underdosed or have an incorrect dosage regime. ",1/30/2013,"01/30/2013",6/12/2013,"06/12/2013"
"Drugs",64188,"Ongoing","TG United, Inc.","Brooksville","FL","US","Voluntary: Firm Initiated","Letter","FL, MS, SC, LA and TX","D-540-2013","Class II","Tri-Dex PE, Antihistamine, Antitussive, Nasal Decongestant, 16 fl oz. bottle, OTC, Manufactured for: Trigen Laboratories, Sayreville, NJ,08872, NDC 13811-088-16","Lot# 11FQ004 Exp 05/13; Lot# 11KQ001 Exp. 09/13; Lot# 11KQ002 Exp. 09/13; Lot#11KQ003 Exp. 09/13; Lot# 12HQ010 Exp. 07/14. ",".","12,198 - 16 ounce bottles. ","CGMP Deviations: Products are underdosed or have an incorrect dosage regime. ",1/30/2013,"01/30/2013",6/12/2013,"06/12/2013"
"Drugs",64188,"Ongoing","TG United, Inc.","Brooksville","FL","US","Voluntary: Firm Initiated","Letter","FL, MS, SC, LA and TX","D-514-2013","Class II","Ryddex G Tablets, Decongestant, Expectorant, 100 count bottle, OTC, Centurion Labs, LLC 657 Hwy 40 South, Ste B, Richland, MS 39218, NDC 23359-024-10","Lot # 11E002 Exp. 04/2013.",".","2957 bottles 100-count tablets","CGMP Deviations: Products are underdosed or have an incorrect dosage regime. ",1/30/2013,"01/30/2013",6/12/2013,"06/12/2013"
"Drugs",64188,"Ongoing","TG United, Inc.","Brooksville","FL","US","Voluntary: Firm Initiated","Letter","FL, MS, SC, LA and TX","D-520-2013","Class II","Cardec Drops,Antihistamine, Nasal Decongestant, 1 fl oz. bottle, OTC, Manufactured for: Macoven Pharmaceuticals, Magnolia, TX 77354 NDC 44183-604-30","Lot# 11DQ009 Exp. 03/13; Lot# 11JQ002 Exp. 08/13.",".","26,536 bottles - 30 mL","CGMP Deviations: Products are underdosed or have an incorrect dosage regime. ",1/30/2013,"01/30/2013",6/12/2013,"06/12/2013"
"Drugs",64188,"Ongoing","TG United, Inc.","Brooksville","FL","US","Voluntary: Firm Initiated","Letter","FL, MS, SC, LA and TX","D-527-2013","Class II","BroveX PSB DM LIQUID, Antihistamine, Decongestant, a) 16 fl oz. bottle, OTC, NDC 58605-151-01 b) 20 ml NDC 58605-151-02, Manufactured for: Pernix Therapeutics, Gonzales, LA 70737 ","Lot# 11AQ004 Exp. 12/12; Lot# 11AQ005 Exp. 12/12; Lot # 11AQ006 Exp. 12/12; Lot# 11AQ007 Exp. 12/12; Lot # 11BQ012 Exp. 01/13; Lot# 11LQ003 Exp. 10/13; Lot# 11LQ004 Exp. 10/13; Lot# 11LQ005 Exp 10/13; Lot# 11LQ006 Exp. 10/2013. ",".","19,728 bottles - 20 mL and 20,016 bottles - 16 ounce.","CGMP Deviations: Products are underdosed or have an incorrect dosage regime. ",1/30/2013,"01/30/2013",6/12/2013,"06/12/2013"
"Drugs",64188,"Ongoing","TG United, Inc.","Brooksville","FL","US","Voluntary: Firm Initiated","Letter","FL, MS, SC, LA and TX","D-545-2013","Class II","ZoDen DM Drops, Antihistamine,Cough Suppressant, Decongestant, , 1 fl oz. bottle, OTC, Manufactured for: Trigen Laboratories, Sayreville, NJ,08872, NDC 13811-0080-30","Lot# 11EQ009 Exp 04/13; Lot# 12AQ004 Exp. 12/13; Lot# 12KQ001 Exp. 09/14.",".","39,801 - 30 mL bottles. ","CGMP Deviations: Products are underdosed or have an incorrect dosage regime. ",1/30/2013,"01/30/2013",6/12/2013,"06/12/2013"
"Drugs",64188,"Ongoing","TG United, Inc.","Brooksville","FL","US","Voluntary: Firm Initiated","Letter","FL, MS, SC, LA and TX","D-512-2013","Class II","AMBI 40PSE/400GFN/20DM, Cough Suppressant, Expectorant, Nasal Decongestant, 100 count bottle, OTC, Manufactured for: AMBI Pharmaceuticals, Brooksville, FL 34604, NDC 66870-0409-01","Lot # 11D001 Exp. 03/13; Lot # 11D002 Exp. 03/13; Lot#11K003 Exp. 09/13; Lot# 12C010 Exp. 02/14.",".","1772 bottles per 100 count each","CGMP Deviations: Products are underdosed or have an incorrect dosage regime. ",1/30/2013,"01/30/2013",6/12/2013,"06/12/2013"
"Drugs",64188,"Ongoing","TG United, Inc.","Brooksville","FL","US","Voluntary: Firm Initiated","Letter","FL, MS, SC, LA and TX","D-508-2013","Class II","AMBI 25CPD/200GFN, Antitussive, Expectorant, Berry Vanilla Flavor, 16 fl oz. bottle, OTC, Manufactured for: AMBI Pharmaceuticals, Brooksville, FL 34604, NDC 66870-0221-16.","Lot # 12HQ007 Exp. 07/14.",".","348 - 16 ounce bottles.","CGMP Deviations: Products are underdosed or have an incorrect dosage regime. ",1/30/2013,"01/30/2013",6/12/2013,"06/12/2013"
"Drugs",64188,"Ongoing","TG United, Inc.","Brooksville","FL","US","Voluntary: Firm Initiated","Letter","FL, MS, SC, LA and TX","D-519-2013","Class II","BROMPHENIRAMINE/PSEUDOEPHEDRINE DM, LIQUID, Antihistamine, Cough Suppressant, Decongestant, 16 fl oz. bottle, OTC, Manufactured for: Macoven Pharmaceuticals, Magnolia, TX 77354 NDC 44183-311-16","Lot# 12B001 Exp. 01/14; Lot# 12B001 Exp. 01/14; Lot# 12B002 Exp 01/14; Lot# 12F013 Exp. 05/14; Lot# 12F013 Exp. 05/14.",".","22,721 - 16 ounce bottles ","CGMP Deviations: Products are underdosed or have an incorrect dosage regime. ",1/30/2013,"01/30/2013",6/12/2013,"06/12/2013"
"Drugs",64188,"Ongoing","TG United, Inc.","Brooksville","FL","US","Voluntary: Firm Initiated","Letter","FL, MS, SC, LA and TX","D-506-2013","Class II","AMBI 12.5 CPD/100GFN/30PSE, Antitussive, Expectorant, Nasal Decongestant, Raspberry Flavor, 16 fl oz. bottle, OTC, Manufactured for: AMBI Pharmaceuticals, Brooksville, FL 34604, NDC 66870-0223-16","Lot # 12HQ005, Exp. 07/14.",".","348 - 16 ounce bottles","CGMP Deviations: Products are underdosed or have an incorrect dosage regime. ",1/30/2013,"01/30/2013",6/12/2013,"06/12/2013"
"Drugs",64188,"Ongoing","TG United, Inc.","Brooksville","FL","US","Voluntary: Firm Initiated","Letter","FL, MS, SC, LA and TX","D-535-2013","Class II","Mesehist DM, Antihistamine, Antitussive, Decongestant, 16 fl oz. bottle, OTC, Manufactured for: Trigen Laboratories, Sayreville, NJ,08872 NDC 13811-0085-16","Lot# 11CQ010 Exp 02/13; Lot# 11EQ003 Exp. 04/13; Lot# 11FQ002 Exp. 05/13; Lot# 11FQ003 Exp. 05/13; Lot# 12HQ009 Exp. 07/14.",".","12,120 - 16 ounce bottles","CGMP Deviations: Products are underdosed or have an incorrect dosage regime. ",1/30/2013,"01/30/2013",6/12/2013,"06/12/2013"
"Drugs",64188,"Ongoing","TG United, Inc.","Brooksville","FL","US","Voluntary: Firm Initiated","Letter","FL, MS, SC, LA and TX","D-530-2013","Class II","Poly-Vent DM Tablets, Cough Suppressant, Expectorant, Nasal Decongestant, 60 count bottle, OTC, Distributed by: Poly Pharmaceuticals, Quitman, MS 39355 NDC 50991-309-60","Lot# 11F005 Exp 05/13; Lot# 11M008 Exp 11/13; Lot# 12J003 Exp 08/12. ",".","977,719 Bulk Tablets ","CGMP Deviations: Products are underdosed or have an incorrect dosage regime. ",1/30/2013,"01/30/2013",6/12/2013,"06/12/2013"
"Drugs",64188,"Ongoing","TG United, Inc.","Brooksville","FL","US","Voluntary: Firm Initiated","Letter","FL, MS, SC, LA and TX","D-513-2013","Class II","AMBI 40PSE/400GFN, 100 tablet bottle, OTC, Manufactured for: AMBI Pharmaceuticals, Brooksville, FL 34604, NDC 66870-0408-01","Lot # 12C007 Exp. 02/14; Lot # 12C008 Exp. 02/14.",".","886 bottles - 100-count tablets","CGMP Deviations: Products are underdosed or have an incorrect dosage regime. ",1/30/2013,"01/30/2013",6/12/2013,"06/12/2013"
"Drugs",64188,"Ongoing","TG United, Inc.","Brooksville","FL","US","Voluntary: Firm Initiated","Letter","FL, MS, SC, LA and TX","D-543-2013","Class II","Z-Dex Pediatric Drops, Cough Suppressant Decongestant, Expectorant 16 fl oz. bottle, OTC, Manufactured for: Trigen Laboratories, Sayreville, NJ,08872, NDC 13811-0001-30","Lot# 11DQ004 Exp 03/13.",".","12,988 - 30 mL bottles.","CGMP Deviations: Products are underdosed or have an incorrect dosage regime. ",1/30/2013,"01/30/2013",6/12/2013,"06/12/2013"
"Drugs",64188,"Ongoing","TG United, Inc.","Brooksville","FL","US","Voluntary: Firm Initiated","Letter","FL, MS, SC, LA and TX","D-538-2013","Class II","TL Hist DM, Antihistamine, Decongestant, Cough Suppressant, 16 fl oz. bottle, OTC, Manufactured for: Trigen Laboratories, Sayreville, NJ,08872, NDC 13811-068-16","Lot# 11CQ011 Exp 02/13; Lot# 11DQ007 Exp. 03/13; Lot# 11DQ008 Exp. 03/13; Lot# 11EQ002 Exp. 04/13; Lot # 11KQ004 Exp 09/13; Lot# 11KQ005 Exp. 09/13 ",".","98,202 16 ounce bottles. ","CGMP Deviations: Products are underdosed or have an incorrect dosage regime. ",1/30/2013,"01/30/2013",6/12/2013,"06/12/2013"
"Drugs",64188,"Ongoing","TG United, Inc.","Brooksville","FL","US","Voluntary: Firm Initiated","Letter","FL, MS, SC, LA and TX","D-528-2013","Class II","Lusair Liquid, 1 PINT bottle, OTC, Marketed by: Pernix Therapeutics, Gonzales, LA 70737 NDC 23359-017-16","Lot# 11AQ004 Exp. 12/12; Lot# 11AQ005 Exp. 12/12; Lot # 11AQ006 Exp. 12/12; Lot# 11AQ007 Exp. 12/12; Lot # 11BQ012 - 19728 20 mL, Exp. 01/13; Lot# 11LQ003 Exp. 10/13; Lot# 11LQ004 Exp. 10/13; Lot# 11LQ005 Exp 10/13; Lot# 11LQ006 Exp. 10/13. ",".",,"CGMP Deviations: Products are underdosed or have an incorrect dosage regime. ",1/30/2013,"01/30/2013",6/12/2013,"06/12/2013"
"Drugs",64188,"Ongoing","TG United, Inc.","Brooksville","FL","US","Voluntary: Firm Initiated","Letter","FL, MS, SC, LA and TX","D-510-2013","Class II","AMBI 3BRM/15DM/30PSE, Antihistamine, Cough Suppressant, Nasal Decongestant, Berry Vanilla Flavor, 16 fl oz. bottle, OTC, Manufactured for: AMBI Pharmaceuticals, Brooksville, FL 34604, NDC 66870-0230-16.","Lot # 12HQ003, Exp. 07/14.",".","348 - 16 ounce bottles","CGMP Deviations: Products are underdosed or have an incorrect dosage regime. ",1/30/2013,"01/30/2013",6/12/2013,"06/12/2013"
"Drugs",64188,"Ongoing","TG United, Inc.","Brooksville","FL","US","Voluntary: Firm Initiated","Letter","FL, MS, SC, LA and TX","D-504-2013","Class II","AMBI 20DM100GFN10PEH, Antitussive, Expectorant, Nasal Decongestant, Grape Flavor, 16 fl oz. bottle, OTC, Manufactured for: AMBI Pharmaceuticals, Brooksville, FL 34604, NDC 66870-0200-16","Lot # 12DQ002, Exp. 03/14.",".","348 - 16 ounce bottles.","CGMP Deviations: Products are underdosed or have an incorrect dosage regime. ",1/30/2013,"01/30/2013",6/12/2013,"06/12/2013"
"Drugs",64188,"Ongoing","TG United, Inc.","Brooksville","FL","US","Voluntary: Firm Initiated","Letter","FL, MS, SC, LA and TX","D-526-2013","Class II","BroveX PSB LIQUID, Antihistamine, Decongestant, a) 16 fl oz. bottle, OTC, NDC 58605-150-01 b) 20 ml NDC 58605-150-02, Manufactured for: Pernix Therapeutics, Gonzales, LA 70737 ","Lot# 11CQ005 Exp. 02/13; Lot# 11LQ002 Exp. 10/13; Lot # 12CQ005-Exp. 02/14; Lot# 12EQ003 Exp. 04/14; Lot# 12EQ004 Exp. 04/14; Lot# 12JQ004 Exp. 08/14. ",".","57,936 bottles - 20 mL and 7,476 bottles -16 ounce","CGMP Deviations: Products are underdosed or have an incorrect dosage regime. ",1/30/2013,"01/30/2013",6/12/2013,"06/12/2013"
"Drugs",64188,"Ongoing","TG United, Inc.","Brooksville","FL","US","Voluntary: Firm Initiated","Letter","FL, MS, SC, LA and TX","D-546-2013","Class II","ZoDen PD, Antihistamine, Nasal Decongestant,16 fl oz. bottle, OTC, Manufactured for: Trigen Laboratories, Sayreville, NJ,08872 NDC 13811-0073-16","Lot# 11CQ012 Exp 02/13; Lot# 12GQ002 Exp. 06/14. ",".","4811 - 16 ounce bottles.","CGMP Deviations: Products are underdosed or have an incorrect dosage regime. ",1/30/2013,"01/30/2013",6/12/2013,"06/12/2013"
"Drugs",64188,"Ongoing","TG United, Inc.","Brooksville","FL","US","Voluntary: Firm Initiated","Letter","FL, MS, SC, LA and TX","D-544-2013","Class II","Z-Dex Syrup, Decongestant, Antitussive, Expectorant, 16 fl oz. bottle, OTC, Manufactured for: Trigen Laboratories, Sayreville, NJ,08872, NDC 13811-0002-16","Lot# 11EQ004 Exp 04/13.",".","2388 - 16 ounce bottles. ","CGMP Deviations: Products are underdosed or have an incorrect dosage regime. ",1/30/2013,"01/30/2013",6/12/2013,"06/12/2013"
"Drugs",64188,"Ongoing","TG United, Inc.","Brooksville","FL","US","Voluntary: Firm Initiated","Letter","FL, MS, SC, LA and TX","D-521-2013","Class II","Cardec DM Drops, Decongestant, Antihistamine, Antitussive, 1 fl oz. bottle, OTC, Manufactured for: Macoven Pharmaceuticals, Magnolia, TX 77354 NDC 44183-550-30","Lot# 11CQ001 Exp. 02/13; Lot# 11CQ009 Exp. 02/13; Lot # 11JQ003 Exp. 08/13; Lot# 11JQ004 Exp. 08/23; Lot# 11MQ002 Exp. 11/13.",".","216,838 bottles - 30 mL","CGMP Deviations: Products are underdosed or have an incorrect dosage regime. ",1/30/2013,"01/30/2013",6/12/2013,"06/12/2013"
"Drugs",64188,"Ongoing","TG United, Inc.","Brooksville","FL","US","Voluntary: Firm Initiated","Letter","FL, MS, SC, LA and TX","D-537-2013","Class II","TL-DEX DM, Cough Suppressant Decongestant, Expectorant 16 fl oz. bottle, OTC, Manufactured for: Trigen Laboratories, Sayreville, NJ,08872, NDC 13811-067-16","Lot# 11AQ003 Exp 12/12.",".","2532 - 16 ounce bottles. ","CGMP Deviations: Products are underdosed or have an incorrect dosage regime. ",1/30/2013,"01/30/2013",6/12/2013,"06/12/2013"
"Drugs",64188,"Ongoing","TG United, Inc.","Brooksville","FL","US","Voluntary: Firm Initiated","Letter","FL, MS, SC, LA and TX","D-507-2013","Class II","AMBI 12.5 CPD/120GFN/5PEH, Cough Suppressant, Expectorant, Nasal Decongestant, Berry Vanilla Flavor, 16 fl oz. bottle, OTC, Manufactured for: AMBI Pharmaceuticals, Brooksville, FL 34604, NDC 66870-0224-16 ","Lot # 12HQ006, Exp. 07/14.",".","348 - 16 ounce bottles","CGMP Deviations: Products are underdosed or have an incorrect dosage regime. ",1/30/2013,"01/30/2013",6/12/2013,"06/12/2013"
"Drugs",64188,"Ongoing","TG United, Inc.","Brooksville","FL","US","Voluntary: Firm Initiated","Letter","FL, MS, SC, LA and TX","D-522-2013","Class II","Maxifed DM, Expectorant, Nasal Decongestant, 100 count bottle, OTC, Manufactured for: MCR American Pharmaceuticals Inc. , Brooksville, FL 34604, NDC 58605-0409-01 ","Lot# 11B002 Exp. 01/13; Lot# 11B003 Exp. 01/13; Lot # 11G007 Exp. 06/13; Lot# 11J002 Exp. 08/13; Lot# 11K002 Exp. 09/13; Lot# 12C011 Exp. 02/14.",".","2706 bottles of 100 count tablets","CGMP Deviations: Products are underdosed or have an incorrect dosage regime. ",1/30/2013,"01/30/2013",6/12/2013,"06/12/2013"
"Drugs",64188,"Ongoing","TG United, Inc.","Brooksville","FL","US","Voluntary: Firm Initiated","Letter","FL, MS, SC, LA and TX","D-517-2013","Class II","Dallergy TABLETS, Antihistamine, Nasal Decongestant, 100 count bottle, OTC, Manufactured for: Laser Pharmaceuticals, LLC, Greenville, SC 29615, NDC 16477-160-01","Lot# 11L006 Exp. 10/13; Lot# 11L006 Exp. 10/13; Lot# 12B003 Exp 01/14; Lot# 12B003 Exp. 01/14; Lot#12D005 Exp. 03/14; Lot# 12D005 Exp. 03/14; Lot# 12H001 Exp. 07/14. ",".","31,739 bottles 100-count; 842,617 Bulk tablet bottles","CGMP Deviations: Products are underdosed or have an incorrect dosage regime. ",1/30/2013,"01/30/2013",6/12/2013,"06/12/2013"
"Drugs",64188,"Ongoing","TG United, Inc.","Brooksville","FL","US","Voluntary: Firm Initiated","Letter","FL, MS, SC, LA and TX","D-516-2013","Class II","NoHist TABLETS, Antihistamine, Nasal Decongestant, 100 count bottle, OTC, Distributed by: Larken Laboratories, Inc., Canton, MS 39046, NDC 68047-173-01 ","Lot# 11K010 Exp. 09/13. ",".","4824 bottles - 100-count ","CGMP Deviations: Products are underdosed or have an incorrect dosage regime. ",1/30/2013,"01/30/2013",6/12/2013,"06/12/2013"
"Devices",64189,"Ongoing","GE Healthcare, LLC","Waukesha","WI","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution -- USA in the states of AR ,CA, CO, DC, FL, GA, HI, ID, IL, IN, KS, MA, MD, MI, MO, MS, NC, NE, NJ, NY, NV, OH, PA, TN, TX, VA, WA, WI, and WV, and the countries of Arab Emirates, Albania, Australia, Belgium, Brazil, Canada, Chile, China, Croatia, Czech., Denmark, Ecuador, Estonia, Finland, France, Germany, Hungary, Italy ,Korea, Kurdistan, Lebanon, Macedonia, Malaysia, Mexico, Norway, Oman, Poland, Russia, San Salvador, Saudi Arabia, Singapore, South Africa, Sweden, Turkey, Uruguay, Venezuela, and United Kingdom.","Z-1051-2013","Class I","Giraffe OmniBed and Giraffe Incubator p/n 6600-0723-700 (rev A and B) labeled in part: ***GE Healthcare 8880 Gorman Road Laurel, MD 20723 U.S.A. www.gehealthcare.com***. GE Healthcare Giraffe Omnibed is a combination of an infant incubator and an infant warmer.","HDGR52546, HDGR52736, HDGR52802, HDGR52861, HDGR52910, HDGR52958, HDGR53007, HDGR53058, HDGR53110, HDGR53185, HDGR52547, HDGR52737, HDGR52803, HDGR52862, HDGR52911, HDGR52959, HDGR53008, HDGR53059, HDGR53112, HDGR53186, HDGR52558, HDGR52739, HDGR52804, HDGR52863, HDGR52912, HDGR52960, HDGR53009, HDGR53060, HDGR53113, HDGR53187, HDGR52609, HDGR52740, HDGR52805, HDGR52864, HDGR52913, HDGR52961, HDGR53010, HDGR53061, HDGR53114, HDGR53188, HDGR52610, HDGR52741, HDGR52806, HDGR52865, HDGR52914, HDGR52962, HDGR53011, HDGR53062, HDGR53115, HDGR53189, HDGR52613, HDGR52742, HDGR52813, HDGR52866, HDGR52915, HDGR52963, HDGR53012, HDGR53063, HDGR53116, HDGR53190, HDGR52620, HDGR52743, HDGR52814, HDGR52867, HDGR52916, HDGR52964, HDGR53013, HDGR53064, HDGR53117, HDGR53191, HDGR52621, HDGR52744, HDGR52815, HDGR52868, HDGR52917, HDGR52965, HDGR53014, HDGR53065, HDGR53119, HDGR53192, HDGR52622, HDGR52745, HDGR52816, HDGR52869, HDGR52918, HDGR52966, HDGR53015, HDGR53066, HDGR53120, HDGR53193, HDGR52623, HDGR52746, HDGR52817, HDGR52870, HDGR52919, HDGR52967, HDGR53016, HDGR53067, HDGR53125, HDGR53194, HDGR52624, HDGR52747, HDGR52818, HDGR52871, HDGR52920, HDGR52968, HDGR53018, HDGR53068, HDGR53126, HDGR53195, HDGR52626, HDGR52748, HDGR52820, HDGR52872, HDGR52921, HDGR52969, HDGR53019, HDGR53069, HDGR53127, HDGR53196, HDGR52657, HDGR52749, HDGR52821, HDGR52873, HDGR52922, HDGR52970, HDGR53021, HDGR53070, HDGR53128, HDGR53197, HDGR52658, HDGR52750, HDGR52822, HDGR52874, HDGR52923, HDGR52971, HDGR53022, HDGR53071, HDGR53129, HDGR53213, HDGR52664, HDGR52751, HDGR52823, HDGR52875, HDGR52924, HDGR52972, HDGR53023, HDGR53072, HDGR53134, HDGR53214, HDGR52665, HDGR52752, HDGR52824, HDGR52876, HDGR52925, HDGR52973, HDGR53024, HDGR53073, HDGR53135, HDGR53215, HDGR52668, HDGR52753, HDGR52825, HDGR52877, HDGR52926, HDGR52974, HDGR53025, HDGR53074, HDGR53136, HDHR53216, HDGR52669, HDGR52754, HDGR52827, HDGR52878, HDGR52927, HDGR52975, HDGR53026, HDGR53075, HDGR53137, HDGR53217, HDGR52670, HDGR52755, HDGR52828, HDGR52879, HDGR52928, HDGR52976,",,"679 units","Neonatal beds and incubator display boards may randomly overwrite stored information and radiant heater and oxygen set points upon power up or recovery from a power failure. ",1/8/2013,"01/08/2013",4/17/2013,"04/17/2013"
"Drugs",64190,"Ongoing","D& S Herbals, LLC","Woodbridge","NJ","US","Voluntary: Firm Initiated","Press Release","Nationwide","D-323-2013","Class I","Super Power capsules, Proprietary Blend 570 mg, packaged in 2-count capsules per blister pack, Distributed by: Freedom Trading, NJ 08863, UPC 7 18122 90678 9.","Lot L08108, Exp 06/15 ",,"40,480 blister packs","Marketed Without An Approved NDA/ANDA: This dietary supplement has been found to contain sildenafil, an FDA approved drug for the treatment of male erectile dysfunction making this an unapproved new drug.",12/22/2012,"12/22/2012",5/22/2013,"05/22/2013"
"Biologics",64191,"Terminated","West Tennessee Regional Blood Center Inc","Jackson","TN","US","Voluntary: Firm Initiated","Letter","Tennessee","B-1086-13","Class II","Red Blood Cells Leukocytes Reduced","W040812117259; ",,"1","Blood product, which wase collected from a donor who traveled to a malarial endemic area, was distributed. ",1/21/2013,"01/21/2013",5/8/2013,"05/08/2013"
"Biologics",64192,"Terminated","Central Pennsylvania Blood Bank","Hummelstown","PA","US","Voluntary: Firm Initiated","Other","Pennsylvania","B-1087-13","Class II","Red Blood Cells Leukocytes Reduced","W270112571961; ",,"1","Blood product, which was collected from a donor who traveled to a malarial endemic area, was distributed.",12/24/2012,"12/24/2012",5/8/2013,"05/08/2013"
"Biologics",64193,"Terminated","Hemacare Corporation","Van Nuys","CA","US","Voluntary: Firm Initiated","Telephone","California","B-0891-13","Class III","Platelets Pheresis Leukocytes Reduced Irradiated","W313712022984",".","1","Blood product, collected from a donor with an initially positive test for syphilis, was distributed.",12/10/2012,"12/10/2012",2/27/2013,"02/27/2013"
"Devices",64194,"Ongoing","Synthes USA HQ, Inc.","West Chester","PA","US","Voluntary: Firm Initiated","Letter","Distributed in the states of IN, OH, PA, and TX.","Z-0956-2013","Class II","Variable Angle Locking Compression Plate/VA-LCP Dorsal Distal Radius Plate, Part Number 02.115.431. Indicated for: Dorsally displaced fractures, Open joint reconstruction, and Corrective osteotomies after distal radius malunion.","Lot number 7965181",".","4","It was discovered that one of the VA-LCP Dorsal Distal Radius Plates was incorrectly etched as Part Number 02.115.431 (110 degree) instead of the correct Part Number 02.115.231 (90 degree). ",1/11/2013,"01/11/2013",3/27/2013,"03/27/2013"
"Devices",64195,"Ongoing","Synthes USA HQ, Inc.","West Chester","PA","US","Voluntary: Firm Initiated","Letter","Nationwide Distribution-including the states of CO, LA, MD, MN, NY, PA, RI, TN, TX and UT.","Z-0903-2013","Class II","Synthes Multi-Vector Distractor Body, Part Number 487.931. For mandibular bone lengthening.","Part number 487.831 - Lot numbers 7826459,7750064, 7667285, and 7806090.",,"2","It was discovered that the sheer pin on the Multi-Vector Distractor may not be made according to product specifications.",1/11/2013,"01/11/2013",3/13/2013,"03/13/2013"
"Devices",64195,"Ongoing","Synthes USA HQ, Inc.","West Chester","PA","US","Voluntary: Firm Initiated","Letter","Nationwide Distribution-including the states of CO, LA, MD, MN, NY, PA, RI, TN, TX and UT.","Z-0904-2013","Class II","Synthes Multi-Vector Distractor, Multi-axial Mandible Distractor (Right), Part Number 487.966. For mandibular bone lengthening.","Part number 487.966 - Lot numbers 7823465, 3817114, 7806086, 3824427, 3808871, 3794465, and 7793336.",,"24","It was discovered that the sheer pin on the Multi-Vector Distractor may not be made according to product specifications.",1/11/2013,"01/11/2013",3/13/2013,"03/13/2013"
"Devices",64195,"Ongoing","Synthes USA HQ, Inc.","West Chester","PA","US","Voluntary: Firm Initiated","Letter","Nationwide Distribution-including the states of CO, LA, MD, MN, NY, PA, RI, TN, TX and UT.","Z-0905-2013","Class II","Synthes Multi-Vector Distractor - Multi-axial Mandible Distractor (Left), Part Number 487.967. For mandibular bone lengthening.","Part number 487.967 - Lot numbers 7883454, 3808876, 7824423, 3800758, 3817116, 3794466",,"18","It was discovered that the sheer pin on the Multi-Vector Distractor may not be made according to product specifications.",1/11/2013,"01/11/2013",3/13/2013,"03/13/2013"
"Drugs",64197,"Ongoing","Hospira Inc.","Lake Forest","IL","US","Voluntary: Firm Initiated","Press Release","Nationwide","D-262-2013","Class I","Lactated Ringer's and 5% Dextrose Injection, USP, 1000 mL flexible container, Rx only, Hospira, Inc., Lake Forest, IL 60045 USA; NDC 0409-7929-09.","Lot #: 05-019-JT*, Exp 05/01/13; lot number * may be followed by 01, 90, or 91.",".","143,136 flexible containers","Non-Sterility: Confirmed customer complaint of product contaminated with mold.",1/25/2013,"01/25/2013",4/24/2013,"04/24/2013"
"Drugs",64198,"Ongoing","Pacira Pharmaceuticals, Inc.","San Diego","CA","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Nationwide distribution: AZ, DC, FL, GA, MA, NJ, NY, OH, and TX.","D-168-2013","Class II","EXPAREL (bupivacaine liposome injectable suspension), 1.3%, 266 mg/20 mL (13.3 mg/mL) single use vials, INVESTIGATIONAL USE. For Infiltration Only. Not for any other route of administration. Manufactured by Paelra Pharmaceuticals. Inc., San Diego, California, USA","Lot #11-2005Control #23542 Manufacture Date: 05Dec11 2011-L-009",,"324 vials","Subpotent; bupivacaine",12/17/2012,"12/17/2012",3/6/2013,"03/06/2013"
"Food",64199,"Ongoing","Whole Foods Market","Austin","TX","US","Voluntary: Firm Initiated","Press Release","Arkansas, California, Colorado, Connecticut, Florida, Idaho, Kansas, Louisiana, Maine, Massachusetts, Nevada , New Jersey, New Mexico, New York, Oklahoma, Rhode Island, Texas and Utah.","F-1005-2013","Class I","Whole Foods Market Whole Catch Wild Alaskan Sockeye Smoked Salmon, Cold Smoked Sliced, Net Wt. 4 oz, Distributed by Whole Foods Market, Austin, TX 78703","UPC code 0 99482 40880 0, Lot codes 7425A2298B and 7425A2297A. Sell by dates are applied at store level when product is thawed for sale and go 21 days out from date of thaw. Accordingly, the sell by dates should begin with 11/22/12 at the earliest and 2/15/13 at the latest. ",,"6924 retail units","The product has the potential to contaminated with Listeria Monocytogenes.",1/25/2013,"01/25/2013",3/6/2013,"03/06/2013"
"Devices",64200,"Ongoing","Synthes USA HQ, Inc.","West Chester","PA","US","Voluntary: Firm Initiated","Letter","Nationwide Distribution including the states of AZ, CA, CO, FL, IA, ID, GA, IL, IN, KY, LA, MA, MD, MI, MN, MO, MS, NC, NH, NJ, NV, NY, OH, PA, RI, TN, TX, UT, VT, WA, WI, and WV.","Z-1062-2013","Class II","Flexible Grip which is part of the Synthes Universal Nail System. Indicated for the conventional (non-locking) technique of treating stable diaphyseal fractures. ","Part number 355.28, all lot numbers",,"328","Synthes is initiating a voluntary recall of the Flexible Grip (Part number 355.28) which is part of the Universal Nail System, due to the potential lack of the ability to thoroughly clean the instrument. ",1/11/2013,"01/11/2013",4/17/2013,"04/17/2013"
"Devices",64201,"Ongoing","Philips Healthcare Inc.","Andover","MA","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution - USA (nationwide) and Internationally to ALGERIA, ANGOLA, AUSTRALIA, AUSTRIA, BAHRAIN, BELGIUM, BULGARIA, COLOMBIA, CROATIA (LOCAL NAME HYVATSKA), CYPRUS, CZECH REPUBLIC, DENMARK, DOMINICAN REPUBLIC, EGYPT, ESTONIA, FINLAND, FRANCE, GABON, GERMANY, HONG KONG, HUNGARY, ICELAND, INDIA, INDONESIA, IRAN (ISLAMIC REPUBLIC OF), IRAQ, IRELAND, ISRAEL, ITALY, JORDAN, KENYA, REPUBLIC OF KOREA, KUWAIT, LATVIA, LEBANON, LIBYAN ARAB JAMAHIRIYA, LITHUANIA, MALAYSIA, MALTA, MAURITIUS, MOROCCO, NAMIBIA, NETHERLANDS, NEW ZEALAND, NORWAY, OMAN, PALESTINE, POLAND, PORTUGAL, ROMANIA, SAUDI ARABIA, SINGAPORE, SLOVAKIA (SLOVAK REPUBLIC), SLOVENIA, SOUTH AFRICA, SPAIN, SRI LANKA, SWEDEN, SWITZERLAND, SYRIAN ARAB REPUBLIC, TANZANIA, THAILAND, TRINIDAD AND TOBAGO, TUNISIA, TURKEY, UNITED ARAB EMIRATES, UNITED KINGDOM, AND VIET NAM.","Z-0871-2013","Class II","Philips HeartStart XL+ Defibrillator/Monitor Model number: 861290 The HeartStart XL+ is intended for use in a hospital setting by qualified medical personnel trained in the operation of the device and qualified by training in basic life support, advanced life support or defibrillation","Serial number range: USO1100100 - USO1100372, USN1100376 - USN1100960, USD1100961 - USD1101095, US11201096 - US11201186, US21201187 - US21201239, US31201240 - US31201537, US41201538 - US41201585, US51201586 - US51201721, US61201722 -US61201924, US71201925 - US71202048, US81202049 - US81202168, US91202169- US91202514, USO1202515 - USO1202990, USN1202991 - USN1203537, USD1203538- USD1203968, US11303969 - US11303972",".","3785 units","Philips HeartStart XL+ Defibrillator/Monitor may become locked out of clinical use ",1/28/2013,"01/28/2013",2/27/2013,"02/27/2013"
"Devices",64202,"Ongoing","Merit Medical Systems, Inc.","South Jordan","UT","US","Voluntary: Firm Initiated","Telephone","Worldwide Distribution - USA including the states of NJ, FL, GA, MO, AZ, UT and the country of Denmark","Z-0866-2013","Class II","Merit Medical Systems Inc., Resolve Biliary Locking Drainage Catheter, Models RBC and RBDC, used for drainage of bile within the biliary system.","Lot numbers H399931S1; H411376; H399938S1; H411373; H399940S1; H411374; H399942S1; H411375; H399948S1; H411380; H399950S1; H411377; H39952S1; H411378; H39953S1; H411379.",".","387 units","Merit Medical Systems is recalling certain lots of ReSolve Biliary Locking Drainage Catheters due to a consumer complaint that a catheter was observed to be in several pieces under patient fluoroscopic visualization.",1/16/2013,"01/16/2013",2/27/2013,"02/27/2013"
"Food",64203,"Ongoing","Giant Greens, Inc. ","Kent","WA","US","Voluntary: Firm Initiated","Press Release","Products distributed in Alaska, Idaho, Oregon, Washington, and British Columbia, Canada.","F-1012-2013","Class I","Spicy Sprouts, packaged in a 4 oz. clamshell container or 85 gram package.The product is sold under Sprouters Northwest or LifeForce brand. The Sprouters Northwest, 4 oz., has UPC is 8 15098 00202 3. The LifeForce, 85 gram, has UPC 8 51042 00401 9. The Sprouters Northwest, 4 oz., is labeled in parts: ''***SPICY SPROUTS***a blend of clover and radish sprouts***Sprouters NORTHWEST, INC.***KEEP REFRIGERATED***NET WT. 4.0 oz.***DISTRIBUTED BY: SPROUTERS NORTHWEST, INC., KENT, WA 98032***SproutersNorthwest.com***''. The LifeForce, 85 gram, is labeled in parts: ''***SPICY SPROUTS***a blend of clover and radish sprouts***LifeForce***KEEP REFRIGERATED***NET WT 85g***PRODUCED FOR: LIFE FORCE FOODS LLC, BALTIMORE, MD 21202***www.BroccoSprouts.com***''. ","The Best by Dates are including all and up to 2/17/2013",,"7212/4 oz. Packages and 420/85 gram Packages.","Spicy Sprouts are recalled due to a potential contamination with Listeria monocytogenes.",1/28/2013,"01/28/2013",3/6/2013,"03/06/2013"
"Food",64203,"Ongoing","Giant Greens, Inc. ","Kent","WA","US","Voluntary: Firm Initiated","Press Release","Products distributed in Alaska, Idaho, Oregon, Washington, and British Columbia, Canada.","F-1017-2013","Class I","Mung Bean sprouts is packaged in a 8 oz clamshell container or 5 lb. bag and sold under the Sprouters Northwest or Life Force brand. The Life Force foods, 8 oz, has UPC 8 15098 00107 1; The Sprouters Northwest, 5 lb., has UPC 0 33383 70258 2. The Life Force foods, 8 oz., is labeled in parts: ''***MUNG BEAN SPROUTS***KEEP REFRIGERATED***NET WT. 4 OZ.***MANUFACTURED FOR: BRASSICA SPROUT GROUP, BALTIMORE, MD 21202***www.broccosprouts.com***''. The Sprouters Northwest, 5 lb., is labeled in parts: ''***BEAN SPROUTS***KEEP REFRIGERATED***NET WT. 5 LBS***Sprouters NORTHWEST***KENT, WA 98032***''.","The Best by Dates are including all and up to 2/17/2013",,"33774/8 oz. Packages and 416/5 lb. Bags","Mung Bean sprouts are recalled due to a potential contamination with Listeria monocytogenes.",1/28/2013,"01/28/2013",3/6/2013,"03/06/2013"
"Food",64203,"Ongoing","Giant Greens, Inc. ","Kent","WA","US","Voluntary: Firm Initiated","Press Release","Products distributed in Alaska, Idaho, Oregon, Washington, and British Columbia, Canada.","F-1018-2013","Class II","Wheatgrass is packaged in a pint or cup, 16 oz. bag, or 5 lb. Flat cardboard box and sold under the Sprouters Northwest brand. The Wheatgrass in a pint or cup has UPC 0 79566 12380 5; The wheatgrass in 16 oz. bag or 5 lb. Flat cardboard box does not have any UPC. The wheatgrass, Sprouters Northwest, pint or cup., is labeled in parts: ''***Wheatgrass***CERTIFIED ORGANIC***Pint***Sprouters NORTHWEST, INC.***KENT, WA 98032***''. The wheatgrass in 16 oz. bag is labeled in parts: ''***ORGANIC WHEATGRASS***SKU# 16OZCW***Keep Refrigerated***Not For Retail Sales as Packaged***''. The wheatgrass in 5 lb. Flat cardboard box is labeled in parts: ''***Wheatgrass***1 Ea. 21''X21'' Wheatgrass/case***Item 40019***''.","The Best by Dates are including all and up to 2/17/2013",,"3024/1 pint Packages; 888 cups; 63/16 oz. Bags; and 494/5 lbs. Flat boxes; ","Wheatgrass is recalled due to a potential contamination with Listeria monocytogenes.",1/28/2013,"01/28/2013",3/6/2013,"03/06/2013"
"Food",64203,"Ongoing","Giant Greens, Inc. ","Kent","WA","US","Voluntary: Firm Initiated","Press Release","Products distributed in Alaska, Idaho, Oregon, Washington, and British Columbia, Canada.","F-1019-2013","Class II","Organic Pea Shoots are packaged in a 3 oz. or 4 oz packages. Product is sold under the Life Force or Trader Joe's brand. The Life Force, 3 oz, has UPC 8 51042 00414 9. The Trader Joe's, 4 oz, has UPC 0092 7567. The Life Force, 3 oz, is labeled in parts: ''***Organic Pea Shoots***Life Force foods***KEEP REFRIGERATED***NET WT. 3.0 oz***DISTRIBUTED BY: LIFEFORCE FOODS, LLC***BALTIMORE, MD 21202***''. The Trader Joe's, 4 oz, is labeled in parts: ''***ORGANIC PEA SHOOTS***TRADER JOE'S***PERISHABLE, KEEP REFRIGERATED***RINSE BEFORE USING***NET WT. 4 OZ***SKU# 92756***DIST. & SOLD EXCLUSIVELY BY: TRADER JOE'S, MONROVIA, CA 91016***''. ","The Best by Dates are including all and up to 2/16/2013",,"390/3 oz. Packages and 3180/4 oz. Packages","Organic Pea Shoots are recalled due to a potential contamination with Listeria monocytogenes.",1/28/2013,"01/28/2013",3/6/2013,"03/06/2013"
"Food",64203,"Ongoing","Giant Greens, Inc. ","Kent","WA","US","Voluntary: Firm Initiated","Press Release","Products distributed in Alaska, Idaho, Oregon, Washington, and British Columbia, Canada.","F-1013-2013","Class I","Alfalfa sprouts, packaged in a 4 oz. clamshell container or 85 gram package.Product is sold under Sprouters Northwest or LifeForce brand. The Sprouters Northwest, 4oz., has UPC 8 15098 00108 8; The LifeForce, 85 gram, has UPC 8 51042 00402 6. The Sprouters Northwest, 4oz, is labeled in parts: ''***ALFALFA SPROUTS***Sprouters NORTHWEST****KEEP REFRIGERATED***NET WT. 4.0 oz.***DISTRIBUTED BY: SPROUTERS NORTHWEST, KENT, WA 98032***www.SproutersNorthwest.com***''. The LifeForce, 85 gram, is labeled in parts: ''***ALFALFA SPROUTS***LifeForce foods***KEEP REFRIGERATED***NET WT 85g***PRODUCED FOR: LIFE FORCE FOODS LLC, BALTIMORE, MD 21202***www.BroccoSprouts.com***''.","The Best by Dates are including all and up to 2/17/2013",,"14562/4 oz. Packages and 3024/85 g. Packages","Alfalfa sprouts are recalled due to a potential contamination with Listeria monocytogenes.",1/28/2013,"01/28/2013",3/6/2013,"03/06/2013"
"Food",64203,"Ongoing","Giant Greens, Inc. ","Kent","WA","US","Voluntary: Firm Initiated","Press Release","Products distributed in Alaska, Idaho, Oregon, Washington, and British Columbia, Canada.","F-1016-2013","Class I","3 Bean Munchies sprouts is a mixture of Green Peas, Cow Peas, Red Lentils and Garbanzo Beans. Product is packaged in a 4 oz clamshell container and sold under the Sprouters Northwest brand. Product has UPC 8 15098 00204 7. The 3 Bean Munchies sprouts, 4 oz., is labeled in parts: ''***3 BEAN MUNCHIES***a blend of sprouts from green peas, cow peas, red and green lentils, and adzuki beans***KEEP REFRIGERATED***NET WT. 4.0 oz.***DISTRIBUTED BY: SPROUTERS NORTHWEST, INC., KENT, WA 98032***www.SproutersNorwthest***''. ","The Best by Dates are including all and up to 2/17/2013",,"1146/4 oz Packages","3 Bean Munchies sprouts are recalled due to a potential contamination with Listeria monocytogenes.",1/28/2013,"01/28/2013",3/6/2013,"03/06/2013"
"Food",64203,"Ongoing","Giant Greens, Inc. ","Kent","WA","US","Voluntary: Firm Initiated","Press Release","Products distributed in Alaska, Idaho, Oregon, Washington, and British Columbia, Canada.","F-1010-2013","Class I","Clover sprouts, product is packaged in a 4 oz or 5 oz. clamshell containers, and 1 lb. bag or 2 lb. tray. Product is sold under brand Sprouters Northwest. Clover Sprouts, 4oz container, has a UPC 8 15098 00201 6; Clover Sprouts, 5oz container, has a UPC 0 33383 70235 3; Clover Sprouts, 1 lb bag, has a UPC 0 79566 12351 5; Clover Sprouts, 2 lb tray, has a UPC 0 79566 12351 5; The Clover Sprouts, 4 oz., Sprouters Northwest brand is labeled in parts: ''***CLOVER SPROUTS***Sprouters NORTHWEST***NET WT 4.0 oz***KEEP REFRIGERATED***DISTRIBUTED BY: SPROUTERS NORTHWEST, KENT, WA 98032***www.SproutersNorthwest.com***''. The Clover Sprouts, 5 oz., Sprouters Northwest brand is labeled in parts: ''***CLOVER ***Sprouters NORTHWEST, INC. KENT, WA 98032***NET WT 5.0 oz***KEEP REFRIGERATED***''. The Clover Sprouts, 1 LB., Sprouters Northwest brand is labeled in parts: ''***CLOVER SPROUTS***NET WT. 1 LB***KEEP REFRIGERATED***Sprouters NORTHWEST, KENT, WA 98032***''. The Clover Sprouts, 2 LB., Sprouters Northwest brand is labeled in parts: ''***Clover Sprouts***2 lb.*** Sprouters NORTHWEST, KENT, WA 98032***''. ","The Best by Dates are including all and up to 2/17/2013.",,"14154/4 oz. Packages; 5130/5 oz. Packages; 24287/1 lb. Bags; and 552/2 lb. Trays","Clover sprouts are recalled due to a potential contamination with Listeria monocytogenes.",1/28/2013,"01/28/2013",3/6/2013,"03/06/2013"
"Food",64203,"Ongoing","Giant Greens, Inc. ","Kent","WA","US","Voluntary: Firm Initiated","Press Release","Products distributed in Alaska, Idaho, Oregon, Washington, and British Columbia, Canada.","F-1011-2013","Class I","Brocco Sprouts Sandwich Blend, packaged in a 4 oz. clamshell container, the UPC is 8 15098 00028 9. The product is labeled in parts: ''***BROCCO SPROUTS SANDWICH BLEND***broccoli & clover sprouts***NET WT. 4.0 oz***DISTRIBUTED BY: BRASSICA PROTECTION PRODUCTS LLC, BALTIMORE, MD 21224***www.BroccoSprouts.com***''Growers***Sprouters Northwest (Kent, WA)***''. ","The Best by Dates are including all and up to 2/17/2013.",,"2306/4 oz. Packages","Brocco Sprouts Sandwich Blend are recalled due to a potential contamination with Listeria monocytogenes.",1/28/2013,"01/28/2013",3/6/2013,"03/06/2013"
"Food",64203,"Ongoing","Giant Greens, Inc. ","Kent","WA","US","Voluntary: Firm Initiated","Press Release","Products distributed in Alaska, Idaho, Oregon, Washington, and British Columbia, Canada.","F-1014-2013","Class I","Brocco sprouts is broccoli sprouts, packaged in a 4 oz. clamshell container or 85 gram package. The Brocco sprouts, 4oz., distributed BRASSICA, has UPC 8 15098 00025; The Brocco sprouts, 85 gram, produced for LIFE FORCE, has UPC 8 51042 00400 2. The Brocco sprouts, 4oz, is labeled in parts: ''***BROCCO SPROUTS***broccoli sprouts***Keep Refrigerated***NET WT. 4.0 oz.***DISTRIBUTED BY: BRASSICA PROTECTION PRODUCTS LLC, BALTIMORE, MD 21224***Growers***Sprouters Northwest (Kent, WA)***www.BroccoSprouts.com***''. The LifeForce, 85 gram, is labeled in parts: ''***BROCCO SPROUTS***broccoli sprouts***Keep Refrigerated***NET WT 85 g***PRODUCED FOR: LIFE FORCE FOODS LLC, BALTIMORE, MD 21202***www.BroccoSprouts.com***''.","The Best by Dates are including all and up to 2/17/2013",,"792/4 oz. Packages and 528/85 g. Packages","Brocco sprouts are recalled due to a potential contamination with Listeria monocytogenes.",1/28/2013,"01/28/2013",3/6/2013,"03/06/2013"
"Food",64203,"Ongoing","Giant Greens, Inc. ","Kent","WA","US","Voluntary: Firm Initiated","Press Release","Products distributed in Alaska, Idaho, Oregon, Washington, and British Columbia, Canada.","F-1015-2013","Class I","Deli sprouts is a mixture of Clover, Fenugreek, Lentils, an Radish sprouts. Product is packaged in a 4 oz. or 5 oz clamshell container. Product is sold under the Sprouters Northwest brand. The Deli sprouts, 4 oz., has UPC 8 79566 12305 4. The Deli sprouts, 5 oz., as UPC 0 79566 12360 7. The Deli sprouts, 4 oz., is labeled in parts: ''***DELI SPROUTS***INGREDIENTS: CLOVER, FENUGREEK, LENTILS, AND RADISH***KEEP REFRIGERATED***NET WT. 4.0 oz.***DISTRIBUTED BY: SPROUTERS NORTHWEST, INC., KENT, WA 98032***www.SproutersNorwthest***''. The Deli sprouts, 5 oz., is labeled in parts: ''***DELI***INGREDIENTS: CLOVER, FENUGREEK, LENTILS, AND RADISH***KEEP REFRIGERATED***NET WT. 5 oz.***Sprouters NORTHWEST, INC. KENT, WA 98032***''.","The Best by Dates are including all and up to 2/17/2013",,"294/4 oz. Packages; 174/5 oz. Packages.","Deli sprouts are recalled due to a potential contamination with Listeria monocytogenes.",1/28/2013,"01/28/2013",3/6/2013,"03/06/2013"
"Devices",64204,"Ongoing","Carefusion 303 Inc","San Diego","CA","US","Voluntary: Firm Initiated","Letter","Nationwide Distribution including the states of AK, CA, CO, IL, MO, NV, NY, TX and UT.","Z-0832-2013","Class II","CareFusion SmartSite Gravity Blood Set Model 42082E. Used to administer blood and blood products through a needle or catheter inserted into the patient's artery or vein.","Lot number 12055225",".","5,050 units","CareFusion is recalling the SmartSite Gravity Blood Set as a result of a potential for separation at the connection of the drip chamber and tubing . The separation may be observed at priming or observed during use. If a separation between the drip chamber and tubing occurs, this could cause a delay in treatment.",12/20/2012,"12/20/2012",2/27/2013,"02/27/2013"
"Biologics",64205,"Terminated","Lions Eye Institute for Transplant & Research, Inc.","Tampa","FL","US","Voluntary: Firm Initiated","Letter","Indonesia; Egypt; Mexico; Saudi Arabia; Florida; Missouri; New Jersey; Dominican Republic","B-0970-13","Class II","Cornea","2012010601; 2012032093; 2012042243; 2012042299; 2012053203; 2012053261; 2012064195; 2012074467; 2012074497; 2012074999; 2012085207; 2012096095; 2012106947; 2012107037; 2012107087; 2012107203; 2012107253; 2012128065; 2012128281; 2012128317; 2011127530; 2011127666; 2012010602; 2012032094; 2012042244; 2012042300; 2012053204; 2012053262; 2012064196; 2012074468; 2012074498; 2012075000; 2012085208; 2012096096; 2012106948; 2012107038; 2012107088; 2012107204; 2012107254; 2012117420; 2012128066; 2012128282; 2012031727; 2012021505; 2012021506; 2012021291; 2012021292; 2011127529; 2011127665",,"49","Human Corneas, recovered from a donor whose donor screening may have been performed in a manner that did not determine the donor was free from risk factors for, and clinical evidence of infection due to relevant communicable disease agents and diseases, were distributed. ",1/11/2013,"01/11/2013",3/6/2013,"03/06/2013"
"Biologics",64206,"Terminated","Florida Lions Eye Bank, Inc.","Miami","FL","US","Voluntary: Firm Initiated","Letter","Nationwide; Jamica; Costa Rica; Egypt, El Salvador, St. Thomas, Venezuela, Ecuador, China and Guatemala","B-0971-13","Class III","Cornea","0801006COS, 0801006COD, 0801016COD, 0801016COS, 0801020COD, 0801022COS, 0801022COD, 0802009COSG2, 0802009COD, 0802009COSG1, 0802015COD, 0802015COSGPC, 0802015COS, 0802023COD, 0802023COS, 0802060COS, 0802060COD, 0802076COD, 0802076COS, 0802080CODG2, 0802080CODG1, 0802080COSG1, 0802080COSG2, 0802084COSG1, 0802084COSG2, 0802084CODG1, 0802084CODG2, 0803007COS, 0803007COD, 0803011COD, 0803011COS, 0803025COS, 0803025COD, 0803025COSGPC, 0803058COD, 0803076CODG1, 0803076CODG2, 0803076COSG2, 0803076COSG1, 0804015COD, 0804015COS, 0804042COD, 0805019COSG2, 0805019COSG1, 0805019COD, 0805056COS, 0805056COD, 0805056COSGPC, 0805064COD, 0805064COS, 0806007COD, 0806007COS, 0806014CODG2, 0806014COS, 0806014CODG1, 0806018COD, 0806018COS, 0806022COS, 0806022COD, 0806024COD, 0806024COSG2, 0806024COSG1, 0806032CODGPC, 0806032COSG1, 0806032COD, 0806032COSG2, 0806040CODG1, 0806040CODG2, 0806040COSG2, 0806040COSG1, 0806046COSG2, 0806046COSG1, 0806046CODG2, 0806046CODG1, 0806058COS, 0806058COD, 0807006COS, 0807006COD, 0807037COS, 0807037COD, 0807041COS, 0807041COD, 0807049COD, 0807049COS, 0808009COD, 0808009COS, 0808009COSGPC, 0808009CODGPC, 0808012COD, 0808041COD, 0808041COS, 0808046COS, 0808046COD, 0808046COSGPC, 0808046CODGPC, 0809002COD, 0809002COS, 0809028COD, 0809028COS, 0809075COSGPC, 0809075COS, 0809075COD, 0810002COD, 0810002COS, 0810012CODG2, 0810012COS, 0810012CODG1, 0810041COS, 0810041COD, 0811008CODG1, 0811008CODG2, 0811008COSG2, 0811008COSG1, 0811057COS, 0811057CODGPC, 0811057COD, 0811069COD, 0811069COS, 0811080CODG1, 0811080COSG1, 0811080CODG2, 0811080COSG2, 0811084COSG1, 0811084CODG2, 0811084CODG1, 0811084COSG2, 0812015COD, 0812015COS, 0812045CODG2, 0812045CODG1, 0812045COSG2, 0812045COSG1, 0812045COD, 0812059COSG2, 0812059COSG1, 0812059CODG2, 0812059CODG1, 0812060COD, 0812060COS, 0901001COS, 0901001COD, 0901016COD, 0901016COS, 0901021COS, 0901021COD, 0901055COS, 0901055COD, 0901059COS, 0901059COD, 0901066CODGPC, 0901066COS, 0901066COD, 0902020COS, 0902020COD, 0902028COD, 0902028COS, 0902032COS, 0902032COD, 0902043CODG1",,"693","Human Corneas, recovered from donors whose donor eligibility was not determined by using appropriate FDA-licensed, approved, or cleared donor screening tests, in accordance with the manufacturer's instructions, to adequately and appropriately reduce the risk of transmission of relevant communicable disease agents or diseases, were distributed. ",12/21/2012,"12/21/2012",3/13/2013,"03/13/2013"
"Biologics",64207,"Terminated","Medic Inc","Knoxville","TN","US","Voluntary: Firm Initiated","Letter","Tennessee","B-1113-13","Class II","Red Blood Cells","9505841; 9088034; 9427804; 9226669; 9359488; ",,"5","Blood products, collected from a donor who was in close contact with an individual diagnosed with viral hepatitis, were distributed.",1/4/2013,"01/04/2013",5/8/2013,"05/08/2013"
"Biologics",64207,"Terminated","Medic Inc","Knoxville","TN","US","Voluntary: Firm Initiated","Letter","Tennessee","B-1112-13","Class II","Platelets","9440117; 9427804; 9226669; ",,"3","Blood products, collected from a donor who was in close contact with an individual diagnosed with viral hepatitis, were distributed.",1/4/2013,"01/04/2013",5/8/2013,"05/08/2013"
"Biologics",64207,"Terminated","Medic Inc","Knoxville","TN","US","Voluntary: Firm Initiated","Letter","Tennessee","B-1110-13","Class II","Fresh Frozen Plasma","9468600; 9505841; ",,"2","Blood products, collected from a donor who was in close contact with an individual diagnosed with viral hepatitis, were distributed.",1/4/2013,"01/04/2013",5/8/2013,"05/08/2013"
"Biologics",64207,"Terminated","Medic Inc","Knoxville","TN","US","Voluntary: Firm Initiated","Letter","Tennessee","B-1109-13","Class II","Red Blood Cells Leukocytes Reduced","W071208025659; 9312114; 9468600; 9263803; ",,"4","Blood products, collected from a donor who was in close contact with an individual diagnosed with viral hepatitis, were distributed.",1/4/2013,"01/04/2013",5/8/2013,"05/08/2013"
"Biologics",64207,"Terminated","Medic Inc","Knoxville","TN","US","Voluntary: Firm Initiated","Letter","Tennessee","B-1111-13","Class II","Red Blood Cells Irradiated","9440117; ",,"1","Blood products, collected from a donor who was in close contact with an individual diagnosed with viral hepatitis, were distributed.",1/4/2013,"01/04/2013",5/8/2013,"05/08/2013"
"Biologics",64207,"Terminated","Medic Inc","Knoxville","TN","US","Voluntary: Firm Initiated","Letter","Tennessee","B-1108-13","Class II","Red Blood Cells (Apheresis) Leukocytes Reduced","W071209008364 Part 1; W071209008364 Part 2; ",,"2","Blood products, collected from a donor who was in close contact with an individual diagnosed with viral hepatitis, were distributed.",1/4/2013,"01/04/2013",5/8/2013,"05/08/2013"
"Biologics",64208,"Terminated","American Red Cross Blood Services Heart of America Region","Peoria","IL","US","Voluntary: Firm Initiated","Telephone","Illinois, Oklahoma","B-0968-13","Class II","Cryoprecipitated AHF, Pooled","22638; 22639; 22640; 22641; 22642; 22643; 22644; 22645; 22599; 22600; 22601; 22604; 22605; 22606; 22607; 22608; 22609; 22610; 22611; 22612; 22614; 22615; 22616; 22617; 22618; 22619; 22620; 22621; 22622; 22624; 22625; 22626; 22627; 22628; 22629; 22630; 22631; 22632; 22633; 22634; 22635; 22636; 22637; 22729; 22648; 22649; 22650; 22651; 22652; 22653; 22716; 22718; 22731; 22654; 22655; 22656; 22657; 22658; 22659; 22660; 22661; 22662; 22663; 22664; 22665; 22666; 22667; 22668; 22669; 22670; 22671; 22675; 22678; 22680; 22681; 22682; 22683; 22684; 22686; 22687; 22688; 22689; 22690; 22691; 22692; 22693; 22694; 22695; 22696; 22697; 22701; 22714; 22715; 22719; 22720; 22721; 22724; 22726; 22727; 22728;22735; 22737; 22750; 22752; 22754; 22763; 22764; 22768; 22771; 22776; 22777; 22779; 22780; 22781; 22782",,"115","Cryoprecipitated AHF, which failed to meet the minimum potency of 80IU of AHF (Factor VIII), was distributed.",12/5/2012,"12/05/2012",3/6/2013,"03/06/2013"
"Biologics",64208,"Terminated","American Red Cross Blood Services Heart of America Region","Peoria","IL","US","Voluntary: Firm Initiated","Telephone","Illinois, Oklahoma","B-0969-13","Class II","Cryoprecipitated AHF","40FC25610; 40FL47750; 40FL47755; 40GG25279; 40GT74300; 40GZ46302; 40K08469; 40LM12864; 40LT59262; 40LT59302; 40LT59322; 40LT59338; 40LX27007; 40LX27012; 40LZ36145",,"15","Cryoprecipitated AHF, which failed to meet the minimum potency of 80IU of AHF (Factor VIII), was distributed.",12/5/2012,"12/05/2012",3/6/2013,"03/06/2013"
"Biologics",64209,"Terminated","ITXM Clinical Services","Pittsburgh","PA","US","Voluntary: Firm Initiated","Telephone","Pennsylvania","B-1088-13","Class III","Red Blood Cells","W086712001888; W086712001971; ",,"2","Blood products, leukodepleted greater than five days after collection, were distributed.",12/12/2012,"12/12/2012",5/8/2013,"05/08/2013"
"Biologics",64210,"Terminated","CryoLife, Inc.","Kennesaw","GA","US","Voluntary: Firm Initiated","Letter","Tennessee; Missouri; Kentucky; Texas","B-0768-13","Class II","Vascular Graft","9887377; 9887385; 9887396; 9887480",".","4","Human Tissues, recovered from a donor whose donor eligibility determination did not identify if the donor was free from risk factors for and clinical evidence of, infection due to relevant communicable disease agents, were distributed. ",12/12/2012,"12/12/2012",2/27/2013,"02/27/2013"
"Biologics",64211,"Ongoing","Smiths Medical ASD, Inc.","Rockland","MA","US","Voluntary: Firm Initiated","Letter","NationwideForeign: Canada, Mexico, Santo Domingo, Panama, Equador, Chile, Portugual, Qatar, Ireland, Libiya, UAE, Great Britain, India,Germany, Italy, Oman. Belgium, Netherlands, Switzerland, Australia, Austria, Poland, Romania, Hungary, Vietnam,Egypt, Japan, Spain","B-1052-13","Class II","Level 1 Fast Flow Fluid Warmer's with and without airdetection Reorder Number: H-1200 115V and 230V","Serial Numbers:S10000010 S10000758 S10000897 S101A00083 S103A00018 S103A00019 S103A00020 S103A00025 S103A00027 S103A00028 S103A00029 S103A00035 S103A00037 S103A00039 S103A00041 S103A00047 S103A00050 S103A00051 S103A00052 S103A00053 S103A00055 S103A00056 S103A00057 S103A00058 S103A00060 S103A00061 S103A00062 S103A00063 S103A00064 S103A00065 S103A00066 S103A00068 S103A00069 S103A00070 S103A00071 S103A00072 S103A00074 S103A00077 S103A00078 S103A00079 S103A00080 S103A00081 S103A00082 S103A00084 S103A00085 S103A00086 S103A00087 S103A00088 S103A00089 S103A00090 S103A00091 S103A00092 S103A00093 S103A00094 S103A00095 S103A00097 S103A00098 S103A00099 S103A00100 S103A00102 S103A00103 S103A00104 S103A00105 S103A00106 S103A00107 S103A00112 S103A00117 S103A00118 S103A00119 S103A00129 S103A00130 S103A00131 S103A00132 S103A00133 S103A00134 S103A00135 S103A00136 S103A00137 S103A00138 S103A00139 S103A00140 S103A00141 S103A00142 S103A00143 S103A00144 S103A00145 S103A00146 20050458 S10000851 S103B00044 S103B00093 S103B00106 S103B00116 S103B00118 S103B00121 S103B00123 S103B00130 S103B00133 S103B00134 S103B00135 S103B00136 S103B00137 S103B00138 S103B00139 S103B00140 S103B00141 S103B00142 S103B00143 S103B00144 S103B00147 S103B00148 S103B00149 S103B00150 S103B00153 S103B00155 S103B00156 S103B00163 S103B00164 S103B00165 S103B00166 S103B00167 S103B00168 S103B00169 S103B00170 S103B00171 S103B00172 S103B00173 S103B00174 S103B00175 S103B00176 S103B00177 S103B00178 S103B00179 S103B00180 S103B00181 S103B00182 S103B00183 S103B00184 S103B00185 S103B00186 S103B00187 S103B00188 S103B00189 S103B00190 S103B00191 S103B00192 S103B00193 S103B00194 S103B00195 S103B00196 S103B00197 S103B00198 S103B00199 S103B00200 S103B00201 S103B00202 S103B00203 S103B00204 S103B00205 S103B00206 S103B00207 S103B00208 S103B00209 S103B00210 S103B00211 S103B00212 S103B00213 S103B00214 S103B00215 S103B00216 S103B00217 S103B00218 S103B00219 S103B00220 S103B00221 S103B00222 S103B00223 S103B00225 S103B00226 S103B00227 S103B00228 S103B00229 S103B00230 S103B00231 S103B00232 S",,"331 (223 US, 108 OUS)","Level 1 Fast Flow Fluid Warmer, with a circuit board component that may result in false over temperature alarm, was distributed. ",1/28/2013,"01/28/2013",3/20/2013,"03/20/2013"
"Biologics",64211,"Ongoing","Smiths Medical ASD, Inc.","Rockland","MA","US","Voluntary: Firm Initiated","Letter","NationwideForeign: Canada, Mexico, Santo Domingo, Panama, Equador, Chile, Portugual, Qatar, Ireland, Libiya, UAE, Great Britain, India,Germany, Italy, Oman. Belgium, Netherlands, Switzerland, Australia, Austria, Poland, Romania, Hungary, Vietnam,Egypt, Japan, Spain","B-1051-13","Class II","Level 1 Fast Flow Fluid Warmer's without air detectionReorder Number: H-1000 100V, 115V and Level Fast Flow Fluid Warmer's without air detection 230V","Serial Numbers: S104C00013, S104C00014, S104C00015, S104C00016, S104C00019, S104C00020, S104C00021, S104C00022, S104C00023, S104C00024, S104C00025, S104C00026, S104C00027, S104C00028, S104C00029, S104C00030, S104C00031, S104C00032, S104C00033, S104C00034, S104C00035, S104C00036, S104C00037, S104C00038, S104C00039, S104C00040, S104C00041, S104C00042, S104C00043",,"29 OUS","Level 1 Fast Flow Fluid Warmer, with a circuit board component that may result in false over temperature alarm, was distributed. ",1/28/2013,"01/28/2013",3/20/2013,"03/20/2013"
"Biologics",64211,"Ongoing","Smiths Medical ASD, Inc.","Rockland","MA","US","Voluntary: Firm Initiated","Letter","NationwideForeign: Canada, Mexico, Santo Domingo, Panama, Equador, Chile, Portugual, Qatar, Ireland, Libiya, UAE, Great Britain, India,Germany, Italy, Oman. Belgium, Netherlands, Switzerland, Australia, Austria, Poland, Romania, Hungary, Vietnam,Egypt, Japan, Spain","B-1053-13","Class II","Normoflo Irrigation Fluid WarmerReorder Number: H-1100 230V","Serial Numbers: S105B00009, S105B00010, S105B00011, S105B00012, S105B00015, S105B00016, S105B00017, S105B00018, S105B00019, S105B00020, S105B00021, S105B00022, S105B00024, S105B00027, S105B00028, S105B00032, S105B00041 ",,"17 Units -OUS","Level 1 Fast Flow Fluid Warmer, with a circuit board component that may result in false over temperature alarm, was distributed. ",1/28/2013,"01/28/2013",3/20/2013,"03/20/2013"
"Devices",64211,"Ongoing","Smiths Medical ASD, Inc.","Rockland","MA","US","Voluntary: Firm Initiated","Letter","NationwideForeign: Canada, Mexico, Santo Domingo, Panama, Equador, Chile, Portugual, Qatar, Ireland, Libiya, UAE, Great Britain, India,Germany, Italy, Oman. Belgium, Netherlands, Switzerland, Australia, Austria, Poland, Romania, Hungary, Vietnam,Egypt, Japan, Spain","B-1051-13","Class II","Level 1 Fast Flow Fluid Warmer's without air detectionReorder Number: H-1000 100V, 115V and Level Fast Flow Fluid Warmer's without air detection 230V","Serial Numbers: S104C00013, S104C00014, S104C00015, S104C00016,S104C00019, S104C00020, S104C00021, S104C00022, S104C00023, S104C00024, S104C00025, S104C00026, S104C00027, S104C00028, S104C00029, S104C00030, S104C00031, S104C00032, S104C00033, S104C00034, S104C00035, S104C00036, S104C00037, S104C00038, S104C00039, S104C00040, S104C00041, S104C00042, S104C00043",,"29 OUS","Level 1 Fast Flow Fluid Warmer, with a circuit board component that may result in false over temperature alarm, was distributed. ",1/28/2013,"01/28/2013",3/20/2013,"03/20/2013"
"Veterinary",64212,"Ongoing","Hartz Mountain Corp.","Secaucus","NJ","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Nationwide","V-201-2013","Class II","Hartz Chicken Chews Bite Size Made in China for the Hartz Mountain Corporation, Secaucus, NJ 07094 USA Net Wt. 5.7 oz. - UPC 3270012856 Net Wt. 16 oz - UPC 3270012765 ","All codes",".","5.7 oz -7,094 units; 16 oz - 6,301 units; ","Pet treats contain unapproved antibiotics",1/25/2013,"01/25/2013",6/19/2013,"06/19/2013"
"Veterinary",64212,"Ongoing","Hartz Mountain Corp.","Secaucus","NJ","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Nationwide","V-199-2013","Class II","Hartz Oinkies Pig Skin Twists wrapped with Chicken Made in China for the Hartz Mountain Corporation, Secaucus, NJ 07094 USA and imported by Hartz Canada Inc., St. Thomas, Ontario N5P 3W7 , Canada 5 pig skin twists UPC 3270003354 7 mini pig twists UPC 3270003330 15 mini pig skin twists - 11.4 oz UPC 3270003331 20 pig skin twists - 4.9 oz. UPC 32700-13472 ","All codes",".","5 pack - 38,672 units; 7 pack - 42,258 units; 15 pack -49070 units; 20 pack - 30,912 units","Pet treats contain unapproved antibiotics",1/25/2013,"01/25/2013",6/19/2013,"06/19/2013"
"Veterinary",64212,"Ongoing","Hartz Mountain Corp.","Secaucus","NJ","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Nationwide","V-203-2013","Class II","Exer-hides Rawhide Twists Distributed by Wal-Mart Stores, Inc.. Bentonville, AR 72716 Made in China 25 pack 5'' twists. Net Wt. 6 oz. UPC 8113143905 ","All codes",".","593,420 units","Pet treats contain unapproved antibiotics.",1/25/2013,"01/25/2013",6/19/2013,"06/19/2013"
"Veterinary",64212,"Ongoing","Hartz Mountain Corp.","Secaucus","NJ","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Nationwide","V-200-2013","Class II","Hartz Chicken Chews Soft and Tender Made in China for the Hartz Mountain Corporation, Secaucus, NJ 07094 USA Net Wt. 3.5 oz. - UPC 3270011966 Net Wt. 8 oz - UPC 3270011967 Net Wt. 16 oz. - UPC 3270011953 Net Wt. 24 oz. - UPC 3270011954","All codes",".","3.5 oz. - 17610 units; 8 oz. - 26,202 units; 16 oz - 9,937 units; 24 oz. - 17,593 units","Pet treats contain unapproved antibiotics",1/25/2013,"01/25/2013",6/19/2013,"06/19/2013"
"Veterinary",64212,"Ongoing","Hartz Mountain Corp.","Secaucus","NJ","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Nationwide","V-198-2013","Class II","Hartz Oinkies wraps with Chicken Made in China for the Hartz Mountain Corporation, Secaucus, NJ 07094 USA and imported by Hartz Canada Inc., St. Thomas, Ontario N5P 3W7 , Canada 5 pig skin twists - 3.1 oz UPC 3270003354 7 mini pig skin twists - 6 oz.","All codes",".","5 pack - 38,762 units; 7 pack - 42,258 units","Pet treats contain unapproved antibiotics",1/25/2013,"01/25/2013",6/19/2013,"06/19/2013"
"Veterinary",64212,"Ongoing","Hartz Mountain Corp.","Secaucus","NJ","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Nationwide","V-202-2013","Class II","Pet Pride Chicken Breast Jerky Distributed by: The Kroger Co. Cincinnati OH, Made In China Net Wt. 16 oz. - UPC 1111087994 Net Wt. 24 oz - UPC 1111079250 ","All codes",".","16 oz. - 34,704 units; 24 oz. - 50,364 units","Pet treats contain unapproved antibiotics",1/25/2013,"01/25/2013",6/19/2013,"06/19/2013"
"Devices",64213,"Ongoing","Elekta, Inc.","Atlanta","GA","US","Voluntary: Firm Initiated","Other","Nationwide Distribution including TX","Z-0885-2013","Class II","Elekta, Apex add-on Micro MLC, collimator for radiation therapy.","152652",,"1","If the Apex collimator is incorrectly installed on the radiation head, a touchguard inhibit activates the view restrictions dialog box only shows the top 12 restrictions.",1/18/2013,"01/18/2013",3/6/2013,"03/06/2013"
"Devices",64214,"Terminated","Siemens Medical Solutions USA, Inc","Concord","CA","US","Voluntary: Firm Initiated","Letter","5 devices, all located outside of the United States in Germany.","Z-0907-2013","Class II","SIEMENS brand ARTISTE syngo RT Therapist (RTT) version 4.3, ARTISTE Model, Part No. 08162815, Digital linear accelerators, MOSAIQ OIS system, Distributed by SIEMENS Healthcare IM CR RO, CR Radiation Oncology, Manufactured by SIEMENS AG, MEDICAL SOLUTIONS, GERMANY.","All codes/units of ARTISTE model.",,"5 units","Siemens became aware of a potential safety issue when using the ''In-session resumption'' feature of the syngo RT Therapist (RTT) 4.3 software. The RTT will send again the previously completed beam or segment for delivery to the control console, thus repeating the already delivered Monitor Units of the same beam or segment.",1/17/2013,"01/17/2013",3/13/2013,"03/13/2013"
"Devices",64215,"Ongoing","Vascular Solutions, Inc.","Maple Grove","MN","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution - USA Nationwide including the states of AL, AZ, AR, CA, CO, CT, DE, CD, FL, GA, HI, ID, IL ,IN, IA, KY, LA, ME, MD, MA, MI,MN, MO, MT, NE, NV, NH, NJ, NM, NY, NC, ND, OH, OK, OR, PA, SC, SD, TN, TX, UT, VT VA, WA, WV, WI, WY and AUSTRIA, CANDA, DENMARK, FINLAND, FRANCE, GERMANY, GREECE, HUNGARY, ISRAEL,. ITALY, MEXICO, NETHERLANDS, NORWAY, SPAIN, SWEDEN, SWITZERLAND, TAIWAN, TURKEY, UNITED KINGDOM.","Z-0868-2013","Class II","Vascular Solutions, SuperCross Microcatheter, Sterilized using ethylene oxide, Rx Only, Model numbers 5300 - 5307, 5324, 5325, 5329, 5332, 5336, 5340, and 5341. Product Usage: The SuperCross catheter is intended to be used in conjunction with steerable guidewires to access discrete regions of the coronary and/or peripheral vasculature. It may be used to facilitate placement and exchange of guidewires and other interventional devices and to subselectively infuse/deliver diagnostic and therapeutic agents ","559450, 551750, 552370, 552761, 552840, 552954, 553267, 553647, 553931, 554269, 554270, 554413. 555958, 557192, 557824, 558222, 558894, 559827, 560215, 551751, 552371, 552841, 553090, 553218, 553434, 553529, 554029, 554268, 554271, 555759, 555953, 557251, 559570, 559981, 560253, 560079, 560080, 554123, 556182, 558905, 560114, 554210, 555991, 556842, 557253, 554209, 555223, 555992, 556536, 556747, 557124, 558327, 558991, 560115, 561206, 554208, 555490, 555993, 556674, 556843, 558018, 558798, 559707, 560433, 561207, 554040, 555007, 555224, 555358, 558542, 560434, 561459, 554122, 555008, 555225, 555994, 558992, 561208, 560221, 560222, 560223, 560995, 560996.",".","4731","Vascular Solutions, Inc has discovered a potential problem with a number of lots of Supercross microcatheters. A potential for surface contamination on aged catheters was observed during in-house testing. ",1/29/2013,"01/29/2013",2/27/2013,"02/27/2013"
"Devices",64216,"Ongoing","Ormco/Sybronendo","Glendora","CA","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution - USA (nationwide) and the countries of Australia, Azerbaijan, Belgium, Canada, China, Cyprus, Czech Republic, Egypt, Estonia, Finland, France, Germany, Greece, Hong Kong, Iceland, India, Italy, Japan, Kuwait, Latvia, Lebanon, Malaysia, Netherlands, New Zealand, Pakistan, Poland, Romania, Russia, Saudi Arabia, Singapore, Spain, Sweden, Switzerland, Thailand, Turkey, Ukraine, United Arab Emirates, and United Kingdom.","Z-1544-2013","Class II","SybronEndo Elements Obturation Unit; REF 973-0322; SN 91-1234; 2005-10; SybronEndo, 1332 S. Lone Hill Ave. Glendora, CA 91740; EU Rep: Kerr Italia, S.r.l, Via Passanti, 332, 1-84018 Scafati (SA), Italy The intended use of the Elements Obturation Unit and Replacement A/C Power Cord is to provide continuous heat at the tip of the dental instrument to test tooth response to thermal stimulus, for tissue cauterization and coagulation and to backfill and down pack gutta percha during endodontic root canal treatment.","Lot/Serial Numbers: 91-17011 to 91-19095; 91-20889 to 91-22339",,"3615 units total","A recall has been issued by SybronEndo because a Canadian Standards Association (CSA)-directed cautionary statement label was inadvertently omitted from the Elements Obturation Unit and its Replacement A/C Power Cord. ",1/17/2013,"01/17/2013",6/26/2013,"06/26/2013"
"Devices",64216,"Ongoing","Ormco/Sybronendo","Glendora","CA","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution - USA (nationwide) and the countries of Australia, Azerbaijan, Belgium, Canada, China, Cyprus, Czech Republic, Egypt, Estonia, Finland, France, Germany, Greece, Hong Kong, Iceland, India, Italy, Japan, Kuwait, Latvia, Lebanon, Malaysia, Netherlands, New Zealand, Pakistan, Poland, Romania, Russia, Saudi Arabia, Singapore, Spain, Sweden, Switzerland, Thailand, Turkey, Ukraine, United Arab Emirates, and United Kingdom.","Z-1545-2013","Class II","SybronEndo Replacement AC Power Cord, US Elements Obturation; REF 973-0334; SybronEndo, 1332 S. Lone Hill Ave. Glendora, CA 91740; EU Rep: Kerr Italia, S.r.l, Via Passanti, 332, 1-84018 Scafati (SA), Italy, Made in Taiwan The intended use of the Elements Obturation Unit and Replacement A/C Power Cord is to provide continuous heat at the tip of the dental instrument to test tooth response to thermal stimulus, for tissue cauterization and coagulation and to backfill and down pack gutta percha during endodontic root canal treatment.","Lot/Serial Numbers: 3757349, 4220920, 4304917, 4367699, 436513, 4445719, 4458262, 4522605, 4581118, 4724407, 4730212",,"3615 unit total","A recall has been issued by SybronEndo because a Canadian Standards Association (CSA)-directed cautionary statement label was inadvertently omitted from the Elements Obturation Unit and its Replacement A/C Power Cord. ",1/17/2013,"01/17/2013",6/26/2013,"06/26/2013"
"Biologics",64217,"Terminated","Heartland Lions Eye Bank","Kansas City","MO","US","Voluntary: Firm Initiated","Telephone","Missouri","B-0838-13","Class II","Cornea","PH109275OS; PH109275OD",".","2","Human Corneas, recovered in a manner that increased the risk of the introduction, transmission, or spread of communicable disease, were distributed.",12/6/2012,"12/06/2012",2/27/2013,"02/27/2013"
"Biologics",64218,"Terminated","Ogden Medical Center, Inc.","Ogden","UT","US","Voluntary: Firm Initiated","Telephone","NV","B-1222-13","Class II","Red Blood Cells Leukocytes Reduced","W1165123178833",".","1 unit","Blood product, which was collected from a donor who traveled to a malarial endemic area, was distributed.",9/19/2012,"09/19/2012",5/29/2013,"05/29/2013"
"Devices",64221,"Ongoing","Edwards Lifesciences, LLC","Draper","UT","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution - USA Nationwide including the states of: MD, NY, PA, CA, FL, AZ, AL, TX, VA, OH, MO, NC, GA, TN, CO, OR, SC, ME, IL, HI, NJ, WA, WI, CT, KY, LA and Canada.","Z-1322-2013","Class II","Proplege Coronary Sinus Catheter model PR9, 11 French Introducer, kitted with PR9. Product Usage: The catheter introducer sheath kit provides access to the central venous circulation to facilitate catheter and guidewire insertion. The Proplege coronary sinus catheter provides retrograde cardioplegia during cardiopulmonary by-pass surgery.","Model PR9, lot numbers: 59385159, 59385164, 59385204, 59398000, 59398006, 59398008, 59400402, 59423199, 59423200, 59385159, 59385164, 59385204, 59398000, 59398006.",,"807","Edwards Lifesciences is recalling certain Proplege Coronary Sinus Catheter, model PR9 due to confirmed reports of blood leakage through the hemostasis valve in the introducer that is kitted with the catheter.",1/25/2013,"01/25/2013",5/22/2013,"05/22/2013"
"Drugs",64223,"Ongoing","Stat Rx USA","Gainesville","GA","US","Voluntary: Firm Initiated","Telephone","PA","D-144-2013","Class III","Methocarbamol 750 mg Tablets, 90-count bottle, Mfg by: West-Ward Pharm. Corp., Eatontown, NJ 07724, Packaged and Distributed by: Stat Rx USA, NDC 42549-521-90.","A02568, Exp 01/16",,"3 bottles","Labeling: Incorrect or missing lot and/or expiration date. The product was mistakenly labeled with an expiration date of 10/16 instead of 01/16.",1/28/2013,"01/28/2013",2/13/2013,"02/13/2013"
"Devices",64226,"Ongoing","GE Healthcare, LLC","Waukesha","WI","US","Voluntary: Firm Initiated","Letter","Nationwide Distribution including NM, WY, FL, MO, MA, and MI.","Z-0761-2013","Class II","GE Healthcare Brivo XR385 DR-F/ X-Ray System X-Ray System","Model Number : 5271997",,"9 units installed in US","GE Healthcare has become aware of a software issue on the interface of the Brivo XR385 DR-F/ Model 5271997 radiographic product related to Visual indication as mandated by the US Code of Federal Regulations (21CFR) and IEC 60601-1-3.",8/3/2012,"08/03/2012",3/6/2013,"03/06/2013"
"Food",64227,"Ongoing","Penzeys LTD","Wauwatosa","WI","US","Voluntary: Firm Initiated","Telephone","MN, WI, CT, OH.","F-0978-2013","Class II","Vietnamese Cinnamon Extra Fancy, product code 43200, Penzeys Spices, Wauwatosa, WI 53222. to be completed","1454800",,"47 lbs.","Penzeys received a complaint from a customer who found pieces of glass in bulk Vietnamese Cinnamon.",1/9/2013,"01/09/2013",2/13/2013,"02/13/2013"
"Devices",64228,"Ongoing","Cellestis Inc","Santa Clarita","CA","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Worldwide distribution: USA (nationwide) and countries of: Argentina, Australia, Austria, Belgium, Bosnia and Herzegovina, Bulgaria, Czech Republic, Denmark, Estonia, Finland, France, Germany, Great Britain, Ireland, Israel, Jordan, Luxembourg, Mexico, Netherlands, New Zealand, Peru, Poland, Saudi Arabia, Slovakia, Slovenia, South Africa, Switzerland, and Turkey.","Z-0888-2013","Class II","VACUETTE Cellestis 1 ml QuantiFERON - TB ANTIGEN; Shake 10x; REF 454074; HE0105; 13X75 50 pcs.,1200 pcs. in total; Product Usage: QuantiFERON-TB Gold (QFT) is an in vitro diagnostic test using a peptide cocktail simulation ESAT-6, CFP-10 and TB7.7 (p4) proteins to stimulate cells in heparinized whole blood.","Cat # 0592-0201; Lot A111103N Exp 28 FEB, 2013",,"309,400 units","Cellestis is recalling QuantiFERON - TB Gold TB Blood Collection Tubes and HA TB Blood Collection Tubes due to potential contamination.",9/27/2012,"09/27/2012",3/6/2013,"03/06/2013"
"Devices",64228,"Ongoing","Cellestis Inc","Santa Clarita","CA","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Worldwide distribution: USA (nationwide) and countries of: Argentina, Australia, Austria, Belgium, Bosnia and Herzegovina, Bulgaria, Czech Republic, Denmark, Estonia, Finland, France, Germany, Great Britain, Ireland, Israel, Jordan, Luxembourg, Mexico, Netherlands, New Zealand, Peru, Poland, Saudi Arabia, Slovakia, Slovenia, South Africa, Switzerland, and Turkey.","Z-0889-2013","Class II","Vacuette Cellestis 1 ml QuantiFERON TB ANTIGEN (HA) High Altitude: Shake 10x; REF 454413. HE0396. greiner bio-one; 13x75 50pcs.,1200 pcs in total. Product Usage: QuantiFERON-TB Gold (QFT) is an in vitro diagnostic test using a peptide cocktail simulation ESAT-6, CFP-10 and TB7.7 (p4) proteins to stimulate cells in heparinized whole blood.","Cat # 0592-0501; Lot A111103M; Exp 28 FEB, 2013",,"29,690 units","Cellestis is recalling QuantiFERON - TB Gold TB Blood Collection Tubes and HA TB Blood Collection Tubes due to potential contamination.",9/27/2012,"09/27/2012",3/6/2013,"03/06/2013"
"Devices",64229,"Ongoing","Edwards Lifesciences, LLC","Irvine","CA","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution-USA (nationwide) including the states of AR, CA, FL, HI, ID, IN, KS, KY, LA, MA, MI, MN, MO, NC, ND, NM, NV, NY, OH, OK, PA, SD, TN, TX, VA, WA, and WI and country of: Europe.","Z-1146-2013","Class II","Pressure Monitoring sets with VAMP Plus closed blood sampling system model # T001691A, PXVP0566, PXVP2260, PXVP0826, PXVP0827, PXVP2284AT3, PXVP23X3AT3, T398807D, T100605B, T001762A, T391T00A, VP2. Blood sampling system used on patients requiring periodic withdrawal of blood samples.","59184554, 59187809, 59191725, 59221801, 59227844, 59238613, 59326333, 59356987, 59401041, 59222349, 59227178, 59234808, 59284693, 59328047, 59270408, 59284617, 59276238, 59401734, 59270380, 59319038, 59306624, 59390840, 59195810, 59331224, 59397181, 59291446, 59272771.",".","30,467","The device is being recalled because the firm has received multiple complaints related to incorrect assembly that may result in dilution of blood samples.",1/30/2013,"01/30/2013",4/24/2013,"04/24/2013"
"Devices",64231,"Ongoing","Siemens Medical Solutions USA, Inc.","Mountain View","CA","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution - USA including WV and OH; Internationally to Australia, Austria, Bahrain, Belgium, Brazil, China (P.R.) Estonia, France, Germany, Greece, India, Indonesia, Israel, Italy, Japan, Jordan, Kuwait, Lebanon, Macedonia, Malaysia, Mexico, Netherlands, Peru, Philippines, Poland, Portugal, Qatar, Rep of Korea, Romania, Sweden, Taiwan, Thailand, Turkey, Unite Arab Emirates, United Kingdom and Venezuela.","Z-0930-2013","Class II","ACUSON S2000 Automated Breast Volume Scanner (ABVS); Model number 10042541 Distributed by Siemens Medical Solutions USA Inc. business Unit: Ultrasound. The S2000 Automated Breast Volume Scanner (ABVS) Ultrasound System for imaging of the breast allows volumetric acquisition of the breast image.","Model number 10042541 - AVBS module. Note: the S2000 system part number is 10041461, however only those systems that include the ABVS module, part number 10042541 are affected. Manufactured prior to 10/30/2012.",,"214 affected devices","On some ACUSON S2000 ABVS systems, the inside of the transducer pod may contain sharp edges.",1/18/2013,"01/18/2013",3/20/2013,"03/20/2013"
"Food",64232,"Ongoing","Ocean Beauty Seafoods, LLC","Monroe","WA","US","Voluntary: Firm Initiated","Letter","Whole Market Foods in Seattle, WA","F-1036-2013","Class I","Cold-smoked salmon in a vacuum packed, clear plastic bag. Product labeled: Csea brand Cold Smoked Smoked Sockeye Trim, 2 lb., Ingredients: Sockeye Salmon, Salt, and Natural Hardwood Smoked Produced by Ocean Beauty Seafoods, LLC KEEP REFRIGERATED AT 38 DEG OR BELOW'' ","7425A2297A, 7425A2298A and 7425A2298B",,"336 pounds (2 pound packages)","A surveillance sample was found positive for Listeria monocytogenes.",1/29/2013,"01/29/2013",3/13/2013,"03/13/2013"
"Drugs",64233,"Ongoing","Teva Pharmaceuticals USA, Inc.","Sellersville","PA","US","Voluntary: Firm Initiated","Letter","Nationwide","D-193-2013","Class II","Terazosin Hydrochloride Capsules, 2 mg, packaged in a) 100-count bottles (NDC 0093-4337-01); and b) 1000-count bottles (NDC 0093-4337-10), Rx only, Manufactured in India By: Intas Pharmaceuticals Ltd., Ahmedabad, Gujarat, India - 382 210; Manufactured For: Teva Pharmaceuticals USA, Sellersville, PA 18960.","Lot # N03029, Exp 03/14",,"3,913 bottles","Presence of Foreign Tablets/Capsules: Recall is being conducted due to a foreign capsule found in one bottle.",1/23/2013,"01/23/2013",3/20/2013,"03/20/2013"
"Food",64234,"Ongoing","Whole Foods Market Pacific NW Distribution Center (PDC)","Seattle","WA","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","14 Whole Foods Market retail stores in OR and WA.","F-1227-2013","Class I","Cream cheese/cold smoked salmon (Gravlox) spread in plastic containers. A sample of product label (SELL BY and PACK DATES may differ): ''0295307 014144 LOX & CREAM CHEESE WHOLE FOODS MARKET CCOLD SMOKED SALMON (SALMON, SALT, SUGAR AND NATURAL HARDWOOD SMOKE). CREAM CHEESE (PASTEURIZED MILK AND CREAM, CHEESE CULTURE, SALT.***SELL BY 02.06.13***PACK DATE: 01.30.13***'' There is a light blue water mark behind the ingredient statement that reads: ''WHOLE FOODS MARKET'' ","PLU: 95307, UPC: 0295307 014144 Product sold before 1/29/13.",".","Distributed to14 Whole Foods Markets in WA and OR. Amounts pending.","Cold-smoked salmon trim, used to manufacture this cream cheese spread, was processed the same day as a surveillance sample was processed, that was found positive for Listeria monocytogenes.",1/29/2013,"01/29/2013",3/27/2013,"03/27/2013"
"Food",64234,"Ongoing","Whole Foods Market Pacific NW Distribution Center (PDC)","Seattle","WA","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","14 Whole Foods Market retail stores in OR and WA.","F-1228-2013","Class I","Whole bagels and half bagels w/ cream cheese/cold smoked salmon spread wrapped in plastic. An example of the whole bagel label (in part): ''0298437 003996 BAGEL FULL LOX CREAM CHEESE CAPERS BAGEL (ORGANIC WHEAT FLOUR, ORGANIC WHITE WHOLE WHEAT FLOUR, ORGANIC SUGAR, ORGANIC WHEAT GLUTEN, ORGANIC WHOLE WHEAT FLOUR, ORGANIC OAT FLOUR, YEAST, SALT, ORGANIC OAT FIBER, ORGANIC HIGH***SELL BY: 02.02.13***PACK DATE: 01.30.13***Whole Foods Market Inc., Bellevue, WA 98005***'' There is a light blue water mark behind the ingredient statement that reads: ''WHOLE FOODS MARKET'' An example of the half bagel label (in part): ''0292811 001998 HALF BAGEL WITH LOX CAPERS AND CREAM CHEESE CAPERS BAGEL (ORGANIC WHEAT FLOUR, ORGANIC WHITE WHOLE WHEAT FLOUR, ORGANIC SUGAR, ORGANIC WHEAT GLUTEN, ORGANIC WHOLE WHEAT FLOUR, ORGANIC OAT FLOUR, YEAST, SALT, ORGANIC OAT FIBER, ORGANIC HIGH OELIC SUNFLOWER OIL, ORGANIC RAISIN JUICE CONCENTRATE, ORGANIC BARLEY FLOUR, ORGANIC GUAR GUM, ORGANIC CULTURED WHEAT***SELL BY: 02.02.13***PACK DATE: 01.30.13***'' There is a light blue water mark behind the ingredient statement that reads: ''WHOLE FOODS MARKET''","Half Bagel: PLU 92811, UPC: ''0292811 001998 Whole Bagel: PLU: 98437, UPC 0298437 003996 All products sold before 1/29/13. ",".","Distributed to14 Whole Foods Markets in WA and OR. Amounts pending","Cold-smoked salmon trim, used to manufacture these bagels, processed the same day as a surveillance sample was processed that was found positive for Listeria monocytogenes.",1/29/2013,"01/29/2013",3/27/2013,"03/27/2013"
"Food",64234,"Ongoing","Whole Foods Market Pacific NW Distribution Center (PDC)","Seattle","WA","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","14 Whole Foods Market retail stores in OR and WA.","F-1226-2013","Class I","Cold-smoked salmon in plastic containers. An example of the labeling follows, however, the ''SELL BY:'' and ''PACK DATE'' changes. ''0297629 015885 SOCKEYE SALMON LOX TRIM WHOLE FOODS MARKET SALMON, SALT, SUGAR AND NATURAL HARDWOOD SMOKE. CONTAINS: FISH***SELL BY: 02.06.13***PACK DATE: 01.30.13***'' There is a light blue water mark behind the ingredient statement that reads: ''WHOLE FOODS MARKET'' ","PLU: 97629, UPC: 0297629 015885Product sold before 1/29/13.",".","Distributed to 14 Whole Foods Market stores in WA and OR. Amounts pending.","The repacked cold-smoked salmon trim was processed on the same day as a surveillance sample was processed, that was found positive for Listeria monocytogenes.",1/29/2013,"01/29/2013",3/27/2013,"03/27/2013"
"Devices",64235,"Ongoing","Medical Components, Inc dba MedComp","Harleysville","PA","US","Voluntary: Firm Initiated","Letter","USA Nationwide Distribution including the state of PA.","Z-0898-2013","Class II","REF CMS-CT6T225, 6F Triple Lumen CT PICC with M.S.T. Components Product Usage: Power injectable infusion PICC insertion kits ","Lots numbers MBKQ640, exp 05/2015; MBKZ720, exp 05/2015; MBLJ290, exp 06/2015; MBLR100, exp 07/2015; MBLZ350, exp 09/2015; and MBMG250, exp 10/2015.",,"785","This recall is being initiated due to the affected product being packaged with the incorrect introducer needle. The kit label indicates a ''safety'' needle is included; the kits were packaged with a non-safety needle.",12/13/2012,"12/13/2012",3/6/2013,"03/06/2013"
"Devices",64236,"Ongoing","Synthes USA HQ, Inc.","West Chester","PA","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution - USA including CO, PA, TN, VA, TN, WA, and internationally to Czech Republic.","Z-2282-2013","Class II","Synthes Oracle Spacer System Slap Hammer, Part Number 03.809.690, Lot Number 3723847 The Oracle Spacer is indicated for use in patients with degenerative disc disease (DDD) at one or two contiguous levels from L2 to S1 whose condition requires the use of interbody fusion combined with supplemental fixation. The Oracle Spacer is indicated as a vertebral body replacement device intended for use in the thoracolumbar spine (T1-L5) to replace a diseased vertebral body resected or excised during partial and total vertebrectomy procedures or the treatment of tumor or trauma (i.e., fracture), to achieve anterior decompression of the spinal cord and neural tissues, and to restore the height of the collapsed vertebral body. The Slap Hammer, 03.809.690, is a dual sided device with two separate attachment options. The Slap Hammer allows a user (surgeon) to remove a previously placed trial implants.","Part number 03.809.690, Lot Number 6723847",".","27","This recall is being initiated in response to complaints received where it was reported that the proximal end of the Slap Hammer broke during use.",1/11/2013,"01/11/2013",10/2/2013,"10/02/2013"
"Biologics",64237,"Terminated","LifeSource","Rosemont","IL","US","Voluntary: Firm Initiated","Telephone","IL","B-1229-13","Class II","Platelets Pheresis Leukocytes Reduced","W287012007860; W287012007860; W287012007897; W287012007897; W287012007912; W287012007936; ",".","6 units","Blood products, which did not meet the acceptable product specifications, were distributed.",12/11/2012,"12/11/2012",5/29/2013,"05/29/2013"
"Biologics",64238,"Terminated","ONEBLOOD Inc DBA: Southeastern Comm. Blood Center","Tallahassee","FL","US","Voluntary: Firm Initiated","Telephone","FL","B-1220-13","Class III","Red Blood Cells Leukocytes Reduced","W12701283116500",".","1 unit","Blood product, collected from a therapeutic donor, was distributed.",12/21/2012,"12/21/2012",5/29/2013,"05/29/2013"
"Biologics",64239,"Terminated","The American National Red Cross - Southern Region","Douglasville","GA","US","Voluntary: Firm Initiated","Telephone","GA","B-1234-13","Class III","Platelets Pheresis Leukocytes Reduced Irradiated","03KE41985",".","1 unit","Blood products, stored at unacceptable storage temperatures, were distributed.",12/5/2012,"12/05/2012",5/1/2013,"05/01/2013"
"Biologics",64239,"Terminated","The American National Red Cross - Southern Region","Douglasville","GA","US","Voluntary: Firm Initiated","Telephone","GA","B-1235-13","Class III","Platelets Pheresis Leukocytes Reduced","003KE42042; 003KE42043; 003KE42045; 03KE41985; 03KE41986; 03KE41987; 03KE41987; 03KE42029; 03KE42030; ",".","9 units","Blood products, stored at unacceptable storage temperatures, were distributed.",12/5/2012,"12/05/2012",5/1/2013,"05/01/2013"
"Biologics",64240,"Terminated","LifeShare Blood Centers","Shreveport","LA","US","Voluntary: Firm Initiated","Letter","TX","B-1221-13","Class II","Red Blood Cells Leukocytes Reduced","W036512122190",".","1 unit","Blood product, collected from a donor who traveled to a malarial endemic area, was distributed. ",1/11/2013,"01/11/2013",5/1/2013,"05/01/2013"
"Biologics",64241,"Terminated","Community Blood Center Of Gtr KC","Kansas City","MO","US","Voluntary: Firm Initiated","FAX","KS","B-1225-13","Class III","Red Blood Cells (Apheresis) Leukocytes Reduced","W045011067606-part 1; W045011067606-part 2 ",".","2 units","Blood products, collected from a donor who was at risk for Leishmaniasis, were distributed.",12/18/2012,"12/18/2012",5/29/2013,"05/29/2013"
"Devices",64242,"Completed","GE Healthcare, LLC","Waukesha","WI","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution - USA including AL, AZ, AR, CA, CO, CT, FL, GA,IL,IN, IA, KS, KY,LA, MD, MA, MI, M, MO, NE, NE,NJ, NM, NY, NC, OH, OK PA, SC, TN, TX, UT, VA, WI. Internationally to UNITED KINGDOM, UNITED ARAB EMIRATES, TURKEY, THAILAND, SWITZERLAND, SWEDEN, SPAIN, SOUTH AFRICA, SLOVENIA, SLOVAKIA, SINGAPORE, SAUDI ARABIA, ROMANIA, PORTUGAL, POLAND, PERU, NORWAY, NEW ZEALAND, NETHERLAND, MALAYSIA, LITHUANIA, KUWAIT, JAPAN, ITALY, ISRAEL, IRELAND, INDIA, ICELAND, HONG KONG, GERMANY, FRANCE, FINLAND, EGYPT, DENMARK, CZECH REPUBLIC, COLOMBIA, CHILE, CANADA, BELGIUM BAHRAIN, AUSTRIA, AUSTRALIA.","Z-0823-2013","Class II","GE Healthcare, CARESCAPE Monitor B650. The CARESCAPE Monitor B650 is a multi-parameter patient monitor intended for use in multiple areas and intra-hospital transport within a professional healthcare facility. The CARESCAPE Monitor B650 is intended for use on adult, pediatric, and neonatal patients and on one patient at a time. ","SERIAL NUMBER SEW1181782HA SEW11243524HA SEW11223123HA SEW11223122HA SEW11223121HA SEW11223108HA SEW11223107HA SEW11223106HA SEW11223092HA SEW11223086HA SEW11223085HA SEW11223082HA SEW11223070HA SEW11223022HA SEW11223019HA SEW11223011HA SEW11222999HA SEW11222997HA SEW11202780HA SEW11202778HA SEW11202775HA SEW11202753HA SEW11202750HA SEW11202749HA SEW11202746HA SEW11202745HA SEW11202744HA SEW11202742HA SEW11202741HA SEW11202740HA SEW11202739HA SEW11202737HA SEW11202736HA SEW11202717HA SEW11202716HA SEW11202715HA SEW11202713HA SEW11202712HA SEW11202711HA SEW11202709HA SEW11202708HA SEW11202706HA SEW11202705HA SEW11202704HA SEW11202703HA SEW11202702HA SEW11202700HA SEW11202697HA SEW11202690HA SEW11202687HA SEW11202682HA SEW11202401HA SEW11202400HA SEW11202399HA SEW11202398HA SEW11202397HA SEW11202395HA SEW11202394HA SEW11202390HA SEW11202385HA SEW11202384HA SEW11202383HA SEW11202381HA SEW11202379HA SEW11202378HA SEW11202370HA SEW11202369HA SEW11202368HA SEW11202366HA SEW11202363HA SEW11202362HA SEW11202361HA SEW11202360HA SEW11202359HA SEW11202358HA SEW11202357HA SEW11202353HA SEW11202352HA SEW11202351HA SEW11202348HA SEW11202347HA SEW11202341HA SEW11202340HA SEW11202338HA SEW11202337HA SEW11202336HA SEW11202334HA SEW11202332HA SEW11202331HA SEW11202329HA SEW11202328HA SEW11202325HA SEW11202323HA SEW11202322HA SEW11202320HA SEW11202317HA SEW11202313HA SEW11202310HA SEW11202309HA SEW11202307HA SEW11202301HA SEW11202299HA SEW11202298HA SEW11202296HA SEW11202294HA SEW11202291HA SEW11202290HA SEW11202288HA SEW11202287HA SEW11202286HA SEW11202283HA SEW11202220HA SEW11202203HA SEW11202202HA SEW11181949HA SEW11181947HA SEW11181943HA SEW11181941HA SEW11181936HA SEW11181925HA SEW11181923HA SEW11181920HA SEW11181919HA SEW11181908HA SEW11181895HA SEW11181892HA SEW11181886HA SEW11181882HA SEW11181857HA SEW11181848HA SEW11181828HA SEW11181823HA SEW11181813HA SEW11181797HA SEW11181792HA SEW11181790HA SEW11181788HA SEW11181787HA SEW11181785HA SEW11181782HA SEW11181781HA SEW11181778HA SEW11181776HA SEW11181775HA SEW11181774HA SE"," SEW10467061HA SEW10467060HA SEW10467059HA SEW10467057HA SEW10467056HA SEW10467055HA SEW10467054HA SEW10467053HA SEW10467051HA SEW10467050HA SEW10467049HA SEW10467048HA SEW10467047HA SEW10467045HA SEW10467043HA SEW10467042HA SEW10467041HA SEW10467040HA SEW10467039HA SEW10467036HA SEW10467035HA SEW10467034HA SEW10467033HA SEW10467032HA SEW10467031HA SEW10467030HA SEW10467029HA SEW10467028HA SEW10467027HA SEW10467026HA SEW10467025HA SEW10467024HA SEW10467023HA SEW10467022HA SEW10467021HA SEW10467020HA SEW10467019HA SEW10467018HA SEW10467015HA SEW10467011HA SEW10456885HA SEW10456884HA SEW10456882HA SEW10456881HA SEW10456880HA SEW10456879HA SEW10456878HA SEW10456877HA SEW10456876HA SEW10456872HA SEW10456871HA SEW10456870HA SEW10456869HA SEW10456868HA SEW10456867HA SEW10456865HA SEW10456864HA SEW10456862HA SEW10456861HA SEW10456858HA SEW10456854HA SEW10456853HA SEW10456852HA SEW10456851HA SEW10456847HA SEW10456841HA SEW10456836HA SEW10456833HA SEW10456832HA SEW10456831HA SEW10456830HA SEW10456829HA SEW10456827HA SEW10456826HA SEW10456825HA SEW10456824HA SEW10456823HA SEW10456822HA SEW10456821HA SEW10456820HA SEW10456819HA SEW10456818HA SEW10456817HA SEW10456816HA SEW10456815HA SEW10456814HA SEW10456813HA SEW10456809HA SEW10456802HA SEW10446480HA SEW10446470HA SEW10446469HA SEW10446444HA SEW10405740HA SEW10405739HA SEW10405738HA SEW10405736HA SEW10405735HA SEW10405734HA SEW10405732HA SEW10405731HA SEW10405719HA SEW10405718HA SEW10405717HA SEW10405716HA SEW10405715HA SEW10405714HA SEW10405713HA SEW10405712HA SEW10405710HA SEW10405708HA SEW10405679HA SEW10405678HA SEW10405672HA SEW10405657HA SEW10405647HA SEW10405641HA SEW10393703HA SEW10393702HA SEW10393700HA SEW10393695HA SEW10393667HA SEW10354737HA SEW10354734HA SEW11223067HA SEW11181799HA SEW11181789HA SEW11171487HA SEW11171483HA SEW11171458HA SEW11151224HA SEW11141083HA SEW11109995HA SEW11059111HA SEW11059095HA SEW11059088HA SEW11059087HA SEW11059086HA SEW11059080HA SEW11059057HA SEW11018540HA SEW11018532HA SEW10517998HA SEW10517995HA SEW10507800HA SEW10507799HA ","2813","GE Healthcare has become aware of potential issues associated with the CARESCAPE Monitor B650. There have been no reported illnesses or injuries that have occurred with the use of the device.",9/30/2011,"09/30/2011",2/20/2013,"02/20/2013"
"Food",64243,"Terminated","Tumalo Farms LLC","Bend","OR","US","Voluntary: Firm Initiated","Telephone","WA and OR only","F-1000-2013","Class II","A soft chevre-style cheese. Label reads in part, ''*** TUMALO FARMS Artisan Cheeses of Central Oregon Chevita This fresh and mild, soft, white cheese has a great tangy finish www.tumalofarms.com *** Ingredients . Pasteurized Goats' Milk, Culture, Rennet and Salt.''","Product is coded with a ''born on date'' and weight (individual cheese packages are different weight. The product also has a packaged date, which is the same as the ship date. there are 2 born on dates - 1/10/13 and 1/24/13",".","From production date 1/10/13 10 - 4 oz tubs and 4-2 lb tubs; from production date 1/24/13 3 4 oz tubs and 8 2 lb tubs","Improperly pasteurized.",1/31/2013,"01/31/2013",2/27/2013,"02/27/2013"
"Food",64243,"Terminated","Tumalo Farms LLC","Bend","OR","US","Voluntary: Firm Initiated","Telephone","WA and OR only","F-0999-2013","Class II","A soft brie-style cheese called Jewell. Ingredients: Certified organic cows' milk, Pasteurized farmstead goats' milk, cultures, rennet and salt. (information obtained from firm's web site)","Packages are labeled with a ''born on date'' along with the weight of the package. The cheeses range in weight. The package also contains a packaged date which represents the date shipped.",".","222 - 6 oz pucks ","Improperly pasteurized.",1/31/2013,"01/31/2013",2/27/2013,"02/27/2013"
"Devices",64244,"Ongoing","Ventana Medical Systems Inc","Oro Valley","AZ","US","Voluntary: Firm Initiated","Letter","Worldwide distribution: USA (nationwide) and country of: Germany.","Z-0833-2013","Class II","VENTANA (a member of the Roche Group) BenchMark ULTRA; REF/MU 750-600; Research Use Only Product Usage: Research Use Only-The DISCOVERY ULTRA Advanced Staining System is intended to automatically stain histological or cytological specimens on microscope slides with specific inununohistochemistry or in situ hybridization reagents. ","Cat#750-600; PN 05342716001; Serial #'s: 310724, 310735, 311187, 312055, 310373, 311052, 311171, 311953, 310750, 311266, 311267, 311564, 311565, 311596, 311304, 310481, 311924, 310607, 311627, 310527, 311436, 311742, 310132, 311432, 310034, 310408, 310687, 310697, 311343, 311958, 310728, 310778, 311991, 312070, 310471, 311326, 311952, 310103, 310777, 311446, 310924, 311303, 311528, 310490, 310913, 311529, 311494, 310139, 310281, 310465, 310275, 310617, 310665, 310716, 311853, 311871, 312137, 312101, 310240, 310237,310238, 311571, 311404, 310356, 310023, 312164, 312165, 310065, 310231, 310711, 310706, 310707, 310703, 311509, 310330, 310633, 311811, 311810, 310977, 311194, 311198, 310208, 310732, 310740, 310187, 311462, 311935, 310145, 311037, 310346, 310585, 310694, 310699, 310701, 310702, 310705, 310709, 310710, 310704, 311106, 311110, 311111, 311419, 311484, 311527, 310345, 311381, 311353, 310480, 311869, 311921, 311458, 310315, 310412, 311988, 310618, 310397, 310399, 311868, 311919, 312139, 312141, 312142, 311270, 310069, 311466, 311929, 310083, 310094, 310154, 311904, 310588, 312098, 312100, 310814, 311731, 311783, 311785, 312096, 312104, 312153, 310227, 310781, 310174, 311403, 311080, 311081, 311121, 311122, 311169, 311188, 311189, 311190, 311242, 311245, 311298, 311926, 310403, 310718, 311416, 311417, 312105, 312112, 310796, 310832, 310824, 311135, 311248, 312066, 310895, 310267, 310272, 311481, 311771, 311772, 310882, 311186, 311937, 310344, 311439, 311505, 310146, 310506, 311545, 310446, 310312, 311584, 312124, 310839, 311319, 311261, 310070, 310508, 311367, 311578, 311576, 311629, 311601, 311600, 311607, 311603, 311602, 311606, 311598, 311597, 311604, 311605, 311599, 311272, 312145, 312123, 310339, 310455, 310472, 310478, 310482, 311562, 311560, 311923, 311498, 311814, 311813, 311804, 310020, 310844, 311313, 311533, 310779, 311241, 311750, 310268, 310331, 311221, 311036, 311034, 311035, 310201, 310321, 310792, 312056, 311147, 311153, 311315, 311308, 310641, 310678, 310878, 310032, 311774, 311182, 31039",".","1735 instruments","Potiential for a waste fluid overflow condition to accur while running decontamination cycles on the BenchMark ULTRA automated staining platform or the DISCOVERY ULTRA automated staining platform. This type of overflow event can lead to migration of fluid across tubing and wiring within the instrument cabinet resulting in contact with electrical circuitry. This may create shorting conditions and ultimately damage and failure of the component.",9/28/2012,"09/28/2012",8/14/2013,"08/14/2013"
"Devices",64244,"Ongoing","Ventana Medical Systems Inc","Oro Valley","AZ","US","Voluntary: Firm Initiated","Letter","Worldwide distribution: USA (nationwide) and country of: Germany.","Z-0834-2013","Class II","VENTANA (a member of the Roche Group) DISCOVERY ULTRA; REF/MU 750-601; Research Use Only Product Usage: Research Use Only-The DISCOVERY ULTRA Advanced Staining System is intended to automatically stain histological or cytological specimens on microscope slides with specific inununohistochemistry or in situ hybridization reagents. ","Cat#750-601; PN 05987750001; Serial #'s: 310646, 311573, 310477, 311725, 311042, 311623, 312032, 312159, 310615, 310837, 311862, 311043 311572, 311766, 310526, 311011, 311185, 311723, 312082, 310635, 311574, 312084, 310636, 310835, 311179, 310493, 311183, 311769, 311930, 311962, 311963, 310437, 311965, 310997, 311726, 311620, 311512, 311526, 312083, 310468, 310759 (All serial numbers in the market).",".","54 instruments","Potential for a waste fluid overflow condition to accur while running decontamination cycles on the BenchMark ULTRA automated staining platform or the DISCOVERY ULTRA automated staining platform.The waste fluid drainage system may become restricted by build-up of debris in the tubing and in-line filter, thereby inhibiting optimal flow rates. This type of overflow event can lead to migration of fluid across tubing and wiring within the instrument cabinet resulting in contact with electrical circuitry. This may create shorting conditions and ultimately damage and failure of the component.",9/28/2012,"09/28/2012",8/14/2013,"08/14/2013"
"Food",64245,"Ongoing","Aptalis Pharma Us Inc","Birmingham","AL","US","Voluntary: Firm Initiated","Letter","Nationwide, Italy, Canada, and Brazil","F-1008-2013","Class II","SourceCF(R) Pediatric Drops, Multivitamins with A, B, D, E and K Plus Zinc, 2 FL OZ. (60ML), NDC 66212-300-60, UPC 668212300600","1BA67, exp Mar 13; 1DC02, exp Jun 13; 2BA86, exp Apr 14; 2FA92, exp Aug13.",,"14439 units","The data suggests that the formulation does not support the shelf life of the product as labeled.",2/4/2013,"02/04/2013",3/6/2013,"03/06/2013"
"Devices",64246,"Ongoing","Ansell Healthcare Products LLC","Iselin","NJ","US","Voluntary: Firm Initiated","Letter",".Nationwide Distribution including the states of AL, AZ, CA, CO, DE, FL, GA, IA, IN, IL, KS, KY, LA, MI, MN, MO.MS, NC, NH, NJ, NY, OH, OR, PA, RI, SC, TN, TX, VA, WI and UT.","Z-0838-2013","Class II","LifeStyles ZERO 10 uber-thin lubricated latex condoms. Mfd. for Ansell Healthcare Products LLC, Dothan, AL 96303. A sheath which completely covers the penis with a closely fitting membrane. The condom is used for contraceptive and for prophylactic purposes (preventing transmission of sexually transmitted infections). ","Zero Regular 10-Ct: SKU# 0-70907-20510-5 Master Case: 30070907205106. ",".","469,134 units ","Out of an abundance of caution, Ansell is implementing a voluntary recall of the Zero Latex Condom (regular) product. The condom has met or exceeded test and quality standards required by the Food and Drug Administration. However, we are experiencing a number of complaints concerning the difficulty in unrolling and subsequent breakage, and so we are asking to have all products returned. ",1/14/2013,"01/14/2013",2/27/2013,"02/27/2013"
"Devices",64248,"Ongoing","ConMed Corporation","Utica","NY","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution-USA (nationwide) and the countries of China, Dubai and Indonesia.","Z-0827-2013","Class II","ELECTROLASE(R) HYFRECATOR(R) ELECTRODES - BLUNT, REF/Catalog Number 7-101-8BX, Disposable Hyfrecator(R) Tips, Sterile, Rx Only --- CONMED CORPORATION 525 FRENCH RD., UTICA, NY 13502-5994 USA. Intended to be used as active RF electrodes for desiccation, fulguration and coagulation.","Beginning Lot Code 120628X, Ending Lot Code 120917X. [Lot codes on boxes and packaging contain a lot code in the following format: 120917X where 12 represents the year (2012), 09 represents the month (September), 17 represents the day of the month, and X represents the manufacturing shift code (1, 2, 3, 4,5,6 or 9)].",".","Domestic Distribution: 97,450 units; Foreign Distribution: 6,800 units ","ConMed received complaints of some devices which had broken through the seal of the sterile pouch. ConMed confirmed instances where the pouch seal was compromised on the affected products. ",1/28/2013,"01/28/2013",2/27/2013,"02/27/2013"
"Devices",64248,"Ongoing","ConMed Corporation","Utica","NY","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution-USA (nationwide) and the countries of China, Dubai and Indonesia.","Z-0826-2013","Class II","ELECTROLASE HYFRECATOR(R) ELECTRODES - SHARP, REF/Catalog Number 7-100-8BX, Disposable Hyfrecator(R) Tips, Sterile, Rx Only --- CONMED CORPORATION 525 FRENCH RD., UTICA, NY 13502-5994 USA. Intended to be used as active RF electrodes for desiccation, fulguration and coagulation.","Beginning Lot Code 120628X, Ending Lot Code 120917X. [Lot codes on boxes and packaging contain a lot code in the following format: 120917X where 12 represents the year (2012), 09 represents the month (September), 17 represents the day of the month, and X represents the manufacturing shift code (1, 2, 3, 4,5,6 or 9)].",".","Domestic Distribution: 97,450 units; Foreign Distribution: 6,800 units ","ConMed received complaints of some devices which had broken through the seal of the sterile pouch. ConMed confirmed instances where the pouch seal was compromised on the affected products. ",1/28/2013,"01/28/2013",2/27/2013,"02/27/2013"
"Devices",64250,"Ongoing","Baylis Medical Company Inc.","Mississauga","ON","CA","Voluntary: Firm Initiated","Letter","International distribution to the country of Australia.","Z-0879-2013","Class II","BMC RF Cannula Curved Sharp RadiOpaque, Non-Pyrogenic, Active Tip: 10mm, Gauge 16 Ga, Length: 100mm. The BMC RF Cannula is sealed in a Tyvek pouch (primary packaging) and then placed into a white shelf-box (secondary packaging) with the instructions for use. A predetermined number of white shelf-boxes are then placed into shipping cartons (tertiary packaging). The BMC RF Cannula is intended for use in radiofrequency heat lesion procedures for relief of pain. ","Device Model #: 1 PMF 16-145-10CS. Lot number: PFFB 190811.",,"1780","A report of an event was received indicating that upon opening a box containing 10 sterile cannula by a nurse, the pouch package of 5 of the 10 individually packaged cannula had not been sealed along one edge. Thus the pouch was open and the device could fall out of the pouch and on to the floor when retrieved from the shelf box. The cannulas were not used on any patients, as the unsealed packages were identified prior to use.",10/4/2012,"10/04/2012",3/6/2013,"03/06/2013"
"Biologics",64252,"Terminated","LifeServe Blood Center","Des Moines","IA","US","Voluntary: Firm Initiated","FAX","FL","B-1226-13","Class III","Blood and Blood Products for Reprocessing","W037912183934; W037912163660; W037912139385",".","3 unit","Blood products, which was collected from a donor in which donor suitability was not adequately determined, were distributed.",1/11/2013,"01/11/2013",5/29/2013,"05/29/2013"
"Biologics",64253,"Terminated","Ortho Clinical Diagnostics Inc","Raritan","NJ","US","Voluntary: Firm Initiated","Letter","Colombia","B-0963-13","Class III","Rho(D) Immune Globulin (Human)","RVP187D1",,"10 RhoGAM syringes","RhoGAM syringes, with lack of assurance of proper temperature monitoring during shipment, were distributed.",12/13/2012,"12/13/2012",2/20/2013,"02/20/2013"
"Biologics",64254,"Terminated","Virginia Blood Services","Richmond","VA","US","Voluntary: Firm Initiated","E-Mail","VA","B-1228-13","Class II","Platelets Pheresis Leukocytes Reduced","W087612063608",".","1 unit","Blood products, which did not meet the acceptable product specifications, were distributed.",1/25/2013,"01/25/2013",5/29/2013,"05/29/2013"
"Biologics",64255,"Terminated","Aurora Area Blood Bank Dba Heartland Blood Centers","Aurora","IL","US","Voluntary: Firm Initiated","Letter","IL","B-1227-13","Class II","Red Blood Cells Leukocytes Reduced","W0397126194597",".","1 unit","Blood product, collected from a donor who was at risk for HIV Group O, was distributed.",12/14/2012,"12/14/2012",5/29/2013,"05/29/2013"
"Devices",64256,"Ongoing","Medtronic Navigation, Inc.","Littleton","MA","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution - USA Nationwide and the countries of: Canada, AUSTRIA, BELGIUM, BRAZIL, BULGARIA, CHILE, CHINA, CROATIA, CZECH REPUBLIC, DENMARK,FINLAND, FRANCE, GERMANY, GREECE, INDIA, IRELAND, ISRAEL, ITALY, JAPAN ,KOREA, REPUBLIC OF KUWAIT, LEBANON, LIBYAN ARAB JAMAHIRIYA, MEXICO, NETHERLANDS, New Zealand, POLAND, RUSSIAN FEDERATION, SAUDI ARABIA, SINGAPORE, SLOVAKIA, SOUTH AFRICA, SPAIN, SWEDEN, SWITZERLAND, Taiwan(R.O.C.) , THAILAND, TURKEY, UNITED ARAB EMIRATES. and UNITED KINGDOM.","Z-0926-2013","Class II","Medtronic O-arm Imaging System Product Usage: image-intensified fluoroscopic x-ray system, mobile ","Product Catalog Numbers: 9732719, 9732719R, 9733346, 9733346R, BI-700-00027, BI-700-00027R, BI-700-00027-GER, BI-700-00027-GERR, BI-700-00027-100, BI-700-00027-100R, BI-700-00027-120, BI-700-00027-120R, BI-700-00027-230, BI-700-00027-230R Units with serial numbers 101 through 564 and unit 580 are affected. Serial numbers 565 and higher are not affected . ",,"463 units","Potential failure of the braking system that controls the O-arm Imaging System gantry movement in the vertical direction",1/31/2013,"01/31/2013",3/20/2013,"03/20/2013"
"Food",64257,"Ongoing","R-Kane Products Inc.","Pennsauken","NJ","US","Voluntary: Firm Initiated","Letter","Nationwide","F-1056-2013","Class II","Z Pro 25 High Protein Supplement Net. Wt. 1.3 oz. - Vanilla Flavor Formulated and Distributed by: R-Kane Products, Inc. 8351 National Highway, Pennsauken, NJ 08110 ","All codes distributed between 1/1/2011 and 1/24/2013",,"unavailable","Z Pro High Protein Vanilla Flavor Supplement is under recall because it contains the allergens milk and coconut, a tree nut, which are not declared on the label of the individual packets of the product.",1/30/2013,"01/30/2013",3/13/2013,"03/13/2013"
"Food",64257,"Ongoing","R-Kane Products Inc.","Pennsauken","NJ","US","Voluntary: Firm Initiated","Letter","Nationwide","F-1057-2013","Class II","Z Pro 25 High Protein Supplement Net. Wt. 1.5 oz. - Chocolate Flavor Formulated and Distributed by: R-Kane Products, Inc. 8351 National Highway, Pennsauken, NJ 08110 ","All codes distributed between 1/1/2011 and 1/24/2013",,,"Z Pro High Protein Chocolate Flavor Supplement is under recall since it contains milk and soy, allergens, which are not declared on the label of the individual packets of the product.",1/30/2013,"01/30/2013",3/13/2013,"03/13/2013"
"Devices",64259,"Ongoing","Philips Medical Systems (Cleveland) Inc","Cleveland","OH","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution - USA including the states of AL, AT, AZ, BAH, CA, CO, CT, DC, FL, GA, HI, IA, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, NJ, NV, NY, OH, OR, PA, PR, PR, SC, TN, TX, VA, VT, WA, WI & WV. and the countries of Albania, Algeria, Argentina, Australia, Austria, Bahrain, Bangladesh, Belgium, Bolivia, Brazil, Brunei Darussalam, Bulgaria, Canada, Chile, China, Columbia, Costa Rica, Croatia, Cyprus, Czech Republic, Denmark, Dominican, Republic, Ecuador, Egypt, Ethiopia, Finland, France, French Polynesia, Gabon, Georgia, Germany, Greece, Guadeloupe, Guinea, Hong Kong, Hungary, Iceland, India, Indonesia, Iran, Iraq, Ireland, Israel, Italy, Japan, Jordan, Kazakhstan, Kuwait, LAO People's Dem, Rep., Latvia, Lebanon, Libyan Arab Jamahiriya, Lithuania, Malawi, Malaysia, Malta, Martinique, Mexico, Netherlands, Netherlands, Netherlands Antilles, New Caledonia, New Zealand, Nigeria, Norway, Oman, Pakistan, Palestine, Panama, Peru, Philippines, Poland, Portugal, Qatar, Reunion, Romania, Russia, Saudi Arabia, Singapore, Slovakia, Slovenia, South Africa, South Korea, Spain, Sudan, Sweden, Switzerland, Syrian Arab Republic, Taiwan, Tanzania, Thailand, Tunisia, Turkey, Uganda, Ukraine, United Arab Emirates, United Kingdom, Uzbekistan, Venezuela & Viet Nam.","Z-0906-2013","Class II"," Philips Medical System Extended Brilliance Workspace (EBW), Computed Tomography X-Ray System. The Extended Brilliance Workspace (EBW) is a component of the Computed Tomography X-Ray System that is intended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission data taken at different angles and planes. This device may include signal analysis and display equipment, patient, and equipment supports, components and accessories. ","Model 728260, Serial #, 3467,5610,6151,6204,6209,6221,6437,6483,6543,6636,6658,6717,6788,6865,7154,7186,7253,7470, 7507,7576,7579,7639,7690,7692,7708,7835,7977,8099,8255,8332,8443,8756,8757,8890,8922,9079, 9201,9395,9422,10085,10086,10090,10102,10138,10155,10180,10197,10216,10240,10261,10264,10271, 10312, 10324,10328,10346,10355,10359,10378,10383,10389,10422,10427,10431,10435,10437,10442, 10455,10456,10470,10476,10492,10537,10547,10561,10584,10598,10604,10606,10622,10630,10646, 10672,10686,10699,10722,10727,10738,10745,10747,10770,10776,10778,10796,10798,10817,10821, 10822,10823,10838,10841,10874,10889,10890,10897,10952,10953,10965,10980,10985,10988,10998, 11007,11010,11025,11036,11037,11043,11051,11054,11058,11062,11065,11080,11083,11085,11086, 11088,11089,11105,11107,11113,11121,11127,11128,11140,11141,11147,11148,11149,11151,11152, 11153,11166,11169,11173,11174,11208,11221,11230,11232,11241,11243,11260,11262,11267,11274, 11278,11280,11282,11291,11314,11317,11324,11334,11339,11341,11557,11561,11564,11567,11572, 11577,11581,11585,11603,11610,11612,11620,11622,11630,11631,11633,11644,11649,11650,11656, 11657,11659,11660,11662,11663,11667,11668,11670,11673,11674,11684,11685,11692,11694,11696, 11699,11700,11703,11706,11708,11711,11714,11717,11718,11720,11729,11739,11740,11742,11743, 11744,11745,11747,11748,11749,11750,11751,11753,11754,11755,11756,11758,11760,11762,11765, 11766,11768,11769,11770,11772,11773,11774,11776,11779,11780,11781,11782,11784,11785,11788, 11790,11791,11793,11794,11795,11796,11797,11798,11800,11801,11802,11803,11804,11805,11806, 11807,11808,11809,11810,11812,11813,11814,11816,11817,11818,11819,11822,11823,11830,11831, 11832,11833,11834,11838,11839,11840,11841,11842,11843,11844,11845,11846,11847,11848,11850, 11851,11852,11854,11856,11858,11859,11862,11863,11864,11865,11866,11868,11869,11870,11873, 11874,11877,11878,11879,11880,11881,11882,11883,11884,11885,11886,11888,11889,11890,11891, 11892,11893,11896,11897,11898,11899,11900,11901,11902,11903,11904,11905,11906,11907,11911, 11912,11913,119",,"2,580 units","Incorrect values may be displayed. Philips is issuing a software update (version 4.5.5) to the Extended Brilliance Workspace (EBW) systems currently running software version(s) 4.0.2, V4.5.2 or V4.5.3, addressing a number of non-conformances.",9/28/2012,"09/28/2012",3/13/2013,"03/13/2013"
"Devices",64263,"Ongoing","Hospira Inc.","Lake Forest","IL","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution - USA (nationwide) including states of: AK, AL, AR, AZ, CA, CO, CT, DE, FL, GA, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV, WY, District of Columbia, Puerto Rico and U.S. Virgin Islands; and countries of: Costa Rica and Dominican Republic.","Z-0287-2014","Class II","The Plum A+ Infusion System is a cassette based multifunction infusion system that allows two lines in and one line out and can be used for standard, piggyback, or concurrent delivery. The Plum A+ Infusion System is designed to deliver parenteral, enteral, or epidural infusions over a broad range of infusion rates from multiple fluid container types. The Plum A+ Infusion System includes an infuser, disposable IV sets (hereafter called a set), optional accessories, and this operator's manual. The Plum A+ Infusion System with Hospira MedNet Software is indicated for use in parenteral, enteral and epidural therapies and the administration of whole blood and blood products.","Excessive data in the Code Information for this product has caused issues with the CSV download function. The complete list of Code Information can be found at the Addendum to Enforcement Report.",".","182,971 units","Plum A+ infusers have the potential for the distal (occlusion) press sensor pin to break. The distal pressure sensor pin is a part of the overall subsystem that measures the pressure within the distal line of the administration set and indicates the presence of a full or partial distal occlusion. A broken distal pin can only be detected via a visual inspection of the distal pressure pin. A broken distal pressure pin could result in incorrect distal pressure readings, undetected distal occlusions and/or undetected cassette failures.",2/1/2013,"02/01/2013",11/20/2013,"11/20/2013"
"Devices",64263,"Ongoing","Hospira Inc.","Lake Forest","IL","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution - USA (nationwide) including states of: AK, AL, AR, AZ, CA, CO, CT, DE, FL, GA, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV, WY, District of Columbia, Puerto Rico and U.S. Virgin Islands; and countries of: Costa Rica and Dominican Republic.","Z-0284-2014","Class II","The Plum A+ Infusion System is a cassette based multifunction infusion system that allows two lines in and one line out and can be used for standard, piggyback, or concurrent delivery. The Plum A+ Infusion System is designed to deliver parenteral, enteral, or epidural infusions over a broad range of infusion rates from multiple fluid container types. The Plum A+ Infusion System includes an infuser, disposable IV sets (hereafter called a set), optional accessories, and this operator's manual. The Plum A+ Infusion System with Hospira MedNet Software is indicated for use in parenteral, enteral and epidural therapies and the administration of whole blood and blood products.","Excessive data in the Code Information for this product has caused issues with the CSV download function. The complete list of Code Information can be found at the Addendum to Enforcement Report.",".","10,669 units","Plum A+ infusers have the potential for the distal (occlusion) press sensor pin to break. The distal pressure sensor pin is a part of the overall subsystem that measures the pressure within the distal line of the administration set and indicates the presence of a full or partial distal occlusion. A broken distal pin can only be detected via a visual inspection of the distal pressure pin. A broken distal pressure pin could result in incorrect distal pressure readings, undetected distal occlusions and/or undetected cassette failures.",2/1/2013,"02/01/2013",11/20/2013,"11/20/2013"
"Devices",64263,"Ongoing","Hospira Inc.","Lake Forest","IL","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution - USA (nationwide) including states of: AK, AL, AR, AZ, CA, CO, CT, DE, FL, GA, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV, WY, District of Columbia, Puerto Rico and U.S. Virgin Islands; and countries of: Costa Rica and Dominican Republic.","Z-0285-2014","Class II","The Plum A+ Infusion System is a cassette based multifunction infusion system that allows two lines in and one line out and can be used for standard, piggyback, or concurrent delivery. The Plum A+ Infusion System is designed to deliver parenteral, enteral, or epidural infusions over a broad range of infusion rates from multiple fluid container types. The Plum A+ Infusion System includes an infuser, disposable IV sets (hereafter called a set), optional accessories, and this operator's manual. The Plum A+ Infusion System with Hospira MedNet Software is indicated for use in parenteral, enteral and epidural therapies and the administration of whole blood and blood products.","1) List Number 11973; Serial Numbers: 12570148 , 12570150 , 12570154 , 12570163 , 12570170 , 12570177 , 12570204 , 12570211 , 12570212 , 12570255 , 12570270 , 12570319 , 12570359 , 12570385 , 12570413 , 12570425 , 12570455 , 12570487 , 12570662 , 12570695 , 12570854 , 12570915 , 12571080 , 12571243 , 12571437 , 12571631 , 12571692 , 12571776 , 12571826 , 12571835 , 12571837 , 12571842 , 12571877 , 12571880 , 12571886 , 12572317 , 12572369 , 12572586 , 12572909 , 12573547 , 12573567 , 12573837 , 12573990 , 12574424 , 12574501 , 12574524 , 12574556 , 12574599 , 12574619 , 12574731 , 12574749 , 12574853 , 12574858 , 12574860 , 12574865 , 12574961 , 12575626 , 12575698 , 12575886 , 12576125 , 12576443 , 12576485 , 12576518 , 12576593 , 12576609 , 12576710 , 12576722 , 12577271 , 12577685 , 12578856 , 12579183",".","71 units","Plum A+ infusers have the potential for the distal (occlusion) press sensor pin to break. The distal pressure sensor pin is a part of the overall subsystem that measures the pressure within the distal line of the administration set and indicates the presence of a full or partial distal occlusion. A broken distal pin can only be detected via a visual inspection of the distal pressure pin. A broken distal pressure pin could result in incorrect distal pressure readings, undetected distal occlusions and/or undetected cassette failures.",2/1/2013,"02/01/2013",11/20/2013,"11/20/2013"
"Devices",64263,"Ongoing","Hospira Inc.","Lake Forest","IL","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution - USA (nationwide) including states of: AK, AL, AR, AZ, CA, CO, CT, DE, FL, GA, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV, WY, District of Columbia, Puerto Rico and U.S. Virgin Islands; and countries of: Costa Rica and Dominican Republic.","Z-0290-2014","Class II","The Plum A+ Infusion System is a cassette based multifunction infusion system that allows two lines in and one line out and can be used for standard, piggyback, or concurrent delivery. The Plum A+ Infusion System is designed to deliver parenteral, enteral, or epidural infusions over a broad range of infusion rates from multiple fluid container types. The Plum A+ Infusion System includes an infuser, disposable IV sets (hereafter called a set), optional accessories, and this operator's manual. The Plum A+ Infusion System with Hospira MedNet Software is indicated for use in parenteral, enteral and epidural therapies and the administration of whole blood and blood products.","Excessive data in the Code Information for this product has caused issues with the CSV download function. The complete list of Code Information can be found at the Addendum to Enforcement Report.",".","1) List Number 20679: 7,737 units; 2) List Number 20792: ","Plum A+ infusers have the potential for the distal (occlusion) press sensor pin to break. The distal pressure sensor pin is a part of the overall subsystem that measures the pressure within the distal line of the administration set and indicates the presence of a full or partial distal occlusion. A broken distal pin can only be detected via a visual inspection of the distal pressure pin. A broken distal pressure pin could result in incorrect distal pressure readings, undetected distal occlusions and/or undetected cassette failures.",2/1/2013,"02/01/2013",11/20/2013,"11/20/2013"
"Devices",64263,"Ongoing","Hospira Inc.","Lake Forest","IL","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution - USA (nationwide) including states of: AK, AL, AR, AZ, CA, CO, CT, DE, FL, GA, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV, WY, District of Columbia, Puerto Rico and U.S. Virgin Islands; and countries of: Costa Rica and Dominican Republic.","Z-0289-2014","Class II","The Plum A+3 Infusion System is a cassette based multifunction infusion system that allows two lines in and one line out and can be used for standard, piggyback, or concurrent delivery. The Plum A+3 Infusion System is designed to deliver parenteral, enteral, or epidural infusions over a broad range of infusion rates from multiple fluid container types. The Plum A+3 Infusion System includes an infuser, disposable IV sets (hereafter called a set), optional accessories, and this operator's manual. The Plum A+ Infusion System with Hospira MedNet Software is indicated for use in parenteral, enteral and epidural therapies and the administration of whole blood and blood products.","Excessive data in the Code Information for this product has caused issues with the CSV download function. The complete list of Code Information can be found at the Addendum to Enforcement Report.",".","21,551 units","Plum A+ infusers have the potential for the distal (occlusion) press sensor pin to break. The distal pressure sensor pin is a part of the overall subsystem that measures the pressure within the distal line of the administration set and indicates the presence of a full or partial distal occlusion. A broken distal pin can only be detected via a visual inspection of the distal pressure pin. A broken distal pressure pin could result in incorrect distal pressure readings, undetected distal occlusions and/or undetected cassette failures.",2/1/2013,"02/01/2013",11/20/2013,"11/20/2013"
"Devices",64263,"Ongoing","Hospira Inc.","Lake Forest","IL","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution - USA (nationwide) including states of: AK, AL, AR, AZ, CA, CO, CT, DE, FL, GA, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV, WY, District of Columbia, Puerto Rico and U.S. Virgin Islands; and countries of: Costa Rica and Dominican Republic.","Z-0286-2014","Class II","The Plum A+3 Infusion System is a cassette based multifunction infusion system that allows two lines in and one line out and can be used for standard, piggyback, or concurrent delivery. The Plum A+3 Infusion System is designed to deliver parenteral, enteral, or epidural infusions over a broad range of infusion rates from multiple fluid container types. The Plum A+3 Infusion System includes an infuser, disposable IV sets (hereafter called a set), optional accessories, and this operator's manual. The Plum A+ Infusion System with Hospira MedNet Software is indicated for use in parenteral, enteral and epidural therapies and the administration of whole blood and blood products.","1) List Number 12348; Serial Numbers: 13740156 , 13740256 , 13740266 , 13740351 , 13740380 , 13740451 , 13740508 , 13740612 , 13740632 , 13740731 , 13740732 , 13740733 , 13740734 , 13740735 , 13740736 , 13740737 , 13740738 , 13740739 , 13740740 , 13740741 , 13740742 , 13740743 , 13740744 , 13740745 , 13740746 , 13740747 , 13740748 , 13740749 , 13740750 , 13740751 , 13740752 , 13740753 , 13740754 , 13740755 , 13740756 , 13740757 , 13740758 , 13740759 , 13740760 , 13740761 , 13740762 , 13740763 , 13740764 , 13740765 , 13740766 , 13740767 , 13740768 , 13740769 , 13740770 , 13740771 , 13740772 , 13740773 , 13740774 , 13740775 , 13740776 , 13740777 , 13740778 , 13740779 , 13740780 , 13740781 , 13740782 , 13740783 , 13740784 , 13740785 , 13740786 , 13740787 , 13740788 , 13740789 , 13740790 , 13740791 , 13740792 , 13740793 , 13740794 , 13740795 , 13740796 , 13740797 , 13740798 , 13740799 , 13740800 , 13740801 , 13740802 , 13740803 , 13740804 , 13740805 , 13740806 , 13740807 , 13740808 , 13740809 , 13740810 , 13740811 , 13740812 , 13740813 , 13740814 , 13740815 , 13740816 , 13740818 , 13740819 , 13740820 , 13740821 , 13740822 , 13740823 , 13740824 , 13740825 , 13740826 , 13740827 , 13740828 , 13740829 , 13740830 , 13740831 , 13740832 , 13740833 , 13740834 , 13740835 , 13740836 , 13740837 , 13740838 , 13740839 , 13740840 , 13740841 , 13740842 , 13740843 , 13740844 , 13740845 , 13740846 , 13740847 , 13740848 , 13740849 , 13740850 , 13740851 , 13740852 , 13740853 , 13740854 , 13740855 , 13740856 , 13740857 , 13740858 , 13740859 , 13740860 , 13740861 , 13740862 , 13740863 , 13740864 , 13740865 , 13740866 , 13740867 , 13740868 , 13740869 , 13740870 , 13740871 , 13740872 , 13740873 , 13740874 , 13740875 , 13740876 , 13740877 , 13740878 , 13740879 , 13740880 , 13740881 , 13740882 , 13740883 , 13740884 , 13740885 , 13740886 , 13740887 , 13740888 , 13740889 , 137",".","214 units","Plum A+ infusers have the potential for the distal (occlusion) press sensor pin to break. The distal pressure sensor pin is a part of the overall subsystem that measures the pressure within the distal line of the administration set and indicates the presence of a full or partial distal occlusion. A broken distal pin can only be detected via a visual inspection of the distal pressure pin. A broken distal pressure pin could result in incorrect distal pressure readings, undetected distal occlusions and/or undetected cassette failures.",2/1/2013,"02/01/2013",11/20/2013,"11/20/2013"
"Devices",64263,"Ongoing","Hospira Inc.","Lake Forest","IL","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution - USA (nationwide) including states of: AK, AL, AR, AZ, CA, CO, CT, DE, FL, GA, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV, WY, District of Columbia, Puerto Rico and U.S. Virgin Islands; and countries of: Costa Rica and Dominican Republic.","Z-0288-2014","Class II","The Plum A+3 Infusion System is a cassette based multifunction infusion system that allows two lines in and one line out and can be used for standard, piggyback, or concurrent delivery. The Plum A+3 Infusion System is designed to deliver parenteral, enteral, or epidural infusions over a broad range of infusion rates from multiple fluid container types. The Plum A+3 Infusion System includes an infuser, disposable IV sets (hereafter called a set), optional accessories, and this operator's manual. The Plum A+ Infusion System with Hospira MedNet Software is indicated for use in parenteral, enteral and epidural therapies and the administration of whole blood and blood products.","Excessive data in the Code Information for this product has caused issues with the CSV download function. The complete list of Code Information can be found at the Addendum to Enforcement Report.",".","7,692 units","Plum A+ infusers have the potential for the distal (occlusion) press sensor pin to break. The distal pressure sensor pin is a part of the overall subsystem that measures the pressure within the distal line of the administration set and indicates the presence of a full or partial distal occlusion. A broken distal pin can only be detected via a visual inspection of the distal pressure pin. A broken distal pressure pin could result in incorrect distal pressure readings, undetected distal occlusions and/or undetected cassette failures.",2/1/2013,"02/01/2013",11/20/2013,"11/20/2013"
"Devices",64263,"Ongoing","Hospira Inc.","Lake Forest","IL","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution - USA (nationwide) including states of: AK, AL, AR, AZ, CA, CO, CT, DE, FL, GA, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV, WY, District of Columbia, Puerto Rico and U.S. Virgin Islands; and countries of: Costa Rica and Dominican Republic.","Z-0283-2014","Class II","The Plum A+ Hyperbaric Infusion System is a cassette based multifunction infusion system that allows two lines in and one line out and can be used for standard, piggyback, or concurrent delivery. The Plum A+ Hyperbaric Infusion System is designed to deliver parenteral, enteral, or epidural infusions over a broad range of infusion rates from multiple fluid container types. The Plum A+ Hyperbaric Infusion System includes an infuser, disposable IV sets (hereafter called a set), optional accessories, and this operator's manual. The Plum A+ Infusion System with Hospira MedNet Software is indicated for use in parenteral, enteral and epidural therapies and the administration of whole blood and blood products.","1) List Number 11005; Serial Numbers: 16792201 , 16792202 , 16792205 , 16792206 , 16792208 , 16792209 , 16792210 , 16792211 , 16792213 , 16792216 , 16792217 , 16792219 , 16792220 , 16792222 , 16792223 , 16792224 , 16792225 , 16792226 , 16792227 , 16792228 , 16792230 , 16792232 , 16792233 , 16792234 , 16792235 , 16792236 , 16792238 , 16792239 , 16792240 , 16792241 , 16792242 , 16792244 , 16792245 , 16792246 , 16792248 , 16792249 , 16792250 , 16792251 , 16792252 , 16792253 , 16792254 , 16792255 , 16792256 , 16792257 , 16792258 , 16792259 , 16792260 , 16792261 , 16792263 , 16792264 , 16792265 , 16792266 , 16792268 , 16792269 , 16792271 , 16792272 , 16792273 , 18807402 , 18807405 , 18807406 , 18807407 , 18807408 , 18807409 , 18807410 , 18807413 , 18807414 , 18807417 , 18807418 , 18807420 , 18807421 , 18807423 , 18807427 , 18807428 , 18807429 , 18807430 , 18807431 , 18807432 , 18807433 , 18807434 , 18807439 , 18807443 , 18807444 , 18807446 , 18807449 , 18807452 , 18807453 , 18807455 , 18807456 , 18807459 , 18807463 , 18807466 , 18807472 , 18807474 , 18807478 , 18807484 , 18807485 , 18807486 , 18807490 , 18807491 , 18807494 , 18807496 , 18807499 , 18807500 , 18807501 , 18807506 , 18807509 , 18807510 , 18807511 , 18807513 , 18807514 , 18807518 , 18807523 , 18807524 , 18807529 , 18807535 , 18807536 , 18807539 , 18807540 , 18807541 , 18807542 , 18807543 , 18807545 , 18807546 , 18807556 , 18807557 , 18807568 , 18807574 , 18807575 , 18807576 , 18807578 , 18807581 , 18807584 , 18807585 , 18807586 , 18807588 , 18807589 , 18807590 , 18807591 , 18807596 , 18807597 , 18807598 , 18807599 , 18807600 , 18807601 , 18807602 , 18807604 , 18807605 , 18807607 , 18807608 , 18807609 , 18807610 , 18807611 , 18807612 , 18807613 , 18807614 , 18807617 , 18807618 , 18807619 , 18807620 , 18807623 , 18807625 , 18807626 , 18807627 , 18807628 , 18807630 , 18807631 , 18807632 , 188",".","179 units","Plum A+ infusers have the potential for the distal (occlusion) press sensor pin to break. The distal pressure sensor pin is a part of the overall subsystem that measures the pressure within the distal line of the administration set and indicates the presence of a full or partial distal occlusion. A broken distal pin can only be detected via a visual inspection of the distal pressure pin. A broken distal pressure pin could result in incorrect distal pressure readings, undetected distal occlusions and/or undetected cassette failures.",2/1/2013,"02/01/2013",11/20/2013,"11/20/2013"
"Devices",64265,"Ongoing","Orthofix, Inc","Lewisville","TX","US","Voluntary: Firm Initiated","Letter","Worldwidewide Distribution - USA Nationwide including Puerto Rico and the countries of: Australia, Lebanon, Germany, Spain, Sweden and Israel.","Z-0896-2013","Class II","Firebird Spinal Fixation System, Parallel Rod Connector (52-6800) and Axial Rod Connector (52-6700). Product Usage: The connector assemblies allow for rod components to be connected side-to-side, or end-to-end and eliminate the need of rebuilding the entire system with a longer rod in order to include the new vertebral levels.","Catalog Numbers: 52-6800 & 52-6700; All Lot Numbers",,"565 total (287 PN 52-6800 and 278 PN 52- 6700)","There is a possibility that the Set Screw (p/n 90-2923) sub-component of the Parallel Rod Connector Assembly (p/n 52-6800) & Axial Rod Connector (p/n 52-6700) may crack during final tightening. Orthofix Inc received six (6) customer complaints related to set screw cracking between November 15, 2010 and December 2012. ",2/1/2013,"02/01/2013",3/6/2013,"03/06/2013"
"Drugs",64266,"Ongoing","Fresenius Kabi USA LLC (FK USA)","Schaumburg","IL","US","Voluntary: Firm Initiated","Letter","Nationwide","D-200-2013","Class III","CALCIUM GLUCONATE INJECTION, USP, 10% (100 mg/mL), 10 mL, Single Dose Vial, Rx only, For Direct Slow IV or IV Additive Use Only, APP Pharmaceuticals, LLC Schaumburg, IL 60173 --- Product Code 31110, NDC 63323-311-10","Lot 6004889, Expiration Date 10/2014",,"155,900 vials domestically","Labeling: Missing label",2/1/2013,"02/01/2013",3/20/2013,"03/20/2013"
"Drugs",64267,"Ongoing","Gilead Sciences, Inc.","Foster City","CA","US","Voluntary: Firm Initiated","E-Mail","Nationwide in USA, Canada, and UK (Gilead facility in Cork Ireland). Cork facility distributed to Germany/Austria, Italy and Spain.","D-324-2013","Class I","Vistide (cidofovir) Injection, 375 mg (75 mg/mL), 5 mL single-use vial, Rx only, Manufactured for: Gilead Sciences, Inc., Foster City, CA 94404, UPC 3 61958 01011 5; NDC 61958-0101-1.","Lot #: B120217A, Exp 05/15 - US Distribution ",,"3,181 vials ","Presence of Particulate Matter: Particulate matter was found in some vials of Vistide (cidofovir injection).",1/31/2013,"01/31/2013",5/22/2013,"05/22/2013"
"Biologics",64268,"Terminated","Indiana Lions Eye and Tissue Transplant Bank","Indianapolis","IN","US","Voluntary: Firm Initiated","E-Mail","Saudi Arabia; Indiana","B-0967-13","Class II","Cornea","CN100033OS; CN100033OD",,"2","Human Corneas, recovered from a donor whose donor screening was performed in a manner that did not determine the donor was free from risk factors for, and clinical evidence of infection due to relevant communicable disease agents and diseases, were distributed. ",12/27/2012,"12/27/2012",3/6/2013,"03/06/2013"
"Food",64269,"Ongoing","Star Snacks Co., Llc.","Jersey City","NJ","US","Voluntary: Firm Initiated","E-Mail","Pennsylvania, Ohio, North Carolina, Georgia and Illinois, New Jersey and New York.","F-0983-2013","Class II","Imperial Nuts and Snacks Chocolate and Peanut Platter. Packed By: Star Snacks CO., LLC, Jersey City, NJ 07305. Net Wt. 26 oz (737 g) UPC 5351946762.","Lots 20I272 and 19I276.",,"2260 cases (6 units per case).","Imperial Nuts & Snacks brand of Chocolate and Peanut Platter (Net Weight 26 ounces) has undeclared FD&C colors Blue #1, Red #40, Yellow #5 and Yellow #6.",1/2/2013,"01/02/2013",2/13/2013,"02/13/2013"
"Food",64270,"Terminated","Hoop Nuts LLC DBA Christophers Nut Co","Van Nuys","CA","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","CA","F-0996-2013","Class I","ARO PISTACHIO/ ORANDI FARMS PISTACHIO HALVES N PIECES 30LB WHITE CORRUGATED BOXES-Pistachios Raw","Lot #121203",,"20 cases (600 lbs) total","Hoop Nuts is recalling Pistachios due to Salmonella.",12/24/2012,"12/24/2012",2/20/2013,"02/20/2013"
"Food",64270,"Terminated","Hoop Nuts LLC DBA Christophers Nut Co","Van Nuys","CA","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","CA","F-0997-2013","Class I","ARO PISTACHIO/ ORANDI FARMS PISTACHIO HALVES N PIECES 30LB WHITE CORRUGATED BOXES-Pistachios Dry Roasted","Lot #1-121213",,"20 cases (600 lbs) total","Hoop Nuts is recalling Pistachios due to Salmonella.",12/24/2012,"12/24/2012",2/20/2013,"02/20/2013"
"Devices",64271,"Ongoing","Synthes USA HQ, Inc.","West Chester","PA","US","Voluntary: Firm Initiated","Letter","Nationwide Distribution including AL, AR, AZ, CA, CO, CT, DE, FL, GA, IL, KS, KY, LA, MD, ME, MI, MN, MO, NC, NE, NH, NJ, NV, NY, OH, OR, PA, RI, TN, TX, VA, VT, WI, WV, and WY.","Z-1016-2013","Class II","Synthes Dens Instrument Set (Dens Graphic Case), Part Number 687.030 (also known as the Anterior Column Retractor Set) The Synthes Dens instrument Set has been designed to facilitate internal fixation of the odontoid process for the reduction of Type II and shallow Type III fractures, as proposed by Anderson and d'Alonzo. ","Part number 687.030, All Lots",,"148","The Dens Instrument Set has been designed to facilitate the anterior internal fixation of the Dens (odontoid process). There are currently no screws specifically indicated to treat Dens fractures via anterior screw fixation therefore the affected product will be removed. ",1/11/2013,"01/11/2013",4/3/2013,"04/03/2013"
"Devices",64272,"Ongoing","Ultradent Products, Inc.","South Jordan","UT","US","Voluntary: Firm Initiated","Letter","Nationwide Distribution","Z-0811-2013","Class III","Ultradent Products, Chromaclone PVS, Regular Set heavy body, Bubble Gum Flavor, 50 ml, Impression Material, Part No. 5012, Lot No. B7PPC. Used in prosthodontics.","Part No. 5012, Lot No. B7PPC",,"32 cartridges","Incorrect packaging of regular set and fast set cartridges.",2/4/2013,"02/04/2013",2/20/2013,"02/20/2013"
"Devices",64272,"Ongoing","Ultradent Products, Inc.","South Jordan","UT","US","Voluntary: Firm Initiated","Letter","Nationwide Distribution","Z-0812-2013","Class III","Ultradent Product, Chromaclone PVS, Fast Set heavy body, Bubble Gum Flavor, 50 ml, Impression Material, Part No. 5013, Lot No. B7DS3, Used in prosthodontics.","Lot No. B7DS3",,"100 cartridges","Incorrect packaging of regular set and fast set cartridges.",2/4/2013,"02/04/2013",2/20/2013,"02/20/2013"
"Devices",64274,"Completed","GE Healthcare, LLC","Waukesha","WI","US","Voluntary: Firm Initiated","Visit","Worldwide Distribution-USA including the states of FL, IL, IN, NJ, NC, OK, TX, and WI, and the countries of UNITED KINGDOM, TUNISIA, SERBIA, RUSSIAN FEDERATION, NORWAY, NIGERIA, LITHUANIA, LEBANON, KOREA, REPUBLIC OF KOREA, ITALY, INDONESIA, INDIA, FRANCE, FINLAND, COLOMBIA, CHINA, and BRAZIL.","Z-0934-2013","Class II","GE Healthcare, Innova 2100 IQ, Innova 3100 IQ, Innova 4100 IQ. Cardiovascular X-ray imagingsystems. For use in generating fluoroscopic images of human anatomy. ","SERIAL NUMBER592043BU4 592676BU1 593459BU1 593465BU8 592458BU4 592673BU8 592682BU9 593059BU9 593051BU6 593475BU7 593476BU5 592049BU1 593468BU2 593054BU0 592047BU5 592042BU6 592046BU7 592459BU2 593048BU2 593056BU5 593049BU0 593063BU1 593062BU3 593464BU1 594762BU7 593473BU2 592451BU9 593460BU9 597954BU7 592456BU8 592674BU6 593052BU4 593058BU1 590867BU8 592050BU9 593064BU9 592460BU0 592457BU6 592680BU3 592455BU0 593462BU5 592678BU7 594763BU5 593055BU7 592675BU3 592452BU7 593463BU3 594385BU7 ",,"48","Exposed high voltage wires inside the cabinet . On a cable located in the system cabinet, two of the shrink tubings covering the 400V live cable leave an area potentially unprotected. ",2/4/2011,"02/04/2011",3/20/2013,"03/20/2013"
"Food",64275,"Terminated","Domega NY International Co Ltd","Brooklyn","NY","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","NY Metro area","F-1279-2013","Class I","GREEN DAY DRIED COCONUT, Net Wt: 3oz (85g), UPC bar code 6 950296 800744 -- Manufacturer: Jiangmen Xinhui Parksun Food Co., Ltd. -- Add: Donggua Hill, Beitou Village, Qibao, Xinhui District, Jiangmen City, Guangdong, Produce of P.R.C. -- Packed For: Domega NY International Co., Ltd., 1916 West 13th Street Brooklyn, N.Y. 11223 Tel: (646) 388-3032, Fax: (718) 499-2603 -- Nutrition Facts: Serving Size 100g -- Servings Per Container 0.9 --- The product is packed in a sealed, flexible plastic bag. ","Code: Exp 12/15/2014 --- 2/13/13 Expansion: MFD 09/14/2012 EXP 09/13/2014",".","71 cases total ( 50 x 85 gm packages per case)","The products contained undeclared sulfites (251 ppm and 398 ppm respectively) based on sampling and analysis by New York State Department of Agriculture & Markets.",2/4/2013,"02/04/2013",4/10/2013,"04/10/2013"
"Devices",64276,"Terminated","Bard Peripheral Vascular Inc","Tempe","AZ","US","Voluntary: Firm Initiated","Letter","Nationwide Distribution including AL, AR, AZ, CA, CO, CT, DC, FL, GA, HI, IA, IL, IN, KY, KS, LA, MA, MD, MI, MN, MO, MS, NC, NJ, NY, OH, OK, PA, TX, VA, WA, WV and WY.","Z-1528-2013","Class II","MICROSHEATH - 0.066 (1.7mm) proximal, 0.064 (1.6mm); WL 123cm, RGC 8F Guide; minimum ID: 0.086''/ (2.2mm);distal, straight non-tapered tip; PK1018-03A; Bard Peripheral Vascular; Manuf: Flow Cardia, Inc., a Subsidiary of C.R. Bard, Inc. 745 North Pastoria Ave., Sunnyvale, CA 94085. The MicroSheath and Usher Support Catheters are single lumen catheters intended to create a pathway for other devices in the peripheral vasculature. MicroSheath is a single lumen catheter that has a 123cm working length and a straight tip shape","PC MS17123; Lot# FCWC10010",".","17","Bard Peripheral Vascular (BPV) is initiating this recall because a combination of Bard UltraClip Dual Trigger Tissue Marker's and support catheters (Microsheath and Usher) were inadvertently distributed to customers without completing the sterilization process (non sterile).",1/23/2013,"01/23/2013",6/19/2013,"06/19/2013"
"Devices",64276,"Terminated","Bard Peripheral Vascular Inc","Tempe","AZ","US","Voluntary: Firm Initiated","Letter","Nationwide Distribution including AL, AR, AZ, CA, CO, CT, DC, FL, GA, HI, IA, IL, IN, KY, KS, LA, MA, MD, MI, MN, MO, MS, NC, NJ, NY, OH, OK, PA, TX, VA, WA, WV and WY.","Z-1529-2013","Class II","USHER Support Catheter- Angled Tip WL130cm, RI 7F; REF USH07AT; PK1022-01A; Rx only, Non-Pyrogenic, Sterile; Bard Peripheral Vascular; Manuf: FlowCardia, Inc., a Subsidiary of C. R. Bard, Inc., 745 North Pastoria Ave, Sunnyvale CA 95085. The Usher Peripheral is a single lumen support catheter, with a standard luer fitting at the proximal end. The Usher Peripheral is available in a length 130 cm with an angled tip shape. ","PC USH07AT; Lot# FCWC10009",".","223","Bard Peripheral Vascular (BPV) is initiating this recall because a combination of Bard UltraClip Dual Trigger Tissue Marker's and support catheters (Microsheath and Usher) were inadvertently distributed to customers without completing the sterilization process (non sterile).",1/23/2013,"01/23/2013",6/19/2013,"06/19/2013"
"Devices",64276,"Terminated","Bard Peripheral Vascular Inc","Tempe","AZ","US","Voluntary: Firm Initiated","Letter","Nationwide Distribution including AL, AR, AZ, CA, CO, CT, DC, FL, GA, HI, IA, IL, IN, KY, KS, LA, MA, MD, MI, MN, MO, MS, NC, NJ, NY, OH, OK, PA, TX, VA, WA, WV and WY.","Z-1526-2013","Class II","BARD Biopsy Systems (A Business Unit of Bard Peripheral Vascular, Inc.), UltraClip Dual Trigger Breast Tissue Marker 17g X 10cm needle, Ultrasound Enhanced Coil Marker 5 Pack; Sterilize, Non-pyrogenic, Rx only, Single Use; Bard Peripheral Vascular, Inc., 1625 West 3rd Street, Tempe, AZ 85281 USA. PK4320100 Rev. 0 03/10 The UltraClip Dual Trigger breast tissue marker is a sterile, single use device comprised of a disposable introducer, and a metal implantable tissue marker with polyvinyl alcohol (PVA). ","PC 864017D; Lots: HUWK1296, HUWK1297",".","815","Bard Peripheral Vascular (BPV) is initiating this recall because a combination of Bard UltraClip Dual Trigger Tissue Marker's and support catheters (Microsheath and Usher) were inadvertently distributed to customers without completing the sterilization process (non sterile).",1/23/2013,"01/23/2013",6/19/2013,"06/19/2013"
"Devices",64276,"Terminated","Bard Peripheral Vascular Inc","Tempe","AZ","US","Voluntary: Firm Initiated","Letter","Nationwide Distribution including AL, AR, AZ, CA, CO, CT, DC, FL, GA, HI, IA, IL, IN, KY, KS, LA, MA, MD, MI, MN, MO, MS, NC, NJ, NY, OH, OK, PA, TX, VA, WA, WV and WY.","Z-1527-2013","Class II","BARD Biopsy Systems (A Business Unit of Bard Peripheral Vascular, Inc.), UltraClip Dual Trigger Breast Tissue Marker 17g X 10cm needle, Ultrasound Enhanced Ribbon Marker 5 Pack, Sterile, Single Use, Non-pyrogenic, Rx only; Bard Peripheral Vascular, Inc., 1625 West 3rd Street, Tempe, AZ 85281 USA. PK4313800 Rev. 1 01/11 The UltraClip Dual Trigger breast tissue marker is a sterile, single use device comprised of a disposable introducer, and a metal implantable tissue marker with polyvinyl alcohol (PVA). ","PC 863017D; Lot: HUWL0010",".","315","Bard Peripheral Vascular (BPV) is initiating this recall because a combination of Bard UltraClip Dual Trigger Tissue Marker's and support catheters (Microsheath and Usher) were inadvertently distributed to customers without completing the sterilization process (non sterile).",1/23/2013,"01/23/2013",6/19/2013,"06/19/2013"
"Biologics",64277,"Terminated","LifeServe Blood Center","Des Moines","IA","US","Voluntary: Firm Initiated","Telephone","IA","B-1210-13","Class III","Platelets Pooled Leukocytes Reduced","W037912556178",".","1 unit","Blood product, collected from a donor with no documentation on the donor record of an arm inspection or general appearance, was distributed.",1/21/2013,"01/21/2013",5/29/2013,"05/29/2013"
"Biologics",64278,"Terminated","LifeServe Blood Center","Des Moines","IA","US","Voluntary: Firm Initiated","Telephone","IA","B-1211-13","Class III","Platelets Pooled Leukocytes Reduced Irradiated","W037912556179",".","1 unit","Blood product, collected from a donor with no documentation on the donor record of an arm inspection or general appearance, was distributed.",1/21/2013,"01/21/2013",5/29/2013,"05/29/2013"
"Biologics",64279,"Terminated","Inland Northwest Blood Center","Spokane","WA","US","Voluntary: Firm Initiated","FAX","WA","B-1213-13","Class III","Red Blood Cells (Apheresis) Leukocytes Reduced","W068511031449",".","1 unit","Blood products, manufactured from Whole Blood units that were stored at an incorrect temperature, were distributed. ",1/7/2013,"01/07/2013",5/29/2013,"05/29/2013"
"Biologics",64279,"Terminated","Inland Northwest Blood Center","Spokane","WA","US","Voluntary: Firm Initiated","FAX","WA","B-1214-13","Class III","Red Blood Cells Leukocytes Reduced","W068512601781; W068512022191; W068512103816; W068512210571; W068512022307; W068512103830; W068512322177; W068512382313; W068512501917; W068512501915; W068511106868; W068512200074; W068511106838; W068511323195; ",".","14 units","Blood products, manufactured from Whole Blood units that were stored at an incorrect temperature, were distributed. ",1/7/2013,"01/07/2013",5/29/2013,"05/29/2013"
"Biologics",64279,"Terminated","Inland Northwest Blood Center","Spokane","WA","US","Voluntary: Firm Initiated","FAX","WA","B-1212-13","Class III","Red Blood Cells Leukocytes Reduced Irradiated","W068512202667; W068512382308",".","2 units","Blood products, manufactured from Whole Blood units that were stored at an incorrect temperature, were distributed. ",1/7/2013,"01/07/2013",5/29/2013,"05/29/2013"
"Biologics",64280,"Terminated","Mississippi Valley Reg Bld Ctr","Davenport","IA","US","Voluntary: Firm Initiated","Telephone","IA","B-1215-13","Class II","Plasma Frozen within 24 hours (FP24)","W333612096391",".","1 unit","Blood product, expired unit returned to the firm was inappropriately re-labeled, was distributed.",12/18/2012,"12/18/2012",5/29/2013,"05/29/2013"
"Food",64281,"Ongoing","Phil-Am Trading, Inc.","Jersey City","NJ","US","Voluntary: Firm Initiated","Telephone","74 customers mainly located in NJ, NY and Pennsylvania.","F-1133-2013","Class III","Tausi Brand Salted Black Beans. Net Weight 180g (6.34 oz). Distributed by: V8 Commercial Co., Inc. San Juan, Metro Manila. Product of the Philippines.","UPC 897399001097; Best by: BB Sep 21 2010.",,"247 Cartons (100 cans per carton).","This recall has been initiated due to suspected but, as of the writing of this letter (1/17/2013), unconfirmed Clostridium botulinum (C. botulinum) contamination. ",1/18/2013,"01/18/2013",3/20/2013,"03/20/2013"
"Food",64282,"Terminated","Mkg Provisions Inc","Miami","FL","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","FL and IL","F-1050-2013","Class I","Cold Smoke Atlantic Salmon Trimmings Vacuum Packed ","Batch #1478-69441 and #911",,"3,425 lbs total","Results from the company lab samples revealed that some of the samples contained Listeria monocytogenes.",12/18/2012,"12/18/2012",3/13/2013,"03/13/2013"
"Food",64282,"Terminated","Mkg Provisions Inc","Miami","FL","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","FL and IL","F-1047-2013","Class I","UpRiver brand Cold Smoke Atlantic Salmon Pre-sliced Vacuum Packed, 4 oz.. ","Batch #911",,"1,020 lbs Total","Results from the company lab samples revealed that some of the samples contained Listeria monocytogenes.",12/18/2012,"12/18/2012",3/13/2013,"03/13/2013"
"Food",64282,"Terminated","Mkg Provisions Inc","Miami","FL","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","FL and IL","F-1049-2013","Class I","Cold Smoke Atlantic Salmon Nordic Choice Pre-sliced Vacuum Packed ","Batch #1478-69441",,"3,425 lbs total","Results from the company lab samples revealed that some of the samples contained Listeria monocytogenes.",12/18/2012,"12/18/2012",3/13/2013,"03/13/2013"
"Food",64282,"Terminated","Mkg Provisions Inc","Miami","FL","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","FL and IL","F-1048-2013","Class I","UpRiver brand Cold Smoke Atlantic Salmon Balik Cut Sides Vacuum Packed ","Batch #911",,"1,020 lbs total","Results from the company lab samples revealed that some of the samples contained Listeria monocytogenes.",12/18/2012,"12/18/2012",3/13/2013,"03/13/2013"
"Food",64283,"Ongoing","Tristar Food Wholesale Co Inc","Jersey City","NJ","US","Voluntary: Firm Initiated","Telephone","NY, Philadelphia, PA and metro Boston, MA areas.","F-0982-2013","Class II","Outer Cardboard Container - China Products Fresh Dried Cabbage. Plastic Bag: Double Swallow Brand, Net Wt 0.15 Kg (529 OZ), Dehydrated Cole, Jiangmen Native Produce Import & Export Company of Guangdong China.","All codes.",,"27 cases (100 - 150g bags per case)","The product contains undeclared sulfites (as a preservative). ",12/18/2012,"12/18/2012",2/13/2013,"02/13/2013"
"Food",64284,"Ongoing","Deep Foods Inc","Union","NJ","US","Voluntary: Firm Initiated","Telephone","27 states (Alabama, Arizona, California, Colorado, Connecticut, Delaware, Florida, Georgia, Idaho, Illinois, Louisiana, Massachusetts, Maryland, Maine, Mississippi, Missouri, North Carolina, New Hampshire, New Jersey, New York, Ohio, Pennsylvania, Rhode Island, South Carolina, Tennessee, Virginia and West Virginia.","F-1051-2013","Class II","Deep Best Quality Dry Garlic Chutney (Thechaa); Net Wt. 4 OZ.; UPC 011433111201; Deep Foods, Inc. Union, NJ 07083","UPC 011433111201",,"7000 units per month","Unapproved dye in product (Rhodamine B - Basic Violet 10).",12/27/2012,"12/27/2012",3/13/2013,"03/13/2013"
"Devices",64285,"Ongoing","DePuy Orthopaedics, Inc.","Warsaw","IN","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution - USA including the states of ME, MA, PA, MD, FL, LA, IL, IA, OH, MN, TX, MT, WA, CA, HI, NV, AZ, KY, WI, CO, GA, MI, TN, NY, AR, NC and VA and the countries of Canada, Chile, Germany, Czech Republic, Israel , Norway, Poland, Slovenia, Australia, New Zealand, South Africa, Belgium, Austria, Switzerland, France, England and County Cork, Ireland.","Z-0972-2013","Class II","ReClaim Reamer Extension; Product code 2975-00-500, used with Reclaim Modular Revision Hip Prosthesis System. The ReClaim Reamer Extension is as an attachment to the distal reamers to allow the surgeon to clear soft tissue while reaming the distal femoral canal.","Engraved Lot Number/ Label Lot NumberJ0111 / 578910 578913 R578910 R578912 R578913 In Kit # 2975-50-025 J0211/ In Kit # 2975-50-025 J0411/ 582631 In Kit # 2975-50-025 J0611/ In Kit # 2975-50-025 J0911/ 592125 In Kit # 2975-50-025 J1211/ 000003583 In Kit # 2975-50-025 NB12649 / NB12649 NB12650 / NB12650 NB12651 / NB12651 NB12652 / NB12652 NB12653/ NB12653 NB12654/ NB12654 NB12655/ NB12655 NB12656/ NB12656 NB23480/ NB23480 NB23481/ NB23481 NB3584 / In Kit # 2975-50-025 NB3586 / NB3586 NB3587 / NB3587 NB3588 / In Kit # 2975-50-025 NB3590 / NB3590 NB3591 / In Kit # 2975-50-025 NB5955 / NB5955 NB7894 / NB7894 In Kit # 2975-50-025 NB8016 / In Kit # 2975-50-025 NB8017 / NB8017 NB8018 / NB8018 In Kit # 2975-50-025 NB8019 / In Kit # 2975-50-025 NB8020 / NB8020 NB8021 / NB8021 NB8022 / NB8022 NB8023 /NB8023 ",".","750 ","DePuy has received 9 complaints where the tabs on the reamer extension device were broken. It was determined to notify surgeons of the issue to increase the awareness and to ask surgeons and users to look for tabs before and after surgery to reduce any potential that the tabs are left in the patient while DePuy investigates the root cause. Once the root cause is determined and a design change is implemented, DePuy will conduct a formal swap-out of the affected devices.",2/25/2013,"02/25/2013",3/27/2013,"03/27/2013"
"Drugs",64286,"Ongoing","Ranbaxy Inc.","Princeton","NJ","US","Voluntary: Firm Initiated","Letter","Nationwide and Puerto Rico","D-163-2013","Class III","Lac-Hydrin (ammonium lactate) Cream, 12%, packaged in a) 280 g (2 x 140 g tubes), NDC 10631-099-28; b) 385 g bottle, NDC 10631-099-38; Rx only, Ranbaxy, Jacksonville, FL 32257 USA. ","Lot #: RB91881, Exp 07/14; RB91891, Exp 07/13",,"6,535 tubes and bottles","Crystallization: Recall is due to a non-characteristic gritty/sandy texture to the product which is likely due to some crystallization of the product.",12/27/2012,"12/27/2012",2/20/2013,"02/20/2013"
"Drugs",64286,"Ongoing","Ranbaxy Inc.","Princeton","NJ","US","Voluntary: Firm Initiated","Letter","Nationwide and Puerto Rico","D-162-2013","Class III","Lac-Hydrin (ammonium lactate) Lotion, 12%, packaged in 400 g bottles, Rx only, Ranbaxy, Jacksonville, FL 32257 USA, NDC 10631-098-14.","Lot #: RB93911, Exp 07/14",,"4,016 bottles","Crystallization: Recall is due to a non-characteristic gritty/sandy texture to the product which is likely due to some crystallization of the product.",12/27/2012,"12/27/2012",2/20/2013,"02/20/2013"
"Devices",64287,"Ongoing","Synthes USA HQ, Inc.","West Chester","PA","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution -- USA, including the states of CA, LA, MA, NY, and PA, and the countries of Canada and Switzerland.","Z-0942-2013","Class II","Synthes Titanium Midface Distractor, MR Conditional, Part number 487.982. For temporary stabilization and gradual lengthening of the cranial or midfacial bones.","All Lots",,"596","There is the potential for the anterior footplates to not fit onto the Titanium Midface Distractor Assembly as the tab of some distractors may be oversized. ",1/11/2013,"01/11/2013",3/20/2013,"03/20/2013"
"Devices",64288,"Ongoing","Maquet Cardiovascular Us Sales, Llc","Wayne","NJ","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution-USA including the states of AZ, CO, FL, TN, and TX and the countries of Australia, Canada, Czech Republic, Dubai/Bahrain/Kuwait/Lebanon/Saudi Arabia/Yemen, France, Germany, Hong Kong, Italy, Japan, Netherlands, Singapore, South Africa, Sweden, Switzerland, Thailand, Turkey, and UK.","Z-0839-2013","Class II","Maquet ELS Cannula 15 FR. Used for extracorporeal membrane oxygenation (ECMO) for the treatment of respiratory insufficiency in infants.","US Distribution Part number 701017471 Lot numbers 92046825 92065723 92076940 OUS Distribution Part Number Lot Numbers 701002797 92050616 701002797 92052823 701002797 92052913 701002797 92058153 701002797 92063518 701002797 92068260 701002797 92069267 701002797 92072177 701002797 92075413 701002797 92077862 701005092 92081862 701005092 92049129 701005092 92070554 701005093 92049130 701005093 92056899 701005093 92065588 701005093 92069429 701005093 92070553 701005093 92071852 701005093 92073598 701005093 92076875 701017471 92076940 701046644 92063587 701050978 92047882 701050978 92053930 701050978 92054156 701050978 92056171 701050978 92056804 701050978 92065094 701050978 92067382 701050978 92068224 701050978 92069286 701050978 92071806",".","41 units - US Distirbution; 216 units - OUS Distribution","ELS 15 Fr Cannula could potentially contain an occluded arterial lumen.",12/26/2012,"12/26/2012",2/27/2013,"02/27/2013"
"Food",64289,"Ongoing","Tropical Nut & Fruit Co., Inc.","Orlando","FL","US","Voluntary: Firm Initiated","Press Release","Distribution Pattern: FL and NC","F-0990-2013","Class I","Labeled in part: ''All Natural Chia ReCharged Stix Mix***Chia Seed Sticks***Net Wt. 5oz'', UPC Code: 0 94184 01014 6","Lot #'s: 052112, 060512, 071712, 080212, and 081612; Best Before dates 01/20/13 to 04/17/13 ",,"1,380 lbs","Undeclared peanuts.",1/28/2013,"01/28/2013",2/20/2013,"02/20/2013"
"Food",64290,"Ongoing","Mkg Provisions Inc","Miami","FL","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Florida & Maryland","F-1258-2013","Class I","UpRiver Tri-Peppered Vodka Smoked Salmon (2-3 lbs)","Lot 1768",,"4.49 lbs.","Private lab result was positive for Listeria Monocytogenes",2/6/2013,"02/06/2013",4/3/2013,"04/03/2013"
"Food",64290,"Ongoing","Mkg Provisions Inc","Miami","FL","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Florida & Maryland","F-1256-2013","Class I","Cold Smoked Salmon Trimmings (5 lbs.) ","Lot 1768",,"80 lbs.","Private lab result was positive for Listeria Monocytogenes",2/6/2013,"02/06/2013",4/3/2013,"04/03/2013"
"Food",64290,"Ongoing","Mkg Provisions Inc","Miami","FL","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Florida & Maryland","F-1262-2013","Class I","Prestige Irish Style Smoked Salmon (4 oz..)","Lot 1768",,"9 lbs.","Private lab result was positive for Listeria Monocytogenes",2/6/2013,"02/06/2013",4/3/2013,"04/03/2013"
"Food",64290,"Ongoing","Mkg Provisions Inc","Miami","FL","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Florida & Maryland","F-1259-2013","Class I","UpRiver Tequila/Cilantro Smoked Salmon Sides( 2-3 lbs.)","Lot 1768",,"8.19 lbs.","Private lab result was positive for Listeria Monocytogenes",2/6/2013,"02/06/2013",4/3/2013,"04/03/2013"
"Food",64290,"Ongoing","Mkg Provisions Inc","Miami","FL","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Florida & Maryland","F-1255-2013","Class I","Pastrami Style Smoked Salmon Pre-sliced Sides(2.5-3.5 lbs. and 2-3 lbs.)","Lot 1768",,"Prestige: 33.81 lbs.; UpRiver: 17.37 lbs.","Private lab result was positive for Listeria Monocytogenes",2/6/2013,"02/06/2013",4/3/2013,"04/03/2013"
"Food",64290,"Ongoing","Mkg Provisions Inc","Miami","FL","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Florida & Maryland","F-1257-2013","Class I","Prestige Smoked Scottish 2.5-3.5 Smoked Salmon Sides (2-3 lbs.) ","Lot 1768",,"69 PCS","Private lab result was positive for Listeria Monocytogenes",2/6/2013,"02/06/2013",4/3/2013,"04/03/2013"
"Food",64290,"Ongoing","Mkg Provisions Inc","Miami","FL","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Florida & Maryland","F-1254-2013","Class I","Scottish Style Smoked Salmon Pre-sliced Sides (2-3 lbs)","Lot 1768",,"10 cases","Private lab result was positive for Listeria Monocytogenes",2/6/2013,"02/06/2013",4/3/2013,"04/03/2013"
"Food",64290,"Ongoing","Mkg Provisions Inc","Miami","FL","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Florida & Maryland","F-1263-2013","Class I","Prestige Nova Smoked Salmon retail packs (4 oz.) ","Lot 1768",,"6 lbs. ","Private lab result was positive for Listeria Monocytogenes",2/6/2013,"02/06/2013",4/3/2013,"04/03/2013"
"Food",64290,"Ongoing","Mkg Provisions Inc","Miami","FL","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Florida & Maryland","F-1261-2013","Class I","Norwegian Smoked Salmon (4 oz..) ","Lot 1768",,"UpRiver: 36 lbs.; Prestige: 18 lbs. ","Private lab result was positive for Listeria Monocytogenes",2/6/2013,"02/06/2013",4/3/2013,"04/03/2013"
"Food",64290,"Ongoing","Mkg Provisions Inc","Miami","FL","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Florida & Maryland","F-1260-2013","Class I","Prestige Scottish Smoked Salmon 16 oz.","Lot 1768",,"10 lbs.","Private lab result was positive for Listeria Monocytogenes",2/6/2013,"02/06/2013",4/3/2013,"04/03/2013"
"Food",64290,"Ongoing","Mkg Provisions Inc","Miami","FL","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Florida & Maryland","F-1264-2013","Class I","UpRiver Norwegian Smoked Salmon Peppered (2-3 lbs.)","Lot 1768",,"2.33 lbs","Private lab result was positive for Listeria Monocytogenes",2/6/2013,"02/06/2013",4/3/2013,"04/03/2013"
"Food",64290,"Ongoing","Mkg Provisions Inc","Miami","FL","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Florida & Maryland","F-1253-2013","Class I","Norwegian Smoked Salmon Sides (2-3 lbs.) ","Lot 1768 ",," UpRiver: 242.06 lbs.; Legendary 324 lbs.","Private lab result was positive for Listeria Monocytogenes",2/6/2013,"02/06/2013",4/3/2013,"04/03/2013"
"Devices",64291,"Ongoing","GE Healthcare, LLC","Waukesha","WI","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution - USA (All States in continental USA including PR except RI.). Internationall to:ALGERIA, ARGENTINA, AUSTRALIA, AUSTRIA, AZERBAIJAN, BRAZIL, BELARUS, BELGIUM, BULGARIA, BOSNIA & HERZEGOVINA, CANADA, CHILE, CHINA, COLOMBIA, CROATIA, CZECH REPUBLIC, DENMARK, EGYPT, ESTONIA, FINLAND, FRANCE, FRENCH POLYNESIA, GEORGIA, GERMANY, GREECE, GUADELOUPE, HONDURAS, HUNGARY, INDIA, INDONESIA, IRAN, ISLAMIC REPUBLIC OF IRAN, IRAQ, ITALY, IRELAND, ISRAEL, JAPAN, JORDAN, KENYA, KOREA, KUWAIT, KAZAKHSTAN, LATVIA, LEBANON, LIBYA, LITHUANIA, LUXEMBOURG, MALAYSIA, MEXICO, MACEDONIA, MARTINIQUE, MOROCCO, NETHERLANDS, NORWAY, PAKISTAN, PERU, PHILIPPINES, REUNION, NEW ZEALAND, OMAN, POLAND, PORTUGAL, ROMANIA, RUSSIAN FEDERATION, SAUDI ARABIA, SERBIA, SOUTH AFRICA, SPAIN, SUDAN, SWEDEN, SINGAPORE , SLOVAKIA, SOUTH KOREA, SWITZERLAND, SYRIA, TAIWAN, THAILAND, TURKEY, TUNISIA, UNITED ARAB EMIRATES, UNITED KINGDOM, UZBEKISTAN, VENEZUELA, URUGUAY, VIET NAAM, and YUGOSLAVIA.","Z-0935-2013","Class II","Optima MR450w, Discovery MR450, Discovery MR750, Signa HDx, Signa HDxt, Signa HDi, Signa Vibrant, and GE 1.5T Signa HDe MR System. The GE Signa HDx MR system is a whole body magnetic resonance scanner.","Serial Number 000000000R6708 00000241143MR7 00000027552MR4 00000028626MR7 00000028674MR1 00000262235MR5 00000272922MR6 00000273268MR3 00000273598MR3 00000273631MR2 00000273632MR0 00000274287MR2 00000274288MR0 00000274740MR0 00000274742MR6 00000274886MR1 00000274887MR9 00000275000MR8 00000275001MR6 00000275003MR2 00000275463MR8 00000275464MR6 00000275527MR0 00000275528MR8 00000275533MR8 00000275534MR6 00000275535MR3 00000275536MR1 00000275537MR9 00000275538MR7 00000275539MR5 00000276137MR7 00000276164MR1 00000276184MR9 00000276196MR3 00000276197MR1 00000276241MR7 00000276242MR5 00000276243MR3 00000276244MR1 00000276245MR8 00000276457MR9 00000276458MR7 00000276461MR1 00000276637MR6 00000276656MR6 00000276657MR4 00000276658MR2 00000276659MR0 00000276660MR8 00000276676MR4 00000276678MR0 00000276680MR6 00000277441MR2 00000277442MR0 00000277443MR8 00000277444MR6 00000277531MR0 00000277533MR6 00000277534MR4 00000277535MR1 00000277639MR1 00000277640MR9 00000277642MR5 00000277643MR3 00000277780MR3 00000277782MR9 00000277916MR3 00000277917MR1 00000277918MR9 00000277919MR7 00000278037MR7 00000278038MR5 00000278040MR1 00000278041MR9 00000278101MR1 00000278102MR9 00000278104MR5 00000278105MR2 00000278164MR9 00000278167MR2 00000278219MR1 00000278221MR7 00000278312MR4 00000278313MR2 00000278315MR7 00000278389MR2 00000278390MR0 00000278391MR8 00000278392MR6 00000278552MR5 00000278553MR3 00000278554MR1 00000278555MR8 00000278556MR6 00000278605MR1 00000278606MR9 00000278607MR7 00000278672MR1 00000278673MR9 00000278674MR7 00000278675MR4 00000278676MR2 00000278797MR6 00000278798MR4 00000278799MR2 00000278800MR8 00000278801MR6 00000279065MR7 00000279066MR5 00000279158MR0 00000279165MR5 00000279166MR3 00000279398MR2 00000279402MR2 00000279414MR7 00000279415MR4 00000279416MR2 00000279445MR1 00000279446MR9 00000279447MR7 00000279448MR5 00000279449MR3 00000279461MR8 00000279462MR6 00000279463MR4 00000279464MR2 00000279465MR9 00000279562MR3 00000279563MR1 00000279615MR9 00000279616MR7 00000279618MR3 00000279870MR0 00000279882MR5 000002"," 00000289657MR9 00000289658MR7 00000289659MR5 00000289660MR3 00000289761MR9 00000289762MR7 00000289763MR5 00000289764MR3 00000289765MR0 00000289774MR2 00000289775MR9 00000289776MR7 00000289777MR5 00000289781MR7 00000289782MR5 00000289784MR1 00000289789MR0 00000289790MR8 00000289791MR6 00000289793MR2 00000289818MR7 00000289820MR3 00000289821MR1 00000289822MR9 00000289845MR0 00000289846MR8 00000289847MR6 00000289849MR2 00000289884MR9 00000289886MR4 00000289911MR0 00000289912MR8 00000289913MR6 00000289914MR4 00000289915MR1 00000289975MR5 00000289976MR3 00000290006MR6 00000290007MR4 00000290008MR2 00000290009MR0 00000290010MR8 00000290053MR8 00000290054MR6 00000290055MR3 00000290103MR1 00000290104MR9 00000290105MR6 00000290106MR4 00000290107MR2 00000290127MR0 00000290130MR4 00000290139MR5 00000290140MR3 00000290141MR1 00000290142MR9 00000290143MR7 00000290167MR6 00000290168MR4 00000290169MR2 00000290170MR0 00000290192MR4 00000290193MR2 00000290194MR0 00000290252MR6 00000290254MR2 00000290256MR7 00000290284MR9 00000290285MR6 00000290286MR4 00000290287MR2 00000290288MR0 00000290349MR0 00000290351MR6 00000290354MR0 00000290369MR8 00000290370MR6 00000290371MR4 00000290372MR2 00000290373MR0 00000290407MR6 00000290408MR4 00000293586MR4 00002891887MR7 00000286799MR2 00000287442MR8 00000287443MR6 00000287767MR8 00000288356MR9 00000288358MR5 00000288387MR4 00000288389MR0 00000288437MR7 00000288438MR5 00000288439MR3 00000288607MR5 00000288608MR3 00000288609MR1 00000288796MR6 00000288797MR4 00000288798MR2 00000288853MR5 00000288854MR3 00000288855MR0 00000288873MR3 00000288874MR1 00000288884MR0 00000288885MR7 00000288887MR3 00000289039MR0 00000289040MR8 00000289041MR6 00000289042MR4 00000289043MR2 00000289191MR9 00000289213MR1 00000289259MR4 00000289265MR1 00000289315MR4 00000289316MR2 00000289591MR0 00000289592MR8 00000289653MR8 00000289654MR6 00000910BD57F2 000000105258M0 00000030BD4960 00000806BD3403 00000814BD39ED 00000814BD39F1 000008158D3A3A 00000815BD3A4A 00000816BD3AA6 00000826BD418E 00000830BD495D 00000831BD49EE 0000","4026 (1672 US; 2354 OUS)","An error on the SR Viewer Reporting Tool in which edits can be made on a report and can be saved into incorrect reports. ",5/10/2011,"05/10/2011",3/20/2013,"03/20/2013"
"Food",64292,"Ongoing","GoldCoast Salads","Naples","FL","US","Voluntary: Firm Initiated","E-Mail","AL, FL, GA, MA, MD, NC, NJ, NY, PA, TN and VA","F-1035-2013","Class I","GoldCoast Salads Smoked Salmon Spread (8oz and 16oz in flexible plastic cup with flexible plastic lids - keep refrigerate at 38 or below)","8oz = UPC Code = 33555 00328 exp 03/10/13 S216oz = UPC Code 33555 00128 exp 03/10/13 S2",,"1,567 cases Total","Product may be contaminated with Listeria Monocytogenes",2/1/2013,"02/01/2013",3/6/2013,"03/06/2013"
"Food",64292,"Ongoing","GoldCoast Salads","Naples","FL","US","Voluntary: Firm Initiated","E-Mail","AL, FL, GA, MA, MD, NC, NJ, NY, PA, TN and VA","F-1034-2013","Class I","GoldCoast Salads Lobster & Shrimp Spread (8oz and 16oz in flexible plastic cup with flexible plastic lids - keep refrigerate at 38 or below)","8oz = UPC Code = 33555 00005 exp 02/23/13 L&S116oz = UPC Code = 33555 00004 exp 03/30/13 L&S1",,"2,284 cases total","Product may be contaminated with Listeria Monocytogenes",2/1/2013,"02/01/2013",3/6/2013,"03/06/2013"
"Food",64292,"Ongoing","GoldCoast Salads","Naples","FL","US","Voluntary: Firm Initiated","E-Mail","AL, FL, GA, MA, MD, NC, NJ, NY, PA, TN and VA","F-1033-2013","Class I","GoldCoast Salads Marine Lobster Spread (8oz and 16oz in flexible plastic cup with flexible plastic lids - keep refrigerate at 38 or below)","8oz = UPC Code = 33555 00234 exp 02/14/2013B 6oz = UPC Code = 33555 00124 exp 02/14/2013B ",,"6,919 cases total","Product may be contaminated with Listeria Monocytogenes",2/1/2013,"02/01/2013",3/6/2013,"03/06/2013"
"Food",64292,"Ongoing","GoldCoast Salads","Naples","FL","US","Voluntary: Firm Initiated","E-Mail","AL, FL, GA, MA, MD, NC, NJ, NY, PA, TN and VA","F-1032-2013","Class I","GoldCoast Salads Blue Crab Spread (8oz and 16oz in flexible plastic cup with flexible plastic lids - keep refrigerate at 38 or below)","8oz = UPC Code = 33555 00325 exp 01/31/2013 and exp 02/14/2013B 16oz = UPC Code 33555 00125 exp 01/31/2013 and exp 02/14/2013B",,"6,857 cases total","Product may be contaminated with Listeria Monocytogenes",2/1/2013,"02/01/2013",3/6/2013,"03/06/2013"
"Devices",64294,"Terminated","Medacta Usa Inc","Camarillo","CA","US","Voluntary: Firm Initiated","Letter","Nationwide Distribution including the states of ID, CO, TX, WI, NY, CT, WA, CA, UT, and AZ.","Z-0878-2013","Class II","Versafitcup Impacting Ring Model Number: 01.26.10.0133 (46mm), 01.26.10.0134 (48mm), 01.26.10.0135 (50mm), 01.26.10.0136 (52mm), 01.26.10.0137 (54mm), 01.26.10.0138 (56mm), 01.26.10.0139 (58mm), 01.26.10.0140 (60mm), 01.26.10.0141 (62mm), 01.26.10.0142 (64mm). Designed for cementless use in total hip arthroplasty. ","Reference Number Lot Number Reference Number Lot Number01.26.10.0133: 095920, 096050, 096050A; 01.26.10.0138: 095925, 096055, 096055A; 01.26.10.0134: 095921, 096051, 096051A; 01.26.10.0139: 095926, 096056, 096056A; 01.26.10.0135: 095922, 096052, 096052A; 01.26.10.0140: 095927, 096057, 096057A; 01.26.10.0136: 095923, 096053, 096053A; 01.26.10.0141: 095928, 096058, 096058A; 01.26.10.0137: 095924, 096054, 096054A; 01.26.10.0142: 095929, 096059, 096059A.",,"293 units","Medacta USA is recalling Versafitcup Impacting Ring because the impaction ring may not fit properly in the implant shell in all cases. This could result in surgical delay potentially increasing possible complications under anesthesia, having to ream up to a larger shell size leaving less bone than planned and repositiong/removal of the shell after initial impaction.",1/15/2010,"01/15/2010",3/6/2013,"03/06/2013"
"Food",64295,"Ongoing","Farmers Cooperative Creamery","McMinnville","OR","US","Voluntary: Firm Initiated","Telephone","Product was directly distributed in California, Oregon, and Washington.","F-1193-2013","Class III","Salted Print Butter, Rose Valley brand. Product is packaged in 1 lb. unit package, 36 units per case. The UPC is 0 32395 09322 0. The product is labeled in parts: ''***ROSE VALLEY***SWEET CREAM BUTTER***NET WT. 16OZ***MFD. BY FARMERS CO-OPERATIVE CREAMERY***McMINNVILLE***ORE***97128***AA GRADE***KEEP REFRIGERATED***INGREDIENTS: CREAM (MILK), SALT***''.","CH 024-13. Expiration 10/30/13",,"9,900 lbs (or 275 cases, 36 lb. per case)","Salted Print Butter, Rose Valley brand, is recalled. The Appendix N procedure was not followed and the firm used the milk to process into butter without the confirmation negative antibiotic test result.",2/5/2013,"02/05/2013",3/20/2013,"03/20/2013"
"Biologics",64296,"Terminated","Blood Center Hammond Laboratory (the)","Hammond","LA","US","Voluntary: Firm Initiated","Telephone","LA","B-1216-13","Class II","Red Blood Cells Leukocytes Reduced Irradiated","W067112078593; W067112060745",".","2 unit","Blood products, which were incompletely irradiated, were distributed.",11/26/2012,"11/26/2012",5/29/2013,"05/29/2013"
"Food",64297,"Ongoing","Diversified Foods & Seasonings, Inc.","Mandeville","LA","US","Voluntary: Firm Initiated","E-Mail","TN & MS","F-0991-2013","Class I","CULINARY Creations (brand) CHEESY BROCCOLI SOUP, 3F3080, CONTAINS: 20/2 LB. CHUBS, NET WT. 40 LBS. 91816 KG), DIVERSIFIED FOODS AND SEASONINGS, INC, 1115 N. CAUSEWAY BLVD. STE.200, MANDEVILLE, LA 70471 1-800-835-3374, FOR INSTITUTIONAL USE ONLY, UPC 00732628330803","100512",,"189/ 40 lb cases","The firm received a complaint of a consumer finding shrimp in Broccoli Cheese Soup.",2/6/2013,"02/06/2013",2/20/2013,"02/20/2013"
"Drugs",64298,"Ongoing","Aaron Industries Inc","Lynwood","CA","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Nationwide","D-186-2013","Class III","Rite Aid Maximum Strength Tussin Cough & Cold Mucus Relief CF, (dextromethorphan HBr 10 mg, guaifenesin 200 mg, phenylephrine HCI 5 mg, 4 FL. OZ./12 PK (UPC Code: 0-11822-57307-8) and 8 FL.OZ./12 PK (UPC Code: 0-11822-57313-9), Distributed by: Rite Aid, Camp Hill, PA, 17011","Lot# 68089, 68415, 70046, 700516, 70665, 71157, 71704, 80795; FP-38-081-57313; FP-38-041-57307",,"35,652 bottles (2,971 cases)","Presence of Precipitate; white substance confirmed as Guaifenesin, an active ingredient was observed in some bottles. If the product is shaken or warmed the white particles goes into the solution.",1/18/2013,"01/18/2013",3/13/2013,"03/13/2013"
"Drugs",64298,"Ongoing","Aaron Industries Inc","Lynwood","CA","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Nationwide","D-185-2013","Class III","Well at Walgreens Wal-Tussin CF Max, MAXIMUM STRENGTH ADULT NON-DROWSY, Multi-Symptom Cold, (dextromethorphan HBr 10 mg, guaifenesin 200 mg, phenylephrine HCI 5 mg), 8 FL OZ (237 mL) bottles, Distributed by: Walgreen Co, Deerfield, IL 60015 ---- NDC 0363-0229-08","Lot# 80798; FP-49-081-14870",,"6,108 bottles (509 cases)","Presence of Precipitate; white substance confirmed as Guaifenesin, an active ingredient was observed in some bottles. If the product is shaken or warmed the white particles goes into the solution.",1/18/2013,"01/18/2013",3/13/2013,"03/13/2013"
"Drugs",64298,"Ongoing","Aaron Industries Inc","Lynwood","CA","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Nationwide","D-187-2013","Class III","Select Brand Cough Control CF Max, Maximum Strength for MUCUS RELIEF, (dextromethorphan HBr 10 mg, guaifenesin 200 mg, phenylephrine HCI 5 mg), 4 fl.oz 12pk (NDC 15127-025-04; UPC Code: 0-15127-02535-5), Distributed by: Select Brand Distributors, Pine Bluff, AR 71603 USA.","Lot# 71648, 68088; FP-47-041-02535",,"5,676 bottles (473 cases)","Presence of Precipitate; white substance confirmed as Guaifenesin, an active ingredient was observed in some bottles. If the product is shaken or warmed the white particles goes into the solution.",1/18/2013,"01/18/2013",3/13/2013,"03/13/2013"
"Drugs",64298,"Ongoing","Aaron Industries Inc","Lynwood","CA","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Nationwide","D-188-2013","Class III","Wal-Mart Equate Tussin CF Adult Maximum Strength, Multi-Symptom Cold, (dextromethorphan HBr 10 mg, guaifenesin 200 mg, phenylephrine HCI 5 mg), 8 FL OZ (235 mL) (NDC 49035-229-08; UPC Code: 6-81131-03884-30), Distributed by: Wal-Mart Stores, Inc., Bentonville, AR 72712.","Lot# 81198, 82183, 80797; FP-44-081-03884",,"43,464 bottles (3,622 cases)","Presence of Precipitate; white substance confirmed as Guaifenesin, an active ingredient was observed in some bottles. If the product is shaken or warmed the white particles goes into the solution.",1/18/2013,"01/18/2013",3/13/2013,"03/13/2013"
"Biologics",64299,"Terminated","Community Blood Centers of South Florida, Inc.","Lake Worth","FL","US","Voluntary: Firm Initiated","Letter","TN, FL","B-1219-13","Class II","Fresh Frozen Plasma","W036810186644",".","1 unit","Blood products, which was collected from a donor in which donor suitability was not adequately determined, were distributed.",1/28/2013,"01/28/2013",5/29/2013,"05/29/2013"
"Biologics",64299,"Terminated","Community Blood Centers of South Florida, Inc.","Lake Worth","FL","US","Voluntary: Firm Initiated","Letter","TN, FL","B-1217-13","Class II","Red Blood Cells","W036810186644",".","1 unit","Blood products, which was collected from a donor in which donor suitability was not adequately determined, were distributed.",1/28/2013,"01/28/2013",5/29/2013,"05/29/2013"
"Biologics",64299,"Terminated","Community Blood Centers of South Florida, Inc.","Lake Worth","FL","US","Voluntary: Firm Initiated","Letter","TN, FL","B-1218-13","Class II","Platelets Pooled Leukocytes Reduced","W036810811695",".","1 unit","Blood products, which was collected from a donor in which donor suitability was not adequately determined, were distributed.",1/28/2013,"01/28/2013",5/29/2013,"05/29/2013"
"Biologics",64300,"Terminated","Blood Centers of the Pacific - Irwin Center","San Francisco","CA","US","Voluntary: Firm Initiated","Telephone","CA","B-1343-13","Class III","Blood Products - Other","W117011322802L- part 1; W117011322802L- part 2 ",".","2 units","Blood products, failed to meet the minimum specification for deglycerolized components, were distributed.",1/25/2013,"01/25/2013",5/1/2013,"05/01/2013"
"Biologics",64301,"Terminated","Bio-Blood Components, Inc.","Hammond","IN","US","Voluntary: Firm Initiated","E-Mail","TN","B-1224-13","Class III","Source Plasma","12HINC1435; 12HINC0838",".","2 units","Blood products, collected from a donor who was listed as a permanent deferral, were distributed.",1/10/2013,"01/10/2013",5/29/2013,"05/29/2013"
"Biologics",64302,"Terminated","The American National Red Cross South Carolina Region","Columbia","SC","US","Voluntary: Firm Initiated","Other","SC","B-1223-13","Class III","Blood and Blood Products for Reprocessing","36FP39434",".","1 unit","Blood product, which was collected from a donor in which donor suitability was not adequately determined, was distributed.",12/21/2012,"12/21/2012",5/29/2013,"05/29/2013"
"Devices",64303,"Ongoing","Ultradent Products, Inc.","South Jordan","UT","US","Voluntary: Firm Initiated","Letter","USA Nationwide Distribution including the states of CA, AZ, CO and WA.","Z-0876-2013","Class III","Avex CX Suite, Avex CX 0.22 UL4,5 HK REF #224-017, Product Usage: Avex CX ceramic brackets are formed with 99.9% pure alumina oxide. The indicated use of the Avex CX ceramic bracket is the mechanical movement of natural teeth in conjunction with other components designed to attach to the brackets.","Lot R131360",,"124","Orthodontic brackets distributed was incorrectly labeled.",2/8/2013,"02/08/2013",3/6/2013,"03/06/2013"
"Devices",64304,"Ongoing","Veridex, LLC","Raritan","NJ","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution - USA Nationwide and the countries of Australia, Canada, China, India, Japan, Singapore, England, France, Germany, Italy and Spain.","Z-1950-2013","Class II","CELLTRACKS ANALYZER II (Software Version 2.5.1 & Below. Product Usage: The CELLTRACKS AUTOPREP System is a general purpose laboratory instrument used with immunomagnetic reagents that capture and enrich target cells, and labeling reagents that differentiate cells in whole blood. Cell analyzers such as the CellTracks Analyzer II, CellSpotter System, flow cytometers or microscopes may be used for cell identification and enumeration. The system is fit for in vitro diagnostic use. In the CellTracks Analyzer II software 2.5.1 release notes Pub. No. J40136EN issued 2012-03-26 page 1, the document states that the edit patient sample information screen now includes a patient information section, a new feature unique to software 2.5.1. This section provides a drop down for patient race and cancer type. There are also separate fields for first and last name for both the physician and patient. There is no mention of the drop down patient ID box on the right side of the user interface which auto-populates previous sample data. ","CELLTRACKS ANALYZER II (Software Version 2.5.1 & Below). Product Code: CT1476B (9555).",,"US: 70 Units; Ex-US 76 Units","Veridex, LLC has received a report that a patient's demographics were incorrectly associated with another patient's identification (PID) number. The purpose of this notification is to inform you of the issue and provide instructions to help prevent an occurrence on your CELLTRACKS AUTOPREP System and CELLTRACKS ANALYZER II. ",12/28/2012,"12/28/2012",8/21/2013,"08/21/2013"
"Devices",64304,"Ongoing","Veridex, LLC","Raritan","NJ","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution - USA Nationwide and the countries of Australia, Canada, China, India, Japan, Singapore, England, France, Germany, Italy and Spain.","Z-1949-2013","Class II","CELLTRACKS AUTOPREP System (Software Version 2.4.1 & Below. Product Usage: The CELLTRACKS AUTOPREP System is a general purpose laboratory instrument used with immunomagnetic reagents that capture and enrich target cells, and labeling reagents that differentiate cells in whole blood. Cell analyzers such as the CellTracks Analyzer II, CellSpotter System, flow cytometers or microscopes may be used for cell identification and enumeration. The system is fit for in vitro diagnostic use. In the CellTracks AutoPrep System software 2.4.1 release notes Pub. No. J40135EN issued 2012-03-26 page 2, the document states that a new feature unique to software 2.4.1 allows the used to modify a batch in a new way. The user has additional optional fields in the edit sample information dialog box that allows one to enter expanded sample and patient information. The user can also edit the patient management setting for selected samples if not all samples have the same designation. ","CELLTRACKS AUTOPREP System (Software Version 2.4.1 & Below). Product Code: CT4297B (9541). ",,"US: 82 Units; Ex-US 78 Units.","Veridex, LLC has received a report that a patient's demographics were incorrectly associated with another patient's identification (PID) number. The purpose of this notification is to inform you of the issue and provide instructions to help prevent an occurrence on your CELLTRACKS AUTOPREP System and CELLTRACKS ANALYZER II. ",12/28/2012,"12/28/2012",8/21/2013,"08/21/2013"
"Drugs",64305,"Ongoing","Teva Pharmaceuticals USA, Inc.","Sellersville","PA","US","Voluntary: Firm Initiated","Letter","NC","D-237-2013","Class II","CLONAZEPAM ORALLY DISINTERGRATING Tablets, USP, 0.5 mg, 60 tablets (10 blister cards of 6 tablets each), TEVA PHARMACEUTICALS USA, Sellersville PA 18960, NDC #0555-0096-96","Lot # 32900136A, Exp. 05/14",".","3 boxes ","Failed Content Uniformity Specifications: Recall is being carried out due to an out-of-specification result for content uniformity.",2/7/2013,"02/07/2013",4/10/2013,"04/10/2013"
"Devices",64306,"Ongoing","Stryker Howmedica Osteonics Corp.","Mahwah","NJ","US","Voluntary: Firm Initiated","Letter","Nationwide Distribution.","Z-0919-2013","Class II","Command Instrument Broach Handle. Used in Total Hip Arthroplasty. Catalog Number: 6266-0-100","Catalog Number: 6266-0-100Lot Code: RD6W017, RD7L234X, RD7L234, RD7L235, RD5T305A, RD6W017J, RD6W017A, RD5T307, RD5T305T, RD5T305M, RD5T305L, RD5T306X, RD5T305, RD5T306",,"48 units","Stryker Orthopaedics has received reports from the field indicating handle fracture and subsequent disassociation of cam assembly subcomponents during use.",12/20/2012,"12/20/2012",3/20/2013,"03/20/2013"
"Devices",64307,"Ongoing","Animas Corporation","West Chester","PA","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution-USA (nationwide) including Washington, DC, Puerto Rico, US Virgin Island and the states of AK, AL, AR, AZ, CA, CO, CT, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV, and WY, and the countries of Austria, Australia, Bermuda, Canada, New Zealand, Czech Republic, Italy, France, Finland, Hungary, Israel, United Kingdom, Spain, Sweden, Norway, Denmark, Germany, Mexico and Ireland.","Z-0836-2013","Class III","Animas(R) 2020, Animas(R) IR 1250 (1200 plus), Animas(R) IR 1200 Insulin Infusion Pumps Indicated for continuous subcutaneous infusion of insulin. ","All Animas 2020, IR1250 and IR1200 Pump Models - Part Numbers 101370-00, 101371-00, 101372-00, 101374-00, 101375-00, 100380-00, 100381-00, 100382-00, 100384-00, 100385-00, 100450-00, 100210-00, 100211-00, 100212-00, 100250-00, 100251-00, 100252-00, 100200-00, 100201-00, 100202-00, 100170-00, 100171-00 and 100172-00.",".","37,998","Due to an internal calendar date limit (December 31, 2015) these pumps will cease to operate on January 1, 2016, and will result in a call service alarm that is displayed on the pump display.",12/17/2012,"12/17/2012",2/27/2013,"02/27/2013"
"Devices",64308,"Ongoing","Stryker Howmedica Osteonics Corp.","Mahwah","NJ","US","Voluntary: Firm Initiated","Letter","USA Nationwide Distribution","Z-1052-2013","Class I","ShapeMatch Cutting Guides Product Usage: The ShapeMatch Cutting Guides are intended to be used as patient-specific surgical instrumentation to assist in the positioning of total knee arthroplasty components intraoperatively and in guiding the marking of bone before cutting.","Catalog No: TR7100-L and TR7100-R Lot Code: All",".","7868 units","With regard ShapeMatch Cutting Guides using MRI Imaging, Stryker Orthopaedics has become aware that there are potential issues associated with internal processes for planning cases and producing ShapeMatch Cutting Guides.",11/6/2012,"11/06/2012",4/24/2013,"04/24/2013"
"Veterinary",64309,"Ongoing","International Ingredient Corp","Fenton","MO","US","Voluntary: Firm Initiated","Telephone","TX","V-300-2013","Class I","Brewtech Dried Brewers Yeast, manufactured by International Ingredient Corporation, P.O. Box 26377, St. Louis, MO 63026 sold in 50 lb. bags, 2000 lb. bulk totes, and 2205 lb. bulk totes.","Lot codes: FN-14-Z1, FN-15-Z1, FN-16-Z1, FN-17-Z1, FN-21-Z1, FN-22-Z1, FN-23-Z1",,"281,745 total pounds","The product has the potential to be contaminated with salmonella.",2/1/2013,"02/01/2013",9/4/2013,"09/04/2013"
"Devices",64310,"Ongoing","Becton Dickinson & Co.","Sparks","MD","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution - USA including CA, FL, IN, IL, KS, NY, OH, OR, PA, TX, and WI and the country of Belgium","Z-0976-2013","Class II","BD MAX PCR Cartridges Catalog #437519, box of 24 cartridges labeled in part:***BD MAX PCR Cartridges, GeneOhm Sciences Canada, Inc. 2555 boul du Parc-Technologique, Quebec, Canada G1P 4S5***BD Max Group B Streptococcus (GBS) Assay is an in vitro diagnostic (IVD) test for detection of GBS DNA in Lim Broth cultures. The BD MAX'' PCR Cartridge is a consumable required for the BD MAX'' System.","Lot/Exp. date: 2235001 2014-08-22",," 27 boxes/648 cartridges","Cartridges are not sealing properly during PCR testing and may cause false results, indeterminates and/or invalid runs.",12/11/2012,"12/11/2012",4/3/2013,"04/03/2013"
"Food",64311,"Ongoing","Sage Creek Inc","The Dalles","OR","US","Voluntary: Firm Initiated","Telephone","Western US","F-1314-2013","Class II","Canned Apricot in Light Syrup or canned Apricot in Heavy Syrup. The PDP reads ''HOOD-CREST APRICOTS UNPEELED HALVES IN LIGHT SYRUP NET WT. 28 OZ. (1LB. 12 OZ.) 793G''. The back panel reads in part ''*** INGREDIENTS: APRICOTS, WATER, SUGAR. MUIRHEAD CANNING CO. The Dalles, Ore. 97058***'' The UPC is 7 88637 01031 8. The PDP reads ''HOOD-CREST APRICOTS UNPEELED HALVES IN HEAVY SYRUP NET WT. 29 OZ. (1 LB. 13 OZ.) with the back panel reading in part ''*** INGREDIENTS: APRICOTS, WATER, SUGAR Packed by MUIRHEAD CANNING CO. The Dalles, Ore. 97058***'' There is no UPC on the label.","Apricots in Heavy Syrup has a can code: paterson 195 12:24. This code is interpreted as: Paterson apricot type, Julian date 1955, and processing time. Apricots in Light Syrup's can code: PATERSON 195 12:12.",,"firm is unable/unwilling to provide this information","Potentially under processed and reports of swollen and bursting cans as well as fruit browning quickly after opening the can and undercooked (firm) fruit from consumers.",2/8/2013,"02/08/2013",4/17/2013,"04/17/2013"
"Food",64311,"Ongoing","Sage Creek Inc","The Dalles","OR","US","Voluntary: Firm Initiated","Telephone","Western US","F-1313-2013","Class II","Canned Pear Halves in Light Syrup or canned Pear Halves in Heavy Syrup. The PDP reads ''HOOD-CREST HALVES BARTLETT PEARS IN HEAVY SYRUP NET WT. 28 OZ. (1 LB. 12 OZ.) 793G'' and the back panel reads in part ''***INGREDIENTS: PEARS WATER, SUGAR. Packed by MUIRHEAD CANNING CO. The Dalles, Ore. 97058***'' There is no UPC on the label. For the light syrup the PDP reads ''HOOD-CREST HALVES BARTLETT PEARS IN LIGHT SYRUP NET WT. 28 OZ. (1LB. 12 OZ.) 793G'' The back panel reads in part ''***INGREDIENTS: PEARS, WATER, SUGAR. MUIRHEAD CANNING CO. The Dalles, Ore. 97058***'' The UPC on the label is 7 88637 01071 4.","Pear Halves in Light Syrup has a can code: bartlett 285 12:24. This code is interpreted as: Bartlett type, Julian date 285, and processing time. The can code for Pears in Heavy Syrup is: BARTLETT 285 12:12",,"firm unwilling/unable to provide","Potentially under processed and reports of swollen and bursting cans as well as the fruit turning brown shortly after opening and the fruit is undercooked (firm) from consumers.",2/8/2013,"02/08/2013",4/17/2013,"04/17/2013"
"Food",64311,"Ongoing","Sage Creek Inc","The Dalles","OR","US","Voluntary: Firm Initiated","Telephone","Western US","F-1312-2013","Class II","Canned Peach Slices in Light Syrup or canned Peach Slices in Heavy Syrup or canned Peach halves in Heavy Syrup. The PDP reads ''HOOD-CREST ELBERTA PEACHES YELLOW FREESTONE SLICES IN LIGHT SYRUP NET WT. 28 OZ. (1LB. 12 OZ.) 793G'' The back panel reads in part ''***INGREDIENTS: PEACHES, WATER, SUGAR. MUIRHEAD CANNING CO. The Dalles, Ore. 97058***'' The UPC on the label reads 7 88637 01111 7. The PDP reads ''HOOD-CREST ELBERTA PEACHES YELLOW FREESTONE SLICES IN HEAVY SYRUP NET WT. 28 OZ. (1 LB. 12 OZ.) 793G'' The back panel reads in part ''***INGREDIENTS: PEACHES, WATER, SUGAR. Packed by MUIRHEAD CANNING CO. The Dalles, Ore. 97058. There is no UPC on the label. The PDP reads ''HOOD-CREST ELBERTA PEACHES YELLOW FREESTONE HALVES IN HEAVY SYRUP NET WT. 28 OZ. (1LB. 12 OZ.) 793G'' The back panel reads in part ''*** INGREDIENTS: PEACHES, WATER, SUGAR MUIRHEAD CANNING CO. The Dalles, Ore. 97058***'' There is no UPC on the label.","Peach Slices in Light Syrup has a can code: fairtime 264 12:24.Peaches Slices in Heavy Syrup has a can code: elberta 265 12:24. These codes are interpreted as: Fairtime or Elberta peach type, Julian date 264 or 265, and processing time. The firm has not provided the code information for the peach halves.",,"firm unwilling/unable to provide","potentially under processed and reports of swollen and bursting cans as well as discoloring fruit soon after opening the can and the fruit is undercooked (too firm), from consumers.",2/8/2013,"02/08/2013",4/17/2013,"04/17/2013"
"Drugs",64312,"Ongoing","Watson Laboratories Inc","Corona","CA","US","Voluntary: Firm Initiated","Letter","Nationwide and Puerto Rico","D-203-2013","Class II","Meprobamate, Tablets USP, 200 mg, 100 tablets; Rx only; Manufactured By: Watson Laboratories, Inc., Corona, CA 92800 USA; 173266; . Distributed by: Watson Pharma, Inc., NDC 9591-5239-01","386585A, Exp. 02/13; 429104A, Exp. 06/13; 474487A, Exp. 11/13; 491671A, Exp.01/14. ",".","9,824 bottles","Failed Impurities/Degradation Specifications: Watson Laboratories Inc. is recalling meprobamate because an out of specification result for an impurity diphenyl sulfone .",2/8/2013,"02/08/2013",3/27/2013,"03/27/2013"
"Drugs",64312,"Ongoing","Watson Laboratories Inc","Corona","CA","US","Voluntary: Firm Initiated","Letter","Nationwide and Puerto Rico","D-204-2013","Class II","Meprobamate; Tablets USP, 400 mg, 100 tablets; Rx only; Manufactured By: Watson Laboratories, Inc., Corona, CA 92800 USA; 173266; . Distributed by: Watson Pharma, Inc., NDC 0591-5238-01 ","387879A, Exp. 02/13; 429105A, Exp. 06/13; 474488A, Exp. 11/13; 491672A, Exp. 01/14; 529095A, Exp. 04/14",".","20,587 bottles","Failed Impurities/Degradation Specifications: Watson Laboratories Inc. is recalling meprobamate because an out of specification result for an impurity diphenyl sulfone .",2/8/2013,"02/08/2013",3/27/2013,"03/27/2013"
"Devices",64313,"Ongoing","Stryker Spine","Allendale","NJ","US","Voluntary: Firm Initiated","Letter","Nationwide Distribution including the states of AL, AZ, CA, CO, FL, GA, IA, IL,IN, KS, LA, MA, MD, MI, MO, MN, NC, NY. OH, OK, OR, PA, TN, TX, UT and WI.","Z-0893-2013","Class II","Stryker XIA 3 Iliac Screwdriver, 3-PCS. The XIA 3 Iliac Screwdriver is used to drive XIA 3 closed head Monoaxial and closed head Polyaxial screws into the Ilium. This device is not intended to sustain or support life. ","Catalog Number: 48231326. Lot Number: 10G637; 10G638 and 10E852.",,"46 units US","Complaints have been reported indicating that surgeons have experienced unthreading of the screwdrivers outer shafts during use. ",12/27/2012,"12/27/2012",3/6/2013,"03/06/2013"
"Food",64314,"Ongoing","Inventure Foods, Inc.","Bluffton","IN","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","AZ, KY, IL, NJ, GA, FL, MN, CA, CO, and TX.","F-1135-2013","Class II","Jamba Multigrain Fruit Chips( Blueberry) 5ozx12 and 1.5ozx55"," 5ozx12 size: Date code: 7/13/2013 and SKU: 90013 and 90013R. 1.5ozx55 size: Date code: 7/13/2013 and 7/14/2013 and SKU: 90011 and 90012. ",,"1252 cases","On 2/6/2013 the firm received a recall notification letter from Dakota Milling informing that they are voluntarily recalled the 41440 Boulder 7 Grain Flour blends because of the potential metal contamination.",2/8/2013,"02/08/2013",3/20/2013,"03/20/2013"
"Food",64314,"Ongoing","Inventure Foods, Inc.","Bluffton","IN","US","Voluntary: Firm Initiated","Letter","AZ, KY, IL, NJ, GA, FL, MN, CA, CO, and TX.","F-1136-2013","Class II","Jamba Multigrain Fruit Chips (Cranberry) 5ozx12","Date code: 7/14/2013 and 10/21/13SKU: 90014 and 90014R ",,"134 cases","On 2/6/2013 the firm received a recall notification letter from Dakota Milling informing that they are voluntarily recalled the 41440 Boulder 7 Grain Flour blends because of the potential metal contamination.",2/8/2013,"02/08/2013",3/20/2013,"03/20/2013"
"Food",64315,"Terminated","DZH Import & Export Inc.","Brooklyn","NY","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","New York City","F-1371-2013","Class I","Dried mushrooms sold under the following brand names: 1) CURIOSITY OF DASHAN brand DRIED MUSHROOM, N.W. 100G (3.5 OZ), UPC 6 939457 003484, Product of China --- Imported By: DZH Import & Export Inc. 70-21 51 Avenue, Woodside, NY 11377 Tel: 718-205-8312 Fax: 718-205-8146 --- Nutrition Facts: Serving Size 1/2 cup (7g dry) (30g reconstituted) -- Servings Per Container about 4. --- The product is packed on a plastic tray inside a plastic bag. 2) MOUNTAINS brand DRIED MUSHROOM, NET WT: 35G (1.23 OZ) , UPC 6 931653 104064, Product of China --- Imported By: DZH Import & Export Inc. 70-21 51 Avenue, Woodside, NY 11377 Tel: 718-205-8312 Fax: 718-205-8146 --- Nutrition Facts: Serving Size 100g -- Servings Per Container 3 --- The product is packed on a plastic tray inside a plastic bag.","1) BEST BEFORE: MAY 3rd, 2013. 2) Best Before: Nov.30, 2013.",,"1) 15 cases (50 x 35 gram packages per case) 2) unknown","1) The product contained undeclared sulfites (7984 ppm) based on sampling and analysis by New York State Department of Agriculture & Markets. 2) The product contained undeclared sulfites (7943 ppm) based on sampling and analysis by New York State Department of Agriculture & Markets.",2/8/2013,"02/08/2013",5/8/2013,"05/08/2013"
"Devices",64316,"Ongoing","Oculus Innovative Sciences Inc","Petaluma","CA","US","Voluntary: Firm Initiated","E-Mail","''Nationwide Distribution - One distributor in PA''","Z-0890-2013","Class II","Atrapro Antipruritic Hydrogel, 1.5 oz gel tube, 4 Net wt/ 1.5 oz..RX only, Professional Sample, Not for Sale. Pre-printed tube: MS31071, Shelf carton: PL51091-08 Atrapro Antipruritic HydroGel is indicated to manage and relieve the burning, itching and pain experienced with various types of dermatoses, including radiation dermatitis and atopic dermatitis.","Lot 12A0012, Exp 2/2013; Lot 12A0013, Exp 2/2013: Lot 12A1116, Exp 2.2013; Lot 12A1119, Exp 2/2013; Lot 12B1144, Exp 3/2013; Lot 12B1148, Exp 3/2013; Lot 12C1157, Exp 4/2013; Lot 12E190. Exp 6/2013; Lot 12E194, Exp 6/2013; Lot 12E198, Exp 6/2013; Lot 12E202. Exp 6/2013; Lot 12E208, Exp 6/2013; Lot 12E211, Exp 6/2013.",,"56,566 1.5 oz tubes","Out of specification result - stability test failure of free available chlorine (FAC) which functions as a preservative for the hydrogel. The 13 month test result obtained was 4 ppm FAC and the stability specification is >10 ppm FAC.",2/12/2013,"02/12/2013",3/6/2013,"03/06/2013"
"Drugs",64317,"Ongoing","Actavis Pharmaceuticals","Morristown","NJ","US","Voluntary: Firm Initiated","Letter","Nationwide","D-175-2013","Class III","buPROPion Hydrochloride Extended - Release Tablets (XL) 300 mg, 30 tablet bottles, Rx Only, NDC 67767-142-30 Actavis Distributed by: Actavis South Atlantic LLC Sunrise, FL 33325 Packaged by by: America Health Packaging Columbus, OH 43217","Lot CB1D05A, ",,"14,856 bottles ","Failed Dissolution Specifications; 8-hours for the 18-month stability testing point.",1/4/2013,"01/04/2013",3/6/2013,"03/06/2013"
"Devices",64318,"Ongoing","Integra LifeSciences Corp.","Plainsboro","NJ","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution - USA and the countries of Austria, Australia, Bangladesh, Belgium, Bulgaria, Brazil, Switzerland, Canada, China, Costa Rica, Czech Republic, Germany, Dominican Republic, Egypt, Emirates, Spain, Finland, France, Great Britian, Hong Kong, Hungary, Indonesia, Ireland, Israel, India, Italy, Japan, Korea (South), Kuwait, Lebanon, Sri Lanka, Latvia, Macedonia, Mexico, Malaysia, Netherlands, Philippines, Pakistan, Poland, Portugal, Qatar, Serbia, Saudi Arabia, Singapore, Slovenia, Thailand, Tunisia, Taiwan, United Arab, Viet Nam and South Africa.","Z-0920-2013","Class II","Integra CUSA excel. CEM Nosecone for CUSA EXcel System. The CEM Nosecone is intended for use CUSA Excel/CUSA Excel + Ultrasonic Surgical Aspiration System, CUSA handpiece, and Covidien Force FX Electrosurgical Generator. Used in surgical procedures where combined ultrasonic dissection and electrosurgical coagulation is desired, either simultaneously or independently. ","CEM Nosecone Catalogue No. C6623 Lot numbers: 1092855, 1093129, 1100436, 1100437, 1101217, 1101328, 1103393, 1104265, 1105067, 1110311, 1110892, 1112182, 1112183, 1114112, 1114655, 1115225, 1115499, 1115500, 1120771, 1121141, 1121142, 1121383, 1121627, 1122258, 1122259, 1123049 and 1130710. CEM Nosecone, Catalogue No. C6636: 1091431, 1091679, 1091680, 1093475, 1095103, 1095416, 1095417, 1100242, 1100434, 1100435, 1101094, 1101218, 1101219, 1103104, 1103395, 1103849, 1103849, 1103850, 1103852, 1103917, 1103918, 1103922, 1104257, 1104263, 1105071, 1110475, 1110476, 1110978, 1111490, 1111493, 1112187, 1112188, 1112212, 1113179, 1113180, 1113663, 1114357, 1114358, 1114659, 1114660, 1115039, 1115502, 1115504, 1115505, 1120776, 1120777, 1121167, 1121168, 1121169, 1121565, 1121566, 1121567, 1122344, 1123051, 1123052, 1123508, 1123511 and 1124053. ",,"USA 6,190, EU 22,972 and ROW 288 units","There is a potential for erosion of the CUSA EXcel tip used with the Nosecone. Specifically, the potential for tip erosion occurs when using a CUSA CEM Nosecone if the side of the tip, rather than the annulus of the tip, is in contact with the tissue. This erosion can potentially lead to tip breakage. There were no reports of a patient injury associated with these complaints. ",1/7/2013,"01/07/2013",3/20/2013,"03/20/2013"
"Devices",64319,"Ongoing","Varian Medical Systems, Inc. Oncology Systems","Palo Alto","CA","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution - USA Nationwide","Z-0867-2013","Class II","Varian Eclipse Treatment Planning System for Radiotherapy; Model Number: H48. In addition, the Eclipse Proton Eye algorithm is specifically indicated for planning proton treatment of neoplasms of the eye.","H480044 , H481353 , H482733 , H484585 , H485948 , H480045 , H481354 , H482734 , H484634 , H486024 , H480105 , H481433 , H482765 , H484673 , H486032 , H480106 , H481436 , H482827 , H484677 , H486093 , H480159 , H481437 , H482858 , H484680 , H486094 , H480160 , H481451 , H482859 , H484745 , H486095 , H480247 , H481452 , H482860 , H484746 , H486114 , H480301 , H481453 , H482888 , H484747 , H486140 , H480373 , H481454 , H482889 , H484753 , H486209 , H480374 , H481460 , H482897 , H484830 , H486291 , H480378 , H481461 , H483087 , H484842 , H486369 , H480379 , H481462 , H483204 , H484856 , H486385 , H480408 , H481483 , H483345 , H484950 , H486412 , H480409 , H481532 , H483350 , H484951 , H486442 , H480410 , H481533 , H483351 , H48SOOS , H486473 , H480422 , H481581 , H483352 , H485006 , H486486 , H480471 , H481582 , H483353 , H485090 , H486498 , H480477 , H481601 , H483354 , H485091 , H486499 , H480493 , H481627 , H483406 , H485113 , H486543 , H480566 , H481639 , H483442 , H485127 , H486579 , H4806Sl , H481685 , H483452 , H485143 , H486580 , H480692 , H481766 , H483592 , H485144 , H486615 , H480725 , H481781 , H483617 , H485145 , H486616 , H480764 , H481807 , H483666 , H485162 , H486688 , H480765 , H481815 , H483695 , H485244 , H486689 , H480766 , H481834 , H483696 , H485268 , H486694 , H480794 , H481857 , H483698 , H485308 , H486703 , H480808 , H481879 , H483723 , H485321 , H486716 , H480819 , H481923 , H483724 , H485322 , H486759 , H480820 , H481924 , H483725 , H485359 , H486760 , H480821 , H482166 , H483732 , H485442 , H486858 , H480917 , H482167 , H483733 , H485471 , H486859 , H480918 , H482168 , H483757 , H485481 , H486860 , H481054 , H482181 , H483758 , H485536 , H486861 , H481057 , H482182 , H483759 , H485537 , H486885 , H481112 , H482191 , H483767 , H485541 , H486895 , H481114 , H482192 , H483768 , H485557 , H486896 , H481119 , H482193 , H483840 , H485573 , H486938 , H481120 , H482194 , H483841 , H485580 , H486939 , H481133 , H482243 , H483871 , H485581 , H486941 , H481138 , H482244 , H483872 , H485582 , H4869",".","1168 units","Varian has identified an anomaly with the Eclipse Treatment Planning (for radiotherapy treatments) where the calculation of dose dynamic plans containing different energy fields is incorrect when the Pencil Beam Convolution 11.0 algorithm (PBC 11.0) is used. ",1/28/2013,"01/28/2013",2/27/2013,"02/27/2013"
"Devices",64320,"Ongoing","Diagnostica Stago, Inc.","Parsippany","NJ","US","Voluntary: Firm Initiated","E-Mail","Worldwide Distribution - USA and Canada.","Z-0951-2013","Class II","Vial Label: 1) LIATEST VWF:Ag Buffer - 5 ml Diagnostica Stago 2) LIATEST VWF:Ag Latex + 4 ml R3 Diagnostica Stago 3) LIATEST VWF:Ag Latex Diluent 4 mL Diagnostica Stago Model, catalogue, number 00518 - 58978 - 58979 Kit Label: LIATEST VWF:Ag DIAGNOSTICA STAGO S.A.S. 92600 Asnires sur Seine (France) Coagulation Assay","Lot/Unit Numbers : Combination of All STA-R/ STA-R EVOLUTION and lots of STA - LIATEST VWF: AG are involved. Lot Number Expiry date 108128 2013-03 108512 2013-04 108778 2013-07 109415 2013-10 109591 2014-01 ",,"2901 kits","Diagnostica Stago has confirmed that sometimes the delta OD measured can be changed leading to a lowered percentage result. ",1/28/2013,"01/28/2013",3/20/2013,"03/20/2013"
"Devices",64321,"Ongoing","Greiner Bio-One North America, Inc.","Monroe","NC","US","Voluntary: Firm Initiated","Letter","US Nationwide Distribution in the states of FL, IL, KY, NY, NC, PA, OH, TX, VA","Z-0835-2013","Class II","VACUETTE Safety Blood Collection Set + Luer Adapter, 23x12'' Safety Blood Collect LA Product, Item number 450096. Usage: The Safety Blood Collection Set is used in routine venipuncture procedures.","Lot No. 12H27",".","192,000 pieces (192 cases)","The VACUETTE Safety Blood Collection Set + Luer Adapter may display leaking (small droplets) during use due to a crack on the luer connector piece.",2/1/2013,"02/01/2013",2/27/2013,"02/27/2013"
"Devices",64322,"Ongoing","Mc-NEIL-PPC, Inc.","Skillman","NJ","US","Voluntary: Firm Initiated","Letter","Nationwide Distribution.","Z-0874-2013","Class II","KY SilkE Vaginal Moisturizer and Personal Lubricant. The product is packaged in 2.5 oz bottles, which are then packed into a printed carton. Distributed by McNeil-PPC Inc.","Carton: 380040087149Case Code: 008714 V05 Outer case UPC Code: 103800400871460055 Outer case Display UPC Code: 00380041153300 ",,"750,264 units","This product is not cleared for marketing in the US.",1/25/2013,"01/25/2013",3/6/2013,"03/06/2013"
"Devices",64322,"Ongoing","Mc-NEIL-PPC, Inc.","Skillman","NJ","US","Voluntary: Firm Initiated","Letter","Nationwide Distribution.","Z-0873-2013","Class II","KY SENSITIVE TM JELLY Personal Lubricant. The product is packaged into 3 oz tubes, which are then packed into a printed carton. Distributed by McNeil-PPC Inc. ","Tube UPC: 380040085503Case Code(s): 008550 V21, 008550 V00 Outer case UPC Code: 103800400855000215 Outer case UPC Code: 103800400855000000 Outer case Display UPC Code: 00380041153300 ",,"1,185,664 units","This product is not cleared for marketing in the US.",1/25/2013,"01/25/2013",3/6/2013,"03/06/2013"
"Devices",64322,"Ongoing","Mc-NEIL-PPC, Inc.","Skillman","NJ","US","Voluntary: Firm Initiated","Letter","Nationwide Distribution.","Z-0875-2013","Class II","KY TINGLING JELLY Personal Lubricant. The product is packaged into 5 oz tubes with the UPC printed on it. Distributed By: McNeil-PPC Inc.","Tube UPC: 380040088887Case Code(s): 008888 V21, 008888 V00 Outer Case UPC: 103800400888840215, 103800400888840000",,"425,304 units","This product is not cleared for marketing in the US.",1/25/2013,"01/25/2013",3/6/2013,"03/06/2013"
"Biologics",64324,"Terminated","Plasma Biological Services Inc","Memphis","TN","US","Voluntary: Firm Initiated","FAX","California","B-1185-13","Class II","Source Plasma","UQ170193; UQ169364; UQ167981; UQ167387; ",,"4","Blood products, collected from a donor who was previously deferred, were distributed.",12/26/2012,"12/26/2012",5/22/2013,"05/22/2013"
"Drugs",64325,"Ongoing","Lupin Pharmaceuticals Inc.","Baltimore","MD","US","Voluntary: Firm Initiated","Letter","Nationwide","D-264-2013","Class III","Suprax (cefixime for oral suspension) USP, 100 mg/5 mL, 50 mL bottles (when reconstituted), Manufactured for Lupin Pharmaceuticals, Inc. 111 South Calvert Street, Baltimore, MD 21202, Manufactured by Lupin Limited Mumbai 400 058 India, NDC 68180-202-03.","Lot #s: MSA 2021A, MSA 2024A, MSA 2025A, Exp July 2014",".","64,368 bottles","Discoloration; Product may not meet specifications for color description once reconstituted.",1/31/2013,"01/31/2013",4/24/2013,"04/24/2013"
"Devices",64326,"Ongoing","Bacterin International, Inc.","Belgrade","MT","US","Voluntary: Firm Initiated","E-Mail","13 US consignees located in CA, CO, MT, TX, UT, and VA. This represents 4 customers and 9 other individual contacts in USA that received marketing samples. Plus 4 Bacterin representives nationwide received samples. Foreign Consingee","Z-0936-2013","Class II","Bacterin Elutia, Hubless Coated Silicone Surgical Wound Drain 24 Fr Round Hubless, Full-Fluted Coated with Silver Sulfadiazine STERILE, Box of 10 Part #7118. Indicated for use in surgical wound drainage.","005312; 011012; 012111; 012311; 012511; 013011; 019212; 023611; 023811; 024011; 024211; 025912; 033611; 042211",,"15 boxes (10/box) to 4 consignees in US and 81 boxes (10/box) to 1 foreign consignee","A portion of a silicone wound drain was found to be cracked.",1/28/2013,"01/28/2013",3/20/2013,"03/20/2013"
"Devices",64327,"Completed","Biomerieux Inc","Hazelwood","MO","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Distributed only in HI.","Z-1013-2013","Class II","bioMerieux VITEK 2 AST-ST01 Streptococcus Susceptibility Card, REF 410 028. For use with VITEK 2 systems to determine the susceptibility of Streptococcus to antimicrobial agents.","lot number: 540274420",,"4/20-card cartons","The product package did not contain the correct version of the package insert listing the limitations of use and performance requirements. ",2/6/2013,"02/06/2013",4/3/2013,"04/03/2013"
"Devices",64328,"Ongoing","Elekta, Inc.","Atlanta","GA","US","Voluntary: Firm Initiated","Letter","Nationwide Distribution-including the states of AK, CA, FL, NJ, NC, OH, OR, TN, TX, WA, and WI.","Z-0841-2013","Class II","Monaco RTP System. Radiation treatment planning.","Versions 3.20.00 and 3.20.01",".","13","The beam is displayed at the ''gantry'' angle, but the dose is calculated at the ''rotation_start'' angle.",2/11/2013,"02/11/2013",2/27/2013,"02/27/2013"
"Devices",64329,"Ongoing","Medrad Inc","Indianola","PA","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution including USA nationwide.","Z-0870-2013","Class II","MEDRAD Hand Controller Sheath, Catalog number AVA 500 HCS/3010903, for cardiac catheterization procedures. The Sterile Sheath is specifically intended for use in the x-ray angiography environment to cover the Medrad Avanta Sterile Hand Controller to prevent cross contamination between patients.","Catalog number AVA 500 HCS/3010903 - Lot numbers D72211, DA82711, DA93131, D101091, D101681, D110591, D111961, D113341A, D120731, D101641, D82741, D93131, DA101091, DA101691, D110601, D111991, D113351, D120831A, D72251, D83011, D93151, D101101, D101701, D110611, D112061, D113351A, D120741, D72261, DA83021, DA93151, DA101101, DA101721, D110621, D112131, D113461, D120761, D72281, DA83031, DA93221, D101111, D101721, D110631, D112131A, D113461A, D120771, D72291, D83041, D93231, DA101111, D101731, D110661, D112341, D113471, D120831, D72651, DA83121, D93411, D101121, D101741, D110731, D112341A, D113471A, D120861, D72671, D83151, DA93411, DA101121, D101861, D110741, D112351, D113491, DA72681, D83651, D93421, D101131, DA101861, D110751, D112351A, D113501, DA72691, D90021, DA93421, DA101131, D101881, D110871, D112361, D120161, D72751, D90541, D93431, D101171, DA101881, D110881, D112361A, D120161A, D120891, D90561, DA93431, D101301, DA101901, D110901, D112411, D120171, D80221, D90611, D93561, D101311, D101911, D111201, D112411A, D120171A, DA80231, DA90631, D93631, DA101441, DA101931, D111221, D112421, D120181, DA80241, D90821, DA93631, D101441, D101931, D111231, D112421A, D120311, D80281, DA90831, DA100141, D101461, D101951, D111241, D112431, D120311A, D80391, D90981, D100151, DA101461, DA101951, D111261, D112431A, D120321, DA80561, D91031, D100181, D101471, D101971, D111261A, D112441, D120321A, D80631, DA91041, DA100191, DA101481, D102111, D111291, D112441A, D120331, DA80641, DA91061, DA100321, D101481, D102141, D111291A, D112481, D120341, D80871, D91071, D100331, DA101511, DA102141, D111301, D112481A, D120371, D80981, D91181, DA100341, D101511, D102151, D111301A, D112491, D120371A, DA81281, D91191, D100351, D101531, DA102151, D111311, D112501, D120381, DA81421, D91281, DA100461, DA101531, D102351, D111311A, D112621, D120381A, D81471, D91331, D100561, D101541, DA102351, D111321, D112621A, D120391, D81541, D91351, D100671, D101551, D102811, D111321A, D112631, D120451, DA81821, D91381, DA100671, DA101551, D102821,",".","832,175","Bayer is initiating this recall because in certain packages within the affected lots, the seal between the white polyethylene and the clear plastic may be missing on the Hand Controller Sheath package, resulting in a potential breach of the sterility of this accessory.",11/5/2012,"11/05/2012",2/27/2013,"02/27/2013"
"Devices",64330,"Ongoing","Extremity Medical LLC","Parsippany","NJ","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution-USA including the states of Florida, Pennsylvania, New Hampshire, Oklahoma, California, Maryland, Arizona, Ohio, North Carolina, Texas, Virginia, Illinois, New York and Tennessee, and the countries of Australia, Belgium, Israel, Netherlands and United Kingdom.","Z-0952-2013","Class II","Extremity Medical - Disposable Orthopedic Surgical Instrument - 1.6 mm Guidewire - Reference Number 101-00006 - Non-Sterile. Contained in Extremity Medical Surgical Kits including CompressX, Hallu.X, IO Fix and XMCP. Used in the selection of screw size when used with appropriate depth gauge.","Catalog Number 101-00006; Lot Number 00921538.",".","238 units","The 1.6 mm Guidewire is undersized up to 2 mm in length. When used with the depth gauge, the measurement reading will not correspond with the desired screw length. The selected screw size based on the depth gauge reading will be about 2 mm longer than intended.",1/10/2013,"01/10/2013",3/27/2013,"03/27/2013"
"Food",64331,"Ongoing","Specialty Commodities, Inc.","Fargo","ND","US","Voluntary: Firm Initiated","Telephone","CA, IL, MO, ND, NJ, OK, PA, WI","F-1028-2013","Class I","Egyptian Parsley Flakes, Weight: 10kg Net.","Manufacturer's code: Batch No. 127, Lot#.: 214 Specialty Commodities' Lot numbers: SD28173, RE49421, SCS321167. ",,"780 containers","Specialty Commodities was notified by a customer that they had found Parsley Flakes to be positive for Salmonella.",2/8/2013,"02/08/2013",3/6/2013,"03/06/2013"
"Devices",64332,"Ongoing","Beckman Coulter Inc.","Brea","CA","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Worldwide distribution: USA (nationwide) and countries of: Aurstria, Belgium, Bulgaria, Canada, Croatia, Czech Republic, Denmark, Djibouti, Finland, France, Germany, Greece, Hungary, Ireland, Italy, Latvia, Lithuania, Netherlands, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, Switzerland, Turkey and United Kingdom.","Z-1033-2013","Class II","Access 2 Immunoassay System; P/N 107405S 2/12 The Access Immunoassay Systems are in vitro diagnostic devices used for the quantitative, semi-quantitative or qualitative determination of various analyte concentrations found in human body fluids.","Part # 81600N, 386220, A12900, A69186; All Serial Numbers",".","3500 units","Beckman Coulter is initiating a recall due to a defective newly released aluminum incubator belt pulley that may rub against the light shield, which causes the formation of debris. Debris that is caused by the incubator belt pulley rubbing against the light shield can fall into the reaction vessels (RVs) and present a risk of erroneous test results.",2/12/2013,"02/12/2013",4/10/2013,"04/10/2013"
"Devices",64332,"Ongoing","Beckman Coulter Inc.","Brea","CA","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Worldwide distribution: USA (nationwide) and countries of: Aurstria, Belgium, Bulgaria, Canada, Croatia, Czech Republic, Denmark, Djibouti, Finland, France, Germany, Greece, Hungary, Ireland, Italy, Latvia, Lithuania, Netherlands, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, Switzerland, Turkey and United Kingdom.","Z-1034-2013","Class II","Synchron LXi 725 Clinical System; P/N 107405S Product Usage: The Access Immunoassay Systems are in vitro diagnostic devices used for the quantitative, semi-quantitative or qualitative determination of various analyte concentrations found in human body fluids. ","Part # A15642; All Serial Numbers",".","83 units","Beckman Coulter is initiating a recall due to a defective newly released aluminum incubator belt pulley that may rub against the light shield, which causes the formation of debris. Debris that is caused by the incubator belt pulley rubbing against the light shield can fall into the reaction vessels (RVs) and present a risk of erroneous test results.",2/12/2013,"02/12/2013",4/10/2013,"04/10/2013"
"Devices",64332,"Ongoing","Beckman Coulter Inc.","Brea","CA","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Worldwide distribution: USA (nationwide) and countries of: Aurstria, Belgium, Bulgaria, Canada, Croatia, Czech Republic, Denmark, Djibouti, Finland, France, Germany, Greece, Hungary, Ireland, Italy, Latvia, Lithuania, Netherlands, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, Switzerland, Turkey and United Kingdom.","Z-1035-2013","Class II","UniCel DxC 600i Synchron Access Clinical System; P/N 107405S Product Usage: The Access Immunoassay Systems are in vitro diagnostic devices used for the quantitative, semi-quantitative or qualitative determination of various analyte concentrations found in human body fluids.","Part # A25640, A25638, A25656, A25637; All Serial Numbers",".","956 units","Beckman Coulter is initiating a recall due to a defective newly released aluminum incubator belt pulley that may rub against the light shield, which causes the formation of debris. Debris that is caused by the incubator belt pulley rubbing against the light shield can fall into the reaction vessels (RVs) and present a risk of erroneous test results.",2/12/2013,"02/12/2013",4/10/2013,"04/10/2013"
"Devices",64332,"Ongoing","Beckman Coulter Inc.","Brea","CA","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Worldwide distribution: USA (nationwide) and countries of: Aurstria, Belgium, Bulgaria, Canada, Croatia, Czech Republic, Denmark, Djibouti, Finland, France, Germany, Greece, Hungary, Ireland, Italy, Latvia, Lithuania, Netherlands, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, Switzerland, Turkey and United Kingdom.","Z-1032-2013","Class II","Access Immunoassay System; P/N 107405S Product Usage: The Access Immunoassay Systems are in vitro diagnostic devices used for the quantitative, semi-quantitative or qualitative determination of various analyte concentrations found in human body fluids.","Part # 81600; All Serial Numbers",".","579 units","Beckman Coulter is initiating a recall due to a defective newly released aluminum incubator belt pulley that may rub against the light shield, which causes the formation of debris. Debris that is caused by the incubator belt pulley rubbing against the light shield can fall into the reaction vessels (RVs) and present a risk of erroneous test results.",2/12/2013,"02/12/2013",4/10/2013,"04/10/2013"
"Biologics",64333,"Terminated","Michigan Blood","Grand Rapids","MI","US","Voluntary: Firm Initiated","FAX","Michigan","B-1186-13","Class II","Platelets Pheresis Leukocytes Reduced","W120612021337 Part A; W120612021337 Part B ",,"2","Blood products, which were labeled as leukoreduced, but were not tested to verify the White Blood Cell count, were distributed.",12/27/2012,"12/27/2012",5/22/2013,"05/22/2013"
"Biologics",64334,"Terminated","Memorial Blood Centers","Saint Paul","MN","US","Voluntary: Firm Initiated","Letter","Minnesota","B-1187-13","Class II","Platelets Pheresis Leukocytes Reduced","W051512134136; ",,"1","Blood product, which was collected from a donor in which donor suitability was not adequately determined, was distributed.",1/17/2013,"01/17/2013",5/22/2013,"05/22/2013"
"Biologics",64335,"Terminated","Memorial Blood Centers","Saint Paul","MN","US","Voluntary: Firm Initiated","Letter","Minnesota","B-1197-13","Class III","Red Blood Cells (Apheresis) Leukocytes Reduced","W051512077416; W051512077426; W051512077431; ",,"3","Blood products, labeled with incorrect volume, were distributed.",12/18/2012,"12/18/2012",5/22/2013,"05/22/2013"
"Biologics",64336,"Terminated","Memorial Blood Centers","Saint Paul","MN","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Switzerland; Minnesota","B-1188-13","Class II","Red Blood Cells Leukocytes Reduced Irradiated","1413206; ",,"1","Blood products, collected from a donor in whom donor suitability was not adequately determined, were distributed.",11/16/2012,"11/16/2012",5/22/2013,"05/22/2013"
"Biologics",64336,"Terminated","Memorial Blood Centers","Saint Paul","MN","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Switzerland; Minnesota","B-1189-13","Class III","Blood and Blood Products for Reprocessing","1413206; ",,"1","Blood products, collected from a donor in whom donor suitability was not adequately determined, were distributed.",11/16/2012,"11/16/2012",5/22/2013,"05/22/2013"
"Food",64337,"Ongoing","Zip International Group","Edison","NJ","US","Voluntary: Firm Initiated","Letter","NY","F-1007-2013","Class I","Bream Dry Salted Fish Net Wt.: about 14.2 ozImported by Zip International Group LLC Product of Russia","835856001228; sell by 03/27/2013",,"5 boxes (77 lbs)","NYSDAM sampling and analysis has revealed that Dry Salted Fish is uneviscerated.",2/7/2013,"02/07/2013",3/6/2013,"03/06/2013"
"Drugs",64338,"Ongoing","Glenmark Generics Inc., USA","Mahwah","NJ","US","Voluntary: Firm Initiated","Letter","Nationwide","D-182-2013","Class III","Montelukast Sodium Tablets, 10 mg (base), packaged in a) 30-count tablets per bottle (NDC 68462-392-30) and b) 90-count tablets per bottle (NDC 68462-392-90), Rx only, Manufactured by: Glenmark Generics Ltd., Colvale-Bardez, Goa 403513, India; Manufactured for: Glenmark Generics Inc., USA, Mahwah, NJ 07430. ","02122956, 02123226, 02123269, 02123480, 02123481,02122933, 02122955, 02123062, 02123075, 02123085, 02123114, 02123115, 02123124, 02123125, 02123189, 02123199, 02123205, 02123219, 02123253, 02123270, 02123289, 02123295, 02123320, 02123333, 02123343, 02123349, 02123411, 02123421, 02123431, Exp 09/14 and 10/14 ",,"591,972 bottles","Chemical Contamination: The recall has been initiated based on multiple complaints received from pharmacists and consumers reporting that they detected an off-odor, described as moldy, musty or fishy in nature which has been identified as trace levels of Tribromoanisole (TBA) and Trichloroanisole (TCA).",2/13/2013,"02/13/2013",3/13/2013,"03/13/2013"
"Drugs",64339,"Ongoing","Ferring Pharmaceuticals Inc","Parsippany","NJ","US","Voluntary: Firm Initiated","Letter","Nationwide","D-240-2013","Class III","TEV-TROPIN (somatropin (rDNA origin) for injection) 5 mg (15 IU). Prescription Only. Distributed By: TEVA Biologics & Specialty Products Division of Teva Pharmaceuticals USA, Sellersville, PA 18960 Manufactured in Israel.","LOT #201131320087 Exp 09/15",".","126 injectors","Labeling: Label Mix-up: Units of Lot 201131320087 are packaged in cartons labelled for Needle-Free Head B, but contaiin Needle-Free Head A",2/1/2013,"02/01/2013",4/10/2013,"04/10/2013"
"Food",64341,"Terminated","LYFE Kitchen Retail, Inc.","Richmond","BC","CA","Voluntary: Firm Initiated","Email","CA and NV","F-1062-2013","Class II","LYFE Kitchen, Sweet Corn Chowder with Cashew Cream, Yukon Gold Potatoes and Bell Peppers;28 oz. 680 gr, Keep Refrigerated. UPC 855764003527 Del Monaco Specialty Products, Morgan Hill, CA","Expiration date 3/25/13Orange Carrot Ginger Sleeve UPC 8557640035703, product code 00350; ",,"111 cases (each case has 12x 28 oz container).","Costco notified firm that some containers of their LYFE Kitchen Sweet Corn Chowder were packaged in a sleeve labeled Orange Carrot Ginger Soup. Individual boxes of the corn chowder are properly labeled and product identity is visible to the consumer.",2/11/2013,"02/11/2013",3/20/2013,"03/20/2013"
"Devices",64342,"Ongoing","Smith & Nephew Inc","Memphis","TN","US","Voluntary: Firm Initiated","E-Mail","Worldwide Distribution - USA including NM, TN, TX, NC, CA, MI, KY, MA, NJ, OH, and HI. Internationally to Canada, United Arab Emirates, Mexico, Argentina, Japan, and Chile.","Z-0943-2013","Class II","INTERNAL HEX RECON SCREW, TI-6AL-4V, REF 7162380, TRIGEN (R) INTERNAL HEX CAPTURED RECON SCREW, QTY: (1), 6.4 MM, 80 MM, TITANIUM, Smith & Nephew, Inc. Orthopedic. Bone screw for intramedullary rod fixation.","Batch Number 12KM01206",,"69 units","75 mm screws were packaged and labeled using an 80 mm screw outer box and label, while 80 mm screws were packaged and labeled using a 75 mm screw outer box and label.",2/7/2013,"02/07/2013",3/20/2013,"03/20/2013"
"Devices",64342,"Ongoing","Smith & Nephew Inc","Memphis","TN","US","Voluntary: Firm Initiated","E-Mail","Worldwide Distribution - USA including NM, TN, TX, NC, CA, MI, KY, MA, NJ, OH, and HI. Internationally to Canada, United Arab Emirates, Mexico, Argentina, Japan, and Chile.","Z-0944-2013","Class II","INTERNAL HEX RECON SCREW, TI-6AL-4V, REF 7162375, TRIGEN (R) INTERNAL HEX CAPTURED RECON SCREW, QTY: (1), 6.4 MM, 75 MM, TITANIUM, Smith & Nephew, Inc. Orthopedic. Bone screw for intramedullary rod fixation.","Batch Number 12JM17051",,"90 units","75 mm screws were packaged and labeled using an 80 mm screw outer box and label, while 80 mm screws were packaged and labeled using a 75 mm screw outer box and label.",2/7/2013,"02/07/2013",3/20/2013,"03/20/2013"
"Devices",64343,"Ongoing","Ethicon Endo-Surgery Inc","Cincinnati","OH","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution -- USA, including the states of AK, AL, AR, AZ, CA, CO, CT, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV, & WY; and, the countries of ARGENTINA, AUSTRALIA, AUSTRIA, BAHRAIN, BELGIUM, BRAZIL, CANADA, CHILE, CHINA, COLOMBIA, COSTA RICA, CZECH REPUBLIC, DOMINICAN REPUBLIC, ECUADOR, EGYPT, GERMANY, GREECE, GUATEMALA, HONG KONG, HUNGARY, INDIA, INDONESIA, ISRAEL, ITALY, JAMAICA, JAPAN, JORDAN, KUWAIT, LIBYAN ARAB JAMAHIRIYA, MALAYSIA, MEXICO, NETHERLANDS ANTILLES, NICARAGUA, NICOSIA, PAKISTAN, PANAMA, PERU, PHILIPPINES, POLAND, PORTUGAL, PROVINCE OF CHINA, PUERTO RICO, REPUBLIC OF KOREA, RUSSIAN FEDERATION, SAUDI ARABIA, SINGAPORE, SLOVENIA, SOUTH AFRICA, SPAIN, SWITZERLAND, THAILAND, TRINIDAD AND TOBAGO, TURKEY, UNITED ARAB EMIRATES, UNITED KINGDOM, URUGUAY, VENEZUELA &, YEMEN.","Z-0918-2013","Class II","PROXIMATE Skin Staple Extractor,ETHICON ENDO-SURGERY, LLC Guaynabo, Puerto Rico 00969 USA Assembled in Mexico. For routine skin closure in a wide variety of surgical procedures. ","Expiration dates: September 2012 - August 2017",,"5,894,975 pieces","Ethicon Endo-Surgery initiated a voluntary recall for all PSX Proximate Skin Staple Extractors because the possibility exists that damage to the packaging may have compromised the sterility of the device.",10/4/2012,"10/04/2012",3/13/2013,"03/13/2013"
"Devices",64344,"Ongoing","Sorin C.R.M., srl","Saluggia, VC",,"IT","Voluntary: Firm Initiated","Letter","Worldlwide Distribution - USA (Nationwide) and worldwide to Argentina, Australia, Austria, Belgium, Brazil, Canada, Cuba, Czech Republic, Denmark, Egypt, France, Germany, Greece, Hong Kong, India, Iran, Ireland, Israel, Italy, Japan, Kuwait, Lebanon, Morocco, The Netherlands, Portugal, Russia, Saudi Arabia, Slovenia, Spain, Sweden, Switzerland, Tunisia, Ukraine, Uruguay and the United Kingdom.","Z-0928-2013","Class II","Isoline Implantable Defibrillation Lead, Model Isoline 2CR5, 2CR6 and 2CT6. These lead models are indicated for ventricular antitachycardia pacing and ventricular defibrillation for automated treatment of life threatening arrhythmias","Models: 2CR5, 2CR6 and 2CT6, Distributed From 03/19/08 To 01/21/13 ",,"1376 Isoline leads","Isoline defibrillation leads distributed may have internal insulation breach.",1/28/2013,"01/28/2013",3/20/2013,"03/20/2013"
"Food",64345,"Ongoing","Qtrade Teas And Herb","Cerritos","CA","US","Voluntary: Firm Initiated","Telephone","Nationwide in the US:CA, NY, PA, NJ, MO, MA, OH, RI, CO, NC. Worldwide in: Canada","F-1026-2013","Class I","Organic Lemon Grass Tea Bag Cut (TBC), Item#410. Packing Size: 25 kgs net double craft paper bags and double polyethylene bags each inner liner and repacked product packed in corrugated cartons with polyethylene inner liner. Organic Lemon Grass Tea Bag Cut (TBC) bulk sold in original, repacked cases, and as component of blended bulk tea products.","Lot#108",,"6,303.78 lbs","QTrade Teas & Herbs is recalling Organic Lemon Grass Tea Bag Cut (TBC) because it has the potential to be contaminated with Salmonella.",2/8/2013,"02/08/2013",3/6/2013,"03/06/2013"
"Food",64347,"Ongoing","Whole Foods Market","Austin","TX","US","Voluntary: Firm Initiated","Letter","Nationwide domestically and to Canada.","F-1006-2013","Class III","Whole Foods Market Panettone Chocolate - 26.4 oz, 12 per case. ","Lot codes: O 262, O 263 and O 264.",,"1,035 cases (12,420 retail units)","The reason for the recall was that a small portion of the Whole Foods Market Cranberry Panettone was mispackaged in Whole Foods Market Panettone Chocolate boxes. Allergens are declared on both labels, but the only difference is that soy is in the 'may contains' statement on Whole Foods Market Cranberry Panettone box and on the Whole Foods Market Chocolate Panettone box, soy is declared in the 'contains' box.",11/8/2012,"11/08/2012",3/6/2013,"03/06/2013"
"Devices",64348,"Completed","Innominata Dba Genbio","San Diego","CA","US","Voluntary: Firm Initiated","Letter","Nationwide distribution: CA, IL, MA, MD, ME, NC, ND, NJ, NY, OR, VA and WI.","Z-0927-2013","Class II","ANTI-BORRELIA (LYME) MICROPLATE EIA Kit, Catalog # 32507 Kit Lot Number 120960. Package Insert Supplement: Calibrator-1206 U/mL, Positive Control-228 - 532 U/mL, and Negative Control-<120 U/mL; Manufactured by Innominata dba GenBio for Bio-Rad. The kit is used as an aid in diagnosis of Lyme disease.","Lot #120960 (121003. 121058,121002), ; Exp./Cad/Verw/bis: 2013-09; Catalog#802-3011; 25271, 25272, 25273; Label P/N 522-0040, 522-0037, 522-0011",,"195","Multiple incidents of low-reacting assay plates.",2/11/2013,"02/11/2013",3/20/2013,"03/20/2013"
"Food",64349,"Ongoing","Nestle USA","Solon","OH","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Product was shipped to the following states: AL, AR, AZ, CA, CO, CT, DE, FL, GA, IA, IL, IN, KS, KY, LA, MA, MD, ME, MI, MI, MN, MO, MS, NC, NE, NJ, NM, NV, NY, OH, OK, OR, PA, SC, TN, TX, UT, VA, VT, WA, WI & WY.","F-0998-2013","Class II","Lean Cuisine Culinary Collection Mushroom Mezzaluna Ravioli ravioli filled with portobello & button mushrooms, romano & ricotta cheeses in a creamy marsala wine sauce with spinach & red peppers no preservatives, NET WT 8 5/8 oz (244g) 0 13800 58358 1 DISTRIBUTED BY: NESTLE' USA, INC., SOLON, OH 44139","Lot 2311587812 Best Before Dec2013 and Lot 2312587812 Best Before Dec2013, UPC Code 13800-58358",".","41,818 cs/12/8 5/8 oz packages","The firm received complaints of small fragments of glass that were found inside the ravioli portion of the entre. ",2/8/2013,"02/08/2013",2/27/2013,"02/27/2013"
"Biologics",64350,"Terminated","American Red Cross Blood Services","Omaha","NE","US","Voluntary: Firm Initiated","Telephone","Nebraska","B-1190-13","Class II","Plasma Frozen within 24 hours (FP24)","009KE30955; ",,"1","Blood product, collected from a donor in whom donor suitability was not adequately determined, was distributed.",1/6/2013,"01/06/2013",5/22/2013,"05/22/2013"
"Biologics",64352,"Terminated","Florida's Blood Centers, Inc.","Orlando","FL","US","Voluntary: Firm Initiated","Letter","Florida","B-1192-13","Class II","Plasma Frozen","W038112201491; ",,"1","Blood products, collected from a donor who was previously deferred, were distributed.",11/7/2012,"11/07/2012",5/22/2013,"05/22/2013"
"Biologics",64352,"Terminated","Florida's Blood Centers, Inc.","Orlando","FL","US","Voluntary: Firm Initiated","Letter","Florida","B-1191-13","Class II","Red Blood Cells Leukocytes Reduced","W038112201491; ",,"1","Blood products, collected from a donor who was previously deferred, were distributed.",11/7/2012,"11/07/2012",5/22/2013,"05/22/2013"
"Food",64353,"Ongoing","Kellogg Company","Battle Creek","MI","US","Voluntary: Firm Initiated","Letter","Distribution centers in GA, CA, PA, IL with further distribution nationwide. No Canadian or outside USA distribution.","F-1134-2013","Class II","Kellogg's Special K Red Berries, Crunchy Rice & Wheat Flakes with Strawberries 11.2oz; 37 oz; 22.4 ounce Twin Pack ","1. 11.2 oz. pkg, UPC Code 38000 59923, Better if Used by DEC 02 2013 KNC 105 00:13 through DEC 02 2013 KNC 105 02:30 2. 37 oz Club Pkg, UPC Code 38000 20940 , Better if Used by NOV 30 2013 KNB 107 17:31 to NOV 30 2013 KNB 107 20:05 3. 22.4 oz Twin PackUPC Code 38000 78356 Better if Used by: NOV 30 2013 KNA 105 07:00 to NOV 30 2013 KNA 105 08:51 NOV 30 2013 KNB 105 15:00 to NOV 30 2013 KNB 105 17:05 ",,"26,880 all sizes","A limited amount of Kellogg's Special K, Red Berries is being recalled due to possible glass fragments present in the product, likely from a single batch of one ingredient.",2/15/2013,"02/15/2013",3/20/2013,"03/20/2013"
"Devices",64354,"Ongoing","Biomet, Inc.","Warsaw","IN","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Worldwide Distribution - No USA distribution -Internationally to Canada, Japan, and Chile","Z-0925-2013","Class II","REF S313152 Straight Acetabular Inserter Handle Ringlocnon-sterile Orthopedic manual surgical instrument","Catalog Number 5313152Lot 153880,153930, 415500, 648010",,"58","The Straight Ringloc Button Latch Inserter Handle may have been manufactured at the higher end of the tolerance causing interference with the Ringloc cup. The inserter handle may lock onto the cup during impaction. If alternative inserters are not available this could cause a surgical delay greater than 30 minutes.",2/5/2013,"02/05/2013",3/20/2013,"03/20/2013"
"Biologics",64355,"Terminated","Rochester Eye and Human Parts Bank, Inc.","Rochester","NY","US","Voluntary: Firm Initiated","Letter","New York","B-2415-13","Class II","Cornea","120442OSCN",,"1 cornea","Human Cornea, not tested to adequately and appropriately reduce the risk of transmission of relevant communicable disease agents or diseases, was distributed. ",12/19/2012,"12/19/2012",9/25/2013,"09/25/2013"
"Biologics",64356,"Terminated","Sight Society of Northeastern New York Lions Eye Bank@Albany","Albany","NY","US","Voluntary: Firm Initiated","Letter","New York","B-2340-13","Class II","Human Cornea for Transplant Preserved in Optisol GS --- Single Patient Use --- Lions Eye Bank at Albany 518-489-7606 ","NY1301009 R1 (Right) and NY1301009 L1 (Left); ",,"2 corneas (1 left, 1 right)","Human Corneas, not tested to adequately and appropriately reduce the risk of transmission of relevant communicable disease agents or diseases, were distributed.",1/18/2013,"01/18/2013",11/6/2013,"11/06/2013"
"Devices",64357,"Ongoing","Integra LifeSciences Corp.","Plainsboro","NJ","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution - USA Nationwide including Canada.","Z-0886-2013","Class II","Integra(R) Jarit(R) Monopolar Cable (Catalogue No. 600-290) Product Usage: Endoscopic Instruments - For use by, or as directed by, a surgeon in endoscopic surgery. For use when a rigid endoscopic instrument for grasping and/or dissecting if soft tissue is determined to be appropriate by the surgeon. Monopolar Cable - Monopolar electrosurgical current can be used for coagulation and/or cutting as determined necessary and appropriate by the surgeon.","All lots distributed since 2004",,"22,500","Integra has received complaint reports related to the electrical safety of the monopolar electrosurgical cables. ",2/12/2013,"02/12/2013",3/6/2013,"03/06/2013"
"Drugs",64358,"Ongoing","Watson Laboratories Inc","Corona","CA","US","Voluntary: Firm Initiated","Letter","Nationwide","D-205-2013","Class II","ZARAH Drospirenone/ Ethinyl Estradiol Tablets, 3.0 mg/0.03 mg, Rx only, 3 tablet dispensers, 28 tablets each, Manuf. by: Watson Laboratories, Inc., Corona, CA 92880. USA; Distributed by: Watson Pharma, Inc., Corona, CA 92880 USA. NDC 52544-981-31 Carton; NDC 52544-981-28 ","Lot #s: 401536AA/401536A; 401537AA/401537/A; 401538AA/401538/A; 406985AA/406985A; 432058AA/432058A; 512685AA/512685A",".","136,720 cartons","Failed Tablet/Capsule Specification; tablet breakage while pushing through the blister pack (dispenser) .",2/13/2013,"02/13/2013",3/27/2013,"03/27/2013"
"Food",64359,"Ongoing","Teatulia","Denver","CO","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Shipped to one distributor who sold it to 15 restaurants all in Colorado.","F-1025-2013","Class I","Sold as In-House brand iced tea: Garbanzo Mediterranean Grill Organic Lemongrass Ginger Green Tea, 3 oz. packages ","Lot code #2234",,"14 Pounds of 3 Ounce packages, 32 packs per case","Tea received from bulk supplier may be contaminated with Salmonella. ",2/14/2013,"02/14/2013",3/6/2013,"03/06/2013"
"Food",64360,"Ongoing","Js Pelmeni Ok, Inc.","Brooklyn","NY","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","New York, Massachusetts, Pennsylvania, New Jersey, and Illinois.","F-1030-2013","Class I","Potato & Mushroom Dumplings, Net Weight 1 lb. (16 oz.), KEEP FROZEN, UPC 6 54368 10039 3 --- JS Pelmeni OK - EST # A615133 - 667 Coney Island Ave., Brooklyn, NY 11218 - (718) 469-1490","UPC 6 54368 10039 3 and no other coding",,,"The product contains undeclared milk and soy based on observations found during a joint inspection by the FDA and New York State Department of Agriculture & Markets. ",2/13/2013,"02/13/2013",3/6/2013,"03/06/2013"
"Food",64360,"Ongoing","Js Pelmeni Ok, Inc.","Brooklyn","NY","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","New York, Massachusetts, Pennsylvania, New Jersey, and Illinois.","F-1029-2013","Class I","Potato Dumplings, Net Weight 2 lb. (32 oz.), KEEP FROZEN, UPC 6 54368 10038 6, EST # A613069 --- JS Pelmeni OK - 667 Coney Island Ave., Brooklyn, NY 11218 - (718) 469-1490","UPC 6 54368 10038 6 and no other coding",,,"The product contains undeclared milk and soy based on observations found during a joint inspection by the FDA and New York State Department of Agriculture & Markets. ",2/13/2013,"02/13/2013",3/6/2013,"03/06/2013"
"Food",64361,"Ongoing","Ethnic International Holding Inc","Cranbury","NJ","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Connecticut, Georgia, Massachussets, Maryland, New Jersey, New York, Tennessee and Virginia.","F-1067-2013","Class II","ROSEHIP DRINK MIX. Yoruk Prens Tarcin Kusburnu Net 400 g. USA Distributor: Ethnic Int. Holding Inc. 4 Corporate Drive, Cranbury, NJ 08512. Tel. 609-395-8513. Picture of flower on label.","Expiration date 1/04/2013.",,,"Yoruk Prens brand drink mix flavored Apple, Orange, Pomegranate, Cinnamon and Rosehip. We were informed that these products include some colorants, which are not allowed to use in the USA as per a New York State Department of Agriculture and Markets sample analysis.",12/27/2012,"12/27/2012",3/20/2013,"03/20/2013"
"Food",64361,"Ongoing","Ethnic International Holding Inc","Cranbury","NJ","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Connecticut, Georgia, Massachussets, Maryland, New Jersey, New York, Tennessee and Virginia.","F-1063-2013","Class II","APPLE DRINK MIX. Yoruk Prens Elma Net 400 g. USA Distributor: Ethnic Int. Holding Inc. 4 Corporate Drive, Cranbury, NJ 08512. Tel. 609-395-8513. Picture of green apple on label.","Expiration date 1/04/2013.",,"Total of 166 Cases (20 containers per case) for all 4 flavors","Yoruk Prens brand drink mix flavored Apple, Orange, Pomegranate, Cinnamon and Rosehip. We were informed that these products include some colorants, which are not allowed to use in the USA as per a New York State Department of Agriculture and Markets sample analysis.",12/27/2012,"12/27/2012",3/20/2013,"03/20/2013"
"Food",64361,"Ongoing","Ethnic International Holding Inc","Cranbury","NJ","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Connecticut, Georgia, Massachussets, Maryland, New Jersey, New York, Tennessee and Virginia.","F-1065-2013","Class II","POMEGRANATE DRINK MIX. Yoruk Prens Nar Net 400 g. USA Distributor: Ethnic Int. Holding Inc. 4 Corporate Drive, Cranbury, NJ 08512. Tel. 609-395-8513. Picture of pomegranate on label.","Expiration date 1/04/2013.",,"166 total cases all 4 flavors (20 units per case)","Yoruk Prens brand drink mix flavored Apple, Orange, Pomegranate, Cinnamon and Rosehip. We were informed that these products include some colorants, which are not allowed to use in the USA as per a New York State Department of Agriculture and Markets sample analysis.",12/27/2012,"12/27/2012",3/20/2013,"03/20/2013"
"Food",64361,"Ongoing","Ethnic International Holding Inc","Cranbury","NJ","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Connecticut, Georgia, Massachussets, Maryland, New Jersey, New York, Tennessee and Virginia.","F-1066-2013","Class II","CINNAMON DRINK MIX. Yoruk Prens Tarcin Net 400 g. USA Distributor: Ethnic Int. Holding Inc. 4 Corporate Drive, Cranbury, NJ 08512. Tel. 609-395-8513. Picture of cinnamon sticks on label.","Expiration date 1/04/2013.",,"166 total cases (all 4 flavors) (20 units per case)","Yoruk Prens brand drink mix flavored Apple, Orange, Pomegranate, Cinnamon and Rosehip. We were informed that these products include some colorants, which are not allowed to use in the USA as per a New York State Department of Agriculture and Markets sample analysis.",12/27/2012,"12/27/2012",3/20/2013,"03/20/2013"
"Food",64361,"Ongoing","Ethnic International Holding Inc","Cranbury","NJ","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Connecticut, Georgia, Massachussets, Maryland, New Jersey, New York, Tennessee and Virginia.","F-1064-2013","Class II","ORANGE DRINK MIX. Yoruk Prens Portalcal Net 400 g. USA Distributor: Ethnic Int. Holding Inc. 4 Corporate Drive, Cranbury, NJ 08512. Tel. 609-395-8513. Picture of orange on label.","Expiration date 1/04/2013.",,"166 total cases (20 units per case)- all 4 flavors","Yoruk Prens brand drink mix flavored Apple, Orange, Pomegranate, Cinnamon and Rosehip. We were informed that these products include some colorants, which are not allowed to use in the USA as per a New York State Department of Agriculture and Markets sample analysis.",12/27/2012,"12/27/2012",3/20/2013,"03/20/2013"
"Biologics",64362,"Terminated","Biomat USA, Inc","Houston","TX","US","Voluntary: Firm Initiated","FAX","Spain","B-1193-13","Class II","Source Plasma","0050349533; 0050350236; ",,"2","Blood products, collected from a donor whose scheduled physical examination was incomplete, were distributed.",12/7/2012,"12/07/2012",5/22/2013,"05/22/2013"
"Biologics",64363,"Terminated","University Of Miami Miller School of Medicine Tissue Bank","Miami","FL","US","Voluntary: Firm Initiated","FAX","Florida","B-1133-13","Class III","Bone","UBO009160011810",,"1","HCT/P allografts, mislabeled with an incorrect expiration date, were distributed. ",1/25/2013,"01/25/2013",4/3/2013,"04/03/2013"
"Biologics",64364,"Terminated","University Of Miami Miller School of Medicine Tissue Bank","Miami","FL","US","Voluntary: Firm Initiated","Telephone","California","B-1131-13","Class III","Bone","UBO008704012410; UBO008704012510; UBO008704012610; UBO008704012710; UBO008704012810; UBO008704012910; UBO008704013010; UBO008704013110; UBO008704013210; UBO008704013310; UBO008704013510; UBO008704013610; UBO008704013710; UBO008704013810; UBO008704013910; UBO008704014110; UBO008704014210; UBO008704014310; UBO008704014410; UBO008704014510; UBO008704014710; UBO008704014810; UBO008704014910; ",,"23","HCT/P allografts, mislabeled with an incorrect expiration date, were distributed. ",4/6/2010,"04/06/2010",4/3/2013,"04/03/2013"
"Food",64365,"Ongoing","Associated Milk Producers, Inc","Dawson","MN","US","Voluntary: Firm Initiated","Letter","One distributor in WI","F-1027-2013","Class I","GFS Lemon Pulling, Net Wt. 113 oz (7 lb 1 oz) 3.20 kg UPC 93901-10676. Distributed by Gordon Food Service, Grand Rapids, MI 49548.","Lot # 3T12354C printed on the end of can",,"447 cases (6 cans per case)","Undeclared Milk Allergen. GFS labeled Lemon Pudding may contain vanilla pudding which contains milk. The Lemon Pudding label does not list milk.",2/13/2013,"02/13/2013",3/6/2013,"03/06/2013"
"Food",64366,"Ongoing","Muffin Mam Inc (The)","Simpsonville","SC","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","GA, NC, SC, PA, TN, VA and WV.","F-1024-2013","Class I","The Muffin Mam, Inc 24oz Strawberry Crme Cake, UPC 7-60366-00986-3","All Lot Codes",,"301,024 Units","Undeclared Allergen: Eggs.",2/12/2013,"02/12/2013",3/6/2013,"03/06/2013"
"Devices",64367,"Ongoing","Linvatec Corp. dba ConMed Linvatec","Largo","FL","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Worldwide Distribution - USA (nationwide) including the states of: CA, FL, GA, IL, KS, MA, MD, MO, NE, NY, and TX and the countries of: Canada, Germany, Romania, Spain, Palestine, South Africa, France, Sweden and Singapore","Z-0916-2013","Class III","D3000 Advantage Drive System, 115v Product Usage: The Advantage Drive Systems function as a powered instrument system consisting of handpieces and accessories to perform cutting of soft tissue and bone","Model #D3000",,"31 units","The Membrane Switch Panel (referred to as ''front panel'' of the component part number A34-003-207 is used on both the D3000 and D3000I Advantage Drive System, contained the incorrect symbology per third edition IEC60606-01 Medical Electrical Equipment: General requirements for basic safety and essential performance.",1/24/2013,"01/24/2013",3/13/2013,"03/13/2013"
"Devices",64367,"Ongoing","Linvatec Corp. dba ConMed Linvatec","Largo","FL","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Worldwide Distribution - USA (nationwide) including the states of: CA, FL, GA, IL, KS, MA, MD, MO, NE, NY, and TX and the countries of: Canada, Germany, Romania, Spain, Palestine, South Africa, France, Sweden and Singapore","Z-0917-2013","Class III","D3000I Advantage Drive System, 230v Product Usage: The Advantage Drive Systems function as a powered instrument system consisting of handpieces and accessories to perform cutting of soft tissue and bone ","Model #D3000I",,"23 units ","The Membrane Switch Panel (referred to as ''front panel'' of the component part number A34-003-207 is used on both the D3000 and D3000I Advantage Drive System, contained the incorrect symbology per third edition IEC60606-01 Medical Electrical Equipment: General requirements for basic safety and essential performance.",1/24/2013,"01/24/2013",3/13/2013,"03/13/2013"
"Food",64368,"Ongoing","Dakota Specialty Milling, Inc","Fargo","ND","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","AZ, AR, CA, GA, HI, IL, IN, KS, MA, MI, MN, MO, NY, ND, OH, PA, TN, TX, VA, WA, WI.","F-1107-2013","Class II","42207, FIBER PLUS BLEND POLY FREE ( ENRICHED WHEAT FLOUR RIBOFLAVIN, REDUCED IRON, THIAMINE MONONITRATE, NIACIN, FOLIC ACID, OAT BRAN, OAT FIBER, INULIN), DAKOTA SPECIALTY MILLING, INC., FARGO, ND , 19 NET WT. 50 LBS . ","12171206",,"84.0 CWTS","Some flour and flour blends produced at Dakota Specialty Milling have the potential to be contaminated with pliable metal wire mesh fragments from a defective flour sifter.",2/14/2013,"02/14/2013",3/20/2013,"03/20/2013"
"Food",64368,"Ongoing","Dakota Specialty Milling, Inc","Fargo","ND","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","AZ, AR, CA, GA, HI, IL, IN, KS, MA, MI, MN, MO, NY, ND, OH, PA, TN, TX, VA, WA, WI.","F-1087-2013","Class II","40154, SPECIALTY SG WHOLE WHEAT BLEND ( WHOLE WHEAT FLOUR, WHEAT BRAN, WHEAT), DAKOTA SPECIALTY MILLING, INC., FARGO, ND , 1 Net WT 50 LBS. ","1031120311011203 11081203 11291203 11301203 ",,"1,206.5 CWTS","Some flour and flour blends produced at Dakota Specialty Milling have the potential to be contaminated with pliable metal wire mesh fragments from a defective flour sifter.",2/14/2013,"02/14/2013",3/20/2013,"03/20/2013"
"Food",64368,"Ongoing","Dakota Specialty Milling, Inc","Fargo","ND","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","AZ, AR, CA, GA, HI, IL, IN, KS, MA, MI, MN, MO, NY, ND, OH, PA, TN, TX, VA, WA, WI.","F-1121-2013","Class II","4060805, ORGANIC HARD WHOLE WHEAT PASTRY FLOUR(ORGANIC WHEAT), DAKOTA SPECIALTY MILLING, INC., FARGO, ND , NET WT 50 LBS.. ","830120312131203 ",,"457.0000","Some flour and flour blends produced at Dakota Specialty Milling have the potential to be contaminated with pliable metal wire mesh fragments from a defective flour sifter.",2/14/2013,"02/14/2013",3/20/2013,"03/20/2013"
"Food",64368,"Ongoing","Dakota Specialty Milling, Inc","Fargo","ND","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","AZ, AR, CA, GA, HI, IL, IN, KS, MA, MI, MN, MO, NY, ND, OH, PA, TN, TX, VA, WA, WI.","F-1075-2013","Class II","10021 RM Honey Oat Bran Mixture - Hong Kong / Thailand (oats, oat bran, oat flour), Roman Meal Company, Tacoma, Washington, Net WT 20 KILOS. ","Hong Kong5111205 8291205 Thailand 5211205 8031205 8221205 8291205 ",,"507.9400 CWTS = (62.6120 Hong Kong, 445.3280 Thailand)","Some flour and flour blends produced at Dakota Specialty Milling have the potential to be contaminated with pliable metal wire mesh fragments from a defective flour sifter.",2/14/2013,"02/14/2013",3/20/2013,"03/20/2013"
"Food",64368,"Ongoing","Dakota Specialty Milling, Inc","Fargo","ND","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","AZ, AR, CA, GA, HI, IL, IN, KS, MA, MI, MN, MO, NY, ND, OH, PA, TN, TX, VA, WA, WI.","F-1110-2013","Class II","42300, KASHI COARSE 7 GRAIN BLEND ( RYE, WHEAT BRAN, WHOLE WHEAT FLOUR, OATS, BARLEY, YELLOW CORN, MILLET, BROWN RICE), DAKOTA SPECIALTY MILLING, INC., FARGO, ND , 1 NET WT. 50 LBS . ","32612033271203 4091203 4101203 5031203 5211203 6121203 6181203 6291203 6301204 7011203 7091203 7301203 7311203 8281203 9131203 10021203 10031203 10121203 10161203 10181203 10261203 10291203 11301203 12271203 1021303 1081303 ",,"5,052.0000 CWTS","Some flour and flour blends produced at Dakota Specialty Milling have the potential to be contaminated with pliable metal wire mesh fragments from a defective flour sifter.",2/14/2013,"02/14/2013",3/20/2013,"03/20/2013"
"Food",64368,"Ongoing","Dakota Specialty Milling, Inc","Fargo","ND","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","AZ, AR, CA, GA, HI, IL, IN, KS, MA, MI, MN, MO, NY, ND, OH, PA, TN, TX, VA, WA, WI.","F-1124-2013","Class II","40735, SPECIALTY DAKOTA 12 GRAIN BLEND 100 (WHEAT, OATS, BARLEY, RYE, TRICALE, MILLET, BROWN RICE, BULGAR WHEAT, YELLOW CORN, BUCKWHEAT, SPELT, AMARANTH) DAKOTA SPECIALTY MILLING, INC., FARGO, ND NET WT 50 LBS.. ","3231205 4161205 4191203 4251203 4261203 6291203 7021203 9102103 11201303 1031303",,"1732.5000 CWTS","Some flour and flour blends produced at Dakota Specialty Milling have the potential to be contaminated with pliable metal wire mesh fragments from a defective flour sifter.",2/14/2013,"02/14/2013",3/20/2013,"03/20/2013"
"Food",64368,"Ongoing","Dakota Specialty Milling, Inc","Fargo","ND","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","AZ, AR, CA, GA, HI, IL, IN, KS, MA, MI, MN, MO, NY, ND, OH, PA, TN, TX, VA, WA, WI.","F-1108-2013","Class II","42208, WHOLE GRAIN FLOUR BLEND( MILLET, TRITICALE, RYE, BROWN RICE, BARLEY), DAKOTA SPECIALTY MILLING, INC., FARGO, ND , 1 NET WT. 50 LBS . ","21412032281203 3021203 4171203 5101203 5231203 7081203 8061203 9101203 9121203 11021203 11291203 12221203 ",,"1,378.0000 CWTS","Some flour and flour blends produced at Dakota Specialty Milling have the potential to be contaminated with pliable metal wire mesh fragments from a defective flour sifter.",2/14/2013,"02/14/2013",3/20/2013,"03/20/2013"
"Food",64368,"Ongoing","Dakota Specialty Milling, Inc","Fargo","ND","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","AZ, AR, CA, GA, HI, IL, IN, KS, MA, MI, MN, MO, NY, ND, OH, PA, TN, TX, VA, WA, WI.","F-1093-2013","Class II","41406, MULTI GRAIN WHOLE MEAL FLOUR BLEND 100( WHITE WHEAT, TRITICALE, OATS, RYE, BARLEY, MILLET, BUCKWHEAT, BROWN RICE), DAKOTA SPECIALTY MILLING, INC., FARGO, ND , 1 Net WT 50 LBS. ","21512033161203 3191203 4041203 4181203 4191203 5141203 6011203 6031203 7101203 8061203 8281203 9271203 10171203 11051203 11061203 11121203 11131203 12061203 ",,"2,003.5000 CWTS","Some flour and flour blends produced at Dakota Specialty Milling have the potential to be contaminated with pliable metal wire mesh fragments from a defective flour sifter.",2/14/2013,"02/14/2013",3/20/2013,"03/20/2013"
"Food",64368,"Ongoing","Dakota Specialty Milling, Inc","Fargo","ND","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","AZ, AR, CA, GA, HI, IL, IN, KS, MA, MI, MN, MO, NY, ND, OH, PA, TN, TX, VA, WA, WI.","F-1076-2013","Class II","10058-T, RM Multigrain W/Calcium Mixture - Thailand (wheat bran, yellow corn flour, oats, calcium carbonate, millet flour, yellow flax, stabilized wheat germ), Roman Meal Company, Tacoma, Washington, Net WT 20 KILOS. ","32912054241205 5221205 8061206 8271205 8301205 ",,"634.9170 CWTS","Some flour and flour blends produced at Dakota Specialty Milling have the potential to be contaminated with pliable metal wire mesh fragments from a defective flour sifter.",2/14/2013,"02/14/2013",3/20/2013,"03/20/2013"
"Food",64368,"Ongoing","Dakota Specialty Milling, Inc","Fargo","ND","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","AZ, AR, CA, GA, HI, IL, IN, KS, MA, MI, MN, MO, NY, ND, OH, PA, TN, TX, VA, WA, WI.","F-1091-2013","Class II","40730, SPECIALTY DAKOTA 12 GRAIN BLEND 200( WHEAT, OATS , BARLEY, RYE, TRICALE, MILLET, BROWN RICE, BULGUR WHEAT, YELLOW CORN, BUCKWHEAT, SPELT, AMARANTH), DAKOTA SPECIALTY MILLING, INC., FARGO, ND , 1 Net WT 50 LBS. ","32812054171205 4181205 5041205 5291205 6221205 7241205 8171205 8301205 8311205 9041205 10011205 10021205 10241205 11211205 11261205 11291205 12281205 1041305 ",,"1,838.5000 CWTS","Some flour and flour blends produced at Dakota Specialty Milling have the potential to be contaminated with pliable metal wire mesh fragments from a defective flour sifter.",2/14/2013,"02/14/2013",3/20/2013,"03/20/2013"
"Food",64368,"Ongoing","Dakota Specialty Milling, Inc","Fargo","ND","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","AZ, AR, CA, GA, HI, IL, IN, KS, MA, MI, MN, MO, NY, ND, OH, PA, TN, TX, VA, WA, WI.","F-1117-2013","Class II","4060685, WHOLE MEAL TRITICALE FLOUR (TRITICALE), DAKOTA SPECIALTY MILLING, INC., FARGO, ND , 1 NET WT 50 LBS.. ","30212036011203 6211203 8011203 8141203 10161203 ",,"95.5000","Some flour and flour blends produced at Dakota Specialty Milling have the potential to be contaminated with pliable metal wire mesh fragments from a defective flour sifter.",2/14/2013,"02/14/2013",3/20/2013,"03/20/2013"
"Food",64368,"Ongoing","Dakota Specialty Milling, Inc","Fargo","ND","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","AZ, AR, CA, GA, HI, IL, IN, KS, MA, MI, MN, MO, NY, ND, OH, PA, TN, TX, VA, WA, WI.","F-1096-2013","Class II","90341440, BOULDER 7 WHOLE GRAIN BLEND ( MILO: SORGHUM, MILLET, BROWN RICE, WHOLE GRAIN CORN, TEFF, AMARANTH, QUINOA) DAKOTA SPECIALTY MILLING, INC., FARGO, ND , 50. LBS. ","71912039261203 10091203 11051203 ",,"255.5000 CWTS","Some flour and flour blends produced at Dakota Specialty Milling have the potential to be contaminated with pliable metal wire mesh fragments from a defective flour sifter.",2/14/2013,"02/14/2013",3/20/2013,"03/20/2013"
"Food",64368,"Ongoing","Dakota Specialty Milling, Inc","Fargo","ND","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","AZ, AR, CA, GA, HI, IL, IN, KS, MA, MI, MN, MO, NY, ND, OH, PA, TN, TX, VA, WA, WI.","F-1081-2013","Class II","13006, Roman Meal Twelve Grain(wheat bran, sunflower seed, stabilized wheat germ, wheat, barley, sesame seed, Millet, yellow corn, flaxseed, Triticale, Oats, Rye, rice flour, black malt, buckwheat flour, spelt, kamut flour, amaranth flour), Roman Meal Company, Tacoma, Washington, 1 Net WT 50 LBS. ","32312063261206 5011206 5021206 7181206 7191206 7201206 8291206 8301206 10121206 10151206 11281206 11291206 ",,"1,773.0000 CWTS","Some flour and flour blends produced at Dakota Specialty Milling have the potential to be contaminated with pliable metal wire mesh fragments from a defective flour sifter.",2/14/2013,"02/14/2013",3/20/2013,"03/20/2013"
"Food",64368,"Ongoing","Dakota Specialty Milling, Inc","Fargo","ND","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","AZ, AR, CA, GA, HI, IL, IN, KS, MA, MI, MN, MO, NY, ND, OH, PA, TN, TX, VA, WA, WI.","F-1100-2013","Class II","41653, MIX 8 GRAIN INSTANTIZED( OATS, WHEAT, BARLEY, TRITICALE, WHITE WHEAT, RYE, AMARANTH, FLAXSEED, WHEAT GERM, YELLOW CORN), DAKOTA SPECIALTY MILLING, INC., FARGO, ND , 1 NET WT. 50 LBS . ","22812054041205 4231205 5161205 6011205 6131205 6141205 7181205 7191205 8081205 8091205 8231205 8241205 9051205 9061205 10041205 10231205 11081205 11091205 11201205 12111205 1091305 ",,"2,748.5000 CWTS","Some flour and flour blends produced at Dakota Specialty Milling have the potential to be contaminated with pliable metal wire mesh fragments from a defective flour sifter.",2/14/2013,"02/14/2013",3/20/2013,"03/20/2013"
"Food",64368,"Ongoing","Dakota Specialty Milling, Inc","Fargo","ND","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","AZ, AR, CA, GA, HI, IL, IN, KS, MA, MI, MN, MO, NY, ND, OH, PA, TN, TX, VA, WA, WI.","F-1077-2013","Class II","10073, Roman Meal Enhanced Healthy White Mix (sugarcane fiber, whole meal barley flour, white corn, wheat starch, oats, vitamins), Roman Meal Company, Tacoma, Washington, 1 Net WT 50 LBS. ","40212034271206 5181206 6131206 6291206 7171205 8101205 8161205 8291205 9101206 9261206 10041206 10221206 11151206 12111206 12211206 ",,"577.5000 CWTS","Some flour and flour blends produced at Dakota Specialty Milling have the potential to be contaminated with pliable metal wire mesh fragments from a defective flour sifter.",2/14/2013,"02/14/2013",3/20/2013,"03/20/2013"
"Food",64368,"Ongoing","Dakota Specialty Milling, Inc","Fargo","ND","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","AZ, AR, CA, GA, HI, IL, IN, KS, MA, MI, MN, MO, NY, ND, OH, PA, TN, TX, VA, WA, WI.","F-1123-2013","Class II","4060570, DARK RYE FLOUR (RYE), DAKOTA SPECIALTY MILLING, INC., FARGO, ND NET WT 50 LBS.. ","2131203 3021203 3051203 4301203 6141203 6151203 6181203 9191203",,"862.5000 CWTS","Some flour and flour blends produced at Dakota Specialty Milling have the potential to be contaminated with pliable metal wire mesh fragments from a defective flour sifter.",2/14/2013,"02/14/2013",3/20/2013,"03/20/2013"
"Food",64368,"Ongoing","Dakota Specialty Milling, Inc","Fargo","ND","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","AZ, AR, CA, GA, HI, IL, IN, KS, MA, MI, MN, MO, NY, ND, OH, PA, TN, TX, VA, WA, WI.","F-1106-2013","Class II","42204, MULTIGRAIN MIX FOR P.S. BREAD ( WHITE WHEAT, OATS, BARLEY, TRICALE, BROWN FLAX, CORN, SESAME SEED, POTATO FLAKES, WHEAT, RYE, WHEAT BRAN), DAKOTA SPECIALTY MILLING, INC., FARGO, ND , 1 NET WT. 50 LBS . ","30112054111205 4271205 5041205 5071205 5211205 6151205 7061205 8081205 8131205 9121205 9131205 9251205 10311205 11131205 11291205 12141205 12151205 1021305 1031305 ",,"2,006.0000 CWTS","Some flour and flour blends produced at Dakota Specialty Milling have the potential to be contaminated with pliable metal wire mesh fragments from a defective flour sifter.",2/14/2013,"02/14/2013",3/20/2013,"03/20/2013"
"Food",64368,"Ongoing","Dakota Specialty Milling, Inc","Fargo","ND","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","AZ, AR, CA, GA, HI, IL, IN, KS, MA, MI, MN, MO, NY, ND, OH, PA, TN, TX, VA, WA, WI.","F-1113-2013","Class II","4060564, LIGHT RYE FLOUR (RYE), DAKOTA SPECIALTY MILLING, INC., FARGO, ND, NET WT. 50 LBS . ","30512034131203 8091203 ",,"35.0000 CWTS","Some flour and flour blends produced at Dakota Specialty Milling have the potential to be contaminated with pliable metal wire mesh fragments from a defective flour sifter.",2/14/2013,"02/14/2013",3/20/2013,"03/20/2013"
"Food",64368,"Ongoing","Dakota Specialty Milling, Inc","Fargo","ND","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","AZ, AR, CA, GA, HI, IL, IN, KS, MA, MI, MN, MO, NY, ND, OH, PA, TN, TX, VA, WA, WI.","F-1097-2013","Class II","41511, 7 GRAIN BLEND - SOY FREE( WHEAT, WHEAT BRAN, RYE, BARLEY, TRITICALE, RICE FLOUR, OATS, CORN) DAKOTA SPECIALTY MILLING, INC., FARGO, ND , 19 NET WT. 50. LBS. ","52512056221205 7241205 8041205 8201205 9051205 10171205 11081205 ",,"236.5000 CWTS","Some flour and flour blends produced at Dakota Specialty Milling have the potential to be contaminated with pliable metal wire mesh fragments from a defective flour sifter.",2/14/2013,"02/14/2013",3/20/2013,"03/20/2013"
"Food",64368,"Ongoing","Dakota Specialty Milling, Inc","Fargo","ND","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","AZ, AR, CA, GA, HI, IL, IN, KS, MA, MI, MN, MO, NY, ND, OH, PA, TN, TX, VA, WA, WI.","F-1086-2013","Class II","40145, SPECIALTY MULTIGRAIN BASE ( WHEAT BRAN, SUNFLOWER, WHEAT, OAT BRAN, RYE, OATS, OAT FLOUR, FLAXSEED, WHEAT GERM), DAKOTA SPECIALTY MILLING, INC., FARGO, ND , 1 Net WT 50 LBS. ","30612033151203 4161203 5021203 5101203 6061203 6181203 7181203 8011203 8161203 9251203 10101203 11271203 11281203 12291203 ",,"1,354.0000 CWTS","Some flour and flour blends produced at Dakota Specialty Milling have the potential to be contaminated with pliable metal wire mesh fragments from a defective flour sifter.",2/14/2013,"02/14/2013",3/20/2013,"03/20/2013"
"Food",64368,"Ongoing","Dakota Specialty Milling, Inc","Fargo","ND","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","AZ, AR, CA, GA, HI, IL, IN, KS, MA, MI, MN, MO, NY, ND, OH, PA, TN, TX, VA, WA, WI.","F-1122-2013","Class II","4060567, MEDIUM RYE FLOUR (RYE), DAKOTA SPECIALTY MILLING, INC., FARGO, ND NET WT 50 LBS.. ","4051203 4131203 4201203 4221203 4231203 5181203 5211203 6041203 11081203",,"858.5000 CWTS","Some flour and flour blends produced at Dakota Specialty Milling have the potential to be contaminated with pliable metal wire mesh fragments from a defective flour sifter.",2/14/2013,"02/14/2013",3/20/2013,"03/20/2013"
"Food",64368,"Ongoing","Dakota Specialty Milling, Inc","Fargo","ND","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","AZ, AR, CA, GA, HI, IL, IN, KS, MA, MI, MN, MO, NY, ND, OH, PA, TN, TX, VA, WA, WI.","F-1098-2013","Class II","41512 and 41512-T, IBC 12 WHOLE GRAIN BLEND( WHEAT, OATS, BARLEY , RYE, TRITICALE, MILLET, BUCKWHEAT, YELLOW CORN, SORGHUM, BROWN RICE, QUINOA, AMARANTH) DAKOTA SPECIALTY MILLING, INC., FARGO, ND , 1 NET WT. 50. LBS and 1,750 LBS. ","41512: 3081201 3181201 3191201 4031201 5031202 5301201 6211201 6221201 7111201 7251201 8071201 8081201 8211201 8221201 9071201 9081201 10101201 10241201 41512-T: 3081201 4021201 4031201 5301201 7101201 7241201 8211201 9071201 10301201 ",,"10,359.5000 ( 41512) + 3080.0000 ( 41512-T) = 13,439.5 CWTS","Some flour and flour blends produced at Dakota Specialty Milling have the potential to be contaminated with pliable metal wire mesh fragments from a defective flour sifter.",2/14/2013,"02/14/2013",3/20/2013,"03/20/2013"
"Food",64368,"Ongoing","Dakota Specialty Milling, Inc","Fargo","ND","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","AZ, AR, CA, GA, HI, IL, IN, KS, MA, MI, MN, MO, NY, ND, OH, PA, TN, TX, VA, WA, WI.","F-1109-2013","Class II","42209, QUADRUPLE WHEAT BLEND( WHITE WHEAT, SPELT, BUCKWHEAT, CALCIUM SULFATE, FERROUS SULFATE-CONTAINS WHEAT STARCH), DAKOTA SPECIALTY MILLING, INC., FARGO, ND , 1 NET WT. 50 LBS . ","31612033291203 5151203 5161203 6111203 6121203 7031203 8021203 9041203 9261203 9271203 10311203 11011203 11121203 12071203 12101203 12271203 12281203 ",,"1,397.5000 CWTS","Some flour and flour blends produced at Dakota Specialty Milling have the potential to be contaminated with pliable metal wire mesh fragments from a defective flour sifter.",2/14/2013,"02/14/2013",3/20/2013,"03/20/2013"
"Food",64368,"Ongoing","Dakota Specialty Milling, Inc","Fargo","ND","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","AZ, AR, CA, GA, HI, IL, IN, KS, MA, MI, MN, MO, NY, ND, OH, PA, TN, TX, VA, WA, WI.","F-1119-2013","Class II","4060801, ORGANIC HIGH GLUTEN REFINED HARD RED SPRING WHEAT FLOUR(ORGANIC WHEAT), DAKOTA SPECIALTY MILLING, INC., FARGO, ND , 1 NET WT 50 LBS.. ","12041203",,"50.0000","Some flour and flour blends produced at Dakota Specialty Milling have the potential to be contaminated with pliable metal wire mesh fragments from a defective flour sifter.",2/14/2013,"02/14/2013",3/20/2013,"03/20/2013"
"Food",64368,"Ongoing","Dakota Specialty Milling, Inc","Fargo","ND","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","AZ, AR, CA, GA, HI, IL, IN, KS, MA, MI, MN, MO, NY, ND, OH, PA, TN, TX, VA, WA, WI.","F-1111-2013","Class II","4050100, ORGANIC WHOLE WHEAT BREAD FLOUR (ORGANIC WHEAT), DAKOTA SPECIALTY MILLING, INC., FARGO, ND , 1 NET WT. 50 LBS . ","30612033141203 3151203 4141203 4151203 4161203 5111203 5131203 5141203 6061203 6071203 7021203 7031203 7051203 7301203 8291203 9211203 9241203 10041203 10051203 ",,"3,215.5000 CWTS","Some flour and flour blends produced at Dakota Specialty Milling have the potential to be contaminated with pliable metal wire mesh fragments from a defective flour sifter.",2/14/2013,"02/14/2013",3/20/2013,"03/20/2013"
"Food",64368,"Ongoing","Dakota Specialty Milling, Inc","Fargo","ND","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","AZ, AR, CA, GA, HI, IL, IN, KS, MA, MI, MN, MO, NY, ND, OH, PA, TN, TX, VA, WA, WI.","F-1103-2013","Class II","41681, NICKLES 9 GRAIN BLEND ( OATS, WHEAT, BARLEY, TRITICALE, WHITE WHEAT, BROWN FLAX, RYE, AMARANT, WHEAT GERM, CORN, BROWN RICE), DAKOTA SPECIALTY MILLING, INC., FARGO, ND , 1 NET WT. 50 LBS . ","629120510031205 10161205 ",,"836.5000 CWTS","Some flour and flour blends produced at Dakota Specialty Milling have the potential to be contaminated with pliable metal wire mesh fragments from a defective flour sifter.",2/14/2013,"02/14/2013",3/20/2013,"03/20/2013"
"Food",64368,"Ongoing","Dakota Specialty Milling, Inc","Fargo","ND","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","AZ, AR, CA, GA, HI, IL, IN, KS, MA, MI, MN, MO, NY, ND, OH, PA, TN, TX, VA, WA, WI.","F-1105-2013","Class II","42203, OCTOBER GRAINS & SEEDS MIX ( OATS, GOLDEN FLAX, SUNFLOWER, SESAME SEED, WHITE WHEAT, OAT FLOUR, BARLEY, WHET BRAN, CORN, MILLET, AMARANTH), DAKOTA SPECIALTY MILLING, INC., FARGO, ND , 1 NET WT. 50 LBS . ","41712055161205 6081205 7111205 7301205 10121205 11081205 12181205 1031305 ",,"221.0000 CWT","Some flour and flour blends produced at Dakota Specialty Milling have the potential to be contaminated with pliable metal wire mesh fragments from a defective flour sifter.",2/14/2013,"02/14/2013",3/20/2013,"03/20/2013"
"Food",64368,"Ongoing","Dakota Specialty Milling, Inc","Fargo","ND","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","AZ, AR, CA, GA, HI, IL, IN, KS, MA, MI, MN, MO, NY, ND, OH, PA, TN, TX, VA, WA, WI.","F-1116-2013","Class II","4060625, WHOLE MEAL BARLEY FLOUR (BARLEY), DAKOTA SPECIALTY MILLING, INC., FARGO, ND , 0 NET WT 50 LBS.. ","3291203",,"10.0000","Some flour and flour blends produced at Dakota Specialty Milling have the potential to be contaminated with pliable metal wire mesh fragments from a defective flour sifter.",2/14/2013,"02/14/2013",3/20/2013,"03/20/2013"
"Food",64368,"Ongoing","Dakota Specialty Milling, Inc","Fargo","ND","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","AZ, AR, CA, GA, HI, IL, IN, KS, MA, MI, MN, MO, NY, ND, OH, PA, TN, TX, VA, WA, WI.","F-1084-2013","Class II","40133, SARA LEE SPECIALTY 8 GRAIN BLEND 100 (SUNFLOWER, WHEAT, OATS, RYE, BARLEY, WHOLE MEAL YELLOW CORN, MILLET, TRITICALE, RYE FLOUR), DAKOTA SPECIALTY MILLING, INC., FARGO, ND , 1 Net WT 50 LBS. ","31412033151203 5011203 5021203 6201203 6061203 6071203 7181203 7191203 8301203 8311204 9141203 9171203 9271203 9281203 10191203 10221203 11121203 11281203 12131203 1071303 ",,"4,265.0000 CWTS","Some flour and flour blends produced at Dakota Specialty Milling have the potential to be contaminated with pliable metal wire mesh fragments from a defective flour sifter.",2/14/2013,"02/14/2013",3/20/2013,"03/20/2013"
"Food",64368,"Ongoing","Dakota Specialty Milling, Inc","Fargo","ND","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","AZ, AR, CA, GA, HI, IL, IN, KS, MA, MI, MN, MO, NY, ND, OH, PA, TN, TX, VA, WA, WI.","F-1102-2013","Class II","41678, NICKLES 12 GRAIN BLEND ( SUNFLOWER, WHEAT, OATS, WHOLE WHEAT FLOUR, SESAME SEEDS, FLAXSEED, BARLEY, RYE, TRICALE, BROWN RICE, MILLET, YELLOW CORN, BUCKWHEAT, BULGUR WHEAT, AMARANTH, QUINOA), DAKOTA SPECIALTY MILLING, INC., FARGO, ND , 1 NET WT. 50 LBS . ","31912053201205 4131205 4261205 4271205 5291205 5301205 7021205 7031205 7301205 7311205 8161205 8171205 9061205 9071205 9101205 10151205 10161205 11091205 11101205 12051205 12061205 12071205 12281205 12291205 ",,"4,814.0000 CWTS","Some flour and flour blends produced at Dakota Specialty Milling have the potential to be contaminated with pliable metal wire mesh fragments from a defective flour sifter.",2/14/2013,"02/14/2013",3/20/2013,"03/20/2013"
"Food",64368,"Ongoing","Dakota Specialty Milling, Inc","Fargo","ND","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","AZ, AR, CA, GA, HI, IL, IN, KS, MA, MI, MN, MO, NY, ND, OH, PA, TN, TX, VA, WA, WI.","F-1115-2013","Class II","4060610, SPECIALTY PASTRY FLOUR (SOFT WHITE WHOLE WHEAT), DAKOTA SPECIALTY MILLING, INC., FARGO, ND , 1 NET WT 50 LBS.. ","32912035071203 5081203 7301203 8101203 10081203 ",,"647.5000","Some flour and flour blends produced at Dakota Specialty Milling have the potential to be contaminated with pliable metal wire mesh fragments from a defective flour sifter.",2/14/2013,"02/14/2013",3/20/2013,"03/20/2013"
"Food",64368,"Ongoing","Dakota Specialty Milling, Inc","Fargo","ND","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","AZ, AR, CA, GA, HI, IL, IN, KS, MA, MI, MN, MO, NY, ND, OH, PA, TN, TX, VA, WA, WI.","F-1120-2013","Class II","4060804, ORGANIC ALL PURPOSE FLOUR(ORGANIC WHEAT), DAKOTA SPECIALTY MILLING, INC., FARGO, ND , 1 NET WT 50 LBS.. ","831120312151712 ",,"1,051.8000","Some flour and flour blends produced at Dakota Specialty Milling have the potential to be contaminated with pliable metal wire mesh fragments from a defective flour sifter.",2/14/2013,"02/14/2013",3/20/2013,"03/20/2013"
"Food",64368,"Ongoing","Dakota Specialty Milling, Inc","Fargo","ND","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","AZ, AR, CA, GA, HI, IL, IN, KS, MA, MI, MN, MO, NY, ND, OH, PA, TN, TX, VA, WA, WI.","F-1094-2013","Class II","41410, 3 FLOUR BLEND( OATS, BARLEY, MILLET), DAKOTA SPECIALTY MILLING, INC., FARGO, ND , 1 Net WT 50 LBS. ","1021303",,"52.5000 CWTS","Some flour and flour blends produced at Dakota Specialty Milling have the potential to be contaminated with pliable metal wire mesh fragments from a defective flour sifter.",2/14/2013,"02/14/2013",3/20/2013,"03/20/2013"
"Food",64368,"Ongoing","Dakota Specialty Milling, Inc","Fargo","ND","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","AZ, AR, CA, GA, HI, IL, IN, KS, MA, MI, MN, MO, NY, ND, OH, PA, TN, TX, VA, WA, WI.","F-1104-2013","Class II","41757, SPECIALTY ANCIENT GRAIN FLOUR BLEND ( SPELT, OATS KAMUT, AMARANTH, MILLET, QUINOA, TEFF), DAKOTA SPECIALTY MILLING, INC., FARGO, ND , 1 NET WT. 50 LBS . ","22112063051206 3201206 3211206 5111206 6271206 7031206 8091206 9201206 10181206 11151206 12121206 12131206 1111306 ",,"570.0000 CWTS","Some flour and flour blends produced at Dakota Specialty Milling have the potential to be contaminated with pliable metal wire mesh fragments from a defective flour sifter.",2/14/2013,"02/14/2013",3/20/2013,"03/20/2013"
"Food",64368,"Ongoing","Dakota Specialty Milling, Inc","Fargo","ND","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","AZ, AR, CA, GA, HI, IL, IN, KS, MA, MI, MN, MO, NY, ND, OH, PA, TN, TX, VA, WA, WI.","F-1101-2013","Class II","41672, SPECIALTY LIGHT WHITE BLEND 200 ( CELLULOSE FIBER, WHEAT FLOUR, SALT, CELLULOSE GUM, GUAR GUM, CALCIUM PROPIONATE), DAKOTA SPECIALTY MILLING, INC., FARGO, ND , 19 NET WT. 50 LBS . ","12171206 ",,"77.0 CWTS","Some flour and flour blends produced at Dakota Specialty Milling have the potential to be contaminated with pliable metal wire mesh fragments from a defective flour sifter.",2/14/2013,"02/14/2013",3/20/2013,"03/20/2013"
"Food",64368,"Ongoing","Dakota Specialty Milling, Inc","Fargo","ND","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","AZ, AR, CA, GA, HI, IL, IN, KS, MA, MI, MN, MO, NY, ND, OH, PA, TN, TX, VA, WA, WI.","F-1089-2013","Class II","40450, NORTH DAKOTA MULTI 7 GRAIN BREAD MIX( WHEAT FLOUR, MALTED BARLEY FLOUR, NIACIN, IRON..., RIBOFLAVIN,FOLIC ACID, SUGAR ASCORBIC ACID, NUTRI SOY FLOUR, WHEAT..., BARLEY FLOUR, RYE FLOUR, FLAX MEAL....., OAT BRAN, ROLLED OATS, NONFAT DRY MILK, DRY YEAST), DAKOTA SPECIALTY MILLING, INC., FARGO, ND , Net WT 15.2 OZ. CHECK LABEL","10311202",,"463.0000 CWTS","Some flour and flour blends produced at Dakota Specialty Milling have the potential to be contaminated with pliable metal wire mesh fragments from a defective flour sifter.",2/14/2013,"02/14/2013",3/20/2013,"03/20/2013"
"Food",64368,"Ongoing","Dakota Specialty Milling, Inc","Fargo","ND","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","AZ, AR, CA, GA, HI, IL, IN, KS, MA, MI, MN, MO, NY, ND, OH, PA, TN, TX, VA, WA, WI.","F-1114-2013","Class II","4060570-T, TOTE - DARK RYE FLOUR, (WHOLE RYE), DAKOTA SPECIALTY MILLING, INC., FARGO, ND , NET WT. 1,750 LBS ","50912035241205 5251203 6141203 6151203 7061203 7101203 7131203 8081203 9061203 10101203 11071203 11271203 12271203 12281203 12291203",,"4,621.8700 CWTS","Some flour and flour blends produced at Dakota Specialty Milling have the potential to be contaminated with pliable metal wire mesh fragments from a defective flour sifter.",2/14/2013,"02/14/2013",3/20/2013,"03/20/2013"
"Food",64368,"Ongoing","Dakota Specialty Milling, Inc","Fargo","ND","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","AZ, AR, CA, GA, HI, IL, IN, KS, MA, MI, MN, MO, NY, ND, OH, PA, TN, TX, VA, WA, WI.","F-1080-2013","Class II","10209, Roman Meal New 12 Grain Mix (wheat bran, sunflower, wheat germ, wheat, barley, sesame seed, Millet, yellow corn, brown flax, Triticale, Oats, Rye, buckwheat, spelt, Brown Rice, kamut flour, amaranth flour), Roman Meal Company, Tacoma, Washington, 1 Net WT 50 LBS. ","22912033221203 5081203 5091203 6051203 6061203 6271203 6281203 8031203 9051203 10111203 10121203 11151203 12141203 12161203 12171203 1071303 ",,"3,000.5000 CWTS","Some flour and flour blends produced at Dakota Specialty Milling have the potential to be contaminated with pliable metal wire mesh fragments from a defective flour sifter.",2/14/2013,"02/14/2013",3/20/2013,"03/20/2013"
"Food",64368,"Ongoing","Dakota Specialty Milling, Inc","Fargo","ND","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","AZ, AR, CA, GA, HI, IL, IN, KS, MA, MI, MN, MO, NY, ND, OH, PA, TN, TX, VA, WA, WI.","F-1090-2013","Class II","40632, SPECIALTY GRANNY GRAINS BLEND ( WHEAT BRAN, WHEAT, OATS , BARLEY, RYE), DAKOTA SPECIALTY MILLING, INC., FARGO, ND , 19 Net WT 40 LBS. ","1116120311191203 ",,"402.4000 CWTS","Some flour and flour blends produced at Dakota Specialty Milling have the potential to be contaminated with pliable metal wire mesh fragments from a defective flour sifter.",2/14/2013,"02/14/2013",3/20/2013,"03/20/2013"
"Food",64368,"Ongoing","Dakota Specialty Milling, Inc","Fargo","ND","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","AZ, AR, CA, GA, HI, IL, IN, KS, MA, MI, MN, MO, NY, ND, OH, PA, TN, TX, VA, WA, WI.","F-1088-2013","Class II","40180, SPECIALTY 9 GRAIN BLEND 400 ( OATS, WHITE WHEAT, BARLEY, RYE, TRITICALE, SPELT, BUCKWHEAT, MILLET, BROWN RICE), DAKOTA SPECIALTY MILLING, INC., FARGO, ND , 1 Net WT 50 LBS. ","41712056261205 6271205 7251205 7261205 8171205 11011205 11101205 11121205 11301205 12051205 12211205 1071305 1081305 ",,"1,078.0000 CWTS","Some flour and flour blends produced at Dakota Specialty Milling have the potential to be contaminated with pliable metal wire mesh fragments from a defective flour sifter.",2/14/2013,"02/14/2013",3/20/2013,"03/20/2013"
"Food",64368,"Ongoing","Dakota Specialty Milling, Inc","Fargo","ND","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","AZ, AR, CA, GA, HI, IL, IN, KS, MA, MI, MN, MO, NY, ND, OH, PA, TN, TX, VA, WA, WI.","F-1118-2013","Class II","4060800, ORGANIC WHOLE HARD WHITE WHEAT FLOUR (ORGANIC WHEAT), DAKOTA SPECIALTY MILLING, INC., FARGO, ND , 1 NET WT 50 LBS.. ","8091203",,"328.0000","Some flour and flour blends produced at Dakota Specialty Milling have the potential to be contaminated with pliable metal wire mesh fragments from a defective flour sifter.",2/14/2013,"02/14/2013",3/20/2013,"03/20/2013"
"Food",64368,"Ongoing","Dakota Specialty Milling, Inc","Fargo","ND","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","AZ, AR, CA, GA, HI, IL, IN, KS, MA, MI, MN, MO, NY, ND, OH, PA, TN, TX, VA, WA, WI.","F-1085-2013","Class II","40134, SARA LEE 12 WHOLE GRAIN BLEND 100 ( WHEAT, OATS, RYE, BARLEY, WHOLE GRAIN CORN, SUNFLOWER, BROWN FLAXSEED, MILLET, TRITICALE, BROWN RICE, BUCKWHEAT, WHOLE MEAL AMARANTH FLOUR, SPELT, SORGHUM) DAKOTA SPECIALTY MILLING, INC., FARGO, ND , 1 Net WT 50 LBS. ","32012054231205 4241205 5161205 6031205 6251205 8141201 10021201 11081201 1071301 ",,"4,457.0000 CWTS","Some flour and flour blends produced at Dakota Specialty Milling have the potential to be contaminated with pliable metal wire mesh fragments from a defective flour sifter.",2/14/2013,"02/14/2013",3/20/2013,"03/20/2013"
"Food",64368,"Ongoing","Dakota Specialty Milling, Inc","Fargo","ND","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","AZ, AR, CA, GA, HI, IL, IN, KS, MA, MI, MN, MO, NY, ND, OH, PA, TN, TX, VA, WA, WI.","F-1074-2013","Class II","10021 Roman Meal Premium Oat Bran Mix ( Oat Flour, Oats, Oat Bran, white Wheat Bran, Red Wheat Bran, Stabilizi...., Wheat Germ), Roman Meal Company, Tacoma, Washington, 1 Net WT 50 LBS. ","40312054181205 5111205 5291205 5301205 6061205 6071205 7051205 7061205 7131205 7161205 8031205 8161205 8221205 8231205 9131205 9261205 10101205 10291205 11131205 11161205 11191205 12071205 12101205 1021305 ",,"3,009.5000 CWTS","Some flour and flour blends produced at Dakota Specialty Milling have the potential to be contaminated with pliable metal wire mesh fragments from a defective flour sifter.",2/14/2013,"02/14/2013",3/20/2013,"03/20/2013"
"Food",64368,"Ongoing","Dakota Specialty Milling, Inc","Fargo","ND","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","AZ, AR, CA, GA, HI, IL, IN, KS, MA, MI, MN, MO, NY, ND, OH, PA, TN, TX, VA, WA, WI.","F-1079-2013","Class II","10204, Roman Meal Multi Whole Grain Mix (Millet, White Wheat, Triticale, Oats, Rye, Barely, Buckwheat, Brown Rice), Roman Meal Company, Tacoma, Washington, 1 Net WT 50 LBS. ","32112063221206 4181206 4191206 4261206 5091206 5211206 6111206 6211203 6291203 7261205 8101206 8271206 9111206 9211206 9241206 10241206 11051206 11211206 12121206 12201206 12211206 ",,"1,365.0000 CWTS","Some flour and flour blends produced at Dakota Specialty Milling have the potential to be contaminated with pliable metal wire mesh fragments from a defective flour sifter.",2/14/2013,"02/14/2013",3/20/2013,"03/20/2013"
"Food",64368,"Ongoing","Dakota Specialty Milling, Inc","Fargo","ND","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","AZ, AR, CA, GA, HI, IL, IN, KS, MA, MI, MN, MO, NY, ND, OH, PA, TN, TX, VA, WA, WI.","F-1095-2013","Class II","41433, SUN CHIP 6 GRAIN BLEND( WHOLE MEAL: BROWN RICE, BUCKWHEAT AND QUINOA), DAKOTA SPECIALTY MILLING, INC., FARGO, ND , ----LBS. ","22412062271206 2281206 2291206 3121206 3131206 3141206 3271206 3281206 4171206 6041206 6051206 6181206 6191206 6251206 6261206 7021206 7061206 8301206 8311206 9041206 12051206 12061206 12071206 12101206 12111206 ",,"5,380.0000 CWTS","Some flour and flour blends produced at Dakota Specialty Milling have the potential to be contaminated with pliable metal wire mesh fragments from a defective flour sifter.",2/14/2013,"02/14/2013",3/20/2013,"03/20/2013"
"Food",64368,"Ongoing","Dakota Specialty Milling, Inc","Fargo","ND","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","AZ, AR, CA, GA, HI, IL, IN, KS, MA, MI, MN, MO, NY, ND, OH, PA, TN, TX, VA, WA, WI.","F-1099-2013","Class II","41631, BLEND DC SOFT MULTIGRAIN BLEND ( WHOLE MEAL OATS, WHOLE MEAL BARLEY. WHOLE MEAL BROWN RICE, WHOLE MEAL CORN, WHOLE FLAXSEED), DAKOTA SPECIALTY MILLING, INC., FARGO, ND , 53 NET WT. 50 LBS . ","31612033311203 4011203 4201203 5101203 5221203 7191203 7201203 8131203 9121203 11061203 11071203 11091203 1031303 ",,"1,146.5000 CWTS","Some flour and flour blends produced at Dakota Specialty Milling have the potential to be contaminated with pliable metal wire mesh fragments from a defective flour sifter.",2/14/2013,"02/14/2013",3/20/2013,"03/20/2013"
"Food",64368,"Ongoing","Dakota Specialty Milling, Inc","Fargo","ND","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","AZ, AR, CA, GA, HI, IL, IN, KS, MA, MI, MN, MO, NY, ND, OH, PA, TN, TX, VA, WA, WI.","F-1112-2013","Class II","4060215, OAT FLOUR (OATS), DAKOTA SPECIALTY MILLING, INC., FARGO, ND , 0 NET WT. 50 LBS . ","22712033231203 3261203 4121203 4131203 5041203 5031203 6011203 6281203 7261203 8231203 9181203 9201203 10031203 10251203 10291203 11161203 1119103 12211203 ",,"3,127.5000","Some flour and flour blends produced at Dakota Specialty Milling have the potential to be contaminated with pliable metal wire mesh fragments from a defective flour sifter.",2/14/2013,"02/14/2013",3/20/2013,"03/20/2013"
"Food",64368,"Ongoing","Dakota Specialty Milling, Inc","Fargo","ND","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","AZ, AR, CA, GA, HI, IL, IN, KS, MA, MI, MN, MO, NY, ND, OH, PA, TN, TX, VA, WA, WI.","F-1082-2013","Class II","40048, SPECIALTY VANILLA GRANOLA (...ATS. WHEAT, SUGAR, OAT FLOUR, CANOLA OIL W/TOCOPHEROLS, BROWN SUGAR, VANILLA EXTRACT, HONEY, SI...., SALT), DAKOTA SPECIALTY MILLING, INC., FARGO, ND , 1 Net WT 40 LBS. ","22412073261207 3271207 3281207 4171207 4181207 6061207 6071207 7101207 8241207 8251207 8271207 11091207 11101207 12051207 12061207 12141207 ",,"3,064.4000 CWTS","Some flour and flour blends produced at Dakota Specialty Milling have the potential to be contaminated with pliable metal wire mesh fragments from a defective flour sifter.",2/14/2013,"02/14/2013",3/20/2013,"03/20/2013"
"Food",64368,"Ongoing","Dakota Specialty Milling, Inc","Fargo","ND","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","AZ, AR, CA, GA, HI, IL, IN, KS, MA, MI, MN, MO, NY, ND, OH, PA, TN, TX, VA, WA, WI.","F-1083-2013","Class II","40120, CANADIAN OAT BASE (OATS. OAT BRAN, OAT FIBER, RYE, SUNFLOWER, OAT FLOUR, WHEAT, BARLEY), DAKOTA SPECIALTY MILLING, INC., FARGO, ND , 1 Net WT 50 LBS. ","41312054161205 5301205 5311205 6131205 8041205 8061205 8291205 9101205 9111205 9271205 11191205 11201205 11271205 12151205 12171205 ",,"1,615.5000 CWTS","Some flour and flour blends produced at Dakota Specialty Milling have the potential to be contaminated with pliable metal wire mesh fragments from a defective flour sifter.",2/14/2013,"02/14/2013",3/20/2013,"03/20/2013"
"Food",64368,"Ongoing","Dakota Specialty Milling, Inc","Fargo","ND","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","AZ, AR, CA, GA, HI, IL, IN, KS, MA, MI, MN, MO, NY, ND, OH, PA, TN, TX, VA, WA, WI.","F-1078-2013","Class II","10200, Roman Meal Barley Mix (Barley), Roman Meal Company, Tacoma, Washington, 1 Net WT 50 LBS. ","42312055091205 6051205 6291205 7171205 7261205 8231205 9251205 10161205 11011205 11131205 12101205 ",,"535.0000 CWTS","Some flour and flour blends produced at Dakota Specialty Milling have the potential to be contaminated with pliable metal wire mesh fragments from a defective flour sifter.",2/14/2013,"02/14/2013",3/20/2013,"03/20/2013"
"Food",64368,"Ongoing","Dakota Specialty Milling, Inc","Fargo","ND","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","AZ, AR, CA, GA, HI, IL, IN, KS, MA, MI, MN, MO, NY, ND, OH, PA, TN, TX, VA, WA, WI.","F-1092-2013","Class II","40740, SPECIALTY 11 GRAIN BLEND ( WHEAT,RYE, TRICALE, CORN, BROWN RICE, OATS, BUCKWHEAT, PARLEY, AMARANTH, MILO, QUINOA), DAKOTA SPECIALTY MILLING, INC., FARGO, ND , 1 Net WT 50 LBS. ","30112065181206 6271206 8021206 9171206 11011206 11301206 12131206 1021306 ",,"384.5000 CWTS","Some flour and flour blends produced at Dakota Specialty Milling have the potential to be contaminated with pliable metal wire mesh fragments from a defective flour sifter.",2/14/2013,"02/14/2013",3/20/2013,"03/20/2013"
"Food",64368,"Ongoing","Dakota Specialty Milling, Inc","Fargo","ND","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","AZ, AR, CA, GA, HI, IL, IN, KS, MA, MI, MN, MO, NY, ND, OH, PA, TN, TX, VA, WA, WI.","F-1125-2013","Class II","4060573 LOW MICRO. DARK RYE FLOUR (WHOLE RYE), DAKOTA SPECIALTY MILLING, INC., FARGO, ND, NET WT 50 LBS.","10291203 12111203",,"302.5000 CWTS","Some flour and flour blends produced at Dakota Specialty Milling have the potential to be contaminated with pliable metal wire mesh fragments from a defective flour sifter.",2/14/2013,"02/14/2013",3/20/2013,"03/20/2013"
"Food",64369,"Ongoing","Decoty Coffee Company, Inc","San Angelo","TX","US","Voluntary: Firm Initiated","Press Release","Mainly in TX but internet sales were nationwide.","F-1058-2013","Class I","Taco Seasoning, Net Wt. 1.25 lb and 5.75 lb. Distributed by Decoty Coffee Company, San Angelo, TX 76903, 800-588-8001. The products come in 1.25lb and 5.75lb sizes and are distributed in plastic spice containers with resealable lids.","The item code numbers are 71400 and 71410 with lot numbers from 010111 through 021313.",,"205 of the 1.25 lb and 310 of the 5.75 lb","DeCoty Coffee Company of San Angelo, Texas is recalling its 1.25lb and 5.75lb of DeCoty Taco Seasoning because it contains an undeclared ingredient, Soy. People who have an allergy or severe sensitivity to Soy run the risk of a life threatening or serious allergic reaction if they consume these items.",2/15/2013,"02/15/2013",3/13/2013,"03/13/2013"
"Devices",64370,"Ongoing","Animas Corporation","West Chester","PA","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution - USA (nationwide) including the states of: AL, AR, AZ, CA, CO, CT, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV and Puerto Rico and the countries of: Australia, Austria, Bermuda, Canada, Czech Republic, Finland, France, Germany, Ireland, Israel, Italy, Mexico, New Zealand, Norway, Spain and the United Kingdom.","Z-0993-2013","Class I","Animas(R) 2020 Insulin Infusion Pump Product Usage: This product is indicated for continuous subcutaneous infusion of insulin for the treatment of insulin-requiring diabetes. ","Part Numbers 101370-00, 101371-00, 101372-00, 101374-00, 101375-00, 100380-00, 100381-00, 100382-00, 100384-00, and 100385-00. Serial Numbers: 62-00202-12 36-97839-12 01-05118-12 25-02849-12 63-99894-12 80-00093-12 37-04692-12 92-04130-12 27-99281-12 32-99198-12 81-00513-12 44-02998-12 46-99680-12 23-02928-12 03-04500-12 01-03079-12 79-00261-12 26-99273-12 16-03650-12 93-03219-12 12-02808-12 21-04715-12 34-98485-12 40-98917-12 19-03646-12 27-00988-12 09-02900-12 28-99437-12 96-05032-12 03-00908-12 25-98448-12 15-02913-12 33-99713-12 91-00632-12 71-01130-12 07-05064-12 15-00948-12 92-02246-12 36-98399-12 97-00740-12 75-00229-12 32-01986-12 80-02118-12 97-04135-12 26-00899-12 20-03654-12 44-99495-12 31-99285-12 23-01970-12 43-99575-12 48-99499-12 83-00191-12 11-00768-12 31-99461-12 88-02066-12 88-00189-12 34-02974-12 24-02950-12 54-99790-12 96-03067-12 91-04122-12 74-00235-12 23-02759-12 96-04127-12 11-02652-12 44-99488-12 09-00766-12 23-03569-12 99-00580-12 20-02918-12 12-04178-12 06-05063-12 75-00243-12 29-02874-12 96-00549-12 75-00074-12 76-02114-12 03-00739-12 04-04237-12 76-03005-12 99-00559-12 01-03086-12 32-99374-12 97-03244-12 97-02346-12 90-02251-12 94-02343-12 43-99818-12 07-00838-12 19-02850-12 77-00083-12 90-02075-12 21-01961-12 88-04200-12 90-03061-12 10-00767-12 33-02885-12 16-98520-12 05-02294-12 70-00231-12 58-01001-12 34-04682-12 10-04190-12 64-00204-12 96-03081-12 35-02982-12 02-00488-12 18-98508-12 82-00088-12 01-00649-12 26-02938-12 22-04716-12 11-03624-12 14-98511-12 95-03066-12 28-98553-12 00-05029-12 95-05031-12 08-98403-12 36-02990-12 24-04718-12 03-02278-12 92-00707-12 20-02932-12 49-99933-12 10-99215-12 35-98567-12 36-97853-12 10-02394-12 03-02609-12 76-01054-12 77-00245-12 09-02555-12 00-02532-12 25-02944-12 06-00844-12 25-02782-12 19-02917-12 39-02898-12 37-99481-12 25-03754-12 95-02351-12 33-99449-12 78-00239-12 20-00879-12 22-98526-12 39-98916-12 33-98389-12 12-99224-12 52-99679-12 17-02908-12 51-99678-12 05-05055-12 26-04572-12 24-99271-12 25-02937-12 32-01979-12 83-00089-12 13-984",".","7,157 (494 US pumps affected)","Animas has identified a component issue affecting a small supply of the Animas(R) 2020 insulin pumps. The component issue may trigger the pumps to sound a false alarm or warning related to one of the following: - Loss of prime; -Occlusion; or -No cartridge detected. ",1/3/2013,"01/03/2013",4/10/2013,"04/10/2013"
"Veterinary",64371,"Ongoing","MI Industries Inc","Lincoln","NE","US","Voluntary: Firm Initiated","E-Mail","Distribution was made to AZ, CA, FL, IL, MI, MN, MO, NY, OH, PA, RI, TX, WA and Canada.","V-166-2013","Class I","Nature's Variety Instinct raw, Organic Chicken Formula medallions, packaged in 3-lb bags and packaged 9/3-lb bags/case. ","UPC # 7 69949 60137 1, 3-lb bag Best if Used By date of 10/04/13 UPC # 7 69949 70137 8, 27-lb case (9/3-lb bags/case) Best if Used By date of 10/04/13 ",,"658/9/3-lb bag/cases","The products may contain hard plastic pieces.",2/15/2013,"02/15/2013",5/22/2013,"05/22/2013"
"Veterinary",64371,"Ongoing","MI Industries Inc","Lincoln","NE","US","Voluntary: Firm Initiated","E-Mail","Distribution was made to AZ, CA, FL, IL, MI, MN, MO, NY, OH, PA, RI, TX, WA and Canada.","V-167-2013","Class I","Nature's Variety Instinct raw, Organic Chicken Formula patties, packaged in 6-lb bags and packaged in 6/6-lb bag/cases. ","UPC # 7 69949 60127 2, 6-lb bag Best if Used By date of 10/04/13 UPC # 7 69949 70127 9, 36-lb case (6/6-lb bags/case) Best if Used By date of 10/04/13 ",,"344/6/6-lb bag/cases","The products may contain hard plastic pieces.",2/15/2013,"02/15/2013",5/22/2013,"05/22/2013"
"Drugs",64372,"Ongoing","Novartis Consumer Health","Lincoln","NE","US","Voluntary: Firm Initiated","Letter","Nationwide and Puerto Rico, and Panama. Military distribution made.","D-576-2013","Class III","Lamisil AT Cream (terbinafine hydrochloride 1% antifungal), 12 gm ( .42 oz) Tubes and 30 gm (1 oz) Tubes packaged in one box, Novartis Consumer Health, Inc., Parsitan, NJ. UPC code: 300676249438. (Club Pack), NDC 0067-6295-43","Lot #: 10109590, 10111050, Exp 2/28/13.",".","41,400 Boxes","Labeling: Incorrect or Missing Lot and/or Expiration date; The Lot and/or Expiration date on the tube may not be legible in this lot.",2/19/2013,"02/19/2013",6/12/2013,"06/12/2013"
"Drugs",64372,"Ongoing","Novartis Consumer Health","Lincoln","NE","US","Voluntary: Firm Initiated","Letter","Nationwide and Puerto Rico, and Panama. Military distribution made.","D-574-2013","Class III","Target Up & Up, athlete's foot cream, full prescription strength, terbinafine hydrochloride 1% antifungal, 30 g (1 oz), compare to active ingredient in Lamisil, NDC 0067-6382-30 & UPC code: 300676382302 (Novartis) Target NDC 1167-3401-04, Distributed by Target Corp., Minneapolis, MN. ","Lot numbers and exp dates: 10108716 31-Mar-2013, 10111510 30-Apr-2013, 10113801 31-May-2013, 10113839 30-Apr-2013, 10115616 31-Aug-2013",".","99,660 tubes","Labeling: Incorrect or Missing Lot and/or Expiration date; The Lot and/or Expiration date on the tube may not be legible in this lot..",2/19/2013,"02/19/2013",6/12/2013,"06/12/2013"
"Drugs",64372,"Ongoing","Novartis Consumer Health","Lincoln","NE","US","Voluntary: Firm Initiated","Letter","Nationwide and Puerto Rico, and Panama. Military distribution made.","D-575-2013","Class III","Novartis Lamisil AT Cream for Jock Itch (terbinafine hydrochloride 1% antifungal), a) 12 g (.42 oz) Tube, NDC 0067-3999-12, Novartis Consumer Health, Inc., Parsitan, NJ. UPC code: 300673999121, (Vertical Pack) and b) packaged in a horizontal package12 gm (.42 oz) Tube, NDC 0067-3999-42, Novartis Consumer Health, Inc., Parsippany, NJ. UPC code: 300673999428.","Lot number and exp date: 10104145 30-Apr-2013. (Vertical package) and Lot number and exp date: 10109587 30-Apr-2013, 10111508 31-May-2013; 10119095 31-Jul-2013 and 10119096 30-Sep-2013 (Horizontal package).",".","219,600 tubes","The products have illegible lot and/or expiration dates on the product container.",2/19/2013,"02/19/2013",6/12/2013,"06/12/2013"
"Drugs",64372,"Ongoing","Novartis Consumer Health","Lincoln","NE","US","Voluntary: Firm Initiated","Letter","Nationwide and Puerto Rico, and Panama. Military distribution made.","D-577-2013","Class III","Voltaren Gel (diclofenac sodium topical gel) 1%, for topical use only, RX only, a) Packaged in 20 gm tubes, NDC 63481-684-83 (physician sample product) and b) 100 gm tubes, NDC 63481-684-47 (the 100 g tubes are also packaged 3/100-g tubes/packs (UPC code: 363481684030 NDC code: 6348168403) and 5/100-g tubes/packs (UPC code: 363481684054 NDC code: 6348168405), Marketed by Endo Pharmaceuticals Inc., Chadds Ford, PA and Manufactured by Novartis Consumer Health, Inc, Parsippany, NJ. ","Lot #'s and Expiration dates: a) 20 gm tubes: 10116298 05/31/14 10116299 05/31/14 10116300 05/31/14 10117402 07/31/14 10117403 07/31/14 10117404 08/31/14 10117405 08/31/14 10117406 08/31/14 10117407 10/31/14 10117408 10/31/14 b) 100 gm tubes: 10119436 10119436 10119437 10119437 10119438 10119438 10119439 10119439 10119440 10119440 10119441 10119441 10119442 10119442 10119443 10119443 10119444 10119444 10119445 10119445 10119446 10119446 100 gm/3 pack: 10085217 2/28/2013 10085218 2/28/2013 10085219 2/28/2013 10085220 2/28/2013 10085221 2/28/2013 10085222 2/28/2013 10085223 2/28/2013 10085224 2/28/2013 10085225 2/28/2013 10085226 2/28/2013 10085227 2/28/2013 10085228 2/28/2013 10085229 2/28/2013 10085230 2/28/2013 10085231 2/28/2013 10085232 2/28/2013 10085233 2/28/2013 10085234 2/28/2013 10085235 2/28/2013 10085236 2/28/2013 10085238 2/28/2013 10085239 2/28/2013 10085240 2/28/2013 10085241 2/28/2013 10085242 2/28/2013 10085243 2/28/2013 10085244 2/28/2013 10085245 2/28/2013 10085246 3/31/2013 10085247 3/31/2013 10085248 3/31/2013 10085249 3/31/2013 10085260 3/31/2013 10085261 3/31/2013 10085262 3/31/2013 10085263 3/31/2013 10085264 3/31/2013 10085265 3/31/2013 10085266 3/31/2013 10085267 3/31/2013 10085268 3/31/2013 10085269 3/31/2013 10085270 3/31/2013 10085271 3/31/2013 10085272 3/31/2013 10087039 3/31/2013 10087040 3/31/2013 10087041 3/31/2013 10087042 3/31/2013 10087043 3/31/2013 10087052 3/31/2013 10087053 3/31/2013 10087054 3/31/2013 10087055 3/31/2013 10087063 3/31/2013 10087064 3/31/2013 10087065 3/31/2013 10088276 4/30/2013 10088277 4/30/2013 10088278 4/30/2013 10088279 4/30/2013 10088280 4/30/2013 10088281 4/30/2013 10088282 4/30/2013 10088289 4/30/2013 10088290 4/30/2013 10088291 4/30/2013 10088292 4/30/2013 10088293 4/30/2013 10088294 4/30/2013 10088295 4/30/2013 10088296 4/30/2013 10088297 4/30/2013 10088298 4/30/2013 10088299 4/30/2013 10088300 4/30/2013 10088301 4/30/2013 10088302 4/30/2013 10088303 4/30/2013 10088304 4/30/2013 10088305 4/30/2013 10088306 4/30/2013 10088307 4/30/2013 10088308 4/3",".","a) 1,043,926 (20-gm) tubes and b) 3,385,481 (100-gm) tubes","Labeling: Incorrect or Missing Lot and/or Expiration date; The Lot and/or Expiration date on the tube may not be legible in this lot.",2/19/2013,"02/19/2013",6/12/2013,"06/12/2013"
"Drugs",64372,"Ongoing","Novartis Consumer Health","Lincoln","NE","US","Voluntary: Firm Initiated","Letter","Nationwide and Puerto Rico, and Panama. Military distribution made.","D-573-2013","Class III","Novartis Lamisil AT Cream, Terbinafine Hydrochloride Cream 1% Antifungal, Novartis Consumer Health, Inc., Parsippany, NJ. (a)12 gm (.42 oz), packaged with UPC code 300673998421 and NDC code: 0067-3998-42; (b) 12 gm (.42 oz), packaged with UPC code: 300673998124 and NDC code: 0067-3998-12; (c) 30 gm (1 oz), packaged with UPC code: 300673998308 and NDC code: 0067-3998-30; (d) 30 gm (1 oz), packaged with UPC code: 300673998339 and NDC code: 0067-3998-33.","(12 gm) Lot numbers and Exp dates: 10109586 30-Apr-2013, 10116816 31 May 2013, 10117695 31-Jul-2013, 10120283 31-Aug-2013, 10104980 28-Feb-2013, 10108711 31-Mar-2013, 10111313 30-Apr-2013, 10111509 30-Apr-2013, 10115506 30-Jun-2013, 10117696 30-Jun-2013, 10120763 31-Aug-2013, 10122695 30-Sep-2013, 10104983 28-Feb-2013, 10108714 31-Mar-2013, 10119643 31-Jul-2013 (30 gm) Lot numbers and Exp dates: 10104979 28-Feb-2013 10108712 31-Mar-2013 10109588 30-Apr-2013 10111507 30-Apr-2013 10115133 31-May-2013 10115619 30-Jun-2013 10117694 31-Aug-2013 10120762 30-Sep-2013 10109981 31-Mar-2013 10111316 31-Mar-2013 10114223 31-May-2013 10117697 30-Jun-2013 10104982 28-Feb-2013 10108355 31-Mar-2013, 10112072 30-Apr-2013, 10112073 30-Apr-2013 10113501 31-May-2013, 10122772 31-Aug-2013 ",".","818,064 (12-gm) tubes and 836,376 (30-gm) tubes ","Labeling: Incorrect or Missing Lot and/or Expiration date; The Lot and/or Expiration date on the tube may not be legible in this lot.",2/19/2013,"02/19/2013",6/12/2013,"06/12/2013"
"Biologics",64373,"Terminated","University Of Miami Miller School of Medicine Tissue Bank","Miami","FL","US","Voluntary: Firm Initiated","Letter","Michigan; Nebraska; Florida; California; Kentucky","B-1132-13","Class III","Tendon","UBI009136012610; UBI009136012710; UBI009136012810; UBI009136012910; UBI009136013110; UBI009136013210; UBI009136013310; UBI009136013410",,"8","HCT/P allografts, mislabeled with an incorrect expiration date, were distributed. ",12/22/2010,"12/22/2010",4/3/2013,"04/03/2013"
"Biologics",64374,"Terminated","University Of Miami Miller School of Medicine Tissue Bank","Miami","FL","US","Voluntary: Firm Initiated","Letter","Michigan; Kansas; Florida; Texas","B-1130-13","Class III","Bone","UBO005935003010; UBO005935003110; UBO005935003210; UBO005935003310; UBO005935003410; UBO005935003510",,"6","HCT/P allografts, mislabeled with an incorrect expiration date, were distributed. ",11/9/2010,"11/09/2010",4/3/2013,"04/03/2013"
"Biologics",64375,"Terminated","Coastal Bend Blood Center","Corpus Christi","TX","US","Voluntary: Firm Initiated","FAX","Austria; Texas","B-1194-13","Class II","Red Blood Cells Leukocytes Reduced","W230811203265; ",,"1","Blood products, which were not quarantined subsequent to receiving information regarding donor's deferral status, were distributed.",2/4/2013,"02/04/2013",5/22/2013,"05/22/2013"
"Biologics",64375,"Terminated","Coastal Bend Blood Center","Corpus Christi","TX","US","Voluntary: Firm Initiated","FAX","Austria; Texas","B-1195-13","Class II","Blood and Blood Products for Reprocessing","W230811203265; ",,"1","Blood products, which were not quarantined subsequent to receiving information regarding donor's deferral status, were distributed.",2/4/2013,"02/04/2013",5/22/2013,"05/22/2013"
"Devices",64376,"Ongoing","Siemens Medical Solutions USA, Inc","Malvern","PA","US","Voluntary: Firm Initiated","Letter","Nationwide Distribution.","Z-0948-2013","Class II","Siemens Somatom CT's equipped with software syngo CT2010A, syngo CT2010B, syngo CT2011A and CT2012B. Computed tomography x-ray system. ","Model numbers - 7740769, 8098027, 10430603, and 10590000.",,"896","Sporadic hang-up malfunctions concerning 3D reconstructions during activated ''Preview Image'' functionality.",11/27/2012,"11/27/2012",3/20/2013,"03/20/2013"
"Biologics",64377,"Terminated","Lifesouth Community Blood Centers, Inc. - Mobile Region","Mobile","AL","US","Voluntary: Firm Initiated","FAX","Alabama","B-1272-13","Class II","Platelets Pheresis Leukocytes Reduced","W115112335533G; ",".","1","Blood product, which did not meet acceptable product specifications, was distributed.",12/11/2012,"12/11/2012",6/12/2013,"06/12/2013"
"Biologics",64378,"Terminated","LifeSouth Community Blood Centers, Inc.","Gainesville","FL","US","Voluntary: Firm Initiated","FAX","Florida","B-1273-13","Class II","Platelets Pheresis Leukocytes Reduced Irradiated","W1151130013868; ",".","1","Blood product, which did not meet acceptable product specifications, was distributed.",12/19/2012,"12/19/2012",6/12/2013,"06/12/2013"
"Biologics",64379,"Terminated","LifeShare Blood Centers","Shreveport","LA","US","Voluntary: Firm Initiated","FAX","Louisiana","B-1274-13","Class III","Fresh Frozen Plasma (Apheresis)","W036512123500; W036512123495; ",".","2","Blood products, labeled with an incorrect expiration dates, were distributed.",1/4/2013,"01/04/2013",6/12/2013,"06/12/2013"
"Biologics",64379,"Terminated","LifeShare Blood Centers","Shreveport","LA","US","Voluntary: Firm Initiated","FAX","Louisiana","B-1275-13","Class II","Platelets Pheresis Leukocytes Reduced","W036512123499; W036512123500; W036512123495; W036512123497; W036512123795; W036512123796; W036512123792; W036512123792; W036512123793; W036512123793; W036512123794; W036512123499; ",".","12","Blood products, labeled with an incorrect expiration dates, were distributed.",1/4/2013,"01/04/2013",6/12/2013,"06/12/2013"
"Biologics",64380,"Terminated","Mississippi Blood Services Inc.","Flowood","MS","US","Voluntary: Firm Initiated","FAX","Mississippi","B-1179-13","Class II","Red Blood Cells Leukocytes Reduced","W069112127383; ",".","1","Blood product, collected from a donor who reported living in a malarial endemic area within the past three years, was distributed.",12/19/2012,"12/19/2012",6/19/2013,"06/19/2013"
"Biologics",64381,"Terminated","Upstate New York Transplant Services","Buffalo","NY","US","Voluntary: Firm Initiated","FAX","New York","B-1180-13","Class II","Red Blood Cells Leukocytes Reduced","W280312101666; ",".","1","Blood product, collected from a donor who reported living in a malarial endemic area within the past three years, was distributed.",1/16/2013,"01/16/2013",6/19/2013,"06/19/2013"
"Devices",64383,"Ongoing","Salyer Prn Biomedical","Mesa","AZ","US","Voluntary: Firm Initiated","Letter","Distributed in the states of MA,CA, and WI.","Z-0902-2013","Class II","Century Console Base, Model #043625051b Intended for use as a platform for other ancillary equipment and disposable products in cardiopulmonary surgical procedures.","Serial Numbers: CCB40120, CCB40121, CCB40122, CCB40123, CCB40124, CCB40139, CCB40140, CCB40143, and CCB40144.",,"9 units","Concerns that the addition of the UPS Battery Backup to the Century Console Base Shelf did not comply with the FDA premarket notification regulations.",1/31/2013,"01/31/2013",3/13/2013,"03/13/2013"
"Food",64384,"Ongoing","Koda Farms Inc","South Dos Palos","CA","US","Voluntary: Firm Initiated","Telephone","CA and HI","F-1022-2013","Class II","Mochiko Blue Star Sweet Rice Flour;Net Wt. 50 lbs. (22.68 k) Koda Farms Milling, Inc. South Dos Palos, CA 93665","Product code 3F13 and 3F14 (produced January 13 and 1, 2013.",,"878 x 50 lb. bags.","Koda Farms received a report from a customer that a hard yellow material was found in rice flour dough that had been manufactured using rice flour supplied by Koda Farms. The rice flour is believed to be the source of the foreign object.",2/15/2013,"02/15/2013",3/6/2013,"03/06/2013"
"Food",64385,"Ongoing","Buffalo Trace Distillery","Frankfort","KY","US","Voluntary: Firm Initiated","Letter","Product was distributed to the following states: AL, AZ, CA, CO, GA, IL, IN, KS, KY, LA, MD, MI, MO, NC, NE, NJ, NV, NY, OK, PA, SD, TN, TX, VA, WA, WI & WV. Product was also shipped to Canada and the United Kingdom.","F-1372-2013","Class I","BUFFALO TRACE BOURBON FLAVORED CARAMEL SAUCE 8 oz glass jars Net Wt. 8 fl. oz./227 g, PRODUCED BY: APPLECREEK ORCHARDS LLC P.O. Box 8383 Lexington, KY 40533 BUFFALO TRACE DISTILLERY 113 Great Buffalo Trace Franklin County Frankfort, KY 40601 800-654-8471 e-mail: greatboubon@buffalotrace.com website: www.buffalotrace.com UPC 7 95436 00105 8 Best By 2/16/14","Best By 2/16/14",,"1,504/8 fl. oz. jars","The firm failed to include allergen milk on the label of this sauce.",2/5/2013,"02/05/2013",5/8/2013,"05/08/2013"
"Food",64385,"Ongoing","Buffalo Trace Distillery","Frankfort","KY","US","Voluntary: Firm Initiated","Letter","Product was distributed to the following states: AL, AZ, CA, CO, GA, IL, IN, KS, KY, LA, MD, MI, MO, NC, NE, NJ, NV, NY, OK, PA, SD, TN, TX, VA, WA, WI & WV. Product was also shipped to Canada and the United Kingdom.","F-1374-2013","Class I","BUFFALO TRACE MARINADE FOR MEAT Net Wt. 12 fl. oz. PRODUCED BY: APPLECREEK ORCHARDS LLC P.O. Box 8383 Lexington, KY 40533 BUFFALO TRACE DISTILLERY 113 Great Buffalo Trace Franklin County Frankfort, KY 40601 800-654-8471 e-mail: greatboubon@buffalotrace.com website: www.buffalotrace.com UPC 7 95436 00107 2 Best By 10/30/14","Beset By 10/30/14",,"993/12 fl. oz. bottles","The firm failed to include allergens of wheat and anchovy on the label of this marinade. Soy sauce is listed, but soy is not listed as the source of the sauce.",2/5/2013,"02/05/2013",5/8/2013,"05/08/2013"
"Food",64385,"Ongoing","Buffalo Trace Distillery","Frankfort","KY","US","Voluntary: Firm Initiated","Letter","Product was distributed to the following states: AL, AZ, CA, CO, GA, IL, IN, KS, KY, LA, MD, MI, MO, NC, NE, NJ, NV, NY, OK, PA, SD, TN, TX, VA, WA, WI & WV. Product was also shipped to Canada and the United Kingdom.","F-1375-2013","Class I","BUFFALO TRACE ORIGINAL FLAVOR BARBEQUE SAUCE Net Wt. 16 fl. oz./532 ml PRODUCED BY: APPLECREEK ORCHARDS LLC P.O. Box 8383 Lexington, KY 40533 BUFFALO TRACE DISTILLERY 113 Great Buffalo Trace Franklin County Frankfort, KY 40601 800-654-8471 e-mail: greatboubon@buffalotrace.com website: www.buffalotrace.com UPC 7 95436 00106 5 Best By 1/19/15","Best By 1/19/15",,"1,658/16 fl. oz. jar","The firm failed to include allergens of soy and anchovy on the label of this sauce.",2/5/2013,"02/05/2013",5/8/2013,"05/08/2013"
"Food",64385,"Ongoing","Buffalo Trace Distillery","Frankfort","KY","US","Voluntary: Firm Initiated","Letter","Product was distributed to the following states: AL, AZ, CA, CO, GA, IL, IN, KS, KY, LA, MD, MI, MO, NC, NE, NJ, NV, NY, OK, PA, SD, TN, TX, VA, WA, WI & WV. Product was also shipped to Canada and the United Kingdom.","F-1376-2013","Class I","BUFFALO TRACE HOT BARBEQUE SAUCE Net Wt. 16 fl. oz./532 ml PRODUCED BY: APPLECREEK ORCHARDS LLC P.O. Box 8383 Lexington, KY 40533 BUFFALO TRACE DISTILLERY 113 Great Buffalo Trace Franklin County Frankfort, KY 40601 800-654-8471 e-mail: greatboubon@buffalotrace.com website: www.buffalotrace.com UPC 7 95436 00017 4 Best By 11/7/14","Best By 11/7/14",,"635/16 fl. oz. jars","The firm failed to include allergens of soy and anchovy on the labels of this sauce.",2/5/2013,"02/05/2013",5/8/2013,"05/08/2013"
"Food",64385,"Ongoing","Buffalo Trace Distillery","Frankfort","KY","US","Voluntary: Firm Initiated","Letter","Product was distributed to the following states: AL, AZ, CA, CO, GA, IL, IN, KS, KY, LA, MD, MI, MO, NC, NE, NJ, NV, NY, OK, PA, SD, TN, TX, VA, WA, WI & WV. Product was also shipped to Canada and the United Kingdom.","F-1373-2013","Class I","BUFFALO TRACE BOURBON FUDGE SAUCE 8 oz glass jars Net Wt. 8 fl. oz./227 g, PRODUCED BY: APPLECREEK ORCHARDS LLC P.O. Box 8383 Lexington, KY 40533 BUFFALO TRACE DISTILLERY 113 Great Buffalo Trace Franklin County Frankfort, KY 40601 800-654-8471 e-mail: greatboubon@buffalotrace.com website: www.buffalotrace.com UPC 7 95436 00103 4 Best By 1/30/14","Best By 1/30/14",,"1,686/8 fl. oz. jars","The firm failed to include allergens of milk and soy on the label of this sauce.",2/5/2013,"02/05/2013",5/8/2013,"05/08/2013"
"Devices",64386,"Ongoing","Horiba Instruments, Inc dba Horiba Medical","Irvine","CA","US","Voluntary: Firm Initiated","Letter","Nationwide Distribution","Z-1050-2013","Class III","ABX Micros IM2, Part# M60CSB110EN04 and D00A00202 The IM2 Data Management System consists of the IM2 Data Manager Software, Desktop Computer, keyboard, mouse, and a unidirectional serial cable. The IM2 software is used to store, retrieve, and process laboratory data received via a unidirectional serial connection from the ABX Micros 60. ","All serial numbers",".","180 units","Horiba Medical is recalling ABX Micros IM2 Data Management System because it may display incorrect patient test results under unanticipated operating conditions.",2/15/2013,"02/15/2013",4/10/2013,"04/10/2013"
"Biologics",64387,"Ongoing","Immucor Inc","Norcross","GA","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Nationwide, Canada, Columbia, England, Germany, Japan, Norway, Peru, South Africa, and South Korea.","B-1096-13","Class III","WB corQC 4.5 mL vials","Lots 236154, 236154A, Exp. Date 2013-02-07",,"2","Immucor WB corQC, associated with complaints of hemolysis, was distributed. ",2/12/2013,"02/12/2013",3/20/2013,"03/20/2013"
"Drugs",64388,"Ongoing","L. Perrigo Co.","Allegan","MI","US","Voluntary: Firm Initiated","Letter","Walmart Distribution Center in Bentonville, AR","D-216-2013","Class III","PE Daytime Cold/Flu LiqGel, Multi Symptom Relief, Acetaminophen/Dextromethorphan HBr/Phenylephrine HCL 325/10/5 mg gel caps 20 count blister pack, Distributed By: Wal-Mat Stores Inc., Bentonville, AR, 72716 "," 2 AE1549 Exp. 02/13",,"60,048 Blister packs","Failed Stability Specifications: The product had a stability failure at the 12 month time point for the active ingredient Phenylephrine HCL.",2/18/2013,"02/18/2013",4/3/2013,"04/03/2013"
"Devices",64389,"Ongoing","Philips Medical Systems (Cleveland) Inc","Cleveland","OH","US",,,"Worldwide Distribution - USA including AL, AR, CA, FL, GA, IL, IN, KY, MI, MS, NC, NJ, NV, NY, OH, PA, PR and VA.","Z-0899-2013","Class II","The MX 16-Slice CT Scanner System can be used as a whole-body computed tomography X-ray system featuring a continuously rotating X-ray tube and detector array with multi-slice capability up to 16 slices simultaneously.","System Code #, 728131, Serial #: EP16E090001, EP16E090002, EP16E090003, EP16E090004, EP16E090006, EP16E090007, EP16E090008, EP16E090009, EP16E090010, EP16E090011, EP16E090012,EP16E090013, EP16E090015, EP16E100001, EP16E100004, EP16E100006, EP16E100008, EP16E100010, EP16E100011, EP16E100012, EP16E100013, EP16E100015, EP16E100016, EP16E100017, EP16E100018, EP16E100019, EP16E100020, EP16E100021, EP16E100022, EP16E100023, EP16E100024, EP16E100025, EP16E100026, EP16E100027, EP16E100028, EP16E100029, EP16E100030, EP16E100031, EP16E100032, EP16E100033, EP16E100034, EP16E100035, EP16E100036, EP16E100037, EP16E100038, EP16E100039, EP16E100041, EP16E100043, EP16E100044, EP16E100045, EP16E100046, EP16E100047, EP16E100048, EP16E100049, EP16E100051, EP16E100052, EP16E100055, EP16E100056, EP16E100057, EP16E100058, EP16E100059, EP16E100060, EP16E100061, EP16E100062, EP16E100063, EP16E100067, EP16E100069, EP16E100070, EP16E100071, EP16E100072, EP16E100073, EP16E100074, EP16E100075, EP16E100076, EP16E100077, EP16E100078, EP16E100079, EP16E100080, EP16E100081, EP16E100082, EP16E100083, EP16E100084, EP16E100085, EP16E100086, EP16E100087, EP16E100088, EP16E100090, EP16E100091, EP16E100092, EP16E100093, EP16E100094, EP16E100095, EP16E100096, EP16E100099, EP16E100100, EP16E100101, EP16E100102, EP16E100103, EP16E100105, EP16E100106, EP16E100107, EP16E100108, EP16E100109, EP16E100110, EP16E100111, EP16E100112, EP16E100113, EP16E110003, EP16E110005, EP16E110006, EP16E110007, EP16E110008, EP16E110009, EP16E110011, EP16E110012, EP16E110013, EP16E110014, EP16E110015, EP16E110017, EP16E110018, EP16E110019, EP16E110020, EP16E110021, EP16E110023, EP16E110024, EP16E110025, EP16E110026, EP16E110027, EP16E110028, EP16E110029, EP16E110030, EP16E110031, EP16E110032, EP16E110033, EP16E110034, EP16E110035, EP16E110037, EP16E110038, EP16E110039, EP16E110042, EP16E110043, EP16E110044, EP16E110045, EP16E110046, EP16E110047, EP16E110048, EP16E110049, EP16E110050, EP16E110051, EP16E110052, EP16E110054, EP16E110055, EP16E110056, EP16E110057, EP16E110058",,"412 Units","Philips and Neusoft Medical Systems Co., Ltd. received a report from the field stating the four screws that secure the patient table top to the carrier became loose, which caused the table top to detach.",12/19/2012,"12/19/2012",3/6/2013,"03/06/2013"
"Devices",64390,"Ongoing","Heartware Inc","Miami Lakes","FL","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution-USA (nationwide) including the states of MN, IL, MI, FL, WI, TX, MO, CA, MA, TN, OH, NC, GA, VA, UT, KY, MD, IN, PA, NY, NJ, LA, OR, WA, AL and CO, and the countries of Poland, Australia, Austria, Italy, Germany, New Zealand, South Africa, Czech Republic, France, Brazil, Switzerland, Singapore, United Kingdom, Saudi Arabia, Netherlands, China, Chile, Belgium, Canada, Norway, Lebanon, Israel, Malaysia, Turkey, India, Argentina, Greece, Japan and Lithuania.","Z-1323-2013","Class II","REF 1103***HVAD Pump Implant Kit. Used as a bridge-to-cardiac transplantation in patients who are at risk of death from refractory end-stage left ventricular heart failure.","Serial Numbers: United States: HW001-HW3827 and International: HW001-HW3827 and HW1000-HW10675",,"3,544","HeartWare, Inc. of Miami Lakes, FL is recalling their Ventricular Assist System due to the loosening of the HVAD Pump driveline connector.",12/27/2012,"12/27/2012",5/22/2013,"05/22/2013"
"Veterinary",64392,"Ongoing","Kasel Associates Industries, Inc.","Denver","CO","US","Voluntary: Firm Initiated","Telephone","Nationwide distribution.","V-245-2013","Class I","Boots & Barkley American Smoked Beef Femur Bone 3 inch. Satisfies your dog's instinctive urge to chew. Ingredients: Beef Femur Bone. Distributed by TARGET Corporation, Minneapolis, MN 55403, 2012 Target Brands, Inc. Made in U.S.A. Packaging is transparent with white, blue and red with red, black and blue print writing on the affixed label, UPC 085239403495.","Best By dates of 20APR2014 DEN to 03OCT2014 DEN.",,"46,080 bags","Kasel Industries received a 423(a), Notification of Opportunity to Initiate a Voluntary Recall, letter from FDA and is recalling all lots of pet treats manufactured at their facility between April 20, 2012 and September 19, 2012 due to positive Salmonella findings in the firm's products and facility. ",2/19/2013,"02/19/2013",7/31/2013,"07/31/2013"
"Veterinary",64392,"Ongoing","Kasel Associates Industries, Inc.","Denver","CO","US","Voluntary: Firm Initiated","Telephone","Nationwide distribution.","V-282-2013","Class I","K9 Chicken Coat Jerky 5oz; UPC 669125507063; 15oz, UPC 669125507070","Best By dates of 04202014 DEN to 10032014 DEN.",,"2000 - 5oz bags; 3600 - 15 oz bags","Kasel Industries received a 423(a), Notification of Opportunity to Initiate a Voluntary Recall, letter from FDA and is recalling all lots of pet treats manufactured at their facility between April 20, 2012 and September 19, 2012 due to positive Salmonella findings in the firm's products and facility. ",2/19/2013,"02/19/2013",7/31/2013,"07/31/2013"
"Veterinary",64392,"Ongoing","Kasel Associates Industries, Inc.","Denver","CO","US","Voluntary: Firm Initiated","Telephone","Nationwide distribution.","V-280-2013","Class I","Nutri-Pet 16oz Natural Filet Strips, UPC 76-0081.","Best By dates of 04202014 DEN to 10032014 DEN.",,"2016 bags","Kasel Industries received a 423(a), Notification of Opportunity to Initiate a Voluntary Recall, letter from FDA and is recalling all lots of pet treats manufactured at their facility between April 20, 2012 and September 19, 2012 due to positive Salmonella findings in the firm's products and facility. ",2/19/2013,"02/19/2013",7/31/2013,"07/31/2013"
"Veterinary",64392,"Ongoing","Kasel Associates Industries, Inc.","Denver","CO","US","Voluntary: Firm Initiated","Telephone","Nationwide distribution.","V-284-2013","Class I","K9 Chicken Breath Fresh Jerky 5oz, UPC 669125507100 ; 15oz , UPC 669125507117","Best By dates of 04202014 DEN to 10032014 DEN.",,"2000 - 5 oz bags; 3600 - 15 oz bags","Kasel Industries received a 423(a), Notification of Opportunity to Initiate a Voluntary Recall, letter from FDA and is recalling all lots of pet treats manufactured at their facility between April 20, 2012 and September 19, 2012 due to positive Salmonella findings in the firm's products and facility. ",2/19/2013,"02/19/2013",7/31/2013,"07/31/2013"
"Veterinary",64392,"Ongoing","Kasel Associates Industries, Inc.","Denver","CO","US","Voluntary: Firm Initiated","Telephone","Nationwide distribution.","V-264-2013","Class I","Colorado Naturals Chicken Chips, 16 oz, UPC 647263800291, Distributed by Petco/Kasel Ind.","Best By dates of 04202014 DEN to 10032014 DEN.",,"39,648 - 16oz bags","Kasel Industries received a 423(a), Notification of Opportunity to Initiate a Voluntary Recall, letter from FDA and is recalling all lots of pet treats manufactured at their facility between April 20, 2012 and September 19, 2012 due to positive Salmonella findings in the firm's products and facility. ",2/19/2013,"02/19/2013",7/31/2013,"07/31/2013"
"Veterinary",64392,"Ongoing","Kasel Associates Industries, Inc.","Denver","CO","US","Voluntary: Firm Initiated","Telephone","Nationwide distribution.","V-273-2013","Class I","TDBBS, Inc/Best Bully Sticks Chicken Jerky, 16 oz.","Best By dates of 04202014 DEN to 10032014 DEN.",,"4000 bags","Kasel Industries received a 423(a), Notification of Opportunity to Initiate a Voluntary Recall, letter from FDA and is recalling all lots of pet treats manufactured at their facility between April 20, 2012 and September 19, 2012 due to positive Salmonella findings in the firm's products and facility. ",2/19/2013,"02/19/2013",7/31/2013,"07/31/2013"
"Veterinary",64392,"Ongoing","Kasel Associates Industries, Inc.","Denver","CO","US","Voluntary: Firm Initiated","Telephone","Nationwide distribution.","V-248-2013","Class I","Boots & Barkley Chicken Stuffed American Beef Femur Bone, 6 inch. Satisfies your dog's instinctive urge to chew. Ingredients: Beef Femur Bone Chicken Breast, Natural Flavorings. Distributed by TARGET Corporation, Minneapolis, MN 55403, 2012 Target Brands, Inc. Made in U.S.A. Packaging is transparent with white, blue and red with red, black and blue print writing on the affixed label, UPC 085239043202.","Best By dates of 20APR2014 DEN to 03OCT2014 DEN.",,"42336 bags","Kasel Industries received a 423(a), Notification of Opportunity to Initiate a Voluntary Recall, letter from FDA and is recalling all lots of pet treats manufactured at their facility between April 20, 2012 and September 19, 2012 due to positive Salmonella findings in the firm's products and facility. ",2/19/2013,"02/19/2013",7/31/2013,"07/31/2013"
"Veterinary",64392,"Ongoing","Kasel Associates Industries, Inc.","Denver","CO","US","Voluntary: Firm Initiated","Telephone","Nationwide distribution.","V-286-2013","Class I","K9 Chicken Digestive Jerky 5oz, UPC 669125507148.","Best By dates of 04202014 DEN to 10032014 DEN.",,"2000 - 5 oz bags","Kasel Industries received a 423(a), Notification of Opportunity to Initiate a Voluntary Recall, letter from FDA and is recalling all lots of pet treats manufactured at their facility between April 20, 2012 and September 19, 2012 due to positive Salmonella findings in the firm's products and facility. ",2/19/2013,"02/19/2013",7/31/2013,"07/31/2013"
"Veterinary",64392,"Ongoing","Kasel Associates Industries, Inc.","Denver","CO","US","Voluntary: Firm Initiated","Telephone","Nationwide distribution.","V-279-2013","Class I","TDBBS, Inc/Best Bully Sticks Lamb Jerky, 4 oz.","Best By dates of 04202014 DEN to 10032014 DEN.",,"200 bags","Kasel Industries received a 423(a), Notification of Opportunity to Initiate a Voluntary Recall, letter from FDA and is recalling all lots of pet treats manufactured at their facility between April 20, 2012 and September 19, 2012 due to positive Salmonella findings in the firm's products and facility. ",2/19/2013,"02/19/2013",7/31/2013,"07/31/2013"
"Veterinary",64392,"Ongoing","Kasel Associates Industries, Inc.","Denver","CO","US","Voluntary: Firm Initiated","Telephone","Nationwide distribution.","V-289-2013","Class I","K9 Hip & Joint Chicken Strips 8oz, UPC 669125990445","Best By dates of 04202014 DEN to 10032014 DEN",,"1728 bags","Kasel Industries received a 423(a), Notification of Opportunity to Initiate a Voluntary Recall, letter from FDA and is recalling all lots of pet treats manufactured at their facility between April 20, 2012 and September 19, 2012 due to positive Salmonella findings in the firm's products and facility. ",2/19/2013,"02/19/2013",7/31/2013,"07/31/2013"
"Veterinary",64392,"Ongoing","Kasel Associates Industries, Inc.","Denver","CO","US","Voluntary: Firm Initiated","Telephone","Nationwide distribution.","V-261-2013","Class I","Sam's Club Roasted Pig Ear Dog Treats, 28 oz, UPC 681131857246.","Best By dates of 04202014 DEN to 10032014 DEN.",,"28,224 - 25ct bags","Kasel Industries received a 423(a), Notification of Opportunity to Initiate a Voluntary Recall, letter from FDA and is recalling all lots of pet treats manufactured at their facility between April 20, 2012 and September 19, 2012 due to positive Salmonella findings in the firm's products and facility. ",2/19/2013,"02/19/2013",7/31/2013,"07/31/2013"
"Veterinary",64392,"Ongoing","Kasel Associates Industries, Inc.","Denver","CO","US","Voluntary: Firm Initiated","Telephone","Nationwide distribution.","V-252-2013","Class I","Boots & Barkley American Pork Femur, 1 bone. Promotes Plaque and Tartar Reduction. Ingredients: Pork Femur. Distributed by TARGET Corporation, Minneapolis, MN 55403, 2012 Target Brands, Inc. Packaging is semi-transparent with white, blue and red with red, black and blue print writing on the affixed label. The labeling also has digital photo of a dog. UPC 647263899165.","Best By dates of 20APR2014 DEN to 03OCT2014 DEN.",,"135360 bags","Kasel Industries received a 423(a), Notification of Opportunity to Initiate a Voluntary Recall, letter from FDA and is recalling all lots of pet treats manufactured at their facility between April 20, 2012 and September 19, 2012 due to positive Salmonella findings in the firm's products and facility. ",2/19/2013,"02/19/2013",7/31/2013,"07/31/2013"
"Veterinary",64392,"Ongoing","Kasel Associates Industries, Inc.","Denver","CO","US","Voluntary: Firm Initiated","Telephone","Nationwide distribution.","V-283-2013","Class I","K9 Chicken Calming Jerky 5oz, UPC 669125507087 ; 15oz , UPC 669125507094 ","Best By dates of 04202014 DEN to 10032014 DEN.",,"2000 - 5 oz bags; 3600 - 15 oz bags","Kasel Industries received a 423(a), Notification of Opportunity to Initiate a Voluntary Recall, letter from FDA and is recalling all lots of pet treats manufactured at their facility between April 20, 2012 and September 19, 2012 due to positive Salmonella findings in the firm's products and facility. ",2/19/2013,"02/19/2013",7/31/2013,"07/31/2013"
"Veterinary",64392,"Ongoing","Kasel Associates Industries, Inc.","Denver","CO","US","Voluntary: Firm Initiated","Telephone","Nationwide distribution.","V-263-2013","Class I","Petco Smoked Pig Ears, 7 pk, UPC 800443092941, 12 pk UPC 800443092927.","Best By dates of 04202014 DEN to 10032014 DEN.",,"5,376 - 12ct bags; 4,704 - 7ct bags","Kasel Industries received a 423(a), Notification of Opportunity to Initiate a Voluntary Recall, letter from FDA and is recalling all lots of pet treats manufactured at their facility between April 20, 2012 and September 19, 2012 due to positive Salmonella findings in the firm's products and facility. ",2/19/2013,"02/19/2013",7/31/2013,"07/31/2013"
"Veterinary",64392,"Ongoing","Kasel Associates Industries, Inc.","Denver","CO","US","Voluntary: Firm Initiated","Telephone","Nationwide distribution.","V-255-2013","Class I","BIXBI Hip and Joint Pork Jerky, 5 oz. Packaged in yellow and aqua semi-transparent flexible plastic packaging with black and transparent print writing, 100% USA Made and Sourced, UPC 091037018144. ","Best By dates of 04202014 DEN to 10032014 DEN.",,"5,112 - 5oz bags","Kasel Industries received a 423(a), Notification of Opportunity to Initiate a Voluntary Recall, letter from FDA and is recalling all lots of pet treats manufactured at their facility between April 20, 2012 and September 19, 2012 due to positive Salmonella findings in the firm's products and facility. ",2/19/2013,"02/19/2013",7/31/2013,"07/31/2013"
"Veterinary",64392,"Ongoing","Kasel Associates Industries, Inc.","Denver","CO","US","Voluntary: Firm Initiated","Telephone","Nationwide distribution.","V-271-2013","Class I","TDBBS, Inc/Best Bully Sticks Knee Caps, 25 ct, Bulk.","Best By dates of 04202014 DEN to 10032014 DEN.",,"10 bags","Kasel Industries received a 423(a), Notification of Opportunity to Initiate a Voluntary Recall, letter from FDA and is recalling all lots of pet treats manufactured at their facility between April 20, 2012 and September 19, 2012 due to positive Salmonella findings in the firm's products and facility. ",2/19/2013,"02/19/2013",7/31/2013,"07/31/2013"
"Veterinary",64392,"Ongoing","Kasel Associates Industries, Inc.","Denver","CO","US","Voluntary: Firm Initiated","Telephone","Nationwide distribution.","V-258-2013","Class I","BIXBI Hip and Joint Lamb Jerky, 5 oz. Packaged in yellow and purple semi-transparent flexible plastic packaging with black and transparent print writing, 100% USA Made and Sourced, UPC 091037018120. ","Best By dates of 04202014 DEN to 10032014 DEN.",,"3,746 - 5oz bags","Kasel Industries received a 423(a), Notification of Opportunity to Initiate a Voluntary Recall, letter from FDA and is recalling all lots of pet treats manufactured at their facility between April 20, 2012 and September 19, 2012 due to positive Salmonella findings in the firm's products and facility. ",2/19/2013,"02/19/2013",7/31/2013,"07/31/2013"
"Veterinary",64392,"Ongoing","Kasel Associates Industries, Inc.","Denver","CO","US","Voluntary: Firm Initiated","Telephone","Nationwide distribution.","V-272-2013","Class I","TDBBS, Inc/Best Bully Sticks Pork Jerky Strips, 16 oz.","Best By dates of 04202014 DEN to 10032014 DEN.",,"100 bags","Kasel Industries received a 423(a), Notification of Opportunity to Initiate a Voluntary Recall, letter from FDA and is recalling all lots of pet treats manufactured at their facility between April 20, 2012 and September 19, 2012 due to positive Salmonella findings in the firm's products and facility. ",2/19/2013,"02/19/2013",7/31/2013,"07/31/2013"
"Veterinary",64392,"Ongoing","Kasel Associates Industries, Inc.","Denver","CO","US","Voluntary: Firm Initiated","Telephone","Nationwide distribution.","V-247-2013","Class I","Boots & Barkley American Pig Ear Strips 8 oz. Satisfies your dog's instinctive urge to chew. Ingredients: Pig Ears. Distributed by TARGET Corporation, Minneapolis, MN 55403, 2012 Target Brands, Inc. Made in U.S.A. Packaging is transparent with white, blue and red with red, black and blue print writing on the affixed label, UPC 085239403440.","Best By dates of 20APR2014 DEN to 03OCT2014 DEN.",,"36576 bags","Kasel Industries received a 423(a), Notification of Opportunity to Initiate a Voluntary Recall, letter from FDA and is recalling all lots of pet treats manufactured at their facility between April 20, 2012 and September 19, 2012 due to positive Salmonella findings in the firm's products and facility. ",2/19/2013,"02/19/2013",7/31/2013,"07/31/2013"
"Veterinary",64392,"Ongoing","Kasel Associates Industries, Inc.","Denver","CO","US","Voluntary: Firm Initiated","Telephone","Nationwide distribution.","V-287-2013","Class I","K9 Chicken Healthy Weight Jerky 5oz, UPC 669125507162.","Best By dates of 04202014 DEN to 10032014 DEN.",,"2000 - 5 oz bags","Kasel Industries received a 423(a), Notification of Opportunity to Initiate a Voluntary Recall, letter from FDA and is recalling all lots of pet treats manufactured at their facility between April 20, 2012 and September 19, 2012 due to positive Salmonella findings in the firm's products and facility. ",2/19/2013,"02/19/2013",7/31/2013,"07/31/2013"
"Veterinary",64392,"Ongoing","Kasel Associates Industries, Inc.","Denver","CO","US","Voluntary: Firm Initiated","Telephone","Nationwide distribution.","V-260-2013","Class I","BIXBI Hip and Joint Beef Liver Jerky, 5 oz. Packaged in yellow and red semi-transparent flexible plastic packaging with black and transparent print writing, 100% USA Made and Sourced, UPC 091037018106. ","Best By dates of 04202014 DEN to 10032014 DEN.",,"5,928 - 5oz bags","Kasel Industries received a 423(a), Notification of Opportunity to Initiate a Voluntary Recall, letter from FDA and is recalling all lots of pet treats manufactured at their facility between April 20, 2012 and September 19, 2012 due to positive Salmonella findings in the firm's products and facility. ",2/19/2013,"02/19/2013",7/31/2013,"07/31/2013"
"Veterinary",64392,"Ongoing","Kasel Associates Industries, Inc.","Denver","CO","US","Voluntary: Firm Initiated","Telephone","Nationwide distribution.","V-276-2013","Class I","TDBBS, Inc/Best Bully Sticks Beef Lobster Tails, 1ct, Bulk.","Best By dates of 04202014 DEN to 10032014 DEN.",,"10,000 bags","Kasel Industries received a 423(a), Notification of Opportunity to Initiate a Voluntary Recall, letter from FDA and is recalling all lots of pet treats manufactured at their facility between April 20, 2012 and September 19, 2012 due to positive Salmonella findings in the firm's products and facility. ",2/19/2013,"02/19/2013",7/31/2013,"07/31/2013"
"Veterinary",64392,"Ongoing","Kasel Associates Industries, Inc.","Denver","CO","US","Voluntary: Firm Initiated","Telephone","Nationwide distribution.","V-268-2013","Class I","Colorado Naturals Pork Jerky, 16 oz UPC 647263700157, Distributed by Petco/Kasel Industries/Menards.","Best By dates of 04202014 DEN to 10032014 DEN.",,"26,964 - 16oz bags","Kasel Industries received a 423(a), Notification of Opportunity to Initiate a Voluntary Recall, letter from FDA and is recalling all lots of pet treats manufactured at their facility between April 20, 2012 and September 19, 2012 due to positive Salmonella findings in the firm's products and facility. ",2/19/2013,"02/19/2013",7/31/2013,"07/31/2013"
"Veterinary",64392,"Ongoing","Kasel Associates Industries, Inc.","Denver","CO","US","Voluntary: Firm Initiated","Telephone","Nationwide distribution.","V-275-2013","Class I","TDBBS, Inc/Best Bully Sticks Pig Snouts, 25 ct, Bulk.","Best By dates of 04202014 DEN to 10032014 DEN.",,"400 bags","Kasel Industries received a 423(a), Notification of Opportunity to Initiate a Voluntary Recall, letter from FDA and is recalling all lots of pet treats manufactured at their facility between April 20, 2012 and September 19, 2012 due to positive Salmonella findings in the firm's products and facility. ",2/19/2013,"02/19/2013",7/31/2013,"07/31/2013"
"Veterinary",64392,"Ongoing","Kasel Associates Industries, Inc.","Denver","CO","US","Voluntary: Firm Initiated","Telephone","Nationwide distribution.","V-244-2013","Class I","Boots & Barkley American Beef Bully Stick, 12 inch. Satisfies your dog's instinctive urge to chew. Ingredients: Beef Pizzles. Distributed by TARGET Corporation, Minneapolis, MN 55403, 2012 Target Brands, Inc. Made in U.S.A. Packaging is transparent with white, blue and red with red, black and blue print writing on the affixed label, UPC 085239043165.","Best By dates of 20APR2014 DEN to 03OCT2014 DEN.",,"43,344 bags","Kasel Industries received a 423(a), Notification of Opportunity to Initiate a Voluntary Recall, letter from FDA and is recalling all lots of pet treats manufactured at their facility between April 20, 2012 and September 19, 2012 due to positive Salmonella findings in the firm's products and facility. ",2/19/2013,"02/19/2013",7/31/2013,"07/31/2013"
"Veterinary",64392,"Ongoing","Kasel Associates Industries, Inc.","Denver","CO","US","Voluntary: Firm Initiated","Telephone","Nationwide distribution.","V-285-2013","Class I","K9 Chicken Senior Jerky 5oz, UPC 669125507124.","Best By dates of 04202014 DEN to 10032014 DEN.",,"2000 - 5 oz bags","Kasel Industries received a 423(a), Notification of Opportunity to Initiate a Voluntary Recall, letter from FDA and is recalling all lots of pet treats manufactured at their facility between April 20, 2012 and September 19, 2012 due to positive Salmonella findings in the firm's products and facility. ",2/19/2013,"02/19/2013",7/31/2013,"07/31/2013"
"Veterinary",64392,"Ongoing","Kasel Associates Industries, Inc.","Denver","CO","US","Voluntary: Firm Initiated","Telephone","Nationwide distribution.","V-249-2013","Class I","Boots & Barkley American Braided Beef Bully Stick, 5 inch. Satisfies your dog's instinctive urge to chew. Ingredients: Beef Pizzles. Distributed by TARGET Corporation, Minneapolis, MN 55403, 2012 Target Brands, Inc. Made in U.S.A. Packaging is transparent with white, blue and red with red, black and blue print writing on the affixed label, UPC 085239043110.","Best By dates of 20APR2014 DEN to 03OCT2014 DEN.",,"43632 bags","Kasel Industries received a 423(a), Notification of Opportunity to Initiate a Voluntary Recall, letter from FDA and is recalling all lots of pet treats manufactured at their facility between April 20, 2012 and September 19, 2012 due to positive Salmonella findings in the firm's products and facility. ",2/19/2013,"02/19/2013",7/31/2013,"07/31/2013"
"Veterinary",64392,"Ongoing","Kasel Associates Industries, Inc.","Denver","CO","US","Voluntary: Firm Initiated","Telephone","Nationwide distribution.","V-259-2013","Class I","BIXBI Hip and Joint Chicken Breast Jerky, 5 oz. Packaged in yellow and green semi-transparent flexible plastic packaging with black and transparent print writing, 100% USA Made and Sourced, UPC 091037018083. ","Best By dates of 04202014 DEN to 10032014 DEN.",,"6,916 - 5oz bags","Kasel Industries received a 423(a), Notification of Opportunity to Initiate a Voluntary Recall, letter from FDA and is recalling all lots of pet treats manufactured at their facility between April 20, 2012 and September 19, 2012 due to positive Salmonella findings in the firm's products and facility. ",2/19/2013,"02/19/2013",7/31/2013,"07/31/2013"
"Veterinary",64392,"Ongoing","Kasel Associates Industries, Inc.","Denver","CO","US","Voluntary: Firm Initiated","Telephone","Nationwide distribution.","V-256-2013","Class I","BIXBI Skin and Coat Chicken Breast Jerky Treats, 5 oz. Packaged in orange and green semi-transparent flexible plastic packaging with black and transparent print writing, 100% USA Made and Sourced, UPC 091037018007. ","Best By dates of 04202014 DEN to 10032014 DEN.",,"3,339 - 5oz bags","Kasel Industries received a 423(a), Notification of Opportunity to Initiate a Voluntary Recall, letter from FDA and is recalling all lots of pet treats manufactured at their facility between April 20, 2012 and September 19, 2012 due to positive Salmonella findings in the firm's products and facility. ",2/19/2013,"02/19/2013",7/31/2013,"07/31/2013"
"Veterinary",64392,"Ongoing","Kasel Associates Industries, Inc.","Denver","CO","US","Voluntary: Firm Initiated","Telephone","Nationwide distribution.","V-270-2013","Class I","TDBBS, Inc/Best Bully Sticks Buffalo Hearts Sliced, 3 lbs, Bulk.","Best By dates of 04202014 DEN to 10032014 DEN.",,"10 bags","Kasel Industries received a 423(a), Notification of Opportunity to Initiate a Voluntary Recall, letter from FDA and is recalling all lots of pet treats manufactured at their facility between April 20, 2012 and September 19, 2012 due to positive Salmonella findings in the firm's products and facility. ",2/19/2013,"02/19/2013",7/31/2013,"07/31/2013"
"Veterinary",64392,"Ongoing","Kasel Associates Industries, Inc.","Denver","CO","US","Voluntary: Firm Initiated","Telephone","Nationwide distribution.","V-254-2013","Class I","BIXBI Skin and Coat Lamb Jerky, 5 oz. Packaged in purple and orange semi-transparent flexible plastic packaging with black and transparent print writing, 100% USA Made and Sourced, UPC 091037018045. ","Best By dates of 04202014 DEN to 10032014 DEN.",,"1,334 - 5 oz bags","Kasel Industries received a 423(a), Notification of Opportunity to Initiate a Voluntary Recall, letter from FDA and is recalling all lots of pet treats manufactured at their facility between April 20, 2012 and September 19, 2012 due to positive Salmonella findings in the firm's products and facility. ",2/19/2013,"02/19/2013",7/31/2013,"07/31/2013"
"Veterinary",64392,"Ongoing","Kasel Associates Industries, Inc.","Denver","CO","US","Voluntary: Firm Initiated","Telephone","Nationwide distribution.","V-241-2013","Class I","Nature's Deli Chicken Jerky Dog Treats, 2.5 lbs. bag, UPC 647263800208, 3 lbs UPC 647263800215, Division of Kasel Industries, Denver, CO 80205. Packaged in a transparent, flexible, plastic bag; the bag is yellow with black and white print writing and a photograph of a golden retriever dog on it.","Best By dates of 04202013 DEN to 10032013 DEN excluding Best By 09192013 DEN, which was recalled on 10/03/2012.",,"62,336 - 2.5 lbs bags; 88,704 - 3 lbs bags","Kasel Industries received a 423(a), Notification of Opportunity to Initiate a Voluntary Recall, letter from FDA and is recalling all lots of pet treats manufactured at their facility between April 20, 2012 and September 19, 2012 due to positive Salmonella findings in the firm's products and facility. ",2/19/2013,"02/19/2013",7/31/2013,"07/31/2013"
"Veterinary",64392,"Ongoing","Kasel Associates Industries, Inc.","Denver","CO","US","Voluntary: Firm Initiated","Telephone","Nationwide distribution.","V-262-2013","Class I","Petco Natural Pig Ears, 25 pk, UPC 800443092903, 12 pk UPC 800443092910, 7 pk UPC 800443092934.","Best By dates of 04202014 DEN to 10032014 DEN.",,"6,944 - 12ct bags; 6,048 - 7ct bags; 7,992 - 25 ct bags","Kasel Industries received a 423(a), Notification of Opportunity to Initiate a Voluntary Recall, letter from FDA and is recalling all lots of pet treats manufactured at their facility between April 20, 2012 and September 19, 2012 due to positive Salmonella findings in the firm's products and facility. ",2/19/2013,"02/19/2013",7/31/2013,"07/31/2013"
"Veterinary",64392,"Ongoing","Kasel Associates Industries, Inc.","Denver","CO","US","Voluntary: Firm Initiated","Telephone","Nationwide distribution.","V-251-2013","Class I","Boots & Barkley American Beef Knuckle, 14 oz. Promotes Plaque and Tartar Reduction. Ingredients: Beef Knuckle. Distributed by TARGET Corporation, Minneapolis, MN 55403, 2012 Target Brands, Inc. Packaging is semi-transparent with white, blue and red with red, black and blue print writing on the affixed label. The labeling also has digital photo of a dog. UPC 647263899172.","Best By dates of 20APR2014 DEN to 03OCT2014 DEN.",,"48060 bags","Kasel Industries received a 423(a), Notification of Opportunity to Initiate a Voluntary Recall, letter from FDA and is recalling all lots of pet treats manufactured at their facility between April 20, 2012 and September 19, 2012 due to positive Salmonella findings in the firm's products and facility. ",2/19/2013,"02/19/2013",7/31/2013,"07/31/2013"
"Veterinary",64392,"Ongoing","Kasel Associates Industries, Inc.","Denver","CO","US","Voluntary: Firm Initiated","Telephone","Nationwide distribution.","V-257-2013","Class I","BIXBI Skin and Coat Pork Jerky, 5 oz. Packaged in orange and aqua semi-transparent flexible plastic packaging with black and transparent print writing, 100% USA Made and Sourced, UPC 091037018069. ","Best By dates of 04202014 DEN to 10032014 DEN.",,"4,938 - 5oz bags","Kasel Industries received a 423(a), Notification of Opportunity to Initiate a Voluntary Recall, letter from FDA and is recalling all lots of pet treats manufactured at their facility between April 20, 2012 and September 19, 2012 due to positive Salmonella findings in the firm's products and facility. ",2/19/2013,"02/19/2013",7/31/2013,"07/31/2013"
"Veterinary",64392,"Ongoing","Kasel Associates Industries, Inc.","Denver","CO","US","Voluntary: Firm Initiated","Telephone","Nationwide distribution.","V-243-2013","Class I","Boots & Barkley Loving your pet from head to tail. American Variety Pack Real Beef & Pork. Treats for Dogs. Product of U.S.A. Distributed by TARGET Corporation, Minneapolis, MN 55403, net wt 32 oz. Packaging is white, blue and red with red, black and blue print writing, UPC 490830400086.","Best by dates of 20APR2014 DEN to 03OCT2014 DEN, excluding Best By 13SEP2014DEN, which was recalled on 10/17/2012.",,"6,720 - 32oz bags","Kasel Industries received a 423(a), Notification of Opportunity to Initiate a Voluntary Recall, letter from FDA and is recalling all lots of pet treats manufactured at their facility between April 20, 2012 and September 19, 2012 due to positive Salmonella findings in the firm's products and facility. ",2/19/2013,"02/19/2013",7/31/2013,"07/31/2013"
"Veterinary",64392,"Ongoing","Kasel Associates Industries, Inc.","Denver","CO","US","Voluntary: Firm Initiated","Telephone","Nationwide distribution.","V-278-2013","Class I","TDBBS, Inc/Best Bully Sticks hearts of Lamb, 4 oz.","Best By dates of 04202014 DEN to 10032014 DEN.",,"200 bags","Kasel Industries received a 423(a), Notification of Opportunity to Initiate a Voluntary Recall, letter from FDA and is recalling all lots of pet treats manufactured at their facility between April 20, 2012 and September 19, 2012 due to positive Salmonella findings in the firm's products and facility. ",2/19/2013,"02/19/2013",7/31/2013,"07/31/2013"
"Veterinary",64392,"Ongoing","Kasel Associates Industries, Inc.","Denver","CO","US","Voluntary: Firm Initiated","Telephone","Nationwide distribution.","V-242-2013","Class I","Boots & Barkley Loving your pet from head to tail. Roasted American Pig Ears. Delicious Treat for Dogs, Made in the U.S.A. Distributed by TARGET Corporation, Minneapolis, MN 55403, net wt 12 oz, 12 count, UPC 647263899158.","Best By dates of 20APR2014 DEN to 03OCT2014 DEN, excluding Best By 13SEP2014DEN, which was recalled on 10/17/2012.",,"67,200 - 12ct bags","Kasel Industries received a 423(a), Notification of Opportunity to Initiate a Voluntary Recall, letter from FDA and is recalling all lots of pet treats manufactured at their facility between April 20, 2012 and September 19, 2012 due to positive Salmonella findings in the firm's products and facility. ",2/19/2013,"02/19/2013",7/31/2013,"07/31/2013"
"Veterinary",64392,"Ongoing","Kasel Associates Industries, Inc.","Denver","CO","US","Voluntary: Firm Initiated","Telephone","Nationwide distribution.","V-266-2013","Class I","Colorado Naturals Chicken Jerky, 4 oz UPC 647263800178, 16 oz UPC 647263800291. Distributed by Petco/Kasel/Menards Industries.","Best By dates of 04202014 DEN to 10032014 DEN.",,"20,736 - 4oz bags, 31,878 x 16 oz","Kasel Industries received a 423(a), Notification of Opportunity to Initiate a Voluntary Recall, letter from FDA and is recalling all lots of pet treats manufactured at their facility between April 20, 2012 and September 19, 2012 due to positive Salmonella findings in the firm's products and facility. ",2/19/2013,"02/19/2013",7/31/2013,"07/31/2013"
"Veterinary",64392,"Ongoing","Kasel Associates Industries, Inc.","Denver","CO","US","Voluntary: Firm Initiated","Telephone","Nationwide distribution.","V-250-2013","Class I","Boots & Barkley American Chicken Jerky, 16 oz UPC 085239043325; 8 oz UPC 085239043400. Satisfies your dog's instinctive urge to chew. Ingredients: Chicken Breast, Natural Flavorings. Distributed by TARGET Corporation, Minneapolis, MN 55403, 2012 Target Brands, Inc. Made in U.S.A. Packaging is semi-transparent with white, blue and red with red, black and blue print writing on the affixed label. The labeling also has digital photos of the chicken strips and a picture of a terrier dog.","Best By dates of 20APR2014 DEN to 03OCT2014 DEN.",,"22116 - 16oz bags; 24768 - 8oz bags","Kasel Industries received a 423(a), Notification of Opportunity to Initiate a Voluntary Recall, letter from FDA and is recalling all lots of pet treats manufactured at their facility between April 20, 2012 and September 19, 2012 due to positive Salmonella findings in the firm's products and facility. ",2/19/2013,"02/19/2013",7/31/2013,"07/31/2013"
"Veterinary",64392,"Ongoing","Kasel Associates Industries, Inc.","Denver","CO","US","Voluntary: Firm Initiated","Telephone","Nationwide distribution.","V-274-2013","Class I","TDBBS, Inc/Best Bully Sticks Turkey Cubes, 4.5 oz.","Best By dates of 04202014 DEN to 10032014 DEN.",,"36 bags","Kasel Industries received a 423(a), Notification of Opportunity to Initiate a Voluntary Recall, letter from FDA and is recalling all lots of pet treats manufactured at their facility between April 20, 2012 and September 19, 2012 due to positive Salmonella findings in the firm's products and facility. ",2/19/2013,"02/19/2013",7/31/2013,"07/31/2013"
"Veterinary",64392,"Ongoing","Kasel Associates Industries, Inc.","Denver","CO","US","Voluntary: Firm Initiated","Telephone","Nationwide distribution.","V-267-2013","Class I","Colorado Naturals Lamb Jerky, 4 oz UPC 647263510176, Distributed by Petco/Kasel Industries.","Best By dates of 04202014 DEN to 10032014 DEN.",,"18,432 - 4oz bags","Kasel Industries received a 423(a), Notification of Opportunity to Initiate a Voluntary Recall, letter from FDA and is recalling all lots of pet treats manufactured at their facility between April 20, 2012 and September 19, 2012 due to positive Salmonella findings in the firm's products and facility. ",2/19/2013,"02/19/2013",7/31/2013,"07/31/2013"
"Veterinary",64392,"Ongoing","Kasel Associates Industries, Inc.","Denver","CO","US","Voluntary: Firm Initiated","Telephone","Nationwide distribution.","V-246-2013","Class I","Boots & Barkley American Beef Tendon Flossie 6-8 inch. Satisfies your dog's instinctive urge to chew. Ingredients: Beef Tendon. Distributed by TARGET Corporation, Minneapolis, MN 55403, 2012 Target Brands, Inc. Made in U.S.A. Packaging is transparent with white, blue and red with red, black and blue print writing on the affixed label, UPC 085239043103.","Best By dates of 20APR2014 DEN to 03OCT2014 DEN.",,"36288 bags","Kasel Industries received a 423(a), Notification of Opportunity to Initiate a Voluntary Recall, letter from FDA and is recalling all lots of pet treats manufactured at their facility between April 20, 2012 and September 19, 2012 due to positive Salmonella findings in the firm's products and facility. ",2/19/2013,"02/19/2013",7/31/2013,"07/31/2013"
"Veterinary",64392,"Ongoing","Kasel Associates Industries, Inc.","Denver","CO","US","Voluntary: Firm Initiated","Telephone","Nationwide distribution.","V-277-2013","Class I","TDBBS, Inc/Best Bully Sticks Turkey Jerky Sticks, 6 ct.","Best By dates of 04202014 DEN to 10032014 DEN.",,"200 bags","Kasel Industries received a 423(a), Notification of Opportunity to Initiate a Voluntary Recall, letter from FDA and is recalling all lots of pet treats manufactured at their facility between April 20, 2012 and September 19, 2012 due to positive Salmonella findings in the firm's products and facility. ",2/19/2013,"02/19/2013",7/31/2013,"07/31/2013"
"Veterinary",64392,"Ongoing","Kasel Associates Industries, Inc.","Denver","CO","US","Voluntary: Firm Initiated","Telephone","Nationwide distribution.","V-269-2013","Class I","Colorado Naturals Beef Jerky, 4 oz UPC 647263801175, Distributed by Petco/Kasel Industries.","Best By dates of 04202014 DEN to 10032014 DEN.",,"13,824 - 4oz bags","Kasel Industries received a 423(a), Notification of Opportunity to Initiate a Voluntary Recall, letter from FDA and is recalling all lots of pet treats manufactured at their facility between April 20, 2012 and September 19, 2012 due to positive Salmonella findings in the firm's products and facility. ",2/19/2013,"02/19/2013",7/31/2013,"07/31/2013"
"Veterinary",64392,"Ongoing","Kasel Associates Industries, Inc.","Denver","CO","US","Voluntary: Firm Initiated","Telephone","Nationwide distribution.","V-288-2013","Class I","K9 Chicken Jerky 5oz, UPC 669125507018 ; 8oz , UPC 669125507025; 16oz , UPC 669125507032","Best By dates of 04202014 DEN to 10032014 DEN.",,"2000 - 5 oz bags; 2000 - 8 oz bags; 2000 - 16 oz bags","Kasel Industries received a 423(a), Notification of Opportunity to Initiate a Voluntary Recall, letter from FDA and is recalling all lots of pet treats manufactured at their facility between April 20, 2012 and September 19, 2012 due to positive Salmonella findings in the firm's products and facility. ",2/19/2013,"02/19/2013",7/31/2013,"07/31/2013"
"Veterinary",64392,"Ongoing","Kasel Associates Industries, Inc.","Denver","CO","US","Voluntary: Firm Initiated","Telephone","Nationwide distribution.","V-281-2013","Class I","K9 Chicken Joint Jerky 5oz UPC 669125507049; 15oz, UPC 669125507056","Best By dates of 04202014 DEN to 10032014 DEN.",,"2000 - 5oz bags; 3600 - 15 oz bags","Kasel Industries received a 423(a), Notification of Opportunity to Initiate a Voluntary Recall, letter from FDA and is recalling all lots of pet treats manufactured at their facility between April 20, 2012 and September 19, 2012 due to positive Salmonella findings in the firm's products and facility. ",2/19/2013,"02/19/2013",7/31/2013,"07/31/2013"
"Veterinary",64392,"Ongoing","Kasel Associates Industries, Inc.","Denver","CO","US","Voluntary: Firm Initiated","Telephone","Nationwide distribution.","V-265-2013","Class I","Colorado Naturals Salmon Jerky, 4 oz UPC 647263900175. Distributed by Petco/Kasel Industries.","Best By dates of 04202014 DEN to 10032014 DEN.",,"16,128 - 4oz bags","Kasel Industries received a 423(a), Notification of Opportunity to Initiate a Voluntary Recall, letter from FDA and is recalling all lots of pet treats manufactured at their facility between April 20, 2012 and September 19, 2012 due to positive Salmonella findings in the firm's products and facility. ",2/19/2013,"02/19/2013",7/31/2013,"07/31/2013"
"Veterinary",64392,"Ongoing","Kasel Associates Industries, Inc.","Denver","CO","US","Voluntary: Firm Initiated","Telephone","Nationwide distribution.","V-253-2013","Class I","BIXBI Skin and Coat Beef Liver Jerky, 5 oz. Packaged in orange semi-transparent flexible plastic packaging, 100% USA Made and Sourced, UPC 091037018021. ","Best By dates of 04202014 DEN to 10032014 DEN.",,"4,750 - 5oz bags","Kasel Industries received a 423(a), Notification of Opportunity to Initiate a Voluntary Recall, letter from FDA and is recalling all lots of pet treats manufactured at their facility between April 20, 2012 and September 19, 2012 due to positive Salmonella findings in the firm's products and facility. ",2/19/2013,"02/19/2013",7/31/2013,"07/31/2013"
"Devices",64393,"Ongoing","Philips Medical Systems (Cleveland) Inc","Cleveland","OH","US",,"Letter","Distributed to one customer in Ohio.","Z-1029-2013","Class II","Ingenuity TF PET/CT. Diagnostic imaging system that combines Positron Emission Tomography (PET) and X-ray Computed Tomography (CT) systems. ","Model #: 882456; Serial #: 2004",".","1","Issues have been detected in the Ingenuity TF PET/CT currently running software version 4.0.60605.0 that if they were to re-occur, could cause a risk for patients, users or service personnel, including inaccurate standard uptake values (SUV). Philips Medical Systems (Cleveland), Inc. is issuing a software update to address the issues.",12/20/2012,"12/20/2012",4/10/2013,"04/10/2013"
"Devices",64394,"Ongoing","Biomerieux Inc","Hazelwood","MO","US","Voluntary: Firm Initiated","E-Mail","Worldwide Distribution-USA (nationwide) and the countries of Algeria, Angola, Argentina, Australia, Austria, Azerbaidjian, Bahrain, Belarus, Belgium, Benin, Bolivia, Bosnia, Brazil, Bulgaria, Burkina Faso, Camaroun, Canada, Chad, Chile, China, Colombia, Costa Rica, Croatia, Czech Republic, Democratic Republic of Congo, Demark, Dominican Republic, Dutch Antilles, Ecuador, Egypt, El Salvador, Ethiopia, Finland, France, Gabon, Georgia, Germany, Greece, Guatemala, Guinea, Herzegovina, Honduras, Hungary, India, Indonesia, Iraq, Ireland, Israel, Italy, Japan, Jordan, Kazakhstan, Kenya, Korea, Kosovo, Kuwait, Latvia, Lebanon, Libya, Lithuania, Macedonia, Malaysia, Mali, Mexico, Moldavia, Mongolia, Morocco, Myanmar, Netherlands, Netherlands, Nicaragua, Niger Niamey, Nigeria, Norway, Oman, Panama, Paraguay, Peru, Philippines, Poland, Portugal, Puerto Rico, Qatar, Romania, Russia, Saudi Arabia, Serbia, Singapore, Slovenia, South Africa, Spain, Sweden, Switzerland, Thailand, Tunisia, Turkey, Uganda, Ukraine, United Arab Emirates, United Kingdom, Uruguay, Venezuela, Vietnam, and Yemen.","Z-0989-2013","Class II","VITEK 2 60 computer system when equipped with the following Hewlett-Packard PC models: (1) rp5700, Cat. #W0452; (2) rp5700 (refurbished), Cat. #W0452R; (3) rp5800 XPE, Cat. 413642; (4) rp5800 WES7, Cat. #413862; (5) dc7100 8-port, Cat. #W0441; (6) dc7100 8-port (refurbished), Cat. #W0441R; (7) dc7700 8-port, Cat. #W0447; (8) dc7700 8-port (refurbished), Cat. #W0447R; (9) dc7800, Cat. #W0449; and (10) dc7800 (refurbished), Cat. #W0449R. VITEK 2 is an automated system designed for the identification and antimicrobial susceptibility testing of bacteria and yeast. ","Manufactured from September, 2004, to present.",,"For all 3 computers types: 16,736 originally distributed; 554 refurbished and redistributed","There is a potential to link an isolate result to the wrong patient and then upload the results to the LIS.",2/18/2013,"02/18/2013",4/3/2013,"04/03/2013"
"Devices",64394,"Ongoing","Biomerieux Inc","Hazelwood","MO","US","Voluntary: Firm Initiated","E-Mail","Worldwide Distribution-USA (nationwide) and the countries of Algeria, Angola, Argentina, Australia, Austria, Azerbaidjian, Bahrain, Belarus, Belgium, Benin, Bolivia, Bosnia, Brazil, Bulgaria, Burkina Faso, Camaroun, Canada, Chad, Chile, China, Colombia, Costa Rica, Croatia, Czech Republic, Democratic Republic of Congo, Demark, Dominican Republic, Dutch Antilles, Ecuador, Egypt, El Salvador, Ethiopia, Finland, France, Gabon, Georgia, Germany, Greece, Guatemala, Guinea, Herzegovina, Honduras, Hungary, India, Indonesia, Iraq, Ireland, Israel, Italy, Japan, Jordan, Kazakhstan, Kenya, Korea, Kosovo, Kuwait, Latvia, Lebanon, Libya, Lithuania, Macedonia, Malaysia, Mali, Mexico, Moldavia, Mongolia, Morocco, Myanmar, Netherlands, Netherlands, Nicaragua, Niger Niamey, Nigeria, Norway, Oman, Panama, Paraguay, Peru, Philippines, Poland, Portugal, Puerto Rico, Qatar, Romania, Russia, Saudi Arabia, Serbia, Singapore, Slovenia, South Africa, Spain, Sweden, Switzerland, Thailand, Tunisia, Turkey, Uganda, Ukraine, United Arab Emirates, United Kingdom, Uruguay, Venezuela, Vietnam, and Yemen.","Z-0990-2013","Class II","VITEK 2 XL computer system when equipped with the following Hewlett-Packard PC models: (1) rp5700, Cat. #W0452; (2) rp5700 (refurbished), Cat. #W0452R; (3) rp5800 XPE, Cat. 413642; (4) rp5800 WES7, Cat. #413862; (5) dc7100 8-port, Cat. #W0441; (6) dc7100 8-port (refurbished), Cat. #W0441R; (7) dc7700 8-port, Cat. #W0447; (8) dc7700 8-port (refurbished), Cat. #W0447R; (9) dc7800, Cat. #W0449; and (10) dc7800 (refurbished), Cat. #W0449R. VITEK 2 is an automated system designed for the identification and antimicrobial susceptibility testing of bacteria and yeast. ","Manufactured from September, 2004, to present.",,"For all 3 computers types: 16,736 originally distributed; 554 refurbished and redistributed","There is a potential to link an isolate result to the wrong patient and then upload the results to the LIS.",2/18/2013,"02/18/2013",4/3/2013,"04/03/2013"
"Devices",64394,"Ongoing","Biomerieux Inc","Hazelwood","MO","US","Voluntary: Firm Initiated","E-Mail","Worldwide Distribution-USA (nationwide) and the countries of Algeria, Angola, Argentina, Australia, Austria, Azerbaidjian, Bahrain, Belarus, Belgium, Benin, Bolivia, Bosnia, Brazil, Bulgaria, Burkina Faso, Camaroun, Canada, Chad, Chile, China, Colombia, Costa Rica, Croatia, Czech Republic, Democratic Republic of Congo, Demark, Dominican Republic, Dutch Antilles, Ecuador, Egypt, El Salvador, Ethiopia, Finland, France, Gabon, Georgia, Germany, Greece, Guatemala, Guinea, Herzegovina, Honduras, Hungary, India, Indonesia, Iraq, Ireland, Israel, Italy, Japan, Jordan, Kazakhstan, Kenya, Korea, Kosovo, Kuwait, Latvia, Lebanon, Libya, Lithuania, Macedonia, Malaysia, Mali, Mexico, Moldavia, Mongolia, Morocco, Myanmar, Netherlands, Netherlands, Nicaragua, Niger Niamey, Nigeria, Norway, Oman, Panama, Paraguay, Peru, Philippines, Poland, Portugal, Puerto Rico, Qatar, Romania, Russia, Saudi Arabia, Serbia, Singapore, Slovenia, South Africa, Spain, Sweden, Switzerland, Thailand, Tunisia, Turkey, Uganda, Ukraine, United Arab Emirates, United Kingdom, Uruguay, Venezuela, Vietnam, and Yemen.","Z-0991-2013","Class II","VITEK 2 Compact computer system when equipped with the following Hewlett-Packard PC models: (1) dc7100 8-port, Cat. #W0441; (2) dc7100 8-port (refurbished), Cat. #W0441R; (3) dc7700 8-port, Cat. #W0447; (4) dc7700 8-port (refurbished), Cat. #W0447R; (5) dc7800, Cat. #W0449; (6) dc7800 (refurbished), Cat. #W0449R (7) rp5700, Cat. #W0452; (8) rp5700 (refurbished), Cat. #W0452R; (9) rp5800 XPE, Cat. 413642; (10) rp5800WES7, Cat. #413862; (11) d530 6-port, Cat. #W0438; (12) d530 6-port (refurbished), Cat. #W0438R; and (13) d530 4-port, Cat. #W0437. VITEK 2 is an automated system designed for the identification and antimicrobial susceptibility testing of bacteria and yeast. ","Manufactured from September, 2004, to present.",,"For all 3 computers types: 16,736 originally distributed; 554 refurbished and redistributed","There is a potential to link an isolate result to the wrong patient and then upload the results to the LIS.",2/18/2013,"02/18/2013",4/3/2013,"04/03/2013"
"Devices",64395,"Ongoing","Endogastric Solutions Inc","Redmond","WA","US","Voluntary: Firm Initiated","Letter","Nationwide Distribution including NC, VA, WI, TN, KY, IN, FL, MI, IA, IL, TX, LA, AR, HI, CA, NV, OR, and WA,","Z-1136-2013","Class II","EndoGastric Solutions EsophyX2 Plus Device with Serosa Fastener and Accessories Part number C02033-01. Label reads in part ''EsophyX2 2-LINK Device Qty: (1) Fastener Delivery System ***'' Designed for the treatment of Gastroesophageal Reflux Disease (GERD), with erosive and non-erosive esophagitis","Lots 401378, 401392, 401409, and 401416 Additional lots manufactured from 11/26/12 to 12/07/12 had a stop ship issued issued on 11/21/12 and the product was placed in quarantine (it was not distributed). This represents an additional 175 units from a total of 187 units manufactured during this time period. 12 units were used for bench testing. The lot numbers of units in quarantine are 401432, 401434, 401436, and 401441.",".","190","EsophyX2Plus device was not validated under actual or simulated use conditions prior to distributing the product to physicians.",2/4/2013,"02/04/2013",4/24/2013,"04/24/2013"
"Food",64396,"Ongoing","Rich Products Corp","Buffalo","NY","US","Voluntary: Firm Initiated","Letter","NY, PA, VA, TN, IN, MI, WI, MN, SD, ND, IL, MO, NE, KS, OK, TX, CA, WA","F-1052-2013","Class II","ALL NATURAL ANCIENT GRAIN BREAD, NET WT. 13.8 OZ. (393 g), PRODUCT OF CANADA, UPC 0 49800 08712 5 (appears on bag), Product Code 08712 --- RICH PRODUCTS CORP., BUFFALO, NY 14213 --- The product is a frozen bread dough packaged in a plastic bag with 24 plastic bags per case. The frozen dough is sold to in-store bakeries and food service customers.","Product produced from July 27, 2012 through February 1, 2013 (Julian Dates 77002209 - 77003302) ",,"Approximately 6,000 cases ","Product was manufactured with bulk flour supplied by Dakota Specialty Milling which is being recalled due to reports of metal fragments.. ",2/13/2013,"02/13/2013",3/13/2013,"03/13/2013"
"Food",64397,"Ongoing","Rich Products Corp","Buffalo","NY","US","Voluntary: Firm Initiated","Letter","CA, CO, TX, UT, SC, NC, WA, NM","F-1053-2013","Class II","Sara Lee Thin Style Buns, 100% Multi-Grain, 1.5 oz., Goglanian Bakeries Product Code 77474, UPC 072945611788 --- The product is packaged in a plastic bag with a green bag clip. There are 8 buns per retail package (plastic bag) and there are 18 bags per tray. ","Production Date Green Bag Clip Code 7/24/12 G01206Gxx* 8/1/12 G01214Gxx* 8/6/12 G01219Gxx* 8/30/12 G01243Gxx* 9/26/12 G01270Gxx* 10/17/12 G01291Gxx* 11/28/12 G01333Gxx* 12/16/12 G01351Gxx* 12/31/12 G01366Gxx* 1/18/13 G01018Gxx* (*xx denotes the hour of production and will be represented by two numeric digits (e.g. 09 would mean 9:00 a.m. production hour). ",,"Sara Lee Buns: 17,238 cases","The product was manufactured with bulk flour supplied by Dakota Specialty Milling. Dakota Specialty Milling is recalling the bulk flour because of reports of metal fragments (stainless steel) caused by a faulty mesh screen. ",2/13/2013,"02/13/2013",3/13/2013,"03/13/2013"
"Food",64397,"Ongoing","Rich Products Corp","Buffalo","NY","US","Voluntary: Firm Initiated","Letter","CA, CO, TX, UT, SC, NC, WA, NM","F-1054-2013","Class II","Daphne's California 6 inch Multigrain Flatbread, 2.1 oz., Product Code 77468, Net Wt. 13.50 lbs. (case) --- There are 12 - 10 count bags per case","Production Date Bag Clip Code Case Jet Code09/06/2012 09/06/12 09/06/12 L1 HH:MM 11/13/2012 11/13/12 11/13/12 L1 HH:MM 01/20/2013 01/20/13 01/20/13 L1 HH:MM *HH:MM denotes the hour and minute of production and will be represented by four numeric digits (e.g. 09:20 would mean 9:20 a.m. time of production) ",,"Daphne's Flatbread: 1,254 cases","The product was manufactured with bulk flour supplied by Dakota Specialty Milling. Dakota Specialty Milling is recalling the bulk flour because of reports of metal fragments (stainless steel) caused by a faulty mesh screen. ",2/13/2013,"02/13/2013",3/13/2013,"03/13/2013"
"Devices",64398,"Completed","GE Healthcare, LLC","Waukesha","WI","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution - USA (nationwide) including DC and PR and the countries of UKRAINE, TAIWAN, TURKEY, TUNISIA, THAILAND, SINGAPORE, SWEDEN, SAUDI ARABIA, RUSSIAN FEDERATION, PORTUGAL, POLAND, PAKISTAN, PHILIPPINES, PANAMA, NEW ZEALAND, NORWAY NETHERLANDS, MALAYSIA, MEXICO, MALTA, MARTINIQUE, MOROCCO, LATVIA, LITHUANIA, LEBANON, KUWAIT, KOREA, JAPAN, JORDAN, ITALY, IRAN, INDIA, ISRAEL, IRELAND, INDONESIA, HUNGARY, CORATIA, HONG KONG, GREECE, GEORGIA, UNITED KINGDOM, FRANCE, FINLAND, SPAIN, EGYPT, ECUADOR, ALGERIA, DOMINICAN REPUBLIC, DENMARK, GERMANY, CZECH REPUBLIC, CYPRUS, COLUMBIA, CHILE, SWITZERLAND, CANADA, CHINA, BRAZIL, BELGIUM, AUSTRALIA, AUSTRIA, ARGENTINA, SOUTH AFRICA, VENEZUELA, URUGUAY, ALGERIA.","Z-1078-2013","Class II","GE Healthcare Quasar Nuclear Medicine System, Hawkeye Option and Hawkeye 4 Option for Dual-Head Variable Angle Gamma Camera. Nuclear Medicine imaging systems. Recall includes all Infinia systems, all configurations.","787764INFINIA-1 SA2146NM01 TN1366NM01 SA1001MN01 PK1031NM01 PK1032NM01 PK1180NM08 PK1184NM01 PK1307NM01 PK1336NM01 MA1439NM01 LB1122NM02 KW1013NM01 KW1013NM02 KW1018MN06 KW1018MN08 EG1124MN02 323268INF1 630312INF 630545INF 630856INF 630275INF 330344INFINIA1 518262INF1 518262INF2 518262INF3 724226INF1 ARHINFI 610770INFINIA 502893INF 443481BINF 443481INF 443481INF2 661949NUC1 804594INF1 480323INFRM1 607737INF 404265INF 330363INFINIA 920451INF 920907INF 305682INF1 602588INF 904821INF3 904821NM1 904821NM2 615284INF1 904627INF2 904321INF1 904202INF1 501202INF 662244INFINIA 225381INF 972394INF 727863INF1 713359INF1 419483NUC2 406731INF1 228436INF 865977INF 804281INF1 804225INF1 941VRMCINF 248471INF 203384INF 269657SHINF 718240INF2 718240INF1 BCHINF1 513454INF1 843402INF2 843606INF1 609730INF1 GILESINF 217554CINF 843674IN1 843674IN2 843674IN3 704225INF1 704355INF1 704355INF2 704863INF1 770382INM 973877INFINIA 859313INF 423625INFINIA 859498INF1 937440INF2 606878INF1 606878INF2 512528NM1 305325INF 615342INF1 816380CASSINF 816392RINF 816836CIIN SLGHINF 207795INFINIA 518562INF 757312INF1 757312INF2 410337INF3 973831INFINIA 708684INF1 302733INF 318681INFINIA2 281599INF1 805489INF1 352344INF 256327NUC 704487INFINIA1 718948INF 843782INF 931403NM1 256429INF1 CFRHINF 727521INF 904276INF1 702255INF 210617NM1 847990INF1 814533INF2 814534INF 607756INF 607756INF2 740623INFINIA 319272INF CRAVENINF2 CRAVENINF3 CRAVENINF1 618544INF 402449INF 337436INF 318798INFINIA 203797INF 304637INF 205750INF 205759INF 256341NRM1 760778INF1 702369NM 760241INF1 850883ENM 904542NM 502624INF 727581INF 630786INF 786308INF1 786308INF2 214324INF 919684INF3 318330INF1 843412INF 504454INF 303837INF 330721INFINIA1 330721INFINIA2 502350INF 904819INF1 928214INF FHEINF 954735INF2 813788INF1 225647INF 318327INF1 318388INF1 601288INF1 865373INF 865429INFINIA 240566INF 256494NM1 316858GI 662256INFINIA 561650INF1 843692IN1 319768INF 319768INF2 770229INF 979532INF1 706278INF 828586INFINIA 262670INF2 978521INF 517543INF 727942INF 256386HKNM2 906293INF 618942INF 305",,"2180","Accelerated fatigue of the lateral axis motion subsystem of the Infinia Computed Emission Tomography System could result in mechanical failure causing the detector to slide; may impact patient and operators.",3/6/2012,"03/06/2012",4/17/2013,"04/17/2013"
"Biologics",64399,"Terminated","Plasma Biological Services","Asheville","NC","US","Voluntary: Firm Initiated","FAX","California","B-1182-13","Class III","Source Plasma","12ANCE5442; ",".","1","Blood product, collected from a donor whose arm inspection was not documented, was distributed. ",1/25/2013,"01/25/2013",6/19/2013,"06/19/2013"
"Biologics",64400,"Terminated","Mississippi Valley Reg Bld Ctr","Davenport","IA","US","Voluntary: Firm Initiated","Letter","Iowa","B-1181-13","Class II","Red Blood Cells Leukocytes Reduced","W333612086754; ",".","1","Blood product, collected from a donor who reported travel to a malarial endemic area, was distributed.",1/10/2013,"01/10/2013",6/19/2013,"06/19/2013"
"Devices",64401,"Ongoing","Philips Medical Systems (Cleveland) Inc","Cleveland","OH","US",,"Letter","Worldwide Distribution - Nationwide Distribution including the states of AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, PR, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV and WY.","Z-0945-2013","Class II","Brilliance 6, 10, 16, 40, 64, Big Bore and the iCT, iCT SP, Ingenuity CT and MX8000 Dual v. EXP are Computed Tomography X-Ray Systems. These devices are Computed Tomography X-Ray Systems that are intended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission data taken at different angles and planes. These devices may include signal analysis and display equipment, patient, and equipment supports, components and accessories. ","System Code #728256, Serial #: 3001,3016,3019,3020,3025,3026,3030,3057,3058,3060,3071,3073,3074,3076,3080,3090,3095,3108,3114,3119,3124,3138,3151,3155,3167,3168,3174,3178,3186,3187,3192,3193,3196,3208,3210,3212,3213,3214,3218,3226,3245,3257,3264,3267,3269,3273,3274,3275,3281,3284,3289,3291,3296,3304,3306,3309,3313,3317,3327,3331,3336,3337,3339,3340,3341,3342,3344,3345,3346,3347,3348,3349,3350,3351,3352,3354,3355,3356,3357,3358,3359,3360,3361,3362,3363,3364,3365,3366,3367,3368,3369,3370,3371,3372,3373,3374,3375,3376,3377,3378,3379,3380,3381,3382,3383,3384,3385,3386,3387,3388,3389,3390,3391,3392,3393,3394,3395,3396,3397,3398,3399,3400,3402,3403,3404,3405,3406,3408,3409,3410,3411,3412,3413,3414,3415,3416,3417,3418,3419,3420,3421,3422,3423,3424,3425,3426,3427,3428,3429,3430,3431,3432,3433,3434,3435,3436,3437,3438,3439,3440,3441,3443,3444,3445,3447,3449,3450,3451,3452,3453,3454,3455,3456,3457,3458,3459,3460,3461,3462,3463,3464,3465,3466,3467,3468,3469,3470,3471,3472,3473,3474,3475,3476,3477,3478,3479,3480,3481,3482,3483,3484,3485,3486,3487,3488,3489,3490,3491,3492,3493,3494,3495,3496,3497,3498,3499,3500,3501,3502,3503,3504,3505,3506,3507,3508,3509,3510,3511,3512,3513,3514,3515,3516,3517,3518,3519,3520,3521,3522,3523,3524,3525,3526,3527,3528,3529,3530,3531,3532,3533,3534,3535,3536,3537,3538,3539,3540,3541,3542,3543,3544,3545,3546,3547,3548,3549,3550,3551,3552,3553,3554,3555,3556,3557,3558,3559,3560,3561,3562,3563,3564,3565,3566,3567,3568,3569,3570,3571,3572,3573,3574,3575,3576,3577,3578,3579,3580,3581,3582,3583,3584,3585,3586,3587,3588,3589,3590,3591,3592,3593,3594,3595,3596,3597,3598,3599,3600,3601,3602,3603,3604,3605,3606,3607,3608,3609,3610,3611,3612,3613,3614,3615,3616,3617,3618,3619,3620,3621,3622,3623,3624,3625,3626,3627,3628,3629,3630,3631,3632,3633,3634,3635,3636,3637,3638,3639,3640,3641,3642,3643,3644,3645,3646,3647,3648,3649,3650,3651,3652,3653,3654,3655,3656,3657,3658,3659,3660,3661,3663,3664,3665,3666,3667,3668,3669,3670,3671,3672,3673,3674,3675,3676,3677,3678,3679,3680,3681,3682,3683,3684,3685,3686,3687",,"4797 Units","Philips Healthcare received reports from the field stating the patient table on a system had an unexpected downward movement while a patient was on the table. Philips has determined the cause was a malfunction of the vertical brake.",12/20/2012,"12/20/2012",3/20/2013,"03/20/2013"
"Food",64402,"Ongoing","Frito-Lay, Inc","Plano","TX","US","Voluntary: Firm Initiated","Other","Nationwide through grocery outlets, foodservice, and vending customers.","F-1137-2013","Class II","Sunchips 6 Grain Medley Creamy Roasted Garlic, Net WT. 9 oz. (255.1 g), UPC 2840000690","All lot codes with expiration dates prior to May 21, 2013 are impacted.",,"13, 812 cases","The products were manufacturing using flour supplied by Dakota Specialty Milling and have the potential to contain metal.",2/20/2013,"02/20/2013",3/20/2013,"03/20/2013"
"Food",64402,"Ongoing","Frito-Lay, Inc","Plano","TX","US","Voluntary: Firm Initiated","Other","Nationwide through grocery outlets, foodservice, and vending customers.","F-1138-2013","Class II","Sunchips 6 Grain Medley Parmesan & Herb, Net Wts. 9 oz (255.1 g) UPC 2840003963 and 1 3/8 oz (38.9 g) UPC 2840000892","All lot codes with expiration dates prior to May 21, 2013 are impacted.",,"33,819 cases","The products were manufacturing using flour supplied by Dakota Specialty Milling and have the potential to contain metal.",2/20/2013,"02/20/2013",3/20/2013,"03/20/2013"
"Devices",64403,"Ongoing","Philips Medical Systems (Cleveland) Inc","Cleveland","OH","US",,"Letter","Distributed only in Ohio.","Z-0897-2013","Class II","Ingenuity TF PET/CT Diagnostic imaging system ","Model # 882456, Serial # 2004.",,"1 Unit","Issues have been detected in the Ingenuity TF PET/CT currently running Ingenuity TF PET/CT system software version 4.0.0.26635 that if they were to re-occur, could cause a risk for patients.",1/21/2013,"01/21/2013",3/6/2013,"03/06/2013"
"Devices",64404,"Ongoing","Atricure Inc","West Chester","OH","US",,,"Nationwide Distribution including the states of MD, PA and TX.","Z-0912-2013","Class II","Atricure Inc. The Isolator Transpolar Pen is intended to ablate cardiac tissues during cardiac surgery using radiofrequency energy when connected to the AtriCure Ablation and Sensing Unit or for temporary cardiac pacing, sensing, recording, and stimulation during the evaluation of cardiac arrhythmias during surgery when connected to a temporary external cardiac pacemaker or recording device.","Model Number(s): MAX1 A000163, Lot Number 41865",,"5 devices","AtriCure has identified that products from lot no. 41865 may have been sent out with Incorrect Instructions for Use (IFU) labeling.",1/14/2013,"01/14/2013",3/13/2013,"03/13/2013"
"Drugs",64405,"Ongoing","Dr Reddys Laboratories Tennessee LLC","Bristol","TN","US","Voluntary: Firm Initiated","Letter","Nationwide","D-239-2013","Class II","Amoxicillin for Oral Suspension, 125mg/5mL, a) 80 mL (NDC 43598-222-80); b) 100mL, (NDC 43598-222-52); c)150 mL (NDC 43598-222-53) bottles, Rx only, Dist. By: Dr. REDDY'S Laboratories, Inc., Bridgewater, NJ 08807","Lot #s: a) T200112; b) T200103, T200113; c) T200104, T200114 ",".","4236 Bottles","Microbial Contamination of Non-Sterile Products: Suspensions made from these lots of Amoxicillin 125 mg/5 mL showed yeast and mold growth at the 14 day time point.",2/15/2013,"02/15/2013",4/10/2013,"04/10/2013"
"Devices",64406,"Ongoing","Synthes USA HQ, Inc.","West Chester","PA","US","Voluntary: Firm Initiated","Letter","Distributed in MA.","Z-2243-2013","Class II","Synthes Cannulated Distal Femoral Nail (Trauma Nail), Part Number 450.851S, 420MM-Sterile. Orthppedic implant device.","Part Number 450.851S, Lot Number 7065061",,"1","Firm discovered that a nail that was within the scope of a previous Trauma Nail recall had been distributed. ",4/18/2013,"04/18/2013",9/25/2013,"09/25/2013"
"Devices",64407,"Ongoing","Aesculap, Inc.","Center Valley","PA","US","Voluntary: Firm Initiated","Letter","USA Nationwide Distribution including the states of: AR, CA, FL, IN, IA, KS, MD, MN, MO, OR, TN, TX, VA and WA.","Z-0887-2013","Class II","Aesculap Bipolar Generator Foot Pedal, Catalog No. GK226 Product Usage: Aesculaps Bipolar Coagulator is intended for use in surgery to generate electrical power for bipolar instruments. Bipolar coagulators are used in neurosurgery, ENT surgery, urology, laparoscopy, and plastic surgery.","Manufacture date on the label on the bottom of the foot pedal - any product with manufactured dates between 45/10 and 31/12",,"59","AIC (USA) received a notification from Aesculap, AG (the manufacturer) regarding complaints that the bipolar energy did not stop after release of the foot pedal. ",1/18/2013,"01/18/2013",3/6/2013,"03/06/2013"
"Food",64408,"Ongoing","Mondelez Global Llc","East Hanover","NJ","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Nationwide and Puerto Rico","F-1069-2013","Class II","Carton:Nabisco belVita Apple Cinnamon Net Wt. 8.8 oz UPC 0 44000 02824 1 Distributed by Kraft Foods Global, Inc. Northfield, IL 60093-2753 USA Inner Pouch: Nabisco belVita Apple Cinnamon Net Wt. 1.76 oz UPC 0 44000 02825 1 Distributed by Kraft Foods Global, Inc. Northfield, IL 60093-2753 USA Shipper: Mixed ''Better For You'' Shipper UPC 00044000034023 which also contains product not subject to the recall 590 cases distributed","8 Jan 12 through 2 Sep 13",,"551,180 boxes (each case contains 6 boxes, with 5 pouches and 4 cookies in each)","Mondelez Global LLC is conducting a voluntary recall of belVita Breakfast Biscuit Apple Cinnamon and Chocolate Varieties due to the possible presence of fragments of flexible metal mesh caused by a faulty screen at third party flour supplier.",2/21/2013,"02/21/2013",3/20/2013,"03/20/2013"
"Food",64408,"Ongoing","Mondelez Global Llc","East Hanover","NJ","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Nationwide and Puerto Rico","F-1068-2013","Class II","Case UPC:144000031944 Carton: Nabisco belVita Chocolate Variety Net Wt. 8.8 oz UPC 0 44000 03194 7 Distributed by Kraft Foods Global, Inc. Northfield, IL 60093-2753 USA Inner Pouch: Nabisco belVita Chocolate Variety Net Wt. 1.76 oz UPC 0 44000 03192 3 Distributed by Kraft Foods Global, Inc. Northfield, IL 60093-2753 USA 14.08 oz Please note there are mixed shippers, shipper labels are not available: Mixed belVita Shipper UPC 0044000032784 which contains a 14.08 oz 2 pc product- waiting for label for this size. 9618 cases distributed.","21 Jan 13 through 29 Sep 13",,"460,917 cases (6 boxes in each case with 5 pouches that contain 4 cookies)","belVita breakfast biscuit may contain fragments of flexible metal mesh caused by a faulty screen at a third-party flour supplier.",2/21/2013,"02/21/2013",3/20/2013,"03/20/2013"
"Drugs",64409,"Ongoing","OLAAX International","Bartow","FL","US","Voluntary: Firm Initiated","Telephone","Nationwide, Puerto Rico and Venezuela and Bolivia","D-600-2013","Class I","MAXILOSS Weight Advanced, 225 mg proprietary blend of herbs, supplied in 36 count capsules in Green & Blue Boxes, Formulated and distributed by Olaax Corp, Lakeland, FL ","All Lots",".","600 boxes","Marketed Without an Approved NDA/ANDA: product contains sibutramine, a previously approved FDA drug removed from the U.S. marketplace for safety reasons, making it an unapproved new drug.",2/12/2013,"02/12/2013",6/19/2013,"06/19/2013"
"Devices",64410,"Ongoing","Volk Optical Inc","Mentor","OH","US",,"Letter","Worldwide Distribution - USA including the states of AZ, CA, GA, MN, NJ, and NM. Internationally to Japan.","Z-0966-2013","Class III","20 Diopter Binocular Indirect Ophthalmoscope (BIO) Lens For visualization during diagnosis and laser therapy of the human retina (fundus) using a binocular indirect ophthalmoscope.","Product Code: V20LC; Lot/Serial Numbers: BB09213 & BB09205",".","40 devices","The defect was with mis-engraving of the lot # directly on the product and its packaging. Mixed up device engraving of V20LC (lot # BB09213) with that from V60C (lot # BB09205).",10/25/2012,"10/25/2012",3/27/2013,"03/27/2013"
"Veterinary",64411,"Ongoing","Nutri-Vet, LLC","Boise","ID","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","distributed nationwide and also to Hong Kong, Malaysia, Panama, and Singapore.","V-173-2013","Class I","NutriPet Natural Chicken Fillet Strips, Item # 76-0081, Net wt. 16oz. There is NO UPC for this product. Product is labeled in parts: ''***NUTRIPET***Naturally Chicken Fillet Strips***95% Fat-Free Treats for Dogs***NET WT. 16 oz***76-0081***''.","Lot 2095 and expiration date 07/2014. ",".","672/16 oz. packages","Nutri-Pet Chicken Jerky products are recalled because they may be contaminated with Salmonella.",2/20/2013,"02/20/2013",5/29/2013,"05/29/2013"
"Veterinary",64411,"Ongoing","Nutri-Vet, LLC","Boise","ID","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","distributed nationwide and also to Hong Kong, Malaysia, Panama, and Singapore.","V-176-2013","Class I","Nutri-Vet Natural Chicken Breast Treats with Chamomile and Ginger for Dogs Helps Reduce Stress and Anxiety, has a net weight 5 oz or 15 oz. The 5 oz. package, item 50708, has the UPC 6 69125 50708 7. The 15 oz package, item 50709, has the UPC 6 69125 50709 4. Product is labeled in parts: ''***NUTRIVET*** Natural Chicken Breast Treats***with Chamomile and Ginger for Dogs Helps Reduce Stress and Anxiety***''.","5 oz. packages have lot 072214 and expiration date 07/2014. 15 oz. packages have lot 060714 and 061514 and expiration date 06/2014.",".","1992/5 oz. packages and 3466/15 oz packages","Nutri-Vet Chicken Jerky products are recalled because they may be contaminated with Salmonella.",2/20/2013,"02/20/2013",5/29/2013,"05/29/2013"
"Veterinary",64411,"Ongoing","Nutri-Vet, LLC","Boise","ID","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","distributed nationwide and also to Hong Kong, Malaysia, Panama, and Singapore.","V-181-2013","Class I","Nutri-Vet Natural Chicken Breast Treats for Dogs, 5 oz. package, Item 50701, has the UPC 6 69125 50701 8; Nutri-Vet K9 Natural Chicken Breast Treats, 8 oz. package, Item 50702, has the UPC 6 69125 50702 5; Nutri-Vet K9 Natural Chicken Breast Treats, 16 oz. package, Item 50703, has the UPC 6 69125 50703 2; Product is labeled in parts: ''***NUTRIVET*** Natural Chicken Breast Treats for Dogs***VETERINARY FORMULATED***''.","5 oz packages have lot code 072514 and expiration date 07/2014. 8 oz. packages have lot code 072514 and expiration date 07/2014. 16 oz. packages have lot code 061214 and 061414 and expiration date 06/2014/",".","1986/5 oz. Packages; 1992/8 oz. Packages; and 2016/16 oz. Packages","Nutri-Vet Chicken Jerky products are recalled because they may be contaminated with Salmonella.",2/20/2013,"02/20/2013",5/29/2013,"05/29/2013"
"Veterinary",64411,"Ongoing","Nutri-Vet, LLC","Boise","ID","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","distributed nationwide and also to Hong Kong, Malaysia, Panama, and Singapore.","V-175-2013","Class I","Nutri-Vet Natural Chicken Breast Treats with Omega 3 for Dogs Promotes a Glossy Coat has a net weight 5 oz or 15 oz. The 5 oz. package, item 50706, has the UPC 6 69125 50706 3; The 15 oz package, item 50707, has the UPC 6 69125 50707 0; Product is labeled in parts: ''***NUTRIVET***Natural Chicken Breast Treats*** with Omega 3 for Dogs Promotes a Glossy Coat***''.","5 oz. packages have lot 072314 and expiration date 07/2014. 15 oz. packages have lot 061514 and expiration date 06/2014.",".","1992/5 oz. packages and 3600/15 oz. packages","Nutri-Vet Chicken Jerky products are recalled because they may be contaminated with Salmonella.",2/20/2013,"02/20/2013",5/29/2013,"05/29/2013"
"Veterinary",64411,"Ongoing","Nutri-Vet, LLC","Boise","ID","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","distributed nationwide and also to Hong Kong, Malaysia, Panama, and Singapore.","V-180-2013","Class I","Nutri-Vet Natural Chicken Breast Treats with L-Carnitine for Dogs Promotes Healthy Weight. The net weight is 5 oz, item number is 50716. The UPC is 6 69125 50716 2. Product is labeled in parts: ''***NUTRIVET*** Natural Chicken Breast Treats*** with L-Carnitine for Dogs Promotes Healthy Weight.***''.","lot number 072514 and expiration date 07/2014",".","1992/5 oz. Packages","Nutri-Vet Chicken Jerky products are recalled because they may be contaminated with Salmonella.",2/20/2013,"02/20/2013",5/29/2013,"05/29/2013"
"Veterinary",64411,"Ongoing","Nutri-Vet, LLC","Boise","ID","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","distributed nationwide and also to Hong Kong, Malaysia, Panama, and Singapore.","V-174-2013","Class I","Nutri-Vet Natural Chicken Breast Treats with Glucosamine for Dogs Promotes Joint Health, has net weight 5 oz or 15 oz. The 5 oz. package, item 50704, has the UPC 6 69125 50704 9. The 15 oz package, item 50705, has the UPC 6 69125 50705 6. Product is labeled in parts: ''***NUTRIVET***Naturally Chicken Breast Treats***with glucosamine for Dogs Promote Joint Health***''.","5 oz packages have lot 072114 and expiration date 07/2014. 15 oz. packages have lot 061114 and 061514 and expiration date 06/2014.",".","1992/5 oz. Packages and 3576/15 oz. Packages","Nutri-Vet Chicken Jerky products are recalled because they may be contaminated with Salmonella.",2/20/2013,"02/20/2013",5/29/2013,"05/29/2013"
"Veterinary",64411,"Ongoing","Nutri-Vet, LLC","Boise","ID","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","distributed nationwide and also to Hong Kong, Malaysia, Panama, and Singapore.","V-178-2013","Class I","Nutri-Vet Natural Chicken Breast Treats with Antioxidants for SENIOR Dogs Promotes Health and Vitality. Item number is 50712 and has net weight 5 oz. The UPC is 6 69125 50712 4 Product is labeled in parts: ''***NUTRIVET*** Natural Chicken Breast Treats*** Antioxidants for SENIOR dogs Promotes Health and Vitality***''.","Lot number 062914 and expiration date 06/2014",".","1992/5 oz. Packages","Nutri-Vet Chicken Jerky products are recalled because they may be contaminated with Salmonella.",2/20/2013,"02/20/2013",5/29/2013,"05/29/2013"
"Veterinary",64411,"Ongoing","Nutri-Vet, LLC","Boise","ID","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","distributed nationwide and also to Hong Kong, Malaysia, Panama, and Singapore.","V-179-2013","Class I","Nutri-Vet Natural Chicken Breast Treats with Enzymes for Dogs Promotes Healthy Digestion. Item number is 50714, net weight 5 oz, and the UPC is 6 69125 50714 8. Product is labeled in parts: ''***NUTRIVET*** Natural Chicken Breast Treats with Enzymes for Dogs Promotes Healthy Digestion***''.","lot number 072614 and expiration date 07/2014",".","1992/5 oz. Packages","Nutri-Vet Chicken Jerky products are recalled because they may be contaminated with Salmonella.",2/20/2013,"02/20/2013",5/29/2013,"05/29/2013"
"Veterinary",64411,"Ongoing","Nutri-Vet, LLC","Boise","ID","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","distributed nationwide and also to Hong Kong, Malaysia, Panama, and Singapore.","V-182-2013","Class I","Nutri-Vet Hip & Joint Natural Chicken Breast Strips, 100 mg glucosamine per oz. Product has item number 99044, net weight of 8 oz, and the UPC is 6 69125 99044 5. Product is labeled in parts: ''***NUTRIVET*** Natural Chicken Breast STRIPS***Early care for dogs***100 mg glucosamine per oz***Hip & Joint***''.","lot code 072714 and expiration date 07/2014",".","1728/8 oz. Packages","Nutri-Vet Chicken Jerky products are recalled because they may be contaminated with Salmonella.",2/20/2013,"02/20/2013",5/29/2013,"05/29/2013"
"Veterinary",64411,"Ongoing","Nutri-Vet, LLC","Boise","ID","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","distributed nationwide and also to Hong Kong, Malaysia, Panama, and Singapore.","V-177-2013","Class I","Nutri-Vet Natural Chicken Breast Treats with Rosemary and Parsley for Dogs Promotes Fresh Breath, has a net weight 5 oz or 15 oz. The 5 oz. package, item 50710, has the UPC 6 69125 50710 0. The 15 oz package, item 50711, has the UPC 6 69125 50711 7. Product is labeled in parts: ''***NUTRIVET*** Natural Chicken Breast Treats*** with Rosemary and Parsley for Dogs Promotes Fresh Breath***''.","5 oz. packages have lot 072314 and expiration date 07/2014. 15 oz. packages have lot 060714 and 060814 and expiration date 06/2014.",".","1992/5 oz Packages and 3095/15 oz. Packages","Nutri-Vet Chicken Jerky products are recalled because they may be contaminated with Salmonella.",2/20/2013,"02/20/2013",5/29/2013,"05/29/2013"
"Food",64412,"Ongoing","Bimbo Bakeries Usa","Horsham","PA","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Nationwide distribution.","F-1220-2013","Class II","Farm Bread All Natural Multi-Grain, NET WT 24 OZ (1 LB 8 OZ) 680g","Best by dates prior to and including Feb 20",".",,"Firm has initiated a voluntary recall due to the possible presence of flexible wire caused by a faulty screen at a third party flour mill that supplied flour used in the manufacture of the recalled products.",2/19/2013,"02/19/2013",3/27/2013,"03/27/2013"
"Food",64412,"Ongoing","Bimbo Bakeries Usa","Horsham","PA","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Nationwide distribution.","F-1214-2013","Class II","Stroehmann Dutch Country 100% Whole Grain Bread, 1 LB 8 OZ (680g)","Best by dates prior to and including Feb 20 ",".",,"Firm has initiated a voluntary recall due to the possible presence of flexible wire caused by a faulty screen at a third party flour mill that supplied flour used in the manufacture of the recalled products.",2/19/2013,"02/19/2013",3/27/2013,"03/27/2013"
"Food",64412,"Ongoing","Bimbo Bakeries Usa","Horsham","PA","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Nationwide distribution.","F-1215-2013","Class II","Aldi L'Oven Fresh Hearty 12 Grain Bread, NET WT 24 OZ (1 LB 8 OZ) 680g","Best by dates prior to and including Feb 20 ",".",,"Firm has initiated a voluntary recall due to the possible presence of flexible wire caused by a faulty screen at a third party flour mill that supplied flour used in the manufacture of the recalled products.",2/19/2013,"02/19/2013",3/27/2013,"03/27/2013"
"Food",64412,"Ongoing","Bimbo Bakeries Usa","Horsham","PA","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Nationwide distribution.","F-1217-2013","Class II","Brownberry Grains & More Double Protein Bread, 1 LB 8 OZ (680g)","Best by dates prior to and including Feb 20 ",".",,"Firm has initiated a voluntary recall due to the possible presence of flexible wire caused by a faulty screen at a third party flour mill that supplied flour used in the manufacture of the recalled products.",2/19/2013,"02/19/2013",3/27/2013,"03/27/2013"
"Food",64412,"Ongoing","Bimbo Bakeries Usa","Horsham","PA","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Nationwide distribution.","F-1210-2013","Class II","Brownberry Healthfull 45 Calories Per Slice Multigrain Bread, 1 LB 2 OZ (510g)","Best by dates prior to and including Feb 20 ",".",,"Firm has initiated a voluntary recall due to the possible presence of flexible wire caused by a faulty screen at a third party flour mill that supplied flour used in the manufacture of the recalled products.",2/19/2013,"02/19/2013",3/27/2013,"03/27/2013"
"Food",64412,"Ongoing","Bimbo Bakeries Usa","Horsham","PA","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Nationwide distribution.","F-1221-2013","Class II","Harmons 100% Multi-Grain Wide Pan Oven-Baked Bread, NET WT 24 OZ (1LB 8 OZ) 680g","Best by dates prior to and including Feb 20",".",,"Firm has initiated a voluntary recall due to the possible presence of flexible wire caused by a faulty screen at a third party flour mill that supplied flour used in the manufacture of the recalled products.",2/19/2013,"02/19/2013",3/27/2013,"03/27/2013"
"Food",64412,"Ongoing","Bimbo Bakeries Usa","Horsham","PA","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Nationwide distribution.","F-1213-2013","Class II","Arnold Healthfull 45 Calories Per Slice Multigrain Bread, 1 LB 2 OZ (510g)","Best by dates prior to and including Feb 20 ",".",,"Firm has initiated a voluntary recall due to the possible presence of flexible wire caused by a faulty screen at a third party flour mill that supplied flour used in the manufacture of the recalled products.",2/19/2013,"02/19/2013",3/27/2013,"03/27/2013"
"Food",64412,"Ongoing","Bimbo Bakeries Usa","Horsham","PA","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Nationwide distribution.","F-1212-2013","Class II","Brownberry Dutch Country 100% Whole Grain Bread, 1 LB 8 OZ (680g)","Best by dates prior to and including Feb 20 ",".",,"Firm has initiated a voluntary recall due to the possible presence of flexible wire caused by a faulty screen at a third party flour mill that supplied flour used in the manufacture of the recalled products.",2/19/2013,"02/19/2013",3/27/2013,"03/27/2013"
"Food",64412,"Ongoing","Bimbo Bakeries Usa","Horsham","PA","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Nationwide distribution.","F-1219-2013","Class II","Earthgrains 12 Grain Natural Bread, NET WT 1 LB 8 OZ (680g)","Best by dates prior to and including Feb 20",".",,"Firm has initiated a voluntary recall due to the possible presence of flexible wire caused by a faulty screen at a third party flour mill that supplied flour used in the manufacture of the recalled products.",2/19/2013,"02/19/2013",3/27/2013,"03/27/2013"
"Food",64412,"Ongoing","Bimbo Bakeries Usa","Horsham","PA","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Nationwide distribution.","F-1216-2013","Class II","Brownberry Healthfull Nutty Grain Bread, 1 LB 8 OZ (680g)","Best by dates prior to and including Feb 20 ",".",,"Firm has initiated a voluntary recall due to the possible presence of flexible wire caused by a faulty screen at a third party flour mill that supplied flour used in the manufacture of the recalled products.",2/19/2013,"02/19/2013",3/27/2013,"03/27/2013"
"Food",64412,"Ongoing","Bimbo Bakeries Usa","Horsham","PA","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Nationwide distribution.","F-1218-2013","Class II","Sara Lee 12 Grain Bread Hearty & Delicious, 24 OZ (1LB 8OZ) 680g ","Best by dates prior to and including Feb 17 ",".",,"Firm has initiated a voluntary recall due to the possible presence of flexible wire caused by a faulty screen at a third party flour mill that supplied flour used in the manufacture of the recalled products.",2/19/2013,"02/19/2013",3/27/2013,"03/27/2013"
"Food",64412,"Ongoing","Bimbo Bakeries Usa","Horsham","PA","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Nationwide distribution.","F-1211-2013","Class II","Arnold Dutch Country 100% Whole Grain Bread, 1 LB 8 OZ (680g)","Best by dates prior to and including Feb 20 ",".",,"Firm has initiated a voluntary recall due to the possible presence of flexible wire caused by a faulty screen at a third party flour mill that supplied flour used in the manufacture of the recalled products.",2/19/2013,"02/19/2013",3/27/2013,"03/27/2013"
"Food",64412,"Ongoing","Bimbo Bakeries Usa","Horsham","PA","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Nationwide distribution.","F-1222-2013","Class II","Sara Lee Multi-Grain Thin Style Buns, NET WT 12 OZ (340g)","Best by dates prior to and including Feb 17 ",".",,"Firm has initiated a voluntary recall due to the possible presence of flexible wire caused by a faulty screen at a third party flour mill that supplied flour used in the manufacture of the recalled products.",2/19/2013,"02/19/2013",3/27/2013,"03/27/2013"
"Biologics",64414,"Terminated","Bio-Blood Components, Inc.","Hammond","IN","US","Voluntary: Firm Initiated","FAX","California","B-1183-13","Class II","Source Plasma","12HINC8697; ",".","1","Blood product, collected from a donor who was suspected of receiving a piercing within 12 months of donating, was distributed.",1/21/2013,"01/21/2013",6/19/2013,"06/19/2013"
"Biologics",64415,"Terminated","BloodCenter of Wisconsin, Inc","Milwaukee","WI","US","Voluntary: Firm Initiated","FAX","Wisconsin; Arkansas","B-1184-13","Class II","Platelets Pheresis Leukocytes Reduced","W036312107843; W036312107843; W036312107843; ",".","3","Blood products, collected from a donor who was taking Plavix, were distributed.",1/17/2013,"01/17/2013",6/19/2013,"06/19/2013"
"Drugs",64416,"Ongoing","Humco Holding Group, Inc","Texarkana","TX","US","Voluntary: Firm Initiated","Letter","Nationwide","D-197-2013","Class II","Mercuroclear Antiseptic Anesthetic First Aid Helps prevent infection and relieves pain and itching of minor cuts, scrapes, burns and insect bites. Active Ingredients Benzalkonium chloride 0.13% - First Aid antiseptic, Lidocaine hydrochloride 2.5% - External analgesic, Sold under the following brands: a) Good Neighbor Pharmacy, NDC 24385-593-46; b) Quality Choice, NDC 63868-0488-02; c) Select Brand NDC 15127-885-59; d) Premier Value; e) CVS Pharmacy; f) Rite Aid Pharmacy; g) Top Care; h) HEB; and i) Humco.","a) Good Neighbor, Item Number 163792006: Lot #s: 534204, 538468, 540540; b) Quality Choice, Item Number 163792066: Lot #s: 538835, 539431; c) Select Brands, Item Number 163792067: Lot #: 540529; d) Premier Value, Item Number 163792079: Lot #s: 534545 and 535307; e) CVS, Item Number 163791091 (1 oz.): Lot #s 533472, 534055, 534256, 534546, 534995, 535249, 535318, 535683, 536302, 537285, 538138, 538189, 538439, 538672; and Item Number 163792091 (2 oz.): Lot #s: 538408, 540530, 540542, 540712; f) Rite Aid, Item Number 163792088: Lot #s: 533471, 534067, 534337, 534548, 535512, 535876, 536526, 537076, 537284, 538229, 538469, 538864, 539475, 540714, 541285, 541304, 541415, 541672; g) Top Care, Item Number 163792101: Lot #: 535070, 535681, 537323, 537376, and 537587; h) H.E.B, Item Number 163793800: Lot #s: 534442, 534701, 534981, 535332, 535403, 536300; and i) HUMCO, Item Number 163792001, 163792015 (2 oz.): Lot #s 534612, 534767, 535402, 535845, 536899, 537335, 537586, 538219, 538470, 538865, 539691, 539803, 539845, 541193 and 533470, 533554, 534032, 534057, 534158, 534399, 534547, 534686, 535069, 535246, 535317, 535682, 535874, 536247, 536301, 536900, 537075, 537283, 537588, 537722, 537960, 538190, 538191, 538289, 538410, 538671, 538673, 539640, 539692, 540143, 540144, 540176, 540539, 540713, 540820, 540851, 541101, 541146, 541195, 541611, 541673; and Item Number 163793001 (3 oz.): Lot #s: 534165, 534748, 535404, 537751, 539387, 540029, 540296, 540711. ",,"1,269,846 bottles","Microbial Contamination of Non-Sterile Product(s): The product has the potential to be contaminated with Bulkholderia gladioli.",1/17/2013,"01/17/2013",3/20/2013,"03/20/2013"
"Devices",64417,"Ongoing","Medtronic Inc. Cardiac Rhythm Disease Management","Saint Paul","MN","US","Voluntary: Firm Initiated","Letter","Worldwide distribution, including USA nationwide, Albania, Algeria, Argentina, Australia, Austria, Belgium, Brazil, Canada, Chile, Colombia, Croatia, Cyprus, Czech Republic, Denmark, Ecuador, Egypt, Finland, France, Germany, Greece, Guatemala, Hong Kong, Hungary, India, Indonesia, Ireland, Israel, Italy, Jamaica, Japan, Kazakhstan, Korea, Libya, Lithuania, Macedonia, Malaysia, Mexico, Morocco, Netherlands, New Zealand, Norway, Peru, Philippines, Poland, Portugal, Qatar, Romania, Russian Federation, Saudi Arabia, Singapore, South Africa, Spain, Sweden, Switzerland, Taiwan, Thailand, Turkey, United Kingdom, and Viet Nam.","Z-0908-2013","Class II","Medtronic DPL Single Stage Venous Cannula with Metal Tip, used in cardiopulmonary bypass procedures. Model numbers: 67312; 67314; CB67314; 67316; 67318; CB67318; 67320; 69312; 69314; 69316; 69318; 69320; 69322; 69324; 69328; 69331. ","Model Catalog# Lot67312 6731210NO 2012090293 67312 6731210NO 2012090294 67312 6731210NO 2012090337 67312 6731210NO 2012100039 67312 6731210NO 2012100086 67312 6731210NO 2012100087 67312 6731210NO 2012100161 67312 6731210NO 2012110326 67312 6731210NO 2012110767 67312 6731210NO 2012110899 67312 6731210NO 2012111721 67314 6731410NO 2012090416 67314 6731410NO 2012090435 67314 6731410NO 2012090571 67314 6731410NO 2012090572 67314 6731410NO 2012100040 67314 6731410NO 2012100041 67314 6731410NO 2012100107 67314 6731410NO 2012101346 67314 6731410NO 2012110007 67314 6731410NO 2012110008 67314 6731410NO 2012110327 67314 6731410NO 2012111419 67314 6731410NO 2012111420 67314 6731410NO 2012120019 67316 6731610NO 2012090239 67316 6731610NO 2012090389 67316 6731610NO 2012090854 67316 6731610NO 2012091024 67316 6731610NO 2012110030 67316 6731610NO 2012110144 67316 6731610NO 2012110394 67316 6731610NO 2012110395 67316 6731610NO 2012110396 67318 67318 2012110850 67318 67318 2012110851 67318 67318 2012111013 67318 67318 2012111789 67318 67318 2012120328 67318 67318 2012120330 67318 67318 2013010932 67318 67318 2013010933 67318 67318 2013011226 67320 67320 2012121379 67320 67320 2012121629 67320 67320 2013010002 67320 67320 2013010105 69312 6931210NO 2012090236 69312 6931210NO 2012110010 69312 69312INK 2012090296 69312 69312INK 2012100905 69312 69312INK 2012110251 69312 69312INK 2012110252 69314 6931410NO 2012090855 69314 6931410NO 2012091222 69316 6931610NO 2012090240 69318 69318 2012111225 69318 69318 2013010966 69320 69320 2012121408 69320 69320 2013010003 69322 69322 2012111723 69322 69322 2012120118 69322 69322 2012120513 69322 69322 2013010812 69322 69322 2013010935 69324 69324 2012121060 69324 69324 2012121061 69324 69324 20121210",,"13,691 (6711 USA; 6980 OUS)","Potential for uncharacteristically rough metal edges to occur along the inner diameter of the metal tip side ports of the cannula.",2/19/2013,"02/19/2013",3/13/2013,"03/13/2013"
"Devices",64418,"Ongoing","Thermo Fisher Scientific (Asheville) LLC","Marietta","OH","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution - USA (nationwide) including the states of: AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, PR, RI, SC, SN, TN, TX, UT, VA, VT, WA, WI, WV & WY. and the countries: AFGHANISTAN, ARGENTINA, AUSTRALIA, AUSTRIA, BELARUS, BELGIUM, BRAZIL, CANADA, CHILE, COSTA RICA, DENMARK, EGYPT, ENGLAND, FINLAND, FRANCE, GERMANY, GREECE, HONG KONG, ICELAND, INDIA, INDONESIA, IRELAND, ISRAEL, ITALY, JAMAICA, JAPAN, JORDAN, KOREA, LEBANON, MALAYSIA, MEXICO, NEPAL, NETHERLANDS, NEW ZEALAND, NORWAY, PALESTINE, PEOPLES REPUBLIC OF CHINA, PERU, PHILIPPINES, PORTUGAL, QATAR, REPUBLIC OF PANAMA, ROMANIA, SINGAPORE, SOUTH AFRICA, SPAIN, SWEDEN, SWITZERLAND, TAIWAN, THAILAND, TUNISIA, TURKEY, UNITED ARAB EMIRATES, VENEZUELA, VIETNAM & WEST INDIES.","Z-1079-2013","Class II","CO2 Incubators (General Purpose Incubator), model numbers 370, 371, 380, 381, 3307, 3308, 3310, 3311, 3540, 3541, 3542, 3543, 3584, 3585, 3598, and 3599. Product Usage: Incubators are designed to maintain an optimal environment for the incubation of tissue and cell samples. These models are designed to maintain temperature, carbon dioxide, and humidity levels. ","300028-325 to 30028-326; 300031-327 to 30031-331; 300111-332 to 30011-350; 300112-351 to 300112-365; 300113-366 to 300113-379; 300114-380 to 300114-383; 300208-386 to 300208-390; 300208-392 to 300208-397; 300209-398 to 300209-404; 300209-406 to 300209-411; 300210-412 to 300210-422; 300210-424; 300211-426 to 300211-444; 300285-445 to 300285-458; 300287-459 to 300287-466; 300288-467 to 300288-480; 300382-481 to 300382-494; 300383-495 to 300383-508; 300384-509 to 300384-522; 300385-523 to 300385-526; 300473-527 to 300473-531; 300474-532 to 300474-541; 300475-542 to 300475-551; 300476-552 to 300476-553; 3000551-384 to 300551-385; 300581-554 to 300581-563; 300583-564 to 300583-580; 300584-581 to 300584-600; 300670-601 to 300670-610; 300671-611 to 300671-624; 300672-625 to 300672-638; 300748-639 to 300748-650; 300749-651; 300750-653 to 300750-655; 300751-656 to 300751-659; 300840-660 to 300840-663; 300841-664 to 300841-667; 300842-668 to 300842-677; 300842-679 to 300842-683; 300843-684 to 300843-697; 300925-698 to 300925-707; 300925-709 to 300925-711; 300926-712 to 300926-725; 300927-726 to 300927-739; 300928-740 to 300928-751; 301005-752 to 301005-764; 301006-765 to 301006-781; 301007-782 to 301007-798; 301008-799 to 301008-814; 301080-815 to 301080-827; 301081-828 to 301081-837; 301082-838 to 301082-845; 301083-846 to 301083-857; 301204-858 to 301204-861; 301204-863: 301204-865 to 301204-867; 301204-871; 301205-872 to 301205-873; 301205-875 to 301205-884; 301206-885 to 301206-897; 301306-898 to 301306-907; 301391-908; 301391-911; 301391-914 to 301391-917; 301393-1032 to 301393-1039; 301479-918; 301480-919 to 301480-926; 301481-927 to 301481-932; 301584-933 to 301584-955; 301585-956 to 301585-971; 301586-972 to 301586-983; 301587-984 to 301587-994; 301678-1000 to 301678-1004; 301678-995 to 301678-999; 301679-1005 to 301679-1007; 301680-1008 to 301680-1010; 301771-1011 to 301771-1012; 301772-1013 to 301772-1017; 301773-1018 to 301773-1019; 301774-1026 to 301774-1031; 301795-1040 to 301795-1052; 301796-1053 to 301796"," 315140-784; 48564-6; 49169-7 to 49169-10; 49172-11 to 49172-14; 49176-15 to 49176-17; 49179-18 to 49179-24; 49182-25 to 49182-28; 49188-29 to 49188-31; 49195-32 to 49195-34; 49198-35 to 49198-38; 55665-47 to 55665-53; 58387-39 to 58387-40; 60651-41 to 60651-42; 60653-43 to 60653-44; 61263-54 to 61263-56; 61777-71 to 61777-73; 61778-77 to 61778-79; 61779-83 to 61779-84; 62426-85; 62428-86 to 62428-87. Model 3307: Serial #'s: 301141-10 to 301141-12; 301159-74 to 301159-77; 301171-17 to 301171-22; 301172-23 to 301172-30; 301246-31 to 301246-36; 301247-37 to 301247-42; 301278-13 to 301278-16; 301345-43 to 301345-44; 301346-45 to 301346-48; 301347-49 to 301347-56; 301431-61 to 301431-62; 301432-63; 301433-65 to 301433-72; 301519-78 to 301519-81; 301521-82 to 301521-85; 301625-86 to 301625-89; 301627-90 to 301627-93; 301719-94 to 301719-95; 301721-96 to 301721-99; 301742-57 to 301742-60; 301757-100 to 301757-103; 301836-104 to 301836-107; 301838-108 to 301838-111; 301867-73; 301929-112 to 301929-115; 301930-116 to 301930-119; 302022-120 to 302022-123; 302107-124 to 302107-127; 302108-128 to 302108-131; 302198-138 to 302198-141; 302281-142 to 302281-145; 302282-146 to 302282-157; 302378-158 to 302378-167; 302379-178 to 302379-181; 302481-182 to 302481-183; 302482-188 to 302482-191; 302529-132 to 302529-137; 302584-192 to 302584-195; 302585-196 to 302585-197; 302608-184 to 302608-187; 302615-168 to 302615-177; 302671-198 to 302671-201; 302672-208 to 302672-211; 302766-212 to 302766-215; 302767-222 to 302767-225; 302796-230 to 302796-233; 302797-234 to 302797-237; 302798-242 to 302798-245; 302799-246 to 302799-249; 302800-250 to 302800-253; 302807-254 to 302807-257; 302808-258 to 302808-261; 302809-262 to 302809-265; 302880-266 to 302880-273; 302881-274 to 302881-277; 302882-278 to 302882-281; 302904-202 to 302904-207; 302905-216 to 302905-221; 302978-282 to 302978-285; 302979-292 to 302979-295; 302980-296 to 302980-299; 303085-300 to 303085-303; 303086-304 to 303086-307; 303087-308 to 303087-311; 303110-226 to 303110","15,567 incubators","Incubators manufactured prior to mid 2009 have coated metal hinges that have reportedly failed in the field.",11/29/2012,"11/29/2012",4/17/2013,"04/17/2013"
"Food",64419,"Ongoing","Herbalife International Of America Inc","Torrance","CA","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Worldwide distribution","F-1059-2013","Class I","HERBALIFE Formula 1 Instant Healthy Meal, Nutritional Shake Mix ( Vanilla Dream) Packets; net WT 1.83 oz/52 g; packaged as 12 packets in a cardboard carton; just add water; single serve powder in a packet;","Lot #'s 133405G10; 133407G10; 133407C10; 133408C10; 133408G10; 133409C10; 133409G10; 133411L10; 133410L10; 133410J10;133412L10; 133410M11; 133410K07; 133411M11; 133412M11; 133418R10; Catalogue #2797; NNPart #'s: 68-00033; 68-00037; 68-00032; 68-00031; 68-00092.",,"5,928 (2,732 cartons and3,196 IBP Kits)","Herbalife of America Inc is initiating this recall due to trace amounts of an undeclared milk protein allergen.",2/20/2013,"02/20/2013",3/13/2013,"03/13/2013"
"Devices",64420,"Ongoing","Covidien LP","North Haven","CT","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution -- USA, Asia Pacific, Canada, Europe, and Japan.","Z-1063-2013","Class II","Covidien Endo GIA AutoSuture Universal Loading Unit, 30mm-2.0mm Product Code: 030450 Applications in abdominal, gynecologic, pediatric anti thoracic surgery for resection, transection and creation of anastomosis. ","Lot Codes:N2F0563LX, N2F0341LX, N2F0725LX, and N2E0605LX.",,"6,751 units","Single Use Loading Unit contained two staples loaded in each cartridge pocket and may result in difficulty firing and removing the device from the application site, which may require medical intervention",2/11/2013,"02/11/2013",4/17/2013,"04/17/2013"
"Devices",64421,"Ongoing","Genesys Orthopedic Systems, LLC","Austin","TX","US","Voluntary: Firm Initiated","Letter","USA Nationwide Distribution including the states of: CA and TX.","Z-0921-2013","Class II","3.75mm x 12mm Fixed Cervical Screws. Components of the Genesys Spine Anterior Cervical Plate System Product Usage: is intended for anterior screw fixation to the cervical spine.","Part Number: GCSF37512 and Lot Number: 0243",,"9 cervical screws","Manufacturing residue may be present on the cervicalscrews. Use of this product may result in patient infection, delayed fusion or non-fusion (pseudarthrosis), inflammatory response, or revision surgery.",2/20/2013,"02/20/2013",3/20/2013,"03/20/2013"
"Food",64422,"Ongoing","NBTY Inc.","Bohemia","NY","US","Voluntary: Firm Initiated","Letter","Nationwide","F-1224-2013","Class III","MET-Rx EXTREME NOS PUMPED DOUBLE BERRY Naturally and Artificially Flavored DIETARY SUPPLEMENT, 20 FL. OZ. (1.25 PT) (591 mL), UPC 7 49826 35909 0, Label Revision 01C, Item Number 35909 (Bottle) Item Number 35910 (case) --- Manufactured in the USA by MET-Rx Nutrition, Inc. Boca Raton, FL 33487","Lot # 470645, exp. 11/30/2013",".","5412 bottles","The color, odor, and taste of the products are changing and do not meet the firm's high quality standards. This is an issue of commercial spoilage. ",1/18/2013,"01/18/2013",3/27/2013,"03/27/2013"
"Food",64422,"Ongoing","NBTY Inc.","Bohemia","NY","US","Voluntary: Firm Initiated","Letter","Nationwide","F-1225-2013","Class III","MET-Rx EXTREME NOS PUMPED NITRO-PUNCH Naturally Flavored DIETARY SUPPLEMENT, 20 FL. OZ. (1.25 PT) (591 mL), UPC Code 7 49826 00512 6, Label Revision 05D, Item Number 48515 --- Manufactured in the USA by MET-Rx Nutrition, Inc. Boca Raton, FL 33487","Lot 469477, exp. 11/30/2013",".","1176 bottles","The color, odor, and taste of the products are changing and do not meet the firm's high quality standards. This is an issue of commercial spoilage. ",1/18/2013,"01/18/2013",3/27/2013,"03/27/2013"
"Food",64422,"Ongoing","NBTY Inc.","Bohemia","NY","US","Voluntary: Firm Initiated","Letter","Nationwide","F-1223-2013","Class III","MET-Rx EXTREME NOS PUMPED WATERMELON Naturally and Artificially Flavored DIETARY SUPPLEMENT, 20 FL. OZ. (1.25 PT) (591 mL), UPC 7 49826 27603 8, Label Revision 02C, Item Number 27603 (Bottle) Item Number 27604 (case) --- Manufactured in the USA by MET-Rx Nutrition, Inc. Boca Raton, FL 33487","Lot 460259, exp. 10/31/2013; Lot 464764, exp. 12/31/2013 ",".","28,068 bottles","The color, odor, and taste of the products are changing and do not meet the firm's high quality standards. This is an issue of commercial spoilage. ",1/18/2013,"01/18/2013",3/27/2013,"03/27/2013"
"Devices",64423,"Ongoing","Symbios Medical Products, LLC","Indianapolis","IN","US","Voluntary: Firm Initiated","Letter","Nationwide Distribution including PA, CA, OH, AL, FL, WV, TN, NJ, NC, TX, CO, NY, TX, MO, MS, SC, and GA.","Z-0940-2013","Class I","GOPump Elastometric infusion PumpKit with/ and without accesssories all containing Dual GOPump, part number 510076: One infusion pump comprising two, 150 mL elastomeric reservoirs, each of which connects to its own catheter. Liquid flow rate is labeled at 2 mL/hr per elastomer. The Symbios Disposable Infusion Pump Kit is a disposable, self-contained infusion system utilizing an inflatable elastomeric reservoir to mechanically provide percutaneous infusion of prescribed solutions at a pre-set rate for post-operative pain management","Kit Part Number 510545-BP, lot 12-100983, 12-100984, 12-101096, 12-101125 Kit Part Number 510112-BP, lot 12-101110, 12-101103 Kit: 510401-BP lot 12-101045 Kit: 510644, lot 12-101028, 12-101097, 12-101130 GOPump Dual Infusion Pump Kit All Kits contain Pump Part Number: 510076 Lot Number: 12-100601 ",,"458","Received 2 complaints out of 458 distributed pumps in this lot, where flow restrictor bead became displaced, which were reported to permit fast flow of contents.",2/25/2013,"02/25/2013",3/20/2013,"03/20/2013"
"Devices",64424,"Ongoing","Zimmer, Inc.","Warsaw","IN","US","Voluntary: Firm Initiated","Letter","Worldwide distribution: USA (nationwide) including states of: AL, AR, AZ, CA, CT, FL, HI, IL, KY, MA, MD, MN, MO, NE, NJ, NY, OH, OK, PA, TN, TX, WA, and WI; and country of Canada.","Z-1546-2013","Class II","Zimmer Patient Helper Bed Frame Adapter Assembly The bed frame adapter assembly is intended to be used by qualified medical professionals to adapt a patient helper to a hospital bed. The patient helper is used to aid and assist the patient's mobility within a hospital bed and during bed ingress and egress.","Part number 00-0965-002-01",,"344 Units","The bed frame adapter assemblies may have a weak weld where the patient helper adapter mounting bars attach to the tube.",2/14/2013,"02/14/2013",6/26/2013,"06/26/2013"
"Devices",64425,"Ongoing","Bard Access Systems","Salt Lake City","UT","US","Voluntary: Firm Initiated","Letter","USA Nationwide Distribution and the countries Europe, Belgium, Australia, and Latin America.","Z-0910-2013","Class II","Leonard 10.0 French Dual Lumen Catheter with SureCuff Tissue Ingrowth Cuff with Peel-Apart Percutaneous Introducer system (product code 0600630). Product Usage: Hickman and Leonard Catheters are designed for long-term vascular access and for use in patients that lack adequate peripheral venous access. ","Lot numbers: HUWI1379 and HUWI1380.",,"73 units","Bard Access Systems is recalling two lots of Hickman 9.0 French and one lot of Leonard 10.0 French Dual Lumen Catheters with SureCuff Tissue Ingrowth Cuff with Peel-Apart Percutaneous Introducer Systems due to the wrong size introducer being included with the kit. ",2/21/2013,"02/21/2013",3/13/2013,"03/13/2013"
"Devices",64425,"Ongoing","Bard Access Systems","Salt Lake City","UT","US","Voluntary: Firm Initiated","Letter","USA Nationwide Distribution and the countries Europe, Belgium, Australia, and Latin America.","Z-0909-2013","Class II","Hickman 9.0 French Dual Lumen Catheter with SureCuff Tissue Ingrowth Cuff with Peel-Apart Percutaneous Introducer system (pediatric product code 0600580; adult product code 0600600). Product Usage: Hickman and Leonard Catheters are designed for long-term vascular access and for use in patients that lack adequate peripheral venous access. ","Lot numbers: HUWI1379 and HUWI1380.",,"195 units.","Bard Access Systems is recalling two lots of Hickman 9.0 French and one lot of Leonard 10.0 French Dual Lumen Catheters with SureCuff Tissue Ingrowth Cuff with Peel-Apart Percutaneous Introducer Systems due to the wrong size introducer being included with the kit. ",2/21/2013,"02/21/2013",3/13/2013,"03/13/2013"
"Food",64426,"Terminated","Kettle Foods, Inc.","Salem","OR","US","Voluntary: Firm Initiated","E-Mail","Product was distributed to 7 US consignees and 4 Canadian consignees.","F-1266-2013","Class III","Item #1900 Kettle Brand Honey Roast Nuts and Fruit Trail Mix UPC 8411401900 Label reads in part ''8411401900 Honey Roast Nuts & Fruit Mix Net Weight 24 Lbs. ***''","26 MAY12 through 02APR13",,"2866 cases","Dried pineapple which contains sulfur dioxide was accidently used to manufacturer the trail mix. The formula calls for untreated dried pineapple.",2/15/2013,"02/15/2013",4/3/2013,"04/03/2013"
"Food",64426,"Terminated","Kettle Foods, Inc.","Salem","OR","US","Voluntary: Firm Initiated","E-Mail","Product was distributed to 7 US consignees and 4 Canadian consignees.","F-1265-2013","Class III","Item #1815, Kettle brand Natural Chocolate Lovers Trail MixUPC 8411401910 Label reads in part ''8411401910 Honey Roast Harvest Mix Net Weight 24 Lbs. ***''","03JUL12 through 15JUN13",,"2731 cases","Dried pineapple which contains sulfur dioxide was accidently used to manufacturer the trail mix. The formula calls for untreated dried pineapple.",2/15/2013,"02/15/2013",4/3/2013,"04/03/2013"
"Food",64426,"Terminated","Kettle Foods, Inc.","Salem","OR","US","Voluntary: Firm Initiated","E-Mail","Product was distributed to 7 US consignees and 4 Canadian consignees.","F-1267-2013","Class III","Item #1910 Kettle brand Honey Roast Harvest trail mix UPC 8411401910Label reads in part ''8411401910 Honey Roast Harvest Mix Net Weight 24 Lbs.***''","Best Before 27JUN12 through 09JUN13",,"1943 cases","Dried pineapple which contains sulfur dioxide was accidently used to manufacturer the trail mix. The formula calls for untreated dried pineapple.",2/15/2013,"02/15/2013",4/3/2013,"04/03/2013"
"Devices",64427,"Ongoing","Physio Control, Inc.","Redmond","WA","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution.","Z-1082-2013","Class II","The LIFEPAK CR Plus and LIFEPAK EXPRESS defibrillators. Product part's numbers: 3200731-xxx, 3202177-xxx, U3200731-xxx, and U3202177-006. Automated external defibrillators. ","33219251, 33220310, 33220344, 33220367, 33220369, 33220376, 33220402, 33220450, 33220461, 33220464, 33220466, 33220470, 33221200, 33221394, 33231481, 33231486, 33231488, 33231492, 33231511, 33231512, 33231521, 33231523, 33231524, 33231527, 33231532, 33231535, 33231536, 33231539, 33231545, 33231546, 33231554, 33231611, 33231614, 33231618, 33231623, 33231625, 33231628, 33231635, 33231636, 33231639, 33231641, 33231685, 33231712, 33231728, 33231733, 33231737, 33231741, 33231745, 33231755, 33231758, 33232813, 33232814, 33232816, 33237363, 33238809, 33239104, 33239111, 33239118, 33239125, 33239127, 33239134, 33239139, 33239154, 33239159, 33239164, 33239184, 33239194, 33239206, 33239243, 33239251, 33239260, 33239261, 33239262, 33239264, 33239265, 33239267, 33240071, 33240074, 33240087, 33240093, 33240102, 33240104, 33240106, 33240109, 33243833, 33243849, 33243931, 33243932, 33246462, 33246464, 33246487, 33246497, 33246540, 33246541, 33246542, 33246543, 33246547, 33246549, 33246553, 33246555, 33247992, 33248321, 33248795, 33249349, 33250900, 33250959, 33251067, 33251163, 33251910, 33251916, 33251930, 33251931, 33252751, 33252759, 33252761, 33253017, 33253280, 33253300, 33253307, 33253309, 33253312, 33253326, 33253657, 33253672, 33253674, 33253677, 33253685, 33253686, 33253688, 33253690, 33253692, 33253696, 33253702, 33253802, 33253856, 33256721, 33256754, 33257098, 33257992, 33257995, 33258002, 33258014, 33258020, 33258025, 33258144, 33258680, 33258681, 33258882, 33258928, 33258977, 33260378, 33263266, 33263968, 33263978, 33263979, 33263980, 33263981, 33263982, 33263983, 33263984, 33263985, 33264009, 33264938, 33264939, 33264985, 33265077, 33265234, 33265894, 33266080, 33266081, 33266082, 33266370, 33266563, 33270939, 33273829, 33305421, 33306158, 33311964, 33312079, 33312128, 33315985, 33319396, 33321355, 33323852, 33323853, 33323880, 33323898, 33324363, 33324393, 33324403, 33324407, 33325469, 33325476, 33328495, 33328497, 33328499, 33328502, 33328503, 33328514, 33328518, 33333261, 33333298, 33335363, 33335435, 33335"," 33932353, 33932365, 33932367, 33932370, 33932371, 33932377, 33932379, 33932381, 33932405, 33932407, 33932409, 33932411, 33932416, 33932417, 33932449, 33932453, 33932455, 33932459, 33932460, 33932461, 33932462, 33932463, 33932464, 33932465, 33932467, 33932468, 33932754, 33932756, 33932757, 33932761, 33932763, 33932765, 33932768, 33932771, 33932772, 33932775, 33932777, 33932781, 33932782, 33932783, 33932819, 33932821, 33932981, 33932999, 33933008, 33933023, 33933730, 33934514, 33934516, 33934670, 33934709, 33934710, 33934711, 33934713, 33934715, 33934716, 33934717, 33934718, 33934719, 33934720, 33934721, 33934722, 33934724, 33934727, 33934734, 33934775, 33934788, 33934789, 33934807, 33934808, 33934809, 33934811, 33934812, 33934813, 33934814, 33934819, 33934824, 33934833, 33934835, 33935829, 33935832, 33935884, 33935885, 33935886, 33935887, 33935930, 33935973, 33936025, 33936028, 33936029, 33936031, 33936051, 33936097, 33936107, 33936141, 33936142, 33936150, 33936151, 33936153, 33936156, 33936158, 33936160, 33936162, 33936167, 33936171, 33950383, 33950391, 33950395, 33950397, 33950400, 33950401, 33950403, 33950404, 33950879, 33950884, 33951233, 33951238, 33951244, 33951250, 33951251, 33951252, 33951253, 33951254, 33951255, 33951256, 33951257, 33951258, 33951264, 33951352, 33951394, 33951399, 33951400, 33951446, 33951455, 33951463, 33951485, 33951486, 33951488, 33951490, 33951492, 33951493, 33951514, 33951521, 33951527, 33951640, 33951643, 33951647, 33951648, 33951650, 33951689, 33951691, 33951693, 33951695, 33951698, 33951744, 33951771, 33951772, 33951773, 33951774, 33951776, 33951777, 33951778, 33951780, 33951781, 33951782, 33951817, 33951819, 33951820, 33951821, 33951822, 33951823, 33951824, 33951825, 33951827, 33951828, 33951829, 33951830, 33951831, 33951832, 33951835, 33951836, 33951840, 33951841, 33951842, 33951843, 33951845, 33951846, 33951847, 33951848, 33951849, 33951850, 33951851, 33951852, 33951853, 33951854, 33951855, 33951856, 33951857, 33951858, 33951860, 33951861, 33951862, 33951863, 33951864, 3395","54,197 units in US and 78,627 units internationally (total 132, 824 units)","LIFEPAK CR Plus or LIFEPAK Express Automated External Defibrillators (AEDs) are recalled due to the potential to experience an early internal battery depletion issue.",2/8/2013,"02/08/2013",4/17/2013,"04/17/2013"
"Food",64428,"Ongoing","Conagra Inc","Omaha","NE","US","Voluntary: Firm Initiated","Telephone","Distribution was made to AR, AL, AZ, CA, FL, GA, IL, IN, KY, LA, MS, ME, NV, NY, MO, OH, OK, PA, TX, UT, VA, WA, WI, WY and Canada.","F-1245-2013","Class II","Great Value All Natural Mild Chunky Salsa, 24 oz (1-lb 8-oz) 680 g.; UPC 007874208639; Distributed by: Wal-Mart Stores, Inc, Bentonville, AR","Code Date: 012314",".","3,239/12/24-oz jar/cases","The products may contain plastic pieces.",2/17/2013,"02/17/2013",3/27/2013,"03/27/2013"
"Food",64428,"Ongoing","Conagra Inc","Omaha","NE","US","Voluntary: Firm Initiated","Telephone","Distribution was made to AR, AL, AZ, CA, FL, GA, IL, IN, KY, LA, MS, ME, NV, NY, MO, OH, OK, PA, TX, UT, VA, WA, WI, WY and Canada.","F-1247-2013","Class II","Great Value All Natural Medium Chunky Salsa, 24 oz (1lb 8oz) 680 g.; UPC 007874208640; Distributed by: Wal-Mart Stores, Inc, Bentonville, AR","Code Date: 013014 and 020614",".","15,075/12/24-oz/cases","The products may contain plastic pieces.",2/17/2013,"02/17/2013",3/27/2013,"03/27/2013"
"Food",64428,"Ongoing","Conagra Inc","Omaha","NE","US","Voluntary: Firm Initiated","Telephone","Distribution was made to AR, AL, AZ, CA, FL, GA, IL, IN, KY, LA, MS, ME, NV, NY, MO, OH, OK, PA, TX, UT, VA, WA, WI, WY and Canada.","F-1246-2013","Class II","Great Value Salsa Mild, 16 oz (1lb) 454 g.; UPC 007874212780; Distributed by: Wal-Mart Stores, Inc, Bentonville, AR","Code Date:013013 and 020414",".","5,582/12/16-oz jar/cases","The products may contain plastic pieces.",2/17/2013,"02/17/2013",3/27/2013,"03/27/2013"
"Food",64428,"Ongoing","Conagra Inc","Omaha","NE","US","Voluntary: Firm Initiated","Telephone","Distribution was made to AR, AL, AZ, CA, FL, GA, IL, IN, KY, LA, MS, ME, NV, NY, MO, OH, OK, PA, TX, UT, VA, WA, WI, WY and Canada.","F-1248-2013","Class II","Great Value All Natural Hot Chunky Salsa, 24 oz (1lb 8oz) 680 g.; UPC 0078745208641; Distributed by: Wal-Mart Stores, Inc, Bentonville, AR","Code Date: 020514 and 020614",".","12,317/12/24-oz/jar/cases","The products may contain plastic pieces.",2/17/2013,"02/17/2013",3/27/2013,"03/27/2013"
"Biologics",64429,"Terminated","Community Blood Centers of South Florida, Inc.","Hialeah","FL","US","Voluntary: Firm Initiated","Letter","Switzerland; Florida; New York","B-1413-13","Class II","Red Blood Cells","2615454; 2536100; 2351667; 1791712; 1692582; 1699599; 9671521; 9458747; ",".","8","Blood products, collected from a donor whose suitability to donate was not adequately determined, were distributed.",1/30/2013,"01/30/2013",6/12/2013,"06/12/2013"
"Biologics",64429,"Terminated","Community Blood Centers of South Florida, Inc.","Hialeah","FL","US","Voluntary: Firm Initiated","Letter","Switzerland; Florida; New York","B-1414-13","Class III","Blood and Blood Products for Reprocessing","2351667; 9671521; 9638986; 9458747; ",".","4","Blood products, collected from a donor whose suitability to donate was not adequately determined, were distributed.",1/30/2013,"01/30/2013",6/12/2013,"06/12/2013"
"Biologics",64429,"Terminated","Community Blood Centers of South Florida, Inc.","Hialeah","FL","US","Voluntary: Firm Initiated","Letter","Switzerland; Florida; New York","B-1410-13","Class II","Fresh Frozen Plasma","2615454; 2536100; 1791712; 1692582; 1699599; ",".","5","Blood products, collected from a donor whose suitability to donate was not adequately determined, were distributed.",1/30/2013,"01/30/2013",6/12/2013,"06/12/2013"
"Biologics",64429,"Terminated","Community Blood Centers of South Florida, Inc.","Hialeah","FL","US","Voluntary: Firm Initiated","Letter","Switzerland; Florida; New York","B-1412-13","Class II","Platelets","1791712; 9671521; 9638986; ",".","3","Blood products, collected from a donor whose suitability to donate was not adequately determined, were distributed.",1/30/2013,"01/30/2013",6/12/2013,"06/12/2013"
"Biologics",64429,"Terminated","Community Blood Centers of South Florida, Inc.","Hialeah","FL","US","Voluntary: Firm Initiated","Letter","Switzerland; Florida; New York","B-1409-13","Class II","Platelets Pooled Leukocytes Reduced","2935922; 2917309; 2906733; ",".","3","Blood products, collected from a donor whose suitability to donate was not adequately determined, were distributed.",1/30/2013,"01/30/2013",6/12/2013,"06/12/2013"
"Biologics",64429,"Terminated","Community Blood Centers of South Florida, Inc.","Hialeah","FL","US","Voluntary: Firm Initiated","Letter","Switzerland; Florida; New York","B-1411-13","Class II","Red Blood Cells (Apheresis) Leukocytes Reduced","W036810024856; W036810024856; W036808146279; W036808146279; 2084027; 2084027; 9638986; ",".","7","Blood products, collected from a donor whose suitability to donate was not adequately determined, were distributed.",1/30/2013,"01/30/2013",6/12/2013,"06/12/2013"
"Biologics",64430,"Terminated","Community Blood Bank of Erie County","Erie","PA","US","Voluntary: Firm Initiated","Telephone","Pennsylvania; New York","B-1384-13","Class III","Red Blood Cells","W045613818099; W045613818100; W045613818110; ",".","3","Blood products, collected from donors whose hematocrits were determined using an analyzer with an invalid QC control, were distributed. ",2/7/2013,"02/07/2013",6/12/2013,"06/12/2013"
"Biologics",64431,"Terminated","University Of Miami Miller School of Medicine Tissue Bank","Miami","FL","US","Voluntary: Firm Initiated","Telephone","Florida","B-1466-13","Class II","Bone","0092190096",,"1 allograft","Human tissue allograft was processed in a manner that could cause contamination or cross-contamination during processing, and well as the introduction, transmission, or spread of communicable disease through the use of the HCT/P. ",2/19/2013,"02/19/2013",5/22/2013,"05/22/2013"
"Biologics",64432,"Terminated","Community Blood Centers of South FL, Inc.","Orlando","FL","US","Voluntary: Firm Initiated","Letter","Florida","B-1104-13","Class II","Red Blood Cells","W036810231777; ",".","1","Blood product, collected from a donor whose suitability to donate was not adequately determined, was distributed.",1/29/2013,"01/29/2013",6/12/2013,"06/12/2013"
"Veterinary",64433,"Ongoing","Honest Kitchen","San Diego","CA","US","Voluntary: Firm Initiated","Press Release","Nationwide in the US and in Canada.","V-227-2013","Class I","Verve, 4lb box, 6 units/case, Item# V4, UPC 183413000 89 5, and 10 lb box, 4 units/case, Item #VR, UPC 183413000 17 8.","Item Code: V4 + VR, Lot # 2332A (batches 1-3). Item Code: VR, Lot # 3062A (batches 8 & 9).",,"2,960 units","The Honest Kitchen is recalling five lots of its Verve, Zeal and Thrive pet food products because they have the potential to be contaminated with Salmonella. ",2/21/2013,"02/21/2013",7/31/2013,"07/31/2013"
"Veterinary",64433,"Ongoing","Honest Kitchen","San Diego","CA","US","Voluntary: Firm Initiated","Press Release","Nationwide in the US and in Canada.","V-229-2013","Class I","Zeal, 4lb box, 6 units/case, Item#Z4, UPC 18341300195 3, and 10lb box, 4 units/case, Item# ZR, UPC 18341300191 5.","Item Code: Z4 + ZR, Lot # 2272A (batches 1-5). Item Code: ZR, Lot # 2652A (batches 1-4).",,"4,986 units","The Honest Kitchen is recalling five lots of its Verve, Zeal and Thrive pet food products because they have the potential to be contaminated with Salmonella. ",2/21/2013,"02/21/2013",7/31/2013,"07/31/2013"
"Veterinary",64433,"Ongoing","Honest Kitchen","San Diego","CA","US","Voluntary: Firm Initiated","Press Release","Nationwide in the US and in Canada.","V-228-2013","Class I","Free Thrive, 1 oz. sample, 50 units/case, Item#TMC, UPC 183413000 81 9.","Lot # 2622A (batch 3)",,"15,650 units","The Honest Kitchen is recalling five lots of its Verve, Zeal and Thrive pet food products because they have the potential to be contaminated with Salmonella. ",2/21/2013,"02/21/2013",7/31/2013,"07/31/2013"
"Devices",64434,"Ongoing","Myco Medical Supplies Inc","Cary","NC","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Worldwide Distribution - USA including CA, FL, IL, MI, MO, NY, OH, PA, SC, TN, WI and Internationally to Canada","Z-0891-2013","Class II","Technocut Plus,Sterile Single Use Safety Scalpel, Distributed by: Myco Medial Cary, NC 27513. The Technocut Plus Safety Scalpel is a surgical safety scalpel intended for use as a cutting device during surgical, pathology, and minor medical procedures.","Catalogue number: 6008TR-10, 6008TR-11, 6008TR-12, 6008TR-15, 6008TR-20; Batch numbers: 1208235, 1210189, 1211305, 1208276, 1211213, 1208224, 1210105, 1212041, 1208307, 1211192, 1212052, 1210116.",,"110,768 scalpels in individual pouches","Pouch labeling/printing errors and defective packaging resulting in possible compromised sterility.",2/7/2013,"02/07/2013",3/6/2013,"03/06/2013"
"Devices",64435,"Ongoing","Intio Inc","Broomfield","CO","US","Voluntary: Firm Initiated","Letter","Nationwide Distribution including MN, FL, PA, WI, NY, and RI.","Z-0974-2013","Class II","INTIO Inc., ClearStart-SVM Segmentation and Volumetric Measurement System, Users Manual. Part #: UM-06-20-0003. ClearStart-SVM is used for patient assessment using CT (computed tomography) images, in order to plan potential therapies or monitor tumor response to treatment.","INTIO Inc. Part #: UM-06-20-0003 for SVM User's Manual ",".","7","INTIO Inc. distributed a SVM User's Manual and it has an editing mistake that could be interpreted as promoting an unapproved use. ",2/26/2013,"02/26/2013",3/27/2013,"03/27/2013"
"Devices",64436,"Ongoing","Philips Medical Systems (Cleveland) Inc","Cleveland","OH","US",,"Letter","Worldwide Distribution - USA including AR, AZ, IN, KS, LA, MA, MN, MS, MT, NJ, NY, NY, OH, OR, PA, TN, TX, VT, WV, WY, and worldwide including the contries of Australia, Belgium, China, France, Germany, Israel, Japan, Norway, Sweeden, and Switzerland.","Z-0950-2013","Class II","Brilliance 64 and Ingenuity Computed Tomography X-Ray Systems The Brilliance 64 and Ingenuity CT are whole body Computed Tomography X-Ray Systems intended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission data taken at different angles and planes. This device may include signal analysis and display equipment, patient, and equipment supports, components and accessories.","Brilliance 64: 728231 & Ingenuity CT: 728326, 728323. System Code # 728231, Serial #: 9654, 91003, 95130, 95157, 95504 System Code # 728326, Serial #: 32000,300003,300004,300005,300010,300011,300012,300014,300015,300018,300027,300041,300053,300059,300066,300070,300071,300073,300074,300078,300079,300080,300082,300084,300086,300091,300095,300101,300102,300112,300127,300128,300129,300131,300132,310064 System Code # 728323, Serial #: 320033",,"42 Units","This field change order is being released to update software and customer release notes to the affected installed base.",2/15/2013,"02/15/2013",3/20/2013,"03/20/2013"
"Food",64438,"Ongoing","The King Arthur Flour Company, Inc.","Norwich","VT","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Nationwide","F-1195-2013","Class II","King Arthur Unbleached All-Purpose Flour, 5-lb. bagUPC 0-71012-01050-9","Best Used By/ Lot Code12/26/2013 L12A26B; 12/26/2013 L12A26C; 12/27/2013 L12A27A; 01/18/2014 A13A18A; 01/18/2014 A13A18B; 01/21/2014 A13A21A; 01/22/2014 A13A22B; 01/30/2014 A13A30A; 01/31/2014 A13A31A.",,"40,240/5 Lb","Foreign material",2/22/2013,"02/22/2013",3/20/2013,"03/20/2013"
"Food",64438,"Ongoing","The King Arthur Flour Company, Inc.","Norwich","VT","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Nationwide","F-1196-2013","Class II","King Arthur Unbleached Bread Flour, 5-lb. bagUPC 0-71012-04105-3","Best Used By/ ot Code12/26/2013 L12A26A; 12/26/2013 L12A26B; 01/03/2014 A13A03A; 01/03/2014 A13A03B; 01/16/2014 A13A16B; 01/17/2014 A13A17A; 01/23/2014 A13A23A; 01/28/2014 A13A28A; 01/31/2014 A13A31A. ",,"63272/5 Lb","Foreign material",2/22/2013,"02/22/2013",3/20/2013,"03/20/2013"
"Devices",64439,"Ongoing","Medtronic Neuromodulation","Minneapolis","MN","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution - USA Nationwide and the countries of: Algeria, Australia, Austria, Belarus, Belgium, Brazil, Bulgaria, Canada, Chile, China, Colombia, Costa Rica, Croatia, Cyprus, Czech Republic, Denmark, Dominican Republic, Ecuador, Egypt, El Salvador, Estonia, Finland, France, Germany, Greece, Hong Kong, Hungary, Iceland, India, Ireland, Israel, Italy, Japan, Jordan, Korea, Latvia, Lebanon, Lithuania, Luxembourg, Malaysia, Malta, Mexico, Morocco, Netherlands, New Zealand, Norway, Peru, Philippines, Poland, Portugal, Puerto Rico, Romania, Russian Federation, Saudi Arabia, Singapore, Slovakia, Slovenia, South Africa, Spain, Sri Lanka, Sweden, Switzerland, Taiwan, Thailand, Tunisia, Turkey, Ukraine, United Arab Emirates, United Kingdom, Uruguay, Venezuela, Viet Nam.","Z-1190-2013","Class I","Medtronic DBS Lead Kit for Deep Brain Stimulation, models 3387, 3387S, 3389, 3389S, 3391, 3391S. Sterile and Non-Pyrogenic. Product Usage: The deep brain stimulation system delivers electrical stimulation to selected targets in the brain. DBS Leads are indicated for Dystonia, Essential Tremor (ET), Obsessive-Compulsive Disorder (OCD), Parkinsons Disease (PD), and epilepsy.","all product is affected as the lead kits are not being removed from the market. Medtronic is providing Additional Instructions for Capping the Lead and Removing the Lead Cap.",,"30,000","There is a potential for lead damage due to the use of the lead cap provided in DBS and Dystonia kits. Medtronic has received reports of DBS leads being damaged at the connector end of the lead when the lead cap is used. The connector end of the lead is the end of the lead connected to the lead extension. Tightening or loosening of the setscrew may twist the setscrew connector block and may damage the proximal connector end of the lead. If this happens, the damage would most likely occur at lead contact #3 which could affect electrode contact #3.",2/8/2013,"02/08/2013",5/8/2013,"05/08/2013"
"Devices",64439,"Ongoing","Medtronic Neuromodulation","Minneapolis","MN","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution - USA Nationwide and the countries of: Algeria, Australia, Austria, Belarus, Belgium, Brazil, Bulgaria, Canada, Chile, China, Colombia, Costa Rica, Croatia, Cyprus, Czech Republic, Denmark, Dominican Republic, Ecuador, Egypt, El Salvador, Estonia, Finland, France, Germany, Greece, Hong Kong, Hungary, Iceland, India, Ireland, Israel, Italy, Japan, Jordan, Korea, Latvia, Lebanon, Lithuania, Luxembourg, Malaysia, Malta, Mexico, Morocco, Netherlands, New Zealand, Norway, Peru, Philippines, Poland, Portugal, Puerto Rico, Romania, Russian Federation, Saudi Arabia, Singapore, Slovakia, Slovenia, South Africa, Spain, Sri Lanka, Sweden, Switzerland, Taiwan, Thailand, Tunisia, Turkey, Ukraine, United Arab Emirates, United Kingdom, Uruguay, Venezuela, Viet Nam.","Z-1191-2013","Class I","Medtronic DBS Therapy for Dystonia Kit, models 3317, 3319, 3337 and 3339. Sterile and Non-Pyrogenic. Product Usage: Dystonia Therapy Kit is indicated for unilateral or bilateral stimulation of the internal globus pallidus (GPi) or the subthalamic nucleus (STN) to aid in the management of chronic, intractable (drug refractory) primary dystonia, including generalized and/or segmental dystonia, hemidystonia, and cervical dystonia (torticollis). ","all product is affected as the lead kits are not being removed from the market. Medtronic is providing Additional Instructions for Capping the Lead and Removing the Lead Cap.",,"30,000","There is a potential for lead damage due to the use of the lead cap provided in DBS and Dystonia kits. Medtronic has received reports of DBS leads being damaged at the connector end of the lead when the lead cap is used. The connector end of the lead is the end of the lead connected to the lead extension. Tightening or loosening of the setscrew may twist the setscrew connector block and may damage the proximal connector end of the lead. If this happens, the damage would most likely occur at lead contact #3 which could affect electrode contact #3.",2/8/2013,"02/08/2013",5/8/2013,"05/08/2013"
"Devices",64440,"Ongoing","Steris Corporation","Mentor","OH","US",,"Visit","Worldwide Distribution - USA including Canada and the states of AK, AL, AR, AZ, CA, CO, CT, DC, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, MI, MN, MO, MS, NC, ND, NE, NH, NJ, NM, NY, OH, OK, OR, PA, SC, SD, SK, TN, TX, UT, VA, VT, WA, WI, and WV.","Z-0915-2013","Class II","AMSCO C and AMSCO 400 Steam Sterilizers designed for sterilization of heat and moisture-stable materials used in healthcare facilities.","AMSCO C: Serial Numbers: 021911201 023461202AMSCO 400: Serial Numbers: 030181215-030291310 ",,"395 Units","The control boards alarm set points and temperature tolerances allowed for erroneous activation of the AD (analog/digital) alarm as temperature fluctuated during operation. When this alarm occurs, the sterilizer locks up and cannot be used until serviced, causing Customer nuisance.",2/12/2013,"02/12/2013",3/13/2013,"03/13/2013"
"Drugs",64441,"Ongoing","Hospira Inc.","Lake Forest","IL","US","Voluntary: Firm Initiated","Letter","Nationwide","D-176-2013","Class II","0.9% Sodium Chloride Irrigation, USP, 3000 mL, Sterile, Non pyrogenic, Rx Only, Hospira, Inc., Lake Forest, IL 60045, NDC 0409-7972-08","Lot 13-121-JT* * the lot number may be followed by 01",,"56,854 Units","Lack of Assurance of Sterility: There is a potential for the solution to leak from the administration port of the primary container.",2/12/2013,"02/12/2013",3/6/2013,"03/06/2013"
"Food",64442,"Ongoing","Bruce Foods Corp","New Iberia","LA","US","Voluntary: Firm Initiated","Press Release","VA, MN, IN","F-1055-2013","Class I","Food Club(R) MEXICAN STYLE ENCHILADA SAUCE, RED, NET WT 10 OZ (284g), DISTRIBUTED BY TOPCO ASSOCIATES LLC, 7711 GROSS POINT RD., SKOKIE, IL 60077UPC: 036800292208 ","GES 462449, Best Before Date: 12/03/2016",,"141 cases of 12 units","Undeclared soy and wheat: One can of product labeled as containing red enchilada sauce, was found to contain green enchilada sauce which contains wheat and soy. ",2/21/2013,"02/21/2013",3/13/2013,"03/13/2013"
"Food",64443,"Ongoing","Wholesale Baking, Inc.","Salem","OR","US","Voluntary: Firm Initiated","Telephone","distributed directly to one sole consignee in Oregon","F-1250-2013","Class II","Ruthies Cashew Raisin Breakfast Cookie, individually wrapped in plastic, net wt. 4.9 oz. The product is labeled in parts: ''***Ruthies Cashew Raisin Breakfast COOKIE***INGREDIENTS***Butter***Half & Half***NET WT. 4.9 Oz***Manufactured for Ruthie's, LLC***www.ruthiescookies.com***(888) 7-RUTHIE***''.","no codes",,"123 cases/ 24 pieces per case","Ruthies Cashew Raisin Breakfast Cookie is recalled because butter and half & half are declared but milk is NOT declared on label.",2/21/2013,"02/21/2013",4/3/2013,"04/03/2013"
"Food",64443,"Ongoing","Wholesale Baking, Inc.","Salem","OR","US","Voluntary: Firm Initiated","Telephone","distributed directly to one sole consignee in Oregon","F-1249-2013","Class II","Ruthies Cranberry Orange Breakfast Cookie, individually wrapped in plastic, net wt. 4.9 oz. The product is labeled in parts: ''***Ruthies Cranberry Orange Breakfast COOKIE***INGREDIENTS***Butter (pasteurized cream, salt)***Contains the following allergens: Wheat, Eggs***NET WT. 4.9 Oz***Manufactured for Ruthie's, LLC***www.ruthiescookies.com******(888) 7-RUTHIE***''.","no codes",,"30 cases/24 pieces per case","Ruthies Cranberry Orange Breakfast Cookie is recalled because butter (cream) is declared but milk is NOT declared on label.",2/21/2013,"02/21/2013",4/3/2013,"04/03/2013"
"Devices",64444,"Ongoing","Becton Dickinson & Co.","Sparks","MD","US","Voluntary: Firm Initiated","Letter","Distributed in the states of CA, FL, GA, NJ, and TX.","Z-1215-2013","Class II","BD ProbeTec Neisseria gonorrhoeae (GC) Qx Amplified DNA Assay Reagent Pack, REF 441124, contains 12 each Microwells labeled in part ***BD ProbeTec Neisseria gonorrhoeae (GC) Qx Amplified DNA Assay Reagent Pack REF 441124 ***For use with the BD Viper System *** Becton, Dickinson and Company 7 Loveton Circle, Sparks, MD 21152 USA www.bd.com/ds EC REP Benex Limited, Pottery Road, Dun Laoghaire, Co. Dublin, Ireland. Assay is indicated for use with asymptomatic and symptomatic individuals to aid in the diagnosis of gonococcal urogenital disease. ","Lot No./Exp. Date: 2237214 / 2013-10-31.",".","77 kits","Increased levels of false positives in BD Probe Tech Neisseria gonorrhoeae Q Amplified DNA assay kits.",2/8/2013,"02/08/2013",5/15/2013,"05/15/2013"
"Veterinary",64445,"Ongoing","Hy-Vee Stores Inc","West Des Moines","IA","US","Voluntary: Firm Initiated","Press Release","Distribution was made to 212 retail stores in IA, IL, MO, KS, NE, SD, MN and WI.","V-140-2013","Class II","Hy-Vee Complete Dog, Complete Nutrition, 34-lb bag. UPC code: 07545005647","Lot # ending with 29812KC, Best by date: 11/24/13",,"879/34-lb bags","The recalled products may contain elevated levels of Aflatoxin.",2/22/2013,"02/22/2013",4/3/2013,"04/03/2013"
"Veterinary",64445,"Ongoing","Hy-Vee Stores Inc","West Des Moines","IA","US","Voluntary: Firm Initiated","Press Release","Distribution was made to 212 retail stores in IA, IL, MO, KS, NE, SD, MN and WI.","V-141-2013","Class II","Hy-Vee Complete Dog, Complete Nutrition, 8-lb bag. UPC code: 07545005667","Lot # ending with 29812KC, Best by date: 11/24/13",,"2,500/8-lb bags","The recalled products may contain elevated levels of Aflatoxin.",2/22/2013,"02/22/2013",4/3/2013,"04/03/2013"
"Veterinary",64445,"Ongoing","Hy-Vee Stores Inc","West Des Moines","IA","US","Voluntary: Firm Initiated","Press Release","Distribution was made to 212 retail stores in IA, IL, MO, KS, NE, SD, MN and WI.","V-143-2013","Class II","Hy-Vee Complete Dog, Bones & Squares, 20-lb bag. UPC code: 07545005680","Lot # ending with 29312KC, Best by date: 11/19/13",,"800/20-lb bags","The recalled products may contain elevated levels of Aflatoxin.",2/22/2013,"02/22/2013",4/3/2013,"04/03/2013"
"Veterinary",64445,"Ongoing","Hy-Vee Stores Inc","West Des Moines","IA","US","Voluntary: Firm Initiated","Press Release","Distribution was made to 212 retail stores in IA, IL, MO, KS, NE, SD, MN and WI.","V-142-2013","Class II","Hy-Vee Complete Dog, Complete Nutrition, 4.4-lb bag. UPC code: 07545005665","Lot # ending with 29812KC, Best by date: 11/24/13 and Lot # ending with 29912KC, Best by date: 11/25/13",,"7,250/4.4-lb bags","The recalled products may contain elevated levels of Aflatoxin.",2/22/2013,"02/22/2013",4/3/2013,"04/03/2013"
"Veterinary",64445,"Ongoing","Hy-Vee Stores Inc","West Des Moines","IA","US","Voluntary: Firm Initiated","Press Release","Distribution was made to 212 retail stores in IA, IL, MO, KS, NE, SD, MN and WI.","V-144-2013","Class II","Hy-Vee Complete Dog, Bones & Squares, 4.4-lb bag. UPC code: 07545005660","Lot # ending with 29312KC, Best by date: 11/19/13",,"1,760/4.4-lb bags","The recalled products may contain elevated levels of Aflatoxin.",2/22/2013,"02/22/2013",4/3/2013,"04/03/2013"
"Food",64446,"Ongoing","L. K. Bowman, Incorporated","Nottingham","PA","US","Voluntary: Firm Initiated","letter","Product was distributed to one firm in Utah, USA.","F-1327-2013","Class II","Canned mushrooms, #10 cans (Brites, not labeled)","Lot 11 363 A 895BD",".","3,480","Some isolated spoilage was found in this lot of #10 cans.",1/31/2013,"01/31/2013",4/24/2013,"04/24/2013"
"Devices",64447,"Ongoing","Draeger Medical, Inc.","Telford","PA","US","Voluntary: Firm Initiated","Letter","Distributed in the states of CA, IL, and MA.","Z-0939-2013","Class II","Draeger Infinity Acute Care System (IACS) Monitoring Solution. Catalog Number MS20783 (Infinity MCable-Dual Hemo) Physiological patient monitoring system.","Catalog Number MS20783 (Infinity MCable-Dual Hemo)",,"260","The displayed value for the invasive blood pressure measurement of the IACS was different than the actual patient values. Liquid ingress in the cable connection may cause inaccurate measurements. This can happen if the Dual Hemo MCable is used in a non-vertical position, a vertical position but upside down, or laying it on the floor or on the patient bed. ",12/13/2012,"12/13/2012",3/20/2013,"03/20/2013"
"Devices",64448,"Ongoing","Zyno Medical LLC","Natick","MA","US","Voluntary: Firm Initiated","Letter","Nationwide Distribution.","Z-1024-2013","Class II","Z-800 Volumetric Infusion System. For intravenous infusion of parenteral fluids, blood and blood products to a human patient.","LOT #20080416-zs5, 20080711-zs5, 20080826-zs5, 20081022-zs5, 20090126-zs5 20090320-zs5, 20090507-zs5, 20090612-zs5, 20090706-zs5,20090910-zs5 20091110-zs5, 20100106-C, 20100420-D, 20100729, 20101005-BJ 20100910-SH, 20101013-SH, 20101206-SH, 20110110-SH, 20110111-SH 20110204-SH, 20110210-SH, 20110308-SH, 20110505-SH ",".","2589 units","Update Instruction For Use for Preventative Maintenance (PM) Schedule and addition of Odometer software to monitor accumulative fluid volume infused by the pump",6/13/2011,"06/13/2011",4/10/2013,"04/10/2013"
"Biologics",64450,"Terminated","Upstate New York Transplant Services","Buffalo","NY","US","Voluntary: Firm Initiated","Telephone","New York","B-1442-13","Class II","Cryoprecipitated AHF","W280312001390; ",".","1","Blood products, collected from a donor whose suitability to donate was not adequately determined, were distributed.",2/11/2013,"02/11/2013",6/12/2013,"06/12/2013"
"Biologics",64450,"Terminated","Upstate New York Transplant Services","Buffalo","NY","US","Voluntary: Firm Initiated","Telephone","New York","B-1441-13","Class II","Red Blood Cells Leukocytes Reduced","W280312001390; ",".","1","Blood products, collected from a donor whose suitability to donate was not adequately determined, were distributed.",2/11/2013,"02/11/2013",6/12/2013,"06/12/2013"
"Biologics",64451,"Terminated","LifeSouth Community Blood Centers, Inc.","Gainesville","FL","US","Voluntary: Firm Initiated","FAX","Florida","B-1017-13","Class II","Platelets Pheresis Leukocytes Reduced","W1151130020407; ",".","1","Blood product, labeled leukoreduced without the assurance that it met the criteria for a leukoreduced product, was distributed.",1/21/2013,"01/21/2013",6/12/2013,"06/12/2013"
"Devices",64452,"Ongoing","Ebi, Llc","Parsippany","NJ","US","Voluntary: Firm Initiated","Letter","Nationwide Distribution including the states of AL, IN, MO, NE TN and TX.","Z-0954-2013","Class II","Biomet Spine Polaris 5.5 Button Lock Screw Inserter. Catalog Number 14-500178. The Polaris Spinal System is a non-cervical, pedicle screw spinal fixation device.","Catalog Number 14-500178. Lot numbers: 543619, 543853, 543853-1, 543853-2, 544233, 544234-1, 546613 and 546613-1.",".","59 units.","Increased risk of failure at the driver tip during screw insertion or removal.",2/7/2013,"02/07/2013",3/27/2013,"03/27/2013"
"Devices",64453,"Ongoing","Roche Diagnostics Operations, Inc.","Indianapolis","IN","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Nationwide Distribution including Puerto Rico and the states of MO, NE, CO, MT, NJ, FL, WA, TX, GA, NY, KS, NH, VA, HI, PA, MI, IA, CA, NC, AZ, UT, LA, IL, TN, ME, MN, KY, CT, OR, NV, AL and NM.","Z-1028-2013","Class II","Roche Molecular Systems cobas x 480 System 50 mL reagent reservoir, Catalog number 05232732001. Used with the cobas CT/NG 4800 System, for in vitro diagnostics. ","Lot / SN : 477415,477416, 477898, and 477899",".","189 units","Certain lots of Reagent reservoirs, 50mL used on the cobas 4800 System, may not have a separation in the lower part of the reservoir. As a consequence, pipetting errors can occur due to uneven distribution of reagent. These pipetting errors may lead to delayed results and wasted reagent.",3/1/2013,"03/01/2013",4/10/2013,"04/10/2013"
"Devices",64454,"Ongoing","PhotoMedex, Inc.","Montgomeryville","PA","US","Voluntary: Firm Initiated","Telephone","Worldwide Distribution-USA including the states of AR, KS and OH, and the countries of Germany, South Africa and the United Kingdom.","Z-0005-2014","Class II","The product is labeled in part ''***Surgical Laser Technologies, Inc. Montgomeryville, PA***SLT Fiber Delivery System***Sterile***Non-Pyrogenic***. The product is packaged in a flexible pouch and includes the following laser surgery accessories - SLT-SSRH 8, Catalog/Product Number 0041-3082; SLT-SSRH 11, Catalog/Product Number 0041-3112; SLT-SSRH 4-SMA, Catalog/Product Number 0042-0075; SLT-SSRH 5-SMA, Catalog/Product Number 0042-0076; SLT-SSRH 6-SMA, Catalog/Product Number 0042-0077; SLT-SSRH 7-SMA, Catalog/Product Number 0042-0078; SLT-SSRH 8-SMA, Catalog/Product Number 0042-0079; SLT-SSRH 9-SMA, Catalog/Product Number 0041-4931; and SLT-SSRH 10-SMA, Catalog/Product Number 0042-0081. Indicated for the incision, excision, coagulations, and vaporization of soft tissue. ","Lot number 226201",,"549","Firm became aware that some products within the specified lot may not have been sealed appropriately, thus compromising the sterile barrier.",1/4/2013,"01/04/2013",10/9/2013,"10/09/2013"
"Drugs",64455,"Ongoing","Hill Dermaceuticals, Inc.","Sanford","FL","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Nationwide","D-218-2013","Class III","Derma-Smoothe/FS (fluocinolone acetonide) 0.01% Topical Oil(SCALP OIL), Rx only, FOR TOPICAL USE ONLY, NOT FOR ORAL, OPHTHALMIC, OR INTRAVAGINAL USE, Net Contents 118.28 mL (4 fl. oz.), Hill Dermaceuticals, Inc., Sanford, Florida --- NDC 28105-149-04","Lot # D110550, Exp. 04/2013.",,"8,592 bottles","Subpotent; 22 month stability timepoint",11/21/2012,"11/21/2012",4/3/2013,"04/03/2013"
"Drugs",64455,"Ongoing","Hill Dermaceuticals, Inc.","Sanford","FL","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Nationwide","D-217-2013","Class III","Derma-Smoothe/FS (fluocinolone acetonide), 0.01% Topical Oil (Body Oil), Rx only, Hill Dermaceuticals, Inc., Sanford, Florida 32773 --- NDC 28105-150-04","Lot J111040, Exp. (09/13)",,"8,736 bottles","Subpotent; 12 month stability timepoint",11/21/2012,"11/21/2012",4/3/2013,"04/03/2013"
"Devices",64456,"Ongoing","Stryker Howmedica Osteonics Corp.","Mahwah","NJ","US","Voluntary: Firm Initiated","Letter","1 Branch (NJ) with one consignee (DE).","Z-0964-2013","Class II","Howmedica Osteonics Corp. Stryker Orthopaedics Specialty Triathlon Left and Right A//P Sizer Adjustment Housing PER File K2401. For use in knee prosthesis implantation. NON-STERILE","Catalog Number: I-K2401KF00 (note each is uniquely identified/marked as IK2401KF0L and IK2401KF0R - Left and Right). Lot Codes: AP5W52 and AP7H19.",".","4 units (total of 2 sets)","The standard Triathlon Femoral Stylus does not fit into the Specialty Sizers and that the ''R'' and ''L'' markings on the Right Sizer are reversed. ",1/24/2013,"01/24/2013",3/27/2013,"03/27/2013"
"Devices",64458,"Ongoing","Vygon Corporation","Montgomeryville","PA","US","Voluntary: Firm Initiated","Letter","Product was distributed to 4 hospitals (under one hospital network) within the State of Pennsylvania","Z-0937-2013","Class II","Churchill Medical Systems, Inc. A Vygon Company - All sizes of CMS-CT6T225 6F Triple Lumen CT PICC with M.S.T. Components, Peripherally Inserted Central Catheter.","Lots numbers MBKQ640, exp 05/2015; MBKZ720, exp 05/2015; MBLJ290, exp 06/2015; MBLR100, exp 07/2015; MBLZ350, exp 09/2015; and MBMG250, exp 10/2015.",,"210","Product was packaged with the incorrect introducer needle. The kit label indicates a ''safety'' needle is included; the kits were packaged with a non-safety needle.",12/17/2012,"12/17/2012",3/20/2013,"03/20/2013"
"Drugs",64459,"Ongoing","Warner Chilcott Company LLC","Fajardo","PR","US","Voluntary: Firm Initiated","Letter","US Nationwide and Puerto Rico","D-304-2013","Class III","Jevantique (norethindrone acetate and ethinyl estradiol) tablets; 1.0 mg/5.0 mcg, 90 count bottle (NDC# 52544-237-19), Rx only, Manufactured by Warner Chilcott Company, LLC, Fajardo, PR 00738, Distributed by Watson Pharma, Inc. Corona, CA 92880.","Lot # 507694A; exp 02/13 Lot # 510041C; exp 05/13",,"17,136 bottles","Chemical contamination: Firm's inspection discovered the presence of 2-phenylphenol in the product due to migration from the cardboard cartons in which the product is packaged.",2/15/2013,"02/15/2013",5/8/2013,"05/08/2013"
"Drugs",64459,"Ongoing","Warner Chilcott Company LLC","Fajardo","PR","US","Voluntary: Firm Initiated","Letter","US Nationwide and Puerto Rico","D-305-2013","Class III","Femhrt (norethindrone acetate and ethinyl estradiol) tablets, 1.0 mg/5.0 mcg, 90 count bottle ( NDC#: 0430-0544-23), Rx only, Manufactured by Warner Chilcott Company, LLC, Fajardo, PR 00738, Marketed by Warner Cholcott (US), LLC, Rockaway, NJ 07866 ","Lot# 507694B; exp 02/13",,"6,408 bottles","Chemical contamination: Firm's inspection discovered the presence of 2-phenylphenol in the product due to migration from the cardboard cartons in which the product is packaged.",2/15/2013,"02/15/2013",5/8/2013,"05/08/2013"
"Drugs",64459,"Ongoing","Warner Chilcott Company LLC","Fajardo","PR","US","Voluntary: Firm Initiated","Letter","US Nationwide and Puerto Rico","D-303-2013","Class III","Femhrt (norethindrone acetate and ethinyl estradiol) tablets, 0.5 mg/2.5 mcg, 90 count bottle (NDC#: 0430-0145-23), Rx only, Manufactured by Warner Chilcott Company, LLC, Fajardo, PR 00738, Marketed by Warner Cholcott (US), LLC, Rockaway, NJ 07866 "," Lot# 510122B; exp 04/13 ",,"27,509 bottles","Chemical contamination: Firm's inspection discovered the presence of 2-phenylphenol in the product due to migration from the cardboard cartons in which the product is packaged.",2/15/2013,"02/15/2013",5/8/2013,"05/08/2013"
"Devices",64460,"Ongoing","Roche Diagnostics Operations, Inc.","Indianapolis","IN","US","Voluntary: Firm Initiated","Letter","Nationwide Distribution.","Z-1114-2013","Class II","CoaguChek XS Pro meters (catalog number 05530199160)bar code scanner. Used with the CoagCHEK XS Pro Meters to quantitatively determines prothrombin time (''PT''). ","catalog number 05530199160 ",".","4467 both devices","Roche investigation into complaints found Accu-Chek Inform II and CoaguChek XS Pro System barcode reading meters had the potential of intermittent erroneous decoding of patient identification if barcodes being read fail to meet size and/or quality standards. Errors have been confirmed with the EAN 13 barcodes which should not be used for patient or operator identification.",3/6/2013,"03/06/2013",4/24/2013,"04/24/2013"
"Devices",64460,"Ongoing","Roche Diagnostics Operations, Inc.","Indianapolis","IN","US","Voluntary: Firm Initiated","Letter","Nationwide Distribution.","Z-1113-2013","Class II","ACCU-CHEK Inform II Blood Glucose Monitoring System bar code scanner. Used with the ACCU-CHEK Inform II System to quantitatively measure glucose (sugar).","part number 05060311001, 05060303001 ",".","Both devices 4467","Roche investigation into complaints found Accu-Chek Inform II and CoaguChek XS Pro System barcode reading meters had the potential of intermittent erroneous decoding of patient identification if barcodes being read fail to meet size and/or quality standards. ",3/6/2013,"03/06/2013",4/24/2013,"04/24/2013"
"Devices",64461,"Ongoing","Vital Images, Inc.","Minnetonka","MN","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution - All states in continental USA including DC, PR and the countries of ALGERIA, ARGENTINA, ANGOLA, ARMENIA, AUSTRALIA, AUSTRIA, BENGLADESH, BELARUS, BELGIUM, BOLIVIA, BOTSWANA, BRAZIL BULAGARIA, CAMBODIA, CANADA, CENTRAL AFRICAN REPUBLIC, CHAD, CHILE, CHINA , COLOMBIA, CONGO, CROATIA, CYRPRUS, CZECH REPUBLIC, DENMARK, DJIBOUTI, DOMINICAN REPUBLIC, ECUADOR, EGYPT, ESTONIA, ETHIOPIA, FINLAND, FRANCE, GREAT BRITAIN, GEORGIA, GERMANY, GHANA, GREECE, GUAM, HONDURAS, HONG KONG, HUNGARY, ICELAND, INDIA, INDONESIA, IRAQ, IRELAND, ISRAEL, ITALY, IVORY COAST, JAPAN, JORDAN, KAZAKHASTAN, KOREA, LEBANON, LITHUANIA, MACEDONIA, MALYASIA, MALI, MAURITIUS, MEXICO, MALDOVA, MOSCOW, NYNMAR, NAMBIA, NAMIRGIA, NEPAL, NETHERLANDS, NEW ZEALAND, NIGER, NIGERIA, NORTHERN IRELAND, NORWAY, OMAN, PAKISTAN, PANAMA, PARAGUAY, PERU, PHILLIPPINES, POLAND, PORTUGAL, QATAR, ROMANIA, RUSSIA, RUSSIAN FEDERATION, SAUDI ARABIA, SENEGAL, SERBIA, SEBIA AND MONROBIA, SINGAPORE, SLOVAKIA, SLOVENIA, SOMALIA, SOUTH AFRICA, SPAIN, SRI LANKA, SUDAN, SWEDEN, SWITZERLAND, TAIWAN, THAILAND, THE NETHERLANDS, TIBET, TUNISIA, TURKEY, UKRAINE, UNITED ARAB EMIRATES, UNITED KINGDOM, UZBERKISTAN, VENEZUELA, VIETNAM and YEMEN.","Z-1002-2013","Class II","Vitrea Enterprise Suite, Vitrea, VitreaAdvanced, VitreaCore (VitalConnect) and Vitrea fX prior to version 6.3.3, except 6.1.6, 6.2.3 and 6.3 The software is a medical diagnostic system that allows the processing, review, analysis, communication, and media interchange of multidimensional digital images acquired from a variety of imaging devices. It provides the ability to review digital images from original DICOM data for multiple modalities, including CT, MR, D, CR, XA, US, NM, PET, etc. The software is not meant for primary image interpretation in mammography. ","Serial Number 5080109343 5080109769 5080109726 5080123222 5080108401 5080107812 5080107804 5080107790 5080108428 5070933221 5070933248 5070933264 5070933272 5070933256 5080123109 5050411467 5080103442 5080103418 5090110913 5070934023 5080103434 5070931695 5080110775 5080113081 5080102977 5080103272 5080113340 5080121009 5080121122 5080121092 5080121106 5080121114 5080120827 5080111631 5080111755 5080116595 5080116609 5080116617 5080112883 5080122439 5080117214 5080119764 5080119772 5080119780 5080123095 5080121769 5080121750 5090102805 5070222244 5060213870 5070931709 5070216643 5090113203 5090103763 5090103771 5090104697 5090104700 5090104719 5090105030 5090105049 5090105057 5090106045 5090106053 5090106568 5090106584 5090106592 5090106606 5090110344 5090110352 5090112800 5060217876 5060217884 5070220144 5070218417 5070931687 5090113181 5090113173 5080103426 5060214044 5080119276 5080119284 5080110783 5080117206 5080119144 5080115483 5080121017 5080117532 5070219472 5080118911 5080108320 5090113548 5080107375 5020918865 5020919055 5080107405 5090113092 5080121963 540349 5050911664 5050911672 5070120134 5070120117 5050410843 5080119454 5080107367 5060218317 5050415063 5050910463 5080122404 5030334610 5080107499 3090900764 5090106460 5090106479 5090109648 457925 5030132252 5080121084 5060219208 5060218228 5060214206 5080116196 5070219405 5080121165 5030859349 5080115572 5080112905 5090111189 CRB1206112 5040916809 5090104298 5020915556 5090111804 5090111847 CRB1209129 5080114444 5080110198 5080108509 5080110465 5080105461 5080105860 5080119039 5080107391 5080108002 5080117559 5080109246 5080107502 5080107383 5080107464 5080107480 5080122781 5030549595 5080121041 540914 5070223372 5030857389 5060214184 5090113084 CRB1212157 5080109610 5080114568 5080112840 5080102519 5080121971 540444 VESADLCC1109026 5080109181 5080110309 5080115556 5080114681 5060219216 5090109567 5090111103 CRB1203086 CRB1206111 5080107758 5040224826 5060219240 5060215296 5060220273 5050410886 5021022792 5080112743 5080114657 5031216581 5030334"," 5050412765 5070223097 5050312000 5050412757 5070935070 5090105758 5090105766 5080120126 5060210561 5060210596 5080108592 5080108606 5080121262 5070223089 5090107351 CRB1201057 5080121521 5090108536 CRB1203069 5080107553 5080118237 5080102373 5080121491 5080121912 5080103469 5060211304 5080110341 5070931490 5080123281 5080120428 5080107197 5070930206 5050415020 5070930036 5050914140 5080116773 542175 5060217663 5070221515 5080109831 5060215342 5060215504 5080118512 5080118520 5080114940 5090105634 5060218589 5080109866 5060216551 5080117516 5060216543 5050410533 5090109400 5080109858 5050413923 5090111413 5090102384 5060218562 5060218570 5080114959 5060219992 5050910765 5090111014 5050912997 5060215490 5080109874 5050414717 5090102376 5050415179 5050415152 5080118970 5060219518 5060219976 5070120542 5060219984 5080112999 5080121890 5080113618 5070934244 5070934252 5070931717 5070934600 5070934619 5080115475 5070933752 5090112797 5080109122 UNK-29241 5060220540 5070932500 5070933825 5080110228 5090109370 5060219526 5090112290 5070221639 5080111968 5080115815 5070222716 5080107588 5021022598 5080102896 5080110716 5090104131 CRU1109020 5090104816 5070931377 5070931385 5080119497 5070216554 5070216562 5060215261 5070216805 5070216864 5070216694 5030862749 5040911270 5040912854 5040912870 5090104123 CRU1109019 5060211290 5060218732 5050411173 5070223321 5070931369 5060213439 5060220516 5060211851 5070933833 5070933841 5060217779 5030851984 5080110236 5070932217 5070932225 5090106681 5020510769 5050910900 5080109033 5080107723 5050143230 5050413583 5021020463 5030547479 5041215332 5041215359 5090106304 5060215822 5060215830 5080103809 5080116234 5041212635 5080110392 5050414210 5080119306 5070930214 5070930222 5070930230 5080104279 5080104287 5070931326 5080106328 5060220516 5070216759 5070222724 5070222732 5070219383 5070931415 5021021060 5080102543 5070931725 5030651500 5070931954 5070931962 5080121459 5070223364 5070220365 5080119055 5080104821 5070219383 5040913036 5080122110 5060215601 5080109947 5080108649 509","7649","Vital Images has found a potential error in measurement generated through the software which affects all versions of Vitrea Enterprise Suite, Vitrea, VitreaAdvanced, VitreaCore (VitalConnect) and Vitrea fX prior to version 6.3.3, except 6.1.6, 6.2.3 and 6.3. This error occurs when images are rotated at the time of reconstruction by the scanner in non-90 degree increments of the transverse/axial plane (rotation around the z-axis), while not being simultaneously rotated around the x-axis and y-axis. We have found this orientation adjustment to occur on rare occasions, such as to straighten tilts in head or neck scans, usually with minimal effect on measurements, but sometimes resulting in differences in length measurements of up to twenty-nine percent and in volume measurements of up to fifty percent, so please use caution when reviewing measurements of images reconstructed with orientations that are adjusted in such a manner. This issue was found through internal testing. No customer reports of the issue have been received. ",2/5/2013,"02/05/2013",4/3/2013,"04/03/2013"
"Biologics",64462,"Terminated","American Red Cross Blood Svs. Indiana-Ohio Region","Fort Wayne","IN","US","Voluntary: Firm Initiated","FAX","California; Indiana","B-1468-13","Class III","Blood and Blood Products for Reprocessing","038GZ69902; 038Y79139; ",".","2 units","Blood products, collected from a donor whose suitability to donate was not adequately determined, were distributed.",1/10/2013,"01/10/2013",6/12/2013,"06/12/2013"
"Biologics",64462,"Terminated","American Red Cross Blood Svs. Indiana-Ohio Region","Fort Wayne","IN","US","Voluntary: Firm Initiated","FAX","California; Indiana","B-1467-13","Class II","Red Blood Cells Leukocytes Reduced","038GZ69902; ",".","1","Blood products, collected from a donor whose suitability to donate was not adequately determined, were distributed.",1/10/2013,"01/10/2013",6/12/2013,"06/12/2013"
"Devices",64463,"Ongoing","Siemens Healthcare Diagnostics, Inc.","Newark","DE","US","Voluntary: Firm Initiated","Letter","Nationwide Distribution including the states of AK, AL, AR, AZ, CA, CO, DC, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, PR, SC, SD, TN, TX, UT, VA, VT, WA, WI, and WV.","Z-1049-2013","Class II","Siemens Dimension(R) Phosphorus (PHOS) Flex(R) reagent cartridge (DF61) The Phosphorus (PHOS) method used on the Dimension(R) clinical chemistry system is an in vitro diagnostic test intended for the quantitative measurement of phosphorus in human serum, plasma, and urine.","Lot numbers DC3078, exp 3/19/13; DA3092, exp 4/2/13; FB3109, exp 4/19/13; BC3127, exp 5/7/13; BB3152, exp 6/1/13; EC3166, exp 6/15/13; BB3190, exp 7/9/13; DA3212, exp 7/31/13; EA3233, exp 8/21/13; FB3260, exp 9/17/13; DA3319, exp 11/15/13; DA3320, exp 11/16/13; GC3337, exp 12/3/13; FB3346, exp 12/12/13; CB4014, exp 1/14/14; and FB4029, exp 1/29/14.",".","60,674","Siemens Healthcare Diagnostics has initiated a voluntary field action for Dimension(R) PHOS Flex(R) Reagent due to reagent interaction causing falsely depressed Creatinine results when EZCR is processed from open wells that are in close proximity to open wells of PHOS reagent.",2/22/2013,"02/22/2013",4/10/2013,"04/10/2013"
"Devices",64464,"Ongoing","Churchill Medical Systems, Inc.","Dover","NH","US","Voluntary: Firm Initiated","Letter","Nationwide Distribution including MO, IL, FL, PA, VA, MO, NY, NE, NH, and OH.","Z-0914-2013","Class II","Lifeguard Infusion Set with Smartsite, 20Ga, 1, CLGY-2010 Huber type needle set used for the infusion of medical fluids into implantable ports.","Lot #1210099",,"2340","The label on the device states that the item number is CLGY-2210 when the item number on the device label should read CLGY-2010. This is a 20Ga Huber needle set; however, the product label states the pouch contains a 22Ga set. ",1/21/2013,"01/21/2013",3/13/2013,"03/13/2013"
"Devices",64465,"Ongoing","Exactech, Inc.","Gainesville","FL","US","Voluntary: Firm Initiated","Letter","Nationwide Distribution including the states of FL, AL, LA, PA, VA, IL, OH, NY, NC, KS, TN, NJ, CO, GA, CA, MD, MN, IN, & Puerto Rico.","Z-0953-2013","Class II","Optetrak Logic Comprehensive Knee Prosthesis System, Proximal Tibial Spacer and screws, size 3.5, 8mm, Catalog # 02-012-42-3508.","Catalog # 02-012-42-3508All lot numbers",".","123 devices","A dimensional mismatch was identified which can potentially allow for interference between devices.",2/1/2013,"02/01/2013",3/27/2013,"03/27/2013"
"Food",64467,"Terminated","Domega NY International Co Ltd","Brooklyn","NY","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","New York City","F-1302-2013","Class I","GREEN DAY brand White Melon Seeds, Net Wt. 9.8 oz (280g) , UPC 6 868978 724120, Produce of P.R.C. --- Firms on Label: Manufacturer: Jiangmen Xinhui Parksun Food Co., Ltd. Add: Donggua Hill, Beltou Village, Qibao, Xinhui District, Jiangmen City, Guangdong -- Packed For: Domega NY International Co., ltd. 1915 West 13th Street Brooklyn, N.Y. 11223 --- Nutrition Facts: Serving Size (illegible) Servings Per Container 4 --- The product is packaged in a clear, plastic bag on a plastic tray insert.","MFD 09/30/2013 EXP 09/29/2014",,"37 cases (30 x 280 gram packages per case)","The product contained undeclared sulfites (1539 ppm) based on sampling & analysis by New York State Department of Agriculture & Markets.",2/25/2013,"02/25/2013",4/17/2013,"04/17/2013"
"Devices",64469,"Ongoing","Microbiologics Inc","Saint Cloud","MN","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution-USA including the states of CA, IN, MS, NY, OH, PA, and SD, and the countries of AUSTRALIA, AUSTRIA, UNITED ARAB EMIRATES, MALAYSIA, TAIWAN, JAPAN, TURKEY, BELGIUM, COLOMBIA, CANADA, SOUTH AFRICA, and VENEZUELA.","Z-1021-2013","Class II","Microbiologics KWIK-QC SLIDES ( KWIK-QC Acid Fast Stain Slides and KWIK-QC Mycobacterium Slides). Slide preparations serving as quality control challenges to demonstrate satisfactory performance of staining reagents. ","SL42-10 Lots 4239 to 4243SL43-10 Lots 4333 to 4337",,"396 boxes of 10 slides each.","Microbiologics Inc is initiating a voluntary recall on products KWIK-QC Acid Fast Stain Slide, SL42-10 and KWIK-QC Mycobacterium, SL43-10. These products are being recalled because the control organisms are not properly fixated on the slide, which may cause the user to unintentionally contaminate the patient area of the slide by flooding the control well with stain. This contamination could potentially lead to misdiagnosis and improper treatment of a patient. There have been no complaints or reports of death or injury due to this issue.",2/11/2013,"02/11/2013",4/3/2013,"04/03/2013"
"Devices",64471,"Ongoing","Molded Products Inc","Harlan","IA","US","Voluntary: Firm Initiated","Letter","Distributed to one customer in Michigan.","Z-0969-2013","Class II","Sterile Access & Return Line Set, 36'' Length, Part # UM-872-36. Intended for use with medically prescribed hemodialysis blood tubing.","Lot numbers: 80106 and 80106b",".","1200 sets","The recalled product leaks at the connection site.",6/19/2012,"06/19/2012",3/27/2013,"03/27/2013"
"Biologics",64472,"Terminated","Upstate New York Transplant Services","Buffalo","NY","US","Voluntary: Firm Initiated","Telephone","New York","B-1474-13","Class II","Platelets Pheresis Leukocytes Reduced","W28031280552; ",".","1","Blood product, with platelet yield below the specified minimum requirement, was distributed.",1/18/2013,"01/18/2013",6/12/2013,"06/12/2013"
"Biologics",64473,"Terminated","New York Blood Center, Inc.","New Brunswick","NJ","US","Voluntary: Firm Initiated","FAX","New York","B-1473-13","Class II","Red Blood Cells Leukocytes Reduced","W0470123710240; W0470123710240; (double unit)",".","2","Blood products, labeled leukoreduced without the assurance they met the criteria for leukoreduced products, were distributed.",2/19/2013,"02/19/2013",6/12/2013,"06/12/2013"
"Biologics",64474,"Terminated","Community Blood Centers of South Florida, Inc.","Hialeah","FL","US","Voluntary: Firm Initiated","Telephone","Switzerland; Florida","B-1380-13","Class II","Red Blood Cells","2625668; ",".","1","Blood products, collected from a donor whose suitability to donate was not adequately determined, were distributed.",2/12/2013,"02/12/2013",6/12/2013,"06/12/2013"
"Biologics",64474,"Terminated","Community Blood Centers of South Florida, Inc.","Hialeah","FL","US","Voluntary: Firm Initiated","Telephone","Switzerland; Florida","B-1381-13","Class III","Blood and Blood Products for Reprocessing","2625668; ",".","1","Blood products, collected from a donor whose suitability to donate was not adequately determined, were distributed.",2/12/2013,"02/12/2013",6/12/2013,"06/12/2013"
"Biologics",64475,"Terminated","DCI Biologicals LLC","Stillwater","OK","US","Voluntary: Firm Initiated","FAX","California","B-1472-13","Class II","Source Plasma","ST1068311; ST1068692; ST1068971; ST1070131; ST1070344; ST1070813; ST1071082; ST1072200; ST1072433; ST1072809; ST1073309; ST1073493; ST1074119; ST1074203; ST1074732; ST1067724; ST1067959; ",".","17","Blood products, collected from a donor who had not had an annual physical performed, were distributed.",1/10/2013,"01/10/2013",6/12/2013,"06/12/2013"
"Veterinary",64476,"Ongoing","United Pet Group Inc","Cincinnati","OH","US","Voluntary: Firm Initiated","Letter","Product was shipped to the following states: AZ, CA, FL, GA, IL, IN, MI, MO, NC, NJ, NV, NY, OH, PA, SC, WA & WI. Product was also shipped to Canada.","V-170-2013","Class I","eCotrition Grains & Greens, Nutritional Supplement for Parakeets A Diverse Blend of Garden Vegetables & Select Grains Vitamin & Mineral Enriched NEW WT. 8 OZ (226 g) Eight In One Pet Products Distributed by United Pet Group, Inc. Cincinnati, Ohio 45230 (800) 645-5154 www.eightinonepet.com UPC 0 26851 00505 ","Item # A505/11-20700 USE BY dates: 10/23/15 and 11/14/15",".","8,880/8 oz bags","The firm received notification from one of their ingredient suppliers that parsley they purchased may be contaminated with Salmonella.",2/27/2013,"02/27/2013",5/29/2013,"05/29/2013"
"Veterinary",64476,"Ongoing","United Pet Group Inc","Cincinnati","OH","US","Voluntary: Firm Initiated","Letter","Product was shipped to the following states: AZ, CA, FL, GA, IL, IN, MI, MO, NC, NJ, NV, NY, OH, PA, SC, WA & WI. Product was also shipped to Canada.","V-172-2013","Class I","eCotrition Grains & Greens, Nutritional Supplement for Cockatiels A Diverse Blend of Garden Fresh Vegetables & Select Grains Vitamin & Mineral Enriched NET WT. 6.5 OZ (184 g) Eight In One Pet Products Distributed by United Pet Group, Inc. Cincinnati, Ohio 45230 (800) 645-5154 www.eightinonepet.com UPC 0 26851 00512","Item # B512/11-20711 USE BY date: 12/05/15",".","96/6.5 oz bags","The firm received notification from one of their ingredient suppliers that parsley they purchased may be contaminated with Salmonella.",2/27/2013,"02/27/2013",5/29/2013,"05/29/2013"
"Veterinary",64476,"Ongoing","United Pet Group Inc","Cincinnati","OH","US","Voluntary: Firm Initiated","Letter","Product was shipped to the following states: AZ, CA, FL, GA, IL, IN, MI, MO, NC, NJ, NV, NY, OH, PA, SC, WA & WI. Product was also shipped to Canada.","V-171-2013","Class I","eCotrition Grains & Greens, Nutritional Supplement for Canaries and Finches A Diverse Blend of Garden Fresh Vegetables & Select Grains Vitamin & Mineral Enriched NET WT. 8 OZ (226 g) Eight In One Pet Products Distributed by United Pet Group, Inc. Cincinnati, Ohio 45230 (800) 645-5154 www.eightinonepet.com UPC 0 26851 00546","Item # C546/11-20712 - USE BY date: 10/16/15",".","264/8 oz bags","The firm received notification from one of their ingredient suppliers that parsley they purchased may be contaminated with Salmonella.",2/27/2013,"02/27/2013",5/29/2013,"05/29/2013"
"Veterinary",64476,"Ongoing","United Pet Group Inc","Cincinnati","OH","US","Voluntary: Firm Initiated","Letter","Product was shipped to the following states: AZ, CA, FL, GA, IL, IN, MI, MO, NC, NJ, NV, NY, OH, PA, SC, WA & WI. Product was also shipped to Canada.","V-169-2013","Class I","Ultra Blend Gourmet, Food for Parakeets (80 oz bag), A Harvest Celebration FOOD FOR PARAKEETS, NET.WT 80 OZ (5 LBS) Eight In One Pet Products Distributed by United Pet Group, Inc., Cincinnati, OH 45230 (800) 645-5154 www.eightinonepet.com UPC 0 26851 00904","Item # A904/056-0904-01 - USE BY dates: 07/20/15 and 10/20/15",".","6,630/80 oz bags","The firm received notification from one of their ingredient suppliers that parsley they purchased may be contaminated with Salmonella.",2/27/2013,"02/27/2013",5/29/2013,"05/29/2013"
"Devices",64477,"Terminated","Keystone Dental Inc","Burlington","MA","US","Voluntary: Firm Initiated","FAX","Nationwide Distribution including CA, IN, MA, MD, MN, MI, , NH, NY, NC, PA, and WI.","Z-0924-2013","Class II","Genesis Straight Esthetic 5.0 mm 3. mm Cuff AbutmentPart Number: G71205 Genesis implant for single stage or two stage surgical procedures all types of of bone in partially or fully edentulous mandibles and maxillae. ","Lot Number: 2385Exp Date: 09/2013",,"22 units","Mislabeled: Genesis Straight Esthetic 4.0mm Contour ,1mm cuff labeled as Genesis Straight Esthetic 5.0 mm, 3mm cuff abutment",7/5/2011,"07/05/2011",3/20/2013,"03/20/2013"
"Devices",64477,"Terminated","Keystone Dental Inc","Burlington","MA","US","Voluntary: Firm Initiated","FAX","Nationwide Distribution including CA, IN, MA, MD, MN, MI, , NH, NY, NC, PA, and WI.","Z-0923-2013","Class II","Genesis Straight Esthetic 4.0 mm 1mm Cuff AbutmentPart Number: G71200 Genesis implant for single stage or two stage surgical procedures all types of of bone in partially or fully edentulous mandibles and maxillae. ","Lot Number: 2376Exp Date: 09/2013",,"35 units","Mislabeled: Genesis Straight Esthetic 5.0mm Contour ,3mm cuff labeled as Genesis Straight Esthetic 4.0 mm, 1 mm cuff abutment,",7/5/2011,"07/05/2011",3/20/2013,"03/20/2013"
"Devices",64478,"Ongoing","Lifescan Inc","Milpitas","CA","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution-USA (nationwide) including DC and Puerto Rico and the states of AK, AL, AR, AZ, CA, CO, CT, DE, FL, GA, HI, IA, 10, IL, IN, KS, KY, LA, MA, MD, ME, Ml, MN, MO, MS, MT, NC, NO, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, SO, TN, TX, UT, VA, VI, VT, WA, WI,WV, and WY, and the countries of Russia and Ukraine.","Z-1130-2013","Class II","LifeScan brand OneTouch Select Control Solution, Part Number/Model #: 02168902. Testing of Blood Glucose Levels.","2AA2101, Exp. Date: 9-30-2014; 2AA2102, Exp. Date: 10-31-2-14 ",".","132,301 units total","When OneTouch Ultra and OneTouch Select test strips are tested with Ultra and Select control solution the meter may display a result outside the control solution test range printed on the strip vial label even though the system is working properly.",2/25/2013,"02/25/2013",4/24/2013,"04/24/2013"
"Devices",64478,"Ongoing","Lifescan Inc","Milpitas","CA","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution-USA (nationwide) including DC and Puerto Rico and the states of AK, AL, AR, AZ, CA, CO, CT, DE, FL, GA, HI, IA, 10, IL, IN, KS, KY, LA, MA, MD, ME, Ml, MN, MO, MS, MT, NC, NO, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, SO, TN, TX, UT, VA, VI, VT, WA, WI,WV, and WY, and the countries of Russia and Ukraine.","Z-1129-2013","Class II","LifeScan brand OneTouch Ultra Control Solution, Part Numbers/Model Numbers: 01045808, 02141603. Testing of Blood Glucose Levels.","2AA2G01, Exp. Date: 7-31-2014; 2AA2G02, Exp. Date: 7-31-2014; 2AA2G03, Exp. Date: 8-31-2014; 3AA2G04, Exp. Date: 12-31-2014; 3AA2G05, Exp. Date: 12-31-2014 ",".","132,301 units total","When OneTouch Ultra and OneTouch Select test strips are tested with Ultra and Select control solution the meter may display a result outside the control solution test range printed on the strip vial label even though the system is working properly.",2/25/2013,"02/25/2013",4/24/2013,"04/24/2013"
"Devices",64479,"Ongoing","Natus Neurology Incorporated","Middleton","WI","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution - USA Nationwide including the states of CA, FL, LA, MD, MS, MO, NJ, NY, PA, TX and the country of AUSTRALIA. BAHRAIN BRAZIL CANADA Country DENMARK EGYPT GERMANY HONG KONG INDIA INDONESIA IRELAND ITALY JAPAN KOREA KUWAIT MALAYSIA MEXICO NETHERLANDS ROMANIA RUSSIA SINGAPORE SPAIN SWITZERLAND TAIWAN THAILAND TURKEY UNITED KINGDOM URUGUAY VIET NAM","Z-0946-2013","Class II","Nicolet EEG Wireless Amplifier 32/64 Channel. Catalog/Part Numbers : 515-015400 for the 32 channel amplifier and 515-015500 for the 64 channel amplifier. Product Usage: The Nicolet Wireless EEG Amplifier is intended to be used as a front end amplifier to acquire, store, and transmit electrophysiological signals in a wired or wireless mode for the Nicolet Neurodiagnostic system. ","C110318004C110318027 C110815014 C110815025 C110519011 C110318029 C110318010 C110318028 C110318030 C110318019 C110318006 C110318013 C110519022 C110519021 C110323024 C110323039 C110323037 C110323034 C110519003 C110323011 C110323007 C110815003 C110323040 C110815030 C110815015 C110517040 C110815026 C110519031 C110519030 C110513015 C110519035 C110318009 C110815020 C110519023 C110519023 C110815001 C110519010 C110519017 C110318018 61855 C110519002 C110323006 38249 C110815007 C110323036 C110519007 C110519012 C110519027 C110318008 C110318016 C110318026 C110318027 C110519008 C110519009 C110815023 C110815013 C110519034 C110519029 C110323050 C110118018 C110519043 C110815027 C110519005 C110519026 C110579013 C110519045 C110519015 C110201021 C110318001 C110519050 C110323002 C110519014 C110519033 C110318012 C110519038 C110519042 C110318023 C110519020 RG100512M C110519046 C110519037 C110519019 C110519007 C110318016 C110318002 C110815016 C110815012 RC110125M C110323018 C110815024 A4312 & A4314 C110318014 C110318011 C110318015 34902 C110815011 C110309001 C110519002 A42A0 C110318025 C110519036 C110519028 C110519024 C110519013 C110318005 ",,"114 (31 USA; 83 OUS)","Natus Neurology Incorporated is recalling the Nicolet EEG Wireless Amplifier which may overheat and become uncomfortable to touch around the area of the on/off button. The overheating may result in discomfort ranging from too hot up to the potential for a burn. ",2/27/2013,"02/27/2013",3/20/2013,"03/20/2013"
"Drugs",64480,"Ongoing","Teva Pharmaceuticals USA, Inc.","Sellersville","PA","US","Voluntary: Firm Initiated","Letter","Nationwide","D-247-2013","Class II","Cefdinir for Oral Suspension, 125 mg/5 mL, packaged in a) 60 mL bottle (NDC 0093-4136-64); b) 100 mL bottle (NDC 0093-4136-73), Rx only, Teva Pharmaceuticals USA, Sellersville, PA 18960.","a) Lot #: 30304253A, Exp 12/13; b) Lot #: 30304144A, Exp 12/13 and 30304477A, Exp 03/14",,"62,187 bottles","Defective Container: This recall is being carried out due to the potential for improperly sealed bottles.",2/26/2013,"02/26/2013",4/17/2013,"04/17/2013"
"Drugs",64481,"Ongoing","Hospira Inc.","Lake Forest","IL","US","Voluntary: Firm Initiated","Letter","Nationwide","D-243-2013","Class II","0.9% Sodium Chloride Injection, USP, 50 mL, Manufactured by Hospira, Inc., Lake Forest, IL 60045, NDC 0409-7984-36 Hospira, Inc., Lake Forest, IL 60045","Lot #: 22-028-JT Exp 04/14",".","624,240 units","Lack of Assurance of Sterility: The product is being recall due to the product lot being incorrectly released without meeting product specifications. There is the potential for the solution to leak from the administrative port to the fill tube seal.",2/18/2013,"02/18/2013",4/10/2013,"04/10/2013"
"Drugs",64482,"Ongoing","Hospira Inc.","Lake Forest","IL","US","Voluntary: Firm Initiated","Letter","Nationwide.","D-206-2013","Class II","METRONIDazole Injection, USP 500 mg (5 mg/mL), 100 mL Bag, Rx only, Hospira, Inc. Lake Forest, IL 60045 (NDC 0409-7811-24)","Lot code 12-074-JT Exp 12/13",".","567,624 bags","Lack of Assurance of Sterility: There is the potential for the solution to leak from the administrative port to the fill tube seal.",2/15/2013,"02/15/2013",3/27/2013,"03/27/2013"
"Food",64483,"Ongoing","Koda Farms Inc","South Dos Palos","CA","US","Voluntary: Firm Initiated","Letter","NY, MD, CA, HI, WA,","F-1139-2013","Class II","Mochiko Blue Star Sweet Rice Flour, Net Wt 50 lb. or packaged in 1 lb bags.Koda Farms Milling, Inc. South Dos Palos, CA. 93665","Lot numbers F307, F308, F309, F311, F314, F315, F317, F322, F323.50 Lb bag UPC 0 74823-00023-3; 1 lb gab UPC-0-74823-00021-9.",,"357x 50 lb bags; 119172 x 1 lb bags.","Koda Farms received a report from a customer that a hard yellow material was found in dough made with rice flour from Koda Farms. This is an expansion of the recall of two lots of rice flour that commenced on February 15, 2013 to include additional lots after a report of the same material found in an earlier lot of rice flour.",2/27/2013,"02/27/2013",3/20/2013,"03/20/2013"
"Biologics",64484,"Terminated","Blood Assurance Inc","Chattanooga","TN","US","Voluntary: Firm Initiated","FAX","Tennessee","B-1383-13","Class II","Plasma Frozen within 24 hours (FP24)","W043209019747; ",".","1","Blood products, collected from a donor whose suitability to donate was not adequately determined, were distributed.",2/12/2012,"02/12/2012",6/12/2013,"06/12/2013"
"Biologics",64484,"Terminated","Blood Assurance Inc","Chattanooga","TN","US","Voluntary: Firm Initiated","FAX","Tennessee","B-1382-13","Class II","Red Blood Cells Leukocytes Reduced","W043209019747; ",".","1","Blood products, collected from a donor whose suitability to donate was not adequately determined, were distributed.",2/12/2012,"02/12/2012",6/12/2013,"06/12/2013"
"Devices",64485,"Ongoing","Orthohelix Surgical Designs Inc","Medina","OH","US","Voluntary: Firm Initiated","Letter","Nationwide Distribution including the states of CA, CO, IL, MI, MD, NC, NM, OH, OK, PA, SD, TX, UT, VA, WA and WI.","Z-0975-2013","Class II","Intraosseous Fixation System (IFS) 1.7 mm, 2.0 mm & 2.5 mm Cannulated Drill Bit. Intended to stabilize and aid in fixation of fractures.","Part #: IFS-072-17-C, Lot #: 2399041; Part #: IFS-72-20-C, Lot #: 2399051 & Lot #: 2399051R and Part #: IFS-072-25-C, Lot #: 2399061.",,"Lot # 2399041, 97 pcs; Lot # 2399051, 143 pcs; Lot # 2399051R, 4 pcs & Lot # 2399061, 119 pcs","The firm was notified by a customer that there was a burr on the inside end of the drill bit resulting in the drill bit not fitting over the associated guide wire.",10/30/2012,"10/30/2012",4/3/2013,"04/03/2013"
"Devices",64486,"Ongoing","Bacterin International, Inc.","Belgrade","MT","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","USA Nationwide Distribution","Z-1138-2013","Class II","OsteoSelect DBM Putty Product Usage: Orthopedic bone filler ","B100164 and B110115",".","165","The firm's retesting procedure was not validated.",2/21/2013,"02/21/2013",4/24/2013,"04/24/2013"
"Food",64487,"Ongoing","NuGo Nutrition HQ","Pittsburgh","PA","US","Voluntary: Firm Initiated","Letter","Product distribution was limited to Canada.","F-1209-2013","Class I","NuGo Free Trail Mix Bars, UPC 6 91535 45301 2","B12233A, best by 20 No 13",".","90 cases of 96 bars each","NuGo became aware of the possible inadvertent presence of milk in the NuGo Free Trail Mix Bar.",2/21/2013,"02/21/2013",3/27/2013,"03/27/2013"
"Biologics",64488,"Terminated","Dept Of The Navy, Naval Medical Center","Portsmouth","VA","US","Voluntary: Firm Initiated","FAX","Virginia","B-1360-13","Class II","Red Blood Cells Leukocytes Reduced","W021512002231; ",".","1","Blood product, collected from a donor for whom donor suitability was not adequately determined, was distributed.",9/24/2012,"09/24/2012",6/12/2013,"06/12/2013"
"Biologics",64489,"Terminated","Dept Of The Navy, Naval Medical Center","Portsmouth","VA","US","Voluntary: Firm Initiated","FAX","Virginia","B-1361-13","Class II","Red Blood Cells Leukocytes Reduced","W021512001845; W021512004439; ",".","2","Blood products, collected from a donor in which donor suitability was not adequately determined, were distributed.",9/24/2012,"09/24/2012",6/12/2013,"06/12/2013"
"Biologics",64490,"Terminated","Bio-Rad Medical Diagnostics GmbH","Dreieich",,"DE","Voluntary: Firm Initiated","Letter","Germany","B-1261-13","Class II","Reagent Red Blood Cells","830301100",".","1","Biotest reagent A1 red blood cell, with higher than expected cell concentration, was distributed. ",2/19/2013,"02/19/2013",4/10/2013,"04/10/2013"
"Biologics",64491,"Terminated","West Tennessee Regional Blood Center Inc","Jackson","TN","US","Voluntary: Firm Initiated","Letter","Tennessee","B-1362-13","Class II","Red Blood Cells Leukocytes Reduced","W040812117735; ",".","1","Blood product, which was collected from a donor who traveled to a malarial endemic area, was distributed.",2/11/2013,"02/11/2013",6/12/2013,"06/12/2013"
"Biologics",64492,"Terminated","Dept Of The Navy, Naval Medical Center","Portsmouth","VA","US","Voluntary: Firm Initiated","FAX","New Jersey","B-1363-13","Class II","Red Blood Cells Leukocytes Reduced","W021512004565; ",".","1","Blood product, collected from a donor, whose suitability to donate was not adequately determined, was distributed.",9/25/2012,"09/25/2012",6/12/2013,"06/12/2013"
"Food",64493,"Completed","Publix Super Markets, Inc.","Lakeland","FL","US","Voluntary: Firm Initiated","E-Mail","Florida","F-1148-2013","Class I","Publix 7 inch Dec. Butter cream w/Filling CakeScale ID Number * 002-19722-00000 *The last five digits of the scale ID number contain the unit price. For example $4.99 would have the last five digits ending 00499. ","Recalled products were distributed from November 11, 2012 through November 15, 2012.",,,"Maplehurst Deli-Bake South Inc. the cake supplier notified Publix Super market of a contamination with Listeria Monocytogenes on 11/15/2012.",11/15/2012,"11/15/2012",3/20/2013,"03/20/2013"
"Food",64493,"Completed","Publix Super Markets, Inc.","Lakeland","FL","US","Voluntary: Firm Initiated","E-Mail","Florida","F-1186-2013","Class I","Publix Midnight Fudge Fantasy cakeScale ID Number * 002-94254-00000 *The last five digits of the scale ID number contain the unit price. For example $4.99 would have the last five digits ending 00499. ","Recalled products were distributed from November 11, 2012 through November 15, 2012.",,,"Maplehurst Deli-Bake South Inc. the cake supplier notified Publix Super market of a contamination with Listeria Monocytogenes on 11/15/2012.",11/15/2012,"11/15/2012",3/20/2013,"03/20/2013"
"Food",64493,"Completed","Publix Super Markets, Inc.","Lakeland","FL","US","Voluntary: Firm Initiated","E-Mail","Florida","F-1169-2013","Class I","Publix W/T Blackout layer cakeScale ID Number * 002-95322-00000 *The last five digits of the scale ID number contain the unit price. For example $4.99 would have the last five digits ending 00499. ","Recalled products were distributed from November 11, 2012 through November 15, 2012.",,,"Maplehurst Deli-Bake South Inc. the cake supplier notified Publix Super market of a contamination with Listeria Monocytogenes on 11/15/2012.",11/15/2012,"11/15/2012",3/20/2013,"03/20/2013"
"Food",64493,"Completed","Publix Super Markets, Inc.","Lakeland","FL","US","Voluntary: Firm Initiated","E-Mail","Florida","F-1174-2013","Class I","Publix 7 inch Chocolate w Pistachio layer cakeScale ID Number * 002-95657-00000 *The last five digits of the scale ID number contain the unit price. For example $4.99 would have the last five digits ending 00499. ","Recalled products were distributed from November 11, 2012 through November 15, 2012.",,,"Maplehurst Deli-Bake South Inc. the cake supplier notified Publix Super market of a contamination with Listeria Monocytogenes on 11/15/2012.",11/15/2012,"11/15/2012",3/20/2013,"03/20/2013"
"Food",64493,"Completed","Publix Super Markets, Inc.","Lakeland","FL","US","Voluntary: Firm Initiated","E-Mail","Florida","F-1165-2013","Class I","Publix 7 inch Fudge iced Choc DEC cakeScale ID Number * 002-94432-00000 *The last five digits of the scale ID number contain the unit price. For example $4.99 would have the last five digits ending 00499. ","Recalled products were distributed from November 11, 2012 through November 15, 2012.",,,"Maplehurst Deli-Bake South Inc. the cake supplier notified Publix Super market of a contamination with Listeria Monocytogenes on 11/15/2012.",11/15/2012,"11/15/2012",3/20/2013,"03/20/2013"
"Food",64493,"Completed","Publix Super Markets, Inc.","Lakeland","FL","US","Voluntary: Firm Initiated","E-Mail","Florida","F-1146-2013","Class I","Publix 7 inch Cookies Cream Layer CakeScale ID Number * 002-16466-00000 *The last five digits of the scale ID number contain the unit price. For example $4.99 would have the last five digits ending 00499. ","Recalled products were distributed from November 11, 2012 through November 15, 2012.",,,"Maplehurst Deli-Bake South Inc. the cake supplier notified Publix Super market of a contamination with Listeria Monocytogenes on 11/15/2012.",11/15/2012,"11/15/2012",3/20/2013,"03/20/2013"
"Food",64493,"Completed","Publix Super Markets, Inc.","Lakeland","FL","US","Voluntary: Firm Initiated","E-Mail","Florida","F-1171-2013","Class I","Publix 7inch Checkerboard Whole cakeScale ID Number * 002-95325-00000 *The last five digits of the scale ID number contain the unit price. For example $4.99 would have the last five digits ending 00499. ","Recalled products were distributed from November 11, 2012 through November 15, 2012.",,,"Maplehurst Deli-Bake South Inc. the cake supplier notified Publix Super market of a contamination with Listeria Monocytogenes on 11/15/2012.",11/15/2012,"11/15/2012",3/20/2013,"03/20/2013"
"Food",64493,"Completed","Publix Super Markets, Inc.","Lakeland","FL","US","Voluntary: Firm Initiated","E-Mail","Florida","F-1152-2013","Class I","Publix 7 inch Cream Cheese VAN DEC cakeScale ID Number * 002-92096-00000 *The last five digits of the scale ID number contain the unit price. For example $4.99 would have the last five digits ending 00499. ","Recalled products were distributed from November 11, 2012 through November 15, 2012.",,,"Maplehurst Deli-Bake South Inc. the cake supplier notified Publix Super market of a contamination with Listeria Monocytogenes on 11/15/2012.",11/15/2012,"11/15/2012",3/20/2013,"03/20/2013"
"Food",64493,"Completed","Publix Super Markets, Inc.","Lakeland","FL","US","Voluntary: Firm Initiated","E-Mail","Florida","F-1156-2013","Class I","Publix Dulce de Leche Bon Bon cakeScale ID Number * 002-94003-00000 *The last five digits of the scale ID number contain the unit price. For example $4.99 would have the last five digits ending 00499. ","Recalled products were distributed from November 11, 2012 through November 15, 2012.",,,"Maplehurst Deli-Bake South Inc. the cake supplier notified Publix Super market of a contamination with Listeria Monocytogenes on 11/15/2012.",11/15/2012,"11/15/2012",3/20/2013,"03/20/2013"
"Food",64493,"Completed","Publix Super Markets, Inc.","Lakeland","FL","US","Voluntary: Firm Initiated","E-Mail","Florida","F-1185-2013","Class I","Publix Caramel Pecan Crunch cakeScale ID Number * 002-94301-00000 *The last five digits of the scale ID number contain the unit price. For example $4.99 would have the last five digits ending 00499. ","Recalled products were distributed from November 11, 2012 through November 15, 2012.",,,"Maplehurst Deli-Bake South Inc. the cake supplier notified Publix Super market of a contamination with Listeria Monocytogenes on 11/15/2012.",11/15/2012,"11/15/2012",3/20/2013,"03/20/2013"
"Food",64493,"Completed","Publix Super Markets, Inc.","Lakeland","FL","US","Voluntary: Firm Initiated","E-Mail","Florida","F-1183-2013","Class I","Publix 7 inch German Chocolate cakeScale ID Number * 002-95958-00000 *The last five digits of the scale ID number contain the unit price. For example $4.99 would have the last five digits ending 00499. ","Recalled products were distributed from November 11, 2012 through November 15, 2012.",,,"Maplehurst Deli-Bake South Inc. the cake supplier notified Publix Super market of a contamination with Listeria Monocytogenes on 11/15/2012.",11/15/2012,"11/15/2012",3/20/2013,"03/20/2013"
"Food",64493,"Completed","Publix Super Markets, Inc.","Lakeland","FL","US","Voluntary: Firm Initiated","E-Mail","Florida","F-1168-2013","Class I","Publix 7 inch Buttercream 1/2-1/2 cakeScale ID Number * 002-94502-00000 *The last five digits of the scale ID number contain the unit price. For example $4.99 would have the last five digits ending 00499. ","Recalled products were distributed from November 11, 2012 through November 15, 2012.",,,"Maplehurst Deli-Bake South Inc. the cake supplier notified Publix Super market of a contamination with Listeria Monocytogenes on 11/15/2012.",11/15/2012,"11/15/2012",3/20/2013,"03/20/2013"
"Food",64493,"Completed","Publix Super Markets, Inc.","Lakeland","FL","US","Voluntary: Firm Initiated","E-Mail","Florida","F-1182-2013","Class I","Publix 7 inch Chocolate with Mint butter cream layer cakeScale ID Number * 002-95955-00000 *The last five digits of the scale ID number contain the unit price. For example $4.99 would have the last five digits ending 00499. ","Recalled products were distributed from November 11, 2012 through November 15, 2012.",,,"Maplehurst Deli-Bake South Inc. the cake supplier notified Publix Super market of a contamination with Listeria Monocytogenes on 11/15/2012.",11/15/2012,"11/15/2012",3/20/2013,"03/20/2013"
"Food",64493,"Completed","Publix Super Markets, Inc.","Lakeland","FL","US","Voluntary: Firm Initiated","E-Mail","Florida","F-1147-2013","Class I","Publix 7inch W/T Iced Chocolate Layer cakeScale ID Number * 002-16467-00000 *The last five digits of the scale ID number contain the unit price. For example $4.99 would have the last five digits ending 00499. ","Recalled products were distributed from November 11, 2012 through November 15, 2012.",,,"Maplehurst Deli-Bake South Inc. the cake supplier notified Publix Super market of a contamination with Listeria Monocytogenes on 11/15/2012.",11/15/2012,"11/15/2012",3/20/2013,"03/20/2013"
"Food",64493,"Completed","Publix Super Markets, Inc.","Lakeland","FL","US","Voluntary: Firm Initiated","E-Mail","Florida","F-1175-2013","Class I","Publix 7 inch Ripple layer cakeScale ID Number * 002-95658-00000 *The last five digits of the scale ID number contain the unit price. For example $4.99 would have the last five digits ending 00499. ","Recalled products were distributed from November 11, 2012 through November 15, 2012.",,,"Maplehurst Deli-Bake South Inc. the cake supplier notified Publix Super market of a contamination with Listeria Monocytogenes on 11/15/2012.",11/15/2012,"11/15/2012",3/20/2013,"03/20/2013"
"Food",64493,"Completed","Publix Super Markets, Inc.","Lakeland","FL","US","Voluntary: Firm Initiated","E-Mail","Florida","F-1179-2013","Class I","Publix 7 inch Chocolate with Cherry Buttercream layer cakeScale ID Number * 002-95767-00000 *The last five digits of the scale ID number contain the unit price. For example $4.99 would have the last five digits ending 00499. ","Recalled products were distributed from November 11, 2012 through November 15, 2012.",,,"Maplehurst Deli-Bake South Inc. the cake supplier notified Publix Super market of a contamination with Listeria Monocytogenes on 11/15/2012.",11/15/2012,"11/15/2012",3/20/2013,"03/20/2013"
"Food",64493,"Completed","Publix Super Markets, Inc.","Lakeland","FL","US","Voluntary: Firm Initiated","E-Mail","Florida","F-1162-2013","Class I","Publix Latte Blast cakeScale ID Number * 002-94162-00000 *The last five digits of the scale ID number contain the unit price. For example $4.99 would have the last five digits ending 00499. ","Recalled products were distributed from November 11, 2012 through November 15, 2012.",,,"Maplehurst Deli-Bake South Inc. the cake supplier notified Publix Super market of a contamination with Listeria Monocytogenes on 11/15/2012.",11/15/2012,"11/15/2012",3/20/2013,"03/20/2013"
"Food",64493,"Completed","Publix Super Markets, Inc.","Lakeland","FL","US","Voluntary: Firm Initiated","E-Mail","Florida","F-1154-2013","Class I","Publix 7inch Cream Cheese 1/2 & 1/2 DEC cakeScale ID Number * 002-92099-00000 *The last five digits of the scale ID number contain the unit price. For example $4.99 would have the last five digits ending 00499. ","Recalled products were distributed from November 11, 2012 through November 15, 2012.",,,"Maplehurst Deli-Bake South Inc. the cake supplier notified Publix Super market of a contamination with Listeria Monocytogenes on 11/15/2012.",11/15/2012,"11/15/2012",3/20/2013,"03/20/2013"
"Food",64493,"Completed","Publix Super Markets, Inc.","Lakeland","FL","US","Voluntary: Firm Initiated","E-Mail","Florida","F-1176-2013","Class I","Publix 7 inch Chocolate with Mocha layer cakeScale ID Number * 002-95697-00000 *The last five digits of the scale ID number contain the unit price. For example $4.99 would have the last five digits ending 00499."," Recalled products were distributed from November 11, 2012 through November 15, 2012.",,,"Maplehurst Deli-Bake South Inc. the cake supplier notified Publix Super market of a contamination with Listeria Monocytogenes on 11/15/2012.",11/15/2012,"11/15/2012",3/20/2013,"03/20/2013"
"Food",64493,"Completed","Publix Super Markets, Inc.","Lakeland","FL","US","Voluntary: Firm Initiated","E-Mail","Florida","F-1158-2013","Class I","Publix Chocolate Ganache Bon Bon cakeScale ID Number * 002-94098-00000 *The last five digits of the scale ID number contain the unit price. For example $4.99 would have the last five digits ending 00499. ","Recalled products were distributed from November 11, 2012 through November 15, 2012.",,,"Maplehurst Deli-Bake South Inc. the cake supplier notified Publix Super market of a contamination with Listeria Monocytogenes on 11/15/2012.",11/15/2012,"11/15/2012",3/20/2013,"03/20/2013"
"Food",64493,"Completed","Publix Super Markets, Inc.","Lakeland","FL","US","Voluntary: Firm Initiated","E-Mail","Florida","F-1161-2013","Class I","Publix 7 inch Raspberry Sacher Torte Scale ID Number * 002-94132-00000 *The last five digits of the scale ID number contain the unit price. For example $4.99 would have the last five digits ending 00499. ","Recalled products were distributed from November 11, 2012 through November 15, 2012.",,,"Maplehurst Deli-Bake South Inc. the cake supplier notified Publix Super market of a contamination with Listeria Monocytogenes on 11/15/2012.",11/15/2012,"11/15/2012",3/20/2013,"03/20/2013"
"Food",64493,"Completed","Publix Super Markets, Inc.","Lakeland","FL","US","Voluntary: Firm Initiated","E-Mail","Florida","F-1159-2013","Class I","Publix 7 inch Chocolate Ganache Grandeur cakeScale ID Number * 002-94130-00000 *The last five digits of the scale ID number contain the unit price. For example $4.99 would have the last five digits ending 00499. ","Recalled products were distributed from November 11, 2012 through November 15, 2012.",,,"Maplehurst Deli-Bake South Inc. the cake supplier notified Publix Super market of a contamination with Listeria Monocytogenes on 11/15/2012.",11/15/2012,"11/15/2012",3/20/2013,"03/20/2013"
"Food",64493,"Completed","Publix Super Markets, Inc.","Lakeland","FL","US","Voluntary: Firm Initiated","E-Mail","Florida","F-1187-2013","Class I","Publix Peanut Butter Fudge Fix cakeScale ID Number * 002-94599-00000 *The last five digits of the scale ID number contain the unit price. For example $4.99 would have the last five digits ending 00499. ","Recalled products were distributed from November 11, 2012 through November 15, 2012.",,,"Maplehurst Deli-Bake South Inc. the cake supplier notified Publix Super market of a contamination with Listeria Monocytogenes on 11/15/2012.",11/15/2012,"11/15/2012",3/20/2013,"03/20/2013"
"Food",64493,"Completed","Publix Super Markets, Inc.","Lakeland","FL","US","Voluntary: Firm Initiated","E-Mail","Florida","F-1153-2013","Class I","Publix 7 inch Cream Cheese CHOC DEC cakeScale ID Number * 002-92097-00000 *The last five digits of the scale ID number contain the unit price. For example $4.99 would have the last five digits ending 00499. ","Recalled products were distributed from November 11, 2012 through November 15, 2012.",,,"Maplehurst Deli-Bake South Inc. the cake supplier notified Publix Super market of a contamination with Listeria Monocytogenes on 11/15/2012.",11/15/2012,"11/15/2012",3/20/2013,"03/20/2013"
"Food",64493,"Completed","Publix Super Markets, Inc.","Lakeland","FL","US","Voluntary: Firm Initiated","E-Mail","Florida","F-1149-2013","Class I","Publix 7 inch Dec. Whip Topping with filling cakeScale ID Number * 002-19734-00000 *The last five digits of the scale ID number contain the unit price. For example $4.99 would have the last five digits ending 00499. ","Recalled products were distributed from November 11, 2012 through November 15, 2012.",,,"Maplehurst Deli-Bake South Inc. the cake supplier notified Publix Super market of a contamination with Listeria Monocytogenes on 11/15/2012.",11/15/2012,"11/15/2012",3/20/2013,"03/20/2013"
"Food",64493,"Completed","Publix Super Markets, Inc.","Lakeland","FL","US","Voluntary: Firm Initiated","E-Mail","Florida","F-1151-2013","Class I","Publix 7inch Dec. Cream Cheese Iced W/F cakeScale ID Number * 002-19759-00000 *The last five digits of the scale ID number contain the unit price. For example $4.99 would have the last five digits ending 00499. ","Recalled products were distributed from November 11, 2012 through November 15, 2012.",,,"Maplehurst Deli-Bake South Inc. the cake supplier notified Publix Super market of a contamination with Listeria Monocytogenes on 11/15/2012.",11/15/2012,"11/15/2012",3/20/2013,"03/20/2013"
"Food",64493,"Completed","Publix Super Markets, Inc.","Lakeland","FL","US","Voluntary: Firm Initiated","E-Mail","Florida","F-1155-2013","Class I","Publix Chocolate Ganache cakeScale ID Number * 002-94078-00000 *The last five digits of the scale ID number contain the unit price. For example $4.99 would have the last five digits ending 00499. ","Recalled products were distributed from November 11, 2012 through November 15, 2012.",,,"Maplehurst Deli-Bake South Inc. the cake supplier notified Publix Super market of a contamination with Listeria Monocytogenes on 11/15/2012.",11/15/2012,"11/15/2012",3/20/2013,"03/20/2013"
"Food",64493,"Completed","Publix Super Markets, Inc.","Lakeland","FL","US","Voluntary: Firm Initiated","E-Mail","Florida","F-1160-2013","Class I","Publix 7 inch Buttercream Choc Dec cakeScale ID Number * 002-943330-00000 *The last five digits of the scale ID number contain the unit price. For example $4.99 would have the last five digits ending 00499. ","Recalled products were distributed from November 11, 2012 through November 15, 2012.",,,"Maplehurst Deli-Bake South Inc. the cake supplier notified Publix Super market of a contamination with Listeria Monocytogenes on 11/15/2012.",11/15/2012,"11/15/2012",3/20/2013,"03/20/2013"
"Food",64493,"Completed","Publix Super Markets, Inc.","Lakeland","FL","US","Voluntary: Firm Initiated","E-Mail","Florida","F-1166-2013","Class I","Publix 7inch Ice Cream Choc Dec cakeScale ID Number * 002-94468-00000 *The last five digits of the scale ID number contain the unit price. For example $4.99 would have the last five digits ending 00499. ","Recalled products were distributed from November 11, 2012 through November 15, 2012.",,,"Maplehurst Deli-Bake South Inc. the cake supplier notified Publix Super market of a contamination with Listeria Monocytogenes on 11/15/2012.",11/15/2012,"11/15/2012",3/20/2013,"03/20/2013"
"Food",64493,"Completed","Publix Super Markets, Inc.","Lakeland","FL","US","Voluntary: Firm Initiated","E-Mail","Florida","F-1164-2013","Class I","Publix 7 inch Whipped Topping 1/2 & 1/2 cakeScale ID Number * 002-94420-00000 *The last five digits of the scale ID number contain the unit price. For example $4.99 would have the last five digits ending 00499. ","Recalled products were distributed from November 11, 2012 through November 15, 2012.",,,"Maplehurst Deli-Bake South Inc. the cake supplier notified Publix Super market of a contamination with Listeria Monocytogenes on 11/15/2012.",11/15/2012,"11/15/2012",3/20/2013,"03/20/2013"
"Food",64493,"Completed","Publix Super Markets, Inc.","Lakeland","FL","US","Voluntary: Firm Initiated","E-Mail","Florida","F-1178-2013","Class I","Publix 7 inch Chocolate with Buttercream layer cakeScale ID Number * 002-95664-00000 *The last five digits of the scale ID number contain the unit price. For example $4.99 would have the last five digits ending 00499. ","Recalled products were distributed from November 11, 2012 through November 15, 2012.",,,"Maplehurst Deli-Bake South Inc. the cake supplier notified Publix Super market of a contamination with Listeria Monocytogenes on 11/15/2012.",11/15/2012,"11/15/2012",3/20/2013,"03/20/2013"
"Food",64493,"Completed","Publix Super Markets, Inc.","Lakeland","FL","US","Voluntary: Firm Initiated","E-Mail","Florida","F-1173-2013","Class I","Publix Peanut Butter Fudge Fix cakeScale ID Number * 002-95628-00000 *The last five digits of the scale ID number contain the unit price. For example $4.99 would have the last five digits ending 00499. ","Recalled products were distributed from November 11, 2012 through November 15, 2012.",,,"Maplehurst Deli-Bake South Inc. the cake supplier notified Publix Super market of a contamination with Listeria Monocytogenes on 11/15/2012.",11/15/2012,"11/15/2012",3/20/2013,"03/20/2013"
"Food",64493,"Completed","Publix Super Markets, Inc.","Lakeland","FL","US","Voluntary: Firm Initiated","E-Mail","Florida","F-1181-2013","Class I","Publix 7 inch Chocolate with Chocolate butter cream layer cakeScale ID Number * 002-95954-00000 *The last five digits of the scale ID number contain the unit price. For example $4.99 would have the last five digits ending 00499. ","Recalled products were distributed from November 11, 2012 through November 15, 2012.",,,"Maplehurst Deli-Bake South Inc. the cake supplier notified Publix Super market of a contamination with Listeria Monocytogenes on 11/15/2012.",11/15/2012,"11/15/2012",3/20/2013,"03/20/2013"
"Food",64493,"Completed","Publix Super Markets, Inc.","Lakeland","FL","US","Voluntary: Firm Initiated","E-Mail","Florida","F-1157-2013","Class I","Publix Chocolate Ganache Supreme cakeScale ID Number * 002-94085-00000 *The last five digits of the scale ID number contain the unit price. For example $4.99 would have the last five digits ending 00499. ","Recalled products were distributed from November 11, 2012 through November 15, 2012.",,,"Maplehurst Deli-Bake South Inc. the cake supplier notified Publix Super market of a contamination with Listeria Monocytogenes on 11/15/2012.",11/15/2012,"11/15/2012",3/20/2013,"03/20/2013"
"Food",64493,"Completed","Publix Super Markets, Inc.","Lakeland","FL","US","Voluntary: Firm Initiated","E-Mail","Florida","F-1184-2013","Class I","Publix 7 inch Black Forest cakeScale ID Number * 002-95970-00000 *The last five digits of the scale ID number contain the unit price. For example $4.99 would have the last five digits ending 00499. ","Recalled products were distributed from November 11, 2012 through November 15, 2012.",,,"Maplehurst Deli-Bake South Inc. the cake supplier notified Publix Super market of a contamination with Listeria Monocytogenes on 11/15/2012.",11/15/2012,"11/15/2012",3/20/2013,"03/20/2013"
"Food",64493,"Completed","Publix Super Markets, Inc.","Lakeland","FL","US","Voluntary: Firm Initiated","E-Mail","Florida","F-1188-2013","Class I","Publix 7 inchW/T Black Forest layer cakeScale ID Number * 002-95334-00000 *The last five digits of the scale ID number contain the unit price. For example $4.99 would have the last five digits ending 00499. ","Recalled products were distributed from November 11, 2012 through November 15, 2012.",,,"Maplehurst Deli-Bake South Inc. the cake supplier notified Publix Super market of a contamination with Listeria Monocytogenes on 11/15/2012.",11/15/2012,"11/15/2012",3/20/2013,"03/20/2013"
"Food",64493,"Completed","Publix Super Markets, Inc.","Lakeland","FL","US","Voluntary: Firm Initiated","E-Mail","Florida","F-1163-2013","Class I","Publix 7 inch Whipped Topping Choc Dec cakeScale ID Number * 002-94396-00000 *The last five digits of the scale ID number contain the unit price. For example $4.99 would have the last five digits ending 00499. ","Recalled products were distributed from November 11, 2012 through November 15, 2012.",,,"Maplehurst Deli-Bake South Inc. the cake supplier notified Publix Super market of a contamination with Listeria Monocytogenes on 11/15/2012.",11/15/2012,"11/15/2012",3/20/2013,"03/20/2013"
"Food",64493,"Completed","Publix Super Markets, Inc.","Lakeland","FL","US","Voluntary: Firm Initiated","E-Mail","Florida","F-1150-2013","Class I","Publix 7 inch Dec. Fudge iced w/filling cakeScale ID Number * 002-19748-00000 *The last five digits of the scale ID number contain the unit price. For example $4.99 would have the last five digits ending 00499. ","Recalled products were distributed from November 11, 2012 through November 15, 2012.",,,"Maplehurst Deli-Bake South Inc. the cake supplier notified Publix Super market of a contamination with Listeria Monocytogenes on 11/15/2012.",11/15/2012,"11/15/2012",3/20/2013,"03/20/2013"
"Food",64493,"Completed","Publix Super Markets, Inc.","Lakeland","FL","US","Voluntary: Firm Initiated","E-Mail","Florida","F-1177-2013","Class I","Publix 7 inch Chocolate with Fudge layer cakeScale ID Number * 002-95663-00000 *The last five digits of the scale ID number contain the unit price. For example $4.99 would have the last five digits ending 00499. ","Recalled products were distributed from November 11, 2012 through November 15, 2012.",,,"Maplehurst Deli-Bake South Inc. the cake supplier notified Publix Super market of a contamination with Listeria Monocytogenes on 11/15/2012.",11/15/2012,"11/15/2012",3/20/2013,"03/20/2013"
"Food",64493,"Completed","Publix Super Markets, Inc.","Lakeland","FL","US","Voluntary: Firm Initiated","E-Mail","Florida","F-1170-2013","Class I","Publix 7inch Chocolate Shadow cakeScale ID Number * 002-95323-00000 *The last five digits of the scale ID number contain the unit price. For example $4.99 would have the last five digits ending 00499. "," Recalled products were distributed from November 11, 2012 through November 15, 2012.",,,"Maplehurst Deli-Bake South Inc. the cake supplier notified Publix Super market of a contamination with Listeria Monocytogenes on 11/15/2012.",11/15/2012,"11/15/2012",3/20/2013,"03/20/2013"
"Food",64493,"Completed","Publix Super Markets, Inc.","Lakeland","FL","US","Voluntary: Firm Initiated","E-Mail","Florida","F-1145-2013","Class I","Publix 7 inch Chocolate Cookies n Cream CakeScale ID Number * 002-13584-00000 *The last five digits of the scale ID number contain the unit price. For example $4.99 would have the last five digits ending 00499. ","Recalled products were distributed from November 11, 2012 through November 15, 2012.",,"unknown","Maplehurst Deli-Bake South Inc. the cake supplier notified Publix Super market of a contamination with Listeria Monocytogenes on 11/15/2012.",11/15/2012,"11/15/2012",3/20/2013,"03/20/2013"
"Food",64493,"Completed","Publix Super Markets, Inc.","Lakeland","FL","US","Voluntary: Firm Initiated","E-Mail","Florida","F-1172-2013","Class I","Publix 7 inch German Chocolate Layer cakeScale ID Number * 002-95353-00000 *The last five digits of the scale ID number contain the unit price. For example $4.99 would have the last five digits ending 00499. ","Recalled products were distributed from November 11, 2012 through November 15, 2012.",,,"Maplehurst Deli-Bake South Inc. the cake supplier notified Publix Super market of a contamination with Listeria Monocytogenes on 11/15/2012.",11/15/2012,"11/15/2012",3/20/2013,"03/20/2013"
"Food",64493,"Completed","Publix Super Markets, Inc.","Lakeland","FL","US","Voluntary: Firm Initiated","E-Mail","Florida","F-1180-2013","Class I","Publix Chocolate with Cheesecake torte 6'' wholeScale ID Number * 002-95770-00000 *The last five digits of the scale ID number contain the unit price. For example $4.99 would have the last five digits ending 00499. ","Recalled products were distributed from November 11, 2012 through November 15, 2012.",,,"Maplehurst Deli-Bake South Inc. the cake supplier notified Publix Super market of a contamination with Listeria Monocytogenes on 11/15/2012.",11/15/2012,"11/15/2012",3/20/2013,"03/20/2013"
"Food",64493,"Completed","Publix Super Markets, Inc.","Lakeland","FL","US","Voluntary: Firm Initiated","E-Mail","Florida","F-1167-2013","Class I","Publix 7inch Ice Cream 1/2 & 1/2 DEC cakeScale ID Number * 002-94490-00000 *The last five digits of the scale ID number contain the unit price. For example $4.99 would have the last five digits ending 00499. ","Recalled products were distributed from November 11, 2012 through November 15, 2012.",,,"Maplehurst Deli-Bake South Inc. the cake supplier notified Publix Super market of a contamination with Listeria Monocytogenes on 11/15/2012.",11/15/2012,"11/15/2012",3/20/2013,"03/20/2013"
"Devices",64494,"Ongoing","Becton Dickinson & Company","Franklin Lakes","NJ","US","Voluntary: Firm Initiated","Letter","Nationwide Distribution including Arizona, California, Colorado, Georgia, Florida, Illinois, Iowa, Kentucky, Louisiana, Maryland, Massachussets, Michigan, Minnesota, Missouri, New Jersey, New Mexico, New York, North Carolina, Ohio, Oregon, Pennsylvania, Tennessee, Texas, Utah, Virginia, Washington DC, Washington, West Virginia, and Wisconsin.","Z-1056-2013","Class III","BD Vacutainer C&S Transfer Straw Kit C&S Preservative Plus Urine Tube. 4.0 ml, 13 X 75 mm STERILE REF 364953. Becton Dickinson & Company, Franklin Lakes, NJ USA, The kit consists of a transfer straw and urinalysis tube intended for UA chemistry urine testing. ","Catalog #3694991 appears as Catalog #364953 (Lot #1335484)",".","236,400 units","The BD Vacutainer Urinalysis Transfer Straw Kit #364991, Lot 1335484 has preprinted polybags which are incorrectly labeled as Catalog #364953. BD advises any Customer who purchased this Kit that the Tube in this Kit is not a C&S tube. If a Customer relies solely on the polybag labeling and uses the Tube inside the Kit for the purpose of collecting urine for culture and sensitivity, it is possible they would obtain an erroneous result since the Urinalysis Tube contained in the Kit does not contain any preservatives. ",2/14/2013,"02/14/2013",4/10/2013,"04/10/2013"
"Food",64496,"Ongoing","Blue Planet Foods, Inc.","Collegedale","TN","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Nationwide, Costa Rica, Trinidad, and Bermuda","F-1201-2013","Class II","Heartland, AMERICA'S ORIGINAL, Harvest Spice Granola Cereal, NET WT 14 OZ. (397g), UPC 024300090394","Best if used by dates: 20130326 (March 26, 2013) - 20130910 (September 10, 2013)",".","5425 cases of 6","Blue Planet products that contain the two recalled Dakota Specialty Milling ingredients; distribution of recalled bulk, wholesale, and cereal items.",2/19/2013,"02/19/2013",3/27/2013,"03/27/2013"
"Food",64496,"Ongoing","Blue Planet Foods, Inc.","Collegedale","TN","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Nationwide, Costa Rica, Trinidad, and Bermuda","F-1203-2013","Class II","Trio shipper which includes two of the recalled products: Heartland, AMERICA'S ORIGINAL, Harvest Spice Granola Cereal, NET WT 14 OZ. (397g), UPC 024300090394 and Heartland, AMERICA'S ORIGINAL, Fruit & Nut Harvest Granola Cereal, NET WT 14 OZ. (397g), UPC 024300090387","Best if used by dates: UPC 024300090394: 20130326 (March 26, 2013) - 20130910 (September 10, 2013) and UPC 0240300090387: 20130325 (March 25, 2013) - 20130910 (September 10, 2013) ",".","60 cases (720 units total)","Blue Planet products that contain the two recalled Dakota Specialty Milling ingredients; distribution of recalled bulk, wholesale, and cereal items.",2/19/2013,"02/19/2013",3/27/2013,"03/27/2013"
"Food",64496,"Ongoing","Blue Planet Foods, Inc.","Collegedale","TN","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Nationwide, Costa Rica, Trinidad, and Bermuda","F-1202-2013","Class II","Heartland, AMERICA'S ORIGINAL, Fruit & Nut Harvest Granola Cereal, NET WT 14 OZ. (397g), UPC 024300090387","Best if used by dates: 20130325 (March 25, 2013) - 20130910 (September 10, 2013)",".","9573 cases of 6 units","Blue Planet products that contain the two recalled Dakota Specialty Milling ingredients; distribution of recalled bulk, wholesale, and cereal items.",2/19/2013,"02/19/2013",3/27/2013,"03/27/2013"
"Food",64496,"Ongoing","Blue Planet Foods, Inc.","Collegedale","TN","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Nationwide, Costa Rica, Trinidad, and Bermuda","F-1205-2013","Class II","#38605020 ORTH TRANSMART(TM) PRE-BAKED CRISP TOPPING, NET WEIGHT 30 LBS. (13.6 kg)","codes: 20130706 07116051, 20130707 07126051, 20130801 08056052, 20130801 08056053, 20130801 08066051, 20130802 08066052, 20130810 08146053, 20130811 08166051, 20130812 08176051, 20130815 08196051, 20130830 09036052, 20130831 09046053, 20130901 09066051, 20130930 10046052, 20130930 10046053, 20130930 10056051, 20131003 10076052, 20131012 10166052, 20131012 10166052, 20131013 10176052, 20131014 10186052, 20131103 11086051, 20131109 11136052, 20131109 11146051, 20131208 12136051, 20131209 12136052, and 20140109 01136052 ",".","5992 cases of 12 units","Blue Planet products that contain the two recalled Dakota Specialty Milling ingredients; distribution of recalled bulk, wholesale, and cereal items.",2/19/2013,"02/19/2013",3/27/2013,"03/27/2013"
"Food",64496,"Ongoing","Blue Planet Foods, Inc.","Collegedale","TN","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Nationwide, Costa Rica, Trinidad, and Bermuda","F-1207-2013","Class II","Blue Planet, 10311 9 Grain Granola, NET WEIGHT 900 lbs (bulk product)","codes: 20121127 07306021, 20130212 10156021, 20130219 10226021, 20130313 11126023, 20130402 12036021, 20130403 12036022, 20130416 12166022, 20130426 12266022, 20130507 01066023, 20130515 01156021, 20130522 01216022, 20130528 01286021, 20130529 01286022, 20130110 10226021 ",".","304,398 lbs","Blue Planet products that contain the two recalled Dakota Specialty Milling ingredients; distribution of recalled bulk, wholesale, and cereal items.",2/19/2013,"02/19/2013",3/27/2013,"03/27/2013"
"Food",64496,"Ongoing","Blue Planet Foods, Inc.","Collegedale","TN","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Nationwide, Costa Rica, Trinidad, and Bermuda","F-1206-2013","Class II","10310 CRANBERRY ALMOND GRANOLA, 4/48 OZ.","codes: 20130707 10106071, 20130720 10236071, 20131012 01146072, 20131012 01146072",".","19,160 lbs","Blue Planet products that contain the two recalled Dakota Specialty Milling ingredients; distribution of recalled bulk, wholesale, and cereal items.",2/19/2013,"02/19/2013",3/27/2013,"03/27/2013"
"Food",64496,"Ongoing","Blue Planet Foods, Inc.","Collegedale","TN","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Nationwide, Costa Rica, Trinidad, and Bermuda","F-1204-2013","Class II","Hannaford Autumn Spice Granola, UPC 041268186327, NET WT. 14 OZ (397g) ","codes: 20130806 11096071 and 20130813 11156072",".","1292 cases of 12","Blue Planet products that contain the two recalled Dakota Specialty Milling ingredients; distribution of recalled bulk, wholesale, and cereal items.",2/19/2013,"02/19/2013",3/27/2013,"03/27/2013"
"Devices",64497,"Ongoing","Medtronic Neuromodulation","Minneapolis","MN","US","Voluntary: Firm Initiated","Letter","Nationwide Distribution including Puerto Rico and all States in continental USA except ID, MT, and NH.","Z-1031-2013","Class II","Medtronic Prostiva RF Therapy Generator. The Prostiva RF system is indicated for the treatment of symptoms due to urinary outflow obstruction secondary to benign prostatic hyperplasia (BPH) in men over the age of 50 with prostate sizes between 20 and 50 cm3.","all Model 8930 radio frequency (RF) generators are affected",".","848 (696 US, 152 OUS)","Medtronic has found through device testing that if the optional footswitch is not connected to the Model 8930 RF generator during use, an electrostatic discharge (i.e. static electricity) to the footswitch connector port may toggle the RF output on or off. If this were to occur, it could result in unintentionally starting or stopping the lesion process, depending on the current status of the equipment. The status messages on the display screen and associated audible alarms operate as intended, and would notify the clinician of any change in status. ",2/27/2013,"02/27/2013",4/10/2013,"04/10/2013"
"Food",64498,"Ongoing","Whole Foods Market","Austin","TX","US","Voluntary: Firm Initiated","E-Mail","AL, DC, GA, MD, NC, NJ, PA, SC, TN, and VA.","F-1144-2013","Class II","365 Organic Orzo, 16oz, 20 carton/case","UPC Code: 0 99482 43112 9; Lot Code: Lot 142251 ",,"56 cases (1120 cartons)","This product (one specific lot code) was being held at the manufacturers' request in distribution centers upon receiving. The vendor had an initial positive result for egg protein in one of their regularly scheduled tests, but it occurred after the product had shipped. The manufacturer tested again when they received a second positive result. At this time the manufacturer authorized Whole Foods Market and distribution centers to destroy the product on hand. Whole Foods Market learned from the distribution centers that two distribution centers had released the product by mistake, sending it from their York, Pa. and Atlanta, Ga. Distribution Centers to Whole Foods Market stores on Sunday November 18th,2012.",11/20/2012,"11/20/2012",3/20/2013,"03/20/2013"
"Devices",64499,"Completed","Nipro Diagnostics, Inc.","Ft Lauderdale","FL","US","Voluntary: Firm Initiated","Letter","Nationwide Distribution only in NY.","Z-1140-2013","Class II","Duane Reade TRUEtrack monitor kit, UPC# 6 39194 01679 7 Part # A4006-81 The TRUEtrack Blood Glucose System is intended for the quantitative determination of glucose in human whole blood taken from finger or forearm. The System is intended to be used to assist the patient and healthcare professional in the management of diabetes.","Finished Good (FG) Kit Lot# KL01009-3TI, TRUEtrack Test Strip Lot# RL3435; FG Kit Lot# KL01009-12TI, TRUEtrack Test Strip Lot# RL3435; FG Kit Lot# KL01233-4TI, TRUEtrack Test Strip Lot# RL3476; FG Kit Lot# KM0548TI, TRUEtrack Test Strip Lot# RM3547; FG Kit Lot# KM0645TI, TRUEtrack Test Strip Lot# RM3562; FG Lot# KM0692TI, TRUEtrack Test Strip Lot# RM3562.",".","1,627 Kits","Meter kit outer boxes containing 10 ct. test strips state incorrect storage temperature range.",2/25/2013,"02/25/2013",4/24/2013,"04/24/2013"
"Veterinary",64500,"Completed","Sogeval Laboratories, Inc.","Irving","TX","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","AL, AZ, CA, CO, FL, GA, IA, ID, IL, IN, KS, KY, LA, MI, MN, MS, NV, NY, OH, OK, OR, PA, TX, VA, WA, and WI","V-139-2013","Class III","Sogeval Oxiderm +PS Shampoo (Benzoyl Peroxide 3%, Sulfur 2%, Salicylic Acid 2%, PhytoSphingosine 0.05%) Antiseborrheic and Antiseptic Shampoo in a Moisturizing and Soap-Free Cleaning Base 16oz. - For topical use in dogs, cats and horses.","Lot # 10690BProduct code # FSOXYPS1016",".","1,882 bottles","Product contains approximately 12 ounces instead of 16 ounces.",3/18/2011,"03/18/2011",3/27/2013,"03/27/2013"
"Devices",64501,"Ongoing","Genetic Testing Institute,inc","Waukesha","WI","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution - USA (nationwide) and Internationally to Canada, China, Slovakia, and Spain.","Z-1022-2013","Class II","Gen-Probe LIFECODES PF4 Enhanced assay, Catalog No. X-HAT45 GTI PF4 Enhanced is designed as a solid phase enzyme-linked immunosorbent assay (ELISA). ","Kit Lot Number 3000389",,"386 kits (370 US, 16 OUS)","Lifecodes PF4 Enhanced assay, lot number 3000389, is being recalled because of observed inconsistent replicate values when testing the kit Positive Control and patient samples. The variation in reactivity can lead to invalid assays. If an invalid assay is obtained, those results should not be reported and the test should be re-run. An invalid assay would not result in significant harm to a patient. However, some kits from this lot may produce false negative results. A false negative result could contribute to a delay in diagnosis and initiation of alternative therapies, and may increase the risk of complications. ",2/4/2013,"02/04/2013",4/3/2013,"04/03/2013"
"Food",64502,"Ongoing","See's Candies Inc.","South San Francisco","CA","US","Voluntary: Firm Initiated","Press Release","See Candies stores in CA, AZ, NM, MO, OK, NV, UT, TX.","F-1061-2013","Class I","See's Candies, Divinity with Walnuts;Net Wt. 1.7 oz, (48 gr). See's Candies, South San Francisco, CA.","L.A.D. 102/13",,"2048 units","One code of 1.7 oz Divinity Easter Eggs with Walnuts may actually contain Peanut Butter Eggs.",2/28/2013,"02/28/2013",3/20/2013,"03/20/2013"
"Food",64503,"Ongoing","Food For Life Baking Company Inc.","Corona","CA","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","US states and Canada.","F-1143-2013","Class II","Ezekiel 4:9 Sprouted Grain Cereal- Cinnamon Raison, 16 oz. Packaging label reads in part:'' Food FOR Life***EZEKIEL 4:9 SPROUTED WHOLE GRAIN CEREAL Cinnamon Raison***NET WT. 16 OZ(454g)***MANUFACTURED BY: FOOD FOR LIFE BAKING COMPANY, INC. P.O. BOX 1434 CORONA, CA 92878-1434***''.","UPC 07347200257 2 LOT numbers: M3232, M3313, M3328, M3425, M3512, M3527, M3537, N0045, N0132 Best by dates: JAN. 21, 2014 JAN. 30, 2014 FEB. 6, 2014 FEB. 13, 2014 FEB. 23, 2014 FEB. 25, 2014 FEB. 26,2014 MAR. 9, 2014 MAR. 15, 2014 ",,"7337 cases","The firm is recalling Ezekiel 4:9 Sprouted Grain Cereal because the product may be mislabeled and may contain an undeclared allergen - almond.",3/1/2013,"03/01/2013",3/20/2013,"03/20/2013"
"Food",64503,"Ongoing","Food For Life Baking Company Inc.","Corona","CA","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","US states and Canada.","F-1141-2013","Class II","Ezekiel 4:9 Sprouted Grain Cereal- Original, 16 oz. Packaging label reads in part:''***Food FOR Life*** Ezekiel 4:9 SPROUTED WHOLE GRAIN CEREAL ORIGINAL NET WT. 16 OZ (454g)***MANUFACTURED BY: FOOD FOR LIFE BAKING COMPANY, INC. P.O. BOX 1434 CORONA, CA 92878-1434***''.","UPC 07347200255 1LOT numbers: M3232, M3313, M3512, M3565 Best by dates: NOV. 21, 2013 NOV. 30, 2013 DEC. 19, 2013 DEC. 27, 2013 ",,"1787 cases","The firm is recalling Ezekiel 4:9 Sprouted Grain Cereal because the product may be mislabeled and may contain an undeclared allergen - almond.",3/1/2013,"03/01/2013",3/20/2013,"03/20/2013"
"Food",64503,"Ongoing","Food For Life Baking Company Inc.","Corona","CA","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","US states and Canada.","F-1142-2013","Class II","Ezekiel 4:9 Sprouted Grain Cereal- Golden Flax, 16 oz. Packaging label reads in part:'' Food FOR Life***EZEKIEL 4:9 SPROUTED WHOLE GRAIN CEREAL GOLDEN FLAX***NET WT. 16 OZ(454g)***MANUFACTURED BY: FOOD FOR LIFE BAKING COMPANY, INC. P.O. BOX 1434 CORONA, CA 92878-1434***''.","UPC 07347200256 8LOT numbers: M3253, M3309, M3414, M3439, M3523, N0068, N0165 Best by dates: NOV. 24, 2013 DEC. 5, 2013 DEC. 11, 2013 DEC. 18, 2013 DEC. 21, 2013 JAN. 14, 2014 JAN. 15, 2014 ",,"6245 cases","The firm is recalling Ezekiel 4:9 Sprouted Grain Cereal because the product may be mislabeled and may contain an undeclared allergen - almond.",3/1/2013,"03/01/2013",3/20/2013,"03/20/2013"
"Devices",64504,"Ongoing","B. Braun Medical, Inc.","Allentown","PA","US","Voluntary: Firm Initiated","Letter","Nationwide Distribution including the states of AZ, CA, DE, FL, GA, HI, IA, ID, IL, KS, KY, LA, MN, MO, NJ, NM, NY, OH, OR, PA, SC, SD, TN, TX, UT, WA and WV.","Z-1183-2013","Class II","Diacap(R) Ultra Dialysis Fluid Filter, Catalog Number 7107367. Intended to filter bacteria and endotoxins from dialysis fluid.","Lot numbers 302950410, 309910111, 313050411, 314300511, 316040711, 316450711, 305880812, 306301012, and 306311012.",,"1580","There is the potential of the residual moisture of the Diacap Ultra membrane being reduced over time, which results in the reduction of the membrane permeability (ultrafiltration coefficient).",3/1/2013,"03/01/2013",5/8/2013,"05/08/2013"
"Devices",64505,"Ongoing","Stelkast Co","Mcmurray","PA","US","Voluntary: Firm Initiated","Telephone","Nationwide Distribution including the states of NV, OK and PA.","Z-1066-2013","Class II","Stelkast Cross-over Acetabular Shell and Liner Hip System, Part Numbers SC3458-52, SC3474-52, SC3459-52, and SC3460-52. Intended for use in reconstruction of the articulating surface of the acetabular portion of the hip. ","Part Numbers SC3458-52, lot number 28820-112612; SC3474-52, lot number 28822-101812; SC3459-52, lot number 28823-101812; and SC3460-52, lot number 28821-000.",,"254","Firm was made aware of incidents relating to the difficulty of properly engaging and securing the Cross-Over 36mm liner into the Cross-Over shell. ",1/24/2013,"01/24/2013",4/17/2013,"04/17/2013"
"Drugs",64506,"Ongoing","Actavis Elizabeth LLC","Elizabeth","NJ","US","Voluntary: Firm Initiated","Letter","Nationwide","D-190-2013","Class III","Dextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphetamine Sulfate, Amphetamine Sulfate Extended-Release Capsules, 15 mg, Rx Only, C II, 100 capsules per bottle, MFG. By Actavis Elizabeth LLC. 200 Elmora Ave, Elizabeth, NJ, 07207, USA, NDC 0228-3063-11. ","Lot #: 50077231",,"9,264 Bottles","Failed Dissolution Specification: This product recall is due to the product lot # 50077231 exceeding dissolution specifications. All other test specifications were met. ",2/13/2013,"02/13/2013",3/13/2013,"03/13/2013"
"Devices",64508,"Completed","Sirtex Medical Limited","North Ryde, New South Wales",,"AU","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Nationwide Distribution-USA (nationwide) including DC and the states of AZ, CA, CT, GA, ID, IL,KY, LA, MD, ME, MO, MT, NJ, NV, WA, and WV.","Z-1162-2013","Class III","Sirtex SIR-yttrium 90 microspheres (Radionuclide); SIR-Y001. Indicated for the treatment of unresectable metastatic liver tumors. "," Batch HB024V02 to HB024V14; Batch HB025V02 to HB024V10 ",".","21 doses","Incorrect expiration date",2/27/2013,"02/27/2013",5/1/2013,"05/01/2013"
"Devices",64509,"Ongoing","Allen Medical Systems, Inc.","Acton","MA","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution- USA including the states of TX, NV, KY, GA, OH, PA, NY, AL, WA, IL and the countries of New Zealand and Japan.","Z-0959-2013","Class II","Allen Traction Boot - Modular, OT 1000 Traction Device Boot Assembly, Fracture Table Orthopedic Leg Holders, non-invasive medical devices designed to attach to orthopedic fracture tables to aid clinical staff in applying traction to the leg of a patient during surgical procedures.","A260264, A253312, A260989, A260262, 418292, A260991, A260998, A253313, A260993, A260265, 418293, A253309, A260995, A253310, A260992, A253311, 418294, A253323, A260261, A253321, A260994, 418291, 418295, A253322",".","24 devices","Some units may have been assembled incorrectly which could result in the boot breaking free from the mounting base and allowing the patient's leg to fall. ",2/28/2013,"02/28/2013",3/27/2013,"03/27/2013"
"Devices",64510,"Ongoing","Cooper Surgical, Inc.","Trumbull","CT","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution -- USA, including the states of NE, MA, FL, TN, CA, ME, SC, CA, NH, OK, TX, NM, MO, NY, PA, and AZ, and countries of Germany, Italy, and Canada.","Z-1018-2013","Class II","Omniflex Diaphragm - Size 65 (Milex Wide Seal Silicone Vaginal Diaphragm) Model MXWF65 Intended for use in contraception.","Lot 113367",,"80 individual diaphragms","Incorrect size was printed on the outer product packaging. ",2/26/2013,"02/26/2013",4/3/2013,"04/03/2013"
"Devices",64511,"Ongoing","Vascular Solutions, Inc.","Maple Grove","MN","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution -- USA, including the states of AL, AZ, AR, CA, CO, CT, DE, DC, FL, GA, HI, IL IN, IA, KS, KY, LA, MD, MA, MI, MN, MS, MO, NE, NV, NJ, NY, NC, ND, OH, OK, OR, PA, SC, SD, TN, TX, UT , VT, VA, WA, WV, and WI, and countries of GREECE, DENMARK, AUSTRIA, UNITED KINGDOM, SWITZERLAND, IRELAND, INDIA, TURKEY, POLAND, HUNGARY, ITALY, EGYPT, KOREA, PORTUGAL HONG KONG, GERMANY, SPAIN, MEXICO, SWEDEN, NORWAY SLOVENIA, NETHERLANDS, and BELGIUM.","Z-0955-2013","Class I","Guardian II and Guardian II NC Hemostasis Valve, Model #'s: FH101, FH101-T, FH101-25, FH101-50, 8210, 8211, FH102, FH102-T, FH102-25, FH102-50, 8215, 8216, 8241, 8242, 8244, 8272 and 8274. Vascular Solutions Zerusa Limited 209 Business Innovation Centre, NUI Galway, Newcastle Road, Galway, Ireland. Intended to maintain hemostasis during the use of diagnostic/interventional devices during diagnostic/interventional procedures. ","Lot Number 29132 27295 27403 27660 27660 28050 28247 28247 28247 28247 28820 29133 29836 29836 30126 30579 30582 27658 28246 28246 29132 29132 29132 27658 27658 27658 28041 28041 28041 28048 28048 28245 28245 28245 28818 28818 28818 29131 30238 30580 27659 28049 29132 27294 27402 30582 31020 562784 27401 27658 27658 28041 28041 28245 28818 29131 29131 29453 29835 30238 27334 27397 27646 27646 27651 27779 28001 28006 28044 28051 28427 28817 29016 29016 29016 29137 29455 29455 29837 29837 30928 30930 30932 29454 28049 28246 28819 30581 27295 27403 27401 27658 28041 28245 28245 28245 28818 29453 29453 30580 28048 28001 28745 29016 29839 27403 31020 30579 27401 29131 30238 28048 28048 28050 30579 27295 27295 27295 27295 27295 27295 27295 27295 27403 27403 27403 27403 27660 27660 27660 27660 27660 28043 28043 28043 28043 28247 28247 28247 28247 28247 28247 28247 28247 28247 28820 28820 28820 28820 29133 29133 29133 29133 29836 29836 29836 29836 30126 30126 30126 30126 30579 30579 30579 30579 30579 30579 30579 30582 30582 30582 27295 29133 29131 27403 27660 28043 28050 28247 29133 30126 30579 28820 29133 29836 30126 30579 27401 28041 28048 28818 29453 29835 30580 562005 27658 28041 28048 28245 29131 29453 29835 30238 30580 28048 29453 29835 29835 29835 27401 27658 28041 28041 28048 28245 28818 29131 29453 29835 30238 30579 27401 27658 27658 28041 28041 28048 28048 28048 28245 28245 28245 28818 28818 29131 29453 29453 29835 29835 30238 30580 29131 28245 30579 30238 28048 30579 27295 27401 27658 28041 28245 28818 29453 29453 30580 27295 27401 28247 28247 28247 28820 28820 29133 29133 29133 29836 30126 30126 30579 30579 30579 30582 27658 28245 30126 29133 28048 28048 29133 30582 27660 27403 28820 27403 27403 27403 28043 28247 29133 27403 28050 28247 28247 27403 28043 28043 30126 27295 27660 28043 28247 28247 28820 29133 30579 27401 27658 28041 28041 28048 28048 28245 29131 29131 29132 29835 28001 29686 27215 27391 27656 28429 29456 27401 27658 27658 28041 28048 28245 29131 29131 29453 29835 29835 30580 27401 27658 2765",".","79,869","Vascular Solutions, Inc., is recalling certain lots of Guardian II and Guardian II NC Hemostasis Valves, due to the risk that air may be introduced into the device which may lead to an air embolism.",2/27/2013,"02/27/2013",3/27/2013,"03/27/2013"
"Devices",64512,"Ongoing","Molift Inc.","Tampa","FL","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","US Nationwide Distribution: CA, FL, GA, ID, IL, KY, MA, ME, MI, MN, NC, NH, NJ, NM, NV, NY, OH, OK, PA, TN, TX, VT, WA and Hawaii. Foreign Distribution:: Australia, Austria; Belgium, Denmark, Finland, France, Germany, Iceland, Israel, Italy, Japan, Netherlands, New Zealand, Norway, Spain, Sverige, Switzerland, United Kingdom.","Z-1342-2013","Class II","Molift Smart SWL150 kg Product Usage: To lift and transport a patient in the horizontal or other required position from one place to another. ","Art #: 0920001 batch 1-62 and 0920002 batch 1-77; Serial Number ranges 022228 to 094103 and 100015 to 12058.",".","7,555 units subject to review; US: 1,280 units - Foreign: 6,275 units","The Molift Smart (now known as the Molift Smart 150) is a foldable, mobile hoist with a safe working load (''SWL'') of 150 kg (approximately 330 lbs.) and is intended for lifting and transferring a disabled person. The hoist is made out of lightweight materials for ease of operation. It has castors and is battery-powered. The Molift Smart includes a leg spreading mechanism to give optimal functionality to the product. If not assembled correctly with the locking devices, failure of the hoist may result in collapsing. ",2/15/2013,"02/15/2013",5/29/2013,"05/29/2013"
"Devices",64512,"Ongoing","Molift Inc.","Tampa","FL","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","US Nationwide Distribution: CA, FL, GA, ID, IL, KY, MA, ME, MI, MN, NC, NH, NJ, NM, NV, NY, OH, OK, PA, TN, TX, VT, WA and Hawaii. Foreign Distribution:: Australia, Austria; Belgium, Denmark, Finland, France, Germany, Iceland, Israel, Italy, Japan, Netherlands, New Zealand, Norway, Spain, Sverige, Switzerland, United Kingdom.","Z-1343-2013","Class II","Molift Smart 150 Product Usage: To lift and transport a patient in the horizontal or other required position from one place to another. ","Art #: 0920008; Serial Number range 20941 to 27299.",".","Subject to recall 1,460 units; US: 175 units; Foreign: 1,285 units","The Molift Smart 150 (formerly ''Molift Smart'') is a foldable, mobile, battery-powered hoist for lifting and transfer of disabled persons, with a safe working load (''SWL'') of 150 kg (approximately 330 lbs.). The hoist includes a leg-spreading mechanism, equipped with a safety mechanism, to give optimal safety and functionality to the device.",2/15/2013,"02/15/2013",5/29/2013,"05/29/2013"
"Food",64513,"Terminated","Wynlife Healthcare, Inc.","San Diego","CA","US","Voluntary: Firm Initiated","Letter","Nationwide distribution.","F-1244-2013","Class II","All-In-One Probiotics, K12-BB12-LB3; Dietary Supplement; 30 Packets;Serving size 2 Tablets (1 Packet)l L141/1. Adults take 2 to 4 tablets daily; Children: take 1 to 2 tablets daily (or as directed by your healthcare practitioner. Chew slowly or allow to dissolve in mouth. Manufactured for Wynlife Healthcare, Inc., San Diego, CA 92130.","PN 141; Lot #'s: 100521 and 110099",".","456 boxes","Wynlife healthcare is recalling their All-In-One Probiotics and Vegi-Fiber Plus products due to DEHP contaminated clouding agents.",5/31/2011,"05/31/2011",3/27/2013,"03/27/2013"
"Food",64513,"Terminated","Wynlife Healthcare, Inc.","San Diego","CA","US","Voluntary: Firm Initiated","Letter","Nationwide distribution.","F-1243-2013","Class II","Vegi-Fiber Plus; O Trans Fat; only 15.4 Calories; Dietary Supplement; 60 Packets; Scientific formula for Natural Vitality; 15 Vegetable and Fruit Extracts; Newest Japanese Carbohydrate Blocker: Fibersol -2; Each Packet Contains 3.5g of Water-Soluble Dietary Fiber. Manufactured for Wynlife Healthcare, Inc., San Diego, CA 92130.","PN 135; Lot #'s: 090336 and 100340",".","210 boxes","Wynlife healthcare is recalling their All-In-One Probiotics and Vegi-Fiber Plus products due to DEHP contaminated clouding agents.",5/31/2011,"05/31/2011",3/27/2013,"03/27/2013"
"Biologics",64514,"Terminated","Community Blood Centers of South Florida, Inc.","Hialeah","FL","US","Voluntary: Firm Initiated","Letter","Switzerland; Florida; New York","B-1401-13","Class III","Blood and Blood Products for Reprocessing","W036812601445; 2032178; ",,"2","Blood products, collected from a donor in whom donor suitability was not adequately determined, were distributed.",2/10/2013,"02/10/2013",6/26/2013,"06/26/2013"
"Biologics",64514,"Terminated","Community Blood Centers of South Florida, Inc.","Hialeah","FL","US","Voluntary: Firm Initiated","Letter","Switzerland; Florida; New York","B-1403-13","Class II","Red Blood Cells","W036812601445; 2032178; 1650021; 9587583; 9595817; 8867631; 8758959; 8715697; 8624662; ",,"9","Blood products, collected from a donor in whom donor suitability was not adequately determined, were distributed.",2/10/2013,"02/10/2013",6/26/2013,"06/26/2013"
"Biologics",64514,"Terminated","Community Blood Centers of South Florida, Inc.","Hialeah","FL","US","Voluntary: Firm Initiated","Letter","Switzerland; Florida; New York","B-1405-13","Class II","Platelets","1650021, 8867631, 8624662",,"3","Blood products, collected from a donor in whom donor suitability was not adequately determined, were distributed.",2/10/2013,"02/10/2013",6/26/2013,"06/26/2013"
"Biologics",64514,"Terminated","Community Blood Centers of South Florida, Inc.","Hialeah","FL","US","Voluntary: Firm Initiated","Letter","Switzerland; Florida; New York","B-1400-13","Class II","Platelets Pooled Leukocytes Reduced","W036812846949; ",,"1","Blood products, collected from a donor in whom donor suitability was not adequately determined, were distributed.",2/10/2013,"02/10/2013",6/26/2013,"06/26/2013"
"Biologics",64514,"Terminated","Community Blood Centers of South Florida, Inc.","Hialeah","FL","US","Voluntary: Firm Initiated","Letter","Switzerland; Florida; New York","B-1402-13","Class II","Fresh Frozen Plasma","1650021; 9587583; 8758959; ",,"3","Blood products, collected from a donor in whom donor suitability was not adequately determined, were distributed.",2/10/2013,"02/10/2013",6/26/2013,"06/26/2013"
"Biologics",64514,"Terminated","Community Blood Centers of South Florida, Inc.","Hialeah","FL","US","Voluntary: Firm Initiated","Letter","Switzerland; Florida; New York","B-1404-13","Class II","Cryoprecipitated AHF","8624662; ",,"1","Blood products, collected from a donor in whom donor suitability was not adequately determined, were distributed.",2/10/2013,"02/10/2013",6/26/2013,"06/26/2013"
"Biologics",64515,"Terminated","Community Blood Centers of Florida, Inc.","Miami","FL","US","Voluntary: Firm Initiated","Telephone","Florida","B-1406-13","Class II","Platelets","1614729; ",,"1","Blood products, collected from a donor for whom donor suitability was not adequately determined, were distributed.",2/12/2013,"02/12/2013",6/26/2013,"06/26/2013"
"Biologics",64515,"Terminated","Community Blood Centers of Florida, Inc.","Miami","FL","US","Voluntary: Firm Initiated","Telephone","Florida","B-1408-13","Class II","Fresh Frozen Plasma","1614729; W036812426040; ",,"2","Blood products, collected from a donor for whom donor suitability was not adequately determined, were distributed.",2/12/2013,"02/12/2013",6/26/2013,"06/26/2013"
"Biologics",64515,"Terminated","Community Blood Centers of Florida, Inc.","Miami","FL","US","Voluntary: Firm Initiated","Telephone","Florida","B-1407-13","Class II","Red Blood Cells","W036812426040; 1614729; ",,"2","Blood products, collected from a donor for whom donor suitability was not adequately determined, were distributed.",2/12/2013,"02/12/2013",6/26/2013,"06/26/2013"
"Biologics",64516,"Terminated","OneBlood / dba CBCF","Lauderhill","FL","US","Voluntary: Firm Initiated","Telephone","Florida","B-1352-13","Class II","Red Blood Cells Leukocytes Reduced","W036812599383; ",".","1","Blood products, collected from a donor for whom donor suitability was not adequately determined, were distributed.",2/18/2013,"02/18/2013",6/12/2013,"06/12/2013"
"Biologics",64516,"Terminated","OneBlood / dba CBCF","Lauderhill","FL","US","Voluntary: Firm Initiated","Telephone","Florida","B-1353-13","Class II","Red Blood Cells","W036812566971; ",".","1","Blood products, collected from a donor for whom donor suitability was not adequately determined, were distributed.",2/18/2013,"02/18/2013",6/12/2013,"06/12/2013"
"Biologics",64516,"Terminated","OneBlood / dba CBCF","Lauderhill","FL","US","Voluntary: Firm Initiated","Telephone","Florida","B-1355-13","Class II","Fresh Frozen Plasma","W036812566971; ",".","1","Blood products, collected from a donor for whom donor suitability was not adequately determined, were distributed.",2/18/2013,"02/18/2013",6/12/2013,"06/12/2013"
"Biologics",64516,"Terminated","OneBlood / dba CBCF","Lauderhill","FL","US","Voluntary: Firm Initiated","Telephone","Florida","B-1354-13","Class II","Platelets Pooled Leukocytes Reduced","W036812843768; ",".","1","Blood products, collected from a donor for whom donor suitability was not adequately determined, were distributed.",2/18/2013,"02/18/2013",6/12/2013,"06/12/2013"
"Biologics",64516,"Terminated","OneBlood / dba CBCF","Lauderhill","FL","US","Voluntary: Firm Initiated","Telephone","Florida","B-1351-13","Class III","Blood and Blood Products for Reprocessing","W036812599383; ",".","1","Blood products, collected from a donor for whom donor suitability was not adequately determined, were distributed.",2/18/2013,"02/18/2013",6/12/2013,"06/12/2013"
"Biologics",64517,"Terminated","LifeServe Blood Center","Des Moines","IA","US","Voluntary: Firm Initiated","Telephone","Nebraska","B-1356-13","Class II","Red Blood Cells (Apheresis) Leukocytes Reduced","W044113003135; ",".","1","Blood product, collected from a donor, whose suitability to donate was not adequately determined, was distributed.",2/14/2013,"02/14/2013",6/12/2013,"06/12/2013"
"Biologics",64518,"Terminated","LifeServe Blood Center","Des Moines","IA","US","Voluntary: Firm Initiated","E-Mail","Iowa; South Carolina","B-1357-13","Class II","Red Blood Cells (Apheresis) Leukocytes Reduced","W044112128378 Part 1; W044112128378 Part 2; ",".","2","Blood products, collected from a donor who received a tattoo within 12 months of donation, were distributed.",2/8/2013,"02/08/2013",6/12/2013,"06/12/2013"
"Biologics",64519,"Terminated","Antigen Laboratories Inc","Liberty","MO","US","Voluntary: Firm Initiated","Telephone","Nationwide","B-1364-13","Class III","Pine, Australian Allergenic Extract","P46050812A",,"1","Allergenic Extracts, reprocessed by an unapproved process, were distributed. ",2/22/2013,"02/22/2013",4/17/2013,"04/17/2013"
"Biologics",64520,"Terminated","Inova Health Care Services, Inova Blood Donor Services","Sterling","VA","US","Voluntary: Firm Initiated","Letter","New York; Indiana","B-1358-13","Class II","Red Blood Cells Leukocytes Reduced","W089811607217; ",".","1","Blood products, collected from a donor who was at risk for variant Creutzfeldt-Jakob disease (vCJD), were distributed.",1/28/2013,"01/28/2013",6/12/2013,"06/12/2013"
"Biologics",64520,"Terminated","Inova Health Care Services, Inova Blood Donor Services","Sterling","VA","US","Voluntary: Firm Initiated","Letter","New York; Indiana","B-1359-13","Class II","Blood and Blood Products for Reprocessing","W089811607217; ",".","1","Blood products, collected from a donor who was at risk for variant Creutzfeldt-Jakob disease (vCJD), were distributed.",1/28/2013,"01/28/2013",6/12/2013,"06/12/2013"
"Biologics",64521,"Terminated","Blood Systems, Inc. dba United Blood Services","Lubbock","TX","US","Voluntary: Firm Initiated","Telephone","Texas","B-1487-13","Class III","Red Blood Cells Leukocytes Reduced","W041513000604*, W041513000606W, W041513000609Q, W041513000612*, W041513000613Y, W0415130006015, W0415130006023, W041513000605Y, W041513000614W, W041513000615U",".","10 units","Blood products, collected from donors whose body temperatures were determined incorrectly, were distributed.",1/15/2013,"01/15/2013",6/19/2013,"06/19/2013"
"Biologics",64521,"Terminated","Blood Systems, Inc. dba United Blood Services","Lubbock","TX","US","Voluntary: Firm Initiated","Telephone","Texas","B-1486-13","Class III","Plasma Frozen","W041513000604*, W041513000605Y, W041513000613Y, W041513000615U",".","4 units","Blood products, collected from donors whose body temperatures were determined incorrectly, were distributed.",1/15/2013,"01/15/2013",6/19/2013,"06/19/2013"
"Biologics",64522,"Terminated","Community Blood Center Of Gtr KC","Kansas City","MO","US","Voluntary: Firm Initiated","FAX","Kansas","B-1489-13","Class II","Red Blood Cells Leukocytes Reduced","W045012008981",".","1 unit","Blood product, collected from a donor who traveled to an area considered endemic for malaria, was distributed.",1/9/2013,"01/09/2013",6/19/2013,"06/19/2013"
"Biologics",64523,"Completed","Blood Systems Inc ","Scottsdale","AZ","US","Voluntary: Firm Initiated","FAX","Arizona","B-1483-13","Class II","Red Blood Cells (Apheresis) Leukocytes Reduced","W041013005157E; W041013005157E",".","2 units","Blood Products, collected from an ineligible donor, were distributed. ",1/22/2013,"01/22/2013",6/12/2013,"06/12/2013"
"Biologics",64524,"Terminated","Blood Systems Inc ","Scottsdale","AZ","US","Voluntary: Firm Initiated","FAX","Arizona","B-1488-13","Class II","Platelets Pheresis Leukocytes Reduced","W041013009100L",".","1 unit","Blood product, with a low platelet concentration, was distributed.",1/17/2013,"01/17/2013",6/19/2013,"06/19/2013"
"Biologics",64525,"Terminated","American Red Cross Greater Alleghenies Region","Johnstown","PA","US","Voluntary: Firm Initiated","Other","California","B-1492-13","Class III","Recovered Plasma","27F08066",,"1 unit","Blood product, collected from a donor for whom donor suitability was not adequately determined, was distributed.",1/19/2013,"01/19/2013",6/26/2013,"06/26/2013"
"Biologics",64526,"Terminated","Florida's Blood Centers, Inc.","Orlando","FL","US","Voluntary: Firm Initiated","Telephone","Florida","B-1491-13","Class II","Plasma Frozen within 24 hours (FP24)","W038112319673",".","1 unit","Blood products, collected from a donor who deferred for receiving a piercing, were distributed.",1/15/2013,"01/15/2013",6/19/2013,"06/19/2013"
"Biologics",64526,"Terminated","Florida's Blood Centers, Inc.","Orlando","FL","US","Voluntary: Firm Initiated","Telephone","Florida","B-1490-13","Class II","Red Blood Cells Leukocytes Reduced","W038112319673",".","1 unit","Blood products, collected from a donor who deferred for receiving a piercing, were distributed.",1/15/2013,"01/15/2013",6/19/2013,"06/19/2013"
"Devices",64527,"Completed","Arrow International Inc","Reading","PA","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution -- USA, Belgium, Great Britain, Italy, Kazakhstan, Latvia, Russia, Slovenia, Turkey, and South Africa.","Z-1065-2013","Class II","Arrow International FiberOptix Intra-Aortic Balloon Catheter Kit (IAB) 8 Fr 40 cc;Product Number: IAB-05840-LWS. The IAB is utilized for intra-aortic balloon counter-pulsation therapy.","Lot Numbers:KF2073694 KF2083874 KF2083966 KF2094179 KF2073788 KF2083927 KF2084059",,"637 units","Potential to have an internal leak at the fill port of the stainless steel tip, which may necessitate removal and replacement ofthe catheter.",11/27/2012,"11/27/2012",4/17/2013,"04/17/2013"
"Devices",64527,"Completed","Arrow International Inc","Reading","PA","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution -- USA, Belgium, Great Britain, Italy, Kazakhstan, Latvia, Russia, Slovenia, Turkey, and South Africa.","Z-1064-2013","Class II","Arrow International FiberOptix Intra-Aortic Balloon Catheter Kit (IAB) 8 Fr 30 cc;Product Number: IAB-05830-LWS. The IAB is utilized for intra-aortic balloon counter-pulsation therapy.","Lot Numbers:KF2073734 KS2083999 KF2083869 KF2083921",,"188 units","Potential to have an internal leak at the fill port of the stainless steel tip, which may necessitate removal and replacement ofthe catheter.",11/27/2012,"11/27/2012",4/17/2013,"04/17/2013"
"Devices",64528,"Ongoing","Cooper Surgical, Inc.","Trumbull","CT","US","Voluntary: Firm Initiated","Letter","Nationwide Distribution including Puerto Rico","Z-1053-2013","Class II","LEEP REDIKIT Product No. 6060 In a Loop Electrosurgical Excision Procedure, a thin, low-voltage electrified wire loop is used to cut out abnormal cervical tissue. The cartridges of Polocaine and Xylocaine with Epinephrine contained in the LEEP RediKit are local anaesthetic which the physician may choose from during the procedure. ","Lot 120716, exp 8-31-13; Lot 116657 exp. 6-30-13; Lot 116658 exp. 5-31-13; Lot 116659 exp. 7-31-13",".","4395 kits","LEEP RediKit Products (for use in Loop Electrosurgical Excision Procedures) have Xylocaine (Lidocaine) HCL (2%) listed on the tray lid label but this is not included in the contents of the kit, which contained Polocaine (Mepivacaine) HCL (3%) instead (which was not listed on the tray label). ",2/26/2013,"02/26/2013",4/10/2013,"04/10/2013"
"Devices",64529,"Ongoing"," AGFA Corp.","Greenville","SC","US","Voluntary: Firm Initiated","Telephone","USA Nationwide Distribution including the states of: AL, CA, FL, IN, MN, NE, NV, OH, SC and UT.","Z-0970-2013","Class II","CR MD1.0 General Set, x-ray imager image plate. Product Usage: Usage: The product is an image plate, contained in an X-Ray cassette, and used to capture images from X-Ray exposures. The cassette with the image plate, once exposed is inserted int he Agfa Digitizer CR 10-X where the image plate is taken out of the cassette and then scanned so that the scanned image can be displayed for viewing. ","Batch No. A2KQMW",".","17","The cassettes were shipped with the wrong IP (image plate) size bar code.",2/7/2013,"02/07/2013",3/27/2013,"03/27/2013"
"Devices",64530,"Ongoing","Terumo Cardiovascular Systems Corporation","Ann Arbor","MI","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution including the countries of UAE (United Arab Emirates) HONG KONG and THAILAND. Not distributed in USA","Z-1569-2013","Class II","Sarns '' TCM II Temperature Control Module The Sarns'' TCM II Temperature Control Module is a source of temperature-controlled water for blood heat exchangers used in an extracorporeal circuit and is indicated for controlling and monitoring patient temperature","Catalog Number 4416 and Serial Numbers: 4656, 4657, 4658,4659, 4661, 4662, and 4663.",,"7 units","Internal testing found certain Sarns'' TCM II systems were released with incorrectly assembled heatsink assemblies which could cause the units to fail.",5/30/2013,"05/30/2013",7/3/2013,"07/03/2013"
"Devices",64531,"Ongoing","Cooper Surgical, Inc.","Trumbull","CT","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution - USA (nationwide) and internationally to Australia, Canada, Colombia, Demarkt, France, Holland, New ZeaJand, andThailand.","Z-1008-2013","Class III","Cooper Surgical Incontinence Dish Folding Pessary #0, 55mm. MilexPart Number: MXPCOND00 A pessary is a medical device that is inserted into the vagina to function as a supportive structure of the uterus and/or bladder and rectum. "," Lot Number:114287",,"31 units","Pessary mislabeled outer package may not reflect the size of the product contained in the package",2/26/2013,"02/26/2013",4/3/2013,"04/03/2013"
"Devices",64531,"Ongoing","Cooper Surgical, Inc.","Trumbull","CT","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution - USA (nationwide) and internationally to Australia, Canada, Colombia, Demarkt, France, Holland, New ZeaJand, andThailand.","Z-1007-2013","Class III","Cooper Surgical Incontinence Dish Folding Pessary #0, 55mm. MilexPart Number: MXKPCOND00 A pessary is a medical device that is inserted into the vagina to function as a supportive structure of the uterus and/or bladder and rectum. "," Lot Number:114288",,"36 units","Pessary mislabeled outer package may not reflect the size of the product contained in the package",2/26/2013,"02/26/2013",4/3/2013,"04/03/2013"
"Devices",64531,"Ongoing","Cooper Surgical, Inc.","Trumbull","CT","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution - USA (nationwide) and internationally to Australia, Canada, Colombia, Demarkt, France, Holland, New ZeaJand, andThailand.","Z-1012-2013","Class III","Cooper Surgical Cube Pessary w/Drainage Holes #0''1'', 25mm. MilexPart Number: MXKPECH00 A pessary is a medical device that is inserted into the vagina to function as a supportive structure of the uterus and/or bladder and rectum. "," Lot Number:121784",,"20 units","Pessary mislabeled outer package may not reflect the size of the product contained in the package",2/26/2013,"02/26/2013",4/3/2013,"04/03/2013"
"Devices",64531,"Ongoing","Cooper Surgical, Inc.","Trumbull","CT","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution - USA (nationwide) and internationally to Australia, Canada, Colombia, Demarkt, France, Holland, New ZeaJand, andThailand.","Z-1010-2013","Class III","Cooper Surgical Gellhorn Flexible Pessary 3'', 76mm. MilexPart Number: MXPGE3- A pessary is a medical device that is inserted into the vagina to function as a supportive structure of the uterus and/or bladder and rectum. "," Lot Number:117568",,"175 units","Pessary mislabeled outer package may not reflect the size of the product contained in the package",2/26/2013,"02/26/2013",4/3/2013,"04/03/2013"
"Devices",64531,"Ongoing","Cooper Surgical, Inc.","Trumbull","CT","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution - USA (nationwide) and internationally to Australia, Canada, Colombia, Demarkt, France, Holland, New ZeaJand, andThailand.","Z-1006-2013","Class III","Cooper Surgical Incontinence Dish w/ Support Pessary #0, 55mm. MilexPart Number: MXKPCONDS00 A pessary is a medical device that is inserted into the vagina to function as a supportive structure of the uterus and/or bladder and rectum. "," Lot Number:111732",,"45 units","Pessary mislabeled outer package may not reflect the size of the product contained in the package",2/26/2013,"02/26/2013",4/3/2013,"04/03/2013"
"Devices",64531,"Ongoing","Cooper Surgical, Inc.","Trumbull","CT","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution - USA (nationwide) and internationally to Australia, Canada, Colombia, Demarkt, France, Holland, New ZeaJand, andThailand.","Z-1005-2013","Class III","Cooper Surgical Incontinence Dish w/ Support Pessary #5, 80mm. Milex:Part Number: MXPCONDS05 A pessary is a medical device that is inserted into the vagina to function as a supportive structure of the uterus and/or bladder and rectum. "," Lot Number:117443",,"18 units","Pessary mislabeled outer package may not reflect the size of the product contained in the package",2/26/2013,"02/26/2013",4/3/2013,"04/03/2013"
"Devices",64531,"Ongoing","Cooper Surgical, Inc.","Trumbull","CT","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution - USA (nationwide) and internationally to Australia, Canada, Colombia, Demarkt, France, Holland, New ZeaJand, andThailand.","Z-1004-2013","Class III","Cooper Surgical Incontinence Ring Flexible Pessary #4, 2 3/4'', 70mm. MilexPart Number: MXPCON04 A pessary is a medical device that is inserted into the vagina to function as a supportive structure of the uterus and/or bladder and rectum. "," Lot Number:117301",,"80 units","Pessary mislabeled outer package may not reflect the size of the product contained in the package",2/26/2013,"02/26/2013",4/3/2013,"04/03/2013"
"Devices",64531,"Ongoing","Cooper Surgical, Inc.","Trumbull","CT","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution - USA (nationwide) and internationally to Australia, Canada, Colombia, Demarkt, France, Holland, New ZeaJand, andThailand.","Z-1009-2013","Class III","Cooper Surgical Gellhorn Flexible Pessary -2 3/4'', 70mm. MilexPart Number: MXPGE2-3/4 A pessary is a medical device that is inserted into the vagina to function as a supportive structure of the uterus and/or bladder and rectum. "," Lot Number:117560",,"275 units","Pessary mislabeled outer package may not reflect the size of the product contained in the package",2/26/2013,"02/26/2013",4/3/2013,"04/03/2013"
"Devices",64531,"Ongoing","Cooper Surgical, Inc.","Trumbull","CT","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution - USA (nationwide) and internationally to Australia, Canada, Colombia, Demarkt, France, Holland, New ZeaJand, andThailand.","Z-1011-2013","Class III","Cooper Surgical Cube Pessary 1 5/8'''', 41mm. Milex Part Number: MXKPEC04 A pessary is a medical device that is inserted into the vagina to function as a supportive structure of the uterus and/or bladder and rectum. "," Lot Number:117376",,"70 units","Pessary mislabeled outer package may not reflect the size of the product contained in the package",2/26/2013,"02/26/2013",4/3/2013,"04/03/2013"
"Drugs",64533,"Ongoing","Novartis Consumer Health","Lincoln","NE","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Nationwide and Panama","D-208-2013","Class III","Nupercainal, Dibucaine, Hemorrhoidal & Topical Analgesic Ointment, a) 1-oz. tubes (NDC 0067-5812-96), b) 2-oz. tubes (NDC 0067-5812-86), OTC. Distributed by Novartis Consumer Health, Inc., Parsippany, NJ 07054.","Lot #: a) 10109149, 10111499, 10117160, 10119603, and 10121763, Exp 4/13 to 8/13; b) 10109148, 10112258, 10113806, 10115615, 10117161, 10119604, 10119605, 10121782, and 10122762, Exp 3/13 to 9/13.","."," 91,872/1-oz. tubes and 94,464/2-oz. tubes","Labeling: Incorrect or Missing Lot and/or Exp Date. The lot number and/or expiration date may be illegible.",3/7/2013,"03/07/2013",3/27/2013,"03/27/2013"
"Drugs",64533,"Ongoing","Novartis Consumer Health","Lincoln","NE","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Nationwide and Panama","D-211-2013","Class III","4 way Saline Moisturizing Mist with Eucalyptol & Menthol, 1-fl. oz. bottles, OTC. Distributed by Novartis Consumer Health, Inc., Parsippany, NJ 07054.","Lot #: 10107922, 10108365, 10108366, 10108367, 10109874, 10110021, 10110022, 10110023, 10110024, and 10120729, Exp 3/14 to 9/14.","."," 227,124 bottles","Labeling: Incorrect or Missing Lot and/or Exp Date. The lot number and/or expiration date may be illegible.",3/7/2013,"03/07/2013",3/27/2013,"03/27/2013"
"Drugs",64533,"Ongoing","Novartis Consumer Health","Lincoln","NE","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Nationwide and Panama","D-210-2013","Class III","4 way Nasal Decongestant Menthol Nasal Spray, containing phenylephrine hydrochloride 1%, a) 1/2-fl. oz. bottles (NDC 0067-2087-05) b) 1-fl. oz. bottles (NDC 0067-2087-01), OTC. Distributed by Novartis Consumer Health, Inc., Parsippany, NJ 07054.","Lot #: a) 10120598, Exp 7/13; 10127563, Exp 11/13; b) 10107920, 10108362, 10108363, 10108364, 10109881, 10110017, 10110018, 10110019, 10110020, 10120730, 10120731, 10120732, 10120733, 10120734, 10120735, 10120736, 10127556, 10127557, 10127558, and 10127559, Exp 3/13 to 10/13.",".","44,604/ .5-fl. oz. bottles and 439,452 /1-fl. oz. bottles","Labeling: Incorrect or Missing Lot and/or Exp Date. The lot number and/or expiration date may be illegible.",3/7/2013,"03/07/2013",3/27/2013,"03/27/2013"
"Drugs",64533,"Ongoing","Novartis Consumer Health","Lincoln","NE","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Nationwide and Panama","D-207-2013","Class III","Myoflex (trolamine salicylate) 10%, Pain Relieving Cream, a) 2-oz tube, b) 4-oz. tube, OTC. The firm name on the label is Novartis Consumer Health, Inc., Parsippany, NJ 07054.","Lot #: a) 10086783, 10088745, 10088746, 10090537, 10093867, 10093868, 10098162, 10098541, 10098542, 10102311, 10109145, 10109146, 10120111, 10122759, and 10122760, Exp 3/13 to 9/14; b) 10086785, 10088747, 10088748, 10090538, 10093869, 10093870, 10098160, 10098161, 10098540, 10099841, 10104146, 10109143, 10109144, 10111501, 10115614, 10120112, 10121759, 10122698, 10122757, and 10122758, Exp 3/13 to 10/14.","."," 240,120/2-oz. tubes and 429,144/4-oz. tubes","Labeling: Incorrect or Missing Lot and/or Exp Date. The lot number and/or expiration date may be illegible.",3/7/2013,"03/07/2013",3/27/2013,"03/27/2013"
"Drugs",64533,"Ongoing","Novartis Consumer Health","Lincoln","NE","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Nationwide and Panama","D-209-2013","Class III","4 way Nasal Decongestant Fast Acting Nasal Spray, containing phenylephrine hydrochloride 1%, a) 1/2-fl. oz. bottles (NDC 0067-2086-05), b) 1-fl. oz. bottles (NDC 0067-2086-01), c) 1.25-fl. oz. bottles (NDC 0067-2086-15), OTC. Distributed by Novartis Consumer Health, Inc., Parsippany, NJ 07054.","Lot #: a) 10108375, 10108376, 10110025, 10110026, 10115487, 10115488, 10120594, 10120595, 10120596, 10120597, 10120753, 10120754, 10120755, 10127564, and 10127567, Exp 4/13 to 11/13, b) 10107916, 10108368, 10108369, 10108370, 10108371, 10108372, 10108373, 10108374, 10110027, 10110028, 10110029, 10110030, 10110031, 10110032, 10110033, 10115803, 10115804, 10115805, 10115806, 10115807, 10115809, 10115810, 10115812, 10115813, 10115814, 10115815, 10120728, 10120737, 10120738, 10120739, 10120740, 10120741, 10120742, 10120743, 10120744, 10120745, 10120746, 10120747, 10120748, 10120749, 10120750, 10120751, 10120752, 10121325, 10127542, 10127543, 10127544, 10127545, 10127546, 10127547, 10127548, 10127549, 10127550, Exp 3/13 to 10/13, c) 10116175, 10117996, 10117997, 10117998, 10117999, 10127535, 10127536, 10127537, 10127538, 10127539, 10127540, and 10127541, Exp 9/13 to 10/13.","."," 538,092/.5-fl. oz. bottles, 1,186,740/1-oz. bottles, and 138,528/1.25-fl. oz bottles","Labeling: Incorrect or Missing Lot and/or Exp Date. The lot number and/or expiration date may be illegible.",3/7/2013,"03/07/2013",3/27/2013,"03/27/2013"
"Food",64534,"Ongoing","Ultradent Products, Inc.","South Jordan","UT","US","Voluntary: Firm Initiated","Letter","USA: AL, CA, GA, IL, IN, MA, MD, MI, NJ, OK, PA, SC, UT; 12 International distributors: Germany, China, France, Spain","F-1271-2013","Class III","Opalescence treswhite Supreme Peach Patient Kit","Lot B6LZS, Part number 5705",,"104 units","Product was packaged into kits labeled as having a shelf life of 2103-05. The correct shelf life is 2013-05.",3/8/2013,"03/08/2013",4/3/2013,"04/03/2013"
"Devices",64535,"Ongoing","Del Mar Reynolds Medical, Ltd.","Hertford",,"GB","Voluntary: Firm Initiated","Letter","Worldwide Distribution - USA Nationwide including the states of New Mexico, North Carolina and the countries of Argentina, China, Mexico, and Taiwan.","Z-0968-2013","Class I","Spacelabs BleaseSirius Anesthesia Workstation, BleaseFocus Anesthesia Workstation, and CAS I/II Absorber contained in Service Kits Part Number 12200902, 050-0659-00 and 050-0901-00 and any workstation instaled with the CAS I/II Absorber. Product Usage: intended for use in the hospital environment and locations not requiring portability. It may be used for the delivery of oxygen, air and nitrous oxide in a controlled manner to various patient-breathing circuits with or without the use of a mechanical ventilator, and may be used for the delivery of anesthetic vapor by use of a dismountable vaporizer. This device is intended for use only by a suitably qualified physician. ","serial numbers: ABSO-004448, ABSO-004458, ABSO-004459, ABSO-004460, ABSO-004461, ABSO-004462, ABSO-004463, ABSO-004465, ABSO-004466, ABSO-004467, ABSO-004468, ABSO-004469, ABSO-004470, ABSO-004471, ABSO-004472, ABSO-004473, ABSO-004474, ABSO-004475, ABSO-004476, ABSO-004477, ABSO-004478, ABSO-004479, ABSO-004480, ABSO-004481, ABSO-004482, ABSO-004483, ABSO-004487, ABSO-004488, ABSO-004489, ABSO-004490, ABSO-004491, ABSO-004492, ABSO-004493, ABSO-004494, ABSO-004495, ABSO-004497, ABSO-004499, ABSO-004500, ABSO-004503, ABSO-004504, ABSO-004505, ABSO-004506, ABSO-004507, ABSO-004508, ABSO-004510, ABSO-004511, ABSO-004512, ABSO-004513, ABSO-004526, ABSO-004528, ABSO-004529, ABSO-004530, ABSO-004531, ABSO-004532, ABSO-004533, ABSO-004534, ABSO-004535, ABSO-004536, ABSO-004537, ABSO-004538, ABSO-004539, ABSO-004540, ABSO-004541, ABSO-004542, ABSO-004543, ABSO-004544, ABSO-004545, ABSO-004564, ABSO-004566, ABSO-004567, ABSO-004568, ABSO-004569, ABSO-005883, ABSO-005884, ABSO-005885, ABSO-005886, ABSO-005887, ABSO-005945, ABSO-005947, ABSO-005948, ABSO-005949, ABSO-005950, ABSO-100023, ABSO-100024, ABSO-100038, ABSO-100039, ABSO-100040, ABSO-100041, ABSO-100042, ABSO-100043, ABSO-100070, ABSO-100071, ABSO-100072, ABSO-100073, ABSO-100074, ABSO-100075, ABSO-100076, ABSO-100077, ABSO-100078, ABSO-100079, ABSO-100080, ABSO-100081, ABSO-100082, ABSO-100083, ABSO-100084, ABSO-100085, ABSO-100086, and ABSO-100087. ",".","108 total (17 units in the US and 91 units outside the US)","A defect in CAS I/II Absorbers in the Spacelabs Anesthesia Workstations and Service Kits may cause a condition leading to an increase in the carbon dioxide concentration within the inspired gas being delivered to the patient.",1/15/2013,"01/15/2013",3/27/2013,"03/27/2013"
"Food",64536,"Ongoing","Bumble Bee International","San Diego","CA","US","Voluntary: Firm Initiated","Letter","US states nationwide.","F-1288-2013","Class II","Brunswick and Bumble Bee Brand 5oz Chunk Light Tuna in Water. ","Lot Code & Best By Date3014SAECLP 1/14/2016 3015SA1CLP 1/15/2016 3015SA2CLP 1/15/2016 3015SA3CLP 1/15/2016 3015SA4CLP 1/15/2016 3015SA5CLP 1/15/2016 3015SAACLP 1/15/2016 3015SABCLP 1/15/2016 3015SACCLP 1/15/2016 3015SADCLP 1/15/2016 3015SAECLP 1/15/2016 3016SB1CLP 1/16/2016 3016SB2CLP 1/16/2016 3016SB3CLP 1/16/2016 3016SB4CLP 1/16/2016 3016SBACLP 1/16/2016 3016SBBCLP 1/16/2016 3016SBCCLP 1/16/2016 3016SBDCLP 1/16/2016 3016SBECLP 1/16/2016 3017SB1CLP 1/17/2016 3017SB3CLP 1/17/2016 3017SB4CLP 1/17/2016 3017SB5CLP 1/17/2016 3017SB6CLP 1/17/2016 3017SBACLP 1/17/2016 3017SBBCLP 1/17/2016 3017SBCCLP 1/17/2016 3017SBDCLP 1/17/2016 3017SBECLP 1/17/2016 3018SB1CLP 1/18/2016 3018SB2CLP 1/18/2016 3018SB4CLP 1/18/2016 3018SB5CLP 1/18/2016 3018SBACLP 1/18/2016 3018SBBCLP 1/18/2016 3018SBCCLP 1/18/2016 3018SBDCLP 1/18/2016 3018SBECLP 1/18/2016 ",".","37,482 cases","Bumble Bee Foods, LLC, has issued a voluntary recall on specific codes of 5-ounce Chunk White Albacore and Chunk Light Tuna products. The recall has been issued because the products do not meet the companys standards for seal tightness.",3/1/2013,"03/01/2013",4/10/2013,"04/10/2013"
"Food",64536,"Ongoing","Bumble Bee International","San Diego","CA","US","Voluntary: Firm Initiated","Letter","US states nationwide.","F-1289-2013","Class II","Bumble Bee Brand 5oz Chunk Light Tuna in Vegetable Oil ","Lot Code & Best By Date3016SA1CLH 1/16/2018 3016SA5CLH 1/16/2018 3016SAACLH 1/16/2018 3016SABCLH 1/16/2018 3016SACCLH 1/16/2018 3016SADCLH 1/16/2018 3016SAECLH 1/16/2018 3016SAFCLH 1/16/2018 3016SAFCLH 1/18/2018 ",".","9940 cases","Bumble Bee Foods, LLC, has issued a voluntary recall on specific codes of 5-ounce Chunk White Albacore and Chunk Light Tuna products. The recall has been issued because the products do not meet the companys standards for seal tightness.",3/1/2013,"03/01/2013",4/10/2013,"04/10/2013"
"Food",64536,"Ongoing","Bumble Bee International","San Diego","CA","US","Voluntary: Firm Initiated","Letter","US states nationwide.","F-1290-2013","Class II","Bumble Bee Brand 5oz Chunk White Albacore in Water","Lot Code & Best By Date3016SA2CKP 1/16/2016 3016SA3CKP 1/16/2016 3016SA4CKP 1/16/2016 3017SA1CKP 1/17/2016 3017SA2CKP 1/17/2016 3017SA3CKP 1/17/2016 3017SA4CKP 1/17/2016 3017SA5CKP 1/17/2016 3017SADCKP 1/17/2016 3017SAECKP 1/17/2016 3017SAFCKP 1/17/2016 3017SABCKP 1/17/2016 3017SAACKP 1/17/2016 3017SACCKP 1/17/2016 3017SB2.CKP 1/17/2016 ",".","6692 cases","Bumble Bee Foods, LLC, has issued a voluntary recall on specific codes of 5-ounce Chunk White Albacore and Chunk Light Tuna products. The recall has been issued because the products do not meet the companys standards for seal tightness.",3/1/2013,"03/01/2013",4/10/2013,"04/10/2013"
"Devices",64537,"Ongoing","Polymedco, Inc","Cortlandt Manor","NY","US","Voluntary: Firm Initiated","Telephone","Worldwide Distribution-USA (nationwide) including Puerto Rico, and the countries of Canada and Guam.","Z-1059-2013","Class II","Test Strips packaged in the OC-Light Manual iFOBT Kit, Catalog No. FOB50. For the rapid, qualitative detection of human hemoglobin in feces.","Kit Lot # P205877 - Kit Expiration Date 2/28/2013 - Test Strip Lot # 18004M; Kit Lot # P210125 - Kit Expiration Date 3/31/2013 - Test Strip Lot # 19006M; Kit Lot # P210204 - Kit Expiration Date 3/31/2013 - Test Strip Lot # 19006M; Kit Lot # P212420 - Kit Expiration Date 4/30/2013 - Test Strip Lot # 1X009M; Kit Lot # P212421 - Kit Expiration Date 4/30/2013 - Test Strip Lot # 1X009M; Kit Lot # P210194 - Kit Expiration Date 4/30/2013 - Test Strip Lot # 1X010M; Kit Lot # P217043 - Kit Expiration Date 5/31/2013 - Test Strip Lot # 1Y012M; Kit Lot # P234499 - Kit Expiration Date 11/30/2013 - Test Strip Lot # 25011M; Kit Lot # P234664 - Kit Expiration Date 11/30/2013 - Test Strip Lot # 26012M; Kit Lot # P238025 - Kit Expiration Date 12/31/2013 - Test Strip Lot # 26012M; Kit Lot # P238028 - Kit Expiration Date 12/31/2013 - Test Strip Lot # 26013M; Kit Lot # P243938 - Kit Expiration Date 12/31/2013 - Test Strip Lot # 26012M. ",".","355,350 test strips","The test strips in the affected product lots of the OC Light immunological fecal occult blood test are being recalled because they may not be stable through their labeled shelf-life. There may be a possibility of obtaining false negative results when using the affected lots. ",2/12/2013,"02/12/2013",4/10/2013,"04/10/2013"
"Devices",64537,"Ongoing","Polymedco, Inc","Cortlandt Manor","NY","US","Voluntary: Firm Initiated","Telephone","Worldwide Distribution-USA (nationwide) including Puerto Rico, and the countries of Canada and Guam.","Z-1060-2013","Class II","Test Strips packaged in the OC-Light Manual iFOBT Kit, Catalog No. FOBSTR. For the rapid, qualitative detection of human hemoglobin in feces.","Kit Lot # P207830 - Kit Expiration Date 2/28/2013 - Test Strip Lot # 18005M; Kit Lot # P210191 - Kit Expiration Date 4/30/2013 - Test Strip Lot # 1X009M Kit Lot # P210192 - Kit Expiration Date 4/30/2013 - Test Strip Lot # 1X010M; Kit Lot # P217033 - Kit Expiration Date 5/31/2013 - Test Strip Lot # 1Y011M; Kit Lot # P217034 - Kit Expiration Date 5/31/2013 - Test Strip Lot # 1Y012M; Kit Lot # P217035 - Kit Expiration Date 6/30/2013 - Test Strip Lot # 1Z013M; Kit Lot # P222808 - Kit Expiration Date 6/30/2013 - Test Strip Lot # 1Z013M.",".","229,600 test strips","The test strips in the affected product lots of the OC Light immunological fecal occult blood test are being recalled because they may not be stable through their labeled shelf-life. There may be a possibility of obtaining false negative results when using the affected lots. ",2/12/2013,"02/12/2013",4/10/2013,"04/10/2013"
"Devices",64538,"Ongoing","Elana, Inc.","Columbia","MD","US","Voluntary: Firm Initiated","Letter","Distributed in the states of Pennsylvania, Texas, and New York.","Z-1143-2013","Class II","Elana Catheter Sizer 2.0*** The Elana Catheter Sizer 2.0 is designed to aid the surgeon to assess the bypass graft of the ELANA technique.","Model 280, S/N 776, S/N 706, S/N 758",".","3 devices","Distribution of an unapproved device into interstate commerce.",2/14/2013,"02/14/2013",4/24/2013,"04/24/2013"
"Veterinary",64539,"Ongoing","Steve's Real Food, Inc.","Murray","UT","US","Voluntary: Firm Initiated","Telephone","Distributed to four distributors in CA, TN, RI, and MN. No foreign, government, or military distribution.","V-294-2013","Class I","Steve's Real Food TURDUCKEN CANINE RECIPE, 5 lbs bags of 8 oz patties, UPC 6-91730-14204-9, Expiration 10/27/13, MFR # 83. Raw Frozen Dog Food, Distributed by Steve's Real Food Inc, Aumsville, OR 97086","Lot B209",".","39 cases/156 bags","Steve's Real Food is recalling certain lots of Turducken Canine Recipe due to possible salmonella contamination. ",3/7/2013,"03/07/2013",8/14/2013,"08/14/2013"
"Food",64540,"Ongoing","Kroger Co","Cincinnati","OH","US","Voluntary: Firm Initiated","Press Release","Product was distributed to the following states: ID, OR & WA.","F-1280-2013","Class II","Kroger Value Wheat Bread, PAN DE TRIGO, net wt/peso neto 22.5 oz (1 lb 6.5 oz) 637g UNBLEACHED ENRICHED FLOUR***CONTAINS: WHEAT AND SOY.*** DISTRIBUTED BY/DISTRIBUIDO OR THE KROGER CO., CINCINNATI, OHIO 45202.","Sell By Mar 08 FK 053, UPC 0 11110 02199 1",".","2,532/22.5 oz loaves","The firm was notified of bread with traces of visible ink was discovered which later led to the discovery of plastic pen pieces.",2/26/2013,"02/26/2013",4/10/2013,"04/10/2013"
"Food",64540,"Ongoing","Kroger Co","Cincinnati","OH","US","Voluntary: Firm Initiated","Press Release","Product was distributed to the following states: ID, OR & WA.","F-1283-2013","Class II","Fred Meyer Tender Twist Honey Cracked Wheat Bread 24 oz (1 LB 8 OZ) 680g***INGREDIENTS: UNBLEACHED ENRICHED FLOUR***CONTAINS: WHEAT, SOY. DISTRIBUTED BY THE KROGER CO. CINCINNATI, OHIO 45202''","UPC 0 11110 23004 Sell By Mar 08 FK 053 ",".","207/24 oz loaves","The firm was notified of bread with traces of visible ink was discovered which later led to the discovery of plastic pen pieces.",2/26/2013,"02/26/2013",4/10/2013,"04/10/2013"
"Food",64540,"Ongoing","Kroger Co","Cincinnati","OH","US","Voluntary: Firm Initiated","Press Release","Product was distributed to the following states: ID, OR & WA.","F-1282-2013","Class II","Tender Twist 100% Whole Wheat Bread 24 oz (1 LB 8 OZ) 680g***INGREDIENTS: UNBLEACHED ENRICHED FLOUR***CONTAINS: WHEAT, SOY. DISTRIBUTED BY THE KROGER CO. CINCINNATI, OHIO 45202'' Sold under the following brand names: Fred Meyer & Goodyman","UPC 0 11110 23005 8 Sell By Mar 08 FK 053 ",".","790/24 oz loaves","The firm was notified of bread with traces of visible ink was discovered which later led to the discovery of plastic pen pieces.",2/26/2013,"02/26/2013",4/10/2013,"04/10/2013"
"Food",64540,"Ongoing","Kroger Co","Cincinnati","OH","US","Voluntary: Firm Initiated","Press Release","Product was distributed to the following states: ID, OR & WA.","F-1281-2013","Class II","Tender Twist Wheat Bread NET WT 20 OZ (1 LB 4 OZ) 566G and 22.5 oz (1 LB 6.5 OZ) 637 g plastic bags ***INGREDIENTS: UNBLEACHED ENRICHED FLOUR***CONTAINS: WHEAT, SOY. DISTRIBUTED BY THE KROGER CO. CINCINNATI, OHIO 45202'' Sold under the following brands: QFC Quality Food Centers & Fred Meyer","UPC 0 11110 20231 4, Sell By Mar 08 FK 053 & UPC 0 11110 23006 6, Sell By Mar 08 FK 053",".","1,128/20 oz loaves & 168/22.5 oz loaves","The firm was notified of bread with traces of visible ink was discovered which later led to the discovery of plastic pen pieces.",2/26/2013,"02/26/2013",4/10/2013,"04/10/2013"
"Drugs",64541,"Ongoing","RX South LLC DBA RX3 Pharmacy","Chester","VA","US","Voluntary: Firm Initiated","Letter","Nationwide","D-191-2013","Class II","Medi-bolic Booster Injectable (methionine 8.3 mg/mL, choline chloride 16.6 mg/mL, inositol 16.6 mg/mL, cyanocobalamin USP [Vit B12] 0.33 mg/mL, chromium chloride 2.6 mg/mL), 30 mL multi-dose vials, Rx3 Compounding Pharmacy, 12230 Ironbridge Rd., Suite C, Chester, VA 23831.","Lot #: 10292012:56, Exp 01/27/13 and 10302012:77, Exp 01/28/13",,"126 vials","CGMP Deviations: Pharmaceutical for injection was not manufactured according to Good Manufacturing Procedures.",1/22/2013,"01/22/2013",3/13/2013,"03/13/2013"
"Drugs",64541,"Ongoing","RX South LLC DBA RX3 Pharmacy","Chester","VA","US","Voluntary: Firm Initiated","Letter","Nationwide","D-191-2013","Class II","Medi-bolic Booster Injectable (methionine 8.3 mg/mL, choline chloride 16.6 mg/mL, inositol 16.6 mg/mL, cyanocobalamin USP [Vit B12] 0.33 mg/mL, chromium chloride 2.6 mg/mL), 30 mL multi-dose vials, Rx3 Compounding Pharmacy, 12230 Ironbridge Rd., Suite C, Chester, VA 23831. ","Lot #: 10292012:56, Exp 01/27/13 and 10302012:77, Exp 01/28/13",,"126 vials","CGMP Deviations: Pharmaceutical for injection was not manufactured according to Good Manufacturing Procedures.",1/22/2013,"01/22/2013",3/20/2013,"03/20/2013"
"Devices",64543,"Ongoing","Smiths Medical ASD, Inc.","Saint Paul","MN","US","Voluntary: Firm Initiated","Letter","USA Nationwide Distribution - including the states of: CO, IL, IN, MA, SC and WI.","Z-1014-2013","Class I","Smiths Medical, BCI Remote Alarm Cable (Normally Open & Normally Closed), Reorder Numbers: WW3398NO & WW3398NC. For use with respiration carbon dioxide measurement equipment. Product Usage: The BCI Remote Alarm Cable is designed for use with the 9004 Capnocheck Capnography (Plus or Sleep) system to transfer alarm signals from the Capnocheck Capnography system to a remote alarm system. The BCI Remote Alarm Cable and the 9004 Capnocheck Capnography systems are intended for use in all critical environments including ventilatory applications, patient transport, and anesthesia.","Lot Numbers: WW3398NO0820, WW3398NO0847, WW3398NO0948, WW3398NC0822, WW3398NC0847, WW3398NC0947.",".","39","In rare instances, the BCI Remote Alarm Cables (BCI Cable) are not transferring alarms when used with some remote nurse alarm systems.",2/6/2013,"02/06/2013",4/10/2013,"04/10/2013"
"Devices",64546,"Ongoing","Boston Scientific CRM Corp","Saint Paul","MN","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution, USA including the states of AZ, CA, CO, DC, GA, IL, MD, MA, MN, NJ, NY, NC, OH, PA, SC, VA, WA and the countries of AUSTRIA, BELGIUM, CANDA, CZECH REPUBLIC, DENMARK, FRANCE, GERMANY, IRELAND, ITALY, NETHERLANDS, NEW ZEALAND, PORTUGAL, SLOVAKIA, SPAIN, SWEDEN, SWITZERLAND, and the UNITED KINGDOM.","Z-0965-2013","Class II","Boston Scientific/Cameron SQ-RX Model 1010 subcutaneous pulse generators. The S-ICD System is intended to provide therapy for the treatment of life-threatening ventricular tachyarrhythmias.","SERIAL NUMBERS A002804 A003105 A001493 A001784 A001981 A003024 A003197 A001609 A001594 A001733 A002291 A002348 A002373 A002195 A002710 A004131 A001942 A002278 A002399 A002402 A001021 A001136 A001104 A001193 A001392 A002093 A002147 A001134 A001155 A001063 A001011 A001102 A001012 A001004 A001058 A001010 A001140 A001093 A001170 A001055 A001185 A001144 A001217 A001215 A001241 A001367 A001377 A001405 A001431 A001380 A001468 A001411 A001639 A001688 A001734 A001578 A001654 A001799 A001916 A001903 A002127 A002076 A002425 A002686 297-899 300-895 292-887 A001120 A001085 A001109 A001089 A001122 A001110 A001020 A001052 A001023 A001051 A001062 A001148 A001042 A001106 A001091 A001096 A001126 A001237 A001341 A001354 A001447 A001429 A001533 A001481 A001236 A001119 A001246 A001384 A001267 A001731 A001650 A001774 A001856 A001980 A001752 A002364 A002823 A002826 A002833 A002858 A002889 A002892 A002946 A002997 A002996 A002953 A003386 A003465 A003066 A003382 A003426 A003540 A003563 A001291 A001463 A002985 A001146 A001174 A001040 A001005 A001053 A001180 A001195 A001194 A001188 A001233 A001270 A001273 A001197 A001294 A001368 A001338 A001332 A001152 A001423 A001344 A001443 A001235 A001317 A001363 A001512 A001513 A001538 A001489 A001480 A001334 A001500 A001820 A001680 A001647 A001652 A001630 A001696 A001789 A001740 A001781 A001271 A001711 A001661 A001573 A001772 A001636 A001682 A001750 A001437 A001882 A002050 A002036 A002045 A001910 A002015 A001888 A002068 A001605 A002005 A001860 A002234 A002300 A002337 A002087 A002295 A002272 A002141 A002261 A002243 A001958 A002266 A002014 A002071 A001768 A002158 A002286 A002403 A002194 A002228 A002292 A002418 A002252 A002342 A002459 A002374 A002424 A002485 A002276 A002523 A002027 A002376 A002672 A002645 A002267 A002553 A002608 A002737 A002999 A003124 A003138 A003285 A003449 A004002 A003886 A003694 A003842 A001732 A001660 A001800 A001427 A001418 A001428 A001441 A001454 A001635 A001566 A001697 A001653 A001634 A001811 A001623 A001837 A001793 A001745 A001905 A001863 A001867 A001887 A001588 A001808 A00195",".","2090 (570 USA; 1520 OUS)","Boston Scientific is conducting a recall on Cameron Health /Boston Scientific subcutaneous defibrillators (S-ICD System). BS identified a rare condition in which an internal protective fuse can be unintentionally activated while the device is charging its capacitors for shock delivery or induction. Should this occur, the defibrillator would not be able to deliver therapy or communicate with the Q-TECH Model 2020 programmer, and would be unable to emit tones or otherwise respond to magnet application. No patient deaths or injuries have been reported as a result of this behavior; affected devices were replaced without the need for emergency medical care.",3/1/2013,"03/01/2013",3/27/2013,"03/27/2013"
"Devices",64547,"Ongoing","Philips Medical Systems (Cleveland) Inc","Cleveland","OH","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution - (USA) Nationwide Distribution including the states of AL, AR, AZ, CA, FL, GA, IA, IN, LA, MI, MN, MO, NC, NJ, NY, OH, OK, OR, PA, TN, TX, WA, WI & WV. and the countries of Australia, Austria, Belgium, Canada, China, Czech Republic, Denmark, Egypt, Finland, France, France, Germany, Greece, Hungary, India, Indonesia, Ireland, Israel, Italy, Japan, Latvia, Lebanon, Monaco, Netherlands, Norway, Poland, Portugal, Russia, Slovakia, South Africa, South Korea, Spain, Sweden, Switzerland, Thailand & United Kingdom","Z-1102-2013","Class II","Intellispace Portal (ISP) Philips Medical Systems (Cleveland), Inc., IntelliSpace Portal (ISP) is a multimodality (CT, NM, and MR) thin-client applications server that delivers full diagnostic viewing and clinical applications to the enterprise. IntelliSpace Portal (ISP) is a medical software system that allows multiple users to remotely access IntelliSpace Workspace Portal (ISP) from compatible computers on a network. The system allows networking, selection, processing and filming of multimodality DICOM images. Both the client and server software are only for use with off the shelf hardware technology that meets defined minimum specifications. trained physicians may use the images as a basis for diagnosis upon ensuring that monitor quality, ambient light conditions and image compression ratios are consistent with clinical application.","Model #881001, Serial #s: 79916, 79932, 79933, 79935, 79936, 79937, 79939, 79940, 79943, 80071, 80914, 80916, 80925, 80926, 80928, 80932, 80939, 80963, 80965, 80977, 80979, 80994, 80995, 81004, 81006, 81008, 81010, 81026, 81027, 81028, 81034, 81035, 81036, 81039, 81063, 81065, 81076, 81079, 81081, 81085, 81089, 81097, 81098, 81108, 81110, 81117, 81119, 81127, 81130, 81132, 81133, 81150, 81153, 81154, 81160, 81161, 81163, 81165, 81169, 81172, 81173, 81174, 81175, 81178, 81179, 81182, 81183, 81184, 81187, 81189, 81190, 81192, 81194, 81196, 81200, 82001, 82002, 82003, 82004, 82006, 82007, 82008, 82009, 82010, 82011, 82012, 82013, 82014, 82015, 82016, 82017, 82018, 82019, 82020, 82021, 82022, 82023, 82024, 82025, 82026, 82027, 82028, 82029, 82030, 82031, 82032, 82033, 82034, 82035, 82036, 82037, 82038, 82050, 82051, 82052, 82053, 82054, 82055, 82056, 82057, 82058, 82059, 82060, 82061, 82062, 82063, 82064, 82065, 82066, 82067, 82068, 82069, 82070, 82071, 82072, 82073, 82074, 82084, 82086, 82087, 82088, 82089, 82090, 82091, 82092, 82095, 82097, 82098, 82099, 82100, 82101, 82102, 82103, 82104, 82105, 82106, 82107, 82108, 82109, 82110, 82112, 82116, 82118, 82120, 82121, 82123, 82125, 82126, 82128, 82129, 82130, 82131, 82132, 82133, 82138, 82142, 82143, 82144, 82146, 82148, 82201, 82202, 82203, 82236, 82238, 82240, 82241, 82250, 82251, 85005, 85006, 85007, 85008, 85009, 85010, 85011, 85014, 85025, 85026, 85027, 85028, 85029, 85031, 85032, 85033, 85040, 85041, 85042, 85043, 85044, 85046, 85047, 85049, 85050, 85066, 85067, 85068, 85069, 85080, 85081, 85082, 85083, 85084, 85086, 85088, 85090, 85096, 85103, 85104, 85105, 85106, 85107, 85108, 85110, 85117, 85141, 85143, 85144, 85145, 85149, 85164, 85165, 85167, 85168, 85169, 85170, 85171, 85172, 85174, 85175, 85176, 85177, 85178, 85179, 85180, 85213, 85214, 85215, 85216, 85217, 85218, 85219, 85238, 85239, 85243, 85244, 85245, 85246, 85247, 85248, 85249, 85250, 85252, 85253, 85254, 85255, 85257, 85260, 85296, 85299, 85300, 85302, 85305, 85306, 85307, 85308, 85309, 85312, 85",".","313 units","Philips was notified of a problem using the IntelliSpace Portal with software version 4.0.2 with the URL PACS integration. Philips was informed that when loading a study to an analysis application while using URL PACS integration configuration, after another study was opened by a review application, the Analysis monitor is updated with the study of the current patient, but the Review monitor continues to display the study from the previous patient. If the issues were to re-occur, it could pose a risk for the patient.",2/12/2013,"02/12/2013",4/24/2013,"04/24/2013"
"Food",64548,"Ongoing","Tri-Union Seafoods, L.L.C dba Chicken of the Sea.","San Diego","CA","US","Voluntary: Firm Initiated","E-Mail","US states nationwide.","F-1274-2013","Class II","Chicken of the Sea Brand 5-ounce chunk whitealbacore tuna in water. UPC: 4800003355, Case UPC 4800003355: 24 cans per case, Shipper display UPC 4800016335: 80 cans per case, Pallet display UPC 4800023355: 1008 cans per pallet Product labeling reads in part:''***Chicken of the Sea CHUNK WHITE ALBACORE TUNA IN WATER***NET WT. 5 OZ (142g)***Send product comments to***Chicken of the Sea Intl.,***P.O. Box 85568, San Diego, CA 92186-5568***''. ","3018CA2CKP, 3018CA3CKP, 3018CA4CKP, 3018CAACKP, 3018CABCKP, 3018CACCKP, 3018CAECKP, 3018CB3CKP, 3018CADCKP BEST BY DATE: 01/18/17.",".","5894 cases","Tri-Union Seafoods LLC is voluntarily recalling a limitedamount of Chicken of the Sea brand 5-ounce cans of chunk white albacore tuna in water and Chicken of the Sea brand 5-ounce cans chunk light tuna in oil, because the seams on the lids of the cans do not meet the standard for seam quality.",3/4/2013,"03/04/2013",4/10/2013,"04/10/2013"
"Food",64548,"Ongoing","Tri-Union Seafoods, L.L.C dba Chicken of the Sea.","San Diego","CA","US","Voluntary: Firm Initiated","E-Mail","US states nationwide.","F-1275-2013","Class II","Chicken of the Sea 5-Ounce Chunk Light Tuna in Oil.Sold in single cans. 24 cans per case. UPC 48000 00195 Product labeling reads in part:''***Chicken of the Sea CHUNK LIGHT TUNA IN OIL***NET WT. 5 OZ (142g)***Send product comments to***Chicken of the Sea Intl.,***P.O. Box 85568, San Diego, CA 92186-5568***''. ","3015CB1CLH3015CB2CLH 3015CB3CLH 3015CB4CLH 3015CBACLH 3015CBBCLH 3015CBCCLH 3015CBDCLH 3015CBECLH BEST BY DATE 01/15/17 and 01/18/17",".","21597 cases","Tri-Union Seafoods LLC is voluntarily recalling a limitedamount of Chicken of the Sea brand 5-ounce cans of chunk white albacore tuna in water and Chicken of the Sea brand 5-ounce cans chunk light tuna in oil, because the seams on the lids of the cans do not meet the standard for seam quality.",3/4/2013,"03/04/2013",4/10/2013,"04/10/2013"
"Veterinary",64549,"Ongoing","Central Garden Pet Company","Phoenix","AZ","US","Voluntary: Firm Initiated","Press Release","Nationwide including Puerto Rico, OUS to include: Canada, China, Indonesia, Japan, Kuwait, Panama, Pakistan, Singapore, South Korea, United Arab Emirates.","V-233-2013","Class I","Kaytee Forti-Diet Pro Health Honey Treat, Parakeet, Net Wt. 3.5 oz, UPC 71859-94235, 7 oz Value Pack UPC 71859-94236 ","Best Before Code (month/day/year) 12/4/2013 thru 8/1/2014",,"99,977 eaches total","Kaytee Products is recalling several bird treats and greens items due to possible contamination of Salmonella from parsley flake ingredients supplied to Kaytee by Specialty Commodities, Inc.",2/19/2013,"02/19/2013",7/31/2013,"07/31/2013"
"Veterinary",64549,"Ongoing","Central Garden Pet Company","Phoenix","AZ","US","Voluntary: Firm Initiated","Press Release","Nationwide including Puerto Rico, OUS to include: Canada, China, Indonesia, Japan, Kuwait, Panama, Pakistan, Singapore, South Korea, United Arab Emirates.","V-236-2013","Class I","Kaytee Fiesta Nutty Papaya Treat, Parakeet & Cockatiel, Net Wt. 2.25 oz, UPC 71859-94368","Best Before Code (month/day/year) 12/4/2013 thru 6/25/2014",,"99,977 eaches total","Kaytee Products is recalling several bird treats and greens items due to possible contamination of Salmonella from parsley flake ingredients supplied to Kaytee by Specialty Commodities, Inc.",2/19/2013,"02/19/2013",7/31/2013,"07/31/2013"
"Veterinary",64549,"Ongoing","Central Garden Pet Company","Phoenix","AZ","US","Voluntary: Firm Initiated","Press Release","Nationwide including Puerto Rico, OUS to include: Canada, China, Indonesia, Japan, Kuwait, Panama, Pakistan, Singapore, South Korea, United Arab Emirates.","V-232-2013","Class I","Kaytee Fiesta Fruit & Veggie Treat, Parakeet, Net Wt. 3.5 oz, UPC 71859-99885, 9.5 oz UPC 71859-99855, ","Best Before Code (month/day/year) 12/18/2013 thru 7/31/2014",,"99,977 eaches total","Kaytee Products is recalling several bird treats and greens items due to possible contamination of Salmonella from parsley flake ingredients supplied to Kaytee by Specialty Commodities, Inc.",2/19/2013,"02/19/2013",7/31/2013,"07/31/2013"
"Veterinary",64549,"Ongoing","Central Garden Pet Company","Phoenix","AZ","US","Voluntary: Firm Initiated","Press Release","Nationwide including Puerto Rico, OUS to include: Canada, China, Indonesia, Japan, Kuwait, Panama, Pakistan, Singapore, South Korea, United Arab Emirates.","V-239-2013","Class I","Kaytee Foraging Box O' Fun Treat for Pet Birds, Net Wt. 1.5 oz, UPC 71859-94615","Best Before Code (month/day/year) 1/28/2014 thru 7/30/2014",,"99,977 eaches total","Kaytee Products is recalling several bird treats and greens items due to possible contamination of Salmonella from parsley flake ingredients supplied to Kaytee by Specialty Commodities, Inc.",2/19/2013,"02/19/2013",7/31/2013,"07/31/2013"
"Veterinary",64549,"Ongoing","Central Garden Pet Company","Phoenix","AZ","US","Voluntary: Firm Initiated","Press Release","Nationwide including Puerto Rico, OUS to include: Canada, China, Indonesia, Japan, Kuwait, Panama, Pakistan, Singapore, South Korea, United Arab Emirates.","V-235-2013","Class I","Kaytee Forti-Diet Pro Health Molting & Conditioning, Small Birds, Net Wt. 11 oz, UPC 71859-94264","Best Before Code (month/day/year) 12/25/2013 thru 8/5/2014",,"99,977 eaches total","Kaytee Products is recalling several bird treats and greens items due to possible contamination of Salmonella from parsley flake ingredients supplied to Kaytee by Specialty Commodities, Inc.",2/19/2013,"02/19/2013",7/31/2013,"07/31/2013"
"Veterinary",64549,"Ongoing","Central Garden Pet Company","Phoenix","AZ","US","Voluntary: Firm Initiated","Press Release","Nationwide including Puerto Rico, OUS to include: Canada, China, Indonesia, Japan, Kuwait, Panama, Pakistan, Singapore, South Korea, United Arab Emirates.","V-234-2013","Class I","Kaytee Forti-Diet Pro Health Munchables Shred-A-Box, Honey Seed Treats, Parakeet, 4 boxes, Net Wt. 2 oz, UPC 71859-94268","Best Before Code (month/day/year) 3/7/2014 thru 7/30/2014",,"99,977 eaches total","Kaytee Products is recalling several bird treats and greens items due to possible contamination of Salmonella from parsley flake ingredients supplied to Kaytee by Specialty Commodities, Inc.",2/19/2013,"02/19/2013",7/31/2013,"07/31/2013"
"Veterinary",64549,"Ongoing","Central Garden Pet Company","Phoenix","AZ","US","Voluntary: Firm Initiated","Press Release","Nationwide including Puerto Rico, OUS to include: Canada, China, Indonesia, Japan, Kuwait, Panama, Pakistan, Singapore, South Korea, United Arab Emirates.","V-240-2013","Class I","Kaytee Bird Greens Foraging Treat, Net Wt. 1 oz, UPC 71859-94708","Best Before Code (month/day/year) 12/1/2013 thru 5/28/2014 ",,"99,977 eaches total","Kaytee Products is recalling several bird treats and greens items due to possible contamination of Salmonella from parsley flake ingredients supplied to Kaytee by Specialty Commodities, Inc.",2/19/2013,"02/19/2013",7/31/2013,"07/31/2013"
"Veterinary",64549,"Ongoing","Central Garden Pet Company","Phoenix","AZ","US","Voluntary: Firm Initiated","Press Release","Nationwide including Puerto Rico, OUS to include: Canada, China, Indonesia, Japan, Kuwait, Panama, Pakistan, Singapore, South Korea, United Arab Emirates.","V-230-2013","Class I","Kaytee Fiesta Max Canary/Finch, Net Wt. 2 lb., UPC 71859-40410","Best Before Code (month/day/year) 9/28/2013 thru 5/7/2014",,"99,977 eaches total","Kaytee Products is recalling several bird treats and greens items due to possible contamination of Salmonella from parsley flake ingredients supplied to Kaytee by Specialty Commodities, Inc.",2/19/2013,"02/19/2013",7/31/2013,"07/31/2013"
"Veterinary",64549,"Ongoing","Central Garden Pet Company","Phoenix","AZ","US","Voluntary: Firm Initiated","Press Release","Nationwide including Puerto Rico, OUS to include: Canada, China, Indonesia, Japan, Kuwait, Panama, Pakistan, Singapore, South Korea, United Arab Emirates.","V-231-2013","Class I","Kaytee Honey Treat, Parakeet, Net Wt. 3.5 oz, UPC 71859-00431, 3.5 oz UPC 71859-00434, and 7 oz Value Pack UPC 71859-55027","Best Before Code (month/day/year) 12/4/2013 thru 8/2/2014",,"99,977 eaches total","Kaytee Products is recalling several bird treats and greens items due to possible contamination of Salmonella from parsley flake ingredients supplied to Kaytee by Specialty Commodities, Inc.",2/19/2013,"02/19/2013",7/31/2013,"07/31/2013"
"Veterinary",64549,"Ongoing","Central Garden Pet Company","Phoenix","AZ","US","Voluntary: Firm Initiated","Press Release","Nationwide including Puerto Rico, OUS to include: Canada, China, Indonesia, Japan, Kuwait, Panama, Pakistan, Singapore, South Korea, United Arab Emirates.","V-238-2013","Class I","Grreat Choice Treat Sticks for Small Birds, Net Wt. 3.2 oz, UPC 37257-27166, 9.6 oz, UPC 37257-27165","Best Before Code (month/day/year) 12/10/2013 thru 3/19/2014",,"99,977 eaches total","Kaytee Products is recalling several bird treats and greens items due to possible contamination of Salmonella from parsley flake ingredients supplied to Kaytee by Specialty Commodities, Inc.",2/19/2013,"02/19/2013",7/31/2013,"07/31/2013"
"Veterinary",64549,"Ongoing","Central Garden Pet Company","Phoenix","AZ","US","Voluntary: Firm Initiated","Press Release","Nationwide including Puerto Rico, OUS to include: Canada, China, Indonesia, Japan, Kuwait, Panama, Pakistan, Singapore, South Korea, United Arab Emirates.","V-237-2013","Class I","Kaytee Fiesta Foraging Treat for Pet Birds, Net Wt. 1.5 oz, UPC 71859-94370","Best Before Code (month/day/year) 1/27/2014 thru 5/29/2014",,"99,977 eaches total","Kaytee Products is recalling several bird treats and greens items due to possible contamination of Salmonella from parsley flake ingredients supplied to Kaytee by Specialty Commodities, Inc.",2/19/2013,"02/19/2013",7/31/2013,"07/31/2013"
"Devices",64550,"Ongoing","Hill-Rom, Inc.","Batesville","IN","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution-USA (nationwide) including the states of AZ, CA, CO, FL, IL, IN, KS, LA, MA, MI, MN, MO, NC, NH, NJ, NV, OH, OK, PA, SC, TN, UT, WA, and WI, and the countries of Canada, Australia, Austria, Belgium, Switzerland, Germany Denmark, Spain, Finland, France, United Kingdom, Greece, Hong Kong, Ireland, Israel, Italy, Japan, Netherlands, Norway, New Zealand, Portugal, Sweden, and Turkey.","Z-1475-2013","Class II","SlingBar Wide 670. Designed to meet the needs for lifting humans. ","Product # 3156012, 3156017 ",".","412","Retrospective review found 4 sling bars that may present a potential for impalement if a patient, caregiver or bystander were to fall onto the hooks based on a simulated test method. In effort to eliminate any risk of injury, Hill-Rom is requesting products be removed from field use and replaced with an updated design.",4/30/2013,"04/30/2013",6/12/2013,"06/12/2013"
"Devices",64550,"Ongoing","Hill-Rom, Inc.","Batesville","IN","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution-USA (nationwide) including the states of AZ, CA, CO, FL, IL, IN, KS, LA, MA, MI, MN, MO, NC, NH, NJ, NV, OH, OK, PA, SC, TN, UT, WA, and WI, and the countries of Canada, Australia, Austria, Belgium, Switzerland, Germany Denmark, Spain, Finland, France, United Kingdom, Greece, Hong Kong, Ireland, Israel, Italy, Japan, Netherlands, Norway, New Zealand, Portugal, Sweden, and Turkey.","Z-1473-2013","Class II","SlingBar 350. Designed to meet the needs for lifting humans. ","3156015, 3156002, 3156008' 3156004 ",".","3556","Retrospective review found 4 sling bars that may present a potential for impalement if a patient, caregiver or bystander were to fall onto the hooks based on a simulated test method. In effort to eliminate any risk of injury, Hill-Rom is requesting products be removed from field use and replaced with an updated design.",4/30/2013,"04/30/2013",6/12/2013,"06/12/2013"
"Devices",64550,"Ongoing","Hill-Rom, Inc.","Batesville","IN","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution-USA (nationwide) including the states of AZ, CA, CO, FL, IL, IN, KS, LA, MA, MI, MN, MO, NC, NH, NJ, NV, OH, OK, PA, SC, TN, UT, WA, and WI, and the countries of Canada, Australia, Austria, Belgium, Switzerland, Germany Denmark, Spain, Finland, France, United Kingdom, Greece, Hong Kong, Ireland, Israel, Italy, Japan, Netherlands, Norway, New Zealand, Portugal, Sweden, and Turkey.","Z-1476-2013","Class II","SlingBar Standard. Designed to meet the needs for lifting humans. ","Product #3156011",".","726","Retrospective review found 4 sling bars that may present a potential for impalement if a patient, caregiver or bystander were to fall onto the hooks based on a simulated test method. In effort to eliminate any risk of injury, Hill-Rom is requesting products be removed from field use and replaced with an updated design.",4/30/2013,"04/30/2013",6/12/2013,"06/12/2013"
"Devices",64550,"Ongoing","Hill-Rom, Inc.","Batesville","IN","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution-USA (nationwide) including the states of AZ, CA, CO, FL, IL, IN, KS, LA, MA, MI, MN, MO, NC, NH, NJ, NV, OH, OK, PA, SC, TN, UT, WA, and WI, and the countries of Canada, Australia, Austria, Belgium, Switzerland, Germany Denmark, Spain, Finland, France, United Kingdom, Greece, Hong Kong, Ireland, Israel, Italy, Japan, Netherlands, Norway, New Zealand, Portugal, Sweden, and Turkey.","Z-1474-2013","Class II","SlingBar 360. Designed to meet the needs for lifting humans. ","Product # 3156013",".","16","Retrospective review found 4 sling bars that may present a potential for impalement if a patient, caregiver or bystander were to fall onto the hooks based on a simulated test method. In effort to eliminate any risk of injury, Hill-Rom is requesting products be removed from field use and replaced with an updated design.",4/30/2013,"04/30/2013",6/12/2013,"06/12/2013"
"Veterinary",64551,"Terminated","Diggin Your Dog, LLC","Reno","NV","US","Voluntary: Firm Initiated","Telephone","NV and CO","V-208-2013","Class I","Diggin Your Dog Strippin Chicks; USA Chicken Charki Strips for Dogs 100% Grown, Raised, Harvested in USA. Net Wt. 5 oz. Ingredients: Chicken, Vitamin E Supplement. UPC: 6-09788-82324-7 Diggin Your Dog USA, Reno, NV","Lot Code # 250322 and USE BY 2-23-14",".","45 cases ( 12 x 5 oz. packages per case)","Colorado Department of Agriculture collected a sample of Diggin Your Dog Brand Strippin Chicks at retail and had a positive result for Salmonella.",2/27/2013,"02/27/2013",6/19/2013,"06/19/2013"
"Biologics",64552,"Terminated","Blood Bank Of Hawaii","Honolulu","HI","US","Voluntary: Firm Initiated","Letter","Hawaii","B-1480-13","Class II","Red Blood Cells","W088412502915; ",,"1","Blood product, collected from a donor who traveled to an area considered endemic for malaria, was distributed.",2/20/2013,"02/20/2013",6/26/2013,"06/26/2013"
"Biologics",64553,"Terminated","South Bend Medical Foundation, Inc.","South Bend","IN","US","Voluntary: Firm Initiated","Letter","Indiana","B-1451-13","Class II","Red Blood Cells Leukocytes Reduced","W045212038732; ",,"1","Blood products, collected from a donor who was at risk for variant Creutzfeldt-Jakob disease (vCJD), were distributed.",2/13/2013,"02/13/2013",6/26/2013,"06/26/2013"
"Biologics",64553,"Terminated","South Bend Medical Foundation, Inc.","South Bend","IN","US","Voluntary: Firm Initiated","Letter","Indiana","B-1452-13","Class II","Plasma Frozen within 24 hours (FP24)","W045212038732; ",,"1","Blood products, collected from a donor who was at risk for variant Creutzfeldt-Jakob disease (vCJD), were distributed.",2/13/2013,"02/13/2013",6/26/2013,"06/26/2013"
"Biologics",64554,"Terminated","Delta Blood Bank","Stockton","CA","US","Voluntary: Firm Initiated","Letter","CA, IN","B-2040-13","Class II","Red Blood Cells Leukocytes Reduced","W128712240529",".","1 unit","Blood products, collected from a donor who received a piercing within 12 months of donation, were distributed.",3/8/2013,"03/08/2013",8/14/2013,"08/14/2013"
"Food",64555,"Ongoing","Riggio Dist Co","Detriot","MI","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Distributor and retail stores in Illinois and Michgan","F-1140-2013","Class II","Glory Foods Mixed Greens, Verduras Mixtas 16 oz ","Lot 171853 UPC 3639320605 Use By 3/5/13",,"2200 bags","Product has the potential to be contaminatedwith Listeria monocytogenes, an organism which can cause serious and sometimes fatal infections in young children, frail or elderly people, and others with weakened immune systems. Routine testing by the Michigan Department of Agriculture revealed the presence of Listeria Monocytogenes in a single 16 ounce package of ''Mixed Blend'' Greens.",3/7/2013,"03/07/2013",3/20/2013,"03/20/2013"
"Food",64558,"Ongoing","Chu Minh Corp ","Seattle","WA","US","Voluntary: Firm Initiated","Telephone","Products are distributed to one sole consignee in Washington and sold directly to walk-in consumers from the production site.","F-2178-2013","Class II","CHU MINH TOFU Fried Soybean Cake (Tofu), net weight 12 oz. The UPC is 8 18140 00003 9. The product is labeled in parts: ''***CHUMINH TOFU***Fried Soybean Cake (Tofu)***Ingredients: Soybean, Water, Calcium Sulfate, Corn Oil***NET WT. 12 OZ***Perishable***Keep Refrigerated***CHUMINH TOFU INCORPORATION***6754 Martin Luther King Way S. Seattle, WA 98118***(206) 723-4273***''.","expiration date: 3/14 and 3/15",".","unknown","All fresh tofu and fried tofu products are recalled because they were made in a facility with no available hot water.",3/7/2013,"03/07/2013",4/10/2013,"04/10/2013"
"Food",64558,"Ongoing","Chu Minh Corp ","Seattle","WA","US","Voluntary: Firm Initiated","Telephone","Products are distributed to one sole consignee in Washington and sold directly to walk-in consumers from the production site.","F-2177-2013","Class II","CHU MINH TOFU Fresh Soybean Cake (Tofu), net weight 16 oz. The UPC is 8 18140 00002 2. The product is labeled in parts: ''***CHUMINH TOFU***Fresh Soybean Cake (Tofu)***Ingredients: Soybean, Water, Calcium Sulfate***NET WT. 16 OZ***Perishable***Keep Refrigerated***CHUMINH TOFU INCORPORATION***6754 Martin Luther King Way S. Seattle, WA 98118***(206) 723-4273***''.","expiration date: 3/14 and 3/15",".","unknown","All fresh tofu and fried tofu products are recalled because they were made in a facility with no available hot water.",3/7/2013,"03/07/2013",4/10/2013,"04/10/2013"
"Devices",64559,"Ongoing","Kerr/Pentron, DBA Kerr Corporation and Pentron Clinical","Orange","CA","US","Voluntary: Firm Initiated","Letter","Worldwide distribution: USA (nationwide) and countries of: Australia, Canada, Belgium, Czech Republic, France, Great Britain, Poland, Albania, Austria, Bulgaria, Switzerland, Cyprus, Germany, Denmark, Estonia, Spain, Finland, Croatia, Hungary, Ireland, ITtaly Luxembourg, Latvia, Netherlands, Norway, Portugal, Romania, Serbia (Republic of Serbia), Sweden, Slovenia, Turkey, Ukraine, United Arab Emirates, Congo, The Democratic Republic of the (formerly Zaire), Kazakhstan, Lebanon, Russian Federation, South Africa, Mexico, Thailand, Brazil, China, Hong Kong, Israel, India, Japan, Malaysia, Panama, Singapore, Viet Nam.","Z-1076-2013","Class II","Kerr Maxcem Elite, self-etch/self-adhesive resin cement; Intro Kit Part No. 34417; DMC 0446 Rev 0. Used for cementation of all indirect restorations.","34417 KIT- MAXCEM ELITE INTRO 2-46620524672087 4694484 4698107 4710901 4719936 4725775 4725776 34418 KIT - MAXCEM ELITE BULK-4706738 4656479 4656480 4666810 4666811 4666813 4668612 4709788 4710900 4712887 4725780 4729919 4734053 4744195 SYRINGE LOT NUMBERS 34417 & 34418 SYRINGE- MAXCEM ELITE CLEAR Individually affected syringes within Kits listed above-4663716 4663717 4690551 4690552 4704821 4728088 4741721 33872 REFILL- MAXCEM ELITE CLEAR-4664825 4669840 4669841 4672089 4676812 4676815 4678974 4678975 4690548 4690549 4690550 4702597 4710904 4710905 4718097 4720553 4720555 4720558 4720560 4720562 4720563 4720564 4720565 33873 REFILL- MAXCEM ELITE WHITE-4681749 4699954 4704804 4720556 4720567 4720568 4720569 4720573 4720574 4720575 33874 -REFILL- MAXCEM ELITE WHITE OPAQUE-4720576 4720577 4720578 4720579 4720580 33875-REFILL- MAXCEM ELITE YELLOW -4652147 4696832 4720198 33876 -REFILL- MAXCEM ELITE BROWN -4710907 4725879 34055 MAXCEM ELITE STANDARD KIT-4620128 4656894 4680372 4709328 4728932 4732387 4733719 4735545 4748933 4759314 34056 -MAXCEM ELITE VALUE KIT-4719214 4759315 4698814 34057 -MAXCEM ELITE MINI KIT-4709329 4714775 4728934 4732388 4756503 34058 MAXCEM ELITE REFILL CLEAR-4628189 4728840 4728844 4728935 4730842 4732144 4735257 4735546 4748934 4756504 34059 -MAXCEM ELITE REFILL WHITE-4705713 4728936 4745082 4756505 34060 MAXCEM ELITE REFILL WHITE OPAQUE-4719215 4735547 4768408 34061 MAXCEM ELITE REFILL YELLOW -4700948 4705714 4728937 4756506 4768409 34062 MAXCEM ELITE REFILL BROWN -4709330 4738886 4749728 MAXCEM ELITE CLEAR FILLED SYRINGE-4679149 4679150 4681816 4681817 4685882 4685882 4694026 4694026 4694028 4694030 4708393 4708393 4717716 4721155 4733694 4741330 4756672 4756673 4766817 MAXCEM ELITE WHITE OPAQUE FILLED SYRINGE -4684879 4685879 4733678 MAXCEM ELITE YELLOW FILLED SYRINGE -4689433 4689433 4693134 4693134 4717719 4743042 4770898 MAXCEM ELITE BROWN FILLED SYRINGE -4708392",,"40,819 kit and syringe units","Kerr Corporation is initiating this recall because raw material used to produce the Maxcem Elite is causing the material to prematurely polymerize in the syringe. The product could be difficult to extrude or demonstrate a shorter work-time as the material may prematurely set prior to placing restorations on the tooth or core build-up. As a result, the restoration may not be seated properly.",2/22/2013,"02/22/2013",4/17/2013,"04/17/2013"
"Biologics",64560,"Ongoing","Blood Bank Computer Systems, Inc","Auburn","WA","US","Voluntary: Firm Initiated","E-Mail","Software was distributed nationwide","B-1344-13","Class II","Blood bank software Primary Application with Model numbers 5.4.0; 5.4.0.1; 5.4.0.2; and 5.4.1","Model numbers 5.4.0; 5.4.0.1; 5.4.0.2; and 5.4.1 Serial numbers: 0001846, 0001847, 0001848, 0001849, 0001850, 0001851, 0001852, 0001853, 0001854, 0001855, 0001856, 0001857, 0001858, 0001859, 0001860, 0001861, 0001862, 0001863, 0001864, 0001865, 0001866, 0001867, 0001868, 0001869, 0001870, 0001871, 0001872, 0001873, 0001874, 0001875, 0001876, 0001891, 0001892, 0001893, 0001894, 0001895, 0001896, 0001897, 0001898, 0001899, 0001900, 0001901, 0001902, 0001903, 0001904, 0001905, 0001906, 0001907, 0001908, 0001909, 0001910, 0001911, 0001912, 0001913, 0001914, 0001915, 0001916, 0001917, 0001918, 0001919, 0001920, 0001921, 0002017, 0002018, 0002029, 0002030, 0002031, 0002032, 0002033, 0002034, 0002035, 0002036, 0002037, 0002038, 0002039, 0002040, 0002041, 0002042, 0002043, 0002044, 0002045, 0002046, 0002047, 0002048, 0002049, 0002050, 0002051, 0002052, 0002053, 0002054, 0002055, 0002056, 0002057, 0002058, 0002059, 0002060, 0002061, 0002062, 0002063, 0002064, 0002065, 0002066, 0002067, 0002068, 0002069, 0002070, 0002071, 0002072, 0002073, 0002074, 0002075, 0002076, 0002077, 0002078, 0002079, 0002080, 0002081, 0002082, 0002083, 0002084, 0002085, 0002086, 0002087, and 0002088",,"4","Blood Bank Software, with a defect or glitch, was distributed. ",11/1/2012,"11/01/2012",4/17/2013,"04/17/2013"
"Biologics",64561,"Ongoing","Blood Bank Computer Systems, Inc","Auburn","WA","US","Voluntary: Firm Initiated","E-Mail","Software was distributed nationwide.","B-1345-13","Class II","Blood bank software Primary Application with Model numbers 5.4.0; 5.4.0.1; 5.4.0.2; and 5.4.1","Model Numbers 5.4.0; 5.4.0.1; 5.4.0.2; and 5.4.1 Serial numbers: 0001846, 0001847, 0001848, 0001849, 0001850, 0001851, 0001852, 0001853, 0001854, 0001855, 0001856, 0001857, 0001858, 0001859, 0001860, 0001861, 0001862, 0001863, 0001864, 0001865, 0001866, 0001867, 0001868, 0001869, 0001870, 0001871, 0001872, 0001873, 0001874, 0001875, 0001876, 0001891, 0001892, 0001893, 0001894, 0001895, 0001896, 0001897, 0001898, 0001899, 0001900, 0001901, 0001902, 0001903, 0001904, 0001905, 0001906, 0001907, 0001908, 0001909, 0001910, 0001911, 0001912, 0001913, 0001914, 0001915, 0001916, 0001917, 0001918, 0001919, 0001920, 0001921, 0002017, 0002018, 0002029, 0002030, 0002031, 0002032, 0002033, 0002034, 0002035, 0002036, 0002037, 0002038, 0002039, 0002040, 0002041, 0002042, 0002043, 0002044, 0002045, 0002046, 0002047, 0002048, 0002049, 0002050, 0002051, 0002052, 0002053, 0002054, 0002055, 0002056, 0002057, 0002058, 0002059, 0002060, 0002061, 0002062, 0002063, 0002064, 0002065, 0002066, 0002067, 0002068, 0002069, 0002070, 0002071, 0002072, 0002073, 0002074, 0002075, 0002076, 0002077, 0002078, 0002079, 0002080, 0002081, 0002082, 0002083, 0002084, 0002085, 0002086, 0002087, and 0002088. ",,"4","Blood Bank Software, with a defect or glitch, was distributed. ",12/5/2012,"12/05/2012",4/17/2013,"04/17/2013"
"Biologics",64562,"Ongoing","Blood Bank Computer Systems, Inc","Auburn","WA","US","Voluntary: Firm Initiated","E-Mail","Software distributed nationwide.","B-1346-13","Class II","Blood bank software Primary Application 5.4.0.1; 5.4.0.2; and 5.4.1","Model numbers: 5.4.0.1; 5.4.0.2; and 5.4.1 Serial numbers: 0001891, 0001892, 0001893, 0001894, 0001895, 0001896, 0001897, 0001898, 0001899, 0001900, 0001901, 0001902, 0001903, 0001904, 0001905, 0001906, 0001907, 0001908, 0001909, 0001910, 0001911, 0001912, 0001913, 0001914, 0001915, 0001916, 0001917, 0001918, 0001919, 0001920, 0001921, 0002018, 0002029, 0002030, 0002031, 0002032, 0002033, 0002034, 0002035, 0002036, 0002037, 0002038, 0002039, 0002040, 0002041, 0002042, 0002043, 0002044, 0002045, 0002046, 0002047, 0002048, 0002049, 0002050, 0002051, 0002052, 0002053, 0002054, 0002055, 0002056, 0002057, 0002058, 0002059, 0002060, 0002061, 0002062, 0002063, 0002064, 0002065, 0002066, 0002067, 0002068, 0002069, 0002070, 0002071, 0002072, 0002073, 0002074, 0002075, 0002076, 0002077, 0002078, 0002079, 0002080, 0002081, 0002082, 0002083, 0002084, 0002085, 0002086, 0002087, and 0002088.",,"3","Blood Bank Software with a defect or glitch, was distributed. ",2/8/2013,"02/08/2013",4/17/2013,"04/17/2013"
"Biologics",64563,"Ongoing","Blood Bank Computer Systems, Inc","Auburn","WA","US","Voluntary: Firm Initiated","E-Mail","Software was distributed nationwide.","B-1347-13","Class II","Blood bank software Primary Application 5.4.0.2 and 5.4.1","Model numbers: 5.4.02 and 5.4.1 Serial numbers: 0002029, 0002030, 0002031, 0002032, 0002033, 0002034, 0002035, 0002036, 0002037, 0002038, 0002039, 0002040, 0002041, 0002042, 0002043, 0002044, 0002045, 0002046, 0002047, 0002048, 0002049, 0002050, 0002051, 0002052, 0002053, 0002054, 0002055, 0002056, 0002057, 0002058, 0002059, 0002060, 0002061, 0002062, 0002063, 0002064, 0002065, 0002066, 0002067, 0002068, 0002069, 0002070, 0002071, 0002072, 0002073, 0002074, 0002075, 0002076, 0002077, 0002078, 0002079, 0002080, 0002081, 0002082, 0002083, 0002084, 0002085, 0002086, 0002087, and 0002088. ",,"2","Blood Bank Software, with a defect or glitch, was distributed. ",1/17/2013,"01/17/2013",4/17/2013,"04/17/2013"
"Biologics",64564,"Terminated","Central California Blood Center","Fresno","CA","US","Voluntary: Firm Initiated","E-Mail","California","B-1453-13","Class II","Red Blood Cells Leukocytes Reduced","W115912054763; ",,"1","Blood product, which was collected from a donor who traveled to a malarial endemic area, was distributed.",2/4/2013,"02/04/2013",6/26/2013,"06/26/2013"
"Biologics",64565,"Terminated","LifeShare Blood Centers","Shreveport","LA","US","Voluntary: Firm Initiated","FAX","Arkansas","B-1454-13","Class II","Red Blood Cells Leukocytes Reduced","W036513010376; ",,"1","Blood product, collected from a donor considered to be at increased risk for variant Creutzfeldt-Jakob Disease (vCJD), was distributed. ",2/6/2013,"02/06/2013",6/26/2013,"06/26/2013"
"Biologics",64566,"Terminated","DCI Biologicals Lubbock, LLC","Lubbock","TX","US","Voluntary: Firm Initiated","FAX","United Kingdom","B-1455-13","Class II","Source Plasma","LU0573741; LU0574883; ",,"2","Blood products, which were not quarantined subsequent to receiving information regarding post donation information, were distributed.",10/9/2012,"10/09/2012",6/26/2013,"06/26/2013"
"Biologics",64567,"Terminated","Florida's Blood Centers, Inc.","Orlando","FL","US","Voluntary: Firm Initiated","Letter","Florida; Washington","B-1456-13","Class II","Fresh Frozen Plasma","9765437; ",,"1","Blood products, collected from a donor who was previously deferred, were distributed.",1/25/2013,"01/25/2013",6/26/2013,"06/26/2013"
"Biologics",64567,"Terminated","Florida's Blood Centers, Inc.","Orlando","FL","US","Voluntary: Firm Initiated","Letter","Florida; Washington","B-1458-13","Class II","Red Blood Cells Leukocytes Reduced","9765437; ",,"1","Blood products, collected from a donor who was previously deferred, were distributed.",1/25/2013,"01/25/2013",6/26/2013,"06/26/2013"
"Biologics",64567,"Terminated","Florida's Blood Centers, Inc.","Orlando","FL","US","Voluntary: Firm Initiated","Letter","Florida; Washington","B-1457-13","Class II","Platelets Irradiated","9765437; ",,"1","Blood products, collected from a donor who was previously deferred, were distributed.",1/25/2013,"01/25/2013",6/26/2013,"06/26/2013"
"Devices",64568,"Ongoing","Instrumentation Industries Inc","Bethel Park","PA","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution - USA including AK, AL, AZ, CA, CO, CT, DC, FL, GA, IA, ID, IL, IN, KS, KY, LA, MA, MD, MI, MN, MO, MS, MT, NC, ND, NH, NJ, NV, NY, OH, OK, OR, PA, PR, SC, SD, TN, TX, UT, VA, VT, WA, WI and WV. Shipped internationally to Canada, Ireland, Hong Kong, the Netherlands, New Zealand, and Thailand.","Z-1125-2013","Class II","Instrumentation Industries BE183-SU and BE 183 SU-12 Manual Jet Ventilators; BE 183-SUR and BE 183 SUR-12 Manual Jet Ventilators with Regulator and Gauge; BE 183-2 4 ft. Small Bore Tubing Assembly w/Inline Filter; and BE 183-R Regulator The BE 183-SUR and BE 183-SU Manual Jet Ventilators are designed to provide transtracheal ventilation in specific emergency situations of upper airway obstructions. ","BE 183-2 -- lot numbers P0911307, P1109307, P1117907, P1210807, P1216107, P0112208, P0203508, P0208308, P0220008, P0313608, P0503608, P0510108, P0712408, P0816308, P0911708, P1008408, P0115009, P0203009, P0313109, P0603709, P0619009, P0806309, P0903509, P0905109, P0912309, P1005709, P1107809, P1205709, P1214309, P0111410, P0210810, P0212510, P0300210, P0314310, P0400710, P0404510, P0701210, P0705410, P0715010, P0816310, P0715010R10, P0705410R10, P1001810, P1011610, P1114810, P1204810, P1207310, P0109811, P0211311, P0404611, P0504911, P0603911, P0706511, P0801811, P0811811, P0818511, P0900611, P0908411, P0917111, P1008111, P1012211, P1113911, P1207111, P0107712, P0118212, P0211712, P0308512, P0409012, P0412912, P0802012, and P0813612; BE 183-R -- P0904007, P1015407, P1118107, P1209207, P0205608, P0208208, P0415408, P0509608, P0503008, P0517408R, P1215508, P0200709, P0308109, P0614909, P0712009, P0806409, P0903309, P1101909, P1101909R10, P0303710, P0409910, P0615710, P0710710, P0714510, P0814310, P0907010, P1214710, P0208711, P0208711R11, P1214710R11, P0716411, P0718111, P0807511, P0812211, P0816111, P0819511, P0914111, P1000511, P1015011, P1217911, P0117112, P0211312, P0313612, P0605312, P0709612, and P0807812; BE183-SU -- P0914607, P1015607, P1016907, P1119007, P1201807, P1211307, P0108808, P0112408, P0203008, P0208608, P0306908, P0313508, P0404908, P0510008, P0708808, P0806508, P0915908, P1020008, P1104508, P1109108, P1211608, P0102809, P0203109, P0208109, P0214609, P0302209, P0504909, P0603609, P0617209, P0618909, P0703509, P0804609, P0812609, P1005209, P1110009, P1221709, P0104510, P0108110, P0307110, P0411910, P0603510, P0616210, P0813510, P0912310, P1000910, P1017410, P0111111, P0207611, P0209411, P0216411, P0300611, P0309411, P0515711, P0619111, P0707411, P0717311, P0804011, P0809611, P0815311, P0901611, P0905011, P0915611, P1014511, P1103511, P1112811, P1116411, P1201911, P1213511, P1216511, P0103312, P0106212, P0114112, P0207712, P0211112, P0216312, P0320512, P0402512, P0408912, P0416912, P05092",".","2998","Firm initiated an update to Directions for Use necessitating replacement of previously distributed Directions for Use.",9/7/2012,"09/07/2012",4/24/2013,"04/24/2013"
"Devices",64569,"Ongoing","Zimmer, Inc.","Warsaw","IN","US","Voluntary: Firm Initiated","Letter","Nationwide Distribution including the states of AZ, CO, DE, FL, ID, LMA, MI, NH, NJ, NM, PA, RI, TX, and VA.","Z-1045-2013","Class II","Zimmer NexPosure, retractor portals of the NexPosure MIS Access System, Part Numbers or REF numbers: N1830R80-100, N1830R80-090 , N1830R80-080 , N1830R80-070 , N1830R80-060, N1830R50-100, N1830R50-090, N1830R50-080, N1830R50-070, N1830R50-060, N1830L80-100, N1830L80-090, N1830L80-080, N1830L80-070, N1830L80-060, N1830L50-100, N1830L50-090, N1830L50-080, N1830L50-070, N1830L50-060, N182450-085, N182450-075, N182450-065, N182450-055, N182450-045. Retractor access system that allows placement of posterior spinal fixation implants. ","Lot Number61225572 61664689 61664689 61657007 61657015 61657015 61267745 61267745 61267750 61267750 61267753 61267753 61657016 61657016 61801814 61895685 61657017 61657018 61657018 61267756 61267756 61267759 61267759 61267760 61267760 61267761 61267761 61267761 61873348 61657019 61657019 61657031 61657031 ",".","58","Possibility that the inner pouch may be compromised. The product is packaged in two pouches - a sterile inner pouch within an external pouch. NexPosure Retractors contained in a breached inner pouch have an increased risk of contamination (i.e.; loss of product sterility) if proper aseptic technique is not followed when transferring the inner package into the sterile field. Patient infection may occur due to loss of product sterility. ",2/8/2013,"02/08/2013",4/10/2013,"04/10/2013"
"Devices",64570,"Ongoing","Siemens Healthcare Diagnostics, Inc.","Newark","DE","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution.","Z-1046-2013","Class III","Siemens Dimension(R) EXL(TM) LM (Siemens Material Number 10486890). Intended to measure a variety of analytes in human body fluids.","Siemens Material Number 10486890",".","2207 total","Through investigation of customer complaints, Siemens Healthcare Diagnostics has confirmed an increase in System Check failures due to high System Check LOCI results. Upon further investigation, Siemens has determined that many of these errors are due to the current limit set for System Check LOCI results. The errors have no impact on results, but they may cause customer inconvenience. Siemens has validated a new limit for System Check LOCI results that can be used with Software Version 10.0 in order to resolve the issue.",2/27/2013,"02/27/2013",4/10/2013,"04/10/2013"
"Devices",64570,"Ongoing","Siemens Healthcare Diagnostics, Inc.","Newark","DE","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution.","Z-1048-2013","Class III","Siemens Dimension(R) EXL(TM) 200 (Siemens Material Number 10636929). Intended to measure a variety of analytes in human body fluids.","Siemens Material Number 10636929",".","2207 total","Through investigation of customer complaints, Siemens Healthcare Diagnostics has confirmed an increase in System Check failures due to high System Check LOCI results. Upon further investigation, Siemens has determined that many of these errors are due to the current limit set for System Check LOCI results. The errors have no impact on results, but they may cause customer inconvenience. Siemens has validated a new limit for System Check LOCI results that can be used with Software Version 10.0 in order to resolve the issue.",2/27/2013,"02/27/2013",4/10/2013,"04/10/2013"
"Devices",64570,"Ongoing","Siemens Healthcare Diagnostics, Inc.","Newark","DE","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution.","Z-1047-2013","Class III","Siemens Dimension(R) EXL(TM) LM STM (Siemens Material Number 106393377). Intended to measure a variety of analytes in human body fluids.","Siemens Material Number 106393377",".","2207 total","Through investigation of customer complaints, Siemens Healthcare Diagnostics has confirmed an increase in System Check failures due to high System Check LOCI results. Upon further investigation, Siemens has determined that many of these errors are due to the current limit set for System Check LOCI results. The errors have no impact on results, but they may cause customer inconvenience. Siemens has validated a new limit for System Check LOCI results that can be used with Software Version 10.0 in order to resolve the issue.",2/27/2013,"02/27/2013",4/10/2013,"04/10/2013"
"Drugs",64571,"Completed","Green Planet Inc","Riverside","CA","US","Voluntary: Firm Initiated","Press Release","Nationwide.","D-828-2013","Class I","Night Bullet Capsules, supplied in 1 count packets, produced by Green Planet Inc, Riverside, CA ","Lot# B43N032, Exp 10/15",,"429,619 capsules","Marketed Without an Approved NDA/ANDA; product contains analogues of sildenafil and tadalafil which are active pharmaceutical ingredients in FDA-approved drugs used to treat erectile dysfunction (ED) making this product an unapproved new drug. ",3/11/2013,"03/11/2013",8/7/2013,"08/07/2013"
"Food",64572,"Ongoing","La Preferida Inc","Chicago","IL","US","Voluntary: Firm Initiated","Press Release","Nationwide (AL, CA, CO, FL, GA, IA, IL, IN, MA, MI, MN, MO, NE, OH, PA, TN, TX, and WI)","F-1323-2013","Class II","Metal cans; labeled as containing 29 oz of pinto beans packed in water and salt","UPC: 071524020034; Producty Code: PINTO LP; Best By Date: 01/03/2015; Lot Code: 3003; Time Code: All Time Codes",".","4,734 cases (57,040 cans)","Some cans may not have been fully processed which could result in product contamination by spoilage organisms or by pathogens, which could lead to illness if consumed.",3/9/2013,"03/09/2013",4/24/2013,"04/24/2013"
"Biologics",64573,"Terminated","Rhode Island Blood Center","Providence","RI","US","Voluntary: Firm Initiated","Telephone","New York","B-1475-13","Class II","Fresh Frozen Plasma","W051712639896; ",".","1 product","Blood product, collected from a donor with risk factors for vCJD, was distributed. ",2/15/2013,"02/15/2013",6/12/2013,"06/12/2013"
"Biologics",64574,"Terminated","DCI Biologicals Carbondale, LLC","Carbondale","IL","US","Voluntary: Firm Initiated","FAX","California","B-1493-13","Class II","Source Plasma","CD0371015; CD0371217; CD0371723; CD0371909; ",".","4","Blood products, collected from a donor who had been incarcerated, were distributed. ",1/4/2013,"01/04/2013",6/19/2013,"06/19/2013"
"Biologics",64575,"Terminated","Hoxworth Blood Center UC Medical Center","Cincinnati","OH","US","Voluntary: Firm Initiated","Letter","Ohio","B-1476-13","Class II","Red Blood Cells Leukocytes Reduced","W037711189379; ",".","1","Blood product, collected from a donor who reported travel to a malarial endemic area, was distributed.",12/28/2012,"12/28/2012",6/19/2013,"06/19/2013"
"Biologics",64576,"Ongoing","Micro Typing Systems, Inc.","Pompano Beach","FL","US","Voluntary: Firm Initiated","Letter","Canada; Multiple U.S. States","B-1236-13","Class III","MTS Anti-IgG Cards (Catalog # MTS 084024)","08071200134 , 09061200105, 09061200107, 09061200109, 09061200111, 09061200115, 09061200119, 09061200121, 09061200124, 09061200128, 09061200129, 10041200104, 10041200111, 10041200113, 10041200115, 10041200119",".","16","In-vitro diagnostic test cards, associated with complaints of an incomplete foil seal for specific lots of ID-Micro Typing System Gel Cards, were distributed. ",11/5/2012,"11/05/2012",5/1/2013,"05/01/2013"
"Biologics",64576,"Ongoing","Micro Typing Systems, Inc.","Pompano Beach","FL","US","Voluntary: Firm Initiated","Letter","Canada; Multiple U.S. States","B-1237-13","Class II","MTS A/B/D Monoclonal and Reverse Grouping Card (Product Code MTS080515)","09131203710",".","1","In-vitro diagnostic test cards, associated with complaints of an incomplete foil seal for specific lots of ID-Micro Typing System Gel Cards, were distributed. ",11/5/2012,"11/05/2012",5/1/2013,"05/01/2013"
"Devices",64577,"Ongoing","Ortho-Clinical Diagnostics","Rochester","NY","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution- USA (nationwide) including Puerto Rico and countries of: Australia, Brazil, Canada, Chile, China, Colombia, England, France, Germany, India, Italy, Japan, Republic of Panama, Singapore, Spain, and Venezuela.","Z-1107-2013","Class II","VITROS 4600 Chemistry System (VITROS 5,1 FS System family member), Product Code 6802445. Intended for use in the measurement of a variety of chemistry analytes. ","Serial Numbers 46000108 through 46000217",".","USA: 58 units, Foreign: 103 units","Ortho-Clinical Diagnostics, Inc. (OCD) determined that extension springs on some VITROS Systems may be out of its manufacturing specifications. Extension springs are part of the slide alignment guide assembly. During an internal evaluation in its manufacturing facility, it was discovered that an extension spring had insufficient force. If the extension spring does not provide sufficient force, MicroSlides may not be properly positioned within the MicroSlide incubator which has the potential to cause imprecise results. Extension springs are just one component in the slide alignment assembly. OCD's evaluation determined that the probability of an out of specification extension spring alone adversely affecting results is unlikely. ",2/7/2013,"02/07/2013",4/24/2013,"04/24/2013"
"Devices",64577,"Ongoing","Ortho-Clinical Diagnostics","Rochester","NY","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution- USA (nationwide) including Puerto Rico and countries of: Australia, Brazil, Canada, Chile, China, Colombia, England, France, Germany, India, Italy, Japan, Republic of Panama, Singapore, Spain, and Venezuela.","Z-1106-2013","Class II","VITROS 5,1 FS Chemistry System, Product Code 6801375 and VITROS 5,1 FS Chemistry System Refurbished, Product Code 6801890. Intended for use in the measurement of a variety of chemistry analytes. ","VITROS 5,1 FS Chemistry System Serial Numbers: 34000119 through 34002273; VITROS 5,1 FS Chemistry System Refurbished Serial Numbers: 34000133, 34001240, 34000193, 34001243, 34000212, 34001248, 34000316, 34001251, 34000318, 34001274, 34000337, 34001297, 34000360, 34001311, 34000420, 34001317, 34000451, 34001345, 34000478, 34001378, 34000495, 34001389, 34000497, 34001390, 34000529, 34001396, 34000538, 34001422, 34000552, 34001472, 34000557, 34001504, 34000596, 34001569, 34000601, 34001572, 34000631, 34001589, 34000642, 34001610, 34000799, 34001633, 34000805, 34001668, 34000833, 34001809, 34000851, 34001840, 34000893, 34001850, 34000947, 34001897, 34001172, 34001218 ",".","VITROS 5,1 FS: USA: 670 units, Foreign: 1249 units; VITROS 5,1 FS Refurbished: USA: 52 units, Foreign: 2 units ","Ortho-Clinical Diagnostics, Inc. (OCD) determined that extension springs on some VITROS Systems may be out of its manufacturing specifications. Extension springs are part of the slide alignment guide assembly. During an internal evaluation in its manufacturing facility, it was discovered that an extension spring had insufficient force. If the extension spring does not provide sufficient force, MicroSlides may not be properly positioned within the MicroSlide incubator which has the potential to cause imprecise results. Extension springs are just one component in the slide alignment assembly. OCD's evaluation determined that the probability of an out of specification extension spring alone adversely affecting results is unlikely. ",2/7/2013,"02/07/2013",4/24/2013,"04/24/2013"
"Devices",64577,"Ongoing","Ortho-Clinical Diagnostics","Rochester","NY","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution- USA (nationwide) including Puerto Rico and countries of: Australia, Brazil, Canada, Chile, China, Colombia, England, France, Germany, India, Italy, Japan, Republic of Panama, Singapore, Spain, and Venezuela.","Z-1108-2013","Class II","VITROS 5600 Integrated System, Product Code 6802413. Intended for use in the measurement of a variety of chemistry analytes. ","Serial Numbers 56000118 through 56001583",".","USA: 775 units, Foreign: 800 units","Ortho-Clinical Diagnostics, Inc. (OCD) determined that extension springs on some VITROS Systems may be out of its manufacturing specifications. Extension springs are part of the slide alignment guide assembly. During an internal evaluation in its manufacturing facility, it was discovered that an extension spring had insufficient force. If the extension spring does not provide sufficient force, MicroSlides may not be properly positioned within the MicroSlide incubator which has the potential to cause imprecise results. Extension springs are just one component in the slide alignment assembly. OCD's evaluation determined that the probability of an out of specification extension spring alone adversely affecting results is unlikely. ",2/7/2013,"02/07/2013",4/24/2013,"04/24/2013"
"Devices",64578,"Ongoing","Spinal Solutions, LLC","Murrieta","CA","US","Voluntary: Firm Initiated","Letter","Nationwide Distribution including NV, WI, MD,and CA.","Z-1157-2013","Class II","APLIF Implants and Instruments, Part Numbers: 184008-10 Anterior Psoas Lumbar 18 x 40 x 08mm - 10degree 184010-10 Anterior Psoas Lumbar 18 x 40 x 10mm - 10degree 184012-10 Anterior Psoas Lumbar 18 x 40 x 12mm - 10degree 184014-10 Anterior Psoas Lumbar 18 x 40 x 14mm - 10degree 184016-10 Anterior Psoas Lumbar 18 x 40 x 16mm - 10degree 184008-00 Anterior Psoas Lumbar 18 x 40 x 08mm - 00degree 184010-00 Anterior Psoas Lumbar 18 x 40 x 10mm - 00degree 184012-00 Anterior Psoas Lumbar 18 x 40 x 12mm - 00degree 184014-00 Anterior Psoas Lumbar 18 x 40 x 14mm - 00degree 184016-00 Anterior Psoas Lumbar 18 x 40 x 16mm - 00degree 184510-08 Anterior Psoas Lumbar 18 x 45 x 08mm - 10degree 184510-10 Anterior Psoas Lumbar 18 x 45 x 10mm - 10degree 184512-10 Anterior Psoas Lumbar 18 x 45 x 12mm - 10degree 184514-10 Anterior Psoas Lumbar 18 x 45 x 14mm - 10degree 184516-10 Anterior Psoas Lumbar 18 x 45 x 16mm - 10degree 184510-00 Anterior Psoas Lumbar 18 x 45 x 10mm - 00degree 184512-00 Anterior Psoas Lumbar 18 x 45 x 12mm - 00degree 184514-00 Anterior Psoas Lumbar 18 x 45 x 14mm - 00degree 184516-00 Anterior Psoas Lumbar 18 x 45 x 16mm - 00degree 185008-10 Anterior Psoas Lumbar 18 x 50 x 08mm - 10degree 185010-10 Anterior Psoas Lumbar 18 x 50 x 10mm - 10degree 185012-10 Anterior Psoas Lumbar 18 x 50 x 12mm - 10degree 185014-10 Anterior Psoas Lumbar 18 x 50 x 14mm - 10degree 185016-10 Anterior Psoas Lumbar 18 x 50 x 16mm - 10degree 185008-00 Anterior Psoas Lumbar 18 x 50 x 08mm - 00degree 185010-00 Anterior Psoas Lumbar 18 x 50 x 10mm - 00degree 185012-00 Anterior Psoas Lumbar 18 x 50 x 12mm - 00degree 185014-00 Anterior Psoas Lumbar 18 x 50 x 14mm - 00degree 185016-00 Anterior Psoas Lumbar 18 x 50 x 16mm - 00degree 185508-10 Anterior Psoas Lumbar 18 x 55 x 08mm - 10degree 185510-10 Anterior Psoas Lumbar 18 x 55 x 10mm - 10degree 185512-10 Anterior Psoas Lumbar 18 x 55 x 12mm - 10degree 185514-10 Anterior Psoas Lumbar 18 x 55 x 14mm - 10degree 185516-10 Anterior Psoas Lumbar 18 x 55 x 16mm -","All lots are subject to this recall.",".","220 units","Spinal Solutions is recalling the APLIF system because it is not supported by adequate testing and documentation to demonstrate that it meets performance or safety standards. These inadequacies might result in product performance failures that could cause patient harm due to implant breakage, movement, or inadequate sterilization.",3/8/2013,"03/08/2013",5/1/2013,"05/01/2013"
"Devices",64579,"Ongoing","Biosense Webster, Inc.","Irwindale","CA","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution - USA (Nationwide) and countries of: DE, NL, CH, FR, GB, DK.","Z-1023-2013","Class II","20-Pole Eco Cable, Catalog #EM-5050-060 Product Usage: The 20-Pole Eco Cable is intended to be used as an interface cable between the LASSO NAV Eco Catheter and CARTO 3 System. ","Impacted serial Numbers: 120, 132, 134,136, 151, 342, 350, 354, 356, 363, 368, 373, 379, 380, 384, 385, 402, 405, 424, 919, 953, 954, 960, 963, 968, 970, 977, 980, 993, 998, 1001, 1123, 1148, 1378, 1596, 1729, 1745, 1747, 1749, 1750, 1751, 1753, 1754, 1758, 1759, 1760, 1761, 1797, 1799, 1802, 1803, 1804, 1805. Lot Numbers: P1210, P1220, P1221, P1231.",,"54 units","Biosense is recalling the 20-Pole Eco Cable because it was incorrectly calibrated. When a catheter is connected to an affected to an affected 20-Pole Eco Cable, the catheter will not be recognized by the impacted 54 cable serial numbers within the field.",3/5/2013,"03/05/2013",4/3/2013,"04/03/2013"
"Devices",64580,"Ongoing","Hill-Rom, Inc.","Batesville","IN","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","USA Nationwide Distribution including the state of Canada","Z-0949-2013","Class II","TotalCare SpO2RT2 bed. Product Usage: Bed, flotation therapy, powered bed may be used in a variety of settings including, but not limited to, acute care, including critical care, step down/progressive care, medical/surgical, high acuity sub-acute care, post anesthesia care unit (PACU), and sections of the emergency department (ED). The TotalCare SpO2RT 2 Bed System is capable of being used with a broad patient population as determined appropriate by the caregiver or institution."," S/N between N230AM1358 & O023AM3687. ",,"309","In certain situations a software problem with the TotalCare SpO2RT 2 bed may occur that can lead to inadvertent loss of sufficient surface cushionpressure to adequately support the patient. This may increase the likelihood of skin irritation for patients at higher risk of developing pressure-related skin conditions. A correction to the software program is currently being developed and tested, and will be released within thirty (30) days.",2/26/2013,"02/26/2013",3/20/2013,"03/20/2013"
"Veterinary",64581,"Ongoing","Schell & Kampeter, Inc.","Meta","MO","US","Voluntary: Firm Initiated","E-Mail","AL, CO, FL, GA, IN, KY, MD, MA, MI, MN, MO, NY, NC, OH, OK, PA, SC, VA, Canada, Costa Rica, Japan, Lebanon, Latvia, Poland, Russia, Sweden, Singapore, Slovenia, Taiwan","V-309-2013","Class I","4health All Life Stages Cat Formula, 5 lb. and 18 lb. bags, Distributed By: Tractor Supply Company, 200 Powell Place, Brentwood, TN 37027. ","Production Codes: NGF0802, Best By: 14-Aug-2013 and 18-Aug-2013.",,"450 - 5 lb. bags; 1784 - 18 lb. bags","Product may contain low thiamine levels (vitamin B1).",3/9/2013,"03/09/2013",9/4/2013,"09/04/2013"
"Veterinary",64581,"Ongoing","Schell & Kampeter, Inc.","Meta","MO","US","Voluntary: Firm Initiated","E-Mail","AL, CO, FL, GA, IN, KY, MD, MA, MI, MN, MO, NY, NC, OH, OK, PA, SC, VA, Canada, Costa Rica, Japan, Lebanon, Latvia, Poland, Russia, Sweden, Singapore, Slovenia, Taiwan","V-307-2013","Class I","Premium Edge Kitten Formula, 6 oz. samples, 6 lb. and 18 lb. bags, Premium Edge Pet Foods P.O. Box 156 Meta, MO 65058.","Production Code: MKT0901; Best Before: 26-Sept-2013, 29-Sept-2013, 30-Sept-2013 and 02-Oct-2013",,"43 - 6 oz. bags; 286 - 6 lb. bags; 1400 - 18 lb. bags","Product may contain low thiamine levels (vitamin B1).",3/9/2013,"03/09/2013",9/4/2013,"09/04/2013"
"Veterinary",64581,"Ongoing","Schell & Kampeter, Inc.","Meta","MO","US","Voluntary: Firm Initiated","E-Mail","AL, CO, FL, GA, IN, KY, MD, MA, MI, MN, MO, NY, NC, OH, OK, PA, SC, VA, Canada, Costa Rica, Japan, Lebanon, Latvia, Poland, Russia, Sweden, Singapore, Slovenia, Taiwan","V-305-2013","Class I","Premium Edge Finicky Adult Cat Formula, 6 lb. bags &18 lb. bags, Premium Edge Pet Foods P.O. Box 156 Meta, MO 65058.","Production Codes: NGF0802, Best By: 15-Aug-2013, 16-Aug-2013 (6 lb. bags) and Production Codes: NGF0703, Best By: 10-Jul-2013(18 lb. bags).",,"316 - 6 lb. bags; 2150 - 18 lb. bags","Product may contain low thiamine levels (vitamin B1).",3/9/2013,"03/09/2013",9/4/2013,"09/04/2013"
"Veterinary",64581,"Ongoing","Schell & Kampeter, Inc.","Meta","MO","US","Voluntary: Firm Initiated","E-Mail","AL, CO, FL, GA, IN, KY, MD, MA, MI, MN, MO, NY, NC, OH, OK, PA, SC, VA, Canada, Costa Rica, Japan, Lebanon, Latvia, Poland, Russia, Sweden, Singapore, Slovenia, Taiwan","V-306-2013","Class I","Premium Edge Senior Cat Hairball Management Formula, 6 lb. and 18 lb. bags, Premium Edge Pet Foods P.O. Box 156 Meta, MO 65058.","Production Codes: NGS0101, Best By: 03-Jan-2014, 04-Jan-2014 and Production Codes: NGS0702, Best By: 10-Jul-2013.",,"208 - 6 lb. bags; 2150 - 18 lb. bags","Product may contain low thiamine levels (vitamin B1).",3/9/2013,"03/09/2013",9/4/2013,"09/04/2013"
"Veterinary",64581,"Ongoing","Schell & Kampeter, Inc.","Meta","MO","US","Voluntary: Firm Initiated","E-Mail","AL, CO, FL, GA, IN, KY, MD, MA, MI, MN, MO, NY, NC, OH, OK, PA, SC, VA, Canada, Costa Rica, Japan, Lebanon, Latvia, Poland, Russia, Sweden, Singapore, Slovenia, Taiwan","V-310-2013","Class I","Nutra Gold Indoor Kitten Formula, 3 Kilogram and l Kilogram","Production Code: MKT0901, Best By: 26-Sep-2014 and 26-Mar-2014.",,"195 - 3 KG bags; 94 - 1 KG bags","Product may contain low thiamine levels (vitamin B1).",3/9/2013,"03/09/2013",9/4/2013,"09/04/2013"
"Veterinary",64581,"Ongoing","Schell & Kampeter, Inc.","Meta","MO","US","Voluntary: Firm Initiated","E-Mail","AL, CO, FL, GA, IN, KY, MD, MA, MI, MN, MO, NY, NC, OH, OK, PA, SC, VA, Canada, Costa Rica, Japan, Lebanon, Latvia, Poland, Russia, Sweden, Singapore, Slovenia, Taiwan","V-308-2013","Class I","Diamond Naturals Kitten Formula, 6 oz. samples and 6 lb. bags, Proudly made by Diamond Pet Foods, Meta, MO 65058 USA.","Production Codes: MKT0901, Best By: 30-Sept-2013",,"14 - 6 oz. bags; 287 - 6 lb. bags","Product may contain low thiamine levels (vitamin B1).",3/9/2013,"03/09/2013",9/4/2013,"09/04/2013"
"Veterinary",64582,"Ongoing","Jones Natural Chews, Co., Inc.","Rockford","IL","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","AZ, CA, CO, PA, VA, and WI","V-226-2013","Class I","Dog treat products as follows: a) Jones Natural Chews Co Woofers (beef patties), bulk 50 count box, Item UPC 741956008169 (may be sold individually at retail) b) Jones Natural Chews Co Woofers (beef patties), 1 pack shrink-wrap, 50 count box, Item UPC 741956008657 c) Jones Natural Chews Co Woofers (beef patties), 1 pack shrink-wrap, 50 count box, Item UPC 741956008183 d) Jones Natural Chews Co Woofers (beef patties) 2 pack shrink-wrap, 25 count box, Item UPC 741956008190","a) Lot 2962GPS, Best By 10/22/15, and Lot 2892PAL, Best By 10/15/15 b) Lot 3102, Best By 11/05/15 c) Lot 2892BF, Best By 10/15/15, Lot 2962PWV, Best By 10/22/15, Lot 2962ASC, Best By 10/22/15, and Lot 3032ASL, Best By 10/29/15 d) Lot 2962ASC, Best By 10/22/15, and Lot 3032ASL, Best By 10/29/15. ",,"245 boxes / 12,236 patties","This product is being recalled due to the possible risk of Salmonella.",3/6/2013,"03/06/2013",7/31/2013,"07/31/2013"
"Drugs",64583,"Ongoing","CareFusion 213, LLC","El Paso","TX","US","Voluntary: Firm Initiated","Letter","Nationwide, Puerto Rico, Virgin Islands, Malaysia, and United Kingdom","D-229-2013","Class II","FREPP/SEPP Kit containing 1 FREPP (povidone iodine 2% aqueous solution), Net 1.1 mL and 1 SEPP (povidone iodine 10% USP), Net 0.67 mL per kit, packaged in 20 kits per carton, Cat. No 260288, NDC 54365-202-99, CareFusion, Leawood, KS 66211.","All lots with expiry between 07/11 to 08/14.",,"544,500 kits","Labeling: Not Elsewhere Classified: This product is misbranded because the product is not sterile and the labeling is misleading in relation to sterility claims. ",3/4/2013,"03/04/2013",4/3/2013,"04/03/2013"
"Drugs",64583,"Ongoing","CareFusion 213, LLC","El Paso","TX","US","Voluntary: Firm Initiated","Letter","Nationwide, Puerto Rico, Virgin Islands, Malaysia, and United Kingdom","D-224-2013","Class II","SEPP 70% Isopropanol (isopropyl alcohol) 70% v/v, USP, 200-count applicators (net 0.67 mL each) per carton, Cat. No 260201, NDC 54365-170-01, CareFusion, Leawood, KS 66211.","All lots distributed between 01/10 to 02/13",,"698,000 applicators","Labeling: Not Elsewhere Classified: This product is misbranded because the product is not sterile and the labeling is misleading in relation to sterility claims. ",3/4/2013,"03/04/2013",4/3/2013,"04/03/2013"
"Drugs",64583,"Ongoing","CareFusion 213, LLC","El Paso","TX","US","Voluntary: Firm Initiated","Letter","Nationwide, Puerto Rico, Virgin Islands, Malaysia, and United Kingdom","D-228-2013","Class II","Donor Prep Kit containing 1 FREPP (70% isopropyl alcohol), Net 1.1 mL and 1 SEPP (iodine tincture 2% USP), Net 0.67 mL per kit, packaged in 20-count kits per carton, Cat. No 260311, NDC 54365-201-99, CareFusion, Leawood, KS 66211.","All lots with expiry between 09/11 to 09/13.",,"46,500 kits","Labeling: Not Elsewhere Classified: This product is misbranded because the product is not sterile and the labeling is misleading in relation to sterility claims. ",3/4/2013,"03/04/2013",4/3/2013,"04/03/2013"
"Drugs",64583,"Ongoing","CareFusion 213, LLC","El Paso","TX","US","Voluntary: Firm Initiated","Letter","Nationwide, Puerto Rico, Virgin Islands, Malaysia, and United Kingdom","D-226-2013","Class II","SEPP 10% Povidone Iodine Solution USP (1% available Iodine, Surfactant & USP Purified Water), packaged in a) 200-count applicators (Net 0.67 mL each) per carton, CareFusion, Leawood, KS 66211, Cat. No 260286, NDC 54365-145-01; and b) 3000-count applicators per case, Cat. No 260681, CareFusion, Leawood, KS 66211.","a) All lots with expiry between 09/12 to 10/15 and b) All lots with expiry between 10/11 to 07/14.",,"8,960,000 applicators","Labeling: Not Elsewhere Classified: This product is misbranded because the product is not sterile and the labeling is misleading in relation to sterility claims. ",3/4/2013,"03/04/2013",4/3/2013,"04/03/2013"
"Drugs",64583,"Ongoing","CareFusion 213, LLC","El Paso","TX","US","Voluntary: Firm Initiated","Letter","Nationwide, Puerto Rico, Virgin Islands, Malaysia, and United Kingdom","D-225-2013","Class II","SEPP 2% Iodine Tincture USP (47% v/v Ethyl Alcohol, 2% w/v Iodine, USP, Sodium Iodide USP, & Purified Water USP), packaged in a) 200-count applicators (Net 0.67 mL each) per carton, Cat. No 260261, NDC 54365-161-01, CareFusion, Leawood, KS 66211; b) 3000-count applicators (Net 0.67 mL each) per case, Cat. No 260431, NDC 54365-151-01, CareFusion, Leawood, KS 66211; and c) 3000-count applicators (Net 0.67 mL each) per case, Reorder TA6200, Manufactured for: Tri-State Hospital Supply Corporation, Howell, MI 48843.","a) All lots with expiry between 02/12 to 10/15; b) All lots with expiry between 09/11 to 12/13; and c) All lots with expiry between 12/11 to 12/11.",,"3,032,000 applicators","Labeling: Not Elsewhere Classified: This product is misbranded because the product is not sterile and the labeling is misleading in relation to sterility claims. ",3/4/2013,"03/04/2013",4/3/2013,"04/03/2013"
"Drugs",64583,"Ongoing","CareFusion 213, LLC","El Paso","TX","US","Voluntary: Firm Initiated","Letter","Nationwide, Puerto Rico, Virgin Islands, Malaysia, and United Kingdom","D-227-2013","Class II","Blood Culture Prep Kit II containing 1 FREPP (70% isopropyl alcohol), Net 1.1 mL and 1 SEPP (iodine tincture 2% USP), Net 0.67 mL per kit, packaged in 20-count kits per carton, Cat. No 260307, NDC 54365-200-99, CareFusion, Leawood, KS 66211.","All lots with expiry between 12/11 to 10/15.",,"929,000 kits","Labeling: Not Elsewhere Classified: This product is misbranded because the product is not sterile and the labeling is misleading in relation to sterility claims. ",3/4/2013,"03/04/2013",4/3/2013,"04/03/2013"
"Devices",64584,"Ongoing","Orthopedic Alliance LLC","Murrieta","CA","US","Voluntary: Firm Initiated","Letter","Distributed in Texas.","Z-1156-2013","Class II","Orthopedic Alliance Spine System (alias ''Blue & Gold'') Part Numbers: BGC3010 Screw Cap BGR0040 Straight Rod 5.5 x 40mm BGR0050 Straight Rod 5.5 x 50mm BGR0060 Straight Rod 5.5 x 60mm BGR0070 Straight Rod 5.5 x 70mm BGR0080 Straight Rod 5.5 x 80mm BGR0090 Straight Rod 5.5 x 90mm BGR0100 Straight Rod 5.5 x 100mm BGR0110 Straight Rod 5.5 x 110mm BGR0120 Straight Rod 5.5 x 120mm BGR0130 Straight Rod 5.5 x 130mm BGR0140 Straight Rod 5.5 x 140mm BGR0150 Straight Rod 5.5 x 150mm BGR0200 Straight Rod 5.5 x 200mm BGR0300 Straight Rod 5.5 x 300mm BGR0400 Straight Rod 5.5 x 400mm BGR0500 Straight Rod 5.5 x 500mm BGS5535 5.5 x 35mm Polyaxial Screw BGS5540 5.5 x 40mm Polyaxial Screw BGS5545 5.5 x 45mm Polyaxial Screw BGS6035 6.0 x 35mm Polyaxial Screw BGS6040 6.0 x 40mm Polyaxial Screw BGS6045 6.0 x 45mm Polyaxial Screw BGS6050 6.0 x 50mm Polyaxial Screw BGS6535 6.5 x 35mm Polyaxial Screw BGS6540 6.5 x 40mm Polyaxial Screw BGS6545 6.5 x 45mm Polyaxial Screw BGS6550 6.5 x 50mm Polyaxial Screw BGS7035 7.0 x 35mm Polyaxial Screw BGS7040 7.0 x 40mm Polyaxial Screw BGS7045 7.0 x 45mm Polyaxial Screw BGS7050 7.0 x 50mm Polyaxial Screw BGS7055 7.0 x 55mm Polyaxial Screw BGS7535 7.5 x 35mm Polyaxial Screw BGS7540 7.5 x 40mm Polyaxial Screw BGS7545 7.5 x 45mm Polyaxial Screw A pedicle screw system intended to provide immobilization and stabilization of spinal segments in skeletally mature patients. ","All lots are being recalled. ",".","3,300 units","Orthopedic Alliance is recalling Blue & Gold Implants and Instruments because the Blue & Gold system is not supported by adequate testing and documentation to demonstrate that it meets performance or safety standards. These inadequacies might result in product peformance failures that could cause patient harm due to implant breakage, loosening, or inadequate sterilization.",3/7/2013,"03/07/2013",5/1/2013,"05/01/2013"
"Devices",64585,"Ongoing","CareFusion 213, LLC","El Paso","TX","US","Voluntary: Firm Initiated","Letter","USA Nationwide Distribution","Z-1001-2013","Class III","Sepp, Compound Benzoin Tincture Packaged and Tincture 3,000 Bulk. Product Usage: Preoperative skin product","Tincture Packaged: Product Number 260619 and Product ID D086353; Tincture 3,000 Bulk: Product Number 260520 and Product ID D086353.",,"13,749,000","An internal review of CareFusion's labeling for preoperative skin prep product codes was recently conducted. The labeling of the product codes identified above state that the contents of the package are sterile and does not clarify that this sterility claim is only applicable to the applicator. The antiseptic solution that is applied to the skin is a cutaneous disinfectant, and is not sterilized. Some product labeling states ''Sterility guaranteed unless seal broken'' or ''Contents sterile if package is intact.'' These claims were intended to indicate surface sterilization only but could mistakenly lead to the conclusion that the drug product solution is sterile. It was determined that labeling on certain products could be misleading in relation to sterility claims. There is no patient safety risk associated with these products.",3/4/2013,"03/04/2013",4/3/2013,"04/03/2013"
"Devices",64586,"Ongoing","Spinal Solutions, LLC","Murrieta","CA","US","Voluntary: Firm Initiated","Letter","USA Nationwide Distribution in the states of MS: TX, NV, CA, MD, and WI.","Z-1413-2013","Class II","50 mm Rod, Item #BG1650 Product Usage: Spinal Solutions distributes a variety of spinal fixation devices in loaner bins or on consignment. The company has decided to provide directions for use and surgical techniques electronically on the companys website. The company has created a label intended to inform the user of the existence of the websites and the information it contains. Indications for use: multiple. ","Item #BG1650",".","55 units","The recall of the Loaner Bin and Sterilization Trays for implants and instruments was initiated by Spinal Solutions because the directions for use and surgical techniques were not being provided to every physician and for every surgery.",2/20/2013,"02/20/2013",6/5/2013,"06/05/2013"
"Devices",64586,"Ongoing","Spinal Solutions, LLC","Murrieta","CA","US","Voluntary: Firm Initiated","Letter","USA Nationwide Distribution in the states of MS: TX, NV, CA, MD, and WI.","Z-1416-2013","Class II","14 x 11 x 6mm 7 deg 14 x 11 x 7mm 7 deg 14 x 11 x 8mm 7 deg 14 x 11 x 9mm 7 deg 14 x 11 x 10mm 7 deg 14 x 11 x 11mm 7 deg 14 x 11 x 12mm 7 deg Product Usage: Spinal Solutions distributes a variety of spinal fixation devices in loaner bins or on consignment. The company has decided to provide directions for use and surgical techniques electronically on the companys website. The company has created a label intended to inform the user of the existence of the websites and the information it contains. Indications for use: multiple. ","Item # 21411-706 21411-707 21411-708 21411-709 21411-710 21411-711 21411-712 ",".","35 units","The recall of the Loaner Bin and Sterilization Trays for implants and instruments was initiated by Spinal Solutions because the directions for use and surgical techniques were not being provided to every physician and for every surgery.",2/20/2013,"02/20/2013",6/5/2013,"06/05/2013"
"Devices",64586,"Ongoing","Spinal Solutions, LLC","Murrieta","CA","US","Voluntary: Firm Initiated","Letter","USA Nationwide Distribution in the states of MS: TX, NV, CA, MD, and WI.","Z-1412-2013","Class II","40 mm Rod, Item #BG1640 Product Usage: Spinal Solutions distributes a variety of spinal fixation devices in loaner bins or on consignment. The company has decided to provide directions for use and surgical techniques electronically on the companys website. The company has created a label intended to inform the user of the existence of the websites and the information it contains. Indications for use: multiple. ","Item #BG1640",".","63 units","The recall of the Loaner Bin and Sterilization Trays for implants and instruments was initiated by Spinal Solutions because the directions for use and surgical techniques were not being provided to every physician and for every surgery.",2/20/2013,"02/20/2013",6/5/2013,"06/05/2013"
"Devices",64586,"Ongoing","Spinal Solutions, LLC","Murrieta","CA","US","Voluntary: Firm Initiated","Letter","USA Nationwide Distribution in the states of MS: TX, NV, CA, MD, and WI.","Z-1417-2013","Class II","Copperhead IBFD, Large Neutral, 6mm Copperhead IBFD, Large Neutral, 7mm Copperhead IBFD, Large Neutral, 8mm Copperhead IBFD, Large Neutral, 9mm Copperhead IBFD, Large Neutral, 10mm Copperhead IBFD, Large Neutral, 11mm Product Usage: Spinal Solutions distributes a variety of spinal fixation devices in loaner bins or on consignment. The company has decided to provide directions for use and surgical techniques electronically on the companys website. The company has created a label intended to inform the user of the existence of the websites and the information it contains. Indications for use: multiple. ","Item # C5006 C5007 C5008 C5009 C5010 C5011 ",".","24 units","The recall of the Loaner Bin and Sterilization Trays for implants and instruments was initiated by Spinal Solutions because the directions for use and surgical techniques were not being provided to every physician and for every surgery.",2/20/2013,"02/20/2013",6/5/2013,"06/05/2013"
"Devices",64586,"Ongoing","Spinal Solutions, LLC","Murrieta","CA","US","Voluntary: Firm Initiated","Letter","USA Nationwide Distribution in the states of MS: TX, NV, CA, MD, and WI.","Z-1414-2013","Class II","60 mm Rod, Item #BG1660 Product Usage: Spinal Solutions distributes a variety of spinal fixation devices in loaner bins or on consignment. The company has decided to provide directions for use and surgical techniques electronically on the companys website. The company has created a label intended to inform the user of the existence of the websites and the information it contains. Indications for use: multiple. ","Item #BG1660",".","72 units","The recall of the Loaner Bin and Sterilization Trays for implants and instruments was initiated by Spinal Solutions because the directions for use and surgical techniques were not being provided to every physician and for every surgery.",2/20/2013,"02/20/2013",6/5/2013,"06/05/2013"
"Devices",64586,"Ongoing","Spinal Solutions, LLC","Murrieta","CA","US","Voluntary: Firm Initiated","Letter","USA Nationwide Distribution in the states of MS: TX, NV, CA, MD, and WI.","Z-1411-2013","Class II","Set Screw, Item #BG3010 Product Usage: Spinal Solutions distributes a variety of spinal fixation devices in loaner bins or on consignment. The company has decided to provide directions for use and surgical techniques electronically on the companys website. The company has created a label intended to inform the user of the existence of the websites and the information it contains. Indications for use: multiple. ","Item #BG3010",".","106 units","The recall of the Loaner Bin and Sterilization Trays for implants and instruments was initiated by Spinal Solutions because the directions for use and surgical techniques were not being provided to every physician and for every surgery.",2/20/2013,"02/20/2013",6/5/2013,"06/05/2013"
"Devices",64586,"Ongoing","Spinal Solutions, LLC","Murrieta","CA","US","Voluntary: Firm Initiated","Letter","USA Nationwide Distribution in the states of MS: TX, NV, CA, MD, and WI.","Z-1409-2013","Class II","45 mm Screw, Item #BG7045 Product Usage: Spinal Solutions distributes a variety of spinal fixation devices in loaner bins or on consignment. The company has decided to provide directions for use and surgical techniques electronically on the companys website. The company has created a label intended to inform the user of the existence of the websites and the information it contains. Indications for use: multiple. ","Item #BG7045",".","24 units","The recall of the Loaner Bin and Sterilization Trays for implants and instruments was initiated by Spinal Solutions because the directions for use and surgical techniques were not being provided to every physician and for every surgery.",2/20/2013,"02/20/2013",6/5/2013,"06/05/2013"
"Devices",64586,"Ongoing","Spinal Solutions, LLC","Murrieta","CA","US","Voluntary: Firm Initiated","Letter","USA Nationwide Distribution in the states of MS: TX, NV, CA, MD, and WI.","Z-1410-2013","Class II","50 mm Screw, Item #BG7050 Product Usage: Spinal Solutions distributes a variety of spinal fixation devices in loaner bins or on consignment. The company has decided to provide directions for use and surgical techniques electronically on the companys website. The company has created a label intended to inform the user of the existence of the websites and the information it contains. Indications for use: multiple. ","Item #BG7050",".","52 units","The recall of the Loaner Bin and Sterilization Trays for implants and instruments was initiated by Spinal Solutions because the directions for use and surgical techniques were not being provided to every physician and for every surgery.",2/20/2013,"02/20/2013",6/5/2013,"06/05/2013"
"Devices",64586,"Ongoing","Spinal Solutions, LLC","Murrieta","CA","US","Voluntary: Firm Initiated","Letter","USA Nationwide Distribution in the states of MS: TX, NV, CA, MD, and WI.","Z-1415-2013","Class II","12mm x 27mm x 8mm 12mm x 27mm x 9mm 12mm x 27mm x 10mm 12mm x 27mm x 11mm 12mm x 27mm x 12mm 12mm x 27mm x 13mm 12mm x 27mm x 14mm Product Usage: Spinal Solutions distributes a variety of spinal fixation devices in loaner bins or on consignment. The company has decided to provide directions for use and surgical techniques electronically on the companys website. The company has created a label intended to inform the user of the existence of the websites and the information it contains. Indications for use: multiple. ","Item # 10227-008 10227-009 10227-010 10227-011 10227-012 10227-013 10227-014 ",".","56 units","The recall of the Loaner Bin and Sterilization Trays for implants and instruments was initiated by Spinal Solutions because the directions for use and surgical techniques were not being provided to every physician and for every surgery.",2/20/2013,"02/20/2013",6/5/2013,"06/05/2013"
"Devices",64586,"Ongoing","Spinal Solutions, LLC","Murrieta","CA","US","Voluntary: Firm Initiated","Letter","USA Nationwide Distribution in the states of MS: TX, NV, CA, MD, and WI.","Z-1418-2013","Class II","Fang Screw 20mm Fang Plate 21mm Product Usage: Spinal Solutions distributes a variety of spinal fixation devices in loaner bins or on consignment. The company has decided to provide directions for use and surgical techniques electronically on the companys website. The company has created a label intended to inform the user of the existence of the websites and the information it contains. Indications for use: multiple. ","Item # FP1220 FP1221 ",".","16 units","The recall of the Loaner Bin and Sterilization Trays for implants and instruments was initiated by Spinal Solutions because the directions for use and surgical techniques were not being provided to every physician and for every surgery.",2/20/2013,"02/20/2013",6/5/2013,"06/05/2013"
"Devices",64588,"Ongoing","Orthopedic Alliance LLC","Murrieta","CA","US","Voluntary: Firm Initiated","Letter","Nationwide Distribution including the states of CA, MD, TX, NV, and WI.","Z-1386-2013","Class II","Ball Head, 28 Short CERAMIC Ball Head, 28 Medium CERAMIC Ball Head, 28 Long CERAMIC Ball Head, 32 Short CERAMIC Ball Head, 32 Medium CERAMIC Ball Head, 32 Long CERAMIC Ball Head, 28 Short CoCr Ball Head, 28 Medium CoCr Ball Head, 28 Long CoCr Ball Head, 28 X-Long CoCr Ball Head, 28 XX-Long CoCr Ball Head, 32 Short Ball Head, 32 Medium Ball Head, 32 Long ","Part No. 194.01.28 194.02.28 194.03.28 195.01.32 195.02.32 195.03.32 188.01.28 188.02.28 188.03.28 188.04.28 188.05.28 189.01.32 189.02.32 189.03.32 ",".","26 units","The recall of the Loaner Bin and Sterilization Trays for implants and instruments was initiated by Orthopedic Alliance because the directions for use and surgical techniques were not being provided to every physician and for every surgery.",2/20/2013,"02/20/2013",6/5/2013,"06/05/2013"
"Devices",64588,"Ongoing","Orthopedic Alliance LLC","Murrieta","CA","US","Voluntary: Firm Initiated","Letter","Nationwide Distribution including the states of CA, MD, TX, NV, and WI.","Z-1378-2013","Class II","Femoral component, CR, cemented, #1, left 2103-1310 Femoral component, CR, cemented, #2, left 2103-1320 Femoral component, CR, cemented, #3, left 2103-1330 Femoral component, CR, cemented, #4, left 2103-1340 Femoral component, CR, cemented, #5, left 2103-1350 Femoral component, CR, cemented, #6, left 2103-1360 Femoral component, CR, cemented, #1, right 2103-1410 Femoral component, CR, cemented, #2, right 2103-1420 Femoral component, CR, cemented, #3, right 2103-1430 Femoral component, CR, cemented, #4, right 2103-1440 Femoral component, CR, cemented, #5, right 2103-1450 Femoral component, CR, cemented, #6, right 2103-1460 Femoral component, PS, #1, left 2103-3110 Femoral component, PS, #2, left 2103-3120 Femoral component, PS, #3, left 2103-3130 Femoral component, PS, #4, left 2103-3140 Femoral component, PS, #5, left 2103-3150 Femoral component, PS, #6, left 2103-3160 Femoral component,PS, #1, right 2103-3210 Femoral component,PS, #2, right 2103-3220 Femoral component,PS, #3, right 2103-3230 Femoral component,PS, #4, right 2103-3240 Femoral component,PS, #5, right 2103-3250 Femoral component,PS, #6, right 2103-3260 Variety of hip and knee implants and instruments, multiple uses. ","Catalog No. 2103-1310 2103-1320 2103-1330 2103-1340 2103-1350 2103-1360 2103-1410 2103-1420 2103-1430 2103-1440 2103-1450 2103-1460 2103-3110 2103-3120 2103-3130 2103-3140 2103-3150 2103-3160 2103-3210 2103-3220 2103-3230 2103-3240 2103-3250 2103-3260 ",".","136 units","The recall of the Loaner Bin and Sterilization Trays for implants and instruments was initiated by Orthopedic Alliance because the directions for use and surgical techniques were not being provided to every physician and for every surgery.",2/20/2013,"02/20/2013",6/5/2013,"06/05/2013"
"Devices",64588,"Ongoing","Orthopedic Alliance LLC","Murrieta","CA","US","Voluntary: Firm Initiated","Letter","Nationwide Distribution including the states of CA, MD, TX, NV, and WI.","Z-1382-2013","Class II","Femoral head, standard, 26mm, +0mm Femoral head,medium, 26mm,+3mm Femoral head, long, 26mm, +6mm Femoral head, X-long, 26mm, +9mm Femoral head, 28mm, -3mm Femoral head, 28mm, +0mm Femoral head, 28mm, +5mm Femoral head, 28mm, +10mm Femoral head, 32mm, -3mm Femoral head, 32mm, +0mm Femoral head, 32mm, +5mm Femoral head, 32mm, +10mm Femoral head, 36mm, -3mm Femoral head, 36mm, +0mm Femoral head, 36mm, +5mm Femoral head, 36mm, +10mm Variety of hip and knee implants and instruments, multiple uses. ","Item No. 1201-1126 1201-1326 1201-1526 1201-1726 1201-1028 1201-1128 1201-1428 1201-1828 1201-1032 1201-1132 1201-1432 1201-1832 1201-1036 1201-1136 1201-1436 1201-1836 ",".","21 units","The recall of the Loaner Bin and Sterilization Trays for implants and instruments was initiated by Orthopedic Alliance because the directions for use and surgical techniques were not being provided to every physician and for every surgery.",2/20/2013,"02/20/2013",6/5/2013,"06/05/2013"
"Devices",64588,"Ongoing","Orthopedic Alliance LLC","Murrieta","CA","US","Voluntary: Firm Initiated","Letter","Nationwide Distribution including the states of CA, MD, TX, NV, and WI.","Z-1385-2013","Class II","Zweimueller Type Stem SCS-Standard Sz 01 Zweimueller Type Stem SCS-Standard Sz 00 Zweimueller Type Stem SCS-Standard Sz 1 Zweimueller Type Stem SCS-Standard Sz 2 Zweimueller Type Stem SCS-Standard Sz 3 Zweimueller Type Stem SCS-Standard Sz 4 Zweimueller Type Stem SCS-Standard Sz 5 Zweimueller Type Stem SCS-Standard Sz 6 Zweimueller Type Stem SCS-Standard Sz 7 Zweimueller Type Stem SCS-Standard Sz 8 Zweimueller Type Stem SCS-Standard Sz 9 Zweimueller Type Stem SCS-Standard Sz 10 Zweimueller Type Stem SCL-Lateralized Sz 3 Zweimueller Type Stem SCL-Lateralized Sz 4 Zweimueller Type Stem SCL-Lateralized Sz 5 Zweimueller Type Stem SCL-Lateralized Sz 6 Zweimueller Type Stem SCL-Lateralized Sz 7 Zweimueller Type Stem SCL-Lateralized Sz 8 Zweimueller Type Stem SCL-Lateralized Sz 9 Zweimueller Type Stem SCR-Revision Sz 3 Zweimueller Type Stem SCR-Revision Sz 4 Zweimueller Type Stem SCR-Revision Sz 5 Zweimueller Type Stem SCR-Revision Sz 6 Zweimueller Type Stem SCR-Revision Sz 7 Zweimueller Type Stem SCR-Revision Sz 8 Zweimueller Type Stem SCR-Revision Sz 9 Zweimueller Type Stem SCR-Revision Sz 10 Zweimueller Type Stem SCR-Revision Sz 11 Variety of hip and knee implants and instruments, multiple uses. ","Part No. 120.00.15 120.00.00 120.00.01 120.00.02 120.00.03 120.00.04 120.00.05 120.00.06 120.00.07 120.00.08 120.00.09 120.00.10 123.00.03 123.00.04 123.00.05 123.00.06 123.00.07 123.00.08 123.00.09 126.00.03 126.00.04 126.00.05 126.00.06 126.00.07 126.00.08 126.00.09 126.00.10 126.00.11 ",".","50 units","The recall of the Loaner Bin and Sterilization Trays for implants and instruments was initiated by Orthopedic Alliance because the directions for use and surgical techniques were not being provided to every physician and for every surgery.",2/20/2013,"02/20/2013",6/5/2013,"06/05/2013"
"Devices",64588,"Ongoing","Orthopedic Alliance LLC","Murrieta","CA","US","Voluntary: Firm Initiated","Letter","Nationwide Distribution including the states of CA, MD, TX, NV, and WI.","Z-1379-2013","Class II","Tibial baseplate,cemented,#1 2203-3010 Tibial baseplate,cemented,#2 2203-3020 Tibial baseplate,cemented,#3 2203-3030 Tibial baseplate,cemented,#4 2203-3040 Tibial baseplate, cemented, #5 2203-3050 Tibial baseplate, cemented, #6 2203-3060 Tibial insert,CR,plained,#1,9mm 2303-1211 Tibial insert,CR,plained,#1,11mm 2303-1212 Tibial insert,CR,plained,#1,13mm 2303-1213 Tibial insert,CR,plained,#1,15mm 2303-1214 Tibial insert,CR,plained,#1,18mm 2303-1215 Tibial insert,CR,plained,#2,9mm 2303-1221 Tibial insert,CR,plained,#2,11mm 2303-1222 Tibial insert,CR,plained,#2,13mm 2303-1223 Tibial insert,CR,plained,#2,15mm 2303-1224 Tibial insert,CR,plained,#2,18mm 2303-1225 Tibial insert,CR,plained,#3,9mm 2303-1231 Tibial insert,CR,plained,#3,11mm 2303-1232 Tibial insert,CR,plained,#3,13mm 2303-1233 Tibial insert,CR,plained,#3,15mm 2303-1234 Tibial insert,CR,plained,#3,18mm 2303-1235 Tibial insert,CR,plained,#4,9mm 2303-1241 Tibial insert,CR,plained,#4,11mm 2303-1242 Tibial insert,CR,plained,#4,13mm 2303-1243 Tibial insert,CR,plained,#4,15mm 2303-1244 Tibial insert,CR,plained,#4,18mm 2303-1245 Tibial insert,CR,plained,#5,9mm 2303-1251 Tibial insert,CR,plained,#5,11mm 2303-1252 Tibial insert,CR,plained,#5,13mm 2303-1253 Tibial insert,CR,plained,#5,15mm 2303-1254 Tibial insert,CR,plained,#5,18mm 2303-1255 Tibial insert,CR,plained,#6,9mm 2303-1261 Tibial insert,CR,plained,#6,11mm 2303-1262 Tibial insert,CR,plained,#6,13mm 2303-1263 Tibial insert,CR,plained,#6,15mm 2303-1264 Tibial insert,CR,plained,#6,18mm 2303-1265 Tibial insert, PS , #1, 9mm 2303-3011 Tibial insert, PS , #1, 11mm 2303-3012 Tibial insert, PS , #1, 13mm 2303-3013 Tibial insert, PS , #1, 15mm 2303-3014 Tibial insert, PS , #1, 18mm 2303-3015 Tibial insert, PS , #2, 9mm 2303-3021 Tibial insert, PS , #2, 11mm 2303-3022 Tibial insert, PS , #2, 13mm 2303-3023 Tibial insert, PS , #2, 15mm 2303-3024 Tibial insert, PS , #2, 18mm 2303-3025 Tibial insert, PS , #3, 9mm 2303-3031 Tibi","Catalog No. 2203-3010 2203-3020 2203-3030 2203-3040 2203-3050 2203-3060 2303-1211 2303-1212 2303-1213 2303-1214 2303-1215 2303-1221 2303-1222 2303-1223 2303-1224 2303-1225 2303-1231 2303-1232 2303-1233 2303-1234 2303-1235 2303-1241 2303-1242 2303-1243 2303-1244 2303-1245 2303-1251 2303-1252 2303-1253 2303-1254 2303-1255 2303-1261 2303-1262 2303-1263 2303-1264 2303-1265 2303-3011 2303-3012 2303-3013 2303-3014 2303-3015 2303-3021 2303-3022 2303-3023 2303-3024 2303-3025 2303-3031 2303-3032 2303-3033 2303-3034 2303-3035 2303-3041 2303-3042 2303-3043 2303-3044 2303-3045 2303-3051 2303-3052 2303-3053 2303-3054 2303-3055 2303-3061 2303-3062 2303-3063 2303-3064 2303-3065 ",".","459 units","The recall of the Loaner Bin and Sterilization Trays for implants and instruments was initiated by Orthopedic Alliance because the directions for use and surgical techniques were not being provided to every physician and for every surgery.",2/20/2013,"02/20/2013",6/5/2013,"06/05/2013"
"Devices",64588,"Ongoing","Orthopedic Alliance LLC","Murrieta","CA","US","Voluntary: Firm Initiated","Letter","Nationwide Distribution including the states of CA, MD, TX, NV, and WI.","Z-1381-2013","Class II","U2 Acetabular cup, Ti beads porous coated, 44mm U2 Acetabular cup, Ti beads porous coated, 46mm U2 Acetabular cup, Ti beads porous coated, 48mm U2 Acetabular cup, Ti beads porous coated, 50mm U2 Acetabular cup, Ti beads porous coated, 52mm U2 Acetabular cup, Ti beads porous coated, 54mm U2 Acetabular cup, Ti beads porous coated, 56mm U2 Acetabular cup, Ti beads porous coated, 58mm U2 Acetabular cup, Ti beads porous coated, 60mm U2 Acetabular cup, Ti beads porous coated, 62mm U2 Acetabular cup liner assembly, 10hooded,44mm U2 Acetabular cup liner assembly, 10hooded,46mm U2 Acetabular cup liner assembly, 10hooded,48mm U2 Acetabular cup liner assembly, 10hooded,50mm U2 Acetabular cup liner assembly, 10hooded,52mm U2 Acetabular cup liner assembly, 10hooded,54mm U2 Acetabular cup liner assembly, 10hooded,56mm U2 Acetabular cup liner assembly, 10hooded,58mm U2 Acetabular cup liner assembly, 10hooded,60mm U2 Acetabular cup liner assembly, 10hooded,62mm Variety of hip and knee implants and instruments, multiple uses. ","Item No. 1303-5444 1303-5446 1303-5448 1303-5450 1303-5452 1303-5454 1303-5456 1303-5458 1303-5460 1303-5462 1403-1044 1403-1046 1403-1048 1403-1250 1403-1252 1403-1654 1403-1656 1403-1658 1403-1660 1403-1662 ",".","30 units","The recall of the Loaner Bin and Sterilization Trays for implants and instruments was initiated by Orthopedic Alliance because the directions for use and surgical techniques were not being provided to every physician and for every surgery.",2/20/2013,"02/20/2013",6/5/2013,"06/05/2013"
"Devices",64588,"Ongoing","Orthopedic Alliance LLC","Murrieta","CA","US","Voluntary: Firm Initiated","Letter","Nationwide Distribution including the states of CA, MD, TX, NV, and WI.","Z-1380-2013","Class II","UKNEE Patella,small 2401-1010 UKNEE Patella,medium 2401-1020 UKNEE Patella,large 2401-1030 UKNEE Patella,X-large 2401-1040 UKNEE Onset Patella, 3 pegs, x-small 2403-1010 UKNEE Onset Patella, 3 pegs, small 2403-1020 UKNEE Onset Patella, 3 pegs, medium 2403-1030 UKNEE Onset Patella, 3 pegs, large 2403-1040 UKNEE Onset Patella, 3 pegs,X-large 2403-1050 Variety of hip and knee implants and instruments, multiple uses. ","Catalog No. 2401-1010 2401-1020 2401-1030 2401-1040 2403-1010 2403-1020 2403-1030 2403-1040 2403-1050 ",".","57 units","The recall of the Loaner Bin and Sterilization Trays for implants and instruments was initiated by Orthopedic Alliance because the directions for use and surgical techniques were not being provided to every physician and for every surgery.",2/20/2013,"02/20/2013",6/5/2013,"06/05/2013"
"Devices",64588,"Ongoing","Orthopedic Alliance LLC","Murrieta","CA","US","Voluntary: Firm Initiated","Letter","Nationwide Distribution including the states of CA, MD, TX, NV, and WI.","Z-1383-2013","Class II","Bipolar Cap, ID26mm, OD42mm Bipolar Cap, ID28mm, OD44mm Bipolar Cap, ID28mm, OD46mm Bipolar Cap, ID28mm, OD48mm Bipolar Cap, ID28mm, OD50mm Bipolar Cap, ID28mm, OD52mm Bipolar Cap, ID28mm, OD54mm Bipolar Cap, ID28mm, OD56mm ","Item No. 1503-3042 1503-3144 1503-3146 1503-3148 1503-3150 1503-3152 1503-3154 1503-3156 ",".","37 units","The recall of the Loaner Bin and Sterilization Trays for implants and instruments was initiated by Orthopedic Alliance because the directions for use and surgical techniques were not being provided to every physician and for every surgery.",2/20/2013,"02/20/2013",6/5/2013,"06/05/2013"
"Devices",64588,"Ongoing","Orthopedic Alliance LLC","Murrieta","CA","US","Voluntary: Firm Initiated","Letter","Nationwide Distribution including the states of CA, MD, TX, NV, and WI.","Z-1384-2013","Class II","Co-Cr cancellous bone screw,15mm Co-Cr cancellous bone screw,20mm Co-Cr cancellous bone screw,25mm Co-Cr cancellous bone screw,30mm Co-Cr cancellous bone screw,35mm Co-Cr cancellous bone screw,40mm Variety of hip and knee implants and instruments, multiple uses. ","Item No. 5201-6715 5201-6720 5201-6725 5201-6730 5201-6735 5201-6740 ",".","5 units","The recall of the Loaner Bin and Sterilization Trays for implants and instruments was initiated by Orthopedic Alliance because the directions for use and surgical techniques were not being provided to every physician and for every surgery.",2/20/2013,"02/20/2013",6/5/2013,"06/05/2013"
"Devices",64589,"Ongoing","Carestream Health, Inc.","Rochester","NY","US","Voluntary: Firm Initiated","Letter","USA Nationwide Distribution","Z-0999-2013","Class II","CareStream Dental CS 2100 X-ray system Product Usage: The expected usage (intended use) for all of these products is for dental radiographic examination and diagnosis of the teeth, jaw and oral structures. ","CS 2100",,"167 installed in the US","There have been approximately 2% of the x-ray generators manufactured between February 2012 and November 2012 returned due to errors. These generators showed the type of defect that indicates poor contact of HT transformer power pin. The defect is a bent connector associated with the generator.",9/18/2012,"09/18/2012",5/8/2013,"05/08/2013"
"Devices",64589,"Ongoing","Carestream Health, Inc.","Rochester","NY","US","Voluntary: Firm Initiated","Letter","USA Nationwide Distribution","Z-1094-2013","Class II","CareStream Dental Kodak 2100 X-ray system Product Usage: The expected usage (intended use) for all of these products is for dental radiographic examination and diagnosis of the teeth, jaw and oral structures. ","CS 2100",,"167 installed in the US","There have been approximately 2% of the x-ray generators manufactured between February 2012 and November 2012 returned due to errors. These generators showed the type of defect that indicates poor contact of HT transformer power pin. The defect is a bent connector associated with the generator.",9/18/2012,"09/18/2012",5/8/2013,"05/08/2013"
"Devices",64589,"Ongoing","Carestream Health, Inc.","Rochester","NY","US","Voluntary: Firm Initiated","Letter","USA Nationwide Distribution","Z-1000-2013","Class II","CareStream Dental CS 2200 X-ray system Product Usage: The expected usage (intended use) for all of these products is for dental radiographic examination and diagnosis of the teeth, jaw and oral structures. ","CS 2200",,"167 installed in the US ","There have been approximately 2% of the x-ray generators manufactured between February 2012 and November 2012 returned due to errors. These generators showed the type of defect that indicates poor contact of HT transformer power pin. The defect is a bent connector associated with the generator.",9/18/2012,"09/18/2012",5/8/2013,"05/08/2013"
"Devices",64589,"Ongoing","Carestream Health, Inc.","Rochester","NY","US","Voluntary: Firm Initiated","Letter","USA Nationwide Distribution","Z-1095-2013","Class II","CareStream Dental Kodak 2200 X-ray system Product Usage: The expected usage (intended use) for all of these products is for dental radiographic examination and diagnosis of the teeth, jaw and oral structures. ","CS 2200",,"167 installed in the US","There have been approximately 2% of the x-ray generators manufactured between February 2012 and November 2012 returned due to errors. These generators showed the type of defect that indicates poor contact of HT transformer power pin. The defect is a bent connector associated with the generator.",9/18/2012,"09/18/2012",5/8/2013,"05/08/2013"
"Biologics",64590,"Terminated","Mercy Hospital St Louis","Saint Louis","MO","US","Voluntary: Firm Initiated","Telephone","Missouri","B-1481-13","Class II","Whole Blood Leukocytes Reduced","W069613000559; ",".","1","Blood product, collected from a donor whose suitability to donate was not adequately determined, was distributed.",2/15/2013,"02/15/2013",6/19/2013,"06/19/2013"
"Biologics",64591,"Terminated","Mercy Hospital St Louis","Saint Louis","MO","US","Voluntary: Firm Initiated","Telephone","Missouri; California","B-1479-13","Class III","Blood and Blood Products for Reprocessing","W069613000067; ",".","1","Blood products, collected from a donor whose suitability to donate was not adequately determined, were distributed.",2/15/2013,"02/15/2013",6/19/2013,"06/19/2013"
"Biologics",64591,"Terminated","Mercy Hospital St Louis","Saint Louis","MO","US","Voluntary: Firm Initiated","Telephone","Missouri; California","B-1478-13","Class II","Whole Blood Leukocytes Reduced","W069613000067; ",".","1","Blood products, collected from a donor whose suitability to donate was not adequately determined, were distributed.",2/15/2013,"02/15/2013",6/19/2013,"06/19/2013"
"Devices",64593,"Ongoing","Arrow International Inc","Reading","PA","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution - USA including Puerto Rico and the states of AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI and WV. and the countries of Australia, Dominican Republic, Uruguay, Ecuador, Chile, Taiwan, Pakistan, Colombia, Argentina, Korea Republic, New Zealand, Guatemala, Thailand, Peru, Bahamas, Philippines, Trinidad and Tobago, Japan, Ireland, India, Singapore, China, Canada and Mexico.","Z-1057-2013","Class II","Arrow/Teleflex Medical Berman Angiographic Balloon Catheter and Reverse Berman Angiographic Balloon Catheter. The Arrow Berman(TM) Angiographic Catheter is indicated for use in right heart catheterization for cardiac angiography, and measurement of the right heart and pulmonary artery pressures. It can be sued to inject radiopaque media and measure pressures in any chamber or vessel that can be entered from the right heart. The Arrow Berman(TM) Angiographic Catheter is also indicated for use in Balloon Occlusion Femoral Angiography (BOFA) of the ipsilateral leg for adult patients. The Arrow Reverse Berman(TM) Angiographic Catheter is indicated for balloon occlusion pulmonary angiography.","Part Numbers --AI-07035, AI-07131, AI-07135, AI-07037, AI-07132, AI-07136, AI-07130, AI-07133, AI-07137, AI-07130-J, AI-07134, AND AI-07138.",".","99627ea","The product specifications sheet, part of the Instructions for Use (IFU), for the specified product numbers, reference Renografin-76 contrast medium (viscosity of 8.4 centipoise), which is no longer available. Firm is in the process of updating the labeling for these products. In the meantime, when choosing an alternative contrast medium, health care providers are instructed to select a contrast medium with a viscosity of 8.4 centipoise or lower for use with the pressure and flow settings specified in the current IFU.",3/4/2013,"03/04/2013",4/10/2013,"04/10/2013"
"Devices",64594,"Terminated","Stellate Systems","Westmount",,"CA","Voluntary: Firm Initiated","Letter","Worldwide distribution: USA (nationwide) including states of: AL, AR, AZ, CA, CT, DE, FL, HI, IA, IN, IL, KS, KY, LA, MA, MD, ME, MI, MN, MO, NC, ND, NJ, NY, OH, OR, PA, RI, SC, TX, VA, VT, WI, WV, and WY; and the countries of: Argentina, Australia, Bahrain, Brasil, Canada, China, Denmark, Finland, France, Germany, Greece, Haiti, Hong Kong, Hungary, Indonesia, Iran, Israel, Italy, Japan, Korea, KSA, Mexico, Netherlands, Norway, Pakistan, Portugal, Rep. DE Panama, Saudi Arabia, Spain, Switzerland, Taiwan ROC, Thailand, Turkey, and United Kingdom.","Z-1080-2013","Class II","Harmonie software versions 5.1 uo to 6.2e : Harmonie-E Long Term Monitoring system (Models HSYS-REC-WD, HSYS-REC-WT; HSYS-REC0LT2; HSYS-REC-EAMP) Product in use with Harmonie-E Long Term Monitoring System : ICTA-S & ICTA-D Seizure Detector, Slow wave Seizure Detector Harmonie-S Sleep System: Rapid Eye Movement Detector, Spindle Detector, Heart Rate Processor, Periodic Leg Movement Detector and Oximetry/Pulse rate Threshold Notification VITA/ICU Neurological Monitoring System: Burst Suppression Detector, Cerebral Function Monitor Trend, Visual and Auditory Notifications on all trends graphs in PolyTrends Harmonie {-s}{-E} Readers , ","Models HSYS-REC-WD, HSYS-REC-WT; HSYS-REC0LT2; HSYS-REC-EAMP Model HSYS-REC-DUO-PPC Model HSYS-REC-DUO-PPC Models HSYS-RDR-D, HSYS-RDR-T",".","2660 Software licenses","The firm is initiating this recall because the implied or stated indications in their labeling associated with Harmonie software have not yet been cleared by the FDA for sale in the USA.",4/6/2009,"04/06/2009",5/1/2013,"05/01/2013"
"Food",64595,"Ongoing","Nutrex Research, Inc.","Oviedo","FL","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","CT, FL, GA, IL, MA, NJ, NV, and TX","F-1300-2013","Class I","Nutrex Research Lipo 6 Black Ultra concentrate Fat Destroyer","Lot # 50000114 Best by: 01/2015",,"82,417 sample packets (1 capsule each)","Product samples contain DMAA (Methylhexanamine).",2/21/2013,"02/21/2013",4/17/2013,"04/17/2013"
"Food",64595,"Ongoing","Nutrex Research, Inc.","Oviedo","FL","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","CT, FL, GA, IL, MA, NJ, NV, and TX","F-1300-2013","Class I","Nutrex Research Lipo 6 Black Ultra concentrate Fat Destroyer","Lot # 50000114 Best by: 01/2015",,"82,417 sample packets (1 capsule each)","Product samples contain DMAA (Methylhexanamine).",2/21/2013,"02/21/2013",5/8/2013,"05/08/2013"
"Devices",64596,"Ongoing","Siemens Healthcare Diagnostics, Inc.","Newark","DE","US","Voluntary: Firm Initiated","Letter","Distributed within the US to AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, IA, ID, IL, IN, KS, KY, LA, MA, MD, MI, MN, MO, MS, MT, NC, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PR, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV, and WY.","Z-1151-2013","Class II","Siemens Dimension Vista(R) System Vista Drug 4 Calibrator. The device is used as an in vitro diagnostic product.","Catalog Number KC460, SMN 10472284, lot 2KD052, exp 5/1/14 and Catalog Number KC460A, SMN 10476471, lot 2KD053, exp 5/1/14.",".","1,638","Siemens has confirmed complaints of low QC and patient recovery with the Dimension Vista(R) LOCI(R) Digoxin(DIGXN) Flex(R) reagent cartridge when calibrating DIGXN with either Drug 4 Cal (KC460) lot 2KD052 or Drug 4 Cal (KC460A) lot 2KD053. Internal testing has shown an average 15% low bias in the therapeutic range of 0.9 to 2.0 ng/mL.",2/21/2013,"02/21/2013",4/24/2013,"04/24/2013"
"Food",64597,"Ongoing","Bay Valley Foods LLC/ TreeHouse Foods, Inc ","Oak Brook","IL","US","Voluntary: Firm Initiated","E-Mail","CA, FL, GA, IL, IN, KY, LA, MD, MI, MS, NY,NC, OH, OK, PA, TN, TX, UT, VA, WA, WI.","F-1191-2013","Class II","55613130643 Our Specialty Linguini & Parmesan, Linguini pasta with naturally flavored Parmesan & Romano Cheese Sauce Mix, Net WT 5.8 oz ( 164g), UPC 0 55049 00602 5, Distributed by S.T. Specialty Foods, Inc, Brooklyn Park, MN 55455. ","Batch77A02072, 77A04232, 77A04242, 77A04252, 77A07222, 77A08072, 77A09172, 77A09262, 77A09272, 77A09282, 77A10161, 77A10162. ",,"390,096 cases (12 cartons per case)","Bay Valley Foods is voluntarily recalling approximately 430,227 cases of boxed pasta mix products manufactured by its subsidiary STP Specialty Foods, Inc. because the labeling did not include soy lecithin in the ingredient statement.",3/1/2013,"03/01/2013",3/20/2013,"03/20/2013"
"Food",64597,"Ongoing","Bay Valley Foods LLC/ TreeHouse Foods, Inc ","Oak Brook","IL","US","Voluntary: Firm Initiated","E-Mail","CA, FL, GA, IL, IN, KY, LA, MD, MI, MS, NY,NC, OH, OK, PA, TN, TX, UT, VA, WA, WI.","F-1189-2013","Class II","55613210946 Western Family, Easy Sides, Herb & Butter Pene, Net WT 5.5 oz (156 g), UPC ''0 15400 12655 7'', Proudly Distributed by Western Family Foods, Inc., P.O. Box 4057, Portland OR, 97208","77A03192, 77A04262, 77B08042, 77B09252.",,"1102 cases (12 cartons per case)","Bay Valley Foods is voluntarily recalling approximately 430,227 cases of boxed pasta mix products manufactured by its subsidiary STP Specialty Foods, Inc. because the labeling did not include soy lecithin in the ingredient statement.",3/1/2013,"03/01/2013",3/20/2013,"03/20/2013"
"Food",64597,"Ongoing","Bay Valley Foods LLC/ TreeHouse Foods, Inc ","Oak Brook","IL","US","Voluntary: Firm Initiated","E-Mail","CA, FL, GA, IL, IN, KY, LA, MD, MI, MS, NY,NC, OH, OK, PA, TN, TX, UT, VA, WA, WI.","F-1190-2013","Class II","556132100582 Meijer, Angel Hair Pasta with Herbs Angel Hair Pasta with Creamy Herb Sauce Mix , Net WT 4.8 oz ( 136g), UPC 7 19283 73636 95, Dist. by Meijer Distribution Inc., Grand Rapids, MI 49544. ","77A02032, 77A02222, 77A03092, 77A07192.",,"2867 cases (12 cartons per case)","Bay Valley Foods is voluntarily recalling approximately 430,227 cases of boxed pasta mix products manufactured by its subsidiary STP Specialty Foods, Inc. because the labeling did not include soy lecithin in the ingredient statement.",3/1/2013,"03/01/2013",3/20/2013,"03/20/2013"
"Food",64597,"Ongoing","Bay Valley Foods LLC/ TreeHouse Foods, Inc ","Oak Brook","IL","US","Voluntary: Firm Initiated","E-Mail","CA, FL, GA, IL, IN, KY, LA, MD, MI, MS, NY,NC, OH, OK, PA, TN, TX, UT, VA, WA, WI.","F-1192-2013","Class II","55613205218 Pasta on the Side, Angel Hair Pasta with Herbs, Net WT 4.8 oz ( 136g), UPC 0 51933 08275 5, Distributed by Save- A- Lot Food Stores LTD, Earth City, MO 63045.","77A01023, 77A01173, 77A02022, 77A02053, 77A02102, 77A02162, 77A03142, 77A03282, 77A04182, 77A06062, 77A06232, 77A07072, 77A07182, 77A08132, 77A08202, 77A09132, 77A09222, 77A09242, 77A10052, 77A10082, 77A10312, 77A11012. ",,"35028 cases (12 cartons per case)","Bay Valley Foods is voluntarily recalling approximately 430,227 cases of boxed pasta mix products manufactured by its subsidiary STP Specialty Foods, Inc. because the labeling did not include soy lecithin in the ingredient statement.",3/1/2013,"03/01/2013",3/20/2013,"03/20/2013"
"Veterinary",64598,"Ongoing","BRAVO! LLC","Vernon","CT","US","Voluntary: Firm Initiated","Letter","Nationwide","V-302-2013","Class I","Bravo! Raw Food Diet Chicken Blend for Dogs and Cats, 2lb. tube, frozen Product Code: 21-102","Batch ID Code / Production Code Date 6_14_12 on white tag attached to the bottom of the plastic film tube. Expanded Recall: Best Used By 3_21_15. ",,"230 cases (15x2lb) Code: 6_14_12 and 67 cases code 3_21_15","Product contaminated with salmonella",3/13/2013,"03/13/2013",9/4/2013,"09/04/2013"
"Veterinary",64598,"Ongoing","BRAVO! LLC","Vernon","CT","US","Voluntary: Firm Initiated","Letter","Nationwide","V-303-2013","Class I","Bravo! Raw Food Diet Chicken Balance For Dog and Cats, 5 lb bags, frozen Product Code: 21-405","Best Used By'' dates of 3_6_15 and 3_12_15 imprinted on the side of the plastic casing. ",,"62 cases","Potential for Product to be contaminated with salmonella",3/13/2013,"03/13/2013",9/4/2013,"09/04/2013"
"Veterinary",64598,"Ongoing","BRAVO! LLC","Vernon","CT","US","Voluntary: Firm Initiated","Letter","Nationwide","V-304-2013","Class I","Bravo!.Raw Food Diet Beef Blend Burgers For Dog and Cats, 5 lb bags, frozen Product Code: 51-508","Best Used By 3_21_15 and 3_22_15 imprinted on the back panel of the plastic bag. (Batch ID and Use by Dates are the same) ",,"102 bags","Potential for Product to be contaminated with salmonella",3/13/2013,"03/13/2013",9/4/2013,"09/04/2013"
"Food",64599,"Ongoing","Whole Foods Market","Austin","TX","US","Voluntary: Firm Initiated","Other","TX","F-1268-2013","Class I","Sonoma Mock Chix Salad Ingredients: Dist. by Whole Foods Market 525 N. Lamar Blvd, Austin, TX 78703. Product is made in store and sold under the name of Sonma Mock Chix Salad. It comes in 6oz, 8oz, 16oz, and 24oz clear plastic hinged containers.","There are no lot numbers for the product, it is produced and packaged at the store level. The product was produced on 02/27/13, packaged on 02/28/13 with a best-by date of 03/06/13. It was then removed from the store's shelves on 3/02/13. ",,"6.05 lbs","The product is being recalled due to undeclared pecans.",3/2/2013,"03/02/2013",4/3/2013,"04/03/2013"
"Food",64600,"Terminated","The TJX Companies, Inc.","Framingham","MA","US","Voluntary: Firm Initiated","E-Mail","Nationwide distribution: Arizona, California, Florida, Idaho, Nevada, New Mexico, North Carolina, Oregon, Puerto Rico, South Carolina, Texas, Virginia, and Washington.","F-1284-2013","Class III","Mrs. Bridges Scottish Raspberry Preserve (''Jam''); Net Wt. 42g /1.5oz; service size 15g; servings per package: 2.8; ID 3779300377 Manufactured for: Kimm & Miller (UK) Ltd. mille Road, Bedford, MK429TW. United Kingdom; Manufacturer: Mackays Ltd., James Chalmers Road, Kirkton Ind Estate, Arbroath, Scotland UK DD113LR. ","L4 0110 20 APR 2014",".",,"The firm is initiating the recall for Scottish Raspberry Preserve due to discovery of contaminants.",4/14/2011,"04/14/2011",4/10/2013,"04/10/2013"
"Devices",64601,"Ongoing","Leica Microsystems (Schweiz) Ag","Heerbrugg",,"CH","Voluntary: Firm Initiated","Visit","Worldwide distribution: USA (Nationwide) including states of: AK, CA, CO, NY, and OR; and countries of: Belarus, China, Hong Kong, India, Indonesia, Italy, Norway, South Africa, Spain, Sweden, Turkey, and Vietnam.","Z-2176-2013","Class II","Surgical microscope The device is used to improve the visibility of objects through magnification and illumination and can be applied for observation and documentation and for human veterinary medical treatment.","Serial Numbers: OH4-84712, OH4-84812, OH4-84912",".","5 units","The brake in the Z axis and/or brakes in the AB and C axes failed during installation.",12/18/2012,"12/18/2012",9/18/2013,"09/18/2013"
"Devices",64601,"Ongoing","Leica Microsystems (Schweiz) Ag","Heerbrugg",,"CH","Voluntary: Firm Initiated","Visit","Worldwide distribution: USA (Nationwide) including states of: AK, CA, CO, NY, and OR; and countries of: Belarus, China, Hong Kong, India, Indonesia, Italy, Norway, South Africa, Spain, Sweden, Turkey, and Vietnam.","Z-2177-2013","Class II","Surgical microscope The device is used to improve the visibility of objects through magnification and illumination and can be applied for observation and documentation and for human veterinary medical treatment.","Serial Numbers: OH5-45912, OH5-46012, OH5-46112, OH5-46212, OH5-46312, OH5-46412, OH5-46512, OH5-46612, OH5-46712, OH5-46912, OH5-47012, OH5-47112, OH5-47212, OH5-47312, OH5-47412, OH5-47512, OH5-47612, OH5-47812, OH5-47912, OH5-48012, OH5-48112, OH5-48212, OH5-48312, OH5-48312 ",".","28 units","The brake in the Z axis and/or brakes in the AB and C axes failed during installation.",12/18/2012,"12/18/2012",9/18/2013,"09/18/2013"
"Biologics",64602,"Terminated","Hoxworth Blood Center UC Medical Center","Cincinnati","OH","US","Voluntary: Firm Initiated","Telephone","OH","B-1507-13","Class II","Red Blood Cells Leukocytes Reduced","W037712085626",".","1 unit","Blood product, which was collected from a donor who traveled to a malarial endemic area, was distributed.",11/26/2012,"11/26/2012",7/10/2013,"07/10/2013"
"Biologics",64603,"Terminated","Blood Systems, Inc","Albuquerque","NM","US","Voluntary: Firm Initiated","FAX","NM","B-1510-13","Class II","Platelets Pheresis Leukocytes Reduced","W041212081657X",".","1 unit","Blood product, which did not meet the acceptable product specifications, was distributed.",1/26/2013,"01/26/2013",7/10/2013,"07/10/2013"
"Drugs",64604,"Ongoing","Zydus Pharmaceuticals USA Inc","Pennington","NJ","US","Voluntary: Firm Initiated","Letter","Nationwide.","D-202-2013","Class II","Venlafaxine Hydrochloride Tablets, 75 mg*, 100-count tablets per bottle, Rx only, Manufactured by: Cadila Healthcare Ltd., Ahmedabad, India; Distributed by: Zydus Pharmaceuticals USA Inc., Pennington, NJ 08534, NDC 68382-021-01.","Lot #: MM8490, Exp 09/14",,"13,320 bottles","Failed Tablet/Capsule Specifications: Pharmacist complaint of an excessive amount of broken and/or chipped tablets in the bottle. ",3/5/2013,"03/05/2013",4/3/2013,"04/03/2013"
"Food",64605,"Ongoing","Ozone Confection & Bakers Supply Co.","Elmwood Park","NJ","US","Voluntary: Firm Initiated","Telephone","Florida, New Jersey, Pennsylvania, Massachusets and New Hampshire and Maryland.","F-1345-2013","Class II","Easter Mix Non-Pareil Seeds; Ozone Confectioners, Elmwood Park, New Jersey 07407. Non-Pareil Seeds, 10 LBS. Net","distributed between 8/2012 and 3/1/2013.",".","481","Undeclared FD&C Colors Yellow #5, Yellow #6, Red #3, Red #40, Blue #1 and Blue #2.",3/7/2013,"03/07/2013",5/1/2013,"05/01/2013"
"Food",64605,"Ongoing","Ozone Confection & Bakers Supply Co.","Elmwood Park","NJ","US","Voluntary: Firm Initiated","Telephone","Florida, New Jersey, Pennsylvania, Massachusets and New Hampshire and Maryland.","F-1343-2013","Class II","Assorted Non-Pareil Seeds; Ozone Confectioners, Elmwood Park, New Jersey 07407. Non-Pareil Seeds, 10 LBS. Net","distributed between 8/2012 and 3/1/2013.",".","481 boxes (net wt 10 Lbs.)","Undeclared FD&C Colors Yellow #5, Yellow #6, Red #3, Red #40, Blue #1 and Blue #2.",3/7/2013,"03/07/2013",5/1/2013,"05/01/2013"
"Food",64605,"Ongoing","Ozone Confection & Bakers Supply Co.","Elmwood Park","NJ","US","Voluntary: Firm Initiated","Telephone","Florida, New Jersey, Pennsylvania, Massachusets and New Hampshire and Maryland.","F-1344-2013","Class II","Harvest Mix Non-Pareil Seeds; Ozone Confectioners, Elmwood Park, New Jersey 07407. Non-Pareil Seeds, 10 LBS. Net","distributed between 8/2012 and 3/1/2013.",".","481","Undeclared FD&C Colors Yellow #5, Yellow #6, Red #3, Red #40, Blue #1 ",3/7/2013,"03/07/2013",5/1/2013,"05/01/2013"
"Food",64606,"Terminated","Doctors Best Weight Loss","Pembroke Pines","FL","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Canada","F-1270-2013","Class I","ProtiDiet High Protein Chocolate Dream Bar","UPC 6 21498 42238 1, lot code CR 18 13B, and Best Before: 2015-08. ",,"3 boxes (21 bars in total)","Recall was initiated after CFIA notified FDA of implicated products sold to the firm. During a FDA visit, the firm discovered that they were selling product that were recalled in Canada by the manufacturer, ''Pro-Amino International Inc.'' because it may be contaminated with Salmonella. Upon further FDA investigation at the firm product was further distributed to a consignee in Canada.",3/8/2013,"03/08/2013",4/3/2013,"04/03/2013"
"Drugs",64607,"Ongoing","Teva Pharmaceuticals USA, Inc.","Sellersville","PA","US","Voluntary: Firm Initiated","Letter","Nationwide","D-246-2013","Class III","Jolessa (levonorgestrel/ethinyl estradiol) Tablets, 0.15 mg/0.03 mg, 91-count tablets per extended-cycle tablet dispenser packaged in 3 dispensers per carton, Rx only, Manufactured By: Barr Laboratories, Inc., Pomona, NY 10970; Manufactured For: Teva Pharmaceuticals USA, Sellersville, PA 18960, NDC 0555-9123-66.","Lot #: 33803603A, 33803604A, Exp 11/13; 33803996A, and 33803997A, Exp 03/14",,"71,893 dispensers","Failed Tablet/Capsule Specifications: This recall is being carried out due to an out of specification result for appearance.",3/12/2013,"03/12/2013",4/17/2013,"04/17/2013"
"Drugs",64607,"Ongoing","Teva Pharmaceuticals USA, Inc.","Sellersville","PA","US","Voluntary: Firm Initiated","Letter","Nationwide","D-245-2013","Class III","Portia (levonorgestrel and ethinyl estradiol) Tablets, USP, 0.15 mg/0.03 mg, 28-count tablets (containing 21 pink tablets followed by 7 white tablets) per blister card packaged in 6 blister cards per carton, Rx only, Barr Laboratories, Inc., Pomona, NY 10970, NDC 0555-9020-58.","Lot #: 33801951A, and 33802189A, Exp 03/13",,"17,661 blister cards","Failed Tablet/Capsule Specifications: This recall is being carried out due to an out of specification result for appearance.",3/12/2013,"03/12/2013",4/17/2013,"04/17/2013"
"Drugs",64608,"Ongoing","Teva Pharmaceuticals USA, Inc.","Sellersville","PA","US","Voluntary: Firm Initiated","Letter","Nationwide","D-496-2013","Class III","Seasonale(R) (Levonorgestrel/Ethinyl Estradiol Tablets), 0.15 mg/0.03 mg, 3 extended-cycle tablet dispensers, 91 tablets each, Rx only, TEVA Women Health, Inc., Subsidiary of TEVA Pharmaceuticals USA, Inc., Sellersville, PA NDC 51285-058-66","NDC 51285-058-66 -- lot numbers 33802330A, exp 6/2013; and 33802464A, exp 6/2013.",".","17,108 blister packs","Failed Impurity/Degradation Specification; an impurity identified as N-Butyl-Benzene Sulfonamide (NBBS) detected during impurity testing ",3/14/2013,"03/14/2013",6/5/2013,"06/05/2013"
"Drugs",64608,"Ongoing","Teva Pharmaceuticals USA, Inc.","Sellersville","PA","US","Voluntary: Firm Initiated","Letter","Nationwide","D-497-2013","Class III","Camrese(TM) (Levonorgestrel/Ethinyl Estradiol Tablets), 0.15 mg/0.03 mg and Ethinyl Estradiol 0.01 Tablets, 2 Extended-Cycle Tablet Dispensers (NDC 0093-3134-82) and 1 Extended-Cycle Tablet Dispenser NDC 0093-3134-91), 91 Tablets Each, Rx only, TEVA Womens Health Inc., Subsidiary of TEVA Pharmaceuticals, Inc., Sellersville, PA","NDC 0555-3134-82 and 0093-3134-91 -- lot numbers 33802566A, exp 3/2013; 33802967A, exp 8/2013; 33803529A, exp 10/2013; and 33803609A, exp 11/2013.",".","120,049 blister packs","Failed Impurity/Degradation Specifications; an impurity identified as N-Butyl-Benzene Sulfonamide (NBBS) detected during impurity testing ",3/14/2013,"03/14/2013",6/5/2013,"06/05/2013"
"Devices",64609,"Ongoing","Advanced Sterilization Products","Irvine","CA","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution-USA (nationwide) and the countries of Egypt, Germany, Italy, France, Saudi Arabia, UAE, Japan, Singapore, China, Thailand, Hong Kong, Hungary, Israel, Slovania, Poland, Czech Republic, Taiwan, Sweden, Greece, Korea, Ireland, and United Kingdom.","Z-0998-2013","Class II","STERRAD 200 System Carriage, P/N 10208. Used as a tool to expedite loading and unloading processed items from a STERRAD 200 sterilizer.","N/A",,"2,457 units","Advanced Sterilization Products (ASP) is recalling the STERRAD 200 System Carriage because it can potentially become dislodged when an excessive load is applied.",3/13/2012,"03/13/2012",4/3/2013,"04/03/2013"
"Devices",64610,"Ongoing","Siemens Healthcare Diagnostics, Inc","East Walpole","MA","US","Voluntary: Firm Initiated","Letter","Nationwide Distribution.","Z-1119-2013","Class II","ADVIA Centaur Vitamin D Assay (100 tests); Reference Number: 10491994. For use in the quantitative determination of Vit D. ","Ready Pack Lot Number: 134009 Kit Lot Number/Exp. Date: 88766009 4/28/2013 88786009 4/28/2013 89198009 4/28/2013 Ready Pack Lot Number: 134010 Kit Lot Number/Exp. Date: 90671010 6/2/2013 92212010 6/2/2013 Ready Pack Lot Number: 134011 Kit Lot Number/Exp. Date: 92395011 8/12/2013 94660011 8/12/2013 95016011 8/12/2013 95313011 8/12/2013",".","3871 ","Negative bias in patient samples for Vitamin D ",3/13/2013,"03/13/2013",4/24/2013,"04/24/2013"
"Devices",64610,"Ongoing","Siemens Healthcare Diagnostics, Inc","East Walpole","MA","US","Voluntary: Firm Initiated","Letter","Nationwide Distribution.","Z-1121-2013","Class II","ADVIA Centaur Vitamin D Calibrator 2-pack; Reference Number:10493589. For use in the quantitative determination of Vit D. ","Lot Number: C3410 Kit Lot Number/Exp. Date: 95197A10 8/16/2013 95031A10 8/16/2013 94607A10 8/16/2013 94155A10 8/16/2013 ",".","372 pk Cals","Negative bias in patient samples for Vitamin D ",3/13/2013,"03/13/2013",4/24/2013,"04/24/2013"
"Devices",64610,"Ongoing","Siemens Healthcare Diagnostics, Inc","East Walpole","MA","US","Voluntary: Firm Initiated","Letter","Nationwide Distribution.","Z-1120-2013","Class II","ADVIA Centaur Vitamin D Assay (500 tests); Reference Number:10631021. For use in the quantitative determination of Vit D. ","Ready Pack Lot Number: 134009 Kit Lot Number/Exp. Date: 88767009 4/28/2013 88787009 4/28/2013 Ready Pack Lot Number: 134010 Kit Lot Number/Exp. Date: 90253010 6/2/2013 91934010 6/2/2013 Ready Pack Lot Number: 134011 Kit Lot Number/Exp. Date: 92396011 8/12/2013 93363011 8/12/2013 95088011 8/12/2013",".","4133","Negative bias in patient samples for Vitamin D ",3/13/2013,"03/13/2013",4/24/2013,"04/24/2013"
"Devices",64610,"Ongoing","Siemens Healthcare Diagnostics, Inc","East Walpole","MA","US","Voluntary: Firm Initiated","Letter","Nationwide Distribution.","Z-1122-2013","Class II","ADVIA Centaur Vitamin D Calibrator 6-pack; Reference Number:10630911. For use in the quantitative determination of Vit D. ","Lot Number: C3410 Kit Lot Number/Exp. Date: 95010A10 8/16/2013",".","107 6pk Cals","Negative bias in patient samples for Vitamin D ",3/13/2013,"03/13/2013",4/24/2013,"04/24/2013"
"Biologics",64612,"Terminated","Blood Assurance Inc","Chattanooga","TN","US","Voluntary: Firm Initiated","FAX","TN, NY","B-1509-13","Class III","Blood and Blood Products for Reprocessing","P67796",".","1 unit","Blood products, collected from a donor in which donor suitability was not adequately determined, were distributed.",2/20/2013,"02/20/2013",7/10/2013,"07/10/2013"
"Biologics",64612,"Terminated","Blood Assurance Inc","Chattanooga","TN","US","Voluntary: Firm Initiated","FAX","TN, NY","B-1508-13","Class II","Red Blood Cells Leukocytes Reduced","P67796",".","1 unit","Blood products, collected from a donor in which donor suitability was not adequately determined, were distributed.",2/20/2013,"02/20/2013",7/10/2013,"07/10/2013"
"Biologics",64613,"Terminated","Talecris Plasma Resources Inc","Monroe","LA","US","Voluntary: Firm Initiated","FAX","North Carolina","B-1525-13","Class III","Source Plasma","3800245198; 3800245032 ",".","2 units","Blood products, collected from a donor in which donor suitability was not adequately determined, were distributed.",1/16/2013,"01/16/2013",7/10/2013,"07/10/2013"
"Food",64614,"Ongoing","New Chapter, Inc.","Brattleboro","VT","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","AK, AZ, CA, CO, CT, DC, FL, GA, HI, IA, ID, IL, KS, LA, MA, MD, ME, MI, MN, MO, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OR, PA, SD, TN, TX, UT, VT, WA, WI","F-1299-2013","Class I","NewChapter Probiotic Elderberry, 90 vegetarian capsules bottle.Dietary Supplement UPC: 7-27783-00123-8","Lot: 01230049332Expiration date: 01/31/15 (located on the bottom of the box and on the side of the bottle) ",,"1,004 bottles","The product may contain an undeclared allergen soy",3/13/2013,"03/13/2013",4/17/2013,"04/17/2013"
"Food",64615,"Ongoing","Nashua Nutrition","Nashua","NH","US","Voluntary: Firm Initiated","E-Mail","Internet sales. Nationwide.","F-1303-2013","Class I","Proti Diet High Protein Chocolate Dream Bar, is sold in 210 g packages (7 bars per package) UPC 6 21498 42238 1","Lot code CR 18 13B, and Best Before: 2015-08. ",,"199","Product may be contaminated with Salmonella",3/11/2013,"03/11/2013",4/17/2013,"04/17/2013"
"Food",64617,"Ongoing","Pan -O- Gold Baking Co","Saint Cloud","MN","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","IL, IN, IA, MN, MT, NE, ND, SD, WI.","F-1239-2013","Class II","Rye bread with the following brands: Village Hearth , Rye Cottage Bread, NET WT 24 OZ ( 1 LB 8OZ) (680g) , East Coast Caraway Rye, NET WT 20 OZ (1 LB 4 OZ (567g) , PAN-O-GOLD VILLAGE HEARTH BAKER ST, ST. CLOUD, MN 56302. Cub Foods, Deli Rye, NET WT 16 OZ (1 LB) 454 g, Distributed by SUPERVALU INC., Eden prairie, MN 55344. Essential Everyday, Deli Rye Bread, NET WT 16 OZ (1 LB) 454 g Distributed by Supervalu Inc., Eden Prairie, MN 55344, Flvorite, Deli Rye, NET WT 16 OZ (1 lb) 454 g, Distributed by SUPERVALU INC., Eden prairie, MN 55344. Family Choice, Northern Rye Bread, NET WT 16OZ (1 LB) (454G), Seeded Bye Bread, NET WT 20 OZ (1 LB 4 OZ) (567g), Unseeded Rye Bread, NET WT 20 OZ (1 LB 4 OZ) (567g), PAN-O-GOLD VILLAGE HEARTH BAKER ST, ST. CLOUD, MN 56302. Piggly Wiggly, Rye, Seeded Caraway Rye, NET WT 20 OZ (1LB 4 OZ) 568g., distributed by Piggly Wiggly LLC, Keene, NH 03431. Food Club, Rye, NET WT 16 OZ (1 LB) 454g., Distributed by Topco Associates LLC, 7711 Gross Point Road, Skokie, ILL 60077. Shurfresh, Rye, Seeded Rye, Unseeded Rye, NET WT 16 OZ (1LB) 454g & 20 OZ (1LB 4 OZ) 567g., Distributed by Topco Associates LLC, 7711 Gross Point Road, Skokie, ILL 60077. ","Feb 12 P1..., Feb 12 P3..., Feb 13 P1..., Feb 13 P3..., Feb 14 P1..., Feb 14 P3..., Feb 15 P1..., Feb 15 P3...,Feb 16 P1..., Feb 16 P3...,Feb 17 P1..., Feb 17 P3..., Feb 18 P1..., Feb 18 P3..., Feb 19 P1...,Feb 19 P3... ",".","8274 loaves","A recall has been initiated by Pan-O-Gold Baking Co. after they were notified by Dakota Specialty Milling of a potential foreign material (stainless steel wire from disintegrated sifter screen) risk to the rye flour Pan O Gold uses as an ingredient in all of their rye breads.",2/6/2013,"02/06/2013",3/27/2013,"03/27/2013"
"Devices",64618,"Ongoing","Unimed Surgical Products, Inc.","Largo","FL","US","Voluntary: Firm Initiated","Letter","Distributed in the states of MO, TN, and PA.","Z-1347-2013","Class II","PROGRESSIVE MEDICAL Laparoscopic Electrode PTFE Coated L Hook 33cm. Intended for the cutting of soft tissue and coagulation.","Lot Numbers: 071212-02, 071212-03, 071212-05, 071212-01, 071212-06, 082712-02, 071212-04, 082712-04, 082712-05, 082712-13, 071212-07, 082712-07, 082712-09, 082712-03, 082712-15, 082712-14, 081712-06, 082712-01, 082712-10, 081512-06, 080612-01, 081512-07, 082712-12, 081512-04, 082712-11, 081012-01, 080612-03, 080612-02, 080612-04, 071612-05, 071612-04, 080612-05, 080612-07, 081312-11, 071612-03, 081312-10, 071912-01, 071912-02, 092812-02, 092812-03, 092812-04, 092812-05, 092812-06, 092812-07, 091312-01, 100812-02, 072312-01, 080612-08, 081312-01, 100112-01, 091312-04, 082312-04, 082312-03, 082312-06, 082312-05, 082812-02, 111212-01, 111212-03, 111212-02, 082312-02, 092812-02, 092812-07, 092812-06, 111212-19, 111212-18, 111212-18, 111212-19, 100212-01, 100312-06, 111212-11, 111212-07, 081512-05, 111212-04, 100312-01, 100312-03, 091312-02, 091312-03, 100312-08, 100312-09, 100312-10, 100312-01, 100312-03, 100312-04, 111212-14, 111212-10, 111212-08, 111212-07, 111212-17, 111212-20, 111212-21, 121012-03, 120612-01, 111212-12, 121012-01, 112112-01, 112112-02, 112112-03, 112112-04, 112112-06, 011113-04, 100312-02, 011013-10, 092812-01, 091912-02, 100312-05, 011013-12, 011013-05, 092812-02, 111212-16, 011013-04, 011013-07, 011013-08, 100312-13, 011013-02, 111212-09, 111212-11, 011013-11, 111212-13, 111212-15, 092812-03, 012213-02, 111212-12, 011013-13, 012213-01, 012213-04 011013-09, 011413-02, 012213-03, 011413-03, 011413-04, 111212-16, 011013-06, 012913-01, 012913-02, 111212-05, 012913-03, 012913-09, 012813-01. ",".","120,416 units","Firm is recalling due to concerns regarding changes that were made to the PTFE coating materials. ",2/15/2013,"02/15/2013",5/29/2013,"05/29/2013"
"Drugs",64619,"Ongoing","Palmer Natural Products","Star","ID","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Florida, Idaho, California and Hong Kong. This product can be ordered on line.","D-232-2013","Class II","Aniracetam and Choline, Aniracetam 460 mg, Choline 76 mg, 180 capsules per bottler, non-Rx, distributed by BoostYourGrade, BoostYourGrade, LLC Orlando, FL ","All lot codes. ",".","250 bottles","Marketed Without an Approved NDA/ANDA: The products are unapproved drugs",3/11/2013,"03/11/2013",4/10/2013,"04/10/2013"
"Drugs",64619,"Ongoing","Palmer Natural Products","Star","ID","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Florida, Idaho, California and Hong Kong. This product can be ordered on line.","D-233-2013","Class II","Piracetam & Choline, 390mg Piracetam 104mg Choline Capsules, a) 30 count bottle, b) 100 count bottle, OTC, BoostYourGrade, LLC, Orlando, FL. 32826 , ","All lot codes. ",".","511 30 count bottles, 4103 100 count bottles","Marketed Without an Approved NDA/ANDA: The products are unapproved drugs",3/11/2013,"03/11/2013",4/10/2013,"04/10/2013"
"Drugs",64619,"Ongoing","Palmer Natural Products","Star","ID","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Florida, Idaho, California and Hong Kong. This product can be ordered on line.","D-230-2013","Class II","Aniracetam & Choline capsules, 430mg Aniracetam 88mg Choline, a) 30 count bottle b) 60 count bottle, c) 90 count, d) 180 count , OTC, BoostYourGrade, LLC Orlando, FL 32826","All lot codes. ",".","557 30 count botles, 672 60 count bottles, 1,102 90 count bottles, 250 180 count bottles","Marketed Without an Approved NDA/ANDA: The products are unapproved drugs",3/11/2013,"03/11/2013",4/10/2013,"04/10/2013"
"Drugs",64619,"Ongoing","Palmer Natural Products","Star","ID","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Florida, Idaho, California and Hong Kong. This product can be ordered on line.","D-234-2013","Class II","Brain Defogger, Piracetam 390mg Choline 104mg capsules, 100 count bottle, OTC, BoostYourGrade, LLC, Orlando, FL. . ","All lot codes. ",".","4103 bottles","Marketed Without an Approved NDA/ANDA: The products are unapproved drugs",3/11/2013,"03/11/2013",4/10/2013,"04/10/2013"
"Drugs",64619,"Ongoing","Palmer Natural Products","Star","ID","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Florida, Idaho, California and Hong Kong. This product can be ordered on line.","D-235-2013","Class II","BoostYourGrade.com, Piracetam 390mg Choline 104mg capsules, 250 count bottle, OYC, BoostYourGrade, LLC, Orlando, FL 32826 ","All lot codes.",".","723 bottles","Marketed Without an Approved NDA/ANDA: The products are unapproved drugs",3/11/2013,"03/11/2013",4/10/2013,"04/10/2013"
"Drugs",64619,"Ongoing","Palmer Natural Products","Star","ID","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Florida, Idaho, California and Hong Kong. This product can be ordered on line.","D-231-2013","Class II","NOOTROPA COGNITIVE ENHANCEMENT SUPPLEMENT, 400 mg Aniracetam Capsules 60 count bottle, OTC Manufactured & Packaged in the USA for NOOTROPA.COM. DEVELOPED BY: Digital Superfuture Limited Arntel Building 9B 148 Des Voeux Rd. Hong Kong.","Lot HJLA, ",".","672 bottles","Marketed Without an Approved NDA/ANDA: The products are unapproved drugs",3/11/2013,"03/11/2013",4/10/2013,"04/10/2013"
"Drugs",64619,"Ongoing","Palmer Natural Products","Star","ID","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Florida, Idaho, California and Hong Kong. This product can be ordered on line.","D-236-2013","Class II","Oxiracetam & Choline , Oxiracetam 460mg Choline 110mg capsules a) 30 count bottle, b) 60 count bottle, c) 90 count bottle, OTC, BoostYourGrade, LLC, Orlando, FL. 32826 ","All lot codes ",".","472 - 30 count bottles; 203 - 60 count bottles; 458 - 90 count bottles","Marketed Without an Approved NDA/ANDA: The products are unapproved drugs",3/11/2013,"03/11/2013",4/10/2013,"04/10/2013"
"Devices",64620,"Ongoing","Medtronic Inc. Cardiac Rhythm Disease Management","Saint Paul","MN","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution-USA including the states of FL, OH, and MN and the countries of Belgium, France Germany, Netherlands, Turkey, and United Kingdom.","Z-1017-2013","Class II","Medtronic Archer Super Stiff Guidewire 0.035 inch (0.89mm), Model ARCSJ200W. Intended to facilitate catheter placement and exchange during procedures in the aorta.","Lot number GFWA0387",,"225 units","Medtronic has identified an issue with a specific lot of the Archer 0.035 inch (0.89mm) Super Stiff Guidewire, model ARCSJ200W, where the PTFE (Teflon) coating has the potential to separate from the wire during in-vivo use. ",3/13/2013,"03/13/2013",4/3/2013,"04/03/2013"
"Devices",64621,"Terminated","Discus Dental LLC","Culver City","CA","US","Voluntary: Firm Initiated","Letter","Nationwide Distribution including AL, AZ, CA, CO, FL, GA, IA, ID, IL, IN, KS, MA, MD, MI, MO, MT NH, NJ, NM, NV, NY, OH, PA, SD, TX, UT, VA, and WA.","Z-1186-2013","Class II","SL3 SOFT-TISSUE Laser (Model LR2002); Manuf: Discus Dental, LLC, 8550 Higuera Street, Culver City CA 90232. The SL3 is a soft-tissue diode laser intended to be used for dental procedures","Model LR2002",,"150 units","The firm is initiating this recall of the SL3 Soft Tissue Laser equipped with a fiber optic Unifiber system which contains a fragile glass filament because the fiber broke near the hand piece.",7/21/2011,"07/21/2011",5/8/2013,"05/08/2013"
"Food",64622,"Ongoing","Schwan's Corporate One Building HS/FS","Marshall","MN","US","Voluntary: Firm Initiated","Telephone","Continental USA (Schwan's Home Service, Inc., distributed to Residential customers)","F-1272-2013","Class II","LiveSmart Bruschetta Pizza #661, Contains 2 - 6.30 OZ PIZZAS, net WT 12.60 oz (357 G), UPC 631488, Distributed by Schwan's Home Service, Marshall, MN 56258, ","Date codes: 312244xxxx, 312286xxxx & 312349XXXX.",,"6770 cases (9 per case)","Schwan's is conducting a recall because they were informed by one of their flour suppliers, Dakota Specialty Milling, Inc., that a limited number of its flours and grains blends are being recalled due to the possible presence of fragments of thin metal wire from a defective screen on one of its manufacturing lines. As a precautionary measure, Schwan's has chosen to voluntarily recall Schwan's LiveSmart'' Bruschetta Pizza #661 after being notified by Dakota Specialty Milling of their recall.",2/22/2013,"02/22/2013",4/3/2013,"04/03/2013"
"Devices",64623,"Ongoing","Medtronic Inc. Cardiac Rhythm Disease Management","Saint Paul","MN","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution - USA (nationwide) including Puerto Rico and the countries of: Argentina, Armenia, Australia, Austria, Belgium, Bolivia, Canada, Chile, China, Colombia, Croatia, Czech Republic, Ecuador, El Salvador, Estonia, Finland, France, Germany, Greece, Hong Kong, Hungary, Iceland, India, Indonesia, Iran, Israel, Italy, Jordan, Korea, Kuwait, Latvia, Lebanon, Libya, Malaysia, Montenegro, Morocco, Netherlands, New Zealand, Norway, Oman, Philippines, Poland, Portugal, Russian Federation, Saudi Arabia, Serbia, Singapore, Slovakia, South Africa, Spain, Sweden, Switzerland, Taiwan, Thailand, Turkey, United Kingdom, Venezuela, Viet Nam.","Z-1019-2013","Class II","Medtronic Archer 0.035 inch (0.89mm) Super Stiff Guidewire, Models ARCSJ200W, ARCSJ260W, and ARCDJ260W. Sterile using ethylene oxide. Product Usage: The Medtronic Archer 0.035 inch (0.89mm) Super Stiff Guidewires are intended to facilitate catheter placement and exchange during diagnostic or interventional procedures in the aorta, where increased support, distal flexibility, and low surface friction of the guidewire is needed. ","Model ARCSJ200W Lot Numbers: GFWC1124, GFWC1506, GFWC2138, GFWC2652, GFWC2653, GFWD0353, GFWD0881, GFWD0882, GFWD2048, GFWD2049, GFWD2050, GFWD2051, GFWD2052, GFWE0743, GFWE0744, GFWE0745, GFWE0746, GFWE0747, GFWE3710, GFWE4272, GFWE4273, GFWE4274, GFWE4275, GFWF0143, GFWF0144, GFWF0147, GFWF0148, GFWF0149, GFWG0428, GFWG0429, GFWG0430, GFWG0431, GFWG0432, GFWG0433, GFWG0434, GFWH0333, GFWH0334, GFWH0335, GFWH0336, GFWH0337, GFWH0338, GFWI0190, GFWI0191, GFWI0192, GFWI0193, GFWI0194, GFWI0195, GFWJ0027, GFWJ0028, GFWJ0029, GFWJ2454, GFWJ2455, GFWJ2456, GFWJ2457, GFWJ2458, GFWK1910, GFWK1911, GFWL0370, GFWL2571, GFWL2572, GFXA0224. Model ARCSJ260W Lot Numbers: GFWC1501, GFWC1502, GFWC1503, GFWD0883, GFWD0884, GFWD3256, GFWE0752, GFWE0753, GFWE3711, GFWF0145, GFWF0150, GFWG0425, GFWG0426, GFWG0427, GFWH0344, GFWH0345, GFWI0201, GFWI0202, GFWI0203, GFWJ0418, GFWJ0419, GFWJ0420, GFWJ2461, GFWJ2462, GFWJ2464, GFWJ2465, GFWL0368, GFWL0369, GFWL0415, GFWL0416, GFXA0219, GFXA0220, GFXA0221, GFXA0222. Model ARCDJ260W Lot Numbers: GFWC1507, GFWC1508, GFWD0885, GFWE0750, GFWE0751, GFWF0142, GFWF0146, GFWG0423, GFWG0424, GFWH0331, GFWH0332, GFWI0186, GFWI0187, GFWI0188, GFWJ2449, GFWJ2450, GFWJ2451, GFWJ2452, GFWK1844. ",,"27,682 devices","Medtronic has identified an issue involving specific lot numbers of the Medtronic Archer 0.035 inch (0.89mm) Super Stiff Guidewire, Models ARCSJ200W, ARCSJ260W, and ARCDJ260W, where a change in the manufacturing process has been identified as the cause for potential kinking and breaking at the proximal weld end of the outer spring coil during in-vivo use. ",3/13/2013,"03/13/2013",4/3/2013,"04/03/2013"
"Devices",64624,"Ongoing","Lifescan Inc","Milpitas","CA","US","Voluntary: Firm Initiated","Letter","USA Nationwide Distribution","Z-1074-2013","Class I","All OneTouch Verio IQ Blood Glucose Meters sold as: Verio IQ System Kits - Meter; Verio IQ Starter kits - Meter; Verio IQ Warranty Meter. Product Usage: The OneTouch VerioIQ Blood Glucose Monitoring System is intended to be used for the quantitative measurement of glucose (sugar) in fresh capillary whole blood samples drawn from the fingertips. The system is intended to be used by a single patient and should not be used for testing multiple patients. The OneTouch VerioIQ Blood Glucose Monitoring System is intended for self-testing outside the body (in vitro diagnostic use) by people with diabetes at home as an aid to monitor the effectiveness of diabetes control. ","Part numbers: Verio IQ Systems Kits: 022 267-01, 022 267-01, 022 267-03; Verio IQ Starter Kits: 022 268 01, 022 268-02; Verio IQ Warranty Kits: 022 275 01, 022 275 02. All lots and serial numbers",".","US 710,413 ","The Verio IQ meter will shut off and revert to set up mode at glucose values above 1023 instead of displaying EXTREME HIGH GLUCOSE.",3/11/2013,"03/11/2013",4/24/2013,"04/24/2013"
"Devices",64625,"Ongoing","Acclarent, Inc.","Menlo Park","CA","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution-USA (nationwide) and the countries of Belgium, Canada, and Saudi Arabia.","Z-1864-2013","Class II","Inspira AIR Balloon Dilation system. Size 12 x 40 mm, Syringe volume 12 cc. Dilation of airway tree.","Product code: BC1240A; All lots manufactured after March 1, 2011",,"1217","Labeling correction for all sizes of the Inspira AIR Balloon Dilation System to include additional language and warnings as well as to clarify some instructional steps.",1/11/2013,"01/11/2013",8/7/2013,"08/07/2013"
"Devices",64625,"Ongoing","Acclarent, Inc.","Menlo Park","CA","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution-USA (nationwide) and the countries of Belgium, Canada, and Saudi Arabia.","Z-1860-2013","Class II","Inspira AIR Balloon Dilation system. Size 5 x 24 mm, Syringe volume 6-8 cc. Dilation of airway tree.","Product code: BC0524A; All lots manufactured after March 1, 2011",,"1920 ","Labeling correction for all sizes of the Inspira AIR Balloon Dilation System to include additional language and warnings as well as to clarify some instructional steps.",1/11/2013,"01/11/2013",8/7/2013,"08/07/2013"
"Devices",64625,"Ongoing","Acclarent, Inc.","Menlo Park","CA","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution-USA (nationwide) and the countries of Belgium, Canada, and Saudi Arabia.","Z-1862-2013","Class II","Inspira AIR Balloon Dilation system. Size 8.5 x 24 mm, Syringe volume 12 cc. Dilation of airway tree.","Product code: BC8524A; All lots manufactured after March 1, 2011",,"625","Labeling correction for all sizes of the Inspira AIR Balloon Dilation System to include additional language and warnings as well as to clarify some instructional steps.",1/11/2013,"01/11/2013",8/7/2013,"08/07/2013"
"Devices",64625,"Ongoing","Acclarent, Inc.","Menlo Park","CA","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution-USA (nationwide) and the countries of Belgium, Canada, and Saudi Arabia.","Z-1866-2013","Class II","Inspira AIR Balloon Dilation system. Size 16 x 40 mm, Syringe volume 12 cc. Dilation of airway tree.","Product code: BC1640A; All lots manufactured after March 1, 2011",,"2175","Labeling correction for all sizes of the Inspira AIR Balloon Dilation System to include additional language and warnings as well as to clarify some instructional steps.",1/11/2013,"01/11/2013",8/7/2013,"08/07/2013"
"Devices",64625,"Ongoing","Acclarent, Inc.","Menlo Park","CA","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution-USA (nationwide) and the countries of Belgium, Canada, and Saudi Arabia.","Z-1863-2013","Class II","Inspira AIR Balloon Dilation system. Size 10 x 40 mm, Syringe volume 12 cc. Dilation of airway tree.","Product code: BC1040A; All lots manufactured after March 1, 2011",,"2703","Labeling correction for all sizes of the Inspira AIR Balloon Dilation System to include additional language and warnings as well as to clarify some instructional steps.",1/11/2013,"01/11/2013",8/7/2013,"08/07/2013"
"Devices",64625,"Ongoing","Acclarent, Inc.","Menlo Park","CA","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution-USA (nationwide) and the countries of Belgium, Canada, and Saudi Arabia.","Z-1865-2013","Class II","Inspira AIR Balloon Dilation system. Size 14 x 40 mm, Syringe volume 12 cc. Dilation of airway tree.","Product code: BC1440A; All lots manufactured after March 1, 2011",,"3324","Labeling correction for all sizes of the Inspira AIR Balloon Dilation System to include additional language and warnings as well as to clarify some instructional steps.",1/11/2013,"01/11/2013",8/7/2013,"08/07/2013"
"Devices",64625,"Ongoing","Acclarent, Inc.","Menlo Park","CA","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution-USA (nationwide) and the countries of Belgium, Canada, and Saudi Arabia.","Z-1861-2013","Class II","Inspira AIR Balloon Dilation system. Size 7 x 24 mm, Syringe volume 6-8 cc. Dilation of airway tree.","Product code: BC0724A; All lots manufactured after March 1, 2011",,"2366","Labeling correction for all sizes of the Inspira AIR Balloon Dilation System to include additional language and warnings as well as to clarify some instructional steps.",1/11/2013,"01/11/2013",8/7/2013,"08/07/2013"
"Food",64626,"Ongoing","Zumbro River Brand, Inc","Albert Lea","MN","US","Voluntary: Firm Initiated","E-Mail","VT and Canada","F-1319-2013","Class II","Ideal Protein, Sea Salt & Vinegar Ridges, 7 packets Net WT 1.4 oz (40 g) each. Total net weight 9.9 oz (280 g). Distributed by Laboratories C.O.P Inc., 60 Jean-Proulx St Gatieau QC Canada J8Z 1W1","SS & Vinegar USA Lot Numbers 10723 18821 10821 22923 10822 23021 10823 23022 10921 23023 10922 23121 10923 23122 14922 32322 15522 32323 15523 32421 15621 32422 15622 32423 15623 32521 15721 32522 15722 32523 18523 18721 18722 18723 SS & Vinegar Canada Lot Numbers 10923 28922 11021 28923 11022 29021 14521 29022 14522 29023 14523 29023 14621 14922 18323 18421 18422 18423 18521 18522 28723 28821 28822 28823 28921 ",".","58,610 lbs","Dakota Specialty Milling informed Zumbro River Brand (ZRB) that they are recalling Multigrain Whole Meal Flour Blend 100 (Multigrain Flour) because of a potential contamination with fine wire pieces. This Multigrain Flour is a component in an extruded base called Whey multigrain Ridges, so these fine wire pieces could be contained in the Whey Muligrain Ridges. The fine wire is too thin to be detected by metal detection, therefore ZRB is recalling the products made with the recalled Multigrain Flour which include Sea Salt & vinegar Ridges and BBQ Ridges (USA & Canada). ",2/7/2013,"02/07/2013",4/24/2013,"04/24/2013"
"Food",64626,"Ongoing","Zumbro River Brand, Inc","Albert Lea","MN","US","Voluntary: Firm Initiated","E-Mail","VT and Canada","F-1320-2013","Class II","Ideal Protein, BBQ Ridges, 7 packets Net WT 1.4 oz (40 g) each. Total net weight 9.9 oz (280 g). Distributed by Laboratories C.O.P Inc., 60 Jean-Proulx St Gatieau QC Canada J8Z 1W1","BBQ USA Lot Numbers 10123 19023 10221 23122 10222 23123 10223 23221 10321 23222 10322 23223 10323 23321 15723 32621 15821 32622 15822 33021 15823 33022 15921 33121 15922 33122 18823 33221 18921 18922 18923 19021 19022 BBQ Canada Lot Numbers 10323 10421 10622 11622 11623 11721 19023 19121 19122 19123 19221 19222 23321 23322 23323 23421 23422 23423 ",".","56,842 lbs","Dakota Specialty Milling informed Zumbro River Brand (ZRB) that they are recalling Multigrain Whole Meal Flour Blend 100 (Multigrain Flour) because of a potential contamination with fine wire pieces. This Multigrain Flour is a component in an extruded base called Whey multigrain Ridges, so these fine wire pieces could be contained in the Whey Muligrain Ridges. The fine wire is too thin to be detected by metal detection, therefore ZRB is recalling the products made with the recalled Multigrain Flour which include Sea Salt & vinegar Ridges and BBQ Ridges (USA & Canada). ",2/7/2013,"02/07/2013",4/24/2013,"04/24/2013"
"Biologics",64627,"Terminated","Community Blood Centers of South Florida, Inc.","Hialeah","FL","US","Voluntary: Firm Initiated","FAX","Florida","B-1484-13","Class II","Red Blood Cells","2320628 ",".","1 unit","Blood products, collected from an inelgible donor, were distributed. ",3/11/2013,"03/11/2013",6/12/2013,"06/12/2013"
"Biologics",64627,"Terminated","Community Blood Centers of South Florida, Inc.","Hialeah","FL","US","Voluntary: Firm Initiated","FAX","Florida","B-1485-13","Class II","Red Blood Cells (Apheresis) Leukocytes Reduced","2476618; 2476618",".","2 units","Blood products, collected from an inelgible donor, were distributed. ",3/11/2013,"03/11/2013",6/12/2013,"06/12/2013"
"Biologics",64628,"Terminated","Community Blood Centers of South Florida, Inc.","Hialeah","FL","US","Voluntary: Firm Initiated","Telephone","Florida","B-1434-13","Class II","Red Blood Cells","W036809153837; ",".","1 unit","Blood product, which was collected from a donor in which donor suitability was not adequately determined, was distributed.",1/23/2013,"01/23/2013",6/5/2013,"06/05/2013"
"Biologics",64629,"Terminated","Community Blood Bank of Lancaster County Medical Society","Lincoln","NE","US","Voluntary: Firm Initiated","FAX","Nebraska","B-1435-13","Class II","Red Blood Cells Leukocytes Reduced","W087909308200; ",".","1 unit","Blood product, which was collected from a donor who traveled to malarial endemic areas, was distributed. ",1/28/2013,"01/28/2013",6/5/2013,"06/05/2013"
"Biologics",64630,"Terminated","Florida's Blood Centers, Inc.","Orlando","FL","US","Voluntary: Firm Initiated","Letter","Florida","B-1436-13","Class II","Red Blood Cells","W038112323158; W038112238855; W038112187650",".","3 units","Blood products, which were collected from a donor who traveled to malarial endemic areas, were distributed. ",1/22/2013,"01/22/2013",6/5/2013,"06/05/2013"
"Devices",64631,"Ongoing","Medtronic Xomed, Inc.","Jacksonville","FL","US","Voluntary: Firm Initiated","Letter","Worldwide distribution: AL, AR, AZ, CA, CO, FL, GA, HI, IL, IN, KS, KY, MA, MD, MI, MN, MT, NC, NH, NJ, NY, OH, PA, RI, SC, TX, UT, VA, and WA; and countries of : Australia, Canada, Germany, Italy, Norway, Poland and United Kingdom.","Z-1420-2013","Class I","REF 8229705 x1 NIM TriVantage EMG Endotracheal Tube 5.0 mm I.D. x 6.5 mm O.D. Medtronic Xomed, Inc., 6743 Southpoint Drive North, Jacksonville, FL 32216-0980 USA STERILE Rx Only The electrodes are designed to make contact with the patient's vocal cords to facilitate electromyographic (EMG) monitoring of the laryngeal musculature during surgery when connected to a multi-channel EMG neuromonitoring device.","Product Catalog Numbers: REF 8229705, 8229706, 8229707, 8229708, 8229709, 8229735, 8229736, 8229737, 8229738, 8229739. Lot Numbers: 205830052 to 206486732. 0206516104, 0206516105, 0206516106, 0206516108, 0206520224, 0206520225, 0206520226, 0206520227, 0206520228, 0206520358, 0206542163, 0206545356, 0206545502.",".","2,591 units","In March 2013, Medtronic issued a recall of the NIM TriVantage EMG Endotracheal Tube due to cuff leakage in the intraoperative cuff deflation which then requires re-inflation or replacement of the deflated tube in order to ensure the continued ventilation of the patient.",3/4/2013,"03/04/2013",6/12/2013,"06/12/2013"
"Biologics",64632,"Ongoing","BD Biosciences, Systems & Reagents","San Jose","CA","US","Voluntary: Firm Initiated","Letter","CA, GA, NC, NY, PA, OR, TX, OK, MO, VA, MI, NJ, CT, UT and to Australia, Canada, Belgium, China, India, South Korea, Taiwan.","B-1367-13","Class III","BD HLA-B27 Kit;510(k) BK050073; Manufactured by BD Biosciences 2350 Qume Drive San Jose, CA 95131","Model number 340183;Lot numbers 3029914 and 3035581",".","2","Certain lots of HLA-B27 FITC/CD3 PE reagent contained in the HLA-B27 kit, contaminated with CD4 PE, were distributed. ",3/14/2013,"03/14/2013",4/24/2013,"04/24/2013"
"Devices",64633,"Ongoing","Keystone Dental Inc","Burlington","MA","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Worldwide Distribution-USA including DC and the states of CA, FL, IN, MA, MN, NJ, NY, NH, PA, WI, and NY, and the countries of Republic of China, Germany, and France.","Z-0973-2013","Class II","PrimaConnex Tapered Implant TC, SD Internal Connection 3.5 x 10mmCatalog Number: l5613K. Implants in support for fixed bridgework.","Lot Number: 12857",".","120 units","Mislabeled: Cover screw that was in the package was a WD cover screw and not a SD cover screw as labeled",3/11/2013,"03/11/2013",3/27/2013,"03/27/2013"
"Drugs",64634,"Ongoing","Carib Import & Export, Inc.","Miami","FL","US","Voluntary: Firm Initiated",,"Nationwide, Bahamas, and Turks & Caicos Islands","D-307-2013","Class II","Infants Gripe Mixture, Each 5 mL contains: Light Magnesium Carbonate BP, 200.0 mg; Sodium Bicarbonate BP, 100.0 mg; Sucrose, 487.5 mg; Alcohol, 0.362 mL; Fennel Oil BP, 0.004 mL; Dill Oil BP, 0.005 mL), 120 mL bottle, Manufactured by: P.A. Benjamin Manufacturing Co. Ltd., 97 East Street, Kingston, JAMAICA; UPC 0 83276 34324 8.","Lot JZ28, Exp 03/13",,"480 bottles","CGMP Deviations: this product is being recalled because an FDA inspection revealed that it was not manufactured under current good manufacturing practices.",2/4/2013,"02/04/2013",5/8/2013,"05/08/2013"
"Drugs",64635,"Terminated","Petnet Solution Inc","Irvine","CA","US","Voluntary: Firm Initiated","Telephone","Within the state of CA.","D-579-2013","Class II","Fludeoxyglucose F 18 Injection USP, 20-200 mCi/mL, Diagnostic - For Intravenous Use Only, Manufactured by PETNET Solutions, Inc., Knoxville, TN","Batch # BN-3350 Rx #s: [38126044] [38126058] [38126059] [38126021] [38126022] [38126023] [38125981] [38125991] [38125992] [38126016] [38126017] [38126004] [38126005] [38126006] [38126007] [38126057] [38125999] [38126036] [38126037] [38126038] [38125998] [38126033]",".","28 doses","cGMP Deviation",2/22/2013,"02/22/2013",6/12/2013,"06/12/2013"
"Food",64636,"Ongoing","Nishimoto Trading Co Ltd","Santa Fe Springs","CA","US","Voluntary: Firm Initiated","Letter","CA, HI, IL","F-1269-2013","Class I","Kameda Brand Rice Cracker Kotsubukko, 12/4.37 oz, Item #63018.","UPC Code 0-74410-63018-8. Expiration Dates: 2013/03/15 2013/03/27 2013/03/28 2013/03/31 2013/04/05 2013/04/17 2013/04/19 2013/04/21 2013/04/23 2013/04/24 2013/04/28 2013/05/26 2013/05/27 2013/06/03 2013/06/13 2013/06/22 2013/06/23 2013/07/03 2013/07/17 2013/07/18 2013/07/21 ",,"2,072 units","Nishimoto Trading Co. is recalling Kameda Brand Rice Cracker Kotsubukko because it contains undeclared milk.",3/8/2013,"03/08/2013",4/3/2013,"04/03/2013"
"Food",64637,"Ongoing","Beehive Botanicals, Inc.","Hayward","WI","US","Voluntary: Firm Initiated","Telephone","CA, NY, CANADA","F-1287-2013","Class II","Propolis Chunks-Coarse Ground, Standardized Bee Propolis Lot #: SDM-10081155/60, EXP: 10/14, 1# BAG. ","SDM-1008115/60",".","17 lbs","Beehive Botanical, Inc is recalling several lots of Propolis 55-60% due to positive identification of Fluvalinate.",3/1/2013,"03/01/2013",4/10/2013,"04/10/2013"
"Food",64637,"Ongoing","Beehive Botanicals, Inc.","Hayward","WI","US","Voluntary: Firm Initiated","Telephone","CA, NY, CANADA","F-1286-2013","Class II","Propolis Powder -100% Standardized Bee-Propolis Lot #: 021113-55/60, EXP: 10/14 11# Bag & Lot#: 10081155/60-120612-100, EXP: 12/15, 1# BAG. ","10081155/60-120612-100; 021113-55/60",".","4,615 LBS","Beehive Botanical, Inc is recalling several lots of Propolis 55-60% due to positive identification of Fluvalinate.",3/1/2013,"03/01/2013",4/10/2013,"04/10/2013"
"Devices",64638,"Ongoing","Nova Biomedical Corporation","Waltham","MA","US","Voluntary: Firm Initiated","Telephone","Worldwide distribution: USA (nationwide) including states of: CA, IL, KY,NY, WV and countries of: United Kingdom and Italy.","Z-1153-2013","Class II","Nova StatStrip Xpress Glu-Test Strips (Glucose test strips) Catalog # 42214","Lot 0312349249, Expires 12/31/2014 and Lot 0312361309, Expires 06/30/2015 Expanded recall: Lot 0313021309, Expires 07/31/2015",".","7433 cases ","Glucose test strips reports no result message when tested ",2/25/2013,"02/25/2013",5/1/2013,"05/01/2013"
"Devices",64638,"Ongoing","Nova Biomedical Corporation","Waltham","MA","US","Voluntary: Firm Initiated","Telephone","Worldwide distribution: USA (nationwide) including states of: CA, IL, KY,NY, WV and countries of: United Kingdom and Italy.","Z-1154-2013","Class II","Nova StatStrip Xpress Glu-Test Strips (Glucose test strips) Catalog # 51493 (UK Only)","Lot 0312361309, Expires 6/30/2015 Expanded recall: Lot 0313021309, Expires 07/31/2015",".","2200 cases ","Glucose test strips reports no result message when tested ",2/25/2013,"02/25/2013",5/1/2013,"05/01/2013"
"Biologics",64639,"Terminated","Blood Bank Of San Bernardino And Riverside Counties","San Bernardino","CA","US","Voluntary: Firm Initiated","Letter","California; Georgia","B-1437-13","Class II","Red Blood Cells Leukocytes Reduced","W125612431026",".","1 unit","Blood products, collected from a donor with a history of Hepatitis A, were distributed.",2/4/2013,"02/04/2013",6/5/2013,"06/05/2013"
"Biologics",64639,"Terminated","Blood Bank Of San Bernardino And Riverside Counties","San Bernardino","CA","US","Voluntary: Firm Initiated","Letter","California; Georgia","B-1438-13","Class II","Blood and Blood Products for Reprocessing","W125612431026",".","1 unit","Blood products, collected from a donor with a history of Hepatitis A, were distributed.",2/4/2013,"02/04/2013",6/5/2013,"06/05/2013"
"Drugs",64640,"Ongoing","Med Prep Consulting, Inc.","Tinton Falls","NJ","US","Voluntary: Firm Initiated","Telephone","Press States Nationwide. Distribution List indicates the following: DE, FL, IL, IN, ME, MI, NJ, PA, TX, and VA","D-811-2013","Class II","All Compounded Products, packaged in plastic infusion bags, devices, syringes and glass vials, Med Prep Consulting Inc., Tinton Falls, NJ 07712","All lots",,,"Lack of Assurance of Sterility; potential for mold contamination",3/14/2013,"03/14/2013",7/31/2013,"07/31/2013"
"Drugs",64640,"Ongoing","Med Prep Consulting, Inc.","Tinton Falls","NJ","US","Voluntary: Firm Initiated","Telephone","Press States Nationwide. Distribution List indicates the following: DE, FL, IL, IN, ME, MI, NJ, PA, TX, and VA","D-810-2013","Class I","Magnesium Sulfate 2 grams in Dextrose 5% for Injection, in 50 mL Plastic Infusion Bags, Med Prep Consulting Inc., Tinton Falls, NJ 07712","All lots",,"403883 bags","Non-Sterility; mold contamination",3/14/2013,"03/14/2013",7/31/2013,"07/31/2013"
"Devices",64641,"Ongoing","Maquet Cardiovascular, LLC","Wayne","NJ","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution - USA Nationwide and the following countries: Australia, Austria, Belarus, Belgium, Canada, Columbia, Croatia, Czech Republic, Denmark, Egypt, Finland, France, Germany, Greece, Hong Kong, Iceland, Iran, Ireland, Italy, Jordan, Kazakhstan, Korea, Kuwait, Luxembourg, The Netherlands, Norway, Oman, Poland, Portugal, Russia, Saudi Arabia, Singapore, Slovakia, Slovenia, South Africa, Spain, Sweden, Switzerland, Thailand, Turkey, United Arab Emirates and the United Kingdom.","Z-1149-2013","Class II","MAQUET CARDIOHELP Support System: CARDIOHELP-I Software (up to version 3.3.0.0) Product Usage: The Cardiohelp System is a blood oxygenation and carbon dioxide removal system used to pump blood through the extracorporeal bypass circuit for circulatory and/or pulmonary support during procedures requiring cardiopulmonary bypass (for periods up to six hours). It is also intended to provide circulatory and/or pulmonary support during procedures not requiring cardiopulmonary bypass (for periods up to six hours). ","Catalog Number: 70104.8012 Cardiohelp-i. Multiple serial numbers.",".","154 units affected","It has come to the attention of MAQUET that there have been episodes of brief unexpected shutdown, followed by an automatic device restart of the human machine interface (touch screen) of the CARDIOHELP device. The human machine interface (HMI) is the central display of the CARDIOHELP device, where measured values, settings and alarms are displayed and adjusted/confirmed, with the exception of blood flow which is set by a separate rotary knob located at the front of the device. ",3/7/2013,"03/07/2013",4/24/2013,"04/24/2013"
"Drugs",64643,"Ongoing","Teva Pharmaceuticals USA, Inc.","Sellersville","PA","US","Voluntary: Firm Initiated","Letter","Nationwide and Puerto Rico","D-689-2013","Class III","Errin (norethindrone tablets, USP), 0.35 mg, 6 blister cards per carton, 28 tablets each, 28 day regimen, Rx Only, Teva Pharmaceuticals USA, Sellersville, PA 18960, NDC 0555-0344-58","Lot #s: 33801773A, Exp 7/14; 33801774A, Exp 8/14; 33801775A, 33801776A, Exp 9/14; 33802427A, 33802428A, 33802429A, 33802430A, Exp 12/14; 33802925A, 33802926A, Exp 3/15; 33803383A, 33803384A, 33803385A, 33803387A, 33803685A, Exp 6/15.",".","154,536 cartons","Failed Impurity/Degradation Specification; an impurity identified as N-Butyl-Benzene Sulfonamide (NBBS) was detected during impurity testing",3/15/2013,"03/15/2013",7/17/2013,"07/17/2013"
"Drugs",64643,"Ongoing","Teva Pharmaceuticals USA, Inc.","Sellersville","PA","US","Voluntary: Firm Initiated","Letter","Nationwide and Puerto Rico","D-690-2013","Class III","Camila (norethindrone tablets, USP), 0.35 mg, 6 blister cards per carton, 28 tablets each, 28 day regimen, Rx Only, Teva Pharmaceuticals USA, Sellersville, PA 18960, NDC 0555-0715-58","Lot #s: 33802107A, 33802108A, Exp 9/13; 33802109A, 33802110A, 33802111A, 33802112A, Exp10/13; 33802560A, Exp 1/14.",".","59,240 Cartons","Failed Impurity/Degradation Specification; an impurity identified as N-Butyl-Benzene Sulfonamide (NBBS) was detected during impurity testing",3/15/2013,"03/15/2013",7/17/2013,"07/17/2013"
"Drugs",64644,"Ongoing","Teva Pharmaceuticals USA, Inc.","Sellersville","PA","US","Voluntary: Firm Initiated","Letter","Nationwide distribution. No foreign or government accounts.","D-684-2013","Class III","Balziva(TM) (norethindrone and ethinyl estradiol tablets, USP) 0.15 mg/0.03 mg, 28 day regimen, Rx only, Barr Laboratories, Inc., Pomona, NY --- NDC 0555-9034-58","NDC 0555-9034-58, Lot numbers 33802100A, exp 3/2013; 33802266A, exp 3/2013; and 33802832A, exp 8/2013.",".","36,708 blister packs","Failed Impurity/Degradation Specification; an impurity identified as N-Butyl-Benzene Sulfonamide (NBBS) was detected during impurity testing ",3/15/2013,"03/15/2013",7/17/2013,"07/17/2013"
"Drugs",64644,"Ongoing","Teva Pharmaceuticals USA, Inc.","Sellersville","PA","US","Voluntary: Firm Initiated","Letter","Nationwide distribution. No foreign or government accounts.","D-681-2013","Class III","Lessina(R) (Levonorgestrel and ethinyl estradiol tablets, USP) 0.1 mg/0.02 mg, 28 day regimen, Rx only, Barr Laboratories Inc., Pomona, NY --- NDC 0555-9014-67","NDC 0555-9014-67, Lot numbers 33802921A, exp 8/2013; 33803173A, exp 10/2013; 33803695A, exp 2/2014; and 33803942A, exp 3/2014.",".","148,785 blister packs","Failed Impurity/Degradation Specification; an impurity identified as N-Butyl-Benzene Sulfonamide (NBBS) was detected during impurity testing ",3/15/2013,"03/15/2013",7/17/2013,"07/17/2013"
"Drugs",64644,"Ongoing","Teva Pharmaceuticals USA, Inc.","Sellersville","PA","US","Voluntary: Firm Initiated","Letter","Nationwide distribution. No foreign or government accounts.","D-683-2013","Class III","Jolessa(R) (levonorgestrel/ethinyl estradiol tablets, USP) 0.15 mg/0.03 mg, 91 day regimen, Rx only, Manufactured by Barr Laboratories, Inc., Pomona, NY, manufactured for TEVA Pharmaceuticals USA, Sellersville, PA ---NDC 0555-9123-66","NDC 0555-9123-66, Lot numbers 33802986A, exp 9/2013; 33802991A, exp 7/2013; and 33803270A, exp 10/2013.",".","54,412 blister packs","Failed Impurity/Degradation Specification; an impurity identified as N-Butyl-Benzene Sulfonamide (NBBS) was detected during impurity testing ",3/15/2013,"03/15/2013",7/17/2013,"07/17/2013"
"Drugs",64644,"Ongoing","Teva Pharmaceuticals USA, Inc.","Sellersville","PA","US","Voluntary: Firm Initiated","Letter","Nationwide distribution. No foreign or government accounts.","D-682-2013","Class III","Junel(TM) Fe 1.5/30 (norethindrone acetate and ethinyl estradiol tablets, USP and ferrous fumarate tablets), 28 day regimen, Rx only, Barr laboratories, Pomona, NY --- NDC 0555-9028-58","NDC 0555-9028-58, Lot numbers 33802123A, exp 4/2013; 33802202A, exp 5/2013; 33802203A, exp 5/2013; and 33802204A, exp 5/2013.",".","47,200 blister packs","Failed Impurity/Degradation Specification; an impurity identified as N-Butyl-Benzene Sulfonamide (NBBS) was detected during impurity testing ",3/15/2013,"03/15/2013",7/17/2013,"07/17/2013"
"Devices",64645,"Ongoing","Maquet Cardiovascular Us Sales, Llc","Wayne","NJ","US","Voluntary: Firm Initiated","Letter","Worldwide distribution: USA (nationwide) and countries of: ALGERIA, ANDORRA, ANTILLES (Netherlands), ARGENTINA, ARUBA, AUSTRALIA, AUSTRIA, AZERBADJAN, BANGLADESH, BELARUS, BELGIUM, BOLIVIA, BOTSWANA, BRAZIL, BRUNEI, BULGARIA, CANADA, CHILE, CHINA, COLOMBIA, CONGO, COSTA RICA, CROATIA, CUBA, CZECH REPUBLIC, DENMARK, DOMINICAN REPUBLIC, ECUADOR, EGYPT, EL SALVADOR, ESTONIA, YUGOSLAVIA (Former), FIJI, FINLAND, FRANCE, GEORGIA, GERMANY, GREECE, GUATEMALA, GUYANA, HONDURAS, HONG KONG, HUNGARY, ICELAND, INDIA, INDONESIA, IRAN, IRAQ, IRELAND, ISRAEL, ITALY, JAMAICA, JAPAN, KENYA, KUWAIT, KYRGYZSTAN, LATVIA, LIBYA, LITHUANIA, LUXEMBURG, MACAU, MACEDONIA, MALAYSIA, MALDIVES, MARTINIQUE (French), MEXICO, MOLDAVIA, MOROCCO, NEPAL, NETHERLANDS, NEW CALEDONIA (French), NEW ZEALAND, NICARAGUA, NIGERIA, NORWAY, OMAN, PAKISTAN, PALESTINE, PANAMA, PAPUA NEW GUINEA, PARAGUAY, PERU, PHILIPPINES, POLAND, POLYNESIA (French), PORTUGAL, QATAR, REUNION (French), ROMANIA, RUSSIA, SAUDI ARABIA, SERBIA, SEYCHELLES, SINGAPORE, SLOVAK REPUBLIC, SLOVENIA, SOUTH AFRICA, SOUTH KOREA, SPAIN, SRI LANKA, SUDAN, SURINAM, SWEDEN, SWITZERLAND, SYRIA, TADJIKISTAN, TAIWAN, TANZANIA, THAILAND, TRINIDAD AND TOBAGO, TUNISIA, TURKEY, UKRAINE, UNITED ARAB EMIRATES, UNITED KINGDOM, URUGUAY, VATICAN city state, VENEZUELA, VIETNAM and YEMEN.","Z-1177-2013","Class I","Maquet Getinge Group battery modules for use with Maquet SERVO-i ventilator systems (Part #6487180). Battery for use with the SERVO-i Ventilator System. The SERVO-i Ventilator System is intended for treating and monitoring patients ranging from neonates to adults with respiratory failure or insufficiency. The ventilator is equipped with at least 2, NiMH battery modules (Part No. 6487180) which automatically supply 12V DC Power in case of an AC power failure, ensuring that ventilator settings and stored data remain intact in the event of an AC power failure. The battery modules give the user a possibility to use the SERVO-i during intra-hospital transportation. ","SERVO-i Battery Module part number is 6487180. Notice pertains to Battery Modules manufactured between February 2010 and October 2012 with date codes between 1005 and 1243.",,"90,000 units (batteries)","When using the SERVO-i on battery power, in a very small number of cases, some battery modules distributed after January 31, 2010 have a shorter battery run time than expected. ",3/7/2013,"03/07/2013",5/8/2013,"05/08/2013"
"Devices",64646,"Ongoing","Synvasive Technology Inc","El Dorado Hills","CA","US","Voluntary: Firm Initiated","Letter","USA Distribution in the state of IN","Z-1127-2013","Class II","The Oxford Partial Knee; Oxford Knee Resection Procedure 3 Pack CEMENTED For use with Stryker System 5, System 4, System 2000 and EDH. Product Usage: For use with Stryker System 5, System 4, System 2000 and EDH. A set of three surgical saw blades is used to resect damaged cartilage and/or bone in an orthopedic reconstructive procedure such as a partial knee replacement. The set contains both oscillating blades for tissue resection along a small arc in a left/right or up/down direction, and reciprocating blades for resection back and forth in a single plane.","Biomet Product code: 506076, Lot 829182. Synvasive Part Number: 11-3629.",".","100 kits","Biomet part # 506076, lot 928182 was received from Synvasive Technology containing the incorrect blade.",3/14/2013,"03/14/2013",4/24/2013,"04/24/2013"
"Devices",64647,"Ongoing","Linvatec Corp. dba ConMed Linvatec","Largo","FL","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Worldwide Distribution-USA (nationwide) including the Virgin Islands and the states of CA, CT, FL, GA, IN, KY, KS, LA, MD, MI, MN, MO, MS, MT, NE, NC, NJ, NY, OH, OR, PA, SC, TN, TX, UT, VA, and WI, and the countries of Austria, Belgium, Canada, Denmark, Hong Kong and Zambia.","Z-1340-2013","Class II","Ref: VP1600 HD Still Capture System ConMed Linvatec . Captures, stores and transfers images generated by a medical endoscopic camera system during surgical procedures.","VP1600",".","267 units","The VP1600 HD Still Capture Image System is recalled due to an anomaly between the software code in the VP1600 console and the communications interface for various keyboard key strokes (Caps lock and Num Lock) which may lock up and requires the user to reboot to continue. ",3/18/2013,"03/18/2013",5/29/2013,"05/29/2013"
"Biologics",64648,"Ongoing","San Diego Blood Bank","San Diego","CA","US","Voluntary: Firm Initiated","Letter","Nationwide in US: LA, TX, TN, IL, MS, OH","B-1366-13","Class III","Plasma Frozen within 24 hours (FP24) after phlebotomy, 281 ml from CP20 Whole Blood, Store at -18 degrees Celsius or colder.","W044212478995 W044212486280 W044212491475 W044212490604 W044212489880 W044212489075 W044212482806 W044212489045 W044212492913 W044212486252 W044212482004 W044212489030 W044212492982 W044212492969 W044212485939 W044212485901 W044212492910 W044212492946 W044212490488 W044212484516 W044212486182 W044212481886 W044212486246 W044212489023 W044212492916 W044212489032 W044212492936 W044212478942 W044212478945 W044212490216 W044212490220 W044212486210 W044212481332 W044212489122 W044212481498 W044212481501 W044212491923 W044212486752 W044212485714 W044212490527 W044212490480 W044212490167 W044212490176 W044212489019 W044212489131 W044212482555 W044212482547 W044212490285 W044212490320 W044212490524 W044212490446 W044212475942 W044212490470 W044212485913 W044212489029 W044212489175 W044212489046 W044212486258 W044212478993 W044212478999 W044212476241 W044212493545 W044212493563 W044212493073 W044212493721 W044212496139 W044212493546 W044212493542 W044212476274 W044212496140 W044212492632 W044212493732 W044212493558 W044212489285 W044212493564 W044212491128 W044212491133 W044212492608 W044212492618 W044212491120 W044212476272 W044212492609 W044212492639 W044212491127 W044212496148 W044212493530 W044212493517 W044212493710 W044212476237 W044212493046 W044212484910 W044212484918 W044212493049 W044212484902 W044212493720 W044212496172 W044212496159 W044212484944 W044212496153 W044212492629 W044212481298 W044212482832 W044212476096 W044212478974 W044212482003 W044212492358 W044212489693 W044212492380 W044212492355 W044212486307 W044212486308 W044212486306 W044212479006 W044212493702 W044212484968 W044212484959 W044212493593 W044212493591 W044212492343 W044212492334 W044212496201 W044212481599 W044212489990 W044212486059 W044212486055 W044212486072 W044212490006 W044212496224 W044212491132 W044212492476 W044212485030 W044212485032 W044212493741 W044212495707 W044212501142 W044212490633 W044212488555 W044212479015 W044212501180 W044212501191 W044212485049 W044212501188 W044212485063 W044212489810 W044212489815 W044212495761 W",,"759 units","Unlicenseed blood products were distributed in interstate commerce.",1/22/2013,"01/22/2013",4/17/2013,"04/17/2013"
"Food",64649,"Ongoing","Mike-Sells Potato Chip Co","Dayton","OH","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Product was shipped to the following states: Illinois, Indiana, Kentucky and Ohio.","F-1307-2013","Class II","Mikesell's Honey Barbecue TOMATO AND SPICES WITH A HINT OF SWEET FLAVORED POTATO CHIPS Gluten Free 1 oz., 2 oz., 6 oz., 10 oz., 16 oz. MIKESELL'S SNACK FOOD CO. P.O. BOX 115 DAYTON, OH 45404.","All lots with with Sell By Dates on or before May 211 oz. UPC code: 0-71104-10171-9 2 oz. UPC code: 0-71104-40170-3 6 oz. UPC code: 0-71104-60152-3 10 oz. UPC code: 0-71104-50176-2 16 oz. UPC code: 0-71104-10154-5",,"385,011 packages","The firm received complaints of illness involving the product. Further investigation revealed that the package was mislabeled as ''Gluten Free''",3/8/2013,"03/08/2013",4/17/2013,"04/17/2013"
"Devices",64650,"Ongoing","QIAGEN Gaithersburg, Inc.","Gaithersburg","MD","US","Voluntary: Firm Initiated","E-Mail","USA Nationwide Distribution including the states of: CA, DC, FL, GA, MA, MD, MI, and IL.","Z-1321-2013","Class II","QIAGEN artus CMV RG PCR ASR (24) (Catalog number 4503223) Product Usage: The artus CMV RG PCR ASR is designed to detect and to quantify nucleic acid specific to human cytomegalovirus (CMV) using real-time PCR technology (PCR) in the Rotor-Gene 2000/3000 (RG). ","Catalog Number 4503223, Lot #142345647, Exp: 06/09/14",,"90 kits in total","CMV RG PCR kits may contain a mixture of incorrect vials among the correct vials.",1/30/2013,"01/30/2013",5/22/2013,"05/22/2013"
"Devices",64650,"Ongoing","QIAGEN Gaithersburg, Inc.","Gaithersburg","MD","US","Voluntary: Firm Initiated","E-Mail","USA Nationwide Distribution including the states of: CA, DC, FL, GA, MA, MD, MI, and IL.","Z-1320-2013","Class II","QIAGEN artus CMV RG PCR ASR (96) (Catalog number 4503225) Product Usage: Test is intended for use in the detection and quantitation of human cytomegalovirus (CMV) specific DNA, as part of an in house validated real-time PCR assay. One service package containing the handbook. ","Catalog Number 4503225, Lot #142345648, Exp: 06/09/14 & Lot #142357718 Exp: 06/09/14",,"90 kits in total","CMV RG PCR kits may contain a mixture of incorrect vials among the correct vials.",1/30/2013,"01/30/2013",5/22/2013,"05/22/2013"
"Drugs",64652,"Ongoing","Reckitt Benckiser Inc","Parsippany","NJ","US","Voluntary: Firm Initiated","Letter","Nationwide","D-310-2013","Class III","Cherry Cepacol Sore Throat Lozenges, Benzocaine 15 mg | Menthol 3.6 mg, a)16-count, NDC 63824-711-16 b) Institutional Size, 576-count, NDC 63824-711-98, OTC, Dist. by: Reckitt Benckiser, Parsippany, NJ 07054","16 count: AG156 Exp 11/13, AG257 Exp 12/13, AH388 02/14, AJ167 03/14, AL367 Exp 05/14, AL555 & AL568 Exp 06/14, AM141 Exp 07/14. 576 Count: AK505 Exp 04/14, AK570 Exp 05/14, AH368 & AH398 Exp 02/14, AJ000 Exp 03/14, AG596 Exp 12/13, ",,"27,718 cases 16 count and 7,551 cases 576 count","Subpotent Drug: Product did not conform to the 18-month stability test specification for active Free Benzocaine.",3/18/2013,"03/18/2013",5/8/2013,"05/08/2013"
"Devices",64653,"Ongoing","Carefusion Corporation","San Diego","CA","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution USA Nationwide and the countries of Australia and Canada.","Z-1112-2013","Class II","Alaris PC unit model 8015 with software version 9.12 Product Usage: The Alaris PC unit is the central programming, monitoring and power supply component for the Alaris System ","not available",".","4,090 total units","The recall was initiated because Carefusion has identified potential risk associated with bolus programming with the Alaris PC unit (model 8015) software version 9.12. Automating infusion pump parameter input from either the electronic medical record (EMR) or the Alaris Auto-ID module for a continuous infusion with a bolus dose option may result in a loss of information from the Guardrails Data set while programming a bolus dose.",3/6/2013,"03/06/2013",4/24/2013,"04/24/2013"
"Devices",64654,"Ongoing"," AGFA Corp.","Greenville","SC","US","Voluntary: Firm Initiated","Letter","Distribute in the state of FL and KY","Z-1069-2013","Class II","IMPAX CV 7.8 SU3 - OCR Service. The IMPAX CV Reporting component facilitates the quick , effective creation of digital structured reports for adult catheterization and echocardiography, pediatric echocardiography, congenital heart disease, nuclear cardiology and non-invasive vascular disease management.","Softwaer version: IMPAX CR 7.8 SU3 Optical Character Recognition (OCR) Service",,"2","Software design error in IMPAX CV 7.8 SU3",3/15/2013,"03/15/2013",4/17/2013,"04/17/2013"
"Devices",64655,"Ongoing","Stryker Howmedica Osteonics Corp.","Mahwah","NJ","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution - USA (nationwide) and internationally to Canada, Japan, Australia, China, New Zealand, France, Italy, Netherlands, Poland, Spain, Sweden, Switzerland and the United Kingdom.","Z-1061-2013","Class II","Stryker Orthopaedics Baseplate Impactor Extractor TRIATHLON Instruments. Howmedica Osteonics Corp. 325 Corporate Drive, Mahwah, NJ 07430 USA A subsidiary of Stryker Corporation. Made in USA. Stryker France ZAC Satolas Green Pusignan Av de Satolas Green 69881 MEYZIEU Cedex France The Baseplate Impactor Extractor is intended to securely attach to the tibial baseplate or baseplate trial for impaction and extraction during surgery.","Catalog Number 6541-4-805. Lot Numbers: RD4V204; RD5V234; RD5V235; RD5V235A; RD5V235Y; RD5V236; RD5V236A; RD5V237; RD6A009; RD6A010; RD6A011; RD6A011P; RD6A012; RD6A051; RD6A052; RD6A053; RD6A053M; RD6A053T; RD6A061; RD6A061A; RD6A062; RD6A062N; RD6A063; RD6A063T; RD6A065; RD6A065D; RD6A065T; RD6A066; RD6A066A; RD6C103; RD6C103L; RD6C104; RD6C104Y; RD6C105; RD6C105M; RD6C105T; RD6C106; RD6C106A; RD6C108; RD6C109; RD6C109L; RD6C126; RD6H178; RD6H184; RD6H187; RD6L222; RD6L223; RD6L223A; RD6L224; RD6L224A; RD6L226; RD6L227; RD6L227A; RD6L227N; RD6M148; RD6M158; RD6M159; RD6M161; RD6M163; RD6M163A; RD6M163L; RD6M164; RD6M164A; RD6M165; RD6N046; RD6N046L; RD6N047; RD6N047N; RD6N048; RD6N052; RD6N052T; RD6N053; RD6N054; RD6N072; RD6N072H; RD6N073; RD6N074; RD6N074J; RD6N158; RD6N159; RD6N160; RD6S054; RD6S055; RD6S055A; RD6S056; RD6S081; RD6S082; RD6S082Y; RD6S083; RD6S083Y; RD6S084; RD6S084A; RD6S085; RD6S085Y; RD6S142; RD6S142Y; RD6S143; RD6S143A; RD6S144; RD6S144Y.",,"871 units","Stryker received reports from the field indicating that the handle detached from the cam of the Baseplate Impactor/Extractor Assembly.",2/23/2013,"02/23/2013",4/17/2013,"04/17/2013"
"Devices",64656,"Ongoing"," AGFA Corp.","Greenville","SC","US","Voluntary: Firm Initiated","Letter","Nationwide Distribution including the states of AK, GA, IL, KY, MA, NY, NC, RI, SC, TX, and VA.","Z-1070-2013","Class II","IMPAX CV Reporting Cardiac Catheterization module and IMPAX CV Outbound Reporting. Facilitates digital reports for catheterization, echocardiography, and congenital heart disease.","Model # L9M21000. Software versions: IMPAX CV 7.8, 7.8 SU1, 7.8 SU2 and 7.8 SU3, IMPAX CV 7.8 SU2.5 with IMPAX CV Outbound Report Stylesheet 7.8_HL",,"26","Baseline pulmonary capillary wedge (PCW) pressure values from IMPAX CV Reporting Cardiac Catheterization module were not correctly transferring into the hospital's electronic health record (EHR) system.",3/15/2013,"03/15/2013",4/17/2013,"04/17/2013"
"Drugs",64657,"Ongoing","Apotex Corp.","Weston","FL","US","Voluntary: Firm Initiated","Letter","Nationwide","D-806-2013","Class I","Piperacillin and Tazobactam for Injection, USP, 40.5 grams per Pharmacy Bulk Package vial, Rx only, Mfg. by: Hospira Healthcare India Pvt. Ltd., Irungattukottai - 602 105, India; Mfg. for: Apotex Corp., Weston, FL 33326, NDC 60505-0773-0.","Lot #: 503B015, 503B016, Exp 04/13; 503B019, 503B020, 503B021, 503B022, Exp 07/13; 503B024, Exp 08/13; 503B025, 503B026, 503B027, Exp 09/13; 503C005, 503C006, Exp 12/13; 503C007, 503C008, Exp 01/14; 503C018, Exp 04/14 ",".","37,303 vials","Crystallization: Potential to exhibit precipitation/crystallization in IV bag or IV line upon reconstitution.",3/18/2013,"03/18/2013",7/24/2013,"07/24/2013"
"Biologics",64658,"Terminated","Community Blood Center of Carolinas","Charlotte","NC","US","Voluntary: Firm Initiated","Telephone","North Carolina","B-1439-13","Class II","Platelets Pheresis Leukocytes Reduced Irradiated","W227013005262; ",".","1 unit","Blood products, which did not meet the acceptable product specifications, were distributed.",2/8/2013,"02/08/2013",6/5/2013,"06/05/2013"
"Biologics",64658,"Terminated","Community Blood Center of Carolinas","Charlotte","NC","US","Voluntary: Firm Initiated","Telephone","North Carolina","B-1440-13","Class II","Platelets Pheresis Leukocytes Reduced","W227013005262; W227013005262; ",".","2 units","Blood products, which did not meet the acceptable product specifications, were distributed.",2/8/2013,"02/08/2013",6/5/2013,"06/05/2013"
"Biologics",64659,"Terminated","Community Blood Center of Carolinas","Charlotte","NC","US","Voluntary: Firm Initiated","Telephone","North Carolina","B-1511-13","Class II","Platelets Pheresis Leukocytes Reduced Irradiated","W227013005263",,"1 unit","Blood products, which did not meet the acceptable product specifications, were distributed.",2/8/2013,"02/08/2013",6/26/2013,"06/26/2013"
"Biologics",64659,"Terminated","Community Blood Center of Carolinas","Charlotte","NC","US","Voluntary: Firm Initiated","Telephone","North Carolina","B-1512-13","Class II","Platelets Pheresis Leukocytes Reduced","W227013005263; W227013005263",,"2 units","Blood products, which did not meet the acceptable product specifications, were distributed.",2/8/2013,"02/08/2013",6/26/2013,"06/26/2013"
"Biologics",64660,"Terminated","CryoLife, Inc.","Kennesaw","GA","US","Voluntary: Firm Initiated","Letter","Germany, Federal Republic of","B-1365-13","Class III","Heart Valve","10045270",,"1","Human tissue allograft, recovered from a donor whose donor eligibility determination did not confirm the donor was free from risk factors for, and clinical evidence of infection due to relevant communicable disease agents and diseeases, was distributed. ",3/18/2013,"03/18/2013",4/17/2013,"04/17/2013"
"Drugs",64661,"Ongoing","Clinical Specialties Compounding Pharmacy","Augusta","GA","US","Voluntary: Firm Initiated","Telephone","FL, GA and SC.","D-654-2013","Class II","Methylcobalamin 1250 mcg/ml, Clinical Specialties Compounding Pharmacy, 318 Baston Road, Augusta, GA 30907 ","Lot number CABDCGAC:49, Exp date: 3/28/2013.",".","36ml","Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes",3/20/2013,"03/20/2013",7/10/2013,"07/10/2013"
"Drugs",64661,"Ongoing","Clinical Specialties Compounding Pharmacy","Augusta","GA","US","Voluntary: Firm Initiated","Telephone","FL, GA and SC.","D-664-2013","Class II","Test Cyp 10 mg/ml, Clinical Specialties Compounding Pharmacy, 318 Baston Road, Augusta, GA 30907 ","Lot number CABCAFBC:17, Exp date: 6/3/2013.",".","7ml","Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes",3/20/2013,"03/20/2013",7/10/2013,"07/10/2013"
"Drugs",64661,"Ongoing","Clinical Specialties Compounding Pharmacy","Augusta","GA","US","Voluntary: Firm Initiated","Telephone","FL, GA and SC.","D-653-2013","Class II","Methionine/Choline/Inositol/ B-12, Clinical Specialties Compounding Pharmacy, 318 Baston Road, Augusta, GA 30907 ","Lot number CABDAHAB:35, Exp date: 4/7/2013 and Lot number CABDBIAC:77, Exp date: 5/19/2013.",".","255ml total","Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes",3/20/2013,"03/20/2013",7/10/2013,"07/10/2013"
"Drugs",64661,"Ongoing","Clinical Specialties Compounding Pharmacy","Augusta","GA","US","Voluntary: Firm Initiated","Telephone","FL, GA and SC.","D-673-2013","Class II","Test cyp 50 mg/ml, Clinical Specialties Compounding Pharmacy, 318 Baston Road, Augusta, GA 30907 ","Lot number CABCCHBB:81, Exp date: 5/26/2013.",".","12ml","Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes",3/20/2013,"03/20/2013",7/10/2013,"07/10/2013"
"Drugs",64661,"Ongoing","Clinical Specialties Compounding Pharmacy","Augusta","GA","US","Voluntary: Firm Initiated","Telephone","FL, GA and SC.","D-677-2013","Class II","Test Cyp 50 mg-estradiol blend 22 mg, Clinical Specialties Compounding Pharmacy, 318 Baston Road, Augusta, GA 30907 ","Lot number CABCAIBA:36, Exp date: 4/6/2013; Lot number CABDDAAB:10, Exp date: 7/29/2013 and Lot number CABDAIAD:01 Exp date: 9/4/2013.",".","13ml total ","Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes",3/20/2013,"03/20/2013",7/10/2013,"07/10/2013"
"Drugs",64661,"Ongoing","Clinical Specialties Compounding Pharmacy","Augusta","GA","US","Voluntary: Firm Initiated","Telephone","FL, GA and SC.","D-658-2013","Class II","Ophthalmic dilation gel, Clinical Specialties Compounding Pharmacy, 318 Baston Road, Augusta, GA 30907","Lot number CABDBDAC:11, Exp date: 8/12/2013; Lot number CABCCHAJ:28, Exp date: 3/26/2013; Lot number CABCBBBA:57, Exp date: 4/9/2013; Lot number CABCCGBA:11, Exp date: 4/24/2013; Lot number CABCACBB:26, Exp date: 5/1/2013; Lot number CABCBGBB:54, Exp date: 5/15/2013; Lot number CABCCJBB:38, Exp date: 5/28/2013; Lot number CABCBDBC:40, Exp date: 6/11/2013; Lot number CABCCIBC:73, Exp date: 6/26/2013; Lot number CABDBBAB:32, Exp date: 7/10/2013; Lot number CABDCEAB:92, Exp date: 7/23/2013; Lot number CABDAHAC:76, Exp date: 8/6/2013; Lot number CABDCBAC:11, Exp date: 8/20/2013 and Lot number CABDAHAD:85, Exp date: 9/3/2013.",".","378ml total","Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes",3/20/2013,"03/20/2013",7/10/2013,"07/10/2013"
"Drugs",64661,"Ongoing","Clinical Specialties Compounding Pharmacy","Augusta","GA","US","Voluntary: Firm Initiated","Telephone","FL, GA and SC.","D-651-2013","Class II","Medroxyprogesterone 150 mg/ml,Clinical Specialties Compounding Pharmacy, 318 Baston Road, Augusta, GA 30907 ","Lot number CABDDBAB:21, Exp date: 7/30/2013; Lot number CABCBBBA:65, Exp date: 4/9/2013; Lot number CABCBBBA:77, Exp date: 4/9/2013; Lot number CABCBBBA:20 , Exp date: 4/9/2013; Lot number CABCCFBA:42, Exp date: 4/23/2013; Lot number CABCCFBA:59, Exp date: 4/23/2013; Lot number CABCCFBA:76, Exp date: 4/23/2013; Lot number CABCCFBA:85, Exp date: 4/23/2013; Lot number CABCCHBB:28, Exp date: 5/23/2013; Lot number CABCCHBB:46, Exp date: 5/23/2013; Lot number CABCCHBB:87, Exp date: 5/26/2013; Lot number CABCCHBB:30, Exp date: 5/26/2013; Lot number CABCBJBC:92, Exp date: 6/17/2013; Lot number CABCBJBC:93, Exp date: 6/17/2013; Lot number CABCBJBC:31, Exp date: 6/17/2013; Lot number CABDAIAC:21, Exp date: 8/7/2013; Lot number CABDDBAB:05, Exp date: 7/30/2013; Lot number CABDDBAB:03, Exp date: 7/30/2013; Lot numberCABDDBAB:43, Exp date: 7/30/2013; Lot number CABDAIAC:45, Exp date: 8/7/2013 and Lot number CABDAIAC:13, Exp date: 8/7/2013. ",".","220ml total","Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes",3/20/2013,"03/20/2013",7/10/2013,"07/10/2013"
"Drugs",64661,"Ongoing","Clinical Specialties Compounding Pharmacy","Augusta","GA","US","Voluntary: Firm Initiated","Telephone","FL, GA and SC.","D-671-2013","Class II","Test Cyp 25 mg-e(2) blend 12 mg/ml, Clinical Specialties Compounding Pharmacy, 318 Baston Road, Augusta, GA 30907 ","Lot number CABCCHBB:03, Exp date: 5/26/2013.","."," 8ml","Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes",3/20/2013,"03/20/2013",7/10/2013,"07/10/2013"
"Drugs",64661,"Ongoing","Clinical Specialties Compounding Pharmacy","Augusta","GA","US","Voluntary: Firm Initiated","Telephone","FL, GA and SC.","D-678-2013","Class II","Test cyp 75 mg-estradiol cyp 5 mg/ml, Clinical Specialties Compounding Pharmacy, 318 Baston Road, Augusta, GA 30907 ","Lot number CABCAIBB:44, Exp date: 5/7/2013.",".","11ml","Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes",3/20/2013,"03/20/2013",7/10/2013,"07/10/2013"
"Drugs",64661,"Ongoing","Clinical Specialties Compounding Pharmacy","Augusta","GA","US","Voluntary: Firm Initiated","Telephone","FL, GA and SC.","D-675-2013","Class II","Test Cyp 50 mg-estradiol cyp 2 mg/ml, Clinical Specialties Compounding Pharmacy, 318 Baston Road, Augusta, GA 30907 ","Lot number CABCACBA:23, Exp date: 3/31/2013 and Lot number CABDAIAD:13, Exp date: 9/4/2013.",".","13ml","Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes",3/20/2013,"03/20/2013",7/10/2013,"07/10/2013"
"Drugs",64661,"Ongoing","Clinical Specialties Compounding Pharmacy","Augusta","GA","US","Voluntary: Firm Initiated","Telephone","FL, GA and SC.","D-679-2013","Class II","Tetracaine(buffered) 0.25% solution, Clinical Specialties Compounding Pharmacy, 318 Baston Road, Augusta, GA 30907 ","Lot number CABDCCAB:46, Exp date: 4/22/2013; Lot number CABDAGAC:58, Exp date: 5/7/2013 and Lot number CABDAGAD:07 Exp date: 6/4/2013.",".","474ml total","Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes",3/20/2013,"03/20/2013",7/10/2013,"07/10/2013"
"Drugs",64661,"Ongoing","Clinical Specialties Compounding Pharmacy","Augusta","GA","US","Voluntary: Firm Initiated","Telephone","FL, GA and SC.","D-669-2013","Class II","Test Cyp 250 mg-lidocaine 5 mg/ml, Clinical Specialties Compounding Pharmacy, 318 Baston Road, Augusta, GA 30907 ","Lot number CABCCABB:74, Exp date: 5/19/2013 and Lot number CABCCABB:31 Exp date: 7/29/2013. ",".","10ml total","Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes",3/20/2013,"03/20/2013",7/10/2013,"07/10/2013"
"Drugs",64661,"Ongoing","Clinical Specialties Compounding Pharmacy","Augusta","GA","US","Voluntary: Firm Initiated","Telephone","FL, GA and SC.","D-649-2013","Class II","Laser ophthalmic drops, 12 mL bottle, Clinical Specialties Compounding Pharmacy, 318 Baston Road, Augusta, GA 30907 ","Lot number CABCCIBC:20, Exp date: 3/28/2013 and Lot number CABDAEAC:90, Exp date: 3/5/2013.",".",,"Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes",3/20/2013,"03/20/2013",7/10/2013,"07/10/2013"
"Drugs",64661,"Ongoing","Clinical Specialties Compounding Pharmacy","Augusta","GA","US","Voluntary: Firm Initiated","Telephone","FL, GA and SC.","D-643-2013","Class II","HCG 1000 units/ml, 30 mL syringe, Clinical Specialties Compounding Pharmacy, 318 Baston Road, Augusta, GA 30907 ","Lot number CABDAHAD:04 Exp date: 5/6/2013. ",".",,"Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes",3/20/2013,"03/20/2013",7/10/2013,"07/10/2013"
"Drugs",64661,"Ongoing","Clinical Specialties Compounding Pharmacy","Augusta","GA","US","Voluntary: Firm Initiated","Telephone","FL, GA and SC.","D-666-2013","Class II","Test Cyp 200 mg/ml, Clinical Specialties Compounding Pharmacy, 318 Baston Road, Augusta, GA 30907 ","Lot number CABCBJBA:26, Exp date: 4/17/2013; Lot number CABCBEBB:55, Exp date: 5/13/2013; Lot number CABCBEBB:75, Exp date: 5/13/2013; Lot number CABCCBBC:96, Exp date: 6/19/2013; Lot number CABCCHBC:80, Exp date: 6/25/2013; Lot number CABDAJAB:88, Exp date: 7/8/2013; Lot number CABDAEAB:41, Exp date: 7/3/2013; Lot number CABDBBAB:23, Exp date: 7/10/2013; Lot number CABDBHAB:14, Exp date: 7/16/2013; Lot number CABDCEAB:13, Exp date: 7/23/2013; Lot number CABDCFAB:33, Exp date: 7/24/2013 and Lot number CABDABAD:38, Exp date: 8/28/2013.",".","unknown","Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes",3/20/2013,"03/20/2013",7/10/2013,"07/10/2013"
"Drugs",64661,"Ongoing","Clinical Specialties Compounding Pharmacy","Augusta","GA","US","Voluntary: Firm Initiated","Telephone","FL, GA and SC.","D-647-2013","Class II","Injection vehicle, 120 ml, Clinical Specialties Compounding Pharmacy, 318 Baston Road, Augusta, GA 30907 ","Lot number CABCCHBB:59, Exp date: 5/26/2013.",".",,"Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes",3/20/2013,"03/20/2013",7/10/2013,"07/10/2013"
"Drugs",64661,"Ongoing","Clinical Specialties Compounding Pharmacy","Augusta","GA","US","Voluntary: Firm Initiated","Telephone","FL, GA and SC.","D-674-2013","Class II","Test Cyp 50 mg-estradiol cyp 2 mg/ml, Clinical Specialties Compounding Pharmacy, 318 Baston Road, Augusta, GA 30907 ","Lot number CABCACBB:31, Exp date: 10/28/2013 and Lot number CABDBGAB:74, Exp date: 1/11/2014.",".","65ml total","Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes",3/20/2013,"03/20/2013",7/10/2013,"07/10/2013"
"Drugs",64661,"Ongoing","Clinical Specialties Compounding Pharmacy","Augusta","GA","US","Voluntary: Firm Initiated","Telephone","FL, GA and SC.","D-650-2013","Class II","Latanoprost 0.025% eye drop, Clinical Specialties Compounding Pharmacy, 318 Baston Road, Augusta, GA 30907 ","Lot number CABDAFAD:09, Exp date: 5/4/2013",".","70ml total","Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes",3/20/2013,"03/20/2013",7/10/2013,"07/10/2013"
"Drugs",64661,"Ongoing","Clinical Specialties Compounding Pharmacy","Augusta","GA","US","Voluntary: Firm Initiated","Telephone","FL, GA and SC.","D-660-2013","Class II","Pap 300 mg-phent 10 mg-prost 100 mcg, Clinical Specialties Compounding Pharmacy, 318 Baston Road, Augusta, GA 30907 ","Lot number CABDBFAC:52, Exp date: 5/16/2013; Lot number CABDBBAB:40, Exp date: 4/11/2013; Lot number CABDCAAC:15, Exp date: 5/21/2013; Lot number CABDCCAC:75, Exp date: 5/23/2013 and Lot number CABDAFAD:77, Exp date: 6/3/2013.",".","96ml total","Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes",3/20/2013,"03/20/2013",7/10/2013,"07/10/2013"
"Drugs",64661,"Ongoing","Clinical Specialties Compounding Pharmacy","Augusta","GA","US","Voluntary: Firm Initiated","Telephone","FL, GA and SC.","D-633-2013","Class II","Acetylcysteine 20 % solution, 100 ml bottle, Clinical Specialties Compounding Pharmacy, 318 Baston Road, Augusta, GA 30907","Lot number CABCAJBA:76, Exp date: 10/4/2013",".",,"Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes.",3/20/2013,"03/20/2013",7/10/2013,"07/10/2013"
"Drugs",64661,"Ongoing","Clinical Specialties Compounding Pharmacy","Augusta","GA","US","Voluntary: Firm Initiated","Telephone","FL, GA and SC.","D-665-2013","Class II","Test Cyp 100 mg/ml, Clinical Specialties Compounding Pharmacy, 318 Baston Road, Augusta, GA 30907 ","Lot number CABCBFBA:15, Exp date: 4/13/2013; Lot number CABCACBA:58, Exp date: 3/31/2013; Lot number CABCAHBB:54, Exp date: 5/6/2013; Lot number CABCCHBB:63, Exp date: 5/26/2013; Lot number CABCAFBC:31, Exp date: 6/3/2013; Lot number CABCCHBS:23, Exp date: 6/25/2013; Lot number CABDBAAB:64, Exp date: 7/9/2013; Lot number CABDAIAB:59, Exp date: 7/7/2013; Lot number CABDAFAC:48, Exp date: 8/4/2013; Lot number CABDBJAC:27, Exp date: 8/18/2013 and Lot number CABDABAD:61, Exp date: 8/28/2013. ",".","219ml total ","Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes",3/20/2013,"03/20/2013",7/10/2013,"07/10/2013"
"Drugs",64661,"Ongoing","Clinical Specialties Compounding Pharmacy","Augusta","GA","US","Voluntary: Firm Initiated","Telephone","FL, GA and SC.","D-645-2013","Class II","HCG 500 units/ml, 10 mL syringe, Clinical Specialties Compounding Pharmacy, 318 Baston Road, Augusta, GA 30907 ","Lot number CABDBDAC:06, Exp date: 4/14/2013.",".",,"Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes",3/20/2013,"03/20/2013",7/10/2013,"07/10/2013"
"Drugs",64661,"Ongoing","Clinical Specialties Compounding Pharmacy","Augusta","GA","US","Voluntary: Firm Initiated","Telephone","FL, GA and SC.","D-655-2013","Class II","Methylcobalamin 12.5 mg/ml, Clinical Specialties Compounding Pharmacy, 318 Baston Road, Augusta, GA 30907 ","Lot number CABCBJBA:55, Exp date: 4/17/2013; Exp date: Lot number CABDCCAB:52, Exp date: 7/21/2013 and Lot number CABDCGAC:50, Exp date: 8/25/2013.",".","95ml total","Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes",3/20/2013,"03/20/2013",7/10/2013,"07/10/2013"
"Drugs",64661,"Ongoing","Clinical Specialties Compounding Pharmacy","Augusta","GA","US","Voluntary: Firm Initiated","Telephone","FL, GA and SC.","D-656-2013","Class II","Mitomycin 0.04% solution, Clinical Specialties Compounding Pharmacy, 318 Baston Road, Augusta, GA 30907 ","Lot number CABDAGAD:25, Exp date: 4/20/2013 and Lot number CABDAGAD:84, Exp date: 4/20/2013.","."," 50ml total","Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes",3/20/2013,"03/20/2013",7/10/2013,"07/10/2013"
"Drugs",64661,"Ongoing","Clinical Specialties Compounding Pharmacy","Augusta","GA","US","Voluntary: Firm Initiated","Telephone","FL, GA and SC.","D-644-2013","Class II","HCG 2000 units/ml, 30 mL syringe, Clinical Specialties Compounding Pharmacy, 318 Baston Road, Augusta, GA 30907 ","Lot number CABDAJAB:54, Exp date: 3/10/2013 and Lot number CABDABAC:38, Exp date: 5/31/2013.",".",,"Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes",3/20/2013,"03/20/2013",7/10/2013,"07/10/2013"
"Drugs",64661,"Ongoing","Clinical Specialties Compounding Pharmacy","Augusta","GA","US","Voluntary: Firm Initiated","Telephone","FL, GA and SC.","D-663-2013","Class II","Sodium Chloride (23.4%), Clinical Specialties Compounding Pharmacy, 318 Baston Road, Augusta, GA 30907 ","Lot number CABCCEAJ:09, Exp date: 3/23/2013; Lot number CABCBFBA:92, Exp date: 4/13/2013; Lot number CABDAGAC:58, Exp date: 8/5/2013 and Lot number CABDAEAD:01, Exp date: 8/31/2013. ",".","116ml total","Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes",3/20/2013,"03/20/2013",7/10/2013,"07/10/2013"
"Drugs",64661,"Ongoing","Clinical Specialties Compounding Pharmacy","Augusta","GA","US","Voluntary: Firm Initiated","Telephone","FL, GA and SC.","D-680-2013","Class II","Vancomycin 50 mg/ml, Clinical Specialties Compounding Pharmacy, 318 Baston Road, Augusta, GA 30907 ","Lot number CABDCCAC:54, Exp date: 3/24/2013.",".","20ml total","Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes",3/20/2013,"03/20/2013",7/10/2013,"07/10/2013"
"Drugs",64661,"Ongoing","Clinical Specialties Compounding Pharmacy","Augusta","GA","US","Voluntary: Firm Initiated","Telephone","FL, GA and SC.","D-661-2013","Class II","Phenylephrine-cyclopentolate, Clinical Specialties Compounding Pharmacy, 318 Baston Road, Augusta, GA 30907 ","Lot number CABDBIAB:14, Exp date: 7/17/2013.",".","60ml","Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes",3/20/2013,"03/20/2013",7/10/2013,"07/10/2013"
"Drugs",64661,"Ongoing","Clinical Specialties Compounding Pharmacy","Augusta","GA","US","Voluntary: Firm Initiated","Telephone","FL, GA and SC.","D-667-2013","Class II","Test cyp 25 mg-Estadiol valerate 15 mg/mL, Clinical Specialties Compounding Pharmacy, 318 Baston Road, Augusta, GA 30907 ","Lot number CABCBJBC:70, Exp date: 6/17/2013",".","7ml","Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes",3/20/2013,"03/20/2013",7/10/2013,"07/10/2013"
"Drugs",64661,"Ongoing","Clinical Specialties Compounding Pharmacy","Augusta","GA","US","Voluntary: Firm Initiated","Telephone","FL, GA and SC.","D-635-2013","Class II","Cataract drops, Clinical Specialties Compounding Pharmacy, 318 Baston Road, Augusta, GA 30907","Lot number CABDAEAC:07, Exp date: 5/5/2013; Lot number CABCCIBC:44, Exp date: 3/28/2013",".","80 ml total","Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes.",3/20/2013,"03/20/2013",7/10/2013,"07/10/2013"
"Drugs",64661,"Ongoing","Clinical Specialties Compounding Pharmacy","Augusta","GA","US","Voluntary: Firm Initiated","Telephone","FL, GA and SC.","D-632-2013","Class II","Acetylcysteine 10 % Solution, Clinical Specialties Compounding Pharmacy, 318 Baston Road, Augusta, GA 30907","Lot number CABCAFBA:73, Exp date: 9/30/2013",".","300ml","Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes",3/20/2013,"03/20/2013",7/10/2013,"07/10/2013"
"Drugs",64661,"Ongoing","Clinical Specialties Compounding Pharmacy","Augusta","GA","US","Voluntary: Firm Initiated","Telephone","FL, GA and SC.","D-652-2013","Class II","Medroxyprogesterone 50 mg/ml, Clinical Specialties Compounding Pharmacy, 318 Baston Road, Augusta, GA 30907 ","Lot number CABDABAC:01, Exp date: 5/2/2013.",".","2ml total","Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes",3/20/2013,"03/20/2013",7/10/2013,"07/10/2013"
"Drugs",64661,"Ongoing","Clinical Specialties Compounding Pharmacy","Augusta","GA","US","Voluntary: Firm Initiated","Telephone","FL, GA and SC.","D-676-2013","Class II","Test Cyp 50 mg-estradiol cyp 7 mg/ml, Clinical Specialties Compounding Pharmacy, 318 Baston Road, Augusta, GA 30907 ","Lot number CABCACBA:16, Exp date: 10/2/2013.",".","3ml","Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes",3/20/2013,"03/20/2013",7/10/2013,"07/10/2013"
"Drugs",64661,"Ongoing","Clinical Specialties Compounding Pharmacy","Augusta","GA","US","Voluntary: Firm Initiated","Telephone","FL, GA and SC.","D-659-2013","Class II","Ophthalmic dilation gel (MAR), Clinical Specialties Compounding Pharmacy, 318 Baston Road, Augusta, GA 30907 ","Lot number CABDBFAC:88, Exp date: 5/16/2013; and Lot number CABDCBAB:42, Exp date: 4/21/2013.",".","360ml total","Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes",3/20/2013,"03/20/2013",7/10/2013,"07/10/2013"
"Drugs",64661,"Ongoing","Clinical Specialties Compounding Pharmacy","Augusta","GA","US","Voluntary: Firm Initiated","Telephone","FL, GA and SC.","D-634-2013","Class II","Acetylcysteine 2 % Solution, Clinical Specialties Compounding Pharmacy, 318 Baston Road, Augusta, GA 30907","Lot number CABDBDAC:98, Exp date: 8/12/2013",".","10ml","Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes.",3/20/2013,"03/20/2013",7/10/2013,"07/10/2013"
"Drugs",64661,"Ongoing","Clinical Specialties Compounding Pharmacy","Augusta","GA","US","Voluntary: Firm Initiated","Telephone","FL, GA and SC.","D-638-2013","Class II","Diazepam 5 mg/ml, Clinical Specialties Compounding Pharmacy, 318 Baston Road, Augusta, GA 30907","Lot number CABDBGAB:84, Exp date: 4/16/2013 and Lot number CABDAIAC:45, Exp date: 5/9/2013.",".","222 ml total","Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes.",3/20/2013,"03/20/2013",7/10/2013,"07/10/2013"
"Drugs",64661,"Ongoing","Clinical Specialties Compounding Pharmacy","Augusta","GA","US","Voluntary: Firm Initiated","Telephone","FL, GA and SC.","D-672-2013","Class II","Test cyp 35 mg/ml, Clinical Specialties Compounding Pharmacy, 318 Baston Road, Augusta, GA 30907 ","Lot number CABDCAAC:13, Exp date: 8/19/2013.",".","12ml","Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes",3/20/2013,"03/20/2013",7/10/2013,"07/10/2013"
"Drugs",64661,"Ongoing","Clinical Specialties Compounding Pharmacy","Augusta","GA","US","Voluntary: Firm Initiated","Telephone","FL, GA and SC.","D-657-2013","Class II","Mitomycin (modified) 0.02% solution, Clinical Specialties Compounding Pharmacy, 318 Baston Road, Augusta, GA 30907 ","Lot number CABDAGAD:68 , Exp date: 4/20/2013 and Lot number CABDAGAD:60, Exp date: 4/20/2013.",".","6ml total","Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes",3/20/2013,"03/20/2013",7/10/2013,"07/10/2013"
"Drugs",64661,"Ongoing","Clinical Specialties Compounding Pharmacy","Augusta","GA","US","Voluntary: Firm Initiated","Telephone","FL, GA and SC.","D-639-2013","Class II","Estradiol Cypionate 5 mg/ml, Clinical Specialties Compounding Pharmacy, 318 Baston Road, Augusta, GA 30907","Lot number CABCACBA:20, Exp date: 3/31/2013; Lot number CABCABBB:22, Exp date: 4/30/2013; Lot number CABCBJBB:25, Exp date: 5/18/2013 and Lot number CABDAFAC:79, Exp date: 8/4/2013.",".","95 ml total","Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes.",3/20/2013,"03/20/2013",7/10/2013,"07/10/2013"
"Drugs",64661,"Ongoing","Clinical Specialties Compounding Pharmacy","Augusta","GA","US","Voluntary: Firm Initiated","Telephone","FL, GA and SC.","D-646-2013","Class II","Hydroxyprogesterone 250 mg/ml, Clinical Specialties Compounding Pharmacy, 318 Baston Road, Augusta, GA 30907 ","Lot number CABDAIAB:64, Exp date: 4/8/2013; Lot number CABDAEAB:21, Exp date: 4/4/2013; Lot number CABDBIAB:75, Exp date: 4/18/2013; Lot number CABDAEAC:00, Exp date: 5/5/2013 and Lot number CABDJAC:67, Exp date: 5/20/2013. ",".",,"Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes",3/20/2013,"03/20/2013",7/10/2013,"07/10/2013"
"Drugs",64661,"Ongoing","Clinical Specialties Compounding Pharmacy","Augusta","GA","US","Voluntary: Firm Initiated","Telephone","FL, GA and SC.","D-662-2013","Class II","Progesterone 50 mg/ml, Clinical Specialties Compounding Pharmacy, 318 Baston Road, Augusta, GA 30907 ","Lot number CABDBFAC:48, Exp date: 5/17/2014; and Lot number CABDCEAB:14, Exp date: 4/25/2014.",".","637ml total","Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes",3/20/2013,"03/20/2013",7/10/2013,"07/10/2013"
"Drugs",64661,"Ongoing","Clinical Specialties Compounding Pharmacy","Augusta","GA","US","Voluntary: Firm Initiated","Telephone","FL, GA and SC.","D-640-2013","Class II","Estradiol Valerate 20 mg/ml, Clinical Specialties Compounding Pharmacy, 318 Baston Road, Augusta, GA 30907","Lot number CABCADBA:96, Exp date: 4/1/2013 and Lot number CABCAIBA:31, Exp date: 4/6/2013.",".","17ml total","Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes",3/20/2013,"03/20/2013",7/10/2013,"07/10/2013"
"Drugs",64661,"Ongoing","Clinical Specialties Compounding Pharmacy","Augusta","GA","US","Voluntary: Firm Initiated","Telephone","FL, GA and SC.","D-637-2013","Class II","Cyclosporine 2% ophthalmic, Clinical Specialties Compounding Pharmacy, 318 Baston Road, Augusta, GA 30907","Lot number CABCCIBC:89, Exp date: 3/28/2013; Lot number CABDBEAB:07, Exp date: 4/14/2013; Lot number CABDCIAB:42, Exp date: 4/28/2013 and Lot number CABDCCAC:37, Exp date: 5/23/2013.",".","87 ml total ","Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes.",3/20/2013,"03/20/2013",7/10/2013,"07/10/2013"
"Drugs",64661,"Ongoing","Clinical Specialties Compounding Pharmacy","Augusta","GA","US","Voluntary: Firm Initiated","Telephone","FL, GA and SC.","D-648-2013","Class II","Itraconazole 1% eye ointment, Clinical Specialties Compounding Pharmacy, 318 Baston Road, Augusta, GA 30907 ","Lot number CABDCBAC:71, Exp date: 3/23/2013 and Lot number CABDCGAC:35, Exp date: 3/28/2013.",".","10ml total","Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes",3/20/2013,"03/20/2013",7/10/2013,"07/10/2013"
"Drugs",64661,"Ongoing","Clinical Specialties Compounding Pharmacy","Augusta","GA","US","Voluntary: Firm Initiated","Telephone","FL, GA and SC.","D-668-2013","Class II","Test cyp 25 mg-Estradiol cyp 5 mg/ml, Clinical Specialties Compounding Pharmacy, 318 Baston Road, Augusta, GA 30907 ","Lot number CABDBHAB:54, Exp date: 7/16/2013",".","4ml","Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes",3/20/2013,"03/20/2013",7/10/2013,"07/10/2013"
"Drugs",64661,"Ongoing","Clinical Specialties Compounding Pharmacy","Augusta","GA","US","Voluntary: Firm Initiated","Telephone","FL, GA and SC.","D-642-2013","Class II","Gentamicin buffered 36.4 mg/ml, Clinical Specialties Compounding Pharmacy, 318 Baston Road, Augusta, GA 30907","Lot number CABCAFBB:81, Exp date: 5/4/2013; Lot number CABCCEAJ:85 Exp date: 3/23/2013 and Lot number CABDCFAC:25 Exp date: 8/24/2013.",".","35ml total","Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes",3/20/2013,"03/20/2013",7/10/2013,"07/10/2013"
"Drugs",64661,"Ongoing","Clinical Specialties Compounding Pharmacy","Augusta","GA","US","Voluntary: Firm Initiated","Telephone","FL, GA and SC.","D-641-2013","Class II","Estradiol Valerate 30 mg/ml, Clinical Specialties Compounding Pharmacy, 318 Baston Road, Augusta, GA 30907 ","Lot number CABCBFBB:12, Exp date: 5/14/2013 and Lot number CABDAIAD:28, Exp date: 9/4/2013.",".","18ml total","Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes",3/20/2013,"03/20/2013",7/10/2013,"07/10/2013"
"Drugs",64661,"Ongoing","Clinical Specialties Compounding Pharmacy","Augusta","GA","US","Voluntary: Firm Initiated","Telephone","FL, GA and SC.","D-636-2013","Class II","Cyclosporine 1% ophthalmic drops, Clinical Specialties Compounding Pharmacy, 318 Baston Road, Augusta, GA 30907","Lot number CABCBEBB:35, Exp date: 5/13/2013; Lot number CABACAB:76 Exp date: 7/1/2013; Lot number CABDAIAB:78, Exp date: 4/8/2013; Lot number CABDAEAC:80, Exp date: 5/5/2013 and Lot number CABDCCAC:31, Exp date: 5/23/2013. ",".","55 ml","Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes.",3/20/2013,"03/20/2013",7/10/2013,"07/10/2013"
"Drugs",64661,"Ongoing","Clinical Specialties Compounding Pharmacy","Augusta","GA","US","Voluntary: Firm Initiated","Telephone","FL, GA and SC.","D-670-2013","Class II","Test cyp 25 mg-estradiol cyp 7 mg/ml, Clinical Specialties Compounding Pharmacy, 318 Baston Road, Augusta, GA 30907 ","Lot number CABCAFBC:67, Exp date: 6/3/2013.",".","12ml","Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes",3/20/2013,"03/20/2013",7/10/2013,"07/10/2013"
"Devices",64662,"Ongoing","Siemens Medical Solutions USA, Inc","Malvern","PA","US","Voluntary: Firm Initiated","Letter","Nationwide Distribution including AL, CA, CO, FL, IA, IL, IN, KY, MA, MD, ME, MI, MN, MO, NC, ND, NJ, NY, OH, PA, SC, TX, UT, VA, WA, and WI and to Puerto Rico.","Z-0997-2013","Class II","Artis Systems with Software Artis VC20x/VC21A/VD10x that have a DSA license installed. Angiographic x-ray system","Model numbers 10094135, 10094137, 10094139, 10094141 and 10280959.",,"81","The firm has become aware of a potential issue on Artis systems with the software Artis VC20x/VC21A/VD10x that have a DSA license installed. Under certain preconditions, executing roadmap OGP (organ program) in the DSA overlay mode may lead to imprecise registration of the DSA mask image with the roadmap image displayed on the live monitor. ",3/8/2013,"03/08/2013",4/3/2013,"04/03/2013"
"Veterinary",64663,"Ongoing","Procter & Gamble Co","Mason","OH","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Product was shipped to the following states: AL, AZ, CA, CO, CT, FL, GA, HI, IA, IL, IN, KS, KY, MA, MI, MN, MO, NC, NJ, NY, NC, OH, OR, PA, SC, TN, TX, UT, VA, WA & WI. Product was also shipped to Canada.","V-148-2013","Class III","Iams Shakeables Un-baa-lievable With Lamb for Dogs, 6 oz canister, DISTRIBUTED BY: THE IAMS COMPANY, SUBSIDIARY OF THE PROCTER & GAMBLE CINCINNATI, OHIO, 45202 ","UPC 0 19014 00024 1, Lot # 2338419715A 3102, Best By Date May 3, 2014",".","4009cs/6//6 oz canisters","The firm was notified via consumer complaints that the product contains mold.",3/11/2013,"03/11/2013",5/15/2013,"05/15/2013"
"Veterinary",64663,"Ongoing","Procter & Gamble Co","Mason","OH","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Product was shipped to the following states: AL, AZ, CA, CO, CT, FL, GA, HI, IA, IL, IN, KS, KY, MA, MI, MN, MO, NC, NJ, NY, NC, OH, OR, PA, SC, TN, TX, UT, VA, WA & WI. Product was also shipped to Canada.","V-147-2013","Class III","Iams Shakeables Gobble em Up With Turkey for Dogs, 6 oz canister, DISTRIBUTED BY: THE IAMS COMPANY, SUBSIDIARY OF THE PROCTER & GAMBLE CINCINNATI, OHIO, 45202 ","UPC 0 19014 61043 3, Lot # 2325419715A 3103, Best By Date April 20, 2014; Lot # 2331419715A 3103, Best By Date April 26, 2014; Lot # 2332419715A 3103, Best By Date April 26, 2014; Lot # 2341419715A 3103, Best By Date May 6, 2014; Lot # 2342419715A 3103, Best By Date May 7, 2014; Lot # 3016419715A 3103, Best By Date June 16, 2014; Lot # 3017419715A 3103, Best By Date June 17, 2014; Lot # 3018419715A 3103, Best By Date June 18, 2014 & Lot # 3046419715A 3103, Best By Date July 15, 2014.",".","46,813 cs/6/6 oz canisters","The firm was notified via consumer complaints that the product contains mold.",3/11/2013,"03/11/2013",5/15/2013,"05/15/2013"
"Devices",64664,"Ongoing","Elekta, Inc.","Atlanta","GA","US","Voluntary: Firm Initiated","Letter","Nationwide Distribution and Puerto Rico.","Z-1072-2013","Class II","Precise Treatment Table. To be used as part of radiation therapy treatment process.","151855, 151611, 152008, 151587. 151694, 152019, 105864, 105932, 151574, 151267, 152397, 152248, 152559, 151875, 151965, 151369, 152502, 105829, 152262, 151504, 151159, 105941, 151418, 151538, 105990, 151674, 105555, 151729, 151399, 105809, 151802, 151421, 152427, 129032, 105803, 152652. 152659, 152715, 152117, 152803, 151566, 152271, 151736, 151700, 105895, 151866, 151259, 151698, 151699, 151636, 151539, 152454, 151811, 105782, 152425, 151568, 105126, 151390, 152452, 151258, 152491, 105590, 151167, 105853, 105854, 152356, 151584, 105494, 151989, 151522, 151317, 105925, 151055, 151423, 151110, 151981, 151808, 151360, 152801, 151367, 151769, 151969, 105894, 152043, 151391, 151708, 151033, 151809, 151098, 151099, 105841, 152205, 105325, 151763, 151695, 151507, 152703, 105883, 105914, 151238, 151540, 151640, 152777, 152163, 151623, 151627, 151380, 151479, 152331, 152200, 152192, 105481, 151933, 152126, 152115, 152116, 152475, 151422, 152802, 152927, 152123, 151076, 151363, 151954, 105992, 151955, 151340, 105950, 151014, 105273, 152388, 151722, 105154, 105731, 152154, 105284, 151724, 151779, 105644, 152091, 105559, 105844, 151178, 151093, 152585, 105960, 151810, 151467, 151678, 152176, 151051, 151848, 151849, 151411, 151216, 151430, 151173, 151931, 151696, 151616, 151867, 105195, 151141, 151228, 151433, 151977, 105728, 152732, 152833, 105359, 151151, 151714, 105646, 129016, 152815, 152023, 105773, 105260, 105890, 152362, 152359, 152353, 152352, 152433, 105199, 151653, 152303, 152358, 151892, 152223, 152767, 105846, 152881, 151515, 151861, 152618, 105630, 151675, 105591, 151059, 152305, 151325, 152787, 152468, 152031, 152469, 152481, 152601, 151709, 151029, 151886, 151956, 151812, 105929, 151024, 151860, 151523, 105568, 105936, 129029, 151803, 105881, 105261, 105806, 129041, 151885, 105868, 151260, 151519, 151432, 151783, 152175, 152232, 152177, 152365, 151952, 152257, 105528, 152798, 151410, 151084, 105593, 151371, 151305, 105969, 151016, 152220, 151774, 152217, 105926, 151435, 151978, 151387, 151734, 151626, 15184",,"443","The Column rotation can accidentally be moved to a different position which in the locked position.",3/14/2013,"03/14/2013",4/17/2013,"04/17/2013"
"Devices",64665,"Ongoing","Integra Burlington MA, Inc.","Burlington","MA","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution-USA (nationwide) and the countries of Austria, Belgium, Czech Republic, Belgium, Denmark, Spain, Great Britain, Hungary, Ireland, Italy, Netherlands, Poland, Morocco, Netherlands, Poland, Portugal, Saudia Arabia, Sweden, Turkey, and South Africa.","Z-1030-2013","Class II","Integra Ojemann Cortical Stimulator; Product / Catalogue No: OCS2. Intended for intraoperative cortical stimulation mapping procedures. ","Serial Number Range: 1010 through 1380",".","371 units","If the headphone jack is in use during a surgical procedure with the OCS2 and a non-intended voltage (such as static electricity) comes in contact with the outer case of the unit, that voltage could be transmitted to the patient and could be a potential source of injury.",3/18/2013,"03/18/2013",4/10/2013,"04/10/2013"
"Food",64666,"Ongoing","NuGo Nutrition HQ","Oakmont","PA","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Nationwide and Canada.","F-1833-2013","Class I","NuGo Slim Espresso, 1.59 oz (45g) Non-Dairy","Best By date ending in 2012 and 2013 UPC 69153520902 (box) UPC 69153520901 (bar)",".",,"Product may contain undeclared milk product",3/28/2013,"03/28/2013",8/28/2013,"08/28/2013"
"Food",64666,"Ongoing","NuGo Nutrition HQ","Oakmont","PA","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Nationwide and Canada.","F-1829-2013","Class I","NuGo Dark Mint Chocolate Chip, 1.59 oz (45g) Non-Dairy","Best By date ending in 2012 and 2013 UPC 69153552502 (box) UPC 69153552501 (bar)",".",,"Product may contain undeclared milk product",3/28/2013,"03/28/2013",8/28/2013,"08/28/2013"
"Food",64666,"Ongoing","NuGo Nutrition HQ","Oakmont","PA","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Nationwide and Canada.","F-1830-2013","Class I","NuGo Dark Peanut Butter Cup, 1.59 oz (45g) Non-Dairy","Best By date ending in 2012 and 2013 UPC 69153552702 (box) UPC 69153552701 (bar)",".",,"Product may contain undeclared milk product",3/28/2013,"03/28/2013",8/28/2013,"08/28/2013"
"Food",64666,"Ongoing","NuGo Nutrition HQ","Oakmont","PA","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Nationwide and Canada.","F-1826-2013","Class I","NuGo Free Carrot Cake, 1.59 oz (45g) Non-Dairy","Best By 2012 and 2013 UPC 69153545502 (box) UPC 69153545501 (bar)",".",,"Product may contain undeclared milk product",3/28/2013,"03/28/2013",8/28/2013,"08/28/2013"
"Food",64666,"Ongoing","NuGo Nutrition HQ","Oakmont","PA","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Nationwide and Canada.","F-1832-2013","Class I","NuGo Slim Crunchy Peanut Butter, 1.59 oz (45g) Non-Dairy","Best By date ending in 2012 and 2013 UPC 69153520702 (box) UPC 69153520701 (bar)",".",,"Product may contain undeclared milk product",3/28/2013,"03/28/2013",8/28/2013,"08/28/2013"
"Food",64666,"Ongoing","NuGo Nutrition HQ","Oakmont","PA","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Nationwide and Canada.","F-1825-2013","Class I","NuGo Free Dark Chocolate Crunch, 1.59 oz (45g) Non-Dairy","Best By date ending in 2012 and 2013 UPC code 69153545102 (box) UPC code 69153545101 (bar)",".",,"Product may contain undeclared milk product",3/28/2013,"03/28/2013",8/28/2013,"08/28/2013"
"Food",64666,"Ongoing","NuGo Nutrition HQ","Oakmont","PA","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Nationwide and Canada.","F-1831-2013","Class I","NuGo Dark Pretzel 1.59 oz (45g) Non-Dairy Non-Dairy"," Best By date ending in 2012 and 2013 UPC 69153552902 (box) UPC 69153552901 (bar)",".",,"Product may contain undeclared milk product",3/28/2013,"03/28/2013",8/28/2013,"08/28/2013"
"Food",64666,"Ongoing","NuGo Nutrition HQ","Oakmont","PA","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Nationwide and Canada.","F-1827-2013","Class I","NuGo Dark Chocolate Chocolate Chip 1.59 oz (45g) Non-Dairy"," Best By date ending in 2012 and 2013 UPC 69153552102 (box) UPC 69153552101 (bar)",".",,"Product may contain undeclared milk product",3/28/2013,"03/28/2013",8/28/2013,"08/28/2013"
"Food",64666,"Ongoing","NuGo Nutrition HQ","Oakmont","PA","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Nationwide and Canada.","F-1824-2013","Class I","NuGo Free Dark Chocolate Trail Mix Bar, 1.59 oz (45g) Non-Dairy","Best By date ending in 2012 and 2013 UPC code 691535453012 (box) UPC code 69153545301 (bar) ",".",,"Product may contain undeclared milk product",3/28/2013,"03/28/2013",8/28/2013,"08/28/2013"
"Food",64666,"Ongoing","NuGo Nutrition HQ","Oakmont","PA","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Nationwide and Canada.","F-1828-2013","Class I","NuGo Dark Mocha, 1.59 oz (45g) Non-Dairy","Best By date ending in 2012 and 2013 UPC code 69153552302 (box) UPC code 69153552301 (bar)",".",,"Product may contain undeclared milk product",3/28/2013,"03/28/2013",8/28/2013,"08/28/2013"
"Devices",64667,"Terminated","Toshiba American Medical Systems Inc","Tustin","CA","US","Voluntary: Firm Initiated","Letter","Nationwide Distribution including the states of WA, OH, CA, TX, WV, IL, AZ, CA, WI, ME, WI, NC, FL, MT, and HI.","Z-1067-2013","Class II","T SX-IOI: AQUILION 32/64; System, X-Ray, Tomography, Computed. Designed to produce cross-sectional images of a human body. ","Serial Numbers:HDA0722595 JDA0972130 JDA0972135 JDA0992147 JDA09Y2158 KDA09X2063 JDA09Y2157 JDA09Y2161 JDA1012171 JDA10X2191 JDA10X2197 JDA10Z2214 JGAl112220 JLA1122232 JLA1132235 JDAl112216 JDAl112219 NLA0972032 JDA1182242 JDA1182241 JDA1182244 JDA1072183 JDA1082189 ",,"23 units","It was found that in vHP scan, the estimated DLP (total exposure dose of all scans in a singleexamination) value displayed in the eXam Plan window in scan planning and the DLP value displayed in the summary after scanning are incorrect.",11/30/2011,"11/30/2011",4/17/2013,"04/17/2013"
"Devices",64669,"Ongoing","Smith & Nephew Inc","Memphis","TN","US","Voluntary: Firm Initiated","E-Mail","Nationwide Distribution including CA, FL, GA, MA, MI, NC, SC, OH, and MO.","Z-1132-2013","Class II","TRIGEN (TM) L-P SCREW, 4.5 MM X 37.5 MM, TI-6AL-4V, QTY: (1), STERILE R, REF 71645437, Smith & Nephew, Inc. Memphis, TN 38116 USA orthopedic surgery","Lot Number 12FM12182",".","23 units","One batch of 4.5 mm diameter Trigen Low-Profile Bone Screws were incorrectly anodized with a gold coating (indicating a 5 mm diameter) instead of a gray coating (indicating a 4.5 mm diameter).",3/6/2013,"03/06/2013",4/24/2013,"04/24/2013"
"Devices",64670,"Ongoing","Toshiba American Medical Systems Inc","Tustin","CA","US","Voluntary: Firm Initiated","Letter","USA Nationwide Distribution including the states of : IL, NH, MA, MI, MO, PR, NV, NM, MN, ID, NY, OH, NC, AZ, MS, LA, OR, PA, CA, and CT.","Z-1101-2013","Class II","MRT-1504/A4 - Titan X MRI SystemMRT-30 I0A/5 - Titan 3T MRI System Product Usage: MRI System.","The majority ofthe letters are sent via USPS return receipt mail. The letter contains a return reply formthat is to be faxed to TAMS for retention. After two weeks contact will be made with each nonresponding location and a copy ofthe letter will be faxed to that location and the fax receipt will serve as proof ofnotification.",,"27 units","It was found that there is a problem with the LCD monitor used in the console. The LCD monitor maybecome blank during use. Specifically, the backlight of the LCD monitor may turn off while the system is in use, causing the LCD monitor to become blank. However, the other parts of the system continue to operate normally, and the risk of a serious health hazard is therefore very low. The LCD Monitor will be replaced with a new monitor.",10/15/2012,"10/15/2012",4/17/2013,"04/17/2013"
"Devices",64671,"Ongoing","Alere San Diego, Inc.","San Diego","CA","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution-USA (nationwide) and the countries of Canada, South Africa, Netherlands, Italy, Brazil, Singapore, Russia, Hong Kong, Argentina, South Korea, Philippines, El Salvador, Indonesia, and Trinidad.","Z-1139-2013","Class II","Alere Cholestech LDX ALT AST Test Cassette, Model #12-788. For the in vitro quantitative determination of alanine aminotransferase (ALT) and aspartate aminotransferase (AST).","Lot/Unit Codes: 274351A, 274351B, 274352B, 274353A, 290243A, 290244A, 290641A, 290641B, 290642A, 290643A, 290643B, 290644A, 290644B, 290645A, 290645B, 290646A, 290647A, 290648A, 293669A, 293670A, 293671A, 293672A, 293673A, 296635A, 296636A, 296637A, 296638A, 296639A, 296639B, 296640A, 296641A, 296642A, 297311B, 297313A, 297313B.",".","38,571 kits","The recall was initiated because Alere San Diego has an update for the Alere Cholestech LDX ALT AST cassette, and it has the potential for humidity changes to impact results for certain analytes on the Alere Cholestech LDX System.",3/6/2013,"03/06/2013",4/24/2013,"04/24/2013"
"Food",64672,"Ongoing","Magno Humphries Inc","Tigard","OR","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Distributed to only one consignee with several locations nationwide.","F-1304-2013","Class III","Ferrous Sulfate Tablets 325 mg, 100 count bottles, Nutritional Supplement. Label reads in part ''OPTIMUM *** FERROUS SULFATE 325 * mg 5 Grain *** Gluten Free Dietary Supplement *** Manufactured & Distributed by: Magno-Humphries Labs Tigard, OR 97223 U.S.A. *** *325 mg calculated as Ferrous Sulfate Heptahydrate. ***'' UPC 0 43292 56306 0 There are 72 bottles per shipping case and most product is shipped by case.","Product code -L6430-100-01(L is designate label, 6430 is the firm's internal product code, 100 is for 100 count and 01 stands for Optimum label, and 0 is the firm's version number. All of these products have the same label code, however; they have different lot numbers. Lot Numbers: 343617, 343718, 343739, 343753, 343814, 343888, and 343959. Expiration dates 11/15, 12/15, 12/15, 12/15, 12/15, 1/16 and 1/16 respectively (expiration dates are month and year) The lot number and expiration date is stamped on the bottom of the bottles.",,"40369 bottles","The firm found minute pieces of blue material identified by their raw material supplier as polypropylene, a relatively inert plastic.",3/18/2013,"03/18/2013",4/17/2013,"04/17/2013"
"Devices",64673,"Terminated","Toshiba American Medical Systems Inc","Tustin","CA","US","Voluntary: Firm Initiated","Letter","Distributed in the state of MD.","Z-1068-2013","Class II","Toshiba TSX-30IC AQUlLlON ONE System, Computed Tomography X-Ray. This system supports Whole body scanning.","Serial No: 1CB1262006",,"1 unit","It has been found that due to a problem with the control software of the x-ray high-voltage generator, if scanning is performed with a tube current less than 30mA, the control software may detect an error and perform error processing even though the x-ray output is normal.",11/14/2012,"11/14/2012",4/17/2013,"04/17/2013"
"Devices",64674,"Terminated","Toshiba American Medical Systems Inc","Tustin","CA","US","Voluntary: Firm Initiated","Letter","USA nationwide. No international.","Z-0994-2013","Class II","Toshiba Infinix-i X-Ray System. A radiographic and fluoroscopic x-ray system for use in diagnostic and angiographic procedures. ","NO. SERIAL NO. LASTFOUR MANUFACTURE DATE 1 A3SS2014 2014 MAY 2003 2 UVBlOS2001 2001 MAY 2010 3 USC1062001 2001 JUNE 2010 4 U4A09X2002 2002 OctOBER 2009 5 U4A09Y2003 2003 NOVEMBER 2009 6 U4A10X2006 2006 OctOBER 2010 7 UEA1072003 2003 JULY 2010 8 UDA09X2002 X2002 SEPTEMBER 2009 9 UCA1092005 2005 SEPTEMBER 2010 10 U4B0992006 2006 SEPTEMBER 2009 11 U4A1012004 2004 JANUARY 2010 12 UCA10S2006 2006 MAY 2010 13 UEA09Y2002 2002 NOVEMBER 2009 14 W2A1012082 2082 JANUARY 2010 15 W1C0652303 2303 MAY 2006 16 UDA0952001 2001 MAY 2009 17 UDA0952002 2002 MAY 2009 18 UUA1042011 2011 APRil 2010 19 UCA1022003 2003 FEBRUARY 2010 20 UKA1022007 2007 FEBRUARY 2010 21 U4B1062007 2007 JUNE 2010 22 A3592048 2048 SEPTEMBER 2003 23 UDA09Z2005 2005 DECEMBER 2009 24 UUA09Y2004 2004 NOVEMBER 2009 25 UUA09Y2005 2005 NOVEMBER 2009 26 U6A0992002 2002 SEPTEMBER 2009 27 W1D07Z2456 2456 DECEMBER 2007 28 U4A1042005 2005 APRil 2010 29 UUA1052012 2012 MAY 2010 30 U7BlOS2001 2001 MAY 2010 31 UKA09Z2005 2005 DECEMBER 2009 32 A3S32005 2005 MARCH 2003 33 UCA1062007 2007 JUNE 2010 34 UTA1092003 2003 SEPTEMBER 2010 35 UCA09Z2002 2002 DECEMBER 2009 36 U6A1072009 2009 JULY 2010 37 U4B0982005 2005 AUGUST 2009 38 U4B0972004 2004 JULY2009 39 W1D0752394 2394 MAY 2007 40 UFB1042002 2002 APRil 2010 41 UDB1072007 2007 JULY 2010 42 UCA0972001 2001 JULY 2009 43 UCA0972001 2001 JULY 2009 44 W1D0722373 2373 FEBRUARY 2007 45 U6A1062008 2008 JUN",,"95 units","Lost and incorrect images. When using the ''F-Rec'' fluoroscopy image acquisition recording option in the ''manual mode'' an infrequent software error may cause images from another study to be displayed on the monitor. The acquired images may be lost requiring additional image acquisitions to be performed.",11/8/2012,"11/08/2012",4/3/2013,"04/03/2013"
"Devices",64675,"Ongoing","Siemens Medical Solutions USA, Inc","Martinez","CA","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution","Z-1039-2013","Class II","SIEMENS brand COHERENCE RT Therapist versions RTT MR1.5, RTT 2.1/2.1A and RTT 2.2/ 2.2B; Software release for COHERENCE Therapist 2.3 for Primus and Oncor Linear Accelerators; Model: COHERENCE TH 2.0, Part No. 8139839, Current R630; Product Usage: The intended use of the SIEMENS branded ONCOR and PRIMUS family of linear accelerator systems is to deliver X-ray photon and electron radiation for the therapeutic treatment of cancer. ","All units of these models.",".","621 units (foreign account) in total","Siemen's issued a Customer Information Letter under Update Instruction TH016/12S to alert all its affected customers of the software issues. The software release is a result of the final system testing addressing multiple performance defects and several safety issues that were not considered critical (for immediate correction) for the safe use of the device. ",3/5/2013,"03/05/2013",4/10/2013,"04/10/2013"
"Devices",64675,"Ongoing","Siemens Medical Solutions USA, Inc","Martinez","CA","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution","Z-1043-2013","Class II","SIEMENS brand COHERENCE RT Therapist versions RTT MR1.5, RTT 2.1/2.1A and RTT 2.2/ 2.2B; Software release for COHERENCE Therapist 2.3 for Primus and Oncor Linear Accelerators; Model: Primeview 3i 2.1, Part No. 8147675, Current R640; Product Usage: The intended use of the SIEMENS branded ONCOR and PRIMUS family of linear accelerator systems is to deliver X-ray photon and electron radiation for the therapeutic treatment of cancer. ","All units of these models.",".","621 units (foreign account) in total","Siemen's issued a Customer Information Letter under Update Instruction TH016/12S to alert all its affected customers of the software issues. The software release is a result of the final system testing addressing multiple performance defects and several safety issues that were not considered critical (for immediate correction) for the safe use of the device. ",3/5/2013,"03/05/2013",4/10/2013,"04/10/2013"
"Devices",64675,"Ongoing","Siemens Medical Solutions USA, Inc","Martinez","CA","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution","Z-1036-2013","Class II","SIEMENS brand COHERENCE RT Therapist versions RTT MR1.5, RTT 2.1/2.1A and RTT 2.2/ 2.2B; Software release for COHERENCE Therapist 2.3 for Primus and Oncor Linear Accelerators; Model: COHERENCE AG TH, Part No. 5863506, Current R630; Product Usage: The intended use of the SIEMENS branded ONCOR and PRIMUS family of linear accelerator systems is to deliver X-ray photon and electron radiation for the therapeutic treatment of cancer. ","All units of these models.",".","621 units (foreign account) in total","Siemen's issued a Customer Information Letter under Update Instruction TH016/12S to alert all its affected customers of the software issues. The software release is a result of the final system testing addressing multiple performance defects and several safety issues that were not considered critical (for immediate correction) for the safe use of the device. ",3/5/2013,"03/05/2013",4/10/2013,"04/10/2013"
"Devices",64675,"Ongoing","Siemens Medical Solutions USA, Inc","Martinez","CA","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution","Z-1038-2013","Class II","SIEMENS brand COHERENCE RT Therapist versions RTT MR1.5, RTT 2.1/2.1A and RTT 2.2/ 2.2B; Software release for COHERENCE Therapist 2.3 for Primus and Oncor Linear Accelerators; Model: COHERENCE Impression TH, Part No. 7341410, Current R630; Product Usage: The intended use of the SIEMENS branded ONCOR and PRIMUS family of linear accelerator systems is to deliver X-ray photon and electron radiation for the therapeutic treatment of cancer. ","All units of these models.",".","621 units (foreign account) in total","Siemen's issued a Customer Information Letter under Update Instruction TH016/12S to alert all its affected customers of the software issues. The software release is a result of the final system testing addressing multiple performance defects and several safety issues that were not considered critical (for immediate correction) for the safe use of the device. ",3/5/2013,"03/05/2013",4/10/2013,"04/10/2013"
"Devices",64675,"Ongoing","Siemens Medical Solutions USA, Inc","Martinez","CA","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution","Z-1041-2013","Class II","SIEMENS brand COHERENCE RT Therapist versions RTT MR1.5, RTT 2.1/2.1A and RTT 2.2/ 2.2B; Software release for COHERENCE Therapist 2.3 for Primus and Oncor Linear Accelerators; Model: COHERENCE TH 2.2, Part No. 10568431, Current R640; Product Usage: The intended use of the SIEMENS branded ONCOR and PRIMUS family of linear accelerator systems is to deliver X-ray photon and electron radiation for the therapeutic treatment of cancer. ","All units of these models.",".","621 units (foreign account) in total","Siemen's issued a Customer Information Letter under Update Instruction TH016/12S to alert all its affected customers of the software issues. The software release is a result of the final system testing addressing multiple performance defects and several safety issues that were not considered critical (for immediate correction) for the safe use of the device. ",3/5/2013,"03/05/2013",4/10/2013,"04/10/2013"
"Devices",64675,"Ongoing","Siemens Medical Solutions USA, Inc","Martinez","CA","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution","Z-1042-2013","Class II","SIEMENS brand COHERENCE RT Therapist versions RTT MR1.5, RTT 2.1/2.1A and RTT 2.2/ 2.2B; Software release for COHERENCE Therapist 2.3 for Primus and Oncor Linear Accelerators; Model: Primeview 3i, Part No. 7341428, Current R610/R630; Product Usage: The intended use of the SIEMENS branded ONCOR and PRIMUS family of linear accelerator systems is to deliver X-ray photon and electron radiation for the therapeutic treatment of cancer. ","All units of these models.",".","621 units (foreign account) in total","Siemen's issued a Customer Information Letter under Update Instruction TH016/12S to alert all its affected customers of the software issues. The software release is a result of the final system testing addressing multiple performance defects and several safety issues that were not considered critical (for immediate correction) for the safe use of the device. ",3/5/2013,"03/05/2013",4/10/2013,"04/10/2013"
"Devices",64675,"Ongoing","Siemens Medical Solutions USA, Inc","Martinez","CA","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution","Z-1037-2013","Class II","SIEMENS brand COHERENCE RT Therapist versions RTT MR1.5, RTT 2.1/2.1A and RTT 2.2/ 2.2B; Software release for COHERENCE Therapist 2.3 for Primus and Oncor Linear Accelerators; Model: COHERENCE TH, Part No. 7339125, - Current R630; Product Usage: The intended use of the SIEMENS branded ONCOR and PRIMUS family of linear accelerator systems is to deliver X-ray photon and electron radiation for the therapeutic treatment of cancer. ","All units of these models.",".","621 units (foreign account) in total","Siemen's issued a Customer Information Letter under Update Instruction TH016/12S to alert all its affected customers of the software issues. The software release is a result of the final system testing addressing multiple performance defects and several safety issues that were not considered critical (for immediate correction) for the safe use of the device. ",3/5/2013,"03/05/2013",4/10/2013,"04/10/2013"
"Devices",64675,"Ongoing","Siemens Medical Solutions USA, Inc","Martinez","CA","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution","Z-1044-2013","Class II","SIEMENS brand COHERENCE RT Therapist versions RTT MR1.5, RTT 2.1/2.1A and RTT 2.2/ 2.2B; Software release for COHERENCE Therapist 2.3 for Primus and Oncor Linear Accelerators; Model: Primeview 3i 2.0, Part No. 8139847, Current R630; Product Usage: The intended use of the SIEMENS branded ONCOR and PRIMUS family of linear accelerator systems is to deliver X-ray photon and electron radiation for the therapeutic treatment of cancer. ","All units of these models.",".","621 units (foreign account) in total","Siemen's issued a Customer Information Letter under Update Instruction TH016/12S to alert all its affected customers of the software issues. The software release is a result of the final system testing addressing multiple performance defects and several safety issues that were not considered critical (for immediate correction) for the safe use of the device. ",3/5/2013,"03/05/2013",4/10/2013,"04/10/2013"
"Devices",64675,"Ongoing","Siemens Medical Solutions USA, Inc","Martinez","CA","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution","Z-1040-2013","Class II","SIEMENS brand COHERENCE RT Therapist versions RTT MR1.5, RTT 2.1/2.1A and RTT 2.2/ 2.2B; Software release for COHERENCE Therapist 2.3 for Primus and Oncor Linear Accelerators; Model: COHERENCE TH 2.1, Part No. 8147667, Current R640; Product Usage: The intended use of the SIEMENS branded ONCOR and PRIMUS family of linear accelerator systems is to deliver X-ray photon and electron radiation for the therapeutic treatment of cancer. ","All units of these models.",".","621 units (foreign account) in total","Siemen's issued a Customer Information Letter under Update Instruction TH016/12S to alert all its affected customers of the software issues. The software release is a result of the final system testing addressing multiple performance defects and several safety issues that were not considered critical (for immediate correction) for the safe use of the device. ",3/5/2013,"03/05/2013",4/10/2013,"04/10/2013"
"Drugs",64676,"Ongoing","Precision Dose Inc.","South Beloit","IL","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Nationwide and Puerto Rico","D-250-2013","Class II","Children's Acetaminophen Oral Suspension, 650 mg/20.3 mL unit dose cup (NDC 68094-650-59), packaged in 30-count cups per shipper case (NDC 68094-650-62), Pkg. By: Precision Dose, Inc., S. Beloit, IL 61080.","Lot #: 101456, Exp 05/13; 101488, Exp 06/13: 101499, 101503, Exp 07/13; 101537, 101552, 101554, Exp 08/13; 101611, 101616, 101623, Exp 10/13; 101630, Exp 11/13; 101754, Exp 03/14",".","9,268 cases","Labeling: Not Elsewhere Classified: This unit dose product is being recalled because the product's name includes the word ''Children's'' which is misleading since the 650 mg dose of acetaminophen contained within it, is an adult dose.",3/21/2013,"03/21/2013",4/24/2013,"04/24/2013"
"Biologics",64677,"Terminated","International Biologics LLC","Scottsdale","AZ","US","Voluntary: Firm Initiated","Telephone","Nevada; Ohio; Texas","B-1430-13","Class III","Bone","IBM1259119006; IBM1259119007; IBM1259119008; IBM1259119009; IBM1259119010; IBM1259119011; IBM1259119012; IBM1259119013; IBM1259119014; IBM1259119015; IBM1259119016; IBM1259119017; IBM1259119018; IBM1259119019; IBM1259119020",".","15 allografts","Human tissue allografts were processed in a manner that could cause contamination or cross-contamination during processing, as well as the introduction, transmission, or spread of communicable disease through the use of the HCT/P.",3/12/2013,"03/12/2013",5/15/2013,"05/15/2013"
"Devices",64678,"Ongoing","Siemens Medical Solutions USA, Inc","Malvern","PA","US","Voluntary: Firm Initiated","Letter","Nationwide Distribution including the states of CA, FL, GA, IA, IN, KS, LA, ME, MI, MO, NC, NH, NJ, NY, NV, OH, PA, TN, TX, VA and WA.","Z-1097-2013","Class II","Iconos R200 C20, Iconos R200 T20, Iconos R100, Iconos MD, Iconos RHD, Luminos RF Classic, Luminos Fusion or Luminos Select. Angiographic x-ray system.","Model Number 5902767 with serial numbers 2217, 2038, 1228, 1007, 1219, 2156, 2264, 2190, 2132, 2213, 1484, 2166, 2259, 2068, 1610, 1601, 1413, 2236, 2153, 1444, 1477, 1632, 2037, 2180, 1663, and 1612; Model Number 5902783 with serial numbers 1003, 1401, 1402, and 1405; Model Number 7152478 with serial numbers 2580, 2524, 2590, 2536, 2563, and 2534; Model Number 10093962 with serial numbers 5837, 5120, 5523, 5910, 5507, 6141, 4112, 6274, 4506, 5900, 4121, 6245, 6242, 4509, and 6113.",,"51","Siemens has become aware of a potential malfunction and possible hazard to patients and staff when using the Iconos R200 C20, Iconos R200 T20, Iconos R100, Iconos MD, Iconos RHD, Luminos RF Classic, Luminos Fusion or Luminos Select. This malfunction is possible in cases where the table vertical lift movement is obstructed by a solid object which could potentially result in collision. This can result in damage to system mechanics that may not necessarily prevent the table from functioning immediately, but can lead to complete failure of the table mounting mechanics. It is possible that the table may drop, resulting in potentially hazardous situations for patients and/or staff.",1/15/2013,"01/15/2013",4/17/2013,"04/17/2013"
"Devices",64679,"Ongoing","Biomet U.K., Ltd.","Bridgend, South Wales",,"GB","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Worldwide Distribution - USA (nationwide), Europe, Japan, Australia, Canada, Singapore, South Africa, and Costa Rica.","Z-1124-2013","Class II","REF 32-422760 Oxford Uni Knee System,Toffee Hammer, non-sterile, found in REF 32-422763 Oxford Mlcroplasty Knee System Tibial instrument Tray small surgical hammer supplied with the Oxford Partial Knee Microplasty Instrument set, used for impacting implants.","32-422760 ( sold as part of instrument set 32-422763 ) ZB100901,ZB110201,ZB110301,ZB110302,ZB110303, ZB110304,ZB110601,ZB110602,ZB110701,ZB111201, ZB111202,ZB120201,ZB120202,ZB120701,ZB120801, ZB120802,ZB121102,ZB121103",".","430","Investigation of complaints found excessive use of the instrument could result in cracking on the weld between the head and the handle, which could lead to part of the head becoming detached from the handle.",3/20/2013,"03/20/2013",4/24/2013,"04/24/2013"
"Drugs",64680,"Ongoing","Teva Pharmaceuticals USA, Inc.","Sellersville","PA","US","Voluntary: Firm Initiated","Letter","Nationwide","D-578-2013","Class III","Disulfiram Tablets USP 250 mg, 100 tablet bottle, Rx only, Manufactured for TEVA Pharmaceuticals, USA, Sellersville, PA --- NDC 0093-5035-01","NDC 0093-5035-01, Lot numbers 14064211A, exp 3/2014; 14064311A, exp 3/2014; 14064411A, exp 3/2014; 14064511A, exp 3/2014; 14090312A, exp 4/2015; 14092512A, exp 4/2015; 14092712A, exp 4/2015; 14094612A, exp 4/2015; 14099412A, exp 4/2015; 14099612B, exp 4/2015; 14099712A, exp 5/2015; 14110111A, exp 5/2014; 14110211A, exp 5/2014; 14110311A, exp 5/2014; 14110411A, exp 5/2014 and 34090212A, exp 4/2015.",".","68,322 bottles","CGMP Deviation; cotton coil is missing in some packaged bottles",3/19/2013,"03/19/2013",6/12/2013,"06/12/2013"
"Food",64681,"Ongoing","Daesang America Inc","Hackensack","NJ","US","Voluntary: Firm Initiated","Telephone","Nationwide","F-1301-2013","Class I","Sunchang Ssamjang Sesame and Garlic Seasoned Bean Paste 500 g - Net Wt. 17.64 oz., UPC Code 880152435671 Distributed by: Daesang America, Inc. Hackensack, NJ 07601 TEL: (201) 488-4010 Product of Korea","All expiration dates. Recalled product was distributed from June 2012 to Feb. 2013.",,"1070 cartons","Sesame and Garlic Flavored Mixed Soy Bean Paste contains peanut powder which is included in the Korean ingredient listing but not the English ingredient listing.",3/13/2013,"03/13/2013",4/17/2013,"04/17/2013"
"Devices",64682,"Ongoing","Stryker Endoscopy","San Jose","CA","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution: USA (nationwide) and countries of: Mexico, Portugal, Latin America, India, Greece, Taiwan, Singapore, New Zealand, Phillipines, Netherlands, France, Australia, Canada, Japan, Scandinavia, Iberia, Brasil, Romania, South Africa, Chile, Korea, China.","Z-1235-2013","Class II","Stryker Irrigator Reusable Tips: 5mm X 32cm Regular Tip with No Holes, Non-Reflective Finish. Suction irrigator tips aid in cleaning and clearing the operative site during laparoscopic surgery.","Manufacturer Part Number: 250-070-489",".","147,921 - all sizes","The pre-vacuum steam sterilization (wrapped method) temperature in the Instructions for Use incorrectly listed 121-123C , instead of the correct 132-133C.",3/27/2013,"03/27/2013",5/15/2013,"05/15/2013"
"Devices",64682,"Ongoing","Stryker Endoscopy","San Jose","CA","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution: USA (nationwide) and countries of: Mexico, Portugal, Latin America, India, Greece, Taiwan, Singapore, New Zealand, Phillipines, Netherlands, France, Australia, Canada, Japan, Scandinavia, Iberia, Brasil, Romania, South Africa, Chile, Korea, China.","Z-1231-2013","Class II","Stryker Irrigator Reusable Tips: 10mm X 32cm Regular Tip, vented, Non-Reflective Finish. Suction irrigator tips aid in cleaning and clearing the operative site during laparoscopic surgery.","Manufacturer Part Number: 250-070-484",".","147,921 - all sizes","The pre-vacuum steam sterilization (wrapped method) temperature in the Instructions for Use incorrectly listed 121-123C , instead of the correct 132-133C.",3/27/2013,"03/27/2013",5/15/2013,"05/15/2013"
"Devices",64682,"Ongoing","Stryker Endoscopy","San Jose","CA","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution: USA (nationwide) and countries of: Mexico, Portugal, Latin America, India, Greece, Taiwan, Singapore, New Zealand, Phillipines, Netherlands, France, Australia, Canada, Japan, Scandinavia, Iberia, Brasil, Romania, South Africa, Chile, Korea, China.","Z-1232-2013","Class II","Stryker Irrigator Reusable Tips: 5mm X 32cm Hydrodissection Tip, Non-Reflective Finish. Suction irrigator tips aid in cleaning and clearing the operative site during laparoscopic surgery.","Manufacturer Part Number: 250-070-487",".","147,921 - all sizes","The pre-vacuum steam sterilization (wrapped method) temperature in the Instructions for Use incorrectly listed 121-123C , instead of the correct 132-133C.",3/27/2013,"03/27/2013",5/15/2013,"05/15/2013"
"Devices",64682,"Ongoing","Stryker Endoscopy","San Jose","CA","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution: USA (nationwide) and countries of: Mexico, Portugal, Latin America, India, Greece, Taiwan, Singapore, New Zealand, Phillipines, Netherlands, France, Australia, Canada, Japan, Scandinavia, Iberia, Brasil, Romania, South Africa, Chile, Korea, China.","Z-1218-2013","Class II","Stryker Irrigator Reusable Tips: 5mm X 32cm Regular Tip, Vented, Metal Finish. Suction irrigator tips aid in cleaning and clearing the operative site during laparoscopic surgery. ","Manufacturer Part Number: 250-070-403",".","147,921 - all sizes","The pre-vacuum steam sterilization (wrapped method) temperature in the Instructions for Use incorrectly listed 121-123C , instead of the correct 132-133C.",3/27/2013,"03/27/2013",5/15/2013,"05/15/2013"
"Devices",64682,"Ongoing","Stryker Endoscopy","San Jose","CA","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution: USA (nationwide) and countries of: Mexico, Portugal, Latin America, India, Greece, Taiwan, Singapore, New Zealand, Phillipines, Netherlands, France, Australia, Canada, Japan, Scandinavia, Iberia, Brasil, Romania, South Africa, Chile, Korea, China.","Z-1224-2013","Class II","Stryker Irrigator Reusable Tips: 5mm X 24cm Regular Tip, Vented, Metal Finish. Suction irrigator tips aid in cleaning and clearing the operative site during laparoscopic surgery.","Manufacturer Part Number: 250-070-411",".","147,921 - all sizes","The pre-vacuum steam sterilization (wrapped method) temperature in the Instructions for Use incorrectly listed 121-123C , instead of the correct 132-133C.",3/27/2013,"03/27/2013",5/15/2013,"05/15/2013"
"Devices",64682,"Ongoing","Stryker Endoscopy","San Jose","CA","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution: USA (nationwide) and countries of: Mexico, Portugal, Latin America, India, Greece, Taiwan, Singapore, New Zealand, Phillipines, Netherlands, France, Australia, Canada, Japan, Scandinavia, Iberia, Brasil, Romania, South Africa, Chile, Korea, China.","Z-1233-2013","Class II","Stryker Irrigator Reusable Tips: 5mm X 45cm Regular Tip, vented, Non-Reflective Finish. Suction irrigator tips aid in cleaning and clearing the operative site during laparoscopic surgery.","Manufacturer Part Number: 250-070-488",".","147,921 - all sizes","The pre-vacuum steam sterilization (wrapped method) temperature in the Instructions for Use incorrectly listed 121-123C , instead of the correct 132-133C.",3/27/2013,"03/27/2013",5/15/2013,"05/15/2013"
"Devices",64682,"Ongoing","Stryker Endoscopy","San Jose","CA","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution: USA (nationwide) and countries of: Mexico, Portugal, Latin America, India, Greece, Taiwan, Singapore, New Zealand, Phillipines, Netherlands, France, Australia, Canada, Japan, Scandinavia, Iberia, Brasil, Romania, South Africa, Chile, Korea, China.","Z-1236-2013","Class II","Stryker Irrigator Reusable Tips: 3mm X 32cm Regular Tip, Vented, Metal Finish. Suction irrigator tips aid in cleaning and clearing the operative site during laparoscopic surgery.","Manufacturer Part Number: 250-070-490",".","147,921 - all sizes","The pre-vacuum steam sterilization (wrapped method) temperature in the Instructions for Use incorrectly listed 121-123C , instead of the correct 132-133C.",3/27/2013,"03/27/2013",5/15/2013,"05/15/2013"
"Devices",64682,"Ongoing","Stryker Endoscopy","San Jose","CA","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution: USA (nationwide) and countries of: Mexico, Portugal, Latin America, India, Greece, Taiwan, Singapore, New Zealand, Phillipines, Netherlands, France, Australia, Canada, Japan, Scandinavia, Iberia, Brasil, Romania, South Africa, Chile, Korea, China.","Z-1222-2013","Class II","Stryker Irrigator Reusable Tips: 5mm X 45cm Regular Tip, Vented, Metal Finish. Suction irrigator tips aid in cleaning and clearing the operative site during laparoscopic surgery.","Manufacturer Part Number: 250-070-408.",".","147,921 - all sizes","The pre-vacuum steam sterilization (wrapped method) temperature in the Instructions for Use incorrectly listed 121-123C , instead of the correct 132-133C.",3/27/2013,"03/27/2013",5/15/2013,"05/15/2013"
"Devices",64682,"Ongoing","Stryker Endoscopy","San Jose","CA","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution: USA (nationwide) and countries of: Mexico, Portugal, Latin America, India, Greece, Taiwan, Singapore, New Zealand, Phillipines, Netherlands, France, Australia, Canada, Japan, Scandinavia, Iberia, Brasil, Romania, South Africa, Chile, Korea, China.","Z-1237-2013","Class II","Stryker Irrigator Reusable Tips: 3mm X 32cm Regular Tip, Non-Vented, Metal Finish. Suction irrigator tips aid in cleaning and clearing the operative site during laparoscopic surgery.","Manufacturer Part Number: 250-070-491",".","147,921 - all sizes","The pre-vacuum steam sterilization (wrapped method) temperature in the Instructions for Use incorrectly listed 121-123C , instead of the correct 132-133C.",3/27/2013,"03/27/2013",5/15/2013,"05/15/2013"
"Devices",64682,"Ongoing","Stryker Endoscopy","San Jose","CA","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution: USA (nationwide) and countries of: Mexico, Portugal, Latin America, India, Greece, Taiwan, Singapore, New Zealand, Phillipines, Netherlands, France, Australia, Canada, Japan, Scandinavia, Iberia, Brasil, Romania, South Africa, Chile, Korea, China.","Z-1220-2013","Class II","Stryker Irrigator Reusable Tips: 10mm X 32cm Pool Suction Tip, Metal Finish. Suction irrigator tips aid in cleaning and clearing the operative site during laparoscopic surgery.","Manufacturer Part Number: 250-070-404.",".","147,921 - all sizes","The pre-vacuum steam sterilization (wrapped method) temperature in the Instructions for Use incorrectly listed 121-123C , instead of the correct 132-133C.",3/27/2013,"03/27/2013",5/15/2013,"05/15/2013"
"Devices",64682,"Ongoing","Stryker Endoscopy","San Jose","CA","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution: USA (nationwide) and countries of: Mexico, Portugal, Latin America, India, Greece, Taiwan, Singapore, New Zealand, Phillipines, Netherlands, France, Australia, Canada, Japan, Scandinavia, Iberia, Brasil, Romania, South Africa, Chile, Korea, China.","Z-1225-2013","Class II","Stryker Irrigator Reusable Tips: 5mm X 32cm Aspiration Needle Tip. Suction irrigator tips aid in cleaning and clearing the operative site during laparoscopic surgery.","Manufacturer Part Number: 250-070-437",".","147,921 - all sizes","The pre-vacuum steam sterilization (wrapped method) temperature in the Instructions for Use incorrectly listed 121-123C , instead of the correct 132-133C.",3/27/2013,"03/27/2013",5/15/2013,"05/15/2013"
"Devices",64682,"Ongoing","Stryker Endoscopy","San Jose","CA","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution: USA (nationwide) and countries of: Mexico, Portugal, Latin America, India, Greece, Taiwan, Singapore, New Zealand, Phillipines, Netherlands, France, Australia, Canada, Japan, Scandinavia, Iberia, Brasil, Romania, South Africa, Chile, Korea, China.","Z-1230-2013","Class II","Stryker Irrigator Reusable Tips: 5mm X 32cm Regular Tip, vented, Non-Reflective Finish. Suction irrigator tips aid in cleaning and clearing the operative site during laparoscopic surgery.","Manufacturer Part Number: 250-070-483",".","147,921 - all sizes","The pre-vacuum steam sterilization (wrapped method) temperature in the Instructions for Use incorrectly listed 121-123C , instead of the correct 132-133C.",3/27/2013,"03/27/2013",5/15/2013,"05/15/2013"
"Devices",64682,"Ongoing","Stryker Endoscopy","San Jose","CA","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution: USA (nationwide) and countries of: Mexico, Portugal, Latin America, India, Greece, Taiwan, Singapore, New Zealand, Phillipines, Netherlands, France, Australia, Canada, Japan, Scandinavia, Iberia, Brasil, Romania, South Africa, Chile, Korea, China.","Z-1226-2013","Class II","Stryker Irrigator Reusable Tips: 2mm X 32cm Regular Tip with 1 Hole, Metal Finish. Suction irrigator tips aid in cleaning and clearing the operative site during laparoscopic surgery.","Manufacturer Part Number: 250-070-471",".","147,921 - all sizes","The pre-vacuum steam sterilization (wrapped method) temperature in the Instructions for Use incorrectly listed 121-123C , instead of the correct 132-133C.",3/27/2013,"03/27/2013",5/15/2013,"05/15/2013"
"Devices",64682,"Ongoing","Stryker Endoscopy","San Jose","CA","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution: USA (nationwide) and countries of: Mexico, Portugal, Latin America, India, Greece, Taiwan, Singapore, New Zealand, Phillipines, Netherlands, France, Australia, Canada, Japan, Scandinavia, Iberia, Brasil, Romania, South Africa, Chile, Korea, China.","Z-1229-2013","Class II","Stryker Irrigator Reusable Tips: 5mm X 28cm Regular Tip, vented, Non-Reflective Finish. Suction irrigator tips aid in cleaning and clearing the operative site during laparoscopic surgery.","Manufacturer Part Number: 250-070-482",".","147,921 - all sizes","The pre-vacuum steam sterilization (wrapped method) temperature in the Instructions for Use incorrectly listed 121-123C , instead of the correct 132-133C.",3/27/2013,"03/27/2013",5/15/2013,"05/15/2013"
"Devices",64682,"Ongoing","Stryker Endoscopy","San Jose","CA","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution: USA (nationwide) and countries of: Mexico, Portugal, Latin America, India, Greece, Taiwan, Singapore, New Zealand, Phillipines, Netherlands, France, Australia, Canada, Japan, Scandinavia, Iberia, Brasil, Romania, South Africa, Chile, Korea, China.","Z-1228-2013","Class II","Stryker Irrigator Reusable Tips: 2mm X 34cm Regular Tip with No Hole, Metal Finish. Suction irrigator tips aid in cleaning and clearing the operative site during laparoscopic surgery.","Manufacturer Part Number: 250-070-473",".","147,921 - all sizes","The pre-vacuum steam sterilization (wrapped method) temperature in the Instructions for Use incorrectly listed 121-123C , instead of the correct 132-133C.",3/27/2013,"03/27/2013",5/15/2013,"05/15/2013"
"Devices",64682,"Ongoing","Stryker Endoscopy","San Jose","CA","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution: USA (nationwide) and countries of: Mexico, Portugal, Latin America, India, Greece, Taiwan, Singapore, New Zealand, Phillipines, Netherlands, France, Australia, Canada, Japan, Scandinavia, Iberia, Brasil, Romania, South Africa, Chile, Korea, China.","Z-1227-2013","Class II","Stryker Irrigator Reusable Tips: 2mm X 32cm Regular Tip with 2 Hole, Metal Finish. Suction irrigator tips aid in cleaning and clearing the operative site during laparoscopic surgery.","Manufacturer Part Number: 250-070-472",".","147,921 - all sizes","The pre-vacuum steam sterilization (wrapped method) temperature in the Instructions for Use incorrectly listed 121-123C , instead of the correct 132-133C.",3/27/2013,"03/27/2013",5/15/2013,"05/15/2013"
"Devices",64682,"Ongoing","Stryker Endoscopy","San Jose","CA","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution: USA (nationwide) and countries of: Mexico, Portugal, Latin America, India, Greece, Taiwan, Singapore, New Zealand, Phillipines, Netherlands, France, Australia, Canada, Japan, Scandinavia, Iberia, Brasil, Romania, South Africa, Chile, Korea, China.","Z-1234-2013","Class II","Stryker Irrigator Reusable Tips: Vented Tip, 5mm X 45cm Non-Reflective with 30 Downward Bend At Proximal End. Suction irrigator tips aid in cleaning and clearing the operative site during laparoscopic surgery.","Manufacturer Part Number: 250-070-488s2",".","147,921 - all sizes","The pre-vacuum steam sterilization (wrapped method) temperature in the Instructions for Use incorrectly listed 121-123C , instead of the correct 132-133C.",3/27/2013,"03/27/2013",5/15/2013,"05/15/2013"
"Devices",64682,"Ongoing","Stryker Endoscopy","San Jose","CA","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution: USA (nationwide) and countries of: Mexico, Portugal, Latin America, India, Greece, Taiwan, Singapore, New Zealand, Phillipines, Netherlands, France, Australia, Canada, Japan, Scandinavia, Iberia, Brasil, Romania, South Africa, Chile, Korea, China.","Z-1219-2013","Class II","Stryker Irrigator Reusable Tips: 5mm X 32cm Regular Tip, Vented, Metal Finish. Suction irrigator tips aid in cleaning and clearing the operative site during laparoscopic surgery.","Manufacturer Part Number: 250-070-403",".","147,921 - all sizes","The pre-vacuum steam sterilization (wrapped method) temperature in the Instructions for Use incorrectly listed 121-123C , instead of the correct 132-133C.",3/27/2013,"03/27/2013",5/15/2013,"05/15/2013"
"Devices",64682,"Ongoing","Stryker Endoscopy","San Jose","CA","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution: USA (nationwide) and countries of: Mexico, Portugal, Latin America, India, Greece, Taiwan, Singapore, New Zealand, Phillipines, Netherlands, France, Australia, Canada, Japan, Scandinavia, Iberia, Brasil, Romania, South Africa, Chile, Korea, China.","Z-1221-2013","Class II","Stryker Irrigator Reusable Tips: 5mm X 32cm Tip Hydrodissection Tip, Metal Finish. Suction irrigator tips aid in cleaning and clearing the operative site during laparoscopic surgery.","Manufacturer Part Number:250-070-407",".","147,921 - all sizes","The pre-vacuum steam sterilization (wrapped method) temperature in the Instructions for Use incorrectly listed 121-123C , instead of the correct 132-133C.",3/27/2013,"03/27/2013",5/15/2013,"05/15/2013"
"Devices",64682,"Ongoing","Stryker Endoscopy","San Jose","CA","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution: USA (nationwide) and countries of: Mexico, Portugal, Latin America, India, Greece, Taiwan, Singapore, New Zealand, Phillipines, Netherlands, France, Australia, Canada, Japan, Scandinavia, Iberia, Brasil, Romania, South Africa, Chile, Korea, China.","Z-1223-2013","Class II","Stryker Irrigator Reusable Tips: 5mm X 32cm Regular Tip , Non-Vented, Metal Finish. Suction irrigator tips aid in cleaning and clearing the operative site during laparoscopic surgery.","Manufacturer Part Number: 250-070-409",".","147,921 - all sizes","The pre-vacuum steam sterilization (wrapped method) temperature in the Instructions for Use incorrectly listed 121-123C , instead of the correct 132-133C.",3/27/2013,"03/27/2013",5/15/2013,"05/15/2013"
"Devices",64683,"Ongoing","Vital Images, Inc.","Minnetonka","MN","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution - USA including AL, AR, CA, CO, IA, MI,MN, MO, NY, NC, OH, OR, PA, TX, and UT. Internationally to AUSTRIA, BELGIUM, CANADA, CHINA, COLOMBIA, GEORGIA, JAPAN, KOREA, MACEDONIA, NETHERLANDS, POLAND, PORTUGAL, RUSSIAN FEDERATION, SINGAPORE, SWEDEN, SWITZERLAND, TURKEY, UKRAINE, UNITED KINGDOM.","Z-1144-2013","Class II","Vitrea CT Multi-Chamber Cardiac Functional Analysis application on Vitrea version 5.2 (Vitrea Enterprise Suite 1.3 and Vitrea fX 3.1) and subsequent versions of VitreaWorkstation, Vitrea fX, VitreaAdvanced and Vitrea Enterprise Suite, through version 6.4. Vitrea CT Multi-Chamber Cardiac Functional Analysis provides a variety of tools for working with clinical CT images of the coronary arteries, heart, and surrounding tissue. ","Serial Number EMC1112028 EMC1112027 EMC1103020 VMC1302077 VMC1202027 VMC1202028 VMC1202029 VMC1109012 MCH1006002 VMC1109008 VMC1202017 VMC1202026 VMC1202025 VMC1202032 VMC1202019 VMC1202037 VMC1202022 VMC1202023 VMC1202024 VMC1202020 VMC1202021 VMC1105013 VMC1105014 VMC1105015 VMC1109011 VMC1211048 VMC1211049 VMC1202038 VMC1211043 VMC1211044 VMC1211046 VMC1211047 VMC1211045 VMC1302064 VMC1302065 VMC1211040 VMC1302050 VMC1302051 VMC1202018 VMC1109005 VMC1302076 VMC1302075 VMC1109010 VMC1109009 VMC1202034 VMC1202031 VMC1012011 EMC1012014 EMC1012015 EMC1101016 VMC1202033 VMC1202030 EMC1203036 VMC1202015 VMC1109004 VMC1202035 VMC1111013 VMC1211041 EMC1203033 EMC1209041 EMC1203037 VMC1109006 EMC1211043 VMC1109007 EMC1211044 VMC1202039 VMC1202036 VMC1109003 VMC1211042 EMC1212047 EMC1203035 EMC1109025 EMC1203031 EMC1302049 EMC1212048 EMC1201029 EMC1212045 EMC1201030 EMC1110026 VMC1108016 EMC1107022 MCH1006011 EMC1206039 EMC1101017 MCH1006001 EMC1203034 EMC1103018 EMC1103019 EMC1107023 EMC1203032 VMC1202016 EMC1108024 EMC1209042 EMC1206038 EMC1212046 EMC1012011 VMC1201014 EMC1105021 ",".","102","Vital Images has made a decision to perform a field correction to the Vitrea CT Multi-Chamber Cardiac Functional Analysis application. Vital Images has identified a defect in which numerical values may be incorrect in the Results Table under the Cardiac Analysis portion of the user interface.",3/15/2013,"03/15/2013",4/24/2013,"04/24/2013"
"Biologics",64685,"Terminated","Blood Systems, Inc","Fargo","ND","US","Voluntary: Firm Initiated","Telephone","North Dakota","B-1513-13","Class II","Red Blood Cells Leukocytes Reduced","W0425100111425 ",,"1 unit","Blood product, which was incorrectly labeled as negative for the Jk(a) red cell antigen, was distributed",12/16/2012,"12/16/2012",6/26/2013,"06/26/2013"
"Biologics",64686,"Terminated","Hoxworth Blood Center UC Medical Center","Cincinnati","OH","US","Voluntary: Firm Initiated","Letter","Kentucky","B-1514-13","Class II","Red Blood Cells Leukocytes Reduced","W037712067469",,"1 unit","Blood product, which was collected from a donor who traveled to a malarial endemic area, was distributed.",2/1/2013,"02/01/2013",6/26/2013,"06/26/2013"
"Biologics",64687,"Terminated","Hoxworth Blood Center UC Medical Center","Cincinnati","OH","US","Voluntary: Firm Initiated","Letter","Ohio","B-1515-13","Class II","Red Blood Cells Leukocytes Reduced","W037712056303; W037711104912; W037709075794; ",,"3 units","Blood products, which were collected from a donor who traveled to a malarial endemic area, were distributed. ",1/29/2013,"01/29/2013",6/26/2013,"06/26/2013"
"Biologics",64688,"Terminated","Hoxworth Blood Center UC Medical Center","Cincinnati","OH","US","Voluntary: Firm Initiated","Telephone","Ohio","B-1516-13","Class II","Fresh Frozen Plasma","W037712089020",,"1 unit","Blood product, collected from a donor who was at risk for variant Creutzfeldt-Jakob disease (vCJD), was distributed.",1/21/2013,"01/21/2013",6/26/2013,"06/26/2013"
"Devices",64689,"Ongoing","Kimberly-Clark Corporation","Roswell","GA","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Worldwide Distribution -- USA, including the states of AL, AK, AZ, AR, CA, CO, FL, GA, ID, IL, IN, IA, KS, KY, LA, MD, MA, MI, MN, MS, MO, NV, NJ, NM, NY, NC, OH, OK, OR, PA, TN, TX, UT, VA, WA, and WI, and the countries of Canada, Australia, Belgium, Hong Kong, Japan, Portugal, and Singapore.","Z-0995-2013","Class II","KIMGUARD Container Filters, 7.5in (19cm), Round and 9in. X 9in. (23cm x 23cm), Square. Intended to be used to enclose another medical device that is to be sterilized by a health care provider.","Product Code 68507 (Round) Case Lot Numbers MF1284XXX, MF1287XXX, MF1294XXX, MF1316XXX, MF2012XXX, MF2055XXX, MF2086XXX, MF2098XXX, MF2115XXX, MF2146XXX, MF2178XXX, MF2188XXX, MF2196XXX, MF2210XXX, MF2228XXX, MF2243XXX, MF2264XXX, MF2271XXX, MF2285XXX, MF2328XXX, and MF2338XXX. Product Code 68509 (Square) Case Lot Numbers MF1279XXX, MF1287XXX, and MF1288XXX.",,"Code 68507 - 6420 cases; Code 68509 - 1281 cases ","Some individual container filter units might contain thin areas that may potentially compromise the ability of the filter to maintain a sterile barrier.",3/6/2013,"03/06/2013",4/3/2013,"04/03/2013"
"Drugs",64690,"Ongoing","Pfizer Inc.","New York","NY","US","Voluntary: Firm Initiated","Letter","Nationwide","D-219-2013","Class III","TORISEL Kit (temsirolimus) injection, 25 mg/mL, CONCENTRATED, Rx Only, Packaged in a carton containing 1 vial TORISEL injection and 1 vial DILUENT for TORISEL, Distributed by Wyeth Pharmaceuticals Inc., A subsidiary of Pfizer Inc., Philadelphia, PA --- NDC 0008-1179-01","Lots P00025A; P00027B",,"10920 kits","Lack of Assurance of Sterility; potential that a low level of endotoxins may be present in the diluent vials.",11/26/2012,"11/26/2012",4/3/2013,"04/03/2013"
"Food",64691,"Ongoing","Custom Co-Pak, LLC","Philadelphia","PA","US","Voluntary: Firm Initiated","E-Mail","Nationwide and Canada via wholesale distribution and internet sales to consumers","F-1861-2013","Class II","Garbanzo Iced Lemon Grass Ginger Tea 3 oz foil portion packs","Lot #2243",,"70 lbs","Recall is being conducted based on a finding of possible contamination by the supplier of the firms lemongrass.",3/21/2013,"03/21/2013",9/4/2013,"09/04/2013"
"Food",64691,"Ongoing","Custom Co-Pak, LLC","Philadelphia","PA","US","Voluntary: Firm Initiated","E-Mail","Nationwide and Canada via wholesale distribution and internet sales to consumers","F-1862-2013","Class II","Long Life Premium Organic Green Tea with Lemongrass, packages of 18 tea bags, (27 grams/.95 ounces)","Lot number 2165 -- UPC 713757555302 Expiration 6/13/14 (may or may not be printed on the product packaging)",,"4 lbs","Recall is being conducted based on a finding of possible contamination by the supplier of the firm's lemongrass.",3/21/2013,"03/21/2013",9/4/2013,"09/04/2013"
"Devices",64692,"Ongoing","Advanced Sterilization Products","Irvine","CA","US","Voluntary: Firm Initiated","Letter","US Nationwide Distribution","Z-1027-2013","Class II","STERRAD 200 Sterilization System, P/N 10201 Product Usage: The STERRAD 200 Sterilization System is a general purpose, low temperature sterilizer which uses the STERRAD 200 process to inactivate microorganisms on a board range of medical devices and surgical instruments. ","Codes: 10217 10201-002 10201 10202-001 ",".","1038 units","The recall was initiated because Advanced Sterilization Products (ASP) has determined that the STERRAD 100NX and STERRAD 200 Sterilization Systems may emit an odor or smell into the surrounding environment that is not typical to normal operating conditions.",3/22/2013,"03/22/2013",4/10/2013,"04/10/2013"
"Devices",64692,"Ongoing","Advanced Sterilization Products","Irvine","CA","US","Voluntary: Firm Initiated","Letter","US Nationwide Distribution","Z-1026-2013","Class II","STERRAD 100NX Sterilization System, P/N 10104 Product Usage: The STERRAD 100NX Sterilization System is a general purpose, low temperature sterilizer which uses the STERRAD 100NX process to inactivate microorganisms on a board range of medical devices and surgical instruments.","SO Numbers: 601918 601921 653618 658412 658619 663775 663605 670265 670983 676483 676976 677247 682484 683535 683401 685051 684706 684897 689791 693170 688731 695253 685242 695044 694872 694890 694933 700374 700420 687958 695322 698794 694561 696647 694903 697444 703236 704953 705019 704220 704997 684009 705131 705189 705395 706157 707254 707928 709374 710904 705394 710055 710381 711947 712233 712952 711466 713603 714781 714896 714927 714941 715465 714230 714936 715319 715471 680655 711359 715140 704508 715994 716005 715655 716503 716506 716482 716806 716925 716956 716977 717350 716504 717332 717457 717466 717456 717490 716774 717477 717487 717482 717472 716955 723403 718518 724650 717455 727905 717473 732354 726771 733003 733007 732940 735456 736315 736250 742622 742112 742351 740419 739924 747572 746618 746545 747670 747711 748911 734951 752042 752042 755131 752064 754673 755986 755473 755926 756407 756812 756765 756999 721585 760939 761382 761772 761799 761633 761658 761800 763129 764141 765734 761630 766501 766267 766428 767666 768281 771414 771584 774002 773999 760959 747284 776722 776662 776977 773450 777395 777350 766566 777994 778115 778295 778306 778397 778420 780632 779184 784712 784835 789915 790515 792749 793716 794027 797344 798207 801358 801676 801385 805783 806315 806548 806498 806984 806802 808292 808295 808494 808536 809391 809380 797623 810329 817633 798012 825076 828243 830038 830794 831189 836405 837375 838142 839868 839929 817131 839929 840983 840545 841232 809230 842623 842322 843316 843497 823885 819965 843666 843851 843787 818045 843499 844166 844051 844190 845657 844485 848549 849523 849499 849527 849527 849499 851457 852003 849523 852405 856503 859597 860435 861720 861917 862005 863791 863870 864038 863842 865068 865076 867636 868287 869093 871827 871790 863050 873698 873698 874387 874466 874728 876106 876624 876807 877651 813836 877789 877576 878774 878774 881729 881738 887762 887978 889727 891300 895873 895176 896768 895849 898137 897959 898145 898144 899398 898149 904691 891940 907",".","1500 units","The recall was initiated because Advanced Sterilization Products (ASP) has determined that the STERRAD 100NX and STERRAD 200 Sterilization Systems may emit an odor or smell into the surrounding environment that is not typical to normal operating conditions.",3/22/2013,"03/22/2013",4/10/2013,"04/10/2013"
"Devices",64693,"Ongoing","Toshiba American Medical Systems Inc","Tustin","CA","US","Voluntary: Firm Initiated","Letter","Nationwide Distribution.","Z-1104-2013","Class II","Aplio 500/400/300 Diagnostic Ultrasound System (TUS-500/400/300). Device Listing Number: Dl53118. Diagnostic Ultrasound system. ","Item numbers: TUS-A300/Wl and TUS-A500/Wl ",".","233 units","Toshiba Medical Systems has received reports of startup issues with the Toshiba TUS-500 and TUS-300 ultrasound systems. The startup issue is predominant when attempting to bring the system up from standby mode when the system is used remotely. It has been determined that this may potentially cause damage to the system.",12/11/2012,"12/11/2012",4/24/2013,"04/24/2013"
"Devices",64694,"Ongoing","GE Healthcare, LLC","Waukesha","WI","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution - US, including the states of AL, AZ, AR, CA, CO, CT, DE, DC, FL, IL, IN, IA, KY, LA, ME, MD, MA, MI, ,N,MS, MO, NE, NV, NH, NJ, NM, NY,NC, OH, OK,OR, PA, RI, SC, TN, TX, UT, VA, WA, WV, WI and the countries of TAIWAN, TURKEY, SINGAPORE, SWD EN, PORTUGAL, POLAND, NEW ZEALAND, NORWAY, NETHERLANDS, MALAYSIA, MEXICO, SOUTH KOREA, JAPAN, ITALY, INDIA, ISRAEL GREAT BRITAIN, FRANCE, DENMARK, GERMANY, SWITZERLAND, CANADA, BRAZIL BELGIUM, AUSTRALIA, and ARGENTINA.","Z-1168-2013","Class II","Ventri Discovery NM 530c, Ventri with Premium Table Discovery NM 530c, models H3000ZW & H3000SA. The system is used to perform nuclear imaging procedures.","Serial # 19069 19082 19065 19015 19057 19008 19005 19075 19064 19066 19078 19034 19061 19041 19081 19036 19058 16006 19151 19091 16013 19049 19073 19059 19016 0000000ME11041 19027 19062 19012 19030 16001 19097 19072 19035 19043 16014 19032 19020 19022 16004 16009 19053 16008 19093 19004 19029 19076 19050 16002 19019 19006 19038 16005 00000000VEN002 11021 0000000 VEN005 11039 11019 11001 11027 11008 11031 11028 11046 11038 11015 11045 11044 11043 11025 11018 11030 11033 11022 11026 11002 11003 11029 11032 11009 11020 11007 00000000VEN003 11010 11037 11013 11005 11041 11040 11006 00000000VEN004 11138 11220 11093 11294 11801 11228 11251 11253 11248 11209 11247 11193 11262 11214 11261 11054 11189 11092 11244 11260 11087 11255 11359 11231 11059 11237 11303 11212 11300 11417 11397 11391 11389 11232 11263 11210 11213 11208 11023 11290 11215 11091 11252 11245 11072 11219 11394 11205 11202 11225 11049 11131 11156 11242 11292 11243 11291 11102 11108 11298 11319 11250 11254 11384 11258 11257 11035 11114 000E3GT08064A6 0000E3GT09163A 0000E3GT08038A 0000INDNVC0041 0000E3GT10189A 0000E3GT09136A 11075 11430 11137 11154 11233 11052 11322 11301 11286 11078 11327 11125 11152 11387 11337 11396 11288 11147 11395 11427 11328 11450 11128 11471 11165 11424 11448 11421 11332 11203 11468 11363 11069 11127 11284 11124 11229 11297 11190 11204 11306 11061 11161 11151 11441 11067 11336 11435 11077 11191 11497 11206 11192 11211 11085 11325 11222 11392 11169 11347 11166 11050 11470 11464 11280 11469 11376 11310 11119 11501 11076 11086 11140 11366 11178 11495 11383 11352 11345 11358 11223 11183 11422 11004 11307 11107 11074 11293 11276 11270 11218 11142 11145 11060 11170 11188 11431 11088 11275 11462 11465 11117 11179 11414 11150 11149 11455 11089 11374 11056 11453 11017",".","556","GE Healthcare has recently become aware of an incident which caused a patient injury during an unload following an exam on a Ventri scanner. During a patient unload following a scan, the patients fingers may be pinched between the moving cradle edge and the stationary base of the table while the table is moving outward automatically.",1/9/2013,"01/09/2013",5/1/2013,"05/01/2013"
"Drugs",64695,"Ongoing","Gsms","Camarillo","CA","US","Voluntary: Firm Initiated","Letter","Nationwide","D-244-2013","Class II","LISINOPRIL AND HYDROCHLOROTHIAZIDE TABLETS, USP, 20 mg/25 mg, 100 (NDC 60429-046-01) and 1,000 (NDC 60429-046-10) count bottles, Rx only, GSMS Inc., Camarillo, CA"," Exp NDC Lot # Date 60429-046-10 69393A1 09/2015 60429-046-1 0 69395A1 09/2015 60429-046-10 69495A1 10/2015 60429-046-10 69496A1 10/2015 60429-046-01 69497A1 02/2014 60429-046-10 69524A1 10/2015 60429-046-10 69524A2 10/2015 60429-046-10 69525A1 10/2015 60429-046-10 69525A2 10/2015 ",,"6158 bottles","Presence of Foreign Substance: Reports of gray smudges identified as minute stainless steel particulates were found in the recalled tablets by the manufacturer",3/11/2013,"03/11/2013",4/17/2013,"04/17/2013"
"Devices",64696,"Ongoing","Baxter Healthcare Corp.","Deerfield","IL","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution - USA Nationwide and the countries of Puerto Rico, Brazil, Canada and Columbia.","Z-1269-2013","Class II","A) Product Code 2N3371: Non-DEHP Y-Type Catheter Extension Set, 5.7'', Vol. 0.8 mL, 2 Injection Sites, Male Luer Lock Adapter, Single use only Product Usage: This device is indicated for use in blood sampling and the administration of solutions. The InterLink Injection Site feature is intended to eliminate accidental needle sticks when used in conjunction with an InterLink Cannula as part of an I.V. needless access system.","A) Product Code 2N3371: Lots R12H23076, R12H30097, R12I0707, R12I08059, R12I25046, R12I2607, R12J11052, R12J12068, R12J13058R12K17057, R12L10084, R13A12057 ",".","A) Product Code 2N3371: 228,200 units","Customers have reported that when separating an individual package from its attached grouping, the adjacent package has opened, compromising its sterile barrier properties.",3/28/2013,"03/28/2013",5/15/2013,"05/15/2013"
"Devices",64696,"Ongoing","Baxter Healthcare Corp.","Deerfield","IL","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution - USA Nationwide and the countries of Puerto Rico, Brazil, Canada and Columbia.","Z-1271-2013","Class II","A) Product Code 2N8371: Non-DEHP Y-Type Catheter Extension Set Kit, 6.0'', Vol. 1.0 mL, 2 Luer Activated Valves, Male Luer Lock Adapter, Single use only Product Usage: The IV extension tubing kits are intended to provide users with a ready to use set up for the administration and withdrawal of fluids avoiding the need to acquire/assemble components from various manufacturers. The IV extension tubing sets are indicated for use with a vascular access device for administration and withdrawal of fluids. ","A) Product Code 2N8371: Lots R12E03108, R12H27085, R12H28075, R12H29057, R12H30139, R12103092, R12104058, R12105022, R12106061, R12110113, R12119056, R12120112, R12121151, R12122050, R12124106, R12124130, R12J25045, R12K03057, R12K19046, R12K21034, R12K21083, R12L05118, R12L08054, R12L18111, R12Ll9101, R13A08063, R13A08147, Rl3A09137, R13A10101, R13A14129, R13A15050 ",".","A) Product Code 2N8371: 513,000 units","Customers have reported that when separating an individual package from its attached grouping, the adjacent package has opened, compromising its sterile barrier properties.",3/28/2013,"03/28/2013",5/15/2013,"05/15/2013"
"Devices",64696,"Ongoing","Baxter Healthcare Corp.","Deerfield","IL","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution - USA Nationwide and the countries of Puerto Rico, Brazil, Canada and Columbia.","Z-1270-2013","Class II","A) Product Code 2N8220: Non-DEHP Catheter Extension Set Kit, Single use only, includes: 1) 7.7'', Vol. 1.10 mL, Luer Activated Valve for IV Access, Male Luer Lock Adapter, 2) Medium Catheter Stabilization Device, and 3) Foam Tape Strips; B) Product Code 2N8221: Non-DEHP Catheter Extension Set Kit, Single use only, includes: 1) 7.1'', Vol. 0.85 mL, Injection Site Male Luer Lock Adapter with Retractable Collar, 2) Medium Catheter Stabilization Device, and 3) Foam Tape Strips; C) Product Code 2N8222: Non-DEHP Catheter Extension Set Kit, Single use only, includes: 1) 8.2'', Vol. 0.57 mL, Luer Activated Valve for IV Access, Male Luer Lock Adapter, 2) Medium Catheter Stabilization Device, and 3) Foam Tape Strips; D) Product Code 2N8223: Non-DEHP Catheter Extension Set Kit, Single use only, includes: 1) 7.7'', Vol. 0.40 mL, Injection Site Male Luer Lock Adapter, 2) Medium Catheter Stabilization Device, and 3) Foam Tape Strips; E) Product Code 6N8220: V-LINK Luer Activated Device with VITALSHIELD Protective Coating Non-DEHP Catheter Extension Set Kit, Single use only, includes: 1) 7.6'', Vol. 1.0 mL, Catheter Extension Set, Luer Activated Device with Silver for IV Access, Male Luer Lock Adapter with Retractable Collar, 2) Medium Catheter Stabilization Device, and 3) Foam Tape Strips; F) Product Code 6N8222: V-LINK Luer Activated Device with VITALSHIELD Protective Coating Non-DEHP Catheter Extension Set Kit, Single use only, includes: 1) 8.2'', Vol. 0.5 mL, Catheter Extension Set, Luer Activated Device with Silver for IV Access, Male Luer Lock Adapter, 2) Medium Catheter Stabilization Device, and 3) Foam Tape Strips Product Usage: The IV extension tubing kits are intended to provide users with a ready to use set up for the administration and withdrawal of fluids avoiding the need to acquire/assemble components from various manufacturers. The IV extension tubing sets are indicated for use with a vascular access device for administration and withdrawal of fluids. ","A) Product Code 2N8220: Lots R12J05070; B) Product Code 2N8221: Lots R12J20046, R12J22042; C) Product Code 2N8222: Lots R12L07031; D) Product Code 2N8223: Lots R12L06074, R12K02083; E) Product Code 6N8220: Lots R12I01054, R12H25048, R12H27192, R12J04057, R12J22109, R12L07049, R12L08088; F) Product Code 6N8222: Lots R12J15046, R12J23115",".","A) Code 2N8220: 5,950; B) Code 2N8221: 6,150; C) Code 2N8222: 1,850; D) Code 2N8223: 7,900; E) Code 6N8220: 52,200; F) Code 6N8222: 1,200","Customers have reported that when separating an individual package from its attached grouping, the adjacent package has opened, compromising its sterile barrier properties.",3/28/2013,"03/28/2013",5/15/2013,"05/15/2013"
"Devices",64696,"Ongoing","Baxter Healthcare Corp.","Deerfield","IL","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution - USA Nationwide and the countries of Puerto Rico, Brazil, Canada and Columbia.","Z-1268-2013","Class II","A) Product Code 2N1191: Non-DEHP Y-Type Catheter Extension Set, 4.8'', Vol. 0.6 mL, Male Luer Lock Adapter, Single use only; B) Product Code 2N1206: Non-DEHP I.V. Catheter Extension Set, 5.7'', Vol. 0.7 mL, Male Luer Lock Adapter with Retractable Collar, Single use only Product Usage: These devices are indicated for use with a vascular access device for administration and withdrawal of fluids. ","A) Product Code 2N1191: Lots R12J06052, R12J08041, R12K06134, R12K08015, R12K26108, R12K27155; B) Product Code 2N1206: Lots R12J08124, R12J24121, R12K01119, R12K23089, R12K24053, R12K22016 ",".","A) Product Code 2N1191: 53,850; B) Product Code 2N1206: 101,900 units","Customers have reported that when separating an individual package from its attached grouping, the adjacent package has opened, compromising its sterile barrier properties.",3/28/2013,"03/28/2013",5/15/2013,"05/15/2013"
"Food",64697,"Ongoing","Lisy Corp.","Miami","FL","US","Voluntary: Firm Initiated","Letter","FL, GA, NJ, AL, PA, CA, NC, VA, MD, SC, RI, and OK","F-1406-2013","Class I","Adobo sin pimienta (Adobo without pepper) in 5 oz, 14 oz, and 32 oz","No code dates. Firm recalling all product purchased between 3/1/2011 to 3/27/2013",,,"Undeclared allergen - Soy",3/26/2013,"03/26/2013",5/22/2013,"05/22/2013"
"Food",64697,"Ongoing","Lisy Corp.","Miami","FL","US","Voluntary: Firm Initiated","Letter","FL, GA, NJ, AL, PA, CA, NC, VA, MD, SC, RI, and OK","F-1410-2013","Class I","Sazon Fajita (Fajita Seasoning) in 5 oz, 14 oz, and 28 oz","No code dates. Firm recalling all product purchased between 3/1/2011 to 3/27/2013",,,"Undeclared allergen - Soy",3/26/2013,"03/26/2013",5/22/2013,"05/22/2013"
"Food",64697,"Ongoing","Lisy Corp.","Miami","FL","US","Voluntary: Firm Initiated","Letter","FL, GA, NJ, AL, PA, CA, NC, VA, MD, SC, RI, and OK","F-1408-2013","Class I","Sazonador de Carnes (Meat Seasoning) in 5 oz, 14 oz, and 28 oz","No code dates. Firm recalling all product purchased between 3/1/2011 to 3/27/2013",,,"Undeclared allergen - Soy",3/26/2013,"03/26/2013",5/22/2013,"05/22/2013"
"Food",64697,"Ongoing","Lisy Corp.","Miami","FL","US","Voluntary: Firm Initiated","Letter","FL, GA, NJ, AL, PA, CA, NC, VA, MD, SC, RI, and OK","F-1409-2013","Class I","Sazon Perfecta (Perfect Seasoning) in 4 oz, 12 oz, and 24 oz","No code dates. Firm recalling all product purchased between 3/1/2011 to 3/27/2013",,,"Undeclared allergen - Soy",3/26/2013,"03/26/2013",5/22/2013,"05/22/2013"
"Food",64697,"Ongoing","Lisy Corp.","Miami","FL","US","Voluntary: Firm Initiated","Letter","FL, GA, NJ, AL, PA, CA, NC, VA, MD, SC, RI, and OK","F-1407-2013","Class I","Adobo con pimienta (Adobo with pepper) in 5 oz, 14 oz, and 32 oz","No code dates. Firm recalling all product purchased between 3/1/2011 to 3/27/2013",,,"Undeclared allergen - Soy",3/26/2013,"03/26/2013",5/22/2013,"05/22/2013"
"Devices",64698,"Ongoing","Sr Instruments Inc","Tonawanda","NY","US","Voluntary: Firm Initiated","Letter","USA Distribution in the state of Texas.","Z-1128-2013","Class II","SR Instruments FG3105 Patient Scales Used on various Joerns Healthcare Patient Lifters. Model# FG3105 Patient Scales. Product Usage: The FG3105 Scale is designed for Joerns Healthcare for use in portable patient weighing systems. The scale is designed to be connected between the patient hoist mechanism and patient sling apparatus. The scale is not intended to be used for patient transport. ","Serial numbers: 1005 thru 1780, 1785 thru 1809, 1866 thru 1868 and 1870 thru 1875. ",".","806 patient scales","SR Instruments Inc. is implementing a field correction for the Joerns Healthcare Patient Lifts after they received two incident reports regarding two field failures of a tensile type load cell involving the FG3105 Patient Scale. The failures resulted in patient falls.",12/13/2012,"12/13/2012",4/24/2013,"04/24/2013"
"Devices",64699,"Ongoing","Siemens Healthcare Diagnostics, Inc. ","West Sacramento","CA","US","Voluntary: Firm Initiated","Letter","US Nationwide Distribution including Puerto Rico.","Z-1272-2013","Class II","Siemens Healthcare Diagnostics Inc. MIcroScan MICroSTREP plus Type 1 B1027-201 panels. .MICroSTREP panels are designed for use in determining antimicrobial agent susceptibility of aerobic nonenterococcal streptococci (including Streptococcus pneumoniae) and Haemophilus spp.","All lots within expiration: Lot numbers: 2013-02-24 2013-03-05 2013-03-06 2013-04-03 2013-04-04 2013-04-19 2013-05-01 2013-05-10 2013-05-18 2013-05-21 2013-06-07 2013-06-18 2013-06-25 2013-07-27 2013-08-10 2013-08-23 2013-09-11 2013-09-14 2013-09-28 2013-10-02 2013-11-01 2013-11-02 2013-11-15 2013-11-29 2013-12-07 2013-12-12 2013-12-17 2014-01-04 2014-01-09 2014-01-15 2014-02-01 2014-02-13. ",".","21,608 boxes = 432,160 panels","Customer complaint investigation confirmed the issue of false skipped wells and false susceptible misreads with A. agalactiae affecting multiple antimicrobial agents on MicroScan Microbiology Systems.",3/6/2013,"03/06/2013",5/15/2013,"05/15/2013"
"Devices",64700,"Ongoing","Advanced Sterilization Products","Irvine","CA","US","Voluntary: Firm Initiated","Letter","Nationwide Distribution-USA including DC and the states of AL, AR, AZ, CA, CO, CT, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, ME, MD, MI, MN, MO, MS, NC, ND, NE, NH, NJ, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, WA, and WI.","Z-1123-2013","Class II","EVOTECH Endoscope Cleaner & Reprocessor System, P/N 50004 Designed to automatically clean and high-level disinfect flexible, submersible video or fiber-optic endoscopes.","Serial Numbers: 5041110197 5041110198 5041110205 5041110200 5041110206 5041110203 5041110207 5041110208 5041110211 5041110210 5041110216 5041110209 5041110225 5041110220 5041110218 5041110227 5041110219 5041110229 5041110212 5041110215 5041110223 5041110224 5041110221 5041110214 5041110226 5041120061 5041120065 5041120057 5041120064 5041120059 5041120069 5041120063 5041120072 5041120074 5041120066 5041120068 5041120070 5041120073 5041120076 5041120078 5041120079 5041120075 5041120077 5041120080 5041120084 5041120092 5041120096 5041120094 5041120071 5041120086 5041120089 5041120090 5041120088 5041120093 5041120095 5041120098 5041120103 5041120101 5041120091 5041120097 5041120104 5041120062 5041120105 5041120099 5041120085 5041120102 5041120108 5041120060 5041120107 5041120100 5041120106 5041120087 5041120116 5041120114 5041120113 5041120112 5041120111 5041120081 5041120067 5041120109 5041120118 5041120123 5041120110 5041120119 5041120125 5041120126 5041120117 5041120129 5041120132 5041120115 5041120127 5041120131 5041120121 5041120122 5041120130 5041120124 5041120133 5041120139 5041120136 5041120140 5041120137 5041120138 5041120157 5041120158 5041120159 5041120160 5041120161 5041120162 5041120163 5041120164 5041120165 5041120148 5041120149 5041120152 5041120153 5041120154 5041120155 5041120151 5041120150 5041120120 5041120169 5041120168 5041120176 5041120172 5041120141 5041120156 5041120142 5041120147 5041120146 5041120171 5041120145 5041120175 5041120181 5041120170 5041120173 5041120177 5041120183 5041120180 5041120182 5041120197 5041120179 5041120178 5041120190 5041120193 5041120184 5041120191 5041120196 5041120199 5041120192 5041120201 5041120203 5041120200 5041120194 5041120174 5041120198 5041120195 5041120185 5041120213 5041120206 5041120214 5041120208 5041120209 ",".","273 units","Advanced Sterilization Products (ASP) has determined that a limited number of EVOTECH ECRs manufactured between 2011 and 2012 did not receive sufficient High Potential (HIPOT) DC voltage testing.",3/22/2013,"03/22/2013",4/24/2013,"04/24/2013"
"Devices",64701,"Ongoing","Alere San Diego, Inc.","San Diego","CA","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","USA Nationawide Distribution","Z-1178-2013","Class II","The Alere Cholestech LDX high sensitivity C-Reactive Protein (hs-CRP) Test Cassette, Model Number 12-807. Product Usage: Immunoassay for the determination of C-Reactive Protein (CRP). The Alere Cholestech LDX high sensitivity C-Reactive Protein (hs-CRP) is an in vitro diagnostic test for the quantitative determination of C-reactive protein in whole blood or serum.","Model Number 12-807. Lot/Unit Codes: 274632, 281847 Expiration date, or Expected shelf life: 5/5/13, 6/30/13",".","2333 kits","The Alere Cholestech LDX hsCRP cassette (PN 12807) may have increased imprecision relative to the performance data in the package insert, which may cause differences in quantitative results for hsCRP compared to a reference method or repeat testing on the same patient sample.",3/6/2013,"03/06/2013",5/1/2013,"05/01/2013"
"Food",64702,"Ongoing","Heartland Gourmet, LLC","Lincoln","NE","US","Voluntary: Firm Initiated","E-Mail","The firm distributes their products to schools for fund raising events and also has internet distribution and some limited retail distribution. At this time we have records indicating distribution was made to TX, MN and CO. Distribution has been made to Canada.","F-1384-2013","Class I","Heartland Gourmet Gluten Free double chocolate cookie mix, DAIRY FREE, packaged in 16-oz. boxes. Manufactured by: Heartland Gourmet, LLC, Lincoln, NE.","Lots 0022317 best buy date 10/2014, 012341 best buy date 01/2014, and 0012289 best buy date 10/2014",,"4436/16-oz. boxes","Some of the products contain milk but are labeled as dairy free.",3/20/2013,"03/20/2013",5/22/2013,"05/22/2013"
"Food",64702,"Ongoing","Heartland Gourmet, LLC","Lincoln","NE","US","Voluntary: Firm Initiated","E-Mail","The firm distributes their products to schools for fund raising events and also has internet distribution and some limited retail distribution. At this time we have records indicating distribution was made to TX, MN and CO. Distribution has been made to Canada.","F-1385-2013","Class I","Heartland Gourmet Gluten Free chocolate chip cookie mix, DAIRY FREE, packaged in 16-oz. boxes. Manufactured by: Heartland Gourmet, LLC, Lincoln, NE.","Lot 023065, best buy date 12/2014 and Lot 0023007, best buy date 10/2014.",,"1555/16-oz boxes","Some of the products contain milk but are labeled as dairy free.",3/20/2013,"03/20/2013",5/22/2013,"05/22/2013"
"Food",64702,"Ongoing","Heartland Gourmet, LLC","Lincoln","NE","US","Voluntary: Firm Initiated","E-Mail","The firm distributes their products to schools for fund raising events and also has internet distribution and some limited retail distribution. At this time we have records indicating distribution was made to TX, MN and CO. Distribution has been made to Canada.","F-1386-2013","Class I","Heartland Gourmet Gluten Free rosemary basil pizza crust mix, DAIRY FREE, packaged in 15.4-oz. boxes. Manufactured by: Heartland Gourmet, LLC, Lincoln, NE.","Lot 073007 best buy date 09/2014",,"204/15.4-oz boxes","Some of the products contain milk but are labeled as dairy free.",3/20/2013,"03/20/2013",5/22/2013,"05/22/2013"
"Food",64703,"Ongoing","Gold Standard Baking, Inc.","Chicago","IL","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","IL","F-1285-2013","Class I","Sweet P's Bake Shop branded Caramel Apple Danish Coffee Cake, 14 oz, in a plastic clamshell package, UPC Code: 011225113833"," Lots: 020313 and 030613",".","1,134 cases (13,608 individual coffee cakes)","Sweet P's Bake Shop branded Caramel Apple Danish Coffee Cake contains undeclared walnuts. ",3/21/2013,"03/21/2013",4/10/2013,"04/10/2013"
"Devices",64704,"Ongoing","LeMaitre Vascular, Inc.","Burlington","MA","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution-USA (nationwide) and the countries of Canada, EU, and Asia.","Z-1055-2013","Class II","Glow 'N Tell 20 cm Tape: 1100-00 (100 strips); 1100-50 (50 strips); 1100-20 (20 strips). Intended to be placed on the skin to assist during imaging procedures.","SGL1190, exp 2017-02; SGL1196, exp 2017-09; SGL1197, exp. 2017-09",".","13560","Devices were not sealed correctly during the manufacturing process, and the sterility of these products have been compromised. ",3/18/2013,"03/18/2013",4/10/2013,"04/10/2013"
"Devices",64704,"Ongoing","LeMaitre Vascular, Inc.","Burlington","MA","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution-USA (nationwide) and the countries of Canada, EU, and Asia.","Z-1054-2013","Class II","LeMaitre Stent Guide: 1102-00 (100 strips); 1102-50 (50 strips); 1102-20 (20 strips). Intended to be placed on the skin to assist during imaging procedures.","LSG1130, exp. 2017-04; LSG1132, exp. 2017-11",".","6970","Devices were not sealed correctly during the manufacturing process, and the sterility of these products have been compromised. ",3/18/2013,"03/18/2013",4/10/2013,"04/10/2013"
"Devices",64705,"Ongoing","Smiths Medical ASD, Inc.","Keene","NH","US","Voluntary: Firm Initiated","Letter","Worldwide distribution: USA (Nationwide) and countries of: Arab Emirates (AE) Ireland (IE), Albania, Israel (IL), Argentina (AR),Italy (IT) Armenia (AM) , Japan (JP), Austria (AT) Jordan (JO), Bahrain (BH) Kuwait (KW) Belgium (BE), Lebanon (LB), Belarus , Netherlands (NL), Brazil (BR),Nigeria (NG), Bulgaria (BG) , Pakistan (PK), Canada (CA) Poland (PL), China (CN) Romania (RO), Columbia (CO), Russia (RU), Cyprus(CY) , Saudi Arabia (SA) Czech (CZ) , Singapore (SG), Denmark (OK), South Korea (KR), Egypt (EG), Spain (ES), Finland (FI), Sri Lanka (LK),Germany (DE) Turkey (TR) Ghana (GH) , Uganda (UG), Great Britain (GB) Ukraine (UA), Greece (GR) Uruguay (UY), and Hong Kong (HK).","Z-1243-2013","Class II","Wallace Sure-Pro Two Stage Embryo Replacement Catheter for difficult transfer with Stylet PPS623 Sure-Pro Embryo Replacement Catheters are used for the introduction of embryos into the uterine cavity following in vitro fertilization. Sure-Pro Ultra Embryo Replacement Catheters have the added benefit of being visible under ultrasound. These products can be used in either a one- stage or two-stage procedure. In the one-stage procedure, the clinician pushes the inner catheter through the outer sheath and loads the embryo prior to performing the embryo transfer into the uterus. In the two-stage procedure, the clinician places the outer sheath through the cervical canal into the uterus, then loads the embryo in the inner catheter, and advances the inner catheter through the outer sheath to perform the embryo transfer into the uterus.","Lot Code: 2000103, 2025752, 2161556, 2165854, 2170929, 2304190, 2363603",".","4910 units","Unable to pass catheter through outer sheath during embryo transfer",3/28/2013,"03/28/2013",5/15/2013,"05/15/2013"
"Devices",64705,"Ongoing","Smiths Medical ASD, Inc.","Keene","NH","US","Voluntary: Firm Initiated","Letter","Worldwide distribution: USA (Nationwide) and countries of: Arab Emirates (AE) Ireland (IE), Albania, Israel (IL), Argentina (AR),Italy (IT) Armenia (AM) , Japan (JP), Austria (AT) Jordan (JO), Bahrain (BH) Kuwait (KW) Belgium (BE), Lebanon (LB), Belarus , Netherlands (NL), Brazil (BR),Nigeria (NG), Bulgaria (BG) , Pakistan (PK), Canada (CA) Poland (PL), China (CN) Romania (RO), Columbia (CO), Russia (RU), Cyprus(CY) , Saudi Arabia (SA) Czech (CZ) , Singapore (SG), Denmark (OK), South Korea (KR), Egypt (EG), Spain (ES), Finland (FI), Sri Lanka (LK),Germany (DE) Turkey (TR) Ghana (GH) , Uganda (UG), Great Britain (GB) Ukraine (UA), Greece (GR) Uruguay (UY), and Hong Kong (HK).","Z-1240-2013","Class II","Wallace Sure-Pro Ultra Embryo Replacement Catheter with Obturator Product Code: PEB623 Sure-Pro Embryo Replacement Catheters are used for the introduction of embryos into the uterine cavity following in vitro fertilization. Sure-Pro Ultra Embryo Replacement Catheters have the added benefit of being visible under ultrasound. These products can be used in either a one- stage or two-stage procedure. In the one-stage procedure, the clinician pushes the inner catheter through the outer sheath and loads the embryo prior to performing the embryo transfer into the uterus. In the two-stage procedure, the clinician places the outer sheath through the cervical canal into the uterus, then loads the embryo in the inner catheter, and advances the inner catheter through the outer sheath to perform the embryo transfer into the uterus.","Lot Codes: 2000101 2044006 2044008 2044009 2065654 2117203 2117204 2120950 2138835 2152580 2152582 2156663 2165851 2165852 2170920 2170926 2295309 2304187 2304192 2304193 2304194 2304196 2304197 2304198 2305241 2305243 2313279 2324539 2327973 2327974 2336959 2341411 2341412 2341414 2341415 2341416 2341420 ",".","59089 units","Unable to pass catheter through outer sheath during embryo transfer",3/28/2013,"03/28/2013",5/15/2013,"05/15/2013"
"Devices",64705,"Ongoing","Smiths Medical ASD, Inc.","Keene","NH","US","Voluntary: Firm Initiated","Letter","Worldwide distribution: USA (Nationwide) and countries of: Arab Emirates (AE) Ireland (IE), Albania, Israel (IL), Argentina (AR),Italy (IT) Armenia (AM) , Japan (JP), Austria (AT) Jordan (JO), Bahrain (BH) Kuwait (KW) Belgium (BE), Lebanon (LB), Belarus , Netherlands (NL), Brazil (BR),Nigeria (NG), Bulgaria (BG) , Pakistan (PK), Canada (CA) Poland (PL), China (CN) Romania (RO), Columbia (CO), Russia (RU), Cyprus(CY) , Saudi Arabia (SA) Czech (CZ) , Singapore (SG), Denmark (OK), South Korea (KR), Egypt (EG), Spain (ES), Finland (FI), Sri Lanka (LK),Germany (DE) Turkey (TR) Ghana (GH) , Uganda (UG), Great Britain (GB) Ukraine (UA), Greece (GR) Uruguay (UY), and Hong Kong (HK).","Z-1244-2013","Class II","Wallace Sure-Pro Single Stage Embryo Replacement Catheter Product Code: PP623 Sure-Pro Embryo Replacement Catheters are used for the introduction of embryos into the uterine cavity following in vitro fertilization. Sure-Pro Ultra Embryo Replacement Catheters have the added benefit of being visible under ultrasound. These products can be used in either a one- stage or two-stage procedure. In the one-stage procedure, the clinician pushes the inner catheter through the outer sheath and loads the embryo prior to performing the embryo transfer into the uterus. In the two-stage procedure, the clinician places the outer sheath through the cervical canal into the uterus, then loads the embryo in the inner catheter, and advances the inner catheter through the outer sheath to perform the embryo transfer into the uterus.","Lot codes: 2000098 2025748 2041152 2332539 2350024 ",".","800 units","Unable to pass catheter through outer sheath during embryo transfer",3/28/2013,"03/28/2013",5/15/2013,"05/15/2013"
"Devices",64705,"Ongoing","Smiths Medical ASD, Inc.","Keene","NH","US","Voluntary: Firm Initiated","Letter","Worldwide distribution: USA (Nationwide) and countries of: Arab Emirates (AE) Ireland (IE), Albania, Israel (IL), Argentina (AR),Italy (IT) Armenia (AM) , Japan (JP), Austria (AT) Jordan (JO), Bahrain (BH) Kuwait (KW) Belgium (BE), Lebanon (LB), Belarus , Netherlands (NL), Brazil (BR),Nigeria (NG), Bulgaria (BG) , Pakistan (PK), Canada (CA) Poland (PL), China (CN) Romania (RO), Columbia (CO), Russia (RU), Cyprus(CY) , Saudi Arabia (SA) Czech (CZ) , Singapore (SG), Denmark (OK), South Korea (KR), Egypt (EG), Spain (ES), Finland (FI), Sri Lanka (LK),Germany (DE) Turkey (TR) Ghana (GH) , Uganda (UG), Great Britain (GB) Ukraine (UA), Greece (GR) Uruguay (UY), and Hong Kong (HK).","Z-1241-2013","Class II","Wallace Sure-Pro Ultra Embryo Replacement Catheter with Stylet Product Code:PES623 Sure-Pro Embryo Replacement Catheters are used for the introduction of embryos into the uterine cavity following in vitro fertilization. Sure-Pro Ultra Embryo Replacement Catheters have the added benefit of being visible under ultrasound. These products can be used in either a one- stage or two-stage procedure. In the one-stage procedure, the clinician pushes the inner catheter through the outer sheath and loads the embryo prior to performing the embryo transfer into the uterus. In the two-stage procedure, the clinician places the outer sheath through the cervical canal into the uterus, then loads the embryo in the inner catheter, and advances the inner catheter through the outer sheath to perform the embryo transfer into the uterus."," Lot Codes: 2000102 2138834 2143444 2147484 2152583 2152584 2304183 2305244 2336960 ",".","11550 units","Unable to pass catheter through outer sheath during embryo transfer",3/28/2013,"03/28/2013",5/15/2013,"05/15/2013"
"Devices",64705,"Ongoing","Smiths Medical ASD, Inc.","Keene","NH","US","Voluntary: Firm Initiated","Letter","Worldwide distribution: USA (Nationwide) and countries of: Arab Emirates (AE) Ireland (IE), Albania, Israel (IL), Argentina (AR),Italy (IT) Armenia (AM) , Japan (JP), Austria (AT) Jordan (JO), Bahrain (BH) Kuwait (KW) Belgium (BE), Lebanon (LB), Belarus , Netherlands (NL), Brazil (BR),Nigeria (NG), Bulgaria (BG) , Pakistan (PK), Canada (CA) Poland (PL), China (CN) Romania (RO), Columbia (CO), Russia (RU), Cyprus(CY) , Saudi Arabia (SA) Czech (CZ) , Singapore (SG), Denmark (OK), South Korea (KR), Egypt (EG), Spain (ES), Finland (FI), Sri Lanka (LK),Germany (DE) Turkey (TR) Ghana (GH) , Uganda (UG), Great Britain (GB) Ukraine (UA), Greece (GR) Uruguay (UY), and Hong Kong (HK).","Z-1239-2013","Class II","Wallace Sure-Pro/ Sure-Pro Ultra Embryo Replacement Catheters (with ultrasound) Product Code: PE623 Sure-Pro Embryo Replacement Catheters are used for the introduction of embryos into the uterine cavity following in vitro fertilization. Sure-Pro Ultra Embryo Replacement Catheters have the added benefit of being visible under ultrasound. These products can be used in either a one- stage or two-stage procedure. In the one-stage procedure, the clinician pushes the inner catheter through the outer sheath and loads the embryo prior to performing the embryo transfer into the uterus. In the two-stage procedure, the clinician places the outer sheath through the cervical canal into the uterus, then loads the embryo in the inner catheter, and advances the inner catheter through the outer sheath to perform the embryo transfer into the uterus.","Lot Codes: 2000099 2044001 2044005 2117201 2117202 2120953 2138832 2138833 2161554 2304181 2304182 2304199 2305239 2305240 2308138 2313278 2332537 2336956 2336957 2341409 2341410 2344790 ",".","22380 units ","Unable to pass catheter through outer sheath during embryo transfer",3/28/2013,"03/28/2013",5/15/2013,"05/15/2013"
"Devices",64705,"Ongoing","Smiths Medical ASD, Inc.","Keene","NH","US","Voluntary: Firm Initiated","Letter","Worldwide distribution: USA (Nationwide) and countries of: Arab Emirates (AE) Ireland (IE), Albania, Israel (IL), Argentina (AR),Italy (IT) Armenia (AM) , Japan (JP), Austria (AT) Jordan (JO), Bahrain (BH) Kuwait (KW) Belgium (BE), Lebanon (LB), Belarus , Netherlands (NL), Brazil (BR),Nigeria (NG), Bulgaria (BG) , Pakistan (PK), Canada (CA) Poland (PL), China (CN) Romania (RO), Columbia (CO), Russia (RU), Cyprus(CY) , Saudi Arabia (SA) Czech (CZ) , Singapore (SG), Denmark (OK), South Korea (KR), Egypt (EG), Spain (ES), Finland (FI), Sri Lanka (LK),Germany (DE) Turkey (TR) Ghana (GH) , Uganda (UG), Great Britain (GB) Ukraine (UA), Greece (GR) Uruguay (UY), and Hong Kong (HK).","Z-1242-2013","Class II","Wallace Sure-Pro Two Stage Embryo Replacement Catheter with Obturator PPB623 Sure-Pro Embryo Replacement Catheters are used for the introduction of embryos into the uterine cavity following in vitro fertilization. Sure-Pro Ultra Embryo Replacement Catheters have the added benefit of being visible under ultrasound. These products can be used in either a one- stage or two-stage procedure. In the one-stage procedure, the clinician pushes the inner catheter through the outer sheath and loads the embryo prior to performing the embryo transfer into the uterus. In the two-stage procedure, the clinician places the outer sheath through the cervical canal into the uterus, then loads the embryo in the inner catheter, and advances the inner catheter through the outer sheath to perform the embryo transfer into the uterus.","Lot codes: 2000100 2025750 2044018 2044019 2065655 2120952 2152589 2152590 2156664 2156665 2170927 2295308 2305235 2305236 2305237 2305238 2308139 2308141 2313280 2313281 2320238 2324603 2336961 2341418 2359095 2363587 2363588 2363589 2363592 2363593 2363594 2363595 2363596 2363597 2363598 ",".","37620 units","Unable to pass catheter through outer sheath during embryo transfer",3/28/2013,"03/28/2013",5/15/2013,"05/15/2013"
"Devices",64706,"Ongoing","DePuy Mitek, Inc., a Johnson & Johnson Co.","Raynham","MA","US","Voluntary: Firm Initiated","Letter","Nationwide Distribution.","Z-1176-2013","Class II","ORTHOCORD One Violet and One Blue Braided Composite Suture with OS-6 Reverse Cutting Needles, Product Code: 223116. For use in general soft tissue approximation, and/or ligation, including orthopedic procedures.","ALL from Jan 1 2010 - Corrected IFU implementation date ",".","46501","The IFU provided with the free strand ORTHOCORD sutures currently indicates that approximately 100% suture strength remains at six weeks after implantation. While this statement is true for Violet ORTHOCORD sutures, it is an inaccurate statement for Blue ORTHOCORD free strand sutures. Based on in-vivo strength retention study, a Blue ORTHOCORD sutures maintain approximately 80% of strength at six weeks after implantation.",3/22/2013,"03/22/2013",5/1/2013,"05/01/2013"
"Devices",64706,"Ongoing","DePuy Mitek, Inc., a Johnson & Johnson Co.","Raynham","MA","US","Voluntary: Firm Initiated","Letter","Nationwide Distribution.","Z-1174-2013","Class II","ORTHOCORD One Violet and One Blue Braided Composite Suture with MO-7 Taper Needles, Catalog Number: 223114. For use in general soft tissue approximation, and/or ligation, including orthopedic procedures.","ALL from Jan 1 2010 - Corrected IFU implementation date ",".","206540","The IFU provided with the free strand ORTHOCORD sutures currently indicates that approximately 100% suture strength remains at six weeks after implantation. While this statement is true for Violet ORTHOCORD sutures, it is an inaccurate statement for Blue ORTHOCORD free strand sutures. Based on in-vivo strength retention study, a Blue ORTHOCORD sutures maintain approximately 80% of strength at six weeks after implantation.",3/22/2013,"03/22/2013",5/1/2013,"05/01/2013"
"Devices",64706,"Ongoing","DePuy Mitek, Inc., a Johnson & Johnson Co.","Raynham","MA","US","Voluntary: Firm Initiated","Letter","Nationwide Distribution.","Z-1172-2013","Class II","ORTHOCORD BLUE BRAIDED COMPOSITE SUTURE 2 (5 METRIC), Catalog Number: 223111. For use in general soft tissue approximation, and/or ligation, including orthopedic procedures.","ALL from Jan 1 2010 - Corrected IFU implementation date ",".","65062","The IFU provided with the free strand ORTHOCORD sutures currently indicates that approximately 100% suture strength remains at six weeks after implantation. While this statement is true for Violet ORTHOCORD sutures, it is an inaccurate statement for Blue ORTHOCORD free strand sutures. Based on in-vivo strength retention study, a Blue ORTHOCORD sutures maintain approximately 80% of strength at six weeks after implantation.",3/22/2013,"03/22/2013",5/1/2013,"05/01/2013"
"Devices",64706,"Ongoing","DePuy Mitek, Inc., a Johnson & Johnson Co.","Raynham","MA","US","Voluntary: Firm Initiated","Letter","Nationwide Distribution.","Z-1173-2013","Class II","ORTHOCORD ONE VIOLET AND ONE BLUE BRAIDED COMPOSITE SUTURE 2 (5 METRIC), Catalog Number: 223113. For use in general soft tissue approximation, and/or ligation, including orthopedic procedures.","ALL from Jan 1 2010 - Corrected IFU implementation date ",".","84174","The IFU provided with the free strand ORTHOCORD sutures currently indicates that approximately 100% suture strength remains at six weeks after implantation. While this statement is true for Violet ORTHOCORD sutures, it is an inaccurate statement for Blue ORTHOCORD free strand sutures. Based on in-vivo strength retention study, a Blue ORTHOCORD sutures maintain approximately 80% of strength at six weeks after implantation.",3/22/2013,"03/22/2013",5/1/2013,"05/01/2013"
"Devices",64706,"Ongoing","DePuy Mitek, Inc., a Johnson & Johnson Co.","Raynham","MA","US","Voluntary: Firm Initiated","Letter","Nationwide Distribution.","Z-1175-2013","Class II","ORTHOCORD One Violet and One Blue Braided Composite Suture with MO-6 Taper Needles, Product Code: 223115. For use in general soft tissue approximation, and/or ligation, including orthopedic procedures.","ALL from Jan 1 2010 - Corrected IFU implementation date ",".","46732","The IFU provided with the free strand ORTHOCORD sutures currently indicates that approximately 100% suture strength remains at six weeks after implantation. While this statement is true for Violet ORTHOCORD sutures, it is an inaccurate statement for Blue ORTHOCORD free strand sutures. Based on in-vivo strength retention study, a Blue ORTHOCORD sutures maintain approximately 80% of strength at six weeks after implantation.",3/22/2013,"03/22/2013",5/1/2013,"05/01/2013"
"Devices",64707,"Ongoing","Ortho-Clinical Diagnostics","Rochester","NY","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution-USA (nationwide) and Puerto Rico and the countries of Australia, Bermuda, Brazil, Canada, Chile, China, Colombia, England, France, Germany, India, Italy, Japan, Mexico, Republic of Panama, Singapore, Spain, and Venezuela.","Z-1152-2013","Class II","VITROS Chemistry Products PHBR (Phenobarbital) Slides, REF 822 1384. For the quantitative measure of phenobarbital (PHBR) concentration in serum and plasma. ","All Lot Numbers containing: GEN 38, Coating No. 0060, Expiration Date Range 03/01/13 through 07/01/13; GEN 39, Coating No. 0062, Expiration Date Range 07/01/13 through 09/01/13; GEN 40, Coating No. 0063, Expiration Date Range 10/01/13 through 12/01/13; GEN 41, Coating No. 0064, Expiration Date Range 12/01/13 through 02/01/14. [A Coating (CTG) is a unique identifier within the Lot Number of some of OCD's products. The term GEN and CTG refer to a specific segments of the reagent lot number. Current lots within expiry were all from Coatings 0060, 0062, 0063 or 0064.]. ",".","Domestic: 11,164 units, Foreign: 594 units","Ortho Clinical Diagnostics (OCD) received customer complaints of intermittent imprecision, outliers, or shifts in accuracy and control fluid values outside of expected intervals when using VITROS Chemistry Products PHBR Slides. OCD's investigation confirmed that positively biased values for patient samples could be obtained that may not be detected by quality control fluids.",3/14/2013,"03/14/2013",5/1/2013,"05/01/2013"
"Devices",64708,"Ongoing","Philips Healthcare Inc.","Andover","MA","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution including USA (nationwide)","Z-1003-2013","Class II","Philips Healthcare Computed Tomography X-Ray System. These devices are whole-body computed tomography (CT) x-ray systems or sub-systems, each with a continuously rotating x-ray tube and multi-row detectors enclosed by a gantry. X-ray transmission data acquired and taken at different angles can be reconstructed into cross-sectional images. Each device also includes signal analysis and display equipment, patient and equipment supports, components, and accessories.","Gemini Dual, Gemini 16 Power, Gemini GXL, Gemini LXL, Gemini TF 16, Gemini TF Base/Ready, Gemini TF 64, Gemini TF Big Bore, Precedence SPECT/CT, Brilliance CT (6, 10,16, 16P, 40, 64, and Big Bore), Brilliance iCT, Brilliance iCT SP",".","2089 US 4036 ROW","Philips Healthcare discovered the customer was performing CTDI measurements for facility accreditation and received results that were 15 to 25% higher than Philips protocol parameters stated.",4/5/2010,"04/05/2010",4/24/2013,"04/24/2013"
"Food",64709,"Ongoing","Meijer Distribution, Inc","Grand Rapids","MI","US","Voluntary: Firm Initiated","E-Mail","Meijer stores in IL, IN, MI, OH, KY","F-1273-2013","Class II","Meijer, Spiced Jelly Beans, 32 oz, Product of Mexico, UPC 8-86926-50931-1.","all lots",,"16,320 units","32 oz bags of Meijer Spiced Jelly Beans contain undeclared Yellow # 6.",3/20/2013,"03/20/2013",4/3/2013,"04/03/2013"
"Drugs",64710,"Ongoing","Noven Pharmaceuticals, Inc.","Miami","FL","US","Voluntary: Firm Initiated","Letter","Nationwide and Puerto Rico.","D-312-2013","Class II","Daytrana (methylphenidate) transdermal system patch, Delivers 10 mg over 9 hours (1.1 mg/hr), 1 patch per pouch, packaged in 30-count patches per box, Rx only, Manufactured for Noven Therapeutics, LLC, Miami, FL 33186, By Noven Pharmaceuticals, Inc., Miami, FL 33186; NDC 68968-5552-3. ","Lot #59824, Exp 04/13",,"335,910 patches","Defective Delivery System: Out of Specification (OOS) results for the z-statistic value, which relates to the patients and caregiver ability to remove the release liner from the patch adhesive prior to administration, were obtained.",1/31/2013,"01/31/2013",5/8/2013,"05/08/2013"
"Devices",64711,"Terminated","Remel Inc","Lenexa","KS","US","Voluntary: Firm Initiated","Letter","Nationwide distribution: AL, AR, CA, CO, CT, FL, GA, IA, IL, KS, MA, MD, MI, MO, NM, NV, NY, OH, PA, TX, WA, and WI.","Z-1962-2013","Class III","Remel X/pect Flu A&B Control Swabs, For In Vitro Diagnostic Use, Ref R246003, each package contains 20 Flu A Control Swabs and 20 Flu B Control Swabs, each swab is individually packaged in a foil pouch. The firm name on the label is Remel Europe, Ltd., Dartford, Kent, United Kingdom. Product is a test kit containing characterized positive and negative controls intended for use in qualitative procedures as external quality control material for the Remel Xpect Flu A&B test kit.","Lot 260745, exp. 5/31/2014",,"96 kits of 20 swab sets","Flu A+ Control Swabs incorrectly give Flu A- results when used for quality control testing with the Xpect Flu A&B test kit.",2/19/2013,"02/19/2013",8/21/2013,"08/21/2013"
"Devices",64712,"Ongoing","Accuray Incorporated","Sunnyvale","CA","US","Voluntary: Firm Initiated","Letter","Worldwide distribution, including Nationwide in the US and the countries of Korea, Myanmar, Canada, Belgium, England, Czech Republic, Finland, France, Germany, Greece, India, Italy, Poland, Russia, Spain, Switzerland, Turkey, Columbia, Mexico, Japan and Saudi Arabia.","Z-1126-2013","Class II","Accuray CyberKnife System Medical Physicist, Robotic Radiosurgery System, Medical charged-particle radiation therapy system, Model: Iris Variable Aperture Collimator P/Ns 028986 and 031777. The CyberKnife System is indicated for radiation treatment.","All units of these models.",".","176 units","A defect on the master-side connector block of the pneumatic tool changer could introduce a tilt in the collimator housings, resulting in a potential shift to the central axis of the radiation beam. The issue could pose significant clinical impact to plans created using the smallest collimators.",3/19/2013,"03/19/2013",4/24/2013,"04/24/2013"
"Devices",64713,"Ongoing","Philips Medical Systems (Cleveland) Inc","Cleveland","OH","US","Voluntary: Firm Initiated","Letter","Worldwide distribution: USA (nationwide) including states of: AL, AR, AZ, CA, CO, CT, DE, FL, GA, HI, IA, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, PR, RI, SC, TN, TX, VA, VT, WA, WI, WV and WY; countries of: Argentina, Australia, Austria, Belgium, Brazil, Canada, China, Colombia, Denmark, France, Germany, Gibraltar, India, Iraq, Ireland, Israel, Italy, Japan, Mexico, Netherlands, New Zealand, Nicaragua, Norway, Philippines, Poland, Portugal, Singapore, South Korea, Spain, Sweden, Switzerland, Thailand, Turkey, United Kingdom and Venezuela.","Z-1338-2013","Class II","Brilliance CT 16-Slice Water, System Code: 728245; Brilliance CT 10-Slice Water, System Code: 728250; Brilliance CT 6-Slice Water, System Code: 728255; MX8000 IDT 16, System Code: 728120 & MX8000 IDT 10, System Code: 728125 Computed Tomography X-ray systems. Distributed by Philips Medical Systems (Cleveland), Inc., 595 Miner Road, Cleveland, OH 44143 Computed Tomography X-ray systems intended to produce cross-sectional images of the body by computer reconstruction of X-ray transmission data taken at different angles and planes. This device may include signal analysis and display equipment, patient, and equipment supports, components and accessories.","System Code #728255, Serial #: 9702, 9703, 9704, 9705, 9706, 9707, 9709, 9710, 9713, 9714, 9717, 9718, 9719, 9721, 9722, 9723, 9724, 9725, 9727, 9730, 9731, 9732, 9733, 9734, 9735, 9738, 9739, 9740, 9741, 9742, 9743, 9746, 9747, 9749, 9752, 9753, 9756, 9758, 9759, 9760, 9761, 9762, 9765, 9766, 9768, 9769, 9770, 9772, 9774, 9778, 9780, 9781, 9783, 9784, 9786, 9787, 9790, 9791, 9792, 9793, 9796, 9797, 9801, 9805, 9807, 9808 & 9810. System Code #728250, Serial #: 2556, 2557, 2560, 2562, 2563, 2565, 2567, 2568, 2569, 2570, 2571, 2574, 2576, 2577, 2579, 2580, 2581, 2584, 2585, 2587, 2588, 2590, 2591, 2592, 2593, 2594, 2595, 2597, 9738 & 9741. System Code #728245, Serial #: 2562, 2564, 2567, 2573, 2576, 2582, 2584, 2585, 2586, 2587, 2589, 2590, 2594, 2596, 2597, 3014, 3091, 3105, 3151, 3217, 3235, 3287, 3303, 3312, 3339, 3340, 3341, 3342, 3343, 3344, 3346, 3348, 3351, 3353, 3355, 3356, 3357, 3358, 3359, 3360, 3363, 3364, 3366, 3369, 3371, 3373, 3374, 3377, 3378, 3379, 3380, 3381, 3382, 3383, 3385, 3388, 3392, 3393, 3394, 3397, 3400, 3404, 3406, 3407, 3408, 3410, 3413, 3414, 3415, 3416, 3419, 3423, 3425, 3427, 3429, 3431, 3432, 3433, 3435, 3436, 3437, 3438, 3439, 3440, 3441, 3443, 3445, 3446, 3448, 3449, 3451, 3452, 3453, 3454, 3455, 3458, 3459, 3461, 3462, 3464, 3468, 3469, 3470, 3471, 3473, 3474, 3475, 3477, 3478, 3479, 3481, 3482, 3483, 3484, 3485, 3486, 3488, 3489, 3491, 3492, 3493, 3495, 3496, 3497, 3498, 3499, 3500, 3501, 3502, 3503, 3504, 3505, 3508, 3509, 3510, 3511, 3512, 3513, 3514, 3515, 3517, 9716, 9718, 9719, 9724, 9732, 9741, 9743, 9746, 9749, 9778, 9780, 9787, 9790, 9797, 9801, 9808 & 9810. System Code #728120, Serial #: 2502, 2510, 2513, 2516, 2517, 2518, 2525, 2528, 2531, 2533, 2535, 2539, 2546, 3006, 3008, 3013, 3014, 3021, 3025, 3026, 3027, 3028, 3029, 3030, 3035, 3037, 3039, 3040, 3043, 3044, 3047, 3049, 3050, 3051, 3053, 3054, 3056, 3059, 3061, 3062, 3063, 3064, 3068, 3069, 3070, 3072, 3073, 3075, 3076, 3077, 3078, 3079, 3081, 3082, 3084, 3085, 3087, 3088, 3089, 3091, 3093, 3094, 30",".","515 units","Philips Healthcare received a report from the field stating when they viewed the CTDIVol information from the PACS system, the calculations were too high. Instead of storing the CTDIVol value for each slice in the DICOM tag, the system took the sum of all CTDIVol values from all the images in the dataset and stored this value in the DICOM tag, resulting in incorrect information.",3/12/2013,"03/12/2013",5/29/2013,"05/29/2013"
"Food",64714,"Ongoing","F.H.G Corporation dba Integrity Nutraceuticals","Spring Hill","TN","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","NC, MD, ID, FL, AR, PA, CA, CT, CO, IL, UT, NJ, IA, MS, Australia, Cook Islands","F-1298-2013","Class II","MUSCLEPHARM brand COMBAT POWDER (R), BANANA CREAM, NATURAL AND ARTIFICAL FLAVORS, HYBRID SERIES DIETARY SUPPLEMENT, NET WEIGHT 2 LBS (907 GRAMS), EXCLUSIVELY DEVELOPED AND MANUFACTURED FOR: MUSCLEPHARM(TM) CORP., 4721 Ironton St., Denver, CO, 80239, UPC 736211050571","Lot # 123732 027, Expiration date 02/2015",,"2427 units","One lot of each product may have extraneous materials due to a problem on the packing line.",3/14/2013,"03/14/2013",4/17/2013,"04/17/2013"
"Food",64714,"Ongoing","F.H.G Corporation dba Integrity Nutraceuticals","Spring Hill","TN","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","NC, MD, ID, FL, AR, PA, CA, CT, CO, IL, UT, NJ, IA, MS, Australia, Cook Islands","F-1297-2013","Class II","MUSCLEPHARM brand COMBAT POWDER (R), COOKIES 'N' CREAM, NATURAL AND ARTIFICAL FLAVORS, HYBRID SERIES DIETARY SUPPLEMENT, NET WEIGHT 2 LBS (907 GRAMS), EXCLUSIVELY DEVELOPED AND MANUFACTURED FOR: MUSCLEPHARM(TM) CORP., 4721 Ironton St., Denver, CO, 80239, UPC 736211050670","Lot # 123932 026, Expiration date 02/2015",,"2541 units","One lot of each product may have extraneous materials due to a problem on the packing line.",3/14/2013,"03/14/2013",4/17/2013,"04/17/2013"
"Devices",64715,"Ongoing","Teleflex Medical","Durham","NC","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution - USA and the countries of Singapore, Canada, New Zealand, Germany, Ireland, Japan and Australia.","Z-1158-2013","Class II","Belly Bag Urine Collection Bag with Hip Belt. The product is a sterile urine collection device that collects urine by mechanical means when attached to an indwelling Foley or suprapubic catheter.","CATALOG NO. B1000 - 02A1100488, 02A1100489, 02A1100490, 02A1100491, 02A1100492, 02A1101420, 02A1101421, 02A1102009, 02A1102010, 02A1102049, 02A1102050, 02A1103180, 02A1103181, 02A1103182, 02A1201862, 02A1201868, 02A1201869, 02A1201870, 02A1201871, 02A1202372, 02A1202373, 02A1202374, 02A1202376, 02A1202377, 02A1202378, 02A1202603, 02A1202632, 02A1202633, 02A1202634, 02A1202783, 02A1202784, 02A1202785, 02A1202786, 02A1202787, 02A1202788, 02A1202789, 02A1202790, 02A1202791, 02A1202792, 02A1203552, 02A1203553, 02A1203554, 02A1203555, 02A1203556, 02A1204179, 02B1100522, 02B1100523, 02B1100524, 02B1101000, 02B1101001, 02B1101002, 02B1102328, 02B1102329, 02B1103007, 02B1200105, 02B1200106, 02B1200107, 02B1201685, 02B1201686 02B1201687, 02B1201688, 02B1201689, 02B1202029, 02B1202508, 02B1202509, 02C1000808, 02C1000910, 02C1000911, 02C1000912, 02C1001699, 02C1001725, 02C1002642, 02C1002655, 02C1002656, 02C1002657, 02C1002990, 02C1003816, 02C1003817, 02C1003818, 02C1100328, 02C1100329, 02C1100330, 02C1100331, 02C1103877, 02D1000274, 02D1000982, 02D1000983, 02D1002061, 02D1002062, 02D1002063, 02D1002753, 02D1002754, 02D1002755, 02D1200734, 02D1200735, 02D1200736, 02D1200737, 02D1203071, 02D1203072, 02D1203073, 02D1203074, 02D1203075, 02D1203084, 02E1002077, 02E1002746, 02E1002747, 02E1102105, 02E1102106, 02E1102107, 02E1102346, 02E1102347, 02E1102348, 02E1102349, 02E1102350, 02E1103220, 02E1103221, 02E1103222, 02E1103223, 02E1103225, 02E1200137, 02E1200138, 02E1200139, 02E1200140, 02E1200141, 02E1200142, 02E1200143, 02E1200144, 02E1201212, 02E1201234, 02E1201235, 02E1201236, 02E1201237, 02E1201238, 02E1201811, 02E1201812, 02E1201813, 02E1201983, 02E1201984, 02E1201985, 02E1201986, 02E1201987, 02E1201988, 02E1201989, 02F1000379, 02F1000380, 02F1001044, 02F1001045, 02F1001046, 02F1001801, 02F1001802, 02F1002742, 02F1002743, 02F1002744, 02F1003780, 02F1003781, 02F1003782, 02F1101266, 02F1102102, 02F1102107, 02F1102108, 02F1103126, 02F1103127, 02F1103128, 02F1103129, 02F1103566, 02F1103567, 02F1103568, 02F1103569, 02F1201733",".","190,103","Sterile packaging may be compromised.",3/28/2013,"03/28/2013",5/1/2013,"05/01/2013"
"Drugs",64716,"Completed","Pallimed Solutions","Woburn","MA","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Nationwide","D-879-2013","Class II","Trimix Injection, compounded by Pallimed Solutions Pharmacy, Woburn, MA","All lots within expiry",,"862 vials","Lack of Assurance of Sterility; FDA inspectional findings resulted in concerns associated with quality control procedures that impacted sterility assurance",3/25/2013,"03/25/2013",8/21/2013,"08/21/2013"
"Drugs",64716,"Completed","Pallimed Solutions","Woburn","MA","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Nationwide","D-880-2013","Class II","Vancomycin Ophthalmic PF, compounded by Pallimed Solutions Pharmacy, Wobrun, MA","All lots within expiry",,"12 vials","Lack of Assurance of Sterility; FDA inspectional findings resulted in concerns associated with quality control procedures that impacted sterility assurance",3/25/2013,"03/25/2013",8/21/2013,"08/21/2013"
"Drugs",64716,"Completed","Pallimed Solutions","Woburn","MA","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Nationwide","D-865-2013","Class II","Diazepam Injectable, compounded by Pallimed Solutions Pharmacy, Woburn, MA","All lots within expiry",,"7 vials","Lack of Assurance of Sterility; FDA inspectional findings resulted in concerns associated with quality control procedures that impacted sterility assurance",3/25/2013,"03/25/2013",8/21/2013,"08/21/2013"
"Drugs",64716,"Completed","Pallimed Solutions","Woburn","MA","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Nationwide","D-866-2013","Class II","Dexamethasone PF, compounded by Pallimed Solutions Pharmacy, Woburn, MA","All lots within expiry",,,"Lack of Assurance of Sterility; FDA inspectional findings resulted in concerns associated with quality control procedures that impacted sterility assurance",3/25/2013,"03/25/2013",8/21/2013,"08/21/2013"
"Drugs",64716,"Completed","Pallimed Solutions","Woburn","MA","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Nationwide","D-870-2013","Class II","Hydroxyprogesterone CAPR.(G.S.), compounded by Pallimed Solutions Pharmacy, Woburn MA","All lots within expiry",,,"Lack of Assurance of Sterility; FDA inspectional findings resulted in concerns associated with quality control procedures that impacted sterility assurance",3/25/2013,"03/25/2013",8/21/2013,"08/21/2013"
"Drugs",64716,"Completed","Pallimed Solutions","Woburn","MA","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Nationwide","D-877-2013","Class II","Testosterone Cypionate/Propionate Injection, compounded by Pallimed Solutions Pharmacy, Woburn, MA","All lots within expiry",,"10 vials","Lack of Assurance of Sterility; FDA inspectional findings resulted in concerns associated with quality control procedures that impacted sterility assurance",3/25/2013,"03/25/2013",8/21/2013,"08/21/2013"
"Drugs",64716,"Completed","Pallimed Solutions","Woburn","MA","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Nationwide","D-876-2013","Class II","Testosterone Cypionate/Testosterone Enanthate Injection, compounded by Pallimed Solutions Pharmacy, Woburn, MA","All lots within expiry",,,"Lack of Assurance of Sterility; FDA inspectional findings resulted in concerns associated with quality control procedures that impacted sterility assurance",3/25/2013,"03/25/2013",8/21/2013,"08/21/2013"
"Drugs",64716,"Completed","Pallimed Solutions","Woburn","MA","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Nationwide","D-874-2013","Class II","Quadmix Injection, compounded by Pallimed Solutions Pharmacy, Woburn, MA","All lots within expiry",,"2 vials","Lack of Assurance of Sterility; FDA inspectional findings resulted in concerns associated with quality control procedures that impacted sterility assurance",3/25/2013,"03/25/2013",8/21/2013,"08/21/2013"
"Drugs",64716,"Completed","Pallimed Solutions","Woburn","MA","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Nationwide","D-872-2013","Class II","MIC with B6 and B12, compounded by Pallimed Solutions Pharmacy, Woburn, MA","All lots within expiry",,"18 vials","Lack of Assurance of Sterility; FDA inspectional findings resulted in concerns associated with quality control procedures that impacted sterility assurance",3/25/2013,"03/25/2013",8/21/2013,"08/21/2013"
"Drugs",64716,"Completed","Pallimed Solutions","Woburn","MA","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Nationwide","D-869-2013","Class II","HCG Chorionic Gonadotropin, compounded by Pallimed Solutions Pharmacy, Woburn, MA","All lots within expiry",,"261 vials","Lack of Assurance of Sterility; FDA inspectional findings resulted in concerns associated with quality control procedures that impacted sterility assurance",3/25/2013,"03/25/2013",8/21/2013,"08/21/2013"
"Drugs",64716,"Completed","Pallimed Solutions","Woburn","MA","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Nationwide","D-861-2013","Class II","BiMix Injection, compounded by Pallimed Solutions Pharmacy, Woburn, MA","All lots within expiry",,"246 vials","Lack of Assurance of Sterility; FDA inspectional findings resulted in concerns associated with quality control procedures that impacted sterility assurance",3/25/2013,"03/25/2013",8/21/2013,"08/21/2013"
"Drugs",64716,"Completed","Pallimed Solutions","Woburn","MA","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Nationwide","D-860-2013","Class II","Bacteriostatic Water for Injection, compounded by Pallimed Solutions Pharmacy, Woburn, MA","All lots within expiry",,,"Lack of Assurance of Sterility; FDA inspectional findings resulted in concerns associated with quality control procedures that impacted sterility assurance",3/25/2013,"03/25/2013",8/21/2013,"08/21/2013"
"Drugs",64716,"Completed","Pallimed Solutions","Woburn","MA","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Nationwide","D-858-2013","Class II","Alprostadil IN NS Injection, compounded by Pallimed Solutions Pharmacy, Woburn, MA","All lots within expiry",,"408 vials","Lack of Assurance of Sterility; FDA inspectional findings resulted in concerns associated with quality control procedures that impacted sterility assurance",3/25/2013,"03/25/2013",8/21/2013,"08/21/2013"
"Drugs",64716,"Completed","Pallimed Solutions","Woburn","MA","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Nationwide","D-864-2013","Class II","Cyclosporine Ophthalmic, compounded by Pallimed Solutions Pharmacy, Woburn, MA","All lots within expiry",,,"Lack of Assurance of Sterility; FDA inspectional findings resulted in concerns associated with quality control procedures that impacted sterility assurance",3/25/2013,"03/25/2013",8/21/2013,"08/21/2013"
"Drugs",64716,"Completed","Pallimed Solutions","Woburn","MA","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Nationwide","D-863-2013","Class II","Cidofovir Opthalmic Solution, compounded by Pallimed Solutions Pharmacy, Woburn, MA","All lots within expiry",,"23 vials","Lack of Assurance of Sterility; FDA inspectional findings resulted in concerns associated with quality control procedures that impacted sterility assurance",3/25/2013,"03/25/2013",8/21/2013,"08/21/2013"
"Drugs",64716,"Completed","Pallimed Solutions","Woburn","MA","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Nationwide","D-878-2013","Class II","Testosterone Cypionate Injection,compounded by Pallimed Solutions Pharmacy, Woburn, MA","All lots within expiry",,"597 vials","Lack of Assurance of Sterility; FDA inspectional findings resulted in concerns associated with quality control procedures that impacted sterility assurance",3/25/2013,"03/25/2013",8/21/2013,"08/21/2013"
"Drugs",64716,"Completed","Pallimed Solutions","Woburn","MA","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Nationwide","D-881-2013","Class II","Verapamil Injection, compounded by Pallimed Solutions Pharmacy, Woburn, MA","All lots within expiry",,,"Lack of Assurance of Sterility; FDA inspectional findings resulted in concerns associated with quality control procedures that impacted sterility assurance",3/25/2013,"03/25/2013",8/21/2013,"08/21/2013"
"Drugs",64716,"Completed","Pallimed Solutions","Woburn","MA","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Nationwide","D-867-2013","Class II","DMSO Aqueous Irrigation 50%, compounded by Pallimed Solutions Pharmacy, Woburn, MA","All lots within expiry",,"3 vials","Lack of Assurance of Sterility; FDA inspectional findings resulted in concerns associated with quality control procedures that impacted sterility assurance",3/25/2013,"03/25/2013",8/21/2013,"08/21/2013"
"Drugs",64716,"Completed","Pallimed Solutions","Woburn","MA","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Nationwide","D-859-2013","Class II","Atropine Injection, compounded by Pallimed Solutions Pharmacy, Woburn, MA","All lots within expiry",,,"Lack of Assurance of Sterility; FDA inspectional findings resulted in concerns associated with quality control procedures that impacted sterility assurance",3/25/2013,"03/25/2013",8/21/2013,"08/21/2013"
"Drugs",64716,"Completed","Pallimed Solutions","Woburn","MA","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Nationwide","D-871-2013","Class II","Methylcobalamin PF, compounded by Pallimed Solutions Pharmacy, Woburn, MA","All lots within expiry",,"3 vials","Lack of Assurance of Sterility; FDA inspectional findings resulted in concerns associated with quality control procedures that impacted sterility assurance",3/25/2013,"03/25/2013",8/21/2013,"08/21/2013"
"Drugs",64716,"Completed","Pallimed Solutions","Woburn","MA","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Nationwide","D-857-2013","Class II","Acetylcysteine Ophthalmic Solution, compounded by Pallimed Solutions Pharmacy, Woburn, MA","All lots within expiry",,"1 vial","Lack of Assurance of Sterility; FDA inspectional findings resulted in concerns associated with quality control procedures that impacted sterility assurance",3/25/2013,"03/25/2013",8/21/2013,"08/21/2013"
"Drugs",64716,"Completed","Pallimed Solutions","Woburn","MA","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Nationwide","D-875-2013","Class II","Tacrolimus Ophthalmic, Pallimed Solutions Pharmacy, Woburn, MA","All lots within expiry",,,"Lack of Assurance of Sterility; FDA inspectional findings resulted in concerns associated with quality control procedures that impacted sterility assurance",3/25/2013,"03/25/2013",8/21/2013,"08/21/2013"
"Drugs",64716,"Completed","Pallimed Solutions","Woburn","MA","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Nationwide","D-862-2013","Class II","Buprenorphine HCl Veterinary Injection, compounded by Pallimed Solutions Pharmacy, Woburn, MA","All lots within expiry",,"71 vials","Lack of Assurance of Sterility; FDA inspectional findings resulted in concerns associated with quality control procedures that impacted sterility assurance",3/25/2013,"03/25/2013",8/21/2013,"08/21/2013"
"Drugs",64716,"Completed","Pallimed Solutions","Woburn","MA","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Nationwide","D-873-2013","Class II","Nandrolone Decanoate Injectable, compounded by Pallimed Solutions Pharmacy, Woburn, MA","All lots within expiry",,"56 vials","Lack of Assurance of Sterility; FDA inspectional findings resulted in concerns associated with quality control procedures that impacted sterility assurance",3/25/2013,"03/25/2013",8/21/2013,"08/21/2013"
"Drugs",64716,"Completed","Pallimed Solutions","Woburn","MA","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Nationwide","D-868-2013","Class II","Gentamicin Sulfate Irrigation, compounded by Pallimed Solutions Pharmacy, Woburn, MA","All lots within expiry",,,"Lack of Assurance of Sterility; FDA inspectional findings resulted in concerns associated with quality control procedures that impacted sterility assurance",3/25/2013,"03/25/2013",8/21/2013,"08/21/2013"
"Food",64717,"Ongoing","Producers Peanut Company Inc","Suffolk","VA","US","Voluntary: Firm Initiated","Telephone","Distributed in New York, Virginia, Illinois, Maryland, and exported to Barbados.","F-1291-2013","Class II","Happy Kids Creamy Peanut Butter, packed in 8 oz, 12 oz, 28 oz, 40 oz jars; packed 12 jars/box and 6 jars/box (40 oz), and labeled in part ******Manufactured by Producers Peanut Co., Inc. 337 Moore Ave., Suffolk, VA 23434***","EXP 02.13.2015 ",".","1122 cs= 12798 lbs (creamy)","Peanut butter may contain aflatoxins above allowable levels.",3/14/2013,"03/14/2013",4/10/2013,"04/10/2013"
"Food",64717,"Ongoing","Producers Peanut Company Inc","Suffolk","VA","US","Voluntary: Firm Initiated","Telephone","Distributed in New York, Virginia, Illinois, Maryland, and exported to Barbados.","F-1294-2013","Class II","America Farm Peanut Granules, bulk packed in 30 lb plastic bags in a box, and labeled in part ***Manufactured by Producers Peanut Co., Inc. 337 Moore Ave., Suffolk, VA 23434***","2/12/2013, 2/13/2013, POD FEB 12 2013, POD FEB 2013, and 01.13.2015 ",".","1 box/30 lbs","Peanut butter may contain aflatoxins above allowable levels.",3/14/2013,"03/14/2013",4/10/2013,"04/10/2013"
"Food",64717,"Ongoing","Producers Peanut Company Inc","Suffolk","VA","US","Voluntary: Firm Initiated","Telephone","Distributed in New York, Virginia, Illinois, Maryland, and exported to Barbados.","F-1292-2013","Class II","Happy Kids Crunchy Peanut butter, packed in 8 oz, 12 oz, 28 oz, packed 12 jars/cs and 40 oz jars, packed 6 jars/cs; jars are labeled in part ***Manufactured by Producers Peanut Co., Inc. 337 Moore Ave., Suffolk, VA 23434***","EXP 02.13.2015 ",".","506 cs= 5760 lbs (crunchy)","Peanut butter may contain aflatoxins above allowable levels.",3/14/2013,"03/14/2013",4/10/2013,"04/10/2013"
"Food",64717,"Ongoing","Producers Peanut Company Inc","Suffolk","VA","US","Voluntary: Firm Initiated","Telephone","Distributed in New York, Virginia, Illinois, Maryland, and exported to Barbados.","F-1293-2013","Class II","Bulk Creamy/Smooth Peanut butter, packed in plastic 4 lb tub, packed 6 tubs/box; 5 lb tub, packed 6 tubs/box, and 35 lb buckets under private labels: Peanut Kids, Eden and American Farm Peanut Butters, and labeled in part ***Manufactured by Producers Peanut Co., Inc. 337 Moore Ave., Suffolk, VA 23434***","2/12/2013, 2/13/2013, POD FEB 12 2013, POD FEB 2013, and 01.13.2015 ",".","1101- 4 lb tubs; 573- 5 lb tubs; 181- 35 lb buckets; Total 49,949 lb","Peanut butter may contain aflatoxins above allowable levels.",3/14/2013,"03/14/2013",4/10/2013,"04/10/2013"
"Devices",64718,"Ongoing","Separation Technology, Inc.","Sanford","FL","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution-USA (nationwide) including the states of PA, NC, IL, KS, and FL, and the countries Canada and Turkey.","Z-1367-2013","Class II","SLIDERPREP PLUS SLIDE PREPARATION CENTRIFUGE. Produce a monolayer of cells onto a glass slide from any fluid suspension. ","Serial numbers: 0110, 0111, 0112, 0210, 0211, 0212, 0310, 0311, 0312, 0410, 0411, 0412, 0511, 0512, 0611, 0710, 0711, 0811, 0812, 0910, 0911, 0912, 1011, 1012, 1112, 1210, 1212.",".","102","Separation Technology, Inc. recalled SlidePrep Plus Cytology Centrifuges manufactured prior to January 1, 2013 for having the potential to start up unexpectedly when encountering an electrostatic discharge.",3/13/2013,"03/13/2013",5/29/2013,"05/29/2013"
"Drugs",64719,"Ongoing","Hospira Inc.","Lake Forest","IL","US","Voluntary: Firm Initiated","Letter","Nationwide.","D-223-2013","Class II","Propofol Injectable Emulsion, 1%, packaged in a) 5 x 20 mL Single patient infusion vials per carton, 200 mg/20 mL (10 mg/mL), NDC 0409-4699-30; b) 10 x 100 mL Single patient infusion vials per carton, 1 g/100 mL (10 mg/mL), NDC 0409-4699-24; Rx only, Hospira, Inc., Lake Forest, IL 60045 USA.","a) Lot #: 06-804-DJ*, Exp 1JUN2013; and b) Lot #: 05-736-DJ*, Exp 1MAY2013; 09-066-DJ*, Exp 1SEP2013. *Note: the lot number may be followed by 01 or 02.",,"68,020 vials","Presence of Particulate Matter: Visible particulate embedded in vials was observed and confirmed in a sample bottle during retain inspection.",2/25/2013,"02/25/2013",4/3/2013,"04/03/2013"
"Drugs",64720,"Ongoing","Hospira Inc.","Lake Forest","IL","US","Voluntary: Firm Initiated","Letter","Nationwide and Puerto Rico","D-308-2013","Class II","Preservative-Free MORPHINE Sulfate Injection, USP, 10 mg/10 mL (1 mg/mL) 10 mL vial, Rx only, HOSPIRA, INC, LAKE FOREST, IL 60045 USA NDC 0409-3815-12 ","Lot 15-065-DK, Exp 1SEP2013",,"26,100 vials","Lack of Assurance of Sterility: Loose crimp applied to the fliptop vial",8/28/2012,"08/28/2012",5/8/2013,"05/08/2013"
"Drugs",64720,"Ongoing","Hospira Inc.","Lake Forest","IL","US","Voluntary: Firm Initiated","Letter","Nationwide and Puerto Rico","D-309-2013","Class II","Diazepam Injection, USP 5 mg/mL, 10 mL, Multiple-dose fliptop vial, RX only, HOSPIRA, INC. LAKE FOREST, IL 60045 USA, NDC 0409-3213-12","Lot 17-100-EV and 17-399-EV",,"172,350 vials","Lack of Assurance of Sterility: Loose crimp applied to the fliptop vial.",8/28/2012,"08/28/2012",5/8/2013,"05/08/2013"
"Food",64721,"Ongoing","Decoty Coffee Company, Inc","San Angelo","TX","US","Voluntary: Firm Initiated","Letter","Mainly in TX, but internet sales were nationwide.","F-1276-2013","Class II","Taco Seasoning, Net Wt. 1.25 lb and 5.75 lb. Distributed by Decoty Coffee Company, San Angelo, TX 76903, 800-588-8001. The products come in 1.25lb and 5.75lb sizes and are distributed in plastic spice containers with resealable lids.","The item code numbers are 71400 (1.25 lb) and 71410 (5.75 lb) with lot numbers from 010111 through 021313.",,"205 of the 1.25 lb and 310 of the 5.75 lb","Recently, DeCoty Taco Seasoning, 1.25 lb (Lot numbers 010111-021313) and 5.75 lb (Lot numbers 010111-021313), were recalled for the undeclared ingredient Soy. Tests show that these lot numbers of this product also contain the undeclared ingredient Wheat Gluten, therefore represents a potential health hazard. ",3/25/2013,"03/25/2013",4/3/2013,"04/03/2013"
"Drugs",64722,"Ongoing","NuVision Pharmacy, Inc.","Dallas","TX","US","Voluntary: Firm Initiated","Letter","FL, MO, UT, and WA.","D-417-2013","Class II","Methylcobalamin (Buffered) Injection,1 mg/mL, 30 mL vial, Stock# 11126, Preservative Free, Compounded by NuVision Pharmacy, Inc., Dallas, TX 75244","Lot Number N01232013@4, Do Not Use Beyond Date of January 1, 2014",,"32 vials","Lack of Assurance of Sterility; reports of adverse events after injection",3/28/2013,"03/28/2013",5/22/2013,"05/22/2013"
"Devices",64723,"Ongoing","Horiba Instruments, Inc dba Horiba Medical","Irvine","CA","US","Voluntary: Firm Initiated","Letter","Nationwide Distribution.","Z-1141-2013","Class II","HORIBA ABX PENTRA 400 I.S.E. Module, Model Numbers: P400ISE110EN02 and P400ISE110US02, All Serial Numbers, Software Versions 5.0.7 and Below. Used to measure absorbance and ion electrodes. ","Model Numbers: P400ISE110EN02 and P400ISE110US02. All Serial Numbers. Versions 5.0.7 and below",".","905 units","HORIBA Medical is informing all ABX PENTRA 400 Analyzer with I.S.E. Module customers that there are no Linearity Limit Flags for the I.S.E. assays currently programmed into the ABX PENTRA 400 Analyzer software. All other assays run on this analyzer do have Linearity Limit Flags to alert the user to values that fall below or above the validated linearity range for each assay.",3/20/2013,"03/20/2013",4/24/2013,"04/24/2013"
"Devices",64725,"Ongoing","GE Healthcare, LLC","Waukesha","WI","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution, USA, including the states of AL, AZ, AR, CA, CO,K CT, DC, FL, GA, IL, IN, IA, KS, KY, LA, MD, MA, MI, MN, MS, MO, MT NE, NV N NJ, NM, NY, NC, ND, OH, OK, PA, RI ,SC, SD, TN, TX, VA, WA, WI and the countries of AUSTRALIA, AUSTRIA, BRAZIL, CANDA, CHILE, CHINA, COSTA ARICA, CROATIA, CZECH REPUBLIC, DENMARK, FINLAND, FRANCE, GERMANY, GREECE, HONG KONG, HUNGARY INDIA, INDONESIA ITALY JAPAN, KOREA, LATVIA, LEBANON, MALAYSIA, MEXICO, MOLDOVA, MOROCCO, NETHERLANDS, NEW ZEALAND, NORWAY, PHILIPPINES, POLAND, PORTUGAL, ROMANIA, RUSSIA, SAUDI ARABIA, SINGAPORE, SLOVENIA, SOUTH AFRICA , SOUTH KOREA, SPAIN, SWEDEN, SWITZERLAND, TAIWAN, THAILAND, TUNISIA, TURKEY, UNITED ARAB EMIRATES, UNITED KINGDOM, VIETNAM.","Z-1096-2013","Class II","GE Healthcare LOGIQ S8 (with software revisions R1.1.1 and R1.5.1) and LOGIQ S7 (with software revisions R1.0.1, R1.0.2 and R1.0.3) diagnostic ultrasound system with the S4-10-D Ultrasound Probe. The device is intended for use in ultrasound evaluation.","176132SU9 176138SU6 178028SU7 158247SU7 172656SU1 187599SU6 201614SU5 201615SU2 195234SU0 195237SU3 161686SU1 203123SU5 170272SU9 189160SU5 189162SU1 170273SU7 185619SU4 176924SU9 191894SU5 159964SU6 159768SU1 170197SU8 158248SU5 171540SU8 171541SU6 160741SU5 160742SU3 160743SU1 159766SU5 197761SU0 198949SU0 195241SU5 189928SU5 164268SU5 159963SU8 185116SU1 195242SU3 201967SU7 166218SU8 185968SU5 189165SU4 189166SU2 189167SU0 189168SU8 189169SU6 195235SU7 195236SU5 171371SU8 168779SU7 189163SU9 190393SU9 159767SU3 167274SU0 201464SU5 195233SU2 171369SU2 177085SU8 186501SU3 171370SU0 187022SU9 191063SU7 185969SU3 168788SU8 159965SU3 201612SU9 159604SU8 178592SU2 178593SU0 178594SU8 178595SU5 185620SU2 185621SU0 176926SU4 176925SU6 191893SU7 177084SU1 192952SU0 195238SU1 195239SU9 195240SU7 201971SU9 201972SU7 202046SU9 195881SU8 186579SU9 204275SU2 171542SU4 171947SU5 192951SU2 201906SU5 204921SU1 204922SU9 204923SU7 204924SU5 204925SU2 189161SU3 181434SU2 158768SU2 183107SU2 166181SU8 169509SU7 170671SU2 187015SU3 187014SU6 183118SU9 170672SU0 176130SU3 182380SU6 188131SU7 188121SU8 159776SU4 159792SU1 191471SU2 182223SU8 182222SU0 183104SU9 166172SU7 197249SU6 194194SU7 168080SU0 195876SU8 198407SU9 190385SU5 190754SU2 190390SU5 182654SU4 182655SU1 182656SU9 189924SU4 176566SU8 176567SU6 190752SU6 190753SU4 194561SU7 194562SU5 194563SU3 194564SU1 194565SU8 196258SU8 183907SU5 200715SU1 188545SU8 176939SU7 190505SU8 190506SU6 190507SU4 192947SU0 180973SU0 183102SU3 176938SU9 185798SU6 200709SU4 180363SU4 183660SU0 183661SU8 189354SU4 202264SU8 192059SU4 192060SU2 192116SU2 192115SU4 193638SU4 199071SU2 192120SU4 183470SU4 183471SU2 183472SU0 183473SU8 186887SU6 192058SU6 192061SU0 192062SU8 192063SU6 192065SU1 192105SU5 192110SU5 192114SU7 192119SU6 192546SU0 192547SU8 192548SU6 192549SU4 192550SU2 192551SU0 192552SU8 192553SU6 193342SU3 194554SU2 196884SU1 196885SU8 197658SU8 197760SU2 198879SU9 199237SU9 199238SU7 199239SU5 200704SU5 200706SU0 200717SU7 201237SU5 201238SU3 201239SU1 201616SU0 201617SU8 20190",,"2061","GE Healthcare has become aware of a potential safety issue due to the S4-10-D Ultrasound Probe used in conjunction with the LOGIQ S8 and LOGIQ S7 Ultrasound systems. It was also discovered that this issue also leads to a specification issue of the acoustic output of this probe. There is a potential for a skin burn when the flow model in the cardiac application is activated with the S4-10-D Ultrasound probe.",2/8/2013,"02/08/2013",4/17/2013,"04/17/2013"
"Veterinary",64726,"Ongoing","JDJ Manufacturing, LLC","Aumsville","OR","US","Voluntary: Firm Initiated","E-Mail","directly distributed to California","V-293-2013","Class I","Variety Pack 04107, consists of one retail unit of BARF Combo, Beef, Chicken, and Lamb product. There are total 4 individual units per case. There is NO UPC for this product.","Lot 214. USE BY 08-01-13. Individual unit in this case bears LOT# T209, LOT# E212, LOt# E209, and LOT # T214.",".","199 cases/4 packs","Variety Pack from lot 214 sold under BARF brand are recalled due to a potential contamination with Salmonella.",3/21/2013,"03/21/2013",8/14/2013,"08/14/2013"
"Veterinary",64726,"Ongoing","JDJ Manufacturing, LLC","Aumsville","OR","US","Voluntary: Firm Initiated","E-Mail","directly distributed to California","V-291-2013","Class I","BARF Juicy Combo Recipe Patties, 12 pieces per bag, 6 lbs. bag, 4 bags per case, sold under BARF brand name. The UPC is 8 37528 00106 2.","Lot 209. USE BY 7/27/2013.",".","42 cases/4 bags/6 lbs.","BARF Juicy Combo Recipe patties from lot 209 sold under BARF brand are recalled due to a potential contamination with Salmonella.",3/21/2013,"03/21/2013",8/14/2013,"08/14/2013"
"Veterinary",64726,"Ongoing","JDJ Manufacturing, LLC","Aumsville","OR","US","Voluntary: Firm Initiated","E-Mail","directly distributed to California","V-290-2013","Class I","BARF Juicy Lamb Recipe contains 12 Lamb Patties per bag, 6 lbs. bag, 4 bags per case, sold under BARF brand name. The UPC is 8 37528 00104 8.","Lot 209. USE BY 7/27/2013.",".","68 cases/4 bags/6 lbs.","BARF Juicy Lamb Recipe patties from lot 209 sold under BARF brand are recalled due to a potential contamination with Salmonella.",3/21/2013,"03/21/2013",8/14/2013,"08/14/2013"
"Veterinary",64726,"Ongoing","JDJ Manufacturing, LLC","Aumsville","OR","US","Voluntary: Firm Initiated","E-Mail","directly distributed to California","V-292-2013","Class I","Combo Diet Bulk Pack 06306, 24 lbs. bag, sold under BARF brand name. There is no UPC for this item.","Lot 209. USE BY 07-27-13",".","42 cases/24 lbs.","Combo Bulk from lot 209 sold under BARF brand are recalled due to a potential contamination with Salmonella.",3/21/2013,"03/21/2013",8/14/2013,"08/14/2013"
"Devices",64728,"Ongoing","Carefusion Corporation","San Diego","CA","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution - USA (nationwide) and the countries of Australia and China.","Z-1098-2013","Class I","Alaris PC unit model 8015 with software version 9.12 Product Usage: The Alaris PC unit is the central programming, monitoring and power supply component for the Alaris System.","unit model 8015 with software version 9.12 ",".","9,241 units","The recall was initiated because Carefusion has received reports of a communication error on the Alaris PC unit model 8015 with software version 9.12 when the Alaris EtCO2 module or Alaris SpO2 module is attached. ",3/6/2013,"03/06/2013",4/24/2013,"04/24/2013"
"Drugs",64729,"Ongoing","L. Perrigo Co.","Allegan","MI","US","Voluntary: Firm Initiated","Letter","Nationwide","D-318-2013","Class III","Liothyronine Sodium Tablets, USP, 5 mcg Rx ONLY, 100 count bottle, Distributed by: PaddockLaboratories, Inc., Minneapolis, MN 55427, NDC 0574-0220-01,","12K714 exp. 12/13, 12K715 exp. 12/13",".","21,667 bottles","Failed Impurities/Degradation Specifications: Perrigo is conducting a wholesale level recall of two batches of this product due to an out of specification impurity result during three month stability testing. ",3/12/2013,"03/12/2013",5/15/2013,"05/15/2013"
"Devices",64730,"Ongoing","Ge Healthcare It","Barrington","IL","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution - USA including AK, AL, AR, AZ, CA, CO, CT, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, WA, WI, WV, WY, District of Columbia, Puerto Rico, and the U.S. Virgin Islands. Internationally to Austria, Azerbaijan, Bahrain, Belgium, Bosnia, Brazil, Canada, Columbia, Egypt, France, Germany, Ghana, Hungary, Ireland, Israel, Italy, Japan, Kuwait, Lebanon, Libya, Lithuania, Mexico, Netherlands, Nigeria, Palestine, Poland, Qatar, Russia, Saudi Arabia, Slovenia, South Africa, Spain, Switzerland, Turkey, United Arab Emirates, United Kingdom, Uzbekistan, and Yemen. Center Recommended Depth - Consumers/User**","Z-0118-2014","Class II","Centricity PACS IW by GE Healthcare Dynamic Imaging Solutions is a device that receives medical images (including mammograms) and data from various imaging sources. Images and data can be stored, communicated, processed and displayed within the system or across computer networks at distributed locations. Lossy compressed mammographic images and digitized film screen images may only be interpreted using an FDA approved monitor that offers at least 5 M pixel resolution and meets other technical specifications reviewed and accepted by the FDA. Typical users of this system are trained professionals, including but not limited to physicians, radiologists, nurses, medical technicians an assistants. ","Software Versions: 3.7.1, 3.7.1.1, 3.7.2, 3.7.3.1, 3.7.3.3, 3.7.3.4, 3.7.3.5, 3.7.6.3, 3.7.3.7, and 3.7.3.8",,"847 units","Multiple issues were identified with the GE Centricity PACS-IW system that could pose a safety risk to patients. These issues include: 1) With Auto-Fetch in use another patient's image may appear without user's intention. 2.a) In the case where dose administration time and image acquisition time fall on either side of midnight, the value will be under reported and close to zero for all pixel. 2.b) Decay correction tag (0054,1102) has a value ''ADMIN'' and the value reported will be exceedingly high. 2.c) In the ''BQML'' case where StartDateTime tag (0018,1078) is provided in place of StartTime (0018,1078) no value is reported and instead shows as ''not calibrated''. 3) For multi-frame images that contain more than one overlay, studies with frames where overlays overlap, the wrong overlay is displayed. For studies with frames that should display one overlay for specified amount of frames and a second overlay for specified amount of frames, no overlays are displayed at all.",6/15/2012,"06/15/2012",11/6/2013,"11/06/2013"
"Devices",64731,"Ongoing","Beckman Coulter Inc.","Brea","CA","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution - USA, including Canada and Puerto Rico and the states of NJ, TX, CA, UT, KS, MA, NY, MI, GA, VA, IN, WI, IL, OH, NV, NC and PA. and the countries of Australia, Belgium, Czech Republic, Japan, Germany, Brazil, China, Italy, Ireland, Israel, India, Hong Kong, Malaysia, Netherlands, Spain, Switzerland, France, Taiwan, Turkey, United Kingdom and Vietnam.","Z-1167-2013","Class II","AU5800 Clinical Chemistry Analyzer The Beckman Coulter AU5800 Clinical Chemistry Analyzer is an automated chemistry analyzer that measures analytes in samples, in combination with appropriate reagents, calibrators, quality control (QC) material and other accessories. This system is for in vitro diagnostic use only. Applications include colorimetric, turbidimetric, latex agglutination, homogeneous enzyme immunoassay, and in selective electrode.","All Instrument Serial Numbers with Software Versions 4.11 and Prior Model Numbers AU5811-01, AU5821-01, AU5831-01, AU5841-01, AU5811-02, AU5821-02, AU5831-02, AU5841-02, AU5811-03, AU5821-03, AU5831-03, AU5841-03, AU5811-04, AU5821-04, AU5831-04, AU5841-04, AU5811-06, AU5821-06, AU5831-06, AU5841-06 Part Numbers A94906, A94911, A94916, A91921 A94907, A94912, A94917, A94922 A94908, A94913, A94918, A94923 A94909, A94914, A91949, A94924 A94910, A94915, A94920, A94925 Model Numbers and Part Numbers listed above respecitively. ",".","490","Beckman Coulter, Inc. initiated this recall because there is a software error that has the potential to cause the reporting of erroneous patient results because of misidentification by the AU5800 system.",3/20/2013,"03/20/2013",5/1/2013,"05/01/2013"
"Veterinary",64732,"Ongoing","Virbac Corporation","Bridgeton","MO","US","Voluntary: Firm Initiated",,"CA, FL, HI, IA, IN, KS, MD, MI, MN, MO, MS, NE, NJ, NM, OK, OR, PA, TN, TX, WI, Firm also distributed to PR and Korea","V-214-2013","Class III","Iverhart Plus (ivermectin/pyrantel) Flavored Chewables to prevent heartworm disease and control ascarid and hookworm infections in dog","Product number 0170DM - lot 120202 ",,"units of 10 cards with 6 tablets each","Firm testing found recalled lots to be out of specification with sub-potent results.",3/26/2013,"03/26/2013",7/3/2013,"07/03/2013"
"Veterinary",64732,"Ongoing","Virbac Corporation","Bridgeton","MO","US","Voluntary: Firm Initiated",,"CA, FL, HI, IA, IN, KS, MD, MI, MN, MO, MS, NE, NJ, NM, OK, OR, PA, TN, TX, WI, Firm also distributed to PR and Korea","V-212-2013","Class III","Worm Shield (ivermectin/pyrantel) Flavored Chewables to prevent heartworm disease and to treat and control ascarid and hookworm infections in dogs. Hannah Pharmaceuticals Manufactured for Schuyler LLC Portland OR","Product number 0210DS - lots:120844 and 120196 ",,"units with 6 tablets each","Firm testing found recalled lots to be out of specification with sub-potent results.",3/26/2013,"03/26/2013",7/3/2013,"07/03/2013"
"Veterinary",64732,"Ongoing","Virbac Corporation","Bridgeton","MO","US","Voluntary: Firm Initiated",,"CA, FL, HI, IA, IN, KS, MD, MI, MN, MO, MS, NE, NJ, NM, OK, OR, PA, TN, TX, WI, Firm also distributed to PR and Korea","V-211-2013","Class III","Ivermectin/pyrantel flavored chewables for dogs up to 25 lbs., each tablet contains 68 mcg. ivermectin and 57 mg. pyrantel as pamoate salt, RX, ANADA 200-302, packaged with the following brand names and configurations: (1) Virbac Animal Health Iverhart Plus Flavored Chewables, packaged 6 tablets per box, 10 boxes per display, product #0170DS. Manufactured by: Virbac AH, Inc., Fort Worth, TX; (2) Wormshield Flavored Chewables Hannah Pharmaceuticals, packaged 6 tablets per box, 10 boxes per display, product #0210DS. Manufactured for: Schuyler LLC, Portland, OR; and (3)Virbac Animal Health Iverhart Plus Puppy Pac, promotional Information packet containing 1 tablet, product #01800. Manufactured by: Virbac AH, Inc., Fort Worth, TX; ","Iverhart Plus and Wormshield lots:120844 and 120196: Puppy Pac lot 120844 only",,"units with 6 tablets each.","Firm testing found recalled lots to be out of specification with sub-potent results.",3/26/2013,"03/26/2013",7/3/2013,"07/03/2013"
"Veterinary",64732,"Ongoing","Virbac Corporation","Bridgeton","MO","US","Voluntary: Firm Initiated",,"CA, FL, HI, IA, IN, KS, MD, MI, MN, MO, MS, NE, NJ, NM, OK, OR, PA, TN, TX, WI, Firm also distributed to PR and Korea","V-213-2013","Class III","Worm Shield (ivermectin/pyrantel) Flavored Chewables to prevent heartworm disease and to treat and control ascarid and hookworm infections in dogs. Hannah Pharmaceuticals Manufactured for Schuyler LLC Portland OR","Product number 0210DM - lots:120202 and 120845",,"units with 6 tablets each","Firm testing found recalled lots to be out of specification with sub-potent results.",3/26/2013,"03/26/2013",7/3/2013,"07/03/2013"
"Veterinary",64732,"Ongoing","Virbac Corporation","Bridgeton","MO","US","Voluntary: Firm Initiated",,"CA, FL, HI, IA, IN, KS, MD, MI, MN, MO, MS, NE, NJ, NM, OK, OR, PA, TN, TX, WI, Firm also distributed to PR and Korea","V-215-2013","Class III","Iverhart Plus (ivermectin/pyrantel) Flavored Chewables to prevent heartworm disease and control ascarid and hookworm infections in dog","Product number 0170DL - lots:120856; 120076 and 120086 ",,"units of 10 cards with 6 tablets each.","Firm testing found recalled lots to be out of specification with sub-potent results.",3/26/2013,"03/26/2013",7/3/2013,"07/03/2013"
"Drugs",64733,"Ongoing","Dr. Reddy'S Laboratories","Bridgewater","NJ","US","Voluntary: Firm Initiated","Letter","Nationwide and Puerto Rico.","D-238-2013","Class III","Tizanidine Tablets USP, 4 mg, 150-count tablets per bottle, Rx Only, Mfd. By: Dr. Reddy's Laboratories Limited, Bachepally - 500 090 India; NDC 55111-180-15.","Lot #: C208625, C208984, C209113, C209369, Exp 09/15; and C209680, Exp 10/15.",".","117,546 bottles","Labeling Illegible: There is a possibility that the bottle labels do not contain the strength of the product as well as other printing details. ",3/19/2013,"03/19/2013",4/10/2013,"04/10/2013"
"Devices",64734,"Ongoing","DeGotzen","Olgiate Olona Varese",,"IT","Voluntary: Firm Initiated","Letter","US (nationwide)","Z-1020-2013","Class II","DeGotzen XRay unit XGenus Dental X-ray unit.","766471 ",".","159 units","It was discovered at the WEAC Labs method sample did not meet requirements for labeling and certification",9/26/2012,"09/26/2012",4/24/2013,"04/24/2013"
"Food",64735,"Ongoing","Nestle Puerto Rico Inc","Catano","PR","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Product was distributed in Puerto Rico only (wholesalers and distributors).","F-1324-2013","Class III","GERBER Pure Water (1 Plastic Gallon)","Manufactured- 2/20/13 - 3/22/13- 3.79L (1 Gallon) 1304948683, 1305048682, 1305048683, 1305148682, 1305348683, 1305648682, 1305648683, 1305748682, 1306048682, 1306348681, 1306548682, 1306648681, 1306748682, 1307048682, 1307348681",".","12,948 - (3 gallons cases)","An audit to the purified water supplier revealed deficiencies related to the Ozone purification system and particulates, the analytical results show that mold was found on one of the batches",3/19/2013,"03/19/2013",4/24/2013,"04/24/2013"
"Devices",64736,"Ongoing","Cardinal Health, Medical Products & Services","Park City","IL","US","Voluntary: Firm Initiated","Letter","Distributed in the states of AR, MS, SC, and TN.","Z-1201-2013","Class I","Presource PBDS, Shoulder Procedure, Kit, Circulator","Catalog Number: PO24SHNPC01; Lots: 843685, 864636, 875004, 893118, 901720, 924132, 934399, 959120, 968668 ",".","4,571 Kits total","Various Presource Kits contain a pre-assembled Filter and Anesthesia Circuit that may contain outer plastic packaging on one or more components. If the packaging is removed without disassembling the components, remnants of the plastic from the packaging material may become lodged in the filter potentially causing an obstruction of airflow.",3/26/2013,"03/26/2013",5/15/2013,"05/15/2013"
"Devices",64736,"Ongoing","Cardinal Health, Medical Products & Services","Park City","IL","US","Voluntary: Firm Initiated","Letter","Distributed in the states of AR, MS, SC, and TN.","Z-1194-2013","Class I","A) Presource PBDS, Lap Chole, Kit, Clean Up; B) Presource PBDS, Greenwood LeFlore Hosp, Lap Chole, Kit","A) Catalog Number: PG24LCGWG02; Lots: 153502, 162892, 170494, 180482, , 88701, 193548, 198163, 206986; B) Catalog Number: PG24LCGWG; Lots:153502, 162892, 170494, 180482, 188701, 193548, 198163, 206986",".","4,571 Kits total","Various Presource Kits contain a pre-assembled Filter and Anesthesia Circuit that may contain outer plastic packaging on one or more components. If the packaging is removed without disassembling the components, remnants of the plastic from the packaging material may become lodged in the filter potentially causing an obstruction of airflow.",3/26/2013,"03/26/2013",5/15/2013,"05/15/2013"
"Devices",64736,"Ongoing","Cardinal Health, Medical Products & Services","Park City","IL","US","Voluntary: Firm Initiated","Letter","Distributed in the states of AR, MS, SC, and TN.","Z-1198-2013","Class I","Presource PBDS, Extremity, Kit, Circulator","Catalog Number: PO24EXNPD01; Lots: 852429, 868825, 883022, 896400, 914524, 929984, 941696, 954317 ",".","4,571 Kits total","Various Presource Kits contain a pre-assembled Filter and Anesthesia Circuit that may contain outer plastic packaging on one or more components. If the packaging is removed without disassembling the components, remnants of the plastic from the packaging material may become lodged in the filter potentially causing an obstruction of airflow.",3/26/2013,"03/26/2013",5/15/2013,"05/15/2013"
"Devices",64736,"Ongoing","Cardinal Health, Medical Products & Services","Park City","IL","US","Voluntary: Firm Initiated","Letter","Distributed in the states of AR, MS, SC, and TN.","Z-1202-2013","Class I","Presource PBDS, Total Hip, Kit, Circulator","Catalog Number: PO24THGWG01; Lots: 966051, 970753 ",".","4,571 Kits total","Various Presource Kits contain a pre-assembled Filter and Anesthesia Circuit that may contain outer plastic packaging on one or more components. If the packaging is removed without disassembling the components, remnants of the plastic from the packaging material may become lodged in the filter potentially causing an obstruction of airflow.",3/26/2013,"03/26/2013",5/15/2013,"05/15/2013"
"Devices",64736,"Ongoing","Cardinal Health, Medical Products & Services","Park City","IL","US","Voluntary: Firm Initiated","Letter","Distributed in the states of AR, MS, SC, and TN.","Z-1195-2013","Class I","Presource PBDS, General Laparoscopy, Kit, Circulator","Catalog Number: PG24LGNPC01; Lots: 147492, 152554, 160275, 165822, 173745, 180700, 186904, 195042, 205901, 836989 ",".","4,571 Kits total","Various Presource Kits contain a pre-assembled Filter and Anesthesia Circuit that may contain outer plastic packaging on one or more components. If the packaging is removed without disassembling the components, remnants of the plastic from the packaging material may become lodged in the filter potentially causing an obstruction of airflow.",3/26/2013,"03/26/2013",5/15/2013,"05/15/2013"
"Devices",64736,"Ongoing","Cardinal Health, Medical Products & Services","Park City","IL","US","Voluntary: Firm Initiated","Letter","Distributed in the states of AR, MS, SC, and TN.","Z-1199-2013","Class I","Presource PBDS, Hand, Kit, Circulator","Catalog Number: PO24HKGWG01; Lots: 856515, 875680, 894983, 905021, 929987, 932368, 946822, 954543, 968547 ",".","4,571 Kits total","Various Presource Kits contain a pre-assembled Filter and Anesthesia Circuit that may contain outer plastic packaging on one or more components. If the packaging is removed without disassembling the components, remnants of the plastic from the packaging material may become lodged in the filter potentially causing an obstruction of airflow.",3/26/2013,"03/26/2013",5/15/2013,"05/15/2013"
"Devices",64736,"Ongoing","Cardinal Health, Medical Products & Services","Park City","IL","US","Voluntary: Firm Initiated","Letter","Distributed in the states of AR, MS, SC, and TN.","Z-1197-2013","Class I","Presource PBDS, Knee Arthroscopy, Kit, Circulator","Catalog Number: PO24AKNPC01; Lots: 851288, 877594, 901672, 917786, 948443, 972424 ",".","4,571 Kits total","Various Presource Kits contain a pre-assembled Filter and Anesthesia Circuit that may contain outer plastic packaging on one or more components. If the packaging is removed without disassembling the components, remnants of the plastic from the packaging material may become lodged in the filter potentially causing an obstruction of airflow.",3/26/2013,"03/26/2013",5/15/2013,"05/15/2013"
"Devices",64736,"Ongoing","Cardinal Health, Medical Products & Services","Park City","IL","US","Voluntary: Firm Initiated","Letter","Distributed in the states of AR, MS, SC, and TN.","Z-1205-2013","Class I","Presource PBDS, Beaufort Memorial Hospital, Anesthesia Circuit, Kit","Catalog Number:PZ23ANBUG; Lot: 200710",".","4,571 Kits total","Various Presource Kits contain a pre-assembled Filter and Anesthesia Circuit that may contain outer plastic packaging on one or more components. If the packaging is removed without disassembling the components, remnants of the plastic from the packaging material may become lodged in the filter potentially causing an obstruction of airflow.",3/26/2013,"03/26/2013",5/15/2013,"05/15/2013"
"Devices",64736,"Ongoing","Cardinal Health, Medical Products & Services","Park City","IL","US","Voluntary: Firm Initiated","Letter","Distributed in the states of AR, MS, SC, and TN.","Z-1200-2013","Class I","Presource PBDS, Shoulder Arthroscopy, Kit, Circulator","Catalog Number: PO24SAGWF01; Lots: 847129, 877843, 905183, 931801, 935180, 946651, 957422, 969585 ",".","4,571 Kits total","Various Presource Kits contain a pre-assembled Filter and Anesthesia Circuit that may contain outer plastic packaging on one or more components. If the packaging is removed without disassembling the components, remnants of the plastic from the packaging material may become lodged in the filter potentially causing an obstruction of airflow.",3/26/2013,"03/26/2013",5/15/2013,"05/15/2013"
"Devices",64736,"Ongoing","Cardinal Health, Medical Products & Services","Park City","IL","US","Voluntary: Firm Initiated","Letter","Distributed in the states of AR, MS, SC, and TN.","Z-1193-2013","Class I","Presource PBDS, Gyn Laparoscopy Kit, Circulator","Catalog Number: PB24LSNPC01; Lots: 152737, 159630, 168459, 176674, 187217, 197319, 840618 ",".","4,571 Kits total","Various Presource Kits contain a pre-assembled Filter and Anesthesia Circuit that may contain outer plastic packaging on one or more components. If the packaging is removed without disassembling the components, remnants of the plastic from the packaging material may become lodged in the filter potentially causing an obstruction of airflow.",3/26/2013,"03/26/2013",5/15/2013,"05/15/2013"
"Devices",64736,"Ongoing","Cardinal Health, Medical Products & Services","Park City","IL","US","Voluntary: Firm Initiated","Letter","Distributed in the states of AR, MS, SC, and TN.","Z-1206-2013","Class I","Presource PBDS, Knee Arthroscopy, Kit, Circulator","Catalog Number: PO24KAGWE01; Lots: 839276, 851503, 884374, 905171, 930617, 946381, 952446, 959782",".","4,571 Kits total","Various Presource Kits contain a pre-assembled Filter and Anesthesia Circuit that may contain outer plastic packaging on one or more components. If the packaging is removed without disassembling the components, remnants of the plastic from the packaging material may become lodged in the filter potentially causing an obstruction of airflow.",3/26/2013,"03/26/2013",5/15/2013,"05/15/2013"
"Devices",64736,"Ongoing","Cardinal Health, Medical Products & Services","Park City","IL","US","Voluntary: Firm Initiated","Letter","Distributed in the states of AR, MS, SC, and TN.","Z-1203-2013","Class I","Presource PBDS, Total Joint, Kit, Circulator","Catalog Number: PO24TJNPC01; Lots: 843134, 851291, 875033, 893475, 911751, 914529, 928726, 948543, 968125,",".","4,571 Kits total","Various Presource Kits contain a pre-assembled Filter and Anesthesia Circuit that may contain outer plastic packaging on one or more components. If the packaging is removed without disassembling the components, remnants of the plastic from the packaging material may become lodged in the filter potentially causing an obstruction of airflow.",3/26/2013,"03/26/2013",5/15/2013,"05/15/2013"
"Devices",64736,"Ongoing","Cardinal Health, Medical Products & Services","Park City","IL","US","Voluntary: Firm Initiated","Letter","Distributed in the states of AR, MS, SC, and TN.","Z-1204-2013","Class I","Presource PBDS, Total Knee, Kit, Circulator","Catalog Number: PO24TKGWE01; Lots: 828654, 851596, 872322, 879459, 885132, 905305, 920462, 934298, 946652, 959208 ",".","4,571 Kits total","Various Presource Kits contain a pre-assembled Filter and Anesthesia Circuit that may contain outer plastic packaging on one or more components. If the packaging is removed without disassembling the components, remnants of the plastic from the packaging material may become lodged in the filter potentially causing an obstruction of airflow.",3/26/2013,"03/26/2013",5/15/2013,"05/15/2013"
"Devices",64736,"Ongoing","Cardinal Health, Medical Products & Services","Park City","IL","US","Voluntary: Firm Initiated","Letter","Distributed in the states of AR, MS, SC, and TN.","Z-1196-2013","Class I","Presource PBDS, Major Abdominal, Kit, Circulator","Catalog Number: PG24MANPC01; Lots: 840143, 857320, 871000, 882315, 900599, 928133, 942238, 952387, 964048 ",".","4,571 Kits total","Various Presource Kits contain a pre-assembled Filter and Anesthesia Circuit that may contain outer plastic packaging on one or more components. If the packaging is removed without disassembling the components, remnants of the plastic from the packaging material may become lodged in the filter potentially causing an obstruction of airflow.",3/26/2013,"03/26/2013",5/15/2013,"05/15/2013"
"Devices",64737,"Ongoing","Siemens Medical Solutions USA, Inc","Malvern","PA","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution - USA including the states of AL, CA, CO, DC, DE, FL, GA, HI, IL, IN, KS, KY, LA, MA, MD, MO, NC, NE, NH, NJ, NV, NY, OH, OR, PA, TN, TX, VA, WI, WV, and WY. and the countries of Canada and Australia.","Z-1105-2013","Class II","Siemens syngo WorkFlow SLR, Radiological Information System, Version VA31A SP1/SP2/SP3 The information system syngo(R) Workflow SLR is a digital radiology information system (RIS) with integrated modules for patient administration, examination, reporting, statistics and system administration, as well as multiple interfaces for patient registration, order entry, and external billing modules. It is not intended to treat disease or administer any medicinal substances or drugs. There is no contact between device and patient. syngo(R) Workflow SLR can be used as a separate RIS, interfacing to a Hospital Information System (HIS) or Picture Archiving and Communication Systems (PACS","Model numbers 10558922, 10558933 and 10558980 with software version VA31A SP1/SP2/SP3 ",".","37","Under certain conditions, when using the Search functionality, the potential exists for the wrong patient's Interactive Documents to display when viewing a signed report in the single patient view. This can occur when the Interactive Document is viewed or auto displayed, dismissed by the user, and then a different patient and signed exam is selected in single patient view. The Notes Viewer will display Interactive Document notes for the previously selected patient. The problem is when a signed report is selected, the internal list of selected exams is not being reset. The potential for a safety issue occurs when the Radiologist selects a signed report for a patient and then selects a signed report for a different patient. If the Radiologist is performing an addend on the second signed report and bases the addend on information from the incorrect note, this could then contribute to an incorrect diagnosis if this is not recognized by the Radiologist. Furthermore, if the Radiologist creates and saves a new note, the note could be saved against the previously selected patient.",10/5/2012,"10/05/2012",4/24/2013,"04/24/2013"
"Food",64738,"Ongoing","Publix Super Markets, Inc.","Lakeland","FL","US","Voluntary: Firm Initiated","E-Mail","AL, FL, GA, SC, and TN","F-1315-2013","Class I","Publix Deli Tri Fruit and Grain Salad with red rice, red wheat, quinoa, apricots, cranberry and raisins 12oz. In a clear plastic container.","Item code 04459, UPC Code: 041415396623 Use by dates of 04/15/2013, 04/14/2013 and 04/17/2013",".","772","Product may be adulterated with Listeria monocytogenes.",3/26/2013,"03/26/2013",4/24/2013,"04/24/2013"
"Devices",64739,"Ongoing","Ortho-Clinical Diagnostics","Rochester","NY","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution- USA (nationwided) and countries of: Australia, Brazil, Canada, Chile, Chao Yang District, Beijing, Columbia, England, France, Germany, India, Italy, Japan, Mexico, Republic of Panama, Singapore, Spain and Venezuela.","Z-1161-2013","Class III","VITROS Immunodiagnostic Products Anti-HBs (total antibody to hepatitis B surface antigen (anti-HBs)) Reagent Packs For the quantitative in vitro determination of total antibody to hepatitis B surface antigen (anti-HBs) in human serum. ","Lot #'s 6630 expiration 2/26/2013, Lot # 6740 expiration 6/18/2013 and Lot # 6750 expiration date 6/11/2013. ",".","1464 units","Ortho Clinical Diagnostics is recalling certain lots of the Vitros Anti-HBs Reagent packs an inability to obtain a valid calibration. ",11/1/2012,"11/01/2012",5/1/2013,"05/01/2013"
"Biologics",64741,"Terminated","Ortho Clinical Diagnostics Inc","Raritan","NJ","US","Voluntary: Firm Initiated","Letter","Multiple U.S. States","B-1431-13","Class III","Rho(D) Immune Globulin (Human)","RVP166A1, RVP167A1, RVP164A1",".","3","Rh Immune Globulin, lacking assurance of proper temperature maintenance during transit, was distributed. ",2/22/2013,"02/22/2013",5/15/2013,"05/15/2013"
"Biologics",64742,"Terminated","LifeShare Blood Centers","Monroe","LA","US","Voluntary: Firm Initiated","Letter","Texas","B-1781-13","Class II","Red Blood Cells Leukocytes Reduced","W036512134905",".","1 unit","Blood product, collected from a donor who visited a malarial endemic region, was distributed. ",3/13/2013,"03/13/2013",6/19/2013,"06/19/2013"
"Biologics",64743,"Terminated","Central Pennsylvania Blood Bank","Hummelstown","PA","US","Voluntary: Firm Initiated","Telephone","Pennsylvania","B-1517-13","Class II","Platelets Pooled Leukocytes Reduced","W270112233556",,"1 unit","Blood product, which was not quarantined after the donor provided information concerning a post-donation illness, was distributed.",10/23/2012,"10/23/2012",6/26/2013,"06/26/2013"
"Biologics",64744,"Terminated","Interstate Blood Bank, Inc. of Wisconsin","Milwaukee","WI","US","Voluntary: Firm Initiated","E-Mail","Tennessee","B-1518-13","Class II","Source Plasma","12MKEB3730",,"1 unit","Blood product, collected from a donor whose scheduled physical examination was incomplete, was distributed.",2/26/2013,"02/26/2013",7/3/2013,"07/03/2013"
"Biologics",64745,"Terminated","Central Blood Bank","Pittsburgh","PA","US","Voluntary: Firm Initiated","Telephone","Pennsylvania","B-1585-13","Class III","Red Blood Cells (Apheresis)","W085913000399; W085913000006; W084613000079; W085913000381; W085912005583; W087112001622; ",,"6","Blood products, which did not meet the acceptable product specifications, were distributed.",2/6/2013,"02/06/2013",6/26/2013,"06/26/2013"
"Biologics",64746,"Terminated","LifeSource","Rosemont","IL","US","Voluntary: Firm Initiated","Telephone","Pennsylvania","B-1586-13","Class II","Platelets","W286813054137; ",,"1","Blood product, collected from a donor who was previously deferred, was distributed.",1/29/2013,"01/29/2013",6/26/2013,"06/26/2013"
"Devices",64747,"Ongoing","Edwards Lifesciences, LLC","Draper","UT","US","Voluntary: Firm Initiated","Letter","Nationwide Distribution-USA (nationwide) including DC and the states of AL, AR, AZ, CA, CO, CT, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, ME, MD, MI, MN, MO, MS, NC, ND, NE, NH, NJ, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, WA, and WI.","Z-1134-2013","Class II","Edwards Lifesciences Crimpers, Model 9100CR23. The Crimpers are used to crimp the transcatheter heart valve onto the delivery system prior to use. ","Models 9100CR23, all lot numbers.",".","5,472 units","Holes in the sterile barrier pouch may be caused by handling of the device during manufacturing or once pouches have been removed from the unit box and stored on the shelf by customers.",3/26/2013,"03/26/2013",4/24/2013,"04/24/2013"
"Devices",64747,"Ongoing","Edwards Lifesciences, LLC","Draper","UT","US","Voluntary: Firm Initiated","Letter","Nationwide Distribution-USA (nationwide) including DC and the states of AL, AR, AZ, CA, CO, CT, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, ME, MD, MI, MN, MO, MS, NC, ND, NE, NH, NJ, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, WA, and WI.","Z-1135-2013","Class II","Edwards Lifesciences Crimpers, Model 9100CR26. The Crimpers are used to crimp the transcatheter heart valve onto the delivery system prior to use. ","Models 9100CR26, all lot numbers.",".","6,117 units","Holes in the sterile barrier pouch may be caused by handling of the device during manufacturing or once pouches have been removed from the unit box and stored on the shelf by customers.",3/26/2013,"03/26/2013",4/24/2013,"04/24/2013"
"Devices",64748,"Completed","GE Healthcare, LLC","Waukesha","WI","US","Voluntary: Firm Initiated","Visit","Worldwide Distribution -- USA, including all states except ME, and the U.S. Virgin Islands; and, the countries of AUSTRALIA, AUSTRIA, BELGIUM, CANADA, CHILE, CHINA, CZECH REPUBLIC, DENMARK, ESTONIA, FINLAND, FRANCE, GERMANY, GREECE, INDIA, IRELAND, ISRAEL, ITALY, JAPAN, KOREA, KUWAIT, MALAYSIA, NETHERLAND, NEW ZEALAND, NORWAY, PHILIPPINES,S QATAR, SAUDI ARABIA, SINGAPORE, SOUTH AFRICA SPAIN, SWEDEN, SWITZERLAND, TAIWAN, TURKEY, UNITED ARAB EMIRATES, and UNITED KINGDOM.","Z-1133-2013","Class II","GE Healthcare Muse v7 cardiology information system. Model number 2026443-001: MUSE 7.0 app cd, Model Number 2026443-015: MUSE 7.0.2 app cd, Model number 2026443-017: MUSE 7.1 app cd, Model number 2026443-029:MUSE 7.1.1 A app cd, and Model Number 2026443-031: MUSE 7.1.1 app cd. Intended to store, access and manage cardiovascular information on adult and pediatrics patients.","Serial Number SBP05450003GA SBP05450009GA SBP05500067GA SBP06100195GA SBP06110200GA SBP06110203GA SBP06160274GA SBP06170288GA SBP06180296GA SBP06180306GA SBP06180308GA SBP06190316GA SBP06190326GA SBP06190329GA SBP06190330GA SBP06200371GA SBP06200377GA SBP06230507GA SBP06230512GA SBP06250577GA SBP06260614GA SBP06260619GA SBP06280624GA SBP06280626GA SBP06280629GA SBP06280637GA SBP06280653GA SBP06290744GA SBP06290748GA SBP06290758GA SBP06290768GA SBP06300778GA SBP06300789GA SBP06310812GA SBP06310814GA SBP06330820GA SBP06330824GA SBP06330838GA SBP06330841GA SBP06330853GA SBP06330873GA SBP06330878GA SBP06340958GA SBP06340959GA SBP06360974GA SBP06360979GA SBP06360983GA SBP06361019GA SBP06371040GA SBP06371055GA SBP06371058GA SBP06371061GA SBP06391095GA SBP06391100GA SBP06411137GA SBP06411147GA SBP06421164GA SBP06421167GA SBP06421169GA SBP06421171GA SBP06421183GA SBP06421189GA SBP06431228GA SBP06441246GA SBP06441251GA SBP06441277GA SBP06441279GA SBP06441282GA SBP06441296GA SBP06441306GA SBP06441312GA SBP06441319GA SBP06451321GA SBP06451335GA SBP06451337GA SBP06451340GA SBP06481394GA SBP06481398GA SBP06481421GA SBP06491463GA SBP06491466GA SBP06491469GA SBP06491472GA SBP06501503GA SBP06501507GA SBP06511545GA SBP06511569GA SBP06511571GA SBP06511579GA SBP06511615GA SBP06511621GA SBP06521635GA SBP06521648GA SBP06521689GA SBP06521693GA SBP06521694GA SBP06521708GA SBP06521710GA SBP06521711GA SBP07021747GA SBP07021755GA SBP07041777GA SBP07041783GA SBP07041791GA SBP07051813GA SBP07061846GA SBP07061860GA SBP07061871GA SBP07061877GA SBP07061887GA SBP07061892GA SBP07061929GA SBP07071968GA SBP07081995GA SBP07082002GA SBP07092008GA SBP07092009GA SBP07102056GA SBP07122076GA SBP07122079GA SBP07122131GA SBP07122134GA SBP07122137GA SBP07122144GA SBP07122148GA SBP07132155GA SBP07142179GA SBP07142194GA SBP07142196GA SBP07142197GA SBP07152207GA SBP07152209GA SBP07152212GA SBP07152226GA SBP07152230GA SBP07152233GA SBP07152238GA SBP07162252GA SBP07182285GA SBP07182291GA SBP07182294GA SBP07192309GA SBP07192310GA SBP07192314GA SBP07192324GA S",".","963","GE Healthcare conducted a recall on the Muse v7 because incorrect medications were displayed on the MUSE, which could result in incorrect treatment.",1/4/2012,"01/04/2012",4/24/2013,"04/24/2013"
"Devices",64749,"Ongoing","Ormco/Sybronendo","Glendora","CA","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution - USA (nationwide) including the country of EU.","Z-1084-2013","Class II","Bracket Buccal Tube U7L DB/UL22 Roth MT HK 0/-14/0 Product Usage: Bracket Buccal Tubes are intended to hold in orthodontic wires used to move teeth during orthodontic treatment ","Part Number 438-0184 Lot Number 051063597 ",,"8210","Ormco Corporation is voluntarily recalling one (1) lot of Bracket Buccal Tubes as a result of a packaging error. More specifically, the BracketBuccal Tubes product package correctly identifies the product as gingival (0) offset brackets, but actually contains distal (10) offset brackets. Use of the affected product may cause unintended rotation of the molars. Although reversible, a delay in treatment could occur.",3/8/2013,"03/08/2013",4/17/2013,"04/17/2013"
"Food",64750,"Ongoing","NatureBox, Inc.","San Carlos","CA","US","Voluntary: Firm Initiated","Letter","Internet sales only.","F-1295-2013","Class II","NatureBox brand Umami Almonds packed in branded stand-up pouches (whole tamari flavored almonds), Net wt. 4.3 oz. No UPC Codes on the product, Product is processed and packaged by NatureBox, San Carlos, CA; NOTE: Product label DOES declare that it is ''Packed in a facility that also processes tree nuts, peanuts, milk, wheat, and soy'' below the ingredient statement. ","All lot codes with Best By Dates or 5/15/13 or earlier.",,"802","Product may contain wheat allergen. Wheat is not listed in the ingredient statement. ",3/27/2013,"03/27/2013",4/17/2013,"04/17/2013"
"Devices",64751,"Completed","Engineered Medical Systems,Inc","Indianapolis","IN","US","Voluntary: Firm Initiated","Letter","Distributed in the states of PA, IN, NY, CO, and CA.","Z-1058-2013","Class I","Respironics SealFlex Single Port Ribbed Mask (Infant). For general use in respiratory and anesthesia applications as a conduit for various gases to resuscitate or to enhance breathing abilities of the patient. .","REF 8-205508-00Lot Number: 820550800110419. ",,"1500pcs, 75cs {20pcs per cases)","The mask inside the package has been identified as ''Neonatal'' in size and not ''Infant'' as the labeling indicates.",9/12/2011,"09/12/2011",4/17/2013,"04/17/2013"
"Biologics",64752,"Terminated","HCSC-Blood Center","Bethlehem","PA","US","Voluntary: Firm Initiated","Letter","Pennsylvania; Korea, Republic Of(South)","B-1587-13","Class II","Platelets Pheresis Leukocytes Reduced Irradiated","W050912104904; ",,"1","Blood products, collected from donors for whom donor suitability was not adequately determined, were distributed.",2/22/2013,"02/22/2013",6/26/2013,"06/26/2013"
"Biologics",64752,"Terminated","HCSC-Blood Center","Bethlehem","PA","US","Voluntary: Firm Initiated","Letter","Pennsylvania; Korea, Republic Of(South)","B-1590-13","Class II","Red Blood Cells Leukocytes Reduced","W050912006986; ",,"1","Blood products, collected from donors for whom donor suitability was not adequately determined, were distributed.",2/22/2013,"02/22/2013",6/26/2013,"06/26/2013"
"Biologics",64752,"Terminated","HCSC-Blood Center","Bethlehem","PA","US","Voluntary: Firm Initiated","Letter","Pennsylvania; Korea, Republic Of(South)","B-1588-13","Class II","Red Blood Cells Leukocytes Reduced Irradiated","W050912007007; ",,"1","Blood products, collected from donors for whom donor suitability was not adequately determined, were distributed.",2/22/2013,"02/22/2013",6/26/2013,"06/26/2013"
"Biologics",64752,"Terminated","HCSC-Blood Center","Bethlehem","PA","US","Voluntary: Firm Initiated","Letter","Pennsylvania; Korea, Republic Of(South)","B-1589-13","Class III","Recovered Plasma","W050912007007; ",,"1","Blood products, collected from donors for whom donor suitability was not adequately determined, were distributed.",2/22/2013,"02/22/2013",6/26/2013,"06/26/2013"
"Biologics",64752,"Terminated","HCSC-Blood Center","Bethlehem","PA","US","Voluntary: Firm Initiated","Letter","Pennsylvania; Korea, Republic Of(South)","B-1591-13","Class II","Fresh Frozen Plasma","W050912006986; ",,"1","Blood products, collected from donors for whom donor suitability was not adequately determined, were distributed.",2/22/2013,"02/22/2013",6/26/2013,"06/26/2013"
"Drugs",64753,"Ongoing","West-ward Pharmaceutical Corp.","Eatontown","NJ","US","Voluntary: Firm Initiated","Letter","Nationwide","D-306-2013","Class II","Donnatal Extentabs, 0.3888mg/46.8mg, 100-count bottle (NDC # 66213-421-10), Rx only Manufactured By: West-ward Pharmaceutical, 435 Industrial Way West, Eatontown, NJ 07724 Manufactured For: PBM Pharmaceuticals, Inc. Gordonsville, VA 22942. ","Lot # 68864; exp 04/13",,"1,258 bottles","Labeling: Incorrect or Missing Lot and/or Exp Date: Bottled product is labeled with an expiration date of Apr 2015. The correct expiration is Apr 2013. ",2/25/2013,"02/25/2013",5/8/2013,"05/08/2013"
"Devices",64754,"Ongoing","Medtronic MiniMed","Northridge","CA","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution - USA (nationwide) the countries of: AE, AR, AT, AU, BA, BH, BM, BR, BS, CA, CH, CL, CN, CO, CR, CY, CZ, DE, DK, DO, DZ, EC, EE, EG, ES, FI, FR, GB, GR, GT, HK, HR, HU, IE, IL, IN, IQ, IT, JO, JP, KR, KW, LB, LC, LV, MK, MX, MY, NL, NO, NZ, OM, PA, PE, PL, PR, PY, QA, RO, SA, SE, SG, SI, SK, SV, SY, TF, TH, TR, TT, TW, UA, UY, VE, ZA.","Z-1085-2013","Class II","Medtronic MiniMed Paradigm Insulin Infusion Pumps Model Numbers: MMT-511, MMT-512, MMT-712, MMT-712E, MMT-515, MMT-715, MMT-522, MMT-522K, MMT-722, MMT-722K, MMT-523, MMT-523K, MMT-723, MMT-723K, MMT-554, and MMT-754. Product Usage: Paradigm insulin infusion pumps are intended for use to deliver basal and bolus insulin to persons with diabetes. ","Not available",,"428,000 units","Medtronic is recalling the Medtronic Paradigm Insulin Pump because the pump's drive support cap may become detached from the pump case and protrude from the lower right side of the pump. When the pump is expose to water it may result in damage to the pump's internal electronics. This moisture damage can prevent the pump's buttons from working properly or can cause the pump to alarm.",3/22/2013,"03/22/2013",4/17/2013,"04/17/2013"
"Devices",64755,"Ongoing","Intuitive Surgical, Inc.","Sunnyvale","CA","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution.-USA (nationwide) and countries of: Austria, Belgium, Denmark, Finland, France, Germany, Ireland, Netherlands, Norway, South Korea, Sweden, Switzerland, and United Kingdom.","Z-1110-2013","Class II","IS3000 USER MANUAL for Intuitive Surgical da Vinci Si Surgical System and da Vinci Si-e Surgical System, Model SI3000. Arm drapes protect equipment from contamination. ","Model number 550650-05 (P8)",".","1642 customers","Revised instructions for users of the da Vinci S, Si and Si-e systems with additional information regarding sterile adapter engagement and instrument installation.",3/15/2013,"03/15/2013",4/24/2013,"04/24/2013"
"Devices",64755,"Ongoing","Intuitive Surgical, Inc.","Sunnyvale","CA","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution.-USA (nationwide) and countries of: Austria, Belgium, Denmark, Finland, France, Germany, Ireland, Netherlands, Norway, South Korea, Sweden, Switzerland, and United Kingdom.","Z-1109-2013","Class II","IS2000 USER MANUAL for Intuitive Surgical da Vinci S Surgical System, Model IS2000. Arm drapes protect equipment from contamination. ","Model number 550516-05",".","1642 customers","Revised instructions for users of the da Vinci S, Si and Si-e systems with additional information regarding sterile adapter engagement and instrument installation.",3/15/2013,"03/15/2013",4/24/2013,"04/24/2013"
"Food",64756,"Terminated","New Seasons Market","Portland","OR","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Distributed in Oregon and Washington","F-1296-2013","Class II","Product does not have a label. The consignees are provided with an ingredient statement for all the products they purchase. The product is packaged in a reusable plastic tote, with white sticker applied to one side of tote. This sticker has the Prepared Date: which is hand written as the month-day.","3/19/2013 through 3/27/2013",,"14 containers of 144 each","There is the possibility of what appears to be plastic/paint shavings in the container holding the raw cookie product.",3/27/2013,"03/27/2013",4/17/2013,"04/17/2013"
"Veterinary",64757,"Ongoing","Abbott Animal Health","Abbott Park","IL","US","Voluntary: Firm Initiated","Telephone","Nationwide (CA, GA, IA, IN, KY, MN, OR, TX, VA, WA)","V-195-2013","Class III","Isoflo; Isoflurane, USP; Nonflammable, Nonexplosive; Inhalation Anesthetic; 250 mL; For Use in Horses and Dogs; packaged in amber bottles; Product expires 8/23/14","Product Code: 5260-13-05; Lot: 24-002E",".","5,898 cases (35,388 bottles)","Canadian labeled Isoflurane was shipped to US customers.",3/15/2013,"03/15/2013",5/29/2013,"05/29/2013"
"Devices",64759,"Completed","GE Healthcare, LLC","Waukesha","WI","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution - USA (nationwide) including the states of: AR, CA, GA, IL, IN,IA,LA, MA, MN, MT, NY, OH, PA, TX, VA and the countries of BELGIUM, BURKINA FASO, BRAZIL, CHINA, CANADA, SWITZERLAND, CHILE, COLOMBIA, CYPRUS, CZECH REPUBLIC, GERMANY, DENMARK, DOMINICAN REPUBLIC, EGYPT, SPAIN, FRANCE, UNITED KINGDOM, CHANA, GUADELOUPE, GREECE, GUYANA, HONG KONG, CROATIA, HUNGARY, INDONESIA, ISRAEL, ITALY, KUWAIT, LEBANON LUXEMBURG, LIBYAN, MOROCCO, MARTINIQUE, MEXICO, NETHERLANDS, NORWAY, PANAMA, PERU, POLAND, PORTUGAL , REUNION, ROMANIA, RUSSIAN FEDERATION, SAUDI ARABIA, SUDAN, SWEDEN, SINGAPORE, SLOVENIA, SLOVAKIA, SIERRA LEONE, THAILAND, TUNISIA, TURKEY, VENEZUELA, MACEDONIA, PALESTINE, SOUTH AFRICA.","Z-1083-2013","Class II","VMX, VMX Plus Mobile Radiographic Unit with the following models:45296139; 45296200; 45296350; 45296477; 45296964; 45297001; 45296966; 45297003; 2240169; 2240171; 2240172; 2240173. Product Usage: The VMX is a mobile radiography system incorporating stylish design for totally adapted use in intensive care, emergencies, pediatrics, neonatology and orthopedics.","00000155075MO5 00000006136YY6 00000006802YY3 00000006799YY1 00000007989YY7 00000007990YY5 00000002358YY0 00000021131YY8 00000021132YY6 00000021146YY6 00000021139YY1 00000021141YY7 00000021159YY9 00000041750YY1 00000021108YY6 00000041725YY3 00000041778YY2 00000083296YY4 00000085032YY1 00000118252MO6 00000085956YY1 00000160478MO4 00000021116YY9 00000021017YY9 00000011088YY2 00000024550YY6 00000021097YY1 00000031512YY7 00000031585YY3 00000025793YY1 00000002355YY6 00000006148YY1 00000147625MO8 00000021024YY5 00000021134YY2 00000021140YY9 00000024543YY1 00000021103YY7 00000021107YY8 00000021151YY6 00000041762YY6 00000041772YY5 00000041768YY3 00000041766YY7 00000041764YY2 00000041771YY7 00000041770YY9 00000041784YY0 00000041783YY2 00000083295YY6 00000140455MO7 00000140451MO6 00000086024YY7 00000086043YY7 00000086036YY1 00000086025YY4 00000086046YY0 00000086048YY6 00000140453MO2 00000086049YY4 00000086032YY0 00000086026YY2 00000086033YY8 00000140467MO2 00000140473MO0 00000140459MO9 00000140464MO9 00000140460MO7 00000140471MO4 00000160470MO1 00000008077YY0 00000083292YY3 00000059632YY1 00000006796YY7 00000006804YY9 00000021157YY3 00000021158YY1 00000041780YY8 00000086001YY5 00000086016YY3 00000086017YY1 00000140487MO0 00000021051YY8 00000155065MO6 00000085037YY0 00000085031YY3 00000084999YY2 00000106771MO9 00059632YY70CS 00000140535MO6 00059632YY71CS 00000005327YY2 00000013802YY4 00000024542YY3 00000024564YY7 00000031588YY7 00000048207YY5 00000048221YY6 00000048220YY8 00000059601YY5 00000083261YY8 00000085043YY8 00000085060YY2 00000085081YY8 00000085080YY0 00000089505MO2 00106782MO35CS 00000089509MO4 00000089520MO1 00000089522MO7 00000089532MO6 00106782MO37CS 00000089547MO4 00000106753MO7 00000118276MO5 00000118277MO3 00000118279MO9 00000118278MO1 00000140525MO7 00059632YY72CS 00000140526MO5 00000140546MO3 00000147624MO1 00000106778MO4 00000106780MO0 00000155024MO3 00000041752YY7 00000025765YY9 00000059632YY3 00000048275YY2 00000106782MO8 00000106769MO3 00000155057MO3 00000010905YY8 00000011006YY4 00000013795YY0 00000",,"1296","GE Healthcare has become aware of an issue associated with the base casting for the articulated arm of your VMX andVMX Plus Mobile X-ray systems that may impact Operator or Patient safety.",1/23/2012,"01/23/2012",4/17/2013,"04/17/2013"
"Devices",64762,"Ongoing","Ge Healthcare It","Barrington","IL","US","Voluntary: Firm Initiated","Letter","US Distribution incluidng states of: CA, FL, GA, IA, IL, LA, MO, NJ, NY, OK, TN, WA, and WI.","Z-0454-2014","Class II","The GE Centricity Web; Software Version 3.0x, is intended for use under the direct supervision of a licensed healthcare practitioner. The Centricity Enterprise Web is an image and information distribution system for the clinical review of medical images and reports. The Centricity Enterprise Web is not intended for primary diagnosis. The Centricity Enterprise Web is available as a supplemental sub-system to Centricity PACS or as a stand alone Web-based image and information distribution system. The Centricity Enterprise Web provides both the server software and a client application, which utilizes off the shelf browser technology. Centricity Enterprise Web supports several interface protocols which allows the system to be integrated with any image or information systems such as a hospital information system (HIS), radiology information system (RIS), or electronic medical record (EMR), which supports one of the supported integration protocols. ","Software versions: 3.0.x",".","53 units","GE Healthcare has become aware of an issue associated with rejected images using the WADO protocol within GE Centricity Web that may impact patient safety. The WADO (Web Access to DICOM Objects) interface allows for embedding DICOM images as JPEGs on a web page and is available as a licensed operation on Centricity Web. When rejected images are archived by Centricity PACS to Enterprise Archive, and the WADO protocol is used to retrieve images via Centricity Web from the Enterprise Archive, all images in the exam are returned, including any rejected images. These rejected images are not identifiable as such. A rejected image may result in a misdiagnosis.",4/19/2012,"04/19/2012",12/11/2013,"12/11/2013"
"Devices",64763,"Completed","GE Healthcare, LLC","Waukesha","WI","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution - USA (nationwide) including the states of: AZ, CA, CO, FL, IL, MD, NJ, NY, OH, OK, TX. and the countries of Australia, Belarus, Canada,France, Germany, India, Japan, Lebanon, New Zealand, Saudi Arabia, Singapore, Spain, Sweden, Switzerland and United Kingdom.","Z-1100-2013","Class II","GE Healthcare, Discovery MR750w 3.0T System. Part Number: 5352293. Product Usage: It is indicated for use as a diagnostic imaging device to produce axial, sagittal, coronal, and oblique images, spectroscopic images, parametric maps, and/or spectra,dynamic images of the structures and/or functions of the entire body, including, but not limited to, head, neck, TMJ, spine, breast, heart, abdomen, pelvis, joints, prostate,blood vessels, and musculoskeletal regions of the body. ","Serial Number00000000UA0027 00000000UA0012 00000000UA0029 00000000UA0031 00000000UA0030 00000000UA0028 00000000UA0034 00000000UA0038 00000000UA0048 00000000UA0046 00000000UA0052 00000000UA0041 00000000UA0011A 00000000UA0055 00000000UA0056 00000000UA0057 00000000UA0064 00000000UA0053 00000000UA0044 00000000UA0047 00000000UA0010 00000000UA0013 00000000UA0017 00000000UA0042 00000000UA0016 00000000UA0019 00000000UA0015 00000000UA0058 00000000UA0051 00000000UA0025 00000000UA0024 00000000UA0020 00000000UA0040 00000000UA0018 00000000UA0036 00000000UA0043 00000000UA0054 00000000UA0022 00000000UA0023 00000000UA0045 00000000UA0039 00000000UA0035 00000000UA0049 00000000UA0021 00000000UA0033 00000000UA0037 ",,"46","GE Healthcare has recently become aware of a potential issue due to image flip in frequency encoding direction associated with a specific workflow of your Discovery MR750w system.Image flip issue in frequency encoding direction (including S/I, A/P and R/L) can result in incorrect localization of anatomy and pathological findings.",4/23/2012,"04/23/2012",4/17/2013,"04/17/2013"
"Food",64764,"Terminated","Ancient Formulas Inc","Wichita","KS","US","Voluntary: Firm Initiated","Telephone","The bulk tablets were distributed to MO where they were repackaged into bottles. There was no foreign/military/government distribution.","F-1802-2013","Class II","Bulk tablet label: Keytabs W.O. Glandulars (pink) ","Lot 103-0313",,"51,000 bulk tablets","Product contains higher levels of niacin than claimed on label .",3/22/2013,"03/22/2013",8/21/2013,"08/21/2013"
"Food",64764,"Terminated","Ancient Formulas Inc","Wichita","KS","US","Voluntary: Firm Initiated","Telephone","The bulk tablets were distributed to MO where they were repackaged into bottles. There was no foreign/military/government distribution.","F-1803-2013","Class II","KEYTABS (Without Iron, Copper or Glandulars), packaged in 180-tablet bottles, a product of The Key Company, St. Louis, MO.","Lot YDBI, Exp. 03/2016",,"124/180-tablet bottles","Product contains higher levels of niacin than claimed on label .",3/22/2013,"03/22/2013",8/21/2013,"08/21/2013"
"Biologics",64765,"Terminated","LifeSouth Community Blood Centers Inc","Madison","AL","US","Voluntary: Firm Initiated","FAX","Alabama","B-1592-13","Class II","Platelets Pheresis Leukocytes Reduced","W115113019228O; ",,"1","Blood product, for which the quality control testing was incomplete and not documented , was distributed.",3/11/2013,"03/11/2013",6/26/2013,"06/26/2013"
"Biologics",64766,"Terminated","Community Blood Centers of Florida, Inc.","Miami","FL","US","Voluntary: Firm Initiated","Telephone","Cayman Islands; Florida","B-1593-13","Class II","Red Blood Cells","W036812596437; ",,"1","Blood products, which were collected from a donor in which donor suitability was not adequately determined, were distributed.",3/22/2013,"03/22/2013",6/26/2013,"06/26/2013"
"Biologics",64766,"Terminated","Community Blood Centers of Florida, Inc.","Miami","FL","US","Voluntary: Firm Initiated","Telephone","Cayman Islands; Florida","B-1595-13","Class III","Blood and Blood Products for Reprocessing","W036812596437; ",,"1","Blood products, which were collected from a donor in which donor suitability was not adequately determined, were distributed.",3/22/2013,"03/22/2013",6/26/2013,"06/26/2013"
"Biologics",64766,"Terminated","Community Blood Centers of Florida, Inc.","Miami","FL","US","Voluntary: Firm Initiated","Telephone","Cayman Islands; Florida","B-1594-13","Class II","Platelets Pooled Leukocytes Reduced","W036812849275; ",,"1","Blood products, which were collected from a donor in which donor suitability was not adequately determined, were distributed.",3/22/2013,"03/22/2013",6/26/2013,"06/26/2013"
"Biologics",64767,"Terminated","North Carolina Eye Bank, Inc. (The)","Winston Salem","NC","US","Voluntary: Firm Initiated","Telephone","Texas","B-1432-13","Class II","Cornea","04871302",".","1 Cornea","Human corneal allograft was processed in a manner that could cause contamination or cross-contamination during processing, and well as the introduction, transmission, or spread of communicable disease through the use of the HCT/P. ",3/11/2013,"03/11/2013",5/15/2013,"05/15/2013"
"Biologics",64768,"Terminated","Mississippi Valley Reg Bld Ctr","Davenport","IA","US","Voluntary: Firm Initiated","Telephone","New York","B-1596-13","Class II","Platelets Pheresis Leukocytes Reduced","W039513004936; ",,"1","Blood product, which did not meet acceptable product specifications, was distributed.",2/21/2013,"02/21/2013",6/26/2013,"06/26/2013"
"Biologics",64769,"Terminated","Lifesouth Community Blood Centers - Montgomery Region","Montgomery","AL","US","Voluntary: Firm Initiated","FAX","Alabama","B-1597-13","Class II","Fresh Frozen Plasma","W115113021564E; ",,"1","Blood product, which did not meet required specifications, was distributed.",1/21/2013,"01/21/2013",6/26/2013,"06/26/2013"
"Devices",64770,"Ongoing","Transonic Systems Inc","Ithaca","NY","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution - USA Nationwide including the states of AZ, CA, FL, GA, NM, NY, TX, VA and WA and countries of Netherlands, Canada and Russia.","Z-1147-2013","Class II","HCS3011 AV Loop Kit For use with Transonic CO status System Only, -HCS3021 AV Loop Kit For use with Transonic CO status System Only. Product Usage: is indicated for use in patients greater than or equal to 2 years old with arterial and venous lines in the diagnostic assessment of cardiovascular status including cardiac output and associated hemodynamic parameters. ","Lot numbers: 102810, 010311 and 111810. ",".","195 units total (140 units Domestic, 55 units Foreign)","Transonic Systems Inc. have received complaints of blood leakage involving the AV Loop Kit.",3/28/2013,"03/28/2013",4/24/2013,"04/24/2013"
"Devices",64771,"Ongoing","Synthes USA HQ, Inc.","West Chester","PA","US","Voluntary: Firm Initiated","Letter","Nationwide Distribution: USA including states of: IL, IN, MA, MI, MO, NJ, NY, OH, OR, PA, SC, TX, VA, WA and WI","Z-1238-2013","Class II","Synthes Radial Head Prosthesis: Trial Radial Head Elbow joint prosthesis: Synthes Radial Head Prosthesis System is a two-piece modular system comprised of titanium alloy stem and cobalt chrome components with an integral screw and side-loading application to allow in-situ assembly.","All Lots of Part Numbers: 03.402.018, 03.402.020, 03.402.022, 03.402.024, 03.402.026, 03.402.028, 03.402.218, 03.402.220, 03.402.222, 03.402.224, 03.402.226, 03.402.228, 03.402.418, 03.402.420, 03.402.422, 03.402.424, 03.402.426, 03.402.428, 03.402.618, 03.402.620, 03.402.622, 03.402.624, 03.402.626, and 03.402.628.",".","417","The Trial Head may come loose from the implant stem during manipulation of the arm during surgery. To date, no adverse events have been reported related to this issue and this recall is not being initiated as a result of adverse events.",2/22/2013,"02/22/2013",5/15/2013,"05/15/2013"
"Food",64772,"Ongoing","SIB, Inc.","Bloomington","IN","US","Voluntary: Firm Initiated","Telephone","retail grocery stores in Indiana and 1 retail store in Illinois","F-1321-2013","Class II","Bakehouse Granola, 12 oz, 340 g, Scholar's Inn Bakehouse Granola 16 oz, 454 g All Natural, Baked locally","16oz bags: UPC: 635655005249 Best by: 3/9/13 -5/9/13 Lots 1209A, 1209B, 1209AB, 1209BB, 1210A, 1210B, 1210AB, 1210 BB, 108A, 108B, 113A, 113 B, 116A, 116B, 117A, 117B,118A, 118B, 123A, 123B, 124A, 124B, 130A, 203A, 203B, 131A, 131B, 206A, 206B, 207A, 207B, 209A, 209B, and 209C 12 oz bags: UPC 0063565507524, Best by 5/14/13-7/1/13 Lots 213A, 213B, 214A, 214B, 216A, 216B, 217A, 217B, 220B, 221A, 221B, 224B, 226A, 226B, 227A, 227B, 228A, 228B, 307A, 307B, 308A, 313A, 313B, 314A, 314B, 316A, 316B, 320A, 320B, 321A, 321B, 323A, and 323BC",".","10460 bags of both sizes (9342.25 lbs) ","Bake House Granola, does not list the source of the unsalted butter ingredient as milk, an allergen. People who have an allergy or severe sensitivity to milk, run the risk of serious or life-threatening allergic reaction if they consume these products. ",3/25/2013,"03/25/2013",5/1/2013,"05/01/2013"
"Biologics",64773,"Ongoing","Siemens Healthcare Diagnostics Inc.","Berkeley","CA","US","Voluntary: Firm Initiated","Letter","US and Belgium, France, Greece, Italy, Portugal, Spain, Germany, Kenya, Martinique, Austria, Brazil, Canada, Czech Republic, Guadeloupe, Ireland, Israel, Kuwait, Latvia, Mexico, Panama, Peru, Saudi Arabia, Thailand, UK, Uruguay, Vietnam","B-1448-13","Class II","MicroCel 500 Buffer Chamber Distributed by Siemens Healthcare Diagnostics, 725 Potter Street, Berkeley, CA 94710","Catalog number 10312319/VG 42115 ",".","1","MicroCel 500 and MicroCel 300 buffer chambers, with the potential to leak buffer and could cause electrical arcing posing a hazard to the operator, were distributed. ",3/28/2013,"03/28/2013",5/15/2013,"05/15/2013"
"Biologics",64773,"Ongoing","Siemens Healthcare Diagnostics Inc.","Berkeley","CA","US","Voluntary: Firm Initiated","Letter","US and Belgium, France, Greece, Italy, Portugal, Spain, Germany, Kenya, Martinique, Austria, Brazil, Canada, Czech Republic, Guadeloupe, Ireland, Israel, Kuwait, Latvia, Mexico, Panama, Peru, Saudi Arabia, Thailand, UK, Uruguay, Vietnam","B-1449-13","Class II","MicroCel 300 Buffer Chamber Distributed by Siemens Healthcare Diagnostics, 725 Potter Street, Berkeley, CA 94710","Catalog number 10319937/ VG 42044",".","1","MicroCel 500 and MicroCel 300 buffer chambers, with the potential to leak buffer and could cause electrical arcing posing a hazard to the operator, were distributed. ",3/28/2013,"03/28/2013",5/15/2013,"05/15/2013"
"Devices",64776,"Ongoing","Lighthouse For The Blind","Olivette","MO","US","Voluntary: Firm Initiated","E-Mail","Nationwide Distribution including DC and the states of AK, AL, AR, AZ, CA, CO, DE, FL, GA, ID, IL, IN, KS, KY, MI, MD, MN, MO, MT, NC, NJ, NM, NY, NV, OH, OK, PA, SC, TN, TX, UT, VA, WA and WY.","Z-1086-2013","Class III","LHB, Type I First Aid Kit Perishable, Non-Aspirin 4/pg, Aspirin 4/pg and Povidone Iodine, antiseptic towelette. Kit Number: 2113110. First Aid Kit.","All kits shipped between 1/12010 through 3/4/2013. ",,"635 kits","The product contains an iodine 10% Ampule (10% Povidone Iodine swab) which is being recalled by the firm's distributor. The labeling of the iodine 10% Ampule labels state that the contents of the package are sterile and does not clarify that this sterility claim is only applicable to the applicator. The antiseptic solution that is applied to the skin is a cutaneous disinfectant, and is not sterilized. Some product labeling states ''Sterility guaranteed unless seal broken'' or ''Contents sterile if package is intact.'' These claims were intended to indicate surface sterilization only but could mistakenly lead to the conclusion that the drug product solution is sterile. It was determined that labeling on certain products could be misleading in relation to sterility claims. ",3/22/2013,"03/22/2013",4/17/2013,"04/17/2013"
"Devices",64776,"Ongoing","Lighthouse For The Blind","Olivette","MO","US","Voluntary: Firm Initiated","E-Mail","Nationwide Distribution including DC and the states of AK, AL, AR, AZ, CA, CO, DE, FL, GA, ID, IL, IN, KS, KY, MI, MD, MN, MO, MT, NC, NJ, NM, NY, NV, OH, OK, PA, SC, TN, TX, UT, VA, WA and WY.","Z-1090-2013","Class III","LHB, First Aid Type III, NSN # 6545-00-656-1094, Kit number: 2114011. First Aid Kit.","All kits shipped between 1/12010 through 3/4/2013. ",,"41,595 kits","The product contains an iodine 10% Ampule (10% Povidone Iodine swab) which is being recalled by the firm's distributor. The labeling of the iodine 10% Ampule labels state that the contents of the package are sterile and does not clarify that this sterility claim is only applicable to the applicator. The antiseptic solution that is applied to the skin is a cutaneous disinfectant, and is not sterilized. Some product labeling states ''Sterility guaranteed unless seal broken'' or ''Contents sterile if package is intact.'' These claims were intended to indicate surface sterilization only but could mistakenly lead to the conclusion that the drug product solution is sterile. It was determined that labeling on certain products could be misleading in relation to sterility claims. ",3/22/2013,"03/22/2013",4/17/2013,"04/17/2013"
"Devices",64776,"Ongoing","Lighthouse For The Blind","Olivette","MO","US","Voluntary: Firm Initiated","E-Mail","Nationwide Distribution including DC and the states of AK, AL, AR, AZ, CA, CO, DE, FL, GA, ID, IL, IN, KS, KY, MI, MD, MN, MO, MT, NC, NJ, NM, NY, NV, OH, OK, PA, SC, TN, TX, UT, VA, WA and WY.","Z-1092-2013","Class III","LHB, First Aid Type IV Belt Type, NSN #6545-01-010-7754. Kit number: 114016. First Aid Kit.","All kits shipped between 1/12010 through 3/4/2013. ",,"6,075/kits","The product contains an iodine 10% Ampule (10% Povidone Iodine swab) which is being recalled by the firm's distributor. The labeling of the iodine 10% Ampule labels state that the contents of the package are sterile and does not clarify that this sterility claim is only applicable to the applicator. The antiseptic solution that is applied to the skin is a cutaneous disinfectant, and is not sterilized. Some product labeling states ''Sterility guaranteed unless seal broken'' or ''Contents sterile if package is intact.'' These claims were intended to indicate surface sterilization only but could mistakenly lead to the conclusion that the drug product solution is sterile. It was determined that labeling on certain products could be misleading in relation to sterility claims. ",3/22/2013,"03/22/2013",4/17/2013,"04/17/2013"
"Devices",64776,"Ongoing","Lighthouse For The Blind","Olivette","MO","US","Voluntary: Firm Initiated","E-Mail","Nationwide Distribution including DC and the states of AK, AL, AR, AZ, CA, CO, DE, FL, GA, ID, IL, IN, KS, KY, MI, MD, MN, MO, MT, NC, NJ, NM, NY, NV, OH, OK, PA, SC, TN, TX, UT, VA, WA and WY.","Z-1093-2013","Class III","LHB, Perishable Items Pack Type IV. Kit number: 2114016-100. First Aid Kit.","All kits shipped between 1/12010 through 3/4/2013. ",,"425 kits","The product contains an iodine 10% Ampule (10% Povidone Iodine swab) which is being recalled by the firm's distributor. The labeling of the iodine 10% Ampule labels state that the contents of the package are sterile and does not clarify that this sterility claim is only applicable to the applicator. The antiseptic solution that is applied to the skin is a cutaneous disinfectant, and is not sterilized. Some product labeling states ''Sterility guaranteed unless seal broken'' or ''Contents sterile if package is intact.'' These claims were intended to indicate surface sterilization only but could mistakenly lead to the conclusion that the drug product solution is sterile. It was determined that labeling on certain products could be misleading in relation to sterility claims. ",3/22/2013,"03/22/2013",4/17/2013,"04/17/2013"
"Devices",64776,"Ongoing","Lighthouse For The Blind","Olivette","MO","US","Voluntary: Firm Initiated","E-Mail","Nationwide Distribution including DC and the states of AK, AL, AR, AZ, CA, CO, DE, FL, GA, ID, IL, IN, KS, KY, MI, MD, MN, MO, MT, NC, NJ, NM, NY, NV, OH, OK, PA, SC, TN, TX, UT, VA, WA and WY.","Z-1087-2013","Class III","LHB, Antiseptic Kit, Povidone Swab, Gauze Pads, and non-stick pads. Kit Number: 2113305. First Aid Kit.","All kits shipped between 1/12010 through 3/4/2013. ",,"2,815 kits","The product contains an iodine 10% Ampule (10% Povidone Iodine swab) which is being recalled by the firm's distributor. The labeling of the iodine 10% Ampule labels state that the contents of the package are sterile and does not clarify that this sterility claim is only applicable to the applicator. The antiseptic solution that is applied to the skin is a cutaneous disinfectant, and is not sterilized. Some product labeling states ''Sterility guaranteed unless seal broken'' or ''Contents sterile if package is intact.'' These claims were intended to indicate surface sterilization only but could mistakenly lead to the conclusion that the drug product solution is sterile. It was determined that labeling on certain products could be misleading in relation to sterility claims. ",3/22/2013,"03/22/2013",4/17/2013,"04/17/2013"
"Devices",64776,"Ongoing","Lighthouse For The Blind","Olivette","MO","US","Voluntary: Firm Initiated","E-Mail","Nationwide Distribution including DC and the states of AK, AL, AR, AZ, CA, CO, DE, FL, GA, ID, IL, IN, KS, KY, MI, MD, MN, MO, MT, NC, NJ, NM, NY, NV, OH, OK, PA, SC, TN, TX, UT, VA, WA and WY.","Z-1089-2013","Class III","LHB, Perishable Items Pack Type I , Kit Number: 2114002-100. First Aid Kit.","All kits shipped between 1/12010 through 3/4/2013. ",,"1,034 kits","The product contains an iodine 10% Ampule (10% Povidone Iodine swab) which is being recalled by the firm's distributor. The labeling of the iodine 10% Ampule labels state that the contents of the package are sterile and does not clarify that this sterility claim is only applicable to the applicator. The antiseptic solution that is applied to the skin is a cutaneous disinfectant, and is not sterilized. Some product labeling states ''Sterility guaranteed unless seal broken'' or ''Contents sterile if package is intact.'' These claims were intended to indicate surface sterilization only but could mistakenly lead to the conclusion that the drug product solution is sterile. It was determined that labeling on certain products could be misleading in relation to sterility claims. ",3/22/2013,"03/22/2013",4/17/2013,"04/17/2013"
"Devices",64776,"Ongoing","Lighthouse For The Blind","Olivette","MO","US","Voluntary: Firm Initiated","E-Mail","Nationwide Distribution including DC and the states of AK, AL, AR, AZ, CA, CO, DE, FL, GA, ID, IL, IN, KS, KY, MI, MD, MN, MO, MT, NC, NJ, NM, NY, NV, OH, OK, PA, SC, TN, TX, UT, VA, WA and WY.","Z-1091-2013","Class III","LHB, Perishable Item Pack Type III. Kit number: 2114011-100. First Aid Kit.","All kits shipped between 1/12010 through 3/4/2013. ",,"227 kits","The product contains an iodine 10% Ampule (10% Povidone Iodine swab) which is being recalled by the firm's distributor. The labeling of the iodine 10% Ampule labels state that the contents of the package are sterile and does not clarify that this sterility claim is only applicable to the applicator. The antiseptic solution that is applied to the skin is a cutaneous disinfectant, and is not sterilized. Some product labeling states ''Sterility guaranteed unless seal broken'' or ''Contents sterile if package is intact.'' These claims were intended to indicate surface sterilization only but could mistakenly lead to the conclusion that the drug product solution is sterile. It was determined that labeling on certain products could be misleading in relation to sterility claims. ",3/22/2013,"03/22/2013",4/17/2013,"04/17/2013"
"Devices",64776,"Ongoing","Lighthouse For The Blind","Olivette","MO","US","Voluntary: Firm Initiated","E-Mail","Nationwide Distribution including DC and the states of AK, AL, AR, AZ, CA, CO, DE, FL, GA, ID, IL, IN, KS, KY, MI, MD, MN, MO, MT, NC, NJ, NM, NY, NV, OH, OK, PA, SC, TN, TX, UT, VA, WA and WY.","Z-1088-2013","Class III","LHB, First Aid Type I Individual Kit, NSN: 6545-00-656-1092, antiseptics, Kit number: 2114002. First Aid Kit.","All kits shipped between 1/12010 through 3/4/2013. ",,"56,133 kits","The product contains an iodine 10% Ampule (10% Povidone Iodine swab) which is being recalled by the firm's distributor. The labeling of the iodine 10% Ampule labels state that the contents of the package are sterile and does not clarify that this sterility claim is only applicable to the applicator. The antiseptic solution that is applied to the skin is a cutaneous disinfectant, and is not sterilized. Some product labeling states ''Sterility guaranteed unless seal broken'' or ''Contents sterile if package is intact.'' These claims were intended to indicate surface sterilization only but could mistakenly lead to the conclusion that the drug product solution is sterile. It was determined that labeling on certain products could be misleading in relation to sterility claims. ",3/22/2013,"03/22/2013",4/17/2013,"04/17/2013"
"Veterinary",64777,"Ongoing","Wilbur Ellis Co","Vancouver","WA","US","Voluntary: Firm Initiated","Telephone","Distributed in Oregon","V-145-2013","Class III","Messerle & Sons Dewormer Mineral. Product is Type B medicated mineral premix (dewormer), formulated to contain fendendazole. The product is labeled in parts: ''***Messerle & Sons Dewormer Mineral***MEDICATED***ACTIVE DRUG INGREDIENTS Fenbendazole***4540 g/ton***Manufactured by: Wilbur-Ellis Company P.O Box 407 Clackmas, OR 97015***Net Weight 50 lbs***''.","MESRL003 03/2010; Lot 644370; Expiration date: September 2014",".","1950 lbs.","Messerle & Sons Dewormer Mineral is recalled because Fenbendazole drug concentration was exceeded the AV allowed.",3/26/2013,"03/26/2013",4/24/2013,"04/24/2013"
"Devices",64778,"Ongoing","Integra LifeSciences Corporation","Plainsboro","NJ","US","Voluntary: Firm Initiated","Letter","Worldwide distribution: USA (nationwide) including Puerto Rico and countries of: Arab Emirates, Argentina, Belgium, Brasil, Canada, Chile, China, Costa Rica, Denmark, Egypt, Spain, France, Great Britain, Italy, Japan, Peru, Singapore, Thailand, and South Africa.","Z-1298-2013","Class II","OraMem Absorbable Collagen Membrane OraMem Absorbable Collagen Membrane is an absorbable, implantable material that is indicated for guided tissue regeneration procedures in periodontal defects to enhance regeneration of the periodontal apparatus.","1112066",,"812 boxes","Due to the process deviation, product lots in question may have been released with higher levels of pyrogens than permitted by the specifications for the products. ",3/28/2013,"03/28/2013",5/22/2013,"05/22/2013"
"Devices",64778,"Ongoing","Integra LifeSciences Corporation","Plainsboro","NJ","US","Voluntary: Firm Initiated","Letter","Worldwide distribution: USA (nationwide) including Puerto Rico and countries of: Arab Emirates, Argentina, Belgium, Brasil, Canada, Chile, China, Costa Rica, Denmark, Egypt, Spain, France, Great Britain, Italy, Japan, Peru, Singapore, Thailand, and South Africa.","Z-1297-2013","Class II","Ora Plug Absorbable Collagen Wound Dressing for Dental Surgery The Absorbable Collagen Wound Dressings for Dental Surgery are intended for use on moist or bleeding oral wounds where a stabilized blood clot can help protect the surface of the wound from further injury. Topical administration of the Absorbable Collagen Wound Dressings directly over the wound effectively controls bleeding usually within two to five minutes.","1110144, 1110243 1110782, 1111645",,"31,940 boxes","Due to the process deviation, product lots in question may have been released with higher levels of pyrogens than permitted by the specifications for the products. ",3/28/2013,"03/28/2013",5/22/2013,"05/22/2013"
"Devices",64778,"Ongoing","Integra LifeSciences Corporation","Plainsboro","NJ","US","Voluntary: Firm Initiated","Letter","Worldwide distribution: USA (nationwide) including Puerto Rico and countries of: Arab Emirates, Argentina, Belgium, Brasil, Canada, Chile, China, Costa Rica, Denmark, Egypt, Spain, France, Great Britain, Italy, Japan, Peru, Singapore, Thailand, and South Africa.","Z-1294-2013","Class II","HeliTape Absorbable Collagen Wound Dressing for Dental Surgery The Absorbable Collagen Wound Dressings for Dental Surgery are intended for use on moist or bleeding oral wounds where a stabilized blood clot can help protect the surface of the wound from further injury. Topical administration of the Absorbable Collagen Wound Dressings directly over the wound effectively controls bleeding usually within two to five minutes.","1125414, 1126013 1130645, 1110250 1110251, 1110252 1111365, 1111878",,"19,030 boxes","Due to the process deviation, product lots in question may have been released with higher levels of pyrogens than permitted by the specifications for the products. ",3/28/2013,"03/28/2013",5/22/2013,"05/22/2013"
"Devices",64778,"Ongoing","Integra LifeSciences Corporation","Plainsboro","NJ","US","Voluntary: Firm Initiated","Letter","Worldwide distribution: USA (nationwide) including Puerto Rico and countries of: Arab Emirates, Argentina, Belgium, Brasil, Canada, Chile, China, Costa Rica, Denmark, Egypt, Spain, France, Great Britain, Italy, Japan, Peru, Singapore, Thailand, and South Africa.","Z-1288-2013","Class II","INSTAT - Agent, Absorbable Hemostatic, Collagen Based INSTAT MCH is recommended for use in surgical procedures (other than Urological and Ophthalmological surgery) as an adjunct to hemostatis when control of bleeding by ligature or conventional procedures is ineffective or impractical.","1105177, 1105178 1110143, 1110227 1110228, 1110229 1110230, 1110233 1110786, 1110787 1111356, 1105179 111023 1, 1110232 1110785",,"17, 616 boxes","Due to the process deviation, product lots in question may have been released with higher levels of pyrogens than permitted by the specifications for the products. ",3/28/2013,"03/28/2013",5/22/2013,"05/22/2013"
"Devices",64778,"Ongoing","Integra LifeSciences Corporation","Plainsboro","NJ","US","Voluntary: Firm Initiated","Letter","Worldwide distribution: USA (nationwide) including Puerto Rico and countries of: Arab Emirates, Argentina, Belgium, Brasil, Canada, Chile, China, Costa Rica, Denmark, Egypt, Spain, France, Great Britain, Italy, Japan, Peru, Singapore, Thailand, and South Africa.","Z-1295-2013","Class II","HeliPlug Absorbable Collagen Wound Dressing for Dental Surgery The Absorbable Collagen Wound Dressings for Dental Surgery are intended for use on moist or bleeding oral wounds where a stabilized blood clot can help protect the surface of the wound from further injury. Topical administration of the Absorbable Collagen Wound Dressings directly over the wound effectively controls bleeding usually within two to five minutes.","1104622, 1104962 1110241, 1110242 1110264, 1110783",,"42,570 boxes","Due to the process deviation, product lots in question may have been released with higher levels of pyrogens than permitted by the specifications for the products. ",3/28/2013,"03/28/2013",5/22/2013,"05/22/2013"
"Devices",64778,"Ongoing","Integra LifeSciences Corporation","Plainsboro","NJ","US","Voluntary: Firm Initiated","Letter","Worldwide distribution: USA (nationwide) including Puerto Rico and countries of: Arab Emirates, Argentina, Belgium, Brasil, Canada, Chile, China, Costa Rica, Denmark, Egypt, Spain, France, Great Britain, Italy, Japan, Peru, Singapore, Thailand, and South Africa.","Z-1299-2013","Class II","BioMend Extend'' Absorbable Collagen Membrane BioMend Extend'' Absorbable Collagen Membrane is an absorbable, implantable material that is indicated for guided tissue regeneration procedures in periodontal defects to enhance regeneration of the periodontal apparatus.","1104846, 1105175 1105253, 1110810 1110811, 1111149 1111859, 1104847 1105176, 1105254 1110809, 1111860 1104848, 1110819 1110820, 1111148 1111861",,"20,032 boxes","Due to the process deviation, product lots in question may have been released with higher levels of pyrogens than permitted by the specifications for the products. ",3/28/2013,"03/28/2013",5/22/2013,"05/22/2013"
"Devices",64778,"Ongoing","Integra LifeSciences Corporation","Plainsboro","NJ","US","Voluntary: Firm Initiated","Letter","Worldwide distribution: USA (nationwide) including Puerto Rico and countries of: Arab Emirates, Argentina, Belgium, Brasil, Canada, Chile, China, Costa Rica, Denmark, Egypt, Spain, France, Great Britain, Italy, Japan, Peru, Singapore, Thailand, and South Africa.","Z-1286-2013","Class II","NeuraWrap Nerve Protector NeuraWrap Nerve Protector is indicated for the management of peripheral nerve injuries in which there has been no substantial loss of nerve tissue.","1112107 1111938, 1112280, 1112038, 1111971 1112279, 1112104, 1112105 1112297, ",,"954 boxes","Due to the process deviation, product lots in question may have been released with higher levels of pyrogens than permitted by the specifications for the products. ",3/28/2013,"03/28/2013",5/22/2013,"05/22/2013"
"Devices",64778,"Ongoing","Integra LifeSciences Corporation","Plainsboro","NJ","US","Voluntary: Firm Initiated","Letter","Worldwide distribution: USA (nationwide) including Puerto Rico and countries of: Arab Emirates, Argentina, Belgium, Brasil, Canada, Chile, China, Costa Rica, Denmark, Egypt, Spain, France, Great Britain, Italy, Japan, Peru, Singapore, Thailand, and South Africa.","Z-1291-2013","Class II","Colla Tape Absorbable Collagen Wound Dressing for Dental Surgery The Absorbable Collagen Wound Dressings for Dental Surgery are intended for use on moist or bleeding oral wounds where a stabilized blood clot can help protect the surface of the wound from further injury. Topical administration of the Absorbable Collagen Wound Dressings directly over the wound effectively controls bleeding usually within two to five minutes.","1125130 ,1125686 1125687, 1125688 1126015, 1105298 1110145, 1110674 1111854, 1104502 1104503, 1105309 1105310, 1110249 1111366, 1111367 1111368, 1111370 1112262",,"49,500 boxes","Due to the process deviation, product lots in question may have been released with higher levels of pyrogens than permitted by the specifications for the products. ",3/28/2013,"03/28/2013",5/22/2013,"05/22/2013"
"Devices",64778,"Ongoing","Integra LifeSciences Corporation","Plainsboro","NJ","US","Voluntary: Firm Initiated","Letter","Worldwide distribution: USA (nationwide) including Puerto Rico and countries of: Arab Emirates, Argentina, Belgium, Brasil, Canada, Chile, China, Costa Rica, Denmark, Egypt, Spain, France, Great Britain, Italy, Japan, Peru, Singapore, Thailand, and South Africa.","Z-1301-2013","Class II","BioMend Absorbable Collagen Membrane BioMend Absorbable Collagen Membrane is an absorbable, implantable material that is indicated for guided tissue regeneration procedures in periodontal defects to enhance regeneration of the periodontal apparatus.","1105251, 1105462, 1110805, 1110806, 1111144, 1110480, 1111145, 1111358, 1105392, 1110142, 1110807, 1111146, 1111362, 1111640, 1105252, 1105463, 1110808, 1111147, 1111865, 1110671, 1110672, 1111958, 1105393, 1111959, 1105394, 1110480, 1112022, 1105391",,"32,446 boxes","Due to the process deviation, product lots in question may have been released with higher levels of pyrogens than permitted by the specifications for the products. ",3/28/2013,"03/28/2013",5/22/2013,"05/22/2013"
"Devices",64778,"Ongoing","Integra LifeSciences Corporation","Plainsboro","NJ","US","Voluntary: Firm Initiated","Letter","Worldwide distribution: USA (nationwide) including Puerto Rico and countries of: Arab Emirates, Argentina, Belgium, Brasil, Canada, Chile, China, Costa Rica, Denmark, Egypt, Spain, France, Great Britain, Italy, Japan, Peru, Singapore, Thailand, and South Africa.","Z-1285-2013","Class II","DuraGen XS Dural Regeneration Matrix DuraGen XS Dural Regenerative Matrix is an absorbable implant for repair of dural defects. DuraGen XS is an easy to handle, soft, white, pliable, non-friable, porous collagen matrix. DuraGen XS is supplied sterile, non-pyrogenic, for single use in double peel packages in a variety of sizes.","1125963, 1130387 1130386, 1130468 ",,"52 boxes","Due to the process deviation, product lots in question may have been released with higher levels of pyrogens than permitted by the specifications for the products. ",3/28/2013,"03/28/2013",5/22/2013,"05/22/2013"
"Devices",64778,"Ongoing","Integra LifeSciences Corporation","Plainsboro","NJ","US","Voluntary: Firm Initiated","Letter","Worldwide distribution: USA (nationwide) including Puerto Rico and countries of: Arab Emirates, Argentina, Belgium, Brasil, Canada, Chile, China, Costa Rica, Denmark, Egypt, Spain, France, Great Britain, Italy, Japan, Peru, Singapore, Thailand, and South Africa.","Z-1302-2013","Class II","Absorbable Collagen Sponge Provided As Intermediate to Another Company","1130055, 1130057, 1130228, 1130229, 1130388, 1105192, 1110821, 1110822, 1110987, 1111023, 1112020, 1112379, 1104815, 1110841, 1110842, 1110843, 1110953, 1110954, 1111022, 1111821, 1105206, 1110844, 1110903, 1110904, 1110931, 1110932, 1112021, 1104791, 1104961, 1105174, 1105453, 1105454, 1110826, 1110827, 1110969, 1111159, 1111160, 1104710, 1110828, 1111158, 1111764",,"84,460 boxes","Due to the process deviation, product lots in question may have been released with higher levels of pyrogens than permitted by the specifications for the products. ",3/28/2013,"03/28/2013",5/22/2013,"05/22/2013"
"Devices",64778,"Ongoing","Integra LifeSciences Corporation","Plainsboro","NJ","US","Voluntary: Firm Initiated","Letter","Worldwide distribution: USA (nationwide) including Puerto Rico and countries of: Arab Emirates, Argentina, Belgium, Brasil, Canada, Chile, China, Costa Rica, Denmark, Egypt, Spain, France, Great Britain, Italy, Japan, Peru, Singapore, Thailand, and South Africa.","Z-1296-2013","Class II","OraTape Absorbable Collagen Wound Dressing for Dental Surgery The Absorbable Collagen Wound Dressings for Dental Surgery are intended for use on moist or bleeding oral wounds where a stabilized blood clot can help protect the surface of the wound from further injury. Topical administration of the Absorbable Collagen Wound Dressings directly over the wound effectively controls bleeding usually within two to five minutes.","1126012, 1105396 1105397, 1105398 1105399, 1111364 1111641",,"17,110 boxes","Due to the process deviation, product lots in question may have been released with higher levels of pyrogens than permitted by the specifications for the products. ",3/28/2013,"03/28/2013",5/22/2013,"05/22/2013"
"Devices",64778,"Ongoing","Integra LifeSciences Corporation","Plainsboro","NJ","US","Voluntary: Firm Initiated","Letter","Worldwide distribution: USA (nationwide) including Puerto Rico and countries of: Arab Emirates, Argentina, Belgium, Brasil, Canada, Chile, China, Costa Rica, Denmark, Egypt, Spain, France, Great Britain, Italy, Japan, Peru, Singapore, Thailand, and South Africa.","Z-1289-2013","Class II","Helistat Absorbable Hemostatic,Collagen Based Helistat is indicated in surgical procedures (other than ophthalmological and urological surgery) as an adjunct to hemostasis when control of bleeding by ligature or conventional procedures is ineffective or impractical.","1104789 1104790, 1110793 1112248, 1110248 1111867",,"24,342 boxes","Due to the process deviation, product lots in question may have been released with higher levels of pyrogens than permitted by the specifications for the products. ",3/28/2013,"03/28/2013",5/22/2013,"05/22/2013"
"Devices",64778,"Ongoing","Integra LifeSciences Corporation","Plainsboro","NJ","US","Voluntary: Firm Initiated","Letter","Worldwide distribution: USA (nationwide) including Puerto Rico and countries of: Arab Emirates, Argentina, Belgium, Brasil, Canada, Chile, China, Costa Rica, Denmark, Egypt, Spain, France, Great Britain, Italy, Japan, Peru, Singapore, Thailand, and South Africa.","Z-1282-2013","Class II","Dural Graft Matrix DuraGen Dural Graft Matrix is an absorbable implant for repair of dural defects. DuraGen matrix is an easy to handle, soft, white, pliable, nonfriable, porous collagen matrix. DuraGen matrix is supplied sterile, nonpyrogenic, for single use in double peel packages in a variety of sizes..","1125807, 1125802, 1125806, 1125804, 1125808, 1111845, 1125805, 1125803, 1125809, 1125810, 1130069, 1130061, 1130064, 1130065, 1130417, 1130521, 1110850, 1111839, 1111621, 1110274, 1105302, 1110669, 1111618, 1112228, 1110160, 1110670, 1111606, 1111616, 1104916, 1111614, 1111615, 1110273, 1111277, 1111849, 1110667, 1104918, 1110853, 1111619, 1111842, 1110666, 1112109, 1112108, 1104917, 1110854, 1111620, 1110276, 1105301, 1111846, 1112225, 1110851, 1111617, 1105303, 1110852, 1110270, 1105304, 1110246, 1112222, 1112224, 1110245, 1111844, 1111850, 1110668, 1125522, 1125628, 1104879, 1110814, 1111610, 1125525, 1104876, 1110815, 1111607, 1125526",,"15,607 boxes","Due to the process deviation, product lots in question may have been released with higher levels of pyrogens than permitted by the specifications for the products. ",3/28/2013,"03/28/2013",5/22/2013,"05/22/2013"
"Devices",64778,"Ongoing","Integra LifeSciences Corporation","Plainsboro","NJ","US","Voluntary: Firm Initiated","Letter","Worldwide distribution: USA (nationwide) including Puerto Rico and countries of: Arab Emirates, Argentina, Belgium, Brasil, Canada, Chile, China, Costa Rica, Denmark, Egypt, Spain, France, Great Britain, Italy, Japan, Peru, Singapore, Thailand, and South Africa.","Z-1290-2013","Class II","Helitene Absorbable Collagen Hemostatic Sponge Helitene is indicated in surgical procedures (other than ophthalmological and urological surgery) as an adjunct to hemostasis when control of bleeding by ligature or conventional procedures is ineffective or impractical.","1110788, 1112217 1110222, 1111357 1111602, 1105255 1110224, 1110225 1111601, 1110223 1110790, 1111603",,"14, 525 boxes","Due to the process deviation, product lots in question may have been released with higher levels of pyrogens than permitted by the specifications for the products. ",3/28/2013,"03/28/2013",5/22/2013,"05/22/2013"
"Devices",64778,"Ongoing","Integra LifeSciences Corporation","Plainsboro","NJ","US","Voluntary: Firm Initiated","Letter","Worldwide distribution: USA (nationwide) including Puerto Rico and countries of: Arab Emirates, Argentina, Belgium, Brasil, Canada, Chile, China, Costa Rica, Denmark, Egypt, Spain, France, Great Britain, Italy, Japan, Peru, Singapore, Thailand, and South Africa.","Z-1293-2013","Class II","CollaPlug Absorbable Collagen Wound Dressing for Dental Surgery The Absorbable Collagen Wound Dressings for Dental Surgery are intended for use on moist or bleeding oral wounds where a stabilized blood clot can help protect the surface of the wound from further injury. Topical administration of the Absorbable Collagen Wound Dressings directly over the wound effectively controls bleeding usually within two to five minutes.","1104500, 1104623 1105315, 1105316 1105317, 1110234 1110235, 1110236 1110237, 1110238 1110239, 1110240 1110784, 1111151 1111152, 1111153 1111155, 1111156 1111157, 1111646 1105300",,"155,850 boxes","Due to the process deviation, product lots in question may have been released with higher levels of pyrogens than permitted by the specifications for the products. ",3/28/2013,"03/28/2013",5/22/2013,"05/22/2013"
"Devices",64778,"Ongoing","Integra LifeSciences Corporation","Plainsboro","NJ","US","Voluntary: Firm Initiated","Letter","Worldwide distribution: USA (nationwide) including Puerto Rico and countries of: Arab Emirates, Argentina, Belgium, Brasil, Canada, Chile, China, Costa Rica, Denmark, Egypt, Spain, France, Great Britain, Italy, Japan, Peru, Singapore, Thailand, and South Africa.","Z-1292-2013","Class II","CollaCote Absorbable Collagen Wound Dressing for Dental Surgery The Absorbable Collagen Wound Dressings for Dental Surgery are intended for use on moist or bleeding oral wounds where a stabilized blood clot can help protect the surface of the wound from further injury. Topical administration of the Absorbable Collagen Wound Dressings directly over the wound effectively controls bleeding usually within two to five minutes.","1125684, 1125685 1125689, 1126014 1104963, 1110481 1110791, 1110792 1111363, 1111644 1110673, 1111856 ",,"32,790 boxes","Due to the process deviation, product lots in question may have been released with higher levels of pyrogens than permitted by the specifications for the products. ",3/28/2013,"03/28/2013",5/22/2013,"05/22/2013"
"Devices",64778,"Ongoing","Integra LifeSciences Corporation","Plainsboro","NJ","US","Voluntary: Firm Initiated","Letter","Worldwide distribution: USA (nationwide) including Puerto Rico and countries of: Arab Emirates, Argentina, Belgium, Brasil, Canada, Chile, China, Costa Rica, Denmark, Egypt, Spain, France, Great Britain, Italy, Japan, Peru, Singapore, Thailand, and South Africa.","Z-1300-2013","Class II","Layershield Adhesion Barrier Matrix Layershield Adhesion Barrier Matrix is an absorbable implant for use as an adhesion barrier for the reduction of peridural fibrosis.","1125812 1125816 1126021",,"215 boxes","Due to the process deviation, product lots in question may have been released with higher levels of pyrogens than permitted by the specifications for the products. ",3/28/2013,"03/28/2013",5/22/2013,"05/22/2013"
"Devices",64778,"Ongoing","Integra LifeSciences Corporation","Plainsboro","NJ","US","Voluntary: Firm Initiated","Letter","Worldwide distribution: USA (nationwide) including Puerto Rico and countries of: Arab Emirates, Argentina, Belgium, Brasil, Canada, Chile, China, Costa Rica, Denmark, Egypt, Spain, France, Great Britain, Italy, Japan, Peru, Singapore, Thailand, and South Africa.","Z-1287-2013","Class II","NeuraGen Nerve Guide NeuraGen Nerve Guide is indicated for repair of peripheral nerve discontinuities where gap closure can be achieved by flexion of the extremity.","1105457 1112377, 1112378 1112103 1112106, 1112003, 1112296, 1110715 1112052, 1112004, 1112030 1111972 1112376",,"1,661 boxes","Due to the process deviation, product lots in question may have been released with higher levels of pyrogens than permitted by the specifications for the products. ",3/28/2013,"03/28/2013",5/22/2013,"05/22/2013"
"Devices",64778,"Ongoing","Integra LifeSciences Corporation","Plainsboro","NJ","US","Voluntary: Firm Initiated","Letter","Worldwide distribution: USA (nationwide) including Puerto Rico and countries of: Arab Emirates, Argentina, Belgium, Brasil, Canada, Chile, China, Costa Rica, Denmark, Egypt, Spain, France, Great Britain, Italy, Japan, Peru, Singapore, Thailand, and South Africa.","Z-1283-2013","Class II","Suturable DuraGen Dural Regenerative Matrix Suturable DuraGen Dural Regenerative Matrix is an absorbable implant for repair of dural defects. Suturable DuraGen is an easy to handle, soft, white, pliable, nonfriable, porous collagen matrix with a mechanically strengthened collagen component. Suturable DuraGen is supplied sterile, non-pyrogenic, for single use in double peel packages in a variety of sizes. Suturable DuraGen may be applied using either on-lay or suturing techniques depending on clinical need and surgeon preference.","1125682, 1125681 1125817, 1125983, 1126018 1126019, 1130641 1130642, 1110848, 1110849 1111883, 1111354, 1111884 1111936, 1112151 1110256, 1111355",,"4, 799 boxes","Due to the process deviation, product lots in question may have been released with higher levels of pyrogens than permitted by the specifications for the products. ",3/28/2013,"03/28/2013",5/22/2013,"05/22/2013"
"Devices",64778,"Ongoing","Integra LifeSciences Corporation","Plainsboro","NJ","US","Voluntary: Firm Initiated","Letter","Worldwide distribution: USA (nationwide) including Puerto Rico and countries of: Arab Emirates, Argentina, Belgium, Brasil, Canada, Chile, China, Costa Rica, Denmark, Egypt, Spain, France, Great Britain, Italy, Japan, Peru, Singapore, Thailand, and South Africa.","Z-1284-2013","Class II","DuraGen Plus Dural Regeneration Matrix DuraGen Plus Adhesion Barrier Matrix is an absorbable implant for repair and restoration of dural defects and as an adhesion barrier for the reduction of peridural fibrosis. DuraGen Plus matrix is an easy to handle, soft, white pliable, non-friable, porous, collagen matrix. DuraGen Plus matrix is supplied sterile, nonpyrogenic, for single use in double peel packages in a variety of sizes.","1125523, 1125517 1125522, 1125539 1125524, 1125525 1125526, 1125632 1125630, 1125678 1125679 1125677, 1125683 1125628, 1125813 1125814, 1125815 1125629, 1125520 1125521, 1125979 1126031, 1125980 1125981, 1125982 1126030, 1130243 1130071, 1130503 1130379, 1130381 1130384, 1130507 1130374, 1130380 1130382, 1130421 1130505, 1130424 1130654, 1130422 1130423, 1130428 1130639, 1130413 1130414, 1130383 1130425, 1130504 1130506, 1130426 1130427, 1130970 1130827, 1111606 1104879, 1110814 1111610, 1104876 1110815, 1111607 1110268, 1111360 1112339, 1104405 1104877, 1105455 1112008, 1112110 1112111, 1110845 1111940, 1112149 1104880, 1112148 1110244, 1110265 1110846, 1104878 1111609, 1111941 1104881, 1110812, 1110267, 1111359, 1112340, 1105307, 1111611, 1111939, 1112341, 1110266 1112146, 1112147",,"21,179 boxes","Due to the process deviation, product lots in question may have been released with higher levels of pyrogens than permitted by the specifications for the products. ",3/28/2013,"03/28/2013",5/22/2013,"05/22/2013"
"Biologics",64779,"Terminated","LifeServe Blood Center","Des Moines","IA","US","Voluntary: Firm Initiated","Telephone","Iowa","B-1598-13","Class III","Platelets Pooled Leukocytes Reduced","W037913556748; ",,"1","Blood product, which was not quarantined subsequent to receiving post donation medical information, was distributed.",3/18/2013,"03/18/2013",6/26/2013,"06/26/2013"
"Biologics",64780,"Terminated","BloodCenter of Wisconsin, Inc","Milwaukee","WI","US","Voluntary: Firm Initiated","FAX","Switzerland","B-1444-13","Class II","Blood and Blood Products for Reprocessing","W036312583037; W036312506313",".","2 products","Blood products, collected from a donor with risk factors for vCJD, were distributed. ",2/1/2013,"02/01/2013",5/1/2013,"05/01/2013"
"Devices",64781,"Ongoing","Advanced Sterilization Products","Irvine","CA","US","Voluntary: Firm Initiated","Letter","Nationwide Distribution","Z-1150-2013","Class II","EVOTECH Endoscope Cleaner and Reprocessor System, P/N 50004. Designed to automatically clean and high-level disinfect flexible, submersible video or fiber-optic endoscopes.","Batch Numbers: 5041090177 5041090127 5041090131 5041110307 5041120049 5041120065 5041120076 5041100256 5041110157 5041120133 5040107029 5041110264 5041110265 5041110280 5041100218 5041100219 5041110018 5041110143 5041110079 5041110329 5041110212 5041120155 5041100250 5041110080 5041110174 5041110330 5041110203 5041090103 5041090110 5041100103 5041100104 5041100142 5041090184 5041090185 5041120120 5041120070 5041120073 5041120080 5040107087 5041110158 5041100189 5041100186 5041110189 5041080029 5041080063 5041120034 5041080028 5041080060 5041080064 5041100145 5041100146 5041100151 5041100268 5041120081 5040107065 5041120087 5041120116 5041110111 5041110113 5040107115 5041070037 5041110121 5041110140 5041090067 5041090167 5041090168 5041120154 5041090179 5041110177 5041110112 5041110129 5041110130 5041090069 5041110271 5041070036 5041070044 5041070045 5041090034 5041090054 5041090147 5041100192 5041090203 5041100214 5041100265 5041110186 5041110187 5041100067 5041100071 5041100079 5041110075 5041110078 5041120111 5041100136 5041100164 5041100043 5041100046 5041100047 5041110191 5041100262 5041110155 5041110154 5041110327 5041090128 5041110185 5041120060 5041120108 5041110316 5041110231 5041110246 5041090146 5041110291 5041120203 5041090061 5041090063 5041100068 5041100076 5041100222 5041090205 5041090097 5041090141 5041110182 5041090145 5041090129 5041100257 5041120149 5041120152 5041110127 5041130007 5041130008 5041120137 5041110176 5041110188 5041110183 5041100126 5041100127 5041100156 5041070042 5041080077 5041090108 5041100197 5041110120 5041100162 5041090194 5041110131 5041110142 5041110147 5041120094 5041080071 5041080062 5041090175 5041110172 5041110173 5041120071 5041090182 5041100036 5040107105 5041100248 5041100251 5041120150 5041090090 5041090092 5041100077 5041100081 5041100089 5041100259 5041100167 5041100020 5041100025 5041100220 5041120036 5041100205 5041100211 5041110213 5041120179 5041120185 5041110283 5041110315 5041100233 5041100107 5041100108 5041100116 5041100117 5041110228 5041110247 504111",".","761 units","Advanced Sterilization Products (ASP) is recalling the EVOTECH Endoscope Cleaner and Reprocessor (ECR) because they have received reports of smoke emanating from the system due to a circuit board malfunction that may occur in the Channel Control Manifold sub-assembly.",3/28/2013,"03/28/2013",4/24/2013,"04/24/2013"
"Devices",64782,"Ongoing","Edwards Lifesciences, LLC","Draper","UT","US","Voluntary: Firm Initiated","Letter","USA Nationwide Distribution including the states of: FL, MA, MI, NY, PA, TX.","Z-1111-2013","Class II","Edwards Lifesciences Duraflo coated Femoral Cannula. Product Usage: The cannulae are intended for use in situations which require rapid femoral venous and arterial access for short-term (< 6 hours) cardiopulmonary bypass. Vessel access (venous or arterial) is left to the discretion of the physician. Extracorporeal circuit components with a Duraflo coating are intended for use in cardiopulmonary surgery when a heparin-coated blood path is desired. The femoral arterial cannulae are wire-reinforced, thin-wall cannulae. ","Model DIIFEMII018A, Lot 59337174",".","379 units","Two unsealed pouches were found at an Edwards' distribution location in Japan. Incorrectly sealed pouches may result in a sterility barrier breach.",3/14/2013,"03/14/2013",4/24/2013,"04/24/2013"
"Devices",64783,"Ongoing","Philips And Neusoft Medical Systems Co., Ltd.","Shenyang, Liaoning",,"CN","Voluntary: Firm Initiated","Letter","Nationwide distribution: USA including states of: California, Connecticut, North Carolina, Nebraska, Ohio, South Carolina, Texas, and Puerto Rico.","Z-1166-2013","Class II","NeuViz Dual series CT Scanner System, Part number (PN): 989605651321. This is a computed X-ray, Tomography system. NeuViz Dual Multi-slice CT Scanner System is intended to produce cross-section images of head and body by computer reconstruction of X-ray transmission data taken at different angles. ","Serial numbers: 400562, 400563, 400626, NDH009EI, NDH011EI, NDH012EI, NDH013EI, NDH016EI, NDH017EI, NDH026EI, NDH027EI, NDH028EI, NDH030EI, NDH031EI, NDH034EI, NDHR080001, NDHR080002, NDHR080003, NDHR080004, NDHR080007, NDHR080012, NDHR080021, NDHR090003, NDHR090012, and NDHR090013.",".","25 units","User error of the NeuViz 16 or NeuViz Dual may cause personnel injuries. There was a report where a finger was pinched when the table was moved backward while the tabletop was controlled by another person from the gantry left control panel.",3/4/2013,"03/04/2013",5/1/2013,"05/01/2013"
"Devices",64783,"Ongoing","Philips And Neusoft Medical Systems Co., Ltd.","Shenyang, Liaoning",,"CN","Voluntary: Firm Initiated","Letter","Nationwide distribution: USA including states of: California, Connecticut, North Carolina, Nebraska, Ohio, South Carolina, Texas, and Puerto Rico.","Z-1165-2013","Class II","NeuViz 16 Multi-Slice CT Scanner System, Part number (PN): 989605858501, Model: NeuViz 16. This is a computed X-ray, Tomography system. The NeuViz 16 CT Scanner System can be used as a whole body computed tomography X-ray system featuring a continuously rotating X-ray tube and detector array with multi-slice capability up to 16 slices simultaneously. The acquired X-RAY transmission data is reconstructed by computer into cross-sectional images of the body from the same axial plane taken at different angles. The system is suitable for all patients","Serial numbers: N16E090002, N16E090003, N16E090004, N16E090007, N16E090008, N16E090010, N16E100015, N16E100017, N16E100023, N16E110016, N16E110023, N16E110026, N16E110027, N16E110040, N16E110053, N16E120016, N16E120020, N16E120022, N16E120023, N16E120024, N16E120052, N16E120053, and N16E130002. ",".","23 units","User error of the NeuViz 16 or NeuViz Dual may cause personnel injuries. There was a report where a finger was pinched when the table was moved backward while the tabletop was controlled by another person from the gantry left control panel.",3/4/2013,"03/04/2013",5/1/2013,"05/01/2013"
"Devices",64787,"Ongoing","GE Healthcare It","Barrington","IL","US","Voluntary: Firm Initiated","Letter","USA Nationwide Distribution in the state of OK","Z-0034-2014","Class II","Centricity Cardio Imaging 5.0 is a software only Picture Archiving and Communication System (PACS). Product Usage: It will be sold as a software only device to operate on general purpose computing hardware. Centricity Cardio Imaging receives medical images and other information from various data sources. Information can be stored, communicated, processed and displayed within the system or across computer networks at distributed locations. Centricity Cardio Imaging is intended to assist trained professionals in the viewing, analysis and diagnostic interpretation of images and other information for the diagnosis and treatment of cardiac and vascular disease. These trained professionals include but are not limited to physicians, cardiologists, radiologists, nurses, medical technicians and assistants. Centricity Cardio Imaging is not intended for use in the patient vicinity. ","Software Version: 5.0",".","1 unit","GE Healthcare is aware of a potential safety risk where an image labeling situation exists in the Image Viewer software of the Centricity Cardio Imaging product, version 5.0 SP1. Multiple studies may be displayed side by side by selecting ''Compare Study'' from the Study List, or by opening prior studies in the Patient Folder. In these cases, the Viewer differentiates the studies wityh a label (Current, Prior or Baseline), with a border color, and with Study Date anotation. The newest study is labeled ''Current'', the next newest study is labeled ''Prior'', and if there are 3 or more studies open the oldest study is labeled ''Baseline''. When viewing multiple studies simultaneously, the border color and ''Current''/''Prior''/''Baseline'' labeling may be incorrect.",10/2/2012,"10/02/2012",10/30/2013,"10/30/2013"
"Food",64788,"Ongoing","Rich Products Corp","Buffalo","NY","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Nationwide","F-1370-2013","Class I","Farm Rich Better For You Pizza Dippers-Pizza Dough Stuffed with Reduced Fat Mozzarella Cheese, Net Wt 25-LBS (5 X 5-LB), UPC Code 10041322652338, Product Code 65233. ","Julian Dates 15821182 to 15823088; Best By Dates January 1, 2013 - September 29, 2013",,"12,687 cases","Products potentially contaminated with E. coli O121. ",3/28/2013,"03/28/2013",5/8/2013,"05/08/2013"
"Food",64788,"Ongoing","Rich Products Corp","Buffalo","NY","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Nationwide","F-1368-2013","Class I","Farm Rich Stuffed Crust Pizza Dippers-Pizza Dough Stuffed with Mozzarella Cheese, Net Wt. 27-LBS (10 X 2.7-LB), UPC Code 10041322652659, Product Code 65265; Net Wt. 25-LB (1 X 25-LB) UPC Code 10041322652680, Product Code 65268.","Julian Dates 15821182 to 15823088; Best By Dates January 1, 2013 - September 29, 2013",,"21,874 cases (product code 65265), 185,646 cases ( product code 65268)","Products potentially contaminated with E. coli O121. ",3/28/2013,"03/28/2013",5/8/2013,"05/08/2013"
"Food",64788,"Ongoing","Rich Products Corp","Buffalo","NY","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Nationwide","F-1369-2013","Class I","Farm Rich Better For You Pizza Dippers-Pizza Dough made with Whole Wheat Flour and Stuffed with Mozzarella Cheese and Reduced Fat Mozzarella Cheese, Net Wt. 27-LBS (10 X 2.7-LB), UPC Code 00041322652782, Product Code 65278.","Julian Dates 15821182 to 15823088; Best By Dates January 1, 2013 - September 29, 2013",,"15,273 cases","Products potentially contaminated with E. coli O121. ",3/28/2013,"03/28/2013",5/8/2013,"05/08/2013"
"Food",64788,"Ongoing","Rich Products Corp","Buffalo","NY","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Nationwide","F-1367-2013","Class I","Mozzarella Bites distributed under the following labels: Farm Rich Cheese In a Pizzeria Style Crust, Product Code 36450 Net Wt. 22-oz bag-UPC Code 0 41322 37443 1; Product Code 37443 Net Wt. 22-oz bag-UPC Code 0 41322 37443 1; Product Code 37433 Net Wt. 22-oz bag-UPC Code 0 41322 37813 2; Product Code 37691 Net Wt. 7-oz cartons-UPC Code 0 41322 37691 6; Product Code 32521 and 32522; Net Wt. 44-oz cartons-UPC 0 41322 32521 1; Product Code 37455 Net Wt. 2 lb. cartons-UPC Code 0 41322 37455 4, Market Day, Net Wt.. 22-oz cartons-UPC Code 0 41322 80435 8, Product Code 80435; Schwan's Baked Mozzarella Bites Net Wt.. 22 oz bags- UPC Code 0 72180 61008 9, Product Code 61008, the production date range for these products is 3G1182XXXX - 3G3088XXXX. ","Julian Dates 15821182 to 15823088; Best By Dates January 1, 2013 - September 29, 2013",,"820,577 cases","Products potentially contaminated with E. coli O121. ",3/28/2013,"03/28/2013",5/8/2013,"05/08/2013"
"Devices",64789,"Ongoing","GE Healthcare It","Barrington","IL","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution - US Distribution including the states of OH, NY, GA, TX, TN and MN and the countries of Australia, Qatar and England","Z-1585-2013","Class II","The Centricity Laboratory System is intended to be an information system designed to support the clinical and administrative activities associated with the provision and utilization of clinical laboratory services and facilities, e.g., the storing and delivering of analytical results. It is a specially designed data program application (software), which is supplied for installation in existing mainframe or decentralized computers or a computer network. This software system will not be the software directly used to run, steer, or control any specific laboratory analyzer or equipment. It is intended for use in laboratory facilities, including a central laboratory or in a multiple laboratory environment servicing satellite laboratories, reference laboratories, clinics, etc. Centricity Laboratory System is not intended for direct patient contact. ","Software Versions 3.3, 4.0, and 4.1 ",,"9 Units","If environment variables MICRO_CORRECT_MSG_TYPE and CORRECT_MSG_TYPE are set to different values, in Microbiology result entry when released results (Final Report released) are changed and the Corrected Result messages are edited on the free-text form, some of the originally entered panel free-text is lost. For this issue to occur the original result must be amended and the environmental variables set to different values.",11/20/2012,"11/20/2012",7/3/2013,"07/03/2013"
"Devices",64790,"Ongoing","Alere San Diego, Inc.","San Diego","CA","US","Voluntary: Firm Initiated","Letter","Nationwide Distribution including TN, WA, UT, KS, KY, MN, GA, MA, PA, NY, VT, and the Dist. of Columbia","Z-1148-2013","Class III","IMO-402 Mononucleosis Rapid Test Device (Whole Blood/Serum/Plasma). Catalog #IMO-402/94201 The MONO test (Whole Blood) is a rapid chromatographic immunoassay for the qualitative detection of Infectious Mononucleosis heterophile antibodies in whole blood to aid in the diagnosis of infectious Mononucleosis.","The affected control lot number is 11030386. Lot/Unit Codes: MON1040008 & MON1040016.",".","78 kits","Alere San Diego is recalling the Clearview Mononucleosis Cassette because the positive control included in the rapid test may produce false negative results.",2/26/2013,"02/26/2013",4/24/2013,"04/24/2013"
"Drugs",64792,"Ongoing","Hospira Inc.","Lake Forest","IL","US","Voluntary: Firm Initiated","Press Release","Nationwide","D-836-2013","Class I","0.9% Sodium Chloride Injection, USP, 1000 mL flexible container, Rx only, Hospira, Inc., Lake Forest, IL 60045, NDC 0409-7983-09.","Lot #: 25-037-JT*, Exp 1JAN2015, Note: the lot number may be followed by 01 or 90",".","691,356 containers","Presence of Particulate Matter: reports of small grey/brown particles found in the primary container identified as brass particulates",3/29/2013,"03/29/2013",8/14/2013,"08/14/2013"
"Food",64793,"Ongoing","DPI Specialty Foods West, Inc.","Ontario","CA","US","Voluntary: Firm Initiated","E-Mail","Distributed within the state of California.","F-1318-2013","Class III","Humboldt Fog (brand) Cypress Grove Chevre, Aged Goat Milk Cheese. Packaged in 7oz (random weight) and 5 oz (random weight). Cypress Grove Chevre # 213146 7oz (random weight) Cypress Grove Chevre # 35363 5oz (random weight) Products are random (various) weight. The 7 oz is packed 6 packs per case. The 5 oz is packed 8 packs per case.","The sell by dates on the product are between 12/14/12 and 04/28/13. Item numbers: 35363 (5 oz) and 213146 (7 oz) LOT #s 24694 24519 24521 24969 24709 25198 25108 25455 25229 23986 25701 27477 25616 25959 28278 27694 27798 25958 26444 26279 26555 26457 28345 26771 26911 26815 26931 26895 27140 26659 29345 27474 29451 29509 27865 29866 28435 28599 28429 28828 28974 29048 29350 28973 ",".","2116 cases","DPI Specialty Foods has been notified that some Cypress Grove Humboldt Fog Goat Cheese was labeled with incorrect ingredients. This product is produced with pasteurized goat milk, and was labeled as containing cultured raw cow's milk. ",3/29/2013,"03/29/2013",4/24/2013,"04/24/2013"
"Drugs",64794,"Ongoing","Legacy Pharmaceutical Packaging LLC","Earth City","MO","US","Voluntary: Firm Initiated","Letter","Distribution was made to IN.","D-580-2013","Class III","Lorazepam, 0.5 mg tablets, 100 count, RX only, Distributed by Major Pharmaceuticals, Livonia, MI. NDC 0904-6007-60","L-04009 Exp.11/15",".","1,644 bottles","Labeling: Incorrect or Missing Lot and/or Exp Date: Lorazepam Lot # L-04009 ",3/27/2013,"03/27/2013",6/12/2013,"06/12/2013"
"Biologics",64797,"Terminated","American National Red Cross The","Pomona","CA","US","Voluntary: Firm Initiated","FAX","California","B-1599-13","Class II","Platelets Pheresis Leukocytes Reduced Irradiated","07FT49462 Part A; 07FT49462 Part B; 07FT49462 Part C; ",,"3","Blood products, which were labeled as leukoreduced, but exceeded the White Blood Cell count limit, were distributed.",2/26/2013,"02/26/2013",6/26/2013,"06/26/2013"
"Food",64798,"Ongoing","Tristar Food Wholesale Co Inc","Jersey City","NJ","US","Voluntary: Firm Initiated","Telephone","New York","F-1322-2013","Class II","Fructus Lycii (400g). Dried Medlar (Net Wt: 14.11 oz (400G). Ingredients: Dried Medlar. Distributed Exclusively By: Tristar Food Wholesale Company Inc. 115 Amity Street, Jersey City NJ 07304, USA. Product of P.R.C. UPC: 6931653102466","Item #: 60025 - Dried Medlar (Net Wt: 14.11 oz (400G). UPC: 6931653102466",".","19 cartons (each carton containst 50 400 g plastic bags)","The product contains undeclared sulfites (as a preservative).",3/27/2013,"03/27/2013",4/24/2013,"04/24/2013"
"Biologics",64799,"Terminated","University Of Miami Miller School of Medicine Tissue Bank","Miami","FL","US","Voluntary: Firm Initiated","Letter","Wisconsin; Florida","B-1433-13","Class III","Bone","0090330081; 0090330080",".","2 allografts","HCT/P allografts, mislabeled with an incorrect expiration date, were distributed. ",11/12/2010,"11/12/2010",5/15/2013,"05/15/2013"
"Devices",64800,"Ongoing","Medtox Diagnostics Inc","Burlington","NC","US","Voluntary: Firm Initiated","Letter","Worldwide distribution: USA (nationwide) and in the country of: Canada.","Z-1329-2013","Class II","PROFILE-V MEDTOXScan Drugs of Abuse Test System. For the rapid, qualitative detection of drugs of abuse in human urine, ","Part No. 604018 - Lot No. 6821, 6822, 6823, 6824, 6825, 6831, 6832, 6841, 6851, 6852, 6853, 6861, 6862, 6863, 6864, 6865, 6866, 6867, 6868, 6871, 6881, 6891, 6892, 6901, 6902, 6903, 6904, 6911, 6912, 6921, 6922, 6931, 6942; Part No. 604019 - Lot No. 6321, 6331, 6341, 6351; Part No. 604020 - Lot No. 6361, 6371; Part No. 604022 - Lot No. 6551, 6552, 6561, 6562, 6563, 6564, 6571, 6581, 6582, 6583, 6584, 6591, 6592, 6593, 6601, 6602, 6603, 6611, 6612, 6621, 6622, 6623, 6631, 6632, 6641, 6651, 6652, 6661, 6671, 6672, 6681; Part No. 604026 - Lot No. 6041, 6051; Part No. 604028 - Lot No. 6051, 6061, 6071, 6081, 6091, ",,"221,625","Review of validation information and customer complaints which indicated preliminary screen positive results for cocaine that were not positive on confirmatory testing.",4/5/2013,"04/05/2013",5/22/2013,"05/22/2013"
"Food",64801,"Ongoing","ShanTea LLC","Mount Laurel","NJ","US","Voluntary: Firm Initiated","E-Mail","Arizona, Califorina, Florida, Illinois, Maryland, New Jersey, New York, Ohio, Oklahoma, Pennsylvania, Virginia, Wisconsin,","F1306-2013","Class II","ShanTea Ride The Dragon Honeybush/Licorice (UPC 794504283808) USDA Organic.","Lot 1354",,"97 cases","This recall has been initiated due to the potential for the possibility of Salmonella contamination.",3/6/2013,"03/06/2013",4/17/2013,"04/17/2013"
"Food",64801,"Ongoing","ShanTea LLC","Mount Laurel","NJ","US","Voluntary: Firm Initiated","E-Mail","Arizona, Califorina, Florida, Illinois, Maryland, New Jersey, New York, Ohio, Oklahoma, Pennsylvania, Virginia, Wisconsin,","F-1305-2013","Class II","ShanTea Enlightened Mind Mate/Kukicha (UPC 794504284102) USDA Organic.","Lot 1354",,"111 cases ","This recall has been initiated due to the potential for the possibility of Salmonella contamination.",3/6/2013,"03/06/2013",4/17/2013,"04/17/2013"
"Food",64802,"Ongoing","Red Eagle Enterprises","Surprise","AZ","US","Voluntary: Firm Initiated","Letter","AZ","F-1311-2013","Class II","Small Flour Gorditas, one dozen, net wt. 24 oz","No Lot codes, UPC 46847 77781",,"9,258 units","Red Eagle Enterprises is recalling Red Eagle Brand Flour tortilla products because they contain undeclared wheat.",3/27/2013,"03/27/2013",4/17/2013,"04/17/2013"
"Food",64802,"Ongoing","Red Eagle Enterprises","Surprise","AZ","US","Voluntary: Firm Initiated","Letter","AZ","F-1310-2013","Class II","Lite Thin Tortillas, one dozen., net wt. 15 oz","No Lot codes, UPC 46847 77780",,"8,322 units","Red Eagle Enterprises is recalling Red Eagle Brand Flour tortilla products because they contain undeclared wheat.",3/27/2013,"03/27/2013",4/17/2013,"04/17/2013"
"Food",64802,"Ongoing","Red Eagle Enterprises","Surprise","AZ","US","Voluntary: Firm Initiated","Letter","AZ","F-1309-2013","Class II","Large Cheese Crisp & Burrito Size, one dozen, net wt. 30 oz","No Lot codes, UPC 46847 77782",,"6,499 units","Red Eagle Enterprises is recalling Red Eagle Brand Flour tortilla products because they contain undeclared wheat.",3/27/2013,"03/27/2013",4/17/2013,"04/17/2013"
"Devices",64803,"Ongoing","Shimadzu Medical Systems","Torrance","CA","US","Voluntary: Firm Initiated","Letter","US Nationwide Distribution","Z-1369-2013","Class II","Shimadzu Corporation - Mobile DaRt Evolution This device is a mobile X-ray system in order to take general radiography of patients in the hospital who cannot move and/or of out patients in emergency .","In combination with CXDI-70C: Serial Numbers: 410001F0A004 410001B13012 410001B13016 410001F0A005 410001B1300E 410001B13010 0162S67303 410001B13018 410001B1300A 410001B13017 410001B1301B 410001B1301A 410001B13019 410001B1301D 410001B13011 410001B1301C 410001B13001 410001B13015 410001F0B004 410001B13008 410001B13013 410001F0B005 410001F0B006 410001F0A007 410001B13009 410001B1300B 410001B15035 410001B13014 410001B14009 410001B1301F 410001B14002 410001B14001 410001B14006 410001B14004 410001B15005 410001B13002 410001B1301E 410001B15016 410001B15009 410001B15007 410001B15006 410001B1300F 410001B15001 410001B15017 410001B15002 410001B15020 In combination with CXDI-55C: Serial Numbers: 0162S65805 0162S65810 0162S65808 0162S66001 0162S66008 0162S65809 0162S66004 0162S66005 0162S66009 0162S66010 0162S66201 0162S66202 0162S66207 0162S66208 0162S66206 0162S66302 0162S66402 0162S66409 0162S66410 0162S66403 0162S66501 0162S66405 0162S66407 0162S66406 0162S66505 0162S66502 0162S66503 0162S66408 0162S66504 0162S66603 0162S66508 0162S66507 0162S66510 0162S66709 0162S66601 0162S66610 0162S66609 0162S66605 In combination with CXDI-55G Serial Numbers: 0162S66205 0162S66307 0162S66309 0162S65901 0162S66003 0162S66306 0162S66308 0162S66509 0162S65709 0162S66606 0162S66802 0162S66803",".","103 units","The recall was initiated because Shimadzu Corporation has identified a potential issue in certain manufacturing lots of the Shimadzu MobileDaRt Evolution in combination with CXDI-70C, CXDI-55C, and CXDI-55G. As a result of Shimadzu's investigation, there is a potential risk for screws becoming loose inside the Shimadzu Mobile X-ray systems.",3/18/2013,"03/18/2013",6/12/2013,"06/12/2013"
"Devices",64804,"Completed","GE Healthcare, LLC","Waukesha","WI","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution - USA including GA, and NY; and countries of: Canada, Israel, Italy and Switzerland.","Z-1164-2013","Class II","GE Healthcare, Xeleris 2 Processing & Review Workstation. The display, processing, archiving, and communication of data acquired by Emission Tomography cameras used in diagnostic radiology, including procedures for planar imaging, whole body imaging, tomographic (SPECT) imaging, positron imaging by coincidence, attenuation correction, and anatomical image registration","Mfg Lot or Serial # 0000CZC7105FJM000 00000CZC827NRN000 00000CZC8283V4000 0000CZC8283V47000 0000CZC8283V72001 0000CZC8283TX5001 00000000211423001 0000CZC8161XJT000 0000CZC94154WV003 0000CZC83942HL000 0000CZC8396CC9001 ",".","11","GE Healthcare has become aware of a software issue in your Xeleris 2.1 workstation (that is used for processing Discovery 530/570 data), that may impact patient safety. On imported CT scans, Myocardial Perfusion Imaging (MPI) studies may create artifacts in attenuation corrected images. This may lead to a potential for misdiagnosis.",10/6/2011,"10/06/2011",5/1/2013,"05/01/2013"
"Devices",64805,"Ongoing","GE Healthcare It","Barrington","IL","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution - USA (nationwide) including Puerto Rico and the countries of: Australia, Canada, Denmark, Germany, Hong Kong, Korea, South Korea, Thailand and United Kingdom.","Z-0337-2014","Class II","Centricity Perinatal and Centricity Intensive Care is intended to be used in clinical departments healthcare delivery systems such as a Labor and Delivery, Postpartum Maternal Care, newborn Nursery, critical care units including Neonatal Intensive Care Units (NICU), and may also be used in physicians offices and outpatient clinics. This product is primarily intended to serve the purpose of electronic documentation of clinical data and is designed to accept, transfer, display, calculate, store and manage clinical data. System capabilities provide the user with the ability to acquire data from the medical devices and to document, annotate, display, store, print, export and retrieve patient clinical practice information. This product is intended for professional use only.","Centricity Perinatal and Centricity Intensive Care Versions: 6.60, 6.60.9, 6.70.0, 6.70.1, 6.70.5, 6.70.6, 6.80.0, 6.80.1, 6.90.0, 6.90.1, 6.91.1",,"1,132 units","1) Under rare network conditions, a Centricity Perinatal process may maintain an incorrect count of Patient slots in use which may lead to an inability to access the patient roster. The user is temporarily unable to review or edit form and chart information. This could result in a potential delay of care; however active fetal strips and permanent patient data storage are not affected. 2) When patient data on a vertical chart exceeds one page (with more rows then can fit on a page), the thumb indicator (Right Scroll Bar) appears to be at the end of the page when there may be more data. Because this information is not viewed, the clinician may not take the data into account when making a clinical decision. However, the bottom right corner of the chart box is displayed when you reach the end of a vertical chart as a visual cue. 3) It is possible for a system manager to misconfigure a coded or multi-coded item with no short text defined. This may have the effect of not presenting the data on the tubular chart display even if the data is set to show long text values. The clinician may not be aware this data exists and therefore may not take into account during clinical decision making. 4) If using a Phillips physiological monitor (not fetal monitor) at a patient's bedside, and data still exists on the monitor from the previous patient, and the clinician selects the ''acquire vital signs'' action from the Centricity Perinatal system before the initial vital signs are actually taken on the new patient, the monitor buffer sends the last set of vital signs from the previous patient. This data may be stored in the patient record if vital signs do not need to be validated. If this incorrect data is stored to the patient record the clinician may use this data in clinical decision making. 5) The Centricity Perinatal server process (PTD) that manages scheduled tasks may be misconfigured and saved with undefined patient selection criteria. When the criterion for a PTD job is undefined (selected patient or sele",3/11/2013,"03/11/2013",11/27/2013,"11/27/2013"
"Devices",64806,"Ongoing","GE Healthcare It","Barrington","IL","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution - USA (nationwide) including GA and Internationally to Canada and the United Kingdom.","Z-0330-2014","Class II","The Centricity Laboratory System is intended to be an information system designed to support the clinical and administrative activities associated with the provision and utilization of clinical laboratory services and facilities, e.g., the storing and delivering of analytical results. It is a specially designed data program application (software), which is supplied for installation in existing mainframe or decentralized computers or a computer network. This software system will not be the software directly used to run, steer, or control any specific laboratory analyzer or equipment. It is intended for use in laboratory facilities, including a central laboratory or in a multiple laboratory environment servicing satellite laboratories, reference laboratories, clinics, etc. Centricity Laboratory System is not intended for direct patient contact. The Centricity Laboratory System product is designed to facilitate the general clinical, anatomic pathology and cytology laboratory workflow such as order entry, results entry, instrument interfacing, results reporting and patient record retrieval. It integrates with other Hospital Information Systems (HIS) through HL7 interface by order entering and also report processing. The Centricity Laboratory System is intended to interface with various lab results. Centricity Laboratory System is intended to be used by laboratory technologists, technicians, analyst and other trained/site authorized system users ","Software Versions: 3.3, 4.0, 4.1",,"7 units","GE Healthcare has become aware of a potential safety issue associated with the use of GE Centricity Laboratory where panel reflex does not occur if DIP.Specimen is blank. Panel reflexing fails to occur when ad-hoc re-routing functionality is used and the following are true: 1) The ordered panel is a slave panel, and; 2) The panitem specimen group field of one or more of the ordered items on the master panel is blank instead of null or the panitem specimen group field of one or more of the ordered items on another re-route master panel on the same request is blank instead of null, and; 3) The re-routed batches containing the affected master panels are recieved at the performing lab before the item causing the reflex is resulted.",3/12/2013,"03/12/2013",11/27/2013,"11/27/2013"
"Devices",64808,"Ongoing","Siemens Healthcare Diagnostics, Inc.","Newark","DE","US","Voluntary: Firm Initiated","Letter","Worldwide distribution: US (nationwide) including sates of: AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, IL, ID, KY, KS, LA, MA, MD, MI, MN, MO, MS, MT, PA, NC, NE, NH, NJ, NY, OH, PA, SC, TN, TX, UT, VA, VT, WA, WI, WV, and PR; and country of: UK.","Z-0017-2014","Class II","Dimension Vista (R) Urinary/Cerebrospinal Fluid Protein (UCFP) Flex (R) Reagent Cartridge Lot 11349BB The Urinary / Cerebrospinal Fluid Protein method is an in vitro diagnostic test for the quantitive measurement of protein in urine and cerebrospinal fluid on the Dimension Vista System.","Lot No. 11349BB",,"3395","Siemens has confirmed an increase on absorbance errors when calibrating Dimension Vista Urinary/Cerebrospinal Fluid Protein (U CFP) Flex Reagent Cartridge lot 11349 BB.",12/19/2012,"12/19/2012",10/23/2013,"10/23/2013"
"Devices",64809,"Ongoing","Accuray Incorporated","Sunnyvale","CA","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution - USA Nationwide including the states of: OH, MO. OK, CA and VA and the countries of: Finland, France, Luxembourg, Poland, Russia, Turkey and Japan.","Z-1155-2013","Class II","RoboCouch Patient Positioning System Product Usage: is intended for use in the support and positioning of a patient during radiosurgery and radiotherapy procedures and other medical procedures when precise positioning is required. ","Model number: 025007",".","16 devices are subject to correction.","A5 gearboxes responsible for pitch (head up and head down) and roll (patient left and right) motions of the RoboCouch manipulator may be defective.",3/27/2013,"03/27/2013",5/1/2013,"05/01/2013"
"Devices",64810,"Ongoing","Synvasive Technology Inc","El Dorado Hills","CA","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution - USA (nationwide) and countries of: Austria, Australia, Belgium, Czech Republic, Denmark, Finland, France, Germany, Italy, Japan, Netherlands, Norway, Panama, Spain, Sweden, Switzerland, Tunisia, United Kingdom and Yemen.","Z-1115-2013","Class II","Product is distributed by Zimmer (Warsaw, Indiana)/Synvasive Technology, Inc. (El Dorado Hills, CA) & manufactured under Synvasive Technology, Inc. El Dorado Hills, CA Reciprocating saw blade: A sterile surgical saw blade used to resect damaged cartilage and/or bond in an orthopaedic reconstructive procedure such as a total knee replacement. ","Lots Numbers included in Recall: 1X311,01251,16325,15023,15024,1Y224,23326,0X401,26385,1Y174, 17151,0Y280,17150,22028,28114,19071,23372,23346,23504,23505, 25134,25341,2W223,2X105,26001,2W573,2W574,24348,25304, 25333,26068,26165,27015,27016,29392,PD4647 ",".","3442 units per the part numbers listed","Various reciprocating and oscillating saw blades were incorrectly labeled. The labeling errors include: (1) The pouch says oscillating saw blade when it actually contains a reciprocating saw blade; (2) The box bar code date does not match the human readable expiration date; and (3) The label incorrectly states use with Zimmer/Synthes handset and not the Zimmer Universal Power System.",4/2/2013,"04/02/2013",4/24/2013,"04/24/2013"
"Veterinary",64811,"Completed","Cargill Animal Nutrition","Burlington","WA","US","Voluntary: Firm Initiated","Telephone","Product was distributed to retail feed stores located in WA and ID.","V-301-2013","Class I","Showmaster S-Series Show Lamb Feed (BW). Cargill Animal Nutrition, General Office, Minneapolis, MN 55440. UPC 7 22304 28992 8 50 lb bag","38306326464, 38306726610, and 38307426757 Lot code consists of four components: 38 - 3 - 063 - 26464 38= location code 38 = Burlington, WA 3 = year (2013) 063 = julian date code (63rd day of the year = March 4th) 26464 = represents the production run and is sequential run number from the batching system and matches up to the production records.",,"620 - 50 lb bags","The animal feed was manufactured with the incorrect concentration of sodium molybdate (molybdenum) thereby having an excessive amount of molybdenum.",3/28/2013,"03/28/2013",9/4/2013,"09/04/2013"
"Devices",64812,"Ongoing","Masimo Corporation","Irvine","CA","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution - USA (nationwide) including the countries of Africa, Asia, Australia/New Zealand, Europe, Canada, Latin America, and Middle East / SW Asia.","Z-1187-2013","Class II","Rad-8 Pulse Oximeters The Rad-8 family of pulse oximeters and accessories are indicated for the continuous, noninvasive monitoring of functional oxygen saturation of arterial hemoglobin (SpO2) and pulse rate (measured by an SpO2 sensor). ","Catalog Number 9190 9193 9191 9192 9212 9213 9218 9219 9224 9282 9285 2883 9194 ",,"42,908 units","Masimo has identified a very small number (0.02%) of Rad-8 devices with 20-pin patient cable connector that, when moved, can power off without the operator pressing the power button. ",3/13/2013,"03/13/2013",5/8/2013,"05/08/2013"
"Food",64813,"Ongoing","All One, Inc.","San Clemente","CA","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Nationwide including: AK, AL, AR, AZ, CA, CO, FL, GA, HI, IN, KY, KS, LA, ME, MD, MI, MO, MS, NC, NJ, NM, NE, NV, NY, OH, OK, OR, PA, SC, TN, TX, UT, VA, WA, WI and WY.","F-1339-2013","Class II","all One Active Senior Multiple Vitamin & Mineral Powder dietary supplement, 30 Day Supply, 15.9 oz. canisters","UPC: 0 52534 40008 5, Lot No. 170502, Use By: 01/15.",".","796 units","Product label misprinted to include claim of ''No Dairy'', even though milk is present in an ingredient (whey protein isolate). ''Certified Vegan'' is also claimed on the product label. The Supplement Facts panel and side panel discusses the presence of milk in the product.",3/28/2013,"03/28/2013",5/1/2013,"05/01/2013"
"Food",64813,"Ongoing","All One, Inc.","San Clemente","CA","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Nationwide including: AK, AL, AR, AZ, CA, CO, FL, GA, HI, IN, KY, KS, LA, ME, MD, MI, MO, MS, NC, NJ, NM, NE, NV, NY, OH, OK, OR, PA, SC, TN, TX, UT, VA, WA, WI and WY.","F-1340-2013","Class II","all One Original Formula Multiple Vitamin & Mineral Powder dietary supplement, 30 Day Supply, 15.9 oz. canisters","UPC: 0 52534 20001 2, Lot No. 172801, Use By: 10/14.",".","1,205 units","Product label misprinted to include claim of ''No Dairy'', even though milk is present in an ingredient (calcium caseinate). ''Certified Vegan'' is also claimed on the product label. The side panel discusses the presence of milk in the product.",3/28/2013,"03/28/2013",5/1/2013,"05/01/2013"
"Biologics",64814,"Terminated","The Blood Alliance, Inc.","Jacksonville","FL","US","Voluntary: Firm Initiated","E-Mail","Switzerland","B-1600-13","Class II","Blood and Blood Products for Reprocessing","W118812253912; ",,"1","Blood product, collected from a donor who was at risk for variant Creutzfeldt-Jakob disease (vCJD), was distributed.",3/4/2013,"03/04/2013",6/26/2013,"06/26/2013"
"Biologics",64815,"Terminated","The American National Red Cross - Southern Region","Douglasville","GA","US","Voluntary: Firm Initiated","FAX","Georgia","B-1447-13","Class II","Red Blood Cells Leukocytes Reduced","003LH34364",".","1 unit","Blood product, misbranded as Jkb negative, and subsequently determined to be JKb positive, was distributed. ",2/12/2013,"02/12/2013",5/15/2013,"05/15/2013"
"Biologics",64816,"Terminated","Northern Illinois Blood Bank dba Rock River Valley BC","Rockford","IL","US","Voluntary: Firm Initiated","Telephone","Illinois","B-1601-13","Class II","Platelets Pheresis Leukocytes Reduced","W044413301228; ",,"1","Blood product, which did not meet acceptable product specifications, was distributed.",2/21/2013,"02/21/2013",6/26/2013,"06/26/2013"
"Biologics",64817,"Terminated","Community Blood Centers of South Florida, Inc.","Hialeah","FL","US","Voluntary: Firm Initiated","Telephone","Florida","B-1603-13","Class II","Red Blood Cells","W036812482900; ",,"1","Blood products, collected from a donor for whom donor suitability was not adequately determined, were distributed",2/25/2013,"02/25/2013",6/26/2013,"06/26/2013"
"Biologics",64817,"Terminated","Community Blood Centers of South Florida, Inc.","Hialeah","FL","US","Voluntary: Firm Initiated","Telephone","Florida","B-1602-13","Class II","Platelets Pooled Leukocytes Reduced","W036813801947; ",,"1","Blood products, collected from a donor for whom donor suitability was not adequately determined, were distributed",2/25/2013,"02/25/2013",6/26/2013,"06/26/2013"
"Biologics",64817,"Terminated","Community Blood Centers of South Florida, Inc.","Hialeah","FL","US","Voluntary: Firm Initiated","Telephone","Florida","B-1604-13","Class III","Blood and Blood Products for Reprocessing","W036812482900; ",,"1","Blood products, collected from a donor for whom donor suitability was not adequately determined, were distributed",2/25/2013,"02/25/2013",6/26/2013,"06/26/2013"
"Biologics",64818,"Terminated","OneBlood / dba CBCF","Lauderhill","FL","US","Voluntary: Firm Initiated","Letter","Florida","B-1605-13","Class II","Fresh Frozen Plasma","W036812440858; ",,"1","Blood products, collected from a donor in whom donor suitability was not adequately determined, were distributed.",2/20/2013,"02/20/2013",6/26/2013,"06/26/2013"
"Biologics",64818,"Terminated","OneBlood / dba CBCF","Lauderhill","FL","US","Voluntary: Firm Initiated","Letter","Florida","B-1606-13","Class II","Red Blood Cells Leukocytes Reduced","W036812440858; ",,"1","Blood products, collected from a donor in whom donor suitability was not adequately determined, were distributed.",2/20/2013,"02/20/2013",6/26/2013,"06/26/2013"
"Biologics",64819,"Terminated","Medic Inc","Knoxville","TN","US","Voluntary: Firm Initiated","Letter","Tennessee","B-1607-13","Class II","Red Blood Cells Leukocytes Reduced","W071212042342; ",,"1","Blood product, which was collected from a donor who had traveled to an area considered endemic for malaria, was distributed.",1/2/2013,"01/02/2013",6/26/2013,"06/26/2013"
"Devices",64820,"Ongoing","NxStage Medical, Inc.","Lawrence","MA","US","Voluntary: Firm Initiated","E-Mail","Nationwide Distribution including IL, SC, TX, VA, FL, AR, and NY.","Z-1214-2013","Class II","NxStage PureFlow-B Solution, Model/Catalog Number: RFP-401, packaged in a case The NxStage PureFLow-B Solution is indicated for use with renal replacement therapy systems that utilize sterile premixed dialysate during hemodialysis.","F023444",,"1480 cases (2 bags per case)","Product may be mislabeled. ",3/18/2013,"03/18/2013",5/8/2013,"05/08/2013"
"Drugs",64821,"Ongoing","West-ward Pharmaceutical Corp.","Eatontown","NJ","US","Voluntary: Firm Initiated","Letter","Nationwide.","D-242-2013","Class II","Ethambutol Hydrochloride Tablets, USP, 100 mg, 100-count tablets per bottle, Rx only, Mfd. for: Versapharm Incorporated, Marietta, GA; Mfd. by: West-Ward Pharmaceutical Corp., Eatontown, NJ 07724; NDC 61748-011-01.","Lot #: 68028A, Exp 07/14",".","3, 061 bottles","Subpotent Drug: Out Of Specification results for assay at the stability time-point of 24 months.",3/18/2013,"03/18/2013",4/10/2013,"04/10/2013"
"Food",64822,"Ongoing","Planet Food","Los Angeles","CA","US","Voluntary: Firm Initiated","E-Mail","TX","F-1352-2013","Class III","Yum Nature Tahini, Net Wt. 18oz (1lb.2oz.)510g,12 jars/case","UPC 0 56664 02206 3 Lot# RSMTM0312",".","675 cases","Planet Food is recalling Yum Nature Tahini because it has the potential to be contaminated with Salmonella.",4/1/2013,"04/01/2013",5/1/2013,"05/01/2013"
"Biologics",64824,"Terminated","University of Miami Miller School of Medicine Tissue Bank","Miami","FL","US","Voluntary: Firm Initiated","Letter","Nationwide, including Puerto Rico. Countries: South Korea and Greece.","B-0159-14","Class II","Bone","UDM0089550031; UDM0089550032; UDM0089550033; UDM0089550034; UDM0089550035; UDM0089550037 ",,"6 lots of tissue from donors","Human tissue allografts, whose donor eligibilities were not determined by using appropriate FDA-licensed, approved, or cleared donor screening tests, in accordance with the manufacturer's instructions, to adequately and appropriately reduce the risk of transmission of relevant communicable disease agents or diseases, were distributed. ",3/24/2013,"03/24/2013",12/18/2013,"12/18/2013"
"Biologics",64824,"Terminated","University of Miami Miller School of Medicine Tissue Bank","Miami","FL","US","Voluntary: Firm Initiated","Letter","Nationwide, including Puerto Rico. Countries: South Korea and Greece.","B-0156-14","Class II","Bone","UBO0089550057; UBO0089550058; UBO0090690078 ",,"3 lots of tissue from donors","Human tissue allografts, whose donor eligibilities were not determined by using appropriate FDA-licensed, approved, or cleared donor screening tests, in accordance with the manufacturer's instructions, to adequately and appropriately reduce the risk of transmission of relevant communicable disease agents or diseases, were distributed. ",3/24/2013,"03/24/2013",12/18/2013,"12/18/2013"
"Biologics",64824,"Terminated","University of Miami Miller School of Medicine Tissue Bank","Miami","FL","US","Voluntary: Firm Initiated","Letter","Nationwide, including Puerto Rico. Countries: South Korea and Greece.","B-0158-14","Class II","Bone","USK0090690038; USK0090690039; USK0090690040; USK0090690041 ",,"4 lots of tissue from donors","Human tissue allografts, whose donor eligibilities were not determined by using appropriate FDA-licensed, approved, or cleared donor screening tests, in accordance with the manufacturer's instructions, to adequately and appropriately reduce the risk of transmission of relevant communicable disease agents or diseases, were distributed. ",3/24/2013,"03/24/2013",12/18/2013,"12/18/2013"
"Biologics",64824,"Terminated","University of Miami Miller School of Medicine Tissue Bank","Miami","FL","US","Voluntary: Firm Initiated","Letter","Nationwide, including Puerto Rico. Countries: South Korea and Greece.","B-0155-14","Class II","Bone","UBI0090690110; UBI0090690111; UBI0090690112; UBI0090690113; UBI0090690116; UBI0090690117; UBI0090690118; UBI0090690119; UBI0090690120; UBI0090690121; UBI0090690122; UBI0090690123; UBI0090690124; UBI0090690126; UBI0090690127; UBI0090690128; UBI0090690129; UBI0090690131; UBI0090690132; UBI0090690133; UBI0090690134; UBI0090690135; UBI0090690136; UBI0090690137; UBI0090690138; UBI0090690139; UBI0090690140; UBI0090690141; UBI0090690142; UBI0090690144; UBI0090690145; UBI0090690146; UBI0090690147; UBI0090690148; UBI0090690149; UBI0090690150; UBI0090690151; UBI0090690152; UBI0090690153; UBI0090690154; UBI0090690156; UBI0090690157; UBI0090690158; UBI0090690159; UBI0090690160; UBI0090690161; UBI0090690162; UBI0090690163; UBI0090690165; UBI0090690166; UBI0090690167; UBI0090690168; UBI0090690169; UBI0090690170; UBI0090690171; UBI0090690172; UBI0090690173; UBI0090690174; UBI0090690175; UBI0090690176; UBI0090690177; UBI0090690178; UBI0090690179; UBI0090690180; UBI0090690181; UBI0090690182; UBI0090690183; UBI0090690184; UBI0090690185; UBI0090690186; UBI0090690187; UBI0090690188; UBI0090690189; UBI0090690195; UBI0090690196; UBI0090690197; UBI0090690198; UBI0090690199; UBO0089550077; UBO0089550078; UBO0089550079; UBO0089550080; UBO0090690086; UBO0090690087; UBO0090690088; UBO0090690089; UBO0090690090; UBO0090690091; UBO0090690092; UBO0090690093; UBO0090690094; UBO0090690099; UBO0090690100; UBO0090690101; UBO0090690102; UBO0090690105; UBO0090690106; UBO0090690107; UBO0090690108; UBO0090690109; UBO0090690200; UBO0090690201; UBO0090690202; UBO0090690203; UBO0090690204; UBO0090690205; UBO0090690206; UBO0090690207; UBO0090690208; UBO0090690209; UBO0090690210; UBO0090690211; UBO0090690212; UBO0090690213; UBO0090690216; UBO0090690217; UBO0090690218; UBO0090690219; UBO0090690220; UBO0090690221; UBO0090690222; UBO0090690223; UBO0090690224; UBO0090690225; UBO0090690226; UBO0090690227; UBO0090690228; UBO0090690229; UBO0090690230; UBO0090690231; UBO0090690232; UBO0090690233; UBO0090690234; UBO0090690235; UBO0090690236; UBO0090690237; UBO00",,"310 allografts","Human tissue allografts, whose donor eligibilities were not determined by using appropriate FDA-licensed, approved, or cleared donor screening tests, in accordance with the manufacturer's instructions, to adequately and appropriately reduce the risk of transmission of relevant communicable disease agents or diseases, were distributed. ",3/24/2013,"03/24/2013",12/18/2013,"12/18/2013"
"Biologics",64824,"Terminated","University of Miami Miller School of Medicine Tissue Bank","Miami","FL","US","Voluntary: Firm Initiated","Letter","Nationwide, including Puerto Rico. Countries: South Korea and Greece.","B-0157-14","Class II","Bone","UBO0090690064; UBO0090690065; UBO0090690066; UBO0090690067; UBO0090690068; UBO0090690069; UBO0090690070; UBO0090690071; UBO0090690072; UBO0090690073; UBO0090690074; UBO0090690075; UBO0090690076; UBO090690077. ",,"14 lots of tissue from donors","Human tissue allografts, whose donor eligibilities were not determined by using appropriate FDA-licensed, approved, or cleared donor screening tests, in accordance with the manufacturer's instructions, to adequately and appropriately reduce the risk of transmission of relevant communicable disease agents or diseases, were distributed. ",3/24/2013,"03/24/2013",12/18/2013,"12/18/2013"
"Biologics",64825,"Terminated","University of Miami Miller School of Medicine Tissue Bank","Miami","FL","US","Voluntary: Firm Initiated","Letter","Florida","B-0152-14","Class II","Bone","UBO0082610006; UBO0082610009; UBO0082610030; UBO0082610031; UBO0082610032; UBO0082610033; UBO0082610046; UBO0089580052; UBO0089580053; UBO0089580054; UBO0089580055; UBO0089580056; UBO0089580057; UBO0089580058; UBO0089580059; UBO0082610004; UBO0082610007; UBO0082610008; UBO0082610045; UBO0089580050; UBO0089580051 ",,"21 lots of tissue from donors","Human tissue allografts, whose donor eligibilities were not determined by using appropriate FDA-licensed, approved, or cleared donor screening tests, in accordance with the manufacturer's instructions, to adequately and appropriately reduce the risk of transmission of relevant communicable disease agents or diseases, were distributed. ",3/24/2013,"03/24/2013",12/18/2013,"12/18/2013"
"Biologics",64825,"Terminated","University of Miami Miller School of Medicine Tissue Bank","Miami","FL","US","Voluntary: Firm Initiated","Letter","Florida","B-0154-14","Class II","Bone","UBO0082610038",,"1 lot of tissue from donor","Human tissue allografts, whose donor eligibilities were not determined by using appropriate FDA-licensed, approved, or cleared donor screening tests, in accordance with the manufacturer's instructions, to adequately and appropriately reduce the risk of transmission of relevant communicable disease agents or diseases, were distributed. ",3/24/2013,"03/24/2013",12/18/2013,"12/18/2013"
"Biologics",64825,"Terminated","University of Miami Miller School of Medicine Tissue Bank","Miami","FL","US","Voluntary: Firm Initiated","Letter","Florida","B-0150-14","Class II","Bone","UBO0082610001; UBO0082610002; UBO0082610003; UBO0082610005; UBO0082610010; UBO0082610011; UBO0082610012; UBO0082610013; UBO0082610014; UBO0082610015; UBO0082610016; UBO0082610020; UBO0082610021; UBO0082610022; UBO0082610023; UBO0082610024; UBO0082610028; UBO0082610029; UBO0082610034; UBO0082610035; UBO0082610036; UBO0082610037; UBO0082610039; UBO0082610040; UBO0082610041; UBO0082610042; UBO0082610043; UBO0082610044; UBO0089580080; UBO0089580081; UBO0089580082; UBO0089580084; UBO0089580085; UBO0089580086; UBO0089580087; UBO0089580094; UBO0089580094; UBO0089580095; UBO0089580096; UBO0089580097; UBO0089580098; UBO0089580099; UBO0089580100; UBO0089580101; UBO0089580102; UBO0089580103; UBO0089580105; UBO0089580106; UBO0089580107; UBO0089580109; UBO0089580110; UBO0089580111; UBO0089580112; UBO0089580113; UBO0089580114; UBO0089580115; UBO0089580119; UBO0089580120; UBO0089580121; UBO0089580122; UBO0089580123; UBO0089580124; UBO0089580125; UBO0089580126; UBO0089580127; UBO0089580128; UBO0089580129; UBO0089580130; UBO0089580131; UBO0089580132; UBO0089580133; UBO0089580134; UBO0089580135; UBO0089580136; UBO0089580137; UBO0089580138; UBO0089580139; UBO0089580141; UBO0089580142; UBO0089580143; UBO0089580144; UBO0089580145; UBO0089580146; UBO0089580147; UBO0089580148; UBO0089580149; UBO0089580150; UBO0089580151; UBO0089580152; UBO0089580153; UBO0089580154; UBO0089580155; UBO0089580156; UBO0089580157; UBO0089580158; UBO0089580159; UBO0089580160; UBO0089580161; UBO0089580162; UBO0089580163; UBO0089580164; UBO0089580165; UBO0089580166; UBO0089580167; UBO0089580168; UBO0089580169; UBO0089580170; UBO0089580171; UBO0089580172; UBO0089580173; UBO0089580174; UBO0089580175; UBO0089580176; UBO0089580177; UBO0089580178; UBO0089580179; UBO0089580180; UBO0089580181; UBO0089580182; UBO0089580183; UBO0089580184; UBO0089580185; UBO0089580186; UBO0089580187; UBO0089580188; UBO0089580189; UBO0089580190; UBO0089580191; UBO0089580192; UBO0089580193; UBO0089580194; UBO0089580195; UBO0089580196; UBO0089580197; UBO0089580198; UBO0089580199; UBO00",,"933 lots of tissue from donors","Human tissue allografts, whose donor eligibilities were not determined by using appropriate FDA-licensed, approved, or cleared donor screening tests, in accordance with the manufacturer's instructions, to adequately and appropriately reduce the risk of transmission of relevant communicable disease agents or diseases, were distributed. ",3/24/2013,"03/24/2013",12/18/2013,"12/18/2013"
"Biologics",64825,"Terminated","University of Miami Miller School of Medicine Tissue Bank","Miami","FL","US","Voluntary: Firm Initiated","Letter","Florida","B-0151-14","Class II","Bone","UBO0089580061; UBO0089580062; UBO0089580063 ",,"3 lots of tissue from donors","Human tissue allografts, whose donor eligibilities were not determined by using appropriate FDA-licensed, approved, or cleared donor screening tests, in accordance with the manufacturer's instructions, to adequately and appropriately reduce the risk of transmission of relevant communicable disease agents or diseases, were distributed. ",3/24/2013,"03/24/2013",12/18/2013,"12/18/2013"
"Biologics",64825,"Terminated","University of Miami Miller School of Medicine Tissue Bank","Miami","FL","US","Voluntary: Firm Initiated","Letter","Florida","B-0153-14","Class II","Bone","USK0056960001; USK0056960002; USK0056960003; USK0056960004; USK0056960005; USK0056960006; USK0056960007; USK0089580064; USK0089580065; USK0089580066; USK0089580067; USK0089580068; USK0089580069; USK0089580070; USK0089580071; USK0089580072; USK0089580073; USK0089580074; USK0089580075; USK0089580076. ",,"20 lots of tissue from donors","Human tissue allografts, whose donor eligibilities were not determined by using appropriate FDA-licensed, approved, or cleared donor screening tests, in accordance with the manufacturer's instructions, to adequately and appropriately reduce the risk of transmission of relevant communicable disease agents or diseases, were distributed. ",3/24/2013,"03/24/2013",12/18/2013,"12/18/2013"
"Devices",64826,"Completed","I-Flow LLC","Lake Forest","CA","US","Voluntary: Firm Initiated","E-Mail","Nationwide distribution: USA including states of: CA, CT, FL, IL, IN, KY, NY, OH, OR, TN, TX, VA and WI.","Z-1444-2013","Class II","I-Flow ON-Q Pain Relief System, T-Block Needle/Catheter Tray, Model #TBTB1089T The intended use of each component in the finished final trays is consistent with the intended use of the component stated in the respective 510(k) submission.","Lot # AW207202O",".","450 units","I-Flow initiated two voluntary product removals of the ON-Q Pain Relief System: T-Block Needle/Catheter Tray and T-Block Needle/Catheter Kit because they may have potentially malfunctioned.",6/1/2012,"06/01/2012",6/12/2013,"06/12/2013"
"Devices",64826,"Completed","I-Flow LLC","Lake Forest","CA","US","Voluntary: Firm Initiated","E-Mail","Nationwide distribution: USA including states of: CA, CT, FL, IL, IN, KY, NY, OH, OR, TN, TX, VA and WI.","Z-1445-2013","Class II","I-Flow ON-Q Pain Relief System, T-Block Needle/Catheter Kit, Model #TB089T The intended use of each component in the finished final trays is consistent with the intended use of the component stated in the respective 510(k) submission.","Lot # AW207202U",".","75 units","I-Flow initiated two voluntary product removals of the ON-Q Pain Relief System: T-Block Needle/Catheter Tray and T-Block Needle/Catheter Kit because they may have potentially malfunctioned.",6/1/2012,"06/01/2012",6/12/2013,"06/12/2013"
"Food",64827,"Completed","Centerville Pie Company, Inc.","Hyannis","MA","US","Voluntary: Firm Initiated","Telephone","MA","F-1342-2013","Class I","Centerville Pie Company Clam Pie, 2 lb (Large) and 1 lb (Small)","All codes",,"52 pies","Undeclared allergen-anchovies",4/2/2013,"04/02/2013",5/22/2013,"05/22/2013"
"Devices",64828,"Ongoing","Varian Medical Systems, Inc. Oncology Systems","Palo Alto","CA","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution - USA (Nationwide) and countries of: Australia, Austria, Bangladesh, Belgium, Brazil, Bulgaria, Canada, China, Columbia, Costa Rica, Cyprus, Czech Republic, Denmark, Dominican Republic, Estonia, Finland, France, Germany, Greece, Guatemala, Hong Kong, Hungary, India, Indonesia, Ireland, Israel, Italy, Japan, Kuwait, Latvia, Lebanon, Lithuania, Luxembourg, Macau, Malaysia, Mexico Morocco, Netherlands, New Zealand, Norway, Peru, Poland, Portugal, Qatar, Romania, Russia, Saudi Arabia, Singapore, South Korea, Spain, Sweden, Switzerland, Taiwan, Thailand, Turkey, Ukraine, United Arab E, and United Kingdom.","Z-1163-2013","Class II","Varian brand RPM Respiratory Gating System, RPM Gating v1.7.5 with 3D Option, Model Number: HS2 Product Usage: The RPM device is to be used to characterize the patients respiratory motion information to synchronize their operation with the respiratory motion. ","CODES: HS00017 HS00366 HS00611 HS00804 HS01060 HS01256 HS01451 HS01662 HS01863 HS02024 HS02215 HS02371 HS02539 HS00018 HS00371 HS00615 HS00805 HS01061 HS01260 HS01456 HS01664 HS01872 HS02035 HS02239 HS02373 HS02542 HS00025 HS00378 HS00618 HS00806 HS01062 HS01265 HSOI459 HSOI667 HSOI875 HS02040 HS02240 HS02376 HS02545 HS00026 HS00384 HS00619 HS00807 HSOI063 HSOI269 HSOI460 HSOI671 HSOI876 HS02043 HS02242 HS02377 HS02548 HS00031 HS00385 HS00624 HS00811 HSOI066 HS01270 HSOI462 HSOI674 HSOI877 HS02048 HS02245 HS02380 HS02SSI HS00032 HS00392 HS00628 HS00813 HS01069 HSOI281 HS01463 HSOI675 HSOI878 HS02053 HS02250 HS02381 HS02553 HS00035 HS00393 HS00630 HS00814 HS01071 HSOI282 HS01466 HS01676 HS01883 HS020SS HS022Sl HS02383 HS02554 HS00036 HS00396 HS00634 HSOOSIS HS01080 HS01283 HS0147l HS01678 HS01885 HS02059 HS02253 HS02384 HS02SSS HS00037 HS00398 HS00636 HS00818 HSOIOSS HS01285 HS01480 HS01685 HS01886 HS02068 HS02256 HS02389 HS02562 HS00038 HS00408 HS00638 HS00827 HS01090 HS01291 HS01489 HS01686 HS01888 HS02070 HS02262 HS02392 HS02565 HS00039 HS00410 HS00639 HS00829 HS01093 HS01296 HSOI490 HS01694 HS01889 HS02072 HS02263 HS02395 HS02566 HS00043 HS00420 HS00640 HS00843 HS01094 HS01299 HSOI498 HS01696 HS01890 HS02080 HS02267 HS02397 HS02567 h500044 HS00422 HS0064l HS008Sl HSOllOO HS01303 HS01499 HS01697 HS01893 HS02083 HS02268 HS02399 HS02569 HS00049 HS00433 HS00643 HS00856 HSOIIOS HS01307 HSOISOO HS01698 HS01895 HS02085 HS02269 HS02401 HS02573 HSOOOSO HS00434 HS00644 HS00873 HSOI106 HS01308 HSOIS03 HS01700 HS01896 HS02087 HS02278 HS02403 HS02574 HS00073 HS00435 HS00646 HS00879 HS01108 HS013ll HSOISIO HS01704 HS01897 HS02088 HS02279 HS02406 HS02575 HS00074 HS00440 HS00649 HS00881 HS01109 HS01313 HSOISll HS01707 HS01900 HS02090 HS02280 HS02408 HS02576 HS00075 HS00443 HS00654 HS00890 HSOI113 HS01314 HSOISIS HS01708 HS01902 HS02097 HS02282 HS02409 HS02584 HS00077 HS00452 HS00664 HS00892 HSOlll9 HS01320 HSOIS25 HS01709 HS01908 HS02099 HS02283 HS024ll HS02586 HS00078 HS004SS h500666 HS00897 HSOII20 HS01324 HSOIS30 HS0171",".","2508 units","Varian has identified an anomaly with the RPM Respiratory Gating System version I.7.5 with 3D Option. While operating with the 6-dot marker block, this version of RPM Gating may produce an inverted respiratory waveform in amplitude and phase-gating sessions.",3/26/2013,"03/26/2013",5/1/2013,"05/01/2013"
"Biologics",64829,"Terminated","LifeShare Community Blood Services","Elyria","OH","US","Voluntary: Firm Initiated","Letter","Ohio","B-1608-13","Class II","Red Blood Cells (Apheresis) Leukocytes Reduced","W043811520629 Part 1; W043811520629 Part 2; W043811521219 Part 1; W043811521219 Part 2; W043811521338 Part 1; W043811521338 Part 2; ",,"6","Blood products, which were collected from a donor who had traveled to an area considered endemic for malaria, were distributed. ",3/19/2013,"03/19/2013",6/26/2013,"06/26/2013"
"Devices",64830,"Ongoing","Synthes USA HQ, Inc.","West Chester","PA","US","Voluntary: Firm Initiated","Letter","Nationwide distribution.","Z-1557-2013","Class II","Synthes 11-Hole, 1/3 Tubular Plate DCL Plate with Collar, Part Number 241.000.011","Part Number 241.000.011, lot number S2004",,"10","The Synthes One-Third Tubular DCL Plate (11-Hole, 1/3 Tubular Plate w/Collar), was released to the United States market in error. This action is not being initiated as a result of adverse events.",2/22/2013,"02/22/2013",6/26/2013,"06/26/2013"
"Food",64831,"Ongoing","Chemi- Source Inc, Nutra Pak","Grand Rapids","MI","US","Voluntary: Firm Initiated","Telephone","nationwide","F-1501-2013","Class II","Sprouts Farmers Market Whey Protein Chocolate: 1 lbs, 2 lbs : Whey Protein/Isolate, Soy Lecithin UPC 6-46670 68120-2 (1 lbs) UPC 6-46670 68126-4 (2 lbs) ","expiration date between Jan 2013 and March 2016. ",".","1 # x 5,872; 2# x 7,798","Source of whey ingredient not listed as milk, an allergen. Consumers who have an allergy or severe sensitivity to milk run the risk of a serious or life-threatening allergic reaction if they consume these products. ",4/2/2013,"04/02/2013",6/12/2013,"06/12/2013"
"Food",64831,"Ongoing","Chemi- Source Inc, Nutra Pak","Grand Rapids","MI","US","Voluntary: Firm Initiated","Telephone","nationwide","F-1495-2013","Class II","Metabolic Whey - Vanilla5 LBS French Vanilla 10lbs: Whey Protein/Isolate, Soy Lecithin UPC 6-09492 72051-1 (VANILLA) UPC 6-09492 72054-2 (FRENCH VANILLA) ","expiration date between Jan 2013 and March 2016. ",".","5 # x 34,409 ; 10 # x 12,925","Source of whey ingredient not listed as milk, an allergen; soy lecithin stated as ''lecithin''.Consumers who have an allergy or severe sensitivity to milk or soy run the risk of a serious or life-threatening allergic reaction if they consume these products. ",4/2/2013,"04/02/2013",6/12/2013,"06/12/2013"
"Food",64831,"Ongoing","Chemi- Source Inc, Nutra Pak","Grand Rapids","MI","US","Voluntary: Firm Initiated","Telephone","nationwide","F-1497-2013","Class II","Flax-N-Whey and Flax-N-Whey Vanilla Nut 1.99 lbs: Whey Protein/Isolate Contains: Soy, Dairy, Flaxseed UPC 6-09492 72064-1 "," expiration date between Jan 2013 and March 2016. ",".","4072","Source of whey ingredient not listed as milk, an allergen. Consumers who have an allergy or severe sensitivity to milk run the risk of a serious or life-threatening allergic reaction if they consume these products. ",4/2/2013,"04/02/2013",6/12/2013,"06/12/2013"
"Food",64831,"Ongoing","Chemi- Source Inc, Nutra Pak","Grand Rapids","MI","US","Voluntary: Firm Initiated","Telephone","nationwide","F-1496-2013","Class II","Fruit-N-Whey 2.03lbs and Fruit-N-Whey Mixed Berries 2.03 lbs: Whey Protein/Isolate, Soy Lecithin. Contains: Dairy, Benefruit Blend, Natural Berry Flavors UPC 6-09492 72065-8 "," expiration date between Jan 2013 and March 2016. ",".","5047","Source of whey ingredient not listed as milk, an allergen. Consumers who have an allergy or severe sensitivity to milk run the risk of a serious or life-threatening allergic reaction if they consume these products. ",4/2/2013,"04/02/2013",6/12/2013,"06/12/2013"
"Food",64831,"Ongoing","Chemi- Source Inc, Nutra Pak","Grand Rapids","MI","US","Voluntary: Firm Initiated","Telephone","nationwide","F-1482-2013","Class II","Metabolic Whey - Straw/Banana5 LBS & 10 LBS: Whey Protein Concentrate/ Isolate, UPC 6-09492 72052-8, 72055-9","expiration date between Jan 2013 and March 2016. ",".","5# x 12,925; 10 # x 2,054","Source of whey ingredient not listed as milk and source of lecithin not listed as soy. Milk and soy are allergens. Consumers who have an allergy or severe sensitivity to milk, soy run the risk of a serious or life-threatening allergic reaction if they consume these products. ",4/2/2013,"04/02/2013",6/12/2013,"06/12/2013"
"Food",64831,"Ongoing","Chemi- Source Inc, Nutra Pak","Grand Rapids","MI","US","Voluntary: Firm Initiated","Telephone","nationwide","F-1492-2013","Class II","Low Carb Protein - Creamy Chocolate1.78 LBS: Whey Protein/Isolate, Soy Lecithin, Casein/Caseinate, Cocoa UPC 6-09492 72017-7 "," expiration date between Jan 2013 and March 2016. ",".","22,712","Source of whey and casein ingredient not listed as milk, an allergen.Consumers who have an allergy or severe sensitivity to milk run the risk of a serious or life-threatening allergic reaction if they consume these products. ",4/2/2013,"04/02/2013",6/12/2013,"06/12/2013"
"Food",64831,"Ongoing","Chemi- Source Inc, Nutra Pak","Grand Rapids","MI","US","Voluntary: Firm Initiated","Telephone","nationwide","F-1499-2013","Class II","All Natural Whey - Rich Vanilla: 2.02 lbs, 1.01 lbs and 10pk/bx : Whey Protein/Isolate Contains: Soy, Dairy, Nitrozyme UPC 6-09492 72002-3 (2.02 lbs) UPC 6-09492 72006-1 (1.01 lbs) UPC 6-09492 72094-8 (10 pk) ","expiration date between Jan 2013 and March 2016. ",".","2.02# x 187,888; 1.01#x 80,085; 10 pk x 13, 578","Source of whey ingredient not listed as milk, an allergen. Consumers who have an allergy or severe sensitivity to milk run the risk of a serious or life-threatening allergic reaction if they consume these products. ",4/2/2013,"04/02/2013",6/12/2013,"06/12/2013"
"Food",64831,"Ongoing","Chemi- Source Inc, Nutra Pak","Grand Rapids","MI","US","Voluntary: Firm Initiated","Telephone","nationwide","F-1502-2013","Class II","Sprouts Farmers Market Whey Protein Strawberry: 1 lbs, 2 lbs : Whey Protein/Isolate, Soy Lecithin UPC 6-46670 68122-6 (1 lbs) UPC 6-46670 68128-8 (2 lbs): ","expiration date between Jan 2013 and March 2016. ",".","1 lb x 4,946; 2 lb x 4715","Source of whey ingredient not listed as milk, an allergen. Consumers who have an allergy or severe sensitivity to milk run the risk of a serious or life-threatening allergic reaction if they consume these products. ",4/2/2013,"04/02/2013",6/12/2013,"06/12/2013"
"Food",64831,"Ongoing","Chemi- Source Inc, Nutra Pak","Grand Rapids","MI","US","Voluntary: Firm Initiated","Telephone","nationwide","F-1489-2013","Class II","Massive Muscle Gainer- Weight Gainer French Vanilla10 LBS: Whey Protein/Isolate, Soy Lecithin, Casein/Caseinate UPC 6-09492 73003-9 "," expiration date between Jan 2013 and March 2016. ",".","3,227","Source of whey and casein ingredient not listed as milk, an allergen.Consumers who have an allergy or severe sensitivity to milk run the risk of a serious or life-threatening allergic reaction if they consume these products. ",4/2/2013,"04/02/2013",6/12/2013,"06/12/2013"
"Food",64831,"Ongoing","Chemi- Source Inc, Nutra Pak","Grand Rapids","MI","US","Voluntary: Firm Initiated","Telephone","nationwide","F-1479-2013","Class II","Isolate Whey Protein Chocolate Malt 2.03 LBS: Whey Protein Concentrate/ Isolate, Casein/Caseinate, Contains: Soy, Dairy, Cocoa, Xylitol ; UPC 6-09492 73010-7"," expiration date between Jan 2013 and March 2016. ",".","10,860","Source of whey ingredient not listed as milk, an allergen. Consumers who have an allergy or severe sensitivity to milk run the risk of a serious or life-threatening allergic reaction if they consume these products. ",4/2/2013,"04/02/2013",6/12/2013,"06/12/2013"
"Food",64831,"Ongoing","Chemi- Source Inc, Nutra Pak","Grand Rapids","MI","US","Voluntary: Firm Initiated","Telephone","nationwide","F-1483-2013","Class II","UPC6-09492 72050-4, 72053-5 , Metabolic Whey - Rich Chocolate5 LBS, 10 LBS : Whey Protein Concentrate/ Isolate, Cocoa"," expiration date between Jan 2013 and March 2016. ",".","5 # x 34,409; 10# x 7,983","Source of whey ingredient not listed as milk and source of lecithin ingredient not listed as soy, Milk and soy are allergens. Consumers who have an allergy or severe sensitivity to milk, soy run the risk of a serious or life-threatening allergic reaction if they consume these products. ",4/2/2013,"04/02/2013",6/12/2013,"06/12/2013"
"Food",64831,"Ongoing","Chemi- Source Inc, Nutra Pak","Grand Rapids","MI","US","Voluntary: Firm Initiated","Telephone","nationwide","F-1498-2013","Class II","MRM All Natural Whey - Dutch Chocolate 2.02 lbs, 1.01 lbs; All Natural Whey 10pk/bx Dutch Chocolate: Whey Protein/Isolate Contains: Soy, Dairy, Cocoa, Nitrozyme UPC 6-09492 72004-7 (2.02 lbs) UPC 6-09492 72095-5 (10 pk) UPC 6-09492 72005-4(1.01 lbs) "," expiration date between Jan 2013 and March 2016. ; ",".","2.02 # x 136726; 1.01 # x 49,235; 10 pak x 42,699","Source of whey ingredient not listed as milk, an allergen. Consumers who have an allergy or severe sensitivity to milk run the risk of a serious or life-threatening allergic reaction if they consume these products. ",4/2/2013,"04/02/2013",6/12/2013,"06/12/2013"
"Food",64831,"Ongoing","Chemi- Source Inc, Nutra Pak","Grand Rapids","MI","US","Voluntary: Firm Initiated","Telephone","nationwide","F-1494-2013","Class II","Massive Muscle Gainer- Weight Gainer Dutch Chocolate10 LBS: Whey Protein/Isolate, Soy Lecithin, Casein/Caseinate, Cocoa UPC 6-09492 73002-2"," expiration date between Jan 2013 and March 2016. ",".","14,813","Source of whey and casein ingredient not listed as milk, an allergen.Consumers who have an allergy or severe sensitivity to milk run the risk of a serious or life-threatening allergic reaction if they consume these products. ",4/2/2013,"04/02/2013",6/12/2013,"06/12/2013"
"Food",64831,"Ongoing","Chemi- Source Inc, Nutra Pak","Grand Rapids","MI","US","Voluntary: Firm Initiated","Telephone","nationwide","F-1487-2013","Class II","Casein - 100% Micellar Casein - Cookies & Cream2.02 LBS: Soy Lecithin,Casein/Caseinate,Wheat UPC 6-09492 72242-3","expiration date between Jan 2013 and March 2016. ",".","1,320","Source of casein ingredient not listed as milk, an allergen.Consumers who have an allergy or severe sensitivity to milk run the risk of a serious or life-threatening allergic reaction if they consume these products. ",4/2/2013,"04/02/2013",6/12/2013,"06/12/2013"
"Food",64831,"Ongoing","Chemi- Source Inc, Nutra Pak","Grand Rapids","MI","US","Voluntary: Firm Initiated","Telephone","nationwide","F-1503-2013","Class II","Delicious Whole-istic Whey Protein Duch Chocolate 1.6 lbs: Whey Protein/Isolate, Contains: Dairy, Soy Lecithin UPC8-54809 0030-9"," expiration date between Jan 2013 and March 2016. ",".","0 , corrected in warehouse","Source of whey ingredient not listed as milk, an allergen. Consumers who have an allergy or severe sensitivity to milk run the risk of a serious or life-threatening allergic reaction if they consume these products. ",4/2/2013,"04/02/2013",6/12/2013,"06/12/2013"
"Food",64831,"Ongoing","Chemi- Source Inc, Nutra Pak","Grand Rapids","MI","US","Voluntary: Firm Initiated","Telephone","nationwide","F-1484-2013","Class II","It Works Ultimate Profit Chocolate1.6 LBS: Whey Protein Concentrate/ Isolate, Soy Protein Extract, Soy Hull Fiber; Soy Protein Isolate; Contains: Dairy, Cocoa",": Product distributed with expiration date between Jan 2013 and March 2016. ",".","74409","Source of whey ingredient not listed as milk, an allergen.Consumers who have an allergy or severe sensitivity to milk run the risk of a serious or life-threatening allergic reaction if they consume these products. ",4/2/2013,"04/02/2013",6/12/2013,"06/12/2013"
"Food",64831,"Ongoing","Chemi- Source Inc, Nutra Pak","Grand Rapids","MI","US","Voluntary: Firm Initiated","Telephone","nationwide","F-1485-2013","Class II","It Works Ultimate Profit Vanilla1.55 LBS: Whey Protein Concentrate/ Isolate, Soy Protein, Soy Hull Flower Contains: Dairy","Product distributed with expiration date between Jan 2013 and March 2016. ",".","69519","Source of whey ingredient not listed as milk, an allergen.Consumers who have an allergy or severe sensitivity to milk run the risk of a serious or life-threatening allergic reaction if they consume these products. ",4/2/2013,"04/02/2013",6/12/2013,"06/12/2013"
"Food",64831,"Ongoing","Chemi- Source Inc, Nutra Pak","Grand Rapids","MI","US","Voluntary: Firm Initiated","Telephone","nationwide","F-1500-2013","Class II","Sprouts Farmers Market Whey Protein Vanilla: 1 lbs, 2 lbs : Whey Protein/Isolate, Soy Lecithin UPC 6-46670 68118-9 (1 lbs) UPC 6-46670 68124-0 (2 lbs) "," expiration date between Jan 2013 and March 2016. ",".","1 # x 16,010; 2 # x 12,727","Source of whey ingredient not listed as milk, an allergen. Consumers who have an allergy or severe sensitivity to milk run the risk of a serious or life-threatening allergic reaction if they consume these products. ",4/2/2013,"04/02/2013",6/12/2013,"06/12/2013"
"Food",64831,"Ongoing","Chemi- Source Inc, Nutra Pak","Grand Rapids","MI","US","Voluntary: Firm Initiated","Telephone","nationwide","F-1491-2013","Class II","All Natural Gainer- Rich Vanilla3.3 LBS: Whey Protein/Isolate, Soy Lecithin, Casein/Caseinate UPC 6-09492 73003-9","expiration date between Jan 2013 and March 2016. ",".","19,338","Source of whey and casein ingredient not listed as milk, an allergen.Consumers who have an allergy or severe sensitivity to milk run the risk of a serious or life-threatening allergic reaction if they consume these products. ",4/2/2013,"04/02/2013",6/12/2013,"06/12/2013"
"Food",64831,"Ongoing","Chemi- Source Inc, Nutra Pak","Grand Rapids","MI","US","Voluntary: Firm Initiated","Telephone","nationwide","F-1481-2013","Class II","Low Carb Protein -Strawberry/Banana1.78 LBS: Whey Protein Concentrate/ Isolate, Casein/Caseinate,Soy Lecithin, Red Beet Powder UPC 6-09492 72018-4"," expiration date between Jan 2013 and March 2016. ",".","7,441","Source of whey ingredient not listed as milk, an allergen. Consumers who have an allergy or severe sensitivity to milk run the risk of a serious or life-threatening allergic reaction if they consume these products. ",4/2/2013,"04/02/2013",6/12/2013,"06/12/2013"
"Food",64831,"Ongoing","Chemi- Source Inc, Nutra Pak","Grand Rapids","MI","US","Voluntary: Firm Initiated","Telephone","nationwide","F-1480-2013","Class II","Isolate Whey Protein French Vanilla 1.99 LBS: Whey Protein Concentrate/ Isolate, Casein/Caseinate, Contains: Soy, Dairy, Xylitol UPC 6-09492 73011-4","expiration date between Jan 2013 and March 2016. ",".","12,431","Source of whey ingredient not listed as milk, an allergen. Consumers who have an allergy or severe sensitivity to milk run the risk of a serious or life-threatening allergic reaction if they consume these products. ",4/2/2013,"04/02/2013",6/12/2013,"06/12/2013"
"Food",64831,"Ongoing","Chemi- Source Inc, Nutra Pak","Grand Rapids","MI","US","Voluntary: Firm Initiated","Telephone","nationwide","F-1493-2013","Class II","All Natural Gainer - Chocolate3.3 LBS: Whey Protein/Isolate, Soy Lecithin, Casein/Caseinate, Cocoa UPC 6-09492 73004-6","expiration date between Jan 2013 and March 2016. ",".","16,318","Source of whey and casein ingredient not listed as milk, an allergen.Consumers who have an allergy or severe sensitivity to milk run the risk of a serious or life-threatening allergic reaction if they consume these products. ",4/2/2013,"04/02/2013",6/12/2013,"06/12/2013"
"Food",64831,"Ongoing","Chemi- Source Inc, Nutra Pak","Grand Rapids","MI","US","Voluntary: Firm Initiated","Telephone","nationwide","F-1490-2013","Class II","Low Carb Protein- French Vanilla1.78 LBS: Whey Protein/Isolate, Soy Lecithin, Casein/Caseinate UPC 6-09492 72016-0","expiration date between Jan 2013 and March 2016. ",".","UPC 6-09492 72016-0","Source of whey and casein ingredient not listed as milk, an allergen.Consumers who have an allergy or severe sensitivity to milk run the risk of a serious or life-threatening allergic reaction if they consume these products. ",4/2/2013,"04/02/2013",6/12/2013,"06/12/2013"
"Food",64831,"Ongoing","Chemi- Source Inc, Nutra Pak","Grand Rapids","MI","US","Voluntary: Firm Initiated","Telephone","nationwide","F-1478-2013","Class II","All Natural Whey - Natural Flavor 1.89 LBS: Whey Protein Concentrate and Isolate, Casein/Caseinate, Nitrozyme UPC 6-09492 72000-9 :","expiration date between Jan 2013 and March 2016. ","."," 24924","Source of whey ingredient not listed as milk, an allergen. Consumers who have an allergy or severe sensitivity to milk run the risk of a serious or life-threatening allergic reaction if they consume these products. ",4/2/2013,"04/02/2013",6/12/2013,"06/12/2013"
"Food",64831,"Ongoing","Chemi- Source Inc, Nutra Pak","Grand Rapids","MI","US","Voluntary: Firm Initiated","Telephone","nationwide","F-1486-2013","Class II","Casein - 100% Micellar Casein - Rich Chocolate2.02 LBS: Soy Lecithin,Casein/Caseinate, Cocoa UPC 6-09492 72240-9 ","expiration date between Jan 2013 and March 2016. ",".","2932","Source of casein ingredient not listed as milk, an allergen.Consumers who have an allergy or severe sensitivity to milk run the risk of a serious or life-threatening allergic reaction if they consume these products. ",4/2/2013,"04/02/2013",6/12/2013,"06/12/2013"
"Food",64831,"Ongoing","Chemi- Source Inc, Nutra Pak","Grand Rapids","MI","US","Voluntary: Firm Initiated","Telephone","nationwide","F-1488-2013","Class II","Casein - 100% Micellar Casein - Vanilla Ice Cream2.04 LBS: Soy Lecithin,Casein/Caseinate UPC 6-09492 72241-6 "," expiration date between Jan 2013 and March 2016. ",".","1,182","Source of casein ingredient not listed as milk, an allergen.Consumers who have an allergy or severe sensitivity to milk run the risk of a serious or life-threatening allergic reaction if they consume these products. ",4/2/2013,"04/02/2013",6/12/2013,"06/12/2013"
"Devices",64832,"Ongoing","Hospira Inc.","Lake Forest","IL","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution - USA including AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV, WY. Internationally to Australia, New Zealand, China, Hong Kong, Taiwan, Japan, Korea, Philippines, Thailand, Malaysia, Canada, Austria, Bahrain, Belgium, Croatia, Denmark, Egypt, Finland, France, Germany, Gibraltar, Greece, Hungary, Iceland, Ireland, Israel, Italy, Jordan, Kuwait, Lebanon, Libya, Luxembourg, Malta, Netherlands, Norway, Oman, Portugal, Qatar, Romania, Saudi Arabia, Slovenia, South Africa, Spain, Sweden, Switzerland, Turkey, UK, United Arab Emirates, Brazil, Chile and Colombia.","Z-0350-2014","Class I","The GemStar Pump is a small and lightweight, single channel infusion device designed for use in the home, in the hospital, or anywhere electronic infusion is required. The GemStar Pump can be powered by AC mains adaptor, rechargeable battery pack, docking station, or two disposable AA alkaline batteries. When powered by batteries, The GemStar Pump is ideal for ambulatory patients. ","*** 1) List Number: 13086, Serial Numbers: 15651117 , 15651119 , 15651121, 15651122 , 15651124 , 15651125 , 15651128 , 15651129 , 15651131 , 15651134 , 15651138 , 15651140 , 15651123 , 15651132 , 15651133 , 15651136 , 15651137 , 15651139 , 15651116 , 15651118 , 15651120 , 15651126 , 15651127 , 15651130 , 15651135 , 15651141 , 15651142 , 15651143 , 15651144 , 15651147 , 15651148 , 15651151 , 15651152 , 15651153 , 15651154 , 15651156 , 15651157 , 15651158 , 15651159 , 15651160 , 15651161 , 15651162 , 15651163 , 15651164 , 15651165 , 15651145 , 15651155 , 15651149 , 18877402 , 18877406 , 18877407 , 18877412 , 18877415 , 18877417 , 18877424 , 18877429 , 18877430 , 18877436 , 18877440 , 18877443 , 18877401 , 18877403 , 18877404 , 18877405 , 18877408 , 18877409 , 18877410 , 18877411 , 18877413 , 18877414 , 18877416 , 18877418 , 18877419 , 18877420 , 18877421 , 18877422 , 18877423 , 18877425 , 18877426 , 18877427 , 18877428 , 18877431 , 18877432 , 18877433 , 18877434 , 18877435 , 18877437 , 18877438 , 18877439 , 18877441 , 18877442 , 18877444 , 18877445 , 18877446 , 18877447 , 18877449 , 18877450 , 18877451 , 18877452 , 18877453 , 18877454 , 18877455 , 18877456 , 18877457 , 18877458 , 18877459 , 18877460 , 18877467 , 18877475 , 18877481 , 18877485 , 18877486 , 18877488 , 18877461 , 18877464 , 18877465 , 18877466 , 18877468 , 18877469 , 18877471 , 18877473 , 18877480 , 18877482 , 18877483 , 18877484 , 18877487 , 18877489 , 18877491 , 18877492 , 18877493 , 18877494 , 18877496 , 18877497 , 18877498 , 18877499 , 18877501 , 18877502 , 18877503 , 18877504 , 18877506 , 18877507 , 18877508 , 18877509 , 18877510 , 18877490 , 18877505 , 18877511 , 18877513 , 18877515 , 18877517 , 18877521 , 18877522 , 18877524 , 18877525 , 18877526 , 18877527 , 18877528 , 18877529 , 18877530 , 18877531 , 18877532 , 18877533 , 18877534 , 18877535 , 18877536 , 18877538 , 18877539 , 18877540 , 18877541 , 18877544 , 18877545 , 18877555 , 15651117 ; *** 2) List Number: 13087, Serial Numbers: 15661077 , 15661236 , 15661349 , 15661325 , 15661347 , 15"," 75544323 , 75544324 , 75544264 , 75544292 , 75544293 , 75544297 , 75544306 , 75544313 , 75544325 , 75544328 , 75544330 , 75544331 , 75544332 , 75544333 , 75544334 , 75544337 , 75544338 , 75544341 , 75544342 , 75544344 , 75544355 , 75544273 , 75544303 , 75544326 , 75544327 , 75544329 , 75544340 , 75544343 , 75544345 , 75544346 , 75544347 , 75544348 , 75544349 , 75544350 , 75544352 , 75544353 , 75544354 , 75544308 , 75544336 , 75544339 , 75544357 , 75544358 , 75544359 , 75544360 , 75544361 , 75544362 , 75544363 , 75544364 , 75544365 , 75544366 , 75544367 , 75544368 , 75544369 , 75544381 , 75544384 , 75544386 , 15671754 , 15671758 , 15671967 , 15671971 , 75544335 , 75544351 , 75544356 , 75544370 , 75544371 , 75544373 , 75544374 , 75544375 , 75544376 , 75544377 , 75544380 , 75544382 , 75544383 , 75544385 , 75544387 , 75544389 , 75544390 , 75544391 , 75544393 , 75544394 , 75544395 , 75544397 , 75544398 , 75544399 , 75544402 , 75544403 , 75544404 , 75544408 , 75544409 , 75544410 , 15671770 , 15671771 , 15671772 , 15671773 , 15671774 , 15671775 , 15671776 , 15671777 , 15671778 , 15671779 , 15671780 , 15671781 , 15671783 , 15671784 , 15671785 , 15671786 , 15671788 , 15671790 , 15671792 , 15671793 , 15671795 , 15671796 , 15671797 , 15671798 , 15671964 , 75544295 , 75544372 , 75544378 , 75544379 , 75544388 , 75544396 , 75544400 , 75544401 , 75544405 , 75544406 , 75544407 , 75544411 , 75544412 , 15671782 , 15671789 , 15671791 , 15671799 , 15671801 , 15671802 , 15671803 , 15671804 , 15671806 , 15671810 , 15671811 , 15671812 , 15671815 , 15671816 , 15671817 , 15671818 , 75053009 , 75053010 , 75053016 , 75053019 , 75544392 , 75544413 , 15671716 , 15671718 , 15671732 , 15671759 , 15671763 , 15671794 , 15671808 , 15671813 , 15671821 , 15671857 , 75053006 , 75053007 , 75053008 , 75053013 , 75053014 , 75053015 , 75053017 , 75053018 , 75053020 , 75053021 , 75053022 , 75053023 , 75053024 , 75053025 , 75053027 , 75053028 , 75053029 , 75053030 , 75053031 , 75053046 , 75053047 , 75053048 , 75053049 , 75053050 , 75053051 , 75053052 ","43,840","The proximal and distal pressure sensor calibration can drift resulting in the pump failing the Proximal or Distal Occlusion Operational Test, as described in the GemStar Technical Service Manual, or reporting one of the following errors during device setup or infusion: 1) Cassette Check - D; 2) Cassette Check - P; 3) Proximal Occlusion; 4) Distal Occlusion; 5) Pressure Calibration Error; 6) Bad Pressure Sensor Event; 7) Bad Pressure State; 8) Distal Pressure is Out of Range; 9) Proximal Sensor is Out of Range. A pump with this issue may, instead of reporting an error, not detected occlusions or issue false occlusion alarms, which will stop the infusion and invoke visual and audible warnings to the user.",3/15/2013,"03/15/2013",11/27/2013,"11/27/2013"
"Devices",64832,"Ongoing","Hospira Inc.","Lake Forest","IL","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution - USA including AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV, WY. Internationally to Australia, New Zealand, China, Hong Kong, Taiwan, Japan, Korea, Philippines, Thailand, Malaysia, Canada, Austria, Bahrain, Belgium, Croatia, Denmark, Egypt, Finland, France, Germany, Gibraltar, Greece, Hungary, Iceland, Ireland, Israel, Italy, Jordan, Kuwait, Lebanon, Libya, Luxembourg, Malta, Netherlands, Norway, Oman, Portugal, Qatar, Romania, Saudi Arabia, Slovenia, South Africa, Spain, Sweden, Switzerland, Turkey, UK, United Arab Emirates, Brazil, Chile and Colombia.","Z-0349-2014","Class I","The GemStar Pump is a small and lightweight, single channel infusion device designed for use in the home, in the hospital, or anywhere electronic infusion is required. The GemStar Pump can be powered by AC mains adaptor, rechargeable battery pack, docking station, or two disposable AA alkaline batteries. When powered by batteries, The GemStar Pump is ideal for ambulatory patients. ","*** 1) List Number 13000, Serial Numbers: 98121336 , 98121173 , 98120835 , 98120730 , 98120768 , 98120782 , 98120788 , 98120822 , 98120824 , 98120839 , 98120856 , 98120880 , 98120885 , 98120895 , 98120915 , 98120749 , 98120769 , 98120774 , 98120784 , 98120859 , 98120884 , 98121019 , 98121066 , 98121079 , 98121083 , 98121135 , 98121153 , 98121163 , 98121197 , 98120522 , 98120653 , 13431222 , 98120635 , 98120405 , 98120508 , 98120634 , 98121147 , 98120543 , 12470380 , 98120512 , 98120815 , 98120681 , 97971490 , 97970893 , 97970240 , 98070264 , 98070295 , 99170068 , 99170032 , 98070345 , 98070476 , 98070905 , 98070995 , 97972107 , 97972609 , 97971538 , 98021653 , 98021821 , 99400401 , 99400435 , 97970456 , 13431303 , 98021816 , 97972825 , 98021121 , 97971767 , 99107521 , 98020395 , 14180727 , 98120459 , 98120495 , 98120777 , 98020964 , 98070286 , 98121157 , 97972571 , 97970541 , 97971254 , 98120535 , 98120640 , 98120840 , 97970194 , 98021636 , 98020575 , 97972639 , 99222573 , 98021550 , 98021603 , 98021682 , 98370030 , 98020523 , 98020446 , 98020441 , 99107526 , 97971754 , 98020929 , 98020932 , 98022223 , 13434785 , 98020072 , 98020317 , 98021476 , 98021478 , 98021732 , 98021891 , 98021912 , 98021252 , 99170080 , 98020623 , 98020018 , 98020293 , 98020574 , 98021031 , 98021423 , 98021449 , 98020013 , 97972018 , 98021177 , 98020264 , 99221974 , 98020817 , 98021687 , 98070125 , 98021304 , 98021546 , 98022039 , 98020281 , 97972802 , 97972086 , 97971122 , 12470492 , 98121130 , 97972659 , 97972489 , 98120869 , 13433080 , 97972047 , 97972824 , 98020549 , 98021584 , 97970313 , 97970073 , 98021364 , 98020312 , 98021961 , 98020127 , 98020606 , 98021194 , 99222658 , 98020490 , 98021141 , 98021276 , 98021171 , 98020460 , 98021969 , 99107535 , 99221815 , 98021977 , 98021120 , 98021412 , 99222620 , 14180122 , 99400456 , 98071220 , 98070607 , 98070371 , 98070781 , 98070815 , 98070696 , 98070812 , 97972981 , 97970766 , 98020074 , 98020902 , 14180174 , 99219028 , 98070190 , 13433667 , 97970613 , 98021101 , 98021099 , 97970666 , 9"," 13631846 , 13636102 , 98432261 , 13631447 , 13631990 , 13632025 , 13631865 , 13631879 , 13630504 , 13630530 , 12720603 , 12720078 , 13630394 , 13632708 , 13630923 , 12721040 , 13632034 , 13634552 , 13633626 , 13630336 , 13633601 , 13631609 , 13632051 , 13631472 , 13635381 , 13636809 , 13633594 , 13634073 , 12721141 , 12720171 , 13634261 , 13630069 , 13636466 , 13630687 , 13633552 , 13635752 , 13632076 , 13633677 , 13634154 , 13631956 , 13630256 , 13631832 , 12720602 , 13635544 , 13631302 , 13630617 , 13635445 , 99270871 , 13630913 , 13631682 , 12720169 , 13633951 , 13630784 , 13635442 , 98432167 , 13631481 , 13630623 , 13636329 , 12720512 , 13630104 , 13631282 , 12721197 , 13631352 , 13630467 , 12721084 , 13631740 , 13630141 , 13631015 , 12720433 , 13632089 , 13631820 , 13632125 , 13630027 , 13631713 , 13631573 , 13630719 , 13634370 , 13632588 , 13635534 , 98432097 , 98431056 , 13631502 , 12720322 , 13631626 , 13631586 , 13632346 , 13633570 , 13635869 , 98431297 , 13631417 , 13632221 , 13632191 , 13631743 , 99271127 , 13636802 , 13632240 , 99271084 , 99271080 , 99271091 , 13633633 , 13631519 , 12720983 , 13631462 , 12721222 , 13637206 , 13631584 , 13631599 , 13637326 , 13635800 , 12720737 , 13632138 , 12721081 , 13630248 , 13634917 , 98431260 , 13635706 , 13635632 , 13635758 , 13635625 , 98431180 , 13636299 , 13630372 , 13631426 , 13631046 , 13630525 , 13632172 , 12721203 , 13630352 , 13630783 , 98430673 , 98432184 , 99270486 , 13637032 , 13633958 , 13631541 , 13630954 , 13630861 , 13630910 , 13635285 , 12720140 , 12720095 , 13630125 , 13631824 , 13635764 , 13637272 , 13630710 , 13631041 , 13635374 , 13631232 , 12720238 , 13635849 , 13635497 , 13631001 , 13634214 , 13635298 , 98430636 , 98432199 , 13636202 , 13630951 , 13633647 , 13636059 , 13631164 , 13631316 , 13634405 , 13635449 , 13630662 , 12720282 , 98432098 , 12720191 , 13632081 , 13632241 , 13632033 , 13631697 , 13630207 , 13631577 , 12720729 , 13630933 , 13631413 , 13631695 , 13633951 , 13631636 , 13631639 , 13631200 , 99270518 , 13636502 , 12721143 ","1) List Number 13000: 2,162 pumps; 2) List Number 13100: 15 pumps; 3) List Number 13150: 1,955 pumps","The proximal and distal pressure sensor calibration can drift resulting in the pump failing the Proximal or Distal Occlusion Operational Test, as described in the GemStar Technical Service Manual, or reporting one of the following errors during device setup or infusion: 1) Cassette Check - D; 2) Cassette Check - P; 3) Proximal Occlusion; 4) Distal Occlusion; 5) Pressure Calibration Error; 6) Bad Pressure Sensor Event; 7) Bad Pressure State; 8) Distal Pressure is Out of Range; 9) Proximal Sensor is Out of Range. A pump with this issue may, instead of reporting an error, not detected occlusions or issue false occlusion alarms, which will stop the infusion and invoke visual and audible warnings to the user.",3/15/2013,"03/15/2013",11/27/2013,"11/27/2013"
"Devices",64833,"Ongoing","Vital Images, Inc.","Minnetonka","MN","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution -- USA, excluding RI and SD and including DC and PR, and the countries of ALGERIA, ANGOLA, ARGENTINA, AUSTRALIA, AUSTRIA, BELGIUM, BELARUS, BOLIVIA, BRAZIL, BULGARIA, CAMBODIA, CANADA, CHILE, CHINA, COLOMBIA, CYPRUS, CZECH REPUBLIC, DENMARK, EGYPT, FINLAND, FRANCE, GEORGIA, GERMANY, CHANA, GREECE, GUAM, HONDURAS, HONG KONG, ICELAND, INDIA, INDONESIA, IRAQ, IRELAND, ISRAEL, ITALY, JAPAN,JORDAN, KOREA, KUWAIT, LEBANON, LITHUANIA, MALAYSIA, MEXICO, MOSCOW, MYANMAR, NAMIBIA, NETHERLANDS, NEW ZEALAND, NIGERIA, NORTHERN IRELAND, NORWAY, OMAN, PAKISTAN, PANAMA, PERU, PHILIPPINES, POLAND, PORTUGAL, QATAR, ROMANIA, RUSSIA, SAUDI ARABIA, SERBIA, SERBIA AND MONTENEGRO, SINGAPORE, SLOVAKIA, SLOVENIA, SOUTH AFRICA, SPAIN, SRI LANKA, SWEDEN, SWITZERLAND, TAIWAN, THAILAND, TUNISIA, TURKEY, UKRAINE, UNITED ARAB EMIRATES, UNITED KINGDOM, UZBEKISTAN, VENEZUELA, VIETNAM, and YEMEN.","Z-1181-2013","Class II","Vitrea CT Brain Perfusion made available in various configurations under the names Vitrea, Vitrea fX, VitreaAdvanced and Vitrea Enterprise Suite. Noninvasive post-processing application designed to evaluate areas of brain perfusion.","Versions 6.0 and above. Serial Numbers: VPE0503066 VPE0911551 VPE0908462 324112 VPE0503082 VPE0707078 VPE0707079 5040227558 5040227590 VPE0503081 VPE0609168 5040227140 VPE0707067 VPE1006732 VPE1011765 VPE0707087 5080113685 VPE0802171 VPE0805209 VPE0805281 VPE0902329 475604 5080121211 357678 5080119381 395647 5090112096 449462 VPE1003630 5090102007 VPE0502007 VPE0602118 VPE0602122 VPE0602117 N/A N/A VPE0503073 475635 5090111480 5090111472 5040227329 5031211482 5040919344 VPE0602131 5080117869 5090111960 373409 5090103704 VESADLCC1206033 5090102775 N/A VPE0503080 5080121653 VPE1211025 5080117230 5030861645 5090104980 470268 5090102848 5080116463 VPE0503068 VPE0707080 VPE0707074 5040227507 5080116269 VPE0503048 5090114366 VPE0710133 5080116382 5080115025 5090110263 VPE0503079 VPE1006755 VPE0503052 5040919425 5090103755 VPE0502024 5040919263 5080119233 VPE0503046 VPE0503059 UPGD1011004 VPE0502001 5080113057 N/A VPE1202981 5090112835 VPE0702039 5090102252 VESADLCC1209037 5090109508 5090114188 5080108460 5080117117 VPE0503047 5080117486 VPE0710128 VPE0710129 VPE0502002 VPE0710130 VPE0502010 VPE0602145 5090104069 5080115149 5080119934 5080118016 VPE0906417 5090106126 5080111321 VPE0503058 VPE1003661 VPE0502003 VPE1006713 5040227345 VPE0805279 439533 VPE0702040 VPE0503102 VPE1011763 VPE0805246 N/A VPE0602113 5080120029 VESADLCC1211040 5040227310 5080105909 5090102074 VPE0602112 VPE0503064 5080121645 475539 N/A VPE0609176 5090112495 VPE0707053 5090108706 N/A 5030852743 361131 5090111510 306459 5080111550 5090109265 VPE0609205 5080120290 VPE0602152 VPE0805276 5031221628 VPE0906416 475819 545925 VPE0602124 5090110042 VPE0710141 VPE0710142 VPE0502014 5080117524 5080118652 VPE0503089 VPE0802199 5080113324 320549 VPE0503050 VPE0802177 5040227035 5030861602 5080114800 VPE0609208 5080113030 5080118075 486565 5080115343 5090102651 5080122803 ENP1106001 361117 VPE0503103 VPE0503051 5090106398 5090106428 5090109486 VPE0503076 VPE0805270 5030852816 N/A VPE0602140 VPE0707065 5080113790 5080113049 5080111232 VPE0609163 5090105723 V",,"1,978","Vital Images, Inc. (Vital Images) received one report about potential user confusion when viewing a brain perfusion scan on Vitrea CT Brain Perfusion 2D when the scan was performed using a wide coverage shuttle acquisition technique. This may result in patient treatment delays, misdiagnosis or mistreatment.",3/15/2013,"03/15/2013",5/8/2013,"05/08/2013"
"Food",64834,"Ongoing","Purely American, Inc.","Athens","OH","US","Voluntary: Firm Initiated","Letter","Product was shipped to the following states: CT, DE, FL, GA, IL, IN, KY, MD, ME, MI, MO, NC, NE, NJ, NY, OH, PA, SD, VA & WV.","F-1509-2013","Class II","ADIRONDACK GETAWAY PASTA TOSS MIX 11oz cello bag Contents: All natural enriched semolina flour***spray dried tomato, spinach and beet powders, water, spices, dried tomatoes, black pepper, onion powder, onion flakes, and garlic.***PURELY AMERICAN 5991 Industrial Park Road, Athens, OH 45701 (800) 359-7873 www.purelyamerican.com UPC 7 92290 00164 9","ITEM #164",".","20/11 oz cello bags","The firm was notified by the Ohio Department of Agriculture that several of their labels are missing the the allergin declaration contains wheat.",3/12/2013,"03/12/2013",6/19/2013,"06/19/2013"
"Food",64834,"Ongoing","Purely American, Inc.","Athens","OH","US","Voluntary: Firm Initiated","Letter","Product was shipped to the following states: CT, DE, FL, GA, IL, IN, KY, MD, ME, MI, MO, NC, NE, NJ, NY, OH, PA, SD, VA & WV.","F-1511-2013","Class II","LONG ISLAND BAYMEN SEAFOOD CHOWDER MIX 15 oz cello bag Contents: All natural enriched semolina flour***spray dried tomato, spinach and beet powders, water, spices, dried carrots, garlic, black pepper, jalapeno peppers, bay leaf***PURELY AMERICAN 5991 Industrial Park Road, Athens, OH 45701 (800) 359-7873 www.purelyamerican.com UPC 7 92290 00178 1","ITEM #178",".","60/15 oz cello bags","The firm was notified by the Ohio Department of Agriculture that several of their labels are missing the the allergin declaration contains wheat.",3/12/2013,"03/12/2013",6/19/2013,"06/19/2013"
"Food",64834,"Ongoing","Purely American, Inc.","Athens","OH","US","Voluntary: Firm Initiated","Letter","Product was shipped to the following states: CT, DE, FL, GA, IL, IN, KY, MD, ME, MI, MO, NC, NE, NJ, NY, OH, PA, SD, VA & WV.","F-1516-2013","Class II","MARIN COUNTY CARROT CAKE MIX 18.5 oz coffee bag Contents: Unbleached white flour; whole wheat flour, sugar, spices, non-aluminum baking powder, baking soda and salt***PURELY AMERICAN 5991 Industrial Park Road, Athens, OH 45701 (800) 359-7873 www.purelyamerican.com UPC 7 92290 00131 6","ITEM #131",".","1/18.5 oz coffee bag","The firm was notified by the Ohio Department of Agriculture that several of their labels are missing the the allergin declaration contains wheat.",3/12/2013,"03/12/2013",6/19/2013,"06/19/2013"
"Food",64834,"Ongoing","Purely American, Inc.","Athens","OH","US","Voluntary: Firm Initiated","Letter","Product was shipped to the following states: CT, DE, FL, GA, IL, IN, KY, MD, ME, MI, MO, NC, NE, NJ, NY, OH, PA, SD, VA & WV.","F-1508-2013","Class II","Pasta Salad Mix, Contents: All natural enriched semolina flour, spray dried tomato, spinach and beet powders, water, spices, dried tomatoes, black pepper, onion powder, onion flakes and garlic***PURELY AMERICAN 5991 Industrial Park Road, Athens, OH 45701 (800) 359-7873 www.purelyamerican.com'' Sold under the brand names: LIGHTS OF LAKE ERIE 10 oz cello bag, UPC 7 92290 00188 0, LIGHTS OF CAROLINA 10 oz cello bag, UPC 7 92290 00155 2, LIGHTS OF THE CHESAPEAKE 11 oz cello bag, UPC 7 92290 00160 6 and LIGHTS OF LAKE MICHIGAN 11 oz cello bag UPC 7 92290 00169 9","ITEM #188, ITEM #155, ITEM #160 and ITEM #169",".","163/10 oz cello bags & 176/11 oz cello bags","The firm was notified by the Ohio Department of Agriculture that several of their labels are missing the the allergin declaration contains wheat.",3/12/2013,"03/12/2013",6/19/2013,"06/19/2013"
"Food",64834,"Ongoing","Purely American, Inc.","Athens","OH","US","Voluntary: Firm Initiated","Letter","Product was shipped to the following states: CT, DE, FL, GA, IL, IN, KY, MD, ME, MI, MO, NC, NE, NJ, NY, OH, PA, SD, VA & WV.","F-1515-2013","Class II","SHENANDOAH VALLEY APPLE AND SPICE CAKE MIX 15.5 oz coffee bag Contents: Unbleached white flour; cane sugar, spices, non-aluminum baking powder, baking soda and salt***PURELY AMERICAN 5991 Industrial Park Road, Athens, OH 45701 (800) 359-7873 www.purelyamerican.com UPC 7 92290 00121 7","ITEM #121",".","230/15.5 oz coffee bags","The firm was notified by the Ohio Department of Agriculture that several of their labels are missing the the allergin declaration contains wheat.",3/12/2013,"03/12/2013",6/19/2013,"06/19/2013"
"Food",64834,"Ongoing","Purely American, Inc.","Athens","OH","US","Voluntary: Firm Initiated","Letter","Product was shipped to the following states: CT, DE, FL, GA, IL, IN, KY, MD, ME, MI, MO, NC, NE, NJ, NY, OH, PA, SD, VA & WV.","F-1510-2013","Class II","GILROY GARLIC PASTA STIR FRY MIX 11oz cello bag Contents: All natural enriched semolina flour***spray dried tomato, spinach and beet powders, water, spices, black pepper, garlic powder, salt.***PURELY AMERICAN 5991 Industrial Park Road, Athens, OH 45701 (800) 359-7873 www.purelyamerican.com UPC 7 92290 00153 8","ITEM #153",".","73/15 oz cello bags","The firm was notified by the Ohio Department of Agriculture that several of their labels are missing the the allergin declaration contains wheat.",3/12/2013,"03/12/2013",6/19/2013,"06/19/2013"
"Food",64834,"Ongoing","Purely American, Inc.","Athens","OH","US","Voluntary: Firm Initiated","Letter","Product was shipped to the following states: CT, DE, FL, GA, IL, IN, KY, MD, ME, MI, MO, NC, NE, NJ, NY, OH, PA, SD, VA & WV.","F-1512-2013","Class II","MAMA MARINO'S MINESTRONE SOUP MIX 15 oz cello bag Contents: Assorted beans & barley, Enriched semolina flour***spray dried tomato, spinach and beet powders, water, dehydrated carrots, onions, peas, tomato flakes, celery flakes, bell peppers, parsley & spices***PURELY AMERICAN 5991 Industrial Park Road, Athens, OH 45701 (800) 359-7873 www.purelyamerican.com UPC 7 92290 00105 7","ITEM #105",".","413/15 oz cello bags","The firm was notified by the Ohio Department of Agriculture that several of their labels are missing the the allergin declaration contains wheat.",3/12/2013,"03/12/2013",6/19/2013,"06/19/2013"
"Food",64834,"Ongoing","Purely American, Inc.","Athens","OH","US","Voluntary: Firm Initiated","Letter","Product was shipped to the following states: CT, DE, FL, GA, IL, IN, KY, MD, ME, MI, MO, NC, NE, NJ, NY, OH, PA, SD, VA & WV.","F-1507-2013","Class II","Pasta Salad Mix, ''10 oz cello bag, Contents: All natural enriched semolina flour, spray dried tomato, spinach and beet powders, water, parsley, celery seed, garlic, paprika, and spices***PURELY AMERICAN 5991 Industrial Park Road, Athens, OH 45701 (800) 359-7873 www.purelyamerican.com'' Sold under the brand names: PICNIC AT CAPE MAY UPC 7 92290 00143 9 and PICNIC AT FAIRMOUNT PARK UPC 7 92290 00138 5.","ITEM # CA104, ITEM #146, ITEM #143, ITEM #145 and ITEM #138",".","91/10 oz cello bags","The firm was notified by the Ohio Department of Agriculture that several of their labels are missing the the allergin declaration contains wheat.",3/12/2013,"03/12/2013",6/19/2013,"06/19/2013"
"Food",64834,"Ongoing","Purely American, Inc.","Athens","OH","US","Voluntary: Firm Initiated","Letter","Product was shipped to the following states: CT, DE, FL, GA, IL, IN, KY, MD, ME, MI, MO, NC, NE, NJ, NY, OH, PA, SD, VA & WV.","F-1506-2013","Class II","Chicken Noodle Soup Mix, ''9 oz cello bag, Contents: All natural enriched semolina flour***PURELY AMERICAN 5991 Industrial Park Road, Athens, OH 45701 (800) 359-7873 www.purelyamerican.com'' Sold under the brand names: PURELY AMERICAN SCHOOLHOUSE ON THE PRAIRIE UPC 7 92290 00179 8 and World's Best Teacher UPC 7 92290 00196 5.","ITEM # CA103 and ITEM #179",".","278/9 oz cello bags","The firm was notified by the Ohio Department of Agriculture that several of their labels are missing the the allergin declaration contains wheat.",3/12/2013,"03/12/2013",6/19/2013,"06/19/2013"
"Food",64834,"Ongoing","Purely American, Inc.","Athens","OH","US","Voluntary: Firm Initiated","Letter","Product was shipped to the following states: CT, DE, FL, GA, IL, IN, KY, MD, ME, MI, MO, NC, NE, NJ, NY, OH, PA, SD, VA & WV.","F-1514-2013","Class II","INDIAN RIVER ORANGE DROP COOKIES MIX 17 oz coffee bag Contents: Unbleached white flour; granulated sugar, confectioner's sugar, orange peel, baking powder, and salt***PURELY AMERICAN 5991 Industrial Park Road, Athens, OH 45701 (800) 359-7873 www.purelyamerican.com UPC 7 92290 00135 4","ITEM #135",".","25/17 oz coffee bags","The firm was notified by the Ohio Department of Agriculture that several of their labels are missing the the allergin declaration contains wheat.",3/12/2013,"03/12/2013",6/19/2013,"06/19/2013"
"Food",64834,"Ongoing","Purely American, Inc.","Athens","OH","US","Voluntary: Firm Initiated","Letter","Product was shipped to the following states: CT, DE, FL, GA, IL, IN, KY, MD, ME, MI, MO, NC, NE, NJ, NY, OH, PA, SD, VA & WV.","F-1513-2013","Class II","SANTA FE CORNBREAD MIX 12.25 oz coffee bag Contents: Yellow corn meal, unbleached white flour; dehydrated garlic, onion, paprika, bell peppers, celery & parsley flakes, non-aluminum baking powder, baking soda, salt***PURELY AMERICAN 5991 Industrial Park Road, Athens, OH 45701 (800) 359-7873 www.purelyamerican.com UPC 7 92290 00126 2","ITEM #126",".","63/12.25 oz coffee bags","The firm was notified by the Ohio Department of Agriculture that several of their labels are missing the the allergin declaration contains wheat.",3/12/2013,"03/12/2013",6/19/2013,"06/19/2013"
"Drugs",64835,"Ongoing","Pfizer Inc.","New York","NY","US","Voluntary: Firm Initiated","Letter","Nationwide and PR","D-252-2013","Class II","Levoxyl (levothyroxine sodium) tablets, USP 50 mcg, packaged in a) 100-count bottles (NDC 60793-851-01) and b) 1000-count bottles ( NDC 60793-851-10 ) Rx only, Manufactured and Distributed by: King Pharmaceuticals, Inc., Bristol, TN 37620.","Lot # a) 66730B, 66853B, Exp. 01/14; b) 66731B, 67116B, Exp. 11/13, 66856B, Exp. 12/13; 67341B, Exp, 02/14 ",".","29613 bottles","Chemical contamination: emission of strong odor after package was opened.",3/28/2013,"03/28/2013",4/24/2013,"04/24/2013"
"Drugs",64835,"Ongoing","Pfizer Inc.","New York","NY","US","Voluntary: Firm Initiated","Letter","Nationwide and PR","D-261-2013","Class II","Levoxyl (levothyroxine sodium) tablets, USP 200 mcg, packaged in a) 100-count bottles (NDC 60793-860-01) and b) 1000-count bottles ( NDC 60793-860-10 ) Rx only, Manufactured and Distributed by: King Pharmaceuticals, Inc., Bristol, TN 37620.","Lot # a) 66671B, Exp. 11/13; 67512B, Exp. 02/14 b) 66739B Exp. 11/13; 67513B Exp. 02/14 ",".","14464 bottles","Chemical contamination: emission of strong odor after package was opened.",3/28/2013,"03/28/2013",4/24/2013,"04/24/2013"
"Drugs",64835,"Ongoing","Pfizer Inc.","New York","NY","US","Voluntary: Firm Initiated","Letter","Nationwide and PR","D-259-2013","Class II","Levoxyl (levothyroxine sodium) tablets, USP 150 mcg, packaged in a) 100-count bottles (NDC 60793-858-01) and b) 1000-count bottles ( NDC 60793-858-10 ) Rx only, Manufactured and Distributed by: King Pharmaceuticals, Inc., Bristol, TN 37620.","Lot # a) 66375B, Exp. 10/13; 66719B, Exp. 01/14; b) 66904B, Exp. 01/14 ",".","36045 bottles","Chemical contamination: emission of strong odor after package was opened.",3/28/2013,"03/28/2013",4/24/2013,"04/24/2013"
"Drugs",64835,"Ongoing","Pfizer Inc.","New York","NY","US","Voluntary: Firm Initiated","Letter","Nationwide and PR","D-258-2013","Class II","Levoxyl (levothyroxine sodium) tablets, USP 137 mcg, packaged in a) 100-count bottles (NDC 60793-857-01) and b) 1000-count bottles ( NDC 60793-857-10 ) Rx only, Manufactured and Distributed by: King Pharmaceuticals, Inc., Bristol, TN 37620.","Lot # a) 67013B, Exp. 01/14; b) 66900B, Exp. 01/14 ",".","7901 bottles","Chemical contamination: emission of strong odor after package was opened.",3/28/2013,"03/28/2013",4/24/2013,"04/24/2013"
"Drugs",64835,"Ongoing","Pfizer Inc.","New York","NY","US","Voluntary: Firm Initiated","Letter","Nationwide and PR","D-257-2013","Class II","Levoxyl (levothyroxine sodium) tablets, USP 125 mcg, packaged in a) 100-count bottles (NDC 60793-856-01) and b) 1000-count bottles ( NDC 60793-856-10 ) Rx only, Manufactured and Distributed by: King Pharmaceuticals, Inc., Bristol, TN 37620.","Lot # a) 66373B, Exp. 10/13; 66851B, Exp. 12/13; b)66792B, Exp. 12/13; 67349B, Exp. 03/14",".","37891 bottles","Chemical contamination: emission of strong odor after package was opened",3/28/2013,"03/28/2013",4/24/2013,"04/24/2013"
"Drugs",64835,"Ongoing","Pfizer Inc.","New York","NY","US","Voluntary: Firm Initiated","Letter","Nationwide and PR","D-253-2013","Class II","Levoxyl (levothyroxine sodium) tablets, USP 75 mcg, packaged in a) 100-count bottles (NDC 60793-852-01) and b) 1000-count bottles ( NDC 60793-852-10 ) Rx only, Manufactured and Distributed by: King Pharmaceuticals, Inc., Bristol, TN 37620.","Lot # a) 66369B, Exp. 10/13; 66679B, Exp. 11/13; 66850B, Exp. 12/13; b) 66676B, 66732B, Exp. 12/13; 67136B, Exp. 03/14 ",".","37809 bottles","Chemical contamination: emission of strong odor after package was opened.",3/28/2013,"03/28/2013",4/24/2013,"04/24/2013"
"Drugs",64835,"Ongoing","Pfizer Inc.","New York","NY","US","Voluntary: Firm Initiated","Letter","Nationwide and PR","D-255-2013","Class II","Levoxyl (levothyroxine sodium) tablets, USP 100 mcg, packaged in a) 100-count bottles (NDC 60793-854-01) and b) 1000-count bottles ( NDC 60793-854-10 ) Rx only, Manufactured and Distributed by: King Pharmaceuticals, Inc., Bristol, TN 37620.","Lot # a) 66897B, Exp. 12/13; b) 67137B, Exp.02/14 ",".","18195 bottles","Chemical contamination: emission of strong odor after package was opened..",3/28/2013,"03/28/2013",4/24/2013,"04/24/2013"
"Drugs",64835,"Ongoing","Pfizer Inc.","New York","NY","US","Voluntary: Firm Initiated","Letter","Nationwide and PR","D-254-2013","Class II","Levoxyl (levothyroxine sodium) tablets, USP 88 mcg, packaged in a) 100-count bottles (NDC 60793-853-01) and b) 1000-count bottles ( NDC 60793-853-10 ) Rx only, Manufactured and Distributed by: King Pharmaceuticals, Inc., Bristol, TN 37620.","Lot # a) 66619B, Exp. 11/13; 67010B, Exp. 01/14; b) 66733B, Exp. 11/13; 67441B, Exp. 01/14 ",".","26447 bottles","Chemical contamination: emission of strong odor after package was opened..",3/28/2013,"03/28/2013",4/24/2013,"04/24/2013"
"Drugs",64835,"Ongoing","Pfizer Inc.","New York","NY","US","Voluntary: Firm Initiated","Letter","Nationwide and PR","D-251-2013","Class II","Levoxyl (levothyroxine sodium) tablets, USP 25 mcg, packaged in a) 100-count bottles (NDC 60793-850-01) and b) 1000-count bottles ( NDC 60793-850-10 ) Rx only, Manufactured and Distributed by: King Pharmaceuticals, Inc., Bristol, TN 37620.","Lot # a) 66675B, Exp. 10/13; b) 66852B Exp. 10/13; 67138B, Exp. 02/14 ",".","23210 bottles","Chemical contamination: emission of strong odor after package was opened..",3/28/2013,"03/28/2013",4/24/2013,"04/24/2013"
"Drugs",64835,"Ongoing","Pfizer Inc.","New York","NY","US","Voluntary: Firm Initiated","Letter","Nationwide and PR","D-256-2013","Class II","Levoxyl (levothyroxine sodium) tablets, USP 112 mcg, packaged in a) 100-count bottles (NDC 60793-855-01) and b) 1000-count bottles ( NDC 60793-855-10 ) Rx only, Manufactured and Distributed by: King Pharmaceuticals, Inc., Bristol, TN 37620.","Lot # a) 67343B, Exp. 01/14; b) 66902B, Exp. 12/13 ",".","9213 bottles","Chemical contamination: emission of strong odor after package was opened.",3/28/2013,"03/28/2013",4/24/2013,"04/24/2013"
"Drugs",64835,"Ongoing","Pfizer Inc.","New York","NY","US","Voluntary: Firm Initiated","Letter","Nationwide and PR","D-260-2013","Class II","Levoxyl (levothyroxine sodium) tablets, USP 175 mcg, packaged in a) 100-count bottles (NDC 60793-859-01) and b) 1000-count bottles ( NDC 60793-859-10 ) Rx only, Manufactured and Distributed by: King Pharmaceuticals, Inc., Bristol, TN 37620.","Lot # a) 67507B, Exp. 02/14; b) 67508B, Exp. 02/14 ",".","10121 bottles","Chemical contamination: emission of strong odor after package was opened.",3/28/2013,"03/28/2013",4/24/2013,"04/24/2013"
"Food",64836,"Ongoing","Little Mermaid Smokehouse","North Hollywood","CA","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","California.","F-1316-2013","Class I","Little Mermaid Brand Smoked Herring. ","No codes. Products sold prior to 04/04/2013.",".","approximately 12.81 lbs","During an inspection by FDA, it was found that the Little Mermaid Smoked Herring and Little Mermaid Pickled Herring were uneviscerated. The firm initiated the recall due to potential for Clostridium botulinum.",4/4/2013,"04/04/2013",4/24/2013,"04/24/2013"
"Food",64836,"Ongoing","Little Mermaid Smokehouse","North Hollywood","CA","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","California.","F-1317-2013","Class I","Little Mermaid Brand Pickled Herring. ","No codes. Products sold prior to 04/04/2013.",".","approximately 44.5 lbs","During an inspection by FDA, it was found that the Little Mermaid Smoked Herring and Little Mermaid Pickled Herring were uneviscerated. The firm initiated the recall due to potential for Clostridium botulinum.",4/4/2013,"04/04/2013",4/24/2013,"04/24/2013"
"Devices",64837,"Ongoing","Hospira Inc.","Lake Forest","IL","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution - USA (nationwide) and internationally to Australia, New Zealand, China, Hong Kong, Taiwan, Japan, Korea, Philippines, Thailand, Malaysia, Canada, Austria, Bahrain, Belgium, Croatia, Denmark, Egypt, Finland, France, Germany, Gibraltar, Greece, Hungary, Iceland, Ireland, Israel, Italy, Jordan, Kuwait, Lebanon, Libya, Luxembourg, Malta, Netherlands, Norway, Oman, Portugal, Qatar, Romania, Saudi Arabia, Slovenia, South Africa, Spain, Sweden, Switzerland, Turkey, UK, United Arab Emirates, Brazil, Chile and Colombia.","Z-1169-2013","Class I","The GemStar Pump is a small and lightweight, single channel infusion device designed for use in the home, in the hospital, or anywhere electronic infusion is required. The GemStar Pump can be powered by AC mains adaptor, rechargeable battery pack, docking station, or two disposable AA alkaline batteries. When powered by batteries, The GemStar Pump is ideal for ambulatory patients. The GemStar Pump is a small and lightweight, single channel infusion device designed for use in the home, in the hospital, or anywhere electronic infusion is required.","List Numbers: 13000, 13100, 13150",,"List Number 13000: 25,119 pumps; List Number 13100: 185 pumps; List Number 13150: 13,497 pumps ","Pump shutting off during use without warning. ",3/18/2013,"03/18/2013",5/8/2013,"05/08/2013"
"Devices",64837,"Ongoing","Hospira Inc.","Lake Forest","IL","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution - USA (nationwide) and internationally to Australia, New Zealand, China, Hong Kong, Taiwan, Japan, Korea, Philippines, Thailand, Malaysia, Canada, Austria, Bahrain, Belgium, Croatia, Denmark, Egypt, Finland, France, Germany, Gibraltar, Greece, Hungary, Iceland, Ireland, Israel, Italy, Jordan, Kuwait, Lebanon, Libya, Luxembourg, Malta, Netherlands, Norway, Oman, Portugal, Qatar, Romania, Saudi Arabia, Slovenia, South Africa, Spain, Sweden, Switzerland, Turkey, UK, United Arab Emirates, Brazil, Chile and Colombia.","Z-1170-2013","Class I","The GemStar Pump is a small and lightweight, single channel infusion device designed for use in the home, in the hospital, or anywhere electronic infusion is required. The GemStar Pump can be powered by AC mains adaptor, rechargeable battery pack, docking station, or two disposable AA alkaline batteries. When powered by batteries, The GemStar Pump is ideal for ambulatory patients. The GemStar Pump is a small and lightweight, single channel infusion device designed for use in the home, in the hospital, or anywhere electronic infusion is required. ","List Numbers: 13086, 13087, 13088",,"List Number 13086: 286 pumps; List Number 13087: 45,376 pumps; List Number 13088: 23,942 pumps","Pump shutting off during use without warning. ",3/18/2013,"03/18/2013",5/8/2013,"05/08/2013"
"Drugs",64838,"Ongoing","Consumer Concepts, Inc.","Roscoe","IL","US","Voluntary: Firm Initiated","E-Mail","Nationwide","D-325-2013","Class I","ROCK-IT MAN capsules, male sexual stimulant, packaged in 1-count (UPC 8 53447 02003 8) and 2-count (UPC 8 53447 00204 1) blister cards, Distributed by Consumer Concepts.","All product sold between 01/01/13 through 03/27/13.",,"11,424 blister packs","Marketed Without An Approved NDA/ANDA: FDA analysis found the product to contain hydroxythiohomosildenafil, an analogue of sildenafil which is an ingredient in an FDA-approved drug for the treatment of male erectile dysfunction, making this an unapproved new drug.",4/1/2013,"04/01/2013",5/22/2013,"05/22/2013"
"Devices",64839,"Ongoing","Hospira Inc.","Lake Forest","IL","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution - USA (nationwide) Australia, New Zealand, China, Hong Kong, Taiwan, Japan, Korea, Philippines, Thailand, Malaysia, Canada, Austria, Bahrain, Belgium, Croatia, Denmark, Egypt, Finland, France, Germany, Gibraltar, Greece, Hungary, Iceland, Ireland, Israel, Italy, Jordan, Kuwait, Lebanon, Libya, Luxembourg, Malta, Netherlands, Norway, Oman, Portugal, Qatar, Romania, Saudi Arabia, Slovenia, South Africa, Spain, Sweden, Switzerland, Turkey, UK, United Arab Emirates, Brazil, Chile and Colombia.","Z-1160-2013","Class I","GemStar Pump - Battery Product Usage: The GemStar Pump is a small and lightweight, single channel infusion device designed for use in the home, in the hospital, or anywhere electronic infusion is required. The GemStar Pump can be powered by AC mains adaptor, rechargeable battery pack, docking station, or two disposable AA alkaline batteries. When powered by batteries, The GemStar Pump is ideal for ambulatory patients.","List Numbers: 13086, 13087, 13088",,"List Number 13086: 286 pumps; List Number 13087: 45,376 pumps; List Number 13088: 23,492 pumps","Battery level lower then 2.4 volts results in corrupt history log and loss of data for preview therapy's parameters and causes an 11/004 error resulting in the pump not being able to be used. ",3/18/2013,"03/18/2013",5/8/2013,"05/08/2013"
"Devices",64839,"Ongoing","Hospira Inc.","Lake Forest","IL","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution - USA (nationwide) Australia, New Zealand, China, Hong Kong, Taiwan, Japan, Korea, Philippines, Thailand, Malaysia, Canada, Austria, Bahrain, Belgium, Croatia, Denmark, Egypt, Finland, France, Germany, Gibraltar, Greece, Hungary, Iceland, Ireland, Israel, Italy, Jordan, Kuwait, Lebanon, Libya, Luxembourg, Malta, Netherlands, Norway, Oman, Portugal, Qatar, Romania, Saudi Arabia, Slovenia, South Africa, Spain, Sweden, Switzerland, Turkey, UK, United Arab Emirates, Brazil, Chile and Colombia.","Z-1159-2013","Class I","GemStar Pump - Battery Product Usage: The GemStar Pump is a small and lightweight, single channel infusion device designed for use in the home, in the hospital, or anywhere electronic infusion is required. The GemStar Pump can be powered by AC mains adaptor, rechargeable battery pack, docking station, or two disposable AA alkaline batteries. When powered by batteries, The GemStar Pump is ideal for ambulatory patients.","List Numbers: 13000, 13100, 13150",,"List Number 13000: 25,119 pumps; List Number 13100: 185 pumps; List Number 13150: 13,497 pumps","Battery level lower then 2.4 volts results in corrupt history log and loss of data for preview therapy's parameters and causes an 11/004 error resulting in the pump not being able to be used. ",3/18/2013,"03/18/2013",5/8/2013,"05/08/2013"
"Devices",64840,"Ongoing","Acist Medical Systems","Eden Prairie","MN","US","Voluntary: Firm Initiated","Letter","Nationwide Distribution including the states of AL, AK, AZ, AR, CA, CO, CT, DC, GA, HI, ID, IL, IN, IA, KS, KY, MD,MI, MN, MS, MO, NV, NH, NJ, NM, NY,NC, OR, OK, OH, PA, TN, TX, VA and WA.","Z-1145-2013","Class II","ACIST Medical Systems Inc. The ACIST Angiographic Injection System is intended to be used for the controlled infusion of radiopaque contrast media for angiographic procedures. ","23884007, 23884008, 23884009",".","6640 units","ACIST Medical Systems is issuing a voluntary recall notice for three specific lots of BT2000 Automated Manifold Kits. For these specific lots, ACIST has received field reports related to ingress of air into the manifold body. This has been detected by the Air Column Detect Sensor halting the injection, and normally replacement of the BT2000 Automated Manifold Kit is necessary in order to proceed with the injection. To date, there has been no evidence or report of any air injection to a patient, injury or adverse health consequence associated with this issue.",3/15/2013,"03/15/2013",4/24/2013,"04/24/2013"
"Devices",64841,"Ongoing","Hospira Inc.","Lake Forest","IL","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution - USA (nationwide) and Internationally to Australia, New Zealand, China, Hong Kong, Taiwan, Japan, Korea, Philippines, Thailand, Malaysia, Canada, Austria, Bahrain, Belgium, Croatia, Denmark, Egypt, Finland, France, Germany, Gibraltar, Greece, Hungary, Iceland, Ireland, Israel, Italy, Jordan, Kuwait, Lebanon, Libya, Luxembourg, Malta, Netherlands, Norway, Oman, Portugal, Qatar, Romania, Saudi Arabia, Slovenia, South Africa, Spain, Sweden, Switzerland, Turkey, UK, United Arab Emirates, Brazil, Chile and Colombia.","Z-1117-2013","Class II","The GemStar Pump is a small and lightweight, single channel infusion device designed for use in the home, in the hospital, or anywhere electronic infusion is required. The GemStar Pump can be powered by AC mains adaptor, rechargeable battery pack, docking station, or two disposable AA alkaline batteries. When powered by batteries, The GemStar Pump is ideal for ambulatory patients.","List Numbers: 13086, 13087, 13088",".","1) List Number 13086: 286 pumps; 3) List Number 13087: 45,376 pumps; 4) List Number 13088: 23,492 pumps ","During infusions of 2.0 mL/hr the motor assembly may rotate backwards capturing additional medication resulting in over-infusion. ",3/21/2013,"03/21/2013",4/24/2013,"04/24/2013"
"Devices",64841,"Ongoing","Hospira Inc.","Lake Forest","IL","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution - USA (nationwide) and Internationally to Australia, New Zealand, China, Hong Kong, Taiwan, Japan, Korea, Philippines, Thailand, Malaysia, Canada, Austria, Bahrain, Belgium, Croatia, Denmark, Egypt, Finland, France, Germany, Gibraltar, Greece, Hungary, Iceland, Ireland, Israel, Italy, Jordan, Kuwait, Lebanon, Libya, Luxembourg, Malta, Netherlands, Norway, Oman, Portugal, Qatar, Romania, Saudi Arabia, Slovenia, South Africa, Spain, Sweden, Switzerland, Turkey, UK, United Arab Emirates, Brazil, Chile and Colombia.","Z-1116-2013","Class II","The GemStar Pump is a small and lightweight, single channel infusion device designed for use in the home, in the hospital, or anywhere electronic infusion is required. The GemStar Pump can be powered by AC mains adaptor, rechargeable battery pack, docking station, or two disposable AA alkaline batteries. When powered by batteries, The GemStar Pump is ideal for ambulatory patients.","List Numbers: 13000, 13100, 13150",".","1) List Number 13000: 25,119 pumps; 2) List Number 13100: 185 pumps; 3) List Number 13150: 13,497 pumps","During infusions of 2.0 mL/hr the motor assembly may rotate backwards capturing additional medication resulting in over-infusion. ",3/21/2013,"03/21/2013",4/24/2013,"04/24/2013"
"Biologics",64842,"Terminated","American National Red Cross","Boise","ID","US","Voluntary: Firm Initiated","Telephone","Nevada; Pennsylvania; Maryland; Virginia; District of Columbia; California; Idaho; Montana","B-1544-13","Class III","Blood and Blood Products for Reprocessing","20GS49322; 20GS49377; 20GS49493; 20GS49495; 20GY55895; 20GY56039; 20GY55598; 20GY55610; 20FP12306; 20GS48814; 20GS49166; 20GH75559; 20GS48838; 20GS49245; 20GY55041; 20GY55126 ",".","16 units","Blood products, collected from an ineligible donor, were distributed. ",2/19/2013,"02/19/2013",6/12/2013,"06/12/2013"
"Biologics",64842,"Terminated","American National Red Cross","Boise","ID","US","Voluntary: Firm Initiated","Telephone","Nevada; Pennsylvania; Maryland; Virginia; District of Columbia; California; Idaho; Montana","B-1543-13","Class II","Plasma Frozen within 24 hours (FP24)","20GY55052; 20GY55090; 20GY55096; 20GY55097",".","4 units","Blood products, collected from an ineligible donor, were distributed. ",2/19/2013,"02/19/2013",6/12/2013,"06/12/2013"
"Biologics",64842,"Terminated","American National Red Cross","Boise","ID","US","Voluntary: Firm Initiated","Telephone","Nevada; Pennsylvania; Maryland; Virginia; District of Columbia; California; Idaho; Montana","B-1545-13","Class II","Red Blood Cells Leukocytes Reduced","20GS49322; 20GS49377; 20GS49493; 20GS49495; 20GY55895; 20GY56039; 20GY56426; 20FP12306; 20GH75559; 20GS48814; 20GS48838; 20GS49166; 20GS49245; 20GY55041; 20GY55052; 20GY55090; 20GY55096; 20GY55097; 20GY55126; 20GY55598; 20GY55610",".","21 units","Blood products, collected from an ineligible donor, were distributed. ",2/19/2013,"02/19/2013",6/12/2013,"06/12/2013"
"Biologics",64843,"Terminated","Mississippi Blood Services Inc.","Flowood","MS","US","Voluntary: Firm Initiated","FAX","Mississippi; Switzerland","B-1622-13","Class III","Blood and Blood Products for Reprocessing","W069112100292; ",,"1","Blood products, collected from a donor whose suitability to donate was not adequately determined, were distributed.",3/6/2013,"03/06/2013",7/3/2013,"07/03/2013"
"Biologics",64843,"Terminated","Mississippi Blood Services Inc.","Flowood","MS","US","Voluntary: Firm Initiated","FAX","Mississippi; Switzerland","B-1621-13","Class II","Red Blood Cells Leukocytes Reduced","W069112100292; ",,"1","Blood products, collected from a donor whose suitability to donate was not adequately determined, were distributed.",3/6/2013,"03/06/2013",7/3/2013,"07/03/2013"
"Biologics",64844,"Terminated","BloodSource, Inc.","Mather","CA","US","Voluntary: Firm Initiated","E-Mail","Austria; California","B-1672-13","Class III","Blood and Blood Products for Reprocessing","W035809225308; W035811160557; W035811088380; W035810480891; W035810351796; W035808122086; W035808040583; LR55337; GG43148; LQ20765; LQ00760; LM40001; ",,"12","Blood products, collected from a donor who was previously deferred for a positive HIV test result, were distributed. ",2/18/2013,"02/18/2013",7/3/2013,"07/03/2013"
"Biologics",64844,"Terminated","BloodSource, Inc.","Mather","CA","US","Voluntary: Firm Initiated","E-Mail","Austria; California","B-1671-13","Class II","Red Blood Cells Leukocytes Reduced","W035811160557; W035811088380; W035810480891; W035810351796; W035809225308; W035808122086; W035808040583; LR55337; GG43148; LQ20765; LQ00760; LM40001; ",,"12","Blood products, collected from a donor who was previously deferred for a positive HIV test result, were distributed. ",2/18/2013,"02/18/2013",7/3/2013,"07/03/2013"
"Biologics",64845,"Terminated","Marquette General Hospital, Inc, UP Reg Bl Ctr Marquette","Marquette","MI","US","Voluntary: Firm Initiated","Telephone","Michigan","B-1758-13","Class II","Red Blood Cells Leukocytes Reduced","W121013003828; ",".","1","Blood product, with an unacceptable low volume which was not labeled as a low volume unit, was distributed. ",3/25/2013,"03/25/2013",7/24/2013,"07/24/2013"
"Drugs",64846,"Ongoing","Actavis South Atlantic LLC","Sunrise","FL","US","Voluntary: Firm Initiated","Letter","Nationwide","D-248-2013","Class III","buPROPion Hydrochloride Extended-Release Tablets (XL) 300 mg, 30-count tablets per bottle, Rx only, Distributed by: Actavis South Atlantic LLC, Sunrise, FL 33325; Packaged by: American Health Packaging, Columbus, OH 43217; NDC 67767-142-30.","Lot #: CC1D11A, CC1D12A, CC1D17A, CC1D18A, CD1D05A, CD1D07A, CD1D08A, CD1D14A, CD1D15A, CD1D16A, CE1D08A, Exp 03/13; CE1D03A, CE1D04A, CE1D07A, CE1D06A, CE1D05A, CE1D13A, CE1D14A, CE1D15A, Exp 04/13; CF1D01A, CE1D24A, CF1D02A, Exp 05/13; CH1D08A, CH1D09A, Exp 07/13; CJ1D01A, CH1D11A, CH1D10A, CJ1D09A, CJ1D02A, CJ1D10A Exp 08/13; CL1D05A, CL1D06A, CK1D05B, CK1D06A, Exp 10/13; CL1D08A, CM1D01A, CM1D02A, Exp 11/13",".","555,672 bottles","Failed USP Dissolution Test Requirements: Out-of-specification dissolution results at the 8 hour stability testing point.",3/20/2013,"03/20/2013",4/24/2013,"04/24/2013"
"Biologics",64847,"Terminated","University Of Miami Miller School of Medicine Tissue Bank","Miami","FL","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Florida and Texas","B-2266-13","Class III","Bone","UBO008514008211; UBO008514008011; UBO008514008111",".","3","Human tissue allografts, mislabeled with extended expiration dates, were distributed. ",3/20/2013,"03/20/2013",9/11/2013,"09/11/2013"
"Devices",64848,"Ongoing","Heritage Labs International LLC","Olathe","KS","US","Voluntary: Firm Initiated","Letter","Nationwide Distribution including the states of AL, CA, GA, IL, IN, KY, MA, MD, NC, NY, OK and VA.","Z-1131-2013","Class II","Heritage Labs Path Study Extra Supplies Kit, Product # A 2376, kit contains 3 zippered plastic bags which hold support supplies for health care providers when treating patients. Bag #3 contains 5 different blood collection tubes (5 each) and 2 different gauge needles--all for drawing blood. One of the tubes is the recalled BD blue top citrate tube (5 tubes). These tubes were manufactured by BD, Franklin Lakes, NJ. The kit is used by health care providers when treating patients. ","Lot A2376-12307, exp 2/28/2013 and Lot A2376-12272, exp 4/30/2013",".","25 kits","The product has a Lithium Heparin contaminant which could adversely affect coagulation results potentially causing erroneous lab results.",2/6/2013,"02/06/2013",4/24/2013,"04/24/2013"
"Biologics",64849,"Ongoing","Immucor Inc","Norcross","GA","US","Voluntary: Firm Initiated","Letter","Nationwide; Brazil, China, Costa Rica, Germany, Hong Kong, India, Ireland, Mexico, Singapore, Taiwan","B-1482-13","Class III","Capture-P Indicator Red Cells package 1 x 11.5 mL","Lot Nos. 226192, 22613, 226194",".","3 units","Capture-P and Capture-P Ready Screen assays, with confirmed reduced reactivity with the weak positive control, were distributed. ",3/26/2013,"03/26/2013",6/12/2013,"06/12/2013"
"Devices",64850,"Ongoing","Roche Diagnostics Operations, Inc.","Indianapolis","IN","US","Voluntary: Firm Initiated",,"USA Nationwide Distribution","Z-1368-2013","Class II","Cobas 8000 modular analyzer series software version 03-01, 02, 03 and 04, impacting the cobas e 602 module only. Product Usage: Fully automated immunoassay analyzer intended for the in-vitro quantitative/qualitative determination of analytes in body fluids. This analyzer is optimized for high throughput workloads in the professional environment using a combination of ion selective electrodes and photometric analysis modules ","Part Number 05990378001 Serial Numbers 1017-06, 1021-03, 1021-05, 1142-09, 1145-10, 1140-01, 1125-07, 1128-02, 1146-01, 1146-02, 1146-03, 1171-10, 1169-06, 1169-08, 1169-09, 1172-09, 1156-01, 1156-02, 1156-09, 1160-04, 1160-06, 1016-05, 1017-01, 1139-08, 1139-10, 1140-07, 1140-08, 1140-10, 1156-06, 1156-07, 1158-09, 1160-01, 1160-05, 1173-01, 1139-06, 1139-07, 2374-11, 1127-08, 1138-08, 1138-10, 1139-01, 1156-08, 1156-10, 1173-10, 1156-05, 1158-10, 1139-09, 1131-08, 1132-01, 1132-02, 1171-07, 1171-08, 1171-09, 1147-05, 1149-01, 1124-05, 1124-06, 1132-03, 1132-04, 1147-05, 1149-01, 1128-05, 1128-06, 1139-02, 1139-03, 1139-04, 1139-05, 1146-05, 1146-06, 1147-04, 1156-04, 1132-05, 1132-10, 1137-02, 1147-05, 1149-01, 1128-05, 1128-06, 1149-07, 1149-08, and 1167-02. ",".","72 units","When using the cobas e 602 module, Diluent Multiassay may be used for autodilution of certain assays instead of Diluent Universal. This may cause incorrect results under specific circumstances if all of the following conditions are met simultaneously: More than a total of 2000 reagent kits or diluents have been registered on the cobas e 602 modules within one system core, and two different diluents are on board the module in parallel (i.e., Diluent Universal and Diluent MultiAssay), and Diluent Universal previously registered correctly is now being registered as Diluent MultiAssay, or vice versa. ",4/4/2013,"04/04/2013",5/29/2013,"05/29/2013"
"Devices",64851,"Ongoing","Newport Medical Instruments Inc","Costa Mesa","CA","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution - USA including US (AL, AR, AZ, CA, CO, CT, DE, FL, GA, lA, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MT, NC, NH, NJ, NV, NY, OH, OK, OR, PA, Puerto Rico, RI, SC, TN, TX, UT, VA, WA, and WI. Internationally to Argentina, Australia, Bangladesh, Belgium, BoliVia, Brazil, Bulgaria, Canada, Chile, China, Colombia, Costa Rica, Croatia, Ecuador, Egypt, France, Greece, Hong Kong, Hungary, India, Indonesia, Israel, Ireland, Italy, Japan, Kazakhstan, Kosova, Lebanon, Lithuania, Malaysia, Mexico, Nambia, Nepal, Norway, Oman, Paraguay, Peru, Philippines, Poland, Qatar, Saudi Arabia, Singapore, South Africa, South Korea, Sri Lanka, Switzerland, Taiwan, Thailand, Turkey, United Arab Emirates, United Kingdom, Venezuela, and Viet Nam.","Z-1171-2013","Class I","Newport Medical Instruments HT70 and HT70 Plus ventilator Power Pac batteries Model number: HT70 and HT70 Plus. The HT70 and HT70 Plus ventilator systems are intended to provide continuous or intermittent positive pressure mechanical ventilatory support for the care of individuals who require mechanical ventilation through invasive or non-invasive interfaces. ","Model number: HT70 and HT70 Plus Power Pac battery serial number range: 2096134110001 to 2292048120050, Rev. C through Rev. F",,"2528 ventilators and 1864 power pac batteries","Newport Medical Instruments is conducting a voluntary recall on certain Newport Medical Instruments HT70 and HT70 Plus ventilator Power Pac batteries due to customer reports of Newport HT70 and HT70 Plus ventilators alarming and going to internal backup battery sooner than expected while the ventilator is being operated on Power Pac battery.",4/5/2013,"04/05/2013",5/8/2013,"05/08/2013"
"Devices",64852,"Ongoing","Remel Inc","Lenexa","KS","US","Voluntary: Firm Initiated","Letter","US Distribution including the states of AL, AR, CA, FL, GA, IL, KS, LA, MA, MD, NY, OK, PA, RI, TX, VA, and WA.","Z-2081-2013","Class III","Oxoid Antimicrobial Susceptibility Test Discs F300 (Nitrofurantoin), Cat. #CT0036B, packaged in cartridges of 50 discs, 5 cartridges/pack. The firm name on the label is Oxoid Ltd., Basingstoke, Hampshire, England Product is used in the semi-quantitative agar diffusion test method for in-vitro susceptibility testing.","Lots 1194944 and 1198342",,"60 packs","Use of affected lots may give false indication of susceptibility to Nitrofurantoin. ",3/25/2013,"03/25/2013",9/4/2013,"09/04/2013"
"Devices",64853,"Ongoing","US Endoscopy Group Inc","Mentor","OH","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","USA Nationwide Distribution - including the states of: AK, AL, AZ, CA, CO, CT, DE, FL, GA, ID, IA, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, NC, ND, NE, NH, NM, NV, NY, OH, OR, PA, SC, TN, TX, UT, VA, WA, WI & WV.","Z-1099-2013","Class II","Torrent'' irrigation tubing. Product Usage: The Torrent irrigation system (tubing and accessories to accommodate various endoscopes and irrigation pumps) is intended to provide irrigation via irrigation fluids, such as sterile water, during gastrointestinal endoscopic procedures when used in conjunction with an irrigation pump or electrosurgical unit.","Product code: 00711560; Lot #'s: 79687, 79688, 79689, 79690, 79691, 79692, 79693, 79694, 79695, 79696 80165, 80166, 80709, 80710, 80711, 80712, 80713, 80714, 80715, 80716, 80717, 80718, 80719. 80720, 80721, 80722, 80723, 81245, 81246, 81247, 81248, 81249, 81250, 81251, 81252, 81253, 81254, 81255, 81256, 81257, 81258, 81259, 81982, 81983, 81984, 81985, 81986, 81987, 81988, 81989, 81990, 81991, 82567, 82568, 82569, 82570, 82938, 82939, 82940, 82941, 82942, 82943, 82944, 82945, 82946, 82947, 82948, 82949, 82950, 82951, 82953, 82954, 82955, 82956, 84615, 84616, 84617, 84618, 84619, 84620, 84979, 84981, 85557, 86026, 86028, 86434, 86435 & 86436.",,"21,189 units","The firm was notified by their customers that there was a water leakage from the white tubing connector.",3/7/2013,"03/07/2013",4/17/2013,"04/17/2013"
"Biologics",64854,"Terminated","The Blood Alliance, Inc.","Jacksonville","FL","US","Voluntary: Firm Initiated","Telephone","Florida","B-1620-13","Class II","Red Blood Cells (Apheresis) Leukocytes Reduced","W118813700191; W118813700191; ",,"2","Blood products, collected from a donor who reported a post donation illness, were distributed.",2/13/2013,"02/13/2013",7/3/2013,"07/03/2013"
"Devices",64855,"Ongoing","Siemens Medical Solutions USA, Inc.","Mountain View","CA","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution - USA and countries of Australia, Austria, Bosnia Herzegovina, Belgium, Finland, France, Germany, India, Italy, Japan, Kuwait, Malaysia, Netherlands, Norway, P.R. China, Portugal, Rep.of Korea, Romania, Saudi Arabia, Spain, Sweden, Switzerland, Taiwan and United Kingdom.","Z-1081-2013","Class II","Siemens brand ACUSON SC2000 Ultrasound System, Model 10433816, hardware that contains version 4 of the MPI board 10434200; The SC2000 ultrasound imaging system is intended for the following applications: Cardiac, Neo-natal and Fetal Cardiac, Pediatric, Transespohageal, Adult Cephalic, Peripheral Vessel, Abdominal, Abdominal Intraoperative, Intraoperative Neurological, Musculo-skeletal Conventional, and Musculo-skeletal Superficial applications. The system also provides the ability to measure anatomical structures and calculation packages that provide information to the clinician that may be used adjunctively with other medical data obtained by a physician for clinical diagnosis purposes. ","All units of this model.",,"120 units","When using the V5M transducer, the display of the temperature on the ACUSON SC2000 system can be lower than the actual temperature of the V5M transducer. This occurs only if the system hardware contains revision 4 of the MPI Board. There is a potential to cause esophageal burns in patients.",3/28/2013,"03/28/2013",4/17/2013,"04/17/2013"
"Devices",64856,"Ongoing","Linde Gas North America Llc","New Providence","NJ","US","Voluntary: Firm Initiated","Letter","Nationwide distribution.","Z-1561-2013","Class II","MEDICYCL-E- Lite Portable Oxygen System An integrated portable oxygen delivery system intended to provide supplemental oxygen to adults. The device is MRI safe, MRI-compatible, and intended for use during MR Imaging for MRI systems up to 3.0 T. For emergency use only when administered by properly trained personnel for oxygen deficiency and resuscitation. For all other medical applications, Rx only.","Model : Manufacturer's #M70500037 Cataogue Number: 109855 Lot numbers: 25/07 48/06 20/03",,"52,264 units","A number of MEDICYL-e Portable Oxygen Systems may have misapplied valve flow knobs.",3/8/2013,"03/08/2013",6/26/2013,"06/26/2013"
"Drugs",64857,"Ongoing","Hi-Tech Pharmacal Co., Inc.","Amityville","NY","US","Voluntary: Firm Initiated","Letter","Puerto Rico","D-418-2013","Class III","BUCALSEP (R) ORAL SOLUTION, (Benzocaine, 600 mg, Cetylpyridinum Chloride 30 mg, Menthol 45 mg Zinc Chloride 30 mg), 1 Fl. Oz. (30 mL), Manufactured for GIL PHARMACEUTICAL CORP, PONCE, PUERTO RICO 00717-1565 -- NDC 58552-103-01","Lot 611614 (exp. 09/2013)",,"10,440 bottles","Subpotent; Cetylpyridinum Chloride",4/8/2013,"04/08/2013",5/22/2013,"05/22/2013"
"Food",64858,"Terminated","Royal Foods, Inc.","Clackamas","OR","US","Voluntary: Firm Initiated","Telephone","The two different products were distributed to two different restaurants (one for each) located in Oregon","F-1351-2013","Class III","Pantai Thai Tea The tea is packaged in a foil laminated pouch Product of Thailand","UPC 8 16125 0006 7 Lot code JCAL2010",".","4 bags - 1 lb each","During a contracted state audit of the firm several insanitary conditions were found. These include a leaking roof and rodent activities. Some products showed evidence of filth.",4/5/2013,"04/05/2013",5/1/2013,"05/01/2013"
"Food",64858,"Terminated","Royal Foods, Inc.","Clackamas","OR","US","Voluntary: Firm Initiated","Telephone","The two different products were distributed to two different restaurants (one for each) located in Oregon","F-1350-2013","Class III","Kwong Hung Seng Sauce - Thin Soy Sauce Product is packaged in bottles Net Wt 19 Fl oz - 12 bottles per case","Product shipped to one consignee 3/26/12 No lot code No UPC",".","1 case","During a contracted state audit of the firm several insanitary conditions were found. These include a leaking roof and rodent activities. Some products showed evidence of filth.",4/5/2013,"04/05/2013",5/1/2013,"05/01/2013"
"Devices",64859,"Ongoing","Encore Medical, Lp","Austin","TX","US","Voluntary: Firm Initiated","Letter","US Distribution to the state of California and International Distribution to the country of Venezuela.","Z-1213-2013","Class II","3DKnee e+ Tibial Insert. The insert is used along with the other components that comprise the 3DKnee System.","Model/Catalog Number 391-15-708. Lot/Serial Number 59602230.",,"5","U.S. Agent contacted Director Commercial Logistics, notifying him of incorrect color coded labels on two packages of e+tibial inserts. There were 8 e+ tibial inserts of the same lot number in Finished Goods as the two from the agency. These devices were inspected and all were incorrectly labeled.",4/1/2013,"04/01/2013",5/8/2013,"05/08/2013"
"Devices",64860,"Ongoing","Philips Healthcare Inc.","Andover","MA","US","Voluntary: Firm Initiated","Letter","Worldwide distribution: USA (nationwide) and countries of: Afghanistan, Albania, Argentina, Australia, Austria, Azerbaijan, Bahrain, Bangladesh, Belgium, Bolivia, Bosnia and Herzegowina, Brazil, Brunei Darussalam, Bulgaria, Canada, Cambodia, Chile, China, Colombia, Costa Rica, Croatia, Cyprus, Czech Republic, Denmark, Ecuador, Egypt, El Salvador, Estonia, Ethiopia, Finland, France, Germany, Greece, Guadeloupe, Hong Kong, Iceland, India, Indonesia, Iraq, Ireland, Israel, Italy, Japan, Jordan, Kazakhstan, Kenya, Korea, Republic Of, Kuwait, Laos, Latvia, Lebanon, Libyan Arab Jamahiriya, Lithuania, Luxembourg, Macau, Macedonia, Malaysia, Malta, Mexico, Mongolia, Morocco, Namibia, Nepal, Netherlands (Antilles), New Caledonia, New Zealand, Nicaragua, Nigera, Norway, Oman, Pakistan, Palestine, Panama, Papua New Guinea, Paraguay, Peru, Philippines, Poland, Portugal, Puerto, Rico, Qatar, Reunion, Romania, Russian Federation, Saudi Arabia, Serbia, Singapore, Slovenia, South Africa, Spain, SRI Lanka, Sweden, Switzerland, Taiwan (Province of China), Tanzania, Thailand, Trinidad and Tobago, Tunisia, Turkey, Turkmenistan, Uganda, Ukraine, United Arab Emirates, United Kingdom, Uzbekistan, Venezuela, Veit Nam, and Yemen.","Z-1189-2013","Class II","HeartStart MRx Monitor/Defribillator; Product Codes: M3536A, M3536J, M3536M, M3536MC, M3536M2, M3536M4, M3536M5, M3536M6. The HeartStart MRx is for use for the termination of ventricular tachycardia and ventricular fibrillation.","Serial numbers ranging from US00100100 to US00565942 Product Codes: M3536A, M3536J, M3536M, M3536MC, M3536M2, M3536M4, M3536M5, M3536M6 ",,"64972","Device may fail to deliver defibrillation therapy in either Manual Defib or AED mode. ",4/8/2013,"04/08/2013",5/8/2013,"05/08/2013"
"Biologics",64861,"Terminated","OneBlood / dba CBCF","Lauderhill","FL","US","Voluntary: Firm Initiated","Telephone","Florida","B-1619-13","Class II","Red Blood Cells (Apheresis) Leukocytes Reduced","1018764; 1125778; ",,"2","Blood products, collected from a donor whose suitability to donate was not adequately determined, were distributed.",4/1/2013,"04/01/2013",7/3/2013,"07/03/2013"
"Biologics",64862,"Terminated","Community Blood Center of the Ozarks","Springfield","MO","US","Voluntary: Firm Initiated","Letter","Switzerland; Missouri","B-1616-13","Class II","Red Blood Cells Leukocytes Reduced","W045112384837; ",,"1","Blood products, collected from a donor who lived with a hepatitis positive individual, were distributed.",3/21/2013,"03/21/2013",7/3/2013,"07/03/2013"
"Biologics",64862,"Terminated","Community Blood Center of the Ozarks","Springfield","MO","US","Voluntary: Firm Initiated","Letter","Switzerland; Missouri","B-1618-13","Class II","Blood and Blood Products for Reprocessing","W045112384837; ",,"1","Blood products, collected from a donor who lived with a hepatitis positive individual, were distributed.",3/21/2013,"03/21/2013",7/3/2013,"07/03/2013"
"Biologics",64862,"Terminated","Community Blood Center of the Ozarks","Springfield","MO","US","Voluntary: Firm Initiated","Letter","Switzerland; Missouri","B-1617-13","Class II","Cryoprecipitated AHF","W045112384837; ",,"1","Blood products, collected from a donor who lived with a hepatitis positive individual, were distributed.",3/21/2013,"03/21/2013",7/3/2013,"07/03/2013"
"Biologics",64863,"Terminated","Community Blood Center of Carolinas","Charlotte","NC","US","Voluntary: Firm Initiated","Telephone","North Carolina","B-1615-13","Class II","Fresh Frozen Plasma","W227012054348; ",,"1","Blood product, collected from a donor whose suitability to donate was not adequately determined, was distributed.",3/22/2013,"03/22/2013",7/3/2013,"07/03/2013"
"Biologics",64863,"Terminated","Community Blood Center of Carolinas","Charlotte","NC","US","Voluntary: Firm Initiated","Telephone","North Carolina","B-1614-13","Class II","Red Blood Cells Leukocytes Reduced","W227012054348; ",,"1","Blood product, collected from a donor whose suitability to donate was not adequately determined, was distributed.",3/22/2013,"03/22/2013",7/3/2013,"07/03/2013"
"Biologics",64864,"Terminated","Arkansas Lions Eye Bank & Laboratory","Little Rock","AR","US","Voluntary: Firm Initiated","Letter","Arkansas","B-1495-13","Class III","Cornea","1302059; 1302060; ",".","2 corneas","Human Cornea, recovered from a donor whose donor eligibility was not determined in accordance with the manufacturer's instructions, to adequately and appropriately reduce the risk of transmission of relevant communicable disease agents or diseases, was distributed. ",3/26/2013,"03/26/2013",6/12/2013,"06/12/2013"
"Biologics",64865,"Terminated","North Carolina Eye Bank, Inc. (The)","Winston Salem","NC","US","Voluntary: Firm Initiated","E-Mail","Egypt","B-1494-13","Class III","Cornea","06431301; 06431302",".","2 corneas","Human Corneas, recovered using an expired Prep Kit, were distributed. ",3/15/2013,"03/15/2013",6/12/2013,"06/12/2013"
"Biologics",64866,"Terminated","Coastal Bend Blood Center","Corpus Christi","TX","US","Voluntary: Firm Initiated","FAX","Texas","B-1613-13","Class II","Red Blood Cells (Apheresis) Leukocytes Reduced","W230813809663; W230813809663; ",".","2","Blood products, labeled leukoreduced without the assurance they met the criteria for leukoreduced products, were distributed.",2/20/2013,"02/20/2013",7/17/2013,"07/17/2013"
"Biologics",64867,"Terminated","Community Blood Center of the Ozarks","Springfield","MO","US","Voluntary: Firm Initiated","FAX","Switzerland; Austria; North Carolina; Missouri; Colorado","B-1611-13","Class II","Red Blood Cells","W045109951768; 6980871; 6882797; W045110161552; W045110143792; ",,"5","Blood products, collected from a donor whose sexual partner had a history of hepatitis B, were distributed.",2/25/2013,"02/25/2013",7/3/2013,"07/03/2013"
"Biologics",64867,"Terminated","Community Blood Center of the Ozarks","Springfield","MO","US","Voluntary: Firm Initiated","FAX","Switzerland; Austria; North Carolina; Missouri; Colorado","B-1609-13","Class II","Cryoprecipitated AHF","W045112351950; ",,"1","Blood products, collected from a donor whose sexual partner had a history of hepatitis B, were distributed.",2/25/2013,"02/25/2013",7/3/2013,"07/03/2013"
"Biologics",64867,"Terminated","Community Blood Center of the Ozarks","Springfield","MO","US","Voluntary: Firm Initiated","FAX","Switzerland; Austria; North Carolina; Missouri; Colorado","B-1612-13","Class II","Blood and Blood Products for Reprocessing","W045110143792; 6833181; W045109951768; 6980871; 6943518; 6882797; 6840218; W045112351950; W045111327405; W045111238317; W045110161552; ",,"11","Blood products, collected from a donor whose sexual partner had a history of hepatitis B, were distributed.",2/25/2013,"02/25/2013",7/3/2013,"07/03/2013"
"Biologics",64867,"Terminated","Community Blood Center of the Ozarks","Springfield","MO","US","Voluntary: Firm Initiated","FAX","Switzerland; Austria; North Carolina; Missouri; Colorado","B-1610-13","Class II","Red Blood Cells Leukocytes Reduced","6833181; 6840218; W045111238317; ",,"3","Blood products, collected from a donor whose sexual partner had a history of hepatitis B, were distributed.",2/25/2013,"02/25/2013",7/3/2013,"07/03/2013"
"Devices",64868,"Ongoing","Covidien LLC","Mansfield","MA","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution-USA (nationwide) and the countries of Korea, Japan, Canada, Australia, Brazil, Belgium, Singapore, and South Africa.","Z-1184-2013","Class II","Medi-Trace Cadence Adult Radiotransparent Defibrillation Electrode Product ID: 22550R. Intended for use in cardioversion, pacing, ECG monitoring, and defibrillation procedures. ","Lot Numbers: 226543X, 230054X , 230814X, 232182X, 232805X, 234245X, 304667X, 301844X, 300446X, 305320X",,"133470 (sets of 2)","Defibrillation Electrodes may arc/spark result in thermal damage to the leadwire, which could render the device incapable of delivering the appropriate energy or shock to the patient",4/8/2013,"04/08/2013",5/8/2013,"05/08/2013"
"Devices",64868,"Ongoing","Covidien LLC","Mansfield","MA","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution-USA (nationwide) and the countries of Korea, Japan, Canada, Australia, Brazil, Belgium, Singapore, and South Africa.","Z-1185-2013","Class II","Medi-Trace Cadence Pediatric Radiotransparent Defibrillation Electrode Product ID: 22550P. Intended for use in cardioversion, pacing, ECG monitoring, and defibrillation procedures.","Lot Numbers: 228651, 232146, 235646X, 301833X, 303928X",,"7485 (sets of 2)","Defibrillation Electrodes may arc/spark result in thermal damage to the leadwire, which could render the device incapable of delivering the appropriate energy or shock to the patient",4/8/2013,"04/08/2013",5/8/2013,"05/08/2013"
"Drugs",64869,"Ongoing","Jubilant Cadista Pharmaceuticals Inc.","Salisbury","MD","US","Voluntary: Firm Initiated",,"Nationwide","D-296-2013","Class II","Pantoprazole Sodium Delayed Release Tablets USP, 40 mg, 90 count bottles, Manufactured by Jubilant Life Sciences Ltd, Roorkee-247661 India ;Marketed by Jubilant Cadista Pharmaceuatical Inc Salisbury, MD 21801 NDC 59746-284-90","Lot PA22028 Exp 5/2014 Lot PA22029 Exp 5/2014",,"12770 bottles","cGMP Deviations: Oral products were not manufactured in accordance with Good Manufacturing Practices.",2/11/2013,"02/11/2013",5/8/2013,"05/08/2013"
"Food",64871,"Terminated","Juice Bar Solutions","Novato","CA","US","Voluntary: Firm Initiated","Letter","FL, SC, NE, RI, AZ, MD, NC, PA, MO, CA","F-1392-2013","Class III","Add a Scoop by Smoothie Essentials; Probiotic; Supports Digestive Health, dietary supplement; Net Weight: 1 lb (464g) 16 oz. Contains Bacillus Coagulans GBI-30-6086 in a base of Maltdextrin. Gluten Free, GMO Free Manufactured for: Juice Bar Solutions, 38 Maybeck St., Novato, Ca 94949. Product of USA","Lot # 120615, Best by 8/2014; UPC 6 88683 10800 0",,"26 containers","It was discovered that label for Add a Scoop Probiotic stated that it was GMO free, however manufacturers paperwork did not support the claim.",3/4/2013,"03/04/2013",5/22/2013,"05/22/2013"
"Biologics",64872,"Terminated","The Blood Connection, Inc.","Piedmont","SC","US","Voluntary: Firm Initiated","Telephone","TN; SC; NC; NY","B-1644-13","Class II","Red Blood Cells Leukocytes Reduced","W121613100889; W121612226398; W121612204049; W121612175707; W121612141358; ",".","5 units","Blood products, collected from a donor whose suitability to donate was not adequately determined, were distributed.",3/8/2013,"03/08/2013",7/10/2013,"07/10/2013"
"Biologics",64873,"Completed","Arc Blood Services, New England Region","Dedham","MA","US","Voluntary: Firm Initiated","Telephone","Tennessee; New Hampshire; Vermont; Massachusetts; Maryland; Maine; New York","B-1840-13","Class II","Red Blood Cells Leukocytes Reduced","004FM18651; 004FM18653; 004FW12875; 004FW12880; 004FW12920P1; 004FW12920P2; 004FW13213; 004GH23026; 004GH24503; 004GH25651; 004GH26351; 004GH26455; 004GH26464; 004GH26469; 004GH26474; 004GQ14814; 004GQ14822; 004KF92568; 004LH16537; 004LH18502; 004LH18814; 004LH19273; 004LH19285; 004LN29942; 004LN29944; 004LS40757",".","26 units","Blood products, collected from an ineligible donor, were distributed. ",2/15/2013,"02/15/2013",7/17/2013,"07/17/2013"
"Biologics",64873,"Completed","Arc Blood Services, New England Region","Dedham","MA","US","Voluntary: Firm Initiated","Telephone","Tennessee; New Hampshire; Vermont; Massachusetts; Maryland; Maine; New York","B-1839-13","Class II","Red Blood Cells Leukocytes Reduced Irradiated","004LN27612; 004LS39882",".","2 units","Blood products, collected from an ineligible donor, were distributed. ",2/15/2013,"02/15/2013",7/17/2013,"07/17/2013"
"Devices",64874,"Ongoing","Ortho-Clinical Diagnostics","Rochester","NY","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Worldwide Distribution-USA (nationwide) including the states of AR, AZ, CA, CO, CT, FL, HI, ID, IL, KY, LA, ME, NJ, OK, TN, TX, WA, and WV, and the countries of Colombia, India, Japan, Mexico, Puerto Rico, Republic of Panama, Singapore, Venezuela, England, France, Germany, Italy, and Spain.","Z-1556-2013","Class II","VITROS Chemistry Products-HCY Reagent packaged in a kit carton. Catalog# 6802002. Used to quantitatively measure total homocysteine (HCY) concentration in human serum and plasma. ","Lot # 1529-17-2636, expiration date 12 June 2013",,"478 total (339- Domestic) (139- International)","The firm is recalling the specific lot due to lower than expected results. ",4/1/2013,"04/01/2013",6/26/2013,"06/26/2013"
"Devices",64875,"Ongoing","American Medical Systems, Inc.","Minnetonka","MN","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution -- Nationwide Distribution including the states of AL, AZ, AR, CA, CO, CT, DE, FL, GA, IL, IN, IA, KS, KY LA, ME, MD, MA, MI, MN, MS, MO, MT, NE, NH, NJ, NM, NY,NC, OH, OK, OR, PA, PR, RI, SC, TN, TX, UT, VT, VA, WA and WI., and the countries of AUSTRIA, AUSTRALIA, CANADA, BELGIUM, SWITZERLAND, CZECH REPUBLIC, GERMANY, DENMARK, ESTONIA, SPAIN, FINLAND, FRANCE, GREAT BRITAIN, IRELAND, ITALY, LEBANON, NETHERLANDS, NORWAY, SWEDEN, TURKEY, ARGENTINA, BRAZIL, IVORY COST, COLOMBIA, ECUADOR, INDIA, JAPAN, MEXICO, NEW ZEALAND, PANAMA and VENEZUELA.","Z-1279-2013","Class II","AMS 800 Urinary Control System. The AMS 800 Urinary Control System is used to treat urinary incontinence due to reduced outlet resistance (intrinsic sphincter deficiency) following prostate surgery. The AMS 800 Urinary Control System is an implantable, fluid filled, solid silicone elastomer device used to treat stress urinary incontinence. It is designed to restore the natural process of urinary control. The device simulates normal sphincter function by opening and closing the urethra at the control of the patient. The AMS 800 system consists of three inter connected components: a cuff, a pump, and a pressure-regulating balloon. The three components are connected with kink-resistant tubing. The AMS 800 can be implanted at either the bulbous urethra or the bladder neck. ","Model # Lot # 720172-01 737875001 720172-01 737875002 720172-01 737875003 720172-01 737875004 72400098 714613001 72400098 714613002 72400098 714613003 72400098 714613004 72400098 714613005 72400098 714613006 72400098 714613007 72400098 714613008 72400098 714613009 72400098 714613010 72400098 714613011 72400098 714613013 72400098 714613014 72400098 714613015 72400098 714631001 72400098 714631002 72400098 714631003 72400098 714631004 72400098 714631005 72400098 714631006 72400098 714631007 72400098 714631008 72400098 714631009 72400098 714631010 72404127 786981017 72400098 714631014 72400098 714631015 72400098 714631016 72400098 714631017 72400098 714631018 72400098 714631019 72400098 714631020 72400098 714644001 72400098 714644002 72400098 714644003 72400098 714644004 72400098 714644005 72400098 714644007 72400098 714644008 72400098 714644009 72400098 714644010 72400098 714644011 72400098 714644012 72400098 714644013 72400098 714644014 72400098 714644015 72400098 714644016 72400098 714644017 72400098 714660001 72400098 714660002 72400098 714660003 72400098 714660004 72400098 714660005 72400098 714660007 72400098 714660008 72400098 714660010 72400098 714660012 72400098 714660013 72400098 714660016 72400098 714660017 72400098 714660018 72400098 714660019 72400098 716228001 72400098 716228002 72400098 716228003 72400098 716228004 72400098 716228005 72400098 716228006 72400098 716228007 72400098 716228008 72400098 716228009 72400098 716228010 72400098 716228011 72400098 716228012 72400098 716228013 72400098 716228014 72400098 716228015 72400098 716228016 72400098 716228017 72400098 717297001 72400098 717297002 72400098 717297003 72400098 717297004 72400098 717297005 72400098 717297006 72400098 717297007 72400098 717297008 72400098 717297009 72400098 717297010 72400098 717297011 72400098 717297012 72400098 717297013 72400098 717297014 72400098 717297015 72400098 717297016 72400098 717297017 72400098 717297018 72400098 717297019 72400098 719372001 72400098 719372002 72400098 719372003 72400098 719372004 72400098 7193",,"605","American Medical Systems, Inc. is initiating a recall on two components of the AMS 800 Urinary Control System, Control Pump & Pressure-Regulating Balloon. These products were released despite not meeting all final product release criteria.",3/1/2013,"03/01/2013",5/22/2013,"05/22/2013"
"Devices",64875,"Ongoing","American Medical Systems, Inc.","Minnetonka","MN","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution -- Nationwide Distribution including the states of AL, AZ, AR, CA, CO, CT, DE, FL, GA, IL, IN, IA, KS, KY LA, ME, MD, MA, MI, MN, MS, MO, MT, NE, NH, NJ, NM, NY,NC, OH, OK, OR, PA, PR, RI, SC, TN, TX, UT, VT, VA, WA and WI., and the countries of AUSTRIA, AUSTRALIA, CANADA, BELGIUM, SWITZERLAND, CZECH REPUBLIC, GERMANY, DENMARK, ESTONIA, SPAIN, FINLAND, FRANCE, GREAT BRITAIN, IRELAND, ITALY, LEBANON, NETHERLANDS, NORWAY, SWEDEN, TURKEY, ARGENTINA, BRAZIL, IVORY COST, COLOMBIA, ECUADOR, INDIA, JAPAN, MEXICO, NEW ZEALAND, PANAMA and VENEZUELA.","Z-1280-2013","Class II","AMS 800 Urinary Control System. The AMS 800 Urinary Control System is used to treat urinary incontinence due to reduced outlet resistance (intrinsic sphincter deficiency) following prostate surgery. The AMS 800 Urinary Control System is an implantable, fluid filled, solid silicone elastomer device used to treat stress urinary incontinence. It is designed to restore the natural process of urinary control. The device simulates normal sphincter function by opening and closing the urethra at the control of the patient. The AMS 800 system consists of three inter connected components: a cuff, a pump, and a pressure-regulating balloon. The three components are connected with kink-resistant tubing. The AMS 800 can be implanted at either the bulbous urethra or the bladder neck. ","Model # Lot # 72400024 771029003 72400024 794405011 72400024 744211005 72400024 794405007 72400024 744211008 72400024 771029001 72400024 794405006 72400024 771029005 72400024 744211009 72400024 771029016 72400023 741419006 72400024 794405001 72400024 794405002 72400024 794405004 72400024 794405005 72400024 794405015 72400024 794405016 72400024 744211001 72400024 744211004 72400024 800345007 72400024 800345014 72400024 771029012 72400024 794405009 72400024 794405012 72400024 794405013 72400024 794405014 72400023 741419004 72400023 741419005 72400023 741419007 72400023 741419009 72400023 741419010 72400024 744211002 72400024 744211003 72400024 744211006 72400024 744211007 72400024 744211010 72400024 744211011 72400024 771029002 72400024 771029004 72400024 771029006 72400024 771029007 72400024 771029008 72400024 771029009 72400024 771029010 72400024 771029011 72400025 803589003 72400024 771029014 72400024 771029015 72400025 803589005 72400024 794405003 72400024 771029013 72400024 794405008 72400024 800345008 72400024 794405010 72400024 800345001 72400024 800345003 72400024 800345004 72400024 800345005 72400024 800345006 72400024 800345009 72400024 800345010 72400024 800345012 72400024 800345015 72400024 800345002 ",,"77","American Medical Systems, Inc. is initiating a recall on two components of the AMS 800 Urinary Control System, Control Pump & Pressure-Regulating Balloon. These products were released despite not meeting all final product release criteria.",3/1/2013,"03/01/2013",5/22/2013,"05/22/2013"
"Devices",64876,"Ongoing","Abbott Diabetes Care, Inc.","Alameda","CA","US","Voluntary: Firm Initiated","Press Release","Nationwide Distribution","Z-1245-2013","Class I","FreeStyle InsuLinx Blood Glucose Monitoring System: For In Vitro Diagnostic Use only. Use only with FreeStyle InsuLinx test strips. Abbott Diabetes Care, Inc. 1360 South Loop Road Alameda, CA 94502 USA The FreeStyle InsuLinx Blood Glucose Test Strips are for use with the FreeStyle InsuLinx Blood Glucose Meter to quantitatively measure glucose in capillary whole blood samples drawn from the fingertip. ","Part Numbers: 71142-70 71143-70 71145-70 71150-70: All serial and lot numbers.",".","335,273 meters in the US, and 607,137 internationally ","AT rare, extremely high glucose levels (1024 mg/dL and above), the FreeStyle InsuLinx Blood Glucose Meter may provide an inaccurate reading.",4/15/2013,"04/15/2013",5/15/2013,"05/15/2013"
"Food",64877,"Ongoing","La Espanola Meats Inc","Harbor City","CA","US","Voluntary: Firm Initiated","Other","Sold through recalling firm's owned retail market in California.","F-1341-2013","Class II","Cabrales Rojo Prieto Cheese, 1.9 kg or 4.1 lbs each wheel. 2 units per carton.","Lot Number 113 Best By 11/11/2013",".","approximately 106 lbs","In response to a FDA inspection, the firm initiated the recall because the product was found to be contaminated with Staphylococcus Aureus, E. Coli, and Alkaline Phosphatase.",4/9/2013,"04/09/2013",5/1/2013,"05/01/2013"
"Drugs",64878,"Ongoing","Affirm XL, Inc.","Ladera Ranch","CA","US","Voluntary: Firm Initiated","Press Release","Nationwide in the US and Canada","D-015-2014","Class I","Affirm XL Nutritional Supplement, 1 and 10 count blister packs and single pill packs, Manufactured by Dongseo Biopharm Corp., Yongin City, Kyonggi do, Korea, distributed by: Affirm XL, LLC, Ladera Ranch, CA","Lot# 1190001, exp 12/30/2013",,"400 pills","Marketed Without An Approved NDA/ANDA: FDA analysis found the product to contain sulfoaildenafil, an analogue of sildenafil which is an ingredient in an FDA-approved drug for the treatment of male erectile dysfunction, making this an unapproved new drug.",4/10/2013,"04/10/2013",11/27/2013,"11/27/2013"
"Drugs",64879,"Ongoing","FVS Holdings, Inc. dba. Green Valley Drugs","Henderson","NV","US","Voluntary: Firm Initiated","Press Release","Nationwide","D-339-2013","Class II","Acetylcysteine Injection, all strengths and all presentations including 100 mg/mL in 30 mL vials and 200 mg/mL in 30 mL and 50 mL vials, Rx only, Green Valley Drugs, 1850 Whitney Mesa, #180, Henderson, NV 89014.","Lot #: 20130129-J, 20130129-L, Exp 04/29/13; 20130405-H, Exp 07/05/13.",,"93 vials","Lack of Assurance of Sterility: all sterile products compounded, repackaged, and distributed by this compounding pharmacy due to lack of sterility assurance and concerns associated with the quality control processes.",4/10/2013,"04/10/2013",5/22/2013,"05/22/2013"
"Drugs",64879,"Ongoing","FVS Holdings, Inc. dba. Green Valley Drugs","Henderson","NV","US","Voluntary: Firm Initiated","Press Release","Nationwide","D-371-2013","Class II","Hyaluronidase Injection, all strengths and all presentations including a) Hyaluronidase 150u/mL, b) Hyaluronidase 150u/ml 1 mL PF, c) Hyaluronidase 150u/mL PF 1ml SDV, Rx only, Green Valley Drugs, 1850 Whitney Mesa, #180, Henderson, NV 89014.","Lot #: a) Hyaluronidaise 150u/mL: 20130205-G, Exp 5/5/2013; b) Hyaluronidase 150u/mL 1 mL PF: 20130321-A, Exp 6/21/2013; c) Hyaluronidase 150u/mL PF 1ml SDV: 20130313-E, Exp 6/13/2013. .",,"996 vials","Lack of Assurance of Sterility: all sterile products compounded, repackaged, and distributed by this compounding pharmacy due to lack of sterility assurance and concerns associated with the quality control processes.",4/10/2013,"04/10/2013",5/22/2013,"05/22/2013"
"Drugs",64879,"Ongoing","FVS Holdings, Inc. dba. Green Valley Drugs","Henderson","NV","US","Voluntary: Firm Initiated","Press Release","Nationwide","D-350-2013","Class II","Biotin Injection, all strengths and all presentations including Biotin-15-30 mL, Rx only, Green Valley Drugs, 1850 Whitney Mesa, #180, Henderson, NV 89014.","Lot #: 130117500AE, Exp 4/17/2013",,"7 vials","Lack of Assurance of Sterility: all sterile products compounded, repackaged, and distributed by this compounding pharmacy due to lack of sterility assurance and concerns associated with the quality control processes.",4/10/2013,"04/10/2013",5/22/2013,"05/22/2013"
"Drugs",64879,"Ongoing","FVS Holdings, Inc. dba. Green Valley Drugs","Henderson","NV","US","Voluntary: Firm Initiated","Press Release","Nationwide","D-403-2013","Class II","Pyridoxine Hydrochloride Injection, all strengths and all presentations including Pyridoxine 100 mg/mL 30 mL, 50 mL, and 10 mL PF SDV, Rx only, Green Valley Drugs, 1850 Whitney Mesa, #180, Henderson, NV 89014.","Lot #: 20130130-J, Exp 4/30/2013; 20130225-D, Exp 5/25/2013; 20130315-I, Exp 6/15/2013 ",,"319 vials","Lack of Assurance of Sterility: all sterile products compounded, repackaged, and distributed by this compounding pharmacy due to lack of sterility assurance and concerns associated with the quality control processes.",4/10/2013,"04/10/2013",5/22/2013,"05/22/2013"
"Drugs",64879,"Ongoing","FVS Holdings, Inc. dba. Green Valley Drugs","Henderson","NV","US","Voluntary: Firm Initiated","Press Release","Nationwide","D-388-2013","Class II","Methylprednisolone Acetate and Marcaine Injection, all strengths and all presentations including a) Methylpred 80 mg/mL and Marcaine 0.25%-2.75, b) Methylpred_Marc-0.25-0.27, Rx only, Green Valley Drugs, 1850 Whitney Mesa, #180, Henderson, NV 89014.","Lot#: a) Methylpred 80 mg/mL and Marcaine 0.25%-2.75: 130312200GV3, Exp 6/12/13; b) Methylpred_Marc-0.25-0.27: 13011536, Exp 4/15/2013; 20130226-GV2, Exp 5/26/2013; 13012335GV4, Exp 4/23/2013; 13012460GV2, Exp 4/24/2013",,"607 vials","Lack of Assurance of Sterility: all sterile products compounded, repackaged, and distributed by this compounding pharmacy due to lack of sterility assurance and concerns associated with the quality control processes.",4/10/2013,"04/10/2013",5/22/2013,"05/22/2013"
"Drugs",64879,"Ongoing","FVS Holdings, Inc. dba. Green Valley Drugs","Henderson","NV","US","Voluntary: Firm Initiated","Press Release","Nationwide","D-416-2013","Class II","Zinc Sulfate Injection, all strengths and all presentations including a) Zinc Sulfate 10 mg/mL 30 mL and b) Zinc Sulfate 1 mg/mL 10 mL, Rx only, Green Valley Drugs, 1850 Whitney Mesa, #180, Henderson, NV 89014.","Lot #: a) Zinc Sulfate 10 mg/30 mL: 20130404-A, Exp 7/4/2013; b) Zinc Sulfate 1 mg/10 mL: 20130206-B, Exp 5/6/2013 . ",,"208 vials","Lack of Assurance of Sterility: all sterile products compounded, repackaged, and distributed by this compounding pharmacy due to lack of sterility assurance and concerns associated with the quality control processes.",4/10/2013,"04/10/2013",5/22/2013,"05/22/2013"
"Drugs",64879,"Ongoing","FVS Holdings, Inc. dba. Green Valley Drugs","Henderson","NV","US","Voluntary: Firm Initiated","Press Release","Nationwide","D-356-2013","Class II","Cyclosporine Injection, all strengths and all presentations including Cyclosporine 2% Aqueous Solution 15 mL, Rx only, Green Valley Drugs, 1850 Whitney Mesa, #180, Henderson, NV 89014.","Lot #: 20130122-F, Exp 4/22/2013",,"1 vial","Lack of Assurance of Sterility: all sterile products compounded, repackaged, and distributed by this compounding pharmacy due to lack of sterility assurance and concerns associated with the quality control processes.",4/10/2013,"04/10/2013",5/22/2013,"05/22/2013"
"Drugs",64879,"Ongoing","FVS Holdings, Inc. dba. Green Valley Drugs","Henderson","NV","US","Voluntary: Firm Initiated","Press Release","Nationwide","D-405-2013","Class II","Sodium Bicarbonate and Lidocaine Injection, all strengths and all presentations including Sod-Bicarb-Lido-0.27-2.73-3 syr, Rx only, Green Valley Drugs, 1850 Whitney Mesa, #180, Henderson, NV 89014.","Lot #: 20130226-GV4, Exp 5/26/2013; 13031150GV3, Exp 6/11/2013; 13031240GV4, Exp 6/12/2013; 13012325GV5, Exp 4/23/2013; 13021820GV3, Exp 5/18/2013; 13011520, Exp 4/15/2013; 13012425GV1, Exp 4/24/2013",,"335 vials","Lack of Assurance of Sterility: all sterile products compounded, repackaged, and distributed by this compounding pharmacy due to lack of sterility assurance and concerns associated with the quality control processes.",4/10/2013,"04/10/2013",5/22/2013,"05/22/2013"
"Drugs",64879,"Ongoing","FVS Holdings, Inc. dba. Green Valley Drugs","Henderson","NV","US","Voluntary: Firm Initiated","Press Release","Nationwide","D-358-2013","Class II","Dexpanthenol Injection, all strengths and all presentations including Dexpanthenol 250 mg/30 mL; Dexpanthenol 250 mg/mL 10 mL, 30 mL, 50 mL; and Dexpanthenol 250 mg/mL 10 mL P.F.; Rx only, Green Valley Drugs, 1850 Whitney Mesa, #180, Henderson, NV 89014.","Lot #: 20130212-A, Exp 5/12/2013; 20130122-E, Exp 4/22/2013; 20130212-D, Exp 5/12/2013 ",,"273 vials","Lack of Assurance of Sterility: all sterile products compounded, repackaged, and distributed by this compounding pharmacy due to lack of sterility assurance and concerns associated with the quality control processes.",4/10/2013,"04/10/2013",5/22/2013,"05/22/2013"
"Drugs",64879,"Ongoing","FVS Holdings, Inc. dba. Green Valley Drugs","Henderson","NV","US","Voluntary: Firm Initiated","Press Release","Nationwide","D-395-2013","Class II","MIC Vitamin Injection, all strengths and all presentations including a) MIC 25-50-25-30 mL, b) MIC_B_COMP-B12-25-50-50-1000-30 mL, c) MIC_B12-25-50-25-400-30 mL, d) MIC_B6_B12-30 mL, e) MIC_METH_VIT-#3-30 m, f) MIC_METH-25-50-50-1000 mcg 30 mL, g) MIC_ULTRA-30 mL, h) MIC_VIT_METH_CARN-12.5-25-25-1-25-30 mL, i) MIC-25-50-25 Cyano 1000 mcg/mL 30 mL, j) MIC-25-50-50-30 mL, k) MIC-8-15-15-30, l) MIC-B12-30, Rx only, Green Valley Drugs, 1850 Whitney Mesa, #180, Henderson, NV 89014.","Lot #: a) MIC 25-50-25-30 mL: 20130130-D, Exp 4/30/2013; 20130214-F, Exp 5/14/2013; b) MIC_B_COMP-B12-25-50-50-1000-30 mL: 1303261000AE, Exp 6/26/2013; c) MIC_B12-25-50-25-400-30 mL: 20130307-I, Exp 6/7/2013; 20120206-H, Exp 5/6/2013; d) MIC_B6_B12-30 mL: 20130208-E, Exp 5/8/2013; e) MIC_METH_VIT-#3-30 mL: 1302072000AE, Exp 5/7/2013; f) MIC_METH-25-50-50-1000 mcg 30 mL: 20130326-G, Exp 6/26/2013; g) MIC_ULTRA-30 mL: 20130220-I, Exp 5/20/2013; h) MIC_VIT_METH_CARN-12.5-25-25-1-25-30 mL: 1302081000AE, Exp 5/8/2013; 20130327-C, Exp 6/27/2013; i) MIC-25-50-25 Cyano 1000 mcg/mL 30mL: 1303261000AE, Exp 6/26/2013; j) MIC-25-50-50-30 mL; 20130213-E, Exp 5/13/2013; k) MIC-8-15-15-30: 20130118-C, Exp 4/18/2013; 20130318-F, Exp 6/18/2013; l) MIC-B12-30: 20130114-C, Exp 4/14/2013",,"588 vials and syringes","Lack of Assurance of Sterility: all sterile products compounded, repackaged, and distributed by this compounding pharmacy due to lack of sterility assurance and concerns associated with the quality control processes.",4/10/2013,"04/10/2013",5/22/2013,"05/22/2013"
"Drugs",64879,"Ongoing","FVS Holdings, Inc. dba. Green Valley Drugs","Henderson","NV","US","Voluntary: Firm Initiated","Press Release","Nationwide","D-408-2013","Class II","Sodium Chloride Injection, all strengths and all presentations including a) Bacteriostatic Sodium Chloride 0.9% 30 mL, b) Sodium Chloride 23.4% 30 mL PF, and c) Sodium Chloride 23.4% 50 mL, Rx only, Green Valley Drugs, 1850 Whitney Mesa, #180, Henderson, NV 89014.","Lot #: a) Bacteriostatic Sodium Chloride 0.9% 30 mL, 20121205, Exp 6/11/2013; b) Sodium Chloride 23.4% 30 mL PF: 20130115-G, Exp 4/15/2013; c) Sodium Chloride 23.4% 50 mL: 20130114-E, Exp 4/14/2013",,"318 vials","Lack of Assurance of Sterility: all sterile products compounded, repackaged, and distributed by this compounding pharmacy due to lack of sterility assurance and concerns associated with the quality control processes.",4/10/2013,"04/10/2013",5/22/2013,"05/22/2013"
"Drugs",64879,"Ongoing","FVS Holdings, Inc. dba. Green Valley Drugs","Henderson","NV","US","Voluntary: Firm Initiated","Press Release","Nationwide","D-342-2013","Class II","Ascorbic Acid Injection, all strengths and all presentations including a) 500 mg/mL, b) corn source 500 mg/mL, c) tapioca 500 mg/mL, d) cassave 500; Rx only, Green Valley Drugs, 1850 Whitney Mesa, #180, Henderson, NV 89014.","Lot #: a) 20130313-M, Exp 6/13/2013; 20130306-N, Exp 6/6/2013; 20130220-E, Exp 5/20/2013; 20130222-D, Exp 5/22/2013; 20130205-B, Exp 5/5/2013; 20130205-C, Exp 5/5/2013; 20130222-F, Exp 5/22/2013; 20130315-H, Exp 6/15/2013; 20130313-L, Exp 6/16/2013; 20130306-O, Exp 6/6/2013; 20130328-A, Exp 6/28/2013; 20130404-F, Exp 7/4/2013; 20130333-B, Exp 6/30/2013; 20130301-D, Exp 6/1/2013; 20130311-H, Exp 6/11/2013; 20130328-A, Exp 6/28/2013; 20130404-D, Exp 7/4/2013; 20130404-E, Exp 7/4/2013; 20130315-G, Exp 6/15/2013; 20130322-G, Exp 6/22/2013; 20130228-D, Exp 5/28/2013; 20130205-B, Exp 5/5/2013; b) 20130315-G, Exp 6/15/2013; 20130322-G, Exp 6/22/2013; c) 1302121000AE, Exp 5/12/2013; 20130322-C, Exp 6/22/2013; 20130401-C, Exp 7/1/2013; 20130131-D, Exp 4/30/2013; 20130213-A, Exp 5/13/2013; 20130305-G, Exp 6/5/2013; 20130131-B, Exp 4/30/2013; 20130201-D, Exp 5/1/2013; 2013201-G, Exp 5/1/2013; 20130222-E, Exp 5/22/2013; 20130322-B, Exp 6/22/2013; 20130131-C, Exp 4/30/2013; 20130131-E, Exp 4/30/2013; 20130213-A, 5/13/2013; 20130201-A, Exp 5/2/2013; 20130221-T, Exp 5/21/2013; 20130311-D, Exp 6/11/2013; 20130311-C, Exp 6/11/2013; 20130311-B, Exp 6/11/2013; 20130314-A, Exp 6/14/2013; 20130314-B, Exp 6/14/2013; 20130315-D, Exp 6/15/2013; 20130304-A, Exp 6/4/2013; 20130318-L, Exp 6/18/2013; 20130325-B, Exp 6/25/2013; 20130318-M, Exp 6/18/2013; d) 20130128-C, Exp 4/28/2013; 20130124J, Exp 4/24/2013; 20130403-C, Exp 7/3/2013; 20130124-J, Exp 4/24/2013, 20130115-I, Exp 4/15/2013.",,"2682 vials","Lack of Assurance of Sterility: all sterile products compounded, repackaged, and distributed by this compounding pharmacy due to lack of sterility assurance and concerns associated with the quality control processes.",4/10/2013,"04/10/2013",5/22/2013,"05/22/2013"
"Drugs",64879,"Ongoing","FVS Holdings, Inc. dba. Green Valley Drugs","Henderson","NV","US","Voluntary: Firm Initiated","Press Release","Nationwide","D-394-2013","Class II","Metoprolol Injection, all strengths and all presentations including Metoprolol 1 mg/mL 5 mL, Rx only, Green Valley Drugs, 1850 Whitney Mesa, #180, Henderson, NV 89014.","Lot #: 20130130-B, Exp 4/30/2013 ",,"65 vials","Lack of Assurance of Sterility: all sterile products compounded, repackaged, and distributed by this compounding pharmacy due to lack of sterility assurance and concerns associated with the quality control processes.",4/10/2013,"04/10/2013",5/22/2013,"05/22/2013"
"Drugs",64879,"Ongoing","FVS Holdings, Inc. dba. Green Valley Drugs","Henderson","NV","US","Voluntary: Firm Initiated","Press Release","Nationwide","D-340-2013","Class II","Alpha Lipoic Acid Injection, all strengths and all presentations including 25 mg/mL, 30 mL, Rx only, Green Valley Drugs, 1850 Whitney Mesa, #180, Henderson, NV 89014.","Lot #: 20130319-C, Exp 06/19/13; 20130329-C, Exp 06/29/13 ",,"78 vials","Lack of Assurance of Sterility: all sterile products compounded, repackaged, and distributed by this compounding pharmacy due to lack of sterility assurance and concerns associated with the quality control processes.",4/10/2013,"04/10/2013",5/22/2013,"05/22/2013"
"Drugs",64879,"Ongoing","FVS Holdings, Inc. dba. Green Valley Drugs","Henderson","NV","US","Voluntary: Firm Initiated","Press Release","Nationwide","D-377-2013","Class II","L-Carnitine Injection, all strengths and all presentations including L-Carnitine 500 mg/mL 30 mL, Rx only, Green Valley Drugs, 1850 Whitney Mesa, #180, Henderson, NV 89014.","Lot #: 20130402-G, Exp 7/2/2013; 20130129-H, Exp 4/29/2013 ",,"65 vials","Lack of Assurance of Sterility: all sterile products compounded, repackaged, and distributed by this compounding pharmacy due to lack of sterility assurance and concerns associated with the quality control processes.",4/10/2013,"04/10/2013",5/22/2013,"05/22/2013"
"Drugs",64879,"Ongoing","FVS Holdings, Inc. dba. Green Valley Drugs","Henderson","NV","US","Voluntary: Firm Initiated","Press Release","Nationwide","D-343-2013","Class II","Betamethasone Acetate and Betamethasone Sodium Injection, all strengths and all presentations including 6 mg/mL preservative free, 2 ml; 106 mg/mL 10 mL, and 6 mg/mL 5 mL, Rx only, Green Valley Drugs, 1850 Whitney Mesa, #180, Henderson, NV 89014.","Lot #: 20130114-A, Exp 4/14/2013; 20130123-B, Exp 4/23/2013; 20130124-A, Exp 4/24/2013; 20130212-A, Exp 5/12/2013; 20130321-B, Exp 6/21/2013; 20130319-M, Exp 6/19/2013",,"4368 vials","Lack of Assurance of Sterility: all sterile products compounded, repackaged, and distributed by this compounding pharmacy due to lack of sterility assurance and concerns associated with the quality control processes.",4/10/2013,"04/10/2013",5/22/2013,"05/22/2013"
"Drugs",64879,"Ongoing","FVS Holdings, Inc. dba. Green Valley Drugs","Henderson","NV","US","Voluntary: Firm Initiated","Press Release","Nationwide","D-383-2013","Class II","Magnesium Chloride Injection, all strengths and all presentations including a) Magnesium Chloride 200 mg/50 mL and b) Magnesium Chloride 200 mg/mL 50 mL, Rx only, Green Valley Drugs, 1850 Whitney Mesa, #180, Henderson, NV 89014.","Lot #: a) Magnesium Chloride 200 mg/50 mL: 20130321-F, Exp 6/21/2013; 20130319-I, Exp 6/19/2013; b) Magnesium Chloride 200 mg/mL 50mL: 20130307-F, Exp 6/7/2013 ",,"197 vials","Lack of Assurance of Sterility: all sterile products compounded, repackaged, and distributed by this compounding pharmacy due to lack of sterility assurance and concerns associated with the quality control processes.",4/10/2013,"04/10/2013",5/22/2013,"05/22/2013"
"Drugs",64879,"Ongoing","FVS Holdings, Inc. dba. Green Valley Drugs","Henderson","NV","US","Voluntary: Firm Initiated","Press Release","Nationwide","D-414-2013","Class II","Thiamine Hydrochloride Injection, all strengths and all presentations including a) Thiamine 100 mg/30 mL, b) Thiamine Hydrochloride 100 mg/mL with preservative 30 mL, c) Thiamine Hydrochloride 50 mg/mL with preservative 30 mL, d) Thiamine Hydrochloride 100 mg/mL preservative free 10 mL and 30 mL, Rx only, Green Valley Drugs, 1850 Whitney Mesa, #180, Henderson, NV 89014.","Lot #: a) Thiamine 100 mg/30 mL: 20130130-G, Exp 4/30/2013",,"70 vials","Lack of Assurance of Sterility: all sterile products compounded, repackaged, and distributed by this compounding pharmacy due to lack of sterility assurance and concerns associated with the quality control processes.",4/10/2013,"04/10/2013",5/22/2013,"05/22/2013"
"Drugs",64879,"Ongoing","FVS Holdings, Inc. dba. Green Valley Drugs","Henderson","NV","US","Voluntary: Firm Initiated","Press Release","Nationwide","D-344-2013","Class II","Bacteriostatic Water for Injection, all presentations including 30 mL, Rx only, Green Valley Drugs, 1850 Whitney Mesa, #180, Henderson, NV 89014.","Lot #: 20130122-C, Exp 4/22/2013; 20130122-D, Exp 4/22/2013; 20130319-A, Exp 6/19/2013 ",,"597 vials","Lack of Assurance of Sterility: all sterile products compounded, repackaged, and distributed by this compounding pharmacy due to lack of sterility assurance and concerns associated with the quality control processes.",4/10/2013,"04/10/2013",5/22/2013,"05/22/2013"
"Drugs",64879,"Ongoing","FVS Holdings, Inc. dba. Green Valley Drugs","Henderson","NV","US","Voluntary: Firm Initiated","Press Release","Nationwide","D-349-2013","Class II","Betamethasone Combination with Lidocaine 1% and Bupivacaine 0.5 % Injection, all strengths and all presentations including a) Betameth combo 6 mg/mL lido 1% bup 0.5% syr; and b) Betameth Combo/Lidocaine 1%/ Bupivacaine 0.5% Syr, Rx only, Green Valley Drugs, 1850 Whitney Mesa, #180, Henderson, NV 89014.","Lot #: a) Betameth combo 6mg/ml lido1% bup 0.5% syr: 13021975, Exp 5/19/2013; b) Betameth Combo/Lidocaine 1%/ Bupivacaine 0.5% Syr: 13012550, Exp 4/25/2013; 130215100, Exp 5/15/2013",,"270 syringes","Lack of Assurance of Sterility: all sterile products compounded, repackaged, and distributed by this compounding pharmacy due to lack of sterility assurance and concerns associated with the quality control processes.",4/10/2013,"04/10/2013",5/22/2013,"05/22/2013"
"Drugs",64879,"Ongoing","FVS Holdings, Inc. dba. Green Valley Drugs","Henderson","NV","US","Voluntary: Firm Initiated","Press Release","Nationwide","D-393-2013","Class II","Methylprednisolone Acetate Injection, all strengths and all presentations including a) Methylprednisolone Acetate 40 mg/mL, b) Methylprednisolone Acetate (PF) 40 mg/mL, c) Methylprednisolone Acetate (PF) 80 mg/mL, d) Methylpred Acetate 40 mg/mL 1 mL, e) Methylprednisolone 80 mg/5 mL; Rx only, Green Valley Drugs, 1850 Whitney Mesa, #180, Henderson, NV 89014.","a) Methylprednisolone Acetate 40 mg/mL: 20130228-E, Exp 5/28/2013; 2013012370-GV3, Exp 4/23/2013; 20130318-D, Exp 6/18/2013; b) Methylprednisolone Acetate (PF) 40 mg/mL: 20130219-B, Exp 5/19/2013; 20130315-B, Exp 6/15/2013; c) Methylprednisolone Acetate (PF) 80 mg/mL: 201303131-A, Exp 6/13/2013; 20130304-M, Exp 6/4/2013; 20130405-A, Exp 7/5/2013; 20130214-G, Exp 5/14/2013; d) Methylpred Acetate 40 mg/mL 1 mL: 20130318-D, Exp 6/18/2013; e) Methylprednisolone 80 mg/5 mL: 20130214-G, Exp 5/14/2013 ",,"4350 vials and syringes","Lack of Assurance of Sterility: all sterile products compounded, repackaged, and distributed by this compounding pharmacy due to lack of sterility assurance and concerns associated with the quality control processes.",4/10/2013,"04/10/2013",5/22/2013,"05/22/2013"
"Drugs",64879,"Ongoing","FVS Holdings, Inc. dba. Green Valley Drugs","Henderson","NV","US","Voluntary: Firm Initiated","Press Release","Nationwide","D-400-2013","Class II","Polidocanol Injection, all strengths and all presentations including a) Polidocanol 5% 30 mL, b) Polidocanol 1% 30 mL, c) Polidocanol 2% 30 mL, d) Polidocanol 3% 30 mL, Rx only, Green Valley Drugs, 1850 Whitney Mesa, #180, Henderson, NV 89014.","Lot #: Polidocanol 5% 30 mL: 20130319-I, Exp 6/19/2013; 20130326-H, Exp 6/26/2013; b) Polidocanol 1% 30 mL: 20130118-B, Exp 4/18/2013 ",,"109 vials","Lack of Assurance of Sterility: all sterile products compounded, repackaged, and distributed by this compounding pharmacy due to lack of sterility assurance and concerns associated with the quality control processes.",4/10/2013,"04/10/2013",5/22/2013,"05/22/2013"
"Drugs",64879,"Ongoing","FVS Holdings, Inc. dba. Green Valley Drugs","Henderson","NV","US","Voluntary: Firm Initiated","Press Release","Nationwide","D-351-2013","Class II","Bupivacaine and Dexamethasone Injection, all strengths and all presentations including Bupiv_Dexameth-0.25-10.5; Rx only, Green Valley Drugs, 1850 Whitney Mesa, #180, Henderson, NV 89014.","Lot #: 13011450GV4, 13011450GV1, Exp 4/14/2013; 13011760B, Exp 4/17/2013; 13012450, Exp 4/24/2013; 13021960GV2, Exp 5/19/2013; 2013021950GV2, Exp 5/19/2013; 20130222GV3, Exp 5/22/2013; 13020450GV3, Exp 5/4/2013; 13020850GV2, Exp 5/8/2013; 13031330GV2, Exp 6/13/2013; 13032730GV1, Exp 6/27/2013; 20130327GV2, Exp 6/27/2013; 1303031475GV2, Exp 6/3/2013; 130301100GV2, Exp 6/1/2013 ",,"1150 vials","Lack of Assurance of Sterility: all sterile products compounded, repackaged, and distributed by this compounding pharmacy due to lack of sterility assurance and concerns associated with the quality control processes.",4/10/2013,"04/10/2013",5/22/2013,"05/22/2013"
"Drugs",64879,"Ongoing","FVS Holdings, Inc. dba. Green Valley Drugs","Henderson","NV","US","Voluntary: Firm Initiated","Press Release","Nationwide","D-369-2013","Class II","Glycerin/Lidocaine/Epinephrine Injection including Glycerin 72% Lido:Epi 2-1-30 mL, Rx only, Green Valley Drugs, 1850 Whitney Mesa, #180, Henderson, NV 89014.","Lot #: 20130211-U, Exp 5/11/2013",,"unknown","Lack of Assurance of Sterility: all sterile products compounded, repackaged, and distributed by this compounding pharmacy due to lack of sterility assurance and concerns associated with the quality control processes.",4/10/2013,"04/10/2013",5/22/2013,"05/22/2013"
"Drugs",64879,"Ongoing","FVS Holdings, Inc. dba. Green Valley Drugs","Henderson","NV","US","Voluntary: Firm Initiated","Press Release","Nationwide","D-396-2013","Class II","Modified Myers Cocktail Injection, all strengths and all presentations including a) Mod Meyer's Cocktail 37 mL and b) Modified Myers Cocktail 37 mL, Rx only, Green Valley Drugs, 1850 Whitney Mesa, #180, Henderson, NV 89014.","Lot #: a) 20130321-E, Exp 6/21/2013; b) 20130215-F, Exp 5/15/2013 ",,"70 vials","Lack of Assurance of Sterility: all sterile products compounded, repackaged, and distributed by this compounding pharmacy due to lack of sterility assurance and concerns associated with the quality control processes.",4/10/2013,"04/10/2013",5/22/2013,"05/22/2013"
"Drugs",64879,"Ongoing","FVS Holdings, Inc. dba. Green Valley Drugs","Henderson","NV","US","Voluntary: Firm Initiated","Press Release","Nationwide","D-361-2013","Class II","Edetate Disodium Injection, all strengths and all presentations including a) Edetate Disodium 150/30 mL and b) Edetate Disodium 150/100 mL, Rx only, Green Valley Drugs, 1850 Whitney Mesa, #180, Henderson, NV 89014.","Lot #: a) Edetate Disodium_150/30 mL: 20130201-E, Exp 5/2/2013; b) Edetate Disodium_150/100 mL: 20130124-B, 4/24/2013; 20130213-B, Exp 5/13/2013; 20130213-C, Exp 5/13/2013; 20130401-B, Exp 7/1/2013 ",,"98 vials","Lack of Assurance of Sterility: all sterile products compounded, repackaged, and distributed by this compounding pharmacy due to lack of sterility assurance and concerns associated with the quality control processes.",4/10/2013,"04/10/2013",5/22/2013,"05/22/2013"
"Drugs",64879,"Ongoing","FVS Holdings, Inc. dba. Green Valley Drugs","Henderson","NV","US","Voluntary: Firm Initiated","Press Release","Nationwide","D-391-2013","Class II","Methylprednisolone, Lidocaine, and Sodium Chloride Injection, all strengths and all presentations including a) Methylpred-Lido-Nacl-1-5-6-12 syringe and b) Methylpred80mg/lido1%/Sodium Chloride0.9% syr; Rx only, Green Valley Drugs, 1850 Whitney Mesa, #180, Henderson, NV 89014.","Lot #: a) Methylpred-Lido-Nacl-1-5-6-12 syringe: 20120226-GV3, Exp 5/26/2013; 13012370GV3, Exp 4/23/2013; 13012480, Exp 4/24/2013; 13011550, Exp 4/15/2013; b) Methylpred80mg/lido1%/Sodium Chloride0.9% syr: 13012370-GV3, Exp 4/23/2013",,"720 syringes","Lack of Assurance of Sterility: all sterile products compounded, repackaged, and distributed by this compounding pharmacy due to lack of sterility assurance and concerns associated with the quality control processes.",4/10/2013,"04/10/2013",5/22/2013,"05/22/2013"
"Drugs",64879,"Ongoing","FVS Holdings, Inc. dba. Green Valley Drugs","Henderson","NV","US","Voluntary: Firm Initiated","Press Release","Nationwide","D-363-2013","Class II","ED Mix Injections, all strengths and all presentations including a) ED mix TM -at 2, b) ED-Mix BI-Mix 10 30 mL, c) ED-Mix BI-Mix 9 30 mL; d) ED-Mix BI-Mix-3-30, e) ED-Mix PGE 80-30, f) ED-Mix SB4 30 mL, g) Ed-Mix ST 9E, h) ED-Mix ST-1, i) ED-MIX T106, j) ED-MIX-PGE-150 30 mL, k) ED-MIX-PGE-40-30, l) ED-MIX-ST 9A, m) ED-MIX-ST 9D, n) ED-MIX-ST-9B, o) ED-MIX-T 101, p) ED-MIX-T105, Rx only, Green Valley Drugs, 1850 Whitney Mesa, #180, Henderson, NV 89014.","Lot #: a) ED mix TM -at 2: 20130306-M, Exp 6/6/2013; b) ED-Mix BI-Mix 10 30 mL: 130207120AE, Exp 5/7/2013; c) ED-Mix BI-Mix 9 30 mL: 20130121-G, Exp 4/21/2013; 20130301-F, Exp 5/1/2013; d) ED-Mix BI-Mix-3-30: 20130124-H, Exp 4/24/2013; 20130305-J, Exp 6/5/2013; e) ED-Mix PGE 80-30: 1302041000AE, Exp 5/4/2013; 20130313-B, Exp 6/13/2013; 20130322-H, Exp 6/22/2013; 20130405-I, Exp 7/5/2013; f) ED-Mix SB4 30 mL: 130304150AE, Exp 6/4/2013; g) Ed-Mix ST 9E: 2013220-C, Exp 5/20/2013; h) ED-Mix ST-1: 20130313-A, Exp 6/13/2013; 20130322-l, Exp 6/22/2013; 20120220-H, Exp 5/20/2013; 20130208-I, Exp 5/8/2013; i) ED-MIX T106: 20130322-M, Exp 6/22/2013; 20130204-L, Exp 5/4/2013; 20130313-D, Exp 6/13/2013; 20130306-R, Exp 6/6/2013; 20130401-H, Exp 7/1/2013; j) ED-MIX-PGE-150 30 mL: 20130401-J, Exp 7/1/2013; k) ED-MIX-PGE-40-30: 20130307-B, Exp 6/7/2013; 20130322-I, Exp 6/22/2013; l) ED-MIX-ST 9A: 20130401-K, Exp 7/1/2013; m) ED-MIX-ST 9D: 20130401-L, Exp 7/1/2013; n) ED-MIX-ST-9B: 20130327-A, Exp 6/27/2013; o) ED-MIX-T 101: 20130322-J, Exp 6/22/2013; 20130220-D, Exp 5/20/2013; p) ED-MIX-T105: 20130322-K, Exp 6/22/2013; 20130204-K, Exp 5/4/2013; 20130220-F, Exp 5/20/2013; 20130401-I, Exp 7/1/2013 ",,"10684 vials","Lack of Assurance of Sterility: all sterile products compounded, repackaged, and distributed by this compounding pharmacy due to lack of sterility assurance and concerns associated with the quality control processes.",4/10/2013,"04/10/2013",5/22/2013,"05/22/2013"
"Drugs",64879,"Ongoing","FVS Holdings, Inc. dba. Green Valley Drugs","Henderson","NV","US","Voluntary: Firm Initiated","Press Release","Nationwide","D-357-2013","Class II","Dexamethasone Sodium Phosphate Injection, all strengths and all presentations including a) Dexamethasone Sodium Phosphate 10 mg/1 mL, b) Dexamethasone Sodium Phosphate 10 mg/mL PF 1 mL, c) Dexamethasone Sodium Phosphate 4 mg/30 mL, d) Dexamethasone-4 mg/5 mL P.F., Rx only, Green Valley Drugs, 1850 Whitney Mesa, #180, Henderson, NV 89014.","Lot #: a) Dexamethasone Sodium Phosphate 10mg/1ml: 20130402-F, Exp 7/2/2013; b) Dexamethasone Sodium Phosphate 10mg/ml PF 1ml: 20130307-H, Exp 6/7/2013; c) Dexamethasone Sodium Phosphate 4mg/30ml: 20130117-B, Exp 4/17/2013; 20130326-C, Exp 6/26/2013; 20130307-E, Exp 6/7/2013; 20130221-D, Exp 5/21/2013; d) Dexamethasone-4mg/5ml P.F.: 20130328-L, Exp 6/28/2013",,"4399 vials","Lack of Assurance of Sterility: all sterile products compounded, repackaged, and distributed by this compounding pharmacy due to lack of sterility assurance and concerns associated with the quality control processes.",4/10/2013,"04/10/2013",5/22/2013,"05/22/2013"
"Drugs",64879,"Ongoing","FVS Holdings, Inc. dba. Green Valley Drugs","Henderson","NV","US","Voluntary: Firm Initiated","Press Release","Nationwide","D-409-2013","Class II","Sodium Tetradecyl Sulfate Injection, all strengths and all presentations including a) Sodium Tetradecyl Sulfate 3% 50 mL, b) Sodium Tetradecyl Sulfate 3% mL, c) Sodium Tetradecyl Sulfate-2% 30 mL, d) Sodium Tetradecyl Sulfate-2.5% 20 mL, e) Sodium Tetradecyl Sulfate 0.3% 30 mL, f) Sodium Tetradecyl Sulfate 1% 30 mL, 50 mL, Rx only, Green Valley Drugs, 1850 Whitney Mesa, #180, Henderson, NV 89014.","Lot #: a) Sodium Tetradecyl 3% 50 mL: 20130318-G, Exp 6/18/2013; b) Sodium Tetradecyl 3% mL: 20130218-G, Exp 5/18/2013; c) Sodium Tetradecyl-2% 30 mL: 20130122-B, Exp 4/22/2013; d) Sodium Tetradecyl-2.5% 20 mL: 20130114-D, Exp 4/14/2013; 20130117-C, Exp 4/17/2013 .",,"203 vials","Lack of Assurance of Sterility: all sterile products compounded, repackaged, and distributed by this compounding pharmacy due to lack of sterility assurance and concerns associated with the quality control processes.",4/10/2013,"04/10/2013",5/22/2013,"05/22/2013"
"Drugs",64879,"Ongoing","FVS Holdings, Inc. dba. Green Valley Drugs","Henderson","NV","US","Voluntary: Firm Initiated","Press Release","Nationwide","D-384-2013","Class II","Magnesium Sulfate Injection, all strengths and all presentations including a) Magnesium Sulfate 50%; b) MAGNESIUM SULFATE 50% 50 mL, c) Magnesium Sulfate PF 50% 2 mL, Rx only, Green Valley Drugs, 1850 Whitney Mesa, #180, Henderson, NV 89014.","Lot #: a) Magnesium Sulfate 50%: 20130130-F, Exp 4/30/2013; 20130128-F, Exp 4/28/2013; 20130221-T, Exp 5/21/2013; b) MAGNESIUM SULFATE 50% 50 mL: 20130322-E, Exp 6/22/2013; 20130219-C, Exp 5/19/2013; 20130307-A, Exp 6/7/2013; 20130404-G, Exp 7/4/2013; c) Magnesium Sulfate PF 50% 2 mL: 20130227-F, Exp 5/27/2013; 20130312-G, Exp 6/12/2013 ",,"529 vials","Lack of Assurance of Sterility: all sterile products compounded, repackaged, and distributed by this compounding pharmacy due to lack of sterility assurance and concerns associated with the quality control processes.",4/10/2013,"04/10/2013",5/22/2013,"05/22/2013"
"Drugs",64879,"Ongoing","FVS Holdings, Inc. dba. Green Valley Drugs","Henderson","NV","US","Voluntary: Firm Initiated","Press Release","Nationwide","D-392-2013","Class II","Lipotropic With Vitamins, Carnitine, Chromium and Glutamine Injection, all strengths and all presentations including Lipo W/Vitamin-Carn-Crom_Glut-30 mL, Rx only, Green Valley Drugs, 1850 Whitney Mesa, #180, Henderson, NV 89014.","Lot #: 130305600AE, Exp 6/5/2013",,"19 vials","Lack of Assurance of Sterility: all sterile products compounded, repackaged, and distributed by this compounding pharmacy due to lack of sterility assurance and concerns associated with the quality control processes.",4/10/2013,"04/10/2013",5/22/2013,"05/22/2013"
"Drugs",64879,"Ongoing","FVS Holdings, Inc. dba. Green Valley Drugs","Henderson","NV","US","Voluntary: Firm Initiated","Press Release","Nationwide","D-413-2013","Class II","Testosterone Cypionate Injection, all strengths and all presentations including a) Testosterone Cyp 200 mg/10 mL; b) Testosterone Cypionate 100 mg/10mL; c) Testosterone Cypionate 200 mg 10 mL; d) Testosterone Cypionate 200 mg 30 mL; e) Testosterone Cypionate 200 mg/mL; f) Testosterone Cypionate 200 mg/mL 30 mL; g) Testosterone Cypionate Sesame 200 mg/10 mL; h) Testosterone Cyp 250/30 mL; i) Testosterone Cypionate 200 mg/mL; Rx only, Green Valley Drugs, 1850 Whitney Mesa, #180, Henderson, NV 89014.","Lot #: a) Testosterone Cyp 200 mg/10 mL: 20130128-A, Exp 4/28/2013; b) Testosterone Cypionate 100 mg/10 mL: 20130226-G, Exp 5/26/2013; 130402100AE, Exp 7/2/2013; c) Testosterone Cypionate 200 mg 10 mL: 20130220-A, Exp 5/20/2013; 20130306-L, Exp 6/6/2013; 20130221-C, Exp 5/21/2013; 20130320-A, Exp 6/20/2013; 20130403-B, Exp 7/3/2013; 20130208-A, Exp 5/8/2013; 20130215-C, Exp 5/15/2013; d) Testosterone Cypionate 200 mg 30 mL: 20130208-A, Exp 5/8/2013; 20130121-A, Exp 4/21/2013; 20130129-A, Exp 4/29/2013; 20130221-C, Exp 5/21/2013; 20130314-J, Exp 6/14/2013; 20130318-O, Exp 6/18/2013; 20130326-A, Exp 6/26/2013; 20130220-A, Exp 5/20/2013; 20130402-E, Exp 7/2/2013; e) Testosterone Cypionate 200 mg/mL: 20130304-J, Exp 6/4/2013; f) Testosterone Cypionate 200 mg/mL 30 mL: 20130215-C, Exp 5/15/2013; g) Testosterone Cypionate Sesame 200 mg/10 mL: 20130405-C, Exp 7/5/2013; h) Tetosterone Cyp 250/30 mL: 20130118-A, Exp 4/18/2013",,"3727 vials and syringes","Lack of Assurance of Sterility: all sterile products compounded, repackaged, and distributed by this compounding pharmacy due to lack of sterility assurance and concerns associated with the quality control processes.",4/10/2013,"04/10/2013",5/22/2013,"05/22/2013"
"Drugs",64879,"Ongoing","FVS Holdings, Inc. dba. Green Valley Drugs","Henderson","NV","US","Voluntary: Firm Initiated","Press Release","Nationwide","D-386-2013","Class II","Medroxyprogesterone Acetate Injection, all strengths and all presentations including a) Medroxyprogesterone 150-30 mL, b) Medroxyprogesterone Acetate 150 mg/mL in 1 mL, 10 mL, 30 mL vials, c) Medroxyprogesterone Acetate 150 mg/mL PF syringe, d) Medroxyprogesterone Acetate 150 mg/mL syringe, Rx only, Green Valley Drugs, 1850 Whitney Mesa, #180, Henderson, NV 89014.","Lot #: a) Medroxyprogesterone 150-30 mL: 20130301-H, Exp 6/1/2013.",,"1299 vials and syringes","Lack of Assurance of Sterility: all sterile products compounded, repackaged, and distributed by this compounding pharmacy due to lack of sterility assurance and concerns associated with the quality control processes.",4/10/2013,"04/10/2013",5/22/2013,"05/22/2013"
"Drugs",64879,"Ongoing","FVS Holdings, Inc. dba. Green Valley Drugs","Henderson","NV","US","Voluntary: Firm Initiated","Press Release","Nationwide","D-354-2013","Class II","Vitamin D3 Injection, all strengths and all presentations including a) Cholecalciferol D3 50,000iu 30 mL, b) Calcitriol D3 10,000iu, and c) Calcitriol D3 50,000iu, Rx only, Green Valley Drugs, 1850 Whitney Mesa, #180, Henderson, NV 89014.","Lot #: 20130130-A, Exp 4/30/2013",,"18 vials","Lack of Assurance of Sterility: all sterile products compounded, repackaged, and distributed by this compounding pharmacy due to lack of sterility assurance and concerns associated with the quality control processes.",4/10/2013,"04/10/2013",5/22/2013,"05/22/2013"
"Drugs",64879,"Ongoing","FVS Holdings, Inc. dba. Green Valley Drugs","Henderson","NV","US","Voluntary: Firm Initiated","Press Release","Nationwide","D-397-2013","Class II","Nandrolone Decanoate Injection, all strengths and all presentations including a) Nandrolone Decanoate 300 mg/mL, b) Nandrolone 200 mg/mL, c) Nandrolone 250 mg/mL, d) Nandrolone 350 mg/mL, Rx only, Green Valley Drugs, 1850 Whitney Mesa, #180, Henderson, NV 89014.","Lot #: a) Nandrolone Decanoate 300 mg/mL: 20130311-J, Exp 6/11/2013",,"43 vials","Lack of Assurance of Sterility: all sterile products compounded, repackaged, and distributed by this compounding pharmacy due to lack of sterility assurance and concerns associated with the quality control processes.",4/10/2013,"04/10/2013",5/22/2013,"05/22/2013"
"Drugs",64879,"Ongoing","FVS Holdings, Inc. dba. Green Valley Drugs","Henderson","NV","US","Voluntary: Firm Initiated","Press Release","Nationwide","D-355-2013","Class II","Cyanocobalamin Injection, all strengths and all presentations including a) Cyanocobalamin 1000mcg, b) Cyanocobalamin 1000 mcg/mL in 1 mL, 10 mL, and 30 mL and 1 mL Preservative Free, Rx only, Green Valley Drugs, 1850 Whitney Mesa, #180, Henderson, NV 89014.","Lot #: a) Cyanocobalamin 1000mcg: 20130214-C, Exp 5/14/2013; 20130220-B, Exp 5/20/2013; 20130226-D, Exp 5/26/2013; 20130226-E, Exp 5/26/2013; 20130226-L, Exp 5/26/2013; 20130125-E, Exp 4/25/2013; 20130125-D, Exp 4/25/2013; 20130125-C, Exp 4/25/2013; 20130125-F, Exp 4/25/2013; 20130211-M, Exp 5/11/2013; 20130214-B, Exp 5/14/2013; 20130221-D, Exp 5/21/2013; 20130225-K, Exp 5/25/2013; 20130214-B, Exp 5/14/2013; 20130226-C, Exp 5/26/2013; 20130226-I, Exp 5/26/2013; 20130225-M, Exp 5/25/2013; 20130225-N, Exp 5/25/2013; 20130225-J, Exp 5/25/2013; 20130225-C, Exp 5/25/2013; 20130204-G, Exp 5/4/2013; 20130204-F, Exp 5/4/2013; b) Cyanocobalamin 1000mcg 30ml: 20130325-D, Exp 6/25/2013; 20130325-C, Exp 6/25/2013; 20130326-E, Exp 6/26/2013; 20130326-I, Exp 6/26/2013; 20130329-L, Exp 6/29/2013; 20130329-M, Exp 6/29/2013; 20130306-Q, Exp 6/6/2013; 20130308-K, Exp 6/8/2013; 20130401-O, Exp 7/1/2013; 20130401-M, Exp 7/1/2013; 20130402-C, Exp 7/2/2013; 20130402-B, Exp 7/2/2013; 20130329-K, Exp 6/29/2013; 20130308-L, Exp 6/8/2013; 20130401-N, Exp 7/1/2013; 20130402-H, Exp 7/2/2013; 20130402-D, Exp 7/2/2013; 20130402-A, Exp 7/2/2013; 20130403-A, Exp 7/3/2013; 20130318-P, Exp 6/18/2013; 20130318-O, Exp 6/18/2013; 20130318-Q, Exp 6/18/2013; 20130319-B, Exp 6/19/2013; 20130226-B, Exp 5/26/2013; 20130318-A, Exp 6/18/2013 ",,"6292 vials","Lack of Assurance of Sterility: all sterile products compounded, repackaged, and distributed by this compounding pharmacy due to lack of sterility assurance and concerns associated with the quality control processes.",4/10/2013,"04/10/2013",5/22/2013,"05/22/2013"
"Drugs",64879,"Ongoing","FVS Holdings, Inc. dba. Green Valley Drugs","Henderson","NV","US","Voluntary: Firm Initiated","Press Release","Nationwide","D-341-2013","Class II","Amikacin Injection, all strengths and all presentations including 50, 30 mL, Rx only, Green Valley Drugs, 1850 Whitney Mesa, #180, Henderson, NV 89014.","Lot #: 20130116-A, Exp 04/16/13",,"unknown","Lack of Assurance of Sterility: all sterile products compounded, repackaged, and distributed by this compounding pharmacy due to lack of sterility assurance and concerns associated with the quality control processes.",4/10/2013,"04/10/2013",5/22/2013,"05/22/2013"
"Drugs",64879,"Ongoing","FVS Holdings, Inc. dba. Green Valley Drugs","Henderson","NV","US","Voluntary: Firm Initiated","Press Release","Nationwide","D-345-2013","Class II","B-Complex Injection, all strengths and all presentations including a) B-Complex Injection 30 mL; b) B-Complex PF 2 mL; c) B-Complex Plus-100; d) B-Complex_B12_30 mL; e) B-Complex-50-Methyl-30-Lido 30 mL; f) B-CompSuper-30 mL, Rx only, Green Valley Drugs, 1850 Whitney Mesa, #180, Henderson, NV 89014.","Lot #: a) B-Complex: 20130228-B, Exp 5/28/2013; 20130125-B, Exp 4/25/2013; b) B-Complex PF 2ml: 20130219-D, Exp 5/19/2013; 20130319 -J, Exp 6/19/2013; c) B-Complex Plus-100: 20130307-D, Exp 6/7/2013; 20130123-E, Exp 4/23/2013; d) B-Complex_B12_30ml: 20130212-F, Exp 5/12/2013; e) B-Complex-50-Methyl-30-Lido 30ml: 20130206-M, Exp 5/6/2013; f) B-CompSuper-30ml: 1302042000AE, Exp 5/4/2013. ",,"679 vials","Lack of Assurance of Sterility: all sterile products compounded, repackaged, and distributed by this compounding pharmacy due to lack of sterility assurance and concerns associated with the quality control processes.",4/10/2013,"04/10/2013",5/22/2013,"05/22/2013"
"Drugs",64879,"Ongoing","FVS Holdings, Inc. dba. Green Valley Drugs","Henderson","NV","US","Voluntary: Firm Initiated","Press Release","Nationwide","D-366-2013","Class II","Folic Acid Injection, all strengths and all presentations including a) Folic Acid 10 mg/mL 30 mL; b) Folic Acid PF 10 mg/mL 2 mL and 5 mL; c) Folic Acid 20 mg/mL 30 mL; d) Folic Acid 5 mg/mL 5 mL, 10 ml and 30 mL Rx only, Green Valley Drugs, 1850 Whitney Mesa, #180, Henderson, NV 89014.","Lot #: a) Folic Acid 10 mg/30 mL: 20130204-D, Exp 5/4/2013; b) Folic Acid PF 10mg/mL 2 mL: 20130219-E, Exp 5/15/2013 ",,"244 vials","Lack of Assurance of Sterility: all sterile products compounded, repackaged, and distributed by this compounding pharmacy due to lack of sterility assurance and concerns associated with the quality control processes.",4/10/2013,"04/10/2013",5/22/2013,"05/22/2013"
"Drugs",64879,"Ongoing","FVS Holdings, Inc. dba. Green Valley Drugs","Henderson","NV","US","Voluntary: Firm Initiated","Press Release","Nationwide","D-370-2013","Class II","Human Chorionic Gonadotropin Injection, all strengths and all presentations including a) HCG 1000u/mL, b) HCG 1000u/mL 10mL, c) HCG 1000u Folic 400 mcg Methyl 5 mg 10 mL, d) HCG Kit 1 Day w/ Drug; HCT 750u/0.75 mL Pre-Filled Syringe, e) HCG Syringe 150iu/0.15 mL, f) HCG 1500u/1.5 mL Pre-Filled Syringe, g) HCG 5000 unit/5 mL vial, Rx only, Green Valley Drugs, 1850 Whitney Mesa, #180, Henderson, NV 89014.","Lot #: a) HCG 1000u/mL: 20130319-E, Exp 5/19/2013; b) HCG 1000u/mL 10mL: 20130221-J, Exp 4/21/2013",,"5255 vials and syringes","Lack of Assurance of Sterility: all sterile products compounded, repackaged, and distributed by this compounding pharmacy due to lack of sterility assurance and concerns associated with the quality control processes.",4/10/2013,"04/10/2013",5/22/2013,"05/22/2013"
"Drugs",64879,"Ongoing","FVS Holdings, Inc. dba. Green Valley Drugs","Henderson","NV","US","Voluntary: Firm Initiated","Press Release","Nationwide","D-412-2013","Class II","Testosterone Propionate, Testosterone Cypionate, and Nandrolone Decanoate Injection, all strengths and all presentations including Test Prop 100 mg/Test Cyp 50 mg/nandro dec 150 mg/ml, Rx only, Green Valley Drugs, 1850 Whitney Mesa, #180, Henderson, NV 89014.","Lot #: 20130122-G, Exp 4/22/2013",,"2 vials","Lack of Assurance of Sterility: all sterile products compounded, repackaged, and distributed by this compounding pharmacy due to lack of sterility assurance and concerns associated with the quality control processes.",4/10/2013,"04/10/2013",5/22/2013,"05/22/2013"
"Drugs",64879,"Ongoing","FVS Holdings, Inc. dba. Green Valley Drugs","Henderson","NV","US","Voluntary: Firm Initiated","Press Release","Nationwide","D-346-2013","Class II","Betamethasone Combination Injection, all strengths and all presentations including a) Beta combo 6 mg/mL, 3 mL, b) Betameth_Combo_PF-6-2 Syr, and c) Betamethasone Combo 6 mg/mL Syr, Rx only, Green Valley Drugs, 1850 Whitney Mesa, #180, Henderson, NV 89014.","Lot #: a) Beta combo: 20130123-B, Exp 4/23/201, b) Betameth_Combo_PF-6-2 Syr: 13031230GV1, Exp 6/12/2013; 13032060GV2, Exp 6/20/2013; 13011650GV7, Exp 4/16/2013; 13012330GV1, Exp 4/23/2013; 13020525Gv1, Exp 5/5/2013; c) Betamethasone Combo 6mg/ml Syr: 20130304-GV2, Exp 5/4/2013; 13031230GV1, Exp 6/12/2013",,"295 vials and syringes","Lack of Assurance of Sterility: all sterile products compounded, repackaged, and distributed by this compounding pharmacy due to lack of sterility assurance and concerns associated with the quality control processes.",4/10/2013,"04/10/2013",5/22/2013,"05/22/2013"
"Drugs",64879,"Ongoing","FVS Holdings, Inc. dba. Green Valley Drugs","Henderson","NV","US","Voluntary: Firm Initiated","Press Release","Nationwide","D-410-2013","Class II","Testosterone Cypionate and Testosterone Propionate Injection, all strengths and all presentations including a) Testosterone cyp 200/test prop 20 mg 10 mL and b) Testosterone Cyp 200 mg/Test Prop 50 mg 10mL, Rx only, Green Valley Drugs, 1850 Whitney Mesa, #180, Henderson, NV 89014.","Lot #: a) Testosterone cyp 200/test prop 20 mg 10 mL: 130102500AE, Exp 4/25/2013; b) Testosterone Cyp 200 mg/Test Prop 50 mg 10 mL: 20130305-1, Exp 6/5/2013",,"51 vials","Lack of Assurance of Sterility: all sterile products compounded, repackaged, and distributed by this compounding pharmacy due to lack of sterility assurance and concerns associated with the quality control processes.",4/10/2013,"04/10/2013",5/22/2013,"05/22/2013"
"Drugs",64879,"Ongoing","FVS Holdings, Inc. dba. Green Valley Drugs","Henderson","NV","US","Voluntary: Firm Initiated","Press Release","Nationwide","D-376-2013","Class II","Ketorolac Injection, all strengths and all presentations including a) Ketorolac 30 mg/mL 10 mL MDV, b) Ketorolac 30 mg/mL 2 mL SDV, c) Ketorolac 30 mg/mL 1 mL SDV, Rx only, Green Valley Drugs, 1850 Whitney Mesa, #180, Henderson, NV 89014.","Lot #: a) Ketorolac 30 mg/mL 10 mL: 20130327-B, Exp 6/27/2013; b) Ketorolac 30 mg/mL 2 mL: 20130326-B, Exp 6/26/2013; 20130307-C, Exp 6/7/2013 ",,"3289 vials","Lack of Assurance of Sterility: all sterile products compounded, repackaged, and distributed by this compounding pharmacy due to lack of sterility assurance and concerns associated with the quality control processes.",4/10/2013,"04/10/2013",5/22/2013,"05/22/2013"
"Drugs",64879,"Ongoing","FVS Holdings, Inc. dba. Green Valley Drugs","Henderson","NV","US","Voluntary: Firm Initiated","Press Release","Nationwide","D-375-2013","Class II","Hydroxyprogesterone Caproate Injection, all strengths and all presentations including Hydroxyprogesterone Caproate 250 mg/mL 1 mL, 4 mL, 5 mL, 10 mL, Rx only, Green Valley Drugs, 1850 Whitney Mesa, #180, Henderson, NV 89014.","Lot #: Hydroxyprogesterone Caproate 250 mg/mL 4 mL: 20130204-A, Exp 5/4/2013; 20130117-G, Exp 4/17/2013; 20130204-A, Exp 5/4/2013 ",,"229 vials","Lack of Assurance of Sterility: all sterile products compounded, repackaged, and distributed by this compounding pharmacy due to lack of sterility assurance and concerns associated with the quality control processes.",4/10/2013,"04/10/2013",5/22/2013,"05/22/2013"
"Drugs",64879,"Ongoing","FVS Holdings, Inc. dba. Green Valley Drugs","Henderson","NV","US","Voluntary: Firm Initiated","Press Release","Nationwide","D-407-2013","Class II","Sodium Bicarbonate Injection, all strengths and all presentations including: a) Sodium Bicarb 4.2% 5 mL PF, b) Sodium Bicarb 8.4% 50 mL SDV, c) Sodium Bicarbonate 8.4%, Rx only, Green Valley Drugs, 1850 Whitney Mesa, #180, Henderson, NV 89014.","Lot #: Sodium Bicarb 4.2% 5 mL PF: 130123150AE, Exp 4/23/2013; b) Sodium Bicarb 8.4% 50 mL SDV: 20130315-L, Exp 6/15/2013; c) Sodium Bicarbonate 8.4%: 20130117-D, Exp 4/17/2013; 20130117-E, Exp 4/17/2013; 20130117-F, Exp 4/17/2013; 20130121-B, Exp 4/21/2013; 20130121-C, Exp 4/21/2013; 20130121-D, Exp 4/21/2013; 20130121-E, Exp 4/21/2013; 20130121-F, Exp 4/21/2013; 20130121-H, Exp 4/21/2013; 20130121-I, Exp 4/21/2013; 20130121-J, Exp 4/21/2013; 20130121-K, Exp 4/21/2013; 20130124-D, Exp 4/24/2013; 20130124-E, Exp 4/24/2013; 20130129-B, Exp 4/29/2013; 20130129-C, Exp 4/29/2013; 20130129-D, Exp 4/29/2013; 20130129-K, Exp 4/29/2013; 20130129-L, Exp 4/29/2013; 20130129-M, Exp 4/29/2013; 20130131-I, Exp 4/30/2013; 20130131-J, Exp 4/30/2013; 20130131-K, Exp 4/30/2013; 20130201-B, Exp 5/1/2013; 20130201-C, Exp 5/1/2013; 20130211-A, Exp 5/11/2013; 20130211-B, Exp 5/11/2013; 20130211-C, Exp 5/11/2013; 20130211-D, Exp 5/11/2013; 20130211-E, Exp 5/11/2013; 20130211-F, Exp 5/11/2013; 20130211-G, Exp 5/11/2013; 20130211-H, Exp 5/11/2013; 20130211-I, Exp 5/11/2013; 20130211-J, Exp 5/11/2013; 20130211-K, Exp 5/11/2013; 20130211-L, Exp 5/11/2013; 20130211-N, Exp 5/11/2013; 20130211-O, Exp 5/11/2013; 20130211-P, Exp 5/11/2013; 20130211-Q, Exp 5/11/2013; 20130211-R, Exp 5/11/2013; 20130211-S, Exp 5/11/2013; 20130211-T, Exp 5/11/2013; 20130214-D, Exp 5/14/2013; 20130214-E, Exp 5/14/2013; 20130214-H, Exp 5/14/2013; 20130215-A, Exp 5/15/2013; 20130215-B, Exp 5/15/2013; 20130215-D, Exp 5/15/2013; 20130215-E, Exp 5/15/2013; 20130215-G, Exp 5/15/2013; 20130215-H, Exp 5/15/2013; 13021840GV3, Exp 5/18/2013; 20130219-G, Exp 5/19/2013; 20130219-H, Exp 5/19/2013; 20130219-I, Exp 5/19/2013; 20130219-J, Exp 5/19/2013; 20130221-B, Exp 5/21/2013; 20130221-A, Exp 5/21/2013; 20130221-E, Exp 5/21/2013; 20130221-F, Exp 5/21/2013; 20130221-G, Exp 5/21/2013; 20130221-H, Exp 5/21/2013; 20130221-P, Exp 5/21/2013; 20130221-Q, Exp 5/21/2013; 20130221-S, Exp 5/21/2013; 20130222-B, Exp 5/22/2013; 20130222-C, Exp 5/22/2013; 20130225-E, Exp 5/25/2013; 20130",,"6213 vials","Lack of Assurance of Sterility: all sterile products compounded, repackaged, and distributed by this compounding pharmacy due to lack of sterility assurance and concerns associated with the quality control processes.",4/10/2013,"04/10/2013",5/22/2013,"05/22/2013"
"Drugs",64879,"Ongoing","FVS Holdings, Inc. dba. Green Valley Drugs","Henderson","NV","US","Voluntary: Firm Initiated","Press Release","Nationwide","D-353-2013","Class II","Buprenorphine Injection, all strengths and all presentations including Buprenorphine-0.3 30 mL, Rx only, Green Valley Drugs, 1850 Whitney Mesa, #180, Henderson, NV 89014.","Lot #: 130129300AEB, Exp 4/29/2013.",,"2 vials","Lack of Assurance of Sterility: all sterile products compounded, repackaged, and distributed by this compounding pharmacy due to lack of sterility assurance and concerns associated with the quality control processes.",4/10/2013,"04/10/2013",5/22/2013,"05/22/2013"
"Drugs",64879,"Ongoing","FVS Holdings, Inc. dba. Green Valley Drugs","Henderson","NV","US","Voluntary: Firm Initiated","Press Release","Nationwide","D-374-2013","Class II","Hydroxocobalamin Injection, all strengths and all presentations including a) Hydroxocobalamin 1000 mcg/mL 30mL and b) Hydroxocobalamin 1000 mcg/mL 10 mL P.F., Rx only, Green Valley Drugs, 1850 Whitney Mesa, #180, Henderson, NV 89014.","Lot #: a) Hydroxocobalamin 1000 mcg/mL 30 mL: 20130321-C, Exp 6/21/2013; 20130404-H, Exp 7/3/2013; 20130225-H, Exp 5/25/2013 ",,"135 vials","Lack of Assurance of Sterility: all sterile products compounded, repackaged, and distributed by this compounding pharmacy due to lack of sterility assurance and concerns associated with the quality control processes.",4/10/2013,"04/10/2013",5/22/2013,"05/22/2013"
"Drugs",64879,"Ongoing","FVS Holdings, Inc. dba. Green Valley Drugs","Henderson","NV","US","Voluntary: Firm Initiated","Press Release","Nationwide","D-381-2013","Class II","Lipotropic With Vitamins with Methylcobalamin Injections, all strengths and all presentations including a) Lipo w/Vitamins-methylcobalamin 100 mL, 30 mL, and b) Lipo w/ Vitamins, Folic, Methylcobalamin 30 mL, Rx only, Green Valley Drugs, 1850 Whitney Mesa, #180, Henderson, NV 89014.","Lot #: a) Lipo w/Vitamins-methylcobalamin 100 mL: 20130225-A, Exp 5/25/2013; 20130326-D, Exp 6/26/2013 ",,"176 vials","Lack of Assurance of Sterility: all sterile products compounded, repackaged, and distributed by this compounding pharmacy due to lack of sterility assurance and concerns associated with the quality control processes.",4/10/2013,"04/10/2013",5/22/2013,"05/22/2013"
"Drugs",64879,"Ongoing","FVS Holdings, Inc. dba. Green Valley Drugs","Henderson","NV","US","Voluntary: Firm Initiated","Press Release","Nationwide","D-382-2013","Class II","L-Lysine Injection, all strengths and all presentations including a) L-Lysine_100-30 mL, b) L-Lysine_100 mg/30 mL, Rx only, Green Valley Drugs, 1850 Whitney Mesa, #180, Henderson, NV 89014.","Lot #: a) L-Lysine_100-30 mL: 130117300AE, Exp 4/17/2013; 20130118-F, Exp 4/18/2013; 20130129-G, Exp 4/29/2013; 20130131-G, Exp 4/30/2013; b) L-Lysine_100 mg/30 mL: 20130405-E, Exp 7/5/2013 ",,"132 vials","Lack of Assurance of Sterility: all sterile products compounded, repackaged, and distributed by this compounding pharmacy due to lack of sterility assurance and concerns associated with the quality control processes.",4/10/2013,"04/10/2013",5/22/2013,"05/22/2013"
"Drugs",64879,"Ongoing","FVS Holdings, Inc. dba. Green Valley Drugs","Henderson","NV","US","Voluntary: Firm Initiated","Press Release","Nationwide","D-368-2013","Class II","Gentamicin Injection, all strengths and all presentations including a) Gentamicin 40 mg/2 mL, b) Gentamicin 40 mg/30 mL, c) Gentamicin-40-20 mL, d) Gentamicin-40 mg/mL-2 mL, Rx only, Green Valley Drugs, 1850 Whitney Mesa, #180, Henderson, NV 89014.","Lot #: a) Gentamicin 40 mg/2 mL: 20130403-D, Exp 7/3/2013; 20130227-H, Exp 5/27/2013; b) Gentamicin 40 mg/30 mL: 20130204-E, Exp 5/4/2013; c) Gentamicin-40-20 mL: 20130204-E, Exp 5/4/2013; d) Gentamicin-40 mg/mL-2 mL; 20130227-A, Exp 5/27/2013 ",,"1140 vials","Lack of Assurance of Sterility: all sterile products compounded, repackaged, and distributed by this compounding pharmacy due to lack of sterility assurance and concerns associated with the quality control processes.",4/10/2013,"04/10/2013",5/22/2013,"05/22/2013"
"Drugs",64879,"Ongoing","FVS Holdings, Inc. dba. Green Valley Drugs","Henderson","NV","US","Voluntary: Firm Initiated","Press Release","Nationwide","D-362-2013","Class II","Edetate Calcium Disodium Injection, all strengths and all presentations including a) Edetate Calcium Disodium 300 mg/mL 100 mL, b) Edetate Calcium Disodium 300-30 mL, c) Calcium Edetate 200 mg/mL 15 mL, Rx only, Green Valley Drugs, 1850 Whitney Mesa, #180, Henderson, NV 89014.","Lot #: a) Edatate Calcium Disodium 300 mg/mL 100mL: 20130319-H, Exp 6/19/2013; 2010318-N, Exp 6/18/2013; b) Edetate Calcium Disodium 300-30 mL: 20130205-H, Exp 5/5/2013; 20130318-N, Exp 6/18/2013; 20130319-H, Exp 6/19/2013 ",,"227 vials","Lack of Assurance of Sterility: all sterile products compounded, repackaged, and distributed by this compounding pharmacy due to lack of sterility assurance and concerns associated with the quality control processes.",4/10/2013,"04/10/2013",5/22/2013,"05/22/2013"
"Drugs",64879,"Ongoing","FVS Holdings, Inc. dba. Green Valley Drugs","Henderson","NV","US","Voluntary: Firm Initiated","Press Release","Nationwide","D-380-2013","Class II","Lipotropic With Vitamin Injections, all strengths and all presentations including a) Lipo W/ Vitamin 100 mL, b) Lipo W/ Vitamins 30 mL, c) Lipo W/Vitamin, d) Lipo w/Vitamins #5 30 mL, Rx only, Green Valley Drugs, 1850 Whitney Mesa, #180, Henderson, NV 89014.","Lot #: a) Lipo W/ Vitamin 100 mL: 20130322-D, Exp 6/22/2013; 20130115-H, Exp 4/15/2013; b) Lipo W/ Vitamins 30 mL: 20130228-H, Exp 5/28/2013; 20130228-H, Exp 5/28/2013; 20130322-D, Exp 6/22/2013; 20130208-J, Exp 5/8/2013; c) Lipo W/Vitamin: 20130228-H, Exp 5/28/2013; d) Lipo w/Vitamins #5 30 mL: 201301281000IN, Exp 4/28/2013 ",,"209 vials","Lack of Assurance of Sterility: all sterile products compounded, repackaged, and distributed by this compounding pharmacy due to lack of sterility assurance and concerns associated with the quality control processes.",4/10/2013,"04/10/2013",5/22/2013,"05/22/2013"
"Drugs",64879,"Ongoing","FVS Holdings, Inc. dba. Green Valley Drugs","Henderson","NV","US","Voluntary: Firm Initiated","Press Release","Nationwide","D-399-2013","Class II","Phosphatidylcholine and Sodium Deoxycholate Injection, all strengths and all presentations including Phospha_Deoxy-35-30-50 mL, Rx only, Green Valley Drugs, 1850 Whitney Mesa, #180, Henderson, NV 89014.","Lot #: 201303071500JN, Exp 6/7/2013; 1301231000AE, Exp 4/23/2013 ",,"40 vials","Lack of Assurance of Sterility: all sterile products compounded, repackaged, and distributed by this compounding pharmacy due to lack of sterility assurance and concerns associated with the quality control processes..",4/10/2013,"04/10/2013",5/22/2013,"05/22/2013"
"Drugs",64879,"Ongoing","FVS Holdings, Inc. dba. Green Valley Drugs","Henderson","NV","US","Voluntary: Firm Initiated","Press Release","Nationwide","D-411-2013","Class II","Taurine Injection, all strengths and all presentations including a) Taurine 50 mg/mL, b) Taurine-50-30 mL, c) Taurine-50 mg-30 mL, Rx only, Green Valley Drugs, 1850 Whitney Mesa, #180, Henderson, NV 89014.","Lot #: Taurine 50 mg/mL: 20130305-A, Exp 6/5/2013; Taurine-50-30 mL: 20130123-D, Exp 4/23/2013; Taurine-50mg-30 mL: 21030117-J, Exp 4/17/2013 ",,"50 vials","Lack of Assurance of Sterility: all sterile products compounded, repackaged, and distributed by this compounding pharmacy due to lack of sterility assurance and concerns associated with the quality control processes.",4/10/2013,"04/10/2013",5/22/2013,"05/22/2013"
"Drugs",64879,"Ongoing","FVS Holdings, Inc. dba. Green Valley Drugs","Henderson","NV","US","Voluntary: Firm Initiated","Press Release","Nationwide","D-385-2013","Class II","Manganese Sulfate Injection, all strengths and all presentations including a) Manganese-0.1 30 mL, b) Manganese Sulfate 0.1 mg/30 mL, c) Manganese Sulfate 5 mg/5 mg, Rx only, Green Valley Drugs, 1850 Whitney Mesa, #180, Henderson, NV 89014.","Lot #: a) Manganese-0.1 30 mL: 20130129500JN, Exp 4/29/2013; 1301302000AE, Exp 4/30/2013; b) Manganese Sulfate 0.1 mg/30 mL: 20130405-G, Exp 7/5/2013; c) Manganese Sulfate 5 mg/5 mL: 20130122-4, Exp 4/22/2013 ",,"133 vials","Lack of Assurance of Sterility: all sterile products compounded, repackaged, and distributed by this compounding pharmacy due to lack of sterility assurance and concerns associated with the quality control processes.",4/10/2013,"04/10/2013",5/22/2013,"05/22/2013"
"Drugs",64879,"Ongoing","FVS Holdings, Inc. dba. Green Valley Drugs","Henderson","NV","US","Voluntary: Firm Initiated","Press Release","Nationwide","D-348-2013","Class II","Betamethasone Sodium Phosphate Injection, all strengths and all presentations including 6 mg/2 mL PF and 6 mg/mL; Rx only, Green Valley Drugs, 1850 Whitney Mesa, #180, Henderson, NV 89014.","Lot #: 20130405-F, Exp 7/5/2013; 20130222-A, Exp 5/22/2013; 20130405-F, Exp 7/5/2013",,"65 vials","Lack of Assurance of Sterility: all sterile products compounded, repackaged, and distributed by this compounding pharmacy due to lack of sterility assurance and concerns associated with the quality control processes.",4/10/2013,"04/10/2013",5/22/2013,"05/22/2013"
"Drugs",64879,"Ongoing","FVS Holdings, Inc. dba. Green Valley Drugs","Henderson","NV","US","Voluntary: Firm Initiated","Press Release","Nationwide","D-415-2013","Class II","Triamcinolone Injection, all strengths and all presentations including a) Triamcinolone 40 mg/1 mL PF, b) Triamcinolone Acetonide 45 mg/mL, c) Triamcinolone 50 mg/mL 5 mL PF, d) Triamcinolone 45 mg/mL10 mL, 30 mL, e) Triamcinolone 40 mg/mL SDV PF 1 mL, 2 mL, Rx only, Green Valley Drugs, 1850 Whitney Mesa, #180, Henderson, NV 89014.","Lot #: a) Triamcinolone 40 mg/1 mL PF: 20130314-K, Exp 6/14/2013;b) Triamcinolone Acetonide 45 mg/mL: 20130129-I, Exp 4/29/2013; 20130208-B, Exp 5/8/2013; 20130314-K, Exp 6/14/2013; 20130318-E, Exp 6/18/2013; 20130308-1, Exp 6/8/2013 ",,"1423 vials","Lack of Assurance of Sterility: all sterile products compounded, repackaged, and distributed by this compounding pharmacy due to lack of sterility assurance and concerns associated with the quality control processes.",4/10/2013,"04/10/2013",5/22/2013,"05/22/2013"
"Drugs",64879,"Ongoing","FVS Holdings, Inc. dba. Green Valley Drugs","Henderson","NV","US","Voluntary: Firm Initiated","Press Release","Nationwide","D-365-2013","Class II","Estradiol Valerate Injection, all strengths and all presentations including a) Estradiol Valerate 40-10 mL and b) Estradiol Valerate 40-30 mL, Rx only, Green Valley Drugs, 1850 Whitney Mesa, #180, Henderson, NV 89014.","Lot #: 20130114-B, Exp 4/14/2013 ",,"243 vials","Lack of Assurance of Sterility: all sterile products compounded, repackaged, and distributed by this compounding pharmacy due to lack of sterility assurance and concerns associated with the quality control processes.",4/10/2013,"04/10/2013",5/22/2013,"05/22/2013"
"Drugs",64879,"Ongoing","FVS Holdings, Inc. dba. Green Valley Drugs","Henderson","NV","US","Voluntary: Firm Initiated","Press Release","Nationwide","D-404-2013","Class II","Sodium Chloride and Dexamethasone Injection, all strengths and all presentations including a) SOD_CHLOR-DEXAMETH-0.9-10-3, b) SOD_CHLORIDE/DEXAMETH syringe 0.9-10-3, Rx only, Green Valley Drugs, 1850 Whitney Mesa, #180, Henderson, NV 89014.","Lot #: a) SOD_CHLOR-DEXAMETH-0.9-10-3: 13011450GV3, Exp 4/14/2013; 13011450GV2, Exp 4/14/2013; 13011760A, Exp 4/17/2013; 13012440, Exp 4/24/2013; 13020425GV2, Exp 5/4/2013; 2013021950GV1, Exp 5/19/2013; b) SOD_CHLORIDE/DEXAMETH syringe 0.9-10-3: 13031330GV1, Exp 6/13/2013; 13031460GV1, Exp 6/14/2013; 13032740GV2, Exp 6/27/2013; 20130327GV1, Exp 6/27/2013; 13021920GV1, Exp 5/19/2013; 130301100GV3, Exp 6/1/2013; 20130222GV2, Exp 5/22/2013; 13020850GV1, Exp 5/8/2013 ",,"950 syringes","Lack of Assurance of Sterility: all sterile products compounded, repackaged, and distributed by this compounding pharmacy due to lack of sterility assurance and concerns associated with the quality control processes.",4/10/2013,"04/10/2013",5/22/2013,"05/22/2013"
"Drugs",64879,"Ongoing","FVS Holdings, Inc. dba. Green Valley Drugs","Henderson","NV","US","Voluntary: Firm Initiated","Press Release","Nationwide","D-352-2013","Class II","Bupivacaine Injection, all strengths and all presentations including a) Bupivacaine Parabens Free 0.5% 50 mL, and b) Bupivacaine PF 0.5% 30 mL SDV, Rx only, Green Valley Drugs, 1850 Whitney Mesa, #180, Henderson, NV 89014.","Lot #: a) Bupivacaine PF 0.5% 30 mL SDV: 20130318-C, Exp 6/18/2013; 20130319-F, Exp 6/19/2013; b) Bupivacaine Paraben Free 0.5% 50 mL: 20130212-E, Exp 5/12/2013; 20130124-F, Exp 4/24/2013; 20130214-G, Exp 5/14/2013; 20130320-E, Exp 6/20/2013 ",,"756 vials","Lack of Assurance of Sterility: all sterile products compounded, repackaged, and distributed by this compounding pharmacy due to lack of sterility assurance and concerns associated with the quality control processes.",4/10/2013,"04/10/2013",5/22/2013,"05/22/2013"
"Drugs",64879,"Ongoing","FVS Holdings, Inc. dba. Green Valley Drugs","Henderson","NV","US","Voluntary: Firm Initiated","Press Release","Nationwide","D-373-2013","Class II","Hydrogen Peroxide Injection, all strengths and all presentations including Hydrogen Peroxide 3% 30 mL, Rx only, Green Valley Drugs, 1850 Whitney Mesa, #180, Henderson, NV 89014.","Lot #: 20130225-H, Exp 5/25/2013; 20130130-I, Exp 4/30/2013; 20130311-I, Exp 6/11/2013. ",,"140 vials","Lack of Assurance of Sterility: all sterile products compounded, repackaged, and distributed by this compounding pharmacy due to lack of sterility assurance and concerns associated with the quality control processes.",4/10/2013,"04/10/2013",5/22/2013,"05/22/2013"
"Drugs",64879,"Ongoing","FVS Holdings, Inc. dba. Green Valley Drugs","Henderson","NV","US","Voluntary: Firm Initiated","Press Release","Nationwide","D-387-2013","Class II","Methylcobalamin Injection, all strengths and all presentations including a) Methylcobalamin 1000 mcg/mL in 10 mL, 30 mL, 50 mL, 60 mL, b) Methylcobalamin 1000 mcg 30 mL, c) Methylcobalamin 5 mg/mL 30 mL, d) Methylcobalamin PF 1000 mcg/mL in 2 mL, 5 mL, 10 mL, Rx only, Green Valley Drugs, 1850 Whitney Mesa, #180, Henderson, NV 89014.","Lot #: a) Methylcobalamin 1000 mcg: 20130208-G, Exp 5/8/2013; 20130118-G, Exp 4/18/2013; 20130129-E, Exp 4/29/2013; 20130212-B, Exp 5/12/2013; 20130221-I , Exp 5/21/2013; 20130206-D, Exp 5/6/2013; 20130301-E, Exp 6/1/2013; 20130305-C, Exp 6/5/2013; b) Methylcobalamin 1000 mcg 30 mL: 20130308-G, Exp 6/8/2013; c) Methylcobalamin 5 mg/30 mL: 20130214-I, Exp 5/14/2013; d) Methylcobalamin PF 1000 mcg: 20130312-G, Exp 6/12/2013 ",,"1343 vials","Lack of Assurance of Sterility: all sterile products compounded, repackaged, and distributed by this compounding pharmacy due to lack of sterility assurance and concerns associated with the quality control processes.",4/10/2013,"04/10/2013",5/22/2013,"05/22/2013"
"Drugs",64879,"Ongoing","FVS Holdings, Inc. dba. Green Valley Drugs","Henderson","NV","US","Voluntary: Firm Initiated","Press Release","Nationwide","D-347-2013","Class II","BET-ACE-LIDO-6-2 Injection, all strengths and all presentations including 7 mL syringe and Betameth Combo 6 mg/mL Lidocaine 2% Syringe, Rx only, Green Valley Drugs, 1850 Whitney Mesa, #180, Henderson, NV 89014.","Lot #: 13012320-GV1, Exp 4/23/2013; 13021840GV1, Exp 5/18/2013; 13031150GV1, Exp 6/11/2013; 13021840GV1, Exp 5/18/2013; 13012320-GV1, Exp 4/23/2013; 13011532, Exp 4/15/2013. ",,"435 vials and syringes","Lack of Assurance of Sterility: all sterile products compounded, repackaged, and distributed by this compounding pharmacy due to lack of sterility assurance and concerns associated with the quality control processes.",4/10/2013,"04/10/2013",5/22/2013,"05/22/2013"
"Drugs",64879,"Ongoing","FVS Holdings, Inc. dba. Green Valley Drugs","Henderson","NV","US","Voluntary: Firm Initiated","Press Release","Nationwide","D-390-2013","Class II","Methylprednisolone and Bupivacaine Injection, all strengths and all presentations including Methylpred80mg/bupivacaine0.25% syr; Rx only, Green Valley Drugs, 1850 Whitney Mesa, #180, Henderson, NV 89014.","Lot #: 13012335-GV4, Exp 4/23/2013;; 20130226-GV2, Exp 5/26/2013; 130312200GV3, Exp 6/12/2013 ",,"52 syringes","Lack of Assurance of Sterility: all sterile products compounded, repackaged, and distributed by this compounding pharmacy due to lack of sterility assurance and concerns associated with the quality control processes.",4/10/2013,"04/10/2013",5/22/2013,"05/22/2013"
"Drugs",64879,"Ongoing","FVS Holdings, Inc. dba. Green Valley Drugs","Henderson","NV","US","Voluntary: Firm Initiated","Press Release","Nationwide","D-372-2013","Class II","Hydrochloric Acid Injection, all strengths and all presentations including a) Hydrochloric Acid 0.6%, b) Hydrochloric Acid 2%, c) Hydrochloric Acid Injection 0.06% 30 mL, d) Hydrochloric Acid 2 mg/mL Injection 30 mL vial, Rx only, Green Valley Drugs, 1850 Whitney Mesa, #180, Henderson, NV 89014.","Lot #: a) Hydrochloric Acid 0.6%: 20130212-H, Exp 5/12/2013; b) Hydrochloric Acid 2%: 2013012952000AE, Exp 4/29/2013 .",,"63 vials","Lack of Assurance of Sterility: all sterile products compounded, repackaged, and distributed by this compounding pharmacy due to lack of sterility assurance and concerns associated with the quality control processes.",4/10/2013,"04/10/2013",5/22/2013,"05/22/2013"
"Drugs",64879,"Ongoing","FVS Holdings, Inc. dba. Green Valley Drugs","Henderson","NV","US","Voluntary: Firm Initiated","Press Release","Nationwide","D-360-2013","Class II","Dimethyl Sulfoxide (DMSO) Injection, all strengths and all presentations including DMSO 99% 50 mL, Rx only, Green Valley Drugs, 1850 Whitney Mesa, #180, Henderson, NV 89014.","Lot #: 20130130-L, Exp 4/30/2013; 20130306-G, Exp 6/6/2013; 20130131-L, Exp 4/30/2013 ",,"unknown","Lack of Assurance of Sterility: all sterile products compounded, repackaged, and distributed by this compounding pharmacy due to lack of sterility assurance and concerns associated with the quality control processes.",4/10/2013,"04/10/2013",5/22/2013,"05/22/2013"
"Drugs",64879,"Ongoing","FVS Holdings, Inc. dba. Green Valley Drugs","Henderson","NV","US","Voluntary: Firm Initiated","Press Release","Nationwide","D-367-2013","Class II","Furosemide Injection, all strengths and all presentations including a) Furosemide PF-10 mg-10 mL, b) Furosemide PF-10 mg-2 mL SDV, and Furosemide 10 mg/mL 4 mL SDV, Rx only, Green Valley Drugs, 1850 Whitney Mesa, #180, Henderson, NV 89014.","Lot #: a) Furosemide PF-10 mg-10 mL: 20130201-F, Exp 5/1/2013; b) Furosemide PF-10 mg-2 mL SDV: 20130306-F, Exp 6/6/2013. ",,"227 vials","Lack of Assurance of Sterility: all sterile products compounded, repackaged, and distributed by this compounding pharmacy due to lack of sterility assurance and concerns associated with the quality control processes.",4/10/2013,"04/10/2013",5/22/2013,"05/22/2013"
"Drugs",64879,"Ongoing","FVS Holdings, Inc. dba. Green Valley Drugs","Henderson","NV","US","Voluntary: Firm Initiated","Press Release","Nationwide","D-364-2013","Class II","Estradiol Cypionate Injection, all strengths and all presentations including a) Estradiol Cypionate 5 mg/mL 10 mL and b) Estradiol Cypionate 10 mg/mL 10 ml, Rx only, Green Valley Drugs, 1850 Whitney Mesa, #180, Henderson, NV 89014.","Lot #: 20130226-F, Exp 5/26/2013; 20130117-K, Exp 4/17/2013 ",,"48 vials","Lack of Assurance of Sterility: all sterile products compounded, repackaged, and distributed by this compounding pharmacy due to lack of sterility assurance and concerns associated with the quality control processes.",4/10/2013,"04/10/2013",5/22/2013,"05/22/2013"
"Drugs",64879,"Ongoing","FVS Holdings, Inc. dba. Green Valley Drugs","Henderson","NV","US","Voluntary: Firm Initiated","Press Release","Nationwide","D-406-2013","Class II","Nandrolone Decanoate and Testosterone Cypionate Injection, all strengths and all presentations including a) Nandrolone 100 mg/mL TestCyp 100 mg/mL 10 mL and b) Nandrolone 100 mg/mL TestCyp 200 mg/mL 10 mL, Rx only, Green Valley Drugs, 1850 Whitney Mesa, #180, Henderson, NV 89014.","Lot #: a) Nandrolone 100 mg/mL TestCyp 100 mg/mL 10 mL: 130220060AE, Exp 5/20/13",,"5 vials","Lack of Assurance of Sterility: all sterile products compounded, repackaged, and distributed by this compounding pharmacy due to lack of sterility assurance and concerns associated with the quality control processes.",4/10/2013,"04/10/2013",5/22/2013,"05/22/2013"
"Drugs",64879,"Ongoing","FVS Holdings, Inc. dba. Green Valley Drugs","Henderson","NV","US","Voluntary: Firm Initiated","Press Release","Nationwide","D-401-2013","Class II","Procaine Hydrochloride Injection, all strengths and all presentations, including a) Procaine 2% 30 mL PF, b) Procaine HCl 2% 10 mL, c) Procaine HCl 20 mg/mL 30 mL, d) Procaine HCl 1% 50 mL MDV, e) Procaine HCl 1% PF 5 mL, 30 mL, Rx only, Green Valley Drugs, 1850 Whitney Mesa, #180, Henderson, NV 89014.","Lot #: a) 20130405-B, Exp 7/5/2013",,"70 vials","Lack of Assurance of Sterility: all sterile products compounded, repackaged, and distributed by this compounding pharmacy due to lack of sterility assurance and concerns associated with the quality control processes.",4/10/2013,"04/10/2013",5/22/2013,"05/22/2013"
"Drugs",64879,"Ongoing","FVS Holdings, Inc. dba. Green Valley Drugs","Henderson","NV","US","Voluntary: Firm Initiated","Press Release","Nationwide","D-379-2013","Class II","Lidocaine Injection, all strengths and all presentations including a) Lidocaine _HCl-0.5%, b) Lidocaine HCl, c) Lidocaine 1%, d) Lidocaine 1% 50 mL, e) Lidocaine 2 %, f) Lidocaine 2% 50 mL, g) Lidocaine 2% 50 mL MDV, Rx only, Green Valley Drugs, 1850 Whitney Mesa, #180, Henderson, NV 89014.","Lot #: a) Lidocaine _HCl-0.5%: 20130403-J, 20130403-F, 20130403-H, 20130403-G, 20130403-I, Exp 7/3/2013; 2013117-I, Exp 4/17/2013; b) Lidocaine HCl: 20130131-H, Exp 4/30/2013; c) Lidocaine 1%: 20130204-N, Exp 5/4/2013; 20130115-A, Exp 4/15/2013; 20130128-E, Exp 4/28/2013; 20130220-G, Exp 5/20/2013; 20130221-J, Exp 5/21/2013; 20130221-K, Exp 5/21/2013; 20130204-J, Exp 5/4/2013; 20130315-J, Exp 6/15/2013; 20130315-K, Exp 6/15/2013; 20130328-E, Exp 6/28/2013; 20130328-H, Exp 6/28/2013; 20130328-I, Exp 6/28/2013; 20130328-K, Exp 6/28/2013; 20130329-B, Exp 6/29/2013; 20130329-C, Exp 6/29/2013; 20130304-K, Exp 6/4/2013; 20130304-L, Exp 6/4/2013; 20130305-L, Exp 6/5/2013; 20130305-D, Exp 6/5/2013; 20130306-H, Exp 6/6/2013; 20130306-P, Exp 6/6/2013; 20130307-J, Exp 6/7/2013; 20130115-B, Exp 4/15/2013; 20130201-M, Exp 5/1/2013; 20130214-A, Exp 5/14/2013; 20130204-M, Exp 5/4/2013; 20130328-F, Exp 6/28/2013; 20130329-A, Exp 6/29/2013; 20130305-M, Exp 6/5/2013; 20130305-D, Exp 6/5/2013; 20130328-J, Exp 6/28/2013; d) Lidocaine 1% 50 ml: 20130128-D, 4/28/2013; 20130115-D, Exp 4/15/2013; 20130115-F, Exp 4/15/2013; 20130117-H, Exp 4/17/2013; 20130115-C, Exp 4/15/2013; e) Lidocaine 2 %: 20130325-F, Exp 6/25/2013; 20130130-N, Exp 4/30/2013; 20130221-L, Exp 5/21/2013; 20130221-N, Exp 5/21/2013; 20130228-I, Exp 5/28/2013; 20130314-H, Exp 6/14/2013; 20130314-I, Exp 6/14/2013; 20130315-E, Exp 6/15/2013; 20130315-F, Exp 6/15/2013; 20130318-K, Exp 6/18/2013; 20130320-D, Exp 6/20/2013; 20130320-B, Exp 6/20/2013; 0130328-D, Exp 6/28/2013; 20130328-G, Exp 6/28/2013; 20130305-E, Exp 6/5/2013; 20130130-M, Exp 4/30/2013; 20130221-M, Exp 5/21/2013; 20130221-O, Exp 5/21/2013; 20130325-E, Exp 6/25/2013; f) Lidocaine 2% 50ml: 20130320-C, Exp 6/20/2013; 20130305-F, Exp 6/5/2013; 20130305-I, Exp 6/5/2013; 20130301-A, Exp 6/1/2013; 20130304-L, Exp 6/4/2013; g) Lidocaine 2% 50ml MDV: 20130227-E, Exp 5/27/2013 ",,"3946 vials","Lack of Assurance of Sterility: all sterile products compounded, repackaged, and distributed by this compounding pharmacy due to lack of sterility assurance and concerns associated with the quality control processes.",4/10/2013,"04/10/2013",5/22/2013,"05/22/2013"
"Drugs",64879,"Ongoing","FVS Holdings, Inc. dba. Green Valley Drugs","Henderson","NV","US","Voluntary: Firm Initiated","Press Release","Nationwide","D-402-2013","Class II","Progesterone Injection, all strengths and all presentations including a) Progesterone 100 mg/mL 10 mL, 30 mL b) Progesterone 50 mg/mL 30 mL, Rx only, Green Valley Drugs, 1850 Whitney Mesa, #180, Henderson, NV 89014.","Lot #: a) Progesterone 100 mg/mL 10 mL: 20130306-E, Exp 6/6/2013",,"13 vials","Lack of Assurance of Sterility: all sterile products compounded, repackaged, and distributed by this compounding pharmacy due to lack of sterility assurance and concerns associated with the quality control processes.",4/10/2013,"04/10/2013",5/22/2013,"05/22/2013"
"Drugs",64879,"Ongoing","FVS Holdings, Inc. dba. Green Valley Drugs","Henderson","NV","US","Voluntary: Firm Initiated","Press Release","Nationwide","D-389-2013","Class II","Methylprednisolone and Dexamethasone Injection, all strengths and all presentations including a) Methylpred/ Dexameth 1-2-3 mL and b) Methylpred/Dexa 3 mL PFS; Rx only, Green Valley Drugs, 1850 Whitney Mesa, #180, Henderson, NV 89014.","Lot #: a) Methylpred/ Dexameth 1-2-3 mL: 13040150GV1, Exp 7/1/2013; 13032750GV3, Exp 6/27/2013; b) Methylpred/Dexa 3 mL PFS: 13032050GV4, Exp 6/20/2013 ",,"430 vials and syringes","Lack of Assurance of Sterility: all sterile products compounded, repackaged, and distributed by this compounding pharmacy due to lack of sterility assurance and concerns associated with the quality control processes.",4/10/2013,"04/10/2013",5/22/2013,"05/22/2013"
"Drugs",64879,"Ongoing","FVS Holdings, Inc. dba. Green Valley Drugs","Henderson","NV","US","Voluntary: Firm Initiated","Press Release","Nationwide","D-378-2013","Class II","L-Glutathione Injection, all strengths and all presentations including a) L-Glut-100 mg-30 mL, b) L-Glut-200 mg/30 mL, c) Glutathione 200 mg/ML P.F. 10 mL, d) L-Glutathione-200-30 mL, 30 mL, Rx only, Green Valley Drugs, 1850 Whitney Mesa, #180, Henderson, NV 89014.","Lot #: a) L-Glut-100 mg-30 mL: 20130213-D, Exp 5/13/2013; b) L-Glut-200 mg/30 mL: 20130318-J, Exp 6/18/2013; 20130301-C, Exp 6/1/2013 ; d) L-Glutathione-200-30 mL, 30 mL: 20130205-A 5/5/2013 ",,"430 vials","Lack of Assurance of Sterility: all sterile products compounded, repackaged, and distributed by this compounding pharmacy due to lack of sterility assurance and concerns associated with the quality control processes.",4/10/2013,"04/10/2013",5/22/2013,"05/22/2013"
"Drugs",64879,"Ongoing","FVS Holdings, Inc. dba. Green Valley Drugs","Henderson","NV","US","Voluntary: Firm Initiated","Press Release","Nationwide","D-359-2013","Class II","Dimercapto-propane-sulfonic acid (DMPS) Injection, all strengths and all presentations including a) DMPS 50 mg/5 mL, b) DMPS 50 mg/mL PF 5 mL, c) DMPS Acid 250 mg/5 mL, Rx only, Green Valley Drugs, 1850 Whitney Mesa, #180, Henderson, NV 89014.","Lot #: a) DMPS 50 mg/5 mL: 20130326-F, Exp 6/26/2013; b) DMPS 50 mg/mL PF 5 mL: 20130311-A, Exp 6/11/2013; c) DMPS Acid 250 mg/5 mL: 20130130-K, Exp 4/30/2013; 20130212-C, Exp 5/12/2013; 20130311-A, Exp 6/11/2013; 20130308-M, Exp 6/8/2013; 20130130-E, Exp 4/30/2013 ",,"251 vials","Lack of Assurance of Sterility: all sterile products compounded, repackaged, and distributed by this compounding pharmacy due to lack of sterility assurance and concerns associated with the quality control processes.",4/10/2013,"04/10/2013",5/22/2013,"05/22/2013"
"Drugs",64879,"Ongoing","FVS Holdings, Inc. dba. Green Valley Drugs","Henderson","NV","US","Voluntary: Firm Initiated","Press Release","Nationwide","D-398-2013","Class II","Phenylephrine Injection, all strengths and all presentations including Phenylephrine 1% 30 mL, Rx only, Green Valley Drugs, 1850 Whitney Mesa, #180, Henderson, NV 89014.","Lot #: 20130129-F, Exp 4/29/2013",,"54 vials","Lack of Assurance of Sterility: all sterile products compounded, repackaged, and distributed by this compounding pharmacy due to lack of sterility assurance and concerns associated with the quality control processes.",4/10/2013,"04/10/2013",5/22/2013,"05/22/2013"
"Biologics",64880,"Terminated","Inland Northwest Blood Center","Spokane","WA","US","Voluntary: Firm Initiated","Telephone","ID","B-1645-13","Class II","Platelets Pheresis Leukocytes Reduced Irradiated","W0685132003619 ",".","1 unit","Blood product, which did not meet the acceptable product specifications for release, was distributed.",3/5/2013,"03/05/2013",7/10/2013,"07/10/2013"
"Biologics",64881,"Terminated","The Blood Connection, Inc.","Piedmont","SC","US","Voluntary: Firm Initiated","Telephone","SC","B-1643-13","Class II","Red Blood Cells Leukocytes Reduced","W121612171658",".","1 unit","Blood product, collected from a donor whose suitability to donate was not adequately determined, was distributed",3/20/2013,"03/20/2013",7/10/2013,"07/10/2013"
"Biologics",64882,"Terminated","Medic Inc","Knoxville","TN","US","Voluntary: Firm Initiated","Telephone","TN","B-1642-13","Class II","Red Blood Cells Leukocytes Reduced","W071213002861; W071212051756 ",".","2 units","Blood products, collected from a donor who had traveled to a malarial endemic area, were distributed.",3/5/2013,"03/05/2013",7/10/2013,"07/10/2013"
"Devices",64883,"Ongoing","Becton Dickinson & Co.","Sparks","MD","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Worldwide Distribution-USA (nationwide) including Puerto Rico, Virgin Islands, and Guam and the countries of Columbia, Japan, Singapore, Canada, Turks, Calicos Islands.","Z-1333-2013","Class II","BBL(tm) Trypticase (tm) Soy Agar with 5% Sheep Blood and MacConkey II-I Plate. Used for culturing microorganisms. ","Model number 221291: lot 2355138 with expiration date 3/6/13, lot 2355164 with expiration date 3/8/13",,"521,160 total pieces (all three recalled products)","Microbiological media may be contaminated with bacteria.",3/11/2013,"03/11/2013",5/22/2013,"05/22/2013"
"Devices",64883,"Ongoing","Becton Dickinson & Co.","Sparks","MD","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Worldwide Distribution-USA (nationwide) including Puerto Rico, Virgin Islands, and Guam and the countries of Columbia, Japan, Singapore, Canada, Turks, Calicos Islands.","Z-1332-2013","Class II","BBL(tm) Trypticase (tm) Soy Agar with 5% Sheep Blood. Used for culturing microorganisms. ","Model number 221239: lot 2348199 with expiration date 4/5/13; and model number 221261: lot 2348208 with expiration date 3/22/13, lot 2355145 with expiration date 4/2/13, lot 2339019 with expiration date 4/5/13, lot 2348157 with expiration date 4/6/13, lot 2361011 with expiration date 4/6/13, lot 2348202 ,with expiration date 4/6/13, lot 2348108 with expiration date 4/12/13, lot 2348074 with expiration date 4/19/13, and lot 3038371 with expiration date 5/28/13",,"521,160 total pieces (all three recalled products)","Microbiological media may be contaminated with bacteria.",3/11/2013,"03/11/2013",5/22/2013,"05/22/2013"
"Devices",64883,"Ongoing","Becton Dickinson & Co.","Sparks","MD","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Worldwide Distribution-USA (nationwide) including Puerto Rico, Virgin Islands, and Guam and the countries of Columbia, Japan, Singapore, Canada, Turks, Calicos Islands.","Z-1334-2013","Class II","BBL(tm) CDC Anaerobe 5% Sheep Blood Agar. Used for culturing microorganisms. ","Model number 221733: lot 2361003 with expiration date 3/14/13",,"521,160 total pieces (all three recalled products)","Microbiological media may be contaminated with bacteria.",3/11/2013,"03/11/2013",5/22/2013,"05/22/2013"
"Devices",64884,"Completed","GE Healthcare, LLC","Waukesha","WI","US","Voluntary: Firm Initiated","Visit","Worldwide Distribution - Nationwide Distribution including the states of FL, IL, IN, LA, MI, MN, NJ, NM, NY, OH, PR, SC, TX and VA and the countries of Vietnam, Latvia, Italy, Israel, Indonesia, Hong Kong, United Kingdom, Finland, Spain, Czech Republic, Canada, Bahrain and Australia.","Z-1142-2013","Class II","GE Healthcare, Innova 2100IQ, Innova 3100IQ, Innova 4100IQ, Cardiovascular and Interventional Imaging System. ","Serial Number 00000000321WVO 00000000353WV3 00000000000000 00000000346WV7 00000000292WW3 00000000327WV7 00000000333WV5 00000000325WV1 00000000298WV0 00000000301WV2 00000000271WV7 00000000250WV1 00000000251WV9 00000000332WV7 00000000263WV4 00000000275WV8 00000000335WV0 00000000249WV3 00000000303WV8 00000000331WV9 00000000255WV0 00000000337WV6 00000000359WV0 00000000362WV4 00000000352WV5 00000000318WV6 00000000324WV4 00000000355WV8 00000000354WV1 00000000329WV3 00000000274WV1 00000000267WV5 00000000305WV3 00000000322WV8 00000000317WV8 00000000132WV1 00000000280WV8 00000000026WV5 00000000254WV3 00000000420WV0 00000000297WV2 00000XXX299WV8 00000000257WV6 00000000357WV4 00000000253WV5 00000000339WV2 00000000265WV9 00000000252WV7 ",".","48","As part of GE Innova IQ table introduction, a label was designed to be affixed on the front Cover of the Gantry Pivot section. This safety label is missing on systems manufactured between March 2010 and July 2011. In the situation a staff member (doctor, nurse, operator, anesthetist, etc&) stands in the region between the C-arm gantry pivot and the head section of the table, there is a risk of collision or jam when the head section of the table moves toward the C-arm gantry pivot. To date no collision or injury has been reported related to this condition.",10/21/2011,"10/21/2011",4/24/2013,"04/24/2013"
"Devices",64885,"Ongoing","GE Healthcare, LLC","Waukesha","WI","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution - USA including AL, CA, CO, FL, ID, IL, MA, NH, NJ, NY, OH, PA, SC, SD, TN, TX, UT, VA, WA, WI; Worldwide: Argentina, Australia, Austria, Brazil, Canada, Chile, Denmark, Egypt, Finland, Germany, India, Italy, Japan, Korea, Malaysia, Netherlands, Norway, Peru, Poland, Russia, Singapore, South Africa, Spain, Sweeden, Switzerland, UK, Ukraine, and UAE.","Z-1211-2013","Class II","MSK EXTREME MR SCANNER, MODEL AA5000 The intended for use as a diagnostic imaging device to produce axial, sagittal, coronal and oblique images of the internal structures of the leg (excluding the thigh), knee, ankle, foot, forearm, elbow, wrist and hand.","01072011-001; 01082010-001; 01182010-001; 01182011-001; 01272010-001; 02032011-001; 02112010-001; 02182011-001; 02242010-001; 2262011-001; 03012010-001; 03072010-001; 03132009-001; 03242009-001; 03292011-001; 03302011-001; 04012010-001; 04082010-001; 04192011-001; 04202011-001; 04302010-001; 05072010-001; 05132011-001; 05152009-001; 05242010-001; 05262010-001; 06012008-001; 06042009-001; 06062009-001; 06082010-001; 06182010-001; 06192009-001; 07082010-001; 07092010-001; 07142009-001; 07152011-001; 07272010-001; 08082009-001; 08122009-001; 08122010-001; 08132009-001; 08152010-001; 09072009-001; 09132010-001; 09142010-001; 09172009-001; 09222009-001; 09222010-001; 10012009-001; 10082009-001; 10082010-001; 10142009-001; 10182010-001; 10222010-001; 10252009-001; 10312010-001; 11162010-001; 11242009-001; 11292010-001; 12052010-001; 12072009-001; 12142009-001; 12152009-001; 12162008-001; 12182008-001; 12222010-001 ",,"70","Coolant supply lines may leak liquid onto the floor resulting in a slippery surface and fall hazard. ",3/28/2013,"03/28/2013",5/8/2013,"05/08/2013"
"Devices",64885,"Ongoing","GE Healthcare, LLC","Waukesha","WI","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution - USA including AL, CA, CO, FL, ID, IL, MA, NH, NJ, NY, OH, PA, SC, SD, TN, TX, UT, VA, WA, WI; Worldwide: Argentina, Australia, Austria, Brazil, Canada, Chile, Denmark, Egypt, Finland, Germany, India, Italy, Japan, Korea, Malaysia, Netherlands, Norway, Peru, Poland, Russia, Singapore, South Africa, Spain, Sweeden, Switzerland, UK, Ukraine, and UAE.","Z-1212-2013","Class II","Optima MR430s MRI Scanner; 5000-0002 is indicated to use as a magnetic resonance imaging device of the leg (excluding the thigh), knee, ankle, foot, elbow, forearm, wrist, and hand.","08022011-001; 09092011-001;12102011-001;05152012-004;SM11062012-001;02022012-001;08142012-001;04212012-001;05252012-002;12132011-001;SM08292012-007;11052011-002;01192012-001;01132012-001;06282012-010;07252012-001;01022012-001;11202011-001;08142011-001;06302011-001;09172011-001;10082011-001;10172011-002;03142012-007;06142012-001;06212012-001;07172012-001;07232012-001;SM09132012-003;02042012-001;01132012-001;07172011-001;09062011-001;09242011-001;SM10122012-003;M12102012-003;05102012-004;08022012-003;07302012-008;SM01072013-005;05032012-004;08032012-001;10172011-001;SM08152012-001;12262011-001;10092011-001;04172012-001;11052011-001;07112011-001;10242011-007;07222011-001;08102011-001;03092012-001;05172011-001;06222011-001;03202012-004;05182012-001;07112012-002;06092011-001;01232012-001;02162012-001;11262012-007;SM12172012-001;01212012-001;SM10232012-001;11212011-001;12222011-001;SM11132012-002;06012011-001;07132011-001;12042011-001;03062012-007;03282012-001;10272011-009;12142011-001;10302012-006;02112012-001;03062012-008;01272012-001;05162012-003;03262012-002;11292011-001;06112012-004;10172012-001;12102012-001 ",,"81","Coolant supply lines may leak liquid onto the floor resulting in a slippery surface and fall hazard. ",3/28/2013,"03/28/2013",5/8/2013,"05/08/2013"
"Devices",64886,"Ongoing","The Anspach Effort, Inc.","Palm Beach Gardens","FL","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution-USA (nationwide) including DC and the states of OH, TX, IL, CA, GA, KY, FL, WI, NC, VA, WI, MN, MD, KS, OK, PA, OR ,HI, AZ, WA, TN, AR, IA, MI, CO, LA, NJ, IN, WV, MO, AL, NY, VT, and SC and the countries of France, Canada, Great Britain, Mexico, Australia, Sweden and Netherlands.","Z-1377-2013","Class II","***REF S-3D*** 3mm Diamond Ball. Used for cutting and shaping bone. ","Lots numbers: D433040800, D403040236, D383039472. ",".","1,827 burrs","Due to three batches of product may have diamond grit size larger than intended applied to the head of the cutting burr.",3/4/2011,"03/04/2011",6/5/2013,"06/05/2013"
"Devices",64887,"Ongoing","Insight Instruments, Inc.","Stuart","FL","US","Voluntary: Firm Initiated","Letter","US Distribution IN and IL","Z-1281-2013","Class II"," Insight Instruments MIS ( Multi-Port Illumination System) Illuminated pilot tubes work like a ceiling light while simultaneously protecting the entry sites. Illumination automatically follows the movement of the two surgical instruments inserted into the M.I.S. cannulas. The large distance of more than 16mm between cannula ends and posterior pole guarantees sufficient light in the working area and a large observation field especially when used in conjunction with modern wide field panoramic observation systems.","Lot Numbers: M53157, M55115, M56929, M58551, M61862.",,"776","Insight Instruments, Inc., Stuart, FL is recalling M.I.S. (Multi-Port Illumination System), Ophthalmic Cannula due to a misclassification of the medical device.",3/15/2013,"03/15/2013",5/22/2013,"05/22/2013"
"Devices",64888,"Ongoing","Clorox Healthcare Holdings, LLC (dba HealthLink)","Jacksonville","FL","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution-USA (nationwide) including Puerto Rico and the states of AZ, CA, CO, FL, GA, IA, IL, IN, MI, MO, MS, MT, NC, NJ, NY, OH, SC,TX ,VA ,WA, WI, and HI, and the countries of Canada, Mexico, and New Zealand.","Z-1655-2013","Class II","PSS Select medical products***Biopsy Punches*** Disposable manual instrument for skin biopsy.","1103316, 1100626, 1100625, 1100624, 1100623, 1100622, 1100621, 1100620, 1100619, 1100618, 1100617, 1100616, 1100615, 1100318, 1100317, 1100316, 1034725, 1034724, 1033414, 1031515, 1028733, 1028732, 1028723, 1028722, 1028721, 1028720, 1028719, 1028718, 1028717, 1028716, 1028715, 1028721, 1028722, 1028723, 1028706, 1028707, 1023914, 1023913, 1023912, 1023910, 1023908, 1023907, 1023904, 1023903, 1023902, 1023901, 1023114, 1023111, 1023110, 1023107, 1023106, 1023110, 1023111, 1023112, 1023113, 1023114, 1023115, 1023116, 1023117, 1023118, 1023119, 1023120, 1023121, 1023122, 1019605, 1019606, 1019607, 1019608, 1019609, 1019610, 1019615, 1019616, 1019617, 1019618, 1019619, 1015217, 1015216, 1015215, 1013315, 1013219, 1001861, 1001860, 1001859, 1001858, 1001857, 1001856, 1001854, 1001852, 1001851, 1001850, 1001849, 1001848, 1001847, 1001846, 1001845, 1001843, 1001842, 1001841, 1000527, 1000526, 1000525, 1000518, 0935203, 0935202, 0935201, 0934418, 0931016, 0931015, 0931013, 0931012, 0931011, 0931009, 0931008, 0931007, 0931006, 0931005, 0931004, 0930216, 0930215, 0930214, 0930213, 0927931, 0927930, 0927929, 0927928, 0927927, 0927926, 0927924, 0927923, 0927922, 0927921, 0927920, 0927919, 0927128, 0927127, 0927126, 0927125, 0927124, 0927123, 0927122, 0927121, 0927120, 0926021, 0926020, 0926019, 0926018, 0926017, 0926016, 0926015, 0923116, 0923019, 0923018, 0923017, 0922516, 0922515, 0921533, 0921532, 0921529, 0921526, 0921525, 0921524, 0921523, 0921523, 0921522, 0921517, 0919724, 0919723, 0919722, 0919720, 0919719, 0919718, 0919715, 0919714, 0919713, 0919712, 0919711, 0917612, 0917321, 0917320, 0917319, 0917318, 0917316, 0916228, 0916227, 0916225, 0916223, 0916221, 0916219, 0914718, 0914717, 0914716, 0914715, 0913326, 0913324, 0913323, 0913322, 0913321, 0911413, 0911412, 0911410, 0911408, 0911403, 0911401, 0909922, 0909920, 0909918, 0909913, 0907901, 0907819, 0907720, 0907719, 0907618, 0905824, 0905821, 0905820, 0905819, 0905818, 0905815, 0905814, 0905813, 0905812, 0905807, 0905804, 0905802, 0904319, 0903522, 0901335, 09",".","1,032,700 units","Due to lack of sterilization.",3/18/2013,"03/18/2013",7/10/2013,"07/10/2013"
"Devices",64888,"Ongoing","Clorox Healthcare Holdings, LLC (dba HealthLink)","Jacksonville","FL","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution-USA (nationwide) including Puerto Rico and the states of AZ, CA, CO, FL, GA, IA, IL, IN, MI, MO, MS, MT, NC, NJ, NY, OH, SC,TX ,VA ,WA, WI, and HI, and the countries of Canada, Mexico, and New Zealand.","Z-1654-2013","Class II","HealthLink***BIOPSY PUNCHES*** Disposable manual instrument for skin biopsy.","1232041; 1232030, 1232028, 1232024, 1232021, 1232020, 1232015, 1232013, 1232010, 1232009, 1231324, 1231323, 1226436, 1226435 1226432, 1226421, 1226416, 1226415, 1226416, 1226417, 1226418, 1226419, 1222318, 1222319, 1222320, 1222321, 1222322, 1217409, 1217404, 1213926, 1213924, 1213923, 1213921, 1213918, 1213917, 1213916, 1213910, 1213907, 1213906, 1213905, 1213115, 1208740, 1208739, 1208738, 1208737, 1208736, 1208735, 1208734, 1208733, 1208732, 1208731, 1208730, 1208729, 1205343, 1205342, 1205341, 1205340, 1205339, 1205338, 1205337, 1205336, 1205335, 1205334, 1205333, 1205332, 1205331, 1205330, 1205329, 1203217, 1201930, 1201929, 1201928, 1201927, 1201926, 1134639, 1134638, 1134637, 1134636, 1129331, 1129330, 1129328, 1129327, 1129324, 1125634, 1125633, 1125632, 1125631, 1125630, 1125629, 1125628, 1125627, 1125626, 1125625, 1125624, 1125623, 1123522, 1123521, 1123520, 1123519, 1123517, 1123512, 1122926, 1122925, 1122924, 1122923, 1122922, 1122720, 1121521, 1119218, 1116715, 1116020, 1116019, 1113222, 1113221, 1113220, 1113219, 1113218, 1111812, 1111811, 1111810, 1111809, 1111808, 1111025, 1111024, 1111023, 1111022, 1110130, 1109622, 1109621, 1109620, 1109617, 1109020, 1109019, 1106224, 1106223, 1106222, 1106221, 1106220, 1106219, 1105421, 1105420, 1105419, 1105418, 1105417, 1105416, 1105415, 1104213, 1104212, 1104211, 1103825, 1103824, 1103320, 1103319, 1103318, 1103317, 1102611, 1102610, 1101218, 1035518, 1034723, 1034722, 1034721, 1034720, 1034719, 1030620, 1030619, 1030618, 1030617, 1030616, 1030615, 1028731, 1028730, 1028729, 1028728, 1028727, 1028726, 1028725, 1028724, 1028716, 1028717, 1028718, 1028719, 1028720, 1027217, 1027216, 1023916, 1023915, 1023911, 1023909, 1023906, 1023905, 1023113, 1023112, 1023109, 1023108, 1023107, 1023108, 1023109, 1019602, 1019603, 1019604, 1019611, 1019612, 1019613, 1019614, 1015220, 1015219, 1015218, 1013316, 1013220, 1013218, 1009814, 1001855, 1001853, 1001844, 1001840, 1001839, 1001838, 1001837, 1001836, 1001835, 1001834, 1001833, 1001832, ",".","1,044,600 units","Due to lack of sterilization.",3/18/2013,"03/18/2013",7/10/2013,"07/10/2013"
"Devices",64888,"Ongoing","Clorox Healthcare Holdings, LLC (dba HealthLink)","Jacksonville","FL","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution-USA (nationwide) including Puerto Rico and the states of AZ, CA, CO, FL, GA, IA, IL, IN, MI, MO, MS, MT, NC, NJ, NY, OH, SC,TX ,VA ,WA, WI, and HI, and the countries of Canada, Mexico, and New Zealand.","Z-1656-2013","Class II","ARGENT SURGICAL SYSTEMS***BIOPSY Punches*** Disposable manual instrument for skin biopsy.","1232040, 1232039, 1232038, 1232037, 1232029, 1232027, 1232026, 1232025, 1232023, 1232022, 1232019, 1232018, 1232017, 1232016, 1232014, 1232012, 1232011, 1232008, 1232007, 1232006, 1231322, 1231321, 1231320, 1231315, 1226439, 1226438, 1226434, 1226433, 1226431, 1226430, 1226429, 1226428, 1226427, 1226426, 1226422, 1226420, 1226419, 1226418, 1226417, 1226415, 1226414, 1222301, 1222302, 1222303, 1222304, 1222305, 1222306, 1222307, 1222308, 1222309, 1222310, 1222311, 1222312, 1222313, 1222314, 1222315, 1222316, 1222317, 1222323, 1222324, 1222325, 1222326, 1222327, 1222328, 1222329, 1222330, 1222331, 1222332, 1222333, 1222334, 1222335, 1222336, 1222337, 1222338, 1222339, 1222001, 1217408, 1217407, 1217406, 1217405, 1217403, 1217402, 1217401, 1214505, 1213925, 1213922, 1213920, 1213919, 1213915, 1213914, 1213913, 1213912, 1213911, 1213909, 1213908, 1213904, 1213903, 1213902, 1213901, 1211614, 1211613, 1208728, 1208727, 1208726, 1208725, 1208724, 1208723, 1208722, 1208721, 1208720, 1207323, 1205328, 1205327, 1205326, 1205325, 1205324, 1205323, 1205322, 1205321, 1205320, 1205319, 1205318, 1205317, 1205316, 1205315, 1201925, 1201924, 1201923, 1201922, 1201921, 1201920, 1201919, 1201918, 1201917, 1201916, 1201915, 1201914, 1201913, 1201912, 1201911, 1201910, 1201909, 1200511, 1200319, 1134635, 1134634, 1134633, 1134632, 1134631, 1134630, 1134629, 1134628, 1134627, 1134626, 1134625, 1134624, 1129718, 1129329, 1129326, 1129325, 1129323, 1129322, 1129321, 1129320, 1129319, 1129318, 1129317, 1129316, 1129315, 1129314, 1128318, 1125622, 1125621, 1125620, 1125619, 1125618, 1125617, 1125616, 1125615, 1123516, 1123515, 1123514, 1123010, 1122921, 1122920, 1122919, 1122918, 1122917, 1122916, 1122915, 1122719, 1122718, 1122717, 1122716, 1121520, 1121519, 1121518, 1121517, 1121516, 1121515, 1120814, 1120727, 1120726, 1120725, 1120724, 1120723, 1120722, 1120721, 1120720, 1119923, 1119922, 1119921, 1119920, 1119919, 1119324, 1119323, 1119322, 1119321, 1119320, 1119319, 1118723, 1118722, 1118721, 1118720, ",".","772,600 units","Due to lack of sterilization.",3/18/2013,"03/18/2013",7/10/2013,"07/10/2013"
"Devices",64889,"Completed","GE Healthcare, LLC","Waukesha","WI","US","Voluntary: Firm Initiated","Visit","Worldwide Distribution-USA (nationwide) including DC and the states of AZ, CA, CO, CT, FL,GA, IL, IN, KY, MA, MI, MS,MO, NH, NJ, NM, NY, NC, OK, OR, PA, SC, SD, TX, UT, VA, WA, and WI and the countries of ALBANIA ARGENTINA AUSTRALIA BELGIUM BRAZIL CANADA CHINA COLOMBIA COSTA RICA CZECH REPUBLIC DENMARK ECUADOR EGYPT FINLAND FRANCE GREECE HONG KONG HUNGARY INDIA IRELAND ITALY JAPAN KOREA, REPUBLIC OF MEXICO MOROCCO NIGERIA NORWAY POLAND RUSSIAN FEDERATION SINGAPORE SPAIN SWEDEN SWITZERLAND TURKEY UKRAINE UNITED KINGDOM.","Z-1188-2013","Class II","GE, VCT for Discovery VCT, Discovery RX VCT, and Discovery PET/CT 690, Lightspeed VCT, Discovery CT750HD. Intended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission. ","Serial Number 00000416307CN7 00000416534CN6 00000418451CN1 00000416467CN9 00000414273CN3 00000416594CN0 00000416589CN0 00000416532CN0 00000417617CN8 00000416889CN4 00000416685CN6 00000418151CN7 00000416332CN5 00000416591CN6 00000416468CN7 00000416333CN3 00000419445CN2 00000416269CN9 00000416815CN9 00000416117CN0 00000416524CN7 00000416267CN3 00000419240CN7 00000416646CN8 00000417864CN6 00000416195CN6 00000419505CN3 00000418001CN4 00000416816CN7 00000416551CN0 00000416201CN2 00000417625CN1 00000417650CN9 00000416220CN2 00000419411CN4 00000416390CN3 00000418913CN0 00000416737CN5 00000416738CN3 00000416777CN1 00000416363CN0 00000416888CN6 00000416590CN8 00000417177CN3 00000419041CN9 00000416850CN6 00000416627CN8 00000417275CN5 00000417709CN3 00000417133CN6 00000419446CN0 00000419375CN1 00000418807CN4 00000418035CN2 00000418238CN2 00000418843CN9 00000417786CN1 00000419393CN4 00000417695CN4 00000419507CN9 00000419078CN1 00000419280CN3 00000419390CN0 00000419526CN9 00000419525CN1 00000419559CN0 00000418819CN9 00000419506CN1 00000418402CN4 00000419089CN8 00000419550CN9 00000416736CN7 00000418656CN5 00000416781CN3 00000416798CN7 00000418357CN0 00000419447CN8 00000416552CN8 00000418810CN8 00000416764CN9 00000419178CN9 00000417719CN2 00000416389CN5 00000418514CN6 00000417634CN3 00000416848CN0 00000417733CN3 00000417716CN8 00000416849CN8 00000417649CN1 00000416286CN3 00000416401CN8 00000418847CN0 00000419177CN1 00000416533CN8 00000417644CN2 00000419376CN9 00000419504CN6 00000416231CN9 00000416301CN0 00000417626CN9 00000418403CN2 00000419079CN9 00000416268CN1 00000416620CN3 00000416597CN3 00000416763CN1 00000418780CN3 00000417643CN4 00000416647CN6 00000417642CN6 00000418791CN0 00000416466CN1 00000416388CN7 00000416353CN1 00000417134CN4 00000419241CN5 00000418915CN5 00000419174CN8 00000418818CN1 00000416295CN4 00000417720CN0 00000418846CN2 00000416372CN1 00000416762CN3 00000417714CN3 00000416882CN9 ",,"166","Fastener bolts on the heat exchanger were not properly torqued and part of the heat exchanger can detach from the gantry and hit the inside of the covers and other components of the gantry possibly resulting in the oil conduit breaking, spilling oil within the gantry and outside the system. This issue affects GE Healthcare VCT for Discovery VCT, Discovery RX VCT, and Discovery PET/CT 690, Lightspeed VCT, Discovery CT750HD.",7/25/2011,"07/25/2011",5/8/2013,"05/08/2013"
"Biologics",64890,"Ongoing","Terumo Bct","Lakewood","CO","US","Voluntary: Firm Initiated","Letter","National and global distribution.","B-1670-13","Class II","Trima Accel Automated Blood Component Collection System, catalog number 81000, all serial numbers, with software versions prior to 5.1.9 and 6.0.6.","Catalog number 81000, ALL SERIAL NUMBERS.",".","3074 units","Terumo BCT's Trima Accel systems, with a potential risk for an air embolism should a donor be prematurely connected to the Trima Accel system, were distributed. ",4/12/2013,"04/12/2013",6/19/2013,"06/19/2013"
"Biologics",64891,"Terminated","Penrose-St Francis Health Services Blood Bank","Colorado Springs","CO","US","Voluntary: Firm Initiated","Telephone","CO","B-1641-13","Class II","Red Blood Cells Leukocytes Reduced","W290613050045",".","1 unit","Blood product, collected from a donor who traveled to a malarial endemic area, was distributed. ",4/10/2013,"04/10/2013",7/10/2013,"07/10/2013"
"Biologics",64892,"Terminated","Penrose-St Francis Health Services Blood Bank","Colorado Springs","CO","US","Voluntary: Firm Initiated","Telephone","CO","B-1640-13","Class II","Red Blood Cells Leukocytes Reduced","W290613050044",".","1 unit","Blood product, collected from a donor who traveled to a malarial endemic area, was distributed",4/10/2013,"04/10/2013",7/10/2013,"07/10/2013"
"Biologics",64893,"Terminated","LifeSouth Community Blood Centers, Inc.","Dunwoody","GA","US","Voluntary: Firm Initiated","FAX","GA","B-1639-13","Class II","Platelets Pheresis Leukocytes Reduced","W115113051972Y",".","1 unit","Blood product, with a low platelet count, was distributed.",2/24/2013,"02/24/2013",7/10/2013,"07/10/2013"
"Biologics",64895,"Terminated","American National Red Cross (the)","Charlotte","NC","US","Voluntary: Firm Initiated","FAX","NC","B-1638-13","Class II","Red Blood Cells Leukocytes Reduced","012KV39786",".","1 unit","Blood products, which were not quarantined subsequent to receiving post donation information, were distributed. ",2/11/2013,"02/11/2013",7/10/2013,"07/10/2013"
"Biologics",64895,"Terminated","American National Red Cross (the)","Charlotte","NC","US","Voluntary: Firm Initiated","FAX","NC","B-1637-13","Class II","Plasma Frozen within 24 hours (FP24)","012KV39786",".","1 unit","Blood products, which were not quarantined subsequent to receiving post donation information, were distributed. ",2/11/2013,"02/11/2013",7/10/2013,"07/10/2013"
"Food",64896,"Ongoing","Wegmans Food Markets","Rochester","NY","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","NY, NJ, PA, VA, MD & MA","F-1366-2013","Class I","Wegmans Food You Feel Good About Roasted Red Pepper Dip, Net Wt 8 oz. (227g) Product is packaged in plastic containers, 12 containers per case. UPC: 77890 23286 with a best-by date of 5/17/2013. Commodity Code: 23286, Item #: DIPWG23286","expiration date 5/17/13, Lot# 13081",,"1,110 units (81 cases)","Wegmans Foods Markets issued a Press Release on April 16, 2013 and is recalling affected units of Roasted Red Pepper Dip because some of the tubs may have an incorrect ingredient label that does not list milk and eggs.",4/16/2013,"04/16/2013",5/8/2013,"05/08/2013"
"Food",64897,"Ongoing","Wild Blue Yonder Foods/Waugh","Lynn","MA","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","MA, CT, NJ, PA, NC, SC, FL, MI and TX","F-1347-2013","Class I","Chappaqua Crunch GF(Gluten Free) Simply Granola with Flax & Fruit , 12 ounce pouch UPC: 786516-76002 6","All Best By Dates between 10/01/13 and 11/10/13 ",".","5004 units (834 cases x 6 units)","Product contains undeclared almonds",4/11/2013,"04/11/2013",5/1/2013,"05/01/2013"
"Devices",64898,"Ongoing","Cypress Medical Products LLC","Mchenry","IL","US","Voluntary: Firm Initiated","E-Mail","US Distribution to the state of VA only.","Z-1273-2013","Class II","Cypress Medical Products LLC, MediChoice Umbilical cord clamp, sterile; single use; Distributed by Owens & Minor, Mechanicsville, VA. The product is used to clamp the umbilical cord after childbirth.","Part Number: 1773088101; Lot Number CYB03-11; 1 per pouch; 100 pouches per box.",".","150 Cases (75,000 Units)","Cypress Medical Products LLC is voluntarily recalling one lot of the Owens and Minor (O&M) Umbilical Cord Clamps because recent complaints indicate the clamps are breaking upon use. The product may not perform as intended.",4/15/2013,"04/15/2013",5/15/2013,"05/15/2013"
"Food",64899,"Ongoing","Two Chefs On A Roll, Inc","Carson","CA","US","Voluntary: Firm Initiated","E-Mail","CA, WA, AZ, IL, PA","F-1337-2013","Class II","Trader Joe's Hummus Salad Dressing 12 oz., 12 units/case, SKU 96752. ","Sell By Dates: 05/14/13, 05/18/13, 05/20/13, 05/21/13, 05/22/13, 05/25/13.",".","608 units","Two Chefs on a Roll is recalling humus products because they may contain small pieces of material from food grade equipment.",4/9/2013,"04/09/2013",4/24/2013,"04/24/2013"
"Food",64899,"Ongoing","Two Chefs On A Roll, Inc","Carson","CA","US","Voluntary: Firm Initiated","E-Mail","CA, WA, AZ, IL, PA","F-1331-2013","Class II","Trader Joe's Mediterranean Hummus 16 oz., 12 units/case, SKU 90642. ","Sell By Dates: 04/25/13, 04/29/13, 05/03/13, 05/06/13.",".","4855 units","Two Chefs on a Roll is recalling humus products because they may contain small pieces of material from food grade equipment.",4/9/2013,"04/09/2013",4/24/2013,"04/24/2013"
"Food",64899,"Ongoing","Two Chefs On A Roll, Inc","Carson","CA","US","Voluntary: Firm Initiated","E-Mail","CA, WA, AZ, IL, PA","F-1329-2013","Class II","Trader Joe's Hummus Dip Size: 16 oz., 12 units/case, SKU 20411. Size: 7 oz, 24 units/case, SKU 15735.","16oz Sell By Dates: 04/26/13, 05/01/13, 05/03/13 7oz Sell by date: 05/01/13",".","3269 units","Two Chefs on a Roll is recalling humus products because they may contain small pieces of material from food grade equipment.",4/9/2013,"04/09/2013",4/24/2013,"04/24/2013"
"Food",64899,"Ongoing","Two Chefs On A Roll, Inc","Carson","CA","US","Voluntary: Firm Initiated","E-Mail","CA, WA, AZ, IL, PA","F-1332-2013","Class II","Trader Joe's Spicy Hummus Dip 7 oz., 24 units/case, SKU 38056. ","Sell By Dates: 04/30/13.",".","559 units","Two Chefs on a Roll is recalling humus products because they may contain small pieces of material from food grade equipment.",4/9/2013,"04/09/2013",4/24/2013,"04/24/2013"
"Food",64899,"Ongoing","Two Chefs On A Roll, Inc","Carson","CA","US","Voluntary: Firm Initiated","E-Mail","CA, WA, AZ, IL, PA","F-1330-2013","Class II","Trader Joe's Three Layer Hummus Dip 12 oz., 12 units/case, SKU 80867.","Sell By Dates: 04/22/13, 04/27/13, 04/28/13, 05/02/13.",".","758 units","Two Chefs on a Roll is recalling humus products because they may contain small pieces of material from food grade equipment.",4/9/2013,"04/09/2013",4/24/2013,"04/24/2013"
"Food",64899,"Ongoing","Two Chefs On A Roll, Inc","Carson","CA","US","Voluntary: Firm Initiated","E-Mail","CA, WA, AZ, IL, PA","F-1335-2013","Class II","Trader Joe's Chunky Olive Hummus 7 oz., 24 units/case, SKU 75347. ","Sell By Dates: 04/28/13.",".","377 units","Two Chefs on a Roll is recalling humus products because they may contain small pieces of material from food grade equipment.",4/9/2013,"04/09/2013",4/24/2013,"04/24/2013"
"Food",64899,"Ongoing","Two Chefs On A Roll, Inc","Carson","CA","US","Voluntary: Firm Initiated","E-Mail","CA, WA, AZ, IL, PA","F-1336-2013","Class II","Trader Joe's Mediterranean Hummus Snack Pack with Pita Chips 8 oz., 24 units/case, SKU 97136. ","Sell By Dates: 04/25/13, 04/26/13, 04/29/13, 05/01/13, 05/02/13, 05/03/13, 05/06/13",".","953 units","Two Chefs on a Roll is recalling humus products because they may contain small pieces of material from food grade equipment.",4/9/2013,"04/09/2013",4/24/2013,"04/24/2013"
"Food",64899,"Ongoing","Two Chefs On A Roll, Inc","Carson","CA","US","Voluntary: Firm Initiated","E-Mail","CA, WA, AZ, IL, PA","F-1333-2013","Class II","Trader Joe's Roasted Garlic Hummus Dip 7 oz., 24 units/case, SKU 20648. ","Sell By Dates: 04/26/13, 05/02/13.",".","1349 units","Two Chefs on a Roll is recalling humus products because they may contain small pieces of material from food grade equipment.",4/9/2013,"04/09/2013",4/24/2013,"04/24/2013"
"Food",64899,"Ongoing","Two Chefs On A Roll, Inc","Carson","CA","US","Voluntary: Firm Initiated","E-Mail","CA, WA, AZ, IL, PA","F-1334-2013","Class II","Trader Joe's Tomato Basil Hummus Dip 7 oz., 24 units/case, SKU 21953. ","Sell By Dates: 04/30/13, 05/01/13.",".","497 units","Two Chefs on a Roll is recalling humus products because they may contain small pieces of material from food grade equipment.",4/9/2013,"04/09/2013",4/24/2013,"04/24/2013"
"Devices",64900,"Completed","GE Healthcare, LLC","Waukesha","WI","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution - USA Nationwide including the states of: AK, AZ, CA, CO, CT, DE, DC, FL, GA, HI, IL, IN, IA, LA, MD, MI, ,N, ,S, MO, MT, NJ, NM, NY, NC, OH, OK, PA, SC, SD, TN,TX, UT, VA, WA, WI. and the countries of : AUSTRALIA, AUSTRIA, BELGIUM, BOSNIA, BRAZIL, CANADA, DENMARK, EGYPT, ESTONIA, FINLAND, FRANCE, GERMANY, GREAT BRITAIN, GREECE, GUADELOUPE, HONG KONG, INDIA, ISRAEL, ITALY, JAPAN, KOREA, LIBYA, MALAYSIA, NETHERLANDS, NEW ZEALAND, NORWAY, PANAMA, POLAND, QATAR, REUNION, ROMANIA, RUSSIA, SAUDI ARABIA, SINGAPORE, SOUTH AFRICA, SPAIN, SWEDEN, SWITZERLAND, THAILAND, TURKEY and UNITED ARAB EMIRATES.","Z-1137-2013","Class II","GE Healthcare, AW Server. Product Usage: . AW Server is a medical software system that allows multiple users to remotely access AW applications from compatible computers on a network. The system allows networking, selection, processing and filming of multimodality DICOM images. Both the client and server software are only for use with off the shelf hardware technology that meets defined minimum specifications.","Mfg Lot or Serial # 00000267104GE8 00000276601GE2 00000211976GE6 00000223238GE7 00000257702GE1 00000183554HP5 00000248244GE6 000001010056GS 00000256021GE7 00000240706GE2 00000223235GE3 00000218205GE3 00000216337GE6 00000266111GE4 00000223234GE6 00000276603GE8 00000275004GE0 00000183573HP5 00000183555HP2 00000235884GE4 00000240705GE4 00000222533GE2 00000218207GE9 00000257708GE8 00000275003GE2 00000261642GE3 00000214206GE5 00000214821GE1 00000266112GE2 00000217429GE0 00000240703GE9 00000257707GE0 00000219371GE2 00000235886GE9 00000217427GE4 00000216338GE4 00000183518HP0 00000271798GE1 00000214817GE9 00000216334GE3 00000235885GE1 00000183570HP1 00000216331GE9 00000183568HP5 00000267105GE5 00000217428GE2 00000211978GE2 000001010012GS 00000240704GE7 00000229339GE7 00000216340GE0 00000266110GE6 00000267106GE3 00000260456GE9 00000222536GE5 00000261644GE9 00000214818GE7 00000183562HP8 00000229342GE1 00000276070GE0 00000235883GE6 00000257711GE2 00000257706GE2 00000222535GE7 00000260457GE7 00000246497GE2 00000246500GE3 00000211977GE4 00000261646GE4 00000183557HP8 00000183561HP0 00000213558GE0 00000183558HP6 00000183567HP7 00000223243GE7 00000223240GE3 00000240707GE0 00000216336GE8 00000276602GE0 00000218090GE9 00000L03F0BD38 00000211975GE8 00000276600GE4 00000222534GE0 00000229343GE9 00000219372GE0 00000209172GE6 00000214205GE7 00000261648GE0 00000217426GE6 00000248243GE8 00000223236GE1 00000240708GE8 00000256014GE2 00000213559GE8 00000229341GE3 00000183563HP6 00000183565HP1 00000F11206004 00000B12048002 00000E11026006 0000AB11054001 0000AA11157008 00000E11301005 00000LFB4BA808 00000M11284003 0000AX11314002 00000P10347012 000001010007GS 00000A12038004 0000AX11314001 000001010009GS 000001010008GS 000001010052GS 00000L11074001 00000260454GE4 00000183571HP9 00000218206GE1 00000229344GE7 00000248248GE7 00000267107GE1 00000261643GE1 00000261650GE6 00000257705GE4 00000223239GE5 00000183515HP6 00000183574HP3 00000246496GE4 00000248245GE3 00000261649GE8 00000257710GE4 00000248246GE1 00000217425GE8 00000267109GE7 00000260459GE3 ",".","429","GE Healthcare has recently become aware of a potential safety issue with respect to the Results Viewer in the AW Server. After starting the Results Viewer with the selected series of a patient, the pixel and certain annotation data from a different patient is displayed in one of the viewports. This occurs on an occasional basis, when multiple users are simultaneously accessing the Results Viewer.",6/28/2012,"06/28/2012",4/24/2013,"04/24/2013"
"Devices",64901,"Ongoing","Ortho-Clinical Diagnostics","Rochester","NY","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution - Nationwide including Puerto Rico, and the countries of Australia, Bermuda, Brazil, Canada, Chile, China, Colombia, England, France, Germany, India, Italy, Japan, Mexico, Panama, Singapore, Spain and Venezuela.","Z-1337-2013","Class III","VITROS Immunodiagnostic Products CK-MB Calibrators, REF 128 6293, IVD, Ortho-Clinical Diagnostics High Wycombe HP12 4DP, UK For use in the calibration of the VITROS ECi/ECiQ Immunodiagnostic Systems, the VITROS 3600 Immunodiagnostic System and the VITROS 5600 Integrated System for the quantitative measurement of CK-MB in human serum and plasma (EDTA or heparin). ","Lots 1400 (exp. 22 April 2013), 1410 (exp. 20 May 2013), 1420 (exp. 12 July 2013), 1430 (exp. 5 August 2013) , 1440 (exp. 10 September 2013), 1450 (exp. 18 November 2013), 1460 (exp. 18 November 2013), 1465 (exp. 13 November 2013), 1480 (exp. 3 January 2014)",".","Domestic: 3019 units, Foreign: 905 units","Internal testing demonstrated that opened-reconstituted VITROS CK-MB Calibrators stored at -20 degrees Celsius (-4 degrees Farenheit) generated invalid calibrations that were detected by positively biased quality control results. ",4/3/2013,"04/03/2013",5/29/2013,"05/29/2013"
"Veterinary",64903,"Ongoing","Bimeda MTC Animal Health Inc.","Cambridge",,"CA","Voluntary: Firm Initiated","Letter","Nationwide (KS and WI)","V-193-2013","Class II","Calcium Gluconate 23% Solution; Sterile Preservative Free; FOR ANIMAL USE ONLY; Packaged in HDPE 500 mL bottle with a grey 30mm chlorobutyl rubber (siliconized) stopper and capped with a red tear off aluminum seal.","Lot Number: 2J029A; Item Number: 1CAL028, 500 mL, Bimeda Inc.; Expiry: 14 SEP",".","19,560 bottles","The sterility of the recalled products cannot be assured.",1/7/2013,"01/07/2013",5/29/2013,"05/29/2013"
"Veterinary",64903,"Ongoing","Bimeda MTC Animal Health Inc.","Cambridge",,"CA","Voluntary: Firm Initiated","Letter","Nationwide (KS and WI)","V-194-2013","Class II","50% Dextrose Injection, USP; Sterile Preservative Free; For Animal Use Only; Packaged in HDPE 500 mL bottle with a grey 30mm chlorobutyl rubber (siliconized) stopper and capped with a silver tear off aluminum seal.","Lot Number: 2J028; Item Number: 1DEX012; Expiry: 15 SEP",".","6,702 bottles","The sterility of the recalled products cannot be assured.",1/7/2013,"01/07/2013",5/29/2013,"05/29/2013"
"Veterinary",64903,"Ongoing","Bimeda MTC Animal Health Inc.","Cambridge",,"CA","Voluntary: Firm Initiated","Letter","Nationwide (KS and WI)","V-192-2013","Class II","Hypertonic Saline Solution 7.2%; Sterile - Preservative Free; For Animal Use Only; Packaged in HDPE 1000 mL bottle with a grey 30mm chlorobutyl rubber (silicone) stopper and capped with a silver tear off aluminum seal.","Lot Number: 2J041; Item Number: 1HYP009 - VETONE; Expiry: 14 SEP",".","8,447 bottles","The sterility of the recalled products cannot be assured.",1/7/2013,"01/07/2013",5/29/2013,"05/29/2013"
"Biologics",64905,"Terminated","American National Red Cross","Columbus","OH","US","Voluntary: Firm Initiated","FAX","OH","B-1634-13","Class III","Red Blood Cells Leukocytes Reduced","16KC44866",".","1 unit","Blood product, manufactured without additive solution, was distributed.",2/22/2013,"02/22/2013",7/10/2013,"07/10/2013"
"Biologics",64906,"Terminated","South Bend Medical Foundation, Inc.","South Bend","IN","US","Voluntary: Firm Initiated","Letter","IN","B-1633-13","Class II","Red Blood Cells Leukocytes Reduced","W045212002293",".","1 unit","Blood product, collected from a donor who traveled to a malarial endemic area, was distributed.",3/26/2013,"03/26/2013",7/10/2013,"07/10/2013"
"Food",64907,"Ongoing","Nexgen Pharma, Inc.","Colorado Springs","CO","US","Voluntary: Firm Initiated","Letter","Distributed to large and small retailers located nationwide as well as two foreign locations (Canada and Netherlands).","F-1338-2013","Class III","Free Form Amino Acids L-Arginine 7 L-Ornithine Complex With Alpha-Lipoic Acid, Promotes Circulation and Muscle Development, Dietary Supplement, 50 Vegetarian Capsules, Gluten Free, Serving Size 2 Capsules. Each product is produced for a specific customer with their distribution information on the label. A general label template was provided with attachment B information. Product is sold in 50 and 100 ct bottles.","Lot number 412567.",".","4571 bottles.","Nexgen Pharma is recalling a certain lot of dietary supplement L-Arginine L-Ornithine Alpha Lipoic Acid Capsules due to subpotency of the Alpha Lipoic Acid ingredient.",4/15/2013,"04/15/2013",5/1/2013,"05/01/2013"
"Devices",64908,"Ongoing","Covidien LLC","Mansfield","MA","US","Voluntary: Firm Initiated","Letter","Worldwide distribution: USA (nationwide) and in the country of: Panama.","Z-1304-2013","Class III","Curity Staple Remover Kit; Product Code: 66701. Staple Remover Kit.","103387264, 117881264, 110983964, 214981164, 117488864",,"52363 distributed","On March 26, 2013 Covidien received a recall notice from one of their suppliers CareFusion. CareFusion is recalling a variety of OTC drug products including the 10% Povidone Iodine SEPP Applicator which is utilized in specific convenience kits. ",4/12/2013,"04/12/2013",5/22/2013,"05/22/2013"
"Devices",64908,"Ongoing","Covidien LLC","Mansfield","MA","US","Voluntary: Firm Initiated","Letter","Worldwide distribution: USA (nationwide) and in the country of: Panama.","Z-1303-2013","Class III","Curity I.V. Start Kit, Product ID: 80530 and Curity I.V. Start Kit Product ID: 8508. IV Start Kit.","Product 80530: 032887164, 203184264,110983764, 208286764, 116480564, 221590564, 120987864, 236385564,127085464; Product 8508: 207383964, 23489464",,"17740 kits","On March 26, 2013 Covidien received a recall notice from one of their suppliers CareFusion. CareFusion is recalling a variety of OTC drug products including the 10% Povidone Iodine SEPP Applicator which is utilized in specific convenience kits. ",4/12/2013,"04/12/2013",5/22/2013,"05/22/2013"
"Food",64909,"Ongoing","Nuts Are Good! Inc.","Warren","MI","US","Voluntary: Firm Initiated","E-Mail","Domestic: OH, MI Kroger Retail Stores","F-1404-2013","Class II","Island Mix, 12 oz. with best by date of 02/17/2014","Best by Date of 02/17/2014",,"40 bags mislabeled ( a total of 6,240 were distributed)","Incorrect labeling and undeclared allergens , including Peanuts, Cashews, Almonds, Consumers who have an allergy or sensitivity to peanuts, Cashews, Almonds run the risk of serious or life-threatening allergic reactions. The product Island Mix packaged in a clear bag (dried fruit mixture) contained Peanuts, Cashews, Almonds.",3/22/2013,"03/22/2013",5/22/2013,"05/22/2013"
"Devices",64910,"Ongoing","Iris Diagnostics","Chatsworth","CA","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution - USA Nationwide and the countries of: Canada, Malaysia, Spain, Switzerland, Taiwan, Peru, France, Russia, Japan, United Kingdom, Germany, and Paraguay.","Z-1328-2013","Class II","Iris Diagnostics Division iQ Control/Focus Set, Part Number 800-3104, Lot Number 153-12. Product Usage: For in vitro diagnostic use with the iQ200 series.","Part Number 800-3104. Lot Number 153-12. Expiration date: Jan 2013",,"942 boxes","The firm initiated this recall because complaints from customers reported that the recovery compared to assigned assay values is significantly below specification. This results in the instrument not passing controls and the customer not being able to run patient samples.",9/18/2012,"09/18/2012",5/22/2013,"05/22/2013"
"Food",64911,"Ongoing","Fresh And Easy","El Segundo","CA","US","Voluntary: Firm Initiated","E-Mail","CA, AZ, NV","F-1328-2013","Class II","Fresh & Easy Organic 100% Apple Juice from concentrate, 64 oz, 8 units/case. UPC/Barcode: 50513790021007 ORIN: 100012615 SPORIN: 100012623 ","Lot Code: 3690430491, expiration 2/18/2014. Lot Code: 3690430701, expiration 3/11/2014. ",".","173 cases","Fresh and Easy is recalling Fresh & Easy Organic Apple Juice because it may be contaminated with patulin.",4/11/2013,"04/11/2013",4/24/2013,"04/24/2013"
"Food",64912,"Ongoing","S & M International Inc","Bayonne","NJ","US","Voluntary: Firm Initiated","Letter","New York","F-1395-2013","Class II","Tasty Snacks Sour Plum, (6 oz.), S&M(HK) Enterprise LTD, RM3 8/F Yuexiu BLDG., 160-174, Lockhart Road, Wan Chai, HK. Distributed By: S&M Int'l Inc. 100 Pulaski Street, Bayonne, NJ 07002. Product of China. Item No. 802578.","All lots ",,"Unknown","The recall was initiated after it was discovered through NYDAM Sampling which revealed the product Tasty Snacks Sour Plum contains undeclared sulfites/preservatives, contains unallowed dye:16185-Amaranth (E123)-Acid Red 27 and contains undeclared FD & C Yellow #6 ",3/15/2013,"03/15/2013",5/22/2013,"05/22/2013"
"Food",64912,"Ongoing","S & M International Inc","Bayonne","NJ","US","Voluntary: Firm Initiated","Letter","New York","F-1397-2013","Class III","Lam Sheng Kee Chinese Red Dates, (Net Weight 400 Grams), Lam Sheng Kee (HK) International Limited, RM3 8/F Yuexiu BLDG., 160-174, Lockhart Road, Wan Chai, HK. Distributed By: S&M Int'l Inc. 100 Pulaski Street, Bayonne, NJ 07002. Item #803810; Product of China.","All lots ",,"Unknown","The recall was initiated after it was discovered through NYDAM Sampling which revealed the product Lam Sheng Kee Red Dates contain unallowed dye basic violet 3. ",3/15/2013,"03/15/2013",5/22/2013,"05/22/2013"
"Food",64912,"Ongoing","S & M International Inc","Bayonne","NJ","US","Voluntary: Firm Initiated","Letter","New York","F-1394-2013","Class II","Grove Grow Notes Hawthorne , 400 Gram (14 oz.), S&M(HK) Enterprise LTD, RM3 8/F Yuexiu BLDG., 160-174, Lockhart Road, Wan Chai, HK. Deputy: S&M (USA) Enterprise 4703 2nd Avenue, Brooklyn, NY 11232. Product of China.","All lots ",,"Unknown","The recall was initiated after it was discovered through NYDAM Sampling which revealed the product Grove Grow Notes Hawthorne contains unallowed dye 16255,Ponceau 4R (E124)- Acid Red 18 and FD& C Yellow #5",3/15/2013,"03/15/2013",5/22/2013,"05/22/2013"
"Food",64912,"Ongoing","S & M International Inc","Bayonne","NJ","US","Voluntary: Firm Initiated","Letter","New York","F1396-2013","Class III","Lam Sheng Kee Mini Sausage Hong Kong Style, Net Weight 6.3 oz.), Lam Sheng Kee (HK) International Limited, RM3 8/F Yuexiu BLDG., 160-174, Lockhart Road, Wan Chai, HK. Distributed By: S&M Int'l Inc. 100 Pulaski Street, Bayonne, NJ 07002. ","All lots ",,"Unknown","The recall was initiated after it was discovered through NYDAM Sampling which revealed the product Lam Sheng Kee Mini Sausage contains undeclared FD&C Red #40 and undeclared minced fish (unknown fish species) ",3/15/2013,"03/15/2013",5/22/2013,"05/22/2013"
"Food",64912,"Ongoing","S & M International Inc","Bayonne","NJ","US","Voluntary: Firm Initiated","Letter","New York","F-1393-2013","Class II","Dried Mango (3.5oz.), S&M(HK) Enterprise LTD, RM3 8/F Yuexiu BLDG., 160-174, Lockhart Road, Wan Chai, HK. Distributed By: S&M Int'l Inc. 100 Pulaski Street, Bayonne, NJ 07002. Product of China. Item No. 802578.","All lots ",,"Unknown","The recall was initiated after it was discovered through NYDAM Sampling which revealed the product Dried Mango contains undeclared sulfites/preservatives. ",3/15/2013,"03/15/2013",5/22/2013,"05/22/2013"
"Devices",64913,"Ongoing","DePuy Mitek, Inc., a Johnson & Johnson Co.","Raynham","MA","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution - USA including KY, NJ and Internationally to Argnetina, Australia, Belgium,Columbia, India, France, Japan, Jordan, Latvija, Israel, Korea, and Great Britain. For questions regarding this recall call 508-977-3813.","Z-1278-2013","Class II","DePuy Mitek Tissue Liberator -Blade Up Catalog Number: 214623 The Reusable Arthroscopy Instruments are reusable, non-powered surgical instruments used during arthroscopic surgery of any joint except the spine. ","Lot number:13A01 ",".","27 units","Labeled incorrectly as a Blade Up configuration instead of a Blade Down configuration. ",4/15/2013,"04/15/2013",5/15/2013,"05/15/2013"
"Food",64914,"Ongoing","Clement Pappas & Co., Inc.","Carneys Point","NJ","US","Voluntary: Firm Initiated","E-Mail","Nationwide","F-1416-2013","Class II","Greenway Organic Apple Juice From Concentrate 64 FL Oz (2 QTS) 1.89L UPC 70625348405 Distributed by OnPoint Inc. 2 Paragon Drive Montvale, NJ 07645 ","Lot Number Exp Date 3690230351 2/4/2014 3690230421 2/11/2014 3690230491 2/18/2014 3690230561 2/25/2014 3690230701 3/11/2014",".",,"One of this products ingredients, Organic Apple Juice Concentrate, was found to contain patulin levels between 57.4-100 ppb.",4/11/2013,"04/11/2013",5/29/2013,"05/29/2013"
"Food",64914,"Ongoing","Clement Pappas & Co., Inc.","Carneys Point","NJ","US","Voluntary: Firm Initiated","E-Mail","Nationwide","F-1417-2013","Class II","Harris Teeter Organics Apple Juice 64 FL OZ (2 QT) 1.89 L UPC 072036764324 Proudly distributed by Harris Teeters Mathews, NC 28105 ","Lot Number Exp Date 3690230152 1/15/2014 3690230292 1/29/2014 3690230432 2/12/2014 3690230582 2/27/2014 3690230842 3/25/2014",".",,"One of this products ingredients, Organic Apple Juice Concentrate, was found to contain patulin levels between 57.4-100 ppb.",4/11/2013,"04/11/2013",5/29/2013,"05/29/2013"
"Food",64914,"Ongoing","Clement Pappas & Co., Inc.","Carneys Point","NJ","US","Voluntary: Firm Initiated","E-Mail","Nationwide","F-1418-2013","Class II","simple truth organic Apple Juice 100% 64 FL OZ (2 QT) 1.89 L UPC 011110834805 Distributed by The Kroger Co. Cincinnati OH 45202 ","Lot Number Exp Date 3690230152 1/15/2014 3690230292 1/29/2014 3690230432 2/12/2014 3690230582 2/27/2014 3690230351 2/4/2014 3690230621 3/3/2014",".",,"One of this products ingredients, Organic Apple Juice Concentrate, was found to contain patulin levels between 57.4-100 ppb.",4/11/2013,"04/11/2013",5/29/2013,"05/29/2013"
"Food",64914,"Ongoing","Clement Pappas & Co., Inc.","Carneys Point","NJ","US","Voluntary: Firm Initiated","E-Mail","Nationwide","F-1413-2013","Class II","Publix Market Greenwise Organic Cranberry Flavored Juice Blend 64 FL OZ (2 QTS) 1.89 L UPC 041415049208 Distributed by Publix Supermarkets Inc. Lakeland, FL 33802 publix.com","Lot Number Exp Date 1430230152 10/13/2013 1430230292 10/30/2013",".",,"One of this products ingredients, Organic Apple Juice Concentrate, was found to contain patulin levels between 57.4-100 ppb.",4/11/2013,"04/11/2013",5/29/2013,"05/29/2013"
"Food",64914,"Ongoing","Clement Pappas & Co., Inc.","Carneys Point","NJ","US","Voluntary: Firm Initiated","E-Mail","Nationwide","F-1427-2013","Class II","Trader Joe's Apple Juice 64 FL OZ (2 QT) 1.89 L UPC 00746854 Dist. & Sold Exclusively By: Trader Joe's Monrovia, CA 91016","Lot number Exp Date 3690230281 5/25/2014 3690230351 6/5/2014 3690230421 6/13/2014 3690230491 6/20/2014 3690230561 6/27/2014 3690230631 7/3/2014 3690230701 7/11/2014",".",,"One of this products ingredients, Organic Apple Juice Concentrate, was found to contain patulin levels between 57.4-100 ppb.",4/11/2013,"04/11/2013",5/29/2013,"05/29/2013"
"Food",64914,"Ongoing","Clement Pappas & Co., Inc.","Carneys Point","NJ","US","Voluntary: Firm Initiated","E-Mail","Nationwide","F-1414-2013","Class II","wild harvest organic apple juice 64 FL OZ (2 QTS) 1.89L UPC 011535025567 Distributed by Supervalu Inc. Eden Prairie, MN 55344 USA ","Lot Number Exp. Date 3690230281 1/28/2014 3690230351 2/4/2014 3690230491 2/18/2014 3690230561 2/25/2014 3690230771 3/18/2014",".",,"One of this products ingredients, Organic Apple Juice Concentrate, was found to contain patulin levels between 57.4-100 ppb.",4/11/2013,"04/11/2013",5/29/2013,"05/29/2013"
"Food",64914,"Ongoing","Clement Pappas & Co., Inc.","Carneys Point","NJ","US","Voluntary: Firm Initiated","E-Mail","Nationwide","F-1424-2013","Class II","Heinen's organic 100% Apple Juice 64 FL. OZ. (2QT) 1.89L UPC 020601403031 Distributed by: Heinen's, Inc, Warrensville Heights, OH 44128 ","Lot number Exp Date 3690230432 2/12/2014",".","187 units","One of this products ingredients, Organic Apple Juice Concentrate, was found to contain patulin levels between 57.4-100 ppb.",4/11/2013,"04/11/2013",5/29/2013,"05/29/2013"
"Food",64914,"Ongoing","Clement Pappas & Co., Inc.","Carneys Point","NJ","US","Voluntary: Firm Initiated","E-Mail","Nationwide","F-1420-2013","Class II","Full Circle Organic 100% Apple Juice 64 FL OZ (2 QT) 1.89 L UPC 36800043114 Distributed by Topco Associates LLC 7711 Gross Point Road, Skokie, Illinois 60077 www.fullcirclefoods.com","Lot Number Exp Date 3690230281 1/28/2014 3690230351 2/4/2014 3690230551 2/25/2014 3690230631 3/4/2014 3690230491 2/18/2014",".",,"One of this products ingredients, Organic Apple Juice Concentrate, was found to contain patulin levels between 57.4-100 ppb.",4/11/2013,"04/11/2013",5/29/2013,"05/29/2013"
"Food",64914,"Ongoing","Clement Pappas & Co., Inc.","Carneys Point","NJ","US","Voluntary: Firm Initiated","E-Mail","Nationwide","F-1412-2013","Class II","Organics Nature's Promise Organic Cranberry Juice Blend UPC 688267036163 - 64 FL OZ (2 QT) 1.89L Distributed by Foodhold USA LLC Landover, MD 20785 1-877-846-9949 ","Lot number Exp. Date 1430230351 11/15/2013 1430230561 11/26/2013 1430230701 12/10/2013 ",".",,"One of this products ingredients, Organic Apple Juice Concentrate, was found to contain patulin levels between 57.4-100 ppb.",4/11/2013,"04/11/2013",5/29/2013,"05/29/2013"
"Food",64914,"Ongoing","Clement Pappas & Co., Inc.","Carneys Point","NJ","US","Voluntary: Firm Initiated","E-Mail","Nationwide","F-1428-2013","Class II","1) Organics Nature's Promise Organic Apple Juice 64 FL OZ (2 QT) 1.89L UPC 688267036156 Distributed by Foodhold USA LLC Landover, MD 20785 1-877-846-9949 2) Organics Nature's Promise Organic Apple Juice 6.75 FL OZ (200 mL) UPC 688267063107 Distributed by Foodhold USA LLC Landover, MD 20785 1-877-846-9949 ","64 fl oz. Lot number Exp. Date 3690630281 1/28/2014 3690630351 2/4/2014 3690630421 2/11/2014 3690630561 2/25/2014 3690630631 3/4/2014 3690630701 3/11/2014 3690630841 3/25/2014 6.75 fl oz. Lot number Exp. Date 8240030101 1/10/2014 82400.0111 1/11/2014 8240030451 2/14/2014 ",".",,"One of this products ingredients, Organic Apple Juice Concentrate, was found to contain patulin levels between 57.4-100 ppb.",4/11/2013,"04/11/2013",5/29/2013,"05/29/2013"
"Food",64914,"Ongoing","Clement Pappas & Co., Inc.","Carneys Point","NJ","US","Voluntary: Firm Initiated","E-Mail","Nationwide","F-1422-2013","Class II","Wegmans Organic Apple Juice 64 FL OZ (2 QT) 1.89 L UPC 077890206058 Distributed by: Wegmans Food Markets, Inc. Rochester, NY 14603","Lot Number Exp Date 3690230281 1/28/2014 3690230351 2/4/2014 3690230421 2/11/2014 3690230491 2/18/2014 3690230561 2/25/2014 3690230631 3/4/2014 3690230701 3/11/2014 3690230771 3/18/2014 3690230781 3/19/2014",".",,"One of this products ingredients, Organic Apple Juice Concentrate, was found to contain patulin levels between 57.4-100 ppb.",4/11/2013,"04/11/2013",5/29/2013,"05/29/2013"
"Food",64914,"Ongoing","Clement Pappas & Co., Inc.","Carneys Point","NJ","US","Voluntary: Firm Initiated","E-Mail","Nationwide","F-1426-2013","Class II","Best Choice Clearly Organic Organic Apple Juice Net Wt 64 FL OZ (2 QT) 1.89 L UPC 070038614395 Proudly Distributed By : Associated Wholesale Grocers Inc., Kansas City, Kansas 66106 ","Lot number Exp Date 3690230152 1/15/2014 3690230292 1/29/2014",".",,"One of this products ingredients, Organic Apple Juice Concentrate, was found to contain patulin levels between 57.4-100 ppb.",4/11/2013,"04/11/2013",5/29/2013,"05/29/2013"
"Food",64914,"Ongoing","Clement Pappas & Co., Inc.","Carneys Point","NJ","US","Voluntary: Firm Initiated","E-Mail","Nationwide","F-1419-2013","Class II","meijier Organics Cranberry Juice Net 64 FL OZ(2 QT) 1.89 L UPC 719283661562 Dist By Meijier Distribution Inc. Grand Rapids, MI 49544 ","Lot Number Exp Date 1430230701 12/10/2013",".",,"One of this products ingredients, Organic Apple Juice Concentrate, was found to contain patulin levels between 57.4-100 ppb.",4/11/2013,"04/11/2013",5/29/2013,"05/29/2013"
"Food",64914,"Ongoing","Clement Pappas & Co., Inc.","Carneys Point","NJ","US","Voluntary: Firm Initiated","E-Mail","Nationwide","F-1415-2013","Class II","wild harvest organic cranberry 64 FL OZ (2 QTS) 1.89L UPC 011535500408 Distributed by Supervalu Inc. Eden Prairie, MN 55344 USA ","Lot Number Exp Date 1430230351 11/5/2013 1430230561 11/26/2013 ",".",,"One of this products ingredients, Organic Apple Juice Concentrate, was found to contain patulin levels between 57.4-100 ppb.",4/11/2013,"04/11/2013",5/29/2013,"05/29/2013"
"Food",64914,"Ongoing","Clement Pappas & Co., Inc.","Carneys Point","NJ","US","Voluntary: Firm Initiated","E-Mail","Nationwide","F-1425-2013","Class II","Full Circle Organic 100 % Cranberry Juice Blend 64 FL OZ (2 QT) 1.89 L UPC 03600079045 Distributed by Topco Associates LLC 7711 Gross Point Road, Skokie, Illinois 60077 www.fullcirclefoods.com","Lot number Exp Date 1430230491 11/18/2013 ",".",,"One of this products ingredients, Organic Apple Juice Concentrate, was found to contain patulin levels between 57.4-100 ppb.",4/11/2013,"04/11/2013",5/29/2013,"05/29/2013"
"Food",64914,"Ongoing","Clement Pappas & Co., Inc.","Carneys Point","NJ","US","Voluntary: Firm Initiated","E-Mail","Nationwide","F-1423-2013","Class II","Wegmans Organic Cranberry Juice Blend 64 FL OZ (2 QT) 1.89 L UPC 077890266892 Distributed by: Wegmans Food Markets, Inc. Rochester, NY 14603","Lot number Exp Date 1430230351 11/15/2013 ",".",,"One of this products ingredients, Organic Apple Juice Concentrate, was found to contain patulin levels between 57.4-100 ppb.",4/11/2013,"04/11/2013",5/29/2013,"05/29/2013"
"Food",64914,"Ongoing","Clement Pappas & Co., Inc.","Carneys Point","NJ","US","Voluntary: Firm Initiated","E-Mail","Nationwide","F-1421-2013","Class II","Giant Eagle Nature's Basket Organic Apple Juice Net 64 FL OZ (2 QT) 1.89 L UPC 030034056063 Distributed by Giant Eagle Inc. Pittsburgh, PA 15238-2809","Lot Number Exp Date 3690230281 1/28/2014 3690230491 2/18/2014 3690230351 2/4/2014 3690230701 3/11/2014",".",,"One of this products ingredients, Organic Apple Juice Concentrate, was found to contain patulin levels between 57.4-100 ppb.",4/11/2013,"04/11/2013",5/29/2013,"05/29/2013"
"Food",64914,"Ongoing","Clement Pappas & Co., Inc.","Carneys Point","NJ","US","Voluntary: Firm Initiated","E-Mail","Nationwide","F-1429-2013","Class II","Giant Eagle Nature's Basket Organic Cranberry Net 64 FL OZ (2 QT) 1.89 L UPC 030034056070 Distributed by Giant Eagle Inc. Pittsburgh, PA 15238-2809 ","Lot number Exp. Date 1430230351 11/5/2013 1430230701 12/10/2013 ",".",,"One of this products ingredients, Organic Apple Juice Concentrate, was found to contain patulin levels between 57.4-100 ppb.",4/11/2013,"04/11/2013",5/29/2013,"05/29/2013"
"Biologics",64915,"Terminated","OneBlood, Inc.","Lakeland","FL","US","Voluntary: Firm Initiated","FAX","Florida","B-1779-13","Class II","Red Blood Cells Leukocytes Reduced","W03551095306800; ",,"1","Blood products, collected from a donor who was not deferred after testing reactive for HTLV-I/II, were distributed.",12/26/2012,"12/26/2012",8/7/2013,"08/07/2013"
"Food",64916,"Ongoing","Win Luck Trading Inc","Bayonne","NJ","US","Voluntary: Firm Initiated","Letter","New York","F-1437-2013","Class I","Lam Sheng Kee, Frozen White Fish Ball - Shrimp Ball Net Weight 7 oz (200 G) - Sheng Lin Mark Trade Co. LTD 4 F. No 89, Ln. 528 Heping Road, Bade City, Taoyuan County 334, Taiwan (ROC). Distributed by: Win Luck Trading Inc. 100 Pulaski Street, Bayonne, NJ 07002.","All lots",".","Unknown","The recall was initiated after it was discovered the label failed to list the common name Albumin as egg; also the species of fish was not declared in the ingredient statement. ",3/25/2013,"03/25/2013",5/29/2013,"05/29/2013"
"Food",64916,"Ongoing","Win Luck Trading Inc","Bayonne","NJ","US","Voluntary: Firm Initiated","Letter","New York","F-1439-2013","Class I","Lam Sheng Kee, Frozen White Fish Ball - Fish Package Egg, Net Weight 7 oz (200 G) - Sheng Lin Mark Trade Co. LTD 4 F. No 89, Ln. 528 Heping Road, Bade City, Taoyuan County 334, Taiwan (ROC). Distributed by: Win Luck Trading Inc. 100 Pulaski Street, Bayonne, NJ 07002.","All lots",".","Unknown","The recall was initiated after it was discovered the label failed to list the common name Albumin as egg; also the species of fish was not declared in the ingredient statement. ",3/25/2013,"03/25/2013",5/29/2013,"05/29/2013"
"Food",64916,"Ongoing","Win Luck Trading Inc","Bayonne","NJ","US","Voluntary: Firm Initiated","Letter","New York","F-1438-2013","Class I","Lam Sheng Kee, Frozen White Fish Ball - Lobster Ball Net Weight 7 oz (200 G) - Sheng Lin Mark Trade Co. LTD 4 F. No 89, Ln. 528 Heping Road, Bade City, Taoyuan County 334, Taiwan (ROC). Distributed by: Win Luck Trading Inc. 100 Pulaski Street, Bayonne, NJ 07002.","All lots",".","Unknown","The recall was initiated after it was discovered the label failed to list the common name Albumin as egg; also the species of fish was not declared in the ingredient statement. ",3/25/2013,"03/25/2013",5/29/2013,"05/29/2013"
"Food",64916,"Ongoing","Win Luck Trading Inc","Bayonne","NJ","US","Voluntary: Firm Initiated","Letter","New York","F-1440-2013","Class I","Lam Sheng Kee, Frozen White Fish Ball - Fresh Fish Cake, Net Weight 7 oz (200 G) - Sheng Lin Mark Trade Co. LTD 4 F. No 89, Ln. 528 Heping Road, Bade City, Taoyuan County 334, Taiwan (ROC). Distributed by: Win Luck Trading Inc. 100 Pulaski Street, Bayonne, NJ 07002.","All lots",".","Unknown","The recall was initiated after it was discovered the label failed to list the common name Albumin as egg; also the species of fish was not declared in the ingredient statement. ",3/25/2013,"03/25/2013",5/29/2013,"05/29/2013"
"Food",64917,"Ongoing","Cedarlane Natural Foods Inc/Frankly Fresh Foods Inc.","Carson","CA","US","Voluntary: Firm Initiated","Press Release","CA","F-1349-2013","Class I","O Organics Black Bean Enchiladas 9 oz. ","Best Before date of Oct 26 2013 Lot Code: S1596OCT2613A",".","178 cases","Cedarlane Natural Foods is recalling one specific lot of O Organics Black Bean Enchiladas because it contains undeclared milk.",4/15/2013,"04/15/2013",5/1/2013,"05/01/2013"
"Devices",64918,"Ongoing","GE Healthcare, LLC","Waukesha","WI","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution-USA (nationwide) including DC and Puerto Rico, excluding the state of RI and the countries of Yugoslavia YEMEN Viet Nam Venezuela Uzbekistan Uruguay United Arab Emirates Tunisia Thailand Tanzania Taiwan Turkey Syria Switzerland Sweden Spain South Korea South Africa Slovenia Slovakia Singapore Saudi Arabia Russia Romania Reunion Qatar Portugal Poland Philippines Peru Pakistan Paraguay Philippines Oman Norway Nigeria New Zealand Netherlands Morocco Mexico Martinique Malaysia Macedonia Mauritania Luxembourg Lithuania Libya Lebanon Latvia Kuwait Kenya Korea Korea (Republic Of [South] Korea) KUWAIT Kazakhstan Jordan Japan Jamaica Italy Israel Ireland Iran Iraq Indonesia India Hungary Hong Kong Honduras Guadeloupe Greece Germany Georgia, Republic of French Polynesia France Finland Estonia Ecuador Egypt Denmark Dominican Republic Czech Republic Croatia Colombia China Chile Canada Bulgaria Brazil Bosnia And Herzegovina Belgium Belarus Barbados Bahrain Austria Australia Argentina Arab Emirates Algeria and United Kingdom.","Z-1208-2013","Class II","GE Healthcare, GE 1.5T SIGNA HDe MR SYSTEM. Indicated for use as a diagnostic imaging device.","Mfg Lot or Serial # 00000004984YR1 00000005068YR2 00000005079YR9 00000005080YR7 00000005081YR5 00000005648YR1 00000005656YR4 00000005659YR8 00000005664YR8 00000006155YR6 00000006157YR2 00000006172YR1 00000006176YR2 00000006177YR0 00000006188YR7 00000006194YR5 00000006198YR6 00000006200YR0 00000006204YR2 00000006514YR4 00000006515YR1 00000006516YR9 00000006519YR3 00000006522YR7 00000006525YR0 00000006528YR4 00000006532YR6 00000006535YR9 00000006538YR3 00000006544YR1 00000007947YR5 00000007954YR1 00000007969YR9 00000007970YR7 00000007971YR5 00000008692YR6 00000008698YR3 00000008699YR1 00000008701YR5 00000008703YR1 00000008709YR8 00000008715YR5 00000008716YR3 00000008720YR5 00000008726YR2 00000008727YR0 00000008728YR8 00000008729YR6 00000008732YR0 00000008734YR6 00000009833YR5 00000010024YR8 00000010025YR5 00000010114YR7 00000010578YR3 00000010580YR9 00000010583YR3 00000010686YR4 00000010794YR6 00000010795YR3 00000010830YR8 00000010831YR6 00000010834YR0 00000010856YR3 00000010863YR9 00000011210YR2 00000011428YR0 00000011429YR8 00000011495YR9 00000011499YR1 00000011637YR6 00000011648YR3 00000011650YR9 00000011669YR9 00000011686YR3 00000011826YR5 00000011829YR9 00000011830YR7 00000011842YR2 00000012085YR7 00000012098YR0 00000012099YR8 00000012100YR4 00000012102YR0 00000012142YR6 00000012172YR3 00000012206YR9 00000012207YR7 00000012221YR8 00000012227YR5 00000012286YR1 00000012287YR9 00000012289YR5 00000012330YR7 00000012393YR5 00000012434YR7 00000012435YR4 00000012503YR9 00000012507YR0 00000012576YR5 00000012651YR6 00000012652YR4 00000012727YR4 00000012728YR2 00000012755YR5 00000012756YR3 00000012818YR1 00000012820YR7 00000012940YR3 00000012943YR7 00000012988YR2 00000012992YR4 00000012994YR0 00000012995YR7 00000013056YR7 00000013061YR7 00000013177YR1 00000013180YR5 00000013185YR4 00000013239YR9 00000013241YR5 00000013246YR4 00000013301YR7 00000013306YR6 00000013310YR8 00000013375YR1 00000013379YR3 00000013384YR3 00000013385YR0 00000013399YR1 00000013453YR6 00000013799YR2 00000013800YR8 00000013802YR4 00000013804YR0 ",,"822 (154 US; 668 OUS)","GE Healthcare has recently become aware of a Reformat Image Flip Issue associated with GE MR Products. The axial and coronal reformatted images from a sagittal 3D series (such as with applications of FSPGR-3D T1, BRAVO T1, or CUBE T1) of over 126 slices may display a left-to-right image flip . In addition, the acquired sagittal images may be annotated with left-right location annotation reversed. This issue may lead to incorrect localization of findings, particularly where symmetric anatomy is present.",6/8/2012,"06/08/2012",5/8/2013,"05/08/2013"
"Devices",64918,"Ongoing","GE Healthcare, LLC","Waukesha","WI","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution-USA (nationwide) including DC and Puerto Rico, excluding the state of RI and the countries of Yugoslavia YEMEN Viet Nam Venezuela Uzbekistan Uruguay United Arab Emirates Tunisia Thailand Tanzania Taiwan Turkey Syria Switzerland Sweden Spain South Korea South Africa Slovenia Slovakia Singapore Saudi Arabia Russia Romania Reunion Qatar Portugal Poland Philippines Peru Pakistan Paraguay Philippines Oman Norway Nigeria New Zealand Netherlands Morocco Mexico Martinique Malaysia Macedonia Mauritania Luxembourg Lithuania Libya Lebanon Latvia Kuwait Kenya Korea Korea (Republic Of [South] Korea) KUWAIT Kazakhstan Jordan Japan Jamaica Italy Israel Ireland Iran Iraq Indonesia India Hungary Hong Kong Honduras Guadeloupe Greece Germany Georgia, Republic of French Polynesia France Finland Estonia Ecuador Egypt Denmark Dominican Republic Czech Republic Croatia Colombia China Chile Canada Bulgaria Brazil Bosnia And Herzegovina Belgium Belarus Barbados Bahrain Austria Australia Argentina Arab Emirates Algeria and United Kingdom.","Z-1209-2013","Class II","GE Healthcare, Optima MR360/Brivo MR355 (HDsv), GE 0.35T Signa Ovation HD MR System, GE 0.2T Signa Profile HD MR System. Indicated for use as a diagnostic imaging device.","Mfg Lot or Serial # 284481HM9 283390HM3 282416HM7 300218HM5 296431HM0 294361HM1 296436HM9 278690HM3 285914HM8 300212HM8 302728HM1 286892HM5 294373HM6 284475HM1 274212HM0 294150HM8 286871HM9 285458HM6 285464HM4 285905HM6 286889HM1 289113HM3 290003HM3 290018HM1 295187HM9 295708HM2 297795HM7 298512HM5 298518HM2 300206HM0 300209HM4 300905HM7 300911HM5 305123HM2 305132HM3 305141HM4 305300HM6 305303HM0 306320HM3 307364HM0 307373HM1 307376HM4 308186HM6 308923HM2 309476HM0 202350HM5 213385HM8 226223HM6 238928HM6 241057HM9 266117HM1 176965HM2 179337HM1 201787HM9 229961HM8 274239HM3 274891HM1 302722HM4 271715HM5 273786HM4 190565HM2 263639HM7 190926HM6 191138HM7 203039HM3 208218HM8 242119HM6 262861HM8 239003HM7 173924HM2 223179HM3 200595HM7 220569HM8 200583HM3 237533HM5 202684HM7 227617HM8 231629HM7 289983HM9 257774HM0 295726HM4 301810HM8 282422HM5 286886HM7 274218HM7 267655HM9 210567HM4 286868HM5 263617HM3 266951HM3 254615HM8 187938HM6 196629HM0 238231HM5 282404HM3 167486HM0 199901HM0 193891HM9 173912HM7 170636HM5 294147HM4 244336HM4 292524HM6 179350HM4 170947HM6 233942HM2 162548HM2 293800HM9 227765HM5 286874HM3 230345HM1 174556HM1 213014HM4 192701HM1 238597HM9 184917HM3 268113HM8 221655HM4 254616HM6 269129HM3 283384HM6 281434HM1 283387HM9 285455HM2 285449HM5 250051HM0 265004HM2 257789HM8 256150HM4 235822HM4 176555HM1 206273HM5 264194HM2 267204HM6 293080HM8 262350HM2 268124HM5 211504HM6 195579HM8 202478HM4 252485HM8 187478HM3 297798HM1 285461HM0 267698HM9 249448HM2 286027HM8 260953HM5 210554HM2 265012HM5 193026HM2 211535HM0 269423HM0 172347HM7 266962HM0 195447HM8 262850HM1 294144HM1 206272HM7 267685HM6 170573HM0 173420HM1 293095HM6 195469HM2 226804HM3 222527HM4 208276HM6 241705HM3 297318HM8 297813HM8 237249HM8 187075HM7 170080HM6 294141HM7 186769HM6 297816HM1 293809HM0 208920HM9 247326HM2 293803HM3 172348HM5 298503HM4 237600HM2 191146HM0 286030HM2 296445HM0 247348HM6 187173HM0 238213HM3 292530HM3 295717HM3 297303HM0 297789HM0 307336HM8 307351HM7 307354HM1 307367HM3 307379HM8 308180HM9 308907HM5 202345HM5 204158HM0 20590",,"864 (57 US; 802 OUS)","GE Healthcare has recently become aware of a Reformat Image Flip Issue associated with GE MR Products. The axial and coronal reformatted images from a sagittal 3D series (such as with applications of FSPGR-3D T1, BRAVO T1, or CUBE T1) of over 126 slices may display a left-to-right image flip . In addition, the acquired sagittal images may be annotated with left-right location annotation reversed. This issue may lead to incorrect localization of findings, particularly where symmetric anatomy is present.",6/8/2012,"06/08/2012",5/8/2013,"05/08/2013"
"Devices",64918,"Ongoing","GE Healthcare, LLC","Waukesha","WI","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution-USA (nationwide) including DC and Puerto Rico, excluding the state of RI and the countries of Yugoslavia YEMEN Viet Nam Venezuela Uzbekistan Uruguay United Arab Emirates Tunisia Thailand Tanzania Taiwan Turkey Syria Switzerland Sweden Spain South Korea South Africa Slovenia Slovakia Singapore Saudi Arabia Russia Romania Reunion Qatar Portugal Poland Philippines Peru Pakistan Paraguay Philippines Oman Norway Nigeria New Zealand Netherlands Morocco Mexico Martinique Malaysia Macedonia Mauritania Luxembourg Lithuania Libya Lebanon Latvia Kuwait Kenya Korea Korea (Republic Of [South] Korea) KUWAIT Kazakhstan Jordan Japan Jamaica Italy Israel Ireland Iran Iraq Indonesia India Hungary Hong Kong Honduras Guadeloupe Greece Germany Georgia, Republic of French Polynesia France Finland Estonia Ecuador Egypt Denmark Dominican Republic Czech Republic Croatia Colombia China Chile Canada Bulgaria Brazil Bosnia And Herzegovina Belgium Belarus Barbados Bahrain Austria Australia Argentina Arab Emirates Algeria and United Kingdom.","Z-1207-2013","Class II","GE Healthcare, Discovery MR750, Discovery 450, Optima 450W (with and without GEM), Signa HDx, Signa HDxt, Signa HDi, Signa Vibrant. Indicated for use as a diagnostic imaging device.","Mfg Lot or Serial # 00000029854MR5 00000030086MR1 00000030154MR0 00000235678MR0 00000235678MR0 00000288408MR8 00000289961MR5 00000290137MR9 00000292634MR3 00000292964MR4 00000292964MR4 00000293015MR4 00000293338MR0 00000293646MR6 00000293874MR4 00000293918MR9 00000294018MR7 00000294057MR5 00000294098MR9 00000294280MR3 00000294472MR6 00000294494MR0 00000294556MR6 00000294576MR4 00000294643MR2 00000294665MR5 00000294718MR2 00000294913MR9 00000294953MR5 00000295024MR4 00000295092MR1 00000295112MR7 00000295134MR1 00000295215MR8 00000295228MR1 00000295241MR4 00000295506MR0 00000295904MR7 00000296014MR4 00000296046MR6 00000296070MR6 00000296096MR1 00000296097MR9 00000296171MR2 00000296226MR0 00000296228MR0 00000296307MR2 00000296369MR2 00000296418MR7 00000296429MR4 00000296461MR7 00000296462MR5 00000296469MR0 00000296512MR7 00000296517MR6 00000296573MR9 00000296595MR2 00000296602MR6 00000296626MR5 00000296640MR6 00000296821MR2 00000296829MR5 00000296840MR2 00000296860MR0 00000296888MR1 00000296894MR9 00000296908MR7 00000297006MR9 00000297134MR9 00000297147MR1 00000297355MR0 00000297374MR1 00000297387MR3 00000297469MR9 00000297493MR9 00000297624MR9 00000297649MR6 00000297833MR6 00000297880MR7 00000297891MR4 00000298050MR6 00000298083MR7 00000298181MR9 00000298247MR8 00000298248MR6 00000298249MR4 00000298283MR3 00000298310MR4 00000298334MR4 00000298386MR4 00000298387MR2 00000298399MR7 00000298474MR8 00000298494MR6 00000298512MR5 00000298535MR6 00000298537MR2 00000298552MR1 00000298573MR7 00000298574MR5 00000298580MR2 00000298591MR9 00000298655MR2 00000298656MR0 00000298675MR0 00000298677MR6 00000298722MR0 00000298727MR9 00000298738MR6 00000298834MR3 00000298861MR6 00000298869MR9 00000298870MR7 00000298889MR7 00000298901MR0 00000298907MR7 00000298908MR5 00000298932MR5 00000298943MR2 00000298959MR8 00000298981MR2 00000299141MR2 00000299160MR2 00000299161MR0 00000299171MR9 00000299172MR7 00000299173MR5 00000299181MR8 00000299199MR0 00000299200MR6 00000299213MR9 00000299230MR3 00000299250MR1 00000299291MR5 00000299294MR9 "," 00000296863MR4 00000297381MR6 00001003BD642F 00000294308MR2 00000294986MR5 00000298063MR9 00000300501MR4 00000300849MR7 00000301739MR9 00000006723YR1 00000007114YR2 00000007847YR7 00000008325YR3 00000009054YR8 00000268685MR5 00000011097YR3 00000298557MR0 00000011189YR8 00000011199YR7 00000011326YR6 00000011561YR8 00000012059YR2 00000012121YR0 00000275533MR8 00000285677MR1 00000286649MR9 00000289162MR0 00000290054MR6 00000294344MR7 00000296238MR9 00000296865MR9 00000298215MR5 00000912BD59A1 00001012BD66A2 00000009574YR5 00000010254YR3 00000011553YR5 00001046XF502A 00001047XF5005 00001052XF509C 00001102XF502E 00001219FMM0FY 00000303326MR3 00001101XF5025 00000298265MR0 00000298790MR7 00000298804MR6 00000298806MR1 00000301038MR6 00001011BD667B 00000294516MR0 00000297422MR8 00000298944MR0 00000299292MR3 00000301293MR7 00000301963MR5 00000005567YR3 00000007520YR0 00000007539YR0 00000010425YR7 00000290007MR4 00000011734YR1 00000241874MR7 00000262064MR9 00000275175MR8 00000283302MR8 00000284233MR4 00001001BD631D UNK51078490008 00000006721YR5 00000009418YR5 00000009531YR5 00000297175MR2 00000297386MR5 00000293521MR1 00000293920MR5 00000295538MR3 00000295710MR8 00000298674MR3 00000300298MR7 00000006665YR4 00000008532YR4 00000009456YR5 00000012127YR7 00000012187YR1 00000027810MR1 000000HDMR5592 00000295902MR1 00000296047MR4 00000297404MR6 00000950BD628D 00000950BD62AA 00000009429YR2 00000291675MR7 00000293000MR6 00000296547MR3 00001106XF50B1 00001204FMM04T 00001140FMM0G1 00000297154MR7 00000299452MR3 00000300452MR0 00000301496MR6 00000302432MR0 00000008311YR3 00000010141YR0 00000010309YR3 000000105258M0 00000010618YR3 00000010972YR8 00000010991YR8 00000293935MR3 00000011206YR0 00000011221YR9 00000011232YR6 00000011264YR9 00000011324YR1 00000011332YR4 00000011788YR7 00000012011YR3 00000012046YR9 00000012134YR3 00000243187MR2 00000261729MR8 00000265005MR9 00000275466MR1 00000280781MR6 00000281056MR2 00000283516MR3 00000286157MR3 00000287425MR3 00000287847MR8 00000288193MR6 00000289319MR6 00000289339MR4 00000293672MR2 0000","4338","GE Healthcare has recently become aware of a Reformat Image Flip Issue associated with GE MR Products. The axial and coronal reformatted images from a sagittal 3D series (such as with applications of FSPGR-3D T1, BRAVO T1, or CUBE T1) of over 126 slices may display a left-to-right image flip . In addition, the acquired sagittal images may be annotated with left-right location annotation reversed. This issue may lead to incorrect localization of findings, particularly where symmetric anatomy is present.",6/8/2012,"06/08/2012",5/8/2013,"05/08/2013"
"Devices",64919,"Ongoing","Owens & Minor Distribution, Inc.","Mechanicsville","VA","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","US Nationwide Distribution.","Z-1192-2013","Class II","MediChoice Rayon Tipped OB/GYN Applicator, 8 inch, Plastic Shaft, Non-Sterile, Item Numbers WOD5001 and WOD5002. Product Usage: Usage: An absorbent tipped applicator is a device intended for medical purposes that consists of an absorbent swab on a wooden, paper, or plastic stick. The device is used to apply medications to, or to take specimens from, a patient. ","Item # Lot# WOD5001 1206DG13A WOD5001 1206DG13B WOD5001 1207DG13A WOD5001 1208DG13A WOD5001 1209DG13A WOD5001 1210DG13A/B WOD5001 1211DG13A WOD5001 1212DG13A WOD5001 1301DG13A WOD5001 1303DG13A WOD5002 1206DG14A WOD5002 1208DG14A WOD5002 1209DG14A WOD5002 1211DG14A Expiration Dates: 2017-05, 2017-06, 2017-06, 2017-07, 2017-08, 2017-09, 2017-10, 2017-11, 2018-02. ",,"4298.5 cases","Owens & Minor Distribution, Inc. is conducting a market withdrawal of MediChoice Applicator OB-GYN 8 inch product that does not meet our quality standards because the rayon may loosen or unravel from the applicator during use.",3/26/2013,"03/26/2013",5/8/2013,"05/08/2013"
"Veterinary",64920,"Ongoing","Lloyd Inc. of Iowa","Shenandoah","IA","US","Voluntary: Firm Initiated","Letter","Distribution was made nationwide, including Puerto Rico, Guatemala and Israel. Specific distribution will be reported.","V-149-2013","Class III","Lloyd Thyro-Tabs, levothyroxine sodium tablets, USP, 0.1mg, packaged in 120-ct bottles (NDC 11789-251-10), Lloyd, Shenandoah, IA. ","Lot: VKE29211, Exp date: Jul-13",".","14,439/120-ct bottles","The product Lot number and/or Expiration Date may be illegible or may be erased.",4/4/2013,"04/04/2013",5/15/2013,"05/15/2013"
"Veterinary",64920,"Ongoing","Lloyd Inc. of Iowa","Shenandoah","IA","US","Voluntary: Firm Initiated","Letter","Distribution was made nationwide, including Puerto Rico, Guatemala and Israel. Specific distribution will be reported.","V-153-2013","Class III","Lloyd Thyro-Tabs, levothyroxine sodium tablets, USP, 0.6 mg, packaged in 120-ct bottles (NDC 11789-256-10), Lloyd, Shenandoah, IA. ","Lot:: KA32511, Exp date: Aug-13",".","15,024/120-ct bottles","The product Lot number and/or Expiration Date may be illegible or may be erased.",4/4/2013,"04/04/2013",5/15/2013,"05/15/2013"
"Veterinary",64920,"Ongoing","Lloyd Inc. of Iowa","Shenandoah","IA","US","Voluntary: Firm Initiated","Letter","Distribution was made nationwide, including Puerto Rico, Guatemala and Israel. Specific distribution will be reported.","V-156-2013","Class III","Lloyd Thyro-Tabs, levothyroxine sodium tablets, USP, 0.8 mg, packaged in 120-ct bottles (NDC 11789-258-10), Lloyd, Shenandoah, IA. ","Lot:: VKB30711, Exp date: Aug-13 and Lot:: VKB02412, Exp date: Nov-13 ",".","23,717/120-ct bottles","The product Lot number and/or Expiration Date may be illegible or may be erased.",4/4/2013,"04/04/2013",5/15/2013,"05/15/2013"
"Veterinary",64920,"Ongoing","Lloyd Inc. of Iowa","Shenandoah","IA","US","Voluntary: Firm Initiated","Letter","Distribution was made nationwide, including Puerto Rico, Guatemala and Israel. Specific distribution will be reported.","V-154-2013","Class III","Lloyd Thyro-Tabs, levothyroxine sodium tablets, USP, 0.5 mg, packaged in 120-ct bottles (NDC 11789-255-10), Lloyd, Shenandoah, IA. ","Lot:: VKA31311, Exp date: Aug-13",".","14,669/120-ct bottles","The product Lot number and/or Expiration Date may be illegible or may be erased.",4/4/2013,"04/04/2013",5/15/2013,"05/15/2013"
"Veterinary",64920,"Ongoing","Lloyd Inc. of Iowa","Shenandoah","IA","US","Voluntary: Firm Initiated","Letter","Distribution was made nationwide, including Puerto Rico, Guatemala and Israel. Specific distribution will be reported.","V-151-2013","Class III","Lloyd Thyro-Tabs, levothyroxine sodium tablets, USP, 0.3 mg, packaged in 120-ct bottles (NDC 11789-253-10), Lloyd, Shenandoah, IA. ","Lot:: KA32111, Exp date: Aug-13; Lot: KA32111A, Exp date: Aug-13",".","12,387/120-ct bottles","The product Lot number and/or Expiration Date may be illegible or may be erased.",4/4/2013,"04/04/2013",5/15/2013,"05/15/2013"
"Veterinary",64920,"Ongoing","Lloyd Inc. of Iowa","Shenandoah","IA","US","Voluntary: Firm Initiated","Letter","Distribution was made nationwide, including Puerto Rico, Guatemala and Israel. Specific distribution will be reported.","V-150-2013","Class III","Lloyd Thyro-Tabs, levothyroxine sodium tablets, USP, 0.2 mg, packaged in 120-ct bottles (NDC 11789-252-10), Lloyd, Shenandoah, IA. ","Lot:: KB33411, Exp date: Sep-13; Lot: KB33411A, Exp date: Sep-13",".","12,387/120-ct bottles","The product Lot number and/or Expiration Date may be illegible or may be erased.",4/4/2013,"04/04/2013",5/15/2013,"05/15/2013"
"Veterinary",64920,"Ongoing","Lloyd Inc. of Iowa","Shenandoah","IA","US","Voluntary: Firm Initiated","Letter","Distribution was made nationwide, including Puerto Rico, Guatemala and Israel. Specific distribution will be reported.","V-157-2013","Class III","Lloyd Thyro-Tabs, levothyroxine sodium tablets, USP, 1.0 mg, packaged in 120-ct bottles (NDC 11789-268-10), Lloyd, Shenandoah, IA. ","Lot:: VKF33611, Exp date: Sep-13 and Lot:: VKF33611A, Exp date: Sep-13 ",".","11,122/120-ct bottles","The product Lot number and/or Expiration Date may be illegible or may be erased.",4/4/2013,"04/04/2013",5/15/2013,"05/15/2013"
"Veterinary",64920,"Ongoing","Lloyd Inc. of Iowa","Shenandoah","IA","US","Voluntary: Firm Initiated","Letter","Distribution was made nationwide, including Puerto Rico, Guatemala and Israel. Specific distribution will be reported.","V-155-2013","Class III","Lloyd Thyro-Tabs, levothyroxine sodium tablets, USP, 0.7 mg, packaged in 120-ct bottles (NDC 11789-257-10), Lloyd, Shenandoah, IA. ","Lot:: KD33611, Exp date: Sep-13 and Lot:: KD33611A, Exp date: Sep-13 ",".","10,172/120-ct bottles","The product Lot number and/or Expiration Date may be illegible or may be erased.",4/4/2013,"04/04/2013",5/15/2013,"05/15/2013"
"Veterinary",64920,"Ongoing","Lloyd Inc. of Iowa","Shenandoah","IA","US","Voluntary: Firm Initiated","Letter","Distribution was made nationwide, including Puerto Rico, Guatemala and Israel. Specific distribution will be reported.","V-152-2013","Class III","Lloyd Thyro-Tabs, levothyroxine sodium tablets, USP, 0.4 mg, packaged in 120-ct bottles (NDC 11789-254-10), Lloyd, Shenandoah, IA. ","Lot:: KB33611, Exp date: Sep-13; Lot: KB33611A, Exp date: Sep-13",".","12,632/120-ct bottles","The product Lot number and/or Expiration Date may be illegible or may be erased.",4/4/2013,"04/04/2013",5/15/2013,"05/15/2013"
"Food",64923,"Terminated","Jans Enterprises Corp. dba WIRA Corp.","Pomona","CA","US","Voluntary: Firm Initiated","Letter","Nationwide in the US","F-1346-2013","Class II","Jasmine Brand Garlic Flavored Crackers (Krupuk Bawang), 40x250gr.","JS-C3029",".","75 cases","Wira Corp. is recalling Jasmine Garlic Flavored Crackers because of undeclared colors FD& C Blue#1, FD & C Yellow # 5 , FD&C Yellow #6 and unapproved food color ingredients Ponceau 4R, E124, (Acid Red 18). ",3/1/2013,"03/01/2013",5/1/2013,"05/01/2013"
"Drugs",64924,"Ongoing","Mylan Pharmaceuticals Inc.","Morgantown","WV","US","Voluntary: Firm Initiated","Letter","Nationwide.","D-269-2013","Class III","Lisinopril Tablets, USP 10 mg, Rx only, 1000 count bottles, Manufactured for: Mylan Pharmaceuticals Inc ,Morgantown, WV 26505 U.S.A. Made in India; NDC 0378-20740-10","Lot# 3002450; exp 8/14",".","2,405 bottles ","Tablets/Capsules Imprinted With Wrong ID: Pharmaceuticals are imprinted with an incorrect identifier code on the embossed tablets..",2/26/2013,"02/26/2013",5/1/2013,"05/01/2013"
"Food",64925,"Ongoing","Meijer Distribution, Inc","Grand Rapids","MI","US","Voluntary: Firm Initiated","E-Mail","Meijer Distribution Centers and Retail Stores: Illinois, Indiana, Kentucky, Michigan, and Ohio","F-1348-2013","Class II","Meijer Essential M with Real Strawberries, 12 oz."," UPC 8-86926-04565-9, Batch: 100425342; Best Before: 08/17/2013",".","1,080 units","The label does not identify all ingredients including a chocolate containing soy lecithin, a potential allergen. ",4/9/2013,"04/09/2013",5/1/2013,"05/01/2013"
"Food",64926,"Ongoing","Whole Foods Market","Austin","TX","US","Voluntary: Firm Initiated","E-Mail","Nationwide","F-1725-2013","Class II","365 Organic 100% Apple Juice from concentrate with Vitamin C and Calcium in 6.75 fl oz (UPC 0 99482 42095 6) and 64 fl oz. (UPC 0 99482 42096 3) Distributed by: Whole Foods Market, Austin, TX 78703; 8 units peer shipping case","6.75 fl oz (UPC 0 99482 42095 6) - Expiration dates 2/14/2014 & 02/15/2014; 64 oz (UPC 0 99482 42096 3) - Expiration dates 1/15/2014, 1/29/2014, 2/12/2014, 2/18/2014, 2/27/2014, 3/11/2014, and 3/25/2014.",,"39,056 of the 64 oz and 23,576 of the 4pk/6.75 oz","Elevated patulin levels.",4/11/2013,"04/11/2013",7/31/2013,"07/31/2013"
"Devices",64927,"Completed","Kreg Medical Inc.","Chicago","IL","US","Voluntary: Firm Initiated","Visit","Nationwide Distribution including IL and IN.","Z-1480-2013","Class II","E-Z WIDER BARIATRIC CHAIR BED; Single Motion Expandable Width Technology","Models ASM100100 and ASM100104; Lot 1 (Blue Beds) Serian Numbers: KM100101, KM100102, KM100103, KM100104, KM100105, KM100106, KM100107, KM100108, KM100209, KM100100; Lot 2 (White Beds) Serial Numbers: KM100109, KM100111, KM100112, KM100113, KM100114, KM100115, KM100116, KM100117, KM100118, KM100119, KM100120; Lot 3 (White Beds) Serial Numbers: KM100144, KM100145, KM100146, KM100147, KM100148, KM100149, KM100150, KM100151, KM100152, KM100153, KM100154, KM100155, KM100156, KM100156, KM100157, KM1000158; Lot 4: (White Beds) Serial Numbers: KM100194, KM100195, KM100196, KM100197, KM100198, KM100199, KM100200, KM100201, KM100202, KM100203, KM100204, KM100205, KM100206, KM100207, KM100208; Lot 5: (White Beds) Serial Numbers: KM100211, KM100212, KM100213, KM100214, KM100215, KM100216, KM100217, KM100218",".","59 beds","An EZ Wider bed (capacity of 1000 lb. safe working load collapsed during patient use, leaving the patient in a forward tilt position.",8/2/2012,"08/02/2012",6/12/2013,"06/12/2013"
"Drugs",64929,"Ongoing","Total Resources Intl"," City of Industry","CA","US","Voluntary: Firm Initiated","E-Mail","Nationwide","D-890-2013","Class II","Medi-First Brand First Aid Kit, MEDI-FIRST 61 Piece Kit, Home, Workplace Travel, Sport, Total Resources International, Walnut, CA 91789 ","Lot 11214-07 ",,,"CGMP Deviations: The first aid kits that are subject to the voluntary recall is being initiated due to failure in stability testing of the active ingredient Benzalkonium Chloride.",4/9/2013,"04/09/2013",8/21/2013,"08/21/2013"
"Drugs",64929,"Ongoing","Total Resources Intl"," City of Industry","CA","US","Voluntary: Firm Initiated","E-Mail","Nationwide","D-889-2013","Class II","3M Tekk Brand Industrial/Construction First Aid Kit, Total Resources Int'l Walnut, CA 91789 ","Lot 11215-05,11216-05, 11216-06, 11217-05 ",,,"CGMP Deviations: The first aid kits that are subject to the voluntary recall is being initiated due to failure in stability testing of the active ingredient Benzalkonium Chloride.",4/9/2013,"04/09/2013",8/21/2013,"08/21/2013"
"Drugs",64929,"Ongoing","Total Resources Intl"," City of Industry","CA","US","Voluntary: Firm Initiated","E-Mail","Nationwide","D-891-2013","Class II","(No Brand) First Aid Kit, 326 Piece Kit. Product labeling reads in part: BE SMART GET PREPARED,326 Pieces of Name Brand & Quality First Aid Supplies, FIRST AID, Total Resources International, Walnut, CA 91789","Item Number 20-HBC-01015CCREV1.",,,"CGMP Deviations: The first aid kits that are subject to the voluntary recall is being initiated due to failure in stability testing of the active ingredient Benzalkonium Chloride.",4/9/2013,"04/09/2013",8/21/2013,"08/21/2013"
"Devices",64930,"Ongoing","Roche Molecular Systems, Inc.","Branchburg","NJ","US","Voluntary: Firm Initiated","Letter","Nationwide Distribution.","Z-1346-2013","Class II","cobas 4800 system z480 instrument. Integrates fully automated total nucleic acid isolation directly from secondary sample tubes.","Material Number 05200881001 - all lot/serial numbers.",".","425 instruments","In rare instances, channel shifted results have been generated with cobas 4800 assays run on v1.1.1 of the cobas 4800 system. Raw data review indicates that, in these cases, all signals are shifted by one channel: channel 1 results report as channel 2, channel 2 results report as channel 3, channel 3 results report as channel 4, and channel 4 results report as channel 1. In the reported cases, the results of the runs were either invalid or the preponderance of individual patient specimen showed to be invalid.",4/1/2013,"04/01/2013",5/29/2013,"05/29/2013"
"Devices",64931,"Ongoing","Progressive Medical Inc","Saint Louis","MO","US","Voluntary: Firm Initiated","Letter","Nationwide Distribution including AR, AZ, CA, CO, FL, ID, IL, IN, KS, KY, LA, MA, MI, MN, MO, NE, OH, OK, OR, TN, TX, WA, and WI.","Z-1362-2013","Class II","Progressive Medical PTFE Coated Disposable Electrosurgical Electrodes - NON-STICK CAUTERY TIP PTFE Coated Sharp Needle 2.00'' (5.08cm) Length, Product number P0118 Rx Only. Sterilized by Radiation. Manufactured for Progressive Medical, Inc., St. Louis, MO 63128. Electrodes used in Electrosurgeries","Lot number 082712-15",".","18 boxes with 12 units each.","Product coatings require 510K approval.",4/12/2013,"04/12/2013",5/29/2013,"05/29/2013"
"Devices",64931,"Ongoing","Progressive Medical Inc","Saint Louis","MO","US","Voluntary: Firm Initiated","Letter","Nationwide Distribution including AR, AZ, CA, CO, FL, ID, IL, IN, KS, KY, LA, MA, MI, MN, MO, NE, OH, OK, OR, TN, TX, WA, and WI.","Z-1354-2013","Class II","Progressive Medical PTFE Coated Disposable Electrosurgical Electrodes - NON-STICK CAUTERY TIP PTFE Modified Coated Blade 2.50'' (6.40cm) Length, Product number P0012M Rx Only. Sterilized by Radiation. Manufactured for Progressive Medical, Inc., St. Louis, MO 63128. Electrodes used in Electrosurgeries","Lot number 082712-02",".","20 boxes with 12 units each.","Product coatings require 510K approval.",4/12/2013,"04/12/2013",5/29/2013,"05/29/2013"
"Devices",64931,"Ongoing","Progressive Medical Inc","Saint Louis","MO","US","Voluntary: Firm Initiated","Letter","Nationwide Distribution including AR, AZ, CA, CO, FL, ID, IL, IN, KS, KY, LA, MA, MI, MN, MO, NE, OH, OK, OR, TN, TX, WA, and WI.","Z-1356-2013","Class II","Progressive Medical PTFE Coated Disposable Electrosurgical Electrodes -NON-STICK CAUTERY TIP PTFE Modified Coated Blade 6.5'' (16.51cm) Length, Product number P0014M Rx Only. Sterilized by Radiation. Manufactured for Progressive Medical, Inc., St. Louis, MO 63128. Electrodes used in Electrosurgeries","Lot number 082712-04",".","27 boxes with 12 units each.","Product coatings require 510K approval.",4/12/2013,"04/12/2013",5/29/2013,"05/29/2013"
"Devices",64931,"Ongoing","Progressive Medical Inc","Saint Louis","MO","US","Voluntary: Firm Initiated","Letter","Nationwide Distribution including AR, AZ, CA, CO, FL, ID, IL, IN, KS, KY, LA, MA, MI, MN, MO, NE, OH, OK, OR, TN, TX, WA, and WI.","Z-1357-2013","Class II","Progressive Medical PTFE Coated Disposable Electrosurgical Electrodes - Laparoscopic Electrode PTFE Coated Spatula 33cm Length, Product number P0018 Rx Only. Sterilized by Radiation. Manufactured for Progressive Medical, Inc., St. Louis, MO 63128. Electrodes used in Electrosurgeries","Lot number 082712-05",".","16 boxes with 6 units each.","Product coatings require 510K approval.",4/12/2013,"04/12/2013",5/29/2013,"05/29/2013"
"Devices",64931,"Ongoing","Progressive Medical Inc","Saint Louis","MO","US","Voluntary: Firm Initiated","Letter","Nationwide Distribution including AR, AZ, CA, CO, FL, ID, IL, IN, KS, KY, LA, MA, MI, MN, MO, NE, OH, OK, OR, TN, TX, WA, and WI.","Z-1364-2013","Class II","Progressive Medical PTFE Coated Disposable Electrosurgical Electrodes - Push Button Pencil With PTFE Blade and Holster, Product number P0035H Sterilized by Radiation. Manufactured for Progressive Medical, Inc., St. Louis, MO 63128. Rx Only Electrodes used in Electrosurgeries","Lot number 082712-12",".","11 boxes with 25 units each.","Product coatings require 510K approval.",4/12/2013,"04/12/2013",5/29/2013,"05/29/2013"
"Devices",64931,"Ongoing","Progressive Medical Inc","Saint Louis","MO","US","Voluntary: Firm Initiated","Letter","Nationwide Distribution including AR, AZ, CA, CO, FL, ID, IL, IN, KS, KY, LA, MA, MI, MN, MO, NE, OH, OK, OR, TN, TX, WA, and WI.","Z-1351-2013","Class II","Progressive Medical PTFE Coated Disposable Electrosurgical Electrodes - NON-STICK CAUTERY TIP PTFE Coated Blade 2.50'' (6.40) Length, Product number P0012, Rx Only. Sterilized by Radiation. Manufactured for Progressive Medical, Inc., St. Louis, MO 63128. Electrodes used in Electrosurgeries","Lot numbers 071212-01, 082712-01 and 111212-04",".","150 boxes with 12 units each.","Product coatings require 510K approval.",4/12/2013,"04/12/2013",5/29/2013,"05/29/2013"
"Devices",64931,"Ongoing","Progressive Medical Inc","Saint Louis","MO","US","Voluntary: Firm Initiated","Letter","Nationwide Distribution including AR, AZ, CA, CO, FL, ID, IL, IN, KS, KY, LA, MA, MI, MN, MO, NE, OH, OK, OR, TN, TX, WA, and WI.","Z-1355-2013","Class II","Progressive Medical PTFE Coated Disposable Electrosurgical Electrodes -Laparoscopic Electrode PTFE Coated Curved Blade 33cm Length, Product number P0019 Rx Only. Sterilized by Radiation. Manufactured for Progressive Medical, Inc., St. Louis, MO 63128. Electrodes used in Electrosurgeries","Lot number 071212-04",".","38 boxes with 6 units each.","Product coatings require 510K approval.",4/12/2013,"04/12/2013",5/29/2013,"05/29/2013"
"Devices",64931,"Ongoing","Progressive Medical Inc","Saint Louis","MO","US","Voluntary: Firm Initiated","Letter","Nationwide Distribution including AR, AZ, CA, CO, FL, ID, IL, IN, KS, KY, LA, MA, MI, MN, MO, NE, OH, OK, OR, TN, TX, WA, and WI.","Z-1359-2013","Class II","Progressive Medical PTFE Coated Disposable Electrosurgical Electrodes - Laparoscopic Electrode PTFE Coated Wire L Hook Split 33cm Length,Product number P0020S Rx Only. Sterilized by Radiation. Manufactured for Progressive Medical, Inc., St. Louis, MO 63128. Electrodes used in Electrosurgeries","Lot number 082712-07",".","20 boxes with 6 units each.","Product coatings require 510K approval.",4/12/2013,"04/12/2013",5/29/2013,"05/29/2013"
"Devices",64931,"Ongoing","Progressive Medical Inc","Saint Louis","MO","US","Voluntary: Firm Initiated","Letter","Nationwide Distribution including AR, AZ, CA, CO, FL, ID, IL, IN, KS, KY, LA, MA, MI, MN, MO, NE, OH, OK, OR, TN, TX, WA, and WI.","Z-1363-2013","Class II","Progressive Medical PTFE Coated Disposable Electrosurgical Electrodes - Laparoscopic Electrode PTFE Coated J- Hook 44cm Length, Product number P0021X Rx Only. Sterilized by Radiation. Manufactured for Progressive Medical, Inc., St. Louis, MO 63128. Electrodes used in Electrosurgeries","Lot number 082712-10",".","4 boxes containing 6 individually packaged pieces each","Product coatings require 510K approval.",4/12/2013,"04/12/2013",5/29/2013,"05/29/2013"
"Devices",64931,"Ongoing","Progressive Medical Inc","Saint Louis","MO","US","Voluntary: Firm Initiated","Letter","Nationwide Distribution including AR, AZ, CA, CO, FL, ID, IL, IN, KS, KY, LA, MA, MI, MN, MO, NE, OH, OK, OR, TN, TX, WA, and WI.","Z-1349-2013","Class II","Progressive Medical PTFE Coated Disposable Electrosurgical Electrodes - NON-STICK CAUTERY TIP PTFE Coated Blade 6.5'' (16.51cm) Length, Product number P0014, Rx Only. Sterilized by Radiation. Manufactured for Progressive Medical, Inc., St. Louis, MO 63128. Electrodes used in Electrosurgeries","Lot number 071212-03",".","19 boxes with 12 units each.","Product coatings require 510K approval.",4/12/2013,"04/12/2013",5/29/2013,"05/29/2013"
"Devices",64931,"Ongoing","Progressive Medical Inc","Saint Louis","MO","US","Voluntary: Firm Initiated","Letter","Nationwide Distribution including AR, AZ, CA, CO, FL, ID, IL, IN, KS, KY, LA, MA, MI, MN, MO, NE, OH, OK, OR, TN, TX, WA, and WI.","Z-1348-2013","Class II","Progressive Medical PTFE Coated Disposable Electrosurgical Electrodes - NON-STICK CAUTERY TIP PTFE Modified Coated Needle 2.75'' (6.99cm) Length, Product number P0013M, Rx Only. Sterilized by Radiation. Manufactured for Progressive Medical, Inc., St. Louis, MO 63128. Electrodes used in Electrosurgeries","Lot number 071212-02",".","28 boxes with 12 units each.","Product coatings require 510K approval.",4/12/2013,"04/12/2013",5/29/2013,"05/29/2013"
"Devices",64931,"Ongoing","Progressive Medical Inc","Saint Louis","MO","US","Voluntary: Firm Initiated","Letter","Nationwide Distribution including AR, AZ, CA, CO, FL, ID, IL, IN, KS, KY, LA, MA, MI, MN, MO, NE, OH, OK, OR, TN, TX, WA, and WI.","Z-1352-2013","Class II","Progressive Medical PTFE Coated Disposable Electrosurgical Electrodes - Laparoscopic Electrode PTFE Coated Wire L Hook 33cm Length, Product number P0100 Rx Only. Sterilized by Radiation. Manufactured for Progressive Medical, Inc., St. Louis, MO 63128. Electrodes used in Electrosurgeries","Lot numbers 071212-06 and 082712-13",".","59 boxes with 6 units each.","Product coatings require 510K approval.",4/12/2013,"04/12/2013",5/29/2013,"05/29/2013"
"Devices",64931,"Ongoing","Progressive Medical Inc","Saint Louis","MO","US","Voluntary: Firm Initiated","Letter","Nationwide Distribution including AR, AZ, CA, CO, FL, ID, IL, IN, KS, KY, LA, MA, MI, MN, MO, NE, OH, OK, OR, TN, TX, WA, and WI.","Z-1358-2013","Class II","Progressive Medical PTFE Coated Disposable Electrosurgical Electrodes - Laparoscopic Electrode PTFE Coated Wire L Hook 44cm Length, Product number P0100X Rx Only. Sterilized by Radiation. Manufactured for Progressive Medical, Inc., St. Louis, MO 63128. Electrodes used in Electrosurgeries","Lot numbers 071212-07 and 082712-14",".","60 boxes with 6 units each.","Product coatings require 510K approval.",4/12/2013,"04/12/2013",5/29/2013,"05/29/2013"
"Devices",64931,"Ongoing","Progressive Medical Inc","Saint Louis","MO","US","Voluntary: Firm Initiated","Letter","Nationwide Distribution including AR, AZ, CA, CO, FL, ID, IL, IN, KS, KY, LA, MA, MI, MN, MO, NE, OH, OK, OR, TN, TX, WA, and WI.","Z-1350-2013","Class II","Progressive Medical PTFE Coated Disposable Electrosurgical Electrodes - Laparoscopic Electrode PTFE Coated L Hook 33cm Length, Product number P0020, Rx Only. Sterilized by Radiation. Manufactured for Progressive Medical, Inc., St. Louis, MO 63128. Electrodes used in Electrosurgeries","Lot numbers 071212-05 and 081712-06",".","173 boxes with 6 units each.","Product coatings require 510K approval.",4/12/2013,"04/12/2013",5/29/2013,"05/29/2013"
"Devices",64931,"Ongoing","Progressive Medical Inc","Saint Louis","MO","US","Voluntary: Firm Initiated","Letter","Nationwide Distribution including AR, AZ, CA, CO, FL, ID, IL, IN, KS, KY, LA, MA, MI, MN, MO, NE, OH, OK, OR, TN, TX, WA, and WI.","Z-1361-2013","Class II","Progressive Medical PTFE Coated Disposable Electrosurgical Electrodes - NON-STICK CAUTERY TIP PTFE Coated Needle 2.75'' (6.99cm) Length, Product number P0013 Rx Only. Sterilized by Radiation. Manufactured for Progressive Medical, Inc., St. Louis, MO 63128. Electrodes used in Electrosurgeries","Lot number 082712-03",".","39 boxes with 12 units each.","Product coatings require 510K approval.",4/12/2013,"04/12/2013",5/29/2013,"05/29/2013"
"Devices",64931,"Ongoing","Progressive Medical Inc","Saint Louis","MO","US","Voluntary: Firm Initiated","Letter","Nationwide Distribution including AR, AZ, CA, CO, FL, ID, IL, IN, KS, KY, LA, MA, MI, MN, MO, NE, OH, OK, OR, TN, TX, WA, and WI.","Z-1360-2013","Class II","Progressive Medical PTFE Coated Disposable Electrosurgical Electrodes - Laparoscopic Electrode PTFE Coated J Hook 33cm Length, Product number P0021, Rx Only. Sterilized by Radiation. Manufactured for Progressive Medical, Inc., St. Louis, MO 63128. Electrodes used in Electrosurgeries","Lot number 082712-09",".","19 boxes with 6 units each.","Product coatings require 510K approval.",4/12/2013,"04/12/2013",5/29/2013,"05/29/2013"
"Devices",64931,"Ongoing","Progressive Medical Inc","Saint Louis","MO","US","Voluntary: Firm Initiated","Letter","Nationwide Distribution including AR, AZ, CA, CO, FL, ID, IL, IN, KS, KY, LA, MA, MI, MN, MO, NE, OH, OK, OR, TN, TX, WA, and WI.","Z-1353-2013","Class II","Progressive Medical PTFE Coated Disposable Electrosurgical Electrodes - Laparoscopic Electrode PTFE Coated L Hook 44cm Length, Product number P0020X Rx Only. Sterilized by Radiation. Manufactured for Progressive Medical, Inc., St. Louis, MO 63128. Electrodes used in Electrosurgeries","Lot number 082712-08",".","20 boxes with 6 units each.","Product coatings require 510K approval.",4/12/2013,"04/12/2013",5/29/2013,"05/29/2013"
"Drugs",64933,"Ongoing","OPMX, LLC","San Diego","CA","US","Voluntary: Firm Initiated","Letter","Nationwide","D-300-2013","Class II","Pentrexcilina Jarabe NF (dextromethorphan HBr and guaifenesin) liquid, 118 mL/ 4 fl oz bottle, Distributed by Laboratorios Nordimex Co., San Diego, CA 92154, UPC 0 91965 02001 1.","Lot #: 11649A0, Exp 12/13",".","7,610 bottles","Labeling: Not Elsewhere Classified: Pentrexcilina Tablets and Pentrexcilina Liquid are being recalled because the product labels are misleading because they may be confused with Pentrexyl, a prescription antibiotic used to treat respiratory illnesses in Mexico.",4/12/2013,"04/12/2013",5/1/2013,"05/01/2013"
"Drugs",64933,"Ongoing","OPMX, LLC","San Diego","CA","US","Voluntary: Firm Initiated","Letter","Nationwide","D-299-2013","Class II","Pentrexcilina (acetaminophen, chlorpheniramine maleate, and phenylephrine HCl) tablets, 20-count tablets per carton, Distributed by: Laboratorios Norimex Co., San Diego, CA 92154, UPC 0 91965 02002 8.","Lot #: 11611B0, Batch # 114039, Exp 10/14",".","11,580 cartons","Labeling: Not Elsewhere Classified: Pentrexcilina Tablets and Pentrexcilina Liquid are being recalled because the product labels are misleading because they may be confused with Pentrexyl, a prescription antibiotic used to treat respiratory illnesses in Mexico.",4/12/2013,"04/12/2013",5/1/2013,"05/01/2013"
"Devices",64935,"Ongoing","Olympus America Inc.","Center Valley","PA","US","Voluntary: Firm Initiated","Letter","Nationwide Distribution - USA Nationwide including the states of: AL, AR, AZ, CA, CO, CT, DE, FL, GA, IA, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, NE, NH, NJ, NV, NY, OH, OR, PA, RI, SC, TN, TX, UT, VA, WA, WV, and WY.","Z-1277-2013","Class II","Olympus SurgMaster UES-40 electrosurgical unit (''UES-40'') Product Usage: Designed for use in a medical facility under the supervision of a trained physician. It has been designed for general (open) and endoscopic surgery including urology, gynecology, respiratory and gastroenterology in conjunction with Olympus designed electrosurgical accessories, endoscopes (fiberscopes, videoscopes and rigid scopes) applicable for electrosurgery (cutting and coagulation), light sources and other ancillary equipment.","Model UES-40, all serial numbers prior to 7925334 that have not been upgraded.",".","608","Olympus initiated a software upgrade and enhancement in 2009 and completed the action in 2010. The upgrade and enhancement were initiated due to complaints of overheating, smoke vapors and failure to operate associated with the Olympus SurgMaster electrosurgical unit, model UES-40 (''UES-40'') when used in conjunction with the Olympus WA22557C electrode. The complaint investigations revealed that some users were exceeding the maximum output time beyond the timeframes specified in the labeling. Exceeding the maximum output time can cause the UES-40 to overheat thereby causing the unit to stop working and produce smoke vapors. ",11/10/2009,"11/10/2009",5/15/2013,"05/15/2013"
"Drugs",64936,"Ongoing","Sandoz Incorporated","Broomfield","CO","US","Voluntary: Firm Initiated","Letter","Nationwide","D-268-2013","Class II","Amoxicillin Capsules USP 500 mg, Manufactured in Austria by Sandoz GmbH for Sandoz Inc., Princeton, NJ 08540, Rx only. Manufactured in 500 ct (NDC 0781-2613-05) and 30 ct (NDC 0781-2613-31) bottles.","CK2003, CK2004 exp. 04/15, CR4110, CR4111, CS2983, CS2986, CS2988, CS2989, CS2990, CS2991, CS2992, CS2993, CS2994 exp. 07/15, CK3616, CK3617 exp. 04/15",".","8286 x 30 ct, 37108 x 500 ct. bottles","Presence of Foreign Substance, Sandoz is recalling certain lots of Amoxicillin Capsules, USP 500 mg due to potential contamination with fragments of stainless steel wire mesh.",4/18/2013,"04/18/2013",5/1/2013,"05/01/2013"
"Devices",64937,"Ongoing","DePuy Spine, Inc.","Raynham","MA","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution - USA (nationwide) including AR, AZ, CA, CO, CT, FL, GA, HI, IA, ID, IN, KY, LA, MA, MD, MI, MN, MO, NC, NE, NJ, NY, OH, OK, OR, PA, SC, TN, TX, VA, WA, WV and WY; and internationally to: Algeria, Australia, Austria, Belgium, Brazil, Canada, Colombia, Cyprus, Czech Republic, France, Germany, Hong Kong, India, Israel, Italy, Latvia, Luxembourg, Malaysia, Mexico, Netherlands, Norway, Poland, Portugal, Singapore, Slovenia, South Africa, Spain, Sweden, Switzerland, Turkey, UAE and UK.","Z-2133-2013","Class II","CONFIDENCE SPINAL CEMENT SYSTEM 11CC PLUS KIT, Product Code: 2839-10-000 The CONFIDENCE Spinal Cement System is intended for percutaneous delivery of CONFIDENCE Spinal Cement, which is indicated for fixation of pathological fractures of the vertebral body during vertebroplasty or kyphoplasty procedures","HPBB0K, HPBB3C,HPCB7J, HPDBD6, HPBB0L,HPBB3D,HPCB7W,HPDBF0, HPBB0M,HPBB3F,HPDBBC,HPDBG4, HPBB0N,HPBBWH,HPDBBD,HPDBGB, HPBB0P,HPBBWJ,HPDBBK,HPDBGC,HPBB0T,HPBBWL,HPDBBL,HPDBGJ, HPBB19,HPBBZ8,HPDBBY,HPDBGM,HPBB27,HPBBZD,HPDBCD,HPDBGN, HPBB29,HPBBZN,HPDBCF, HPDBGY,HPBB2B,HPCB7B,HPDBD0,HPBB2C, HPCB7C,HPDBD3,HPBB2G,HPCB7H,HPDBD4",".","3896 units (Overall quantity distributed appears greater than quantities manufactured due to the distribution pathways)","During injection of cement, the water in the hydraulic pump leaks past the piston within the pump body resulting in the loss of pressure and inability to continue to inject cement.",4/17/2013,"04/17/2013",9/11/2013,"09/11/2013"
"Devices",64937,"Ongoing","DePuy Spine, Inc.","Raynham","MA","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution - USA (nationwide) including AR, AZ, CA, CO, CT, FL, GA, HI, IA, ID, IN, KY, LA, MA, MD, MI, MN, MO, NC, NE, NJ, NY, OH, OK, OR, PA, SC, TN, TX, VA, WA, WV and WY; and internationally to: Algeria, Australia, Austria, Belgium, Brazil, Canada, Colombia, Cyprus, Czech Republic, France, Germany, Hong Kong, India, Israel, Italy, Latvia, Luxembourg, Malaysia, Mexico, Netherlands, Norway, Poland, Portugal, Singapore, Slovenia, South Africa, Spain, Sweden, Switzerland, Turkey, UAE and UK.","Z-2134-2013","Class II","CONFIDENCE SPINAL CEMENT SYSTEM KIT, Product Code: 2839-13-000 The CONFIDENCE Spinal Cement System is intended for percutaneous delivery of CONFIDENCE Spinal Cement, which is indicated for fixation of pathological fractures of the vertebral body during vertebroplasty or kyphoplasty procedures. ","HPBB0B, HPBBWM, HPCB75, HPCCBN, HPBB0R, HPBBWP, HPCB7D, HPDBBV, HPBB28, HPBBZ7, HPCB7F, HPDBCG, HPBB2D, HPBBZF, HPCB7T, HPDBD1, HPBB2F, HPBCKH, HPCB7V, HPDBD5, HPBB4R, HPBDL9, HPCB8G, HPDBF9, HPBBV1, HPCB67, HPCBLC, HPDBGH, HPBBWG, HPCB68, HPCBM1, HPDBGK, HPBBWK, HPCB74, HPCCBM, HPDBGL",".","3896 units (Overall quantity distributed appears greater than quantities manufactured due to the distribution pathways)","During injection of cement, the water in the hydraulic pump leaks past the piston within the pump body resulting in the loss of pressure and inability to continue to inject cement.",4/17/2013,"04/17/2013",9/11/2013,"09/11/2013"
"Devices",64937,"Ongoing","DePuy Spine, Inc.","Raynham","MA","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution - USA (nationwide) including AR, AZ, CA, CO, CT, FL, GA, HI, IA, ID, IN, KY, LA, MA, MD, MI, MN, MO, NC, NE, NJ, NY, OH, OK, OR, PA, SC, TN, TX, VA, WA, WV and WY; and internationally to: Algeria, Australia, Austria, Belgium, Brazil, Canada, Colombia, Cyprus, Czech Republic, France, Germany, Hong Kong, India, Israel, Italy, Latvia, Luxembourg, Malaysia, Mexico, Netherlands, Norway, Poland, Portugal, Singapore, Slovenia, South Africa, Spain, Sweden, Switzerland, Turkey, UAE and UK.","Z-2132-2013","Class II","CONFIDENCE SPINAL CEMENT SYSTEM 5CC KIT, Product Code: 2839-05-000 The CONFIDENCE Spinal Cement System is intended for percutaneous delivery of CONFIDENCE Spinal Cement, which is indicated for fixation of pathological fractures of the vertebral body during vertebroplasty or kyphoplasty procedures.","HPBBZP, HPDBFZ",".","3896 units (Overall quantity distributed appears greater than quantities manufactured due to the distribution pathways)","During injection of cement, the water in the hydraulic pump leaks past the piston within the pump body resulting in the loss of pressure and inability to continue to inject cement.",4/17/2013,"04/17/2013",9/11/2013,"09/11/2013"
"Biologics",64938,"Terminated","CSL Plasma, Inc.","Oklahoma City","OK","US","Voluntary: Firm Initiated","Other","Germany","B-1797-13","Class II","Source Plasma","42203722165; ",".","1","Blood product, tested for viral markers using a sample that was diluted with saline, was distributed.",2/28/2013,"02/28/2013",7/24/2013,"07/24/2013"
"Devices",64941,"Ongoing","Stryker Howmedica Osteonics Corp.","Mahwah","NJ","US","Voluntary: Firm Initiated","Letter","Nationwide distribution: USA including states of: HI, IN, MS, NC, NJ, OK, TX, and WI.","Z-1370-2013","Class II","Stryker Orthopaedics Triathlon Femoral Distal Augment- Left; 1 single unit per package Howmedica Osteonics Corp. 325 Corporate Drive, Mahwah, NJ 07430 USA Stryker France, ZAC Satolas Green Pusignan, Av de Satoles Green 69881 Meyzieu, Cedex, France This device is used when there is a deficiency in the bone present during femoral preparation these devices are used to ''fill the gap'' between the implant and the bone","Catalog Number 5541-A-501 Lot Codes HALY, HAOO, HANG",".","11 units","Stryker Orthopaedics received a report that a label on the external packaging (box) of a Triathalon Femoral Distal Augment 10mm- Size 5 Left depicted a glyph of an acetabular shell rather than a femoral distal augment. In addition the label was missing a reference to the ''10mm'' augment thickness which per the label print is required to appear below the size reference.",3/25/2013,"03/25/2013",5/29/2013,"05/29/2013"
"Devices",64942,"Ongoing","Stryker Howmedica Osteonics Corp.","Mahwah","NJ","US","Voluntary: Firm Initiated","Letter","Nationwide Distribution including the states of AL, AZ, IL, KY, LA, NJ, NC, FL, CA, NM, MO, TN, VA, CO, MA, TX, IN and MT.","Z-1210-2013","Class II","Stryker Howmedica Osteonics Corp. AxSOS System Instrument. The AxSOS Locking Plate System is designed to treat periarticular or intraarticular fractures of the Distal Femur, Proximal Humerus, Proximal Tibia, and the Distal Tibia. Per the operative technique, '' A 4.3 mm Drill (REF 702743) is then used to drill the core hole for the locking screw. Using a fluoroscopy, check the correct depth of the drill, and measure the length of the screw. The Drill Sleeve should now be removed, and the correct length 5.0 mm Locking Screw is inserted using the Screwdriver T20 and Screw Holding Sleeve.'' ","Catalog number 703615 ",,"107 units","Stryker Orthopaedics has received a report indicating that the scale of the AxSOS Calibrated Drill Bit 4.3,,X263mm, flat , manufactured by Stryker Osteosynthesis, is incorrect. The incorrect scale could result in the surgeon selecting a screw that is 10mm longer than intended.",3/28/2013,"03/28/2013",5/8/2013,"05/08/2013"
"Devices",64943,"Ongoing","Coloplast Manufacturing US, LLC","Minneapolis","MN","US","Voluntary: Firm Initiated","Letter","Nationwide Distribution including AL, CA, CO, DC, IL, IN, KY, MD, MA, MO, NH, OH, RI, and VA.","Z-1341-2013","Class II","Rostorelle L, Polypropylene Mesh, Catalog number 501440, Manufacturer Coloplast A/S 3050 Denmark.","3483171",".","111","Coloplast is recalling one lot of Restorelle L prosthesis because it is mislabeled. The incorrect Instructions For Use (IFU) pamphlet is included in the packaging.",4/12/2013,"04/12/2013",5/29/2013,"05/29/2013"
"Devices",64944,"Ongoing","Siemens Medical Solutions USA, Inc","Martinez","CA","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution - USA (nationwide) and internationally to Poland, India, Canada, Germany, United Kingdom, New Zealand, Belgium, Malaysia, Republic Korea, Ireland, Australia, Norway, Japan, Turkey, Croatia, Saudi Arabia, Colombia, P.R. China, Brazil, Thailand, Romania, Lebanon, Mexico, Italy, Sweden, Czech Republic, Russian Federation, and South Africa.","Z-1182-2013","Class II","Software correction applies to customers who use the RT Therapist RTT4.2.108 and RT Therapist Connect RTT 4.2.108 on Siemens ARTISTE, ONCOR and PRIMUS systems. ARTISTE, ONCOR and PRIMUS family of linear accelerators are used to deliver X-ray photon and electron radiation for the therapeutic treatment of cancer.","Syngo RT Therapist RTT 4.2.108; part number 8162815: Syngo ST Theratpist Connect RTT 4.2.108; part number 8168754",,"245 active devices","Software update to fix multiple safety related issues.",4/4/2013,"04/04/2013",5/8/2013,"05/08/2013"
"Food",64945,"Ongoing","Paleteria Y Neveria La Rosita, LLC","South Bend","IN","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Domestic: MI, IN retail stores","F-1365-2013","Class II","Vanilla Dessert Bar , 4 oz. Undeclared FD&C Yellow # 6 packaged in clear flexible plastic, ingredients: water, sugar, partially hydrogenated palm kernel oil, nonfat milk solids, corn syrup, whey powder, raisins....red 40, yellow 5 UPC Code 8 94163 00220 5","firm does not code products",,,"Product labeling is incorrect, FD&C colors are undeclared. ",4/6/2013,"04/06/2013",5/8/2013,"05/08/2013"
"Food",64945,"Ongoing","Paleteria Y Neveria La Rosita, LLC","South Bend","IN","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Domestic: MI, IN retail stores","F-1353-2013","Class II","Pineapple Fruit Bar, 4 oz. Undeclared FD&C Yellow # 6 and Red # 40 packaged in clear flexible plastic ingredients: water, pineapple, sugar, citric acid, yellow 5 UPC Code 8 94163 00210 6","firm does not code products",,,"Product labeling is incorrect, FD&C colors are undeclared. ",4/6/2013,"04/06/2013",5/8/2013,"05/08/2013"
"Food",64945,"Ongoing","Paleteria Y Neveria La Rosita, LLC","South Bend","IN","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Domestic: MI, IN retail stores","F-1359-2013","Class III","Watermelon Fruit Bar , 4 oz. Undeclared FD&C Blue # 1 packaged in clear flexible plastic ingredients: water, watermelon, sugar, red 40 UPC Code 8 94163 00210 6","firm does not code products",,,"Product labeling is incorrect, FD&C colors are undeclared. ",4/6/2013,"04/06/2013",5/8/2013,"05/08/2013"
"Food",64945,"Ongoing","Paleteria Y Neveria La Rosita, LLC","South Bend","IN","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Domestic: MI, IN retail stores","F-1360-2013","Class III","Pina Colada Dessert Bar , 4 oz. Undeclared FD&C Red # 40 in clear flexible plastic, ingredients: water, sugar, partially hydrogenated palm kernel oil, nonfat milk solids, cream of coconut, whey powder, ","firm does not code product",,,"Product labeling is incorrect, FD&C colors are undeclared. ",4/6/2013,"04/06/2013",5/8/2013,"05/08/2013"
"Food",64945,"Ongoing","Paleteria Y Neveria La Rosita, LLC","South Bend","IN","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Domestic: MI, IN retail stores","F-1361-2013","Class III","Strawberry Milk Dessert Bar , 4 oz. Undeclared FD&C Blue # 1 ingredients: water, sugar, partially hydrogenated palm kernel oil, nonfat milk solids, red 40, UPC Code 8 94163 00220 5","firm does not code product",,,"Product labeling is incorrect, FD&C colors are undeclared. ",4/6/2013,"04/06/2013",5/8/2013,"05/08/2013"
"Food",64945,"Ongoing","Paleteria Y Neveria La Rosita, LLC","South Bend","IN","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Domestic: MI, IN retail stores","F-1364-2013","Class III","Strawberry Eskimo Dessert Bar , 4 oz. Undeclared FD&C Blue # 1 packaged in clear flexible plastic, ingredients: water, chocolate coating (coconut oil, sugar, partially hydrogenated coconut and soybean oil, cocoa, corn starch, soy lecithin, etc.) red 40, UPC Code 8 94163 00230 4","firm does not code products",,,"Product labeling is incorrect, FD&C colors are undeclared. ",4/6/2013,"04/06/2013",5/8/2013,"05/08/2013"
"Food",64945,"Ongoing","Paleteria Y Neveria La Rosita, LLC","South Bend","IN","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Domestic: MI, IN retail stores","F-1355-2013","Class II","Vanilla Eskimo Dessert Bar , 4 oz. Undeclared FD&C Yellow # 6 in clear flexible package, ingredients: water, chocolate coating (coconut oil, sugar, partially hydrogenated coconut and soybean oil, cocoa, corn starch, soy lecithin, etc.) red 40, yellow 5 UPC Code 8 94163 00230 4","firm does not code products",,,"Product labeling is incorrect, FD&C colors are undeclared. ",4/6/2013,"04/06/2013",5/8/2013,"05/08/2013"
"Food",64945,"Ongoing","Paleteria Y Neveria La Rosita, LLC","South Bend","IN","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Domestic: MI, IN retail stores","F-1356-2013","Class II","Spicy Mango Dessert Bar , 4 oz. Undeclared FD&C Yellow # 6 and Blue # 1 in clear flexible plastic, ingredients: water, mango, sugar, lime juice, salt, citric acid, chili powder, yellow 5, red 40","firm does not code products",,,"Product labeling is incorrect, FD&C colors are undeclared. ",4/6/2013,"04/06/2013",5/8/2013,"05/08/2013"
"Food",64945,"Ongoing","Paleteria Y Neveria La Rosita, LLC","South Bend","IN","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Domestic: MI, IN retail stores","F-1354-2013","Class II","Mango Dessert Bar, 4 oz. Undeclared FD&C Yellow # 6 and Blue # 1 in clear flexible plastic. Ingredients: water, sugar, mango, partially hydrogenated palm kernel oil, nonfat milk solids UPC Code 8 94163 00220 5","firm does not code products",,,"Product labeling is incorrect, FD&C colors are undeclared. ",4/6/2013,"04/06/2013",5/8/2013,"05/08/2013"
"Food",64945,"Ongoing","Paleteria Y Neveria La Rosita, LLC","South Bend","IN","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Domestic: MI, IN retail stores","F-1357-2013","Class II","Spicy Cucumber Fruit Bar , 4 oz. Undeclared FD&C Yellow # 6 and Blue # 1 in clear flexible plastic ingredients: water, cucumber, sugar, orange juice, lime juice, salt, citric acid, chili powder, yellow 5, red 40 UPC Code 8 94163 00210 6","firm does not code products",,,"Product labeling is incorrect, FD&C colors are undeclared. ",4/6/2013,"04/06/2013",5/8/2013,"05/08/2013"
"Food",64945,"Ongoing","Paleteria Y Neveria La Rosita, LLC","South Bend","IN","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Domestic: MI, IN retail stores","F-1363-2013","Class III","Strawberry Fruit Bar , 4 oz. Undeclared FD&C Blue # 1 ingredients: water, strawberries, sugar, citric acid, red 40 UPC Code 8 94163 00210 6","firm does not code products",,,"Product labeling is incorrect, FD&C colors are undeclared. ",4/6/2013,"04/06/2013",5/8/2013,"05/08/2013"
"Food",64945,"Ongoing","Paleteria Y Neveria La Rosita, LLC","South Bend","IN","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Domestic: MI, IN retail stores","F-1358-2013","Class III","Guava Fruit Bar , 4 oz. Undeclared FD&C Red # 40 in clear flexible plastic, ingredients: water, guava fruit, sugar, tumeric, blue 1, UPC Code 8 94163 00210 6","firm does not code products",,,"Product labeling is incorrect, FD&C colors are undeclared. ",4/6/2013,"04/06/2013",5/8/2013,"05/08/2013"
"Food",64945,"Ongoing","Paleteria Y Neveria La Rosita, LLC","South Bend","IN","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Domestic: MI, IN retail stores","F-1362-2013","Class III","Bubble Gum Frozen Dessert Bar , 4 oz. Undeclared FD&C Red # 3 packaged in clear flexible plastic, ingredients: water, sugar, citric acid, blue 1 UPC Code 8 94163 00210 6","firm does not code products",,,"Product labeling is incorrect, FD&C colors are undeclared. ",4/6/2013,"04/06/2013",5/8/2013,"05/08/2013"
"Biologics",64946,"Terminated","Central California Blood Center","Fresno","CA","US","Voluntary: Firm Initiated","Other","Switzerland; California","B-1777-13","Class II","Blood and Blood Products for Reprocessing","W115911282177; ",".","1","Blood products, collected from a donor considered to be at increased risk for variant Creutzfeldt-Jakob Disease (vCJD), were distributed. ",4/5/2013,"04/05/2013",7/24/2013,"07/24/2013"
"Biologics",64946,"Terminated","Central California Blood Center","Fresno","CA","US","Voluntary: Firm Initiated","Other","Switzerland; California","B-1778-13","Class II","Red Blood Cells Leukocytes Reduced","W115911282177; ",".","1","Blood products, collected from a donor considered to be at increased risk for variant Creutzfeldt-Jakob Disease (vCJD), were distributed. ",4/5/2013,"04/05/2013",7/24/2013,"07/24/2013"
"Biologics",64955,"Terminated","South Texas Blood & Tissue Center","San Antonio","TX","US","Voluntary: Firm Initiated","FAX","Texas","B-1774-13","Class II","Fresh Frozen Plasma","W140912138630; 2488230; ",".","2","Blood products, collected from a donor considered to be at increased risk for variant Creutzfeldt-Jakob Disease (vCJD), were distributed. ",2/6/2013,"02/06/2013",7/24/2013,"07/24/2013"
"Biologics",64955,"Terminated","South Texas Blood & Tissue Center","San Antonio","TX","US","Voluntary: Firm Initiated","FAX","Texas","B-1772-13","Class II","Red Blood Cells (Apheresis) Leukocytes Reduced","7188318; ",".","1","Blood products, collected from a donor considered to be at increased risk for variant Creutzfeldt-Jakob Disease (vCJD), were distributed. ",2/6/2013,"02/06/2013",7/24/2013,"07/24/2013"
"Biologics",64955,"Terminated","South Texas Blood & Tissue Center","San Antonio","TX","US","Voluntary: Firm Initiated","FAX","Texas","B-1776-13","Class III","Platelets","2488230; ",".","1","Blood products, collected from a donor considered to be at increased risk for variant Creutzfeldt-Jakob Disease (vCJD), were distributed. ",2/6/2013,"02/06/2013",7/24/2013,"07/24/2013"
"Biologics",64955,"Terminated","South Texas Blood & Tissue Center","San Antonio","TX","US","Voluntary: Firm Initiated","FAX","Texas","B-1775-13","Class II","Red Blood Cells Leukocytes Reduced","W140912138630; 2488230; ",".","2","Blood products, collected from a donor considered to be at increased risk for variant Creutzfeldt-Jakob Disease (vCJD), were distributed. ",2/6/2013,"02/06/2013",7/24/2013,"07/24/2013"
"Biologics",64955,"Terminated","South Texas Blood & Tissue Center","San Antonio","TX","US","Voluntary: Firm Initiated","FAX","Texas","B-1773-13","Class II","Platelets Pheresis Leukocytes Reduced Irradiated","7188318; ",".","1","Blood products, collected from a donor considered to be at increased risk for variant Creutzfeldt-Jakob Disease (vCJD), were distributed. ",2/6/2013,"02/06/2013",7/24/2013,"07/24/2013"
"Veterinary",64956,"Ongoing","Sandoz Incorporated","Broomfield","CO","US","Voluntary: Firm Initiated","Letter","Shipped to one distibutor, Putney Inc in Maine. No foreign, military, or government consignees.","V-146-2013","Class II","Amoxicillin Capsules, USP, 500mg, 500 count bottles, NDC 26637-222-50.","Lot CS2959, Expiry 07-2015, NDC 26637-222-50.",,"1458 bottles of 500 capsules each","Sandoz is recalling certain lots of Amoxicillin Capsules, USP 500mg due to potential contamination with fragments of stainless steel wire mesh.",4/22/2013,"04/22/2013",5/8/2013,"05/08/2013"
"Drugs",64957,"Ongoing","Axium Healthcare Pharmacy dba Balanced Solutions Compounding","Lake Mary","FL","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","CO, GA, MI, and Puerto Rico","D-273-2013","Class II","Betamethasone Injectable Balanced Solutions, Compounding Pharmacy a division of Axium Healthcare Pharmacy, Inc., Lake Mary, FL 32746","All Lots",".","401 vials (10 mL vials each)","Lack of Assurance of Sterility:All sterile products compounded, repackaged, and distributed by this compounding pharmacy due to lack of sterility assurance and concerns associated with the quality control processes. ",4/17/2013,"04/17/2013",5/1/2013,"05/01/2013"
"Drugs",64957,"Ongoing","Axium Healthcare Pharmacy dba Balanced Solutions Compounding","Lake Mary","FL","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","CO, GA, MI, and Puerto Rico","D-287-2013","Class II","QuadMix Injectable Balanced Solutions, Compounding Pharmacy a division of Axium Healthcare Pharmacy, Inc., Lake Mary, FL 32746","ALL Lots",".","3 vials (10 mL each)","Lack of Assurance of Sterility:All sterile products compounded, repackaged, and distributed by this compounding pharmacy due to lack of sterility assurance and concerns associated with the quality control processes. ",4/17/2013,"04/17/2013",5/1/2013,"05/01/2013"
"Drugs",64957,"Ongoing","Axium Healthcare Pharmacy dba Balanced Solutions Compounding","Lake Mary","FL","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","CO, GA, MI, and Puerto Rico","D-275-2013","Class II","Cyanocobalamin (CMP) Injectable Balanced Solutions, Compounding Pharmacy a division of Axium Healthcare Pharmacy, Inc., Lake Mary, FL 32746","All Lots",".","15 vials ((30 mL each)","Lack of Assurance of Sterility:All sterile products compounded, repackaged, and distributed by this compounding pharmacy due to lack of sterility assurance and concerns associated with the quality control processes. ",4/17/2013,"04/17/2013",5/1/2013,"05/01/2013"
"Drugs",64957,"Ongoing","Axium Healthcare Pharmacy dba Balanced Solutions Compounding","Lake Mary","FL","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","CO, GA, MI, and Puerto Rico","D-289-2013","Class II","Bacteriostatic Water for Injection 0.9% Injectable Balanced Solutions, Compounding Pharmacy a division of Axium Healthcare Pharmacy, Inc., Lake Mary, FL 32746","ALL Lots",".",,"Lack of Assurance of Sterility:All sterile products compounded, repackaged, and distributed by this compounding pharmacy due to lack of sterility assurance and concerns associated with the quality control processes. ",4/17/2013,"04/17/2013",5/1/2013,"05/01/2013"
"Drugs",64957,"Ongoing","Axium Healthcare Pharmacy dba Balanced Solutions Compounding","Lake Mary","FL","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","CO, GA, MI, and Puerto Rico","D-279-2013","Class II","Phosphatidylcholine Injectable Balanced Solutions, Compounding Pharmacy a division of Axium Healthcare Pharmacy, Inc., Lake Mary, FL 32746","All Lots",".","5 vials (3 mL each)","Lack of Assurance of Sterility:All sterile products compounded, repackaged, and distributed by this compounding pharmacy due to lack of sterility assurance and concerns associated with the quality control processes. ",4/17/2013,"04/17/2013",5/1/2013,"05/01/2013"
"Drugs",64957,"Ongoing","Axium Healthcare Pharmacy dba Balanced Solutions Compounding","Lake Mary","FL","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","CO, GA, MI, and Puerto Rico","D-281-2013","Class II","Mono-mix (Prostaglandin) Injectable Balanced Solutions, Compounding Pharmacy a division of Axium Healthcare Pharmacy, Inc., Lake Mary, FL 32746","ALL Lots",".","15 vials (10 mL each)","Lack of Assurance of Sterility:All sterile products compounded, repackaged, and distributed by this compounding pharmacy due to lack of sterility assurance and concerns associated with the quality control processes. ",4/17/2013,"04/17/2013",5/1/2013,"05/01/2013"
"Drugs",64957,"Ongoing","Axium Healthcare Pharmacy dba Balanced Solutions Compounding","Lake Mary","FL","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","CO, GA, MI, and Puerto Rico","D-290-2013","Class II","Triamcinolone Diacetate Injectable Balanced Solutions, Compounding Pharmacy a division of Axium Healthcare Pharmacy, Inc., Lake Mary, FL 32746","ALL Lots",".","172 vials (5 mL vials each)","Lack of Assurance of Sterility:All sterile products compounded, repackaged, and distributed by this compounding pharmacy due to lack of sterility assurance and concerns associated with the quality control processes. ",4/17/2013,"04/17/2013",5/1/2013,"05/01/2013"
"Drugs",64957,"Ongoing","Axium Healthcare Pharmacy dba Balanced Solutions Compounding","Lake Mary","FL","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","CO, GA, MI, and Puerto Rico","D-283-2013","Class II","BiMix Standard Injectable Balanced Solutions, Compounding Pharmacy a division of Axium Healthcare Pharmacy, Inc., Lake Mary, FL 32746","ALL Lots",".",,"Lack of Assurance of Sterility:All sterile products compounded, repackaged, and distributed by this compounding pharmacy due to lack of sterility assurance and concerns associated with the quality control processes. ",4/17/2013,"04/17/2013",5/1/2013,"05/01/2013"
"Drugs",64957,"Ongoing","Axium Healthcare Pharmacy dba Balanced Solutions Compounding","Lake Mary","FL","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","CO, GA, MI, and Puerto Rico","D-272-2013","Class II","Sodium Tetradecyl Sulfate Injectable Balanced Solutions, Compounding Pharmacy a division of Axium Healthcare Pharmacy, Inc., Lake Mary, FL 32746","All Lots",".","286 vials (30 mL vials each)","Lack of Assurance of Sterility:All sterile products compounded, repackaged, and distributed by this compounding pharmacy due to lack of sterility assurance and concerns associated with the quality control processes. ",4/17/2013,"04/17/2013",5/1/2013,"05/01/2013"
"Drugs",64957,"Ongoing","Axium Healthcare Pharmacy dba Balanced Solutions Compounding","Lake Mary","FL","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","CO, GA, MI, and Puerto Rico","D-293-2013","Class II","Sodium Tetradecyl Sulfate for Injectable Balanced Solutions, Compounding Pharmacy a division of Axium Healthcare Pharmacy, Inc., Lake Mary, FL 32746","ALL Lots",".","5 vials (30 mL each)","Lack of Assurance of Sterility:All sterile products compounded, repackaged, and distributed by this compounding pharmacy due to lack of sterility assurance and concerns associated with the quality control processes. ",4/17/2013,"04/17/2013",5/1/2013,"05/01/2013"
"Drugs",64957,"Ongoing","Axium Healthcare Pharmacy dba Balanced Solutions Compounding","Lake Mary","FL","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","CO, GA, MI, and Puerto Rico","D-288-2013","Class II","DMSO 50% Sterile Bladder Irrigation Solution Injectable Balanced Solutions, Compounding Pharmacy a division of Axium Healthcare Pharmacy, Inc., Lake Mary, FL 32746","ALL Lots",".","2 50 mL vials","Lack of Assurance of Sterility:All sterile products compounded, repackaged, and distributed by this compounding pharmacy due to lack of sterility assurance and concerns associated with the quality control processes. ",4/17/2013,"04/17/2013",5/1/2013,"05/01/2013"
"Drugs",64957,"Ongoing","Axium Healthcare Pharmacy dba Balanced Solutions Compounding","Lake Mary","FL","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","CO, GA, MI, and Puerto Rico","D-270-2013","Class II","TriMix Standartd (PGE Stock Sol'n) Injectable Balanced Solutions, Compounding Pharmacy a division of Axium Healthcare Pharmacy, Inc., Lake Mary, FL 32746","All Lots",".","380 vials (5 mL and 10 mL vials)","Lack of Assurance of Sterility:All sterile products compounded, repackaged, and distributed by this compounding pharmacy due to lack of sterility assurance and concerns associated with the quality control processes. ",4/17/2013,"04/17/2013",5/1/2013,"05/01/2013"
"Drugs",64957,"Ongoing","Axium Healthcare Pharmacy dba Balanced Solutions Compounding","Lake Mary","FL","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","CO, GA, MI, and Puerto Rico","D-286-2013","Class II","17 Alpha Hydroxyprogesterone Caproate Injectable Balanced Solutions, Compounding Pharmacy a division of Axium Healthcare Pharmacy, Inc., Lake Mary, FL 32746","ALL Lots",".","4 vials (5 mL each)","Lack of Assurance of Sterility:All sterile products compounded, repackaged, and distributed by this compounding pharmacy due to lack of sterility assurance and concerns associated with the quality control processes. ",4/17/2013,"04/17/2013",5/1/2013,"05/01/2013"
"Drugs",64957,"Ongoing","Axium Healthcare Pharmacy dba Balanced Solutions Compounding","Lake Mary","FL","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","CO, GA, MI, and Puerto Rico","D-274-2013","Class II","Triamcinolone Hexacetonide Injectable Balanced Solutions, Compounding Pharmacy a division of Axium Healthcare Pharmacy, Inc., Lake Mary, FL 32746","All Lots",".","28 vials (10 mL each)","Lack of Assurance of Sterility:All sterile products compounded, repackaged, and distributed by this compounding pharmacy due to lack of sterility assurance and concerns associated with the quality control processes. ",4/17/2013,"04/17/2013",5/1/2013,"05/01/2013"
"Drugs",64957,"Ongoing","Axium Healthcare Pharmacy dba Balanced Solutions Compounding","Lake Mary","FL","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","CO, GA, MI, and Puerto Rico","D-294-2013","Class II","BiMix Customs Injectable Balanced Solutions, Compounding Pharmacy a division of Axium Healthcare Pharmacy, Inc., Lake Mary, FL 32746","ALL Lots",".","1 vial (10 mL)","Lack of Assurance of Sterility:All sterile products compounded, repackaged, and distributed by this compounding pharmacy due to lack of sterility assurance and concerns associated with the quality control processes. ",4/17/2013,"04/17/2013",5/1/2013,"05/01/2013"
"Drugs",64957,"Ongoing","Axium Healthcare Pharmacy dba Balanced Solutions Compounding","Lake Mary","FL","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","CO, GA, MI, and Puerto Rico","D-285-2013","Class II","Quadmix Custom Injectable Balanced Solutions, Compounding Pharmacy a division of Axium Healthcare Pharmacy, Inc., Lake Mary, FL 32746","ALL Lots",".","3 vials (10 mL vials)","Lack of Assurance of Sterility:All sterile products compounded, repackaged, and distributed by this compounding pharmacy due to lack of sterility assurance and concerns associated with the quality control processes. ",4/17/2013,"04/17/2013",5/1/2013,"05/01/2013"
"Drugs",64957,"Ongoing","Axium Healthcare Pharmacy dba Balanced Solutions Compounding","Lake Mary","FL","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","CO, GA, MI, and Puerto Rico","D-277-2013","Class II","Progesterone in Olive Oil Injectable Balanced Solutions, Compounding Pharmacy a division ofAxium Healthcare Pharmacy, Inc., Lake Mary, FL 32746","All Lots",".","11 vials (10 mL each)","Lack of Sterility Assurance",4/17/2013,"04/17/2013",5/1/2013,"05/01/2013"
"Drugs",64957,"Ongoing","Axium Healthcare Pharmacy dba Balanced Solutions Compounding","Lake Mary","FL","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","CO, GA, MI, and Puerto Rico","D-284-2013","Class II","BiMix Plus Injectable Balanced Solutions, Compounding Pharmacy a division of Axium Healthcare Pharmacy, Inc., Lake Mary, FL 32746","ALL Lots",".","6 vials (5 mL and 10 mL each)","Lack of Assurance of Sterility:All sterile products compounded, repackaged, and distributed by this compounding pharmacy due to lack of sterility assurance and concerns associated with the quality control processes. ",4/17/2013,"04/17/2013",5/1/2013,"05/01/2013"
"Drugs",64957,"Ongoing","Axium Healthcare Pharmacy dba Balanced Solutions Compounding","Lake Mary","FL","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","CO, GA, MI, and Puerto Rico","D-292-2013","Class II","HCG Lyophylized Powder 10,000 unit for Injectable Balanced Solutions, Compounding Pharmacy a division of Axium Healthcare Pharmacy, Inc., Lake Mary, FL 32746","ALL Lots",".","1 vial (10 mL)","Lack of Sterility Assurance",4/17/2013,"04/17/2013",5/1/2013,"05/01/2013"
"Drugs",64957,"Ongoing","Axium Healthcare Pharmacy dba Balanced Solutions Compounding","Lake Mary","FL","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","CO, GA, MI, and Puerto Rico","D-291-2013","Class II","Triamcinolone Acetonide Injectable Balanced Solutions, Compounding Pharmacy a division of Axium Healthcare Pharmacy, Inc., Lake Mary, FL 32746","ALL Lots",".","18 viasl (10 mL each)","Lack of Assurance of Sterility:All sterile products compounded, repackaged, and distributed by this compounding pharmacy due to lack of sterility assurance and concerns associated with the quality control processes. ",4/17/2013,"04/17/2013",5/1/2013,"05/01/2013"
"Drugs",64957,"Ongoing","Axium Healthcare Pharmacy dba Balanced Solutions Compounding","Lake Mary","FL","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","CO, GA, MI, and Puerto Rico","D-271-2013","Class II","Methylprednisolone Acetate injectable Balanced Solutions, Compounding Pharmacy a division of Axium Healthcare Pharmacy, Inc., Lake Mary, FL 32746","All Lots",".","326 vials (10 mL each)","Lack of Assurance of Sterility:All sterile products compounded, repackaged, and distributed by this compounding pharmacy due to lack of sterility assurance and concerns associated with the quality control processes. ",4/17/2013,"04/17/2013",5/1/2013,"05/01/2013"
"Drugs",64957,"Ongoing","Axium Healthcare Pharmacy dba Balanced Solutions Compounding","Lake Mary","FL","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","CO, GA, MI, and Puerto Rico","D-280-2013","Class II","Comprehensive injection #4 - SS varied injectable Injectable Balanced Solutions, Compounding Pharmacy a division of Axium Healthcare Pharmacy, Inc., Lake Mary, FL 32746","All Lots",".","10 vials (30 mL each)","Lack of Assurance of Sterility:All sterile products compounded, repackaged, and distributed by this compounding pharmacy due to lack of sterility assurance and concerns associated with the quality control processes. ",4/17/2013,"04/17/2013",5/1/2013,"05/01/2013"
"Drugs",64957,"Ongoing","Axium Healthcare Pharmacy dba Balanced Solutions Compounding","Lake Mary","FL","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","CO, GA, MI, and Puerto Rico","D-295-2013","Class II","Cyclosporin in Corn Oil Injectable Balanced Solutions, Compounding Pharmacy a division of Axium Healthcare Pharmacy, Inc., Lake Mary, FL 32746","ALL Lots",".","1 vial (15 mL)","Lack of Assurance of Sterility:All sterile products compounded, repackaged, and distributed by this compounding pharmacy due to lack of sterility assurance and concerns associated with the quality control processes. ",4/17/2013,"04/17/2013",5/1/2013,"05/01/2013"
"Drugs",64957,"Ongoing","Axium Healthcare Pharmacy dba Balanced Solutions Compounding","Lake Mary","FL","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","CO, GA, MI, and Puerto Rico","D-276-2013","Class II","Methylcobalamin and Folic Acid Injectable Balanced Solutions, Compounding Pharmacy a division of Axium Healthcare Pharmacy, Inc., Lake Mary, FL 32746","All Lots",".","29 vials (9 mL and 30 mL)","Lack of Assurance of Sterility:All sterile products compounded, repackaged, and distributed by this compounding pharmacy due to lack of sterility assurance and concerns associated with the quality control processes. ",4/17/2013,"04/17/2013",5/1/2013,"05/01/2013"
"Drugs",64957,"Ongoing","Axium Healthcare Pharmacy dba Balanced Solutions Compounding","Lake Mary","FL","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","CO, GA, MI, and Puerto Rico","D-282-2013","Class II","Trimix Customs Injectable Balanced Solutions, Compounding Pharmacy a division of Axium Healthcare Pharmacy, Inc., Lake Mary, FL 32746","ALL Lots",".","61 vials (5 mL and 10 mL vials)","Lack of Assurance of Sterility:All sterile products compounded, repackaged, and distributed by this compounding pharmacy due to lack of sterility assurance and concerns associated with the quality control processes. ",4/17/2013,"04/17/2013",5/1/2013,"05/01/2013"
"Drugs",64957,"Ongoing","Axium Healthcare Pharmacy dba Balanced Solutions Compounding","Lake Mary","FL","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","CO, GA, MI, and Puerto Rico","D-278-2013","Class II","Cyclosporin (Grapeseed Oil) Ophthalmic Balanced Solutions, Compounding Pharmacy a division of Axium Healthcare Pharmacy, Inc., Lake Mary, FL 32746","All Lots",".","12 vials (15 mL each)","Lack of Assurance of Sterility:All sterile products compounded, repackaged, and distributed by this compounding pharmacy due to lack of sterility assurance and concerns associated with the quality control processes. ",4/17/2013,"04/17/2013",5/1/2013,"05/01/2013"
"Food",64958,"Ongoing","Go Max Go Foods","Santa Fe","NM","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Nationwide distribution to 14 distributors and 26 retailers. Products were distributed to Canada, UK, Germany, and Australia. No government or VA consignees.","F-1431-2013","Class I","Cleo's Peanut Butter Cups creamy peanut butter in a rice-milk chocolately coating, 1.5 oz, gluten-free, dairy-free & vegan, no trans fats, nothing artificial. Distributed by Go Max Go Foods, LLC 40 Paseo Del Antiope, Santa Fe, NM 87506.","UPC 899033002040",".","74,364 bars","Go Max Go Foods is recalling various lots of vegan candy bar products containing the statement ''dairy-free'' due to undeclared milk.",4/22/2013,"04/22/2013",5/29/2013,"05/29/2013"
"Food",64958,"Ongoing","Go Max Go Foods","Santa Fe","NM","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Nationwide distribution to 14 distributors and 26 retailers. Products were distributed to Canada, UK, Germany, and Australia. No government or VA consignees.","F-1436-2013","Class I","Mahalo Candy Bar. Coconut & almonds in a a rice-milk chocolately coating, 2.0 oz, gluten-free,dairy-free & vegan, no trans fats, nothing artificial. Distributed by Go Max Go Foods, LLC 40 Paseo Del Antilope, Santa Fe, NM 87506.","UPC 899033002033",".","106,908 bars","Go Max Go Foods is recalling various lots of vegan candy bar products containing the statement ''dairy-free'' due to undeclared milk.",4/22/2013,"04/22/2013",5/29/2013,"05/29/2013"
"Food",64958,"Ongoing","Go Max Go Foods","Santa Fe","NM","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Nationwide distribution to 14 distributors and 26 retailers. Products were distributed to Canada, UK, Germany, and Australia. No government or VA consignees.","F-1435-2013","Class I","Thumbs Up Candy Bar. A Crunchy, Peanut Buttery Center in a a rice-milk chocolately coating, 1.3 oz, gluten-free,dairy-free & vegan, no trans fats, nothing artificial. Distributed by Go Max Go Foods, LLC 40 Paseo Del Antilope, Santa Fe, NM 87506.","UPC 899033002064",".","16,236 bars","Go Max Go Foods is recalling various lots of vegan candy bar products containing the statement ''dairy-free'' due to undeclared milk.",4/22/2013,"04/22/2013",5/29/2013,"05/29/2013"
"Food",64958,"Ongoing","Go Max Go Foods","Santa Fe","NM","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Nationwide distribution to 14 distributors and 26 retailers. Products were distributed to Canada, UK, Germany, and Australia. No government or VA consignees.","F-1432-2013","Class I","Jokerz Candy Bar peanuts, caramel, & nougat in a a rice-milk chocolately coating, 2.1 oz, dairy-free, vegan, no trans fats, nothing artificial. Distributed by Go Max Go Foods, LLC 40 Paseo Del Antilope, Santa Fe, NM 87506.","UPC 899033002002",".","128,604 bars","Go Max Go Foods is recalling various lots of vegan candy bar products containing the statement ''dairy-free'' due to undeclared milk.",4/22/2013,"04/22/2013",5/29/2013,"05/29/2013"
"Food",64958,"Ongoing","Go Max Go Foods","Santa Fe","NM","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Nationwide distribution to 14 distributors and 26 retailers. Products were distributed to Canada, UK, Germany, and Australia. No government or VA consignees.","F-1434-2013","Class I","Buccaneer Candy Bar chocolatey nougat in a a rice-milk chocolately coating, 2.0 oz, dairy-free, vegan, no trans fats, nothing artificial. Distributed by Go Max Go Foods, LLC 40 Paseo Del Antilope, Santa Fe, NM 87506.","UPC 899033002026",".","53,916 bars","Go Max Go Foods is recalling various lots of vegan candy bar products containing the statement ''dairy-free'' due to undeclared milk. ",4/22/2013,"04/22/2013",5/29/2013,"05/29/2013"
"Food",64958,"Ongoing","Go Max Go Foods","Santa Fe","NM","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Nationwide distribution to 14 distributors and 26 retailers. Products were distributed to Canada, UK, Germany, and Australia. No government or VA consignees.","F-1430-2013","Class I","Snap! crisped rice in a rice-milk chocolatey coating, 1.75 oz, dairy-free, vegan, no trans fats, no hydrogenated oils, no cholesterol, nothing artificial. Distributed by Go Max Go Foods, LLC 57 Puye Road, Santa Fe, NM 87505.","UPC 899033002097",".","38,928 bars","Go Max Go Foods is recalling various lots of vegan candy bar products containing the statement ''dairy-free'' due to undeclared milk.",4/22/2013,"04/22/2013",5/29/2013,"05/29/2013"
"Food",64958,"Ongoing","Go Max Go Foods","Santa Fe","NM","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Nationwide distribution to 14 distributors and 26 retailers. Products were distributed to Canada, UK, Germany, and Australia. No government or VA consignees.","F-1433-2013","Class I","Twilight Candy Bar caramel & chocolatey nougat in a a rice-milk chocolately coating, 2.1 oz, dairy-free, vegan, no trans fats, nothing artificial. Distributed by Go Max Go Foods, LLC 40 Paseo Del Antilope, Santa Fe, NM 87506.","UPC 899033002019",".","100,308 bars","Go Max Go Foods is recalling various lots of vegan candy bar products containing the statement ''dairy-free'' due to undeclared milk.",4/22/2013,"04/22/2013",5/29/2013,"05/29/2013"
"Devices",64959,"Ongoing","Bio-rad Laboratories, Inc.","Irvine","CA","US","Voluntary: Firm Initiated","E-Mail","Worldwide Distribution - Distributed in San Juan Puerto Rico and the states of NM, NY, MN, OR and WI., and the countries of Australia, Brazil, France, Italy, Korea, and New Zealand.","Z-1330-2013","Class III","Liquichek'' ToRCH Plus IgM Control - Positive Liquichek ToRCH Plus IgM Control is intended for use as an unassayed quality control serum to monitor precision of IgM laboratory testing procedures for the analytes listed in this package insert. This product is not intended for use in blood donor screening assays. Analytes claimed with this lot of Liquichek ToRCH Plus IgM Control: Cytomegalovirus (CMV) IgM Herpes Simplex Virus Type 1/2 (HSV-1/2) IgM Rubella Virus IgM Toxoplasma gondii IgM ","Lot Number 18972, Catalog Number 229 and 229PX.",,"211 boxes and 5 MiniPaks","The Liquichek'' ToRCH Plus IgM Control - Positive, contains detectable levels of HCV RNA which originated from the non-specific human IgM component used in the mouse monoclonal antibody conjugation process for this product.",4/15/2013,"04/15/2013",5/22/2013,"05/22/2013"
"Drugs",64960,"Ongoing","Qualitest Pharmaceuticals","Huntsville","AL","US","Voluntary: Firm Initiated","Letter","Nationwide","D-298-2013","Class II","GLIMEPIRIDE TABLETS USP, 2 mg, 100-count tablets per bottle, Rx only, Manufactured for: Qualitest Pharmaceuticals, Huntsville, AL 35811, NDC 0603-3745-21.","Lot #: C0671212A, Exp 12/14",".","10,373 bottles","Failed Tablet/Capsule Specifications: One oversized tablet was found in a sealed 100 count bottle of Glimepiride at the retail level.",4/19/2013,"04/19/2013",5/1/2013,"05/01/2013"
"Devices",64962,"Ongoing","Symmetry Medical/SSI","Antioch","TN","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution - USA including CA, MS, FL, PA, TN, CO, IL, TX, OH, MI, MA, IL and internationally to Belgium, Canada, Germany, UK","Z-1267-2013","Class II","Codman(R) Collins Radioparent Sternal Blade Nylon,4 3/4'' (121 mm) long, 3'' (76 mm) wide, 1 1/2'' (38 mm) deep, REF 50-8081 sternum retractor","244576, 244582, 244584, 268916, 268920, 276513, 276514, 296136, 296139, 296141, 296153, 296155, 296156, 296157, 296160",".","524 boxes of 10","There is a possibility that the Collins Radioparent Sternal Blades Nylon may break during use.",4/10/2013,"04/10/2013",5/15/2013,"05/15/2013"
"Drugs",64963,"Ongoing","Tarmac Products, Inc. d.b.a. Axara Pharmaceuticals","Miami Gardens","FL","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Nationwide","D-311-2013","Class II","''Well at Wallgreens'' Regular Strength Antacid Liquid (Alumina/Magnesia/Simethicone/Antacid & Anti Gas); Mint, a)12 oz bottle (NDC 0363-0073-02), b) 26 oz. bottle (NDC 0363-0073-26), Distributed by Walgreens CO., 200 Wilmot Rd, Deerfield, IL 60015.","Lot Number #:13B0023; exp 02/15 FP-4809 (12oz) FP-4810 (26oz)",,"13,369 bottles (12oz), 2607 bottles (26oz)","Microbial Contamination of Non-Sterile Products: Lot in question had an elevated microbial count outside of specifications and E. Coli contamination.",3/16/2013,"03/16/2013",5/8/2013,"05/08/2013"
"Biologics",64964,"Terminated","University of Miami Miller School of Medicine Tissue Bank","Miami","FL","US","Voluntary: Firm Initiated","E-Mail","California","B-0001-14","Class II","Bone","103940051; 103940052; 103940053; 103940054; 103940055; 103940056; 103940057; 103940058; 103940059; 103940060; 103940061; 103940062; 103940063; 103940064; 103940065; 103940066; 103940067; 103940068; 103940069; 103940070; 103940071; 103940072; 103940073; 103940074; 103940075; 103940076; 103940077; 103940078; 103940079; 103940080; 103940081; 103940082; 103940083; 103940084; 103940085; 103940086; 103940087; 103940088; 103940089; 103940090; 103940091; 103940092; 103940093; 103940094; 103940095; 103940096; 103940097; 103940098; 103940099; 103940100; 103940101; 103940102; 103940103; 103940104; 103940105; 103940106; 103940107; 103940108; 103940109; 103940110; 103940111; 103940112; 103940113; 103940114; 103940115; 103940116; 103940117; 103940118; 103940119; 103940120; 103940121; 103940122; 103940123; 103940124; 103940125; 103940126; 103940127; 103940128; 103940129; 103940233; 103940234; 103940235; 103940236; 103940238; 103940239; 103940240; 103940241; 103940247; 103940258; 103940259; 103940260; 103940261; 103940262; 103940263; 103940264; 103940265; 103940266; 103940267; 103940268; 103940271; 103940272; 103940273; 103940274; 103940275; 103940276; 103940277; 103940278; 103940279; 103940280; 103940281; 103940282; 103940283; 103940284; 103940285; 103940286; 103940287; 103940288; 103940289; 103940290; 103940291; 103940292; 103940293; 103940294; 103940295; 103940296; 103940297; 103940298; 103940299; 103940300; 103940301; 103940302; 103940303; 103940304; 103940305; 103940306; 103940307; 103940308; 103940309; 103940310; 103940311; 103940312; 103940313; 103940314; 103940315; 103940316; 103940317; 103940318; 103940319; 103940320 ",,"149 tissue allografts","Human tissue allografts, not processed in a manner that prevents the introduction, transmission, or spread of communicable disease, were distributed.",2/19/2013,"02/19/2013",12/18/2013,"12/18/2013"
"Devices",64965,"Ongoing","Xlumena, Inc.","Mountain View","CA","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution - USA including AZ, CA, FL, GA, IN, NY,SC, WA, PA, IL, CO, and internationally to Netherlands, Germany, Spain, Denmark, and Switzerland.","Z-2167-2013","Class II","Xlumena brand NAVIX Access Device, Model/Catalogue Number: NVX-10-03, Part Number: FG-00666, Product is manufactured and distributed by Xlumena, Inc., Mountain View, CA The NAVIX Access Device is a multi-lumen balloon catheter with a trocar, anchor balloon, and dilation balloon that creates and dilates a tract across tissue planes. The NAVIX Access Device is indicated for use as an accessory to cannulate the transgastric or transduodenal wall and into a pancreatic pseudocyst, when it is visibly bulging into the gastrointestinal tract during endoscopic procedures. ","All lots are involved are being recalled, including FGS00048, FGS0005, FGS00058, FGS00059, FGS00069, FGS00073, FGS00081, FGS00086, FGS00091",".","148 units","A complaint investigation has found that product fractures can occur at the distal end of the catheter under load. ",4/17/2013,"04/17/2013",9/18/2013,"09/18/2013"
"Food",64967,"Ongoing","Alfred Louie Inc","Bakersfield","CA","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","CA, ID, AZ, NV.","F-1444-2013","Class I","Bean Sprouts: Keep Refrigerated: Ingredients: Mung Beans Net WT: 10 lbs (4.54 KG); Alfred Louis Inc., Bakersfield, CA 93309 Product of the USA. UPC 00000 20001","no codes on products",".",,"FDA environmental samples found Listeria Monocytogenes on product in packing line and on food contact surfaces in the facility.",4/22/2013,"04/22/2013",5/29/2013,"05/29/2013"
"Food",64967,"Ongoing","Alfred Louie Inc","Bakersfield","CA","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","CA, ID, AZ, NV.","F-1445-2013","Class II","Soy Bean Sprouts: Keep Refrigerated: Ingredients:Soy Beans Net WT: 5 lbs (2.27 KG); Alfred Louis Inc., Bakersfield, CA 93309 Product of the USA. ","no codes on products",".","xx","FDA environmental samples found Listeria Monocytogenes on product in packing line and on food contact surfaces in the facility.",4/22/2013,"04/22/2013",5/29/2013,"05/29/2013"
"Devices",64968,"Ongoing","Leica Microsystems, Inc.","Buffalo Grove","IL","US","Voluntary: Firm Initiated","Letter","Worldwide distribution: US (nationwide) to states of AZ and KY; and the country of New Zealand.","Z-1446-2013","Class II","LPC Fine Mesh Cassette for the Leica LPC Printer. Part No: 14060546848; 14060546846; 14060546845; 14060546933; 14060546932; 14060546852; 14060546850; 14060546847. The intended use of this device is for storage of specimens/tissues during processing.","1) Part No.: 14060546848; Batch No.s: 8280-10309, 82801-0310; 2) Part No.: 14060546846; Batch No.s: 1034710114; 3) Part No.: 14060546845; Batch No.s: 1021420914; 4) Part No.: 14060546933; Batch No.s: 82801-0217; 5) Part No.: 14060546932; Batch No.s: 1030730112, 1101110204; 6) Part No.: 14060546852; Batch No.s: 1101910322; 7) Part No.: 14060546850; Batch No.s: 1034710204, 1034710328, 1113910803; 8) Part No.: 14060546847; Batch No.s: 913920827 ",".","20,160 units","An LPC Fine Mesh Cassette failed to stay closed during processing operations. ",4/4/2013,"04/04/2013",6/12/2013,"06/12/2013"
"Devices",64970,"Ongoing","SpineFrontier, Inc.","Beverly","MA","US","Voluntary: Firm Initiated","E-Mail","Worldwide Distribution-USA including the states of FL, OH, MA, and TX, and the countries of Mexico, and Dominican Republic.","Z-1958-2013","Class II","Case Lid and Base (Inspan, Invue, SLIFT) Caddy Lid (Inspan, Arena-C); Inspan Lid: 12-60039A, 11-60042B, 11-60043B, 11-60045B, 11-60046C, 11-60045A, 11-60046A, 11-60053A; Invue Lid: SI70095A; S-Lift Lid: SI50070A; S-Lift Base: SI50067A; Arena-C Lid: 11-72013D, 11-72014D; Generics Lid: 12-99005A. System cases are designed to hold and secure all instrumentation to be used with a surgical system. ","Inspan Lid: Part Number: 12-60039A, 11-60042B, 11-60043B, 11-60045B, 11-60046C, 11-60045A, 11-60046A, 11-60053A, Lot Numbers: 7197.024, 011649, 011498; Invue Lid: SI70095A, Lot Number: 6250.009-R; S-Lift Lid: SI50070A, Lot Number: 7201.008; S-Lift Base: SI50067A; Lot Numbers: 7183.007R, 7201.007; Arena-C Lid: 11-72013D, 11-72014D, Lot Numbers: 011969-001, 011969-002; Generics Lid: 12-99005A, Lot Number: 8372.001. ",,"258 units (30 in distribution at the time of the recall)","Non-toxic inks, used on the silk screen graphics of the case bases and lids, and caddy lids, were found to be either delaminating or running off from the substrate after repeated washing and sterilization cycles. ",4/22/2013,"04/22/2013",8/21/2013,"08/21/2013"
"Devices",64971,"Ongoing","Carefusion 2200 Inc","Waukegan","IL","US","Voluntary: Firm Initiated","Letter","US Nationwide in the states of AZ, CA, CO, DE, FL, GA, IL, LA, MA, MD, MI, MN, MO, MS, NC, NJ, NM, NY, OH, PA, TX, UT, WA","Z-1947-2013","Class II","1) Adult Manual Resuscitator, 2K8004, Oxygen Reservoir Bag, Adult Mask; 2) Adult Manual Resuscitator, 2K8005, 40'' (1.0 m) Oxygen Reservoir Tubing, Adult Mask; 3) Adult Manual Resuscitator, 2K8017, Variable Volume Oxygen Reservoir Tubing, Adult Mask; 4) Adult Manual Resuscitator, 2K8034, 40'' (1.0 m) Oxygen Reservoir Tubing, PEEP Valve, without Mask; 5) Adult Manual Resuscitator, 2K8035, Oxygen Reservoir Bag, PEEP Valve, Adult Mask; 6) Pediatric Manual Resuscitator, 2K8037, 40'' (1.0 m) Oxygen Reservoir Tubing, PEEP Valve, Pediatric Mask, Pressure Limiting Valve with Lock; 7) Infant Manual Resuscitator, 2K8040, Oxygen Reservoir Bag, PEEP Valve, Infant Mask, Pressure Limiting Valve with Lock Product Usage: Pulmonary resuscitation","1) Product Code 2K8005; Lot Numbers: 0000355656, 0000355659, 0000355662, 0000355664, 0000355665, 0000355666, 0000355668; 2) Product Code 2K8004; Lot Number: 0000355673; 3) Product Code 2K8017; Lot Numbers: 0000355676, 0000355677; 4) Product Code 2K8034; Lot Number: 0000355688; 5) Product Code 2K8035; Lot Number: 0000358023; 6) Product Code 2K8037; Lot Number: 0000358025; 7) Product Code 2K8040; Lot Number: 0000358026",,"14,112 units","CareFusion has received four (4) customer reports of a component (oxygen connector) within the resuscitation bag being occluded which disables the flow of supplemental oxygen to the resuscitation bag and thus may pose a serious patient safety risk.",4/22/2013,"04/22/2013",8/21/2013,"08/21/2013"
"Devices",64972,"Ongoing","Advanced Sterilization Products","Irvine","CA","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution - Nationwide Distribution including the states of AR, AL, AK, AZ, CA, CT, CO, DE, FL, GA, HI, IA, IL, IN, ID, KY, LA, MA, ME, MD, MI, MS, MN, MO, MT, NC, ND, NE, NJ, NY, NV, NH, NM, OH, OR, OK, PA, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI and WV., and the countries of AR, AU, BE, BR, CA, CL, CN, CO, DO, EC, GT, HK, ID, IN, JP, KR, MV, MX, PA, PE, PH, PR, RU, SG, TH, TW, UY, VE and VN.","Z-1180-2013","Class II","STERRAD CYCLESURE 24 Biological Indicator (BI) The STERRAD CYCLESURE 24 Biological Indicator (BI), is intended to be used as a standard method for frequent monitoring of the STERRAD Sterilization System cycles.","Lot Codes: 025127 026127 027127 028127 030127 031127 032127 033127 034127 035127 036127 037127 038121 038127 039127 040127 041121 042127 043127 044127 045121 046127 047127 048127 049127 052127 053121 053127 054127 055121 056127 057127 058127 059127 060127 061127 062121 062127 063127 064127 065127 067127 068127 069121 070127 071127 072127 073127 076121 081127 082127 084127 085127 086121 086127 087127 089127 090127 091127 092127 093121 094127 095127 100121 100127 101127 102127 104127 107121 107127 107128 109127 109128 110127 111127 114121 118127 121121 121127 122127 123127 124127 125127 128121 128127 129127 130127 131127 132127 135121 135127 136127 137127 156121 156127 158127 159127 160127 163121 163127 164127 165127 13912706 18112706 18412706 18512706 18712706 18812706 19012706 19212706 19312706 19412706 19512706 19712706 19812106 19912706 20012106 20112706 20212706 20512106 20512706 20612106 20612706 20712706 20812106 20812706 21212106 21212706 21312106 21312706 21412706 21512106 21512806 21612106 21812706 21912706 22012106 22112706 22212706 22312706 22612106 22612706 22712706 22812106 22812706 22912706 23012106 23012706 23112706 23312106 23312706 23412706 23512106 23512706 23612706 23712106 23712706 23812706 24012106 24012706 24112706 24212106 24212706 24312706 24412706 24812106 24812706 24912106 24912706 25012706 25112706 25412106 25412706 25512106 25512706 25612106 25812106 25812706 25912706 26112106 26212706 26312106 26312706 26812106 26812706 30112706 ",,"69,994 cases","Advanced Sterilization Products is recalling certain lots of STERRAD CYCLESURE 24 Biological Indicator product because it may not have adequate data to support the entire duration of the labeled shelf-life.",4/22/2013,"04/22/2013",5/8/2013,"05/08/2013"
"Devices",64973,"Ongoing","The Anspach Effort, Inc.","Palm Beach Gardens","FL","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Worldwide Distribution - USA Nationwide including the states of: AZ, CA, FL, KY, ME, MI, MO, OH, PA, TN, TX , VA, and the countries of: Australia, Egypt, Italy, Japan, Switzerland, Taiwan, and Turkey;","Z-1659-2013","Class II","***REF SC2102***eMax 2 Plus Console, Single Port, no Irrigation***SN G16307882402*** Product Usage: The eMax console is intended to operate the eMax system which is used for cutting and shaping bone including spine and cranium. The RPM of the Motor Handpiece may be less than 80,000 RPM (approximately 72,000 RPM) in the free running state when using the optional Hand Control. The low Motor Handpiece RPM would only be experienced in the Free running state (Hand Control fully depressed and no load on the cutting bur). This condition would not affect the power output of the Handpiece in the loaded working range (typically 50,000 to 70,000 RPM). ","SC2100 System Console Emax 2 Plus; SC2101 System Console, Single Port with irrigation; SC2102 System Console, Single Port, without Irrigation; ",".","61 units","The RPM of the Motor Handpiece may be less than 80,000 RPM. ",6/24/2011,"06/24/2011",7/10/2013,"07/10/2013"
"Devices",64973,"Ongoing","The Anspach Effort, Inc.","Palm Beach Gardens","FL","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Worldwide Distribution - USA Nationwide including the states of: AZ, CA, FL, KY, ME, MI, MO, OH, PA, TN, TX , VA, and the countries of: Australia, Egypt, Italy, Japan, Switzerland, Taiwan, and Turkey;","Z-1657-2013","Class II","***REF SC2100***eMax 2 Plus Console***SN G 10307653002*** Product Usage: The RPM of the Motor Handpiece may be less than 80,000 RPM (approximately 72,000 RPM) in the free running state when using the optional Hand Control. The low Motor Handpiece RPM would only be experienced in the Free running state (Hand Control fully depressed and no load on the cutting bur). This condition would not affect the power output of the Handpiece in the loaded working range (typically 50,000 to 70,000 RPM. ","SC2100 System Console Emax 2 Plus; SC2101 System Console, Single Port with irrigation; SC2102 System Console, Single Port, without Irrigation. ",".","61 units","The RPM of the Motor Handpiece may be less than 80,000 RPM. ",6/24/2011,"06/24/2011",7/10/2013,"07/10/2013"
"Devices",64973,"Ongoing","The Anspach Effort, Inc.","Palm Beach Gardens","FL","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Worldwide Distribution - USA Nationwide including the states of: AZ, CA, FL, KY, ME, MI, MO, OH, PA, TN, TX , VA, and the countries of: Australia, Egypt, Italy, Japan, Switzerland, Taiwan, and Turkey;","Z-1658-2013","Class II","***REF SC2101***eMax 2 Plus Console, Single Port, with Irrigation***SN G17307901802*** Product Usage: The RPM of the Motor Handpiece may be less than 80,000 RPM (approximately 72,000 RPM) in the free running state when using the optional Hand Control. The low Motor Handpiece RPM would only be experienced in the Free running state (Hand Control fully depressed and no load on the cutting bur). This condition would not affect the power output of the Handpiece in the loaded working range (typically 50,000 to 70,000 RPM. ","SC2100 System Console Emax 2 Plus; SC2101 System Console, Single Port with irrigation; SC2102 System Console, Single Port, without Irrigation; ",".","61 units","The RPM of the Motor Handpiece may be less than 80,000 RPM. ",6/24/2011,"06/24/2011",7/10/2013,"07/10/2013"
"Drugs",64974,"Ongoing","Legacy Pharmaceutical Packaging LLC","Earth City","MO","US","Voluntary: Firm Initiated","Telephone","Nationwide","D-319-2013","Class II","Walmart Amlodipine Besylate Tablets, USP 10 mg, Rx only, 30 tablets, Manufactured by: InvaGen Pharmaceuticals, Inc., Hauppauge, NY. Manufactured for: Camber Pharmaceuticals, Inc., Piscataway, NJ. Distributed by: Wal-Mart Stores, Inc., Bentonville, AR. Packaged by: Legacy Pharmaceutical Packaging, LLC, Earth City, MO. NDC 68645-445-70.","Lot # 130251, 130252, 130253 Exp date: 11/14",,"484,236 cartons","Labeling: Labeling Error on Declared Strength; product label incorrectly states Amlodipine 5 mg instead of Amlodipine 10 mg. Tablet strength is 10 mg",4/22/2013,"04/22/2013",5/22/2013,"05/22/2013"
"Devices",64975,"Ongoing","Cook, Inc.","Bloomington","IN","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution - USA Nationwide; in the countries of Japan, Europe, Brazil, and Australia","Z-1275-2013","Class I","Zilver PTX Drug-Eluting Peripheral Stent, - 7 mm X 80mm; 125 cm, Rx, Sterile Product Usage: The Zilver PTX Drug -Eluting Peripheral Stent is a self expanding, small metal, mesh tube (stent) with the outer surface coated with the drug Paclitaxel that can be Implanted in an artery in the thigh (femoropopliteal artery). The Paclitaxel coating helps prevent the artery from narrowing again (restenosis). The Zilver; PTX stent acts as a scaffold to: Hold open a narrowed artery in the thigh (femoropopliteal artery) caused by PAD. Improve blood flow to the extremity. ","REF ZIV6-35-125-7-80-PTX ; UDI 10827002248950 all lots distributed through 4/16/13",,"535 units in USA","Cook Medical has received a small number of complaints related to the delivery system for the Zilver PTX Drug-Eluting Peripheral Stent involving fractures of the delivery system inner catheter after stent deployment, and separation of the inner catheter tip section (13 complaints with an occurrence rate of 0.043%) Two adverse events, including one death, occurred in cases where a tip separation was reported.",4/18/2013,"04/18/2013",5/22/2013,"05/22/2013"
"Devices",64975,"Ongoing","Cook, Inc.","Bloomington","IN","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution - USA Nationwide; in the countries of Japan, Europe, Brazil, and Australia","Z-1274-2013","Class I","Zilver PTX Drug-Eluting Peripheral Stent - 6 mm X 80mm; 125 cm, Rx, Sterile Product Usage: The Zilver PTX Drug -Eluting Peripheral Stent is a self expanding, small metal, mesh tube (stent) with the outer surface coated with the drug Paclitaxel that can be Implanted in an artery in the thigh (femoropopliteal artery). The Paclitaxel coating helps Preven the artery from narrowing again (restenosis). The Zilver; PTX stent acts as a scaffold to: Hold open a narrowed artery in the thigh (femoropopliteal artery) caused by PAD . improve blood flow to the extremity. ","REF ZIV6-35-125-6-80-PTX ; REFG24890 UDI 10827002248905 All lots distributed prior to 4/16/2013",,"1,057 units in USA","Cook Medical has received a small number of complaints related to the delivery system for the Zilver PTX Drug-Eluting Peripheral Stent involving fractures of the delivery system inner catheter after stent deployment, and separation of the inner catheter tip section (13 complaints with an occurrence rate of 0.043%) Two adverse events, including one death, occurred in cases where a tip separation was reported.",4/18/2013,"04/18/2013",5/22/2013,"05/22/2013"
"Biologics",64976,"Terminated","Blood Centers of the Pacific - Irwin Center","San Francisco","CA","US","Voluntary: Firm Initiated","Telephone","California","B-1756-13","Class III","Red Blood Cells Deglycerolized Leukocytes Reduced","W117010183953S, W1170081297363, W117008114557A",".","3 units","Blood products, which did not meet the minimum requirement for Red Blood Cell recovery, were distributed.",3/13/2013,"03/13/2013",7/24/2013,"07/24/2013"
"Biologics",64977,"Terminated","Blood Systems Inc ","Scottsdale","AZ","US","Voluntary: Firm Initiated","FAX","Arizona","B-1755-13","Class II","Red Blood Cells (Apheresis) Leukocytes Reduced","W0410130318458 (2 units)",".","2 units","Blood products, collected from a donor for whom donor suitability was not adequately determined, were distributed.",3/4/2013,"03/04/2013",7/24/2013,"07/24/2013"
"Biologics",64978,"Terminated","Blood Centers of the Pacific - Irwin Center","San Francisco","CA","US","Voluntary: Firm Initiated","Telephone","California","B-1754-13","Class II","Red Blood Cells (Apheresis) Leukocytes Reduced","W117013227836E (2 units)",".","2 units","Blood products, for which the quality control testing was not performed, were distributed.",3/20/2013,"03/20/2013",7/24/2013,"07/24/2013"
"Biologics",64979,"Completed","Community Blood Centers of South Florida, Inc.","Hialeah","FL","US","Voluntary: Firm Initiated","Letter","Michigan, Florida","B-1864-13","Class II","Fresh Frozen Plasma","W036811053144",,"1 unit","Blood products, collected from a donor who lived in an area considered endemic for malaria and had a piercing within 12 months of donation, were distributed.",3/29/2013,"03/29/2013",8/7/2013,"08/07/2013"
"Biologics",64979,"Completed","Community Blood Centers of South Florida, Inc.","Hialeah","FL","US","Voluntary: Firm Initiated","Letter","Michigan, Florida","B-1862-13","Class II","Platelets Pooled Leukocytes Reduced","W036810828093",,"1 unit","Blood products, collected from a donor who lived in an area considered endemic for malaria and had a piercing within 12 months of donation, were distributed.",3/29/2013,"03/29/2013",8/7/2013,"08/07/2013"
"Biologics",64979,"Completed","Community Blood Centers of South Florida, Inc.","Hialeah","FL","US","Voluntary: Firm Initiated","Letter","Michigan, Florida","B-1863-13","Class II","Red Blood Cells Leukocytes Reduced","W036811053144",,"1 unit","Blood products, collected from a donor who lived in an area considered endemic for malaria and had a piercing within 12 months of donation, were distributed.",3/29/2013,"03/29/2013",8/7/2013,"08/07/2013"
"Devices",64984,"Ongoing","SpineFrontier, Inc.","Beverly","MA","US","Voluntary: Firm Initiated","E-Mail","Distribution only in Texas.","Z-1926-2013","Class II","Rev E PedFuse Return Screw Inserter, Part Number: 11-80030 Screw inserters are instruments which capture, hold and drive pedicle screw assemblies. There is a capturing feature that engages and holds the screw in place. There is also a feature used to lock the screw to the inserter before insertion of the screw. They can also be used to remove screws or back screws out. Screw inserters are used during the implantation of spinal pedicle screws intended to provide immobilization and stabilization of spinal segments in skeletally mature patients. Used in conjunction with Pedicle Screw Spinal system marketed as KRD1 PedFuse Pedicle Screw System .","Lot Number: PM3979",".","8","Inserters have a set screw that fixes a collar to the inserter. The screw set can loosen and fall out of the inserter which allows the collar to slide off the proximal end of the inserter. When the collar is not in place the locking sleeve can also slide off the inserter. ",3/14/2013,"03/14/2013",8/14/2013,"08/14/2013"
"Devices",64985,"Ongoing","SpineFrontier, Inc.","Beverly","MA","US","Voluntary: Firm Initiated","E-Mail","US Distribution including Puerto Rico and the states of CO, KS, MA and TX.","Z-1871-2013","Class II","Drill Guide - Chameleon FacetFuse Fixation System, Model: 11-00028 Rev. A FacetFuse Drill Guides were designed to provide a concentric pathway for the drills and taps to access the bone while protecting the soft tissue from the cutting geometry of the drills/taps. In addition the drill guide is used as a reference to measure depth that the drills and taps are protruding into bone, which is measured by depth markings at the proximal end of the drills/taps relative to the proximal end of the drill guide. These devices were used during implantation of spinal intervertebral body fusion devices intended for intervertebral body fusion of the spine of skeletally mature patients.","2520301, 2520307",".","13 drill guides","Prior to use in surgery, the Drill Guides were presenting noticeable degrees of denting and/or bending. As a result, drills and taps could not be directed down guides during surgery due to mechanical interference. ",11/9/2012,"11/09/2012",8/14/2013,"08/14/2013"
"Devices",64986,"Ongoing","Varian Medical Systems, Inc.","Charlottesville","VA","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution in the countries of: Belgium, France, Martinique, Slovenia, Sweden, and the United Kingdom.","Z-1324-2013","Class II","Segmented Cylinder Applicator Set, Model # GM11004150, when used for Pulsed Dose Rate (PDR) Product Usage: Usage: Used during pulsed dose rate brachytherapy to treat vaginal and rectal cancer. ","Serial numbers H640383, H640277, H640384, H640788, H640D126, H640385, H640372, H640303, H640387",,"21 devices","Segmented cylinder applicator set may slip during treatment, causing the delivery of radiation to areas outside the target.",4/11/2013,"04/11/2013",5/22/2013,"05/22/2013"
"Devices",64987,"Ongoing","SpineFrontier, Inc.","Beverly","MA","US","Voluntary: Firm Initiated","E-Mail","US distribution in states of: CO, DC, MA and TX.","Z-1869-2013","Class II","Caddy - PedFuse, Screw Caddy, 8MM and 9MM, Part Number: 11-80009 Rev. B The caddy holds, in an organized fashion within the case, 8mm and 9mm pedicle screws used during implantation of pedicle screw system devices intended to provide immobilization and stabilization of spinal segments of skeletally mature patients","31176, 018652, 018645R, 42011",,"11 caddies","Two sections that are designated for the 8mm and 9mm screws were switched; the holes that hold the 8mm screws are designed for 9mm screws, and the holes that hold the 9mm screws are designated for 8mm screws. ",10/5/2012,"10/05/2012",8/7/2013,"08/07/2013"
"Devices",64988,"Ongoing","Medshape Solutions, INC.","Atlanta","GA","US","Voluntary: Firm Initiated","Letter","Nationwide Distribution including the states of CO, FL, GA, IA, MD, MO, OR, TX, VT, VA, and WI.","Z-1276-2013","Class II","ExoShape Soft Tissue Fastener 12 mm x 30 mm REF 1101-00-1230. For use in the fixation of ligaments, tendons or soft tissue grafts to bone.","Lot No. 113011-002",".","26","Expiration date on the patient label and date on the product carton were not the same.",4/4/2013,"04/04/2013",5/15/2013,"05/15/2013"
"Devices",64989,"Completed","SpineFrontier, Inc.","Beverly","MA","US","Voluntary: Firm Initiated","Telephone","USA Nationwide Distribution including the state of TX","Z-1737-2013","Class II","KRD1 PedFuse Rods, Model: IM80100-13 Rev B Product Usage: Pedicle rods are cylindrical rods which act as a linking mechanism between pedicle screws. The rod sits with the pedicle screw tulip and they are locked into place with a set screw or locking cap. The rod may be placed along several pedicle screws. Component rods are used during implantation of pedicle screw system devices intended to provide immobilization and stabilization of spinal segments of skeletally mature patients.","Lot Number: 002876-007R",".","2 rods","One of the rods in each of two test constructs did not meet fatigue requirement as outlined in ASTM F1717-04 dynamic compression testing 5 million cycles. ",12/30/2011,"12/30/2011",7/24/2013,"07/24/2013"
"Drugs",64990,"Ongoing","Hospira Inc.","Lake Forest","IL","US","Voluntary: Firm Initiated","Letter","Nationwide and Puerto Rico","D-297-2013","Class II","Propofol Injectable Emulsion, 1%, 200 mg/20 mL (10 mg/mL), 20 mL Single patient infusion vial, Rx only, Hospira, Inc., Lake Forest, IL 60045, NDC 0409-4699-30.","Lot #: 11-185-DJ*, 11-196-DJ*, Exp 1NOV2013; * may be followed by 01 or 02",".","245,250 vials","Presence of Particulate Matter: A single visible particulate was identified during a retain sample inspection.",4/8/2013,"04/08/2013",5/1/2013,"05/01/2013"
"Devices",64991,"Completed","SpineFrontier, Inc.","Beverly","MA","US","Voluntary: Firm Initiated","Other","Worldwide distribution: US (nationwide) to states of: CO, MA, and TX; and country of: Jamaica.","Z-1482-2013","Class II","Straight Impactor - Dorado IBC, Part Number: SI02140. The device is used to position implants after they have been inserted into the disc space during implantation of intervertebral body fusion devices.","Lot number: 20856",".","10","During two separate occasions an impactor plate on the handle broke off while being struck by a mallet. ",5/10/2008,"05/10/2008",6/12/2013,"06/12/2013"
"Devices",64992,"Completed","GE Healthcare, LLC","Waukesha","WI","US","Voluntary: Firm Initiated","Visit","Worldwide distribution: USA (nationwide) including states of: AL, AK, AZ, AR, CA, CO, CT, DC, FL, GA, GUAM, IL, IN, IA, KY, LA, ME, MD, MA, MI, MN, MS, MO, NV, NH, NH, NM, NY, NC, ND, OH, OK, OR, PA, SC, SD, TN, TX, UT, VT, VA, WA, WV, WI, and WY; and countries of: Albania, Australia, Bahrain, Belgium, Canada, Chile, Czech Republic, Dominican Republic, France, Germany, Great Britain, Honduras, Hungary, Ireland, Israel, Italy, Japan, Korea, Kuwait, Netherlands, Nigeria, Norway, Romania, Saudi Arabia, Spain, United Arab Emirates and Venezuela.","Z-1942-2013","Class II","GE Healthcare, Optima XR220amx, Optima XR200amx, and Brivo XR285amx. The series are indicated for use on adult and pediatric patients for general-purpose diagnostic radiographic examinations and procedures. The systems are indicated for taking radiographic exposures of the skull, spinal column, chest, abdomen, extremities, and other body pants with the patient sitting, standing, or lying in the prone or supine position. These devices are not intended for mammographic applications.","Serial # 1028082 00000102856WK4 00001027044WK5 00001027046WK0 00001027160WK9 00001027162WK5 00001027164WK1 00001027174WK0 00001027446WK2 00001027449WK6 00001027526WK1 00001027570WK9 00001027739WK0 00001027881WK0 00001027897WK6 00001027900WK8 00001027901WK6 00001027902WK4 00001027903WK2 00001027904WK0 00001027942WK0 00001028045WK1 00001028046WK9 00001028047WK7 00001028048WK5 00001028063WK4 00001028082WK4 00001028219WK2 00001028300WK0 00001028301WK8 00001028304WK2 00001028454WK5 00001028460WK2 00001028461WK0 00001028564WK1 00001028590WK6 00001028591WK4 00001028592WK2 00001028593WK0 00001028594WK8 00001028616WK9 00001028648WK2 00001028649WK0 00001028650WK8 00001028651WK6 00001028653WK2 00001028655WK7 00001028656WK5 00001028657WK3 00001028861WK1 00001028867WK8 00001028931WK2 00001028102WK0 00000102866WK4 00001028918WK9 00001027502WK2 00001027935WK4 00001028206WK9 00001028079WK0 00001028230WK9 00001028277WK0 00001028913WK0 00001027984WK2 00001027349WK8 00001027217WK7 00001027292WK0 00001028037WK8 00001027352WK2 00001027382WK9 00001027345WK6 00001027879WK4 00001028044WK4 00001028075WK8 00001027768WK9 00001027152WK6 00001028025WK3 00001027820WK8 00001027262WK3 00001027774WK7 00001028080WK8 00001028078WK2 00001027501WK4 00001027505WK5 00001028294WK5 00001027361WK3 00001028041WK0 00001028065WK9 00001027322WK5 00001027387WK8 00001027362WK1 00001027344WK9 00001027359WK7 00001028401WK6 00001028491WK7 00001027371WK2 00001028279WK6 00001028276WK2 00001028231WK7 00001028267WK1 00001028076WK6 00001027824WK0 00001027450WK4 00001027992WK5 00001027895WK0 00001027775WK4 00001027421WK5 00001027894WK3 00001027503WK0 00001027693WK9 00001028235WK8 00001028040WK2 00001028039WK4 00001028337WK2 00001027169WK0 00001027207WK8 00001027376WK1 00001027214WK4 00001027356WK3 00001027383WK7 00001027490WK0 00001027773WK9 00001027369WK6 00001027380WK3 00001027583WK2 00001028292WK9 00001028341WK4 00001028291WK1 00001028213WK5 00001027317WK5 00001028284WK6 00001028278WK8 00001027296WK1 00001028115WK2 00001028021WK2 00001027466WK0 00001027996WK6 000",,"458 (306 US; 152 OUS)","GE Healthcare conducted a recall on various mobile x-ray units (Optima XR220amx, Optima XR200amx, and Brivo XR285amx systems) because of an Erratic Drive Performance.",8/7/2012,"08/07/2012",8/21/2013,"08/21/2013"
"Devices",64993,"Ongoing","SpineFrontier, Inc.","Beverly","MA","US","Voluntary: Firm Initiated","E-Mail","US Distribution including the states of MA, NV and TX.","Z-1932-2013","Class II","T-Handle, Strike Plate, Push Connection, Part Number: SI50023 Rev A T-handles are silicone handled instruments that have a quick release end. The silicone T-handle has an impactor cap on the proximal end of the handle which is designed to be struck with a mallet. T-handles are used primarily to attach to, and operate a wide range of instruments used during implantation of spinal intervertebral body fusion devices intended for intervertebral body fusion of the spine of skeletally mature patients. ","Lot Numbers: 1335201A, 1446101A",".","11","During an operation the strike plate of a T-Handle loosened and separated from the T-Handle. ",8/29/2012,"08/29/2012",8/14/2013,"08/14/2013"
"Devices",64994,"Ongoing","SpineFrontier, Inc.","Beverly","MA","US","Voluntary: Firm Initiated","E-Mail","Distributed in DC and the states of MA, and OK.","Z-1957-2013","Class II","Invue Solid Driver, Tipped, AO. Part Number: 11-70083. Allows the user to retain the screw when changing axis of insertion during fixation of spinal intervertebral. ","Lot Number: 011836-0001, 011981-001",,"9","The nipple of the tipped driver broke off when surgeons were attempting to insert the screw. ",5/9/2012,"05/09/2012",8/21/2013,"08/21/2013"
"Drugs",64995,"Ongoing","Glenmark Generics Inc., USA","Mahwah","NJ","US","Voluntary: Firm Initiated","Letter","Nationwide","D-330-2013","Class III","Glenmark Pravastatin Sodium Tablets ,40 mg, 90-count bottle (NDC 68462-197-90), Rx only, Manufactured by Glenmark Generics Ltd.Colvale- Bardez Ltd 403513, India Manufactured for :Glenmark Generics USA Mahwah, NJ 07430 ","Lot # 02121059 Exp 03/15 Lot # 02121484 Exp 04/15 Lot # 02121530 Exp 04/15 Lot# 02121665 Exp 05/15 Lot# 02121669 Exp 05/15 Lot# 02121689 Exp 05/15 Lot# 02121705 Exp 05/15 Lot# 02123434 Exp 10/15 Lot# 02123446 Exp 10/15 Lot# 02123633 Exp 11/15 Lot# 02123677 Exp 11/15 Lot# 02123685 Exp 11/15 Lot# 02123695 Exp 11/15 Lot# 02123823 Exp 11/15 Lot# 02123833 Exp 11/15 Lot# 02123836 Exp 11/15 Lot# 02123853 Exp 11/15 Lot# 02123859 Exp 11/15 Lot# 02130021 Exp 12/15 Lot# 02130059 Exp 12/15 Lot# 02130079 Exp 12/15 ",,"246,528 bottles","Chemical Contamination: Pravastatin Sodium Tablets isbeing recalled due to complaints related to an off-odor described as moldy, musty or fishy in nature.",4/5/2013,"04/05/2013",5/22/2013,"05/22/2013"
"Drugs",64995,"Ongoing","Glenmark Generics Inc., USA","Mahwah","NJ","US","Voluntary: Firm Initiated","Letter","Nationwide","D-331-2013","Class III","Glenmark Topiramate Tablets, 200 mg, 60-count bottle, (NDC 68462-110-60), Rx only, Manufactured by Glenmark Generics Ltd.Colvale- Bardez Ltd 403513, India Manufactured for : Glenmark Generics USA Mahwah, NJ 07430 ","Lot# 02123782, Exp 11/14",,"9624 bottles","Chemical Contamination: Topiramate Tablets is being recalled due to complaints related to an off - odor. described as moldy, musty or fishy in nature.",4/5/2013,"04/05/2013",5/22/2013,"05/22/2013"
"Drugs",64995,"Ongoing","Glenmark Generics Inc., USA","Mahwah","NJ","US","Voluntary: Firm Initiated","Letter","Nationwide","D-329-2013","Class III","Glenmark Gabapentin Tablets, a) 600mg, 500- count bottle (NDC 68462-126-05), b) 800 mg, 500- count bottle (NDC 68462-127-05), Rx only, Manufactured by Glenmark Generics Ltd.Colvale- Bardez Ltd 403513, India, Manufactured for : Glenmark Generics USA Mahwah, NJ 07430. ","a) 600mg: Lot# 02123419, Exp 10/14 Lot# 02123424, Exp 10/14 Lot# 02123430, Exp 10/14 Lot# 02123492, Exp 10/14 Lot# 02123523, Exp 10/14 Lot# 02123527, Exp 10/14 Lot# 02123532, Exp 10/14 Lot# 02123542, Exp 10/14 Lot# 02123546, Exp 10/14 Lot# 02123551, Exp 10/14 Lot# 02123555, Exp 10/14 Lot# 02123560, Exp 11/14 Lot# 02123566, Exp 11/14 Lot# 02123569, Exp 11/14 b) 800 mg Lot# 02123440 Exp 10/14 Lot# 02123445 Exp 10/14 Lot# 02123454 Exp 10/14 Lot# 02123465 Exp 10/14 Lot# 02123789 Exp 11/14 Lot# 02123804 Exp 11/14 Lot# 02123821 Exp 11/14 Lot# 02123829 Exp 11/14 Lot# 02123834 Exp 11/14 Lot# 02123841 Exp 11/14 Lot# 02123845 Exp 11/14 ",,"a) 33,138 bottles (500ct) ; b)19,278 bottles (500 ct)","Chemical Contamination: Gabapentin Sodium tablets is recalled due to complaints related to an off - odor described as moldy, musty or fishy in nature.",4/5/2013,"04/05/2013",5/22/2013,"05/22/2013"
"Drugs",64996,"Completed","Physicians Total Care, Inc.","Tulsa","OK","US","Voluntary: Firm Initiated","FAX","MO","D-499-2013","Class III","Camila 0.35 mg Tablets, 6 cards of 28 pills, Dist. By: Physicians Total Care, Tulsa, OK --- NDC 54868-4814-0, MFG By TEVA Pharmaceuticals USA, Sellersville, PA","Physicians Total Care Lots: 6Z4C Exp. 10/31/2013 ",".","6 cards of 28 tablets","Failed Impurity/Degradation Specification; an impurity identified as N-Butyl-Benzene Sulfonamide (NBBS) was detected during impurity testing ",3/18/2013,"03/18/2013",6/5/2013,"06/05/2013"
"Devices",64997,"Terminated","Varian Medical Systems, Inc. Oncology Systems","Palo Alto","CA","US","Voluntary: Firm Initiated","Letter","Worldwide distribution - USA (nationwide) including Puerto Rico, and countries of: Algeria, Angola, Australia, Austria, Bahrain, Bangladesh, Belarus, Belguim, Brazil, Bosnia and Hezregovina, Bulgaria, Canada, Chile, China, Columbia, Cyprus, Denmark, Dominican Republic, Ecuador, Egypt, Estonia, Finland, Frances, French Polynesia, Georgia, Germany, Greece, Gaudaloupe, Gaum, Hong Kong, India, Indonesia, Ireland, Italy, Israel, Latvia, Lithuania, Luxemburg, Japan, Kazarhstan, Kuwait, Lebanon, Macau, Macedonia, Malaysia, Martinique, Mauritania, Mexico, Moldova, Monaco, Morroco, Nepal, Netherlands, New Zealand, Norway, Oman, Pakistan, Panama, Peru, Phillipines, Poland, Portugal, Qatar, Reunion, Romania, Russia, Saudia Arabia, Serbia, Singapore, Slovakia, Spain, South Africa, South Korea, Sri Lanka, Syria, Sweden, Switzerland, Taiwan, Thailand, Trinidad and Tobago, Tunisia, Turkey, Ukraine, United Arab Emirates, United Kingdom, Uruguay, Venezula, Vietnam, and Zimbabwe.","Z-1325-2013","Class II","Varian High Energy Clinacs, High Energy Accelerator, Radiation Treatment System, Model Numbers: H14, H27,H29, HCX, Product Usage: The Varian High Energy Accelerator is intended to provide stereotactic radiosurgery and precision radiotherapy for lesions, tumors and conditions anywhere in the body when radiation treatment is indicated. ","CODES: H140001 H140064 H140137 H140721 H140796 H140862 H260947 H270267 H270428 H270539 H270708 H270828 H271017 H140002 H140065 H140139 H140723 H140797 H140863 H260949 H270271 H270430 H270540 H270709 H270829 H271018 H140003 H140066 H140141 H140724 H140798 H140865 H260950 H270273 H270431 H270542 H270710 H270833 H271019 H140004 H140067 H140143 H140725 H140799 H140866 H260951 H270277 H270435 H270544 H270711 H270836 H271020 H140005 H140068 H140144 H140726 H140800 H140868 H260952 H270280 H270437 H270547 H270712 H270837 H271021 H140006 H140069 H140145 H140727 H140801 H140869 H260953 H270281 H270438 H270550 H270714 H270838 H271023 H140007 H140070 H140146 H140729 H140803 H140871 H270004 H270282 H270439 H270601 H270716 H270840 H271024 H140008 H140071 H140147 H140731 H140804 H140872 H270006 H270285 H270443 H270602 H270718 H270841 H271026 H140009 H140073 H140148 H140733 H140805 H140873 H270009 H270290 H270445 H270607 H270719 H270842 H271031 H140010 H140074 H140150 H140734 H140806 H140874 H270010 H270293 H270446 H270613 H270725 H270844 H271032 H140011 H140075 H140151 H140737 H140807 H140877 H270021 H270297 H270447 H270615 H270726 H270845 H271034 H140012 H140077 H140152 H140738 H140808 H140878 H270026 H270302 H270448 H270622 H270727 H270846 H271035 H140014 H140078 H140153 H140739 H140809 H140879 H270027 H270303 H270451 H270623 H270728 H270852 H271037 H140015 H140080 H140154 H140740 H1408095 H140882 H270029 H270307 H270452 H270624 H270732 H270854 H271038 H140016 H140082 H140201 H140742 H140810 H140883 H270030 H270310 H270454 H270625 H270733 H270855 H271039 H140017 H140083 H140202 H140743 H140811 H140885 H270038 H270314 H270455 H270627 H270735 H270857 H271041 H140018 H140084 H140203 H140744 H140812 H140886 H270045 H270323 H270458 H270631 H270736 H270858 H271043 H140019 H140086 H140204 H140745 H140813 H140889 H270047 H270324 H270461 H270632 H270737 H270859 H271044 H140021 H140088 H140206 H140746 H140814 H140890 H270073 H270329 H270462 H270633 H270739 H270861 H271051 H140022 H140090 H140207 H140747 H140815 H140891 H270079 H2703"," H294696 H294783 H294894 H293920 H294005 H294091 H294175 H294255 H294333 H294422 H294503 H294598 H294698 H294784 H294895 H293921 H294006 H294092 H294176 H294256 H294334 H294423 H294504 H294599 H294700 H294787 H294896 H293922 H294007 H294093 H294177 H294257 H294336 H294425 H294505 H294600 H294701 H294789 H294899 H293925 H294008 H294094 H294180 H294258 H294337 H294426 H294508 H294601 H294702 H294790 H294901 H293927 H294009 H294095 H294181 H294259 H294338 H294427 H294509 H294602 H294705 H294792 H294902 H293930 H294010 H294097 H294182 H294260 H294339 H294428 H294511 H294603 H294706 H294793 H294903 H293931 H294011 H294098 H294183 H294261 H294340 H294429 H294512 H294604 H294709 H294794 H294904 H293932 H294012 H294100 H294184 H294262 H294341 H294430 H294514 H294605 H294710 H294795 H294905 H293933 H294013 H294101 H294185 H294263 H294345 H294432 H294515 H294606 H294711 H294798 H294911 H293934 H294014 H294102 H294186 H294264 H294346 H294433 H294516 H294607 H294713 H294799 H294912 H293935 H294015 H294103 H294187 H294265 H294347 H294434 H294517 H294610 H294714 H294800 H294915 H293936 H294016 H294104 H294188 H294266 H294348 H294435 H294518 H294616 H294715 H294802 H294916 H293937 H294017 H294105 H294190 H294267 H294349 H294437 H294520 H294617 H294717 H294803 H294917 H293938 H294020 H294106 H294191 H294269 H294350 H294439 H294521 H294618 H294718 H294806 H294918 H293940 H294021 H294107 H294192 H294270 H294351 H294440 H294522 H294619 H294719 H294807 H294919 H293941 H294022 H294108 H294195 H294271 H294358 H294441 H294523 H294623 H294720 H294808 H294920 H293943 H294023 H294110 H294196 H294272 H294361 H294443 H294524 H294624 H294721 H294810 H294922 H293944 H294025 H294114 H294197 H294273 H294362 H294445 H294526 H294625 H294723 H294811 H294924 H293946 H294027 H294117 H294198 H294274 H294363 H294446 H294527 H294626 H294724 H294813 H294925 H293947 H294028 H294118 H294200 H294278 H294365 H294447 H294528 H294627 H294726 H294815 H294927 H293948 H294031 H294121 H294201 H294279 H294366 H294448 H294529 H294628 H294727 H294818 H294929 H293","3943 units","Varian has identified that under certain conditions, photon beams in High Energy Clinacs may experience a gradual change in beam symmetry, potentially reaching an asymmetry of up to approximately 7% before interlock occurs. At maximum asymmetry, this may result in no more than approximately 3.5% dose deviation from expected at any point in the beam, and may result in minor injury to the patient or slightly decreased local disease control.",5/31/2011,"05/31/2011",5/22/2013,"05/22/2013"
"Biologics",64999,"Terminated","Department of Air Force - BB/HT","Lackland A F B","TX","US","Voluntary: Firm Initiated","Telephone","TX","B-1731-13","Class II","Platelets Pheresis Leukocytes Reduced","W001313200265",".","1 unit","Blood product, which did not meet the acceptable product specifications for release, was distributed.",2/27/2013,"02/27/2013",8/28/2013,"08/28/2013"
"Biologics",65000,"Terminated","Medic Inc","Knoxville","TN","US","Voluntary: Firm Initiated","E-Mail","Switzerland","B-1732-13","Class III","Blood and Blood Products for Reprocessing","W071212065186",".","1 unit","Blood product, which did not meet the acceptable product specifications, was distributed.",4/9/2013,"04/09/2013",8/28/2013,"08/28/2013"
"Biologics",65001,"Terminated","LifeServe Blood Center","Des Moines","IA","US","Voluntary: Firm Initiated","Telephone","SD","B-1730-13","Class II","Platelets Pheresis Leukocytes Reduced","W044113009725",".","1 unit","Blood product, which did not meet the acceptable product specifications for release, was distributed",4/1/2013,"04/01/2013",8/28/2013,"08/28/2013"
"Drugs",65002,"Completed","Physicians Total Care, Inc.","Tulsa","OK","US","Voluntary: Firm Initiated","FAX","FL","D-301-2013","Class III","Percocet 10/325 mg tablets, 100-count tablets per bottle, Rx only, Dist. By: Physicians Total Care, Tulsa, OK 74146; Mfg. By: Novartis Consumer Health I, Lincoln, NE 68581; NDC 54868-4710-0, Barcode 47101006IHD.","Lot # 6IHD, Exp 09/30/2013 ",,"1 bottle","Presence of Foreign Tablets/Capsules: One bottle of Percocet 10/325 mg was found to contain a tablet of Endocet 10/25 mg, the generic form.",5/23/2011,"05/23/2011",5/8/2013,"05/08/2013"
"Food",65003,"Ongoing","7-Eleven Stores of Oklahoma","Oklahoma City","OK","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Oklahoma","F-1453-2013","Class I","7th Heaven Bakeries Oatmeal Raisin Cookie, 7th Heaven Bakeries, Oklahoma City, OK","Best By Dates prior to 05/07/13.",".","1,873 cookies","Undeclared egg, soy and milk.",4/23/2013,"04/23/2013",6/5/2013,"06/05/2013"
"Drugs",65004,"Completed","Physicians Total Care, Inc.","Tulsa","OK","US","Voluntary: Firm Initiated","FAX","NC","D-317-2013","Class III","Plavix 75 mg, 30 count bottle, NDC (54868-4070-0), Rx only, Manufactured by Bristol-Meyers Squibb, Bridgewater, NJ 08807, Distributed by Physicians Total Care, Tulsa, OK 74146.","Lot # 67JV Exp 08/13",".","60 tablets","Chemical Contamination: Uncharacteristic moldy odor due to presence of 2,4,6-tribromoanisole (TBA).",2/8/2011,"02/08/2011",5/15/2013,"05/15/2013"
"Devices",65005,"Completed","Biomet 3i, LLC","Palm Beach Gardens","FL","US","Voluntary: Firm Initiated","Letter","Distribution to the state of Massachusetts, and the foreign countries of Australia, Belgium, Spain, Denmark, France, Luxembourg, Switzerland, Germany, Bonaire, Sweden, and Italy.","Z-1961-2013","Class II","Biomet 3i Dental Implant, Non-Platform Switched Parallel Walled Implant 5mm (D) x 13mm (L) ","Lot number: 2012101530 Exp 2017/12 Catalog #: BNSS513",,"33","A small number of outer implant boxes may be mislabeled. The inner tray, containing the implant, is label correctly. This condition, if present and not recognized could potentially result in the dental implant not being able to be placed into the osteotomy or seated to the desired depth if placement is attempted.",5/10/2013,"05/10/2013",8/21/2013,"08/21/2013"
"Devices",65005,"Completed","Biomet 3i, LLC","Palm Beach Gardens","FL","US","Voluntary: Firm Initiated","Letter","Distribution to the state of Massachusetts, and the foreign countries of Australia, Belgium, Spain, Denmark, France, Luxembourg, Switzerland, Germany, Bonaire, Sweden, and Italy.","Z-1960-2013","Class II","Biomet 3i Dental Implant, Parallel Walled 6mm (D) x 10mm (L)","Lot number: 2012111613 Exp 2017/12 Catalog #: BOPS6510",,"51","A small number of outer implant boxes may be mislabeled. The inner tray, containing the implant, is label correctly. This condition, if present and not recognized could potentially result in the dental implant not being able to be placed into the osteotomy or seated to the desired depth if placement is attempted.",5/10/2013,"05/10/2013",8/21/2013,"08/21/2013"
"Devices",65006,"Ongoing","Alcon Grieshaber AG","Schaffhausen",,"CH","Voluntary: Firm Initiated","Letter","Worldwide distribution: US (nationwide) and countries of: Argentina, Australia, Austria, Belgium, Canada, Chile, China, Egypt, France, Germany, Great Britain, India, Ireland, Israel, Italy, Japan, Kazakhstan, Kuwait, Kyrgyzstan, Lebanon, Korea, Malaysia, Mexico, Pakistan, Peru, Russia, Saudi Arabia, Singapore, South Africa, Spain, Sweden, Switzerland, Taiwan, Turkey, Turknenistan, Venezula, and Viet Nam.","Z-1506-2013","Class II","The Constellation Vision System Pneumatic Handpiece. Indicated for both anterior and posterior segment opthalmic surgery. ","All Lots of the Constellation Vision System Pneumatic Handpiece, DSP, product number 725.01",".","8,455 units","Alcon is conducting a Medical Device Removal for the Constellation Pneumatic Handpiece, DSP, product number 725.01. This action is being taken because the forceps or scissors tips (sold separately) may dislodge from the hand piece, if not attached by the user according to the Directions for Use.",4/17/2013,"04/17/2013",6/12/2013,"06/12/2013"
"Drugs",65008,"Ongoing","Mylan Pharmaceuticals Inc.","Morgantown","WV","US","Voluntary: Firm Initiated","Letter","Nationwide","D-500-2013","Class II","Ropinirole hydrochloride tablets, USP 4 mg, 100-count bottle (NDC 0378-5504-01), Rx only, Manufactured for: Mylan Pharmaceuticals, Inc., Morgantown, WV 26505 U.S.A. Made in India ","Lot # ZRMB11004, Exp 09/13",".","3,048 bottles ","Labeling: Label Error on Declared Strength- Unopened bottles of Ropinirole USP 3 mg tablets was found to be incorrectly labeled as Ropinirole USP 4 mg tablets..",4/22/2013,"04/22/2013",6/5/2013,"06/05/2013"
"Devices",65009,"Ongoing","Synthes USA HQ, Inc.","West Chester","PA","US","Voluntary: Firm Initiated","Letter","Nationwide Distribution including CA,and VA. .","Z-2278-2013","Class II","Synthes 3.5 MM LCP(R) Distal Humerus System The Synthes 3.5 MM LCP Distal Humerus System is intended for fixation of fractures of the distal humerus, olecranon, and ulna in adults and adolescents (12-21) in which the growth plates have fused. Specifically, distal humerus plates are indicated for intra-articular fractures, comminuted supracondylar fractures, osteotomies, malunions and non-unions of the distal humerus.","Part Number 241.267, lot number 8037923",".","2","Recall is being initiated due to the part being mislabeled (Part Number 241.267 was mislabeled with Part Number 241.276).",3/8/2013,"03/08/2013",10/2/2013,"10/02/2013"
"Biologics",65010,"Terminated","OneBlood / dba CBCF","Lauderhill","FL","US","Voluntary: Firm Initiated","Telephone","FL","B-1733-13","Class II","Platelets Pheresis Leukocytes Reduced","W036813047271",".","1 unit","Blood product, which did not meet acceptable product specifications, was distributed.",3/8/2013,"03/08/2013",8/28/2013,"08/28/2013"
"Biologics",65011,"Terminated","LifeShare Blood Centers","Shreveport","LA","US","Voluntary: Firm Initiated","Letter","Louisiana","B-2005-13","Class II","Red Blood Cells (Apheresis) Leukocytes Reduced","W036512129561; W036512129561",,"2 units","Blood products, collected from a donor who had recently visited a malarial endemic region, were distributed. ",4/17/2013,"04/17/2013",8/7/2013,"08/07/2013"
"Biologics",65012,"Terminated","LifeShare Blood Centers","Shreveport","LA","US","Voluntary: Firm Initiated","Letter","Louisiana","B-1835-13","Class II","Red Blood Cells Leukocytes Reduced","W036512158305",,"1 unit","Blood product, collected from a donor who had recently visited a malarial endemic region, was distributed. ",4/16/2013,"04/16/2013",8/7/2013,"08/07/2013"
"Biologics",65013,"Terminated","Inland Northwest Blood Center","Spokane","WA","US","Voluntary: Firm Initiated","Telephone","Switzerland; WA; CA","B-1736-13","Class II","Red Blood Cells Leukocytes Reduced","W0685133202186; W068513390157Z",".","2 units","Blood products, collected from a donor whose suitability to donate was not adequately determined, were distributed.",3/6/2013,"03/06/2013",8/28/2013,"08/28/2013"
"Biologics",65013,"Terminated","Inland Northwest Blood Center","Spokane","WA","US","Voluntary: Firm Initiated","Telephone","Switzerland; WA; CA","B-1737-13","Class III","Blood and Blood Products for Reprocessing","W0685133202186; W068513390157Z",".","2 units","Blood products, collected from a donor whose suitability to donate was not adequately determined, were distributed",3/6/2013,"03/06/2013",8/28/2013,"08/28/2013"
"Biologics",65013,"Terminated","Inland Northwest Blood Center","Spokane","WA","US","Voluntary: Firm Initiated","Telephone","Switzerland; WA; CA","B-1735-13","Class II","Cryoprecipitated AHF","W068513390157Z",".","1 unit","Blood products, collected from a donor whose suitability to donate was not adequately determined, were distributed.",3/6/2013,"03/06/2013",8/28/2013,"08/28/2013"
"Biologics",65014,"Terminated","Blood Systems, Inc.","Las Vegas","NV","US","Voluntary: Firm Initiated","Telephone","NV","B-1896-13","Class II","Platelets Pheresis Leukocytes Reduced","W041912047393C- part 3 ",".","1 unit","Blood products, which did not meet acceptable product specifications, were distributed.",3/13/2013,"03/13/2013",8/28/2013,"08/28/2013"
"Biologics",65014,"Terminated","Blood Systems, Inc.","Las Vegas","NV","US","Voluntary: Firm Initiated","Telephone","NV","B-1897-13","Class II","Platelets Pheresis Leukocytes Reduced Irradiated","W041912047393C-part 1; W041912047393C-part 2",".","2 units","Blood products, which did not meet acceptable product specifications, were distributed.",3/13/2013,"03/13/2013",8/28/2013,"08/28/2013"
"Biologics",65016,"Terminated","OneBlood / dba CBCF","Lauderhill","FL","US","Voluntary: Firm Initiated","Telephone","Florida","B-1898-13","Class II","Platelets Pheresis Leukocytes Reduced","W036812635828- part A; W036812635828- part B ",".","2 units","Blood products, which did not meet the acceptable product specifications, were distributed.",1/25/2013,"01/25/2013",9/11/2013,"09/11/2013"
"Drugs",65017,"Ongoing","Hi-Tech Pharmacal Co., Inc.","Amityville","NY","US","Voluntary: Firm Initiated","Letter","Nationwide and Puerto Rico","D-302-2013","Class III","Acetic Acid Otic Solution, USP, 15 mL bottle, Rx Only, Hi-Tech Pharmacal Co., Inc., Amityville, N.Y. 11701, NDC 50383-889-15, UPC 3 50383-889-15 1.","Lot #: 610593, Exp 06/13",,"11,472 bottles","Subpotent Drug: The product/lot is out-of-specification (OOS) for the assay of acetic acid at the 18-month test station.",3/11/2013,"03/11/2013",5/8/2013,"05/08/2013"
"Devices",65018,"Ongoing","Chicago X-Ray Systems, Inc.","Prospect Heights","IL","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution- USA (nationwide) and Latin America.","Z-1179-2013","Class II","Fona Srl IntraOs 70 intra-oral x-ray system IntraOS 70 is an extra oral source X-ray system for dental radiographic examination and diagnosis of diseases of the teeth.","Model IntraOs 70 ",".","1960 units ","The IntraOs 70 system was found to have missing or incomplete system labels as required by 21 CFR 1010.2 & 1010.3. Also, the user's manual was found to have missing or improperly labeled information as required by 21 CFR 1020.30(h). ",7/3/2012,"07/03/2012",5/29/2013,"05/29/2013"
"Drugs",65019,"Ongoing","Nora Apothecary and Alternative Therapies, Inc.","Indianapolis","IN","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Nationwide","D-459-2013","Class II","PGE-1 Inj 30mcg/ml MDV, 7 ml Penile Injection, 90 day expiration, ","All products within their expiration date including those dated 90 days prior to April 19, 2013 (Jan. 2013 to April 19, 2013). ",".",,"Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes.",4/22/2013,"04/22/2013",6/5/2013,"06/05/2013"
"Drugs",65019,"Ongoing","Nora Apothecary and Alternative Therapies, Inc.","Indianapolis","IN","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Nationwide","D-485-2013","Class II","Methylcobalamin 5mg/ml Inj Syr, 10x0.4syr Subcutaneous, 90 day expiration, ","All products within their expiration date including those dated 90 days prior to April 19, 2013 (Jan. 2013 to April 19, 2013). ",".","2","Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes.",4/22/2013,"04/22/2013",6/5/2013,"06/05/2013"
"Drugs",65019,"Ongoing","Nora Apothecary and Alternative Therapies, Inc.","Indianapolis","IN","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Nationwide","D-488-2013","Class II","Hydroxyprogesterone Inj 250mg/ml MDV, 5 ml Intramuscular, 30 day expiration, ","All products within their expiration date including those dated 90 days prior to April 19, 2013 (Jan. 2013 to April 19, 2013). ",".","5","Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes.",4/22/2013,"04/22/2013",6/5/2013,"06/05/2013"
"Drugs",65019,"Ongoing","Nora Apothecary and Alternative Therapies, Inc.","Indianapolis","IN","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Nationwide","D-455-2013","Class II","Bimix Inj 30:1 MDV: 5ml, 10 ml, 3x10ml, 2x10ml Penile Injection, 30 and 90 day expiration, ","All products within their expiration date including those dated 90 days prior to April 19, 2013 (Jan. 2013 to April 19, 2013). ",".","128","Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes.",4/22/2013,"04/22/2013",6/5/2013,"06/05/2013"
"Drugs",65019,"Ongoing","Nora Apothecary and Alternative Therapies, Inc.","Indianapolis","IN","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Nationwide","D-457-2013","Class II","PGE-1 Inj 10mcg/ml MDV, 5ml Penile Injection, 90 day expiration, ","All products within their expiration date including those dated 90 days prior to April 19, 2013 (Jan. 2013 to April 19, 2013). ",".",,"Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes.",4/22/2013,"04/22/2013",6/5/2013,"06/05/2013"
"Drugs",65019,"Ongoing","Nora Apothecary and Alternative Therapies, Inc.","Indianapolis","IN","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Nationwide","D-460-2013","Class II","PGE-1 Inj 40mcg/ml MDV, 5 ml Penile Injection, 90 day expiration, ","All products within their expiration date including those dated 90 days prior to April 19, 2013 (Jan. 2013 to April 19, 2013). ",".","2","Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes.",4/22/2013,"04/22/2013",6/5/2013,"06/05/2013"
"Drugs",65019,"Ongoing","Nora Apothecary and Alternative Therapies, Inc.","Indianapolis","IN","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Nationwide","D-463-2013","Class II","Trimix Inj 30:1:40 MDV, 5 ml Penile Injection, 30 and 90 day expiration, ","All products within their expiration date including those dated 90 days prior to April 19, 2013 (Jan. 2013 to April 19, 2013). ",".",,"Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes.",4/22/2013,"04/22/2013",6/5/2013,"06/05/2013"
"Drugs",65019,"Ongoing","Nora Apothecary and Alternative Therapies, Inc.","Indianapolis","IN","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Nationwide","D-491-2013","Class II","Glutathione 200mg/ml Inj SDV: 3x50ml 14 day expiration, 1x50ml 21 day expiration","All products within their expiration date including those dated 90 days prior to April 19, 2013 (Jan. 2013 to April 19, 2013). ",".","2","Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes.",4/22/2013,"04/22/2013",6/5/2013,"06/05/2013"
"Drugs",65019,"Ongoing","Nora Apothecary and Alternative Therapies, Inc.","Indianapolis","IN","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Nationwide","D-461-2013","Class II","Trimix Inj 30:1:10 MDV, 5 ml Penile Injection, 30 and 90 day expiration, ","All products within their expiration date including those dated 90 days prior to April 19, 2013 (Jan. 2013 to April 19, 2013). ",".","2","Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes.",4/22/2013,"04/22/2013",6/5/2013,"06/05/2013"
"Drugs",65019,"Ongoing","Nora Apothecary and Alternative Therapies, Inc.","Indianapolis","IN","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Nationwide","D-490-2013","Class II","Gentamicin 24mg/60ml Irrigation, 15x60ml Syr Irrigation, 14 day expiration, ","All products within their expiration date including those dated 90 days prior to April 19, 2013 (Jan. 2013 to April 19, 2013). ",".",,"Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes.",4/22/2013,"04/22/2013",6/5/2013,"06/05/2013"
"Drugs",65019,"Ongoing","Nora Apothecary and Alternative Therapies, Inc.","Indianapolis","IN","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Nationwide","D-486-2013","Class II","Methylcobalamin Inj 2.5mg/ml MDV, 10 ml Subcutaneous, 90 day expiration, ","All products within their expiration date including those dated 90 days prior to April 19, 2013 (Jan. 2013 to April 19, 2013). ",".","3","Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes.",4/22/2013,"04/22/2013",6/5/2013,"06/05/2013"
"Drugs",65019,"Ongoing","Nora Apothecary and Alternative Therapies, Inc.","Indianapolis","IN","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Nationwide","D-467-2013","Class II","Vancomycin Opth Soln 25mg/ml PF, 10ml Opthalmic Soln, 10 day expiration, ","All products within their expiration date including those dated 90 days prior to April 19, 2013 (Jan. 2013 to April 19, 2013). ",".","2","Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes.",4/22/2013,"04/22/2013",6/5/2013,"06/05/2013"
"Drugs",65019,"Ongoing","Nora Apothecary and Alternative Therapies, Inc.","Indianapolis","IN","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Nationwide","D-456-2013","Class II","Papaverine Inj 30mg/ml Syr, 5mlsyr, 10mlsyr,10x0.95mlsyr Penile Injection, 90 day expiration, ","All products within their expiration date including those dated 90 days prior to April 19, 2013 (Jan. 2013 to April 19, 2013). ",".","8","Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes.",4/22/2013,"04/22/2013",6/5/2013,"06/05/2013"
"Drugs",65019,"Ongoing","Nora Apothecary and Alternative Therapies, Inc.","Indianapolis","IN","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Nationwide","D-492-2013","Class II","M.I.C.+B12 Inj MDV: 3x50ml, 4x50 ml 90 day expiration, ","All products within their expiration date including those dated 90 days prior to April 19, 2013 (Jan. 2013 to April 19, 2013). ",".","2","Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes.",4/22/2013,"04/22/2013",6/5/2013,"06/05/2013"
"Drugs",65019,"Ongoing","Nora Apothecary and Alternative Therapies, Inc.","Indianapolis","IN","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Nationwide","D-453-2013","Class II","Bimix Inj 30 :1 Syr, 12x1.5 ml syr, 10x1.2 ml syr, 2x2 ml syr, 2x1 ml syr, 12x.05 ml syr Penile Injection,30 and 90 day expiration, ","All products within their expiration date including those dated 90 days prior to April 19, 2013 (Jan. 2013 to April 19, 2013). ",".","5","Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes.",4/22/2013,"04/22/2013",6/5/2013,"06/05/2013"
"Drugs",65019,"Ongoing","Nora Apothecary and Alternative Therapies, Inc.","Indianapolis","IN","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Nationwide","D-466-2013","Class II","Super Trimix #1 Inj MDV, 12 ml Penile Injection, 90 day expiration, ","All products within their expiration date including those dated 90 days prior to April 19, 2013 (Jan. 2013 to April 19, 2013). ",".","1","Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes.",4/22/2013,"04/22/2013",6/5/2013,"06/05/2013"
"Drugs",65019,"Ongoing","Nora Apothecary and Alternative Therapies, Inc.","Indianapolis","IN","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Nationwide","D-462-2013","Class II","Trimix Inj 30:1:20 MDV: 5 ml, 10 ml, 2x5 ml Penile Injection, 30 and 90 day expiration, ","All products within their expiration date including those dated 90 days prior to April 19, 2013 (Jan. 2013 to April 19, 2013). ",".","72","Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes.",4/22/2013,"04/22/2013",6/5/2013,"06/05/2013"
"Drugs",65019,"Ongoing","Nora Apothecary and Alternative Therapies, Inc.","Indianapolis","IN","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Nationwide","D-487-2013","Class II","Methylcobalamin Inj 25mg/ml Syr: 8x0.06mlsyr, 10x0.06 ml syr, 12x0.06 ml syr Subcutaneous, 30 and 90 day expiration, ","All products within their expiration date including those dated 90 days prior to April 19, 2013 (Jan. 2013 to April 19, 2013). ",".","5","Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes.",4/22/2013,"04/22/2013",6/5/2013,"06/05/2013"
"Drugs",65019,"Ongoing","Nora Apothecary and Alternative Therapies, Inc.","Indianapolis","IN","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Nationwide","D-479-2013","Class II","HCG Inj 500un/ml MDV, 5 ml Subcutaneous, 30 day expiration, ","All products within their expiration date including those dated 90 days prior to April 19, 2013 (Jan. 2013 to April 19, 2013). ",".",,"Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes.",4/22/2013,"04/22/2013",6/5/2013,"06/05/2013"
"Drugs",65019,"Ongoing","Nora Apothecary and Alternative Therapies, Inc.","Indianapolis","IN","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Nationwide","D-470-2013","Class II","Tobramycin Opth Soln 14mg/ml, 7ml Opthalmic Soln, 10 day expiration, ","All products within their expiration date including those dated 90 days prior to April 19, 2013 (Jan. 2013 to April 19, 2013). ",".",,"Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes.",4/22/2013,"04/22/2013",6/5/2013,"06/05/2013"
"Drugs",65019,"Ongoing","Nora Apothecary and Alternative Therapies, Inc.","Indianapolis","IN","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Nationwide","D-483-2013","Class II","Methylcobalamin Inj 1mg/ml MDV, 10 ml, 15 ml, 20 ml, 30 ml, 4x30 ml Subcutaneous, 90 day expiration, ","All products within their expiration date including those dated 90 days prior to April 19, 2013 (Jan. 2013 to April 19, 2013). ",".","14","Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes.",4/22/2013,"04/22/2013",6/5/2013,"06/05/2013"
"Drugs",65019,"Ongoing","Nora Apothecary and Alternative Therapies, Inc.","Indianapolis","IN","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Nationwide","D-472-2013","Class II","Chlorhexidine Opth Soln 0.02%, 10 ml Opthalmic Soln, 30 day expiration, ","All products within their expiration date including those dated 90 days prior to April 19, 2013 (Jan. 2013 to April 19, 2013). ",".","1","Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes.",4/22/2013,"04/22/2013",6/5/2013,"06/05/2013"
"Drugs",65019,"Ongoing","Nora Apothecary and Alternative Therapies, Inc.","Indianapolis","IN","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Nationwide","D-475-2013","Class II","Folic Acid Inj 5mg/ml MDV, 10 ml Subcutaneous, 90 day expiration, ","All products within their expiration date including those dated 90 days prior to April 19, 2013 (Jan. 2013 to April 19, 2013). ",".",,"Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes.",4/22/2013,"04/22/2013",6/5/2013,"06/05/2013"
"Drugs",65019,"Ongoing","Nora Apothecary and Alternative Therapies, Inc.","Indianapolis","IN","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Nationwide","D-477-2013","Class II","HCG Inj 1200un/ml MDV, 10 ml Subcutaneous, 30 day expiration, ","All products within their expiration date including those dated 90 days prior to April 19, 2013 (Jan. 2013 to April 19, 2013). ",".","3","Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes.",4/22/2013,"04/22/2013",6/5/2013,"06/05/2013"
"Drugs",65019,"Ongoing","Nora Apothecary and Alternative Therapies, Inc.","Indianapolis","IN","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Nationwide","D-471-2013","Class II","Tobramycin Opth Soln 13mg/ml, 7ml Opthalmic Soln, 10 day expiration, ","All products within their expiration date including those dated 90 days prior to April 19, 2013 (Jan. 2013 to April 19, 2013). ",".",,"Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes.",4/22/2013,"04/22/2013",6/5/2013,"06/05/2013"
"Drugs",65019,"Ongoing","Nora Apothecary and Alternative Therapies, Inc.","Indianapolis","IN","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Nationwide","D-469-2013","Class II","Vancomycin Opth Soln14mg/ml PF, 10ml Opthalmic Soln, 30 day expiration, ","All products within their expiration date including those dated 90 days prior to April 19, 2013 (Jan. 2013 to April 19, 2013). ",".","1","Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes.",4/22/2013,"04/22/2013",6/5/2013,"06/05/2013"
"Drugs",65019,"Ongoing","Nora Apothecary and Alternative Therapies, Inc.","Indianapolis","IN","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Nationwide","D-468-2013","Class II","Vancomycin Opth Soln 30mg/ml PRES, 10ml Opthalmic Soln, 30 day expiration, ","All products within their expiration date including those dated 90 days prior to April 19, 2013 (Jan. 2013 to April 19, 2013). ",".",,"Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes.",4/22/2013,"04/22/2013",6/5/2013,"06/05/2013"
"Drugs",65019,"Ongoing","Nora Apothecary and Alternative Therapies, Inc.","Indianapolis","IN","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Nationwide","D-474-2013","Class II","PHMB Opth Soln 0.02%, 10 ml Opthalmic Soln, 30 day expiration, ","All products within their expiration date including those dated 90 days prior to April 19, 2013 (Jan. 2013 to April 19, 2013). ",".","2","Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes.",4/22/2013,"04/22/2013",6/5/2013,"06/05/2013"
"Drugs",65019,"Ongoing","Nora Apothecary and Alternative Therapies, Inc.","Indianapolis","IN","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Nationwide","D-493-2013","Class II","Lidocaine 2% Inj MDV, 20 ml 30 day expiration, ","All products within their expiration date including those dated 90 days prior to April 19, 2013 (Jan. 2013 to April 19, 2013). ",".",,"Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes.",4/22/2013,"04/22/2013",6/5/2013,"06/05/2013"
"Drugs",65019,"Ongoing","Nora Apothecary and Alternative Therapies, Inc.","Indianapolis","IN","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Nationwide","D-458-2013","Class II","PGE-1 Inj 20mcg/ml MDV: 5ml, 7ml, 10ml, 20ml Penile Injection, 90 day expiration, ","All products within their expiration date including those dated 90 days prior to April 19, 2013 (Jan. 2013 to April 19, 2013). ",".","37","Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes.",4/22/2013,"04/22/2013",6/5/2013,"06/05/2013"
"Drugs",65019,"Ongoing","Nora Apothecary and Alternative Therapies, Inc.","Indianapolis","IN","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Nationwide","D-478-2013","Class II","HCG Inj 1250 un/ml MDV, 4 ml Subcutaneous, 30 day expiration, ","All products within their expiration date including those dated 90 days prior to April 19, 2013 (Jan. 2013 to April 19, 2013). ",".",,"Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes.",4/22/2013,"04/22/2013",6/5/2013,"06/05/2013"
"Drugs",65019,"Ongoing","Nora Apothecary and Alternative Therapies, Inc.","Indianapolis","IN","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Nationwide","D-489-2013","Class II","Renacidin Irrigation: 1000 ml,1120ml Bladder Irrigation, 30 day expiration, ","All products within their expiration date including those dated 90 days prior to April 19, 2013 (Jan. 2013 to April 19, 2013). ",".","2","Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes.",4/22/2013,"04/22/2013",6/5/2013,"06/05/2013"
"Drugs",65019,"Ongoing","Nora Apothecary and Alternative Therapies, Inc.","Indianapolis","IN","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Nationwide","D-494-2013","Class II","Meperidine 100mg/ml MDV, 5ml 90 day expiration, ","All products within their expiration date including those dated 90 days prior to April 19, 2013 (Jan. 2013 to April 19, 2013). ",".",,"Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes.",4/22/2013,"04/22/2013",6/5/2013,"06/05/2013"
"Drugs",65019,"Ongoing","Nora Apothecary and Alternative Therapies, Inc.","Indianapolis","IN","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Nationwide","D-473-2013","Class II","Dexamethasone Opth Soln 0.1% PF, 10 ml Opthalmic Soln, 30 day expiration, ","All products within their expiration date including those dated 90 days prior to April 19, 2013 (Jan. 2013 to April 19, 2013). ",".","7","Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes.",4/22/2013,"04/22/2013",6/5/2013,"06/05/2013"
"Drugs",65019,"Ongoing","Nora Apothecary and Alternative Therapies, Inc.","Indianapolis","IN","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Nationwide","D-484-2013","Class II","Methylcobalamin Inj 5mg/ml MDV: 5 ml, 10 ml, 12 ml, 20 ml Subcutaneous, 90 day expiration, ","All products within their expiration date including those dated 90 days prior to April 19, 2013 (Jan. 2013 to April 19, 2013). ",".","11","Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes.",4/22/2013,"04/22/2013",6/5/2013,"06/05/2013"
"Drugs",65019,"Ongoing","Nora Apothecary and Alternative Therapies, Inc.","Indianapolis","IN","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Nationwide","D-465-2013","Class II","Trimix Inj 4.25ml Form MDV Penile Injection, 90 day expiration, ","All products within their expiration date including those dated 90 days prior to April 19, 2013 (Jan. 2013 to April 19, 2013). ",".",,"Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes.",4/22/2013,"04/22/2013",6/5/2013,"06/05/2013"
"Drugs",65019,"Ongoing","Nora Apothecary and Alternative Therapies, Inc.","Indianapolis","IN","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Nationwide","D-454-2013","Class II","Bimix Inj 30:0.5 MDV, 5 ml syr Penile Injection, 90 day expiration, ","All products within their expiration date including those dated 90 days prior to April 19, 2013 (Jan. 2013 to April 19, 2013). ",".","5","Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes.",4/22/2013,"04/22/2013",6/5/2013,"06/05/2013"
"Drugs",65019,"Ongoing","Nora Apothecary and Alternative Therapies, Inc.","Indianapolis","IN","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Nationwide","D-495-2013","Class II","Pyridoxine 100mg/ml Inj MDV, 1X30 ml 30 day expiration, ","All products within their expiration date including those dated 90 days prior to April 19, 2013 (Jan. 2013 to April 19, 2013). ",".",,"Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes.",4/22/2013,"04/22/2013",6/5/2013,"06/05/2013"
"Drugs",65019,"Ongoing","Nora Apothecary and Alternative Therapies, Inc.","Indianapolis","IN","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Nationwide","D-480-2013","Class II","Hydroxycobalamin Inj 1000mcg/ml MDV: 10 ml, 15 ml, 20 ml, 30 ml Subcutaneous, 90 day expiration, ","All products within their expiration date including those dated 90 days prior to April 19, 2013 (Jan. 2013 to April 19, 2013). ",".","7","Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes.",4/22/2013,"04/22/2013",6/5/2013,"06/05/2013"
"Drugs",65019,"Ongoing","Nora Apothecary and Alternative Therapies, Inc.","Indianapolis","IN","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Nationwide","D-482-2013","Class II","Hydroxycobalamin Inj 2500 mcg/ml MDV, 2x30ml Subcutaneous, 90 day expiration, ","All products within their expiration date including those dated 90 days prior to April 19, 2013 (Jan. 2013 to April 19, 2013). ",".",,"Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes.",4/22/2013,"04/22/2013",6/5/2013,"06/05/2013"
"Drugs",65019,"Ongoing","Nora Apothecary and Alternative Therapies, Inc.","Indianapolis","IN","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Nationwide","D-464-2013","Class II","Trimix Inj 30:3:5 MDV, 10ml Penile Injection, 90 day expiration, ","All products within their expiration date including those dated 90 days prior to April 19, 2013 (Jan. 2013 to April 19, 2013). ",".","1","Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes.",4/22/2013,"04/22/2013",6/5/2013,"06/05/2013"
"Drugs",65019,"Ongoing","Nora Apothecary and Alternative Therapies, Inc.","Indianapolis","IN","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Nationwide","D-481-2013","Class II","Hydroxycobalamin Inj 1 mcg/ml MDV, 2x30ml Subcutaneous, 90 day expiration, ","All products within their expiration date including those dated 90 days prior to April 19, 2013 (Jan. 2013 to April 19, 2013). ",".",,"Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes.",4/22/2013,"04/22/2013",6/5/2013,"06/05/2013"
"Drugs",65019,"Ongoing","Nora Apothecary and Alternative Therapies, Inc.","Indianapolis","IN","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Nationwide","D-476-2013","Class II","HCG Inj 1000un/ml MDV: 4ml, 8 ml Subcutaneous, 30 day expiration, ","All products within their expiration date including those dated 90 days prior to April 19, 2013 (Jan. 2013 to April 19, 2013). ",".","3","Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes.",4/22/2013,"04/22/2013",6/5/2013,"06/05/2013"
"Veterinary",65020,"Ongoing","Nora Apothecary and Alternative Therapies, Inc.","Indianapolis","IN","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","IN, OH, IL, FL, TN","V-190-2013","Class III","Tacrolimus Opth Soln 0.02%,10 ml Opthalmic, 30 day expiration","products within their expiration date that were compounded and dispensed by the pharmacy on or before Friday, April 19, 2013",".","2","The firm announced a voluntary multi-state recall of all sterile drug products compounded by the pharmacy that have not reached the expiration date listed on the product. The compounded products that are subject to the recall are those products within their expiration date that were compounded and dispensed by the pharmacy on or before Friday, April 19, 2013. The recall is being initiated due to concerns associated with quality control processes that present a lack of sterility assurance and were observed during a recent FDA inspection. ",4/22/2013,"04/22/2013",5/29/2013,"05/29/2013"
"Veterinary",65020,"Ongoing","Nora Apothecary and Alternative Therapies, Inc.","Indianapolis","IN","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","IN, OH, IL, FL, TN","V-185-2013","Class III","Cyclosporine Opth Soln 0.2%,10 ml Opthalmic, 30 day expiration","products within their expiration date that were compounded and dispensed by the pharmacy on or before Friday, April 19, 2013",".","5","The firm announced a voluntary multi-state recall of all sterile drug products compounded by the pharmacy that have not reached the expiration date listed on the product. The compounded products that are subject to the recall are those products within their expiration date that were compounded and dispensed by the pharmacy on or before Friday, April 19, 2013. The recall is being initiated due to concerns associated with quality control processes that present a lack of sterility assurance and were observed during a recent FDA inspection. ",4/22/2013,"04/22/2013",5/29/2013,"05/29/2013"
"Veterinary",65020,"Ongoing","Nora Apothecary and Alternative Therapies, Inc.","Indianapolis","IN","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","IN, OH, IL, FL, TN","V-187-2013","Class III","Cyclosporine Opth Soln 2%,10 ml Opthalmic, 30 day expiration","products within their expiration date that were compounded and dispensed by the pharmacy on or before Friday, April 19, 2013",".","2","The firm announced a voluntary multi-state recall of all sterile drug products compounded by the pharmacy that have not reached the expiration date listed on the product. The compounded products that are subject to the recall are those products within their expiration date that were compounded and dispensed by the pharmacy on or before Friday, April 19, 2013. The recall is being initiated due to concerns associated with quality control processes that present a lack of sterility assurance and were observed during a recent FDA inspection. ",4/22/2013,"04/22/2013",5/29/2013,"05/29/2013"
"Veterinary",65020,"Ongoing","Nora Apothecary and Alternative Therapies, Inc.","Indianapolis","IN","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","IN, OH, IL, FL, TN","V-184-2013","Class III","Cyclosporine Opth Oint 0.2%, 6 gm Opthalmic, 30 day expiration","products within their expiration date that were compounded and dispensed by the pharmacy on or before Friday, April 19, 2013",".","2","The firm announced a voluntary multi-state recall of all sterile drug products compounded by the pharmacy that have not reached the expiration date listed on the product. The compounded products that are subject to the recall are those products within their expiration date that were compounded and dispensed by the pharmacy on or before Friday, April 19, 2013. The recall is being initiated due to concerns associated with quality control processes that present a lack of sterility assurance and were observed during a recent FDA inspection. ",4/22/2013,"04/22/2013",5/29/2013,"05/29/2013"
"Veterinary",65020,"Ongoing","Nora Apothecary and Alternative Therapies, Inc.","Indianapolis","IN","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","IN, OH, IL, FL, TN","V-188-2013","Class III","EDTA Opth Soln 1%,10 ml Opthalmic, 30 day expiration","products within their expiration date that were compounded and dispensed by the pharmacy on or before Friday, April 19, 2013",".","1","The firm announced a voluntary multi-state recall of all sterile drug products compounded by the pharmacy that have not reached the expiration date listed on the product. The compounded products that are subject to the recall are those products within their expiration date that were compounded and dispensed by the pharmacy on or before Friday, April 19, 2013. The recall is being initiated due to concerns associated with quality control processes that present a lack of sterility assurance and were observed during a recent FDA inspection. ",4/22/2013,"04/22/2013",5/29/2013,"05/29/2013"
"Veterinary",65020,"Ongoing","Nora Apothecary and Alternative Therapies, Inc.","Indianapolis","IN","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","IN, OH, IL, FL, TN","V-183-2013","Class III","Cyclosporine Opth Oint 0.2%: 3 gm, 6 gm Opthalmic, 30 day expiration","products within their expiration date that were compounded and dispensed by the pharmacy on or before Friday, April 19, 2013",".","3","The firm announced a voluntary multi-state recall of all sterile drug products compounded by the pharmacy that have not reached the expiration date listed on the product. The compounded products that are subject to the recall are those products within their expiration date that were compounded and dispensed by the pharmacy on or before Friday, April 19, 2013. The recall is being initiated due to concerns associated with quality control processes that present a lack of sterility assurance and were observed during a recent FDA inspection. ",4/22/2013,"04/22/2013",5/29/2013,"05/29/2013"
"Veterinary",65020,"Ongoing","Nora Apothecary and Alternative Therapies, Inc.","Indianapolis","IN","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","IN, OH, IL, FL, TN","V-189-2013","Class III","Tacrolimus Opth Soln 0.01%,10 ml Opthalmic, 30 day expiration","products within their expiration date that were compounded and dispensed by the pharmacy on or before Friday, April 19, 2013",".",,"The firm announced a voluntary multi-state recall of all sterile drug products compounded by the pharmacy that have not reached the expiration date listed on the product. The compounded products that are subject to the recall are those products within their expiration date that were compounded and dispensed by the pharmacy on or before Friday, April 19, 2013. The recall is being initiated due to concerns associated with quality control processes that present a lack of sterility assurance and were observed during a recent FDA inspection. ",4/22/2013,"04/22/2013",5/29/2013,"05/29/2013"
"Veterinary",65020,"Ongoing","Nora Apothecary and Alternative Therapies, Inc.","Indianapolis","IN","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","IN, OH, IL, FL, TN","V-191-2013","Class III","Idoxuridine Opth Soln 0.1%,5 ml Opthalmic, 30 day expiration","Products within their expiration date that were compounded and dispensed by the pharmacy on or before Friday, April 19, 2013. ",".","1","The firm announced a voluntary multi-state recall of all sterile drug products compounded by the pharmacy that have not reached the expiration date listed on the product. The compounded products that are subject to the recall are those products within their expiration date that were compounded and dispensed by the pharmacy on or before Friday, April 19, 2013. The recall is being initiated due to concerns associated with quality control processes that present a lack of sterility assurance and were observed during a recent FDA inspection. ",4/22/2013,"04/22/2013",5/29/2013,"05/29/2013"
"Veterinary",65020,"Ongoing","Nora Apothecary and Alternative Therapies, Inc.","Indianapolis","IN","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","IN, OH, IL, FL, TN","V-186-2013","Class III","Cyclosporine Opth Soln 1%,10 ml Opthalmic, 30 day expiration","products within their expiration date that were compounded and dispensed by the pharmacy on or before Friday, April 19, 2013",".","4","The firm announced a voluntary multi-state recall of all sterile drug products compounded by the pharmacy that have not reached the expiration date listed on the product. The compounded products that are subject to the recall are those products within their expiration date that were compounded and dispensed by the pharmacy on or before Friday, April 19, 2013. The recall is being initiated due to concerns associated with quality control processes that present a lack of sterility assurance and were observed during a recent FDA inspection. ",4/22/2013,"04/22/2013",5/29/2013,"05/29/2013"
"Drugs",65021,"Ongoing","Novartis Consumer Health","Lincoln","NE","US","Voluntary: Firm Initiated","Letter","Nationwide","D-420-2013","Class III","Lamisil AT (terbinafine hydrochloride cream 1% antifungal), 24 g (.85 oz) tube, Novartis Consumer Health, Parsippany, NJ 07054, NDC 0067-6171-85","Lot #: 10118124, Exp: Sept 2013",".","3,828 Tubes","Labeling: Incorrect or Missing Lot and/or Expiration date; The Lot and/or Expiration date on the tube may not be legible in this lot.",4/19/2013,"04/19/2013",5/29/2013,"05/29/2013"
"Devices",65022,"Completed","GE Healthcare, LLC","Waukesha","WI","US","Voluntary: Firm Initiated","Visit","Worldwide distribution - USA including AZ, CA, CO, FL, ID, IL, ME, NV,NY, NC, OK, TN, UT, and WI; and Internationally to Canada, Chile, France, Germany, Italy, Japan, Korea, Norway and Spain.","Z-1616-2013","Class II","GE Healthcare, Innova 3100 and Innova 4100 systems. The Digital Fluoroscopic Imaging System is indicated for use in diagnostic and interventional angiographic procedures of human anatomy. It is intended to replace image intensifier fluoroscopic systems in all diagnostic or interventional procedures. ","SERIAL NUMBER 00000007C20103 0000010C2M0069 0000010C2M0181 0000010C2M0214 0000010C2M0259 0000010C2M0137 0000010C2M0159 0000010C2M0262 0000009C2M0084 0000010C2M0130 0000010C2M0218 0000010C2M0297 0000009C2M0108 0000010C2M0236 0000009C2M0167 0000010C2M0208 0000010C2M0295 0000000DUMMY01 00000009C20099 00000007C20141 00000595660BU2 0000010C2M0063 0000010C2M0083 0000009C2M0041 0000010C2M0180 0000010C2M0189 0000010C2M0174 00000593054BU0 00000007C20150 0000010C2M0027 0000010C2M0121 0000010C2M0229 0000010C2M0253 0000010C2M0122 0000010C2M0005 00000007C20173 0000009C2M0040 0000009C2M0077 0000010C2M0088 0000010C2M0097 0000010C2M0143 0000010C2M0192 0000010C2M0193 0000010C2M0204 0000010C2M0294 0000010C2M0269 0000010C2M0176 00000498682BU4 ",".","48","GE Healthcare reported a potential safety issue due to temporary loss of X-Ray Imaging Modes during Collimator Auto-Calibration which affects Innova 3100 and Innova 4100 Systems. ",5/16/2011,"05/16/2011",7/10/2013,"07/10/2013"
"Food",65023,"Ongoing","Early Bird Foods & Co., LLC","Brooklyn","NY","US","Voluntary: Firm Initiated","E-Mail","NY, CT, NJ, MA, TX, OK","F-1381-2013","Class II","Early Bird Foods & Co. CHOC-A-DOODLE-DOO featuring DARK CHOCOLATE & COCONUT granola snack mix, Net Wt. 12 oz packaged in clear plastic bag. Each case contains 12 packages. UPC: 6 89466 30000 0.","BEST ENJOYED BY: OCT 18 2013",,"57 cases (684 units)","Early Bird Foods & Co. LLC is recalling CHOC-A-DOODLE-DOO featuring DARK CHOCOLATE & COCONUT granola snack mix due to Undeclared Soya lecithin.",4/24/2013,"04/24/2013",5/22/2013,"05/22/2013"
"Biologics",65024,"Terminated","Department of Army US Army Blood Bank Center","Fort Hood","TX","US","Voluntary: Firm Initiated","FAX","Afghanistan","B-1899-13","Class II","Red Blood Cells","W012012003060",".","1 unit","Blood product, collected from a donor who traveled to a malarial endemic area, was distributed. ",3/28/2013,"03/28/2013",8/28/2013,"08/28/2013"
"Biologics",65025,"Terminated","Community Blood Centers of South Florida, Inc.","Lake Worth","FL","US","Voluntary: Firm Initiated","FAX","Florida","B-1770-13","Class II","Red Blood Cells","W036810221666; ",".","1","Blood products, collected from a donor whose suitability to donate was not adequately determined, were distributed.",3/6/2013,"03/06/2013",7/24/2013,"07/24/2013"
"Biologics",65025,"Terminated","Community Blood Centers of South Florida, Inc.","Lake Worth","FL","US","Voluntary: Firm Initiated","FAX","Florida","B-1771-13","Class III","Blood and Blood Products for Reprocessing","W036810221666; ",".","1","Blood products, collected from a donor whose suitability to donate was not adequately determined, were distributed.",3/6/2013,"03/06/2013",7/24/2013,"07/24/2013"
"Biologics",65026,"Terminated","Community Blood Centers of South Florida, Inc.","Hialeah","FL","US","Voluntary: Firm Initiated","Letter","Florida","B-1764-13","Class II","Platelets Pooled Leukocytes Reduced","W036812837810; ",,"1","Blood products, collected from a donor whose suitability to donate was not adequately determined, were distributed.",3/11/2013,"03/11/2013",8/7/2013,"08/07/2013"
"Biologics",65026,"Terminated","Community Blood Centers of South Florida, Inc.","Hialeah","FL","US","Voluntary: Firm Initiated","Letter","Florida","B-1768-13","Class II","Platelets","2009327; ",,"1","Blood products, collected from a donor whose suitability to donate was not adequately determined, were distributed.",3/11/2013,"03/11/2013",8/7/2013,"08/07/2013"
"Biologics",65026,"Terminated","Community Blood Centers of South Florida, Inc.","Hialeah","FL","US","Voluntary: Firm Initiated","Letter","Florida","B-1766-13","Class II","Cryoprecipitated AHF","2055025; ",,"1","Blood products, collected from a donor whose suitability to donate was not adequately determined, were distributed.",3/11/2013,"03/11/2013",8/7/2013,"08/07/2013"
"Biologics",65026,"Terminated","Community Blood Centers of South Florida, Inc.","Hialeah","FL","US","Voluntary: Firm Initiated","Letter","Florida","B-1765-13","Class II","Fresh Frozen Plasma (Apheresis)","2452490; ",,"1","Blood products, collected from a donor whose suitability to donate was not adequately determined, were distributed.",3/11/2013,"03/11/2013",8/7/2013,"08/07/2013"
"Biologics",65026,"Terminated","Community Blood Centers of South Florida, Inc.","Hialeah","FL","US","Voluntary: Firm Initiated","Letter","Florida","B-1769-13","Class III","Blood and Blood Products for Reprocessing","W036812491773; W036810005930; 2055025; 2009327; ",,"4","Blood products, collected from a donor whose suitability to donate was not adequately determined, were distributed.",3/11/2013,"03/11/2013",8/7/2013,"08/07/2013"
"Biologics",65026,"Terminated","Community Blood Centers of South Florida, Inc.","Hialeah","FL","US","Voluntary: Firm Initiated","Letter","Florida","B-1767-13","Class II","Red Blood Cells","W036812491773; W036810005930; 2452490; 2055025; 2009327; ",,"5","Blood products, collected from a donor whose suitability to donate was not adequately determined, were distributed.",3/11/2013,"03/11/2013",8/7/2013,"08/07/2013"
"Biologics",65027,"Terminated","AlloSource, Inc.","Centennial","CO","US","Voluntary: Firm Initiated","Letter","Michigan; Alabama; North Carolina","B-1649-13","Class I","Bone","123437106; 123437107; 123437109; 123437110; 123437111; 123437113; 123437114; 123437115; 123437116; 123437117; 123437118; 123437119; 123437126; 123437129; 123437130",".","15 allografts","Human tissue allografts, not processed in a manner that prevents the introduction, transmission, or spread of communicable disease, were distributed.",3/4/2013,"03/04/2013",6/19/2013,"06/19/2013"
"Devices",65029,"Completed","GE Healthcare, LLC","Waukesha","WI","US","Voluntary: Firm Initiated","Visit","Worldwide Distribution -- Nationwide including the states of AL, AZ, AR, CA, CO, CT, DC, FL, GA, GUAM, HI, ID, IL , IN, KS, KY, LA, ME, MD, MA, MI, MN, MS, MO, MT, NE, NV, NH, NH, NM, NY, NC, ND, OH, OK, OR, PA, PR, SC, TN, TX, UT, VT, VA, WA, WY and WI., and the countries of Philippines, Peru, Paraguay, Panama, Mexico, Malaysia, Korea, Japan, Guatemala, Ecuador, Dominican Republic , Columbia, China, Chile, Canada, Brazil.,Argentina and Venezuela","Z-1318-2013","Class II","GE Healthcare Innova 2100 IQ, Innova 3100 IQ, Innova 4100 IQ, Innova 2121 IQ, Innova 3131 IQ , Innova 3100, Innova 4100. For use in generating fluoroscopic images of human anatomy for diagnostic and interventional procedures.","Serial # 00000520055BU5 00000009C20026 00000007C20159 00000007C20161 00000008C2M001 0000009C2M0068 00000007C20152 00000519147BU3 00000466843BU0 00000489559BU5 00000009C20099 00000009C20109 00000466851BU3 00000008C20053 00000519174BU7 00000008C20312 00000008C20210 00000007C20391 00000007C20039 00000007C20322 00000008C20079 00000478341BU1 00000536797BU4 00000009C20075 00000008C20214 00000009C20017 00000498702BU0 00000498705BU3 00000007C20324 00000008C20221 00000465840BU7 00000007C20198 00000007C20183 00000536791BU7 00000008C20224 00000008C20227 00000478340BU3 0000009C2M0119 0000009C2M0127 00000532669BU9 00000007C20117 00000009C20036 00000520074BU6 00000007C20012 00000008C20084 00000007C20219 00000536790BU9 00000489715BU3 00000519096BU2 00000008C20041 00000453944BU1 00000536805BU5 00000008C20004 00000465797BU9 00000520079BU5 00000009C20100 00000008C20030 00000532657BU4 00000008C20094 0000009C2M0084 00000008C20069 00000007C20374 00000009C20072 00000007C20239 00000008C20106 00000532662BU4 00000009C20105 00000536804BU8 00000007C20081 0000009C2M0016 00000007C20131 00000532665BU7 00000008C20170 00000008C20165 00000489556BU1 00000008C20051 00000008C20211 00000520056BU3 00000008C20304 00000008C20300 00000008C20064 00000008C20179 00000498875BU4 00000008C20045 00000007C20352 00000009C20037 00000007C20123 00000008C20323 00000520068BU8 00000498686BU5 00000008C20269 00000564503BU1 00000007C20195 00000519169BU7 00000007C20073 00000008C20213 00000498881BU2 00000009C20056 00000009C20032 00000519162BU2 00000498708BU7 00000007C20141 00000007C20358 00000008C20351 00000009C20043 00000520047BU2 00000477810BU6 00000519154BU9 00000008C20284 0000008C2M0002 00000532664BU0 00000008C20332 00000519132BU5 00000519149BU9 00000007C20091 00000007C20134 00000536785BU9 0000009C2M0033 00000007C20189 00000007C20004 0000009C2M0029 0000009C2M0070 00000519127BU5 00000007C20218 00000007C20370 00000489713BU8 00000556247BU5 00000489771BU6 00000489691BU6 00000489539BU7 00000489767BU4 0000009C2M0135 00000007C20255 00000007C20250 00000007C20078 00000008C20",,"713","While performing a fluoroscopic examination on the GE Innova systems, there is a potential of nonrecoverable loss of imaging modes with no advance warning, due to a relay failure in the power distribution box (PDB). Although no injuries have been reported due to this issue to date, there is risk of complications during the procedure as a result of imaging functionality loss.",12/20/2011,"12/20/2011",5/22/2013,"05/22/2013"
"Food",65030,"Ongoing","Prosperity Resources International, Inc.","Linden","NJ","US","Voluntary: Firm Initiated","Telephone","Retail customers in New York State.","F-1504-2013","Class III","Golden Flower Dried Ginger Net Wt. 6 oz (170g). Packed By: S&Y Co., LTD. No 12 Yuenjiang Road, Gaoming City Guangdong, China. Distributed by: Prosperity Resources Int'l., Inc. USA. Product of China.","UPC 64740601186",".","50 cases (each case contains 50 individual 6 oz. plastic packages)","The Golden Flower Dried Ginger (Net Weight 6 oz. 170 gms) Product of China is in violations to the Agriculture and Markets Law.",3/11/2013,"03/11/2013",6/12/2013,"06/12/2013"
"Devices",65031,"Ongoing","Intel-GE Care Innovations LLC","Roseville","CA","US","Voluntary: Firm Initiated","Telephone","US and Great Britain","Z-1374-2013","Class II","QuietCare-Networked. Intended for use in monitoring the environmental conditions and activity (motion) of an individual living in a senior housing community.","QuietCare-Networked: Facility Server QC101601",".","46","Customers at 4 facilities reported receiving duplicate alerts using the QuietCare-Networked product.",4/4/2013,"04/04/2013",6/5/2013,"06/05/2013"
"Devices",65031,"Ongoing","Intel-GE Care Innovations LLC","Roseville","CA","US","Voluntary: Firm Initiated","Telephone","US and Great Britain","Z-1375-2013","Class II","QuietCare. Intended for use in monitoring the environmental conditions and activity (motion) of an individual living in a senior housing community.","US QuietCare: QC200403, v.02; QC200403, v.03; QC200403, v.04; QC200405 UK QuietCare: QCE200403, v.02; QCE200403, v.03 ",".","1722S; 99 Out of US","Customers at 4 facilities reported receiving duplicate alerts using the QuietCare-Networked product.",4/4/2013,"04/04/2013",6/5/2013,"06/05/2013"
"Food",65032,"Ongoing","Saratoga Therapeutics, LLC","North Wales","PA","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Product was sold through physicians offices and via internet sales to consumers located nationwide and in Canada.","F-1876-2013","Class I","ebA*(TM) Multivitamin Supplement, 180 tablets in plastic bottles, Distributed by Saratoga Therapeutics, LLC, North Wales, PA.","Lot number 0912164, exp 12/12 and 1110354, exp 10/14",".","890 bottles","The recall was initiated due to discovery of the presence of milk components (milk protein(s) and lactose) despite labeling that incorrectly states it is free of milk components. ",2/13/2013,"02/13/2013",9/11/2013,"09/11/2013"
"Devices",65033,"Ongoing","SpineFrontier, Inc.","Beverly","MA","US","Voluntary: Firm Initiated","E-Mail","US distributions to states of: KS and TX.","Z-1870-2013","Class II","S-LIFT Slap Hammer, Part Number: 11-50204, Revision A The slap hammers are used primarily to remove trial instruments that are used to estimate sizes of intervertebral body fusion devices intended to promote fusion. These devices were used in conjunction with lumbar intervertebral body fusion device intended for intervertebral body fusion of the spine of skeletally mature patients. ","Lot: 56H26",,"3","Malfunction of slap hammer. ",4/25/2013,"04/25/2013",8/7/2013,"08/07/2013"
"Devices",65034,"Ongoing","Summit Medical, Inc.","Eagan","MN","US","Voluntary: Firm Initiated","Letter","Distributed in MS, NY, PA and TX.","Z-1319-2013","Class II","Summit Medical, BL-2006, Myringotomy Lance (Juvenile) Blade, Sterile P, Summit Medical, Inc., 815 Northwest Parkway, Suite 100, St. Paul, MN 55121 Use to make an incision in the tympanic membrane.","Lot No. 121012",,"9 boxes","Summit Medical has initiated a recall of Myringotomy Lance Blade (Juvenile) because the box contains the wrong blade. The box contains Myringotomy Spear Blade (Juvenile). ",3/27/2013,"03/27/2013",5/22/2013,"05/22/2013"
"Food",65035,"Ongoing","Conagra Inc","Omaha","NE","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Distribution was made nationwide.","F-1443-2013","Class I","Orville Redenbacher's Classic Kettle Korn, sweet and salty popcorn, ready-to-eat, packaged in 5-oz/plastic bags (Unit UPC code 027000523216) and 1.5-oz/plastic bags (Unit UPC code 027000523254). ","5-oz bags: Batch Code 5486234100, Best by Date SEP 02 2013; Batch Code 5486234200, Best by Date SEP 03 2013; and Batch Code 5486234300, Best by Date SEP 04 2013. 1.5-oz bags: Batch Code 5486234200, Best by Date SEP 03 2013 and Batch Code 5486234300, Best by Date SEP 04 2013.",".","8,666/8/5-oz bag/cases and 5,707/8/1.5-oz bag/cases","The kettle korn flavored ready-to-eat popcorn product may contain ready-to-eat white cheddar flavored popcorn which may pose a hazard to health due to undeclared milk.",4/26/2013,"04/26/2013",5/29/2013,"05/29/2013"
"Devices",65036,"Ongoing","CEFLA DENTAL GROUP","IMOLA, BO",,"IT","Voluntary: Firm Initiated","Letter","US Nationwide Distribution","Z-1217-2013","Class II","MyRay RXDC dental unit x-ray unit ","Model - MyRay RX DC ",".","173 shipped to US","The RX DC dental x-ray unit was found to be noncompliant with 21CFR 1010,2, 1020.30(e) & 1020.30(h). Specifically, 1. The tube housing did not contain a Certification label. 2. The collimator did not contain an identification label. 3. The user's manual did not contain leakage technique factors, tube housing cooling curves and rating charts, and technique factors which lead to operation at maximum line current.",8/10/2012,"08/10/2012",5/29/2013,"05/29/2013"
"Biologics",65037,"Terminated","American National Red Cross (The)","Oakland","CA","US","Voluntary: Firm Initiated","Telephone","California","B-1763-13","Class II","Plasma Frozen within 24 hours (FP24)","084FH15109; ",".","1","Blood product, collected from a donor whose suitability to donate was not adequately determined, was distributed.",4/10/2013,"04/10/2013",7/24/2013,"07/24/2013"
"Biologics",65038,"Terminated","Talecris Plasma Resources Inc","Research Triangle Park","NC","US","Voluntary: Firm Initiated","FAX","North Carolina","B-1762-13","Class III","Source Plasma","3790257469; 3790257180; 3790256644; 3790256260; 3790255828; 3790255494; 3790255100; 3790254863; 3790254530; 3790254270; 3790253472; 3790252922; 3790252673; 3790251933; 3790251841; 3790251087; 3790250939; 3790250281; 3790250177; 3790249386; 3790249125; 3790248527; 3790248244; 3790247722; 3790247421; 3790246602; 37902246113; 3790245714; 3790245113; 3790244885; 3790244154; 3790244048; 3790243116; 3790242788; 3790242245; 3790241926; 3790241428; 3790241095; 3790240608; 3790240359; 3790239984; 3790239546; 3790239042; 3790238716; 3790238168; 3790237858; 3790237272; 3790236967; 3790236464; 3790236130; 3790235562; 3790235177; 3790234608; 3790234316; 3790233728; 3790233443; 3790232961; 3790232696; 3790231965; 3790231667; 3790231096; 3790230808; 3790230300; 3790229982; 3790229441; 3790229192; 3790228604; 3790228279; 3790227732; 3790227402; 3790261668; 3790261235; 3790261038; 3790260537; 3790260346; 3790259386; 3790259110; 3790258319; 3790258054; ",".","79","Blood product, collected from a donor whose suitability to donate was not adequately determined, was distributed.",3/20/2013,"03/20/2013",7/24/2013,"07/24/2013"
"Biologics",65039,"Terminated","American National Red Cross (The)","Madison","WI","US","Voluntary: Firm Initiated","FAX","Wisconsin","B-1991-13","Class III","Platelets Pheresis Leukocytes Reduced Washed","032LM04000; ",,"1","Blood product, with a volume significantly higher than the usual and expected amount, was distributed.",3/11/2013,"03/11/2013",8/7/2013,"08/07/2013"
"Food",65041,"Ongoing","Krinos Foods, Inc.","Long Island City","NY","US","Voluntary: Firm Initiated","Telephone","CA, CO, CT, FL, GA, IA, IL, IN, MA, MD, MI, NC, NH, NJ, NY, OH, OR, PA, RI, SC, TX, VA, VI and WI","F-1441-2013","Class I","Krinos TAHINI ground sesame seeds, 1) Net. Wt. 1 lb (454g) in glass jars with gold lids packed 12 jars per case - UPC Code 0-75013-28500-3, 2) Net. Wt. 2 lb in glass jars with gold lids packed 12 jars per case - UPC Code 0-75013-28510-2 and 3) Net. Wt. 40 lb (18 kg) in plastic tub packed 1 tub per case-UPC Code 0-75013-04018-3.","EXP JAN 01 2014 up to and including EXP JUN 08 2014 and EXP OCT 16 2014 up to and including EXP MAR 15 2015.",".","3, 667 cartons (3,501 ctns of 1 pound, 108 ctns of 2 pound and 58 ctns of 40 pound)","Salmonella contamination.",4/26/2013,"04/26/2013",5/29/2013,"05/29/2013"
"Devices",65042,"Ongoing","Zimmer, Inc.","Warsaw","IN","US","Voluntary: Firm Initiated","E-Mail","Nationwide Distribution.","Z-1376-2013","Class II","NEXGEN Complete Knee Solution Monoblock Tibial Drill with stop 10.7 mm. Used to prepare cylindrical holes in the native tibia.","Part No. 00-5887-052-00; lots 62181290 and 62183430",".","69 units","Zimmer is initiating a lot specific recall of the Trabecular Metal'' Tibia Stop Drill due to the potential of the outside diameter being oversized. As a result, there is a potential for the drill to not pass through the applicable drill guide.",3/27/2013,"03/27/2013",6/5/2013,"06/05/2013"
"Devices",65043,"Ongoing","Ebi, Llc","Parsippany","NJ","US","Voluntary: Firm Initiated","Letter","Nationwide distribution: US including states of: CA, GA, IN, KY, MO, NY, OR, TX, and WI.","Z-2292-2013","Class II","Solitaire-35 Peek Solitaire Anterior Spinal System. The Solitaire-35 is an intervertebral body fusion device. ","14-535140 12 mm 6-deg narrow 2327561 October-22 2302271 April-22 14-535141 14mm 6-deg narrow 2327661 November-22 2302281 April-22 14-535142 16mm 6-deg narrow 2327691 December-22 2302291 April-22 14-535143 18 mm 6-deg narrow 2327701 December-22 2302301 April-22 14-535144 20mm 6-deg narrow 2327711 December-22 2302301 April-22 14-535144 20 mm 6-deg narrow 2302311 June-22 14-535150 12mm 12-deg narrow 2327711 December-22 2302321 April-22 14-535151 14mm 12-deg narrow 2327601 October-22 2302332 April-22 14-535152 16mm12-deg narrow 2327671 November-22 2302341 April-22 14-535153 18 mm 12-deg narrow 2327751 December-22 2302351 April-22 14-535154 20 mm 12-deg narrow 2327571 December-22 2327571 November-22 2302361 April-22 14-535170 12mm 6-deg medium 2327631 October-22 2302371 April-22 14-5351711 14 mm 6-deg medium 2327641 October-22 2302381 April-22 14-535172 16 mm 6-deg medium 2327761 December-22 2302391 April-22 14-535173 18 mm 6-deg medium 2327771 Dec 22 2302401 April 22 14-535174 20 mm 6-deg medium 2302411 April-22 14-535180 12mm 12-deg medium 2327621 October-22 2302421 April-22 14-535180 12 mm 12-deg medium 2327621 October-22 2302421 April-22 14-535182 16mm 12-deg medium 2327651 October 22 2302441 April 22 14-535183 18 mm 12-deg medium 2302451 April-22 14-535184 20 mm 12-deg medium 2327581 October-22 2302461 April-22 14-535200 12 mm 6-deg wide 2302471 April-22 14-535201 14mm 6-deg wide 2327721 December-22 2302481 April-22 14-535202 16 mm 6-deg wide 2327591 October-22 2302491 March-22 14-535203 18 mm 6-deg wide 2328311 October-22 2302501 April-12 14-535204 20 mm 6-deg wide 2302511 April-22 14-535210 12 mm 12 deg wide 2302521 April 22 14-535211 14 mm 12-deg wide 2327681 Decembr-22 2302531 April-22 14-535212 16 mm 12-deg wide 2327731 December-22 2302541 April-22 14-535213 18mm 12-deg wide 2327741 Decembe",,"1730 units","Several complaints were recorded regarding one of the three screws driving through the cage of the Solitaire 35 implant.",4/9/2013,"04/09/2013",10/9/2013,"10/09/2013"
"Biologics",65044,"Ongoing","Fenwal Inc","Lake Zurich","IL","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","US (CA, OR, OH, MI)","B-1669-13","Class III","Anticoagulant Citrate Phosphate Dextrose Solution, USP (CPD) Blood Pack Unit, NDC#0942-6470-03, Rx, 4R1584 ","FM13A15027",".","16,740 units","BLOOD-PACK Units in which the platelet container is incorrectly labeled as ''AS-1 Red Blood Cell Adenine-Saline added'', were distributed. ",4/24/2013,"04/24/2013",6/19/2013,"06/19/2013"
"Food",65045,"Ongoing","Grippo Potato Chip Co., Inc.","Cincinnati","OH","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Product was distributed to the following states: IL, IN, KY, OH, TN & VA.","F-1399-2013","Class II","Grippo's BAR-B-Q FLAVORED POTATO CHIPS, 1oz, 1 1/8oz, 1oz, 3.5oz, 8oz, 12oz bags & 1.5lb boxes, INGREDIENTS: SELECTED POTATOES, VEGETABLE OIL***AND SALT, SUGAR, TORULA YEAST, SPICES, MONOSODIUM GLUTAMATE, CORN FLOUR ONION POWDER, GARLIC POWDER, NATURAL HICKORY SMOKE FLAVOR, CARMEL COLOR, PAPRIKA EXTRACT, SILICON DIOXIDE. CONTAINS: SULFITES. www.grippopotatochips.com GRIPPO POTATO CHIP CO, INC. CINCINNATI, OH 45239 UPC: 0 76847 13131 3 Product Quantity Distributed: 19,685cs/60/1oz bags; 19,755cs/48/1 1/8oz bags; 56,217cs/24/1oz bags; 61,413cs/18/3.5oz bags; 88,940cs/6/Twin Pks; 59,790cs/9/8oz bags; 42,204cs/6/12oz bags; 73,685cs/36/1oz bags & 152,845/1.5# boxes.","All bagged products with an expiration date of May 20th and prior, all 1.5# boxes with an expiration date of April 29 and prior.",,"See product description.","During an inspection by the Ohio Department of Agriculture, the firm was notified of numerous metal fragments in the salt hopper.",3/15/2013,"03/15/2013",5/22/2013,"05/22/2013"
"Food",65045,"Ongoing","Grippo Potato Chip Co., Inc.","Cincinnati","OH","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Product was distributed to the following states: IL, IN, KY, OH, TN & VA.","F-1398-2013","Class II","Grippo's Potato Chips, 1oz, 1 1/8oz , 1oz, 3.5oz, 8oz, 12oz bags & 1.5lb boxes, INGREDIENTS: SELECTED POTATOES, VEGETABLE OIL***AND SALT. www.grippopotatochips.com GRIPPO POTATO CHIP CO, INC. CINCINNATI, OH 45239 UPC: 0 76847 61701 5 Product Quantity Distributed: 1,410cs/60/1oz bags; 860cs/48/1 1/8oz bags; 5,802cs/24/1oz bags; 2,517cs/18/3.5oz bags; 11,701cs/6/Twin Pks; 2,009cs/9/8oz bags; 234cs/6/12oz bags; 71cs/36/1oz bags & 21,970/1.5# boxes.","All bagged products with an expiration date of May 20th and prior, all 1.5# boxes with an expiration date of April 29 and prior.",,"See Product Description","During an inspection by the Ohio Department of Agriculture, the firm was notified of numerous metal fragments in the salt hopper.",3/15/2013,"03/15/2013",5/22/2013,"05/22/2013"
"Food",65045,"Ongoing","Grippo Potato Chip Co., Inc.","Cincinnati","OH","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Product was distributed to the following states: IL, IN, KY, OH, TN & VA.","F1402-2013","Class II","Grippo's HOT DILL PICKLE Artificially Flavored Potato Chips, 1oz, 3.5oz, INGREDIENTS: SELECTED POTATOES, VEGETABLE OIL***AND SALT, WHEY, MALTODEXTRIN, MODIFIED CORN STARCH, SUGAR, MONOSODIUM GLUTAMATE, SODIUM DIACETATE, SPICES, ONION, GARLIC VINEGAR SOLIDS, NATURAL AND ARTIFICIAL FLAVOR, AND NOT MORE THAN 2% SILICON DIOXIDE ADDED www.grippopotatochips.com GRIPPO POTATO CHIP CO, INC. CINCINNATI, OH 45239 UPC: 0 7684714126 8","All bagged products with an expiration date of May 20th and prior.",,"632cs/24/1oz bags & 436cs/18/3.5oz bags.","During an inspection by the Ohio Department of Agriculture, the firm was notified of numerous metal fragments in the salt hopper.",3/15/2013,"03/15/2013",5/22/2013,"05/22/2013"
"Food",65045,"Ongoing","Grippo Potato Chip Co., Inc.","Cincinnati","OH","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Product was distributed to the following states: IL, IN, KY, OH, TN & VA.","F-1400-2013","Class II","Grippo's Sweet BERMUDA ONION FLAVORED POTATO CHIPS, 1oz, 1oz, 3.5oz, INGREDIENTS: SELECTED POTATOES, VEGETABLE OIL***AND SALT, SWEET BERMUDA ONION SEASONING***www.grippopotatochips.com GRIPPO POTATO CHIP CO, INC. CINCINNATI, OH 45239 UPC: 0 76847 61703 9","All bagged products with an expiration date of May 20th and prior.",,"556cs/60/1oz bags; 995cs/24/1oz bags & 1244cs/18/3.5oz bags.","During an inspection by the Ohio Department of Agriculture, the firm was notified of numerous metal fragments in the salt hopper.",3/15/2013,"03/15/2013",5/22/2013,"05/22/2013"
"Food",65045,"Ongoing","Grippo Potato Chip Co., Inc.","Cincinnati","OH","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Product was distributed to the following states: IL, IN, KY, OH, TN & VA.","F-1401-2013","Class II","Grippo's Salt & Vinegar FLAVORED POTATO CHIPS, 1oz, 3.5oz, INGREDIENTS: SELECTED POTATOES, VEGETABLE OIL***AND SALT, LACTOSE, SALT, DEXTROSE, SODIUM DIACETATE, MALIC ACID, AND NOT MORE THAN 2% SILICON DIOXIDE ADDED CONTAINS: MILK***www.grippopotatochips.com GRIPPO POTATO CHIP CO, INC. CINCINNATI, OH 45239 UPC: 0 76847 14125 1","All bagged products with an expiration date of May 20th and prior.",,"1,909cs/24/1oz bags & 2,619cs/18/3.5oz bags.","During an inspection by the Ohio Department of Agriculture, the firm was notified of numerous metal fragments in the salt hopper.",3/15/2013,"03/15/2013",5/22/2013,"05/22/2013"
"Food",65045,"Ongoing","Grippo Potato Chip Co., Inc.","Cincinnati","OH","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Product was distributed to the following states: IL, IN, KY, OH, TN & VA.","F-1403-2013","Class II","Grippo's CHEDDAR CHEESE WITH A TOUCH OF JALAPENO natural & Artificially Flavored POTATO CHIPS, 1oz, 3.5oz, INGREDIENTS: SELECTED POTATOES, VEGETABLE OIL***AND SALT, GRANULAR CHEESE (MILK, CHEESE CULTURES, SALT ENZYMES), MONOSODIUM GLUTAMATE, PARTIALLY HYDROGENATED SOYBEAN AND COTTONSEED OIL, SPICES, SUGAR, DEXTROSE, WHEY PROTEIN CONCENTRATE, LACTOSE MALTODEXTRIN, CITRIC ACID, BLUE CHEESE (MILK, CHEESE CULTURES, SALT, ENZYMES), SODIUM PHOSPHATE, CORN STARCH, YEAST EXTRACT, ONION, GARLIC, MODIFIED CORN STARCH, JALAPENO PEPPER, NATURAL AND ARTIFICIAL FLAVOR (CONTAINS MILK) ARTIFICIAL COLORS***LACTIC ACID AND NOT MORE THAN 2% SILICON DIOXIDE ADDED www.grippopotatochips.com GRIPPO POTATO CHIP CO, INC. CINCINNATI, OH 45239 UPC: 0 76847 14127 5","All bagged products with an expiration date of May 20th and prior.",,"495cs/24/1oz bags & 475cs/18/3.5oz bags.","During an inspection by the Ohio Department of Agriculture, the firm was notified of numerous metal fragments in the salt hopper.",3/15/2013,"03/15/2013",5/22/2013,"05/22/2013"
"Devices",65046,"Ongoing","Bard Peripheral Vascular Inc","Tempe","AZ","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Worldwide Distribution: USA Nationwide and Internationally to Europe.","Z-1524-2013","Class II","BARD Biopsy Systems UltraClip Dual Trigger breast tissue marker. Intended for use to attach to soft breast tissue at the surgical site during an open surgical breast biopsy. ","Affected Product Lots with the following Product Code and Lot Number combinations. Product Code 864017D 864017D 864017D 864017D 864017D 864017D 864017D 864017DL Lot Number HUWI1522 HUWI1941 HUWI1942 HUWI1943 HUWJ1851 HUWJ1852 HUWK0350 HUWJ1610 ",".","3,085","Bard Peripheral Vascular (BPV) has confirmed that some devices with the recalled product code / lot number combination may have the metal tissue marker separated from the needle prior to use.",4/16/2013,"04/16/2013",6/19/2013,"06/19/2013"
"Drugs",65047,"Ongoing","Hi-Tech Pharmacal Co., Inc.","Amityville","NY","US","Voluntary: Firm Initiated","Letter","Nationwide and Puerto Rico","D-603-2013","Class III","HydrOXYzine Hydrochloride Oral Solution, USP, 10 mg/5 mL, 16 fl. oz. (473 mL), Rx Only, HI-TECH PHARMACAL CO., INC. AMITYVILLE, NY, NDC 50383-796-16","Batch 608917 (exp. 02/2014), and Batch 608204 (exp. 01/2014)",,"lot 608917: 7764 bottles; lot 608204: 7476 bottles","Subpotent; 24 month stability test station",4/30/2013,"04/30/2013",6/26/2013,"06/26/2013"
"Devices",65048,"Ongoing","Alere San Diego, Inc.","San Diego","CA","US","Voluntary: Firm Initiated","Letter","United States Nationwide Distribution","Z-1401-2013","Class II","Alere'' hCG Combo Cassette (20/10 mIU/mL) Kit. Product Usage: The AlereTM hCG Combo (20/10 mIU/mL) test is a rapid chromatographic immunoassay for the qualitative detection of human chorionic gonadotropin (hCG) in serum or urine, as an aid in the early detection of pregnancy. It is for healthcare professionals only.","Lot/Unit Codes: hCG1110133 & hCG1110135 Part Number: 92215 Expiration date, or Expected shelf life: 9/30/13 & 10/31/13",".","3975 kits","The firm initiated recall of Alere'' hCG Combo Cassette (20/10 mIU/mL) kit PN 92215, lots hCG1110133 and hCG1110135, because an investigation has indicated a portion of these Alere'' hCG Combo Cassette (20/10 mIU/mL) PN 92215 kit lots were incorrectly packaged with the Alere'' hCG Cassette (20 mIU/mL) PN 92210 Product Insert. The Alere'' hCG Cassette (20 mIU/mL) Product Insert contains information for hCG urine testing but lacks information for performing the hCG serum testing using the Alere'' hCG Combo Cassette product. ",4/16/2013,"04/16/2013",6/5/2013,"06/05/2013"
"Devices",65049,"Ongoing","Toshiba American Medical Systems Inc","Tustin","CA","US","Voluntary: Firm Initiated","Letter","US Nationwide Distribution","Z-1598-2013","Class II","TOSHIBA Kalare Diagnostic X-Ray System K110785","DREX-KL80 NO. SERIAL# LAST FOUR . MANUFACTURE DATE 1 99C1042292 2292 APRIL 2010 2 99C1162353 2353 JUNE 2011 3 99C1062307 2307 JUNE 2010 4 99C1072311 2311 JULY 2010 5 99C0972246 2246 JULY 2009 6 99C09Z2273 2273 DECEMBER 2009 7 99C1212372 2372 JANUARY 2012 8 99C0932234 2234 MARCH 2009 9 99C09X2262 2262 OCTOBER 2009 10 99C1182359 2359 AUGUST 2011 11 99C1022285 2285 FEBRUARY 2010 12 99C10Y2329 2329 NOVEMBER 2010 13 99C1092316 2316 SEPTEMBER 2010 14 99C1262385 2385 JUNE 2012 15 99C09Y2265 2265 NOVEMBER 2009 16 99C1122344 2344 FEBRUARY 2011 17 99C0982248 2248 AUGUST 2009 18 99C09Z2276 2276 DECEMBER 2009 19 99C1282389 2389 AUGUST 2012 20 99C1072309 2309 JULY 2010 21 99C0912228 2228 JANUARY 2009 22 99C1062303 2303 JUNE 2010 23 99C1212374 2374 JANUARY 2012 24 99C11Y2369 2369 NOVEMBER 2011 25 99C09X2260 2260 OCTOBER 2009 26 99C1042297 2297 APRIL2010 27 Jll1293530 3530 SEPTEMBER 2012 28 99C1012278 2278 JANUARY 2010 29 99C10Y2328 2328 NOVEMBER 2010 30 99C1052299 2299 MAY 2010 31 99C0982250 2250 AUGUST 2008 32 99C1242381 2381 APRIL 2012 33 J1H08Z3448 3448 DECEMBER 2008 34 99C1252383 2383 MAY 2012 35 99C1022287 2287 FEBRUARY 2010 36 99C1072308 2308 JULY 2010 37 99C1042291 2291 APRIL2010 38 99C1042290 2290 APRIL2010 39 99C09X2258 2258 OCTOBER 2009 40 99B0892210 2210 SEPTEMBER 2008 41 99C1162355 2355 JUNE 2011 42 99C11X2364 2364 OCTOBER 2011 43 99C1162352 2352 JUNE 2011 44 99B08Y2216 2216 NOVEMBER 2008 45 99C11X2367 2367 OCTOBER 2011 46 99C12Y2396 2396 NOVEMBER 2012 47 99C1162354 2354 JUNE 2011 48 99C1012282 2282 JANUARY 2010 49 99C1042294 2294 APRIL 2010 50 99C0912227 2227 JANUARY 2009 51 99C12X2393 2393 OCTOBER 2012 52 99C0982251 2251 AUGUST2009 53 99C1182358 2358 AUGUST2011 54 99B08X2213 2213 OCTOBER 2008 55 99C1012279 2279 JANUARY 2010 NO. SERIAL# LAST FOUR MANUFACTURE DATE 56 99C1062305 2305 JUNE 2010 57 99D0962239 2239 JUNE 2009 58 99C0922230 2230 FEBRUARY 2009 59 99C0992255 2255 SEPTEMBER 2009 60 99C09Z2271 2271 DECEMBER 2009 61 99C1092317 2317 SEPTEMBER 2010 62 99C1212371 2371 JANUARY 2012 63 99C1052302 2302 MAY2010 6",".","153 units","Firm initiated recall because when radiographic conditions with the small focus are set and the radiography ready switch is held down, the large focus is also heated after a few seconds or more. This occurs when the Automatic Exposure Function (AEC) function is used. As a result, a radiographic tube current exceeding the set value flows and a brighter image than expected is acquired.",4/3/2013,"04/03/2013",7/17/2013,"07/17/2013"
"Drugs",65050,"Ongoing","Teva Pharmaceuticals USA, Inc.","Sellersville","PA","US","Voluntary: Firm Initiated","Letter","Nationwide","D-598-2013","Class III","Amoxicillin for Oral Suspension, USP 400mg/5mL, NDC 0093-4161-78 (75ml) and 0093-4161-73 (100mL)","a) NDC 0093-4161-78 -- lot numbers 35426081A, 35426082A, 35426083A, 35426084A, Exp: 06/2014; 35426648A, Exp 08/2014; 35427222A, 35427224A, 35427226A, 35427223A, 35427227A, 35427228A, Exp 10/2014; and b) NDC 0093-4161-73 -- lot numbers 35426631A, 35426632A, 35426633A, 35426634A, 35426635A, 35426636A, 35426637A, 35426638A, 35426639A, 35426640A, 35426680B, 35426681B, 35426682B, Exp 08/2014; 35426641A, 35426642A, Exp 09/2014.",".","758,554 bottles","Discoloration: This recall is being carried out due to a yellow to brown discolored Amoxicillin powder on the inner foil seal of the bottles.",4/26/2013,"04/26/2013",6/19/2013,"06/19/2013"
"Devices",65051,"Ongoing","Siemens Healthcare Diagnostics, Inc.","Newark","DE","US","Voluntary: Firm Initiated","Letter","Nationwide Distribution including AK, AL, AR, AZ, CA, DC, FL, GA, IA, IL, LA, MD, MI, MO, MS, NC, NH, NJ, NM, OH, OR, PA, PR, SC, SD, TN, TX, UT, VA, WA, and WI.","Z-0517-2014","Class II","Dimension(R) TACR Flex(R) reagent cartridge (DF107) The TACR method is an in vitro diagnostic test intended to quantitatively measure Tacrolimus in human whole blood on the Dimension(R) clinical chemistry system. Measurements of Tacrolimus are used as an aid in the management of Tacrolimus therapy in kidney and liver transplant patients","Siemens Material Number 10444938, lot numbers GB3099, GA3120, DB3141, GB3162, GB3176, FA3197, FA3267 and FB3267.",".","13,751","Siemens has confirmed that the TACR method may demonstrate reduced on-board stability which may result in imprecise and inaccurate QC and patient results.",4/25/2013,"04/25/2013",12/26/2013,"12/26/2013"
"Biologics",65052,"Terminated","Memorial Blood Centers","Saint Paul","MN","US","Voluntary: Firm Initiated","FAX","Minnesota","B-1761-13","Class II","Platelets Pheresis Leukocytes Reduced Irradiated","W051513048004; ",".","1","Blood product, labeled leukoreduced which did not meet the requirements for a leukoreduced product, was distributed. ",4/10/2013,"04/10/2013",7/24/2013,"07/24/2013"
"Biologics",65053,"Terminated","Central Blood Bank","Pittsburgh","PA","US","Voluntary: Firm Initiated","Telephone","Pennsylvania","B-1760-13","Class II","Red Blood Cells (Apheresis)","W084713000100; W084713000100; ",".","2","Blood products, which did not undergo the required quality control testing, were distributed.",2/19/2013,"02/19/2013",7/24/2013,"07/24/2013"
"Biologics",65054,"Terminated","Central Blood Bank","Pittsburgh","PA","US","Voluntary: Firm Initiated","Telephone","Pennsylvania","B-1759-13","Class II","Red Blood Cells (Apheresis)","W085912007051; W086112001014; ",".","2","Blood products, quarantined pending discard, were distributed",2/6/2013,"02/06/2013",7/24/2013,"07/24/2013"
"Biologics",65055,"Terminated","HCSC-Blood Center","Bethlehem","PA","US","Voluntary: Firm Initiated","FAX","Pennsylvania; Korea,","B-1814-13","Class II","Red Blood Cells (Apheresis)","W050912005453; ",,"1","Blood products, collected from donors for whom donor suitability was not adequately determined, were distributed.",1/4/2013,"01/04/2013",7/31/2013,"07/31/2013"
"Biologics",65055,"Terminated","HCSC-Blood Center","Bethlehem","PA","US","Voluntary: Firm Initiated","FAX","Pennsylvania; Korea,","B-1815-13","Class II","Fresh Frozen Plasma (Apheresis)","W050912005453; ",,"1","Blood products, collected from donors for whom donor suitability was not adequately determined, were distributed.",1/4/2013,"01/04/2013",7/31/2013,"07/31/2013"
"Biologics",65055,"Terminated","HCSC-Blood Center","Bethlehem","PA","US","Voluntary: Firm Initiated","FAX","Pennsylvania; Korea,","B-1816-13","Class II","Red Blood Cells Irradiated","W050912008713; ",,"1","Blood products, collected from donors for whom donor suitability was not adequately determined, were distributed.",1/4/2013,"01/04/2013",7/31/2013,"07/31/2013"
"Biologics",65055,"Terminated","HCSC-Blood Center","Bethlehem","PA","US","Voluntary: Firm Initiated","FAX","Pennsylvania; Korea,","B-1817-13","Class II","Red Blood Cells"," W050912002027; W050912009851; ",,"2 units","Blood products, collected from donors for whom donor suitability was not adequately determined, were distributed.",1/4/2013,"01/04/2013",7/31/2013,"07/31/2013"
"Biologics",65055,"Terminated","HCSC-Blood Center","Bethlehem","PA","US","Voluntary: Firm Initiated","FAX","Pennsylvania; Korea,","B-1818-13","Class II","Red Blood Cells Leukocytes Reduced","W050912009111; W050912000741; ",,"2","Blood products, collected from donors for whom donor suitability was not adequately determined, were distributed.",1/4/2013,"01/04/2013",7/31/2013,"07/31/2013"
"Biologics",65055,"Terminated","HCSC-Blood Center","Bethlehem","PA","US","Voluntary: Firm Initiated","FAX","Pennsylvania; Korea,","B-1819-13","Class III","Blood and Blood Products for Reprocessing","W050912009111; W050912002027; W05091009851; W050912000741; ",,"4","Blood products, collected from donors for whom donor suitability was not adequately determined, were distributed.",1/4/2013,"01/04/2013",7/31/2013,"07/31/2013"
"Food",65056,"Ongoing","Maple View Ice Cream","Hillsborough","NC","US","Voluntary: Firm Initiated","Telephone","NC","F-1379-2013","Class II","Maple View Farm Ice Cream, Cookie Dough, One Fluid Pint (473ml), Maple View Farm Ice Cream Co., LLC, Hillsborough, NC 27278.","Individual containers are not coded. Product distributed from Sept. 5, 2012 and April 24, 2013.",".",,"Undeclared allergens: Wheat and Soy (soy lecithin).",4/25/2013,"04/25/2013",5/15/2013,"05/15/2013"
"Food",65056,"Ongoing","Maple View Ice Cream","Hillsborough","NC","US","Voluntary: Firm Initiated","Telephone","NC","F-1377-2013","Class I","Maple View Farm Ice Cream, Carolina Crunch, One Fluid Pint (473ml), Maple View Farm Ice Cream Co., LLC, Hillsborough, NC 27278.","Individual containers are not coded. Product distributed from Sept. 5, 2012 and April 24, 2013.",".","2,650 pints","Undeclared allergens: Peanuts, Almond and Soy (soy lecithin and soybean oil).",4/25/2013,"04/25/2013",5/15/2013,"05/15/2013"
"Food",65056,"Ongoing","Maple View Ice Cream","Hillsborough","NC","US","Voluntary: Firm Initiated","Telephone","NC","F-1378-2013","Class II","Maple View Farm Ice Cream, Cookies and Cream, One Fluid Pint (473ml), Maple View Farm Ice Cream Co., LLC, Hillsborough, NC 27278.","Individual containers are not coded. Product distributed from Sept. 5, 2012 and April 24, 2013.",".",,"Undeclared allergens: Wheat and Soy (soybean oil).",4/25/2013,"04/25/2013",5/15/2013,"05/15/2013"
"Food",65057,"Ongoing","Green Mountain Coffee Roasters","Waterbury","VT","US","Voluntary: Firm Initiated","Letter","TX, LA, MD, IN, IL, NE, NC, MN, WI, FL, AL","F-1584-2013","Class II","Master Cases, Product Code #8534 (6-12 count retail boxes) Label of master case bears the name: Donut House K -Cup Packs. 12-Count Retail Boxes, Product Code #8934, Donut House Decaffeinated K-Cup Packs","Best By: 15NOV2013 PL113 3049",".","288,144 kcups/4,002 master cases (6 retail boxes per case)/ 24,012 retail boxes","Regular (caffeinated) Coffee individual K-cup packs were packaged inside multi unit retail boxes labeled Decaffeinated Coffee. ",5/3/2013,"05/03/2013",7/10/2013,"07/10/2013"
"Food",65057,"Ongoing","Green Mountain Coffee Roasters","Waterbury","VT","US","Voluntary: Firm Initiated","Letter","TX, LA, MD, IN, IL, NE, NC, MN, WI, FL, AL","F-1584-2013","Class II","Master Cases, Product Code #8534 (6-12 count retail boxes) Label of master case bears the name: Donut House K -Cup Packs. 12-Count Retail Boxes, Product Code #8934, Donut House Decaffeinated K-Cup Packs","Best By: 15NOV2013 PL113 3049",,"288,144 kcups/4,002 master cases (6 retail boxes per case)/ 24,012 retail boxes","Regular (caffeinated) Coffee individual K-cup packs were packaged inside multi unit retail boxes labeled Decaffeinated Coffee. ",5/3/2013,"05/03/2013",7/31/2013,"07/31/2013"
"Food",65059,"Ongoing","Pure Herbs Ltd","Sterling Heights","MI","US","Voluntary: Firm Initiated","Letter","The Pure Herbs products are sold to a network of independent distributors/consumers.","F-1505-2013","Class I","Pure Herbs, Ltd. Natural Herbal Extracts Protein Dietary Supplement.120mL/4 fl. oz. bottle; 30mL/1 fl.oz bottle.","Lot codes being recalled are lots 243 and 050812, 012712A.. All Protein products manufactured prior to lot 243 are being recalled. Unfortunately the firm does not have records to indicate the lot numbers prior to lot 243. ",".","813 x 4oz bottles and 72 x 1oz bottles ","Pure Herbs, Ltd. Protein Extract contains undeclared milk and soy allergens. People who have an allergy or severe sensitivity to milk or soy run the risk of serious or life-threatening allergic reaction if they consume this product. ",5/4/2013,"05/04/2013",6/19/2013,"06/19/2013"
"Devices",65060,"Ongoing","Elekta, Inc.","Atlanta","GA","US","Voluntary: Firm Initiated","Letter","USA Nationwide including the states of CA, FL, IL, MD, MA, NJ, NY, NC, ND, OH, OR, PA, TN, TX, VA, WA, DC and Puerto Rico","Z-1402-2013","Class II","Integrity 3.0 Product Usage: The Agility multileaf collimator is indicated for use when additional flexibility is required in conforming the radiation beam to the anatomy to be exposed. ","325134, 325254, 325082, 325159, 325268, 325237, 325331, 325267, 325236, 325314, 325127, 325261, 325286, 325077, 325269, 325129, 325296, 325273, 325139, 325201, 325137, 325184, 325161, 325076, 325086, 325112, 325081, 325083, 325099, 325110, 325271",".","31","Unexpected movement during beam delivery may not be detected if there are incorrect static tolerances for Linac Geometric Axes loaded in Integrity R3.0. ",4/30/2013,"04/30/2013",6/5/2013,"06/05/2013"
"Drugs",65061,"Ongoing","Baxter Healthcare Corp.","Deerfield","IL","US","Voluntary: Firm Initiated","Letter","Nationwide and Singapore","D-623-2013","Class II","0.9% Sodium Chloride Injection, USP, 50 mL Mini-Bag Plus Container, Rx only, distributed by Baxter Healthcare Corporation, Deerfield, IL 60015, USA, NDC 0338-0553-11"," Lot: P293118; Exp Date: 10/13 ",,"317,280 bags","Labeling Wrong Barcode; It may display wrong product code reflecting 0.9% Sodium Chloride Injection , USP 100 mL in MINI-BAG Plus container instead of 50 mL.",2/27/2013,"02/27/2013",7/3/2013,"07/03/2013"
"Devices",65062,"Ongoing","Berchtold Corp.","N Charleston","SC","US","Voluntary: Firm Initiated","Letter","Nationwide Distribution","Z-1488-2013","Class II","Hand Controls for Operon D750, D752, D760, D820 and D850 The hand controls are used to operate OPERON surgical tables","The hand controls are neither serialized nor lot coded.",".","3763","The firm received complaints for unintended movements.",3/12/2013,"03/12/2013",6/12/2013,"06/12/2013"
"Food",65063,"Ongoing","SMART AND FINAL STORES CORP","Los Angeles","CA","US","Voluntary: Firm Initiated","E-Mail","CA, NV, OR, WA, ID, AZ","F-1411-2013","Class II","La Romanella Precooked Tri Color Cheese Tortellini, 2.5-lb bag","Best By Dates: 12/25/2013, 1/15/2014, 3/15/2014, 4/2/2014, 4/13/2014, 4/15/2014, 4/16/2014, 5/20/2014, 6/1/2014, 6/3/2014, 7/9/2014, 7/19/2014, 7/29/2014, 8/8/2014, 8/26/2014, 9/9/2014, 9/16/2014, 9/17/2014, 10/2/2014",,"4833 Cases","No ingredient statement on pacakge. Product contains undeclared allergens: wheat, egg, and milk. ",4/25/2013,"04/25/2013",5/22/2013,"05/22/2013"
"Biologics",65065,"Terminated","Hoxworth Blood Center UC Medical Center","Cincinnati","OH","US","Voluntary: Firm Initiated","Letter","Ohio","B-1752-13","Class II","Red Blood Cells (Apheresis) Leukocytes Reduced","W037711145273 Part 1; W037711145273 Part 2; ",,"2","Blood products, which were collected from a donor who traveled to a malarial endemic area, were distributed. ",3/19/2013,"03/19/2013",7/31/2013,"07/31/2013"
"Biologics",65066,"Terminated","Florida's Blood Centers - Lake Park","Palm Beach Gardens","FL","US","Voluntary: Firm Initiated","Letter","Florida","B-1753-13","Class II","Red Blood Cells Leukocytes Reduced","W038112346434; ",,"1","Blood product, which was collected from a donor who traveled to a malarial endemic area, was distributed.",3/7/2013,"03/07/2013",7/31/2013,"07/31/2013"
"Devices",65067,"Ongoing","Polymer Technology Systems, Inc.","Indianapolis","IN","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution - USA Nationwide including Puerto Rico and countries of: UK, CHL, ENG, BEL, ITA, TKY, BEL, LIT, LTV, EGY, SPG, HOK, SWE, MEX, UAE, COR, ISR, MAL, AUS, POR, POL, SLN and STQ.","Z-1403-2013","Class II","PTS PANELS, Glucose Test Strips for use with CardioChek Brand Analyzers Product Usage: used by healthcare professionals and individuals with diabetes to measure glucose in whole blood","U1117",".","7048 total, 3499 in USA","Internal investigation demonstrated under-recovery for glucose when tested against a reference method. This could result in a low to moderate health risk.",4/4/2013,"04/04/2013",6/5/2013,"06/05/2013"
"Devices",65068,"Ongoing","Custom Spine, Inc.","Parsippany","NJ","US","Voluntary: Firm Initiated","E-Mail","Nationwide Distribution including Nebraska and Virginia.","Z-1819-2013","Class II","Custom Spine ISSYS LP Inverted Screw System. 8.5MM X 45 MM ISSYS LP Screw Rx Non-Sterile. Custom Spine, Inc. 9 Campus Dr. Parsippany, NJ 07054 USA. TEL: 973-808-0019 The ISSYS LP Spinal Fixation System is intended to help provide immobilization and stabilization of spinal segments as an adjunct to fusion of the lumbar and/or sacral spine for pedicular and non-pedicular fixation.","Catalog Number 048545; Lot Number L363",,"18 units","On March 28, 2013, Custom Spine, Inc. issued a minor removal of a lot of 18 screws that were found to be out of specification. The screw length was 5 mm shorter in length than the required specification for the screw size. The product is laser marked 8.5mm X 45mm, but its length measured 40mm. ",3/28/2013,"03/28/2013",8/7/2013,"08/07/2013"
"Food",65069,"Ongoing","Winn-Dixie Logistics, Inc.","Jacksonville","FL","US","Voluntary: Firm Initiated","E-Mail","AL, GA, FL, MS, and LA","F-1380-2013","Class II","Winn Dixie Organic 100% Apple Juice from concentrate with added ingredients, 64-fl oz","Lot # 3690230152 exp 1/15/2014 Lot # 3690230292 exp 1/29/2014 Lot # 3690230582 exp 2/27/2014 Lot # 3690230702 exp 3/11/2014 Lot # 3690230702 exp 3/12/2014 Lot # 3690230842 exp 3/25/2014",".","6,104 pieces","The product is being recalled as a precaution because it could have levels of ''patulin'' that exceeds FDA limits.",4/11/2013,"04/11/2013",5/15/2013,"05/15/2013"
"Devices",65070,"Ongoing","Nephron Pharmaceuticals Corp.","Orlando","FL","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution-USA (nationwide) including DC and Puerto Rico and the states of AL, AZ, CA, CO, CT, FL, IL, IN, IO, GA, KS, KY, LA, MD, MN, MS, MO, NK, NV, NJ, NM, NY, OH, OK, OR, PA, RI, SC, TN , TX, VT, VA, WA, and WV, and the countries of Guatemala, Poland, Panama, and United Kingdom.","Z-1373-2013","Class I","EZ Breathe Medication Cup. For the delivery of liquid medications for respiratory usage.","Lots #120902, Lot # 120903 and Lot # 120904",".","750 Medications Cups","Possible dislodgement of the ''Plate A'', if this instance occurs, it presents a potential choking hazard.",4/30/2013,"04/30/2013",6/5/2013,"06/05/2013"
"Devices",65070,"Ongoing","Nephron Pharmaceuticals Corp.","Orlando","FL","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution-USA (nationwide) including DC and Puerto Rico and the states of AL, AZ, CA, CO, CT, FL, IL, IN, IO, GA, KS, KY, LA, MD, MN, MS, MO, NK, NV, NJ, NM, NY, OH, OK, OR, PA, RI, SC, TN , TX, VT, VA, WA, and WV, and the countries of Guatemala, Poland, Panama, and United Kingdom.","Z-1371-2013","Class I","EZ Breathe Atomizer Model # EZ-100. For the delivery of liquid medications for respiratory usage.","Model # EZ-100 Lots # R2029A, R2029B, R2039A, R2042A, R2045A, and R2047A. Atomizer Serial Number Ranges: 1206034476-1206069065 1207003710-1237038299 1207046505-1207081124 1208027421-1208062155 1209000001-1209069179 1209069180-1209069202 1209069203-1209069460 1210000001-1210103680 1210104001-1210104044 ",".","604 each","Possible dislodgement of the ''Plate A'', if this instance occurs, it presents a potential choking hazard.",4/30/2013,"04/30/2013",6/5/2013,"06/05/2013"
"Devices",65070,"Ongoing","Nephron Pharmaceuticals Corp.","Orlando","FL","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution-USA (nationwide) including DC and Puerto Rico and the states of AL, AZ, CA, CO, CT, FL, IL, IN, IO, GA, KS, KY, LA, MD, MN, MS, MO, NK, NV, NJ, NM, NY, OH, OK, OR, PA, RI, SC, TN , TX, VT, VA, WA, and WV, and the countries of Guatemala, Poland, Panama, and United Kingdom.","Z-1372-2013","Class I","Asthmanefrin Starter Kit contains ten (10) Asthmanefrin vials and one (1) EZ Breathe Atomizer. For the delivery of liquid medications for respiratory usage.","Lots # R2029A, R2029B, R2039A, R2042A, R2045A, and R2047A. Atomizer Serial Number Ranges: 1206034476-1206069065 1207003710-1237038299 1207046505-1207081124 1208027421-1208062155 1209000001-1209069179 1209069180-1209069202 1209069203-1209069460 1210000001-1210103680 1210104001-1210104044 ",".","241,538 kits","Possible dislodgement of the ''Plate A'', if this instance occurs, it presents a potential choking hazard.",4/30/2013,"04/30/2013",6/5/2013,"06/05/2013"
"Drugs",65071,"Ongoing","Aurobindo Pharma USA Inc","Plainsboro","NJ","US","Voluntary: Firm Initiated","Letter","Nationwide","D-498-2013","Class III","Lisinopril Tablets, USP, 30 mg, Rx only, 100 tablets, NDC 65862-041-01 Manufactured for: Aurobindo Pharma USA Inc. 2400 Route 130 North, Dayton, NJ 08810 Manufactured by: Aurobindo Pharma Limited Hyderabad- 500 072 India ","Lot KP3012001-A Exp.12/13 Lot KP3012002-A Exp.12/13",".","1776 bottles","Labeling: Label Error on Declared Strength: Incorrect strength on side display panel of label",4/9/2013,"04/09/2013",6/5/2013,"06/05/2013"
"Devices",65072,"Terminated","Intuitive Surgical, Inc.","Sunnyvale","CA","US","Voluntary: Firm Initiated","Letter","USA Nationwide distribution","Z-1426-2013","Class II","Thyroidectomy Indication for the da Vinci Surgical Systems; Product Usage: da Vinci Thyroidectomy offers a minimally invasive surgery for both partial and total thyroidectomy procedures, including endoscopic and video assisted procedure that are preferable to conventional (open) procedures that utilize a cervical incision because they leave no visible neck scar. ","NA - marketing and promotional only.",".","2,423 consignee","Promotional literature for use of the da Vinci system for thyroidectomy, which had not been approved with a change to the 510(k).",10/13/2011,"10/13/2011",6/5/2013,"06/05/2013"
"Devices",65073,"Terminated","Intuitive Surgical, Inc.","Sunnyvale","CA","US","Voluntary: Firm Initiated","Letter","Worldwide distribution - USA Nationwide and the countries of Australia, Austria, Belgium, China, Czech Republic, Denmark, Finland, France, Germany, Greece, India, Ireland, Israel, Italy, Japan, Malaysia, Mexico, Netherlands, New Zealand, Norway, Pakistan, Philippines, Poland, Portugal, Qatar, Romania, Russia, Saudi Arabia, Slovenia, South Korea, Spain, Sweden, Switzerland, Taiwan, Thailand, Turkey, United Kingdom.","Z-1425-2013","Class II","Tip Cover Accessory, 8 MM, MCS, box of 10 Product Usage: The disposable Tip cover accessory is used in conjunction with the 8mm Monopolar Curved Scissors Instruments to cut and coagulate tissue. The tip cover is intended to provide electrical insulation over a section of the Monopolar Curved Scissors instrument so that FR energy is only available at the scissors blades. ","Model numbers: 400180-10 and prior versions 400180-01, 400180-02, 400180-03, 400180-04, 400180-05, 400180-05, 400180-06. 400180-07, 400180-08 and 400180-09.",".","50,000 boxes of 10 tip covers","Clarification of existing labeling and related cautions for the tip cover accessory of the da Vinci Surgical System.",9/23/2011,"09/23/2011",6/5/2013,"06/05/2013"
"Food",65074,"Ongoing","Carson's Country Market","Lockport","NY","US","Voluntary: Firm Initiated","Press Release","New York State","F-1382-2013","Class I","CARSON'S HOMEMADE PIES AND OTHER GOOD THINGS brand FUDGE BROWNIE COOKIES, NET WT. 14 OZ., UPC 7 53182 15240 0 --- Corner Rt 31 + Rt 93, Lockport, NY 14094 - 716-433-2248 (phone) --- The cookies are packaged in clear, hard plastic containers with seven or eight cookies per container. --- INGREDIENTS: COOKIE: Flour, Sugar, Vegetable Shortening, Evaporated Milk, Eggs, Chocolate Chips, Cocoa, Baking Powder, Vanilla. FROSTING: Sugar, Vegetable Oil, Corn Syrup, Cocoa, Mono + Diglycerides, Polysorbate 60, Potassium Sorbate, Citric Acid, Lecithin, Salt, Flavorings.","''Sell by Dates'' of 4/26/2013 to 5/03/13 (date code can be found on the white sticker label found on the top of the hard plastic container) ",,"UNKNOWN","Carson's Fudge Brownie Cookies contain undeclared walnuts, wheat (flour) and soy (lecithin).",4/30/2013,"04/30/2013",5/22/2013,"05/22/2013"
"Food",65074,"Ongoing","Carson's Country Market","Lockport","NY","US","Voluntary: Firm Initiated","Press Release","New York State","F-1383-2013","Class I","CARSON'S HOMEMADE PIES AND OTHER GOOD THINGS brand ASSORTED COOKIE PACK Chocolate Chip - Fudge Brownie - Vanilla Drop - Molasses - Oatmeal Raisin - Peanut Butter - Pumpkin, NET WT. 14 OZ., UPC 7 53182 15240 0 --- Sanborn, NY 14132 --- The cookies are packaged in clear, hard plastic containers with seven or eight cookies per container. --- INGREDIENTS: Veg. Shortening, Flour, Sugar, Eggs, Vanilla. May Contain: Chocolate Chips, Cocoa, Peanut Butter, Milk (Evaporated), Molasses, Oatmeal, Baking Powder, Soda, Cinnamon, Nutmeg, Ginger Or Cloves.","''Sell by Dates'' of 4/26/2013 to 5/03/13 (date code can be found on the white sticker label found on the top of the hard plastic container) ",,"UNKNOWN","Carson's Assorted Cookie Pack contains undeclared walnuts, wheat (flour), milk and peanut (butter). ",4/30/2013,"04/30/2013",5/22/2013,"05/22/2013"
"Food",65075,"Ongoing","Eastland Food Corporation","Jessup","MD","US","Voluntary: Firm Initiated","Letter","The product was distributed in the Eastern half of the US.","F-1391-2013","Class II","Asia Best Salted Mackerel, 7 oz. vacuum packages, 25 pkgs/cases; labeled in part ***Eastland Food Corp. 8305 Stayton Drive Jessup, MD 20794 *** Product of Thailand *** Keep Frozen *** UPC 851035 408024***","Best Before - February 29, 2014",,"210 cases","Salted mackerel contains histamines at a level indicating product decomposition.",5/1/2013,"05/01/2013",5/22/2013,"05/22/2013"
"Biologics",65076,"Terminated","Biotest Pharmaceuticals Corporation","Augusta","GA","US","Voluntary: Firm Initiated","E-Mail","Korea, Republic Of(South)","B-1809-13","Class II","Source Plasma","0380099025; 0380098497; 0380098106; ",,"3","Blood products, collected from a donor who did not have a complete physical examination, were distributed.",3/13/2013,"03/13/2013",7/31/2013,"07/31/2013"
"Drugs",65077,"Ongoing","Hospira Inc.","Lake Forest","IL","US","Voluntary: Firm Initiated","Letter","Nationwide and Puerto Rico","D-313-2013","Class II","Diazepam Injection, USP 5 mg/mL, 10 mL, Multiple-dose fliptop vial, RX only, HOSPIRA, INC. LAKE FOREST, IL 60045 USA, NDC 0409-3213-12","Lot 05-585-EV Exp. 05/13",".","114,000 vials","Lack of Assurance of Sterility: Loose crimp applied to the fliptop vial.",2/26/2013,"02/26/2013",5/15/2013,"05/15/2013"
"Drugs",65077,"Ongoing","Hospira Inc.","Lake Forest","IL","US","Voluntary: Firm Initiated","Letter","Nationwide and Puerto Rico","D-315-2013","Class II","QUELICIN (succinylcholine chloride) Injection, USP, 200 mg (20 mg/mL) 10 mL, Rx only, HOSPIRA, INC. LAKE FOREST, IL 60045 USA, , NDC 0409-6629-02","Lot 21-480-EV Exp.12/13",".","139,200 vials","Lack of Assurance of Sterility: Loose crimp applied to the fliptop vial.",2/26/2013,"02/26/2013",5/15/2013,"05/15/2013"
"Drugs",65077,"Ongoing","Hospira Inc.","Lake Forest","IL","US","Voluntary: Firm Initiated","Letter","Nationwide and Puerto Rico","D-314-2013","Class II","Furosemide Injection, USP, 40 mg/4mL (10 mg/mL), 4 ml Single-Dose Vial, Rx only, HOSPIRA, INC. LAKE FOREST, IL 60045 USA, NDC 0409-6102-04","Lot 20-564-DK Exp. 02/14",".","259,050 vials","Lack of Assurance of Sterility: Loose crimp applied to the fliptop vial.",2/26/2013,"02/26/2013",5/15/2013,"05/15/2013"
"Drugs",65077,"Ongoing","Hospira Inc.","Lake Forest","IL","US","Voluntary: Firm Initiated","Letter","Nationwide and Puerto Rico","D-316-2013","Class II","Sodium Acetate Injection, USP, 40 mEq/20 ml (2 mEq/mL) 20 mL Single-Dose Fliptop, Rx only, HOSPIRA, INC. LAKE FOREST, IL 60045 USA, NDC 0409-7299-73","Lot 23-320-DK and 23-321-DK Exp. 11/14",".","266,900 vials","Lack of Assurance of Sterility: Loose crimp applied to the fliptop vial.",2/26/2013,"02/26/2013",5/15/2013,"05/15/2013"
"Devices",65078,"Ongoing","DePuy Orthopaedics, Inc.","Warsaw","IN","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution - US (nationwide) including the states of IL, OH, NC, SC, MN, NV, TN and WA., and the countries of UK, Netherlands and Canada.","Z-1331-2013","Class III","DePuy LifeLiner Stick & Cut Resistant Gloves Rt, Lg Part No. 5200-68-000 The gloves are designed to resist sticks and cuts and are not cut or puncture proof. These gloves are not required by any surgical technique.","Lot - D12178C ",,"180 gloves (120 gloves distributed in the US)","LifeLiner Stick and Cut Resistant Gloves are being recalled because cases and individual glove packages were mispackaged, with right handed, large sized glove packaging containing left handed, large sized gloves.",5/8/2013,"05/08/2013",5/22/2013,"05/22/2013"
"Food",65079,"Ongoing","Meijer Distribution, Inc","Grand Rapids","MI","US","Voluntary: Firm Initiated","E-Mail","Meijer stores (201) located in Illinois, Indiana, Kentucky, Michigan, and Ohio may have received product from Meijer distribution centers.","F-1454-2013","Class III","Meijer Diced Pears in Fruit Juice 8oz cup","UPC: 71373337044 and All lots produced from November 29, 2012 through January 2, 2013.",".","26,931","Meijer Diced Pears in Fruit Juice, Meijer Diced Peaches in Fruit Juice, and Meijer Mandarin Oranges in Fruit Juice 8 oz (226g) labels were developed, the Serving Size was updated to 1 cup (226g) but the nutrition facts still reflect the 4 oz (113g) information.",4/15/2013,"04/15/2013",6/5/2013,"06/05/2013"
"Food",65079,"Ongoing","Meijer Distribution, Inc","Grand Rapids","MI","US","Voluntary: Firm Initiated","E-Mail","Meijer stores (201) located in Illinois, Indiana, Kentucky, Michigan, and Ohio may have received product from Meijer distribution centers.","F-1456-2013","Class III","Meijer Mandarin Oranges in Fruit Juice 8oz cup","UPC: 88692601216 and All lots produced from November 29, 2012 through January 2, 2013.",".","65,718 ","Meijer Diced Pears in Fruit Juice, Meijer Diced Peaches in Fruit Juice, and Meijer Mandarin Oranges in Fruit Juice 8 oz (226g) labels were developed, the Serving Size was updated to 1 cup (226g) but the nutrition facts still reflect the 4 oz (113g) information.",4/15/2013,"04/15/2013",6/5/2013,"06/05/2013"
"Food",65079,"Ongoing","Meijer Distribution, Inc","Grand Rapids","MI","US","Voluntary: Firm Initiated","E-Mail","Meijer stores (201) located in Illinois, Indiana, Kentucky, Michigan, and Ohio may have received product from Meijer distribution centers.","F-1455-2013","Class III","Meijer Diced Peaches in Fruit Juice 8oz cup","UPC: 71373337017 and All lots produced from November 29, 2012 through January 2, 2013.",".","35,721","Meijer Diced Pears in Fruit Juice, Meijer Diced Peaches in Fruit Juice, and Meijer Mandarin Oranges in Fruit Juice 8 oz (226g) labels were developed, the Serving Size was updated to 1 cup (226g) but the nutrition facts still reflect the 4 oz (113g) information.",4/15/2013,"04/15/2013",6/5/2013,"06/05/2013"
"Devices",65080,"Ongoing","Fresenius Medical Care Holdings, Inc. dba Renal Solutions","Warrendale","PA","US","Voluntary: Firm Initiated","Letter","USA Nationwide Distribution in the states of CA, MA, and NY.","Z-2082-2013","Class II","2008 MeDS Pump, Venofer(R) Pump Product Usage: The 2008 MeDs pump is an optional accessory for use with the Fresenius 2008 Series Hemodialysis Machines and is intended to administer Venofer to treat iron deficiency anemia in patients with chronic kidney disease undergoing hemodialysis, where Venofer, in conjunction with hemodialysis, is prescribed by a physician.","Serial numbers - TM-001065, TM-001283, TM-001284, TM-001325, TM-001411, TM-001426, TM-001465, TM-001476, TM-001529, TM-001967, TM-001968, TM-001975, TM-001985, TM-002015, TM-002016, TM-002017, TM-002018, TM-002021, TM-002022, TM-002095, TM-000015, TM-000028, TM-000031, TM-000041, TM-0048, TM-000050, TM-000051, TM-000053, TM-000055, TM-000059, TM-000064, TM-000065, TM-000068, TM-0069, TM-000213, TM-000215, TM-000218, TM-000219, TM-000070, TM-000072, TM-000074, TM-000075, TM-000078, TM-000081, TM-000082, TM-000083, TM-000085, TM-000086, TM-000087, TM-000088, TM-000089, TM-000092, TM-000040, TM-000077, TM-000098, TM-000101, TM-000102, TM-000103, TM-000104, TM-000105, TM-000106, TM-000107, TM-000108, TM-000109, TM-000112, TM-000113, TM-000114, TM-000115, TM-000116, TM-000122, TM-000123, TM-000124, TM-000125, TM-000126, TM-000128, TM-000145, TM-000002, TM-000003, TM-000004, TM-000005, TM-000006, TM-000007, TM-000008, TM-000009, TM-000010, TM-000012, TM-000013, TM-000014, TM-000017, TM-000018, TM-000019, TM-000020, TM-000023, TM-000024, TM-000025, TM-000033, TM-000036, TM-A595, TM-A610, TM-A627, TM-000220, TM-000227, TM-007364, TM-007371, TM-006848, TM-006860, TM-006875, TM-006879, TM-006880, TM-006881, TM-006882, TM-006883, TM-006884, TM-006885, TM-006886, TM-006887, TM-006890, TM-006891, TM-006892, TM-006893, TM-006897, TM-006898, TM-006911, TM-006912, TM-006913, TM-006914, TM-006915, TM-006916, TM-006917, TM-006918, TM-006919, and TM-006920. ",,"132","Product is being recalled because the combination of the current 50 mg vial, the 2008 MeDS pump, and the 2008 MeDS pump tubing Set for CombiSet Bloodlines can lead to a situation where Venofer(R) delivery does not meet dosage accuracy requirements. This may lead to a slight over or under delivery of Venofer(R) that does not pose an acceptable risk to the patient. Please note that this recall does not affect the CombiSet Bloodlines or 50 mg Venofer(R) vials. The 50 mg Venofer(R) vial can continue to be used for manual drug delivery via syringe.",4/1/2013,"04/01/2013",9/4/2013,"09/04/2013"
"Devices",65081,"Ongoing","DePuy Orthopaedics, Inc.","Warsaw","IN","US","Voluntary: Firm Initiated","E-Mail","Worldwide Distribution - USA Nationwide and countries of: Australia, Canada, Czech Republic, England, Germany, Switzerland and Turkey.","Z-1520-2013","Class II","DePuy Glenosphere orientation guide Product Usage: The glenosphere orientation guide is an instrument used in reverse shoulder arthroplasty. The orientation guide is used to properly align the glenosphere.","Part Number 230795000/Lot Number 5120443",".","20 units","The Glenosphere Orientation Guide Instrument Used with the Delta XTEND Reverse Shoulder is being recalled because an arrow that is etched on the instrument was incorrectly placed on the opposite side of the instrument. Using the improperly etched arrow as a guide could potentially lead to incorrect orientation of the glenosphere implant. ",5/3/2013,"05/03/2013",6/19/2013,"06/19/2013"
"Devices",65082,"Ongoing","Canon Inc.","Tokyo",,"JP","Voluntary: Firm Initiated","Letter","Worldwide Distribution - USA Nationwide and countries of: Australia, Japan, Korea, Singapore and United Kingdom.","Z-1404-2013","Class II","Canon Full Auto Ref-Keratometer RK-F2, Catalog Number 6937B002AA. Product Usage: This device is intended to be used to measure the refractive power and the radius of corneal curvature of the human eye.","Catalog Number 6937B002AA. All serial numbers from the first unit onward.",".","384 units","Canon Inc. had received 17 claims from our foreign sales companies between October to November 2012 that measurement value of RK-F2s refractive power (SPH value) sometimes indicated abnormal value which occurs approximately 5% in probability.",12/5/2012,"12/05/2012",6/5/2013,"06/05/2013"
"Devices",65083,"Terminated","Intuitive Surgical, Inc.","Sunnyvale","CA","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution- USA Nationwide and countries of: Argentina, Australia,Canada, Chile, China, Czech Republic, Egypt, India, Israel, Italy,Korea-Republic of, Poland, Qatar, Romania, Saudi Arabia, Singapore, Spain, Thailand, Turkey, and Venezuela.","Z-1427-2013","Class II","Cannula 8MM Regular. Provides the means of introduction and placement of an instrument or accessory into the human body. ","Model number 420002-07",".","NA","Clarification of existing labeling information and operating procedures.",9/19/2011,"09/19/2011",6/5/2013,"06/05/2013"
"Devices",65083,"Terminated","Intuitive Surgical, Inc.","Sunnyvale","CA","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution- USA Nationwide and countries of: Argentina, Australia,Canada, Chile, China, Czech Republic, Egypt, India, Israel, Italy,Korea-Republic of, Poland, Qatar, Romania, Saudi Arabia, Singapore, Spain, Thailand, Turkey, and Venezuela.","Z-1428-2013","Class II","Flush Port (used in almost all da Vinci instruments) Assists in cleaning the instrument. ","Model numbers: 340066-07 - straight; 340234-02 - extended taper; 340241-03 - 5mm; 340584-01 - Gemini 8mm straight; 340586-02 - Gemini 5mm; 340725-01 - Vespa straight; 340800-01 - Gemini ext taper; 340971-01 - IS1200 Grasping 340972-01 IS2000 Grasping.",".","NA","Clarification of existing labeling information and operating procedures.",9/19/2011,"09/19/2011",6/5/2013,"06/05/2013"
"Devices",65083,"Terminated","Intuitive Surgical, Inc.","Sunnyvale","CA","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution- USA Nationwide and countries of: Argentina, Australia,Canada, Chile, China, Czech Republic, Egypt, India, Israel, Italy,Korea-Republic of, Poland, Qatar, Romania, Saudi Arabia, Singapore, Spain, Thailand, Turkey, and Venezuela.","Z-1429-2013","Class II","da Vinci Si Surgeon Console. Intended to assist in the accurate Control of Intuitive Surgical Endoscopic Instruments. ","Model number: 314850, versions 1-6 ",".","NA","Clarification of existing labeling information and operating procedures.",9/19/2011,"09/19/2011",6/5/2013,"06/05/2013"
"Devices",65084,"Ongoing","Wako Life Sciences, Inc.","Mountain View","CA","US","Voluntary: Firm Initiated","Letter","Distribution to CA, GA, MN, NC, UT and the District of Columbia.","Z-1831-2013","Class II","uTASWako DCP, Lot TG340 2013.11, REF 995-60701, Wako Pure Chemical Industries, Ltd. 1-2 Doshomachi 3-chome, Chuo-Ku Osaka 540-8605 Japan Distributed by Wako Diagnostics Wako Life Sciences, Inc. 1025 Terra Bella Ave., Suto A. Mountain View, CA 94043 USA. The product is a single reagent cartridge run on an automated system and each assay performed on a single disposable chip using microfluidic electrophoretic separation. The reagent cartridge contains various buffers and antibodies.","TG340, Exp. 11/30/13",,"36 cartridges -100 tests per cartridge","Product fails to meet the accuracy at the low end of the measuring range.",4/30/2013,"04/30/2013",8/7/2013,"08/07/2013"
"Devices",65085,"Ongoing","Heart Sync, Inc","Ann Arbor","MI","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Worldwide Distribution - USA including AL, GA, MI, MN, NC, ND, OH, PA, SD, VA, VT, OH, TX, MA, and Internationally to Korea.","Z-1435-2013","Class II","Vermed, Inc Radiotransparent Defibrillation Electrodes Monophasic or biphasic compatible defibrillation/cardioversion/pacing/ECG Monitoring electrodes. Used in connection with a defibrillator to deliver an electrical current (shock) to the patient's heart during cardiac emergencies. ","Part Number: D304 and lot numbers:Y100112-02, Y102212-03, Y121312-18, Y012413-02, Y022013-01, Y032113-01",".","17180 units for all part numbers","On 4/18/13 HEARTSYNC became aware of a recall from their wire/connector sub-assembly supplier which is used in the C100-Physio Electrodes. There were reports of equipment damage due to misalignment from tooling installed in August 2012. The result of this damage could render the device incapable of delivering the appropriate energy or shock to the patient.",4/26/2013,"04/26/2013",6/5/2013,"06/05/2013"
"Devices",65085,"Ongoing","Heart Sync, Inc","Ann Arbor","MI","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Worldwide Distribution - USA including AL, GA, MI, MN, NC, ND, OH, PA, SD, VA, VT, OH, TX, MA, and Internationally to Korea.","Z-1434-2013","Class II","Heart Sync C100-Physio Radiotransparent Defibrillation Electrodes Monophasic or biphasic compatible pacing/ cardioversion Defibrillation /ECG Monitoring electrodes Used in connection with a defibrillator to deliver an electrical current (shock) to the patient's heart during cardiac emergencies. ","Part number : C100-Physio and Lot numbers: Y100112-02, Y102212-03, Y121312-18, Y012413-02, Y022013-01, Y032113-01",".","17180 units for all part numbers","On 4/18/13 HEARTSYNC became aware of a recall from their wire/connector sub-assembly supplier which is used in the C100-Physio Electrodes. There were reports of equipment damage due to misalignment from tooling installed in August 2012. The result of this damage could render the device incapable of delivering the appropriate energy or shock to the patient.",4/26/2013,"04/26/2013",6/5/2013,"06/05/2013"
"Biologics",65086,"Terminated","Northern California Community Blood Bank","Eureka","CA","US","Voluntary: Firm Initiated","FAX","California","B-1810-13","Class II","Platelets Pheresis Leukocytes Reduced Irradiated","W149513934421Part 1 ; W149513934421Part 2; ",,"2","Blood products, which were labeled as leukoreduced, but were not tested to verify the White Blood Cell count, were distributed",3/19/2013,"03/19/2013",7/31/2013,"07/31/2013"
"Biologics",65087,"Terminated","University Of Miami Miller School of Medicine Tissue Bank","Miami","FL","US","Voluntary: Firm Initiated","E-Mail","Greece","B-1747-13","Class II","Fascia","0087040077",".","1 allograft","Human tissue allograft, processed in a manner that could cause contamination or cross-contamination during processing, as well as the introduction, transmission, or spread of communicable disease through the use of the HCT/P, was distributed. ",2/21/2013,"02/21/2013",7/17/2013,"07/17/2013"
"Devices",65088,"Ongoing","Paa Laboratories Inc","Etobicoke","ON","CA","Voluntary: Firm Initiated","Letter","Worldwide Distribution - USA (nationwide), and countries of: Canada and Novia Scotia.","Z-1735-2013","Class II","Various types of Fetal Bovine Serum Bovine sourced Animal Sera for in-vitro diagnostic device and as a growth promoting nutrient in cell culture systems. ","510 k exempt No Medical Device Listing number All batches produced within the last 5 years (143 batches)",".","approximately 280,000 liters","Current product labeling band data sheets state that FBS Pharma Grade and FBS/FBS Native are pure Fetal Bovine Serum (FBS). These products may contain added adult Bovine Serum Albumin (BSA)of United States origin, water, and/or cell growth promoting additives. All other FBS products, as listed below, including FBS Gold and FBS Standard, described as specialty sera', may contain adult BSA of United States origin, water, and/or cell growth promoting additives.",4/12/2013,"04/12/2013",7/24/2013,"07/24/2013"
"Devices",65089,"Ongoing","Becton Dickinson & Co.","Sparks","MD","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Worldwide Distribution - USA Nationwide and tthe countries of Australia, Canada, Europe, Hong Kong, Mexico, New Zealand, Singapore, and Taiwan.","Z-1422-2013","Class II","BBL DrySlide PYR Kit, catalog number 231747 Product Usage: Presumptive diagnostic aid for group A streptococci and group D enterococci bacteria. ","PYR kit - lot 2276481 with expiration date 09/30/13 ",".","610 total test kits (PYR and Oxidase)","In-vitro diagnostic agents were placed into incorrect packaging for distribution to microbiological laboratories.",4/12/2013,"04/12/2013",6/5/2013,"06/05/2013"
"Devices",65089,"Ongoing","Becton Dickinson & Co.","Sparks","MD","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Worldwide Distribution - USA Nationwide and tthe countries of Australia, Canada, Europe, Hong Kong, Mexico, New Zealand, Singapore, and Taiwan.","Z-1423-2013","Class II"," BBL DrySlide Oxidase Kit, catalog number 231746 Product Usage: Presumptive diagnostic aid for gram-negative bacteria. ","Oxidase kit - lot 2222008 with expiration date 08/31/13",".","610 total test kits (PYR and Oxidase)","In-vitro diagnostic agents were placed into incorrect packaging for distribution to microbiological laboratories.",4/12/2013,"04/12/2013",6/5/2013,"06/05/2013"
"Devices",65090,"Ongoing","Fresenius Medical Care Holdings, Inc.","Waltham","MA","US","Voluntary: Firm Initiated","Letter","Nationwide Distribution including the states of AR, CA, FL, GA, KY, LA, MA, MD, NC, NJ, NY, PA, PR, SC, TX and VA.","Z-1693-2013","Class II","Fresenius Service Replacement 0-Ring. Used in as a service part in 4 sub-assemblies manufactured and/or refurbished Fresenius hemodialysis machines, models 2008K, 2008K2, 2008K@Home and 2008T ","Part Number: 640919",".","725 units","Incorrect rubber nitrile O-rings distributed instead of the correct material EPDM. (Ethylene Propylene Dine Monomer (M-class) rubber)",5/24/2013,"05/24/2013",7/17/2013,"07/17/2013"
"Devices",65091,"Ongoing","OrthoPediatrics Corp","Warsaw","IN","US","Voluntary: Firm Initiated","Telephone","USA Nationwide Distribution","Z-1536-2013","Class II","90 Degree Cannulated Infant Blade Plate 35mm x 5mm x 3 Hole Product Usage: The OrthoPediatrics Locking Cannulated Blade Plate System is intended for fixation of long bone fractures and osteotomies in all pediatric subgroups (except neonates) and in small stature adults. Specific indications include: intertrochanteric derotation and varus osteotomies, femoral neck and pertrochanteric fractures, intertrochanteric valgus osteotomies, proximal and distal tibial osteotomies and humeral fractures and osteotomies.","All lot numbers are affected. Catalog No. 00-1200-1002",".","130 devices were shipped","Post Market Surveillance of the 90 degree Cannulated Infant Blade Plate indicated that there have been five reports concerning bending of the plate intra-operatively. ",4/19/2013,"04/19/2013",6/19/2013,"06/19/2013"
"Devices",65091,"Ongoing","OrthoPediatrics Corp","Warsaw","IN","US","Voluntary: Firm Initiated","Telephone","USA Nationwide Distribution","Z-1534-2013","Class II","90 Degree Cannulated Infant Blade Plate 25mm x 5mm x 3 Hole Product Usage: The OrthoPediatrics Locking Cannulated Blade Plate System is intended for fixation of long bone fractures and osteotomies in all pediatric subgroups (except neonates) and in small stature adults. Specific indications include: intertrochanteric derotation and varus osteotomies, femoral neck and pertrochanteric fractures, intertrochanteric valgus osteotomies, proximal and distal tibial osteotomies and humeral fractures and osteotomies.","All lot numbers are affected. Catalog No. 00-1200-1000",".","130 devices were shipped","Post Market Surveillance of the 90 degree Cannulated Infant Blade Plate indicated that there have been five reports concerning bending of the plate intra-operatively. ",4/19/2013,"04/19/2013",6/19/2013,"06/19/2013"
"Devices",65091,"Ongoing","OrthoPediatrics Corp","Warsaw","IN","US","Voluntary: Firm Initiated","Telephone","USA Nationwide Distribution","Z-1535-2013","Class II","90 Degree Cannulated Infant Blade Plate 30mm x 5mm x 3 Hole Product Usage: The OrthoPediatrics Locking Cannulated Blade Plate System is intended for fixation of long bone fractures and osteotomies in all pediatric subgroups (except neonates) and in small stature adults. Specific indications include: intertrochanteric derotation and varus osteotomies, femoral neck and pertrochanteric fractures, intertrochanteric valgus osteotomies, proximal and distal tibial osteotomies and humeral fractures and osteotomies.","All lot numbers are affected. Catalog No. 00-1200-1001",".","130 devices were shipped ","Post Market Surveillance of the 90 degree Cannulated Infant Blade Plate indicated that there have been five reports concerning bending of the plate intra-operatively. ",4/19/2013,"04/19/2013",6/19/2013,"06/19/2013"
"Drugs",65092,"Ongoing","Alkermes, Inc.","Waltham","MA","US","Voluntary: Firm Initiated","Letter","Nationwide","D-819-2013","Class II","VIVITROL (naltrexone for extended-release injectable suspension) a) 380 mg vial NDC 65757-303-02, b) 380 mg vial in kit NDC 65757-300-01, Rx Only Manufactured and marketed by Alkermes, Inc., Waltham, MA 02451,","Individual vial lot 402-3683AA, EXP 10/13; kit vial lot 2011-003, EXP 08/13",,"3,325 vials","Lack of Assurance of Sterility: Product did not meet the criteria for container closure integrity testing during routine 24 month stability testing.",11/6/2012,"11/06/2012",7/31/2013,"07/31/2013"
"Devices",65093,"Ongoing","Covidien LP","North Haven","CT","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution - USA (nationwide) and internationally to the following countries: Canada Austria Bahrain Benoni Centurion Chatsworth Czech Republic Denmark Egypt Finland France Germany Ireland Israel Italy Japan Kuwait Netherlands Norway Portugal QATAR Saudi Arabia Serbia Singapore South Africa Spain OMAN Sweden Switzerland UAE United Kingdom Venezuela","Z-1468-2013","Class II","Versaport Bladeless Optical Trocar With Fixation Cannula - 5mm Short Product Code: ONB5SHF The Versaport'' Bladeless Optical 5mm trocars are intended for use in a variety of gynecologic, general, thoracic and urologic endoscopic procedures to create and maintain a port of entry.","Lot Numbers: N2h0413X through N3A0391X Note: The specific lot numbers listed below are not affected by this recall and are acceptable for use: N2H0045X,N2H0166X,N2H0286X, N2H0357X,N2 H051 6UX",".","23050 units","Seals may disengage from the cannula which may result in a component inadvertently disengaging into the patients cavity",5/6/2013,"05/06/2013",6/12/2013,"06/12/2013"
"Devices",65093,"Ongoing","Covidien LP","North Haven","CT","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution - USA (nationwide) and internationally to the following countries: Canada Austria Bahrain Benoni Centurion Chatsworth Czech Republic Denmark Egypt Finland France Germany Ireland Israel Italy Japan Kuwait Netherlands Norway Portugal QATAR Saudi Arabia Serbia Singapore South Africa Spain OMAN Sweden Switzerland UAE United Kingdom Venezuela","Z-1471-2013","Class II","Versaport Bladeless Optical Fixation Cannula - 5mm Short Product Code: ONBFCA5SH The Versaport'' Bladeless Optical 5mm trocars are intended for use in a variety of gynecologic, general, thoracic and urologic endoscopic procedures to create and maintain a port of entry.","Lot Numbers: N2J0315X through N3A0389X Note: The specific lot numbers listed below are not affected by this recall and are acceptable for use: N2H0045X,N2H0166X,N2H0286X, N2H0357X,N2 H051 6UX",".","2705 units","Seals may disengage from the cannula which may result in a component inadvertently disengaging into the patients cavity",5/6/2013,"05/06/2013",6/12/2013,"06/12/2013"
"Devices",65093,"Ongoing","Covidien LP","North Haven","CT","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution - USA (nationwide) and internationally to the following countries: Canada Austria Bahrain Benoni Centurion Chatsworth Czech Republic Denmark Egypt Finland France Germany Ireland Israel Italy Japan Kuwait Netherlands Norway Portugal QATAR Saudi Arabia Serbia Singapore South Africa Spain OMAN Sweden Switzerland UAE United Kingdom Venezuela","Z-1470-2013","Class II","Versaport Bladeless Optical Trocar With (2) Fixation Cannulae - 5mm Product Code: ONB5STF2C The Versaport'' Bladeless Optical 5mm trocars are intended for use in a variety of gynecologic, general, thoracic and urologic endoscopic procedures to create and maintain a port of entry.","Lot Numbers: N2J0211X through N3D0118X Note: The specific lot numbers listed below are not affected by this recall and are acceptable for use: N2H0045X,N2H0166X,N2H0286X, N2H0357X,N2 H051 6UX",".","5364 units","Seals may disengage from the cannula which may result in a component inadvertently disengaging into the patients cavity",5/6/2013,"05/06/2013",6/12/2013,"06/12/2013"
"Devices",65093,"Ongoing","Covidien LP","North Haven","CT","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution - USA (nationwide) and internationally to the following countries: Canada Austria Bahrain Benoni Centurion Chatsworth Czech Republic Denmark Egypt Finland France Germany Ireland Israel Italy Japan Kuwait Netherlands Norway Portugal QATAR Saudi Arabia Serbia Singapore South Africa Spain OMAN Sweden Switzerland UAE United Kingdom Venezuela","Z-1469-2013","Class II","Versaport Bladeless Optical Trocar With Fixation Cannula - 5mm Product Code: ONB5STF The Versaport'' Bladeless Optical 5mm trocars are intended for use in a variety of gynecologic, general, thoracic and urologic endoscopic procedures to create and maintain a port of entry.","Lot Numbers: N2H0353X through N3D0033X Note: The specific lot numbers listed below are not affected by this recall and are acceptable for use: N2H0045X,N2H0166X,N2H0286X, N2H0357X,N2 H051 6UX",".","126925 units","Seals may disengage from the cannula which may result in a component inadvertently disengaging into the patients cavity",5/6/2013,"05/06/2013",6/12/2013,"06/12/2013"
"Devices",65093,"Ongoing","Covidien LP","North Haven","CT","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution - USA (nationwide) and internationally to the following countries: Canada Austria Bahrain Benoni Centurion Chatsworth Czech Republic Denmark Egypt Finland France Germany Ireland Israel Italy Japan Kuwait Netherlands Norway Portugal QATAR Saudi Arabia Serbia Singapore South Africa Spain OMAN Sweden Switzerland UAE United Kingdom Venezuela","Z-1472-2013","Class II","Versaport Bladeless Optical Fixation Cannula - 5mm Product Code: ONBFCA5ST The Versaport'' Bladeless Optical 5mm trocars are intended for use in a variety of gynecologic, general, thoracic and urologic endoscopic procedures to create and maintain a port of entry.","Lot Numbers: N2J0150X through N3C0683X Note: The specific lot numbers listed below are not affected by this recall and are acceptable for use: N2H0045X,N2H0166X,N2H0286X, N2H0357X,N2 H051 6UX",".","57461 untis","Seals may disengage from the cannula which may result in a component inadvertently disengaging into the patients cavity",5/6/2013,"05/06/2013",6/12/2013,"06/12/2013"
"Devices",65093,"Ongoing","Covidien LP","North Haven","CT","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution - USA (nationwide) and internationally to the following countries: Canada Austria Bahrain Benoni Centurion Chatsworth Czech Republic Denmark Egypt Finland France Germany Ireland Israel Italy Japan Kuwait Netherlands Norway Portugal QATAR Saudi Arabia Serbia Singapore South Africa Spain OMAN Sweden Switzerland UAE United Kingdom Venezuela","Z-1467-2013","Class II","Versaport Bladeless Optical Trocar With Fixation Cannula - 5mm Long Product Code: ONB5LGF The Versaport'' Bladeless Optical 5mm trocars are intended for use in a variety of gynecologic, general, thoracic and urologic endoscopic procedures to create and maintain a port of entry.","Lot Numbers: N2H0414X through N3A0294X Note: The specific lot numbers listed below are not affected by this recall and are acceptable for use: N2H0045X,N2H0166X,N2H0286X, N2H0357X,N2 H051 6UX",".","2716 units","Seals may disengage from the cannula which may result in a component inadvertently disengaging into the patients cavity",5/6/2013,"05/06/2013",6/12/2013,"06/12/2013"
"Devices",65094,"Terminated","Intuitive Surgical, Inc.","Sunnyvale","CA","US","Voluntary: Firm Initiated","Letter","US Distribution Only","Z-1424-2013","Class II","User Manual addendum, TORS for da Vinci Surgical System IS 1200, IS 2000 and IS 3000. Product Usage: The user manual for Transoral Surgery (TORS) provided information to update and replace the Indications for Use and Representative uses section and add the section Warnings for Transoral Otolaryngology Surgery. ","Model number 552002-01",".","1,374 ","Change to User Manual to remove one indication for use and amend warnings to emphasize restrictions for use.",1/24/2013,"01/24/2013",6/5/2013,"06/05/2013"
"Devices",65096,"Ongoing","Boston Scientific CRM Corp","Saint Paul","MN","US","Voluntary: Firm Initiated","FAX","Nationwide Distribution including DC and PR","Z-1339-2013","Class II","LATITUDE Patient Management System, Model 6488, Version 7.3. The LATITUDE Patient Management system is intended for use to remotely communicate with a compatible Boston Scientific pulse generator and transfer data to a central database.","n/a",".","1","Boston Scientific CRM is conducting a recall on the LATITUDE Patient Management System Model 6488 Version 7.3 because between March 4 and 27, 2013, a Siebel release caused ~5000 distributed PMR clinic faxes to display with illegible characters and not the required, Patient non-compliance information that was intended. ",4/10/2013,"04/10/2013",5/29/2013,"05/29/2013"
"Devices",65098,"Ongoing","American Optisurgical Inc","Lake Forest","CA","US","Voluntary: Firm Initiated","Letter","Nationwide Distribution-USA (nationwide) including the states of AZ, CA, FL, GA, IL, KS, MA, MI, NC, NJ, OH, PA, TN, TX, VA, and WI.","Z-1505-2013","Class II","FAST Procedure Kit. Intended for use as a Minor Surgical Procedures Tray.","Lot Numbers 07912-06 12912-04",".","63 individual applicators","American Optisurgical, Inc initiated a recall of ChloraPrep Hi-Lite Orange 3mL Applicator, in response to a sub-recall letter from Medline Industries, Inc due to lack of sterility assurance caused by an incomplete seal on the individual unit packaging.",4/30/2013,"04/30/2013",6/12/2013,"06/12/2013"
"Food",65099,"Ongoing","Hazelnut Growers of Oregon","Cornelius","OR","US","Voluntary: Firm Initiated","E-Mail","distributed in Canada only.","F-1532-2013","Class I","Jumbo Barcelona in-shell hazelnuts and Large Barcelona in-shell hazelnuts, raw, Hazelnut Growers of Oregon Brand, package in bulk 50 pound screen-printed fabric sack. The product is labeled in parts: ''***IN SHELL HAZELNUTS***HAZELNUT GROWERS OF OREGON***OREGON U.S. NO. 1***Hazelnut Growers of Oregon***401 N. 26 Avenue, Cornelius, Oregon 97113***''. ","Lot A102112. This code represents day shift, date of production is October 21, 2012. There is no expiration date on the product. ",".","5000 lbs. Jumbo Barcelona and 5000 lbs. Large Barcelona in-shell hazelnuts","Large and Jumbo in-shell Barcelona Hazelnuts (50 lbs. bulk bags) are recalled due to a potential contamination with Salmonella.",5/2/2013,"05/02/2013",6/19/2013,"06/19/2013"
"Biologics",65100,"Terminated","Blood Systems, Inc","Billings","MT","US","Voluntary: Firm Initiated","Telephone","Montana","B-1811-13","Class II","Red Blood Cells Leukocytes Reduced","W042313005162D; ",,"1","Blood products, which were not manufactured in accordance to acceptable product specifications, were distributed.",3/25/2013,"03/25/2013",7/31/2013,"07/31/2013"
"Biologics",65102,"Terminated","OneBlood, Inc.","Orlando","FL","US","Voluntary: Firm Initiated","Letter","Florida","B-1856-13","Class II","Platelets Pooled Leukocytes Reduced","W038112986694; ",,"1","Blood products, collected from a donor who traveled to an area considered endemic for malaria, were distributed.",3/22/2013,"03/22/2013",7/31/2013,"07/31/2013"
"Biologics",65102,"Terminated","OneBlood, Inc.","Orlando","FL","US","Voluntary: Firm Initiated","Letter","Florida","B-1855-13","Class II","Red Blood Cells Leukocytes Reduced","W038112371216; ",,"1","Blood products, collected from a donor who traveled to an area considered endemic for malaria, were distributed.",3/22/2013,"03/22/2013",7/31/2013,"07/31/2013"
"Biologics",65103,"Terminated","Talecris Plasma Resources Inc","Research Triangle Park","NC","US","Voluntary: Firm Initiated","FAX","North Carolina","B-1857-13","Class III","Source Plasma","3790262030; 3790281497; 3790260795; 3790260536; 3790260073; 3790259619; 3790259388; 3790258872; 3790258627; 3790257457; 3790256939; 3790258833; 3790256107; 3790255821; 3790255343; 3790255075; 3790254093; 3790253834; 3790253273; 3790252998; 3790252179; 3790251046; 3790250913; 3790250293; 3790249853; 3790249353; 3790248961; 3790248519; 3790248074; 3790247204; 3790248896; 3790248294; 3790245959; 3790245385; 3790245071; 3790244522; 3790244236; 3790243660; 3790262852; ",,"39","Blood products, collected from donors, whose suitability to donate was not adequately determined, were distributed.",3/28/2013,"03/28/2013",7/31/2013,"07/31/2013"
"Biologics",65104,"Terminated","Northern Illinois Blood Bank dba Rock River Valley BC","Rockford","IL","US","Voluntary: Firm Initiated","FAX","Indiana","B-1858-13","Class II","Red Blood Cells Leukocytes Reduced","W044412606060; ",,"1","Blood product, collected from a donor who traveled to an area considered endemic for malaria, was distributed.",4/17/2013,"04/17/2013",7/31/2013,"07/31/2013"
"Biologics",65105,"Terminated","Community Blood Center of Carolinas","Charlotte","NC","US","Voluntary: Firm Initiated","Telephone","North Carolina","B-1859-13","Class II","Platelets Pheresis Leukocytes Reduced","W227013003230; ",,"1","Blood product, which was collected from a donor who traveled to a malarial endemic area, was distributed. ",4/3/2013,"04/03/2013",7/31/2013,"07/31/2013"
"Food",65106,"Ongoing","Nestle USA, Inc - Northbrook Pizza Head Office","Northbrook","IL","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","US nationwide distribution only. NO OUS.","F-1468-2013","Class II","DiGiorno pizzeria, bianca/white pizza , Net Wt.18.0 OZ (510 g), UPC 71921-91484 ","Production code: 3068525951",".","5,958 cases (10 pizzas/case)","Plastic contamination. Four pizzas with specific production codes, are being recalled because they may contain fragments of clear plastic",5/2/2013,"05/02/2013",6/12/2013,"06/12/2013"
"Food",65106,"Ongoing","Nestle USA, Inc - Northbrook Pizza Head Office","Northbrook","IL","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","US nationwide distribution only. NO OUS.","F1467-2013","Class II","california Pizza Kitchen crispy thin crust, White, Crispy thin crust pizza topped with garlic creme fraiche sauce, spinach, garlic, mozzarella,cheeses, parmesan, asiago and romano cheeses. Net Wt.12.8 OZ (363 g), UPC 71921-98745 ","Production codes: 3062525951, 3062525952. and 3063525951",".","16,163 cases (14 pizzas/case)","Plastic contamination. Four pizzas with specific production codes, are being recalled because they may contain fragments of clear plastic",5/2/2013,"05/02/2013",6/12/2013,"06/12/2013"
"Devices",65108,"Ongoing","American Optisurgical Inc","Lake Forest","CA","US","Voluntary: Firm Initiated","Letter","Worldwide Disitribution - USA Nationwide in the states of Alabama, Arkansas, Arizona, California, Colorado, Delaware, Florida, Georgia, Iowa, Illinois, Indiana, Kansas, Kentucky, Massachusetts, Maryland, Michigan, Minnesota, Missouri, North Carolina, Nebraska, New Hampshire, New Jersey, New Mexico, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, South Carolina, Tennessee, Texas, Utah, Virginia, Vermont, Washington, Wisconsin, West Virginia, Wyoming and the countries of Quezon City, Philippines, Singapore, and Panama City, Panama.","Z-1518-2013","Class II","TX1 Tissue Removal System disposable handpieces. Product Usage: The TX1 Tissue Removal System is indicated for use in surgical procedures where fragmentation, emulsification and aspiration of soft tissue are desirable, including General Surgery, Orthopedic Surgery, Laparoscopic Surgery and Plastic and Reconstructive Surgery.","Lot Numbers: 00312-07 00713-06 00912-01 01813-02 02413-04 03113-02 04213-01 05113-01 05113-02 05512-03 05713-03 06313-05 06512-08 06513-02 07213-04 07912-06 08212-07 09412-03 11412-06 11612-05 12912-04 14512-07 15312-03 16412-07 17412-01 18712-06 19812-13 20212-03 21412-03 22212-03 23412-06 24112-06 24212-04 24912-13 25712-01 26912-01 27712-05 28512-03 28912-03 29612-01 30512-02 31112-05 32112-03 33112-01 34712-05 36612-01",".","1,436 units","American Optisurgical, Inc. is recalling certain lots of TX1 Tissue Removal System disposable handpiece due to inventory being released into distribution without a cleared FDA 510(k) to cover recent product changes. Use of this product may lead to an underperformance of the device.",4/30/2013,"04/30/2013",6/19/2013,"06/19/2013"
"Devices",65109,"Ongoing","Carl Zeiss Meditec, Inc.","Dublin","CA","US","Voluntary: Firm Initiated","Letter","US Nationwide Distribution.","Z-1440-2013","Class II","Zeiss brand OPMI Pentero C, Surgical microscope and accessories, Model: OPMI Pentero C, Product Numbers: 302583-9001-000 (PENTERO C), and 305961-0000-00 (Ceiling Mount for PENTERO C), Product Usage: A surgical microscope and accessories is an AC-powered device intended for use during surgery to provide a magnified view of the surgical field. ","Serial Numbers: 6725000708, 6725000709, 6725000710, 6725000713, 6725100725, 6725120813",".","6 units","Carl Zeiss Meditec is conducting a field corrective action for its OPMI Pentero C surgical microscope system. During a routine inspection, one microscope installation was found to have 3 (three) broken screws out of 6 (six) in the lower section of the ceiling mount. ",4/18/2013,"04/18/2013",6/12/2013,"06/12/2013"
"Food",65111,"Ongoing","Novartis Consumer Health","Lincoln","NE","US","Voluntary: Firm Initiated","Letter","Product was distributed nationwide and included military distribution. Foreign distribution was made to Panama and Belize.","F-1959-2013","Class II","Benefiber Fiber Supplement, Orange Natural Flavor, Non-Thickening Powder, Sugar Free, packaged in 5.7-oz. (35 servings) bottles, UPC 300670068356, 9.4-oz (58 servings) bottles, UPC 300670068585, and 18.7-oz. (115 servings) bottles, UPC 300670068158. Distributed by: Novartis Consumer Health, Inc., Parsippany, NJ 07054-0622, Made in France. ","5.7-oz. (35 servings) bottles: 10100230; 9.4-oz. (58 servings) bottles: 10119358, 10121489, 10121490, 24596401, 24596402, 24680101, and 24767601; and 18.7-oz. (115 servings) bottles: 24596701.",,"226,381 consumer units","The products are being recalled due to the receipt of a relatively high number of consumer complaints.",5/7/2013,"05/07/2013",10/9/2013,"10/09/2013"
"Food",65111,"Ongoing","Novartis Consumer Health","Lincoln","NE","US","Voluntary: Firm Initiated","Letter","Product was distributed nationwide and included military distribution. Foreign distribution was made to Panama and Belize.","F-1963-2013","Class II","Benefiber Fiber Supplement Plus Calcium, Orange Natural Flavor, Sugar Free, packaged in 10.76-oz (48 Servings) bottles, UPC 300670108489. Distributed by: Novartis Consumer Health, Inc., Parsippany, NJ 07054-0622. Made in France. ","10102129, 10102130, 10102131, 10104656, 10104657, 10104658, 10104659, 10107484, 10114954, 10124211, and 10125514 ",,"110,664/10.76-oz (48 Servings) bottles","The products are being recalled due to the receipt of a relatively high number of consumer complaints.",5/7/2013,"05/07/2013",10/9/2013,"10/09/2013"
"Food",65111,"Ongoing","Novartis Consumer Health","Lincoln","NE","US","Voluntary: Firm Initiated","Letter","Product was distributed nationwide and included military distribution. Foreign distribution was made to Panama and Belize.","F-1962-2013","Class II","Benefiber Fiber Drink Mix, Kiwi Strawberry, Sugar Free, packaged in 5.0-oz. boxes containing 24/0.21-oz. stick packs, UPC 300670106249. Distributed by: Novartis Consumer Health, Inc., Parsippany, NJ 07054-0622. Made in France. ","10114419, 10115003, 10118673, 10121091, 10121092, 10121093, 10121094, 10123826, 10125460, and 10125461 ",,"152,016/5.0-oz. (24-ct) boxes","The products are being recalled due to the receipt of a relatively high number of consumer complaints.",5/7/2013,"05/07/2013",10/9/2013,"10/09/2013"
"Food",65111,"Ongoing","Novartis Consumer Health","Lincoln","NE","US","Voluntary: Firm Initiated","Letter","Product was distributed nationwide and included military distribution. Foreign distribution was made to Panama and Belize.","F-1964-2013","Class II","Benefiber Non-Thickening Powder, Sugar Free, packaged in the following configurations: (1) 2.8-oz. (20 servings) bottles, UPC 300670044206; (2) 4.6-oz. (32 servings) bottles, UPC 300670044329; (3) 5.4-oz. (38 servings) bottles, UPC 300670044381; (4) 8.6-oz. (62 servings) bottles, UPC 300670044626; (5) 12.3-oz. (90 servings) bottles, UPC 300670044909; (6) 16.7-oz. (125 servings) bottles, UPC 300670044831; (7) 1.6-lb. (190 servings) bottles, UPC 300670044190; (8) 20.2-oz .(125+25=150 servings) bottles, UPC 300670174590; (9) 10.3-oz. (62+13=75 servings) bottles, UPC 300670175757; (10) Bulk .12-oz. (1 serving) stick pack, UPC 300679999996; (11) 3.45-oz. boxes containing 28/0.12-oz. stick packs, UPC 300670030285; and (12) 4.19-oz. boxes containing 28+6/0.12-oz. stick packs, UPC 300670030346. Distributed by: Novartis Consumer Health, Inc., Parsippany, NJ 07054-0622. Made in France.","2.8-oz. (20 servings) bottles: 10081233, 10084981, 10086954, 10087654, 10089097, 10090985, 10095687, 10095688, 10102413, 10102758, 10106405, 10107215, 10110117, 0112155, 10115504, 10119610, 10120346, 10123373, and 10124210; 4.6-oz. (32 servings) bottles: 10093120, 10099454, 10101273, 10102759, 10104643, 10107322, 10107334, 10109690, 10114152, and 10123951; 5.4-oz. (38 servings) bottles: 10079944, 10079945, 10084982, 10086957, 10087655, 10088811, 10089098, 10089099, 10090986, 10090987, 10095505, 10097339, 10101278, 10102700, 10104644, 10104645, 10104646, 10104647, 10107225, 10108800, 10112148, 10112149, 10116295, 10117967, 10118825, 10120029, 10120452, and 10122150; 8.6-oz. (62 servings) bottles: 10081004, 10081005, 10081006, 10081007, 10081008, 10081009, 10081010, 10081011, 10087657, 10087658, 10089129, 10089130, 10089131, 10090593, 10090992, 10090993, 10090998, 10090999, 10093121, 10094588, 10095506, 10099453, 10101280, 10102760, 10104648, 10104649, 10107227, 10107232, 10108547, 10108549, 10108550, 10112145, 10116296, 10117966, 10118824, 10120023, 10120341, 10120449, 10122151, and 10122152; 12.3-oz. (90 servings) bottles: 10081000, 10081001, 10081002, 10081003, 10084983, 10086955, 10086956, 10087662, 10087663, 10089133, 10089134, 10095507, 10097341, 10101281, 10109497, 10112175, 10115077, 10119609, 10120348, and 10122866; 16.7-oz. (125 servings) bottles: 10080810, 10081012, 10081013, 10081114, 10086958, 10087661, 10089135, 10089136, 10090988, 10090989, 10093124, 10095503, 10095510, 10102761, 10104650, 10104652, 10104654, 10107344, 10112146, 10112147, 10116297, 10117964, 10118823, 10120008, 10120345, 10120799, 10121700, 10122154, 10122956, and 10127499; 25.6-oz. (190 servings) bottles: 10081227, 10081228, 10081229, 10081230, 10081231, 10081232, 10084984, 10084985, 10084986, 10084987, 10084988, 10087659, 10087660, 10089137, 10089138, 10090994, 10090995, 10090996, 10095513, 10095514, 10102762, 10102763, 10104655, 10107381, 10108545, 10112153, 10113299, 10118822, 10120006, 10122129, 1",,"19,900,520 consumer units","The products are being recalled due to the receipt of a relatively high number of consumer complaints.",5/7/2013,"05/07/2013",10/9/2013,"10/09/2013"
"Food",65111,"Ongoing","Novartis Consumer Health","Lincoln","NE","US","Voluntary: Firm Initiated","Letter","Product was distributed nationwide and included military distribution. Foreign distribution was made to Panama and Belize.","F-1961-2013","Class II","Benefiber Fiber Drink Mix, Cherry Pomegranate, Sugar Free, packaged in 5.0-oz. boxes containing 24/0.21-oz. stick packs, UPC 300670107246. Distributed by: Novartis Consumer Health, Inc., Parsippany, NJ 07054-0622. Made in France. ","10116609, 10118436, 10121279, 10121280, 10122653, 10122654, 10125466, and 10128711 ",,"162,408/5.0-oz. (24-ct) boxes","The products are being recalled due to the receipt of a relatively high number of consumer complaints.",5/7/2013,"05/07/2013",10/9/2013,"10/09/2013"
"Food",65111,"Ongoing","Novartis Consumer Health","Lincoln","NE","US","Voluntary: Firm Initiated","Letter","Product was distributed nationwide and included military distribution. Foreign distribution was made to Panama and Belize.","F-1960-2013","Class II","Benefiber Plus Heart Health Non-Thickening Powder, Sugar Free, packaged in 6.4-oz (48 servings) bottles, UPC 300673002487. Distributed by: Novartis Consumer health, Inc., Parsippany, NJ 07054-0622. Made in France. ","10118915, 10118916, 10118917, 10118918, 10120338, 10120361, 10122590, 10122591, 10123950, 10126662, and 10127376 ",,"170,220/6.4-oz. (48 servings) bottles","The products are being recalled due to the receipt of a relatively high number of consumer complaints.",5/7/2013,"05/07/2013",10/9/2013,"10/09/2013"
"Devices",65112,"Ongoing","ConMed Corporation","Utica","NY","US","Voluntary: Firm Initiated","Letter","Worldwide distribution: USA (nationwide) and the country of: Saudi Arabia","Z-1317-2013","Class II","PadPro(R) Adult Radiotransparent Multifunction Electrodes, REF/Catalog No. 2001M-C. The PadPro(R) Adult Radiotransparent Multifunction Electrodes with Carbon Leadwires and Medtronic(R) Connector are intended to be used in external pacing, defibrillation and monitoring applications","Lot Code Y092012-21, Manufacture Date 10/10/2012; Lot Code Y102612-12, Manufacture Date 11/17/2012; Lot Code Y110912-20, Manufacture Date 11/30/2012; Lot Code Y112912-10, Manufacture Date 12/22/2012; Lot Code Y121312-19, Manufacture Date 01/03/2013; Lot Code Y011013-13, Manufacture Date 01/29/2013; Lot Code Y012513-02, Manufacture Date 02/12/2013; Lot Code Y020713-05, Manufacture Date 02/26/2013; Lot Code Y021413-03, Manufacture Date 03/07/2013; Lot Code Y030113-04, Manufacture Date 03/23/2013",,"Domestic: 49,010; Foreign: 600","ConMed was notified by the contract manufacturer that their wire/connector supplier reported damage to the connector tooling which could pinch or compress the lead wire filaments and potentially render the device incapable of delivering the appropriate energy or shock to the patient and/or could cause potential injury to user or patient. ",5/3/2013,"05/03/2013",5/22/2013,"05/22/2013"
"Devices",65113,"Ongoing","American Optisurgical Inc","Lake Forest","CA","US","Voluntary: Firm Initiated","Letter","Worldwide distribution, US, including the states of United States: Alabama, Arkansas, Arizona, California, Colorado, Florida, Georgia, Iowa, Illinois, Indiana, Kansas, Kentucky, Massachusetts, Maryland, Michigan, Minnesota, Missouri, North Carolina, Nebraska, New Jersey, New York, Ohio, Pennsylvania, South Carolina, Tennessee, Texas, Utah, Virginia, Washington Wisconsin, West Virginia and the countries of Singapore and the Philippines.","Z-1516-2013","Class II","American Optisurgical's TX1 Tissue Removal System Console. The console is a software unit that is indicated for use in surgical procedures. ","Serial#: 5510124 55400000 55400001 55400002 55400003 55400004 55400005 55400006 55400007 55400008 55400009 55400010 55400011 55400012 55400013 55400014 55400015 55400016 55400017 55400018 55400019 55400020 55400021 55400022 55400023 55400024 55400025 55400026 55400027 55400028 55400029 55400030 55400031 55400032 55400033 55400034 55400035 55400036 55400037 55400038 55400039 55400040 55400041 55400042 55400043 55400044 55400045 55400046 55400047 55400048 55400049 55400050 55400051 55400052 55400053 55400054 55400055 55400056 55400057 55400058 55400059 55400060 55400061 55400062 55400063 55400064 55400065 55400066 55400067 55400068 55400069 55400070 55400071 55400072 55400073 55400074 55400075 55400076 55400077 55400078 55400079 55400080 55400081 55400082 55400083 55400084 55400085 55400086 55400087 55400088 55400089 55400090 55400091 55400092 55400093 55400094 55400095 55400096 55400097 55400098 55400099 55400100 55400101 55400102 55400103 55400104 55400105 55400106 55400107 55400108 55400109 55400110 55400111 55400112 55400113 55400114 55400115 55400116 55400117 55400118 55400119 55400120 55400121 55400122 55400123 55400124 55400125 55400126 55400127 55400128 55400129 55400130 55400131 55400132 55400133 55400134 55400135 55400136 55400137 55400138 55400139 55400140 55400141 55400142 55400143 55400144 55400145 55400146 55400147 55400148 55400149 55400150 55400151 55400152 55400153 55400154 55400155 55400156 55400157 55400158 55400159 55400160 55400161 55400162 55400163 55400164 55400165 55400166 55400167 55400168 55400169 55400170 55400171 55400172 55400173 55400174 55400175 55400176 55400177 55400178 55400179 55400180 55400181 55400182 55400183 5",".","194 units","The recall has been initiated due to an overheating protection voltage suppressor on the redundant safety protection circuit board. Secondary to the recall, American Optisurgical, Inc. will be making a correction to add spacers between the valve and cassette to correct a small irrigation leak that can occur after the priming cycle. Use of this product may cause the device to lose power and stop working.",3/30/2013,"03/30/2013",6/12/2013,"06/12/2013"
"Biologics",65114,"Terminated","Community Blood Centers of South Florida, Inc.","Hialeah","FL","US","Voluntary: Firm Initiated","Letter","Switzerland","B-1880-13","Class III","Blood and Blood Products for Reprocessing","W036812339618; ",".","1","Blood product, collected from a donor whose suitability to donate was not adequately determined, was distributed.",4/4/2013,"04/04/2013",7/24/2013,"07/24/2013"
"Drugs",65115,"Ongoing","Mylan Institutional, Inc. (d.b.a. UDL Laboratories)","Rockford","IL","US","Voluntary: Firm Initiated","Letter","Nationwide","D-452-2013","Class III","Budesonide Capsules, 3 mg, Enteric Coated, packaged in 30-count capsules unit dose (3 x 10 capsules blister packaged) per box, Rx only, Manufactured by: Mylan Pharmaceuticals Inc., Morgantown, WV 26505; Packaged and Distributed by: UDL Laboratories, Inc., Rockford, IL 61103, NDC 51079-020-03. ","Lot No: 3037382, Exp 09/13",".","1,621 boxes","Failed Dissolution Specifications: Routine stability testing at the 12-month interval yielded an out-of-specification (OOS) result for dissolution testing.",5/15/2013,"05/15/2013",5/29/2013,"05/29/2013"
"Food",65116,"Ongoing","Galveston Shrimp Company, Inc.","Galveston","TX","US","Voluntary: Firm Initiated","Press Release","All product was distributed in Texas.","F-1843-2013","Class II","Texas Wild UPC, 10/15 BSO, Shrimp Headless Shell-on, IQF, Wild Caught, Product of USA, 20# Net Weight, Galveston Shrimp Co., Galveston, TX 77550","UPC 27241-45512 and 27241-45510 lot number 379B",".",,"Foreign Material",5/18/2013,"05/18/2013",8/28/2013,"08/28/2013"
"Food",65116,"Ongoing","Galveston Shrimp Company, Inc.","Galveston","TX","US","Voluntary: Firm Initiated","Press Release","All product was distributed in Texas.","F-1836-2013","Class II","Texas Wild UPC 51/60 BSO Shrimp Headless Shell-on IQF, Wild Caught, Product of the USA 20 # Net Weight, Galveston Shrimp Co., Galveston, TX 77550 ","UPC 27241-45551, lot number 379B",".",,"Foreign Material",5/18/2013,"05/18/2013",8/28/2013,"08/28/2013"
"Food",65116,"Ongoing","Galveston Shrimp Company, Inc.","Galveston","TX","US","Voluntary: Firm Initiated","Press Release","All product was distributed in Texas.","F-1837-2013","Class II","Texas Wild UPC 41/50 BSO, Shrimp Headless Shell-on, IQF Wild Caught, Product of the USA 20# Net Weight, Galveston Shrimp Co., Galveston, Texas 77550","UPC 27241-72010, lot number 379B",".",,"Foreign Material",5/18/2013,"05/18/2013",8/28/2013,"08/28/2013"
"Food",65116,"Ongoing","Galveston Shrimp Company, Inc.","Galveston","TX","US","Voluntary: Firm Initiated","Press Release","All product was distributed in Texas.","F-1844-2013","Class II","Texas Wild UPC, 10/15 WSO, Shrimp Headless Shell-on, IQF, Wild Caught, Product of USA, 20# Net Weight, Galveston Shrimp Co., Galveston, TX 77550","UPC 27241-45410 and 27241-45412 lot number H143",".",,"Foreign Material",5/18/2013,"05/18/2013",8/28/2013,"08/28/2013"
"Food",65116,"Ongoing","Galveston Shrimp Company, Inc.","Galveston","TX","US","Voluntary: Firm Initiated","Press Release","All product was distributed in Texas.","F-1839-2013","Class II","Texas Wild UPC, 26/30 BSO, Shrimp Headless Shell-on, IQF, Wild Caught, Product of USA, 20# Net Weight, Galveston Shrimp Co., Galveston, Texas 77550","UPC 27241-72005 lot number 379B",".",,"Foreign Material",5/18/2013,"05/18/2013",8/28/2013,"08/28/2013"
"Food",65116,"Ongoing","Galveston Shrimp Company, Inc.","Galveston","TX","US","Voluntary: Firm Initiated","Press Release","All product was distributed in Texas.","F-1841-2013","Class II","Texas Wild UPC, 16/20 BSO, Shrimp Headless Shell-on, IQF, Wild Caught, Product of USA, 20# Net Weight, Galveston Shrimp Co., Galveston, TX 77550","UPC 27241-45516 lot number 379B",".",,"Foreign Material",5/18/2013,"05/18/2013",8/28/2013,"08/28/2013"
"Food",65116,"Ongoing","Galveston Shrimp Company, Inc.","Galveston","TX","US","Voluntary: Firm Initiated","Press Release","All product was distributed in Texas.","F-1842-2013","Class II","Texas Wild UPC, 16/20 WSO, Shrimp Headless Shell-on, IQF, Wild Caught, Product of USA 20# Net Weight, Galveston Shrimp Co., Galveston, TX 77550","UPC 27241-45416 lot number H143",".",,"Foreign Material",5/18/2013,"05/18/2013",8/28/2013,"08/28/2013"
"Food",65116,"Ongoing","Galveston Shrimp Company, Inc.","Galveston","TX","US","Voluntary: Firm Initiated","Press Release","All product was distributed in Texas.","F-1840-2013","Class II","Texas Wild UPC 16/25 BSO, Shrimp Headless Shell-on, IQF, Wild Caught, Product of USA, 20# Net Weight, Galveston Shrimp Co., Galveston, TX 77550","UPC 27241-45519 lot number 379B",".",,"Foreign Material",5/18/2013,"05/18/2013",8/28/2013,"08/28/2013"
"Food",65116,"Ongoing","Galveston Shrimp Company, Inc.","Galveston","TX","US","Voluntary: Firm Initiated","Press Release","All product was distributed in Texas.","F-1838-2013","Class II","Texas Wild UPC 31/40 BSO, Shrimp Headless Shell-on, IQF, Wild Caught, Product of USA 20# Net Weight, Galveston Shrimp Co., Galveston, Texas 77550","UPC 27241-45530; 27241-45536 and 27241-45531 , lot number 379B",".",,"Foreign Material",5/18/2013,"05/18/2013",8/28/2013,"08/28/2013"
"Food",65117,"Ongoing","National Food & Beverage, Inc","Dallas","TX","US","Voluntary: Firm Initiated","Letter","FL, GA, and SC","F-1463-2013","Class III","Red Bone Alley Restaurant Wasabi All Natural Sauce for all Seafood & Chicken, Net Wt. 12 fl oz. Distributed by: Red Bone Alley Foods, LLC, 1903 W. Palmetto Street, Florence, SC 29501. Clear Plastic (Pet) Ring Neck Round bottle with neck band with white screw top cap. 6/12oz bottles= 1 case.","Lot Codes 060213, 0611130003, 072713007, 122713006, 012114001, and 040514003",".","3388 cases","Undeclared metabisulfite",5/6/2013,"05/06/2013",6/5/2013,"06/05/2013"
"Devices",65118,"Ongoing","Beckman Coulter Inc.","Brea","CA","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution-USA Nationwide and countries of: AU, CA, DE, ES, GB, IT, PT, and JP.","Z-1430-2013","Class II","AU2700 Clinical Chemistry Analyzer AU5400 Clinical Chemistry Analyzer Perform automated analysis of serum, urine, and other body fluids, including whole blood.","All Serial Numbers Model Numbers: AU2700, AU27000ISE, AU5421, AU5421ISE, AU5431. Part Numbers: E0750053 N3663400 N3663700 N3664000 N3664200 N3664400 N3664600 N3664800 N3878500 1465600 64270G E61DAU2700 N3663500 N3663600 N3663800 N3663900 N3664100 N3664300 N3664500 N3664700 N3664900 N3878600 O9102700 N3665000 N3665100 N3665200 N3665300 N3665400 N3878300 64542 A94504 N1683100 AU5431-U1 N3665500 N3665600 N3665700 N3665800 N3665900 N3878400 ",".","108 units","Beckman Coulter is recalling AU2700/AU2700 Plus & AU5400 Clinical Chemistry Analyzers becuase it was determined that the tubing/joint connections associated with these MODs may leak concentrated detergent. Beckman Coulter has received complaints that the joint connecting the tubing appears to disintegrate over time, causing a leak.",4/26/2013,"04/26/2013",6/5/2013,"06/05/2013"
"Devices",65119,"Ongoing","Angiodynamics, Inc.","Queensbury","NY","US","Voluntary: Firm Initiated","Letter","USA Nationwide Distribution including the states of: IL, GA, CA, NY OH, AZ, TX, NE, FL, PA, NC, WI, AL, IN, CO, MO, MT, NE, MA, VA, AK, IN, MI, NJ, MD, TN, CT, WA, MN","Z-1406-2013","Class II","AngioDynamics VenaCure EVLT NeverTouch-FRS PROCEDURE KIT under the following labeling: 1) Gold-Tipped Fiber 45cm Kit, Catalog Number: 11403301; 2) Gold-Tipped Fiber 65cm Kit, Catalog Number: 11403302; 3) Gold-Tipped Fiber 90cm Kit, Catalog Number: 11403304. Product Usage: This device is intended to be used to measure the refractive power and the radius of corneal curvature of the human eye. ","Corresponding Lot numbers: 1) 588948, 2) 588495 and 3)588480. Expiration date for these lot numbers: 12/2013.",".","Domestic Only: 1) 300 units, 2) 300 units, 3) 151 units.","AngioDynamics Inc., is recalling Micro Introducer Kits and VenaCure EVLT NeverTouch Procedure Kits, because the potential exists that the micro Introducer (sheath/dilator) packaged within the kit could be the wrong French size.",4/30/2013,"04/30/2013",6/5/2013,"06/05/2013"
"Devices",65119,"Ongoing","Angiodynamics, Inc.","Queensbury","NY","US","Voluntary: Firm Initiated","Letter","USA Nationwide Distribution including the states of: IL, GA, CA, NY OH, AZ, TX, NE, FL, PA, NC, WI, AL, IN, CO, MO, MT, NE, MA, VA, AK, IN, MI, NJ, MD, TN, CT, WA, MN","Z-1405-2013","Class II","AngioDynamics Micro Introducer Kits under the following labeling: 1) AngioDynamics 4F Standard Micro-Introducer Kit, Sterile, Catalog Number: 06597005, 2) AngioDynamics 5F Standard Micro-Introducer Kit, Sterile, Catalog number: 06597012; 3) AngioDynamics 4F Standard Micro-Introducer Kit, Sterile, Catalog Number: 06597013; 4) AngioDynamics 5F Standard Micro- Introducer Kit, Sterile, Catalog Number: 06597018; and 5) AngioDynamics 4F Standard Micro-Introducer Kit, Sterile, Catalog Number: 06597019. Product kits are individually wrapped in plastic, 10 units included per box. Product Usage: This device is intended to be used to measure the refractive power and the radius of corneal curvature of the human eye. ","Corresponding Lot numbers: 1) 588918 (Expiration date 01/2016), 2) 588927 (Expiration date 12/2015), 3) 588915 (Expiration date 01/2016), 4) 588913 (Expiration date 12/2015) and 5) 588930 (Expiration date 01/2016). ",".","Domestic(1,760 units): 1)260 units/26 boxes, 2)310 units/31 boxes,3)260 units/26 boxes,4)880 units/88 boxes,5)60 units/6 boxes,Foreign:10 units/1 box ","AngioDynamics Inc., is recalling Micro Introducer Kits and VenaCure EVLT NeverTouch Procedure Kits, because the potential exists that the micro Introducer (sheath/dilator) packaged within the kit could be the incorrect French size.",4/30/2013,"04/30/2013",6/5/2013,"06/05/2013"
"Devices",65120,"Ongoing","TZ Medical Inc.","Portland","OR","US","Voluntary: Firm Initiated","Telephone","Worldwide distribution - USA (nationwide) and Chile.","Z-1438-2013","Class II","adult defibrillation, cardioversion, pacing, monitoring Disposable Electrodes, Model P-211-M1 and P-214-M1. Product Usage: Used by trained professionals in hospitals, doctors offices, and Emergency Medical Services for adult low-energy defibrillation, transcutaneous pacing, cardioversion and monitoring. ","Model P-211-M1 Lot numbers: Y081712-17; Y081712-18; Y081712-19; Y081712-20; Y112612-08; Y112612-09; Y112612-10; Y112612-11; Y112612-12; Y112612-13; and Y020113-07. Model P-214-M1 Lot numbers: Y081712-04; Y112612-24; Y112612-23; and Y031913-10.",".","US: 10,410 pieces; Outside US: 100 pieces","TZ Medical Inc is recalling its P-211-M1 and P-214-M1 Medtronic / Physio Control Compatible transparent defibrillation electrodes because it may contain a defective white wire on the connector assembly. If a failure were to occur, the end user would be able to identify the failure by inspecting the white wire 1/4 inch from the Gray Medtronic / Physio adapter. The consignees will notice discoloration in the protective plastic jacket.",4/30/2013,"04/30/2013",6/5/2013,"06/05/2013"
"Biologics",65121,"Terminated","Eye Bank Of Wisconsin, Inc.","Madison","WI","US","Voluntary: Firm Initiated","Telephone","Wisconsin","B-1807-13","Class III","Cornea","CW101074OD; CW101074OS",,"2 corneas","Human Corneas, recovered from a donor whose donor eligibility determination was incomplete related to evaluating the donor's clinical evidence of infection due to relevant communicable disease agents and diseases, were distributed. ",5/7/2013,"05/07/2013",7/3/2013,"07/03/2013"
"Biologics",65122,"Terminated","American National Red Cross (the)","West Henrietta","NY","US","Voluntary: Firm Initiated","Telephone","Massachusetts","B-1879-13","Class II","Fresh Frozen Plasma","001KM82603 ",".","1","Blood product, collected from a donor whose suitability to donate was not adequately determined, was distributed.",3/22/2013,"03/22/2013",7/24/2013,"07/24/2013"
"Biologics",65123,"Terminated","Hoxworth Blood Center UC Medical Center","Cincinnati","OH","US","Voluntary: Firm Initiated","Letter","Ohio","B-1683-13","Class II","Red Blood Cells (Apheresis) Leukocytes Reduced","W037712052449; W037712052449; ",".","2","Blood products, collected from a donor who reported travel to a malarial endemic area, were distributed.",3/19/2013,"03/19/2013",7/24/2013,"07/24/2013"
"Biologics",65124,"Terminated","Bio-Rad Medical Diagnostics GmbH","Dreieich",,"DE","Voluntary: Firm Initiated","Letter","Multiple U.S. States","B-1808-13","Class III","Blood Grouping Reagent, Anti-S (Monoclonal)","813607001; 820312001",,"2 Units","Seraclone Anti-S, with a decreased reactivity in two lots numbers, was distributed. ",4/9/2013,"04/09/2013",7/3/2013,"07/03/2013"
"Drugs",65125,"Ongoing","THE COMPOUNDING SHOP, INC.","St Petersburg","FL","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Florida, California, Minnesota, and Maine","D-548-2013","Class II","Methotrexate 25mg/mL Injectable, 10 mL vials, Compounded by The Compounding Shop, St. Petersburg, FL","All Lots",".","19 vials of 10ml","Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes.",5/2/2013,"05/02/2013",6/12/2013,"06/12/2013"
"Drugs",65125,"Ongoing","THE COMPOUNDING SHOP, INC.","St Petersburg","FL","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Florida, California, Minnesota, and Maine","D-557-2013","Class II","Sodium EDTA 150 mg/mL Injectable, 250 mL vial, compounded by The Compounding Shop, St. Petersburg, FL","All Lots",".","43 vials of 250mL each","Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes",5/2/2013,"05/02/2013",6/12/2013,"06/12/2013"
"Drugs",65125,"Ongoing","THE COMPOUNDING SHOP, INC.","St Petersburg","FL","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Florida, California, Minnesota, and Maine","D-563-2013","Class II","Ascorbic Acid 500 mg/mL Injectable, 100 mL and 500 mL vials, compounded by The Compounding Shop, St. Petersburg, FL","All Lots",".","78 vials of 500ml and 92 vials of 100mL","Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes",5/2/2013,"05/02/2013",6/12/2013,"06/12/2013"
"Drugs",65125,"Ongoing","THE COMPOUNDING SHOP, INC.","St Petersburg","FL","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Florida, California, Minnesota, and Maine","D-568-2013","Class II","Morphine Sulfate 25 mg/mL Injectable, 40 mL vial, compounded by The Compounding Shop, St. Petersburg, FL","All Lots",".","1 vial of 40mL","Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes",5/2/2013,"05/02/2013",6/12/2013,"06/12/2013"
"Drugs",65125,"Ongoing","THE COMPOUNDING SHOP, INC.","St Petersburg","FL","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Florida, California, Minnesota, and Maine","D-559-2013","Class II","Lipoic Acid 25 mg/mL Injectable, 100 mL vials, compounded by The Compounding Shop, St. Petersburg, FL","All Lots",".","55 vials of 100mL","Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes",5/2/2013,"05/02/2013",6/12/2013,"06/12/2013"
"Drugs",65125,"Ongoing","THE COMPOUNDING SHOP, INC.","St Petersburg","FL","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Florida, California, Minnesota, and Maine","D-560-2013","Class II","Mitomycin 0.3 mg/mL Injectable, 10 mL vials, compounded by The Compounding Shop, St. Petersburg, FL","All Lots",".","4 vials of 10mL each","Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes",5/2/2013,"05/02/2013",6/12/2013,"06/12/2013"
"Drugs",65125,"Ongoing","THE COMPOUNDING SHOP, INC.","St Petersburg","FL","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Florida, California, Minnesota, and Maine","D-553-2013","Class II","Betamethasone 6 mg/mL Injectable, 5 mL vial, compounded by The Compounding Shop, St. Petersburg, FL","All Lots",".","20 vials of 5mL","Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes",5/2/2013,"05/02/2013",6/12/2013,"06/12/2013"
"Drugs",65125,"Ongoing","THE COMPOUNDING SHOP, INC.","St Petersburg","FL","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Florida, California, Minnesota, and Maine","D-552-2013","Class II","Baclofen/Bupivacaine 2,000 mcg/20 mg/mL Injectable, 45 mL vial, Compounded by The Compounding Shop, St. Petersburg, FL","All Lots",".","3 vials of 45mL","Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes",5/2/2013,"05/02/2013",6/12/2013,"06/12/2013"
"Drugs",65125,"Ongoing","THE COMPOUNDING SHOP, INC.","St Petersburg","FL","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Florida, California, Minnesota, and Maine","D-549-2013","Class II","Avastin 1.25 mg/0.05 mL Injectable, 4 mL vials, Compounded by The Compounding Shop, St. Petersburg, FL","All Lots",".","80 vials of 4mL each","Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes.",5/2/2013,"05/02/2013",6/12/2013,"06/12/2013"
"Drugs",65125,"Ongoing","THE COMPOUNDING SHOP, INC.","St Petersburg","FL","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Florida, California, Minnesota, and Maine","D-556-2013","Class II","Hydroxyprogesterone 250 mg/mL Injectable, 4 mL, 6 mL,8 mL and 10 mL vials, compounded by The Compounding Shop, St. Petersburg, FL","All Lots",".","12 vials of 4mL, 1 vial of 6 mL, 1 vial of 8 mLand 3 vials of 10mL","Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes",5/2/2013,"05/02/2013",6/12/2013,"06/12/2013"
"Drugs",65125,"Ongoing","THE COMPOUNDING SHOP, INC.","St Petersburg","FL","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Florida, California, Minnesota, and Maine","D-565-2013","Class II","Phosphatidyl Choline 10%, Injectable, 500 mL vial, compounded by The Compounding Shop, St. Petersburg, FL","All Lots",".","32 vials of 50mL","Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes",5/2/2013,"05/02/2013",6/12/2013,"06/12/2013"
"Drugs",65125,"Ongoing","THE COMPOUNDING SHOP, INC.","St Petersburg","FL","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Florida, California, Minnesota, and Maine","D-555-2013","Class II","Dexamethasone 10 mg/mL Injectable, 2 mL vial, compounded by The Compounding Shop, St. Petersburg, FL","All Lots",".","41 vials of 2mL","Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes",5/2/2013,"05/02/2013",6/12/2013,"06/12/2013"
"Drugs",65125,"Ongoing","THE COMPOUNDING SHOP, INC.","St Petersburg","FL","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Florida, California, Minnesota, and Maine","D-561-2013","Class II","Methylcobalamin 1,000 mcg/mL Injectable, 50 mL vials, compounded by The Compounding Shop, St. Petersburg, FL","All Lots",".","44 vials of 50mL each","Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes",5/2/2013,"05/02/2013",6/12/2013,"06/12/2013"
"Drugs",65125,"Ongoing","THE COMPOUNDING SHOP, INC.","St Petersburg","FL","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Florida, California, Minnesota, and Maine","D-558-2013","Class II","Glutathione 200 mg/mL Injectable, 50 mL vials, compounded by The Compounding Shop, St. Petersburg, FL","All Lots",".","7 vials of 50mL each","Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes",5/2/2013,"05/02/2013",6/12/2013,"06/12/2013"
"Drugs",65125,"Ongoing","THE COMPOUNDING SHOP, INC.","St Petersburg","FL","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Florida, California, Minnesota, and Maine","D-551-2013","Class II","Baclofen 1,000 mcg/mL Injectable, 20 mL and 40 mL vial, Compounded by The Compounding Shop, St. Petersburg, FL","All Lots",".","1 vial of 20mL and 1 vial of 40mL","Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes.",5/2/2013,"05/02/2013",6/12/2013,"06/12/2013"
"Drugs",65125,"Ongoing","THE COMPOUNDING SHOP, INC.","St Petersburg","FL","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Florida, California, Minnesota, and Maine","D-569-2013","Class II","Carnosine 5% Opth drop, 40 mL vial, compounded by The Compounding Shop, St. Petersburg, FL","All Lots",".","1 vial of 40ml","Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes",5/2/2013,"05/02/2013",6/12/2013,"06/12/2013"
"Drugs",65125,"Ongoing","THE COMPOUNDING SHOP, INC.","St Petersburg","FL","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Florida, California, Minnesota, and Maine","D-564-2013","Class II","B-Complex 100 mg/mL Injectable, 50 mL vials, compounded by The Compounding Shop, St. Petersburg, FL","All Lots",".","56 vials of 50mL","Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes",5/2/2013,"05/02/2013",6/12/2013,"06/12/2013"
"Drugs",65125,"Ongoing","THE COMPOUNDING SHOP, INC.","St Petersburg","FL","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Florida, California, Minnesota, and Maine","D-550-2013","Class II","Baclofen 500 mcg/mL Injectable, 22 mL vial, Compounded by The Compounding Shop, St. Petersburg, FL","All Lots",".","1 vial of 22mL","Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes.",5/2/2013,"05/02/2013",6/12/2013,"06/12/2013"
"Drugs",65125,"Ongoing","THE COMPOUNDING SHOP, INC.","St Petersburg","FL","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Florida, California, Minnesota, and Maine","D-572-2013","Class II","Tri-Mix Injections in 5 mL and 10 mL vials (Alprostadil, Phentolamine and Papaverine), compounded by The Compounding Shop, St. Petersburg, FL","All Lots",".","4 vials of 5mL and 22 vials of 10mL","Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes",5/2/2013,"05/02/2013",6/12/2013,"06/12/2013"
"Drugs",65125,"Ongoing","THE COMPOUNDING SHOP, INC.","St Petersburg","FL","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Florida, California, Minnesota, and Maine","D-554-2013","Class II","Dexpanthenol 200 mg/mL Injectable, 100 mL vial, compounded by The Compounding Shop, St. Petersburg, FL","All Lots",".","2 vials of 100mL","Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes",5/2/2013,"05/02/2013",6/12/2013,"06/12/2013"
"Drugs",65125,"Ongoing","THE COMPOUNDING SHOP, INC.","St Petersburg","FL","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Florida, California, Minnesota, and Maine","D-571-2013","Class II","MIC (Methionine, Inositol, and Choline) Injectable, 30 mL vials, compounded by The Compounding Shop, St. Petersburg, FL","All Lots",".","10 vials of 30 mL each","Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes",5/2/2013,"05/02/2013",6/12/2013,"06/12/2013"
"Drugs",65125,"Ongoing","THE COMPOUNDING SHOP, INC.","St Petersburg","FL","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Florida, California, Minnesota, and Maine","D-562-2013","Class II","Procaine 1% Injectable, 100 mL and 250 mL vials, compounded by The Compounding Shop, St. Petersburg, FL","All Lots",".","2 vials of 250mL and 26 vials of 100mL","Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes",5/2/2013,"05/02/2013",6/12/2013,"06/12/2013"
"Drugs",65125,"Ongoing","THE COMPOUNDING SHOP, INC.","St Petersburg","FL","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Florida, California, Minnesota, and Maine","D-566-2013","Class II","MIC (Methionine, Inositol, and Choline) + B12 25/50/50mg/1000mcg/mL Injectable, 30 mL vials, compounded by The Compounding Shop, St. Petersburg, FL ","All Lots",".","14 vials of 30mL each","Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes",5/2/2013,"05/02/2013",6/12/2013,"06/12/2013"
"Drugs",65125,"Ongoing","THE COMPOUNDING SHOP, INC.","St Petersburg","FL","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Florida, California, Minnesota, and Maine","D-570-2013","Class II","Praziquantel 56.8 mg, 50 mL vial, compounded by The Compounding Shop, St. Petersburg, FL","All Lots",".","5 vials of 50mL","Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes",5/2/2013,"05/02/2013",6/12/2013,"06/12/2013"
"Drugs",65125,"Ongoing","THE COMPOUNDING SHOP, INC.","St Petersburg","FL","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Florida, California, Minnesota, and Maine","D-567-2013","Class II","Testosterone Cypionate 200 mg/mL Injectable, 10 mL vials, compounded by The Compounding Shop, St. Petersburg, FL","All Lots",".","1 vial of 6mL, 19 vials of 10mL each and 1 vial of 40mL","Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes",5/2/2013,"05/02/2013",6/12/2013,"06/12/2013"
"Devices",65126,"Ongoing","Epocal","Ottawa","ON","CA","Voluntary: Firm Initiated","Letter","Worldwide Distribution-USA (nationwide) including the District of Columbia, US Virgin Islands and Puerto Rico, and the states of CA, CO, CT, FL, GA, IA, IL, IN, KS, KY, LA, MD, MI, MN, MS, NC, ND, NE, NH, NJ, NM, NY, OH, PA, RI, SC, SD, TN, TX, UT, VA, VE, WA, WI, and WV and the coutries of India, Argentina, Australia, Azerbaijan, Belarus, Canada, China, Colombia, Egypt, Germany, Guatemala, Israel, Japan, Malaysia, Mexico, Nepal, Netherlands, Peru, Philippines, Russia Fed., Singapore, South Africa, South korea, Thailand, and Vietnam.","Z-1971-2013","Class II","epoc BGEM Test Card (Catalogue number CT-1004-00-00). quantitative testing of samples for pH, pCO2, pO2, Sodium Potassium , Ionized Calcium, Glucose, Lactate and Hematocrit.","LOT #'s EXP. DATES 07-12283-00 03/26/2013 07-12284-00 03/27/2013 07-12285-00 03/28/2013 07-12289-00 04/01/2013 07-12290-00 04/02/2013 07-12292-00 04/04/2013 07-12293-00 04/05/2013 07-12296-00 04/08/2013 07-12297-00 04/09/2013 07-12298-00 04/10/2013 07-12300-00 04/12/2013 07-12303-00 04/15/2013 07-12305-00 04/17/2013 07-12306-00 04/18/2013 07-12307-00 04/19/2013 07-12310-00 04/22/2013 07-12312-00 04/24/2013 07-12313-00 04/25/2013 07-12314-00 04/26/2013 07-12317-00 04/29/2013 07-12320-00 05/02/2013 07-12321-00 05/03/2013 07-12324-00 05/06/2013 07-12325-00 05/07/2013 07-12327-00 05/09/2013 07-12331-00 05/13/2013 07-12333-00 05/15/2013 07-12335-00 05/17/2013 07-12338-00 05/20/2013 07-12340-00 05/22/2013 07-12341-00 05/23/2013 07-12345-00 05/27/2013 07-12346-00 05/28/2013 07-12347-00 05/29/2013 07-12349-00 05/31/2013 07-12352-00 06/03/2013 07-12354-00 06/05/2013 07-12355-00 06/06/2013 07-12362-00 06/13/2013 07-12363-00 06/14/2013 07-13002-00 06/19/2013 07-13003-00 06/20/2013 07-13004-00 06/21/2013 07-13007-00 06/24/2013 07-13008-00 06/25/2013 07-13009-00 06/26/2013 07-13010-00 06/27/2013 07-13014-00 07/01/2013 07-13015-00 07/02/2013 07-13017-00 07/04/2013 ",,"828,750 Test Card","This recall is being initiated because the affected lots of this product may yield results that are not consistent with stated precision performance criteria at concentration values at the high-end of the Glucose test sensor (>400 mg/dl). Specifically, after a period of storage of three (3) to four (4) months, the Glucose sensor may report low results at the high end of the measurement range. ",3/13/2013,"03/13/2013",8/21/2013,"08/21/2013"
"Food",65128,"Ongoing","Atlantic Pro Nutrients, Inc. dba XYMOGEN","Orlando","FL","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","AK, AL, AR, AZ, CA, CO, CT, DE, FL, GA, IA, IL IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, NC, NJ, NM, NY, OH, OK, PA, RI, SC, TN, TX, UT, VA, WA, WI, WV, WY, District of Columbia and Hawaii","F-1523-2013","Class I","XYMOGEN EP Exclusive Patented Dietary Supplement Artriphen Clinically Tested to Support Healthy Joint Function, 90 and 180 capsule bottles ","All SKUs",".","16,268 units","Undeclared Soy and Milk on the label.",5/1/2013,"05/01/2013",6/19/2013,"06/19/2013"
"Devices",65129,"Ongoing","Verathon, Inc.","Bothell","WA","US","Voluntary: Firm Initiated","Letter","Worldwide distribution: USA (nationwide) including states of : AK, AL, AZ, CA, CO, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV, WY, Washington DC, Guam, and countries of : Argentina, Australia, Brazil, Canada, China, Ecuador, France, Germany, Hong Kong, India, Indonesia, Italy, Japan, Japan, Malaysia, Panama, Peru, Philippines, Singapore, South Korea, Taiwan, Thailand, The Netherlands, United Kingdom, and Venezuela.","Z-1558-2013","Class I","GlideScope Video Laryngoscope (GVL) 3, 4, 5 and GlideScope (AVL) 2, 3, 4 and 5 reusable blades Product Usage: The GlideScope Video Laryngoscopes are intended for use by qualified medical professionals to obtain a clear, unobstructed view of the vocal cords for medical procedures. The GlideScope Video Laryngoscopes system should only be used by individuals who have been trained and authorized by a physician or the institution providing patient care. The device is not life sustaining or life supporting. The GlideScope AVL Video Monitor system has the same intended use as the GVL System. The difference between systems is that the AVL has a digital platform and the GVL an analog platform. ","Model, Part and Serial Numbers: Model # GVL 3, Part # 0574-0007, Serial # range MD112388 to MD121908; Model # GVL 4 Part # 0574-0001 Serial # range LG112759 to LG122582; Model # GVL 5 Part # 0574-0030 Serial # range XL111799 to XL121759; Model # AVL 2 Part # 0574-0118 Serial # range AC111500 to AC121604; Model # AVL 3 Part # 0574-0115 Serial # range AD111500 to AD121688; Model # AVL 4 Part # 0574-0116 Serial # range AE11150 to AE121778; and Model # AVL 5 Part # 0574-0117 Serial # range AF111500 to AF121666.",,"4784 units worldwide (3,381 in the US and 1403 international)","Verathon GlideScope Reusable GVL and AVL Blades are being recalled due to the potential risk of premature failure/breakage of the blade tip that may not be readily visible during routine inspection before or after intubation.",5/8/2013,"05/08/2013",6/26/2013,"06/26/2013"
"Drugs",65130,"Ongoing","Beamonstar Products","Queen Creek","AZ","US","Voluntary: Firm Initiated","E-Mail","US states nationwide and international.","D-929-2013","Class I","SexVoltz All Natural Herbal Supplement, packaged in 1 & 2 capsule blister packs and 4, 10 and 12 capsule bottles, Manufactured For: BeaMonstar Products, Queen Creek, AZ","All lots of product distributed and sold from January 2012 to May 7, 2013 SKUs: 626570609490, 827912089028, 626570617877, 626570615316, 626570623588",".","673,851 capsules","Marketed Without an Approved NDA/ANDA; products have been found to contain tadalafil, the active ingredient in an FDA approved product used to treat erectile dysfunction, making this product an unapproved drug",5/1/2013,"05/01/2013",9/11/2013,"09/11/2013"
"Drugs",65130,"Ongoing","Beamonstar Products","Queen Creek","AZ","US","Voluntary: Firm Initiated","E-Mail","US states nationwide and international.","D-930-2013","Class I","Velextra All-Natural Herbal Supplement, packaged in 1 & 2 capsule blister packs and 4, 10 & 12 capsule bottles, Manufactured For: BeaMonstar Products Queen Creek, AZ","All lots of product distributed and sold from January 2012 to May 7, 2013. SKUs: SKUs 626570613855, 626570619055, 626570617860, 626570617563",".","145,632 capsules","Marketed Without an Approved NDA/ANDA; products have been found to contain tadalafil, the active ingredient in an FDA approved product used to treat erectile dysfunction, making this product an unapproved drug",5/1/2013,"05/01/2013",9/11/2013,"09/11/2013"
"Food",65132,"Terminated","Whole Foods Market Group Inc.","Everett","MA","US","Voluntary: Firm Initiated","E-Mail","Maine, Massachusetts, Rhode Island, Connecticut, New York, New Jersey","F-1470-2013","Class I","Whole Foods Salad Curried Vegan Chick N , 1 lb plastic bags (bulk)","Sell By Date: 5/10/13",".","171 lbs","Undeclared allergen: soy",5/8/2013,"05/08/2013",6/12/2013,"06/12/2013"
"Food",65132,"Terminated","Whole Foods Market Group Inc.","Everett","MA","US","Voluntary: Firm Initiated","E-Mail","Maine, Massachusetts, Rhode Island, Connecticut, New York, New Jersey","F-1469-2013","Class I","Whole Foods Salad Chicken Curry , 1 lb plastic bag (bulk)","Sell By Date: 5/10/13",".","493 lbs","Undeclared allergen: egg",5/8/2013,"05/08/2013",6/12/2013,"06/12/2013"
"Devices",65133,"Ongoing","GE Healthcare, LLC","Waukesha","WI","US","Voluntary: Firm Initiated","Visit","Worldwide distribution: USA (nationwide) including DC and Puerto Rico and countries: ALBANIA, ALGERIA, ARGENTINA, AUSTRALIA, AUSTRIA, AZERBAIDJAN, BELARUS, BELGIUM, BOLIVIA, BOSNIA-HERZEGOVINA, BRAZIL, BULGARIA, CANADA, CHILE, CHINA, COLOMBIA, CROATIA, CYPRUS, CZECH REPUBLIC, DENMARK, DOMINICAN REPUBLIC, ECUADOR, EGYPT, FINLAND, FRANCE, GEORGIA, GERMANY, GREAT BRITAIN, GREECE, GUADELOUPE, GUATEMALA, GUYANA, HONDURAS, HONG KONG, HUNGARY, ICELAND, INDIA, INDONESIA, IRAN, IRELAND, ISRAEL, ITALY, JAPAN,JORDAN, KAZAKHSTAN, KENYA, KUWAIT, LATVIA, LEBANON, LIBYA, LITHUANIAN, LUXEMBOURG, MALAYSIA, MALTA, MARTINIQUE, MEXICO, MOROCCO, NETHERLANDS, NEW ZEALAND, NORWAY, PAKISTAN, PANAMA, PARAGUAY, PERU. PHILIPPINES, POLAND, PORTUGAL, REPUBLIC OF MACEDONIA, REUNION, ROMANIA, RUSSIA, SAUDI ARABIA, SINGAPORE, SLOVAK REPUBLIC, SLOVENIA, SOUTH AFRICA, SOUTH KOREA, SPAIN, SUDAN, SWEDEN, SWITZERLAND, SYRIA, TAIWAN, THAILAND, TUNISIA, TUR,EKY, UKRAINE, UNITED ARAB EMIRATES, URUGUAY, VENEZUELA, VIETNAM, YUGOSLAVIA, MALAWI, MAURITANIA, NIGERIA, UKRAINE, IVORY COST, OMAN, ZAMBIA, UZBEKISTAN, ESTONIA, IRAQ, and JAMAICA.","Z-1943-2013","Class II","SIGNA INFINITY MR SYSTEM WITH EXCITE TECHNOLOGY GE 3.0T SIGNA INFINITY TWINSPEED WITH EXCITE MR SYSTEM GE SIGNA 3.0T WITH EXCITE MR SYSTEM GE SIGNA EXCITE 1.5T MR SYSTEM GE SIGNA EXCITE 3.0T MR SYSTEM Signa HDx Signa HDxt Signa HDi Signa Vibrant GE 0.35T SIGNA OVATION WITH EXCITE MR SYSTEM (i.e. Signa Ovation 5 and Ovation HD) GE 1.5T SIGNA HDe MR SYSTEM GE 0.35T SIGNA OVATION WITH EXCITE MR SYSTEM GE 0.7T SIGNA OPENSPEED (4) WITH EXCITE MR SYSTEM GE 0.7T SIGNA OPENSPEED (5) WITH EXCITE MR SYSTEM The GE Signa Infinity line of products are whole body magnetic resonance scanners designed to support high resolution, high signal-to-noise ratio and short scan times. The Signa Infinity System is indicated for use as a diagnostic imaging device to produce transverse, sagittal, coronal and oblique images, spectroscopic images, and/or spectra, dynamic images of the internal structures and organs of the entire body, including but not limited to, head, neck, TMJ, spine, breast, heart, abdomen, pelvis, joints, prostate, blood vessels, and musculoskeletal regions of the body. The images produced by the Signa Infinity systems reflect the spatial distribution of protons (hydrogen nuclei) exhibiting magnetic resonance. These images and/or spectra when interpreted by a trained physician yield information that may assist in diagnosis. ","Ref. # 60808 ''Products: Signa Infinity MR System with EXCITE Technology, Signa EXCITE 1.5T and Signa EXCITE 3.0T, Signa 3T with EXCITE, Signa 3T Infinity with EXCITE, GE 1.5T AND 3.0T SIGNA HDX MR SYSTEM (Waukesha, WI) FMI 60808'' Mfg Lot or Serial # 00000298045MR6 00000237944MR4 00000278301MR7 00000257724MR5 00000029079MR2 00000280678MR4 00000286982MR4 00000283664MR1 00000263686MR8 00000238343MR8 00001011BD6649 00000105XF5011 00000263832MR8 00000256696MR6 00000284409MR0 00000265824MR3 00000284407MR4 00000252930MR3 00000301212MR7 00000277495MR8 00000238364MR4 00000230664MR5 00000262150MR6 00000275961MR1 00000231910MR1 00000284466MR0 00000276678MR0 00000006583YR9 00000262101MR9 00000283815MR9 00000268471MR0 00000028886MR2 00000297726MR2 00000277916MR3 00000290478MR7 00000247217MR3 00000245819MR8 00000284864MR6 00000287026MR9 00000238355MR2 00000265183MR4 00000266460MR5 00000251094MR9 00000266825MR9 00000265718MR7 00000289270MR1 00000288702MR4 00000286851MR1 00000281374MR9 000000HDMR2685 00000HDMR20256 00000236703MR5 00000297201MR6 00000234797MR9 00000265066MR1 00000278766MR1 00000255610MR8 00000280252MR8 00000281156MR0 00000011742YR4 00000011570YR9 00000279479MR0 00000009057YR1 00000284902MR4 00000287649MR7 00000239864MR2 00000235678MR0 00000241145MR2 00000255599MR3 00000028959MR7 00000235242MR5 00000257752MR6 00000256990MR3 00000275647MR6 00000246615MR9 00000300674MR9 00000011579YR0 00000286249MR8 00000279921MR1 00000011882YR8 00000262908MR7 00000271646MR2 00000290192MR4 00000254485MR6 00000259530MR4 00000288192MR8 00000245803MR2 00000246622MR5 00000278624MR2 00000261879MR1 00000937BD5ED5 00000301020MR4 00000289016MR8 00000229365MR2 00000232415MR0 00000256228MR8 00000264529MR9 00000298718MR8 00000284386MR0 00000276588MR1 00000242558MR5 00000253635MR7 00000256984MR6 00000287626MR6 00000280089MR4 00000256699MR0 00000260698MR6 00000262933MR5 00000272896MR2 00000272890MR5 00000237064MR1 00000005232YR4 00000233272MR4 00000299162MR8 00000229474MR2 00000248485MR5 00000268524MR6 00000237059MR1 00000285218MR4 00000011"," 00000287551MR6 00000011934YR7 00000260480MR9 00000287880MR9 00000300498MR3 00000283514MR8 00000292820MR8 00000274888MR7 00000284715MR0 00000289789MR0 00000265716MR1 00000286018MR7 00000011563YR4 00000027552MR4 00000286560MR8 00000297700MR7 00000281258MR4 2102 00000239242MR1 00000289627MR2 00000028654MR9 00000298428MR4 00000288097MR9 00000263974MR8 00000297383MR2 00000298011MR8 00000282689MR9 00000282863MR0 00000283818MR3 00000283821MR7 00000294118MR5 00000930BD5D3C 00000278102MR9 00000012003YR0 00000284391MR0 00000289042MR4 00000282683MR2 00000263968MR0 00000284563MR4 00000283523MR9 00000278817MR2 00000283175MR8 00000012224YR2 00000919BD5BAA 00000302523MR6 00000273524MR9 00000235675MR6 00000289332MR9 00000288431MR0 00000278559MR0 00000269061MR8 00000287623MR3 00000283027MR1 00000265000MR0 00000295789MR2 00000289218MR0 00000294737MR2 00000011591YR5 00000299882MR1 00000282794MR7 00000288245MR4 00000012385YR1 00001101XF50A4 00000289335MR2 00000280670MR1 00000286492MR4 00000288721MR4 00000288224MR9 00000275670MR8 00000011224YR3 00000249771MR7 00000289347MR7 00000262667MR9 00000232413MR5 00000283434MR9 00000287553MR2 00000282996MR8 00000283126MR1 00000286094MR8 00000295807MR2 00000008380YR8 00000294605MR1 00000283699MR7 00000277491MR7 00000299640MR3 00000282829MR1 00000299422MR6 00000276266MR4 00000011946YR1 00000285754MR8 00000286850MR3 00000286009MR6 00000286433MR8 00000012232YR5 00000283847MR2 00000286776MR0 00000287461MR8 00000263875MR7 00000288004MR5 00000266203MR9 00000025604MR9 00000295898MR1 00000298502MR6 00000287616MR7 00000292290MR4 00000011884YR4 00000283639MR3 00000230108MR3 00000011578YR2 00000235686MR3 00000288110MR0 00000008550YR6 00000238183MR8 00000251229MR1 00000279618MR3 00000286744MR8 00000289027MR5 00000285055MR0 00000010964YR5 00000301615MR1 00000294519MR4 00000289761MR9 00000298976MR2 00000298187MR6 00000240106MR5 00000275463MR8 00000281228MR7 00000300984MR2 00000236702MR7 00000230099MR4 00000288822MR0 00000272897MR0 00000281485MR3 00000277919MR7 00000235681MR4 00000011547YR7 00000261385MR9","7016 (2919 US; 4097 OUS)","Screen save images are included in wrong exam due to duplicate UID creation. This may cause a safety issue due to a potential patient data mismatch.While the issue has only been observed at one customer site on the Signa HDxT 1.5T system, internal investigation revealed that the issue also impacts multiple GE healthcare MR Systems.",11/21/2011,"11/21/2011",8/21/2013,"08/21/2013"
"Food",65134,"Ongoing","Talenti Gelato","Marietta","GA","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","IN","F-1464-2013","Class II","Talenti Roman Raspberry Sorbetto, 16fl oz, Crafted by Talenti, Marietta, GA 30062","UPC 1 86852 00082 2, Lot #10/19/2014 M2",".","420 cases (2260/16 fl oz units)","Undeclared Allergen, Pecans",5/3/2013,"05/03/2013",6/5/2013,"06/05/2013"
"Devices",65136,"Ongoing","RAYSEARCH LABORATORIES AB","Stockholm",,"SE","Voluntary: Firm Initiated","E-Mail","Worldwide Distribution - USA including Connecticut, Florida, Massachusetts, Missouri, New York, Ohio, and foreign distribution to(Canada, Italy, Australia, Germany, Netherlands, and Switzerland.","Z-1419-2013","Class II","RayStation Therapy Treatment Planning System, Model Numbers 2.0, 2.5, and 3.0; CLASSIFICATION NAME: System, Planning, Radiation Therapy Treatment. RayStation is a software system designed for treatment planning and analysis of radiation therapy. ","Software version and build numbers 2.0.0.15, 2.5.1.89, and 3.0.0.251 (to determine if the version used is affected, bring up the About box in the RayStation application and check the build number reported0.",".","Domestic: 70 units; Foreign: 27 units","Under some circumstances, imported CT, MR and PET images are offset from their true positions by one pixel in one or two directions. Users must be aware of this information to avoid incorrect dose calculations during treatment planning. ",2/15/2013,"02/15/2013",6/5/2013,"06/05/2013"
"Devices",65137,"Ongoing","Philips Medical Systems (Cleveland) Inc","Cleveland","OH","US","Voluntary: Firm Initiated","Letter","Nationwide Distribution-including the states of AR, AZ, DE, IN, KS, LA, MA, MN, MS, MT, NJ, NY, NY, OH, OR, PA, TN, TX, VT, WV, and WY.","Z-1588-2013","Class II","Brilliance CT 64, Ingenuity CT, Ingenuity Core, and Ingenuity Core128 scanners are whole body Computed Tomography X-ray systems. Produce cross-sectional images of the body by computer reconstruction of x-ray transmission.","The following codes are affected by this recall:System Code #728231, Serial #: 9654, 91003, 95130, 95157, 95504 System Code #728326, Serial #: 32000,300003,300004,300005,300010,300011,300012,300013, 300014,300015,300018, 300027,300041,300053,300054, 300059, 300066, 300070,300071, 300073, 300074, 30077, 300078, 300079, 300080,300082,300084,300086,300091,300092, 300095, 300101, 300102,300112, 300119, 300127, 300128, 300129, 300131, 300132, 310064, 320030 System Code #728321, Serial #: 310096, 310070 System Code #728323, Serial #: 320033",,"50 units","If the operator selects a patient name from the worklist using the mouse and then selects a different patient name using the keyboard (arrow keys then press enter) the patient name that populates the exam information page is the patient name selected with the mouse. Also, it is possible to begin a normal clinical scan while the anti-virus scan is running. However, if the user is running a bolus tracking scan, typical real time information is not displayed to the user. The consequence is the user may initiate the clinical scan either earlier or later than desired resulting in a mistimed bolus. And, if the operator is running a bolus tracking scan at the time the anti-virus is scheduled to run and the operator ignores or is not aware of the McAfee VirusScan Notification message displayed on the screen, typical real time information will not be displayed to the user. The consequence is the user may initiate the clinical scan either earlier or later than desired resulting in a mistimed bolus.",3/21/2013,"03/21/2013",7/3/2013,"07/03/2013"
"Devices",65138,"Ongoing","Steris Corporation","Mentor","OH","US","Voluntary: Firm Initiated","Letter","Nationwide Distribution including the states of AK, AZ, CA, CO, FL, IL, IN, KY, LA, MA, MD, ME, MI, MO, MS, NC, NE, NH, NY, OH, OK, OR, PA, SD, TN, TX, VA, WA, WI and WY.","Z-1596-2013","Class II","Quick Connect QLC1677E, QRC1699E, QPC1721E and QFC1683E. STERIS Corporation, Mentor, OH 44060 QLC1677E, QRC1699E, QPC1721E and QFC1683E contain processing instructions, a Quick Reference Wall Chart and a flow unit. The flow unit consists of a Quick Reference Card, tubing, tethers and adapters for connecting specified devices to Flexible Processing Trays/Containers.","LOT NUMBERS: QLC1677E: 1986157 - 2740157; QRC1699E: 1953884- 3376282 & QPC1721E/ QFC1683E: 3809423-Q001121.",,"QLC1677E: 38; QRC1699E: 128 & QPC1721E/QFC1683E: 0","During a routine label review, the firm identified four SYSTEM 1E Quick Connects that will be updated to reflect the removal of obsolete device models. This labeling review process also highlighted the opportunity to combine two existing quick connects into a single product while eliminating the obsolete models.",3/4/2013,"03/04/2013",7/3/2013,"07/03/2013"
"Devices",65139,"Ongoing","Philips Medical Systems (Cleveland) Inc","Cleveland","OH","US","Voluntary: Firm Initiated","Letter","USA Nationwide Distribution - including the states of: AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, NC, ND, NE, NJ, NM, NV, NY, OH, OK, OR, PA, PR, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV, WY.","Z-1646-2013","Class II","Computed Tomography X-ray systems Product Usage: The Brilliance CT 64, Ingenuity Core, and Ingenuity Core128 scanners are whole body Computed Tomography X-ray systems that are intended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission data taken at different angles and planes. This device may include signal analysis and display equipment, patient, and equipment supports, components and accessories.","The following system code numbers and associated serial numbers are affected by this recall: System Code #728231, Serial #: 4001, 4003, 4016, 4020, 9009, 9029, 9030, 9033, 9034, 9037, 9038, 9040, 9041, 9043, 9044, 9045, 9048, 9049, 9051, 9052, 9054, 9056, 9058, 9059, 9062, 9063, 9064, 9065, 9066, 9067, 9068, 9069, 9070, 9071, 9072, 9073, 9074, 9075, 9077, 9080, 9081, 9083, 9086, 9087, 9088, 9089, 9092, 9093, 9094, 9096, 9098, 9099, 9104, 9105, 9106, 9107, 9108, 9112, 9118, 9120, 9126, 9127, 9131, 9135, 9137, 9138, 9140, 9142, 9143, 9148, 9151, 9156, 9159, 9160, 9162, 9163, 9166, 9171, 9172, 9173, 9175, 9177, 9180, 9187, 9190, 9195, 9196, 9197, 9201, 9202, 9205, 9206, 9208, 9213, 9214, 9215, 9216, 9217, 9218, 9235, 9243, 9259, 9501, 9502, 9503, 9504, 9505, 9506, 9507, 9508, 9509, 9510, 9511, 9512, 9513, 9514, 9515, 9516, 9517, 9518, 9519, 9520, 9521, 9522, 9523, 9524, 9525, 9526, 9527, 9528, 9529, 9530, 9531, 9532, 9533, 9534, 9535, 9536, 9537, 9538, 9539, 9540, 9541, 9542, 9543, 9545, 9546, 9547, 9548, 9549, 9550, 9551, 9552, 9553, 9554, 9555, 9556, 9557, 9558, 9559, 9560, 9561, 9562, 9563, 9564, 9565, 9566, 9567, 9568, 9569, 9570, 9571, 9572, 9573, 9574, 9575, 9576, 9577, 9578, 9579, 9580, 9581, 9582, 9583, 9584, 9585, 9586, 9587, 9588, 9589, 9590, 9591, 9592, 9593, 9594, 9596, 9597, 9598, 9599, 9600, 9601, 9602, 9603, 9604, 9605, 9606, 9607, 9608, 9610, 9611, 9612, 9613, 9614, 9615, 9616, 9617, 9618, 9619, 9620, 9621, 9622, 9623, 9624, 9625, 9626, 9627, 9628, 9629, 9630, 9631, 9632, 9633, 9634, 9635, 9636, 9637, 9638, 9639, 9640, 9641, 9642, 9643, 9644, 9645, 9646, 9647, 9648, 9649, 9650, 9651, 9652, 9653, 9654, 9655, 9656, 9657, 9658, 9659, 9660, 9661, 9662, 9663, 9664, 9665, 9666, 9667, 9668, 9670, 9671, 9672, 9673, 9674, 9675, 9676, 9677, 9678, 9679, 9680, 9681, 9682, 9683, 9684, 9685, 9686, 9687, 9688, 9689, 9690, 9691, 9692, 9693, 9694, 9695, 9697, 9698, 9699, 9700, 9701, 9702, 9703, 9704, 9705, 9706, 9707, 9708, 9709, 9710, 9711, 9712, 9713, 9714, 9715, 9716, 9717, 9718, 9719, 9720, 9721, 9722, 9723, 9",".","2348 total units: 2182 Brilliance CT 64 units; 95 Ingenuity Core units; and 71 Ingenuity Core128 units. ","Philips Healthcare received reports from the field that certain Brilliance CT 64, Ingenuity Core, and Ingenuity Core128 systems running software versions 2.6.1 or 3.5.4 exhibited intermittent swirl-like ring artifacts that may appear on reconstructed images, which may impair the diagnostic quality of affected images.",4/15/2013,"04/15/2013",7/10/2013,"07/10/2013"
"Devices",65140,"Ongoing","Philips Medical Systems (Cleveland) Inc","Cleveland","OH","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution - USA including AK, AR, AZ, CA, CO, CT, DC, DE, FL, GA, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, NJ, NM, NV, NY, OH, OK, OR, PA, PR, SC, SD, TN, TX, VA, WA, WI, WV & WY. Internationally to Australia, Austria, Bahrain, Belgium, Brazil, Canada, China, Czech Republic, Denmark, Dominican Republic, Egypt, France, Germany, India, Indonesia, Iran, Italy, Japan, Japan, Korea, Lebanon, Lithuania, Malaysia, Mexico, Portugal, Russian Federation, Saudi Arabia, Singapore, Slovenia, South Africa, Spain, Syria, Thailand, Turkey, Taiwan, Ukraine, United Arab Emirates, United Kingdom, Venezuela & Viet Nam.","Z-1481-2013","Class II","BrightView SPECT gamma camera for Emission Computed Tomography, Philips Medical Systems, Cleveland, OH 44143 BrightView SPECT is a gamma camera designed for single or dual detector nuclear imaging accommodating a broad range of emission computed tomography Emission Computed Tomography (ECT) studies.","Model # 882480, Serial #'s: 400054,400381, 4000089, 4000090, 4000091, 4000093, 4000094, 4000095, 4000098, 4000099, 4000100, 4000102, 4000103, 4000104, 4000105, 4000106, 4000107, 4000108, 4000109, 4000110, 4000111, 4000112, 4000113, 4000114, 4000115, 4000116, 4000117, 4000118, 4000119, 4000120,4000121, 4000122, 4000123, 4000124, 4000125, 4000126, 4000127, 4000128, 4000129, 4000130, 4000132, 4000133, 4000135, 4000136, 4000137, 4000138, 4000139, 4000140, 4000141, 4000142, 4000143, 4000144, 4000145, 4000146, 4000148, 4000149, 4000151, 4000152, 4000153, 4000154, 4000155, 4000156, 4000157, 4000158, 4000159, 4000160, 4000161, 4000162, 4000164, 4000165, 4000166, 4000167, 4000168, 4000169, 4000170, 4000171, 4000173, 4000174, 4000175, 4000176, 4000177, 4000178, 4000179, 4000180, 4000181, 4000182, 4000183, 4000184, 4000185, 4000186, 4000187, 4000188, 4000189, 4000190, 4000191, 4000192, 4000193, 4000194, 4000195, 4000196, 4000197, 4000198, 4000200, 4000202, 4000203, 4000204, 4000205, 4000206, 4000207, 4000208, 4000209, 4000212, 4000214, 4000215, 4000216, 4000218, 4000219, 4000220, 4000221, 4000222, 4000223, 4000224, 4000225, 4000226, 4000227, 4000228, 4000229, 4000230, 4000231, 4000232, 4000233, 4000234, 4000235, 4000236, 4000237, 4000238, 4000239, 4000240, 4000241, 4000242, 4000243, 4000244, 4000245, 4000246, 4000247, 4000248, 4000249, 4000250, 4000251, 4000252, 4000253, 4000254, 4000255, 4000256, 4000257, 4000258, 4000259, 4000260, 4000261, 4000262, 4000263, 4000264, 4000265, 4000266, 4000267, 4000268, 4000269, 4000270, 4000271, 4000272, 4000273, 4000274, 4000275, 4000276, 4000277, 4000278,4000279, 4000280, 4000282, 4000283, 4000284, 4000285, 4000287, 4000289, 4000290, 4000291, 4000292, 4000293, 4000295, 4000296, 4000297, 4000298, 4000300, 4000301, 4000302, 4000303, 4000304, 4000305, 4000306, 4000307, 4000308, 4000309, 4000310, 4000311, 4000312, 4000313, 4000314, 4000315, 4000316, 4000317, 4000318, 4000319, 4000320, 4000321, 4000322, 4000323, 4000324, 4000325, 4000326, 4000327, 4000328, 4000329, 4000330, 4000331, 400033",".","505 units","Philips has received one report from the field that there was an unexpected motion of the detector due to a failure of the mechanical assembly. ",4/25/2013,"04/25/2013",6/12/2013,"06/12/2013"
"Devices",65141,"Ongoing","Ethicon Endo-Surgery Inc","Cincinnati","OH","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution - USA Nationwide to all fifty (50) states, and internationally including the following countries: ARGENTINA, ARGENTINA, BAHRAIN, BELGIUM, BRAZIL, CANADA, CHILE, CHINA, COLOMBIA, COSTA RICA, CYPRUS, ECUADOR, EGYPT, EL SALVADOR, GREECE, HONDURAS, INDIA, INDONESIA, ISRAEL, JAMAICA, JAPAN, JORDAN, KOREA, REPUBLIC OF, KUWAIT, LEBANON, MEXICO, NETHERLANDS ANTILLES, NICARAGUA, PAKISTAN, PANAMA, PARAGUAY, PERU, PHILIPPINES, PUERTO RICO, QATAR, RUSSIAN FEDERATION, SAUDI ARABIA, SINGAPORE, SLOVENIA, SOUTH AFRICA, TAIWAN, PROVINCE OF CHINA, THAILAND, TRINIDAD AND TOBAGO, TURKEY, UNITED ARAB EMIRATES, URUGUAY, VENEZUELA and YEMEN.","Z-1776-2013","Class II","LIGACLIP Endoscopic Rotating Multiple Clip Applier Convenience Kit (Flex Trays), 10mm M/L Product Usage: The LIGACLIP Endoscopic Rotating Multiple Clip Applier is a sterile, single patient use instrument designed to provide a means of ligation through ENDOPATH surgical trocars. The instrument delivers 20 titanium clips that individually advance after each firing. The shaft is made of a low glare material that minimizes reflective distortion. It is designed to rotate 360 in either direction. The rotating knob is located to allow for a one-handed technique. ","FNC40XL, 41, 2017-09 to 2018-01; FNC41XL, 41, 2016-12 to 2018-02; FNC41XLD, 41, 2016-12 to 2018-02; FNC42XL, 41, 2016-12 to 2018-02; FNC43XL, 41, 2016-12 to 2018-02; FNC43XLD, 41, 2017-02 to 2018-02; KBC17XL, 41, 2016-12 to 2018-2; KNC03XL, 41, 2017-02 to 2017-06; KNC03XL, 42, 2017-09 to 2017-10; KNC03XL, 43, 2017-10; KNC07XL, 41, 2017-01 to 017-05; KNC07XL, 42, 2017-09 to 2017-10; KNC09XL, 41, 2016-12 to 2018-03; KNC19XL, 41, 2017-02; KNC60XL, 41, 2016-2 2018-02; KNC61XL, 41, 2016-12 to 2018-02; TNC20XL, 41, 2017-02 to 2017-03; TNC20XL, 43, 2017-10; TNC36XL, 41, 2017-01 to 2018-03; TNC49XL, 41, 2016-12 to 2018-02; TNC69XL, 41, 2016-12 to 2017-05; TNC69XL, 43, 2017-10 to 2018-1; XCB51S, 41, 2017-01; XCB51S, 42, 2017-09 to 2017-10; XCB52S, 41, 2016-12 to 2018-02; XCB55S, 41, 2017-07; XCB55S, 42, 2017-09 to 2017-10; XCB57S, 41, 2016-12 to 2018-01; XCC50S, 41, 2016-12 to 2018-02; XCC51S, 41, 2016-12 to 2018-02; XCC53S, 41, 2016-12 to 2018-02; XCD50S, 41, 2016-12 to 2018-02; XCD51S, 41, 2016-12 to 2018-02; XCD52S, 41, 2016-12 to 2018-01; KNC35XL, 42, 2017-09 to 2017-10; XBB48B, 41, 2016-07 to 2017-01; XBB48B, 42, 2017-02 and XBB79S, 41, 2017-05 to 2017-06.",,"49,357","Ethicon Endo-Surgery is initiating a voluntary recall for LIGACLIP 10mm M/L Endoscopic Rotating Multiple Clip Applier (ER320) due to potential clip formation and feeding issues which may result in improper clip formation, vessel damage and/or insufficient occlusion of the vessel or other structure",4/12/2013,"04/12/2013",7/31/2013,"07/31/2013"
"Devices",65141,"Ongoing","Ethicon Endo-Surgery Inc","Cincinnati","OH","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution - USA Nationwide to all fifty (50) states, and internationally including the following countries: ARGENTINA, ARGENTINA, BAHRAIN, BELGIUM, BRAZIL, CANADA, CHILE, CHINA, COLOMBIA, COSTA RICA, CYPRUS, ECUADOR, EGYPT, EL SALVADOR, GREECE, HONDURAS, INDIA, INDONESIA, ISRAEL, JAMAICA, JAPAN, JORDAN, KOREA, REPUBLIC OF, KUWAIT, LEBANON, MEXICO, NETHERLANDS ANTILLES, NICARAGUA, PAKISTAN, PANAMA, PARAGUAY, PERU, PHILIPPINES, PUERTO RICO, QATAR, RUSSIAN FEDERATION, SAUDI ARABIA, SINGAPORE, SLOVENIA, SOUTH AFRICA, TAIWAN, PROVINCE OF CHINA, THAILAND, TRINIDAD AND TOBAGO, TURKEY, UNITED ARAB EMIRATES, URUGUAY, VENEZUELA and YEMEN.","Z-1775-2013","Class II","LIGACLIP Endoscopic Rotating Multiple Clip Applier (ER320), 10mm M/L Product Usage: The LIGACLIP Endoscopic Rotating Multiple Clip Applier is a sterile, single patient use instrument designed to provide a means of ligation through ENDOPATH surgical trocars. The instrument delivers 20 titanium clips that individually advance after each firing. The shaft is made of a low glare material that minimizes reflective distortion. It is designed to rotate 360 in either direction. The rotating knob is located to allow for a one-handed technique. ","H44Z7W, 37ER320, 01/03/12 to 11/15/16; J4A016, 37ER320, 01/05/12 to 12/15/16; J4A11G, 37ER320, 01/10/12 to 12/15/16; J4A124, 37ER320, 01/10/12 to 12/15/16; J4A145 37ER320, 01/11/12 to 12/15/16 J4A182, 37ER320, 01/13/12 to 12/15/16; J4A21T, 37ER320, 01/27/12 to 12/15/16; J4A28D, 37ER320, 01/19/12 to 12/15/16; J4A28U, 37ER320, 01/19/12 to 12/15/16; J4A335, 37ER320, 01/23/12 to 12/15/16; J4A38L, 37ER320, 01/25/12 to 12/15/16; J4A39D, 37ER320, 01/26/12 to 12/15/16; J4A406, 37ER320, 01/26/12 to 12/15/16; J4A40P, 37ER320, 02/07/12 to 12/15/16; J4A45T, 37ER320, 01/29/12 to 12/15/16; J4A461, 37ER320, 01/30/12 to 12/15/16; J4A46T, 37ER320, 01/30/12 to 12/15/16; J4A48U,), 37ER320, 02/02/12 to 12/15/16; J4A49L, 37ER320, 02/01/12 to 12/15/16; J4A525, 37ER320, 02/02/12 to 12/15/16; J4A535, 37ER320, 02/02/12 to 12/15/16; J4A559, 41XBB48B 02/02/12 to 07/15/16; J4A60K, 37ER320, 02/08/12 to 01/15/17; J4A60W, 37ER320, 02/08/12 to 01/15/17; J4A61Z, 37ER320, 02/08/12 to 01/15/17; J4A62E, 37ER320, 02/08/12 to 01/15/17; J4A62U, 37ER320, 02/09/12 to 01/15/17; J4A71W, 37ER320, 02/15/12 to 01/15/17; J4A729, 37ER320, 02/15/12 to 01/15/17; J4A73H, 37ER320, 02/15/12 to 01/15/17; J4A743, 37ER320, 02/16/12 to 01/15/17; J4A74T, 37ER320, 02/16/12 to 01/15/17; J4A755, 37ER320, 02/16/12 to 01/15/17; J4A75P, 37ER320, 02/16/12 to 01/15/17; J4A86E, 37ER320, 02/24/12 to 01/15/17; J4A871, 37ER320, 02/25/12 to 01/15/17; J4A87L, 37ER320, 02/25/12 to 01/15/17; J4A889, 37ER320, 02/25/12 to 01/15/17; J4A92X, 41XBB48B 02/28/12 to 08/15/16; J4A97H, 37ER320, 03/02/12 to 01/15/17; J4A98T, 37ER320, 03/02/12 to 01/15/17; J4A997, 37ER320, 03/03/12 to 01/15/17; J4A99V, 37ER320, 03/03/12 to 02/15/17; J4AAOM, 37ER320, 03/03/12 to 02/15/17; J4AA1H, 37ER320, 03/05/12 to 02/15/17; J4AA71, 37ER320, 03/07/12 to 02/15/17; J4AA7V, 37ER320, 03/08/12 to 02/15/17; J4AA84, 37ER320, 03/08/12 to 02/15/17; J4AA9D, 37ER320, 03/08/12 to 02/15/17; J4AC2X, 37ER320, 03/10/12 to 02/15/17; J4AD09, 37ER320, 03/15/12 to 02/15/17; J4AD1A, 37ER320, 03/15/12 to 02/15/17; J4AD2G, 37ER320, "," 42XCB51S, 11/15/12 to 10/15/17; J92V8M, 43TNC20XL, 11/15/12 to 10/15/17; J92V8N, 43TNC69XL, 11/16/12 to 10/15/17; J92WOT, 02CK017, , 11/15/12 to 12/31/99; J92W2E, 43TNC69XL, 11/21/12 to 10/15/17; J92W2F, 43TNC20XL, 11/16/12 to 10/15/17; J92W2G, 43KNC03XL, 11/16/12 to 10/15/17; J92X07, 42KNC07XL, 11/21/12 to 10/15/17; J92XOA, 41FNC41XL, 11/22/12 to 10/15/17; J92XOC, 41XCC50S, 11/22/12 to 10/15/17; J92XOZ, 41FNC41XL, 11/21/12 to 10/15/17; J92X3P, 02CK017, , 11/22/12 to 12/31/99; J92X8C, 02CK017, , 11/24/12 to 12/31/99; J92X8D, 42KNC35XL, 11/23/12 to 10/15/17; J92X8E, 42XCB55S, 11/23/12 to 10/15/17; J92X9R, 41FNC43XL, 11/23/12 to 10/15/17; J92X9T, 41FNC42XL, 11/23/12 to 10/15/17; J92Y2P, 41KBC17XL, 11/26/12 to 10/15/17; J92Y2R, 41XCC50S, 11/26/12 to 10/15/17; J92Y2T, 41KNC61XL, 11/26/12 to 10/15/17; J92Y2U, 41XCC51S, 11/26/12 to 10/15/17; J92Y6R, 41XCD51S, 11/27/12 to 10/15/17; J92Y71, 41XCC51S, 11/28/12 to 10/15/17; J92ZOJ, 41FNC43XLD, 11/28/12 to 10/15/17; J92ZOK, 41KNC09XL, 11/28/12 to 10/15/17; J92Z14, 41XCD52S, 11/28/12 to 10/15/17; J92Z3Z, 02CK017, , 11/28/12 to 12/31/99; J92Z4R, 41XCB57S, 11/29/12 to 10/15/17; J92Z4T, 42XCB55S, 11/29/12 to 10/15/17; J92Z4U, 41XCC53S, 11/29/12 to 10/15/17; J92Z92, 41FNC41XL, 11/30/12 to 10/15/17; J92Z93, 41XCD51S, 12/01/12 to 10/15/17; J9302F, 41FNC42XL, 12/03/12 to 10/15/17; J9302G, 41KBC17XL, 12/03/12 to 10/15/17; J9302H, 41FNC43XL, 12/03/12 to 10/15/17; J9303L, 41XCC50S, 12/03/12 to 10/15/17; J93105, 41XCD51S, 12/05/12 to 11/15/17; J9313T, 41XCD52S, 12/05/12 to 11/15/17; J9313Z, 41XCC51S, 12/05/12 to 11/15/17; J93140, 41XCD50S, 12/07/12 to 11/15/17; J93168, 41XCD51S, 12/07/12 to 11/15/17; J9316C, 41FNC43XL, 12/10/12 to 11/15/17; J9316D, 41FNC42XL, 12/10/12 to 11/15/17; J9318Z, 02CK017, , 12/07/12 to 12/31/99; J93231, 02CK017, , 12/10/12 to 12/31/99; J9324T, 41KBC17XL, 12/10/12 to 11/15/17; J9324U, 41FNC40XL, 12/10/12 to 11/15/17; J9324V, 41XCC50S, 12/11/12 to 11/15/17; J9325M, 41FNC41XL, 12/11/12 to 11/15/17; K4C03G, 37ER320, 01/04/13 12/15/17; K4C03N, 37ER320, 01/04/13","738,356","Ethicon Endo-Surgery is initiating a voluntary recall for LIGACLIP 10mm M/L Endoscopic Rotating Multiple Clip Applier (ER320) due to potential clip formation and feeding issues which may result in improper clip formation, vessel damage and/or insufficient occlusion of the vessel or other structure",4/12/2013,"04/12/2013",7/31/2013,"07/31/2013"
"Devices",65141,"Ongoing","Ethicon Endo-Surgery Inc","Cincinnati","OH","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution - USA Nationwide to all fifty (50) states, and internationally including the following countries: ARGENTINA, ARGENTINA, BAHRAIN, BELGIUM, BRAZIL, CANADA, CHILE, CHINA, COLOMBIA, COSTA RICA, CYPRUS, ECUADOR, EGYPT, EL SALVADOR, GREECE, HONDURAS, INDIA, INDONESIA, ISRAEL, JAMAICA, JAPAN, JORDAN, KOREA, REPUBLIC OF, KUWAIT, LEBANON, MEXICO, NETHERLANDS ANTILLES, NICARAGUA, PAKISTAN, PANAMA, PARAGUAY, PERU, PHILIPPINES, PUERTO RICO, QATAR, RUSSIAN FEDERATION, SAUDI ARABIA, SINGAPORE, SLOVENIA, SOUTH AFRICA, TAIWAN, PROVINCE OF CHINA, THAILAND, TRINIDAD AND TOBAGO, TURKEY, UNITED ARAB EMIRATES, URUGUAY, VENEZUELA and YEMEN.","Z-1777-2013","Class II","LIGACLIP Endoscopic Rotating Multiple Clip Applier (ER320), 10mm M/L, bulk non-sterile Product Usage: The LIGACLIP Endoscopic Rotating Multiple Clip Applier is a single patient use instrument designed to provide a means of ligation through ENDOPATH surgical trocars. The instrument delivers 20 titanium clips that individually advance after each firing. The shaft is made of a low glare material that minimizes reflective distortion. It is designed to rotate 360 in either direction. The rotating knob is located to allow for a one-handed technique. ","CK017, 02, 2016-11 to 2018-03",,"10,488","Ethicon Endo-Surgery is initiating a voluntary recall for LIGACLIP 10mm M/L Endoscopic Rotating Multiple Clip Applier (ER320) due to potential clip formation and feeding issues which may result in improper clip formation, vessel damage and/or insufficient occlusion of the vessel or other structure",4/12/2013,"04/12/2013",7/31/2013,"07/31/2013"
"Food",65142,"Ongoing","Dairy Fresh LLC","Winston Salem","NC","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","FL, GA KY, NC, OH, PA, SC, TN and WV.","F-1526-2013","Class I"," IGA Brand Vanilla & Chocolate Ice Cream, 1.75 Quart","UPC #4137046131, Plant Code 3783, Sell by dates: 06-08-13 07-19-13, 08-02-13, 08-13-13 and 08-27-13. ",".","10,050 cartons","Undeclared allergens: Almonds, Coconut, Soy Lecithin",5/8/2013,"05/08/2013",6/19/2013,"06/19/2013"
"Biologics",65143,"Terminated","Lifesouth Community Blood Centers - Montgomery Region","Montgomery","AL","US","Voluntary: Firm Initiated","FAX","Alabama","B-1881-13","Class II","Platelets Pheresis Leukocytes Reduced","W1151130719671; W1151130719671; W1151130719671; ",".","3","Blood products, with platelet counts below the specified minimum requirement, were distributed.",3/5/2013,"03/05/2013",7/24/2013,"07/24/2013"
"Biologics",65144,"Terminated","LifeServe Blood Center","Des Moines","IA","US","Voluntary: Firm Initiated","E-Mail","Switzerland","B-1682-13","Class II","Blood and Blood Products for Reprocessing","W037912159715; ",".","1","Blood product, collected from a donor considered to be at increased risk for variant Creutzfeldt-Jakob Disease (vCJD), was distributed. ",4/26/2013,"04/26/2013",7/24/2013,"07/24/2013"
"Biologics",65145,"Terminated","OneBlood / dba CBCF","Lauderhill","FL","US","Voluntary: Firm Initiated","Telephone","Florida; New York","B-1837-13","Class II","Red Blood Cells (Apheresis) Leukocytes Reduced","1163414",,"1 unit","Blood products, collected from an ineligible donor, were distributed. ",3/20/2013,"03/20/2013",7/3/2013,"07/03/2013"
"Biologics",65145,"Terminated","OneBlood / dba CBCF","Lauderhill","FL","US","Voluntary: Firm Initiated","Telephone","Florida; New York","B-1836-13","Class II","Red Blood Cells Leukocytes Reduced","W036813020316; W036813020316",,"2 units","Blood products, collected from an ineligible donor, were distributed. ",3/20/2013,"03/20/2013",7/3/2013,"07/03/2013"
"Biologics",65145,"Terminated","OneBlood / dba CBCF","Lauderhill","FL","US","Voluntary: Firm Initiated","Telephone","Florida; New York","B-1838-13","Class II","Fresh Frozen Plasma","1163414",,"1 unit","Blood products, collected from an ineligible donor, were distributed. ",3/20/2013,"03/20/2013",7/3/2013,"07/03/2013"
"Veterinary",65146,"Ongoing","Rural King Supply, Inc.","Mattoon","IL","US","Voluntary: Firm Initiated","Telephone","Nationwide (IL, IN, KY, MI, MO, OH, TN)","V-008-2014","Class I","Stutzman's Feed & Supply LLC; Yellow Shelled Deer Corn; 50 Lbs.; WARNING: Do not feed to animals producing milk or meat for food.","AMEL 2/26/2013",".","183 tons (approximately 7,320 bags)","The deer corn has high levels of aflatoxin.",4/29/2013,"04/29/2013",12/11/2013,"12/11/2013"
"Devices",65147,"Ongoing","Siemens Healthcare Diagnostics, Inc.","Newark","DE","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution: USA (nationwide) and internationally to Canada","Z-0433-2014","Class II","syngo(R) Lab Data Manager - Version VA11B and VA12A Systems Securely consolidates data from multiple lab instruments, the LIS and Siemens StreamLAB(R) Automation Solutions. It provides autoverification, integrated QC capabilities, browser-based connectivity supporting up to 25 concurrent users, remote services to help keep systems running optimally and also has audit trail capabilities.","Siemens Material Number 10800057 (Version VA11B) and 10803188 (Version VA12A)",".","262","Under certain conditions the system may not perform as intended, causing the release of results to the Laboratory Information System that should have been held for manual review due to auto-verification rules or the delay/omission of result transmission to the LIS.",5/10/2013,"05/10/2013",12/11/2013,"12/11/2013"
"Devices",65148,"Completed","SagaTech Electronics, Inc.","Calgary","AB","CA","Voluntary: Firm Initiated","E-Mail","Worldwide Distribution:US (nationwide) and countries of:Canada and Mexico.","Z-1725-2013","Class II","Finger Sensor for Remmers Recorder (Formerly SnoreSat Sleep recorder) To be used to gather heart rate and blood oxygen data during a sleep study.","Model: 1.1 Lot numbers: 13367 and 13710",".","152 units 77 devices from lot 13367 and 75 devices from lot 13710","The outer jacket is receding away from the black sensor prematurely.",5/8/2008,"05/08/2008",7/17/2013,"07/17/2013"
"Biologics",65149,"Ongoing","Fenwal Inc","Lake Zurich","IL","US","Voluntary: Firm Initiated","Letter","US Nationwide","B-1844-13","Class III","4R3329E CPD/ADSOL DBL WB RS-2000 W/FENWAL Express System/Sample Diversion SYS 500 mL PL146","FM12C13011",,"1 Unit","Blood-Pack Units, with missing labeling on the satellite bags, were distributed. ",4/29/2013,"04/29/2013",7/3/2013,"07/03/2013"
"Biologics",65149,"Ongoing","Fenwal Inc","Lake Zurich","IL","US","Voluntary: Firm Initiated","Letter","US Nationwide","B-1842-13","Class III","4R3307E CPD/DSOL DBL WB RS-2000 W/FENWAL Express System/Y-Sampling Site 500 mL PL146","FM12J04016",,"1 Unit","Blood-Pack Units, with missing labeling on the satellite bags, were distributed. ",4/29/2013,"04/29/2013",7/3/2013,"07/03/2013"
"Biologics",65149,"Ongoing","Fenwal Inc","Lake Zurich","IL","US","Voluntary: Firm Initiated","Letter","US Nationwide","B-1843-13","Class III","4R3325E CPD/ADSOL TPL WB RS-2000 W/FENWAL Express System/Sample Diversion SYS 500 mL PL146","FM11J28016, FM11L06018",,"2 Units","Blood-Pack Units, with missing labeling on the satellite bags, were distributed. ",4/29/2013,"04/29/2013",7/3/2013,"07/03/2013"
"Biologics",65149,"Ongoing","Fenwal Inc","Lake Zurich","IL","US","Voluntary: Firm Initiated","Letter","US Nationwide","B-1845-13","Class III","4R3340E CPD/ADSOL TPL WB RZ-2000 W/FENWAL Express System/Y-Sampling Site 500 mL PL146","FM12L19044",,"1 Unit","Blood-Pack Units, with missing labeling on the satellite bags, were distributed. ",4/29/2013,"04/29/2013",7/3/2013,"07/03/2013"
"Biologics",65149,"Ongoing","Fenwal Inc","Lake Zurich","IL","US","Voluntary: Firm Initiated","Letter","US Nationwide","B-1841-13","Class III","4R1583 ''CPD/ADSOL DBL Flex-Excel/Sample Diversion SYS/PL146/PL2209 500 mL''","FM11J31036, FM11J10022",,"2 Units","Blood-Pack Units, with missing labeling on the satellite bags, were distributed. ",4/29/2013,"04/29/2013",7/3/2013,"07/03/2013"
"Devices",65150,"Ongoing","Merit Medical Systems, Inc.","South Jordan","UT","US","Voluntary: Firm Initiated","Letter","USA Nationwide Distribution.","Z-1408-2013","Class II","Merit Medical PerfOrma Anglographic Catheter 5F Multipack Product Usage: Angiographic catheters are designed to be used for delivering radiopaque media to selected sites in the vascular system in conjunction with routine diagnostic procedures. ","Lot Numbers: 1662386, 1662390, 1662385, 1662387, 1662391 ",".","1,465","Merit Medical Systems is recalling various lots of Performa Cardiac Multipacks containing a JR4.0 catheter due to a slight variation in tip shape.",5/2/2013,"05/02/2013",6/5/2013,"06/05/2013"
"Food",65151,"Completed","Delhaize America (Hannaford Bros)","South Portland","ME","US","Voluntary: Firm Initiated","E-Mail","Maine, New Hampshire, Vermont, New York and Massachusetts.","F-1587-2013","Class I","Hannaford Gourmet Oatmeal Raisin Cookies (9 oz. package) UPC # 0004126872715 ","Sold at retail bakery through 5/6/13",".","2899- 9 oz cookies","Cookies may contain undeclared tree nuts",5/4/2013,"05/04/2013",7/10/2013,"07/10/2013"
"Food",65151,"Completed","Delhaize America (Hannaford Bros)","South Portland","ME","US","Voluntary: Firm Initiated","E-Mail","Maine, New Hampshire, Vermont, New York and Massachusetts.","F-1588-2013","Class I","Hanna ford Gourmet Cookie Platter (36 oz. package), Includes oatmeal raisin cookies UPC # 04126874662 ","Sold at retail bakery through 5/6/13","."," 154 platters (36 oz)","Cookies may contain undeclared tree nuts",5/4/2013,"05/04/2013",7/10/2013,"07/10/2013"
"Devices",65152,"Ongoing","Siemens Healthcare Diagnostics, Inc.","Newark","DE","US","Voluntary: Firm Initiated","Letter","Nationwide distribution: US including states of : AK, AL, AR, AZ, CA, CO, CT, DC, GA, GU, FL, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, PR, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV, and WY.","Z-1925-2013","Class II","Dimension(R) Mass Creatine Kinase MB Isozyme Calibrator (RC420) The Mass Creatine Kinase MB isozyme Calibrator is an in vitro diagnostic product intended to be used to calibrate the Creatine Kinase MB Isozyme method for the Dimension(R) clinical chemistry system with heterogeneous immunoassay module.","Product - MMB CAL, Catalog Number RC420, Siemens Material Number 10445023 with lot numbers 2GD053, 2KD024, and 3AD051.",".","7,470","Siemens Healthcare Diagnostics has received complaints that the lyophilized cake is not fully dissolved after the stated time in the MMB calibrator Instructions For Use (IFU). The frequency of this occurrence is low but if it occurs, gel-like clumps may be observed.",6/5/2013,"06/05/2013",8/14/2013,"08/14/2013"
"Food",65153,"Completed","Gruma Corp","IRVING","TX","US","Voluntary: Firm Initiated","E-Mail","TX","F-1405-2013","Class II","Senora Verde Taco Dinner Kit, 12ct, 9.75 oz (276g), 12 cartons per case.","DA OCT 29 13 A 09:37",,"132 cases were shipped and retrieved","The incorrect taco seasoning pouch, which contained wheat, was placed into the Senora Verde Taco Dinner Kit, which didn't declare wheat, so the product contained undeclared wheat.",5/3/2013,"05/03/2013",5/22/2013,"05/22/2013"
"Drugs",65154,"Ongoing","Lloyd Inc. of Iowa","Shenandoah","IA","US","Voluntary: Firm Initiated","Letter","The firm distributed the bulk product to Forest Laboratories, Inc, St. Louis, MO who repackaged the product into 100-tablet bottles and distribution was made to 75 customers Nationwide and Puerto Rico.","D-435-2013","Class II","Lloyd Thyro-Tab 0.075 mg., packaged in 150,000-tablet bulk drums (2/75,000-tablet bags/drum) for repackaging, RX. The firm name on the label is Lloyd Pharmaceutical, Shenandoah, IA.","Lot #: HC04712, Exp. Mar-13; HD08112, Exp. Apr-13; HE08112, HD11112, Exp May-13.",".","9,545,718 tablets","cGMP deviations; After quality review of stability failures in previous lots, there is insufficient data to determine that other lots are not affected.",4/1/2013,"04/01/2013",5/29/2013,"05/29/2013"
"Drugs",65154,"Ongoing","Lloyd Inc. of Iowa","Shenandoah","IA","US","Voluntary: Firm Initiated","Letter","The firm distributed the bulk product to Forest Laboratories, Inc, St. Louis, MO who repackaged the product into 100-tablet bottles and distribution was made to 75 customers Nationwide and Puerto Rico.","D-445-2013","Class II","Levothroid (levothyroxine sodium tablets, USP), 100 mcg, RX only, 100 tablets per bottle, Manufactured for Forest Pharmaceuticals, Inc, St. Louis, MO by Lloyd Pharmaceutical, Shenandoah, IA, NDC 0456-1323-01","Lot #: 1095184, 1095185, 1095186, 1095187, Exp Apr-13; 1096370, Exp May-13; 1097547, 1097588, 1097589, Exp Jul-13.",".","142,103 Bottles","cGMP deviations; After quality review of stability failures in previous lots, there is insufficient data to determine that other lots are not affected.",4/1/2013,"04/01/2013",5/29/2013,"05/29/2013"
"Drugs",65154,"Ongoing","Lloyd Inc. of Iowa","Shenandoah","IA","US","Voluntary: Firm Initiated","Letter","The firm distributed the bulk product to Forest Laboratories, Inc, St. Louis, MO who repackaged the product into 100-tablet bottles and distribution was made to 75 customers Nationwide and Puerto Rico.","D-451-2013","Class II","Levothroid (levothyroxine sodium tablets, USP), 200 mcg, RX only, 100 tablets per bottle. Manufactured for Forest Pharmaceuticals, Inc, St. Louis, MO by Lloyd Pharmaceutical, Shenandoah, IA, NDC 0456-1327-01","Lot #: 1095923, Exp May-13; 1097828, Exp Jul-13.",".","29,489 Bottles","cGMP deviations; After quality review of stability failures in previous lots, there is insufficient data to determine that other lots are not affected.",4/1/2013,"04/01/2013",5/29/2013,"05/29/2013"
"Drugs",65154,"Ongoing","Lloyd Inc. of Iowa","Shenandoah","IA","US","Voluntary: Firm Initiated","Letter","The firm distributed the bulk product to Forest Laboratories, Inc, St. Louis, MO who repackaged the product into 100-tablet bottles and distribution was made to 75 customers Nationwide and Puerto Rico.","D-436-2013","Class II","Levothroid (levothyroxine sodium tablets, USP), 88 mcg, RX only, 100 tablets per bottle, Manufactured for Forest Pharmaceuticals, Inc, St. Louis, MO by Lloyd Pharmaceutical, Shenandoah, IA, NDC 0456-1329-01","Lot #: 1098967, Exp. Mar-13.",".","12,156 Bottles","cGMP deviations; After quality review of stability failures in previous lots, there is insufficient data to determine that other lots are not affected.",4/1/2013,"04/01/2013",5/29/2013,"05/29/2013"
"Drugs",65154,"Ongoing","Lloyd Inc. of Iowa","Shenandoah","IA","US","Voluntary: Firm Initiated","Letter","The firm distributed the bulk product to Forest Laboratories, Inc, St. Louis, MO who repackaged the product into 100-tablet bottles and distribution was made to 75 customers Nationwide and Puerto Rico.","D-447-2013","Class II","Levothroid (levothyroxine sodium tablets, USP) , 125 mcg, RX only, 100 tablets per bottle, Manufactured for Forest Pharmaceuticals, Inc, St. Louis, MO by Lloyd Pharmaceutical, Shenandoah, IA, NDC 0456-1324-01","Lot #: 1095209,1095211, Exp Apr-13; 1097408, 1097731, 1097732, Exp Jul-13.",".","77,471 Bottles","cGMP deviations; After quality review of stability failures in previous lots, there is insufficient data to determine that other lots are not affected.",4/1/2013,"04/01/2013",5/29/2013,"05/29/2013"
"Drugs",65154,"Ongoing","Lloyd Inc. of Iowa","Shenandoah","IA","US","Voluntary: Firm Initiated","Letter","The firm distributed the bulk product to Forest Laboratories, Inc, St. Louis, MO who repackaged the product into 100-tablet bottles and distribution was made to 75 customers Nationwide and Puerto Rico.","D-450-2013","Class II","Levothroid (levothyroxine sodium tablets, USP), 175 mcg, RX only, 100 tablets per bottle, Manufactured for Forest Pharmaceuticals, Inc, St. Louis, MO by Lloyd Pharmaceutical, Shenandoah, IA, NDC 0456-1326-01","Lot #r: 1095922, Exp May-13; 1097735, Exp Jul-13; 1099892, Exp Oct-13.",".","32,345 Bottles","cGMP deviations; After quality review of stability failures in previous lots, there is insufficient data to determine that other lots are not affected.",4/1/2013,"04/01/2013",5/29/2013,"05/29/2013"
"Drugs",65154,"Ongoing","Lloyd Inc. of Iowa","Shenandoah","IA","US","Voluntary: Firm Initiated","Letter","The firm distributed the bulk product to Forest Laboratories, Inc, St. Louis, MO who repackaged the product into 100-tablet bottles and distribution was made to 75 customers Nationwide and Puerto Rico.","D-437-2013","Class II","Lloyd Thyro-Tab 0.088 mg., packaged in 150,000-tablet bulk drums (2/75,000-tablet bags/drum) for repackaging, RX. The firm name on the label is Lloyd Pharmaceutical, Shenandoah, IA.","Lot #: HD04712, Exp. Mar-13; HF08112, Exp Apr-13; HF11112, Exp May-13.",".","5,767,711 tablets","cGMP deviations; After quality review of stability failures in previous lots, there is insufficient data to determine that other lots are not affected.",4/1/2013,"04/01/2013",5/29/2013,"05/29/2013"
"Drugs",65154,"Ongoing","Lloyd Inc. of Iowa","Shenandoah","IA","US","Voluntary: Firm Initiated","Letter","The firm distributed the bulk product to Forest Laboratories, Inc, St. Louis, MO who repackaged the product into 100-tablet bottles and distribution was made to 75 customers Nationwide and Puerto Rico.","D-440-2013","Class II","Lloyd Thyro-Tab 0.125 mg., packaged in 150,000-tablet bulk drums (2/75,000-tablet bags/drum) for repackaging, RX. The firm name on the label is Lloyd Pharmaceutical, Shenandoah, IA.","Lot #: HA27811, HC27811, Exp Apr-13; HD35311, HA00512, HB00512, exp Jul-13; HA04412, Exp Aug-13; HD06212, Exp Sep-13.",".","13,460,920 tablets","cGMP deviations; After quality review of stability failures in previous lots, there is insufficient data to determine that other lots are not affected.",4/1/2013,"04/01/2013",5/29/2013,"05/29/2013"
"Drugs",65154,"Ongoing","Lloyd Inc. of Iowa","Shenandoah","IA","US","Voluntary: Firm Initiated","Letter","The firm distributed the bulk product to Forest Laboratories, Inc, St. Louis, MO who repackaged the product into 100-tablet bottles and distribution was made to 75 customers Nationwide and Puerto Rico.","D-444-2013","Class II","Lloyd Thyro-Tab 0.200 mg., packaged in 150,000-tablet bulk drums (2/75,000-tablet bags/drum) for repackaging, RX. The firm name on the label is Lloyd Pharmaceutical, Shenandoah, IA.","Lot #: HD29411, Exp May-13; HE00512, Exp Jul-13; HF062122, Exp Sep-13.",".","5,771,989 tablets","cGMP deviations; After quality review of stability failures in previous lots, there is insufficient data to determine that other lots are not affected.",4/1/2013,"04/01/2013",5/29/2013,"05/29/2013"
"Drugs",65154,"Ongoing","Lloyd Inc. of Iowa","Shenandoah","IA","US","Voluntary: Firm Initiated","Letter","The firm distributed the bulk product to Forest Laboratories, Inc, St. Louis, MO who repackaged the product into 100-tablet bottles and distribution was made to 75 customers Nationwide and Puerto Rico.","D-434-2013","Class II","Levothroid (levothyroxine sodium tablets, USP) , 75 mcg, RX only, 100 tablets per bottle, Manufactured for Forest Pharmaceuticals, Inc, St. Louis, MO by Lloyd Pharmaceutical, Shenandoah, IA, NDC 0456-1322-01","Lot #: 1098752, Exp. Mar-13; 1099890, Exp Apr-13.",".","19,787 Bottles","cGMP deviations; After quality review of stability failures in previous lots, there is insufficient data to determine that other lots are not affected.",4/1/2013,"04/01/2013",5/29/2013,"05/29/2013"
"Drugs",65154,"Ongoing","Lloyd Inc. of Iowa","Shenandoah","IA","US","Voluntary: Firm Initiated","Letter","The firm distributed the bulk product to Forest Laboratories, Inc, St. Louis, MO who repackaged the product into 100-tablet bottles and distribution was made to 75 customers Nationwide and Puerto Rico.","D-443-2013","Class II","Lloyd Thyro-Tab 0.175 mg., packaged in 150,000-tablet bulk drums (2/75,000-tablet bags/drum) for repackaging, RX. The firm name on the label is Lloyd Pharmaceutical, Shenandoah, IA.","Lot #: HC29411, Exp May-13; HD00512, Exp Jul-13; HA08912, Exp Oct-13.",".","5,768,782 tablets","cGMP deviations; After quality review of stability failures in previous lots, there is insufficient data to determine that other lots are not affected.",4/1/2013,"04/01/2013",5/29/2013,"05/29/2013"
"Drugs",65154,"Ongoing","Lloyd Inc. of Iowa","Shenandoah","IA","US","Voluntary: Firm Initiated","Letter","The firm distributed the bulk product to Forest Laboratories, Inc, St. Louis, MO who repackaged the product into 100-tablet bottles and distribution was made to 75 customers Nationwide and Puerto Rico.","D-432-2013","Class II","Levothroid (levothyroxine sodium tablets, USP) , 50 mcg, RX only, 100 tablets per bottle, Manufactured for Forest Pharmaceuticals, Inc, St. Louis, MO by Lloyd Pharmaceutical, Shenandoah, IA, NDC 0456-1321-01","Lot #: 1098751, Exp. Mar-13",".","4,440 Bottles","cGMP deviations; After quality review of stability failures in previous lots, there is insufficient data to determine that other lots are not affected.",4/1/2013,"04/01/2013",5/29/2013,"05/29/2013"
"Drugs",65154,"Ongoing","Lloyd Inc. of Iowa","Shenandoah","IA","US","Voluntary: Firm Initiated","Letter","The firm distributed the bulk product to Forest Laboratories, Inc, St. Louis, MO who repackaged the product into 100-tablet bottles and distribution was made to 75 customers Nationwide and Puerto Rico.","D-438-2013","Class II","Lloyd Thyro-Tab 0.100 mg., packaged in 150,000-tablet bulk drums (2/75,000-tablet bags/drum) for repackaging, RX. The firm name on the label is Lloyd Pharmaceutical, Shenandoah, IA.","Lot #: HA27211, HB27211, HC27211, HD27211, Exp Apr-13; HB31411, Exp May-13; HD35511, HA35511, HB35511, HC35511, Exp Jul-13; HA06212, HB06212, Exp Sep-13.",".","21,019,909 tablets","cGMP deviations; After quality review of stability failures in previous lots, there is insufficient data to determine that other lots are not affected.",4/1/2013,"04/01/2013",5/29/2013,"05/29/2013"
"Drugs",65154,"Ongoing","Lloyd Inc. of Iowa","Shenandoah","IA","US","Voluntary: Firm Initiated","Letter","The firm distributed the bulk product to Forest Laboratories, Inc, St. Louis, MO who repackaged the product into 100-tablet bottles and distribution was made to 75 customers Nationwide and Puerto Rico.","D-448-2013","Class II","Levothroid (levothyroxine sodium tablets, USP), 137 mcg, RX only, 100 tablets per bottle, Manufactured for Forest Pharmaceuticals, Inc, St. Louis, MO by Lloyd Pharmaceutical, Shenandoah, IA, NDC 0456-1331-01.","Lot #: 1096372, Exp May-13.",".","12,911 Bottles","cGMP deviations; After quality review of stability failures in previous lots, there is insufficient data to determine that other lots are not affected.",4/1/2013,"04/01/2013",5/29/2013,"05/29/2013"
"Drugs",65154,"Ongoing","Lloyd Inc. of Iowa","Shenandoah","IA","US","Voluntary: Firm Initiated","Letter","The firm distributed the bulk product to Forest Laboratories, Inc, St. Louis, MO who repackaged the product into 100-tablet bottles and distribution was made to 75 customers Nationwide and Puerto Rico.","D-439-2013","Class II","Lloyd Thyro-Tab 0.112 mg., packaged in 150,000-tablet bulk drums (2/75,000-tablet bags/drum) for repackaging, RX. The firm name on the label is Lloyd Pharmaceutical, Shenandoah, IA.","Lot #: HE27211, Exp Apr-13; HE35511, Exp Jul-13; HA04112, Exp Aug-13; HC06212, Exp Sep-12.",".","7,614,709 tablets","cGMP deviations; After quality review of stability failures in previous lots, there is insufficient data to determine that other lots are not affected.",4/1/2013,"04/01/2013",5/29/2013,"05/29/2013"
"Drugs",65154,"Ongoing","Lloyd Inc. of Iowa","Shenandoah","IA","US","Voluntary: Firm Initiated","Letter","The firm distributed the bulk product to Forest Laboratories, Inc, St. Louis, MO who repackaged the product into 100-tablet bottles and distribution was made to 75 customers Nationwide and Puerto Rico.","D-446-2013","Class II","Levothroid (levothyroxine sodium tablets, USP), 112 mcg, RX only, 100 tablets per bottle, Manufactured for Forest Pharmaceuticals, Inc, St. Louis, MO by Lloyd Pharmaceutical, Shenandoah, IA, NDC 0456-1330-01","Lot #: 1095208, Exp Apr-13; 1097177, Exp Jul-13; 1098537 , Exp Aug-13.",".","40,311 Bottles","cGMP deviations; After quality review of stability failures in previous lots, there is insufficient data to determine that other lots are not affected.",4/1/2013,"04/01/2013",5/29/2013,"05/29/2013"
"Drugs",65154,"Ongoing","Lloyd Inc. of Iowa","Shenandoah","IA","US","Voluntary: Firm Initiated","Letter","The firm distributed the bulk product to Forest Laboratories, Inc, St. Louis, MO who repackaged the product into 100-tablet bottles and distribution was made to 75 customers Nationwide and Puerto Rico.","D-449-2013","Class II","Levothroid (levothyroxine sodium tablets, USP), 150 mcg, RX only, 100 tablets per bottle, Manufactured for Forest Pharmaceuticals, Inc, St. Louis, MO by Lloyd Pharmaceutical, Shenandoah, IA, NDC 0456-1325-01.","Lot #: 1095213, 1095214, Exp Apr-13; 1097733, Exp Jul-13; 1098540, Exp Aug-13.",".","61,347 Bottles","cGMP deviations; After quality review of stability failures in previous lots, there is insufficient data to determine that other lots are not affected.",4/1/2013,"04/01/2013",5/29/2013,"05/29/2013"
"Drugs",65154,"Ongoing","Lloyd Inc. of Iowa","Shenandoah","IA","US","Voluntary: Firm Initiated","Letter","The firm distributed the bulk product to Forest Laboratories, Inc, St. Louis, MO who repackaged the product into 100-tablet bottles and distribution was made to 75 customers Nationwide and Puerto Rico.","D-441-2013","Class II","Lloyd Thyro-Tab 0.137 mg., packaged in 150,000-tablet bulk drums (2/75,000-tablet bags/drum) for repackaging, RX. The firm name on the label is Lloyd Pharmaceutical, Shenandoah, IA.","Lot #: HD31411, Exp May-13; HC04112, Exp Aug-13.",".","3,844,402 tablets","cGMP deviations; After quality review of stability failures in previous lots, there is insufficient data to determine that other lots are not affected.",4/1/2013,"04/01/2013",5/29/2013,"05/29/2013"
"Drugs",65154,"Ongoing","Lloyd Inc. of Iowa","Shenandoah","IA","US","Voluntary: Firm Initiated","Letter","The firm distributed the bulk product to Forest Laboratories, Inc, St. Louis, MO who repackaged the product into 100-tablet bottles and distribution was made to 75 customers Nationwide and Puerto Rico.","D-442-2013","Class II","Lloyd Thyro-Tab 0.150 mg., packaged in 150,000-tablet bulk drums (2/75,000-tablet bags/drum) for repackaging, RX. The firm name on the label is Lloyd Pharmaceutical, Shenandoah, IA.","Lot #: HE27811, HD27811, Exp Apr-13; HC00512, Exp Jul-13; HD04112, HE06212, Exp Sep-13.",".","9,575,108 tablets","cGMP deviations; After quality review of stability failures in previous lots, there is insufficient data to determine that other lots are not affected.",4/1/2013,"04/01/2013",5/29/2013,"05/29/2013"
"Drugs",65154,"Ongoing","Lloyd Inc. of Iowa","Shenandoah","IA","US","Voluntary: Firm Initiated","Letter","The firm distributed the bulk product to Forest Laboratories, Inc, St. Louis, MO who repackaged the product into 100-tablet bottles and distribution was made to 75 customers Nationwide and Puerto Rico.","D-433-2013","Class II","Lloyd Thyro-Tab 0.050 mg., packaged in 150,000-tablet bulk drums (2/75,000-tablet bags/drum) for repackaging, RX. The firm name on the label is Lloyd Pharmaceutical, Shenandoah, IA.","Lot #: HB04712, Exp. Mar-13, HB08112, HC08112, Exp Apr-13, and HC11112 May-13.",".","7,681,277 tablets","cGMP deviations; After quality review of stability failures in previous lots, there is insufficient data to determine that other lots are not affected.",4/1/2013,"04/01/2013",5/29/2013,"05/29/2013"
"Biologics",65155,"Terminated","Oklahoma Blood Institute - Sylvan N Goldman Center","Oklahoma City","OK","US","Voluntary: Firm Initiated","FAX","Oklahoma","B-1883-13","Class II","Platelets Pheresis Leukocytes Reduced","W091013118069; W091013118069; W091013118069; ",".","3","Blood products, labeled leukoreduced without the assurance they met the criteria for leukoreduced products, were distributed.",4/26/2013,"04/26/2013",7/24/2013,"07/24/2013"
"Biologics",65156,"Completed","OneBlood, Inc. dba Southeastern Comm. Blood Center","Tallahassee","FL","US","Voluntary: Firm Initiated","FAX","Florida; Georgia","B-1939-13","Class II","Red Blood Cells Leukocytes Reduced","W12701380967900; W12701380967700; W12701380968200; W12701380950700; W12701380953600; W12701380953400; W12701380953300; W12701380953700; W12701380953800; W12701381096600; W12701381096400; W12701380957500; W12701380705400; W12701380706400; W12701380706000; W12701380705100; W12701380706600; W12701380706100; W12701380707000; W12701380707400; W12701381054200; W12701381052100; W12701381053700; W12701381055400; W12701381052600; W12701381052400; W12701381054500; W12701381051700; W12701380719000; W12701380718200; ",".","30 units","Blood products, collected in a manner that may have compromised the sterility of the products, were distributed. ",4/2/2013,"04/02/2013",8/14/2013,"08/14/2013"
"Biologics",65157,"Terminated","University Of Miami Miller School of Medicine Tissue Bank","Miami","FL","US","Voluntary: Firm Initiated","E-Mail","California","B-1882-13","Class II","Bone","0093440125",".","1 allograft","Human tissue allograft, processed in a manner that could cause contamination or cross-contamination during processing, as well as the introduction, transmission, or spread of communicable disease through the use of the HCT/P, was distributed. ",2/19/2013,"02/19/2013",7/17/2013,"07/17/2013"
"Devices",65158,"Ongoing","Medical Information Technology, Inc.","Westwood","MA","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution - USA, including Puerto Rico and the country of Canada.","Z-1365-2013","Class II","MEDITECH Bi-Directional interactive Communication Analyzer Interface; Integrates with MEDITECH's Laboratory Information System (LIS) with Other Vendor systems to manage the transfer of patient results and demographic information. ","Magic Releases 5.41, 5.52. 5.53, 5.62, 5.63, 5.64 and Client Server Releases 5.64, 5.65, 6.05, 6.06, 6.07",".","56 devices","Incorrect transmission of laboratory results. ",5/7/2013,"05/07/2013",5/29/2013,"05/29/2013"
"Devices",65159,"Ongoing","Maquet Cardiovascular Us Sales, Llc","Wayne","NJ","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution - USA including Arizona, Georgia, North Dakota, South Carolina, Texas and Tennessee, Internationally to United Arab Emirates, Austria, Brazil, Canada, Switzerland, China, Germany, Spain, France, United Kingdom, Italy, Japan, Singapore, Thailand, Turkey, Serbia, and South Africa.","Z-1622-2013","Class II","MAQUET Getinge Group Mobile Operating Table YUNO OTN GA 1433.01 EN 05. The YUNO OTN is used to support and position patients for surgical procedures immediately before, during and after the surgical phase. The table top is radio translucent and enables intraoperative use of X-ray equipment. ","YUNO OTN Mobile Operating Table: 1433.01F0 Extension Device: 1433.62A1",".","13 Tables; 24 Extension devices","MAQUET has identified a potential issue with the extension device handle (part number 1433.62A1) and will make enhancements to the YUNO table (part number 1433.01F0). Identification of the Extension device issue: By fully actuating the lever of the extension device handle, the operator's skin can enter a gap between the handle lever and a recess in the handle bar. When the lever is released, skin which might be within the gap could be pinched or cut.",4/26/2013,"04/26/2013",7/10/2013,"07/10/2013"
"Devices",65160,"Ongoing","Maytex Corp","Hayward","CA","US","Voluntary: Firm Initiated","Letter","Worldwide distribution: USA (nationwide) including states of: AL, AZ, CA, CO, FL, GA, HI, ID, IL, IN, MA, MD, ME, MI, MN, MO, MT, NE, NH, NJ, NM, NY, OK, OR, PA, PR, TN, TX, UT, WA, and WI; and country of: Mexico.","Z-1451-2013","Class II","Comfort brand Ear-Loop Face Mask, Item #: 3100, Model Numbers: # 3100B, # 3100P, # 3100G, # 3100Y, # 3100W; Product is manufactured and distributed by Maytex Corporation, CA Ear-loop face mask for basic medical/dental procedures. ","All cases of item #: 3100 face mask with PO #. PO #, Date of receipt: 809-01, 2/5/08; 837-02, 7/29/08; 852-03, 10/10/08; 901-01, 2/3/09; 921-02, 6/8/09; 923-03, 7/8/09; 926-04, 8/26/09; 931-05, 11/10/09; 942-06, 12/16/09; 001-01, 2/17/10; 003-03, 4/12/10; 002-02 , 3/24/10; 003-03A, 7/23/10; 042-04, 11/29/10; 105-01, 1/31/11; 117-02, 4/29/11; 127/03, 7/8/11; 147-04, 12/16/11; 202-01, 3/8/2012; 224-02, 5/24/2012; 235-03, 9/12/2012; 253-04 , 12//192012 ",".","43,915 Cases","Recent Lab testing conducted in March 2013 indicates that the product does not meet the standard of ''Differential Pressure of only 1.6 Delta P (mm H2O/cm2)'' as indicated on the box/package of the product; and also product manufactured between 2008 - 2012 cannot be guaranteed as Fluid Resistant. ",5/15/2013,"05/15/2013",6/12/2013,"06/12/2013"
"Devices",65161,"Ongoing","Siemens Medical Solutions USA, Inc","Malvern","PA","US","Voluntary: Firm Initiated","Letter","Nationwide Distribution","Z-0016-2014","Class II","Siemens RAD Fluoro Uro Systems - Luminos dRF, Ysio and Uroskop Omnia with software versions VB10D, VB10F, VB10C and VB10E. Fluroscopic X-Ray Systems","Material 10094910, with serial numbers 1036, 1045, 1025, 1040, 1041, 1032, 1047 and 1035; Material 10281013, with serial numbers 21221, 21223, 21213, 21089, 21098, 21163, 21171, 21194, 21212, 21186, 21188, 21167, 21187 and 21189; Material 10281163, with serial number 31114.",".","23","Siemens has discovered through product monitoring a potential malfunction when using system operating with software versions VB10D, VB10F, VB10C and VB10. During a RAD examination the possibility exists that radiation may continue longer than expected and may result in unnecessary dose applied during an acquisition. Additionally, it is not possible for the user to stop the radiation manually; however, there are emergency circuits active which will stop radiation through another independent mechanism. If the image quality of the overexposed image is unacceptable for diagnosis, the examination could potentially have to be repeated. The upgrade to software version VB10G resolves this potential malfunction. For patients who were treated with affected systems in the past, no measures such as additional treatment or aftercare are necessary.",5/6/2013,"05/06/2013",11/13/2013,"11/13/2013"
"Devices",65162,"Ongoing","Siemens Healthcare Diagnostics, Inc","East Walpole","MA","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution-USA (nationwide) and the countries of Canada, AE, AR, AT, AU, BA, BD, BE, BG, BO, BR, BY, CH, CL, CM, CN, CO, CR, CY, CZ, DE, DK, DO, DZ, EC, EE, EG, ES, FI, FR, GB, GR, GT, HK, HN, HR, HU, ID, IE, IL, IN, IR, IS, IT, JO, JP, KA, KR, KW, KZ, LB, LK, LT, LV, LY, MA, MK, MT, MX, MY, NI, NL, NO, NP, OM, PA, PE, PH, PK, PL, PT, PY, QA, RO, RU, SA, SE, SG, SK, SV, SY, TH, TM, TN, TR, TW, UA, UY, UZ, VE, VN, XS, and ZA.","Z-1882-2013","Class II","Dimension TSH Flex Reagent Cartridge (REF RF412). Intended to quantitatively measure human thyroid stimulating hormone (TSH, thyrotropin).","Per recall strategy.",".","39763","A rare variant of TSH, identified in a small cluster of patients, is not detected. ",5/10/2013,"05/10/2013",8/14/2013,"08/14/2013"
"Devices",65162,"Ongoing","Siemens Healthcare Diagnostics, Inc","East Walpole","MA","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution-USA (nationwide) and the countries of Canada, AE, AR, AT, AU, BA, BD, BE, BG, BO, BR, BY, CH, CL, CM, CN, CO, CR, CY, CZ, DE, DK, DO, DZ, EC, EE, EG, ES, FI, FR, GB, GR, GT, HK, HN, HR, HU, ID, IE, IL, IN, IR, IS, IT, JO, JP, KA, KR, KW, KZ, LB, LK, LT, LV, LY, MA, MK, MT, MX, MY, NI, NL, NO, NP, OM, PA, PE, PH, PK, PL, PT, PY, QA, RO, RU, SA, SE, SG, SK, SV, SY, TH, TM, TN, TR, TW, UA, UY, UZ, VE, VN, XS, and ZA.","Z-1883-2013","Class II","Dimension EXL LOCI Module TSHL Flex Reagent Cartridge (REF RF612). Intended to quantitatively measure human thyroid stimulating hormone (TSH, thyrotropin).","Per recall strategy.",".","33506","A rare variant of TSH, identified in a small cluster of patients, is not detected. ",5/10/2013,"05/10/2013",8/14/2013,"08/14/2013"
"Devices",65162,"Ongoing","Siemens Healthcare Diagnostics, Inc","East Walpole","MA","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution-USA (nationwide) and the countries of Canada, AE, AR, AT, AU, BA, BD, BE, BG, BO, BR, BY, CH, CL, CM, CN, CO, CR, CY, CZ, DE, DK, DO, DZ, EC, EE, EG, ES, FI, FR, GB, GR, GT, HK, HN, HR, HU, ID, IE, IL, IN, IR, IS, IT, JO, JP, KA, KR, KW, KZ, LB, LK, LT, LV, LY, MA, MK, MT, MX, MY, NI, NL, NO, NP, OM, PA, PE, PH, PK, PL, PT, PY, QA, RO, RU, SA, SE, SG, SK, SV, SY, TH, TM, TN, TR, TW, UA, UY, UZ, VE, VN, XS, and ZA.","Z-1884-2013","Class II","Dimension Vista System TSH Flex Reagent Cartridge (REF K6412). Intended to quantitatively measure human thyroid stimulating hormone (TSH, thyrotropin).","Per recall strategy.",".","18584","A rare variant of TSH, identified in a small cluster of patients, is not detected. ",5/10/2013,"05/10/2013",8/14/2013,"08/14/2013"
"Devices",65162,"Ongoing","Siemens Healthcare Diagnostics, Inc","East Walpole","MA","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution-USA (nationwide) and the countries of Canada, AE, AR, AT, AU, BA, BD, BE, BG, BO, BR, BY, CH, CL, CM, CN, CO, CR, CY, CZ, DE, DK, DO, DZ, EC, EE, EG, ES, FI, FR, GB, GR, GT, HK, HN, HR, HU, ID, IE, IL, IN, IR, IS, IT, JO, JP, KA, KR, KW, KZ, LB, LK, LT, LV, LY, MA, MK, MT, MX, MY, NI, NL, NO, NP, OM, PA, PE, PH, PK, PL, PT, PY, QA, RO, RU, SA, SE, SG, SK, SV, SY, TH, TM, TN, TR, TW, UA, UY, UZ, VE, VN, XS, and ZA.","Z-1885-2013","Class II","IMMULITE Systems Third Generation TSH (REF LKTS1 - 100T, LKTS5 - 500T, L2KTS2 - 200T, L2KTS6 - 600T). Intended to quantitatively measure human thyroid stimulating hormone (TSH, thyrotropin).","Per recall strategy.",".","51792","A rare variant of TSH, identified in a small cluster of patients, is not detected. ",5/10/2013,"05/10/2013",8/14/2013,"08/14/2013"
"Devices",65162,"Ongoing","Siemens Healthcare Diagnostics, Inc","East Walpole","MA","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution-USA (nationwide) and the countries of Canada, AE, AR, AT, AU, BA, BD, BE, BG, BO, BR, BY, CH, CL, CM, CN, CO, CR, CY, CZ, DE, DK, DO, DZ, EC, EE, EG, ES, FI, FR, GB, GR, GT, HK, HN, HR, HU, ID, IE, IL, IN, IR, IS, IT, JO, JP, KA, KR, KW, KZ, LB, LK, LT, LV, LY, MA, MK, MT, MX, MY, NI, NL, NO, NP, OM, PA, PE, PH, PK, PL, PT, PY, QA, RO, RU, SA, SE, SG, SK, SV, SY, TH, TM, TN, TR, TW, UA, UY, UZ, VE, VN, XS, and ZA.","Z-1886-2013","Class II","IMMULITE Systems Rapid TSH (REF LKRT1 - 100T, LKRT5 - 500 T, L2KRT2 - 200T, L2KRT6 - 600T). Intended to quantitatively measure human thyroid stimulating hormone (TSH, thyrotropin).","Per recall strategy.",".","13462","A rare variant of TSH, identified in a small cluster of patients, is not detected. ",5/10/2013,"05/10/2013",8/14/2013,"08/14/2013"
"Devices",65162,"Ongoing","Siemens Healthcare Diagnostics, Inc","East Walpole","MA","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution-USA (nationwide) and the countries of Canada, AE, AR, AT, AU, BA, BD, BE, BG, BO, BR, BY, CH, CL, CM, CN, CO, CR, CY, CZ, DE, DK, DO, DZ, EC, EE, EG, ES, FI, FR, GB, GR, GT, HK, HN, HR, HU, ID, IE, IL, IN, IR, IS, IT, JO, JP, KA, KR, KW, KZ, LB, LK, LT, LV, LY, MA, MK, MT, MX, MY, NI, NL, NO, NP, OM, PA, PE, PH, PK, PL, PT, PY, QA, RO, RU, SA, SE, SG, SK, SV, SY, TH, TM, TN, TR, TW, UA, UY, UZ, VE, VN, XS, and ZA.","Z-1881-2013","Class II","ADVIA Centaur Systems TSH3 Ultra ReadyPack ((REF 06491072 - 100 Tests, REF 06491080 - 500 Tests, REF 04862625 - 2500T). Intended to quantitatively measure human thyroid stimulating hormone (TSH, thyrotropin).","Per recall strategy.",".","172913","A rare variant of TSH, identified in a small cluster of patients, is not detected. ",5/10/2013,"05/10/2013",8/14/2013,"08/14/2013"
"Devices",65163,"Ongoing","Roche Diagnostics Operations, Inc.","Indianapolis","IN","US","Voluntary: Firm Initiated","Letter","Nationwide distribution: USA including states of: AL, CA, GA, FL, IL, IN, KS, KY, MA, MD, MI, MN, MO, NC, NY, OH, PA, TX, VA, VT, and WA.","Z-1727-2013","Class II","B-CrossLaps/serum (B-CTx in serum) REF 11972308 160 100 tests Immunoassay for the in vitro quantitative determination of degradation products of type I collagen in human serum and plasma as an aid in assessing bone resorption. The test may be used as an aid in monitoring antiresorptive therapies (e.g. bisphosphonates, hormone replacement therapy - HRT) in postmenopausal women and individuals diagnosed with osteopenia. The electrochemiluminescence immunoassay ECLIA is intended for use on Elecsys and cobas e immunoassay analyzers.","All lot numbers ",".","3056 units","Roche Diagnostics internal investigations in R&D have shown that the claims for biotin interference and the sample stability given in the Elecsys -CrossLaps (-CL) assay package insert version 5, could not be reproduced. The -CrossLaps test results contribute to the monitoring of antiresorptive therapy. False low or false normal results may lead to delayed diagnosis and treatment of osteoporosis in the short term. To date, no customer complaints have been reported.",4/25/2013,"04/25/2013",7/24/2013,"07/24/2013"
"Devices",65164,"Ongoing","GE Healthcare, LLC","Waukesha","WI","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution-USA (nationwide) including the states of AZ, CA, CO, CT, ID, MK, MI, NJ, NY, OH, TN, TX, and VA, and the countries of INDIA, AUSTRALIA, BAHRAIN, BANGLADESH, BOLIVIA, BOSNIA & HERZEGOWINA, BRAZIL, CANADA, CHILE, CHINA, COLOMBIA, CZECH REPUBLIC, EGYPT, EL SALVADOR, FINLAND, FRANCE, GERMANY, HONG KONG, HUNGARY, INDONESIA, IRAQ,ISRAEL, ITALY, JAPAN, REPUBLIC OF KOREA,LEBANON, MALAYSIA, MEXICO, NETHERLAND,NEW ZEALAND, OMAN, PARAGUAY, PERU., PHILIPPINES, RUSSIAN FEDERATION, SAUDI ARABIA, SERBIA, SINGAPORE, SLOVAKIA, SOUTH AFRICA, THAILAND, TURKEY, UNITED ARAB EMIRATES , UNITED KINGDOM, and VIET NAM.","Z-1443-2013","Class II","Canister: CO2 canister with GE part numbers 1407-3200-000, 1407-7004-000, or M1084850. Intended to provide general inhalation anesthesia and ventilatory support.","Canisters with date code of 02-2013 (Feb 2013) ",".","800","GE Healthcare has recently become aware of a potential safety issue involving the reusable CO2 absorbent canister accessory used with Aespire, Aespire View, Avance, Avance CS2, Aisys, ADU, 9100, M900, M904, 9300 systems. Reusable CO2 absorbent canisters accessories may not seal properly. ",5/14/2013,"05/14/2013",6/12/2013,"06/12/2013"
"Devices",65165,"Ongoing","Alphatec Spine, Inc.","Carlsbad","CA","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Nationwide Distribution.","Z-1421-2013","Class II","Leucadia Autolok'' Polyaxial Pedicle Screw System. Intended to help provide correction, immobilization and stabilization of spinal segments.","83010 85001 85002 83005-30 83005-35 83005-40 83005-45 83005-50 83006-30 83006-35 83006-40 83006-45 83006-50 83006-55 83006-60 83007-30 83007-35 83007-40 83007-45 83007-50 83007-55 83008-30 83008-35 83008-40 83008-45 83008-50 83008-55 83008-80 82001-1 Catalog Numbers: LA-HSS0010 LA-HDOO01 LA-CTOO02 LA-PS0530 LA-PS0535 LA-PS0540 LA-PS0545 LA-PS0550 LA-PS0630 LA-PS0635 LA-PS0640 LA-PS0645 LA-PS0650 LA-PS0655 LA-PS0660 LA-PS0730 LA-PS0735 LA-PS0740 LA-PS0745 LA-PS0750 LA-PS0755 LA-PS0830 LA-PS0835 LA-PS0840 LA-PS0845 LA-PS0850 LA-PS0855 LA-PS0880 LA-SOO01 Lots Affected: All ",".","1,814","Alphatec Spine initiated this medical device recall for the following reason: due to tolerancing, the flange of the Phygen Leucadia'' Autolok set screw may interfere with the top of the screw head prior to fully locking the rod. If this condition occurs, the polyaxial screw head and rod may fail to provide a rigid construct under loading. To date there have been no reports of patient injury, adverse events or complaints received for this issue.",5/6/2013,"05/06/2013",6/5/2013,"06/05/2013"
"Devices",65166,"Ongoing","Linvatec Corp. dba ConMed Linvatec","Largo","FL","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","US Distribution including the states of FL, KY, LA, MI, NC, and NY.","Z-1619-2013","Class II","GENESYS Cross FT Suture Anchor with Two #2 (5 metric) Hi-FI Registered Trade Mark Sutures Rx Only STERILE EO CONMED LINVATEC REF CFBC-4502. Reattachment of soft tissue to bone in orthopedic surgical procedures","Product Number CFBC-4502, Lot #431437",".","60 each of both units ","Incorrect blue/white suture was used.",3/6/2013,"03/06/2013",7/10/2013,"07/10/2013"
"Food",65167,"Ongoing","BIMBO Bakeries USA","Horsham","PA","US","Voluntary: Firm Initiated","press release","NC, SC, TN, VA","F-1554-2013","Class II","Hot Dog Buns 8 Count Earthgrains Baking companies, Inc. Horsham, PA 19044","Best By Date 5 - 21",,"8572","Due to the possible presence of metal fragments caused by a faulty manufacturing part at a North Carolina bakery",5/10/2013,"05/10/2013",7/3/2013,"07/03/2013"
"Food",65167,"Ongoing","BIMBO Bakeries USA","Horsham","PA","US","Voluntary: Firm Initiated","press release","NC, SC, TN, VA","F-1565-2013","Class II","8 Bakery Buns Sara Lee Hearty & Delicious Sesame Seed and Sara Lee Gourmet Sesame Seed Hamburger Buns Restaurant Style - 12 count Sara Lee, Downers Grove, IL 60515 ","Best By Date 5 - 21",,"8 count -1276, 12 count - 535","Due to the possible presence of metal fragments caused by a faulty manufacturing part at a North Carolina bakery",5/10/2013,"05/10/2013",7/3/2013,"07/03/2013"
"Food",65167,"Ongoing","BIMBO Bakeries USA","Horsham","PA","US","Voluntary: Firm Initiated","press release","NC, SC, TN, VA","F-1559-2013","Class II","Great Value 8 Jumbo Hamburger Buns Distributed By: Wal-Mart Stores, inc., Bentonville, AR 72716","Best By Date 5 - 21",,"336","Due to the possible presence of metal fragments caused by a faulty manufacturing part at a North Carolina bakery",5/10/2013,"05/10/2013",7/3/2013,"07/03/2013"
"Food",65167,"Ongoing","BIMBO Bakeries USA","Horsham","PA","US","Voluntary: Firm Initiated","press release","NC, SC, TN, VA","F-1572-2013","Class II","Hamburger Buns Bimbo Bakeries USA 255 Business Center Dr. Horsham, PA 19044 Food Service Hamburger Buns, Seeded and Unseeded, all counts: ","Best By Date 5 - 20",,"264","Due to the possible presence of metal fragments caused by a faulty manufacturing part at a North Carolina bakery",5/10/2013,"05/10/2013",7/3/2013,"07/03/2013"
"Food",65167,"Ongoing","BIMBO Bakeries USA","Horsham","PA","US","Voluntary: Firm Initiated","press release","NC, SC, TN, VA","F-1556-2013","Class II"," Colonial Party Pack Enriched Buns - 12 count Sara Lee, Downers Grove, IL 60515","Best By Date 5 - 20",,"1689","Due to the possible presence of metal fragments caused by a faulty manufacturing part at a North Carolina bakery",5/10/2013,"05/10/2013",7/3/2013,"07/03/2013"
"Food",65167,"Ongoing","BIMBO Bakeries USA","Horsham","PA","US","Voluntary: Firm Initiated","press release","NC, SC, TN, VA","F-1566-2013","Class II","8 Bakery Buns Sara Lee Hearty & Delicious White Sara Lee, Downers Grove, IL 60515","Best By Date 5 - 21",,"1505","Due to the possible presence of metal fragments caused by a faulty manufacturing part at a North Carolina bakery",5/10/2013,"05/10/2013",7/3/2013,"07/03/2013"
"Food",65167,"Ongoing","BIMBO Bakeries USA","Horsham","PA","US","Voluntary: Firm Initiated","press release","NC, SC, TN, VA","F-1569-2013","Class II","Food Service Hamburger Buns Wheat with Oat 12 CT Earthgrains Baking companies, Inc. Horsham, PA 19044","Best By Date 5 - 21",,"12","Due to the possible presence of metal fragments caused by a faulty manufacturing part at a North Carolina bakery",5/10/2013,"05/10/2013",7/3/2013,"07/03/2013"
"Food",65167,"Ongoing","BIMBO Bakeries USA","Horsham","PA","US","Voluntary: Firm Initiated","press release","NC, SC, TN, VA","F-1558-2013","Class II"," Colonial 12 Seeded Enriched Buns Sara Lee, Downers, Grove, IL 60515","Best By Date 5 - 21",,"868","Due to the possible presence of metal fragments caused by a faulty manufacturing part at a North Carolina bakery",5/10/2013,"05/10/2013",7/3/2013,"07/03/2013"
"Food",65167,"Ongoing","BIMBO Bakeries USA","Horsham","PA","US","Voluntary: Firm Initiated","press release","NC, SC, TN, VA","F-1570-2013","Class II","Foodservice Hamburger Buns - 12 Count Earthgrains Baking companies, Inc. Horsham, PA 19044","Best By Date 5 - 20",,"5326","Due to the possible presence of metal fragments caused by a faulty manufacturing part at a North Carolina bakery",5/10/2013,"05/10/2013",7/3/2013,"07/03/2013"
"Food",65167,"Ongoing","BIMBO Bakeries USA","Horsham","PA","US","Voluntary: Firm Initiated","press release","NC, SC, TN, VA","F-1562-2013","Class II","Kroger Sandwich Enriched Buns - 12 count Distributed By: The Kroger Co., Cincinnati, Ohio 45202","Best By Date 5 - 20",,"65","Due to the possible presence of metal fragments caused by a faulty manufacturing part at a North Carolina bakery",5/10/2013,"05/10/2013",7/3/2013,"07/03/2013"
"Food",65167,"Ongoing","BIMBO Bakeries USA","Horsham","PA","US","Voluntary: Firm Initiated","press release","NC, SC, TN, VA","F-1567-2013","Class II","Sunbeam 12 Enriched Hamburger Buns and Sunbeam 12 (Seeded) Hamburger Buns Earthgrains Baking companies, Inc. Horsham, PA 19044","Best By Date 5 - 20",,"Hamburger - 3262, Seeded - 215","Due to the possible presence of metal fragments caused by a faulty manufacturing part at a North Carolina bakery",5/10/2013,"05/10/2013",7/3/2013,"07/03/2013"
"Food",65167,"Ongoing","BIMBO Bakeries USA","Horsham","PA","US","Voluntary: Firm Initiated","press release","NC, SC, TN, VA","F-1571-2013","Class II","Foodservice Hamburger Buns - 20 Count Earthgrains Baking companies, Inc. Horsham, PA 19044 ","Best By Date 5 - 21",,"741","Due to the possible presence of metal fragments caused by a faulty manufacturing part at a North Carolina bakery",5/10/2013,"05/10/2013",7/3/2013,"07/03/2013"
"Food",65167,"Ongoing","BIMBO Bakeries USA","Horsham","PA","US","Voluntary: Firm Initiated","press release","NC, SC, TN, VA","F-1561-2013","Class II","Kroger White Jumbo Hamburger Buns - 8 Buns Distributed By: The Kroger Co. Cincinnati, Ohio 45202","Best By Date 5 - 21",,"214","Due to the possible presence of metal fragments caused by a faulty manufacturing part at a North Carolina bakery",5/10/2013,"05/10/2013",7/3/2013,"07/03/2013"
"Food",65167,"Ongoing","BIMBO Bakeries USA","Horsham","PA","US","Voluntary: Firm Initiated","press release","NC, SC, TN, VA","F-1573-2013","Class II","Seeded Hamburger Buns Bulk","Best By Date 5 - 20",,"982","Due to the possible presence of metal fragments caused by a faulty manufacturing part at a North Carolina bakery",5/10/2013,"05/10/2013",7/3/2013,"07/03/2013"
"Food",65167,"Ongoing","BIMBO Bakeries USA","Horsham","PA","US","Voluntary: Firm Initiated","press release","NC, SC, TN, VA","F-1560-2013","Class II","Kerns Beef Buns - 12 count Distributed By: K-VA-T Food Stores, Inc., Arbingdon, VA 24210","Best By Date 5 - 20",,"812","Due to the possible presence of metal fragments caused by a faulty manufacturing part at a North Carolina bakery",5/10/2013,"05/10/2013",7/3/2013,"07/03/2013"
"Food",65167,"Ongoing","BIMBO Bakeries USA","Horsham","PA","US","Voluntary: Firm Initiated","press release","NC, SC, TN, VA","F-1555-2013","Class II"," Colonial Cookout Enriched Buns - 12 count Earthgrains Baking companies, Inc. Horsham, PA 19044","Best By Date 5 - 20",,"1732","Due to the possible presence of metal fragments caused by a faulty manufacturing part at a North Carolina bakery",5/10/2013,"05/10/2013",7/3/2013,"07/03/2013"
"Food",65167,"Ongoing","BIMBO Bakeries USA","Horsham","PA","US","Voluntary: Firm Initiated","press release","NC, SC, TN, VA","F-1563-2013","Class II","Sara Lee Hearty & Delicious 100% Whole Wheat 8 Bakery Buns Sara lee, Downers Grove, IL 60515","Best By Date 5 - 21",,"1079","Due to the possible presence of metal fragments caused by a faulty manufacturing part at a North Carolina bakery",5/10/2013,"05/10/2013",7/3/2013,"07/03/2013"
"Food",65167,"Ongoing","BIMBO Bakeries USA","Horsham","PA","US","Voluntary: Firm Initiated","press release","NC, SC, TN, VA","F-1568-2013","Class II","Foodservice 100% Whole Wheat Hamburger Buns - 12 Ct Earthgrains Baking companies, Inc. Horsham, PA 19044","Best By Date 5 - 21",,"2930","Due to the possible presence of metal fragments caused by a faulty manufacturing part at a North Carolina bakery",5/10/2013,"05/10/2013",7/3/2013,"07/03/2013"
"Food",65167,"Ongoing","BIMBO Bakeries USA","Horsham","PA","US","Voluntary: Firm Initiated","press release","NC, SC, TN, VA","F-1564-2013","Class II","Sara Lee Classic White 12 Hamburger Buns Sara Lee, Downers Grove, IL 60515","Best By Date 5 - 20",,"39","Due to the possible presence of metal fragments caused by a faulty manufacturing part at a North Carolina bakery",5/10/2013,"05/10/2013",7/3/2013,"07/03/2013"
"Food",65167,"Ongoing","BIMBO Bakeries USA","Horsham","PA","US","Voluntary: Firm Initiated","press release","NC, SC, TN, VA","F-1557-2013","Class II"," Colonial Party Pack Sesame Seed Enriched Buns - 12 count Sara Lee, Downers Grove, IL 60515","Best By Date 5 - 20",,"593","Due to the possible presence of metal fragments caused by a faulty manufacturing part at a North Carolina bakery",5/10/2013,"05/10/2013",7/3/2013,"07/03/2013"
"Devices",65168,"Ongoing","Intuitive Surgical, Inc.","Sunnyvale","CA","US","Voluntary: Firm Initiated","Letter","Worldwide distribution: US (nationwide) and countries of: Austria, Belgium, Denmark, Finland, France, Germany, Ireland, Netherlands, Norway, South Korea, Sweden, Switzerland, and United Kingdom.","Z-1464-2013","Class II","da Vinci 5 mm Flared Instrument Cannulae for use with the da Vinci S and Si Surgical Systems. Used to establish a port of entry for Intuitive Surgical EndoWrist instruments","Model number 420262",".","2101 consignees","Intuitive Surgical is implementing a voluntary Field Action to implement a modified inspection process for the 5 mm Cannula (PN 420011) and 5 mm Flared Cannula (PN 420262).",5/6/2013,"05/06/2013",6/12/2013,"06/12/2013"
"Devices",65168,"Ongoing","Intuitive Surgical, Inc.","Sunnyvale","CA","US","Voluntary: Firm Initiated","Letter","Worldwide distribution: US (nationwide) and countries of: Austria, Belgium, Denmark, Finland, France, Germany, Ireland, Netherlands, Norway, South Korea, Sweden, Switzerland, and United Kingdom.","Z-1463-2013","Class II","da Vinci 5 mm Instrument Cannulae for use with the da Vinci S and Si Surgical Systems. Used to establish a port of entry for Intuitive Surgical EndoWrist instruments,","Model number 420011",".","2101 consignees","Intuitive Surgical is implementing a voluntary Field Action to implement a modified inspection process for the 5 mm Cannula (PN 420011) and 5 mm Flared Cannula (PN 420262).",5/6/2013,"05/06/2013",6/12/2013,"06/12/2013"
"Biologics",65169,"Terminated","Tacoma Pierce County Blood Bank","Tacoma","WA","US","Voluntary: Firm Initiated","Telephone","Washington","B-1928-13","Class II","Red Blood Cells Leukocytes Reduced Irradiated","W127813300875; ",,"1","Blood product, which was irradiated but labeled with incorrect irradiation status and expiration date, was distributed.",4/8/2013,"04/08/2013",7/31/2013,"07/31/2013"
"Biologics",65170,"Terminated","OneBlood, Inc.","Orlando","FL","US","Voluntary: Firm Initiated","Letter","Florida","B-1930-13","Class II","Platelets Pooled Leukocytes Reduced","W038112985393; W038112982318; ",,"2","Blood products, collected from a donor who traveled to an area considered endemic for malaria, were distributed.",3/13/2013,"03/13/2013",7/31/2013,"07/31/2013"
"Biologics",65170,"Terminated","OneBlood, Inc.","Orlando","FL","US","Voluntary: Firm Initiated","Letter","Florida","B-1929-13","Class II","Red Blood Cells Leukocytes Reduced","W038112210948; W038112124166; ",,"2","Blood products, collected from a donor who traveled to an area considered endemic for malaria, were distributed.",3/13/2013,"03/13/2013",7/31/2013,"07/31/2013"
"Devices",65171,"Ongoing","Alpine Biomed Aps","Skovlunde",,"DK","Voluntary: Firm Initiated","E-Mail","Worldwide Distribution - US Nationwide and the countries of: Germany, France, Bulgaria, India, Colombia, Tunisia, Saudi Arabia, Finland, Denmark, Brasil, Italy, Estonia, South Korea, Russia, Greece, Thailand, Israel, Poland, Turkey, Slovakia, Portugal, Switzerland, Hungary, Great Britain, Netherlands, China, Indonesia, Australia, Sweden, Spain, Iran, Singapore, Norway, Austria and Czech Republic.","Z-1407-2013","Class II","Natus neurology Dantec KEYPOINT.NET 2.20. Catalog/Part Numbers: 9031A070103, 9031A006502, 9033A071103, 9033A072102, 9031A070102, 9033A007402, 9033A071102, 9033A072103, 9033A0701, 9033A0711HA, 9033A071101, 9031A070101, 9031A006401, 9031A006501, 9033A004701, 9031A0032, 9033A0517, 9033A072101, 9031A0031, 9031A0701BV, 9033A0044, 9033A0073AA, 9031A0063, 9033A0523, 9033A071143, 9033A072143, 9031A006406, 9031A006506, 9031A070106, 9033A004606 9033A004706, 9033A007406, 9033A0537, 9033A0544, 9033A071106, 9033A072106, 9033A0524, 9033A0711BV, 9033A007401, 9033A0516, 9031A006403, 9031A006503, 9033A056403, 9033A0721BV, 9031A006402, 9031A006405, 9031A051306, 9031A070105, 9033A0072, 9033A007301, 9033A0711AA, 9033A0721AA Product Usage: Dantec KEYPOINT.NET Software 2.20 is installed on the Keypoint EMG System which is intended as an electro-physiological aid to assess diagnosis and prognosis and to monitor diseases of the central and peripheral nervous system. It can also be used to study functional aspects of nerves and muscles. ","SERIAL NUMBERS: 30317 22029 36079 36063 35182 36070 21963 21964 30068 30240 30170 22083 22085 30285 30286 30288 30323 30192 30214 30207 30325 30106 30168 21971 21972 30075 30212 21760 2717 30293 30365 36002 30193 36121 21962 36124 30364 35089 30045 35101 36090 21677 30362 35244 35209 36091 35297 36089 35032 35304 30167 30290 30110 30111 36012 30382 30410 30411 30412 30419 36107 36113 30407 35245 35293 35312 35181 35254 30315 30318 30384 35178 35173 35144 36186 36178 36199 2730 36125 36123 36132 30380 30428 20945 21249 21398 21580 21892 22120 30149 4268 20661 20704 20646 4140 4035 35190 30314 30328 30313 30327 30348 30401 30400 20322 21278 21272 21273 21678 21898 21747 21750 21823 21983 21741 21662 21989 22185 21821 22018 22017 22027 21826 21656 30124 30128 30130 30122 30032 30267 30268 30084 30022 30257 3637 4012 1956 20742 20737 20878 21581 21586 21587 20876 21110 21111 21156 21275 21281 21282 21283 21401 2363 35162 35163 35168 35170 35151 35024 35183 30349 36167 36168 36170 36171 36067 36111 36181 36183 20909 20952 20998 21634 21522 21614 21655 21673 21713 21718 21719 21720 21723 21724 21977 21978 21979 21980 22077 21981 22050 22051 22049 22052 22074 22076 30078 30079 30080 30082 30083 30102 30133 30134 30135 30208 30210 30209 30121 30132 30188 30187 30190 30189 30191 30220 30221 30223 30222 30304 30279 30057 3926 4099 4100 5248 5264 5288 20178 20746 4223 5152 35233 35102 35290 35120 35154 35225 35226 35227 35229 35230 35231 35232 35155 30330 30390 30391 30311 30347 36054 36056 36068 36119 36037 36069 36118 36108 36109 36106 30395 30406 36155 36164 36165 36196 36152 21471 20875 21863 21864 21862 21855 21928 21929 22209 22010 21919 30225 30227 30228 30211 30028 30141 30142 30027 20410 20794 20860 20870 2561 2856 2857 5369 5387 5094 5095 5273 5274 35052 35076 35077 35096 35100 30346 30358 30359 35305 35316 35309 30429 30123 30150 30259 30278 21540 4055 4320 5479 35200 35201 35115 30388 30393 36041 35318 36047 36100 36101 36103 36127 36131 35126 35234 35280 35285 36046 36099 35259 35287 36049 36102 30392 36145 ",".","871 licenses installed","Alpine Biomed ApS is recalling Natus neurology Dantec KEYPOINT.NET ver. 2.20 Software due to the presence of a software bug.",4/9/2013,"04/09/2013",6/5/2013,"06/05/2013"
"Drugs",65172,"Ongoing","King Legacy, a wholly owned subsidiary of Pfizer","Bristol","TN","US","Voluntary: Firm Initiated","Letter","Nationwide and Puerto Rico","D-429-2013","Class II","Levoxyl (levothyroxine sodium) tablets, USP, 150 mcg, packaged in a) 100-count bottles (NDC 60793-858-01) and b) 1000-count bottles (NDC 60793-858-10), Rx only, Manufactured and Distributed by: King Pharmaceuticals, Inc., Bristol, TN 37620","Lot # a) 65066, Exp. 5/13 and 65644, Exp. 7/13; b) 64327, Exp. 4/13 and 65772, Exp. 7/13",".","56,405 bottles","Subpotent Drug: The products were below specification for potency at the expiry stability point.",4/30/2013,"04/30/2013",5/29/2013,"05/29/2013"
"Drugs",65172,"Ongoing","King Legacy, a wholly owned subsidiary of Pfizer","Bristol","TN","US","Voluntary: Firm Initiated","Letter","Nationwide and Puerto Rico","D-423-2013","Class II","Levoxyl (levothyroxine sodium) tablets, USP, 75 mcg, packaged in a) 100-count bottles (NDC 60793-852-01) and b) 1000-count bottles (NDC 60793-852-10), Rx only, Manufactured and Distributed by: King Pharmaceuticals, Inc., Bristol, TN 37620","Lot # a) 64197, Exp. 4/13; 64339, Exp. 4/13; 65061, Exp. 5/13; 65236, Exp. 6/13; 65917, Exp. 8/13; 66122, Exp. 8/13; and 66427, Exp. 9/13; b) 64340, Exp. 4/13; 64933, Exp. 4/13; 65062, Exp. 5/13; 65237, Exp. 6/13; 65238, Exp. 6/13; and 66121, Exp. 8/13",".","194,142 bottles","Subpotent Drug: The products were below specification for potency at the expiry stability point.",4/30/2013,"04/30/2013",5/29/2013,"05/29/2013"
"Drugs",65172,"Ongoing","King Legacy, a wholly owned subsidiary of Pfizer","Bristol","TN","US","Voluntary: Firm Initiated","Letter","Nationwide and Puerto Rico","D-426-2013","Class II","Levoxyl (levothyroxine sodium) tablets, USP, 112 mcg, packaged in a) 100-count bottles (NDC 60793-855-01) and b) 1000-count bottles (NDC 60793-855-10), Rx only, Manufactured and Distributed by: King Pharmaceuticals, Inc., Bristol, TN 37620","Lot # a) 64936, Exp. 5/13; 65634, Exp. 7/13; 66295, Exp. 9/13; 66669, Exp. 11/13; b) 65063, Exp. 5/13 and 65767, Exp. 7/13",".","107,236 bottles","Subpotent Drug: The products were below specification for potency at the expiry stability point.",4/30/2013,"04/30/2013",5/29/2013,"05/29/2013"
"Drugs",65172,"Ongoing","King Legacy, a wholly owned subsidiary of Pfizer","Bristol","TN","US","Voluntary: Firm Initiated","Letter","Nationwide and Puerto Rico","D-421-2013","Class II","Levoxyl (levothyroxine sodium) tablets, USP, 25 mcg, packaged in a) 100-count bottles (NDC 60793-850-01) and b) 1000-count bottles (NDC 60793-850-10), Rx only, Manufactured and Distributed by: King Pharmaceuticals, Inc., Bristol, TN 37620","Lot # a) 65228, Exp. 06/13; 65636, Exp. 08/13; b) 65180, Exp. 05/13; 65769, Exp. 07/13",".","51,591 bottles","Subpotent Drug: The products were below specification for potency at the expiry stability point.",4/30/2013,"04/30/2013",5/29/2013,"05/29/2013"
"Drugs",65172,"Ongoing","King Legacy, a wholly owned subsidiary of Pfizer","Bristol","TN","US","Voluntary: Firm Initiated","Letter","Nationwide and Puerto Rico","D-425-2013","Class II","Levoxyl (levothyroxine sodium) tablets, USP, 100 mcg, packaged in a) 100-count bottles (NDC 60793-854-01) and b) 1000-count bottles (NDC 60793-854-10), Rx only, Manufactured and Distributed by: King Pharmaceuticals, Inc., Bristol, TN 37620","Lot # a) 64341, Exp 04/13; 64928, Exp. 5/13; 65064, Exp. 5/13; 65233, Exp. 7/13; 66162, Exp. 8/13; 66365, Exp. 10/13; and 66677, Exp. 11/13; b) 64342, Exp. 4/13; 64929, Exp. 5/13; 65065, Exp. 5/13; 65234, Exp. 7/13; 65539, Exp. 7/13; 65901, Exp. 8/13; and 66163, Exp. 8/13",".","195,201 bottles","Subpotent Drug: The products were below specification for potency at the expiry stability point.",4/30/2013,"04/30/2013",5/29/2013,"05/29/2013"
"Drugs",65172,"Ongoing","King Legacy, a wholly owned subsidiary of Pfizer","Bristol","TN","US","Voluntary: Firm Initiated","Letter","Nationwide and Puerto Rico","D-422-2013","Class II","Levoxyl (levothyroxine sodium) tablets, USP, 50 mcg, packaged in a) 100-count bottles (NDC 60793-851-01) and b) 1000-count bottles (NDC 60793-851-10), Rx only, Manufactured and Distributed by: King Pharmaceuticals, Inc., Bristol, TN 37620","Lot # a) 64934, Exp. 4/13; 65059, Exp. 5/13; 65179, Exp. 4/13; 65630, Exp. 7/13; 65916, Exp. 8/13; 66367, Exp. 10/13; and 66718, Exp. 11/13; b) 64338, Exp. 4/13; 64932, Exp. 4/13; 65060, Exp. 5/13; 65235, Exp. 6/13; 65853, Exp. 6/13; and 65962, Exp. 7/13",".","195,699 bottles","Subpotent Drug: The products were below specification for potency at the expiry stability point.",4/30/2013,"04/30/2013",5/29/2013,"05/29/2013"
"Drugs",65172,"Ongoing","King Legacy, a wholly owned subsidiary of Pfizer","Bristol","TN","US","Voluntary: Firm Initiated","Letter","Nationwide and Puerto Rico","D-424-2013","Class II","Levoxyl (levothyroxine sodium) tablets, USP, 88 mcg, packaged in a) 100-count bottles (NDC 60793-853-01) and b) 1000-count bottles (NDC 60793-853-10), Rx only, Manufactured and Distributed by: King Pharmaceuticals, Inc., Bristol, TN 37620","Lot # a) 64935, Exp. 5/13; 65239, Exp. 6/13; 65900, Exp. 8/13; 66370, Exp. 10/13; and 66391, Exp. 9/13; b) 64927, Exp. 5/13; and 65240, Exp. 6/13",".","112,914 bottles","Subpotent Drug: The products were below specification for potency at the expiry stability point.",4/30/2013,"04/30/2013",5/29/2013,"05/29/2013"
"Drugs",65172,"Ongoing","King Legacy, a wholly owned subsidiary of Pfizer","Bristol","TN","US","Voluntary: Firm Initiated","Letter","Nationwide and Puerto Rico","D-428-2013","Class II","Levoxyl (levothyroxine sodium) tablets, USP, 137 mcg, packaged in a) 100-count bottles (NDC 60793-857-01) and b) 1000-count bottles (NDC 60793-857-10), Rx only, Manufactured and Distributed by: King Pharmaceuticals, Inc., Bristol, TN 37620","Lot # a) 64190, Exp. 4/13; 64331, Exp. 6/13; 65642, Exp. 7/13; and 66297, Exp. 9/13; b) 64326, Exp. 4/13; 64332, Exp. 6/13; and 65771, Exp. 7/13",".","77,272 bottles","Subpotent Drug: The products were below specification for potency at the expiry stability point.",4/30/2013,"04/30/2013",5/29/2013,"05/29/2013"
"Drugs",65172,"Ongoing","King Legacy, a wholly owned subsidiary of Pfizer","Bristol","TN","US","Voluntary: Firm Initiated","Letter","Nationwide and Puerto Rico","D-427-2013","Class II","Levoxyl (levothyroxine sodium) tablets, USP, 125 mcg, packaged in a) 100-count bottles (NDC 60793-856-01) and b) 1000-count bottles (NDC 60793-856-10), Rx only, Manufactured and Distributed by: King Pharmaceuticals, Inc., Bristol, TN 37620","Lot # a) 64333, Exp. 5/13; 64937, Exp. 6/13; 65629, Exp. 7/13; and 66296, Exp. 9/13; b) 64931, Exp. 5/13 and 65766, Exp. 7/13",".","103,796 bottles","Subpotent Drug: The products were below specification for potency at the expiry stability point.",4/30/2013,"04/30/2013",5/29/2013,"05/29/2013"
"Drugs",65172,"Ongoing","King Legacy, a wholly owned subsidiary of Pfizer","Bristol","TN","US","Voluntary: Firm Initiated","Letter","Nationwide and Puerto Rico","D-430-2013","Class II","Levoxyl (levothyroxine sodium) tablets, USP, 175 mcg, packaged in a) 100-count bottles (NDC 60793-859-01) and b) 1000-count bottles (NDC 60793-859-10), Rx only, Manufactured and Distributed by: King Pharmaceuticals, Inc., Bristol, TN 37620","Lot # a) 64329, Exp. 5/13; 65229, Exp. 6/13; and 65913, Exp. 9/13; b) 64330, Exp. 5/13; 65230, Exp. 6/13; and 65915, Exp. 9/13",".","51,438 bottles","Subpotent Drug: The products were below specification for potency at the expiry stability point.",4/30/2013,"04/30/2013",5/29/2013,"05/29/2013"
"Drugs",65172,"Ongoing","King Legacy, a wholly owned subsidiary of Pfizer","Bristol","TN","US","Voluntary: Firm Initiated","Letter","Nationwide and Puerto Rico","D-431-2013","Class II","Levoxyl (levothyroxine sodium) tablets, USP, 200 mcg, packaged in a) 100-count bottles (NDC 60793-860-01) and b) 1000-count bottles (NDC 60793-860-10), Rx only, Manufactured and Distributed by: King Pharmaceuticals, Inc., Bristol, TN 37620","Lot # a) 64301, Exp. 4/13 and 65628, Exp. 7/13; b) 64300, Exp. 4/13 and 65765, Exp. 7/13",".","33,227 bottles","Subpotent Drug: The products were below specification for potency at the expiry stability point.",4/30/2013,"04/30/2013",5/29/2013,"05/29/2013"
"Devices",65173,"Ongoing","Edwards Lifesciences, LLC","Draper","UT","US","Voluntary: Firm Initiated","Letter","Worldwide distribution: US Nationwide and country of Canada.","Z-1542-2013","Class II","QuickDraw Venous Cannula with Insertion Kit. ThruPort Systmes. Models QD22 (22 Fr) and QD25 (25 Fr). The product is packaged sterile and non-pyrogenic in a sealed, peel-type pouch. Two pouches (cannula and accessories) go into one shelf carton. One shelf carton goes in one shipper carton. Use of the QuickDraw venous cannula is indicated for patients undergoing cardiopulmonary bypass. The QuickDraw venous cannula serves to drain non-oxygenated blood from the venae cavae or right atrium during cardiopulmonary bypass. The product is packaged sterile and nona pyrogenic in a sealed, peel-type pouch. ","Model QD22: Lot No. 59049758, 59054488, 59067502, 59074170, 59081626, 59083736, 59091652, 59094887, 59114755, 59117451, 59134508, 59149651, 59154310, 59178579, 59201243, 59212118, 59222657, 59233636, 59233637, 59246684, 59246701, 59255899, 59255900, 59269439, 59284780, 59287725, 59296462, 59299605, 59315339, 59320575, 59334652, 59356129, 59360072, 59365198, 59365199, 59374009, 59384309, 59390552, 59394166, 59394167, 59421250, 59448841 Model QD25: Lot No. 59046082,59046847,59052393,59052395,59056270,59059029,59060798,59062681,59069772,59073141,59077234,59079573,59085168,59085169,59097289,59101637,59106005,59110720,59122491,59126281,59131923,59140133,59142266,59143453,59145027,59158524,59158579,59163164,59184252,59191107,59201246,59207044,59209886,59214360,59214361,59216991,59222658,59222659,59233651,59246685,59246703,59255901,59268625,59284781,59287728,59296463,59299610,59313057,59320582,59320583,59334656,59344191,59346468,59352608,59356135,59360084,59374014,59374015,59414791,59425355,59437699,59437700,59448853",".","22,616","Edwards is recalling the QuickDraw Venous Cannula due to complaints of cannula separation during withdrawal of the device when the Percutaneous insertion method is used. ",5/14/2013,"05/14/2013",6/19/2013,"06/19/2013"
"Food",65174,"Ongoing","Smiling Hill Farm, Inc. dba Silvery Moon Creamery","Westbrook","ME","US","Voluntary: Firm Initiated","Telephone","ME, NH, CT","F-1477-2013","Class II","Smiling Hill Farm brand Butter, 1/2 lb, 5 lb; Unlabeled: 1/2 lb, 5 lb, 30-40 lb (variable in 5 gallon buckets) Product in plastic snap-lid containers. ","E4-11, E5-11, E6-11, A1-12, A2-12, A3-12, A4-12, A5-12, A6-12, A7-12, A8-12, A9-12, A10-12, A11-12, A12-12, B1-12, B2-12, B3-12, B4-12, B5-12, B6-12, B7-12, B8-12, B9-12, B10-12, B11-12, B12-12, C1-12, C2-12, C3-12, C4-12, C5-12, C6-12, C7-12, C8-12, C9-12, C10-12, C11-12, C12-12, D1-12, D2-12, D3-12, D4-12, D5-12, D6-12, D7-12, D8-12, D9-12, D10-12, D11-12, D12-12, E1-12, E2-12, E3-12, E4-12, E5-12, E6-12, E7-12, E8-12, E9-12, E10-12, E11-12, E12-12, F1-12, F2-12, F3-12, F4-12, F5-12, F6-12, F7-12, F8-12, F9-12, A1-13, A2-13, A3-13, A4-13, A5-13, A6-13, A7-13, A8-13, A9-13, A10-13, A11-13, A12-13, B1-13, B2-13, B3-13, B4-13, B5-13, B6-13, B7-13, B8-13, B9-13, B10-13, B11-13, B12-13, C1-13",".","9046 pounds","Elevated standard plate counts and detectable coliform bacteria. ",5/10/2013,"05/10/2013",6/12/2013,"06/12/2013"
"Devices",65175,"Ongoing","Embla System Llc","Tonawanda","NY","US","Voluntary: Firm Initiated","Letter","Worldwide distribution: US (nationwide) including states of: CO, AK, WA, CA, WI, MI, MA OH, DE, FL CA, CT, TX, IL, GA, PA, AZ, DC, VA, MD, UT, IN, MO, NY, NC, OR, NV, NJ, NH, DE, and country of: Canada.","Z-1532-2013","Class II","embla Embletta Gold (It functions as a Polysomnography Recorder and Ventilator Effort Recorder). The Embletta Gold is a battery operated device which records physiologic signals used in the diagnosis of sleep disorders. It is intended to be used for adult and pediatric (excluding neonatal and infant) studies. The recorder is not equiped with an alarm device and is not intended to be used as a life monitor. It may be used in a variety of configurations and the recording of physiologic signals of a sleeping patient. Item Numbers: RMIV003465 RMIV017570 RMRE008075 UI009108 UI010814 UI013848 RMIV019053 RMIV019328 RMIV019340 RMIV019634 RMIV020254 1010005552 1010005585 1010002453 1010001588 135150668 1010003915 1010002669 RMIV019542 1010002370 UI018933 RMIV019638 RMIV019850 RMIV020166 UI012625 RMIV019235 166758580 1010007510 UI007649 RMIV020079 RMIV013196 1010002697 RMIV019658 UI016466 RMIV019659 1010002034 UI016112 UI018160 1010007423 RMRE007779 UI018158 RMIV020145 1010001332 1010002431 1010002432 1010001378 1010006090 1010007484 1010004750 1010003658 1010007351 1010002688 1010002699 UI008431 RMIV009745 RMIV019679 1010007005 1010002088 UI009365 1010003611 1010006891 UI018570 UI022540 1010002262 RMIV019517 RMIV019572 RMRE007959 UI006113 RMIV006948 UI013856 RMIV016367 RMIV019395 RMIV020112 1010005434 1010006883 RMRE007326 RMIV019237 1010006887 1010001991 1010003732 1010003984 UI002603 1010004266 1010006478 1010006800 RMIV019397 1010001928 1010001729 RMIV019166 RMIV019746 RMRE008072 UI016332 UI007631 1010002320 RMIV018044 RMRE007777 1010003067 1010005000 1010005287 RMIV019076 RMIV020194 1010000243 1010003543 1010006931 RMIV017565 RMIV019454 RMRE008087 156096 159046 RMIV020029 1010001256 1010003438 RMIV019940 RMRE008074 1010003546 UI012639 118018636 1010003507 RMIV003685 ","Serial Numbers: EBG-C1000497 C0914092-EBG EBG-C1002589 EBG-C1002598 EBG-C1001659 EBG-C1001832 EBG-C1001835 EBG-C1001843 EBG-C1001845 EBG-C1002253 EBG-C1002473 EBG-C1002504 EBG-C1002519 EBG-C1002537 EBG-C1002539 EBG-C1001367 EBG-C1001378 EBG-C1001763 EBG-C1000265 EBG-C1002607 EBG-C1002542 EBG-C1003212 EBG-C1001834 EBG-C1001858 EBG-C1001889 EBG-C1002445 EBG-C1003052 EBG-C1002502 EBG-C1002508 EBG-C1001776 C0901065-EBG EBG-C1003078 EBG-C1003084 EBG-C1003085 EBG-C1003161 EBG-C1003165 EBG-C1001230 EBG-C1001275 EBG-C1002688 EBG-C1002500 EBG-C1003055 EBG-C1001970 EBG-C1001972 EBG-C1001973 EBG-C1001983 EBG-C1001986 EBG-C1001518 EBG-C1000112 EBG-C1001308 EBG-C1002771 EBG-C1002863 EBG-c1001330 EBG-C1001237 C0901015-EBG EBG-C1000118 EBG-C1001394 EBG-C1001411 EBG-C1002871 EBG-C1003067 EBG-C1002602 EBG-C1002526 EBG-C1003206 EBG-C1002321 EBG-C1000100 EBG-C1000491 EBG-C1002376 EBG-C1000032 EBG-C1001303 EBG-C1002819 EBG-C1002920 EBG-C1002530 EBG-C1002538 EBG-C1000961 EBG-C1002912 C0914083-EBG C0917019-EBG EBG-C1002844 EBG-C1002864 EBG-C1002924 EBG-C1002935 EBG-C1001859 EBG-C1003024 EBG-C1000061 EBG-C1002532 EBG-C1001181 EBG-C1001376 EBG-C1001546 EBG-C1001374 EBG-C1001884 EBG-C1000565 EBG-C1000101 EBG-C1000144 EBG-C1000160 EBG-C1000085 EBG-C1001228 EBG-C1001346 EBG-C1001312 EBG-C1001205 EBG-C1002974 EBG-C1003162 EBG-C1001360 EBG-C1000015 EBG-C1000097 EBG-C1000473 EBG-C1001627 C0914068-EBG EBG-C1000987 EBG-C1000991 EBG-C1001000 EBG-C1001088 EBG-C1001097 EBG-C1001110 EBG-C1001121 EBG-C1001122 EBG-C1001123 EBG-C1001124 EBG-C1001134 EBG-C1001387 C0908065-EBG EBG-C1002250 EBG-C1002297 EBG-C1002309 EBG-C1002311 EBG-C1002460 EBG-C1002464 EBG-C1002469 C0837085-EBG EBG-C1000018 EBG-C1001847 EBG-C1001554 EBG-C1002371 EBG-C1002404 EBG-C1002409 EBG-C1002994 EBG-C1000002 EBG-C1000427 EBG-C1002588 EBG-C1002603 EBG-C1002842 EBG-C1002852 EBG-C1002862 EBG-C1002882 EBG-C1002886 EBG-C1002893 EBG-C1002933 EBG-C1002934 EBG-C1000574 EBG-C1003044 EBG-C1002890 EBG-C1001093 EBG-C1001094 EBG-C1001105 EBG-C1001107 EBG-C1001113 EBG-C1001125 EBG-C1001128 E",".","519 units were calibrated at the service center","Calibration error for Embla Embletta Gold units calibrated through service center between June 15, 2012 to February 27, 2013. This calibration error could cause a clinician to over titrate the patient and prescribe a therapy pressure higher than is necessary.",4/24/2013,"04/24/2013",6/19/2013,"06/19/2013"
"Devices",65176,"Ongoing","Leibel-Flarsheim Company LLC","Cincinnati","OH","US","Voluntary: Firm Initiated","Letter","Nationwide Distribution (US), including the states of TN, KY, CO, KS, CT, HI, and AZ.","Z-1753-2013","Class II","Hydra Vision DR 60/80 System, Models 700539 and 700540, Liebel-Flarshiem Company. The System is used in radiologic imaging procedures.","The following catalog numbers, serial numbers and associated manufacturing dates are affected by this recall: 700539 CI0807H273 August2007; 700539 CI0106H162 January 2006; 700539 CI1010H523 October 2010; 700539 CI0811H567 August 2011; 700539 CI0108H313 January 2008; 700539 CI0309H418 March 2009; 700539 15031229 Apri12003; 700539 14031227 Apri12003; 700539 CI0404H045 January 2005; 700539 CI0504H054 May 2004; 700539 CI1106H208 November 2006; 700539 CI0509H424 May 2009 ",".","12 units","A complaint was received in which a hospital physicist indicated the dosage was too high on the HUT system. During the service call the systems Maximum Fluoro Dose was found to be 30 R/min which is three times the Maximum Fluoro Dose limit of 10 R/min. ",4/25/2013,"04/25/2013",7/24/2013,"07/24/2013"
"Biologics",65177,"Terminated","OneBlood, Inc.","Orlando","FL","US","Voluntary: Firm Initiated","E-Mail","Florida","B-1931-13","Class II","Blood and Blood Products for Reprocessing","W038111360397; ",,"1","Blood product, collected from a donor who was at risk for variant Creutzfeldt-Jakob Disease (vCJD), was distributed.",4/2/2013,"04/02/2013",7/31/2013,"07/31/2013"
"Biologics",65178,"Terminated","American National Red Cross The","Pomona","CA","US","Voluntary: Firm Initiated","FAX","California","B-1941-13","Class II","Blood and Blood Products for Reprocessing","006LJ61025",,"1 unit","Blood product, collected from an ineligible donor, was distributed. ",2/28/2013,"02/28/2013",7/31/2013,"07/31/2013"
"Biologics",65178,"Terminated","American National Red Cross The","Pomona","CA","US","Voluntary: Firm Initiated","FAX","California","B-1940-13","Class II","Red Blood Cells Leukocytes Reduced","006LJ61025",,"1 unit","Blood product, collected from an ineligible donor, was distributed. ",2/28/2013,"02/28/2013",7/31/2013,"07/31/2013"
"Drugs",65180,"Ongoing","Pentec Health","Boothwyn","PA","US","Voluntary: Firm Initiated","Telephone","Dialysis Centers Direct to patient","D-585-2013","Class II","IDPN (Intradialytic Parenteral Nutrition - dialysate solution with added amino acids), a) 490mL bag, b) 500mL bag, and c) 590mL bag, Pentec Health Inc., 4 Creek Parkway Suite A, Boothwyn, PA 19061-3132","Compounding Date: a) 04/25/13, b) 04/24/13 Discard After: a) 05/20/13, b) and c) 05/15/13 ",".","3 Bags","Lack of Assurance of Sterility: Sterility could not be assured for compounded sterile renal nutritional prescriptions.",5/15/2013,"05/15/2013",6/12/2013,"06/12/2013"
"Drugs",65180,"Ongoing","Pentec Health","Boothwyn","PA","US","Voluntary: Firm Initiated","Telephone","Dialysis Centers Direct to patient","D-582-2013","Class II","Baxter Ultrabag 1.5% Amino Acids (Intraperitoneal Parenteral Nutrition - dialysate solution with added amino acids), in a) 1500mL and b) 3000mL bags. Pentec Health Inc., 4 Creek Parkway Suite A, Boothwyn, PA 19061-3132","Date: 04/30/13 Discard After: 05/21/13 ",".","3 units","Lack of Assurance of Sterility: Sterility could not be assured for compounded sterile renal nutritional prescriptions.",5/15/2013,"05/15/2013",6/12/2013,"06/12/2013"
"Drugs",65180,"Ongoing","Pentec Health","Boothwyn","PA","US","Voluntary: Firm Initiated","Telephone","Dialysis Centers Direct to patient","D-581-2013","Class II","Proplete 34 - 39 KG (Intradialytic Parenteral Nutrition composed of amino acids, dextrose and sterile water), in 330mL bag, Pentec Health Inc., 4 Creek Parkway Suite A, Boothwyn, PA 19061-13132","Compounding Date: 4/25/13 Discard after: 5/16/13",".","1 Bag","Lack of Assurance of Sterility: Sterility could not be assured for compounded sterile renal nutritional prescriptions.",5/15/2013,"05/15/2013",6/12/2013,"06/12/2013"
"Drugs",65180,"Ongoing","Pentec Health","Boothwyn","PA","US","Voluntary: Firm Initiated","Telephone","Dialysis Centers Direct to patient","D-592-2013","Class II","Proplete 45 - 51 KG (Intraperitoneal Parenteral Nutrition - dialysate solution with added amino acids), in 435mL bag, Pentec Health Inc., 4 Creek Parkway Suite A Boothwyn, PA 19061-3132 ","Compounding Date: 04/24/13 Discard after: 5/15/13 ",".","4 Bags","Lack of Assurance of Sterility: Sterility could not be assured for compounded sterile renal nutritional prescriptions.",5/15/2013,"05/15/2013",6/12/2013,"06/12/2013"
"Drugs",65180,"Ongoing","Pentec Health","Boothwyn","PA","US","Voluntary: Firm Initiated","Telephone","Dialysis Centers Direct to patient","D-593-2013","Class II","Baxter LL bag 1% Amino Acids w/KCL (Intraperitoneal Parenteral Nutrition - dialysate solution with added amino acids and KCL), in 3000mL bag, Pentec Health Inc., 4 Creek Parkway Suite A, Boothwyn, PA 19061-3132","Compounding Date: 04/29/13 Discard after: 5/21/13 ",".","1 Bag","Lack of Assurance of Sterility: Sterility could not be assured for compounded sterile renal nutritional prescriptions.",5/15/2013,"05/15/2013",6/12/2013,"06/12/2013"
"Drugs",65180,"Ongoing","Pentec Health","Boothwyn","PA","US","Voluntary: Firm Initiated","Telephone","Dialysis Centers Direct to patient","D-591-2013","Class II","Proplete 90+ KG (Intraperitoneal Parenteral Nutrition - dialysate solution with added amino acids), in 805mL bag, Pentec Health Inc., 4 Creek Parkway Suite A Boothwyn, PA 19061-3132 ","Compounding Date: 04/23/13 Discard after: 5/15/13 ",".","1 Bag","Lack of Assurance of Sterility: Sterility could not be assured for compounded sterile renal nutritional prescriptions.",5/15/2013,"05/15/2013",6/12/2013,"06/12/2013"
"Drugs",65180,"Ongoing","Pentec Health","Boothwyn","PA","US","Voluntary: Firm Initiated","Telephone","Dialysis Centers Direct to patient","D-583-2013","Class II","Baxter LL bag 1% Amino Acids (Intraperitoneal Parenteral Nutrition - dialysate solution with added amino acids), in a) 3000mL bag, b) 5000mL bag and c) 6000mL bag, Pentec Health Inc., 4 Creek Parkway Suite A, Boothwyn, PA 19061-3132","a) Compounding Date: 04/30/13 Discard After: 05/21/13 b) Compounding Date: 04/30/13 Discard After: 05/21/13 c) Compounding Date: 04/25/13, 04/30/13 Discard After: 05/16/13, 05/21/13 ",".","5 Bags","Lack of Assurance of Sterility: Sterility could not be assured for compounded sterile renal nutritional prescriptions.",5/15/2013,"05/15/2013",6/12/2013,"06/12/2013"
"Drugs",65180,"Ongoing","Pentec Health","Boothwyn","PA","US","Voluntary: Firm Initiated","Telephone","Dialysis Centers Direct to patient","D-586-2013","Class II","Proplete 40 - 44 KG (Intradialytic Parenteral Nutrition - dialysate solution with added amino acids), in a) 385mL and b) 390mL, Pentec Health Inc 4 Creek Parkway Suite A Boothwyn, PA 19061-3132 ","Compounding Date: 04/24/13 Discard after: 05/15/13 ",".","9 Bags","Lack of Assurance of Sterility: Sterility could not be assured for compounded sterile renal nutritional prescriptions.",5/15/2013,"05/15/2013",6/12/2013,"06/12/2013"
"Drugs",65180,"Ongoing","Pentec Health","Boothwyn","PA","US","Voluntary: Firm Initiated","Telephone","Dialysis Centers Direct to patient","D-594-2013","Class II","Baxter LL bag 1.5% Amino Acids (Intraperitoneal Parenteral Nutrition - dialysate solution with added amino acids), in a) 1000mL bag, b) 2000mL bag, c) 2500mL bag, d) 5000mL bag, and e) 6000mL bag, Pentec Health Inc., 4 Creek Parkway Suite A, Boothwyn, PA 19061-3132","Compounding Date: 04/24/13, 04/29/13 Discard after: 5/21/13, 05/22/13 ",".","8 Bags","Lack of Assurance of Sterility: Sterility could not be assured for compounded sterile renal nutritional prescriptions.",5/15/2013,"05/15/2013",6/12/2013,"06/12/2013"
"Drugs",65180,"Ongoing","Pentec Health","Boothwyn","PA","US","Voluntary: Firm Initiated","Telephone","Dialysis Centers Direct to patient","D-584-2013","Class II","Fresenius bag 1% Amino Acids (Intraperitoneal Parenteral Nutrition - dialysate solution with added amino acids), 1000mL bag, Pentec Health Inc., 4 Creek Parkway Suite A, Boothwyn, PA 19061-3132","Compounding Date: 04/30/13 Discard after: 05/21/13",".","1 Bag","Sterility could not be assured for compounded sterile renal nutritional prescriptions.",5/15/2013,"05/15/2013",6/12/2013,"06/12/2013"
"Drugs",65180,"Ongoing","Pentec Health","Boothwyn","PA","US","Voluntary: Firm Initiated","Telephone","Dialysis Centers Direct to patient","D-589-2013","Class II","Proplete 70+ KG (Intraperitoneal Parenteral Nutrition - dialysate solution with added amino acids), in a) 635mL bag and b) 660mL bag, Pentec Health Inc 4 Creek Parkway Suite A Boothwyn, PA 19061-3132 ","Compounding Date: 04/24/13 Discard after: 05/15/13 ",".","38 Bags","Sterility could not be assured for compounded sterile renal nutritional prescriptions.",5/15/2013,"05/15/2013",6/12/2013,"06/12/2013"
"Drugs",65180,"Ongoing","Pentec Health","Boothwyn","PA","US","Voluntary: Firm Initiated","Telephone","Dialysis Centers Direct to patient","D-588-2013","Class II","Proplete 60 - 69 KG (Intradialytic Parenteral Nutrition - dialysate solution with added amino acids), in 555mL bag, Pentec Health Inc, 4 Creek Parkway Suite A Boothwyn, PA 19061-3132","Compounding Date: 04/23/13, 04/24/13, 04/29/13, 05/01/13 Discard after: 05/20/13, 05/22/13 ",".","59 Bags","Lack of Assurance of Sterility: Sterility could not be assured for compounded sterile renal nutritional prescriptions.",5/15/2013,"05/15/2013",6/12/2013,"06/12/2013"
"Drugs",65180,"Ongoing","Pentec Health","Boothwyn","PA","US","Voluntary: Firm Initiated","Telephone","Dialysis Centers Direct to patient","D-587-2013","Class II","Proplete 52 - 59 KG (Intradialytic Parenteral Nutrition - dialysate solution with added amino acids), in a) 485mL bag and b) 490mL bag, Pentec Health Inc 4 Creek Parkway Suite A Boothwyn, PA 19061-3132","Compounding Date: 04/24/13, 04/25/13, 04/29/13 Discard after: 05/15/13, 05/16/13, 05/20/13 ",".","25 Bags","Lack of Assurance of Sterility: Sterility could not be assured for compounded sterile renal nutritional prescriptions.",5/15/2013,"05/15/2013",6/12/2013,"06/12/2013"
"Drugs",65180,"Ongoing","Pentec Health","Boothwyn","PA","US","Voluntary: Firm Initiated","Telephone","Dialysis Centers Direct to patient","D-595-2013","Class II","Baxter LL bag 2% Amino Acids (Intraperitoneal Parenteral Nutrition - dialysate solution with added amino acids), in a) 2500mL bag and b) 6000mL bag, Pentec Health Inc., 4 Creek Parkway Suite A, Boothwyn, PA 19061-3132","Compounding Date: a) 04/26/13, b) 04/30/13 Discard after: a) and b) 5/21/13",".","3 Bags","Lack of Assurance of Sterility: Sterility could not be assured for compounded sterile renal nutritional prescriptions.",5/15/2013,"05/15/2013",6/12/2013,"06/12/2013"
"Drugs",65180,"Ongoing","Pentec Health","Boothwyn","PA","US","Voluntary: Firm Initiated","Telephone","Dialysis Centers Direct to patient","D-590-2013","Class II","Proplete 80+ KG (Intraperitoneal Parenteral Nutrition - dialysate solution with added amino acids), in 710mL bag, Pentec Health Inc., 4 Creek Parkway Suite A Boothwyn, PA 19061-3132 ","Compounding Date: 04/24/13 Discard after: 5/15/13 ",".","1 Bag","Lack of Assurance of Sterility: Sterility could not be assured for compounded sterile renal nutritional prescriptions.",5/15/2013,"05/15/2013",6/12/2013,"06/12/2013"
"Devices",65182,"Ongoing","Cordis Corporation","Miami Lakes","FL","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution - USA (nationwide) and the states of: AZ, CA, CT, FL, GA, IA, IL, LA, MD, MI, MS, NC, NJ, NY, OH, PA, RI, SC, TX, WA, WI, WV, and the countries of: Czech Republic, Italy, Netherlands, and New Zealand","Z-1509-2013","Class II","FLEXSTENT Biliary Self-Expanding Stent System. Product Usage: The FSS FLEXSTENT Biliary SES product is indicated for use in the palliation of malignant strictures in the biliary tree. ","27 Catalog Numbers FLX-50030-B2, FLX-60030-B2, FLX-70030-B2, FLX-80030-B2, FLX-50040-B2, FLX-60040-B2, FLX-70040-B2, FLX-80040-B2, FLX-50060-B2, FLX-60060-B2, FLX-70060-B2, FLX-80060-B2, FLX-50080-B2, FLX-60080-B2, FLX-70080-B2, FLX-80080-B2, FLX-50100-B2, FLX-60100-B2, FLX-70100-B2, FLX-80100-B2, FLX-50120-B2, FLX-60120-B2, FLX-70120-B2, FLX-80120-B2, FLX-60150-B2, FLX-70150-B2, FLX-80150-B2 ",".","1357","Holes and/or tears can be introduced in the FLEXSTENT inner pouch under some conditions, and to a lesser degree, in the outer pouch.",4/23/2013,"04/23/2013",6/12/2013,"06/12/2013"
"Devices",65182,"Ongoing","Cordis Corporation","Miami Lakes","FL","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution - USA (nationwide) and the states of: AZ, CA, CT, FL, GA, IA, IL, LA, MD, MI, MS, NC, NJ, NY, OH, PA, RI, SC, TX, WA, WI, WV, and the countries of: Czech Republic, Italy, Netherlands, and New Zealand","Z-1508-2013","Class II","FLEXSTENT Femoropopliteal Self-Expanding Stent System. Product Usage: The FSS FLEXSTENT Femoropopliteal SES clinical product is indicated for treatment of atherosclerotic de novo native superficial femoral artery lesions and proximal popliteal lesions. ","28 Catalog Numbers CAC-50030-V2, CAC-60030-V2, CAC-70030-V2, CAC-80030-V2, CAC-50040-V2, CAC-60040-V2, CAC-70040-V2, CAC-80040-V2, CAC-50060-V2, CAC-60060-V2, CAC-70060-V2, CAC-80060-V2, CAC-50080-V2, CAC-60080-V2, CAC-70080-V2, CAC-80080-V2, CAC-50100-V2, CAC-60100-V2, CAC-70100-V2, CAC-80100-V2, CAC-50120-V2, CAC-60120-V2, CAC-70120-V2, CAC-80120-V2, CAC-50150-V2, CAC-60150-V2, CAC-70150-V2, CAC-80150-V2 ",".","784","Holes and/or tears can be introduced in the FLEXSTENT inner pouch under some conditions, and to a lesser degree, in the outer pouch.",4/23/2013,"04/23/2013",6/12/2013,"06/12/2013"
"Devices",65182,"Ongoing","Cordis Corporation","Miami Lakes","FL","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution - USA (nationwide) and the states of: AZ, CA, CT, FL, GA, IA, IL, LA, MD, MI, MS, NC, NJ, NY, OH, PA, RI, SC, TX, WA, WI, WV, and the countries of: Czech Republic, Italy, Netherlands, and New Zealand","Z-1510-2013","Class II","FLEXSTENT Femoropopliteal Self-Expanding Stent System. Product Usage: The FSS FLEXSTENT Femoropopliteal SES clinical product is indicated for treatment of atherosclerotic de novo native superficial femoral artery lesions and proximal popliteal lesions. ","32 Catalog Numbers FLX-50030-V1, FLX-60030-V1, FLX-70030-V1, FLX-80030-V1, FLX-50040-V1, FLX-60040-V1, FLX-70040-V1, FLX-80040-V1, FLX-50060-V1, FLX-60060-V1, FLX-70060-V1, FLX-80060-V1, FLX-50080-V1, FLX-60080-V1, FLX-70080-V1, FLX-80080-V1, FLX-50100-V1, FLX-60100-V1, FLX-70100-V1, FLX-80100-V1, FLX-50120-V1, FLX-60120-V1, FLX-70120-V1, FLX-80120-V1, FLX-50150-V1, FLX-60150-V1, FLX-70150-V1, FLX-80150-V1, FLX-50200-V1, FLX-60200-V1, FLX-70200-V1, FLX-80200-V1 ",".","250","Holes and/or tears can be introduced in the FLEXSTENT inner pouch under some conditions, and to a lesser degree, in the outer pouch.",4/23/2013,"04/23/2013",6/12/2013,"06/12/2013"
"Devices",65182,"Ongoing","Cordis Corporation","Miami Lakes","FL","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution - USA (nationwide) and the states of: AZ, CA, CT, FL, GA, IA, IL, LA, MD, MI, MS, NC, NJ, NY, OH, PA, RI, SC, TX, WA, WI, WV, and the countries of: Czech Republic, Italy, Netherlands, and New Zealand","Z-1507-2013","Class II","FLEXSTENT Biliary Self-Expanding Stent System. Product Usage: The FSS FLEXSTENT Biliary SES product is indicated for use in the palliation of malignant strictures in the biliary tree. ","27 Catalog Numbers FLX-50030-B1, FLX-60030-B1, FLX-70030-B1, FLX-80030-B1, FLX-50040-B1, FLX-60040-B1, FLX-70040-B1, FLX-80040-B1, FLX-50060-B1, FLX-60060-B1, FLX-70060-B1, FLX-80060-B1, FLX-50080-B1, FLX-60080-B1, FLX-70080-B1, FLX-80080-B1, FLX-50100-B1, FLX-60100-B1, FLX-70100-B1, FLX-80100-B1, FLX-50120-B1, FLX-60120-B1, FLX-70120-B1, FLX-80120-B1, FLX-60150-B1, FLX-70150-B1, FLX-80150-B1 ",".","23 units","Holes and/or tears can be introduced in the FLEXSTENT inner pouch under some conditions, and to a lesser degree, in the outer pouch.",4/23/2013,"04/23/2013",6/12/2013,"06/12/2013"
"Devices",65182,"Ongoing","Cordis Corporation","Miami Lakes","FL","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution - USA (nationwide) and the states of: AZ, CA, CT, FL, GA, IA, IL, LA, MD, MI, MS, NC, NJ, NY, OH, PA, RI, SC, TX, WA, WI, WV, and the countries of: Czech Republic, Italy, Netherlands, and New Zealand","Z-1511-2013","Class II","FLEXSTENT Femoropopliteal Self-Expanding Stent System. Product Usage: The FSS FLEXSTENT Femoropopliteal SES clinical product is indicated for treatment of atherosclerotic de novo native superficial femoral artery lesions and proximal popliteal lesions. ","32 Catalog Numbers FLX-50030-V2, FLX-60030-V2, FLX-70030-V2, FLX-80030-V2, FLX-50040-V2, FLX-60040-V2, FLX-70040-V2, FLX-80040-V2, FLX-50060-V2, FLX-60060-V2, FLX-70060-V2, FLX-80060-V2, FLX-50080-V2, FLX-60080-V2, FLX-70080-V2, FLX-80080-V2, FLX-50100-V2, FLX-60100-V2, FLX-70100-V2, FLX-80100-V2, FLX-50120-V2, FLX-60120-V2, FLX-70120-V2, FLX-80120-V2, FLX-50150-V2, FLX-60150-V2, FLX-70150-V2, FLX-80150-V2, FLX-50200-V2, FLX-60200-V2, FLX-70200-V2, FLX-80200-V2 ",".","310","Holes and/or tears can be introduced in the FLEXSTENT inner pouch under some conditions, and to a lesser degree, in the outer pouch.",4/23/2013,"04/23/2013",6/12/2013,"06/12/2013"
"Devices",65183,"Ongoing","Baxter Healthcare Corp.","Deerfield","IL","US","Voluntary: Firm Initiated","Letter","US Nationwide Distribution","Z-1682-2013","Class II","Four Lead TUR irrigation Set, for use with UROMATIC Plastic Containers, Product Code 2C4013 - Approximate Length 85'' (2.2. m) Usage: Baxter irrigation sets are intended for the delivery of irrigating solutions from the fluid container to the irrigation site during bladder irrigation or endoscopic procedures including cytoscopy, transurethral resection and arthroscopic procedures. the sets are intended for use with Baxter irrigating solutions in Uromatic or Arthromatic plastic containers. ","UR175554 UR176743 UR182030 UR188144 UR192047 UR192096 UR192260 UR194951 UR202044 UR204032 UR211698 UR214312 UR216069 UR222471 UR225334 UR229294 UR233569 UR233700 UR238915 UR243022 UR246009 UR249383 UR255802 UR260273 UR262980 UR263004 UR265918 UR283580 UR287284 UR288746 UR298216 UR304246 UR307249 UR314328 UR318063 UR321000 UR325464 UR334151 UR339317 UR344234 UR352484 UR352567 UR360255 UR363432 UR366161 UR375857 UR383794 UR385534 UR07J19029 UR07K29059 UR07L21039 UR08B21053 UR08C25151 UR08E15157 UR08G22167 UR08I12065 UR08K13086 UR08L18158 UR09A21211 UR09D02157 UR09E14084 UR09G17125 UR09H26140 UR09J30040 UR09J30065 UR09J30107 UR09L01146 UR10C25033 UR10D09142 UR10E21037 UR10G28129 UR10I28034 UR10L03024 UR10L22024 UR11A14022 UR11B24086 UR11B25125 UR11C25032 UR11F01028 UR11G08088 UR11H08011 UR11H09019 UR11I08043 UR11I23026 UR12A25043 UR12E18502 UR12H03011 UR12H17045 UR12I05030 UR12I06053 UR12I21052 UR12J18040 UR12J26019 UR12L12023 UR13B08053 UR13B15041 UR13C08036 ",".","356,728 units","A firm's internal investigation led to the discovery of pinholes in the packaging of the products. The pinholes are not likely to be detected by the end user prior to use and could compromise the sterile barrier properties of the packaging.",5/15/2013,"05/15/2013",7/17/2013,"07/17/2013"
"Devices",65183,"Ongoing","Baxter Healthcare Corp.","Deerfield","IL","US","Voluntary: Firm Initiated","Letter","US Nationwide Distribution","Z-1683-2013","Class II","Two Lead Arthroscopic Irrigation Set, for use with ARTHROMATIC Plastic Containers, Product Code 2C4030 - Approximate Length 98'' (2.5. m) Usage: Baxter irrigation sets are intended for the delivery of irrigating solutions from the fluid container to the irrigation site during bladder irrigation or endoscopic procedures including cytoscopy, transurethral resection and arthroscopic procedures. the sets are intended for use with Baxter irrigating solutions in Uromatic or Arthromatic plastic containers. ","R06K01067 R06K01075 R06K01083 R07B02013 R07C14065 R07C22035 R07D19088 R07E07015 R07E20935 R07E29050 R07F02063 R07F05025 R07I22065 R07J01019 R07J28012 R07L05073 R08A14027 R08A28019 R08B04026 R08B05031 R08C18040 R08C24022 R08D12066 R08D15085 R08F28075 R08G19122 R08G21029 R08G21037 R08H21019 R08H27065 R08I20076 R08J10175 R08K04010 R08L05205 R09A17060 R09A28109 R09B16086 R09C16100 R09C30119 R09D14012 R09E19026 R09E25122 R09F10148 R09F16087 R09G14072 R09G27025 R09H27080 R09I28094 R09J13103 R09K11154 R09K30014 R09L09032 R09L16227 R10A08264 R10A19188 R10A21630 R10B13122 R10B16158 R10C10118 R10C13096 R10C24044 R10C27179 R10D05041 R10D26047 R10E11087 R10F05152 R10F19054 R10G27014 R10H17211 R10H31212 R10I01106 R10I07129 R10I27036 R10J19024 R10J19149 R10J23067 R10K02226 R10K13066 R10K25029 R10L04071 R10L23048 R11A11010 R11A15078 R11A31224 R11B07172 R11C01223 R11C15157 R11C22294 R11D04167 R11D16062 R11E12159 R11E21077 R11F24103 R11G18020 R11G18103 R11G19077 R11J24189 R11K22140 R11L22114 R12A04113 R12A11134 R12A23113 R12A31124 R12B15117 R12B27070 R12C08144 R12E17116 R12E18056 R12F07057 R12F09087 R12F11067 ",".","530,488 units","A firm's internal investigation led to the discovery of pinholes in the packaging of the products. The pinholes are not likely to be detected by the end user prior to use and could compromise the sterile barrier properties of the packaging.",5/15/2013,"05/15/2013",7/17/2013,"07/17/2013"
"Devices",65183,"Ongoing","Baxter Healthcare Corp.","Deerfield","IL","US","Voluntary: Firm Initiated","Letter","US Nationwide Distribution","Z-1684-2013","Class II"," Four Lead Arthroscopic Irrigation Set, for use with ARTHROMATIC Plastic Containers, Product Code 2C4031 -Approximate Length 99'' (2.5. m) Usage: Baxter irrigation sets are intended for the delivery of irrigating solutions from the fluid container to the irrigation site during bladder irrigation or endoscopic procedures including cytoscopy, transurethral resection and arthroscopic procedures. the sets are intended for use with Baxter irrigating solutions in Uromatic or Arthromatic plastic containers. ","R08D28039 R08D28047 R08D28054 R08H20094 R08H22124 R08H25010 R08H28113 R08I06083 R08I08097 R08I09087 R08J06124 R08J13088 R08K21139 R08K29074 R08L08092 R08L12110 R09A16013 R09A27101 R09A31079 R09B17043 R09B26010 R09C02084 R09C15029 R09D13089 R09E12120 R09E19133 R09F13068 R09F22028 R09G13108 R09H05037 R09H06134 R09H19111 R09I08096 R09I27013 R09J08038 R09J14010 R09J27103 R09J28119 R09K12129 R09L04017 R09L22035 R10A06011 R10A08165 R10A19113 R10A21655 R10B17024 R10C11033 R10C11116 R10C15026 R10D15081 R10D16063 R10D16154 R10D24067 R10E03035 R10G21108 R10G27089 R10H21064 R10H23110 R10I02138 R10I04068 R10I25071 R10J19123 R10J25096 R10K17984 R10K25094 R10L03065 R10L06019 R10L21174 R11B16165 R11B23161 R11C15165 R11C22229 R11D04084 R11D12038 R11E04115 R11E13066 R11E28072 R11E30086 R11F08171 R11H05041 R11H16071 R11H22053 R11I06039 R11I16095 R11I28249 R11J12093 R11J13158 R11J14081 R11K19054 R11K21183 R12A09070 R12A09112 R12B25058 R12C28142 R12E19070 R12E21076 R12E31125 R12F11109 R12F12081 ",".","249,576 units","A firm's internal investigation led to the discovery of pinholes in the packaging of the products. The pinholes are not likely to be detected by the end user prior to use and could compromise the sterile barrier properties of the packaging.",5/15/2013,"05/15/2013",7/17/2013,"07/17/2013"
"Veterinary",65185,"Ongoing","Wedgewood Village Pharmacy, Inc.","Swedesboro","NJ","US","Voluntary: Firm Initiated","Telephone","Nationwide","V-223-2013","Class II","Digoxin (0.09 mg) Capsules, Oral for Veterinary Use Only 100 capsules Packaged in white plastic bottle Store at room temperature Item Code DIGOXI-CAP505VC","Lot 20121023@117, Beyond Use date 10/18/2013 Lot 20121106@197, Beyond Use date 11/01/2013",".",,"Digoxin for veterinary patients is being recalled since potency of medication is less than labeled amount.",3/21/2013,"03/21/2013",7/10/2013,"07/10/2013"
"Veterinary",65185,"Ongoing","Wedgewood Village Pharmacy, Inc.","Swedesboro","NJ","US","Voluntary: Firm Initiated","Telephone","Nationwide","V-222-2013","Class II","Digoxin LS (0.05 mg/mL) Chicken 50 mcg/mL Elixir, Oral for Veterinary Use Only Packaged in 60 mL amber plastic bottle Store at room temperature Item Code: DIGOXI-SOL003VC","Item Code: DIGOXI-SOL0003VC Lot 20130108@042, Beyond Use date 07/07/2013 Lot 20130220@138, Beyond Use date 08/19/2013 ",".",,"Digoxin for veterinary patients is being recalled since potency of medication is less than labeled amount.",3/21/2013,"03/21/2013",7/10/2013,"07/10/2013"
"Veterinary",65185,"Ongoing","Wedgewood Village Pharmacy, Inc.","Swedesboro","NJ","US","Voluntary: Firm Initiated","Telephone","Nationwide","V-221-2013","Class II","1) Digoxin LS (0.05 mg/mL) Liver 50 mcg/mL Elixir, Oral for Veterinary Use Only Various Sizes, Packaged in 60 mL amber plastic bottle Store at room temperature Item Codes DIGOXI-SOL502VC and DIGOXISOL0005VC 2) Digoxin LS (0.15 mg/mL) Liver 150 mcg/mL Elixir, Oral for Veterinary Use Only Various Sizes, Packaged in 60 mL amber plastic bottle Store at room temperature Item Code: DIGOXI-SOL501VC ","Digoxin LS (0.05 mg/mL) Liver 50 mcg/mL: ITEM Code DIGOXI-SOL502VC and DIGOXISOL0005VC Lot 20121002@228, Beyond Use Date 03/31/2013 Lot 20121009@233, Beyond Use Date 04/07/2013 Lot 20121207@062, Beyond Use Date 06/07/2013 Lot 20130107@298, Beyond Use Date 07/06/2013 Lot 20130110@052, Beyond Use Date 07/06/2013 Lot 20130306@086, Beyond Use Date 09/02/2013 ITEM Code DIGOXI-SOL501VC Lot 20121101@195, Beyond Use Date 04/30/2013 ",".",,"Digoxin for veterinary patients is being recalled since potency of medication is less than labeled amount.",3/21/2013,"03/21/2013",7/10/2013,"07/10/2013"
"Veterinary",65185,"Ongoing","Wedgewood Village Pharmacy, Inc.","Swedesboro","NJ","US","Voluntary: Firm Initiated","Telephone","Nationwide","V-224-2013","Class II","a) Digoxin (Flavored) 0.015 mg/mL Suspension, Oral, for Veterinary Use Only 30 mL, Packaged in amber plastic bottle Store at room temperature Item Code DIGOXI-SUS509VC b) Digoxin (Flavored) 0.002 mg/mL Suspension, Oral, for Veterinary Use Only 30 mL, Packaged in amber plastic bottle Store at room temperature Item Code DIGOXI-SUS506VC c) Digoxin (Flavored) 0.075 mg/mL Suspension, Oral, for Veterinary Use Only, Various sizes, Packaged in amber plastic bottle Store at room temperature Item Code DIGOXI-SUS502VC and DIGOXISUS0006VC d) Digoxin (Flavored) 0.1 mg/mL Suspension, Oral, for Veterinary Use Only, Various sizes, Packaged in amber plastic bottle Store at room temperature Item Code DIGOXI-SUS503VC and DIGOXISUS0011VC e) Digoxin (Flavored) 0.125 mg/mL Suspension, Oral, for Veterinary Use Only, 60 mL , Packaged in amber plastic bottle Store at room temperature Item Code DIGOXI-SUS508VC and DIGOXISUS0030VC ","Item Code DIGOXI-SUS509VC Lot 201211022@246, Beyond Use date 05/01/2013 Item Code DIGOXI-SUS506VC Lot 20121025@103 Beyond Use Date 04/23/2013 Item Code DIGOXI-SUS502VC and DIGOXISUS0006VC Lot 20121022@296, Beyond Use Date 04/20/2013 Lot 20121120@307, Beyond Use Date 02/17/2013 Lot 20121207@229, Beyond Use Date 06/05/2013 Item Code DIGOXI-SUS503VC and DIGOXISUS0011VC Lot 20121002@037, Beyond Use Date 03/31/2013 Lot 20121127@313, Beyond Use Date 05/26/2013 Lot 20130103@232, Beyond Use Date 07/02/2013 Lot 20130130@060, Beyond Use Date 07/29/2013 Lot 20130207@032, Beyond Use Date 08/06/2013 Lot 20130304@337, Beyond Use Date 08/31/2013 Lot 20130313@012, Beyond Use Date 09/09/2013 Item Code DIGOXI-SUS508VC and DIGOXISUS0030VC Lot 20121003@015, Beyond Use Date 04/01/2013 Lot 20130219@021, Beyond Use Date 08/18/2013",".",,"Digoxin for veterinary patients is being recalled since potency of medication is less than labeled amount.",3/21/2013,"03/21/2013",7/10/2013,"07/10/2013"
"Food",65186,"Ongoing","Arizona Beverages USA LLC","Woodbury","NY","US","Voluntary: Firm Initiated","E-Mail","CT, PA, NY, NJ, MI, IL and WI.","F-1466-2013","Class III","ORIGINAL BRAND Arizona SOUTHERN STYLE UNSWEETENED Brewed Tea, Net Wt. 128 FL.OZ (1 GAL.). Product is packaged in a cardboard case, each case contains four 1 Gallon plastic containers. UPC Code: 6 1300871981 4. ","Codes: KP 072 13 {1004} CT120. Starting with the time stamp code at 10.04 am and onward",".","8,989 cases (4 containers per case)","Undeclared Splenda ingredient. ",5/15/2013,"05/15/2013",6/12/2013,"06/12/2013"
"Devices",65187,"Ongoing","Microgenics Corporation","Fremont","CA","US","Voluntary: Firm Initiated","Letter","Nationwide Distribution: US including the states of WI, UT, FL NY, PA, IL, CO, AZ and NJ","Z-1563-2013","Class II","Thermo Scientific MAS Bilirubin for Siemens and Dimension Vista Systems, , Product is manufactured and distributed by Microgenics Corporation, Fremont, CA MAS Bilirubin is intended for use as a consistent test sample of known concentration for monitoring assay conditions in many clinical laboratory determinations. Includes Bilirubin with patient serum specimens when assaying for any of the listed constituents. Assay values are provided for the specific systems listed. The user can compare observations with expected ranges as a means of assuring consistent performance of reagent and instrument.","Catalog Number: 10014432; Lot Numbers: 1MQ310, Expiration Date: 31 Dec 2013, 2CQ310, Expiration Date: 31 Mar 2014, 2KQ310, Expiration Date: 31 Oct 2014 ",,"188","It has been confirmed from in-house testing that Direct Bilirubin (DBIL), and Total Bilirubin (TBIL) claimed in Thermo Scientific MAS Bilirubin Systems are displaying reduced stability.",5/13/2013,"05/13/2013",7/3/2013,"07/03/2013"
"Devices",65188,"Ongoing","Siemens Healthcare Diagnostics, Inc. ","West Sacramento","CA","US","Voluntary: Firm Initiated","Letter","Nationwide Distribution.","Z-1525-2013","Class II","Siemens brand MicroScan Dried Negative Breakpoint Combo 47 panels (B1017-417), SMN #: 10483099), For use in determining quantitative and/or qualitative antimicrobial agent susceptibility. ","Lot: 2013-11-13, Exp 11/13/2013.",".","683 units","The product has the potential for false negative or delayed reaction for Arginine (ARG) results. In addition, 42 hour identification panel holds may occur due to a weak ARG reaction.",5/2/2013,"05/02/2013",6/19/2013,"06/19/2013"
"Biologics",65189,"Terminated","TissueTech, Inc. dba Bio-Tissue, Inc.","Miami","FL","US","Voluntary: Firm Initiated","Telephone","Nevada; Illinois; New Mexico; Arizona; Alabama; Oregon; Ohio; Florida; California; Washington; Louisiana; Texas","B-1847-13","Class II","Amniotic membrane","2012AG1510F06969, 2012AG1510F06970, 2012AG1510F06974, 2012AG1510F06976, 2012AG1510F06977, 2012AG1510F06979, 2012AG1510F06980, 2012AG1510F06981, 2012AG1510F06984, 2012AG1510F06988, 2012AG1510F06991, 2012AG1510F06992, 2012AG1510F06994, 2012AG1510F07000, 2012AG1510F07001, 2012AG1510F07002, 2012AG1510F07005, 2012AG1510F07007, 2012AG1510F07008, 2012AG1510F07010, 2012AG1510F07011, 2012AG1510F07012, 2012AG1510F07019, 2012AG1510F07020, 2012AG1510F07021, 2012AG1510F07025, 2012AG1510F07026, 13NX10252500019, 2012AG1510F06978, 2012AG1510F06993, 2012AG1510F07003, 2012AG1510F07004, 2012AG1510F07014, 2012AG1510F07015, 2012AG1510F07016, 2012AG1510F07017, 2012AG1510F07018, 2012AG1510F06971, 2012AG1510F06972, 2012AG1510F06973, 2012AG1510F06975, 2012AG1510F06982, 2012AG1510F06983, 2012AG1510F06985, 2012AG1510F06986, 2012AG1510F06987, 2012AG1510F06989, 2012AG1510F06990, 2012AG1510F06995, 2012AG1510F06997, 2012AG1510F06998, 2012AG1510F06999, 2012AG1510F07006, 2012AG1510F07009, 2012AG1510F07013, 2012AG1510F07022, 2012AG1510F07023, 2012AG1510F07024 ",".","58","Amniotic membrane allografts, not tested adequately and appropriately to reduce the risk of transmission of relevant communicable diseases, were distributed. ",3/18/2013,"03/18/2013",7/17/2013,"07/17/2013"
"Biologics",65189,"Terminated","TissueTech, Inc. dba Bio-Tissue, Inc.","Miami","FL","US","Voluntary: Firm Initiated","Telephone","Nevada; Illinois; New Mexico; Arizona; Alabama; Oregon; Ohio; Florida; California; Washington; Louisiana; Texas","B-1846-13","Class III","Amniotic membrane","12NX10252500519, 12NX10252500520",".","2","Amniotic membrane allografts, not tested adequately and appropriately to reduce the risk of transmission of relevant communicable diseases, were distributed. ",3/18/2013,"03/18/2013",7/17/2013,"07/17/2013"
"Devices",65191,"Ongoing","Optovue, Inc.","Fremont","CA","US","Voluntary: Firm Initiated","Letter","Distributed Nationwide and in Canada.","Z-1441-2013","Class III","Optovue iVue with Normative Database (NDB) with Software Version 3.0 and 3.1. Intended for in vivo imaging.","iVue software version 3.0 and 3.1 3.1 is international version, only distributed to Canada but not currently installed in any Canadian facilities.",".","~329 users","Colors from the NDB comparison for Ganglion Cell Complex thickness in the singular OU report in iVue version 3.0 (US) and 3.1(international) are different from those in the individual iWellness ID and OS reports.",5/14/2013,"05/14/2013",6/12/2013,"06/12/2013"
"Devices",65192,"Ongoing","Symbios Medical Products, LLC","Indianapolis","IN","US","Voluntary: Firm Initiated","Letter","nationwide USA,","Z-1461-2013","Class I","Part 510613 Disposable Infusion Pump, ...Elastomeric Pump 300mL (150 mL side)( 6mL/hr ),... found in the following kits GoBlock Kit 510612, Disposable Infusion Pump for drug delivery. Symbios GOBlock System is a disposable, self contained infusion system. ","Pump Part 510613 , Lot 11-100815 - Lot 12-10101060 found in: GoBlock Kit 510612, Lot 11-100817 to 13-101475",".","33,543 all kits","Symbios Medical Products, Indianapolis, Indiana, is performing a voluntary recall of all GoPumps found in the GoPump Rapid Recovery System kits and all GoBlock kits manufactured with flow control components assembled prior to July 2012. The recall is being expanded after receiving additional reports relating to excessively high flow rates on the 150 mL reservoir, 2 mL/hr GOPump (PN510031), and the 300 mL (dual reservoir), 2 mL/hr GOPump (PN510076). To date, there have been 5 complaints received, 2 of which involved serious injury. There have been no patient deaths reported. The risk of patient toxicity due to the rapid influx of medication include seizure, dysrhythmia, and death.",5/10/2013,"05/10/2013",6/12/2013,"06/12/2013"
"Devices",65192,"Ongoing","Symbios Medical Products, LLC","Indianapolis","IN","US","Voluntary: Firm Initiated","Letter","nationwide USA,","Z-1460-2013","Class I","Part 510613 Disposable Infusion Pump, ...Elastomeric Pump 300mL (150 mL side)( 6mL/hr ),... found in the following kits GoBlock Kit 510612, Disposable Infusion Pump for drug delivery. Symbios GOBlock System is a disposable, self contained infusion system. ","Pump Part 510613 , Lot 11-100136- Lot 12-10101060 found in: GoBlock Kit 510612, Lot 11-100817 to 13-101475",".","33,543 all kits","Symbios Medical Products, Indianapolis, Indiana, is performing a voluntary recall of all GoPumps found in the GoPump Rapid Recovery System kits and all GoBlock kits manufactured with flow control components assembled prior to July 2012. The recall is being expanded after receiving additional reports relating to excessively high flow rates on the 150 mL reservoir, 2 mL/hr GOPump (PN510031), and the 300 mL (dual reservoir), 2 mL/hr GOPump (PN510076). To date, there have been 5 complaints received, 2 of which involved serious injury. There have been no patient deaths reported. The risk of patient toxicity due to the rapid influx of medication include seizure, dysrhythmia, and death.",5/10/2013,"05/10/2013",6/12/2013,"06/12/2013"
"Devices",65192,"Ongoing","Symbios Medical Products, LLC","Indianapolis","IN","US","Voluntary: Firm Initiated","Letter","nationwide USA,","Z-1458-2013","Class I","Part 510450 Disposable Infusion Pump, ...Elastomeric Pump 600 mL( 10mL/hr ),... found in the following kits GoBlock Kit 510458, Disposable Single Infusion Pump ","Pump Part 510450, Lot 11-100351- Lot 12-101243 found in: GoBlock Kit 510458, Lot 11-100618 to 13-100703 ",".","33, 543 for all kits","Symbios Medical Products, Indianapolis, Indiana, is performing a voluntary recall of all GoPumps found in the GoPump Rapid Recovery System kits and all GoBlock kits manufactured with flow control components assembled prior to July 2012. The recall is being expanded after receiving additional reports relating to excessively high flow rates on the 150 mL reservoir, 2 mL/hr GOPump (PN510031), and the 300 mL (dual reservoir), 2 mL/hr GOPump (PN510076). To date, there have been 5 complaints received, 2 of which involved serious injury. There have been no patient deaths reported. The risk of patient toxicity due to the rapid influx of medication include seizure, dysrhythmia, and death.",5/10/2013,"05/10/2013",6/12/2013,"06/12/2013"
"Devices",65192,"Ongoing","Symbios Medical Products, LLC","Indianapolis","IN","US","Voluntary: Firm Initiated","Letter","nationwide USA,","Z-1456-2013","Class I","Part510447 Disposable Infusion Pump, ...Elastomeric Pump 600 mL, 2mL/hr/side,... found in the following kits GoPump Kit 510462-BP, 5 '' catheter & BIOPATCH GoPump Kit 510558-BP 10 '' catheter& BIOPATCH GoPump Kit 64310 Disposable Single Infusion Pump. Symbios GOPump Rapid Recovery System is a local pain mangagement system that consists of a small balloon that is inflated with a local anesthetic medication. ","GoPump Kit 510462-BP, Lot 11-100694- Lot 13-100092 GoPump Kit 510558-BP , Lot 12-100230 - Lot12-101343 GoPump Kit 510643, Lot 12-100332 - Lot 13-100183",".","34517 for all kits","Symbios Medical Products, Indianapolis, Indiana, is performing a voluntary recall of all GoPumps found in the GoPump Rapid Recovery System kits and all GoBlock kits manufactured with flow control components assembled prior to July 2012. The recall is being expanded after receiving additional reports relating to excessively high flow rates on the 150 mL reservoir, 2 mL/hr GOPump (PN510031), and the 300 mL (dual reservoir), 2 mL/hr GOPump (PN510076). To date, there have been 5 complaints received, 2 of which involved serious injury. There have been no patient deaths reported. The risk of patient toxicity due to the rapid influx of medication include seizure, dysrhythmia, and death.",5/10/2013,"05/10/2013",6/12/2013,"06/12/2013"
"Devices",65192,"Ongoing","Symbios Medical Products, LLC","Indianapolis","IN","US","Voluntary: Firm Initiated","Letter","US Nationwide distribution.","Z-1452-2013","Class I","Part 510031 Disposable Single Infusion Pump, quantity Includes... TOTAL VOLUME: 150mL, 2 mL/hr continuous Delivery Time : App. 72 hrs when filled to capacity Sterile EO... found in the following GoPump Kits: GoPump Kit 510042, w/ Epidural Catheter GoPump Kit 510042 - BP, w/ Epidural Catheter, BIOPATCH GoPump Kit 510110, w/2.5'' Fenestrated Catheter GoPumpKit 510110-BP, w/2.5'' Fenestrated Catheter,BioPatch GoPumpKit 510350 w/ Epidural Catheter GoPump Kit 510350-BP w/ Epidural Catheter, BIOPATCH GoPumpKit 510556-BP , 2.5 catheter, BIOPATCH Symbios GOPump Rapid Recovery System is a local pain mangagement system that consits of a small balloon that is inflated with a local anesthetic medication. ","Pump 510031, Lot 11-l 00106 to Lot 12-101133 Kit 510042, lots 11-100251 to 13-100128 Kit 510042-BP , lot 12-101300 Kit 510110, lot 11-100664 Kit 510110-BP, Lots 11-100838 to 12-101560 Kit 510350, Lots 11-100353 to 12-100233 Kit 510350-BP, Lots12-100429 to 13-100047 Kit 510556-BP Lots 11-100779 to 12-101552 ","."," 33, 543 in all sizes/ kits","Symbios Medical Products, Indianapolis, Indiana, is performing a voluntary recall of all GoPumps found in the GoPump Rapid Recovery System kits and all GoBlock kits manufactured with flow control components assembled prior to July 2012. The recall is being expanded after receiving additional reports relating to excessively high flow rates on the 150 mL reservoir, 2 mL/hr GOPump (PN510031), and the 300 mL (dual reservoir), 2 mL/hr GOPump (PN510076). To date, there have been 5 complaints received, 2 of which involved serious injury. There have been no patient deaths reported. The risk of patient toxicity due to the rapid influx of medication include seizure, dysrhythmia, and death.",5/10/2013,"05/10/2013",6/12/2013,"06/12/2013"
"Devices",65192,"Ongoing","Symbios Medical Products, LLC","Indianapolis","IN","US","Voluntary: Firm Initiated","Letter","nationwide USA,","Z-1455-2013","Class I","Part 510121 Disposable Infusion Pump, ...Elastomeric Pump 300 mL, 4mL/hr,...sterile.. found in the following kits GoPump Kit 510203-BP, Epidural catheter & BIOPATCH GoPump Kit 510204, 2.5'' Fenestrated catheter GoPump Kit 510204 BP, 2.5 Fenestrated catheter & Biopatch GoPump Kit 510205BP, 5'' Fenestrated catheter & Biopatch GoPump Kit 510551-BP, 2.5 Fenestrated catheter & Biopatch GoBlock kit 510608 Disposable Single Infusion Pump; Symbios GOPump Rapid Recovery System is a local pain mangagement system that consists of a small balloon that is inflated with a local anesthetic medication. ","Pump Part 510121, Lot 11-100081 to 12-101406 found in: Go Pump Kit 510203-BP. Lot 12-101301 to 13-101538 GoPump Kit 510204, Lot 11-100505 to 11-1-665 GoPump Kit 510204 BP, Lot 11-100721 to 13-100680 GoPump Kit 510205BP, Lot 11-100722 to 13-100087 GoBlock kit 510608",".","33,543 in all kits","Symbios Medical Products, Indianapolis, Indiana, is performing a voluntary recall of all GoPumps found in the GoPump Rapid Recovery System kits and all GoBlock kits manufactured with flow control components assembled prior to July 2012. The recall is being expanded after receiving additional reports relating to excessively high flow rates on the 150 mL reservoir, 2 mL/hr GOPump (PN510031), and the 300 mL (dual reservoir), 2 mL/hr GOPump (PN510076). To date, there have been 5 complaints received, 2 of which involved serious injury. There have been no patient deaths reported. The risk of patient toxicity due to the rapid influx of medication include seizure, dysrhythmia, and death.",5/10/2013,"05/10/2013",6/12/2013,"06/12/2013"
"Devices",65192,"Ongoing","Symbios Medical Products, LLC","Indianapolis","IN","US","Voluntary: Firm Initiated","Letter","nationwide USA,","Z-1457-2013","Class I","Part 510449 Disposable Infusion Pump, ...Elastomeric Pump 600 mL( 8mL/hr ),... found in the following kits GoBlock Kit 510472, Disposable Single Infusion Pump. Symbios GOPump Rapid Recovery System is a local pain mangagement system that consists of a small balloon that is inflated with a local anesthetic medication.","Pump Part 510449, Lot 11-100271 - Lot 130100137 found in: GoBlock Kit 510472, Lot 11-100385 to 13-100354 ",".",,"Symbios Medical Products, Indianapolis, Indiana, is performing a voluntary recall of all GoPumps found in the GoPump Rapid Recovery System kits and all GoBlock kits manufactured with flow control components assembled prior to July 2012. The recall is being expanded after receiving additional reports relating to excessively high flow rates on the 150 mL reservoir, 2 mL/hr GOPump (PN510031), and the 300 mL (dual reservoir), 2 mL/hr GOPump (PN510076). To date, there have been 5 complaints received, 2 of which involved serious injury. There have been no patient deaths reported. The risk of patient toxicity due to the rapid influx of medication include seizure, dysrhythmia, and death.",5/10/2013,"05/10/2013",6/12/2013,"06/12/2013"
"Devices",65192,"Ongoing","Symbios Medical Products, LLC","Indianapolis","IN","US","Voluntary: Firm Initiated","Letter","nationwide USA,","Z-1454-2013","Class I","Part 510180 Disposable Single Infusion Pump, ... Elastomeric Pump 300 mL, 2mL/hr,... found in : GoPump Kit 510201-BP, 5 fenestrated catheter & BIOPATCH; Go Pump Kit 510349-BP, Epidural Catheter, BioPatch; Go Pump Kit 510642 Disposable Single Infusion Pump, Symbios GOPump Rapid Recovery System is a local pain mangagement system that consists of a small balloon that is inflated with a local anesthetic medication. The medication is delivered via tubing to the surgical site at a very slow rate","Pump Part 510180, Lot 11-100453 to 12-101003 found in: Go Pump Kit 510201-BP. Lot 12-100108 to 12-101538 Go Pump Kit 510349-BP. Lot 12-100935 Go Pump Kit 510642, Lot 12-100616 to 13-100590",".","all kits 33, 543","Symbios Medical Products, Indianapolis, Indiana, is performing a voluntary recall of all GoPumps found in the GoPump Rapid Recovery System kits and all GoBlock kits manufactured with flow control components assembled prior to July 2012. The recall is being expanded after receiving additional reports relating to excessively high flow rates on the 150 mL reservoir, 2 mL/hr GOPump (PN510031), and the 300 mL (dual reservoir), 2 mL/hr GOPump (PN510076). To date, there have been 5 complaints received, 2 of which involved serious injury. There have been no patient deaths reported. The risk of patient toxicity due to the rapid influx of medication include seizure, dysrhythmia, and death.",5/10/2013,"05/10/2013",6/12/2013,"06/12/2013"
"Devices",65192,"Ongoing","Symbios Medical Products, LLC","Indianapolis","IN","US","Voluntary: Firm Initiated","Letter","nationwide USA,","Z-1459-2013","Class I","Part 510490 Disposable Infusion Pump, ...Elastomeric Pump 600 mL( 300 ml per side)( 6mL/hr ),... found in the following kits GoBlock Kit 510491, Disposable Single Infusion Pump for drug delivery","Pump Part 510490, Lot 11-100379- Lot 12-101132 found in: GoBlock Kit 510491, Lot 11-100601 to 13-100705",".","33, 543 for all kits","Symbios Medical Products, Indianapolis, Indiana, is performing a voluntary recall of all GoPumps found in the GoPump Rapid Recovery System kits and all GoBlock kits manufactured with flow control components assembled prior to July 2012. The recall is being expanded after receiving additional reports relating to excessively high flow rates on the 150 mL reservoir, 2 mL/hr GOPump (PN510031), and the 300 mL (dual reservoir), 2 mL/hr GOPump (PN510076). To date, there have been 5 complaints received, 2 of which involved serious injury. There have been no patient deaths reported. The risk of patient toxicity due to the rapid influx of medication include seizure, dysrhythmia, and death.",5/10/2013,"05/10/2013",6/12/2013,"06/12/2013"
"Devices",65192,"Ongoing","Symbios Medical Products, LLC","Indianapolis","IN","US","Voluntary: Firm Initiated","Letter","nationwide USA,","Z-1453-2013","Class I","Part 510076 Disposable Dual Infusion Pump, ...Elastomeric Dual Pump 300 mL(150 ml/side) 2mL/hr/side,... Sterile, found in the following kits: GoPump kit 510080-BP, 5 fenestrated catheter & BIOPATCH; GoPump kit 510112-BP, 2.5'' fenestrated catheter & BIOPATCH Go Pump Kit 510141-BP,10'' fenestrated catheter& BIOPATCH Disposable Single Infusion Pump for drug delivery Symbios GOPump Rapid Recovery System is a local pain mangagement system that consists of a small balloon that is inflated with a local anesthetic medication. ","Pump 510076 Lot 11-100222 to 12-101087 found in: Kit 510080 BP. Lot 11-100215 to 12-100508 Kit 510141-BP Lot 12-100460 to 12-100673 Kit 510112-BP, Lot 11-100839-to 13-100225",".","all kits 33,543","Symbios Medical Products, Indianapolis, Indiana, is performing a voluntary recall of all GoPumps found in the GoPump Rapid Recovery System kits and all GoBlock kits manufactured with flow control components assembled prior to July 2012. The recall is being expanded after receiving additional reports relating to excessively high flow rates on the 150 mL reservoir, 2 mL/hr GOPump (PN510031), and the 300 mL (dual reservoir), 2 mL/hr GOPump (PN510076). To date, there have been 5 complaints received, 2 of which involved serious injury. There have been no patient deaths reported. The risk of patient toxicity due to the rapid influx of medication include seizure, dysrhythmia, and death.",5/10/2013,"05/10/2013",6/12/2013,"06/12/2013"
"Devices",65192,"Ongoing","Symbios Medical Products, LLC","Indianapolis","IN","US","Voluntary: Firm Initiated","Letter","US Nationwide distribution.","Z-1462-2013","Class I","Part 510636 Disposable Infusion Pump, ...Elastomeric Pump 600 mL( 300 ml perside), 2 to 10 ml/hr. Delivery time 60 to 144 hours; found in the following kits: GoBlock Kit 510646, Disposable Infusion Pump for drug delivery. Symbios GOBlock System is a disposable, self contained infusion system. ","Pump Part 510636 , Lot 11-100632- Lot 12-101233 found in: GoBlock Kit 510646, Lot 11-100632- Lot 12-101233 ",".","33543","Symbios Medical Products, Indianapolis, Indiana, is performing a voluntary recall of all GoPumps found in the GoPump Rapid Recovery System kits and all GoBlock kits manufactured with flow control components assembled prior to July 2012. The recall is being expanded after receiving additional reports relating to excessively high flow rates on the 150 mL reservoir, 2 mL/hr GOPump (PN510031), and the 300 mL (dual reservoir), 2 mL/hr GOPump (PN510076). To date, there have been 5 complaints received, 2 of which involved serious injury. There have been no patient deaths reported. The risk of patient toxicity due to the rapid influx of medication include seizure, dysrhythmia, and death.",5/10/2013,"05/10/2013",6/12/2013,"06/12/2013"
"Devices",65193,"Ongoing","Prism Medical Services USA","Maryland Heights","MO","US","Voluntary: Firm Initiated","Letter","Worldwide distribution: US (nationwide) and country of: Canada.","Z-1578-2013","Class II","Prism Medical C-Series Carry Bar, Class I, model number 360755. The intended use is a carry bar attached to a C-450 or C-625 ceiling lift used to lift, transfer or position clients.","model number 360755",,"1131 carry bars/New England","The firm replaced the recalled carry bar with a plastic insert with a carry bar with a metal insert due to improper installation of the recalled carry bars.",1/27/2013,"01/27/2013",7/3/2013,"07/03/2013"
"Devices",65194,"Ongoing","Intuitive Surgical, Inc.","Sunnyvale","CA","US","Voluntary: Firm Initiated",,"Worldwide Distribution-USA (nationwide) including the states of AL, CA, CO, FL, IL, KY, MI, MS, NJ, NY, PA, TX, UT, VA, WA, and WI, and the countries of Austria, Australia, Belgium, Canada, Czech Republic, Denmark, France, Germany, Italy, Netherlands, Norway, Qatar, Romania, Spain, Sweden, Switzerland, Taiwan, United Kingdom, Saudi Arabia, Singapore, and Venezuela.","Z-1432-2013","Class II","8mm Maryland Bipolar Forceps used in conjunction with the da Vinci S Surgical System, Model IS1200. Multiple use electrosurgical endoscopic instruments. ","Model number: 400172-08; Lot numbers: M10120815 M10120817 M10120831 M10120913 M10120918 M10121008 M10121024 M10121120 M10121123 M10121203 M10121210 M10121215 M10130220 M10130222 M10130311 M10130315 M10130327 M10130411. ",".","697 - all products","Reports of dislodging of the Cautery Plug Insert from the Cautery Plug Riser, preventing a bipolar cautery cable from being properly connected which results in loss of cautery function of Bipolar Instruments. ",5/8/2013,"05/08/2013",6/5/2013,"06/05/2013"
"Devices",65194,"Ongoing","Intuitive Surgical, Inc.","Sunnyvale","CA","US","Voluntary: Firm Initiated",,"Worldwide Distribution-USA (nationwide) including the states of AL, CA, CO, FL, IL, KY, MI, MS, NJ, NY, PA, TX, UT, VA, WA, and WI, and the countries of Austria, Australia, Belgium, Canada, Czech Republic, Denmark, France, Germany, Italy, Netherlands, Norway, Qatar, Romania, Spain, Sweden, Switzerland, Taiwan, United Kingdom, Saudi Arabia, Singapore, and Venezuela.","Z-1431-2013","Class II","8mm Precise Bipolar Forceps used in conjunction with the da Vinci S Surgical System, Model IS1200. Multiple use electrosurgical endoscopic instruments. ","Model number: 400110-10; Lot numbers: M10120807 M10120817 M10120831 M10120910 M10121008 M10121012 M10121024 M10121115 M10121123 M10121130 M10121206 M10121210 M10130124 M10130131 M10130205 M10130304 M10130319 M10130321 ",".","697 units - all products","Reports of dislodging of the Cautery Plug Insert from the Cautery Plug Riser, preventing a bipolar cautery cable from being properly connected which results in loss of cautery function of Bipolar Instruments. ",5/8/2013,"05/08/2013",6/5/2013,"06/05/2013"
"Devices",65194,"Ongoing","Intuitive Surgical, Inc.","Sunnyvale","CA","US","Voluntary: Firm Initiated",,"Worldwide Distribution-USA (nationwide) including the states of AL, CA, CO, FL, IL, KY, MI, MS, NJ, NY, PA, TX, UT, VA, WA, and WI, and the countries of Austria, Australia, Belgium, Canada, Czech Republic, Denmark, France, Germany, Italy, Netherlands, Norway, Qatar, Romania, Spain, Sweden, Switzerland, Taiwan, United Kingdom, Saudi Arabia, Singapore, and Venezuela.","Z-1433-2013","Class II","8mm Fenestrated Bipolar Forceps used in conjunction with the da Vinci S Surgical System, Model IS1200. Multiple use electrosurgical endoscopic instruments. ","Model number: 400205-04; Lot numbers: M10120816 M10120820 M10120903 M10120910 M10120912 M10120921 M10121008 M10121024 M10121120 M10121130 M10121206 M10121213 M10121215 M10130124 M10130131 M10130213 M10130218 M10130222 M10130313 M10130319 M10130402. ",".","697 - all products","Reports of dislodging of the Cautery Plug Insert from the Cautery Plug Riser, preventing a bipolar cautery cable from being properly connected which results in loss of cautery function of Bipolar Instruments. ",5/8/2013,"05/08/2013",6/5/2013,"06/05/2013"
"Drugs",65196,"Ongoing","Apotex Corp.","Weston","FL","US","Voluntary: Firm Initiated","Letter","Nationwide","D-835-2013","Class I","Piperacillin and Tazobactam for Injection, USP, 40.5 grams per Pharmacy Bulk Package vial, Rx only, Mfg. by: Hospira Healthcare India Pvt. Ltd., Irungattukottai - 602 105, India; Mfg. for: Apotex Corp., Weston, FL 33326, NDC 60505-0773-0","Lot No. 503B023, Exp. 08/13; 503B028, 503B029, 503B030, 503B031, 503B032, 503B033, Exp. 11/13; 503C001, 503C002, 503C003, 503C004, Exp. 12/13; 503C009, Exp. 01/14; 503C010, 503C011, 503C012, 503C014, Exp. 02/14; 503C015, 503C016, 503C017, 503C019, 503C020, Exp. 04/14",".","52,398 vials","Crystallization: Potential to exhibit precipitation/crystallization in IV bag or IV line upon reconstitution.",5/10/2013,"05/10/2013",8/14/2013,"08/14/2013"
"Biologics",65197,"Terminated","Mississippi Blood Services Inc.","Flowood","MS","US","Voluntary: Firm Initiated","FAX","Tennessee","B-1998-13","Class III","Red Blood Cells Leukocytes Reduced","W069111115072",,"1 unit","Blood products, which were collected from a donor in which donor suitability was not adequately determined, were distributed.",4/23/2013,"04/23/2013",7/31/2013,"07/31/2013"
"Biologics",65198,"Terminated","LifeServe Blood Center","Des Moines","IA","US","Voluntary: Firm Initiated","Telephone","New Jersey","B-1999-13","Class II","Platelets Pheresis Leukocytes Reduced","W037913559084(Part A); W037913559084(Part B)",,"2 units","Blood products, in which quality control and distribution of products did not meet specifications, were distributed.",4/15/2013,"04/15/2013",7/31/2013,"07/31/2013"
"Biologics",65199,"Terminated","Carter BloodCare/ WE & Lela I Stewart Blood Center, Inc","Tyler","TX","US","Voluntary: Firm Initiated","Letter","Texas","B-2000-13","Class II","Red Blood Cells (Apheresis) Leukocytes Reduced","W035212218081F(Part A); W035212218081F(Part B)",,"2 units","Blood products, which were collected from a donor in which donor suitability was not adequately determined, were distributed.",3/1/2013,"03/01/2013",7/31/2013,"07/31/2013"
"Drugs",65200,"Ongoing","Sandoz Incorporated","Broomfield","CO","US","Voluntary: Firm Initiated","Press Release","Nationwide","D-832-2013","Class I","Methotrexate Injection, USP, Preservative-Free, 1 g/40 mL (25 mg/mL), 40 mL Single Dose Vial, Rx only, Manufactured for: Sandoz Inc., Princeton, NJ 08540; Manufactured by: EBEWE Pharma Ges.m.b.H. Nfg.KG, A-4866 Unterach, AUSTRIA, NDC 66758-041-01.","Lot #: CL0996, Exp 12/13; and CJ4948, Exp 05/13",".","1,635 vials","Presence of Particulate Matter: Found during examination of retention samples.",5/20/2013,"05/20/2013",8/14/2013,"08/14/2013"
"Food",65201,"Completed","Berkshire Cheese LLC","Great Barrington","MA","US","Voluntary: Firm Initiated","email","MA","F-1530-2013","Class III","Berkshire Blue Cheese, Made from Whole Unpasteurized Cow's' Milk. Aged 60 days Unit size: 2-3 Lb. wheels Wrapped in wax paper then plastic ","Batch HZ",".","149 lbs","E. Coli contamination (non pathogenic)",5/3/2013,"05/03/2013",6/19/2013,"06/19/2013"
"Devices",65202,"Ongoing","Bard Access Systems","Salt Lake City","UT","US","Voluntary: Firm Initiated","Letter","National and Global distribution (Europe, European Economic Area, Argentina, China, and Brazil).","Z-1618-2013","Class II","StatLock CV Plus w/Pigtail, Catheter Stabilization Device Sterile EO Single Use Only, C.R. Bard, Inc. The StatLock device provides stabilization for compatible medical tubes and catheters.","Lot JUWJF283",".","3,875 units.","BARD Access Systems is recalling lot JUWJF283 of StatLock CV Plus Stabilization Butterfly Devices due to incorrect pad assembly used during manufacture. The absence of the hydrocolloid strip on the bottom may pose an incremental risk including localized skin irritation. Missing directional arrow may lead to mis-orientation of the StatLock stabilization which may impact the securement of the catheter.",6/10/2013,"06/10/2013",7/10/2013,"07/10/2013"
"Food",65203,"Ongoing","Tropical Valley Foods, Inc.","Plattsburgh","NY","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Michigan, Oregon, Colorado, and New Jersey","F-1458-2013","Class I","next by Nature brand DARK CHOCOLATE BANANAS, NET WT. 3 Oz. (85g), UPC 8 17582 25600 4, Produced by Tropical Valley Foods","''Best by Date'' of 12/18/2013 and 12/19/2013",".",,"The product contains the undeclared allergens walnuts and milk. ",4/12/2013,"04/12/2013",6/5/2013,"06/05/2013"
"Food",65204,"Ongoing","Eco-Cuisine","boulder","CO","US","Voluntary: Firm Initiated","Telephone","Nation wide distribution and Canada.","F-1623-2013","Class II","Eco-Cuisine Reduced Sodium ''Sausage Style'' Quick Mix, SKU: AA10SGQM, Pack size 10 lb bag, 1 bags per case, Distributed by Eco-Cuisine and manufactured by All American Seasonings, Denver, CO.","Item number T3394 all lots.",".","1,911 lbs","Eco-Cuisine is recalling certain spice/baking mixes due to potential contamination with salmonella as reported by their raw materials supplier.",5/16/2013,"05/16/2013",7/17/2013,"07/17/2013"
"Food",65204,"Ongoing","Eco-Cuisine","boulder","CO","US","Voluntary: Firm Initiated","Telephone","Nation wide distribution and Canada.","F-1628-2013","Class II","Eco-Cuisine Cookie Mix, SKU: CM25COOK, Pack size 25 lb bag, Distributed by Eco-Cuisine and manufactured by Central Milling.","Item number CM25COOK all lots.",".","2,450 lbs","Eco-Cuisine is recalling certain spice/baking mixes due to potential contamination with salmonella as reported by their raw materials supplier.",5/16/2013,"05/16/2013",7/17/2013,"07/17/2013"
"Food",65204,"Ongoing","Eco-Cuisine","boulder","CO","US","Voluntary: Firm Initiated","Telephone","Nation wide distribution and Canada.","F-1626-2013","Class II","Eco-Cuisine English Scone Mix, SKU: AA01SCON, Pack size 1 lb bag, 10 bags per case, Distributed by Eco-Cuisine and manufactured by All American Seasonings, Denver, CO.","Item number T3418 all lots.",".","1,005 lbs","Eco-Cuisine is recalling certain spice/baking mixes due to potential contamination with salmonella as reported by their raw materials supplier.",5/16/2013,"05/16/2013",7/17/2013,"07/17/2013"
"Food",65204,"Ongoing","Eco-Cuisine","boulder","CO","US","Voluntary: Firm Initiated","Telephone","Nation wide distribution and Canada.","F-1621-2013","Class II","Eco-Cuisine Chocolate Brownie Mix, SKU: AA01BRWN, Pack size 1 lb bag, 10 bags per case, and SKU: AA25BRWN 25 lbs bulk bag, Distributed by Eco-Cuisine and manufactured by All American Seasonings, Denver, CO.","Item number T3314 all lots.",".","5,050 lbs","Eco-Cuisine is recalling certain spice/baking mixes due to potential contamination with salmonella as reported by their raw materials supplier.",5/16/2013,"05/16/2013",7/17/2013,"07/17/2013"
"Food",65204,"Ongoing","Eco-Cuisine","boulder","CO","US","Voluntary: Firm Initiated","Telephone","Nation wide distribution and Canada.","F-1622-2013","Class II","Eco-Cuisine Reduced Sodium ''Ground Beef Style'' Quick Mix, SKU: AA10GBQM, Pack size 10 lb bag, 1 bags per case, Distributed by Eco-Cuisine and manufactured by All American Seasonings, Denver, CO; and TV10GBQM 10 lb bag distributed by Eco-Cuisine and manufactured by TOVA, Louisville, KY.","SKU: AA10GBQM, item number T3388 all lots, SKU: TV10GBQM, lot 26122481A. ",".","6,971 lbs","Eco-Cuisine is recalling certain spice/baking mixes due to potential contamination with salmonella as reported by their raw materials supplier.",5/16/2013,"05/16/2013",7/17/2013,"07/17/2013"
"Food",65204,"Ongoing","Eco-Cuisine","boulder","CO","US","Voluntary: Firm Initiated","Telephone","Nation wide distribution and Canada.","F-1631-2013","Class II","Eco-Cuisine ''Chicken Style'' Quick Mix, SKU: RM10CKQM, Pack size 10 lb bag, Distributed by Eco-Cuisine and manufactured by Rocy Mountain Spice, and SKU: TV10CKQM, package size 10 lb bag, distributed by Eco-Cuisine and manufactured by TOVA.","Item number RM10CKQM lots E3112, G0312, G2412, H1612, J0912, B0813.",".","7.570 lbs","Eco-Cuisine is recalling certain spice/baking mixes due to potential contamination with salmonella as reported by their raw materials supplier.",5/16/2013,"05/16/2013",7/17/2013,"07/17/2013"
"Food",65204,"Ongoing","Eco-Cuisine","boulder","CO","US","Voluntary: Firm Initiated","Telephone","Nation wide distribution and Canada.","F-1629-2013","Class II","Eco-Cuisine Muffin Mix, SKU: CM25MUFF, Pack size 25 lb bag, Distributed by Eco-Cuisine and manufactured by Central Milling.","Item number CM25MUFF all lots.",".","2,500 lbs","Eco-Cuisine is recalling certain spice/baking mixes due to potential contamination with salmonella as reported by their raw materials supplier.",5/16/2013,"05/16/2013",7/17/2013,"07/17/2013"
"Food",65204,"Ongoing","Eco-Cuisine","boulder","CO","US","Voluntary: Firm Initiated","Telephone","Nation wide distribution and Canada.","F-1620-2013","Class II","Eco-Cuisine Betty Brownie Mix with Vanilla, Pack size 1.09 lb bag, 10 bags per case or 25 lbs bulk, Distributed by Eco-Cuisine and manufactured by All American Seasonings, Denver, CO.","Item number T3333 all lots.",".","1,010 lbs","Eco-Cuisine is recalling certain spice/baking mixes due to potential contamination with salmonella as reported by their raw materials supplier.",5/16/2013,"05/16/2013",7/17/2013,"07/17/2013"
"Food",65204,"Ongoing","Eco-Cuisine","boulder","CO","US","Voluntary: Firm Initiated","Telephone","Nation wide distribution and Canada.","F-1625-2013","Class II","Eco-Cuisine Lemon Muffin Mix, SKU: AA01MUFF-LM, Pack size 1 lb bag, 10 bags per case, Distributed by Eco-Cuisine and manufactured by All American Seasonings, Denver, CO.","Item number T3417 all lots.",".","1,005 lbs","Eco-Cuisine is recalling certain spice/baking mixes due to potential contamination with salmonella as reported by their raw materials supplier.",5/16/2013,"05/16/2013",7/17/2013,"07/17/2013"
"Food",65204,"Ongoing","Eco-Cuisine","boulder","CO","US","Voluntary: Firm Initiated","Telephone","Nation wide distribution and Canada.","F-1630-2013","Class II","Eco-Cuisine Basic Pancake Mix, SKU: TV25PANC, Pack size 25 lb bag, Distributed by Eco-Cuisine and manufactured by TOVA, Louisville, KY.","Item number TV25PANC, lot 001122331A",".","1,000 lbs","Eco-Cuisine is recalling certain spice/baking mixes due to potential contamination with salmonella as reported by their raw materials supplier.",5/16/2013,"05/16/2013",7/17/2013,"07/17/2013"
"Food",65204,"Ongoing","Eco-Cuisine","boulder","CO","US","Voluntary: Firm Initiated","Telephone","Nation wide distribution and Canada.","F-1627-2013","Class II","Eco-Cuisine Basic English Scone Mix, SKU: CM25SCONE, Pack size 25 lb bag, Distributed by Eco-Cuisine and manufactured by Central Milling.","Item number CM25SCONE all lots.",".","1,250 lbs","Eco-Cuisine is recalling certain spice/baking mixes due to potential contamination with salmonella as reported by their raw materials supplier.",5/16/2013,"05/16/2013",7/17/2013,"07/17/2013"
"Food",65204,"Ongoing","Eco-Cuisine","boulder","CO","US","Voluntary: Firm Initiated","Telephone","Nation wide distribution and Canada.","F-1624-2013","Class II","Eco-Cuisine Chocolate Chip Cookie Mix, SKU: AA01COOK-CC, Pack size 1 lb bag, 10 bags per case, Distributed by Eco-Cuisine and manufactured by All American Seasonings, Denver, CO.","Item number T3416 all lots.",".","1,005 lbs","Eco-Cuisine is recalling certain spice/baking mixes due to potential contamination with salmonella as reported by their raw materials supplier.",5/16/2013,"05/16/2013",7/17/2013,"07/17/2013"
"Devices",65205,"Ongoing","Surgical Instrument Service And Savings, Inc.","Redmond","OR","US","Voluntary: Firm Initiated","Letter","Nationwide Distribution.","Z-1644-2013","Class II","Harmonic ACE Ergonomically-Enhanced Curved Shear, Pistol Grip, Hand Controlled, (White) 5.0mm x 36cm Ref. ACE36E Lot 122295, 122308, 122762 Unclassified","122295, 122308, 122762. ",".","3","The seal which maintains a sterile barrier for reprocessed medical devices became compromised to the point where product may fall out of the pouch.",5/3/2013,"05/03/2013",7/10/2013,"07/10/2013"
"Devices",65205,"Ongoing","Surgical Instrument Service And Savings, Inc.","Redmond","OR","US","Voluntary: Firm Initiated","Letter","Nationwide Distribution.","Z-1636-2013","Class II","- IDEAL 30 Suture Grasper (Green) 30 Degree Ref. 251721 Lot 122511 - IDEAL 60 Suture Grasper (Pink) 60 Degree Ref. 251723 Lot 122631 Passer","122511, 122631. ",".","2","The seal which maintains a sterile barrier for reprocessed medical devices became compromised to the point where product may fall out of the pouch.",5/3/2013,"05/03/2013",7/10/2013,"07/10/2013"
"Devices",65205,"Ongoing","Surgical Instrument Service And Savings, Inc.","Redmond","OR","US","Voluntary: Firm Initiated","Letter","Nationwide Distribution.","Z-1639-2013","Class II","- Relieva Flex Sinus Guide Catheter (Green) Tip Shape: F-70 Ref. GC070RF Lot 122429 - Relieva Luma Sentry 20 Tip Angle, 0.035 Diameter 100cm Ref. SIS100B Lot 122429 Manual surgical instrument for general use ","122429",".","4","The seal which maintains a sterile barrier for reprocessed medical devices became compromised to the point where product may fall out of the pouch.",5/3/2013,"05/03/2013",7/10/2013,"07/10/2013"
"Devices",65205,"Ongoing","Surgical Instrument Service And Savings, Inc.","Redmond","OR","US","Voluntary: Firm Initiated","Letter","Nationwide Distribution.","Z-1638-2013","Class II","- Calf Garment Standard Ref. L501-M Lot 122549, 122985 - Calf Garment, DVT10 Standard Ref. DVT10 Lot 122570, 12546 - Calf Garment, DVT20 Large Ref. DVT20 Lot 122549, 122570 - SCD Express Compression Sleeve, Knee Length, (White) Large Ref. 9789 Lot 122574 - SCD Express Compression Sleeve, Knee Length, (White) Medium Ref. 9529 Lot 122547, 122574 - SCD Express Compression Sleeve, Thigh Length, (White) Medium Ref. 9530 Lot 122574 Compressible limb sleeve. - Thigh Garment DVT30 Medium Ref. DVT30 Lot 122549, 122985 - Thigh Garment DVT40 Large Ref. DVT40 Lot 122549, 122985 - Vaso-Force Intermittent DVT Calf Garment, Large, Calf Sizes up to 24'' 24'' Ref. MDS601L Lot 122982, 122986 - Vaso-Force Intermittent DVT Calf Garment, Medium, Calf Sizes up to 18'' 18'' Ref. MDS601M Lot 122986, 122984 - VENAFLOW Calf Cuff, w/Foam (White) 19'' Max. Calf Circumference Ref. 3010-PL Lot 122692, 122715 ","122692, 122982, 122986, 122984, 122549, 122985, 122570, 122546, 122547, 122574, 122715.",".","229","The seal which maintains a sterile barrier for reprocessed medical devices became compromised to the point where product may fall out of the pouch.",5/3/2013,"05/03/2013",7/10/2013,"07/10/2013"
"Devices",65205,"Ongoing","Surgical Instrument Service And Savings, Inc.","Redmond","OR","US","Voluntary: Firm Initiated","Letter","Nationwide Distribution.","Z-1629-2013","Class II","- Re-New II Endocut Scissor Tip, 16.51mm 5.0mm Ref. 3142 Lot 122295, 122308, 122455, 122875 Manual surgical instrument for general use. ","122295, 122308, 122455, 122875. ",".","10","The seal which maintains a sterile barrier for reprocessed medical devices became compromised to the point where product may fall out of the pouch.",5/3/2013,"05/03/2013",7/10/2013,"07/10/2013"
"Devices",65205,"Ongoing","Surgical Instrument Service And Savings, Inc.","Redmond","OR","US","Voluntary: Firm Initiated","Letter","Nationwide Distribution.","Z-1635-2013","Class II","- Cannulated Drill Bit for Mini TightRope Ref. AR-8911DC Lot 122511 - Drill Bit, Straight Shank 2.7mm x 12.7cm Ref. 2318-027-00 Lot 122322 - Drill Bit, w/Depth Mark, Quick Coupling (Red) 2.0mm x 140mm Ref. 323.062 Lot 122347 - Fast Cutting Drill Bit 2.0mm Ref. FDB 2.0 Lot 122289, 122322 - Midas Rex Metal Cutting Drill Bit 3.0mm x 18.3mm Ref. MC30 Lot 122347 Orthopedic manual surgical instrument","122347, 122289, 122322, 122511. ",".","10","The seal which maintains a sterile barrier for reprocessed medical devices became compromised to the point where product may fall out of the pouch.",5/3/2013,"05/03/2013",7/10/2013,"07/10/2013"
"Devices",65205,"Ongoing","Surgical Instrument Service And Savings, Inc.","Redmond","OR","US","Voluntary: Firm Initiated","Letter","Nationwide Distribution.","Z-1628-2013","Class II","90 Degree L-Hook Tip Arthroscopic Electrode, for use with 7205440 Switchpen, (Blue) 170mm. Ref. 7205441 Lot 122502 -Acromioplasty Electrode (Grey) 6.5'' x 165mm. Ref. C5012A Lot 122288 -CAPSure 30 ArthroWand, CW, 30 Degree Shaft Angle, (Grey) 3.0mm. Ref. AC 1830-01 Lot 122494 -Coblator II Evac 70 Xtra Plasma Wand, w/Integrated Saline Line & Integrated Cable. Ref. EIC 5872-01 Lot 122295, 122308, 122626, 122325, -Coblator II, ENT ReFlex Ultra 45 w/Integrated Cable, (Blue). Ref. EIC 4845-01 Lot 122651, 122419, 122671, 122633 Electrosurgical cutting and coagulation device and accessories. -CoVac 50, Suction ArthroWand, w/Integrated Cable, (White/Grey). Ref. ASC 2530-01 Lot 122483, 122745 -CoVac 70, ICW ArthroWand 70 angle 3.0mm. Ref. ASC 3730-01 Lot 122483, -Eliminator, Right Angle ArthroWand (Beige). Ref. A 1345-01 Lot 122446 -Eliminator, Right Angle ArthroWand, 90 Degree w/Integrated Cable, (Grey) 4.5mm. Ref. AC 1345-01 Lot 122494, 122446 -ENT Coblator II PROcise XP Wand, w/Integrated Cable, Suction & Saline, (Blue). Ref. EIC 8872-01 Lot 122651, 122762 -Ligament Chisel Probe,Curved w/Integrated Cable, (Grey/Green). Ref. 7209647 Lot 122512 -LightWave Suction Ablator, 90 Degree, Hand Control, Multi-Angle, (Blue/White) 4.5mm x 142mm. Ref. IA-2000-S Lot 122512 -Lo-Pro 90 Degree ArthroWand, w/Integrated Cable, (Grey) 3.6mm. Ref. AC1336-01 Lot 122654, 122325 -Meniscectomy Electrode, Standard Design (Grey) 165mm. Ref. C5010A Lot 122765 -MeniVac ArthroWand w/Suction, w/Integrated Cable, (Grey) 3.0mm. Ref. ASC 5500-01 Lot 122630, 122494 -Microblastor 30 Wand, 30 Degree, w/Integrated Cable, (Grey) 0.9mm Tip. Ref. AC 40500-01 Lot 122293 -Right Angle ArthroWand, 90 Degree, w/Integrated Cable, (Grey) 3.5mm. Ref. AC 1340-01 Lot 123044, 122673 -Saber 30 ArthroWand, 30 Degree, w/Integrated Cable, (Grey) 3.0mm. Ref. AC 4330-01 Lot 122630, 122494, 123044, 122283, 122765 -SAPHYRE II Bipolar Ablation Probe, w/suction, High Profile 50 Degree, (Pewter). Ref. 7210112 Lot 122734 -SERFAS ENERGY Hook Probe 3.5mm. Ref. 279-350-501 Lot 123","122029, 122295, 122486, 122577, 122734, 122654, 123266, 122651, 122427, 122630, 122494, 122595, 122419, 122446, 122308, 122671, 122455, 122593, 122626, 122483, 123044, 122283, 122466, 122673, 122745, 122589, 122306, 122356, 122435, 122502, 122639, 122293, 122663, 122325, 122512, 122765, 122765, 122762, 122409, 122318.",".","447 units","The seal which maintains a sterile barrier for reprocessed medical devices became compromised to the point where product may fall out of the pouch.",5/3/2013,"05/03/2013",7/10/2013,"07/10/2013"
"Devices",65205,"Ongoing","Surgical Instrument Service And Savings, Inc.","Redmond","OR","US","Voluntary: Firm Initiated","Letter","Nationwide Distribution.","Z-1641-2013","Class II","- CLEAR-TRAC COMPLETE, Threaded Cannula with Obturator, (Grey) 7.0mm x 72mm Ref. 72200905 Lot 122631, 122609 - CLEAR-TRAC Flexible Cannula System Threaded, w/Obturator, (Lime Green) 8.0mm x 72mm Ref. 72200425 Lot 122631 - CLEAR-TRAC Flexible Cannula, Threaded, w/Obturator, (Orange) 6.5mm x 72mm Ref. 72200427 Lot 122465 - Crystal Cannula w/Obturator (Orange) 5.75mm I.D. X 7cm Ref. AR-6460 Lot 122594, 122518 - Crystal Cannula, Partially Threaded, Distal End, w/Obturator, (Orange) 5.75mm I.D. x 7cm Ref. AR-6564 Lot 122493 - Dry-Doc Cannula System w/ Obturator (Translucent Green) 5.0mm x 85mm Ref. C7350 Lot 123263 - Dry-Doc Cannula w/ Obturator (Translucent Blue) 7.0mm x 85mm Ref. C7360 Lot 123263, 122594 - Instrument Cannula w/Obturator w/''No Squirt Cap'', (Purple) 7.0mm I.D. X 7cm Ref. AR-6550 Lot 122590 - Partially Threaded Cannula and Obturator, w/o ''No Squirt Cap'', (Purple) 7.0mm I.D. x 7cm Ref. AR-6567* Lot 123043, 122278 - PassPort Button Cannula'' (Blue) 8mm ID x 4cm Ref. AR-6592-08-40 Lot 122594 - Smooth Clear Cannula w/Obturator (Orange) 5.5mm x 75mm Ref. 214106 Lot 122465 - Threaded Clear Cannula w/Obturator (Orange) 5.5mm x 75mm Ref. 214108 Lot 122665 - Threaded Clear Cannula w/Obturator (Yellow) 8.5mm x 75mm Ref. 214120 Lot 122440, 122588 - Threaded Clear Cannula w/Obturator, (Purple) 7.0mm x 75mm Ref. 214116 Lot 122465 - Tibial Tunnel Cannula, Accomodates 9-12 mm Tunnel Diameters, (Blue) Ref. AR-1802D Lot 122594, 122279 - Twist-In Cannula w/Obturator w/''No Squirt Cap'', (Gold) 8.25mm I.D. X 7cm Ref. AR-6530 Lot 122590, 123190, 122665 - Twist-In Cannula w/Obturator, w/ ''No-Squirt'' Cap, (Green) 6.0mm I.D. x 7cm Ref. AR-6535 Lot 122590, 122665 - Twist-In Cannula w/Obturator, w/''No Squirt Cap'', (Purple) 7.0mm I.D. x 7cm Ref. AR-6570 Lot 123190 - Twist-In Cannula w/Obturator, w/o ''No Squirt Cap'', (Purple) 7.0mm I.D. x 7cm Ref. AR-6570* Lot 123043 - Twist-In Cannula w/Obturator, w/o No Squirt Cap, (Gold) 8.25mm I.D. x 7cm Ref. AR-653","122590, 123263, 123190, 122504, 122493, 122594, 123043, 122631, 122609, 122465, 122440, 122588, 122518, 122279, 122278, 122434, 122665.",".","73","The seal which maintains a sterile barrier for reprocessed medical devices became compromised to the point where product may fall out of the pouch.",5/3/2013,"05/03/2013",7/10/2013,"07/10/2013"
"Devices",65205,"Ongoing","Surgical Instrument Service And Savings, Inc.","Redmond","OR","US","Voluntary: Firm Initiated","Letter","Nationwide Distribution.","Z-1632-2013","Class II","Barron Radial Vacuum Trephine (1) Complete Trephine Set 9.0mm Dia. Ref. K20-2062 Lot 122336 Opthalmic ","122336 ",".","1","The seal which maintains a sterile barrier for reprocessed medical devices became compromised to the point where product may fall out of the pouch.",5/3/2013,"05/03/2013",7/10/2013,"07/10/2013"
"Devices",65205,"Ongoing","Surgical Instrument Service And Savings, Inc.","Redmond","OR","US","Voluntary: Firm Initiated","Letter","Nationwide Distribution.","Z-1643-2013","Class II","- ENDOPATH Resposable Bladeless Trocar, Non-Handled, w/Housing, 100mm, (Green) 10/11mm Ref. 511NA Lot 123215, 122647 - ENDOPATH Resposable Bladeless Trocar, Non-Handled, w/Housing, 100mm, (Orange) 5.0mm Ref. 35LNA Lot 123215, 122647 - ENDOPATH Resposable Trocar w/Dilating Tip Obturator & Housing, 100mm, (Orange) 5mm Ref. 35LDA Lot 122647 - ENDOPATH Resposable Trocar, Dilating Tip w/Housing, 100mm, (Purple) 10/12mm Ref. 512DA Lot 123215 - ENDOPATH Sleeve Housing (Orange) 5mm Ref. 355HR Lot 123215, 122647 Endoscope and accessories - ENDOPATH Trocar, Disposable Sleeve Housing, (Green) 10/11mm Ref. 511HR Lot 122647 - ENDOPATH Blunt Tip Obturator & Housing, w/Olive Plug, 100mm, (Purple) 10/12mm Ref. 512BA Lot 122647 - ENDOPATH Resposable Trocar w/ Dilating Tip Obturator & Housing, 100mm, (Green) 10/11mm Ref. 511DA Lot 122454, 122647 - ENDOPATH, Bladeless Trocar with Stability Sleeve, Non-handled 10/12mm Ref. 512NT Lot 123254 - ENDOPATH Xcel Bladeless Trocar, Handled, w/Stability Sleeve, (Teal) 11mm x 100mm Ref. 811LTH Lot 122300 - ENDOPATH Xcel Bladeless Trocar, w/Stability Sleeve 12mm x 150mm Ref. B12XT Lot 122300 - ENDOPATH Xcel Bladeless Trocar, w/Stability Sleeve 5.0mm x 150mm Ref. B5XT Lot 122429 - ENDOPATH Xcel Bladeless Trocar, w/Stability Sleeve, (Teal) 11mm x 100mm Ref. B11LT Lot 122454, 123254, 122429 - ENDOPATH Xcel Bladeless Trocar, w/Stability Sleeve, 100mm Length 5.0mm Ref. B5LT Lot 122347, 122454, 122592, 122490, 123254, 122429, 122300 - ENDOPATH Xcel Bladeless Trocar, w/Stability Sleeve, 75mm Length, (Teal) 5.0mm Ref. B5ST Lot 123254 - ENDOPATH Xcel Blunt Tip Trocar, w/Smooth Sleeve & Adjustable Plug, (Purple) 12mm x 100mm Ref. H12LP Lot 122338, 122372, 123254, 123215 - ENDOPATH Xcel Dilating Tip Trocar, w/Stability Sleeve, (Gold) 11mm x 100mm Ref. D11LT Lot 122454 - ENDOPATH Xcel Dilating Tip Trocar, w/Stability Sleeve, (Gold) 12mm x 100mm Ref. D12LT Lot 122454 - ENDOPATH Xcel Dilating Tip Trocar, w/Stability Sleeve, (Gold) 5.0mm x 100mm Ref","122338, 122347, 122454, 122592, 123372, 122490, 122490, 123254, 122609, 122429, 123215, 122647, 122300.",".","259","The seal which maintains a sterile barrier for reprocessed medical devices became compromised to the point where product may fall out of the pouch.",5/3/2013,"05/03/2013",7/10/2013,"07/10/2013"
"Devices",65205,"Ongoing","Surgical Instrument Service And Savings, Inc.","Redmond","OR","US","Voluntary: Firm Initiated","Letter","Nationwide Distribution.","Z-1630-2013","Class II","- Average Medium Blade 9mm x 25mm x 0.38mm Ref. 2296-3-111 Lot 122590, 122447 - Cannulated Drill Bit, Quick Coupling, For 3.5 & 4mm Cannulated Screws, 1.35mm Cannulation 2.7mm x 160mm Ref. 310.67 Lot 122289 - Hall MicroChoice, Oscillating Blade, Fine, Flat, Stainless Steel 5.5mm x 12.0mm x 0.4mm Ref. 5023-160 Lot 123353 - Hall MicroChoice, Oscillating Saw Blade, Fine, Flat, Stainless Steel 5.5mm x 18.5mm x 0.4mm Ref. 5023-162 Lot 123353 - Hall MicroChoice, Sagittal Saw Blade, Fine 4.5mm x 25.5mm x 0.4mm Ref. 5023-139 Lot 122454 - Hall MicroChoice, Sagittal Saw Blade, Stainless Steel 9.5mm x 25.5mm x 0.4mm Ref. 5023-138 Lot 122454, 123353 - Large Sagittal Saw Blade 25mm x 89.5mm x 0.89mm Ref. 2108-102 Lot 122490 - Micro Choice Oscillating Saw Blade 5.5mm x 18.5mm x 0.40mm Ref. KM-3000 Lot 122440 - Micro Oscillating and Sagittal Saw Blade 9.0mm x 25mm x 0.51mm Ref. 2296-33-521 Lot 122609, 122429 - Oscillating and Sagittal Saw Blade 9.0mm x 31mm x 0.51mm Ref. 2296-33-225 Lot 122347 - Oscillating Sagittal Blade 9mm x 31mm x .38mm Ref. 2296-3-525 Lot 123263 - Oscillating Saw Blade 9.0mm x 25.0mm x .38mm Ref. SP-511 Lot 122631 - Oscillating Saw Blade 9mm x 25mm x .38mm Ref. 2296-3-511 Lot 122447 - Reciprocating Saw Blade, Double Sided Fixed Point Travel: 3.56mm 70mm x 12.5mm x 0.64mm Ref. 227-96-275 Lot 122490 - Round Fast Cutting Stainless Steel Bur, 8 Flute 4.8mm Ref. 1608-6-139 Lot 122447 - Sagittal Saw Blade 4.5mm x 25.4mm Ref. KM-3102 Lot 122465 - Small Oscillating Blade 9.0mm x 31.0mm x .4mm Ref. 2296-3-125 Lot 122447 - Small Oscillating Saw Blade 5.5mm x 11.5mm x 0.38mm Ref. 2296-3-410 Lot 122429 - Small Oscillating Saw Blade 5.5mm x 18.0mm x 0.4mm Ref. 2296-3-212 Lot 122511 - Small Oscillating Saw Blade 5.5mm x 18mm x 0.38mm Ref. 2296-3-412 Lot 122447 - Small Oscillating Saw Blade 7mm x 18.5mm x 0.38mm Ref. 2296-3-114 Lot 122429, 122511 - Small Oscillating Saw Blade 9.0mm x 31mm x 0.4mm Ref. 2296-3-225 Lot 122590, 122447 - Sm","122590, 123263, 122347, 122454, 122490, 122631, 122289, 123353, 122609, 122465, 122440, 122429, 122447, 122647, 122511.",".","73","The seal which maintains a sterile barrier for reprocessed medical devices became compromised to the point where product may fall out of the pouch.",5/3/2013,"05/03/2013",7/10/2013,"07/10/2013"
"Devices",65205,"Ongoing","Surgical Instrument Service And Savings, Inc.","Redmond","OR","US","Voluntary: Firm Initiated","Letter","Nationwide Distribution.","Z-1637-2013","Class II","TPS Micro Reciprocating Small Tear Cross Cut Rasp 5.0mm x 11mm Ref. 5100-37-113 Lot 122518, 122447. Orthopedic manual surgical instrument","122518, 122447.",".","4","The seal which maintains a sterile barrier for reprocessed medical devices became compromised to the point where product may fall out of the pouch.",5/3/2013,"05/03/2013",7/10/2013,"07/10/2013"
"Devices",65205,"Ongoing","Surgical Instrument Service And Savings, Inc.","Redmond","OR","US","Voluntary: Firm Initiated","Letter","Nationwide Distribution.","Z-1633-2013","Class II","Abrader Bur, Round (Aqua) 4.0mm Ref. 7205324 Lot 123270 - AcromioBlaster Burr (Brick Red) 5.5mm Ref. 7205669 Lot 122590, 122454, 122465, 122434, 122665 - AcromioBlaster Burr (Sage Green) 4.0mm Ref. 7205668 Lot 122590, 123270 - Acromionizer Bur, Barrel, (Mauve) 4.0mm Ref. 7205326 Lot 122609 - BoneCutter Blade, Full Radius, Series 3000 (Orange/Black) 5.5mm Ref. 7206010 Lot 122609 - CoolCut Bone Cutter (Blue/Orange) 3.8mm Ref. AR-8380BC Lot 122631 arthoscope - CoolCut Bone Cutter (Blue/Orange) 4.0mm Ref. AR-8400BC Lot 122631 - CoolCut Bone Cutter (Blue/Orange) 5.5mm Ref. AR-8550BC Lot 122631 - CoolCut Dissector (Blue/Blue) 3.5mm Ref. AR-8350DS Lot 123190 - CoolCut Dissector (Blue/Blue) 4.0mm Ref. AR-8400DS Lot 123190, 122493, 122631 - CoolCut Dissector (Blue/Blue) 5.0mm Ref. AR-8500DS Lot 122493 - CoolCut Dissector Small Joint (Blue/Blue) 3.0mm Ref. AR-7300DS Lot 123190, 122493, 122631, - CoolCut Excalibur (Blue/Beige) 3.8mm Ref. AR-8380EX Lot 122631 - CoolCut Excalibur (Blue/Beige) 4.0mm Ref. AR-8400EX Lot 122631 - CoolCut Oval Burr (12 Flutes) (Blue/White) 5.5mm Ref. AR-8550OBT Lot 122631 - CoolCut Oval Burr (8 Flute) (Blue/White) 4.0mm Ref. AR-8400OBE Lot 122493, 122631, 122279 - CoolCut Oval Burr (8 Flute) (Blue/White) 5.0mm Ref. AR-8500OBE Lot 122493 - CoolCut Round Burr (8 Flute) (Blue/Red) 5.0mm Ref. AR-8500RBE Lot 123190 - CoolCut Sabre (Blue/Green) 3.8mm Ref. AR-8380SR Lot 122493 - DYONICS ELITE Achromobacter (Sage Green) 4.0mm Ref. 72200730 Lot 122665 - Elite* AcromioBlaster Burr (Brick Red/Yellow) 5.5mm Ref. 72200731 Lot 122665 - Formula Aggressive Plus Cutter (Beige/Blue) 5.5mm Ref. 375-564-000 Lot 122309 - Formula Aggressive Plus Cutter (Dk. Blue/Lt. Blue) 5.0mm Ref. 375-554-000 Lot 122490 - Formula Aggressive Plus Cutter (Yellow/Blue) 3.5mm Ref. 375-534-000 Lot 122518, 122309 - Formula Aggressive Plus Cutter Large Hub, (Red/Blue) 4.0mm Ref. 375-544-000 Lot 122594, 122588, 122518, 122278 - Formula Barrel Bur, 12-Flute (Beige/Beige) 5.5mm Ref. 375-951-012 Lot 122278 - Formula Barrel Bur, 12-Flute (Blu","122590, 122338, 123263, 122347, 123190, 122493, 122594, 122592, 122482, 122490, 122631, 122289, 123353, 122609, 122465, 122440, 123270, 122588, 122518, 122309, 122279, 122278, 122434, 122665, 122511.",".","907","The seal which maintains a sterile barrier for reprocessed medical devices became compromised to the point where product may fall out of the pouch.",5/3/2013,"05/03/2013",7/10/2013,"07/10/2013"
"Devices",65205,"Ongoing","Surgical Instrument Service And Savings, Inc.","Redmond","OR","US","Voluntary: Firm Initiated","Letter","Nationwide Distribution.","Z-1634-2013","Class II","Large Tear Cross Cut Rasp 14mm x 7mm Ref. 5100-37-114 Lot 122347 Manual surgical instrument for general use ","122347 ",".","2","The seal which maintains a sterile barrier for reprocessed medical devices became compromised to the point where product may fall out of the pouch.",5/3/2013,"05/03/2013",7/10/2013,"07/10/2013"
"Devices",65205,"Ongoing","Surgical Instrument Service And Savings, Inc.","Redmond","OR","US","Voluntary: Firm Initiated","Letter","Nationwide Distribution.","Z-1627-2013","Class II","-Scorpion Needle, For Use With Scorpion Suture Passer, (Blue). Ref. AR-13990N Lot 123263 -SureFire Scorpion Needle (purple). Ref. AR-13991N Lot 123263 and 122279 -Suture Passing Wire. Ref. AR-1255-18 Lot 123190 Manual surgical instrument for general use.","123263, 122279, 123190.",".","6 units","The seal which maintains a sterile barrier for reprocessed medical devices became compromised to the point where product may fall out of the pouch.",5/3/2013,"05/03/2013",7/10/2013,"07/10/2013"
"Devices",65205,"Ongoing","Surgical Instrument Service And Savings, Inc.","Redmond","OR","US","Voluntary: Firm Initiated","Letter","Nationwide Distribution.","Z-1631-2013","Class II","- Acorn Bur, Long, For Use With TPS Universal Drill, Long ''AM'' Attachment Head: 7.5mm Dia. x 9.5mm Length Ref. 5130-30-75 Lot 122665 - Cannulated Drill Bit, for 3.0mm Cannulated Screws, 1.2mm Cannulation, Quick Coupling 2.0mm x 150mm Ref. 310.221 Lot 122289 - Drill Bit, For Modular Hand System, Quick Coupling 2.8mm x 165mm Ref. 310.288 Lot 122322 - Drill Bit, Quick Coupling (Gold) 2.5mm Ref. DB-2.5 Lot 122289, 122322 - Egg Micro Bur, 10 Flute, Stainless Steel 4.0mm Ref. 1608-2-35 Lot 122429, 122347 - Hall Micro Bur, Oval, Long, 8-Flute, Carbide 4.0mm x 8.0mm Ref. 5092-136 Lot 123353 - Micro Bur, Round, Stainless Steel 3.2mm Ref. 1608-2-11 Lot 122447, 122347 - Oval Bur, Fast Cutting, 8-Flutes, Carbide, 44.5mm Total Length, 18.6mm Exposure 4.0mm x 7.9mm Ref. 227-10-62 Lot 122411 - Oval Bur, Solid, 8-Flute, Medium, Head Length: 7.7mm, Carbide 4.0mm x 48mm Ref. 5300-10-901 Lot 122647 - Oval Cutting Carbide Bur, Medium, (8-Flute) 4.0mm Ref. 5091-136 Lot 123353, 122454 - Round Bur, Medium, Solid 8-Flute, Carbide 4.0mm x 48.3mm Ref. 5300-10-511 Lot 122665 - Round Bur, Micro, 8-Flute, Exposure: 28.2mm Stainless Steel 2.4mm x 54mm Ref. 1608-2-9 Lot 122447 - Twist Drill, Quick Coupling 110mm 2.5mm Ref. 310.25 Lot 122289, 122322 - Wire Pass Drill Bit 1.5mm Ref. 1608-2-59 Lot 122511 Surgical instrument motors and accessories/attachments ","122347, 122454, 122411, 122289, 123353, 122429, 122322, 122447, 122665, 122647, 122511.",".","30","The seal which maintains a sterile barrier for reprocessed medical devices became compromised to the point where product may fall out of the pouch.",5/3/2013,"05/03/2013",7/10/2013,"07/10/2013"
"Devices",65205,"Ongoing","Surgical Instrument Service And Savings, Inc.","Redmond","OR","US","Voluntary: Firm Initiated","Letter","Nationwide Distribution.","Z-1626-2013","Class II","GII QuickAnchor Plus, ETHIBOND Polyester Suture, 36'', double-Armed w/CP 2 Needles 2. Ref. 212034 Lot 123266 General and Plastic Surgery","123266",".","2","The seal which maintains a sterile barrier for reprocessed medical devices became compromised to the point where product may fall out of the pouch.",5/3/2013,"05/03/2013",7/10/2013,"07/10/2013"
"Devices",65205,"Ongoing","Surgical Instrument Service And Savings, Inc.","Redmond","OR","US","Voluntary: Firm Initiated","Letter","Nationwide Distribution.","Z-1642-2013","Class II","- Turbosonics Mini-Flared ABS Tip, 45 Degree OZil 12 Degree, (Purplish/ Pink) 0.9mm Ref. 8065751177 Lot 123215 - TurboSonics Mini-Flared ABS Tip, 20 Degree Tip Angle, 45 Kelman, (Purplish Pink/Silver) 0.9mm Ref. 8065750853 Lot 122590, 123372 - TurboSonics Tapered ABS MicroTip'' 30 Kelman, (Purple/Silver) 0.9mm Ref. 8065750263 Lot 122309 Series 20000'' Legacy TurboSonics Flared ABS MicroTip, 30 Degree, Kelman, (Pink) 0.9mm Ref. 8065740839 Lot. 122309 Phacofragmentation system. ","122590, 123372, 123215, 122309. ",".","90","The seal which maintains a sterile barrier for reprocessed medical devices became compromised to the point where product may fall out of the pouch.",5/3/2013,"05/03/2013",7/10/2013,"07/10/2013"
"Devices",65205,"Ongoing","Surgical Instrument Service And Savings, Inc.","Redmond","OR","US","Voluntary: Firm Initiated","Letter","Nationwide Distribution.","Z-1625-2013","Class II","-ENDOPATH ETS-Flex Articulating Endoscopic Linear Cutter, (Blue) w/o Staples 35mm. REF ATB35 Lot 122300. -Ligaclip MCA Multiple Clip Applier, 20 Small Clips Small. REF MCS20 Lot 122300. - Ethicon Pistol Grip, Fixed Head Skin Stapler, Multi-Directional Release, (Grey) 35W. REF PXW35 Lot 122309 and Lot 123263. -Proximate Linear Cutter, w/o Staples 75mm. REF TLC75 Lot 122490 -Ethicon Proximate Plus MD, Skin Stapler Regular. REF PMR35 Lot 122753. -Proximate Plus, Rotating Head, Skin Stapler (White) Wide. REF PRW35 Lot 122406. - Ethicon PROXIMATE PLUS, Skin Stapler, Pistol Grip, Fixed Head, Multi-Directional Release, (Grey) Regular. REF PXR35 Lot 122675 and Lot 123263. -TX Reloadable Linear Stapler 3.5mm Leg, w/o Staples 60mm. Ref. TX60B Lot 122490 Manual surgical instrument for general use ","122300, 123263, 122490, 122753, 122406, 122675, 122309",".","13","The seal which maintains a sterile barrier for reprocessed medical devices became compromised to the point where product may fall out of the pouch.",5/3/2013,"05/03/2013",7/10/2013,"07/10/2013"
"Devices",65205,"Ongoing","Surgical Instrument Service And Savings, Inc.","Redmond","OR","US","Voluntary: Firm Initiated","Letter","Nationwide Distribution.","Z-1623-2013","Class II","-Instratek Carpal Tunnel Release Blades, (1) Triangle Blade, (1) Hook Blade. REF R2056 - LOT 122279 -Instratek Carpal Tunnel Release Hook Blade. REF 2055 Lot 122669 -Linvatec CTS Relief Kit. REF 9971, lot 122504 -Biomet Indiana Tome Blade for Carpal Tunnel Release (White). REF 200060. Lot 122504 and Lot 123190. -KMI SafeGuard Knife, For SafeGuard Mini Carpal Tunnel Release System, (White). REF 08-0003. Lot # 122609 Surgical Knife","122279; 122493; 122504; 122609; 122669; 123190 ",".","56 units","The seal which maintains a sterile barrier for reprocessed medical devices became compromised to the point where product may fall out of the pouch.",5/3/2013,"05/03/2013",7/10/2013,"07/10/2013"
"Devices",65205,"Ongoing","Surgical Instrument Service And Savings, Inc.","Redmond","OR","US","Voluntary: Firm Initiated","Letter","Nationwide Distribution.","Z-1640-2013","Class II","- ACCU-PASS Suture Shuttle, 70 Degree, Upbend, (Orange) Ref. 72200419 Lot 122504 - Carpal Tunnel Release Blade Assembly, (White) Ref. 81010 Lot 123263, 122406, 122482, 123043, 122518, 122511 - ENDO-SCRUB 2, (1) Sheath, 0 Degree, For K. Storz, Medtronic Sharpsite AC, (Green) 4.0mm Ref. 19-12000 Lot 122289 - Spectrum II Disposable Suture Hook 45 degree, Right (RED) Ref. C6380 Lot 122592 Orthopedic manual surgical instrument. ","123263, 122504, 122406, 122592, 122482, 123043, 122289, 122518, 122511. ",".","34","The seal which maintains a sterile barrier for reprocessed medical devices became compromised to the point where product may fall out of the pouch.",5/3/2013,"05/03/2013",7/10/2013,"07/10/2013"
"Devices",65205,"Ongoing","Surgical Instrument Service And Savings, Inc.","Redmond","OR","US","Voluntary: Firm Initiated","Letter","Nationwide Distribution.","Z-1624-2013","Class II","- ConMed Linvatec Spectrum II Suture Hook Crescent, Medium (Teal) 4.0 x 20.0mm. REF C6386 Lot 122592. - Arthrex SutureLasso SD, 25 Degree Tight Curve Left, Wire Loop, (Green) 1.8mm. REF AR-4068-25TL Lot 122518 and Lot 123190. -- Arthrex SutureLasso SD, 25 Degree Tight Curve Right, w/Nitinol Wire Loop, (Lt. Green) 1.8mm. REF AR-4068-25TR Lot 122518 and Lot 123190. - Arthrex SutureLasso SD, 90 Degrees (Black) 1.8mm. REF AR-4068-90 Lot 122504. - Arthrex SutureLasso, 45 Degree, Perforating Needle Cannula, w/Suture Loop, (Lt. Grey). REF AR-4065S Lot 122590. -SutureLasso, w/Wire Loop, 90 Degree, (Blue) REF AR-4065-90W Lot 123263. Manual surgical instrument for general use","122504; 122518; 122504; 122590; 122592; 123190; 123263.",".","15","The seal which maintains a sterile barrier for reprocessed medical devices became compromised to the point where product may fall out of the pouch.",5/3/2013,"05/03/2013",7/10/2013,"07/10/2013"
"Biologics",65206,"Terminated","Community Blood Centers of Florida, Inc.","Miami","FL","US","Voluntary: Firm Initiated","Telephone","Florida; New York","B-2101-13","Class II","Red Blood Cells Leukocytes Reduced Irradiated","2629093; ",".","1","Blood products, collected from a donor in whom donor suitability was not adequately determined, were distributed.",5/7/2013,"05/07/2013",8/28/2013,"08/28/2013"
"Biologics",65206,"Terminated","Community Blood Centers of Florida, Inc.","Miami","FL","US","Voluntary: Firm Initiated","Telephone","Florida; New York","B-2102-13","Class II","Platelets Pooled Leukocytes Reduced","2928447; ",".","1","Blood products, collected from a donor in whom donor suitability was not adequately determined, were distributed.",5/7/2013,"05/07/2013",8/28/2013,"08/28/2013"
"Devices",65207,"Ongoing","Ortho-Clinical Diagnostics","Rochester","NY","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution - USA Nationwide including the states of AL, AR, AZ, CA, CO, CT, FL, GA, IA, ID, IL, IN, KS, KY, LA, MA, MD, MI, MN, MO, MS, MT, NC, ND, NE, NJ, NY, OH, OK, OR, PA, SC, SD, TN, TX, VA, WA, WI & WV, and countries of: Australia, Brazil, Canada, Chile, China, Colombia, India, Japan, Mexico, PR, Panama, Singapore, Venezuela, England, France, Germany, Italy, Spain","Z-1649-2013","Class II","VITROS 5600 Integrated System (product code 6802413) Product Usage: For use in the in vitro quantitative, semi-quantitative, and qualitative measurement of a variety of analytes of clinical interest, using VITROS Chemistry Products Slides, VITROS Chemistry Products MicroTip Reagents and VITROS Immunodiagnostic Products Reagents.","Serial numbers: J56000110, J56000118 and J56001095 through J56001507",".","Total 381 units ( 227 units domestically & 154 units internationally)","There is evidence that an electrical short within the systems connector has caused an accumulation of heat which has radiated back through the wiring harness causing the wires and connectors to melt.",5/6/2013,"05/06/2013",7/10/2013,"07/10/2013"
"Devices",65207,"Ongoing","Ortho-Clinical Diagnostics","Rochester","NY","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution - USA Nationwide including the states of AL, AR, AZ, CA, CO, CT, FL, GA, IA, ID, IL, IN, KS, KY, LA, MA, MD, MI, MN, MO, MS, MT, NC, ND, NE, NJ, NY, OH, OK, OR, PA, SC, SD, TN, TX, VA, WA, WI & WV, and countries of: Australia, Brazil, Canada, Chile, China, Colombia, India, Japan, Mexico, PR, Panama, Singapore, Venezuela, England, France, Germany, Italy, Spain","Z-1647-2013","Class II","1) VITROS 5,1 FS Chemistry System (product code 6801375) and 2) VITROS 5,1 FS Chemistry System Refurbished (product code 6801890) Product Usage: For use in the in vitro quantitative, semi-quantitative, and qualitative measurement of a variety of analytes of clinical interest, using VITROS Chemistry Products Slides, VITROS Chemistry Products MicroTip Reagents and VITROS Immunodiagnostic Products Reagents.","Serial numbers: 1) J34000240, J34000714, J34001562 and J34002163 through J34002245, 2) 34000193, 34000420, 34000478, 34000495, 34000497, 34000529, 34000596, 34000799, 34000805, 34000947, 34001243, 34001422, 34001504, 34001569, 34001589, 34001610, 34001633",".","Total 101 units (84 units for # 6801375- 26 units domestic & 58 units foreign) and (17 units for # 6801890-15 units domestic, 2 units foreign)","There is evidence that an electrical short within the systems connector has caused an accumulation of heat which has radiated back through the wiring harness causing the wires and connectors to melt.",5/6/2013,"05/06/2013",7/10/2013,"07/10/2013"
"Devices",65207,"Ongoing","Ortho-Clinical Diagnostics","Rochester","NY","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution - USA Nationwide including the states of AL, AR, AZ, CA, CO, CT, FL, GA, IA, ID, IL, IN, KS, KY, LA, MA, MD, MI, MN, MO, MS, MT, NC, ND, NE, NJ, NY, OH, OK, OR, PA, SC, SD, TN, TX, VA, WA, WI & WV, and countries of: Australia, Brazil, Canada, Chile, China, Colombia, India, Japan, Mexico, PR, Panama, Singapore, Venezuela, England, France, Germany, Italy, Spain","Z-1650-2013","Class II","VITROS 3600 Immunodiagnostic System (product code 6802783) Product Usage: For use in the in vitro quantitative, semi-quantitative, and qualitative measurement of a variety of analytes of clinical interest, using VITROS Immunodiagnostic Products Reagents","Serial numbers: J36000111 and J36000520 through J36000617",".","Total 98 units (30 units domestically & 68 units internationally)","There is evidence that an electrical short within the systems connector has caused an accumulation of heat which has radiated back through the wiring harness causing the wires and connectors to melt.",5/6/2013,"05/06/2013",7/10/2013,"07/10/2013"
"Devices",65207,"Ongoing","Ortho-Clinical Diagnostics","Rochester","NY","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution - USA Nationwide including the states of AL, AR, AZ, CA, CO, CT, FL, GA, IA, ID, IL, IN, KS, KY, LA, MA, MD, MI, MN, MO, MS, MT, NC, ND, NE, NJ, NY, OH, OK, OR, PA, SC, SD, TN, TX, VA, WA, WI & WV, and countries of: Australia, Brazil, Canada, Chile, China, Colombia, India, Japan, Mexico, PR, Panama, Singapore, Venezuela, England, France, Germany, Italy, Spain","Z-1648-2013","Class II","VITROS 4600 Chemistry System (VITROS 5,1 FS System family member)(product code 6802445) Product Usage: For use in the in vitro quantitative measurement of a variety of analytes of clinical interest, using both VITROS Chemistry Products Slides (colorimetric endpoint, rate, ion-selective electrode, and immunorate methods) and VITROS Chemistry Products MicroTip liquid reagents (spectrophotometric and spectrophotometric immunoassay methods.)","Serial numbers: J46000021, J46000110 through J46000177",".","Total 69 units (28 units domestically and 41 units internationally)","There is evidence that an electrical short within the systems connector has caused an accumulation of heat which has radiated back through the wiring harness causing the wires and connectors to melt.",5/6/2013,"05/06/2013",7/10/2013,"07/10/2013"
"Devices",65207,"Ongoing","Ortho-Clinical Diagnostics","Rochester","NY","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution - USA Nationwide including the states of AL, AR, AZ, CA, CO, CT, FL, GA, IA, ID, IL, IN, KS, KY, LA, MA, MD, MI, MN, MO, MS, MT, NC, ND, NE, NJ, NY, OH, OK, OR, PA, SC, SD, TN, TX, VA, WA, WI & WV, and countries of: Australia, Brazil, Canada, Chile, China, Colombia, India, Japan, Mexico, PR, Panama, Singapore, Venezuela, England, France, Germany, Italy, Spain","Z-1651-2013","Class II","ORTHO Assay Software (OAS) Server, Catalog # 6842840 Usage: The ORTHO Summit System (OSS) is a modular, integrated system for use with licensed blood screening tests. Consisting of networked processors and instruments linked together via a local area network, assay-specific pipetting protocols and ORTHO Assay Software (OAS), OSS automates many of the processing functions and data management requirements associated with ELISA (enzyme-linked immunosorbent assay) microplate testing. ","Serial numbers: 0811F06216 through 0811F06225 and 0911F06240 through 0911F06245 and 1011F06317 through 1011F06331",".","31 units","There is evidence that an electrical short within the systems connector has caused an accumulation of heat which has radiated back through the wiring harness causing the wires and connectors to melt.",5/6/2013,"05/06/2013",7/10/2013,"07/10/2013"
"Food",65208,"Ongoing","Bao Gong Da Inc","Pico Rivera","CA","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","US States: CA, TX, NV, NY.","F-1543-2013","Class III","Ginseng. American Ginseng, 4 oz. and 8 oz. retail packages and bulk ginseng in 20, 30, or 40 lbs. in a clear plastic bag. Bulk products are not labeled. ","No codes or lot numbers used. Production start and end date: 2/1/2013 - 3/31/2013",,"2,422 lbs","The firm initiated this recall of ''American Ginseng'' because FDA lab analysis found pesticide residues.",5/10/2013,"05/10/2013",6/26/2013,"06/26/2013"
"Devices",65209,"Ongoing","Biomet, Inc.","Warsaw","IN","US","Voluntary: Firm Initiated","Letter","Distributed in New York.","Z-1465-2013","Class II","Active Articulation E1. Intended for use with either primary or revision hip arthroplasty. ","Part numbers: EP-200162, EP-200162, EP-200164, and EP-200166 with Lot numbers: 027050, 101470, 115950, 101480, 247990, 948810, 967270, 027070, 287820, 729870, and 860880.",".","8 units","Biomet is recalling Active Articulation E1 Hip Bearing implants. Biomet has initiated this action following an investigation which identified that outer label indicates two conflicting O.D. sizes while the inner labels indicate an incorrect O.D. size. The implant itself is etched with the correct O.D. size.",4/26/2013,"04/26/2013",6/12/2013,"06/12/2013"
"Devices",65210,"Ongoing","Biomet, Inc.","Warsaw","IN","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution - USA Nationwide: CA, TX, NY, PA, NJ, FL, OH, MI, CO, SD, IN, MT, GA, and WI. and the countries of Netherlands, Costa Rica, Japan, and San Juan.","Z-1547-2013","Class II","Biomet Trauma Phoenix Retrograde Femoral Connecting Bolt Trauma Fixation Systems. Product Usage: The Phoenix Retrograde Femoral Nail is indicated for alignment, stabilization, and fixation of fractures caused by trauma or disease and the fixation of femurs that have been surgically prepared (osteotomy) for correction of deformity. ","Catalog number: 14-442021 and lot number:757910",,"75","Biomet Trauma (''Biomet'') has initiated a recall of Retrograde Femoral Connecting Bolt, which involves Part Number 14-442021. The connecting bolt has an undersized diameter specification that may cause an interference fit with the 4mm hex driver (Part Number: 41024) near the edge of the tolerance. If the 4mm hex driver becomes stuck in the connecting bolt it cannot be taken apart and a delay in surgery of greater than 30 minutes may occur.",4/29/2013,"04/29/2013",6/26/2013,"06/26/2013"
"Food",65211,"Ongoing","Arthur Schuman Midwest LLC","Elgin","IL","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Nationwide (MA and VA)","F-1465-2013","Class I","GRATED 2/25 GRANA PADANO; Lot Code: 313701A01; Pack Size: 2/25#; Net Pounds: 50; PACK DATE: 05/18/13; ITEM#DGP03; arthur schuman inc, 40 new dutch lane fairfield nj 07004 U.S.A.; 937-227-0030 www.arthurschuman.com; ","Product Code: ARG07146JP; Lot No.: 311501A01",".","2,500 lbs.","Grated Grana Padano Hard Italian Cheese was tested and found to be positive for Listeria monocytogenes.",5/15/2013,"05/15/2013",6/5/2013,"06/05/2013"
"Devices",65212,"Ongoing","Biomet, Inc.","Warsaw","IN","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution-USA (nationwide) including the states of UT, TX, AL, KY, and WI, and the countries of Australia, The Netherlands, Korea, and Canada.","Z-1548-2013","Class II","Superior Approach Resection Guide Assembly. Indicated for primary, fracture, or revision total shoulder replacement for the relief of pain. ","Catalog number: 010001814 and lot numbers: 318520 and 644720.",,"17","Biomet has initiated this action following an investigation which identified that the slot on the resection guide is offset in the wrong direction. When the slot on the resection guide is offset in the wrong direction, the Steinman pin that is intended to hold the guide into place may not come into contact with the bone.",5/15/2013,"05/15/2013",6/26/2013,"06/26/2013"
"Drugs",65213,"Ongoing","Fresenius Kabi USA, LLC","Lake Zurich","IL","US","Voluntary: Firm Initiated","Letter","Nationwide and Puerto Rico","D-688-2013","Class III","Folic Acid Injection, USP, 5 mg/mL, For IM, IV or SC Use, 10 mL, Multiple Dose Vial, Rx only, APP Pharmaceuticals, LLC, Schaumburg, IL 60173, NDC 63323-184-11","Lot #: 6103883, Exp 10/2013",".","80,480 vials","Failed Impurities/Degradation Specification",5/21/2013,"05/21/2013",7/17/2013,"07/17/2013"
"Devices",65215,"Ongoing","Baxa Corporation","Englewood","CO","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution-USA (nationwide) including Puerto Rico, and the countries of Canada, Latin America, Europe/Middle East/Africa, and Taiwan.","Z-1752-2013","Class II","ExactaMix 1200 and 2400 Compounders. Used as an automated pumping system that compounds multiple sterile ingredients into a finished solution. ","ExactaMix 1200 serial numbers 45004-45481 (sequentially), and ExactaMix 2400 serial numbers 40005-40335.",".","753 units","Baxter Healthcare is recalling certain ExactaMix automated compounding devices due to the complementary metal oxide semi-conductor battery failure resulting in resetting the internal clock of the device to midnight December 31, 2010.",6/4/2013,"06/04/2013",7/24/2013,"07/24/2013"
"Devices",65216,"Ongoing","Intuitive Surgical, Inc.","Sunnyvale","CA","US","Voluntary: Firm Initiated","E-Mail","Worldwide distribution - USA (nationwide) Foreign Distribution to Argentina, Austria, Australia, Belgium, Brazil, Bulgaria, Canada, China, Chile, Czech Republic, Denmark, Finland, France, Germany, Cyprus- Greece, Egypt, Guadeloupe, Israel, Ireland, India, Indonesia, Italy, Japan, Kuwait, Lebanon, Malaysia, Mexico, Monaco, Netherlands, New Zealand, Norway, Pakistan, Philippines, Portugal, Poland, Qatar, Russia, Romania, Slovenia, South Korea, Spain, Sweden, Switzerland, Thailand, Taiwan, Turkey, United Kingdom, Saudi Arabia, Singapore, South Korea, and Venezuela.","Z-1442-2013","Class II","8 mm Monopolar Curved Scissors (a.k.a. Hot Shears) Manufactured and Distributed by: Intuitive Surgical Sunny vale, CA The EndoWrist Monopolar Curved Scissors Instrument is a multiple-use endoscopic instrument utilizing a single use, tip cover accessory, to be used in conjunction with the Intuitive Surgical Endoscopic Instrument Control System. ","Model Numbers 420179-09 and -10 and 400179-09 and -10.",".","~132,441 instruments","Intuitive Surgical has identified a potential for some units of the Monopolar curved Scissors version 09 and 10 instruments to develop very small cracks near the distal end. This may create a pathway for electrosurgical energy to leak to tissue and potentially cause thermal injury.",5/8/2013,"05/08/2013",6/12/2013,"06/12/2013"
"Devices",65217,"Ongoing","Applied Medical Resources Corp","Rancho Santa Margarita","CA","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution: USA Nationwide and countries of: Argentina, Austria, Australia, Bahrain, Belgium, Canada, Chile, Columbia, Denmark, Ecuador, Finland, France, Germany, Greece, India, Ireland, Israel, Italy, Jordan, Kuwait, Malaysia, Lebanon, Lybia, Mexico, Netherlands, New Zealand, Pakistan, Peru, Poland, Portugal, Qatar, Saudi Arabia, Serbia, Singapore, Spain, South Africa, Switzerland, Taiwan-Province of China,Turkey, United Arabs Emirates United Kingdom, Uruguay, and Venezula-Bolivarian Republic.","Z-1521-2013","Class II","Applied Medicals Epix and Direct Drive Laparoscopic Graspers, Model Numbers C4130 and C4140. Used for grasping and manipulating tissue during general or laparoscopic surgery. ","Model Numbers C4130 and C4140. MODEL NUMBERS C4130- 5mm x 35cm Epix/Direct Drive Laparoscopic Grasper LOT NUMBERS 1145332, 1145943, 1145944, 1145945, 1145992, 1145993, 1145994, 1146371, 1147900, 1147901, 1147955, 1148172, 1148173, 1148174, 1148180, 1148181, 1148184, 1148190, 1148191, 1148192, 1148194, 1148201, 1148203, 1148677, 1148765, 1148766, 1148767, 1148835, 1149040, 1149041, 1149690, 1149757, 1150168, 1150169, 1150170, 1150490, 1150634, 1151246, 1151247, 1151248, 1152274, 1152728, 1153332, 1154394, 1154637, 1155135, 1155473, 1155948, 1156004, 1156010, 1156011, 1156012, 1156270, 1156360, 1156452, 1156577, 1156857, 1157218, 1157679, 1157950, 1157951, 1157952, 1157953, 1157954, 1158052, 1158131, 1158216, 1158217, 1158425, 1159491, 1160167, 1161136, 1161137, 1161398, 1161638, 1162112, 1162503, 1162504, 1162588, 1163399, 1163558, 1163559, 1163575, 1164580, 1164581, 1164582, 1164583, 1168124, 1168637, 1168638, 1169117, 1171168, 1171631, 1172170, 1172668, 1173153, 1174995, 1174996, 1176616, 1177407, 1177408, 1178109, 1180295, 1181554, 1182940, 1183774, 1184416, 1184959, 1187241, 1188110, 1188745, 1189773, 1191368, 1191809. C4140- 5mm x 45cm Epix/Direct Drive Laparoscopic Grasper 1145559, 1147851, 1147852, 1147960, 1148210, 1148211, 1149038, 1149039, 1149689, 1149936, 1150488, 1150489, 1151249, 1152594, 1153330, 1155645, 1157217, 1157949, 1158644, 1160033, 1160170, 1162111, 1167871, 1169855, 1171497, 1172009, 1173587, 1174121, 1177578, 1179347, 1180753, 1181346, 1182924, 1183769, 1184961, 1188111, 1189182 Various Kits Containing Either C4130 or C4140 1148079, 1148139, 1148145, 1148250, 1148514, 1148770, 1148780, 1149100, 1149605, 1150455, 1151831, 1153074, 1153702, 1154931, 1154997, 1155332, 1156581, 1156812, 1157090, 1158535, 1160152, 1160227, 1160388, 1161766, 1162189, 1162343, 1163348, 1163881, 1164590, 1164796, 1164831, 1165443, 1166520, 1168227, 1169190, 1169456, 1169620, 1169772, 1170151, 1170378, 1171280, 117",".","127,305 units","Applied Medical is conducting a voluntary recall on specific lot numbers of its Epix and Direct Drive Laparoscopic Graspers. When the ratchet trigger is activated, if a great enough force is applied, there is a potential for the trigger to fracture and the jaws to remain in the closed position. The likelihood of this situation to occur and result in permanent patient injury is highly unlikely; however, out of an abundance of caution for patient safety and a commitment to provide only the highest quality products, Applied has decided to recall all potentially affected units.",5/1/2013,"05/01/2013",6/19/2013,"06/19/2013"
"Drugs",65218,"Ongoing","Fresenius Kabi USA, LLC","Lake Zurich","IL","US","Voluntary: Firm Initiated","Letter","Nationwide","D-920-2013","Class I","Magnesium Sulfate Injection, USP, 50% (25 grams/50 mL), For IM or IV Use, 50 mL, Single Dose Vial, Rx only, Preservative Free, APP Pharmaceuticals, LLC, Schaumburg, IL, 60173, NDC 63323-064-50","Lot #: 6103882, Exp 10/14",,"15,625 vials","Presence of Particulate Matter: Glass particulate matter was observed in a retention sample during an annual review.",5/25/2013,"05/25/2013",9/4/2013,"09/04/2013"
"Biologics",65219,"Terminated","American National Red Cross","Columbus","OH","US","Voluntary: Firm Initiated","Other","California","B-2103-13","Class III","Blood and Blood Products for Reprocessing","16GY41376; ",".","1","Blood product, collected from a donor in whom donor suitability was not adequately determined, was distributed.",3/29/2013,"03/29/2013",8/28/2013,"08/28/2013"
"Biologics",65220,"Terminated","Community Blood Centers of South Florida, Inc.","Hialeah","FL","US","Voluntary: Firm Initiated","FAX","Michigan; Florida","B-2106-13","Class II","Fresh Frozen Plasma","W036812440893; W036811187949; W036811102262; ",".","3","Blood products, collected from a donor in whom donor suitability was not adequately determined, were distributed.",4/4/2013,"04/04/2013",8/28/2013,"08/28/2013"
"Biologics",65220,"Terminated","Community Blood Centers of South Florida, Inc.","Hialeah","FL","US","Voluntary: Firm Initiated","FAX","Michigan; Florida","B-2104-13","Class II","Red Blood Cells","W036812440893; W036811187949; W036811102262; ",".","3","Blood products, collected from a donor in whom donor suitability was not adequately determined, were distributed.",4/4/2013,"04/04/2013",8/28/2013,"08/28/2013"
"Biologics",65220,"Terminated","Community Blood Centers of South Florida, Inc.","Hialeah","FL","US","Voluntary: Firm Initiated","FAX","Michigan; Florida","B-2105-13","Class II","Platelets Pooled Leukocytes Reduced","W036812843172; W036811804772; ",".","2","Blood products, collected from a donor in whom donor suitability was not adequately determined, were distributed.",4/4/2013,"04/04/2013",8/28/2013,"08/28/2013"
"Biologics",65221,"Terminated","HCSC-Blood Center","Bethlehem","PA","US","Voluntary: Firm Initiated","Letter","Pennsylvania","B-2108-13","Class III","Fresh Frozen Plasma","W050912006948; ",".","1","Blood products, collected from donors for whom donor suitability was not adequately determined, were distributed. ",4/10/2013,"04/10/2013",8/28/2013,"08/28/2013"
"Biologics",65221,"Terminated","HCSC-Blood Center","Bethlehem","PA","US","Voluntary: Firm Initiated","Letter","Pennsylvania","B-2109-13","Class II","Platelets Pheresis Leukocytes Reduced Irradiated","W050912005655; ",".","1","Blood products, collected from donors for whom donor suitability was not adequately determined, were distributed. ",4/10/2013,"04/10/2013",8/28/2013,"08/28/2013"
"Biologics",65221,"Terminated","HCSC-Blood Center","Bethlehem","PA","US","Voluntary: Firm Initiated","Letter","Pennsylvania","B-2107-13","Class III","Red Blood Cells Leukocytes Reduced","W050912006948; ",".","1","Blood products, collected from donors for whom donor suitability was not adequately determined, were distributed. ",4/10/2013,"04/10/2013",8/28/2013,"08/28/2013"
"Biologics",65222,"Terminated","Community Blood Centers of South Florida, Inc.","Lake Worth","FL","US","Voluntary: Firm Initiated","FAX","Florida","B-2110-13","Class II","Red Blood Cells","2423919; ",".","1","Blood products, collected from a donor in whom donor suitability was not adequately determined, were distributed.",4/3/2013,"04/03/2013",8/28/2013,"08/28/2013"
"Biologics",65222,"Terminated","Community Blood Centers of South Florida, Inc.","Lake Worth","FL","US","Voluntary: Firm Initiated","FAX","Florida","B-2111-13","Class II","Platelets Pooled Leukocytes Reduced","2918705; ",".","1","Blood products, collected from a donor in whom donor suitability was not adequately determined, were distributed.",4/3/2013,"04/03/2013",8/28/2013,"08/28/2013"
"Devices",65223,"Ongoing"," AGFA Corp.","Greenville","SC","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution - US Nationwide including the states of AL, FL, IL, IN, IA, KY, MA, MI, MN, MS, MO, NE, NJ, NY, NC, OH, OR, SC, TN, VA, WV, WY and the country of Canada","Z-1487-2013","Class II","AGFA Digital Radiography X-Ray System DX-D 100 Agfa's DX-D 100 is indicated for use in providing diagnostic quality images to aid the physician with diagnosis. Systems can be used with MUSICA2 image processing to create radiographic images of the skeleton including skull, spinal column and extremities: chest, abdomen, and other body parts. ","Material numbers in US - 5Q82F, 5R75Q, 5Q8ZB, 5R77U & 58Q1D - Material numbers in Canada - 5R78W & 5R77U",".","104","Customers could potentially experience intermittent, unintended and illogical movement when using the product.",5/15/2013,"05/15/2013",6/12/2013,"06/12/2013"
"Devices",65224,"Ongoing","Siemens Healthcare Diagnostics, Inc","East Walpole","MA","US","Voluntary: Firm Initiated","Letter","Nationwide Distribution.","Z-1512-2013","Class II","ADVIA Centaur iPTH ReadyPack Assay 100 Tests; REF 10492368. For in vitro diagnostic use in the quantitative determination of intact parathyroid hormone (iPTH).","Reagent Lot Number: 056301 and 56302 Kit Lot Number/Exp. Date: 61655301 09 Nov 2011 61950302 09 Nov 2011",".","309 (100 test) kits","iPTH Assay- reagent and calibrator lots may have demonstrated higher than anticipated variability",5/14/2013,"05/14/2013",6/12/2013,"06/12/2013"
"Devices",65224,"Ongoing","Siemens Healthcare Diagnostics, Inc","East Walpole","MA","US","Voluntary: Firm Initiated","Letter","Nationwide Distribution.","Z-1515-2013","Class II","ADVIA Centaur iPTH Calibrator 6 pk; REF: 10492387, 10630628. For in vitro diagnostic use in calibrating Intact PTH assays.","Calibrator Lot Numbers: C5601, C5602 and C5603 Kit Lot Number/Exp. Date: REF 10492387 - 6 pk 61404A01 27 Oct 2011 66516A02 27 Oct 2011 66610A02 27 Oct 2011 67824B02 27 Oct 2011 70657B02 27 Oct 2011 74448A03 13 Jul2012 REF 10630628 - 6 pk 668748B02 27 Oct 2011 68015B02 27 Oct 2011 72400B02 27 Oct 2011 74449B02 27 Oct 2011",".","198 (6 pk)","iPTH Assay- reagent and calibrator lots may have demonstrated higher than anticipated variability",5/14/2013,"05/14/2013",6/12/2013,"06/12/2013"
"Devices",65224,"Ongoing","Siemens Healthcare Diagnostics, Inc","East Walpole","MA","US","Voluntary: Firm Initiated","Letter","Nationwide Distribution.","Z-1513-2013","Class II","ADVIA Centaur iPTH ReadyPack Assay 500 Tests; REF 10492369, 10493615, 1049361. For in vitro diagnostic use in the quantitative determination of intact parathyroid hormone (iPTH).","Reagent Lot Numbers: 056301 and 56302 Kit Lot Number/Exp. Date: REF 10492369- 500 Tests 61639301 09 Nov 2011 REF 1 0493615 - 500 Tests 63607301 09 Nov 2011 68004301 09 Nov 2011 70229301 09 Nov 2011 74126301 09Nov2011 REF 10493616-500 Tests 62645302 09 Nov 2011 66612302 09 Nov 2011 74129302 09 Nov 2011",".","3302 Kits (500 test)","iPTH Assay- reagent and calibrator lots may have demonstrated higher than anticipated variability",5/14/2013,"05/14/2013",6/12/2013,"06/12/2013"
"Devices",65224,"Ongoing","Siemens Healthcare Diagnostics, Inc","East Walpole","MA","US","Voluntary: Firm Initiated","Letter","Nationwide Distribution.","Z-1514-2013","Class II","ADVIA Centaur iPTH Calibrator 2 pk; REF 10492394. For in vitro diagnostic use in calibrating Intact PTH assays.","Calibrator Lot Number: C5601 and C5602 Kit Lot Number/Exp. Date: 61405A01 27 Oct 2011 66517A02 27 Oct 2011 66611A02 27 Oct 2011 71997C02 27 Oct 2011",".","99 (2 pk)","iPTH Assay- reagent and calibrator lots may have demonstrated higher than anticipated variability",5/14/2013,"05/14/2013",6/12/2013,"06/12/2013"
"Drugs",65225,"Ongoing","Hospira Inc.","Lake Forest","IL","US","Voluntary: Firm Initiated","Letter","Nationwide and Puerto Rico","D-502-2013","Class II","DOBUTamine in 5% Dextrose Injection, USP, 250 mg Total, 1000 mcg/mL 250 mL bag, Rx only, HOPIRA, INC., LAKE FOREST, IL 60045 NDC 0409-2346-32","Lot 11-309-KL",".","44,748 bags","Lack of Assurance of Sterility: Confirmed report of leaking in the primary container.",4/30/2013,"04/30/2013",6/12/2013,"06/12/2013"
"Drugs",65226,"Ongoing","Hospira Inc.","Lake Forest","IL","US","Voluntary: Firm Initiated","Letter","Nationwide","D-686-2013","Class II","Gentamicin Sulfate Injection USP 80 mg/2mL(40 mg/mL as Gentamicin), 2 mL Single-dose Fliptop Vial, (NDC 0409-1207-13), Rx only, Manufactured by Hospira, Inc, Lake Forest, IL 60046 USA.","Lot 07-067-DK Exp. 07/13",".","168,300 vals","Presence of Particulate Matter: Confirmed customer report where visible particles were identified floating in the primary container.",5/2/2013,"05/02/2013",7/17/2013,"07/17/2013"
"Food",65227,"Ongoing","Chs Inc","Inver Grove Heights","MN","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Nationwide. Product was shipped from the Israel facility to the following countries. This product did not come into the U.S. before shipment to the following countries: Canada, Australia, Belgium, Brazil, Bulgaria, Chile, Columbia, Costa Rica, Czech Republic, Denmark, Finland, France, Germany, Greece, Guatemala, Hungary, India, Israel, Italy, Japan, Lithuania, Mauritius, Mexico, Netherlands, New Zealand, Panama, Poland, Portugal, Romania, Russia, Serbia, Slovakia, Slovenia, South Africa, South Korea, Spain, Taiwan, Thailand, United Kingdom, Uruguay, and Vietnam","F-1641-2013","Class II","Contex - Textured Soy Protein Concentrates Item No. / Item Description: 3411112 / Contex 120 Textured Soy Protein, 3411124 / Contex 25 Textured Soy Protein, 3411129 / Contex 31 CL Textured Soy Protein, 3411142 / Contex 120CL IP Textured Soy Protein, 3411144 / Contex 240 Textured Soy Protein, 3411161 / Contex 25 CLH, 51026 / Contex 25 Textured NGMO Soy Protein, 52031 / Contex 31 GMO Textured Soy Protein, 52032 / Contex 31 CL GMO Textured Soy Protein, 52034 / Contex 31PV GMO Textured Soy Protein, 52035 / Contex 31NP GMO Textured Soy Protein, 52121 / Contex 120CL IP Textured Soy Protein, and 52248 / Contex 240CL GMO Textured Soy Protein. ","Item No. 3411112, Batch Codes: C120031012, C120080413, C120080911, C120110213, C120110213/1, C120161111/1, C120171111, C120180412, C120190112, C120221012, C120240811, C120270612, C120280612, C120300512, C120310512. Item No. 3411124 , Batch Code: C25190911 Item No. 3411129 , Batch Codes: C31CL051212, C31CL150113/1 Item No. 3411142, Batch Code NC120CL230611 Item No. 3411144, Batch Codes: C240060512, C240220512, C240261112 Item No. 3411161 Batch Code PDC25CLH240512 Item No. 51026, Batch Codes: NC25070911, NC2522061, NC25251212. Item No. 52031, Batch Codes: 7100712, C31081111, C31090212, C31120112, C31170111, C31200512, C31200911, C31210611, C31240712, C31250911, C31251112, C31270911. Item No. 52032, Batch Code: C31CL271112 Item No. 52034, Batch Codes: C31PV050511, C31PV140611, C31PV150611, C31PV160611. Item No. 52035, Batch Codes: C31NP030511, C31NP110511, C31NP160611, C31NP180711, C31NP220511, C31NP220511/C31NP110511. Item No. 52121, Batch Codes: NC120CL160212, NC120CL170511, NC120CL200612, NC120CL230611. Item No. 52248, Batch Code: C240CL070212, C240CL070512, C240CL240512, C240CL260712, C240CL261112, C240CL281012. ",".","651,225 kilograms","Certain Soy-based products produced at the Ashdod Israel production facility have the potential to be contaminated with Salmonella",5/16/2013,"05/16/2013",7/17/2013,"07/17/2013"
"Food",65227,"Ongoing","Chs Inc","Inver Grove Heights","MN","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Nationwide. Product was shipped from the Israel facility to the following countries. This product did not come into the U.S. before shipment to the following countries: Canada, Australia, Belgium, Brazil, Bulgaria, Chile, Columbia, Costa Rica, Czech Republic, Denmark, Finland, France, Germany, Greece, Guatemala, Hungary, India, Israel, Italy, Japan, Lithuania, Mauritius, Mexico, Netherlands, New Zealand, Panama, Poland, Portugal, Romania, Russia, Serbia, Slovakia, Slovenia, South Africa, South Korea, Spain, Taiwan, Thailand, United Kingdom, Uruguay, and Vietnam","F-1640-2013","Class II","Solcon S Functional Soy Protein Concentrates. Item No. / Item Description: 3232212 / Solcon S 110 GMO, and 32211 / Solcon S110 GMO ","Item No. 3232212, Batch Codes: SS110010113, SS110030113, SS110111212/1, SS110271212. Item No. 32211, Batch Codes: SS110150812, SS110160712, SS110170712, SS110180712, SS110210612, SS110220612, SS110280812. ",".","161,400 killograms","Certain Soy-based products produced at the Ashdod Israel production facility have the potential to be contaminated with Salmonella",5/16/2013,"05/16/2013",7/17/2013,"07/17/2013"
"Food",65227,"Ongoing","Chs Inc","Inver Grove Heights","MN","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Nationwide. Product was shipped from the Israel facility to the following countries. This product did not come into the U.S. before shipment to the following countries: Canada, Australia, Belgium, Brazil, Bulgaria, Chile, Columbia, Costa Rica, Czech Republic, Denmark, Finland, France, Germany, Greece, Guatemala, Hungary, India, Israel, Italy, Japan, Lithuania, Mauritius, Mexico, Netherlands, New Zealand, Panama, Poland, Portugal, Romania, Russia, Serbia, Slovakia, Slovenia, South Africa, South Korea, Spain, Taiwan, Thailand, United Kingdom, Uruguay, and Vietnam","F-1638-2013","Class I","Solbar Q Soy Protein Isolates. Item No. / Item Description: 22843 / Solbar Q 843 GMO, 22910 / Solbar Q 910 GMO, 22942 / Solbar Q 842 GMO, 22943 / Solbar Q 842 NGMO, 3323912 / Solbar Q 910, 3323920 / Solbar Q 920, 3323932 / Solbar Q 842, and 3323973 / Solbar Q 842 IP ","Item No.22843, Batch Code: PDSP843040712 Item No. 22910, Batch Codes: SP910031212, SP910071212, SP910090812, SP910201112, SP910260612, SP910270412, SP910270612, SP910300712. Item No. 22942, Batch Codes: sp842010113, SP842010512, SP842010712, SP842030812, SP842040212, SP842040812, SP842041111, SP842050812, SP842071111, SP842090212, SP842090712, SP842100212, SP842100712, SP842140212, SP842141112, SP842160112, SP842160212, SP842170112, SP842180112, SP842190712, SP842200212, SP842200712, SP842201111, SP842220712, SP842220912, SP842230612, SP842230912, SP842260112, SP842270112, SP842270412, SP842280112, SP842290112, SP842290412, SP842300412. Item No. 22943, Batch Codes: NSP842080412, NSP842280312, NSP842280312/1, NSP842280312/2. Item No. 3323912, Batch Codes: SP910241012/2, SP910251112, SP910271212, SP910281212.SP910311212. Item No. 3323920, Batch Codes: SP920090812, SP920200313, SP920211012/1, SP920220512, SP920221012, SP920290512. Item No. 3323932, Batch Codes: SP842010113, SP842010113/1, SP842010313, SP842030213/1, SP842030812, SP842031112, SP842040212/R, SP842040213, SP842040213/1, SP842041112, SP842061112/1, SP842070213, SP842071111/2, SP842071112, SP842071112/1, SP842080213, SP842080413/2, SP842081112/1, SP842090213, SP842090413/2, SP842090413/3, SP842091112, SP842091112/1, SP842101112, SP842110213, SP842110213/1, SP842120213, SP842120213/1, SP842121112, SP842130213, SP842131112, SP842131112/1, SP842140213, SP842141112, SP842141112/3, SP842150213, SP842160213, SP842161112, SP842170213, SP842171112, SP842171112/1, SP842200912, SP842240113, SP842250612, SP842260213, SP842270213, SP842270213/1, SP842280113/1, SP842280213, SP842280213/1, SP842280213/2, SP842290113, SP842290113/2, SP842290113/3, SP842290113/4, SP842290113/5, SP842311212/1, SP842311212/2. Item No. 3323973, Batch Codes: NSP842120113, NSP842120113/1, NSP842120113/2, NSP842130113, NSP842140113, NSP842140113/1, NSP842170113/1, NSP842190113.",".","1,671,960 kilograms","Certain Soy-based products produced at the Ashdod Israel production facility have the potential to be contaminated with Salmonella",5/16/2013,"05/16/2013",7/17/2013,"07/17/2013"
"Food",65227,"Ongoing","Chs Inc","Inver Grove Heights","MN","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Nationwide. Product was shipped from the Israel facility to the following countries. This product did not come into the U.S. before shipment to the following countries: Canada, Australia, Belgium, Brazil, Bulgaria, Chile, Columbia, Costa Rica, Czech Republic, Denmark, Finland, France, Germany, Greece, Guatemala, Hungary, India, Israel, Italy, Japan, Lithuania, Mauritius, Mexico, Netherlands, New Zealand, Panama, Poland, Portugal, Romania, Russia, Serbia, Slovakia, Slovenia, South Africa, South Korea, Spain, Taiwan, Thailand, United Kingdom, Uruguay, and Vietnam","F-1639-2013","Class II","Solcon Soy Protein Concentrates. Item No. / Item Description: 12110 / Solcon F GMO, 3112030 / Solcon F Soy Protein Concentrate, 12100 / Solcon GMO, and 3112002 / Solcon GMO Soy Protein Concentrate ","Item No. 12110, Batch Codes: SF011111, SF040811, SF121111, SF130112, SF131111, SF131212, SF140112, SF180712, SF190612, SF210512, SF240112, SF251011, SF251112, , SF310511. Item No. 3112030, Batch Codes: SF190911, SF200313, SF251112, SF270113, SF270711/1. Item No. 12100, Batch Codes: S010812, S020612, S020712, S020812, S021211, S030412, S030612, S040412, S050112, S050712, S060212, S060612, S061211, S080512, S080812, S090812, S100312, S110312, S120812, S120912, S130912, S140811, S150112, S150512, S150912, S151211, S160112, S160512, S160812, S161012, S170512, S180612, S181012, S200512, S200612, S210512, S210612, S220312, S220712, S230712, S240412, S240612, S240712, S250512, S250612, S250712, S260412, S260612, S270312, S270412, S270612, S280512, S280612, S281012, S300312, S300712, S310512. Item No. 3112002, Batch Codes: S011112, S041112, S050213, S051112, S051112/1, S060213, S061112, S061212, S061212/1, S070213, S071112/1, S071212, S101112, S111012, S111212, S111212/1, S121012, S121112, S130912/1, S131112, S151112, S151112/1, S161112, S191212, S200512, S201012, S201212, S201212/1, S221012, S230113, S230113/1, S231012, S231012/1, S241012, S241112, S251012, S251112, S261012, S261112, S281012/1, S291112, S300113, S301112. ",".","2,536,725 kilograms","Certain Soy-based products produced at the Ashdod Israel production facility have the potential to be contaminated with Salmonella",5/16/2013,"05/16/2013",7/17/2013,"07/17/2013"
"Devices",65229,"Ongoing","GE Healthcare, LLC","Waukesha","WI","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution - USA including CA, CO, CT, FL, GA, IL, NY, NY NC OH, TX, VA, WV, WI. Internationally to: AUSTRALIA, AUSTRIA, BAHARIN, CANADA, CHILE, CHINE, CZECH REPUBLIC, DENMARK, FINLAND, FRANCE, GEORGIA, GERMANY, HONG KONG, INDIA, INDONESIA, ITALY, JAPAN, KOREA, MEXICO, MOROCCO, NIGERIA, POLAND, ROMANIA, RUSSIA,SAUDI ARABIA, SOUTH AFRICA, SPAIN, SWEDEN, SWITZERLAND, TAIWAN, THAILAND, TURKEY, UNITED KINGDOM.","Z-1551-2013","Class II","GE Healthcare, PET VCAR. PET VCAR application software is affected if installed on any of the following versions of the Advantage Workstation and AW Server: Advantage Workstation 4.6, Volume Share 5 enhanced vxtl.11.3, vxtl.11.3 ext1, or vxtl.11.3 ext2 AW Server 2.0, Volume Share 5 enhanced vxtl.11.3, vxtl.11.3 ext1, or vxtl.11.3 ext2 PET VCAR (Volume Computer Assisted Reading) is a PET/CT software package which can be used by the clinician to assist in diagnosis, staging, treatment planning and monitoring treatment response. ","Mfg Lot or Serial # 00000L3A331FA4 00000L3A3318C4 0S804VCUPETAWS 00S804VCUPETAW 00000LE23E908A 00000LA707B8CD 0000S704783AWS 00000L3AB67847 000D1L3AB67847 00000LA70D61FE 0000G297117701 00000LFB44C088 00000LA70D6257 00000L2E5D97AC 00000LA704C3E7 00000L021DFE17 00000L97BF02A6 00000L3AA73A5B 00000LA70AB28E 00000L3AB4D639 00000L3AB501ED 00000L3AA80D28 00000L3AB4D6CC 00000L3AB50126 SNYPHAWSERVER2 00000X12335005 00000LAEDF9764 000S704783HDCT 0D1S704783HDCT SSENTARAPETDST 00000LB8CDB088 00000LA70CF2BD 00S681342AWONC 00000L97BD2680 0S856247PETUPS 00000L3AAD0E3F 00000L3A6AB2B5 00000L3A3D0C38 00000LA7053E64 00000LA7053E11 00000H12361003 00000H12361004 0000AD13018005 00000E12291003 00000E12291004 0000AV12212003 0000AV12212004 0000AV12213001 0000AV12213002 00000R12268002 00000R12268003 00000N12226004 00000N12226005 00000L3A330899 00000L3A87FE86 00000L3A86843C 00000L3A3305A1 00000LA713783D 00000LA712A01B 00000LA7142C7C SCT428868CN4AW 00000L3AA6F64A 00000X12335002 00000Q12328002 00000Q12328001 00000H12361005 0000AP12152002 0000AP12152001 00000L02135882 00000L0257B5A9 00000L026873C9 00000L3AB68D6E 00000L12130007 00000LA7053E56 000D1LA7053E56 00000L3AADF306 00000Q13066002 00000Y13070003 00000L026F4B0A 00000R12268005 00000L3A8FD336 00000L12130001 00000L12130002 00000L02167931 00000LA707FDCA 00000LA707FDC7 00000L02687367 00000L3A373C91 00000L020E0B5F 00000LA8CE7F5A 00000L02687172 00000L3AB1FAF2 00000L021500C2 00000Y13070001 0000AE12073008 00000H12275003 00000N12226001 00000L12130003 00000L12130004 00000L12130005 00000L12130006 00000P12319006 00000P12319004 0000AG12311002 00000L12130010 00000X12335004 00000P12319007 00000X12335003 00000Q12328003 0000AE12073003 0000AV12227003 00000H12361002 00000G12164003 00000L024087F6 00000E12291002 0000AD13018004 00000U12145004 00000U12145001 0000AP12152003 0000AP12152004 00000R12268001 00000H12275001 00000J12283001 0000AE12073005 0000AD13018002 00000LA70D6AAB 00000L2E5",,"231 (38 US; 193 OUS)","GE Healthcare has recently become aware of a potential safety issue with respect to the automated PERCIST response criteria calculation applied in the PET VCAR application on Advantage Workstation or AW Server.",5/9/2013,"05/09/2013",6/26/2013,"06/26/2013"
"Food",65230,"Ongoing","Jus Made, Inc","Dallas","TX","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","TX, NC, AR, AL, KY, MO, and GA","F-1539-2013","Class II","Roo's Juice Tropical Orange Flavor (5% juice beverage) 10 FL OZ. (296 mL) Distributed by The Pantry, Inc. Sanford, NC 27330","Item: OR047-RTU; Lot J3119, 2013-10874",,"1,995 cases","The product has the potential to contain polysaccharide-based bacterial biofilm, mold, and red water mites.",5/21/2013,"05/21/2013",6/26/2013,"06/26/2013"
"Biologics",65231,"Terminated","Community Blood Center","Dayton","OH","US","Voluntary: Firm Initiated","FAX","Indiana","B-2001-13","Class III","Blood and Blood Products for Reprocessing","W035413009699",,"1 unit","Blood product, collected from a donor who was at risk for variant Creutzfeldt-Jakob Disease (vCJD), was distributed.",5/1/2013,"05/01/2013",7/31/2013,"07/31/2013"
"Biologics",65232,"Terminated","CryoLife, Inc.","Kennesaw","GA","US","Voluntary: Firm Initiated","Letter","Pennsylvania; Nebraska; Indiana","B-1983-03","Class III","Vascular Graft","9863824; 9863853; 9863911",".","3 allografts ","Vascular grafts, recovered from a donor whose donor eligibility determination failed to ensure that the donor was free from risk factors for, and clinical evidence of infection due to relevant communicable disease agents and diseases, were distributed. ",5/17/2013,"05/17/2013",7/24/2013,"07/24/2013"
"Biologics",65233,"Terminated","CryoLife, Inc.","Kennesaw","GA","US","Voluntary: Firm Initiated","Letter","New York","B-1942-13","Class III","Cardiac Tissue, Non-valved","9985176; 9985185",".","2 allografts","Cardiac grafts, recovered from a donor whose donor eligibility determination failed to ensure that the donor was free from risk factors for, and clinical evidence of infection due to relevant communicable disease agents and diseases, were distributed. ",5/17/2013,"05/17/2013",7/24/2013,"07/24/2013"
"Biologics",65234,"Terminated","CryoLife, Inc.","Kennesaw","GA","US","Voluntary: Firm Initiated","Letter","New York; West Virginia; Indiana","B-1996-13","Class III","Cardiac Tissue, Non-valved","9962099",".","1 allograft","Human tissue allografts, recovered from a donor whose donor eligibility determination failed to ensure that the donor was free from risk factors for, and clinical evidence of infection due to relevant communicable disease agents and diseases, was distributed.",5/17/2013,"05/17/2013",7/24/2013,"07/24/2013"
"Biologics",65234,"Terminated","CryoLife, Inc.","Kennesaw","GA","US","Voluntary: Firm Initiated","Letter","New York; West Virginia; Indiana","B-1995-13","Class III","Vascular Graft","9962023",".","1 allograft","Human tissue allografts, recovered from a donor whose donor eligibility determination failed to ensure that the donor was free from risk factors for, and clinical evidence of infection due to relevant communicable disease agents and diseases, was distributed.",5/17/2013,"05/17/2013",7/24/2013,"07/24/2013"
"Biologics",65234,"Terminated","CryoLife, Inc.","Kennesaw","GA","US","Voluntary: Firm Initiated","Letter","New York; West Virginia; Indiana","B-1997-13","Class III","Heart Valve","9962113",".","1 unit","Human tissue allografts, recovered from a donor whose donor eligibility determination failed to ensure that the donor was free from risk factors for, and clinical evidence of infection due to relevant communicable disease agents and diseases, was distributed.",5/17/2013,"05/17/2013",7/24/2013,"07/24/2013"
"Biologics",65235,"Terminated","CryoLife, Inc.","Kennesaw","GA","US","Voluntary: Firm Initiated","Letter","California; Texas","B-1751-13","Class III","Vascular Graft","9832390; 9832483; 9840388",".","3 allografts","Vascular grafts, recovered from a donor whose donor eligibility determination failed to ensure that the donor was free from risk factors for, and clinical evidence of infection due to relevant communicable disease agents and diseases, were distributed. ",5/17/2013,"05/17/2013",7/24/2013,"07/24/2013"
"Biologics",65236,"Terminated","CryoLife, Inc.","Kennesaw","GA","US","Voluntary: Firm Initiated","Letter","Canada; South Carolina; Florida","B-1994-13","Class III","Cardiac Tissue, Non-valved","9860511",".","1 allograft","Human tissue allograft, recovered from a donor whose donor eligibility determination failed to ensure that the donor was free from risk factors for, and clinical evidence of infection due to relevant communicable disease agents and diseases, was distributed. ",5/17/2013,"05/17/2013",7/24/2013,"07/24/2013"
"Biologics",65236,"Terminated","CryoLife, Inc.","Kennesaw","GA","US","Voluntary: Firm Initiated","Letter","Canada; South Carolina; Florida","B-1993-13","Class III","Vascular Graft","9860472",".","1 allograft","Human tissue allograft, recovered from a donor whose donor eligibility determination failed to ensure that the donor was free from risk factors for, and clinical evidence of infection due to relevant communicable disease agents and diseases, was distributed. ",5/17/2013,"05/17/2013",7/24/2013,"07/24/2013"
"Biologics",65236,"Terminated","CryoLife, Inc.","Kennesaw","GA","US","Voluntary: Firm Initiated","Letter","Canada; South Carolina; Florida","B-1992-13","Class III","Heart Valve","9860382",".","1 allograft","Human tissue allograft, recovered from a donor whose donor eligibility determination failed to ensure that the donor was free from risk factors for, and clinical evidence of infection due to relevant communicable disease agents and diseases, was distributed. ",5/17/2013,"05/17/2013",7/24/2013,"07/24/2013"
"Biologics",65238,"Terminated","CryoLife, Inc.","Kennesaw","GA","US","Voluntary: Firm Initiated","Letter","Michigan; Maryland; Texas; Minnesota","B-1988-13","Class III","Vascular Graft","10022449; 10022514; 10022551",".","3 units","Human tissue allografts, recovered from a donor whose donor eligibility determination failed to ensure that the donor was free from risk factors for, and clinical evidence of infection due to relevant communicable disease agents and diseases, were distributed. ",5/17/2013,"05/17/2013",7/24/2013,"07/24/2013"
"Biologics",65238,"Terminated","CryoLife, Inc.","Kennesaw","GA","US","Voluntary: Firm Initiated","Letter","Michigan; Maryland; Texas; Minnesota","B-1990-13","Class III","Cardiac Tissue, Non-valved","10022525",".","1 unit","Human tissue allografts, recovered from a donor whose donor eligibility determination failed to ensure that the donor was free from risk factors for, and clinical evidence of infection due to relevant communicable disease agents and diseases, were distributed. ",5/17/2013,"05/17/2013",7/24/2013,"07/24/2013"
"Biologics",65238,"Terminated","CryoLife, Inc.","Kennesaw","GA","US","Voluntary: Firm Initiated","Letter","Michigan; Maryland; Texas; Minnesota","B-1989-13","Class III","Heart Valve","10022483",".","1 unit","Human tissue allografts, recovered from a donor whose donor eligibility determination failed to ensure that the donor was free from risk factors for, and clinical evidence of infection due to relevant communicable disease agents and diseases, were distributed. ",5/17/2013,"05/17/2013",7/24/2013,"07/24/2013"
"Biologics",65239,"Terminated","CryoLife, Inc.","Kennesaw","GA","US","Voluntary: Firm Initiated","Letter","California; Texas","B-1938-13","Class III","Vascular Graft","9984625; 9984638",".","2 allografts","Human vascular allografts, recovered from a donor whose donor eligibility determination failed to ensure that the donor was free from risk factors for, and clinical evidence of infection due to relevant communicable disease agents and diseases, were distributed. ",5/17/2013,"05/17/2013",7/24/2013,"07/24/2013"
"Biologics",65241,"Terminated","CryoLife, Inc.","Kennesaw","GA","US","Voluntary: Firm Initiated","Letter","Louisiana; Georgia","B-1937-13","Class III","Heart Valve","9951484; 9951491",".","2 allografts ","Heart Valves, recovered from a donor whose donor eligibility determination failed to ensure that the donor was free from risk factors for, and clinical evidence of infection due to relevant communicable disease agents and diseases, were distributed. ",5/17/2013,"05/17/2013",7/24/2013,"07/24/2013"
"Biologics",65242,"Terminated","CryoLife, Inc.","Kennesaw","GA","US","Voluntary: Firm Initiated","Letter","Canada; New York","B-1936-13","Class III","Cardiac Tissue, Non-valved","9799209; 9856929",".","2 allografts ","Cardiac tissue allografts, recovered from a donor whose donor eligibility determination failed to ensure that the donor was free from risk factors for, and clinical evidence of infection due to relevant communicable disease agents and diseases, were distributed. ",5/17/2013,"05/17/2013",7/24/2013,"07/24/2013"
"Devices",65243,"Ongoing","Becton Dickinson & Company","Franklin Lakes","NJ","US","Voluntary: Firm Initiated","E-Mail","Worldwide Distribution including US Nationwide and the countries of Canada and Suriname.","Z-1577-2013","Class II","BD SafetyGlide Allergy. REF 305950 Sterile Allergy Treatment Syringe Tray. The device is used for aspiration and injection of medications.","Catalog/Lot Number: REF#305950 Lot 2132028 and Lot 2159189",,"1,326,000 units","There has been an increase in complaints regarding the needle/safety mechanism disengaging from the syringe.",5/1/2013,"05/01/2013",7/3/2013,"07/03/2013"
"Drugs",65244,"Ongoing","Pharmalucence, Inc.","Billerica ","MA","US","Voluntary: Firm Initiated","Letter","Nationwide & Bahamas, Barbados, Bermuda, Japan","D-808-2013","Class III","Pharmalucence Kit for the Preparation of Technetium Tc 99m Sestamibi Injection for Mycardial and Breast Imaging. For Intravenous Use and Reconstitution. a) Five vials kits: NDC# 45567-0555-1, b) Thirty vials kits: NDC# 45567-0555-2, Rx Only, Manufactured by: Pharmalucence, Inc., Billerica, MA 01821 ","Lot 280011, Exp 08/13",,"17,260 vials","Presence of Particulates; particulate found in retain sample",5/30/2013,"05/30/2013",7/31/2013,"07/31/2013"
"Devices",65245,"Ongoing","IDEV Technologies, Inc.","Webster","TX","US","Voluntary: Firm Initiated","Telephone","Nationwide Distribution to the states of FL, NY, and PA.","Z-1550-2013","Class II","IDEV Technologies SUPERA VERITAS Interwoven Self-Expanding Nitinol Stent Transhepatic Biliary System. Indicated for palliative treatment of biliary strictures produced by malignant neoplasms","Model Number: S-05-100-120-G3; Lot Number 01049037",,"3","There was an error on the outer labeling of this device. The inner label was correct.",5/29/2012,"05/29/2012",6/26/2013,"06/26/2013"
"Devices",65246,"Ongoing","Roche Diagnostics Operations, Inc.","Indianapolis","IN","US","Voluntary: Firm Initiated","Letter","Nationwide Distribution","Z-1584-2013","Class II","CoaguChek XS System (HCP) The CoaguChek XS System is intended for use by professional healthcare providers for quantitative prothrombin time testing for the monitoring of warfarin therapy. ","Model/Catalog/Part Number: 04837975001 and 04625412160",,"86553 meters","Roche has confirmed the potential for an undetected elevated INR test result with the CoaguChek XS, CoaguChek XS Plus, and CoaguChek XS Pro meters. In rare cases, instead of a value, an ERROR 6 message is displayed.",5/16/2013,"05/16/2013",7/3/2013,"07/03/2013"
"Devices",65246,"Ongoing","Roche Diagnostics Operations, Inc.","Indianapolis","IN","US","Voluntary: Firm Initiated","Letter","Nationwide Distribution","Z-1582-2013","Class II","CoaguChek XS Pro System The CoaguChek XS Pro System (CoaguChek XS Pro meter and CoaguChek XS PT Test strips) quantitatively determines prothrombin time (''PT''), using capillary blood or whole blood from a vein (non anticoagulated venous whole blood).","Model/Catalog/Part Number: 05530199160",,"537 meters total","Roche has confirmed the potential for an undetected elevated INR test result with the CoaguChek XS, CoaguChek XS Plus, and CoaguChek XS Pro meters. In rare cases, instead of a value, an ERROR 6 message is displayed.",5/16/2013,"05/16/2013",7/3/2013,"07/03/2013"
"Devices",65246,"Ongoing","Roche Diagnostics Operations, Inc.","Indianapolis","IN","US","Voluntary: Firm Initiated","Letter","Nationwide Distribution","Z-1581-2013","Class II","CoaguChek XS System (PST) The CoaguChek XS PT test strips are part of the CoaguChek XS System. The CoaguChek XS System measures blood-clotting time for people who are taking anticoagulation medications such as Coumadin or warfarin.","Model/Catalog/Part Number: 04837738001",,"204,205 meters total","Roche has confirmed the potential for an undetected elevated INR test result with the CoaguChek XS, CoaguChek XS Plus, and CoaguChek XS Pro meters. In rare cases, instead of a value, an ERROR 6 message is displayed.",5/16/2013,"05/16/2013",7/3/2013,"07/03/2013"
"Devices",65246,"Ongoing","Roche Diagnostics Operations, Inc.","Indianapolis","IN","US","Voluntary: Firm Initiated","Letter","Nationwide Distribution","Z-1583-2013","Class II","CoaguChek XS Plus System The CoaguChek XS Plus system for use by professional healthcare providers for quantitative prothrombin time testing for the monitoring of warfarin therapy.","Model/Catalog/Part Number: 05021537001",,"3343 meters ","Roche has confirmed the potential for an undetected elevated INR test result with the CoaguChek XS, CoaguChek XS Plus, and CoaguChek XS Pro meters. In rare cases, instead of a value, an ERROR 6 message is displayed.",5/16/2013,"05/16/2013",7/3/2013,"07/03/2013"
"Devices",65247,"Ongoing","Ortho-Clinical Diagnostics","Rochester","NY","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Worldwide Disribution - USA Nationwide including Puerto Rico, and the countries of Australia, Bermuda, Brazil, Canada, Chile, China, Colombia, England, France, Germany, India, Italy, Japan, Mexico, Republic of Panama, Singapore, Spain and Venezuela.","Z-1615-2013","Class III","VITROS Chemistry Products CRP Slides (Reagent), REF/Catalog Number 192 6740 and 809 7990, Product Usage: For in vitro diagnostic use only. VITROS Chemistry Products CRP Slides quantitatively measure C-reactive protein (CRP) concentration in serum and plasma using VITROS 250/350/950/5,1 FS and 4600 Chemistry Systems and the VITROS 5600 Integrated System.","GEN 3773, Coating 0766, Lot XXXX (exp. 11/01/2013); GEN 3784, Coating 0767, Lot XXXX (exp. 11/01/2013); and GEN 3785, Coating 0768, Lot XXXX (exp. 10/01/2013 and 11/01/2013). The term GEN and Coating refer to specific segments of the reagent lot number.",,"Domestic: 4,257; Foreign: 923","While performing interval testing Ortho Clinical Diagnostics (OCD) determined that an excess amount of surfactant was unintentionally added to VITROS Chemistry Products CRP Slides during the manufacturing process.",5/9/2013,"05/09/2013",7/3/2013,"07/03/2013"
"Devices",65247,"Ongoing","Ortho-Clinical Diagnostics","Rochester","NY","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Worldwide Disribution - USA Nationwide including Puerto Rico, and the countries of Australia, Bermuda, Brazil, Canada, Chile, China, Colombia, England, France, Germany, India, Italy, Japan, Mexico, Republic of Panama, Singapore, Spain and Venezuela.","Z-1614-2013","Class III","VITROS Chemistry Products K+ (Potassium) Slides (Reagent), REF/Catalog Number 815 7596, Product Usage: For in vitro diagnostic use only. VITROS Chemistry Products K+ Slides quantitatively measure potassium (K+) concentration in serum, plasma, and urine using VITROS 250/350/950/5,1 FS and 4600 Chemistry Systems and the VITROS 5600 Integrated System. ","GEN 4102, Coating 0884, Lot XXXX (exp. 06/01/2014) and GEN 4102, Coating 0885, Lot XXXX (exp. 06/01/2014 and 07/01/2014). The term GEN and Coating refer to specific segments of the reagent lot number.",,"Domestic: 236,364; Foreign: 8,339","While performing interval testing, Ortho Clinical Diagnostics (OCD) determined that a surfactant was unintentionally added to VITROS Chemistry Products K+ Slides during the manufacturing process.",5/9/2013,"05/09/2013",7/3/2013,"07/03/2013"
"Devices",65248,"Ongoing","Endologix Inc","Irvine","CA","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution - USA Nationwide in the states of: NY, NH, IN, MI, FL and NJ and in the countries of: Europe and Latin America.","Z-1436-2013","Class I","Brand Name: AFX'' Introducer System, Model Number S17-45. Lot Numbers: 1079840, 1079843, 1079844, 1079845. Product Usage: The AFX Introducer System is intended for use to facilitate the introduction of catheters and other medical devices into the vasculature and to minimize blood loss associated with such introduction. ","Model Number S17-45. Lot Numbers: 1079840, 1079843, 1079844, 1079845",".","53","Endologix, Inc. initiated this voluntary recall of certain lots of Endologix, Inc. due to reports of dilator breakage during clinical procedures.",5/13/2013,"05/13/2013",6/19/2013,"06/19/2013"
"Biologics",65249,"Terminated","BloodSource, Inc.","Mather","CA","US","Voluntary: Firm Initiated","Telephone","Austria; New York","B-2112-13","Class II","Red Blood Cells Leukocytes Reduced","LE33722; ",".","1","Blood products, collected from an ineligible donor, were distributed",5/9/2013,"05/09/2013",8/28/2013,"08/28/2013"
"Biologics",65249,"Terminated","BloodSource, Inc.","Mather","CA","US","Voluntary: Firm Initiated","Telephone","Austria; New York","B-2113-13","Class II","Blood and Blood Products for Reprocessing","LE33722; ",".","1","Blood products, collected from an ineligible donor, were distributed",5/9/2013,"05/09/2013",8/28/2013,"08/28/2013"
"Biologics",65250,"Terminated","Community Blood Centers of South Florida, Inc.","Hialeah","FL","US","Voluntary: Firm Initiated","FAX","Tennessee; Florida","B-2114-13","Class III","Blood and Blood Products for Reprocessing","W036813013386; W036812634195; ",".","2","Blood products, collected from a donor in whom donor suitability was not adequately determined, were distributed.",4/17/2013,"04/17/2013",8/28/2013,"08/28/2013"
"Biologics",65250,"Terminated","Community Blood Centers of South Florida, Inc.","Hialeah","FL","US","Voluntary: Firm Initiated","FAX","Tennessee; Florida","B-2118-13","Class II","Red Blood Cells","2468490; ",".","1","Blood products, collected from a donor in whom donor suitability was not adequately determined, were distributed.",4/17/2013,"04/17/2013",8/28/2013,"08/28/2013"
"Biologics",65250,"Terminated","Community Blood Centers of South Florida, Inc.","Hialeah","FL","US","Voluntary: Firm Initiated","FAX","Tennessee; Florida","B-2116-13","Class II","Fresh Frozen Plasma","W036812449727; ",".","1","Blood products, collected from a donor in whom donor suitability was not adequately determined, were distributed.",4/17/2013,"04/17/2013",8/28/2013,"08/28/2013"
"Biologics",65250,"Terminated","Community Blood Centers of South Florida, Inc.","Hialeah","FL","US","Voluntary: Firm Initiated","FAX","Tennessee; Florida","B-2117-13","Class II","Platelets Pooled Leukocytes Reduced","W036812851617; W036812841109; ",".","2","Blood products, collected from a donor in whom donor suitability was not adequately determined, were distributed.",4/17/2013,"04/17/2013",8/28/2013,"08/28/2013"
"Biologics",65250,"Terminated","Community Blood Centers of South Florida, Inc.","Hialeah","FL","US","Voluntary: Firm Initiated","FAX","Tennessee; Florida","B-2115-13","Class II","Red Blood Cells Leukocytes Reduced","W036813013386; W036812634195; W036812449727; ",".","3","Blood products, collected from a donor in whom donor suitability was not adequately determined, were distributed.",4/17/2013,"04/17/2013",8/28/2013,"08/28/2013"
"Biologics",65251,"Terminated","Community Blood Centers of South Florida, Inc.","Lake Worth","FL","US","Voluntary: Firm Initiated","FAX","Switzerland; Florida","B-2119-13","Class II","Platelets Pooled Leukocytes Reduced","W036811804654; ",".","1","Blood products, collected from an ineligible donor, were distributed. ",4/12/2013,"04/12/2013",8/28/2013,"08/28/2013"
"Biologics",65251,"Terminated","Community Blood Centers of South Florida, Inc.","Lake Worth","FL","US","Voluntary: Firm Initiated","FAX","Switzerland; Florida","B-2122-13","Class II","Red Blood Cells","W036809182342; 1700651; ",".","2","Blood products, collected from an ineligible donor, were distributed. ",4/12/2013,"04/12/2013",8/28/2013,"08/28/2013"
"Biologics",65251,"Terminated","Community Blood Centers of South Florida, Inc.","Lake Worth","FL","US","Voluntary: Firm Initiated","FAX","Switzerland; Florida","B-2121-13","Class III","Blood and Blood Products for Reprocessing","W036809182342; ",".","1","Blood products, collected from an ineligible donor, were distributed. ",4/12/2013,"04/12/2013",8/28/2013,"08/28/2013"
"Biologics",65251,"Terminated","Community Blood Centers of South Florida, Inc.","Lake Worth","FL","US","Voluntary: Firm Initiated","FAX","Switzerland; Florida","B-2123-13","Class II","Fresh Frozen Plasma","W036811057950; 1700651; ",".","2","Blood products, collected from an ineligible donor, were distributed. ",4/12/2013,"04/12/2013",8/28/2013,"08/28/2013"
"Biologics",65251,"Terminated","Community Blood Centers of South Florida, Inc.","Lake Worth","FL","US","Voluntary: Firm Initiated","FAX","Switzerland; Florida","B-2124-13","Class II","Platelets","1700651; ",".","1","Blood products, collected from an ineligible donor, were distributed. ",4/12/2013,"04/12/2013",8/28/2013,"08/28/2013"
"Biologics",65251,"Terminated","Community Blood Centers of South Florida, Inc.","Lake Worth","FL","US","Voluntary: Firm Initiated","FAX","Switzerland; Florida","B-2120-13","Class II","Red Blood Cells Leukocytes Reduced","W036811057950; ",".","1","Blood products, collected from an ineligible donor, were distributed. ",4/12/2013,"04/12/2013",8/28/2013,"08/28/2013"
"Biologics",65252,"Terminated","OneBlood / dba CBCF","Lauderhill","FL","US","Voluntary: Firm Initiated","FAX","Florida","B-1943-13","Class II","Red Blood Cells","2182124; 1799950",".","2 units","Blood products, collected from an ineligible donor, were distributed. ",4/16/2006,"04/16/2006",7/17/2013,"07/17/2013"
"Biologics",65252,"Terminated","OneBlood / dba CBCF","Lauderhill","FL","US","Voluntary: Firm Initiated","FAX","Florida","B-1944-13","Class II","Fresh Frozen Plasma","2182124",".","1 unit","Blood products, collected from an ineligible donor, were distributed. ",4/16/2006,"04/16/2006",7/17/2013,"07/17/2013"
"Drugs",65253,"Ongoing","Clinical Specialties Compounding Pharmacy","Augusta","GA","US","Voluntary: Firm Initiated","Telephone","FL, GA, IN, LA and SC.","D-918-2013","Class II","Avastin, (0.05 ml, 1.25 mg/0.05ml), single unit dose syringes, Clinical Specialties Compounding Pharmacy, Augusta, GA ","Lot #CABDAHAC:39, Exp. Date: 5/8/2013; Lot #CABDAGAC:58, Exp. Date: 4/13/2013; Lot #CABDAHAC:77, Exp. Date: 4/8/2013; Lot #CABDBIAC:86, Exp. Date: 4/19/2013; Lot #CABDCFAC:29, Exp. Date: 4/26/2013; Lot #CABDAEAD:26, Exp. Date: 5/3/2013; Lot #CABDAEAC:47, Exp. Date: 5/5/2013; Lot #CABDAEAC:58, Exp. Date: 5/5/2013; Lot #CABDAFAC:46, Exp. Date: 5/6/2013; Lot #CABDAIAC:46, Exp. Date: 5/9/2013; Lot #CABDBCAC:94, Exp. Date: 5/13/2013; Lot #CABDCCAC:26, Exp. Date: 5/23/2013; Lot #CABDCFAC:81, Exp. Date: 5/26/2013; Lot #CABDABAD:05, Exp. Date: 5/30/2013; Lot #CABDAFAC:47, Exp. Date: 5/6/2013; Lot #CABDAGAC:43, Exp. Date: 5/7/2013; Lot #CABDBDAC:69, Exp. Date: 5/14/2013; Lot #CABDBIAC:77, Exp. Date: 5/19/2013; Lot #CABDCHAC:19, Exp. Date: 5/28/2013; Lot #CABDAHAD:21, Exp. Date: 6/5/2013; Lot #CABDCFAC:17, Exp. Date: 5/26/2013; Lot #CABDAHAD:00, Exp. Date: 6/5/2013; Lot #CABDBCAC:47, Exp. Date: 5/13/2013; Lot #CABDCBAC:97, Exp. Date: 5/22/2013; Lot #CABDAGAC:08, Exp. Date: 5/7/2013; Lot #CABDBCAC:15, Exp. Date : 5/13/2013; Lot #CABDBDAC:17, Exp. Date: 5/14/2013; Lot #CABDCIAC:42, Exp. Date : 5/29/2013; Lot #CABDBEAC:44, Exp. Date: 5/15/2013; Lot #CABDCBAC:79, Exp. Date: 5/22/2013; Lot #CABDCIAC:00, Exp. Date : 5/29/2013; Lot #CABDAHAD:82, Exp. Date : 6/5/2013; Lot #CABDCBAC:31, Exp. Date: 5/22/2013; Lot #CABDCIAB:68, Exp. Date: 4/28/2013; Lot #CABDCJAB:59, Exp. Date: 4/29/2013; Lot #CABDDBAB:93, Exp. Date: 5/1/2013; Lot #CABCCGBC:92, Exp. Date: 2/24/2013; Lot #CABCCGBC:49, Exp. Date: 3/26/2013; Lot #CABCCIBC:39, Exp. Date: 3/23/2013; Lot #CABCDBBC:71, Exp. Date: 3/1/2013; Lot #CABDACAB:56, Exp. Date: 4/2/2013; Lot #CABDACAB:76, Exp. Date: 4/2/2013; Lot #CABDACAB:89, Exp. Date: 4/2/2013; Lot #CABDADAB:69, Exp. Date: 4/3/2013; Lot #CABDADAB:93, Exp. Date: 4/3/2013; Lot #CABDADAB:54, Exp. Date: 4/3/2013; Lot #CABDAEAB:96, Exp. Date: 4/4/2013; Lot #CABDAHAB:00, Exp. Date: 4/7/2013; Lot #CABDAHAB:59, Exp. Date: 4/7/2013; Lot #CABDAHAB:18, Exp. Date: 4/7/2013; Lot #CABDAJAB:30",,"2190 syringes","Lack of Assurance of Sterility; product linked to adverse event reports of endophthalimitis eye infections and FDA inspection findings resulted in concerns regarding quality control processes",3/11/2013,"03/11/2013",9/4/2013,"09/04/2013"
"Devices",65254,"Ongoing","Baxter Healthcare Corp.","Deerfield","IL","US","Voluntary: Firm Initiated","Letter","Nationwide Distribution.","Z-1565-2013","Class II","Baxter, MiniCap with Povidone-Iodine solution, 5C4466P, Baxter Healthcare Corporation, Deerfield, IL 30015 USA. Intended to isolate the Easy-Lock connector of the solution transfer set.","Lot Number GD893891",,"629,280 units ","leaking pouches",5/21/2013,"05/21/2013",7/3/2013,"07/03/2013"
"Devices",65255,"Ongoing","Gyrus Acmi, Incorporated","Southborough","MA","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution - USA (nationwide) and countries of: Canada and United Kingdom.","Z-1439-2013","Class II","GYRUS ACMI, MYRINGOTOMY KNIFE DISPOSABLE, SICKLE BLADE FLAT HANDLE, REF 130715, Rx only, STERILE EO, GYRUS ACMI, INC., 136 TURNPIKE ROAD, SOUTHBOROUGH, MA 01722-2104 Disposable myringotomy knife intended to perforate the tympanic membrane to allow the placement of a bent tube or to directly provide ventilation or drainage of the middle ear. ","JC477666",".","100 boxes of 6 units ","lack of sterility assurance",5/24/2013,"05/24/2013",6/12/2013,"06/12/2013"
"Food",65256,"Ongoing","HP Hood LLC","Vernon","NY","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","NY, CT, MD, PA, MO, MN, WI, IA, UT, OR, AZ, IL, FL, WI, AL, ME, OH, NE, NV, IN, and CA","F-1473-2013","Class II","1% Low Fat Cottage Cheese distributed under the following labels and sizes: (a) Fiber One brand Lowfat Cottage Cheese, 1% Milkfat Minimum, NET WT, 16 OZ (453g), UPC 041483035585, DISTRIBUTED BY HP HOOD LLC, LYNNFIELD, MA 01940; (b) Hood brand Low Fat Cottage Cheese, SMALL CURD, 1% MILKFAT, NET WT 24 OZ (680g), UPC 044100106330; HP HOOD LLC, LYNNFIELD, MA 01940; (c) Hannaford brand Lowfat Cottage Cheese, 1% milkfat, small curd, NET WT. 24 OZ (680g), UPC 041268148615, DISTRIBUTED BY; HANNAFORD BROS. CO., SCARBOROUGH, ME 04074; (d) Weis brand lowfat cottage cheese, SMALL CURD, 1% MILKFAT, NET WT 24 OZ (1 LB 8 OZ) 680g, UPC 041497096886, PACKED FOR WEIS MARKETS, INC., SUNBURY, PA 17801; (e) Big Y brand Small Curd Low Fat Cottage Cheese, 1% MILKFAT, NET WT 24 OZ (1 LB 8Z) 680g, UPC 018894300977, DISTRIBUTED BY: BIG Y FOODS, INC., SPRINGFIELD, MA 01104; (f) Market Basket brand Lowfat Cottage Cheese, Small Curd, 1% Milkfat, NET Wt. 24 OZ. (680g), UPC 049705682968, PACKED EXCLUSIVELY FOR DEMOULAS SUPERMARKETS INC., TEWKSBURY, MA 01876; (g) Shurfine brand LOWFAT Cottage Cheese, 1% MILKFAT, NET WT 24 OZ (1 LB 8 OZ) 680g, UPC 015400834605, Proudly Distributed By: Western Family Foods, Inc., Portland, OR 97208; (h) Friendly Farms brand Small Curd Cottage Cheese, Low Fat, 1% MILKFAT, NET WT 24 OZ (1 LB 8 OZ) 680 g, UPC 041498154905. ","Date Code JUN 14 13",".",,"Possible presence of metal fragments.",5/22/2013,"05/22/2013",6/12/2013,"06/12/2013"
"Food",65256,"Ongoing","HP Hood LLC","Vernon","NY","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","NY, CT, MD, PA, MO, MN, WI, IA, UT, OR, AZ, IL, FL, WI, AL, ME, OH, NE, NV, IN, and CA","F-1471-2013","Class II","Cottage Cheese with Chive distributed under the following labels and sizes: (a) Hood brand Cottage Cheese with Chive, SMALL CURD 4% MILKFAT, NET WT. 16 OZ. (453g), UPC 044100102264, HP HOOD LLC, LYNNFIELD, MA 01940; (b) Hood brand Cottage Cheese with Chive, SMALL CURD 4% MILKFAT, NET WT. 24 OZ (680 g), UPC 044100104916, HP HOOD LLC, LYNNFIELD, MA 01940; (c) Big Y brand Small Curd Cottage Cheese With Chives, 4% MILKFAT, NET WT 16 OZ (1 LB) 453g, UPC 018894300960, DISTRIBUTED BY BIG Y FOODS, INC., SPRINGFIELD, MA 01104.","Date Code JUN 14 13",".",,"Possible presence of metal fragments.",5/22/2013,"05/22/2013",6/12/2013,"06/12/2013"
"Food",65256,"Ongoing","HP Hood LLC","Vernon","NY","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","NY, CT, MD, PA, MO, MN, WI, IA, UT, OR, AZ, IL, FL, WI, AL, ME, OH, NE, NV, IN, and CA","F-1472-2013","Class II","4% Cottage Cheese distributed under the following labels and sizes: (a) Hannaford brand Cottage Cheese, 4% milkfat, small curd, NET WT. 24 OZ (680g), UPC 041268114504, DISTRIBUTED BY: HANNAFORD BROS. CO., SCARBOROUGH, ME 04074; (b) Weis brand SMALL CURD original cottage cheese, 4% MILKFAT MIN., NET WT 24 OZ (1 LB 8 OZ) 680g, UPC 041497096855, PACKED FOR WEIS MARKETS, INC., SUNBURY, PA 17801; (c) Big Y brand Small Curd Cottage Cheese, 4% MILK FAT MIN, NET WT 24 OZ (680g), UPC 018894300984, DISTRIBUTED BY BIG Y FOODS, INC., SPRINGFIELD, MA 01104; (d) Shurfine brand SMALL CURD Cottage Cheese, 4% MILKFAT, NET WT 24 OZ (1LB 8 OZ) 680g, UPC 015400832984, Distributed By: Western Family Foods, Inc. Portland, OR 97208; (e) Friendly Farms brand Small Curd Cottage Cheese, 4% MILKFAT MINIMUM, NET WT 24 OZ (1 LB 8 OZ) 680g, UPC 041498192174, Distributed by ALDI, Inc., Batavia, IL 60510.","Date Code JUN 14 13",".",,"Possible presence of metal fragments.",5/22/2013,"05/22/2013",6/12/2013,"06/12/2013"
"Devices",65257,"Ongoing","Hill-Rom, Inc.","Batesville","IN","US","Voluntary: Firm Initiated","Letter","Worldwide distribution: US (Nationwide) and countries of: Argentina , Bahamas, Bahrain, Bolivia, Brazil, Canada, Chile, China, Colombia, Costa Rica, Ecuador, Egypt, Ethiopia, France, Ghana, Guam, Hong Kong, India, Indonesia, Japan, Jordan, Kuwait, Lebanon, Libya, Malaysia, Mexico, N. Mariana Islands, Pakistan, panama, Paraguay, Puerto Rico, Qatar, Saudi Arabia, Singapore, South Africa, South Korea, Taiwan, Thailand, United Arab Emirates, United States, US Virgin Islands, Venezuela and Vietnam.","Z-1466-2013","Class II","Hill-Rom 1000 Bed, Product No. P1160. The Hill-Rom 1000 Bed is intended for low to moderate acuity patient in the medical surgical area of the hospital.","Product number (P1160) with Serial Numbers J143AP0937 thru O080AP5661.",".","8,737 devices","Complaints have been reported for brakes disengaging when the bed is subjected to a hard jolt or force to the frame. ",4/15/2013,"04/15/2013",6/12/2013,"06/12/2013"
"Devices",65258,"Ongoing","Zimmer Surgical Inc","Dover","OH","US","Voluntary: Firm Initiated","Telephone","Worldwide distribution: USA Nationwide including Puerto Rico; UAE, TAIWAN, SWEDEN, THAILAND, KOREA, SINGAPORE, HONG KONG CHINA, CHILE, CANADA, AUSTRALIA, JAPAN, ENGLAND, GERMANY, and EGYPT.","Z-1484-2013","Class II","Zimmer Air Dermatome II, REF 00-8851-001-00 handpiece Rx, non-sterile grafting instruments intended to provide variable graft thickness and width capabilities","Serial Number 500191 , 500192,500193, 500194,500196,500197,500198,500199, 500200, 500201,500202,500203, 500204, 500205,500206, 500207,500208,500209,500210, 500211,500212, 500213,500215,500216,500217, 500219,500220, 500221,500222, 500223, 500224, 500225,500226,500227,500228,500229,500230, 500231,500232, 500233,500234,500235,500236, 500237, 500238,500239,500240,500241 , 500242, 500243,500244,500245,500246,500247,500248,500249, 500250, 500251,500252,500253,500254, 500255,500256,500257,500258,500259, 500260,500261,500262,500263,500264, 500265,500266,500267,500268,500269, 500270,500291, 500292,500293,500295,500296,500297,500298, 500299,500300,500301 , 500302,500303, 500304, 500306, 500307,500308,500309,500310, 500331 , 500332, 500334, 500335, 500336, 500337, 500338, 500339, 500340, 500341,500342, 500343, 500344, 500345, 500346, 500347, 500348,500349, 500350, 500351 , 500352, 500353, 500354,500355, 500357, 500358, 500359, 500368, 500369,500370,500371",".","126 units","This removal is in response to complaints alleging that the Zimmer Air Dermatomes and Zimmer Air Dermatome II products would either not operate or operate intermittently. Zimmer's investigation determined that the planetary gear teeth were broken. This may cause a delay or postponement of the surgery or result in a suboptimal graft retrieval with potential of requiring an additional donor site.",5/7/2013,"05/07/2013",6/12/2013,"06/12/2013"
"Devices",65258,"Ongoing","Zimmer Surgical Inc","Dover","OH","US","Voluntary: Firm Initiated","Telephone","Worldwide distribution: USA Nationwide including Puerto Rico; UAE, TAIWAN, SWEDEN, THAILAND, KOREA, SINGAPORE, HONG KONG CHINA, CHILE, CANADA, AUSTRALIA, JAPAN, ENGLAND, GERMANY, and EGYPT.","Z-1483-2013","Class II","The Zimmer Air Dermatome, REF 00- 8801- 001- 00 , Rx, non-sterile grafting instruments intended to provide variable graft thickness and width capabilities","Serial Number 100211, 100338, 100515, 100560, 100647, 100755, 101104, 101345, 101562, 101769, 101890, 101983, 102560, 103407, 103509, 103816, 104529, 104863, 105049, 105072, 105604, 106394, 106474, 106624, 107861, 108103, 108203, 108210, 108339, 108911, 109445, 109543, 110034, 110837, 111046, 111047, 111048, 111049, 111050, 111051, 111052, 111053, 111054, 111055, 111056, 111057, 111058, 111059, 111060, 111061, 111062, 111063, 111064, 111065, 111066, 111067, 111068, 111069, 111071, 111072, 111073, 111074, 111075, 111076, 111079, 111081, 111083, 111084, 111085, 111086, 111087, 111089, 111090, 111091, 111092, 111096, 111100, 111101, 111102, 111104, 111105, 111116, 111121, 111122 ",".","84 units","This removal is in response to complaints alleging that the Zimmer Air Dermatomes and Zimmer Air Dermatome II products would either not operate or operate intermittently. Zimmer's investigation determined that the planetary gear teeth were broken. This may cause a delay or postponement of the surgery or result in a suboptimal graft retrieval with potential of requiring an additional donor site.",5/7/2013,"05/07/2013",6/12/2013,"06/12/2013"
"Devices",65258,"Ongoing","Zimmer Surgical Inc","Dover","OH","US","Voluntary: Firm Initiated","Telephone","Worldwide distribution: USA Nationwide including Puerto Rico; UAE, TAIWAN, SWEDEN, THAILAND, KOREA, SINGAPORE, HONG KONG CHINA, CHILE, CANADA, AUSTRALIA, JAPAN, ENGLAND, GERMANY, and EGYPT.","Z-1485-2013","Class II","Zimmer Air Dermatome II, REF 00-8851-001-01 handpiece, w/o hose, Rx, non-sterile grafting instruments intended to provide variable graft thickness and width capabilities. ","Serial Number 500311, 500312, 500317, 500320, 500321, 500322, 500323, 500324, 500325, 500326, 500327, 500328, 500329",".","13 units","This removal is in response to complaints alleging that the Zimmer Air Dermatomes and Zimmer Air Dermatome II products would either not operate or operate intermittently. Zimmer's investigation determined that the planetary gear teeth were broken. This may cause a delay or postponement of the surgery or result in a suboptimal graft retrieval with potential of requiring an additional donor site.",5/7/2013,"05/07/2013",6/12/2013,"06/12/2013"
"Devices",65259,"Ongoing","Hill-Rom, Inc.","Batesville","IN","US","Voluntary: Firm Initiated","Letter","Worldwide distribution: USA (nationwide) and countries of: Canada, Columbia, Nigeria, Kuwait and Saudi Arabia.","Z-1794-2013","Class II","TotalCare Bed used with AccuMax Quantum VPC mattress AccuMax Quantum Complete mattress, and AccuMax Quantum Convertible mattress The TotalCare Bed System is intended to provide a patient support ideally suited to be used in health care environments. The TotalCare Bed System may be used in a variety of settings including, but not limited to, acute care, including critical care, step down/progressive care, medical/surgical, high acuity sub-acute care, post anesthesia care unit (PACU), and sections of the emergency department (ED). The TotalCare Bed System is capable of being used with a broad patient population as determined appropriate by the caregiver or institution.","Bed model numbers: PAU001010784, PAU005010784, P1900, PAK169N10184, PAK169N10384, PA8171210184, PA8175210184, PA8175210384, PA8171210384, PA8171310384, and PA8173210384. The AccuMax Quantum VPC, Complete and Convertible mattresses are not serialized, but were distributed between September 2005 and April 2013",,"4,121 Units","Hill-Rom is initiating this recall due to a potential issue with TotalCare Beds equipped with AccuMax Quantum'' mattresses. If the bed is put into the chair egress position, the magnets on the mattress may not hold the bottom of the mattress flat to the bed frame. If this happens, the foot section of the mattress will extend away from the bed at about a 30 angle (as shown in the photo). A patient attempting to get back into the bed may assume that the mattress is against the bed and attempt to sit, but may miss the seat and sit on the foot section instead. This can result in the patient sliding down to the floor, with possible injury. If the patient falls, the result may be major critical muscular/skeletal injury.",5/30/2013,"05/30/2013",7/31/2013,"07/31/2013"
"Food",65260,"Ongoing","C H S Inc","Hutchinson","KS","US","Voluntary: Firm Initiated","E-Mail","Distribution was made to IA and CA. No international or military distribution was made.","F-1801-2013","Class II","IMAGIC Vegetarian Burger Mix, VB 100, textured vegetable protein, contains soy and wheat, packaged in 25-lb/bulk cartons. CHS Inc., Hutchinson, KS.","Lot: 12173, 12305 and 13065.",,"173/25-lb cartons","The product contains Soy Protein Isolate which may be contaminated with Salmonella.",5/21/2013,"05/21/2013",8/21/2013,"08/21/2013"
"Food",65261,"Ongoing","Norpac Foods, Inc.","Stayton","OR","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Products distributed in California, Missouri, and Oregon, and Wisconsin.","F-1550-2013","Class II","FLAV-R-PAC IQF Chopped Spinach, packaged in a 32 oz. bag, NORPAC Catalog #30238-01. The UPC is 0 48800 30238 2 The product is labeled in parts: ''***FLAV R PAC***Classic Vegetables***Chopped Spinach***INGREDIENTS: Spinach***NET WT 32 OZ (2 LB)***PRODUCT OF USA***Keep frozen until ready to use***Distributed by Norpac Foods Inc 4350 S.W. Galewood St. Lake Oswego, OR 97035-2499***www.norpac.com***''.","BEST BY FEB 2015/ 5F3 1248 19 HH:MM. The code is interpreted as: 5F3 1248 19 HH:MM- Packed into Poly Bags on February 12, 2013 7:00am to 9:30am at NORPAC Foods Inc. Repack Plant #8 2210 Madrona Ave S.E. Salem. Oregon 97302-1112. 5 = Pkr; F = February: 3 = 2013; 12 = DD; 4 = Period; 8 = Plant #; 19 = Line #: & HH:MM = Time",,"411 cases/6 packages/32 oz.","IQF frozen chopped Spinach is recalled due to detection of elevated level of Cadmium.",5/22/2013,"05/22/2013",7/3/2013,"07/03/2013"
"Food",65262,"Ongoing","Mother Earth International LLC","Ames","IA","US","Voluntary: Firm Initiated","E-Mail","Distribution was nationwide through internet sales. No foriegn or military distribution was made.","F-1590-2013","Class II","Mother Earth Products, Veggie Burger, Textured Vegetable Protein, packaged in 2-cup mylar bags, 1-quart mylar bags, 1-quart plastic jar, 1-gallon mylar bags, 5-lb mylar bags, 15-lb bulk bag, 25-lb bulk box and TVP Variety Sample Pack.","They use a manufacture date code. 712 means July 2012. Their customer letter states product manufactured July 1, 2012 to present. ",".","210","The product was manufactured with a Soy Protein Isolate manufactured by CHS, Inc and may be contaminated with Salmonella.",5/23/2013,"05/23/2013",7/17/2013,"07/17/2013"
"Devices",65263,"Ongoing","Prism Medical Services USA","Maryland Heights","MO","US","Voluntary: Firm Initiated","E-Mail","Worldwide distribution: USA (nationwide) including states of: CA, IL, OH, and TX. and country of: Canada.","Z-1553-2013","Class II","BC Hammock Mesh Sling (Large), product number, 537030. Product Usage: The fabric sling is used for the transfer of a patient, for example from a bed to a wheelchair. ","Lot: PHM000884, PHM000881, PHM000882, PHM000883 and PHM000885.",,"5 slings","The product does not meet the firm's size standards, the product was produced in the incorrect size.",5/23/2013,"05/23/2013",6/26/2013,"06/26/2013"
"Devices",65263,"Ongoing","Prism Medical Services USA","Maryland Heights","MO","US","Voluntary: Firm Initiated","E-Mail","Worldwide distribution: USA (nationwide) including states of: CA, IL, OH, and TX. and country of: Canada.","Z-1555-2013","Class II","BC Hammock Mesh Sling (Junior), product number, 537005. Product Usage: The fabric sling is used for the transfer of a patient, for example from a bed to a wheelchair. ","Lot: PHM000524.",,"1 sling","The product does not meet the firm's size standards, the product was produced in the incorrect size.",5/23/2013,"05/23/2013",6/26/2013,"06/26/2013"
"Devices",65263,"Ongoing","Prism Medical Services USA","Maryland Heights","MO","US","Voluntary: Firm Initiated","E-Mail","Worldwide distribution: USA (nationwide) including states of: CA, IL, OH, and TX. and country of: Canada.","Z-1552-2013","Class II","BC Hammock Mesh Sling (Medium), product number, 537005. Product Usage: Usage: The fabric sling is used for the transfer of a patient, for example from a bed to a wheelchair. ","Lot: PHM000444, PHM000445, PHM000446, PHM000447, PHM000634, PHM000635, PHM000636, PHM000637, PHM000294 and PHM000638.",,"10 slings","The product does not meet the firm's size standards, the product was produced in the incorrect size.",5/23/2013,"05/23/2013",6/26/2013,"06/26/2013"
"Devices",65263,"Ongoing","Prism Medical Services USA","Maryland Heights","MO","US","Voluntary: Firm Initiated","E-Mail","Worldwide distribution: USA (nationwide) including states of: CA, IL, OH, and TX. and country of: Canada.","Z-1554-2013","Class II","BC Hammock Mesh Sling (Small), product number, 537010. Product Usage: The fabric sling is used for the transfer of a patient, for example from a bed to a wheelchair. ","Lot: PHM000053, PHM000648, PHM000732, PHM000733 and PHM000734.",,"5 slings","The product does not meet the firm's size standards, the product was produced in the incorrect size.",5/23/2013,"05/23/2013",6/26/2013,"06/26/2013"
"Biologics",65265,"Terminated","Blood Systems Inc ","Scottsdale","AZ","US","Voluntary: Firm Initiated","Telephone","IL, AZ","B-2147-13","Class III","Red Blood Cells","W0410130357788; W041013044809A; W041013044904C; W0410130449068; W0410130499779; W041013049992B",".","6 units","Blood products, collected using an expired blood collection set, were distributed.",4/5/2013,"04/05/2013",8/28/2013,"08/28/2013"
"Biologics",65266,"Terminated","DCI Biologicals Temple Terrace, LLC","Temple Terrace","FL","US","Voluntary: Firm Initiated","FAX","CA","B-2146-13","Class II","Source Plasma","TT0155293; TT0155522",".","2 units","Blood products, collected from a donor who received a tattoo within 12 months of donation, were distributed.",4/15/2013,"04/15/2013",8/28/2013,"08/28/2013"
"Biologics",65267,"Terminated","Community Blood Center of Carolinas","Charlotte","NC","US","Voluntary: Firm Initiated","Telephone","NC","B-2145-13","Class II","Fresh Frozen Plasma","W227012072941",".","1 unit","Blood products, collected from a donor whose suitability to donate was not adequately determined, were distributed.",4/8/2013,"04/08/2013",8/28/2013,"08/28/2013"
"Biologics",65267,"Terminated","Community Blood Center of Carolinas","Charlotte","NC","US","Voluntary: Firm Initiated","Telephone","NC","B-2144-13","Class II","Red Blood Cells Leukocytes Reduced Irradiated","W227012072941",".","1 unit","Blood products, collected from a donor whose suitability to donate was not adequately determined, were distributed.",4/8/2013,"04/08/2013",8/28/2013,"08/28/2013"
"Biologics",65268,"Terminated","Plasma Biological Services","Owensboro","KY","US","Voluntary: Firm Initiated","E-Mail","TN","B-2143-13","Class II","Source Plasma","BQ128259",".","1 unit","Blood product, collected from a donor who was previously deferred, was distributed.",4/2/2013,"04/02/2013",8/28/2013,"08/28/2013"
"Drugs",65269,"Completed","Physicians Total Care, Inc.","Tulsa","OK","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Nationwide","D-547-2013","Class II","Metronidazole Tablets, USP, 500 mg, packaged in a) 10-count tablets per bottle (NDC 54868-0158-3); b) 14-count tablets per bottle (NDC 54868-0158-1); c) 20-count tablets per bottle (NDC 54868-0158-5); d) 21-count tablets per bottle (NDC 54868-0158-0); e) 30-count tablets per bottle (NDC 54868-0158-8), Rx only, Mfg. By: Pliva Krakow Pharma. Comp., Krakow, Poland; Repacked & distributed by: Physicians Total Care, Inc., Tulsa, OK 74146.","Entry Format for Lots is: PTC Lot #; Exp Date; Distributor Bulk Lot #.PTC Lot #614S; Exp 05/31/2013; Teva Lot #14108110A. PTC Lot #6HFC; Exp 06/30/2013; Teva Lot #14127710A. PTC Lot #615S; Exp 08/31/2013; Teva Lot #14180910A. PTC Lot #4614; Exp 04/30/2011; Barr Lot #306670. PTC Lot #46TQ; Exp 04/30/2011; Barr Lot #306670. PTC Lot #48GN; Exp 05/31/2011; Barr Lot #307039. PTC Lot #4A36; Exp 05/31/2011; Barr Lot #307127. PTC Lot#4AA9; Exp 05/31/2011; Barr Lot #307127. PTC Lot #4ASM; Exp 05/31/2011; Barr Lot #307128. PTC Lot #4AWE; Exp 05/31/2011; Barr Lot# 307128. PTC Lot #4AWG; Exp 05/31/2011; Barr Lot#307128. PTC Lot#4AZR; Exp 05/31/2011; Barr Lot #307128. PTC Lot #4B72; Exp 05/31/2011; Barr Lot #307128. PTC Lot #4C50; Exp 06/30/2011; Barr Lot #307360. PTC Lot# 4BOZ; Exp 06/30/2011; Barr Lot #307537. PTC Lot #4BPO; Exp 06/30/2011; Barr Lot #307537. PTC Lot #4E2R; Exp 07/31/2011; Barr Lot #307901. PTC Lot #4D68; Exp 08/31/2011; Barr Lot #307953. PTC Lot #4ETP; Exp 08/31/2011; Barr Lot #307954. PTC Lot #4F8Y; Exp 08/31/2011; Barr Lot #307954. PTC Lot #4F8Z; Exp 08/31/2011; Barr Lot #307954. PTC Lot #4FCP; Exp 08/31/2011; Barr Lot #307954. PTC Lot #4GCM; Exp 08/31/2011; Barr Lot #307954. PTC Lot #4GY4; Exp 09/30/2011; Barr Lot #308266. PTC Lot #4HR8; Exp 09/30/2011; Barr Lot #308266. PTC Lot #4HZ4; Exp 09/30/2011; Barr Lot #308266. PTC Lot #4IE9; Exp 09/30/2011; Barr Lot #308266. PTC Lot #4J14; Exp 09/30/2011; Barr Lot #308266. PTC Lot #4JBR; Exp 09/30/2011; Barr Lot #308266. PTC Lot #4JN3; Exp 09/30/2011; Barr Lot #308266. PTC Lot #4JQ0; Exp 09/30/2011; Barr Lot #308266. PTC Lot #4KFL; Exp 09/30/2011; Barr Lot #308266. PTC Lot #4KT7; Exp 08/31/2011; Barr Lot #308403. PTC Lot #4L2L; Exp 08/31/2011; Barr Lot #308403. PTC Lot #4LWK; Exp 08/31/2011; Barr Lot #308403. PTC Lot #4MAL; Exp 08/31/2011; Barr Lot #308403. PTC Lot #4MEY; Exp 08/31/2011; Barr Lot #308403. PTC Lot #4MX9; Exp 08/31/2011; Barr Lot #308403. PTC Lot #4NBB; Exp 08/31/2011; Barr Lot #308403. PTC Lot #4NBZ; Exp 08/31/2011; Barr Lot #308403. PTC Lot #",".","25230 tablets: a) 190 bottles, b) 743 bottles, c) 293 bottles, d) 8 bottles, e) 230 bottles","Failed Tablet/Capsule Specifications: Some tablets had the potential to not conform to weight specifications.",4/6/2011,"04/06/2011",6/12/2013,"06/12/2013"
"Veterinary",65270,"Ongoing","Sogeval Laboratories Inc","Oldsmar","FL","US","Voluntary: Firm Initiated","Letter","Product was distributed to 8 domestic distributors, and 1 foreign distributor in Canada.","V-209-2013","Class III","''***SOGevaL***KETOSEB FLUSH+PS Chlorhexidine 2%, Ketoconazole 0.2%, Phytosphingosine 0.02% Topical Antiseptic Formulation with Astringent, Cleansing and Drying Properties.***16 FL OZ***Contact Sogeval Laboratories, Inc., Oldsmar, FL, 1-800-877-0177***''.","All lot numbers for 16 oz bottles distributed prior to 04/17/2013. Possible affected lots: 110167 exp 08/2013 100237B exp 01/2014 120879A exp 09/2014 130052C exp 02/2015 110912B exp 10/2013 120448 exp 05/2014 120879C exp 09/2014 110912D exp 12/2013 120605B 06/2014 122000B exp 12/2014",,,"Recall due to an error on the label in which the concentration of Chlorhexidine is reported as 2%, however the actual concentration is 0.2%",4/17/2013,"04/17/2013",6/26/2013,"06/26/2013"
"Veterinary",65271,"Ongoing","Sogeval Laboratories Inc","Oldsmar","FL","US","Voluntary: Firm Initiated","Letter","Product was distributed to 8 domestic wholesalers/distributors and 1 foreign distributor.","V-210-2013","Class II"," SOGEVAL VETRICALM Soft Chews for Dogs Contact Sogeval Laboratories, Inc., Oldsmar, FL","Lot #008871 (60 count), expiration date 11/2013 Lot #008881 (120 count), expiration date 11/2013",,"3398","Product's recent testing microbial analysis revealed results exceeding that of the upper limit of normal bacterial specifications.",5/1/2013,"05/01/2013",7/3/2013,"07/03/2013"
"Food",65272,"Ongoing","Florida Nutri Labs, LLC","Lakeland","FL","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Product was distributed to 1 distributor, Kirland Science Labs located in Seattle, WA.","F1583-2013","Class II","''***DIETARY SUPPLEMENT 4HB STACK Bedtime***52 CAPLETS***MANUFACTURED EXCLUSIVELY FOR: Kirkland Science Labs 935 Jackson St #91810 Seattle, WA 98104-2818***''.","Lot #12-194, expiration date 12/2014 UPC #0 13964 66251 1",".","2526 bottles","Customer reported that a product user complained that the caplets were not coated, making them difficult to swallow.",5/22/2013,"05/22/2013",7/10/2013,"07/10/2013"
"Food",65272,"Ongoing","Florida Nutri Labs, LLC","Lakeland","FL","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Product was distributed to 1 distributor, Kirland Science Labs located in Seattle, WA.","F1582-2013","Class II","''***DIETARY SUPPLEMENT 4HB STACK Mealtime***78 CAPLETS***MANUFACTURED EXCLUSIVELY FOR: Kirkland Science Labs 935 Jackson St #91810 Seattle, WA 98104-2818***''.","Lot #12-195, expiration date 12/2014 UPC #0 13964 66250 4",".","1982 bottles","Customer reported that a product user complained that the caplets were not coated, making them difficult to swallow.",5/22/2013,"05/22/2013",7/10/2013,"07/10/2013"
"Drugs",65275,"Ongoing","Pharmacia & Upjohn LLC","Kalamazoo","MI","US","Voluntary: Firm Initiated","Letter","Nationwide","D-609-2013","Class II","Cleocin Phosphate (clindamycin Injection), USP, a) 600 mg/4mL (150 mg/mL) ADD-Vantage Vial, b) 900 mg/6mL (150 mg/mL) ADD-Vantage Vial, Rx Only, For Intravenous Use Only, Use Only with the ADD-Vantage diluent container, Distributed by Pharmacia & Upjohn Co, Division of Pfizer Inc, NY, NY 10017, NDC a) 0009-3124-03 and b) 0009-3447-03","Lots: a) G34908, Exp 06/14; G53479, Exp 09/14; G63442, G58347, Exp 10/14; G80133, Exp 12/14; and b) G34910, Exp 06/14; G36879, G41005, Exp 07/14; G53478, Exp 09/14; G63444, Exp 10/14; G76317, Exp 11/14. ",,"898,900 Vials ","Presence of Particulate Matter: Firm is recalling a small number of vials with very small reflective flakes consistent with delamination of the glass vial.",6/4/2013,"06/04/2013",6/26/2013,"06/26/2013"
"Biologics",65276,"Terminated","Community Blood Centers of South Florida, Inc.","Hialeah","FL","US","Voluntary: Firm Initiated","Telephone","Switzerland, FL, NY","B-2141-13","Class III","Blood and Blood Products for Reprocessing","W036809257757; W036809346298; W036810134483",".","3 units","Blood products, collected from a donor in which donor suitability was not adequately determined, were distributed.",4/26/2013,"04/26/2013",8/28/2013,"08/28/2013"
"Biologics",65276,"Terminated","Community Blood Centers of South Florida, Inc.","Hialeah","FL","US","Voluntary: Firm Initiated","Telephone","Switzerland, FL, NY","B-2137-13","Class II","Cryoprecipitated AHF","2236855; W036809257757 ",".","2 units","Blood products, collected from a donor in which donor suitability was not adequately determined, were distributed.",4/26/2013,"04/26/2013",8/28/2013,"08/28/2013"
"Biologics",65276,"Terminated","Community Blood Centers of South Florida, Inc.","Hialeah","FL","US","Voluntary: Firm Initiated","Telephone","Switzerland, FL, NY","B-2135-13","Class II","Platelets","2236855",".","1 unit","Blood products, collected from a donor in which donor suitability was not adequately determined, were distributed.",4/26/2013,"04/26/2013",8/28/2013,"08/28/2013"
"Biologics",65276,"Terminated","Community Blood Centers of South Florida, Inc.","Hialeah","FL","US","Voluntary: Firm Initiated","Telephone","Switzerland, FL, NY","B-2142-13","Class II","Fresh Frozen Plasma","2030388; 2326541; W036810271097",".","3 units","Blood products, collected from a donor in which donor suitability was not adequately determined, were distributed.",4/26/2013,"04/26/2013",8/28/2013,"08/28/2013"
"Biologics",65276,"Terminated","Community Blood Centers of South Florida, Inc.","Hialeah","FL","US","Voluntary: Firm Initiated","Telephone","Switzerland, FL, NY","B-2136-13","Class II","Platelets Pooled Leukocytes Reduced Irradiated","W036809820065",".","1 unit","Blood products, collected from a donor in which donor suitability was not adequately determined, were distributed.",4/26/2013,"04/26/2013",8/28/2013,"08/28/2013"
"Biologics",65276,"Terminated","Community Blood Centers of South Florida, Inc.","Hialeah","FL","US","Voluntary: Firm Initiated","Telephone","Switzerland, FL, NY","B-2134-13","Class II","Platelets Irradiated","2030388",".","1 unit","Blood products, collected from a donor in which donor suitability was not adequately determined, were distributed.",4/26/2013,"04/26/2013",8/28/2013,"08/28/2013"
"Biologics",65276,"Terminated","Community Blood Centers of South Florida, Inc.","Hialeah","FL","US","Voluntary: Firm Initiated","Telephone","Switzerland, FL, NY","B-2139-13","Class II","Platelets Pooled Leukocytes Reduced","W036810808509",".","1 unit","Blood products, collected from a donor in which donor suitability was not adequately determined, were distributed.",4/26/2013,"04/26/2013",8/28/2013,"08/28/2013"
"Biologics",65276,"Terminated","Community Blood Centers of South Florida, Inc.","Hialeah","FL","US","Voluntary: Firm Initiated","Telephone","Switzerland, FL, NY","B-2138-13","Class II","Red Blood Cells Leukocytes Reduced","W036809257757",".","1 unit","Blood products, collected from a donor in which donor suitability was not adequately determined, were distributed.",4/26/2013,"04/26/2013",8/28/2013,"08/28/2013"
"Biologics",65276,"Terminated","Community Blood Centers of South Florida, Inc.","Hialeah","FL","US","Voluntary: Firm Initiated","Telephone","Switzerland, FL, NY","B-2140-13","Class II","Red Blood Cells","2030388; 2236855; 2326541; W036809346298; W036810169486; W036810134483",".","6 units","Blood products, collected from a donor in which donor suitability was not adequately determined, were distributed.",4/26/2013,"04/26/2013",8/28/2013,"08/28/2013"
"Biologics",65277,"Terminated","Community Blood Centers of South Florida, Inc.","Lake Worth","FL","US","Voluntary: Firm Initiated","Telephone","Florida","B-1953-13","Class II","Platelets Pooled Leukocytes Reduced","W036812852142",".","1 unit","Blood products, collected from an ineligible donor, was distributed. ",4/26/2013,"04/26/2013",7/17/2013,"07/17/2013"
"Biologics",65277,"Terminated","Community Blood Centers of South Florida, Inc.","Lake Worth","FL","US","Voluntary: Firm Initiated","Telephone","Florida","B-1954-13","Class III","Blood and Blood Products for Reprocessing","W036812642595",".","1 unit","Blood products, collected from an ineligible donor, was distributed. ",4/26/2013,"04/26/2013",7/17/2013,"07/17/2013"
"Biologics",65277,"Terminated","Community Blood Centers of South Florida, Inc.","Lake Worth","FL","US","Voluntary: Firm Initiated","Telephone","Florida","B-1952-13","Class II","Cryoprecipitated AHF, Pooled","W036813801696",".","1 unit","Blood products, collected from an ineligible donor, was distributed. ",4/26/2013,"04/26/2013",7/17/2013,"07/17/2013"
"Biologics",65277,"Terminated","Community Blood Centers of South Florida, Inc.","Lake Worth","FL","US","Voluntary: Firm Initiated","Telephone","Florida","B-1956-13","Class II","Fresh Frozen Plasma","1484265",".","1 unit","Blood products, collected from an ineligible donor, was distributed. ",4/26/2013,"04/26/2013",7/17/2013,"07/17/2013"
"Biologics",65277,"Terminated","Community Blood Centers of South Florida, Inc.","Lake Worth","FL","US","Voluntary: Firm Initiated","Telephone","Florida","B-1955-13","Class II","Cryoprecipitated AHF","1741752",".","1 unit","Blood products, collected from an ineligible donor, was distributed. ",4/26/2013,"04/26/2013",7/17/2013,"07/17/2013"
"Biologics",65277,"Terminated","Community Blood Centers of South Florida, Inc.","Lake Worth","FL","US","Voluntary: Firm Initiated","Telephone","Florida","B-1951-13","Class II","Red Blood Cells","1741752; W036813022451; W036812642595; 1484265; ",".","4 units","Blood products, collected from an ineligible donor, was distributed. ",4/26/2013,"04/26/2013",7/17/2013,"07/17/2013"
"Biologics",65278,"Terminated","Community Blood Centers of South Florida, Inc.","Hialeah","FL","US","Voluntary: Firm Initiated","Telephone","Tennessee; Switzerland; Florida; California","B-1947-13","Class II","Red Blood Cells Leukocytes Reduced","W036810100975; W036812373201",".","2 units","Blood products, collected from an ineligible donor, were distributed.",4/29/2013,"04/29/2013",8/28/2013,"08/28/2013"
"Biologics",65278,"Terminated","Community Blood Centers of South Florida, Inc.","Hialeah","FL","US","Voluntary: Firm Initiated","Telephone","Tennessee; Switzerland; Florida; California","B-1950-13","Class III","Blood and Blood Products for Reprocessing","W036811019911; W036811164080; W036812373201",".","3 units","Blood products, collected from an ineligible donor, were distributed.",4/29/2013,"04/29/2013",8/28/2013,"08/28/2013"
"Biologics",65278,"Terminated","Community Blood Centers of South Florida, Inc.","Hialeah","FL","US","Voluntary: Firm Initiated","Telephone","Tennessee; Switzerland; Florida; California","B-1946-13","Class II","Fresh Frozen Plasma","W036810100975; W036812477893; W036812632589",".","3 units","Blood products, collected from an ineligible donor, were distributed.",4/29/2013,"04/29/2013",8/28/2013,"08/28/2013"
"Biologics",65278,"Terminated","Community Blood Centers of South Florida, Inc.","Hialeah","FL","US","Voluntary: Firm Initiated","Telephone","Tennessee; Switzerland; Florida; California","B-1949-13","Class II","Platelets Pooled Leukocytes Reduced Irradiated","W036811804717; W036811808529; W036811826757",".","3 units","Blood products, collected from an ineligible donor, were distributed.",4/29/2013,"04/29/2013",8/28/2013,"08/28/2013"
"Biologics",65278,"Terminated","Community Blood Centers of South Florida, Inc.","Hialeah","FL","US","Voluntary: Firm Initiated","Telephone","Tennessee; Switzerland; Florida; California","B-1948-13","Class II","Red Blood Cells","W036811019911; W036812477893; W036812632589",".","3 units","Blood products, collected from an ineligible donor, were distributed.",4/29/2013,"04/29/2013",8/28/2013,"08/28/2013"
"Biologics",65278,"Terminated","Community Blood Centers of South Florida, Inc.","Hialeah","FL","US","Voluntary: Firm Initiated","Telephone","Tennessee; Switzerland; Florida; California","B-1945-13","Class II","Platelets Pooled Leukocytes Reduced","W036810818581; W036812840236; W036812850369",".","3 units","Blood products, collected from an ineligible donor, were distributed.",4/29/2013,"04/29/2013",8/28/2013,"08/28/2013"
"Biologics",65279,"Terminated","Northern California Community Blood Bank","Eureka","CA","US","Voluntary: Firm Initiated","FAX","CA","B-2133-13","Class II","Platelets Pheresis Leukocytes Reduced","W149513934295- part 1; W149513934295-part 2; W149513934326- part 1; W149513934326- part 2; W149513934326- part 3 ",".","5 units","Blood products, which did not meet the acceptable product specifications, were distributed.",4/9/2013,"04/09/2013",8/28/2013,"08/28/2013"
"Biologics",65280,"Terminated","DCI Donor Services dba Sierra Donor Services","Sacramento","CA","US","Voluntary: Firm Initiated","Telephone","Tennessee","B-2025-13","Class II","Cornea","SDS130600OSCN; SDS130600ODCN",".","2 units","Corneas, recovered from a donor whose donor eligibility determination failed to ensure that the donor was free from risk factors for, and clinical evidence of infection due to relevant communicable disease agents and diseases, were distributed. ",5/20/2013,"05/20/2013",8/14/2013,"08/14/2013"
"Biologics",65282,"Terminated","Alba Bioscience Limited","Edinburgh",,"GB","Voluntary: Firm Initiated","Telephone","Multiple U.S. States","B-2024-13","Class III","Reagent Red Blood Cells","V133096",,"1 unit","Antibody Screening Cells, misbranded with incorrect Antigen Profile, were distributed. ",4/18/2013,"04/18/2013",8/7/2013,"08/07/2013"
"Devices",65283,"Ongoing","Dental EZ Stardental Division","Lancaster","PA","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution-USA (nationwide) including the states of CA, FL, IA, IN, NJ, NV, NY, PA, TN, TX, and WI, and the country of Japan.","Z-1522-2013","Class II","StarDental Classique(TM) Diamond Dental Bur. Used for specific applications in dental procedures.","Item 200169, lot numbers 2140459 and 2177284; Item 200174, lot numbers 2151776 and 2158861; Item 200276, lot number 2149190; Item 200288, lot number 2143968; Item 200329, lot number 2139572; Item 200339, lot number 2159105; Item 200354, lot number 2149191; Item 200394, lot number 2164110; Item 200402, lot numbers 2143162 and 2156621; Item 200415, lot number 2139573; Item 200418, lot numbers 2153439, 2163438, 2166502, 2171448, 2173003, and 2175575; Item 200433, lot numbers 2153440 and 2171670; Item 200448, lot numbers 2139574, 2157306, and 2167344; Item 200468, lot number 2151894; Item 200473, lot numbers 2146257, 2156268, and 2166207; Item 200483, lot numbers 2141173, 2151723, and 2161240; Item 200496, lot numbers 2144739, 2151899, 2157307 and 2166208.",".","3,560","Recall was initiated because a manufacturing issue was found that prevented the diamond coating from adhering properly to the shank of the diamond bur for these lots.",5/28/2013,"05/28/2013",6/19/2013,"06/19/2013"
"Drugs",65284,"Ongoing","Indelicare LLC","Newbury Park","CA","US","Voluntary: Firm Initiated","Letter","California and Colorado.","D-622-2013","Class II","INK-EEZE Tattoo Black Label Numbing Spray, a) 0.27 oz. (8 mL), b) 2 oz. (59 mL), No Epinephrine, Active Ingredients: Lidocaine HCl 5% Topical Anesthetic, Distributed by: Indelicare, LLC 914 Tourmaline Drive, Newbury Park, CA 91320, (800) 611-7720, www.inkeeze.com.","Lot #: L0211",,"2849 Bottles","Marketed without an approved NDA/ANDA: INK-EEZE Tattoo Numbing Spray contains 5% Lidocaine and is being marketed without an approved NDA/ANDA. Lidocaine 5% is an ingredient in many FDA approved products, making Ink-Eeze an unapproved new drug.",5/23/2013,"05/23/2013",7/3/2013,"07/03/2013"
"Drugs",65284,"Ongoing","Indelicare LLC","Newbury Park","CA","US","Voluntary: Firm Initiated","Letter","California and Colorado.","D-621-2013","Class II","INK-EEZE Tattoo Numbing Spray, 2 oz. (59 mL), Active Ingredients: Lidocaine HCl 5% Topical Anesthetic, Distributed by: Indelicare, LLC 914 Tourmaline Drive, Newbury Park, CA 91320, (800) 611-7720, www.inkeeze.com","Lot L0207",,"683 Bottles","Marketed without an approved NDA/ANDA: INK-EEZE Tattoo Numbing Spray contains 5% Lidocaine and is being marketed without an approved NDA/ANDA. Lidocaine 5% is an ingredient in many FDA approved products, making Ink-Eeze an unapproved new drug.",5/23/2013,"05/23/2013",7/3/2013,"07/03/2013"
"Devices",65285,"Ongoing","Abbott Medical Optics, Inc.","Milpitas","CA","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution - USA (nationwide) and Internationally to Australia, Belgium, Canada, China, Denmark, Finland, France, Germany, Great Britian, Greece, India, Ireland, Italy, Netherlands, New Zealand, Norway, Poland, Puerto Rico, Singapore, Sweden, Turkey, Japan, Spain, Chile, Argentina, Colombia, Brazil, Taiwan, Mexico, South Korea, Venezuela, Paraquay, South Korea, Russian Federation, Costa Rico, Portugal, Uruquay, Martinique, Israel, Bolivia, Ecuador, Lebanon, Thailand, Saudi Arabia, Egypt, Dominican Republic, United Arab Emirates, Czech Republic, Indonesia, Kuwait, Ukraine, Guatemala, Phillipines, Trinidad, Tobago, Mongolia, Jordan, Malaysia, Hong Kong, Bulgaria, Oman, Kazakhstan, Bulgaria, Peru, Bolivia, Croatia, Romania, Yemen, Vietnam, Uzbekistan, Libyia, Slovakia, Algeria, El Salvador, and Cyprus. .","Z-1539-2013","Class II","STAR S3 ActiveTrack Excimer System (STAR S3) Mfg by AMO Manufacturing USA, LLC 510 cottonwood Drive Milpitas, CA 95035 The STAR Excimer Laser System, a class Ill device, is indicated for laser assisted in situ keratomileusis (LASIK) eye surgery in certain patient populations.","Model 0030-4864 - all serial numbers of STAR Excimer Laser Systems that were manufactured prior to 26-Jul-2011.",".","1,882 total all systems","Under specific conditions, there is an unlikely potential to result in inadvertent laser firing of the laser.",5/28/2013,"05/28/2013",6/19/2013,"06/19/2013"
"Devices",65285,"Ongoing","Abbott Medical Optics, Inc.","Milpitas","CA","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution - USA (nationwide) and Internationally to Australia, Belgium, Canada, China, Denmark, Finland, France, Germany, Great Britian, Greece, India, Ireland, Italy, Netherlands, New Zealand, Norway, Poland, Puerto Rico, Singapore, Sweden, Turkey, Japan, Spain, Chile, Argentina, Colombia, Brazil, Taiwan, Mexico, South Korea, Venezuela, Paraquay, South Korea, Russian Federation, Costa Rico, Portugal, Uruquay, Martinique, Israel, Bolivia, Ecuador, Lebanon, Thailand, Saudi Arabia, Egypt, Dominican Republic, United Arab Emirates, Czech Republic, Indonesia, Kuwait, Ukraine, Guatemala, Phillipines, Trinidad, Tobago, Mongolia, Jordan, Malaysia, Hong Kong, Bulgaria, Oman, Kazakhstan, Bulgaria, Peru, Bolivia, Croatia, Romania, Yemen, Vietnam, Uzbekistan, Libyia, Slovakia, Algeria, El Salvador, and Cyprus. .","Z-1541-2013","Class II","STAR S4 IR Excimer System (STAR S4 IR) Mfg by AMO Manufacturing USA, LLC 510 Cottonwood Drive Milpitas, CA 95035 The STAR Excimer Laser System, a class Ill device, is indicated for laser assisted in situ keratomileusis (LASIK) eye surgery in certain patient populations.","Model 0030-2450 - all serial numbers of STAR Excimer Laser Systems that were manufactured prior to 26-Jul-2011.",".","1,882, total all systems","Under specific conditions, there is an unlikely potential to result in inadvertent laser firing of the laser.",5/28/2013,"05/28/2013",6/19/2013,"06/19/2013"
"Devices",65285,"Ongoing","Abbott Medical Optics, Inc.","Milpitas","CA","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution - USA (nationwide) and Internationally to Australia, Belgium, Canada, China, Denmark, Finland, France, Germany, Great Britian, Greece, India, Ireland, Italy, Netherlands, New Zealand, Norway, Poland, Puerto Rico, Singapore, Sweden, Turkey, Japan, Spain, Chile, Argentina, Colombia, Brazil, Taiwan, Mexico, South Korea, Venezuela, Paraquay, South Korea, Russian Federation, Costa Rico, Portugal, Uruquay, Martinique, Israel, Bolivia, Ecuador, Lebanon, Thailand, Saudi Arabia, Egypt, Dominican Republic, United Arab Emirates, Czech Republic, Indonesia, Kuwait, Ukraine, Guatemala, Phillipines, Trinidad, Tobago, Mongolia, Jordan, Malaysia, Hong Kong, Bulgaria, Oman, Kazakhstan, Bulgaria, Peru, Bolivia, Croatia, Romania, Yemen, Vietnam, Uzbekistan, Libyia, Slovakia, Algeria, El Salvador, and Cyprus. .","Z-1540-2013","Class II","STAR S4 with Variable Spot Scanning Excimer System (STAR S4) Mfg by AMO Manufacturing USA, LLC 510 Cottonwood Drive Milpitas, CA 95035 The STAR Excimer Laser System, a class Ill device, is indicated for laser assisted in situ keratomileusis (LASIK) eye surgery in certain patient populations.","Model 0030-4077 - all serial numbers of STAR Excimer Laser Systems that were manufactured prior to 26-Jul-2011.",".","1,882 - total all systems","Under specific conditions, there is an unlikely potential to result in inadvertent laser firing of the laser.",5/28/2013,"05/28/2013",6/19/2013,"06/19/2013"
"Devices",65286,"Ongoing","Penlon, Ltd.","Abingdon",,"GB","Voluntary: Firm Initiated","Letter","Worldwide Distribution - USA including FL, KY, PA, ND, MN, IL, NJ, TX, TN, and VA. Internationally to Belgium, China, Czech Republic, France, Germany, Switzerland, Australia, Finland, Holland, Lithunia, Malta, Poland, and Slovakia.","Z-1653-2013","Class II","Delta Vaporizer An anesthetic vaporizer is a device used to vaporize liquid anesthetic and deliver a controlled amount of the vapor to the patient.","All; recalled products are traced by serial numbers D0312-XXXX to D1112-XXXX.",".","9208 (of which 576 were within the US)","It has come to Penlon Ltd's attention of an instance where the installation and pre-use checks listed in the User Manual may not have been followed prior to the clinical use of the vaporizer. Penlon Ltd has updated the Installation and daily Pre-Use Check sections of the User Manual to ensure that the instructions are explicit and clear.",5/14/2013,"05/14/2013",7/10/2013,"07/10/2013"
"Drugs",65287,"Ongoing","West-ward Pharmaceutical Corp.","Eatontown","NJ","US","Voluntary: Firm Initiated","Letter","Nationwide","D-691-2013","Class III","Nicardipine Hydrochloride Injection 25 mg/10 mL (2.5 mg/mL), 10 mL single-use vials, Rx Only, Mfd. by Exela Pharma Sciences, LLC, Lenoir, NC, Dist. by: West-ward Pharmaceutical Corp., Eatontown, NJ --- NDC 0143-9689-10","Lot PLNJ1201 APRIL 2014 Lot PLNJ1202 MAY 2014 ",".","Lot PLNJ1201 -16,880 vials ; Lot PLNJ1202 - 16,960 vials ","Failed Impurity/Degradation Specifications; out of specification value for impurity Nitrophenylpuridine Derivative (NPP-D)",5/13/2013,"05/13/2013",7/17/2013,"07/17/2013"
"Drugs",65288,"Ongoing","Baxter Healthcare Corp.","Deerfield","IL","US","Voluntary: Firm Initiated","Letter","Nationwide & Puerto Rico","D-628-2013","Class II","Sodium Chloride Injection, USP, a) Product code 2B1301- 50 mL in Viaflex Container Quad Pack (NDC 0338-0049-11); b) 2B1302- 100mL in Viaflex Quad Pack (NDC 0338-0049-18); c) 2B1306- 50 mL in Viaflex Single Pack (NDC 0338-0049-41; d) 2B1307- 100mL in Viaflex Single Pack (NDC 0338-0049-48); e) 2B1308- 50 ML in Viaflex Multi Pack (NDC 0338-0049-31); f) 2B1309- 100mL in Viaflex Multi Pack (NDC 0338-0049-38), Rx Only, Baxter, Deerfield, IL 60015","Lot #: a) Product code 2B1301: P279943, P280370, Exp 7/13; b) Product code 2B1302: P280248, P280248A, P280248B, P285346, P285791, Exp 8/13; c) Product code 2B1306: P285601, Exp 5/13; d) Product code 2B1307: P280347, Exp 8/13; e) Product code 2B1308: P280404, P280404A, P285635, P285858, Exp 11/13; e) Product code 2B1309: P280149, Exp 8/13 ",".","1,788,292 units","Lack of Assurance of Sterility: Specific lot numbers of these products have been identified for potential administration port leakage. The potential for leakage is the result of a manufacturing issue which occurred during the sealing of the closure assembly at the administration port. ",5/21/2013,"05/21/2013",7/10/2013,"07/10/2013"
"Drugs",65288,"Ongoing","Baxter Healthcare Corp.","Deerfield","IL","US","Voluntary: Firm Initiated","Letter","Nationwide & Puerto Rico","D-626-2013","Class II","Heparin Sodium and 0.9% Sodium Chloride Injection, a) Product code 2B0944, 2000 USP Units, Viaflex Plus Container, 1000mL, (NDC 0338-0433-04), b) Product code 2B0953: 1000 USP Units, Viaflex Plus Container, 500 mL (NDC 0338-0431-03), Baxter, Deerfield, IL 60015","Lot #: a) Product code 2B0944: N001164, Exp 7/13; b) Product code 2B0953: N001396, Exp 11/13",".",,"Lack of Assurance of Sterility: Specific lot numbers of these products have been identified for potential administration port leakage. The potential for leakage is the result of a manufacturing issue which occurred during the sealing of the closure assembly at the administration port. ",5/21/2013,"05/21/2013",7/10/2013,"07/10/2013"
"Drugs",65288,"Ongoing","Baxter Healthcare Corp.","Deerfield","IL","US","Voluntary: Firm Initiated","Letter","Nationwide & Puerto Rico","D-625-2013","Class II","5% Dextrose Injection, USP, in VIAFLEX Plastic Container Multi Pack, Rx Only, a) 50 mL (NDC 0338-0017-31), b) 100 mL (NDC 0338-0017-38), Baxter, Deerfield, IL 60015","Lot #: a) Product code 2B0088: P280115, P285239, Exp 7/13; b) Product code 2B0089: P280230, P280461, P285288, P285288A, P285783, Exp 8/13",".","730,848 units","Lack of Assurance of Sterility: Specific lot numbers of these products have been identified for potential administration port leakage. The potential for leakage is the result of a manufacturing issue which occurred during the sealing of the closure assembly at the administration port. ",5/21/2013,"05/21/2013",7/10/2013,"07/10/2013"
"Drugs",65288,"Ongoing","Baxter Healthcare Corp.","Deerfield","IL","US","Voluntary: Firm Initiated","Letter","Nationwide & Puerto Rico","D-627-2013","Class II","Lidocaine Hydrochloride and 5% Dextrose Injection, USP, 2g VIAFLEX Plus Plastic Container, 500mL, Rx Only, Baxter, Deerfield, IL 60015","Lot #: Product code 2B0973: P279935, Exp 7/13",".",,"Lack of Assurance of Sterilty: Specific lot numbers of these products have been identified for potential administration port leakage. The potential for leakage is the result of a manufacturing issue which occurred during the sealing of the closure assembly at the administration port. ",5/21/2013,"05/21/2013",7/10/2013,"07/10/2013"
"Drugs",65288,"Ongoing","Baxter Healthcare Corp.","Deerfield","IL","US","Voluntary: Firm Initiated","Letter","Nationwide & Puerto Rico","D-624-2013","Class II","0.9% Sodium Chloride Injection, USP, in MINI-BAG Plus Container, a) 50 mL (NDC 0338-0553-11), b) 100 mL (NDC 0338-0553-18), Rx Only, Baxter, Deerfield, IL 60015","Lot #: a) Product code 2B0042: P285668, P285668A, P285668C, P285734, Exp 5/13; b) Product code 2B0043: P285395, Exp 5/13",".","845,520 units","Lack of Assurance of Sterility: Specific lot numbers of these products have been identified for potential administration port leakage. The potential for leakage is the result of a manufacturing issue which occurred during the sealing of the closure assembly at the administration port. ",5/21/2013,"05/21/2013",7/10/2013,"07/10/2013"
"Drugs",65288,"Ongoing","Baxter Healthcare Corp.","Deerfield","IL","US","Voluntary: Firm Initiated","Letter","Nationwide & Puerto Rico","D-629-2014","Class II","Metronidazole Injection USP, RTU, 500 mg/100mL in Viaflex Plus Container, Baxter, Deerfield, IL 60015, NDC 0338-1055-48","Lot #: P280123, P280123A, Exp 2/14",".","172,296 units","Lack of Assurance of Sterility: Specific lot numbers of these products have been identified for potential administration port leakage. The potential for leakage is the result of a manufacturing issue which occurred during the sealing of the closure assembly at the administration port. ",5/21/2013,"05/21/2013",7/10/2013,"07/10/2013"
"Devices",65290,"Ongoing","Zimmer, Inc.","Warsaw","IN","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Nationwide Distribution including IL and MO.","Z-1676-2013","Class II","Bigliani/Flatow The Complete Shoulder Solution, Humeral Stem Provisional 12mm x 170mm This reusable trial device is used in orthopaedic joint replacement and is specific to the replaced joint (e.g. hip, knee, shoulder, ankle, elbow). It can be made of metal or plastic. ","Item 00-4301-012-17; lot 62283991",".","1","The firm is initiating a removal of one lot of the Bigliani/Flatow Humeral Provisional Stem (00-4301-012-17, lot 62283991) as the stems manufactured under the lot are 14mm x 170mm devices incorrectly etched and packaged as 12mm x 170mm devices.",6/11/2013,"06/11/2013",7/17/2013,"07/17/2013"
"Food",65291,"Ongoing","Blessing Seafood, Inc.","Tucson","AZ","US","Voluntary: Firm Initiated","E-Mail","The 16-20 EZ Peel Shrimp was distributed by Perishable Distributors of Iowa (PDI) and sold from February 12 to May 23, 2013 at the seafood display counters in the retail markets seafood section of Hy-Vee stores located in eight states: Iowa, Nebraska, Kansas, Illinois, Missouri, South Dakota, Minnesota, and Wisconsin, and at Cedar Valley Fish Market in Waterloo, Iowa.","F-1528-2013","Class I","Blessing Brand Wild White EZ Peel Shrimp, 16/20 CT. 4 x 5 lbs cartons. The product is bagged in 5 lbs clear plastic bags, the only label iss on the master carton. The product is sold in a seafood retail case. Product labeled as:''WILD WHITE EZ PEEL SHRIMP 16/20 CT WILD CAUGHT PRODUCT OF USA CHEM FREE INGREDIENTS: Shrimp, Salt***PACKED BY: BLESSINGS, INC.***. ","Lot # 13047-1, 13048-1, and 13048-3 ",".","36,920 lbs","Blessing Seafood, Inc. is voluntarily recalling one lot of Blessing Inc. Wild White EZ Peel Shrimp due to undeclared sulfites.",5/24/2013,"05/24/2013",6/19/2013,"06/19/2013"
"Devices",65292,"Ongoing","Abbott Medical Optics, Inc.","Milpitas","CA","US","Voluntary: Firm Initiated","E-Mail","Worldwide Distribution, including Nationwide (US) and countries in Latin America, EMEA, and APAC.","Z-1670-2013","Class II","Sovereign Compact Phacoemulsification System, v 5.3, Part Number: CMP680300. The system is used for cataract surgery.","Product Name: Sovereign Compact Console Universal, Part Number: CMP680300. The Sovereign Compact console is identified with a unique, sequentially assigned 3 digit number identified below as XXX. For Sovereign Compact systems manufactured at the Third Party Manufacturer, Sanmina-SCI Corporation, the serial number format is YYYY35XXX where Y is for the year manufactured and ''35'' designates manufacturing at Sanmina-SCI Corporation. The Sanmina-SCI Corporation started manufacturing the Sovereign Compact v 5.3 systems in February 2012. For Sovereign Compact systems manufactured at the AMO Manufacturing USA, LLC facility in Milpitas, CA the serial number format is YYYY80XXX where Y is for the year manufactured and ''80'' designates manufacturing at Milpitas. The Milpitas facility started manufacturing the v 5.3 systems in February 2013. The serial number is contained in the Product Identification Label (part number Z352548) that is attached to the rear of the console for systems manufactured.",".","534 systems","Abbott Medical Optics Inc. (AMO) initiated this Urgent Notice of Medical Device Correction and Advisory Notice to all customers who use the AMO Sovereign Compact Phacoemulsification System, Version 5.3, because it has the potential to lose the vacuum tone mode during surgery. ",5/23/2013,"05/23/2013",7/17/2013,"07/17/2013"
"Food",65293,"Ongoing","Enzyme Formulations, Inc.","Madison","WI","US","Voluntary: Firm Initiated","Telephone","AL, AR, CA, CO, CT, FL, GA, IA, ID, IL, IN, KY, LA, MA, MI, MO, NC,NV,NY, OH, PA, SC, TX, UT, VA, WA, WI, WV.","F-1551-2013","Class II","Enzyme Solutions, A Dietary Supplement, Formula 29, 8 oz. (226.8g), UPC Code 697706041408. Distributed by: Enzyme Formulations, Inc., Madison, Wisconsin, 53719.","Lot 1225822",,"256 bottles","Enzymes Formulations Inc. is recalling Enzyme Solutions Formula 29 8 oz., lot 1225822 because of a labeling error at the manufacturing. This resulted in 10 jars incorrectly containing a Multiple Enzyme Powder. ",5/15/2013,"05/15/2013",7/3/2013,"07/03/2013"
"Biologics",65294,"Completed","Community Blood Center of the Ozarks","Springfield","MO","US","Voluntary: Firm Initiated","FAX","Switzerland; North Carolina; Austria; Missouri; Arkansas","B-2174-13","Class II","Red Blood Cells","7042343; 7022228; 6955463",".","3 units","Blood products, collected from an ineligible donor, were distributed. ",2/25/2013,"02/25/2013",9/11/2013,"09/11/2013"
"Biologics",65294,"Completed","Community Blood Center of the Ozarks","Springfield","MO","US","Voluntary: Firm Initiated","FAX","Switzerland; North Carolina; Austria; Missouri; Arkansas","B-2173-13","Class II","Red Blood Cells Leukocytes Reduced","W045112354865; W045112346756; W045111266101; W045110206835; W045110186065; W045110168815; W045110128425; W045109111941; ",".","8 units","Blood products, collected from an ineligible donor, were distributed. ",2/25/2013,"02/25/2013",9/11/2013,"09/11/2013"
"Biologics",65294,"Completed","Community Blood Center of the Ozarks","Springfield","MO","US","Voluntary: Firm Initiated","FAX","Switzerland; North Carolina; Austria; Missouri; Arkansas","B-2175-13","Class II","Blood and Blood Products for Reprocessing","W045112354865; W045112346756; W045111266101; W045110206835; W045110186065; W045110168815; W045110128425; W045109111941; 7042343; 7022228; 6955463",".","11 units","Blood products, collected from an ineligible donor, were distributed. ",2/25/2013,"02/25/2013",9/11/2013,"09/11/2013"
"Drugs",65295,"Completed","Physicians Total Care, Inc.","Tulsa","OK","US","Voluntary: Firm Initiated","FAX","Nationwide","D-596-2013","Class III","Voltaren 1% Gel, 100 gm tube, Rx only, Dist By: Physicians Total Care, Tulsa OK 74146, Mfg By: Novartis Consumer Health, Parsippany, NJ 07054, NDC 54868-5965-00","PTC Lot #; Exp Date; Distributor Novartis Lot #. PTC #651L; Exp 03/31/2013; Novartis #10085272. PTC #G8OO; Exp 04/30/2013; Novartis #10088292. PTC #67GO; Exp 04/30/2013; Novartis #10088311. PTC #67J7; Exp 04/30/2013; Novartis #10088311. PTC #68JC; Exp 05/31/2013; Novartis #10088899. PTC #68KA; Exp 05/31/2013; Novartis #10088899. PTC #6B0I; Exp 05/31/2013; Novartis #10088905. PTC #6AA4; Exp 05/31/2013; Novartis #10088907. PTC #6D9R; Exp 07/31/2013; Novartis #10088924. PTC #6DBP; Exp 07/31/2013; Novartis #10088925. PTC #6M81; Exp 07/31/2013; Novartis #10088929. PTC #6ME2; Exp 07/31/2013; Novartis #10088929. PTC #6F98; Exp 08/31/2013; Novartis #10094389. PTC #6QFU; Exp 09/30/2013; Novartis #10094396. PTC #6I2S; Exp 10/31/2013; Novartis #10098702. PTC #6KJG; Exp 12/31/2013; Novartis #10102313. PTC #6KC1; Exp 12/31/2013; Novartis #10102314. PTC #6SQ7; Exp 02/28/2014; Novartis #10104248. PTC #6Q3B; Exp 03/31/2014; Novartis #10107749. PTC #6NRO; Exp 03/31/2014; Novartis #10107750. PTC #6OVH; Exp 03/31/2014; Novartis #10107750. PTC #6QTV; Exp 04/30/2014; Novartis #10110442. PTC #6REN; Exp 04/30/2014; Novartis #10110442. PTC #6ROG; Exp 04/30/2014; Novartis #10110442. PTC #6VGM; Exp 05/31/2014; Novartis #10113476. PTC #6VOR; Exp 05/31/2014; Novartis #10113476. PTC #6VQ2; Exp 05/31/2014; Novartis #10113476. PTC #6VWW; Exp 05/31/2014; Novartis #10113476. PTC #6SQ6; Exp 05/31/2014; Novartis #10113478. PTC #6XO2; Exp 05/31/2014; Novartis #10113481. PTC #6Y4L; Exp 05/31/2014; Novartis #10113481. PTC #6YTH; Exp 05/31/2014; Novartis #10113481. PTC #6V3L; Exp 06/30/2014; Novartis #10115860. PTC #6X79; Exp 09/30/2014; Novartis #10119418. PTC #6WQ4; Exp 09/30/2014; Novartis #10120557. ",".","76 Tubes","Labeling: Incorrect or Missing Lot and/or Expiration Date; This recall is being initiated because the lot number and expiration date on the tube may not be legible.",3/2/2013,"03/02/2013",6/12/2013,"06/12/2013"
"Devices",65296,"Ongoing","Fenwal Inc","Lake Zurich","IL","US","Voluntary: Firm Initiated","Letter","USA Nationwide Distribution","Z-1523-2013","Class II","AMICUS Exchange Kit; Product Usage: This kit is designed for use with the AMICUS separator for the Therapeutic Plasma Exchange (TPE) procedure. Sterilized by irradiation. Sterile fluid path. Non-pyrogenic fluid path. ","Model No.: R4R2339; Lot No.: FA12C07070; Expiration Date: 03/2014 ",".","19 Cases (114 Units)","Fenwal has initiated a voluntary Urgent Product Recall for lot FA12C07070 of product code R4R2339, Amicus Exchange Kits. Fenwal identified a labeling issue with this batch of Product Code R4R2339 (which was cleared for European use only) in which this batch was distributed within the United States market. The problem is identified as labeling that did not include the written description for the symbols used on the label.",5/24/2013,"05/24/2013",6/19/2013,"06/19/2013"
"Devices",65297,"Ongoing","Medtronic Sofamor Danek USA Inc","Memphis","TN","US","Voluntary: Firm Initiated","Letter","Worldwide distribution: USA (nationwide including Puerto Rico) and Internationally to Australia, Brazil, Canada, Chile, Hong Kong, India, Mexico, Netherlands, , New South Wales, Panama, and Paraguay.","Z-1591-2013","Class II","INFUSE(R) Bone Graft, LARGE KIT, REF 7510600, Medtronic Sofamore Danek USA, Inc., 1800 Pyramid Place, Memphis, Tennessee 38132 orthopaedic","Lots: M111052AAE, M111052AAN, M111052AAS, M111052AAD, M111059AAA",,"4885 units ","Kits contain a collagen sponge recalled by Integra due to possible elevated endotoxin levels resulting from a process deviation. ",5/28/2013,"05/28/2013",7/3/2013,"07/03/2013"
"Devices",65297,"Ongoing","Medtronic Sofamor Danek USA Inc","Memphis","TN","US","Voluntary: Firm Initiated","Letter","Worldwide distribution: USA (nationwide including Puerto Rico) and Internationally to Australia, Brazil, Canada, Chile, Hong Kong, India, Mexico, Netherlands, , New South Wales, Panama, and Paraguay.","Z-1590-2013","Class II","INFUSE(R) Bone Graft, MEDIUM KIT, REF 7510400, Medtronic Sofamore Danek USA, Inc., 1800 Pyramid Place, Memphis, Tennessee 38132 orthopaedic","Lots: M111063AAA, M111063AAB, M111064AAI, M111064AAF, M111064AAE, 111064AAT, M111064AAU, M111064AAX, M111064AAJ, M111064AAR, M111064AAS ",,"8884 units ","Kits contain a collagen sponge recalled by Integra due to possible elevated endotoxin levels resulting from a process deviation. ",5/28/2013,"05/28/2013",7/3/2013,"07/03/2013"
"Devices",65297,"Ongoing","Medtronic Sofamor Danek USA Inc","Memphis","TN","US","Voluntary: Firm Initiated","Letter","Worldwide distribution: USA (nationwide including Puerto Rico) and Internationally to Australia, Brazil, Canada, Chile, Hong Kong, India, Mexico, Netherlands, , New South Wales, Panama, and Paraguay.","Z-1593-2013","Class II","INFUSE(R) Bone Graft, SMALL KIT, REF 7510200AUS, Medtronic Sofamore Danek USA, Inc., 1800 Pyramid Place, Memphis, Tennessee 38132 orthopaedic","Lots: M111063AAK, M111064AAH, M111063AAE, M111063AAO ",,"1319 units ","Kits contain a collagen sponge recalled by Integra due to possible elevated endotoxin levels resulting from a process deviation. ",5/28/2013,"05/28/2013",7/3/2013,"07/03/2013"
"Devices",65297,"Ongoing","Medtronic Sofamor Danek USA Inc","Memphis","TN","US","Voluntary: Firm Initiated","Letter","Worldwide distribution: USA (nationwide including Puerto Rico) and Internationally to Australia, Brazil, Canada, Chile, Hong Kong, India, Mexico, Netherlands, , New South Wales, Panama, and Paraguay.","Z-1589-2013","Class II","INFUSE(R) Bone Graft, SMALL KIT, REF 7510200, Medtronic Sofamore Danek USA, Inc., 1800 Pyramid Place, Memphis, Tennessee 38132 orthopaedic","Lots: M111057AAP, M111064AAD, M111064AAC, M111063AAJ, M111064AAK, M111064AAL, M111064AAV, M111064AAM, M111064AAW, M111064AAG, M111057AAM, M111063AAD, M111064AAQ, M111064AAO, M111064AAP, M111063AAP, M111064AAB, M111063AAC, M111064AAY, M111057AAD, M111057AAE",,"22936 units ","Kits contain a collagen sponge recalled by Integra due to possible elevated endotoxin levels resulting from a process deviation. ",5/28/2013,"05/28/2013",7/3/2013,"07/03/2013"
"Devices",65297,"Ongoing","Medtronic Sofamor Danek USA Inc","Memphis","TN","US","Voluntary: Firm Initiated","Letter","Worldwide distribution: USA (nationwide including Puerto Rico) and Internationally to Australia, Brazil, Canada, Chile, Hong Kong, India, Mexico, Netherlands, , New South Wales, Panama, and Paraguay.","Z-1592-2013","Class II","INFUSE(R) Bone Graft,LARGE II KIT, REF 7510800, Medtronic Sofamore Danek USA, Inc., 1800 Pyramid Place, Memphis, Tennessee 38132 orthopaedic","Lots: M111103AAG, M111052AAQ, M111052AAR, M111052AAP, M111052AAL, M111059AAC, M111059AAF, M111052AAF, M111059AAH, M111103AAB, M111059AAG, M111052AAK, M111052AAJ, M111059AAB, M111059AAK, M111052AAI, M111052AAO, M111052AAH, M111052AAG, M111059AAD",,"16994 units ","Kits contain a collagen sponge recalled by Integra due to possible elevated endotoxin levels resulting from a process deviation. ",5/28/2013,"05/28/2013",7/3/2013,"07/03/2013"
"Devices",65297,"Ongoing","Medtronic Sofamor Danek USA Inc","Memphis","TN","US","Voluntary: Firm Initiated","Letter","Worldwide distribution: USA (nationwide including Puerto Rico) and Internationally to Australia, Brazil, Canada, Chile, Hong Kong, India, Mexico, Netherlands, , New South Wales, Panama, and Paraguay.","Z-1595-2013","Class II","INFUSE(R) Bone Graft, LARGE II KIT, REF 7510800AUS, Medtronic Sofamore Danek USA, Inc., 1800 Pyramid Place, Memphis, Tennessee 38132 orthopaedic","Lots: M111103AAC, M111052AAT, M111059AAE, M111054AAR, M111052AAM",,"2090 units ","Kits contain a collagen sponge recalled by Integra due to possible elevated endotoxin levels resulting from a process deviation. ",5/28/2013,"05/28/2013",7/3/2013,"07/03/2013"
"Devices",65297,"Ongoing","Medtronic Sofamor Danek USA Inc","Memphis","TN","US","Voluntary: Firm Initiated","Letter","Worldwide distribution: USA (nationwide including Puerto Rico) and Internationally to Australia, Brazil, Canada, Chile, Hong Kong, India, Mexico, Netherlands, , New South Wales, Panama, and Paraguay.","Z-1594-2013","Class II","INFUSE(R) Bone Graft, MEDIUM KIT, REF 7510400AUS, Medtronic Sofamore Danek USA, Inc., 1800 Pyramid Place, Memphis, Tennessee 38132 orthopaedic","Lots: M111063AAF, M111064AAN",,"400 units ","Kits contain a collagen sponge recalled by Integra due to possible elevated endotoxin levels resulting from a process deviation. ",5/28/2013,"05/28/2013",7/3/2013,"07/03/2013"
"Drugs",65298,"Ongoing","Teva Pharmaceuticals USA, Inc.","Sellersville","PA","US","Voluntary: Firm Initiated","Letter","Product was distributed within the United States to FL, IL, MA, MO, MS, OH and TX. No government or foreign distribution.","D-606-2013","Class II","Actiq (oral transmucosal fentanyl citrate) 200 mcg, lozenge on a stick, a)Single Blister (NDC 63459-502-01), b) 30 count carton (NDC 63459-502-30), Rx only, Manufactured by: Cephalon, Inc., Salt Lake City, UT 84116 ","Lot C88583, exp. 06/15",,"316 cartons","Subpotent Drug: Product is being recalled due to an out of specification dissolution result during stability testing.",5/28/2013,"05/28/2013",6/26/2013,"06/26/2013"
"Food",65299,"Ongoing","Fruit Treasure Inc","San Diego","CA","US","Voluntary: Firm Initiated","E-Mail","Within California.","F-1524-2013","Class I","Fresh Thai chili peppers. Loose fresh Thai chili peppers packaged with inner plastic mesh bag into paper carton cardboard boxes. Imported bulk. Outer carton labeling reads in part: ''***PRODUCE OF MEXICO***JAMMIN PEPPERS***THAI CHILI***DISTRIBUTED BY: JT BROKERAGE 651 KOHLER ST. LOS ANGELES, CA 90021***WWW.JAMMINPEPPERS.COM***''.","Bulk outer carton labelets with Lot # 162. Sold to retail with no coding or marks.",".","25 lb-43cartons","The firm recalled the Thai chili peppers because FDA analytical results revealed the presence of Salmonella.",5/28/2013,"05/28/2013",6/19/2013,"06/19/2013"
"Drugs",65300,"Ongoing","Hospira, Inc.","Lake Forest","IL","US","Voluntary: Firm Initiated","Letter","Nationwide","D-851-2013","Class II","Ondansetron Injection, USP, 4mg/2mL, (2mg/ml), 2mL single-dose Fliptop Vial, Rx only, Sterile, NDC 0409-4755-03, Hospira, Inc, Lake Forest, IL 60045.","Lot 25394DK, exp. 01/2015",".","340,600 vials","Presence of Particulate; lot being recalled as a precaution due to the discovery of 2 particles found in a lot which preceded the recalled lot",5/20/2013,"05/20/2013",8/14/2013,"08/14/2013"
"Devices",65301,"Ongoing","Zimmer, Inc.","Warsaw","IN","US","Voluntary: Firm Initiated","Telephone","Worldwide Distribution-USA (nationwide) including the states of NY, MI, MN, OH, IN, IL, VA, MD, PA, WA, KY, CT, RI, NH, TX, MT, and CA and the countries of Chile, China, South Korea, and Australia.","Z-1620-2013","Class II","Bigliani/Flatow The Complete Solution Fukuda Retractors Large Nonsterile 4305-19-40. Used in retracting the humeral shaft posteriorly and exposing the entire glenoid surface.","Item Number: 00-4305-019-40 with Lot Numbers 61588143 and 61612276. 2010 Market Withdrawal: Item #:430501940 Lot #'s: 60768814, 60806551, 60893241, 60946820, 60999665, 61031668, 61110808, 61170678, 61205673, 61244194, 61392456, 61430127 ",".","722 units (includes 2010 market withdrawal)","This is a recall expansion from the 2010 recall which now includes seven additional lots that were not previously included. Zimmer, Inc. is initiating a recall of small and large Fukuda-type retractors due to fractures occurring at the grooves around the perimeter of the blades while being used during surgery. ",5/23/2013,"05/23/2013",7/10/2013,"07/10/2013"
"Devices",65301,"Ongoing","Zimmer, Inc.","Warsaw","IN","US","Voluntary: Firm Initiated","Telephone","Worldwide Distribution-USA (nationwide) including the states of NY, MI, MN, OH, IN, IL, VA, MD, PA, WA, KY, CT, RI, NH, TX, MT, and CA and the countries of Chile, China, South Korea, and Australia.","Z-1621-2013","Class II","Bigliani/Flatow The Complete Solution Fukuda Retractors Small Nonsterile 00-4305-019-30. Used in retracting the humeral shaft posteriorly and exposing the entire glenoid surface."," Item Number 00-4305-019-30 with Lot Numbers 61557761, 61591732, 61612275, 61614764, and 77000186. 2010 Market Withdrawal part numbers: Item #:430501930, Lot#s: 60795817, 60834923, 60916795, 60997103, 61017041, 61038697, 61075510, 61128521, 61186400, 61199809, 61253702, 61392455, 61430126",".","722 units (includes 2010 market withdrawal)","This is a recall expansion from the 2010 recall which now includes seven additional lots that were not previously included. Zimmer, Inc. is initiating a recall of small and large Fukuda-type retractors due to fractures occurring at the grooves around the perimeter of the blades while being used during surgery. ",5/23/2013,"05/23/2013",7/10/2013,"07/10/2013"
"Food",65302,"Ongoing","Conagra Inc","Omaha","NE","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Distribution was made to AL, AR, AZ, CO, DE,FL,GA, IA, IL, IN, KS, KY, LA, MA, MD, ME, MI, MO, MS, NC, NE, NJ, NM, NY, OH, OK, PA, SC, TN, TX, VA, VT and WI. No foriegn or military distribution was made.","F-1533-2013","Class I","Lightlife Farmer's Market Veggie Burgers, meat free, 12 oz/4-count bag, packaged in 5/12 oz-bag/cartons. Distributed By: Lightlife Foods, Turners Falls, MA. Case UPC Code: 20043454805252","Lot Code: 5483220300 and 5483221700 Best if Used by Dates: JULY 16 2013 and JULY 30 2013.",,"66805/12-oz/4-count package/cases","The product packaging for Lighthouse Farmer's Market Veggie Burgers may contain Lightlife Kick'n Black Bean Burgers which contain milk. The milk allergen is not declared on the Farmer's Market Veggie Burger product label.",5/29/2013,"05/29/2013",6/26/2013,"06/26/2013"
"Devices",65303,"Ongoing","Boston Scientific Corporation","Marlborough","MA","US","Voluntary: Firm Initiated","Letter","Worldwide distribution: US (nationwide) including states of: CA, FL, IA, ID, MI, OK, TA and WA; and countries of: Canada and Thailand.","Z-1748-2013","Class II","Alair Bronchial Thermoplasty Catheter, Bronchial Thermoplasty System; Material Number: M005ATS25010, Catalog Number: ATS 2-5. Product is manufactured and distributed by Boston Scientific Corporation (BSC), Sunnyvale, CA The Alair Bronchial Thermoplasty System (including the Alair Bronchial Thermoplasty Catheter) is indicated for the treatment of severe persistent asthma in patients 18 years and older whose asthma is not well controlled with inhaled corticosteroids and long acting beta agonists.","Lot/batch Number: CM040212; Exp. Date: April 2014",".","35 units","Boston Scientific has discovered an inconsistent ''Use By'' expiration date on a single lot/batch of Alair Bronchial Thermoplasty Catheters. The expiration date indicated on the inner tray, 2012-04, is incorrect. The correct expiration date is 2014-04 as indicated on the outer box label.",5/28/2013,"05/28/2013",7/24/2013,"07/24/2013"
"Food",65304,"Ongoing","Salmolux (A Pacific Seafood Group Company)","Federal Way","WA","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Products were distributed in Arkansas, Arizona, California, Idaho, Michigan, Nevada, New York, Ohio, Texas, and Washington.","F-1597-2013","Class I","''***JENSEN'S SEATTLE STYLE SMOKED WILD PACIFIC SALMON ***JENSEN'S SMOKEHOUSE, INC.***10520 GREENWOOD AVE N***SEATTLE, WA 98133*** (206) 364-5569** SOCKEYE LOX Net Wt. 4 oz***''. ","Production Lot 10803. The code is breaking down as: 1 and 3 are the year 2013. 080 is the Julian date, the 80th of the year (or March 21st). Retail stores issue the best-by date based on when they thaw the product.",".","total 4930 lbs.","Cold Smoked Salmon products are recalled due to the potential contamination with Listeria monocytogenes.",5/25/2013,"05/25/2013",7/17/2013,"07/17/2013"
"Food",65304,"Ongoing","Salmolux (A Pacific Seafood Group Company)","Federal Way","WA","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Products were distributed in Arkansas, Arizona, California, Idaho, Michigan, Nevada, New York, Ohio, Texas, and Washington.","F-1598-2013","Class II","SOCKEYE SALMON: 1) ''***SMOKED WILD SOCKEYE SALMON (NOVA LOX)***INGREDIENTS: Wild Sockeye Salmon, Salt, Sugar, Natural Wood Smoke. CONTAINS: SOCKEYE SALMON (FISH)***Produced By: SALMOLUX, 34100 9th Avenue S. Federal Way. WA 98003***''. 2) ''***SOCKEYE SMOKED SALMON TRIM***NET WT: 2 lbs (908g)***INGREDIENTS: Wild Sockeye Salmon, Salt, Sugar, Natural Wood Smoke. (No Preservatives or Artificial Colors)***Produced By: SALMOLUX, 34100 9th Avenue S. Federal Way. WA 98003***''. 3) ''***SMOKED SOCKEYE SALMON (NOVA LOX)***Net Wt. 4 oz (113g)***INGREDIENTS: Alaskan Sockeye Salmon, Salt, Sugar, Natural Wood Smoke. CONTAINS: FISH (SALMON)***0 16468 44900 8***''. ","Production Lot 10803. The code is breaking down as: 1 and 3 are the year 2013. 080 is the Julian date, the 80th of the year (or March 21st). Retail stores issue the best-by date based on when they thaw the product.",".",,"Cold Smoked Salmon products are recalled due to the potential contamination with Listeria monocytogenes.",5/25/2013,"05/25/2013",7/17/2013,"07/17/2013"
"Food",65304,"Ongoing","Salmolux (A Pacific Seafood Group Company)","Federal Way","WA","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Products were distributed in Arkansas, Arizona, California, Idaho, Michigan, Nevada, New York, Ohio, Texas, and Washington.","F-1599-2013","Class II","ATLANTIC SALMON: 1) ''***Raley's***NOVA LOX***NET WT 4 OZ (113 g)***INGREDIENTS: ATLANTIC SALMON (FARM RAISED-COLOR ADDED), SALT, SUGAR, SODIUM NITRITE, NATURAL WOOD SMOKE. CONTAINS: SALMON (FISH)***READY TO EAT***REFRIGERATED BELOW 38F***Proudly Distributed By: Raley's, 500 West Capitol Avenue, West Sacramento, CA 95605***0 46567 50029 4***''. 2) ''***LOX TRIM*** NET WT: 2 lbs (908g)***INGREDIENTS: Atlantic Salmon (Farm Raised-Color Added), Salt, Sugar, Sodium Nitrite, Natural Wood Smoke. CONTAINS: ATLANTIC SALMON (FISH)***Produced By: SALMOLUX, 34100 9th Avenue S. Federal Way. WA 98003***''. 3) ''***SMOKED SALMON NOVA LOX (Pre-Sliced)***NET WT: 3 lbs ( 1 .36kg)***INGREDIENTS: Atlantic Salmon (Farm Raised-Color Added), Salt, Sugar, Sodium Nitrite, Natural Wood Smoke***Produced By: SALMOLUX, 34100 9th Avenue S. Federal Way. WA 98003***0 16468 42072 4***''. ","Production Lot 10803. The code is breaking down as: 1 and 3 are the year 2013. 080 is the Julian date, the 80th of the year (or March 21st). Retail stores issue the best-by date based on when they thaw the product.",".",,"Cold Smoked Salmon products are recalled due to the potential contamination with Listeria monocytogenes.",5/25/2013,"05/25/2013",7/17/2013,"07/17/2013"
"Food",65304,"Ongoing","Salmolux (A Pacific Seafood Group Company)","Federal Way","WA","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Products were distributed in Arkansas, Arizona, California, Idaho, Michigan, Nevada, New York, Ohio, Texas, and Washington.","F-1600-2013","Class II","KETA SALMON: 1) ''***ALASKAN SMOKED SALMON (NOVA LOX)***Net WT. 16 oz (454g)***INGREDIENTS: Wild Keta Salmon, Salt, Sugar, Sodium Nitrite, FD&C Yellow #6 & Red #40, Natural Wood Smoke. CONTAINS: FISH (SALMON)***0 16468 44294 8***''. 2) ''***WILD KETA SMOKED SALMON (NOVA LOX) TRIM***NET WT: 2 lbs (908g)***INGREDIENTS. Wild Keta Salmon, Salt, Sugar, Sodium Nitrite, FD&C Yellow #6 & Red #40. Natural Wood Smoke. CONTAINS: WILD KETA SALMON (FISH)***Produced By: SALMOLUX, 34100 9th Avenue S. Federal Way. WA 98003***''. 3) ''***SMOKED SALMON (NOVA LOX)***Net Wt. 4 oz (113g)***INGREDIENTS: Wild Keta Salmon, Salt, Sugar, Sodium Nitrite, FD&C Yellow #6 & Red #40, Natural Wood Smoke. CONTAINS: KETA SALMON (FISH)***0 16468 44305 1***''. ","Production Lot 10803. The code is breaking down as: 1 and 3 are the year 2013. 080 is the Julian date, the 80th of the year (or March 21st). Retail stores issue the best-by date based on when they thaw the product.",".",,"Cold Smoked Salmon products are recalled due to the potential contamination with Listeria monocytogenes.",5/25/2013,"05/25/2013",7/17/2013,"07/17/2013"
"Food",65304,"Ongoing","Salmolux (A Pacific Seafood Group Company)","Federal Way","WA","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Products were distributed in Arkansas, Arizona, California, Idaho, Michigan, Nevada, New York, Ohio, Texas, and Washington.","F-1601-2013","Class II","''***WILD ALASKAN NOVA LOX SMOKED SALMON***Sea Passion***INGREDIENTS: Wild Alaskan Salmon, Salt, Sugar, Sodium Nitrite, FD&C Yellow #6, FD&C Red #40 (color enhancers), Natural Wood Smoke. CONTAINS: FISH (SALMON)*** Salmolux Federal Way, WA 98003***0 16468 44543 7***''. ","Production Lot 10803. The code is breaking down as: 1 and 3 are the year 2013. 080 is the Julian date, the 80th of the year (or March 21st). Retail stores issue the best-by date based on when they thaw the product.",".",,"Cold Smoked Salmon products are recalled due to the potential contamination with Listeria monocytogenes.",5/25/2013,"05/25/2013",7/17/2013,"07/17/2013"
"Food",65304,"Ongoing","Salmolux (A Pacific Seafood Group Company)","Federal Way","WA","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Products were distributed in Arkansas, Arizona, California, Idaho, Michigan, Nevada, New York, Ohio, Texas, and Washington.","F-1602-2013","Class II","''***NORWEGIAN SMOKED SALMON (NOVA LOX)***Net Wt. 8 oz (227g)***INGREDIENTS: Atlantic Salmon (Farm Raised-Color Added), Salt, Sugar, Sodium Nitrite, Natural Wood Smoke. CONTAINS: FISH (SALMON)***0 16468 44328 0***''. ","Production Lot 10803. The code is breaking down as: 1 and 3 are the year 2013. 080 is the Julian date, the 80th of the year (or March 21st). Retail stores issue the best-by date based on when they thaw the product.",".",,"Cold Smoked Salmon products are recalled due to the potential contamination with Listeria monocytogenes.",5/25/2013,"05/25/2013",7/17/2013,"07/17/2013"
"Biologics",65305,"Terminated","Community Blood Centers of Florida, Inc.","Miami","FL","US","Voluntary: Firm Initiated","Telephone","FL","B-2155-13","Class II","Red Blood Cells","2436253",".","1 unit","Blood products, collected from a donor for whom donor suitability was not adequately determined, were distributed.",5/22/2013,"05/22/2013",9/11/2013,"09/11/2013"
"Biologics",65306,"Terminated","Community Blood Centers of South Florida, Inc.","Hialeah","FL","US","Voluntary: Firm Initiated","Telephone","Florida","B-2086-13","Class III","Blood and Blood Products for Reprocessing","W036813039581; ",,"1","Blood products, collected from a donor whose suitability to donate was not adequately determined, were distributed.",5/17/2013,"05/17/2013",9/4/2013,"09/04/2013"
"Biologics",65306,"Terminated","Community Blood Centers of South Florida, Inc.","Hialeah","FL","US","Voluntary: Firm Initiated","Telephone","Florida","B-2085-13","Class II","Platelets Pooled Leukocytes Reduced","W036813800475; ",,"1","Blood products, collected from a donor whose suitability to donate was not adequately determined, were distributed.",5/17/2013,"05/17/2013",9/4/2013,"09/04/2013"
"Biologics",65306,"Terminated","Community Blood Centers of South Florida, Inc.","Hialeah","FL","US","Voluntary: Firm Initiated","Telephone","Florida","B-2087-13","Class II","Red Blood Cells Leukocytes Reduced","W036813039581; ",,"1","Blood products, collected from a donor whose suitability to donate was not adequately determined, were distributed.",5/17/2013,"05/17/2013",9/4/2013,"09/04/2013"
"Biologics",65306,"Terminated","Community Blood Centers of South Florida, Inc.","Hialeah","FL","US","Voluntary: Firm Initiated","Telephone","Florida","B-2084-13","Class II","Red Blood Cells (Apheresis) Leukocytes Reduced Irradiated","W036809231339; W036809231339; ",,"2","Blood products, collected from a donor whose suitability to donate was not adequately determined, were distributed.",5/17/2013,"05/17/2013",9/4/2013,"09/04/2013"
"Biologics",65307,"Terminated","Community Blood Centers of South Florida, Inc.","Lake Worth","FL","US","Voluntary: Firm Initiated","Telephone","Florida","B-2172-13","Class II","Fresh Frozen Plasma","2559582; 2551960; ",".","2 units","Blood products, collected from an ineligible donor, were distributed. ",5/16/2013,"05/16/2013",9/11/2013,"09/11/2013"
"Biologics",65307,"Terminated","Community Blood Centers of South Florida, Inc.","Lake Worth","FL","US","Voluntary: Firm Initiated","Telephone","Florida","B-2171-13","Class II","Red Blood Cells","2559582; 2366969; 2251960",".","3 units","Blood products, collected from an ineligible donor, were distributed. ",5/16/2013,"05/16/2013",9/11/2013,"09/11/2013"
"Biologics",65307,"Terminated","Community Blood Centers of South Florida, Inc.","Lake Worth","FL","US","Voluntary: Firm Initiated","Telephone","Florida","B-2170-13","Class II","Platelets","2559582",".","1 unit","Blood products, collected from an ineligible donor, were distributed. ",5/16/2013,"05/16/2013",9/11/2013,"09/11/2013"
"Biologics",65308,"Terminated","Community Blood Centers of South Florida, Inc.","Hialeah","FL","US","Voluntary: Firm Initiated","Letter","Florida","B-2168-13","Class III","Blood and Blood Products for Reprocessing","W036812427152",".","1 unit","Blood products, collected from an ineligible donor, were distributed. ",5/7/2013,"05/07/2013",9/11/2013,"09/11/2013"
"Biologics",65308,"Terminated","Community Blood Centers of South Florida, Inc.","Hialeah","FL","US","Voluntary: Firm Initiated","Letter","Florida","B-2169-13","Class II","Red Blood Cells","W036812427152",".","1 unit","Blood products, collected from an ineligible donor, were distributed. ",5/7/2013,"05/07/2013",9/11/2013,"09/11/2013"
"Biologics",65310,"Terminated","Community Blood Center","Dayton","OH","US","Voluntary: Firm Initiated","Telephone","Ohio","B-2080-13","Class III","Red Blood Cells Leukocytes Reduced Irradiated","W035413025254; ",,"1","Blood product, not labeled with a tag indicating that it contained anti-D, was distributed.",5/2/2013,"05/02/2013",9/4/2013,"09/04/2013"
"Biologics",65311,"Terminated","Amer. National Red Cross-Greater Chesapeake & Potomac Reg.","Baltimore","MD","US","Voluntary: Firm Initiated","Other","California","B-1915-13","Class III","Blood and Blood Products for Reprocessing","053GR07822; ",,"1","Blood product, collected from a donor whose suitability to donate was not adequately determined, was distributed.",4/19/2013,"04/19/2013",9/4/2013,"09/04/2013"
"Biologics",65312,"Terminated","Biomat USA, Inc.","Bakersfield","CA","US","Voluntary: Firm Initiated","E-Mail","Spain; California","B-2079-13","Class II","Source Plasma","0540305112; 0540299878; 0540299123; 0540298708; 0540297984; 0540297639; 0540297010; 0540296696; 0540302044; 0540301329; 0540300997; 0540300333; ",,"12","Blood products, collected from a donor who received a tattoo within 12 months of donating, were distributed.",5/15/2013,"05/15/2013",9/4/2013,"09/04/2013"
"Biologics",65313,"Terminated","BioLife Plasma Services L.P.","Tyler","TX","US","Voluntary: Firm Initiated","Other","Austria","B-2078-13","Class II","Source Plasma","12TTXC9869; ",,"1","Blood product, collected from a donor who was allowed to donate without a current physical, was distributed. ",4/19/2013,"04/19/2013",9/4/2013,"09/04/2013"
"Devices",65314,"Ongoing","Coloplast Manufacturing US, LLC","Minneapolis","MN","US","Voluntary: Firm Initiated","Letter","US Distribution to: KY, MI, OH, PR, TX, and VA.","Z-1486-2013","Class II","Digitex Absorbable Polydiaxanone Suture, Size 2-0. Catalog Number / Code of product: 52031, 5203101400. The Digitex Delivery Device is a sterile, disposable device intended to deliver a suture to the operative site. The device assists in suturing by passing a needle through the tissue to capture the suture, and suture ligation and know-typing by holding the suture. ","Lots 3390331, 3390339, 3390490.",".","772 units","Coloplast is conducting a recall on three lots of Digitex Absorbable Polydiaxanone Suture, Size 2-0 because it is mislabeled with a three year expiration date. ",5/13/2013,"05/13/2013",6/12/2013,"06/12/2013"
"Drugs",65315,"Ongoing","Hospira Inc.","Lake Forest","IL","US","Voluntary: Firm Initiated","Letter","Nationwide and Puerto Rico","D-501-2013","Class II","Diazepam Injection, USP 5 mg/mL, 10 mL, Multiple-dose fliptop vial, RX only, HOSPIRA, INC. LAKE FOREST, IL 60045 USA, NDC 0409-3213-12","17-099-EV Exp 05/14",".","95,700 vials","Lack of Assurance of Sterility: Loose crimp applied to the fliptop vial.",5/16/2013,"05/16/2013",6/12/2013,"06/12/2013"
"Veterinary",65316,"Ongoing","RI Textile Company","Pawtucket","RI","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Nationwide","V-225-2013","Class II","Pet Shoppe Chicken Jerky premium chicken dog treats, packaged in 20 ounce bags and 3.5 ounce bags. Distributed by Walgreen Co. Deerfield , IL Product Code: 7NPS420672 (3.5 ounce) and 7NPS420673 (20 ounce) Made in China","Lot Number/Best By Date: Y101E28B12884 , 3.5 oz (Best By: 06/26/2014) Y101I16B15284 , 20 oz (Best By: 10/03/2014) Y101H29B15029 , 20 oz (Best By: 09/19/2014) Y101H16B12775, 20 oz. (Best By: 08/29/2014) ",".","20 oz -61348 bags and 3.2 oz -16031 bags","Pet treats contain trace amount of antibiotics",5/24/2013,"05/24/2013",7/24/2013,"07/24/2013"
"Devices",65317,"Ongoing","Boston Scientific Corporation","Marlborough","MA","US","Voluntary: Firm Initiated","Letter","Worldwide distribution: USA (nationwide) including states of: NJ, NY, OH, IL, MI, MD, MA and countries of: Denmark, Great Britain, and Spain.","Z-1672-2013","Class II","NephroMax high Pressure Nephrostomy Balloon Catheter. Material Number/Catalog Number: M0062101400/210-140, M062101440/210144 Dilation of the nephrostomy tract.","Lot Number: 15875861, 15875860, 15875299, 15872797, 15872799, 15872798",".","27","Incorrect sized renal sheath was packaged with the NephroMax high pressure nephrostomy Balloon Catheter.",5/28/2013,"05/28/2013",7/17/2013,"07/17/2013"
"Devices",65317,"Ongoing","Boston Scientific Corporation","Marlborough","MA","US","Voluntary: Firm Initiated","Letter","Worldwide distribution: USA (nationwide) including states of: NJ, NY, OH, IL, MI, MD, MA and countries of: Denmark, Great Britain, and Spain.","Z-1673-2013","Class II","NephroMax high Pressure nephrostomy Balloon Catheter Kit. Material Number/Catalog Number: M0062101600/210-160, M0062101640/210-164 Dilation of the nephrostomy tract. ","Lot Number: 15982017, 15963887, 16034014",".","15 units","Incorrect sized renal sheath was packaged with the NephroMax high pressure nephrostomy Balloon Catheter.",5/28/2013,"05/28/2013",7/17/2013,"07/17/2013"
"Drugs",65318,"Ongoing","Sandoz Incorporated","Broomfield","CO","US","Voluntary: Firm Initiated","Letter","Nationwide and Puerto Rico.","D-597-2013","Class II","Cefazolin, injection, 1 gram per vial, 25 vials per box, sterile, Rx only, single-use vial, Manufactured in Austria by Sandoz GmbH for Sandoz, Inc. Princeton, NJ 08540, NDC 00781-3451-70 (vial), NDC 00781-3451-96 (box)","Lot #: DB2208, Exp 01/16",".","297,200 vials","Lack of Assurance of Sterility: Sandoz Inc is recalling Cefazolin for Injection, USP 1 gm vials, lot DB2208, due to a customer complaint for broken/cracked vials which was confirmed through review of retained samples.",5/30/2013,"05/30/2013",6/19/2013,"06/19/2013"
"Food",65319,"Ongoing","Food Concepts","Lebanon","TN","US","Voluntary: Firm Initiated","Telephone","SC","F-1591-2013","Class II","BIG COUNTRY BREAKFAST, CASE WEIGHT 26 LBS., MANUFACTURED BY: FOOD CONCEPTS, LEBANON, TN 37087","0281301 and 0281302",".","43 cases","Products contain texturized soy protein which was recalled by CHS, Inc. due to possible salmonella contamination.",5/21/2013,"05/21/2013",7/10/2013,"07/10/2013"
"Food",65319,"Ongoing","Food Concepts","Lebanon","TN","US","Voluntary: Firm Initiated","Telephone","SC","F-1593-2013","Class II","RAGIN' CAJUN, WEIGHT 32 LBS, MANUFACTURED BY: FOOD CONCEPTS, LEBANON, TN 37087","0281301, 1191301, and 0351301",".","76 cases","Products contain texturized soy protein which was recalled by CHS, Inc. due to possible salmonella contamination.",5/21/2013,"05/21/2013",7/10/2013,"07/10/2013"
"Food",65319,"Ongoing","Food Concepts","Lebanon","TN","US","Voluntary: Firm Initiated","Telephone","SC","F-1592-2013","Class II","SPANISH SENSATION, NET WEIGHT 32 LBS, MANUFACTURED BY: FOOD CONCEPTS, LEBANON, TN 37087","3101201 and 0351301",".","29 cases","Products contain texturized soy protein which was recalled by CHS, Inc. due to possible salmonella contamination.",5/21/2013,"05/21/2013",7/10/2013,"07/10/2013"
"Devices",65320,"Ongoing","Linvatec Corp. dba ConMed Linvatec","Largo","FL","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Worldwide Distribution-USA (nationwide) including the states of AR, CA, FL, GA, IL, IN, KS, MO, NC, NJ, NM, NY, OH, OK, PA, TN, TX, UT, VA, and WI, and the countries of Austria; Belgium, Canada, China, Czech Republic, Finland, France, Great Britain, Italy, and Japan.","Z-1681-2013","Class II","***REF C7122***QTY 1***APEX Arthroscopy Tubing Set. Intended for use for joint irrigation and dissention during arthroscopic procedures.","C7122 Lots #'s: 1301224, 1301234, 1301244, 1301304, 1301314, 1302114, 1302154, 1302274, 1302284, 1303144, 1303254, 1304044, 1304234, 1304244, and 1305024",".","4,691 units, total of each","Conmed Linvatec received complaints that their products C7120 APEX Arthroscopy Tubing Set, One Connection and C7122 APEX Arthroscopy Tubing Set, Two Connection, contained a scratch/grooved area on the inside diameter of the pressure fitting that may cause the APEX Irrigation (pump) Console to sense a pressure drop and increase fluid flow to the surgical site. ",5/30/2013,"05/30/2013",7/17/2013,"07/17/2013"
"Devices",65320,"Ongoing","Linvatec Corp. dba ConMed Linvatec","Largo","FL","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Worldwide Distribution-USA (nationwide) including the states of AR, CA, FL, GA, IL, IN, KS, MO, NC, NJ, NM, NY, OH, OK, PA, TN, TX, UT, VA, and WI, and the countries of Austria; Belgium, Canada, China, Czech Republic, Finland, France, Great Britain, Italy, and Japan.","Z-1680-2013","Class II","***REF C7120***APEX Arthroscopy Tubing Set. Intended for use for joint irrigation and dissention during arthroscopic procedures.","C7120 Lot's #: 1301184, 1301214, 1301254, 1301284, 1301294, 1302014, 1302044, 1302054, 1302064, 1302074, 13020124, 1302134, 1302144, 1302194, 1302204, 1302214, 1302224, 1302254, 1302264, 1303014, 1303054, 1303064, 1303074, 1303114, 1303124, 1303204, 1303214, 1303264, 1303274, 1303284, 1304014, 1304034, 1304054, 1304154, 1304294, 1304304, and 1305014.",".","4,691 Units total of each","Conmed Linvatec received complaints that their products C7120 APEX Arthroscopy Tubing Set, One Connection and C7122 APEX Arthroscopy Tubing Set, Two Connection, contained a scratch/grooved area on the inside diameter of the pressure fitting that may cause the APEX Irrigation (pump) Console to sense a pressure drop and increase fluid flow to the surgical site. ",5/30/2013,"05/30/2013",7/17/2013,"07/17/2013"
"Devices",65321,"Ongoing","Stryker Instruments Div. of Stryker Corporation","Portage","MI","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","USA Nationwide Distribution","Z-1501-2013","Class II","Stryker Instruments 0400-840-000 T4 Toga, Zipper, Large, Sterile, EO; single use; Product Usage: Protection System and are intended to protect the patient, healthcare personnel and operating room personnel against contamination, exposure of infectious bodily fluids, and the transfer of microorganismsand particulate material. ","1105390, 1107543",".","9,930 units (993 boxes)","Based on an accelerated aging test for this product packaging, there is an indicator of potential for a breach in the sterile barrier in the header bag and potentially the blue sterilization wrap for togas within the second and third year of shelf life. The test method used involved high heat to accelerate the aging of the packaging. Stryker is conducting additional testing and assessing this product packaging while initiating this recall to reduce risk of patient harm related to the remote possibility of patient infection, if a breach in packaging were present.",5/23/2013,"05/23/2013",6/12/2013,"06/12/2013"
"Devices",65321,"Ongoing","Stryker Instruments Div. of Stryker Corporation","Portage","MI","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","USA Nationwide Distribution","Z-1496-2013","Class II","Stryker Instruments 0400-820-000 T4 Zipper Toga (L/XL) Sterile, O; single use; Product Usage: Protection System and are intended to protect the patient, healthcare personnel and operating room personnel against contamination, exposure of infectious bodily fluids, and the transfer of microorganismsand particulate material. ","1005097, 1009205, 1011294, 1102105, 1104268, 1106463, 1108633, 1109857, 1005098, 1009219, 1012313, 1102109, 1104305, 1106465, 1108648, 1109812, 1005104, 1008192, 1011281, 1102119, 1104307, 1106470, 1108654, 1109860, 1005105, 1009213, 1012325, 1102123, 1104308, 1107493, 1108659, 1109817, 1005110, 1009197, 1012327, 1102141, 1104320, 1107488, 1108666, 1005111, 1009204, 1012335, 1102147, 1104327, 1107497, 1108667, 1005118, 1010227, 1012345, 1102150, 1105370, 1106474, 1108671, 1006123, 1010234, 1101014, 1103170, 1105342, 1107511, 1108675, 1007155, 1010235, 1012344, 1103171, 1105356, 1107512, 1108701, 1006127, 1010251, 1101003, 1103223, 1105110, 1107516, 1108704, 1006133, 1010258, 1101017, 1103189, 1105379, 1107537, 1109778, 1006140, 1010243, 1101002, 1103194, 1105390, 1107546, 1107520, 1008181, 1012314, 1101029, 1103184, 1105401, 1107595, 1108710, 1007163, 1010259, 1101046, 1103227, 1106418, 1107604, 1108713, 1007145, 1010252, 1101053, 1104280, 1106432, 1107561, 1109740, 1007156, 1011266, 1102073, 1104248, 1106453, 1108624, 1109750, 1007169, 1011267, 1102092, 1104259, 1106444, 1107599, 1109729, 1007151, 1011275, 1101055, 1104264, 1106451, 1107567, 1109735, 1008176, 1011280, 1102085, 1104290, 1106437, 1107578, 1109755, 1008178, 1011295, 1102099, 1104278, 1106455, 1107570, 1109781, 1008188, 1011276, 1102080, 1104283, 1106460, 1108619, and 1109809.",".","334,520 units (33,452 boxes)","Based on an accelerated aging test for this product packaging, there is an indicator of potential for a breach in the sterile barrier in the header bag and potentially the blue sterilization wrap for togas within the second and third year of shelf life. The test method used involved high heat to accelerate the aging of the packaging. Stryker is conducting additional testing and assessing this product packaging while initiating this recall to reduce risk of patient harm related to the remote possibility of patient infection, if a breach in packaging were present.",5/23/2013,"05/23/2013",6/12/2013,"06/12/2013"
"Devices",65321,"Ongoing","Stryker Instruments Div. of Stryker Corporation","Portage","MI","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","USA Nationwide Distribution","Z-1500-2013","Class II","Stryker Instruments 0400-830-000 T4 Toga, Zipper, Regular, Sterile, EO; single use; Product Usage: Protection System and are intended to protect the patient, healthcare personnel and operating room personnel against contamination, exposure of infectious bodily fluids, and the transfer of microorganismsand particulate material. ","1006141, 1012303, 1102110, 1104324, and 1108664 ",".","5,000 units ( 500 boxes)","Based on an accelerated aging test for this product packaging, there is an indicator of potential for a breach in the sterile barrier in the header bag and potentially the blue sterilization wrap for togas within the second and third year of shelf life. The test method used involved high heat to accelerate the aging of the packaging. Stryker is conducting additional testing and assessing this product packaging while initiating this recall to reduce risk of patient harm related to the remote possibility of patient infection, if a breach in packaging were present.",5/23/2013,"05/23/2013",6/12/2013,"06/12/2013"
"Devices",65321,"Ongoing","Stryker Instruments Div. of Stryker Corporation","Portage","MI","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","USA Nationwide Distribution","Z-1497-2013","Class II","Stryker Instruments 0400-820-000S3 T4 Toga w/Inside Shoulder Ties, Sterile, O; single use; Product Usage: Protection System and are intended to protect the patient, healthcare personnel and operating room personnel against contamination, exposure of infectious bodily fluids, and the transfer of microorganismsand particulate material. ","1007145, 1101004, 1107487",".","3000 units (300 boxes)","Based on an accelerated aging test for this product packaging, there is an indicator of potential for a breach in the sterile barrier in the header bag and potentially the blue sterilization wrap for togas within the second and third year of shelf life. The test method used involved high heat to accelerate the aging of the packaging. Stryker is conducting additional testing and assessing this product packaging while initiating this recall to reduce risk of patient harm related to the remote possibility of patient infection, if a breach in packaging were present.",5/23/2013,"05/23/2013",6/12/2013,"06/12/2013"
"Devices",65321,"Ongoing","Stryker Instruments Div. of Stryker Corporation","Portage","MI","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","USA Nationwide Distribution","Z-1492-2013","Class II","Stryker Instruments0400-750-000 T4 Toga, Pullover, Regular Sterile, EO; single use; Product Usage: Protection System and are intended to protect the patient, healthcare personnel and operating room personnel against contamination, exposure of infectious bodily fluids, and the transfer of microorganismsand particulate material. ","1005111, 1011282,1107491, 1107492",".","3,000 units (300 boxes)","Based on an accelerated aging test for this product packaging, there is an indicator of potential for a breach in the sterile barrier in the header bag and potentially the blue sterilization wrap for togas within the second and third year of shelf life. The test method used involved high heat to accelerate the aging of the packaging. Stryker is conducting additional testing and assessing this product packaging while initiating this recall to reduce risk of patient harm related to the remote possibility of patient infection, if a breach in packaging were present.",5/23/2013,"05/23/2013",6/12/2013,"06/12/2013"
"Devices",65321,"Ongoing","Stryker Instruments Div. of Stryker Corporation","Portage","MI","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","USA Nationwide Distribution","Z-1498-2013","Class II","Stryker Instruments 0400-820-000S7 T4 XXL Toga w/T3 Cut, Sterile, O; single use; Product Usage: Protection System and are intended to protect the patient, healthcare personnel and operating room personnel against contamination, exposure of infectious bodily fluids, and the transfer of microorganismsand particulate material. ","1005098, 1010228, 1012337, 1105367",".","3,980 units ( 398 boxes)","Based on an accelerated aging test for this product packaging, there is an indicator of potential for a breach in the sterile barrier in the header bag and potentially the blue sterilization wrap for togas within the second and third year of shelf life. The test method used involved high heat to accelerate the aging of the packaging. Stryker is conducting additional testing and assessing this product packaging while initiating this recall to reduce risk of patient harm related to the remote possibility of patient infection, if a breach in packaging were present.",5/23/2013,"05/23/2013",6/12/2013,"06/12/2013"
"Devices",65321,"Ongoing","Stryker Instruments Div. of Stryker Corporation","Portage","MI","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","USA Nationwide Distribution","Z-1493-2013","Class II","Stryker Instruments 0400-760-000 T4 Toga, Pullover, Large Sterile, EO; single use; Product Usage: Protection System and are intended to protect the patient, healthcare personnel and operating room personnel against contamination, exposure of infectious bodily fluids, and the transfer of microorganismsand particulate material. ","1006134, 1012304, 1104308, 1007152, 1101020, 1105365, 1007170, 1102080, 1106421, 1008188, 1102147, 1106469, 1009205, 1103193, 1108628, 1010229, 1103198, 1108697, 1010253, 1102149, 1109789, 1011277, 1104248",".","34,640 units (3,464 boxes)","Based on an accelerated aging test for this product packaging, there is an indicator of potential for a breach in the sterile barrier in the header bag and potentially the blue sterilization wrap for togas within the second and third year of shelf life. The test method used involved high heat to accelerate the aging of the packaging. Stryker is conducting additional testing and assessing this product packaging while initiating this recall to reduce risk of patient harm related to the remote possibility of patient infection, if a breach in packaging were present.",5/23/2013,"05/23/2013",6/12/2013,"06/12/2013"
"Devices",65321,"Ongoing","Stryker Instruments Div. of Stryker Corporation","Portage","MI","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","USA Nationwide Distribution","Z-1489-2013","Class II","Stryker Instruments 0400-710-000 T4 Pullover Toga (S/M) Sterile, EO; single use; Product Usage: Protection System and are intended to protect the patient, healthcare personnel and operating room personnel against contamination, exposure of infectious bodily fluids, and the transfer of microorganismsand particulate material. ","1006134, 1101020, 1106424",".","2,980 units (298 boxes) ","Based on an accelerated aging test for this product packaging, there is an indicator of potential for a breach in the sterile barrier in the header bag and potentially the blue sterilization wrap for togas within the second and third year of shelf life. The test method used involved high heat to accelerate the aging of the packaging. Stryker is conducting additional testing and assessing this product packaging while initiating this recall to reduce risk of patient harm related to the remote possibility of patient infection, if a breach in packaging were present.",5/23/2013,"05/23/2013",6/12/2013,"06/12/2013"
"Devices",65321,"Ongoing","Stryker Instruments Div. of Stryker Corporation","Portage","MI","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","USA Nationwide Distribution","Z-1503-2013","Class II","Stryker Instruments 0400-850-000S2 T4 Toga, XL, w/Inside Tie) Sterile, EO; single use; Product Usage: Protection System and are intended to protect the patient, healthcare personnel and operating room personnel against contamination, exposure of infectious bodily fluids, and the transfer of microorganismsand particulate material. ","1010236, 1108682",".","2,000 units ( 200 boxes)","Based on an accelerated aging test for this product packaging, there is an indicator of potential for a breach in the sterile barrier in the header bag and potentially the blue sterilization wrap for togas within the second and third year of shelf life. The test method used involved high heat to accelerate the aging of the packaging. Stryker is conducting additional testing and assessing this product packaging while initiating this recall to reduce risk of patient harm related to the remote possibility of patient infection, if a breach in packaging were present.",5/23/2013,"05/23/2013",6/12/2013,"06/12/2013"
"Devices",65321,"Ongoing","Stryker Instruments Div. of Stryker Corporation","Portage","MI","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","USA Nationwide Distribution","Z-1504-2013","Class II","Stryker Instruments 0400-850-100 T5 zipper Toga with Peel Away, Sterile, EO; single use; Product Usage: Protection System and are intended to protect the patient, healthcare personnel and operating room personnel against contamination, exposure of infectious bodily fluids, and the transfer of microorganismsand particulate material. ","1006124, 1007164, 1010236, 1011296, 1103168, 1105341, and 1108634. ",".","6,990 units ( 699 boxes)","Based on an accelerated aging test for this product packaging, there is an indicator of potential for a breach in the sterile barrier in the header bag and potentially the blue sterilization wrap for togas within the second and third year of shelf life. The test method used involved high heat to accelerate the aging of the packaging. Stryker is conducting additional testing and assessing this product packaging while initiating this recall to reduce risk of patient harm related to the remote possibility of patient infection, if a breach in packaging were present.",5/23/2013,"05/23/2013",6/12/2013,"06/12/2013"
"Devices",65321,"Ongoing","Stryker Instruments Div. of Stryker Corporation","Portage","MI","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","USA Nationwide Distribution","Z-1490-2013","Class II","Stryker Instruments0400-720-000 T4 Pullover Toga (L/XL) Sterile, EO; single use; Product Usage: Protection System and are intended to protect the patient, healthcare personnel and operating room personnel against contamination, exposure of infectious bodily fluids, and the transfer of microorganismsand particulate material. ","1005105, 1010244, 1101004, 1104289, 1107568, 1005119, 1010261, 1101030, 1104324, 1108625, 1006129, 1011276, 1101047, 1105390, 1108672, 1006140, 1011296, 1102073, 1105355, 1109730, 1007151, 1012314, 1102127, 1106431, 1109782, 1007163, 1012337, 1102131, 1106467, 1109858, 1009213, 1012346, 1104253, 1107515. ",".","48,040 units, ( 4804 boxes)","Based on an accelerated aging test for this product packaging, there is an indicator of potential for a breach in the sterile barrier in the header bag and potentially the blue sterilization wrap for togas within the second and third year of shelf life. The test method used involved high heat to accelerate the aging of the packaging. Stryker is conducting additional testing and assessing this product packaging while initiating this recall to reduce risk of patient harm related to the remote possibility of patient infection, if a breach in packaging were present.",5/23/2013,"05/23/2013",6/12/2013,"06/12/2013"
"Devices",65321,"Ongoing","Stryker Instruments Div. of Stryker Corporation","Portage","MI","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","USA Nationwide Distribution","Z-1494-2013","Class II","Stryker Instruments 0400-770-000 T4 Toga, Pullover, Ex-Large Sterile, EO; single use; Product Usage: Protection System and are intended to protect the patient, healthcare personnel and operating room personnel against contamination, exposure of infectious bodily fluids, and the transfer of microorganismsand particulate material. ","1005105, 1009214, 1104308, 1006130, 1010260, 1104312, 1007152, 1012346, 1105378, 1007163, 1012303, 1106460, 1007164, 1101062, 1107542, 1008189, 1101063, 1108660, 1008188, 1102149, 1109760, 1009213, and 1103219.",".","21,660 units (2166 boxes)","Based on an accelerated aging test for this product packaging, there is an indicator of potential for a breach in the sterile barrier in the header bag and potentially the blue sterilization wrap for togas within the second and third year of shelf life. The test method used involved high heat to accelerate the aging of the packaging. Stryker is conducting additional testing and assessing this product packaging while initiating this recall to reduce risk of patient harm related to the remote possibility of patient infection, if a breach in packaging were present.",5/23/2013,"05/23/2013",6/12/2013,"06/12/2013"
"Devices",65321,"Ongoing","Stryker Instruments Div. of Stryker Corporation","Portage","MI","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","USA Nationwide Distribution","Z-1499-2013","Class II","Stryker Instruments 0400-820-100 T5 Zipper Toga with Peel Away, Sterile, O; single use; Product Usage: Protection System and are intended to protect the patient, healthcare personnel and operating room personnel against contamination, exposure of infectious bodily fluids, and the transfer of microorganismsand particulate material. ","1006130, 1101034, 1006134, 1102133, 1007151, 1103208, 1007170, 1104297, 1009205, 1105360, 1010228, 1106476, 1010260, 1107569, 1011296, 1108676, 1012336, 11097861006141, 1012303, 1102110, 1104324, and 1108664.",".","25,770 units (2,577 boxes)","Based on an accelerated aging test for this product packaging, there is an indicator of potential for a breach in the sterile barrier in the header bag and potentially the blue sterilization wrap for togas within the second and third year of shelf life. The test method used involved high heat to accelerate the aging of the packaging. Stryker is conducting additional testing and assessing this product packaging while initiating this recall to reduce risk of patient harm related to the remote possibility of patient infection, if a breach in packaging were present.",5/23/2013,"05/23/2013",6/12/2013,"06/12/2013"
"Devices",65321,"Ongoing","Stryker Instruments Div. of Stryker Corporation","Portage","MI","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","USA Nationwide Distribution","Z-1495-2013","Class II","Stryker Instruments 0400-810-000 T4 Zipper Toga (S/M) Sterile, EO; single use; Product Usage: Protection System and are intended to protect the patient, healthcare personnel and operating room personnel against contamination, exposure of infectious bodily fluids, and the transfer of microorganismsand particulate material. ","1006129, 1103201, 1009197, 1105391, 1009198, 1107548, 1012302, 1109788, and 1102127",".","7960 units (796 boxes)","Based on an accelerated aging test for this product packaging, there is an indicator of potential for a breach in the sterile barrier in the header bag and potentially the blue sterilization wrap for togas within the second and third year of shelf life. The test method used involved high heat to accelerate the aging of the packaging. Stryker is conducting additional testing and assessing this product packaging while initiating this recall to reduce risk of patient harm related to the remote possibility of patient infection, if a breach in packaging were present.",5/23/2013,"05/23/2013",6/12/2013,"06/12/2013"
"Devices",65321,"Ongoing","Stryker Instruments Div. of Stryker Corporation","Portage","MI","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","USA Nationwide Distribution","Z-1502-2013","Class II","Stryker Instruments 0400-850-000 T4 Toga, Zipper, (XL-Tall) Sterile, EO; single use; Product Usage: Protection System and are intended to protect the patient, healthcare personnel and operating room personnel against contamination, exposure of infectious bodily fluids, and the transfer of microorganismsand particulate material. ","1005097, 1008188, 1011281, 1103194, 1106465, 1107519, 1005105, 1008192, 1011296, 1103201, 1107501, 1109763, 1005111, 1009198, 1012303, 1103223, 1107550, 1109777, 1005118, 1009213, 1012314, 1104282, 1107560, 1109822, 1006129, 1009219, 1012325, 1104290, 1107605, 1109850, 1008181, 1009220, 1012335, 1104320, 1107606, 1006135, 1010228, 1012344, 1104312, 1108618, 1007145, 1010236, 1101003, 1105346, 1108663, 1007151, 1010235, 1101030, 1105355, 1108677, 1007156, 1010243, 1101055, 1105378, 1108709, 1007163, 1010252, 1102109, 1106411, 1108714, 1007169, 1010260, 1102123, 1105405, 1109728, 1008183, 1011276, 1102141, 1106430, and 1104275.",".","88,040 units (8,804 boxes)","Based on an accelerated aging test for this product packaging, there is an indicator of potential for a breach in the sterile barrier in the header bag and potentially the blue sterilization wrap for togas within the second and third year of shelf life. The test method used involved high heat to accelerate the aging of the packaging. Stryker is conducting additional testing and assessing this product packaging while initiating this recall to reduce risk of patient harm related to the remote possibility of patient infection, if a breach in packaging were present.",5/23/2013,"05/23/2013",6/12/2013,"06/12/2013"
"Devices",65321,"Ongoing","Stryker Instruments Div. of Stryker Corporation","Portage","MI","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","USA Nationwide Distribution","Z-1491-2013","Class II","Stryker Instruments 0400-720-000S5 T5 Pullover Toga w/Peel Away, Sterile, EO; single use. Product Usage: Protection System and are intended to protect the patient, healthcare personnel and operating room personnel against contamination, exposure of infectious bodily fluids, and the transfer of microorganismsand particulate material. ","1007157, 1103202",".","1,980 units (198 boxes)","Based on an accelerated aging test for this product packaging, there is an indicator of potential for a breach in the sterile barrier in the header bag and potentially the blue sterilization wrap for togas within the second and third year of shelf life. The test method used involved high heat to accelerate the aging of the packaging. Stryker is conducting additional testing and assessing this product packaging while initiating this recall to reduce risk of patient harm related to the remote possibility of patient infection, if a breach in packaging were present.",5/23/2013,"05/23/2013",6/12/2013,"06/12/2013"
"Devices",65322,"Ongoing","Becton Dickinson & Company","Franklin Lakes","NJ","US","Voluntary: Firm Initiated","Letter","Nationwide Distribution","Z-1923-2013","Class II","BD Vacutainer Multiple Sample and Direct Draw Luer Adapter BD Franklin Lakes, NJ 07417 USA A sterile non-invasive device used to connect venous access devices such as needles, blood collection sets, ad infusion sets to blood collection tubes.","Marketing Status: Class II, 510K # K991088 Device Listing Number: D030347 Catalog number 367290, 367300 (CE), 368491, and 303380.",".","37,906,400 units","BD Vacutainer Multiple Sample and Direct Draw Luer Adapter may have blood leakage and low draw volume.",5/1/2013,"05/01/2013",8/14/2013,"08/14/2013"
"Biologics",65323,"Terminated","Florida's Blood Centers - Lake Park","Palm Beach Gardens","FL","US","Voluntary: Firm Initiated","Letter","FL","B-2156-13","Class II","Red Blood Cells Leukocytes Reduced","W038113040525",".","1 unit","Blood product, collected from a donor who traveled to a malarial endemic area, was distributed. ",4/9/2013,"04/09/2013",9/11/2013,"09/11/2013"
"Drugs",65324,"Ongoing","Pfizer Inc","Peapack","NJ","US","Voluntary: Firm Initiated","Letter","Nationwide and Puerto Rico","D-607-2013","Class III","Norpace CR (disopyramide phosphate) extended-release capsules USP,150 mg, packaged in a) 100-count bottles (NDC 0025-2742-31), and b) 500-count bottles (NDC 0025-2742-51), Rx only, Distributed by G.D. Searle LLC, Division of Pfizer Inc, NY, NY 10017.","Lot #: a) C120138, Exp 07/13; b) C120137, Exp 07/13",,"5,410 botlles","Failed Dissolution Specification",5/31/2013,"05/31/2013",6/26/2013,"06/26/2013"
"Food",65325,"Ongoing","Contoocook Creamery","Contoocook","NH","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","NH only. No foreign distribution.","F-1859-2013","Class II","Butter (salted). 8oz round clear plastic tub and 5 gallon pail. UPC Code 7 93573 09802 3. ","N/A",".","quantity unknown","Elevated coliform and standard plate count. ",5/17/2013,"05/17/2013",9/11/2013,"09/11/2013"
"Food",65326,"Ongoing","Finger Lakes Farmstead Cheese Company Llc","Trumansburg","NY","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","1 firm in NY State.","F-1603-2013","Class I","Finger Lakes FARMSTEAD CHEESE Mecklenburg, NY Schuyler County, SCHUYLER Gouda aged at least 60 days, Net Wt. 8 lbs wheels. FINGER LAKES FARMSTEAD CHEESE CO. 5491 BERGEN ROAD TRUMANBURG, NY 14886. Ingredients: raw milk, rennet, calcium chloride, culures, salt","under investigation",".","5 wheels","Listeria monocytogenes contamination.",5/31/2013,"05/31/2013",7/17/2013,"07/17/2013"
"Food",65326,"Ongoing","Finger Lakes Farmstead Cheese Company Llc","Trumansburg","NY","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","1 firm in NY State.","F-1604-2013","Class II","Finger Lakes FARMSTEAD CHEESE Mecklenburg, NY Schyler County, BIER MECK Gouda, aged at least 60 days, Net Wt. 8 lbs wheels. FINGER LAKES FARMSTEAD CHEESE CO. 5491 BERGENT ROAD TRUMANBURG, NY Ingredients: raw milk, rennet, calcium chrloride, cultures, beer, salt","under investigation",".","7 wheels","Listeria monocytogenes contamination.",5/31/2013,"05/31/2013",7/17/2013,"07/17/2013"
"Food",65327,"Ongoing","ABCO Laboratories, Inc.","Fairfield","CA","US","Voluntary: Firm Initiated","Letter","CA and PA.","F-1585-2013","Class II","Soy Protein Isolate; 79 bulk raw material lots and 52 finished product lots. Soy Protein Isolate was sold in bulk to two customers, both sausage manufacturers not under FDA jurisdiction. Also sold 48 bags of 34.875 bags to a third sausage manufacturer. Finished product was made for Nurti-Cology - Allergy Research Group of Alameda, CA and Vinco Inc. of Evans City PA, both of whom will be conducting their own recalls."," All Lots 03-25-11 t0 05-21-13",".","52 lots of finished products, 70 bulk raw material lots.","ABCO products are being recalled as part of a larger recall from their supplier of certain soy based products produced in its Ashdod, Israel production facility.",5/24/2013,"05/24/2013",7/10/2013,"07/10/2013"
"Food",65327,"Ongoing","ABCO Laboratories, Inc.","Fairfield","CA","US","Voluntary: Firm Initiated","Letter","CA and PA.","F-1585-2013","Class II","Soy Protein Isolate; 79 bulk raw material lots and 52 finished product lots. Soy Protein Isolate was sold in bulk to two customers, both sausage manufacturers not under FDA jurisdiction. Also sold 48 bags of 34.875 bags to a third sausage manufacturer. Finished product was made for Nurti-Cology - Allergy Research Group of Alameda, CA and Vinco Inc. of Evans City PA, both of whom will be conducting their own recalls."," All Lots 03-25-11 t0 05-21-13",".","52 lots of finished products, 70 bulk raw material lots.","ABCO products are being recalled as part of a larger recall from their supplier of certain soy based products produced in its Ashdod, Israel production facility.",5/24/2013,"05/24/2013",7/17/2013,"07/17/2013"
"Devices",65328,"Ongoing","HeartWare Inc","Miami Lakes","FL","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution - USA including AL, AZ, CA, DC, DE, FL, GA, IA, IL, IN, KY, LA, MA, MD, MI, MN, MO, NC, NJ, NY, OH, OR, PA, TN, TX, UT, VA, WA, and WI. Internationally to: Australia, Austria, Belguim, Brazil, Canada, Chile, Croatia, Czech Republic, France, Germany, Greece, India, Israel, Italy, Japan, Lebanon, Lithuania, Luxemburg, Malaysia, Netherlands, New Zeland,Norway, Poland Singapore, South Africa, Switzerland, Turkey, and United Kingdom.","Z-1813-2013","Class II","HeartWare Ventricular Assist System For use as a bridge-to-cardiac transplantation in patients who are at risk of death from refractory end-stage left ventricular heart failure.","US product: Model 1400, 1401US, 1403US, 1404 International: Model 1400, 1401XX, 1407XX, 1408 ALL HEARTWARE CONTROLLER SERIAL NUMBERS",,"76 (US) and 82 (International)","Potential to electrostatic discharged (ESD)",5/16/2013,"05/16/2013",8/7/2013,"08/07/2013"
"Biologics",65329,"Terminated","Carter BloodCare","Bedford","TX","US","Voluntary: Firm Initiated","FAX","Switzerland, TX","B-2153-13","Class II","Red Blood Cells Leukocytes Reduced","W035213107399T",".","1 unit","Blood products, collected from a donor for whom donor suitability was not adequately determined, were distributed.",5/14/2013,"05/14/2013",9/11/2013,"09/11/2013"
"Biologics",65329,"Terminated","Carter BloodCare","Bedford","TX","US","Voluntary: Firm Initiated","FAX","Switzerland, TX","B-2154-13","Class III","Blood and Blood Products for Reprocessing","W035213107399T",".","1 unit","Blood products, collected from a donor for whom donor suitability was not adequately determined, were distributed.",5/14/2013,"05/14/2013",9/11/2013,"09/11/2013"
"Devices",65330,"Ongoing","Ethicon Endo-Surgery Inc","Cincinnati","OH","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution - US Nationwide all fifty states and including the countries of Canada, Belgium, India, Malaysia, Saudi Arabia, Brazil, Israel, Mexico, Singapore, Jordan, New Zealand, Taiwan, Chile, Korea, Puerto Rico, Turkey, Columbia, Kuwait, Qatar, United Arab Emirates, Egypt, Lebanon and Russia.","Z-1530-2013","Class II","ECHELON 60mm Endoscopic Linear Cutter Reloads Black in Flexible Blister pack with Tyvek lid. The ECHELON and ECHELON FLEX families of Endoscopic Linear Cutters (articulating and straight) are sterile, single patient use instruments that simultaneously cut and staple tissue. There are six staggered rows of staples, three on either side of the cut line. The ECHELON 60 instruments have a staple line that is approximately 60 mm long and a cut line that is approximately 57 mm long. The shaft can rotate freely in both directions and an articulation mechanism on articulating instruments enables bending the distal portion of the shaft to facilitate lateral access of the operative site. The instruments are shipped without a reload and must be loaded prior to use. A staple retaining cap on the reload protects the staple leg points during shipping and transportation. The instruments''' lock-out feature is designed to prevent a used reload from being refired.","The following lot numbers and associated expiration dates are affected by this recall: J4AY8Z 5/15/2013, J4C00J 6/15/2013, J4C87R 7/15/2013, J4CC1F 8/15/2013, J4CD2X 8/15/2013, J4CF3D 9/15/2013, J4CJ0E 9/15/2013, J4CJ78 9/15/2013, J4CK2P 9/15/2013, J4CM9X 10/15/2013, J4CR2H 10/15/2013, J4CT5H 11/15/2013, J4CU86 11/15/2013, J4CV1W 11/15/2013, J4CV5H 11/15/2013, K4C149 12/15/2013, K4C17W 12/15/2013, K4C33U 12/15/2013, K4C41C 12/15/2013, K4C600 1/15/2014, K4C64A 1/15/2014, 4C728 1/15/2014, K4C82K 1/15/2014, K4C88F 1/15/2014, K4C94W 1/15/2014, K4CC0L 2/15/2014, CC8L 2/15/2014, K4CD1E 2/15/2014, K4CF1P 2/15/2014, K4CF5D 2/15/2014, K4CG18 3/15/2014, K4CG4J 3/15/2014, K4CG8P 3/15/2014, K4CH44 3/15/2014, K4CK0W 3/15/2014, ",".","57,540 Units","Ethicon Endo-Surgery is initiating a voluntary worldwide recall for ECHELON 60mm Black Reload (ECR60T) due to the potential for incomplete staple line formation from reload damage during the firing sequence.",5/13/2013,"05/13/2013",6/19/2013,"06/19/2013"
"Devices",65331,"Terminated","Tecan US, Inc.","Morrisville","NC","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Worldwide distribution: US (nationwide) including states of: CA, KY, NC, OH, TX, and WI; and countries of: France, Germany and Italy.","Z-1560-2013","Class II","Tecan Freedom EVO with Touch Tools Suite Version 3.0 The intended use of the Touch Tools Suite is to run previously defined scripts and processes on a Freedom EVO platform (Touch Tools Suite is an optional software add-on for Freedom EVOware (the base operational software for the Freedom EVO 2 instrument. ","Instrument Freedom EVO 100 Base Unit: Material number: 10641100, Serial numbers: 1211001569, 1212000203 and 1212000205; Instrument Freedom EVO 100 MCA: Material number: 30020010, Serial number: 1301007643; Instrument Freedom EVO 150 Base Unit: Material number10641150, Serial number: 1301006708; Instrument Freedom EVO 150 MCA: Material number: 30020015, Serial number: 1211007442; Instrument Freedom EVO 150 MCA384: Material number: 30032015, Serial number: 1211011594 and 1109003270; Instrument Freedom EVO 200 Base Unit: Material number: 1641200, Serial number: 1106003923 and 1211011578 and Instrument Freedom EVO 200 MCA: Material number: 30020020, Serial number: 1208007288 and 1208007284. ",,"12 units","WIth TouchTools 3.0 after the execution of a Rich User Prompt in Display and Wait mode, door lock errors are ignored. If an operator presses ''Continue'' following a Rich User Prompt and the door has been left open, the script will progress (continue without warning). This could lead to the instrument moving unexpectedly and potentially cause an injury to the operator if they are physically inside the Freedom EVO's working area.",2/19/2013,"02/19/2013",6/26/2013,"06/26/2013"
"Devices",65332,"Ongoing","Fresenius Medical Care Holdings, Inc.","Waltham","MA","US","Voluntary: Firm Initiated","Letter","Nationwide Distribution","Z-1674-2013","Class II","Fresenius Liberty Cycler Set Single Conn./Ext DL Product Number: 050-87216 Automated Peritoneal Dialysis System with integrated stay safe patient connector and extended drain line. ","Lot 11PR08083",".","5480 units","Cassette may leak during set up or during peritoneal dialysis treatment",6/3/2013,"06/03/2013",7/17/2013,"07/17/2013"
"Devices",65333,"Completed","GE Healthcare, LLC","Waukesha","WI","US","Voluntary: Firm Initiated","Visit","Worldwide distribution: US (nationwide) including states of: AL, AZ, CA, CT, FL, GA, HI, IL, IN, IA, KY,ME, MD,MA, MI,MN, MS, NV, NH, NJ, NY, NC, PA, TN, TX, VA, WA,WV, and WI; and countries of: AUSTRALIA, BELGIUM, BRAZIL, CANDA, CHINA, DENMARK, FINLAND, FRANCE, GERMANY, GREECE, HONG KONG, INDIA, INDONESIA, IRELAND, ISRAEL, ITALY, JAPAN,JORDAN, REPUBLIC OF KOREA, KUWAIT, LATVIA, NEW ZEALAND, POLAND, RUSSIAN FEDERATION, SAUDI ARABIA, SINGAPORE, SOUTH AFRICA, SWEDEN, SWITZERLAND, TUKEY, and UNITED KINGDOM.","Z-1940-2013","Class II","GE LightSpeed CT750 HD The GE LightSpeed CT750 HD Computed Tomography X-ray system is intended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission data taken at different angles and planes, including Axial, Cine, Helical (Volumetric), Cardiac, Spectral, and Gated acquisitions for all ages.","GSI Viewer on CT750HD CT Systems Software Update to 10MW25.6 Serial# 00000409809CN1 00000421170CN2 00000409525CN3 00000410002CN0 00000408483CN6 00000406075CN2 00000404225CN5 00000405725CN3 00000408128CN7 00000409481CN9 00000408280CN6 00000419816CN4 00000408127CN9 00000408230CN1 00000409450CN4 00000412501CN9 00000411125CN8 00000409344CN9 00000409145CN0 00000412398CN0 00000409881CN0 00000413835CN0 00000413765CN9 00000411126CN6 00000412015CN0 00000412399CN8 00000411349CN4 00000411611CN7 00000414853CN2 00000415105CN6 00000416839CN9 00000416410CN9 00000409806CN7 00000414686CN6 00000420612CN4 00000421374CN0 00000411613CN3 00000415502CN4 00000412042CN4 00000414971CN2 00000413841CN8 00000413362CN5 00000413566CN1 00000420173CN7 00000412503CN5 00000415396CN1 00000415826CN7 00000421147CN0 00000414851CN6 00000415104CN9 00000419891CN7 00000420174CN5 00000414852CN4 00000414973CN8 00000416765CN6 00000418112CN9 00000418335CN6 00000420610CN8 00000416669CN0 00000415439CN9 00000416628CN6 00000417737CN4 00000415469CN6 00000417465CN2 00000419582CN2 00000421590CN1 00000418155CN8 00000417172CN4 00000418484CN2 00000419819CN8 00000418156CN6 00000421378CN1 00000419107CN8 00000422266CN7 00000421121CN5 00000419817CN2 00000422267CN5 00000411391CN6 00000416872CN0 00000417476CN9 00000419135CN9 00000419447CN8 00000408673CN2 00000411348CN6 00000409754CN9 00000409805CN9 00000412738CN7 00000416033CN9 00000416779CN7 00000416974CN4 00000417373CN8 00000409751CN5 00000409343CN1 00000409755CN6 00000409807CN5 00000409753CN1 00000417769CN7 00000414972CN0 00000415092CN6 00000414879CN7 00000416546CN0 00000416122CN0 00000416037CN0 00000419954CN3 00000418659CN9 00000416943CN9 00000417766CN3 00000409879CN4 00000415358CN1 00000413323CN7 00000415204CN7 00000415203CN9 00000417806CN7 00000415448CN0 00000415240CN1 00000414058CN8 00000417618CN6 00000416588CN2 00000416366CN3 00000416545CN2 00000417422CN3 00000418021CN2 00000418154CN1 000004",,"244","GE Healthcare conducted a recall involving 2 events affecting the GE LightSpeed CT750 HD. Event 1 - There was a report regarding CT number variance in time line at posterior fossa region of head perfusion. When beam hardening and helical artifacts in this region are reconstructed into the perfusion map, these artifacts will give subtle differences in the CT numbers. Event 2 - The software does not flip S DICOM coordinates when it fills in the DICOM header for tilted images using the Recon Flip/Rotate top-bottom flip (FTB). The images created are stored with an incorrect coordinate value, which incorrectly puts the image in the wrong plane causing the image coordinates annotated on a viewer to be incorrect.",4/5/2011,"04/05/2011",8/21/2013,"08/21/2013"
"Drugs",65334,"Ongoing","Actavis","Salt Lake City","UT","US","Voluntary: Firm Initiated","Letter","Nationwide","D-599-2013","Class III","Fentanyl Transdermal System, 50 mcg/h, 1 system per pouch (NDC 0591-3212-54), packaged in 5-count systems per box (NDC 0591-3212-72), Rx only, Manufactured by Watson Laboratories, Inc, Corona, CA, 92880 USA; Distributed by: Watson Pharma, Inc.","Lot #: Patch 453658; Carton 453658A, Exp 09/13",".","98,952 boxes","Failed Impurities/Degradation Specifications",6/3/2013,"06/03/2013",6/19/2013,"06/19/2013"
"Food",65335,"Ongoing","International Desserts and Delicacies","Glendale","CA","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Nationwide to retail grocery stores.","F-1525-2013","Class I","Uncle Eddies Vegan Oatmeal Chocolate Cookies, 12 oz. One shipping carton/case consists of 12bags. Product labeling reads in part:''uncle Eddies vegan oatmeal chocolate-chip cookies***net wt. 12 oz (340g)***MFG BY:INTERNATIONAL DESSERTS GLENDALE, CA 91203***(818) 549-0056***www.vegancookies.com***''. "," Lot numbers #110813, and #58513 ",".","540 bags","International Desserts of Glendale, California is recalling Uncle Eddies Vegan Oatmeal Chocolate Cookies in 12 oz bags, because it may contain undeclared walnuts. ",5/31/2013,"05/31/2013",6/19/2013,"06/19/2013"
"Biologics",65336,"Completed","Data Innovations, Inc.","South Burlington","VT","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Nationwide.","B-2265-13","Class II","Data Innovations Instrument Manager Software Any version of Instrument Manager using the Roche Cobas e411 (rche411) driver versions 8.00.0001 or v8.00.002"," Roche Cobas e411 (rche411) driver versions 8.00.0001 or v8.00.002",".","1","Laboratory software, with a defect or glitch, was distributed. ",1/2/2013,"01/02/2013",9/11/2013,"09/11/2013"
"Devices",65337,"Ongoing","Stryker Medical Division of Stryker Corporation","Portage","MI","US","Voluntary: Firm Initiated","Letter","Nationwide Distribution-USA including the states of OH, ME, IL, CO , FL, TX, MI, GA, and VA.","Z-1946-2013","Class II","IsoGel AIR 84, Support Surface. Intended to assist in improving human patient outcomes. ","Model Numbers: 2860-000-001 and 2860-000-002 and serial numbers: 121228600100355, 121228600100356, 121228600100357, 121228600200315, 121228600200316 121228600200322, 121228600200323, 121228600200324, 121228600200325, 121228600200326 121228600200332, 121228600200333, 121228600200334, 121228600200335, 121228600200336 121228600200342, 121228600200343, 121228600200344, 121228600200345, 121228600200346 121228600200352, 121228600200353, 121228600200367, 121228600200368, 121228600200369 121228600200375, 121228600200376, 121228600200377, 121228600200378, 121228600200379 121228600200386, 121228600200393, 121228600200394, 121228600200395, 121228600200396 121228600200402, 121228600200403, 121228600200404, 121228600200405, 011328600100406 011328600100412, 011328600100413, 011328600100414, 011328600100415, 011328600100416 011328600100422, 011328600100423, 011328600100424, 011328600100425, 011328600100426 011328600100432, 011328600100433, 011328600100434, 011328600100435, 011328600100436 011328600100442, 011328600100443, 011328600100444, 011328600100445, 011328600100446 011328600100452, 011328600100453, 011328600100454, 011328600100455, 011328600100456 011328600100462, 011328600100463, 011328600100464, 011328600100465, 011328600100466 011328600100474, 011328600100475, 011328600100476, 011328600100477, 011328600100478 011328600100492, 011328600100493, 011328600100494, 011328600100495, 011328600100497 011328600100611, 011328600100612, 011328600100615, 011328600100617, 011328600100618 011328600100625, 011328600100626, 011328600100629, 011328600100630, 011328600100631 011328600100637, 011328600100638, 011328600100639, 011328600100640, 011328600100641 011328600100647, 011328600100648, 011328600100649, 011328600100650, 011328600100651 011328600100657, 011328600100658, 011328600100659, 011328600100660, 011328600100661 011328600100667, 011328600100668, 011328600100669, 011328600100670, 011328600100671 011328600100677, 011328600100678, 011328600100679, 011328600100680, 011328600100681 011328600100687, 011328600100688, 01132860010068",,"586 units","Complaints were received from the field indicating that some Air Pumps were flashing and alarming when connected to the IsoGel AIR'' surface upon turning the pump on and the setting it to the IsoGel AIR Mode. Upon further investigation, it was determined that the flashing/alarm being experienced was due to the air pressure being out of the expected range; indicating a blockage within the LAL tubing subassembly. All IsoGel AIR'' Support Surfaces come equipped with integrated Low Air Loss (LAL) tubing. Low Air Loss functionality is available only if the surface is connected to the optional Stryker Air Pump.",7/12/2013,"07/12/2013",8/21/2013,"08/21/2013"
"Drugs",65338,"Ongoing","Actavis South Atlantic LLC","Sunrise","FL","US","Voluntary: Firm Initiated","Letter","Nationwide","D-829-2013","Class II","Ranitidine Syrup (Ranitidine Oral Solution USP) 15 mg/mL, Rx Only. Manufactured by VistaPharm, Inc., Birmingham, AL 35242. Distributed by Actavis Mid Atlantic LLC 1877 Kawai Road, Lincolnton, NC 28092 USA","Lot Numbers: 247900, 251000, 256000, 261200, 263600, 266700, 277100, 280300 and 284300.",,"A total of 133,968 bottles (units)","Failed Impurity/Degradation Specification; ''Related Compound C'' ",5/15/2013,"05/15/2013",8/7/2013,"08/07/2013"
"Drugs",65339,"Ongoing","Sagent Pharmaceuticals Inc","Schaumburg","IL","US","Voluntary: Firm Initiated","Letter","Nationwide and Puerto Rico","D-605-2013","Class II","VECURONIUM Bromide for Injection, 10 mg* per vial, *1 mg per mL when reconstituted to 10 mL, for IV single use only, Rx only, Mfd. for SAGENT Pharmaceuticals, Schaumburg, IL 60195 (USA); Mfd. by MN Pharmaceuticals; Made in Turkey, NDC 25021-657-10.","Lot #s: 11F23921A, 11G24001A, 11G24251A, 11G24471A, 11G24701A, 11G25051A, 11G25471A, 11G24341A, Exp 07/13; 11I30521A, 11I31651A, 11I31661A, 11I30481A, 11I30721A, 11I30731A, Exp 09/13; 11I32581A, 11K34241A, 11K34471A, 11K35861A, 11K36761A, 11K37451A, 11K37471A, 11K38171A, Exp 10/13; 11L40161A, 11L40201A, 11L40891A, 11L40781A, 11L40851A, 11L40921A, 11L42961A, Exp 11/13; 11M44271A, 11M44371A, 11M44381A, 11M45041A, 11M45421A, 11M45641A, Exp 12/13; 12A02161A, Exp 01/14; 12B04871A, 12B04921A, 12B06501A, 12B06741A, Exp 02/14; 12C09031A, 12C09041A, 12C09301A, 12C09461A, 12C09471A, 12C11641A, Exp 03/14; 12D12401A, 12D12761A, 12D12861A, 12D13061A, 12D13351A, 12D13361A, 12D13401A, Exp 04/14; 12E15981A, Exp 05/14",,"831,950 vials","CGMP Deviations: product was not manufactured under current good manufacturing practices which contributed to Failed Impurities/Degradation Specifications as a high out of specification impurity result was detected during routine quality testing of stability samples.",6/7/2013,"06/07/2013",6/26/2013,"06/26/2013"
"Biologics",65340,"Completed","Data Innovations, Inc.","South Burlington","VT","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Nationwide; Canada","B-2299-13","Class II","Data Innovations Instrument Manager software Model - Versions 8.12.01 ","Software Version: 8.12.01",".","1","Laboratory software, with a defect or glitch, was distributed. ",9/14/2012,"09/14/2012",9/11/2013,"09/11/2013"
"Devices",65341,"Ongoing","International Biomedical, Ltd.","Austin","TX","US","Voluntary: Firm Initiated","Letter","Nationwide Distribution.","Z-1531-2013","Class II","VIA Medical Collection Bag; The collection bag is an accessory waste bag used in conjunction with the sterile LVM blood gas sensor with the LVM Monitor. The collection bag is packaged in a tyvek pouch which is included in either replacement kit (777-3103) or LVM sensor kit (777-3102).","Model/Part Number: 209-2113, or as part of kits 777-3103 and 777-3102. Collection Bag Lot numbers: 4389, 4465, 4478, 4516, 4530, 4430, 4489",".","7,000","International Biomedical has received reports of interference between the collection bag and the extension set connectors. Evaluation of the affected components indicates that the collection bag connector can become occluded due to an over-tightening of the luer lock by the end user. To alleviate the occurrence of this issue in the fixture, the connector on the collection bag has been improved to assure a tight seal while not allowing the component to be overtightened to the extent where an occlusion would occur. ",5/24/2013,"05/24/2013",6/19/2013,"06/19/2013"
"Devices",65342,"Ongoing","Medtronic Neuromodulation","Minneapolis","MN","US","Voluntary: Firm Initiated","Letter","Worldwide distribution: US (nationwide) and countries of: Aruba, Australia, Austria, Belgium, Canada, Chile, China, Colombia, Costa Rica, Cyprus, Czech Republic, Denmark, Dominican Republic, Ecuador, Finland, France, Georgia, Germany, Greece, Guadeloupe, Hong Kong, Hungary, Iceland, India, Ireland, Israel, Italy, Jordan, Korea, Kuwait, Lebanon, Lithuania, Luxembourg, Malta, Martinique, Morocco, Netherlands, Netherlands Antilles, New Zealand, Norway, Panama, Poland, Portugal, Puerto Rico, Qatar, Romania, Russian Federation, San Marino, Saudi Arabia, Singapore, Slovakia, Slovenia, South Africa, Spain, Sri Lanka, Sweden, Switzerland, Thailand, Trinidad and Tobago, Turkey, United Arab Emirates, United Kingdom, Uruguay, and Venezuela.","Z-1576-2013","Class I","Medtronic Intrathecal Catheter, model 8731SC. Contents: 38.1-cm spinal segment with length markings and guide wire, 66-cm pump segment, 15 T-gauge introducer needle, Transparent Strain-relief sleeves, Opaque Strain-relief sleeves, and V-wing anchors. Contents of inner package are STERILE. The implantable Medtronic Model 8731SC Intrathecal Catheter is part of an infusion system that stores and delivers parenteral drugs to the intrathecal space. The implanted infusion system components consist of a Medtronic pump and a Model 8731SC catheter. The catheter connects to the pump at the catheter port. ","Product having a Use By Date prior to 25 Aug 2014",,"115,722 total","The Sutureless Connector (SC) Intrathecal Catheter connector has been redesigned to reduce the potential for occlusion at the catheter to pump interface. Medtronic is removing the unused products from the market that were manufactured with the previous design, and recommend the previous design no longer be used due to greater potential for misalignment and subsequent occlusion.",6/3/2013,"06/03/2013",7/3/2013,"07/03/2013"
"Devices",65342,"Ongoing","Medtronic Neuromodulation","Minneapolis","MN","US","Voluntary: Firm Initiated","Letter","Worldwide distribution: US (nationwide) and countries of: Aruba, Australia, Austria, Belgium, Canada, Chile, China, Colombia, Costa Rica, Cyprus, Czech Republic, Denmark, Dominican Republic, Ecuador, Finland, France, Georgia, Germany, Greece, Guadeloupe, Hong Kong, Hungary, Iceland, India, Ireland, Israel, Italy, Jordan, Korea, Kuwait, Lebanon, Lithuania, Luxembourg, Malta, Martinique, Morocco, Netherlands, Netherlands Antilles, New Zealand, Norway, Panama, Poland, Portugal, Puerto Rico, Qatar, Romania, Russian Federation, San Marino, Saudi Arabia, Singapore, Slovakia, Slovenia, South Africa, Spain, Sri Lanka, Sweden, Switzerland, Thailand, Trinidad and Tobago, Turkey, United Arab Emirates, United Kingdom, Uruguay, and Venezuela.","Z-1575-2013","Class I","Medtronic INDURA 1P Intrathecal Catheter, model 8709SC. Contents: 81.4-cm catheter with length markers and guide wire, 15 T-gauge introducer needle, Sutureless pump connector with attached 7.6-cm catheter and Connector pin, Transparent Strain-relief sleeves, and anchors. Contents of inner package are STERILE. The implantable Medtronic INDURA 1P Model 8709SC Intrathecal Catheter is part of an infusion system that stores and delivers parenteral drugs to the intrathecal space. The implanted infusion system components consist of a Medtronic pump and a Model 8709SC catheter. The catheter connects to the pump at the catheter port. ","Product having a Use By Date prior to 25 Aug 2014",,"115,7422 total","The Sutureless Connector (SC) Intrathecal Catheter connector has been redesigned to reduce the potential for occlusion at the catheter to pump interface. Medtronic is removing the unused products from the market that were manufactured with the previous design, and recommend the previous design no longer be used due to greater potential for misalignment and subsequent occlusion.",6/3/2013,"06/03/2013",7/3/2013,"07/03/2013"
"Devices",65342,"Ongoing","Medtronic Neuromodulation","Minneapolis","MN","US","Voluntary: Firm Initiated","Letter","Worldwide distribution: US (nationwide) and countries of: Aruba, Australia, Austria, Belgium, Canada, Chile, China, Colombia, Costa Rica, Cyprus, Czech Republic, Denmark, Dominican Republic, Ecuador, Finland, France, Georgia, Germany, Greece, Guadeloupe, Hong Kong, Hungary, Iceland, India, Ireland, Israel, Italy, Jordan, Korea, Kuwait, Lebanon, Lithuania, Luxembourg, Malta, Martinique, Morocco, Netherlands, Netherlands Antilles, New Zealand, Norway, Panama, Poland, Portugal, Puerto Rico, Qatar, Romania, Russian Federation, San Marino, Saudi Arabia, Singapore, Slovakia, Slovenia, South Africa, Spain, Sri Lanka, Sweden, Switzerland, Thailand, Trinidad and Tobago, Turkey, United Arab Emirates, United Kingdom, Uruguay, and Venezuela.","Z-1573-2013","Class I","Medtronic Sutureless Pump Connector Revision Kit, model 8578. Contents: catheter interface with attached sutureless pump connector, catheter, connector pin, and strain-relief sleeve to be used with Medtronic SynchroMed implantable drug infusion pumps. Contents of inner package are STERILE. The Medtronic Model 8578 Sutureless Pump Connector Revision Kit is used when a pump connector for an Indura 1P Model 8709 or Model 8709SC catheter is required. The catheter is part of an infusion system that stores and delivers parenteral drugs to the intrathecal space. The implanted infusion system components consist of a Medtronic pump and an Indura 1P Model 8709 or Model 8709SC catheter. The catheter connects to the pump with the Model 8578 sutureless pump connector at the catheter port. ","Product having a Use By Date prior to 25 Aug 2014",,"115,722 total","The Sutureless Connector (SC) Intrathecal Catheter connector has been redesigned to reduce the potential for occlusion at the catheter to pump interface. Medtronic is removing the unused products from the market that were manufactured with the previous design, and recommend the previous design no longer be used due to greater potential for misalignment and subsequent occlusion.",6/3/2013,"06/03/2013",7/3/2013,"07/03/2013"
"Devices",65342,"Ongoing","Medtronic Neuromodulation","Minneapolis","MN","US","Voluntary: Firm Initiated","Letter","Worldwide distribution: US (nationwide) and countries of: Aruba, Australia, Austria, Belgium, Canada, Chile, China, Colombia, Costa Rica, Cyprus, Czech Republic, Denmark, Dominican Republic, Ecuador, Finland, France, Georgia, Germany, Greece, Guadeloupe, Hong Kong, Hungary, Iceland, India, Ireland, Israel, Italy, Jordan, Korea, Kuwait, Lebanon, Lithuania, Luxembourg, Malta, Martinique, Morocco, Netherlands, Netherlands Antilles, New Zealand, Norway, Panama, Poland, Portugal, Puerto Rico, Qatar, Romania, Russian Federation, San Marino, Saudi Arabia, Singapore, Slovakia, Slovenia, South Africa, Spain, Sri Lanka, Sweden, Switzerland, Thailand, Trinidad and Tobago, Turkey, United Arab Emirates, United Kingdom, Uruguay, and Venezuela.","Z-1574-2013","Class I","Medtronic Intrathecal Catheter Pump Segment Revision Kit, model 8596SC. Contents: 60-cm pump segment with attached sutureless pump connector, Spinal Segment Strain-relief sleeves, Pump segment strain-relief sleeves, Connector pin. Contents of inner package are STERILE. The Medtronic Model 8596SC Pump Segment Revision Kit is used when a revision to the pump segment of the Model 8731 or Model 8731SC catheter is required. The catheter is part of an infusion system that stores and delivers parenteral drugs to the intrathecal space. The implanted infusion system components consist of a Medtronic pump and a Model 8731 or Model 8731SC catheter. The catheter connects to the pump at the catheter port. ","Product having a Use By Date prior to 25 Aug 2014",,"115,722 total","The Sutureless Connector (SC) Intrathecal Catheter connector has been redesigned to reduce the potential for occlusion at the catheter to pump interface. Medtronic is removing the unused products from the market that were manufactured with the previous design, and recommend the previous design no longer be used due to greater potential for misalignment and subsequent occlusion.",6/3/2013,"06/03/2013",7/3/2013,"07/03/2013"
"Devices",65343,"Ongoing","Loma Vista Medical","Burlingame","CA","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution-US Distribution in New Jersey and the countries of Germany, Switzerland, Italy, Norway, The Netherlands, Spain, Portugal, Ireland, and Austria.","Z-1566-2013","Class II","TRUE Dilatation Balloon Valvuloplasty Catheter, REF Numbers: 02045-11, 02245-12, 02445-12, and 02645-13; Sizes: 20mm x 4.5cm, 22mm x 4.5cm, 24mm x 4.5cm, and 26mm x 4.5cm; Intended to be used for balloon aortic valvuloplasty.","All lot numbers lower than PLN00749 are subject to this recall.",,"2379 units","Slow deflation time: Slower than normal balloon deflation time of greater than 10 seconds. The balloon normally deflates in less than 5 seconds. The device performance specification for deflation time is 10 seconds maximum.",3/18/2013,"03/18/2013",7/3/2013,"07/03/2013"
"Biologics",65344,"Terminated","Blood Centers of the Pacific - Irwin Center","San Francisco","CA","US","Voluntary: Firm Initiated","Telephone","California","B-2075-13","Class II","Red Blood Cells Leukocytes Reduced","W117013227633; ",,"1","Blood product, collected from a donor who reported travel to a malarial endemic area, was distributed. ",5/8/2013,"05/08/2013",9/4/2013,"09/04/2013"
"Biologics",65345,"Terminated","OneBlood / dba CBCF","Lauderhill","FL","US","Voluntary: Firm Initiated","Letter","Florida","B-2229-13","Class II","Red Blood Cells","2466267; 1748931; ",".","2 units","Blood products, collected from an inelgible donor, were distributed. ",5/3/2013,"05/03/2013",9/11/2013,"09/11/2013"
"Biologics",65345,"Terminated","OneBlood / dba CBCF","Lauderhill","FL","US","Voluntary: Firm Initiated","Letter","Florida","B-2227-13","Class II","Platelets Pooled Leukocytes Reduced","W036812845514; ",".","1 unit","Blood products, collected from an inelgible donor, were distributed. ",5/3/2013,"05/03/2013",9/11/2013,"09/11/2013"
"Biologics",65345,"Terminated","OneBlood / dba CBCF","Lauderhill","FL","US","Voluntary: Firm Initiated","Letter","Florida","B-2228-13","Class III","Blood and Blood Products for Reprocessing","W036812575466; ",".","1 unit","Blood products, collected from an inelgible donor, were distributed. ",5/3/2013,"05/03/2013",9/11/2013,"09/11/2013"
"Biologics",65345,"Terminated","OneBlood / dba CBCF","Lauderhill","FL","US","Voluntary: Firm Initiated","Letter","Florida","B-2226-13","Class II","Red Blood Cells Leukocytes Reduced","W036812575466; ",".","1 unit","Blood products, collected from an inelgible donor, were distributed. ",5/3/2013,"05/03/2013",9/11/2013,"09/11/2013"
"Biologics",65346,"Terminated","OneBlood, Inc.","Hialeah","FL","US","Voluntary: Firm Initiated","Letter","Florida","B-2231-13","Class II","Platelets Pooled Leukocytes Reduced","2922847; ",".","1 unit","Blood products, collected from an inelgibile donor, were distributed. ",5/2/2013,"05/02/2013",9/11/2013,"09/11/2013"
"Biologics",65346,"Terminated","OneBlood, Inc.","Hialeah","FL","US","Voluntary: Firm Initiated","Letter","Florida","B-2232-13","Class II","Red Blood Cells","2565869; 2514057; ",".","2 units","Blood products, collected from an inelgibile donor, were distributed. ",5/2/2013,"05/02/2013",9/11/2013,"09/11/2013"
"Biologics",65346,"Terminated","OneBlood, Inc.","Hialeah","FL","US","Voluntary: Firm Initiated","Letter","Florida","B-2230-13","Class II","Fresh Frozen Plasma","2565869; ",".","1 unit","Blood products, collected from an inelgibile donor, were distributed. ",5/2/2013,"05/02/2013",9/11/2013,"09/11/2013"
"Devices",65347,"Ongoing","Boston Scientific Corporation","Marlborough","MA","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution - USA Nationwide including the state of NY, NE, MD, OH, TX, PA, VA, PR, CA, NJ, NY, CA and the countries of: AT, FR, DE, GB, IL, IT, LB, NL, ES, SE, TN, Argentina, and Japan.","Z-1671-2013","Class III","RigiflexTM 11 Single-Use Achalasia Balloon Dilator, Material Number (UPN) M00554510 Product Usage: The Boston Scientific Corporation RigiflexTM II Single- Use Achalasia Balloon Dilator is indicated for dilatation of the cardia in patients with achalasia. ","Lot/Batch Number: 091541",".","91 ","Product labeled with incorrect expiration date. ",5/28/2013,"05/28/2013",7/17/2013,"07/17/2013"
"Devices",65348,"Ongoing","Invacare Corporation","Elyria","OH","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution - USA including AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV, and WY. Internationally to Canada, Australia, Bermuda, Brazil, China, Costa Rica, Germany, France, United Kingdom, Guam, Hong Kong, Israel, India, Kuwait, New Zealand, Puerto rico, Qatar, Saudi Arabia, Singapore, Thailand, Trinidad, Tobago, and South Africa.","Z-2270-2013","Class II","Invacare Power Wheelchair, one per box To provide mobility to a person restricted to a sitting position.","The following Joystick model numbers and respective part numbers are affected by this recall: CSPJ, 1121239; SPJPLUS, 1127291; SPJAP, 1136937; SPJAPM, 1136938; CMPJM6, 1164361; CMPM6U, 1644361; MPJM6, 1136885; MPJM6U, 1136885; 1558M6, 1136887; 1558MM6, 1136887; 1500M6, 1136889; PACM6, 1136888; PACM6, 1167927; PSRM6, 1139941; PSRM6, 1140046; PSRM6, 1140047; PSRM6, 1140048; PSRM6, 1144844; PSRM6, 1144845; and PSFM6, 1139944. The following Power Wheelchair model numbers (affected date ranges are included in the 1525712 6-3-13 001C model numbers FINAL xlsx document) are affected by this recall: M61UKRD; 3GAR; 3GARBASE; 3GAR-CG; 3GRX; 3GRXBASE; 3GRX-CG; 3GSEAT-CG; 3GSTRX-TS; 3GTQ3; 3GTQ3-CG; 3GTQ3-MCG; 3GTQ3V; 3GTQ-CG; 3GTQ-MCG; 3GTQSE; 3GTQSEBASE; 3GTQSE-CG; 3GTQSE-PTO; 3GTQSP; 3GTQSPBASE; 3GTQSP-TS; FDX; FDX-CG; FDX-MCG; M41BB; M41RB; M41RBCN; M51 PBLUEBASE; M51 PREDBASE; M51BB; M51-CG; M51CGBB; M51CGRB; M51P; M51PBB; M51PBLUEBASE; M51PR; M51PRB; M51PREDBASE; M51RB; M51RBCN; M51SEAT-CG; M61; M61 PBLUE; M61 PRED ; M61 ; KRDBASE; M61(1144227); M61FBLUE; M61FRAD; M61FRED; M61R; M61RB(1144227); M61RBCN; M61RED; M61SEAT; M61UK; M61UK REDBASE; M61UKRD; M61UKRDBASE; M71; M71JR; M71R; M71SEAT; M71-TS; M91; M91-C; M91-M; M91R; M91-R; M91SEAT; M91-TS; M94; M94-C; PTBASE; PTORB; PWORBITS; R51; R51LXP; TDX3; TDX3BASE; TDX3-PS; TDX3SE; TDX3SEBASE; TDX3SE-PS; TDX3SE-TS; TDX3-TS; TDX4; TDX4BASE; TDX4-PS; TDX4-TS; TDX5; TDX5BASE; TDX5-PS; TDX5-TS; TDXSC; TDXSC2-CG; TDXSCSEAT; TDXSCV; TDXSEAT; TDXSI; TDXSI-2; TDXSI-2-S; TDXSI-CG; TDXSI-HD; TDXSI-HD-S; TDXSISEAT; TDXSISEAT-HD; TDXSIV; TDXSIV-2; TDXSIV-2-S; TDXSIV-HD; TDXSIV-HD-S; TDXSP; TDXSPBASE; TDXSP-CG; TDXSP-CG-GT; TDXSP-GT; TDXSP-MCG; TDXSP-MCG-GT; TDXSPREE; TDXSPREE-CG; TDXSPREESEAT; TDXSPSEAT; TDXSR; TDXSR-CG; TDXSR-CG-HD; TDXSR-HD; TDXSR-MCG; TDXSR-MCG-HD; TDXSRSEAT; TDXSRV; and TDXSRV-HD. ",".","166,230","Unintended slowing or deceleration, and on rare occasion, unanticipated and unattended acceleration of power wheelchairs equipped with SPJ and MPJ type joysticks.",6/4/2013,"06/04/2013",10/2/2013,"10/02/2013"
"Drugs",65349,"Ongoing","Faria Limited LLC dba Sheffield Pharmaceuticals","New London","CT","US","Voluntary: Firm Initiated","Letter","PA, GA, WA, CA","D-604-2013","Class III","Dr. Sheffield's Triple Antibiotic Ointment Bacitracin 400 units, Neomycin Sulfate 3.5mg, Polymyxin-B Sulfate 5,000 units, First Aid Antibiotic Ointment, Net Wt. 0.33oz (9g)","Lot # 10301, Exp 05/14 Lot # 10302, Exp 05/14",,"105,744 tubes","Failed Stability Specifications: Unable to meet shelf life expiry.",5/28/2013,"05/28/2013",6/26/2013,"06/26/2013"
"Veterinary",65350,"Completed","Ridley Block Operations, Inc.","Mankato","MN","US","Voluntary: Firm Initiated","Telephone","One game Farm in SD","V-007-2014","Class I","WAT Partridge Grower, AVT133, Product No. 37465. Medicated Complete Partridge Grower. Active Drug Ingredient: Lasalocid 113 g/ton. Hubbard Feeds, Inc. General Offices, Mankato, MN 56002-8500","Batch number B00578501",".","7,760 lbs.","The one customer complained that after feeding the bird chicks for a few days he noticed they were not eating. Additionally, approximately 150 bird chicks died from the pen of 1,500 at the game farm.",5/23/2013,"05/23/2013",12/4/2013,"12/04/2013"
"Food",65351,"Ongoing","American Importing Co, Inc","Minneapolis","MN","US","Voluntary: Firm Initiated","Telephone","One main customer, Target Corporation with 52 distribution locations. AL, AZ, CA, CO, GA, IL, IN, IA, KS, MI, MN, NY, NC, OH, OR, PA SC, TX, VA, WI.","F-1529-2013","Class II","Market Pantry, Sweet & Salty Mix, NET WT 3 oz (85g), UPC 0 85239 08131 0, INGREDIENTS: Peanuts (peanuts...) ...Honey Roasted Peanuts...Honey Roasted Soy Nuts(soybeans...)., CONTAINS PEANUTS AND SOY, May contain tree nuts, milk, wheat and eggs. Distributed by Target Corporation, Minneapolis, MN 55403. "," 074X348, 092X348, 105X348, 106X348, 107X348, 108X348, 109X348, 112X348, 120X348, 121X348, 122X348.",".","2869 cases (24 cups per case)","American Importing Co, Inc is recalling Market Pantry Sweet & Salty Mix because it contains Butter Toffee Peanuts instead of , Honey Roasted Peanuts listed on the label. Butter Toffee Peanuts contain a very small amount of butter (0.5% to 1.0%) which is a milk allergen. ",5/7/2013,"05/07/2013",6/19/2013,"06/19/2013"
"Devices",65352,"Ongoing","Olympus America Inc.","Center Valley","PA","US","Voluntary: Firm Initiated","Letter","Worldwide distribution: USA (nationwide) and the country of Canada.","Z-0329-2014","Class II","Olympus Endoscopic Flushing Pump, Model OPF-2. Facilitates washing of tissues to remove blood, feces and other organic matter during endoscopic procedures.","Model OPF-2 with serial numbers: 21301567 21301799 21220870 21220876 21220878 21220869 21301569 21220788 21220710 21220712 21220181 21220707 21301315 21301216 21301672 21301675 21301793 21301795 21301960 21303157 21303159 21303161 21303388 21303390 21303391 21301064 21221126 21301053 21301059 21301570 21301573 21301054 21220701 21301066 21301203 21301205 21301209 21301673 21220706 21301572 21301052 21301055 21301065 21301571 21220953 21302798 21302917 21302920 21302925 21303009 21303017 21301058 21301060 21301485 21301493 21301566 21301408 21301961 21301804 21221123 21301317 21301483 21301217 21301320 21301482 21301214 21220357 21301062 21220179 21220171 21220789 21301487 21301489 21303156 21220877 21301413 21220176 21220711 21302919 21301796 21301797 21301415 21301963 21220174 21220168 21220704 21301056 21220621 21301204 21301207 21301212 21301215 21301575 21301206 21301213 21301321 21301322 21301406 21301484 21301568 21220709 21301409 21301404 21303162 21220790 21302791 21301414 21301407 21220785 21301410 21301210 21301211 21303010 21303014 21301411 21301577 21301208 21302921 21302923 21303013 21303397 21301316 21220868 21220787 21302910 21302911 21302912 21302915 21302918 21302974 21303012 21302913 21302922 21302924 21302973 21303008 21303015 21301490 21301492 21221124 21301957 21301959 21301965 21301966 21301967 21301968 21220169 21220951 21220963 21301313 21303016 21301798 21301486 21301488 21301491 21220615 21220618 21220625 21221125 21302914 21220871 21220880 21301405 21221122 21220175 21302916 21303158 21303160 21303387 21303392 21303393 21303396 21303398 21220180 21220708 21301674 21220702 21220616 21220623 21220783 21220793 21220178 21220613 21220620 21301962 21220865 21301958 21220260 21302971 21303389 21301061 21220872 21220875 21220879 21220952 21220954 21220955 21220956 21220957 21220958 21220959 21",,"263","There is a possibility that the pump head was not shipped in the locked position. If the pump head is in an unlocked position this may, under certain circumstances, cause the pump to stop and go into power stand-by mode.",5/20/2013,"05/20/2013",11/27/2013,"11/27/2013"
"Food",65353,"Ongoing","Coca-Cola Refreshments USA, Inc.","Atlanta","GA","US","Voluntary: Firm Initiated","Letter","U.S. Nationwide.","F-1537-2013","Class II","MINUTE MAID STRAWBERRY PASSION Flavored Juice Beverage, 15.2 oz plastic (PET) bottles, Produced for The Coca Cola Company, Atlanta, GA 30313 USA.","Optimum Taste Date Code: NOV0413MDD3 and NOV1113MDA3, UPC Code: 025000048906.",,,"Products with the specific Lot Code and UPC Codes listed above are being retrieved because there is the potential that some of the bottles could exhibit spoilage or damage to the lip of the bottle.",5/28/2013,"05/28/2013",6/26/2013,"06/26/2013"
"Food",65353,"Ongoing","Coca-Cola Refreshments USA, Inc.","Atlanta","GA","US","Voluntary: Firm Initiated","Letter","U.S. Nationwide.","F-1538-2013","Class II","MINUTE MAID Mixed Berry Juice, Flavored Blend of Apple, Grape & Berry Juices, 6/10 oz plastic (PET) bottles, Produced for The Coca Cola Company, Atlanta, GA 30313 USA.","Optimum Taste Date Code: SEP2313MDD3 and SEP3013MDE3, UPC Code: 10025000056793, GTIN Unit UPC: 00025000056796.",,,"Products with the specific Lot Code and UPC Codes listed above are being retrieved because there is the potential that some of the bottles could exhibit spoilage or damage to the lip of the bottle.",5/28/2013,"05/28/2013",6/26/2013,"06/26/2013"
"Food",65353,"Ongoing","Coca-Cola Refreshments USA, Inc.","Atlanta","GA","US","Voluntary: Firm Initiated","Letter","U.S. Nationwide.","F-1535-2013","Class II","MINUTE MAID APPLE JUICE, 100% Juice, 6/10 oz and 15.2 oz, plastic (PET) bottles, Produced for The Coca Cola Company, Atlanta, GA 30313 USA. ","(10 oz) Optimum Taste Date Code: SEP3013MDB3, SEP3013MDD3 and SEP3013MDF3, UPC Code: 10025000056762, GTIN Unit UPC: 00025000056765; (15.2 oz) Optimum Taste Date Code: JAN0614MDC3 and JAN1314MDA3, UPC Code: 025000056017.",,,"Products with the specific Lot Code and UPC Codes listed above are being retrieved because there is the potential that some of the bottles could exhibit spoilage or damage to the lip of the bottle.",5/28/2013,"05/28/2013",6/26/2013,"06/26/2013"
"Food",65353,"Ongoing","Coca-Cola Refreshments USA, Inc.","Atlanta","GA","US","Voluntary: Firm Initiated","Letter","U.S. Nationwide.","F-1534-2013","Class II","MINUTE MAID ORANGE JUICE, 10oz and 15.2 oz plastic (PET) bottles, Produced for The Coca Cola Company, Atlanta, GA 30313 USA.","(15.2 oz) Optimum Taste Date Code: OCT0713MDF3, OCT0713MDE3, OCT1413MDC3, OCT1413MDB3, UPC Code: 025000056031; (10 oz) Optimum Taste Date Code: SEP2313MDF3, SEP3013MDC3 and SEP3013MDE3, UPC Code: 10025000056779, GTIN Unit UPC: 00025000056772.",,"Total 109, 922 cases ","Products with the specific Lot Code and UPC Codes listed above are being retrieved because there is the potential that some of the bottles could exhibit spoilage or damage to the lip of the bottle.",5/28/2013,"05/28/2013",6/26/2013,"06/26/2013"
"Food",65353,"Ongoing","Coca-Cola Refreshments USA, Inc.","Atlanta","GA","US","Voluntary: Firm Initiated","Letter","U.S. Nationwide.","F-1536-2013","Class II","MINUTE MAID CRANBERRY APPLE RASPBERRY Flavored Juice Beverage, 15.2 oz, plastic (PET) bottles, Produced for The Coca Cola Company, Atlanta, GA 30313 USA.","Optimum Taste Date Code: NOV0413MDB3, UPC Code: 025000056024.",,,"Products with the specific Lot Code and UPC Codes listed above are being retrieved because there is the potential that some of the bottles could exhibit spoilage or damage to the lip of the bottle.",5/28/2013,"05/28/2013",6/26/2013,"06/26/2013"
"Devices",65354,"Ongoing","Terumo Cardiovascular Systems Corporation","Ann Arbor","MI","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution - USA (nationwide) including the countries of Australia, Dubai, Hong Kong, Indonesia, Singapore, China, Mexico, British Columbia, Taiwan, Thailand, Chile, Malaysia, Japan, Belgium, United Arab Emirates (UAE), South Korea, Manila and Canada.","Z-1968-2013","Class II","Terumo Advanced Perfusion System 1: 100/120V AC, Advanced Perfusion System 1 The Terumo Advanced Perfusion System 1 is indicated for use in extracorporeal circulation of blood for arterial perfusion, regional perfusion, and cardiopulmonary bypass procedures only when used by a qualified perfusionist who is experienced in the operation of Sarns '' or similar equipment. ","Catalog number: 801763",,"1657","The operators manual does not fully describe the sequence of expected events that will occur when a specific operating condition exists. Specifically, if the user is adjusting the System 1 centrifugal pump speed via the Central Control Monitor at the same time an alarm condition occurs with configuration for a pump coast response, the labeling in the operators manual does not fully describe how the pump will react.",7/26/2013,"07/26/2013",8/21/2013,"08/21/2013"
"Devices",65354,"Ongoing","Terumo Cardiovascular Systems Corporation","Ann Arbor","MI","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution - USA (nationwide) including the countries of Australia, Dubai, Hong Kong, Indonesia, Singapore, China, Mexico, British Columbia, Taiwan, Thailand, Chile, Malaysia, Japan, Belgium, United Arab Emirates (UAE), South Korea, Manila and Canada.","Z-1969-2013","Class II","Terumo Advanced Perfusion System 1: 220/240V AC, Advanced Perfusion System 1 The Terumo Advanced Perfusion System 1 is indicated for use in extracorporeal circulation of blood for arterial perfusion, regional perfusion, and cardiopulmonary bypass procedures only when used by a qualified perfusionist who is experienced in the operation of Sarns '' or similar equipment.","Catalog number: 801764 ",,"1657","The operators manual does not fully describe the sequence of expected events that will occur when a specific operating condition exists. Specifically, if the user is adjusting the System 1 centrifugal pump speed via the Central Control Monitor at the same time an alarm condition occurs with configuration for a pump coast response, the labeling in the operators manual does not fully describe how the pump will react.",7/26/2013,"07/26/2013",8/21/2013,"08/21/2013"
"Devices",65355,"Ongoing","Zeiss, Carl Inc","Thornwood","NY","US","Voluntary: Firm Initiated","E-Mail","Distributed in the states of MI, TX, SD, FL, GA, NY, and NY.","Z-1744-2013","Class II","Polarizer D Fixed w/Rotating Red 1 lambda plate. Utilized in upright Zeiss microscopes to aid in diagnosis by means of color variation.","Model # 445226-0000-000",".","12 (1 in quarantine)","Carl Zeiss Microscopy, LLC is recalling the Polarizer D component used in All upright ZEISS microscopes (Axio Imager, Axio Scope.A1, Axio Lab.A1) due to Misaligned Full-Wave (Lambda) Plate.",5/28/2013,"05/28/2013",7/24/2013,"07/24/2013"
"Devices",65356,"Ongoing","B. Braun Medical, Inc.","Allentown","PA","US","Voluntary: Firm Initiated","Letter","Nationwide Distribution","Z-0425-2014","Class II","13mm addEASE(TM) Binary Connector with 17 Ga. Needle for use with PAB(R) Containers, BC1300 Product is intended for fluid transfer between a Partial Additive Bag (PAB(R)) container and a drug vial. ","Material BC1300, Lot number 61286479.",".","4,000 units","Possible solution leakage at the interface of the addEASE(TM) Binary Connector (Product Codes BC2000 and BC1300) and the PAB(R) bag. Based on extensive root cause investigation, it has been determined that the leakage is the result of a misaligned cannula (needle) on the addEASE(TM) Binary Connector, which pierces the PAB(R) bag stopper to access the solution. The misaligned cannula may result in an inadequate seal at the cannula and stopper interface and ultimately may cause solution leakage.",4/4/2013,"04/04/2013",12/4/2013,"12/04/2013"
"Devices",65356,"Ongoing","B. Braun Medical, Inc.","Allentown","PA","US","Voluntary: Firm Initiated","Letter","Nationwide Distribution","Z-0424-2014","Class II","20mm addEASE(TM) Binary Connector with 17 Ga. Needle for use with PAB(R) Containers, BC2000 Product is intended for fluid transfer between a Partial Additive Bag (PAB(R)) container and a drug vial. ","Material BC2000, Lot numbers 0061275133, 0061275135, 0061275136, 0061279143, 0061279144, 0061279145, 0061279146, 0061289059, 0061289060, 0061289061, 0061289062, 0061289063, 0061289064, 0061289065, 0061289066, 0061289067 and 0061299664.",".","1,746,079 units","Possible solution leakage at the interface of the addEASE(TM) Binary Connector (Product Codes BC2000 and BC1300) and the PAB(R) bag. Based on extensive root cause investigation, it has been determined that the leakage is the result of a misaligned cannula (needle) on the addEASE(TM) Binary Connector, which pierces the PAB(R) bag stopper to access the solution. The misaligned cannula may result in an inadequate seal at the cannula and stopper interface and ultimately may cause solution leakage.",4/4/2013,"04/04/2013",12/4/2013,"12/04/2013"
"Food",65357,"Ongoing","Gromex Inc.","Passaic","NJ","US","Voluntary: Firm Initiated","Letter","CT, NJ, NY, PA","F-1542-2013","Class II","Gromex Anelina Net Wt. 1/2 oz. Gromex 43 First St., Passaic, NJ 07055 (973) 458-9399 ","None",,"unknown","Whole dried shrimp may contain undeclared bi-sulfites. Anelina contains undeclared and unapproved colors..",5/10/2013,"05/10/2013",6/26/2013,"06/26/2013"
"Food",65357,"Ongoing","Gromex Inc.","Passaic","NJ","US","Voluntary: Firm Initiated","Letter","CT, NJ, NY, PA","F-1541-2013","Class II","Gromex Camaron Entero (Whole Shrimp) Net Wt. 1 1/2 oz. 43 First St., Passaic, NJ 07055 (973) 458-9399 ","None",,"unknown","Whole dried shrimp may contain undeclared bi-sulfites. Anelina contains undeclared and unapproved colors..",5/10/2013,"05/10/2013",6/26/2013,"06/26/2013"
"Biologics",65358,"Ongoing","One Lambda Inc","Canoga Park","CA","US","Voluntary: Firm Initiated","Letter","USA, Canada, Germany, Israel, Poland, Spain, Brazil, Japan, Singapore, Thailand, and Vietnam.","B-2026-13","Class II","Micro SSP'' Allele Specific HLA Class I DNA Typing Tray B*38/39, Catalog Identification: SSPR1-16 Micro SSP'' Allele Specific HLA Class I DNA Typing Tray B*38/39 Catalog Identification: SSPR1-16 Article Number: SSP_DNAT_PI Rev 18 Lot number: 002, batches 001-003 510(K) Number : BK960062","Micro SSP'' Allele Specific HLA Class I DNA Typing Tray B*38/39 Catalog Identification: SSPR1-16 Article Number: SSP_DNAT_PI Rev 18 Lot number: 002, batches 001-003 ",,"1 device distributed","Micro SSP Allele Specific HLA Class I DNA Typing Trays (B*38/39), manufactured with an incorrect primer, were distributed. ",5/22/2013,"05/22/2013",8/7/2013,"08/07/2013"
"Food",65359,"Ongoing","Townsend Farms Inc","Fairview","OR","US","Voluntary: Firm Initiated","Press Release","Product was distributed from Townsend Farms to consignees' distribution centers in Arizona, California, North Carolina, Utah, and Washington.","F-0701-2014","Class I","The Costco product is sold under brand name Townsend Farms Organic Antioxidant Blend - The product is a mix of IQF organic berries, specifically; dark tart cherries, pomegranate arils, strawberries, red raspberries, and blueberries. The product is packaged into plastic bags with a net wt. 48oz (3 lbs) 1.36kg. There are 12 bags in a case. The Costco item # is 595820 and has the UPC 0 78414 40444 8. Harris Teeter Organics Antioxidant Berry Blend - The product is a mix of IQF organic berries, specifically; dark tart cherries, pomegranate arils, strawberries, red raspberries, and blueberries. The product is packaged into plastic bags with a net wt. 10 oz (283 g). There are 12 bags in a case. The Harris Teeter product has the UPC 0 72036 70463 4. For the Costco product there are two different labels: The first Costco product label reads in part ''*** USDA ORGANIC***Organic Antioxidant Blend*** DARK TART CHERRIES, POMEGRANATE ARILS, STRAWBERRIES, RED RASPBERRIES, BLUEBERRIES***Townsend Farms *** Individually Quick Frozen KEEP FROZEN *** NET WT. 48oz (3 LBS) 1.36KG ***''. The second Costco product label reads in part ''***HEART HEALTHY HIGH IN ANTIOXIDANTS***Organic Antioxidant Blend***DARK TART CHERRIES, BLUEBERRIES, POMEGRANATE ARILS, RED RASPBERRIES, STRAWBERRIES***Individually Quick Frozen All Natural No Preservatives*** USDA ORGANIC***Townsend Farms *** Grower Processor Distributor*** KEEP FROZEN *** Net Wt. 48oz (3 lbs) 1.36kg***ITEM #595820***''. The Harris Teeter label reads in part ''***HARRIS TEETER***Organics Antioxidant Berry Blend***Organic Dark Cherries, Organic Blueberries, Organic Pomegranate, Organic Red Raspberries & Organic Strawberries *** USDA ORGANIC***NET WT 10 OZ (283 G)***KEEP FROZEN *** PROUDLY DISTRIBUTED BY: HARRIS TEETER *** MATHEWS, NC 28105 ***''.","Costco Townsend Farms Organic Antioxidant Blend: BEST BY from T012415 sequentially through T053115, followed by a letter and BEST BY from T122114 sequentially through T053115, followed by a letter. All letter designations are included in the voluntary recall. Harris Teeter Organics Antioxidant Berry Blend product has lot codes T041613C and T041613E and the BEST BY code 101614. The codes are breakdown as: Townsend Farms Organic Antioxidant Blend: T = Townsend, 053115 = a two year best by date from the day it was manufactured, Letter = a two hour window of production; Harris Teeter Organic Antioxidant Berry Blend - T = Townsend, 041613 = the date the product was produced, C or E = a two hour window of production, BEST BY 101614 = 18 month best by date.",".","504,060 retail packages (3 lbs.) and 6,300 retail packages (10 oz.)","Harris Teeter Organics Antioxidant Berry Blend (10 oz.) and Townsend Farms Organic Antioxidant Blend (3 lbs.) are recalled because it has the potential to be contaminated with Hepatitis A virus, based on an ongoing epidemiological and traceback investigation by the FDA and the CDC, of an illness outbreak.",6/3/2013,"06/03/2013",12/11/2013,"12/11/2013"
"Devices",65361,"Ongoing","RF Technologies, Inc.","Brookfield","WI","US","Voluntary: Firm Initiated","Letter","Nationwide Distribution in US including the states of AK, AZ, CA, GA, IA, KY, MT, NE, NJ, ND, and WI.","Z-1597-2013","Class II","Code Alert Advanced 4-Way Care Solution, CA520 System, PN 9600-1600, RF Technologies. This product is used to alert caregivers when a patient at risk for falls is leaving a bed or chair.","all codes",,"167","RF Technologies, Inc. has initiated a recall involving CA520 Code Alert Integrated Care Management Advanced 4-Way Care Solution . Due to a firmware error, the alarm may not be transmitted to the system server immediately. ",5/17/2013,"05/17/2013",7/3/2013,"07/03/2013"
"Devices",65362,"Ongoing","Integra LifeSciences Corp.","Plainsboro","NJ","US","Voluntary: Firm Initiated","Letter","USA Nationwide Distribution","Z-1568-2013","Class III","CMC Saddle Product Usage: The Ascension CMC is intended to resurface the proximal end of the first metacarpal in cases of rheumatoid arthritis, traumatic arthritis, osteo-arthritis, or post-fracture deformation or bone loss which present as either a painful, unstable thumb, or a thumb with limited range of motion. This is an uncemented prosthesis designed for press fit use only.","Lot/Serial Number: 111602, 110864, 102815, 091515, 092563, 110863. Product/Catalogue No: CMC-410-10, CMC-410-20, CMC-410-30, CMC-410-40. ",,"467 devices","As a result of a quality review, labelling content discrepancies were identified between the Instruction for Use (IFU) distributed in the US with the Ascension CMC and the content that is cleared by FDA.",6/3/2013,"06/03/2013",7/3/2013,"07/03/2013"
"Food",65363,"Ongoing","General Mills, Inc","Minneapolis","MN","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","The recall involved 2 customers with 6 shipping locations. WV, SC, VA, GA, TN.","F-1589-2013","Class I","General Mills, Cinnamon Toast Crunch, 25% Less Sugar, Self-Serve Bowl, Net WT 1.0 oz ( 28g), Distributed by General Mills Sales, Minneapolis, MN 55440, Package UPC 00016000294448. Case: General Mills, BOWLPAK, Cinnamon Toast Crunch, Reduced Sugar, 96 - 1 oz (28g) containers, Distributed by General Mills Sales, Minneapolis, MN 55440, Case UPC 10016000294445.","Better if Used By: Case Date Code: 31AUG2013, 02SEP2013 ",".","168 cases ( 96 individual 1.0 oz bowlpacks)","General Mills is recalling a small quantity of single-serve reduced-sugar Cinnamon Toast Crunch bowlpak sold in foodservice establishments. The company was notified by an ingredient supplier that it had recalled an ingredient due to the possible presence of salmonella. ",6/4/2013,"06/04/2013",7/10/2013,"07/10/2013"
"Devices",65364,"Ongoing","Baxter Healthcare Corp.","Round Lake","IL","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution - USA (nationwide), Puerto Rico, and Internationally to Brazil, Colombia, Panama, Mexico, Singapore Japan, Australia, New Zealand, Hong Kong, India, Thailand, Taiwan, and Korea.","Z-1609-2013","Class II","Brand Name: Coiled Tube Infusors (Portable Elastomeric Infusion Systems). Baxter's Infusor SV Elastomeric Infusion Device Device Listing: D020871 Baxter's lnfusors SV Elastomeric Infusion Device is a single-use, disposable elastomeric infusion pump indicated tor patients requiring slow, continuous intravenous, intra-arterial, subcutaneous, or epidural administration of medications at a constant flow rate. ","Product Code: 2C1073KJP Lot Numbers: 08M002, 08N007, 08N029, 08N030, 08N034, 08N069, 08N070, 09A001",,"601,230 total","Baxter Healthcare Corporation (Baxter) is issuing an Urgent Product Recall for the products listed above due to an increase in complaints for leaks at the distal male Luer and Luer cap. Baxter implemented enhancements to the blue winged cap to improve the seal between the cap and the Luer. Complaint rates for leaks have since decreased. Baxter wants to ensure that no affected product remains in the field. ",6/7/2013,"06/07/2013",7/3/2013,"07/03/2013"
"Devices",65364,"Ongoing","Baxter Healthcare Corp.","Round Lake","IL","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution - USA (nationwide), Puerto Rico, and Internationally to Brazil, Colombia, Panama, Mexico, Singapore Japan, Australia, New Zealand, Hong Kong, India, Thailand, Taiwan, and Korea.","Z-1610-2013","Class II","Brand Name: Coiled Tube Infusors. Multiday lnfusor, Seven Day lnfusor and the Basal/Bolus lnfusor: Single day Infusor 2 ml/h, Single Day INFUSOR 2 ml/h System, Half Day INFUSOR SV 5 ml/h System, Two Day INFUSOR 2 ml/h System, Two day Infusor 2 ml/h, Two Day INFUSOR 2ml/h System, Multiday Infusor 0.5 ml/h, Multiday INFUSOR 0.5ml/h System, Seven Day Infusor 0.5 ml/h, Seven Day INFUSOR 0.5ml/h System, Basal-Bols Infusor-15min., Basal/Bolus INFUSOR 0.5 x 2 ml/h System with 15 Minute Lockout, Basal-Bolus Infusor Device Listing: D018045 The Multiday lnfusor. Seven Day lnfusor and the BasaVBolus lnfusor are indicated for patients requiring slow, continuous intravenous, intra-arterial, subcutaneous or epidural administration of medications. ","Product Codes: 2C1071KJP, 2C1073KJP, 2C1075KJP, 2C1080KJP, 2C1082KJP, 2C1955KJP, 2C1976KJ. Expiration Dates: 06/30/13, 12/31/13, 06/30/14, 12/31/14",,"601,230 total","Baxter Healthcare Corporation (Baxter) is issuing an Urgent Product Recall for the products listed above due to an increase in complaints for leaks at the distal male Luer and Luer cap. Baxter implemented enhancements to the blue winged cap to improve the seal between the cap and the Luer. Complaint rates for leaks have since decreased. Baxter wants to ensure that no affected product remains in the field. ",6/7/2013,"06/07/2013",7/3/2013,"07/03/2013"
"Devices",65365,"Ongoing","Baxter Healthcare Corporation","Irvine","CA","US","Voluntary: Firm Initiated","Letter","Distributed Nationwide and in Puerto Rico.","Z-1606-2013","Class II","Brand Name: Basal/Bolus Infusor. Indicated for the intravenous administration of medications. ","Product Codes: 2C1955KJP, 2C1976KJ Lot Codes: 08K006 08M038 08N001 09C021 09E028 09F078 09H080 09J046 09M052 09N030 09N048 10A043 108023 10E054 10H055 10J031 10K050 10M085 10N026 09H033 10B028 10B081 10E004 10J106 Expiration Dates: 06/30/15, 12/31/14, 12/31/15, 06/30/14, 12/31/14",,"3,255,096 total","Baxter Healthcare Corporation (Baxter) is issuing an Urgent Product Recall for the products listed above due to an increase in rupture complaints. Baxter has implemented product and process improvements which have substantially improved product quality. Complaint rates for ruptures have since decreased. Baxter wants to ensure that no affected product remains in the field. ",6/7/2013,"06/07/2013",7/3/2013,"07/03/2013"
"Devices",65365,"Ongoing","Baxter Healthcare Corporation","Irvine","CA","US","Voluntary: Firm Initiated","Letter","Distributed Nationwide and in Puerto Rico.","Z-1604-2013","Class II","Brand Name: Intermate Infusion Pump. Indicated for the intravenous administration of medications. ","Product Codes: 2C1730K, 2C1732K, 2C1734K, 2C1740K, 2C1743K, 2C1744K Lot Codes: 10F009 10F049 10F053 10F057 10F095 10J006 10J079 10K077 10M067 10F004 10F015 10G016 10G017 10G018 10G019 10G053 10G054 10H007 10H008 10H009 10H049 10H050 10H051 10H079 10H080 10H081 10H108 10J002 10J009 10J011 10J012 10J077 10J078 10J083 10K009 10K010 10K011 10K012 10K014 10K018 10K070 10K071 10K072 10M015 10M061 10M066 10M071 10M073 10M074 10M082 10F010 10F011 10F079 10G021 10G022 10G023 10H010 10H025 10H026 10H047 10J003 10J004 10J005 10J080 10J081 10J082 10J093 10K016 10K017 10K019 10M008 10M010 10M075 10M078 10M080 10M081 10H083 10M065 10F051 10F073 10G039 10G040 10J007 10J008 10J109 10K007 10K057 10K106 10M064 10M070 10F005 10F006 10F052 6/19/2010 6/22/2010 6/23/2010 8/13/2010 8/23/2010 8/30/2010 9/3/2010 9/30/2010 10/4/2010 10/21/2010 10/26/2010 11/4/2010 11/15/2010 11/24/2010 Expiration Date: 06/30/13",,"3,255,096 total","Baxter Healthcare Corporation (Baxter) is issuing an Urgent Product Recall for the products listed above due to an increase in rupture complaints. Baxter has implemented product and process improvements which have substantially improved product quality. Complaint rates for ruptures have since decreased. Baxter wants to ensure that no affected product remains in the field. ",6/7/2013,"06/07/2013",7/3/2013,"07/03/2013"
"Devices",65365,"Ongoing","Baxter Healthcare Corporation","Irvine","CA","US","Voluntary: Firm Initiated","Letter","Distributed Nationwide and in Puerto Rico.","Z-1602-2013","Class II","Brand Name: Regional Analgesia Infusor System with Patient Control. Indicated for the intravenous administration of medications. ","Product Codes: 2C1154KP, 2C1155KP, 2C9960KP, 2C9961KP Lot Numbers: 10F030 10F066 10H043 10H104 10K027 10K099 10M090 10G028 10J059 10M019 10M089 10F058 10G069 10G042 10J048 10M026 Expiration Date: 06/30/13",,"3,255,096 total","Baxter Healthcare Corporation (Baxter) is issuing an Urgent Product Recall for the products listed above due to an increase in rupture complaints. Baxter has implemented product and process improvements which have substantially improved product quality. Complaint rates for ruptures have since decreased. Baxter wants to ensure that no affected product remains in the field. ",6/7/2013,"06/07/2013",7/3/2013,"07/03/2013"
"Devices",65365,"Ongoing","Baxter Healthcare Corporation","Irvine","CA","US","Voluntary: Firm Initiated","Letter","Distributed Nationwide and in Puerto Rico.","Z-1603-2013","Class II","Brand Name: Intermate Infusion Pump. Indicated for the intravenous administration of medications. ","Product Codes: 2C1064K Lot Codes: 10F007 10F077 10H075 10J097 10K076 10K112 10M062 Expiration Date: 06/30/13",,"3,255,096 total","Baxter Healthcare Corporation (Baxter) is issuing an Urgent Product Recall for the products listed above due to an increase in rupture complaints. Baxter has implemented product and process improvements which have substantially improved product quality. Complaint rates for ruptures have since decreased. Baxter wants to ensure that no affected product remains in the field. ",6/7/2013,"06/07/2013",7/3/2013,"07/03/2013"
"Devices",65365,"Ongoing","Baxter Healthcare Corporation","Irvine","CA","US","Voluntary: Firm Initiated","Letter","Distributed Nationwide and in Puerto Rico.","Z-1600-2013","Class II","Brand Name: Infusor SV and LV Elastomeric Infusion Devices. Indicated for the intravenous administration of medications. ","Product Codes: 2C1008KP, 2C1009KP, 2C1063KP, 2C1087KP, 2C1156KP, 2C1700KP, 2C1702KP Lot Codes: 10F032 10G056 10H066 10J047 10K024 10K087 10M021 10M088 10F059 10F069 10F070 10G029 10G043 10G062 10G067 10H032 10H093 10J049 10J060 10J089 10J105 10K028 10K030 10K038 10K088 10K096 10K102 10M025 10M044 10F022 10F068 10F072 10G030 10G045 10G046 10G047 10G050 10G051 10H016 10H018 10H087 10H094 10J053 10J058 10J062 10J102 10K026 10K035 10K039 10K086 10M023 10M040 10M043 10M045 10F020 10F087 10H086 10H095 10J017 10J020 10J056 10J068 10K021 10K029 10K031 10K081 10K105 10M017 10M039 10J052 10K098 10F064 10H044 10K022 10K042 10F024 10F025 10F033 10F055 10F062 10F063 10F065 10H005 10H030 10H042 10J015 10J019 10J061 10J065 10K032 10K037 10K095 10M030 10M087 10M098 10M099 10M100 Expiration Date: 06/30/13",,"3,255,096 total","Baxter Healthcare Corporation (Baxter) is issuing an Urgent Product Recall for the products listed above due to an increase in rupture complaints. Baxter has implemented product and process improvements which have substantially improved product quality. Complaint rates for ruptures have since decreased. Baxter wants to ensure that no affected product remains in the field. ",6/7/2013,"06/07/2013",7/3/2013,"07/03/2013"
"Devices",65365,"Ongoing","Baxter Healthcare Corporation","Irvine","CA","US","Voluntary: Firm Initiated","Letter","Distributed Nationwide and in Puerto Rico.","Z-1605-2013","Class II","Brand Name: SV Elastomeric Infusion Device. Indicated for the intravenous administration of medications. ","Product Codes: 2C1071KJP, 2C1073KJP, 2C1075KJP Lot Codes: 08J078 08K002 08K005 08K007 08K054 08K066 08M001 08M025 08M028 08M039 08N003 08N005 08N032 09A004 09A040 09A042 09A064 98025 98027 98028 98070 09(018 09C023 09(024 09C045 09C047 09(075 90029 90031 90033 90065 90069 90086 09E026 09E027 09E031 09F023 09F024 09F025 09F040 09F041 09F042 09G013 09G061 09G062 09H004 09H008 09H035 09H036 09H070 09H082 09J006 09J007 09J074 09J075 09K017 09K018 09K021 09K022 09K086 09K087 09M002 09M005 09M037 09M038 09M039 09M078 09N027 09N028 09N029 09N034 10A019 10A020 10A021 10A044 108010 108029 10C002 10C003 10C006 10C078 10C079 10C099 10C103 10C111 100026 100027 100028 100058 100062 100063 10E003 10E008 10E009 10E067 10G005 10G006 10G007 10G008 10G078 10G079 10H014 10H019 10H020 10H022 10H054 10H056 10H057 10H060 10H069 10H071 10H105 10H107 10J022 10J023 10J026 10J028 10J029 10J070 10J071 10J074 10K043 10K044 10K047 10K049 10K051 10K061 10K065 10K110 10M056 10M058 10M059 10M060 10N006 10N024 10N028 10N078 11A022 11A024 11A030 11A052 11A074 11A075 08K001 08K003 08K053 08K077 08M002 08N007 08N029 08N030 08N034 08N069 08N070 09A001 09A063 98026 98069 98071 09C046 90025 90032 90070 09E030 09F022 09F026 09G010 09H005 09H037 09J005 09J042 09J043 09J044 09J045 09J089 09K020 09K050 09M001 09M041 09N032 09N041 10A017 10A022 10A046 108014 108024 10C076 10C100 10C102 100025 100029 10E002 10E007 10E045 10E055 10G001 10G003 10G004 10H024 10H058 10H059 10H072 10J021 10J024 10J027 10J072 10K046 10K048 10K063 10K064 10M034 10M057 10N023 10N077 11A023 11A031 11A054 08K067 08M003 09A006 98078 90026 90085 09E052 09H001 09J071 09K053 09M003 09M077 108025 10C005 10C080 10C101 100059 10E053 10H023 10H106 10J030 10J045 10J069 10K066 10M086 10N027 11A025 Expiration Dates: 06/30/13, 12/31/13, 12/31/14, ",,"3,255,096 total","Baxter Healthcare Corporation (Baxter) is issuing an Urgent Product Recall for the products listed above due to an increase in rupture complaints. Baxter has implemented product and process improvements which have substantially improved product quality. Complaint rates for ruptures have since decreased. Baxter wants to ensure that no affected product remains in the field. ",6/7/2013,"06/07/2013",7/3/2013,"07/03/2013"
"Devices",65365,"Ongoing","Baxter Healthcare Corporation","Irvine","CA","US","Voluntary: Firm Initiated","Letter","Distributed Nationwide and in Puerto Rico.","Z-1601-2013","Class II","Brand Name: Multirate Infusor Devices. Indicated for the intravenous administration of medications. ","Product Codes: 2C1154KP, 2C1155KP, 2C9960KP, 2C9961KP Lot Numbers: 10F030 10F066 10H043 10H104 10K027 10K099 10M090 10G028 10J059 10M019 10M089 10F058 10G069 10G042 10J048 10M026 Expiration Date: 06/30/13",,"3,255,096 total","Baxter Healthcare Corporation (Baxter) is issuing an Urgent Product Recall for the products listed above due to an increase in rupture complaints. Baxter has implemented product and process improvements which have substantially improved product quality. Complaint rates for ruptures have since decreased. Baxter wants to ensure that no affected product remains in the field. ",6/7/2013,"06/07/2013",7/3/2013,"07/03/2013"
"Biologics",65367,"Terminated","American Red Cross Blood Services Tennessee Valley Region","Nashville","TN","US","Voluntary: Firm Initiated","Telephone","Tennessee; Kentucky","B-2077-13","Class II","Red Blood Cells Leukocytes Reduced","W201913001505; W201913001495; W201913001508; W201913001499; ",,"4","Blood products, collected using an inadequate reagent to perform the arm scrub, were distributed.",4/16/2013,"04/16/2013",9/4/2013,"09/04/2013"
"Biologics",65368,"Terminated","Sanofi Pasteur, Inc.","Swiftwater","PA","US","Voluntary: Firm Initiated","Other","Multiple U.S. States","B-2189-13","Class III","Typhoid Vi Polysaccharide Vaccine","E12871; E12881; G04811; G05071; G05081; G11301",".","6 Lots","Lots of Typhim Vi (Typhoid Vi Polysaccharide Vaccine), with potentially low antigen content, were distributed. ",9/25/2012,"09/25/2012",9/11/2013,"09/11/2013"
"Devices",65369,"Ongoing","Carestream Health Inc.","Rochester","NY","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution - USA (nationwide) including the countries of Austria, Australia, Belgium, Canada, China, Finland, France, Germany, Italy, Korea, Kuwait, Saudi Arabia, Spain, Sweden, Switzerland, Taiwan, United Kingdom.","Z-1877-2013","Class II","Carestream DRX Evolution System, X-ray system --- The DRX-Evolution system is a permanently installed diagnostic x-ray system for generation of x-rays for examination of various anatomical regions. ","Carestream DRX Evolution System using V5.5.410.33 MR2 Software",,"US: 44 units; Foreign: 243 units","To a potential for an x-ray exposure technique change.",6/3/2013,"06/03/2013",8/21/2013,"08/21/2013"
"Devices",65370,"Ongoing","Smith & Nephew Inc","Memphis","TN","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Worldwide Distribution-USA including the states of PA, WA, TX, FL, IA, MI, WI, TN, KY, IN, NY, MO and OR, and the countries of India, Canada, Chile, Venezuela, Dubai, South Africa, Australia, Poland, Romania, Belgium, Germany and United Kingdom.","Z-1929-2013","Class II","R3 (TM) XLPE ACETABULAR LINER UHMWPE, 20o OVERHANG, 36 MM ID, 60 MM OD, QTY: (1), STERILE H2O2, REF 71335760. Orthopaedic.","Batch No. 12FM00602",".","53 units","One batch of 60 mm 20o R3 XLPE liner may be laser etched and packaged as a 62 mm 20o liner and one batch of 62 mm 20o R3 XLPE liner may be laser etched and packaged as a 60 mm 20o liner.",5/29/2013,"05/29/2013",8/14/2013,"08/14/2013"
"Devices",65370,"Ongoing","Smith & Nephew Inc","Memphis","TN","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Worldwide Distribution-USA including the states of PA, WA, TX, FL, IA, MI, WI, TN, KY, IN, NY, MO and OR, and the countries of India, Canada, Chile, Venezuela, Dubai, South Africa, Australia, Poland, Romania, Belgium, Germany and United Kingdom.","Z-1928-2013","Class II","R3 (TM) XLPE ACETABULAR LINER UHMWPE, 20o OVERHANG, 36 MM ID, 62 MM OD, QTY: (1), STERILE H2O2, REF 71335762. Orthopaedic. ","Batch No. 12FM00603",".","53 units","One batch of 60 mm 20o R3 XLPE liner may be laser etched and packaged as a 62 mm 20o liner and one batch of 62 mm 20o R3 XLPE liner may be laser etched and packaged as a 60 mm 20o liner.",5/29/2013,"05/29/2013",8/14/2013,"08/14/2013"
"Devices",65371,"Ongoing","U-systems Inc","Sunnyvale","CA","US","Voluntary: Firm Initiated","Letter","Distributed in California and Illinois.","Z-1587-2013","Class II","Soma v Automated Breast Ultrasound System (ABUS), Automated Breast Ultrasound. Indicated as an adjunct to mammography for breast cancer screening. ","Serial numbers: H1280099, H1180094, B1380105",,"3 units","Devices labeled for an intended use not included in the existing 510(k) or PMA, in that, the user manual contains the Indication for Use of the soma v Platinum ABUS [a 510(k) product].",5/16/2013,"05/16/2013",7/3/2013,"07/03/2013"
"Devices",65372,"Ongoing","GE Healthcare, LLC","Waukesha","WI","US","Voluntary: Firm Initiated","Letter","Nationwide Distribution including the states of NJ, CO, LA, AL, OH, MA, NC, ME, WI, GA, PA, TX, IN, NY, MO, KY, KS, CA, MN, FL and IL.","Z-1519-2013","Class II","GE Healthcare Senographe Essential System. The Senographe 2000D system generates digital mamnmographic images that can be used for screening and in the diagnosis of breast cancer. The Senographe 2000D is intended to be used in the same clinical applications as traditional film-based mamnmographic systems.","Models 5144816-10 rev 2, 3 or 6 and 5144816-10-LE rev1.",,"49 installed in the US.","GE Healthcare has recently become aware of a potential issue due to inaccessible Operator Instructions associated with the defective Operator Manual CD of the Senographe Essential. ",1/14/2013,"01/14/2013",7/3/2013,"07/03/2013"
"Food",65373,"Ongoing","Creole & Company, LLC","new orleans","LA","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","LA","F-1645-2013","Class I","Creole & Company Creole Bisque, NET WEIGHT 3.47 oz (98g), manufacture for: Creole & Company, 145 Robert E. Lee Blvd. Penthouse Suite, New Orleans, LA 70124, UPC: 811773014869","None, the product is not lot coded",".","22 cases of 20 units","Product which contains milk, soy, and wheat was distributed without an ingredient statement which declares their presence.",6/6/2013,"06/06/2013",7/17/2013,"07/17/2013"
"Devices",65374,"Ongoing","Utah Medical Products, Inc","Midvale","UT","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Worldwide Distribution - United States Nationwide in the states of (MO, NE, KY, FL, OH, NY), and countries of Columbia, Brazil, Venezuela. West Indies, Latin America, Ecuador are distributed through a US direct consignee exporter.","Z-1543-2013","Class II","Deltran Disposable Pressure Transducer Kit (DPT Kit) Extracorporeal disposable pressure transducer and tubing set with integral stopcock and flush device, Product Usage: Deltran is a disposable pressure transducer that provides consistent and accurate readings during invasive blood pressure monitoring of humans and animals.","Part number DPT-248A, lot number 1122508.",".","1,800 kits","Utah Medical Products, Inc. is recalling certain Deltran Disposable Pressure Transducer Kits due to complaints related to packaging integrity of the sterile packaged devices.",6/4/2013,"06/04/2013",6/19/2013,"06/19/2013"
"Food",65375,"Ongoing","ARO Pistachios, Inc.","Terra Bella","CA","US","Voluntary: Firm Initiated","Telephone","CA, TX, MN, OR, NY, MI, UT, IA, AL, VA, NJ,AZ, GA, PA. and FL, IL, SC, OH, MA, NE, KY, UT, CT, LA, IN, DC, KS, OK, NH,, RI,, NC, MD, AK,","F-1634-2013","Class I","ARO Pistachios, Inc., Pistachios roasted inshell - no salt; 25 lb bulk .","All codes from 2012 crop year.",".","~550,000 lbs total crop year.","Epidemiological evidence in Salmonella Senftenberg outbreak points to product produced at firm.",6/4/2013,"06/04/2013",7/17/2013,"07/17/2013"
"Food",65375,"Ongoing","ARO Pistachios, Inc.","Terra Bella","CA","US","Voluntary: Firm Initiated","Telephone","CA, TX, MN, OR, NY, MI, UT, IA, AL, VA, NJ,AZ, GA, PA. and FL, IL, SC, OH, MA, NE, KY, UT, CT, LA, IN, DC, KS, OK, NH,, RI,, NC, MD, AK,","F-1633-2013","Class I","ARO Pistachios, Inc., Pistachios roasted/salted, in shell; sold in 6 oz. in shell R/S Poly Resealable bag; 1 lb. in shell R/S Poly Resealable bag; 2 lb. R/S airtight Jar 5 lb. in shell R/S Poly Resealable bag 25 lb bulk in shell R/S","All codes from 2012 crop year.",".","~550,000 lbs total crop year.","Epidemiological evidence in Salmonella Senftenberg outbreak points to product produced at firm.",6/4/2013,"06/04/2013",7/17/2013,"07/17/2013"
"Food",65375,"Ongoing","ARO Pistachios, Inc.","Terra Bella","CA","US","Voluntary: Firm Initiated","Telephone","CA, TX, MN, OR, NY, MI, UT, IA, AL, VA, NJ,AZ, GA, PA. and FL, IL, SC, OH, MA, NE, KY, UT, CT, LA, IN, DC, KS, OK, NH,, RI,, NC, MD, AK,","F-1632-2013","Class I","ARO Pistachios, Pistachios raw kernel - no salt; Sold in 9 oz. raw kernel, no salt airtight jar; 2.5 lb raw Kernel, no salt, air tight jar; 30 lb Bulk raw kernel, no salt.","all codes in 2012 crop year.",".","~550,000 pounds 2012 crop year.","Epidemiological evidence in Salmonella Senftenberg outbreak points to product produced at firm.",6/4/2013,"06/04/2013",7/17/2013,"07/17/2013"
"Food",65375,"Ongoing","ARO Pistachios, Inc.","Terra Bella","CA","US","Voluntary: Firm Initiated","Telephone","CA, TX, MN, OR, NY, MI, UT, IA, AL, VA, NJ,AZ, GA, PA. and FL, IL, SC, OH, MA, NE, KY, UT, CT, LA, IN, DC, KS, OK, NH,, RI,, NC, MD, AK,","F-1635-2013","Class I","ARO Pistachios, Inc., Pistachios inshell - raw; 25 lb bulk .","All codes from 2012 crop year.",".","~550,000 lbs. total crop year.","Epidemiological evidence in Salmonella Senftenberg outbreak points to product produced at firm.",6/4/2013,"06/04/2013",7/17/2013,"07/17/2013"
"Devices",65376,"Ongoing","Respironics California Inc","Carlsbad","CA","US","Voluntary: Firm Initiated","Letter","Worldwide distribution: US (nationwide) and countries of: Argentina, Australia, Austria, Bahrain, Belgium, Bolivia, Brazil, Canada, Chile, China, Croatia, Czech Republic, Denmark, Dominican Rep., Ecuador, Egypt , Finland, France, Germany, Hong Kong, Iceland, India, Indonesia, Iran, Ireland, Israel, Italy, Kenya, Kuwait, Lebanon, Libya, Malaysia, Malta, Mexico, Morocco, Namibia, Netherlands, New Zealand, Norway, Oman, Panama, Paraguay, Peru, Philippines, Poland, Portugal, Puerto Rico, Qatar, Reunion, Russian Fed., Saudi Arabia, Singapore, Slovenia, South Africa, South Korea, Spain, Sweden, Switzerland, Taiwan, Thailand, Turkey, United Kingdom, Utd.Arab.Emir. and Vietnam.","Z-1537-2013","Class I","Respironics V60 Ventilator, Model #V60 Respironics Material P/N (Philips 12 Digit P/N): 85008 (85008) 1053613 (989805628251) 1053614 (989805612101) 1053615 (989805613391) 1053616 (989805613661) 1053617 (989805611761) 1053618 (n/a) R1053618 (n/a) 1076709 (n/a) 1076715 (989805627411) 1076716 (989805627431) 1076717 (989805627441) DU1053617 (989805616411) U1053614 (989805636441) U1053617 (989805636631) Power Mgmt. Board, Respironics Material P/N: 1054358, Philips 12 Digit P/N: 4536561512581. The V60 Ventilator is an assist Ventilator and is intended to augment patient breathing. It is intended for spontaneously breathing individuals who require mechanical ventilation: patients with respiratory failure, respiratory insufficiency, or obstructive sleep apnea in a hospital or other institutional settings under the direction of a physician. The V60 Ventilator is intended to support pediatric patients weighing 20kg (44 lbs.) or greater to adult patients. It is also intended for intubated patients meeting the same selection criteria as the noninvasive applications. It is intended to be used by qualified medical professionals, such as physicians, nurses, and respiratory therapists. ","201001587 201001594 100066488 100017106 100017114 100017223 100017224 100017230 100017234 100006282 100078254 100078560 100078563 100080057 100013022 100004544 100013661 100013664 100013472 100013658 100042656 100049569 100005498 100014349 100014422 100014430 100014432 100014436 100014438 100014439 100014640 100014643 100014644 100014935 100014936 100014938 100014939 100015003 100082002 100082006 100082083 100082084 100045123 100045295 100030471 100030479 100030484 100030602 100034394 100034398 100034584 100034587 100041191 100014350 100025026 100025032 100025927 100025929 100025930 100025943 100025993 100025994 100025999 201001894 100057883 100057980 100035420 100035575 100035733 201002953 100082192 100082207 100082208 100042116 100021037 100021042 201001495 201001501 100072453 100073915 100037767 100037873 100038506 100038513 100038519 100038807 100038809 100038812 100038925 100038933 100038937 100038944 100038946 100038947 100040748 201003324 100040752 100009963 100009972 100010387 100010388 100044617 100044774 100044791 100066222 100066562 100031574 100081553 100081853 100016549 100016578 100009088 100010389 201000065 201002801 201002865 100003757 100003007 100016742 100016744 100028853 100003052 100005251 201000313 100065694 100065699 100009248 100009250 100009333 100009502 100028463 201000948 201000953 100038426 100038518 100038704 100014642 100035346 100035347 201002945 201002946 201002947 100035614 100035743 100038932 100040301 100038709 100049294 100049389 100049390 100049572 100049574 100049697 100049702 100028947 100012269 100012283 100012287 100012288 100012354 100012355 100012356 100012357 100015514 100015515 100015517 100040179 100040190 100040303 100040304 100040307 100064248 100064236 100012874 201001300 100048641 201000381 100078511 100078518 100078519 100078523 100078524 100078527 100012473 100012705 100012767 201001845 201001846 100065226 100065232 201003213 100049920 100050648 100050653 100082637 100082657 201001104 100007707 100009676 100009813 100009815 100009818 100009909 201002553 10004"," 100075767 100075768 100075769 100075770 100075772 100075773 100075774 100075776 100075822 100075823 100075824 100075825 100075826 100075827 100075828 100075829 100075830 100075834 100075901 100079001 100079004 100079006 100079008 100079011 100079016 100079017 100079019 100079020 100079021 100079022 100079023 100079025 100079027 100079028 100079199 100079200 100079201 100079202 100079203 100079204 100079205 100079206 100079208 100079212 100078520 100079326 100079329 100079330 100079331 100079332 100079333 100079341 100079342 100079344 100079455 100079456 100079457 100079458 100079462 100079463 100079464 100079466 100079467 100079468 100079469 100079475 100079479 100079481 100079558 100014142 100014286 100026618 100026807 201002443 100048880 100051215 100047380 100047387 100047395 100047403 100047555 100038706 100040160 100040162 100040169 100040178 100040182 201000591 100005495 100006377 201000589 100006367 100006378 100003911 100005596 100006283 100006287 100006376 100006382 100006383 100006393 100006398 100020213 100020306 100020442 100020881 100020891 100020940 100021140 100021142 100021148 201001606 201001610 201001667 201001670 201001704 201001726 201001734 201001755 201001761 201002118 201002119 201002141 201002142 201002144 201002146 201002149 201002151 201002152 201002180 201002181 201002182 201002186 201002187 201002188 201002190 100031572 100031573 100031575 100031576 100031665 100031667 100031672 100031673 100031675 100031677 201002803 201002804 201002814 201002818 201002820 201002824 201002825 100037863 100038025 100038028 100038029 100038039 100038044 100038045 100038046 100040734 100040751 100040753 100040860 100040861 100040863 100040864 100040866 100040869 100040872 100040873 100040980 100040985 100040986 100040998 100041048 100041055 100041057 100041060 100041061 100041063 100041064 100041066 100041067 100041068 100041074 100041135 100041139 100041142 100041144 100041145 100041146 100041148 100041149 100041152 100041193 100041205 100041206 100042013 100042017 100042105 100042112 100042113 1000","19,200 units total (12,060 units in US)","Respironics California, Inc. has initiated a recall on the V60 ventilator because of an issue with the software on the V60 Power Management Board Assembly. If a component fails on the Power Management Board Assembly, it may cause ventilator support to be lost with potentially no audible alarm from the ventilator. ",6/4/2013,"06/04/2013",6/26/2013,"06/26/2013"
"Devices",65377,"Ongoing","Beckman Coulter Inc.","Brea","CA","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution - USA Nationwide and country of Canada.","Z-1613-2013","Class II","Synchron System(s) Lactate Reagent Product Usage: Lactate (LACT) reagent, when used in conjunction with Synchron LX System(s), UniCel DxC 600/800 System(s) and Synchron Systems Multi Calibrator, is intended for the quantitative determination of lactate concentration in human plasma and cerebrospinal fluid (CSF).","Part Number A95550, Lot Number M210077",,"3,353 units","Beckman Coulter has confirmed customer reports of LACT Lot M210077 failing calibration with error condition OCR LOW. The calibration failures appear to be related to improper shipping or storage conditions (frozen reagent). Failed calibration of LACT may cause a delay in reporting results.",5/28/2013,"05/28/2013",7/3/2013,"07/03/2013"
"Food",65378,"Ongoing","Cheryls","Westerville","OH","US","Voluntary: Firm Initiated","press release","The product has been distibuted to 13 military members in Europe and the Pacific regions, as well as customers in these states: AK, AL, AR, AZ, CA, CO, CT, Washington DC, DE, FL, GA, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, TN, TX, UT, VA, VT, WA, WI, WV, WY.","F-1577-2013","Class II","Fudge Buttercream Frosted Peanut Butter cookies, some of which were mislabeled by being wrapped in Buttercream Frosted Cinnamon Pumpkin cookie wrappers, 1.6oz (45g) in size, 1 cookie per package, 100 cookies per case. ","Lot number 88 13 1",".","10588","Undeclared allergen due to use of incorrect packaging on peanut butter cookies. ",5/30/2013,"05/30/2013",7/10/2013,"07/10/2013"
"Devices",65379,"Ongoing","GE Healthcare, LLC","Waukesha","WI","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution - USA Nationwide including the states of: AL, AK, AZ, AR, CA, CO, CT, DC, FL, GA, ID, IL, IN, IA, KS, KY, IA, ME, MD,MA, MI, MN, MS, MO, MT, NE,NV,NH, NJ, NM, NY, NC, OR, OK OH, PA, PR, SC, TN, TX, UT, VA, WA, WY, WI, WY, and the countries of: ARGENTINA, AUSTRALIA, AUSTRIA, BAHRAIN, BELGIUM, BRAZIL, CANADA, CHILE, COLOMBIA, COSTA RICA, CYPRUS, CZECH REPUBLIC, DENMARK,, EGYPT, ESTONIA, FINLAND, FRANCE, GERMANY, HONG KONG, INDIA, IRAQ, ISRAEL, ITALY, JAPAN, KOREA, KUWAIT, LEBANON, LITHUANIA, MALAYSIA, MALTA, MEXICO, NETHERLAND, NEW ZEALAND, NORWAY, PANAMA, PERU, POLAND, PORTUGAL, QATAR, SAUDI ARABIA, SINGAPORE, SLOVAKIA, SLOVENIA, SOUTH AFRICA, SPAIN, SWEDEN, SWITZERLAND, TAIWAN, THAILAND, TUNISIA, TURKEY, UNITED ARAB EMIRATES, UNITED KINGDOM, URUGUAY.","Z-1567-2013","Class II","CARESCAPE Monitor B850 Product Usage: The CARESCAPE TM Monitor B850 is a multi-parameter high acuity patient monitor intended for use in multiple areas within a professional healthcare facility on adult, pediatric, and neonatal patients and on one patient at a time. The system is indicated for monitoring of Hemodynamics, Airway Gases (Fi/Et CO2, O2, N2) and Anesthetic Agent), Spirometry, Gas Exchange (O2 Consumption (VO2), CO2 production (VCO2), energy expenditure (EE), and respiratory quotient (RQ)) and neurophysiological (including electroencephalography (EEG), Entropy, Bispectral Index (BIS) and Neuromuscular Transmission (NMT) Monitoring) status. It is a stand-alone monitor or interfaced to other devices. is designed to provide configuration and troubleshooting capabilities to qualified service personnel. The CARESCAPE Monitor B850 is not intended for use during MRI.","Mfg Lot or Serial # SED11107648GA SED11107652GA SED11117927GA SED11117959GA SED11168563GA SED10293123GA SED10293124GA SED10353742GA SED10353743GA SED10132473GA SED10303335GA SED10333640GA SED11178619GA SED10142532GA SED10485114GA SED09340621GA SED09340629GA SED09340640GA SED09340654GA SED09340655GA SED09471473GA SED10021715GA SED10021720GA SED10041824GA SED10112150GA SED10112155GA SED10112156GA SED10112165GA SED10112173GA SED10112199GA SED10122287GA SED10122288GA SED10122291GA SED10122297GA SED10122314GA SED10122331GA SED10122332GA SED10122334GA SED10122335GA SED09090248GP SED09130299GP SED09130301GP SED09130304GP SED09130308GP SED09130309GP SED09130310GP SED09130313GP SED09491635GA SED10505510GA SED11067055GA SED11077158GA SED11077165GA SED11087325GA SED11087333GA SED11087361GA SED11097434GA SED11097448GA SED11097449GA SED11097455GA SED11097498GA SED11097532GA SED11097536GA SED11097543GA SED11097546GA SED11097547GA SED11097548GA SED11097549GA SED11097550GA SED11097583GA SED11097584GA SED11097586GA SED11097587GA SED11097588GA SED11097605GA SED11097608GA SED11107621GA SED11107643GA SED11107664GA SED11107720GA SED11107747GA SED11107751GA SED11107767GA SED11107770GA SED11107780GA SED11117928GA SED11117932GA SED11117942GA SED11117943GA SED11128168GA SED11138226GA SED11138229GA SED11138241GA SED11138280GA SED11138286GA SED11138291GA SED11138292GA SED11138293GA SED11148304GA SED11148312GA SED11148328GA SED11148330GA SED11148360GA SED11158467GA SED11158469GA SED11158487GA SED11158546GA SED11178637GA SED11178638GA SED11178763GA SED11209189GA SED11209203GA SED11229449GA SED11229557GA SED11229558GA SED11229562GA SED11300276GA SED11300278GA SED11300293GA SED11310421GA SED11330608GA SED11330642GA SED11330644GA SED11340655GA SED11441024GA SED11441025GA SED11451048GA SED12011208GA SED12011227GA SED12011235GA SED12021259GA SED12051638GA SED12051640GA SED12051649GA SED12051653GA SED12051656GA SED12051667GA SED12051669GA SED12051671GA SED12051673GA SED12051674GA SED12051679GA SED12051680GA SED12051691GA SED12051695GA SED120516"," SED10222839GA SED10222840GA SED10222841GA SED10222842GA SED09441263GA SED09441285GA SED09471419GA SED10526280GA SED10526286GA SED09370743GA SED09370823GA SED09370831GA SED09390848GA SED09400938GA SED09441262GA SED09441266GA SED09441271GA SED09441276GA SED09441278GA SED09441279GA SED09441284GA SED09441290GA SED09441293GA SED09451299GA SED09451306GA SED09451321GA SED10353754GA SED10353755GA SED10353756GA SED10353757GA SED10353758GA SED10353759GA SED10353760GA SED10353761GA SED10424427GA SED10424431GA SED10424432GA SED10424433GA SED10424434GA SED10424435GA SED10495300GA SED10505443GA SED10505512GA SED10505625GA SED10505626GA SED10505660GA SED10505661GA SED10536393GA SED10536394GA SED10536429GA SED10536431GA SED10536434GA SED10536437GA SED10536439GA SED10536442GA SED10536443GA SED10536444GA SED10536445GA SED10536447GA SED10536448GA SED10536450GA SED10536457GA SED10536459GA SED10536464GA SED10536470GA SED10536473GA SED10536474GA SED10536475GA SED10536476GA SED10536477GA SED10536480GA SED10536481GA SED10536482GA SED10536484GA SED10536486GA SED10536491GA SED10536492GA SED10536494GA SED10536498GA SED10536499GA SED10536505GA SED10536519GA SED11026563GA SED11026564GA SED11026568GA SED11026570GA SED11036585GA SED11036586GA SED11036587GA SED11036588GA SED11036589GA SED11036609GA SED11036610GA SED11036611GA SED11036618GA SED11036619GA SED11036620GA SED11036621GA SED11036622GA SED11036627GA SED11036658GA SED11036660GA SED11036662GA SED11036668GA SED11036675GA SED11036686GA SED11036688GA SED11036706GA SED11067087GA SED11067086GA SED11067080GA SED11067082GA SED11067085GA SED11057064GA SED11067081GA SED10505572GA SED11026544GA SED11026536GA SED11026562GA SED11026559GA SED11026534GA SED11026550GA SED11026567GA SED10536488GA SED11026546GA SED10536455GA SED11026549GA SED10505591GA SED10505631GA SED10505624GA SED10505653GA SED10505558GA SED10505629GA SED10505618GA SED10505584GA SED10505630GA SED10414314GA SED10414315GA SED10424465GA SED10424466GA SED10424467GA SED10424468GA SED10424469GA SED10424470GA SED10495336GA SED10495337GA ","12,779","GE Healthcare become aware of 4 potential issues associated with the CARESCAPE Monitor B850. These issues include CARESCAPE Monitor B850 uDOM failure, CARESCAPE Monitor B850 unstable USB communication, CARESCAPE Monitor B850 remote printing issue with currently printing PRN 50 recorder and CARESCAPE Monitor B850 reboots due to an X server freeze.",7/20/2012,"07/20/2012",7/3/2013,"07/03/2013"
"Devices",65380,"Ongoing","Terumo Cardiovascular Systems Corporation","Ann Arbor","MI","US","Voluntary: Firm Initiated",,"Worldwide Distribution - US Nationwide in the states of :AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, ID, IL, IN, KY, LA, MA, MD, ME, MI, MN, MO, MSMT, NC, ND, NE, NJ, NM, NV, NY, OH, OK, OR, PA, SC, TN, TX, UT, VA, VT, WA, WI, WV and countries of AUSTRALIA, UNITED ARAB EMIRATES (UAE),Hong Kong,Indonesia, Singapore, Taiwan, Thailand,Philippines, CHILE,Malaysia, South Korea, BELGIUM,Japan,Mexico,CANADA","Z-1977-2013","Class II","100/120V AC, Advanced Perfusion System 1 Product Usage: The Terumo Advanced Perfusion System 1 is indicated for use in extracorporeal circulation of blood for arterial perfusion, regional perfusion, and cardiopulmonary bypass procedures only when used by a qualified perfusionist who is experienced in the operation of Sarns TM or similar equipment. ","Catalog number: 801763",,"1657","TCVS is taking action to update the Operators Manual with the specific instructions to respond to this condition and will issue a labeling addendum for current users. In the event of a false high pressure alarm condition occurs that displays a ''999'' pressure reading and results in stopping a pump, this pressure display can be cleared and the pump re-started by disconnecting the pressure transducer from the system.",7/26/2013,"07/26/2013",8/21/2013,"08/21/2013"
"Devices",65380,"Ongoing","Terumo Cardiovascular Systems Corporation","Ann Arbor","MI","US","Voluntary: Firm Initiated",,"Worldwide Distribution - US Nationwide in the states of :AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, ID, IL, IN, KY, LA, MA, MD, ME, MI, MN, MO, MSMT, NC, ND, NE, NJ, NM, NV, NY, OH, OK, OR, PA, SC, TN, TX, UT, VA, VT, WA, WI, WV and countries of AUSTRALIA, UNITED ARAB EMIRATES (UAE),Hong Kong,Indonesia, Singapore, Taiwan, Thailand,Philippines, CHILE,Malaysia, South Korea, BELGIUM,Japan,Mexico,CANADA","Z-1978-2013","Class II","100/120V AC, Advanced Perfusion System 1 Product Usage: The Terumo Advanced Perfusion System 1 is indicated for use in extracorporeal circulation of blood for arterial perfusion, regional perfusion, and cardiopulmonary bypass procedures only when used by a qualified perfusionist who is experienced in the operation of Sarns TM or similar equipment. ","Catalog number: 801764",,"1657","TCVS is taking action to update the Operators Manual with the specific instructions to respond to this condition and will issue a labeling addendum for current users. In the event of a false high pressure alarm condition occurs that displays a ''999'' pressure reading and results in stopping a pump, this pressure display can be cleared and the pump re-started by disconnecting the pressure transducer from the system.",7/26/2013,"07/26/2013",8/21/2013,"08/21/2013"
"Devices",65381,"Ongoing","Terumo Cardiovascular Systems Corporation","Ann Arbor","MI","US","Voluntary: Firm Initiated",,"Worlwide Distribution - US Nationwide: AL,AR,AZ, CA, CO, CT, DC, DE, FL,GA, HI, IA, ID, IL, IN, KY, LA, MA , MD, MI, MN, MO, MS, MT, NC, ND, NE, NJ, NM, NV, NY, OH, OK, OR, PA, SC, TN, TX, UT, VA, VT, WA, WI, WV and the countries of: AUSTRALIA,UNITED ARAB EMIRATES (UAE),Hong Kong, onesia,Singapore,Taiwan,Thailand, Philippines,CHILE, Malaysia,USA,South Korea,BELGIUM,Japan,Mexico,CANADA","Z-1974-2013","Class II","Terumo Advanced Perfusion System 1 (APS1, System 1) Description: 220/240V AC Product Usage: The Terumo Advanced Perfusion System 1 is indicated for use in extracorporeal circulation of blood for arterial perfusion, regional perfusion, and cardiopulmonary bypass procedures only when used by a qualified perfusionist who is experienced in the operation of Sarns TM or similar equipment. ","Catalog Number or Part Number: 801764 Description: 220/240V AC, Advanced Perfusion System 1 ",,"1657 ","Terumo Cardiovascular Systems (TCVS) has become aware that an Advanced Perfusion System 1 (APS1) Centrifugal Pump 'Service Pump' message may occur due to user induced motor movement. In this instance, the APS1 will identify the movement (as it is designed) and display a Service Pump message error. The user might interpret this as a pump which requires service rather than a message displayed due to pump movement while not activated.",7/26/2013,"07/26/2013",8/21/2013,"08/21/2013"
"Devices",65381,"Ongoing","Terumo Cardiovascular Systems Corporation","Ann Arbor","MI","US","Voluntary: Firm Initiated",,"Worlwide Distribution - US Nationwide: AL,AR,AZ, CA, CO, CT, DC, DE, FL,GA, HI, IA, ID, IL, IN, KY, LA, MA , MD, MI, MN, MO, MS, MT, NC, ND, NE, NJ, NM, NV, NY, OH, OK, OR, PA, SC, TN, TX, UT, VA, VT, WA, WI, WV and the countries of: AUSTRALIA,UNITED ARAB EMIRATES (UAE),Hong Kong, onesia,Singapore,Taiwan,Thailand, Philippines,CHILE, Malaysia,USA,South Korea,BELGIUM,Japan,Mexico,CANADA","Z-1973-2013","Class II","Terumo Advanced Perfusion System 1 (APS1, System 1) 100/120V AC Product Usage: The Terumo Advanced Perfusion System 1 is indicated for use in extracorporeal circulation of blood for arterial perfusion, regional perfusion, and cardiopulmonary bypass procedures only when used by a qualified perfusionist who is experienced in the operation of Sarns TM or similar equipment. ","Catalog Number or Part Number: 801763 Description: 100/120V AC, Advanced Perfusion System 1 ",,"1657 total","Terumo Cardiovascular Systems (TCVS) has become aware that an Advanced Perfusion System 1 (APS1) Centrifugal Pump 'Service Pump' message may occur due to user induced motor movement. In this instance, the APS1 will identify the movement (as it is designed) and display a Service Pump message error. The user might interpret this as a pump which requires service rather than a message displayed due to pump movement while not activated.",7/26/2013,"07/26/2013",8/21/2013,"08/21/2013"
"Biologics",65384,"Terminated","LifeSouth Community Blood Centers, Inc.","Gainesville","FL","US","Voluntary: Firm Initiated","FAX","Florida","B-2076-13","Class II","Platelets Pheresis Leukocytes Reduced","W115113080709L; W115113080709L; ",,"2","Blood products, collected from a donor whose suitability to donate was not adequately determined, were distributed.",4/1/2013,"04/01/2013",9/4/2013,"09/04/2013"
"Biologics",65385,"Terminated","Lifesouth Community Blood Centers - Montgomery Region","Montgomery","AL","US","Voluntary: Firm Initiated","FAX","Alabama","B-1780-13","Class III","Red Blood Cells Leukocytes Reduced Irradiated","W115113098152E; ",,"1","Blood product, labeled with an extended expiration date, was distributed.",3/20/2013,"03/20/2013",9/4/2013,"09/04/2013"
"Biologics",65386,"Terminated","International Sight Restoration, Inc.","Tampa","FL","US","Voluntary: Firm Initiated","E-Mail","Israel and Florida","B-2023-13","Class III","Cornea","20110009OD, 20110009OS",,"2 corneas","Human corneas, recovered from a donor whose donor eligibility determination failed to ensure that the donor was free from risk factors for, and clinical evidence of infection due to relevant communicable disease agents and diseases, were distributed. ",6/5/2013,"06/05/2013",8/7/2013,"08/07/2013"
"Biologics",65387,"Terminated","LifeSouth Community Blood Centers, Inc.","Gainesville","FL","US","Voluntary: Firm Initiated","FAX","Georgia","B-2100-13","Class II","Platelets Pheresis","W115113072408A; W115113072408A; ",,"2","Blood products, labeled leukoreduced which had not undergone leukoreduction, were distributed.",3/28/2013,"03/28/2013",9/4/2013,"09/04/2013"
"Biologics",65388,"Terminated","Lifesouth Community Blood Centers, Inc. - Mobile Region","Mobile","AL","US","Voluntary: Firm Initiated","FAX","Alabama","B-2125-13","Class II","Red Blood Cells (Apheresis) Leukocytes Reduced","W115113088151B; W115113088151B; ",,"2","Blood products, collected without the performance of a WBC count during instrument re-validation, were distributed.",3/26/2013,"03/26/2013",9/4/2013,"09/04/2013"
"Biologics",65389,"Terminated","LifeShare Community Blood Services","Elyria","OH","US","Voluntary: Firm Initiated","Telephone","Ohio","B-2126-13","Class III","Fresh Frozen Plasma (Apheresis)","W043813700005; W043813700005; W043813700005; ",,"3","Blood products, collected in an expired triple transfer pack, were distributed. ",4/15/2013,"04/15/2013",9/4/2013,"09/04/2013"
"Biologics",65390,"Terminated","LifeSouth Community Blood Centers Inc - Birmingham Region","Birmingham","AL","US","Voluntary: Firm Initiated","FAX","Alabama","B-2127-13","Class II","Platelets Pheresis Leukocytes Reduced","W115113056447X; ",,"1","Blood product, with platelet count below the specified minimum requirement, was distributed.",3/7/2013,"03/07/2013",9/4/2013,"09/04/2013"
"Devices",65391,"Ongoing","Advanced Orthogonal Equipment, Incorporated","Saint Petersburg","FL","US","Voluntary: Firm Initiated","Letter","Nationwide distribution: US including states of: AL, CA, CO, FL, GA, ID, KY, MD, NC, NJ, NY, OH, PA, TN, VA, and WA.","Z-1809-2013","Class II","Advanced Orthogonal Percussion Adjusting Instrument Indicated for use by a licensed Chiropractor to assist in making Chiropractic adjustments to the Atlas vertebra.","Serial numbers: 001, 002, 008, 007, 006, 0010, 009, 011, 016, 015, 014, 023, 017, 018, 019, 020, 021, 024, 025, 022, 027, 026, 028, 029, 030, 031, 032, 033, 034, 035, 036, 038, 039, 037, 041, 042, 040, 043, 044, 045, 046, 048, 049, 050, 052, 053, 055, 056, 060, 058, 059, and 061",,"54","Unapproved medical device",3/6/2013,"03/06/2013",7/31/2013,"07/31/2013"
"Food",65392,"Ongoing","Lipari Foods, Inc.","Warren","MI","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Ohio, Michigan, West Virginia, Kentucky, Tennessee, Pennsylvania, Wisconsin, Illinois, and Indiana.","F-1660-2013","Class I","Item Number: 192772 Item Description: BAG CLR SUNFLOWER R/SEA SALT Case Pack: 12 Package Size: 11 OZ Clear Plastic Bag (Pic-A-Nut Label on Front, Nutritional Label on Back) UPC Number: 070207018849 ","Lot Number: 23201305 Best By Date: 5/23/2014 ",".","193 cases","Contamination with Listeria monocytogenes, an organism which can cause serious and sometimes fatal infections in young children, frail or elderly people, and others with weakened immune systems. Although healthy individuals may suffer only short-term symptoms such as high fever, severe headache, stiffness, nausea, abdominal pain and diarrhea, Listeria infection can cause miscarriages and stillbirths among pregnant women.",6/4/2013,"06/04/2013",7/17/2013,"07/17/2013"
"Food",65392,"Ongoing","Lipari Foods, Inc.","Warren","MI","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Ohio, Michigan, West Virginia, Kentucky, Tennessee, Pennsylvania, Wisconsin, Illinois, and Indiana.","F-1662-2013","Class I","Item Number: 192874 Item Description: BAG CLR SUNFLOWER MEAT W/SLT Case Pack: 12 Package Size: 7 OZ Clear Plastic Bag (Pic-A-Nut Label on Front, Nutritional Label on Back) UPC Number: 070207000424 ","Lot Number: 15201304 Best By Date: 4/15/2014 ",".","127 cases","Contamination with Listeria monocytogenes, an organism which can cause serious and sometimes fatal infections in young children, frail or elderly people, and others with weakened immune systems. Although healthy individuals may suffer only short-term symptoms such as high fever, severe headache, stiffness, nausea, abdominal pain and diarrhea, Listeria infection can cause miscarriages and stillbirths among pregnant women.",6/4/2013,"06/04/2013",7/17/2013,"07/17/2013"
"Food",65392,"Ongoing","Lipari Foods, Inc.","Warren","MI","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Ohio, Michigan, West Virginia, Kentucky, Tennessee, Pennsylvania, Wisconsin, Illinois, and Indiana.","F-1669-2013","Class I","Item Number: 193078 Item Description: BAGS SM SUNFLOWER SHELLED R/S Case Pack: 12 Package Size: 4 OZ Fully Preprinted Old Style Pic-A-Nut Bag UPC Number: 070207029029 ","Lot Number: 23201305 Best By Date: 5/23/2014 ",".","87 cases","Contamination with Listeria monocytogenes, an organism which can cause serious and sometimes fatal infections in young children, frail or elderly people, and others with weakened immune systems. Although healthy individuals may suffer only short-term symptoms such as high fever, severe headache, stiffness, nausea, abdominal pain and diarrhea, Listeria infection can cause miscarriages and stillbirths among pregnant women.",6/4/2013,"06/04/2013",7/17/2013,"07/17/2013"
"Food",65392,"Ongoing","Lipari Foods, Inc.","Warren","MI","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Ohio, Michigan, West Virginia, Kentucky, Tennessee, Pennsylvania, Wisconsin, Illinois, and Indiana.","F-1670-2013","Class I","Item Number: 193095 Item Description: BAGS LG SESAME STIX HONEY Case Pack: 12 Package Size: 4.5 OZ Fully Preprinted New Style Pic-A-Nut Bag UPC Number: 070207004484 ","Lot Numbers: 15201304, 23201305 Best By Dates: 4/15/2014, 5/23/2014 ",".","200 cases","Contamination with Listeria monocytogenes, an organism which can cause serious and sometimes fatal infections in young children, frail or elderly people, and others with weakened immune systems. Although healthy individuals may suffer only short-term symptoms such as high fever, severe headache, stiffness, nausea, abdominal pain and diarrhea, Listeria infection can cause miscarriages and stillbirths among pregnant women.",6/4/2013,"06/04/2013",7/17/2013,"07/17/2013"
"Food",65392,"Ongoing","Lipari Foods, Inc.","Warren","MI","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Ohio, Michigan, West Virginia, Kentucky, Tennessee, Pennsylvania, Wisconsin, Illinois, and Indiana.","F-1681-2013","Class I","Item Number: 196325 Item Description: BAG CLR ALMOND SLIVERED Case Pack: 12 Package Size: 9 OZ Clear Plastic Bag (Pic-A-Nut Label on Front, Nutritional Label on Back) UPC Number: 070207000127 ","Lot Number: 06201306 Best By Date: 6/6/2014 ",".","73 cases","Contamination with Listeria monocytogenes, an organism which can cause serious and sometimes fatal infections in young children, frail or elderly people, and others with weakened immune systems. Although healthy individuals may suffer only short-term symptoms such as high fever, severe headache, stiffness, nausea, abdominal pain and diarrhea, Listeria infection can cause miscarriages and stillbirths among pregnant women.",6/4/2013,"06/04/2013",7/17/2013,"07/17/2013"
"Food",65392,"Ongoing","Lipari Foods, Inc.","Warren","MI","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Ohio, Michigan, West Virginia, Kentucky, Tennessee, Pennsylvania, Wisconsin, Illinois, and Indiana.","F-1696-2013","Class I","Item Number: 368712 Item Description: TUB MD GOOD & PLENTY Case Pack: 12 Package Size: 16 OZ 2-Piece Clear Plastic Tub (No Label on Top, Nutritional Label on Bottom) UPC Number: 094776110032 ","Lot Number: 30201305 Best By Date: 05/30/2014 ",".","75 cases ","Contamination with Listeria monocytogenes, an organism which can cause serious and sometimes fatal infections in young children, frail or elderly people, and others with weakened immune systems. Although healthy individuals may suffer only short-term symptoms such as high fever, severe headache, stiffness, nausea, abdominal pain and diarrhea, Listeria infection can cause miscarriages and stillbirths among pregnant women.",6/4/2013,"06/04/2013",7/17/2013,"07/17/2013"
"Food",65392,"Ongoing","Lipari Foods, Inc.","Warren","MI","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Ohio, Michigan, West Virginia, Kentucky, Tennessee, Pennsylvania, Wisconsin, Illinois, and Indiana.","F-1675-2013","Class I","Item Number: 193673 Item Description: BAGS SM PEPITA SEEDS R/S Case Pack: 12 Package Size: 1.75 OZ Fully Preprinted New Style Pic-A-Nut Bag UPC Number: 070207025106 ","Lot Number: 23201305 Best By Date: 5/23/2014 ",".","67 cases","Contamination with Listeria monocytogenes, an organism which can cause serious and sometimes fatal infections in young children, frail or elderly people, and others with weakened immune systems. Although healthy individuals may suffer only short-term symptoms such as high fever, severe headache, stiffness, nausea, abdominal pain and diarrhea, Listeria infection can cause miscarriages and stillbirths among pregnant women.",6/4/2013,"06/04/2013",7/17/2013,"07/17/2013"
"Food",65392,"Ongoing","Lipari Foods, Inc.","Warren","MI","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Ohio, Michigan, West Virginia, Kentucky, Tennessee, Pennsylvania, Wisconsin, Illinois, and Indiana.","F-1661-2013","Class I","Item Number: 192806 Item Description: BAG CLR PUMPKIN SD R/SEA SALT Case Pack: 12 Package Size: 9 OZ Clear Plastic Bag (Pic-A-Nut Label on Front, Nutritional Label on Back) UPC Number: 070207018832 ","Lot Number: 23201305 Best By Date: 5/23/2014 ",".","107 cases","Contamination with Listeria monocytogenes, an organism which can cause serious and sometimes fatal infections in young children, frail or elderly people, and others with weakened immune systems. Although healthy individuals may suffer only short-term symptoms such as high fever, severe headache, stiffness, nausea, abdominal pain and diarrhea, Listeria infection can cause miscarriages and stillbirths among pregnant women.",6/4/2013,"06/04/2013",7/17/2013,"07/17/2013"
"Food",65392,"Ongoing","Lipari Foods, Inc.","Warren","MI","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Ohio, Michigan, West Virginia, Kentucky, Tennessee, Pennsylvania, Wisconsin, Illinois, and Indiana.","F-1677-2013","Class I","Item Number: 193843 Item Description: BAGS SM ALMONDS SLICED RAW Case Pack: 12 Package Size: 1.75 OZ Fully Preprinted Old Style Pic-A-Nut Bag UPC Number: 070207018351 ","Lot Numbers: 08201304, 03201306, 06201306 Best By Dates: 4/8/2014, 6/3/2014, 6/6/2014 ",".","100 cases","Contamination with Listeria monocytogenes, an organism which can cause serious and sometimes fatal infections in young children, frail or elderly people, and others with weakened immune systems. Although healthy individuals may suffer only short-term symptoms such as high fever, severe headache, stiffness, nausea, abdominal pain and diarrhea, Listeria infection can cause miscarriages and stillbirths among pregnant women.",6/4/2013,"06/04/2013",7/17/2013,"07/17/2013"
"Food",65392,"Ongoing","Lipari Foods, Inc.","Warren","MI","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Ohio, Michigan, West Virginia, Kentucky, Tennessee, Pennsylvania, Wisconsin, Illinois, and Indiana.","F-1687-2013","Class I","Item Number: 333803 Item Description: TUB SM PISTACHIO MEAT RAW Case Pack: 12 Package Size: 9 OZ 2-Piece Clear Plastic Tub (No Label on Top, Nutritional Label on Bottom) UPC Number: 760208123818 ","Lot Numbers: 23201305, 24201305 Best By Dates: 05/23/2014, 05/24/2014 ",".","144 cases","Contamination with Listeria monocytogenes, an organism which can cause serious and sometimes fatal infections in young children, frail or elderly people, and others with weakened immune systems. Although healthy individuals may suffer only short-term symptoms such as high fever, severe headache, stiffness, nausea, abdominal pain and diarrhea, Listeria infection can cause miscarriages and stillbirths among pregnant women.",6/4/2013,"06/04/2013",7/17/2013,"07/17/2013"
"Food",65392,"Ongoing","Lipari Foods, Inc.","Warren","MI","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Ohio, Michigan, West Virginia, Kentucky, Tennessee, Pennsylvania, Wisconsin, Illinois, and Indiana.","F-1699-2013","Class I","Item Number: 373703 Item Description: TUB LG ALMOND ROASTED N/SLT Case Pack: 12 Package Size: 15 OZ 2-Piece Clear Plastic Tub (No Label on Top, Nutritional Label on Bottom) UPC Number: 094776076116 ","Lot Number: 01201305 Best By Date: 05/01/2014 ",".","125 cases","Contamination with Listeria monocytogenes, an organism which can cause serious and sometimes fatal infections in young children, frail or elderly people, and others with weakened immune systems. Although healthy individuals may suffer only short-term symptoms such as high fever, severe headache, stiffness, nausea, abdominal pain and diarrhea, Listeria infection can cause miscarriages and stillbirths among pregnant women.",6/4/2013,"06/04/2013",7/17/2013,"07/17/2013"
"Food",65392,"Ongoing","Lipari Foods, Inc.","Warren","MI","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Ohio, Michigan, West Virginia, Kentucky, Tennessee, Pennsylvania, Wisconsin, Illinois, and Indiana.","F-1684-2013","Class I","Item Number: 204145 Item Description: TUB PAN MD CASHEW JUMBO N/S Case Pack: 12 Package Size: 10 OZ 2-Piece Clear Plastic Tub (Pic-A-Nut Label on Top, Nutritional Label on Bottom) UPC Number: 070207005061 ","Lot Number: 30201305 Best By Date: 05/30/2014 ",".","147 cases","Contamination with Listeria monocytogenes, an organism which can cause serious and sometimes fatal infections in young children, frail or elderly people, and others with weakened immune systems. Although healthy individuals may suffer only short-term symptoms such as high fever, severe headache, stiffness, nausea, abdominal pain and diarrhea, Listeria infection can cause miscarriages and stillbirths among pregnant women.",6/4/2013,"06/04/2013",7/17/2013,"07/17/2013"
"Food",65392,"Ongoing","Lipari Foods, Inc.","Warren","MI","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Ohio, Michigan, West Virginia, Kentucky, Tennessee, Pennsylvania, Wisconsin, Illinois, and Indiana.","F-1705-2013","Class I","Item Number: 461564 Item Description: TUB PL LG SUNFLOWER SEED RAW Case Pack: 12 Package Size: 14 OZ 2-Piece Clear Plastic Tub (Private Label on Top, Nutritional Label on Bottom) UPC Number: 094776081738 ","Lot Numbers: 09201304, 24201304, 01201305, 20201305, 30201305 Best By Dates: 4/9/2014, 4/24/2014, 5/1/2014, 5/20/2014, 5/30/2014 ",".","64 cases","Contamination with Listeria monocytogenes, an organism which can cause serious and sometimes fatal infections in young children, frail or elderly people, and others with weakened immune systems. Although healthy individuals may suffer only short-term symptoms such as high fever, severe headache, stiffness, nausea, abdominal pain and diarrhea, Listeria infection can cause miscarriages and stillbirths among pregnant women.",6/4/2013,"06/04/2013",7/17/2013,"07/17/2013"
"Food",65392,"Ongoing","Lipari Foods, Inc.","Warren","MI","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Ohio, Michigan, West Virginia, Kentucky, Tennessee, Pennsylvania, Wisconsin, Illinois, and Indiana.","F-1700-2013","Class I","Item Number: 374103 Item Description: TUB LG ALMOND WHOLE RAW Case Pack: 12 Package Size: 15 OZ 2-Piece Clear Plastic Tub (No Label on Top, Nutritional Label on Bottom) UPC Number: 094776081820 ","Lot Number: 09201304 Best By Date: 4/9/2014 ",".","302 cases","Contamination with Listeria monocytogenes, an organism which can cause serious and sometimes fatal infections in young children, frail or elderly people, and others with weakened immune systems. Although healthy individuals may suffer only short-term symptoms such as high fever, severe headache, stiffness, nausea, abdominal pain and diarrhea, Listeria infection can cause miscarriages and stillbirths among pregnant women.",6/4/2013,"06/04/2013",7/17/2013,"07/17/2013"
"Food",65392,"Ongoing","Lipari Foods, Inc.","Warren","MI","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Ohio, Michigan, West Virginia, Kentucky, Tennessee, Pennsylvania, Wisconsin, Illinois, and Indiana.","F-1680-2013","Class I","Item Number: 196291 Item Description: BAGS SM WALNUT HALVES & PIECES Case Pack: 12 Package Size: 1 OZ Fully Preprinted Old Style Pic-A-Nut Bag UPC Number: 070207015121 ","Lot Number: 08201304 Best By Date: 4/8/2014 ",".","52 cases","Contamination with Listeria monocytogenes, an organism which can cause serious and sometimes fatal infections in young children, frail or elderly people, and others with weakened immune systems. Although healthy individuals may suffer only short-term symptoms such as high fever, severe headache, stiffness, nausea, abdominal pain and diarrhea, Listeria infection can cause miscarriages and stillbirths among pregnant women.",6/4/2013,"06/04/2013",7/17/2013,"07/17/2013"
"Food",65392,"Ongoing","Lipari Foods, Inc.","Warren","MI","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Ohio, Michigan, West Virginia, Kentucky, Tennessee, Pennsylvania, Wisconsin, Illinois, and Indiana.","F-1694-2013","Class I","Item Number: 365172 Item Description: BAGS MIX CHERRY BERRY DELIGHT PP Case Pack: 12 Package Size: 9.5 OZ Clear Plastic Bag (Black Label on Front, Nutritional Label on Back) UPC Number: 094776110209 ","Lot Numbers: 08201304, 30201304 Best By Dates: 4/8/2014, 4/30/2014 ",".","63 cases","Contamination with Listeria monocytogenes, an organism which can cause serious and sometimes fatal infections in young children, frail or elderly people, and others with weakened immune systems. Although healthy individuals may suffer only short-term symptoms such as high fever, severe headache, stiffness, nausea, abdominal pain and diarrhea, Listeria infection can cause miscarriages and stillbirths among pregnant women.",6/4/2013,"06/04/2013",7/17/2013,"07/17/2013"
"Food",65392,"Ongoing","Lipari Foods, Inc.","Warren","MI","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Ohio, Michigan, West Virginia, Kentucky, Tennessee, Pennsylvania, Wisconsin, Illinois, and Indiana.","F-1701-2013","Class I","Item Number: 374903 Item Description: TUB LG MIXED NUTS DELUXE W/S Case Pack: 12 Package Size: 13 OZ 2-Piece Clear Plastic Tub (No Label on Top, Nutritional Label on Bottom) UPC Number: 094776081707 ","Lot Number: 24201304 Best By Date: 04/24/2014 ",".","161 cases","Contamination with Listeria monocytogenes, an organism which can cause serious and sometimes fatal infections in young children, frail or elderly people, and others with weakened immune systems. Although healthy individuals may suffer only short-term symptoms such as high fever, severe headache, stiffness, nausea, abdominal pain and diarrhea, Listeria infection can cause miscarriages and stillbirths among pregnant women.",6/4/2013,"06/04/2013",7/17/2013,"07/17/2013"
"Food",65392,"Ongoing","Lipari Foods, Inc.","Warren","MI","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Ohio, Michigan, West Virginia, Kentucky, Tennessee, Pennsylvania, Wisconsin, Illinois, and Indiana.","F-1667-2013","Class I","Item Number: 193044 Item Description: BAGS LG PECAN PIECES Case Pack: 12 Package Size: 4 OZ Fully Preprinted Old Style Pic-A-Nut Bag UPC Number: 070207016227 ","Lot Number: 08201304 Best By Date: 4/8/2014 ",".","122 cases","Contamination with Listeria monocytogenes, an organism which can cause serious and sometimes fatal infections in young children, frail or elderly people, and others with weakened immune systems. Although healthy individuals may suffer only short-term symptoms such as high fever, severe headache, stiffness, nausea, abdominal pain and diarrhea, Listeria infection can cause miscarriages and stillbirths among pregnant women.",6/4/2013,"06/04/2013",7/17/2013,"07/17/2013"
"Food",65392,"Ongoing","Lipari Foods, Inc.","Warren","MI","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Ohio, Michigan, West Virginia, Kentucky, Tennessee, Pennsylvania, Wisconsin, Illinois, and Indiana.","F-1691-2013","Class I","Item Number: 364926 Item Description: BAGS PEAS WASABI PP Case Pack: 12 Package Size: 10 OZ Clear Plastic Bag (Black Label on Front, Nutritional Label on Back) UPC Number: 094776110582 ","Lot Number: 08201304 Best By Date: 4/8/2014 ",".","78 cases","Contamination with Listeria monocytogenes, an organism which can cause serious and sometimes fatal infections in young children, frail or elderly people, and others with weakened immune systems. Although healthy individuals may suffer only short-term symptoms such as high fever, severe headache, stiffness, nausea, abdominal pain and diarrhea, Listeria infection can cause miscarriages and stillbirths among pregnant women.",6/4/2013,"06/04/2013",7/17/2013,"07/17/2013"
"Food",65392,"Ongoing","Lipari Foods, Inc.","Warren","MI","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Ohio, Michigan, West Virginia, Kentucky, Tennessee, Pennsylvania, Wisconsin, Illinois, and Indiana.","F-1673-2013","Class I","Item Number: 193333 Item Description: BAGS LG WALNUT HALVES & PIECES Case Pack: 12 Package Size: 6.5 OZ Fully Preprinted Old Style Pic-A-Nut Bag UPC Number: 070207015206 ","Lot Numbers: 08201304, 06201306 Best By Dates: 4/8/2014, 6/6/2014 ",".","48 cases","Contamination with Listeria monocytogenes, an organism which can cause serious and sometimes fatal infections in young children, frail or elderly people, and others with weakened immune systems. Although healthy individuals may suffer only short-term symptoms such as high fever, severe headache, stiffness, nausea, abdominal pain and diarrhea, Listeria infection can cause miscarriages and stillbirths among pregnant women.",6/4/2013,"06/04/2013",7/17/2013,"07/17/2013"
"Food",65392,"Ongoing","Lipari Foods, Inc.","Warren","MI","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Ohio, Michigan, West Virginia, Kentucky, Tennessee, Pennsylvania, Wisconsin, Illinois, and Indiana.","F-1703-2013","Class I","Item Number: 392103 Item Description: TUB LG CASHEW RAW WHOLE 320 Case Pack: 12 Package Size: 14 OZ 2-Piece Clear Plastic Tub (No Label on Top, Nutritional Label on Bottom) UPC Number: 760208124983 ","Lot Number: 09201304 Best By Date: 4/9/2014 ",".","162 cases","Contamination with Listeria monocytogenes, an organism which can cause serious and sometimes fatal infections in young children, frail or elderly people, and others with weakened immune systems. Although healthy individuals may suffer only short-term symptoms such as high fever, severe headache, stiffness, nausea, abdominal pain and diarrhea, Listeria infection can cause miscarriages and stillbirths among pregnant women.",6/4/2013,"06/04/2013",7/17/2013,"07/17/2013"
"Food",65392,"Ongoing","Lipari Foods, Inc.","Warren","MI","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Ohio, Michigan, West Virginia, Kentucky, Tennessee, Pennsylvania, Wisconsin, Illinois, and Indiana.","F-1674-2013","Class I","Item Number: 193435 Item Description: BAGS LG PUMPKIN SEEDS I/S R/S Case Pack: 12 Package Size: 7 OZ Fully Preprinted New Style Pic-A-Nut Bag UPC Number: 070207025151 ","Lot Number: 23201305 Best By Date: 5/23/2014 ",".","136 cases","Contamination with Listeria monocytogenes, an organism which can cause serious and sometimes fatal infections in young children, frail or elderly people, and others with weakened immune systems. Although healthy individuals may suffer only short-term symptoms such as high fever, severe headache, stiffness, nausea, abdominal pain and diarrhea, Listeria infection can cause miscarriages and stillbirths among pregnant women.",6/4/2013,"06/04/2013",7/17/2013,"07/17/2013"
"Food",65392,"Ongoing","Lipari Foods, Inc.","Warren","MI","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Ohio, Michigan, West Virginia, Kentucky, Tennessee, Pennsylvania, Wisconsin, Illinois, and Indiana.","F-1682-2013","Class I","Item Number: 201612 Item Description: BAGS SM PISTACHIO SHELLED R/S Case Pack: 12 Package Size: 0.75 OZ Fully Preprinted New Style Pic-A-Nut Bag UPC Number: 070207020217 ","Lot Numbers: 15201304, 23201305 Best By Dates: 4/15/2014, 5/23/2014 ",".","144 cases","Contamination with Listeria monocytogenes, an organism which can cause serious and sometimes fatal infections in young children, frail or elderly people, and others with weakened immune systems. Although healthy individuals may suffer only short-term symptoms such as high fever, severe headache, stiffness, nausea, abdominal pain and diarrhea, Listeria infection can cause miscarriages and stillbirths among pregnant women.",6/4/2013,"06/04/2013",7/17/2013,"07/17/2013"
"Food",65392,"Ongoing","Lipari Foods, Inc.","Warren","MI","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Ohio, Michigan, West Virginia, Kentucky, Tennessee, Pennsylvania, Wisconsin, Illinois, and Indiana.","F-1664-2013","Class I","Item Number: 192976 Item Description: BAG CLR SUNFLOWER MEAT RAW PP Case Pack: 12 Package Size: 7 OZ Clear Plastic Bag (Pic-A-Nut Label on Front, Nutritional Label on Back) UPC Number: 070207000202 ","Lot Numbers: 08201304, 15201304, 23201305, 03201306, 06201306 Best By Dates: 4/8/2014, 4/15/2014, 5/23/2014, 6/3/2014, 6/6/2014 ",".","109 cases","Contamination with Listeria monocytogenes, an organism which can cause serious and sometimes fatal infections in young children, frail or elderly people, and others with weakened immune systems. Although healthy individuals may suffer only short-term symptoms such as high fever, severe headache, stiffness, nausea, abdominal pain and diarrhea, Listeria infection can cause miscarriages and stillbirths among pregnant women.",6/4/2013,"06/04/2013",7/17/2013,"07/17/2013"
"Food",65392,"Ongoing","Lipari Foods, Inc.","Warren","MI","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Ohio, Michigan, West Virginia, Kentucky, Tennessee, Pennsylvania, Wisconsin, Illinois, and Indiana.","F-1683-2013","Class I","Item Number: 204128 Item Description: TUB PAN MD ALMOND ROASTED N/S Case Pack: 12 Package Size: 11 OZ 2-Piece Clear Plastic Tub (Pic-A-Nut Label on Top, Nutritional Label on Bottom) UPC Number: 070207005030 ","Lot Number: 30201305 Best By Date: 05/30/2014 ",".","172 cases","Contamination with Listeria monocytogenes, an organism which can cause serious and sometimes fatal infections in young children, frail or elderly people, and others with weakened immune systems. Although healthy individuals may suffer only short-term symptoms such as high fever, severe headache, stiffness, nausea, abdominal pain and diarrhea, Listeria infection can cause miscarriages and stillbirths among pregnant women.",6/4/2013,"06/04/2013",7/17/2013,"07/17/2013"
"Food",65392,"Ongoing","Lipari Foods, Inc.","Warren","MI","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Ohio, Michigan, West Virginia, Kentucky, Tennessee, Pennsylvania, Wisconsin, Illinois, and Indiana.","F-1659-2013","Class I","Item Number: 101643 Item Description: TUB CHOC DD PEANUTS Case Pack: 12 Package Size: 8 OZ 2-Piece Clear Tub (Zoppity Label on Top, Nutritional Label on Bottom) UPC Number: 094776095575 ","Lot Number: 22201304 Best By Date: 4/22/2014 ",".","33 cases","Contamination with Listeria monocytogenes, an organism which can cause serious and sometimes fatal infections in young children, frail or elderly people, and others with weakened immune systems. Although healthy individuals may suffer only short-term symptoms such as high fever, severe headache, stiffness, nausea, abdominal pain and diarrhea, Listeria infection can cause miscarriages and stillbirths among pregnant women.",6/4/2013,"06/04/2013",7/17/2013,"07/17/2013"
"Food",65392,"Ongoing","Lipari Foods, Inc.","Warren","MI","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Ohio, Michigan, West Virginia, Kentucky, Tennessee, Pennsylvania, Wisconsin, Illinois, and Indiana.","F-1679-2013","Class I","Item Number: 196274 Item Description: BAGS LG ALMOND SLICED Case Pack: 12 Package Size: 3.25 OZ Fully Preprinted New Style Pic-A-Nut Bag UPC Number: 070207018207 ","Lot Numbers: 08201304, 23201305 Best By Dates: 4/8/2014, 5/23/2014 ",".","89 cases","Contamination with Listeria monocytogenes, an organism which can cause serious and sometimes fatal infections in young children, frail or elderly people, and others with weakened immune systems. Although healthy individuals may suffer only short-term symptoms such as high fever, severe headache, stiffness, nausea, abdominal pain and diarrhea, Listeria infection can cause miscarriages and stillbirths among pregnant women.",6/4/2013,"06/04/2013",7/17/2013,"07/17/2013"
"Food",65392,"Ongoing","Lipari Foods, Inc.","Warren","MI","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Ohio, Michigan, West Virginia, Kentucky, Tennessee, Pennsylvania, Wisconsin, Illinois, and Indiana.","F-1689-2013","Class I","Item Number: 364761 Item Description: BAGS SUNFLOWER KERNEL RAW PP Case Pack: 12 Package Size: 12 OZ Clear Plastic Bag (Black Label on Front, Nutritional Label on Back) UPC Number: 094776110452 ","Lot Numbers: 08201304, 30201304, 05201306 Best By Dates: 4/8/2014, 4/30/2014, 6/5/2014 ",".","50 cases","Contamination with Listeria monocytogenes, an organism which can cause serious and sometimes fatal infections in young children, frail or elderly people, and others with weakened immune systems. Although healthy individuals may suffer only short-term symptoms such as high fever, severe headache, stiffness, nausea, abdominal pain and diarrhea, Listeria infection can cause miscarriages and stillbirths among pregnant women.",6/4/2013,"06/04/2013",7/17/2013,"07/17/2013"
"Food",65392,"Ongoing","Lipari Foods, Inc.","Warren","MI","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Ohio, Michigan, West Virginia, Kentucky, Tennessee, Pennsylvania, Wisconsin, Illinois, and Indiana.","F-1672-2013","Class I","Item Number: 193282 Item Description: BAG CLR CASHEW JUMBO N/SALT PP Case Pack: 12 Package Size: 9 OZ Clear Plastic Bag (Pic-A-Nut Label on Front, Nutritional Label on Back) UPC Number: 070207000288 ","Lot Number: 06201306 Best By Date: 6/6/2014 ",".","54 cases","Contamination with Listeria monocytogenes, an organism which can cause serious and sometimes fatal infections in young children, frail or elderly people, and others with weakened immune systems. Although healthy individuals may suffer only short-term symptoms such as high fever, severe headache, stiffness, nausea, abdominal pain and diarrhea, Listeria infection can cause miscarriages and stillbirths among pregnant women.",6/4/2013,"06/04/2013",7/17/2013,"07/17/2013"
"Food",65392,"Ongoing","Lipari Foods, Inc.","Warren","MI","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Ohio, Michigan, West Virginia, Kentucky, Tennessee, Pennsylvania, Wisconsin, Illinois, and Indiana.","F-1665-2013","Class I","Item Number: 192993 Item Description: BAG CLR SESAME STX OAT BRAN PP Case Pack: 12 Package Size: 4.75 OZ Clear Plastic Bag (Pic-A-Nut Label on Front, Nutritional Label on Back) UPC Number: 070207000011 ","Lot Number: 23201305 Best By Date: 5/23/2014 ",".","78 cases","Contamination with Listeria monocytogenes, an organism which can cause serious and sometimes fatal infections in young children, frail or elderly people, and others with weakened immune systems. Although healthy individuals may suffer only short-term symptoms such as high fever, severe headache, stiffness, nausea, abdominal pain and diarrhea, Listeria infection can cause miscarriages and stillbirths among pregnant women.",6/4/2013,"06/04/2013",7/17/2013,"07/17/2013"
"Food",65392,"Ongoing","Lipari Foods, Inc.","Warren","MI","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Ohio, Michigan, West Virginia, Kentucky, Tennessee, Pennsylvania, Wisconsin, Illinois, and Indiana.","F-1692-2013","Class I","Item Number: 364932 Item Description: BAGS PRETZELS YOGURT PP Case Pack: 12 Package Size: 10 OZ Clear Plastic Bag (Black Label on Front, Nutritional Label on Back) UPC Number: 094776110599 ","Lot Number: 08201304 Best By Date: 4/8/2014 ",".","122 cases","Contamination with Listeria monocytogenes, an organism which can cause serious and sometimes fatal infections in young children, frail or elderly people, and others with weakened immune systems. Although healthy individuals may suffer only short-term symptoms such as high fever, severe headache, stiffness, nausea, abdominal pain and diarrhea, Listeria infection can cause miscarriages and stillbirths among pregnant women.",6/4/2013,"06/04/2013",7/17/2013,"07/17/2013"
"Food",65392,"Ongoing","Lipari Foods, Inc.","Warren","MI","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Ohio, Michigan, West Virginia, Kentucky, Tennessee, Pennsylvania, Wisconsin, Illinois, and Indiana.","F-1685-2013","Class I","Item Number: 208903 Item Description: TUB SM PEPITA ROASTED W/SALT Case Pack: 12 Package Size: 8 OZ 2-Piece Clear Plastic Tub (No Label on Top, Nutritional Label on Bottom) UPC Number: 760208113017 ","Lot Number: 09201305 Best By Date: 5/9/2014 ",".","32 cases","Contamination with Listeria monocytogenes, an organism which can cause serious and sometimes fatal infections in young children, frail or elderly people, and others with weakened immune systems. Although healthy individuals may suffer only short-term symptoms such as high fever, severe headache, stiffness, nausea, abdominal pain and diarrhea, Listeria infection can cause miscarriages and stillbirths among pregnant women.",6/4/2013,"06/04/2013",7/17/2013,"07/17/2013"
"Food",65392,"Ongoing","Lipari Foods, Inc.","Warren","MI","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Ohio, Michigan, West Virginia, Kentucky, Tennessee, Pennsylvania, Wisconsin, Illinois, and Indiana.","F-1693-2013","Class I","Item Number: 365163 Item Description: BAGS BANANA CHIPS PP Case Pack: 12 Package Size: 10 OZ Clear Plastic Bag (Black Label on Front, Nutritional Label on Back) UPC Number: 094776110186 ","Lot Numbers: 08201304, 30201304 Best By Dates: 4/8/2014, 4/30/2014 ",".","177 cases","Contamination with Listeria monocytogenes, an organism which can cause serious and sometimes fatal infections in young children, frail or elderly people, and others with weakened immune systems. Although healthy individuals may suffer only short-term symptoms such as high fever, severe headache, stiffness, nausea, abdominal pain and diarrhea, Listeria infection can cause miscarriages and stillbirths among pregnant women.",6/4/2013,"06/04/2013",7/17/2013,"07/17/2013"
"Food",65392,"Ongoing","Lipari Foods, Inc.","Warren","MI","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Ohio, Michigan, West Virginia, Kentucky, Tennessee, Pennsylvania, Wisconsin, Illinois, and Indiana.","F-1676-2013","Class I","Item Number: 193775 Item Description: BAGS SM ALMOND SLIVERED Case Pack: 12 Package Size: 1.75 OZ Fully Preprinted Old Style Pic-A-Nut Bag UPC Number: 070207018412 ","Lot Numbers: 08201304, 23201305 Best By Dates: 4/8/2014, 5/23/2014 ",".","104 cases","Contamination with Listeria monocytogenes, an organism which can cause serious and sometimes fatal infections in young children, frail or elderly people, and others with weakened immune systems. Although healthy individuals may suffer only short-term symptoms such as high fever, severe headache, stiffness, nausea, abdominal pain and diarrhea, Listeria infection can cause miscarriages and stillbirths among pregnant women.",6/4/2013,"06/04/2013",7/17/2013,"07/17/2013"
"Food",65392,"Ongoing","Lipari Foods, Inc.","Warren","MI","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Ohio, Michigan, West Virginia, Kentucky, Tennessee, Pennsylvania, Wisconsin, Illinois, and Indiana.","F-1706-2013","Class I","Item Number: 423622 Item Description: TUB MD MIX CHERRY BERRY Case Pack: 12 Package Size: 12 OZ 2-Piece Clear Plastic Tub ('Cherry' Label on Top, Nutritional Label on Bottom) UPC Number: 094776111404 ","Lot Number: 16201305 Best By Date: 5/16/2014 ",".","0","Contamination with Listeria monocytogenes, an organism which can cause serious and sometimes fatal infections in young children, frail or elderly people, and others with weakened immune systems. Although healthy individuals may suffer only short-term symptoms such as high fever, severe headache, stiffness, nausea, abdominal pain and diarrhea, Listeria infection can cause miscarriages and stillbirths among pregnant women.",6/4/2013,"06/04/2013",7/17/2013,"07/17/2013"
"Food",65392,"Ongoing","Lipari Foods, Inc.","Warren","MI","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Ohio, Michigan, West Virginia, Kentucky, Tennessee, Pennsylvania, Wisconsin, Illinois, and Indiana.","F-1666-2013","Class I","Item Number: 193010 Item Description: BAGS SM CASHEW JUMBO R/S Case Pack: 12 Package Size: 1 OZ Fully Preprinted Old Style Pic-A-Nut Bag UPC Number: 070207022068 ","Lot Number: 23201305 Best By Date: 5/23/2014 ",".","94 cases","Contamination with Listeria monocytogenes, an organism which can cause serious and sometimes fatal infections in young children, frail or elderly people, and others with weakened immune systems. Although healthy individuals may suffer only short-term symptoms such as high fever, severe headache, stiffness, nausea, abdominal pain and diarrhea, Listeria infection can cause miscarriages and stillbirths among pregnant women.",6/4/2013,"06/04/2013",7/17/2013,"07/17/2013"
"Food",65392,"Ongoing","Lipari Foods, Inc.","Warren","MI","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Ohio, Michigan, West Virginia, Kentucky, Tennessee, Pennsylvania, Wisconsin, Illinois, and Indiana.","F-1688-2013","Class I","Item Number: 357642 Item Description: TUB SM ALMOND WHOLE RAW Case Pack: 12 Package Size: 10 OZ 2-Piece Clear Plastic Tub (No Label on Top, Nutritional Label on Bottom) UPC Number: 760208107450 ","Lot Numbers: 23201305, 24201305 Best By Dates: 05/23/2014, 05/24/2014 ",".","186 cases","Contamination with Listeria monocytogenes, an organism which can cause serious and sometimes fatal infections in young children, frail or elderly people, and others with weakened immune systems. Although healthy individuals may suffer only short-term symptoms such as high fever, severe headache, stiffness, nausea, abdominal pain and diarrhea, Listeria infection can cause miscarriages and stillbirths among pregnant women.",6/4/2013,"06/04/2013",7/17/2013,"07/17/2013"
"Food",65392,"Ongoing","Lipari Foods, Inc.","Warren","MI","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Ohio, Michigan, West Virginia, Kentucky, Tennessee, Pennsylvania, Wisconsin, Illinois, and Indiana.","F-1704-2013","Class I","Item Number: 395203 Item Description: TUB LG SUNFLOWER MEAT RAW Case Pack: 12 Package Size: 14 OZ 2-Piece Clear Plastic Tub (No label on Top, Nutritional Label on Bottom) UPC Number: 094776081738 ","Lot Numbers: 09201304, 24201304, 01201305, 20201305, 30201305 Best By Dates: 4/9/2014, 4/24/2014, 5/1/2014, 5/20/2014, 5/30/2014 ",".","121 cases","Contamination with Listeria monocytogenes, an organism which can cause serious and sometimes fatal infections in young children, frail or elderly people, and others with weakened immune systems. Although healthy individuals may suffer only short-term symptoms such as high fever, severe headache, stiffness, nausea, abdominal pain and diarrhea, Listeria infection can cause miscarriages and stillbirths among pregnant women.",6/4/2013,"06/04/2013",7/17/2013,"07/17/2013"
"Food",65392,"Ongoing","Lipari Foods, Inc.","Warren","MI","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Ohio, Michigan, West Virginia, Kentucky, Tennessee, Pennsylvania, Wisconsin, Illinois, and Indiana.","F-1707-2013","Class I","Item Number: 545303 Item Description: NATURAL GINGER CRYSTALLIZED Case Pack: 12 Package Size: 7 OZ 2-Piece Clear Plastic Tub (Alex's Natural Label on Top, Nutritional Label on Bottom) UPC Number: 094776082940 ","Lot Number: 09201305 Best By Date: 5/9/2014 ",".","90 cases","Contamination with Listeria monocytogenes, an organism which can cause serious and sometimes fatal infections in young children, frail or elderly people, and others with weakened immune systems. Although healthy individuals may suffer only short-term symptoms such as high fever, severe headache, stiffness, nausea, abdominal pain and diarrhea, Listeria infection can cause miscarriages and stillbirths among pregnant women.",6/4/2013,"06/04/2013",7/17/2013,"07/17/2013"
"Food",65392,"Ongoing","Lipari Foods, Inc.","Warren","MI","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Ohio, Michigan, West Virginia, Kentucky, Tennessee, Pennsylvania, Wisconsin, Illinois, and Indiana.","F-1709-2013","Class I","Item Number: 545803 Item Description: NATURAL SUNFLOWER KERNEL Case Pack: 12 Package Size: 9 OZ 2-Piece Clear Plastic Tub (Alex's Natural Label on Top, Nutritional Label on Bottom) UPC Number: 094776082995 ","Lot Numbers: 08201304, 22201304, 08201305, 09201305, 23201305, 24201305 Best By Dates: 4/8/2014, 4/22/2014, 5/8/2014, 5/9/2014, 5/23/2014, 5/24/2014 ",".","139 cases ","Contamination with Listeria monocytogenes, an organism which can cause serious and sometimes fatal infections in young children, frail or elderly people, and others with weakened immune systems. Although healthy individuals may suffer only short-term symptoms such as high fever, severe headache, stiffness, nausea, abdominal pain and diarrhea, Listeria infection can cause miscarriages and stillbirths among pregnant women.",6/4/2013,"06/04/2013",7/17/2013,"07/17/2013"
"Food",65392,"Ongoing","Lipari Foods, Inc.","Warren","MI","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Ohio, Michigan, West Virginia, Kentucky, Tennessee, Pennsylvania, Wisconsin, Illinois, and Indiana.","F-1697-2013","Class I","Item Number: 368729 Item Description: TUB MD HAZELNUT/FILBERT RAW Case Pack: 12 Package Size: 9 OZ 2-Piece Clear Plastic Tub (No Label on Top, Nutritional Label on Bottom) UPC Number: 094776110049 ","Lot Number: 30201305 Best By Date: 05/30/2014 ",".","86 cases","Contamination with Listeria monocytogenes, an organism which can cause serious and sometimes fatal infections in young children, frail or elderly people, and others with weakened immune systems. Although healthy individuals may suffer only short-term symptoms such as high fever, severe headache, stiffness, nausea, abdominal pain and diarrhea, Listeria infection can cause miscarriages and stillbirths among pregnant women.",6/4/2013,"06/04/2013",7/17/2013,"07/17/2013"
"Food",65392,"Ongoing","Lipari Foods, Inc.","Warren","MI","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Ohio, Michigan, West Virginia, Kentucky, Tennessee, Pennsylvania, Wisconsin, Illinois, and Indiana.","F-1702-2013","Class I","Item Number: 379235 Item Description: BAG CLEAR PINE NUTS Case Pack: 12 Package Size: 3 OZ Clear Plastic Bag (Pic-A-Nut Label on Front, Nutritional Label on Back) UPC Number: 094776110087 ","Lot Number: 03201306 Best By Date: 6/3/2014 ",".","23 cases","Contamination with Listeria monocytogenes, an organism which can cause serious and sometimes fatal infections in young children, frail or elderly people, and others with weakened immune systems. Although healthy individuals may suffer only short-term symptoms such as high fever, severe headache, stiffness, nausea, abdominal pain and diarrhea, Listeria infection can cause miscarriages and stillbirths among pregnant women.",6/4/2013,"06/04/2013",7/17/2013,"07/17/2013"
"Food",65392,"Ongoing","Lipari Foods, Inc.","Warren","MI","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Ohio, Michigan, West Virginia, Kentucky, Tennessee, Pennsylvania, Wisconsin, Illinois, and Indiana.","F-1690-2013","Class I","Item Number: 364773 Item Description: BAGS PUMPKIN SEEDS NATURAL PP Case Pack: 12 Package Size: 9 OZ Clear Plastic Bag (Black Label on Front, Nutritional Label on Back) UPC Number: 094776110353 ","Lot Number: 05201306 Best By Date: 6/5/2014 ",".","49 cases","Contamination with Listeria monocytogenes, an organism which can cause serious and sometimes fatal infections in young children, frail or elderly people, and others with weakened immune systems. Although healthy individuals may suffer only short-term symptoms such as high fever, severe headache, stiffness, nausea, abdominal pain and diarrhea, Listeria infection can cause miscarriages and stillbirths among pregnant women.",6/4/2013,"06/04/2013",7/17/2013,"07/17/2013"
"Food",65392,"Ongoing","Lipari Foods, Inc.","Warren","MI","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Ohio, Michigan, West Virginia, Kentucky, Tennessee, Pennsylvania, Wisconsin, Illinois, and Indiana.","F-1698-2013","Class I","Item Number: 368768 Item Description: TUB LG SUNFLOWER MEAT R/NS Case Pack: 12 Package Size: 14 OZ 2-Piece Clear Plastic Tub (No Label on Top, Nutritional Label on Bottom) UPC Number: 094776081752 ","Lot Numbers: 09201304, 24201304, 20201305, 30201305 Best By Dates: 4/9/2014, 04/24/2014, 05/20/2014, 05/30/2014 ",".","462 cases","Contamination with Listeria monocytogenes, an organism which can cause serious and sometimes fatal infections in young children, frail or elderly people, and others with weakened immune systems. Although healthy individuals may suffer only short-term symptoms such as high fever, severe headache, stiffness, nausea, abdominal pain and diarrhea, Listeria infection can cause miscarriages and stillbirths among pregnant women.",6/4/2013,"06/04/2013",7/17/2013,"07/17/2013"
"Food",65392,"Ongoing","Lipari Foods, Inc.","Warren","MI","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Ohio, Michigan, West Virginia, Kentucky, Tennessee, Pennsylvania, Wisconsin, Illinois, and Indiana.","F-1671-2013","Class I","Item Number: 193129 Item Description: BAGS LG CASHEW JUMBO R/S Case Pack: 12 Package Size: 6 OZ Fully Preprinted New Style Pic-A-Nut Bag UPC Number: 070207022853 ","Lot Numbers: 15201304, 23201305 Best By Dates: 4/15/2014, 5/23/2014 ",".","255 cases","Contamination with Listeria monocytogenes, an organism which can cause serious and sometimes fatal infections in young children, frail or elderly people, and others with weakened immune systems. Although healthy individuals may suffer only short-term symptoms such as high fever, severe headache, stiffness, nausea, abdominal pain and diarrhea, Listeria infection can cause miscarriages and stillbirths among pregnant women.",6/4/2013,"06/04/2013",7/17/2013,"07/17/2013"
"Food",65392,"Ongoing","Lipari Foods, Inc.","Warren","MI","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Ohio, Michigan, West Virginia, Kentucky, Tennessee, Pennsylvania, Wisconsin, Illinois, and Indiana.","F-1678-2013","Class I","Item Number: 193894 Item Description: BAGS SM ALMONDS WHOLE RAW Case Pack: 12 Package Size: 1.75 OZ Fully Preprinted New Style Pic-A-Nut Bag UPC Number: 070207018405 ","Lot Number: 06201306 Best By Date: 6/6/2014 ",".","114 cases","Contamination with Listeria monocytogenes, an organism which can cause serious and sometimes fatal infections in young children, frail or elderly people, and others with weakened immune systems. Although healthy individuals may suffer only short-term symptoms such as high fever, severe headache, stiffness, nausea, abdominal pain and diarrhea, Listeria infection can cause miscarriages and stillbirths among pregnant women.",6/4/2013,"06/04/2013",7/17/2013,"07/17/2013"
"Food",65392,"Ongoing","Lipari Foods, Inc.","Warren","MI","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Ohio, Michigan, West Virginia, Kentucky, Tennessee, Pennsylvania, Wisconsin, Illinois, and Indiana.","F-1663-2013","Class I","Item Number: 192959 Item Description: BAGS SM PEPITA SEEDS R/S Case Pack: 12 Package Size: 2.75 OZ Clear Plastic Bag (Pic-A-Nut Label on Front, Nutritional Label on Back) UPC Number: 070207022501 ","Lot Number: 23201305 Best By Date: 5/23/2014 ",".","115 cases","Contamination with Listeria monocytogenes, an organism which can cause serious and sometimes fatal infections in young children, frail or elderly people, and others with weakened immune systems. Although healthy individuals may suffer only short-term symptoms such as high fever, severe headache, stiffness, nausea, abdominal pain and diarrhea, Listeria infection can cause miscarriages and stillbirths among pregnant women.",6/4/2013,"06/04/2013",7/17/2013,"07/17/2013"
"Food",65392,"Ongoing","Lipari Foods, Inc.","Warren","MI","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Ohio, Michigan, West Virginia, Kentucky, Tennessee, Pennsylvania, Wisconsin, Illinois, and Indiana.","F-1686-2013","Class I","Item Number: 224411 Item Description: MIX CHERRY BERRY DELITE Case Pack: 1 Package Size: 25# Cardboard Box with Plastic Liner UPC: 094776121793 ","Lot Number: 15201304 Best By Date: 04/15/14 ",".","53 units","Contamination with Listeria monocytogenes, an organism which can cause serious and sometimes fatal infections in young children, frail or elderly people, and others with weakened immune systems. Although healthy individuals may suffer only short-term symptoms such as high fever, severe headache, stiffness, nausea, abdominal pain and diarrhea, Listeria infection can cause miscarriages and stillbirths among pregnant women.",6/4/2013,"06/04/2013",7/17/2013,"07/17/2013"
"Food",65392,"Ongoing","Lipari Foods, Inc.","Warren","MI","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Ohio, Michigan, West Virginia, Kentucky, Tennessee, Pennsylvania, Wisconsin, Illinois, and Indiana.","F-1668-2013","Class I","Item Number: 193061 Item Description: BAG CLR ALMOND SLICED RAW PP Case Pack: 12 Package Size: 9 OZ Clear Plastic Bag (Pic-A-Nut Label on Front, Nutritional Label on Back) UPC Number: 070207000110 ","Lot Numbers: 08201304, 23201305, 03201306 Best By Dates: 4/8/2014, 5/23/2014, 6/3/2014 ",".","85 cases","Contamination with Listeria monocytogenes, an organism which can cause serious and sometimes fatal infections in young children, frail or elderly people, and others with weakened immune systems. Although healthy individuals may suffer only short-term symptoms such as high fever, severe headache, stiffness, nausea, abdominal pain and diarrhea, Listeria infection can cause miscarriages and stillbirths among pregnant women.",6/4/2013,"06/04/2013",7/17/2013,"07/17/2013"
"Food",65392,"Ongoing","Lipari Foods, Inc.","Warren","MI","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Ohio, Michigan, West Virginia, Kentucky, Tennessee, Pennsylvania, Wisconsin, Illinois, and Indiana.","F-1708-2013","Class I","Item Number: 545603 Item Description: NATURAL ALMONDS DARK CHOC Case Pack: 12 Package Size: 11 OZ 2-Piece Clear Plastic Tub (Alex's Natural Label on Top, Nutritional Label on Bottom) UPC Number: 094776082971 ","Lot Number: 08201304 Best By Date: 4/8/2014 ",".","207 cases","Contamination with Listeria monocytogenes, an organism which can cause serious and sometimes fatal infections in young children, frail or elderly people, and others with weakened immune systems. Although healthy individuals may suffer only short-term symptoms such as high fever, severe headache, stiffness, nausea, abdominal pain and diarrhea, Listeria infection can cause miscarriages and stillbirths among pregnant women.",6/4/2013,"06/04/2013",7/17/2013,"07/17/2013"
"Food",65392,"Ongoing","Lipari Foods, Inc.","Warren","MI","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Ohio, Michigan, West Virginia, Kentucky, Tennessee, Pennsylvania, Wisconsin, Illinois, and Indiana.","F-1710-2013","Class I","Item Number: 631215 Item Description: SUNFLOWER SEED KERNELS RAW Case Pack: 1 Package Size: 50# Brown Bag UPC Number: 079348999086 ","50# Lot Numbers: PRO-1346, PRO-1349 Best By Date: April 2014 ",".","1295 (50# bag) ","Contamination with Listeria monocytogenes, an organism which can cause serious and sometimes fatal infections in young children, frail or elderly people, and others with weakened immune systems. Although healthy individuals may suffer only short-term symptoms such as high fever, severe headache, stiffness, nausea, abdominal pain and diarrhea, Listeria infection can cause miscarriages and stillbirths among pregnant women.",6/4/2013,"06/04/2013",7/17/2013,"07/17/2013"
"Food",65392,"Ongoing","Lipari Foods, Inc.","Warren","MI","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Ohio, Michigan, West Virginia, Kentucky, Tennessee, Pennsylvania, Wisconsin, Illinois, and Indiana.","F-1695-2013","Class I","Item Number: 366568 Item Description: TUB LG MIX DIET DELIGHT Case Pack: 12 Package Size: 14 OZ 2-Piece Clear Plastic Tub (No Label on Top, Nutritional Label on Bottom) UPC Number: 094776081769 ","Lot Numbers: 09201304, 20201305 Best By Dates: 4/9/2014, 05/20/2014 ",".","203 cases ","Contamination with Listeria monocytogenes, an organism which can cause serious and sometimes fatal infections in young children, frail or elderly people, and others with weakened immune systems. Although healthy individuals may suffer only short-term symptoms such as high fever, severe headache, stiffness, nausea, abdominal pain and diarrhea, Listeria infection can cause miscarriages and stillbirths among pregnant women.",6/4/2013,"06/04/2013",7/17/2013,"07/17/2013"
"Drugs",65393,"Ongoing","Pfizer Inc.","New York","NY","US","Voluntary: Firm Initiated","Letter","Nationwide and Puerto Rico","D-631-2013","Class III","Prempro (Conjugated Estrogen/Medroxyprogesterone Acetate) tablets 0.625 mg/5.0 mg, 1 blister card containing 28 tablets, Rx only, Wyeth Pharmaceuticals Inc., Philadelphia, PA 1910, NDC 0046-0875-11 ","Lots: E77055, E96153, & F11111 Exp: 06/13",".","135,520 blister cards","Failed Dissolution Specifications: Pfizer Inc. (Pfizer) is recalling PREMPRO (conjugated estrogens/medroxyprogesterone acetate tablets) because certain lots for this product may not meet the specification for conjugated estrogens dissolution.",5/31/2013,"05/31/2013",7/10/2013,"07/10/2013"
"Drugs",65393,"Ongoing","Pfizer Inc.","New York","NY","US","Voluntary: Firm Initiated","Letter","Nationwide and Puerto Rico","D-630-2013","Class III","Prempro (Conjugated Estrogen/Medroxyprogesterone Acetate) tablets 0.625 mg/2.5 mg, 1 blister card containing 28 tablets, Rx only, Wyeth Pharmaceuticals Inc., Philadelphia, PA","Lots: E67324 & E96152 Exp: 06/13",".","432,657 blister cards","Failed Dissolution Specifications: Pfizer Inc. is recalling PREMPRO (conjugated estrogens/medroxyprogesterone acetate tablets) because certain lots for this product may not meet the dissolution specification for conjugated estrogens.",5/31/2013,"05/31/2013",7/10/2013,"07/10/2013"
"Drugs",65394,"Ongoing","Zydus Pharmaceuticals USA Inc","Pennington","NJ","US","Voluntary: Firm Initiated","Letter","Nationwide","D-838-2013","Class I","Warfarin Sodium Tablets, USP 2 mg, Rx Only, 1000 Tablets per bottle, Manufactured by: Cadila Healthcare Ltd Ahmedabad, India, Distributed by: Zydus Pharmaceuticals USA Inc., Pennington, NJ 08534, NDC 68382-053-10 ","Lot MM5767",".","960 Bottles","Failed Tablet/Capsule Specifications: A product complaint was received from a pharmacist who discovered that 3 tablets in a 1000-count bottle were oversized.",5/13/2013,"05/13/2013",8/14/2013,"08/14/2013"
"Devices",65395,"Ongoing","Bard Peripheral Vascular Inc","Tempe","AZ","US","Voluntary: Firm Initiated","Letter","US Nationwide Distribution","Z-1533-2013","Class II","BARD PERIPHERAL VASCULAR VACCESS PTA Balloon Dilatation Catheters, 8mm x 4cm x 80cm. Product Usage: Vaccess PTA Balloon Dilatation Catheters are recommended for use in Percutaneous Transluminal Angioplasty of the femoral, iliac and renal arteries and for the treatment of obstructive lesions of native or synthetic arteriovenous dialysis fistulae. This device is also recommended for post-dilatation of balloon expandable stents, self-expanding stents and stent grafts in the peripheral vasculature. This catheter is not for use in coronary arteries. Vaccess PTA Balloon Dilatation Catheters are supplied sterile and intended for single use.","Product Codes and Lot Numbers, respectively: VA8084R, 93JW0056 VA8084, 937W0090",".","415 ","Bard Peripheral Vascular (BPV) has confirmed that some product code/lot number combination of devices may have the incorrect balloon diameter labeled on the inflation hub. Specifically, the balloon size printed on the hub may read 7mm x 4cm, when the actual balloon size is 8mm x 4cm. All other product labeling is consistent with the actual 8mm x 4cm balloon size.",5/28/2013,"05/28/2013",6/19/2013,"06/19/2013"
"Food",65396,"Ongoing","Allergy Research Group","Alameda","CA","US","Voluntary: Firm Initiated","Letter","Distributors, Wholesalers, healthcare providers and retail customers in the USA. Nutrilink in England and DeltaStar in the Netherlands are distributors in Europe.","F-1636-2013","Class II","Wholly Immune Powder, Total Immune Nutrient Support; 300 gram (10.6 oz) and 900 gram ( 31.7 oz.) containers. Also packaged as Complete Immune Powder and packed in 300 and 900 gram containers. Suggested use: As a dietary supplement, 1 level scoop one or two times daily, mixed with desired liquid or as directed by a healthcare practitioner. California Proposition 65 warning: this product contains lead, a chemical known to the State of California to cause birth defects or other reproductive harm. UCP 13947-73560 and 13947 73820 formulated exclusively for Allergy Research Group, Alameda, CA 94502.","Product number 73560, 53560 - 300 gr. Lot numbers: 11030685, Exp 6/1/13; 11030686, Exp 6/1/13; 11100829, Exp 11/1/13; 11100835, Exp 11/1/13; 12010362, Exp 4/1/14; 12061214, Exp 8/1/14; 12061217, Exp 8/1/14; 13010635, Exp. 2/1/15. Product number 73820, 53820 - 900 gr. Lot numbers: 11030676, Exp Jun 2013; 11030686, Exp 6/1/13; 11100836, Exp 11/1/13; 12010363, Exp 4/25/14; 12061215, Exp 8/1/14; 12061218, Exp 8/1/14; 13010636, Exp 2/1/15; ",".","3000 units of 300 gr powder bottles' 1869 units of 900 gr bottles","Allergy Research Group received word from their contract manufacturer, ABCO Laboratories, that two of their products have been manufactured with soy based products from CHS Inc. at it Ashdod, Israel facility.",5/29/2013,"05/29/2013",7/17/2013,"07/17/2013"
"Devices",65397,"Ongoing","Terumo Medical Corporation","Elkton","MD","US","Voluntary: Firm Initiated","Letter","Nationwide Distribution.","Z-1611-2013","Class II","Pinnacle Destination Peripheral Guiding Sheath, 8 French, 90cm, Straight Tip, Cross Cut Valve. Acts as a conduit to facilitate the introduction of interventional and diagnostic devices into the human vasculature.","Lot MM27",,"20 units","Medical devices were incorrectly labeled with extended expiration dates.",5/30/2013,"05/30/2013",7/3/2013,"07/03/2013"
"Devices",65397,"Ongoing","Terumo Medical Corporation","Elkton","MD","US","Voluntary: Firm Initiated","Letter","Nationwide Distribution.","Z-1612-2013","Class II","Terumo Glidesheath (tm), 6 French, Nitinol wire, product code 15-1060. Used to facilitate placing a catheter through the skin into a vein or artery.","Lot MP08",,"550 units","Medical devices were incorrectly labeled with extended expiration dates.",5/30/2013,"05/30/2013",7/3/2013,"07/03/2013"
"Food",65398,"Ongoing","Oskri Corp.","Lake Mills","WI","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","MA","F-1540-2013","Class II","Box: Oskri, Sesame Bars Date Syrup, Gluten Free, Halal Vegetarian, 5 Bars each 1.9 oz (53g) total weight 9.5 oz (265g), UPC 6 66016 40052 6. Individual bar: Oskri Sesame Bar With Date Syrup,Gluten Free, Net WT 1.9 oz (53g)","P3/3/13 EXP 9/9/14 Lot 84",,"42 cases (40 boxes per case) (5 bars per box)","Oskri Corp. of Lake Mills, WI is recalling 1650 (5 pack) of ''Sesame Bars Date Syrup'' because they may contain copper shavings.",5/31/2013,"05/31/2013",6/26/2013,"06/26/2013"
"Devices",65399,"Ongoing","Instrumentation Laboratory Co.","Bedford","MA","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution- US (nationwide) including states of: MA, ME, CT, NJ, NY, PA, MD, VA, NC, SC, GA, FL, AL, TN, MS, KY, OH, IN, MI, IA, WI, MN, SD, MT, IL, MO, KS, NE, LA, AR, OK, TX, CO, ID, AZ, CA, OR, WA, AK, RI, VT and the countries of: Angola, Argentina, Australia, Austria, Belgium, Bermuda, Brazil, Bulgaria, Canada, Caribbean, Chile, Colombia, Costa Rica, Czech, Denmark, Dubai, Ecuador, Egypt, France, Germany, Gibraltar, Great Britain, Greece, Guatemala, Hungary, India, Indonesia, Iran, Israel, Italy, Jamaica, Jordan, Korea, Kossovo, Kuwait, Lebanon, Lithuania, Malaysia, Malta, Mexico, Morocco, Netherlands, Norway, Panama, Peru, Philippines, Poland, Portugal, Romania, Russia, Saudi Arabia, Serbia, Singapore, Slovenia, South Africa, Spain, Sweden, Switzerland, Syria, Taiwan, Thailand, Trinidad, Turkey, Ukraine, Uruguay, Vietnam, and Japan.","Z-1784-2013","Class II","HemosIL RecombiPlasTin 2G, Part Number 0020002950 (8 ml size). The product is used for the evaluation of the extrinsic coagulation pathway and the monitoring of Oral Anticoagulant Therapy.","Part Number applies to all: 0020002950 - all product lots. Lot Numbers: 1) N0716706 Exp. Date 5/31/2013, 2) N0817321 Exp. Date 5/31/2013, 3) E0917396 Exp. Date 9/30/2013, 4)) N0917378 Exp. Date 9/30/2013, 5) N1118029 Exp. Date 10/31/2013, 6) N0128669 Exp. Date 1/31/2014, 7) N0329291 Exp. Date 2/28/2014, 8) N0429596 Exp. Date 3/31/2014, 9) N0520056 Exp. Date 5/31/2014,10) E0720822 Exp. Date 7/31/2014, 11) N0821174 Exp. Date 8/31/2014, 12) N091388 Exp. Date 9/30/2014, 13) N0921522 Exp. Date 9/30/2014, 14) N0132676 Exp. Date 1/31/2015 and 15) N1222567 Exp. Date 1/31/2015.",,"Kits per product:1)11080, 2)11603, 3)11487, 4)11483, 5)11290, 6)11562, 7)11535, 8)11577, 9)11505, 10)11708,11)11579,12)11580, 13&14) not distributed","Instrumentation Laboratory is recalling HemosIL RecombiPlasTin 2G (RPT2G), Part No. 0020009580 (8 mL Size) due to being Out of Specification. ",4/9/2013,"04/09/2013",7/31/2013,"07/31/2013"
"Drugs",65400,"Ongoing","Hospira Inc.","Lake Forest","IL","US","Voluntary: Firm Initiated","Letter","Nationwide and Puerto Rico","D-608-2013","Class II","0.9% Sodium Chloride Injection, USP, 250 mL single dose Flexible Plastic Container, Rx only, Hospira, Inc., Lake Forest, IL 60045 USA, NDC 0409-7983-02","Lot #: 16-031-JT*, Exp 1APR2014; Note the * may be followed by 01 or 02",,"676,872 containers","Lack of Assurance of Sterility: The product has the potential for solution to leak at or near the administrative port of the primary container.",6/6/2013,"06/06/2013",6/26/2013,"06/26/2013"
"Devices",65401,"Ongoing","Etac Supply Center Ab","Anderstorp",,"SE","Voluntary: Firm Initiated","Letter","International distribution: Austria, Australia, Belgium, Brazil, Canada, Czech Republic, Denmark, Esonia, Finland, France, Great Britain, Germany, Greece, Hong Kong, Ireland, Isreal, Iceland, Italy, Kingdom of Bahrain, Kuwait, Lithuania, Netherlands, Norge, New Zealand, Spain, Switzerland, Sweden, and United Arab Emirates.","Z-1807-2013","Class II","Swift Mobil shower chair, Swift Mobil 160 shower chair, and Swift Mobil Tilt shower chair. Height adjustable four wheeled shower chairs for persons of various weights. ","Affected Serial numbers: 3829 to 11028 (same series for all Swift Mobil products)",,"7200 internationally","Etac is voluntarily conducting a field correction of the Etac Swift Mobil shower chair. If the Swift Mobil shower chair loses a caster and thus becomes instantly unstable, there is potiential risk for harm or injury.",5/23/2013,"05/23/2013",7/31/2013,"07/31/2013"
"Biologics",65402,"Terminated","Mississippi Blood Services Inc.","Flowood","MS","US","Voluntary: Firm Initiated","FAX","Mississippi; Switzerland","B-2129-13","Class III","Blood and Blood Products for Reprocessing","W069112156683; ",,"1","Blood products, collected from a donor whose suitability to donate was not adequately determined, were distributed.",5/7/2013,"05/07/2013",9/4/2013,"09/04/2013"
"Biologics",65402,"Terminated","Mississippi Blood Services Inc.","Flowood","MS","US","Voluntary: Firm Initiated","FAX","Mississippi; Switzerland","B-2128-13","Class II","Red Blood Cells Leukocytes Reduced","W069112156683; ",,"1","Blood products, collected from a donor whose suitability to donate was not adequately determined, were distributed.",5/7/2013,"05/07/2013",9/4/2013,"09/04/2013"
"Biologics",65403,"Terminated","OneBlood, Inc.","Miami","FL","US","Voluntary: Firm Initiated","Telephone","Switzerland; Florida","B-2223-13","Class II","Red Blood Cells Leukocytes Reduced","W036813010029; ",".","1 unit","Blood products, collected from an ineligible donor, were distributed. ",5/15/2013,"05/15/2013",9/11/2013,"09/11/2013"
"Biologics",65403,"Terminated","OneBlood, Inc.","Miami","FL","US","Voluntary: Firm Initiated","Telephone","Switzerland; Florida","B-2225-13","Class III","Blood and Blood Products for Reprocessing","W036809266093; W036810226326; W036813010029; ",".","3 units","Blood products, collected from an ineligible donor, were distributed. ",5/15/2013,"05/15/2013",9/11/2013,"09/11/2013"
"Biologics",65403,"Terminated","OneBlood, Inc.","Miami","FL","US","Voluntary: Firm Initiated","Telephone","Switzerland; Florida","B-2224-13","Class II","Red Blood Cells","2438324; 2685776; W036809266093; W036810226326; ",".","4 units","Blood products, collected from an ineligible donor, were distributed. ",5/15/2013,"05/15/2013",9/11/2013,"09/11/2013"
"Biologics",65404,"Terminated","Wellmont Health System Dba Marsh Regional Blood Center","Kingsport","TN","US","Voluntary: Firm Initiated","FAX","Tennessee","B-2132-13","Class II","Red Blood Cells Leukocytes Reduced","W241213800142; ",,"1","Blood product, collected from a donor who reported travel to a malarial endemic area, was distributed.",4/22/2013,"04/22/2013",9/4/2013,"09/04/2013"
"Devices",65406,"Ongoing","Integra LifeSciences Corporation","Plainsboro","NJ","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution-USA (nationwide) and the countries of Austria, Australia, Belgium, Canada, Czech Republic, Denmark, Finland, France, Germany, Great Britain, Ireland, Israel, Italy, Netherlands, Portugal, Russia, Saudia Arabia, South Africa, Spain and United Arab Emirates.","Z-1736-2013","Class II"," Integra PANTA Arthrodesis Nail System. Intended for use in tibiotalocalcaneal arthrodesis and treatment of trauma to the hindfoot and distal tibia.","All lot numbers for PANTA Arthrodesis Nail Support Device Catalogue Nos: 519-110 and 519-130 from May 2006 to current.",".","692 ","As a result of the investigation into an adverse trend of complaints for reports of misalignment of the calcaneal or tibial screws during use of the Panta Nail Support Device, Integra has decided to issue this voluntary medical device correction. The misalignment can result in the inability to properly insert the screws into the Panta Nail and create the potential need for revision surgery. ",5/9/2013,"05/09/2013",7/24/2013,"07/24/2013"
"Devices",65407,"Terminated","ConBio, a CynoSure Company","Fremont","CA","US","Voluntary: Firm Initiated","Telephone","Worldwide distribution: USA (nationwide) including states of: IL, ME, NM and VA; and countries of: Australia and Chile.","Z-1599-2013","Class II","Multilite Dye Handpieces, an optional accessory of the RevLite SI Laser. The Revlite SI laser is intended for General Dermatology, Dermatologic and General Surgical Procedures. Which includes treatments such as tattoo removal, pigmented lesion removal, removal or lightening of hair, skin resurfacing and reduction of red pigmentation in hypertropic and keloid scars The two Multilite Dye Handpieces (HPs) are optional handpieces that can be used with the Revlite SI Laser. Manufactured by: ConBio, A Cynosure Company 47733 Fremont blvd Fremont, CA 94538 ","659-1050-585 nm Handpiece; Manufacturer numbers: 659-1050 / C13B1141 659-1050 / D13C1151 659-1050 / D13C1157 659-1050 / D13C1158 659-1050 / D13C1160 659-1050 / D13C1154 Model 659-1100 - 650 nm Handpiece; manufacturer numbers: 659-1100 / C13B1141 659-1100 / D13C1151 659-1100 / D13C1157 659-1100 / D13C1158 659-1100 / D13C1160 659-1100 / D13D1165.",,"12 (6 of model 659-1050; 6 of model 659-1100)","An inconsistency was identified related to electronic display identification of the optional Multilite Dye Handpieces of the RevLite SI Laser system that may confuse user.",5/9/2013,"05/09/2013",7/3/2013,"07/03/2013"
"Devices",65408,"Ongoing","Siemens Healthcare Diagnostics, Inc.","Newark","DE","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution: USA (nationwide) and iinternationally to Canada.","Z-0430-2014","Class II","Dimension Vista(R) 500 and Dimension Vista(R) 1500 - Reloaded Vista Vials - limited to systems using software versions 3.4 and 3.5.1. Diagnostic device intended to determine a variety of analytes in human body fluids. ","Dimension Vista(R) 500 - Siemens Material Number 10284473 and Dimension Vista(R) 1500 - Siemens Material Number 10444801",".","776","There is the potential for the vial volume of ''in use'' Vista calibrators, controls, or sample diluent to incorrectly revert to full volume when removed and reloaded. Dimension Vista(R) 500 and Dimension Vista(R) 1500 - Reloaded Vista Vials - limited to systems using software versions 3.4 and 3.5.1",5/20/2013,"05/20/2013",12/11/2013,"12/11/2013"
"Devices",65410,"Ongoing","BRAEMAR, INC.","Eagan","MN","US","Voluntary: Firm Initiated","Telephone","Nationwide Distribution including FL, IL, LMD, MA, MN, NY, OH, PA, TN, and TX.","Z-1652-2013","Class II","Lithium Thionyl non-rechargeable disposable battery pack P/N 350-0294-01 used with ER920 Wireless Series Arrhythmia Event Recorder. Non-rechargeable disposable battery pack.","n/a",".","3286 packs","Braemar has recently became aware of a battery related incident that occurred with EWT battery packs that are used in a Braemer ER920W wireless event monitor and Fusion device. The event did not result in any patient related injury or present any clinical impact. ",2/24/2012,"02/24/2012",7/10/2013,"07/10/2013"
"Devices",65411,"Ongoing","Medrad Inc","Indianola","PA","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution - US Nationwide including the states of AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, NC, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV, and WY and the countries of: AE, AU, AZ, BN, BR, CA, CH, CL, CO, DE, DK, DO, DZ, EG, ES, FR, GB, HK, HN, HR, HU, IN, IT, JO, JP, KR, LB, MU, MX, MY, NL, PH, PS, SA, SG, TH, TR, TW, UY, VE, and ZA.","Z-1586-2013","Class II","DC power cable (p/n 3010556) supplied with the MEDRAD(R) Veris MR Vital Signs Monitor: Product Usage: Monitor, Physiological, Patient ","Catalog numbers 3011992, 3011992W, 3011993, 3011993W, 3011994, 3011994W, 3011996, 3011996W, 3014268 and 3014268W.",,"1,066","The firm is recalling these power cables due to a latent design reliability issue and the potential for shorting which can result in heating/melting of the cable jacket.",4/15/2013,"04/15/2013",7/3/2013,"07/03/2013"
"Food",65412,"Ongoing","Sequel Naturals Ltd","Port Coquitlam",,"CA","Voluntary: Firm Initiated","Letter","Nationwide distribution.","F-1548-2013","Class I","vega sport, Natural Plant-Based Protein Bar; Chocolate Coconut flavor Gluten Free; 2.1 oz/ 60g Complete protein '' 4g of fiber per serving '' 0.4g of Omega-3 per serving Made in a facility that processes peanuts, tree nuts, sesame, dairy, and soy. May contain fruit shell or nut pieces. Distributed by Sequels Naturals LTD, Burnaby, BC, Canada UPC:838766008301","Lot codes: 12100U 13-May 12170U 13-Jul 12238U 13-Sep 12296U 13-Nov 12346 14-Jan 13037U 14-Mar ",,"59, 373 boxes, 3655 singles.","Raw material supplier of the chocolate used for the bar coating had milk ingredients added inadvertently. One report of ampholytic reaction.",6/7/2013,"06/07/2013",6/26/2013,"06/26/2013"
"Food",65412,"Ongoing","Sequel Naturals Ltd","Port Coquitlam",,"CA","Voluntary: Firm Initiated","Letter","Nationwide distribution.","F-1547-2013","Class I","vega one, all-in one nutrition bar; Double chocolate flavor Added vitamins and minerals; 15 g Protein, 6 g Fiber and 1.5 g Omega Antioxidants, probiotics & greens; Gluten Free Dietary Supplement. 2.2 oz/ 63g Made in a facility that processes peanuts, tree nuts, sesame, dairy, and soy. May contain fruit shell or nut pieces. Distributed by Sequels Naturals LTD, Burnaby, BC, Canada UPC:838766070032","Lot code: 13026U 14-Feb",,"1328 boxes, 808 singles","Raw material supplier of the chocolate used for the bar coating had milk ingredients added inadvertently. One report of ampholytic reaction.",6/7/2013,"06/07/2013",6/26/2013,"06/26/2013"
"Food",65412,"Ongoing","Sequel Naturals Ltd","Port Coquitlam",,"CA","Voluntary: Firm Initiated","Letter","Nationwide distribution.","F-1545-2013","Class I","vega one, all-in one nutrition bar; chocolate almond flavor Added vitamins and minerals; 15 g Protein, 6 g Fiber and 1.5 g Omega Antioxidants, probiotics & greens; Gluten Free Dietary Supplement. 2.2 oz/ 63g Made in a facility that processes peanuts, tree nuts, sesame, dairy, and soy. May contain fruit shell or nut pieces. Distributed by Sequels Naturals LTD, Burnaby, BC, Canada UPC: 838766070049","Lot code 13028U, Exp 14-Feb ",,"1515 boxes, 769 singles","Raw material supplier of the chocolate used for the bar coating had milk ingredients added inadvertently. One report of ampholytic reaction.",6/7/2013,"06/07/2013",6/26/2013,"06/26/2013"
"Food",65412,"Ongoing","Sequel Naturals Ltd","Port Coquitlam",,"CA","Voluntary: Firm Initiated","Letter","Nationwide distribution.","F-1549-2013","Class I","vega sport, Natural Plant-Based Protein Bar; Chocolate Saviseed flavor Gluten Free; 2.1 oz/ 60g Complete protein '' 4g of fiber per serving '' 0.4g of Omega-3 per serving Made in a facility that processes peanuts, tree nuts, sesame, dairy, and soy. May contain fruit shell or nut pieces. Distributed by Sequels Naturals LTD, Burnaby, BC, Canada UPC:838766008301","Lot codes: 12095U 13-May 12172U 13-Jul 12235U 13-Sep 12295U 13-Nov 12349 14-Jan 13038U 14-Mar ",,"36,764 boxes, 1771 singles.","Raw material supplier of the chocolate used for the bar coating had milk ingredients added inadvertently. One report of ampholytic reaction.",6/7/2013,"06/07/2013",6/26/2013,"06/26/2013"
"Food",65412,"Ongoing","Sequel Naturals Ltd","Port Coquitlam",,"CA","Voluntary: Firm Initiated","Letter","Nationwide distribution.","F-1546-2013","Class I","vega one, all-in one nutrition bar; chocolate cherry flavor Added vitamins and minerals; 15 g Protein, 6 g Fiber and 1.5 g Omega Antioxidants, probiotics & greens; Gluten Free Dietary Supplement. 2.2 oz/ 63g Made in a facility that processes peanuts, tree nuts, sesame, dairy, and soy. May contain fruit shell or nut pieces. Distributed by Sequels Naturals LTD, Burnaby, BC, Canada UPC: 838766070056","Lot code: 13032U, 14-Mar ",,"1292 boxes, 2734 singles","Raw material supplier of the chocolate used for the bar coating had milk ingredients added inadvertently. One report of ampholytic reaction.",6/7/2013,"06/07/2013",6/26/2013,"06/26/2013"
"Devices",65413,"Ongoing","Zimmer, Inc.","Warsaw","IN","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Worldwide Distribution-USA (nationwide) and the country of Japan.","Z-2030-2013","Class II","00597004109 Articular Surface CR ART SURF 56/STRIPE GREEN 9, Rx, Sterile; 00597004110 Articular Surface CR ART SURF 56/STRIPE GREEN 10, Rx, Sterile; 00597004112 Articular Surface CR ART SURF 56/STRIPE GREEN 12, Rx, Sterile; 00597004114 Articular Surface CR ART SURF 56/STRIPE GREEN 14, Rx, Sterile; 00597004117 Articular Surface CR ART SURF 56/STRIPE GREEN 17, Rx, Sterile; 00597004120 Articular Surface CR ART SURF 56/STRIPE GREEN 20, Rx, Sterile; 00597004123 Articular Surface CR ART SURF 56/STRIPE GREEN 23, Rx, Sterile; Used in total knee arthroplasty and indicated for patients with severe pain. "," all codes",".","192,355 all devices","Zimmer continuing investigation and monitoring of the NexGen Cruciate Retaining (CR) Complete Knee System found continued high rates of components used in combinations that are not approved (micro with standard) were implanted. This included the usage of CR Micro Femurs, CR Micro Articular Surface, CR Micro Patellae, CR Micro instruments and provisionals combined with standard components. Although the occurrence has been reduced since the March, 2012 recall, which reiterated proper combination labeling, it has not been eliminated and therefore Zimmer is initiating a recall to remove the affected devices and prevent this issue from recurring in all regions but Japan. ",6/7/2013,"06/07/2013",8/28/2013,"08/28/2013"
"Devices",65413,"Ongoing","Zimmer, Inc.","Warsaw","IN","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Worldwide Distribution-USA (nationwide) and the country of Japan.","Z-2031-2013","Class II","90597004109 Articular Surface CR ART SURF AE56/STR GRN 09MM, Rx, Sterile; 90597004110 Articular Surface CR ART SURF AE56/STR GRN 10MM, Rx, Sterile; 90597004112 Articular Surface CR ART SURF AE56/STR GRN 12MM, Rx, Sterile; 90597004114 Articular Surface CR ART SURF AE56/STR GRN 14MM, Rx, Sterile; 90597004117 Articular Surface CR ART SURF AE56/STR GRN 17MM, Rx, Sterile; 90597004120 Articular Surface CR ART SURF AE56/STR GRN 20MM, Rx, Sterile; Used in total knee arthroplasty and indicated for patients with severe pain."," all codes",".","192,355 all devices","Zimmer continuing investigation and monitoring of the NexGen Cruciate Retaining (CR) Complete Knee System found continued high rates of components used in combinations that are not approved (micro with standard) were implanted. This included the usage of CR Micro Femurs, CR Micro Articular Surface, CR Micro Patellae, CR Micro instruments and provisionals combined with standard components. Although the occurrence has been reduced since the March, 2012 recall, which reiterated proper combination labeling, it has not been eliminated and therefore Zimmer is initiating a recall to remove the affected devices and prevent this issue from recurring in all regions but Japan. ",6/7/2013,"06/07/2013",8/28/2013,"08/28/2013"
"Devices",65413,"Ongoing","Zimmer, Inc.","Warsaw","IN","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Worldwide Distribution-USA (nationwide) and the country of Japan.","Z-2037-2013","Class II","00597106126 Provisional ALL POLY PAT PROV MICRO SZ 26, Rx, Sterile; 00597106129 Provisional ALL POLY PAT PROV MICRO SZ 29, Rx, Sterile; 00597106132 Provisional ALL POLY PAT PROV MICRO SZ 32, Rx, Sterile; 00597106135 Provisional ALL POLY PAT PROV MICRO SZ 35, Rx, Sterile; Used in total knee arthroplasty and indicated for patients with severe pain."," all codes",".","192,355 all devices","Zimmer continuing investigation and monitoring of the NexGen Cruciate Retaining (CR) Complete Knee System found continued high rates of components used in combinations that are not approved (micro with standard) were implanted. This included the usage of CR Micro Femurs, CR Micro Articular Surface, CR Micro Patellae, CR Micro instruments and provisionals combined with standard components. Although the occurrence has been reduced since the March, 2012 recall, which reiterated proper combination labeling, it has not been eliminated and therefore Zimmer is initiating a recall to remove the affected devices and prevent this issue from recurring in all regions but Japan. ",6/7/2013,"06/07/2013",8/28/2013,"08/28/2013"
"Devices",65413,"Ongoing","Zimmer, Inc.","Warsaw","IN","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Worldwide Distribution-USA (nationwide) and the country of Japan.","Z-2044-2013","Class II","00597104110 Provisional CR ART SURF PROV 56/STR GRN 10, Rx, Sterile; 00597104112 Provisional CR ART SURF PROV 56/STR GRN 12, Rx, Sterile; 00597104114 Provisional CR ART SURF PROV 56/STR GRN 14, Rx, Sterile; 00597104117 Provisional CR ART SURF PROV 56/STR GRN 17, Rx, Sterile; 00597104120 Provisional CR ART SURF PROV 56/STR GRN 20, Rx, Sterile; 00597104123 Provisional CR ART SURF PROV 56/STR GRN 23, Rx, Sterile; Used in total knee arthroplasty and indicated for patients with severe pain."," all codes",".","192,355 all devices","Zimmer continuing investigation and monitoring of the NexGen Cruciate Retaining (CR) Complete Knee System found continued high rates of components used in combinations that are not approved (micro with standard) were implanted. This included the usage of CR Micro Femurs, CR Micro Articular Surface, CR Micro Patellae, CR Micro instruments and provisionals combined with standard components. Although the occurrence has been reduced since the March, 2012 recall, which reiterated proper combination labeling, it has not been eliminated and therefore Zimmer is initiating a recall to remove the affected devices and prevent this issue from recurring in all regions but Japan. ",6/7/2013,"06/07/2013",8/28/2013,"08/28/2013"
"Devices",65413,"Ongoing","Zimmer, Inc.","Warsaw","IN","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Worldwide Distribution-USA (nationwide) and the country of Japan.","Z-2020-2013","Class II","00597202009 Articular Surface CR ART SURF 12/PURPLE 09, Rx, Sterile; 00597202010 Articular Surface CR ART SURF 12/PURPLE 10, Rx, Sterile; 00597202012 Articular Surface CR ART SURF 12/PURPLE 12, Rx, Sterile; 00597202014 Articular Surface CR ART SURF 12/PURPLE 14, Rx, Sterile; 00597202017 Articular Surface CR ART SURF 12/PURPLE 17, Rx, Sterile; 00597202020 Articular Surface CR ART SURF 12/PURPLE 20, Rx, Sterile; 00597202023 Articular Surface CR ART SURF 12/PURPLE 23, Rx, Sterile; Used in total knee arthroplasty and indicated for patients with severe pain. "," all codes",".","192,355 all devices","Zimmer continuing investigation and monitoring of the NexGen Cruciate Retaining (CR) Complete Knee System found continued high rates of components used in combinations that are not approved (micro with standard) were implanted. This included the usage of CR Micro Femurs, CR Micro Articular Surface, CR Micro Patellae, CR Micro instruments and provisionals combined with standard components. Although the occurrence has been reduced since the March, 2012 recall, which reiterated proper combination labeling, it has not been eliminated and therefore Zimmer is initiating a recall to remove the affected devices and prevent this issue from recurring in all regions but Japan. ",6/7/2013,"06/07/2013",8/28/2013,"08/28/2013"
"Devices",65413,"Ongoing","Zimmer, Inc.","Warsaw","IN","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Worldwide Distribution-USA (nationwide) and the country of Japan.","Z-2010-2013","Class II","00597001333 Femur CR PRC SURF HDN FEM CO-NID CML Rx, Sterile; 00597001334 Femur CR PRC SURF HDN FEM CO-NID CMR Rx, Sterile; 00597001433 Femur CR PRC SURF HDN FEM CO-NID DML Rx, Sterile; 00597001434 Femur CR PRC SURF HDN FEM CO-NID DMR Rx, Sterile; 00597001533 Femur CR PRC SURF HDN FEM CO-NID EML Rx, Sterile; 00597001534 Femur CR PRC SURF HDN FEM CO-NID EMR Rx, Sterile; Used in total knee arthroplasty and indicated for patients with severe pain."," all codes",".","192,355 all devices","Zimmer continuing investigation and monitoring of the NexGen Cruciate Retaining (CR) Complete Knee System found continued high rates of components used in combinations that are not approved (micro with standard) were implanted. This included the usage of CR Micro Femurs, CR Micro Articular Surface, CR Micro Patellae, CR Micro instruments and provisionals combined with standard components. Although the occurrence has been reduced since the March, 2012 recall, which reiterated proper combination labeling, it has not been eliminated and therefore Zimmer is initiating a recall to remove the affected devices and prevent this issue from recurring in all regions but Japan. ",6/7/2013,"06/07/2013",8/28/2013,"08/28/2013"
"Devices",65413,"Ongoing","Zimmer, Inc.","Warsaw","IN","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Worldwide Distribution-USA (nationwide) and the country of Japan.","Z-2015-2013","Class II","00597206126 Patella ALL POLY PAT COMP MICRO 26DIA, Rx, Sterile; 00597206129 Patella ALL POLY PAT COMP MICRO 29DIA, Rx, Sterile; 00597206132 Patella ALL POLY PAT COMP MICRO 32DIA, Rx, Sterile; 00597206135 Patella ALL POLY PAT COMP MICRO 35DIA, Rx, Sterile; Used in total knee arthroplasty and indicated for patients with severe pain. "," all codes",".","192,355 all devices","Zimmer continuing investigation and monitoring of the NexGen Cruciate Retaining (CR) Complete Knee System found continued high rates of components used in combinations that are not approved (micro with standard) were implanted. This included the usage of CR Micro Femurs, CR Micro Articular Surface, CR Micro Patellae, CR Micro instruments and provisionals combined with standard components. Although the occurrence has been reduced since the March, 2012 recall, which reiterated proper combination labeling, it has not been eliminated and therefore Zimmer is initiating a recall to remove the affected devices and prevent this issue from recurring in all regions but Japan. ",6/7/2013,"06/07/2013",8/28/2013,"08/28/2013"
"Devices",65413,"Ongoing","Zimmer, Inc.","Warsaw","IN","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Worldwide Distribution-USA (nationwide) and the country of Japan.","Z-2011-2013","Class II","00597201303 Femur CR POR FM COMP SIZE CML Rx, Sterile; 00597201304 Femur CR POR FM COMP SIZE CMR Rx, Sterile; 00597201403 Femur CR POR FM COMP SIZE DML Rx, Sterile; 00597201404 Femur CR POR FM COMP SIZE DMR Rx, Sterile; 00597201503 Femur CR POR FM COMP SIZE EML Rx, Sterile; 00597201504 Femur CR POR FM COMP SIZE EMR Rx, Sterile; Used in total knee arthroplasty and indicated for patients with severe pain."," all codes",".","192,355 all devices","Zimmer continuing investigation and monitoring of the NexGen Cruciate Retaining (CR) Complete Knee System found continued high rates of components used in combinations that are not approved (micro with standard) were implanted. This included the usage of CR Micro Femurs, CR Micro Articular Surface, CR Micro Patellae, CR Micro instruments and provisionals combined with standard components. Although the occurrence has been reduced since the March, 2012 recall, which reiterated proper combination labeling, it has not been eliminated and therefore Zimmer is initiating a recall to remove the affected devices and prevent this issue from recurring in all regions but Japan. ",6/7/2013,"06/07/2013",8/28/2013,"08/28/2013"
"Devices",65413,"Ongoing","Zimmer, Inc.","Warsaw","IN","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Worldwide Distribution-USA (nationwide) and the country of Japan.","Z-2023-2013","Class II","90595203117 Articular Surface XLPE CR ART SURF AE34/STYEL 17, Rx, Sterile; 90595203120 Articular Surface XLPE CR ART SURF AE34/STYEL 20, Rx, Sterile; Used in total knee arthroplasty and indicated for patients with severe pain. "," all codes",".","192,355 all devices","Zimmer continuing investigation and monitoring of the NexGen Cruciate Retaining (CR) Complete Knee System found continued high rates of components used in combinations that are not approved (micro with standard) were implanted. This included the usage of CR Micro Femurs, CR Micro Articular Surface, CR Micro Patellae, CR Micro instruments and provisionals combined with standard components. Although the occurrence has been reduced since the March, 2012 recall, which reiterated proper combination labeling, it has not been eliminated and therefore Zimmer is initiating a recall to remove the affected devices and prevent this issue from recurring in all regions but Japan. ",6/7/2013,"06/07/2013",8/28/2013,"08/28/2013"
"Devices",65413,"Ongoing","Zimmer, Inc.","Warsaw","IN","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Worldwide Distribution-USA (nationwide) and the country of Japan.","Z-2009-2013","Class II","00597001303 Femur CR PRC FEM COMP SIZE CML Rx, Sterile; 00597001304 Femur CR PRC FEM COMP SIZE CMR Rx, Sterile; 00597001403 Femur CR PRC FEM COMP SIZE DML Rx, Sterile; 00597001404 Femur CR PRC FEM COMP SIZE DMR Rx, Sterile; 00597001503 Femur CR PRC FEM COMP SIZE EML Rx, Sterile; 00597001504 Femur CR PRC FEM COMP SIZE EMR Rx, Sterile; Used in total knee arthroplasty and indicated for patients with severe pain. "," all codes",".","192,355","Zimmer continuing investigation and monitoring of the NexGen Cruciate Retaining (CR) Complete Knee System found continued high rates of components used in combinations that are not approved (micro with standard) were implanted. This included the usage of CR Micro Femurs, CR Micro Articular Surface, CR Micro Patellae, CR Micro instruments and provisionals combined with standard components. Although the occurrence has been reduced since the March, 2012 recall, which reiterated proper combination labeling, it has not been eliminated and therefore Zimmer is initiating a recall to remove the affected devices and prevent this issue from recurring in all regions but Japan. ",6/7/2013,"06/07/2013",8/28/2013,"08/28/2013"
"Devices",65413,"Ongoing","Zimmer, Inc.","Warsaw","IN","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Worldwide Distribution-USA (nationwide) and the country of Japan.","Z-2040-2013","Class II","00597503110 Provisional AC ARTSURF PROV 34/STRIPE YEL10, Rx, Sterile; 00597503112 Provisional AC ARTSURF PROV 34/STRIPE YEL12, Rx, Sterile; 00597503114 Provisional AC ARTSURF PROV 34/STRIPE YEL14, Rx, Sterile; 00597503117 Provisional AC ARTSURF PROV 34/STRIPE YEL17, Rx, Sterile; 00597503120 Provisional AC ARTSURF PROV 34/STRIPE YEL 20, Rx, Sterile; 00597503123 Provisional AC ARTSURF PROV 34/STRIPE YEL 23, Rx, Sterile; Used in total knee arthroplasty and indicated for patients with severe pain. "," all codes",".","192,355 all devices","Zimmer continuing investigation and monitoring of the NexGen Cruciate Retaining (CR) Complete Knee System found continued high rates of components used in combinations that are not approved (micro with standard) were implanted. This included the usage of CR Micro Femurs, CR Micro Articular Surface, CR Micro Patellae, CR Micro instruments and provisionals combined with standard components. Although the occurrence has been reduced since the March, 2012 recall, which reiterated proper combination labeling, it has not been eliminated and therefore Zimmer is initiating a recall to remove the affected devices and prevent this issue from recurring in all regions but Japan. ",6/7/2013,"06/07/2013",8/28/2013,"08/28/2013"
"Devices",65413,"Ongoing","Zimmer, Inc.","Warsaw","IN","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Worldwide Distribution-USA (nationwide) and the country of Japan.","Z-2016-2013","Class II","00595202010 Articular Surface XLPE CR ART SURF 1,2/PUR 10, Rx, Sterile; 00595202012 Articular Surface XLPE CR ART SURF 1,2/PUR 12, Rx, Sterile; 00595202014 Articular Surface XLPE CR ART SURF 1,2/PUR 14, Rx, Sterile; 00595202017 Articular Surface XLPE CR ART SURF 1,2/PUR 17, Rx, Sterile; 00595202020 Articular Surface XLPE CR ART SURF 1,2/PUR 20, Rx, Sterile; Used in total knee arthroplasty and indicated for patients with severe pain. "," all codes",".","192,355 all devices","Zimmer continuing investigation and monitoring of the NexGen Cruciate Retaining (CR) Complete Knee System found continued high rates of components used in combinations that are not approved (micro with standard) were implanted. This included the usage of CR Micro Femurs, CR Micro Articular Surface, CR Micro Patellae, CR Micro instruments and provisionals combined with standard components. Although the occurrence has been reduced since the March, 2012 recall, which reiterated proper combination labeling, it has not been eliminated and therefore Zimmer is initiating a recall to remove the affected devices and prevent this issue from recurring in all regions but Japan. ",6/7/2013,"06/07/2013",8/28/2013,"08/28/2013"
"Devices",65413,"Ongoing","Zimmer, Inc.","Warsaw","IN","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Worldwide Distribution-USA (nationwide) and the country of Japan.","Z-2025-2013","Class II","90597003109 Articular Surface CR ART SURF 34/STR YEL 09MM, Rx, Sterile; 90597003110 Articular Surface CR ART SURF 34/STR YEL 10MM, Rx, Sterile; 90597003112 Articular Surface CR ART SURF 34/STR YEL 12MM, Rx, Sterile; 90597003114 Articular Surface CR ART SURF 34/STR YEL 14MM, Rx, Sterile; 90597003117 Articular Surface CR ART SURF 34/STR YEL 17MM, Rx, Sterile; 90597003120 Articular Surface CR ART SURF 34/STR YEL 20MM, Rx, Sterile; Used in total knee arthroplasty and indicated for patients with severe pain. "," all codes",".","192,355 all devices","Zimmer continuing investigation and monitoring of the NexGen Cruciate Retaining (CR) Complete Knee System found continued high rates of components used in combinations that are not approved (micro with standard) were implanted. This included the usage of CR Micro Femurs, CR Micro Articular Surface, CR Micro Patellae, CR Micro instruments and provisionals combined with standard components. Although the occurrence has been reduced since the March, 2012 recall, which reiterated proper combination labeling, it has not been eliminated and therefore Zimmer is initiating a recall to remove the affected devices and prevent this issue from recurring in all regions but Japan. ",6/7/2013,"06/07/2013",8/28/2013,"08/28/2013"
"Devices",65413,"Ongoing","Zimmer, Inc.","Warsaw","IN","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Worldwide Distribution-USA (nationwide) and the country of Japan.","Z-2026-2013","Class II","00597203109 Articular Surface CR ART SURF 34/STRIPE YEL 09, Rx, Sterile; 00597203110 Articular Surface CR ART SURF 34/STRIPE YEL 10, Rx, Sterile; 00597203112 Articular Surface CR ART SURF 34/STRIPE YEL 12, Rx, Sterile; 00597203114 Articular Surface CR ART SURF 34/STRIPE YEL 14, Rx, Sterile; 00597203117 Articular Surface CR ART SURF 34/STRIPE YEL 17, Rx, Sterile; 00597203120 Articular Surface CR ART SURF 34/STRIPE YEL 20, Rx, Sterile; 00597203123 Articular Surface CR ART SURF 34/STRIPE YEL 23, Rx, Sterile; Used in total knee arthroplasty and indicated for patients with severe pain. "," all codes",".","192,355 all devices","Zimmer continuing investigation and monitoring of the NexGen Cruciate Retaining (CR) Complete Knee System found continued high rates of components used in combinations that are not approved (micro with standard) were implanted. This included the usage of CR Micro Femurs, CR Micro Articular Surface, CR Micro Patellae, CR Micro instruments and provisionals combined with standard components. Although the occurrence has been reduced since the March, 2012 recall, which reiterated proper combination labeling, it has not been eliminated and therefore Zimmer is initiating a recall to remove the affected devices and prevent this issue from recurring in all regions but Japan. ",6/7/2013,"06/07/2013",8/28/2013,"08/28/2013"
"Devices",65413,"Ongoing","Zimmer, Inc.","Warsaw","IN","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Worldwide Distribution-USA (nationwide) and the country of Japan.","Z-2006-2013","Class II","00595001201 Femur CR-FLEX PCT FEM B-L Rx, Sterile; 00595001202 Femur CR-FLEX PCT FEM B-R Rx, Sterile; Used in total knee arthroplasty and indicated for patients with severe pain."," all codes",".","192,355","Zimmer continuing investigation and monitoring of the NexGen Cruciate Retaining (CR) Complete Knee System found continued high rates of components used in combinations that are not approved (micro with standard) were implanted. This included the usage of CR Micro Femurs, CR Micro Articular Surface, CR Micro Patellae, CR Micro instruments and provisionals combined with standard components. Although the occurrence has been reduced since the March, 2012 recall, which reiterated proper combination labeling, it has not been eliminated and therefore Zimmer is initiating a recall to remove the affected devices and prevent this issue from recurring in all regions but Japan. ",6/7/2013,"06/07/2013",8/28/2013,"08/28/2013"
"Devices",65413,"Ongoing","Zimmer, Inc.","Warsaw","IN","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Worldwide Distribution-USA (nationwide) and the country of Japan.","Z-2022-2013","Class II","00595203110 Articular Surface XLPE CR ART SURF 3,4/SYEL 10, Rx, Sterile; 00595203112 Articular Surface XLPE CR ART SURF 3,4/SYEL 12, Rx, Sterile; 00595203114 Articular Surface XLPE CR ART SURF 3,4/SYEL 14, Rx, Sterile; 00595203117 Articular Surface XLPE CR ART SURF 3,4/SYEL 17, Rx, Sterile; 00595203120 Articular Surface XLPE CR ART SURF 3,4/SYEL 20, Rx, Sterile; Used in total knee arthroplasty and indicated for patients with severe pain."," all codes",".","192,355 all devices","Zimmer continuing investigation and monitoring of the NexGen Cruciate Retaining (CR) Complete Knee System found continued high rates of components used in combinations that are not approved (micro with standard) were implanted. This included the usage of CR Micro Femurs, CR Micro Articular Surface, CR Micro Patellae, CR Micro instruments and provisionals combined with standard components. Although the occurrence has been reduced since the March, 2012 recall, which reiterated proper combination labeling, it has not been eliminated and therefore Zimmer is initiating a recall to remove the affected devices and prevent this issue from recurring in all regions but Japan. ",6/7/2013,"06/07/2013",8/28/2013,"08/28/2013"
"Devices",65413,"Ongoing","Zimmer, Inc.","Warsaw","IN","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Worldwide Distribution-USA (nationwide) and the country of Japan.","Z-2014-2013","Class II","00587806126 Patella MICRO POROUS PAT 26MM X 10MM, Rx, Sterile; 00587806129 Patella MICRO POROUS PAT 29MM X 10MM, Rx, Sterile; 00587806132 Patella MICRO POROUS PAT 32MM X 10MM, Rx, Sterile; 00587806135 Patella MICRO POROUS PAT 35MM X 10MM, Rx, Sterile; Used in total knee arthroplasty and indicated for patients with severe pain. "," all codes",".","192,355 all devices","Zimmer continuing investigation and monitoring of the NexGen Cruciate Retaining (CR) Complete Knee System found continued high rates of components used in combinations that are not approved (micro with standard) were implanted. This included the usage of CR Micro Femurs, CR Micro Articular Surface, CR Micro Patellae, CR Micro instruments and provisionals combined with standard components. Although the occurrence has been reduced since the March, 2012 recall, which reiterated proper combination labeling, it has not been eliminated and therefore Zimmer is initiating a recall to remove the affected devices and prevent this issue from recurring in all regions but Japan. ",6/7/2013,"06/07/2013",8/28/2013,"08/28/2013"
"Devices",65413,"Ongoing","Zimmer, Inc.","Warsaw","IN","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Worldwide Distribution-USA (nationwide) and the country of Japan.","Z-2041-2013","Class II","00597504110 Provisional AC ART SURF PROV 56/STR GRN 10, Rx, Sterile; 00597504112 Provisional AC ART SURF PROV 56/STR GRN 12, Rx, Sterile; 00597504114 Provisional AC ART SURF PROV 56/STR GRN 14, Rx, Sterile; 00597504117 Provisional AC ART SURF PROV 56/STR GRN 17, Rx, Sterile; 00597504120 Provisional AC ART SURF PROV 56/STR GRN 20, Rx, Sterile; 00597504123 Provisional AC ART SURF PROV 56/STR GRN 23, Rx, Sterile; Used in total knee arthroplasty and indicated for patients with severe pain. "," all codes",".","192,355 all devices","Zimmer continuing investigation and monitoring of the NexGen Cruciate Retaining (CR) Complete Knee System found continued high rates of components used in combinations that are not approved (micro with standard) were implanted. This included the usage of CR Micro Femurs, CR Micro Articular Surface, CR Micro Patellae, CR Micro instruments and provisionals combined with standard components. Although the occurrence has been reduced since the March, 2012 recall, which reiterated proper combination labeling, it has not been eliminated and therefore Zimmer is initiating a recall to remove the affected devices and prevent this issue from recurring in all regions but Japan. ",6/7/2013,"06/07/2013",8/28/2013,"08/28/2013"
"Devices",65413,"Ongoing","Zimmer, Inc.","Warsaw","IN","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Worldwide Distribution-USA (nationwide) and the country of Japan.","Z-2003-2013","Class II","65597201101 Femur CR POR FEM HATCP SIZE AML Rx, Sterile; 65597201102 Femur CR POR FEM HATCP SIZE AMR Rx, Sterile; 65597201201 Femur CR POR FEM HATCP SIZE BML Rx, Sterile; 65597201202 Femur CR POR FEM HATCP SIZE BMR Rx, Sterile; Used in total knee arthroplasty and indicated for patients with severe pain."," all codes",".","192,355 all devices","Zimmer continuing investigation and monitoring of the NexGen Cruciate Retaining (CR) Complete Knee System found continued high rates of components used in combinations that are not approved (micro with standard) were implanted. This included the usage of CR Micro Femurs, CR Micro Articular Surface, CR Micro Patellae, CR Micro instruments and provisionals combined with standard components. Although the occurrence has been reduced since the March, 2012 recall, which reiterated proper combination labeling, it has not been eliminated and therefore Zimmer is initiating a recall to remove the affected devices and prevent this issue from recurring in all regions but Japan. ",6/7/2013,"06/07/2013",8/28/2013,"08/28/2013"
"Devices",65413,"Ongoing","Zimmer, Inc.","Warsaw","IN","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Worldwide Distribution-USA (nationwide) and the country of Japan.","Z-2000-2013","Class II","00597201101 Femur CR POROUS FEM COMP SIZE AML Rx, Sterile; 00597201102 Femur CR POROUS FEM COMP SIZE AMR Rx, Sterile; 00597201201 Femur CR POROUS FEM COMP SIZE BML Rx, Sterile; 00597201202 Femur CR POROUS FEM COMP SIZE BMR Rx, Sterile; Used in total knee arthroplasty and indicated for patients with severe pain."," all codes",".","192,355 all devices","Zimmer continuing investigation and monitoring of the NexGen Cruciate Retaining (CR) Complete Knee System found continued high rates of components used in combinations that are not approved (micro with standard) were implanted. This included the usage of CR Micro Femurs, CR Micro Articular Surface, CR Micro Patellae, CR Micro instruments and provisionals combined with standard components. Although the occurrence has been reduced since the March, 2012 recall, which reiterated proper combination labeling, it has not been eliminated and therefore Zimmer is initiating a recall to remove the affected devices and prevent this issue from recurring in all regions but Japan. ",6/7/2013,"06/07/2013",8/28/2013,"08/28/2013"
"Devices",65413,"Ongoing","Zimmer, Inc.","Warsaw","IN","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Worldwide Distribution-USA (nationwide) and the country of Japan.","Z-2024-2013","Class II","00597003109 Articular Surface CR ART SURF 34/STRIPE YEL 9, Rx, Sterile; 00597003110 Articular Surface CR ART SURF 34/STRIPE YEL 10, Rx, Sterile; 00597003112 Articular Surface CR ART SURF 34/STRIPE YEL 12, Rx, Sterile; 00597003114 Articular Surface CR ART SURF 34/STRIPE YEL 14, Rx, Sterile; 00597003117 Articular Surface CR ART SURF 34/STRIPE YEL 17, Rx, Sterile; 00597003120 Articular Surface CR ART SURF 34/STRIPE YEL 20, Rx, Sterile; 00597003123 Articular Surface CR ART SURF 34/STRIPE YEL 23, Rx, Sterile; Used in total knee arthroplasty and indicated for patients with severe pain. "," all codes",".","192,355 all devices","Zimmer continuing investigation and monitoring of the NexGen Cruciate Retaining (CR) Complete Knee System found continued high rates of components used in combinations that are not approved (micro with standard) were implanted. This included the usage of CR Micro Femurs, CR Micro Articular Surface, CR Micro Patellae, CR Micro instruments and provisionals combined with standard components. Although the occurrence has been reduced since the March, 2012 recall, which reiterated proper combination labeling, it has not been eliminated and therefore Zimmer is initiating a recall to remove the affected devices and prevent this issue from recurring in all regions but Japan. ",6/7/2013,"06/07/2013",8/28/2013,"08/28/2013"
"Devices",65413,"Ongoing","Zimmer, Inc.","Warsaw","IN","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Worldwide Distribution-USA (nationwide) and the country of Japan.","Z-2028-2013","Class II","00595204110 Articular Surface XLPE CR ART SURF 5-6/STRGRN 10, Rx, Sterile; 00595204112 Articular Surface XLPE CR ART SURF 5-6/STRGRN 12, Rx, Sterile; 00595204114 Articular Surface XLPE CR ART SURF 5-6/STRGRN 14, Rx, Sterile; 00595204117 Articular Surface XLPE CR ART SURF 5-6/STRGRN 17, Rx, Sterile; 00595204120 Articular Surface XLPE CR ART SURF 5-6/STRGRN 20, Rx, Sterile; Used in total knee arthroplasty and indicated for patients with severe pain."," all codes",".","192,355 all devices","Zimmer continuing investigation and monitoring of the NexGen Cruciate Retaining (CR) Complete Knee System found continued high rates of components used in combinations that are not approved (micro with standard) were implanted. This included the usage of CR Micro Femurs, CR Micro Articular Surface, CR Micro Patellae, CR Micro instruments and provisionals combined with standard components. Although the occurrence has been reduced since the March, 2012 recall, which reiterated proper combination labeling, it has not been eliminated and therefore Zimmer is initiating a recall to remove the affected devices and prevent this issue from recurring in all regions but Japan. ",6/7/2013,"06/07/2013",8/28/2013,"08/28/2013"
"Devices",65413,"Ongoing","Zimmer, Inc.","Warsaw","IN","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Worldwide Distribution-USA (nationwide) and the country of Japan.","Z-2018-2013","Class II","00597002009 Articular Surface CR ART SURF 12/PURPLE 9, Rx, Sterile; 00597002010 Articular Surface CR ART SURF 12/PURPLE 10, Rx, Sterile; 00597002012 Articular Surface CR ART SURF 12/PURPLE 12, Rx, Sterile; 00597002014 Articular Surface CR ART SURF 12/PURPLE 14, Rx, Sterile; 00597002017 Articular Surface CR ART SURF 12/PURPLE 17, Rx, Sterile; 00597002020 Articular Surface CR ART SURF 12/PURPLE 20, Rx, Sterile; 00597002023 Articular Surface CR ART SURF 12/PURPLE 23, Rx, Sterile; Used in total knee arthroplasty and indicated for patients with severe pain. "," all codes",".","192,355 all devices","Zimmer continuing investigation and monitoring of the NexGen Cruciate Retaining (CR) Complete Knee System found continued high rates of components used in combinations that are not approved (micro with standard) were implanted. This included the usage of CR Micro Femurs, CR Micro Articular Surface, CR Micro Patellae, CR Micro instruments and provisionals combined with standard components. Although the occurrence has been reduced since the March, 2012 recall, which reiterated proper combination labeling, it has not been eliminated and therefore Zimmer is initiating a recall to remove the affected devices and prevent this issue from recurring in all regions but Japan. ",6/7/2013,"06/07/2013",8/28/2013,"08/28/2013"
"Devices",65413,"Ongoing","Zimmer, Inc.","Warsaw","IN","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Worldwide Distribution-USA (nationwide) and the country of Japan.","Z-2034-2013","Class II","00597101101 Provisional CR PROV FRM COMP SIZE AML, Rx, Sterile; 00597101102 Provisional CR PROV FRM COMP SIZE AMR, Rx, Sterile; 00597101201 Provisional CR PROV FRM COMP SIZE BML, Rx, Sterile; 00597101202 Provisional CR PROV FRM COMP SIZE BMR, Rx, Sterile; 00597101303 Provisional CR PROV FRM COMP SIZE CML, Rx, Sterile; 00597101304 Provisional CR PROV FRM COMP SIZE CMR, Rx, Sterile; 00597101403 Provisional CR PROV FRM COMP SIZE DML, Rx, Sterile; 00597101404 Provisional CR PROV FRM COMP SIZE DMR, Rx, Sterile; 00597101503 Provisional CR PROV FRM COMP SIZE EML, Rx, Sterile; 00597101504 Provisional CR PROV FRM COMP SIZE EMR, Rx, Sterile; Used in total knee arthroplasty and indicated for patients with severe pain. "," all codes",".","192,355 all devices","Zimmer continuing investigation and monitoring of the NexGen Cruciate Retaining (CR) Complete Knee System found continued high rates of components used in combinations that are not approved (micro with standard) were implanted. This included the usage of CR Micro Femurs, CR Micro Articular Surface, CR Micro Patellae, CR Micro instruments and provisionals combined with standard components. Although the occurrence has been reduced since the March, 2012 recall, which reiterated proper combination labeling, it has not been eliminated and therefore Zimmer is initiating a recall to remove the affected devices and prevent this issue from recurring in all regions but Japan. ",6/7/2013,"06/07/2013",8/28/2013,"08/28/2013"
"Devices",65413,"Ongoing","Zimmer, Inc.","Warsaw","IN","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Worldwide Distribution-USA (nationwide) and the country of Japan.","Z-2043-2013","Class II","00597103110 Provisional CR ART SURF PROV 34/STR YEL 10, Rx, Sterile; 00597103112 Provisional CR ART SURF PROV 34/STR YEL 12, Rx, Sterile; 00597103114 Provisional CR ART SURF PROV 34/STR YEL 14, Rx, Sterile; 00597103117 Provisional CR ART SURF PROV 34/STR YEL 17, Rx, Sterile; 00597103120 Provisional CR ART SURF PROV 34/STR YEL 20, Rx, Sterile; 00597103123 Provisional CR ART SURF PROV 34/STR YEL 23, Rx, Sterile; Used in total knee arthroplasty and indicated for patients with severe pain. "," all codes",".","192,355 all devices","Zimmer continuing investigation and monitoring of the NexGen Cruciate Retaining (CR) Complete Knee System found continued high rates of components used in combinations that are not approved (micro with standard) were implanted. This included the usage of CR Micro Femurs, CR Micro Articular Surface, CR Micro Patellae, CR Micro instruments and provisionals combined with standard components. Although the occurrence has been reduced since the March, 2012 recall, which reiterated proper combination labeling, it has not been eliminated and therefore Zimmer is initiating a recall to remove the affected devices and prevent this issue from recurring in all regions but Japan. ",6/7/2013,"06/07/2013",8/28/2013,"08/28/2013"
"Devices",65413,"Ongoing","Zimmer, Inc.","Warsaw","IN","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Worldwide Distribution-USA (nationwide) and the country of Japan.","Z-2039-2013","Class II","00597502010 Provisional AC ART SURF PROV 12/PUR 10, Rx, Sterile; 00597502012 Provisional AC ART SURF PROV 12/PUR 12, Rx, Sterile; 00597502014 Provisional AC ART SURF PROV 12/PUR 14, Rx, Sterile; 00597502017 Provisional AC ART SURF PROV 12/PUR 17, Rx, Sterile; 00597502020 Provisional AC ART SURF PROV 12/PUR 20, Rx, Sterile; 00597502023 Provisional AC ART SURF PROV 12/PUR 23, Rx, Sterile; Used in total knee arthroplasty and indicated for patients with severe pain. "," all codes",".","192,355 all devices","Zimmer continuing investigation and monitoring of the NexGen Cruciate Retaining (CR) Complete Knee System found continued high rates of components used in combinations that are not approved (micro with standard) were implanted. This included the usage of CR Micro Femurs, CR Micro Articular Surface, CR Micro Patellae, CR Micro instruments and provisionals combined with standard components. Although the occurrence has been reduced since the March, 2012 recall, which reiterated proper combination labeling, it has not been eliminated and therefore Zimmer is initiating a recall to remove the affected devices and prevent this issue from recurring in all regions but Japan. ",6/7/2013,"06/07/2013",8/28/2013,"08/28/2013"
"Devices",65413,"Ongoing","Zimmer, Inc.","Warsaw","IN","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Worldwide Distribution-USA (nationwide) and the country of Japan.","Z-2035-2013","Class II","00595501201 Provisional CR-FLEX FEM PROV SZ B-L, Rx, Sterile; 00595501202 Provisional CR-FLEX FEM PROV SZ B-R, Rx, Sterile; Used in total knee arthroplasty and indicated for patients with severe pain. "," all codes",".","192,355 all devices","Zimmer continuing investigation and monitoring of the NexGen Cruciate Retaining (CR) Complete Knee System found continued high rates of components used in combinations that are not approved (micro with standard) were implanted. This included the usage of CR Micro Femurs, CR Micro Articular Surface, CR Micro Patellae, CR Micro instruments and provisionals combined with standard components. Although the occurrence has been reduced since the March, 2012 recall, which reiterated proper combination labeling, it has not been eliminated and therefore Zimmer is initiating a recall to remove the affected devices and prevent this issue from recurring in all regions but Japan. ",6/7/2013,"06/07/2013",8/28/2013,"08/28/2013"
"Devices",65413,"Ongoing","Zimmer, Inc.","Warsaw","IN","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Worldwide Distribution-USA (nationwide) and the country of Japan.","Z-2029-2013","Class II","90595204117 Articular Surface XLPE CR ART SURF AE56/STGRN 17, Rx, Sterile; 90595204120 Articular Surface XLPE CR ART SURF AE56/STGRN 20, Rx, Sterile; Used in total knee arthroplasty and indicated for patients with severe pain. "," all codes",".","192,355 all devices","Zimmer continuing investigation and monitoring of the NexGen Cruciate Retaining (CR) Complete Knee System found continued high rates of components used in combinations that are not approved (micro with standard) were implanted. This included the usage of CR Micro Femurs, CR Micro Articular Surface, CR Micro Patellae, CR Micro instruments and provisionals combined with standard components. Although the occurrence has been reduced since the March, 2012 recall, which reiterated proper combination labeling, it has not been eliminated and therefore Zimmer is initiating a recall to remove the affected devices and prevent this issue from recurring in all regions but Japan. ",6/7/2013,"06/07/2013",8/28/2013,"08/28/2013"
"Devices",65413,"Ongoing","Zimmer, Inc.","Warsaw","IN","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Worldwide Distribution-USA (nationwide) and the country of Japan.","Z-2013-2013","Class II","65597201333 Femur CR POR FEM SURF HDN HATCP CML, Rx, Sterile; 65597201334 Femur CR POR FEM SURF HDN HATCP CMR, Rx, Sterile; 65597201433 Femur CR POR FEM SURF HDN HATCP DML, Rx, Sterile; 65597201434 Femur CR POR FEM SURF HDN HATCP DMR, Rx, Sterile; 65597201533 Femur CR POR FEM SURF HDN HATCP EML, Rx, Sterile; 65597201534 Femur CR POR FEM SURF HDN HATCP EMR, Rx, Sterile; Used in total knee arthroplasty and indicated for patients with severe pain."," all codes",".","192,355 all devices","Zimmer continuing investigation and monitoring of the NexGen Cruciate Retaining (CR) Complete Knee System found continued high rates of components used in combinations that are not approved (micro with standard) were implanted. This included the usage of CR Micro Femurs, CR Micro Articular Surface, CR Micro Patellae, CR Micro instruments and provisionals combined with standard components. Although the occurrence has been reduced since the March, 2012 recall, which reiterated proper combination labeling, it has not been eliminated and therefore Zimmer is initiating a recall to remove the affected devices and prevent this issue from recurring in all regions but Japan. ",6/7/2013,"06/07/2013",8/28/2013,"08/28/2013"
"Devices",65413,"Ongoing","Zimmer, Inc.","Warsaw","IN","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Worldwide Distribution-USA (nationwide) and the country of Japan.","Z-2005-2013","Class II","00595601201 Femur CR-FLEX OPT FEM B-L Rx Sterile; 00595601202 Femur CR-FLEX OPT FEM B-R Rx Sterile; Used in total knee arthroplasty and indicated for patients with severe pain.","all codes",".","192,355 all devices","Zimmer continuing investigation and monitoring of the NexGen Cruciate Retaining (CR) Complete Knee System found continued high rates of components used in combinations that are not approved (micro with standard) were implanted. This included the usage of CR Micro Femurs, CR Micro Articular Surface, CR Micro Patellae, CR Micro instruments and provisionals combined with standard components. Although the occurrence has been reduced since the March, 2012 recall, which reiterated proper combination labeling, it has not been eliminated and therefore Zimmer is initiating a recall to remove the affected devices and prevent this issue from recurring in all regions but Japan. ",6/7/2013,"06/07/2013",8/28/2013,"08/28/2013"
"Devices",65413,"Ongoing","Zimmer, Inc.","Warsaw","IN","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Worldwide Distribution-USA (nationwide) and the country of Japan.","Z-1999-2013","Class II","00597001131 Femur CR PRC SURF HDN FEM CO-NID AML, Rx, Sterile; 00597001132 Femur CR PRC SURF HDN FEM CO-NID AMR, Rx, Sterile; 00597001231 Femur CR PRC SURF HDN FEM CO-NID BML, Rx, Sterile; 00597001232 Femur CR PRC SURF HDN FEM CO-NID BMR, Rx, Sterile; Used in total knee arthroplasty and indicated for patients with severe pain.","all codes",".","192,355 all devices","Zimmer continuing investigation and monitoring of the NexGen Cruciate Retaining (CR) Complete Knee System found continued high rates of components used in combinations that are not approved (micro with standard) were implanted. This included the usage of CR Micro Femurs, CR Micro Articular Surface, CR Micro Patellae, CR Micro instruments and provisionals combined with standard components. Although the occurrence has been reduced since the March, 2012 recall, which reiterated proper combination labeling, it has not been eliminated and therefore Zimmer is initiating a recall to remove the affected devices and prevent this issue from recurring in all regions but Japan. ",6/7/2013,"06/07/2013",8/28/2013,"08/28/2013"
"Devices",65413,"Ongoing","Zimmer, Inc.","Warsaw","IN","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Worldwide Distribution-USA (nationwide) and the country of Japan.","Z-2019-2013","Class II","90597002009 Articular Surface CR ART SURF 12/PURPLE 09MM, Rx, Sterile; 90597002010 Articular Surface CR ART SURF 12/PURPLE 10MM, Rx, Sterile; 90597002012 Articular Surface CR ART SURF 12/PURPLE 12MM, Rx, Sterile; 90597002014 Articular Surface CR ART SURF 12/PURPLE 14MM, Rx, Sterile; 90597002017 Articular Surface CR ART SURF 12/PURPLE 17MM, Rx, Sterile; 90597002020 Articular Surface CR ART SURF 12/PURPLE 20MM, Rx, Sterile; Used in total knee arthroplasty and indicated for patients with severe pain."," all codes",".","192,355 all devices","Zimmer continuing investigation and monitoring of the NexGen Cruciate Retaining (CR) Complete Knee System found continued high rates of components used in combinations that are not approved (micro with standard) were implanted. This included the usage of CR Micro Femurs, CR Micro Articular Surface, CR Micro Patellae, CR Micro instruments and provisionals combined with standard components. Although the occurrence has been reduced since the March, 2012 recall, which reiterated proper combination labeling, it has not been eliminated and therefore Zimmer is initiating a recall to remove the affected devices and prevent this issue from recurring in all regions but Japan. ",6/7/2013,"06/07/2013",8/28/2013,"08/28/2013"
"Devices",65413,"Ongoing","Zimmer, Inc.","Warsaw","IN","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Worldwide Distribution-USA (nationwide) and the country of Japan.","Z-2002-2013","Class II","00597201131 Femur CR POR SURF HDN FEM CO-NID AML Rx, Sterile; 00597201132 Femur CR POR SURF HDN FEM CO-NID AMR Rx, Sterile; 00597201231 Femur CR POR SURF HDN FEM CO-NID BML Rx, Sterile; 00597201232 Femur CR POR SURF HDN FEM CO-NID BMR Rx, Sterile; Used in total knee arthroplasty and indicated for patients with severe pain."," all codes",".","192,355 all devices","Zimmer continuing investigation and monitoring of the NexGen Cruciate Retaining (CR) Complete Knee System found continued high rates of components used in combinations that are not approved (micro with standard) were implanted. This included the usage of CR Micro Femurs, CR Micro Articular Surface, CR Micro Patellae, CR Micro instruments and provisionals combined with standard components. Although the occurrence has been reduced since the March, 2012 recall, which reiterated proper combination labeling, it has not been eliminated and therefore Zimmer is initiating a recall to remove the affected devices and prevent this issue from recurring in all regions but Japan. ",6/7/2013,"06/07/2013",8/28/2013,"08/28/2013"
"Devices",65413,"Ongoing","Zimmer, Inc.","Warsaw","IN","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Worldwide Distribution-USA (nationwide) and the country of Japan.","Z-2001-2013","Class II","65597201131 Femur CR POR FEM SURF HDN HATCP AML Rx, Sterile; 65597201132 Femur CR POR FEM SURF HDN HATCP AMR Rx, Sterile; 65597201231 Femur CR POR FEM SURF HDN HATCP BML Rx, Sterile; 65597201232 Femur CR POR FEM SURF HDN HATCP BMR Rx, Sterile; Used in total knee arthroplasty and indicated for patients with severe pain."," all codes",".","192,355","Zimmer continuing investigation and monitoring of the NexGen Cruciate Retaining (CR) Complete Knee System found continued high rates of components used in combinations that are not approved (micro with standard) were implanted. This included the usage of CR Micro Femurs, CR Micro Articular Surface, CR Micro Patellae, CR Micro instruments and provisionals combined with standard components. Although the occurrence has been reduced since the March, 2012 recall, which reiterated proper combination labeling, it has not been eliminated and therefore Zimmer is initiating a recall to remove the affected devices and prevent this issue from recurring in all regions but Japan. ",6/7/2013,"06/07/2013",8/28/2013,"08/28/2013"
"Devices",65413,"Ongoing","Zimmer, Inc.","Warsaw","IN","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Worldwide Distribution-USA (nationwide) and the country of Japan.","Z-1998-2013","Class II","00597001101 Femur CR PRECOAT FEM COMP SIZE AML, Rx, Sterile; 00597001102 Femur CR PRECOAT FEM COMP SIZE AMR, Rx, Sterile; 00597001201 Femur CR PRECOAT FEM COMP SIZE BML, Rx, Sterile; 00597001202 Femur CR PRECOAT FEM COMP SIZE BMR, Rx, Sterile. Used in total knee arthroplasty and indicated for patients with severe pain. ","REF 00597001101, all codes",".","192,355 all devices","Zimmer continuing investigation and monitoring of the NexGen Cruciate Retaining (CR) Complete Knee System found continued high rates of components used in combinations that are not approved (micro with standard) were implanted. This included the usage of CR Micro Femurs, CR Micro Articular Surface, CR Micro Patellae, CR Micro instruments and provisionals combined with standard components. Although the occurrence has been reduced since the March, 2012 recall, which reiterated proper combination labeling, it has not been eliminated and therefore Zimmer is initiating a recall to remove the affected devices and prevent this issue from recurring in all regions but Japan. ",6/7/2013,"06/07/2013",8/28/2013,"08/28/2013"
"Devices",65413,"Ongoing","Zimmer, Inc.","Warsaw","IN","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Worldwide Distribution-USA (nationwide) and the country of Japan.","Z-2032-2013","Class II","00597204109 Articular Surface CR ART SURF 56/STRIPE GRN 9, Rx, Sterile; 00597204110 Articular Surface CR ART SURF 56/STRIPE GRN 10, Rx, Sterile; 00597204112 Articular Surface CR ART SURF 56/STRIPE GRN 12, Rx, Sterile; 00597204114 Articular Surface CR ART SURF 56/STRIPE GRN 14, Rx, Sterile; 00597204117 Articular Surface CR ART SURF 56/STRIPE GRN 17, Rx, Sterile; 00597204120 Articular Surface CR ART SURF 56/STRIPE GRN 20, Rx, Sterile; 00597204123 Articular Surface CR ART SURF 56/STRIPE GRN 23, Rx, Sterile; Used in total knee arthroplasty and indicated for patients with severe pain."," all codes",".","192,355 all devices","Zimmer continuing investigation and monitoring of the NexGen Cruciate Retaining (CR) Complete Knee System found continued high rates of components used in combinations that are not approved (micro with standard) were implanted. This included the usage of CR Micro Femurs, CR Micro Articular Surface, CR Micro Patellae, CR Micro instruments and provisionals combined with standard components. Although the occurrence has been reduced since the March, 2012 recall, which reiterated proper combination labeling, it has not been eliminated and therefore Zimmer is initiating a recall to remove the affected devices and prevent this issue from recurring in all regions but Japan. ",6/7/2013,"06/07/2013",8/28/2013,"08/28/2013"
"Devices",65413,"Ongoing","Zimmer, Inc.","Warsaw","IN","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Worldwide Distribution-USA (nationwide) and the country of Japan.","Z-2021-2013","Class II","00597602010 Articular Surface AC ART SURF 12/PUR 10, Rx, Sterile; 00597602012 Articular Surface AC ART SURF 12/PUR 12, Rx, Sterile; 00597602014 Articular Surface AC ART SURF 12/PUR 14, Rx, Sterile; 00597602017 Articular Surface AC ART SURF 12/PUR 17, Rx, Sterile; 00597602020 Articular Surface AC ART SURF 12/PUR 20, Rx, Sterile; 00597602023 Articular Surface AC ART SURF 12/PUR 23, Rx, Sterile; Used in total knee arthroplasty and indicated for patients with severe pain. "," all codes",".","192,355 all devices","Zimmer continuing investigation and monitoring of the NexGen Cruciate Retaining (CR) Complete Knee System found continued high rates of components used in combinations that are not approved (micro with standard) were implanted. This included the usage of CR Micro Femurs, CR Micro Articular Surface, CR Micro Patellae, CR Micro instruments and provisionals combined with standard components. Although the occurrence has been reduced since the March, 2012 recall, which reiterated proper combination labeling, it has not been eliminated and therefore Zimmer is initiating a recall to remove the affected devices and prevent this issue from recurring in all regions but Japan. ",6/7/2013,"06/07/2013",8/28/2013,"08/28/2013"
"Devices",65413,"Ongoing","Zimmer, Inc.","Warsaw","IN","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Worldwide Distribution-USA (nationwide) and the country of Japan.","Z-2017-2013","Class II","90595202017 Articular Surface XLPE CR ART SURF AE12/PUR 17, Rx, Sterile; 90595202020 Articular Surface XLPE CR ART SURF AE12/PUR 20, Rx, Sterile; Used in total knee arthroplasty and indicated for patients with severe pain. "," all codes",".","192,355 all devices","Zimmer continuing investigation and monitoring of the NexGen Cruciate Retaining (CR) Complete Knee System found continued high rates of components used in combinations that are not approved (micro with standard) were implanted. This included the usage of CR Micro Femurs, CR Micro Articular Surface, CR Micro Patellae, CR Micro instruments and provisionals combined with standard components. Although the occurrence has been reduced since the March, 2012 recall, which reiterated proper combination labeling, it has not been eliminated and therefore Zimmer is initiating a recall to remove the affected devices and prevent this issue from recurring in all regions but Japan. ",6/7/2013,"06/07/2013",8/28/2013,"08/28/2013"
"Devices",65413,"Ongoing","Zimmer, Inc.","Warsaw","IN","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Worldwide Distribution-USA (nationwide) and the country of Japan.","Z-2012-2013","Class II","00597201333 Femur CR POR SURF HDN FEM CO-NID CML, Rx, Sterile; 00597201334 Femur CR POR SURF HDN FEM CO-NID CMR, Rx, Sterile; 00597201433 Femur CR POR SURF HDN FEM CO-NID DML, Rx, Sterile; 00597201434 Femur CR POR SURF HDN FEM CO-NID DMR, Rx, Sterile; 00597201533 Femur CR POR SURF HDN FEM CO-NID EML, Rx, Sterile; 00597201534 Femur CR POR SURF HDN FEM CO-NID EMR, Rx, Sterile; Used in total knee arthroplasty and indicated for patients with severe pain."," all codes",".","192,355 all devices","Zimmer continuing investigation and monitoring of the NexGen Cruciate Retaining (CR) Complete Knee System found continued high rates of components used in combinations that are not approved (micro with standard) were implanted. This included the usage of CR Micro Femurs, CR Micro Articular Surface, CR Micro Patellae, CR Micro instruments and provisionals combined with standard components. Although the occurrence has been reduced since the March, 2012 recall, which reiterated proper combination labeling, it has not been eliminated and therefore Zimmer is initiating a recall to remove the affected devices and prevent this issue from recurring in all regions but Japan. ",6/7/2013,"06/07/2013",8/28/2013,"08/28/2013"
"Devices",65413,"Ongoing","Zimmer, Inc.","Warsaw","IN","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Worldwide Distribution-USA (nationwide) and the country of Japan.","Z-2007-2013","Class II","00595201201 Femur CR-FLEX POR FEM B-L Rx, Sterile; 00595201202 Femur CR-FLEX POR FEM B-R Rx, Sterile; Used in total knee arthroplasty and indicated for patients with severe pain."," all codes",".","192,355 all devices","Zimmer continuing investigation and monitoring of the NexGen Cruciate Retaining (CR) Complete Knee System found continued high rates of components used in combinations that are not approved (micro with standard) were implanted. This included the usage of CR Micro Femurs, CR Micro Articular Surface, CR Micro Patellae, CR Micro instruments and provisionals combined with standard components. Although the occurrence has been reduced since the March, 2012 recall, which reiterated proper combination labeling, it has not been eliminated and therefore Zimmer is initiating a recall to remove the affected devices and prevent this issue from recurring in all regions but Japan. ",6/7/2013,"06/07/2013",8/28/2013,"08/28/2013"
"Devices",65413,"Ongoing","Zimmer, Inc.","Warsaw","IN","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Worldwide Distribution-USA (nationwide) and the country of Japan.","Z-2027-2013","Class II","00597603110 Articular Surface AC ART SURF 34/STRIPED YEL 10, Rx, Sterile; 00597603112 Articular Surface AC ART SURF 34/STRIPED YEL 12, Rx, Sterile; 00597603110 Articular Surface AC ART SURF 34/STRIPED YEL 10, Rx, Sterile; 00597603110 Articular Surface AC ART SURF 34/STRIPED YEL 10, Rx, Sterile; 00597603110 Articular Surface AC ART SURF 34/STRIPED YEL 10, Rx, Sterile; 00597603110 Articular Surface AC ART SURF 34/STRIPED YEL 10, Rx, Sterile; Used in total knee arthroplasty and indicated for patients with severe pain. "," all codes",".","192,355 all devices","Zimmer continuing investigation and monitoring of the NexGen Cruciate Retaining (CR) Complete Knee System found continued high rates of components used in combinations that are not approved (micro with standard) were implanted. This included the usage of CR Micro Femurs, CR Micro Articular Surface, CR Micro Patellae, CR Micro instruments and provisionals combined with standard components. Although the occurrence has been reduced since the March, 2012 recall, which reiterated proper combination labeling, it has not been eliminated and therefore Zimmer is initiating a recall to remove the affected devices and prevent this issue from recurring in all regions but Japan. ",6/7/2013,"06/07/2013",8/28/2013,"08/28/2013"
"Devices",65413,"Ongoing","Zimmer, Inc.","Warsaw","IN","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Worldwide Distribution-USA (nationwide) and the country of Japan.","Z-2036-2013","Class II","00598706201 Provisional CRA FEM PROV/CUT GDE SZ BML, Rx, Sterile; 00598706202 Provisional CRA FEM PROV/CUT GDE SZ BMR, Rx, Sterile; Used in total knee arthroplasty and indicated for patients with severe pain. "," all codes",".","192,355 all devices","Zimmer continuing investigation and monitoring of the NexGen Cruciate Retaining (CR) Complete Knee System found continued high rates of components used in combinations that are not approved (micro with standard) were implanted. This included the usage of CR Micro Femurs, CR Micro Articular Surface, CR Micro Patellae, CR Micro instruments and provisionals combined with standard components. Although the occurrence has been reduced since the March, 2012 recall, which reiterated proper combination labeling, it has not been eliminated and therefore Zimmer is initiating a recall to remove the affected devices and prevent this issue from recurring in all regions but Japan. ",6/7/2013,"06/07/2013",8/28/2013,"08/28/2013"
"Devices",65413,"Ongoing","Zimmer, Inc.","Warsaw","IN","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Worldwide Distribution-USA (nationwide) and the country of Japan.","Z-2004-2013","Class II","00597601201 Femur CRA PRECOAT FEM COMP SIZE B/L Rx, Sterile; 00597601202 Femur CRA PRECOAT FEM COMP SIZE B/R Rx, Sterile; Used in total knee arthroplasty and indicated for patients with severe pain. "," all codes",".","192,355 all devices","Zimmer continuing investigation and monitoring of the NexGen Cruciate Retaining (CR) Complete Knee System found continued high rates of components used in combinations that are not approved (micro with standard) were implanted. This included the usage of CR Micro Femurs, CR Micro Articular Surface, CR Micro Patellae, CR Micro instruments and provisionals combined with standard components. Although the occurrence has been reduced since the March, 2012 recall, which reiterated proper combination labeling, it has not been eliminated and therefore Zimmer is initiating a recall to remove the affected devices and prevent this issue from recurring in all regions but Japan. ",6/7/2013,"06/07/2013",8/28/2013,"08/28/2013"
"Devices",65413,"Ongoing","Zimmer, Inc.","Warsaw","IN","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Worldwide Distribution-USA (nationwide) and the country of Japan.","Z-2038-2013","Class II","00597106126 Provisional MIC POROUS PAT PROV 26MMX10MM, Rx, Sterile; 00597106129 Provisional MIC POROUS PAT PROV 29MMX10MM, Rx, Sterile; 00597106132 Provisional MIC POROUS PAT PROV 32MMX10MM, Rx, Sterile; 00597106135 Provisional MIC POROUS PAT PROV 35MMX10MM, Rx, Sterile; Used in total knee arthroplasty and indicated for patients with severe pain. "," all codes",".","192,355 all devices","Zimmer continuing investigation and monitoring of the NexGen Cruciate Retaining (CR) Complete Knee System found continued high rates of components used in combinations that are not approved (micro with standard) were implanted. This included the usage of CR Micro Femurs, CR Micro Articular Surface, CR Micro Patellae, CR Micro instruments and provisionals combined with standard components. Although the occurrence has been reduced since the March, 2012 recall, which reiterated proper combination labeling, it has not been eliminated and therefore Zimmer is initiating a recall to remove the affected devices and prevent this issue from recurring in all regions but Japan. ",6/7/2013,"06/07/2013",8/28/2013,"08/28/2013"
"Devices",65413,"Ongoing","Zimmer, Inc.","Warsaw","IN","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Worldwide Distribution-USA (nationwide) and the country of Japan.","Z-2042-2013","Class II","00597102010 Provisional CR ART SURF PROV 12/PURPLE 10, Rx, Sterile; 00597102012 Provisional CR ART SURF PROV 12/PURPLE 12, Rx, Sterile; 00597102014 Provisional CR ART SURF PROV 12/PURPLE 14, Rx, Sterile; 00597102017 Provisional CR ART SURF PROV 12/PURPLE 17, Rx, Sterile; 00597102020 Provisional CR ART SURF PROV 12/PURPLE 20, Rx, Sterile; 00597102023 Provisional CR ART SURF PROV 12/PURPLE 23, Rx, Sterile; Used in total knee arthroplasty and indicated for patients with severe pain. "," all codes",".","192,355 all devices","Zimmer continuing investigation and monitoring of the NexGen Cruciate Retaining (CR) Complete Knee System found continued high rates of components used in combinations that are not approved (micro with standard) were implanted. This included the usage of CR Micro Femurs, CR Micro Articular Surface, CR Micro Patellae, CR Micro instruments and provisionals combined with standard components. Although the occurrence has been reduced since the March, 2012 recall, which reiterated proper combination labeling, it has not been eliminated and therefore Zimmer is initiating a recall to remove the affected devices and prevent this issue from recurring in all regions but Japan. ",6/7/2013,"06/07/2013",8/28/2013,"08/28/2013"
"Devices",65413,"Ongoing","Zimmer, Inc.","Warsaw","IN","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Worldwide Distribution-USA (nationwide) and the country of Japan.","Z-2033-2013","Class II","00597604110 Articular Surface AC ART SURF 56/STRIPED GRN 10, Rx, Sterile; 00597604112 Articular Surface AC ART SURF 56/STRIPED GRN 12, Rx, Sterile; 00597604114 Articular Surface AC ART SURF 56/STRIPED GRN 14, Rx, Sterile; 00597604117 Articular Surface AC ART SURF 56/STRIPED GRN 17, Rx, Sterile; 00597604120 Articular Surface AC ART SURF 56/STRIPED GRN 20, Rx, Sterile; 00597604123 Articular Surface AC ART SURF 56/STRIPED GRN 23, Rx, Sterile; Used in total knee arthroplasty and indicated for patients with severe pain. "," all codes",".","192,355 all devices","Zimmer continuing investigation and monitoring of the NexGen Cruciate Retaining (CR) Complete Knee System found continued high rates of components used in combinations that are not approved (micro with standard) were implanted. This included the usage of CR Micro Femurs, CR Micro Articular Surface, CR Micro Patellae, CR Micro instruments and provisionals combined with standard components. Although the occurrence has been reduced since the March, 2012 recall, which reiterated proper combination labeling, it has not been eliminated and therefore Zimmer is initiating a recall to remove the affected devices and prevent this issue from recurring in all regions but Japan. ",6/7/2013,"06/07/2013",8/28/2013,"08/28/2013"
"Devices",65413,"Ongoing","Zimmer, Inc.","Warsaw","IN","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Worldwide Distribution-USA (nationwide) and the country of Japan.","Z-2008-2013","Class II","65595201201 Femur CR-FLEX POR HATCP FEM B-L Rx, Sterile; 65595201202 Femur CR-FLEX POR HATCP FEM B-R Rx, Sterile; Used in total knee arthroplasty and indicated for patients with severe pain."," all codes",".","192,355 all devices","Zimmer continuing investigation and monitoring of the NexGen Cruciate Retaining (CR) Complete Knee System found continued high rates of components used in combinations that are not approved (micro with standard) were implanted. This included the usage of CR Micro Femurs, CR Micro Articular Surface, CR Micro Patellae, CR Micro instruments and provisionals combined with standard components. Although the occurrence has been reduced since the March, 2012 recall, which reiterated proper combination labeling, it has not been eliminated and therefore Zimmer is initiating a recall to remove the affected devices and prevent this issue from recurring in all regions but Japan. ",6/7/2013,"06/07/2013",8/28/2013,"08/28/2013"
"Biologics",65414,"Terminated","OneBlood, Inc.","Hialeah","FL","US","Voluntary: Firm Initiated","Letter","Florida","B-2130-13","Class II","Red Blood Cells (Apheresis)","W036813029167; ",,"1","Blood products, collected from a donor whose suitability to donate was not adequately determined, were distributed.",5/30/2013,"05/30/2013",9/4/2013,"09/04/2013"
"Biologics",65414,"Terminated","OneBlood, Inc.","Hialeah","FL","US","Voluntary: Firm Initiated","Letter","Florida","B-2131-13","Class II","Red Blood Cells (Apheresis) Leukocytes Reduced","W036813029167; ",,"1","Blood products, collected from a donor whose suitability to donate was not adequately determined, were distributed.",5/30/2013,"05/30/2013",9/4/2013,"09/04/2013"
"Biologics",65415,"Terminated","OneBlood, Inc.","Hialeah","FL","US","Voluntary: Firm Initiated","Letter","Florida","B-2208-13","Class II","Fresh Frozen Plasma","W036810255463; ",".","1","Blood products, collected from a donor for whom donor suitability was not adequately determined, were distributed.",5/28/2013,"05/28/2013",9/18/2013,"09/18/2013"
"Biologics",65415,"Terminated","OneBlood, Inc.","Hialeah","FL","US","Voluntary: Firm Initiated","Letter","Florida","B-2209-13","Class II","Red Blood Cells","W036810255463; ",".","1","Blood products, collected from a donor for whom donor suitability was not adequately determined, were distributed.",5/28/2013,"05/28/2013",9/18/2013,"09/18/2013"
"Biologics",65416,"Terminated","South Texas Blood & Tissue Center","San Antonio","TX","US","Voluntary: Firm Initiated","Telephone","Texas","B-2210-13","Class II","Platelets Pheresis Leukocytes Reduced","W140913280381 Part 1; W140913280381 Part 2; W140913280381 Part 3; ",".","3","Blood products, which did not meet the acceptable product specifications, were distributed.",3/2/2013,"03/02/2013",9/18/2013,"09/18/2013"
"Devices",65417,"Ongoing","Maquet Cardiovascular Us Sales, Llc","Wayne","NJ","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution - US Distribution including the states of Delaware, Illinois, Minnesota , New York., Ohio and Pennsylvania and the countries of Germany, Turkey and France.","Z-1572-2013","Class II","MAQUET GETINGE GROUP Arterial Cannula OD Used to introduce blood and sterile solutions into the systemic circulation during pediatric extracorporeal circulation procedures. ","Catalogue Number:Part Number: Lot Number are as follows: (1) 161410 (10 FR.):701022682:92056588 (2) 163610 (10 Fr):70102597:92059789 (3) 163608 (8 Fr.):70102.2681:92065640 (4) 163606 (6 Fr.):70102.2680:92063566",,"100 units (60 Domestic; 40 International)","The specified part numbers and lot numbers of Maquet Pediatric Arterial Cannula Packs may contain an incorrectly sized connector. ",5/14/2013,"05/14/2013",7/3/2013,"07/03/2013"
"Devices",65418,"Ongoing","Siemens Medical Solutions USA, Inc","Martinez","CA","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution: USA Nationwide and countries of: Algeria, Angola, Argentina, Austria, Australia, Bahamas, Belgium, Bosnia Herzeg, Bulgaria, Brazil, Canada, Chile, Colombia, Croatia, Ecuador, Egypt, El Salvador, France, Germany, Greece, Hungary, India, Indonesia, Italy, Iran, Iraq, Ireland, Japan, Jordan, Kenya, DPR of Korea, Kosovo, Kuwait, Lebanon, Lithuania, Malaysia, Mexico, Nepal, Netherlands, New Zealand, Norway, Pakistan, Palestinian Ter, Peru, Philippines, P.R. China, Poland, Portugal, Romania, Saudi Arabia, Slovakia, Spain, Sri Lanka, South Africa, Sweden, Switzerlan, Taiwan, Thailand, Trinidad Tobago,Turkey, United Kingdom, Venezula, Vietnam, Rep of Yemen, and Zambia.","Z-1663-2013","Class II","Siemens MEVATRON series, PRIMART (limited release)PRIMUS and/or ONCOR or ARTIST Linac Systems with BEAMVIEW capability. The intended use of the SIEMENS branded MEVATRON'', ARTISTE'', ONCOR'' and PRIMUS'' family of linear accelerator systems is to deliver X-ray photon and electron radiation for the therapeutic treatment of cancer.","All customers who use the BEAMVIEW for position verification imaging on Siemens MEVATRON series, PRIMART (limited release) PRIMUS and/or ONCOR or ARTIST Linac Systems.",".","1956 customers","The information regarding the FILM Mode calibration may have been considered difficult to interpret when translated. SIEMENS HEALTHCARE CR / RADIATION ONCOLOGY had become aware that this issue may have resulted in mistreatment of patients.",5/29/2013,"05/29/2013",7/10/2013,"07/10/2013"
"Food",65419,"Ongoing","Palmer Candy Co","Sioux City","IA","US","Voluntary: Firm Initiated","Letter","Distribution made to TN, ND, NE, IL, SD and MO. No foreign or military/government distribution made.","F-1637-2013","Class I","Eagle Premium, Snack Shoppe, Pistachios, in-shell pistachios, packaged in 2-oz (UPC 4262500705) and 5.25-oz (UPC 42625000604) bags. Distributed by: Genco Marketing, Omaha, NE.","2-oz packages - Best Before: 10/16/13; 10/17/13; 10/18/13; 10/30/13; 11/14/13; 12/15/13; 02/20/14; 03/04/14; 03/18/14; 03/26/14; 04/04/14; 04/16/14; 04/23/14 and 05/16/14 5.25-oz packages - Best Before: 10/16/13; 04/14/14 and 04/24/14",".","112/12/5.25-oz bag/cases and 4,264/8/2.0-oz bag/cases","The product may be contaminated with Salmonella.",6/11/2013,"06/11/2013",7/17/2013,"07/17/2013"
"Devices",65420,"Ongoing","Codman & Shurtleff, Inc.","Raynham","MA","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution-USA (nationwide) including the states of FL, NC, NJ, and TX, and the countries of Austria, Australia, Belgium, China, Denmark, Spain, Great Britain, Germany, Italy, Ireland, Luxemburg, Russia, Saudi Arabia, and Turkey.","Z-1691-2013","Class I","MedStream Programmable Infusion Pump , Implantable for the intrathecal delivery of Baclofen or Morphine Product Code: 91-4201US (40ml pump) 91-4201 (40ml pump) Intended for the intrathecal delivery of Baclofen or Morphine. ","All serial numbers",".","5 US and and 360 OUS","Miscalibrated Fill Level Sensor may affect dosing level",6/7/2013,"06/07/2013",7/24/2013,"07/24/2013"
"Devices",65420,"Ongoing","Codman & Shurtleff, Inc.","Raynham","MA","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution-USA (nationwide) including the states of FL, NC, NJ, and TX, and the countries of Austria, Australia, Belgium, China, Denmark, Spain, Great Britain, Germany, Italy, Ireland, Luxemburg, Russia, Saudi Arabia, and Turkey.","Z-1690-2013","Class I","MedStream Programmable Infusion Pump- Implantable for the intrathecal delivery of Baclofen or Morphine Product Code:91-4200 (20ml pump) US 91-4200. Intended for the intrathecal delivery of Baclofen or Morphine.","All serial numbers",".","2 units US and 735 OUS","Miscalibrated Fill Level Sensor may affect dosing level",6/7/2013,"06/07/2013",7/24/2013,"07/24/2013"
"Drugs",65422,"Ongoing","Novartis Consumer Health","Lincoln","NE","US","Voluntary: Firm Initiated","Letter","Nationwide, Puerto Rico, Brazil and Panama","D-844-2013","Class II","Excedrin Migraine (Acetaminophen 250 mg, Aspirin (NSAID) 250 mg and Caffeine 65 mg), a) 2-count tablets packaged in pouches, Distributed by Novartis Consumer Health, Inc., Parsippany, NJ, NDC 0067 203 702 Foreign packaging: b) Excedrin Migrana (Acetaminophen 250 mg, Aspirin 250 mg and 65 mg Caffeine) 2-ct pouches. The foreign packaging do not have NDC numbers","Lot # a) 10116809, Exp 5/13 Foreign: Lot #s b) 10115644 Exp 5/13; 10118226 Exp 5/13; 10118227 Exp 6/13; 10118228 Exp 6/13; 10121956 Exp 8/13 and 10121957 Exp 8/13",".","10,624,000 pouches","Defective container: products are packaged in pouches which may not have been fully sealed",6/6/2013,"06/06/2013",8/14/2013,"08/14/2013"
"Drugs",65422,"Ongoing","Novartis Consumer Health","Lincoln","NE","US","Voluntary: Firm Initiated","Letter","Nationwide, Puerto Rico, Brazil and Panama","D-845-2013","Class II","No Doz, Max Strength (200 mg caffeine) caplets, 2-count caplets per pouch, Distributed by Novartis Consumer Health, Inc., Parsippany, NJ, NDC 0067 2070 02","Lot #s 10110263, Exp 2/14; 10114706, Exp 4/14; 10118209, Exp 5/14; 10120253, Exp 7/14; 10123520, Exp 8/14; 10095199, Exp 7/13; 10102536, 11/2013, 10103950, Exp 12/13",".","4,422,000 pouches","Defective container: products are packaged in pouches which may not have been fully sealed",6/6/2013,"06/06/2013",8/14/2013,"08/14/2013"
"Drugs",65422,"Ongoing","Novartis Consumer Health","Lincoln","NE","US","Voluntary: Firm Initiated","Letter","Nationwide, Puerto Rico, Brazil and Panama","D-843-2013","Class II","Excedrin Extra Strength (Acetaminophen 250 mg, Aspirin (NSAID) 250 mg and Caffeine 65 mg), a) 2-ct tablets in pouches b) boxes of 50/2-ct packages, Distributed by Novartis Consumer Health, Inc., Parsippany, NJ, NDC 0067 2030 02 Foreign packaging: c) Parsel Forte and d) Cibalenaa (250 mg Acetaminophen, 250 mg Aspirin, 65 mg Caffeine), boxes of 48/4-ct pouches Foreign packaging do not have NDC numbers.","Lot #s a) 10120190, Exp 6/13 and 10121628, Exp 7/13; Lot #s b) 10115658, Exp 5/13; 10116807, Exp 5/13; 10121630, Exp 7/13 and 10125253, Exp 9/13 Foreign Lot #s c) 10120192, Exp 7/13; d)10120272, Exp 7/13, 10121528 Exp 7/13 and 10121958 Exp 8/13 ",".","a) 4,178,000 pouches; b) 101,300 boxes and c) & d) 38,235 pouches and boxes (combined)","Defective container: products are packaged in pouches which may not have been fully sealed",6/6/2013,"06/06/2013",8/14/2013,"08/14/2013"
"Drugs",65422,"Ongoing","Novartis Consumer Health","Lincoln","NE","US","Voluntary: Firm Initiated","Letter","Nationwide, Puerto Rico, Brazil and Panama","D-846-2013","Class II","Parsel Plus (reference US product: Excedrin Tension Headache) (Acetaminophen 500 mg and Caffeine 65 mg), packaged in 2-count pouches, Distributed by Novartis Consumer Health, Inc., USA and Novartis Consumer Health S.A., Brazil, for Novartis de Venezuela. The foreign packaging do not have NDC number This product was only distributed to Novartis Brazil by the recalling firm","Lot # 10121996, Exp 7/13",".","472,000 pouches","Defective container: products are packaged in pouches which may not have been fully sealed",6/6/2013,"06/06/2013",8/14/2013,"08/14/2013"
"Devices",65423,"Ongoing","BRAEMAR, INC.","Eagan","MN","US","Voluntary: Firm Initiated","Telephone","Nationwide Distribution including FL, IL, MD, MN, NY, OH, PA, SC, TN, and TX.","Z-1645-2013","Class II","Lithium Thionyl non-rechargeable disposable battery pack P/N 350-0294-00 used with ER920 Wireless Series Arrhythmia Event Recorder. Non-rechargeable disposable battery pack.","n/a",".","10,785 packs","Braemar Inc., became aware of a battery related incident that occurred with an Able battery pack being used in a Braemar ER920W wireless event monitor. The event did not result in any patient related injury or present any clinical impact.",5/2/2011,"05/02/2011",7/10/2013,"07/10/2013"
"Biologics",65424,"Terminated","OneBlood / dba CBCF","Lauderhill","FL","US","Voluntary: Firm Initiated","Telephone","Florida","B-2211-13","Class II","Platelets Pooled Leukocytes Reduced","W036812848389; ",".","1","Blood products, collected from a donor for whom donor suitability was not adequately determined, were distributed. ",6/4/2013,"06/04/2013",9/18/2013,"09/18/2013"
"Biologics",65424,"Terminated","OneBlood / dba CBCF","Lauderhill","FL","US","Voluntary: Firm Initiated","Telephone","Florida","B-2212-13","Class II","Red Blood Cells Leukocytes Reduced","W036812618065; ",".","1","Blood products, collected from a donor for whom donor suitability was not adequately determined, were distributed. ",6/4/2013,"06/04/2013",9/18/2013,"09/18/2013"
"Biologics",65424,"Terminated","OneBlood / dba CBCF","Lauderhill","FL","US","Voluntary: Firm Initiated","Telephone","Florida","B-2213-13","Class III","Blood and Blood Products for Reprocessing","W036812618065; ",".","1","Blood products, collected from a donor for whom donor suitability was not adequately determined, were distributed. ",6/4/2013,"06/04/2013",9/18/2013,"09/18/2013"
"Biologics",65425,"Terminated","OneBlood / dba CBCF","Lauderhill","FL","US","Voluntary: Firm Initiated","Letter","Florida","B-2215-13","Class II","Platelets Pooled Leukocytes Reduced","W036812859838; ",".","1","Blood products, collected from a donor for whom donor suitability was not adequately determined, were distributed. ",6/3/2013,"06/03/2013",9/18/2013,"09/18/2013"
"Biologics",65425,"Terminated","OneBlood / dba CBCF","Lauderhill","FL","US","Voluntary: Firm Initiated","Letter","Florida","B-2214-13","Class II","Red Blood Cells Leukocytes Reduced","W036812543028; ",".","1","Blood products, collected from a donor for whom donor suitability was not adequately determined, were distributed. ",6/3/2013,"06/03/2013",9/18/2013,"09/18/2013"
"Biologics",65425,"Terminated","OneBlood / dba CBCF","Lauderhill","FL","US","Voluntary: Firm Initiated","Letter","Florida","B-2216-13","Class II","Fresh Frozen Plasma","W036812543028; ",".","1","Blood products, collected from a donor for whom donor suitability was not adequately determined, were distributed. ",6/3/2013,"06/03/2013",9/18/2013,"09/18/2013"
"Food",65426,"Ongoing","Butterfly Bakery Inc.","Clifton","NJ","US","Voluntary: Firm Initiated","Letter","NY","F-1586-2013","Class I","Butterfly Bakery Harvest Berry Muffins (four muffins per package) Net. Wt. 14.5 OZ (410 g) UPC 6 43482 60014 8 Manufactured by: Butterfly Bakery Inc.200 Clifton Boulevard, Clifton, NJ 07013 T: 973.815.1501 Packaged in a plastic clam shell.","UPC 6 43482 60014 8",".","42 cases","Whole grain harvest berry muffins may contain undeclared walnuts.",6/5/2013,"06/05/2013",7/10/2013,"07/10/2013"
"Food",65427,"Ongoing","Kenton Burr","Trumansburg","NY","US","Voluntary: Firm Initiated","Telephone","New York State (Fingerlakes region)","F-1716-2013","Class III","KENTON'S CHEESE CO. Bianco A soft Brie-Style cheese Aged at least 60 days, Net Wt. 8 oz wheel. Distributed by Kenton's Cheese Company 5939 Burr Rd. Trumansburg, NY 14886.","Batch: 13064",".","200 wheels","Kenton's Cheese Co. is recalling Bianco A Soft Brie-Style Cheese due to E.coli contamination. Consumers who have purchased Bianco-Brie from Kenton's Cheese Co. between May 9, 2013 and May 19, 2013 listed with Batch number 13064, are urged to return the product to Kenton's Cheese Co. 5939 Burr Road Trumansburg, NY 14886. Questions may be directed to Kenton Burr (607) 592-0746 or via e-mail kenton@kentonscheeseco.com. A full refund will be provided by Kenton's Cheese Co.",6/5/2013,"06/05/2013",7/24/2013,"07/24/2013"
"Drugs",65428,"Ongoing","Boehringer Ingelheim Roxane Inc","Columbus","OH","US","Voluntary: Firm Initiated","Letter","Nationwide","D-1057-2013","Class III","SPIRIVA HandiHaler (Tiotropium Bromide Inhalation Powder) Capsules 18 mcg per dose, Rx only, a) 10 count blister (NDC 0597-0075-27), b) 30 count blister (NDC 0597-0075-41), c) 90 count blister (NDC 0597-0075-47), d) 5 count blister physician sample (NDC 0597-0075-75), Manufactured by: Boehringer Ingelheim (BI) Pharma, GmbH & Co. KG, Ingelheim, Germany ","Lot Number/Exp. Date: 202477A/Sep-13, 202480A/Sep-13, 202556B/Sep-13, 202603A/Sep-13, 202784B/Sep-13, 202844A/Sep-13, 202951A/Sep-13, 203041A/Sep-13, 203042A,Sep-13, 203280A/Oct-13, 203281A/Oct-13, 203364A/Oct-13, 203440A,Oct-13, 203569B/Oct-13, 203588A/Oct-13, 203890B/Nov-13, 204094A/Nov-13, 203660A/Nov-13, 203690A/Nov-13, 203890A/Nov-13, 203980A/Nov-13, 203981B/Nov-13, 204356B/Dec-13, 204357A/Dec-13, 204821A/Dec-13, 204459A/Dec-13, 204552C/Dec-13, 204822A/Dec-13, 204944A/Jan-14, 204947A/Jan-14, 205015A/Jan-14, 205163A/Jan-14, 205364A/Jan-14, 205509A/Feb-14, 205737A/Feb-14, 205571A/Feb-14, 205572A/Feb-14, 205674A/Feb-14, 205682A/Feb-14, 205959A/Feb-14, 205987A/Feb-14, 206186B/Mar-14, 206311A/Mar-14, 206606A/Mar-14, 206944B/Apr-14, 207066A/Apr-14, 206609A/Apr-14, 206729A/Apr-14, 206899A/Apr-14, 206900A/ Apr-14, 207065B/Apr-14, 207191A/May-14, 207199A/May-14, 207352A/May-14, 207420A/May-14, 207577B/May-14, 207691A/May-14, 207692A/May-14, 207778A/May-14, 207818A/Jun-14, 301378A/Jul-14, 301476B/Jul-14, 301699B/Jul-14, 301867A/Aug-14, 202530/Sep-13, 203195A/Oct-13, 203366C/Nov-13, 204067A/Nov-13, 204460B/Dec-13, 204551A/Dec-13, 205260A/Jan-14, 206064B/Mar-14, 206185A/Mar-14, 206939A/Apr-14, 207038A/May-14, 301699A/Jul-14, 202556A/Sep-13, 203569A/Oct-13, 203981A/Nov-13, 204674A/Dec-13, 205737B/Feb-14, 206944A/Apr-14, 207577A/May-14, 301476A/Jul-14 Physician Drug Samples: 203076A/Oct-13, 203891A/Nov-13, 204674B/Dec-13, 205867A/Feb-14, 206731A/Apr-14 ",,"15,385,232 capsules ","Presence of Foreign Substance: This recall is being conducted due to the potential for extrinsic foreign particles in the API used to manufacture SPIRIVA Handihaler",8/30/2013,"08/30/2013",9/25/2013,"09/25/2013"
"Devices",65430,"Ongoing","Medtronic MiniMed","Northridge","CA","US","Voluntary: Firm Initiated","Letter","Worldwide distribution: US (nationwide) distribution: Algeria, Argentina, Australia, Bahamas, Bahrain, Bermuda, Boliva, Bosnia and Herzegovina, Brazil, Canada, Chile, China, Columbia, Costa Rica, Croatia, Cyprus, Denmark, Dominican Republic, Ecuador, Egypt, El Salvador, Estonia, Finland, France, French Southern Territories, Germany, Great Britain, Greece, Guatemala, Hong Kong, India, Iraq, Ireland, Israel, Italy, Japan, Jordan, Kuwait, Latvia, Lebanon, Macedonia, Malaysia, Mexico, Morocco, Netherlands, Norway, New Zealand, Oman, Panama, Paraguay, Peru, Poland, Province of China, Taiwan, Qatar, Republic of Korea, Romania, Russia Federation, Saint Lucia, Saudi Arabia, Singapore, Slovakia, Slovenia, South Africa, Spain, Sweden, Switzerland, Syrian Arab Republic, Thailand, Trinidad and Tobago, Turkey, Ukraine, United Arab Emirates, Uruguay, andVenezuela.","Z-1668-2013","Class I","Medtronic MiniMed Paradigm Insulin Infusion Sets The Paradigm infusion sets are intended for use with Paradigm insulin infusion pumps. ","This field correction involves models: MMT-317, MMT-318, MMT-324, MMT-325, MMT-312S, MMT-312L, MMT-386, MMT-387, MMT-394, MMT-396, MMT-397, MMT-398, MMT-399, MMT-377, MMT-378, MMT-381, MMT-382, MMT-383, MMT-384, MMT-368, MMT-862, MMT-864, MMT-866, MMT-874, MMT-876, MMT-884, MMT-886, MMT-921, MMT-923, MMT-925, MMT-941, MMT-943, MMT-945, MMT-961, MMT-963, MMT-965, & MMT-975 Paradigm Infusion sets.",".","11,000,000 units","Medtronic is recalling the Medtronic MiniMed Paradigm Insulin Infusion sets because of a potential safety issue that can occur if insulin or other fluids come in contact with the inside of Medtronic Paradigm infusion sets. Under certain conditions, the infusion set may malfunction and deliver an incorrect volume of insulin",6/7/2013,"06/07/2013",7/17/2013,"07/17/2013"
"Devices",65431,"Ongoing","Becton Dickinson & Co.","Sparks","MD","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution - USA Nationwide and in the countries of: Japan, Singapore, Hong Kong, China, Australia, Europe, and Chile.","Z-1662-2013","Class III","BD MAX Instrument, catalog #441916 Product Usage: The BD MAX System, used in conjunction with the appropriate extraction kits and reagents is capable of automated amplification and detection of target nucleic acid sequences for use in clinical, industrial, and research settings. ","Serial Numbers: CT0173 to CT0249, CT0253 to CT0260, CT0262, CT0263, CT0265, CT0269, and CT0272",".","71 instruments","Electrical power module installed on some in vitro diagnostic instruments does not meet industry standards as labeled.",5/31/2013,"05/31/2013",7/10/2013,"07/10/2013"
"Devices",65433,"Ongoing","Medtronic Inc. Cardiac Rhythm Disease Management","Saint Paul","MN","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution - USA including CA, FL, GA, KY, LA, LMN, MO, NE, NY, OK, PA, TN, TX, WI, and PR and Internationally to Australia, Austria, Belgium, Brazil, Bulgaria, Canada, Chile, China, Colombia, Denmark, Ecuador, Egypt, Finland, France, Germany, Hungary, Ireland, Italy, Japan, Latvia, Lebanon, Netherlands, Norway, Poland, Singapore, South Africa, Spain, Sweden, Switzerland, Taiwan, Tunisia ,United Arab Emirates, United Kingdom, Uruguay , and Yemen,","Z-1607-2013","Class II","Medtronic, Consulta CRT-P, Model C4TR01, C3TR01 (not approved for US), and Syncra CRT-P, Model C2TR01, Sterile EO. Dual chamber and atrial tracking modes are indicated for patients who may benefit from maintenance of AV synchrony. ","ATTACHMENT A: Affected SN List Lot Serial No PZX624804S PZX625573S PZX626117S PZX626118S PZX626136S PZX626137S PZX626138S PZX626139S PZX626140S PZX626141S PZX626142S PZX626143S PZX626144S PZX626145S PZX626146S PZX626147S PZX626148S PZX626149S PZX626150S PZX626151S PZX626152S PZX626153S PZX626154S PZX626155S PZX626156S PZX626157S PZX626158S PZX626159S PZX626160S PZX626161S PZX626162S PZX626163S PZX626164S PZX626165S PZX626166S PZX626167S PZX626168S PZX626169S PZX626170S PZX626171S PZX626172S PZX626173S PZX626174S PZX626175S PZX626176S PZX626177S PZX626178S PZX626179S PZX626180S PZX626181S PZX626182S PZX626183S PZX626184S PZX626185S PZX626186S PZX626187S PZX626188S PZX626189S PZX626190S PZX626191S PZX626192S PZX626193S PZX626194S PZX626195S PZX626196S PZX626197S PZX626198S PZX626199S PZX626200S PZX626201S PZX626202S PZX626203S PZX626204S PZX626205S PZX626206S PZX626207S PZX626208S PZX626209S PZX626210S PZX626211S PZX626212S PZX626213S PZX626214S PZX626215S PZX626216S PZX626217S PZX626218S PZX626219S PZX626220S PZX626221S PZX626222S PZX626223S PZX626224S PZX626225S PZX626226S PZX626227S PZX626228S PZX626229S PZX626230S PZX626231S PZX626232S PZX626233S PZX626234S PZX626235S PZX626236S PZX626237S PZX626238S PZX626239S PZX626240S PZX626241S PZX626242S PZX626243S PZX626244S PZX626245S PZX626246S PZX626247S PZX626248S PZX626249S PZX626250S PZX626251S PZX626252S PZX626253S PZX626254S PZX626255S PZX626256S PZX626257S PZX626258S PZX626259S PZX626260S PZX626261S PZX626262S PZX626263S PZX626264S PZX626265S PZX626266S PZX626267S PZX626268S PZX626269S PZX626270S PZX626271S PZX626272S PZX626273S PZX626274S PZX626275S PZX626276S PZX626277S PZX626278S PZX626279S PZX626280S PZX626281S PZX626282S PZX626283S PZX626285S PZX626286S PZX626287S PZX626288S PZX626289S PZX626290S PZX626291S PZX626292S PZX626294S PZX626296S PZX626297S PZX626298S PZX626299S PZX626300S PZX626301S PZX626302S PZX626303S PZX626304S PZX626305S PZX626306S PZX626307S PZX626308S PZX626309S PZX626310S PZX626311S PZX626312S PZX626313S PZX626318S PZX626319S PZX626320",,"1912 (159 USA & 1137 OUS)","Medtronic recently identified an issue with a subset of Consulta CRT-P and Syncra CRT-P devices during production. As of May 30, 2013, there have been no reported or confirmed device failures. However, because of the potential for malfunction, Medtronic is requiring the return of non-implanted devices manufactured between April 1 and May 13, 2013 for re-inspection. The issue is unique to specific Consulta and Syncra CRT-P devices and no other Medtronic device models are affected. This issue was identified as a result of an internal investigation that indicated a recent trend of increasing manufacturing rejects related to the weld of a connector bracket. An out-of-specification weld could result in a loss of device hermeticity and compromised device functionality.",6/7/2013,"06/07/2013",7/3/2013,"07/03/2013"
"Drugs",65434,"Ongoing","Hill Dermaceuticals, Inc.","Sanford","FL","US","Voluntary: Firm Initiated","Letter","Nationwide and Puerto Rico","D-610-2013","Class III","Derma-Smoothe/FS (fluocinolone acetonide) Topical Oil (SCALP OIL), 0.01 %, 118.28 mL (4 Fl. oz.) bottle, Rx only, Manufactured and Distributed by: Hill Dermaceuticals, Inc. SANFORD, FLORIDA 32773; NDC 28105-149-04.","Lot #: H110940, Exp 08/13",,"8,808 bottles","Subpotent Drug: the active ingredient, fluocinolone acetonide, was found to be subpotent during the firm's routine testing.",5/7/2013,"05/07/2013",7/3/2013,"07/03/2013"
"Biologics",65436,"Terminated","Northern Illinois Blood Bank dba Rock River Valley BC","Rockford","IL","US","Voluntary: Firm Initiated","FAX","Illinois","B-2218-13","Class II","Red Blood Cells (Apheresis) Leukocytes Reduced","W044413200831; ",".","1","Blood products, collected from a donor who had traveled to a malarial endemic area, were distributed.",4/26/2013,"04/26/2013",9/18/2013,"09/18/2013"
"Biologics",65436,"Terminated","Northern Illinois Blood Bank dba Rock River Valley BC","Rockford","IL","US","Voluntary: Firm Initiated","FAX","Illinois","B-2217-13","Class II","Platelets Pheresis Leukocytes Reduced","W044413200831; ",".","1","Blood products, collected from a donor who had traveled to a malarial endemic area, were distributed.",4/26/2013,"04/26/2013",9/18/2013,"09/18/2013"
"Biologics",65437,"Terminated","LifeNet Health","Virginia Beach","VA","US","Voluntary: Firm Initiated","Letter","Massachusetts","B-2097-13","Class II","Cardiac Tissue, Non-valved","083696HV02",".","1 allograft","Cardiac pulmonary patch, recovered from a donor and not tested using appropriate FDA-licensed, approved, or cleared donor screening tests, in accordance with the manufacturer's instructions, to adequately and appropriately reduce the risk of transmission of relevant communicable disease agents or diseases, was distributed.",5/10/2013,"05/10/2013",8/28/2013,"08/28/2013"
"Devices",65438,"Ongoing","Hitachi Medical Systems America Inc","Twinsburg","OH","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution - US Nationwide including the states of AZ, CA, CO, DE, FL, IL, IN, KS, KY, MD, NC, ND, NY, OH, OR, PA, TX, VA, WA, and WI. One (1) system unit was also distributed to Mexico.","Z-1559-2013","Class II","Echelon, Echelon Oval and Oasis MR imaging device systems; one unit per box. The Echelon, Echelon Oval and Oasis MR systems are imaging devices, and are intended to provide the physician with physiological and clinical information, obtained non-invasively and without the use of ionizing radiation. The MR systems produce transverse, coronal, sagittal, oblique, and curved cross-sectional images that display the internal structure of the head, body, or extremities. ","The following serial numbers are associated with this recall: Echelon - V061, V062, and V065 Oasis - M009, M017, M067, M071, M084, M106-M108, M110-M141 inclusive, and M952 Echelon Oval - Y001-Y005 inclusive",,"45 system units","Hitachi discovered a software error that can occur when simultaneously scanning a patient while processing images previously acquired from a different patient. The software error can occur randomly. The error causes an image in the processed dataset to have the same unique identifier (UID) as in the scanning dataset. The processed image is stored in the place of the original image, which is lost. If the two datasets have similar anatomy, position, and orientation, the error could potentially lead to a misdiagnosis.",1/31/2013,"01/31/2013",6/26/2013,"06/26/2013"
"Devices",65439,"Ongoing","Angiodynamics, INC","Manchester","GA","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution, including the US, Austria, China, Italy, Russia and the UK.","Z-1675-2013","Class II","AngioDynamics RITA Main Cable, 9 Pin to 14 Pin, REF 700-101892. RITA Main Cables are indicated for use with the RITA RF Generators and RITA electrosurgical devices.","Catalog #700-101892, Lot number: 30.12",".","13 units","The RITA Main Cable product contains the incorrect Instructions for Use.",6/11/2013,"06/11/2013",7/17/2013,"07/17/2013"
"Devices",65440,"Ongoing","Beckman Coulter Inc.","Brea","CA","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution, including Nationwide (US) and the countries of China, Italy, Japan, Canada, Turkey, United Kingdom, Singapore, Israel, and the Netherlands.","Z-1834-2013","Class II","AU5800 Clinical Chemistry Analyzer with Automation Ready Connection (All Software Versions), Model Numbers AU5811, AU5821, AU5831 and AU5841. This system is for in vitro diagnostic use only. ","Model Numbers: AU5811-01, AU5821-01, AU5831-01, AU5841-01, AU5811-02, AU5821-02, AU5831-02, AU5841-02, AU5811-03, AU5821-03, AU5831-03, AU5841-03, AU5811-04, AU5821-04, AU5831-04, AU5841-04, AU5811-06, AU5821-06, AU5831-06, AU5841-06 Part Numbers: A94906, A94911, A94916, A91921 A94907, A94912, A94917, A94922 A94908, A94913, A94918, A94923 A94909, A94914, A91949, A94924 A94910, A94915, A94920, A94925 Serial Numbers: All",,"76 units","The recall was initiated because Beckman Coulter has identified a software error on AU5800 analyzers with the Automation Ready (AR) Sampler Kit. This software error results in the failure of the concentrated wash solution pump to stop, creating an overflow or leak on each analyzer unit.",6/3/2013,"06/03/2013",8/7/2013,"08/07/2013"
"Drugs",65441,"Ongoing","Bethel Nutritional Consulting, Inc","New York","NY","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Nationwide. Product was also available for sale via internet","D-921-2013","Class I","Bethel 30 capsules, packaged in 30 count bottles, Distributed by BETHEL INC. New York, New York","Lot #: 120514, EXP: 12/2014",,"18,678 bottles ","Marketed Without An Approved NDA/ANDA: FDA analysis found this product contained undeclared sibutramine and phenolphthalein, two active ingredients that were once marketed in the U.S. but removed due to safety reasons, making this product an unapproved new drug. ",6/11/2013,"06/11/2013",9/4/2013,"09/04/2013"
"Devices",65444,"Ongoing","SpineFrontier, Inc.","Beverly","MA","US","Voluntary: Firm Initiated","E-Mail","Nationwide Distribution including Texas, Ohio, and Missouri.","Z-1927-2013","Class II","Invue Split Driver, Assembly with Handle, Model SI70006 Rev G. Used in conjunction with the Invue Anterior Cervical Plate System under 501(k) clearance number K121060. The Invue Driver is an instrument consisting of a Radel handle, a shaft and hexalobe-like tip with a 4.0mm split, which allows the driver to collapse to fit into a screw and expand to retain the screw.","Lot/Serial Numbers: 027104, 027105",".","12 devices","Device design. ",5/10/2013,"05/10/2013",8/14/2013,"08/14/2013"
"Drugs",65445,"Ongoing","West-Ward Pharmaceutical Corp.","Eatontown","NJ","US","Voluntary: Firm Initiated","Letter","Nationwide","D-824-2013","Class II","West-ward Belladonna Alkaloids with Phenobarbital Tablets, a) 1000-count bottle (NDC 0143-1140-10), b) 5000-count bottle (NDC 0143-1140-51), Rx only, Manufactured by West-ward Pharmacuetical Corp., Eatontown, N.J., 07724 ","Lot # 69098A, 69098B, 69100A; Exp 8/15 ",,"14,503 bottles","Presence of Foreign Substance: Uncharacteristic blacks spots were found in tablets.",5/16/2013,"05/16/2013",7/31/2013,"07/31/2013"
"Drugs",65445,"Ongoing","West-Ward Pharmaceutical Corp.","Eatontown","NJ","US","Voluntary: Firm Initiated","Letter","Nationwide","D-825-2013","Class II","West-ward Belladonna Alkaloids with Phenobarbital Tablets, a) 1000-count bottle (NDC 0143-1140-10),Rx only, Manufactured by West-ward Pharmacuetical Corp., Eatontown, N.J., 07724 ","Lot# 67331A, Exp 10/14 ",,"7,324 bottles","Cross contamination with other products: Belladonna Alkaloids with Phenobarbital Tablets contained a trace amount of Methocarbamol.",5/16/2013,"05/16/2013",7/31/2013,"07/31/2013"
"Food",65446,"Terminated","Hoover Mill, Inc.","Chipley","FL","US","Voluntary: Firm Initiated","E-Mail","Alabama","F-1579-2013","Class II","ARNETT'S SELF RISING CORN MEAL NET WEIGHT 24 OZ. (1LB. 8 OZ) 680g","UPC #70582-20001 Lot # ''Sell By 2-21-14'' Exp date 2-21-14",".","7,068 bags","Due to high levels of aflatoxin ",4/10/2013,"04/10/2013",7/10/2013,"07/10/2013"
"Food",65446,"Terminated","Hoover Mill, Inc.","Chipley","FL","US","Voluntary: Firm Initiated","E-Mail","Alabama","F-1580-2013","Class II","Dixie Lily Stone Ground Meal 24 oz & 5lbs","24 oz-UPC #05663-10739 Lot # ''Sell By 2-27-14'' ; 5 lbs.-UPC #05663-10239 Lot # ''Sell By 3-1-14'' ",".","5440 bags","Due to high levels of aflatoxin ",4/10/2013,"04/10/2013",7/10/2013,"07/10/2013"
"Food",65446,"Terminated","Hoover Mill, Inc.","Chipley","FL","US","Voluntary: Firm Initiated","E-Mail","Alabama","F-1578-2013","Class II","ARNETT'S PLAIN CORN MEAL NET WT. 24 OZ. (1lb. 8 oz)(680g","UPC #70582-10001 Lot # ''Sell By 2-21-14'' Exp date 2-21-14",".","6,084 bags","Due to high levels of aflatoxin ",4/10/2013,"04/10/2013",7/10/2013,"07/10/2013"
"Food",65447,"Ongoing","American Importing Co, Inc","Minneapolis","MN","US","Voluntary: Firm Initiated","Letter","IL, IN, IA, KS, MN, NJ, NY, NC, OH, SC, TX, VT.","F-1729-2013","Class II","Smart Sense Fruit & Granola Trail Mix, Net WT 4.0 oz , UPC 8 83967 29091 8, Distributed by Kmart corporation, Hoffman Estates, Il 60179, Minneapolis, MN 55414.","Lot # Best By Date 9/10/2012 7/10/2013 10/16/2012 8/16/2013 10/23/2012 8/23/2013 11/5/2012 9/5/2013 12/3/2012 10/3/2013 1/3/2013 11/3/2013 1/4/2013 11/4/2013 1/22/2013 11/22/2013 ",,"1462 cases (12/case)","American Importing Co., d/b/a Amport Foods is voluntarily recalling a limited number of packages of its Amport Foods 16 oz Vanilla Almond Granola because they may contain pliable metal wire mesh fragments from a defective flour sifter from a 3rd party vendor.",2/25/2013,"02/25/2013",7/31/2013,"07/31/2013"
"Food",65447,"Ongoing","American Importing Co, Inc","Minneapolis","MN","US","Voluntary: Firm Initiated","Letter","IL, IN, IA, KS, MN, NJ, NY, NC, OH, SC, TX, VT.","F-1728-2013","Class II","Orchard Reserve, Fiber Health Blend, Net WT 6.5 oz , UPC 0 71725 74211 7, Distributed by Amport Foods, Minneapolis, MN 55414.","Best By 1/28/14 Lot #:30X322 ",,"910 cases (12/case)","American Importing Co., d/b/a Amport Foods is voluntarily recalling a limited number of packages of its Amport Foods 16 oz Vanilla Almond Granola because they may contain pliable metal wire mesh fragments from a defective flour sifter from a 3rd party vendor.",2/25/2013,"02/25/2013",7/31/2013,"07/31/2013"
"Food",65447,"Ongoing","American Importing Co, Inc","Minneapolis","MN","US","Voluntary: Firm Initiated","Letter","IL, IN, IA, KS, MN, NJ, NY, NC, OH, SC, TX, VT.","F-1727-2013","Class II","Vanilla almond granola, Net WT 16 oz(454g), UPC 0 71725 71239 4, Distributed by American Importing Co., Inc, Minneapolis, MN 55414. Vanilla Almond Granola, Net Wt 16 oz (454g), UPC 7 25439 20038 7, Distributed by DZA Brands LLC, Salisbury,NC 28147. Hy-Vee Granola Vanilla Almond, 24 oz, UPC 71725 71239 Amport, Granola, Vanilla Almond, 22 oz, UPC 71725 72512","8/10/13 223X218 9/13/13 257X218 4/16/13 1072O3 5/14/13 1352O2 7/12/13 1942P2 or 1942O2 8/10/13 223X218 9/13/13 257X218 11/4/2013 353385819 12/12/13 0722D1 1/24/2013 1142-362329 1/23/2013 1142-362331 1/24/2013 1152-363511 2/1/2013 1222-364253 2/7/2013 1282-364381 2/24/2013 1452-366291 3/7/2013 1592-366870 6/7/2013 2512-374976 6/13/2013 2572-374410 6/13/2013 2572-375613 7/1/2013 2752-376949 7/7/2013 2912-376014 7/17/2013 2912-378591 7/17/2013 2912-378591 8/5/2013 3102-379574 8/6/2013 3112-379952 9/12/2013 3472-382323 9/13/2013 3472-382969 4/16/13 1072O3 5/14/13 1352O2 8/10/13 223X218 9/13/13 257X218 1/22/14 022X318 5/14/13 1352O2 8/10/13 223X218 9/13/13 257X218 1/22/14 022X318 4/16/13 1072O3 8/10/13 223x218 9/13/13 257x218 8/15/13 320X246 4/16/13 1072O3 8/10/13 233X218 9/13/13 257X218 1/22/14 022X318 5/14/13 1352O2 7/12/13 1942P2 or 1942O2 8/10/13 223X218 9/13/18 257X218 4/16/13 1072O3 3/6/13 0662O2 4/16/13 1072P3 5/14/13 1352OO1 6/6/13 1582I1 8/1/13 214X218 8/10/13 233X218 9/13/13 257X218 10/8/13 282X218 10/30/13 304X218 11/15/13 320X218 1/24/2013 1142-362329 1/24/2013 1152-363511 2/1/2013 1222-363918 3/7/2013 1592-366870 6/13/2013 2572-374410 6/13/2013 2572-375613 7/17/2013 2912-376014 8/6/2012 3112-379952 1/23/2013 1142-362331 1/24/2013 1142-362329 2/1/2013 1222-363918 2/7/2013 1282-364381 3/7/2013 1592-366870 6/7/2013 2512-372839 6/13/2013 2572-374410 6/13/2013 2572-375613 7/1/2013 2752-376665 7/17/2013 2912-376014 7/17/2013 2912-378591 8/5/2013 3102-379574 8/6/2013 3112-379952 9/13/2013 3472-382969 11/4/2013 0353-385819 5/14/13 1352N2 6/7/2013 2512-372839 6/13/2013 2572-374410 7/1/2013 2752-376665 7/1/2013 2752-376949 7/17/2013 2912-376014 9/13/2013 3472-382969 9/13/13 257X218 ",,"16,884 cases (8/case) and 1500 bags.","American Importing Co., d/b/a Amport Foods is voluntarily recalling a limited number of packages of its Amport Foods 16 oz Vanilla Almond Granola because they may contain pliable metal wire mesh fragments from a defective flour sifter from a 3rd party vendor.",2/25/2013,"02/25/2013",7/31/2013,"07/31/2013"
"Food",65448,"Ongoing","Hines Nut Co","Dallas","TX","US","Voluntary: Firm Initiated","Letter","AR, MN, PA, and TX","F-1658-2013","Class I","Roasted and Salted In Shell Pistachio Nuts, repackaged into 48 ounce red topped gift jars labeled ''Orchard Fresh HINES''; 16 ounce trays labeled ''Natural Pistachios, Roasted and Salted''; and 16 ounce bags labeled ''Hines Natural Pistachios''.","No lot number appears on the gift jars; the trays and 1 pound bags have a Hines Nut Company lot number ''04396'' or ''4396''. ",".","4,000 lbs","The product recall is being initiated because the product has the potential to be contaminated with Salmonella.",6/11/2013,"06/11/2013",7/17/2013,"07/17/2013"
"Devices",65449,"Ongoing","Bryan Medical Inc","Cincinnati","OH","US","Voluntary: Firm Initiated","Telephone","Distributed in KY and AL.","Z-1667-2013","Class I","Tracoe Mini 3.0mm Tube, for pediatric use. Pediatric tracheostomy tube used to provide safe airway access.","The following product/catalog number and lot number was affects: Ref #350-3.0, lot #000-1000071752",".","5 units","The pediatric tracheostomy tubes were mislabeled as the smaller infant tracheostomy tubes. ",4/17/2013,"04/17/2013",7/17/2013,"07/17/2013"
"Veterinary",65452,"Ongoing","Hartz Mountain Corp.","Secaucus","NJ","US","Voluntary: Firm Initiated","Press Release","Nationwide","V-006-2014","Class I","Wardley Betta Fish Food 1.2 oz Made in the USA by The Hartz Mountain Corporation, Secaucus, New Jersey 07094 and imported by Canada Inc., St. Thomas, Ontario N59 3W7, Canada UPC number 0-43324-01648"," Lot Code PP06331 ",".","8,112 containers","The Hartz Mountain Corporation, located in Secaucus, N.J. is voluntarily recalling one specific lot of Wardley Betta Fish Food 1.2 oz. size due to concerns that one or more containers within the lot may have been potentially contaminated with Salmonella. ",6/12/2013,"06/12/2013",12/4/2013,"12/04/2013"
"Biologics",65453,"Terminated","Lifepoint, Inc.","Charleston","SC","US","Voluntary: Firm Initiated","Telephone","South Carolina","B-2041-13","Class III","Cornea","20130190L1; 20130190R1",".","2 corneas","Corneas, recovered from a donor whose donor eligibility determination failed to ensure that the donor was free from risk factors for, and clinical evidence of infection due to relevant communicable disease agents and diseases, were distributed. ",6/12/2013,"06/12/2013",8/14/2013,"08/14/2013"
"Biologics",65454,"Terminated","LifeShare Blood Centers","Shreveport","LA","US","Voluntary: Firm Initiated","FAX","Louisiana; Texas","B-2267-13","Class II","Red Blood Cells Leukocytes Reduced","W036513020524; W036512129435; W036512096702",".","3 units","Blood products, collected from an ineligible donor, were distributed. ",4/3/2013,"04/03/2013",9/11/2013,"09/11/2013"
"Biologics",65455,"Terminated","LifeShare Blood Centers","Shreveport","LA","US","Voluntary: Firm Initiated","FAX","Louisiana; Arkansas","B-2219-13","Class II","Red Blood Cells (Apheresis) Leukocytes Reduced","W036512076526 Part 1; W036512076526 Part 2; W036512059908; ",".","3","Blood products, which were labeled as leukoreduced, but were not tested to verify the White Blood Cell count, were distributed.",8/29/2012,"08/29/2012",9/18/2013,"09/18/2013"
"Devices",65456,"Ongoing","Stryker Instruments Div. of Stryker Corporation","Portage","MI","US","Voluntary: Firm Initiated","Letter","Worldwide distribution: US (nationwide) including states of: AZ, FL, GA, NC, NY, SC, TX and VA; and countries of: India, Netherlands and Japan.","Z-1741-2013","Class II","CORE Universal Driver REF 5400- 99 Rx Only This drill may also be used with theTotal Performance System (TPS'').The Stryker Total Performance System (TPS) is intended for usein the cutting, drilling, reaming, decorticating and smoothing of bone and other bone related tissues for a variety of applications such as ENT, dental orthopedic, maxillofacial, spinal, and plastic surgery. The instruments are also used in the placement of screws, wires, pins, and other fixation devices.","Serial Number 0326801633, 0330802913, 0406200763, 0410401383, 0410600013, 0534203093,0627600783, 0730101013, 0730101033, 0805000553, 0809829593, 0935603083,1011903103, 1011903493, 1013814003, 1025400463, 1025400643, 1126901343, and 1128022593 ",".","11","The safety margin values detailed in the Engineering Design were entered incorrectly into the programming software. Handpieces that have been programmed with the incorrect parameters could result in unintended activation. There is a potential for injury to the patient or user as a result of unintended forward or reverse activation. There is also the potential that the handpiece may not reach 100% speed at full trigger depression in both forward or reverse, the handpiece may exceed full speed in reverse or may have excessive dead trigger travel before motor rotation in reverse, resulting in user annoyance.",7/1/2013,"07/01/2013",7/24/2013,"07/24/2013"
"Devices",65456,"Ongoing","Stryker Instruments Div. of Stryker Corporation","Portage","MI","US","Voluntary: Firm Initiated","Letter","Worldwide distribution: US (nationwide) including states of: AZ, FL, GA, NC, NY, SC, TX and VA; and countries of: India, Netherlands and Japan.","Z-1742-2013","Class II","RemB Electric Universal Driver REF 6400-099-000 For use with the CORE and TPS System sRx Only The RemB Electric Universal Driver is intended for use with the Consolidated Operating Room Equipment (CORE TM) System. When used with a variety of accessories, the RemB Electric Universal Driver is intended for surgical procedures involving driving wire or pins into bone and hard tissue. This includes but is not limited to Dental, ENT (Ear, Nose, Throat), Neuro, and Endoscopic applications. This device can also be used with the Total Performance System (TPSTM). ","0910505713, 1029801073, 1225400823, 1314201603, 1314300713, 1314300723, 1314300733, 1314300743, 1314300753, 1314300763, 1314300773, 1314300783, 1314300793, 1314300803, 1314300813, 1314300823, 1314300833, 1314300843, 1314300853, 1314300863, 1314300873, 1314300883, 1314300893, 1314300903, 1314804033, 1314900053, 1314906453, 1314908193",".","9","The safety margin values detailed in the Engineering Design were entered incorrectly into the programming software. Handpieces that have been programmed with the incorrect parameters could result in unintended activation. There is a potential for injury to the patient or user as a result of unintended forward or reverse activation. There is also the potential that the handpiece may not reach 100% speed at full trigger depression in both forward or reverse, the handpiece may exceed full speed in reverse or may have excessive dead trigger travel before motor rotation in reverse, resulting in user annoyance.",7/1/2013,"07/01/2013",7/24/2013,"07/24/2013"
"Devices",65456,"Ongoing","Stryker Instruments Div. of Stryker Corporation","Portage","MI","US","Voluntary: Firm Initiated","Letter","Worldwide distribution: US (nationwide) including states of: AZ, FL, GA, NC, NY, SC, TX and VA; and countries of: India, Netherlands and Japan.","Z-1740-2013","Class II","Stryker TPS Universal Driver REF 5100- 99 Rx , The Stryker Total Performance System (TPS) is intended for use in the cutting, drilling, reaming, decorticating and smoothing of bone and other bone related tissues for a variety of applications such as ENT, dental orthopedic, maxillofacial, spinal, and plastic surgery. The instruments are also used in the placement of screws, wires, pins, and other fixation devices.","Serial Number 0214200753",".","0","The safety margin values detailed in the Engineering Design were entered incorrectly into the programming software. Handpieces that have been programmed with the incorrect parameters could result in unintended activation. There is a potential for injury to the patient or user as a result of unintended forward or reverse activation. There is also the potential that the handpiece may not reach 100% speed at full trigger depression in both forward or reverse, the handpiece may exceed full speed in reverse or may have excessive dead trigger travel before motor rotation in reverse, resulting in user annoyance.",7/1/2013,"07/01/2013",7/24/2013,"07/24/2013"
"Drugs",65457,"Ongoing","American Health Packaging","Columbus","OH","US","Voluntary: Firm Initiated","Letter","Nationwide","D-892-2013","Class III","buPROPion Hydrochloride Extended Release Tablets, USP 100 mg, 100 count carton, 10 blister cards of 10 individually blistered and labeled tablets, Rx only, Actavis South Atlantic LLC, Packaged and Distributed by: American Health Packaging, Columbus, OH --- NDC 68084-470-01","The following codes are affects by the recall: Lot #114500, Exipration Date 08/2013, repackaging date 12/04/2011. ",,"389 cartons","Failed Stability Specifications; out of specification results at the 9 month stability time point for color, dissolution and related compounds. ",2/4/2013,"02/04/2013",8/21/2013,"08/21/2013"
"Devices",65458,"Ongoing","Medtronic Inc. Cardiac Rhythm Disease Management","Saint Paul","MN","US","Voluntary: Firm Initiated","Letter","Internationally distributed: to countries of Germany and Poland.","Z-1564-2013","Class II","Medtronic, Launcher Guiding Catheter, Model # LA8EBU45SH, Lot # 0006722866, 8F and Model # LA6IMAD, Lot # 0006724224, 6F Product Usage: The Medtronic Guiding Catheter is designed to provide a pathway through which therapeutic devices are introduced. The guiding catheter is intended to be used in the coronary or peripheral vascular system.","Model # LA8EBU45SH, Lot # 0006722866 and Model # LA6IMAD, Lot # 0006724224.",,"15","Medtronic has identified a labeling issue for 24 units of the Launcher coronary Guide Catheter. The two affected catheter lots are mislabeled and do not accurately reflect the catheters contained within each package.",6/12/2013,"06/12/2013",7/3/2013,"07/03/2013"
"Devices",65459,"Ongoing","Biomet, Inc.","Warsaw","IN","US","Voluntary: Firm Initiated","Letter","Worldwide distribution: USA including NC, IN, PA, and OH; and countries of: Canada and Netherlands.","Z-1710-2013","Class II","REF 154221 Oxford Fixed Bearing Partial Knee Cemented Lateral Tibia Size D3 ARCOM UHMWPE / CO-CR-MO Alloy Only for use in Lateral compartment Sterile R The Oxford Fixed Bearing Knee is a Partial knee replacement system consisting of a femoral component and a fixed bearing tibial component for use in the lateral compartment of the knee. The Oxford Fixed Lateral bearings are indicated for use in the lateral compartment and intended to be implemented with bone cement.","M987290, M035670, 987410, M444830, M920680, M754840",".","29","Biomet investigation found the design of the tibial bearing creates the potential for anterior impingement between the bone and the poly bearing component in terminal extension.",6/7/2013,"06/07/2013",7/17/2013,"07/17/2013"
"Devices",65459,"Ongoing","Biomet, Inc.","Warsaw","IN","US","Voluntary: Firm Initiated","Letter","Worldwide distribution: USA including NC, IN, PA, and OH; and countries of: Canada and Netherlands.","Z-1723-2013","Class II","REF 154238 Oxford Fixed Bearing Partial Knee Cemented Lateral Tibia Size F6 ARCOM UHMWPE / CO-CR-MO Alloy Only for use in Lateral compartment Sterile R The Oxford Fixed Bearing Knee is a Partial knee replacement system consisting of a femoral component and a fixed bearing tibial component for use in the lateral compartment of the knee. The Oxford Fixed Lateral bearings are indicated for use in the lateral compartment and intended to be implemented with bone cement.","M480960, M657120, M886450, M166890, M920650 ",".","25","Biomet investigation found the design of the tibial bearing creates the potential for anterior impingement between the bone and the poly bearing component in terminal extension.",6/7/2013,"06/07/2013",7/17/2013,"07/17/2013"
"Devices",65459,"Ongoing","Biomet, Inc.","Warsaw","IN","US","Voluntary: Firm Initiated","Letter","Worldwide distribution: USA including NC, IN, PA, and OH; and countries of: Canada and Netherlands.","Z-1714-2013","Class II","REF 154225Oxford Fixed Bearing Partial Knee Cemented Lateral Tibia Size D7 ARCOM UHMWPE / CO-CR-MO Alloy Only for use in Lateral compartment Sterile R The Oxford Fixed Bearing Knee is a Partial knee replacement system consisting of a femoral component and a fixed bearing tibial component for use in the lateral compartment of the knee. The Oxford Fixed Lateral bearings are indicated for use in the lateral compartment and intended to be implemented with bone cement.","M619800 , M106200, M444870 , M657020 , M987640 , M987330 , M987640 ",".","26","Biomet investigation found the design of the tibial bearing creates the potential for anterior impingement between the bone and the poly bearing component in terminal extension.",6/7/2013,"06/07/2013",7/17/2013,"07/17/2013"
"Devices",65459,"Ongoing","Biomet, Inc.","Warsaw","IN","US","Voluntary: Firm Initiated","Letter","Worldwide distribution: USA including NC, IN, PA, and OH; and countries of: Canada and Netherlands.","Z-1699-2013","Class II","REF 154204 Oxford Fixed Bearing Partial Knee Cemented Lateral Tibia Size A7 ARCOM UHMWPE / CO-CR-MO Alloy Only for use in Lateral compartment Sterile R The Oxford Fixed Bearing Knee is a Partial knee replacement system consisting of a femoral component and a fixed bearing tibial component for use in the lateral compartment of the knee. The Oxford Fixed Lateral bearings are indicated for use in the lateral compartment and intended to be implemented with bone cement."," M375470, M444680 , M886360, M938500 ",".","22","Biomet investigation found the design of the tibial bearing creates the potential for anterior impingement between the bone and the poly bearing component in terminal extension.",6/7/2013,"06/07/2013",7/17/2013,"07/17/2013"
"Devices",65459,"Ongoing","Biomet, Inc.","Warsaw","IN","US","Voluntary: Firm Initiated","Letter","Worldwide distribution: USA including NC, IN, PA, and OH; and countries of: Canada and Netherlands.","Z-1717-2013","Class II","REF 154230 Oxford Fixed Bearing Partial Knee Cemented Lateral Tibia Size E5 ARCOM UHMWPE / CO-CR-MO Alloy Only for use in Lateral compartment Sterile R The Oxford Fixed Bearing Knee is a Partial knee replacement system consisting of a femoral component and a fixed bearing tibial component for use in the lateral compartment of the knee.The Oxford Fixed Lateral bearings are indicated for use in the lateral compartment and intended to be implemented with bone cement.","M480950 , M657050, M444900 , M030220 ",".","25","Biomet investigation found the design of the tibial bearing creates the potential for anterior impingement between the bone and the poly bearing component in terminal extension.",6/7/2013,"06/07/2013",7/17/2013,"07/17/2013"
"Devices",65459,"Ongoing","Biomet, Inc.","Warsaw","IN","US","Voluntary: Firm Initiated","Letter","Worldwide distribution: USA including NC, IN, PA, and OH; and countries of: Canada and Netherlands.","Z-1711-2013","Class II","REF 154222 Oxford Fixed Bearing Partial Knee Cemented Lateral Tibia Size D4 ARCOM UHMWPE / CO-CR-MO Alloy Only for use in Lateral compartment Sterile R The Oxford Fixed Bearing Knee is a Partial knee replacement system consisting of a femoral component and a fixed bearing tibial component for use in the lateral compartment of the knee. The Oxford Fixed Lateral bearings are indicated for use in the lateral compartment and intended to be implemented with bone cement.","M598320, M480940, M987300, M444840, M656990 ",".","37","Biomet investigation found the design of the tibial bearing creates the potential for anterior impingement between the bone and the poly bearing component in terminal extension.",6/7/2013,"06/07/2013",7/17/2013,"07/17/2013"
"Devices",65459,"Ongoing","Biomet, Inc.","Warsaw","IN","US","Voluntary: Firm Initiated","Letter","Worldwide distribution: USA including NC, IN, PA, and OH; and countries of: Canada and Netherlands.","Z-1701-2013","Class II","REF 154208 Oxford Fixed Bearing Partial Knee Cemented Lateral Tibia Size B4 ARCOM UHMWPE / CO-CR-MO Alloy Only for use in Lateral compartment Sterile R The Oxford Fixed Bearing Knee is a Partial knee replacement system consisting of a femoral component and a fixed bearing tibial component for use in the lateral compartment of the knee. The Oxford Fixed Lateral bearings are indicated for use in the lateral compartment and intended to be implemented with bone cement.","M619750 ; M375480; M886380, M956060 , M444700 ",".","24","Biomet investigation found the design of the tibial bearing creates the potential for anterior impingement between the bone and the poly bearing component in terminal extension.",6/7/2013,"06/07/2013",7/17/2013,"07/17/2013"
"Devices",65459,"Ongoing","Biomet, Inc.","Warsaw","IN","US","Voluntary: Firm Initiated","Letter","Worldwide distribution: USA including NC, IN, PA, and OH; and countries of: Canada and Netherlands.","Z-1715-2013","Class II","REF 154228 Oxford Fixed Bearing Partial Knee Cemented Lateral Tibia Size E3 ARCOM UHMWPE / CO-CR-MO Alloy Only for use in Lateral compartment Sterile R The Oxford Fixed Bearing Knee is a Partial knee replacement system consisting of a femoral component and a fixed bearing tibial component for use in the lateral compartment of the knee. The Oxford Fixed Lateral bearings are indicated for use in the lateral compartment and intended to be implemented with bone cement.","M619800 , M106200, M444870 , M657020 , M987640 , M987330 , M987640 ",".","25","Biomet investigation found the design of the tibial bearing creates the potential for anterior impingement between the bone and the poly bearing component in terminal extension.",6/7/2013,"06/07/2013",7/17/2013,"07/17/2013"
"Devices",65459,"Ongoing","Biomet, Inc.","Warsaw","IN","US","Voluntary: Firm Initiated","Letter","Worldwide distribution: USA including NC, IN, PA, and OH; and countries of: Canada and Netherlands.","Z-1719-2013","Class II","REF 154232 Oxford Fixed Bearing Partial Knee Cemented Lateral Tibia Size E7 ARCOM UHMWPE / CO-CR-MO Alloy Only for use in Lateral compartment Sterile R The Oxford Fixed Bearing Knee is a Partial knee replacement system consisting of a femoral component and a fixed bearing tibial component for use in the lateral compartment of the knee. The Oxford Fixed Lateral bearings are indicated for use in the lateral compartment and intended to be implemented with bone cement.","M921180, M539440, M444920, M722450, M136990, M657080",".","31","Biomet investigation found the design of the tibial bearing creates the potential for anterior impingement between the bone and the poly bearing component in terminal extension.",6/7/2013,"06/07/2013",7/17/2013,"07/17/2013"
"Devices",65459,"Ongoing","Biomet, Inc.","Warsaw","IN","US","Voluntary: Firm Initiated","Letter","Worldwide distribution: USA including NC, IN, PA, and OH; and countries of: Canada and Netherlands.","Z-1697-2013","Class II","REF 154202 Oxford Fixed Bearing Partial Knee Cemented Lateral Tibia Size A5 ARCOM UHMWPE / CO-CR-MO Alloy Only for use in Lateral compartment Sterile R The Oxford Fixed Bearing Knee is a Partial knee replacement system consisting of a femoral component and a fixed bearing tibial component for use in the lateral compartment of the knee. The Oxford Fixed Lateral bearings are indicated for use in the lateral compartment and intended to be implemented with bone cement."," M879630 , M584360, M492950, M444650, M656940, M938480 ",".","28","Biomet investigation found the design of the tibial bearing creates the potential for anterior impingement between the bone and the poly bearing component in terminal extension.",6/7/2013,"06/07/2013",7/17/2013,"07/17/2013"
"Devices",65459,"Ongoing","Biomet, Inc.","Warsaw","IN","US","Voluntary: Firm Initiated","Letter","Worldwide distribution: USA including NC, IN, PA, and OH; and countries of: Canada and Netherlands.","Z-1720-2013","Class II","REF 154235Oxford Fixed Bearing Partial Knee Cemented Lateral Tibia Size F3 ARCOM UHMWPE / CO-CR-MO Alloy Only for use in Lateral compartment Sterile R The Oxford Fixed Bearing Knee is a Partial knee replacement system consisting of a femoral component and a fixed bearing tibial component for use in the lateral compartment of the knee. The Oxford Fixed Lateral bearings are indicated for use in the lateral compartment and intended to be implemented with bone cement.","M632970 , M539450 , M920610 , M657090 , M017520 , M166860 , M886420 ",".","26","Biomet investigation found the design of the tibial bearing creates the potential for anterior impingement between the bone and the poly bearing component in terminal extension.",6/7/2013,"06/07/2013",7/17/2013,"07/17/2013"
"Devices",65459,"Ongoing","Biomet, Inc.","Warsaw","IN","US","Voluntary: Firm Initiated","Letter","Worldwide distribution: USA including NC, IN, PA, and OH; and countries of: Canada and Netherlands.","Z-1695-2013","Class II","REF 154200 Oxford Fixed Bearing Partial Knee Cemented Lateral Tibia Size A3 ARCOM UHMWPE / CO-CR-MO Alloy Only for use in Lateral compartment Sterile R The Oxford Fixed Bearing Knee is a Partial knee replacement system consisting of a femoral component and a fixed bearing tibial component for use in the lateral compartment of the knee. The Oxford Fixed Lateral bearings are indicated for use in the lateral compartment and intended to be implemented with bone cement.","M619730 , M480920, M656920, M938460, M444630 ",".","26","Biomet investigation found the design of the tibial bearing creates the potential for anterior impingement between the bone and the poly bearing component in terminal extension.",6/7/2013,"06/07/2013",7/17/2013,"07/17/2013"
"Devices",65459,"Ongoing","Biomet, Inc.","Warsaw","IN","US","Voluntary: Firm Initiated","Letter","Worldwide distribution: USA including NC, IN, PA, and OH; and countries of: Canada and Netherlands.","Z-1703-2013","Class II","REF 154210 Oxford Fixed Bearing Partial Knee Cemented Lateral Tibia Size 6ARCOM UHMWPE / CO-CR-MO Alloy Only for use in Lateral compartment Sterile R The Oxford Fixed Bearing Knee is a Partial knee replacement system consisting of a femoral component and a fixed bearing tibial component for use in the lateral compartment of the knee. The Oxford Fixed Lateral bearings are indicated for use in the lateral compartment and intended to be implemented with bone cement."," M375490, M444720 , M886400, M956080 ",".","22","Biomet investigation found the design of the tibial bearing creates the potential for anterior impingement between the bone and the poly bearing component in terminal extension.",6/7/2013,"06/07/2013",7/17/2013,"07/17/2013"
"Devices",65459,"Ongoing","Biomet, Inc.","Warsaw","IN","US","Voluntary: Firm Initiated","Letter","Worldwide distribution: USA including NC, IN, PA, and OH; and countries of: Canada and Netherlands.","Z-1724-2013","Class II","REF 154239 Oxford Fixed Bearing Partial Knee Cemented Lateral Tibia Size F7 ARCOM UHMWPE / CO-CR-MO Alloy Only for use in Lateral compartment Sterile R The Oxford Fixed Bearing Knee is a Partial knee replacement system consisting of a femoral component and a fixed bearing tibial component for use in the lateral compartment of the knee. The Oxford Fixed Lateral bearings are indicated for use in the lateral compartment and intended to be implemented with bone cement.","M492980, M657130, M920670, M886460, M166900 ",".","24","Biomet investigation found the design of the tibial bearing creates the potential for anterior impingement between the bone and the poly bearing component in terminal extension.",6/7/2013,"06/07/2013",7/17/2013,"07/17/2013"
"Devices",65459,"Ongoing","Biomet, Inc.","Warsaw","IN","US","Voluntary: Firm Initiated","Letter","Worldwide distribution: USA including NC, IN, PA, and OH; and countries of: Canada and Netherlands.","Z-1698-2013","Class II","REF 154203 Oxford Fixed Bearing Partial Knee Cemented Lateral Tibia Size A6 ARCOM UHMWPE / CO-CR-MO Alloy Only for use in Lateral compartment Sterile R The Oxford Fixed Bearing Knee is a Partial knee replacement system consisting of a femoral component and a fixed bearing tibial component for use in the lateral compartment of the knee. The Oxford Fixed Lateral bearings are indicated for use in the lateral compartment and intended to be implemented with bone cement."," M879640, M375460, M444660, M886350, M938490 ",".","30","Biomet investigation found the design of the tibial bearing creates the potential for anterior impingement between the bone and the poly bearing component in terminal extension.",6/7/2013,"06/07/2013",7/17/2013,"07/17/2013"
"Devices",65459,"Ongoing","Biomet, Inc.","Warsaw","IN","US","Voluntary: Firm Initiated","Letter","Worldwide distribution: USA including NC, IN, PA, and OH; and countries of: Canada and Netherlands.","Z-1718-2013","Class II","REF 154231Oxford Fixed Bearing Partial Knee Cemented Lateral Tibia Size E6 ARCOM UHMWPE / CO-CR-MO Alloy Only for use in Lateral compartment Sterile R The Oxford Fixed Bearing Knee is a Partial knee replacement system consisting of a femoral component and a fixed bearing tibial component for use in the lateral compartment of the knee. The Oxford Fixed Lateral bearings are indicated for use in the lateral compartment and intended to be implemented with bone cement."," M321600, M539430, M444910, M657070,M722440, M136980, M444910 ",".","28","Biomet investigation found the design of the tibial bearing creates the potential for anterior impingement between the bone and the poly bearing component in terminal extension.",6/7/2013,"06/07/2013",7/17/2013,"07/17/2013"
"Devices",65459,"Ongoing","Biomet, Inc.","Warsaw","IN","US","Voluntary: Firm Initiated","Letter","Worldwide distribution: USA including NC, IN, PA, and OH; and countries of: Canada and Netherlands.","Z-1716-2013","Class II","REF 154229 Oxford Fixed Bearing Partial Knee Cemented Lateral Tibia Size E4 ARCOM UHMWPE / CO-CR-MO Alloy Only for use in Lateral compartment Sterile R The Oxford Fixed Bearing Knee is a Partial knee replacement system consisting of a femoral component and a fixed bearing tibial component for use in the lateral compartment of the knee. The Oxford Fixed Lateral bearings are indicated for use in the lateral compartment and intended to be implemented with bone cement.","M561240, M632960 , M136950 M657040 , M722420 , M444890 ",".","25","Biomet investigation found the design of the tibial bearing creates the potential for anterior impingement between the bone and the poly bearing component in terminal extension.",6/7/2013,"06/07/2013",7/17/2013,"07/17/2013"
"Devices",65459,"Ongoing","Biomet, Inc.","Warsaw","IN","US","Voluntary: Firm Initiated","Letter","Worldwide distribution: USA including NC, IN, PA, and OH; and countries of: Canada and Netherlands.","Z-1706-2013","Class II","REF 154215 Oxford Fixed Bearing Partial Knee Cemented Lateral Tibia Size C4 ARCOM UHMWPE / CO-CR-MO Alloy Only for use in Lateral compartment Sterile R The Oxford Fixed Bearing Knee is a Partial knee replacement system consisting of a femoral component and a fixed bearing tibial component for use in the lateral compartment of the knee. The Oxford Fixed Lateral bearings are indicated for use in the lateral compartment and intended to be implemented with bone cement.","M321580 , M619780, M492960, M656960, M969120 , M444790 6",".","30","Biomet investigation found the design of the tibial bearing creates the potential for anterior impingement between the bone and the poly bearing component in terminal extension.",6/7/2013,"06/07/2013",7/17/2013,"07/17/2013"
"Devices",65459,"Ongoing","Biomet, Inc.","Warsaw","IN","US","Voluntary: Firm Initiated","Letter","Worldwide distribution: USA including NC, IN, PA, and OH; and countries of: Canada and Netherlands.","Z-1704-2013","Class II","REF 154211 Oxford Fixed Bearing Partial Knee Cemented Lateral Tibia Size B7 ARCOM UHMWPE / CO-CR-MO Alloy Only for use in Lateral compartment Sterile R The Oxford Fixed Bearing Knee is a Partial knee replacement system consisting of a femoral component and a fixed bearing tibial component for use in the lateral compartment of the knee. The Oxford Fixed Lateral bearings are indicated for use in the lateral compartment and intended to be implemented with bone cement.","M375500 ,M886410, M444760, M956090 ",".","22","Biomet investigation found the design of the tibial bearing creates the potential for anterior impingement between the bone and the poly bearing component in terminal extension.",6/7/2013,"06/07/2013",7/17/2013,"07/17/2013"
"Devices",65459,"Ongoing","Biomet, Inc.","Warsaw","IN","US","Voluntary: Firm Initiated","Letter","Worldwide distribution: USA including NC, IN, PA, and OH; and countries of: Canada and Netherlands.","Z-1709-2013","Class II","REF 154218 Oxford Fixed Bearing Partial Knee Cemented Lateral Tibia Size C7 ARCOM UHMWPE / CO-CR-MO Alloy Only for use in Lateral compartment Sterile R The Oxford Fixed Bearing Knee is a Partial knee replacement system consisting of a femoral component and a fixed bearing tibial component for use in the lateral compartment of the knee. The Oxford Fixed Lateral bearings are indicated for use in the lateral compartment and intended to be implemented with bone cement.","M584380, M754830, M969160, M444820, M987510",".","20","Biomet investigation found the design of the tibial bearing creates the potential for anterior impingement between the bone and the poly bearing component in terminal extension.",6/7/2013,"06/07/2013",7/17/2013,"07/17/2013"
"Devices",65459,"Ongoing","Biomet, Inc.","Warsaw","IN","US","Voluntary: Firm Initiated","Letter","Worldwide distribution: USA including NC, IN, PA, and OH; and countries of: Canada and Netherlands.","Z-1722-2013","Class II","REF 154237 Oxford Fixed Bearing Partial Knee Cemented Lateral Tibia Size F5 ARCOM UHMWPE / CO-CR-MO Alloy Only for use in Lateral compartment Sterile R The Oxford Fixed Bearing Knee is a Partial knee replacement system consisting of a femoral component and a fixed bearing tibial component for use in the lateral compartment of the knee. The Oxford Fixed Lateral bearings are indicated for use in the lateral compartment and intended to be implemented with bone cement.","M561250, M657110, M017540, M166880, M920640, M886440 ",".","23","Biomet investigation found the design of the tibial bearing creates the potential for anterior impingement between the bone and the poly bearing component in terminal extension.",6/7/2013,"06/07/2013",7/17/2013,"07/17/2013"
"Devices",65459,"Ongoing","Biomet, Inc.","Warsaw","IN","US","Voluntary: Firm Initiated","Letter","Worldwide distribution: USA including NC, IN, PA, and OH; and countries of: Canada and Netherlands.","Z-1702-2013","Class II","REF 154209 Oxford Fixed Bearing Partial Knee Cemented Lateral Tibia Size B5 ARCOM UHMWPE / CO-CR-MO Alloy Only for use in Lateral compartment Sterile R The Oxford Fixed Bearing Knee is a Partial knee replacement system consisting of a femoral component and a fixed bearing tibial component for use in the lateral compartment of the knee. The Oxford Fixed Lateral bearings are indicated for use in the lateral compartment and intended to be implemented with bone cement.","M561290, M956070, M444710 6, M136780, M886390 ",".","23","Biomet investigation found the design of the tibial bearing creates the potential for anterior impingement between the bone and the poly bearing component in terminal extension.",6/7/2013,"06/07/2013",7/17/2013,"07/17/2013"
"Devices",65459,"Ongoing","Biomet, Inc.","Warsaw","IN","US","Voluntary: Firm Initiated","Letter","Worldwide distribution: USA including NC, IN, PA, and OH; and countries of: Canada and Netherlands.","Z-1708-2013","Class II","REF 154217 Oxford Fixed Bearing Partial Knee Cemented Lateral Tibia Size C6 ARCOM UHMWPE / CO-CR-MO Alloy Only for use in Lateral compartment Sterile R The Oxford Fixed Bearing Knee is a Partial knee replacement system consisting of a femoral component and a fixed bearing tibial component for use in the lateral compartment of the knee. The Oxford Fixed Lateral bearings are indicated for use in the lateral compartment and intended to be implemented with bone cement.","M492970, M598310, M598310, M656980, M969150",".","24","Biomet investigation found the design of the tibial bearing creates the potential for anterior impingement between the bone and the poly bearing component in terminal extension.",6/7/2013,"06/07/2013",7/17/2013,"07/17/2013"
"Devices",65459,"Ongoing","Biomet, Inc.","Warsaw","IN","US","Voluntary: Firm Initiated","Letter","Worldwide distribution: USA including NC, IN, PA, and OH; and countries of: Canada and Netherlands.","Z-1713-2013","Class II","REF 154224 Oxford Fixed Bearing Partial Knee Cemented Lateral Tibia Size D6 ARCOM UHMWPE / CO-CR-MO Alloy Only for use in Lateral compartment Sterile R The Oxford Fixed Bearing Knee is a Partial knee replacement system consisting of a femoral component and a fixed bearing tibial component for use in the lateral compartment of the knee. The Oxford Fixed Lateral bearings are indicated for use in the lateral compartment and intended to be implemented with bone cement.","M632930 , M539420 , M444860 , M657010, M987630 , M987320 ",".","26","Biomet investigation found the design of the tibial bearing creates the potential for anterior impingement between the bone and the poly bearing component in terminal extension.",6/7/2013,"06/07/2013",7/17/2013,"07/17/2013"
"Devices",65459,"Ongoing","Biomet, Inc.","Warsaw","IN","US","Voluntary: Firm Initiated","Letter","Worldwide distribution: USA including NC, IN, PA, and OH; and countries of: Canada and Netherlands.","Z-1712-2013","Class II","REF 154223 Oxford Fixed Bearing Partial Knee Cemented Lateral Tibia Size D5 ARCOM UHMWPE / CO-CR-MO Alloy Only for use in Lateral compartment Sterile R The Oxford Fixed Bearing Knee is a Partial knee replacement system consisting of a femoral component and a fixed bearing tibial component for use in the lateral compartment of the knee. The Oxford Fixed Lateral bearings are indicated for use in the lateral compartment and intended to be implemented with bone cement.","M300790, M632920, M539410, M444850, M987620, M987310",".","46","Biomet investigation found the design of the tibial bearing creates the potential for anterior impingement between the bone and the poly bearing component in terminal extension.",6/7/2013,"06/07/2013",7/17/2013,"07/17/2013"
"Devices",65459,"Ongoing","Biomet, Inc.","Warsaw","IN","US","Voluntary: Firm Initiated","Letter","Worldwide distribution: USA including NC, IN, PA, and OH; and countries of: Canada and Netherlands.","Z-1705-2013","Class II","REF 154214 Oxford Fixed Bearing Partial Knee Cemented Lateral Tibia Size C3 ARCOM UHMWPE / CO-CR-MO Alloy Only for use in Lateral compartment Sterile R The Oxford Fixed Bearing Knee is a Partial knee replacement system consisting of a femoral component and a fixed bearing tibial component for use in the lateral compartment of the knee. The Oxford Fixed Lateral bearings are indicated for use in the lateral compartment and intended to be implemented with bone cement."," M321570, M894590,M619770, M480930, M656950 M444780, M969100 ",".","32","Biomet investigation found the design of the tibial bearing creates the potential for anterior impingement between the bone and the poly bearing component in terminal extension.",6/7/2013,"06/07/2013",7/17/2013,"07/17/2013"
"Devices",65459,"Ongoing","Biomet, Inc.","Warsaw","IN","US","Voluntary: Firm Initiated","Letter","Worldwide distribution: USA including NC, IN, PA, and OH; and countries of: Canada and Netherlands.","Z-1696-2013","Class II","REF 154201 Oxford Fixed Bearing Partial Knee Cemented Lateral Tibia Size A4 ARCOM UHMWPE / CO-CR-MO Alloy Only for use in Lateral compartment Sterile R The Oxford Fixed Bearing Knee is a Partial knee replacement system consisting of a femoral component and a fixed bearing tibial component for use in the lateral compartment of the knee. The Oxford Fixed Lateral bearings are indicated for use in the lateral compartment and intended to be implemented with bone cement.","M619740, M492940, M444640, M656930, M938470 ",".","22","Biomet investigation found the design of the tibial bearing creates the potential for anterior impingement between the bone and the poly bearing component in terminal extension.",6/7/2013,"06/07/2013",7/17/2013,"07/17/2013"
"Devices",65459,"Ongoing","Biomet, Inc.","Warsaw","IN","US","Voluntary: Firm Initiated","Letter","Worldwide distribution: USA including NC, IN, PA, and OH; and countries of: Canada and Netherlands.","Z-1700-2013","Class II","REF 154207 Oxford Fixed Bearing Partial Knee Cemented Lateral Tibia Size B3 ARCOM UHMWPE / CO-CR-MO Alloy Only for use in Lateral compartment Sterile R The Oxford Fixed Bearing Knee is a Partial knee replacement system consisting of a femoral component and a fixed bearing tibial component for use in the lateral compartment of the knee. The Oxford Fixed Lateral bearings are indicated for use in the lateral compartment and intended to be implemented with bone cement.","M561220 M584370 M151880 , M444690, M886370 , M956050, ",".","25","Biomet investigation found the design of the tibial bearing creates the potential for anterior impingement between the bone and the poly bearing component in terminal extension.",6/7/2013,"06/07/2013",7/17/2013,"07/17/2013"
"Devices",65459,"Ongoing","Biomet, Inc.","Warsaw","IN","US","Voluntary: Firm Initiated","Letter","Worldwide distribution: USA including NC, IN, PA, and OH; and countries of: Canada and Netherlands.","Z-1707-2013","Class II","REF 154216 Oxford Fixed Bearing Partial Knee Cemented Lateral Tibia Size C5 ARCOM UHMWPE / CO-CR-MO Alloy Only for use in Lateral compartment Sterile R The Oxford Fixed Bearing Knee is a Partial knee replacement system consisting of a femoral component and a fixed bearing tibial component for use in the lateral compartment of the knee. The Oxford Fixed Lateral bearings are indicated for use in the lateral compartment and intended to be implemented with bone cement.","M539400, M619790, M987360 , M444800, M969130, M151150, M987360 ",".","23","Biomet investigation found the design of the tibial bearing creates the potential for anterior impingement between the bone and the poly bearing component in terminal extension.",6/7/2013,"06/07/2013",7/17/2013,"07/17/2013"
"Devices",65459,"Ongoing","Biomet, Inc.","Warsaw","IN","US","Voluntary: Firm Initiated","Letter","Worldwide distribution: USA including NC, IN, PA, and OH; and countries of: Canada and Netherlands.","Z-1721-2013","Class II","REF 154236 Oxford Fixed Bearing Partial Knee Cemented Lateral Tibia Size F4 ARCOM UHMWPE / CO-CR-MO Alloy Only for use in Lateral compartment Sterile R The Oxford Fixed Bearing Knee is a Partial knee replacement system consisting of a femoral component and a fixed bearing tibial component for use in the lateral compartment of the knee.The Oxford Fixed Lateral bearings are indicated for use in the lateral compartment and intended to be implemented with bone cement.","M632980 , M539460 , M657100 , M017530 , M166870 , M920620 , M886430 ",".","25","Biomet investigation found the design of the tibial bearing creates the potential for anterior impingement between the bone and the poly bearing component in terminal extension.",6/7/2013,"06/07/2013",7/17/2013,"07/17/2013"
"Food",65460,"Ongoing","Julian's Recipe, LLC","Montgomery","NY","US","Voluntary: Firm Initiated","E-Mail","Texas","F-1544-2013","Class I","ALL NATURAL Julian's RECIPE European Style Pretzel Baguette, BUTTER & SEA SALT, NET WT 11.3 OZ (320 g), UPC 8 55971 00226 9, 2 BAGUETTES, KEEP FROZEN -- Product of Germany. Manufactured for Distribution by Julian's Recipe, LLC PO Box 323, Montgomery, NY 12549. --- The product consists of a frozen pre-baked baguette filled with salted butter. The baguette was treated on the surface in a manner to obtain the characteristic appearance of a pretzel. The deep frozen and unwrapped baguette should be baked in a pre-heated oven at 180-200C for about 10-12 minutes until the butter inside becomes liquid.","Lot Code L2312, Best Before Date 02/10/2014 (located on the bottom right hand corner of the box)",,"168 cases for total lot (only 23 cases contained incorrect product)","Undeclared allergen, soy flour, due to repacking error. ",6/6/2013,"06/06/2013",6/26/2013,"06/26/2013"
"Drugs",65461,"Ongoing","Warner Chilcott US LLC","Rockaway","NJ","US","Voluntary: Firm Initiated","Letter","Nationwide","D-822-2013","Class II","Enablex (darifenacin) Extended Release Tablet, 15 mg per tablet. Physician Sample 7 Tablets bottle, Rx only, Mfd by: Novartis Pharma Stein AG, Stein, Switzerland, NDC 0078-9420-07","Lot F1002 - Exp.12/13",,"188,600 bottles","Failed Impurities/Degradation Specifications: unspecified degradation product",5/17/2013,"05/17/2013",8/7/2013,"08/07/2013"
"Devices",65462,"Ongoing","Cardio Medical Products","Rockaway","NJ","US","Voluntary: Firm Initiated","Letter","Nationwide Distribution","Z-1669-2013","Class II","Cardio Medical Products, Inc. Defibrillation/Cardioversion/Monophasic or Biphasic Pacing/ECG Electrode Rx Only Single Patient Use Only Manufactured for Cardio Medical Products 385 Franklin Avenue, Suite L Rockaway, New Jersey 07866 www.cardiomedicalproducts.com (800) 227-3633 (973) 586-9624 FAX Defibrillator","510 K K103159 Part number O101 Lot numbers Y111412-2 Y111912-17 Y020613-03 ",".","657 units","Covidien received customer reports of Arcing/Sparking on the defibrillation electrode leadwire which may affect Cardio Medical Products Inc. defibrillator electrodes Model Number O101.",4/26/2013,"04/26/2013",7/17/2013,"07/17/2013"
"Biologics",65463,"Ongoing","Blood Bank Computer Systems, Inc","Auburn","WA","US","Voluntary: Firm Initiated","E-Mail","Nationwide","B-2148-13","Class II","Blood Bank software Primary Application with Model numbers 5.4.0.2 and 5.4.1.","BBCS Primary Application 5.4.0.2, 5.4.1",,"2 Devices","Blood Bank software Primary Application (Model Numbers 5.4.0.2 and 5.4.1), with a defect or glitch, was distributed. ",5/23/2013,"05/23/2013",7/31/2013,"07/31/2013"
"Devices",65464,"Ongoing","Greatbatch Medical","Minneapolis","MN","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution - AUSTRIA, BELGIUM, SWITZERLAND, GERMANY, SPAIN, GREECE, HUNGARY, IRELAND, ISRAEL and ITALY.","Z-1608-2013","Class II","Cordis a Johnson & Johnson Company, RadialSource Spring Wire Transradial Access Kit. Manufacturer Greatbatch Medical 2300 Berkshire Lane North, Minneapolis, MN 55441, Distributor Cordis Corporation 14201 North West 60th Avenue, Miami Lakes, Florida 33014. Baxter's lnfusors SV Elastomeric Infusion Device is a single-use, disposable elastomeric infusion pump indicated tor patients requiring slow, continuous intravenous, intra-arterial, subcutaneous, or epidural administration of medications at a constant flow rate. The device is also indicated for the administration of bolus doses of medication upon patient demand when used in conjunction with the Patient Control Module. lt is suitable for use in the hospital or home setting.","Manufacturing Lot : W18499722",,"550 kits (OUS)","Cordis Corporation, Inc and Greatbatch Medical are recalling one lot of the cordis RADIALSOURCE Spring Wire Transradial Access Kit product. Some units were manufactured with an undersized vessel dilator tip, too small to slide over the guidewire. ",5/31/2013,"05/31/2013",7/3/2013,"07/03/2013"
"Food",65465,"Ongoing","Oskri Corp.","Lake Mills","WI","US","Voluntary: Firm Initiated","Press Release","CA, CT, FL, ID, IL, IA, ME, MA, MI, MN, MO, MT, NV, NH, NJ, NY, NC, OH, OK, OR, PA, SD, TN, TX, VT, VA, WA, WV, WI.","F-1779-2013","Class I","OSKRI, Coconut Bar Dark Chocolate, Net Wt. 1.9 oz ( 53g), UPC 6 66016 30070 3. Ingredients: Coconuts 55%, Rice Syrup, Dark Chocolate 20% ( Sugar, Cocoa Butter, Chocolate, Soy Lecithin, Natural Vanilla).","P 1/1/13 to 6/6/13. EXP 7/7/14 to 12/12/14. LOT 001 to 154.",,"2,364 cases","OSKRI Corp is recalling Coconut Bar Dark Chocolate, Coconut Bar Dark Chocolate Minis, Fig Dark Chocolate Bars and Almond Dark Chocolate Bars because of undeclared milk.",6/14/2013,"06/14/2013",8/7/2013,"08/07/2013"
"Food",65465,"Ongoing","Oskri Corp.","Lake Mills","WI","US","Voluntary: Firm Initiated","Press Release","CA, CT, FL, ID, IL, IA, ME, MA, MI, MN, MO, MT, NV, NH, NJ, NY, NC, OH, OK, OR, PA, SD, TN, TX, VT, VA, WA, WV, WI.","F-1782-2013","Class I","OSKRI, Coconut Bar Dark Chocolate Minis, Net Wt .88 oz (25g), UPC 6 66016 40031. Ingredients: Coconuts , Rice Syrup, Dark Chocolate ( Sugar, Cocoa Liquor,Cocoa Butter, Chocolate, Soy Lecithin, Vanilla). ","P 1/1/13 to 6/6/13. EXP 7/7/14 to 12/12/14. LOT 001 to 154.",,"578 cases","OSKRI Corp is recalling Coconut Bar Dark Chocolate, Coconut Bar Dark Chocolate Minis, Fig Dark Chocolate Bars and Almond Dark Chocolate Bars because of undeclared milk.",6/14/2013,"06/14/2013",8/7/2013,"08/07/2013"
"Food",65465,"Ongoing","Oskri Corp.","Lake Mills","WI","US","Voluntary: Firm Initiated","Press Release","CA, CT, FL, ID, IL, IA, ME, MA, MI, MN, MO, MT, NV, NH, NJ, NY, NC, OH, OK, OR, PA, SD, TN, TX, VT, VA, WA, WV, WI.","F-1780-2013","Class I","OSKRI, Fig Dark Chocolate Bar, Net Wt 1.9 oz (53g) UPC 6 66016 30030 7. Ingredients: Figs 80%, dark chocolate 20% ( sugar, cocoa butter, pure chocolate, soy lecithin, natural vanilla). ","P 1/1/13 to 6/6/13. EXP 7/7/14 to 12/12/14. LOT 001 to 164.",,"2,138 cases","OSKRI Corp is recalling Coconut Bar Dark Chocolate, Coconut Bar Dark Chocolate Minis, Fig Dark Chocolate Bars and Almond Dark Chocolate Bars because of undeclared milk.",6/14/2013,"06/14/2013",8/7/2013,"08/07/2013"
"Food",65465,"Ongoing","Oskri Corp.","Lake Mills","WI","US","Voluntary: Firm Initiated","Press Release","CA, CT, FL, ID, IL, IA, ME, MA, MI, MN, MO, MT, NV, NH, NJ, NY, NC, OH, OK, OR, PA, SD, TN, TX, VT, VA, WA, WV, WI.","F-1781-2013","Class I","OSKRI, Almond Dark Chocolate Bars, Net Wt 1.9 oz (53g), UPC 6 66016 30042 0. Ingredients: Almonds 32%, Rice syrup, Rice Crisp, Dark Chocolate 10% ( sugar, chocolate liquor, coco butter, soy lecithin, natural vanilla).","P 1/1/13 to 6/6/13. EXP 7/7/14 to 12/12/14. LOT 001 to 154.",,"897 cases","OSKRI Corp is recalling Coconut Bar Dark Chocolate, Coconut Bar Dark Chocolate Minis, Fig Dark Chocolate Bars and Almond Dark Chocolate Bars because of undeclared milk.",6/14/2013,"06/14/2013",8/7/2013,"08/07/2013"
"Biologics",65466,"Ongoing","BD Biosciences, Systems & Reagents","San Jose","CA","US","Voluntary: Firm Initiated","Letter","Worldwide distribution.","B-2098-13","Class II","BDTM Stem Cell Control Kit; BD Biosciences 2350 Qume Drive, San Jose, CA 95131 ","Catalog number: 340991 Lot numbers: BC053, expires 06/02/13 and BC063, expires 07/02/13.",,"2 Units","BD Stem cells controls, not functioning as intended, were distributed. ",6/12/2013,"06/12/2013",7/31/2013,"07/31/2013"
"Drugs",65467,"Ongoing","Boehringer Ingelheim Roxane Inc","Columbus","OH","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Nationwide","D-882-2013","Class III","Prednisone Tablet USP, 20 mg tablets, packaged in blisters of ten (10) tablets per blister card, ten blister cards per carton, Roxanne, Columbus, OH --- NDC 0054-0018-20 ","The affected product consists of lot #261739A, expiration date OCT 2014. ",,"14,619 cartons","Labeling: Missing Label; missing label on blister card ",6/14/2013,"06/14/2013",8/21/2013,"08/21/2013"
"Devices",65468,"Ongoing","Philips Healthcare Inc.","Andover","MA","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution - USA (nationwide) and countries of: AFGHANISTAN ALBANIA ARGENTINA ARUBA AUSTRALIA AUSTRIA AZERBAIJAN BAHRAIN BANGLADESH BELGIUM BOLIVIA BOSNIA AND HERZEGOWINA BRAZIL BRUNEI DARUSSALAM BULGARIA CAMBODIA CHILE CHINA COLOMBIA COSTA RICA CROATIA (local name: Hrvatska) CYPRUS CZECH REPUBLIC DENMARK ECUADOR EGYPT EL SALVADOR ESTONIA ETHIOPIA FINLAND FRANCE GERMANY GREECE GUADELOUPE HONG KONG ICELAND INDIA INDONESIA IRAQ IRELAND ISRAEL ITALY JAPAN JORDAN KAZAKHSTAN KENYA KOREA, REPUBLIC OF KUWAIT LAOS LATVIA LEBANON LIBYAN ARAB JAMAHIRIYA LITHUANIA LUXEMBOURG MACAU MACEDONIA MALAYSIA MALTA MEXICO MONGOLIA MOROCCO NAMIBIA NEPAL NETHERLANDS NETHERLANDS ANTILLES NEW CALEDONIA NEW ZEALAND NICARAGUA NIGERIA NORWAY OMAN PAKISTAN PALESTINE PANAMA PAPUA NEW GUINEA PARAGUAY PERU PHILIPPINES POLAND PORTUGAL PUERTO RICO QATAR REUNION ROMANIA RUSSIAN FEDERATION SAUDI ARABIA SERBIA SINGAPORE SLOVENIA SOUTH AFRICA SPAIN SRI LANKA SWEDEN SWITZERLAND TAIWAN, PROVINCE OF CHINA TANZANIA, UNITED REPUBLIC OF THAILAND TRINIDAD AND TOBAGO TUNISIA TURKEY UGANDA UKRAINE UNITED ARAB EMIRATES UNITED KINGDOM UZBEKISTAN VENEZUELA VIET NAM and YEMEN.","Z-1797-2013","Class II","Philips HeartStart MRx Monitor/Defibrillator, Model numbers M3535A, M3536A, M3536J, M3536M, M3536MC, M3536M2, M3536M4, M3536M5, M3536M6 The device is for use by qualified medical personnel trained in the operation of the device and qualified by training in basic life support, advanced cardiac support, or defibrillation. It must be used by or on the order of a physician","Serial numbers ranging from: US00100100 to US00567299 (serial numbers of the HeartStart MRx monitor/defibrillator are printed on the primary label on the back of the MRx in battery bay B) ",,"66,150 units","The MRx may deliver a non-synchronized cardioversion shock resulting in the delivery of incorrect therapy, which may induce ventricular fibrillation. ",6/19/2013,"06/19/2013",7/31/2013,"07/31/2013"
"Devices",65469,"Ongoing","Carestream Health, Inc.","Rochester","NY","US","Voluntary: Firm Initiated","Letter","Nationwide Distribution including the states of NY, TX, PA, OH, WI, CA, IL, CO, FL, IN, OK, NJ, GA, LA, AL, KS, AZ, MA, SC, MI, NC, IA, UT, VA, TN, and MN.","Z-0126-2014","Class II","Carestream DRX-Revolution Mobile X-ray System. Produces radiographic images.","Serial Numbers: 111, 114, 119-123, 125-126, 134, 142-143, 151-155, 161-169, 173-178,180-183, 188-192, 196-209, 211, 221-232, 235-249, 254, 261-270, 275-276, 279-286, 305, 312, 316-326, 330-337, 339-349, 353, 355, 357-365, 372-373, 375-376, 379-385, 387-388, 394-401, 403-405, 409-410, 412-415, 417, 420-421, 423, 431-435, 441-446, 451-461, 464-470, and 482-490",,"180 units","Carestream Health Inc. is recalling the power plug on their DRX-Revolution Mobile X-Ray System due to the item generating sparks and becoming warm to touch. ",6/6/2013,"06/06/2013",11/6/2013,"11/06/2013"
"Devices",65470,"Ongoing","Biomerieux Inc","Hazelwood","MO","US","Voluntary: Firm Initiated","Letter","Worldwide distribution: US (nationwide) and countries of: Argentina, Australia, Austria, Bahrain, Belarus, Benelux, Brazil, Bulgaria, Canada, Chile China, Costa Rica, Croatia, Czech Republic, Dominican Republic, Dutch Antilles, Ecuador, Egypt, France, Germany, Hong Kong, Hungary, India, Indonesia, Israel, Italy, Japan, Kazakhstan, Korea, Kuwait, Libya, Lithuania, Macedonia, Malaysia, Malta, Mexico, Morocco, Myanmar, Netherlands, Nicaragua, Nigeria, Pakistan, Panama, Peru, Philippines, Poland, Portugal, Romania, Russia, Serbia, Singapore, Slovenia, Spain, Sweden, Switzerland, South Africa, Thailand, Tunisia, United Arab Emirates, United Kingdom, Uruguay, and Vietnam.","Z-1910-2013","Class II","bioMerieux Vitek 2 Systems Software version 6.01 software, used with the VITEK 2 automated system. Kit, UPDT V2S 6.01 DE. Part number: 414539. The product is used with the VITEK 2 automated system which consists of instruments, software and reagent cards designed for the identification and antimicrobial susceptibility testing of bacteria and yeast. ","version 6.01",".","12,384 total kits","A product issue has been identified for customers using software version 6.01 and are interfaced with a Laboratory Information System (LIS). During the update of software from version 5.xx to 6.01, the Bid-directional Computer interface (BCI) antibiotic codes are not updated properly for Cefovecin, Prulifloxacin and Ceftaroline. For the referenced antibiotics, the firm code in the reference table does not match the default host code in version 6.01 software.",6/14/2013,"06/14/2013",8/14/2013,"08/14/2013"
"Devices",65470,"Ongoing","Biomerieux Inc","Hazelwood","MO","US","Voluntary: Firm Initiated","Letter","Worldwide distribution: US (nationwide) and countries of: Argentina, Australia, Austria, Bahrain, Belarus, Benelux, Brazil, Bulgaria, Canada, Chile China, Costa Rica, Croatia, Czech Republic, Dominican Republic, Dutch Antilles, Ecuador, Egypt, France, Germany, Hong Kong, Hungary, India, Indonesia, Israel, Italy, Japan, Kazakhstan, Korea, Kuwait, Libya, Lithuania, Macedonia, Malaysia, Malta, Mexico, Morocco, Myanmar, Netherlands, Nicaragua, Nigeria, Pakistan, Panama, Peru, Philippines, Poland, Portugal, Romania, Russia, Serbia, Singapore, Slovenia, Spain, Sweden, Switzerland, South Africa, Thailand, Tunisia, United Arab Emirates, United Kingdom, Uruguay, and Vietnam.","Z-1919-2013","Class II","bioMerieux Vitek 2 Systems Software version 6.01 software, used with the VITEK 2 automated system. Kit, UPDT V2S 6.01 EL, TR. Part number: 414568. The product is used with the VITEK 2 automated system which consists of instruments, software and reagent cards designed for the identification and antimicrobial susceptibility testing of bacteria and yeast. ","version 6.01",".","12,384 total kits","A product issue has been identified for customers using software version 6.01 and are interfaced with a Laboratory Information System (LIS). During the update of software from version 5.xx to 6.01, the Bid-directional Computer interface (BCI) antibiotic codes are not updated properly for Cefovecin, Prulifloxacin and Ceftaroline. For the referenced antibiotics, the firm code in the reference table does not match the default host code in version 6.01 software.",6/14/2013,"06/14/2013",8/14/2013,"08/14/2013"
"Devices",65470,"Ongoing","Biomerieux Inc","Hazelwood","MO","US","Voluntary: Firm Initiated","Letter","Worldwide distribution: US (nationwide) and countries of: Argentina, Australia, Austria, Bahrain, Belarus, Benelux, Brazil, Bulgaria, Canada, Chile China, Costa Rica, Croatia, Czech Republic, Dominican Republic, Dutch Antilles, Ecuador, Egypt, France, Germany, Hong Kong, Hungary, India, Indonesia, Israel, Italy, Japan, Kazakhstan, Korea, Kuwait, Libya, Lithuania, Macedonia, Malaysia, Malta, Mexico, Morocco, Myanmar, Netherlands, Nicaragua, Nigeria, Pakistan, Panama, Peru, Philippines, Poland, Portugal, Romania, Russia, Serbia, Singapore, Slovenia, Spain, Sweden, Switzerland, South Africa, Thailand, Tunisia, United Arab Emirates, United Kingdom, Uruguay, and Vietnam.","Z-1913-2013","Class II","bioMerieux Vitek 2 Systems Software version 6.01 software, used with the VITEK 2 automated system. Kit, UPDT V2S 6.01 FR. Part number: 414562. The product is used with the VITEK 2 automated system which consists of instruments, software and reagent cards designed for the identification and antimicrobial susceptibility testing of bacteria and yeast. ","version 6.01",".","12,384 total kits","A product issue has been identified for customers using software version 6.01 and are interfaced with a Laboratory Information System (LIS). During the update of software from version 5.xx to 6.01, the Bid-directional Computer interface (BCI) antibiotic codes are not updated properly for Cefovecin, Prulifloxacin and Ceftaroline. For the referenced antibiotics, the firm code in the reference table does not match the default host code in version 6.01 software.",6/14/2013,"06/14/2013",8/14/2013,"08/14/2013"
"Devices",65470,"Ongoing","Biomerieux Inc","Hazelwood","MO","US","Voluntary: Firm Initiated","Letter","Worldwide distribution: US (nationwide) and countries of: Argentina, Australia, Austria, Bahrain, Belarus, Benelux, Brazil, Bulgaria, Canada, Chile China, Costa Rica, Croatia, Czech Republic, Dominican Republic, Dutch Antilles, Ecuador, Egypt, France, Germany, Hong Kong, Hungary, India, Indonesia, Israel, Italy, Japan, Kazakhstan, Korea, Kuwait, Libya, Lithuania, Macedonia, Malaysia, Malta, Mexico, Morocco, Myanmar, Netherlands, Nicaragua, Nigeria, Pakistan, Panama, Peru, Philippines, Poland, Portugal, Romania, Russia, Serbia, Singapore, Slovenia, Spain, Sweden, Switzerland, South Africa, Thailand, Tunisia, United Arab Emirates, United Kingdom, Uruguay, and Vietnam.","Z-1916-2013","Class II","bioMerieux Vitek 2 Systems Software version 6.01 software, used with the VITEK 2 automated system. Kit, UPDT V2S 6.01 NO. Part number: 414565. The product is used with the VITEK 2 automated system which consists of instruments, software and reagent cards designed for the identification and antimicrobial susceptibility testing of bacteria and yeast. ","version 6.01",".","12,384 total kits","A product issue has been identified for customers using software version 6.01 and are interfaced with a Laboratory Information System (LIS). During the update of software from version 5.xx to 6.01, the Bid-directional Computer interface (BCI) antibiotic codes are not updated properly for Cefovecin, Prulifloxacin and Ceftaroline. For the referenced antibiotics, the firm code in the reference table does not match the default host code in version 6.01 software.",6/14/2013,"06/14/2013",8/14/2013,"08/14/2013"
"Devices",65470,"Ongoing","Biomerieux Inc","Hazelwood","MO","US","Voluntary: Firm Initiated","Letter","Worldwide distribution: US (nationwide) and countries of: Argentina, Australia, Austria, Bahrain, Belarus, Benelux, Brazil, Bulgaria, Canada, Chile China, Costa Rica, Croatia, Czech Republic, Dominican Republic, Dutch Antilles, Ecuador, Egypt, France, Germany, Hong Kong, Hungary, India, Indonesia, Israel, Italy, Japan, Kazakhstan, Korea, Kuwait, Libya, Lithuania, Macedonia, Malaysia, Malta, Mexico, Morocco, Myanmar, Netherlands, Nicaragua, Nigeria, Pakistan, Panama, Peru, Philippines, Poland, Portugal, Romania, Russia, Serbia, Singapore, Slovenia, Spain, Sweden, Switzerland, South Africa, Thailand, Tunisia, United Arab Emirates, United Kingdom, Uruguay, and Vietnam.","Z-1908-2013","Class II","bioMerieux Vitek 2 Systems Software version 6.01 software, used with the VITEK 2 automated system. Kit, UPDT V2S 6.01ML1. Part number: 414537. The product is used with the VITEK 2 automated system which consists of instruments, software and reagent cards designed for the identification and antimicrobial susceptibility testing of bacteria and yeast. ","version 6.01",".","12,384 total kits","A product issue has been identified for customers using software version 6.01 and are interfaced with a Laboratory Information System (LIS). During the update of software from version 5.xx to 6.01, the Bid-directional Computer interface (BCI) antibiotic codes are not updated properly for Cefovecin, Prulifloxacin and Ceftaroline. For the referenced antibiotics, the firm code in the reference table does not match the default host code in version 6.01 software.",6/14/2013,"06/14/2013",8/14/2013,"08/14/2013"
"Devices",65470,"Ongoing","Biomerieux Inc","Hazelwood","MO","US","Voluntary: Firm Initiated","Letter","Worldwide distribution: US (nationwide) and countries of: Argentina, Australia, Austria, Bahrain, Belarus, Benelux, Brazil, Bulgaria, Canada, Chile China, Costa Rica, Croatia, Czech Republic, Dominican Republic, Dutch Antilles, Ecuador, Egypt, France, Germany, Hong Kong, Hungary, India, Indonesia, Israel, Italy, Japan, Kazakhstan, Korea, Kuwait, Libya, Lithuania, Macedonia, Malaysia, Malta, Mexico, Morocco, Myanmar, Netherlands, Nicaragua, Nigeria, Pakistan, Panama, Peru, Philippines, Poland, Portugal, Romania, Russia, Serbia, Singapore, Slovenia, Spain, Sweden, Switzerland, South Africa, Thailand, Tunisia, United Arab Emirates, United Kingdom, Uruguay, and Vietnam.","Z-1911-2013","Class II","bioMerieux Vitek 2 Systems Software version 6.01 software, used with the VITEK 2 automated system. Kit, UPDT V2S 6.01 EN. Part number: 414560. The product is used with the VITEK 2 automated system which consists of instruments, software and reagent cards designed for the identification and antimicrobial susceptibility testing of bacteria and yeast. ","version 6.01",".","12,384 total kits","A product issue has been identified for customers using software version 6.01 and are interfaced with a Laboratory Information System (LIS). During the update of software from version 5.xx to 6.01, the Bid-directional Computer interface (BCI) antibiotic codes are not updated properly for Cefovecin, Prulifloxacin and Ceftaroline. For the referenced antibiotics, the firm code in the reference table does not match the default host code in version 6.01 software.",6/14/2013,"06/14/2013",8/14/2013,"08/14/2013"
"Devices",65470,"Ongoing","Biomerieux Inc","Hazelwood","MO","US","Voluntary: Firm Initiated","Letter","Worldwide distribution: US (nationwide) and countries of: Argentina, Australia, Austria, Bahrain, Belarus, Benelux, Brazil, Bulgaria, Canada, Chile China, Costa Rica, Croatia, Czech Republic, Dominican Republic, Dutch Antilles, Ecuador, Egypt, France, Germany, Hong Kong, Hungary, India, Indonesia, Israel, Italy, Japan, Kazakhstan, Korea, Kuwait, Libya, Lithuania, Macedonia, Malaysia, Malta, Mexico, Morocco, Myanmar, Netherlands, Nicaragua, Nigeria, Pakistan, Panama, Peru, Philippines, Poland, Portugal, Romania, Russia, Serbia, Singapore, Slovenia, Spain, Sweden, Switzerland, South Africa, Thailand, Tunisia, United Arab Emirates, United Kingdom, Uruguay, and Vietnam.","Z-1907-2013","Class II","bioMerieux Vitek 2 Systems Software version 6.01 software, used with the VITEK 2 automated system. Kit, V2S 6.01 RP5800-WES7 Media. Part number: 413861. The product is used with the VITEK 2 automated system which consists of instruments, software and reagent cards designed for the identification and antimicrobial susceptibility testing of bacteria and yeast. ","version 6.01",".","12,384 total kits","A product issue has been identified for customers using software version 6.01 and are interfaced with a Laboratory Information System (LIS). During the update of software from version 5.xx to 6.01, the Bid-directional Computer interface (BCI) antibiotic codes are not updated properly for Cefovecin, Prulifloxacin and Ceftaroline. For the referenced antibiotics, the firm code in the reference table does not match the default host code in version 6.01 software.",6/14/2013,"06/14/2013",8/14/2013,"08/14/2013"
"Devices",65470,"Ongoing","Biomerieux Inc","Hazelwood","MO","US","Voluntary: Firm Initiated","Letter","Worldwide distribution: US (nationwide) and countries of: Argentina, Australia, Austria, Bahrain, Belarus, Benelux, Brazil, Bulgaria, Canada, Chile China, Costa Rica, Croatia, Czech Republic, Dominican Republic, Dutch Antilles, Ecuador, Egypt, France, Germany, Hong Kong, Hungary, India, Indonesia, Israel, Italy, Japan, Kazakhstan, Korea, Kuwait, Libya, Lithuania, Macedonia, Malaysia, Malta, Mexico, Morocco, Myanmar, Netherlands, Nicaragua, Nigeria, Pakistan, Panama, Peru, Philippines, Poland, Portugal, Romania, Russia, Serbia, Singapore, Slovenia, Spain, Sweden, Switzerland, South Africa, Thailand, Tunisia, United Arab Emirates, United Kingdom, Uruguay, and Vietnam.","Z-1914-2013","Class II","bioMerieux Vitek 2 Systems Software version 6.01 software, used with the VITEK 2 automated system. Kit, UPDT V2S 6.01 IT. Part number: 414563. The product is used with the VITEK 2 automated system which consists of instruments, software and reagent cards designed for the identification and antimicrobial susceptibility testing of bacteria and yeast. ","version 6.01",".","12,384 total kits","A product issue has been identified for customers using software version 6.01 and are interfaced with a Laboratory Information System (LIS). During the update of software from version 5.xx to 6.01, the Bid-directional Computer interface (BCI) antibiotic codes are not updated properly for Cefovecin, Prulifloxacin and Ceftaroline. For the referenced antibiotics, the firm code in the reference table does not match the default host code in version 6.01 software.",6/14/2013,"06/14/2013",8/14/2013,"08/14/2013"
"Devices",65470,"Ongoing","Biomerieux Inc","Hazelwood","MO","US","Voluntary: Firm Initiated","Letter","Worldwide distribution: US (nationwide) and countries of: Argentina, Australia, Austria, Bahrain, Belarus, Benelux, Brazil, Bulgaria, Canada, Chile China, Costa Rica, Croatia, Czech Republic, Dominican Republic, Dutch Antilles, Ecuador, Egypt, France, Germany, Hong Kong, Hungary, India, Indonesia, Israel, Italy, Japan, Kazakhstan, Korea, Kuwait, Libya, Lithuania, Macedonia, Malaysia, Malta, Mexico, Morocco, Myanmar, Netherlands, Nicaragua, Nigeria, Pakistan, Panama, Peru, Philippines, Poland, Portugal, Romania, Russia, Serbia, Singapore, Slovenia, Spain, Sweden, Switzerland, South Africa, Thailand, Tunisia, United Arab Emirates, United Kingdom, Uruguay, and Vietnam.","Z-1918-2013","Class II","bioMerieux Vitek 2 Systems Software version 6.01 software, used with the VITEK 2 automated system. Kit, UPDT V2S 6.01 DA, SV. Part number: 414567. The product is used with the VITEK 2 automated system which consists of instruments, software and reagent cards designed for the identification and antimicrobial susceptibility testing of bacteria and yeast. ","version 6.01",".","12,384 total kits","A product issue has been identified for customers using software version 6.01 and are interfaced with a Laboratory Information System (LIS). During the update of software from version 5.xx to 6.01, the Bid-directional Computer interface (BCI) antibiotic codes are not updated properly for Cefovecin, Prulifloxacin and Ceftaroline. For the referenced antibiotics, the firm code in the reference table does not match the default host code in version 6.01 software.",6/14/2013,"06/14/2013",8/14/2013,"08/14/2013"
"Devices",65470,"Ongoing","Biomerieux Inc","Hazelwood","MO","US","Voluntary: Firm Initiated","Letter","Worldwide distribution: US (nationwide) and countries of: Argentina, Australia, Austria, Bahrain, Belarus, Benelux, Brazil, Bulgaria, Canada, Chile China, Costa Rica, Croatia, Czech Republic, Dominican Republic, Dutch Antilles, Ecuador, Egypt, France, Germany, Hong Kong, Hungary, India, Indonesia, Israel, Italy, Japan, Kazakhstan, Korea, Kuwait, Libya, Lithuania, Macedonia, Malaysia, Malta, Mexico, Morocco, Myanmar, Netherlands, Nicaragua, Nigeria, Pakistan, Panama, Peru, Philippines, Poland, Portugal, Romania, Russia, Serbia, Singapore, Slovenia, Spain, Sweden, Switzerland, South Africa, Thailand, Tunisia, United Arab Emirates, United Kingdom, Uruguay, and Vietnam.","Z-1921-2013","Class II","bioMerieux Vitek 2 Systems Software version 6.01 software, used with the VITEK 2 automated system. Kit V2S RP5800XPE TO 6.01 WES7. Part number: 6201773. The product is used with the VITEK 2 automated system which consists of instruments, software and reagent cards designed for the identification and antimicrobial susceptibility testing of bacteria and yeast. ","version 6.01",".","12,384 total kits","A product issue has been identified for customers using software version 6.01 and are interfaced with a Laboratory Information System (LIS). During the update of software from version 5.xx to 6.01, the Bid-directional Computer interface (BCI) antibiotic codes are not updated properly for Cefovecin, Prulifloxacin and Ceftaroline. For the referenced antibiotics, the firm code in the reference table does not match the default host code in version 6.01 software.",6/14/2013,"06/14/2013",8/14/2013,"08/14/2013"
"Devices",65470,"Ongoing","Biomerieux Inc","Hazelwood","MO","US","Voluntary: Firm Initiated","Letter","Worldwide distribution: US (nationwide) and countries of: Argentina, Australia, Austria, Bahrain, Belarus, Benelux, Brazil, Bulgaria, Canada, Chile China, Costa Rica, Croatia, Czech Republic, Dominican Republic, Dutch Antilles, Ecuador, Egypt, France, Germany, Hong Kong, Hungary, India, Indonesia, Israel, Italy, Japan, Kazakhstan, Korea, Kuwait, Libya, Lithuania, Macedonia, Malaysia, Malta, Mexico, Morocco, Myanmar, Netherlands, Nicaragua, Nigeria, Pakistan, Panama, Peru, Philippines, Poland, Portugal, Romania, Russia, Serbia, Singapore, Slovenia, Spain, Sweden, Switzerland, South Africa, Thailand, Tunisia, United Arab Emirates, United Kingdom, Uruguay, and Vietnam.","Z-1909-2013","Class II","bioMerieux Vitek 2 Systems Software version 6.01 software, used with the VITEK 2 automated system. Kit, UPDT V2S 6.01ML2. Part number: 414538. The product is used with the VITEK 2 automated system which consists of instruments, software and reagent cards designed for the identification and antimicrobial susceptibility testing of bacteria and yeast. ","version 6.01",".","12,384 total kits","A product issue has been identified for customers using software version 6.01 and are interfaced with a Laboratory Information System (LIS). During the update of software from version 5.xx to 6.01, the Bid-directional Computer interface (BCI) antibiotic codes are not updated properly for Cefovecin, Prulifloxacin and Ceftaroline. For the referenced antibiotics, the firm code in the reference table does not match the default host code in version 6.01 software.",6/14/2013,"06/14/2013",8/14/2013,"08/14/2013"
"Devices",65470,"Ongoing","Biomerieux Inc","Hazelwood","MO","US","Voluntary: Firm Initiated","Letter","Worldwide distribution: US (nationwide) and countries of: Argentina, Australia, Austria, Bahrain, Belarus, Benelux, Brazil, Bulgaria, Canada, Chile China, Costa Rica, Croatia, Czech Republic, Dominican Republic, Dutch Antilles, Ecuador, Egypt, France, Germany, Hong Kong, Hungary, India, Indonesia, Israel, Italy, Japan, Kazakhstan, Korea, Kuwait, Libya, Lithuania, Macedonia, Malaysia, Malta, Mexico, Morocco, Myanmar, Netherlands, Nicaragua, Nigeria, Pakistan, Panama, Peru, Philippines, Poland, Portugal, Romania, Russia, Serbia, Singapore, Slovenia, Spain, Sweden, Switzerland, South Africa, Thailand, Tunisia, United Arab Emirates, United Kingdom, Uruguay, and Vietnam.","Z-1912-2013","Class II","bioMerieux Vitek 2 Systems Software version 6.01 software, used with the VITEK 2 automated system. Kit, UPDT V2S 6.01 ES. Part number: 414561. The product is used with the VITEK 2 automated system which consists of instruments, software and reagent cards designed for the identification and antimicrobial susceptibility testing of bacteria and yeast. ","version 6.01",".","12,384 total kits","A product issue has been identified for customers using software version 6.01 and are interfaced with a Laboratory Information System (LIS). During the update of software from version 5.xx to 6.01, the Bid-directional Computer interface (BCI) antibiotic codes are not updated properly for Cefovecin, Prulifloxacin and Ceftaroline. For the referenced antibiotics, the firm code in the reference table does not match the default host code in version 6.01 software.",6/14/2013,"06/14/2013",8/14/2013,"08/14/2013"
"Devices",65470,"Ongoing","Biomerieux Inc","Hazelwood","MO","US","Voluntary: Firm Initiated","Letter","Worldwide distribution: US (nationwide) and countries of: Argentina, Australia, Austria, Bahrain, Belarus, Benelux, Brazil, Bulgaria, Canada, Chile China, Costa Rica, Croatia, Czech Republic, Dominican Republic, Dutch Antilles, Ecuador, Egypt, France, Germany, Hong Kong, Hungary, India, Indonesia, Israel, Italy, Japan, Kazakhstan, Korea, Kuwait, Libya, Lithuania, Macedonia, Malaysia, Malta, Mexico, Morocco, Myanmar, Netherlands, Nicaragua, Nigeria, Pakistan, Panama, Peru, Philippines, Poland, Portugal, Romania, Russia, Serbia, Singapore, Slovenia, Spain, Sweden, Switzerland, South Africa, Thailand, Tunisia, United Arab Emirates, United Kingdom, Uruguay, and Vietnam.","Z-1915-2013","Class II","bioMerieux Vitek 2 Systems Software version 6.01 software, used with the VITEK 2 automated system. Kit, UPDT V2S 6.01 JA. Part number: 414564. The product is used with the VITEK 2 automated system which consists of instruments, software and reagent cards designed for the identification and antimicrobial susceptibility testing of bacteria and yeast. ","version 6.01",".","12,384 total kits","A product issue has been identified for customers using software version 6.01 and are interfaced with a Laboratory Information System (LIS). During the update of software from version 5.xx to 6.01, the Bid-directional Computer interface (BCI) antibiotic codes are not updated properly for Cefovecin, Prulifloxacin and Ceftaroline. For the referenced antibiotics, the firm code in the reference table does not match the default host code in version 6.01 software.",6/14/2013,"06/14/2013",8/14/2013,"08/14/2013"
"Devices",65470,"Ongoing","Biomerieux Inc","Hazelwood","MO","US","Voluntary: Firm Initiated","Letter","Worldwide distribution: US (nationwide) and countries of: Argentina, Australia, Austria, Bahrain, Belarus, Benelux, Brazil, Bulgaria, Canada, Chile China, Costa Rica, Croatia, Czech Republic, Dominican Republic, Dutch Antilles, Ecuador, Egypt, France, Germany, Hong Kong, Hungary, India, Indonesia, Israel, Italy, Japan, Kazakhstan, Korea, Kuwait, Libya, Lithuania, Macedonia, Malaysia, Malta, Mexico, Morocco, Myanmar, Netherlands, Nicaragua, Nigeria, Pakistan, Panama, Peru, Philippines, Poland, Portugal, Romania, Russia, Serbia, Singapore, Slovenia, Spain, Sweden, Switzerland, South Africa, Thailand, Tunisia, United Arab Emirates, United Kingdom, Uruguay, and Vietnam.","Z-1917-2013","Class II","bioMerieux Vitek 2 Systems Software version 6.01 software, used with the VITEK 2 automated system. Kit, UPDT V2S 6.01 PT. Part number: 414566. The product is used with the VITEK 2 automated system which consists of instruments, software and reagent cards designed for the identification and antimicrobial susceptibility testing of bacteria and yeast. ","version 6.01",".","12,384 total kits","A product issue has been identified for customers using software version 6.01 and are interfaced with a Laboratory Information System (LIS). During the update of software from version 5.xx to 6.01, the Bid-directional Computer interface (BCI) antibiotic codes are not updated properly for Cefovecin, Prulifloxacin and Ceftaroline. For the referenced antibiotics, the firm code in the reference table does not match the default host code in version 6.01 software.",6/14/2013,"06/14/2013",8/14/2013,"08/14/2013"
"Devices",65470,"Ongoing","Biomerieux Inc","Hazelwood","MO","US","Voluntary: Firm Initiated","Letter","Worldwide distribution: US (nationwide) and countries of: Argentina, Australia, Austria, Bahrain, Belarus, Benelux, Brazil, Bulgaria, Canada, Chile China, Costa Rica, Croatia, Czech Republic, Dominican Republic, Dutch Antilles, Ecuador, Egypt, France, Germany, Hong Kong, Hungary, India, Indonesia, Israel, Italy, Japan, Kazakhstan, Korea, Kuwait, Libya, Lithuania, Macedonia, Malaysia, Malta, Mexico, Morocco, Myanmar, Netherlands, Nicaragua, Nigeria, Pakistan, Panama, Peru, Philippines, Poland, Portugal, Romania, Russia, Serbia, Singapore, Slovenia, Spain, Sweden, Switzerland, South Africa, Thailand, Tunisia, United Arab Emirates, United Kingdom, Uruguay, and Vietnam.","Z-1920-2013","Class II","bioMerieux Vitek 2 Systems Software version 6.01 software, used with the VITEK 2 automated system. Kit, UPDT V2S 6.01 ZH. Part number: 414569. The product is used with the VITEK 2 automated system which consists of instruments, software and reagent cards designed for the identification and antimicrobial susceptibility testing of bacteria and yeast. ","version 6.01",".","12,384 total kits","A product issue has been identified for customers using software version 6.01 and are interfaced with a Laboratory Information System (LIS). During the update of software from version 5.xx to 6.01, the Bid-directional Computer interface (BCI) antibiotic codes are not updated properly for Cefovecin, Prulifloxacin and Ceftaroline. For the referenced antibiotics, the firm code in the reference table does not match the default host code in version 6.01 software.",6/14/2013,"06/14/2013",8/14/2013,"08/14/2013"
"Devices",65471,"Ongoing","GE Healthcare It","Barrington","IL","US","Voluntary: Firm Initiated","Letter"," Worldwide Distribution: US (nationwide) including states of: AK, AL, AR, AZ, CA, CO, CT, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, NH, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI and WV) and the countries of the UK, Taiwan, Switerzland, Sweden, Spain, Singapore, Saudi Arabia, Netherlands, Malaysia, Korea, Japan, Italy, Israel, India, Hong Kong, Germany, France, Denmark, China, Canada, Bermuda, Beligum and Australia","Z-0116-2014","Class II","The Centricity PACS Workstation is intended for use as a primary diagnostic and analysis tool for diagnostic images by trained healthcare professionals, including radiologists, physicians, technologists, clinicians and nurses. It is also intended for use as a clinical review workstation throughout the healthcare facility. The workstation interface provides the user with a means to display, manipulate, archive, print and export images when connected with the Centricity PACS infrastructure. ","GE Centricity PACS Versions: 3.1.1.2, 3.2, 3.2.0.1, 3.2.0.2, 3.2.1, 3.2.2, 3.2.2.1, 3.2.2.2, 3.2.2.3, 3.2.6, 4.0, 4.0.1",,"623 units","GE has recently become aware of potential issues due to out of context issues associated with specific workflows of the Centricity PACS RA1000 workstation. These issues are as follows: 1) In Centricity RIS-IC, and a RIS-Driven integration, the ''close'' button closes the exam in RIS-IC, but does not close the exam in Centricity PACS RA1000 Workstation. 2) Interrupted workflow could break the synchronization between Nuance PowerScribe 360 and Centricity PACS RA1000 Workstation. 3) Interrupted workflow could break the synchronization between Agfa Talk and Centricity PACS RA1000 Workstation.",6/11/2013,"06/11/2013",11/6/2013,"11/06/2013"
"Devices",65472,"Ongoing","Ortho-Clinical Diagnostics","Rochester","NY","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution - USA Nationwide in the states of AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV, WY, including Puerto Rico and the countries of Mexico, Singapore, Venezuela, England, Germany, Italy & Spain.","Z-1948-2013","Class II","Colorimetric (CM)/ Rate (RT) incubator wear pads. Product Codes: 1) 6801375, 2) 6801890, 3) 6802445, 4) 6802413 Product Usage: The CM/RT incubator processes Microslide reagents with the following VITROS systems: 1) VITROS 5,1 FS Chemistry System, 2) VITROS 5,1 FS Chemistry System Refurbished, 3) VITROS 4600 Chemistry System (VITROS 5,1 FS System family member), VITROS 5600 Integrated System.","Serial Numbers: 1) J34000102 through J34002323, 2) 34000133, 34000193, 4000212, 34000316, 34000318, 34000337, 34000360, 34000420, 34000451, 34000478, 34000495, 34000497, 34000529, 34000538, 34000552, 34000557, 34000596, 34000601, 34000631, 34000642, 34000805, 34000833, 34000851, 34000893, 34000947, 34001172, 34001218, 34001240, 34001243, 34001248, 34001251, 34001274, 34001297, 34001311, 34001317, 34001345, 34001378, 34001389, 34001390, 34001396, 34001422, 34001472, 34001504, 34001569, 34001572, 34001589, 34001610, 34001612, 34001633, 34001668, 34001809, 34001840, 34001850, 34001897, 3) J46000108 through J46000312, 4) J56000110 through J56001779.",,,"Ortho Clinical Diagnostics is recalling CM/RT wear pads which are a component in the CM/RT incubator due to becoming worn before their replacement.",6/6/2013,"06/06/2013",8/21/2013,"08/21/2013"
"Devices",65473,"Ongoing","Steritec Products Mfc. Co., Inc.","Englewood","CO","US","Voluntary: Firm Initiated","Letter","Worldwide distribution: US (Nationwide) and countries of: Argentina, Australia, Canada, British Virgin Island, Czech Republic, Italy, and Turkey.","Z-1826-2013","Class II","Getinge Assure Accufast BI Test Pack w/ 25 Controls, SteriTec Product Code PL 395/25, Distributor Product Code 61301606639 The Smart-Read Biological Test Pack with Instant Readout Integrator: is designed specifically for biological testing of 3 or 4 minutes or longer at 132 (270 and 3 minutes at 135 pre-vacuum steam sterilizers.","Affected Biological Indicator Lot No.:121101-447 and 121101-444",,"15,300 units","Mesa Labs, based out of Bozeman, MT, informed SteriTec Products, Inc. of a product recall involving the EZTest Steam and Smart-Read Biological Indicators (BI) because the readout time is not in specification with the label claims. ",6/10/2013,"06/10/2013",8/7/2013,"08/07/2013"
"Devices",65473,"Ongoing","Steritec Products Mfc. Co., Inc.","Englewood","CO","US","Voluntary: Firm Initiated","Letter","Worldwide distribution: US (Nationwide) and countries of: Argentina, Australia, Canada, British Virgin Island, Czech Republic, Italy, and Turkey.","Z-1822-2013","Class II","Medline Steam Biological Indicators, SteriTec Product Code PL 353, Distributor Product Code MDS200525 EZTest Steam Biological Indicator: Mesa EZTest Steam Biological Indicator is a self contained Biological Indicator intended for monitoring the efficacy of 121C, 132C, 134C and 135C steam sterilization cycles. Mesa EZTest has a recommended incubation time of 24 hours. ","Affected Biological Indicator Lot No.: S-444",,"8200 units","Mesa Labs, based out of Bozeman, MT, informed SteriTec Products, Inc. of a product recall involving the EZTest Steam and Smart-Read Biological Indicators (BI) because the readout time is not in specification with the label claims. ",6/10/2013,"06/10/2013",8/7/2013,"08/07/2013"
"Devices",65473,"Ongoing","Steritec Products Mfc. Co., Inc.","Englewood","CO","US","Voluntary: Firm Initiated","Letter","Worldwide distribution: US (Nationwide) and countries of: Argentina, Australia, Canada, British Virgin Island, Czech Republic, Italy, and Turkey.","Z-1827-2013","Class II","Mesa Labs Smart-Read 10^5 EZ Test BI Test Pack, SteriTec Product Code PL 298/25, Distributor Product Code SRSP/25 The Smart-Read Biological Test Pack with Instant Readout Integrator: is designed specifically for biological testing of 3 or 4 minutes or longer at 1132 (27270 and 3 minutes at 11357275re-vacuum steam sterilizers.","Affected Biological Indicator Lot No.:130301",,"5000 units","Mesa Labs, based out of Bozeman, MT, informed SteriTec Products, Inc. of a product recall involving the EZTest Steam and Smart-Read Biological Indicators (BI) because the readout time is not in specification with the label claims. ",6/10/2013,"06/10/2013",8/7/2013,"08/07/2013"
"Devices",65473,"Ongoing","Steritec Products Mfc. Co., Inc.","Englewood","CO","US","Voluntary: Firm Initiated","Letter","Worldwide distribution: US (Nationwide) and countries of: Argentina, Australia, Canada, British Virgin Island, Czech Republic, Italy, and Turkey.","Z-1825-2013","Class II","Getinge Assure Accufast BI Test Pack w/ 5 Controls, SteriTec Product Code PL 395, Distributor Product Code 61301606638 The Smart-Read Biological Test Pack with Instant Readout Integrator: is designed specifically for biological testing of 3 or 4 minutes or longer at 132 (270 and 3 minutes at 135 pre-vacuum steam sterilizers. ","Affected Biological Indicator Lot No.:121101-447 and 121101-444",,"10,170 units","Mesa Labs, based out of Bozeman, MT, informed SteriTec Products, Inc. of a product recall involving the EZTest Steam and Smart-Read Biological Indicators (BI) because the readout time is not in specification with the label claims. ",6/10/2013,"06/10/2013",8/7/2013,"08/07/2013"
"Devices",65473,"Ongoing","Steritec Products Mfc. Co., Inc.","Englewood","CO","US","Voluntary: Firm Initiated","Letter","Worldwide distribution: US (Nationwide) and countries of: Argentina, Australia, Canada, British Virgin Island, Czech Republic, Italy, and Turkey.","Z-1823-2013","Class II","Cardinal Steam Biological Indicator, SteriTec Product Code PL 218, Distributor Product Code T40360EZ EZTest Steam Biological Indicator: Mesa EZTest Steam Biological Indicator is a self contained Biological Indicator intended for monitoring the efficacy of 121C, 132C, 134C and 135C steam sterilization cycles. Mesa EZTest has a recommended incubation time of 24 hours. ","Affected Biological Indicator Lot No.: S-444",,"200","Mesa Labs, based out of Bozeman, MT, informed SteriTec Products, Inc. of a product recall involving the EZTest Steam and Smart-Read Biological Indicators (BI) because the readout time is not in specification with the label claims. ",6/10/2013,"06/10/2013",8/7/2013,"08/07/2013"
"Devices",65473,"Ongoing","Steritec Products Mfc. Co., Inc.","Englewood","CO","US","Voluntary: Firm Initiated","Letter","Worldwide distribution: US (Nationwide) and countries of: Argentina, Australia, Canada, British Virgin Island, Czech Republic, Italy, and Turkey.","Z-1828-2013","Class II","Medline Med-Checks BI Test packs with Instant Readout Integrator, SteriTec Product Code PL 200, Distributor Product Code MDS200500IR SteriTec Steam Biological Test Packs with Instant Readout Integrator Card: The Steam Biological Test Pack with Instant Readout Integrator is a steam sterilization monitor designed specifically for biological testing of pre-vacuum steam sterilizers operating at 132C (270F) for 3 minutes or longer. The Instant Readout Integrator Card gives the operator a prediction of the biological test outcome","Affected Biological Indicator Lot No.:130401",,"3535 units","Mesa Labs, based out of Bozeman, MT, informed SteriTec Products, Inc. of a product recall involving the EZTest Steam and Smart-Read Biological Indicators (BI) because the readout time is not in specification with the label claims. ",6/10/2013,"06/10/2013",8/7/2013,"08/07/2013"
"Devices",65473,"Ongoing","Steritec Products Mfc. Co., Inc.","Englewood","CO","US","Voluntary: Firm Initiated","Letter","Worldwide distribution: US (Nationwide) and countries of: Argentina, Australia, Canada, British Virgin Island, Czech Republic, Italy, and Turkey.","Z-1829-2013","Class II","Cardinal BI Stat Biological Test Pack with Instant Readout Integrator, SteriTec Product Code PL 160/A, Distributor Product Code T40311PE SteriTec Steam Biological Test Packs with Instant Readout Integrator Card: The Steam Biological Test Pack with Instant Readout Integrator is a steam sterilization monitor designed specifically for biological testing of pre-vacuum steam sterilizers operating at 132C (270F) for 3 minutes or longer. The Instant Readout Integrator Card gives the operator a prediction of the biological test outcome. ","Affected Biological Indicator Lot No.:130401",,"360 units","Mesa Labs, based out of Bozeman, MT, informed SteriTec Products, Inc. of a product recall involving the EZTest Steam and Smart-Read Biological Indicators (BI) because the readout time is not in specification with the label claims. ",6/10/2013,"06/10/2013",8/7/2013,"08/07/2013"
"Devices",65473,"Ongoing","Steritec Products Mfc. Co., Inc.","Englewood","CO","US","Voluntary: Firm Initiated","Letter","Worldwide distribution: US (Nationwide) and countries of: Argentina, Australia, Canada, British Virgin Island, Czech Republic, Italy, and Turkey.","Z-1824-2013","Class II","EZTest Steam Biological Indicator, SteriTec Product Code EZS and EZS-400 EZTest Steam Biological Indicator: Mesa EZTest Steam Biological Indicator is a self contained Biological Indicator intended for monitoring the efficacy of 121C, 132C, 134C and 135C steam sterilization cycles. Mesa EZTest has a recommended incubation time of 24 hours. ","Affected Biological Indicator Lot No.: S-444",,"14,900 units","Mesa Labs, based out of Bozeman, MT, informed SteriTec Products, Inc. of a product recall involving the EZTest Steam and Smart-Read Biological Indicators (BI) because the readout time is not in specification with the label claims. ",6/10/2013,"06/10/2013",8/7/2013,"08/07/2013"
"Food",65474,"Ongoing","See's Candies Inc.","South San Francisco","CA","US","Voluntary: Firm Initiated","Press Release","240 stores and 10 See's licensees nationwide and 6 international retail stores.","F-1576-2013","Class I","See's Dark Raisins: Ingredients: Raisins, Sugar,chocolate, cocoa butter, butter (milk), vanilla, soy lecithin, Dextrin, Confectionery glaze. May contain traces of eggs, tree nuts and peanuts. Sold in Net Wt. 8 oz (227 g) clear plastic packages or purchased by customer at counter in See's Stores. UPC 7 37666 08305 3 Manufactured by: See's Candy Shops Incorporated So. San Francisco, CA 04080","All lots.",,"4,700 lb.","Potential for nuts and/or nut and egg residue may be present in some of the dark and milk chocolate covered raisins.",6/14/2013,"06/14/2013",7/3/2013,"07/03/2013"
"Food",65474,"Ongoing","See's Candies Inc.","South San Francisco","CA","US","Voluntary: Firm Initiated","Press Release","240 stores and 10 See's licensees nationwide and 6 international retail stores.","F-1575-2013","Class I","See's Milk Raisins: Ingredients: Raisins, Sugar, Cocoa butter, milk chocolate, soy lecithin, Vanillin, Dextrin, Confectionery glaze.May contain traces of eggs, tree nuts and peanuts Sold in Net Wt. 8 oz (227 g) clear plastic packages or purchased by customer at counter in See's Stores. UPC 7 37666 08306 0 Manufactured by: See's Candy Shops Incorporated So. San Francisco, CA 04080","All lots.",,"5,814 lb.","Potential for nuts and/or nut and egg residue may be present in some of the dark and milk chocolate covered raisins.",6/14/2013,"06/14/2013",7/3/2013,"07/03/2013"
"Devices",65476,"Completed","Remel Inc","Lenexa","KS","US","Voluntary: Firm Initiated","Letter","Nationwide Distribution","Z-0538-2014","Class II","Streptex* Latex D, Ref R30950901 ZL54, IVD, Latex reagent for streptococcal group D, 50 tests per box. The firm name on the label is Remel Inc., Lenexa, KS, Manufactured by Remel Europe Ltd., Dartford Kent, UK. Streptex is a rapid latex test system for use in the qualitative detection and identification of the Lancefield group of streptococci ","Lot 1149576, exp January 2014",".","109 kits","The product may give weak or false negative test results.",5/2/2013,"05/02/2013",12/26/2013,"12/26/2013"
"Devices",65476,"Completed","Remel Inc","Lenexa","KS","US","Voluntary: Firm Initiated","Letter","Nationwide Distribution","Z-0537-2014","Class II","Streptex* kit, Ref R30950501 ZL50, Rapid latex test for Streptococcal grouping, IVD. The kit contains reagent groups A, B, C, D, F, G, a control, and an extraction enzyme. The firm name on the label is Remel Europe Ltd., Dartford, England. Streptex is a rapid latex test system for use in the qualitative detection and identification of the Lancefield group of streptococci. Reagents are provided for groups A, B, C, D, F and G covering the majority of clinical isolates, group E streptococci are rarely isolated.","Lot 1192181, exp. January 2014",".","768 kits","The product may give weak or false negative test results.",5/2/2013,"05/02/2013",12/26/2013,"12/26/2013"
"Devices",65477,"Completed","Remel Inc","Lenexa","KS","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution - USA Nationwide in the states of AL, AZ, CA, CT, FL, ID, IN, KY, MA, MI, MS, NJ, OH, PA, TX, WI and the countries of Canada, UK, and Japan.","Z-0530-2014","Class II","remel RapID Yeast Plus System, 20 tests, Ref: R8311007, IVD, containing a 15-ml bottle of RapID Yeast Plus Reagent A and a 10-ml bottle of RapID Yeast Plus Reagent B. Product Usage: For the biochemical identification of medically important yeast and yeast-like organisms.","Lot 302532, Exp 6 Feb 2014",".","150 kits","The two reagents supplied in the RapID Yeast Plus System kit (Reagent A and Reagent B) are mislabeled. The labels were reversed.",4/4/2013,"04/04/2013",12/26/2013,"12/26/2013"
"Food",65478,"Ongoing","Middlefield Original Cheese Coop","Middlefield","OH","US","Voluntary: Firm Initiated","Telephone","The cheese was sold/distributed to Laubscher Cheese 1468 Perry Highway Mercer, PA 16137, contact is Kevin at 800-798-4015; the liquid whey was sold/distributed to Miceli's Cheese 2721 E. 90th St Cleveland, Ohio 44104, contact is Cominick at 800-551-7196 Ext. 125.","F-1553-2013","Class II","Whey liquid packaged in unknown containers. ","None; the liquid whey is stored in silos and pumped into tankers for shipping. The firm only tracks the volume that is being distributed. ",".","90,100 gallons of sweet whey. ","The raw milk used to manufacture whey was not tested for the concentration of Beta Lactam antibiotics, which are allergens. ",6/13/2013,"06/13/2013",7/10/2013,"07/10/2013"
"Food",65478,"Ongoing","Middlefield Original Cheese Coop","Middlefield","OH","US","Voluntary: Firm Initiated","Telephone","The cheese was sold/distributed to Laubscher Cheese 1468 Perry Highway Mercer, PA 16137, contact is Kevin at 800-798-4015; the liquid whey was sold/distributed to Miceli's Cheese 2721 E. 90th St Cleveland, Ohio 44104, contact is Cominick at 800-551-7196 Ext. 125.","F-1552-2013","Class II","40 lbs Cheddar Cheese block wrapped in flexible plastic vacuum packaging, one block per box. ","Each 40 pound block of cheese had the date code of 05/20/13 and the vat letter. Each box of cheese had the manufacturing plant code 39-073 printed on the box. ",".","1,540-40 lbs blocks","The raw milk used to manufacture cheese was not tested for the concentration of Beta Lactam antibiotics, which are allergens. ",6/13/2013,"06/13/2013",7/10/2013,"07/10/2013"
"Drugs",65479,"Ongoing","Main Street Family Pharmacy, LLC","Newbern","TN","US","Voluntary: Firm Initiated","Telephone","nationwide, specifically: AK, AL, AZ, CA, CO, CT, DC, FL, GA, HI, IL, IN, KS, KY, LA, MA, MD, MN, MO, MS, NC, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, SC, TN, TX, UT, VA, WA, WI, and WV","D-079-2014","Class II","Dexamethasone sodium phosphate, Main Street Compounding Pharmacy, 126 East Main Street, Newbern, TN 38059, 888-658-6200","all codes distributed prior to and including 05/23/2013",".","1 unit","The firm received seven reports of adverse reactions in the form of skin abscesses potentially linked to compounded preservative-free methylprednisolone 80mg/ml 10 ml vials. ",5/28/2013,"05/28/2013",12/11/2013,"12/11/2013"
"Drugs",65479,"Ongoing","Main Street Family Pharmacy, LLC","Newbern","TN","US","Voluntary: Firm Initiated","Telephone","nationwide, specifically: AK, AL, AZ, CA, CO, CT, DC, FL, GA, HI, IL, IN, KS, KY, LA, MA, MD, MN, MO, MS, NC, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, SC, TN, TX, UT, VA, WA, WI, and WV","D-247-2014","Class II","Mitomycin 2ml (full Strength), Main Street Compounding Pharmacy, 126 East Main Street, Newbern, TN 38059, 888-658-6200","all codes distributed prior to and including 05/23/2013",".","32 units","The firm received seven reports of adverse reactions in the form of skin abscesses potentially linked to compounded preservative-free methylprednisolone 80mg/ml 10 ml vials. ",5/28/2013,"05/28/2013",12/11/2013,"12/11/2013"
"Drugs",65479,"Ongoing","Main Street Family Pharmacy, LLC","Newbern","TN","US","Voluntary: Firm Initiated","Telephone","nationwide, specifically: AK, AL, AZ, CA, CO, CT, DC, FL, GA, HI, IL, IN, KS, KY, LA, MA, MD, MN, MO, MS, NC, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, SC, TN, TX, UT, VA, WA, WI, and WV","D-285-2014","Class II","Testosterone 200mg, 10ml Main Street Compounding Pharmacy, 126 East Main Street, Newbern, TN 38059, 888-658-6200","distributed prior to and including 05/23/2013",".","407 units","The firm received seven reports of adverse reactions in the form of skin abscesses potentially linked to compounded preservative-free methylprednisolone 80mg/ml 10 ml vials. ",5/28/2013,"05/28/2013",12/11/2013,"12/11/2013"
"Drugs",65479,"Ongoing","Main Street Family Pharmacy, LLC","Newbern","TN","US","Voluntary: Firm Initiated","Telephone","nationwide, specifically: AK, AL, AZ, CA, CO, CT, DC, FL, GA, HI, IL, IN, KS, KY, LA, MA, MD, MN, MO, MS, NC, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, SC, TN, TX, UT, VA, WA, WI, and WV","D-162-2014","Class II","Lidocaine 1% 30ml (PF), Main Street Compounding Pharmacy, 126 East Main Street, Newbern, TN 38059, 888-658-6200","all codes distributed prior to and including 05/23/2013",".","56 units","The firm received seven reports of adverse reactions in the form of skin abscesses potentially linked to compounded preservative-free methylprednisolone 80mg/ml 10 ml vials. ",5/28/2013,"05/28/2013",12/11/2013,"12/11/2013"
"Drugs",65479,"Ongoing","Main Street Family Pharmacy, LLC","Newbern","TN","US","Voluntary: Firm Initiated","Telephone","nationwide, specifically: AK, AL, AZ, CA, CO, CT, DC, FL, GA, HI, IL, IN, KS, KY, LA, MA, MD, MN, MO, MS, NC, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, SC, TN, TX, UT, VA, WA, WI, and WV","D-303-2014","Class II","Testosterone Pellets 225mg, Main Street Compounding Pharmacy, 126 East Main Street, Newbern, TN 38059, 888-658-6200","all codes distributed prior to and including 05/23/2013",".","3714 units","The firm received seven reports of adverse reactions in the form of skin abscesses potentially linked to compounded preservative-free methylprednisolone 80mg/ml 10 ml vials. ",5/28/2013,"05/28/2013",12/11/2013,"12/11/2013"
"Drugs",65479,"Ongoing","Main Street Family Pharmacy, LLC","Newbern","TN","US","Voluntary: Firm Initiated","Telephone","nationwide, specifically: AK, AL, AZ, CA, CO, CT, DC, FL, GA, HI, IL, IN, KS, KY, LA, MA, MD, MN, MO, MS, NC, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, SC, TN, TX, UT, VA, WA, WI, and WV","D-211-2014","Class II","Methylprednisolone 100mg w/lidocaine, 10ml Main Street Compounding Pharmacy, 126 East Main Street, Newbern, TN 38059, 888-658-6200","all codes distributed prior to and including 05/23/2013",".","198 units","The firm received seven reports of adverse reactions in the form of skin abscesses potentially linked to compounded preservative-free methylprednisolone 80mg/ml 10 ml vials. ",5/28/2013,"05/28/2013",12/11/2013,"12/11/2013"
"Drugs",65479,"Ongoing","Main Street Family Pharmacy, LLC","Newbern","TN","US","Voluntary: Firm Initiated","Telephone","nationwide, specifically: AK, AL, AZ, CA, CO, CT, DC, FL, GA, HI, IL, IN, KS, KY, LA, MA, MD, MN, MO, MS, NC, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, SC, TN, TX, UT, VA, WA, WI, and WV","D-137-2014","Class II","HCG 350 iu prefilled syringes, Main Street Compounding Pharmacy, 126 East Main Street, Newbern, TN 38059, 888-658-6200","all codes distributed prior to and including 05/23/2013",".","12757 units","The firm received seven reports of adverse reactions in the form of skin abscesses potentially linked to compounded preservative-free methylprednisolone 80mg/ml 10 ml vials. ",5/28/2013,"05/28/2013",12/11/2013,"12/11/2013"
"Drugs",65479,"Ongoing","Main Street Family Pharmacy, LLC","Newbern","TN","US","Voluntary: Firm Initiated","Telephone","nationwide, specifically: AK, AL, AZ, CA, CO, CT, DC, FL, GA, HI, IL, IN, KS, KY, LA, MA, MD, MN, MO, MS, NC, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, SC, TN, TX, UT, VA, WA, WI, and WV","D-217-2014","Class II","Methylprednisolone 40mg PF 2ml, Main Street Compounding Pharmacy, 126 East Main Street, Newbern, TN 38059, 888-658-6200","all codes distributed prior to and including 05/23/2013",".","20 units","The firm received seven reports of adverse reactions in the form of skin abscesses potentially linked to compounded preservative-free methylprednisolone 80mg/ml 10 ml vials. ",5/28/2013,"05/28/2013",12/11/2013,"12/11/2013"
"Drugs",65479,"Ongoing","Main Street Family Pharmacy, LLC","Newbern","TN","US","Voluntary: Firm Initiated","Telephone","nationwide, specifically: AK, AL, AZ, CA, CO, CT, DC, FL, GA, HI, IL, IN, KS, KY, LA, MA, MD, MN, MO, MS, NC, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, SC, TN, TX, UT, VA, WA, WI, and WV","D-034-2014","Class II","AMIC-12 with lido 10ml, Main Street Compounding Pharmacy, 126 East Main Street, Newbern, TN 38059, 888-658-6200","all codes distributed prior to and including 05/23/2013",".","7 units","The firm received seven reports of adverse reactions in the form of skin abscesses potentially linked to compounded preservative-free methylprednisolone 80mg/ml 10 ml vials. ",5/28/2013,"05/28/2013",12/11/2013,"12/11/2013"
"Drugs",65479,"Ongoing","Main Street Family Pharmacy, LLC","Newbern","TN","US","Voluntary: Firm Initiated","Telephone","nationwide, specifically: AK, AL, AZ, CA, CO, CT, DC, FL, GA, HI, IL, IN, KS, KY, LA, MA, MD, MN, MO, MS, NC, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, SC, TN, TX, UT, VA, WA, WI, and WV","D-156-2014","Class II","Let Gel, Main Street Compounding Pharmacy, 126 East Main Street, Newbern, TN 38059, 888-658-6200","all codes distributed prior to and including 05/23/2013",".","255 units","The firm received seven reports of adverse reactions in the form of skin abscesses potentially linked to compounded preservative-free methylprednisolone 80mg/ml 10 ml vials. ",5/28/2013,"05/28/2013",12/11/2013,"12/11/2013"
"Drugs",65479,"Ongoing","Main Street Family Pharmacy, LLC","Newbern","TN","US","Voluntary: Firm Initiated","Telephone","nationwide, specifically: AK, AL, AZ, CA, CO, CT, DC, FL, GA, HI, IL, IN, KS, KY, LA, MA, MD, MN, MO, MS, NC, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, SC, TN, TX, UT, VA, WA, WI, and WV","D-261-2014","Class II","Pre-Menopausal Pack 3rd Month, Main Street Compounding Pharmacy, 126 East Main Street, Newbern, TN 38059, 888-658-6200","all codes distributed prior to and including 05/23/2013",".","12 units","The firm received seven reports of adverse reactions in the form of skin abscesses potentially linked to compounded preservative-free methylprednisolone 80mg/ml 10 ml vials. ",5/28/2013,"05/28/2013",12/11/2013,"12/11/2013"
"Drugs",65479,"Ongoing","Main Street Family Pharmacy, LLC","Newbern","TN","US","Voluntary: Firm Initiated","Telephone","nationwide, specifically: AK, AL, AZ, CA, CO, CT, DC, FL, GA, HI, IL, IN, KS, KY, LA, MA, MD, MN, MO, MS, NC, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, SC, TN, TX, UT, VA, WA, WI, and WV","D-265-2014","Class II","Sermorelin 3mg, Main Street Compounding Pharmacy, 126 East Main Street, Newbern, TN 38059, 888-658-6200","all codes distributed prior to and including 05/23/2013",".","71 units","The firm received seven reports of adverse reactions in the form of skin abscesses potentially linked to compounded preservative-free methylprednisolone 80mg/ml 10 ml vials. ",5/28/2013,"05/28/2013",12/11/2013,"12/11/2013"
"Drugs",65479,"Ongoing","Main Street Family Pharmacy, LLC","Newbern","TN","US","Voluntary: Firm Initiated","Telephone","nationwide, specifically: AK, AL, AZ, CA, CO, CT, DC, FL, GA, HI, IL, IN, KS, KY, LA, MA, MD, MN, MO, MS, NC, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, SC, TN, TX, UT, VA, WA, WI, and WV","D-272-2014","Class II","Sodium Tetradecyl Sulfate 5.0% 30ml, Main Street Compounding Pharmacy, 126 East Main Street, Newbern, TN 38059, 888-658-6200","all codes distributed prior to and including 05/23/2013",".","3 units","The firm received seven reports of adverse reactions in the form of skin abscesses potentially linked to compounded preservative-free methylprednisolone 80mg/ml 10 ml vials. ",5/28/2013,"05/28/2013",12/11/2013,"12/11/2013"
"Drugs",65479,"Ongoing","Main Street Family Pharmacy, LLC","Newbern","TN","US","Voluntary: Firm Initiated","Telephone","nationwide, specifically: AK, AL, AZ, CA, CO, CT, DC, FL, GA, HI, IL, IN, KS, KY, LA, MA, MD, MN, MO, MS, NC, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, SC, TN, TX, UT, VA, WA, WI, and WV","D-245-2014","Class II","Mitomycin 0.02%,2.5ml Main Street Compounding Pharmacy, 126 East Main Street, Newbern, TN 38059, 888-658-6200","all codes distributed prior to and including 05/23/2013",".","4 units","The firm received seven reports of adverse reactions in the form of skin abscesses potentially linked to compounded preservative-free methylprednisolone 80mg/ml 10 ml vials. ",5/28/2013,"05/28/2013",12/11/2013,"12/11/2013"
"Drugs",65479,"Ongoing","Main Street Family Pharmacy, LLC","Newbern","TN","US","Voluntary: Firm Initiated","Telephone","nationwide, specifically: AK, AL, AZ, CA, CO, CT, DC, FL, GA, HI, IL, IN, KS, KY, LA, MA, MD, MN, MO, MS, NC, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, SC, TN, TX, UT, VA, WA, WI, and WV","D-056-2014","Class II","Betamethasone 6mg 10ml PF, Main Street Compounding Pharmacy, 126 East Main Street, Newbern, TN 38059, 888-658-6200","all codes distributed prior to and including 05/23/2013",".","2 units","The firm received seven reports of adverse reactions in the form of skin abscesses potentially linked to compounded preservative-free methylprednisolone 80mg/ml 10 ml vials. ",5/28/2013,"05/28/2013",12/11/2013,"12/11/2013"
"Drugs",65479,"Ongoing","Main Street Family Pharmacy, LLC","Newbern","TN","US","Voluntary: Firm Initiated","Telephone","nationwide, specifically: AK, AL, AZ, CA, CO, CT, DC, FL, GA, HI, IL, IN, KS, KY, LA, MA, MD, MN, MO, MS, NC, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, SC, TN, TX, UT, VA, WA, WI, and WV","D-202-2014","Class II","Medroxyprogesterone (PF) 150mg/10ml, Main Street Compounding Pharmacy, 126 East Main Street, Newbern, TN 38059, 888-658-6200","all codes distributed prior to and including 05/23/2013",".","43 units","The firm received seven reports of adverse reactions in the form of skin abscesses potentially linked to compounded preservative-free methylprednisolone 80mg/ml 10 ml vials. ",5/28/2013,"05/28/2013",12/11/2013,"12/11/2013"
"Drugs",65479,"Ongoing","Main Street Family Pharmacy, LLC","Newbern","TN","US","Voluntary: Firm Initiated","Telephone","nationwide, specifically: AK, AL, AZ, CA, CO, CT, DC, FL, GA, HI, IL, IN, KS, KY, LA, MA, MD, MN, MO, MS, NC, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, SC, TN, TX, UT, VA, WA, WI, and WV","D-151-2014","Class II","HCG Diet Kit, Main Street Compounding Pharmacy, 126 East Main Street, Newbern, TN 38059, 888-658-6200","all codes distributed prior to and including 05/23/2013",".","18 units","The firm received seven reports of adverse reactions in the form of skin abscesses potentially linked to compounded preservative-free methylprednisolone 80mg/ml 10 ml vials. ",5/28/2013,"05/28/2013",12/11/2013,"12/11/2013"
"Drugs",65479,"Ongoing","Main Street Family Pharmacy, LLC","Newbern","TN","US","Voluntary: Firm Initiated","Telephone","nationwide, specifically: AK, AL, AZ, CA, CO, CT, DC, FL, GA, HI, IL, IN, KS, KY, LA, MA, MD, MN, MO, MS, NC, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, SC, TN, TX, UT, VA, WA, WI, and WV","D-069-2014","Class II","Cyclosporine Drops (compounded), Main Street Compounding Pharmacy, 126 East Main Street, Newbern, TN 38059, 888-658-6200","all codes distributed prior to and including 05/23/2013",".","15 units","The firm received seven reports of adverse reactions in the form of skin abscesses potentially linked to compounded preservative-free methylprednisolone 80mg/ml 10 ml vials. ",5/28/2013,"05/28/2013",12/11/2013,"12/11/2013"
"Drugs",65479,"Ongoing","Main Street Family Pharmacy, LLC","Newbern","TN","US","Voluntary: Firm Initiated","Telephone","nationwide, specifically: AK, AL, AZ, CA, CO, CT, DC, FL, GA, HI, IL, IN, KS, KY, LA, MA, MD, MN, MO, MS, NC, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, SC, TN, TX, UT, VA, WA, WI, and WV","D-093-2014","Class II","Estradiol Pellets 25mg, Main Street Compounding Pharmacy, 126 East Main Street, Newbern, TN 38059, 888-658-6200","all codes distributed prior to and including 05/23/2013",".","234 units","The firm received seven reports of adverse reactions in the form of skin abscesses potentially linked to compounded preservative-free methylprednisolone 80mg/ml 10 ml vials. ",5/28/2013,"05/28/2013",12/11/2013,"12/11/2013"
"Drugs",65479,"Ongoing","Main Street Family Pharmacy, LLC","Newbern","TN","US","Voluntary: Firm Initiated","Telephone","nationwide, specifically: AK, AL, AZ, CA, CO, CT, DC, FL, GA, HI, IL, IN, KS, KY, LA, MA, MD, MN, MO, MS, NC, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, SC, TN, TX, UT, VA, WA, WI, and WV","D-317-2014","Class II","Triamcinolone Acetonide 40mg/ml, Main Street Compounding Pharmacy, 126 East Main Street, Newbern, TN 38059, 888-658-6200","all codes distributed prior to and including 05/23/2013",".","66 units","The firm received seven reports of adverse reactions in the form of skin abscesses potentially linked to compounded preservative-free methylprednisolone 80mg/ml 10 ml vials. ",5/28/2013,"05/28/2013",12/11/2013,"12/11/2013"
"Drugs",65479,"Ongoing","Main Street Family Pharmacy, LLC","Newbern","TN","US","Voluntary: Firm Initiated","Telephone","nationwide, specifically: AK, AL, AZ, CA, CO, CT, DC, FL, GA, HI, IL, IN, KS, KY, LA, MA, MD, MN, MO, MS, NC, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, SC, TN, TX, UT, VA, WA, WI, and WV","D-027-2014","Class II","Acetylcystein 20% 90ml, Main Street Compounding Pharmacy, 126 East Main Street, Newbern, TN 38059, 888-658-6200","all codes distributed prior to and including 05/23/2013",".","1 unit","The firm received seven reports of adverse reactions in the form of skin abscesses potentially linked to compounded preservative-free methylprednisolone 80mg/ml 10 ml vials. ",5/28/2013,"05/28/2013",12/11/2013,"12/11/2013"
"Drugs",65479,"Ongoing","Main Street Family Pharmacy, LLC","Newbern","TN","US","Voluntary: Firm Initiated","Telephone","nationwide, specifically: AK, AL, AZ, CA, CO, CT, DC, FL, GA, HI, IL, IN, KS, KY, LA, MA, MD, MN, MO, MS, NC, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, SC, TN, TX, UT, VA, WA, WI, and WV","D-052-2014","Class II","Betamethasone Na phosphate 4mg/ml 10ml, Main Street Compounding Pharmacy, 126 East Main Street, Newbern, TN 38059, 888-658-6200","all codes distributed prior to and including 05/23/2013",".","20 units","The firm received seven reports of adverse reactions in the form of skin abscesses potentially linked to compounded preservative-free methylprednisolone 80mg/ml 10 ml vials. ",5/28/2013,"05/28/2013",12/11/2013,"12/11/2013"
"Drugs",65479,"Ongoing","Main Street Family Pharmacy, LLC","Newbern","TN","US","Voluntary: Firm Initiated","Telephone","nationwide, specifically: AK, AL, AZ, CA, CO, CT, DC, FL, GA, HI, IL, IN, KS, KY, LA, MA, MD, MN, MO, MS, NC, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, SC, TN, TX, UT, VA, WA, WI, and WV","D-243-2014","Class II","Minoxidil 10% 60ml, Main Street Compounding Pharmacy, 126 East Main Street, Newbern, TN 38059, 888-658-6200","all codes distributed prior to and including 05/23/2013",".","11 units","The firm received seven reports of adverse reactions in the form of skin abscesses potentially linked to compounded preservative-free methylprednisolone 80mg/ml 10 ml vials. ",5/28/2013,"05/28/2013",12/11/2013,"12/11/2013"
"Drugs",65479,"Ongoing","Main Street Family Pharmacy, LLC","Newbern","TN","US","Voluntary: Firm Initiated","Telephone","nationwide, specifically: AK, AL, AZ, CA, CO, CT, DC, FL, GA, HI, IL, IN, KS, KY, LA, MA, MD, MN, MO, MS, NC, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, SC, TN, TX, UT, VA, WA, WI, and WV","D-105-2014","Class II","HCG 1000iu PFS, Main Street Compounding Pharmacy, 126 East Main Street, Newbern, TN 38059, 888-658-6200","all codes distributed prior to and including 05/23/2013",".","115 units","The firm received seven reports of adverse reactions in the form of skin abscesses potentially linked to compounded preservative-free methylprednisolone 80mg/ml 10 ml vials. ",5/28/2013,"05/28/2013",12/11/2013,"12/11/2013"
"Drugs",65479,"Ongoing","Main Street Family Pharmacy, LLC","Newbern","TN","US","Voluntary: Firm Initiated","Telephone","nationwide, specifically: AK, AL, AZ, CA, CO, CT, DC, FL, GA, HI, IL, IN, KS, KY, LA, MA, MD, MN, MO, MS, NC, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, SC, TN, TX, UT, VA, WA, WI, and WV","D-167-2014","Class II","Lincomycin 300mg, Main Street Compounding Pharmacy, 126 East Main Street, Newbern, TN 38059, 888-658-6200","all codes distributed prior to and including 05/23/2013",".","33 units","The firm received seven reports of adverse reactions in the form of skin abscesses potentially linked to compounded preservative-free methylprednisolone 80mg/ml 10 ml vials. ",5/28/2013,"05/28/2013",12/11/2013,"12/11/2013"
"Drugs",65479,"Ongoing","Main Street Family Pharmacy, LLC","Newbern","TN","US","Voluntary: Firm Initiated","Telephone","nationwide, specifically: AK, AL, AZ, CA, CO, CT, DC, FL, GA, HI, IL, IN, KS, KY, LA, MA, MD, MN, MO, MS, NC, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, SC, TN, TX, UT, VA, WA, WI, and WV","D-143-2014","Class II","HCG 400 iu prefilled syringes, Main Street Compounding Pharmacy, 126 East Main Street, Newbern, TN 38059, 888-658-6200","all codes distributed prior to and including 05/23/2013",".","918 units","The firm received seven reports of adverse reactions in the form of skin abscesses potentially linked to compounded preservative-free methylprednisolone 80mg/ml 10 ml vials. ",5/28/2013,"05/28/2013",12/11/2013,"12/11/2013"
"Drugs",65479,"Ongoing","Main Street Family Pharmacy, LLC","Newbern","TN","US","Voluntary: Firm Initiated","Telephone","nationwide, specifically: AK, AL, AZ, CA, CO, CT, DC, FL, GA, HI, IL, IN, KS, KY, LA, MA, MD, MN, MO, MS, NC, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, SC, TN, TX, UT, VA, WA, WI, and WV","D-177-2014","Class II","Lipotonix Plus 30ml w/o methion, Main Street Compounding Pharmacy, 126 East Main Street, Newbern, TN 38059, 888-658-6200","all codes distributed prior to and including 05/23/2013",".","5 units","The firm received seven reports of adverse reactions in the form of skin abscesses potentially linked to compounded preservative-free methylprednisolone 80mg/ml 10 ml vials. ",5/28/2013,"05/28/2013",12/11/2013,"12/11/2013"
"Drugs",65479,"Ongoing","Main Street Family Pharmacy, LLC","Newbern","TN","US","Voluntary: Firm Initiated","Telephone","nationwide, specifically: AK, AL, AZ, CA, CO, CT, DC, FL, GA, HI, IL, IN, KS, KY, LA, MA, MD, MN, MO, MS, NC, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, SC, TN, TX, UT, VA, WA, WI, and WV","D-122-2014","Class II","HCG 230 iu prefilled syringes, Main Street Compounding Pharmacy, 126 East Main Street, Newbern, TN 38059, 888-658-6200","all codes distributed prior to and including 05/23/2013",".","231 units","The firm received seven reports of adverse reactions in the form of skin abscesses potentially linked to compounded preservative-free methylprednisolone 80mg/ml 10 ml vials. ",5/28/2013,"05/28/2013",12/11/2013,"12/11/2013"
"Drugs",65479,"Ongoing","Main Street Family Pharmacy, LLC","Newbern","TN","US","Voluntary: Firm Initiated","Telephone","nationwide, specifically: AK, AL, AZ, CA, CO, CT, DC, FL, GA, HI, IL, IN, KS, KY, LA, MA, MD, MN, MO, MS, NC, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, SC, TN, TX, UT, VA, WA, WI, and WV","D-251-2014","Class II","Mitomycin/Mannitol, Main Street Compounding Pharmacy, 126 East Main Street, Newbern, TN 38059, 888-658-6200","all codes distributed prior to and including 05/23/2013",".","26 units","The firm received seven reports of adverse reactions in the form of skin abscesses potentially linked to compounded preservative-free methylprednisolone 80mg/ml 10 ml vials. ",5/28/2013,"05/28/2013",12/11/2013,"12/11/2013"
"Drugs",65479,"Ongoing","Main Street Family Pharmacy, LLC","Newbern","TN","US","Voluntary: Firm Initiated","Telephone","nationwide, specifically: AK, AL, AZ, CA, CO, CT, DC, FL, GA, HI, IL, IN, KS, KY, LA, MA, MD, MN, MO, MS, NC, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, SC, TN, TX, UT, VA, WA, WI, and WV","D-172-2014","Class II","Lipo C 30ml, Methionine 12.5mg, Inositol 50mg, Choline 100mg, Methylcobalamin 1mg, L-Carnitine 200mg, Main Street Compounding Pharmacy, 126 East Main Street, Newbern, TN 38059, 888-658-6200","all codes distributed prior to and including 05/23/2013",".","23 units","The firm received seven reports of adverse reactions in the form of skin abscesses potentially linked to compounded preservative-free methylprednisolone 80mg/ml 10 ml vials. ",5/28/2013,"05/28/2013",12/11/2013,"12/11/2013"
"Drugs",65479,"Ongoing","Main Street Family Pharmacy, LLC","Newbern","TN","US","Voluntary: Firm Initiated","Telephone","nationwide, specifically: AK, AL, AZ, CA, CO, CT, DC, FL, GA, HI, IL, IN, KS, KY, LA, MA, MD, MN, MO, MS, NC, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, SC, TN, TX, UT, VA, WA, WI, and WV","D-144-2014","Class II","HCG 450 iu prefilled syringes, Main Street Compounding Pharmacy, 126 East Main Street, Newbern, TN 38059, 888-658-6200","all codes distributed prior to and including 05/23/2013",".","22 units","The firm received seven reports of adverse reactions in the form of skin abscesses potentially linked to compounded preservative-free methylprednisolone 80mg/ml 10 ml vials. ",5/28/2013,"05/28/2013",12/11/2013,"12/11/2013"
"Drugs",65479,"Ongoing","Main Street Family Pharmacy, LLC","Newbern","TN","US","Voluntary: Firm Initiated","Telephone","nationwide, specifically: AK, AL, AZ, CA, CO, CT, DC, FL, GA, HI, IL, IN, KS, KY, LA, MA, MD, MN, MO, MS, NC, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, SC, TN, TX, UT, VA, WA, WI, and WV","D-306-2014","Class II","Testosterone Pellets 50mg, Main Street Compounding Pharmacy, 126 East Main Street, Newbern, TN 38059, 888-658-6200","all codes distributed prior to and including 05/23/2013",".","701 units","The firm received seven reports of adverse reactions in the form of skin abscesses potentially linked to compounded preservative-free methylprednisolone 80mg/ml 10 ml vials. ",5/28/2013,"05/28/2013",12/11/2013,"12/11/2013"
"Drugs",65479,"Ongoing","Main Street Family Pharmacy, LLC","Newbern","TN","US","Voluntary: Firm Initiated","Telephone","nationwide, specifically: AK, AL, AZ, CA, CO, CT, DC, FL, GA, HI, IL, IN, KS, KY, LA, MA, MD, MN, MO, MS, NC, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, SC, TN, TX, UT, VA, WA, WI, and WV","D-236-2014","Class II","Mic Ultra 30ml, Main Street Compounding Pharmacy, 126 East Main Street, Newbern, TN 38059, 888-658-6200","all codes distributed prior to and including 05/23/2013",".","680 units","The firm received seven reports of adverse reactions in the form of skin abscesses potentially linked to compounded preservative-free methylprednisolone 80mg/ml 10 ml vials. ",5/28/2013,"05/28/2013",12/11/2013,"12/11/2013"
"Drugs",65479,"Ongoing","Main Street Family Pharmacy, LLC","Newbern","TN","US","Voluntary: Firm Initiated","Telephone","nationwide, specifically: AK, AL, AZ, CA, CO, CT, DC, FL, GA, HI, IL, IN, KS, KY, LA, MA, MD, MN, MO, MS, NC, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, SC, TN, TX, UT, VA, WA, WI, and WV","D-053-2014","Class II","Betamethasone 6.5mg 10ml, Main Street Compounding Pharmacy, 126 East Main Street, Newbern, TN 38059, 888-658-6200","all codes distributed prior to and including 05/23/2013",".","9 units","The firm received seven reports of adverse reactions in the form of skin abscesses potentially linked to compounded preservative-free methylprednisolone 80mg/ml 10 ml vials. ",5/28/2013,"05/28/2013",12/11/2013,"12/11/2013"
"Drugs",65479,"Ongoing","Main Street Family Pharmacy, LLC","Newbern","TN","US","Voluntary: Firm Initiated","Telephone","nationwide, specifically: AK, AL, AZ, CA, CO, CT, DC, FL, GA, HI, IL, IN, KS, KY, LA, MA, MD, MN, MO, MS, NC, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, SC, TN, TX, UT, VA, WA, WI, and WV","D-185-2014","Class II","Lipotropic 2ml PFS, Main Street Compounding Pharmacy, 126 East Main Street, Newbern, TN 38059, 888-658-6200","all codes distributed prior to and including 05/23/2013",".","6 units","The firm received seven reports of adverse reactions in the form of skin abscesses potentially linked to compounded preservative-free methylprednisolone 80mg/ml 10 ml vials. ",5/28/2013,"05/28/2013",12/11/2013,"12/11/2013"
"Drugs",65479,"Ongoing","Main Street Family Pharmacy, LLC","Newbern","TN","US","Voluntary: Firm Initiated","Telephone","nationwide, specifically: AK, AL, AZ, CA, CO, CT, DC, FL, GA, HI, IL, IN, KS, KY, LA, MA, MD, MN, MO, MS, NC, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, SC, TN, TX, UT, VA, WA, WI, and WV","D-161-2014","Class II","Lidocaine 1% 30ml, Main Street Compounding Pharmacy, 126 East Main Street, Newbern, TN 38059, 888-658-6200","all codes distributed prior to and including 05/23/2013",".","242 units","The firm received seven reports of adverse reactions in the form of skin abscesses potentially linked to compounded preservative-free methylprednisolone 80mg/ml 10 ml vials. ",5/28/2013,"05/28/2013",12/11/2013,"12/11/2013"
"Drugs",65479,"Ongoing","Main Street Family Pharmacy, LLC","Newbern","TN","US","Voluntary: Firm Initiated","Telephone","nationwide, specifically: AK, AL, AZ, CA, CO, CT, DC, FL, GA, HI, IL, IN, KS, KY, LA, MA, MD, MN, MO, MS, NC, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, SC, TN, TX, UT, VA, WA, WI, and WV","D-075-2014","Class II","Dexamethasone 8mg 10ml, Main Street Compounding Pharmacy, 126 East Main Street, Newbern, TN 38059, 888-658-6200","all codes distributed prior to and including 05/23/2013",".","17 units","The firm received seven reports of adverse reactions in the form of skin abscesses potentially linked to compounded preservative-free methylprednisolone 80mg/ml 10 ml vials. ",5/28/2013,"05/28/2013",12/11/2013,"12/11/2013"
"Drugs",65479,"Ongoing","Main Street Family Pharmacy, LLC","Newbern","TN","US","Voluntary: Firm Initiated","Telephone","nationwide, specifically: AK, AL, AZ, CA, CO, CT, DC, FL, GA, HI, IL, IN, KS, KY, LA, MA, MD, MN, MO, MS, NC, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, SC, TN, TX, UT, VA, WA, WI, and WV","D-061-2014","Class II","Betamethasone 9mg/ml PF, Main Street Compounding Pharmacy, 126 East Main Street, Newbern, TN 38059, 888-658-6200","all codes distributed prior to and including 05/23/2013",".","43 units","The firm received seven reports of adverse reactions in the form of skin abscesses potentially linked to compounded preservative-free methylprednisolone 80mg/ml 10 ml vials. ",5/28/2013,"05/28/2013",12/11/2013,"12/11/2013"
"Drugs",65479,"Ongoing","Main Street Family Pharmacy, LLC","Newbern","TN","US","Voluntary: Firm Initiated","Telephone","nationwide, specifically: AK, AL, AZ, CA, CO, CT, DC, FL, GA, HI, IL, IN, KS, KY, LA, MA, MD, MN, MO, MS, NC, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, SC, TN, TX, UT, VA, WA, WI, and WV","D-229-2014","Class II","MIC 25/50/50 w/333mg B-12, 10ml Main Street Compounding Pharmacy, 126 East Main Street, Newbern, TN 38059, 888-658-6200","all codes distributed prior to and including 05/23/2013",".","10 units","The firm received seven reports of adverse reactions in the form of skin abscesses potentially linked to compounded preservative-free methylprednisolone 80mg/ml 10 ml vials. ",5/28/2013,"05/28/2013",12/11/2013,"12/11/2013"
"Drugs",65479,"Ongoing","Main Street Family Pharmacy, LLC","Newbern","TN","US","Voluntary: Firm Initiated","Telephone","nationwide, specifically: AK, AL, AZ, CA, CO, CT, DC, FL, GA, HI, IL, IN, KS, KY, LA, MA, MD, MN, MO, MS, NC, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, SC, TN, TX, UT, VA, WA, WI, and WV","D-207-2014","Class II","Methylcobalamin 1mg/ml 50ml, Main Street Compounding Pharmacy, 126 East Main Street, Newbern, TN 38059, 888-658-6200","all codes distributed prior to and including 05/23/2013",".","265 units","The firm received seven reports of adverse reactions in the form of skin abscesses potentially linked to compounded preservative-free methylprednisolone 80mg/ml 10 ml vials. ",5/28/2013,"05/28/2013",12/11/2013,"12/11/2013"
"Drugs",65479,"Ongoing","Main Street Family Pharmacy, LLC","Newbern","TN","US","Voluntary: Firm Initiated","Telephone","nationwide, specifically: AK, AL, AZ, CA, CO, CT, DC, FL, GA, HI, IL, IN, KS, KY, LA, MA, MD, MN, MO, MS, NC, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, SC, TN, TX, UT, VA, WA, WI, and WV","D-237-2014","Class II","Mic Ultra 50ml, Main Street Compounding Pharmacy, 126 East Main Street, Newbern, TN 38059, 888-658-6200","all codes distributed prior to and including 05/23/2013",".","208 units","The firm received seven reports of adverse reactions in the form of skin abscesses potentially linked to compounded preservative-free methylprednisolone 80mg/ml 10 ml vials. ",5/28/2013,"05/28/2013",12/11/2013,"12/11/2013"
"Drugs",65479,"Ongoing","Main Street Family Pharmacy, LLC","Newbern","TN","US","Voluntary: Firm Initiated","Telephone","nationwide, specifically: AK, AL, AZ, CA, CO, CT, DC, FL, GA, HI, IL, IN, KS, KY, LA, MA, MD, MN, MO, MS, NC, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, SC, TN, TX, UT, VA, WA, WI, and WV","D-102-2014","Class II","Gomenol 10ml, Main Street Compounding Pharmacy, 126 East Main Street, Newbern, TN 38059, 888-658-6200","all codes distributed prior to and including 05/23/2013",".","15 units","The firm received seven reports of adverse reactions in the form of skin abscesses potentially linked to compounded preservative-free methylprednisolone 80mg/ml 10 ml vials. ",5/28/2013,"05/28/2013",12/11/2013,"12/11/2013"
"Drugs",65479,"Ongoing","Main Street Family Pharmacy, LLC","Newbern","TN","US","Voluntary: Firm Initiated","Telephone","nationwide, specifically: AK, AL, AZ, CA, CO, CT, DC, FL, GA, HI, IL, IN, KS, KY, LA, MA, MD, MN, MO, MS, NC, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, SC, TN, TX, UT, VA, WA, WI, and WV","D-071-2014","Class II","Dexamethasone LA 16mg/ml 10ml, Main Street Compounding Pharmacy, 126 East Main Street, Newbern, TN 38059, 888-658-6200","all codes distributed prior to and including 05/23/2013",".","14 units","The firm received seven reports of adverse reactions in the form of skin abscesses potentially linked to compounded preservative-free methylprednisolone 80mg/ml 10 ml vials. ",5/28/2013,"05/28/2013",12/11/2013,"12/11/2013"
"Drugs",65479,"Ongoing","Main Street Family Pharmacy, LLC","Newbern","TN","US","Voluntary: Firm Initiated","Telephone","nationwide, specifically: AK, AL, AZ, CA, CO, CT, DC, FL, GA, HI, IL, IN, KS, KY, LA, MA, MD, MN, MO, MS, NC, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, SC, TN, TX, UT, VA, WA, WI, and WV","D-276-2014","Class II","Taper Pack B, Main Street Compounding Pharmacy, 126 East Main Street, Newbern, TN 38059, 888-658-6200","all codes distributed prior to and including 05/23/2013",".","335 units","The firm received seven reports of adverse reactions in the form of skin abscesses potentially linked to compounded preservative-free methylprednisolone 80mg/ml 10 ml vials. ",5/28/2013,"05/28/2013",12/11/2013,"12/11/2013"
"Drugs",65479,"Ongoing","Main Street Family Pharmacy, LLC","Newbern","TN","US","Voluntary: Firm Initiated","Telephone","nationwide, specifically: AK, AL, AZ, CA, CO, CT, DC, FL, GA, HI, IL, IN, KS, KY, LA, MA, MD, MN, MO, MS, NC, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, SC, TN, TX, UT, VA, WA, WI, and WV","D-305-2014","Class II","Testosterone Pellets 37.5mg, Main Street Compounding Pharmacy, 126 East Main Street, Newbern, TN 38059, 888-658-6200","all codes distributed prior to and including 05/23/2013",".","18 units","The firm received seven reports of adverse reactions in the form of skin abscesses potentially linked to compounded preservative-free methylprednisolone 80mg/ml 10 ml vials. ",5/28/2013,"05/28/2013",12/11/2013,"12/11/2013"
"Drugs",65479,"Ongoing","Main Street Family Pharmacy, LLC","Newbern","TN","US","Voluntary: Firm Initiated","Telephone","nationwide, specifically: AK, AL, AZ, CA, CO, CT, DC, FL, GA, HI, IL, IN, KS, KY, LA, MA, MD, MN, MO, MS, NC, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, SC, TN, TX, UT, VA, WA, WI, and WV","D-263-2014","Class II","Sermorelin 6mg, Main Street Compounding Pharmacy, 126 East Main Street, Newbern, TN 38059, 888-658-6200","all codes distributed prior to and including 05/23/2013",".","706 units","The firm received seven reports of adverse reactions in the form of skin abscesses potentially linked to compounded preservative-free methylprednisolone 80mg/ml 10 ml vials. ",5/28/2013,"05/28/2013",12/11/2013,"12/11/2013"
"Drugs",65479,"Ongoing","Main Street Family Pharmacy, LLC","Newbern","TN","US","Voluntary: Firm Initiated","Telephone","nationwide, specifically: AK, AL, AZ, CA, CO, CT, DC, FL, GA, HI, IL, IN, KS, KY, LA, MA, MD, MN, MO, MS, NC, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, SC, TN, TX, UT, VA, WA, WI, and WV","D-205-2014","Class II","Methylcob 100mcg/ml 30ml, Main Street Compounding Pharmacy, 126 East Main Street, Newbern, TN 38059, 888-658-6200","all codes distributed prior to and including 05/23/2013",".","5 units","The firm received seven reports of adverse reactions in the form of skin abscesses potentially linked to compounded preservative-free methylprednisolone 80mg/ml 10 ml vials. ",5/28/2013,"05/28/2013",12/11/2013,"12/11/2013"
"Drugs",65479,"Ongoing","Main Street Family Pharmacy, LLC","Newbern","TN","US","Voluntary: Firm Initiated","Telephone","nationwide, specifically: AK, AL, AZ, CA, CO, CT, DC, FL, GA, HI, IL, IN, KS, KY, LA, MA, MD, MN, MO, MS, NC, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, SC, TN, TX, UT, VA, WA, WI, and WV","D-107-2014","Class II","HCG 11000u w/B-12, Main Street Compounding Pharmacy, 126 East Main Street, Newbern, TN 38059, 888-658-6200","all codes distributed prior to and including 05/23/2013",".","36 units","The firm received seven reports of adverse reactions in the form of skin abscesses potentially linked to compounded preservative-free methylprednisolone 80mg/ml 10 ml vials. ",5/28/2013,"05/28/2013",12/11/2013,"12/11/2013"
"Drugs",65479,"Ongoing","Main Street Family Pharmacy, LLC","Newbern","TN","US","Voluntary: Firm Initiated","Telephone","nationwide, specifically: AK, AL, AZ, CA, CO, CT, DC, FL, GA, HI, IL, IN, KS, KY, LA, MA, MD, MN, MO, MS, NC, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, SC, TN, TX, UT, VA, WA, WI, and WV","D-219-2014","Class II","Methylprednisolone 40mg, 10ml, Main Street Compounding Pharmacy, 126 East Main Street, Newbern, TN 38059, 888-658-6200","all codes distributed prior to and including 05/23/2013",".","5 units","The firm received seven reports of adverse reactions in the form of skin abscesses potentially linked to compounded preservative-free methylprednisolone 80mg/ml 10 ml vials. ",5/28/2013,"05/28/2013",12/11/2013,"12/11/2013"
"Drugs",65479,"Ongoing","Main Street Family Pharmacy, LLC","Newbern","TN","US","Voluntary: Firm Initiated","Telephone","nationwide, specifically: AK, AL, AZ, CA, CO, CT, DC, FL, GA, HI, IL, IN, KS, KY, LA, MA, MD, MN, MO, MS, NC, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, SC, TN, TX, UT, VA, WA, WI, and WV","D-309-2014","Class II","Tetracaine 2%, Main Street Compounding Pharmacy, 126 East Main Street, Newbern, TN 38059, 888-658-6200","all codes distributed prior to and including 05/23/2013",".","3 units","The firm received seven reports of adverse reactions in the form of skin abscesses potentially linked to compounded preservative-free methylprednisolone 80mg/ml 10 ml vials. ",5/28/2013,"05/28/2013",12/11/2013,"12/11/2013"
"Drugs",65479,"Ongoing","Main Street Family Pharmacy, LLC","Newbern","TN","US","Voluntary: Firm Initiated","Telephone","nationwide, specifically: AK, AL, AZ, CA, CO, CT, DC, FL, GA, HI, IL, IN, KS, KY, LA, MA, MD, MN, MO, MS, NC, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, SC, TN, TX, UT, VA, WA, WI, and WV","D-158-2014","Class II","L-glutathione 200mg/ml 30ml, Main Street Compounding Pharmacy, 126 East Main Street, Newbern, TN 38059, 888-658-6200","all codes distributed prior to and including 05/23/2013",".","3 units","The firm received seven reports of adverse reactions in the form of skin abscesses potentially linked to compounded preservative-free methylprednisolone 80mg/ml 10 ml vials. ",5/28/2013,"05/28/2013",12/11/2013,"12/11/2013"
"Drugs",65479,"Ongoing","Main Street Family Pharmacy, LLC","Newbern","TN","US","Voluntary: Firm Initiated","Telephone","nationwide, specifically: AK, AL, AZ, CA, CO, CT, DC, FL, GA, HI, IL, IN, KS, KY, LA, MA, MD, MN, MO, MS, NC, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, SC, TN, TX, UT, VA, WA, WI, and WV","D-192-2014","Class II","MALE HCG PK 3rd month (320, 330,340, 350iu) Main Street Compounding Pharmacy, 126 East Main Street, Newbern, TN 38059, 888-658-6200","all codes distributed prior to and including 05/23/2013",".","7 units","The firm received seven reports of adverse reactions in the form of skin abscesses potentially linked to compounded preservative-free methylprednisolone 80mg/ml 10 ml vials. ",5/28/2013,"05/28/2013",12/11/2013,"12/11/2013"
"Drugs",65479,"Ongoing","Main Street Family Pharmacy, LLC","Newbern","TN","US","Voluntary: Firm Initiated","Telephone","nationwide, specifically: AK, AL, AZ, CA, CO, CT, DC, FL, GA, HI, IL, IN, KS, KY, LA, MA, MD, MN, MO, MS, NC, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, SC, TN, TX, UT, VA, WA, WI, and WV","D-181-2014","Class II","Lipotropic 1.5ml PFS, Main Street Compounding Pharmacy, 126 East Main Street, Newbern, TN 38059, 888-658-6200","all codes distributed prior to and including 05/23/2013",".","10 units","The firm received seven reports of adverse reactions in the form of skin abscesses potentially linked to compounded preservative-free methylprednisolone 80mg/ml 10 ml vials. ",5/28/2013,"05/28/2013",12/11/2013,"12/11/2013"
"Drugs",65479,"Ongoing","Main Street Family Pharmacy, LLC","Newbern","TN","US","Voluntary: Firm Initiated","Telephone","nationwide, specifically: AK, AL, AZ, CA, CO, CT, DC, FL, GA, HI, IL, IN, KS, KY, LA, MA, MD, MN, MO, MS, NC, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, SC, TN, TX, UT, VA, WA, WI, and WV","D-266-2014","Class II","Single Strength PGE1 20mcg 2ml, Main Street Compounding Pharmacy, 126 East Main Street, Newbern, TN 38059, 888-658-6200","all codes distributed prior to and including 05/23/2013",".","1 unit","The firm received seven reports of adverse reactions in the form of skin abscesses potentially linked to compounded preservative-free methylprednisolone 80mg/ml 10 ml vials. ",5/28/2013,"05/28/2013",12/11/2013,"12/11/2013"
"Drugs",65479,"Ongoing","Main Street Family Pharmacy, LLC","Newbern","TN","US","Voluntary: Firm Initiated","Telephone","nationwide, specifically: AK, AL, AZ, CA, CO, CT, DC, FL, GA, HI, IL, IN, KS, KY, LA, MA, MD, MN, MO, MS, NC, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, SC, TN, TX, UT, VA, WA, WI, and WV","D-155-2014","Class II","L-Carnitine 30ml, Main Street Compounding Pharmacy, 126 East Main Street, Newbern, TN 38059, 888-658-6200","all codes distributed prior to and including 05/23/2013",".","19 units","The firm received seven reports of adverse reactions in the form of skin abscesses potentially linked to compounded preservative-free methylprednisolone 80mg/ml 10 ml vials. ",5/28/2013,"05/28/2013",12/11/2013,"12/11/2013"
"Drugs",65479,"Ongoing","Main Street Family Pharmacy, LLC","Newbern","TN","US","Voluntary: Firm Initiated","Telephone","nationwide, specifically: AK, AL, AZ, CA, CO, CT, DC, FL, GA, HI, IL, IN, KS, KY, LA, MA, MD, MN, MO, MS, NC, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, SC, TN, TX, UT, VA, WA, WI, and WV","D-074-2014","Class II","Dexamethasone 8/4 10ml and 30 ml, Main Street Compounding Pharmacy, 126 East Main Street, Newbern, TN 38059, 888-658-6200","all codes distributed prior to and including 05/23/2013",".","115 units","The firm received seven reports of adverse reactions in the form of skin abscesses potentially linked to compounded preservative-free methylprednisolone 80mg/ml 10 ml vials. ",5/28/2013,"05/28/2013",12/11/2013,"12/11/2013"
"Drugs",65479,"Ongoing","Main Street Family Pharmacy, LLC","Newbern","TN","US","Voluntary: Firm Initiated","Telephone","nationwide, specifically: AK, AL, AZ, CA, CO, CT, DC, FL, GA, HI, IL, IN, KS, KY, LA, MA, MD, MN, MO, MS, NC, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, SC, TN, TX, UT, VA, WA, WI, and WV","D-252-2014","Class II","Oral B-12 30ml--cotton candy, Main Street Compounding Pharmacy, 126 East Main Street, Newbern, TN 38059, 888-658-6200","all codes distributed prior to and including 05/23/2013",".","82 units","The firm received seven reports of adverse reactions in the form of skin abscesses potentially linked to compounded preservative-free methylprednisolone 80mg/ml 10 ml vials. ",5/28/2013,"05/28/2013",12/11/2013,"12/11/2013"
"Drugs",65479,"Ongoing","Main Street Family Pharmacy, LLC","Newbern","TN","US","Voluntary: Firm Initiated","Telephone","nationwide, specifically: AK, AL, AZ, CA, CO, CT, DC, FL, GA, HI, IL, IN, KS, KY, LA, MA, MD, MN, MO, MS, NC, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, SC, TN, TX, UT, VA, WA, WI, and WV","D-076-2014","Class II","Dexamethasone LA 16mg, Main Street Compounding Pharmacy, 126 East Main Street, Newbern, TN 38059, 888-658-6200","all codes distributed prior to and including 05/23/2013",".","151 units","The firm received seven reports of adverse reactions in the form of skin abscesses potentially linked to compounded preservative-free methylprednisolone 80mg/ml 10 ml vials. ",5/28/2013,"05/28/2013",12/11/2013,"12/11/2013"
"Drugs",65479,"Ongoing","Main Street Family Pharmacy, LLC","Newbern","TN","US","Voluntary: Firm Initiated","Telephone","nationwide, specifically: AK, AL, AZ, CA, CO, CT, DC, FL, GA, HI, IL, IN, KS, KY, LA, MA, MD, MN, MO, MS, NC, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, SC, TN, TX, UT, VA, WA, WI, and WV","D-025-2014","Class II","Acetylcystein 10% 120ml, Main Street Compounding Pharmacy, 126 East Main Street, Newbern, TN 38059, 888-658-6200","all codes distributed prior to and including 05/23/2013",".","1 unit","The firm received seven reports of adverse reactions in the form of skin abscesses potentially linked to compounded preservative-free methylprednisolone 80mg/ml 10 ml vials. ",5/28/2013,"05/28/2013",12/11/2013,"12/11/2013"
"Drugs",65479,"Ongoing","Main Street Family Pharmacy, LLC","Newbern","TN","US","Voluntary: Firm Initiated","Telephone","nationwide, specifically: AK, AL, AZ, CA, CO, CT, DC, FL, GA, HI, IL, IN, KS, KY, LA, MA, MD, MN, MO, MS, NC, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, SC, TN, TX, UT, VA, WA, WI, and WV","D-199-2014","Class II","Medroxyprogesterone 150mg w/lido 10ml, Main Street Compounding Pharmacy, 126 East Main Street, Newbern, TN 38059, 888-658-6200","all codes distributed prior to and including 05/23/2013",".","313 units","The firm received seven reports of adverse reactions in the form of skin abscesses potentially linked to compounded preservative-free methylprednisolone 80mg/ml 10 ml vials. ",5/28/2013,"05/28/2013",12/11/2013,"12/11/2013"
"Drugs",65479,"Ongoing","Main Street Family Pharmacy, LLC","Newbern","TN","US","Voluntary: Firm Initiated","Telephone","nationwide, specifically: AK, AL, AZ, CA, CO, CT, DC, FL, GA, HI, IL, IN, KS, KY, LA, MA, MD, MN, MO, MS, NC, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, SC, TN, TX, UT, VA, WA, WI, and WV","D-117-2014","Class II","HCG 2000IU, Main Street Compounding Pharmacy, 126 East Main Street, Newbern, TN 38059, 888-658-6200","all codes distributed prior to and including 05/23/2013",".","11 units","The firm received seven reports of adverse reactions in the form of skin abscesses potentially linked to compounded preservative-free methylprednisolone 80mg/ml 10 ml vials. ",5/28/2013,"05/28/2013",12/11/2013,"12/11/2013"
"Drugs",65479,"Ongoing","Main Street Family Pharmacy, LLC","Newbern","TN","US","Voluntary: Firm Initiated","Telephone","nationwide, specifically: AK, AL, AZ, CA, CO, CT, DC, FL, GA, HI, IL, IN, KS, KY, LA, MA, MD, MN, MO, MS, NC, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, SC, TN, TX, UT, VA, WA, WI, and WV","D-278-2014","Class II","TCA 20% 30ml vial, Main Street Compounding Pharmacy, 126 East Main Street, Newbern, TN 38059, 888-658-6200","all codes distributed prior to and including 05/23/2013",".","1 unit","The firm received seven reports of adverse reactions in the form of skin abscesses potentially linked to compounded preservative-free methylprednisolone 80mg/ml 10 ml vials. ",5/28/2013,"05/28/2013",12/11/2013,"12/11/2013"
"Drugs",65479,"Ongoing","Main Street Family Pharmacy, LLC","Newbern","TN","US","Voluntary: Firm Initiated","Telephone","nationwide, specifically: AK, AL, AZ, CA, CO, CT, DC, FL, GA, HI, IL, IN, KS, KY, LA, MA, MD, MN, MO, MS, NC, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, SC, TN, TX, UT, VA, WA, WI, and WV","D-283-2014","Class II","Testosterone Cypionate/Propionate 250mg/ml 10ml via, Main Street Compounding Pharmacy, 126 East Main Street, Newbern, TN 38059, 888-658-6200","all codes distributed prior to and including 05/23/2013",".","62 vials","The firm received seven reports of adverse reactions in the form of skin abscesses potentially linked to compounded preservative-free methylprednisolone 80mg/ml 10 ml vials. ",5/28/2013,"05/28/2013",12/11/2013,"12/11/2013"
"Drugs",65479,"Ongoing","Main Street Family Pharmacy, LLC","Newbern","TN","US","Voluntary: Firm Initiated","Telephone","nationwide, specifically: AK, AL, AZ, CA, CO, CT, DC, FL, GA, HI, IL, IN, KS, KY, LA, MA, MD, MN, MO, MS, NC, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, SC, TN, TX, UT, VA, WA, WI, and WV","D-227-2014","Class II","Mic 25/50/50 30ml, Main Street Compounding Pharmacy, 126 East Main Street, Newbern, TN 38059, 888-658-6200","all codes distributed prior to and including 05/23/2013",".","6 units","The firm received seven reports of adverse reactions in the form of skin abscesses potentially linked to compounded preservative-free methylprednisolone 80mg/ml 10 ml vials. ",5/28/2013,"05/28/2013",12/11/2013,"12/11/2013"
"Drugs",65479,"Ongoing","Main Street Family Pharmacy, LLC","Newbern","TN","US","Voluntary: Firm Initiated","Telephone","nationwide, specifically: AK, AL, AZ, CA, CO, CT, DC, FL, GA, HI, IL, IN, KS, KY, LA, MA, MD, MN, MO, MS, NC, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, SC, TN, TX, UT, VA, WA, WI, and WV","D-180-2014","Class II","Lipotropic (Getwell), Main Street Compounding Pharmacy, 126 East Main Street, Newbern, TN 38059, 888-658-6200","all codes distributed prior to and including 05/23/2013",".","16 units","The firm received seven reports of adverse reactions in the form of skin abscesses potentially linked to compounded preservative-free methylprednisolone 80mg/ml 10 ml vials. ",5/28/2013,"05/28/2013",12/11/2013,"12/11/2013"
"Drugs",65479,"Ongoing","Main Street Family Pharmacy, LLC","Newbern","TN","US","Voluntary: Firm Initiated","Telephone","nationwide, specifically: AK, AL, AZ, CA, CO, CT, DC, FL, GA, HI, IL, IN, KS, KY, LA, MA, MD, MN, MO, MS, NC, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, SC, TN, TX, UT, VA, WA, WI, and WV","D-183-2014","Class II","Lipotropic 10ml with B-12 and L- Carnitine, Main Street Compounding Pharmacy, 126 East Main Street, Newbern, TN 38059, 888-658-6200","all codes distributed prior to and including 05/23/2013",".","1 unit","The firm received seven reports of adverse reactions in the form of skin abscesses potentially linked to compounded preservative-free methylprednisolone 80mg/ml 10 ml vials. ",5/28/2013,"05/28/2013",12/11/2013,"12/11/2013"
"Drugs",65479,"Ongoing","Main Street Family Pharmacy, LLC","Newbern","TN","US","Voluntary: Firm Initiated","Telephone","nationwide, specifically: AK, AL, AZ, CA, CO, CT, DC, FL, GA, HI, IL, IN, KS, KY, LA, MA, MD, MN, MO, MS, NC, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, SC, TN, TX, UT, VA, WA, WI, and WV","D-113-2014","Class II","HCG 175 iu prefilled syringes, Main Street Compounding Pharmacy, 126 East Main Street, Newbern, TN 38059, 888-658-6200","all codes distributed prior to and including 05/23/2013",".","4738 units","The firm received seven reports of adverse reactions in the form of skin abscesses potentially linked to compounded preservative-free methylprednisolone 80mg/ml 10 ml vials. ",5/28/2013,"05/28/2013",12/11/2013,"12/11/2013"
"Drugs",65479,"Ongoing","Main Street Family Pharmacy, LLC","Newbern","TN","US","Voluntary: Firm Initiated","Telephone","nationwide, specifically: AK, AL, AZ, CA, CO, CT, DC, FL, GA, HI, IL, IN, KS, KY, LA, MA, MD, MN, MO, MS, NC, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, SC, TN, TX, UT, VA, WA, WI, and WV","D-060-2014","Class II","Betamethasone 9mg, Main Street Compounding Pharmacy, 126 East Main Street, Newbern, TN 38059, 888-658-6200","all codes distributed prior to and including 05/23/2013",".","12 units","The firm received seven reports of adverse reactions in the form of skin abscesses potentially linked to compounded preservative-free methylprednisolone 80mg/ml 10 ml vials. ",5/28/2013,"05/28/2013",12/11/2013,"12/11/2013"
"Drugs",65479,"Ongoing","Main Street Family Pharmacy, LLC","Newbern","TN","US","Voluntary: Firm Initiated","Telephone","nationwide, specifically: AK, AL, AZ, CA, CO, CT, DC, FL, GA, HI, IL, IN, KS, KY, LA, MA, MD, MN, MO, MS, NC, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, SC, TN, TX, UT, VA, WA, WI, and WV","D-255-2014","Class II","Pontocaine 2% 4 oz, Main Street Compounding Pharmacy, 126 East Main Street, Newbern, TN 38059, 888-658-6200","all codes distributed prior to and including 05/23/2013",".","10 units","The firm received seven reports of adverse reactions in the form of skin abscesses potentially linked to compounded preservative-free methylprednisolone 80mg/ml 10 ml vials. ",5/28/2013,"05/28/2013",12/11/2013,"12/11/2013"
"Drugs",65479,"Ongoing","Main Street Family Pharmacy, LLC","Newbern","TN","US","Voluntary: Firm Initiated","Telephone","nationwide, specifically: AK, AL, AZ, CA, CO, CT, DC, FL, GA, HI, IL, IN, KS, KY, LA, MA, MD, MN, MO, MS, NC, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, SC, TN, TX, UT, VA, WA, WI, and WV","D-182-2014","Class II","Lipotropic 10ml, Main Street Compounding Pharmacy, 126 East Main Street, Newbern, TN 38059, 888-658-6200","all codes distributed prior to and including 05/23/2013",".","2 units","The firm received seven reports of adverse reactions in the form of skin abscesses potentially linked to compounded preservative-free methylprednisolone 80mg/ml 10 ml vials. ",5/28/2013,"05/28/2013",12/11/2013,"12/11/2013"
"Drugs",65479,"Ongoing","Main Street Family Pharmacy, LLC","Newbern","TN","US","Voluntary: Firm Initiated","Telephone","nationwide, specifically: AK, AL, AZ, CA, CO, CT, DC, FL, GA, HI, IL, IN, KS, KY, LA, MA, MD, MN, MO, MS, NC, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, SC, TN, TX, UT, VA, WA, WI, and WV","D-110-2014","Class II","HCG 15,000u, Main Street Compounding Pharmacy, 126 East Main Street, Newbern, TN 38059, 888-658-6200","all codes distributed prior to and including 05/23/2013",".","300 units","The firm received seven reports of adverse reactions in the form of skin abscesses potentially linked to compounded preservative-free methylprednisolone 80mg/ml 10 ml vials. ",5/28/2013,"05/28/2013",12/11/2013,"12/11/2013"
"Drugs",65479,"Ongoing","Main Street Family Pharmacy, LLC","Newbern","TN","US","Voluntary: Firm Initiated","Telephone","nationwide, specifically: AK, AL, AZ, CA, CO, CT, DC, FL, GA, HI, IL, IN, KS, KY, LA, MA, MD, MN, MO, MS, NC, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, SC, TN, TX, UT, VA, WA, WI, and WV","D-138-2014","Class II","HCG 360iu PFS, Main Street Compounding Pharmacy, 126 East Main Street, Newbern, TN 38059, 888-658-6200","all codes distributed prior to and including 05/23/2013",".","189 units","The firm received seven reports of adverse reactions in the form of skin abscesses potentially linked to compounded preservative-free methylprednisolone 80mg/ml 10 ml vials. ",5/28/2013,"05/28/2013",12/11/2013,"12/11/2013"
"Drugs",65479,"Ongoing","Main Street Family Pharmacy, LLC","Newbern","TN","US","Voluntary: Firm Initiated","Telephone","nationwide, specifically: AK, AL, AZ, CA, CO, CT, DC, FL, GA, HI, IL, IN, KS, KY, LA, MA, MD, MN, MO, MS, NC, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, SC, TN, TX, UT, VA, WA, WI, and WV","D-233-2014","Class II","Mic B-Complex 50ml, Main Street Compounding Pharmacy, 126 East Main Street, Newbern, TN 38059, 888-658-6200","all codes distributed prior to and including 05/23/2013",".","303 units","The firm received seven reports of adverse reactions in the form of skin abscesses potentially linked to compounded preservative-free methylprednisolone 80mg/ml 10 ml vials. ",5/28/2013,"05/28/2013",12/11/2013,"12/11/2013"
"Drugs",65479,"Ongoing","Main Street Family Pharmacy, LLC","Newbern","TN","US","Voluntary: Firm Initiated","Telephone","nationwide, specifically: AK, AL, AZ, CA, CO, CT, DC, FL, GA, HI, IL, IN, KS, KY, LA, MA, MD, MN, MO, MS, NC, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, SC, TN, TX, UT, VA, WA, WI, and WV","D-088-2014","Class II","Estradiol Pellet 50mg, Main Street Compounding Pharmacy, 126 East Main Street, Newbern, TN 38059, 888-658-6200","all codes distributed prior to and including 05/23/2013",".","4 units","The firm received seven reports of adverse reactions in the form of skin abscesses potentially linked to compounded preservative-free methylprednisolone 80mg/ml 10 ml vials. ",5/28/2013,"05/28/2013",12/11/2013,"12/11/2013"
"Drugs",65479,"Ongoing","Main Street Family Pharmacy, LLC","Newbern","TN","US","Voluntary: Firm Initiated","Telephone","nationwide, specifically: AK, AL, AZ, CA, CO, CT, DC, FL, GA, HI, IL, IN, KS, KY, LA, MA, MD, MN, MO, MS, NC, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, SC, TN, TX, UT, VA, WA, WI, and WV","D-310-2014","Class II","Tetracaine 2%/Pontocaine, 60ml Main Street Compounding Pharmacy, 126 East Main Street, Newbern, TN 38059, 888-658-6200","all codes distributed prior to and including 05/23/2013",".","5 units","The firm received seven reports of adverse reactions in the form of skin abscesses potentially linked to compounded preservative-free methylprednisolone 80mg/ml 10 ml vials. ",5/28/2013,"05/28/2013",12/11/2013,"12/11/2013"
"Drugs",65479,"Ongoing","Main Street Family Pharmacy, LLC","Newbern","TN","US","Voluntary: Firm Initiated","Telephone","nationwide, specifically: AK, AL, AZ, CA, CO, CT, DC, FL, GA, HI, IL, IN, KS, KY, LA, MA, MD, MN, MO, MS, NC, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, SC, TN, TX, UT, VA, WA, WI, and WV","D-308-2014","Class II","Testosterone Propionate. 100mg 10ml, Main Street Compounding Pharmacy, 126 East Main Street, Newbern, TN 38059, 888-658-6200","all codes distributed prior to and including 05/23/2013",".","80 units","The firm received seven reports of adverse reactions in the form of skin abscesses potentially linked to compounded preservative-free methylprednisolone 80mg/ml 10 ml vials. ",5/28/2013,"05/28/2013",12/11/2013,"12/11/2013"
"Drugs",65479,"Ongoing","Main Street Family Pharmacy, LLC","Newbern","TN","US","Voluntary: Firm Initiated","Telephone","nationwide, specifically: AK, AL, AZ, CA, CO, CT, DC, FL, GA, HI, IL, IN, KS, KY, LA, MA, MD, MN, MO, MS, NC, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, SC, TN, TX, UT, VA, WA, WI, and WV","D-223-2014","Class II","Methylprednisolone 80mg PF 1ml, Main Street Compounding Pharmacy, 126 East Main Street, Newbern, TN 38059, 888-658-6200","all codes distributed prior to and including 05/23/2013",".","2187 units","The firm received seven reports of adverse reactions in the form of skin abscesses potentially linked to compounded preservative-free methylprednisolone 80mg/ml 10 ml vials. ",5/28/2013,"05/28/2013",12/11/2013,"12/11/2013"
"Drugs",65479,"Ongoing","Main Street Family Pharmacy, LLC","Newbern","TN","US","Voluntary: Firm Initiated","Telephone","nationwide, specifically: AK, AL, AZ, CA, CO, CT, DC, FL, GA, HI, IL, IN, KS, KY, LA, MA, MD, MN, MO, MS, NC, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, SC, TN, TX, UT, VA, WA, WI, and WV","D-191-2014","Class II","MALE HCG PK 2nd month, Main Street Compounding Pharmacy, 126 East Main Street, Newbern, TN 38059, 888-658-6200","all codes distributed prior to and including 05/23/2013",".","21 units","The firm received seven reports of adverse reactions in the form of skin abscesses potentially linked to compounded preservative-free methylprednisolone 80mg/ml 10 ml vials. ",5/28/2013,"05/28/2013",12/11/2013,"12/11/2013"
"Drugs",65479,"Ongoing","Main Street Family Pharmacy, LLC","Newbern","TN","US","Voluntary: Firm Initiated","Telephone","nationwide, specifically: AK, AL, AZ, CA, CO, CT, DC, FL, GA, HI, IL, IN, KS, KY, LA, MA, MD, MN, MO, MS, NC, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, SC, TN, TX, UT, VA, WA, WI, and WV","D-225-2014","Class II","Methylprednisolone Acetate 80mg 1ml, Main Street Compounding Pharmacy, 126 East Main Street, Newbern, TN 38059, 888-658-6200","all codes distributed prior to and including 05/23/2013",".","22 units","The firm received seven reports of adverse reactions in the form of skin abscesses potentially linked to compounded preservative-free methylprednisolone 80mg/ml 10 ml vials. ",5/28/2013,"05/28/2013",12/11/2013,"12/11/2013"
"Drugs",65479,"Ongoing","Main Street Family Pharmacy, LLC","Newbern","TN","US","Voluntary: Firm Initiated","Telephone","nationwide, specifically: AK, AL, AZ, CA, CO, CT, DC, FL, GA, HI, IL, IN, KS, KY, LA, MA, MD, MN, MO, MS, NC, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, SC, TN, TX, UT, VA, WA, WI, and WV","D-176-2014","Class II","Lipotonix Plus 30ml, Main Street Compounding Pharmacy, 126 East Main Street, Newbern, TN 38059, 888-658-6200","all codes distributed prior to and including 05/23/2013",".","1505 units","The firm received seven reports of adverse reactions in the form of skin abscesses potentially linked to compounded preservative-free methylprednisolone 80mg/ml 10 ml vials. ",5/28/2013,"05/28/2013",12/11/2013,"12/11/2013"
"Drugs",65479,"Ongoing","Main Street Family Pharmacy, LLC","Newbern","TN","US","Voluntary: Firm Initiated","Telephone","nationwide, specifically: AK, AL, AZ, CA, CO, CT, DC, FL, GA, HI, IL, IN, KS, KY, LA, MA, MD, MN, MO, MS, NC, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, SC, TN, TX, UT, VA, WA, WI, and WV","D-210-2014","Class I","Methylprednisolone 100mg/ml, 10ml, Main Street Compounding Pharmacy, 126 East Main Street, Newbern, TN 38059, 888-658-6200","lot# 011213dan",".","697 units","The firm received seven reports of adverse reactions in the form of skin abscesses potentially linked to compounded preservative-free methylprednisolone 80mg/ml 10 ml vials. ",5/28/2013,"05/28/2013",12/11/2013,"12/11/2013"
"Drugs",65479,"Ongoing","Main Street Family Pharmacy, LLC","Newbern","TN","US","Voluntary: Firm Initiated","Telephone","nationwide, specifically: AK, AL, AZ, CA, CO, CT, DC, FL, GA, HI, IL, IN, KS, KY, LA, MA, MD, MN, MO, MS, NC, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, SC, TN, TX, UT, VA, WA, WI, and WV","D-111-2014","Class II","HCG 15000u w/b-12, Main Street Compounding Pharmacy, 126 East Main Street, Newbern, TN 38059, 888-658-6200","all codes distributed prior to and including 05/23/2013",".","1 unit","The firm received seven reports of adverse reactions in the form of skin abscesses potentially linked to compounded preservative-free methylprednisolone 80mg/ml 10 ml vials. ",5/28/2013,"05/28/2013",12/11/2013,"12/11/2013"
"Drugs",65479,"Ongoing","Main Street Family Pharmacy, LLC","Newbern","TN","US","Voluntary: Firm Initiated","Telephone","nationwide, specifically: AK, AL, AZ, CA, CO, CT, DC, FL, GA, HI, IL, IN, KS, KY, LA, MA, MD, MN, MO, MS, NC, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, SC, TN, TX, UT, VA, WA, WI, and WV","D-179-2014","Class II","Lipotonix Plus-Mic B complex, Main Street Compounding Pharmacy, 126 East Main Street, Newbern, TN 38059, 888-658-6200","all codes distributed prior to and including 05/23/2013",".","211 units","The firm received seven reports of adverse reactions in the form of skin abscesses potentially linked to compounded preservative-free methylprednisolone 80mg/ml 10 ml vials. ",5/28/2013,"05/28/2013",12/11/2013,"12/11/2013"
"Drugs",65479,"Ongoing","Main Street Family Pharmacy, LLC","Newbern","TN","US","Voluntary: Firm Initiated","Telephone","nationwide, specifically: AK, AL, AZ, CA, CO, CT, DC, FL, GA, HI, IL, IN, KS, KY, LA, MA, MD, MN, MO, MS, NC, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, SC, TN, TX, UT, VA, WA, WI, and WV","D-275-2014","Class II","Taper A prefilled syringes, Main Street Compounding Pharmacy, 126 East Main Street, Newbern, TN 38059, 888-658-6200","all codes distributed prior to and including 05/23/2013",".","61 units","The firm received seven reports of adverse reactions in the form of skin abscesses potentially linked to compounded preservative-free methylprednisolone 80mg/ml 10 ml vials. ",5/28/2013,"05/28/2013",12/11/2013,"12/11/2013"
"Drugs",65479,"Ongoing","Main Street Family Pharmacy, LLC","Newbern","TN","US","Voluntary: Firm Initiated","Telephone","nationwide, specifically: AK, AL, AZ, CA, CO, CT, DC, FL, GA, HI, IL, IN, KS, KY, LA, MA, MD, MN, MO, MS, NC, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, SC, TN, TX, UT, VA, WA, WI, and WV","D-104-2014","Class II","HCG 10000u, Main Street Compounding Pharmacy, 126 East Main Street, Newbern, TN 38059, 888-658-6200","all codes distributed prior to and including 05/23/2013",".","180 units","The firm received seven reports of adverse reactions in the form of skin abscesses potentially linked to compounded preservative-free methylprednisolone 80mg/ml 10 ml vials. ",5/28/2013,"05/28/2013",12/11/2013,"12/11/2013"
"Drugs",65479,"Ongoing","Main Street Family Pharmacy, LLC","Newbern","TN","US","Voluntary: Firm Initiated","Telephone","nationwide, specifically: AK, AL, AZ, CA, CO, CT, DC, FL, GA, HI, IL, IN, KS, KY, LA, MA, MD, MN, MO, MS, NC, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, SC, TN, TX, UT, VA, WA, WI, and WV","D-128-2014","Class II","HCG 275 iu prefilled syringes, Main Street Compounding Pharmacy, 126 East Main Street, Newbern, TN 38059, 888-658-6200","all codes distributed prior to and including 05/23/2013",".","165 units","The firm received seven reports of adverse reactions in the form of skin abscesses potentially linked to compounded preservative-free methylprednisolone 80mg/ml 10 ml vials. ",5/28/2013,"05/28/2013",12/11/2013,"12/11/2013"
"Drugs",65479,"Ongoing","Main Street Family Pharmacy, LLC","Newbern","TN","US","Voluntary: Firm Initiated","Telephone","nationwide, specifically: AK, AL, AZ, CA, CO, CT, DC, FL, GA, HI, IL, IN, KS, KY, LA, MA, MD, MN, MO, MS, NC, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, SC, TN, TX, UT, VA, WA, WI, and WV","D-062-2014","Class II","Betamethasone 10mg 10ml, Main Street Compounding Pharmacy, 126 East Main Street, Newbern, TN 38059, 888-658-6200","all codes distributed prior to and including 05/23/2013",".","10 units","The firm received seven reports of adverse reactions in the form of skin abscesses potentially linked to compounded preservative-free methylprednisolone 80mg/ml 10 ml vials. ",5/28/2013,"05/28/2013",12/11/2013,"12/11/2013"
"Drugs",65479,"Ongoing","Main Street Family Pharmacy, LLC","Newbern","TN","US","Voluntary: Firm Initiated","Telephone","nationwide, specifically: AK, AL, AZ, CA, CO, CT, DC, FL, GA, HI, IL, IN, KS, KY, LA, MA, MD, MN, MO, MS, NC, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, SC, TN, TX, UT, VA, WA, WI, and WV","D-201-2014","Class II","Medroxyprogesterone 150mg 1ml, Main Street Compounding Pharmacy, 126 East Main Street, Newbern, TN 38059, 888-658-6200","all codes distributed prior to and including 05/23/2013",".","1131 units","The firm received seven reports of adverse reactions in the form of skin abscesses potentially linked to compounded preservative-free methylprednisolone 80mg/ml 10 ml vials. ",5/28/2013,"05/28/2013",12/11/2013,"12/11/2013"
"Drugs",65479,"Ongoing","Main Street Family Pharmacy, LLC","Newbern","TN","US","Voluntary: Firm Initiated","Telephone","nationwide, specifically: AK, AL, AZ, CA, CO, CT, DC, FL, GA, HI, IL, IN, KS, KY, LA, MA, MD, MN, MO, MS, NC, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, SC, TN, TX, UT, VA, WA, WI, and WV","D-259-2014","Class II","Pre-menopausal HCG pack, Main Street Compounding Pharmacy, 126 East Main Street, Newbern, TN 38059, 888-658-6200","all codes distributed prior to and including 05/23/2013",".","371 units","The firm received seven reports of adverse reactions in the form of skin abscesses potentially linked to compounded preservative-free methylprednisolone 80mg/ml 10 ml vials. ",5/28/2013,"05/28/2013",12/11/2013,"12/11/2013"
"Drugs",65479,"Ongoing","Main Street Family Pharmacy, LLC","Newbern","TN","US","Voluntary: Firm Initiated","Telephone","nationwide, specifically: AK, AL, AZ, CA, CO, CT, DC, FL, GA, HI, IL, IN, KS, KY, LA, MA, MD, MN, MO, MS, NC, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, SC, TN, TX, UT, VA, WA, WI, and WV","D-240-2014","Class II","Mic Ultra-Sulfur Free 10ml, Main Street Compounding Pharmacy, 126 East Main Street, Newbern, TN 38059, 888-658-6200","all codes distributed prior to and including 05/23/2013",".","1 unit","The firm received seven reports of adverse reactions in the form of skin abscesses potentially linked to compounded preservative-free methylprednisolone 80mg/ml 10 ml vials. ",5/28/2013,"05/28/2013",12/11/2013,"12/11/2013"
"Drugs",65479,"Ongoing","Main Street Family Pharmacy, LLC","Newbern","TN","US","Voluntary: Firm Initiated","Telephone","nationwide, specifically: AK, AL, AZ, CA, CO, CT, DC, FL, GA, HI, IL, IN, KS, KY, LA, MA, MD, MN, MO, MS, NC, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, SC, TN, TX, UT, VA, WA, WI, and WV","D-319-2014","Class II","Tri-Mix SS Pap 30mg, Phen 1mg, PGE1 10mcg 5ml, Main Street Compounding Pharmacy, 126 East Main Street, Newbern, TN 38059, 888-658-6200","all codes distributed prior to and including 05/23/2013",".","1 unit","The firm received seven reports of adverse reactions in the form of skin abscesses potentially linked to compounded preservative-free methylprednisolone 80mg/ml 10 ml vials. ",5/28/2013,"05/28/2013",12/11/2013,"12/11/2013"
"Drugs",65479,"Ongoing","Main Street Family Pharmacy, LLC","Newbern","TN","US","Voluntary: Firm Initiated","Telephone","nationwide, specifically: AK, AL, AZ, CA, CO, CT, DC, FL, GA, HI, IL, IN, KS, KY, LA, MA, MD, MN, MO, MS, NC, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, SC, TN, TX, UT, VA, WA, WI, and WV","D-222-2014","Class II","Methylprednisolone 80mg 10ml, Main Street Compounding Pharmacy, 126 East Main Street, Newbern, TN 38059, 888-658-6200","all codes distributed prior to and including 05/23/2013",".","91 units","The firm received seven reports of adverse reactions in the form of skin abscesses potentially linked to compounded preservative-free methylprednisolone 80mg/ml 10 ml vials. ",5/28/2013,"05/28/2013",12/11/2013,"12/11/2013"
"Drugs",65479,"Ongoing","Main Street Family Pharmacy, LLC","Newbern","TN","US","Voluntary: Firm Initiated","Telephone","nationwide, specifically: AK, AL, AZ, CA, CO, CT, DC, FL, GA, HI, IL, IN, KS, KY, LA, MA, MD, MN, MO, MS, NC, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, SC, TN, TX, UT, VA, WA, WI, and WV","D-212-2014","Class II","Methylprednisolone 20mg PF 5ml, Main Street Compounding Pharmacy, 126 East Main Street, Newbern, TN 38059, 888-658-6200","all codes distributed prior to and including 05/23/2013",".","40 units","The firm received seven reports of adverse reactions in the form of skin abscesses potentially linked to compounded preservative-free methylprednisolone 80mg/ml 10 ml vials. ",5/28/2013,"05/28/2013",12/11/2013,"12/11/2013"
"Drugs",65479,"Ongoing","Main Street Family Pharmacy, LLC","Newbern","TN","US","Voluntary: Firm Initiated","Telephone","nationwide, specifically: AK, AL, AZ, CA, CO, CT, DC, FL, GA, HI, IL, IN, KS, KY, LA, MA, MD, MN, MO, MS, NC, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, SC, TN, TX, UT, VA, WA, WI, and WV","D-024-2014","Class II","17-P 1ml, Main Street Compounding Pharmacy, 126 East Main Street, Newbern, TN 38059, 888-658-6200","all codes distributed prior to and including 05/23/2013",".","875 units","The firm received seven reports of adverse reactions in the form of skin abscesses potentially linked to compounded preservative-free methylprednisolone 80mg/ml 10 ml vials. ",5/28/2013,"05/28/2013",12/11/2013,"12/11/2013"
"Drugs",65479,"Ongoing","Main Street Family Pharmacy, LLC","Newbern","TN","US","Voluntary: Firm Initiated","Telephone","nationwide, specifically: AK, AL, AZ, CA, CO, CT, DC, FL, GA, HI, IL, IN, KS, KY, LA, MA, MD, MN, MO, MS, NC, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, SC, TN, TX, UT, VA, WA, WI, and WV","D-133-2014","Class II","HCG 310 iu prefilled syringes, Main Street Compounding Pharmacy, 126 East Main Street, Newbern, TN 38059, 888-658-6200","all codes distributed prior to and including 05/23/2013",".","7080 units","The firm received seven reports of adverse reactions in the form of skin abscesses potentially linked to compounded preservative-free methylprednisolone 80mg/ml 10 ml vials. ",5/28/2013,"05/28/2013",12/11/2013,"12/11/2013"
"Drugs",65479,"Ongoing","Main Street Family Pharmacy, LLC","Newbern","TN","US","Voluntary: Firm Initiated","Telephone","nationwide, specifically: AK, AL, AZ, CA, CO, CT, DC, FL, GA, HI, IL, IN, KS, KY, LA, MA, MD, MN, MO, MS, NC, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, SC, TN, TX, UT, VA, WA, WI, and WV","D-153-2014","Class II","Hydrogen Peroxide 3% 30ml (PF), Main Street Compounding Pharmacy, 126 East Main Street, Newbern, TN 38059, 888-658-6200","all codes distributed prior to and including 05/23/2013",".","7 units","The firm received seven reports of adverse reactions in the form of skin abscesses potentially linked to compounded preservative-free methylprednisolone 80mg/ml 10 ml vials. ",5/28/2013,"05/28/2013",12/11/2013,"12/11/2013"
"Drugs",65479,"Ongoing","Main Street Family Pharmacy, LLC","Newbern","TN","US","Voluntary: Firm Initiated","Telephone","nationwide, specifically: AK, AL, AZ, CA, CO, CT, DC, FL, GA, HI, IL, IN, KS, KY, LA, MA, MD, MN, MO, MS, NC, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, SC, TN, TX, UT, VA, WA, WI, and WV","D-220-2014","Class I","Methylprednisolone 80mg/ml (PF) 10ml, Main Street Compounding Pharmacy, 126 East Main Street, Newbern, TN 38059, 888-658-6200","Lot# 012813dan, 011413dan, 010913dan",".","1312 units","The firm received seven reports of adverse reactions in the form of skin abscesses potentially linked to compounded preservative-free methylprednisolone 80mg/ml 10 ml vials. ",5/28/2013,"05/28/2013",12/11/2013,"12/11/2013"
"Drugs",65479,"Ongoing","Main Street Family Pharmacy, LLC","Newbern","TN","US","Voluntary: Firm Initiated","Telephone","nationwide, specifically: AK, AL, AZ, CA, CO, CT, DC, FL, GA, HI, IL, IN, KS, KY, LA, MA, MD, MN, MO, MS, NC, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, SC, TN, TX, UT, VA, WA, WI, and WV","D-291-2014","Class II","Testosterone Cypionate 100mg/ml, Main Street Compounding Pharmacy, 126 East Main Street, Newbern, TN 38059, 888-658-6200","distributed prior to and including 05/23/2013",".","2 units","The firm received seven reports of adverse reactions in the form of skin abscesses potentially linked to compounded preservative-free methylprednisolone 80mg/ml 10 ml vials. ",5/28/2013,"05/28/2013",12/11/2013,"12/11/2013"
"Drugs",65479,"Ongoing","Main Street Family Pharmacy, LLC","Newbern","TN","US","Voluntary: Firm Initiated","Telephone","nationwide, specifically: AK, AL, AZ, CA, CO, CT, DC, FL, GA, HI, IL, IN, KS, KY, LA, MA, MD, MN, MO, MS, NC, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, SC, TN, TX, UT, VA, WA, WI, and WV","D-215-2014","Class II","Methylprednisolone 40mg PF 10ml, Main Street Compounding Pharmacy, 126 East Main Street, Newbern, TN 38059, 888-658-6200","all codes distributed prior to and including 05/23/2013",".","974 units","The firm received seven reports of adverse reactions in the form of skin abscesses potentially linked to compounded preservative-free methylprednisolone 80mg/ml 10 ml vials. ",5/28/2013,"05/28/2013",12/11/2013,"12/11/2013"
"Drugs",65479,"Ongoing","Main Street Family Pharmacy, LLC","Newbern","TN","US","Voluntary: Firm Initiated","Telephone","nationwide, specifically: AK, AL, AZ, CA, CO, CT, DC, FL, GA, HI, IL, IN, KS, KY, LA, MA, MD, MN, MO, MS, NC, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, SC, TN, TX, UT, VA, WA, WI, and WV","D-230-2014","Class II","Mic 30ml, Main Street Compounding Pharmacy, 126 East Main Street, Newbern, TN 38059, 888-658-6200","all codes distributed prior to and including 05/23/2013",".","16 units","The firm received seven reports of adverse reactions in the form of skin abscesses potentially linked to compounded preservative-free methylprednisolone 80mg/ml 10 ml vials. ",5/28/2013,"05/28/2013",12/11/2013,"12/11/2013"
"Drugs",65479,"Ongoing","Main Street Family Pharmacy, LLC","Newbern","TN","US","Voluntary: Firm Initiated","Telephone","nationwide, specifically: AK, AL, AZ, CA, CO, CT, DC, FL, GA, HI, IL, IN, KS, KY, LA, MA, MD, MN, MO, MS, NC, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, SC, TN, TX, UT, VA, WA, WI, and WV","D-084-2014","Class II","EDTA 3% 30ml, Main Street Compounding Pharmacy, 126 East Main Street, Newbern, TN 38059, 888-658-6200","all codes distributed prior to and including 05/23/2013",".","1 unit","The firm received seven reports of adverse reactions in the form of skin abscesses potentially linked to compounded preservative-free methylprednisolone 80mg/ml 10 ml vials. ",5/28/2013,"05/28/2013",12/11/2013,"12/11/2013"
"Drugs",65479,"Ongoing","Main Street Family Pharmacy, LLC","Newbern","TN","US","Voluntary: Firm Initiated","Telephone","nationwide, specifically: AK, AL, AZ, CA, CO, CT, DC, FL, GA, HI, IL, IN, KS, KY, LA, MA, MD, MN, MO, MS, NC, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, SC, TN, TX, UT, VA, WA, WI, and WV","D-296-2014","Class II","Testosterone Pellet 112mg, Main Street Compounding Pharmacy, 126 East Main Street, Newbern, TN 38059, 888-658-6200","distributed prior to and including 05/23/2013",".","5 units","The firm received seven reports of adverse reactions in the form of skin abscesses potentially linked to compounded preservative-free methylprednisolone 80mg/ml 10 ml vials. ",5/28/2013,"05/28/2013",12/11/2013,"12/11/2013"
"Drugs",65479,"Ongoing","Main Street Family Pharmacy, LLC","Newbern","TN","US","Voluntary: Firm Initiated","Telephone","nationwide, specifically: AK, AL, AZ, CA, CO, CT, DC, FL, GA, HI, IL, IN, KS, KY, LA, MA, MD, MN, MO, MS, NC, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, SC, TN, TX, UT, VA, WA, WI, and WV","D-083-2014","Class II","EDTA 150mg/ml 100ml, Main Street Compounding Pharmacy, 126 East Main Street, Newbern, TN 38059, 888-658-6200","all codes distributed prior to and including 05/23/2013",".","25 units","The firm received seven reports of adverse reactions in the form of skin abscesses potentially linked to compounded preservative-free methylprednisolone 80mg/ml 10 ml vials. ",5/28/2013,"05/28/2013",12/11/2013,"12/11/2013"
"Drugs",65479,"Ongoing","Main Street Family Pharmacy, LLC","Newbern","TN","US","Voluntary: Firm Initiated","Telephone","nationwide, specifically: AK, AL, AZ, CA, CO, CT, DC, FL, GA, HI, IL, IN, KS, KY, LA, MA, MD, MN, MO, MS, NC, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, SC, TN, TX, UT, VA, WA, WI, and WV","D-106-2014","Class II","HCG 11,000U, Main Street Compounding Pharmacy, 126 East Main Street, Newbern, TN 38059, 888-658-6200","all codes distributed prior to and including 05/23/2013",".","1554 units","The firm received seven reports of adverse reactions in the form of skin abscesses potentially linked to compounded preservative-free methylprednisolone 80mg/ml 10 ml vials. ",5/28/2013,"05/28/2013",12/11/2013,"12/11/2013"
"Drugs",65479,"Ongoing","Main Street Family Pharmacy, LLC","Newbern","TN","US","Voluntary: Firm Initiated","Telephone","nationwide, specifically: AK, AL, AZ, CA, CO, CT, DC, FL, GA, HI, IL, IN, KS, KY, LA, MA, MD, MN, MO, MS, NC, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, SC, TN, TX, UT, VA, WA, WI, and WV","D-262-2014","Class II","Sermorelin 15mg, Main Street Compounding Pharmacy, 126 East Main Street, Newbern, TN 38059, 888-658-6200","all codes distributed prior to and including 05/23/2013",".","12 units","The firm received seven reports of adverse reactions in the form of skin abscesses potentially linked to compounded preservative-free methylprednisolone 80mg/ml 10 ml vials. ",5/28/2013,"05/28/2013",12/11/2013,"12/11/2013"
"Drugs",65479,"Ongoing","Main Street Family Pharmacy, LLC","Newbern","TN","US","Voluntary: Firm Initiated","Telephone","nationwide, specifically: AK, AL, AZ, CA, CO, CT, DC, FL, GA, HI, IL, IN, KS, KY, LA, MA, MD, MN, MO, MS, NC, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, SC, TN, TX, UT, VA, WA, WI, and WV","D-029-2014","Class II","Adenosine Monophosphate, 50mg/ml 30ml, Main Street Compounding Pharmacy, 126 East Main Street, Newbern, TN 38059, 888-658-6200","all codes distributed prior to and including 05/23/2013",".","15 units","The firm received seven reports of adverse reactions in the form of skin abscesses potentially linked to compounded preservative-free methylprednisolone 80mg/ml 10 ml vials. ",5/28/2013,"05/28/2013",12/11/2013,"12/11/2013"
"Drugs",65479,"Ongoing","Main Street Family Pharmacy, LLC","Newbern","TN","US","Voluntary: Firm Initiated","Telephone","nationwide, specifically: AK, AL, AZ, CA, CO, CT, DC, FL, GA, HI, IL, IN, KS, KY, LA, MA, MD, MN, MO, MS, NC, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, SC, TN, TX, UT, VA, WA, WI, and WV","D-042-2014","Class II","B-12 (compounded) 30ml, Main Street Compounding Pharmacy, 126 East Main Street, Newbern, TN 38059, 888-658-6200","all codes distributed prior to and including 05/23/2013",".","2157 units","The firm received seven reports of adverse reactions in the form of skin abscesses potentially linked to compounded preservative-free methylprednisolone 80mg/ml 10 ml vials. ",5/28/2013,"05/28/2013",12/11/2013,"12/11/2013"
"Drugs",65479,"Ongoing","Main Street Family Pharmacy, LLC","Newbern","TN","US","Voluntary: Firm Initiated","Telephone","nationwide, specifically: AK, AL, AZ, CA, CO, CT, DC, FL, GA, HI, IL, IN, KS, KY, LA, MA, MD, MN, MO, MS, NC, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, SC, TN, TX, UT, VA, WA, WI, and WV","D-096-2014","Class II","G-A-C Amino Cocktail 30ml, Main Street Compounding Pharmacy, 126 East Main Street, Newbern, TN 38059, 888-658-6200","all codes distributed prior to and including 05/23/2013",".","8 units","The firm received seven reports of adverse reactions in the form of skin abscesses potentially linked to compounded preservative-free methylprednisolone 80mg/ml 10 ml vials. ",5/28/2013,"05/28/2013",12/11/2013,"12/11/2013"
"Drugs",65479,"Ongoing","Main Street Family Pharmacy, LLC","Newbern","TN","US","Voluntary: Firm Initiated","Telephone","nationwide, specifically: AK, AL, AZ, CA, CO, CT, DC, FL, GA, HI, IL, IN, KS, KY, LA, MA, MD, MN, MO, MS, NC, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, SC, TN, TX, UT, VA, WA, WI, and WV","D-091-2014","Class II","Estradiol Pellets 12mg, Main Street Compounding Pharmacy, 126 East Main Street, Newbern, TN 38059, 888-658-6200","all codes distributed prior to and including 05/23/2013",".","42 units","The firm received seven reports of adverse reactions in the form of skin abscesses potentially linked to compounded preservative-free methylprednisolone 80mg/ml 10 ml vials. ",5/28/2013,"05/28/2013",12/11/2013,"12/11/2013"
"Drugs",65479,"Ongoing","Main Street Family Pharmacy, LLC","Newbern","TN","US","Voluntary: Firm Initiated","Telephone","nationwide, specifically: AK, AL, AZ, CA, CO, CT, DC, FL, GA, HI, IL, IN, KS, KY, LA, MA, MD, MN, MO, MS, NC, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, SC, TN, TX, UT, VA, WA, WI, and WV","D-206-2014","Class II","Methylcobalamin 1000mcg/ml 30ml, Main Street Compounding Pharmacy, 126 East Main Street, Newbern, TN 38059, 888-658-6200","all codes distributed prior to and including 05/23/2013",".","4 units","The firm received seven reports of adverse reactions in the form of skin abscesses potentially linked to compounded preservative-free methylprednisolone 80mg/ml 10 ml vials. ",5/28/2013,"05/28/2013",12/11/2013,"12/11/2013"
"Drugs",65479,"Ongoing","Main Street Family Pharmacy, LLC","Newbern","TN","US","Voluntary: Firm Initiated","Telephone","nationwide, specifically: AK, AL, AZ, CA, CO, CT, DC, FL, GA, HI, IL, IN, KS, KY, LA, MA, MD, MN, MO, MS, NC, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, SC, TN, TX, UT, VA, WA, WI, and WV","D-238-2014","Class II","Mic Ultra 50ml- Sulfur Free, Main Street Compounding Pharmacy, 126 East Main Street, Newbern, TN 38059, 888-658-6200","all codes distributed prior to and including 05/23/2013",".","81 units","The firm received seven reports of adverse reactions in the form of skin abscesses potentially linked to compounded preservative-free methylprednisolone 80mg/ml 10 ml vials. ",5/28/2013,"05/28/2013",12/11/2013,"12/11/2013"
"Drugs",65479,"Ongoing","Main Street Family Pharmacy, LLC","Newbern","TN","US","Voluntary: Firm Initiated","Telephone","nationwide, specifically: AK, AL, AZ, CA, CO, CT, DC, FL, GA, HI, IL, IN, KS, KY, LA, MA, MD, MN, MO, MS, NC, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, SC, TN, TX, UT, VA, WA, WI, and WV","D-297-2014","Class II","Testosterone Pellet 12.5mg, Main Street Compounding Pharmacy, 126 East Main Street, Newbern, TN 38059, 888-658-6200","distributed prior to and including 05/23/2013",".","16 units","The firm received seven reports of adverse reactions in the form of skin abscesses potentially linked to compounded preservative-free methylprednisolone 80mg/ml 10 ml vials. ",5/28/2013,"05/28/2013",12/11/2013,"12/11/2013"
"Drugs",65479,"Ongoing","Main Street Family Pharmacy, LLC","Newbern","TN","US","Voluntary: Firm Initiated","Telephone","nationwide, specifically: AK, AL, AZ, CA, CO, CT, DC, FL, GA, HI, IL, IN, KS, KY, LA, MA, MD, MN, MO, MS, NC, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, SC, TN, TX, UT, VA, WA, WI, and WV","D-080-2014","Class II","Double Strength PGE1 40mcg 2ml, Main Street Compounding Pharmacy, 126 East Main Street, Newbern, TN 38059, 888-658-6200","all codes distributed prior to and including 05/23/2013",".","1 unit","The firm received seven reports of adverse reactions in the form of skin abscesses potentially linked to compounded preservative-free methylprednisolone 80mg/ml 10 ml vials. ",5/28/2013,"05/28/2013",12/11/2013,"12/11/2013"
"Drugs",65479,"Ongoing","Main Street Family Pharmacy, LLC","Newbern","TN","US","Voluntary: Firm Initiated","Telephone","nationwide, specifically: AK, AL, AZ, CA, CO, CT, DC, FL, GA, HI, IL, IN, KS, KY, LA, MA, MD, MN, MO, MS, NC, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, SC, TN, TX, UT, VA, WA, WI, and WV","D-304-2014","Class II","Testosterone Pellets 25mg, Main Street Compounding Pharmacy, 126 East Main Street, Newbern, TN 38059, 888-658-6200","all codes distributed prior to and including 05/23/2013",".","107 units","The firm received seven reports of adverse reactions in the form of skin abscesses potentially linked to compounded preservative-free methylprednisolone 80mg/ml 10 ml vials. ",5/28/2013,"05/28/2013",12/11/2013,"12/11/2013"
"Drugs",65479,"Ongoing","Main Street Family Pharmacy, LLC","Newbern","TN","US","Voluntary: Firm Initiated","Telephone","nationwide, specifically: AK, AL, AZ, CA, CO, CT, DC, FL, GA, HI, IL, IN, KS, KY, LA, MA, MD, MN, MO, MS, NC, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, SC, TN, TX, UT, VA, WA, WI, and WV","D-081-2014","Class II","Double Strength PGE1 40mcg/ml, Main Street Compounding Pharmacy, 126 East Main Street, Newbern, TN 38059, 888-658-6200","all codes distributed prior to and including 05/23/2013",".","3 units","The firm received seven reports of adverse reactions in the form of skin abscesses potentially linked to compounded preservative-free methylprednisolone 80mg/ml 10 ml vials. ",5/28/2013,"05/28/2013",12/11/2013,"12/11/2013"
"Drugs",65479,"Ongoing","Main Street Family Pharmacy, LLC","Newbern","TN","US","Voluntary: Firm Initiated","Telephone","nationwide, specifically: AK, AL, AZ, CA, CO, CT, DC, FL, GA, HI, IL, IN, KS, KY, LA, MA, MD, MN, MO, MS, NC, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, SC, TN, TX, UT, VA, WA, WI, and WV","D-136-2014","Class II","HCG 340 iu prefilled syringes, Main Street Compounding Pharmacy, 126 East Main Street, Newbern, TN 38059, 888-658-6200","all codes distributed prior to and including 05/23/2013",".","5315 units","The firm received seven reports of adverse reactions in the form of skin abscesses potentially linked to compounded preservative-free methylprednisolone 80mg/ml 10 ml vials. ",5/28/2013,"05/28/2013",12/11/2013,"12/11/2013"
"Drugs",65479,"Ongoing","Main Street Family Pharmacy, LLC","Newbern","TN","US","Voluntary: Firm Initiated","Telephone","nationwide, specifically: AK, AL, AZ, CA, CO, CT, DC, FL, GA, HI, IL, IN, KS, KY, LA, MA, MD, MN, MO, MS, NC, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, SC, TN, TX, UT, VA, WA, WI, and WV","D-146-2014","Class II","HCG 5000iu, Main Street Compounding Pharmacy, 126 East Main Street, Newbern, TN 38059, 888-658-6200","all codes distributed prior to and including 05/23/2013",".","137 units","The firm received seven reports of adverse reactions in the form of skin abscesses potentially linked to compounded preservative-free methylprednisolone 80mg/ml 10 ml vials. ",5/28/2013,"05/28/2013",12/11/2013,"12/11/2013"
"Drugs",65479,"Ongoing","Main Street Family Pharmacy, LLC","Newbern","TN","US","Voluntary: Firm Initiated","Telephone","nationwide, specifically: AK, AL, AZ, CA, CO, CT, DC, FL, GA, HI, IL, IN, KS, KY, LA, MA, MD, MN, MO, MS, NC, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, SC, TN, TX, UT, VA, WA, WI, and WV","D-293-2014","Class II","Testosterone Cypionate 210mg 10ml, Main Street Compounding Pharmacy, 126 East Main Street, Newbern, TN 38059, 888-658-6200","distributed prior to and including 05/23/2013",".","60 units","The firm received seven reports of adverse reactions in the form of skin abscesses potentially linked to compounded preservative-free methylprednisolone 80mg/ml 10 ml vials. ",5/28/2013,"05/28/2013",12/11/2013,"12/11/2013"
"Drugs",65479,"Ongoing","Main Street Family Pharmacy, LLC","Newbern","TN","US","Voluntary: Firm Initiated","Telephone","nationwide, specifically: AK, AL, AZ, CA, CO, CT, DC, FL, GA, HI, IL, IN, KS, KY, LA, MA, MD, MN, MO, MS, NC, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, SC, TN, TX, UT, VA, WA, WI, and WV","D-054-2014","Class II","Betamethasone NA Phosphate (PF) 6mg/ml 10ml, Main Street Compounding Pharmacy, 126 East Main Street, Newbern, TN 38059, 888-658-6200","all codes distributed prior to and including 05/23/2013",".","2 units","The firm received seven reports of adverse reactions in the form of skin abscesses potentially linked to compounded preservative-free methylprednisolone 80mg/ml 10 ml vials. ",5/28/2013,"05/28/2013",12/11/2013,"12/11/2013"
"Drugs",65479,"Ongoing","Main Street Family Pharmacy, LLC","Newbern","TN","US","Voluntary: Firm Initiated","Telephone","nationwide, specifically: AK, AL, AZ, CA, CO, CT, DC, FL, GA, HI, IL, IN, KS, KY, LA, MA, MD, MN, MO, MS, NC, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, SC, TN, TX, UT, VA, WA, WI, and WV","D-173-2014","Class II","Lipo X 50ml, Main Street Compounding Pharmacy, 126 East Main Street, Newbern, TN 38059, 888-658-6200","all codes distributed prior to and including 05/23/2013",".","85 units","The firm received seven reports of adverse reactions in the form of skin abscesses potentially linked to compounded preservative-free methylprednisolone 80mg/ml 10 ml vials. ",5/28/2013,"05/28/2013",12/11/2013,"12/11/2013"
"Drugs",65479,"Ongoing","Main Street Family Pharmacy, LLC","Newbern","TN","US","Voluntary: Firm Initiated","Telephone","nationwide, specifically: AK, AL, AZ, CA, CO, CT, DC, FL, GA, HI, IL, IN, KS, KY, LA, MA, MD, MN, MO, MS, NC, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, SC, TN, TX, UT, VA, WA, WI, and WV","D-267-2014","Class II","Single Strength PGE1 20mcg/ml, Main Street Compounding Pharmacy, 126 East Main Street, Newbern, TN 38059, 888-658-6200","all codes distributed prior to and including 05/23/2013",".","3 units","The firm received seven reports of adverse reactions in the form of skin abscesses potentially linked to compounded preservative-free methylprednisolone 80mg/ml 10 ml vials. ",5/28/2013,"05/28/2013",12/11/2013,"12/11/2013"
"Drugs",65479,"Ongoing","Main Street Family Pharmacy, LLC","Newbern","TN","US","Voluntary: Firm Initiated","Telephone","nationwide, specifically: AK, AL, AZ, CA, CO, CT, DC, FL, GA, HI, IL, IN, KS, KY, LA, MA, MD, MN, MO, MS, NC, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, SC, TN, TX, UT, VA, WA, WI, and WV","D-164-2014","Class II","Lidocaine 4%/Phenylephrine 1% 5, Main Street Compounding Pharmacy, 126 East Main Street, Newbern, TN 38059, 888-658-6200","all codes distributed prior to and including 05/23/2013",".","30 units","The firm received seven reports of adverse reactions in the form of skin abscesses potentially linked to compounded preservative-free methylprednisolone 80mg/ml 10 ml vials. ",5/28/2013,"05/28/2013",12/11/2013,"12/11/2013"
"Drugs",65479,"Ongoing","Main Street Family Pharmacy, LLC","Newbern","TN","US","Voluntary: Firm Initiated","Telephone","nationwide, specifically: AK, AL, AZ, CA, CO, CT, DC, FL, GA, HI, IL, IN, KS, KY, LA, MA, MD, MN, MO, MS, NC, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, SC, TN, TX, UT, VA, WA, WI, and WV","D-274-2014","Class II","Special Mic Formula 30ml, Main Street Compounding Pharmacy, 126 East Main Street, Newbern, TN 38059, 888-658-6200","all codes distributed prior to and including 05/23/2013",".","10 units","The firm received seven reports of adverse reactions in the form of skin abscesses potentially linked to compounded preservative-free methylprednisolone 80mg/ml 10 ml vials. ",5/28/2013,"05/28/2013",12/11/2013,"12/11/2013"
"Drugs",65479,"Ongoing","Main Street Family Pharmacy, LLC","Newbern","TN","US","Voluntary: Firm Initiated","Telephone","nationwide, specifically: AK, AL, AZ, CA, CO, CT, DC, FL, GA, HI, IL, IN, KS, KY, LA, MA, MD, MN, MO, MS, NC, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, SC, TN, TX, UT, VA, WA, WI, and WV","D-170-2014","Class II","Lipo Blast 50ml, Methionine 25mg, Inositol 50 mg, Choline 100mg, Methyl B-12.25mg, B6 25mg, B5 12.5 mg, Lidocaine 10mg, B7 5mg, adenosine 12.5mg, B1 12.5mg, B2 2.5mg, B3 12.5mg, Benzyl Alcohol .02ml 50mlMain Street Compounding Pharmacy, 126 East Main Street, Newbern, TN 38059, 888-658-6200","all codes distributed prior to and including 05/23/2013",".","66 units","The firm received seven reports of adverse reactions in the form of skin abscesses potentially linked to compounded preservative-free methylprednisolone 80mg/ml 10 ml vials. ",5/28/2013,"05/28/2013",12/11/2013,"12/11/2013"
"Drugs",65479,"Ongoing","Main Street Family Pharmacy, LLC","Newbern","TN","US","Voluntary: Firm Initiated","Telephone","nationwide, specifically: AK, AL, AZ, CA, CO, CT, DC, FL, GA, HI, IL, IN, KS, KY, LA, MA, MD, MN, MO, MS, NC, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, SC, TN, TX, UT, VA, WA, WI, and WV","D-038-2014","Class II","Amikacin 500mg 2ml, Main Street Compounding Pharmacy, 126 East Main Street, Newbern, TN 38059, 888-658-6200","all codes distributed prior to and including 05/23/2013",".","744 units","The firm received seven reports of adverse reactions in the form of skin abscesses potentially linked to compounded preservative-free methylprednisolone 80mg/ml 10 ml vials. ",5/28/2013,"05/28/2013",12/11/2013,"12/11/2013"
"Drugs",65479,"Ongoing","Main Street Family Pharmacy, LLC","Newbern","TN","US","Voluntary: Firm Initiated","Telephone","nationwide, specifically: AK, AL, AZ, CA, CO, CT, DC, FL, GA, HI, IL, IN, KS, KY, LA, MA, MD, MN, MO, MS, NC, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, SC, TN, TX, UT, VA, WA, WI, and WV","D-108-2014","Class II","HCG 12000u, Main Street Compounding Pharmacy, 126 East Main Street, Newbern, TN 38059, 888-658-6200","all codes distributed prior to and including 05/23/2013",".","16 units","The firm received seven reports of adverse reactions in the form of skin abscesses potentially linked to compounded preservative-free methylprednisolone 80mg/ml 10 ml vials. ",5/28/2013,"05/28/2013",12/11/2013,"12/11/2013"
"Drugs",65479,"Ongoing","Main Street Family Pharmacy, LLC","Newbern","TN","US","Voluntary: Firm Initiated","Telephone","nationwide, specifically: AK, AL, AZ, CA, CO, CT, DC, FL, GA, HI, IL, IN, KS, KY, LA, MA, MD, MN, MO, MS, NC, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, SC, TN, TX, UT, VA, WA, WI, and WV","D-287-2014","Class II","Testosterone 210mg 10ml (compounded), Main Street Compounding Pharmacy, 126 East Main Street, Newbern, TN 38059, 888-658-6200","distributed prior to and including 05/23/2013",".","151 units","The firm received seven reports of adverse reactions in the form of skin abscesses potentially linked to compounded preservative-free methylprednisolone 80mg/ml 10 ml vials. ",5/28/2013,"05/28/2013",12/11/2013,"12/11/2013"
"Drugs",65479,"Ongoing","Main Street Family Pharmacy, LLC","Newbern","TN","US","Voluntary: Firm Initiated","Telephone","nationwide, specifically: AK, AL, AZ, CA, CO, CT, DC, FL, GA, HI, IL, IN, KS, KY, LA, MA, MD, MN, MO, MS, NC, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, SC, TN, TX, UT, VA, WA, WI, and WV","D-065-2014","Class II","Calcium Gluconate 10% 50ml, Main Street Compounding Pharmacy, 126 East Main Street, Newbern, TN 38059, 888-658-6200","all codes distributed prior to and including 05/23/2013",".","25 units","The firm received seven reports of adverse reactions in the form of skin abscesses potentially linked to compounded preservative-free methylprednisolone 80mg/ml 10 ml vials. ",5/28/2013,"05/28/2013",12/11/2013,"12/11/2013"
"Drugs",65479,"Ongoing","Main Street Family Pharmacy, LLC","Newbern","TN","US","Voluntary: Firm Initiated","Telephone","nationwide, specifically: AK, AL, AZ, CA, CO, CT, DC, FL, GA, HI, IL, IN, KS, KY, LA, MA, MD, MN, MO, MS, NC, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, SC, TN, TX, UT, VA, WA, WI, and WV","D-284-2014","Class II","Testosterone Cypionate/Testosterone Propionate 250mg 10ml, Main Street Compounding Pharmacy, 126 East Main Street, Newbern, TN 38059, 888-658-6200","all codes distributed prior to and including 05/23/2013",".","14 units","The firm received seven reports of adverse reactions in the form of skin abscesses potentially linked to compounded preservative-free methylprednisolone 80mg/ml 10 ml vials. ",5/28/2013,"05/28/2013",12/11/2013,"12/11/2013"
"Drugs",65479,"Ongoing","Main Street Family Pharmacy, LLC","Newbern","TN","US","Voluntary: Firm Initiated","Telephone","nationwide, specifically: AK, AL, AZ, CA, CO, CT, DC, FL, GA, HI, IL, IN, KS, KY, LA, MA, MD, MN, MO, MS, NC, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, SC, TN, TX, UT, VA, WA, WI, and WV","D-196-2014","Class II","Marcaine .2% NS 300ml, Main Street Compounding Pharmacy, 126 East Main Street, Newbern, TN 38059, 888-658-6200","all codes distributed prior to and including 05/23/2013",".","233 units","The firm received seven reports of adverse reactions in the form of skin abscesses potentially linked to compounded preservative-free methylprednisolone 80mg/ml 10 ml vials. ",5/28/2013,"05/28/2013",12/11/2013,"12/11/2013"
"Drugs",65479,"Ongoing","Main Street Family Pharmacy, LLC","Newbern","TN","US","Voluntary: Firm Initiated","Telephone","nationwide, specifically: AK, AL, AZ, CA, CO, CT, DC, FL, GA, HI, IL, IN, KS, KY, LA, MA, MD, MN, MO, MS, NC, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, SC, TN, TX, UT, VA, WA, WI, and WV","D-171-2014","Class II","Lipo Blast w/o adenosine,Methionine 25mg, Inositol 50 mg, Choline 100mg, Methyl B-12 .25mg, B6 25mg, B5 12.5 mg, Lidocaine 10mg, B7 5mg, B1 12.5mg, B2 2.5mg, B3 12.5mg, Benzyl Alcohol .02ml 50ml, Main Street Compounding Pharmacy, 126 East Main Street, Newbern, TN 38059, 888-658-6200","all codes distributed prior to and including 05/23/2013",".","6 units","The firm received seven reports of adverse reactions in the form of skin abscesses potentially linked to compounded preservative-free methylprednisolone 80mg/ml 10 ml vials. ",5/28/2013,"05/28/2013",12/11/2013,"12/11/2013"
"Drugs",65479,"Ongoing","Main Street Family Pharmacy, LLC","Newbern","TN","US","Voluntary: Firm Initiated","Telephone","nationwide, specifically: AK, AL, AZ, CA, CO, CT, DC, FL, GA, HI, IL, IN, KS, KY, LA, MA, MD, MN, MO, MS, NC, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, SC, TN, TX, UT, VA, WA, WI, and WV","D-165-2014","Class II","Lincomycin 300 (PF) 10ml, Main Street Compounding Pharmacy, 126 East Main Street, Newbern, TN 38059, 888-658-6200","all codes distributed prior to and including 05/23/2013",".","1516 units","The firm received seven reports of adverse reactions in the form of skin abscesses potentially linked to compounded preservative-free methylprednisolone 80mg/ml 10 ml vials. ",5/28/2013,"05/28/2013",12/11/2013,"12/11/2013"
"Drugs",65479,"Ongoing","Main Street Family Pharmacy, LLC","Newbern","TN","US","Voluntary: Firm Initiated","Telephone","nationwide, specifically: AK, AL, AZ, CA, CO, CT, DC, FL, GA, HI, IL, IN, KS, KY, LA, MA, MD, MN, MO, MS, NC, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, SC, TN, TX, UT, VA, WA, WI, and WV","D-184-2014","Class II","Lipotropic 1ml PFS, Main Street Compounding Pharmacy, 126 East Main Street, Newbern, TN 38059, 888-658-6200","all codes distributed prior to and including 05/23/2013",".","147 units ","The firm received seven reports of adverse reactions in the form of skin abscesses potentially linked to compounded preservative-free methylprednisolone 80mg/ml 10 ml vials. ",5/28/2013,"05/28/2013",12/11/2013,"12/11/2013"
"Drugs",65479,"Ongoing","Main Street Family Pharmacy, LLC","Newbern","TN","US","Voluntary: Firm Initiated","Telephone","nationwide, specifically: AK, AL, AZ, CA, CO, CT, DC, FL, GA, HI, IL, IN, KS, KY, LA, MA, MD, MN, MO, MS, NC, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, SC, TN, TX, UT, VA, WA, WI, and WV","D-294-2014","Class II","Testosterone Cypionate 300mg/ml, 10ml Main Street Compounding Pharmacy, 126 East Main Street, Newbern, TN 38059, 888-658-6200","distributed prior to and including 05/23/2013",".","1 vial","The firm received seven reports of adverse reactions in the form of skin abscesses potentially linked to compounded preservative-free methylprednisolone 80mg/ml 10 ml vials. ",5/28/2013,"05/28/2013",12/11/2013,"12/11/2013"
"Drugs",65479,"Ongoing","Main Street Family Pharmacy, LLC","Newbern","TN","US","Voluntary: Firm Initiated","Telephone","nationwide, specifically: AK, AL, AZ, CA, CO, CT, DC, FL, GA, HI, IL, IN, KS, KY, LA, MA, MD, MN, MO, MS, NC, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, SC, TN, TX, UT, VA, WA, WI, and WV","D-077-2014","Class II","Dexamethasone LA 8mg/ml 10ml, Main Street Compounding Pharmacy, 126 East Main Street, Newbern, TN 38059, 888-658-6200","all codes distributed prior to and including 05/23/2013",".","492 units","The firm received seven reports of adverse reactions in the form of skin abscesses potentially linked to compounded preservative-free methylprednisolone 80mg/ml 10 ml vials. ",5/28/2013,"05/28/2013",12/11/2013,"12/11/2013"
"Drugs",65479,"Ongoing","Main Street Family Pharmacy, LLC","Newbern","TN","US","Voluntary: Firm Initiated","Telephone","nationwide, specifically: AK, AL, AZ, CA, CO, CT, DC, FL, GA, HI, IL, IN, KS, KY, LA, MA, MD, MN, MO, MS, NC, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, SC, TN, TX, UT, VA, WA, WI, and WV","D-200-2014","Class II","Medroxyprogesterone 150mg 10ml, Main Street Compounding Pharmacy, 126 East Main Street, Newbern, TN 38059, 888-658-6200","all codes distributed prior to and including 05/23/2013",".","5 units","The firm received seven reports of adverse reactions in the form of skin abscesses potentially linked to compounded preservative-free methylprednisolone 80mg/ml 10 ml vials. ",5/28/2013,"05/28/2013",12/11/2013,"12/11/2013"
"Drugs",65479,"Ongoing","Main Street Family Pharmacy, LLC","Newbern","TN","US","Voluntary: Firm Initiated","Telephone","nationwide, specifically: AK, AL, AZ, CA, CO, CT, DC, FL, GA, HI, IL, IN, KS, KY, LA, MA, MD, MN, MO, MS, NC, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, SC, TN, TX, UT, VA, WA, WI, and WV","D-037-2014","Class II","Amikacin 250mg/ml 2ml vial, Main Street Compounding Pharmacy, 126 East Main Street, Newbern, TN 38059, 888-658-6200","all codes distributed prior to and including 05/23/2013",".","113 units","The firm received seven reports of adverse reactions in the form of skin abscesses potentially linked to compounded preservative-free methylprednisolone 80mg/ml 10 ml vials. ",5/28/2013,"05/28/2013",12/11/2013,"12/11/2013"
"Drugs",65479,"Ongoing","Main Street Family Pharmacy, LLC","Newbern","TN","US","Voluntary: Firm Initiated","Telephone","nationwide, specifically: AK, AL, AZ, CA, CO, CT, DC, FL, GA, HI, IL, IN, KS, KY, LA, MA, MD, MN, MO, MS, NC, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, SC, TN, TX, UT, VA, WA, WI, and WV","D-154-2014","Class II","L-Arginine 100mg/ml 30ml, Main Street Compounding Pharmacy, 126 East Main Street, Newbern, TN 38059, 888-658-6200","all codes distributed prior to and including 05/23/2013",".","23 units","The firm received seven reports of adverse reactions in the form of skin abscesses potentially linked to compounded preservative-free methylprednisolone 80mg/ml 10 ml vials. ",5/28/2013,"05/28/2013",12/11/2013,"12/11/2013"
"Drugs",65479,"Ongoing","Main Street Family Pharmacy, LLC","Newbern","TN","US","Voluntary: Firm Initiated","Telephone","nationwide, specifically: AK, AL, AZ, CA, CO, CT, DC, FL, GA, HI, IL, IN, KS, KY, LA, MA, MD, MN, MO, MS, NC, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, SC, TN, TX, UT, VA, WA, WI, and WV","D-292-2014","Class II","Testosterone Cypionate 200mg/ml, 10ml Main Street Compounding Pharmacy, 126 East Main Street, Newbern, TN 38059, 888-658-6200","distributed prior to and including 05/23/2013",".","16 units","The firm received seven reports of adverse reactions in the form of skin abscesses potentially linked to compounded preservative-free methylprednisolone 80mg/ml 10 ml vials. ",5/28/2013,"05/28/2013",12/11/2013,"12/11/2013"
"Drugs",65479,"Ongoing","Main Street Family Pharmacy, LLC","Newbern","TN","US","Voluntary: Firm Initiated","Telephone","nationwide, specifically: AK, AL, AZ, CA, CO, CT, DC, FL, GA, HI, IL, IN, KS, KY, LA, MA, MD, MN, MO, MS, NC, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, SC, TN, TX, UT, VA, WA, WI, and WV","D-321-2014","Class II","Wydase 1ml, Main Street Compounding Pharmacy, 126 East Main Street, Newbern, TN 38059, 888-658-6200","all codes distributed prior to and including 05/23/2013",".","450 units","The firm received seven reports of adverse reactions in the form of skin abscesses potentially linked to compounded preservative-free methylprednisolone 80mg/ml 10 ml vials. ",5/28/2013,"05/28/2013",12/11/2013,"12/11/2013"
"Drugs",65479,"Ongoing","Main Street Family Pharmacy, LLC","Newbern","TN","US","Voluntary: Firm Initiated","Telephone","nationwide, specifically: AK, AL, AZ, CA, CO, CT, DC, FL, GA, HI, IL, IN, KS, KY, LA, MA, MD, MN, MO, MS, NC, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, SC, TN, TX, UT, VA, WA, WI, and WV","D-078-2014","Class II","Dexamethasone LA 16mg 30ml, Main Street Compounding Pharmacy, 126 East Main Street, Newbern, TN 38059, 888-658-6200","all codes distributed prior to and including 05/23/2013",".","6 units","The firm received seven reports of adverse reactions in the form of skin abscesses potentially linked to compounded preservative-free methylprednisolone 80mg/ml 10 ml vials. ",5/28/2013,"05/28/2013",12/11/2013,"12/11/2013"
"Drugs",65479,"Ongoing","Main Street Family Pharmacy, LLC","Newbern","TN","US","Voluntary: Firm Initiated","Telephone","nationwide, specifically: AK, AL, AZ, CA, CO, CT, DC, FL, GA, HI, IL, IN, KS, KY, LA, MA, MD, MN, MO, MS, NC, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, SC, TN, TX, UT, VA, WA, WI, and WV","D-188-2014","Class II","Lipotropic 50ml w/L-Carnitine, Main Street Compounding Pharmacy, 126 East Main Street, Newbern, TN 38059, 888-658-6200","all codes distributed prior to and including 05/23/2013",".","75 units","The firm received seven reports of adverse reactions in the form of skin abscesses potentially linked to compounded preservative-free methylprednisolone 80mg/ml 10 ml vials. ",5/28/2013,"05/28/2013",12/11/2013,"12/11/2013"
"Drugs",65479,"Ongoing","Main Street Family Pharmacy, LLC","Newbern","TN","US","Voluntary: Firm Initiated","Telephone","nationwide, specifically: AK, AL, AZ, CA, CO, CT, DC, FL, GA, HI, IL, IN, KS, KY, LA, MA, MD, MN, MO, MS, NC, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, SC, TN, TX, UT, VA, WA, WI, and WV","D-095-2014","Class II","Estradiol Pellets 6mg, Main Street Compounding Pharmacy, 126 East Main Street, Newbern, TN 38059, 888-658-6200","all codes distributed prior to and including 05/23/2013",".","543 units","The firm received seven reports of adverse reactions in the form of skin abscesses potentially linked to compounded preservative-free methylprednisolone 80mg/ml 10 ml vials. ",5/28/2013,"05/28/2013",12/11/2013,"12/11/2013"
"Drugs",65479,"Ongoing","Main Street Family Pharmacy, LLC","Newbern","TN","US","Voluntary: Firm Initiated","Telephone","nationwide, specifically: AK, AL, AZ, CA, CO, CT, DC, FL, GA, HI, IL, IN, KS, KY, LA, MA, MD, MN, MO, MS, NC, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, SC, TN, TX, UT, VA, WA, WI, and WV","D-051-2014","Class II","B-Complex 206 mg/ml 30ml, Main Street Compounding Pharmacy, 126 East Main Street, Newbern, TN 38059, 888-658-6200","all codes distributed prior to and including 05/23/2013",".","1 unit","The firm received seven reports of adverse reactions in the form of skin abscesses potentially linked to compounded preservative-free methylprednisolone 80mg/ml 10 ml vials. ",5/28/2013,"05/28/2013",12/11/2013,"12/11/2013"
"Drugs",65479,"Ongoing","Main Street Family Pharmacy, LLC","Newbern","TN","US","Voluntary: Firm Initiated","Telephone","nationwide, specifically: AK, AL, AZ, CA, CO, CT, DC, FL, GA, HI, IL, IN, KS, KY, LA, MA, MD, MN, MO, MS, NC, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, SC, TN, TX, UT, VA, WA, WI, and WV","D-249-2014","Class II","Mitomycin 40mg Compounded, Main Street Compounding Pharmacy, 126 East Main Street, Newbern, TN 38059, 888-658-6200","all codes distributed prior to and including 05/23/2013",".","10 units","The firm received seven reports of adverse reactions in the form of skin abscesses potentially linked to compounded preservative-free methylprednisolone 80mg/ml 10 ml vials. ",5/28/2013,"05/28/2013",12/11/2013,"12/11/2013"
"Drugs",65479,"Ongoing","Main Street Family Pharmacy, LLC","Newbern","TN","US","Voluntary: Firm Initiated","Telephone","nationwide, specifically: AK, AL, AZ, CA, CO, CT, DC, FL, GA, HI, IL, IN, KS, KY, LA, MA, MD, MN, MO, MS, NC, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, SC, TN, TX, UT, VA, WA, WI, and WV","D-241-2014","Class II","Mic Ultra-Sulfur Free 30ml, Main Street Compounding Pharmacy, 126 East Main Street, Newbern, TN 38059, 888-658-6200","all codes distributed prior to and including 05/23/2013",".","115 units","The firm received seven reports of adverse reactions in the form of skin abscesses potentially linked to compounded preservative-free methylprednisolone 80mg/ml 10 ml vials. ",5/28/2013,"05/28/2013",12/11/2013,"12/11/2013"
"Drugs",65479,"Ongoing","Main Street Family Pharmacy, LLC","Newbern","TN","US","Voluntary: Firm Initiated","Telephone","nationwide, specifically: AK, AL, AZ, CA, CO, CT, DC, FL, GA, HI, IL, IN, KS, KY, LA, MA, MD, MN, MO, MS, NC, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, SC, TN, TX, UT, VA, WA, WI, and WV","D-036-2014","Class II","Amikacin 250mg/ml 2ml, Main Street Compounding Pharmacy, 126 East Main Street, Newbern, TN 38059, 888-658-6200","all codes distributed prior to and including 05/23/2013",".","50 units","The firm received seven reports of adverse reactions in the form of skin abscesses potentially linked to compounded preservative-free methylprednisolone 80mg/ml 10 ml vials. ",5/28/2013,"05/28/2013",12/11/2013,"12/11/2013"
"Drugs",65479,"Ongoing","Main Street Family Pharmacy, LLC","Newbern","TN","US","Voluntary: Firm Initiated","Telephone","nationwide, specifically: AK, AL, AZ, CA, CO, CT, DC, FL, GA, HI, IL, IN, KS, KY, LA, MA, MD, MN, MO, MS, NC, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, SC, TN, TX, UT, VA, WA, WI, and WV","D-139-2014","Class II","HCG 370iu prefilled syringes, Main Street Compounding Pharmacy, 126 East Main Street, Newbern, TN 38059, 888-658-6200","all codes distributed prior to and including 05/23/2013",".","426 units","The firm received seven reports of adverse reactions in the form of skin abscesses potentially linked to compounded preservative-free methylprednisolone 80mg/ml 10 ml vials. ",5/28/2013,"05/28/2013",12/11/2013,"12/11/2013"
"Drugs",65479,"Ongoing","Main Street Family Pharmacy, LLC","Newbern","TN","US","Voluntary: Firm Initiated","Telephone","nationwide, specifically: AK, AL, AZ, CA, CO, CT, DC, FL, GA, HI, IL, IN, KS, KY, LA, MA, MD, MN, MO, MS, NC, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, SC, TN, TX, UT, VA, WA, WI, and WV","D-174-2014","Class II","Lipoden 50ml, Main Street Compounding Pharmacy, 126 East Main Street, Newbern, TN 38059, 888-658-6200","all codes distributed prior to and including 05/23/2013",".","100 units","The firm received seven reports of adverse reactions in the form of skin abscesses potentially linked to compounded preservative-free methylprednisolone 80mg/ml 10 ml vials. ",5/28/2013,"05/28/2013",12/11/2013,"12/11/2013"
"Drugs",65479,"Ongoing","Main Street Family Pharmacy, LLC","Newbern","TN","US","Voluntary: Firm Initiated","Telephone","nationwide, specifically: AK, AL, AZ, CA, CO, CT, DC, FL, GA, HI, IL, IN, KS, KY, LA, MA, MD, MN, MO, MS, NC, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, SC, TN, TX, UT, VA, WA, WI, and WV","D-073-2014","Class II","Dexamethasone 4/8, Main Street Compounding Pharmacy, 126 East Main Street, Newbern, TN 38059, 888-658-6200","all codes distributed prior to and including 05/23/2013",".","311 units","The firm received seven reports of adverse reactions in the form of skin abscesses potentially linked to compounded preservative-free methylprednisolone 80mg/ml 10 ml vials. ",5/28/2013,"05/28/2013",12/11/2013,"12/11/2013"
"Drugs",65479,"Ongoing","Main Street Family Pharmacy, LLC","Newbern","TN","US","Voluntary: Firm Initiated","Telephone","nationwide, specifically: AK, AL, AZ, CA, CO, CT, DC, FL, GA, HI, IL, IN, KS, KY, LA, MA, MD, MN, MO, MS, NC, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, SC, TN, TX, UT, VA, WA, WI, and WV","D-103-2014","Class II","HCG 100 iu prefilled syringes, Main Street Compounding Pharmacy, 126 East Main Street, Newbern, TN 38059, 888-658-6200","all codes distributed prior to and including 05/23/2013",".","3 units","The firm received seven reports of adverse reactions in the form of skin abscesses potentially linked to compounded preservative-free methylprednisolone 80mg/ml 10 ml vials. ",5/28/2013,"05/28/2013",12/11/2013,"12/11/2013"
"Drugs",65479,"Ongoing","Main Street Family Pharmacy, LLC","Newbern","TN","US","Voluntary: Firm Initiated","Telephone","nationwide, specifically: AK, AL, AZ, CA, CO, CT, DC, FL, GA, HI, IL, IN, KS, KY, LA, MA, MD, MN, MO, MS, NC, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, SC, TN, TX, UT, VA, WA, WI, and WV","D-286-2014","Class II","Testosterone 200mg 30ml (compounded), Main Street Compounding Pharmacy, 126 East Main Street, Newbern, TN 38059, 888-658-6200","distributed prior to and including 05/23/2013",".","4 units","The firm received seven reports of adverse reactions in the form of skin abscesses potentially linked to compounded preservative-free methylprednisolone 80mg/ml 10 ml vials. ",5/28/2013,"05/28/2013",12/11/2013,"12/11/2013"
"Drugs",65479,"Ongoing","Main Street Family Pharmacy, LLC","Newbern","TN","US","Voluntary: Firm Initiated","Telephone","nationwide, specifically: AK, AL, AZ, CA, CO, CT, DC, FL, GA, HI, IL, IN, KS, KY, LA, MA, MD, MN, MO, MS, NC, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, SC, TN, TX, UT, VA, WA, WI, and WV","D-270-2014","Class II","Sodium Tetradecyl Sulfate 2.0% 30ml, Main Street Compounding Pharmacy, 126 East Main Street, Newbern, TN 38059, 888-658-6200","all codes distributed prior to and including 05/23/2013",".","1 unit","The firm received seven reports of adverse reactions in the form of skin abscesses potentially linked to compounded preservative-free methylprednisolone 80mg/ml 10 ml vials. ",5/28/2013,"05/28/2013",12/11/2013,"12/11/2013"
"Drugs",65479,"Ongoing","Main Street Family Pharmacy, LLC","Newbern","TN","US","Voluntary: Firm Initiated","Telephone","nationwide, specifically: AK, AL, AZ, CA, CO, CT, DC, FL, GA, HI, IL, IN, KS, KY, LA, MA, MD, MN, MO, MS, NC, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, SC, TN, TX, UT, VA, WA, WI, and WV","D-087-2014","Class II","Estradiol Pellet 37.5mg, Main Street Compounding Pharmacy, 126 East Main Street, Newbern, TN 38059, 888-658-6200","all codes distributed prior to and including 05/23/2013",".","5 units","The firm received seven reports of adverse reactions in the form of skin abscesses potentially linked to compounded preservative-free methylprednisolone 80mg/ml 10 ml vials. ",5/28/2013,"05/28/2013",12/11/2013,"12/11/2013"
"Drugs",65479,"Ongoing","Main Street Family Pharmacy, LLC","Newbern","TN","US","Voluntary: Firm Initiated","Telephone","nationwide, specifically: AK, AL, AZ, CA, CO, CT, DC, FL, GA, HI, IL, IN, KS, KY, LA, MA, MD, MN, MO, MS, NC, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, SC, TN, TX, UT, VA, WA, WI, and WV","D-055-2014","Class II","Betamethasone 6mg 10ml, Main Street Compounding Pharmacy, 126 East Main Street, Newbern, TN 38059, 888-658-6200","all codes distributed prior to and including 05/23/2013",".","6085 units","The firm received seven reports of adverse reactions in the form of skin abscesses potentially linked to compounded preservative-free methylprednisolone 80mg/ml 10 ml vials. ",5/28/2013,"05/28/2013",12/11/2013,"12/11/2013"
"Drugs",65479,"Ongoing","Main Street Family Pharmacy, LLC","Newbern","TN","US","Voluntary: Firm Initiated","Telephone","nationwide, specifically: AK, AL, AZ, CA, CO, CT, DC, FL, GA, HI, IL, IN, KS, KY, LA, MA, MD, MN, MO, MS, NC, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, SC, TN, TX, UT, VA, WA, WI, and WV","D-035-2014","Class II","AMIC-12 w/out lido10ml , Main Street Compounding Pharmacy, 126 East Main Street, Newbern, TN 38059, 888-658-6200","all codes distributed prior to and including 05/23/2013",".","1722 units","The firm received seven reports of adverse reactions in the form of skin abscesses potentially linked to compounded preservative-free methylprednisolone 80mg/ml 10 ml vials. ",5/28/2013,"05/28/2013",12/11/2013,"12/11/2013"
"Drugs",65479,"Ongoing","Main Street Family Pharmacy, LLC","Newbern","TN","US","Voluntary: Firm Initiated","Telephone","nationwide, specifically: AK, AL, AZ, CA, CO, CT, DC, FL, GA, HI, IL, IN, KS, KY, LA, MA, MD, MN, MO, MS, NC, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, SC, TN, TX, UT, VA, WA, WI, and WV","D-168-2014","Class II","Lipo B (Mic w/B5/B6/B12+Lido), Main Street Compounding Pharmacy, 126 East Main Street, Newbern, TN 38059, 888-658-6200","all codes distributed prior to and including 05/23/2013",".","80 units","The firm received seven reports of adverse reactions in the form of skin abscesses potentially linked to compounded preservative-free methylprednisolone 80mg/ml 10 ml vials. ",5/28/2013,"05/28/2013",12/11/2013,"12/11/2013"
"Drugs",65479,"Ongoing","Main Street Family Pharmacy, LLC","Newbern","TN","US","Voluntary: Firm Initiated","Telephone","nationwide, specifically: AK, AL, AZ, CA, CO, CT, DC, FL, GA, HI, IL, IN, KS, KY, LA, MA, MD, MN, MO, MS, NC, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, SC, TN, TX, UT, VA, WA, WI, and WV","D-100-2014","Class II","Glycerin 72%, Lido1%, w/Epi 2;1, Main Street Compounding Pharmacy, 126 East Main Street, Newbern, TN 38059, 888-658-6200","all codes distributed prior to and including 05/23/2013",".","1 unit","The firm received seven reports of adverse reactions in the form of skin abscesses potentially linked to compounded preservative-free methylprednisolone 80mg/ml 10 ml vials. ",5/28/2013,"05/28/2013",12/11/2013,"12/11/2013"
"Drugs",65479,"Ongoing","Main Street Family Pharmacy, LLC","Newbern","TN","US","Voluntary: Firm Initiated","Telephone","nationwide, specifically: AK, AL, AZ, CA, CO, CT, DC, FL, GA, HI, IL, IN, KS, KY, LA, MA, MD, MN, MO, MS, NC, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, SC, TN, TX, UT, VA, WA, WI, and WV","D-070-2014","Class II","Depo-Testadiiol, Main Street Compounding Pharmacy, 126 East Main Street, Newbern, TN 38059, 888-658-6200","all codes distributed prior to and including 05/23/2013",".","2 units","The firm received seven reports of adverse reactions in the form of skin abscesses potentially linked to compounded preservative-free methylprednisolone 80mg/ml 10 ml vials. ",5/28/2013,"05/28/2013",12/11/2013,"12/11/2013"
"Drugs",65479,"Ongoing","Main Street Family Pharmacy, LLC","Newbern","TN","US","Voluntary: Firm Initiated","Telephone","nationwide, specifically: AK, AL, AZ, CA, CO, CT, DC, FL, GA, HI, IL, IN, KS, KY, LA, MA, MD, MN, MO, MS, NC, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, SC, TN, TX, UT, VA, WA, WI, and WV","D-260-2014","Class II","Pre-menopausal HCG PK 2nd month, Main Street Compounding Pharmacy, 126 East Main Street, Newbern, TN 38059, 888-658-6200","all codes distributed prior to and including 05/23/2013",".","58 units","The firm received seven reports of adverse reactions in the form of skin abscesses potentially linked to compounded preservative-free methylprednisolone 80mg/ml 10 ml vials. ",5/28/2013,"05/28/2013",12/11/2013,"12/11/2013"
"Drugs",65479,"Ongoing","Main Street Family Pharmacy, LLC","Newbern","TN","US","Voluntary: Firm Initiated","Telephone","nationwide, specifically: AK, AL, AZ, CA, CO, CT, DC, FL, GA, HI, IL, IN, KS, KY, LA, MA, MD, MN, MO, MS, NC, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, SC, TN, TX, UT, VA, WA, WI, and WV","D-094-2014","Class II","Estradiol Pellets 31mg, Main Street Compounding Pharmacy, 126 East Main Street, Newbern, TN 38059, 888-658-6200","all codes distributed prior to and including 05/23/2013",".","7 units","The firm received seven reports of adverse reactions in the form of skin abscesses potentially linked to compounded preservative-free methylprednisolone 80mg/ml 10 ml vials. ",5/28/2013,"05/28/2013",12/11/2013,"12/11/2013"
"Drugs",65479,"Ongoing","Main Street Family Pharmacy, LLC","Newbern","TN","US","Voluntary: Firm Initiated","Telephone","nationwide, specifically: AK, AL, AZ, CA, CO, CT, DC, FL, GA, HI, IL, IN, KS, KY, LA, MA, MD, MN, MO, MS, NC, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, SC, TN, TX, UT, VA, WA, WI, and WV","D-301-2014","Class II","Testosterone Pellets 200mg, Main Street Compounding Pharmacy, 126 East Main Street, Newbern, TN 38059, 888-658-6200","all codes distributed prior to and including 05/23/2013",".","1250 units","The firm received seven reports of adverse reactions in the form of skin abscesses potentially linked to compounded preservative-free methylprednisolone 80mg/ml 10 ml vials. ",5/28/2013,"05/28/2013",12/11/2013,"12/11/2013"
"Drugs",65479,"Ongoing","Main Street Family Pharmacy, LLC","Newbern","TN","US","Voluntary: Firm Initiated","Telephone","nationwide, specifically: AK, AL, AZ, CA, CO, CT, DC, FL, GA, HI, IL, IN, KS, KY, LA, MA, MD, MN, MO, MS, NC, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, SC, TN, TX, UT, VA, WA, WI, and WV","D-090-2014","Class II","Estradiol Pellets 12.5mg, Main Street Compounding Pharmacy, 126 East Main Street, Newbern, TN 38059, 888-658-6200","all codes distributed prior to and including 05/23/2013",".","334 units","The firm received seven reports of adverse reactions in the form of skin abscesses potentially linked to compounded preservative-free methylprednisolone 80mg/ml 10 ml vials. ",5/28/2013,"05/28/2013",12/11/2013,"12/11/2013"
"Drugs",65479,"Ongoing","Main Street Family Pharmacy, LLC","Newbern","TN","US","Voluntary: Firm Initiated","Telephone","nationwide, specifically: AK, AL, AZ, CA, CO, CT, DC, FL, GA, HI, IL, IN, KS, KY, LA, MA, MD, MN, MO, MS, NC, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, SC, TN, TX, UT, VA, WA, WI, and WV","D-160-2014","Class II","Lido 4%/Phenyl 1%, Main Street Compounding Pharmacy, 126 East Main Street, Newbern, TN 38059, 888-658-6200","all codes distributed prior to and including 05/23/2013",".","8 units","The firm received seven reports of adverse reactions in the form of skin abscesses potentially linked to compounded preservative-free methylprednisolone 80mg/ml 10 ml vials. ",5/28/2013,"05/28/2013",12/11/2013,"12/11/2013"
"Drugs",65479,"Ongoing","Main Street Family Pharmacy, LLC","Newbern","TN","US","Voluntary: Firm Initiated","Telephone","nationwide, specifically: AK, AL, AZ, CA, CO, CT, DC, FL, GA, HI, IL, IN, KS, KY, LA, MA, MD, MN, MO, MS, NC, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, SC, TN, TX, UT, VA, WA, WI, and WV","D-231-2014","Class II","Mic B w/Amp Mix, 50ml Main Street Compounding Pharmacy, 126 East Main Street, Newbern, TN 38059, 888-658-6200","all codes distributed prior to and including 05/23/2013",".","36 units","The firm received seven reports of adverse reactions in the form of skin abscesses potentially linked to compounded preservative-free methylprednisolone 80mg/ml 10 ml vials. ",5/28/2013,"05/28/2013",12/11/2013,"12/11/2013"
"Drugs",65479,"Ongoing","Main Street Family Pharmacy, LLC","Newbern","TN","US","Voluntary: Firm Initiated","Telephone","nationwide, specifically: AK, AL, AZ, CA, CO, CT, DC, FL, GA, HI, IL, IN, KS, KY, LA, MA, MD, MN, MO, MS, NC, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, SC, TN, TX, UT, VA, WA, WI, and WV","D-312-2014","Class II","Triamcinolone Diacetate 40mg 5ml, Main Street Compounding Pharmacy, 126 East Main Street, Newbern, TN 38059, 888-658-6200","all codes distributed prior to and including 05/23/2013",".","48 units","The firm received seven reports of adverse reactions in the form of skin abscesses potentially linked to compounded preservative-free methylprednisolone 80mg/ml 10 ml vials. ",5/28/2013,"05/28/2013",12/11/2013,"12/11/2013"
"Drugs",65479,"Ongoing","Main Street Family Pharmacy, LLC","Newbern","TN","US","Voluntary: Firm Initiated","Telephone","nationwide, specifically: AK, AL, AZ, CA, CO, CT, DC, FL, GA, HI, IL, IN, KS, KY, LA, MA, MD, MN, MO, MS, NC, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, SC, TN, TX, UT, VA, WA, WI, and WV","D-264-2014","Class II","Sermorelin GHRP 9mg/3mg/3mg, Main Street Compounding Pharmacy, 126 East Main Street, Newbern, TN 38059, 888-658-6200","all codes distributed prior to and including 05/23/2013",".","51 units","The firm received seven reports of adverse reactions in the form of skin abscesses potentially linked to compounded preservative-free methylprednisolone 80mg/ml 10 ml vials. ",5/28/2013,"05/28/2013",12/11/2013,"12/11/2013"
"Drugs",65479,"Ongoing","Main Street Family Pharmacy, LLC","Newbern","TN","US","Voluntary: Firm Initiated","Telephone","nationwide, specifically: AK, AL, AZ, CA, CO, CT, DC, FL, GA, HI, IL, IN, KS, KY, LA, MA, MD, MN, MO, MS, NC, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, SC, TN, TX, UT, VA, WA, WI, and WV","D-295-2014","Class II","Testosterone Pellet 112.5mg, Main Street Compounding Pharmacy, 126 East Main Street, Newbern, TN 38059, 888-658-6200","distributed prior to and including 05/23/2013",".","20 units","The firm received seven reports of adverse reactions in the form of skin abscesses potentially linked to compounded preservative-free methylprednisolone 80mg/ml 10 ml vials. ",5/28/2013,"05/28/2013",12/11/2013,"12/11/2013"
"Drugs",65479,"Ongoing","Main Street Family Pharmacy, LLC","Newbern","TN","US","Voluntary: Firm Initiated","Telephone","nationwide, specifically: AK, AL, AZ, CA, CO, CT, DC, FL, GA, HI, IL, IN, KS, KY, LA, MA, MD, MN, MO, MS, NC, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, SC, TN, TX, UT, VA, WA, WI, and WV","D-300-2014","Class II","Testosterone Pellets 125mg, Main Street Compounding Pharmacy, 126 East Main Street, Newbern, TN 38059, 888-658-6200","all codes distributed prior to and including 05/23/2013",".","5 units","The firm received seven reports of adverse reactions in the form of skin abscesses potentially linked to compounded preservative-free methylprednisolone 80mg/ml 10 ml vials. ",5/28/2013,"05/28/2013",12/11/2013,"12/11/2013"
"Drugs",65479,"Ongoing","Main Street Family Pharmacy, LLC","Newbern","TN","US","Voluntary: Firm Initiated","Telephone","nationwide, specifically: AK, AL, AZ, CA, CO, CT, DC, FL, GA, HI, IL, IN, KS, KY, LA, MA, MD, MN, MO, MS, NC, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, SC, TN, TX, UT, VA, WA, WI, and WV","D-048-2014","Class II","B-12/Adenosine 10ml, Main Street Compounding Pharmacy, 126 East Main Street, Newbern, TN 38059, 888-658-6200","all codes distributed prior to and including 05/23/2013",".","4 units","The firm received seven reports of adverse reactions in the form of skin abscesses potentially linked to compounded preservative-free methylprednisolone 80mg/ml 10 ml vials. ",5/28/2013,"05/28/2013",12/11/2013,"12/11/2013"
"Drugs",65479,"Ongoing","Main Street Family Pharmacy, LLC","Newbern","TN","US","Voluntary: Firm Initiated","Telephone","nationwide, specifically: AK, AL, AZ, CA, CO, CT, DC, FL, GA, HI, IL, IN, KS, KY, LA, MA, MD, MN, MO, MS, NC, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, SC, TN, TX, UT, VA, WA, WI, and WV","D-166-2014","Class II","Lincomycin 300 w/lido 10ml, Main Street Compounding Pharmacy, 126 East Main Street, Newbern, TN 38059, 888-658-6200","all codes distributed prior to and including 05/23/2013",".","1533 units","The firm received seven reports of adverse reactions in the form of skin abscesses potentially linked to compounded preservative-free methylprednisolone 80mg/ml 10 ml vials. ",5/28/2013,"05/28/2013",12/11/2013,"12/11/2013"
"Drugs",65479,"Ongoing","Main Street Family Pharmacy, LLC","Newbern","TN","US","Voluntary: Firm Initiated","Telephone","nationwide, specifically: AK, AL, AZ, CA, CO, CT, DC, FL, GA, HI, IL, IN, KS, KY, LA, MA, MD, MN, MO, MS, NC, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, SC, TN, TX, UT, VA, WA, WI, and WV","D-228-2014","Class II","Mic 25/50/50 50ml, Main Street Compounding Pharmacy, 126 East Main Street, Newbern, TN 38059, 888-658-6200","all codes distributed prior to and including 05/23/2013",".","6 units","The firm received seven reports of adverse reactions in the form of skin abscesses potentially linked to compounded preservative-free methylprednisolone 80mg/ml 10 ml vials. ",5/28/2013,"05/28/2013",12/11/2013,"12/11/2013"
"Drugs",65479,"Ongoing","Main Street Family Pharmacy, LLC","Newbern","TN","US","Voluntary: Firm Initiated","Telephone","nationwide, specifically: AK, AL, AZ, CA, CO, CT, DC, FL, GA, HI, IL, IN, KS, KY, LA, MA, MD, MN, MO, MS, NC, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, SC, TN, TX, UT, VA, WA, WI, and WV","D-302-2014","Class II","Testosterone Pellets 220mg, Main Street Compounding Pharmacy, 126 East Main Street, Newbern, TN 38059, 888-658-6200","all codes distributed prior to and including 05/23/2013",".","10 units","The firm received seven reports of adverse reactions in the form of skin abscesses potentially linked to compounded preservative-free methylprednisolone 80mg/ml 10 ml vials. ",5/28/2013,"05/28/2013",12/11/2013,"12/11/2013"
"Drugs",65479,"Ongoing","Main Street Family Pharmacy, LLC","Newbern","TN","US","Voluntary: Firm Initiated","Telephone","nationwide, specifically: AK, AL, AZ, CA, CO, CT, DC, FL, GA, HI, IL, IN, KS, KY, LA, MA, MD, MN, MO, MS, NC, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, SC, TN, TX, UT, VA, WA, WI, and WV","D-163-2014","Class II","Lidocaine 2% 30ml, Main Street Compounding Pharmacy, 126 East Main Street, Newbern, TN 38059, 888-658-6200","all codes distributed prior to and including 05/23/2013",".","93 units","The firm received seven reports of adverse reactions in the form of skin abscesses potentially linked to compounded preservative-free methylprednisolone 80mg/ml 10 ml vials. ",5/28/2013,"05/28/2013",12/11/2013,"12/11/2013"
"Drugs",65479,"Ongoing","Main Street Family Pharmacy, LLC","Newbern","TN","US","Voluntary: Firm Initiated","Telephone","nationwide, specifically: AK, AL, AZ, CA, CO, CT, DC, FL, GA, HI, IL, IN, KS, KY, LA, MA, MD, MN, MO, MS, NC, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, SC, TN, TX, UT, VA, WA, WI, and WV","D-130-2014","Class II","HCG 290 iu prefilled syringes, Main Street Compounding Pharmacy, 126 East Main Street, Newbern, TN 38059, 888-658-6200","all codes distributed prior to and including 05/23/2013",".","4750 units","The firm received seven reports of adverse reactions in the form of skin abscesses potentially linked to compounded preservative-free methylprednisolone 80mg/ml 10 ml vials. ",5/28/2013,"05/28/2013",12/11/2013,"12/11/2013"
"Drugs",65479,"Ongoing","Main Street Family Pharmacy, LLC","Newbern","TN","US","Voluntary: Firm Initiated","Telephone","nationwide, specifically: AK, AL, AZ, CA, CO, CT, DC, FL, GA, HI, IL, IN, KS, KY, LA, MA, MD, MN, MO, MS, NC, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, SC, TN, TX, UT, VA, WA, WI, and WV","D-224-2014","Class II","Methylprednisolone 80mg w/lidocaine 10ml, Main Street Compounding Pharmacy, 126 East Main Street, Newbern, TN 38059, 888-658-6200","all codes distributed prior to and including 05/23/2013",".","2235 units","The firm received seven reports of adverse reactions in the form of skin abscesses potentially linked to compounded preservative-free methylprednisolone 80mg/ml 10 ml vials. ",5/28/2013,"05/28/2013",12/11/2013,"12/11/2013"
"Drugs",65479,"Ongoing","Main Street Family Pharmacy, LLC","Newbern","TN","US","Voluntary: Firm Initiated","Telephone","nationwide, specifically: AK, AL, AZ, CA, CO, CT, DC, FL, GA, HI, IL, IN, KS, KY, LA, MA, MD, MN, MO, MS, NC, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, SC, TN, TX, UT, VA, WA, WI, and WV","D-187-2014","Class II","Lipotropic 50ml, Main Street Compounding Pharmacy, 126 East Main Street, Newbern, TN 38059, 888-658-6200","all codes distributed prior to and including 05/23/2013",".","411 units","The firm received seven reports of adverse reactions in the form of skin abscesses potentially linked to compounded preservative-free methylprednisolone 80mg/ml 10 ml vials. ",5/28/2013,"05/28/2013",12/11/2013,"12/11/2013"
"Drugs",65479,"Ongoing","Main Street Family Pharmacy, LLC","Newbern","TN","US","Voluntary: Firm Initiated","Telephone","nationwide, specifically: AK, AL, AZ, CA, CO, CT, DC, FL, GA, HI, IL, IN, KS, KY, LA, MA, MD, MN, MO, MS, NC, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, SC, TN, TX, UT, VA, WA, WI, and WV","D-239-2014","Class II","Mic Ultra 50ml- Sulfur Free w/Lido, Main Street Compounding Pharmacy, 126 East Main Street, Newbern, TN 38059, 888-658-6200","all codes distributed prior to and including 05/23/2013",".","18 units","The firm received seven reports of adverse reactions in the form of skin abscesses potentially linked to compounded preservative-free methylprednisolone 80mg/ml 10 ml vials. ",5/28/2013,"05/28/2013",12/11/2013,"12/11/2013"
"Drugs",65479,"Ongoing","Main Street Family Pharmacy, LLC","Newbern","TN","US","Voluntary: Firm Initiated","Telephone","nationwide, specifically: AK, AL, AZ, CA, CO, CT, DC, FL, GA, HI, IL, IN, KS, KY, LA, MA, MD, MN, MO, MS, NC, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, SC, TN, TX, UT, VA, WA, WI, and WV","D-127-2014","Class II","HCG 270 iu prefilled syringes, Main Street Compounding Pharmacy, 126 East Main Street, Newbern, TN 38059, 888-658-6200","all codes distributed prior to and including 05/23/2013",".","4648 units","The firm received seven reports of adverse reactions in the form of skin abscesses potentially linked to compounded preservative-free methylprednisolone 80mg/ml 10 ml vials. ",5/28/2013,"05/28/2013",12/11/2013,"12/11/2013"
"Drugs",65479,"Ongoing","Main Street Family Pharmacy, LLC","Newbern","TN","US","Voluntary: Firm Initiated","Telephone","nationwide, specifically: AK, AL, AZ, CA, CO, CT, DC, FL, GA, HI, IL, IN, KS, KY, LA, MA, MD, MN, MO, MS, NC, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, SC, TN, TX, UT, VA, WA, WI, and WV","D-050-2014","Class II","B-Complex 100 30ml (PF), Main Street Compounding Pharmacy, 126 East Main Street, Newbern, TN 38059, 888-658-6200","all codes distributed prior to and including 05/23/2013",".","35 units","The firm received seven reports of adverse reactions in the form of skin abscesses potentially linked to compounded preservative-free methylprednisolone 80mg/ml 10 ml vials. ",5/28/2013,"05/28/2013",12/11/2013,"12/11/2013"
"Drugs",65479,"Ongoing","Main Street Family Pharmacy, LLC","Newbern","TN","US","Voluntary: Firm Initiated","Telephone","nationwide, specifically: AK, AL, AZ, CA, CO, CT, DC, FL, GA, HI, IL, IN, KS, KY, LA, MA, MD, MN, MO, MS, NC, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, SC, TN, TX, UT, VA, WA, WI, and WV","D-043-2014","Class II","B-12 (Methyl) 30ml, Main Street Compounding Pharmacy, 126 East Main Street, Newbern, TN 38059, 888-658-6200","all codes distributed prior to and including 05/23/2013",".","7 units","The firm received seven reports of adverse reactions in the form of skin abscesses potentially linked to compounded preservative-free methylprednisolone 80mg/ml 10 ml vials. ",5/28/2013,"05/28/2013",12/11/2013,"12/11/2013"
"Drugs",65479,"Ongoing","Main Street Family Pharmacy, LLC","Newbern","TN","US","Voluntary: Firm Initiated","Telephone","nationwide, specifically: AK, AL, AZ, CA, CO, CT, DC, FL, GA, HI, IL, IN, KS, KY, LA, MA, MD, MN, MO, MS, NC, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, SC, TN, TX, UT, VA, WA, WI, and WV","D-204-2014","Class II","Mesotherapy, Main Street Compounding Pharmacy, 126 East Main Street, Newbern, TN 38059, 888-658-6200","all codes distributed prior to and including 05/23/2013",".","2 units","The firm received seven reports of adverse reactions in the form of skin abscesses potentially linked to compounded preservative-free methylprednisolone 80mg/ml 10 ml vials. ",5/28/2013,"05/28/2013",12/11/2013,"12/11/2013"
"Drugs",65479,"Ongoing","Main Street Family Pharmacy, LLC","Newbern","TN","US","Voluntary: Firm Initiated","Telephone","nationwide, specifically: AK, AL, AZ, CA, CO, CT, DC, FL, GA, HI, IL, IN, KS, KY, LA, MA, MD, MN, MO, MS, NC, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, SC, TN, TX, UT, VA, WA, WI, and WV","D-246-2014","Class II","Mitomycin 20mg, Main Street Compounding Pharmacy, 126 East Main Street, Newbern, TN 38059, 888-658-6200","all codes distributed prior to and including 05/23/2013",".","102 units","The firm received seven reports of adverse reactions in the form of skin abscesses potentially linked to compounded preservative-free methylprednisolone 80mg/ml 10 ml vials. ",5/28/2013,"05/28/2013",12/11/2013,"12/11/2013"
"Drugs",65479,"Ongoing","Main Street Family Pharmacy, LLC","Newbern","TN","US","Voluntary: Firm Initiated","Telephone","nationwide, specifically: AK, AL, AZ, CA, CO, CT, DC, FL, GA, HI, IL, IN, KS, KY, LA, MA, MD, MN, MO, MS, NC, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, SC, TN, TX, UT, VA, WA, WI, and WV","D-124-2014","Class II","HCG 250 iu prefilled syringes, Main Street Compounding Pharmacy, 126 East Main Street, Newbern, TN 38059, 888-658-6200","all codes distributed prior to and including 05/23/2013",".","5777 units","The firm received seven reports of adverse reactions in the form of skin abscesses potentially linked to compounded preservative-free methylprednisolone 80mg/ml 10 ml vials. ",5/28/2013,"05/28/2013",12/11/2013,"12/11/2013"
"Drugs",65479,"Ongoing","Main Street Family Pharmacy, LLC","Newbern","TN","US","Voluntary: Firm Initiated","Telephone","nationwide, specifically: AK, AL, AZ, CA, CO, CT, DC, FL, GA, HI, IL, IN, KS, KY, LA, MA, MD, MN, MO, MS, NC, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, SC, TN, TX, UT, VA, WA, WI, and WV","D-121-2014","Class II","HCG 220 iu prefilled syringes, Main Street Compounding Pharmacy, 126 East Main Street, Newbern, TN 38059, 888-658-6200","all codes distributed prior to and including 05/23/2013",".","4797 units","The firm received seven reports of adverse reactions in the form of skin abscesses potentially linked to compounded preservative-free methylprednisolone 80mg/ml 10 ml vials. ",5/28/2013,"05/28/2013",12/11/2013,"12/11/2013"
"Drugs",65479,"Ongoing","Main Street Family Pharmacy, LLC","Newbern","TN","US","Voluntary: Firm Initiated","Telephone","nationwide, specifically: AK, AL, AZ, CA, CO, CT, DC, FL, GA, HI, IL, IN, KS, KY, LA, MA, MD, MN, MO, MS, NC, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, SC, TN, TX, UT, VA, WA, WI, and WV","D-039-2014","Class II","Aminophylline 250mg 10ml, Main Street Compounding Pharmacy, 126 East Main Street, Newbern, TN 38059, 888-658-6200","all codes distributed prior to and including 05/23/2013",".","6 units","The firm received seven reports of adverse reactions in the form of skin abscesses potentially linked to compounded preservative-free methylprednisolone 80mg/ml 10 ml vials. ",5/28/2013,"05/28/2013",12/11/2013,"12/11/2013"
"Drugs",65479,"Ongoing","Main Street Family Pharmacy, LLC","Newbern","TN","US","Voluntary: Firm Initiated","Telephone","nationwide, specifically: AK, AL, AZ, CA, CO, CT, DC, FL, GA, HI, IL, IN, KS, KY, LA, MA, MD, MN, MO, MS, NC, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, SC, TN, TX, UT, VA, WA, WI, and WV","D-126-2014","Class II","HCG 260 iu prefilled syringes, Main Street Compounding Pharmacy, 126 East Main Street, Newbern, TN 38059, 888-658-6200","all codes distributed prior to and including 05/23/2013",".","6 units","The firm received seven reports of adverse reactions in the form of skin abscesses potentially linked to compounded preservative-free methylprednisolone 80mg/ml 10 ml vials. ",5/28/2013,"05/28/2013",12/11/2013,"12/11/2013"
"Drugs",65479,"Ongoing","Main Street Family Pharmacy, LLC","Newbern","TN","US","Voluntary: Firm Initiated","Telephone","nationwide, specifically: AK, AL, AZ, CA, CO, CT, DC, FL, GA, HI, IL, IN, KS, KY, LA, MA, MD, MN, MO, MS, NC, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, SC, TN, TX, UT, VA, WA, WI, and WV","D-189-2014","Class II","Lipotropic 50ml w/o methionine, Main Street Compounding Pharmacy, 126 East Main Street, Newbern, TN 38059, 888-658-6200","all codes distributed prior to and including 05/23/2013",".","441 units","The firm received seven reports of adverse reactions in the form of skin abscesses potentially linked to compounded preservative-free methylprednisolone 80mg/ml 10 ml vials. ",5/28/2013,"05/28/2013",12/11/2013,"12/11/2013"
"Drugs",65479,"Ongoing","Main Street Family Pharmacy, LLC","Newbern","TN","US","Voluntary: Firm Initiated","Telephone","nationwide, specifically: AK, AL, AZ, CA, CO, CT, DC, FL, GA, HI, IL, IN, KS, KY, LA, MA, MD, MN, MO, MS, NC, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, SC, TN, TX, UT, VA, WA, WI, and WV","D-218-2014","Class II","Methylprednisolone 40mg w/lidocaine 1ml, Main Street Compounding Pharmacy, 126 East Main Street, Newbern, TN 38059, 888-658-6200","all codes distributed prior to and including 05/23/2013",".","247 units","The firm received seven reports of adverse reactions in the form of skin abscesses potentially linked to compounded preservative-free methylprednisolone 80mg/ml 10 ml vials. ",5/28/2013,"05/28/2013",12/11/2013,"12/11/2013"
"Drugs",65479,"Ongoing","Main Street Family Pharmacy, LLC","Newbern","TN","US","Voluntary: Firm Initiated","Telephone","nationwide, specifically: AK, AL, AZ, CA, CO, CT, DC, FL, GA, HI, IL, IN, KS, KY, LA, MA, MD, MN, MO, MS, NC, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, SC, TN, TX, UT, VA, WA, WI, and WV","D-068-2014","Class II","Carnitine 250mg/ml, Main Street Compounding Pharmacy, 126 East Main Street, Newbern, TN 38059, 888-658-6200","all codes distributed prior to and including 05/23/2013",".","30 units","The firm received seven reports of adverse reactions in the form of skin abscesses potentially linked to compounded preservative-free methylprednisolone 80mg/ml 10 ml vials. ",5/28/2013,"05/28/2013",12/11/2013,"12/11/2013"
"Drugs",65479,"Ongoing","Main Street Family Pharmacy, LLC","Newbern","TN","US","Voluntary: Firm Initiated","Telephone","nationwide, specifically: AK, AL, AZ, CA, CO, CT, DC, FL, GA, HI, IL, IN, KS, KY, LA, MA, MD, MN, MO, MS, NC, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, SC, TN, TX, UT, VA, WA, WI, and WV","D-298-2014","Class II","Testosterone Pellet 87.5mg, Main Street Compounding Pharmacy, 126 East Main Street, Newbern, TN 38059, 888-658-6200","all codes distributed prior to and including 05/23/2013",".","24 units","The firm received seven reports of adverse reactions in the form of skin abscesses potentially linked to compounded preservative-free methylprednisolone 80mg/ml 10 ml vials. ",5/28/2013,"05/28/2013",12/11/2013,"12/11/2013"
"Drugs",65479,"Ongoing","Main Street Family Pharmacy, LLC","Newbern","TN","US","Voluntary: Firm Initiated","Telephone","nationwide, specifically: AK, AL, AZ, CA, CO, CT, DC, FL, GA, HI, IL, IN, KS, KY, LA, MA, MD, MN, MO, MS, NC, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, SC, TN, TX, UT, VA, WA, WI, and WV","D-089-2014","Class II","Estradiol Pellets 10mg, Main Street Compounding Pharmacy, 126 East Main Street, Newbern, TN 38059, 888-658-6200","all codes distributed prior to and including 05/23/2013",".","250 units","The firm received seven reports of adverse reactions in the form of skin abscesses potentially linked to compounded preservative-free methylprednisolone 80mg/ml 10 ml vials. ",5/28/2013,"05/28/2013",12/11/2013,"12/11/2013"
"Drugs",65479,"Ongoing","Main Street Family Pharmacy, LLC","Newbern","TN","US","Voluntary: Firm Initiated","Telephone","nationwide, specifically: AK, AL, AZ, CA, CO, CT, DC, FL, GA, HI, IL, IN, KS, KY, LA, MA, MD, MN, MO, MS, NC, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, SC, TN, TX, UT, VA, WA, WI, and WV","D-140-2014","Class II","HCG 380 iu prefilled syringes, Main Street Compounding Pharmacy, 126 East Main Street, Newbern, TN 38059, 888-658-6200","all codes distributed prior to and including 05/23/2013",".","56 units","The firm received seven reports of adverse reactions in the form of skin abscesses potentially linked to compounded preservative-free methylprednisolone 80mg/ml 10 ml vials. ",5/28/2013,"05/28/2013",12/11/2013,"12/11/2013"
"Drugs",65479,"Ongoing","Main Street Family Pharmacy, LLC","Newbern","TN","US","Voluntary: Firm Initiated","Telephone","nationwide, specifically: AK, AL, AZ, CA, CO, CT, DC, FL, GA, HI, IL, IN, KS, KY, LA, MA, MD, MN, MO, MS, NC, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, SC, TN, TX, UT, VA, WA, WI, and WV","D-213-2014","Class II","Methylprednisolone 40 w/lidocaine 10ml, Main Street Compounding Pharmacy, 126 East Main Street, Newbern, TN 38059, 888-658-6200","all codes distributed prior to and including 05/23/2013",".","2538 units","The firm received seven reports of adverse reactions in the form of skin abscesses potentially linked to compounded preservative-free methylprednisolone 80mg/ml 10 ml vials. ",5/28/2013,"05/28/2013",12/11/2013,"12/11/2013"
"Drugs",65479,"Ongoing","Main Street Family Pharmacy, LLC","Newbern","TN","US","Voluntary: Firm Initiated","Telephone","nationwide, specifically: AK, AL, AZ, CA, CO, CT, DC, FL, GA, HI, IL, IN, KS, KY, LA, MA, MD, MN, MO, MS, NC, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, SC, TN, TX, UT, VA, WA, WI, and WV","D-026-2014","Class II","Acetylcystein 10% 100mg/ml 4ml, Main Street Compounding Pharmacy, 126 East Main Street, Newbern, TN 38059, 888-658-6200","all codes distributed prior to and including 05/23/2013",".","1 unit","The firm received seven reports of adverse reactions in the form of skin abscesses potentially linked to compounded preservative-free methylprednisolone 80mg/ml 10 ml vials. ",5/28/2013,"05/28/2013",12/11/2013,"12/11/2013"
"Drugs",65479,"Ongoing","Main Street Family Pharmacy, LLC","Newbern","TN","US","Voluntary: Firm Initiated","Telephone","nationwide, specifically: AK, AL, AZ, CA, CO, CT, DC, FL, GA, HI, IL, IN, KS, KY, LA, MA, MD, MN, MO, MS, NC, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, SC, TN, TX, UT, VA, WA, WI, and WV","D-253-2014","Class II","Phosphatidylcholine/Deoxycholic Acid 50ml, Main Street Compounding Pharmacy, 126 East Main Street, Newbern, TN 38059, 888-658-6200","all codes distributed prior to and including 05/23/2013",".","11 units","The firm received seven reports of adverse reactions in the form of skin abscesses potentially linked to compounded preservative-free methylprednisolone 80mg/ml 10 ml vials. ",5/28/2013,"05/28/2013",12/11/2013,"12/11/2013"
"Drugs",65479,"Ongoing","Main Street Family Pharmacy, LLC","Newbern","TN","US","Voluntary: Firm Initiated","Telephone","nationwide, specifically: AK, AL, AZ, CA, CO, CT, DC, FL, GA, HI, IL, IN, KS, KY, LA, MA, MD, MN, MO, MS, NC, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, SC, TN, TX, UT, VA, WA, WI, and WV","D-203-2014","Class II","Medroxyprogesterone 150mg w/lid, 1ml Main Street Compounding Pharmacy, 126 East Main Street, Newbern, TN 38059, 888-658-6200","all codes distributed prior to and including 05/23/2013",".","4 units","The firm received seven reports of adverse reactions in the form of skin abscesses potentially linked to compounded preservative-free methylprednisolone 80mg/ml 10 ml vials. ",5/28/2013,"05/28/2013",12/11/2013,"12/11/2013"
"Drugs",65479,"Ongoing","Main Street Family Pharmacy, LLC","Newbern","TN","US","Voluntary: Firm Initiated","Telephone","nationwide, specifically: AK, AL, AZ, CA, CO, CT, DC, FL, GA, HI, IL, IN, KS, KY, LA, MA, MD, MN, MO, MS, NC, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, SC, TN, TX, UT, VA, WA, WI, and WV","D-047-2014","Class II","B-12 PFS, Main Street Compounding Pharmacy, 126 East Main Street, Newbern, TN 38059, 888-658-6200","all codes distributed prior to and including 05/23/2013",".","10 units","The firm received seven reports of adverse reactions in the form of skin abscesses potentially linked to compounded preservative-free methylprednisolone 80mg/ml 10 ml vials. ",5/28/2013,"05/28/2013",12/11/2013,"12/11/2013"
"Drugs",65479,"Ongoing","Main Street Family Pharmacy, LLC","Newbern","TN","US","Voluntary: Firm Initiated","Telephone","nationwide, specifically: AK, AL, AZ, CA, CO, CT, DC, FL, GA, HI, IL, IN, KS, KY, LA, MA, MD, MN, MO, MS, NC, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, SC, TN, TX, UT, VA, WA, WI, and WV","D-092-2014","Class II","Estradiol Pellets 15mg, Main Street Compounding Pharmacy, 126 East Main Street, Newbern, TN 38059, 888-658-6200","all codes distributed prior to and including 05/23/2013",".","19 units","The firm received seven reports of adverse reactions in the form of skin abscesses potentially linked to compounded preservative-free methylprednisolone 80mg/ml 10 ml vials. ",5/28/2013,"05/28/2013",12/11/2013,"12/11/2013"
"Drugs",65479,"Ongoing","Main Street Family Pharmacy, LLC","Newbern","TN","US","Voluntary: Firm Initiated","Telephone","nationwide, specifically: AK, AL, AZ, CA, CO, CT, DC, FL, GA, HI, IL, IN, KS, KY, LA, MA, MD, MN, MO, MS, NC, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, SC, TN, TX, UT, VA, WA, WI, and WV","D-149-2014","Class II","HCG 60 iu prefilled syringes, Main Street Compounding Pharmacy, 126 East Main Street, Newbern, TN 38059, 888-658-6200","all codes distributed prior to and including 05/23/2013",".","3 units","The firm received seven reports of adverse reactions in the form of skin abscesses potentially linked to compounded preservative-free methylprednisolone 80mg/ml 10 ml vials. ",5/28/2013,"05/28/2013",12/11/2013,"12/11/2013"
"Drugs",65479,"Ongoing","Main Street Family Pharmacy, LLC","Newbern","TN","US","Voluntary: Firm Initiated","Telephone","nationwide, specifically: AK, AL, AZ, CA, CO, CT, DC, FL, GA, HI, IL, IN, KS, KY, LA, MA, MD, MN, MO, MS, NC, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, SC, TN, TX, UT, VA, WA, WI, and WV","D-216-2014","Class II","Methylprednisolone 40mg PF 1ml, Main Street Compounding Pharmacy, 126 East Main Street, Newbern, TN 38059, 888-658-6200","all codes distributed prior to and including 05/23/2013",".","2084 units","The firm received seven reports of adverse reactions in the form of skin abscesses potentially linked to compounded preservative-free methylprednisolone 80mg/ml 10 ml vials. ",5/28/2013,"05/28/2013",12/11/2013,"12/11/2013"
"Drugs",65479,"Ongoing","Main Street Family Pharmacy, LLC","Newbern","TN","US","Voluntary: Firm Initiated","Telephone","nationwide, specifically: AK, AL, AZ, CA, CO, CT, DC, FL, GA, HI, IL, IN, KS, KY, LA, MA, MD, MN, MO, MS, NC, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, SC, TN, TX, UT, VA, WA, WI, and WV","D-040-2014","Class II","Aminophylline 25mg/ml 10ml, Main Street Compounding Pharmacy, 126 East Main Street, Newbern, TN 38059, 888-658-6200","all codes distributed prior to and including 05/23/2013",".","25 units","The firm received seven reports of adverse reactions in the form of skin abscesses potentially linked to compounded preservative-free methylprednisolone 80mg/ml 10 ml vials. ",5/28/2013,"05/28/2013",12/11/2013,"12/11/2013"
"Drugs",65479,"Ongoing","Main Street Family Pharmacy, LLC","Newbern","TN","US","Voluntary: Firm Initiated","Telephone","nationwide, specifically: AK, AL, AZ, CA, CO, CT, DC, FL, GA, HI, IL, IN, KS, KY, LA, MA, MD, MN, MO, MS, NC, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, SC, TN, TX, UT, VA, WA, WI, and WV","D-307-2014","Class II","Testosterone Pellets 75mg, Main Street Compounding Pharmacy, 126 East Main Street, Newbern, TN 38059, 888-658-6200","all codes distributed prior to and including 05/23/2013",".","31 units","The firm received seven reports of adverse reactions in the form of skin abscesses potentially linked to compounded preservative-free methylprednisolone 80mg/ml 10 ml vials. ",5/28/2013,"05/28/2013",12/11/2013,"12/11/2013"
"Drugs",65479,"Ongoing","Main Street Family Pharmacy, LLC","Newbern","TN","US","Voluntary: Firm Initiated","Telephone","nationwide, specifically: AK, AL, AZ, CA, CO, CT, DC, FL, GA, HI, IL, IN, KS, KY, LA, MA, MD, MN, MO, MS, NC, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, SC, TN, TX, UT, VA, WA, WI, and WV","D-142-2014","Class II","HCG 40,000u, Main Street Compounding Pharmacy, 126 East Main Street, Newbern, TN 38059, 888-658-6200","all codes distributed prior to and including 05/23/2013",".","11 units","The firm received seven reports of adverse reactions in the form of skin abscesses potentially linked to compounded preservative-free methylprednisolone 80mg/ml 10 ml vials. ",5/28/2013,"05/28/2013",12/11/2013,"12/11/2013"
"Drugs",65479,"Ongoing","Main Street Family Pharmacy, LLC","Newbern","TN","US","Voluntary: Firm Initiated","Telephone","nationwide, specifically: AK, AL, AZ, CA, CO, CT, DC, FL, GA, HI, IL, IN, KS, KY, LA, MA, MD, MN, MO, MS, NC, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, SC, TN, TX, UT, VA, WA, WI, and WV","D-313-2014","Class II","Triamcinolone PF 40mg 2ml, Main Street Compounding Pharmacy, 126 East Main Street, Newbern, TN 38059, 888-658-6200","all codes distributed prior to and including 05/23/2013",".","4 units","The firm received seven reports of adverse reactions in the form of skin abscesses potentially linked to compounded preservative-free methylprednisolone 80mg/ml 10 ml vials. ",5/28/2013,"05/28/2013",12/11/2013,"12/11/2013"
"Drugs",65479,"Ongoing","Main Street Family Pharmacy, LLC","Newbern","TN","US","Voluntary: Firm Initiated","Telephone","nationwide, specifically: AK, AL, AZ, CA, CO, CT, DC, FL, GA, HI, IL, IN, KS, KY, LA, MA, MD, MN, MO, MS, NC, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, SC, TN, TX, UT, VA, WA, WI, and WV","D-141-2014","Class II","HCG 390iu prefilled syringes, Main Street Compounding Pharmacy, 126 East Main Street, Newbern, TN 38059, 888-658-6200","all codes distributed prior to and including 05/23/2013",".","604 units","The firm received seven reports of adverse reactions in the form of skin abscesses potentially linked to compounded preservative-free methylprednisolone 80mg/ml 10 ml vials. ",5/28/2013,"05/28/2013",12/11/2013,"12/11/2013"
"Drugs",65479,"Ongoing","Main Street Family Pharmacy, LLC","Newbern","TN","US","Voluntary: Firm Initiated","Telephone","nationwide, specifically: AK, AL, AZ, CA, CO, CT, DC, FL, GA, HI, IL, IN, KS, KY, LA, MA, MD, MN, MO, MS, NC, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, SC, TN, TX, UT, VA, WA, WI, and WV","D-064-2014","Class II","Brompheniramine 10ml, Main Street Compounding Pharmacy, 126 East Main Street, Newbern, TN 38059, 888-658-6200","all codes distributed prior to and including 05/23/2013",".","415 units","The firm received seven reports of adverse reactions in the form of skin abscesses potentially linked to compounded preservative-free methylprednisolone 80mg/ml 10 ml vials. ",5/28/2013,"05/28/2013",12/11/2013,"12/11/2013"
"Drugs",65479,"Ongoing","Main Street Family Pharmacy, LLC","Newbern","TN","US","Voluntary: Firm Initiated","Telephone","nationwide, specifically: AK, AL, AZ, CA, CO, CT, DC, FL, GA, HI, IL, IN, KS, KY, LA, MA, MD, MN, MO, MS, NC, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, SC, TN, TX, UT, VA, WA, WI, and WV","D-116-2014","Class II","HCG 200 iu prefilled syringes, Main Street Compounding Pharmacy, 126 East Main Street, Newbern, TN 38059, 888-658-6200","all codes distributed prior to and including 05/23/2013",".","2692 units","The firm received seven reports of adverse reactions in the form of skin abscesses potentially linked to compounded preservative-free methylprednisolone 80mg/ml 10 ml vials. ",5/28/2013,"05/28/2013",12/11/2013,"12/11/2013"
"Drugs",65479,"Ongoing","Main Street Family Pharmacy, LLC","Newbern","TN","US","Voluntary: Firm Initiated","Telephone","nationwide, specifically: AK, AL, AZ, CA, CO, CT, DC, FL, GA, HI, IL, IN, KS, KY, LA, MA, MD, MN, MO, MS, NC, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, SC, TN, TX, UT, VA, WA, WI, and WV","D-281-2014","Class II","Test Cypionate 20mg/ml 5ml, Main Street Compounding Pharmacy, 126 East Main Street, Newbern, TN 38059, 888-658-6200","all codes distributed prior to and including 05/23/2013",".","1 unit","The firm received seven reports of adverse reactions in the form of skin abscesses potentially linked to compounded preservative-free methylprednisolone 80mg/ml 10 ml vials. ",5/28/2013,"05/28/2013",12/11/2013,"12/11/2013"
"Drugs",65479,"Ongoing","Main Street Family Pharmacy, LLC","Newbern","TN","US","Voluntary: Firm Initiated","Telephone","nationwide, specifically: AK, AL, AZ, CA, CO, CT, DC, FL, GA, HI, IL, IN, KS, KY, LA, MA, MD, MN, MO, MS, NC, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, SC, TN, TX, UT, VA, WA, WI, and WV","D-244-2014","Class II","Minoxidil 15% 60ml, Main Street Compounding Pharmacy, 126 East Main Street, Newbern, TN 38059, 888-658-6200","all codes distributed prior to and including 05/23/2013",".","1 unit","The firm received seven reports of adverse reactions in the form of skin abscesses potentially linked to compounded preservative-free methylprednisolone 80mg/ml 10 ml vials. ",5/28/2013,"05/28/2013",12/11/2013,"12/11/2013"
"Drugs",65479,"Ongoing","Main Street Family Pharmacy, LLC","Newbern","TN","US","Voluntary: Firm Initiated","Telephone","nationwide, specifically: AK, AL, AZ, CA, CO, CT, DC, FL, GA, HI, IL, IN, KS, KY, LA, MA, MD, MN, MO, MS, NC, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, SC, TN, TX, UT, VA, WA, WI, and WV","D-041-2014","Class II","Ascorbic Acid 500mg/ml 50ml, Main Street Compounding Pharmacy, 126 East Main Street, Newbern, TN 38059, 888-658-6200","all codes distributed prior to and including 05/23/2013",".","894 units","The firm received seven reports of adverse reactions in the form of skin abscesses potentially linked to compounded preservative-free methylprednisolone 80mg/ml 10 ml vials. ",5/28/2013,"05/28/2013",12/11/2013,"12/11/2013"
"Drugs",65479,"Ongoing","Main Street Family Pharmacy, LLC","Newbern","TN","US","Voluntary: Firm Initiated","Telephone","nationwide, specifically: AK, AL, AZ, CA, CO, CT, DC, FL, GA, HI, IL, IN, KS, KY, LA, MA, MD, MN, MO, MS, NC, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, SC, TN, TX, UT, VA, WA, WI, and WV","D-129-2014","Class II","HCG 280 iu prefilled syringes, Main Street Compounding Pharmacy, 126 East Main Street, Newbern, TN 38059, 888-658-6200","all codes distributed prior to and including 05/23/2013",".","2873 units","The firm received seven reports of adverse reactions in the form of skin abscesses potentially linked to compounded preservative-free methylprednisolone 80mg/ml 10 ml vials. ",5/28/2013,"05/28/2013",12/11/2013,"12/11/2013"
"Drugs",65479,"Ongoing","Main Street Family Pharmacy, LLC","Newbern","TN","US","Voluntary: Firm Initiated","Telephone","nationwide, specifically: AK, AL, AZ, CA, CO, CT, DC, FL, GA, HI, IL, IN, KS, KY, LA, MA, MD, MN, MO, MS, NC, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, SC, TN, TX, UT, VA, WA, WI, and WV","D-234-2014","Class II","Mic Combo w/methyl 30ml, Main Street Compounding Pharmacy, 126 East Main Street, Newbern, TN 38059, 888-658-6200","all codes distributed prior to and including 05/23/2013",".","2 units","The firm received seven reports of adverse reactions in the form of skin abscesses potentially linked to compounded preservative-free methylprednisolone 80mg/ml 10 ml vials. ",5/28/2013,"05/28/2013",12/11/2013,"12/11/2013"
"Drugs",65479,"Ongoing","Main Street Family Pharmacy, LLC","Newbern","TN","US","Voluntary: Firm Initiated","Telephone","nationwide, specifically: AK, AL, AZ, CA, CO, CT, DC, FL, GA, HI, IL, IN, KS, KY, LA, MA, MD, MN, MO, MS, NC, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, SC, TN, TX, UT, VA, WA, WI, and WV","D-279-2014","Class II","TCA 30% - 0.8PH 15ml vial, Main Street Compounding Pharmacy, 126 East Main Street, Newbern, TN 38059, 888-658-6200","all codes distributed prior to and including 05/23/2013",".","1 unit","The firm received seven reports of adverse reactions in the form of skin abscesses potentially linked to compounded preservative-free methylprednisolone 80mg/ml 10 ml vials. ",5/28/2013,"05/28/2013",12/11/2013,"12/11/2013"
"Drugs",65479,"Ongoing","Main Street Family Pharmacy, LLC","Newbern","TN","US","Voluntary: Firm Initiated","Telephone","nationwide, specifically: AK, AL, AZ, CA, CO, CT, DC, FL, GA, HI, IL, IN, KS, KY, LA, MA, MD, MN, MO, MS, NC, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, SC, TN, TX, UT, VA, WA, WI, and WV","D-320-2014","Class II","Trypan Blue 0.15% 1ml , Main Street Compounding Pharmacy, 126 East Main Street, Newbern, TN 38059, 888-658-6200","all codes distributed prior to and including 05/23/2013",".","182 units","The firm received seven reports of adverse reactions in the form of skin abscesses potentially linked to compounded preservative-free methylprednisolone 80mg/ml 10 ml vials. ",5/28/2013,"05/28/2013",12/11/2013,"12/11/2013"
"Drugs",65479,"Ongoing","Main Street Family Pharmacy, LLC","Newbern","TN","US","Voluntary: Firm Initiated","Telephone","nationwide, specifically: AK, AL, AZ, CA, CO, CT, DC, FL, GA, HI, IL, IN, KS, KY, LA, MA, MD, MN, MO, MS, NC, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, SC, TN, TX, UT, VA, WA, WI, and WV","D-280-2014","Class II","TCA 30% 30ml vial, Main Street Compounding Pharmacy, 126 East Main Street, Newbern, TN 38059, 888-658-6200","all codes distributed prior to and including 05/23/2013",".","1 units","The firm received seven reports of adverse reactions in the form of skin abscesses potentially linked to compounded preservative-free methylprednisolone 80mg/ml 10 ml vials. ",5/28/2013,"05/28/2013",12/11/2013,"12/11/2013"
"Drugs",65479,"Ongoing","Main Street Family Pharmacy, LLC","Newbern","TN","US","Voluntary: Firm Initiated","Telephone","nationwide, specifically: AK, AL, AZ, CA, CO, CT, DC, FL, GA, HI, IL, IN, KS, KY, LA, MA, MD, MN, MO, MS, NC, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, SC, TN, TX, UT, VA, WA, WI, and WV","D-186-2014","Class II","Lipotropic 30ml, Main Street Compounding Pharmacy, 126 East Main Street, Newbern, TN 38059, 888-658-6200","all codes distributed prior to and including 05/23/2013",".","8 units","The firm received seven reports of adverse reactions in the form of skin abscesses potentially linked to compounded preservative-free methylprednisolone 80mg/ml 10 ml vials. ",5/28/2013,"05/28/2013",12/11/2013,"12/11/2013"
"Drugs",65479,"Ongoing","Main Street Family Pharmacy, LLC","Newbern","TN","US","Voluntary: Firm Initiated","Telephone","nationwide, specifically: AK, AL, AZ, CA, CO, CT, DC, FL, GA, HI, IL, IN, KS, KY, LA, MA, MD, MN, MO, MS, NC, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, SC, TN, TX, UT, VA, WA, WI, and WV","D-288-2014","Class II","Testosterone Cypionate, 200mg 10ml Main Street Compounding Pharmacy, 126 East Main Street, Newbern, TN 38059, 888-658-6200","distributed prior to and including 05/23/2013",".","1158 units","The firm received seven reports of adverse reactions in the form of skin abscesses potentially linked to compounded preservative-free methylprednisolone 80mg/ml 10 ml vials. ",5/28/2013,"05/28/2013",12/11/2013,"12/11/2013"
"Drugs",65479,"Ongoing","Main Street Family Pharmacy, LLC","Newbern","TN","US","Voluntary: Firm Initiated","Telephone","nationwide, specifically: AK, AL, AZ, CA, CO, CT, DC, FL, GA, HI, IL, IN, KS, KY, LA, MA, MD, MN, MO, MS, NC, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, SC, TN, TX, UT, VA, WA, WI, and WV","D-112-2014","Class II","HCG 1500iu PFS, Main Street Compounding Pharmacy, 126 East Main Street, Newbern, TN 38059, 888-658-6200","all codes distributed prior to and including 05/23/2013",".","52 units","The firm received seven reports of adverse reactions in the form of skin abscesses potentially linked to compounded preservative-free methylprednisolone 80mg/ml 10 ml vials. ",5/28/2013,"05/28/2013",12/11/2013,"12/11/2013"
"Drugs",65479,"Ongoing","Main Street Family Pharmacy, LLC","Newbern","TN","US","Voluntary: Firm Initiated","Telephone","nationwide, specifically: AK, AL, AZ, CA, CO, CT, DC, FL, GA, HI, IL, IN, KS, KY, LA, MA, MD, MN, MO, MS, NC, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, SC, TN, TX, UT, VA, WA, WI, and WV","D-059-2014","Class II","Betamethasone 7mg, Main Street Compounding Pharmacy, 126 East Main Street, Newbern, TN 38059, 888-658-6200","all codes distributed prior to and including 05/23/2013",".","932 units","The firm received seven reports of adverse reactions in the form of skin abscesses potentially linked to compounded preservative-free methylprednisolone 80mg/ml 10 ml vials. ",5/28/2013,"05/28/2013",12/11/2013,"12/11/2013"
"Drugs",65479,"Ongoing","Main Street Family Pharmacy, LLC","Newbern","TN","US","Voluntary: Firm Initiated","Telephone","nationwide, specifically: AK, AL, AZ, CA, CO, CT, DC, FL, GA, HI, IL, IN, KS, KY, LA, MA, MD, MN, MO, MS, NC, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, SC, TN, TX, UT, VA, WA, WI, and WV","D-031-2014","Class II","Alprostadil 100mcg/ml 10ml, Main Street Compounding Pharmacy, 126 East Main Street, Newbern, TN 38059, 888-658-6200","all codes distributed prior to and including 05/23/2013",".","8 units","The firm received seven reports of adverse reactions in the form of skin abscesses potentially linked to compounded preservative-free methylprednisolone 80mg/ml 10 ml vials. ",5/28/2013,"05/28/2013",12/11/2013,"12/11/2013"
"Drugs",65479,"Ongoing","Main Street Family Pharmacy, LLC","Newbern","TN","US","Voluntary: Firm Initiated","Telephone","nationwide, specifically: AK, AL, AZ, CA, CO, CT, DC, FL, GA, HI, IL, IN, KS, KY, LA, MA, MD, MN, MO, MS, NC, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, SC, TN, TX, UT, VA, WA, WI, and WV","D-063-2014","Class II","Bi-Mix Papaverine 30 mg Phentolamine 1mg 10ml, Main Street Compounding Pharmacy, 126 East Main Street, Newbern, TN 38059, 888-658-6200","all codes distributed prior to and including 05/23/2013",".","3 units","The firm received seven reports of adverse reactions in the form of skin abscesses potentially linked to compounded preservative-free methylprednisolone 80mg/ml 10 ml vials. ",5/28/2013,"05/28/2013",12/11/2013,"12/11/2013"
"Drugs",65479,"Ongoing","Main Street Family Pharmacy, LLC","Newbern","TN","US","Voluntary: Firm Initiated","Telephone","nationwide, specifically: AK, AL, AZ, CA, CO, CT, DC, FL, GA, HI, IL, IN, KS, KY, LA, MA, MD, MN, MO, MS, NC, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, SC, TN, TX, UT, VA, WA, WI, and WV","D-145-2014","Class II","HCG 5,000U, Main Street Compounding Pharmacy, 126 East Main Street, Newbern, TN 38059, 888-658-6200","all codes distributed prior to and including 05/23/2013",".","2188 units","The firm received seven reports of adverse reactions in the form of skin abscesses potentially linked to compounded preservative-free methylprednisolone 80mg/ml 10 ml vials. ",5/28/2013,"05/28/2013",12/11/2013,"12/11/2013"
"Drugs",65479,"Ongoing","Main Street Family Pharmacy, LLC","Newbern","TN","US","Voluntary: Firm Initiated","Telephone","nationwide, specifically: AK, AL, AZ, CA, CO, CT, DC, FL, GA, HI, IL, IN, KS, KY, LA, MA, MD, MN, MO, MS, NC, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, SC, TN, TX, UT, VA, WA, WI, and WV","D-134-2014","Class II","HCG 320 iu prefilled syringes, Main Street Compounding Pharmacy, 126 East Main Street, Newbern, TN 38059, 888-658-6200","all codes distributed prior to and including 05/23/2013",".","7885 units","The firm received seven reports of adverse reactions in the form of skin abscesses potentially linked to compounded preservative-free methylprednisolone 80mg/ml 10 ml vials. ",5/28/2013,"05/28/2013",12/11/2013,"12/11/2013"
"Drugs",65479,"Ongoing","Main Street Family Pharmacy, LLC","Newbern","TN","US","Voluntary: Firm Initiated","Telephone","nationwide, specifically: AK, AL, AZ, CA, CO, CT, DC, FL, GA, HI, IL, IN, KS, KY, LA, MA, MD, MN, MO, MS, NC, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, SC, TN, TX, UT, VA, WA, WI, and WV","D-193-2014","Class II","Marcaine .1% NS 300ml pump, Main Street Compounding Pharmacy, 126 East Main Street, Newbern, TN 38059, 888-658-6200","all codes distributed prior to and including 05/23/2013",".","1 unit","The firm received seven reports of adverse reactions in the form of skin abscesses potentially linked to compounded preservative-free methylprednisolone 80mg/ml 10 ml vials. ",5/28/2013,"05/28/2013",12/11/2013,"12/11/2013"
"Drugs",65479,"Ongoing","Main Street Family Pharmacy, LLC","Newbern","TN","US","Voluntary: Firm Initiated","Telephone","nationwide, specifically: AK, AL, AZ, CA, CO, CT, DC, FL, GA, HI, IL, IN, KS, KY, LA, MA, MD, MN, MO, MS, NC, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, SC, TN, TX, UT, VA, WA, WI, and WV","D-066-2014","Class II","Calcium Gluconate 2.5% Gel, Main Street Compounding Pharmacy, 126 East Main Street, Newbern, TN 38059, 888-658-6200","all codes distributed prior to and including 05/23/2013",".","5 units","The firm received seven reports of adverse reactions in the form of skin abscesses potentially linked to compounded preservative-free methylprednisolone 80mg/ml 10 ml vials. ",5/28/2013,"05/28/2013",12/11/2013,"12/11/2013"
"Drugs",65479,"Ongoing","Main Street Family Pharmacy, LLC","Newbern","TN","US","Voluntary: Firm Initiated","Telephone","nationwide, specifically: AK, AL, AZ, CA, CO, CT, DC, FL, GA, HI, IL, IN, KS, KY, LA, MA, MD, MN, MO, MS, NC, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, SC, TN, TX, UT, VA, WA, WI, and WV","D-147-2014","Class II","HCG 5000iu kit, Main Street Compounding Pharmacy, 126 East Main Street, Newbern, TN 38059, 888-658-6200","all codes distributed prior to and including 05/23/2013",".","222 units","The firm received seven reports of adverse reactions in the form of skin abscesses potentially linked to compounded preservative-free methylprednisolone 80mg/ml 10 ml vials. ",5/28/2013,"05/28/2013",12/11/2013,"12/11/2013"
"Drugs",65479,"Ongoing","Main Street Family Pharmacy, LLC","Newbern","TN","US","Voluntary: Firm Initiated","Telephone","nationwide, specifically: AK, AL, AZ, CA, CO, CT, DC, FL, GA, HI, IL, IN, KS, KY, LA, MA, MD, MN, MO, MS, NC, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, SC, TN, TX, UT, VA, WA, WI, and WV","D-067-2014","Class II","Carnitine 250mg/ml, Main Street Compounding Pharmacy, 126 East Main Street, Newbern, TN 38059, 888-658-6200","all codes distributed prior to and including 05/23/2013",".","30 units","The firm received seven reports of adverse reactions in the form of skin abscesses potentially linked to compounded preservative-free methylprednisolone 80mg/ml 10 ml vials. ",5/28/2013,"05/28/2013",12/11/2013,"12/11/2013"
"Drugs",65479,"Ongoing","Main Street Family Pharmacy, LLC","Newbern","TN","US","Voluntary: Firm Initiated","Telephone","nationwide, specifically: AK, AL, AZ, CA, CO, CT, DC, FL, GA, HI, IL, IN, KS, KY, LA, MA, MD, MN, MO, MS, NC, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, SC, TN, TX, UT, VA, WA, WI, and WV","D-254-2014","Class II","Poison Ivy Extract 10ml, Main Street Compounding Pharmacy, 126 East Main Street, Newbern, TN 38059, 888-658-6200","all codes distributed prior to and including 05/23/2013",".","45 units","The firm received seven reports of adverse reactions in the form of skin abscesses potentially linked to compounded preservative-free methylprednisolone 80mg/ml 10 ml vials. ",5/28/2013,"05/28/2013",12/11/2013,"12/11/2013"
"Drugs",65479,"Ongoing","Main Street Family Pharmacy, LLC","Newbern","TN","US","Voluntary: Firm Initiated","Telephone","nationwide, specifically: AK, AL, AZ, CA, CO, CT, DC, FL, GA, HI, IL, IN, KS, KY, LA, MA, MD, MN, MO, MS, NC, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, SC, TN, TX, UT, VA, WA, WI, and WV","D-273-2014","Class II","Sodium Thiosulfate 25% 50ml, Main Street Compounding Pharmacy, 126 East Main Street, Newbern, TN 38059, 888-658-6200","all codes distributed prior to and including 05/23/2013",".","17 units","The firm received seven reports of adverse reactions in the form of skin abscesses potentially linked to compounded preservative-free methylprednisolone 80mg/ml 10 ml vials. ",5/28/2013,"05/28/2013",12/11/2013,"12/11/2013"
"Drugs",65479,"Ongoing","Main Street Family Pharmacy, LLC","Newbern","TN","US","Voluntary: Firm Initiated","Telephone","nationwide, specifically: AK, AL, AZ, CA, CO, CT, DC, FL, GA, HI, IL, IN, KS, KY, LA, MA, MD, MN, MO, MS, NC, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, SC, TN, TX, UT, VA, WA, WI, and WV","D-123-2014","Class II","HCG 240 iu prefilled syringes, Main Street Compounding Pharmacy, 126 East Main Street, Newbern, TN 38059, 888-658-6200","all codes distributed prior to and including 05/23/2013",".","1976 units","The firm received seven reports of adverse reactions in the form of skin abscesses potentially linked to compounded preservative-free methylprednisolone 80mg/ml 10 ml vials. ",5/28/2013,"05/28/2013",12/11/2013,"12/11/2013"
"Drugs",65479,"Ongoing","Main Street Family Pharmacy, LLC","Newbern","TN","US","Voluntary: Firm Initiated","Telephone","nationwide, specifically: AK, AL, AZ, CA, CO, CT, DC, FL, GA, HI, IL, IN, KS, KY, LA, MA, MD, MN, MO, MS, NC, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, SC, TN, TX, UT, VA, WA, WI, and WV","D-030-2014","Class II","Alphahydroxyprogesterone, 250mg, Main Street Compounding Pharmacy, 126 East Main Street, Newbern, TN 38059, 888-658-6200","all codes distributed prior to and including 05/23/2013",".","17 units","The firm received seven reports of adverse reactions in the form of skin abscesses potentially linked to compounded preservative-free methylprednisolone 80mg/ml 10 ml vials. ",5/28/2013,"05/28/2013",12/11/2013,"12/11/2013"
"Drugs",65479,"Ongoing","Main Street Family Pharmacy, LLC","Newbern","TN","US","Voluntary: Firm Initiated","Telephone","nationwide, specifically: AK, AL, AZ, CA, CO, CT, DC, FL, GA, HI, IL, IN, KS, KY, LA, MA, MD, MN, MO, MS, NC, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, SC, TN, TX, UT, VA, WA, WI, and WV","D-098-2014","Class II","Glutathione 150mg/ml 30ml, Main Street Compounding Pharmacy, 126 East Main Street, Newbern, TN 38059, 888-658-6200","all codes distributed prior to and including 05/23/2013",".","1 unit","The firm received seven reports of adverse reactions in the form of skin abscesses potentially linked to compounded preservative-free methylprednisolone 80mg/ml 10 ml vials. ",5/28/2013,"05/28/2013",12/11/2013,"12/11/2013"
"Drugs",65479,"Ongoing","Main Street Family Pharmacy, LLC","Newbern","TN","US","Voluntary: Firm Initiated","Telephone","nationwide, specifically: AK, AL, AZ, CA, CO, CT, DC, FL, GA, HI, IL, IN, KS, KY, LA, MA, MD, MN, MO, MS, NC, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, SC, TN, TX, UT, VA, WA, WI, and WV","D-314-2014","Class II","Triamcinolone 40mg PF 10ml, Main Street Compounding Pharmacy, 126 East Main Street, Newbern, TN 38059, 888-658-6200","all codes distributed prior to and including 05/23/2013",".","35 units","The firm received seven reports of adverse reactions in the form of skin abscesses potentially linked to compounded preservative-free methylprednisolone 80mg/ml 10 ml vials. ",5/28/2013,"05/28/2013",12/11/2013,"12/11/2013"
"Drugs",65479,"Ongoing","Main Street Family Pharmacy, LLC","Newbern","TN","US","Voluntary: Firm Initiated","Telephone","nationwide, specifically: AK, AL, AZ, CA, CO, CT, DC, FL, GA, HI, IL, IN, KS, KY, LA, MA, MD, MN, MO, MS, NC, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, SC, TN, TX, UT, VA, WA, WI, and WV","D-148-2014","Class II","HCG 500u/ml w/methylc. 1mg 10ml, Main Street Compounding Pharmacy, 126 East Main Street, Newbern, TN 38059, 888-658-6200","all codes distributed prior to and including 05/23/2013",".","1 unit","The firm received seven reports of adverse reactions in the form of skin abscesses potentially linked to compounded preservative-free methylprednisolone 80mg/ml 10 ml vials. ",5/28/2013,"05/28/2013",12/11/2013,"12/11/2013"
"Drugs",65479,"Ongoing","Main Street Family Pharmacy, LLC","Newbern","TN","US","Voluntary: Firm Initiated","Telephone","nationwide, specifically: AK, AL, AZ, CA, CO, CT, DC, FL, GA, HI, IL, IN, KS, KY, LA, MA, MD, MN, MO, MS, NC, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, SC, TN, TX, UT, VA, WA, WI, and WV","D-028-2014","Class II","Adenosine 35 mg/ml, 30ml, Main Street Compounding Pharmacy, 126 East Main Street, Newbern, TN 38059, 888-658-6200","all codes distributed prior to and including 05/23/2013",".","39 units","The firm received seven reports of adverse reactions in the form of skin abscesses potentially linked to compounded preservative-free methylprednisolone 80mg/ml 10 ml vials. ",5/28/2013,"05/28/2013",12/11/2013,"12/11/2013"
"Drugs",65479,"Ongoing","Main Street Family Pharmacy, LLC","Newbern","TN","US","Voluntary: Firm Initiated","Telephone","nationwide, specifically: AK, AL, AZ, CA, CO, CT, DC, FL, GA, HI, IL, IN, KS, KY, LA, MA, MD, MN, MO, MS, NC, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, SC, TN, TX, UT, VA, WA, WI, and WV","D-269-2014","Class II","Sodium Hyaluronate 6ml, Main Street Compounding Pharmacy, 126 East Main Street, Newbern, TN 38059, 888-658-6200","all codes distributed prior to and including 05/23/2013",".","24 units","The firm received seven reports of adverse reactions in the form of skin abscesses potentially linked to compounded preservative-free methylprednisolone 80mg/ml 10 ml vials. ",5/28/2013,"05/28/2013",12/11/2013,"12/11/2013"
"Drugs",65479,"Ongoing","Main Street Family Pharmacy, LLC","Newbern","TN","US","Voluntary: Firm Initiated","Telephone","nationwide, specifically: AK, AL, AZ, CA, CO, CT, DC, FL, GA, HI, IL, IN, KS, KY, LA, MA, MD, MN, MO, MS, NC, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, SC, TN, TX, UT, VA, WA, WI, and WV","D-058-2014","Class II","Betamethasone 6mg PF 10ml, Main Street Compounding Pharmacy, 126 East Main Street, Newbern, TN 38059, 888-658-6200","all codes distributed prior to and including 05/23/2013",".","2 units","The firm received seven reports of adverse reactions in the form of skin abscesses potentially linked to compounded preservative-free methylprednisolone 80mg/ml 10 ml vials. ",5/28/2013,"05/28/2013",12/11/2013,"12/11/2013"
"Drugs",65479,"Ongoing","Main Street Family Pharmacy, LLC","Newbern","TN","US","Voluntary: Firm Initiated","Telephone","nationwide, specifically: AK, AL, AZ, CA, CO, CT, DC, FL, GA, HI, IL, IN, KS, KY, LA, MA, MD, MN, MO, MS, NC, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, SC, TN, TX, UT, VA, WA, WI, and WV","D-135-2014","Class II","HCG 330 iu prefilled syringes, Main Street Compounding Pharmacy, 126 East Main Street, Newbern, TN 38059, 888-658-6200","all codes distributed prior to and including 05/23/2013",".","6643 units","The firm received seven reports of adverse reactions in the form of skin abscesses potentially linked to compounded preservative-free methylprednisolone 80mg/ml 10 ml vials. ",5/28/2013,"05/28/2013",12/11/2013,"12/11/2013"
"Drugs",65479,"Ongoing","Main Street Family Pharmacy, LLC","Newbern","TN","US","Voluntary: Firm Initiated","Telephone","nationwide, specifically: AK, AL, AZ, CA, CO, CT, DC, FL, GA, HI, IL, IN, KS, KY, LA, MA, MD, MN, MO, MS, NC, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, SC, TN, TX, UT, VA, WA, WI, and WV","D-178-2014","Class II","Lipotonix Plus w/Proc/Chrom, Main Street Compounding Pharmacy, 126 East Main Street, Newbern, TN 38059, 888-658-6200","all codes distributed prior to and including 05/23/2013",".","59 units","The firm received seven reports of adverse reactions in the form of skin abscesses potentially linked to compounded preservative-free methylprednisolone 80mg/ml 10 ml vials. ",5/28/2013,"05/28/2013",12/11/2013,"12/11/2013"
"Drugs",65479,"Ongoing","Main Street Family Pharmacy, LLC","Newbern","TN","US","Voluntary: Firm Initiated","Telephone","nationwide, specifically: AK, AL, AZ, CA, CO, CT, DC, FL, GA, HI, IL, IN, KS, KY, LA, MA, MD, MN, MO, MS, NC, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, SC, TN, TX, UT, VA, WA, WI, and WV","D-250-2014","Class II","Mitomycin C, Main Street Compounding Pharmacy, 126 East Main Street, Newbern, TN 38059, 888-658-6200","all codes distributed prior to and including 05/23/2013",".","12 units","The firm received seven reports of adverse reactions in the form of skin abscesses potentially linked to compounded preservative-free methylprednisolone 80mg/ml 10 ml vials. ",5/28/2013,"05/28/2013",12/11/2013,"12/11/2013"
"Drugs",65479,"Ongoing","Main Street Family Pharmacy, LLC","Newbern","TN","US","Voluntary: Firm Initiated","Telephone","nationwide, specifically: AK, AL, AZ, CA, CO, CT, DC, FL, GA, HI, IL, IN, KS, KY, LA, MA, MD, MN, MO, MS, NC, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, SC, TN, TX, UT, VA, WA, WI, and WV","D-197-2014","Class II","Marcaine .2%/NS 450ml, Main Street Compounding Pharmacy, 126 East Main Street, Newbern, TN 38059, 888-658-6200","all codes distributed prior to and including 05/23/2013",".","143 units","The firm received seven reports of adverse reactions in the form of skin abscesses potentially linked to compounded preservative-free methylprednisolone 80mg/ml 10 ml vials. ",5/28/2013,"05/28/2013",12/11/2013,"12/11/2013"
"Drugs",65479,"Ongoing","Main Street Family Pharmacy, LLC","Newbern","TN","US","Voluntary: Firm Initiated","Telephone","nationwide, specifically: AK, AL, AZ, CA, CO, CT, DC, FL, GA, HI, IL, IN, KS, KY, LA, MA, MD, MN, MO, MS, NC, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, SC, TN, TX, UT, VA, WA, WI, and WV","D-226-2014","Class II","Mic .05ml syrin, Main Street Compounding Pharmacy, 126 East Main Street, Newbern, TN 38059, 888-658-6200","all codes distributed prior to and including 05/23/2013",".","182 units","The firm received seven reports of adverse reactions in the form of skin abscesses potentially linked to compounded preservative-free methylprednisolone 80mg/ml 10 ml vials. ",5/28/2013,"05/28/2013",12/11/2013,"12/11/2013"
"Drugs",65479,"Ongoing","Main Street Family Pharmacy, LLC","Newbern","TN","US","Voluntary: Firm Initiated","Telephone","nationwide, specifically: AK, AL, AZ, CA, CO, CT, DC, FL, GA, HI, IL, IN, KS, KY, LA, MA, MD, MN, MO, MS, NC, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, SC, TN, TX, UT, VA, WA, WI, and WV","D-082-2014","Class II","Double Therapy Inj. SS ML, Main Street Compounding Pharmacy, 126 East Main Street, Newbern, TN 38059, 888-658-6200","all codes distributed prior to and including 05/23/2013",".","10 units","The firm received seven reports of adverse reactions in the form of skin abscesses potentially linked to compounded preservative-free methylprednisolone 80mg/ml 10 ml vials. ",5/28/2013,"05/28/2013",12/11/2013,"12/11/2013"
"Drugs",65479,"Ongoing","Main Street Family Pharmacy, LLC","Newbern","TN","US","Voluntary: Firm Initiated","Telephone","nationwide, specifically: AK, AL, AZ, CA, CO, CT, DC, FL, GA, HI, IL, IN, KS, KY, LA, MA, MD, MN, MO, MS, NC, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, SC, TN, TX, UT, VA, WA, WI, and WV","D-085-2014","Class II","Estradiol Valerate 40mg, Main Street Compounding Pharmacy, 126 East Main Street, Newbern, TN 38059, 888-658-6200","all codes distributed prior to and including 05/23/2013",".","62 units","The firm received seven reports of adverse reactions in the form of skin abscesses potentially linked to compounded preservative-free methylprednisolone 80mg/ml 10 ml vials. ",5/28/2013,"05/28/2013",12/11/2013,"12/11/2013"
"Drugs",65479,"Ongoing","Main Street Family Pharmacy, LLC","Newbern","TN","US","Voluntary: Firm Initiated","Telephone","nationwide, specifically: AK, AL, AZ, CA, CO, CT, DC, FL, GA, HI, IL, IN, KS, KY, LA, MA, MD, MN, MO, MS, NC, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, SC, TN, TX, UT, VA, WA, WI, and WV","D-194-2014","Class II","Marcaine .1%/NS 400ml-pump, Main Street Compounding Pharmacy, 126 East Main Street, Newbern, TN 38059, 888-658-6200","all codes distributed prior to and including 05/23/2013",".","2 units","The firm received seven reports of adverse reactions in the form of skin abscesses potentially linked to compounded preservative-free methylprednisolone 80mg/ml 10 ml vials. ",5/28/2013,"05/28/2013",12/11/2013,"12/11/2013"
"Drugs",65479,"Ongoing","Main Street Family Pharmacy, LLC","Newbern","TN","US","Voluntary: Firm Initiated","Telephone","nationwide, specifically: AK, AL, AZ, CA, CO, CT, DC, FL, GA, HI, IL, IN, KS, KY, LA, MA, MD, MN, MO, MS, NC, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, SC, TN, TX, UT, VA, WA, WI, and WV","D-072-2014","Class II","Dexamethasone LA 16mg/ml 30ml, Main Street Compounding Pharmacy, 126 East Main Street, Newbern, TN 38059, 888-658-6200","all codes distributed prior to and including 05/23/2013",".","54 units","The firm received seven reports of adverse reactions in the form of skin abscesses potentially linked to compounded preservative-free methylprednisolone 80mg/ml 10 ml vials. ",5/28/2013,"05/28/2013",12/11/2013,"12/11/2013"
"Drugs",65479,"Ongoing","Main Street Family Pharmacy, LLC","Newbern","TN","US","Voluntary: Firm Initiated","Telephone","nationwide, specifically: AK, AL, AZ, CA, CO, CT, DC, FL, GA, HI, IL, IN, KS, KY, LA, MA, MD, MN, MO, MS, NC, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, SC, TN, TX, UT, VA, WA, WI, and WV","D-169-2014","Class II","Lipo B Complex 30ml, Main Street Compounding Pharmacy, 126 East Main Street, Newbern, TN 38059, 888-658-6200","all codes distributed prior to and including 05/23/2013",".","20 units","The firm received seven reports of adverse reactions in the form of skin abscesses potentially linked to compounded preservative-free methylprednisolone 80mg/ml 10 ml vials. ",5/28/2013,"05/28/2013",12/11/2013,"12/11/2013"
"Drugs",65479,"Ongoing","Main Street Family Pharmacy, LLC","Newbern","TN","US","Voluntary: Firm Initiated","Telephone","nationwide, specifically: AK, AL, AZ, CA, CO, CT, DC, FL, GA, HI, IL, IN, KS, KY, LA, MA, MD, MN, MO, MS, NC, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, SC, TN, TX, UT, VA, WA, WI, and WV","D-256-2014","Class II","Post-menopausal HCG pack, Main Street Compounding Pharmacy, 126 East Main Street, Newbern, TN 38059, 888-658-6200","all codes distributed prior to and including 05/23/2013",".","489 units","The firm received seven reports of adverse reactions in the form of skin abscesses potentially linked to compounded preservative-free methylprednisolone 80mg/ml 10 ml vials. ",5/28/2013,"05/28/2013",12/11/2013,"12/11/2013"
"Drugs",65479,"Ongoing","Main Street Family Pharmacy, LLC","Newbern","TN","US","Voluntary: Firm Initiated","Telephone","nationwide, specifically: AK, AL, AZ, CA, CO, CT, DC, FL, GA, HI, IL, IN, KS, KY, LA, MA, MD, MN, MO, MS, NC, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, SC, TN, TX, UT, VA, WA, WI, and WV","D-125-2014","Class II","HCG 2500u, Main Street Compounding Pharmacy, 126 East Main Street, Newbern, TN 38059, 888-658-6200","all codes distributed prior to and including 05/23/2013",".","41 units","The firm received seven reports of adverse reactions in the form of skin abscesses potentially linked to compounded preservative-free methylprednisolone 80mg/ml 10 ml vials. ",5/28/2013,"05/28/2013",12/11/2013,"12/11/2013"
"Drugs",65479,"Ongoing","Main Street Family Pharmacy, LLC","Newbern","TN","US","Voluntary: Firm Initiated","Telephone","nationwide, specifically: AK, AL, AZ, CA, CO, CT, DC, FL, GA, HI, IL, IN, KS, KY, LA, MA, MD, MN, MO, MS, NC, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, SC, TN, TX, UT, VA, WA, WI, and WV","D-289-2014","Class II","Testosterone Cypionate 250mg 10ml, Main Street Compounding Pharmacy, 126 East Main Street, Newbern, TN 38059, 888-658-6200","distributed prior to and including 05/23/2013",".","21 units","The firm received seven reports of adverse reactions in the form of skin abscesses potentially linked to compounded preservative-free methylprednisolone 80mg/ml 10 ml vials. ",5/28/2013,"05/28/2013",12/11/2013,"12/11/2013"
"Drugs",65479,"Ongoing","Main Street Family Pharmacy, LLC","Newbern","TN","US","Voluntary: Firm Initiated","Telephone","nationwide, specifically: AK, AL, AZ, CA, CO, CT, DC, FL, GA, HI, IL, IN, KS, KY, LA, MA, MD, MN, MO, MS, NC, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, SC, TN, TX, UT, VA, WA, WI, and WV","D-086-2014","Class II","Estradiol Pellet 20mg, Main Street Compounding Pharmacy, 126 East Main Street, Newbern, TN 38059, 888-658-6200","all codes distributed prior to and including 05/23/2013",".","52 units","The firm received seven reports of adverse reactions in the form of skin abscesses potentially linked to compounded preservative-free methylprednisolone 80mg/ml 10 ml vials. ",5/28/2013,"05/28/2013",12/11/2013,"12/11/2013"
"Drugs",65479,"Ongoing","Main Street Family Pharmacy, LLC","Newbern","TN","US","Voluntary: Firm Initiated","Telephone","nationwide, specifically: AK, AL, AZ, CA, CO, CT, DC, FL, GA, HI, IL, IN, KS, KY, LA, MA, MD, MN, MO, MS, NC, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, SC, TN, TX, UT, VA, WA, WI, and WV","D-316-2014","Class II","Triamcinolone 40mg PF 10ml, Main Street Compounding Pharmacy, 126 East Main Street, Newbern, TN 38059, 888-658-6200","all codes distributed prior to and including 05/23/2013",".","2164 units","The firm received seven reports of adverse reactions in the form of skin abscesses potentially linked to compounded preservative-free methylprednisolone 80mg/ml 10 ml vials. ",5/28/2013,"05/28/2013",12/11/2013,"12/11/2013"
"Drugs",65479,"Ongoing","Main Street Family Pharmacy, LLC","Newbern","TN","US","Voluntary: Firm Initiated","Telephone","nationwide, specifically: AK, AL, AZ, CA, CO, CT, DC, FL, GA, HI, IL, IN, KS, KY, LA, MA, MD, MN, MO, MS, NC, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, SC, TN, TX, UT, VA, WA, WI, and WV","D-242-2014","Class II","Mic w/B6/B12/Lido 50ml, Main Street Compounding Pharmacy, 126 East Main Street, Newbern, TN 38059, 888-658-6200","all codes distributed prior to and including 05/23/2013",".","95 units","The firm received seven reports of adverse reactions in the form of skin abscesses potentially linked to compounded preservative-free methylprednisolone 80mg/ml 10 ml vials. ",5/28/2013,"05/28/2013",12/11/2013,"12/11/2013"
"Drugs",65479,"Ongoing","Main Street Family Pharmacy, LLC","Newbern","TN","US","Voluntary: Firm Initiated","Telephone","nationwide, specifically: AK, AL, AZ, CA, CO, CT, DC, FL, GA, HI, IL, IN, KS, KY, LA, MA, MD, MN, MO, MS, NC, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, SC, TN, TX, UT, VA, WA, WI, and WV","D-118-2014","Class II","HCG 2000iu PFS, Main Street Compounding Pharmacy, 126 East Main Street, Newbern, TN 38059, 888-658-6200","all codes distributed prior to and including 05/23/2013",".","6 units","The firm received seven reports of adverse reactions in the form of skin abscesses potentially linked to compounded preservative-free methylprednisolone 80mg/ml 10 ml vials. ",5/28/2013,"05/28/2013",12/11/2013,"12/11/2013"
"Drugs",65479,"Ongoing","Main Street Family Pharmacy, LLC","Newbern","TN","US","Voluntary: Firm Initiated","Telephone","nationwide, specifically: AK, AL, AZ, CA, CO, CT, DC, FL, GA, HI, IL, IN, KS, KY, LA, MA, MD, MN, MO, MS, NC, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, SC, TN, TX, UT, VA, WA, WI, and WV","D-120-2014","Class II","HCG 220 iu prefilled syringes, Main Street Compounding Pharmacy, 126 East Main Street, Newbern, TN 38059, 888-658-6200","all codes distributed prior to and including 05/23/2013",".","1881 units","The firm received seven reports of adverse reactions in the form of skin abscesses potentially linked to compounded preservative-free methylprednisolone 80mg/ml 10 ml vials. ",5/28/2013,"05/28/2013",12/11/2013,"12/11/2013"
"Drugs",65479,"Ongoing","Main Street Family Pharmacy, LLC","Newbern","TN","US","Voluntary: Firm Initiated","Telephone","nationwide, specifically: AK, AL, AZ, CA, CO, CT, DC, FL, GA, HI, IL, IN, KS, KY, LA, MA, MD, MN, MO, MS, NC, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, SC, TN, TX, UT, VA, WA, WI, and WV","D-032-2014","Class II","Alprostadil 20mcg/ml 25ml, Main Street Compounding Pharmacy, 126 East Main Street, Newbern, TN 38059, 888-658-6200","all codes distributed prior to and including 05/23/2013",".","4 units","The firm received seven reports of adverse reactions in the form of skin abscesses potentially linked to compounded preservative-free methylprednisolone 80mg/ml 10 ml vials. ",5/28/2013,"05/28/2013",12/11/2013,"12/11/2013"
"Drugs",65479,"Ongoing","Main Street Family Pharmacy, LLC","Newbern","TN","US","Voluntary: Firm Initiated","Telephone","nationwide, specifically: AK, AL, AZ, CA, CO, CT, DC, FL, GA, HI, IL, IN, KS, KY, LA, MA, MD, MN, MO, MS, NC, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, SC, TN, TX, UT, VA, WA, WI, and WV","D-109-2014","Class II","HCG 140 iu prefilled syringes, Main Street Compounding Pharmacy, 126 East Main Street, Newbern, TN 38059, 888-658-6200","all codes distributed prior to and including 05/23/2013",".","3 units","The firm received seven reports of adverse reactions in the form of skin abscesses potentially linked to compounded preservative-free methylprednisolone 80mg/ml 10 ml vials. ",5/28/2013,"05/28/2013",12/11/2013,"12/11/2013"
"Drugs",65479,"Ongoing","Main Street Family Pharmacy, LLC","Newbern","TN","US","Voluntary: Firm Initiated","Telephone","nationwide, specifically: AK, AL, AZ, CA, CO, CT, DC, FL, GA, HI, IL, IN, KS, KY, LA, MA, MD, MN, MO, MS, NC, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, SC, TN, TX, UT, VA, WA, WI, and WV","D-198-2014","Class II","Medroxyprogesterone 150mg PF 1ml, Main Street Compounding Pharmacy, 126 East Main Street, Newbern, TN 38059, 888-658-6200","all codes distributed prior to and including 05/23/2013",".","2 units","The firm received seven reports of adverse reactions in the form of skin abscesses potentially linked to compounded preservative-free methylprednisolone 80mg/ml 10 ml vials. ",5/28/2013,"05/28/2013",12/11/2013,"12/11/2013"
"Drugs",65479,"Ongoing","Main Street Family Pharmacy, LLC","Newbern","TN","US","Voluntary: Firm Initiated","Telephone","nationwide, specifically: AK, AL, AZ, CA, CO, CT, DC, FL, GA, HI, IL, IN, KS, KY, LA, MA, MD, MN, MO, MS, NC, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, SC, TN, TX, UT, VA, WA, WI, and WV","D-214-2014","Class II","Methylprednisolone 40mg 10ml, Main Street Compounding Pharmacy, 126 East Main Street, Newbern, TN 38059, 888-658-6200","all codes distributed prior to and including 05/23/2013",".","166 units","The firm received seven reports of adverse reactions in the form of skin abscesses potentially linked to compounded preservative-free methylprednisolone 80mg/ml 10 ml vials. ",5/28/2013,"05/28/2013",12/11/2013,"12/11/2013"
"Drugs",65479,"Ongoing","Main Street Family Pharmacy, LLC","Newbern","TN","US","Voluntary: Firm Initiated","Telephone","nationwide, specifically: AK, AL, AZ, CA, CO, CT, DC, FL, GA, HI, IL, IN, KS, KY, LA, MA, MD, MN, MO, MS, NC, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, SC, TN, TX, UT, VA, WA, WI, and WV","D-114-2014","Class II","HCG 180 iu prefilled syringes, Main Street Compounding Pharmacy, 126 East Main Street, Newbern, TN 38059, 888-658-6200","all codes distributed prior to and including 05/23/2013",".","3 units","The firm received seven reports of adverse reactions in the form of skin abscesses potentially linked to compounded preservative-free methylprednisolone 80mg/ml 10 ml vials. ",5/28/2013,"05/28/2013",12/11/2013,"12/11/2013"
"Drugs",65479,"Ongoing","Main Street Family Pharmacy, LLC","Newbern","TN","US","Voluntary: Firm Initiated","Telephone","nationwide, specifically: AK, AL, AZ, CA, CO, CT, DC, FL, GA, HI, IL, IN, KS, KY, LA, MA, MD, MN, MO, MS, NC, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, SC, TN, TX, UT, VA, WA, WI, and WV","D-248-2014","Class II","Mitomycin 40mg, Main Street Compounding Pharmacy, 126 East Main Street, Newbern, TN 38059, 888-658-6200","all codes distributed prior to and including 05/23/2013",".","370 units","The firm received seven reports of adverse reactions in the form of skin abscesses potentially linked to compounded preservative-free methylprednisolone 80mg/ml 10 ml vials. ",5/28/2013,"05/28/2013",12/11/2013,"12/11/2013"
"Drugs",65479,"Ongoing","Main Street Family Pharmacy, LLC","Newbern","TN","US","Voluntary: Firm Initiated","Telephone","nationwide, specifically: AK, AL, AZ, CA, CO, CT, DC, FL, GA, HI, IL, IN, KS, KY, LA, MA, MD, MN, MO, MS, NC, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, SC, TN, TX, UT, VA, WA, WI, and WV","D-221-2014","Class II","Methylprednisolone 80mg SDV, 10ml Main Street Compounding Pharmacy, 126 East Main Street, Newbern, TN 38059, 888-658-6200","all codes distributed prior to and including 05/23/2013",".","10 units","The firm received seven reports of adverse reactions in the form of skin abscesses potentially linked to compounded preservative-free methylprednisolone 80mg/ml 10 ml vials. ",5/28/2013,"05/28/2013",12/11/2013,"12/11/2013"
"Drugs",65479,"Ongoing","Main Street Family Pharmacy, LLC","Newbern","TN","US","Voluntary: Firm Initiated","Telephone","nationwide, specifically: AK, AL, AZ, CA, CO, CT, DC, FL, GA, HI, IL, IN, KS, KY, LA, MA, MD, MN, MO, MS, NC, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, SC, TN, TX, UT, VA, WA, WI, and WV","D-257-2014","Class II","Post-menopausal HCG Pk 2nd mont, Main Street Compounding Pharmacy, 126 East Main Street, Newbern, TN 38059, 888-658-6200","all codes distributed prior to and including 05/23/2013",".","80 units","The firm received seven reports of adverse reactions in the form of skin abscesses potentially linked to compounded preservative-free methylprednisolone 80mg/ml 10 ml vials. ",5/28/2013,"05/28/2013",12/11/2013,"12/11/2013"
"Drugs",65479,"Ongoing","Main Street Family Pharmacy, LLC","Newbern","TN","US","Voluntary: Firm Initiated","Telephone","nationwide, specifically: AK, AL, AZ, CA, CO, CT, DC, FL, GA, HI, IL, IN, KS, KY, LA, MA, MD, MN, MO, MS, NC, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, SC, TN, TX, UT, VA, WA, WI, and WV","D-157-2014","Class II","L-glutamine 30mg/ml 30ml vial, Main Street Compounding Pharmacy, 126 East Main Street, Newbern, TN 38059, 888-658-6200","all codes distributed prior to and including 05/23/2013",".","1 unit","The firm received seven reports of adverse reactions in the form of skin abscesses potentially linked to compounded preservative-free methylprednisolone 80mg/ml 10 ml vials. ",5/28/2013,"05/28/2013",12/11/2013,"12/11/2013"
"Drugs",65479,"Ongoing","Main Street Family Pharmacy, LLC","Newbern","TN","US","Voluntary: Firm Initiated","Telephone","nationwide, specifically: AK, AL, AZ, CA, CO, CT, DC, FL, GA, HI, IL, IN, KS, KY, LA, MA, MD, MN, MO, MS, NC, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, SC, TN, TX, UT, VA, WA, WI, and WV","D-132-2014","Class II","HCG 3000IU, Main Street Compounding Pharmacy, 126 East Main Street, Newbern, TN 38059, 888-658-6200","all codes distributed prior to and including 05/23/2013",".","10 units","The firm received seven reports of adverse reactions in the form of skin abscesses potentially linked to compounded preservative-free methylprednisolone 80mg/ml 10 ml vials. ",5/28/2013,"05/28/2013",12/11/2013,"12/11/2013"
"Drugs",65479,"Ongoing","Main Street Family Pharmacy, LLC","Newbern","TN","US","Voluntary: Firm Initiated","Telephone","nationwide, specifically: AK, AL, AZ, CA, CO, CT, DC, FL, GA, HI, IL, IN, KS, KY, LA, MA, MD, MN, MO, MS, NC, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, SC, TN, TX, UT, VA, WA, WI, and WV","D-208-2014","Class II","Methylcobalamin 1mg/ml 30ml, Main Street Compounding Pharmacy, 126 East Main Street, Newbern, TN 38059, 888-658-6200","all codes distributed prior to and including 05/23/2013",".","24 units","The firm received seven reports of adverse reactions in the form of skin abscesses potentially linked to compounded preservative-free methylprednisolone 80mg/ml 10 ml vials. ",5/28/2013,"05/28/2013",12/11/2013,"12/11/2013"
"Drugs",65479,"Ongoing","Main Street Family Pharmacy, LLC","Newbern","TN","US","Voluntary: Firm Initiated","Telephone","nationwide, specifically: AK, AL, AZ, CA, CO, CT, DC, FL, GA, HI, IL, IN, KS, KY, LA, MA, MD, MN, MO, MS, NC, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, SC, TN, TX, UT, VA, WA, WI, and WV","D-101-2014","Class II","Glycolic 70% ph 1.8 - gel 60ml, Main Street Compounding Pharmacy, 126 East Main Street, Newbern, TN 38059, 888-658-6200","all codes distributed prior to and including 05/23/2013",".","1 unit","The firm received seven reports of adverse reactions in the form of skin abscesses potentially linked to compounded preservative-free methylprednisolone 80mg/ml 10 ml vials. ",5/28/2013,"05/28/2013",12/11/2013,"12/11/2013"
"Drugs",65479,"Ongoing","Main Street Family Pharmacy, LLC","Newbern","TN","US","Voluntary: Firm Initiated","Telephone","nationwide, specifically: AK, AL, AZ, CA, CO, CT, DC, FL, GA, HI, IL, IN, KS, KY, LA, MA, MD, MN, MO, MS, NC, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, SC, TN, TX, UT, VA, WA, WI, and WV","D-049-2014","Class II","Bacteriostatic Water 30ml, Main Street Compounding Pharmacy, 126 East Main Street, Newbern, TN 38059, 888-658-6200","all codes distributed prior to and including 05/23/2013",".","2462 units","The firm received seven reports of adverse reactions in the form of skin abscesses potentially linked to compounded preservative-free methylprednisolone 80mg/ml 10 ml vials. ",5/28/2013,"05/28/2013",12/11/2013,"12/11/2013"
"Drugs",65479,"Ongoing","Main Street Family Pharmacy, LLC","Newbern","TN","US","Voluntary: Firm Initiated","Telephone","nationwide, specifically: AK, AL, AZ, CA, CO, CT, DC, FL, GA, HI, IL, IN, KS, KY, LA, MA, MD, MN, MO, MS, NC, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, SC, TN, TX, UT, VA, WA, WI, and WV","D-097-2014","Class II","Glutathione ''Reduced'' 200mg/ml, Main Street Compounding Pharmacy, 126 East Main Street, Newbern, TN 38059, 888-658-6200","all codes distributed prior to and including 05/23/2013",".","19 units","The firm received seven reports of adverse reactions in the form of skin abscesses potentially linked to compounded preservative-free methylprednisolone 80mg/ml 10 ml vials. ",5/28/2013,"05/28/2013",12/11/2013,"12/11/2013"
"Drugs",65479,"Ongoing","Main Street Family Pharmacy, LLC","Newbern","TN","US","Voluntary: Firm Initiated","Telephone","nationwide, specifically: AK, AL, AZ, CA, CO, CT, DC, FL, GA, HI, IL, IN, KS, KY, LA, MA, MD, MN, MO, MS, NC, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, SC, TN, TX, UT, VA, WA, WI, and WV","D-057-2014","Class II","Betamethasone 6mg 30ml, Main Street Compounding Pharmacy, 126 East Main Street, Newbern, TN 38059, 888-658-6200","all codes distributed prior to and including 05/23/2013",".","383 units","The firm received seven reports of adverse reactions in the form of skin abscesses potentially linked to compounded preservative-free methylprednisolone 80mg/ml 10 ml vials. ",5/28/2013,"05/28/2013",12/11/2013,"12/11/2013"
"Drugs",65479,"Ongoing","Main Street Family Pharmacy, LLC","Newbern","TN","US","Voluntary: Firm Initiated","Telephone","nationwide, specifically: AK, AL, AZ, CA, CO, CT, DC, FL, GA, HI, IL, IN, KS, KY, LA, MA, MD, MN, MO, MS, NC, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, SC, TN, TX, UT, VA, WA, WI, and WV","D-099-2014","Class II","Glycerin 72% 30ml, Main Street Compounding Pharmacy, 126 East Main Street, Newbern, TN 38059, 888-658-6200","all codes distributed prior to and including 05/23/2013",".","11 units","The firm received seven reports of adverse reactions in the form of skin abscesses potentially linked to compounded preservative-free methylprednisolone 80mg/ml 10 ml vials. ",5/28/2013,"05/28/2013",12/11/2013,"12/11/2013"
"Drugs",65479,"Ongoing","Main Street Family Pharmacy, LLC","Newbern","TN","US","Voluntary: Firm Initiated","Telephone","nationwide, specifically: AK, AL, AZ, CA, CO, CT, DC, FL, GA, HI, IL, IN, KS, KY, LA, MA, MD, MN, MO, MS, NC, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, SC, TN, TX, UT, VA, WA, WI, and WV","D-235-2014","Class II","Mic Ultra 10ml, Main Street Compounding Pharmacy, 126 East Main Street, Newbern, TN 38059, 888-658-6200","all codes distributed prior to and including 05/23/2013",".","76 units","The firm received seven reports of adverse reactions in the form of skin abscesses potentially linked to compounded preservative-free methylprednisolone 80mg/ml 10 ml vials. ",5/28/2013,"05/28/2013",12/11/2013,"12/11/2013"
"Drugs",65479,"Ongoing","Main Street Family Pharmacy, LLC","Newbern","TN","US","Voluntary: Firm Initiated","Telephone","nationwide, specifically: AK, AL, AZ, CA, CO, CT, DC, FL, GA, HI, IL, IN, KS, KY, LA, MA, MD, MN, MO, MS, NC, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, SC, TN, TX, UT, VA, WA, WI, and WV","D-131-2014","Class II","HCG 300 iu prefilled syringes, Main Street Compounding Pharmacy, 126 East Main Street, Newbern, TN 38059, 888-658-6200","all codes distributed prior to and including 05/23/2013",".","5349 units","The firm received seven reports of adverse reactions in the form of skin abscesses potentially linked to compounded preservative-free methylprednisolone 80mg/ml 10 ml vials. ",5/28/2013,"05/28/2013",12/11/2013,"12/11/2013"
"Drugs",65479,"Ongoing","Main Street Family Pharmacy, LLC","Newbern","TN","US","Voluntary: Firm Initiated","Telephone","nationwide, specifically: AK, AL, AZ, CA, CO, CT, DC, FL, GA, HI, IL, IN, KS, KY, LA, MA, MD, MN, MO, MS, NC, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, SC, TN, TX, UT, VA, WA, WI, and WV","D-150-2014","Class II","HCG 7000u, Main Street Compounding Pharmacy, 126 East Main Street, Newbern, TN 38059, 888-658-6200","all codes distributed prior to and including 05/23/2013",".","2 units","The firm received seven reports of adverse reactions in the form of skin abscesses potentially linked to compounded preservative-free methylprednisolone 80mg/ml 10 ml vials. ",5/28/2013,"05/28/2013",12/11/2013,"12/11/2013"
"Drugs",65479,"Ongoing","Main Street Family Pharmacy, LLC","Newbern","TN","US","Voluntary: Firm Initiated","Telephone","nationwide, specifically: AK, AL, AZ, CA, CO, CT, DC, FL, GA, HI, IL, IN, KS, KY, LA, MA, MD, MN, MO, MS, NC, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, SC, TN, TX, UT, VA, WA, WI, and WV","D-258-2014","Class II","Post-menopausal HCG Pk 3rd mont, Main Street Compounding Pharmacy, 126 East Main Street, Newbern, TN 38059, 888-658-6200","all codes distributed prior to and including 05/23/2013",".","39 units","The firm received seven reports of adverse reactions in the form of skin abscesses potentially linked to compounded preservative-free methylprednisolone 80mg/ml 10 ml vials. ",5/28/2013,"05/28/2013",12/11/2013,"12/11/2013"
"Drugs",65479,"Ongoing","Main Street Family Pharmacy, LLC","Newbern","TN","US","Voluntary: Firm Initiated","Telephone","nationwide, specifically: AK, AL, AZ, CA, CO, CT, DC, FL, GA, HI, IL, IN, KS, KY, LA, MA, MD, MN, MO, MS, NC, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, SC, TN, TX, UT, VA, WA, WI, and WV","D-322-2014","Class II","Wydase 5ml, Main Street Compounding Pharmacy, 126 East Main Street, Newbern, TN 38059, 888-658-6200","all codes distributed prior to and including 05/23/2013",".","50 units","The firm received seven reports of adverse reactions in the form of skin abscesses potentially linked to compounded preservative-free methylprednisolone 80mg/ml 10 ml vials. ",5/28/2013,"05/28/2013",12/11/2013,"12/11/2013"
"Drugs",65479,"Ongoing","Main Street Family Pharmacy, LLC","Newbern","TN","US","Voluntary: Firm Initiated","Telephone","nationwide, specifically: AK, AL, AZ, CA, CO, CT, DC, FL, GA, HI, IL, IN, KS, KY, LA, MA, MD, MN, MO, MS, NC, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, SC, TN, TX, UT, VA, WA, WI, and WV","D-290-2014","Class II","Testosterone Cypionate w/lidocaine 10ml, Main Street Compounding Pharmacy, 126 East Main Street, Newbern, TN 38059, 888-658-6200","distributed prior to and including 05/23/2013",".","20 units","The firm received seven reports of adverse reactions in the form of skin abscesses potentially linked to compounded preservative-free methylprednisolone 80mg/ml 10 ml vials. ",5/28/2013,"05/28/2013",12/11/2013,"12/11/2013"
"Drugs",65479,"Ongoing","Main Street Family Pharmacy, LLC","Newbern","TN","US","Voluntary: Firm Initiated","Telephone","nationwide, specifically: AK, AL, AZ, CA, CO, CT, DC, FL, GA, HI, IL, IN, KS, KY, LA, MA, MD, MN, MO, MS, NC, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, SC, TN, TX, UT, VA, WA, WI, and WV","D-271-2014","Class II","Sodium Tetradecyl Sulfate 3.0%, 30ml Main Street Compounding Pharmacy, 126 East Main Street, Newbern, TN 38059, 888-658-6200","all codes distributed prior to and including 05/23/2013",".","1 unit","The firm received seven reports of adverse reactions in the form of skin abscesses potentially linked to compounded preservative-free methylprednisolone 80mg/ml 10 ml vials. ",5/28/2013,"05/28/2013",12/11/2013,"12/11/2013"
"Drugs",65479,"Ongoing","Main Street Family Pharmacy, LLC","Newbern","TN","US","Voluntary: Firm Initiated","Telephone","nationwide, specifically: AK, AL, AZ, CA, CO, CT, DC, FL, GA, HI, IL, IN, KS, KY, LA, MA, MD, MN, MO, MS, NC, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, SC, TN, TX, UT, VA, WA, WI, and WV","D-045-2014","Class II","B-12 1ml prefilled syringe, Main Street Compounding Pharmacy, 126 East Main Street, Newbern, TN 38059, 888-658-6200","all codes distributed prior to and including 05/23/2013",".","15 units","The firm received seven reports of adverse reactions in the form of skin abscesses potentially linked to compounded preservative-free methylprednisolone 80mg/ml 10 ml vials. ",5/28/2013,"05/28/2013",12/11/2013,"12/11/2013"
"Drugs",65479,"Ongoing","Main Street Family Pharmacy, LLC","Newbern","TN","US","Voluntary: Firm Initiated","Telephone","nationwide, specifically: AK, AL, AZ, CA, CO, CT, DC, FL, GA, HI, IL, IN, KS, KY, LA, MA, MD, MN, MO, MS, NC, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, SC, TN, TX, UT, VA, WA, WI, and WV","D-115-2014","Class II","HCG 20,000u, Main Street Compounding Pharmacy, 126 East Main Street, Newbern, TN 38059, 888-658-6200","all codes distributed prior to and including 05/23/2013",".","531 units","The firm received seven reports of adverse reactions in the form of skin abscesses potentially linked to compounded preservative-free methylprednisolone 80mg/ml 10 ml vials. ",5/28/2013,"05/28/2013",12/11/2013,"12/11/2013"
"Drugs",65479,"Ongoing","Main Street Family Pharmacy, LLC","Newbern","TN","US","Voluntary: Firm Initiated","Telephone","nationwide, specifically: AK, AL, AZ, CA, CO, CT, DC, FL, GA, HI, IL, IN, KS, KY, LA, MA, MD, MN, MO, MS, NC, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, SC, TN, TX, UT, VA, WA, WI, and WV","D-033-2014","Class II","Alprostadil 40mg, Main Street Compounding Pharmacy, 126 East Main Street, Newbern, TN 38059, 888-658-6200","all codes distributed prior to and including 05/23/2013",".","1 unit","The firm received seven reports of adverse reactions in the form of skin abscesses potentially linked to compounded preservative-free methylprednisolone 80mg/ml 10 ml vials. ",5/28/2013,"05/28/2013",12/11/2013,"12/11/2013"
"Drugs",65479,"Ongoing","Main Street Family Pharmacy, LLC","Newbern","TN","US","Voluntary: Firm Initiated","Telephone","nationwide, specifically: AK, AL, AZ, CA, CO, CT, DC, FL, GA, HI, IL, IN, KS, KY, LA, MA, MD, MN, MO, MS, NC, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, SC, TN, TX, UT, VA, WA, WI, and WV","D-175-2014","Class II","Lipotonix Plus 10ml, Main Street Compounding Pharmacy, 126 East Main Street, Newbern, TN 38059, 888-658-6200","all codes distributed prior to and including 05/23/2013",".","720 units","The firm received seven reports of adverse reactions in the form of skin abscesses potentially linked to compounded preservative-free methylprednisolone 80mg/ml 10 ml vials. ",5/28/2013,"05/28/2013",12/11/2013,"12/11/2013"
"Drugs",65479,"Ongoing","Main Street Family Pharmacy, LLC","Newbern","TN","US","Voluntary: Firm Initiated","Telephone","nationwide, specifically: AK, AL, AZ, CA, CO, CT, DC, FL, GA, HI, IL, IN, KS, KY, LA, MA, MD, MN, MO, MS, NC, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, SC, TN, TX, UT, VA, WA, WI, and WV","D-209-2014","Class II","Methylcobalamin 30ml, Main Street Compounding Pharmacy, 126 East Main Street, Newbern, TN 38059, 888-658-6200","all codes distributed prior to and including 05/23/2013",".","5 units","The firm received seven reports of adverse reactions in the form of skin abscesses potentially linked to compounded preservative-free methylprednisolone 80mg/ml 10 ml vials. ",5/28/2013,"05/28/2013",12/11/2013,"12/11/2013"
"Drugs",65479,"Ongoing","Main Street Family Pharmacy, LLC","Newbern","TN","US","Voluntary: Firm Initiated","Telephone","nationwide, specifically: AK, AL, AZ, CA, CO, CT, DC, FL, GA, HI, IL, IN, KS, KY, LA, MA, MD, MN, MO, MS, NC, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, SC, TN, TX, UT, VA, WA, WI, and WV","D-159-2014","Class II","Lido 2% MPF 2ml, Main Street Compounding Pharmacy, 126 East Main Street, Newbern, TN 38059, 888-658-6200","all codes distributed prior to and including 05/23/2013",".","945 units","The firm received seven reports of adverse reactions in the form of skin abscesses potentially linked to compounded preservative-free methylprednisolone 80mg/ml 10 ml vials. ",5/28/2013,"05/28/2013",12/11/2013,"12/11/2013"
"Drugs",65479,"Ongoing","Main Street Family Pharmacy, LLC","Newbern","TN","US","Voluntary: Firm Initiated","Telephone","nationwide, specifically: AK, AL, AZ, CA, CO, CT, DC, FL, GA, HI, IL, IN, KS, KY, LA, MA, MD, MN, MO, MS, NC, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, SC, TN, TX, UT, VA, WA, WI, and WV","D-311-2014","Class II","Triamcinolone Diacetate 40mg 2ml PF, Main Street Compounding Pharmacy, 126 East Main Street, Newbern, TN 38059, 888-658-6200","all codes distributed prior to and including 05/23/2013",".","3190 units","The firm received seven reports of adverse reactions in the form of skin abscesses potentially linked to compounded preservative-free methylprednisolone 80mg/ml 10 ml vials. ",5/28/2013,"05/28/2013",12/11/2013,"12/11/2013"
"Drugs",65479,"Ongoing","Main Street Family Pharmacy, LLC","Newbern","TN","US","Voluntary: Firm Initiated","Telephone","nationwide, specifically: AK, AL, AZ, CA, CO, CT, DC, FL, GA, HI, IL, IN, KS, KY, LA, MA, MD, MN, MO, MS, NC, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, SC, TN, TX, UT, VA, WA, WI, and WV","D-299-2014","Class II","Testosterone Pellets 100mg, Main Street Compounding Pharmacy, 126 East Main Street, Newbern, TN 38059, 888-658-6200","all codes distributed prior to and including 05/23/2013",".","21981 units","The firm received seven reports of adverse reactions in the form of skin abscesses potentially linked to compounded preservative-free methylprednisolone 80mg/ml 10 ml vials. ",5/28/2013,"05/28/2013",12/11/2013,"12/11/2013"
"Drugs",65479,"Ongoing","Main Street Family Pharmacy, LLC","Newbern","TN","US","Voluntary: Firm Initiated","Telephone","nationwide, specifically: AK, AL, AZ, CA, CO, CT, DC, FL, GA, HI, IL, IN, KS, KY, LA, MA, MD, MN, MO, MS, NC, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, SC, TN, TX, UT, VA, WA, WI, and WV","D-318-2014","Class II","Tri-Mix SS Pap 30mg, Phen 1mg, PGE1 10mcg 10ml, Main Street Compounding Pharmacy, 126 East Main Street, Newbern, TN 38059, 888-658-6200","all codes distributed prior to and including 05/23/2013",".","7 units","The firm received seven reports of adverse reactions in the form of skin abscesses potentially linked to compounded preservative-free methylprednisolone 80mg/ml 10 ml vials. ",5/28/2013,"05/28/2013",12/11/2013,"12/11/2013"
"Drugs",65479,"Ongoing","Main Street Family Pharmacy, LLC","Newbern","TN","US","Voluntary: Firm Initiated","Telephone","nationwide, specifically: AK, AL, AZ, CA, CO, CT, DC, FL, GA, HI, IL, IN, KS, KY, LA, MA, MD, MN, MO, MS, NC, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, SC, TN, TX, UT, VA, WA, WI, and WV","D-046-2014","Class II","B-12 mixture, Main Street Compounding Pharmacy, 126 East Main Street, Newbern, TN 38059, 888-658-6200","all codes distributed prior to and including 05/23/2013",".","196 units","The firm received seven reports of adverse reactions in the form of skin abscesses potentially linked to compounded preservative-free methylprednisolone 80mg/ml 10 ml vials. ",5/28/2013,"05/28/2013",12/11/2013,"12/11/2013"
"Drugs",65479,"Ongoing","Main Street Family Pharmacy, LLC","Newbern","TN","US","Voluntary: Firm Initiated","Telephone","nationwide, specifically: AK, AL, AZ, CA, CO, CT, DC, FL, GA, HI, IL, IN, KS, KY, LA, MA, MD, MN, MO, MS, NC, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, SC, TN, TX, UT, VA, WA, WI, and WV","D-119-2014","Class II","HCG 210 iu prefilled syringes, Main Street Compounding Pharmacy, 126 East Main Street, Newbern, TN 38059, 888-658-6200","all codes distributed prior to and including 05/23/2013",".","56 units","The firm received seven reports of adverse reactions in the form of skin abscesses potentially linked to compounded preservative-free methylprednisolone 80mg/ml 10 ml vials. ",5/28/2013,"05/28/2013",12/11/2013,"12/11/2013"
"Drugs",65479,"Ongoing","Main Street Family Pharmacy, LLC","Newbern","TN","US","Voluntary: Firm Initiated","Telephone","nationwide, specifically: AK, AL, AZ, CA, CO, CT, DC, FL, GA, HI, IL, IN, KS, KY, LA, MA, MD, MN, MO, MS, NC, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, SC, TN, TX, UT, VA, WA, WI, and WV","D-195-2014","Class II","Marcaine .1%/NS 450ml, Main Street Compounding Pharmacy, 126 East Main Street, Newbern, TN 38059, 888-658-6200","all codes distributed prior to and including 05/23/2013",".","24 units","The firm received seven reports of adverse reactions in the form of skin abscesses potentially linked to compounded preservative-free methylprednisolone 80mg/ml 10 ml vials. ",5/28/2013,"05/28/2013",12/11/2013,"12/11/2013"
"Drugs",65479,"Ongoing","Main Street Family Pharmacy, LLC","Newbern","TN","US","Voluntary: Firm Initiated","Telephone","nationwide, specifically: AK, AL, AZ, CA, CO, CT, DC, FL, GA, HI, IL, IN, KS, KY, LA, MA, MD, MN, MO, MS, NC, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, SC, TN, TX, UT, VA, WA, WI, and WV","D-190-2014","Class II","MALE HCG Pk, Main Street Compounding Pharmacy, 126 East Main Street, Newbern, TN 38059, 888-658-6200","all codes distributed prior to and including 05/23/2013",".","102 units","The firm received seven reports of adverse reactions in the form of skin abscesses potentially linked to compounded preservative-free methylprednisolone 80mg/ml 10 ml vials. ",5/28/2013,"05/28/2013",12/11/2013,"12/11/2013"
"Drugs",65479,"Ongoing","Main Street Family Pharmacy, LLC","Newbern","TN","US","Voluntary: Firm Initiated","Telephone","nationwide, specifically: AK, AL, AZ, CA, CO, CT, DC, FL, GA, HI, IL, IN, KS, KY, LA, MA, MD, MN, MO, MS, NC, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, SC, TN, TX, UT, VA, WA, WI, and WV","D-315-2014","Class II","Triamcinolone Diacetate 40mg 10ml, Main Street Compounding Pharmacy, 126 East Main Street, Newbern, TN 38059, 888-658-6200","all codes distributed prior to and including 05/23/2013",".","3592 units","The firm received seven reports of adverse reactions in the form of skin abscesses potentially linked to compounded preservative-free methylprednisolone 80mg/ml 10 ml vials. ",5/28/2013,"05/28/2013",12/11/2013,"12/11/2013"
"Drugs",65479,"Ongoing","Main Street Family Pharmacy, LLC","Newbern","TN","US","Voluntary: Firm Initiated","Telephone","nationwide, specifically: AK, AL, AZ, CA, CO, CT, DC, FL, GA, HI, IL, IN, KS, KY, LA, MA, MD, MN, MO, MS, NC, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, SC, TN, TX, UT, VA, WA, WI, and WV","D-232-2014","Class II","Mic B-Complex 30ml, Main Street Compounding Pharmacy, 126 East Main Street, Newbern, TN 38059, 888-658-6200","all codes distributed prior to and including 05/23/2013",".","152 units","The firm received seven reports of adverse reactions in the form of skin abscesses potentially linked to compounded preservative-free methylprednisolone 80mg/ml 10 ml vials. ",5/28/2013,"05/28/2013",12/11/2013,"12/11/2013"
"Drugs",65479,"Ongoing","Main Street Family Pharmacy, LLC","Newbern","TN","US","Voluntary: Firm Initiated","Telephone","nationwide, specifically: AK, AL, AZ, CA, CO, CT, DC, FL, GA, HI, IL, IN, KS, KY, LA, MA, MD, MN, MO, MS, NC, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, SC, TN, TX, UT, VA, WA, WI, and WV","D-268-2014","Class II","Sodium Hyaluronate. 2ml, Main Street Compounding Pharmacy, 126 East Main Street, Newbern, TN 38059, 888-658-6200","all codes distributed prior to and including 05/23/2013",".","712 units","The firm received seven reports of adverse reactions in the form of skin abscesses potentially linked to compounded preservative-free methylprednisolone 80mg/ml 10 ml vials. ",5/28/2013,"05/28/2013",12/11/2013,"12/11/2013"
"Drugs",65479,"Ongoing","Main Street Family Pharmacy, LLC","Newbern","TN","US","Voluntary: Firm Initiated","Telephone","nationwide, specifically: AK, AL, AZ, CA, CO, CT, DC, FL, GA, HI, IL, IN, KS, KY, LA, MA, MD, MN, MO, MS, NC, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, SC, TN, TX, UT, VA, WA, WI, and WV","D-044-2014","Class II","B-12 0.5ml prefilled syringe, Main Street Compounding Pharmacy, 126 East Main Street, Newbern, TN 38059, 888-658-6200","all codes distributed prior to and including 05/23/2013",".","116 units","The firm received seven reports of adverse reactions in the form of skin abscesses potentially linked to compounded preservative-free methylprednisolone 80mg/ml 10 ml vials. ",5/28/2013,"05/28/2013",12/11/2013,"12/11/2013"
"Drugs",65479,"Ongoing","Main Street Family Pharmacy, LLC","Newbern","TN","US","Voluntary: Firm Initiated","Telephone","nationwide, specifically: AK, AL, AZ, CA, CO, CT, DC, FL, GA, HI, IL, IN, KS, KY, LA, MA, MD, MN, MO, MS, NC, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, SC, TN, TX, UT, VA, WA, WI, and WV","D-152-2014","Class II","HCG Nasal Spray, Main Street Compounding Pharmacy, 126 East Main Street, Newbern, TN 38059, 888-658-6200","all codes distributed prior to and including 05/23/2013",".","43 units","The firm received seven reports of adverse reactions in the form of skin abscesses potentially linked to compounded preservative-free methylprednisolone 80mg/ml 10 ml vials. ",5/28/2013,"05/28/2013",12/11/2013,"12/11/2013"
"Drugs",65479,"Ongoing","Main Street Family Pharmacy, LLC","Newbern","TN","US","Voluntary: Firm Initiated","Telephone","nationwide, specifically: AK, AL, AZ, CA, CO, CT, DC, FL, GA, HI, IL, IN, KS, KY, LA, MA, MD, MN, MO, MS, NC, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, SC, TN, TX, UT, VA, WA, WI, and WV","D-282-2014","Class II","Test Cypionate/Prop 195/1.25mg/ml 10m, Main Street Compounding Pharmacy, 126 East Main Street, Newbern, TN 38059, 888-658-6200","all codes distributed prior to and including 05/23/2013",".","7 units","The firm received seven reports of adverse reactions in the form of skin abscesses potentially linked to compounded preservative-free methylprednisolone 80mg/ml 10 ml vials. ",5/28/2013,"05/28/2013",12/11/2013,"12/11/2013"
"Drugs",65479,"Ongoing","Main Street Family Pharmacy, LLC","Newbern","TN","US","Voluntary: Firm Initiated","Telephone","nationwide, specifically: AK, AL, AZ, CA, CO, CT, DC, FL, GA, HI, IL, IN, KS, KY, LA, MA, MD, MN, MO, MS, NC, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, SC, TN, TX, UT, VA, WA, WI, and WV","D-277-2014","Class II","Taper Pack C, Main Street Compounding Pharmacy, 126 East Main Street, Newbern, TN 38059, 888-658-6200","all codes distributed prior to and including 05/23/2013",".","842 units","The firm received seven reports of adverse reactions in the form of skin abscesses potentially linked to compounded preservative-free methylprednisolone 80mg/ml 10 ml vials. ",5/28/2013,"05/28/2013",12/11/2013,"12/11/2013"
"Food",65480,"Ongoing","Western Mixers Produce & Nuts, Inc.","Los Angeles","CA","US","Voluntary: Firm Initiated","Letter","CA, OH, UT, FL, WA, NV, OR, AZ, TX","F-1655-2013","Class I","Treasured Harvest-Raw, Shelled Pistachios, 5lbs & 1lb, 1 per carton","Lot Codes: 1lb size: 131540; 5lbs size: 131160, 131200, 131230, 131300, 131400; ",".","10,612 lbs total","Pistachios may be contaminated with Salmonella. ",6/11/2013,"06/11/2013",7/17/2013,"07/17/2013"
"Food",65480,"Ongoing","Western Mixers Produce & Nuts, Inc.","Los Angeles","CA","US","Voluntary: Firm Initiated","Letter","CA, OH, UT, FL, WA, NV, OR, AZ, TX","F-1654-2013","Class I","Treasured Harvest-Assorted Nut Trays, 28 oz, 6 per carton","Lot Codes: 123100, 122960, 123040",".","10,612 lbs total","Pistachios may be contaminated with Salmonella. ",6/11/2013,"06/11/2013",7/17/2013,"07/17/2013"
"Food",65480,"Ongoing","Western Mixers Produce & Nuts, Inc.","Los Angeles","CA","US","Voluntary: Firm Initiated","Letter","CA, OH, UT, FL, WA, NV, OR, AZ, TX","F-1653-2013","Class I","Treasured Harvest-Roasted & Salted Pistachios, 5lbs, 12oz, 6oz","Lot Codes: 6 oz. size: 123050, 123140, 123320, 123450, 123360, 130150, 130240, 130350; 12 oz. size: 130290; 5 lb. Size: 123550, 130020 ",".","10,612 lbs total","Pistachios may be contaminated with Salmonella. ",6/11/2013,"06/11/2013",7/17/2013,"07/17/2013"
"Veterinary",65481,"Ongoing","Diamondback Drugs of Delaware, LLC","Scottsdale","AZ","US","Voluntary: Firm Initiated","Letter","Nationwide in the US","V-220-2013","Class II","BUPRENORPHINE HCl PF (C) INJECTABLE STRENGTHS: 0.15 mg/ml , 0.6 mg/ml NDC: 49452825301, G9064-0122-10 ","LOTS: 130107:18@27, 130115:03@22, 130308:34@45, 130405:34@40, 130416:69@97, 1302026:46@22, 130118:95@126, 130401:77@17, 130521:85@124",,"8,068 units","Diamondback Drugs is recalling Buprenorphine HCL PF (C) Injectable due to an issue with the long-term stability of the product. Use of the Buprenorphine HCL PF (C) Injectable may not deliver the level of therapeutic relief from pain as expected.",6/10/2013,"06/10/2013",7/3/2013,"07/03/2013"
"Devices",65482,"Ongoing","Cordis Corporation","Miami Lakes","FL","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Worldwide Distribution - USA Nationwide in the states of AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, IA, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, Ny, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV, WY, including Hawaii and Puerto Rico and the countries of Canada & Panama","Z-1887-2013","Class I","Cordis OPTEASE Retrieval Inferior Vena Cava (IVC) Filter***REF Cat. No.***466F220A and 466F220B***Vena Cava Filter and Introduction Kit***(BRITE TIP Catheter Sheath Introducer and Angiographic Vessel Dilator)***Cordis***a Johnson and Johnson Company***ENDOVASCULAR*** Label No. SB 10247519.2/***LB466F220AO.5***omoraoro/2012.050794***Do not resterilize***. Product Usage: The OPTEASE Vena Cava Filter is indicated for use in the prevention of recurrent pulmonary embolism (PE) via percutaneous placement in the vena cava in several situations: Pulmonary thromboembolism when anticoagulants are contraindicated; Failure of anticoagulant therapy for thromboembolic disease; Emergency treatment following massive pulmonary embolism where anticipated benefits of conventional therapy are reduced and Chronic, recurrent pulmonary embolism where anticoagulant therapy has failed, or is contraindicated. ","Model Numbers 466F220A and 466F220B.",".","33,000 units","Correction to provide clarification and additional labeling to minimize likelihood on implanting filter backwards.",3/29/2013,"03/29/2013",8/14/2013,"08/14/2013"
"Drugs",65484,"Ongoing","Advance Pharmaceutical Inc","Holtsville","NY","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Nationwide","D-919-2013","Class I","ENTERIC COATED ASPIRIN (NSAID), 81 mg, 120-count tablets per bottle, distributed by: Rugby Laboratories, Inc., Duluth, Georgia 30097, NDC 0536-3086-41, UPC 3 0536-3086-41 9.","Lot #: 13A026, Exp 01/15",,"16,440 bottles","Labeling: Label Mix-Up: A complaint from a pharmacist was received that the entire contents of 1 bottle labeled as Rugby label Enteric Coated Aspirin 81 mg Tablets actually contained Acetaminophen 500 mg Tablets.",6/17/2013,"06/17/2013",9/4/2013,"09/04/2013"
"Devices",65485,"Ongoing","Genzyme Corporation, A Sanofi Company","Woburn","MA","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution - USA (nationwide) and internationally to Austria, Belgium, Canada, Denmark, Egypt. Europe, Finland, France, Germany, Hong Kong, Ireland, Italy, Netherlands, Poland, Saudi Arabia, Slovena, Spain, Sweden, Switzerland, The Netherlands, Turkey, and UK.","Z-2156-2013","Class II","LeGoo Endovascular Occlusion Gel 2.5 mL Product Number: LG250IT LeGoo is a water-soluble, biocompatible polymer with reverse thermo-sensitive properties allowing it to be injected as a soft viscoelastic gel that forms an elastic plug within the vessel. LeGoo is indicated for temporary endovascular occlusion of blood vessels up to 4 mm in diameter below the neck.","All lot codes",".","100 units","Product contains particulates (fibers)",6/21/2013,"06/21/2013",9/11/2013,"09/11/2013"
"Devices",65485,"Ongoing","Genzyme Corporation, A Sanofi Company","Woburn","MA","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution - USA (nationwide) and internationally to Austria, Belgium, Canada, Denmark, Egypt. Europe, Finland, France, Germany, Hong Kong, Ireland, Italy, Netherlands, Poland, Saudi Arabia, Slovena, Spain, Sweden, Switzerland, The Netherlands, Turkey, and UK.","Z-2147-2013","Class II","LeGoo Endovascular Occlusion Gel-2.5 mL LeGoo with 1 Cannula Pouch Product Number: LG250 LeGoo is a water-soluble, biocompatible polymer with reverse thermo-sensitive properties allowing it to be injected as a soft viscoelastic gel that forms an elastic plug within the vessel. LeGoo is indicated for temporary endovascular occlusion of blood vessels up to 4 mm in diameter below the neck.","All lot codes",".","181 units","Product contains particulates (fibers)",6/21/2013,"06/21/2013",9/11/2013,"09/11/2013"
"Devices",65485,"Ongoing","Genzyme Corporation, A Sanofi Company","Woburn","MA","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution - USA (nationwide) and internationally to Austria, Belgium, Canada, Denmark, Egypt. Europe, Finland, France, Germany, Hong Kong, Ireland, Italy, Netherlands, Poland, Saudi Arabia, Slovena, Spain, Sweden, Switzerland, The Netherlands, Turkey, and UK.","Z-2150-2013","Class II","LeGoo Internal Vessel Occluder 1mL Product Number: 10-0100 LeGoo is a water-soluble, biocompatible polymer with reverse thermo-sensitive properties allowing it to be injected as a soft viscoelastic gel that forms an elastic plug within the vessel. LeGoo is indicated for temporary endovascular occlusion of blood vessels up to 4 mm in diameter below the neck.","All lot codes",".","652 units","Product contains particulates (fibers)",6/21/2013,"06/21/2013",9/11/2013,"09/11/2013"
"Devices",65485,"Ongoing","Genzyme Corporation, A Sanofi Company","Woburn","MA","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution - USA (nationwide) and internationally to Austria, Belgium, Canada, Denmark, Egypt. Europe, Finland, France, Germany, Hong Kong, Ireland, Italy, Netherlands, Poland, Saudi Arabia, Slovena, Spain, Sweden, Switzerland, The Netherlands, Turkey, and UK.","Z-2153-2013","Class II","LeGoo Internal Vessel Occluder 10mL Product Number: 10-1000 LeGoo is a water-soluble, biocompatible polymer with reverse thermo-sensitive properties allowing it to be injected as a soft viscoelastic gel that forms an elastic plug within the vessel. LeGoo is indicated for temporary endovascular occlusion of blood vessels up to 4 mm in diameter below the neck.","All lot codes",".","37 units","Product contains particulates (fibers)",6/21/2013,"06/21/2013",9/11/2013,"09/11/2013"
"Devices",65485,"Ongoing","Genzyme Corporation, A Sanofi Company","Woburn","MA","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution - USA (nationwide) and internationally to Austria, Belgium, Canada, Denmark, Egypt. Europe, Finland, France, Germany, Hong Kong, Ireland, Italy, Netherlands, Poland, Saudi Arabia, Slovena, Spain, Sweden, Switzerland, The Netherlands, Turkey, and UK.","Z-2145-2013","Class II","LeGoo Endovascular Occlusion Gel- 0.5 mL LeGoo with 3 Cannula Pouch Product Number: LG50 LeGoo is a water-soluble, biocompatible polymer with reverse thermo-sensitive properties allowing it to be injected as a soft viscoelastic gel that forms an elastic plug within the vessel. LeGoo is indicated for temporary endovascular occlusion of blood vessels up to 4 mm in diameter below the neck.","All lot codes",".","660 units","Product contains particulates (fibers)",6/21/2013,"06/21/2013",9/11/2013,"09/11/2013"
"Devices",65485,"Ongoing","Genzyme Corporation, A Sanofi Company","Woburn","MA","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution - USA (nationwide) and internationally to Austria, Belgium, Canada, Denmark, Egypt. Europe, Finland, France, Germany, Hong Kong, Ireland, Italy, Netherlands, Poland, Saudi Arabia, Slovena, Spain, Sweden, Switzerland, The Netherlands, Turkey, and UK.","Z-2152-2013","Class II","LeGoo Internal Vessel Occluder 5mL Product Number: 10-0500 LeGoo is a water-soluble, biocompatible polymer with reverse thermo-sensitive properties allowing it to be injected as a soft viscoelastic gel that forms an elastic plug within the vessel. LeGoo is indicated for temporary endovascular occlusion of blood vessels up to 4 mm in diameter below the neck.","All lot codes",".","308 units","Product contains particulates (fibers)",6/21/2013,"06/21/2013",9/11/2013,"09/11/2013"
"Devices",65485,"Ongoing","Genzyme Corporation, A Sanofi Company","Woburn","MA","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution - USA (nationwide) and internationally to Austria, Belgium, Canada, Denmark, Egypt. Europe, Finland, France, Germany, Hong Kong, Ireland, Italy, Netherlands, Poland, Saudi Arabia, Slovena, Spain, Sweden, Switzerland, The Netherlands, Turkey, and UK.","Z-2148-2013","Class II","LeGoo Internal Vessel Occluder .25mL Product Number: 10-0025 LeGoo is a water-soluble, biocompatible polymer with reverse thermo-sensitive properties allowing it to be injected as a soft viscoelastic gel that forms an elastic plug within the vessel. LeGoo is indicated for temporary endovascular occlusion of blood vessels up to 4 mm in diameter below the neck.","All lot codes",".","448 units","Product contains particulates (fibers)",6/21/2013,"06/21/2013",9/11/2013,"09/11/2013"
"Devices",65485,"Ongoing","Genzyme Corporation, A Sanofi Company","Woburn","MA","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution - USA (nationwide) and internationally to Austria, Belgium, Canada, Denmark, Egypt. Europe, Finland, France, Germany, Hong Kong, Ireland, Italy, Netherlands, Poland, Saudi Arabia, Slovena, Spain, Sweden, Switzerland, The Netherlands, Turkey, and UK.","Z-2149-2013","Class II","LeGoo Internal Vessel Occluder .5mL Product Number: 10-0050 LeGoo is a water-soluble, biocompatible polymer with reverse thermo-sensitive properties allowing it to be injected as a soft viscoelastic gel that forms an elastic plug within the vessel. LeGoo is indicated for temporary endovascular occlusion of blood vessels up to 4 mm in diameter below the neck.","All lot codes",".","776 units","Product contains particulates (fibers)",6/21/2013,"06/21/2013",9/11/2013,"09/11/2013"
"Devices",65485,"Ongoing","Genzyme Corporation, A Sanofi Company","Woburn","MA","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution - USA (nationwide) and internationally to Austria, Belgium, Canada, Denmark, Egypt. Europe, Finland, France, Germany, Hong Kong, Ireland, Italy, Netherlands, Poland, Saudi Arabia, Slovena, Spain, Sweden, Switzerland, The Netherlands, Turkey, and UK.","Z-2139-2013","Class II","LeGoo Endovascular Occlusion Gel-0.25 mL LeGoo with 3 Cannula Pouch Product Number: CS-25 LeGoo is a water-soluble, biocompatible polymer with reverse thermo-sensitive properties allowing it to be injected as a soft viscoelastic gel that forms an elastic plug within the vessel. LeGoo is indicated for temporary endovascular occlusion of blood vessels up to 4 mm in diameter below the neck.","All lot codes",".","30 units","Product contains particulates (fibers)",6/21/2013,"06/21/2013",9/11/2013,"09/11/2013"
"Devices",65485,"Ongoing","Genzyme Corporation, A Sanofi Company","Woburn","MA","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution - USA (nationwide) and internationally to Austria, Belgium, Canada, Denmark, Egypt. Europe, Finland, France, Germany, Hong Kong, Ireland, Italy, Netherlands, Poland, Saudi Arabia, Slovena, Spain, Sweden, Switzerland, The Netherlands, Turkey, and UK.","Z-2143-2013","Class II","LeGoo Endovascular Occlusion Gel- 1.0 mL LeGoo w/ no Cannula Product Number: PV-100 LeGoo is a water-soluble, biocompatible polymer with reverse thermo-sensitive properties allowing it to be injected as a soft viscoelastic gel that forms an elastic plug within the vessel. LeGoo is indicated for temporary endovascular occlusion of blood vessels up to 4 mm in diameter below the neck.","All lot codes",".","45 units","Product contains particulates (fibers)",6/21/2013,"06/21/2013",9/11/2013,"09/11/2013"
"Devices",65485,"Ongoing","Genzyme Corporation, A Sanofi Company","Woburn","MA","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution - USA (nationwide) and internationally to Austria, Belgium, Canada, Denmark, Egypt. Europe, Finland, France, Germany, Hong Kong, Ireland, Italy, Netherlands, Poland, Saudi Arabia, Slovena, Spain, Sweden, Switzerland, The Netherlands, Turkey, and UK.","Z-2155-2013","Class II","LeGoo Endovascular Occlusion Gel 1.0 mL Product Number: LG100IT LeGoo is a water-soluble, biocompatible polymer with reverse thermo-sensitive properties allowing it to be injected as a soft viscoelastic gel that forms an elastic plug within the vessel. LeGoo is indicated for temporary endovascular occlusion of blood vessels up to 4 mm in diameter below the neck.","All lot codes",".","220 units","Product contains particulates (fibers)",6/21/2013,"06/21/2013",9/11/2013,"09/11/2013"
"Devices",65485,"Ongoing","Genzyme Corporation, A Sanofi Company","Woburn","MA","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution - USA (nationwide) and internationally to Austria, Belgium, Canada, Denmark, Egypt. Europe, Finland, France, Germany, Hong Kong, Ireland, Italy, Netherlands, Poland, Saudi Arabia, Slovena, Spain, Sweden, Switzerland, The Netherlands, Turkey, and UK.","Z-2154-2013","Class II","LeGoo Endovascular Occlusion Gel 0.5 mL Product Number: LG50IT LeGoo is a water-soluble, biocompatible polymer with reverse thermo-sensitive properties allowing it to be injected as a soft viscoelastic gel that forms an elastic plug within the vessel. LeGoo is indicated for temporary endovascular occlusion of blood vessels up to 4 mm in diameter below the neck.","All lot codes",".","110 units","Product contains particulates (fibers)",6/21/2013,"06/21/2013",9/11/2013,"09/11/2013"
"Devices",65485,"Ongoing","Genzyme Corporation, A Sanofi Company","Woburn","MA","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution - USA (nationwide) and internationally to Austria, Belgium, Canada, Denmark, Egypt. Europe, Finland, France, Germany, Hong Kong, Ireland, Italy, Netherlands, Poland, Saudi Arabia, Slovena, Spain, Sweden, Switzerland, The Netherlands, Turkey, and UK.","Z-2146-2013","Class II","LeGoo Endovascular Occlusion Gel- 1.0 mL LeGoo with 3 Cannula Pouch Product Number: LG100 LeGoo is a water-soluble, biocompatible polymer with reverse thermo-sensitive properties allowing it to be injected as a soft viscoelastic gel that forms an elastic plug within the vessel. LeGoo is indicated for temporary endovascular occlusion of blood vessels up to 4 mm in diameter below the neck.","All lot codes",".","994 units","Product contains particulates (fibers)",6/21/2013,"06/21/2013",9/11/2013,"09/11/2013"
"Devices",65485,"Ongoing","Genzyme Corporation, A Sanofi Company","Woburn","MA","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution - USA (nationwide) and internationally to Austria, Belgium, Canada, Denmark, Egypt. Europe, Finland, France, Germany, Hong Kong, Ireland, Italy, Netherlands, Poland, Saudi Arabia, Slovena, Spain, Sweden, Switzerland, The Netherlands, Turkey, and UK.","Z-2151-2013","Class II","LeGoo Internal Vessel Occluder 2.5mL Product Number: 10-0250 LeGoo is a water-soluble, biocompatible polymer with reverse thermo-sensitive properties allowing it to be injected as a soft viscoelastic gel that forms an elastic plug within the vessel. LeGoo is indicated for temporary endovascular occlusion of blood vessels up to 4 mm in diameter below the neck.","All lot codes",".","331 units","Product contains particulates (fibers)",6/21/2013,"06/21/2013",9/11/2013,"09/11/2013"
"Devices",65485,"Ongoing","Genzyme Corporation, A Sanofi Company","Woburn","MA","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution - USA (nationwide) and internationally to Austria, Belgium, Canada, Denmark, Egypt. Europe, Finland, France, Germany, Hong Kong, Ireland, Italy, Netherlands, Poland, Saudi Arabia, Slovena, Spain, Sweden, Switzerland, The Netherlands, Turkey, and UK.","Z-2142-2013","Class II","LeGoo Endovascular Occlusion Gel-0.5 mL LeGoo w/ no Cannula Product Number: PV-50 LeGoo is a water-soluble, biocompatible polymer with reverse thermo-sensitive properties allowing it to be injected as a soft viscoelastic gel that forms an elastic plug within the vessel. LeGoo is indicated for temporary endovascular occlusion of blood vessels up to 4 mm in diameter below the neck.","All lot codes",".","5 units","Product contains particulates (fibers)",6/21/2013,"06/21/2013",9/11/2013,"09/11/2013"
"Devices",65485,"Ongoing","Genzyme Corporation, A Sanofi Company","Woburn","MA","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution - USA (nationwide) and internationally to Austria, Belgium, Canada, Denmark, Egypt. Europe, Finland, France, Germany, Hong Kong, Ireland, Italy, Netherlands, Poland, Saudi Arabia, Slovena, Spain, Sweden, Switzerland, The Netherlands, Turkey, and UK.","Z-2144-2013","Class II","LeGoo Endovascular Occlusion Gel-2.5 mL LeGoo w/ no Cannula Product Number: PV-250 LeGoo is a water-soluble, biocompatible polymer with reverse thermo-sensitive properties allowing it to be injected as a soft viscoelastic gel that forms an elastic plug within the vessel. LeGoo is indicated for temporary endovascular occlusion of blood vessels up to 4 mm in diameter below the neck.","All lot codes",".","250 units","Product contains particulates (fibers)",6/21/2013,"06/21/2013",9/11/2013,"09/11/2013"
"Devices",65485,"Ongoing","Genzyme Corporation, A Sanofi Company","Woburn","MA","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution - USA (nationwide) and internationally to Austria, Belgium, Canada, Denmark, Egypt. Europe, Finland, France, Germany, Hong Kong, Ireland, Italy, Netherlands, Poland, Saudi Arabia, Slovena, Spain, Sweden, Switzerland, The Netherlands, Turkey, and UK.","Z-2141-2013","Class II","LeGoo Endovascular Occlusion Gel-1.0 mL LeGoo with 3 Cannula Pouch Product Number: CS-100 LeGoo is a water-soluble, biocompatible polymer with reverse thermo-sensitive properties allowing it to be injected as a soft viscoelastic gel that forms an elastic plug within the vessel. LeGoo is indicated for temporary endovascular occlusion of blood vessels up to 4 mm in diameter below the neck.","All lot codes",".","100 units","Product contains particulates (fibers)",6/21/2013,"06/21/2013",9/11/2013,"09/11/2013"
"Devices",65485,"Ongoing","Genzyme Corporation, A Sanofi Company","Woburn","MA","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution - USA (nationwide) and internationally to Austria, Belgium, Canada, Denmark, Egypt. Europe, Finland, France, Germany, Hong Kong, Ireland, Italy, Netherlands, Poland, Saudi Arabia, Slovena, Spain, Sweden, Switzerland, The Netherlands, Turkey, and UK.","Z-2140-2013","Class II","LeGoo Endovascular Occlusion Gel-0.5 mL LeGoo with 3 Cannula Pouch Product Number: CS-50 LeGoo is a water-soluble, biocompatible polymer with reverse thermo-sensitive properties allowing it to be injected as a soft viscoelastic gel that forms an elastic plug within the vessel. LeGoo is indicated for temporary endovascular occlusion of blood vessels up to 4 mm in diameter below the neck.","All lot codes",".","65 units","Product contains particulates (fibers)",6/21/2013,"06/21/2013",9/11/2013,"09/11/2013"
"Devices",65486,"Ongoing","Stryker Instruments Div. of Stryker Corporation","Portage","MI","US","Voluntary: Firm Initiated","Letter","Worldwide - USA Nationwide including the states of CA, CO, FL, HI, IA, IL, KS, KY, LA, MD, MI, MN, MS, NC, NH, NJ, NV, NY, OH, PA, TX, VA, ITALY, and the countries of AUSTRALIA, CANADA, UNITED KINGDOM, NETHERLANDS, INDIA, JAPAN, NEW ZEALAND, SWITZERLAND, HONG KONG, and TAIWAN.","Z-1879-2013","Class II","Sonopet Ultrasonic Aspirator Console 5450-851-000(Console 100V) Product Usage: The Sonopet Console is indicated for use in surgical procedures where fragmentation, emulsification, and aspiration of soft and hard tissue is desirable, including neurosurgery, gastrointestinal and affiliated organ surgery, urological surgery, plastic and reconstructive surgery, general surgery, orthopedic surgery, gynecological surgery, thoracic surgery, laparoscopic surgery, and thoracoscopic surgery. ","5450-851-000(Console 100V) S/N 1127900134, 1133400114, 1202400224, 1205800094, 1226800284, 1127900144, 1133400124, 1202400234, 1205800104, 1226800294, 1127900154, 1133400134, 1202400244, 1206200574, 1226800304, 1127900164, 1133400144, 1203700594, 1206200584, 1228500194, 1127900174, 1133400154, 1203700604, 1206200594, 1228500204, 1127900184, 1133900014, 1205100514, 1222800034, 1228500214, 1127900194, 1133900024, 1205100524, 1222800044, 01J0018, 1127900204, 1133900034, 1205100534, 1224800314, 02B0052, 1130500054, 1133900044, 1205100544, 1225500084, 02G0091, 1130500064, 1133900054, 1205100554, 1225500094, 05H0386, 1130500074, 1201300384, 1205100564, 1225500104, 1130500084, 1202400154, 1205100574, 1225500114, 1130800374, 1202400164, 1205100584, 1225500124, 1130800384, 1202400174, 1205100594, 1226800234, 1130800394, 1202400184, 1205100604, 1226800244, 1130800404, 1202400194, 1205800064, 1226800254, 1130800414, 1202400204, 1205800074, 1226800264, 1130800424, 1202400214, 1205800084, 1226800274. ",".","215 units total","A supplied component exhibiting corrosion was built into the power supply boards of the Sonopet Consoles listed above. The issue is limited to 2 lots of the supplied component. The presence of the corrosion on the relay of the power supply board can potentially lead to a conduction defect which could cause the irrigation pump to stop working. The purpose of the irrigation pump is to supply saline solution to the end of the handpiece tip. If the irrigation pump stopped, the saline would not be supplied to the tip end, resulting in the loss of the cooling function and potentially cause the tip to heat up. The devices affected were distributed October 13, 2011 through October 19, 2012.",6/24/2013,"06/24/2013",8/14/2013,"08/14/2013"
"Devices",65486,"Ongoing","Stryker Instruments Div. of Stryker Corporation","Portage","MI","US","Voluntary: Firm Initiated","Letter","Worldwide - USA Nationwide including the states of CA, CO, FL, HI, IA, IL, KS, KY, LA, MD, MI, MN, MS, NC, NH, NJ, NV, NY, OH, PA, TX, VA, ITALY, and the countries of AUSTRALIA, CANADA, UNITED KINGDOM, NETHERLANDS, INDIA, JAPAN, NEW ZEALAND, SWITZERLAND, HONG KONG, and TAIWAN.","Z-1880-2013","Class II","Sonopet Ultrasonic Aspirator Console 5450-852-000 (Console 230V) Product Usage: The Sonopet Console is indicated for use in surgical procedures where fragmentation, emulsification, and aspiration of soft and hard tissue is desirable, including neurosurgery, gastrointestinal and affiliated organ surgery, urological surgery, plastic and reconstructive surgery, general surgery, orthopedic surgery, gynecological surgery, thoracic surgery, laparoscopic surgery, and thoracoscopic surgery. ","5450-852-000 (Console 230V) with SN: 1134000114, 1206800484 1210900274, 1134000124, 1206800494, 1210900284,1134000134 1206800504, 1210900294, 1134000144, 1206800514, 1210900304, 1134000154, 1206800524, 1211800064, 1134000164, 1206800534, 1211800074, 1134000174, 1206800544, 1211800084, 1134000184, 1208700014, 1211800094, 1134000194, 1208700024, 1212900014, 1134000204, 1208700034, 1213100114, 1201700324, 1208700044, 1213100124, 1201700334, 1208700054, 1213100134, 1201700344, 1209400164, 1213100144, 1201700354, 1209400174, 1213100154, 1201700364, 1209400184,1206500014, 1209400194, 1206500024, 1209400204, 1206500034, and 1210900264.",".","215 units total","A supplied component exhibiting corrosion was built into the power supply boards of the Sonopet Consoles listed above. The issue is limited to 2 lots of the supplied component. The presence of the corrosion on the relay of the power supply board can potentially lead to a conduction defect which could cause the irrigation pump to stop working. The purpose of the irrigation pump is to supply saline solution to the end of the handpiece tip. If the irrigation pump stopped, the saline would not be supplied to the tip end, resulting in the loss of the cooling function and potentially cause the tip to heat up. The devices affected were distributed October 13, 2011 through October 19, 2012.",6/24/2013,"06/24/2013",8/14/2013,"08/14/2013"
"Devices",65486,"Ongoing","Stryker Instruments Div. of Stryker Corporation","Portage","MI","US","Voluntary: Firm Initiated","Letter","Worldwide - USA Nationwide including the states of CA, CO, FL, HI, IA, IL, KS, KY, LA, MD, MI, MN, MS, NC, NH, NJ, NV, NY, OH, PA, TX, VA, ITALY, and the countries of AUSTRALIA, CANADA, UNITED KINGDOM, NETHERLANDS, INDIA, JAPAN, NEW ZEALAND, SWITZERLAND, HONG KONG, and TAIWAN.","Z-1878-2013","Class II","Sonopet Ultrasonic Aspirator Console (Console 110V with Pedal & Pole) Product Usage: The Sonopet Console is indicated for use in surgical procedures where fragmentation, emulsification, and aspiration of soft and hard tissue is desirable, including neurosurgery, gastrointestinal and affiliated organ surgery, urological surgery, plastic and reconstructive surgery, general surgery, orthopedic surgery, gynecological surgery, thoracic surgery, laparoscopic surgery, and thoracoscopic surgery. ","5450-850-000 (Console 110V with Pedal & Pole) S/N 1131300134, 1131900074, 1200500134, 1203200244, 1210100114, 1131300144, 1131900084, 1200500144, 1203200254, 1210100124, 1131300154, 1131900094, 1200500154, 1203200274, 1210100134, 1131300164, 1131900104, 1200500164, 1203700954, 1210100144, 1131300174, 1131900114, 1200500174, 1203700964, 1210100154, 1131300184, 1131900124, 1200500184, 1203700974, 1210700014, 1131300194, 1132800114, 1200500194, 1203900024, 1210700024, 1131300204, 1132800124, 1200500204, 1204000044, 1210700034, 1131300214, 1132800134, 1201300494, 1204000054, 1210700044, 1131300224, 1132800144, 1201300544, 1207400154, 1210700054, 1131300234, 1132800154, 1201300754, 1207400164, 1213800114, 1131300244, 1132800164, 1201300764, 1207400174, 1213800124, 1131900014, 1132800174, 1201300774, 1207400184, 1213800134, 1131900024, 1132800184, 1201300784, 1208300014, 1213800144, 1131900034, 1132800194, 1201300794, 1208300024, 1213800154, 1131900044, 1132800204, 1203200214, 1208300034, 1131900054, 1200500114, 1203200224, 1208300044, 1131900064, 1200500124, 1203200234, 1208300054. ",".","215 units total","A supplied component exhibiting corrosion was built into the power supply boards of the Sonopet Consoles listed above. The issue is limited to 2 lots of the supplied component. The presence of the corrosion on the relay of the power supply board can potentially lead to a conduction defect which could cause the irrigation pump to stop working. The purpose of the irrigation pump is to supply saline solution to the end of the handpiece tip. If the irrigation pump stopped, the saline would not be supplied to the tip end, resulting in the loss of the cooling function and potentially cause the tip to heat up. The devices affected were distributed October 13, 2011 through October 19, 2012.",6/24/2013,"06/24/2013",8/14/2013,"08/14/2013"
"Devices",65487,"Ongoing","Siemens Medical Solutions USA, Inc","Malvern","PA","US","Voluntary: Firm Initiated","Letter","United States Nationwide Distribution in the states of ND, OH and SC.","Z-1694-2013","Class II","Siemens Mammomat Inspiration - full-field digital mammography Product Usage: Mammography","Model number 10140000, serial numbers 3118, 3243 and 3309",".","3","Firm became aware of an unintended behavior when using the Mammomat Inspiration. The possibility exists that a malfunction may occur during Stereo or Tomo acquisitions if the tomo clutch was incorrectly adjusted. Although the possibility is rare, the system could move while a patient's breast is compressed resulting in a possible bruise. Firm released Update Instructions XP031/12/S for this issue, and a Siemens Service Engineer has inspected the units and made any adjustments necessary.",2/28/2013,"02/28/2013",7/17/2013,"07/17/2013"
"Devices",65488,"Ongoing","National Biological Corp","Beachwood","OH","US","Voluntary: Firm Initiated","Letter","Worldwide distribution: US (nationwide) including states of: AL, CA, CO, CT, FL, GA, IA, ID, IL, LA, MA, MN, MO, MS, NE, NJ, NY, OH, PA, SC, TN, TX, VA, WA, and WI; and countries of: Canada, Brazil, Malaysia, and Mexico.","Z-1778-2013","Class III","Dermalight 80 Model Number UVB-080, one unit per box. The Dermalight 80 is a Phototherapy light unit that provides ultraviolet radiation therapy for diagnosed skin disorders such as Psoriasis and Vitiligo.","The following batch numbers and serial numbers are affected by this recall: Batches 7839 and 7951, Serial numbers D80-12748 to D80-12871. ",,"124 units","The incorrect manual may have been packaged with this product. UVB-080 devices may have included the manual for a UVA-083 device.",4/9/2013,"04/09/2013",7/31/2013,"07/31/2013"
"Food",65489,"Ongoing","Nassau Candy","Hicksville","NY","US","Voluntary: Firm Initiated","FAX","NY, NJ, CT, ME, PA, MD, NC, IN, TX, IL, FL, UT, CO","F-1719-2013","Class I","PISTACHIOS-INSHELL-R/S-21/25-6.25LB, Net Wt. 6.25 LB. Item number: 920. Product is packed in a clear plastic liner then in a white corrugated bag. Distributed by Nassau Candy 530 West John Street Hicksville, NY 11801.","Lot codes: C1306 through F1306",".","8,000 LB (1,280 packages)","Potential Salmonella contamination.",6/10/2013,"06/10/2013",7/24/2013,"07/24/2013"
"Devices",65491,"Ongoing","Siemens Medical Solutions USA, Inc","Malvern","PA","US","Voluntary: Firm Initiated","Letter","US Distribution including the states of CA, IN, NJ and OK.","Z-1848-2013","Class II","Siemens Luminos dRF Fluoroscopic X-Ray system Fluoroscopic X-Ray system ","Model number 10094200, serial numbers 4024, 4077, 4043 and 4051",,"4","Siemens became aware of an unintended behavior when using the Luminos dRF with software version VD10A. The possibility exists that a software error may occur causing the table to tilt into an upright position and may collide with the floor. Four consignees were notified of this recall by Update Instruction XP067/12/S -- all four units have been corrected.",5/7/2013,"05/07/2013",8/7/2013,"08/07/2013"
"Devices",65492,"Ongoing","Edwards Lifesciences, LLC","Draper","UT","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution - USA (nationwide) and Canada.","Z-1749-2013","Class II","Edwards Lifesciences Suction Wand, models S099 and S0998B Suction wands are intended for hand held use and pericardial sumps are intended for stationary use in removing excess fluid from the surgical field. ","Models S099 and S099B",".","S099: 171,587 units and S099B: 505,107 units","Edwards is recalling certain lots of Rigid Suction Wands because they discovered plastic particulate inside the sterile pouch and within the internal diam ether of the wand.",6/19/2013,"06/19/2013",7/24/2013,"07/24/2013"
"Devices",65493,"Ongoing","DJO, LLC","Vista","CA","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution - USA Nationwide and countries of: Australia, Belgium, China, Guatemala CentroAmeria, France, Hong Kong, India,Italy, Korea, Lebanon, Malaysia, Morocco, Pakistan, Paraguay, The Netherlands, Romania, Singapore, Spain, Sweden, Thailand, Turkey, United Arab Emirates, United Kingdom and Venezula, ","Z-1661-2013","Class II","VenaFlow Elite 30B-B and 30BI-B Product Usage: The VenaFlow Elite System is a compression pump used for the prevention of Deep Vein Thrombosis.","Model Numbers: 30B-B and 30BI-B. Serial Numbers: E00026 E00029 E00030 E00031 E00036 E00039 E00045 E00050 E00051 E00052 E00053 E00056 E00057 E00058 E00060 E00143 E00147 E00151 E00156 E00163 E00169 E00175 E00178 E00184 E00191 E00200 E00201 E00203 E00205 E00206 E00211 E00211 E00222 E00227 E00234 E00236 E00238 E00239 E00240 E00241 E00242 E00243 E00245 E00246 E00247 E00248 E00250 E00252 E00258 E00260 E00261 E00262 E00264 E00267 E00269 E00271 E00272 E00273 E00274 E00276 E00281 E00283 E00289 E00296 E00298 E00301 E00303 E00305 E00306 E00308 E00313 E00314 E00315 E00317 E00321 E00322 E00326 E00329 E00330 E00332 E00335 E00336 E00337 E00339 E00340 E00342 E00344 E00347 E00348 E00351 E00352 E00357 E00358 E00363 E00368 E00370 E00371 E00373 E00375 E00376 E00377 E00379 E00380 E00381 E00384 E00385 E00388 E00390 E00391 E00392 E00393 E00394 E00395 E00396 E00397 E00398 E00399 E00400 E00401 E00402 E00403 E00404 E00406 E00407 E00408 E00409 E00410 E00411 E00412 E00413 E00414 E00415 E00416 E00417 E00418 E00419 E00420 E00422 E00426 E00429 E00430 E00432 E00433 E00434 E00436 E00437 E00439 E00492 E00503 E00516 E00529 E00533 E00540 E00541 E00543 E00546 E00548 E00559 E00563 E00570 E00576 E00577 E00580 E00582 E00583 E00584 E00585 E00589 E00590 E00591 E00594 E00595 E00596 E00598 E00599 E00600 E00602 E00604 E00605 E00606 E00607 E00608 E00609 E00610 E00611 E00612 E00613 E00614 E00615 E00616 E00617 E00618 E00619 E00620 E00621 E00622 E00623 E00628 E00629 E00630 E00631 E00632 E00634 E00635 E00636 E00637 E00638 E00639 E00642 E00643 E00644 E00645 E00646 E00647 E00649 E00651 E00652 E00656 E00657 E00658 E00659 E00660 E00661 E00662 E00663 E00664 E00665 E00666 E00669 E00670 E00672 E00673 E00675 E00676 E00677 E00679 E00680 E00682 E00683 E00686 E00687 E00688 E00689 E00692 E00693 E00696 E00698 E00699 E00700 E00701 E00703 E00704 E00705 E00706 E00707 E00708 E00710 E00712 E00714 E00715 E00716 E00718 E00719 E00720 E00723 E00724 E00725 E00727 E00728 E00730 E00733 E00734 E00735 E00736 E00737 E00739 E00740 E00741 E00743 E00744 E00745 E00746 E00747 E00748 E00749 E",".","2491","DJO, LLC has recently identified a product safety issue with the battery assembly for the VenaFlow 30B-B and 30 BI-B products. There is a potential for battery leakage which could result in thermal meltdown (fire).",5/28/2013,"05/28/2013",7/10/2013,"07/10/2013"
"Devices",65494,"Ongoing","National Biological Corp","Beachwood","OH","US","Voluntary: Firm Initiated","Letter","US distribution including the states of: AL, CA, MN, and NC.","Z-1779-2013","Class III","Dermalight 80 Model Number UVB-083, one unit per box. The Dermalight 80 is a Phototherapy light unit that provides ultraviolet radiation therapy for diagnosed skin disorders such as Psoriasis and Vitiligo.","The following batch and serial numbers are affected by the recall: Batch 007778, Serial numbers D83-30016 to D83-30021. ",,"6 units","The incorrect manual may have been packaged with this product. UVB-083 devices may have included the manual for a UVA-080 device.",4/8/2013,"04/08/2013",7/31/2013,"07/31/2013"
"Drugs",65495,"Ongoing","American Health Packaging","Columbus","OH","US","Voluntary: Firm Initiated","Letter","Nationwide.","D-856-2013","Class II","Zolpidem Tartrate Tablets 5 mg, 10 tablets per blister, 10 blisters per carton, 100 cartons per box, Rx Only, Manufactured for Wockhardt USA LLC., Parsippany, NJ 07054 by Wockhardt Limited, Mumbai, India, NDC 68084-225-01","Lot #: 114215, Exp 7/13; 114216, Exp 7/13; 114217, Exp 7/13; 120087, Exp 9/13; 120295, Exp 9/13; 121573, Exp 6/14; 123572, Exp 9/14; 123983, Exp 9/14; 130071, Exp 2/15",".","48.230 carton units","Unit Dose Mispackaging: This recall event is due to a random undetected packaging issue which could increase the potential for a small number of individual unit dose blisters to be packed with more than one tablet.",5/21/2013,"05/21/2013",8/14/2013,"08/14/2013"
"Drugs",65496,"Ongoing","Astellas Pharma US Inc","Northbrook","IL","US","Voluntary: Firm Initiated","Letter","Nationwide and Canada","D-820-2013","Class II","AmBisome (amphotericin B) liposome for injection, 50mg vial, single use vial, For Intravenous Infusion Only, Rx Only, Marketed by: Astellas Pharma US, Inc., Northbrook, IL 60062, Manufactured by: Gilead Sciences, Inc, San Dimas, CA 91773, NDC: 0469-3051-30.","Lot #: 042267AA, Exp July 2015, 042287AA, 042289AA, 042291AA, Exp Aug 2015. Lot Numbers and Expiry Dates (for Canada distribution). LOT 042269AA, EXP 07/2015, LOT 0422C1AA, EXP 11/2015. ",,"133,550 Vials","Lack of Assurance of Sterility; Astellas Pharma US, Inc. is performing a voluntary recall on certain lots of AmBisome because the manufacturer has notified Astellas that during a routine simulation of the manufacturing of AmBisome, a bacterial contamination was detected in the media fills.",6/19/2013,"06/19/2013",7/31/2013,"07/31/2013"
"Food",65497,"Ongoing","Terrafina","Bronx","NY","US","Voluntary: Firm Initiated","Telephone","NY, NJ, FL","F-1792-2013","Class I","1) terrafina Natural Roasted Unsalted Pistachios, Net wt. 10 oz (283g) UPC 847938103201, 2) terrafina Natural California Unsalted Pistachios, Net wt. 13 oz (368g) UPC 847938063208, 3) terrafina Natural California Unsalted Pistachios, Net wt. 18 oz (510g) UPC 847938032051, 4) terrafina Natural California Unsalted Pistachios, Net wt. 20 oz (567 g) UPC 847938073207, 5) terrafina Natural California Unsalted Pistachios, Net wt. 7 oz (198g) UPC 847938003204. ","Item numbers: 1) 9320 with Best before 7/1/2013 to 1/31/14, 2) S320 with Best before 7/1/2013 to 1/31/14, 3) M320 with Best before 7/1/2013 to 1/31/14, 4) L320 with Best before 7/1/2013 to 1/31/14, 5) R320 with Best before 7/1/2013 to 1/31/14",".","5250 pounds","Potential Salmonella contamination.",6/7/2013,"06/07/2013",9/11/2013,"09/11/2013"
"Food",65497,"Ongoing","Terrafina","Bronx","NY","US","Voluntary: Firm Initiated","Telephone","NY, NJ, FL","F-1791-2013","Class I","1) terrafina Natural Roasted Salted Pistachios, Net wt. 2.25 oz(63g) UPC 847938032112, 2) terrafina Natural Roasted Salted Pistachios, Net wt. 10 oz (283g) UPC 8497938103218, 3) terrafina Natural California Salted Pistachios, Net wt. 13 oz (368g) UPC 847938063215, 4) terrafina Natural California Salted Pistachios, Net wt. 18 oz (510 g) UPC 847938032150, 5) terrafina Natural California Salted Pistachios, Net wt. 20 oz (568g) UPC 847938073214), 6) terrafina Natural Roasted Salted Pistachios, Net wt. 7 oz (198g) UPC 847938003211.","Item numbers: 1) 3211 with Best before 10/1/2013 to 11/30/13, 2) 9321 with Best before 10/1/2013 to 11/30/13, 3) S321 with Best before 10/1/2013 to 11/30/13, 4) M321 with Best before 10/1/2013 to 11/30/13, 5) L321 with Best before 10/1/2013 to 11/30/13, 6) R321 with Best before 10/1/2013 to 11/30/13 ",".","3500 pounds","Potential Salmonella contamination.",6/7/2013,"06/07/2013",9/11/2013,"09/11/2013"
"Devices",65498,"Ongoing","Accelerated Care Plus Corporation","Reno","NV","US","Voluntary: Firm Initiated","Letter","Nationwide Distribution.","Z-1837-2013","Class II","Omnicycle Elite; US Importer and Distributor: Accelerated Care Plus, Reno NV. Manufactured by Medica Medizintechnik GmbH, Hochdorf, Germany. The product is indicated for powered exercise equipment intended for medical purposes.","Model number A000-533: Serial numbers: 1034-000-00-09033104 1034-000-00-09033107 1034-000-00-09033108 1034-000-00-09033119 1034-000-00-09033120 1034-000-00-09033121 1034-000-00-09033122 1034-000-00-09033132 1034-000-01-09073002 1034-000-01-09073005 1034-000-01-09073018 1034-000-01-09073021 1034-000-01-09073030 1034-000-01-09073123 1034-000-01-09073129 1034-000-01-09073130 1034-000-01-09073134 1034-000-01-09073136 1034-000-01-09073142 1034-000-01-09073146 1034-000-01-09073147 1034-000-01-09090034 1034-000-01-09101119 1034-000-01-09101126 1034-000-01-09101127 1034-000-01-09102107 1034-000-01-09104132 1034-000-01-09105032 1034-000-01-09105039 1034-000-01-09152114 1034-000-01-09152117 1034-000-01-09152120 1034-000-01-09152131 1034-000-01-09162027 1034-000-01-09162034 1034-000-01-09163094 1034-000-01-09163101 1034-000-01-09164098 1034-000-01-09164101 1034-000-01-09164114 1034-000-01-09171128 1034-000-01-09172011 1034-000-01-09172020 1034-000-01-09172021 1034-000-01-09172026 1034-000-01-09172028 1034-000-01-09172035 1034-000-01-09172041 1034-000-01-09172042 1034-000-01-09172046 1034-000-01-09172049 1034-000-01-09172053 1034-000-01-09172060 1034-000-01-09172064 1034-000-01-09172066 1034-000-01-09172070 1034-000-01-09172074 1034-000-01-09172083 1034-000-01-09201007 1034-000-01-09201105 1034-000-01-09201113 1034-000-01-09201118 1034-000-01-09201124 1034-000-01-09201125 1034-000-01-09201133 1034-000-01-09201135 1034-000-01-09201138 1034-000-01-09201139 1034-000-01-09261004 1034-000-01-09261006 1034-000-01-09261008 1034-000-01-09261009 1034-000-01-09261011 1034-000-01-09261017 1034-000-01-09261019 1034-000-01-09261033 1034-000-01-09261048 1034-000-01-09261060 1034-000-01-09261067 1034-000-01-09261077 1034-000-01-09261081 1034-000-01-09261090 1034-000-01-09261092 1034-000-01-09294043 1034-000-01-09294051 1034-000-01-09294052 1034-000-01-09294057 1034-000-01-09294059 1034-000-01-09294071 1034-000-01-09294072 1034-000-01-09294075 1034-000-01-09294078 1034-000-01-09294079 1034-000-01-09294087 1034-000-01-09294098 1034-000-01",,"1001 units","An anomaly in the firmware that may cause Omnicycle Elite to operate at a speed other than what was previously set when in reverse mode.",6/12/2013,"06/12/2013",8/7/2013,"08/07/2013"
"Food",65499,"Ongoing","El Campestre","Compton","CA","US","Voluntary: Firm Initiated","E-Mail","CA","F-1760-2013","Class I","El Campestre Brand Ceviche Mixto, 2/5 lbs bulk containers into 1/10lbs carton. Packaged in 2/5lbs white plastic buckets with lid and handle, into 1/10lbs carton. Labeling reads in part:''CEVICHE MIXTO***NET WT..10 LBS***DIST.BY EL CAMPESTRE DIST TEL (562) 505-7247***''.","Product is not coded with lot numbers. Expiration date 06/01/13",,"35","El Campestre initiated this recall due to the following reason: undeclared allergens: eggs, soy, wheat, and crab extract.",6/13/2013,"06/13/2013",8/7/2013,"08/07/2013"
"Food",65499,"Ongoing","El Campestre","Compton","CA","US","Voluntary: Firm Initiated","E-Mail","CA","F-1762-2013","Class III","El Campestre Brand Ceviche De Basa. Packaged in 2/5lbs white plastic buckets with lid and handle, into 1/10lbs carton. Labeling reads in part:''EL CAMPESTRE CEVICHE DE BASA***NET WT.10 LBS***Manufactured by: El Campestre Compton, CA 90221 (310) 764-2461***''.","Product is not coded with lot numbers. Expiration date 06/01/13",,"259","El Campestre initiated this recall due to the following reason: mislabeling: does not contain Basa fish, it contains Swai fish. ",6/13/2013,"06/13/2013",8/7/2013,"08/07/2013"
"Food",65499,"Ongoing","El Campestre","Compton","CA","US","Voluntary: Firm Initiated","E-Mail","CA","F-1764-2013","Class II","El Campestre Brand Ceviche De Camaron. Packaged in 2/5lbs white plastic buckets with lid and handle, into 1/10lbs carton. Labeling reads in part:''EL CAMPESTRE CEVICHE DE CAMARON***NET WT.10 LBS***Manufactured by: El Campestre Compton, CA 90221 (310) 764-2461***''.","Product is not coded with lot numbers. Expiration date 06/01/13",,,"El Campestre initiated this recall due to the following reason: mislabeling: Shrimp not listed in English, but the whole shrimp are visible.",6/13/2013,"06/13/2013",8/7/2013,"08/07/2013"
"Food",65499,"Ongoing","El Campestre","Compton","CA","US","Voluntary: Firm Initiated","E-Mail","CA","F-1765-2013","Class II","El Campestre Brand Camaron Aquachile. Packaged in 2/5lbs white plastic buckets with lid and handle, into 1/10lbs carton. Labeling reads in part:''EL CAMPESTRE CAMARON AGUACHILE***NET WT.10 LBS***Manufactured by: El Campestre Compton, CA 90221 (310) 764-2461***''.","Product is not coded with lot numbers. Expiration date 06/01/13",,"37","El Campestre initiated this recall due to the following reason: shrimp are not listed in English, but the whole shrimp are visible. ",6/13/2013,"06/13/2013",8/7/2013,"08/07/2013"
"Food",65499,"Ongoing","El Campestre","Compton","CA","US","Voluntary: Firm Initiated","E-Mail","CA","F-1763-2013","Class I","El Campestre Brand Ceviche Mixto De Basa. Packaged in 2/5lbs white plastic buckets with lid and handle, into 1/10lbs carton. Labeling reads in part:''EL CAMPESTRE CEVICHE MIXTO DE BASA***NET WT.10 LBS***Manufactured by: El Campestre Compton, CA 90221 (310) 764-2461***''.","Product is not coded with lot numbers. Expiration date 06/01/13",,"117","El Campestre initiated this recall due to the following reason: undeclared allergens: eggs, soy, wheat, and crab extract.",6/13/2013,"06/13/2013",8/7/2013,"08/07/2013"
"Food",65499,"Ongoing","El Campestre","Compton","CA","US","Voluntary: Firm Initiated","E-Mail","CA","F-1761-2013","Class I","El Campestre Brand Seafood Ranchero. Packaged in 2/5lbs white plastic buckets with lid and handle, into 1/10lbs carton. Labeling reads in part:''SEA FOOD RANCHERO***NET WT..10 LBS***DIST.BY EL CAMPESTRE DIST TEL (562) 505-7247***''.","Product is not coded with lot numbers. Expiration date 06/01/13",,"45","El Campestre initiated this recall due to the following reason: undeclared allergens: eggs, soy, wheat, and crab extract. ",6/13/2013,"06/13/2013",8/7/2013,"08/07/2013"
"Food",65500,"Ongoing","Taylor Farms New Jersey, NJ","Swedesboro","NJ","US","Voluntary: Firm Initiated","E-Mail","New Jersey, Pennsylvania, Delaware, Virginia, and Maryland","F-1574-2013","Class I","Wawa Black Forest Ham and Cheese on a Pretzel Roll with swiss cheese and country dijon honey mustard. Net Wt. 8.7 oz (247g). Distributed by Wawa, Inc., Wawa, PA 19063.","sell by 06/23/13 TFNJ 170 5:00am.",,"520 units","Taylor Farms New Jersey, Inc. of Swedesboro, NJ is voluntarily recalling a limited quantity of Black Forest Ham and Cheese on a Pretzel Roll with swiss cheese and country dijon honey mustard because they have the potential of containing an undeclared tree nut allergen. ",6/20/2013,"06/20/2013",7/3/2013,"07/03/2013"
"Drugs",65501,"Ongoing","Sun Pharmaceutical Industries Inc.","Cranbury","NJ","US","Voluntary: Firm Initiated","Letter","Nationwide and Puerto Rico","D-687-2013","Class II","Nimodipine Capsules 30 mg, Rx Only, For Institutional Use Only, a) 30-count unit dose Capsules (5x6 blister cards per carton), NDC 57664-135-64, b) 100-count unit dose Capsules (25x4 blister cards per carton), NDC 57664-135-65, Distributed by: Caraco Pharmaceutical Laboratories, Ltd. Detroit, MI 48202 Affiliate of Sun Pharmaceutical Industries, Inc. ","Lot #s: a) 3305.036B, 3305.037B, Exp Jun-13; 3505.041B, Exp Sep-13; 3305.043B, Exp Nov-13; 3305.044B, Exp Dec-13; 3305.045B Mar-14. Lot #s: b) 3305.036A, 3305.037A, Exp Jun-13; 3305.038A, Exp Jul-13; 3305.040A, 3505.041A Exp Sep-13; 3305.042A, 3305.043A, Exp Nov-13; 3305.044A Dec-13.",".","46387 Cartons","Crystallization; crystallized nimopdipine",5/21/2013,"05/21/2013",7/17/2013,"07/17/2013"
"Devices",65502,"Ongoing","Zimmer, Inc.","Warsaw","IN","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution - USA (nationwide) and internationally to Australia, Austria, Belgium, Brazil, Canada, China, Czech Republic, Denmark, Finland, France, Germany, Greece, India, Israel, Italy, Korea, Lebanon, Malta, Netherlands, Norway, Portugal, Singapore, Spain, Sweden, Switzerland, Taiwan, Thailand, United Kingdom, Utd.Arab.Emir.","Z-1954-2013","Class II","REF 00-4309-071-40 Trabecular Metal Reverse Shoulder System Instrumentation, Glenosphere Helmet, 40 mm Diameter Nonsterile, Qty -1 Instrumentation used in shoulder replacement surgery. The glenosphere helmet is used to insert the glenosphere onto the base plate prior to impaction with the glenospere impactor.","60720060 60729529 60782351 60875299 60902349 60948238 60943023 60985367 61019824 61034822 61063216 61145917 61183670 61207699 61218854 61356595 61400936 61515555 61566478 61615548 61756075 61780197 61832594 61864229 61923988 61978214 62041752 62136099 62180444 62226761 and 62289420 ",,"3,163 both sizes","There is potential for one or both tabsof theTrabecular Metal Reverse Glenosphere Helmet to fracture during use and become disassociated from the device. There have been 47 reported complaints of tab fracture.",6/28/2013,"06/28/2013",8/21/2013,"08/21/2013"
"Devices",65502,"Ongoing","Zimmer, Inc.","Warsaw","IN","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution - USA (nationwide) and internationally to Australia, Austria, Belgium, Brazil, Canada, China, Czech Republic, Denmark, Finland, France, Germany, Greece, India, Israel, Italy, Korea, Lebanon, Malta, Netherlands, Norway, Portugal, Singapore, Spain, Sweden, Switzerland, Taiwan, Thailand, United Kingdom, Utd.Arab.Emir.","Z-1953-2013","Class II","REF 00-4309-071-36 Trabecular Metal Reverse Shoulder System Instrumentation, Glenosphere Helmet, 36 mm Diameter Nonsterile, Qty -1 Instrumentation used in shoulder replacement surgery. The glenosphere helmet is used to insert the glenosphere onto the base plate prior to impaction with the glenospere impactor.","60729528 60720059 60782350 60803204 60811712 60889765 60909408 60943022 60948237 60989841 60985366 61019823 61051119 61034821 61140638 61178017 61207698 61237374 61304005 61338570 61356591 6381187 61400935 61431685 61463330 61487660 61521267 61544005 61585968 61627734 61704564 61735029 61772406 61794587 61817713 61858701 61850103 61877862 61950512 61998686 61972672 62010251 62018071 62041751 62078963 62096387 62121179 62136094 62141873 62158509 62180443 62203390 62215390 62249372 62271566 62298060 ",,"3,163","There is potential for one or both tabsof theTrabecular Metal Reverse Glenosphere Helmet to fracture during use and become disassociated from the device. There have been 47 reported complaints of tab fracture.",6/28/2013,"06/28/2013",8/21/2013,"08/21/2013"
"Devices",65503,"Ongoing","Integra LifeSciences Corp.","Plainsboro","NJ","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Worldwide Distribution-USA (nationwide) including the states of AL, AR, AZ, CA, CO, CT, FL, GA, IA, ID, IL, IN, KY, LA, MA, MD, MI, MN, MO, MT, NC, NE, NJ, NV, NY, OH, PA, RI, SC, TN, TX, UT, VA, and WA and the countries of Canada, Austria, Belgium, Switzerland, Czech Republic, Germany, Denmark, Spain, Finland, France, Ireland, Israel, Italy, Lebanon, Luxembourg, Netherlands, Norway, Portugal, Russia, Saudi Arabia, Sweden, United Arab Republic, United Kingdom, and South Africa.","Z-1685-2013","Class II","Integra Hallu-Fix cannulated screw driver (model number P/N 129733ND) and cannulated screwdriver tip (model number P/N 129735ND). Indicated for use in fixation of fractures, osteotomies and arthrodesis of the first metatarso-phalangeal joint. ","The following lots of the cannulated screw driver (model number P/N 129733ND) were affected: D2ZG, D32L, D3HV, D3PG and E0U3. The following lots of the cannulated screwdriver tip (model number P/N 129735ND) were affected: D2ZQ and D3EC. ",".","154 screwdrivers were distributed; 67 screwdriver tips were distributed. ","The firm has received numerous complaints of the cannulated screw driver tip breaking during surgery. ",2/1/2013,"02/01/2013",7/17/2013,"07/17/2013"
"Devices",65504,"Ongoing","Ethicon Endo-Surgery Inc","Cincinnati","OH","US","Voluntary: Firm Initiated","Letter","Worldwide distribution: US (nationwide) including states of: AK, AL, AR, AZ, CA, CO, CT, FL, GA, lA, ID, IL, IN, KS, KY, LA, MA, MD, ME, Ml, MN, MO, MS, MT, NC, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV, & WY and countries of: Canada, Argentina, Australia, Austria, Bahrain, Belgium, Brazil, Canada, Chile, China, Columbia, Czech Republic, Dominican Republic, Ecuador, Egypt, India, Indonesia, Israel, Italy, Jamaica, Japan, Korea, Kuwait, Libya, Malaysia, Mexico, Pakistan, Panama, Philippines, Poland, Puerto Rico, Russia, Singapore, Slovenia, South Africa, Spain, Saudi Arabia, Taiwan, Thailand, Turkey, United Arab Emirates, United Kingdom, Uruguay, & Venezuela.","Z-1772-2013","Class II","Endopath Electrosurgery Probe Plus II, twelve (12) different devices, including hooks, spatulas, right angles, curved dissectors, suction/irrigation devices, accessory ports, pool/sump devices and stone retrieval cannula, packaged and sterilized individually in a transparent flexible blister sealed to a Tyvek lid. 6 flexible packages are placed into a sales unit carton, with 4 cartons per corrugated shipper. The Endopath Electrosurgery Probe Plus II system has application in minimally invasive procedures to facilitate tissue dissection, coagulation, irrigation, and fluid evacuation through a common trocar sleeve.","Product Code: EPS01, Exp. Date: 2015 09 through 2018 03; Product Code: EPS02, Exp. Date: 2015 09 through 2018 03; Product Code: EPS03, Exp. Date: 2015 09 through 2018 03; Product Code: EPS04, Exp. Date: 2015 09 through 2018 03; Product Code: EPS05, Exp. Date: 2015 09 through 2018 03; Product Code: EPS06, Exp. Date: 2015 09 through 2018 03; Product Code: EPS07, Exp. Date: 2015 09 through 2018 03; Product Code: EPS08, Exp. Date: 2015 09 through 2018 03; Product Code: EPS10, Exp. Date: 2013 04 through 2018 03; Product Code: EPS11, Exp. Date: 2013 04 through 2018 03; Product Code: EPS12, Exp. Date: 2013 04 through 2018 03 & Product Code: EPS13, Exp. Date: 2013 04 through 2018 03.",,"327,648 instruments","The firm is recalling the ENDOPATH Probe Plus II Shafts because the possibility that a tear in the Tyvek packaging may affect the sterility of the device.",4/8/2013,"04/08/2013",7/31/2013,"07/31/2013"
"Devices",65505,"Terminated","Karl Storz Endoscopy America Inc","Southbridge","MA","US","Voluntary: Firm Initiated","Letter","US distribution to: AZ, FL, IL, IN and TX.","Z-1728-2013","Class II","27023WU Balloon Catheter, 3 Fr., 2/pkg, sterile, contains latex. The RUSCH ureter occlusion catheter is indicated for the routine occlusion of the ureter to prevent the movement of stone fragments during treatment. The coaxial catheters will also allow simultaneous drainage of urine or infusion of other solutions.","Lots: 12471, 12281, 12271, 12171, 12101, 12051, 11501, 11401, 09471, 09431, 09251, 09201, 09161, 09091, 09071, 08451. ",".","40 units","Karl Storz Endoscopy-America has initiated the recall of the 27023WU Balloon Catheter because the packaging may be compromised, and therefore the sterility of the product could be affected.",5/31/2013,"05/31/2013",7/24/2013,"07/24/2013"
"Devices",65506,"Ongoing","Biosense Webster, Inc.","Irwindale","CA","US","Voluntary: Firm Initiated","Letter","Distributed in the states of MN, FL, and UT.","Z-1617-2013","Class II","20-Pole LASSO Nav Catheter Eco, Catalog # D-1349-02S. Designed to facilitate electrophysiological mapping of the atria of the heart. ","Lot # 15832314L",".","10 units","Biosense Webster is recalling the 20-Pole LASSO NAV Catheter Eco because it has been incorrectly calibrated causing them to be recognized and displayed as a 10-Pole LASSO NAV Catheter Eco by the CARTO 3 System.",6/19/2013,"06/19/2013",7/10/2013,"07/10/2013"
"Biologics",65507,"Ongoing","Life Technologies Holdings Pte Ltd","Singapore",,"SG","Voluntary: Firm Initiated","Letter","DE,. IL, MA, MN,NE, OR.","B-2151-13","Class III","Applied BioSystems (AB) Hi-Di Formamide, 5 ml used with the Hi-DI Formamide 3500 Dx Series. In-Vitro Diagnostic Part Number: 4404307","Lot Number: 1302029",".","1 Bottle","Injection solvent for use with genetic analyzers, stored in warehouse at improper temperatures, was distributed. ",6/20/2013,"06/20/2013",8/28/2013,"08/28/2013"
"Food",65508,"Ongoing","Garden-Fresh Foods, Inc.","Milwaukee","WI","US","Voluntary: Firm Initiated","Press Release","IA, FL, TX","F-1646-2013","Class II","LID: Archer Fames, Smoked Salmon dip, NET WT 11 OZ (312g). TUB: Archer Farms, Bacon Parmesan dip, NET WT 11 OZ (312g). UPC: 0 85239 99017 9 Distributed by Target corp., Minneapolis, MN.","Lot code: 28 / JUN / 2013 / 01 Best By Date: 28 / JUN / 2013 / 01",".","126 cases ( 6 containers / case) for a total of 756 contaienrs","Garden Fresh Foods Inc. is voluntarily recalling a limited number of packages of Archer Farms Smoked Salmon Dip that may contain undeclared allergens, fish and egg. Some of Archer Farms Smoked Salmon Dip may have inadvertently been filled in a limited amount of Bacon Parmesan dip containers. ",6/19/2013,"06/19/2013",7/17/2013,"07/17/2013"
"Food",65509,"Ongoing","Granna's, LLC","Bessie","OK","US","Voluntary: Firm Initiated","Press Release","All product was distributed in Oklahoma.","F-1595-2013","Class I","Granna's 412 Main, Bessie, Oklahoma 705 Tuna Mac, Italian Blend Vegetables & Spiced Apple Rings","Best By dates of 06/20/2013 to 06/20/2014.",".","26,740 packages","The product was recalled due to undeclared egg.",6/20/2013,"06/20/2013",7/17/2013,"07/17/2013"
"Drugs",65511,"Ongoing","Sandoz Incorporated","Broomfield","CO","US","Voluntary: Firm Initiated","Letter","Distributed to one consignee in Indiana. No foreign, government, VA, or military consignees.","D-805-2013","Class II","Estarylla (Norgestimate and Ethinyl Estradiol) Tablets. USP, 0.25mg/0.035mg, 3X28 tablets per carton. Rx only, Manufactured by Laboratorios Leon Farma S.A. Spain for Sandoz Inc. Princeton, NJ 08540, NDC 0781-4058-15 ","Lot: LF01213A, Exp. 02/14",".","10,848 cartons ","Contraceptive Tablets out of Sequence: A placebo tablet was found in a row of active tablets.",6/21/2013,"06/21/2013",7/24/2013,"07/24/2013"
"Drugs",65512,"Ongoing","Fresenius Kabi USA, LLC","Lake Zurich","IL","US","Voluntary: Firm Initiated","Letter","Nationwide and Puerto Rico","D-804-2013","Class II","Oxytocin Injection, USP, (Synthetic), 10 USP Units/mL, for IV Infusion or IM Use, Rx Only, 1 mL vial, APP ) 10 USP Units/mL, 1 mL, APP Pharmaceuticals, LLC Schaumburg, IL, 60173, NDC 63323-012-01.","Lot #: 6003648, Exp. 6/2013",".","221,600 vials","Subpotent Drug; 15-month stability test station",6/24/2013,"06/24/2013",7/24/2013,"07/24/2013"
"Devices",65513,"Ongoing","Zimmer, Inc.","Warsaw","IN","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Worldwide distribution: US Nationwide (including PR and USVI), and countries of: Israel, Argentina, Brazil, France, Mexico, Saudi Arabia, Beirut, China, Korea, San Salvador, Honduras, Canada, Australia, Switzerland, Germany, Arab Emirates, UK, Belgium, Egypt, Spain, France, Italy, Iran, Lebanon, Jordan, Iraq, Canary Islands.","Z-2093-2013","Class II","VERSA-FX II FEMORAL FIXATION SYSTEM COMPRESSION TUBE/PLATE, standard and short low profiles, several holes/length combinations (2/54, 3/70, 4/86, 5/102, 6/118) and several angles (130, 135, 140, 145 and 150). Item codes starting with 00-1193-130, 00-1193-135, 00-1193-140, 00-1193-145, 00-1193-150. Orthopedic implant.","60611022 60611024 60619085 60598271 60598275 60628437 60582010 60625420 60629729 60630044 60630089 60632485 60628439 60630043 60630090 60630091 60630093 60630095 60630098 60632496 60632513 60629728 60630092 60630094 60630096 60632497 60632504 60632506 60646243 60632516 60632527 60646247 60632505 60632514 60646241 60646245 60646256 60648988 60648990 60630045 60646250 60646257 60646260 60646261 60630097 60646251 60664579 60666551 60666553 60630101 60664586 60664589 60664591 60666539 60666552 60666554 60664584 60666570 60646255 60664594 60666550 60666568 60666555 60666557 60666567 60666540 60666544 60666546 60666547 60666548 60664611 60666569 60664616 60666542 60666543 60666556 60666560 60679361 60679362 60679363 60666545 60678765 60678768 60678771 60679351 60679353 60679364 60679345 60679348 60679359 60685057 60666558 60666561 60679349 60679354 60679357 60685086 60685089 60679352 60679360 60666541 60674432 60685033 60685035 60685036 60685038 60685060 60685081 60679355 60685083 60685031 60685072 60699482 60685030 60699487 60699488 60704350 60704351 60704355 60704352 60699489 60704353 60704346 60704354 60704345 60704347 60704348 60704357 60704358 60704360 60714919 60704349 60704359 60685034 60704356 60704361 60704363 60714925 60714920 60714928 60714922 60714924 60704362 60704364 60704365 60714918 60714923 60714926 60714927 60714932 60714934 60714935 60714936 60714965 60714966 60714967 60714968 60726367 60714933 60726368 60726329 60726365 60674435 60726330 60726332 60726364 60726324 60726327 60726328 60726366 60746152 60726320 60726331 60726369 60746137 60746188 60746189 60746190 60746266 60746268 60726321 60746183 60746280 60754394 60726322 60726323 60726370 60746134 60746269 60746273 60746265 60746193 60746270 60763198 60746271 60699490 60726361 60746151 60763201 60763202 60763203 60763204 60763213 60746281 60763199 60763212 60746186 60746267 60746274 60763210 60746185 60746191 60746272 60763197 60763205 60763206 60699483 60746153 60763211 60746184 60763196 60779869 60779870 60779871 60779873 60779874 60779875 60",,"85, 794 units in total","Single packaging configuration used for the VERSA-FX-II Femoral Fixation System failed the leak test compromising the sterility of the product.",6/19/2013,"06/19/2013",9/4/2013,"09/04/2013"
"Devices",65513,"Ongoing","Zimmer, Inc.","Warsaw","IN","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Worldwide distribution: US Nationwide (including PR and USVI), and countries of: Israel, Argentina, Brazil, France, Mexico, Saudi Arabia, Beirut, China, Korea, San Salvador, Honduras, Canada, Australia, Switzerland, Germany, Arab Emirates, UK, Belgium, Egypt, Spain, France, Italy, Iran, Lebanon, Jordan, Iraq, Canary Islands.","Z-2092-2013","Class II","VERSA-FX FEMORAL FIXATION SYSTEM COMPRESSION LAG SCREW, several length (55 mm to 155 mm), diameters (12.7 mm and 15.8 mm) and short thread, standard thread and large thread. Item codes starting with 00-1193-005, 00-1193-010 and 00-1193-015. Versa-Fx Femoral Fixation System, orthopedic implant.","60550146 60585234 60585240 60621358 60612822 60585235 60612824 60585239 60629949 60629951 60573157 60612823 60612832 60629948 60629756 60629755 60629950 60560744 60621346 60621347 60621348 60621350 60612826 60621349 60621351 60621353 60585244 60612820 60612830 60621354 60621356 60621357 60612825 60612829 60612831 60653083 60653092 60653075 60653078 60653085 60653088 60653100 60653111 60539408 60539409 60653095 60653098 60653107 60653110 60653114 60653116 60653115 60653121 60671979 60671980 60653146 60671982 60561143 60653108 60653109 60653119 60653123 60653124 60653125 60653130 60653134 60653135 60653136 60653139 60653143 60653104 60653118 60653127 60682963 60671976 60653117 60653129 60653132 60661882 60671959 60671977 60671962 60671967 60653142 60621355 60653141 60671965 60671963 60671964 60523364 60612818 60653131 60671961 60615110 60653133 60653140 60536820 60671970 60671978 60671969 60671971 60671972 60671975 60671981 60690731 60653122 60671960 60680440 60653145 60653147 60671973 60671983 60680441 60690733 60702010 60705050 60671966 60671974 60702013 60702012 60702014 60702017 60621352 60671968 60702015 60523382 60690730 60690732 60702019 60702021 60702029 60702037 60705049 60702011 60702016 60702023 60690734 60702018 60702025 60539410 60714821 60714822 60714827 60702031 60727241 60671984 60442552 60714814 60714815 60539411 60714813 60714816 60714817 60714818 60714819 60714825 60733781 60539412 60714820 60736759 60736761 60714826 60721965 60736760 60539407 60714823 60747379 60736763 60736768 60736765 60736769 60736764 60736767 60782054 60782058 60781220 60782055 60782056 60782057 60736772 60781214 60782065 60781216 60781218 60782060 60782067 60782063 60782069 60782064 60782066 60782059 60794238 60782062 60736766 60781215 60782068 60794237 60736770 60736771 60799737 60736773 60736774 60736775 60736776 60781221 60794263 60736777 60781222 60782061 60799738 60799741 60794244 60799739 60799740 60781219 60812161 60817012 60812151 60812152 60812156 60812149 60794245 60812150 60812153 60812154 60812155 60812157 60",,"85, 794 units in total","Single packaging configuration used for the VERSA-FX-II Femoral Fixation System failed the leak test compromising the sterility of the product.",6/19/2013,"06/19/2013",9/4/2013,"09/04/2013"
"Devices",65513,"Ongoing","Zimmer, Inc.","Warsaw","IN","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Worldwide distribution: US Nationwide (including PR and USVI), and countries of: Israel, Argentina, Brazil, France, Mexico, Saudi Arabia, Beirut, China, Korea, San Salvador, Honduras, Canada, Australia, Switzerland, Germany, Arab Emirates, UK, Belgium, Egypt, Spain, France, Italy, Iran, Lebanon, Jordan, Iraq, Canary Islands.","Z-2091-2013","Class II","Free Lock Femoral Hip Fixation System Compression Tube/Plate, different length (59, 75, 91, 107, 123 mm), holes (2, 3, 4, 5, 6) and degree angles (130, 135, 140, 145 and 150). Item codes starting with 00-1181-130, 00-1181-135, 00-1181-140, 00-1181-145, 00-1181-150). ZIMMER Compression Hip Screw, orthopedic implant.","60611049 60624520 60619105 60619109 60624518 60624519 60625544 60619107 60619879 60611045 60624521 60625511 60625536 60625542 60582204 60619887 60657047 60646266 60657046 60657070 60657071 60657072 60632725 60657051 60657073 60657083 60657075 60657078 60657088 60625545 60646267 60657049 60657052 60657077 60657079 60657087 60657084 60668304 60668305 60582089 60674430 60674431 60685115 60714886 60714872 60714893 60714875 60714897 60714851 60714890 60714892 60714850 60714877 60714896 60714891 60714894 60763218 60763232 60763219 60763220 60763221 60763226 60763230 60763234 60763223 60763227 60763229 60763222 60763224 60763225 60763231 60763233 60714895 60763228 60803587 60803589 60803591 60803592 60803593 60807853 60807854 60803588 60803590 60807855 60803586 60807868 60815019 60820809 60841203 60820796 60807857 60820798 60820801 60807858 60807859 60807861 60807856 60815017 60807865 60820810 60820807 60868474 60868478 60874089 60874093 60874097 60877491 60868477 60885177 60885178 60885180 60885182 60885175 60885179 60885185 60885184 60902841 60905697 60902842 60902843 60911345 60911346 60911348 60911350 60931165 60931166 60911349 60931164 60938423 60944574 60931167 60931168 60944606 60932394 60944525 60938427 60944551 60968742 60959978 60969382 60972805 60972806 60968739 60968744 60988403 60988405 60962160 60988402 60988407 60988408 60988404 60998291 60998292 61020344 61030741 61020343 61030740 61037492 61030742 61037493 61037494 61048120 61048117 61048116 61048119 61048115 61048121 61027553 61048118 61027552 61076085 61076086 61086854 61086857 61079836 61079834 61092273 61092280 61101553 61092247 61092249 61092258 61092281 61092283 61101552 61101554 61103203 61103208 61101551 61103202 61103204 61103206 61103207 61108242 61108243 61108244 61115872 61114143 61118976 61140178 61162614 61162616 61162617 61162615 611694",,"85, 794 units in total","Single packaging configuration used for the VERSA-FX-II Femoral Fixation System failed the leak test compromising the sterility of the product.",6/19/2013,"06/19/2013",9/4/2013,"09/04/2013"
"Devices",65513,"Ongoing","Zimmer, Inc.","Warsaw","IN","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Worldwide distribution: US Nationwide (including PR and USVI), and countries of: Israel, Argentina, Brazil, France, Mexico, Saudi Arabia, Beirut, China, Korea, San Salvador, Honduras, Canada, Australia, Switzerland, Germany, Arab Emirates, UK, Belgium, Egypt, Spain, France, Italy, Iran, Lebanon, Jordan, Iraq, Canary Islands.","Z-2090-2013","Class II","Free Lock Femoral Hip Fixation System Compression Lag Screw . Several lengths (55 to 150 mm) and diameters (12.7 and 15. 8 mm). Item codes starting with 00-1181-05, 00-1181-10 and 00-1181-15. ZIMMER Compression Hip Screw, orthopedic implant.","60621340 60621339 60621342 60621345 60639475 60621341 60621338 60621344 60671954 60653031 60653066 60671958 60639474 60653032 60653043 60653053 60653063 60671956 60671957 60705048 60653057 60653069 60671955 60621343 60705047 60714810 60705044 60701995 60705045 60701998 60702002 60705043 60702006 60680439 60736748 60781210 60781213 60781212 60781211 60782044 60782047 60782049 60705046 60714808 60782048 60782043 60782050 60736749 60714809 60736750 60782046 60736752 60736753 60736756 60782040 60782045 60736754 60781209 60782041 60812142 60812145 60782037 60812143 60812147 60815943 60564710 60812146 60817011 60782042 60812141 60812144 60812148 60815946 60830649 60830650 60830670 60830652 60572991 60736755 60736758 60862361 60862362 60862363 60862364 60862365 60862366 60862367 60879681 60862369 60879678 60862368 60564708 60915347 60931209 60931208 60931211 60931212 60931213 60931215 60973693 60973694 61026401 61026409 61026399 61026402 61026406 61026414 61026415 61026405 61026403 61026407 61026404 61045321 61026411 61037587 61037589 61037588 61037586 61037590 61037591 61063230 61069128 61063232 61069129 61069131 61069132 61077253 61083091 61083092 61083093 61077251 61108038 61110037 61110038 61114907 60879682 61120993 61120992 61141516 61141512 61141515 61141517 61142760 61141513 61141514 61142759 61142761 61142762 61171562 61171564 61171565 61184407 61184409 61184410 61141518 61142763 61179647 61184408 61195103 61184405 61184406 61195101 61195104 61195097 61195095 61195096 61195102 61195094 61195099 61195098 61209057 61275454 61251129 61251131 61209056 61209053 61275452 61278174 61278175 61278176 61284325 61284326 61284327 61284328 61286932 61274845 61209054 61209055 61251130 61278171 61284322 61284324 61286935 61286938 61286940 61195093 61278172 61278173 61275456 61268917 61278177 61399023 61310083 61345993 613933",,"85, 794 units in total","Single packaging configuration used for the VERSA-FX-II Femoral Fixation System failed the leak test compromising the sterility of the product.",6/19/2013,"06/19/2013",9/4/2013,"09/04/2013"
"Devices",65513,"Ongoing","Zimmer, Inc.","Warsaw","IN","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Worldwide distribution: US Nationwide (including PR and USVI), and countries of: Israel, Argentina, Brazil, France, Mexico, Saudi Arabia, Beirut, China, Korea, San Salvador, Honduras, Canada, Australia, Switzerland, Germany, Arab Emirates, UK, Belgium, Egypt, Spain, France, Italy, Iran, Lebanon, Jordan, Iraq, Canary Islands.","Z-2094-2013","Class II","VERSA-FX II FEMORAL FIXATION SYSTEM COMPRESSION TUBE/PLATE, standard and short - low profile, different hole/length combinations (4/86, 5/102 and 6/118), different degree angles (130, 135, 140, 145 and 150). Item codes starting with 00-194-130, 00-1194-135, 00-1194-140, 00-1194-145, 00-1194-150). Orthopedic implant.","60619089 60619099 60611043 60619098 60611039 60632532 60668205 60668241 60669598 60668240 60668247 60685095 60685102 60679344 60685066 60685104 60685096 60674425 60704366 60704367 60704370 60714913 60704368 60714914 60714915 60714916 60726325 60744850 60714917 60726326 60754395 60763214 60763215 60763216 60787010 60787191 60787194 60787198 60787190 60787192 60787193 60787196 60787199 60787197 60787189 60803585 60807846 60807848 60803584 60787195 60815493 60845778 60845777 60844062 60868471 60877490 60877489 60885169 60885171 60911343 60932392 60932393 60938417 60938419 60943339 60938421 60944523 60787188 60972802 60972803 60998290 61005007 60972801 61020337 61020339 61020335 61037487 61037488 61037489 61041090 61037490 61027502 61027507 61027516 61041091 61027510 61027523 61027511 60868468 61076083 61086851 61041093 61092223 61092239 61092241 61103196 61103197 61103198 61103201 61101549 61103199 61101547 61041089 61140177 61162619 61162620 61169415 61169416 61169417 61179752 61169418 61198454 61223003 61162621 61092237 61228339 61264745 61264742 61264746 61294830 61286877 61304472 61286880 61309349 61309350 61286879 61341982 61341983 61357166 61357172 61357171 61359993 61286878 61446407 61456386 61375171 61458224 61459335 61474332 61464382 61476801 61476802 61476803 61427113 61427114 61475572 61427115 61474333 61474334 61482163 61482164 61453113 61493898 61511595 61516366 61516367 61523581 61542781 61538715 61542606 61551564 61565482 61565483 61584968 61578708 61596986 61613171 61590988 61596985 61619259 61631410 61631417 61631426 61619260 61640888 61635177 61640895 61640889 61640890 61672132 61672134 61640891 61672127 61708338 61708350 61714083 61729213 61748334 61749017 61749009 61749012 61749027 61758148 61804344 61861311 62105419 62271938 62271936 62271934 62310747 ",,"85, 794 units in total","Single packaging configuration used for the VERSA-FX-II Femoral Fixation System failed the leak test compromising the sterility of the product.",6/19/2013,"06/19/2013",9/4/2013,"09/04/2013"
"Drugs",65515,"Ongoing","Teva Pharmaceuticals USA, Inc.","Sellersville","PA","US","Voluntary: Firm Initiated","Letter","Nationwide","D-847-2013","Class II","Methylphenidate Hydrochloride Extended-Release Capsules (LA), 20 mg, 100 count bottle, Rx only, TEVA PHARMACEUTICALS USA, NDC 0093-5346-01","34010282A, 34010283A, 34010284A, 34010285A, 34010286A and 34010565A, exp 04/14; 34013199A, 34013200A, 34013201A, 34013202A and 34013203A, exp 10/14. ",".","16,293 bottles","Failed Dissolution Specifications: Product is being recalled due to out of specification dissolution results obtained during routine stability testing.",6/18/2013,"06/18/2013",8/14/2013,"08/14/2013"
"Drugs",65515,"Ongoing","Teva Pharmaceuticals USA, Inc.","Sellersville","PA","US","Voluntary: Firm Initiated","Letter","Nationwide","D-848-2013","Class II","Methylphenidate Hydrochloride Extended-Release Capsules (LA), 30 mg, 100 count bottle, Rx only, TEVA PHARMACEUTICALS USA, NDC 0093-5347-01","34010290A, 34010291A, 34010292A, exp 04/14, 34011855A, 34011856A, 34011857A, 34011858A, 34013216A, 34013217A, 34013218A, exp 06/14. ",".","13,478 bottles","Failed Dissolution Specifications: Product is being recalled due to out of specification dissolution results obtained during routine stability testing.",6/18/2013,"06/18/2013",8/14/2013,"08/14/2013"
"Drugs",65515,"Ongoing","Teva Pharmaceuticals USA, Inc.","Sellersville","PA","US","Voluntary: Firm Initiated","Letter","Nationwide","D-849-2013","Class II","Methylphenidate Hydrochloride Extended-Release Capsules (LA), 40 mg, 100 count bottle, Rx only, TEVA PHARMACEUTICALS USA, NDC 0093-5348-01","34010287A, 34010288A, 34010289A, exp 4/2014; 34011513A, 34011514A, and 34011515A, exp 06/14.",".","7,579 bottles","Failed Dissolution Specifications: Product is being recalled due to out of specification dissolution results obtained during routine stability testing.",6/18/2013,"06/18/2013",8/14/2013,"08/14/2013"
"Drugs",65516,"Ongoing","Teva Pharmaceuticals USA, Inc.","Sellersville","PA","US","Voluntary: Firm Initiated","Letter","Nationwide","D-803-2013","Class III","Amoxicillin for Oral Suspension, USP 200 mg/5 mL, a) 75 mL bottle NDC 0093-4160-78 and b) 100 mL bottle NDC 0093-4160-73, Rx Only, Manufactured in Canada by: Teva Canada Limited, Toronto, Canada M1B2K9, Manufactured for: Teva Pharmaceuticals USA, Sellersville, PA 18960.","Lot #s: a) 35426557A, 35426558A, Exp 08/14; b) 35426554A, 35426555A, 35426556A, Exp 08/14",".","109,080 Bottles","Discoloration: This recall is being carried out due to an orange to brown discolored Amoxicillin powder on the inner foil seal of the bottles. This is an expansion of RES 65050.",6/18/2013,"06/18/2013",7/24/2013,"07/24/2013"
"Biologics",65517,"Terminated","Eye Bank Of Wisconsin, Inc.","Madison","WI","US","Voluntary: Firm Initiated","Telephone","Wisconsin; West Virginia","B-2272-13","Class III","Cornea","CW101654OD; CW101654OS",".","2 corneas","Human Corneas, recovered from a donor whose plasma dilution was not properly evaluated, were distributed. ",6/13/2013,"06/13/2013",9/11/2013,"09/11/2013"
"Biologics",65518,"Terminated","Community Blood Bank of Lancaster County Medical Society","Lincoln","NE","US","Voluntary: Firm Initiated","FAX","Pennsylvania; Nebraska; California","B-2221-13","Class II","Fresh Frozen Plasma","W087912651563; W087912605484; ",".","2","Blood products, collected from a donor considered to be at increased risk for variant Creutzfeldt-Jakob Disease (vCJD), were distributed. ",5/14/2013,"05/14/2013",9/18/2013,"09/18/2013"
"Biologics",65518,"Terminated","Community Blood Bank of Lancaster County Medical Society","Lincoln","NE","US","Voluntary: Firm Initiated","FAX","Pennsylvania; Nebraska; California","B-2220-13","Class II","Fresh Frozen Plasma","W087912651563; W087912605484; ",".","2","Blood products, collected from a donor considered to be at increased risk for variant Creutzfeldt-Jakob Disease (vCJD), were distributed. ",5/14/2013,"05/14/2013",9/18/2013,"09/18/2013"
"Biologics",65520,"Terminated","The American National Red Cross South Carolina Region","Columbia","SC","US","Voluntary: Firm Initiated","Other","Alabama","B-2222-13","Class III","Blood and Blood Products for Reprocessing","036GW30440; ",".","1","Blood product, collected from a donor for whom donor suitability was not adequately determined, was distributed.",5/12/2013,"05/12/2013",9/18/2013,"09/18/2013"
"Biologics",65521,"Terminated","International Sight Restoration, Inc.","Tampa","FL","US","Voluntary: Firm Initiated","E-Mail","Egypt; Lebanon; Argentina; Mexico; Romania; South Africa; Iraq","B-2281-13","Class III","Cornea","20130020OD; 20130020OS; 20130040OD; 20130040OS; 20130040ODSW; 20130040OSSW; 20130073OD; 20130073OS; 20130077OD; 20130077OS",".","10 corneas","Human corneas, recovered from donors whose donor eligibility determination failed to ensure that the donor was free from risk factors for, and clinical evidence of infection due to relevant communicable disease agents and diseases, were distributed. ",6/5/2013,"06/05/2013",9/11/2013,"09/11/2013"
"Biologics",65521,"Terminated","International Sight Restoration, Inc.","Tampa","FL","US","Voluntary: Firm Initiated","E-Mail","Egypt; Lebanon; Argentina; Mexico; Romania; South Africa; Iraq","B-2282-13","Class II","Cornea","20120136OD; 20120136OS",".","2 corneas","Human corneas, recovered from donors whose donor eligibility determination failed to ensure that the donor was free from risk factors for, and clinical evidence of infection due to relevant communicable disease agents and diseases, were distributed. ",6/5/2013,"06/05/2013",9/11/2013,"09/11/2013"
"Biologics",65522,"Terminated","OneBlood, Inc.","Lantana","FL","US","Voluntary: Firm Initiated","Letter","Florida","B-2234-13","Class II","Platelets Pooled Leukocytes Reduced Irradiated","2909013; ",".","1","Blood products, collected from a donor in whom donor suitability was not adequately determined, were distributed.",5/28/2013,"05/28/2013",9/18/2013,"09/18/2013"
"Biologics",65522,"Terminated","OneBlood, Inc.","Lantana","FL","US","Voluntary: Firm Initiated","Letter","Florida","B-2233-13","Class II","Red Blood Cells Leukocytes Reduced","2388428; ",".","1","Blood products, collected from a donor in whom donor suitability was not adequately determined, were distributed.",5/28/2013,"05/28/2013",9/18/2013,"09/18/2013"
"Biologics",65523,"Terminated","Houchin Blood Services","Bakersfield","CA","US","Voluntary: Firm Initiated","Telephone","California","B-2235-13","Class III","Red Blood Cells Leukocytes Reduced","W224312328079; W224312328026; W224312328027; W224312328029; W224312328035; W224312328036; W224312328038; W224312328044; W224312328045; W224312328048; W224312328052; W224312328073; ",".","12","Blood products, which did not meet acceptable product specifications, were distributed.",1/25/2013,"01/25/2013",9/18/2013,"09/18/2013"
"Biologics",65524,"Terminated","OneBlood, Inc.","Hialeah","FL","US","Voluntary: Firm Initiated","Letter","Florida","B-2236-13","Class II","Fresh Frozen Plasma","W036811231873; ",".","1","Blood products, collected from a donor in whom donor suitability was not adequately determined, were distributed.",5/28/2013,"05/28/2013",9/18/2013,"09/18/2013"
"Biologics",65524,"Terminated","OneBlood, Inc.","Hialeah","FL","US","Voluntary: Firm Initiated","Letter","Florida","B-2237-13","Class II","Red Blood Cells Leukocytes Reduced Irradiated","W036811231873; ",".","1","Blood products, collected from a donor in whom donor suitability was not adequately determined, were distributed.",5/28/2013,"05/28/2013",9/18/2013,"09/18/2013"
"Biologics",65525,"Terminated","International Sight Restoration, Inc.","Tampa","FL","US","Voluntary: Firm Initiated","E-Mail","Egypt; Florida","B-2275-13","Class III","Cornea","20130076OD; 20130076OS",".","2 corneas","Human corneas, recovered from a donor whose donor eligibility determination failed to ensure that the donor was free from risk factors for, and clinical evidence of infection due to relevant communicable disease agents and diseases, were distributed. ",6/5/2013,"06/05/2013",9/11/2013,"09/11/2013"
"Biologics",65526,"Terminated","Blood Bank Of Delmarva, Inc","Newark","DE","US","Voluntary: Firm Initiated","Telephone","Delaware; Maryland","B-2238-13","Class III","Red Blood Cells Leukocytes Reduced Irradiated","W036913208344; W036913208349; W036913208924; ",".","3","Blood products, which were labeled with incorrect expiration dates, were distributed.",4/26/2013,"04/26/2013",9/18/2013,"09/18/2013"
"Biologics",65527,"Terminated","Immucor Inc","Norcross","GA","US","Voluntary: Firm Initiated","E-Mail","Nationwide; Worldwide","B-2276-13","Class III","Reagent Red Blood Cells","N338; N339; N340; N341; R276; R277ZA; R278; CW249ZA; CW249ZB; CW250ZA; CW250ZB",".","11","Capture-R Ready plates, with higher rates of equivocal and unexpected positive reactions, were distributed. ",3/22/2013,"03/22/2013",9/11/2013,"09/11/2013"
"Biologics",65528,"Terminated","Blood Systems, Inc. dba United Blood Services Texas","El Paso","TX","US","Voluntary: Firm Initiated","FAX","TX","B-1636-13","Class II","Red Blood Cells Leukocytes Reduced","W041112066647F; W041112054611T ",".","2 units","Blood products, collected from a donor who traveled to a malaria endemic area, were distributed.",5/9/2013,"05/09/2013",10/2/2013,"10/02/2013"
"Biologics",65529,"Terminated","OneBlood / dba CBCF","Lauderhill","FL","US","Voluntary: Firm Initiated","Letter","Illinois; Florida; New York","B-2294-13","Class III","Blood and Blood Products for Reprocessing","W036809286286; ",".","1 unit","Blood products, collected from an ineligible donor, were distributed. ",6/3/2013,"06/03/2013",9/11/2013,"09/11/2013"
"Biologics",65529,"Terminated","OneBlood / dba CBCF","Lauderhill","FL","US","Voluntary: Firm Initiated","Letter","Illinois; Florida; New York","B-2295-13","Class II","Cryoprecipitated AHF, Pooled","W036809813030; ",".","1 unit","Blood products, collected from an ineligible donor, were distributed. ",6/3/2013,"06/03/2013",9/11/2013,"09/11/2013"
"Biologics",65529,"Terminated","OneBlood / dba CBCF","Lauderhill","FL","US","Voluntary: Firm Initiated","Letter","Illinois; Florida; New York","B-2293-13","Class II","Red Blood Cells","W036809286286; ",".","1 unit","Blood products, collected from an ineligible donor, were distributed. ",6/3/2013,"06/03/2013",9/11/2013,"09/11/2013"
"Biologics",65530,"Terminated","OneBlood, Inc.","Hialeah","FL","US","Voluntary: Firm Initiated","Letter","Switzerland; FL","B-2249-13","Class II","Platelets Pooled Leukocytes Reduced","W036809818928",".","1 unit","Blood products, collected from a donor in which donor suitability was not adequately determined, were distributed.",6/4/2013,"06/04/2013",10/2/2013,"10/02/2013"
"Biologics",65530,"Terminated","OneBlood, Inc.","Hialeah","FL","US","Voluntary: Firm Initiated","Letter","Switzerland; FL","B-2250-13","Class III","Blood and Blood Products for Reprocessing","W036809267543",".","1 unit","Blood products, collected from a donor in which donor suitability was not adequately determined, were distributed.",6/4/2013,"06/04/2013",10/2/2013,"10/02/2013"
"Biologics",65530,"Terminated","OneBlood, Inc.","Hialeah","FL","US","Voluntary: Firm Initiated","Letter","Switzerland; FL","B-2248-13","Class II","Red Blood Cells","W036809267543",".","1 unit","Blood products, collected from a donor in which donor suitability was not adequately determined, were distributed.",6/4/2013,"06/04/2013",10/2/2013,"10/02/2013"
"Biologics",65531,"Completed","OneBlood / dba CBCF","Lauderhill","FL","US","Voluntary: Firm Initiated","Telephone","Florida; New York","B-2286-13","Class II","Red Blood Cells","1446134; 1560763; 1684061; 1670207; 2083904; ",".","5 units","Blood products, collected from an ineligible donor, were distributed. ",5/23/2013,"05/23/2013",9/18/2013,"09/18/2013"
"Biologics",65531,"Completed","OneBlood / dba CBCF","Lauderhill","FL","US","Voluntary: Firm Initiated","Telephone","Florida; New York","B-2287-13","Class II","Fresh Frozen Plasma","1446134; 1570308; 1684061; 1670207; 2083904; ",".","5 units","Blood products, collected from an ineligible donor, were distributed. ",5/23/2013,"05/23/2013",9/18/2013,"09/18/2013"
"Biologics",65531,"Completed","OneBlood / dba CBCF","Lauderhill","FL","US","Voluntary: Firm Initiated","Telephone","Florida; New York","B-2288-13","Class II","Platelets","1570308; 1684061; 2083904; ",".","3 units","Blood products, collected from an ineligible donor, were distributed. ",5/23/2013,"05/23/2013",9/18/2013,"09/18/2013"
"Biologics",65531,"Completed","OneBlood / dba CBCF","Lauderhill","FL","US","Voluntary: Firm Initiated","Telephone","Florida; New York","B-2289-13","Class II","Red Blood Cells Leukocytes Reduced","1570308; ",".","1 unit","Blood products, collected from an ineligible donor, were distributed. ",5/23/2013,"05/23/2013",9/18/2013,"09/18/2013"
"Biologics",65532,"Completed","OneBlood, Inc.","Hialeah","FL","US","Voluntary: Firm Initiated","Telephone","Michigan; Florida","B-2284-13","Class II","Platelets Pooled Leukocytes Reduced Irradiated","W036809801545; ",".","1 unit","Blood product, collected from an inelgible donor, was distributed. ",5/20/2013,"05/20/2013",9/18/2013,"09/18/2013"
"Biologics",65532,"Completed","OneBlood, Inc.","Hialeah","FL","US","Voluntary: Firm Initiated","Telephone","Michigan; Florida","B-2285-13","Class II","Fresh Frozen Plasma","W036809163266; ",".","1 unit ","Blood product, collected from an inelgible donor, was distributed. ",5/20/2013,"05/20/2013",9/18/2013,"09/18/2013"
"Biologics",65532,"Completed","OneBlood, Inc.","Hialeah","FL","US","Voluntary: Firm Initiated","Telephone","Michigan; Florida","B-2283-13","Class II","Red Blood Cells","W036809163266; ",".","1 unit","Blood product, collected from an inelgible donor, was distributed. ",5/20/2013,"05/20/2013",9/18/2013,"09/18/2013"
"Biologics",65533,"Terminated","OneBlood / dba CBCF","Lauderhill","FL","US","Voluntary: Firm Initiated","Telephone","Michigan; Florida","B-1829-13","Class III","Blood and Blood Products for Reprocessing","W036812623250; ",".","1 unit","Blood product, collected fron an ineligible donor, was distributed. ",5/7/2013,"05/07/2013",9/18/2013,"09/18/2013"
"Biologics",65533,"Terminated","OneBlood / dba CBCF","Lauderhill","FL","US","Voluntary: Firm Initiated","Telephone","Michigan; Florida","B-1828-13","Class II","Platelets Pooled Leukocytes Reduced","W036812850044; ",".","1 unit","Blood product, collected fron an ineligible donor, was distributed. ",5/7/2013,"05/07/2013",9/18/2013,"09/18/2013"
"Biologics",65533,"Terminated","OneBlood / dba CBCF","Lauderhill","FL","US","Voluntary: Firm Initiated","Telephone","Michigan; Florida","B-1830-13","Class II","Red Blood Cells Leukocytes Reduced","W036812623250; ",".","1 unit","Blood product, collected fron an ineligible donor, was distributed. ",5/7/2013,"05/07/2013",9/18/2013,"09/18/2013"
"Biologics",65534,"Terminated","OneBlood, Inc.","Hialeah","FL","US","Voluntary: Firm Initiated","Telephone","FL","B-2270-13","Class II","Red Blood Cells","W036811019372",".","1 unit","Blood products, which were collected from a donor in which donor suitability was not adequately determined, were distributed.",6/10/2013,"06/10/2013",10/2/2013,"10/02/2013"
"Biologics",65534,"Terminated","OneBlood, Inc.","Hialeah","FL","US","Voluntary: Firm Initiated","Telephone","FL","B-2271-13","Class II","Fresh Frozen Plasma","W036811019372",".","1 unit","Blood products, which were collected from a donor in which donor suitability was not adequately determined, were distributed.",6/10/2013,"06/10/2013",10/2/2013,"10/02/2013"
"Biologics",65535,"Terminated","OneBlood, Inc.","Lantana","FL","US","Voluntary: Firm Initiated","Telephone","FL","B-2268-13","Class II","Red Blood Cells","2077018",".","1 unit","Blood products, collected from a donor in which donor suitability was not adequately determined, were distributed.",6/7/2013,"06/07/2013",10/2/2013,"10/02/2013"
"Biologics",65535,"Terminated","OneBlood, Inc.","Lantana","FL","US","Voluntary: Firm Initiated","Telephone","FL","B-2269-13","Class II","Platelets","2077018",".","1 unit","Blood products, collected from a donor in which donor suitability was not adequately determined, were distributed.",6/7/2013,"06/07/2013",10/2/2013,"10/02/2013"
"Biologics",65536,"Terminated","Central Blood Bank","Pittsburgh","PA","US","Voluntary: Firm Initiated","Telephone","PA","B-1635-13","Class II","Platelets Pheresis Leukocytes Reduced","W085313001566-part 1; W085313001566-part 2 ",".","2 units","Blood products, which did not meet the acceptable product specifications, were distributed.",5/3/2013,"05/03/2013",10/2/2013,"10/02/2013"
"Biologics",65537,"Terminated","American National Red Cross, Penn-Jersey Region","Philadelphia","PA","US","Voluntary: Firm Initiated","Telephone","Pennsylvania; New Jersey","B-2273-13","Class II","Platelets Pheresis Leukocytes Reduced","022LL72748; 022LL72748; ",".","2 units","Blood product, mislabeled as leukoreduced, was distributed. ",4/22/2013,"04/22/2013",9/11/2013,"09/11/2013"
"Biologics",65538,"Terminated","Blood Systems, Inc. dba United Blood Services Texas","El Paso","TX","US","Voluntary: Firm Initiated","Other","Switzerland","B-1831-13","Class II","Blood and Blood Products for Reprocessing","W041111105120G; ",".","1 unit","Blood products, collected from an ineligible donor, were distributed.",5/9/2013,"05/09/2013",9/11/2013,"09/11/2013"
"Food",65540,"Ongoing","Windy Acres Candy & Nut, Outlet Inc.","Wilmington","OH","US","Voluntary: Firm Initiated","Telephone","The product was distributed only to two consignees in the state of Ohio.","F-1720-2013","Class I","RAW SUNFLOWER KERNEL, DARK RAISIN 50/50 MIX 24/l0 oz packaged in clear plastic wrap. ","The affected product includes finished product lot number 0943, which was made using supplier lot number PRO-1349. ",".","7,968 units of 10 oz bags, 24 bags/case; 332 cases total","Windy Acres Candy and Nut recalled the affected product because they were informed by the supplier, Lipari Foods, that the sunflower seeds were potentially contaminated with Listeria monocytogenes. ",6/7/2013,"06/07/2013",7/24/2013,"07/24/2013"
"Drugs",65541,"Ongoing","Watson Laboratories, Inc.-(Actavis) - Florida","Davie","FL","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Nationwide","D-817-2013","Class II","Diclofenac Sodium and Misoprostol Delayed-Release Tablets, 75mg/0.2mg, 60-count bottle, Rx only, Manufactured by Watson Laboratories, Inc., Corona, CA 92880, NDC 0591-0398-60","Lot 635098A, Exp 10/14",,"392,400 tablets","Failed Tablet/Capsule Specifications: Broken tablets",3/22/2013,"03/22/2013",7/31/2013,"07/31/2013"
"Devices",65542,"Completed","Myoscience Inc","Redwood City","CA","US","Voluntary: Firm Initiated","Visit","US distribution including CA and ID.","Z-1781-2013","Class II","Myoscience brand iovera Smart Tip, Myoscience Cryo-Touch IV, a Cryogenic Surgical device, REF Catalog Number: STA0311-10. Product Usage: The Myoscience Cryo-Touch IV (a.k.a. iovera) is used to destroy tissue during surgical procedures by applying freezing cold. It can also be used to produce lesions in peripheral nervous tissue by the application of cold to the selected site for the blocking of pain. The Cryo-Touch IV (a.k.a. iovera) is not indicated for treatment of central nervous system tissue. ","Serial Numbers: 100100, 100101, 100103",,"3 units","The outer box label of the product was labeled with a down revision label which did not include the US labeling requirements, specifically the symbol descriptors and also the ''Caution: Federal Law (USA) restricts this device to sale by or on the order of a physician.'' This product was previously labeled for EU distribution only. ",6/21/2013,"06/21/2013",7/31/2013,"07/31/2013"
"Drugs",65543,"Ongoing","AstraZeneca Pharmaceuticals LP","Wilmington","DE","US","Voluntary: Firm Initiated","Letter","USA and Puerto Rico","D-840-2013","Class II","MERREM I.V. (meropenem for injection), 1 g meropenem equivalent, 30 mL vial, Rx only, Mfd for: AstraZeneca Pharmaceuticals LP, Wilmington, DE by ACS Dobfar SpA Viale Addetta, Tribiano, Milano Italy NDC 0310 0321 30","NDC 0310-321-30, lot JX109, expiration 2/2015; lot JY042, expiration 2/2015",".","81,900 total vials ","Presence of Precipitate; potential for incomplete constitution upon addition of diluent. ",6/21/2013,"06/21/2013",8/14/2013,"08/14/2013"
"Devices",65544,"Ongoing","Mesa Laboratories, Inc., Bozeman Manufacturing Facility","Bozeman","MT","US","Voluntary: Firm Initiated","E-Mail","Worldwide Distribution: US (nationwide) and countries of: Australia, Brazil, Bulgaria, Canada, China, Colombia, Croatia, Egypt, Greece, India,Israel, Japan, Jordan, Malaysia, Mexico, Milanese, Netherlands, Peru, Portugal, Pozan, Romania, Spain, Sweden, Taiwan, Thailand, United Kingdom, and Uruguay.","Z-1867-2013","Class II","Mesa EZtest BIOLOGICAL INDICATOR MONITORING SYSTEM. Intended for use in determining the efficacy of steam sterilization processes.","Lot No S-444 Manufacture Date 2013 January 21 Expiration Date 2015 January 21; Lot No S-445 Manufacture Date 2013 February 15 Expiration Date 2015 February 15 ; Lot No S-447 Manufacture Date 2013 March 18 Expiration Date 2015 March 18. ",,"865/25 ct boxes, 414/100 ct boxes, 307/500 ct boxes","Mesa EZTest , Self-contained steam biological indicator, are recalled because Mesa recently determined that the read out time is not in specification with the label claims. ",6/4/2013,"06/04/2013",8/7/2013,"08/07/2013"
"Devices",65544,"Ongoing","Mesa Laboratories, Inc., Bozeman Manufacturing Facility","Bozeman","MT","US","Voluntary: Firm Initiated","E-Mail","Worldwide Distribution: US (nationwide) and countries of: Australia, Brazil, Bulgaria, Canada, China, Colombia, Croatia, Egypt, Greece, India,Israel, Japan, Jordan, Malaysia, Mexico, Milanese, Netherlands, Peru, Portugal, Pozan, Romania, Spain, Sweden, Taiwan, Thailand, United Kingdom, and Uruguay.","Z-1868-2013","Class II","Mesa Smart-Read EZTEST BIOLOGICAL INDICATOR MONITORING SYSTEM. Intended for use in determining the efficacy of steam sterilization processes.","Lot No SR-444 Manufacture Date 2013 January 21 Expiration Date 2015 January 21; Lot No SR-445 Manufacture Date 2013 February 15 Expiration Date 2015 February 15. Lot No SR-447 Manufacture Date 2013 March 18 Expiration Date 2015 March 18. ",,"2447/100 count boxes","Self-contained steam biological indicator, are recalled because Mesa recently determined that the read out time is not in specification with the label claims. ",6/4/2013,"06/04/2013",8/7/2013,"08/07/2013"
"Food",65545,"Ongoing","Bergin Fruit And Nut Co Inc","Saint Paul","MN","US","Voluntary: Firm Initiated","Letter","CA, ID, IL, IN, IA, KS, KY, MI, MN, NV, ND, PA, SD, TN, WI.","F-1741-2013","Class I","600908.03 PISTACHIOS KERNELS R/S 12/16 OZ TRAY KOWALSKI, UPC 2052600908 600909 PISTACHIOS KERNELS R/S 16/7 OZ CLAMSHELL, UPC 2052600909 600909.03 PISTACHIOS KERNELS R/S 16/7 OZ CLAMSHELL KOWALSKI, IUPAC 600904 PISTACHIOS KERNELS R/S 30#, UPC 2052600904 600905 PISTACHIOS KERNELS R/S 5#, UPC 2052600905 600906 PISTACHIOS KERNELS R/S 12/16 OZ BAGLINE, IUPAC. ","5/30/2014, 4/12/2014, 6/4/2014, 5/7/2014, 1/17/2014.",,"159.12","Bergin Fruit and Nut Company is initiating a recall on a number of pistachio products manufactured using pistachios supplied by ARO Pistachio Inc. Salmonella was found in the environment at the ARO Pistachio Inc. company. ",6/6/2013,"06/06/2013",7/31/2013,"07/31/2013"
"Food",65545,"Ongoing","Bergin Fruit And Nut Co Inc","Saint Paul","MN","US","Voluntary: Firm Initiated","Letter","CA, ID, IL, IN, IA, KS, KY, MI, MN, NV, ND, PA, SD, TN, WI.","F-1740-2013","Class I","600943 PISTACHIOS KERNELS RAW 8/11 OZ SQ TUB, UPC 2052600943 601902 PISTACHIOS KERNELS RAW 10/14 OZ TAPE BAG, UPC 2052601902 601902.09 PISTACHIOS KERNELS RAW 10/14 OZ TAPE BAG BYERLYS, UPC 2052601902 600899 PISTACHIOS KERNELS RAW 30#, IUPAC 600901 PISTACHIOS KERNELS RAW 5#, UPC 2052600901 600900.05 PISTACHIOS KERNELS RAW 12/16 BAGLINE FESTIVAL, UPC 2052600900. 601902.08 PISTACHIOS KERNELS RAW 10/14 OZ TAPE BAG LUNDS RAW PISTACHIO KERNELS, UPC 2052601902. ","5/31/204, 5/24/2014, 5/28/2014, 12/13/2013, 6/3/2014, 4/2/2014, 1/8/2014.",,"401.07","Bergin Fruit and Nut Company is initiating a recall on a number of pistachio products manufactured using pistachios supplied by ARO Pistachio Inc. Salmonella was found in the environment at the ARO Pistachio Inc. company. ",6/6/2013,"06/06/2013",7/31/2013,"07/31/2013"
"Food",65545,"Ongoing","Bergin Fruit And Nut Co Inc","Saint Paul","MN","US","Voluntary: Firm Initiated","Letter","CA, ID, IL, IN, IA, KS, KY, MI, MN, NV, ND, PA, SD, TN, WI.","F-1738-2013","Class I","604293 MEGA OMEGA MIX 12/8 OZ SQ TUB, UPC 2052604293 604293.04 MEGA OMEGA MIX 12/8 OZ SQ TUB BOULDER, UPC 2052604293 604293.05 MEGA OMEGA MIX 12/8 OZ SQ TUB FESTIVAL, UPC 2052604293 604290 MEGA OMEGA MIX 15#, UPC 2052604290 604292 MEGA OMEGA MIX 16/7 OZ - CLAMSHELL,UPC 2052604292 604291 MEGA OMEGA MIX 5#, UPC 2052604291 ","11/26/13, 1/11/2014, 1/19/2014,1/11/2014, 1/22/2014, 1/28/2014, 1/29/2014.",,"331.3","Bergin Fruit and Nut Company is initiating a recall on a number of pistachio products manufactured using pistachios supplied by ARO Pistachio Inc. Salmonella was found in the environment at the ARO Pistachio Inc. company. ",6/6/2013,"06/06/2013",7/31/2013,"07/31/2013"
"Food",65545,"Ongoing","Bergin Fruit And Nut Co Inc","Saint Paul","MN","US","Voluntary: Firm Initiated","Letter","CA, ID, IL, IN, IA, KS, KY, MI, MN, NV, ND, PA, SD, TN, WI.","F-1737-2013","Class I","601180 LOW GLYCEMIC SNACK MIX 12/4 OZ BERGIN RED BAG, UPC 2052601180 601082 LOW GLYCEMIC SNACK MIX 12/8 CLAMSHELL, UPC 2052601082 601082.03 LOW GLYCEMIC SNACK MIX 12/8 CLAMSHELL KOWALSKI, UPC 2052601082 601080 LOW GLYCEMIC SNACK MIX 30#, UPC 2052601080 601084 LOW GLYCEMIC SNACK MIX 5#, UPC 2052601084 601083.04 LOW GLYCEMIC SNACK MIX 8/10 OZ SQ TUB, UPC 2052601083 601083 LOW GLYCEMIC SNACK MIX 8/10 OZ SQ TUB, UPC 2052601083 ","10/6/2013, 11/27/2013, 12/31/2013, 1/18/2014, 1/27/2014, 1/28/2014.",,"93.03","Bergin Fruit and Nut Company is initiating a recall on a number of pistachio products manufactured using pistachios supplied by ARO Pistachio Inc. Salmonella was found in the environment at the ARO Pistachio Inc. company. ",6/6/2013,"06/06/2013",7/31/2013,"07/31/2013"
"Food",65545,"Ongoing","Bergin Fruit And Nut Co Inc","Saint Paul","MN","US","Voluntary: Firm Initiated","Letter","CA, ID, IL, IN, IA, KS, KY, MI, MN, NV, ND, PA, SD, TN, WI.","F-1735-2013","Class I","601041 HEALTHY HEART MIX 12/14 OZ TRAY, UPC 2052601041 601078 HEALTHY HEART MIX 12/8 OZ CLAMSHELL, UPC 2052601078 601078.03 HEALTHY HEART MIX 12/8 OZ CLAMSHELL KOWALSKI, UPC 2052601078 601089 HEALTHY HEART MIX 16/6 OZ CLAMSHELL, UPC 2052601089 601089.1 HEALTHY HEART MIX 16/6 OZ CLAMSHELL CUB, UPC 1115099868 601125 HEALTHY HEART MIX 8/10 OZ SQ TUB, UPC 2052601125 601125.04 HEALTHY HEART MIX 8/10 OZ SQ TUB BOULDER, UPC 2052601125 601125.05 HEALTHY HEART MIX 8/10 OZ SQ TUB FESTIVAL, UPC 2052601125 601063 HEALTHY HEART NUT MIX 12/16 OZ BAGLINE, UPC 2052601063 601061.05 HEALTHY HEART NUT MIX 12/16 OZ FESTIVAL, UPC 2052601061 601037 HEALTHY HEART NUT MIX 30#, UPC 2052601037 601038 HEALTHY HEART NUT MIX 5#, UPC 2052601038 601089.01 HEALTHY HEART MIX 16/6 OZ CLAMSHELL, UPC 1115099868 602037 HEALTHY HEART NUT MIX 2/5#, UPC 2052602037 601137.00 HEALTHY HEART MIX 12/7 OZ BERGIN CUSTOM ZIPLOCK POUCH DISCONTINUED HEALTHY HEART MIX***, UPC 2052601137","Best By: 11/20/2013, 12/11/2013, 11/23/2013, 1/28/2014, 1/11/2014, 1/12/2014, 1/18/2014, 1/21/2014, 1/22/2014, 1/29/2014, 2/2/2014.",,"1527.59","Bergin Fruit and Nut Company is initiating a recall on a number of pistachio products manufactured using pistachios supplied by ARO Pistachio Inc. Salmonella was found in the environment at the ARO Pistachio Inc. company. ",6/6/2013,"06/06/2013",7/31/2013,"07/31/2013"
"Food",65545,"Ongoing","Bergin Fruit And Nut Co Inc","Saint Paul","MN","US","Voluntary: Firm Initiated","Letter","CA, ID, IL, IN, IA, KS, KY, MI, MN, NV, ND, PA, SD, TN, WI.","F-1734-2013","Class I","601009 ANTIOXIDANT SUPERSTAR MIX 100/2 OZ FLAT PACK, UPC 2052601009 601076 ANTIOXIDANT SUPERSTAR MIX 12/6 OZ BERGIN RED BAG, UPC 2052601076 601051 ANTIOXIDANT SUPERSTAR MIX 12/8 OZ CLAMSHELL, UPC 2052601051 601051.03 ANTIOXIDANT SUPERSTAR MIX 12/8 OZ CLAMSHELL KOWALSKI, UPC 2052601051 601049.01 ANTIOXIDANT SUPERSTAR MIX 16/6 OZ CLAMSHELL, UPC 1115099870 601049.1 ANTIOXIDANT SUPERSTAR MIX 16/6 OZ CLAMSHELL CUB, IUPAC 601070 ANTIOXIDANT SUPERSTAR MIX 3/5#, UPC 2052601070 601050 ANTIOXIDANT SUPERSTAR MIX 30#, UPC 2052601050 601052 ANTIOXIDANT SUPERSTAR MIX 5#, UPC 2052601052 601069 ANTIOXIDANT SUPERSTAR MIX 8/10 OZ SQ TUB, UPC 2052601069 601069.05 ANTIOXIDANT SUPERSTAR MIX 8/10 OZ SQ TUB FESTIVAL, UPC 2052601069 601054 ANTIOXIDANT SUPERSTAR MX 12/10 OZ BAGLINE, UPC 2052601054 601069.04 ANTIOXIDANT SUPERSTAR MIX 8/10 OZ SQ TUB BOULDER, IUPAC 601048.00 ANTIOXIDANT SUPERSTAR MIX 100/2 OZ FLAT PACK PROMOTIONAL ANTIOXIDANT SUPERSTAR MIX***, UPC 2052601048. 601049.00 ANTIOXIDANT SUPERSTAR MIX 16/6 OZ CLAMSHELL SUPER ANTIOXIDANT MIX***, UPC 2052601049 612150.03 LARGE GIFT BOX KOWALSKIS, UPC 2052612150. ","Best By 6/22/2013, 10/6/2013, 10/10/2013,10/30/2013, 12/29/2013, 1/8/2014, 1/12/2014, 2/1/14, 2/2/2014, 1/26/2014, 1/28/2014. ",,"1705.55","Bergin Fruit and Nut Company is initiating a recall on a number of pistachio products manufacturing using pistachios supplied by ARO Pistachio Company. The recall was initiated because Salmonella was found in the environment at the ARO Pistachio Company. ",6/6/2013,"06/06/2013",7/31/2013,"07/31/2013"
"Food",65545,"Ongoing","Bergin Fruit And Nut Co Inc","Saint Paul","MN","US","Voluntary: Firm Initiated","Letter","CA, ID, IL, IN, IA, KS, KY, MI, MN, NV, ND, PA, SD, TN, WI.","F-1742-2013","Class I","603684 PISTACHIOS S/I/S 12/10 OZ GOLD BAG, UPC 2052603684 600913 PISTACHIOS S/I/S 12/12 OZ BAGLINE, UPC 2052600913 600913.11 PISTACHIOS S/I/S 12/12 OZ BAGLINE AMAZON, UPC 2052600913 600913.07 PISTACHIOS S/I/S 12/12 OZ BAGLINE DISPLAY BOX, UPC 2052600913 600923.05 PISTACHIOS S/I/S 12/12 OZ BAGLINE FESTIVAL, UPC 2052600923 600915 PISTACHIOS S/I/S 12/12 OZ TRAY, UPC 2052600915 603672 PISTACHIOS S/I/S 12/26 OZ TIN HOLIDAY CLOSED SLEEVE, UPC 2052603672 600921 PISTACHIOS S/I/S 12/8 OZ CLAMSHELL, UPC2052600921 603667 PISTACHIOS S/I/S 16/15 OZ TIN HOLIDAY CLOSED SLEEVE, UPC 2052603667 600912 PISTACHIOS S/I/S 25#, UPC 2052600912 600914 PISTACHIOS S/I/S 4/20 OZ TUB, UPC 2052600914 600914.03 PISTACHIOS S/I/S 4/20 OZ TUB KOWALSKI, UPC 2052600914 603677 PISTACHIOS S/I/S 4/36 OZ TIN HOLIDAY CLOSED SLEEVE, UPC 2052603677 603902 PISTACHIOS S/I/S 4/36 OZ TIN HOLIDAY OPEN SLEEVE, UPC2052603902 600911 PISTACHIOS S/I/S 5#, UPC 2052600911 600927.04 PISTACHIOS S/I/S 8/8 OZ SQ TUB BOULDER, UPC 2052600927 600927.05 PISTACHIOS S/I/S 8/8 OZ SQ TUB FESTIVAL, UPC 2052600927 601912 PISTACHIOS S/IS 10/14 OZ TAPE BAG, UPC2052601912 601912.09 PISTACHIOS S/IS 10/14 OZ TAPE BAG BYERLYS, UPC 2052601912 601912.08 PISTACHIOS S/IS 10/14 OZ TAPE BAG LUNDS, UPC 2052601912 603858.00 PISTACHIOS S/I/S 12/26 OZ OPEN SLEEVE IN SHELL PISTACHIOS, UPC 2052603858. ","11/15/2013, 12/13/2013, 5/24/2013, 6/3/2014, 6/5/2014, 5/30/2014, 6/4/204, 5/31/2014,2/25/2014, 3/22/2014, 5/23/2014, 5/7/2014, 3/29/2014, 1/18/2014. 5/28/2014.",,"914.05","Bergin Fruit and Nut Company is initiating a recall on a number of pistachio products manufactured using pistachios supplied by ARO Pistachio Inc. Salmonella was found in the environment at the ARO Pistachio Inc. company. ",6/6/2013,"06/06/2013",7/31/2013,"07/31/2013"
"Food",65545,"Ongoing","Bergin Fruit And Nut Co Inc","Saint Paul","MN","US","Voluntary: Firm Initiated","Letter","CA, ID, IL, IN, IA, KS, KY, MI, MN, NV, ND, PA, SD, TN, WI.","F-1739-2013","Class I","601911 PISTACHIO KERNELS HOT & SPICY 30#, UPC 2052601911 601913 PISTACHIOS HOT AND SPICY 12/5 OZ BERGIN RED BAG, UPC 2052601913 ","5/24/2014, 5/28/2014.",,"11.27","Bergin Fruit and Nut Company is initiating a recall on a number of pistachio products manufactured using pistachios supplied by ARO Pistachio Inc. Salmonella was found in the environment at the ARO Pistachio Inc. company. ",6/6/2013,"06/06/2013",7/31/2013,"07/31/2013"
"Food",65545,"Ongoing","Bergin Fruit And Nut Co Inc","Saint Paul","MN","US","Voluntary: Firm Initiated","Letter","CA, ID, IL, IN, IA, KS, KY, MI, MN, NV, ND, PA, SD, TN, WI.","F-1736-2013","Class I","604320 LOW GLYCEMIC INSTANT OATMEAL 25#, UPC 2052604320 ","Best By: 12/4/2013",,"15","Bergin Fruit and Nut Company is initiating a recall on a number of pistachio products manufactured using pistachios supplied by ARO Pistachio Inc. Salmonella was found in the environment at the ARO Pistachio Inc. company. ",6/6/2013,"06/06/2013",7/31/2013,"07/31/2013"
"Food",65545,"Ongoing","Bergin Fruit And Nut Co Inc","Saint Paul","MN","US","Voluntary: Firm Initiated","Letter","CA, ID, IL, IN, IA, KS, KY, MI, MN, NV, ND, PA, SD, TN, WI.","F-1743-2013","Class I","600910 PISTACHIOS SPLITS RAW 30#, UPC 2052600910 ","4/25/2014",,"23","Bergin Fruit and Nut Company is initiating a recall on a number of pistachio products manufactured using pistachios supplied by ARO Pistachio Inc. Salmonella was found in the environment at the ARO Pistachio Inc. company. ",6/6/2013,"06/06/2013",7/31/2013,"07/31/2013"
"Biologics",65547,"Terminated","Community Blood Center of Carolinas","Charlotte","NC","US","Voluntary: Firm Initiated","Telephone","NC","B-2358-13","Class II","Red Blood Cells Leukocytes Reduced","W227013012155",,"1 unit","Blood product, collected from a donor in which donor suitability was not adequately determined, was distributed.",6/6/2013,"06/06/2013",11/27/2013,"11/27/2013"
"Biologics",65548,"Terminated","Community Blood Center of Carolinas","Charlotte","NC","US","Voluntary: Firm Initiated","Telephone","NC","B-2360-13","Class II","Red Blood Cells Leukocytes Reduced","W227012040047",,"1 unit","Blood products, collected from a donor who received a piercing within 12 months of donation, were distributed.",6/10/2013,"06/10/2013",11/27/2013,"11/27/2013"
"Biologics",65548,"Terminated","Community Blood Center of Carolinas","Charlotte","NC","US","Voluntary: Firm Initiated","Telephone","NC","B-2361-13","Class II","Fresh Frozen Plasma","W227012040047",,"1 unit","Blood products, collected from a donor who received a piercing within 12 months of donation, were distributed.",6/10/2013,"06/10/2013",11/27/2013,"11/27/2013"
"Biologics",65549,"Terminated","Coffee Memorial Blood Center","Amarillo","TX","US","Voluntary: Firm Initiated","E-Mail","Korea, Republic Of(South)","B-2359-13","Class III","Blood and Blood Products for Reprocessing","W067313001392",,"1 unit","Blood product, which was collected from a donor in which donor suitability was not adequately determined, was distributed.",5/16/2013,"05/16/2013",11/27/2013,"11/27/2013"
"Devices",65552,"Ongoing","Invacare Corporation","Elyria","OH","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Nationwide distribution: USA including states of: CA, FL, IN, MN, NJ, NY, OH, RI, SC, SD, TX, and VA.","Z-1980-2013","Class II","CHAMPION Medical Recliner, AC Powered with heat and massage, one chair per carton, or one chair wrapped in a blanket if delivered in person. Recliner provides heat and massage after surgery.","The following model numbers are affected by this recall: 54PGS636-7JM; 56PLV04-TRL4LJM; 59PT09-F7CJM; 68PT96-TS7JM; 86PT26-TS7JM3; 54PLV04-TRL4LJM; 56PSR20-TS7JM; 59PT19-TFS7PJM3; 85PSR12-TS7JM3; 86PT45-T7KJM; 54PSR20-TS7JM; 56PT21-TS7JM; 65PEV943X-TS7JM3; 85PSR30-TS7JM3; 89PCHA06-TFS7HJM; 54PT26-TS7CJM3; 56PT26-TS7CJM3; 65PFS26-TS7JM; 85PSU103-TS7JM; 89PEV921X-TFS7HPJM3; 54PT45-NJM 56PT45-NJM 65PSH12-S7JM 85PT09-TS7JM3 89PFS04-TFS7HPJM3; 54PT45-TNJM; 56PT45-RNJM; 65PT09-TS7JM; 85PT19-T7JM; 89PFS13-TFS7HPJM3; 54PT45-TS7JM; 58PCHA06-TFS7HJM; 65PT21-TS7JM; 85PT26-TS7JM3; 89PFS15-TFS7HPJM; 54PT56-T7JM; 59PGS493-TFS7HPJM; 66PCHA04-TS7JM; 86PCHA06-TS7JM; 89PFS26-TFS7HPJM3; 54PT96-TS7JM3; 59PGS493-TFS7HPJM3; 66PEV923X-TS7JM3; 86PSU103-TS7JM; 89PFS32-TFS7HPJM3; 56PGS636-7JM; 59PSR12-FS7JM3; 66PFS26-TS7JM; and 86PT09-TS7JM3. ",".","285 units","There is a possibility of elevated temperatures in the seat pad. In addition, the hospital cord set does not agree with the labeling (information in manual).",6/18/2013,"06/18/2013",8/28/2013,"08/28/2013"
"Devices",65553,"Ongoing","LeMaitre Vascular, Inc.","Burlington","MA","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Worldwide distribution: USA including PA and countries of: BRAZIL, BULGARIA, FRANCE, GEORGIA, GERMANY, GREECE, ITALY, LEBANON, NETHERLAND, POLAND, SPAIN, and TURKEY.","Z-1761-2013","Class I","AlboGraft Knitted with Collagen, Straight 40x08 Catalog Number: AMC4008 AlboGraft Vascular Grafts are made of synthetic material and designed to replace sections of damaged or malfunctioning arteries.","Lot number/Expiration Date 56890A 2015-04",,"3 units","Blood blushing/leaking from the surface of the graft after implantation",6/17/2013,"06/17/2013",7/31/2013,"07/31/2013"
"Devices",65553,"Ongoing","LeMaitre Vascular, Inc.","Burlington","MA","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Worldwide distribution: USA including PA and countries of: BRAZIL, BULGARIA, FRANCE, GEORGIA, GERMANY, GREECE, ITALY, LEBANON, NETHERLAND, POLAND, SPAIN, and TURKEY.","Z-1767-2013","Class I","AlboGraft Woven with Collagen, Straight 30x16 Catalog Number: ATC3016 AlboGraft Vascular Grafts are made of synthetic material and designed to replace sections of damaged or malfunctioning arteries.","Lot number/Expiration Date 56890A 2015-04",,"1 unit","Blood blushing/leaking from the surface of the graft after implantation",6/17/2013,"06/17/2013",7/31/2013,"07/31/2013"
"Devices",65553,"Ongoing","LeMaitre Vascular, Inc.","Burlington","MA","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Worldwide distribution: USA including PA and countries of: BRAZIL, BULGARIA, FRANCE, GEORGIA, GERMANY, GREECE, ITALY, LEBANON, NETHERLAND, POLAND, SPAIN, and TURKEY.","Z-1764-2013","Class I","AlboGraft Knitted with Collagen, Straight 60x08 Catalog Number: AMC6008 AlboGraft Vascular Grafts are made of synthetic material and designed to replace sections of damaged or malfunctioning arteries.","Lot number/Expiration Date 56890A 2015-04",,"2 units","Blood blushing/leaking from the surface of the graft after implantation",6/17/2013,"06/17/2013",7/31/2013,"07/31/2013"
"Devices",65553,"Ongoing","LeMaitre Vascular, Inc.","Burlington","MA","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Worldwide distribution: USA including PA and countries of: BRAZIL, BULGARIA, FRANCE, GEORGIA, GERMANY, GREECE, ITALY, LEBANON, NETHERLAND, POLAND, SPAIN, and TURKEY.","Z-1756-2013","Class I"," Albo Graft Knitted with Collagen, Bifurcate 16x08 Catalog Number: AMC1608 AlboGraft Vascular Grafts are made of synthetic material and designed to replace sections of damaged or malfunctioning arteries. ","Lot number/Expiration Date 56890A 2015-04",,"7 units","Blood blushing/leaking from the surface of the graft after implantation",6/17/2013,"06/17/2013",7/31/2013,"07/31/2013"
"Devices",65553,"Ongoing","LeMaitre Vascular, Inc.","Burlington","MA","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Worldwide distribution: USA including PA and countries of: BRAZIL, BULGARIA, FRANCE, GEORGIA, GERMANY, GREECE, ITALY, LEBANON, NETHERLAND, POLAND, SPAIN, and TURKEY.","Z-1766-2013","Class I","AlboGraft Woven with Collagen, Straight 15x30 Catalog Number: ATC1530 AlboGraft Vascular Grafts are made of synthetic material and designed to replace sections of damaged or malfunctioning arteries. ","Lot number/Expiration Date 56890A 2015-04",,"2 units","Blood blushing/leaking from the surface of the graft after implantation",6/17/2013,"06/17/2013",7/31/2013,"07/31/2013"
"Devices",65553,"Ongoing","LeMaitre Vascular, Inc.","Burlington","MA","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Worldwide distribution: USA including PA and countries of: BRAZIL, BULGARIA, FRANCE, GEORGIA, GERMANY, GREECE, ITALY, LEBANON, NETHERLAND, POLAND, SPAIN, and TURKEY.","Z-1758-2013","Class I","AlboGraft Knitted with Collagen, Bifurcate 18x10 Catalog Number: AMC1810 AlboGraft Vascular Grafts are made of synthetic material and designed to replace sections of damaged or malfunctioning arteries.","Lot number/Expiration Date 56890A 2015-04",,"1 unit","Blood blushing/leaking from the surface of the graft after implantation",6/17/2013,"06/17/2013",7/31/2013,"07/31/2013"
"Devices",65553,"Ongoing","LeMaitre Vascular, Inc.","Burlington","MA","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Worldwide distribution: USA including PA and countries of: BRAZIL, BULGARIA, FRANCE, GEORGIA, GERMANY, GREECE, ITALY, LEBANON, NETHERLAND, POLAND, SPAIN, and TURKEY.","Z-1757-2013","Class I","AlboGraft Knitted with Collagen, Bifurcate 18x09 Catalog Number: AMC1809 AlboGraft Vascular Grafts are made of synthetic material and designed to replace sections of damaged or malfunctioning arteries.","Lot number/Expiration Date 56890A 2015-04",,"3 units","Blood blushing/leaking from the surface of the graft after implantation",6/17/2013,"06/17/2013",7/31/2013,"07/31/2013"
"Devices",65553,"Ongoing","LeMaitre Vascular, Inc.","Burlington","MA","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Worldwide distribution: USA including PA and countries of: BRAZIL, BULGARIA, FRANCE, GEORGIA, GERMANY, GREECE, ITALY, LEBANON, NETHERLAND, POLAND, SPAIN, and TURKEY.","Z-1759-2013","Class I","AlboGraft Knitted with Collagen, Bifurcate 20x10Catalog Number: AMC2010 AlboGraft Vascular Grafts are made of synthetic material and designed to replace sections of damaged or malfunctioning arteries.","Lot number/Expiration Date 56890A 2015-04",,"3 units","Blood blushing/leaking from the surface of the graft after implantation",6/17/2013,"06/17/2013",7/31/2013,"07/31/2013"
"Devices",65553,"Ongoing","LeMaitre Vascular, Inc.","Burlington","MA","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Worldwide distribution: USA including PA and countries of: BRAZIL, BULGARIA, FRANCE, GEORGIA, GERMANY, GREECE, ITALY, LEBANON, NETHERLAND, POLAND, SPAIN, and TURKEY.","Z-1754-2013","Class I"," AlboGraft Knitted with Collagen, Bifurcate 14x08 Catalog Number: AMC1408 AlboGraft Vascular Grafts are made of synthetic material and designed to replace sections of damaged or malfunctioning arteries. ","Lot number/Expiration Date 56890A 2015-04",,"1 unit","Blood blushing/leaking from the surface of the graft after implantation",6/17/2013,"06/17/2013",7/31/2013,"07/31/2013"
"Devices",65553,"Ongoing","LeMaitre Vascular, Inc.","Burlington","MA","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Worldwide distribution: USA including PA and countries of: BRAZIL, BULGARIA, FRANCE, GEORGIA, GERMANY, GREECE, ITALY, LEBANON, NETHERLAND, POLAND, SPAIN, and TURKEY.","Z-1769-2013","Class I","AlboGraft Woven with Collagen, Straight 30x24 Catalog Number: ATC3024 AlboGraft Vascular Grafts are made of synthetic material and designed to replace sections of damaged or malfunctioning arteries.","Lot number/Expiration Date 56890A 2015-04",,"2 units","Blood blushing/leaking from the surface of the graft after implantation",6/17/2013,"06/17/2013",7/31/2013,"07/31/2013"
"Devices",65553,"Ongoing","LeMaitre Vascular, Inc.","Burlington","MA","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Worldwide distribution: USA including PA and countries of: BRAZIL, BULGARIA, FRANCE, GEORGIA, GERMANY, GREECE, ITALY, LEBANON, NETHERLAND, POLAND, SPAIN, and TURKEY.","Z-1770-2013","Class I","AlboGraft Woven with Collagen, Straight 30x26 Catalog Number: ATC3026 AlboGraft Vascular Grafts are made of synthetic material and designed to replace sections of damaged or malfunctioning arteries.","Lot number/Expiration Date 56890A 2015-04",,"3 units","Blood blushing/leaking from the surface of the graft after implantation",6/17/2013,"06/17/2013",7/31/2013,"07/31/2013"
"Devices",65553,"Ongoing","LeMaitre Vascular, Inc.","Burlington","MA","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Worldwide distribution: USA including PA and countries of: BRAZIL, BULGARIA, FRANCE, GEORGIA, GERMANY, GREECE, ITALY, LEBANON, NETHERLAND, POLAND, SPAIN, and TURKEY.","Z-1763-2013","Class I","AlboGraft Knitted with Collagen, Straight 60x07 Catalog Number: AMC6007 AlboGraft Vascular Grafts are made of synthetic material and designed to replace sections of damaged or malfunctioning arteries.","Lot number/Expiration Date 56890A 2015-04",,"2 untis","Blood blushing/leaking from the surface of the graft after implantation",6/17/2013,"06/17/2013",7/31/2013,"07/31/2013"
"Devices",65553,"Ongoing","LeMaitre Vascular, Inc.","Burlington","MA","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Worldwide distribution: USA including PA and countries of: BRAZIL, BULGARIA, FRANCE, GEORGIA, GERMANY, GREECE, ITALY, LEBANON, NETHERLAND, POLAND, SPAIN, and TURKEY.","Z-1765-2013","Class I","AlboGraft Woven with Collagen, Straight 15x26 Catalog Number: ATC1526 AlboGraft Vascular Grafts are made of synthetic material and designed to replace sections of damaged or malfunctioning arteries.","Lot number/Expiration Date 56890A 2015-04",,"2 units","Blood blushing/leaking from the surface of the graft after implantation",6/17/2013,"06/17/2013",7/31/2013,"07/31/2013"
"Devices",65553,"Ongoing","LeMaitre Vascular, Inc.","Burlington","MA","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Worldwide distribution: USA including PA and countries of: BRAZIL, BULGARIA, FRANCE, GEORGIA, GERMANY, GREECE, ITALY, LEBANON, NETHERLAND, POLAND, SPAIN, and TURKEY.","Z-1768-2013","Class I","AlboGraft Woven with Collagen, Straight 30x18 Catalog Number: ATC3018 AlboGraft Vascular Grafts are made of synthetic material and designed to replace sections of damaged or malfunctioning arteries.","Lot number/Expiration Date 56890A 2015-04",,"1 unit","Blood blushing/leaking from the surface of the graft after implantation",6/17/2013,"06/17/2013",7/31/2013,"07/31/2013"
"Devices",65553,"Ongoing","LeMaitre Vascular, Inc.","Burlington","MA","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Worldwide distribution: USA including PA and countries of: BRAZIL, BULGARIA, FRANCE, GEORGIA, GERMANY, GREECE, ITALY, LEBANON, NETHERLAND, POLAND, SPAIN, and TURKEY.","Z-1762-2013","Class I","AlboGraft Knitted with Collagen, Straight 60x06 Catalog Number: AMC6006 AlboGraft Vascular Grafts are made of synthetic material and designed to replace sections of damaged or malfunctioning arteries.","Lot number/Expiration Date 56890A 2015-04",,"3 units","Blood blushing/leaking from the surface of the graft after implantation",6/17/2013,"06/17/2013",7/31/2013,"07/31/2013"
"Devices",65553,"Ongoing","LeMaitre Vascular, Inc.","Burlington","MA","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Worldwide distribution: USA including PA and countries of: BRAZIL, BULGARIA, FRANCE, GEORGIA, GERMANY, GREECE, ITALY, LEBANON, NETHERLAND, POLAND, SPAIN, and TURKEY.","Z-1760-2013","Class I","AlboGraft Knitted with Collagen, Straight 40x07 Catalog Number: AMC4007 AlboGraft Vascular Grafts are made of synthetic material and designed to replace sections of damaged or malfunctioning arteries.","Lot number/Expiration Date 56890A 2015-04",,"1 unit","Blood blushing/leaking from the surface of the graft after implantation",6/17/2013,"06/17/2013",7/31/2013,"07/31/2013"
"Devices",65553,"Ongoing","LeMaitre Vascular, Inc.","Burlington","MA","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Worldwide distribution: USA including PA and countries of: BRAZIL, BULGARIA, FRANCE, GEORGIA, GERMANY, GREECE, ITALY, LEBANON, NETHERLAND, POLAND, SPAIN, and TURKEY.","Z-1755-2013","Class I","AlboGraft Knitted with Collagen, Straight 15x06 Catalog Number: AMC1506 AlboGraft Vascular Grafts are made of synthetic material and designed to replace sections of damaged or malfunctioning arteries. ","Lot number/Expiration Date 56890A 2015-04",,"2 units","Blood blushing/leaking from the surface of the graft after implantation",6/17/2013,"06/17/2013",7/31/2013,"07/31/2013"
"Devices",65554,"Completed","DeRoyal Industries Inc","Powell","TN","US","Voluntary: Firm Initiated","E-Mail","USA Nationwide Distribution in the state of PA","Z-1692-2013","Class II","GEO-MED ORTHO TOTAL JOINT TRACECART(R), REF 53-1831.07, Rx Only, NON-STERILE Product Usage: general surgical","Serial Numbers: 25405311, 25405485, 25556398, 25866038, 25920479, 25969803, 26040887, 26092011, 26092089, 26109451, 26198457, 26262324, 26330892, 26394079, 26568438, 26637085, 26695568, 26938574, 26942371, 26946478, 27751648, 27860730, 27905871, 27915366 ",".","87 units","DeRoyal recalled kits that contained Stryker togas which were recalled for a potential problem with sterilization. ",5/30/2013,"05/30/2013",7/17/2013,"07/17/2013"
"Drugs",65555,"Ongoing","Gilead Sciences, Inc.","Foster City","CA","US","Voluntary: Firm Initiated","Letter","Foreign distribution only to France, Italy, Switzerland, Portugal, Denmark,Turkey, Ireland, Norway, Malta, UK, Greece, Belgium, Austria, Germany, India, Hong Kong, Israel, Saudi Arabia, Thailand, UAE, Singapore, Ecuador, Oman, El Salvador, MCF Holland, MSF, France, Ethiopia, Egypt, Argentina, Chile, Brazil, Spain, Finland, Sweden.","D-821-2013","Class II","AmBisome (amphotericin B) liposome for Injection, 50 mg, For Intravenous Infusion Only, Single-Use Vial, Rx Only, Marketed by: Astellas Pharma US, Inc., Northbrook, IL 60062, Manufactured by: Gilead Sciences, Inc., San Dimas, CA 91773, NDC 0469-3051-30.","Lot #: 042262AD, 042262AD1, 042263AD, 042263AD1, 042264AD, 042265AD, 042265AD1, 042265AD2, Exp 06/2015; 42269AK, 042270AD, 042270AD1, 042270AD3, 042270AD4, 042273AD, Exp 07/2015 and 07/2016 (Germany only); 042285AD, Exp 08/2015 and 8/2016 (UK only); 042293AA, 042293AE, 042293AK, 042298AD, Exp 09/2015; 0422A6AD, Exp 10/15 (for Finland, Greece, Turkey) and Exp10/2016 (for Sweden, UK, Lebanon), 0422B0AD, Exp 10/2015 (for Turkey, Netherland, France), and Exp 10/2016 (for Poland), 0422B0AD1, Exp 10/2015, 0422C1AA, 042304AD, Exp 01/2016 (Spain), and Exp 01/2017 (for Germany, Switzerland), 042304AD1, 042311AD, Exp 01/2016, and Exp 01/2017 (France, UK). ",,"478,352 vials","Lack of Sterility Assurance; During a routine simulation of the manufacturing of AmBisome, a bacterial contamination was detected in some media fill units. No contaminated batches have actually been identified in the finished product, but there is a possibility of contamination.",6/20/2013,"06/20/2013",7/31/2013,"07/31/2013"
"Devices",65556,"Ongoing","Synthes USA HQ, Inc.","West Chester","PA","US","Voluntary: Firm Initiated","Letter","Nationwide Distribution including the states of AK. AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MD, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, RI SC, SD, TN, TX, UT, VA, VT, WA WI and WV.","Z-2057-2013","Class II","Synthes 2.4mm VA-LCP Two Column Volar Distal Radius Plate and Torque limiting attachment, 1.2Nm Synthes VA-LCP Distal Radius System is intended for fixation of complex intra- and extra-articular fractures and osteotomies of the distal radius and other small bones. ","Part number J8301-F",,"119, 891","The firm is initiating a Field Safety Correction for the labeling of the 2.4mm VA-LCP Two Column Volar Distal Radius Plate and 1.2 Nm Torque Limiting Attachment. The US Technique guide lists 1.2Nm TLA as an option for use with the 2.4mm Variable Angle LCP (VA-LCP) Two-Column (Standard & Narrow) Volar Distal Radius Plate. The potential exists for the VA locking screw to be driven through the 2.4mm VA-LCP Two Column Volar Distal Radius Plate when used with a 1.2Nm Torque Limiting Attachment. If a screw passes through the VA-LCP plate, additional medical intervention during the index procedure could be needed.",5/31/2013,"05/31/2013",9/4/2013,"09/04/2013"
"Food",65557,"Ongoing","Price Chopper Golub Corperisable Warehouse","Schenectady","NY","US","Voluntary: Firm Initiated","E-Mail","Price Chopper stores in NY, NH, MA, VT, PA and CT.","F-1747-2013","Class II","Jacqueline's GOURMET COOKIES Almond Bursts COOKIES, Net Wt. 11 oz (8 units total) packed in clear plastic with white labeling----Shelf life is 12 months frozen and 7 days after baked. ","Store Item No: 3552153, UPC: 4173522011 Lot numbers: PB18353-12, PB19036-1, PB19036-2, PB19036-3, PB19036-4, PB19036-5, PB19036-6, PB17576-6, PB18257-10, PB18257-8, PB18777-1, PB18777-2, PB18777-3",,"103,032 cookies packed into 12,879 11 oz packages (10,368 cookies held in stock @ Jacqueline's Gourmet) ","Undeclared Milk allergen",6/21/2013,"06/21/2013",7/31/2013,"07/31/2013"
"Food",65557,"Ongoing","Price Chopper Golub Corperisable Warehouse","Schenectady","NY","US","Voluntary: Firm Initiated","E-Mail","Price Chopper stores in NY, NH, MA, VT, PA and CT.","F-1749-2013","Class II","Jacqueline's GOURMET COOKIES Raspberry Burst Cookies, Net Wt. 11 oz (8 units in total) packed in clear plastic with white labeling---Shelf life is 12 months frozen and 7 days after baked. ","Store Item Code: 3552393, UPC:4173522009 Lot Numbers: PB18363-4, PB18363-5, PB18363-6, PB18363-7, PB18363-8, PB18363-9, PB18363-15, PB18363-16, PB17833-3, PB18325-3, PB20781-3, PB20781-4, PB20781-5, PB20781-6",,"112, 536 cookies packaged into 14,067 11 oz packages","Undeclared Milk allergen",6/21/2013,"06/21/2013",7/31/2013,"07/31/2013"
"Food",65557,"Ongoing","Price Chopper Golub Corperisable Warehouse","Schenectady","NY","US","Voluntary: Firm Initiated","E-Mail","Price Chopper stores in NY, NH, MA, VT, PA and CT.","F-1748-2013","Class II","Jacqueline's GOURMET COOKIES Brownie Burst Cookies, Net Wt. 11 oz (8 units in total) packed in clear plastic with white labeling--Shelf life is 12 months frozen and 7 days after baked. ","Store Item No: 3552273, UPC: 4173522010 Lot numbers: PB18906-10, PB18906-11, PB18906-12, PB18906-9, PB18906-3, PB18906-4, PB18906-5, PB18906-6, PB18905-10, PB18905-11, PB18905-12, PB18905-2, PB18905-3, PB20908-5, PB20908-6",,"112,320 cookes packaged into 14,040 11 oz packages","Undeclared Milk allergen",6/21/2013,"06/21/2013",7/31/2013,"07/31/2013"
"Devices",65558,"Ongoing","Staar Surgical Co.","Monrovia","CA","US","Voluntary: Firm Initiated","Letter","Nationwide distribution: USA including states of: AL,AZ, CA, CO, CT, FL, GA, HI, KY, IA, IL, IN, LA, MA, MI, MN, MO, MS, NC, NE, NH, NJ, NM, NV, NY, OH, PA, SC, TN, TX, UT, VA, WI, and WV.","Z-1746-2013","Class II","nanoFLEX CC4204A Intraocular Lens Correct aphakia in persons 60 years of age or older in whom a cataractous lens has been removed by cataract extraction. The IOL is to be implanted in the posterior chamber and in the capsular bag through a tearfree capsulorhexis.","Serial Numbers: B377007 B377125 B377343 B377522 B377622 B377914 B378040 B378215 B377008 B377126 B377347 B377526 B377627 B377915 B378041 B378216 B377009 B377130 B377348 B377531 B377632 B377918 B378042 B378217 B377010 B377131 B377349 B377532 B377635 B377920 B378043 B378218 B377013 B377142 B377350 B377536 B377640 B377921 B378051 B378219 B377016 B377151 B377352 B377538 B377643 B377923 B378053 B378220 B377020 B377153 B377353 B377539 B377650 B377926 B378057 B378222 B377024 B377154 B377354 B377541 B377651 B377936 B378058 B378223 B377025 B377158 B377355 B377542 B377655 B377940 B378059 B378225 B377026 B377161 B377356 B377543 B377660 B377942 B378062 B378227 B377029 B377165 B377357 B377544 B377669 B377943 B378063 B378228 B377030 B377167 B377358 B377548 B377678 B377944 B378065 B378231 B377032 B377168 B377359 B377550 B377681 B377945 B378067 B378234 B377034 B377171 B377360 B377551 B377686 B377946 B378068 B378235 B377035 B377172 B377361 B377552 B377687 B377950 B378070 B378236 B377036 B377255 B377362 B377553 B377689 B377959 B378071 B378239 B377037 B377258 B377363 B377554 B377690 B377960 B378072 B378241 B377038 B377259 B377366 B377555 B377691 B377963 B378075 B378242 B377040 B377262 B377367 B377557 B377692 B377964 B378076 B378248 B377041 B377263 B377368 B377558 B377693 B377971 B378077 B378255 B377042 B377264 B377369 B377559 B377700 B377972 B378081 B378257 B377043 B377267 B377370 B377560 B377706 B377974 B378082 B378258 B377045 B377270 B377371 B377561 B377707 B377975 B378083 B378259 B377049 B377273 B377372 B377562 B377713 B377979 B378086 B378263 B377054 B377276 B377374 B377563 B377718 B377983 B378087 B378264 B377057 B377278 B377376 B377564 B377721 B377988 B378165 B378265 B377061 B377285 B377377 B377567 B377727 B377991 B378171 B378267 B377062 B377288 B377378 B377569 B377730 B377993 B378172 B378268 B377065 B377290 B377383 B377570 B377741 B377998 B378173 B378269 B377068 B377291 B377384 B377571 B377744 B377999 B378175 B378271 B377070 B377297 B377386 B377572 B377745 B378000 B378177 B378274 B377074 B377298 B377388 B377573 B377746 B3780",".","3,361 units total","STAAR Surgical Company is recalling a limited number of nanoFLEX CC4204A and Afinity CQ2015A intraocular lenses due to the potential presence of glass particles in the storage vial.",6/10/2013,"06/10/2013",7/24/2013,"07/24/2013"
"Devices",65558,"Ongoing","Staar Surgical Co.","Monrovia","CA","US","Voluntary: Firm Initiated","Letter","Nationwide distribution: USA including states of: AL,AZ, CA, CO, CT, FL, GA, HI, KY, IA, IL, IN, LA, MA, MI, MN, MO, MS, NC, NE, NH, NJ, NM, NV, NY, OH, PA, SC, TN, TX, UT, VA, WI, and WV.","Z-1747-2013","Class II","Afinity CQ2015A Intraocular Lens The visual correction of aphakia in persons 60 years of age or older in whom a cataractous lens has been removed by cataract extraction.","Serial Numbers: B377178 B377469 B377877 B378928 B379032 B379638 B380197 B380796 B377192 B377473 B377879 B378940 B379048 B379643 B380200 B380800 B377193 B377480 B377880 B378945 B379062 B379645 B380206 B380801 B377194 B377481 B377883 B378946 B379063 B379646 B380208 B380803 B377195 B377482 B377885 B378947 B379066 B379650 B380214 B380807 B377196 B377485 B377887 B378949 B379093 B379652 B380227 B380816 B377197 B377487 B377888 B378951 B379095 B379653 B380230 B381000 B377200 B377488 B377889 B378953 B379096 B379660 B380235 B381001 B377205 B377490 B377890 B378954 B379099 B379661 B380245 B381009 B377208 B377491 B377894 B378955 B379100 B380060 B380246 B381011 B377211 B377493 B378097 B378956 B379101 B380070 B380251 B381012 B377213 B377495 B378099 B378957 B379103 B380071 B380257 B381014 B377214 B377496 B378107 B378958 B379104 B380072 B380261 B381017 B377216 B377497 B378110 B378959 B379106 B380073 B380265 B381019 B377217 B377804 B378111 B378960 B379107 B380078 B380270 B381021 B377232 B377812 B378112 B378961 B379110 B380081 B380271 B381022 B377236 B377816 B378122 B378963 B379111 B380084 B380272 B381024 B377238 B377819 B378123 B378964 B379112 B380085 B380273 B381026 B377239 B377820 B378124 B378965 B379114 B380087 B380274 B381028 B377241 B377821 B378126 B378967 B379115 B380088 B380280 B381029 B377243 B377822 B378130 B378968 B379117 B380091 B380281 B381030 B377245 B377824 B378131 B378969 B379119 B380092 B380283 B381032 B377248 B377825 B378132 B378970 B379121 B380093 B380285 B381034 B377249 B377827 B378135 B378972 B379123 B380094 B380286 B381036 B377253 B377828 B378137 B378973 B379125 B380097 B380287 B381037 B377423 B377829 B378144 B378976 B379129 B380098 B380288 B381038 B377426 B377830 B378145 B378979 B379131 B380102 B380290 B381039 B377428 B377831 B378148 B378981 B379132 B380106 B380291 B381040 B377429 B377834 B378156 B378982 B379133 B380108 B380519 B381041 B377432 B377839 B378160 B378986 B379134 B380118 B380529 B381051 B377435 B377842 B378899 B378990 B379135 B380125 B380548 B381052 B377437 B377843 B378901 B378991 B379141 B3801",".","3,361 units total","STAAR Surgical Company is recalling a limited number of nanoFLEX CC4204A and Afinity CQ2015A intraocular lenses due to the potential presence of glass particles in the storage vial.",6/10/2013,"06/10/2013",7/24/2013,"07/24/2013"
"Drugs",65559,"Ongoing","Medicis Pharmaceutical Corp","Scottsdale","AZ","US","Voluntary: Firm Initiated","Telephone","Nationwide, Great Britain, Mexico, Russia and The Ukraine.","D-916-2013","Class II","CLENZIderm M.D. Acne Therapeutic System Normal to Oily Skin kit, Distributed by OMP, Inc., Long Beach, CA 90806, Kit is comprised of: Daily Care Foaming Cleanser (Salicylic Acid 2%) NDC 62032-111; Pore Therapy (Salicylic Acid 2%) NDC 62032-110 and Therapeutic Lotion (Benzoyl Peroxide 5%) NDC 562032-113). Product under recall is the Pore Therapy (Salicylic Acid 2%), NDC 62032-110.","Lot #11L1074, Exp 07/14 ",".","2491 Kits","cGMP Deviations; during the production process, CLENZIderm M.D. Daily Foam Cleanser was filled into some bottles labeled as CLENZIderm M.D. Pore Therapy",5/1/2013,"05/01/2013",8/28/2013,"08/28/2013"
"Devices",65560,"Ongoing","Synthes USA HQ, Inc.","West Chester","PA","US","Voluntary: Firm Initiated","Letter","Nationwide Distribution.","Z-1952-2013","Class II","Synthes Flexible Medullary Reamer. Intended to be used to facilitate the preparation of the intramedullary cavity.","All lots with part number 359.106, 359.107, 359.108, 359.109, 359.110, 359.111, 359.112, 359.113, 359.114, 359.115",,"13,050","Due to the coiled design for this product, the product is difficult to clean and the potential for corrosion on the device exists. The potential for harm exists if there is an introduction of foreign material at the operative site originating from the presence of corrosion and/or the retained undefined material that could not be adequately cleaned.",6/11/2013,"06/11/2013",8/21/2013,"08/21/2013"
"Devices",65561,"Ongoing","Synthes USA HQ, Inc.","West Chester","PA","US","Voluntary: Firm Initiated","Visit","US Nationwide Distribution including the states of MA, TX, MN, SC, UT, VA, and NY.","Z-1745-2013","Class II","Multi Vector Distractor Pin Holding Clamp, limited bone stock The holding clamp is part of the Multi Vector Distractor which cis used for mandibular bone lengthening, including conditions such as congenital mandibular deficiencies or post-traumatic defects. The Multi Vector Distractor can be utilized to perform bone transport procedures as an alternative to bone grafts and free flaps."," Titanium Multi Vector Distractor Pin Holding Clamp, body, limited bone stock Part # 487.941 with lot numbers: 3769720, 3779569, 3788731, 3794434, 7806093, 7823463 and Titanium Multi Vector Distractor Pin Holding Clamp, ramus, limited bone stock Part # 487.942 with lot numbers: 3769706, 3779571, 3788741, 7806096, 7823464.",".","121","Synthes is initiating a voluntary Medical Device removal for specified part numbers and lot numbers of the Mutis Vector Distractor Pin Holding clamp, limited bone stock. The firm received complaints that the clamp and nut construct would not engage the distractor arm threads and subsequently bind. It is not likely that a serious adverse event will result due to a nonconforming clamp, however there is a remote potential that additional intervention would be required due to a non-functioning clamp. ",5/31/2013,"05/31/2013",7/24/2013,"07/24/2013"
"Devices",65563,"Ongoing","Synthes USA HQ, Inc.","West Chester","PA","US","Voluntary: Firm Initiated","Letter","Nationwide Distribution.","Z-1935-2013","Class II","5.0mm Unit steel rod, pedicle screw spinal system. Intended to provide immobilization and stabilization of spinal segments in skeletally mature patients. ","ALL LOTS of part numbers 298.269 and 298.278. Lot numbers were listed as: 4729951, 4841209, 4923651, 4923652, 4987688, 4987750, 5350635, 2002330, 3000595, 4729962, 4835378, 4856252, 4919165, 4923660, 4987686, 4987776, 5153851.",,"218","DePuy Synthes has issued a Medical Device Correction notice for the 5.0mm Stainless Steel rods. This product was produced using a finishing process not identified as part of the manufacturing specification. No adverse event reports associated with the use of this product were received, and an extensive engineering and medical safety review concluded that the product poses no incremental risk to the patient outside of the current instructions for Use. The firm has not become aware of any impact to the patient due to the finishing found on the stainless steel rods subject to this notice. ",6/5/2013,"06/05/2013",8/21/2013,"08/21/2013"
"Devices",65564,"Ongoing","CareFusion 303, Inc.","San Diego","CA","US","Voluntary: Firm Initiated","Letter","Worldwide distribution: US (nationwide) and countries of: Australia, Canada and Europe.","Z-1835-2013","Class I","Alaris PC unit, model 8015, with version 9.12-Keyboard Processor and logic board assembly part number TC10006584. The Alaris PC Unit is the main user interface unit and power supply of the Alaris System, a modular system to be used with Alaris System modules intended for use in todays growing professional healthcare environment for facilities that utilize infusion and/or monitoring devices.","1005435 10038007 1300550 3894703 1003149 19995706 3895887 19995118 1022500 1257000 1010235 3894799 1264612 1029800 10032389 3894714 3894796 1039450 19995610 3894886 1058150 1129100 1003197 1065900 3894701 10063252 1610200 1074200 3894708 10142044 1296030 1020387 3894811 1083900 10115320 1101500 1102400 1101601 10038966 19995620 3894841 1123000 1135600 1137240 1353400 3894860 1547000 1008565 1186900 6169100 10008460 3894844 1155500 3894711 10032361 10166465 3894702 10046069 10037661 10037647 3894834 3894836 10034261 1297400 1302600 1053000 1317801 3894817 3894797 10163092 10053161 1012161 3895854 10046578 1369040 1005333 1375900 10001956 3894734 3894789 3894833 10047157 1403100 1408700 10010196 3894892 3894765 1433251 1009496 1446000 1438800 1865900 1911872 10010570 19996156 10033408 1589480 1453703 1466600 1453702 6273300 10011620 1470203 1477201 1765300 1025650 10037131 19995384 1915200 1470204 1315403 10044246 1470001 1470202 19995746 6129700 1726300 1505700 10063253 10037742 1131700 10037723 4513601 1520101 1001799 10010451 4538200 10122836 1001783 1553400 1220200 3894705 1907800 1000456 6572500 19996529 10038213 3894830 1843701 10165568 1579040 10035744 10060127 3894819 3895895 1027700 1623400 1012793 10149088 3894849 1492500 1719500 10033426 1677100 1697501 1703300 6237701 1716400 1018653 10011474 1725100 1724300 1252400 6598300 1738700 6606300 10002540 19995700 10047163 1793108 3894718 1797801 10038591 1016746 1079000 1442503 19995670 10032641 1043750 1015768 1812600 1813200 1833900 1842600 1846801 1838401 1027503 1846000 10046982 10049664 10049674 10042072 10158492 10040131 1845700 3872400 3894825 3895883 3894801 3880600 3894722 3894716 3894723 3895875 3888400 6840950 10036536 3894870 1908600 1037000 1012361 19995045 10165422 10165005 10005354 10011455 1933600 3894735 1944700 980 500 101",".","26,564 total units (26,220 units for US)","CareFusion is recalling the Alaris PC units model 8015 (PC unit), version 9.12, because it is operating at an incorrect voltage and it could potentially experience a loss of communication between the PC Unit main Processor and Keyboard Processor.",6/17/2013,"06/17/2013",8/14/2013,"08/14/2013"
"Devices",65565,"Ongoing","Physio Control, Inc.","Redmond","WA","US","Voluntary: Firm Initiated","Letter","Worldwide distribution: US (nationwide) including states of: IL, MA, NC, ND, NY, PA, RI, TX, WA, and WI; and country of: Canada.","Z-1773-2013","Class II","The LIFEPAK 500 Automated External Defibrillator is a semi-automatic defibrillator that uses a patented Shock Advisory System. This software algorithm analyzes the patient's electrocardiographic (ECG) rhythm and indicates whether or not it detects a shockable rhythm. The LIFEPAK 500 AED is intended for use by personnel who are authorized by a physician/medical director and is intended for use in the pre-hospital and workplace and community environments.","PART NUMBERS: 3011790-001568, 3011790-001574, 3011790-001627, 3011790-001634, and 3011790-001650. SERIAL NUMBERS OUTSIDE the US: 41232265, 41232267, 41232269, 41232270, 41232271, 41232272, 41238207, 41238208, 41301145, 41301370, 41301371, 41301372, 41301373, and 41301374. SERIAL NUMBERS IN THE US: 41134905, 41134906, 41134907, 41135982, 41135983, 41135984, 41135991, 41135992, 41135993, 41135994, 41135995, 41135996, 41135997, 41135998, 41135999, 41136000, 41136001, 41136002, 41136003, 41136004, 41136005, 41136006, 41136007, 41136008, 41136009, 41136010, 41136011, 41136012, 41136013, 41136014, 41136015, 41136016, 41136017, 41136018, 41136019, 41136020, 41136021, 41136022, 41136023, 41136024, 41136025, 41136026, 41136027, 41136028, 41136029, 41136030, 41136031, 41136033, 41136034, 41136035, 41136036, 41136037, 41136038, 41136039, 41136040, 41136060, 41136061, 41136062, 41136063, 41136064, 41136065, 41136066, 41136067, 41136068, 41136069, 41136070, 41136071, 41136072, 41136073, 41136074, 41136075, 41136076, 41136077, 41136078, 41136079, 41136092, 41136093, 41136094, 41142873, 41145359, 41145360, 41145361, 41145362, 41145363, 41145364, 41145365, 41145366, 41145367, 41145368, 41145369, 41145370, 41145371, 41145372, 41145373, 41145374, 41145375, 41145376, 41145377, 41145378, 41164115, 41232002, 41232003, 41232004, 41232005, 41232249, 41232250, 41232251, 41232252, 41232253, 41232254, 41232255, 41232256, 41232257, 41232258, 41232259, 41232260, 41232554, 41239182, 41239183, 41239184, 41239185, 41239186, 41239187, 41239188, and 41239189. ",,"139 total (125 units in the US and 14 units outside US)","The LIFEPAK 500 Automated External Defibrillator (AED) could be susceptible to malfunction due to an assembly error. If affected, the malfunction would be the result of internal shorting on a printed circuit board assembly and could render the device inoperable.",6/12/2013,"06/12/2013",7/31/2013,"07/31/2013"
"Food",65566,"Ongoing","Kroger Co","Cincinnati","OH","US","Voluntary: Firm Initiated","E-Mail","The affected product was only distributed in the states of WA and OR.","F-1718-2013","Class I","QFC Chicken Pesto Panini wrapped in polywrap packaging, 10.32 oz. in size, included with five (5) other types of sandwiches in a 6-count ''variety pack'' case. ","The affected product has a sell by date of 06/22/13 and a UPC code of 1111039114. ",".","235 sandwiches","The paninis may contain soy and egg, which are allergens. ",6/22/2013,"06/22/2013",7/24/2013,"07/24/2013"
"Biologics",65567,"Terminated","Plasma Biological Services","Owensboro","KY","US","Voluntary: Firm Initiated","E-Mail","California","B-2301-13","Class III","Source Plasma","BQ146535; BQ146340; BQ146127; BQ145624; BQ145539; BQ144250; BQ143866; BQ143646; ",,"8","Blood products, collected from an ineligible donor, were distributed",4/16/2013,"04/16/2013",9/25/2013,"09/25/2013"
"Devices",65568,"Ongoing","Exactech, Inc.","Gainesville","FL","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","US Distribution including the states of AR, CA, FL, NJ, NY, OK, and TX","Z-1832-2013","Class II","Exactech Articulated Driver A nonpowered hand-held device intended for medical purposes to manipulate tissue, or for use with other devices in orthopedic surgery.","Lot #: 52667001 Catalog #: 181-00-04",,"57","When torque is applied to the Articulated Driver at the maximum angle, the cross pin may shift out of position, potentially leading to disassembly of the instrument.",5/30/2013,"05/30/2013",8/7/2013,"08/07/2013"
"Veterinary",65569,"Ongoing","Pet Brands Inc","Columbus","OH","US","Voluntary: Firm Initiated","E-Mail","Product was shipped to the following states: AL, AR, AZ, CA, CO, DE, FL, GA, IA, IL, IN, KS, KY, LA, MD, MI, MO, MS, NC, NE, NJ, NM, NY, OH, OK, PA, SC, SD, TN, TX, UT, VA, VT, WI & WV.","V-036-2014","Class II","Everpet Real Chicken Chicken Chips Dog Treats, packaged in flexible plastic bags, 3.5 oz. per bag, MADE IN CHINA DISTRIBUTED BY DOLGENCORP, INC. 100 MISSION RIDGE GOODLETTSVILLE, TN 37072 UPC 8 10633 01177 5","Lot #111108EVPRAW013 - Best Buy Date: 2/5/2013 and Lot #120752EVPRAW013 - Best Buy Date: 8/27/2014. ",".","377,628/3.5 oz bags","The New York State Department of Agriculture & Markets (NYSDAM) found trace amounts of non-approved antibiotic residue in some of the dog treat samples that they tested. ",5/23/2013,"05/23/2013",12/26/2013,"12/26/2013"
"Food",65570,"Ongoing","Torn & Glasser Inc.","East Rancho Dominguez","CA","US","Voluntary: Firm Initiated","E-Mail","CA, AZ, and HI.","F-1656-2013","Class I","Torn and Glasser Brand Roasted & Salted Natural Pistachios, 8 oz. 24/8oz Case. Labeling reads in part:''TORN & GLASSER***ROASTED & SALTED NATURAL PISTACHIOS***NET WT. 8 OZ***Packed by:Torn & Glasser, Los Angeles, CA***''","Best By date:12/05/2012, Julian date 3402 UPC: 0 72488 15002 7",".","3 cases","Pistachios have the potential to be contaminated with Salmonella.",6/7/2013,"06/07/2013",7/17/2013,"07/17/2013"
"Food",65570,"Ongoing","Torn & Glasser Inc.","East Rancho Dominguez","CA","US","Voluntary: Firm Initiated","E-Mail","CA, AZ, and HI.","F-1657-2013","Class I","Roasted and Salted Pistachios packed under the following brand names and packaging: Sprouts Brand Roasted & Salted Pistachios, various weights. into 12 individual plastic bags with various weights per unit, then packaged into 10 lbs cardboard box. . Sun Harvest Brand Roasted & Salted Pistachios, 12 oz., packaged in plastic bag then packed into cardboard case. 24/12oz. Hilo Brand Roasted & Salted Pistachios, 16 oz., plastic bags, packed into 12/1lb case. Individual 1 lb plastic bag labeling. Outer case #H460-084; 12/1 LB (454g).","Sprouts - Best By dates:02/20/2013, 02/25/13; Julian Dates:0513 and 0563; UPC code changes for each package of Sprouts product as it has the price coded, 2 06620 xxxxx x. Sun Harvest - Best By Dates:04/11/2013 & 04/23/2013; Julian Dates:1003 and 1133. Hilo - Best By Date:04/02/2013; Julian Date:0923",".","328 cases","Pistachios have the potential to be contaminated with Salmonella.",6/7/2013,"06/07/2013",7/17/2013,"07/17/2013"
"Food",65571,"Ongoing","Scenic Fruit Co","Gresham","OR","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Product was directly distributed to distribution centers in California, Colorado, Connecticut, Florida, Georgia, Indiana, Iowa, New Hampshire, Pennsylvania, Rhode Island, Texas, and Washington.","F-0702-2014","Class I","Woodstock Frozen Organic Pomegranate Kernels are sold in 8 oz. (227 gram) re-sealable plastic pouches with the UPC 0 42563 01628 9. The product is labeled in parts: ''***WOODSTOCK***ORGANIC POMEGRANATE KERNELS***Juicy Lil' JEWELS***USDA ORGANIC***NET WT. 8 OZ (227g)***KEEP FROZEN***INGREDIENTS: Organic pomegranate kernels***Distributed by Woodstock, 313 Iron Horse Way Providence, RI 02908***''.","Recalled Lot codes and Best By Dates are: C 0129 (A, B, or C) 035 with a best by date of 02/04/2015. C 0388 (A, B, or C) 087 with a best by date of 03/28/2015. C 0490 (A, B, or C) 109 with a best by date of 04/19/2015. Code is interpreted as: C=Year; Year: 2012=B, 2013=C, 2014=D; 0129=Lot; C=Line number; 035=Julian date ; ",".","5,091 cases/12 bags/8 oz.","Woodstock Frozen Organic Pomegranate Kernels, 8 oz. pouches, are recalled based on epidemiological evidence that they may to be contaminated with hepatitis A.",6/26/2013,"06/26/2013",12/11/2013,"12/11/2013"
"Devices",65572,"Ongoing","Ortho-Clinical Diagnostics","Rochester","NY","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution - USA (nationwide) including AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NY, OH, OK, OR, PA, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV, and WY including Puerto Rico and Internationally to Australia, Brazil, Canada, Chile, China, Colombia, India, Japan, Mexico, Panama, Singapore, Venezuela, England, Germany, France, Italy, and Spain.","Z-0293-2014","Class II","VITROS Chemistry Products AcP Slides, 90 slides/pack; catalog number 8168122 VITROS Chemistry Products AcP Slides quantitatively measure acid phosphatase (AcP) activity in serum and plasma using VITROS 950/5,1 FS and 4600 Chemistry Systems and the VITROS 5600 Integrated System.","Multiple lots affected, with expiry dates through 22-Mar-2015",,"544 units (48 domestically & 496 internationally)","Ortho Clinical Diagnostics is recalling Slide Dispense cartridges used with some VITROS Chemistry Product Slides due to slide dispense issues. ",6/12/2013,"06/12/2013",11/27/2013,"11/27/2013"
"Devices",65572,"Ongoing","Ortho-Clinical Diagnostics","Rochester","NY","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution - USA (nationwide) including AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NY, OH, OK, OR, PA, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV, and WY including Puerto Rico and Internationally to Australia, Brazil, Canada, Chile, China, Colombia, India, Japan, Mexico, Panama, Singapore, Venezuela, England, Germany, France, Italy, and Spain.","Z-0302-2014","Class II","VITROS Chemistry Products Ca Slides packaged as 300 slides/pack catalog number 1450261 VITROS Ca Slides quantitatively measure calcium (Ca) concentration in serum, plasma, and urine using VITROS 250/350/950/5,1 FS and 4600 Chemistry Systems and the VITROS 5600 Integrated System.","Multiple lots affected, with expiry dates through 22-Mar-2015",,"231,112 units (133,173 units domestically & 97,939 units internationally)","Ortho Clinical Diagnostics is recalling Slide Dispense cartridges used with some VITROS Chemistry Product Slides due to slide dispense issues. ",6/12/2013,"06/12/2013",11/27/2013,"11/27/2013"
"Devices",65572,"Ongoing","Ortho-Clinical Diagnostics","Rochester","NY","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution - USA (nationwide) including AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NY, OH, OK, OR, PA, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV, and WY including Puerto Rico and Internationally to Australia, Brazil, Canada, Chile, China, Colombia, India, Japan, Mexico, Panama, Singapore, Venezuela, England, Germany, France, Italy, and Spain.","Z-0326-2014","Class II","VITROS Chemistry Products TRIG Slides packaged as 300 slides/pack catalog number 1336544 and packaged as 90 slides/pack catalog number 8329930 VITROS TRIG Slides quantitatively measure triglyceride (TRIG) concentration in serum and plasma using VITROS 250/350/950/5,1 FS and 4600 Chemistry Systems and the VITROS 5600 Integrated System.","Multiple lots affected, with expiry dates through 22-Mar-2015",,"127,662 units (42,487 units domestically & 84,906 units internationally)","Ortho Clinical Diagnostics is recalling Slide Dispense cartridges used with some VITROS Chemistry Product Slides due to slide dispense issues. ",6/12/2013,"06/12/2013",11/27/2013,"11/27/2013"
"Devices",65572,"Ongoing","Ortho-Clinical Diagnostics","Rochester","NY","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution - USA (nationwide) including AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NY, OH, OK, OR, PA, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV, and WY including Puerto Rico and Internationally to Australia, Brazil, Canada, Chile, China, Colombia, India, Japan, Mexico, Panama, Singapore, Venezuela, England, Germany, France, Italy, and Spain.","Z-0294-2014","Class II","VITROS Chemistry Products ALB Slides, 90 slides/pack; catalog number 1988211 VITROS ALB Slides quantitatively measure (ALB) concentration in serum and plasma using VITROS 250/350/950/5,1 FS and 4600 Chemistry Systems and the VITROS 5600 Integrated System.","Multiple lots affected, with expiry dates through 22-Mar-2015",,"16583 units (3073 domestically & 13510 internationally)","Ortho Clinical Diagnostics is recalling Slide Dispense cartridges used with some VITROS Chemistry Product Slides due to slide dispense issues. ",6/12/2013,"06/12/2013",11/27/2013,"11/27/2013"
"Devices",65572,"Ongoing","Ortho-Clinical Diagnostics","Rochester","NY","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution - USA (nationwide) including AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NY, OH, OK, OR, PA, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV, and WY including Puerto Rico and Internationally to Australia, Brazil, Canada, Chile, China, Colombia, India, Japan, Mexico, Panama, Singapore, Venezuela, England, Germany, France, Italy, and Spain.","Z-0299-2014","Class II","VITROS Chemistry Products AST Slides packaged as 300 slides/pack catalog number 8433815 VITROS AST Slides quantitatively measure aspartate aminotransferase (AST) activity in serum and plasma using VITROS 250/350/950/5,1 FS and 4600 Chemistry Systems and the VITROS 5600 Integrated System","Multiple lots affected, with expiry dates through 22-Mar-2015",,"197,552 units (88,537 units domestically & 109,015 units internationally)","Ortho Clinical Diagnostics is recalling Slide Dispense cartridges used with some VITROS Chemistry Product Slides due to slide dispense issues. ",6/12/2013,"06/12/2013",11/27/2013,"11/27/2013"
"Devices",65572,"Ongoing","Ortho-Clinical Diagnostics","Rochester","NY","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution - USA (nationwide) including AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NY, OH, OK, OR, PA, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV, and WY including Puerto Rico and Internationally to Australia, Brazil, Canada, Chile, China, Colombia, India, Japan, Mexico, Panama, Singapore, Venezuela, England, Germany, France, Italy, and Spain.","Z-0296-2014","Class II","VITROS Chemistry Products ALKP Slides, 300 slides/pack; catalog number 1053180 VITROS ALKP Slides quantitatively measure alkaline phosphatase (ALKP) activity in serum and plasma using VITROS 250/350/950/5,1 FS and 4600 Chemistry Systems and the VITROS 5600 Integrated System.","Multiple lots affected, with expiry dates through 22-Mar-2015",,"183267 units (89415 units domestically & 93852 units internationally)","Ortho Clinical Diagnostics is recalling Slide Dispense cartridges used with some VITROS Chemistry Product Slides due to slide dispense issues. ",6/12/2013,"06/12/2013",11/27/2013,"11/27/2013"
"Devices",65572,"Ongoing","Ortho-Clinical Diagnostics","Rochester","NY","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution - USA (nationwide) including AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NY, OH, OK, OR, PA, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV, and WY including Puerto Rico and Internationally to Australia, Brazil, Canada, Chile, China, Colombia, India, Japan, Mexico, Panama, Singapore, Venezuela, England, Germany, France, Italy, and Spain.","Z-0311-2014","Class II","VITROS Chemistry Products dHDL Slides packaged as 300 slides/pack catalog number 6801895 VITROS dHDL Slides quantitatively measure HDL cholesterol (HDLC) concentration in serum and plasma using VITROS 250/350/950/5,1 FS and 4600 Chemistry Systems and the VITROS 5600 Integrated System.","Multiple lots affected, with expiry dates through 22-Mar-2015",,"100.393 units (36,873 units domestically & 63,520 units internationally)","Ortho Clinical Diagnostics is recalling Slide Dispense cartridges used with some VITROS Chemistry Product Slides due to slide dispense issues. ",6/12/2013,"06/12/2013",11/27/2013,"11/27/2013"
"Devices",65572,"Ongoing","Ortho-Clinical Diagnostics","Rochester","NY","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution - USA (nationwide) including AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NY, OH, OK, OR, PA, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV, and WY including Puerto Rico and Internationally to Australia, Brazil, Canada, Chile, China, Colombia, India, Japan, Mexico, Panama, Singapore, Venezuela, England, Germany, France, Italy, and Spain.","Z-0305-2014","Class II","VITROS Chemistry Products CK Slides packaged as 300 slides/pack catalog number 8479396 and packaged as 90 slides/pack catalog number 8478034 VITROS CK Slides quantitatively measure creatine kinase (CK) activity in serum and plasma using VITROS 250/350/950/5,1 FS and 4600 Chemistry Systems and the VITROS 5600 Integrated System.","Multiple lots affected, with expiry dates through 22-Mar-2015",,"86,503 units (30,378 units domestically & 56,125 units internationally)","Ortho Clinical Diagnostics is recalling Slide Dispense cartridges used with some VITROS Chemistry Product Slides due to slide dispense issues. ",6/12/2013,"06/12/2013",11/27/2013,"11/27/2013"
"Devices",65572,"Ongoing","Ortho-Clinical Diagnostics","Rochester","NY","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution - USA (nationwide) including AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NY, OH, OK, OR, PA, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV, and WY including Puerto Rico and Internationally to Australia, Brazil, Canada, Chile, China, Colombia, India, Japan, Mexico, Panama, Singapore, Venezuela, England, Germany, France, Italy, and Spain.","Z-0318-2014","Class II","VITROS Chemistry Products Mg Slides packaged as 300 slides/pack catalog number 8255093 and packaged as 90 slides/pack catalog number 1921204 VITROS Mg Slides quantitatively measure magnesium (Mg) concentration in serum, plasma, and urine using VITROS 250/350/950/5,1 FS and 4600 Chemistry Systems and the VITROS 5600 Integrated System.","Multiple lots affected, with expiry dates through 22-Mar-2015",,"101,976 units (39,909 units domestically & 62,067 units internationally)","Ortho Clinical Diagnostics is recalling Slide Dispense cartridges used with some VITROS Chemistry Product Slides due to slide dispense issues. ",6/12/2013,"06/12/2013",11/27/2013,"11/27/2013"
"Devices",65572,"Ongoing","Ortho-Clinical Diagnostics","Rochester","NY","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution - USA (nationwide) including AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NY, OH, OK, OR, PA, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV, and WY including Puerto Rico and Internationally to Australia, Brazil, Canada, Chile, China, Colombia, India, Japan, Mexico, Panama, Singapore, Venezuela, England, Germany, France, Italy, and Spain.","Z-0320-2014","Class II","VITROS Chemistry Products PHOS Slides packaged as 300 slides/pack catalog number 1513209 VITROS PHOS Slides quantitatively measure phosphorus (PHOS) concentration in serum, plasma, and urine using VITROS 250/350/950/5,1 FS and 4600 Chemistry Systems and the VITROS 5600 Integrated System.","Multiple lots affected, with expiry dates through 22-Mar-2015",,"81,382 units (28,256 units domestically & 53,126 units internationally)","Ortho Clinical Diagnostics is recalling Slide Dispense cartridges used with some VITROS Chemistry Product Slides due to slide dispense issues. ",6/12/2013,"06/12/2013",11/27/2013,"11/27/2013"
"Devices",65572,"Ongoing","Ortho-Clinical Diagnostics","Rochester","NY","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution - USA (nationwide) including AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NY, OH, OK, OR, PA, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV, and WY including Puerto Rico and Internationally to Australia, Brazil, Canada, Chile, China, Colombia, India, Japan, Mexico, Panama, Singapore, Venezuela, England, Germany, France, Italy, and Spain.","Z-0319-2014","Class II","VITROS Chemistry Products PHBR Slides packaged as 90 slides/pack catalog number 8221384 VITROS PHBR Slides quantitatively measure phenobarbital (PHBR) concentration in serum and plasma using VITROS 250/350/950/5,1 FS and 4600 Chemistry Systems and the VITROS 5600 Integrated System.","Multiple lots affected, with expiry dates through 22-Mar-2015",,"6,606 units (5,071 units domestically & 1,535 units internationally)","Ortho Clinical Diagnostics is recalling Slide Dispense cartridges used with some VITROS Chemistry Product Slides due to slide dispense issues. ",6/12/2013,"06/12/2013",11/27/2013,"11/27/2013"
"Devices",65572,"Ongoing","Ortho-Clinical Diagnostics","Rochester","NY","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution - USA (nationwide) including AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NY, OH, OK, OR, PA, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV, and WY including Puerto Rico and Internationally to Australia, Brazil, Canada, Chile, China, Colombia, India, Japan, Mexico, Panama, Singapore, Venezuela, England, Germany, France, Italy, and Spain.","Z-0300-2014","Class II","VITROS Chemistry Products BuBc Slides packaged as 300 slides/pack catalog number 8383051 and packaged as 90 slides/pack catalog number 1612365 VITROS BuBc Slides quantitatively measure unconjugated bilirubin (Bu) and conjugated bilirubin (Bc) concentrations in serum and plasma using VITROS 250/350/950/5,1 FS and 4600 Chemistry Systems and the VITROS 5600 Integrated System.","Multiple lots affected, with expiry dates through 22-Mar-2015",,"74,792 units (35,501 units domestically & 60,291 units internationally)","Ortho Clinical Diagnostics is recalling Slide Dispense cartridges used with some VITROS Chemistry Product Slides due to slide dispense issues. ",6/12/2013,"06/12/2013",11/27/2013,"11/27/2013"
"Devices",65572,"Ongoing","Ortho-Clinical Diagnostics","Rochester","NY","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution - USA (nationwide) including AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NY, OH, OK, OR, PA, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV, and WY including Puerto Rico and Internationally to Australia, Brazil, Canada, Chile, China, Colombia, India, Japan, Mexico, Panama, Singapore, Venezuela, England, Germany, France, Italy, and Spain.","Z-0317-2014","Class II","VITROS Chemistry Products LIPA Slides packaged as 300 slides/pack catalog number 1668409 and packaged as 90 slides/pack catalog number 8297749 VITROS LIPA Slides quantitatively measure Lipase (LIPA) activity in serum and plasma using VITROS 250/350/950/5,1 FS and 4600 Chemistry Systems and the VITROS 5600 Integrated System.","Multiple lots affected, with expiry dates through 22-Mar-2015",,"62,039 units (26,765 units domestically & 35,274 units internationally)","Ortho Clinical Diagnostics is recalling Slide Dispense cartridges used with some VITROS Chemistry Product Slides due to slide dispense issues. ",6/12/2013,"06/12/2013",11/27/2013,"11/27/2013"
"Devices",65572,"Ongoing","Ortho-Clinical Diagnostics","Rochester","NY","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution - USA (nationwide) including AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NY, OH, OK, OR, PA, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV, and WY including Puerto Rico and Internationally to Australia, Brazil, Canada, Chile, China, Colombia, India, Japan, Mexico, Panama, Singapore, Venezuela, England, Germany, France, Italy, and Spain.","Z-0303-2014","Class II","VITROS Chemistry Products CHE Slides packaged as 300 slides/pack catalog number 1914605 and packaged as 90 slides/pack catalog number 8004707 VITROS CHE Slides quantitatively measure cholinesterase (CHE) activity in serum and plasma using VITROS 250/350/950/5,1 FS and 4600 Chemistry Systems and the VITROS 5600 Integrated System.","Multiple lots affected, with expiry dates through 22-Mar-2015",,"11,135 units (153 units domestically & 10,982 internationally)","Ortho Clinical Diagnostics is recalling Slide Dispense cartridges used with some VITROS Chemistry Product Slides due to slide dispense issues. ",6/12/2013,"06/12/2013",11/27/2013,"11/27/2013"
"Devices",65572,"Ongoing","Ortho-Clinical Diagnostics","Rochester","NY","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution - USA (nationwide) including AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NY, OH, OK, OR, PA, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV, and WY including Puerto Rico and Internationally to Australia, Brazil, Canada, Chile, China, Colombia, India, Japan, Mexico, Panama, Singapore, Venezuela, England, Germany, France, Italy, and Spain.","Z-0310-2014","Class II","VITROS Chemistry Products DGXN Slides packaged as 90 slides/pack catalog number 8343386 VITROS DGXN Slides quantitatively measure digoxin (DGXN) concentration in serum using VITROS 250/350/950/5,1 FS and 4600 Chemistry Systems and the VITROS 5600 Integrated System.","Multiple lots affected, with expiry dates through 22-Mar-2015",,"24,857 units (17,887 units domestically & 6970 units internationally)","Ortho Clinical Diagnostics is recalling Slide Dispense cartridges used with some VITROS Chemistry Product Slides due to slide dispense issues. ",6/12/2013,"06/12/2013",11/27/2013,"11/27/2013"
"Devices",65572,"Ongoing","Ortho-Clinical Diagnostics","Rochester","NY","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution - USA (nationwide) including AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NY, OH, OK, OR, PA, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV, and WY including Puerto Rico and Internationally to Australia, Brazil, Canada, Chile, China, Colombia, India, Japan, Mexico, Panama, Singapore, Venezuela, England, Germany, France, Italy, and Spain.","Z-0315-2014","Class II","VITROS Chemistry Products LAC Slides packaged as 300 slides/pack catalog number 8433880 and packaged as 90 slides/pack catalog number 8150112 VITROS LAC Slides quantitatively measure lactate (LAC) concentration in plasma using VITROS 250/350/950/5,1 FS and 4600 Chemistry Systems and the VITROS 5600 Integrated System.","Multiple lots affected, with expiry dates through 22-Mar-2015",,"28,633 units (14,634 units domestically & 13,999 units internationally)","Ortho Clinical Diagnostics is recalling Slide Dispense cartridges used with some VITROS Chemistry Product Slides due to slide dispense issues. ",6/12/2013,"06/12/2013",11/27/2013,"11/27/2013"
"Devices",65572,"Ongoing","Ortho-Clinical Diagnostics","Rochester","NY","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution - USA (nationwide) including AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NY, OH, OK, OR, PA, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV, and WY including Puerto Rico and Internationally to Australia, Brazil, Canada, Chile, China, Colombia, India, Japan, Mexico, Panama, Singapore, Venezuela, England, Germany, France, Italy, and Spain.","Z-0312-2014","Class II","VITROS Chemistry Products ECO2 Slides packaged as 300 slides/pack catalog number 8262396 VITROS ECO2 Slides quantitatively measure total carbon dioxide (CO2) concentration in serum and plasma using VITROS 250/350/950/5,1 FS and 4600 Chemistry Systems and the VITROS 5600 Integrated System.","Multiple lots affected, with expiry dates through 22-Mar-2015",,"205,534 units (137,887 units domestically & 67,647 units internationally) ","Ortho Clinical Diagnostics is recalling Slide Dispense cartridges used with some VITROS Chemistry Product Slides due to slide dispense issues. ",6/12/2013,"06/12/2013",11/27/2013,"11/27/2013"
"Devices",65572,"Ongoing","Ortho-Clinical Diagnostics","Rochester","NY","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution - USA (nationwide) including AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NY, OH, OK, OR, PA, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV, and WY including Puerto Rico and Internationally to Australia, Brazil, Canada, Chile, China, Colombia, India, Japan, Mexico, Panama, Singapore, Venezuela, England, Germany, France, Italy, and Spain.","Z-0322-2014","Class II","VITROS Chemistry Products PROT Slides packaged as 90 slides/pack catalog number 8208431 VITROS PROT Slides quantitatively measure protein (PROT) concentration in cerebrospinal fluid using VITROS 250/350/950/5,1 FS and 4600 Chemistry Systems and the VITROS 5600 Integrated System.","Multiple lots affected, with expiry dates through 22-Mar-2015",,"19,438 units (8,845 units domestically & 10,593 units internationally)","Ortho Clinical Diagnostics is recalling Slide Dispense cartridges used with some VITROS Chemistry Product Slides due to slide dispense issues. ",6/12/2013,"06/12/2013",11/27/2013,"11/27/2013"
"Devices",65572,"Ongoing","Ortho-Clinical Diagnostics","Rochester","NY","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution - USA (nationwide) including AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NY, OH, OK, OR, PA, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV, and WY including Puerto Rico and Internationally to Australia, Brazil, Canada, Chile, China, Colombia, India, Japan, Mexico, Panama, Singapore, Venezuela, England, Germany, France, Italy, and Spain.","Z-0323-2014","Class II","VITROS Chemistry Products SALI Slides packaged as 90 slides/pack catalog number 1314343 VITROS SALI Slides quantitatively measure salicylate (SALI) concentration in serum and plasma using VITROS 250/350/950/5,1 FS and 4600 Chemistry Systems and the VITROS 5600 Integrated System.","Multiple lots affected, with expiry dates through 22-Mar-2015",,"15,492 units (11,870 units domestically & 3,622 units internationally)","Ortho Clinical Diagnostics is recalling Slide Dispense cartridges used with some VITROS Chemistry Product Slides due to slide dispense issues. ",6/12/2013,"06/12/2013",11/27/2013,"11/27/2013"
"Devices",65572,"Ongoing","Ortho-Clinical Diagnostics","Rochester","NY","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution - USA (nationwide) including AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NY, OH, OK, OR, PA, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV, and WY including Puerto Rico and Internationally to Australia, Brazil, Canada, Chile, China, Colombia, India, Japan, Mexico, Panama, Singapore, Venezuela, England, Germany, France, Italy, and Spain.","Z-0307-2014","Class II","VITROS Chemistry Products CRBM Slides packaged as 90 slides/pack catalog number 8892382","Multiple lots affected, with expiry dates through 22-Mar-2015",,"12,484 units (9,040 units domestically & 3,444 units internationally)","Ortho Clinical Diagnostics is recalling Slide Dispense cartridges used with some VITROS Chemistry Product Slides due to slide dispense issues. VITROS CRBM Slides quantitatively measure carbamazepine (CRBM) concentration in serum and plasma using VITROS 250/350/950/5,1 FS and 4600 Chemistry Systems and the VITROS 5600 Integrated System.",6/12/2013,"06/12/2013",11/27/2013,"11/27/2013"
"Devices",65572,"Ongoing","Ortho-Clinical Diagnostics","Rochester","NY","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution - USA (nationwide) including AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NY, OH, OK, OR, PA, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV, and WY including Puerto Rico and Internationally to Australia, Brazil, Canada, Chile, China, Colombia, India, Japan, Mexico, Panama, Singapore, Venezuela, England, Germany, France, Italy, and Spain.","Z-0301-2014","Class II","VITROS Chemistry Products BUN/UREA Slides packaged as 300 slides/pack catalog number 8102204 VITROS BUN/UREA Slides quantitatively measure urea concentration, reported either as urea nitrogen (BUN) or as urea (UREA), in serum, plasma, and urine using VITROS 250/350/950/5,1 FS and 4600 Chemistry Systems and the VITROS 5600 Integrated System.","Multiple lots affected, with expiry dates through 22-Mar-2015",,"31,0947 units (139,602 units domestically & 171,345 units internationally)","Ortho Clinical Diagnostics is recalling Slide Dispense cartridges used with some VITROS Chemistry Product Slides due to slide dispense issues. ",6/12/2013,"06/12/2013",11/27/2013,"11/27/2013"
"Devices",65572,"Ongoing","Ortho-Clinical Diagnostics","Rochester","NY","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution - USA (nationwide) including AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NY, OH, OK, OR, PA, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV, and WY including Puerto Rico and Internationally to Australia, Brazil, Canada, Chile, China, Colombia, India, Japan, Mexico, Panama, Singapore, Venezuela, England, Germany, France, Italy, and Spain.","Z-0324-2014","Class II","VITROS Chemistry Products TBIL Slides packaged as 300 slides/pack catalog number 8159931 VITROS TBIL Slides quantitatively measure total bilirubin (TBIL) concentration in serum and plasma using VITROS 250/350/950/5,1 FS and 4600 Chemistry Systems and the VITROS 5600 Integrated System.","Multiple lots affected, with expiry dates through 22-Mar-2015",,"175,689 units (86,745 units domestically & 88,944 units internationally)","Ortho Clinical Diagnostics is recalling Slide Dispense cartridges used with some VITROS Chemistry Product Slides due to slide dispense issues. ",6/12/2013,"06/12/2013",11/27/2013,"11/27/2013"
"Devices",65572,"Ongoing","Ortho-Clinical Diagnostics","Rochester","NY","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution - USA (nationwide) including AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NY, OH, OK, OR, PA, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV, and WY including Puerto Rico and Internationally to Australia, Brazil, Canada, Chile, China, Colombia, India, Japan, Mexico, Panama, Singapore, Venezuela, England, Germany, France, Italy, and Spain.","Z-0328-2014","Class II","VITROS Chemistry Products URIC Slides packaged as 300 slides/pack catalog number 1943927 VITROS URIC Slides quantitatively measure uric acid (URIC) concentration in serum, plasma, and urine using VITROS 250/350/950/5,1 FS and 4600 Chemistry Systems and the VITROS 5600 Integrated System.","Multiple lots affected, with expiry dates through 22-Mar-2015",,"85,646 units (13,640 units domestically & 72,006 units internationally)","Ortho Clinical Diagnostics is recalling Slide Dispense cartridges used with some VITROS Chemistry Product Slides due to slide dispense issues. ",6/12/2013,"06/12/2013",11/27/2013,"11/27/2013"
"Devices",65572,"Ongoing","Ortho-Clinical Diagnostics","Rochester","NY","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution - USA (nationwide) including AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NY, OH, OK, OR, PA, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV, and WY including Puerto Rico and Internationally to Australia, Brazil, Canada, Chile, China, Colombia, India, Japan, Mexico, Panama, Singapore, Venezuela, England, Germany, France, Italy, and Spain.","Z-0316-2014","Class II","VITROS Chemistry Products Li Slides packaged as 300 slides/pack catalog number 8318925 and packaged as 90 slides/pack catalog number 1632660 VITROS Li Slides quantitatively measure lithium (Li) concentration in serum and plasma using VITROS 250/350/950/5,1 FS and 4600 Chemistry Systems and the VITROS 5600 Integrated System.","Multiple lots affected, with expiry dates through 22-Mar-2015",,"62,039 units (5,974 units domestically & 4,702 units internationally)","Ortho Clinical Diagnostics is recalling Slide Dispense cartridges used with some VITROS Chemistry Product Slides due to slide dispense issues. ",6/12/2013,"06/12/2013",11/27/2013,"11/27/2013"
"Devices",65572,"Ongoing","Ortho-Clinical Diagnostics","Rochester","NY","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution - USA (nationwide) including AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NY, OH, OK, OR, PA, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV, and WY including Puerto Rico and Internationally to Australia, Brazil, Canada, Chile, China, Colombia, India, Japan, Mexico, Panama, Singapore, Venezuela, England, Germany, France, Italy, and Spain.","Z-0292-2014","Class II","VITROS Chemistry Products ACET Slides, 90 slides/pack; catalog number 1037274 VITROS Chemistry Products ACET Slides quantitatively measure acetaminophen (ACET) concentration in serum and plasma using VITROS 250/350/950/5,1 FS and 4600 Chemistry Systems and the VITROS 5600 Integrated System.","Multiple lots affected, with expiry dates through 22-Mar-2015",,"16732 units (12208 units domestically & 4524 internationally)","Ortho Clinical Diagnostics is recalling Slide Dispense cartridges used with some VITROS Chemistry Product Slides due to slide dispense issues. ",6/12/2013,"06/12/2013",11/27/2013,"11/27/2013"
"Devices",65572,"Ongoing","Ortho-Clinical Diagnostics","Rochester","NY","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution - USA (nationwide) including AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NY, OH, OK, OR, PA, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV, and WY including Puerto Rico and Internationally to Australia, Brazil, Canada, Chile, China, Colombia, India, Japan, Mexico, Panama, Singapore, Venezuela, England, Germany, France, Italy, and Spain.","Z-0313-2014","Class II","VITROS Chemistry Products Fe Slides packaged as 300 slides/pack catalog number 1515808 and packaged as 90 slides/pack catalog number 1924547 VITROS Fe Slides quantitatively measure iron (Fe) concentration in serum and plasma using VITROS 250/350/950/5,1 FS and 4600 Chemistry Systems and the VITROS 5600 Integrated System.","Multiple lots affected, with expiry dates through 22-Mar-2015",,"37,525 units (11,898 units domestically & 25,627 units internationally)","Ortho Clinical Diagnostics is recalling Slide Dispense cartridges used with some VITROS Chemistry Product Slides due to slide dispense issues. ",6/12/2013,"06/12/2013",11/27/2013,"11/27/2013"
"Devices",65572,"Ongoing","Ortho-Clinical Diagnostics","Rochester","NY","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution - USA (nationwide) including AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NY, OH, OK, OR, PA, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV, and WY including Puerto Rico and Internationally to Australia, Brazil, Canada, Chile, China, Colombia, India, Japan, Mexico, Panama, Singapore, Venezuela, England, Germany, France, Italy, and Spain.","Z-0295-2014","Class II","VITROS Chemistry Products ALC Slides, 90 slides/pack; catalog number 8046872 VITROS ALC Slides quantitatively measure ethanol (ALC) concentration in serum and plasma using VITROS 250/350/950/5,1 FS and 4600 Chemistry Systems and the VITROS 5600 Integrated System.","Multiple lots affected, with expiry dates through 22-Mar-2015",,"28501 units (20321 domestically & 8180 internationally)","Ortho Clinical Diagnostics is recalling Slide Dispense cartridges used with some VITROS Chemistry Product Slides due to slide dispense issues. ",6/12/2013,"06/12/2013",11/27/2013,"11/27/2013"
"Devices",65572,"Ongoing","Ortho-Clinical Diagnostics","Rochester","NY","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution - USA (nationwide) including AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NY, OH, OK, OR, PA, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV, and WY including Puerto Rico and Internationally to Australia, Brazil, Canada, Chile, China, Colombia, India, Japan, Mexico, Panama, Singapore, Venezuela, England, Germany, France, Italy, and Spain.","Z-0298-2014","Class II","VITROS Chemistry Products AMYL Slides packaged as 300 slides/pack catalog number 1202670 and packaged as 90 slides/pack catalog number 8112724 VITROS AMYL Slides quantitatively measure amylase (AMYL) activity in serum, plasma, and urine using VITROS 250/350/950/5,1 FS and 4600 Chemistry Systems and the VITROS 5600 Integrated System.","Multiple lots affected, with expiry dates through 22-Mar-2015",,"70,125 units (20,219 units domestically & 49,906 units internationally)","Ortho Clinical Diagnostics is recalling Slide Dispense cartridges used with some VITROS Chemistry Product Slides due to slide dispense issues. ",6/12/2013,"06/12/2013",11/27/2013,"11/27/2013"
"Devices",65572,"Ongoing","Ortho-Clinical Diagnostics","Rochester","NY","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution - USA (nationwide) including AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NY, OH, OK, OR, PA, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV, and WY including Puerto Rico and Internationally to Australia, Brazil, Canada, Chile, China, Colombia, India, Japan, Mexico, Panama, Singapore, Venezuela, England, Germany, France, Italy, and Spain.","Z-0321-2014","Class II","VITROS Chemistry Products PHYT Slides packaged as 90 slides/pack catalog number 8298671 VITROS PHYT Slides quantitatively measure phenytoin (PHYT) concentration in serum and plasma using VITROS 250/350/950/5,1 FS and 4600 Chemistry Systems and the VITROS 5600 Integrated System.","Multiple lots affected, with expiry dates through 22-Mar-2015",,"21,163 units (16,218 units domestically & 4,945 units internationally)","Ortho Clinical Diagnostics is recalling Slide Dispense cartridges used with some VITROS Chemistry Product Slides due to slide dispense issues. ",6/12/2013,"06/12/2013",11/27/2013,"11/27/2013"
"Devices",65572,"Ongoing","Ortho-Clinical Diagnostics","Rochester","NY","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution - USA (nationwide) including AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NY, OH, OK, OR, PA, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV, and WY including Puerto Rico and Internationally to Australia, Brazil, Canada, Chile, China, Colombia, India, Japan, Mexico, Panama, Singapore, Venezuela, England, Germany, France, Italy, and Spain.","Z-0297-2014","Class II","VITROS Chemistry Products AMON Slides packaged as 300 slides/pack catalog number 1721869 and packaged as 90 slides/pack catalog number 1726926 VITROS AMON Slides quantitatively measure ammonia concentration in plasma using VITROS 250/350/950/5,1 FS and 4600 Chemistry Systems and the VITROS 5600 Integrated System.","Multiple lots affected, with expiry dates through 22-Mar-2015",,"24322 units (12329 units domestically & 11993 units internationally)","Ortho Clinical Diagnostics is recalling Slide Dispense cartridges used with some VITROS Chemistry Product Slides due to slide dispense issues. ",6/12/2013,"06/12/2013",11/27/2013,"11/27/2013"
"Devices",65572,"Ongoing","Ortho-Clinical Diagnostics","Rochester","NY","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution - USA (nationwide) including AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NY, OH, OK, OR, PA, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV, and WY including Puerto Rico and Internationally to Australia, Brazil, Canada, Chile, China, Colombia, India, Japan, Mexico, Panama, Singapore, Venezuela, England, Germany, France, Italy, and Spain.","Z-0325-2014","Class II","VITROS Chemistry Products THEO Slides packaged as 300 slides/pack catalog number 8301764 and packaged as 90 slides/pack catalog number 1307164 VITROS THEO Slides quantitatively measure theophylline (THEO) concentration in serum and plasma using VITROS 250/350/950/5,1 FS and 4600 Chemistry Systems and the VITROS 5600 Integrated System.","Multiple lots affected, with expiry dates through 22-Mar-2015",,"7,926 units (6,026 units domestically & 1,900 units internationally)","Ortho Clinical Diagnostics is recalling Slide Dispense cartridges used with some VITROS Chemistry Product Slides due to slide dispense issues. ",6/12/2013,"06/12/2013",11/27/2013,"11/27/2013"
"Devices",65572,"Ongoing","Ortho-Clinical Diagnostics","Rochester","NY","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution - USA (nationwide) including AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NY, OH, OK, OR, PA, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV, and WY including Puerto Rico and Internationally to Australia, Brazil, Canada, Chile, China, Colombia, India, Japan, Mexico, Panama, Singapore, Venezuela, England, Germany, France, Italy, and Spain.","Z-0309-2014","Class II","VITROS Chemistry Products CRP Slides packaged as 90 slides/pack catalog number 8097990 VITROS CRP Slides quantitatively measure C-reactive protein (CRP) concentration in serum and plasma using VITROS 250/350/950/5,1 FS and 4600 Chemistry Systems and the VITROS 5600 Integrated System.","Multiple lots affected, with expiry dates through 22-Mar-2015",,"86,522 units (30,717 units domestically & 55,805 units internationally)","Ortho Clinical Diagnostics is recalling Slide Dispense cartridges used with some VITROS Chemistry Product Slides due to slide dispense issues. ",6/12/2013,"06/12/2013",11/27/2013,"11/27/2013"
"Devices",65572,"Ongoing","Ortho-Clinical Diagnostics","Rochester","NY","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution - USA (nationwide) including AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NY, OH, OK, OR, PA, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV, and WY including Puerto Rico and Internationally to Australia, Brazil, Canada, Chile, China, Colombia, India, Japan, Mexico, Panama, Singapore, Venezuela, England, Germany, France, Italy, and Spain.","Z-0308-2014","Class II","VITROS Chemistry Products CREA Slides packaged as 300 slides/pack catalog number 6802584 VITROS CREA Slides quantitatively measure creatinine (CREA) concentration in serum, plasma, and urine using VITROS 250/350/950/5,1 FS and 4600 Chemistry Systems and the VITROS 5600 Integrated System.","Multiple lots affected, with expiry dates through 22-Mar-2015",,"364,752 units (148,285 units domestically & 216,467 units internationally)","Ortho Clinical Diagnostics is recalling Slide Dispense cartridges used with some VITROS Chemistry Product Slides due to slide dispense issues. ",6/12/2013,"06/12/2013",11/27/2013,"11/27/2013"
"Devices",65572,"Ongoing","Ortho-Clinical Diagnostics","Rochester","NY","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution - USA (nationwide) including AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NY, OH, OK, OR, PA, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV, and WY including Puerto Rico and Internationally to Australia, Brazil, Canada, Chile, China, Colombia, India, Japan, Mexico, Panama, Singapore, Venezuela, England, Germany, France, Italy, and Spain.","Z-0306-2014","Class II","VITROS Chemistry Products CK-MB Slides packaged as 300 slides/pack catalog number 8058232 and packaged as 90 slides/pack catalog number 8001133 VITROS CK Slides quantitatively measure creatine kinase (CK) activity in serum and plasma using VITROS 250/350/950/5,1 FS and 4600 Chemistry Systems and the VITROS 5600 Integrated System.","Multiple lots affected, with expiry dates through 22-Mar-2015",,"28,739 units (480 units domestically & 32,739 units internationally)","Ortho Clinical Diagnostics is recalling Slide Dispense cartridges used with some VITROS Chemistry Product Slides due to slide dispense issues. ",6/12/2013,"06/12/2013",11/27/2013,"11/27/2013"
"Devices",65572,"Ongoing","Ortho-Clinical Diagnostics","Rochester","NY","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution - USA (nationwide) including AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NY, OH, OK, OR, PA, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV, and WY including Puerto Rico and Internationally to Australia, Brazil, Canada, Chile, China, Colombia, India, Japan, Mexico, Panama, Singapore, Venezuela, England, Germany, France, Italy, and Spain.","Z-0304-2014","Class II","VITROS Chemistry Products CHOL Slides packaged as 300 slides/pack catalog number 1669829 VITROS CHOL Slides quantitatively measure cholesterol (CHOL) concentration in serum and plasma using VITROS 250/350/950/5,1 FS and 4600 Chemistry Systems and the VITROS 5600 Integrated System.","Multiple lots affected, with expiry dates through 22-Mar-2015",,"28,855 units (12,472 units domestically & 16,383 units internationally)","Ortho Clinical Diagnostics is recalling Slide Dispense cartridges used with some VITROS Chemistry Product Slides due to slide dispense issues. ",6/12/2013,"06/12/2013",11/27/2013,"11/27/2013"
"Devices",65572,"Ongoing","Ortho-Clinical Diagnostics","Rochester","NY","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution - USA (nationwide) including AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NY, OH, OK, OR, PA, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV, and WY including Puerto Rico and Internationally to Australia, Brazil, Canada, Chile, China, Colombia, India, Japan, Mexico, Panama, Singapore, Venezuela, England, Germany, France, Italy, and Spain.","Z-0314-2014","Class II","VITROS Chemistry Products GLU Slides packaged as 300 slides/pack catalog number 1707801 VITROS GLU Slides quantitatively measure glucose (GLU) concentration in serum, plasma, urine and cerebrospinal fluid using VITROS 250/350/950/5,1 FS and 4600 Chemistry Systems and the VITROS 5600 Integrated System.","Multiple lots affected, with expiry dates through 22-Mar-2015",,"349,072 units (142,455 units domestically & 205,617 units internationally)","Ortho Clinical Diagnostics is recalling Slide Dispense cartridges used with some VITROS Chemistry Product Slides due to slide dispense issues. ",6/12/2013,"06/12/2013",11/27/2013,"11/27/2013"
"Devices",65572,"Ongoing","Ortho-Clinical Diagnostics","Rochester","NY","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution - USA (nationwide) including AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NY, OH, OK, OR, PA, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV, and WY including Puerto Rico and Internationally to Australia, Brazil, Canada, Chile, China, Colombia, India, Japan, Mexico, Panama, Singapore, Venezuela, England, Germany, France, Italy, and Spain.","Z-0327-2014","Class II","VITROS Chemistry Products UPRO Slides packaged as 90 slides/pack catalog number 6800120 VITROS UPRO Slides quantitatively measure protein (UPRO) concentration in urine using VITROS 250/350/950/5,1 FS and 4600 Chemistry Systems and the VITROS 5600 Integrated System.","Multiple lots affected, with expiry dates through 22-Mar-2015",,"31,395 units (10,864 units domestically & 20,531 units internationally)","Ortho Clinical Diagnostics is recalling Slide Dispense cartridges used with some VITROS Chemistry Product Slides due to slide dispense issues. ",6/12/2013,"06/12/2013",11/27/2013,"11/27/2013"
"Devices",65573,"Ongoing","Steris Corporation","Mentor","OH","US","Voluntary: Firm Initiated","Visit","USA Nationwide Distribution in the states of CO, KY, LA, VA, and WI. The affected product was also distributed to Canada.","Z-1786-2013","Class II","STERIS Fine Traction Device, one unit per box Product Usage: The Fine Traction Device is used to provide traction and enable fine adjustments to traction and orientation of the leg during orthopedic procedures. ","The following serial/lot numbers are affected by this recall: 0404913150, 0404913151, 0404913152, 0404913153, 0408713001, 0408713002, 0408713003, 0408713004, 0408713005, 0408713006, 0409813097, 0409813098, 0409813099, 0409813100, 0410113001, 0410113002, 0410713024, 0410713025, 0410713026, 0410713027, 0410713028, and 0410713029. ",,"16 units","A bearing used in the assembly of the Fine Traction Device did not perform successfully in pre-release reliability testing; a replacement bushing passed reliability testing and was substituted per a change order. The change order authorized use of the substitute bushing in assembly of the Fine Traction Accessory; however, inadvertently the new part was not implemented. During complaint evaluation of a Fine Traction Device returned by a Customer it was determined that the original part, the bearing, was used in Fine Traction Devices distributed to Customers.",5/20/2013,"05/20/2013",7/31/2013,"07/31/2013"
"Biologics",65574,"Terminated","Interstate Blood Bank, Inc. of Wisconsin","Milwaukee","WI","US","Voluntary: Firm Initiated","FAX","California","B-2302-13","Class III","Source Plasma","12MKED1461; 12MKED0897; 12MKED0578; 12MKEC9948; 12MKEC9702; 12MKEC9401; 12MKEC9084; 12MKEC8710; 12MKEC8381; 12MKED1221; ",,"10","Blood products, collected from an ineligible donor, were distributed. ",4/30/2013,"04/30/2013",9/25/2013,"09/25/2013"
"Food",65575,"Ongoing","R.L. SCHREIBER INC - LEBANON","Lebanon","KY","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","The affected product was distributed to the following states:AZ, CA, CO, FL, ID, IL, MA, MI, MO, NC, NJ, NV, OH, OR, PA, TN, and WA.","F-1644-2013","Class III","R.L. Schreiber Batter Mix, 2.5 lb packaged in white flexible plastic bag, 12 bags per case. ","Product Code CFBATTEB, 1464; Lot Code 3-066-133872 ",".","823 units","Product contains undeclared Red 40. Product does not meet quality specifications for color. ",4/3/2013,"04/03/2013",7/17/2013,"07/17/2013"
"Devices",65576,"Ongoing","Tosoh Smd Inc","Grove City","OH","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution - USA including AK, AL, AR, AZ, CA, CO, CT, DE, FL, GA, IA, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, NE, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, WA, WI, and WY. Internationally to Canada, Japan, Mexico, Chile, and Uruguay.","Z-1830-2013","Class II","AIA Analyzer Pipette Tips used on Tosoh AIA-2000, AIA-1800, AIA-900 and AIA-600II Analyzers, 1000 tips/bag AIA-Analyzer Tips are disposable pipette tips packaged in bulk quantities and used on Tosoh Bioscience AIA Analyzers for lab analysis of various immunoassays.","The following lots numbers are affected by this recall: 060811, 070111, B11, B11-12/23/2011, B12-02/07/2012, B12-04/30/2012, B12-06/01/2012, B12-08/06/2012, B12-09/05/2012, B12-10/26/2012, and B12-11/27/2012. ",,"11,309 bags","Visual inspection of the pipette tips indicated that some of the tips were not uniform in size/length which was causing error messages on the analyzers.",5/15/2013,"05/15/2013",8/7/2013,"08/07/2013"
"Devices",65577,"Ongoing","Baxter Healthcare Corp.","Deerfield","IL","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution - USA (nationwide), Puerto Rico and Internationally to Australia, Austria, Belgium, Brazil, Bulgaria, Canada, Chile, Columbia, Czech Republic, Denmark (including Faroe Islands), Ecuador, Finland, France (including Martinique and Reunion Islands), Germany, Greece, Iceland, India, Ireland, Isreal, Italy, Luxemburg, Japan, Malaysia, Mexico, Netherlands, New Zealand, Norway, Panama, Portugal, Qatar, Russia, Saudi Arabia, Singapore, Slovakia, Slovenia, South Korea, Spain, Sweded, Switzerland, Thailand, Turkey, United Arab Emirates, and United Kingdom.","Z-1678-2013","Class II","Baxter's elastomeric infusion pumps are non-electronic, ambulatory, disposable devices that deliver continuous medication for periods of 30 minutes up to 7 days. They are designed for medication therapies requiring continuous infusion. The infusion pumps can be utilized for slow, continuous delivery through clinically acceptable routes of administration such as intravenous (IV), intra-arterial (IA), and subcutaneous or epidural infusion of medications directly into an intraoperative site or subcutaneously for post-operative pain management.","*** 1) Product Code: 2C1700KP; Lots: 09C013, 09D023; *** 2) Product Code: 2C1702KP; Lots: 08M005, 08M056, 08N055, 09A029, 09B008, 09B061, 09C015, 09D013, 09D043, 09D081, 09E041, 09E070",".","Code 2C1700KP: 7,128 units; Code 2C1702KP: 105,732 units","There are reported incidents of leakage on the INFUSOR and FOLFUSOR pumps at the connection of the blue winged cap and the distal male Luer. Investigation of these reports indicates the incidence of leakage has only occurred after pumps are filled, primed, re-capped (using the blue winged Luer cap) and stored for a period of time, typically overnight. In addition, the reported instances of leakage were contained within the storage pouch provided and observed prior to patient use.",7/31/2009,"07/31/2009",7/17/2013,"07/17/2013"
"Devices",65577,"Ongoing","Baxter Healthcare Corp.","Deerfield","IL","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution - USA (nationwide), Puerto Rico and Internationally to Australia, Austria, Belgium, Brazil, Bulgaria, Canada, Chile, Columbia, Czech Republic, Denmark (including Faroe Islands), Ecuador, Finland, France (including Martinique and Reunion Islands), Germany, Greece, Iceland, India, Ireland, Isreal, Italy, Luxemburg, Japan, Malaysia, Mexico, Netherlands, New Zealand, Norway, Panama, Portugal, Qatar, Russia, Saudi Arabia, Singapore, Slovakia, Slovenia, South Korea, Spain, Sweded, Switzerland, Thailand, Turkey, United Arab Emirates, and United Kingdom.","Z-1677-2013","Class II","Baxter's elastomeric infusion pumps are non-electronic, ambulatory, disposable devices that deliver continuous medication for periods of 30 minutes up to 7 days. They are designed for medication therapies requiring continuous infusion. The infusion pumps can be utilized for slow, continuous delivery through clinically acceptable routes of administration such as intravenous (IV), intra-arterial (IA), and subcutaneous or epidural infusion of medications directly into an intraoperative site or subcutaneously for post-operative pain management.","*** 1) Product Code: 2C1008KP; Lots: 08M036, 08N041, 09A030, 09B044, 09C053, 09D018, 09E019, 09F005; *** 2) Product Code: 2C1009KP; Lots: 08M016, 08M035, 08M066, 09A010, 09A052, 09A065, 09A080, 09B038, 09B048, 09B060, 09B074, 09C03, 09C016, 09C044, 09C060, 09D011, 09D042, 09D049, 09D054, 09E021, 09E043, 09F002; *** 3) Product Code: 2C1063KP; Lots: 08K078, 08M014, 08M060, 08N022, 08N053, 08N074, 09A032, 09A057, 09B006, 09B014, 09C007, 09C017, 09C054, 09C077, 09D015, 09D041, 09E012,09E018, 09E022, 09E044; *** 4) Product Code: 2C1087KP; Lots: 08K074, 08M050, 08N051, 09A053, 09B063, 09C041, 09D044, 09E073; *** 5) Product Code: 2C1156KP; Lots: 08M063, 09C042",".","Code 2C1008KP: 56,400 units; Code 2C1009KP: 180,004 units; Code 2C1063KP: 154,937 units; Code 2C1087KP: 43,521 units; Code 2C1156KP: 7,908 units","There are reported incidents of leakage on the INFUSOR and FOLFUSOR pumps at the connection of the blue winged cap and the distal male Luer. Investigation of these reports indicates the incidence of leakage has only occurred after pumps are filled, primed, re-capped (using the blue winged Luer cap) and stored for a period of time, typically overnight. In addition, the reported instances of leakage were contained within the storage pouch provided and observed prior to patient use.",7/31/2009,"07/31/2009",7/17/2013,"07/17/2013"
"Devices",65577,"Ongoing","Baxter Healthcare Corp.","Deerfield","IL","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution - USA (nationwide), Puerto Rico and Internationally to Australia, Austria, Belgium, Brazil, Bulgaria, Canada, Chile, Columbia, Czech Republic, Denmark (including Faroe Islands), Ecuador, Finland, France (including Martinique and Reunion Islands), Germany, Greece, Iceland, India, Ireland, Isreal, Italy, Luxemburg, Japan, Malaysia, Mexico, Netherlands, New Zealand, Norway, Panama, Portugal, Qatar, Russia, Saudi Arabia, Singapore, Slovakia, Slovenia, South Korea, Spain, Sweded, Switzerland, Thailand, Turkey, United Arab Emirates, and United Kingdom.","Z-1679-2013","Class II","Baxter's elastomeric infusion pumps are non-electronic, ambulatory, disposable devices that deliver continuous medication for periods of 30 minutes up to 7 days. They are designed for medication therapies requiring continuous infusion. The infusion pumps can be utilized for slow, continuous delivery through clinically acceptable routes of administration such as intravenous (IV), intra-arterial (IA), and subcutaneous or epidural infusion of medications directly into an intraoperative site or subcutaneously for post-operative pain management.","*** 1) Product Code: 2C4700K; Lot: 09A014",".","Code 2C4700K: 4,128 units","There are reported incidents of leakage on the INFUSOR and FOLFUSOR pumps at the connection of the blue winged cap and the distal male Luer. Investigation of these reports indicates the incidence of leakage has only occurred after pumps are filled, primed, re-capped (using the blue winged Luer cap) and stored for a period of time, typically overnight. In addition, the reported instances of leakage were contained within the storage pouch provided and observed prior to patient use. *** Note: This product was not sold in the United States.",7/31/2009,"07/31/2009",7/17/2013,"07/17/2013"
"Food",65578,"Ongoing","Fresh Unlimited Inc","Sidney","OH","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","The affected product was distributed to the following states: Indiana, Kentucky, Michigan, New York, Ohio, and Pennsylvania.","F-1713-2013","Class I","Broccoli Salad Kit with Dressing; packaged in plastic bags inside paper cartons, 5 bags per case. ","The affect product has the following SKU #, Description, Pack Size, and Use by Date, respectively: 74807, Broccoli Salad, 4.04lbs per case, 6/17/2013. ",".","2958 bags ","The firm was informed for a supplier that the sunflower raisin mix packets they supplied was a part of the Lipari Foods sunflower seed recalls, which was due to contamination with Listeria monocytogenes. ",6/13/2013,"06/13/2013",7/24/2013,"07/24/2013"
"Food",65578,"Ongoing","Fresh Unlimited Inc","Sidney","OH","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","The affected product was distributed to the following states: Indiana, Kentucky, Michigan, New York, Ohio, and Pennsylvania.","F-1714-2013","Class I","Sweet & Sassy Apple Salad; packaged in plastic bags inside paper cartons, 5 bags per case. ","The affect product has the following SKU #, Description, Pack Size, and Use by Date, respectively: 74891, Sweet & Sassy Apple Salad, 6.125lbs per case, 6/17/2013.",".","189 bags","The firm was informed for a supplier that the sunflower raisin mix packets they supplied was a part of the Lipari Foods sunflower seed recalls, which was due to contamination with Listeria monocytogenes. ",6/13/2013,"06/13/2013",7/24/2013,"07/24/2013"
"Food",65578,"Ongoing","Fresh Unlimited Inc","Sidney","OH","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","The affected product was distributed to the following states: Indiana, Kentucky, Michigan, New York, Ohio, and Pennsylvania.","F-1711-2013","Class I","Broccoli Salad Kit No Dressing, packaged in plastic bags inside paper cartons, 4 bags per case. ","The affect product has the following SKU #, Description, Pack Size, and Use by Date, respectively: 74716, Broccoli Salad Kit No Dressing, 3.625lb per case, 6/17/2013.",".","1207 bags","The firm was informed for a supplier that the sunflower raisin mix packets they supplied was a part of the Lipari Foods sunflower seed recalls, which was due to contamination with Listeria monocytogenes. ",6/13/2013,"06/13/2013",7/24/2013,"07/24/2013"
"Food",65578,"Ongoing","Fresh Unlimited Inc","Sidney","OH","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","The affected product was distributed to the following states: Indiana, Kentucky, Michigan, New York, Ohio, and Pennsylvania.","F-1712-2013","Class I","Broccoli Salad Kit No Dressing, No Bacon; packaged in plastic bags inside paper cartons, 4 bags per case. ","The affect product has the following SKU #, Description, Pack Size, and Use by Date, respectively: 74717, Broccoli Salad Kit No Dressing No Bacon, 3.375lb per case, 6/17/2013.",".","1173 bags","The firm was informed for a supplier that the sunflower raisin mix packets they supplied was a part of the Lipari Foods sunflower seed recalls, which was due to contamination with Listeria monocytogenes. ",6/13/2013,"06/13/2013",7/24/2013,"07/24/2013"
"Devices",65579,"Ongoing","GE Healthcare, LLC","Waukesha","WI","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution - US Nationwide including Guam, Puerto Rico and the countries of : Afghanistan, Algeria, Argentina, Australia, Austria, Belgium, Brazil, Canada, Chile, China, Colombia, Costa Rica, Croatia, Cyprus, Czech Republic, Denmark, Dominican Republic, Ecuador, Egypt, Finland, France, Georgia, Germany, Greece, Hong Kong, Hungary, India, Indonesia, Iran, Ireland, Israel, Italy, Japan, Jordan, Korea (Republic of), Kuwait, Latvia, Lebanon, Lithuania, Malaysia, Malta, Martinique, Mexico, Morocco, Namibia, Netherlands, New Zealand, Norway, Pakistan, Panama, Peru, Philippines, Poland, Portugal, Puerto Rico, Romania, Russia, Saudi Arabia, Singapore, Slovakia, South Africa, Spain, Sweden, Switzerland, Taiwan, Thailand, Tunisia, Turkey, Ukraine, United Kingdom, Uruguay, Venezuela, Vietnam.","Z-1793-2013","Class I","Optima NM/CT 640 Product Usage: The GE Optima NM/CT 640 system is intended for General Nuclear Medicine imaging procedures for detection of radioisotope tracer uptake in the patient body. It includes a general purpose Nuclear Medicine (NM) system using a variety of scanning modes supported by various acquisition types, and a CT component which is intended specifically for enabling attenuation correction and anatomical localization on SPECT studies","System ID: 0910263253, 0910263256, 00139NUC08, 00162NUC11, 030232NU15, 215728OPT640, 262574O640, 270956NM640, 410543NUC640, 715735OPT1, 717782640NM, 808485NM640, 815564O640, 816234D640, 817250NM640, 847872O640, 901516GO640, 915839NU01, 928214NMCT, A5366308, A5639613, BD003NU01, DK1054NM03, RTD0782, XM203401.",,"25","GE became aware of an incident at a VA Medical Center facility in the US in which a patient died due to injuries sustained while being scanned on an Infinia Hawkeye 4 Nuclear Medicine System. UPDATE: On July 03, 2013 GE notified hospitals that they are recalling several Nuclear Medicine Imaging Systems because serious injuries or deaths could occur due to the failure mode associated with this recall. GE advised hospitals that they cease use of their Nuclear Medicine systems until GE can complete an inspection of the system. In this second notification GE included all Nuclear Medicine Systems.",6/13/2013,"06/13/2013",7/31/2013,"07/31/2013"
"Devices",65579,"Ongoing","GE Healthcare, LLC","Waukesha","WI","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution - US Nationwide including Guam, Puerto Rico and the countries of : Afghanistan, Algeria, Argentina, Australia, Austria, Belgium, Brazil, Canada, Chile, China, Colombia, Costa Rica, Croatia, Cyprus, Czech Republic, Denmark, Dominican Republic, Ecuador, Egypt, Finland, France, Georgia, Germany, Greece, Hong Kong, Hungary, India, Indonesia, Iran, Ireland, Israel, Italy, Japan, Jordan, Korea (Republic of), Kuwait, Latvia, Lebanon, Lithuania, Malaysia, Malta, Martinique, Mexico, Morocco, Namibia, Netherlands, New Zealand, Norway, Pakistan, Panama, Peru, Philippines, Poland, Portugal, Puerto Rico, Romania, Russia, Saudi Arabia, Singapore, Slovakia, South Africa, Spain, Sweden, Switzerland, Taiwan, Thailand, Tunisia, Turkey, Ukraine, United Kingdom, Uruguay, Venezuela, Vietnam.","Z-1792-2013","Class I","Discovery NM/CT 670 dual detector free-geometry integrated nuclear imaging system. Product Usage: The GE Discovery NM/CT 670 system is a medical tool intended for use by appropriately trained healthcare professionals to aid in detecting, localizing, diagnosing of diseases and organ function for the evaluation of diseases, trauma, abnormalities, and disorders such as, but not limited to, cardiovascular disease, neurological disorders and cancer. The system output can also be used by the physician for staging and restaging of tumors, planning, guiding, and monitoring therapy. ","System ID: 0828260021, 0828260022, 0850260118, 0850260122, 0850260128, 0850260131, 0850260132, 0853260094, 0853260099, 0856260033, 0856260034, 0856260035, 0910262297, 0910262304, 0910262310, 0910262319, 0910262322, 0910262325, 0910262344, 0910263223, 0910263228, 0910263231, 0910263235, 0910263239, 0910263241, 0910263243, 0910263250, 0910264135, 0910264141, 0910264147, 0910265074, 0910265075, 0910265076, 0920269097, 082426040043, 082426040044, 082426060005, 082426070028, 082426070030, 082426080020, 082426090029, 082426090030, 082426130029, 082426130030, 082426150026, 082426160042, 082426210020, 082426230020, 083026009408410, 083026023683711, 083026201006810, 00001NUC12, 00028NUC01, 00042NUC02, 00046NUC06, 00065NUC08, 00123NUC01, 00149NUC01, 00149NUC03, 00197NUC14, 00199NUC13, 00200NUC07, 00200NUC08, 00234NUC09, 00361NUC08, 00432NUC02, 010120NU19, 030037NU08, 030082NU13, 030133NU13, 030360NU01, 05462NUC05, 06007NUC19, 080041NU04, 100032NU05, 10497NUC20, 110017NU06, 110022NU05, 11018NUC08, 190052NU09, 190163NU04, 190163NU06, 204726D670NM, 210060NU02, 212639NMD670, 250370D670, 260010NU06, 262574D670, 305674D670, 309671SPECT, 403343D670, 403943D670, 403943D670B, 404686NMCT, 410955D670, 410D6701, 415353D670, 416495D670, 418549D670A, 418549D670B, 423495D670, 514281D670, 514338D670, 514842AD670, 514848D670, 514876D670, 519973D670, 529150NU05, 540332D670, 600092NM11, 610402D670NM1, 613548D670, 614NCH670, 615322NM5, 615893MMCT1, 617638DSV670, 630432D670, 720848D670, 803751D670, 819563D670, 819563D670B, 856247D670, 856247NM, 900010NU09, 905472D670, 905684D670A, 905684D670B, 905883D670, 972747NM670, 972935D670, A4169312, A4194844, A51051127, A51142126, A5125139, A5129983, A5196344, B4182011, B5140618, BG4009NM01, D007NU12, DK1029NU14, DK1047NM01, EE1020NM03, FE416061, FI1052MN01, GP1000NM01, HOR0281, IL1020NM36, IL1041NM30, IL1062NM29, M001NU42, M2002713, M251400603, M4134637, M4143630, M4143993, M4144126, M4145158, M4194042, M4198090, M4210246, M4215577, M4476424, M4505290, M5172553, M5400562, M5480777, M9409545, M988684",,"213","GE became aware of an incident at a VA Medical Center facility in the US in which a patient died due to injuries sustained while being scanned on an Infinia Hawkeye 4 Nuclear Medicine System. UPDATE: On July 03, 2013 GE notified hospitals that they are recalling several Nuclear Medicine Imaging Systems because serious injuries or deaths could occur due to the failure mode associated with this recall. GE advised hospitals that they cease use of their Nuclear Medicine systems until GE can complete an inspection of the system. In this second notification GE included all Nuclear Medicine Systems.",6/13/2013,"06/13/2013",7/31/2013,"07/31/2013"
"Devices",65579,"Ongoing","GE Healthcare, LLC","Waukesha","WI","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution - US Nationwide including Guam, Puerto Rico and the countries of : Afghanistan, Algeria, Argentina, Australia, Austria, Belgium, Brazil, Canada, Chile, China, Colombia, Costa Rica, Croatia, Cyprus, Czech Republic, Denmark, Dominican Republic, Ecuador, Egypt, Finland, France, Georgia, Germany, Greece, Hong Kong, Hungary, India, Indonesia, Iran, Ireland, Israel, Italy, Japan, Jordan, Korea (Republic of), Kuwait, Latvia, Lebanon, Lithuania, Malaysia, Malta, Martinique, Mexico, Morocco, Namibia, Netherlands, New Zealand, Norway, Pakistan, Panama, Peru, Philippines, Poland, Portugal, Puerto Rico, Romania, Russia, Saudi Arabia, Singapore, Slovakia, South Africa, Spain, Sweden, Switzerland, Taiwan, Thailand, Tunisia, Turkey, Ukraine, United Kingdom, Uruguay, Venezuela, Vietnam.","Z-1788-2013","Class I","GE Healthcare Varicam/VG and VG Hawkeye devices Product Usage: The intended use of the Quasar system is to perform general Nuclear Medicine imaging procedures for detection of radioisotope tracer uptake in the patient body, using a variety of scanning modes supported by various acquisition typed and optional imaging features designed to enhance image quality in Oncology, Cardiology, Neurology and other clinical diagnostic imaging applications. The scanning modes include planar (Static, Multi-gated, Dynamic, Whole body scanning) and tomographic (SPECT, Gated SPECT, Whole body SPECT, Camera based PET). Acquisition types include single and multi-isotope/multi-peak frame/list mode single-photon and positron imaging. Optional imaging-enhancement features include assortment of collimators, gating by physiological signals, real-time automatic body contouring, and CT-based attenuation correction and functional anatomic mapping. ","System ID: 2998, 6970, 12865, 21414, 38070, 53263, 55461, 56948, 58230, 58378, 58379, 58483, 58510, 58582, 58622, 58630, 58711, 58785, 58797, 58808, 58810, 58871, 58883, 58919, 58958, 58993, 59012, 61061, 63422, 66515, 75074, 79722, 79966, 84636, 92635, 99691, 0850260033, 0850260034, 0850260035, 0850260038, 0850260040, 0850260041, 0850260042, 0850260046, 0850260048, 0850260054, 0850260057, 0850260062, 0853940029, 0853940068, 0853940069, 0853940077, 0853940078, 0853940080, 0853940082, 0856260014, 0856260019, 0910265011, 0910453006, 082426010009, 082426010010, 082426010011, 082426020002, 082426030009, 082426030010, 082426030015, 082426030016, 082426030018, 082426040016, 082426040020, 082426040021, 082426040024, 082426040025, 082426040026, 082426040029, 082426050001, 082426050002, 082426050003, 082426070014, 082426070015, 082426070016, 082426080006, 082426080007, 082426080009, 082426090013, 082426100017, 082426100019, 082426100020, 082426100023, 082426110002, 082426120003, 082426120004, 082426130012, 082426130013, 082426130014, 082426130015, 082426130016, 082426130019, 082426140005, 082426140007, 082426140008, 082426140009, 082426140011, 082426140012, 082426150003, 082426150006, 082426160012, 082426160014, 082426160016, 082426160017, 082426160019, 082426160020, 082426160022, 082426160023, 082426180003, 082426190008, 082426190010, 082426200002, 082426210002, 082426210003, 082426210010, 082426220006, 082426230008, 082426230010, 082426250002, 082426280001, 082426290004, 082426310005, 082426310007, 082426310008, 08302603017002, 08302603135243, 08302606123002, 08302621006334, 083026031062021, 083026242100654, 083026590040004, 083026590040010, 083026598000594, 083026826753913, 0382E00013, 00023NUC06, 0009D, 00132NUC02, 00216NUC09, 00243NUC11, 00243NUC15, 00243NUC17, 00269NUC07, 00323NUC02, 00357NUC02, 00555NUC01, 00584NUC01, 00584NUC04, 0112B, 0277A, 030010NU02, 030028NU01, 030036NU06, 030082NU10, 030151NU05, 030220NU02, 030355NU02, 030388NU01, 0306A, 0343A, 0360A, 06007NUC16, 080041NU01, 082426040029P, 082426050001P, ",,"571","GE became aware of an incident at a VA Medical Center facility in the US in which a patient died due to injuries sustained while being scanned on an Infinia Hawkeye 4 Nuclear Medicine System.",6/13/2013,"06/13/2013",7/31/2013,"07/31/2013"
"Devices",65579,"Ongoing","GE Healthcare, LLC","Waukesha","WI","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution - US Nationwide including Guam, Puerto Rico and the countries of : Afghanistan, Algeria, Argentina, Australia, Austria, Belgium, Brazil, Canada, Chile, China, Colombia, Costa Rica, Croatia, Cyprus, Czech Republic, Denmark, Dominican Republic, Ecuador, Egypt, Finland, France, Georgia, Germany, Greece, Hong Kong, Hungary, India, Indonesia, Iran, Ireland, Israel, Italy, Japan, Jordan, Korea (Republic of), Kuwait, Latvia, Lebanon, Lithuania, Malaysia, Malta, Martinique, Mexico, Morocco, Namibia, Netherlands, New Zealand, Norway, Pakistan, Panama, Peru, Philippines, Poland, Portugal, Puerto Rico, Romania, Russia, Saudi Arabia, Singapore, Slovakia, South Africa, Spain, Sweden, Switzerland, Taiwan, Thailand, Tunisia, Turkey, Ukraine, United Kingdom, Uruguay, Venezuela, Vietnam.","Z-1787-2013","Class I","GE Healthcare Infinia Hawkeye 4 Option For Dual-Head Variable Angle Gamma Camera, Hawkeye Option for Dual-Head Variable Angle Gamma Camera (this includes GE Quasar Nuclear Medicine Systems). Nuclear Medicine Systems Infinia devices Product Usage: The intended use of the Quasar system is to perform general Nuclear Medicine imaging procedures for detection of radioisotope tracer uptake in the patient body, using a variety of scanning modes supported by various acquisition types and optional imaging features designed to enhance image quality in Oncology, Cardiology, Neurology and other clinical diagnostic imaging applications. ","System ID: 1153389, 1299296, 2555007, 2621801, 2638808, 2694593, 2760723, 2768147, 2769200, 2775945, 2812777, 2827087, 2883051, 0828260003, 0828260005, 0828260006, 0828260007, 0828260009, 0828260011, 0828260013, 0828260015, 0828260017, 0828260018, 0828260019, 0828260020, 0834260003, 0834260008, 0834260012, 835260007, 0835260010, 0835260013, 0843260029, 0843260032, 0843260034, 0843260037, 0843260044, 0843260047, 0843260048, 0847260025, 0850260060, 0850260061, 0850260063, 0850260064, 0850260065, 0850260066, 0850260067, 0850260068, 0850260069, 0850260070, 0850260073, 0850260074, 0850260075, 0850260076, 0850260077, 0850260079, 0850260080, 0850260081, 0850260082, 0850260083, 0850260084, 0850260087, 0850260088, 0850260089, 0850260090, 0850260091, 0850260092, 0850260093, 0850260094, 0850260095, 0850260096, 0850260098, 0850260099, 0850260100, 0850260103, 0850260104, 0850260105, 0850260106, 0850260107, 0850260108, 0850260109, 0850260110, 0850260111, 0850260112, 0850260113, 0850260114, 0850260115, 0850260117, 0850260119, 0850260120, 0850260121, 0850260123, 0850260124, 0850260127, 0850260129, 0850260130, 0850260133, 0853260020, 0853260023, 0853260024, 0853260025, 0853260029, 0853260030, 0853260032, 0853260035, 0853260036, 0853260039, 0853260040, 0853260042, 0853260045, 0853260046, 0853260056, 0853260062, 0853260066, 0853260069, 0853260072, 0853260074, 0853260087, 0853260100, 0853260103, 0853260105, 0853260113, 853260118, 0853260119, 0856260023, 0856260024, 0856260025, 0856260026, 0856260028, 856260029, 0856260030, 0856260031, 0856260032, 859260010, 0910262170, 0910262196, 0910262205, 0910262210, 0910262214, 0910262217, 0910262220, 0910262225, 0910262227, 0910262229, 0910262234, 0910262236, 0910262239, 0910262241, 0910262244, 0910262249, 0910262255, 0910262257, 0910262263, 0910262266, 0910262269, 0910262276, 0910262279, 0910262280, 0910262285, 0910262288, 0910262291, 0910262293, 0910262295, 0910262301, 0910262307, 0910262312, 0910262332, 0910262335, 0910262338, 910262349, 0910263135, 0910263143, 0910263157, 0910263159, 09",,"2474","GE became aware of an incident at a VA Medical Center facility in the US in which a patient died due to injuries sustained while being scanned on an Infinia Hawkeye 4 Nuclear Medicine System.",6/13/2013,"06/13/2013",7/31/2013,"07/31/2013"
"Devices",65579,"Ongoing","GE Healthcare, LLC","Waukesha","WI","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution - US Nationwide including Guam, Puerto Rico and the countries of : Afghanistan, Algeria, Argentina, Australia, Austria, Belgium, Brazil, Canada, Chile, China, Colombia, Costa Rica, Croatia, Cyprus, Czech Republic, Denmark, Dominican Republic, Ecuador, Egypt, Finland, France, Georgia, Germany, Greece, Hong Kong, Hungary, India, Indonesia, Iran, Ireland, Israel, Italy, Japan, Jordan, Korea (Republic of), Kuwait, Latvia, Lebanon, Lithuania, Malaysia, Malta, Martinique, Mexico, Morocco, Namibia, Netherlands, New Zealand, Norway, Pakistan, Panama, Peru, Philippines, Poland, Portugal, Puerto Rico, Romania, Russia, Saudi Arabia, Singapore, Slovakia, South Africa, Spain, Sweden, Switzerland, Taiwan, Thailand, Tunisia, Turkey, Ukraine, United Kingdom, Uruguay, Venezuela, Vietnam.","Z-1790-2013","Class I","Brivo NM615, is an all-purpose, single detector integrated nuclear imaging system. Product Usage: The Brivo NM 615 is an emission computed tomography system intended to detect the location and distribution of gamma ray photon emitting radionuclides in the body and to produce cross-sectional images through computer reconstruction of the data. The Brivo NM 615 system is intended for General Nuclear Medicine imaging procedures using variety of scanning modes supported by various acquisition types. This generic type of device may include signal analysis and display equipment, patient and equipment supports, and accessories.","System ID: 030151NU17, 387171NU01, 405456NM615, 406222LN615, 478272NM, 702304NM615, A5635609, HC0541NU03, HC3366NU02, NM24011, NM24015, ZA1819NM04, ZA2446NM01.",,"13","GE became aware of an incident at a VA Medical Center facility in the US in which a patient died due to injuries sustained while being scanned on an Infinia Hawkeye 4 Nuclear Medicine System. UPDATE: On July 03, 2013 GE notified hospitals that they are recalling several Nuclear Medicine Imaging Systems because serious injuries or deaths could occur due to the failure mode associated with this recall. GE advised hospitals that they cease use of their Nuclear Medicine systems until GE can complete an inspection of the system. In this second notification GE included all Nuclear Medicine Systems.",6/13/2013,"06/13/2013",7/31/2013,"07/31/2013"
"Devices",65579,"Ongoing","GE Healthcare, LLC","Waukesha","WI","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution - US Nationwide including Guam, Puerto Rico and the countries of : Afghanistan, Algeria, Argentina, Australia, Austria, Belgium, Brazil, Canada, Chile, China, Colombia, Costa Rica, Croatia, Cyprus, Czech Republic, Denmark, Dominican Republic, Ecuador, Egypt, Finland, France, Georgia, Germany, Greece, Hong Kong, Hungary, India, Indonesia, Iran, Ireland, Israel, Italy, Japan, Jordan, Korea (Republic of), Kuwait, Latvia, Lebanon, Lithuania, Malaysia, Malta, Martinique, Mexico, Morocco, Namibia, Netherlands, New Zealand, Norway, Pakistan, Panama, Peru, Philippines, Poland, Portugal, Puerto Rico, Romania, Russia, Saudi Arabia, Singapore, Slovakia, South Africa, Spain, Sweden, Switzerland, Taiwan, Thailand, Tunisia, Turkey, Ukraine, United Kingdom, Uruguay, Venezuela, Vietnam.","Z-1791-2013","Class I","Discovery NM 630, dual detector free-geometry integrated nuclear imaging system. Product Usage: The GE Discovery NM 630 system is a medical tool intended for use by appropriately trained healthcare professionals to aid in detecting, localizing, diagnosing of diseases and in assessment of organ function for the evaluation of diseases, trauma, abnormalities, and disorders such as, but not limited to, cardiovascular disease, neurological disorders and cancer. The system output can also be used by the physician for staging and restaging of tumors, planning, guiding, and monitoring therapy. The GE Discovery NM 630 system is a Nuclear Medicine (NM) system, which is intended to yield General Nuclear Medicine imaging procedures for detection of radioisotope tracer uptake in the patient body, using a variety of scanning modes supported by various acquisition types and imaging features designed to enhance image quality. The scanning modes include planar mode (Static, Multi-gated, Dynamic and Whole body scanning) and tomographic mode (SPECT, Gated SPECT, Whole body SPECT). The acquisition types include single and multi-isotope/ multi peak frame/list mode single-photon imaging. The imaging-enhancement features include assortment of collimators, gating by physiological signals, and real-time automatic body contouring. The GE Discovery NM 630 system may include signal analysis and display equipment, patient and equipment supports, components and accessories. The system may be used for patients of all ages.","System ID: 0850260134, 083026001113611, 00001NUC11, 00052NUC11, 030029NU05, 030151NU15, 030359NU07, 201418D630, 205333D630, 207664NM630, 208455NM630, 217544PH630, 251639D630, 262574D630, 269945D630, 270417D630, 281540D630, 301877D630, 305596D630A, 305596D630B, 317887D630, 318448D630, 318798D630, 319364D630A, 319364D630B, 330386D630, 334287NM630, 34363NUC01, 407431NU01, 409212NM630, 417533D630, 417781D630, 469814NM630, 580531NM630, 585922NM630, 601288D630, 601354D630, 601798D630, 609978D630, 614NCH630, 618443DISC1, 618842DISC1, 618942NM630, 619474D630, 651DSC630, 702388VNM2, 704355D630, 708684D630, 716372NM630, 719587D630, 770751D630, 773282D630, 801714D630, 804675D630A, 808485NM630, 813558D630, 813615D630, 814623D630, 815564D630, 816234D630, 843347D630, 843797TD630, 845454D630, 870939NU01, 870939NU02, 901226D630, 903GSD630, 904276DSC1, 904321DSC1, 905684D630, 913345D630, 918502DIS1, 936NMD630, 937SNHC630, 941LWRNM630, 956523D630, 978354DSV630, 989227D630, A5131865, A5366307, A5384208, A5812287, EG1040NM01, H002NU03, H3001NUC01, HC0863NU02, IE1018MN03, IE1044NM01, JHDSV630NM, M4216453, M4476428, M45052111, NM22073, NO1035MN06, NT3001, NT3002, NT3003, NT3010, NT3020, O009NU09, OSC630, PC3003NU01, PMAB01NU04, POIN630, PRINCE630, RTD0739, RU1136NM01, TP0004NU01.",,"108","GE became aware of an incident at a VA Medical Center facility in the US in which a patient died due to injuries sustained while being scanned on an Infinia Hawkeye 4 Nuclear Medicine System. UPDATE: On July 03, 2013 GE notified hospitals that they are recalling several Nuclear Medicine Imaging Systems because serious injuries or deaths could occur due to the failure mode associated with this recall. GE advised hospitals that they cease use of their Nuclear Medicine systems until GE can complete an inspection of the system. In this second notification GE included all Nuclear Medicine Systems.",6/13/2013,"06/13/2013",7/31/2013,"07/31/2013"
"Devices",65579,"Ongoing","GE Healthcare, LLC","Waukesha","WI","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution - US Nationwide including Guam, Puerto Rico and the countries of : Afghanistan, Algeria, Argentina, Australia, Austria, Belgium, Brazil, Canada, Chile, China, Colombia, Costa Rica, Croatia, Cyprus, Czech Republic, Denmark, Dominican Republic, Ecuador, Egypt, Finland, France, Georgia, Germany, Greece, Hong Kong, Hungary, India, Indonesia, Iran, Ireland, Israel, Italy, Japan, Jordan, Korea (Republic of), Kuwait, Latvia, Lebanon, Lithuania, Malaysia, Malta, Martinique, Mexico, Morocco, Namibia, Netherlands, New Zealand, Norway, Pakistan, Panama, Peru, Philippines, Poland, Portugal, Puerto Rico, Romania, Russia, Saudi Arabia, Singapore, Slovakia, South Africa, Spain, Sweden, Switzerland, Taiwan, Thailand, Tunisia, Turkey, Ukraine, United Kingdom, Uruguay, Venezuela, Vietnam.","Z-1789-2013","Class I","Elscint APEX Helix, dual-head, multi-purpose, Slip-Ring, digital gamma camera Product Usage: The intended use of the Quasar system is to perform general Nuclear Medicine imaging procedures for detection of radioisotope tracer uptake in the patient body, using a variety of scanning modes supported by various acquisition typed and optional imaging features designed to enhance image quality in Oncology, Cardiology, Neurology and other clinical diagnostic imaging applications. The scanning modes include planar (Static, Multi-gated, Dynamic, Whole body scanning) and tomographic (SPECT, Gated SPECT, Whole body SPECT, Camera based PET). Acquisition types include single and multi-isotope/multi-peak frame/list mode single-photon and positron imaging. Optional imaging-enhancement features include assortment of collimators, gating by physiological signals, real-time automatic body contouring, and CT-based attenuation correction and functional anatomic mapping. ","System ID: 57503, 57584, 57588, 57711, 57727, 57734, 57815, 57873, 58826, 0828960002, 082426010006, 082426130005, 082426160008, 00243NUC09, 0090J, 0177A, 0201B, 0252A, 0272B, 0274B, 0279A, 0280A, 0286A, 030038NU04, 030151NU02, 030232NU04, 080019NU03, 210001NU01, 250565NUC2, 416586HELIX, 418589HELIX, 506739HELIX, 519464HELIX, 61420HELIX, A5110123, A5153605, AP2302NM01, B4213128, B5315316, CS1013NM01, FE8161EL18, IL1041NM01, IL1042NM02, IL1062NM02, M4148612, M4392002, MPX247EL09, NE4191EL15, PL1139NM01, SK1042NM01.",,"50","GE became aware of an incident at a VA Medical Center facility in the US in which a patient died due to injuries sustained while being scanned on an Infinia Hawkeye 4 Nuclear Medicine System.",6/13/2013,"06/13/2013",7/31/2013,"07/31/2013"
"Food",65581,"Ongoing","Sani Fresh Distribution","Long Island City","NY","US","Voluntary: Firm Initiated","Visit","Borough of Queens, NY","F-1724-2013","Class I","Sani Fresh Distribution brand MINI KAISER 10, Net Weight 13 OZ, Product of Canada, UPC 0 56931 51125 2 --- DISTRIBUTED BY SANI BAKERY INC. 28-24 STEINWAY ST., SUITE 108, ASTORIA NY 11103 --- The mini kaisers are packed in clear plastic sealed bags (contain 10 rolls per bag) which are placed in unmarked brown boxes/cartons. The product has a short shelf life.","UPC 0 56931 51125 2 and no other coding",".","93 cartons","Canadian firm recalled Mini Kaiser 10 due to undeclared soy in the product. The product was also found to contain undeclared wheat, sulfites, soybean oil and gluten (barley and/or rye) all from the Doughmaster 200 raw material.",6/22/2013,"06/22/2013",7/24/2013,"07/24/2013"
"Drugs",65582,"Ongoing","West-Ward Pharmaceutical Corp.","Eatontown","NJ","US","Voluntary: Firm Initiated","Letter","GA","D-839-2013","Class II","VersaPharm Incorporated, Ethambutol Hydrochloride Tablets, USP 400 mg 60 tablets, Rx Only, Mfd. for VersaPharm Incorporated Marietta, GA 30065-1509; Mfd. by: West-ward Pharmaceuticals Corp., Eatontown, NJ 07724 NDC 61748-014-06,","Lot 69968B 03/14",".","118 bottles","Discoloration: Ethambutol HCl Tablets 400 mg is being recalled due to a Out of Specification result for description testing for a surface defect of ink.",6/4/2013,"06/04/2013",8/14/2013,"08/14/2013"
"Devices",65583,"Ongoing","GE Healthcare, LLC","Waukesha","WI","US","Voluntary: Firm Initiated","Visit","Worldwide distribution: US (nationwide) including states of: AL, AZ, CA, CO, CT, DC, FL, GA, IL, IN, IA, LA, MA, MI, MS, MO, MT, NE, NV, NJ, NY, NC, OH, OK, PA,RI, SC, TN, TX, VA, WA, and WI; and countries of: ALGERIA, AUSTRALIA, AUSTRIA, BRAZIL, CANADA, COLOMBIA, CZECH REPUBLIC, DENMARK, ESTONIA, FINLAND, FRANCE, GERMANY, GREECE, INDIA, INDONESIA, IRELAND, ITALY, JAPAN, LATVIA, LEBANON, MALAYSIA, MOROCCO, NETHERLANDS, NEW ZEALAND, NORWAY, POLAND, PORTUGAL, REPUBLIC OF MOLDOVIA, ROMANIA, RUSSIAN FEDERATION, SAUDI ARABIA, SINGAPORE, SLOVENIA, SOUTH AFRICA, SOUTH KOREA, SPAIN, SWEDEN, SWITZERLAND, THAILAND, TUNISIA, TURKEY, UNITED ARAB EMIRATES, UNITED KINGDOM, and YUGOSLAVIA.","Z-1944-2013","Class II","GE Healthcare, LOGIQ S8 Ultrasound System The device is intended for use by a qualified physician for ultrasound evaluation of Fetal; Abdominal; Pediatric; Small Organ (breast, testes, thyroid); Neonatal Cephalic; Adult Cephalic; Cardiac (adult and pediatric); Peripheral Vascular; Musculo-skeletal Conventional and Superficial; Urology (including prostate); Transrectal; Transvaginal and Intraoperative (abdominal, thoracic, vascular and neurosurgical).","Mfg Lot or Serial # 171947SU5 176566SU8 176567SU6 179458SU5 182385SU5 182653SU6 182654SU4 182656SU9 164236SU2 173818SU6 172242SU0 172243SU8 176260SU8 180632SU2 181231SU2 181232SU0 181233SU8 181234SU6 181235SU3 158763SU3 158799SU7 159780SU6 163222SU3 165600SU8 168075SU0 169495SU9 170681SU1 170893SU2 171937SU6 171941SU8 171943SU4 176123SU8 176125SU3 176129SU5 177080SU9 178951SU0 180108SU3 180110SU9 180763SU5 180766SU8 182661SU9 182379SU8 176132SU9 159604SU8 159766SU5 158247SU7 172656SU1 161686SU1 170273SU7 170272SU9 170274SU5 176924SU9 159768SU1 170197SU8 171541SU6 171540SU8 171542SU4 164268SU5 166218SU8 171371SU8 168779SU7 167274SU0 171369SU2 177085SU8 177084SU1 171370SU0 168788SU8 178593SU0 178594SU8 178595SU5 176926SU4 176925SU6 158248SU5 159963SU8 160741SU5 160742SU3 160743SU1 159964SU6 178592SU2 159965SU3 159767SU3 181434SU2 166181SU8 183107SU2 169509SU7 159792SU1 183118SU9 170672SU0 176130SU3 182380SU6 158768SU2 159776SU4 182223SU8 182222SU0 183104SU9 166172SU7 170671SU2 168080SU0 182655SU1 183102SU3 183907SU5 176939SU7 180973SU0 176938SU9 183660SU0 183661SU8 180363SU4 159246SU8 158802SU9 158805SU2 180762SU7 170669SU6 170679SU5 170683SU7 162595SU3 162592SU0 170670SU4 183108SU0 168064SU4 169487SU6 169506SU3 176121SU2 158806SU0 178022SU0 159784SU8 165587SU7 168058SU6 170676SU1 163224SU9 159789SU7 182227SU9 178023SU8 165585SU1 168056SU0 182228SU7 182376SU4 168063SU6 183105SU6 168068SU5 170675SU3 168069SU3 165588SU5 175622SU0 175623SU8 168070SU1 180761SU9 182382SU2 176136SU0 159782SU2 159783SU0 168057SU8 182230SU3 183106SU4 182378SU0 168060SU2 163225SU6 183109SU8 183110SU6 168059SU4 166185SU9 159788SU9 178018SU8 170674SU6 161687SU9 161688SU7 161689SU5 161690SU3 161691SU1 161692SU9 162593SU8 162594SU6 165584SU4 176135SU2 165583SU6 165586SU9 182377SU2 158800SU3 159793SU9 159951SU3 168074SU3 170892SU4 171944SU2 162596SU1 168071SU9 175624SU6 178027SU9 181605SU7 166178SU4 183120SU5 178026SU1 171946SU7 182224SU6 170897SU3 168073SU5 178016SU2 169502SU2 169508SU9 178029SU5 180768SU4 161694SU5 176138SU6 159249SU2 18311",,"755","GE Healthcare became aware of a potential issue related to incorrect image measurement associated with the software of the LOGIQ S8 system. This issue was found internally. Users may notice that the system shows incorrect image measurement results on Pulsed Wave (PW) or Time Intensity Curve (TIC) or depth measurement when using Virtual Convex mode and putting a cursor (Sample Volume, Depth measurement) near the edge of the image. As a result the cursor may need to be moved from near the edge of the image area.",8/13/2012,"08/13/2012",8/21/2013,"08/21/2013"
"Devices",65584,"Terminated","Riverpoint Medical, LLC","Portland","OR","US","Voluntary: Firm Initiated","Letter","US Distribution in the states of: AZ, FL, and TX.","Z-0347-2014","Class II","Polyglycolic-Lactic Acid Absorbable Surgical Suture Label reads in part ''Coated VILET *** (Polyglacin 910) Suture UNDYED BRANDED V423 *** Riverpoint ***'' PGLA surgical suture is indicated for use in general soft tissue approximation and/or ligation, including use in opthalmic procedures, but not for use in cardiovascular and neurological tissues","Lot 120716-01",,"1932 pieces","Riverpoint Medical is recalling PGLA Surgical Suture (Vilet) because the label indicates the suture is undyed and it is actually a violet colored suture. ",12/13/2012,"12/13/2012",11/27/2013,"11/27/2013"
"Devices",65586,"Ongoing","Carestream Health Inc.","Rochester","NY","US","Voluntary: Firm Initiated","Letter","Worldwide distribution: US (nationwide) including states of: AL, AR, AZ, CA, CO, FL, GA, IA, ID, IL, IN, IO, KS, LA, MA, MD, MI, MN, MO, NC, NY, OH, PA, SC, TN, TX, UT, VA, WI, and WV; and countries of: Australia, Brazil, Canada, Dubai, Germany, Japan, Kuwait, Malaysia, New Zealand, Saudi Arabia, Singapore, South Africa, Taiwan, and Thailand.","Z-0132-2014","Class II","DRX Revolution, Catalog #'s 1)1019397, 2) 1023415 (w/ installation warranty, US-only) and 3) 1023423 (w/ parts warranty, US-only). The device is designed to perform radiographic x-ray examinations on all pediatric and adult patients, in all patient treatment areas","Serial Numbers: All serial numbers manufactured since inception in June 21, 2012 until June 12, 2013",".","331 units","Carestream Health Inc. is conducting a recall for the Column end Cover present on the DRX Revolution Mobile X-Ray System due to the cover dislodging from the column. ",6/19/2013,"06/19/2013",11/13/2013,"11/13/2013"
"Food",65587,"Ongoing","Church & Dwight Inc","Princeton","NJ","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Nationwide","F-1754-2013","Class II","Arm & Hammer Baking Soda a) Net Wt. 1 LB. (454 g) UPC 3320001130 b) Net Wt. 8 oz. (277 g) UPC 3320001110 Church & Dwight, Co. Inc. 469 N. Harrison Street Princeton, NJ 08543-5297 USA","Lot FF3153 Lot FF3154",,"8 oz. - 332 cases; 1lb. - 729 cases","Church and Dwight Co., Inc. has initiated a recall for Sodium Bicarbonate, USP produced by the Old Fort, OH Sodium Bicarbonate Production facility due to metal and other contamination.",6/12/2013,"06/12/2013",8/7/2013,"08/07/2013"
"Drugs",65588,"Ongoing","Fresenius Kabi USA, LLC","Lake Zurich","IL","US","Voluntary: Firm Initiated","Letter","Nationwide & Puerto Rico","D-685-2013","Class II","Benztropine Mesylate Injection, USP, 2 mg/2 mL (1 mg/1 mL), 2 mL Single Dose Vial, Rx only, labeled as a) Manufactured for: APP Pharmaceuticals, LLC, Schaumburg, IL 60173, NDC 63323-970-02; and b) Manufactured in the USA for Nexus Pharmaceuticals Inc., Vernon Hills, IL 60061, NDC 14789-300-02","a) Lot: 111412, Exp: 11/2014 b) Lots: 030712, Exp: 03/2014; 071212, Exp: 07/2014; 090512, Exp: 09/2014; ",".","65110 vials","Presence of particulate matter: characterized as thin colorless flakes that are visually and chemically consistent with glass delamination observed in reserve sample vials",7/1/2013,"07/01/2013",7/17/2013,"07/17/2013"
"Devices",65590,"Ongoing","Intuitive Surgical, Inc.","Sunnyvale","CA","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution - USA including UT, CA, AZ, CO, FL, HI. MT, NY,TX and WA and one customer in Russia.","Z-1688-2013","Class II","da Vinci Dual Camera Controller, model number DC3000; Manufactured by Intuitive Surgical, Sunnyvale, CA 94086. Intuitive Surgical endoscopic Instrument Control System is intended to assist in the accurate control of Intuitive Surgical Endoscopic instruments. It is intended for adult and pediatric use.","Part number 372019-01: Serial numbers: 323943 323895 323882 323945 323994 323804 323979 323987 324042 324086. ",".","30 total, all devices","Factory testing on da Vinci Si Surgical Systems may not be in compliance with UL Standards as one of the testing devices was found to be working incorrectly.",6/8/2013,"06/08/2013",7/17/2013,"07/17/2013"
"Devices",65590,"Ongoing","Intuitive Surgical, Inc.","Sunnyvale","CA","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution - USA including UT, CA, AZ, CO, FL, HI. MT, NY,TX and WA and one customer in Russia.","Z-1686-2013","Class II","da Vinci Si Surgeon Side Cart, model number SS3000; Manufactured by Intuitive Surgical, Sunnyvale, CA 94086. Intuitive Surgical endoscopic Instrument Control System is intended to assist in the accurate control of Intuitive Surgical Endoscopic instruments. It is intended for adult and pediatric use.","Part number 380610-15: Serial numbers: 323936 323937 325082 325143 325175 325178 325355 325290 325352 325669 325672 325692 325444 325446 325447 325583 325585 325587 325634 325671 325684 325720 325724 325719 325888 325465 325549 325266 325268 323875 324092 324098 324100 324190 324258 324260 324265 324370 324425 324426 324528 324585 324586 324638 324649 324847 324848 324849 325076 ",".","30 total, all devices","Factory testing on da Vinci Si Surgical Systems may not be in compliance with UL Standards as one of the testing devices was found to be working incorrectly.",6/8/2013,"06/08/2013",7/17/2013,"07/17/2013"
"Devices",65590,"Ongoing","Intuitive Surgical, Inc.","Sunnyvale","CA","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution - USA including UT, CA, AZ, CO, FL, HI. MT, NY,TX and WA and one customer in Russia.","Z-1687-2013","Class II","da Vinci Si Vision System Cart, model number VS3000; Manufactured by Intuitive Surgical, Sunnyvale, CA 94086. Intuitive Surgical endoscopic Instrument Control System is intended to assist in the accurate control of Intuitive Surgical Endoscopic instruments. It is intended for adult and pediatric use.","Part number 380990-11: Serial numbers: 324350 325289 325301 325858 325872 325686 325700 325639 325646 324537 324566 324087 324577 324772 324784 324948 325126 325279 325138 325621 325441 325453 325564 323865 323870 323977 324010 324014 324334. ",".","30 total, all devices","Factory testing on da Vinci Si Surgical Systems may not be in compliance with UL Standards as one of the testing devices was found to be working incorrectly.",6/8/2013,"06/08/2013",7/17/2013,"07/17/2013"
"Devices",65590,"Ongoing","Intuitive Surgical, Inc.","Sunnyvale","CA","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution - USA including UT, CA, AZ, CO, FL, HI. MT, NY,TX and WA and one customer in Russia.","Z-1689-2013","Class II","da Vinci Instrument Control Box, model number ICB3000; Manufactured by Intuitive Surgical, Sunnyvale, CA 94086. Intuitive Surgical endoscopic Instrument Control System is intended to assist in the accurate control of Intuitive Surgical Endoscopic instruments. It is intended for adult and pediatric use.","Part number 372012-96: Serial numbers: 323986 324198. ",".","30 total, all devices","Factory testing on da Vinci Si Surgical Systems may not be in compliance with UL Standards as one of the testing devices was found to be working incorrectly.",6/8/2013,"06/08/2013",7/17/2013,"07/17/2013"
"Devices",65591,"Ongoing","DePuy Orthopaedics, Inc.","Warsaw","IN","US","Voluntary: Firm Initiated","E-Mail","Worldwide Distribution-USA including the states of FL, GA, ID, KS, KY, MI, MO, NV, NY, OH, OK, PA, TN, TX, VA, and WA and the countries of AUSTRALIA, CANADA, ENGLAND, GERMANY, INDIA, COUNTY CORK, IRELAND, and TURKEY.","Z-1820-2013","Class I","LPS Lower Extremity Dovetail Intercalary component. Intended for use in replacement of the mid-shaft portion of the femur. ","CATALOG NO. : Part Number: 1987-19-055 and lot numbers:130896, 132131, 132133, 209461, 209466, 219843, 232972, 295965, 310189, 336843, 349283, 352878, 374125, 379089, A1TAR1, A2AGN1, A2AGS1, A2AGT1, A2AGV1, B2VAL1, B43G11, B43G1A, B43G1B, B43G1C, B43G1D, B69HV1, B69HVA, BK1BB1, BW7DX1, BW7DX1A, E3SJD1, and EN4KJ1. In certain documentation, these alphanumeric lot numbers may appear with three zeros at the end (e.g. A1TAR1 may appear as A1TAR1000). ",,"57 U.S. / 37 OUS","The LPS Lower Extremity Dovetail Intercalary component has the potential for fracture of the female component when exposed to certain physiological loads.",7/11/2013,"07/11/2013",8/7/2013,"08/07/2013"
"Food",65592,"Ongoing","Talenti Gelato","Marietta","GA","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Alaska, CT, ID, IL, IN, MD, MA, MT, NH, NJ, NY, NC, OH, PA, TN, VA, WA and WI.","F-1717-2013","Class II","Talenti Gelato, Toasted Almond, One Pint (473ml), Crafted by: Talenti, Marietta, GA 30062","Lot #: 11/15/2014 M1, UPC #:1 86852 00039 6",".","420 Cases/3360 units.","Product contains undeclared Allergen; Pecans.",6/25/2013,"06/25/2013",7/24/2013,"07/24/2013"
"Biologics",65593,"Terminated","Arc Blood Services, New England Region","Dedham","MA","US","Voluntary: Firm Initiated","E-Mail","Connecticut","B-2291-13","Class II","Red Blood Cells Leukocytes Reduced","033FL20861; 033FS00741; ",".","2 units","Blood products, collected from an ineligible donor, were distributed. ",5/20/2013,"05/20/2013",9/18/2013,"09/18/2013"
"Biologics",65593,"Terminated","Arc Blood Services, New England Region","Dedham","MA","US","Voluntary: Firm Initiated","E-Mail","Connecticut","B-2292-13","Class II","Platelets Pooled Leukocytes Reduced","033Z08175; ",".","1 unit","Blood products, collected from an ineligible donor, were distributed. ",5/20/2013,"05/20/2013",9/18/2013,"09/18/2013"
"Biologics",65593,"Terminated","Arc Blood Services, New England Region","Dedham","MA","US","Voluntary: Firm Initiated","E-Mail","Connecticut","B-2290-13","Class II","Platelets Leukocytes Reduced","033FL20861; ",".","1 unit","Blood products, collected from an ineligible donor, were distributed. ",5/20/2013,"05/20/2013",9/18/2013,"09/18/2013"
"Biologics",65594,"Terminated","Wellmont Health System Dba Marsh Regional Blood Center","Kingsport","TN","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Tennessee; Virginia; Maryland","B-2303-13","Class II","Fresh Frozen Plasma","W241213500713; W241212200249; ",,"2","Blood products, collected from a donor who reported testing positive for hepatitis, were distributed",6/3/2013,"06/03/2013",9/25/2013,"09/25/2013"
"Biologics",65594,"Terminated","Wellmont Health System Dba Marsh Regional Blood Center","Kingsport","TN","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Tennessee; Virginia; Maryland","B-2304-13","Class II","Red Blood Cells Leukocytes Reduced"," W241212200429; ; ",,"1","Blood products, collected from a donor who reported testing positive for hepatitis, were distributed",6/3/2013,"06/03/2013",9/25/2013,"09/25/2013"
"Biologics",65594,"Terminated","Wellmont Health System Dba Marsh Regional Blood Center","Kingsport","TN","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Tennessee; Virginia; Maryland","B-2305-13","Class III","Blood and Blood Products for Reprocessing","W241211501914; W241212200429; W241212200760; W241212200943; ",,"4","Blood products, collected from a donor who reported testing positive for hepatitis, were distributed",6/3/2013,"06/03/2013",9/25/2013,"09/25/2013"
"Biologics",65595,"Terminated","Merck Sharpe & Dohme Corp","West Point","PA","US","Voluntary: Firm Initiated","Letter","Multiple U.S. States","B-2190-13","Class III","Measles, Mumps and Rubella Virus Vaccine Live","0851AA",".","1 Batch; 39,340 vials","M-M-R II (Measles, Mumps and Rubella Virus Vaccine Live)was inadvertently distributed. ",6/12/2012,"06/12/2012",9/11/2013,"09/11/2013"
"Biologics",65596,"Terminated","Michigan Blood","Saginaw","MI","US","Voluntary: Firm Initiated","FAX","Michigan","B-2306-13","Class II","Platelets Pooled Leukocytes Reduced Irradiated","W120613380530; ",,"1","Blood product, which did not meet the acceptable product specification for release, was distributed. ",5/6/2013,"05/06/2013",9/25/2013,"09/25/2013"
"Biologics",65597,"Terminated","Ogden Medical Center, Inc.","Ogden","UT","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Utah","B-2307-13","Class II","Red Blood Cells","W116512721632Y; W1165125034825; W116512503382D; ",,"3","Blood products, which were collected from a donor who traveled to a malarial endemic area, were distributed",2/12/2013,"02/12/2013",9/25/2013,"09/25/2013"
"Biologics",65597,"Terminated","Ogden Medical Center, Inc.","Ogden","UT","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Utah","B-2308-13","Class II","Red Blood Cells Leukocytes Reduced","W1165115028930; ",,"1","Blood products, which were collected from a donor who traveled to a malarial endemic area, were distributed",2/12/2013,"02/12/2013",9/25/2013,"09/25/2013"
"Biologics",65598,"Terminated","DCI Biologicals, LLC","Jacksonville","FL","US","Voluntary: Firm Initiated","FAX","United Kingdom","B-2309-13","Class II","Source Plasma","JK0443489; JK0449951; JK0450409; JK0451626; JK0451960; JK0459403; JK0459850; JK0460471; JK0460935; JK0461584; JK0462093; JK0464244; JK0464515; JK0417096; ",,"14","Blood products, collected from a donor who was at risk for variant Creutzfeldt-Jakob Disease (vCJD), were distributed",5/23/2013,"05/23/2013",9/25/2013,"09/25/2013"
"Biologics",65599,"Terminated","University Of Miami Miller School of Medicine Tissue Bank","Miami","FL","US","Voluntary: Firm Initiated","Telephone","Mississippi; Puerto Rico; Maryland; Florida; Guatemala; New York","B-2183-13","Class II","Bone","0111510146; 0111510147; 0111510148; 0111510131; 0111510132; 0111510133; 0111510134; 0111510135; 0111510136; 0111510137; 0111510138; 0111510139; 0111510140; 0111510066; 0111510068; 0111510070; 0111510071; 0111510072; 0111510073; 0111510074; 0111510075; 0111510076; 0111510077; 0111510078; 0111510079; 0111510080; 0111510081; 0111510082; 0111510083; 0111510091; 0111510096; 0111510097; 0111510098; 0111510099; 0111510100; 0111510101; 0111510102; 0111510103; 0111510104; 0111510105; 0111510106; 0111510107; 0111510108; 0111510109; 0111510110; 0111510111; 0111510112; 0111510113; 0111510114; 0111510115; 0111510121; 0111510123; 0111510150; 0111510152; 0111510153; 0111510154; 0111510119; 0111510149; 0112840072; 0112840073; 0112840074; 0112840075; 0112840076; 0112840077; 0112840078; 0112840080; 0112840081; 0112840086; 0112840082; 0112840085; ",".","70 bone allografts","Human tissue allografts, associated with positive culture results, were distributed. ",4/23/2013,"04/23/2013",9/11/2013,"09/11/2013"
"Devices",65600,"Ongoing","Medtronic Neurosurgery","Goleta","CA","US","Voluntary: Firm Initiated","Letter","Nationwide Distribution in the US.","Z-1810-2013","Class II","Medtronic Preimplantation Test Kit, Catalog No. 21047. The kit is indicated for use with Medtronic CSF-Flow Control Valves and Delta Valves, when a simple preimplantation test is desired to verify that the valve conforms to labeled product specifications.","C22929 C40543 C56465 C80034 D16291 C25329 C42910 C57924 C80787 D16693 C25475 C43115 C62128 D00052 D20967 C25662 C43512 C65929 D01033 D22544 C28396 C45615 C66120 D07250 D25802 C29229 C46351 C68906 D07373 D30597 C33946 C46583 C69701 D07507 C36893 C49439 C71003 D10462 C36904 C49706 C73622 D11409 C38718 C51418 C76639 D13208 C39484 C52417 C78186 D14099 C40150 C53058 C79051 D16157",,"915 units","Medtronic Neurosurgery is recalling the Medtronic Preimplantation Test Kit because the outer carton had expiration dates that were incorrect. The date on the outer carton is later than the expiration date for one or more of the individually packaged sterile components in the kit.",6/28/2013,"06/28/2013",7/31/2013,"07/31/2013"
"Drugs",65601,"Completed","Physicians Total Care, Inc.","Tulsa","OK","US","Voluntary: Firm Initiated","FAX","GA","D-826-2013","Class II","Belladonna Alkaloids/PB (Belladonna Alkaloids / Phenobarbital) Tablets Phenobarbital USP 16.2 mg, Hyoscyamine Sulfate 0.1037 mg, Atropine Sulfate 0.0194 mg, Scopolamine Hydrobromide 0.0065 mg 30-count bottle (NDC 54868-0031-04), Rx only, Repackaged and distributed by Physicians Total Care, Inc. Tulsa, OK 74146. ","Lot# 6GP2; Exp 10/14 West-Ward Lot /WWCN 67331A",,"270 tablets","Presence of Foriegn Substance:The manufacturer, West-ward Pharmaceutical, recalled product because of the presence of black spots on tablets. In response, the repackager initiated its own recall.",6/17/2013,"06/17/2013",8/7/2013,"08/07/2013"
"Food",65602,"Ongoing","Ocean State Jobbers, Inc.","North Kingstown","RI","US","Voluntary: Firm Initiated","E-Mail","Rhode Island, Massachusetts, Connecticut, New Hampshire, Vermont and Maine, New York","F-0708-2014","Class II","Mediterranean Olives: Calcidica Sweet, produced by Bel Frantoio and packaged in 34-oz. plastic containers. Imported from Italy","All lot numbers 297-2012 342-2012 038-2013 039-2013 065-2013 ",".","1356 units","Product stored at room temperature not as per label instructions ''Keep refrigerated''",6/28/2013,"06/28/2013",12/11/2013,"12/11/2013"
"Food",65602,"Ongoing","Ocean State Jobbers, Inc.","North Kingstown","RI","US","Voluntary: Firm Initiated","E-Mail","Rhode Island, Massachusetts, Connecticut, New Hampshire, Vermont and Maine, New York","F-0717-2014","Class II","Mediterranean Olives: Cracked Cerignole, produced by Bel Frantoio and packaged in 34-oz. plastic containers. Imported from Italy","All lot numbers 297-2012 342-2012 038-2013 039-2013 065-2013 ",".","2832 units","Product stored at room temperature not as per label instructions ''Keep refrigerated''",6/28/2013,"06/28/2013",12/11/2013,"12/11/2013"
"Food",65602,"Ongoing","Ocean State Jobbers, Inc.","North Kingstown","RI","US","Voluntary: Firm Initiated","E-Mail","Rhode Island, Massachusetts, Connecticut, New Hampshire, Vermont and Maine, New York","F-0714-2014","Class II","Mediterranean Olives: Gaeta White, produced by Bel Frantoio and packaged in 34-oz. plastic containers. Imported from Italy","All lot numbers 297-2012 342-2012 038-2013 039-2013 065-2013 ",".","4536 units","Product stored at room temperature not as per label instructions ''Keep refrigerated''",6/28/2013,"06/28/2013",12/11/2013,"12/11/2013"
"Food",65602,"Ongoing","Ocean State Jobbers, Inc.","North Kingstown","RI","US","Voluntary: Firm Initiated","E-Mail","Rhode Island, Massachusetts, Connecticut, New Hampshire, Vermont and Maine, New York","F-0718-2014","Class II","Mediterranean Olives: French Picholine, produced by Bel Frantoio and packaged in 34-oz. plastic containers. Imported from Italy","All lot numbers 297-2012 342-2012 038-2013 039-2013 065-2013 ",".","1404 units","Product stored at room temperature not as per label instructions ''Keep refrigerated''",6/28/2013,"06/28/2013",12/11/2013,"12/11/2013"
"Food",65602,"Ongoing","Ocean State Jobbers, Inc.","North Kingstown","RI","US","Voluntary: Firm Initiated","E-Mail","Rhode Island, Massachusetts, Connecticut, New Hampshire, Vermont and Maine, New York","F-0716-2014","Class II","Mediterranean Olives: Dry Morrocan, produced by Bel Frantoio and packaged in 34-oz. plastic containers. Imported from Italy","All lot numbers 297-2012 342-2012 038-2013 039-2013 065-2013 ",".","2832 units","Product stored at room temperature not as per label instructions ''Keep refrigerated''",6/28/2013,"06/28/2013",12/11/2013,"12/11/2013"
"Food",65602,"Ongoing","Ocean State Jobbers, Inc.","North Kingstown","RI","US","Voluntary: Firm Initiated","E-Mail","Rhode Island, Massachusetts, Connecticut, New Hampshire, Vermont and Maine, New York","F-0713-2014","Class II","Mediterranean Olives: Small, produced by Bel Frantoio and packaged in 34-oz. plastic containers. Imported from Italy","All lot numbers 297-2012 342-2012 038-2013 039-2013 065-2013 ",".","4296 units","Product stored at room temperature not as per label instructions ''Keep refrigerated''",6/28/2013,"06/28/2013",12/11/2013,"12/11/2013"
"Food",65602,"Ongoing","Ocean State Jobbers, Inc.","North Kingstown","RI","US","Voluntary: Firm Initiated","E-Mail","Rhode Island, Massachusetts, Connecticut, New Hampshire, Vermont and Maine, New York","F-0711-2014","Class II","Mediterranean Olives: Black, produced by Bel Frantoio and packaged in 34-oz. plastic containers. Imported from Italy","All lot numbers 297-2012 342-2012 038-2013 039-2013 065-2013 ",".","8172 units","Product stored at room temperature not as per label instructions ''Keep refrigerated''",6/28/2013,"06/28/2013",12/11/2013,"12/11/2013"
"Food",65602,"Ongoing","Ocean State Jobbers, Inc.","North Kingstown","RI","US","Voluntary: Firm Initiated","E-Mail","Rhode Island, Massachusetts, Connecticut, New Hampshire, Vermont and Maine, New York","F-0720-2014","Class II","Mediterranean Olives: Large, produced by Bel Frantoio and packaged in 34-oz. plastic containers. Imported from Italy","All lot numbers 297-2012 342-2012 038-2013 039-2013 065-2013 ",".","5,448 units","Product stored at room temperature not as per label instructions ''Keep refrigerated''",6/28/2013,"06/28/2013",12/11/2013,"12/11/2013"
"Food",65602,"Ongoing","Ocean State Jobbers, Inc.","North Kingstown","RI","US","Voluntary: Firm Initiated","E-Mail","Rhode Island, Massachusetts, Connecticut, New Hampshire, Vermont and Maine, New York","F-0712-2014","Class II","Mediterranean Olives: Green Stuffed, produced by Bel Frantoio and packaged in 34-oz. plastic containers. Imported from Italy","All lot numbers 297-2012 342-2012 038-2013 039-2013 065-2013 ",".","8052 units","Product stored at room temperature not as per label instructions ''Keep refrigerated''",6/28/2013,"06/28/2013",12/11/2013,"12/11/2013"
"Food",65602,"Ongoing","Ocean State Jobbers, Inc.","North Kingstown","RI","US","Voluntary: Firm Initiated","E-Mail","Rhode Island, Massachusetts, Connecticut, New Hampshire, Vermont and Maine, New York","F-0715-2014","Class II","Mediterranean Olives: Gaeta Black, produced by Bel Frantoio and packaged in 34-oz. plastic containers. Imported from Italy","All lot numbers 297-2012 342-2012 038-2013 039-2013 065-2013 ",".","4536 units","Product stored at room temperature not as per label instructions ''Keep refrigerated''",6/28/2013,"06/28/2013",12/11/2013,"12/11/2013"
"Food",65602,"Ongoing","Ocean State Jobbers, Inc.","North Kingstown","RI","US","Voluntary: Firm Initiated","E-Mail","Rhode Island, Massachusetts, Connecticut, New Hampshire, Vermont and Maine, New York","F-0719-2014","Class II","Mediterranean Olives: Kalamata, produced by Bel Frantoio and packaged in 34-oz. plastic containers. Imported from Italy","All lot numbers 297-2012 342-2012 038-2013 039-2013 065-2013 ",".","6216 units","Product stored at room temperature not as per label instructions ''Keep refrigerated''",6/28/2013,"06/28/2013",12/11/2013,"12/11/2013"
"Devices",65603,"Ongoing","Siemens Medical Solutions USA, Inc","Malvern","PA","US","Voluntary: Firm Initiated","Letter","US Distribution only including the states of PA, OH, UT, CA, NY, MO, and TX.","Z-1859-2013","Class II","syngo Dynamics Information System (sDIS) versions 9.5 and VA10A. The syngo Dynamics system is intended for the acceptance, transfer, display, storage, archive, and manipulation of digital medical images, including quantification and reportgeneration. syngo Dynamics is not intended to be used for reading mammography images.","Model Number: 10091637, 10091805, with serial numbers 85164, 85289, 85296, 85297, 85149, 85116, 85177, 85051, and 85278.",,"9","Siemens initiate this recall due to a potential issue when using the sDIS matching rules of the syngo Dynamics Information System version 9.5 or VA10A with modality device configured to end study at association close. Images or DICOM SR objects sent from a modality device to syngo Dynamics may not be saved when the modality is configured at syngo Dynamics to end study at association close, and when sDIS matching rules are in effect. The risk is that a study may be missing some of its images and/or DICOM SR objects and there is no indication to the user that images and/or SR objects are missing from the study.",6/10/2013,"06/10/2013",8/7/2013,"08/07/2013"
"Devices",65604,"Ongoing","Siemens Medical Solutions USA, Inc","Malvern","PA","US","Voluntary: Firm Initiated","Letter","Nationwide Distribution.","Z-1795-2013","Class II","Axiom Aristos MX Solid State Flat Panel Digital Imager, Model number 5895003. The device is used for diagnostic X-ray imaging.","Model Number 5895003 with serial numbers 1052 through 2500. ",,"401","Siemens issued a Field Safety Notice about the potential hazard to patients or operators when using the function ''table top float'' of the AXIOM Aristos MX. When repositioning a patient lying on the table top and releasing the table top, it is possible that the fingers of the patient or operator are between the table top and the detector tray and if the table top is moved, the fingers can be squeezed. ",6/5/2013,"06/05/2013",7/31/2013,"07/31/2013"
"Devices",65605,"Ongoing","Siemens Medical Solutions USA, Inc","Malvern","PA","US","Voluntary: Firm Initiated","Letter","US Distribution including the states of IA, SD, NC, WI, OH, NE, TX, KS, ID, MI, GA, AR and IL.","Z-1875-2013","Class II","Mobiletta Mira Mobile X-ray System","Model number 10273100",".","39","Siemens issued a Field Safety Alert about the potential risk to users when operating the Mobilett Mira. When a Mobilett Mira is regularly exposed to extensive mechanical strain (driven over high thresholds for doors or elevators), it is possible that one of its main wheel shafts could break because of material fatigue, resulting in the chassis falling on the ground on the affected wheel side. This imposes a potential risk of squeezing the toes of the user or another person. ",5/2/2013,"05/02/2013",8/14/2013,"08/14/2013"
"Drugs",65606,"Ongoing","Earthlabs, Inc. DBA Wise Woman Herbals","Creswell","OR","US","Voluntary: Firm Initiated","Telephone","Nationwide","D-912-2013","Class II","Eyebright Concentrate Topical Eye Rinse, 1, 2, 4, 8, 16 & 32 fl oz bottles, Produced and distributed by: Wise Woman Herbals, Creswell, OR","Lot# 10010 Best used by: 07/14/13 Lot# 10285 Best used by: 02/16/14 Lot# 10640 Best used by: 11/09/14 Lot# 11107 Best used by: 09/16/15 Lot# 11408 Best used by: 05/04/16 Lot# 11711 Best used by: 11/23/16 Lot# 12088 Best used by: 09/04/17 Each lot number has various sizes Product numbers - 1EDCO, 2EDCO, 4EDCO, 8EDCO, 16EDCO, 32EDCO 1 (indicates package size) ED (indicates Eyebright) CO (indicates compound (blended from other finished products) Container sizes - Stock: 1 oz., 2 oz., 4 oz. Non-stock: 8 oz., 16 oz., 32 oz.",".","581x1oz bottles, 263x2 oz bottles, 20x4 oz bottles, 2x8 oz bottles, 1x16 oz bottle, 1x32 oz bottle","Lack of Assurance of Sterility; Lack of Assurance of Sterility; product not manufactured under sterile conditions as required for ophthalmic drug products",5/27/2013,"05/27/2013",8/28/2013,"08/28/2013"
"Devices",65607,"Ongoing","Siemens Healthcare Diagnostics, Inc.","Newark","DE","US","Voluntary: Firm Initiated","Letter","Worldwide distribution: US (nationwide) including PR and countries of: Australia, Austria, Belgium, Canada, Czech Republic, Denmark, Finland, France, Germany, Italy, Japan, Malaysia, Netherlands, New Zealand, Norway, Portugal, Republic Korea, Saudia Arabia, Slovakia, Slovenia, South Africa, Spain, Switzerland, and United Kingdom.","Z-2088-2013","Class II","Dimension Vista 500 and Dimension Vista 1500 System Aliquot Well Double Dispense with software versions 3.5.1 and 3.6. In vitro diagnostic device intended to duplicate manual analytical procedures such as pipetting, mixing, heating, and measuring spectral intensities to determine a variety of analytes in human body fluids. Dimension Vista chemical and immunochemical applications use photometric, turbidimetric, chemiluminescence, nephelometric, and integrated ion-selective multisensory technology for clinical use. ","Dimension Vista 500 Siemens material numbers: 10284473 (domestic), and 10488224 (international), Dimension Vista 1500 Siemens material numbers: 10444801 (domestic) and 10444802 (international). ",,"1937","Siemens is conducting a field correction for Dimension Vista 500 and Dimension Vista 1500 systems using software versions 3.5.1 and 3.6. Under specific rare conditions which require a system reset, there is a potential for a sample to be dispensed into an aliquot well that has previously been used for a QC or calibrator product from a Vista vial. If two samples are dispensed into the same aliquot well, the first sample will always be QC or calibrator from a Vista vial. Patient sample will never be dispensed into an aliquot well that contains another patient sample. The possible combinations are 1.) patient sample dispensed on QC or calibrator from a Vista vial, 2) QC from a Vista vial or any other sample container dispensed on QC or calibrator from a Vista vial, and 3) Calibrator from a Vista vial or any other sample container dispensed on QC or calibrator from a Vista vial. ",6/19/2013,"06/19/2013",9/4/2013,"09/04/2013"
"Food",65608,"Ongoing","Harmony Chai","Eastsound","WA","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Retail stores, one farmers' market in Washington State, and two internet customers in Washington State","F-1847-2013","Class II","Acidified Tea in a glass bottle with a multi-colored, stick-on label that reads in part: '' HARMONY Chai Decaffeinated Fresh brewed on Orcas Island, WA Rooibos Chai 22oz. (624,25ml)***Ingredients: water, Organic Raw Sugar, Rooibos Tea, cloves, cinnamon, Ginger, secret spices, citric Acid***7 94504 02431 9***'' There is also a larger size with the same labeling except: ''*** 64oz. (1892.70ml)***7 05105 01301 5***'' ","22 oz. Rooibos Chai: 7 94504 02431 9 64 oz. Rooibos Chai: 7 05105 01301 5 The recall involved all lot codes.",".","not available","Product not properly processed",6/24/2013,"06/24/2013",8/28/2013,"08/28/2013"
"Food",65608,"Ongoing","Harmony Chai","Eastsound","WA","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Retail stores, one farmers' market in Washington State, and two internet customers in Washington State","F-1846-2013","Class II","Acidified Tea in a glass bottle with a multi-colored, stick-on label that reads in part: '' HARMONY Chai concentrated Fresh brewed on Orcas Island, WA Black Spiced Chai 22oz. (650 ml)***Ingredients: water, Organic Raw Sugar, Black Tea, cloves, cinnamon, Ginger, secret spices, citric Acid***7 05105 01311 4***'' There is also a larger size with the same labeling except: ''*** 64oz. (1892.70ml)***7 05105 01301 5***'' ","22 oz. Black Spiced Chai: 7 05105 01311 4 64 oz. Black Spiced Chai: 7 05105 01301 5 The recall involved all lot codes.",".","not availble","Product not properly processed",6/24/2013,"06/24/2013",8/28/2013,"08/28/2013"
"Devices",65609,"Ongoing","Siemens Healthcare Diagnostics","Tarrytown","NY","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution - USA Nationwide including Puerto Rico and the countries of: Albania, Afghanistan, Algeria, Argentina, Austria, Bangladesh, Belgium, Bolivia, Bosnia- Herzegovinia, Brazil, Bulgaria, Camaroon, Canada, Canary Islands, Chile, China, Colombia, Coast Croatia, Cyprus, Czech Republic, Denmark, Dominican Republic, Ecuador, Egypt, El Salvador, Estonia, Finland, France, Germany, Great Britain, Greece, Guatemala, Honduras, Hungary, India, Iran, Ireland, Israel, Italy, Japan, Jordan, Kazakhstan, Latvia, Lebanon, Lithuania, Macedonia, Malaysia, Malta, Mexico, Morocco, Nicaragua, Oman, Pakistan, Panama, Paraguay, Peru, Philippines, Poland, Portugal, Romania, Russian Federation, Saudi Arabia, Serbia, Slovakia, Slovenia, Spain, South Africa, Rep. of Korea (S), Sweden, Switzerland, Syria, Taiwan, Thailand, The Netherlands, Tunisia, Turkey, Turkmenistan, Ukraine, United Arab Emirates, Uruguay, White Russia, Venezuela, and Vietnam.","Z-2047-2013","Class II","PSA Assays for use in the IMMULITE/IMMULITE 1000 Systems Analyzers, Catalog Numbers LKPS1, LKPS5 and LKPTS1(D); and in the IMMULITE 2000/2000XPi Systems Analyzers, Catalog Numbers L2KPS2, L2KPS6, L2KPTS2(D) and L2KPTS6(D). IVD Immunoassay kits in the following sizes: 100, 200, 500 and 600 test kits; For in vitro diagnostic use with the IMMULITE/IMMULITE 1000 and the IMMULITE 2000/ 2000 XPi Systems Analyzers. PMA # P930027/ Device Listing # D002374. Product Usage: For the quantitative measurement of prostate-specific antigen (PSA) in human serum, as an aid in the detection of prostate cancer when used in conjunction with digital rectal examination (DRE) in men aged 50 years or older. This assay is further indicated as an adjunctive test to aid in the management of prostate cancer patients. For in vitro diagnostic use with the IMMULITE/IMMULITE 1000 and the IMMULITE 2000/ 2000 XPI Systems Analyzers ","Product Code/Lot # LKPS1 424, Expiration Date 2013-08-31; Product Code/Lot # LKPS1 425, Expiration Date 2013-10-31; Product Code/Lot # LKPS1 426, Expiration Date 2013-10-31; Product Code/Lot # LKPS5 424, Expiration Date 2013-08-31; Product Code/Lot # LKPS5 425, Expiration Date 2013-10-31; Product Code/Lot # LKPS5 426, Expiration Date 2013-10-31; Product Code/Lot # LKPTS1(D) D0104, Expiration Date 2013-08-31; Product Code/Lot # L2KPS2 379, Expiration Date 2013-07-31; Product Code/Lot # L2KPS2 380, Expiration Date 2013-08-31; Product Code/Lot # L2KPS2 381, Expiration Date 2013-10-31; Product Code/Lot # L2KPS2 382, Expiration Date 2013-10-31; Product Code/Lot # L2KPS2 383, Expiration Date 2013-10-31; Product Code/Lot # L2KPS2 384, Expiration Date 2013-10-31; Product Code/Lot # L2KPS6 379, Expiration Date 2013-07-31; Product Code/Lot # L2KPS6 380, Expiration Date 2013-08-31; Product Code/Lot # L2KPS6 381, Expiration Date 2013-10-31; Product Code/Lot # L2KPS6 382, Expiration Date 2013-10-31; Product Code/Lot # L2KPS6 383, Expiration Date 2013-10-31; Product Code/Lot # L2KPS6 384, Expiration Date 2013-10-31; Product Code/Lot # L2KPTS2(D) D107, Expiration Date 2013-07-31; Product Code/Lot # L2KPTS2(D) D108, Expiration Date 2013-10-31; Product Code/Lot # L2KPTS2(D) D109, Expiration Date 2013-10-31; Product Code/Lot # L2KPTS6(D) D107, Expiration Date 2013-07-31; Product Code/Lot # L2KPTS6(D) D108, Expiration Date 2013-10-31; Product Code/Lot # L2KPTS6(D) D109, Expiration Date 2013-10-31.",,"24,361 kits","Customers complained of a positive bias in patient results on the IMMULITE/ IMMULITE 1000 and the IMMULITE 2000/ 2000 XPi PSA assay when compared against the IMMULITE /IMMULITE 1000 3rd Generation PSA assay. Siemens has confirmed an overall average positive bias of approximately 20% to 23% across the assay range relative to the WHO 96/670 with the IMMMULITE Systems PSA Assay. This positive bias is observed in patient values and the Siemens Tumor Marker controls (TMCO). Other commercially available controls may show this bias.",6/26/2013,"06/26/2013",9/4/2013,"09/04/2013"
"Devices",65610,"Ongoing","Hospira Inc.","Lake Forest","IL","US","Voluntary: Firm Initiated","Letter","US Distribution including the states of AL, CA, CT, DE, FL, HI, IA, IL, IN, LA, MA, MD, ME, MI, MN, NC, NJ, NY, PA, SD, TX and WA.","Z-1847-2013","Class II","The Hospira Symbiq Infusion System is intended for the delivery of fluids, solutions, drugs, agents, nutritionals, electrolytes, blood and blood products via parenteral, enteral, intravenous, intra-arterial, subcutaneous, epidural, or irrigation routes of administration. ","*** 1) List Number 16206, Serial Numbers: 0017234975 , 0017234978 , 0017234979 , 0017234980 , 0017234981 , 0017234982 , 0017234983 , 0017234984 , 0017234985 , 0017234986 , 0017234988 , 0017234991 , 0017234992 , 0017234993 , 0017234994 , 0017234995 , 0017234996 , 0017234997 , 0017234998 , 0017234999 , 0017235001 , 0017235002 , 0017235003 , 0017235004 , 0017235005 , 0017235006 , 0017235007 , 0017235008 , 0017235009 , 0017235010 , 0017235011 , 0017235014 , 0017235015 , 0017235016 , 0017235017 , 0017235018 , 0017235019 , 0017235020 , 0017235021 , 0017235022 , 0017235023 , 0017235024 , 0017235025 , 0017235026 , 0017235028 , 0017235029 , 0017235030 , 0017235031 , 0017235032 , 0017235033 , 0017235034 , 0017235035 , 0017235036 , 0017235037 , 0017235038 , 0017235039 , 0017235041 , 0017235042 , 0017235043 , 0017235044 , 0017235045 , 0017235046 , 0017235048 , 0017235049 , 0017235050 , 0017235051 , 0017235052 , 0017235053 , 0017235054 , 0017235056 , 0017235057 , 0017235058 , 0017235060 , 0017235062 , 0017235063 , 0017235064 , 0017235065 , 0017235066 , 0017235067 , 0017235068 , 0017235069 , 0017235070 , 0017235071 , 0017235073 , 0017235074 , 0017235076 , 0017235077 , 0017235079 , 0017235080 , 0017235081 , 0017235082 , 0017235083 , 0017235084 , 0017235085 , 0017235086 , 0017235087 , 0017235088 , 0017235089 , 0017235090 , 0017235091 , 0017235093 , 0017235094 , 0017235095 , 0017235096 , 0017235097 , 0017235098 , 0017235099 , 0017235101 , 0017235103 , 0017235104 , 0017235105 , 0017235106 , 0017235107 , 0017235108 , 0017235109 , 0017235111 , 0017235112 , 0017235113 , 0017235114 , 0017235115 , 0017235116 , 0017235117 , 0017235118 , 0017235119 , 0017235120 , 0017235121 , 0017235123 , 0017235124 , 0017235125 , 0017235126 , 0017235127 , 0017235128 , 0017235129 , 0017235133 , 0017235134 , 0017235135 , 0017235136 , 0017235137 , 0017235138 , 0017235139 , 0017235140 , 0017235141 , 0017235142 , 0017235143 , 0017235144 , 0017235146 , 0017235149 , 0017235150 , 0017235151 , 0017235152 , 0017235153 , 0017235155 , 0017235156 , 0017235158 , 0"," 0017332542 , 0017332543 , 0017332544 , 0017332545 , 0017332546 , 0017332548 , 0017332549 , 0017332550 , 0017332551 , 0017332552 , 0017332553 , 0017332554 , 0017332555 , 0017332556 , 0017332557 , 0017332558 , 0017332560 , 0017332561 , 0017332562 , 0017332563 , 0017332565 , 0017332566 , 0017332567 , 0017332568 , 0017332569 , 0017332570 , 0017332571 , 0017332572 , 0017332573 , 0017332574 , 0017332575 , 0017332576 , 0017332577 , 0017332578 , 0017332579 , 0017332580 , 0017332581 , 0017332582 , 0017332583 , 0017332584 , 0017332585 , 0017332586 , 0017332587 , 0017332588 , 0017332589 , 0017332591 , 0017332592 , 0017332593 , 0017332594 , 0017332595 , 0017332597 , 0017332598 , 0017332599 , 0017332600 , 0017332601 , 0017332602 , 0017332603 , 0017332605 , 0017332607 , 0017332608 , 0017332609 , 0017332610 , 0017332611 , 0017332612 , 0017332613 , 0017332614 , 0017332615 , 0017332616 , 0017332617 , 0017332618 , 0017332619 , 0017332620 , 0017332621 , 0017332622 , 0017332623 , 0017332624 , 0017332626 , 0017332627 , 0017332629 , 0017332630 , 0017332631 , 0017332633 , 0017332634 , 0017332635 , 0017332636 , 0017332637 , 0017332638 , 0017332639 , 0017332640 , 0017332641 , 0017332642 , 0017332643 , 0017332644 , 0017332645 , 0017332646 , 0017332647 , 0017332648 , 0017332650 , 0017332651 , 0017332653 , 0017332654 , 0017332655 , 0017332656 , 0017332657 , 0017332658 , 0017332659 , 0017332660 , 0017332661 , 0017332662 , 0017332663 , 0017332664 , 0017332666 , 0017332667 , 0017332668 , 0017332669 , 0017332670 , 0017332671 , 0017332672 , 0017332673 , 0017332675 , 0017332676 , 0017333732 , 0017333733 , 0017333734 , 0017333735 , 0017333737 , 0017333739 , 0017333742 , 0017333743 , 0017333744 , 0017333745 , 0017333746 , 0017333747 , 0017333748 , 0017333749 , 0017333750 , 0017333751 , 0017333752 , 0017333753 , 0017333755 , 0017333757 , 0017333758 , 0017333759 , 0017333760 , 0017333762 , 0017333763 , 0017333764 , 0017333765 , 0017333766 , 0017333767 , 0017333771 , 0017333772 , 0017333773 , 0017333774 , 0017333775 , 0017333776 , 0017333777 , 001","2,791 units","The devices secondary audio signal fails to activate. ",2/4/2013,"02/04/2013",8/7/2013,"08/07/2013"
"Biologics",65611,"Terminated","LifeSource","Rosemont","IL","US","Voluntary: Firm Initiated","Telephone","Pennsylvania","B-2383-13","Class II","Red Blood Cells Leukocytes Reduced","W288613000541; ",".","1","Blood product, which was collected from a donor who traveled to a malarial endemic area, was distributed. ",5/28/2013,"05/28/2013",10/2/2013,"10/02/2013"
"Biologics",65612,"Terminated","Blood Center Hammond Laboratory (the)","Hammond","LA","US","Voluntary: Firm Initiated","Telephone","Louisiana","B-2357-13","Class III","Red Blood Cells Leukocytes Reduced","W067113050945; ",".","1","Blood product, labeled with an incorrect expiration date and product code, was distributed.",5/29/2013,"05/29/2013",10/2/2013,"10/02/2013"
"Biologics",65613,"Terminated","The Blood Center","New Orleans","LA","US","Voluntary: Firm Initiated","Telephone","Louisiana","B-2365-13","Class II","Red Blood Cells","W067113021623; ",".","1","Blood products, collected from a donor who was at risk for variant Creutzfeldt-Jakob disease (vCJD), were distributed.",5/15/2013,"05/15/2013",10/2/2013,"10/02/2013"
"Biologics",65613,"Terminated","The Blood Center","New Orleans","LA","US","Voluntary: Firm Initiated","Telephone","Louisiana","B-2366-13","Class II","Fresh Frozen Plasma","W067113021623; ",".","1","Blood products, collected from a donor who was at risk for variant Creutzfeldt-Jakob disease (vCJD), were distributed.",5/15/2013,"05/15/2013",10/2/2013,"10/02/2013"
"Biologics",65613,"Terminated","The Blood Center","New Orleans","LA","US","Voluntary: Firm Initiated","Telephone","Louisiana","B-2367-13","Class II","Platelets","W067113021623; ",".","1","Blood products, collected from a donor who was at risk for variant Creutzfeldt-Jakob disease (vCJD), were distributed.",5/15/2013,"05/15/2013",10/2/2013,"10/02/2013"
"Devices",65614,"Ongoing","Becton Dickinson & Co.","Sparks","MD","US","Voluntary: Firm Initiated","Letter","Worldwide distribution: US (nationwide) and countries of:Belgium, Canada, Columbia, Mexico, Singapore, and Taiwan.","Z-1799-2013","Class II","BD BBL Schaedler K-V Agar with 5% Sheep Blood, carton of 20 plates, catalog # 221555, labeled in part ***Becton, Dickinson and Company 7 Loveton Circle Sparks, MD 21152 USA 800-638-8663 www.bd.com/ds*** Vancomycin Screen Agar is used to test entercocci for resistance to vancomycin and to predict the synergistic activity of this antimicrobial with an aminoglycoside antimicrobial.","Lot 3078263 Exp 5/16/13",,"92 cartons","Microbiological identification media may exhibit reduced levels of Vancomycin.",6/6/2013,"06/06/2013",7/31/2013,"07/31/2013"
"Devices",65614,"Ongoing","Becton Dickinson & Co.","Sparks","MD","US","Voluntary: Firm Initiated","Letter","Worldwide distribution: US (nationwide) and countries of:Belgium, Canada, Columbia, Mexico, Singapore, and Taiwan.","Z-1798-2013","Class II","BD BBL Vancomycin Screen Agar, carton of 10 plates, catalog # 222204, labeled in part ***Becton, Dickinson and Company 7 Loveton Circle Sparks, MD 21152 USA 800-638-8663 www.bd.com/ds*** Vancomycin Screen Agar is used to test entercocci for resistance to vancomycin and to predict the synergistic activity of this antimicrobial with an aminoglycoside antimicrobial.","Lot 3081136 Exp June 18, 2013 Lot 3073114 Exp June 12, 2013 ",,"911 cartons","Microbiological identification media may exhibit reduced levels of Vancomycin.",6/6/2013,"06/06/2013",7/31/2013,"07/31/2013"
"Devices",65614,"Ongoing","Becton Dickinson & Co.","Sparks","MD","US","Voluntary: Firm Initiated","Letter","Worldwide distribution: US (nationwide) and countries of:Belgium, Canada, Columbia, Mexico, Singapore, and Taiwan.","Z-1804-2013","Class II","BD BBL BCYE Selective Agar with PAV, Catalog # 297880, packaged in cartons of 10 plates, and labeled in part ***Becton, Dickinson and Company 7 Loveton Circle Sparks, MD 21152 USA 800-638-8663 www.bd.com/ds*** BCYE Selective with PAV is used in qualitative procedures for isolation of Legionella species from clinical specimen and nonclinical (environmental) samples. It is similar to the Edelstein formula, except that the concentration of polymyxin B is reduced by half, and vancomycin is substituted for cefamandole.","Lot 3078348 Exp 6/27/13 ",,"163 cartons","Microbiological identification media may exhibit reduced levels of Vancomycin.",6/6/2013,"06/06/2013",7/31/2013,"07/31/2013"
"Devices",65614,"Ongoing","Becton Dickinson & Co.","Sparks","MD","US","Voluntary: Firm Initiated","Letter","Worldwide distribution: US (nationwide) and countries of:Belgium, Canada, Columbia, Mexico, Singapore, and Taiwan.","Z-1805-2013","Class II","BBL Campylobacter CSM Agar (Charcoal-Based Selective Medium), Catalog # 299614, packaged in cartons of 20 plates, and labeled in part ***Becton, Dickinson and Company 7 Loveton Circle Sparks, MD 21152 USA 800-638-8663 www.bd.com/ds*** BCYE Selective with PAV is used in qualitative procedures for isolation of Legionella species from clinical specimen and nonclinical (environmental) samples. It is similar to the Edelstein formula, except that the concentration of polymyxin B is reduced by half, and vancomycin is substituted for cefamandole.","Lot 3078430 Exp 5/30/13 ",,"293 cartons","Microbiological identification media may exhibit reduced levels of Vancomycin.",6/6/2013,"06/06/2013",7/31/2013,"07/31/2013"
"Devices",65614,"Ongoing","Becton Dickinson & Co.","Sparks","MD","US","Voluntary: Firm Initiated","Letter","Worldwide distribution: US (nationwide) and countries of:Belgium, Canada, Columbia, Mexico, Singapore, and Taiwan.","Z-1801-2013","Class II","BD BBL Anaerobe CNA Agar with 5% Sheep Blood // Anaerobe Laked Sheep Blood KV Agar, packaged in cartons of 20 plates, Catalog # 297041, and labeled in part ***Becton, Dickinson and Company 7 Loveton Circle Sparks, MD 21152 USA 800-638-8663 www.bd.com/ds*** Anaerobe Laked Sheep Blood KV Agar is used in a qualitative procedure for isolation of gram-negative anaerobic bacilli.","Lot 3080366 Exp 5/31/13 Lot 3071134 Exp 5/28/13 Lot 3081061 Exp 6/4/13",,"106 cartons","Microbiological identification media may exhibit reduced levels of Vancomycin.",6/6/2013,"06/06/2013",7/31/2013,"07/31/2013"
"Devices",65614,"Ongoing","Becton Dickinson & Co.","Sparks","MD","US","Voluntary: Firm Initiated","Letter","Worldwide distribution: US (nationwide) and countries of:Belgium, Canada, Columbia, Mexico, Singapore, and Taiwan.","Z-1803-2013","Class II","BBL Brucella Laked Blood Agar with Kanamycin and Vancomycin (KV), Catalog # 297840, packaged in cartons of 20 plates, labeled in part ***Becton, Dickinson and Company 7 Loveton Circle Sparks, MD 21152 USA 800-638-8663 www.bd.com/ds*** Brucella Laked Blood with KV is used for the selective isolation of fastidious and slow growing, obligately anaerobic bacteria from the same specimen. ","Lot 3078280 Exp 6/27/13 ",,"92 cartons","Microbiological identification media may exhibit reduced levels of Vancomycin.",6/6/2013,"06/06/2013",7/31/2013,"07/31/2013"
"Devices",65614,"Ongoing","Becton Dickinson & Co.","Sparks","MD","US","Voluntary: Firm Initiated","Letter","Worldwide distribution: US (nationwide) and countries of:Belgium, Canada, Columbia, Mexico, Singapore, and Taiwan.","Z-1800-2013","Class II","BD BBL CDC Anaerobe 5% Sheep Blood Agar with Kanamycin and Vancomycin (KV), packaged in cartons of 100 plates, Catalog # 221736, and labeled in part ***Becton, Dickinson and Company 7 Loveton Circle Sparks, MD 21152 USA 800-638-8663 www.bd.com/ds*** CDC Anaerobe 5% Sheep Blood Agar with Kanamycin and Vancomycin is used for the selective isolation of fastidious and slow-growing, obligately anaerobic gram-negative bacteria from a variety of clinical and nonclinical materials.","Lot 3080083 Exp 6/4/13 Lot 3073075 Exp 5/29/13",,"45 cartons","Microbiological identification media may exhibit reduced levels of Vancomycin.",6/6/2013,"06/06/2013",7/31/2013,"07/31/2013"
"Devices",65614,"Ongoing","Becton Dickinson & Co.","Sparks","MD","US","Voluntary: Firm Initiated","Letter","Worldwide distribution: US (nationwide) and countries of:Belgium, Canada, Columbia, Mexico, Singapore, and Taiwan.","Z-1802-2013","Class II","BD BBL BBE // CDC Anaerobe Laked Sheep Blood Agar with KV, packaged in cartons of 100 plates, Catalog # 297260, and labeled in part ***Becton, Dickinson and Company 7 Loveton Circle Sparks, MD 21152 USA 800-638-8663 www.bd.com/ds*** Bacteroides Bile Esculin Agar (BBE) is recommended as a primary isolation medium for the selection and presumptive identification of the B. fragilis group.","Lot 3071112 Exp 5/28/13 ",,"42 cartons","Microbiological identification media may exhibit reduced levels of Vancomycin.",6/6/2013,"06/06/2013",7/31/2013,"07/31/2013"
"Food",65615,"Ongoing","GKI Foods, LLC","Brighton","MI","US","Voluntary: Firm Initiated","Telephone","Traverse City, MI. One customer.","F-1642-2013","Class II","Shoreline Fruit Dark Chocolate Covered Dried Balaton Cherries Net Wt. 25 lbs Product of USA Traverse City, MI 49684 ","Lot 02513",".","259-25lb cases ","GKI is recalling Dark Chocolate Cherries produced on Jan 25, 2013 because dark chocolate strawberries are mixed with dark chocolate cherries. The strawberries contain sufites which are not declared on the label.",6/25/2013,"06/25/2013",7/17/2013,"07/17/2013"
"Drugs",65616,"Ongoing","Hospira Inc.","Lake Forest","IL","US","Voluntary: Firm Initiated","Letter","Nationwide","D-887-2013","Class II","Propofol Injectable Emulsion, 1%, 1 g/100 mL (10 mg/mL), 100 mL, Single patient infusion vial, RX only, Hospira, Inc., Lake Forest, IL 60045, NDC 0409-4699-24; Propofol Injectable Emulsion, 500 mg/50 mL, 50 mL, Single patient infusion vial, RX only, Hospira, Inc., Lake Forest, IL 60045, NDC 0409-4699-33","Lot 07-950-DJ Exp. Date 1JUL2013, 10-101-DJ Exp. Date 1OCT2013, and 10-102-DJ Exp. Date 1OCT2013",,"94,110 vials","Presence of Particulate Matter; single visible particulate was identified during a retain sample inspection identified as stainless steel",5/25/2013,"05/25/2013",8/21/2013,"08/21/2013"
"Devices",65617,"Ongoing","Nova Biomedical Corporation","Waltham","MA","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution - USA Nationwide and the countries of Chile, England , Peru, Nicaragua","Z-1897-2013","Class I","Nova Max Glucose Test Strips (50 Count Retail) Catalog Number: 43437 Product Usage: The Nova Max Glucose Test Strips are for use with the Nova Max Family of Glucose Monitors (Nova Max, Nova Max Plus, Nova Max Link, BD Logic and Paradigm Link). These monitors are intended to be used for the quantitative measurement of glucose in fresh capillary whole blood. They are intended for use by people with diabetes mellitus in the home and by healthcare professionals in clinical settings as an aid to monitor the effectiveness of diabetes control","Lot #/Exp.Date: 1010211346 12/31/2013 1020212032 02/28/2014 1020212100 04/30/2014 1020212101 04/30/2014 1020212153 06/30/2014 1020212207 07/31/2014 1020212291 10/31/2014 1020213074 03/31/2015 1020213109 04/30/2015 1020411347 12/31/2013 1020412255 09/30/2014 1020412341 12/31/2014 1020512087 03/31/2014 1020611348 12/31/2013 1020712206 07/31/2014 1020811350 12/31/2013 ",,"22,395,802 test strips","Reports of false abnormally high glucose readings from test strips",7/15/2013,"07/15/2013",8/21/2013,"08/21/2013"
"Devices",65617,"Ongoing","Nova Biomedical Corporation","Waltham","MA","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution - USA Nationwide and the countries of Chile, England , Peru, Nicaragua","Z-1898-2013","Class I","Nova Max Glucose Test Strips (50 Count DME) Catalog Number: 43523 Product Usage: The Nova Max Glucose Test Strips are for use with the Nova Max Family of Glucose Monitors (Nova Max, Nova Max Plus, Nova Max Link, BD Logic and Paradigm Link). These monitors are intended to be used for the quantitative measurement of glucose in fresh capillary whole blood. They are intended for use by people with diabetes mellitus in the home and by healthcare professionals in clinical settings as an aid to monitor the effectiveness of diabetes control","Lot #/Exp.Date: 1010312046 10/31/2013 1020212032 02/28/2014 1020212100 04/30/2014 1020212101 04/30/2014 1020212153 06/30/2014 1020212207 07/31/2014 1020212291 10/31/2014 1020213074 03/31/2015 1020213109 04/30/2015 1020412255 09/30/2014 1020412341 12/31/2014 1020512087 03/31/2014 1020712206 07/31/2014 1020811350 12/31/2013 1020912292 10/31/2014 ",,"32,452,700 test strips","Reports of false abnormally high glucose readings from test strips",7/15/2013,"07/15/2013",8/21/2013,"08/21/2013"
"Devices",65617,"Ongoing","Nova Biomedical Corporation","Waltham","MA","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution - USA Nationwide and the countries of Chile, England , Peru, Nicaragua","Z-1900-2013","Class I","Nova Max Glucose Test Strips (100 Count Retail Canada)Catalog Number: 43955 Product Usage: The Nova Max Glucose Test Strips are for use with the Nova Max Family of Glucose Monitors (Nova Max, Nova Max Plus, Nova Max Link, BD Logic and Paradigm Link). These monitors are intended to be used for the quantitative measurement of glucose in fresh capillary whole blood. They are intended for use by people with diabetes mellitus in the home and by healthcare professionals in clinical settings as an aid to monitor the effectiveness of diabetes control","Lot #/Exp.Date: 1020212032 02/28/2014 1020212100 04/30/2014 1020212153 06/30/2014 1020212207 07/31/2014 1020213074 03/31/2015 1020412341 12/31/2014 1020912292 10/31/2014 ",,"1,564,500 test strips","Reports of false abnormally high glucose readings from test strips",7/15/2013,"07/15/2013",8/21/2013,"08/21/2013"
"Devices",65617,"Ongoing","Nova Biomedical Corporation","Waltham","MA","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution - USA Nationwide and the countries of Chile, England , Peru, Nicaragua","Z-1904-2013","Class I","Nova Max Glucose Test Strips (10 Count Canada)Catalog Number: 43877 Product The Nova Max Glucose Test Strips are for use with the Nova Max Family of Glucose Monitors (Nova Max, Nova Max Plus, Nova Max Link, BD Logic and Paradigm Link). These monitors are intended to be used for the quantitative measurement of glucose in fresh capillary whole blood. They are intended for use by people with diabetes mellitus in the home and by healthcare professionals in clinical settings as an aid to monitor the effectiveness of diabetes control","1020211350 12/31/2013",,"9,200","Reports of false abnormally high glucose readings from test strips",7/15/2013,"07/15/2013",8/21/2013,"08/21/2013"
"Devices",65617,"Ongoing","Nova Biomedical Corporation","Waltham","MA","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution - USA Nationwide and the countries of Chile, England , Peru, Nicaragua","Z-1901-2013","Class I","Nova Max Glucose Test Strips (10 Count Vials) Catalog Number: 43604 These strips are kitted into Nova Max Glucose Test Strip System Kits 43435 and 45507 Product Usage: The Nova Max Glucose Test Strips are for use with the Nova Max Family of Glucose Monitors (Nova Max, Nova Max Plus, Nova Max Link, BD Logic and Paradigm Link). These monitors are intended to be used for the quantitative measurement of glucose in fresh capillary whole blood. They are intended for use by people with diabetes mellitus in the home and by healthcare professionals in clinical settings as an aid to monitor the effectiveness of diabetes control","Lot #/Exp.Date: 1020212032 02/28/2014 1020212153 06/30/2014 1020212207 07/31/2014 1020212291 10/31/2014 1020213074 03/31/2015 1020213109 04/30/2015 1020412255 09/30/2014 1020412341 12/31/2014 1020512087 03/31/2014 1020811350 12/31/2013 102121304 02/28/2015 ",,"*Kitted into System Kits 43435 and 45507","Reports of false abnormally high glucose readings from test strips",7/15/2013,"07/15/2013",8/21/2013,"08/21/2013"
"Devices",65617,"Ongoing","Nova Biomedical Corporation","Waltham","MA","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution - USA Nationwide and the countries of Chile, England , Peru, Nicaragua","Z-1905-2013","Class I","Nova Max Plus Monitor System (Kit w/10 Count Vials Canada) Catalog Number: 43861 Product usage: The Nova Max Glucose Test Strips are for use with the Nova Max Family of Glucose Monitors (Nova Max, Nova Max Plus, Nova Max Link, BD Logic and Paradigm Link). These monitors are intended to be used for the quantitative measurement of glucose in fresh capillary whole blood. They are intended for use by people with diabetes mellitus in the home and by healthcare professionals in clinical settings as an aid to monitor the effectiveness of diabetes control","1010112073 10/31/2013 1010113002 03/31/2014 1010113008 03/31/2014 1010312097* 10/31/2013 1010512080** 10/31/2013 ",,"28,240 kits","Reports of false abnormally high glucose readings from test strips",7/15/2013,"07/15/2013",8/21/2013,"08/21/2013"
"Devices",65617,"Ongoing","Nova Biomedical Corporation","Waltham","MA","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution - USA Nationwide and the countries of Chile, England , Peru, Nicaragua","Z-1899-2013","Class I","Nova Max Glucose Test Strips (10 Count Boxed) Catalog Number: 43590 Product Usage: The Nova Max Glucose Test Strips are for use with the Nova Max Family of Glucose Monitors (Nova Max, Nova Max Plus, Nova Max Link, BD Logic and Paradigm Link). These monitors are intended to be used for the quantitative measurement of glucose in fresh capillary whole blood. They are intended for use by people with diabetes mellitus in the home and by healthcare professionals in clinical settings as an aid to monitor the effectiveness of diabetes control","Lot #/Exp.Date: 1020211355 12/31/2013 1020212032 02/28/2014 1020212207 07/31/2014 1020212291 10/31/2014 1020213043 02/28/2015 1020213109 04/30/2015 1020412255 09/30/2014 1020412341 12/31/2014 1020512087 03/31/2014 1020811350 12/31/2013 ",,"721,810 test strips","Reports of false abnormally high glucose readings from test strips",7/15/2013,"07/15/2013",8/21/2013,"08/21/2013"
"Devices",65617,"Ongoing","Nova Biomedical Corporation","Waltham","MA","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution - USA Nationwide and the countries of Chile, England , Peru, Nicaragua","Z-1902-2013","Class I","Nova Max Glucose Test Strips (50 Count International Catalog Number: 45512 Product usage: The Nova Max Glucose Test Strips are for use with the Nova Max Family of Glucose Monitors (Nova Max, Nova Max Plus, Nova Max Link, BD Logic and Paradigm Link). These monitors are intended to be used for the quantitative measurement of glucose in fresh capillary whole blood. They are intended for use by people with diabetes mellitus in the home and by healthcare professionals in clinical settings as an aid to monitor the effectiveness of diabetes control","Lot #/Exp.Date: 1020112086 03/31/2014 1020212032 02/28/2014 1020213074 03/31/2015 1020213109 04/30/2015 ",,"366,140 test strips","Reports of false abnormally high glucose readings from test strips",7/15/2013,"07/15/2013",8/21/2013,"08/21/2013"
"Devices",65617,"Ongoing","Nova Biomedical Corporation","Waltham","MA","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution - USA Nationwide and the countries of Chile, England , Peru, Nicaragua","Z-1906-2013","Class I","Nova Max Plus Monitor System (Kit w/10 Count Vials International) Catalog Number: 45507 Product Usage: The Nova Max Glucose Test Strips are for use with the Nova Max Family of Glucose Monitors (Nova Max, Nova Max Plus, Nova Max Link, BD Logic and Paradigm Link). These monitors are intended to be used for the quantitative measurement of glucose in fresh capillary whole blood. They are intended for use by people with diabetes mellitus in the home and by healthcare professionals in clinical settings as an aid to monitor the effectiveness of diabetes control","1010112059 12/31/2013 1010213171 04/30/2015 1010312066 12/31/2013 1010712339 10/31/2014 ",,"13,600 kits","Reports of false abnormally high glucose readings from test strips",7/15/2013,"07/15/2013",8/21/2013,"08/21/2013"
"Devices",65617,"Ongoing","Nova Biomedical Corporation","Waltham","MA","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution - USA Nationwide and the countries of Chile, England , Peru, Nicaragua","Z-1903-2013","Class I","Nova Max Plus Monitor System (Kit w/10 Count Vials) Catalog Number: 43435 Product usage: The Nova Max Glucose Test Strips are for use with the Nova Max Family of Glucose Monitors (Nova Max, Nova Max Plus, Nova Max Link, BD Logic and Paradigm Link). These monitors are intended to be used for the quantitative measurement of glucose in fresh capillary whole blood. They are intended for use by people with diabetes mellitus in the home and by healthcare professionals in clinical settings as an aid to monitor the effectiveness of diabetes control","Kit Lot/Exp: 1010112004 10/31/2013 1010112038 10/31/2013 1010112109 02/28/2014 1010112121 02/28/2014 1010112159 02/28/2014 1010112228 05/31/2014 1010112289 07/31/2014 1010113016 09/30/2014 1010113052 12/31/2014 1010113134 12/31/2014 1010113177 03/31/2015 1010212046 10/31/2013 1010212109 02/28/2014 1010212121 12/31/2013 1010212143 02/28/2014 1010212206 03/31/2014 1010212228 03/31/2014 1010212289 07/31/2014 1010212354 09/30/2014 1010213016 09/30/2014 1010213052 12/31/2014 1010213134 09/30/2014 1010312016 10/31/2013 1010312025 10/31/2013 1010312046 10/31/2013 1010312095 02/28/2014 1010312121 03/31/2014 1010312171 03/31/2014 1010312180 03/31/2014 1010312207 03/31/2014 1010312228 05/31/2014 1010312262 06/30/2014 1010312289 07/31/2014 1010312312 09/30/2014 1010312354 09/30/2014 1010313016 09/30/2014 1010313052 12/31/2014 1010313101 12/31/2014 1010313128 01/31/2015 1010313134 01/31/2015 1010411355 10/31/2013 1010412016 10/31/2013 1010412046 10/31/2013 1010412066 10/31/2013 1010412093 12/31/2013 1010412095 10/31/2013 1010412121 03/31/2014 1010412262 03/31/2014 1010412312 09/30/2014 1010413101 01/31/2015 1010413134 01/31/2015 1010413171 04/30/2015 1010512016 10/31/2013 1010512095 12/31/2013 1010512157 03/31/2014 1010512212 03/31/2014 1010512262 07/31/2014 1010512269 07/31/2014 1010512312 09/30/2014 1010513085 12/31/2014 1010513101 01/31/2015 1010513171 04/30/2015 1010612095 02/28/2014 1010612157 03/31/2014 1010612262 07/31/2014 1010612312 07/31/2014 1010612339 09/30/2014 1010613085 10/31/2014 1010613171 04/30/2015 1010712157 03/31/2014 1010712262 07/31/2014 1010713079 12/31/2014 1010713085 12/31/2014 1010813085 12/31/2014 1010912254 05/31/2014 1011113007 09/30/2014 ",,"1,316,420 kits","Reports of false abnormally high glucose readings from test strips",7/15/2013,"07/15/2013",8/21/2013,"08/21/2013"
"Food",65618,"Ongoing","Shoreline Fruit Inc","Traverse City","MI","US","Voluntary: Firm Initiated","Telephone","US: MI, SC, CA, NY, and OK. International: Hong Kong","F-1799-2013","Class II","Cherry Bay Orchards Dark Chocolate Covered Dried Balaton Cherries 4lb, 8oz, and 16oz containers","4 lbs. 8-53955-00004-1 with lot codes: 042314, 060514, and 040914. 8 oz. 8-46659-00007-3 with lot codes: 032714, 042314, 052314, 052914, and 062014. 16 oz. 8-46659-00008-0 with lot codes: 051414 and 040814. ",,"230 cases (1150.7lbs)","The firm was notified by their immediate supplier GKI, Inc that the Dark Chocolate Covered Dried Cherries contained some Dark Chocolate Strawberries. The strawberries contain sulfites which are not declared on the label. Shoreline Fruit, LLC has initiated a voluntary product recall of its Dark Chocolate Covered Dried Balaton Cherries because of a possible cross contamination with undeclared dark chocolate covered dried strawberries.",6/25/2013,"06/25/2013",8/21/2013,"08/21/2013"
"Food",65618,"Ongoing","Shoreline Fruit Inc","Traverse City","MI","US","Voluntary: Firm Initiated","Telephone","US: MI, SC, CA, NY, and OK. International: Hong Kong","F-1797-2013","Class II","Spartan Fresh Dark Chocolate Covered Dried Cherries 8oz","Distributed 6/26/13: UPC code: 0-11213-01592 and lot codes: 021814, 031214, 032714, and 061214.",,"165 (990lbs)","The firm was notified by their immediate supplier GKI, Inc that the Dark Chocolate Covered Dried Cherries contained some Dark Chocolate Strawberries. The strawberries contain sulfites which are not declared on the label. Shoreline Fruit, LLC has initiated a voluntary product recall of its Dark Chocolate Covered Dried Balaton Cherries because of a possible cross contamination with undeclared dark chocolate covered dried strawberries.",6/25/2013,"06/25/2013",8/21/2013,"08/21/2013"
"Food",65618,"Ongoing","Shoreline Fruit Inc","Traverse City","MI","US","Voluntary: Firm Initiated","Telephone","US: MI, SC, CA, NY, and OK. International: Hong Kong","F1798-2013","Class II","Shoreline Fruit Dark Chocolate Covered Dried Balaton Cherries 25lbs","Lot code: 012513 ",,"70.2 (1680lbs)","The firm was notified by their immediate supplier GKI, Inc that the Dark Chocolate Covered Dried Cherries contained some Dark Chocolate Strawberries. The strawberries contain sulfites which are not declared on the label. Shoreline Fruit, LLC has initiated a voluntary product recall of its Dark Chocolate Covered Dried Balaton Cherries because of a possible cross contamination with undeclared dark chocolate covered dried strawberries.",6/25/2013,"06/25/2013",8/21/2013,"08/21/2013"
"Devices",65619,"Ongoing","Becton Dickinson & Co.","Sparks","MD","US","Voluntary: Firm Initiated","Letter","Nationwide Distribution","Z-1812-2013","Class II","BD Affirm VPIII Microbial Identification Tests, packaged in kits, 120 test\kit, Catalog # 446257 and 24 test\kit, Catalog # 446252; kits are labeled in part ***Becton, Dickinson and Company, 7 Loveton Circle Sparks, MD 21152 USA, 800-638-8663, www.bd.com/ds*** The Affirm VPIII Microbial Identification Test is a DNA probe test intended for use in the detection and identification of Candida species,","Cat #446257: Lot 3035126 Exp 12/04/13 Cat #446252: Lot 3065261 Exp 08/31/13 ",,"177 kits","In vitro diagnostic test kit may exhibit invalid internal negative control results.",6/13/2013,"06/13/2013",8/7/2013,"08/07/2013"
"Devices",65620,"Ongoing","Siemens Medical Solutions USA, Inc","Malvern","PA","US","Voluntary: Firm Initiated","Letter","United States Nationwide Distribution - including the states of: CA, CO, FL, IA, IL, IN, MA, MD, MI, NC, NY, PA, TX, VA and WA and Puerto Rico.","Z-1750-2013","Class II","Siemens AXIOM Artis zee/zeego systems equipped with generator A100 Plus Product Usage: Angiographic x-ray system ","Material number 10094137 -- serial numbers 147515, 147500, 147528, 147514, 147516, 147526; material number 10094141 -- serial numbers 154408, 154406, 154453, 154423, 154430, 154425, 154429; material number 10280959 -- serial numbers 160813, 160823, 160812, 160800, 160431, 160814, 160807, 160817, 160816; material number 10094139 -- serial number 157907.",".","23","During the course of product monitoring, Siemens became aware of a tolerance problem in the power supply of the generator control above a specific value, thus, the generator may fail.",1/31/2013,"01/31/2013",7/24/2013,"07/24/2013"
"Drugs",65621,"Ongoing","Oklahoma Respiratory Care Inc","Norman","OK","US","Voluntary: Firm Initiated","Visit","Oklahoma","D-818-2013","Class II","Oxygen, Compressed USP UN1072 Medical Gas supplied in a) 682 litres and b)165 litres cylinders, Rx only, Oklahoma Respiratory Care 800.262.9857, Norman, OK 73071","Lot numbers: 03141201, 03211201, 05021201, 06271201, and 11081201.",,"94 cylinders","Failed impurities/degradation specifications: Purity readings for oxygen were out of specification.",12/5/2012,"12/05/2012",7/31/2013,"07/31/2013"
"Devices",65622,"Ongoing","Philips Healthcare Inc.","Andover","MA","US","Voluntary: Firm Initiated","Letter","USA Nationwide Distribution","Z-1780-2013","Class II","Radiohead Access Point 1.4 GHz Radiohead Access Point Firmware versions: C.00.04 & C.00.05 Part Number: 989803171211 Product Usage: IntelliVue Smart-hopping 1.4 GHz Access Point provides wireless connectivity between IntelliVue devices (listed below) and the Philips IntelliVue Information Center. MX40 Indicated for use by health care professionals whenever there is a need for monitoring the physiological parameters of patients. Intended for monitoring and recording of, and to generate alarms for, multiple physiological parameters of adults and pediatrics in hospital environments and during transport inside hospitals. The MX4O is to be used primarily as a traditional telemetry medical device. It connects to the IntelliVue Information Center by way of a wireless network.","Serial numbers ranging from: US12700465 to US20823366",,"20105 units","IntelliVue Smart-hopping 1.4 GHz Access Point may experience unexpected signal loss of several minutes impacting wireless connectivity",7/8/2013,"07/08/2013",7/31/2013,"07/31/2013"
"Biologics",65623,"Terminated","Blood Centers of the Pacific - Irwin Center","San Francisco","CA","US","Voluntary: Firm Initiated","FAX","Austria; California","B-2368-13","Class II","Red Blood Cells Leukocytes Reduced","W117008118113; ",".","1","Blood products, collected from a donor who was at risk for variant Creutzfeldt-Jakob Disease (vCJD), were distributed.",3/27/2013,"03/27/2013",10/2/2013,"10/02/2013"
"Biologics",65623,"Terminated","Blood Centers of the Pacific - Irwin Center","San Francisco","CA","US","Voluntary: Firm Initiated","FAX","Austria; California","B-2369-13","Class II","Blood and Blood Products for Reprocessing","W117008118113; ",".","1","Blood products, collected from a donor who was at risk for variant Creutzfeldt-Jakob Disease (vCJD), were distributed.",3/27/2013,"03/27/2013",10/2/2013,"10/02/2013"
"Biologics",65624,"Terminated","OneBlood, Inc.","Hialeah","FL","US","Voluntary: Firm Initiated","Telephone","Switzerland; Florida; New York","B-2374-13","Class II","Red Blood Cells","2642211; W036808137145; W036809172740; W036810117211; ",".","4","Blood products, which were collected from a donor in which donor suitability was not adequately determined, were distributed.",6/7/2013,"06/07/2013",10/2/2013,"10/02/2013"
"Biologics",65624,"Terminated","OneBlood, Inc.","Hialeah","FL","US","Voluntary: Firm Initiated","Telephone","Switzerland; Florida; New York","B-2376-13","Class II","Fresh Frozen Plasma","W036809154710; W036810117211; ",".","2","Blood products, which were collected from a donor in which donor suitability was not adequately determined, were distributed.",6/7/2013,"06/07/2013",10/2/2013,"10/02/2013"
"Biologics",65624,"Terminated","OneBlood, Inc.","Hialeah","FL","US","Voluntary: Firm Initiated","Telephone","Switzerland; Florida; New York","B-2370-13","Class II","Cryoprecipitated AHF","2642211; W036808137145; W036809172740; ",".","3","Blood products, which were collected from a donor in which donor suitability was not adequately determined, were distributed.",6/7/2013,"06/07/2013",10/2/2013,"10/02/2013"
"Biologics",65624,"Terminated","OneBlood, Inc.","Hialeah","FL","US","Voluntary: Firm Initiated","Telephone","Switzerland; Florida; New York","B-2373-13","Class II","Red Blood Cells Leukocytes Reduced","W036809154256; W036809154710; ",".","2","Blood products, which were collected from a donor in which donor suitability was not adequately determined, were distributed.",6/7/2013,"06/07/2013",10/2/2013,"10/02/2013"
"Biologics",65624,"Terminated","OneBlood, Inc.","Hialeah","FL","US","Voluntary: Firm Initiated","Telephone","Switzerland; Florida; New York","B-2375-13","Class II","Platelets Pooled Leukocytes Reduced","W036809819555; W036810813443; ",".","2","Blood products, which were collected from a donor in which donor suitability was not adequately determined, were distributed.",6/7/2013,"06/07/2013",10/2/2013,"10/02/2013"
"Biologics",65624,"Terminated","OneBlood, Inc.","Hialeah","FL","US","Voluntary: Firm Initiated","Telephone","Switzerland; Florida; New York","B-2371-13","Class II","Platelets Leukocytes Reduced","W036809154256; ",".","1","Blood products, which were collected from a donor in which donor suitability was not adequately determined, were distributed.",6/7/2013,"06/07/2013",10/2/2013,"10/02/2013"
"Biologics",65624,"Terminated","OneBlood, Inc.","Hialeah","FL","US","Voluntary: Firm Initiated","Telephone","Switzerland; Florida; New York","B-2372-13","Class III","Blood and Blood Products for Reprocessing","W036808137145; W036809172740; W036809154256; ",".","3","Blood products, which were collected from a donor in which donor suitability was not adequately determined, were distributed.",6/7/2013,"06/07/2013",10/2/2013,"10/02/2013"
"Biologics",65625,"Terminated","LifeShare Blood Centers","Beaumont","TX","US","Voluntary: Firm Initiated","FAX","Texas","B-2377-13","Class II","Red Blood Cells Leukocytes Reduced","W036513027187; ",".","1","Blood products, collected from donors, whose suitability to donate was not adequately determined, were distributed.",5/28/2013,"05/28/2013",10/2/2013,"10/02/2013"
"Biologics",65625,"Terminated","LifeShare Blood Centers","Beaumont","TX","US","Voluntary: Firm Initiated","FAX","Texas","B-2378-13","Class II","Fresh Frozen Plasma","W036513027187; ",".","1","Blood products, collected from donors, whose suitability to donate was not adequately determined, were distributed.",5/28/2013,"05/28/2013",10/2/2013,"10/02/2013"
"Devices",65626,"Ongoing","Siemens Healthcare Diagnostics, Inc","East Walpole","MA","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution-Nationwide including PR and the states of AL, AR, AZ, CA, CO, CT, FL, GA, IA, IL, IN, KS, KY, LA, MA, MD, MI, MN, MO, NC, NJ, NV, NY, OH, PA, TN, TX, VA, VT, and WV and the countries of Slovakia, Germany, Turkey, TW, HK, CH, TH, BR, CN, SG, and ZA.","Z-1970-2013","Class III","ADVIA Centaur Calibrator A. Cat. #04800735, SMN 10285904 (6 pack); Cat. # 04800840, SMN 10285905 (6 pack - REF). For calibrating the following assays using the ADVIA Centaur or ACS:180 systems: FT3, T3, T4, Tup, FT4, THEO2. ","REF 10285904 (6 pack): 89983A77 16 Jul 2013, 90669A77 16 Jul 2013; REF 10285905 (6 pack - REF); 90705A77 16 Jul 2013 ",,"265 Cal A 6 packs (US and OUS)","Calibrator A lot CA77 is under-recovering to the assigned target for the ADVIA Centaur Total T4 Assay. ",6/28/2013,"06/28/2013",8/21/2013,"08/21/2013"
"Food",65627,"Ongoing","Somersault Snack Co., LLC","Sausalito","CA","US","Voluntary: Firm Initiated","Telephone","Distribution centers in CA, OH, GA, KS and SC and then on to stores in AZ, FL, HI, MO, NC,NE, NV, NY, OK, PA, TX and WV.","F-1715-2013","Class I","Somersault Pacific Sea Salt flavor, crunchy nuggets baked with sunflower seeds and toasted grains. 1 oz. packages sold in 6-count multi packs. Somersault Snacks co., LLC; Sausalito, Ca 94965","BOX UPC: 0 898403 00221 5 (located on the bottom of the box); PACKAGE UPC: 0 898403 00220 8 (located on the rear panel of each package;) SELL BY DATES: FEB061483 and FEB061481. ",".","712 cases. Each case contains 6 boxes of 6-count multi packs.","A limited number of packages of 1 ounce Somersault Pacific Sea Salt products were inadvertently mispackaged - Somersault Santa Fe Salsa flavored product were inadvertently commingled with Somersault Pacific Sea Salt flavored product in packages labeled as Somersault Pacific Sea Salt.",7/2/2013,"07/02/2013",7/24/2013,"07/24/2013"
"Food",65628,"Ongoing","Los Milagros Tortilleria, LLC","Tucson","AZ","US","Voluntary: Firm Initiated","Telephone","AZ","F-1619-2013","Class II","Milagros Green Corn Tamales, packaged in plastic in quantities of one dozen","No lot/production codes on the products",".","95 units","Los Milagros Tortilleria is recalling Milagros Tortillas Green Corn Tamales because they did not list the sub-ingredient for Monterey Jack Cheese which contains the milk allergen.",6/28/2013,"06/28/2013",7/17/2013,"07/17/2013"
"Drugs",65629,"Ongoing","Max Huber Research Labs, Inc.","New York","NY","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Nationwide","D-816-2013","Class III","LA MER the spf 18 fluid tint , broad spectrum spf 18, 1.7 fl.oz. liq./50 ml, Shade DARK 04, UPC 7 47930 00483 7 --- MAX HUBER RESEARCH LABS INC., DIST. NEW YORK, N.Y. 10022 -- MADE IN BELGIUM","all lots currently in the market shipped before June 2013",,"49,845 tubes (total for all products)","Subpotent drug: Avobenzone 3%, one of the active sunscreen ingredients may be subpotent and sunscreen effectiveness may be less than labeled",6/27/2013,"06/27/2013",7/31/2013,"07/31/2013"
"Drugs",65629,"Ongoing","Max Huber Research Labs, Inc.","New York","NY","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Nationwide","D-814-2013","Class III","LA MER the spf 18 fluid tint , broad spectrum spf 18, 1.7 fl.oz. liq./50 ml, Shade LIGHT 02, UPC 7 47930 00481 3, MAX HUBER RESEARCH LABS INC., DIST. NEW YORK, N.Y. 10022 -- MADE IN BELGIUM","all lots currently in the market shipped before June 2013",,"49,845 tubes (total for all products)","Subpotent Drug: Avobenzone 3%, one of the active sunscreen ingredients may be subpotent and sunscreen effectiveness may be less than labeled",6/27/2013,"06/27/2013",7/31/2013,"07/31/2013"
"Drugs",65629,"Ongoing","Max Huber Research Labs, Inc.","New York","NY","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Nationwide","D-815-2013","Class III","LA MER the spf 18 fluid tint , broad spectrum spf 18, 1.7 fl.oz. liq./50 ml, Shade MEDIUM 03, UPC 7 47930 00482 0 --- MAX HUBER RESEARCH LABS INC., DIST. NEW YORK, N.Y. 10022 -- MADE IN BELGIUM","all lots currently in the market shipped before June 2013",,"49,845 tubes (total for all products)","Subpotent Drug: Avobenzone 3%, one of the active sunscreen ingredients may be subpotent and sunscreen effectiveness may be less than labeled",6/27/2013,"06/27/2013",7/31/2013,"07/31/2013"
"Devices",65630,"Ongoing","Del Mar Reynolds Medical, Ltd.","Hertford",,"GB","Voluntary: Firm Initiated","Letter","Worldwide Distribution - USA including South Carolina and internationally to Canada and Great Britian.","Z-1771-2013","Class II","Spacelabs ARKON Anesthesia Workstation. Spacelabs ARKON Anesthesia Workstation may be used for the delivery of oxygen, air and nitrous oxide in a controlled manner to various patient breathing circuits with or without the use of mechanical ventilator, and may be used for the delivery of anesthetic vapor by use of a dismountable vaporizer. ","ARKN-000001, ARKN-000005, ARKN-000010, ARKN-000015, ARKN-000016, ARKN-000017, ARKN-000018, ARKN-000020, ARKN-000021. ",,"9 units (4 in the US and 5 outside US)","Spacelabs ARKON Anesthesia System is recalled due to software defect. The System Status Computer may incorrectly determine that a communication error has occurred. If this situation occurs, a buzzer will activate and a yellow triangle will be displayed on the System Status Computer screen that alerts the user of this error.",6/7/2013,"06/07/2013",7/31/2013,"07/31/2013"
"Devices",65631,"Ongoing","Synthes USA HQ, Inc.","West Chester","PA","US","Voluntary: Firm Initiated","Letter","Nationwide distribution.","Z-2058-2013","Class II","Synthes Trauma Nail System. The devices are indication for bone fixation.","Trauma Ex Nails, all lot numbers up to and including lot # 7072305 and Trochanteric Fixation Nails, all lot numbers up to and including lot # 7060897",,"1,011,783","Recall was initiated due to the possibility that the outer pouch was compromised. The product is packaged in two pouches; a sterile, internal pouch within an external pouch. It is the outer, external pouch that may be compromised. ",11/2/2012,"11/02/2012",9/4/2013,"09/04/2013"
"Biologics",65633,"Terminated","Midsouth Eye Bank for Sight Restoration Inc","Memphis","TN","US","Voluntary: Firm Initiated","Telephone","Venezuela","B-2274-13","Class II","Cornea","130051100; 130051200",,"2 allografts ","Human corneas, recovered from a donor whose donor eligibility determination failed to ensure that the donor was free from risk factors for, and clinical evidence of infection due to relevant communicable disease agents and diseases, were distributed. ",6/21/2013,"06/21/2013",9/25/2013,"09/25/2013"
"Biologics",65634,"Terminated","RTI Biologics, Inc.","Alachua","FL","US","Voluntary: Firm Initiated","Telephone","Tennessee; Ohio; Colorado; Indiana; New York; Texas","B-2411-13","Class III","Tendon","Donor ID: 101082885; Serial Numbers: 8519769, 8519770, 8519771, 8519772, 8519773, 8519776, 8519777 ",,"7 allografts","Human tissue allografts, recovered from a donor whose donor eligibility determination failed to ensure that the donor was free from risk factors for, and clinical evidence of infection due to relevant communicable disease agents and diseases, were distributed. ",6/17/2013,"06/17/2013",9/25/2013,"09/25/2013"
"Biologics",65634,"Terminated","RTI Biologics, Inc.","Alachua","FL","US","Voluntary: Firm Initiated","Telephone","Tennessee; Ohio; Colorado; Indiana; New York; Texas","B-2412-13","Class III","Bone","Donor ID 101082885; Serial Numbers: 7838730, 7838732, 7838733, 7838734, 7838735, 7838736, 7838737, 7838738, 7838739, 7838740, 7838741, 7838742, 7838743, 7838744, 7838745, 7838746, 7838747, 7915488, 7915489, 7915490, 7915491, 7915492, 7915493, 7915494, 7915495, 7915496, 7915497, 7931192, 7931193 ",,"29 allografts","Human tissue allografts, recovered from a donor whose donor eligibility determination failed to ensure that the donor was free from risk factors for, and clinical evidence of infection due to relevant communicable disease agents and diseases, were distributed. ",6/17/2013,"06/17/2013",9/25/2013,"09/25/2013"
"Devices",65635,"Ongoing","Haemonetics Corporation","Braintree","MA","US","Voluntary: Firm Initiated","Letter","US Nationwide","Z-1796-2013","Class II","TEG 5000 Thromboelastograph Coagulation Analyzer Product Usage: Multipurpose System for In Vitro Coagulation Studies ","Per recall strategy. ",,"1590 devices","Research Use Only (RUO) parameters were included in TEG 5000 User Manual. ",6/20/2013,"06/20/2013",7/31/2013,"07/31/2013"
"Biologics",65636,"Terminated","Knoxville Plasma Corporation","Knoxville","TN","US","Voluntary: Firm Initiated","E-Mail","Tennessee; California","B-2379-13","Class II","Source Plasma","TQ215673; TQ213787; ",".","2","Blood products, collected from a donor who received a tattoo within 12 months of donation, were distributed.",5/7/2013,"05/07/2013",10/2/2013,"10/02/2013"
"Biologics",65637,"Terminated","RTI Biologics, Inc.","Alachua","FL","US","Voluntary: Firm Initiated","Telephone","Tennessee; Oklahoma; Korea, Republic Of(South); Alabama; Louisiana; Florida; Indiana; Texas","B-2414-13","Class III","Bone","Donor ID - 101084060; Serial Numbers: 7841388, 7841389, 7841390, 7841391, 7841392, 7841393, 7841394, 7841395, 7841396, 7841397, 7841398, 7841399, 7843050, 7843051, 7843052, 7843053, 7843056, 7843057, 7843058, 7843059, 7843060, 7843061, 7843062, 7843063, 7843064, 7843065, 7843066, 7843067, 7844245, 7844246, 7844247, 7844248, 7844249, 7844250, 7844251, 7844252, 7844253, 7844254, 7844255, 7844256, 7844257, 7844258, 7844259, 7844260, 7844261, 7844266, 7844267",,"47 allografts ","Human tissue allografts, recovered from a donor whose donor eligibility determination failed to ensure that the donor was free from risk factors for, and clinical evidence of infection due to relevant communicable disease agents and diseases, were distributed. ",6/17/2013,"06/17/2013",9/25/2013,"09/25/2013"
"Biologics",65637,"Terminated","RTI Biologics, Inc.","Alachua","FL","US","Voluntary: Firm Initiated","Telephone","Tennessee; Oklahoma; Korea, Republic Of(South); Alabama; Louisiana; Florida; Indiana; Texas","B-2413-13","Class III","Tendon","Donor ID 101084060; Serial Numbers: 8464116, 8464117, 8464118, 8464120, 8464121, 8464122",,"6 allografts","Human tissue allografts, recovered from a donor whose donor eligibility determination failed to ensure that the donor was free from risk factors for, and clinical evidence of infection due to relevant communicable disease agents and diseases, were distributed. ",6/17/2013,"06/17/2013",9/25/2013,"09/25/2013"
"Biologics",65638,"Terminated","Community Blood Bank of Erie County","Erie","PA","US","Voluntary: Firm Initiated","Letter","Pennsylvania","B-2380-13","Class II","Red Blood Cells","W045613002185; ",".","1","Blood product, which was collected from a donor who traveled to a malarial endemic area, was distributed.",5/26/2013,"05/26/2013",10/2/2013,"10/02/2013"
"Biologics",65639,"Terminated","American Red Cross Blood Services Heart of America Region","Peoria","IL","US","Voluntary: Firm Initiated","Telephone","Illinois","B-2382-13","Class II","Platelets Pheresis Leukocytes Reduced Irradiated","W204013801543; ",".","1","Blood products, which did not meet the acceptable product specifications, were distributed.",4/1/2013,"04/01/2013",10/2/2013,"10/02/2013"
"Biologics",65639,"Terminated","American Red Cross Blood Services Heart of America Region","Peoria","IL","US","Voluntary: Firm Initiated","Telephone","Illinois","B-2381-13","Class II","Platelets Pheresis Leukocytes Reduced","W204013801547A; W204013801547B; W204013801539; W204013801551A; W204013801551B; W204013801551C; ",".","6","Blood products, which did not meet the acceptable product specifications, were distributed.",4/1/2013,"04/01/2013",10/2/2013,"10/02/2013"
"Food",65640,"Ongoing","NOW Foods","Bloomingdale","IL","US","Voluntary: Firm Initiated","Letter","US: Nationwide; Foreign: United Kingdom","F-1726-2013","Class II","White plastic bottle with blue cap containing 90 capsules; Ashwagandha Extract; 450 mg; CODE 4603; Manufactured by NOW FOODS; 395 S. Glen Ellyn Rd., Bloomingdale, IL 60108, USA","UPC: 7 33739 04603 1; Product Code: 4603; Lot: 1599135; Best By: May 2015",,"2,571 bottles","It has been determined that this product contains an undeclared ingredient, licorice extract, which contains glycyrrhizin derived from licorice root.",7/3/2013,"07/03/2013",7/31/2013,"07/31/2013"
"Veterinary",65641,"Ongoing","Hubbard Feeds, Inc.","Shipshewana","IN","US","Voluntary: Firm Initiated","Letter","Michigan and Indiana","V-037-2014","Class I","Hubbard Life Homestead FASTGROW AM.0.0125 NAB/NAB MEDICATED Complete Chicken Starter/ Grower/ Finisher/ Broiler Feed, Complete Turkey Grower/ Finisher Aid in prevention of coccidiosis. ACTIVE DRUG INGREDIENT AMPROLIUM 0.0125 % ","Item No.: 34739-2 and Lot Number: B00570987",".","101/ 50lb bags","Hubbard Feeds Inc. announced today a voluntary recall in Indiana and Michigan Due to Potentially Elevated Calcium and Phosphorus in one lot of Hubbard Life Homestead FASTGROW AM.0125 NAP/NAB MEDICATED which may be harmful to chickens and turkeys.",7/2/2013,"07/02/2013",12/26/2013,"12/26/2013"
"Drugs",65642,"Ongoing","Church & Dwight Inc","Princeton","NJ","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Nationwide","D-798-2013","Class II","Sodium Bicarbonate Powder, CAS-144-55-8, Arm & Hammer, labeled as a) USP2 Grade, packaged in bags of various quantities, Church & Dwight Co, Inc., 469 N. Harrison St., Princeton, NJ 08543-5297; and b) Sodium Bicarbonate U.S.P. No. 2 Fine Granular, Net Wt. 50 lbs. (22.68 kg.) per bag, Manufactured by: Church & Dwight Co., Inc., 469 N. Harrison St., Princeton, N.J. 08543-5297, Product #60211.","Lot #: FF3153, FF3154, FF3155, FF3156, FF3157, and FF3158 ",".","749 tons total","Presence of Foreign Substance: raw material recalled due to stainless steel and other contamination.",6/11/2013,"06/11/2013",7/24/2013,"07/24/2013"
"Drugs",65642,"Ongoing","Church & Dwight Inc","Princeton","NJ","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Nationwide","D-800-2013","Class II","Sodium Bicarbonate Powder, CAS-144-55-8, Arm & Hammer, Sodium Bicarbonate U.S.P. No. 4 Granular, Net Wt. 50 lbs. (22.68 kg.) per bag, Manufactured by: Church & Dwight Co., Inc., 469 N. Harrison St., Princeton, N.J. 08543-5297, Product #60411.","Lot #: FF3153, FF3154, FF3155, FF3156, FF3157, and FF3158 ",".","749 tons total","Presence of Foreign Substance: raw material recalled due to stainless steel and other contamination.",6/11/2013,"06/11/2013",7/24/2013,"07/24/2013"
"Drugs",65642,"Ongoing","Church & Dwight Inc","Princeton","NJ","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Nationwide","D-801-2013","Class II","Sodium Bicarbonate Powder, CAS-144-55-8, Arm & Hammer, labeled as a) USP5 Grade, packaged in bags of various quantities, Church & Dwight Co, Inc., 469 N. Harrison St., Princeton, NJ 08543-5297; and b) Sodium Bicarbonate U.S.P. No. 5 Coarse Granular, Net Wt. 50 lbs. (22.68 kg.) per bag, Manufactured by: Church & Dwight Co., Inc., 469 N. Harrison St., Princeton, N.J. 08543-5297, Product #60511.","Lot #: FF3153, FF3154, FF3155, FF3156, FF3157, and FF3158 ",".","749 tons total","Presence of Foreign Substance: raw material recalled due to stainless steel and other contamination.",6/11/2013,"06/11/2013",7/24/2013,"07/24/2013"
"Drugs",65642,"Ongoing","Church & Dwight Inc","Princeton","NJ","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Nationwide","D-797-2013","Class II","Sodium Bicarbonate Powder, CAS-144-55-8, Arm & Hammer, labeled as a) USP1 Grade, packaged in bags of various quantities, Church & Dwight Co, Inc., 469 N. Harrison St., Princeton, NJ 08543-5297; and b) Sodium Bicarbonate U.S.P. No. 1 Powdered, Net Wt. 50 lbs. (22.68 kg.) per bag, Manufactured by: Church & Dwight Co., Inc., 469 N. Harrison St., Princeton, N.J. 08543-5297, Product #60111.","Lot #: FF3153, FF3154, FF3155, FF3156, FF3157, and FF3158 ",".","749 tons total","Presence of Foreign Substance: raw material recalled due to stainless steel and other contamination.",6/11/2013,"06/11/2013",7/24/2013,"07/24/2013"
"Drugs",65642,"Ongoing","Church & Dwight Inc","Princeton","NJ","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Nationwide","D-799-2013","Class II","Sodium Bicarbonate Powder, CAS-144-55-8, Arm & Hammer, labeled as a) USP3 Grade, packaged in bags of various quantities, Church & Dwight Co, Inc., 469 N. Harrison St., Princeton, NJ 08543-5297; and b) Sodium Bicarbonate U.S.P. No. 3 Fine Powdered, Net Wt. 50 lbs. (22.68 kg.) per bag, Manufactured by: Church & Dwight Co., Inc., 469 N. Harrison St., Princeton, N.J. 08543-5297, Product #60311.","Lot #: FF3153, FF3154, FF3155, FF3156, FF3157, and FF3158 ",".","749 tons total","Presence of Foreign Substance: raw material recalled due to stainless steel and other contamination.",6/11/2013,"06/11/2013",7/24/2013,"07/24/2013"
"Food",65643,"Ongoing","Fisher's Homestyle Salads","Lancaster","PA","US","Voluntary: Firm Initiated","Telephone","1. Esh Foods, L.L.C., located at 58 Hatville Rd; Gordonville, PA 17529 tel # 717-768-8542 Contact: David Esh 2. Landis Foods, located at 679 Hartman Station Road, Lancaster, PA 17602 Tel 717-397-5382 Contact: Lloyd Miller 3. Soup R Salads, located at 2268 Old Philadelphia Pike, Lancaster, PA 17602 Tel # 717-295-3105 Contact: Steve Shenk. Additional quantities (approximately 140 lbs) were sold to customers from the on-site retail counter at Fisher's Homestyle Salads, LLC.","F-1756-2013","Class II","Fisher's Homestyle Salads LLC***Cheddar Potato Soup w/Bacon*** packaged in 5 lb and 10 lb plastic containers.","No sell-by or expiration date code information was included on the package. A 10-day sell-by date was estimated as 7/8/13. ",,,"1) Milk not listed as source of cream, cheese, or butter 2) Undeclared corn ",6/26/2013,"06/26/2013",8/7/2013,"08/07/2013"
"Food",65643,"Ongoing","Fisher's Homestyle Salads","Lancaster","PA","US","Voluntary: Firm Initiated","Telephone","1. Esh Foods, L.L.C., located at 58 Hatville Rd; Gordonville, PA 17529 tel # 717-768-8542 Contact: David Esh 2. Landis Foods, located at 679 Hartman Station Road, Lancaster, PA 17602 Tel 717-397-5382 Contact: Lloyd Miller 3. Soup R Salads, located at 2268 Old Philadelphia Pike, Lancaster, PA 17602 Tel # 717-295-3105 Contact: Steve Shenk. Additional quantities (approximately 140 lbs) were sold to customers from the on-site retail counter at Fisher's Homestyle Salads, LLC.","F-1755-2013","Class II","Fisher's Homestyle Salads LLC***New England Clam Chowder*** packaged in 5 lb and 10 lb plastic containers.","No sell-by or expiration date code information was included on the package. A 7-day sell-by date was estimated as 7/4/13. ",,,"1) Milk not listed in ingredient statement, but listed in allergen warning statement and as a subingredient of sodium caseinate. 2) Undeclared corn 3) Undeclared crab, lobster and shrimp; allergen statement lists ''crustacean shellfish products''",6/26/2013,"06/26/2013",8/7/2013,"08/07/2013"
"Food",65643,"Ongoing","Fisher's Homestyle Salads","Lancaster","PA","US","Voluntary: Firm Initiated","Telephone","1. Esh Foods, L.L.C., located at 58 Hatville Rd; Gordonville, PA 17529 tel # 717-768-8542 Contact: David Esh 2. Landis Foods, located at 679 Hartman Station Road, Lancaster, PA 17602 Tel 717-397-5382 Contact: Lloyd Miller 3. Soup R Salads, located at 2268 Old Philadelphia Pike, Lancaster, PA 17602 Tel # 717-295-3105 Contact: Steve Shenk. Additional quantities (approximately 140 lbs) were sold to customers from the on-site retail counter at Fisher's Homestyle Salads, LLC.","F-1759-2013","Class I","Fisher's Homestyle Salads LLC***Gourmet Crab Cakes*** packaged in 6-piece (36 oz) and 12-piece (72 oz) styrofoam trays.","No sell-by or expiration date code information was included on the package. A 7-day sell-by date was estimated as 7/1/13.",,,"1) undeclared fish 2) undeclared soy lecithin - soy flour listed in ingredient statement 3) undeclared wheat",6/26/2013,"06/26/2013",8/7/2013,"08/07/2013"
"Food",65643,"Ongoing","Fisher's Homestyle Salads","Lancaster","PA","US","Voluntary: Firm Initiated","Telephone","1. Esh Foods, L.L.C., located at 58 Hatville Rd; Gordonville, PA 17529 tel # 717-768-8542 Contact: David Esh 2. Landis Foods, located at 679 Hartman Station Road, Lancaster, PA 17602 Tel 717-397-5382 Contact: Lloyd Miller 3. Soup R Salads, located at 2268 Old Philadelphia Pike, Lancaster, PA 17602 Tel # 717-295-3105 Contact: Steve Shenk. Additional quantities (approximately 140 lbs) were sold to customers from the on-site retail counter at Fisher's Homestyle Salads, LLC.","F-1757-2013","Class II","Fisher's Homestyle Salads LLC***Broccoli Cheese Soup*** packaged in 5 lb and 10 lb plastic containers.","No sell-by or expiration date code information was included on the package. A 10-day sell-by date was estimated as 7/8/13.",,,"1) milk not lsited as source of cream, cheese, or butter ",6/26/2013,"06/26/2013",8/7/2013,"08/07/2013"
"Food",65643,"Ongoing","Fisher's Homestyle Salads","Lancaster","PA","US","Voluntary: Firm Initiated","Telephone","1. Esh Foods, L.L.C., located at 58 Hatville Rd; Gordonville, PA 17529 tel # 717-768-8542 Contact: David Esh 2. Landis Foods, located at 679 Hartman Station Road, Lancaster, PA 17602 Tel 717-397-5382 Contact: Lloyd Miller 3. Soup R Salads, located at 2268 Old Philadelphia Pike, Lancaster, PA 17602 Tel # 717-295-3105 Contact: Steve Shenk. Additional quantities (approximately 140 lbs) were sold to customers from the on-site retail counter at Fisher's Homestyle Salads, LLC.","F-1758-2013","Class II","Fisher's Homestyle Salads LLC***Crab & Shrimp Salad*** packaged in 5 lb and 10 lb plastic containers.","No sell-by or expiration date code information was included on the package. A 7-day sell-by date was estimated as 7/4/13.",,,"1) Undeclared corn 2) undeclared whiting, cod, and/or bream; pollock and whitefish listed in ingredient statement 3) undeclared wheat 4) undeclared Red 40 5) undeclared crab - crab in name of product",6/26/2013,"06/26/2013",8/7/2013,"08/07/2013"
"Devices",65644,"Ongoing","Medtronic MiniMed","Northridge","CA","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution - USA (nationwide) and the countries of Australia, Bermuda, Brazil, Canada, Chile, Columbia, Ecuador, El Salvador, Germany, Japan, Mexico, Netherland, Paraguay, Puerto Rico, Singapore, Uruguay and Venezuela.","Z-1986-2013","Class II","Medtronic MiniMed Paradigm Reservoirs, Model No: MMT-326A (1.8mL) and MMT-332A (3.0mL) The model MMT-326A and MMT-332A are syringe type insulin reservoirs intended for use with Medtronic Paradigm series insulin infusion pumps. The two reservoirs are identical except for barrel length and as a result, maximum insulin capacity. The MMT-326A holds a maximum of 1.8ml of insulin whereas the longer MMT-332A reservoir can hold up to 3.0ml of insulin. Both reservoirs are supplied sterile and are labeled for single use. Typically, the reservoir is replaced every tow or three days at the time of infusion set replacement. The Paradigm reservoirs have a shelf life of three years post sterilization. Product Quantity Distributed (Int) 669,672 units ","MMT-326A Lot Numbers: H8437486 H8441420 H8442973 H8451531 H8486688 H8489386 H8485398 H8500423 H8500472 H8503728 H8512826 H8503372 H8510440 H8539013 H8627745 MMT-332A Lot Numbers: H8416432 H8420977 H8422490 H8424676 H8452933 H8455959 H8457716 H8459557 H8461538 H8463297 H8464121 H8467888 H8469703 H8471745 H8473271 H8476270 H8478398 H8473106 H8492449 H8491921 H8494645 H8496561 H8509305 H8512566 H8515317 H8517079 H8521052 H8541843 H8584244 H8603292 H8604958 H8635301",".","669,672 units","Medtronic is recalling certain lots of Medtronic MiniMed Paradigm Reservoirs MMT-326A (1.8mL) and MMT-332A (3.0mL) used with Medtronic Paradigm insulin pumps because they may have increased risk for leaking. A leak in the reservoir may result in delivery of less insulin than intended. In addition, if there is a leaky reservoir and an insulin blockage occurs in the infusion set, the pump may not alarm to notify users.",7/3/2013,"07/03/2013",8/28/2013,"08/28/2013"
"Food",65645,"Ongoing","Whole Foods Market","Austin","TX","US","Voluntary: Firm Initiated","E-Mail","Retail Stores Nationwide","F-1834-2013","Class I","Crave Brothers Les Freres cheese sold with labeling as: Les Freres, Crave Brothers Les Freres, Les Freres Wash Rind Product of USA, Crave Bros Les Freres, Crave Brothers Les Freres Cheese by Pound, Les Freres Crave Brothers, and Les Freres Crave Brothers PO-RK. Cheese was cut and wrapped.","All best by dates for the following list of PLUs: Les Freres - PLU #299682, Crave Brothers Les Freres - PLU #299682, Les Freres Wash Rind Product of USA - PLU #294473, Crave Bros Les Freres - PLU #294473, Crave Brothers Les Freres Cheese by Pound - PLU #294473, Les Freres Crave Brothers - PLU #294473, and Les Freres Crave Brothers PO-RK - PLU #294473. ",".","Unknown","Whole Foods Market announces that it is recalling Crave Brothers Les Freres cheese in response to a recall by the Crave Brothers Farmstead Cheese Company of Waterloo, Wisconsin. The cheese is being recalled because it has the potential to be contaminated with Listeria monocytogenes, an organism which can cause serious and sometimes fatal infections in young children, frail or elderly people, and others with weakened immune systems. Although healthy individuals may suffer only short-term symptoms such as high fever, severe headache, stiffness, nausea, abdominal pain and diarrhea, Listeria infection can cause miscarriages and stillbirths among pregnant women. To date, one illness and one death have been reported. ",7/4/2013,"07/04/2013",8/28/2013,"08/28/2013"
"Devices",65646,"Ongoing","Stryker Howmedica Osteonics Corp.","Mahwah","NJ","US","Voluntary: Firm Initiated","Letter","US Distribution including the states of IL, KY and TN.","Z-1846-2013","Class II","GAMMA3 System Long Nail Kit, R2.0, Ti, Left Distributed in USA by Howmedica Osteonics Corp., 325 Corporate Drive, Mahwah, NJ 07430 USA A single use device intended for the temporary fixation, correction of stabilization of the right femur. The kit consists of intramedullary nail and set screw. The kit is used in combination with lag screw and (distal) locking screws and end cap as well.","Catalog Number- 33250400S Catalog Number 33250360S ",,"5 units","Stryker Osteosynthesis has become aware that LEFT GAMMA3 nails are marked as right nails.",5/21/2013,"05/21/2013",8/7/2013,"08/07/2013"
"Devices",65647,"Ongoing","Hospira Inc.","Lake Forest","IL","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution - US (nationwide) including the states of IA, IL, MN, SD and WA., and Costa Rica.","Z-1751-2013","Class II","LifeShield; Sterile; Rx only; List No. 19666-28; SYMBIQ PUMP SET, CONVERTIBLE PIN, PIGGYBACK, 2 CLAVES PORTS AND OPTION LOK, NON-DEHP; NOMINAL LENGTH: 97 IN (249 CM); PRIMING VOLUME: 14 ML; For the administration of I.V. fluids; Made in Costa Rica; Hospira, Inc., Lake Forest, IL 60045 USA The Hospira Symbiq Infusion System is a general infusion system which provides IV infusion across the general spectrum of clinical care. The Symbiq pumps are standard sized pumps which are typically facility-based infusion pumps which may be used to deliver continuous and/or intermittent infusions to a variety of patient populations. ","List Number: 19666-04-28; Lot Number: 87-188-5H",".","14,400 units","Hospira has received reports of customers experiencing air-in-line alarms related to administration sets that have a drip chamber with a ball valve. Preliminary investigation findings found that there is a potential for the ball valve to not seal the drip chamber as intended, leading to air in the line of the administration set.",6/18/2013,"06/18/2013",7/24/2013,"07/24/2013"
"Food",65648,"Ongoing","Crave Brothers Farmstead Cheese, LLC","Waterloo","WI","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Direct accounts: CA, CO, FL, GA, IA, IL, MN, WA, and WI","F-1809-2013","Class I","Crave Brothers Farmstead Classics Les Freres Semi-Soft French Style Cheese, LF225. 2.5 lb wheel packaged in cheese paper. Two 2.5 lbs wheels in a case.","Product with a make date of 7-1-13 or prior",,"14,907.76 lbs","Crave Brothers Farmstead Cheese Company is recalling 3 specialty cheese products while regulatory agencies continue a multi-state investigation of Listeria monocytogenes.",7/3/2013,"07/03/2013",8/21/2013,"08/21/2013"
"Food",65648,"Ongoing","Crave Brothers Farmstead Cheese, LLC","Waterloo","WI","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Direct accounts: CA, CO, FL, GA, IA, IL, MN, WA, and WI","F-1811-2013","Class I","Crave Brothers Farmstead Classics Petit Frere with Truffles Cheese, PF88T. Net Wt. 8 oz. (227g). Packaged in cheese paper and sold inside a wooden box. Eight 8 oz. wheels per case.","Product with a make date of 7-1-13 or prior",,"2424 lbs","Crave Brothers Farmstead Cheese Company is recalling 3 specialty cheese products while regulatory agencies continue a multi-state investigation of Listeria monocytogenes.",7/3/2013,"07/03/2013",8/21/2013,"08/21/2013"
"Food",65648,"Ongoing","Crave Brothers Farmstead Cheese, LLC","Waterloo","WI","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Direct accounts: CA, CO, FL, GA, IA, IL, MN, WA, and WI","F-1810-2013","Class I","Crave Brothers Farmstead Classics Petit Frere Soft Ripened Cheese, PF88. Net Wt. 8 oz. (227g). Packaged in cheese paper and sold inside a wooden box. Eight 8 oz wheels per case.","Product with a make date of 7-1-13 or prior",,"8351.5 lbs.","Crave Brothers Farmstead Cheese Company is recalling 3 specialty cheese products while regulatory agencies continue a multi-state investigation of Listeria monocytogenes.",7/3/2013,"07/03/2013",8/21/2013,"08/21/2013"
"Drugs",65650,"Ongoing","Procter & Gamble Co","Mason","OH","US","Voluntary: Firm Initiated","Letter","Nationwide","D-827-2013","Class II","DayQuil Sinex DayTime Sinus Relief (acetaminophen 325 mg and phenylephrine HCl 5 mg) liquicaps and NyQuil Sinex NightTime Sinus Relief (acetaminophen 325 mg, doxylamine succinate 6.25 mg, and phenylephrine HCl 5 mg) liquicaps Combopack, each 48-count liquicaps per carton contains 32 DayQuil Sinex DayTime Liquicaps and 16 NyQuil Sinex NightTime Liquicaps per carton, Made In Canada, Dist. by Procter & Gamble, Cincinnati, OH 45202, UPC 3 23900 01454 1. ","Lot # 3051171961, Exp 09/14; Brand Code 84855363",,"35,568 cartons","Unit Dose Mispackaging: Product packaging defect which could result in code date smearing, incomplete blister card cuts, and missing or incorrectly placed liquicaps within the blisters.",7/3/2013,"07/03/2013",8/7/2013,"08/07/2013"
"Devices",65651,"Ongoing","Siemens Medical Solutions USA, Inc","Malvern","PA","US","Voluntary: Firm Initiated","Letter","Nationwide Distribution and Puerto Rico","Z-1782-2013","Class II","ARTIS zee and zeego x-ray, angiographic system with Software Artis VC20x/VC21A that have Patch 7 and a 3D and DSA license installed. Angiographic x-ray system ","Model numbers: 10094137, 10094139, 10094141, 10280959",,"29","Siemens issued a customer safety advisory notice and field safety corrective action for a potential issue on Artis systems with Artis VC20x/VC21A that have Patch 7 and a 3D and DSA license installed. The issue affects-DSA rotational acquisition. The restriction is related to any rotational 3D-acquisition program with real-time subtraction (e.g. 3D DSA). During the fill phase of the rotational aquisition, the subtraction is not correctly displayed on the live monitor in the control room. As subtracted images are not displayed correctly, this may lead the user to abort or redo the 3D protocol, potentially resulting in the application of an additional dose or contrast agent. 3D data are saved however, and available on the system. ",6/26/2013,"06/26/2013",7/31/2013,"07/31/2013"
"Devices",65652,"Ongoing","Technidata S.A.","Montbonnot St Martin",,"FR","Voluntary: Firm Initiated","Letter","US Distribution CA only.","Z-1743-2013","Class III","TDHistology/Cytology Classification name: Calculator/data processing module for clinical use (862.2100). Intended use: Laboratory Information System (L.I.S)","All TDHistology/Cytology product versions.",".","1 site","A recall was initiated by Technidata because use of symbols (less than or equal to or greater than or equal to or any other symbol) in Microsoft Word reports when using electronic transmissions of results by of HPRIM (including HPRIM Medecin via Kermit) or HL7 must be absolutely prohibited. Such symbols are not supported by the Microsoft Word interface used by the Histology/Cytology software and this could potentially lead to the wrong conversion of symbols less than or equal to or greater than or equal to into ''=''. ",6/20/2013,"06/20/2013",7/24/2013,"07/24/2013"
"Devices",65653,"Ongoing","SpineFrontier, Inc.","Beverly","MA","US","Voluntary: Firm Initiated","E-Mail","Worldwide Distribution - USA, including the states of CT, VA, FL, TX, CO and MS. and the country of Jamaica.","Z-1933-2013","Class II","Indus Invue Screw Caddy, Model: SI70097 The caddy holds, in an organized fashion within the case, a variety of shapes and sizes of plates and screws used during fixation of anterior cervical plates to provide stabilization during the development of spine fusions. There is an array of 108 holes that store 3 types of screws. O4.2mm Self-Drilling, O4.2mm Self-Tapping, and O4.5mm Self-Tapping screws which are separated by type and screw length. The caddy has features to hold the screws in place. ","Lot Numbers: 7140.014; 6486.008 Recall expanded on 8/21/2013 to include lots: 10754.011; 6417.005R, 7140.005, 6486.007; 6486.007R",".","8","Difficulty removing screws from the Invue caddies. ",6/21/2013,"06/21/2013",8/14/2013,"08/14/2013"
"Devices",65654,"Ongoing","Stryker Neurovascular","Fremont","CA","US","Voluntary: Firm Initiated","Letter","International Distribution including Austria, China, and Germany. ","Z-1808-2013","Class II","Stryker brand Neuroform 3 Microdelivery Stent System, 4.5 mm X 20 mm, REF Catalog Number: E345020, Model/Product Number: M003450200, Product is manufactured by Boston Scientific Corporation, Fremont, CA and distributed by Stryker Neurovascular, Fremont, CA The Neuroform Microdelivery Stent System is intended for use with embolic coils for the treatment of wide neck, intracranial, saccular aneurysms arising from a parent vessel with a diameter of greater than equal to 2 mm and greater than equal to 4.5 mm that are not amenable to treatment with surgical clipping.","Code: M003450200, Lot 15391019, Expiration Date: 2015-07",,"23 units","The device is labeled incorrectly, in that, the device Model Number on the outer carton and inner pouch labels did not match, although both referenced the same lot number. The Model Number on the outer box states UPN M003E345020 (4.5mm x 20 mm Neuroform 3 Stent) while the pouch label states UPN M003E3450300 (4.5mm x 30 mm Neuroform 3 Stent). ",6/24/2013,"06/24/2013",7/31/2013,"07/31/2013"
"Devices",65655,"Terminated","Beckman Coulter Inc.","Brea","CA","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution - USA Nationwide and the countries of Belgium, France, Germany, Netherlands, Poland, Spain, Sweden, Switzerland, and United Kingdom","Z-1951-2013","Class II","ISE Electrolyte Reference reagent (for Synchron LX Systems and UniCel DxC 600/800 Systems), Part No. A28937, A28945, 467935, 467915. Product Usage: ISE Electrolyte Buffer reagent and ISE Electrolyte Reference reagent, when used in conjunction with SYNCHRON LX System(s), UniCel DxC 600/800 System(s) and SYNCHRON Systems AQUA CAL 1, 2 and 3, are intended for the quantitative determination of potassium concentration in human serum, plasma or urine.","Lot No. T006042",,"718 units total (132 units in US)","Beckman Coulter is recalling the Synchron Systems LX20/UniCel DxC ISE Reference Reagent because it has a potassium (K) response near the instrument calibration flag limits and may exceed the limits on some instruments.",9/22/2010,"09/22/2010",8/21/2013,"08/21/2013"
"Food",65656,"Ongoing","C Pacific Food","Norwalk","CA","US","Voluntary: Firm Initiated","Letter","TX","F-1750-2013","Class III","Canned Mushroom Sliced 6 cans, 53oz","Carton Code: CONF#4402 Can Code: PRO.03/30/2013 EXP.03/30/2013 3502/01080 805 1 PRO.03/39/2013 EXP.03/29/2016 3502/01080 388 Bar Code: 076215131037",,"159 cartons (954 units)","C. Pacific Foods is recalling canned mushroom sliced because it contains pesticide levels that are not approved for canned mushroom.",6/27/2013,"06/27/2013",7/31/2013,"07/31/2013"
"Devices",65657,"Ongoing","Rauland-Borg Corp","Mount Prospect","IL","US","Voluntary: Firm Initiated","E-Mail","Worldwide distribution - US: (nationwide) including the states of AL, AR, AZ, CA, CO, CT, DE, FL, GA, HI, IL, IN, KS, KY, LA, MA, MI, MN, MO, NC, NE, NV, NY, OH, OK, OR, PA, SD, TN, TX, UT, VA, WA, WI and WV., and the countries of : Australia, Canada, Columbia, Lebanon, Mexico and Saudi Arabia.","Z-2213-2013","Class II","Responder 5 is a nurse call communication system that connects patients with staff in a hospital. The nurse call system also connects team members and departments from radiology, physical therapy, transport, environmental services and more. Responder 5 is used in hospitals and long term patient care facilities to allow for remote communications between patients and patient monitoring devices and healthcare providers","1) Product Code 351000 (Branch Regional Controller); 2) Product Code 352000 (Corridor Light); 3) Product Code 352020 (Domeless Controller)",,"Product Code 351000: 385 units; Product Codes 352000 and 352020: 14,808 units (total)","A counterfeited electronic component was identified in the products affected. The component, a data transceiver (transmitter/receiver), is associated with the intercommunication of these devices in the Responder 5 system across the L-Net data path. Failure of a data transceiver results in the loss of nurse call functionality in the associated room, and may disrupt communications on the L-Net run, affecting nurse call communications across multiple rooms.",5/10/2013,"05/10/2013",9/25/2013,"09/25/2013"
"Biologics",65658,"Terminated","Blood Assurance Inc","Chattanooga","TN","US","Voluntary: Firm Initiated","FAX","Tennessee, Indiana","B-2390-13","Class II","Red Blood Cells Leukocytes Reduced","W043212088253; ",,"1","Blood products, collected from a donor whose suitability to donate was not adequately determined, were distributed.",6/24/2013,"06/24/2013",10/23/2013,"10/23/2013"
"Biologics",65658,"Terminated","Blood Assurance Inc","Chattanooga","TN","US","Voluntary: Firm Initiated","FAX","Tennessee, Indiana","B-2391-13","Class III","Blood and Blood Products for Reprocessing","W043212088253; ",,"1","Blood products, collected from a donor whose suitability to donate was not adequately determined, were distributed.",6/24/2013,"06/24/2013",10/23/2013,"10/23/2013"
"Biologics",65659,"Terminated","Central Texas Regional Blood & Tissue Center","Austin","TX","US","Voluntary: Firm Initiated","FAX","Texas","B-2393-13","Class II","Platelets Pheresis Leukocytes Reduced","W221613606689; W221613606689; ",,"2","Blood products, labeled leukoreduced without the assurance that they met the criteria for leukoreduced products, were distributed.",6/7/2013,"06/07/2013",10/23/2013,"10/23/2013"
"Biologics",65660,"Terminated","The American National Red Cross South Carolina Region","Columbia","SC","US","Voluntary: Firm Initiated","FAX","South Carolina","B-2392-13","Class II","Platelets Pheresis Leukocytes Reduced","36GN35318; ",,"1","Blood product, labeled as leukoreduced which did not meet the requirements for a leukoreduced product, was distributed.",5/14/2013,"05/14/2013",10/23/2013,"10/23/2013"
"Biologics",65661,"Terminated","OneBlood, Inc.","Orlando","FL","US","Voluntary: Firm Initiated","Telephone","Florida","B-2402-13","Class II","Platelets Pheresis Leukocytes Reduced","W038113118478; ",,"1","Blood product, labeled with an extended expiration date, was distributed.",5/28/2013,"05/28/2013",10/23/2013,"10/23/2013"
"Biologics",65662,"Terminated","Stanford Medical School Blood Center","Palo Alto","CA","US","Voluntary: Firm Initiated","Letter","California","B-2394-13","Class II","Red Blood Cells Leukocytes Reduced","W070512317619; ",,"1","Blood product, collected from a donor who visited a malarial endemic area, was distributed. ",6/3/2013,"06/03/2013",10/23/2013,"10/23/2013"
"Drugs",65663,"Ongoing","Stayma Consulting Service, LLC.","Suwanee","GA","US","Voluntary: Firm Initiated","Letter","Nationwide.","D-896-2013","Class III","Duet DHA 400 ec, containing one 30-count bottle of multi-vitamin tablets (imprinted 800) and one 30-count bottle of Omega-3 softgel capsules, Rx only, Manufactured for Eckson Labs, Wilmington, DE (NDC 44118-809-30) and Manufactured for W.H. Nutritionals, Wilmington, DE (NDC 76331-809-30)","NDC 44118-809-30; Lot 40614B, exp. 9/14 and NDC 76331-809-30; lot 39736A, exp. 3/2014, ",".","NDC 44118-809-30; 747 and NDC 76331-807-30; 1493","Subpotent; Beta carotene (Vitamin A)",6/28/2013,"06/28/2013",8/28/2013,"08/28/2013"
"Drugs",65663,"Ongoing","Stayma Consulting Service, LLC.","Suwanee","GA","US","Voluntary: Firm Initiated","Letter","Nationwide.","D-900-2013","Class III","Nata Komplete, containing one 30-count bottle of multi-vitamin tablets (imprinted 909), Manufactured for W.H. Nutritionals, Wilmington, DE (NDC 76331-909-30) and physician samples of nine bottles of 5-multi-vitamin tablets (NDC 76331-909-05 ) ","NDC 76331-909-30; Lot 40186, exp 5/14 NDC 76331-909-05; Lot 40186, exp. 5/14 (physician samples) ",".","1974 and 3967 physician samples","Subpotent; Beta carotene (Vitamin A)",6/28/2013,"06/28/2013",8/28/2013,"08/28/2013"
"Drugs",65663,"Ongoing","Stayma Consulting Service, LLC.","Suwanee","GA","US","Voluntary: Firm Initiated","Letter","Nationwide.","D-894-2013","Class III","Duet DHA Balanced, 1) 30 count tablet blister cards and 5 count softgels blister cards combination pack (NDC 44118-775-30 and NDC 44118-800-30) 2) physician samples (carton contain 7 envelopes each with one 5 count tablet blister card and 5 softgels (NDC 44118-800-05) Rx only, Manufactured for Eckson Labs, Wilmington, DE ","1) NDC 44118-775-30, Lots 12120001, exp. 10/14 and 12120002, exp. 10/14; NDC 44118-800-30, Lots 12120001, exp 10/14 and 12080002, exp 8/14 2) Physician Samples: NDC 44118-800-05, Lot 12080001 exp. 8/14 and 12120002, exp. 10/14",".","1) 12,278 and 28476; 2) 23740","Subpotent; Beta carotene (Vitamin A)",6/28/2013,"06/28/2013",8/28/2013,"08/28/2013"
"Drugs",65663,"Ongoing","Stayma Consulting Service, LLC.","Suwanee","GA","US","Voluntary: Firm Initiated","Letter","Nationwide.","D-897-2013","Class III","NataChew, 1) one 90-count bottle of multi-vitamin tablets (imprinted 902), (NDC 44118-902-90) and 2) physician samples containing nine bottles with 5 multi-vitamin tablets (imprinted 902) (NDC 44118-902-05), Manufactured for Eckson Labs, Wilmington, DE ","1) Lot 41065, exp 10/14 and 41099, exp 9/14 NDC 44118-902-90 2) Lot 41065A, exp. 9/14 NDC 44118-902-05",".","1) 4546 bottles and 2) 1349 bottles","Subpotent; Beta carotene (Vitamin A)",6/28/2013,"06/28/2013",8/28/2013,"08/28/2013"
"Drugs",65663,"Ongoing","Stayma Consulting Service, LLC.","Suwanee","GA","US","Voluntary: Firm Initiated","Letter","Nationwide.","D-895-2013","Class III","Duet DHA 400, containing one 30-count bottle of multi-vitamin tablets (imprinted 800) and one 30-count bottle of Omega-3 softgel capsules, Rx only, Manufactured for Eckson Labs, Wilmington, DE (NDC 44118-807-30) --- Also Manufactured for W.H. Nutritionals, Wilmington, DE (NDC 76331-807-30)","NDC 44118-807-30 Lots 40614, exp. 9/14 and 40614A, exp. 9/14 NDC 76331-807-30 lot 39736A, exp. 3/2014, and lot 41667, exp. 12/2014",".","1,460 and 2,990","Subpotent; Beta carotene (Vitamin A)",6/28/2013,"06/28/2013",8/28/2013,"08/28/2013"
"Drugs",65663,"Ongoing","Stayma Consulting Service, LLC.","Suwanee","GA","US","Voluntary: Firm Initiated","Letter","Nationwide.","D-899-2013","Class III","Duet DHA 430 ec, containing one 30-count bottle of multi-vitamin tablets (imprinted 800) and one 30-count bottle of Omega-3 softgel capsules, Manufactured for W.H. Nutritionals, Wilmington, DE (NDC 76331-810-30)","NDC 76331-810-30; Lot 39736A, exp. 3/14 ",".","1492","Subpotent; Beta carotene (Vitamin A)",6/28/2013,"06/28/2013",8/28/2013,"08/28/2013"
"Drugs",65663,"Ongoing","Stayma Consulting Service, LLC.","Suwanee","GA","US","Voluntary: Firm Initiated","Letter","Nationwide.","D-898-2013","Class III","Duet DHA 430, containing one 30-count bottle of multi-vitamin tablets (imprinted 800) and one 30-count bottle of Omega-3 softgel capsules, Manufactured for W.H. Nutritionals, Wilmington, DE --- NDC 76331-808-30 ","NDC 76331-808-30; lot 39736A, exp. 3/14 and lot 41667, exp. 12/14 ",".","2985","Subpotent; Beta carotene (Vitamin A)",6/28/2013,"06/28/2013",8/28/2013,"08/28/2013"
"Devices",65664,"Ongoing","KooJoo Trading Company","Gimpo City, Gyeongki-Do",,"KR","Voluntary: Firm Initiated","Letter","US Distribution GA only.","Z-1729-2013","Class II","Safety Lancets - Odyssey, Button Activated; Tri- Bevel Tip for Virtually Painless Sampling; Needle automatically retracts, No lancing device required. 26G - Single Use Only, Made In Korea Distributed by Hummingbird Medical, Savannah, GA 100 count Boxes; 40 boxes per case Blood collection by penetrating skin with needle.","Lot # HBM1303-4886, Exp 3/6/2016; Lot# HBM1303-4886, Exp 3.6 to 3/21/2016; Lot# HBM1201-02, Exp 1/16/2015; Lot# HBM1203-02, Exp 4/5/2015",".","7, 712, 000 pieces (1928 cartons)","Lancets were not sterilized within the dose range established by sterilization validation.",7/3/2013,"07/03/2013",7/24/2013,"07/24/2013"
"Food",65665,"Ongoing","Ozark Bottling, LLC","Lake Ozark","MO","US","Voluntary: Firm Initiated","Telephone","Distribution was made to OH.","F-1745-2013","Class III","Lehman's Hot Veggie Mix, packaged in 12/16-oz jars per case, distributed by Lehman's, Kidron, OH 44636","Lot 050815",,"2/12/16-oz jar/cases","The pH levels of these products are not accurately measured due to the use of outdated buffers and pH levels do not meet process specifications.",7/3/2013,"07/03/2013",8/7/2013,"08/07/2013"
"Devices",65666,"Ongoing","Picis Inc.","Wakefield","MA","US","Voluntary: Firm Initiated","Letter","Nationwide Distribution, including the states of: AK, AR, AZ, CA, CO, DC, DE, FL, GA, ID, IN, MA, MD, MO, NH, NJ, OH, OR, SC, TN, WA, and WV.","Z-1814-2013","Class II","Picis ED Pulsecheck - EMR Software Application - 2125, Software Versions: 5.2 and 5.3. The application stores patient information in a database, and it may analyze and/or display the data in different formats for evaluation by healthcare professionals for informational purposes.","Software Versions 5.2 and 5.3",,"35","Notes associated with prescription are not printed to the prescription or to the patient chart. ",6/21/2013,"06/21/2013",8/7/2013,"08/07/2013"
"Devices",65668,"Ongoing","Synthes USA HQ, Inc.","West Chester","PA","US","Voluntary: Firm Initiated","Letter","US distribution: PA only. .","Z-1821-2013","Class II","Synthes Synapse SD Drill Guide, Part Number SD389.477, Lot Number 6913900 Indicated for Hooks, Plate/Rods, Rods and Screws when intended to promote fusion of the cervical spine fusion of the cervical spine and occipitocervical junction (occiput-T3), the plate/rod, rod, hook and screw (3.2 mm cortex) components of the Synthes Cervifix; Axon and Synapse Systems are indicated for the following: -Degenerative Disk Disease (DDD) (defined as neck pain of discogenic origin with degeneration of the disc as confirmed by patient history and radiographic studies); -Spondylolisthesis; -Spinal Stenosis; -Fracture/dislocation; -Atlantoaxial fracture with instability; -Occipitocervical dislocation; -Revision of previous cervical spine surgery; and -Tumo","Part Number SD389.477, Lot Number 6913900",,"2","A complaint was received from the field, that the drill guide was etched incorrectly, 12mm etch instead of 18mm drill guide. The firm identified that this constituted a field action and retrospectively reported this action.",10/12/2012,"10/12/2012",8/7/2013,"08/07/2013"
"Devices",65669,"Ongoing","Synthes USA HQ, Inc.","West Chester","PA","US","Voluntary: Firm Initiated","Letter","US Distribution including the states of CA, MN, NC and TN.","Z-1816-2013","Class II","Synthes Large External Fixation, MR Conditional, Tube to Tube Clamp, Part Number 390.007, Lot Number 6800599 Synthes Large External Fixation is intended for use to provide treatment for long bone and pelvic fractures that require external fixation."," Part Number 390.007, Lot Number 6800599",,"8","It was discovered internally that there was a discrepancy between the insert provided with the Tube to Tube Clamp and what was called for in the Bill of Materials. Following a detailed investigation, it was determined that the incorrect insert was used which indicates that the device is MR Safe, when it is actually MR Conditional.",10/12/2012,"10/12/2012",8/7/2013,"08/07/2013"
"Devices",65670,"Ongoing","Synthes USA HQ, Inc.","West Chester","PA","US","Voluntary: Firm Initiated","Letter","Nationwide Distribution including PA, CT, DE, and NY.","Z-1726-2013","Class II","Synthes CMF Distraction System The product is intended for use as a bone stabilizer and lengthening (and/or transport) device for correction of congenital deficiencies or post-traumatic defects of the mandibular body and ramus, where gradual bone distraction is required. It is intended for single use only. ","Part # 04.315.067 with lot #s 6184270 and/or 22612-04.",".","10","The firm initiated a voluntary recall of the BC Distractor Body which is part of the Craniomaxillofacial (CMF) Distractor System, due to a mis-alignment issue. There have been instances reported within the impacted lots in which the slot in the barrel of the BC distractor was rotated such that it was not possible to attach the B-type and C-type foot plates. ",6/12/2013,"06/12/2013",7/24/2013,"07/24/2013"
"Veterinary",65671,"Ongoing","Manna Pro Corp","Chesterfield","MO","US","Voluntary: Firm Initiated","E-Mail","The product was distributed to OK, WI, KS, IA, MO, AR, MN and IL.","V-295-2013","Class III","MannaPro Goat Treats, Licorice Flavor, 6 lb bag, Manufactured by: MannaPro, St. Louis, MO. Positive Pellet Goat Dewormer packed in Goat Treat bags packaged in Positive Pellet Goat Dewormer shipping boxes. The Positive Pellet Goat Dewormer contains 880 gram Morantel Tartrate per ton.","''MADE K 06/01/13''",,"69/6/6-lb bag/cases","Positive Pellet goat dewormer (medicated) is packaged in Goat Treats bags.",7/8/2013,"07/08/2013",8/21/2013,"08/21/2013"
"Devices",65672,"Ongoing","Alphatec Spine, Inc.","Carlsbad","CA","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Worldwide distribution: US (nationwide) including states of:US states: AZ, CA, FL, GA, IL, MD, NJ, NY, OK, PA, TN, TX,and WA ; and countries of: Spain, France, Japan. International: Spain, France, Japan.","Z-2086-2013","Class II","Illico Ti Cannulated Polyaxial Screw 7.5mm X 40mm. The Illico MIS Posterior Fixation System is intended to facilitate the surgical correction of noncervical spinal deformities by providing temporary internal fixation and stabilization during bone graft healing and/or fusion mass development.","Part Number 73875-40. Lots Affected: 647289, 648923, 649244, 649556, 649813, 650040, 650262, 650589.",,"333 screws","The firm initiated this recall of certain lots of Illico Ti Cannulated Polyaxial Screws 7.5mm x 40mm implants, due to an off-center cannulation hole at the proximal end of the bone screw. There is a potential risk that when the screw is mated to a polyaxial screwdriver, the guide wire may not pass through the screwdriver.",6/28/2013,"06/28/2013",9/4/2013,"09/04/2013"
"Biologics",65673,"Terminated","OneBlood, Inc.","Hialeah","FL","US","Voluntary: Firm Initiated","Letter","Florida","B-2388-13","Class II","Platelets Pooled Leukocytes Reduced Irradiated","W036812853051; ",".","1","Blood products, collected from a donor whose suitability to donate was not adequately determined, were distributed.",6/25/2013,"06/25/2013",11/20/2013,"11/20/2013"
"Biologics",65673,"Terminated","OneBlood, Inc.","Hialeah","FL","US","Voluntary: Firm Initiated","Letter","Florida","B-2387-13","Class II","Red Blood Cells Leukocytes Reduced","W036812590578; ",".","1","Blood products, collected from a donor whose suitability to donate was not adequately determined, were distributed.",6/25/2013,"06/25/2013",11/20/2013,"11/20/2013"
"Biologics",65673,"Terminated","OneBlood, Inc.","Hialeah","FL","US","Voluntary: Firm Initiated","Letter","Florida","B-2389-13","Class III","Blood and Blood Products for Reprocessing","W036812590578; ",".","1","Blood products, collected from a donor whose suitability to donate was not adequately determined, were distributed.",6/25/2013,"06/25/2013",11/20/2013,"11/20/2013"
"Biologics",65675,"Terminated","New York Blood Center, Inc.","Westbury","NY","US","Voluntary: Firm Initiated","FAX","New York","B-2401-13","Class III","Platelets Pheresis Leukocytes Reduced","W047013208805; W047013208805; ",".","2","Blood products, held in quarantine pending results of an investigation, were distributed.",5/31/2013,"05/31/2013",11/20/2013,"11/20/2013"
"Drugs",65676,"Ongoing","Braintree Laboratories Inc.","Holbrook","MA","US","Voluntary: Firm Initiated","Letter","Nationwie","D-911-2013","Class III","Braintree HalfLytely and Bisacodyl Tablet Bowel Prep Kit (Rx) NDC 52268-523-02","Lot 3013002 Exp. 08/14",".","10,362 kit cartons ","Defective Container; Small micro fracture observed in the 2-Liter bottle at the fill line resulting in a small leak when patient reconstitutes the bulk powder",7/15/2013,"07/15/2013",8/28/2013,"08/28/2013"
"Devices",65677,"Ongoing","Zimmer, Inc.","Warsaw","IN","US","Voluntary: Firm Initiated",,"Worldwide Distribution - USA (nationwide) including the countries of Singapore, Brazil, Taiwan, Australia, Canada, Germany(with further distribution to UAE, Austria, Belgium, Switzerland, Czech Republic, Denmark, Spain, Finland, France, Greece, Israel, Italy, Malta, Norway, Portugal, Sweden and South Africa,","Z-2055-2013","Class II","00 4309-049-00 Trabecular Metal Reverse Shoulder Glenosphere Distractor Rx, Non sterile (sterilize before use) The Glenosphere Distractor must be able to attach, connect, or mate with the Glenosphere and remove it without dislodging or loosening the base plate from the glenoid, or damaging the glenoid. Pulling the trigger releases a weight inside the Distractor. This force is transmitted to the bottom of the glenosphere dislodging it from the base plate. ","Item # 00-4309-049-00 and Lot Numbers: 60452884, 60461858, 60531990, 60549559, 60605842, 60612781, 60684768, 60754281, 60815778, 60909547, 60959086, 60978338, 61029048, 61135953, 61213252, 61274877, 61334929, 61431672, 61566464, 61594740, 61690097, 61756058, 61857748, 61858851, 61889174, 61906350, 61910781, 61918666 62039450, 62096379, 62101249, 62141887, 62160965, 62215378, 62254111, 62269856, 62304206, and 62311096. ",,"771","Zimmer is initiating a lot specific recall of the Trabecular Metal'' Reverse Glenosphere Distractor due to the potential of the device not functioning properly should it be utilized without proper lubrication. As a result, there is a potential for the device to fail to provide impact to the Glenosphere when the trigger is pulled. In addition, there is a potential for the foot of the device to fracture during use which may result in the device being unable to remove the Glenosphere. There have been 17 reported complaints of the device failing to provide impact and 8 reported complaints of the foot fracturing. In the U.S.,these devices were distributed between March 13, 2006 and March 22, 2013.",8/1/2013,"08/01/2013",9/4/2013,"09/04/2013"
"Devices",65678,"Ongoing","Atrium Medical Corporation","Hudson","NH","US","Voluntary: Firm Initiated","Letter","Nationwide Distribution.","Z-1987-2013","Class II","PleuraGuide Disposable Chest Tube Kit; Product codes: 17100, 17150, and 17200. Indicated to assist with the insertion of thoracic catheters.","Part Number: 17100: 10734588, 10734583, 10728237, 10728236, 10728235, 10728234, 10736244, 10736243, 10736242, 10736238, 10734590, 10734589, 10736245, 10852352, 10847222, 10847218, 10842301, 10842299, 10842297, 10840114, 10834292, 10829188, 10852337, 10852334, 10834291, 10834286, 10834284, 10860795, 10857119, 10857111, 10864592, 10864104, 10856867, 10875059, 10875046 , 10871063, 10871059, 10868989, 10879191, 10879190, 10889037, 10887634, 10887292, 10884093, 10879192, 10891329, 10884084;Part Number: 17150: 10728238, 10734584, 10823084, 10800926, 10827874, 10827874, 10834299, 10857110, 10881097, 10874228, 10867130; Part Number 17200: 10728239, 10734585, 10794372, 10802727, 10802725, 10820803, 10825183, 10834338, 10852339, 10864105, 10884087 ",".","6,516 units","Individual component's IFUs are not included with the kit. ",7/16/2013,"07/16/2013",8/28/2013,"08/28/2013"
"Devices",65679,"Ongoing","Pemco Inc","Independence","OH","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution - USA including AL, CA, CT, FL, GA, ID, IL, IN, KS, KY, LA, MA, MD, MI, MO, MS, NC, NJ, NM, NV, OK, PA, TN, TX, UT, VA & WA. Internationally to Czech Republic, Italy, Japan, Korea & Singapore.","Z-1783-2013","Class II","Rultract Retractor Ratchet Cover Plate Distributed by Pemco, Inc., Cleveland, OH 44131 Surgical retractor used to lift the incision site","M/N 4100-IMR-6: S/N's: 4829-4839, 4845-4851, 4857-4871, 4874-4884, 4894-4908 & 4916-4923; M/N 4100-IMR-41: S/N's: 4840-4844, 4852-4856, 4888-4893, 4913-4915 & 4926-4927.",,"87 units","The firm became aware of the problem when a ratchet cover plate on a device was returned for repair showed signs of corrosion.",7/10/2013,"07/10/2013",7/31/2013,"07/31/2013"
"Biologics",65680,"Terminated","The Blood Center","New Orleans","LA","US","Voluntary: Firm Initiated","Telephone","Louisiana","B-2400-13","Class II","Platelets Pheresis Leukocytes Reduced","W067113705080; ",".","1","Blood product, manufactured from an apheresis unit with insufficient platelet yield for the unit to be split, was distributed. ",6/13/2013,"06/13/2013",11/20/2013,"11/20/2013"
"Biologics",65681,"Terminated","The Blood Center","New Orleans","LA","US","Voluntary: Firm Initiated","Telephone","Louisiana","B-2429-13","Class II","Platelets Pheresis Leukocytes Reduced","W067113704370; ",".","1","Donor Screening/Deferral screening not done or incorrectly performed, including incorrect ID used during search, prior deferral due to history.",6/2/2013,"06/02/2013",11/20/2013,"11/20/2013"
"Biologics",65681,"Terminated","The Blood Center","New Orleans","LA","US","Voluntary: Firm Initiated","Telephone","Louisiana","B-2427-13","Class II","Fresh Frozen Plasma (Apheresis)","W067113704370; ",".","1","Donor Screening/Deferral screening not done or incorrectly performed, including incorrect ID used during search, prior deferral due to history.",6/2/2013,"06/02/2013",11/20/2013,"11/20/2013"
"Biologics",65681,"Terminated","The Blood Center","New Orleans","LA","US","Voluntary: Firm Initiated","Telephone","Louisiana","B-2428-13","Class II","Platelets Pheresis Leukocytes Reduced Irradiated","W067113704370; ",".","1","Blood products, collected from a donor who had been temporarily deferred, were distributed.",6/2/2013,"06/02/2013",11/20/2013,"11/20/2013"
"Biologics",65682,"Terminated","Michigan Blood","Grand Rapids","MI","US","Voluntary: Firm Initiated","FAX","Michigan","B-2398-13","Class II","Fresh Frozen Plasma","W120613000269; ",".","1","Blood product, collected from a donor considered to be at increased risk for Creutzfeldt-Jakob Disease (CJD), was distributed.",5/20/2013,"05/20/2013",11/20/2013,"11/20/2013"
"Drugs",65683,"Completed","American Health Packaging","Columbus","OH","US","Voluntary: Firm Initiated","Letter","Nationwide","D-802-2013","Class II","QUETIAPINE Fumarate Tablets 25mg 100 Tablets (10x10) Blister card, Rx, Packaged and Distributed by: American Health Packaging, Columbus, Ohio 43217, NDC 68084-530-01","Lot 122600 Exp. 03/14",".","19060 blister cards","Failed Dissolution Test Requirements: During analysis of long term stability studies at 3 months time point, an OOS was reported for Quetiapine Fumarate Tablets, 25 mg.",10/10/2012,"10/10/2012",7/24/2013,"07/24/2013"
"Biologics",65684,"Terminated","Delta Blood Bank","Stockton","CA","US","Voluntary: Firm Initiated","Letter","CA.","B-2568-13","Class II","Red Blood Cells Leukocytes Reduced","W128712017309",,"1 unit","Blood product, collected from a donor who reported travel through a malarial endemic area, was distributed.",5/3/2013,"05/03/2013",11/27/2013,"11/27/2013"
"Devices",65686,"Ongoing","Church & Dwight Inc","Princeton","NJ","US","Voluntary: Firm Initiated","Telephone","Nationwide Distribution including IL, PA, IN, OH, MI, TN, TX, MN, MO, NJ, KY,and MD.","Z-1811-2013","Class II","Sodium Bicarbonate, USP Provided bulk as raw material - label not applicable according to firm Dialysis Grade 1.5 Dialysis Grade 2 As an API or excipient in the manufacture of Medical Devices and Drugs","Lots and sizes- 20015437 SBC DIALYSIS 1.5 GRADE 2500 LB SACK 20015437 SBC DIALYSIS 1.5 GRADE 2500 LB SACK 20015437 SBC DIALYSIS 1.5 GRADE 2500 LB SACK 20015437 SBC DIALYSIS 1.5 GRADE 2500 LB SACK 20015437 SBC DIALYSIS 1.5 GRADE 2500 LB SACK 20015437 SBC DIALYSIS 1.5 GRADE 2500 LB SACK 20015437 SBC DIALYSIS 1.5 GRADE 2500 LB SACK 20015437 SBC DIALYSIS 1.5 GRADE 2500 LB SACK 20015437 SBC DIALYSIS 1.5 GRADE 2500 LB SACK 20015437 SBC DIALYSIS 1.5 GRADE 2500 LB SACK 20015437 SBC DIALYSIS 1.5 GRADE 2500 LB SACK 20015437 SBC DIALYSIS 1.5 GRADE 2500 LB SACK 20015437 SBC DIALYSIS 1.5 GRADE 2500 LB SACK 20015443 SBC DIALYSIS 2 GRADE 50 LB BAG ",,"234 sacks at 2500 lbs. each of Dialysis Grade 1.5 ; 880 bags at 50 lbs. each of Dialysis Grade 2 ","Church and Dwight Co., Inc. has initiated a recall for Sodium Bicarbonate, USP produced by the Old Fort, OH Sodium Bicarbonate Production facility due to metal and other contamination.",6/11/2013,"06/11/2013",7/31/2013,"07/31/2013"
"Food",65687,"Ongoing","Priester Pecan Company, Inc.","Fort Deposit","AL","US","Voluntary: Firm Initiated","Other","Nationwide and Puerto Rico","F-1731-2013","Class I","PRIESTER'S PECANS brand NUTTY FAVORITES ASST, Stock No. 79, Net Wt 1 lb 10 oz (737g)","The product is not coded.",,"777 units (4 oz)","Pistachios, which were supplied by ARO and subsequently recalled, have the potential to be contaminated with Salmonella.",6/28/2013,"06/28/2013",7/31/2013,"07/31/2013"
"Food",65687,"Ongoing","Priester Pecan Company, Inc.","Fort Deposit","AL","US","Voluntary: Firm Initiated","Other","Nationwide and Puerto Rico","F-1730-2013","Class I","PRIESTER'S PECANS brand brand ROASTED SALTED PISTACHIOS, item #18010, Net Wt. 1 lb (454g), UPC 720056180104; item #15502, Net Wt. 8 oz (226.8g), UPC 001001155027; Stock No. 189, Net Wt. 2 lb (907g)","The product is not coded.",,"701.5 pounds","Pistachios, which were supplied by ARO and subsequently recalled, have the potential to be contaminated with Salmonella.",6/28/2013,"06/28/2013",7/31/2013,"07/31/2013"
"Food",65687,"Ongoing","Priester Pecan Company, Inc.","Fort Deposit","AL","US","Voluntary: Firm Initiated","Other","Nationwide and Puerto Rico","F-1732-2013","Class I","PRIESTER'S PECANS brand FANCY ROASTED NUTS, Stock No. 7, Net Wt 12 oz (454g) ","The product is not coded.",,"268 units of 3 oz","Pistachios, which were supplied by ARO and subsequently recalled, have the potential to be contaminated with Salmonella.",6/28/2013,"06/28/2013",7/31/2013,"07/31/2013"
"Food",65687,"Terminated","Priester Pecan Company, Inc.","Fort Deposit","AL","US","Voluntary: Firm Initiated","Other","Nationwide and Puerto Rico","F-1731-2013","Class I","PRIESTER'S PECANS brand NUTTY FAVORITES ASST, Stock No. 79, Net Wt 1 lb 10 oz (737g)","The product is not coded.",".","777 units (4 oz)","Pistachios, which were supplied by ARO and subsequently recalled, have the potential to be contaminated with Salmonella.",6/28/2013,"06/28/2013",11/20/2013,"11/20/2013"
"Food",65687,"Terminated","Priester Pecan Company, Inc.","Fort Deposit","AL","US","Voluntary: Firm Initiated","Other","Nationwide and Puerto Rico","F-1730-2013","Class I","PRIESTER'S PECANS brand brand ROASTED SALTED PISTACHIOS, item #18010, Net Wt. 1 lb (454g), UPC 720056180104; item #15502, Net Wt. 8 oz (226.8g), UPC 001001155027; Stock No. 189, Net Wt. 2 lb (907g)","The product is not coded.",".","701.5 pounds","Pistachios, which were supplied by ARO and subsequently recalled, have the potential to be contaminated with Salmonella.",6/28/2013,"06/28/2013",11/20/2013,"11/20/2013"
"Food",65687,"Terminated","Priester Pecan Company, Inc.","Fort Deposit","AL","US","Voluntary: Firm Initiated","Other","Nationwide and Puerto Rico","F-1732-2013","Class I","PRIESTER'S PECANS brand FANCY ROASTED NUTS, Stock No. 7, Net Wt 12 oz (454g) ","The product is not coded.",".","268 units of 3 oz","Pistachios, which were supplied by ARO and subsequently recalled, have the potential to be contaminated with Salmonella.",6/28/2013,"06/28/2013",11/20/2013,"11/20/2013"
"Devices",65688,"Terminated","Topcon Medical Laser Systems, Inc","Santa Clara","CA","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution-USA and the countries of China, Hong Kong, Brazil, France, Japan, Netherlands, Pakistan, Malaysia, United Kingdom, South Korea, Thailand, Dubai, and South Africa.","Z-1774-2013","Class II","PASCAL and PASCAL Streamline (532 nm.577 nm); Treats the patient's eye.","PASCAL Standard 2R/G System v2.x.x and PASCAL Streamline 2R/G Software v2.x.x Serial numbers: United States 33057910 33060410 33063610 66078611 66084911 66085111 66085511 Out of United States OMC-179 11138509 11141209 11147209 11147809 11148910 11149010 11149210 11149710 . 11149810 11150110 11150210 11150410 11150610 11150810 11150910 11151010 1 151110 11151211 33054310 33059310 33059510 33062810'' 66075211' 66076711 66077111 66078011 66079911 6608391'1 66084611 66084811 66085011 66085211 ",,"7 US, 33 foreign","When using the ''Favorites'' function for saved settings, there is potential for a mismatch between displayed power and the actual power output. This may result in over or under treatment.",3/27/2012,"03/27/2012",7/31/2013,"07/31/2013"
"Devices",65689,"Ongoing","Hospira Inc.","Lake Forest","IL","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution - USA (nationwide) and Puerto Rico and Internationally to Costa Rica.","Z-1851-2013","Class I","List No. 14203-28; BLOOD SET; 200 Micron Filter, 80 Inch, Non-DEHP; For Blood Product Administration; Made in Costa Rica; Product Inquiries should be directed to Hospira., Inc., Lake Forrest, IL 60045 USA Hospira Blood sets are designed for Blood Product Administration","List Number: 14203-28; Lot Numbers: 030895H, 961465H",".","1,152 units","It was discovered that there was a potential for the piercing pin on certain Hospira blood sets to puncture the outer wall of blood bags during insertion of the pin into the blood bag. ",4/1/2013,"04/01/2013",8/14/2013,"08/14/2013"
"Devices",65689,"Ongoing","Hospira Inc.","Lake Forest","IL","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution - USA (nationwide) and Puerto Rico and Internationally to Costa Rica.","Z-1852-2013","Class I","List No. 14206-28; Y-TYPE BLOOD SET; 200 Micron Filter, Cylinder Pump, Convertible Pin and Non-Vented Pin, 80 Inch, Non-DEHP; For Blood Product Administration; Made in Costa Rica; Product Inquiries should be directed to Hospira., Inc., Lake Forrest, IL 60045 USA Hospira Blood sets are designed for Blood Product Administration","List Number: 14206-28; Lot Numbers: 020695H, 100865H",".","1,976 units","It was discovered that there was a potential for the piercing pin on certain Hospira blood sets to puncture the outer wall of blood bags during insertion of the pin into the blood bag. ",4/1/2013,"04/01/2013",8/14/2013,"08/14/2013"
"Devices",65689,"Ongoing","Hospira Inc.","Lake Forest","IL","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution - USA (nationwide) and Puerto Rico and Internationally to Costa Rica.","Z-1857-2013","Class I","List No. 14217-28; Y-TYPE BLOOD SET; 200 Micron Filter, Prepierced Y-Site, Non-Vented, 80 Inch, Non-DEHP; For Blood Product Administration; Made in Costa Rica; Product Inquiries should be directed to Hospira., Inc., Lake Forrest, IL 60045 USA Hospira Blood sets are designed for Blood Product Administration","List Number: 14217-28; Lot Number: 962255H",".","1,104 units","It was discovered that there was a potential for the piercing pin on certain Hospira blood sets to puncture the outer wall of blood bags during insertion of the pin into the blood bag. ",4/1/2013,"04/01/2013",8/14/2013,"08/14/2013"
"Devices",65689,"Ongoing","Hospira Inc.","Lake Forest","IL","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution - USA (nationwide) and Puerto Rico and Internationally to Costa Rica.","Z-1854-2013","Class I","List No. 14210-28; PLUM BLOOD SET; 100 mL Burette with Prepierced Injection Site, 170 Micron Filter, Prepierced Port, Non-Vented, 105 Inch, Non-DEHP; For Blood Product Administration; Made in Costa Rica; Product Inquiries should be directed to Hospira., Inc., Lake Forrest, IL 60045 USA Hospira Blood sets are designed for Blood Product Administration","List Number: 14210-28; Lot Number: 053835H",".","96 units","It was discovered that there was a potential for the piercing pin on certain Hospira blood sets to puncture the outer wall of blood bags during insertion of the pin into the blood bag. ",4/1/2013,"04/01/2013",8/14/2013,"08/14/2013"
"Devices",65689,"Ongoing","Hospira Inc.","Lake Forest","IL","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution - USA (nationwide) and Puerto Rico and Internationally to Costa Rica.","Z-1850-2013","Class I","List No. 14200-28; SECONDARY BLOOD SET; 200 Micron Filter, 36 Inch, Non-DEHP; For Blood Product Administration; Made in Costa Rica; Product Inquiries should be directed to Hospira., Inc., Lake Forrest, IL 60045 USA Hospira Blood sets are designed for Blood Product Administration","List Number: 14200-28; Lot Numbers: 022045H, 022055H, 030605H, 201765H",".","672 units","It was discovered that there was a potential for the piercing pin on certain Hospira blood sets to puncture the outer wall of blood bags during insertion of the pin into the blood bag. ",4/1/2013,"04/01/2013",8/14/2013,"08/14/2013"
"Devices",65689,"Ongoing","Hospira Inc.","Lake Forest","IL","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution - USA (nationwide) and Puerto Rico and Internationally to Costa Rica.","Z-1853-2013","Class I","List No. 14207-28; BLOOD SET; 200 Micron Filter, 105 Inch, Non-DEHP; For Blood Product Administration; Made in Costa Rica; Product Inquiries should be directed to Hospira., Inc., Lake Forrest, IL 60045 USA Hospira Blood sets are designed for Blood Product Administration","List Number: 14207-28; Lot Number: 962295H",".","240 units","It was discovered that there was a potential for the piercing pin on certain Hospira blood sets to puncture the outer wall of blood bags during insertion of the pin into the blood bag. ",4/1/2013,"04/01/2013",8/14/2013,"08/14/2013"
"Devices",65689,"Ongoing","Hospira Inc.","Lake Forest","IL","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution - USA (nationwide) and Puerto Rico and Internationally to Costa Rica.","Z-1858-2013","Class I","List No. 14219-28; Y-TYPE BLOOD SET; 200 Micron Filter, Cylinder Pump, CLAVE Y-Site, Non-Vented, 80 Inch, Non-DEHP; For Blood Product Administration; Made in Costa Rica; Product Inquiries should be directed to Hospira., Inc., Lake Forrest, IL 60045 USA Hospira Blood sets are designed for Blood Product Administration","List Number: 14219-28; Lot Number: 962245H",".","3,600 units","It was discovered that there was a potential for the piercing pin on certain Hospira blood sets to puncture the outer wall of blood bags during insertion of the pin into the blood bag. ",4/1/2013,"04/01/2013",8/14/2013,"08/14/2013"
"Devices",65689,"Ongoing","Hospira Inc.","Lake Forest","IL","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution - USA (nationwide) and Puerto Rico and Internationally to Costa Rica.","Z-1856-2013","Class I","List No. 14212-28; PLUM Y-TYPE BLOOD SET; 200 Micron Filter, CLAVE Port, Non-Vented, 110 Inch, Non-DEHP; For Blood Product Administration; Made in Costa Rica; Product Inquiries should be directed to Hospira., Inc., Lake Forrest, IL 60045 USA Hospira Blood sets are designed for Blood Product Administration","List Number: 14212-28; Lot Numbers: 030575H, 081425H, 090515H, 100905H, 100915H, 102255H, 102265H, 122515H, 122525H, 143405H, 143415H, 152655H, 152665H, 152675H, 161375H, 161385H, 161395H, 170955H, 172025H, 172035H, 172045H, 241805H, 250845H, 251735H, 251745H, 962235H",".","692,742 units","It was discovered that there was a potential for the piercing pin on certain Hospira blood sets to puncture the outer wall of blood bags during insertion of the pin into the blood bag. ",4/1/2013,"04/01/2013",8/14/2013,"08/14/2013"
"Devices",65689,"Ongoing","Hospira Inc.","Lake Forest","IL","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution - USA (nationwide) and Puerto Rico and Internationally to Costa Rica.","Z-1855-2013","Class I","List No. 14211-28; PLUM BLOOD SET; Prepierced Port, 200 Micron Filter, 110 Inch, Non-DEHP; For Blood Product Administration; Made in Costa Rica; Product Inquiries should be directed to Hospira., Inc., Lake Forrest, IL 60045 USA Hospira Blood sets are designed for Blood Product Administration","List Number: 14211-28; Lot Numbers: 052945H, 211855H",".","288 units","It was discovered that there was a potential for the piercing pin on certain Hospira blood sets to puncture the outer wall of blood bags during insertion of the pin into the blood bag. ",4/1/2013,"04/01/2013",8/14/2013,"08/14/2013"
"Devices",65691,"Ongoing","Philips Medical Systems (Cleveland) Inc","Cleveland","OH","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution-USA (nationwide) including DC and the states of AL, AR, AZ, CA, CO, DE, FL, GA, IN, KY, MA, MD, MI, MN, MS, NC, NM, NV, NY, OH, OK, PA, SC, TN, TX, VT, WI & WV, and the countries of Australia, Austria, Bosnia & Herzegovina, Chile, China, Croatia, Denmark, Equatorial Guinea, France, Germany, Greenland, Iceland, Indonesia, Israel, Japan, Kazakhstan, Netherlands, Nigeria, Norway, Poland, Romania, South Africa, South Korea, Sweden, Switzerland, Taiwan, United Arab Emirates, United Kingdom & Vietnam.","Z-2210-2013","Class II","Brilliance CT 6, M/N 728256; Brilliance CT 16 M/N 728246; Brilliance CT 40, M/N 728235 & Brilliance CT 64 M/N 728231, Philips Healthcare, Cleveland, OH 44143. Intended to produce cross-sectional images of the body by computer reconstruction. ","Model #, 728231, Serial #: 4021, 9535, 9544, 9587, 9627, 9701, 9707, 9713, 9759, 9875, 9887, 9917, 9925, 9931, 9980, 9996, 10009, 10011, 10012, 10015, 10028, 10036, 10042, 10045, 10050, 10052, 10062, 10063, 10064, 10077, 10079, 10081, 10096, 10099, 10102, 10111, 10114, 10120, 10122, 10135, 10136, 10137, 10139, 10145, 10148, 10149, 10151, 10152, 10153, 10154, 10162, 10165, 10166, 10170, 10171, 10172, 10173, 10188, 10189, 10191, 10196, 10198, 10203, 10214, 10222, 10227, 10228, 10229, 10230, 10235, 10238, 10242, 10243, 10247, 10259, 10260, 10261, 10263, 10268, 10273, 10274, 10278, 10288, 10291, 10293, 10294, 10297, 10298, 10301, 10302, 10307, 10312, 10313, 10316, 10317, 10318, 10319, 10320, 10327, 10336, 10337, 10341, 10347, 10349, 10350, 10351, 10352, 10353, 10362, 10365, 10376, 10380, 10384, 10387, 10393, 10400, 10411, 10412, 10414, 10431, 10438, 10439, 10445, 10446, 10452, 10453, 10459, 10461, 10468, 10470, 10471, 10476, 10482, 10486, 10490, 10491, 10503, 10511, 10513, 10519, 10535, 10536, 10540, 10544, 10546, 10551, 10554, 10561, 10563, 10568, 10569, 10574, 10582, 10600, 10617, 10628, 10631, 10635, 10646, 10647, 10651, 10655, 10659, 10673, 10684, 10686, 10698, 10714, 10733, 10734, 29002, 29014, 29016, 29027, 90054, 90099, 95022, 95046, 95073, 95103, 95107, 95109, 95114, 95132, 95133, 95181, 95209, 95268, 95295, 95305, 95371, 95453, 95473, 95563, 95660, 95704, 95706, 95707, 95712, 95715, 95721, 95727, 95729, 95769, 95778, 90199 & 95162. Model #, 728235, Serial #: 9034, 9190, 9233, 9234, 9261, 29049, 29057, 29064 & 29149. Model #, 728246, Serial #: 3150, 3163, 4051, 5547, 5585, 5623, 5655, 5666, 5670, 5715, 5724, 5747, 5773, 5776, 5791, 5803, 5813, 5836, 5855, 5862, 5868, 5876, 5877, 5897, 5911, 5916, 5935, 5969, 5971, 5974, 5997, 6001, 6006, 6008, 6028, 6087, 6102, 6117, 6120, 6121, 6126, 6170, 6195, 6200, 6202, 6203, 6238, 6243, 6281, 6287, 6306, 6318, 6324, 6346, 6352, 6387, 6402, 6405, 6444, 6484, 6491, 6494, 6495, 6496, 6503, 6517, 6519, 6523, 6556, 6559, 6609, 6610, 6611, 6612, 6623, 6624, 6640, 6642",,"M/N: 728256, 4 units; M/N: 728246, 89 units; M/N: 728235, 9 units & M/N: 728231, 207 units","The patient support may move in an unintended manner if the footswitch cover impinges on the footswitch.",7/5/2013,"07/05/2013",9/25/2013,"09/25/2013"
"Biologics",65692,"Terminated","OneBlood / dba CBCF","Lauderhill","FL","US","Voluntary: Firm Initiated","Letter","Florida; New York","B-2422-13","Class II","Platelets Pooled Leukocytes Reduced","W036810815344; W036810802056; 2927802; 2911416; ",,"4 units","Blood products, collected from an ineligible donor, were distributed. ",6/25/2013,"06/25/2013",11/6/2013,"11/06/2013"
"Biologics",65692,"Terminated","OneBlood / dba CBCF","Lauderhill","FL","US","Voluntary: Firm Initiated","Letter","Florida; New York","B-2417-13","Class II","Red Blood Cells Leukocytes Reduced","W036810061996; ",,"1 unit","Blood products, collected from an ineligible donor, were distributed. ",6/25/2013,"06/25/2013",11/6/2013,"11/06/2013"
"Biologics",65692,"Terminated","OneBlood / dba CBCF","Lauderhill","FL","US","Voluntary: Firm Initiated","Letter","Florida; New York","B-2418-13","Class II","Platelets Pheresis Leukocytes Reduced","W036809202625; ",,"1 unit","Blood products, collected from an ineligible donor, were distributed. ",6/25/2013,"06/25/2013",11/6/2013,"11/06/2013"
"Biologics",65692,"Terminated","OneBlood / dba CBCF","Lauderhill","FL","US","Voluntary: Firm Initiated","Letter","Florida; New York","B-2420-13","Class II","Red Blood Cells","W036810196346; 2547164; 2369454; ",,"3 units","Blood products, collected from an ineligible donor, were distributed. ",6/25/2013,"06/25/2013",11/6/2013,"11/06/2013"
"Biologics",65692,"Terminated","OneBlood / dba CBCF","Lauderhill","FL","US","Voluntary: Firm Initiated","Letter","Florida; New York","B-2421-13","Class II","Cryoprecipitated AHF","2369454; ",,"1 unit","Blood products, collected from an ineligible donor, were distributed. ",6/25/2013,"06/25/2013",11/6/2013,"11/06/2013"
"Biologics",65692,"Terminated","OneBlood / dba CBCF","Lauderhill","FL","US","Voluntary: Firm Initiated","Letter","Florida; New York","B-2419-13","Class II","Fresh Frozen Plasma","W036810196346; W036810061996; W036809202625; 2547164; ",,"4 units","Blood products, collected from an ineligible donor, were distributed. ",6/25/2013,"06/25/2013",11/6/2013,"11/06/2013"
"Biologics",65693,"Terminated","OneBlood / dba CBCF","Lauderhill","FL","US","Voluntary: Firm Initiated","Letter","Florida","B-2385-13","Class II","Fresh Frozen Plasma","W036812560746; ",".","1","Blood products, collected from a donor whose suitability to donate was not adequately determined, were distributed.",6/20/2013,"06/20/2013",11/20/2013,"11/20/2013"
"Biologics",65693,"Terminated","OneBlood / dba CBCF","Lauderhill","FL","US","Voluntary: Firm Initiated","Letter","Florida","B-2384-13","Class II","Red Blood Cells","W036812560746; ",".","1","Blood products, collected from a donor whose suitability to donate was not adequately determined, were distributed.",6/20/2013,"06/20/2013",11/20/2013,"11/20/2013"
"Biologics",65693,"Terminated","OneBlood / dba CBCF","Lauderhill","FL","US","Voluntary: Firm Initiated","Letter","Florida","B-2386-13","Class II","Platelets Pooled Leukocytes Reduced","W036812859472; ",".","1","Blood products, collected from a donor whose suitability to donate was not adequately determined, were distributed.",6/20/2013,"06/20/2013",11/20/2013,"11/20/2013"
"Biologics",65694,"Terminated","Talecris Plasma Resources","Research Triangle Park","NC","US","Voluntary: Firm Initiated","FAX","North Carolina","B-2099-13","Class III","Source Plasma","5090228467; 5090228223; 5090228119; 5090226910; 5090226796; 5090226028; 5090225871; 5090225544; 5090226780; 5090225645; 5090225505; ",,"11","Blood products, collected from donors whose donor suitability was not adequately determined, were distributed.",5/29/2013,"05/29/2013",10/23/2013,"10/23/2013"
"Biologics",65695,"Terminated","Innovative Blood Resources","Saint Paul","MN","US","Voluntary: Firm Initiated","FAX","Minnesota","B-2395-13","Class II","Red Blood Cells Leukocytes Reduced","W051513054232; ",".","1","Blood products, exposed to unacceptable shipping temperatures, were distributed.",6/10/2013,"06/10/2013",11/20/2013,"11/20/2013"
"Biologics",65695,"Terminated","Innovative Blood Resources","Saint Paul","MN","US","Voluntary: Firm Initiated","FAX","Minnesota","B-2397-13","Class II","Red Blood Cells","W051513051659; W051513053101; W051513057298; W051513057299; W051513057300; W051513057301; W051513057303; W051513057315; W051513057316; W051513054782; W051513058923; ",".","11","Blood products, exposed to unacceptable shipping temperatures, were distributed.",6/10/2013,"06/10/2013",11/20/2013,"11/20/2013"
"Biologics",65695,"Terminated","Innovative Blood Resources","Saint Paul","MN","US","Voluntary: Firm Initiated","FAX","Minnesota","B-2396-13","Class II","Red Blood Cells Leukocytes Reduced Irradiated","W051513058139; W051513060745; W051513060748; W051513068170; ",".","4","Blood products, exposed to unacceptable shipping temperatures, were distributed.",6/10/2013,"06/10/2013",11/20/2013,"11/20/2013"
"Biologics",65696,"Terminated","Innovative Blood Resources","Saint Paul","MN","US","Voluntary: Firm Initiated","Letter","Pennsylvania; North Carolina; Wisconsin; Ohio; California; New Jersey; Minnesota; New York","B-2426-13","Class III","Red Blood Cells Leukocytes Reduced","W051511041885; W051512111200; W051512103106; W051513003287; W051512075299; W051511060759; W051511042906; W051511017113; W051511013800; W051512094805; W051512146430; W051512108531; W051512108488; W051512000140; W051512044707; W051512031408; W051511127473; W051511004168; W051511074771; W051511074402; ",".","20","Blood products, collected from donors who were at risk for Leishmaniasis, were distributed.",3/21/2013,"03/21/2013",11/20/2013,"11/20/2013"
"Biologics",65696,"Terminated","Innovative Blood Resources","Saint Paul","MN","US","Voluntary: Firm Initiated","Letter","Pennsylvania; North Carolina; Wisconsin; Ohio; California; New Jersey; Minnesota; New York","B-2423-13","Class III","Red Blood Cells Leukocytes Reduced Irradiated","W051512082767; W051510117188; ",".","2","Blood products, collected from donors who were at risk for Leishmaniasis, were distributed.",3/21/2013,"03/21/2013",11/20/2013,"11/20/2013"
"Biologics",65696,"Terminated","Innovative Blood Resources","Saint Paul","MN","US","Voluntary: Firm Initiated","Letter","Pennsylvania; North Carolina; Wisconsin; Ohio; California; New Jersey; Minnesota; New York","B-2424-13","Class III","Red Blood Cells (Apheresis) Leukocytes Reduced","W051511030045; W051511030045; W051510132288; W051510132288; W051512114636; W051512114636; W051511062344; W051511062344; ",".","8","Blood products, collected from donors who were at risk for Leishmaniasis, were distributed.",3/21/2013,"03/21/2013",11/20/2013,"11/20/2013"
"Biologics",65696,"Terminated","Innovative Blood Resources","Saint Paul","MN","US","Voluntary: Firm Initiated","Letter","Pennsylvania; North Carolina; Wisconsin; Ohio; California; New Jersey; Minnesota; New York","B-2425-13","Class III","Red Blood Cells","W051512104124; W051512009908; W051512103272; W051512096107; W051512051693; W051511053775; ",".","6","Blood products, collected from donors who were at risk for Leishmaniasis, were distributed.",3/21/2013,"03/21/2013",11/20/2013,"11/20/2013"
"Devices",65697,"Ongoing","Atrium Medical Corporation","Hudson","NH","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution - USA (nationwide) and internationally to the following countries: American Samoa Antilles Argentina Australia Austria Bangladesh Belgium Bolivia Brazil Canada Chile Colombia Egypt El Salvador Finland France Germany Great Britain Greece Guatemala Hong Kong India Indonesia Ireland Italy Jamaica Japan Korea Lebanon Libya Malaysia Mauritius Mexico Neal New Zealand Nicaragua Norway Pakistan Panama Peru Philippines Poland Portugal Puerto Rico Romania Russia Saudi Arabia Singapore Slovenia South Africa Spain Switzerland Taiwan Thailand the Netherlands Trinidad Tunisia","Z-2310-2013","Class II","Flixene Grafts >or= 6mm Intended for use in arterial vascular reconstruction, segmental bypass, and for arteriovenous vascular access. ","Product manufactured between April 3, 2012 and May 14, 2013 and can be identified by their expiration date; between April 2017 and May 2018. ",,,"Inner tray label may adhere to wall of outer tray which make it difficult to remove the tray onto the sterile field",7/12/2013,"07/12/2013",10/9/2013,"10/09/2013"
"Devices",65697,"Ongoing","Atrium Medical Corporation","Hudson","NH","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution - USA (nationwide) and internationally to the following countries: American Samoa Antilles Argentina Australia Austria Bangladesh Belgium Bolivia Brazil Canada Chile Colombia Egypt El Salvador Finland France Germany Great Britain Greece Guatemala Hong Kong India Indonesia Ireland Italy Jamaica Japan Korea Lebanon Libya Malaysia Mauritius Mexico Neal New Zealand Nicaragua Norway Pakistan Panama Peru Philippines Poland Portugal Puerto Rico Romania Russia Saudi Arabia Singapore Slovenia South Africa Spain Switzerland Taiwan Thailand the Netherlands Trinidad Tunisia","Z-2316-2013","Class II","Advanta SST Grafts <6mm Intended for use in arterial vascular reconstruction, segmental bypass, and for arteriovenous vascular access. ","Product manufactured between April 3, 2012 and May 14, 2013 and can be identified by their expiration date; between April 2017 and May 2018. ",,,"Inner tray label may adhere to wall of outer tray which make it difficult to remove the tray onto the sterile field",7/12/2013,"07/12/2013",10/9/2013,"10/09/2013"
"Devices",65697,"Ongoing","Atrium Medical Corporation","Hudson","NH","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution - USA (nationwide) and internationally to the following countries: American Samoa Antilles Argentina Australia Austria Bangladesh Belgium Bolivia Brazil Canada Chile Colombia Egypt El Salvador Finland France Germany Great Britain Greece Guatemala Hong Kong India Indonesia Ireland Italy Jamaica Japan Korea Lebanon Libya Malaysia Mauritius Mexico Neal New Zealand Nicaragua Norway Pakistan Panama Peru Philippines Poland Portugal Puerto Rico Romania Russia Saudi Arabia Singapore Slovenia South Africa Spain Switzerland Taiwan Thailand the Netherlands Trinidad Tunisia","Z-2317-2013","Class II","Advanta SST Grafts <6mm Intended for use in arterial vascular reconstruction, segmental bypass, and for arteriovenous vascular access. ","Product manufactured between April 3, 2012 and May 14, 2013 and can be identified by their expiration date; between April 2017 and May 2018. ",,,"Inner tray label may adhere to wall of outer tray which make it difficult to remove the tray onto the sterile field",7/12/2013,"07/12/2013",10/9/2013,"10/09/2013"
"Devices",65697,"Ongoing","Atrium Medical Corporation","Hudson","NH","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution - USA (nationwide) and internationally to the following countries: American Samoa Antilles Argentina Australia Austria Bangladesh Belgium Bolivia Brazil Canada Chile Colombia Egypt El Salvador Finland France Germany Great Britain Greece Guatemala Hong Kong India Indonesia Ireland Italy Jamaica Japan Korea Lebanon Libya Malaysia Mauritius Mexico Neal New Zealand Nicaragua Norway Pakistan Panama Peru Philippines Poland Portugal Puerto Rico Romania Russia Saudi Arabia Singapore Slovenia South Africa Spain Switzerland Taiwan Thailand the Netherlands Trinidad Tunisia","Z-2306-2013","Class II","Advanta SuperSoft Grafts >or= 6mm Intended for use in arterial vascular reconstruction, segmental bypass, and for arteriovenous vascular access. ","Product manufactured between April 3, 2012 and May 14, 2013 and can be identified by their expiration date; between April 2017 and May 2018. ",,,"Inner tray label may adhere to wall of outer tray which make it difficult to remove the tray onto the sterile field",7/12/2013,"07/12/2013",10/9/2013,"10/09/2013"
"Devices",65697,"Ongoing","Atrium Medical Corporation","Hudson","NH","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution - USA (nationwide) and internationally to the following countries: American Samoa Antilles Argentina Australia Austria Bangladesh Belgium Bolivia Brazil Canada Chile Colombia Egypt El Salvador Finland France Germany Great Britain Greece Guatemala Hong Kong India Indonesia Ireland Italy Jamaica Japan Korea Lebanon Libya Malaysia Mauritius Mexico Neal New Zealand Nicaragua Norway Pakistan Panama Peru Philippines Poland Portugal Puerto Rico Romania Russia Saudi Arabia Singapore Slovenia South Africa Spain Switzerland Taiwan Thailand the Netherlands Trinidad Tunisia","Z-2308-2013","Class II","Advanta SST Bifurcated Grafts >or= 6mm Intended for use in arterial vascular reconstruction, segmental bypass, and for arteriovenous vascular access. ","Product manufactured between April 3, 2012 and May 14, 2013 and can be identified by their expiration date; between April 2017 and May 2018. ",,,"Inner tray label may adhere to wall of outer tray which make it difficult to remove the tray onto the sterile field",7/12/2013,"07/12/2013",10/9/2013,"10/09/2013"
"Devices",65697,"Ongoing","Atrium Medical Corporation","Hudson","NH","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution - USA (nationwide) and internationally to the following countries: American Samoa Antilles Argentina Australia Austria Bangladesh Belgium Bolivia Brazil Canada Chile Colombia Egypt El Salvador Finland France Germany Great Britain Greece Guatemala Hong Kong India Indonesia Ireland Italy Jamaica Japan Korea Lebanon Libya Malaysia Mauritius Mexico Neal New Zealand Nicaragua Norway Pakistan Panama Peru Philippines Poland Portugal Puerto Rico Romania Russia Saudi Arabia Singapore Slovenia South Africa Spain Switzerland Taiwan Thailand the Netherlands Trinidad Tunisia","Z-2307-2013","Class II","Flixene IFG with Assisted Delivery Intended for use in arterial vascular reconstruction, segmental bypass, and for arteriovenous vascular access. ","Product manufactured between April 3, 2012 and May 14, 2013 and can be identified by their expiration date; between April 2017 and May 2018. ",,,"Inner tray label may adhere to wall of outer tray which make it difficult to remove the tray onto the sterile field",7/12/2013,"07/12/2013",10/9/2013,"10/09/2013"
"Devices",65697,"Ongoing","Atrium Medical Corporation","Hudson","NH","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution - USA (nationwide) and internationally to the following countries: American Samoa Antilles Argentina Australia Austria Bangladesh Belgium Bolivia Brazil Canada Chile Colombia Egypt El Salvador Finland France Germany Great Britain Greece Guatemala Hong Kong India Indonesia Ireland Italy Jamaica Japan Korea Lebanon Libya Malaysia Mauritius Mexico Neal New Zealand Nicaragua Norway Pakistan Panama Peru Philippines Poland Portugal Puerto Rico Romania Russia Saudi Arabia Singapore Slovenia South Africa Spain Switzerland Taiwan Thailand the Netherlands Trinidad Tunisia","Z-2313-2013","Class II","Advanta VXT Grafts <6mm Intended for use in arterial vascular reconstruction, segmental bypass, and for arteriovenous vascular access. ","Product manufactured between April 3, 2012 and May 14, 2013 and can be identified by their expiration date; between April 2017 and May 2018. ",,,"Inner tray label may adhere to wall of outer tray which make it difficult to remove the tray onto the sterile field",7/12/2013,"07/12/2013",10/9/2013,"10/09/2013"
"Devices",65697,"Ongoing","Atrium Medical Corporation","Hudson","NH","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution - USA (nationwide) and internationally to the following countries: American Samoa Antilles Argentina Australia Austria Bangladesh Belgium Bolivia Brazil Canada Chile Colombia Egypt El Salvador Finland France Germany Great Britain Greece Guatemala Hong Kong India Indonesia Ireland Italy Jamaica Japan Korea Lebanon Libya Malaysia Mauritius Mexico Neal New Zealand Nicaragua Norway Pakistan Panama Peru Philippines Poland Portugal Puerto Rico Romania Russia Saudi Arabia Singapore Slovenia South Africa Spain Switzerland Taiwan Thailand the Netherlands Trinidad Tunisia","Z-2305-2013","Class II","Flixene IFG Vascular Grafts >or= 6mm Intended for use in arterial vascular reconstruction, segmental bypass, and for arteriovenous vascular access. ","Product manufactured between April 3, 2012 and May 14, 2013 and can be identified by their expiration date; between April 2017 and May 2018. ",,,"Inner tray label may adhere to wall of outer tray which make it difficult to remove the tray onto the sterile field",7/12/2013,"07/12/2013",10/9/2013,"10/09/2013"
"Devices",65697,"Ongoing","Atrium Medical Corporation","Hudson","NH","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution - USA (nationwide) and internationally to the following countries: American Samoa Antilles Argentina Australia Austria Bangladesh Belgium Bolivia Brazil Canada Chile Colombia Egypt El Salvador Finland France Germany Great Britain Greece Guatemala Hong Kong India Indonesia Ireland Italy Jamaica Japan Korea Lebanon Libya Malaysia Mauritius Mexico Neal New Zealand Nicaragua Norway Pakistan Panama Peru Philippines Poland Portugal Puerto Rico Romania Russia Saudi Arabia Singapore Slovenia South Africa Spain Switzerland Taiwan Thailand the Netherlands Trinidad Tunisia","Z-2304-2013","Class II","Advanta VXT Vascular Grafts >or= 6mm Intended for use in arterial vascular reconstruction, segmental bypass, and for arteriovenous vascular access. ","Product manufactured between April 3, 2012 and May 14, 2013 and can be identified by their expiration date; between April 2017 and May 2018. ",,,"Inner tray label may adhere to wall of outer tray which make it difficult to remove the tray onto the sterile field",7/12/2013,"07/12/2013",10/9/2013,"10/09/2013"
"Devices",65697,"Ongoing","Atrium Medical Corporation","Hudson","NH","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution - USA (nationwide) and internationally to the following countries: American Samoa Antilles Argentina Australia Austria Bangladesh Belgium Bolivia Brazil Canada Chile Colombia Egypt El Salvador Finland France Germany Great Britain Greece Guatemala Hong Kong India Indonesia Ireland Italy Jamaica Japan Korea Lebanon Libya Malaysia Mauritius Mexico Neal New Zealand Nicaragua Norway Pakistan Panama Peru Philippines Poland Portugal Puerto Rico Romania Russia Saudi Arabia Singapore Slovenia South Africa Spain Switzerland Taiwan Thailand the Netherlands Trinidad Tunisia","Z-2309-2013","Class II","Advanta VS Grafts <6mm Intended for use in arterial vascular reconstruction, segmental bypass, and for arteriovenous vascular access. ","Product manufactured between April 3, 2012 and May 14, 2013 and can be identified by their expiration date; between April 2017 and May 2018. ",,,"Inner tray label may adhere to wall of outer tray which make it difficult to remove the tray onto the sterile field",7/12/2013,"07/12/2013",10/9/2013,"10/09/2013"
"Devices",65697,"Ongoing","Atrium Medical Corporation","Hudson","NH","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution - USA (nationwide) and internationally to the following countries: American Samoa Antilles Argentina Australia Austria Bangladesh Belgium Bolivia Brazil Canada Chile Colombia Egypt El Salvador Finland France Germany Great Britain Greece Guatemala Hong Kong India Indonesia Ireland Italy Jamaica Japan Korea Lebanon Libya Malaysia Mauritius Mexico Neal New Zealand Nicaragua Norway Pakistan Panama Peru Philippines Poland Portugal Puerto Rico Romania Russia Saudi Arabia Singapore Slovenia South Africa Spain Switzerland Taiwan Thailand the Netherlands Trinidad Tunisia","Z-2315-2013","Class II","Advanta VS Grafts >or= 6mm Intended for use in arterial vascular reconstruction, segmental bypass, and for arteriovenous vascular access. ","Product manufactured between April 3, 2012 and May 14, 2013 and can be identified by their expiration date; between April 2017 and May 2018. ",,,"Inner tray label may adhere to wall of outer tray which make it difficult to remove the tray onto the sterile field",7/12/2013,"07/12/2013",10/9/2013,"10/09/2013"
"Devices",65697,"Ongoing","Atrium Medical Corporation","Hudson","NH","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution - USA (nationwide) and internationally to the following countries: American Samoa Antilles Argentina Australia Austria Bangladesh Belgium Bolivia Brazil Canada Chile Colombia Egypt El Salvador Finland France Germany Great Britain Greece Guatemala Hong Kong India Indonesia Ireland Italy Jamaica Japan Korea Lebanon Libya Malaysia Mauritius Mexico Neal New Zealand Nicaragua Norway Pakistan Panama Peru Philippines Poland Portugal Puerto Rico Romania Russia Saudi Arabia Singapore Slovenia South Africa Spain Switzerland Taiwan Thailand the Netherlands Trinidad Tunisia","Z-2314-2013","Class II","Flixene Trumpet Grafts >or= 6mm Flixene GW and GWT Grafts >or= 6mm Intended for use in arterial vascular reconstruction, segmental bypass, and for arteriovenous vascular access. ","Product manufactured between April 3, 2012 and May 14, 2013 and can be identified by their expiration date; between April 2017 and May 2018. ",,,"Inner tray label may adhere to wall of outer tray which make it difficult to remove the tray onto the sterile field",7/12/2013,"07/12/2013",10/9/2013,"10/09/2013"
"Devices",65697,"Ongoing","Atrium Medical Corporation","Hudson","NH","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution - USA (nationwide) and internationally to the following countries: American Samoa Antilles Argentina Australia Austria Bangladesh Belgium Bolivia Brazil Canada Chile Colombia Egypt El Salvador Finland France Germany Great Britain Greece Guatemala Hong Kong India Indonesia Ireland Italy Jamaica Japan Korea Lebanon Libya Malaysia Mauritius Mexico Neal New Zealand Nicaragua Norway Pakistan Panama Peru Philippines Poland Portugal Puerto Rico Romania Russia Saudi Arabia Singapore Slovenia South Africa Spain Switzerland Taiwan Thailand the Netherlands Trinidad Tunisia","Z-2311-2013","Class II","Advanta SST Grafts >or= 6mm Intended for use in arterial vascular reconstruction, segmental bypass, and for arteriovenous vascular access. ","Product manufactured between April 3, 2012 and May 14, 2013 and can be identified by their expiration date; between April 2017 and May 2018. ",,,"Inner tray label may adhere to wall of outer tray which make it difficult to remove the tray onto the sterile field",7/12/2013,"07/12/2013",10/9/2013,"10/09/2013"
"Devices",65697,"Ongoing","Atrium Medical Corporation","Hudson","NH","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution - USA (nationwide) and internationally to the following countries: American Samoa Antilles Argentina Australia Austria Bangladesh Belgium Bolivia Brazil Canada Chile Colombia Egypt El Salvador Finland France Germany Great Britain Greece Guatemala Hong Kong India Indonesia Ireland Italy Jamaica Japan Korea Lebanon Libya Malaysia Mauritius Mexico Neal New Zealand Nicaragua Norway Pakistan Panama Peru Philippines Poland Portugal Puerto Rico Romania Russia Saudi Arabia Singapore Slovenia South Africa Spain Switzerland Taiwan Thailand the Netherlands Trinidad Tunisia","Z-2312-2013","Class II","Advanta SuperSoft Grafts <6mm Intended for use in arterial vascular reconstruction, segmental bypass, and for arteriovenous vascular access. ","Product manufactured between April 3, 2012 and May 14, 2013 and can be identified by their expiration date; between April 2017 and May 2018. ",,,"Inner tray label may adhere to wall of outer tray which make it difficult to remove the tray onto the sterile field",7/12/2013,"07/12/2013",10/9/2013,"10/09/2013"
"Devices",65698,"Ongoing","Atrium Medical Corporation","Hudson","NH","US","Voluntary: Firm Initiated","Letter","USA (nationwide) including Puerto Rico and the countries of Australia Austria Bahrain Brazil Canada Chile Colombia Dominican Republic Ecuador El Salvador France Germany Great Britain Greece Honduras Hong Kong India Ireland Israel Italy Japan Jordan Korea Malaysia Mexico Netherlands New Zealand Nicaragua Norway Panama Peru Portugal Romania Saudi Arabia Singapore South Africa Spain Sri Lanka Switzerland Taiwan Thailand Turkey and Venezuela.","Z-1938-2013","Class II","C-QUR V-Patch Mesh (All sizes and shapes). Intended for use in soft tissue deficiencies. ","Product lines with lot number 10405513 and higher",,"95,286 units","Additional Instructions for Use and Storage Conditions as Coated mesh can adhere to the inner packaging liner due to exposure to high humidity conditions",7/19/2013,"07/19/2013",8/21/2013,"08/21/2013"
"Devices",65698,"Ongoing","Atrium Medical Corporation","Hudson","NH","US","Voluntary: Firm Initiated","Letter","USA (nationwide) including Puerto Rico and the countries of Australia Austria Bahrain Brazil Canada Chile Colombia Dominican Republic Ecuador El Salvador France Germany Great Britain Greece Honduras Hong Kong India Ireland Israel Italy Japan Jordan Korea Malaysia Mexico Netherlands New Zealand Nicaragua Norway Panama Peru Portugal Romania Saudi Arabia Singapore South Africa Spain Sri Lanka Switzerland Taiwan Thailand Turkey and Venezuela.","Z-1939-2013","Class II","C-QUR TacShield Mesh (All sizes and shapes). Intended for use in soft tissue deficiencies.","Product lines with lot number 10405513 and higher",,"15,630 units","Additional Instructions for Use and Storage Conditions as Coated mesh can adhere to the inner packaging liner due to exposure to high humidity conditions",7/19/2013,"07/19/2013",8/21/2013,"08/21/2013"
"Devices",65698,"Ongoing","Atrium Medical Corporation","Hudson","NH","US","Voluntary: Firm Initiated","Letter","USA (nationwide) including Puerto Rico and the countries of Australia Austria Bahrain Brazil Canada Chile Colombia Dominican Republic Ecuador El Salvador France Germany Great Britain Greece Honduras Hong Kong India Ireland Israel Italy Japan Jordan Korea Malaysia Mexico Netherlands New Zealand Nicaragua Norway Panama Peru Portugal Romania Saudi Arabia Singapore South Africa Spain Sri Lanka Switzerland Taiwan Thailand Turkey and Venezuela.","Z-1937-2013","Class II","C-QUR Edge Mesh (All sizes and shapes). Intended for use in soft tissue deficiencies. ","Product lines with lot number 10405513 and higher",,"1501 units","Additional Instructions for Use and Storage Conditions as Coated mesh can adhere to the inner packaging liner due to exposure to high humidity conditions",7/19/2013,"07/19/2013",8/21/2013,"08/21/2013"
"Devices",65698,"Ongoing","Atrium Medical Corporation","Hudson","NH","US","Voluntary: Firm Initiated","Letter","USA (nationwide) including Puerto Rico and the countries of Australia Austria Bahrain Brazil Canada Chile Colombia Dominican Republic Ecuador El Salvador France Germany Great Britain Greece Honduras Hong Kong India Ireland Israel Italy Japan Jordan Korea Malaysia Mexico Netherlands New Zealand Nicaragua Norway Panama Peru Portugal Romania Saudi Arabia Singapore South Africa Spain Sri Lanka Switzerland Taiwan Thailand Turkey and Venezuela.","Z-1936-2013","Class II","C-QUR Mesh (All Sizes, shapes). Intended for use in soft tissue deficiencies.","Product lines with lot number 10405513 and higher",,"32,834 units","Additional Instructions for Use and Storage Conditions as Coated mesh can adhere to the inner packaging liner due to exposure to high humidity conditions",7/19/2013,"07/19/2013",8/21/2013,"08/21/2013"
"Food",65699,"Completed","D'Aqui Manufacturing Products, Corp., Dba Postres de Aqui","Catano","PR","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Puerto Rico only.","F-1849-2013","Class II","Tres Leches cake sold under the following brand names: 1) ''****Tres Leches***Postres D'Aqui***D'Aqui Manufacturing Products Corp***Peso Neto 3oz***''; 2) ''****Tres Leches***Fresh Star***Distribuido por Karelly's Food***PO Box 634 Sabana Seca PR 00952***Peso Neto 3 oz***''","no codes assigned",,"1) 10,125 units; 2) 1,410 units","Undeclared allergens: soy oil",5/18/2013,"05/18/2013",9/4/2013,"09/04/2013"
"Food",65700,"Ongoing","Gasco Industrial","Gurabo","PR","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Puerto Rico only","F-1808-2013","Class II","''***Gasco Golden Egg Yellow Shade Liquid***'' 32 oz plastic bottles & 15 gallon drums","080812, 110912, 051112, 220413",,"528 units","Undeclared allergens: Yellow #5",7/8/2013,"07/08/2013",8/21/2013,"08/21/2013"
"Drugs",65701,"Ongoing","Sanofi US","Bridgewater","NJ","US","Voluntary: Firm Initiated","Letter","Nationwide","D-841-2013","Class II","Rifadin, Rifampin capsules, 150 mg, packaged in 30-count bottle, Rx only, Mfd. for Sanofi-Aventis, U.S., LLC, Bridgewater, NJ 08807, NDC 0068-0510-30","Lot # 3097657, Exp 3/15",".","2,462 bottles","Subpotent drug: low fill volume in some of the capsules",3/7/2013,"03/07/2013",8/14/2013,"08/14/2013"
"Drugs",65702,"Ongoing","Bayer HealthCare Pharmaceuticals Inc.","Wayne","NJ","US","Voluntary: Firm Initiated","Letter","NY, CA","D-807-2013","Class III","Medroxyprogesterone acetate, micronized (EP, USP) active pharmaceutical ingredient, Rx only, packaged in 6.0 kg drums (labeled as 6,000 kg), Bayer Schering Pharma AG, D-13342 Berlin ","Lot 87100040 ",".","194.62 kg","Failed Stability Specifications: Out of specification results for particle size were obtained at the 60 month test point.",6/13/2013,"06/13/2013",7/24/2013,"07/24/2013"
"Devices",65703,"Ongoing","Aesculap, Inc.","Center Valley","PA","US","Voluntary: Firm Initiated","E-Mail","US Distribution including the states of NV and MI","Z-1806-2013","Class II","ProSpace Peek Implant 5 degree x 8.5 x 22 mm The device is intended for vertebral body replacement or intervertebral body fusion to aid in the surgical correction or stabilization of the spine. The Aesculap PEEK Spinal Implant System is indicated for use in the thoracolumbar spine (T1 to L5) for partial or total replacement of a collapsed, damaged, or unstable vertebral body due to tumor or trauma to achieve anterior decompression of the spinal cord and neural tissues, and to restore the height of a collapsed vertebral body. ","Part no. SN038P, batch number 51915765",,"9","Aesculap Implant Systems, LLC initiated a recall of the Aesculap Prospace PEEK 5 degree Implant - 8 x 8.5 x 22 mm (SN038P) because the device is incorrectly etched with an 8 degree lordosis instead of a 5 degree lordosis. The device is labeled correctly, only the etching of the implant may be incorrect. ",6/18/2013,"06/18/2013",7/31/2013,"07/31/2013"
"Food",65704,"Terminated","Pacific Pure Aid","Silverton","OR","US","Voluntary: Firm Initiated","E-Mail","CA, NJ, KY, OH, and IL Foreign - France, Ireland, Australia, England, and Hungry","F-1817-2013","Class II","Fried Onion Powder 44.092 lb carton","Product # DA 10686; Lot # 2171 best-by date June 19, 2013 Lot # 2178 best-by date June 26, 2013 Lot numbers runs for a 24 hour period. The first number is the year; the last three numbers are the Julian date for the day the product was manufactured.",".","477 containers each weighing 44.092 lbs","The product contained gluten and is sold as gluten free.",4/17/2013,"04/17/2013",8/28/2013,"08/28/2013"
"Food",65704,"Terminated","Pacific Pure Aid","Silverton","OR","US","Voluntary: Firm Initiated","E-Mail","CA, NJ, KY, OH, and IL Foreign - France, Ireland, Australia, England, and Hungry","F-1818-2013","Class II","Thai Chili Flake","Product # 68200; Lot # 2179 best-by date June 27, 2013 Lot numbers runs for a 24 hour period. The first number is the year; the last three numbers are the Julian date for the day the product was manufactured.",".","23 containers at 40 lbs each","The product contained gluten and is sold as gluten free.",4/17/2013,"04/17/2013",8/28/2013,"08/28/2013"
"Food",65704,"Terminated","Pacific Pure Aid","Silverton","OR","US","Voluntary: Firm Initiated","E-Mail","CA, NJ, KY, OH, and IL Foreign - France, Ireland, Australia, England, and Hungry","F-1816-2013","Class II","Roasted Red Bell Pepper Plus Powder 50 lb carton","Product # 68237; Lot # 2193 expiration date January 11, 2013 Lot # 2215 expiration date February 2, 2013 Lot numbers runs for a 24 hour period. The first number is the year; the last three numbers are the Julian date for the day the product was manufactured.",".","59 - 50 lb cartons","The product contained gluten and is sold as gluten free.",4/17/2013,"04/17/2013",8/28/2013,"08/28/2013"
"Food",65705,"Ongoing","Olde Thompson, Inc.","Oxnard","CA","US","Voluntary: Firm Initiated","Letter","US states: '' Connecticut '' Delaware '' Florida '' Georgia '' Maine '' Maryland '' Massachusetts '' New Hampshire '' New Jersey '' New York '' North Carolina '' Ohio '' Pennsylvania '' Rhode Island '' Virginia","F-1793-2013","Class I","Earth's Pride Organics: Organic Oregano, 2.2 oz. Packaged at 12 units per case. Packaged in a glass jar with cork closure. Product labeling reads in part:''earth's pride organics PANTRY COLLECTION***ORGANIC OREGANO***NET WT. 2.2 OZ (62.4g)***DISTRIBUTED BY BJWC 25 RESEARCH DRIVE WESTBOROUGH, MA 01581 1-800-934-1204***''.","UPC code: 400000290942 Lot #: 060367, 060692, 061252 and 061864 ",".","11,000 UNITS","Olde Thompson Inc. Oxnard, CA is recalling Earths Pride Organics: Organic Oregano packaged in a 2.2 oz. glass jar with cork closure, Lot #: 060367, 060692, 061252 and 061864 due to possible contamination by Salmonella. ",7/10/2013,"07/10/2013",8/14/2013,"08/14/2013"
"Devices",65706,"Ongoing","Siemens Healthcare Diagnostics, Inc.","Newark","DE","US","Voluntary: Firm Initiated","Letter","USA Nationwide Distribution including the states of: TX, NC, GA, TN, UT, NJ, MI, VA, AR, LA, MO, FL, AZ, CA, DC, PA, NH, WI, SD, SC, NM, MD, and IN.","Z-1924-2013","Class II","Dimension Tacrolimus Flex reagent cartridge (DF107) and Dimension TACR CAL (DC107) Product Usage: The TACR method is an in vitro diagnostic test intended to quantitatively measure Tacrolimus in human whole blood on the Dimension clinical chemistry system. Measurements of Tacrolimus are used as an aid in the management of tacrolimus therapy in kidney and liver transplant patients.","TACR Flex Reagent cartridge, material #10444938, (DF107) lot BB4087 with expiation date 3/28/14 and its linked calibrator, material #10445012, (DC 107) lot 3BD029 with expiration date 03/01/14. ",".","5423","Siemens initiated a recall due to confirmed complaints of low patient sample recovery with Dimension TACR Flex Reagent cartridge (DF107) lot BB4087 and its linked calibrator (DC 107) lot 3BD029. Falsely low Tacrolimus results across the assay range may lead to alterations in dosing. ",7/1/2013,"07/01/2013",8/14/2013,"08/14/2013"
"Biologics",65708,"Terminated","Lions Medical Eye Bank & Research Center of Eastern VA","Norfolk","VA","US","Voluntary: Firm Initiated","Telephone","Oklahoma","B-2251-13","Class III","Cornea","027713ODE01",,"1 cornea","Mislabeled human cornea was distributed. ",7/9/2013,"07/09/2013",10/23/2013,"10/23/2013"
"Biologics",65709,"Terminated","Blood Systems, Inc. dba United Blood Services Texas","El Paso","TX","US","Voluntary: Firm Initiated","FAX","Texas","B-2454-13","Class II","Red Blood Cells (Apheresis) Leukocytes Reduced","W041110029635Q; ",,"1","Blood product, incorrectly determined to be negative for the Fya antigen, was distributed.",6/13/2013,"06/13/2013",10/23/2013,"10/23/2013"
"Biologics",65710,"Terminated","Blood Systems, Inc. dba United Blood Services Texas","El Paso","TX","US","Voluntary: Firm Initiated","FAX","Texas","B-2455-13","Class III","Platelets Pheresis Leukocytes Reduced","W041513016488W; ",".","1","Blood product, labeled with the incorrect platelet count and product volume, was distributed. ",6/4/2013,"06/04/2013",11/20/2013,"11/20/2013"
"Biologics",65711,"Terminated","LifeSouth Community Blood Centers Inc - Birmingham Region","Birmingham","AL","US","Voluntary: Firm Initiated","FAX","Alabama","B-2451-13","Class II","Platelets Pheresis Leukocytes Reduced","W115113138063X; ",".","1","Blood product, with no documentation of monthly QC testing for pH, was distributed. ",5/30/2013,"05/30/2013",11/20/2013,"11/20/2013"
"Biologics",65712,"Terminated","LifeSouth Community Blood Centers, Inc.","Dunwoody","GA","US","Voluntary: Firm Initiated","FAX","Georgia","B-2450-13","Class II","Platelets Pheresis Leukocytes Reduced","W115113151800A; W115113151800A; ",".","2","Blood products, which did not meet QC specifications for platelet pH, were distributed.",5/28/2013,"05/28/2013",11/20/2013,"11/20/2013"
"Biologics",65714,"Terminated","Lifesouth Community Blood Centers - Montgomery Region","Montgomery","AL","US","Voluntary: Firm Initiated","FAX","Alabama","B-2452-13","Class II","Platelets Pheresis","W1151131631751; W1151131631751; W1151131631751; ",".","3","Blood products, with platelet counts below the specified minimum requirement, were distributed.",5/22/2013,"05/22/2013",11/20/2013,"11/20/2013"
"Biologics",65715,"Terminated","Lifesouth Community Blood Centers - Montgomery Region","Montgomery","AL","US","Voluntary: Firm Initiated","FAX","Alabama","B-2453-13","Class II","Platelets Pheresis Leukocytes Reduced","W115113136973Q; W115113136973Q; W115113136973Q; ",".","3","Blood products, with platelet counts below the specified minimum requirement, were distributed.",5/8/2013,"05/08/2013",11/20/2013,"11/20/2013"
"Biologics",65716,"Terminated","Lifesouth Community Blood Centers - Montgomery Region","Montgomery","AL","US","Voluntary: Firm Initiated","FAX","Alabama","B-2399-13","Class II","Platelets Pheresis Leukocytes Reduced","W1151131209912; ",".","1","Blood product, with platelet count below the specified minimum requirement, was distributed.",4/25/2013,"04/25/2013",11/20/2013,"11/20/2013"
"Cosmetics",65717,"Ongoing","Sunflower Hill","Hollis Center","ME","US","Voluntary: Firm Initiated","Other","ME, VA. Product sold only in two LL Bean stores. No online sales.","F-1751-2013","Class II","LL Bean Balsam Pine Moisturizing Lotion, 16 oz plastic bottle with pump. UPC 5DC6550000","Lot Number: 132",,"39 bottles","Mold present in lotion. ",7/11/2013,"07/11/2013",8/7/2013,"08/07/2013"
"Cosmetics",65717,"Ongoing","Sunflower Hill","Hollis Center","ME","US","Voluntary: Firm Initiated","Other","ME, VA. Product sold only in two LL Bean stores. No online sales.","F-1752-2013","Class II","LL Bean Sea Spray Moisturizing Lotion, 16 oz plastic bottle with pump. UPC 5DC6520000","Lot Number: 130",,"26 bottles","Mold present in lotion. ",7/11/2013,"07/11/2013",8/7/2013,"08/07/2013"
"Cosmetics",65717,"Ongoing","Sunflower Hill","Hollis Center","ME","US","Voluntary: Firm Initiated","Other","ME, VA. Product sold only in two LL Bean stores. No online sales.","F-1753-2013","Class II","LL Bean Lemon Verbena Hand and Body Lotion, 16 oz plastic bottle with pump. UPC 5DC6560000, Item Number: 5DC6560","N/A",,"78 Bottles","Mold present in lotion. ",7/11/2013,"07/11/2013",8/7/2013,"08/07/2013"
"Devices",65718,"Ongoing","Sotera Wireless, Inc.","San Diego","CA","US","Voluntary: Firm Initiated","Letter","US distribution including CA and UT.","Z-1818-2013","Class II","ViSi Mobile Chest Sensor (3 lead-wire ECG, AAMI), Catalog No. 93-10014 The ViSi Mobile Monitoring System is intended for use by clinicians and medically qualified personnel for single or multi-parameter vital signs monitoring of adult patients. ","Serial No. ACBE20120900183 ACBE20120900189 ACBE20120900205 ACBE20120900206 ACBE20121000217 ACBE20121000224 ACBE20121000225 ACBE20121000226 ACBE20121000231 ACBE20121000232 ACBE20121000236 ACBE20121000240 ACBE20121000245 ACBE20121000250 ACBE20121000252 ACBE20121000259 ACBE20121000260 ACBE20121000261 ACBE20121000262 ACBE20121000271 ACBE20121100292 ACBE20121100296 ACBE20121100300 ACBE20130200445 ACBE20120900211 ACBE20121000222 ACBE20121000237 ACBE20121000246 ACBE20121000263 ACBE20121100277 ACBE20121100280 ACBE20121100283 ACBE20121100287 ACBE20121100291 ACBE20121100356 ACBE20121100360 ACBE20121100364 ACBE20130100394 ACBE20130100395 ACBE20130100397 ACBE20130100398 ACBE20130100399 ACBE20130100401 ACBE20130100402 ACBE20130100404 ACBE20130100405 ACBE20130100410 ACBE20130100411 ACBE20130100412 ACBE20130100415 ACBE20130100417 ACBE20121000218 ACBE20121000227 ACBE20121000270 ACBE20121100282 ACBE20121100286 ACBE20121100288 ACBE20121100301 ACBE20121100350 ACBE20121100352 ACBE20121100355 ACBE20130100369 ACBE20130100370 ACBE20130100374 ACBE20130100375 ACBE20130100376 ACBE20130100378 ACBE20130100379 ACBE20130100380 ACBE20130100384 ACBE20130100385 ACBE20130100388 ACBE20130100390 ACBE20130100392 ACBE20130100393 ",,"75 units","Sotera Wireless, Inc. is recalling the ViSi Mobile Monitoring System due to the potential for the Chest Sensor to cause a blister wound.",5/23/2013,"05/23/2013",8/7/2013,"08/07/2013"
"Devices",65718,"Ongoing","Sotera Wireless, Inc.","San Diego","CA","US","Voluntary: Firm Initiated","Letter","US distribution including CA and UT.","Z-1817-2013","Class II","ViSi Mobile Monitor, Catalog No. 92-10010 The ViSi Mobile Monitoring System is intended for use by clinicians and medically qualified personnel for single or multi-parameter vital signs monitoring of adult patients. ","Serial No. AAAA20120800519 AAAA20120800520 AAAA20120800526 AAAA20120800527 AAAA20120800533 AAAA20120800537 AAAA20120800538 AAAA20120800539 AAAA20120900544 AAAA20120900548 AAAA20120900557 AAAA20120900562 AAAA20120900564 AAAA20120900577 AAAA20120900578 AAAA20120900580 AAAA20120900584 AAAA20120900587 AAAA20120900591 AAAA20130400890 AAAA20130400896 AAAA20130400902 AAAA20130400909 AAAA20120800501 AAAA20121200604 AAAA20121200606 AAAA20121200609 AAAA20121200610 AAAA20121200611 AAAA20121200615 AAAA20121200617 AAAA20121200618 AAAA20121200620 AAAA20121200621 AAAA20121200624 AAAA20121200626 AAAA20121200628 AAAA20121200629 AAAA20121200630 AAAA20121200632 AAAA20121200636 AAAA20121200639 AAAA20121200640 AAAA20121200645 AAAA20121200647 AAAA20130100680 AAAA20130100684 AAAA20130100688 AAAA20130100689 AAAA20130100691 AAAA20130100692 AAAA20130100693 AAAA20130100694 AAAA20130100698 AAAA20130100699 AAAA20130100700 AAAA20130100701 AAAA20130100703 AAAA20121200605 AAAA20121200612 AAAA20121200613 AAAA20121200622 AAAA20121200625 AAAA20121200627 AAAA20121200633 AAAA20121200642 AAAA20121200643 AAAA20121200646 AAAA20121200648 AAAA20121200649 AAAA20121200650 AAAA20121200651 AAAA20121200652 AAAA20121200653 AAAA20130100654 AAAA20130100655 AAAA20130100656 AAAA20130100657 AAAA20130100658 AAAA20130100660 AAAA20130100661 AAAA20130100662 AAAA20130100664 AAAA20130100665 AAAA20130100666 AAAA20130100669 AAAA20130100670 AAAA20130100671 AAAA20130100672 AAAA20130100678 ",,"90 units","Sotera Wireless, Inc. is recalling the ViSi Mobile Monitoring System due to the potential for the Chest Sensor to cause a blister wound.",5/23/2013,"05/23/2013",8/7/2013,"08/07/2013"
"Devices",65719,"Ongoing","Siemens Medical Solutions USA, Inc","Malvern","PA","US","Voluntary: Firm Initiated","Letter","Nationwide distribution: FL, MA, KS, NY, OH, PA, TX and WI.","Z-1975-2013","Class II","Siemens syngo.plaza SW version VA20 with Mammography license. image processing, radiological system","Model number 10592457, serial numbers 100219, 100201, 100473. Update dated 5/13/13 included the following additional serial numbers: 100177, 100504, 100174, 100181, 100473, and 100539. ",,"6","Siemens issued a Customer Safety Notice to inform customers of a potential problem when using syngo.plaza. In some instances, it can happen that the laterality information in mammography images is not displayed and these images may not be properly aligned to mammography segments. ",3/4/2013,"03/04/2013",8/21/2013,"08/21/2013"
"Food",65720,"Ongoing","High Quality Organics, Inc.","Reno","NV","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","CA, FL, NY","F-1744-2013","Class I","Dried Oregano, cut and sifted; Organic; Product of Turkey, sold in 25 lb boxes High Quality Organics, Reno, NV","LOT OREO-3305638A-CS-102AB",,"3,125 plbs","High Quality Organics was notified by a customer who received a lot of oregano in October 2012, recently tested last box of the shipment and found to be positive for Salmonella.",7/12/2013,"07/12/2013",7/31/2013,"07/31/2013"
"Devices",65721,"Ongoing","Siemens Medical Solutions USA, Inc","Malvern","PA","US","Voluntary: Firm Initiated","Letter","Nationwide distribution: AL, AK, AR, AZ, CA, CO, CT, DC, FL, GA, IA, IL, IN, KY, LA, MA, MD, MN, MO,MS, NC, NE, NH, NJ, NY, OH, PA, PR, SD, TN, TX, UT, VA, WA, and WI.","Z-1945-2013","Class II","Siemens AXIOM Artis zeego x-ray, angiographic system","Model number 10280959",,"132","Siemens issued a customer safety notice about the overlay of system information after a functional check of the brakes on the Artis Zeego system. ",5/13/2013,"05/13/2013",8/21/2013,"08/21/2013"
"Devices",65722,"Ongoing","Sysmex America Inc","Lincolnshire","IL","US","Voluntary: Firm Initiated","Letter","Worldwide distribution: US (Nationwide) including Puerto Rico and states of: AK, AL, AR, CA, CO, CT, FL, GA, IA, IL, IN, KS, KY, LA, MA, MI, MN, MO, MT, NC, ND, NE, NH, NJ, NV, NY, OH, OK, SD, TN, TX, UT, VA, VT, WA, WI, and WY; and country of Canada.","Z-0100-2014","Class II","pocH-100i; sysmex; Automated Hematology Analyzer; 7.3'' x 13.8'' x 18.1'' / 30.8 lbs.; Sysmex Corporation; 1-5-1 Wakinohama-Kaigandori, Chuo-ku, Kobe 651-0073, Japan; Sysmex America, Inc; One Nelson C. White Pkwy, Mundeline, IL 60060, U.S.A. The Sysmex pocH-100i Automated Hematology Analyzer is an automated cell counter intended for in vitro diagnostic use in CLIA non-waived clinical laboratories (not for Point of Care use in a CLIA waived laboratory). The Complete Blood Cel (CBC) count test parameters include: WBC, RBC, HGB, HCT, MCV, MCH, MCHC, RDW-CV, RDW-SD, PLT, MPV, and NEUT%/#, LYMPH %/#, MIXED %/# (EO, BSO, MONO).","Product Code: 023-1861-8; Serial Numbers: B1677 - B1826, F1827 - F2161, F2178 - F2198, F2216 - F2396, F2411 - F2452, F2464 - F2472, F2495 - F2523, F2533, F2550 - F2560, F2592 - F2601, F2614 - F2635, F2640 - F2648, F2662 - F2679, F2710 - F2853, F2855 - F2871, F2878 - F2922, F2945, F2946, F2962 - F2970, F2998 - F3008, F3072 - F3080, F3083 - F3098",".","193 units","The data printed on the thermal printer may omit a digit or decimal point in the results or sample identification number.",5/15/2013,"05/15/2013",10/30/2013,"10/30/2013"
"Devices",65722,"Ongoing","Sysmex America Inc","Lincolnshire","IL","US","Voluntary: Firm Initiated","Letter","Worldwide distribution: US (Nationwide) including Puerto Rico and states of: AK, AL, AR, CA, CO, CT, FL, GA, IA, IL, IN, KS, KY, LA, MA, MI, MN, MO, MT, NC, ND, NE, NH, NJ, NV, NY, OH, OK, SD, TN, TX, UT, VA, VT, WA, WI, and WY; and country of Canada.","Z-0100-2014","Class II","pocH-100i; sysmex; Automated Hematology Analyzer; 7.3'' x 13.8'' x 18.1'' / 30.8 lbs.; Sysmex Corporation; 1-5-1 Wakinohama-Kaigandori, Chuo-ku, Kobe 651-0073, Japan; Sysmex America, Inc; One Nelson C. White Pkwy, Mundeline, IL 60060, U.S.A. The Sysmex pocH-100i Automated Hematology Analyzer is an automated cell counter intended for in vitro diagnostic use in CLIA non-waived clinical laboratories (not for Point of Care use in a CLIA waived laboratory). The Complete Blood Cel (CBC) count test parameters include: WBC, RBC, HGB, HCT, MCV, MCH, MCHC, RDW-CV, RDW-SD, PLT, MPV, and NEUT%/#, LYMPH %/#, MIXED %/# (EO, BSO, MONO).","Product Code: 023-1861-8; Serial Numbers: B1677 - B1826, F1827 - F2161, F2178 - F2198, F2216 - F2396, F2411 - F2452, F2464 - F2472, F2495 - F2523, F2533, F2550 - F2560, F2592 - F2601, F2614 - F2635, F2640 - F2648, F2662 - F2679, F2710 - F2853, F2855 - F2871, F2878 - F2922, F2945, F2946, F2962 - F2970, F2998 - F3008, F3072 - F3080, F3083 - F3098",,"193 units","The data printed on the thermal printer may omit a digit or decimal point in the results or sample identification number.",5/15/2013,"05/15/2013",11/6/2013,"11/06/2013"
"Food",65723,"Completed","Golden Beach Inc","Torrance","CA","US","Voluntary: Firm Initiated","E-Mail","KY, VA, MS, MO, FL, OH, IN, AL, CA,SC,OK","F-1787-2013","Class III","Sunny Sea Sardines in Tomato Sauce, 24 cans/case, 15 oz.","Lot # 10471 November 1, 2015 3700/01173",".","880 cases","Golden Beach Inc. is recalling Sunny Sea Sardines in Tomato Sauce for decomposition.",5/20/2013,"05/20/2013",8/14/2013,"08/14/2013"
"Devices",65724,"Ongoing","Precision Dynamics Corporation","Valencia","CA","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","US Distribution including the states of SC, TX, TN, WA, OK.","Z-1872-2013","Class II","Non-sterile Viscot Surgical Skin Markers Part Number 1437-100 Non-sterile Viscot Part Number 143-100 Surgical Skin Markers are pen-like devices intended to be used to write on the patient's skin, e.g., to outline surgical incision sites or mark anatomical sites for accurate blood pressure measurement; available in nonsterile configuration.","Part Number: PDC PN STERVIS (Viscot PN 1437-100) Lot: 061313.",".","1,200 pens ","PDC Healthcare initiated this recall of Non-Sterile Viscot Part Number 1437-100 Surgical Skin Markers, becuase they were inadvertently mislabeled as PN STER-VIS Sterile Skin Marker Pen with Labels and Flex Ruter.",7/10/2013,"07/10/2013",8/14/2013,"08/14/2013"
"Biologics",65725,"Terminated","Indiana Blood Center","Indianapolis","IN","US","Voluntary: Firm Initiated","FAX","Indiana","B-2511-13","Class II","Red Blood Cells (Apheresis) Leukocytes Reduced","W040713692503; W040713692503; W040713443772; W040713211379; W040713443792; W040713614024; W040713444328; W040713444328; W040713211403; W040713211403; W040713462890; W040713462917; W040713462926; W040713602263; W040713211672; W040713693099; W040713213007; W040713463015; W040713456715; W040713456715; W040713602387; W040713211251; W040713614094; W040713692560; W040713692560; ",".","25","Blood products, with disparate weights between the two units collected during the apheresis procedure, were distributed.",6/25/2013,"06/25/2013",11/20/2013,"11/20/2013"
"Biologics",65726,"Completed","NOVARTIS VACCINES AND DIAGNOSTICS S.r.l","SOVICILLE",,"IT","Voluntary: Firm Initiated","Letter","Multiple U.S. States","B-1832-13","Class II","Meningococcal Polysaccharide Vaccine, Groups A, C, Y, W135 Combined","M12118; ",,"1 Lot","Lot of MENVEO Meningococcal (Groups A, C, Y and W-135) Oligosaccharide Diphtheria CRM-197 Conjugate Vaccine, with higher than specified levels of residual moisture, wwas distributed. ",7/10/2013,"07/10/2013",11/6/2013,"11/06/2013"
"Biologics",65727,"Terminated","The American National Red Cross - Southern Region","Douglasville","GA","US","Voluntary: Firm Initiated","Letter","North Carolina","B-1678-13","Class III","Blood and Blood Products for Reprocessing","03LR08799",,"1 unit","Blood product, collected from an ineligible donor, was distributed. ",6/1/2013,"06/01/2013",11/6/2013,"11/06/2013"
"Biologics",65728,"Terminated","So Ca Permamente Med Group Blood Donor Cntr","Los Angeles","CA","US","Voluntary: Firm Initiated","Telephone","California","B-2510-13","Class II","Red Blood Cells Leukocytes Reduced","W071913002143; ",".","1","Blood product, not appropriately labeled as a low volume unit, was distributed.",6/5/2013,"06/05/2013",11/20/2013,"11/20/2013"
"Food",65729,"Ongoing","Hearthside Food Solutions LLC","Willmar","MN","US","Voluntary: Firm Initiated","Letter","Nationwide, no OUS distribution","F-1733-2013","Class I","Pistachios, Salted in the Shell packaged in the following configurations: 1. Gurley's Golden Recipe Natural Pistachios in 2 oz., 2.25 oz., 12 oz., 3 lb., and 25 lb; 2. Mountain Country Natural Pistachios, in 2. 25 oz., and 3.5 oz.; 3. Rachael's Natural Pistachios in 2 oz.","Best by dates between 02-26-14 to 06-03-14",,"17,538 lbs","One of our vendors, ARO Pistachio Inc., is issuing an FDA Class 2 Voluntary Recall on certain shipments of pistachios.",6/11/2013,"06/11/2013",7/31/2013,"07/31/2013"
"Food",65730,"Ongoing","Aqua Star (USA) Corp.","Seattle","WA","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Products were directly distributed to NJ and MA and further distributed to PA, NJ, and NY.","F-1786-2013","Class II","The master case Bar Code is 20731149654062 and the Retail UPC is 7 31149 65406 8. The Retail Label reads in part ''*** Aqua Star Raw Shrimp Easy-Peel Shell-On*** Ready to Cook *** Net Wt 1 lb (454g) ***''","Date Code SGE-12/282 and Retail UPC 7 31149 65406 8. ",".","131 cases/20 packages/1 lbs.","Aqua Star Raw Frozen Shrimp Easy-Peel Shell-On, Ready to Cook, 1 lb. plastic bags, date code SGE-12/282 was recalled due to Salmonella. ",7/11/2013,"07/11/2013",8/14/2013,"08/14/2013"
"Drugs",65731,"Ongoing","Hospira Inc.","Lake Forest","IL","US","Voluntary: Firm Initiated","Letter","Nationwide and Guam","D-813-2013","Class II","Sodium Chloride Injection, USP, 0.9%, 20 mL Single-dose Fliptop Plastic Vial, packaged in 25 vial Units per carton, Rx only, Hospira, Inc., Lake Forest, IL 60045 USA, NDC 0409-4888-20.","Lot #: 15-058-DK*, Exp 1MAR2014; note the * may be followed by 01",,"268,700 vials","Presence of Particulate Matter: Confirmed customer report of visible particulate in the form of an orange or rust colored ring embedded in between the plastic layers of the plastic vial.",6/27/2013,"06/27/2013",7/31/2013,"07/31/2013"
"Devices",65732,"Ongoing","Medtronic Inc. Cardiac Rhythm Disease Management","Saint Paul","MN","US","Voluntary: Firm Initiated","Telephone","Worldwide Distribution - US Distribution only to MS and IL, and the countries of Argentina and Singapore.","Z-1966-2013","Class II","Medtronic Affinity Pediatric Arterial Filter, model number S4014, sterilized using ethylene oxide. The Affinity Pediatric Arterial Filters are single-use, sterile, nonpyrogenic devices designed to filter microemboli greater than the specified micron size from the circuit for periods up to 6 hours during cardiopulmonary bypass surgery. These devices are available both in an uncoated and a Carmeda coated option. The Carmeda coating is a BioActive surface that is non-leaching and provides a thromboresistant blood contact surface. ","Lot Numbers: 12635577 and 12637041",,"148 devices","Medtronic is recalling 148 Affinity Pediatric Arterial Filters from 2 manufacturing lots because a limited quantity of filters may have a small breach in the filter media that may allow unwanted particulate or gaseous emboli to pass through the filter and the outlet of the device, which could result in serious injury to a pediatric patient including neurological damage, or potential patient death.",6/14/2013,"06/14/2013",8/21/2013,"08/21/2013"
"Devices",65734,"Completed","Remel Inc","Lenexa","KS","US","Voluntary: Firm Initiated","Letter","Nationwide Distribution including AL, CA, CO, FL, IA, KS, LA, MA, MS, NE, NH, NJ, NY, OK, OR, RI, TN, TX, VA, WA WI, and Puerto Rico.","Z-0528-2014","Class III","Oxoid Antimicrobial Susceptibility Test Discs, CTO425B Ciprofloxacin CIP 5 mcg, 50 discs per cartridge, 5 cartridges per box. The firm name on the box label is Oxoid Ltd., Basingstoke, UK. Used in the semi-quantitative agar diffusion test method for in vitro susceptibility testing to assist in the determination of a suitable antibiotic agent for treatment purposes.","Lot number: 1220205, exp July 21, 2015",".","60/5/50-disc cartridge boxes","Boxes labeled as CIP5 may contain cartridges of AMP5.",11/21/2012,"11/21/2012",12/26/2013,"12/26/2013"
"Food",65736,"Ongoing","Hagee Foods Inc.","Auburn","WA","US","Voluntary: Firm Initiated","Telephone","Products were directly distributed in Oregon and Washington.","F-1775-2013","Class I","Penny's Black Bean Hummus 12 oz has UPC 7 49404 70200 3; Harbor Greens Black Bean Hummus 8 oz has UPC 7 49404 80515 5; Tacoma Boys Black Bean Hummus 8 oz has UPC 7 49404 90515 2.","USE BY dates 7/13/2013 - 8/25/2013.",,"138/12 oz packages; 270/8 oz packages","Black Bean Hummus is recalled due to a potential contamination with Listeria monocytogenes.",7/13/2013,"07/13/2013",8/7/2013,"08/07/2013"
"Food",65736,"Ongoing","Hagee Foods Inc.","Auburn","WA","US","Voluntary: Firm Initiated","Telephone","Products were directly distributed in Oregon and Washington.","F-1772-2013","Class I","Penny's Hummus De Gallo 12 oz has UPC 7 49404 32368 0; Harbor Greens Hummus De Gallo 8 oz has UPC 7 49404 8061609; Tacoma Boys Hummus De Gallo 8 oz has UPC 7 49404 90676 6.","USE BY dates 7/13/2013 - 8/25/2013.",,"1080/12 oz. packages and 324/ 8 oz packages","Hummus De Gallo is recalled due to a potential contamination with Listeria monocytogenes.",7/13/2013,"07/13/2013",8/7/2013,"08/07/2013"
"Food",65736,"Ongoing","Hagee Foods Inc.","Auburn","WA","US","Voluntary: Firm Initiated","Telephone","Products were directly distributed in Oregon and Washington.","F-1770-2013","Class I","Penny's Garlic Hummus 12 oz has UPC 7 49404 83061 4; Harbor Greens Garlic Hummus 8 oz has UPC 7 49404 802123; Tacoma Boys Garlic Hummus 8 oz has UPC 7 49404 902120; The 1 Gallon hummus does not have any brand name and does not have any UPC.","USE BY dates 7/13/2013 - 8/25/2013.",,"486/8 oz packages; 1338/12 oz packages; and 12/1 gallon containers","Garlic Hummus is recalled due to a potential contamination with Listeria monocytogenes. ",7/13/2013,"07/13/2013",8/7/2013,"08/07/2013"
"Food",65736,"Ongoing","Hagee Foods Inc.","Auburn","WA","US","Voluntary: Firm Initiated","Telephone","Products were directly distributed in Oregon and Washington.","F-1773-2013","Class I","Penny's Roasted Red Pepper Hummus 12 oz has UPC 7 49404 51848 2; Harbor Greens Roasted Red Pepper Hummus 8 oz has UPC 7 49404 80414 1; Tacoma Boys Roasted Red Pepper Hummus 8 oz has UPC 7 49404 90414 8; Roasted Red Pepper Hummus (no brand name) 1 gallon has No UPC.","USE BY dates 7/13/2013 - 8/25/2013.",,"10/1 gallon containers; 396/8 oz packages; 1014/12 oz packages","Roasted Red Pepper Hummus is recalled due to a potential contamination with Listeria monocytogenes.",7/13/2013,"07/13/2013",8/7/2013,"08/07/2013"
"Food",65736,"Ongoing","Hagee Foods Inc.","Auburn","WA","US","Voluntary: Firm Initiated","Telephone","Products were directly distributed in Oregon and Washington.","F-1778-2013","Class I","Vegetable tray 8 oz UPC 7 49404 30002 5; Ingredients: Carrot Sticks, Pretzels, Grapes, Creamy Hummus. Penny's Salsa Inc. Snack Pack w/Hummus Grapes, Carrots and Pretzels 8 oz UPC 07494041923679. Both of these products contain the same ingredients in the same amount. Each contains a 1.5 oz package of hummus labeled Made in the Pacific North West. ","USE BY dates 7/13/2013 - 7/24/2013.",,"245/8 oz packages","Vegetable Trays and Snack Pack, 8 oz, are recalled because they contain 1.5 oz cups of hummus. The hummus is recalled due to a potential contamination with Listeria monocytogenes.",7/13/2013,"07/13/2013",8/7/2013,"08/07/2013"
"Food",65736,"Ongoing","Hagee Foods Inc.","Auburn","WA","US","Voluntary: Firm Initiated","Telephone","Products were directly distributed in Oregon and Washington.","F-1777-2013","Class I","Vegetable tray 8 oz UPC 7 49404 98020 3; Ingredients: Carrot Sticks, Celery, Grape Tomatoes, Creamy Hummus. Penny's Salsa Inc. Snack Pack 8 oz has UPC 07494041923606. Ingredient: W/Hummus, Celery, Carrots, Tomato. Both of these products contain the same ingredients in the same amount. The hummus is in a 1.5 oz container, labeled Made in the Pacific North West.","USE BY dates 7/13/2013 - 7/24/2013.",,"946/ 8 oz packages","Vegetable Trays and Snack Pack, 8 oz, are recalled because they contain 1.5 oz cups of hummus. The hummus is recalled due to a potential contamination with Listeria monocytogenes.",7/13/2013,"07/13/2013",8/7/2013,"08/07/2013"
"Food",65736,"Ongoing","Hagee Foods Inc.","Auburn","WA","US","Voluntary: Firm Initiated","Telephone","Products were directly distributed in Oregon and Washington.","F-1774-2013","Class I","Penny's Jalapeno Hummus 12 oz UPC 7 49404 91368 3; Harbor Greens Jalapeno Hummus 8 oz UPC 7 49404 80313 7; Tacoma Boys Jalapeno Hummus 8 oz UPC 7 49404 90313 4.","USE BY dates 7/13/2013 - 8/25/2013.",,"444/12 oz packages and 369/8 oz packages","Jalapeno Hummus is recalled due to a potential contamination with Listeria monocytogenes.",7/13/2013,"07/13/2013",8/7/2013,"08/07/2013"
"Food",65736,"Ongoing","Hagee Foods Inc.","Auburn","WA","US","Voluntary: Firm Initiated","Telephone","Products were directly distributed in Oregon and Washington.","F-1776-2013","Class I","Harbor Greens Sun-Dried Tomato Hummus 8 oz has UPC 7 49404 80717 3; Tacoma Boys Sun-Dried Tomato Hummus 8 oz has UPC 7 49404 90717 0.","USE BY dates 7/13/2013 - 8/25/2013.",,"162/8 oz packages","Sun-Dried Tomatoes Hummus is recalled due to a potential contamination with Listeria monocytogenes.",7/13/2013,"07/13/2013",8/7/2013,"08/07/2013"
"Food",65736,"Ongoing","Hagee Foods Inc.","Auburn","WA","US","Voluntary: Firm Initiated","Telephone","Products were directly distributed in Oregon and Washington.","F-1771-2013","Class I","PENNY'S CREAMY HUMMUS 12 oz has UPC 7 49404 90971 6; PENNY'S SALSA Creamy Original Hummus 25 LB has no UPC.","USE BY dates 7/13/2013 - 8/25/2013.",,"864/12 oz packages and 16/25 lb containers","Creamy Hummus is recalled due to a potential contamination with Listeria monocytogenes.",7/13/2013,"07/13/2013",8/7/2013,"08/07/2013"
"Food",65737,"Ongoing","Whole Foods Market Mid-Atlantic Kitchen","Landover","MD","US","Voluntary: Firm Initiated","E-Mail","The product was distributed to Kentucky, Maryland, Pennsylvania, Ohio, Virginia, Washington D.C. and New Jersey.","F-1746-2013","Class I","Pimento Cheese, packaged in 7 oz. plastic containers, and labeled in part ***Made by Whole Foods Market, Landover, MD 20785***UPC: 000000234801 ","Use by 07/29/13 ",,"624 units","Pimento cheese was mislabeled with an ingredient list, which did not declare the presence of mayonnaise, containing egg sub-ingredient.",7/16/2013,"07/16/2013",8/7/2013,"08/07/2013"
"Devices",65738,"Ongoing","Smith & Nephew Inc","Memphis","TN","US","Voluntary: Firm Initiated","E-Mail","International only: Germany, France, United Arab Emirates, and United Kingdom.","Z-1996-2013","Class II","GENESIS(R) II CRUCIATE RETAINING ARTICULAR INSERT, TRIAL, SIZE 3-4, A/P 48 MM, M/L 68 MM, QTY 1, NON-STERILE, REF 71430490, Product Usage: Orthopedic ","Lot Number 12LM03798",".","9 units","The products were produced using the wrong color material, resulting in the devices being red (used for deep dished inserts) instead of blue (used for cruciate retaining inserts). ",7/8/2013,"07/08/2013",8/28/2013,"08/28/2013"
"Devices",65739,"Ongoing","Fresenius Medical Care Holdings, Inc.","Waltham","MA","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution-USA (nationwide) and the country of Canada.","Z-0185-2014","Class II","Combiset Blood Line with BVM for Hemodialysis use Catalog Number: 03-2965-9. Intended for use as the extracorporeal blood circuit during Hemodialysis and is indicated for use with conventional and high flux negative pressure hemodialyzer equipment.","All lot codes",".","24,202 cases","Updated Instructions for Use: Bloodline connections not tightened per instructions in the operator's manual may disconnect and lead to blood loss ",8/29/2013,"08/29/2013",11/20/2013,"11/20/2013"
"Devices",65739,"Ongoing","Fresenius Medical Care Holdings, Inc.","Waltham","MA","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution-USA (nationwide) and the country of Canada.","Z-0184-2014","Class II","2008K@ Home Blood lines Combiset True Flow Series for Hemodialysis use Catalog Number: 03-2962-3. Intended for use as the extracorporeal blood circuit during Hemodialysis and is indicated for use with conventional and high flux negative pressure hemodialyzer equipment.","All lot codes",".","8,528 cases","Updated Instructions for Use: Bloodline connections not tightened per instructions in the operator's manual may disconnect and lead to blood loss ",8/29/2013,"08/29/2013",11/20/2013,"11/20/2013"
"Devices",65739,"Ongoing","Fresenius Medical Care Holdings, Inc.","Waltham","MA","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution-USA (nationwide) and the country of Canada.","Z-0186-2014","Class II","Combiset Blood Line Hemodialysis use Catalog Number: 03-2622-3. Intended for use as the extracorporeal blood circuit during Hemodialysis and is indicated for use with conventional and high flux negative pressure hemodialyzer equipment.","All lot codes",".","508,029 cases","Updated Instructions for Use: Bloodline connections not tightened per instructions in the operator's manual may disconnect and lead to blood loss ",8/29/2013,"08/29/2013",11/20/2013,"11/20/2013"
"Food",65740,"Ongoing","Zip International Group LLC.","Edison","NJ","US","Voluntary: Firm Initiated","Letter","IN, ND & NY","F-1813-2013","Class II","Marmalade Fonariky Net 105.8 oz (3 kg) Product of Russia upc 460161417406","Net Wt. 105.8 oz.product code SS Lot number 24",".","15 cartons","Marmalade contains undeclared colors and dyes.",5/17/2013,"05/17/2013",8/28/2013,"08/28/2013"
"Devices",65742,"Ongoing","Integra LifeSciences Corp.","Plainsboro","NJ","US","Voluntary: Firm Initiated","Letter","Worldwide distribution: US (nationwide) and countries of: AR, BR, CH, CL,CR. DE, ES, FI, FR, GB, IL, IT, MX, PA, PL, PT, RU, TW, and ZA.","Z-0056-2014","Class II","Integra Licox Brain Tissue Oxygen Monitoring 1 x Complete Brain Probe Kit REF IP2.P Rx Only, Manufacturer GMS- Gesellschaft fur medizinische, Sondentechnik mbH Dofstrasse 2 24247 Melkendorf, Germany Distributed by Integra Neurosciences 311 Enterprise Drive Plainsboro, NJ 08536 USA Used in direct monitoring of the partial pressure of oxygen. ","K040235 Lot #020812l 050712; 070612; 090812; 140612;173419; 173438; 173515; 173538; 173540; 173720; 173725; 173887; 173918; 190712; 210612; 230812; 260712",".","503 kits(482 US; 21 non US)","Integra LifeSciences Corporation has determined that there is a possibility that some lots of Licox CMP Brain Tissue Oxygen and Temperature Catheter Kits contain a hex wrench that does not loosen the set screw on the drill bit.",6/11/2013,"06/11/2013",10/30/2013,"10/30/2013"
"Devices",65742,"Ongoing","Integra LifeSciences Corp.","Plainsboro","NJ","US","Voluntary: Firm Initiated","Letter","Worldwide distribution: US (nationwide) and countries of: AR, BR, CH, CL,CR. DE, ES, FI, FR, GB, IL, IT, MX, PA, PL, PT, RU, TW, and ZA.","Z-0054-2014","Class II","Integra Licox Brain Tissue Oxygen Monitoring; 1 x Complete Brain Probe Kit REF IP1.P Rx Only, Manufacturer GMS- Gesellschaft fur medizinische, Sondentechnik mbH Dofstrasse 2 24247 Melkendorf, Germany Distributed by Integra Neurosciences 311 Enterprise Drive Plainsboro, NJ 08536 USA. Used in direct monitoring of the partial pressure of oxygen. ","K040235 Lot 160812",".","21 kits","Integra LifeSciences Corporation has determined that there is a possibility that some lots of Licox CMP Brain Tissue Oxygen and Temperature Catheter Kits contain a hex wrench that does not loosen the set screw on the drill bit.",6/11/2013,"06/11/2013",10/30/2013,"10/30/2013"
"Devices",65742,"Ongoing","Integra LifeSciences Corp.","Plainsboro","NJ","US","Voluntary: Firm Initiated","Letter","Worldwide distribution: US (nationwide) and countries of: AR, BR, CH, CL,CR. DE, ES, FI, FR, GB, IL, IT, MX, PA, PL, PT, RU, TW, and ZA.","Z-0062-2014","Class II","Integra Licox Brain Tissue Oxygen Monitoring 1 x Complete Brain Probe Kit REF IM3.S_.EU Rx Only, Manufacturer GMS- Gesellschaft fur medizinische, Sondentechnik mbH Dofstrasse 2 24247 Melkendorf, Germany Distributed by Integra Neurosciences 311 Enterprise Drive Plainsboro, NJ 08536 USA Used in direct monitoring of the partial pressure of oxygen. ","Lot #170812",".","6 non US kits","Integra LifeSciences Corporation has determined that there is a possibility that some lots of Licox CMP Brain Tissue Oxygen and Temperature Catheter Kits contain a hex wrench that does not loosen the set screw on the drill bit.",6/11/2013,"06/11/2013",10/30/2013,"10/30/2013"
"Devices",65742,"Ongoing","Integra LifeSciences Corp.","Plainsboro","NJ","US","Voluntary: Firm Initiated","Letter","Worldwide distribution: US (nationwide) and countries of: AR, BR, CH, CL,CR. DE, ES, FI, FR, GB, IL, IT, MX, PA, PL, PT, RU, TW, and ZA.","Z-0063-2014","Class II","Integra Licox Brain Tissue Oxygen Monitoring 1 x Complete Brain Probe Kit REF IM3.ST_.EU Rx Only, Manufacturer GMS- Gesellschaft fur medizinische, Sondentechnik mbH Dofstrasse 2 24247 Melkendorf, Germany Distributed by Integra Neurosciences 311 Enterprise Drive Plainsboro, NJ 08536 USA Used in direct monitoring of the partial pressure of oxygen. ","Lot #060712, 170812",".","34 non US kits","Integra LifeSciences Corporation has determined that there is a possibility that some lots of Licox CMP Brain Tissue Oxygen and Temperature Catheter Kits contain a hex wrench that does not loosen the set screw on the drill bit.",6/11/2013,"06/11/2013",10/30/2013,"10/30/2013"
"Devices",65742,"Ongoing","Integra LifeSciences Corp.","Plainsboro","NJ","US","Voluntary: Firm Initiated","Letter","Worldwide distribution: US (nationwide) and countries of: AR, BR, CH, CL,CR. DE, ES, FI, FR, GB, IL, IT, MX, PA, PL, PT, RU, TW, and ZA.","Z-0061-2014","Class II","Integra Licox Brain Tissue Oxygen Monitoring 1 x Dual Lumen Introducer Kit REF IM2.S_.EU Rx Only, Manufacturer GMS- Gesellschaft fur medizinische, Sondentechnik mbH Dofstrasse 2 24247 Melkendorf, Germany Distributed by Integra Neurosciences 311 Enterprise Drive Plainsboro, NJ 08536 USA Used in direct monitoring of the partial pressure of oxygen. ","Lot # 030912, 110612, 170812, 230812",".","695 units (US and Foreign)","Integra LifeSciences Corporation has determined that there is a possibility that some lots of Licox CMP Brain Tissue Oxygen and Temperature Catheter Kits contain a hex wrench that does not loosen the set screw on the drill bit.",6/11/2013,"06/11/2013",10/30/2013,"10/30/2013"
"Devices",65742,"Ongoing","Integra LifeSciences Corp.","Plainsboro","NJ","US","Voluntary: Firm Initiated","Letter","Worldwide distribution: US (nationwide) and countries of: AR, BR, CH, CL,CR. DE, ES, FI, FR, GB, IL, IT, MX, PA, PL, PT, RU, TW, and ZA.","Z-0060-2014","Class II","Integra Licox Brain Tissue Oxygen Monitoring 1 x Dual Lumen Introducer Kit REF IM2_EU Rx Only, Manufacturer GMS- Gesellschaft fur medizinische, Sondentechnik mbH Dofstrasse 2 24247 Melkendorf, Germany Distributed by Integra Neurosciences 311 Enterprise Drive Plainsboro, NJ 08536 USA Used in direct monitoring of the partial pressure of oxygen. ","Lot # 010612, 140512, 140612",".","42 Kits non US","Integra LifeSciences Corporation has determined that there is a possibility that some lots of Licox CMP Brain Tissue Oxygen and Temperature Catheter Kits contain a hex wrench that does not loosen the set screw on the drill bit.",6/11/2013,"06/11/2013",10/30/2013,"10/30/2013"
"Devices",65742,"Ongoing","Integra LifeSciences Corp.","Plainsboro","NJ","US","Voluntary: Firm Initiated","Letter","Worldwide distribution: US (nationwide) and countries of: AR, BR, CH, CL,CR. DE, ES, FI, FR, GB, IL, IT, MX, PA, PL, PT, RU, TW, and ZA.","Z-0058-2014","Class II","Integra Licox Brain Tissue Oxygen Monitoring 1 x Complete Brain Probe Kit REF IM3.SR Rx Only, Manufacturer GMS- Gesellschaft fur medizinische, Sondentechnik mbH Dofstrasse 2 24247 Melkendorf, Germany Distributed by Integra Neurosciences 311 Enterprise Drive Plainsboro, NJ 08536 USA Used in direct monitoring of the partial pressure of oxygen. ","K002765 Lot # 130712, 210912, 220612, 172281, 172647, 172690, 173170, 173260, 173548, 173580, 173917, 173942",".","175 KITS","Integra LifeSciences Corporation has determined that there is a possibility that some lots of Licox CMP Brain Tissue Oxygen and Temperature Catheter Kits contain a hex wrench that does not loosen the set screw on the drill bit.",6/11/2013,"06/11/2013",10/30/2013,"10/30/2013"
"Devices",65742,"Ongoing","Integra LifeSciences Corp.","Plainsboro","NJ","US","Voluntary: Firm Initiated","Letter","Worldwide distribution: US (nationwide) and countries of: AR, BR, CH, CL,CR. DE, ES, FI, FR, GB, IL, IT, MX, PA, PL, PT, RU, TW, and ZA.","Z-0057-2014","Class II","Inegra Licox Brain Tissue Oxygen Monitoring 1 x Complete Brain Tunneling Probe Kit REF IT2 Rx Only, Manufacturer GMS- Gesellschaft fur medizinische, Sondentechnik mbH Dofstrasse 2 24247 Melkendorf, Germany Distributed by Integra Neurosciences 311 Enterprise Drive Plainsboro, NJ 08536 USA Used in direct monitoring of the partial pressure of oxygen. ","K040244 Lot #190712; 240512;280612",".","109 kits","Integra LifeSciences Corporation has determined that there is a possibility that some lots of Licox CMP Brain Tissue Oxygen and Temperature Catheter Kits contain a hex wrench that does not loosen the set screw on the drill bit.",6/11/2013,"06/11/2013",10/30/2013,"10/30/2013"
"Devices",65742,"Ongoing","Integra LifeSciences Corp.","Plainsboro","NJ","US","Voluntary: Firm Initiated","Letter","Worldwide distribution: US (nationwide) and countries of: AR, BR, CH, CL,CR. DE, ES, FI, FR, GB, IL, IT, MX, PA, PL, PT, RU, TW, and ZA.","Z-0059-2014","Class II","Integra Licox Brain Tissue Oxygen Monitoring 1 x Complete Brain Probe Kit REF IM1.S Rx Only, Manufacturer GMS- Gesellschaft fur medizinische, Sondentechnik mbH Dofstrasse 2 24247 Melkendorf, Germany Distributed by Integra Neurosciences 311 Enterprise Drive Plainsboro, NJ 08536 USA Used in direct monitoring of the partial pressure of oxygen. ","K002765 Lot # 090812, 170812",".","16 KITS","Integra LifeSciences Corporation has determined that there is a possibility that some lots of Licox CMP Brain Tissue Oxygen and Temperature Catheter Kits contain a hex wrench that does not loosen the set screw on the drill bit.",6/11/2013,"06/11/2013",10/30/2013,"10/30/2013"
"Devices",65742,"Ongoing","Integra LifeSciences Corp.","Plainsboro","NJ","US","Voluntary: Firm Initiated","Letter","Worldwide distribution: US (nationwide) and countries of: AR, BR, CH, CL,CR. DE, ES, FI, FR, GB, IL, IT, MX, PA, PL, PT, RU, TW, and ZA.","Z-0055-2014","Class II","Integra Licox Brain Tissue Oxygen Monitoring; 1 x Dual Lumen Introducer Kit REF IP2; Rx Only, Manufacturer GMS- Gesellschaft fur medizinische, Sondentechnik mbH Dofstrasse 2 24247 Melkendorf, Germany Distributed by Integra Neurosciences 311 Enterprise Drive Plainsboro, NJ 08536 USA. Used in direct monitoring of the partial pressure of oxygen. ","K040235 Lot #020712;040912;050712;080612;110912;120912;140612;290812",".","62 kits (31 US; 31 non US)","Integra LifeSciences Corporation has determined that there is a possibility that some lots of Licox CMP Brain Tissue Oxygen and Temperature Catheter Kits contain a hex wrench that does not loosen the set screw on the drill bit.",6/11/2013,"06/11/2013",10/30/2013,"10/30/2013"
"Devices",65743,"Ongoing","Medtronic Navigation, Inc.","Louisville","CO","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution.","Z-1956-2013","Class II","StealthStation S7 Framelink Software version 5.4. Aid for locating anatomical structures and planning surgical trajectories in open and percutaneous procedures.","Lot number(s): Not applicable; All kits containing the Framelink Software version 5.4 are affected by this corrective action.",,"572","Medtronic Navigation, Inc. has initiated a field correction to their Framelink software version 5.4 which can be used on Medtronic Navigation StealthStation 57 and i7 systems or a Medtronic Planning Station due to the potential of discrepancy between the exam image and the displayed measurement or overlay under certain conditions of use. ",7/15/2013,"07/15/2013",8/21/2013,"08/21/2013"
"Devices",65744,"Ongoing","Edwards Lifesciences, LLC","Draper","UT","US","Voluntary: Firm Initiated","Letter","US Nationwide including Canada and VA sites.","Z-1972-2013","Class II","Edwards EndoReturn Arterial Cannula, model ER21B and ER23B Product Usage: The ThruPort EndoReturn arterial cannula kit (with or without hemostasis valve), an introducer, a guidewire,and a connector hub. The ThruPort catheter introducer sheath kit includes a wire reinforced cannula with hemostasis valve, an introducer, and a guidewire. The cannulae have a wire reinforced section to provide kink resistance and flexibility, tapered tips to aid in insertion and advancement into the femoral artery, a non-reinforced clamp site, a 3/8 in. (9.5 mm) barbed connector, and a hemostasis valve (available on some versions) that allows passage of catheters, such as the EndoClamp aortic catheter. The introducers accept a .038 in. (0.97 mm) guidewire and are marked to simplify assembly and indicate alignment. On some versions, a connector hub secures and immobilizes the introducer within the cannula for easier, one person insertion of the cannula/introducer assembly. ","Model ER21B Lots: 59496984, 59516933, 59516936, 59531385, 59531386 , 59543708 Model ER23B Lots: 59464327, 59484349, 59484350, 59484351, 59512146, 59513272, 59516940, 59534430, 59535739, 59541763 ",,"855","Edwards Lifesciences is recalling certain lots of the EndoReturn Arterial Cannula that were built with an incorrect component. This component can create a performance problem with the IntraClude IntraAortic Occlusion device.",7/16/2013,"07/16/2013",8/21/2013,"08/21/2013"
"Devices",65745,"Ongoing","Aspen Surgical Products, Inc.","Caledonia","MI","US","Voluntary: Firm Initiated","Telephone","Worldwide Distribution - US Nationwide in the state of Florida and in the countries of , Netherlands, and Reditch Worcestershire England","Z-1988-2013","Class II","Distributed in USA: Product Number: 40-2894: Reinforced Wound Closure, Latex Free Sterile EO Rx, 1/4'' X 4 '', 6 mm X100 mm, (2 Cards/pouch, 1,000 Pouches/box); Distributed in Europe: '' Product Number: 39-0058: Medicare Reinforced Wound Closure Strips 1/4'' X 4 '', Sterile, Box 1000 pouches 5 strips /pouch, Pouch , 5 strips 6 mm X100 mm Sterile EO Product Number: 40-2893: Wound Closure Strips , Sterile (1,000pouches/box) Rx; Pouch Label: Wound Closure Strips 6 mm X100 mm, 1/4'' X 4 '', Rx Product Usage: intended for skin closure and closure support for sutures and staples"," Product 40-2894: Lot Numbers/Expiration Date Lot Numbers/Expiration 2690-090730 2014-07 2690-111128 2016-11 2690-091207 2014-12 2690-111205 2016-12 2690-100309 2015-03 2690-29661 2017-01 2690-100407 2015-04 2690-29775 2017-01 2690-100429 2015-04 2690-120307 2017-03 2690-100505 2015-05 2690-120410 2017-03 2690-100603 2015-06 2690-120425 2017-04 2690-100607 2015-06 2690-120517 2017-05 2690-100615 2015-06 2690-120803 2017-08 2690-100617 2015-06 2690-120822 2017-08 2690-100709 2015-07 2690-120917 2017-09 2690-100728 2015-07 2690-121019 2017-10 2690-101001 2015-10 2690-121106 2017-10 2690-101101 2015-11 2690-121105 2017-11 2690-101117 2015-11 2690-121128 2017-11 2690-101221 2015-12 2690-130107 2018-01 2690-110121 2016-01 2690-130103 2018-01 2690-110201 2016-02 2690-130109 2018-01 2690-110217 2016-02 2690-130215 2018-02 2690-110223 2016-02 2690-130307 2018-03 2690-110310 2016-03 2690-130213 2018-02 2690-110328 2016-03 2690-130306 2018-03 2690-110415 2016-04 2690-130403 2018-04 2690-110426 2016-04 2690-130409 2018-04 2690-110511 2016-02 2690-130415 2018-04 2690-120804 2017-08 '' Product 39-0058 (outside USA): Lot Numbers/ Expiration Date 11305 2016-05 11731 2017-03 11974 2017-08 12353 2018-04 '' Product 40-2893 (outside USA): Lot Numbers/ Expiration Date 10425 2014-11 10504 2014-07 10727 2015-02 11178 2015-10 11179 2015-12 11260 2016-01 11261 2016-02 11558 2016-07 ",".","3286 boxes ( 6,353,000)","Aspen Surgical is recalling Wound Closures because firm could not confirm sterility, after FDA sampling indicated the product may not be sterile. Using the recalled product could lead to infection which may require further treatment including the use of antibiotics. There have been no reports of injuries or illnesses as of 7/18/2013. ",7/18/2013,"07/18/2013",8/28/2013,"08/28/2013"
"Food",65746,"Ongoing","Walong Marketing, Inc.","Buena Park","CA","US","Voluntary: Firm Initiated","Letter","CA","F-1804-2013","Class III","Asian Taste Sun Flower Seeds, 40pk/carton, Net Wt: 8-oz. (227g), Item #1641819, UPC 6 919037 022708.","expiration date BEFORE 8/31/13",,"1090 cartons","Walong Marketing is recalling SunFlower Seeds because it may contain undeclared sulfites.",7/12/2013,"07/12/2013",8/21/2013,"08/21/2013"
"Drugs",65747,"Ongoing","Watson Laboratories Inc","Corona","CA","US","Voluntary: Firm Initiated","Letter","Nationwide","D-823-2013","Class III","Oxycodone and Acetaminophen Capsules, USP 5mg/500 mg, packaged in a)100-count bottle (NDC 0591-0737-01), b) 500-count bottle (NDC 0591-0737-05), Rx only, Manufactured by Watson Laboratories, Inc., Corona, CA92880. ","Lot # a) 444971A, Exp 8/13; b) 444973A, Exp 8/13 ",,"1,260 bottles","Subpotent drug: Two lots of Oxycodone and Acetaminophen Capsules, USP 5/500 mg are being recalled due to low out of specification (OOS) assay result obtained at expiry (24 months) for the oxycodone portion of the product.",7/19/2013,"07/19/2013",7/31/2013,"07/31/2013"
"Biologics",65748,"Terminated","OneBlood, Inc.","Lantana","FL","US","Voluntary: Firm Initiated","Letter","Florida","B-2469-13","Class II","Red Blood Cells","2497273; ",".","1","Blood product, collected from a donor whose suitability to donate was not adequately determined, was distributed.",6/12/2013,"06/12/2013",11/13/2013,"11/13/2013"
"Biologics",65750,"Terminated","OneBlood, Inc.","Lantana","FL","US","Voluntary: Firm Initiated","Letter","Florida","B-2472-13","Class II","Red Blood Cells","W036813024156; ",".","1","Blood products, collected from a donor whose suitability to donate was not adequately determined, were distributed.",6/17/2013,"06/17/2013",11/13/2013,"11/13/2013"
"Biologics",65750,"Terminated","OneBlood, Inc.","Lantana","FL","US","Voluntary: Firm Initiated","Letter","Florida","B-2470-13","Class II","Platelets Pooled Leukocytes Reduced","W036812853139; ",".","1","Blood products, collected from a donor whose suitability to donate was not adequately determined, were distributed.",6/17/2013,"06/17/2013",11/13/2013,"11/13/2013"
"Biologics",65750,"Terminated","OneBlood, Inc.","Lantana","FL","US","Voluntary: Firm Initiated","Letter","Florida","B-2471-13","Class II","Fresh Frozen Plasma","W036813024156; ",".","1","Blood products, collected from a donor whose suitability to donate was not adequately determined, were distributed.",6/17/2013,"06/17/2013",11/13/2013,"11/13/2013"
"Biologics",65752,"Terminated","American National Red Cross Southeastern Michigan Region","Detroit","MI","US","Voluntary: Firm Initiated","Telephone","Michigan","B-2515-13","Class II","Platelets Pheresis Leukocytes Reduced","13X56755; 13X56755; ",".","2","Blood products, labeled leukoreduced without the assurance that they met the criteria for leukoreduced products, were distributed.",5/28/2013,"05/28/2013",11/20/2013,"11/20/2013"
"Food",65754,"Ongoing","Red Mill Farms","Moosic","PA","US","Voluntary: Firm Initiated","E-Mail","PA, GA, NH.","F-1796-2013","Class II","individual 2 oz chocolate macaroons packaged in plastic wrapper labeled as '' Jennies DUTCH CHOCOLATE MACAROON, 2 oz. Red Mill Farms, Inc., Brooklyn, NY''.","Expiration dates 12/1/13 and 1/13/14. ",,"31 cases","A recall was initiated as a result of an undeclared sugar ingredient in the labeling used for Jennies' Dutch Chocolate Macaroons. ",3/20/2013,"03/20/2013",8/21/2013,"08/21/2013"
"Devices",65755,"Ongoing","GE Healthcare, LLC","Waukesha","WI","US","Voluntary: Firm Initiated","Visit","Worldwide Distribution - US Distribution including the states AK, AZ, AR, CA, CO, CT, DE, FL, GA, IL, LA, MD, MI, MN, MO, NE, NV, NM, NY, NC, OH, OR, PA, SC, SD, TN,TX, VA, WA and WI., and the countries of ALGERIA, AUSTRALIA, AUSTRIA, BAHRAIN, BELGIUM, BRIL, CANADA, CHINA, COLOMBIA, DENMARK, EGYPT, FINLAND, FRANCE, GERMANY, INDIA, IRAQ, ISRAEL, ITALY, JAPAN, JORDAN, KOREA, REPUBLIC OF MOLDOVA, NETHERLANDS, NORWAY, POLAND, ROMANIA, RUSSIAN FEDERATION, KINGDOM OF SAUDI ARABIA, SLOVAKIA, SOUTH AFRICA, SPAIN, SWEDEN, SWITZERLAND, TAIWAN, THAILAND, TURKEY, UNITED ARAB EMIRATES, UNITED KINGDOM, UZBEKISTAN, VENEZUELA.","Z-1833-2013","Class II","GE Healthcare, VOLUSON E6, E8, E8 EXPERT, E10 DIAGNOSTIC ULTRASOUND SYSTEM. The device is a general purpose ultrasound system. Specific clinical applications remain the same as previously cleared: Fetal/OB; Abdominal (including GYN, pelvic and infertility monitoring/follicle development); Pediatric; Small Organ (breast, testes, thyroid etc.); Neonatal and Adult Cephalic; Cardiac (adult and pediatric); Musculo-skeletal Conventional and Superficial; Peripheral Vascular; Transvaginal; Transrectal; and Intraoperative (abdominal, PV and neurological).","Mfg Lot or Serial # D16290 D16293 D16294 D16295 D16296 D16297 D16299 D16300 D16301 D16302 D16303 D16304 D16305 D16306 D16309 D16310 D16311 D16312 D16313 D16314 D16315 D16316 D16318 D16319 D16326 D16335 D16336 D16337 D16338 D16339 D16340 D16341 D16342 D16343 D16345 D16346 D16362 D16366 D16367 D16368 D16370 D16371 D16372 D16373 D16374 D16375 D16377 D16378 D16396 D16398 D16399 D16400 D16401 D16402 D16403 D16404 D16405 D16406 D16432 D16433 D16434 D16435 D16436 D16437 D16438 D16439 D16440 D16441 D16453 D16458 D16460 D16461 D16462 D16466 D16467 D16468 D55513 D55514 D55515 D55519 D55520 D55521 D55522 D55538 D55539 D55540 D55541 D55543 D55549 D55550 D55551 D55565 D55566 D55568 D55578 D55579 D55580 D55581 D55582 D55598 D55603 D55605 D55606 D55615 D55616 D55617 D16407 D55524 D04446 D16477 D55516 D55534 D55557 D55588 D16239 D55576 D55623 D55625 D16348 D16349 D16350 D55552 D55553 D55554 D55555 D55560 D16254 D16257 D16257 D55336 D55337 D55338 D55348 D55595 D13829 D15232 D15425 D15973 D16193 D16245 D16248 D16255 D16260 D16262 D16317 D16324 D16334 D16344 D16352 D16358 D16369 D16380 D16384 D16385 D16390 D16393 D16424 D16445 D16448 D16454 D16455 D16464 D16480 D16481 D16482 D16483 D16484 D16486 D16487 D55437 D55517 D55548 D55575 D55593 D55607 D55608 D55611 D55612 D55621 D55624 D55627 D16240 D55518 D55572 D55573 D55574 D55610 D16442 D55510 D55599 D55622 D03382 D16256 D55544 D55629 D05257 D10516 D13472 D15189 D15444 D15454 D16235 D16242 D16244 D16246 D16251 D16264 D16265 D16277 D16279 D16280 D16281 D16284 D16331 D16333 D16347 D16353 D16382 D16387 D16388 D16389 D16409 D16410 D16411 D16412 D16413 D16414 D16415 D16427 D16428 D16429 D16443 D16444 D16449 D16478 D55532 D55556 D55585 D55586 D55587 D00716 D04334 D11004 D15447 D16241 D16258 D16263 D16276 D16286 D16287 D16289 D16291 D16292 ",,"375","GE Healthcare has recently become aware that during use of the Voluson E6 or E8 systems, that an error message Out of Memory can be displayed which could cause the system to freeze. This is an intermittent behavior that also requires a certain workflow. This issue can be resolved by rebooting the system.",7/13/2012,"07/13/2012",8/7/2013,"08/07/2013"
"Drugs",65756,"Ongoing","VistaPharm, Inc.","Largo","FL","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Nationwide.","D-913-2013","Class II","Nystatin Oral Suspension, USP 500,000 units/ 5 mL (NDC 66689-037-01 ) Rx Only, Manufactured by VistaPharm, Inc. Largo, FL 33771","Lot # 240200, 243000, 244800, 245600, 250800 and 253600. Exp 06/13.",".","1,707,050 cups / 5ml ea.","Failed Impurites/Degradation Specifications: Test failure of single largest peak at 18 months.",7/4/2013,"07/04/2013",8/28/2013,"08/28/2013"
"Devices",65757,"Ongoing","Medtronic Inc. Cardiac Rhythm Disease Management","Saint Paul","MN","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution-USA (nationwide) including DC and the states of AZ, AK, CA, DE, GA, IL, KY, MA, MI, MN, MS, NV, NY, NC, OH, PA, TN, and TX, and the countries of AUSTRALIA, BRAZIL, CHILE, INDIA, and SINGAPORE.","Z-1876-2013","Class II","Medtronic Mullins Transseptal Adult 7F, REF 008551. Intended for the introduction of cardiovascular catheters into the left side of the heart. ","Lot Numbers: 50672012, 50676944, 50683123, 50693426, 50710622.",".","269","Medtronic identified a specific labeling issue for specific lots of Mullins Transseptal Catheter Introducer Sheath, model 008551, in which packages labeled as Mullins 7F (French) may actually contain an 8F(French) dilator. Medtronic is requesting the return of potentially mis-labeled Mullins Transseptal Catheter Introducer 7 French Sheaths. Due to the differences in size, an 8F dilator will not fit into a 7F sheath, making any mis-labeled introducer components unusable in a clinical case. ",7/8/2013,"07/08/2013",8/14/2013,"08/14/2013"
"Biologics",65758,"Terminated","South Texas Blood & Tissue Center","San Antonio","TX","US","Voluntary: Firm Initiated","FAX","Florida; Texas","B-2462-13","Class II","Red Blood Cells Leukocytes Reduced","W140912244791; ",".","1","Blood products, collected from a donor who reported high risk behavior, were distributed.",5/13/2013,"05/13/2013",11/13/2013,"11/13/2013"
"Biologics",65758,"Terminated","South Texas Blood & Tissue Center","San Antonio","TX","US","Voluntary: Firm Initiated","FAX","Florida; Texas","B-2463-13","Class II","Blood and Blood Products for Reprocessing","W140912244791; ",".","1","Blood products, collected from a donor who reported high risk behavior, were distributed.",5/13/2013,"05/13/2013",11/13/2013,"11/13/2013"
"Devices",65759,"Ongoing","GE Healthcare, LLC","Waukesha","WI","US","Voluntary: Firm Initiated","Visit","Worldwide Distribution - USA (nationwide) including the states of AL, AK, AZ, AR, CA, CO, DE, FL, GA, ID, IL , IA, MD, MA, MI, MS, MO, NJ, NM, NY, NC, OH, PA, RI, SC, TN,TX, UT,VT, VA and WI., and the countries of ARAB EMIRATES, AUSTRALIA, AUSTRIA, BELGIUM, DENMARK, FINLAND, FRANCE, GERMANY, GREAT BRITAIN, HONG KONG, INDIA, ITALY, JAPAN, NETHERLANDS,NEW ZEALAND, NORWAY, POLAND, RUSSIA, SAUDI ARABIA, SINGAPORE,SOUTH AFRICA, SPAIN, SWEDEN, SWITZERLAND and UNITED EMIRATES.","Z-1849-2013","Class II","GE Healthcare, LOGIQ e Ultrasound System. The LOGIQ i/e and Vivid e is a general purpose ultrasound system intended for use by a qualified physician for evaluation by ultrasound imaging or fluid flow analysis of the human body. Specific clinical applications and exam types include: Fetal/OB; Abdominal (GYN & Urology); Pediatric; Small Organ (breast, testes, thyroid); Neonatal and Adult Cephalic; Cardiac (adult & pediatric); Peripheral Vascular; Intra-operative (abdominal, thoracic and PV), Musculo-skeletal Conventional & Superficial, Transesophageal, Transrectal and Transvaginal, and Thoracic/Pleural for motion/sliding and fluid detection.","Mfg Lot or Serial # 223133WX0 223134WX8 223135WX5 223136WX3 223137WX1 224634WX6 224635WX3 224636WX1 224637WX9 224638WX7 224639WX5 224640WX3 224641WX1 224642WX9 224643WX7 224644WX5 224645WX2 224786WX4 224787WX2 224788WX0 224789WX8 224790WX6 224791WX4 224792WX2 224793WX0 224794WX8 224795WX5 224796WX3 224797WX1 224798WX9 224799WX7 224800WX3 224801WX1 224802WX9 224803WX7 224804WX5 224805WX2 224806WX0 224807WX8 224808WX6 224951WX4 225010WX8 225011WX6 225012WX4 225013WX2 225014WX0 225015WX7 225143WX7 225144WX5 225145WX2 225146WX0 226933WX0 226934WX8 226935WX5 226936WX3 226937WX1 227218WX5 227219WX3 227221WX9 227222WX7 227223WX5 227224WX3 227225WX0 227226WX8 227227WX6 227228WX4 227229WX2 227230WX0 227231WX8 227232WX6 227233WX4 227279WX7 227280WX5 227281WX3 227282WX1 227283WX9 227284WX7 227285WX4 227286WX2 227287WX0 227288WX8 227574WX1 227575WX8 227576WX6 227577WX4 227578WX2 228256WX4 228257WX2 228258WX0 228259WX8 228260WX6 228772WX0 228773WX8 228774WX6 228775WX3 228776WX1 228777WX9 228778WX7 228779WX5 228780WX3 229786WX9 229787WX7 229790WX1 229791WX9 229792WX7 229793WX5 231677WX6 231678WX4 231679WX2 231680WX0 231681WX8 231682WX6 231683WX4 231684WX2 231685WX9 231686WX7 231687WX5 231688WX3 231689WX1 231690WX9 232467WX1 232468WX9 232470WX5 232471WX3 232472WX1 232473WX9 232474WX7 232500WX9 232501WX7 232502WX5 232503WX3 232504WX1 232505WX8 232506WX6 233383WX9 233384WX7 233385WX4 233386WX2 233387WX0 233388WX8 233389WX6 233390WX4 233391WX2 233392WX0 233393WX8 233394WX6 233395WX3 233396WX1 234475WX2 235601WX2 235602WX0 235603WX8 235604WX6 235605WX3 236395WX0 236396WX8 236397WX6 236398WX4 236399WX2 237120WX1 237121WX9 237122WX7 237123WX5 237124WX3 237617WX6 237618WX4 237619WX2 237620WX0 237621WX8 238640WX7 238641WX5 238642WX3 238643WX1 238644WX9 240405WX1 240406WX9 240407WX7 240408WX5 240409WX3 240410WX1 240411WX9 240412WX7 240413WX5 240414WX3 240415WX0 240416WX8 242064WX4 242065WX1 242070WX1 242071WX9 242073WX5 242074WX3 242075WX0 242076WX8 242077WX6 242078WX4 242499WX2 242500WX7 242501WX5 242502WX3 242503WX1 242504WX9 24250",,"588","GE Healthcare became aware of a potential issue associated with the LOGIQ e system. Image data from one patient has the potential to be linked to the patient ID of another patient.",11/9/2012,"11/09/2012",8/7/2013,"08/07/2013"
"Devices",65760,"Ongoing","SpineFrontier, Inc.","Beverly","MA","US","Voluntary: Firm Initiated","E-Mail","Nationwide Distribution including FL, TX, OK, MO, IL, OH, VA, OR, CO, KS, CT","Z-0274-2014","Class II","S-LIFT Extension Shims Extension shims are manufactured from grade 5 titanium and are curved, rectangular slabs which have four protrusions used for ratcheting. They come in straight and pointed varieties, either with or without a tab containing an additional bend. Extension shims are designed to slide down retractor blades, and are optional retractor components utilized during lumbar interbody fusion procedures. They are intended to manipulate tissue and prevent tissue from interfering inside the surgical field.","Part Number/Lot Number: 11-50109 43092R; 11-50109 46415; 11-50109 CT12H013; 11 -50109-1 46415-1; 11-50110 43089; 11-50110 43089R; 11-50110 46416; 11-50110-1 46416-1",".","67","Fit variation among all lots of S-LIFT extension shims with corresponding retractor blades. The firm's investigation revealed that extension shims may not fit down all retractor blades.",8/28/2013,"08/28/2013",11/20/2013,"11/20/2013"
"Drugs",65761,"Ongoing","Vi-Jon, Inc.","Smyrna","TN","US","Voluntary: Firm Initiated","Letter","Nationwide","D-812-2013","Class III","ALCOHOL FREE ANTISEPTIC (cetylpyridinium chloride) Mouth Rinse, 0.07%, mint, 33.8 FL OZ (1 L) bottle, Distributed By The Kroger Co., Cincinnati, OH 45202, UPC 0 41260 33606 5.","Lot #: 0185828, Exp 12/14",,"18,408 bottles","Microbial Contamination of Non-Sterile Products: This product is being recalled because a stability sample was found to be contaminated with Burkholderia contaminans.",7/18/2013,"07/18/2013",7/31/2013,"07/31/2013"
"Drugs",65762,"Ongoing","Myson Corporation, Inc.","Long Beach","CA","US","Voluntary: Firm Initiated","Press Release","Nationwide","D-345-2014","Class I","Volcano Male Enhancement (Proprietary Formula, Pueraria lobata, Cinnamon Bark, Cuscuta, Gui, Licorice, Altractylodes, Dang Condonopsis, Dismutase, Cornus, Rubus, Deng Sen Extract, Panax Ginseng, Cordyceps Sinensis, Go Ji Extract, Superoxide Dismutase) Capsules,1500 mg, 1-count capsule packaged in a black round plastic pop top container","No codes or lots listed on products. ",,"unknown","Marketed Without An Approved NDA/ANDA: All lots of Volcano Liquid and Volcano Capsules, marketed as dietary supplements, are being recalled because they were found to contain undeclared active pharmaceutical ingredients, making them unapproved new drugs.",7/19/2013,"07/19/2013",12/18/2013,"12/18/2013"
"Drugs",65762,"Ongoing","Myson Corporation, Inc.","Long Beach","CA","US","Voluntary: Firm Initiated","Press Release","Nationwide","D-344-2014","Class I","Volcano Male Enhancement Liquid, 2 FL OZ (60 ml) bottle, www.volcanoenhancement.com, DISTRIBUTED BY VOLCANO Long Beach, CA 90813, UPC 6 09613 85996 0.","All lots including 0312-K2, Exp 11/14 ",,"70 bottles","Marketed Without An Approved NDA/ANDA: All lots of Volcano Liquid and Volcano Capsules, marketed as dietary supplements, are being recalled because they were found to contain undeclared active pharmaceutical ingredients, making them unapproved new drugs.",7/19/2013,"07/19/2013",12/18/2013,"12/18/2013"
"Food",65763,"Completed","Kabco Pharmaceuticals, Inc.","Amityville","NY","US","FDA Mandated","Telephone","New York","F-1767-2013","Class II","PERFECT 3000 VANILLA POWDER, FORMULA # 3101. The product is loose powder packaged in bulk drum.","Lot BA13032004A and 13032004B",,"1813.60 Kilograms","Firm had distributed the bulk product in violation of the Consent Decree for Permanent Injunction (12-CV-3468).",4/9/2013,"04/09/2013",8/7/2013,"08/07/2013"
"Food",65763,"Completed","Kabco Pharmaceuticals, Inc.","Amityville","NY","US","FDA Mandated","Telephone","New York","F-1766-2013","Class II","PERFECT 3000 CHOCOLATE POWDER, FORMULA # 3098. The product is loose powder packaged in bulk drum.","Lot BA13032003",,"681.60 Kilograms","Firm had distributed the bulk product in violation of the Consent Decree for Permanent Injunction (12-CV-3468).",4/9/2013,"04/09/2013",8/7/2013,"08/07/2013"
"Devices",65764,"Ongoing","DeRoyal Industries Inc","Powell","TN","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Worldwide Distribution-USA (nationwide) including DC and the states of AL, AR, AZ, CA, CO, CT, FL, GA, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, WA, WI, WV, and the countries of Dubai, Arab Emirates, Quebec, Canada, Japan, and Ireland.","Z-2113-2013","Class II","DeRoyal Insufflation Tubing sets: 1) REF 28-0206 Insufflation Tubing, Laparoscopic Rx Only 2) REF 28-0214 Hi-Flow Insufflation Tubing Rx Only 3) REF 28-0216 Tubing, Insuf w/.3 Micr Filter Rx Only 4) REF 28-0217 Insufflation Tubing, Laparoscopic Rx Only 5) REF 28-0208 Insufflation Tubing w/Vent Rx Only 6) REF 28-0212H Heated Hi-Flow Insufflation Tubing Rx Only. Used during laparoscopic surgical procedures to aid in the insufflation of the abdomen.","All Lots of the Insufflation Tubing Sets are as follows: REF 28-0206 Insufflation Tubing, Laparoscopic, Lot #29074214; REF 28-0214 Hi-Flow Insufflation Tubing Lot #3194170; REF 28-0216 Tubing, Insuf w/.3 Micr Filter Lot #29074249; REF 28-0217 Insufflation Tubing, Laparoscopic Lot #32305010; DeRoyal REF 28-0208 Insufflation Tubing w/Vent Lot #29314302; DeRoyal REF 28-0212H Heated Hi-Flow Insufflation Tubing Lot #29000354.",,"506,632 sets in US; 17,854 sets International","DeRoyal Industries is recalling their product Insufflation Tubing Sets due to materials incompatibility which could possibly result in occlusion at or near the filter housing which could prevent the flow of gas through the device. ",7/15/2013,"07/15/2013",9/4/2013,"09/04/2013"
"Food",65765,"Ongoing"," Plum Inc ","Emeryville","CA","US","Voluntary: Firm Initiated","Letter","Nationwide and Bermuda.","F-1819-2013","Class II","Plum Organics Mighty 4 Essential nutrition blend; Kale, Strawberry, Amaranth, Greek yogurt in 4 oz pouch. Six pouches per box. USDA Organic. Selling case USPC: 846675003409; Case USPC: 00846675003522 Distributed by Plum Inc., Emery ville, CA.","Item 3522 6-Mar-14 7-Mar-14 23-Mar-14 24-Mar-14 25-Mar-14 4-Apr-14 5-Apr-14 6-Apr-14 9-Apr-14 10-Apr-14 11-Apr-14 12-Apr-14 13-Apr-14 18-Apr-14 19-Apr-14 5-May-14 10-May-14 11-May-14 18-May-14 19-May-14 20-May-14 26-May-14 30-May-14 5-Jul-14 6-Jul-14 ",".","81,347 cases, total of all varieties","Intermittent ineffective hermetic seal on pouch package leading to potential spoilage after thermal processing of acidified product .",7/19/2013,"07/19/2013",8/28/2013,"08/28/2013"
"Food",65765,"Ongoing"," Plum Inc ","Emeryville","CA","US","Voluntary: Firm Initiated","Letter","Nationwide and Bermuda.","F-1822-2013","Class II","Plum Organics Mighty 4 Essential nutrition blend; Purple Carrot Berry Quinoa, Greek yogurt in 4 oz pouch. Six pouches per box. USDA Organic. Selling case USPC: 846675003430; Case UPC: 00846675003553. Distributed by Plum Inc., Emeryville, CA.","Item 3553 12-Mar-14 13-Mar-14 14-Mar-14 27-Mar-14 28-Mar-14 29-Mar-14 30-Mar-14 19-Apr-14 20-Apr-14 26-Apr-14 29-Apr-14 1-May-14 8-May-14 9-May-14 20-May-14 23-May-14 24-May-14 25-May-14 13-Jul-14 14-Jul-14. ",".","81,347 cases, total for all varieties","Intermittent ineffective hermetic seal on pouch package leading to potential spoilage after thermal processing of acidified product .",7/19/2013,"07/19/2013",8/28/2013,"08/28/2013"
"Food",65765,"Ongoing"," Plum Inc ","Emeryville","CA","US","Voluntary: Firm Initiated","Letter","Nationwide and Bermuda.","F-1823-2013","Class II","Plum Organics Mighty 4 Essential nutrition blend; Pumpkin Pomegranate Quinoa, Greek yogurt in 4 oz pouch. Six pouches per box. USDA Organic. Selling case UPC: 846675003454 Case USPC: 00846675003577 Distributed by Plum Inc., Emeryville, CA.","Item 3577 11-Mar-14 12-Mar-14 15-Mar-14 16-Mar-14 17-Mar-14 18-Mar-14 25-Apr-14 26-Apr-14 27-Apr-14 5-May-14 6-May-14 7-May-14 8-May-14 26-May-14 27-May-14 28-May-14 31-May-14 3-Jun-14 6-Jun-14 11-Jun-14 12-Jun-14 11-Jul-14 12-Jul-14 23-Mar-14 7-Apr-14 10-Apr-14 11-Apr-14 19-May-14. ",".","81,347 cases; total for all varieties.","Intermittent ineffective hermetic seal on pouch package leading to potential spoilage after thermal processing of acidified product .",7/19/2013,"07/19/2013",8/28/2013,"08/28/2013"
"Food",65765,"Ongoing"," Plum Inc ","Emeryville","CA","US","Voluntary: Firm Initiated","Letter","Nationwide and Bermuda.","F-1821-2013","Class II","Plum Organics Mighty 4 Essential nutrition blend; Sweet Potato Blueberry Millet , Greek yogurt in 4 oz pouch. Six pouches per box. USDA Organic. Selling case USPC: 846675003416; Case USPC:00846675003539 Distributed by Plum Inc., Emeryville, CA.","Item 3539 6-Mar-14 12-Mar-14 25-Mar-14 26-Mar-14 27-Mar-14 2-Apr-14 3-Apr-14 4-Apr-14 21-Apr-14 22-Apr-14 23-Apr-14 2-May-14 3-May-14 4-May-14 12-May-14 13-May-14 20-May-14 21-May-14 22-May-14 23-May-14 29-May-14 31-May-14 6-Jul-14 7-Jul-14 8-Jul-14 9-Jul-14 10-Jul-14 14-Jul-14 15-Jul-14. ",".","81,347 cases. total number for all varieties","Intermittent ineffective hermetic seal on pouch package leading to potential spoilage after thermal processing of acidified product .",7/19/2013,"07/19/2013",8/28/2013,"08/28/2013"
"Food",65765,"Ongoing"," Plum Inc ","Emeryville","CA","US","Voluntary: Firm Initiated","Letter","Nationwide and Bermuda.","F-1820-2013","Class II","Plum Organics Mighty 4 Essential nutrition blend; Spinach, Kiwi, Barley, Greek yogurt in 4 oz pouch. Six pouches per box. USDA Organic. Selling case USPC: 846675003447; Case UPC: 00846675003560 Distributed by Plum Inc., Emeryville, CA.","Item 3560 8-Mar-14 11-Mar-14 19-Mar-14 20-Mar-14 21-Mar-14 22-Mar-14 31-Mar-14 1-Apr-14 7-Apr-14 8-Apr-14 9-Apr-14 23-Apr-14 24-Apr-14 25-Apr-14 27-Apr-14 28-Apr-14 29-Apr-14 4-May-14 14-May-14 15-May-14 16-May-14 17-May-14 25-May-14 26-May-14 28-Jun-14 29-Jun-14 30-Jun-14. ",".","81, 347 cases, total number for all varieties.","Intermittent ineffective hermetic seal on pouch package leading to potential spoilage after thermal processing of acidified product .",7/19/2013,"07/19/2013",8/28/2013,"08/28/2013"
"Food",65766,"Ongoing","CSM Bakery Products North America","Dallas","TX","US","Voluntary: Firm Initiated","E-Mail","CA, FL, GA, IL, IN, MO, NC, NY, OH, OK, PA, TX, UT, WI, and WY","F-1768-2013","Class II","10-inch Supreme Chocolate Layered Cake; 12 units per shipping case","CMS Item Code: 18238200; Lot Code: 6DA 1316100598",,"6,400 cases; 96,000 pounds","Foreign Material Contamination - Ball point pen",7/19/2013,"07/19/2013",8/7/2013,"08/07/2013"
"Food",65767,"Terminated","Mike's Quality Meats, Inc.","Eagle River","AK","US","Voluntary: Firm Initiated","Telephone","Two restaurants - one in Alaska and one in Oregon","F-1882-2013","Class II","Frozen Hot Smoked Vacuum Packed Salmon","Batch number 71013 (this represents the production date) Best by date is 12/10/13",,"65 - 1.5lb pieces","Frozen Hot Smoked Vacuum-Packed Salmon packaged in 1.5 lb packages is being recalled due to missing information on the label. Specifically, ''Important: Keep Frozen Until Used. Thaw under Refrigerated immediately before use''. Failure to provide instructions on the label for proper storage and handling of the product can cause Clostridium botulinum to grow and produce toxin.",7/17/2013,"07/17/2013",9/25/2013,"09/25/2013"
"Food",65768,"Ongoing","Northwest Gourmet Food Products, Inc.","Seattle","WA","US","Voluntary: Firm Initiated","Letter","Distributed in Washington","F-1769-2013","Class I","Hummus is packed in 1.5 oz plastic portion cups with foil peel lids, 100 cups in a case. The product labeled in parts: ''***HUMMUS***1.5 oz*** KEEP REFRIGERATED***","BEST BY: 07/20/13",,"40 cases/100 cups/1.5 oz","Hummus, 1.5 oz. plastic portion cups with foil peel lids, is recalled due to a potential to be contaminated with Listeria monocytogenes.",7/15/2013,"07/15/2013",8/7/2013,"08/07/2013"
"Devices",65769,"Ongoing","MCKESSON TECHNOLOGIES INC","Alpharetta","GA","US","Voluntary: Firm Initiated","Letter","USA Nationwide Distribution in the states AR, MD, NJ, NY, PA, and WV.","Z-2089-2013","Class II","Mc Kesson Anesthesia-Rx Model Number 8.0.2 & 8.0.1 with RapiDispense Product Usage: Automated anesthesia cart that monitors and controls the dispensing of medications, narcotics and supplies during surgical procedures.","Model Number (software version) 8.0.2 & 8.0.1 with RapiDispense",,"106","The firm issued a clinical alert after users reported an issue where the Anesthesia-Rx system was interrupted ANF became temporarily unavailable during use. ",7/22/2013,"07/22/2013",9/4/2013,"09/04/2013"
"Devices",65770,"Terminated","Life Technologies Corporation","Frederick","MD","US","Voluntary: Firm Initiated","Letter","USA Nationwide Distribution in the states of DE, IA, MN, and NC.","Z-2085-2013","Class II","HSV 2 Primers, Catalog #18081020. Analyte Specific Reagent. The HSV-2 primer pair is specific for HSV-2 (Herpes Simplex Virus 2). For use in Clinical laboratories when developing their own diagnostic tests.","Catalog #18081020, Lot #1368760 & Lot #1312093",,"15 kits","Firm received complaints that HSV-2 primers failed to amplify HSV-2 DNA.",5/13/2013,"05/13/2013",9/4/2013,"09/04/2013"
"Food",65771,"Ongoing","Olam Tomato Processors, Inc.","Lemoore","CA","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Product sold at Dollar Tree and Deals, Dollar Express and Dollar Bills stores nationwide.","F-1788-2013","Class II","Mild Chunky Salsa, a Home Style Select brand, in 16oz glass jars, UPC: 3927759137; Product is distributed by Dollar Tree; Product is processed and packaged by Olam Tomato Processors, Inc. Lemoore, CA; The label on the salsa indicates distributed by Greenbrier International, Inc., Chesapeake, VA ","The production codes for the Mild Chunky Salsa (UPC 3927759137) are L12142 (Best By Date June 2015) and L04093 (Best By Date October 2015) ",".","29,801 cases","The firm received complaints of large fragments of glass that were found inside the Mild and Medium Chunky Salsa.",7/18/2013,"07/18/2013",8/14/2013,"08/14/2013"
"Food",65771,"Ongoing","Olam Tomato Processors, Inc.","Lemoore","CA","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Product sold at Dollar Tree and Deals, Dollar Express and Dollar Bills stores nationwide.","F-1789-2013","Class II","Medium Chunky Salsa, a Home Style Select brand, in 16oz glass jars, UPC: 3927759139; Product is distributed by Dollar Tree; Product is processed and packaged by Olam Tomato Processors, Inc. Lemoore, CA; The label on the salsa indicates distributed by Greenbrier International, Inc., Chesapeake, VA ","For the Medium Chunky Salsa (UPC 3927759139) is L01313 (Best By Date July 2015)",".","12,870 cases","The firm received complaints of large fragments of glass that were found inside the Mild and Medium Chunky Salsa.",7/18/2013,"07/18/2013",8/14/2013,"08/14/2013"
"Devices",65773,"Ongoing","Brainlab AG","Feldkirchen",,"DE","Voluntary: Firm Initiated","Letter","Worldwide Distribution - US Distribution only to AR., and the countries of Australia, Germany and Japan.","Z-2083-2013","Class II","BRAINLAB; FRAMELESS SRS QA TARGET POINTER Robotics is a device used to compensate rotational patient misalignment (roll and pitch) in a linear accelerator environment for stereotactic radiosurgery or radiotherapy procedures. The Frameless Radiosurgery Components are a device used for fixation, localization and repositioning of the patient's: head and neck; and head, neck, and shoulders, in a linear accelerator environment for stereotactic radiosurgery/radiotherapy procedures.","Part No. 43410",,"6 units","The Frameless SRS QA Target Pointer - Pointer Cap with the engraved cross hairs may become loose even when only a moderate force is applied to the Pointer Cap.",7/16/2013,"07/16/2013",9/4/2013,"09/04/2013"
"Biologics",65775,"Terminated","New York Blood Center, Inc.","Long Island City","NY","US","Voluntary: Firm Initiated","Telephone","New York","B-2430-13","Class II","Platelets Pheresis Leukocytes Reduced"," W047013141970 ",".","1","Blood product, with an unacceptable pH, was distributed. ",6/6/2013,"06/06/2013",10/30/2013,"10/30/2013"
"Biologics",65776,"Terminated","OneBlood / dba CBCF","Lauderhill","FL","US","Voluntary: Firm Initiated","Telephone","Switzerland; Florida","B-2431-13","Class II","Red Blood Cells","W036810053195; ",".","1","Blood products, which were collected from a donor in which donor suitability was not adequately determined, were distributed.",7/9/2013,"07/09/2013",10/30/2013,"10/30/2013"
"Biologics",65776,"Terminated","OneBlood / dba CBCF","Lauderhill","FL","US","Voluntary: Firm Initiated","Telephone","Switzerland; Florida","B-2432-13","Class III","Blood and Blood Products for Reprocessing","W036810053195; ",".","1","Blood products, which were collected from a donor in which donor suitability was not adequately determined, were distributed.",7/9/2013,"07/09/2013",10/30/2013,"10/30/2013"
"Devices",65777,"Ongoing","Stryker Spine","Allendale","NJ","US","Voluntary: Firm Initiated","Letter","Nationwide Distribution.","Z-1976-2013","Class I","Stryker Oasys Midline Occiput Plate-1) Small 2) Medium 3) Large 4) Large Long 5) Mini. Allows for positioning directly on the midline keel of the occiput.","K093670 Catalog numbers: Small - 48551044 Medium - 48551045 Large - 48551046 Large Long - 48551047 Mini- 48551048 All lots of the above",".","1536 units (US) 880 (Foreign)","Stryker has received reports from customers indicating post-operative fracture of the pin that connects the tulip head to the plate body. ",5/30/2013,"05/30/2013",8/28/2013,"08/28/2013"
"Devices",65778,"Ongoing","Iradimed Corporation","Winter Park","FL","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Worldwide distribution: US (nationwide) including states of: AL, CA, CO, FL, GA, IL, KY, LA, MD, MA, MI, MN, NJ, NY, NC, OH, PA, RI, TN, TX, UT, VA, and WA; and countries of: Australia, Austria, Denmark, Epsom, France, Germany, London, Netherlands, Saudia Arabia, and United Kingdom.","Z-1874-2013","Class I","MRidium 1145 Dose Reduction System (DERS) drug library kit. (This is an option for the MRidium 3860+MR Infusion Pump System). The MRidium 3860+MRI Infusion pump are intended for general hospital or clinical use by medical professional whenever it is required to infuse patients with intra-venous or intra-arterial fluids before, during or after magnetic Resonance imagining (MRI) scans. ","Part number 1145 Lots: 4501,4510, 4538, 4587, 4596, 4675, 4690, 4705, 4738, 4748, 4960, 4970, 5001, 5065, 5104, 6164, 5221, 5240, 5349, 5361, 5517, 5737, 5764, 5881, 6006, 6151, 6170, 6180, 6252, 6470, 6583, 6806, 6881, 6984, and 7213.",".","176 individuals kits","The Dose Error Reduction System (DERS) can indicate an incorrect recommended value for the rate via a specific key sequence during the initial infusion setup. This can result in a risk of over-infusion or under-infusion if the infusion is started with this rate value.",7/1/2013,"07/01/2013",8/14/2013,"08/14/2013"
"Devices",65779,"Ongoing","Becton Dickinson & Co.","Sparks","MD","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution-USA (nationwide) and Puerto Rico and the country of Canada.","Z-2111-2013","Class II","PrepStain Tecan US-I. For use in the screening and detection of cervical cancer.","Catalog Numbers - 799-13000-00 and 799-13000-00R",,"890 instruments","PrepStain system rack setting was incorrectly entered on one PrepStain system during a routine preventive maintenance visit by a BD Field Service Representative.",7/8/2013,"07/08/2013",9/4/2013,"09/04/2013"
"Devices",65779,"Ongoing","Becton Dickinson & Co.","Sparks","MD","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution-USA (nationwide) and Puerto Rico and the country of Canada.","Z-2112-2013","Class II","PrepStain Tecan US-II. For use in the screening and detection of cervical cancer.","Catalog Numbers - 799-14000-00 (490100) and 799-14000-00R (490407)",,"890 instruments","PrepStain system rack setting was incorrectly entered on one PrepStain system during a routine preventive maintenance visit by a BD Field Service Representative.",7/8/2013,"07/08/2013",9/4/2013,"09/04/2013"
"Devices",65779,"Ongoing","Becton Dickinson & Co.","Sparks","MD","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution-USA (nationwide) and Puerto Rico and the country of Canada.","Z-2110-2013","Class II","PrepStain AG. For use in the screening and detection of cervical cancer.","Catalog Numbers - 05CR00021, 05CR00021R, 05CR00022, 05CR00022R, 05CR00023, 05CR00023R",,"890 instruments","PrepStain system rack setting was incorrectly entered on one PrepStain system during a routine preventive maintenance visit by a BD Field Service Representative.",7/8/2013,"07/08/2013",9/4/2013,"09/04/2013"
"Drugs",65780,"Ongoing","Torrent Pharma Inc","Kalamazoo","MI","US","Voluntary: Firm Initiated","Letter","Nationwide","D-830-2013","Class II","Olanzapine Tablets, USP, 10 mg, Rx Only, 30 tablets per bottle, Mfd for: Prasco Laboratories, Mason OH, 45040, USA, Mfd by: Torrent Pharmaceuticals Ltd., Indrad-382 721, Dist. Mehsana India, NDC 66993-463-30 ","Lot #: BS392004A, Exp: 09/2014 ",,"18,721 bottles","Defective Container; This action is being taken as a precautionary measure due to the product being re-packaged in the U.S. using a filler material that (removes or blocks) less moisture than what is approved in the application.",7/22/2013,"07/22/2013",8/7/2013,"08/07/2013"
"Devices",65781,"Ongoing","Nestle HealthCare Nutrition","Minnetonka","MN","US","Voluntary: Firm Initiated","Letter","US Nationwide Distribution - including the states of: AK, AZ, CA, CO, CT, FL, GA, HI, IA, IL, IN, KS, KY, MA, MD, MI, MN, MO, NC, NE, NJ, NM, NV, NY, OH, OK, PA, RI, SC, TN, TX, UT, VA, WA.","Z-1922-2013","Class II","Nestle Nutrition, Compat, Enteral Feeding Tube, sterile, 8 French (REF 08310400), 10 French (REF 08310600), and 12 French (REF 08310500). Product Usage: The Compat Nasogastric Feeding Tube is indicated for the administration of nutrition, fluids and medications into the stomach r small bowel by the naso-enteric, route for patients who have an intact gastrointestinal tract but are physically unable to ingest enough nutrients orally to meet their current needs. ","REF 08310400 - Compat Nasogastric Feeding Tube 8 French (8Fr) in the following lots: 01413G 02412K 08211Z 08712W 14212U 14611P 21512Y 35411H REF 08310500- Compat Nasogastric Feeding Tube 12 French (12Fr) in the following lots: 01211AV 01513N 04111D, 04111P, 04111V 05812F 05912F 06313N 21512G 23412BV 34712V 35411U REF 08310600 - Compat Nasogastric Feeding Tube 10 French (10Fr) in the following lots: 08111M 08712D 10211E 13712W 21512F 05312N ",".","37,310","Nestle HealthCare Nutrition, Inc. is initiating a recall on some of Compat NG Tubes because they have been delivered in an insufficiently sealed pouch, thus compromising the sterility claimed on the label. ",7/24/2013,"07/24/2013",8/14/2013,"08/14/2013"
"Devices",65782,"Ongoing","Elekta, Inc.","Atlanta","GA","US","Voluntary: Firm Initiated","Letter","Nationwide distribution: USA including the states of AZ, CA, FL, GA, MO, NJ, NM, NC, OR, TN and WV.","Z-0138-2014","Class II","Stereotactic Circular Collimator - 3D Line stereotatic Hardware Accessories The device is part of the class of medical devices that are used in radiotherapy for the treatments of head tumors.","933, 935, 936, 937, 940, 843, 844, 845, 846, 847, 833, 834, 835, 836, 837, 801, 802, 803, 804, 805, 908, 909, 910, 911, 912, 889, 890, 891, 892, 893, 894, 848, 849, 850, 851, 852, 853, 974, 975, 976, 977, 978, 1032, 1033, 1034, 928, 929, 930, 931, 932, 980, 981, 982, 983, 984, 1017, 1018, 1019, 1020, 1021, 883, 884, 885, 886, 1012, 1013, 1014, 1015, 1016, 1027, 1028, 1029, 1030, 1031, 941, 942, 943, 944, 945, 946, 947, 948, 949, 950, 903, 904, 905, 906, 907",".","89","Potential for clinical errors.",7/23/2013,"07/23/2013",11/13/2013,"11/13/2013"
"Food",65783,"Ongoing","New Sun Inc","Hendersonville","NC","US","Voluntary: Firm Initiated","Letter","AL, CA, CO, FL GA, HI, ID, IL, IN, IA, KY, ME, MD, MA, MI, MN, MO, NH, NJ, NM, NY, NC, OH, PA, RI, SC, SD, TN, TX, VA, WA","F-1881-2013","Class II","New Sun Immune 101, Dietary Supplement 360 Capsule bottles and 100 capsule bottles, New Sun, Inc, Hendersonville NC 28792 1-800-544-0777 www.newsun.net product No. 74-0","07237 and 07238",".","61,840 capsules","Positive E.coli",7/22/2013,"07/22/2013",9/18/2013,"09/18/2013"
"Food",65783,"Ongoing","New Sun Inc","Hendersonville","NC","US","Voluntary: Firm Initiated","Letter","AL, CA, CO, FL GA, HI, ID, IL, IN, IA, KY, ME, MD, MA, MI, MN, MO, NH, NJ, NM, NY, NC, OH, PA, RI, SC, SD, TN, TX, VA, WA","F-1880-2013","Class II","New Sun JLB Combination, Dietary Supplement, 100 capsule bottle, New Sun, Inc., Hendersonville, NC 1-800-544-0777 www.newsun.net Product No. 78-1","07332 and 07183",".","38,900 capsules","Positive E.coli",7/22/2013,"07/22/2013",9/18/2013,"09/18/2013"
"Drugs",65784,"Ongoing","Baxter Healthcare Corp.","Deerfield","IL","US","Voluntary: Firm Initiated","Letter","Nationwide and Puerto Rico","D-831-2013","Class II","DIANEAL Low Calcium (2.5 mEq/L) Peritoneal Dialysis Solution with 1.5% Dextrose, 5000 mL container, Rx only, Baxter Healthcare Corporation, Deerfield, IL 60015, Product L5B4826, NDC 0941-0409-07 ","Product Code: L5B4826, Lot #: C886820, Exp 11/14",,"39,486 containers","Defective Container: There is a potential for frangible components to be broken, resulting in a leak at the port when the closure is removed.",7/24/2013,"07/24/2013",8/7/2013,"08/07/2013"
"Devices",65785,"Ongoing","Gyrus Medical, Inc","Osseo","MN","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution - USA (nationwide) including the states of AL, AZ, CA, FL, GA, IL, IN, KS,KY, MD, MA, MI, MN, MS, MO, NY, NC, OH, PA, SD, TN, TX, VA and WI., and the countries of BRAZIL, CHINA, AUSTRALIA, CHINA, GERMANY and INDIA.","Z-1983-2013","Class II","GYRUS ACMI, REF 3740, Everest BiCOAG Bipolar Dissecting Forceps 5mm/45 cm, Sterile EO. GYRUS ACMI, REF 3740PK, or REF 94201PK, PKS LYONS, Dissecting Forceps 5mm/45cm, Sterile EO. The Dissectors are sterile, single use electrosurgical devices that are indicated for the electrosurgical coagulation, mechanical grasping, and dissection of tissue during the performance of laparoscopic and general surgical procedures.","REF 3740 150080AC 258624MC G166568CC 381809KD 408020AE JF480565 NY492562 REF 3740PK 128971JB 226730IC 226742IC 226743IC 431894CE 431895CE G128677JB REF 94201PK 102290EB 147428AC 167021CC 198596GC 204439HC 204451HC 249022KC 278142BD 320659DD 344712FD 363953ID 373761JD 389095MD 418231BE G386412KD G461037EE JF493195 ",".","1140","On April 29, 2013 Olympus Surgical Technologies America R&D received results from an accelerated aging study conducted as part of a new market submission. The study found that one of 60 Dissector units that underwent 3 year accelerated aging failed the dye penetration test indicating that the seal on sterile packaging was compromised. The dissector products are labeled with a 3 year shelf life. ",7/24/2013,"07/24/2013",8/28/2013,"08/28/2013"
"Devices",65786,"Ongoing","MITSUBISHI HEAVY INDUSTRIES, LTD., HIROSHIMA MACHINERY WORK","HIROSHIMA",,"JP","Voluntary: Firm Initiated","Letter","Worldwide distribution: US (nationwide) including states of TX and FL; and countries of: Belgium, Italy, Japan and Korea.","Z-1931-2013","Class II","MHI-TM2000 Linear Accelerator System, Software Version 3.0.0 revision 13 or earlier; Proprietary and Trade Name: MHI-TM2000/ VERO (TM); Common Name: Medical Linear Accelerator. MHI-TM2000 Linear Accelerator System is intended for radiation therapy of lesions, tumors and conditions anywhere in the body where radiation treatment is indicated","Serial Numbers #s 201902 and 203901",".","14 (2 in US)","Software anomaly: Mitsubishi Heavy Industries, Ltd. became aware of a potential safety issue associated with the VERO (TM) Linear Accelerator System. The VERO (TM) may save treatment delivery record into wrong location under certain conditions. ",6/21/2013,"06/21/2013",8/14/2013,"08/14/2013"
"Devices",65787,"Ongoing","Stryker Craniomaxillofacial Division","Portage","MI","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution - USA (nationwide) including the countries through Stryker Distribution: Austria, Belgium, Denmark, Estonia, Finland, France, Germany, Ireland, Italy, Latvia, Luxembourg, Netherlands, Norway, Poland, Portugal, Romania, Serbia, Spain, Sweden, Switzerland, United Kingdom, Argentina, Australia, Brazil, Jordan, Kingdom of Saudi Arabia, Kuwait, Latin America (others), New Zealand, Russia, Singapore, South Africa, and United Arabian Emirates.","Z-2054-2013","Class II","Stryker Part Numbers 79-43903 (3cc), 79-43905 (5cc), 79-43910 (10 cc), 79-43915 (15cc), 397003 (3cc), 397005 (5cc), 397010 (10 cc), 397015 (15 cc) HydroSet Injectable HA Bone Substitute Sterile R/EO, nonpyrogenic, Product of Ireland Stryker Injectable Cement is a self-setting, calcium phosphate cement intended for use in the repair of neurosurgical burr holes, contiguous craniotomy cuts and other cranial defects as well as in the augmentation or restoration of bony contour in the craniofacial skeleton. The powder is mixed with the sodium phosphate/PVP solution provided in the kit and loaded into the empty cement delivery syringe to be applied directly to the site for void filling or augmentation.","Part 79-43903, Lot: IC01116, IC01130, IC01204, IC01233, IC01238 Part 79-43905 Lot: IC01084, IC01085, IC01086, IC01093, IC01123, IC01150, IC01166, IC01167, IC01168, IC01180, IC01188, IC01189, IC01190, IC01198, IC01199, IC01200, IC01213, IC01214, IC01229, IC01230, IC01239, IC01240, IC01245, IC01246, IC01270 Part 79-43910 Lot: IC01087, IC01090, IC01091, IC01153, IC01154, IC01163, IC01164, IC01165, IC01179, IC01183, IC01184, IC01201, IC01202, IC01203, IC01231, IC01243, IC01244, IC01248, IC01249, IC01261, IC01264, Part 79-43015 Lot: IC01100, IC01114, IC01161, IC01162, IC01182, IC01211, IC01212, IC01227, IC01228, IC01241, IC01242, IC01252, IC01253, IC01254, IC01267 Part 397003 Lot: IC01092, IC01101, IC01102, IC01103, IC01104, IC01105, IC01106, IC01107, IC01115, IC01127, IC01131, IC01205, IC01220, IC01232, IC01234 Part 397005 Lot: IC01088, IC01094, IC01095, IC01096, IC01097, IC01098, IC01110, IC01111, IC01118, IC01119, IC01120, IC01132, IC01133, IC01134, IC01135, IC01136, IC01137, IC01147, IC01148, IC01149, IC01158, IC01159, IC01160, IC01171, IC01172, IC01181, IC01193, IC01194, IC01195, IC01196, IC01223, IC01224, IC01247Part 79-43910 Lot: IC01087, IC01090, IC01091, IC01153, IC01154 Part 397010 Lot: IC01099, IC01108, IC01109, IC01112, IC01121, IC01138, IC01139, IC01140, IC01141, IC01151, IC01152, IC01155, IC01156, IC01157, IC01173, IC01174, IC01191, IC01192, IC01197, IC01210, IC01216, IC01219, IC01225, IC01226, IC01250, IC01251, IC01263, IC01266, IC01301 Part 397015 Lot: IC01113, IC01122, IC01124, IC01125, IC01142, IC01143, IC01144, IC01145, IC01146, IC01169, IC01170, IC01177, IC01178, IC01185, IC01186, IC01187, IC01206, IC01207, IC01208, IC01209, IC01217, IC01218, IC01221, IC01222, IC01265 ",,"12,719","Stryker received reports of the desiccant bag in the kit leaking silica gel granulate. This could increase exposure to anesthesia during surgical delay up to 60 minutes or inadvertent implantation of silica gel granulate which could cause foreign body reaction including inflammation and might lead to the need for revision surgery.",7/30/2013,"07/30/2013",9/4/2013,"09/04/2013"
"Biologics",65788,"Terminated","Arc Blood Services, New England Region","Dedham","MA","US","Voluntary: Firm Initiated","Telephone","Massachusetts","B-2312-13","Class III","Red Blood Cells Leukocytes Reduced","004FJ98810; 004LV09482; 004LV10277",,"3 units","Blood products, collected from an ineligible donor, were distributed. ",5/4/2013,"05/04/2013",11/6/2013,"11/06/2013"
"Biologics",65788,"Terminated","Arc Blood Services, New England Region","Dedham","MA","US","Voluntary: Firm Initiated","Telephone","Massachusetts","B-2312-13","Class III","Red Blood Cells Leukocytes Reduced","004FJ98810; 004LV09482; 004LV10277",,"3 units","Blood products, collected from an ineligible donor, were distributed. ",5/4/2013,"05/04/2013",11/6/2013,"11/06/2013"
"Biologics",65789,"Terminated","Biomat USA, Inc.","Salt Lake City","UT","US","Voluntary: Firm Initiated","E-Mail","Spain","B-2433-13","Class II","Source Plasma","0630289013; ",".","1","Blood product, collected from a donor who received a tattoo within 12 months of donation, was distributed.",6/25/2013,"06/25/2013",10/30/2013,"10/30/2013"
"Food",65790,"Ongoing","Ferrara Candy Company","Oakbrook Terrace","IL","US","Voluntary: Firm Initiated","E-Mail","US: Nationwide (CA, FL, GA, IA, IL, KS, MN, ND, NY, OR, PA, TX)","F-1805-2013","Class I","Chocolate malted milk balls packaged in 6 lbs. bags and each case contains 3 x 6 lbs. bags; BEST BY 04/17/14; BRCH CHOC","Lot: 20130418",,"293 cases (5,274 lbs.)","One lot of Brach's Chocolate Malted Milk Balls may contain undeclared chocolate covered peanuts and brazil nuts.",7/18/2013,"07/18/2013",8/21/2013,"08/21/2013"
"Devices",65792,"Ongoing","Siemens Medical Solutions USA, Inc","Malvern","PA","US","Voluntary: Firm Initiated","Letter","Nationwide Distribution including MO, MA, NY, WI, OH, NY, CA, FL, NC, MN, and WA.","Z-0271-2014","Class II","Siemens syngo.plaza image processing system image processing radiological system","Model Number 10592457 with serial numbers 100263, 100177, 100138, 100174, 100005, 100006, 100007, 100008, 100009, 100010, 100219, 100201, 100198, 100181, 100249, 100301, 100302, 100157, 100146",".","19","The firm became aware of an unintended behavior when using the syngo.plaza. The ''Rename'' functionality can cause an unintended patient merge if the patient is sent to another system. This issue affects customers who transfer patient data between two or more syngo.plaza or syngo Imaging XS systems. ",8/8/2011,"08/08/2011",11/20/2013,"11/20/2013"
"Devices",65793,"Ongoing","Siemens Medical Solutions USA, Inc","Malvern","PA","US","Voluntary: Firm Initiated","Letter","US Distribution including the states of PA, NJ, DC, VA, MD and DE.","Z-2108-2013","Class II","Axiom Artis systems. C-arm angiographic x-ray system x-ray, angiographic system.","Multiple Model numbers: 10281163, 10281013, 10280959, 10272410, 10094200, 10094142, 10094141, 10094139, 10094137, 10094135, 10093961, 10093902, 8890415, 8890407, 8627718, 8395431, 8395415, 8395399, 8395381, 7728392, 7555373, 755365, 7555357, 7412807, 7151066, 7008605, 5904441, 5904433, 5895003, 475525, 475517, 475509.",,"178","The firm became aware of a potential issue with Axiom Artis systems installed by a third party installer that may involve incorrect channel nuts being used. ",4/26/2013,"04/26/2013",9/4/2013,"09/04/2013"
"Food",65794,"Ongoing","Zip International Group LLC.","Edison","NJ","US","Voluntary: Firm Initiated","Telephone","New York","F-1806-2013","Class I","FOSFOREL brand Herring Fillet in Oil 400 gram (14 oz.) in plastic packaging containers; refrigerated","UPC: 4607095500208; best by dates 5/15/2013 and 7/17/2013 ",,"48 cases - Each case contains 16 units of 14 oz. containers","The product was found to contain Listeria monocytogenes based on sampling and analysis by New York State Department of Agriculture & Markets.",7/19/2013,"07/19/2013",8/21/2013,"08/21/2013"
"Devices",65795,"Ongoing","Siemens Medical Solutions USA, Inc","Malvern","PA","US","Voluntary: Firm Initiated","Letter","US Distribution including the states of AZ, KY, PA, IA WV, FL, MO, OK, CA, AR, MT, NY, KS, and CT.","Z-0172-2014","Class II","Artis zee systems x-ray, angiographic system","model numbers 10094135, 10094137, and 10094141 equipped with a card collimator from a specific lot ",".","17","The firm became aware of a potential issue with Artis zee systems bearing model numbers 10094135, 10094137, and 10094141 equipped with a card collimator from a specific lot where a dislocation of the scatter radiation filter inside the card collimator may occur. ",1/21/2013,"01/21/2013",11/20/2013,"11/20/2013"
"Biologics",65796,"Terminated","Mississippi Valley Reg Bld Ctr","Davenport","IA","US","Voluntary: Firm Initiated","Telephone","Illinois","B-2435-13","Class III","Red Blood Cells Leukocytes Reduced","W333611112431; W333611072795; W333611048740; W333611032457; W333612096401; ",".","5","Blood products, with outdated satellite bags attached, were distributed.",6/3/2013,"06/03/2013",10/30/2013,"10/30/2013"
"Biologics",65796,"Terminated","Mississippi Valley Reg Bld Ctr","Davenport","IA","US","Voluntary: Firm Initiated","Telephone","Illinois","B-2434-13","Class III","Red Blood Cells Leukocytes Reduced Irradiated","W333611036170; W039512040813; ",".","2","Blood products, with outdated satellite bags attached, were distributed.",6/3/2013,"06/03/2013",10/30/2013,"10/30/2013"
"Devices",65797,"Ongoing","GE Healthcare, LLC","Waukesha","WI","US","Voluntary: Firm Initiated","Letter","US Distribution in the state of CT.","Z-1967-2013","Class II","The Discovery NM/CT 570c CT Standalone Scan The Discovery NM/CT 570c hybrid system is a combination of a cardiac dedicated nuclear imaging subsystem and LightSpeed GE CT subsystem. This system is intended for cardiac Nuclear Medicine (NM) diagnostic imaging applications, head and body CT diagnostic imaging applications, as well as attenuation correction and anatomical localization. The Discovery product is a SPECT-CT system. It consists of two back-to-back gantries, the NM Gantry, carrying solid state Cadmium Zinc Telluride (CZT) detectors, the CT Gantry, a single patient table, power distribution unit (PDU), NMV integrated power supply (IPS) , two operator consoles with two acquisition systems (Nuclear and CT), interconnecting cables and associated accessories (ECG gating, etc.). ","Part numbers H3000SA UFC Cardiac SPECT System, H3001JA UFC Gantry, H3001JE UFC VCT Connecting Kit, H3001JF DISCOVERY NMV/CT 570C Connecting Kit. ",".","10 Systems","GE Healthcare has recently become aware of an incident where the wrong part of the patient body was scanned during a CT standalone exam with the Discovery NM/CT 570c",4/10/2013,"04/10/2013",8/28/2013,"08/28/2013"
"Devices",65798,"Ongoing","Boston Scientific CRM Corp","Saint Paul","MN","US","Voluntary: Firm Initiated","Letter","US distribution in the state of Tennessee.","Z-1979-2013","Class II","Boston Scientific, ENERGEN DR ICD, Model E143. The device is an Implantable Cardioverter Defibrillator.","Serial # 108063",".","1 (4 devices were implanted and are not part of this action)","Boston Scientific CRM manufacturing quality system recently discovered test artifacts (related to shock charge time) in a small number of implantable defibrillators (ENERGEN DR ICD model E143) which require further investigation. While these devices successfully passed all manufacturing tests and met all requirements, they showed a slightly longer charge time than other devices during a manufacturing test. ",7/15/2013,"07/15/2013",8/28/2013,"08/28/2013"
"Devices",65799,"Ongoing","Zimmer, Inc.","Warsaw","IN","US","Voluntary: Firm Initiated","Letter"," Worldwide Distribution: US (nationwide) and countries of: Argentina, Australia, Bolivia, Brazil, Canada, Chile, China, Colombia, Costa Rica, Dominican Republic, Ecuador, El Salvador, Germany, Guatemala, Honduras, Hong Kong, India, Israel, Jamaica, Japan, Korea, Malaysia, Mexico, New Zealand, Nicaragua, Panama, Peru, Singapore, Taiwan, Thailand, and Venezula.","Z-0072-2014","Class II","CoCr Head (Not distributed in the United States) Used in total hip replacement. ","Part Number Range:01.01012.405/408",,"604064 total","The low density polyethylene (LDPE) bag used to package implants adheres to the highly polished surface of the devices.",8/30/2013,"08/30/2013",11/6/2013,"11/06/2013"
"Devices",65799,"Ongoing","Zimmer, Inc.","Warsaw","IN","US","Voluntary: Firm Initiated","Letter"," Worldwide Distribution: US (nationwide) and countries of: Argentina, Australia, Bolivia, Brazil, Canada, Chile, China, Colombia, Costa Rica, Dominican Republic, Ecuador, El Salvador, Germany, Guatemala, Honduras, Hong Kong, India, Israel, Jamaica, Japan, Korea, Malaysia, Mexico, New Zealand, Nicaragua, Panama, Peru, Singapore, Taiwan, Thailand, and Venezula.","Z-0073-2014","Class II","NexGen Femoral Component (CR-FLEX GSF PRECOAT SZ C-L; CR-FLEX GSF PRECOAT SZ C-R ; CR-FLEX GSF PCT SZ C-L MINUS; CR-FLEX GSF PCT SZ C-R MINUS ;CR-FLEX GSF PRECOAT SZ D-L; CR-FLEX GSF PRECOAT SZ D-R ;CR-FLEX GSF PCT SZ D-L MINUS ; CR-FLEX GSF PCT SZ D-R MINUS ;CR-FLEX GSF PRECOAT SZ E-L CR-FLEX GSF PRECOAT SZ E-R ;CR-FLEX GSF PCT SZ E-L MINUS ;CR-FLEX GSF PCT SZ E-R MINUS ;CR-FLEX GSF PRECOAT SZ F-L ;CR-FLEX GSF PRECOAT SZ F-R ;CR-FLEX GSF PCT SZ F-L MINUS ;CR-FLEX GSF PCT SZ F-R MINUS ;CR-FLEX GSF PRECOAT SZ G-L ;CR-FLEX GSK PRECOAT SZ G-R ;CR-FLEX GSF PCT SZ G-L MINUS ;CR-FLEX GSF PCT SZ G-R MINUS ; LPS-FLEX GSF OPT SZ C-L ; LPS-FLEX GSF OPT SZ C-R ;LPS-FLEX GSF OPT SZ D-L ;LPS-FLEX GSF OPT SZ D-R ;LPS-FLEX GSF OPT SZ E-L ;LPS-FLEX GSF OPT SZ E-R ;LPS-FLEX GSK OPT SZ F-L ;LPS-FLEX GSF OPT SZ F-R ;LPS-FLEX GSF OPT SZ G-L ; LPS-FLEX GSF OPT SZ G-R ;CR-FLEX PCT FEM B-L; CR-FLEX PCT FEM B-R; CR-FLEX PCT FEM C-L; CR-FLEX PCT FEM C-R; CR-FLEX PCT FEM C-L MINUS; CR-FLEX PCT FEM C-R MINUS; CR-FLEX PCT FEM D-L; CR-FLEX PCT FEM D-R; CR-FLEX PCT FEM D-L MINUS; CR-FLEX PCT FEM D-R MINUS; CR-FLEX PCT FEM E-L; CR-FLEX PCT FEM E-R; CR-FLEX PCT FEM E-L MINUS; CR-FLEX PCT FEM E-R MINUS; CR-FLEX PCT FEM F-L; CR-FLEX PCT FEM F-R; CR-FLEX PCT FEM F-L MINUS; CR-FLEX PCT FEM F-R MINUS; CR-FLEX PCT FEM G-L; CR-FLEX PCT FEM G-R; CR-FLEX PCT FEM G-L MINUS; CR-FLEX PCT FEM G-R MINUS; CR-FLEX POR FEM B-L; CR-FLEX POR FEM B-R; CR-FLEX POR FEM C-L; CR-FLEX POR FEM C-R; CR-FLEX POR FEM C-L MINUS; CR-FLEX POR FEM C-R MINUS; CR-FLEX POR FEM D-L; CR-FLEX POR FEM D-R; CR-FLEX POR FEM D-L MINUS; CR-FLEX POR FEM D-R MINUS; CR-FLEX POR FEM E-L; CR-FLEX POR FEM E-R; CR-FLEX POR FEM E-L MINUS; CR-FLEX POR FEM E-R; MINUS; CR-FLEX POR FEM F-L; CR-FLEX POR FEM F-R ;CR-FLEX POR FEM F-L MINUS; CR-FLEX POR FEM F-R MINUS; CR-FLEX POR FEM G-L; CR-FLEX POR FEM G-R; CR-FLEX POR FEM G-L MINUS CR-FLEX POR FEM G-R MINUS; CR-FLEX OPT FEM B-L; CR-FLEX OPT FEM B-R; CR-FLEX OPT FEM C-L; CR-FLEX OPT FEM C-R; CR-FLEX OPT FEM C-L MINUS; CR-FLEX OPT FEM C-R MINUS; CR-","Part Number Range: 005750, 5764, 5950, 5952, 5956, 5960, 5962, 5964, 5966, 5970, 5972, 5990, 5992, 5994, and 5996-011/018-01/92. ",,"604064 total","The low density polyethylene (LDPE) bag used to package implants adheres to the highly polished surface of the devices.",8/30/2013,"08/30/2013",11/6/2013,"11/06/2013"
"Devices",65799,"Ongoing","Zimmer, Inc.","Warsaw","IN","US","Voluntary: Firm Initiated","Letter"," Worldwide Distribution: US (nationwide) and countries of: Argentina, Australia, Bolivia, Brazil, Canada, Chile, China, Colombia, Costa Rica, Dominican Republic, Ecuador, El Salvador, Germany, Guatemala, Honduras, Hong Kong, India, Israel, Jamaica, Japan, Korea, Malaysia, Mexico, New Zealand, Nicaragua, Panama, Peru, Singapore, Taiwan, Thailand, and Venezula.","Z-0076-2014","Class II","Zimmer Unicompartmental Knee Femoral Component. Indicated for patients with painful and/or disabling knee joint. ","Part Number Range:00-5842-011/017-01/02 ",,"32537","The low density polyethylene (LDPE) bag used to package implants adheres to the highly polished surface of the devices.",8/30/2013,"08/30/2013",11/6/2013,"11/06/2013"
"Devices",65799,"Ongoing","Zimmer, Inc.","Warsaw","IN","US","Voluntary: Firm Initiated","Letter"," Worldwide Distribution: US (nationwide) and countries of: Argentina, Australia, Bolivia, Brazil, Canada, Chile, China, Colombia, Costa Rica, Dominican Republic, Ecuador, El Salvador, Germany, Guatemala, Honduras, Hong Kong, India, Israel, Jamaica, Japan, Korea, Malaysia, Mexico, New Zealand, Nicaragua, Panama, Peru, Singapore, Taiwan, Thailand, and Venezula.","Z-0068-2014","Class II","Multipolar Bipolar Cup METAL SHELL 38 MM OD through 71 MM OD. Indicated in fracture dislocation of the hip. ","Part Number Range: 00-5001-038/072-00 ",,"72806","The low density polyethylene (LDPE) bag used to package implants adheres to the highly polished surface of the devices.",8/30/2013,"08/30/2013",11/6/2013,"11/06/2013"
"Devices",65799,"Ongoing","Zimmer, Inc.","Warsaw","IN","US","Voluntary: Firm Initiated","Letter"," Worldwide Distribution: US (nationwide) and countries of: Argentina, Australia, Bolivia, Brazil, Canada, Chile, China, Colombia, Costa Rica, Dominican Republic, Ecuador, El Salvador, Germany, Guatemala, Honduras, Hong Kong, India, Israel, Jamaica, Japan, Korea, Malaysia, Mexico, New Zealand, Nicaragua, Panama, Peru, Singapore, Taiwan, Thailand, and Venezula.","Z-0077-2014","Class II","Gender Solutions'' Patello-Femoral Component ","Part Number Range:00-5926-011/015-01/02 ",,"5103","The low density polyethylene (LDPE) bag used to package implants adheres to the highly polished surface of the devices.",8/30/2013,"08/30/2013",11/6/2013,"11/06/2013"
"Devices",65799,"Ongoing","Zimmer, Inc.","Warsaw","IN","US","Voluntary: Firm Initiated","Letter"," Worldwide Distribution: US (nationwide) and countries of: Argentina, Australia, Bolivia, Brazil, Canada, Chile, China, Colombia, Costa Rica, Dominican Republic, Ecuador, El Salvador, Germany, Guatemala, Honduras, Hong Kong, India, Israel, Jamaica, Japan, Korea, Malaysia, Mexico, New Zealand, Nicaragua, Panama, Peru, Singapore, Taiwan, Thailand, and Venezula.","Z-0075-2014","Class II","Natural-Knee Flex Femoral Component. Provides increased flexion capability. ","Part Number Range: 00-5410,5412,5414,and 5416-013/018-01/02.",,"33987","The low density polyethylene (LDPE) bag used to package implants adheres to the highly polished surface of the devices.",8/30/2013,"08/30/2013",11/6/2013,"11/06/2013"
"Devices",65799,"Ongoing","Zimmer, Inc.","Warsaw","IN","US","Voluntary: Firm Initiated","Letter"," Worldwide Distribution: US (nationwide) and countries of: Argentina, Australia, Bolivia, Brazil, Canada, Chile, China, Colombia, Costa Rica, Dominican Republic, Ecuador, El Salvador, Germany, Guatemala, Honduras, Hong Kong, India, Israel, Jamaica, Japan, Korea, Malaysia, Mexico, New Zealand, Nicaragua, Panama, Peru, Singapore, Taiwan, Thailand, and Venezula.","Z-0079-2014","Class II","Sidus'' Head (Not distributed in the United States) ","Part Number Range: 01.04555.380/525",,"0 in USA","The low density polyethylene (LDPE) bag used to package implants adheres to the highly polished surface of the devices.",8/30/2013,"08/30/2013",11/6/2013,"11/06/2013"
"Devices",65799,"Ongoing","Zimmer, Inc.","Warsaw","IN","US","Voluntary: Firm Initiated","Letter"," Worldwide Distribution: US (nationwide) and countries of: Argentina, Australia, Bolivia, Brazil, Canada, Chile, China, Colombia, Costa Rica, Dominican Republic, Ecuador, El Salvador, Germany, Guatemala, Honduras, Hong Kong, India, Israel, Jamaica, Japan, Korea, Malaysia, Mexico, New Zealand, Nicaragua, Panama, Peru, Singapore, Taiwan, Thailand, and Venezula.","Z-0080-2014","Class II","NexGen CR-Flex Mobile Bearing Tibial Component 9 (Not distributed in the United States) ","Part Number Range:005930-010/080-01/02",,"3475","The low density polyethylene (LDPE) bag used to package implants adheres to the highly polished surface of the devices.",8/30/2013,"08/30/2013",11/6/2013,"11/06/2013"
"Devices",65799,"Ongoing","Zimmer, Inc.","Warsaw","IN","US","Voluntary: Firm Initiated","Letter"," Worldwide Distribution: US (nationwide) and countries of: Argentina, Australia, Bolivia, Brazil, Canada, Chile, China, Colombia, Costa Rica, Dominican Republic, Ecuador, El Salvador, Germany, Guatemala, Honduras, Hong Kong, India, Israel, Jamaica, Japan, Korea, Malaysia, Mexico, New Zealand, Nicaragua, Panama, Peru, Singapore, Taiwan, Thailand, and Venezula.","Z-0072-2014","Class II","CoCr Head (Not distributed in the United States) Used in total hip replacement. ","Part Number Range:01.01012.405/408",,"604064 total","The low density polyethylene (LDPE) bag used to package implants adheres to the highly polished surface of the devices.",8/30/2013,"08/30/2013",11/6/2013,"11/06/2013"
"Devices",65799,"Ongoing","Zimmer, Inc.","Warsaw","IN","US","Voluntary: Firm Initiated","Letter"," Worldwide Distribution: US (nationwide) and countries of: Argentina, Australia, Bolivia, Brazil, Canada, Chile, China, Colombia, Costa Rica, Dominican Republic, Ecuador, El Salvador, Germany, Guatemala, Honduras, Hong Kong, India, Israel, Jamaica, Japan, Korea, Malaysia, Mexico, New Zealand, Nicaragua, Panama, Peru, Singapore, Taiwan, Thailand, and Venezula.","Z-0076-2014","Class II","Zimmer Unicompartmental Knee Femoral Component. Indicated for patients with painful and/or disabling knee joint. ","Part Number Range:00-5842-011/017-01/02 ",,"32537","The low density polyethylene (LDPE) bag used to package implants adheres to the highly polished surface of the devices.",8/30/2013,"08/30/2013",11/6/2013,"11/06/2013"
"Devices",65799,"Ongoing","Zimmer, Inc.","Warsaw","IN","US","Voluntary: Firm Initiated","Letter"," Worldwide Distribution: US (nationwide) and countries of: Argentina, Australia, Bolivia, Brazil, Canada, Chile, China, Colombia, Costa Rica, Dominican Republic, Ecuador, El Salvador, Germany, Guatemala, Honduras, Hong Kong, India, Israel, Jamaica, Japan, Korea, Malaysia, Mexico, New Zealand, Nicaragua, Panama, Peru, Singapore, Taiwan, Thailand, and Venezula.","Z-0078-2014","Class II","Natural-Knee II Femoral Component ","Part Number Range:6212, 6307-00-006/051 ",,"13483","The low density polyethylene (LDPE) bag used to package implants adheres to the highly polished surface of the devices.",8/30/2013,"08/30/2013",11/6/2013,"11/06/2013"
"Devices",65799,"Ongoing","Zimmer, Inc.","Warsaw","IN","US","Voluntary: Firm Initiated","Letter"," Worldwide Distribution: US (nationwide) and countries of: Argentina, Australia, Bolivia, Brazil, Canada, Chile, China, Colombia, Costa Rica, Dominican Republic, Ecuador, El Salvador, Germany, Guatemala, Honduras, Hong Kong, India, Israel, Jamaica, Japan, Korea, Malaysia, Mexico, New Zealand, Nicaragua, Panama, Peru, Singapore, Taiwan, Thailand, and Venezula.","Z-0070-2014","Class II","Versys Beaded Fullcoat Femoral Stem (POR FULL-CT FEM ST 11X160MM; VERSYS BEADED FC 11X200MM 8ST; POR FULLCT FEM ST 11 LOW EXT; POR FULLCT FEM ST 11 EXT; POR FLCT FEM STEM LM 11X160MM; POR FULLCT LM FEM ST 11 EXT POR FULL-CT FEM ST 12X160MM VERSYS BEADED FC 12X200MM 8 ST POR FULLCT FEM ST 12 LOW EXT POR FLCT FEM ST 12.0X190 STR POR FULLCT FEM ST 12 EXT POR FULL-CT FEM ST LM 12X160MM POR FULLCT LM FEM ST 12 EXT POR FULL-CT FEM ST 13X160MM VERSYS HIP SYSTEM REVISION FEMORAL BEADED FULLCOAT PLUS COLL POR FULLCT FEM ST 13 LOW EXT POR FLCT FEM ST 13.5X190 STR POR FULLCT FEM ST 13 EXT POR FULL-CT FEM ST LM 13X160MM POR FULLCT LM FEM ST 13 EXT POR FULL-CT FEM ST 14X160MM VERSYS BEADED FC 14X200MM 8 ST POR FULLCT FEM ST 14 LOW EXT POR FULLCT FEM ST 14 EXT POR FULL-CT FEM ST LM 14X160MM POR FULLCT LM FEM ST 14 EXT POR FULL-CT FEM ST 15X160MM VERSYS BEADED FC 15X200MM 8 ST POR FULLCT FEM ST 15 LOW EXT POR FLCT FEM ST 15.0X190 STR POR FLCT FEM ST 15.0X250 STR POR FULLCT FEM ST 15 EXT POR FULL-CT FEM ST LM 15X160MM POR FULLCT FEM ST 15 XEXT POR FULLCT LM FEM ST 15 EXT POR FULL-CT FEM ST 16X160MM VERSYS BEADED FC 16X200MM 8 ST POR FULLCT FEM ST 16 LOW EXT POR FLCT FEM ST 16.5X190 STR POR FLCT FEM ST 16.5X250 STR POR FULLCT FEM ST 16 EXT POR FULL-CT FEM ST LM 16X160MM POR FULLCT FEM ST 16 XEXT POR FULLCT LM FEM ST 16 EXT POR FULL-CT FEM ST 17X160MM VERSYS BEADED FC 17X200MM 8 ST POR FULLCT FEM ST 17 EXT POR FULL-CT FEM ST LM 17X160MM POR FULLCT FEM ST 17 XEXT POR FULLCT LM FEM ST 17 EXT POR FULL-CT FEM ST 18X160MM VERSYS BEADED FC 18X200MM 8 ST POR FLCT FEM ST 18.0X190 STR POR FLCT FEM ST 18.0X250 STR POR FULLCT FEM ST 18 EXT POR FULL-CT FEM ST LM 18X160MM POR FULLCT FEM ST 18 XEXT POR FULLCT LM FEM ST 18 EXT POR FULL-CT FEM ST 19X160MM POR FLCT FEM ST 19.5X190 STR POR FLCT FEM ST 19.5X250 STR POR FULLCT FEM ST 19 EXT POR FLCT FEM STEM LM 19X160MM POR FULLCT FEM ST 19 XEXT POR FULLCT LM FEM ST 19 EXT POR FULL-CT FEM ST 20X160MM VERSYS BEADED FC 20X200MM 8 ST ","Part Number Range: 00-7843-011/022-06/56",,"6380","The low density polyethylene (LDPE) bag used to package implants adheres to the highly polished surface of the devices.",8/30/2013,"08/30/2013",11/6/2013,"11/06/2013"
"Devices",65799,"Ongoing","Zimmer, Inc.","Warsaw","IN","US","Voluntary: Firm Initiated","Letter"," Worldwide Distribution: US (nationwide) and countries of: Argentina, Australia, Bolivia, Brazil, Canada, Chile, China, Colombia, Costa Rica, Dominican Republic, Ecuador, El Salvador, Germany, Guatemala, Honduras, Hong Kong, India, Israel, Jamaica, Japan, Korea, Malaysia, Mexico, New Zealand, Nicaragua, Panama, Peru, Singapore, Taiwan, Thailand, and Venezula.","Z-0070-2014","Class II","Versys Beaded Fullcoat Femoral Stem (POR FULL-CT FEM ST 11X160MM; VERSYS BEADED FC 11X200MM 8ST; POR FULLCT FEM ST 11 LOW EXT; POR FULLCT FEM ST 11 EXT; POR FLCT FEM STEM LM 11X160MM; POR FULLCT LM FEM ST 11 EXT POR FULL-CT FEM ST 12X160MM VERSYS BEADED FC 12X200MM 8 ST POR FULLCT FEM ST 12 LOW EXT POR FLCT FEM ST 12.0X190 STR POR FULLCT FEM ST 12 EXT POR FULL-CT FEM ST LM 12X160MM POR FULLCT LM FEM ST 12 EXT POR FULL-CT FEM ST 13X160MM VERSYS HIP SYSTEM REVISION FEMORAL BEADED FULLCOAT PLUS COLL POR FULLCT FEM ST 13 LOW EXT POR FLCT FEM ST 13.5X190 STR POR FULLCT FEM ST 13 EXT POR FULL-CT FEM ST LM 13X160MM POR FULLCT LM FEM ST 13 EXT POR FULL-CT FEM ST 14X160MM VERSYS BEADED FC 14X200MM 8 ST POR FULLCT FEM ST 14 LOW EXT POR FULLCT FEM ST 14 EXT POR FULL-CT FEM ST LM 14X160MM POR FULLCT LM FEM ST 14 EXT POR FULL-CT FEM ST 15X160MM VERSYS BEADED FC 15X200MM 8 ST POR FULLCT FEM ST 15 LOW EXT POR FLCT FEM ST 15.0X190 STR POR FLCT FEM ST 15.0X250 STR POR FULLCT FEM ST 15 EXT POR FULL-CT FEM ST LM 15X160MM POR FULLCT FEM ST 15 XEXT POR FULLCT LM FEM ST 15 EXT POR FULL-CT FEM ST 16X160MM VERSYS BEADED FC 16X200MM 8 ST POR FULLCT FEM ST 16 LOW EXT POR FLCT FEM ST 16.5X190 STR POR FLCT FEM ST 16.5X250 STR POR FULLCT FEM ST 16 EXT POR FULL-CT FEM ST LM 16X160MM POR FULLCT FEM ST 16 XEXT POR FULLCT LM FEM ST 16 EXT POR FULL-CT FEM ST 17X160MM VERSYS BEADED FC 17X200MM 8 ST POR FULLCT FEM ST 17 EXT POR FULL-CT FEM ST LM 17X160MM POR FULLCT FEM ST 17 XEXT POR FULLCT LM FEM ST 17 EXT POR FULL-CT FEM ST 18X160MM VERSYS BEADED FC 18X200MM 8 ST POR FLCT FEM ST 18.0X190 STR POR FLCT FEM ST 18.0X250 STR POR FULLCT FEM ST 18 EXT POR FULL-CT FEM ST LM 18X160MM POR FULLCT FEM ST 18 XEXT POR FULLCT LM FEM ST 18 EXT POR FULL-CT FEM ST 19X160MM POR FLCT FEM ST 19.5X190 STR POR FLCT FEM ST 19.5X250 STR POR FULLCT FEM ST 19 EXT POR FLCT FEM STEM LM 19X160MM POR FULLCT FEM ST 19 XEXT POR FULLCT LM FEM ST 19 EXT POR FULL-CT FEM ST 20X160MM VERSYS BEADED FC 20X200MM 8 ST ","Part Number Range: 00-7843-011/022-06/56",,"6380","The low density polyethylene (LDPE) bag used to package implants adheres to the highly polished surface of the devices.",8/30/2013,"08/30/2013",11/6/2013,"11/06/2013"
"Devices",65799,"Ongoing","Zimmer, Inc.","Warsaw","IN","US","Voluntary: Firm Initiated","Letter"," Worldwide Distribution: US (nationwide) and countries of: Argentina, Australia, Bolivia, Brazil, Canada, Chile, China, Colombia, Costa Rica, Dominican Republic, Ecuador, El Salvador, Germany, Guatemala, Honduras, Hong Kong, India, Israel, Jamaica, Japan, Korea, Malaysia, Mexico, New Zealand, Nicaragua, Panama, Peru, Singapore, Taiwan, Thailand, and Venezula.","Z-0078-2014","Class II","Natural-Knee II Femoral Component ","Part Number Range:6212, 6307-00-006/051 ",,"13483","The low density polyethylene (LDPE) bag used to package implants adheres to the highly polished surface of the devices.",8/30/2013,"08/30/2013",11/6/2013,"11/06/2013"
"Devices",65799,"Ongoing","Zimmer, Inc.","Warsaw","IN","US","Voluntary: Firm Initiated","Letter"," Worldwide Distribution: US (nationwide) and countries of: Argentina, Australia, Bolivia, Brazil, Canada, Chile, China, Colombia, Costa Rica, Dominican Republic, Ecuador, El Salvador, Germany, Guatemala, Honduras, Hong Kong, India, Israel, Jamaica, Japan, Korea, Malaysia, Mexico, New Zealand, Nicaragua, Panama, Peru, Singapore, Taiwan, Thailand, and Venezula.","Z-0069-2014","Class II","CPT Femoral Stem (CPT 12/14 STEM SIZE 0 COCR; CPT 12/14 SIZE 0 COCR EXT; CPT 12/14 STEM SIZE 1 COCR; CPT 12/14 SIZE 1 COCR EXT CPT 12/14 STEM SIZE 2 COCR; CPT 12/14 SIZE 2 COCR EXT; CPT 12/14 SIZE 2 COCR 180MM; CPT 12/14 SIZE2 COCR XEXT; CPT 12/14 STEM SIZE 3 COCR; CPT 12/14 SIZE 3 COCR EXT; CPT 12/14 SZ 3 COCR 180MM EXT; CPT 12/14 SIZE 3 COCR XEXT; CPT 12/14 STEM SIZE 4 COCR; CPT 12/14 SIZE 4 COCR EXT; CPT 12/14 SIZE 4 COCR EXT; CPT 12/14 SZ 4 COCR 230MM EXT; CPT 12/14 SZ 4 COCR 260MM EXT; CPT 12/14 SIZE 4 COCR XEXT; CPT 12/14 STEM SIZE 5 COCR; CPT 12/14 SIZE 5 COCR EXT; CPT 12/14 SIZE 5 COCR XEXT; CPT 12/14 STEM 2-180 VALGUSNCK; CPT 12/14 STEM 3-180 VALGUSNCK; CPT 12/14 STEM X-SML COCR; and CPT 12/14 STEM SML COCR). Indicated for cemented use in patients suffering from severe hip pain. ","Part Number Range: 00-8114-000/050-00/30",,"24561","The low density polyethylene (LDPE) bag used to package implants adheres to the highly polished surface of the devices.",8/30/2013,"08/30/2013",11/6/2013,"11/06/2013"
"Devices",65799,"Ongoing","Zimmer, Inc.","Warsaw","IN","US","Voluntary: Firm Initiated","Letter"," Worldwide Distribution: US (nationwide) and countries of: Argentina, Australia, Bolivia, Brazil, Canada, Chile, China, Colombia, Costa Rica, Dominican Republic, Ecuador, El Salvador, Germany, Guatemala, Honduras, Hong Kong, India, Israel, Jamaica, Japan, Korea, Malaysia, Mexico, New Zealand, Nicaragua, Panama, Peru, Singapore, Taiwan, Thailand, and Venezula.","Z-0071-2014","Class II","Metasul Head. Intended for use either with or without bone cement in total hip arthroplasty. ","Part Number Range:00-8770-040-01/05 & 01.01062.405/408",,"194 (8770-040)","The low density polyethylene (LDPE) bag used to package implants adheres to the highly polished surface of the devices.",8/30/2013,"08/30/2013",11/6/2013,"11/06/2013"
"Devices",65799,"Ongoing","Zimmer, Inc.","Warsaw","IN","US","Voluntary: Firm Initiated","Letter"," Worldwide Distribution: US (nationwide) and countries of: Argentina, Australia, Bolivia, Brazil, Canada, Chile, China, Colombia, Costa Rica, Dominican Republic, Ecuador, El Salvador, Germany, Guatemala, Honduras, Hong Kong, India, Israel, Jamaica, Japan, Korea, Malaysia, Mexico, New Zealand, Nicaragua, Panama, Peru, Singapore, Taiwan, Thailand, and Venezula.","Z-0068-2014","Class II","Multipolar Bipolar Cup METAL SHELL 38 MM OD through 71 MM OD. Indicated in fracture dislocation of the hip. ","Part Number Range: 00-5001-038/072-00 ",,"72806","The low density polyethylene (LDPE) bag used to package implants adheres to the highly polished surface of the devices.",8/30/2013,"08/30/2013",11/6/2013,"11/06/2013"
,65799,"Ongoing","Zimmer, Inc.","Warsaw","IN","US","Voluntary: Firm Initiated","Letter"," Worldwide Distribution: US (nationwide) and countries of: Argentina, Australia, Bolivia, Brazil, Canada, Chile, China, Colombia, Costa Rica, Dominican Republic, Ecuador, El Salvador, Germany, Guatemala, Honduras, Hong Kong, India, Israel, Jamaica, Japan, Korea, Malaysia, Mexico, New Zealand, Nicaragua, Panama, Peru, Singapore, Taiwan, Thailand, and Venezula.","Z-0080-2014","Class II","NexGen CR-Flex Mobile Bearing Tibial Component 9 (Not distributed in the United States) ","Part Number Range:005930-010/080-01/02",,"3475","The low density polyethylene (LDPE) bag used to package implants adheres to the highly polished surface of the devices.",8/30/2013,"08/30/2013",11/6/2013,"11/06/2013"
"Devices",65799,"Ongoing","Zimmer, Inc.","Warsaw","IN","US","Voluntary: Firm Initiated","Letter"," Worldwide Distribution: US (nationwide) and countries of: Argentina, Australia, Bolivia, Brazil, Canada, Chile, China, Colombia, Costa Rica, Dominican Republic, Ecuador, El Salvador, Germany, Guatemala, Honduras, Hong Kong, India, Israel, Jamaica, Japan, Korea, Malaysia, Mexico, New Zealand, Nicaragua, Panama, Peru, Singapore, Taiwan, Thailand, and Venezula.","Z-0074-2014","Class II","NexGen Femoral Component (CR-FLEX GSF POR FEM, C-L; CR-FLEX GSF POR FEM, C-R; CR-FLEX GSF POR FEM, C-L MINUS; CR-FLEX GSF POR FEM, C-R MINUS; CR-FLEX GSF POR FEM, D-L; CR-FLEX GSF POR FEM, D-R CR-FLEX GSF POR FEM, D-L MINUS; CR-FLEX GSF POR FEM, D-R MINUS CR-FLEX GSF POR FEM, E-L; CR-FLEX GSF POR FEM, E-R; CR-FLEX GSF POR FEM, E-L MINUS; CR-FLEX GSF POR FEM, E-R MINUS; CR-FLEX GSF POR FEM, F-L ; CR-FLEX GSF POR FEM, F-R; CR-FLEX GSF POR FEM, F-L MINUS; CR-FLEX GSF POR FEM, F-R MINUS; CR-FLEX GSF POR FEM, G-L CR-FLEX GSF POR FEM, G-R; CR-FLEX GSF POR FEM, G-L MINUS CR-FLEX GSF POR FEM, G-R MINUS; NEXGEN GSF POROUS FEMORAL LPS FLEX SIZE C, LEFT; NEXGEN GSF POROUS FEMORAL LPS FLEX SIZE C, RIGHT; NEXGEN GSF POROUS FEMORAL LPS FLEX SIZE D, LEFT; NEXGEN GSF POROUS FEMORAL LPS FLEX SIZE D, RIGHT; LPS-FLEX GSF POR FEM, E-L; NEXGEN GSF POROUS FEMORAL LPS FLEX SIZE E, RIGHT; NEXGEN GSF POROUS FEMORAL LPS FLEX SIZE F, LEFT; NEXGEN GSF POROUS FEMORAL LPS FLEX SIZE F, RIGHT; NEXGEN GSF POROUS FEMORAL LPS FLEX SIZE G, LEFT; and NEXGEN GSF POROUS FEMORAL LPS FLEX SIZE G, RIGHT). Provides increased flexion capability.","Part Number Range: 5752 and 5762.",,"11694","The low density polyethylene (LDPE) bag used to package implants adheres to the highly polished surface of the devices.",8/30/2013,"08/30/2013",11/6/2013,"11/06/2013"
"Devices",65799,"Ongoing","Zimmer, Inc.","Warsaw","IN","US","Voluntary: Firm Initiated","Letter"," Worldwide Distribution: US (nationwide) and countries of: Argentina, Australia, Bolivia, Brazil, Canada, Chile, China, Colombia, Costa Rica, Dominican Republic, Ecuador, El Salvador, Germany, Guatemala, Honduras, Hong Kong, India, Israel, Jamaica, Japan, Korea, Malaysia, Mexico, New Zealand, Nicaragua, Panama, Peru, Singapore, Taiwan, Thailand, and Venezula.","Z-0074-2014","Class II","NexGen Femoral Component (CR-FLEX GSF POR FEM, C-L; CR-FLEX GSF POR FEM, C-R; CR-FLEX GSF POR FEM, C-L MINUS; CR-FLEX GSF POR FEM, C-R MINUS; CR-FLEX GSF POR FEM, D-L; CR-FLEX GSF POR FEM, D-R CR-FLEX GSF POR FEM, D-L MINUS; CR-FLEX GSF POR FEM, D-R MINUS CR-FLEX GSF POR FEM, E-L; CR-FLEX GSF POR FEM, E-R; CR-FLEX GSF POR FEM, E-L MINUS; CR-FLEX GSF POR FEM, E-R MINUS; CR-FLEX GSF POR FEM, F-L ; CR-FLEX GSF POR FEM, F-R; CR-FLEX GSF POR FEM, F-L MINUS; CR-FLEX GSF POR FEM, F-R MINUS; CR-FLEX GSF POR FEM, G-L CR-FLEX GSF POR FEM, G-R; CR-FLEX GSF POR FEM, G-L MINUS CR-FLEX GSF POR FEM, G-R MINUS; NEXGEN GSF POROUS FEMORAL LPS FLEX SIZE C, LEFT; NEXGEN GSF POROUS FEMORAL LPS FLEX SIZE C, RIGHT; NEXGEN GSF POROUS FEMORAL LPS FLEX SIZE D, LEFT; NEXGEN GSF POROUS FEMORAL LPS FLEX SIZE D, RIGHT; LPS-FLEX GSF POR FEM, E-L; NEXGEN GSF POROUS FEMORAL LPS FLEX SIZE E, RIGHT; NEXGEN GSF POROUS FEMORAL LPS FLEX SIZE F, LEFT; NEXGEN GSF POROUS FEMORAL LPS FLEX SIZE F, RIGHT; NEXGEN GSF POROUS FEMORAL LPS FLEX SIZE G, LEFT; and NEXGEN GSF POROUS FEMORAL LPS FLEX SIZE G, RIGHT). Provides increased flexion capability.","Part Number Range: 5752 and 5762.",,"11694","The low density polyethylene (LDPE) bag used to package implants adheres to the highly polished surface of the devices.",8/30/2013,"08/30/2013",11/6/2013,"11/06/2013"
"Devices",65800,"Ongoing","Waldemar Link GmbH & Co. KG (Corp. Hq.)","Hamburg",,"DE","Voluntary: Firm Initiated","Letter","US Distribution to the state of Tennessee only.","Z-2068-2013","Class II","TRIAL STEM for MP(R) RECONSTRUCTION PROTHESIS, REF 99-0143/14, Stem size 01, prox. Stem dia. 14 mm, Length 250 mm, WALDEMAR LINK GmbH & CoKG, Barkhausenweg 10 . D . 22339 Hamburg","Lots: B208036, B225081",,"7 units","The trial stems were manufactured using the wrong design.",7/16/2013,"07/16/2013",9/4/2013,"09/04/2013"
"Devices",65800,"Ongoing","Waldemar Link GmbH & Co. KG (Corp. Hq.)","Hamburg",,"DE","Voluntary: Firm Initiated","Letter","US Distribution to the state of Tennessee only.","Z-2061-2013","Class II","TRIAL STEM for MP(R) RECONSTRUCTION PROTHESIS, REF 99-0142/14, Stem size 001, prox. Stem dia. 14 mm, Length 210 mm, WALDEMAR LINK GmbH & CoKG, Barkhausenweg 10 . D . 22339 Hamburg","Lots: B208031",,"5 units","The trial stems were manufactured using the wrong design.",7/16/2013,"07/16/2013",9/4/2013,"09/04/2013"
"Devices",65800,"Ongoing","Waldemar Link GmbH & Co. KG (Corp. Hq.)","Hamburg",,"DE","Voluntary: Firm Initiated","Letter","US Distribution to the state of Tennessee only.","Z-2078-2013","Class II","TRIAL STEM for MP(R) RECONSTRUCTION PROTHESIS, REF 99-0155/20, Stem size S-4, prox. Stem dia. 20 mm, Length 180 mm, WALDEMAR LINK GmbH & CoKG, Barkhausenweg 10 . D . 22339 Hamburg","Lots: B225118, B101171",,"8 units","The trial stems were manufactured using the wrong design.",7/16/2013,"07/16/2013",9/4/2013,"09/04/2013"
"Devices",65800,"Ongoing","Waldemar Link GmbH & Co. KG (Corp. Hq.)","Hamburg",,"DE","Voluntary: Firm Initiated","Letter","US Distribution to the state of Tennessee only.","Z-2080-2013","Class II","TRIAL STEM for MP(R) RECONSTRUCTION PROTHESIS, REF 99-0155/25, Stem size S-6, prox. Stem dia. 25 mm, Length 180 mm, WALDEMAR LINK GmbH & CoKG, Barkhausenweg 10 . D . 22339 Hamburg","Lots: B206025, B048090, B101172",,"8 units","The trial stems were manufactured using the wrong design.",7/16/2013,"07/16/2013",9/4/2013,"09/04/2013"
"Devices",65800,"Ongoing","Waldemar Link GmbH & Co. KG (Corp. Hq.)","Hamburg",,"DE","Voluntary: Firm Initiated","Letter","US Distribution to the state of Tennessee only.","Z-2079-2013","Class II","TRIAL STEM for MP(R) RECONSTRUCTION PROTHESIS, REF 99-0155/22, Stem size S-5, prox. Stem dia. 22.5 mm, Length 180 mm, WALDEMAR LINK GmbH & CoKG, Barkhausenweg 10 . D . 22339 Hamburg","Lots: B225115, B048089, B102030",,"9 units","The trial stems were manufactured using the wrong design.",7/16/2013,"07/16/2013",9/4/2013,"09/04/2013"
"Devices",65800,"Ongoing","Waldemar Link GmbH & Co. KG (Corp. Hq.)","Hamburg",,"DE","Voluntary: Firm Initiated","Letter","US Distribution to the state of Tennessee only.","Z-2067-2013","Class II","TRIAL STEM for MP(R) RECONSTRUCTION PROTHESIS, REF 99-0143/12, Stem size 0, prox. Stem dia. 12 mm, Length 250 mm, WALDEMAR LINK GmbH & CoKG, Barkhausenweg 10 . D . 22339 Hamburg","Lots: B048087, B225117",,"6 units","The trial stems were manufactured using the wrong design.",7/16/2013,"07/16/2013",9/4/2013,"09/04/2013"
"Devices",65800,"Ongoing","Waldemar Link GmbH & Co. KG (Corp. Hq.)","Hamburg",,"DE","Voluntary: Firm Initiated","Letter","US Distribution to the state of Tennessee only.","Z-2063-2013","Class II","TRIAL STEM for MP(R) RECONSTRUCTION PROTHESIS, REF 99-0142/18, Stem size 003, prox. Stem dia. 18 mm, Length 210 mm, WALDEMAR LINK GmbH & CoKG, Barkhausenweg 10 . D . 22339 Hamburg","Lots: B208032",,"5 units","The trial stems were manufactured using the wrong design.",7/16/2013,"07/16/2013",9/4/2013,"09/04/2013"
"Devices",65800,"Ongoing","Waldemar Link GmbH & Co. KG (Corp. Hq.)","Hamburg",,"DE","Voluntary: Firm Initiated","Letter","US Distribution to the state of Tennessee only.","Z-2073-2013","Class II","TRIAL STEM for MP(R) RECONSTRUCTION PROTHESIS, REF 99-0143/25, Stem size 06, prox. Stem dia. 25 mm, Length 250 mm, WALDEMAR LINK GmbH & CoKG, Barkhausenweg 10 . D . 22339 Hamburg","Lots: B209035, B225120",,"5 units","The trial stems were manufactured using the wrong design.",7/16/2013,"07/16/2013",9/4/2013,"09/04/2013"
"Devices",65800,"Ongoing","Waldemar Link GmbH & Co. KG (Corp. Hq.)","Hamburg",,"DE","Voluntary: Firm Initiated","Letter","US Distribution to the state of Tennessee only.","Z-2077-2013","Class II","TRIAL STEM for MP(R) RECONSTRUCTION PROTHESIS, REF 99-0155/18, Stem size S-3, prox. Stem dia. 18 mm, Length 180 mm, WALDEMAR LINK GmbH & CoKG, Barkhausenweg 10 . D . 22339 Hamburg","Lots: B225114, B051033, B103049",,"9 units","The trial stems were manufactured using the wrong design.",7/16/2013,"07/16/2013",9/4/2013,"09/04/2013"
"Devices",65800,"Ongoing","Waldemar Link GmbH & Co. KG (Corp. Hq.)","Hamburg",,"DE","Voluntary: Firm Initiated","Letter","US Distribution to the state of Tennessee only.","Z-2072-2013","Class II","TRIAL STEM for MP(R) RECONSTRUCTION PROTHESIS, REF 99-0143/22, Stem size 05, prox. Stem dia. 22.5 mm, Length 250 mm, WALDEMAR LINK GmbH & CoKG, Barkhausenweg 10 . D . 22339 Hamburg","Lots: B209034, B225123",,"4 units","The trial stems were manufactured using the wrong design.",7/16/2013,"07/16/2013",9/4/2013,"09/04/2013"
"Devices",65800,"Ongoing","Waldemar Link GmbH & Co. KG (Corp. Hq.)","Hamburg",,"DE","Voluntary: Firm Initiated","Letter","US Distribution to the state of Tennessee only.","Z-2069-2013","Class II","TRIAL STEM for MP(R) RECONSTRUCTION PROTHESIS, REF 99-0143/16, Stem size 02, prox. Stem dia. 16 mm, Length 250 mm, WALDEMAR LINK GmbH & CoKG, Barkhausenweg 10 . D . 22339 Hamburg","Lots: B226103, B051034",,"9 units","The trial stems were manufactured using the wrong design.",7/16/2013,"07/16/2013",9/4/2013,"09/04/2013"
"Devices",65800,"Ongoing","Waldemar Link GmbH & Co. KG (Corp. Hq.)","Hamburg",,"DE","Voluntary: Firm Initiated","Letter","US Distribution to the state of Tennessee only.","Z-2074-2013","Class II","TRIAL STEM for MP(R) RECONSTRUCTION PROTHESIS, REF 99-0155/12, Stem size S-0, prox. Stem dia. 12 mm, Length 180 mm, WALDEMAR LINK GmbH & CoKG, Barkhausenweg 10 . D . 22339 Hamburg","Lots: B208037, B225126",,"5 units","The trial stems were manufactured using the wrong design.",7/16/2013,"07/16/2013",9/4/2013,"09/04/2013"
"Devices",65800,"Ongoing","Waldemar Link GmbH & Co. KG (Corp. Hq.)","Hamburg",,"DE","Voluntary: Firm Initiated","Letter","US Distribution to the state of Tennessee only.","Z-2071-2013","Class II","TRIAL STEM for MP(R) RECONSTRUCTION PROTHESIS, REF 99-0143/20, Stem size 04, prox. Stem dia. 20 mm, Length 250 mm, WALDEMAR LINK GmbH & CoKG, Barkhausenweg 10 . D . 22339 Hamburg","Lots: B209033, B225119",,"5 units","The trial stems were manufactured using the wrong design.",7/16/2013,"07/16/2013",9/4/2013,"09/04/2013"
"Devices",65800,"Ongoing","Waldemar Link GmbH & Co. KG (Corp. Hq.)","Hamburg",,"DE","Voluntary: Firm Initiated","Letter","US Distribution to the state of Tennessee only.","Z-2076-2013","Class II","TRIAL STEM for MP(R) RECONSTRUCTION PROTHESIS, REF 99-0155/16, Stem size S-2, prox. Stem dia. 16 mm, Length 180 mm, WALDEMAR LINK GmbH & CoKG, Barkhausenweg 10 . D . 22339 Hamburg","Lots: B225116, B128075",,"6 units","The trial stems were manufactured using the wrong design.",7/16/2013,"07/16/2013",9/4/2013,"09/04/2013"
"Devices",65800,"Ongoing","Waldemar Link GmbH & Co. KG (Corp. Hq.)","Hamburg",,"DE","Voluntary: Firm Initiated","Letter","US Distribution to the state of Tennessee only.","Z-2062-2013","Class II","TRIAL STEM for MP(R) RECONSTRUCTION PROTHESIS, REF 99-0142/16, Stem size 002, prox. Stem dia. 16 mm, Length 210 mm, WALDEMAR LINK GmbH & CoKG, Barkhausenweg 10 . D . 22339 Hamburg","Lots: B226105, B128103",,"6 units","The trial stems were manufactured using the wrong design.",7/16/2013,"07/16/2013",9/4/2013,"09/04/2013"
"Devices",65800,"Ongoing","Waldemar Link GmbH & Co. KG (Corp. Hq.)","Hamburg",,"DE","Voluntary: Firm Initiated","Letter","US Distribution to the state of Tennessee only.","Z-2070-2013","Class II","TRIAL STEM for MP(R) RECONSTRUCTION PROTHESIS, REF 99-0143/18, Stem size 03, prox. Stem dia. 18 mm, Length 250 mm, WALDEMAR LINK GmbH & CoKG, Barkhausenweg 10 . D . 22339 Hamburg","Lots: B208089, B225125",,"5 units","The trial stems were manufactured using the wrong design.",7/16/2013,"07/16/2013",9/4/2013,"09/04/2013"
"Devices",65800,"Ongoing","Waldemar Link GmbH & Co. KG (Corp. Hq.)","Hamburg",,"DE","Voluntary: Firm Initiated","Letter","US Distribution to the state of Tennessee only.","Z-2075-2013","Class II","TRIAL STEM for MP(R) RECONSTRUCTION PROTHESIS, REF 99-0155/14, Stem size S-1, prox. Stem dia. 14 mm, Length 180 mm, WALDEMAR LINK GmbH & CoKG, Barkhausenweg 10 . D . 22339 Hamburg","Lots: B225082, B126052",,"6 units","The trial stems were manufactured using the wrong design.",7/16/2013,"07/16/2013",9/4/2013,"09/04/2013"
"Devices",65800,"Ongoing","Waldemar Link GmbH & Co. KG (Corp. Hq.)","Hamburg",,"DE","Voluntary: Firm Initiated","Letter","US Distribution to the state of Tennessee only.","Z-2060-2013","Class II","TRIAL STEM for MP(R) RECONSTRUCTION PROTHESIS, REF 99-0142/12, Stem size 00, prox. Stem dia. 12 mm, Length 210 mm, WALDEMAR LINK GmbH & CoKG, Barkhausenweg 10 . D . 22339 Hamburg","Lots: B208030, B225121",,"4 units","The trial stems were manufactured using the wrong design.",7/16/2013,"07/16/2013",9/4/2013,"09/04/2013"
"Devices",65800,"Ongoing","Waldemar Link GmbH & Co. KG (Corp. Hq.)","Hamburg",,"DE","Voluntary: Firm Initiated","Letter","US Distribution to the state of Tennessee only.","Z-2065-2013","Class II","TRIAL STEM for MP(R) RECONSTRUCTION PROTHESIS, REF 99-0142/22, Stem size 005, prox. Stem dia. 22.5 mm, Length 210 mm, WALDEMAR LINK GmbH & CoKG, Barkhausenweg 10 . D . 22339 Hamburg","Lots: B208034",,"5 units","The trial stems were manufactured using the wrong design.",7/16/2013,"07/16/2013",9/4/2013,"09/04/2013"
"Devices",65800,"Ongoing","Waldemar Link GmbH & Co. KG (Corp. Hq.)","Hamburg",,"DE","Voluntary: Firm Initiated","Letter","US Distribution to the state of Tennessee only.","Z-2066-2013","Class II","TRIAL STEM for MP(R) RECONSTRUCTION PROTHESIS, REF 99-0142/25, Stem size 006, prox. Stem dia. 25 mm, Length 210 mm, WALDEMAR LINK GmbH & CoKG, Barkhausenweg 10 . D . 22339 Hamburg","Lots: B208035",,"5 units","The trial stems were manufactured using the wrong design.",7/16/2013,"07/16/2013",9/4/2013,"09/04/2013"
"Devices",65800,"Ongoing","Waldemar Link GmbH & Co. KG (Corp. Hq.)","Hamburg",,"DE","Voluntary: Firm Initiated","Letter","US Distribution to the state of Tennessee only.","Z-2064-2013","Class II","TRIAL STEM for MP(R) RECONSTRUCTION PROTHESIS, REF 99-0142/20, Stem size 004, prox. Stem dia. 20 mm, Length 210 mm, WALDEMAR LINK GmbH & CoKG, Barkhausenweg 10 . D . 22339 Hamburg","Lots: B208033",,"5 units","The trial stems were manufactured using the wrong design.",7/16/2013,"07/16/2013",9/4/2013,"09/04/2013"
"Food",65801,"Ongoing","Giant Eagle","Pittsburgh","PA","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Giant Eagle retail stores in 4 states.","F-1790-2013","Class II","Giant Eagle Candy Place Chocolate Covered Peanuts NET WT. 5 OZ, UPC code 3003404313 This product was packaged in a facility that also processes peanuts, nuts, milk products, soy, wheat, sesame seeds, whey and eggs. Distributed By: Giant Eagle, Inc. Pittsburgh, PA 15328-2809","All codes",".","Unknown","The firm has issued a recall on Giant Eagle Candy Place Chocolate Covered Peanuts with UPC 3003404313. The product has whey in the ingredients and the label does not clearly state that there is a milk allergen. (only whey is listed in the ingredient statement). ",7/24/2013,"07/24/2013",8/14/2013,"08/14/2013"
"Drugs",65803,"Ongoing","Hi-Tech Pharmacal Co., Inc.","Amityville","NY","US","Voluntary: Firm Initiated","Letter","Nationwide and Puerto Rico","D-888-2013","Class III","Clobetasol Propionate Cream, USP, 0.05%, 15 grams, Rx only, Hi-Tech PHARMACAL label, Hi-Tech Pharmacal, Co., Inc., Amityville, NY 11701, NDC 50383-267-15 --- For dermatologic use only. Product is packaged into tubes and then placed into unit cartons.","Batch/Lot 619442, exp. 01/2015",,"58,812 tubes","Labeling: Label Mix-up; some cartons labeled as Clobetasol Propionate Cream USP contain tubes labeled as Clobetasol Propionate Gel USP. The actual product in the tube is Clobetasol Propionate Cream USP",7/25/2013,"07/25/2013",8/21/2013,"08/21/2013"
"Food",65804,"Ongoing","Tortilleria Lupita, Inc.","Oklahoma City","OK","US","Voluntary: Firm Initiated","Visit","OK","F-1800-2013","Class II","Tortillas Lupita White Corn Tortillas, Manufactured by Tortilleria Lupita, 235 SW 25th St, Oklahoma City, OK 73109","Flour tortillas packaged with corn tortilla label on 07/24/13.",,"6 cases","The product is being recalled for undeclared wheat. The flour tortillas were mislabeled as corn tortillas.",7/24/2013,"07/24/2013",8/21/2013,"08/21/2013"
"Devices",65805,"Ongoing","Carestream Health, Inc.","Rochester","NY","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution - US (nationwide) including the states of New York, Massachusetts, Pennsylvania, Illinois, Texas, California and Louisiana., and the countries of Australia, Canada, Finland, Italy, Switzerland and United Kingdom.","B-2334-13","Class III","Cornea","2010161C; 2010162C",,"2 corneas","Human corneas, recovered from a donor whose donor eligibility determination failed to ensure that the donor was free from risk factors for, and clinical evidence of infection due to relevant communicable disease agents and diseases, were distributed. ",7/13/2013,"07/13/2013",11/6/2013,"11/06/2013"
"Devices",65805,"Ongoing","Carestream Health, Inc.","Rochester","NY","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution - US (nationwide) including the states of New York, Massachusetts, Pennsylvania, Illinois, Texas, California and Louisiana., and the countries of Australia, Canada, Finland, Italy, Switzerland and United Kingdom.","Z-0090-2014","Class II","DRX Revolution Mobile X-Ray System, Model DRXR-1, Verona Street Rochester, NY 14608 Catalog Numbers 1019397, 1023415, 1023423 --- Made in USA by Carestream Health, Inc. 150 The device is designed to perform radiographic x-ray examinations on all pediatric and adult patients, in all patient treatment areas.","Serial numbers: U.S. - 134,152,173,174,200,205,222,312,349,353,412, Worldwide Serial numbers: 469, 445, 306, 410, 453, 204, 483, 300, 171, 218",,"23 units installed total (11 domestically & 12 internationally)","During an audit, Carestream discovered a DRX-1 System that captured an image which displayed an artifact. This issue was discovered in manufacturing. It occurs when the DRX product console software is updated to v5.6b software and the detector is not calibrated before use.",7/26/2013,"07/26/2013",11/6/2013,"11/06/2013"
"Devices",65806,"Ongoing","Siemens Healthcare Diagnostics, Inc","East Walpole","MA","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution - USA including AL, AR, AZ, CA, CO, CT, DE, FL, GA, IA, ID, IL, IN, KS, KY, LA, MA,MD, ME, MI, MN, MO, MS, MT, NC, NH, NJ, NM, NV, NY, OH, OK, OR, PA, PR, RI, SC, TN, TX, UT, VA, VT, WA, WI, WV, and WY. Internationally to Canada and Mexico.","Z-2169-2013","Class II","ADVIA Centaur Folate (100 Tests), SMN 10310308, Cat No. 06367974 In vitro diagnostic use in the quantitative determination of folate in serum or red blood cells. ","22288218, 22296218, 222907218",".","3114","Calibration failures and/or significant negative shifts in quality control (QC) and patient results. ",7/25/2013,"07/25/2013",9/18/2013,"09/18/2013"
"Devices",65806,"Ongoing","Siemens Healthcare Diagnostics, Inc","East Walpole","MA","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution - USA including AL, AR, AZ, CA, CO, CT, DE, FL, GA, IA, ID, IL, IN, KS, KY, LA, MA,MD, ME, MI, MN, MO, MS, MT, NC, NH, NJ, NM, NV, NY, OH, OK, OR, PA, PR, RI, SC, TN, TX, UT, VA, VT, WA, WI, WV, and WY. Internationally to Canada and Mexico.","Z-2170-2013","Class II","ADVIA Centaur Folate (500 Tests) SMN 10325366, Cat No. 06891541 In vitro diagnostic use in the quantitative determination of folate in serum or red blood cells. ","22289218, 22297218, 22535218",".","2840","Calibration failures and/or significant negative shifts in quality control (QC) and patient results. ",7/25/2013,"07/25/2013",9/18/2013,"09/18/2013"
"Devices",65806,"Ongoing","Siemens Healthcare Diagnostics, Inc","East Walpole","MA","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution - USA including AL, AR, AZ, CA, CO, CT, DE, FL, GA, IA, ID, IL, IN, KS, KY, LA, MA,MD, ME, MI, MN, MO, MS, MT, NC, NH, NJ, NM, NV, NY, OH, OK, OR, PA, PR, RI, SC, TN, TX, UT, VA, VT, WA, WI, WV, and WY. Internationally to Canada and Mexico.","Z-2172-2013","Class II","ADVIA Centaur Folate (2500 tests), REF SMN 10340209, Cat No. 09132781 In vitro diagnostic use in the quantitative determination of folate in serum or red blood cells. ","22299218",".","44","Calibration failures and/or significant negative shifts in quality control (QC) and patient results. ",7/25/2013,"07/25/2013",9/18/2013,"09/18/2013"
"Devices",65806,"Ongoing","Siemens Healthcare Diagnostics, Inc","East Walpole","MA","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution - USA including AL, AR, AZ, CA, CO, CT, DE, FL, GA, IA, ID, IL, IN, KS, KY, LA, MA,MD, ME, MI, MN, MO, MS, MT, NC, NH, NJ, NM, NV, NY, OH, OK, OR, PA, PR, RI, SC, TN, TX, UT, VA, VT, WA, WI, WV, and WY. Internationally to Canada and Mexico.","Z-2171-2013","Class II","ADVIA Centaur Folate (500 tests), REF SMN 10331250, Cat No. 00203473 In vitro diagnostic use in the quantitative determination of folate in serum or red blood cells. ","22298218",".","488","Calibration failures and/or significant negative shifts in quality control (QC) and patient results. ",7/25/2013,"07/25/2013",9/18/2013,"09/18/2013"
"Drugs",65807,"Ongoing","West-Ward Pharmaceutical Corp.","Eatontown","NJ","US","Voluntary: Firm Initiated","Letter","Nationwide","D-853-2013","Class II","Lisinopril Tablets, USP, 2.5 mg, Rx only, packaged in a) 100-count bottles (NDC 0143-1265-01) and b) 1000-count bottles (NDC 0143-1265-10), Manufactured by: West-ward Pharmaceutical Corp., Eatontown, N.J. 07724; and c) 1000-count bottles (NDC 24658-240-10), Manufactured for: Blu Pharmaceuticals, Franklin, KY 42134; Manufactured By: West-ward Pharmaceutical Corp., Eatontown, N.J. 07724.","Lot #: a) 68679A, 68679C, Exp 01/15; 64456A, Exp 04/15; 68980A, Exp 05/15; 69234A, 69235A, Exp 07/15; 69607A, Exp 11/15; 69609C, 69835A, Exp 01/16; b) 64455B, Exp 08/13; 64456C, Exp 04/14; 64457A, Exp 10/14, 68679B, 68680A, Exp 01/15; 68980B, Exp 05/15; 69607B, 69608A, Exp 11/15; 69609B, Exp 01/16; c) 64455A, 64455C, 64455D, Exp 08/13; 64456B, Exp 04/14; 64457B, Exp 10/14; 68680B, Exp 01/15; 68980C, 68981A, Exp 05/15; 69608B, Exp 11/15; 69609A, Exp 01/16; 70169A, Exp 05/16 ",".","51,704 bottles","Failed Impurities/Degradation Specifications: Out of Specification results for Individual Other Unknown Related Compounds were obtained at the 48 month time-point.",7/30/2013,"07/30/2013",8/14/2013,"08/14/2013"
"Food",65808,"Ongoing","Gold Star Smoked Fish Corp.","Brooklyn","NY","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Florida, Illinois, Maine, Maryland, Massachusetts, Michigan, Minnesota, New York, Ohio, Oregon and Virginia","F-1807-2013","Class I","RYBACKA WIES brand HERRING FILLETS IN OIL (MATJES SLEDZ W OLEJU), Net Wt. 17.6 oz. (500g), UPC 0 21143 24122 8, Distributed By Gold Star, Inc., Brooklyn, NY 11231 --- The product is vacuum packed in a sealed plastic package.","Expiration Date 103113 (stamped on the back of the package) ",,"30 cases (8 x 17.6 oz./500 grams)","The product was found to be contaminated with Listeria monocytogenes based on sampling and analysis by New York State Department of Agriculture & Markets.",7/25/2013,"07/25/2013",8/21/2013,"08/21/2013"
"Food",65809,"Ongoing","Craft Brewers Alliance Inc.","Portland","OR","US","Voluntary: Firm Initiated","E-Mail","Distributed in California, Oregon, Washington","F-1785-2013","Class III","Square Mile Spur & Vine Hopped Apple Cider is hopped hard cider is in liquid form and is an alcoholic beverage. It is packaged in 22 fl oz glass bottles shipped in a corrugated master carton that contains 12 bottles. Individual bottle is sold at retail stores. UPC codes case: 7-02770-04912-0 UPC Bottle: 7-02770-24910-0 PDCN code: CAB12 ","Products packaged on or before May 15, 2013. Individual bottle does not have any codes. ",,"2699 cases/12 bottles/22 fl oz.","Square Mile Spur & Vine Hopped Apple Cider is recalled because bottles may burst.",7/16/2013,"07/16/2013",8/21/2013,"08/21/2013"
"Food",65809,"Ongoing","Craft Brewers Alliance Inc.","Portland","OR","US","Voluntary: Firm Initiated","E-Mail","Distributed in California, Oregon, Washington","F-1784-2013","Class III","Square Mile Original Hard Apple Cider is hard cider is in liquid form and is an alcoholic beverage. It is packaged in 22 fl oz glass bottles shipped in a corrugated master carton that contains 12 bottles. Individual bottle is sold at retail stores. UPC codes case: 7-02770-04812-0; UPC Bottle: 7-02770-24810-0; PDCN code: CAA12.","Products packaged on or before May 15, 2013. Individual bottle does not have any codes. ",,"3053 cases/12 bottles/22 oz. fl.","Square Mile Original Hard Apple Cider is recalled because bottles may burst.",7/16/2013,"07/16/2013",8/21/2013,"08/21/2013"
"Devices",65810,"Ongoing","Micro Therapeutics Inc, Dba Ev3 Neurovascular","Irvine","CA","US","Voluntary: Firm Initiated","Letter","US Distribution including the states of AZ, KY, MO, NC, GA, WI, OR, FL, NY, CA, IL, TN, NV, TX, CO, MA, IA, UT and VA.","Z-2045-2013","Class II","Pipeline Embolization Device (PED) The Pipeline Embolization Device is indicated for the endovascular treatment of adults (22 years of age and older) with large or giant wide-necked intracranial aneurysms in the internal carotid artery from the petrous to the superior hypophyseal segments.","Model/Lot Numbers: FA-71400-25 / 9747602 FA-77350-18 / 9749412 FA-77400-20 / 9759088 FA-71500-35 / 9747604 FA-77375-16 / 9744487 FA-77425-16 / 9752788 FA-77300-16 / 9757068 FA-77375-20 / 9757065 FA-77425-20 / 9744123 FA-77325-14 / 9759141 FA-77400-14 / 9757233 FA-77425-20 / 9752438 FA-77325-16 / 9753034 FA-77400-14 / 9768698 FA-77450-18 / 9753033 FA-77325-16 / 9757024 FA-77400-16 / 9743468 FA-77475-20 / 9752787 FA-77325-18 / 9759560 FA-77400-18 / 9751579 FA-77500-20 / 9750678 FA-77350-16 / 9752785 FA-77400-20 / 9755707",,"62 units","Covidien Neurovascular has initiated the recall of several lots of Pipeline Embolization Device (PED) because the Instructions For Use (IFU) do not include the following contraindication: Patients in whom a pre-existing stent is in place in the parent artery at the target aneurysm location. Additionally, the designation of aspirin and clopidogrel was missing from the following contraindication ''Patients in whom dual antiplatelet therapy (aspirin and clopidorel) is contraindicated.''",7/19/2013,"07/19/2013",9/4/2013,"09/04/2013"
"Food",65811,"Ongoing","Tortilleria Lupita, Inc.","Oklahoma City","OK","US","Voluntary: Firm Initiated","Visit","OK","F-1863-2013","Class II","Tortillas Lupita Flour Tortillas, Net Wt. 23oz, Manufactured By Tortilleria Lupita, 235 SW 25th St., Oklahoma City, OK 73109","All product still on the retail store shelf.",".","154 cases","The product is being recalled for undeclared soy lecithin and soybean oil.",7/25/2013,"07/25/2013",9/11/2013,"09/11/2013"
"Devices",65812,"Ongoing","Siemens Medical Solutions USA, Inc.","Mountain View","CA","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution - US (nationwide) including the states of IL, PA, AZ, OR, OH, NY, CO, TX and CA., and the countries of France, Germany, Japan, Portugal, Saudi Arabia, Taiwan and Turkey.","Z-0052-2014","Class II","Acuson SC2000 volume imaging ultrasound systems at software version 3.0. Mfg name: Siemens Medical Solutions USA, Inc. Mountain View, CA 94043 Medical Device for human use. Ultrasound imaging system used to measure anatomical structures and calculation packages that provide information to the clinician for clinical diagnosis purposes.","Model# 10433816 Software Version 3.0 Serial#'s: 401239 401189 401214 400416 400599 400600 401254 401260 401259 401161 400836 401111 401290 400641 401116 401236 401245 401241 401255 401361 400141 401108 401109 401213 400675 400882",".","26 units","Software issue results in inaccurate 3D image may result in ablation in wrong location.",7/10/2013,"07/10/2013",10/30/2013,"10/30/2013"
"Food",65814,"Ongoing","Lipari Foods, Inc.","Warren","MI","US","Voluntary: Firm Initiated","Telephone","Ohio, Michigan, Minnesota, West Virginia, Kentucky, Pennsylvania, Illinois, and Indiana","F-1783-2013","Class I","WHOLEY Shrimp, Farm Raised, Cooked, Peeled Deveined, Tail on, Ingredients: Shrimp, Salt and Sodium Tripolyphosphate..., ,Net Wt 1 LB (16 oz) , 399103 UPC Number: 094776074556; Product of Indonesia","lot No 30081, 10081, 70081, 70084, 30084, and 00884",,"1336 cases","Lipari Foods of Warren, MI is recalling Wholey peeled, cooked, tail-on 31/40 count shrimp, because it has the potential to be contaminated with Salmonella, an organism which can cause serious and sometimes fatal infections in young children, frail or elderly people, and others with weakened immune systems.",7/26/2013,"07/26/2013",8/7/2013,"08/07/2013"
"Biologics",65815,"Terminated","Blood Assurance Inc","Chattanooga","TN","US","Voluntary: Firm Initiated","FAX","Tennessee; New York","B-2437-13","Class III","Blood and Blood Products for Reprocessing","W043209035415; ",".","1","Blood products, collected from a donor in whom donor suitability was not adequately determined, were distributed.",6/24/2013,"06/24/2013",10/30/2013,"10/30/2013"
"Biologics",65815,"Terminated","Blood Assurance Inc","Chattanooga","TN","US","Voluntary: Firm Initiated","FAX","Tennessee; New York","B-2436-13","Class II","Red Blood Cells Leukocytes Reduced","W043209035415; ",".","1","Blood products, collected from a donor in whom donor suitability was not adequately determined, were distributed.",6/24/2013,"06/24/2013",10/30/2013,"10/30/2013"
"Biologics",65815,"Terminated","Blood Assurance Inc","Chattanooga","TN","US","Voluntary: Firm Initiated","FAX","Tennessee; New York","B-2438-13","Class II","Platelets","W043209035415; ",".","1","Blood products, collected from a donor in whom donor suitability was not adequately determined, were distributed.",6/24/2013,"06/24/2013",10/30/2013,"10/30/2013"
"Biologics",65816,"Terminated"," Lions Eye Bank For Long Island ","Valley Stream","NY","US","Voluntary: Firm Initiated","Letter","New York","B-2334-13","Class III","Cornea","2010161C; 2010162C",,"2 corneas","Human corneas, recovered from a donor whose donor eligibility determination failed to ensure that the donor was free from risk factors for, and clinical evidence of infection due to relevant communicable disease agents and diseases, were distributed. ",7/13/2013,"07/13/2013",11/6/2013,"11/06/2013"
"Biologics",65817,"Terminated"," Lions Eye Bank For Long Island ","Valley Stream","NY","US","Voluntary: Firm Initiated","Letter","New York","B-2322-13","Class III","Cornea","201051C; 201052C",,"2 corneas","Human corneas, recovered from a donor whose donor eligibility determination failed to ensure that the donor was free from risk factors for, and clinical evidence of infection due to relevant communicable disease agents and diseases, were distributed. ",7/13/2013,"07/13/2013",11/6/2013,"11/06/2013"
"Biologics",65817,"Terminated"," Lions Eye Bank For Long Island ","Valley Stream","NY","US","Voluntary: Firm Initiated","Letter","New York","B-2322-13","Class III","Cornea","201051C; 201052C",,"2 corneas","Human corneas, recovered from a donor whose donor eligibility determination failed to ensure that the donor was free from risk factors for, and clinical evidence of infection due to relevant communicable disease agents and diseases, were distributed. ",7/13/2013,"07/13/2013",11/6/2013,"11/06/2013"
"Biologics",65818,"Terminated"," Lions Eye Bank For Long Island ","Valley Stream","NY","US","Voluntary: Firm Initiated","Letter","New York","B-2323-13","Class III","Cornea","2009169C; 2009170C",,"2 corneas","Human corneas, recovered from a donor whose donor eligibility determination failed to ensure that the donor was free from risk factors for, and clinical evidence of infection due to relevant communicable disease agents and diseases, were distributed. ",7/13/2013,"07/13/2013",11/6/2013,"11/06/2013"
"Devices",65819,"Ongoing","ASO, LLC","Sarasota","FL","US","Voluntary: Firm Initiated","Letter","Nationwide Distribution including FL, IA, IL, MI, NC, NY, OH, OR, PA, RI, TX, WA and WI.","Z-1894-2013","Class II","Premier Value Wound Closure Adhesive Surgical Tape Strips 30 strips 1/4 in. x 4 in. Sterile latex free UPC # 040986021558 Used to secure, close and support small cuts and wounds.","ASO Packaging Lot#s: 218620, 354840, 546660, 115451, 223771, 285451, 324201, 366061, 193702, 227822, 263592, 302572, 123313, 123293, 123303 123313, 123283, and 28955 ",".","Total 2,689,560 pouches (2 cards/pouch)","This recall has been initiated by Aspen Surgical Products, Inc., due to the inability to confirm sterility.",7/26/2013,"07/26/2013",8/14/2013,"08/14/2013"
"Devices",65819,"Ongoing","ASO, LLC","Sarasota","FL","US","Voluntary: Firm Initiated","Letter","Nationwide Distribution including FL, IA, IL, MI, NC, NY, OH, OR, PA, RI, TX, WA and WI.","Z-1889-2013","Class II","Discount Drug Mart Wound Closure Adhesive Surgical Tape Strips 30 strips 1/4 in. x 4 in. Sterile latex free UPC # 093351120374 Used to secure, close and support small cuts and wounds.","ASO Packaging Lot #: 208351",".","Total 2,689,560 pouches (2 cards/pouch)","This recall has been initiated by Aspen Surgical Products, Inc., due to the inability to confirm sterility.",7/26/2013,"07/26/2013",8/14/2013,"08/14/2013"
"Devices",65819,"Ongoing","ASO, LLC","Sarasota","FL","US","Voluntary: Firm Initiated","Letter","Nationwide Distribution including FL, IA, IL, MI, NC, NY, OH, OR, PA, RI, TX, WA and WI.","Z-1896-2013","Class II","Walgreens (''W'' and ''Well at Walgreens'') Wound Closure Adhesive Surgical Tape Strips 30 strips 1/4 in. x 4 in. Sterile latex free UPC # (''W'') 311917111728 item # 479241 UPC # (''Well at Walgreens'') 311917143354 item # 156744 Used to secure, close and support small cuts and wounds.","ASO Packaging Lot#s: 100253, 103163, 105082, 109110, 111711, 114813, 120250, 123273, 126652, 130303, 142072, 144902, 144912, 144932, 144942, 144952, 144962, 144982, 144992, 145002, 145012, 145022, 145032, 145042, 145052, 145062, 145412, 1453470, 154452, 158512, 163272, 168391, 184482, 190112, 191830, 204872, 214272, 223482, 225511, 225820, 234871, 235941, 237882, 238041, 242061, 248891, 264180, 267631, 270552, 271031, 280441, 283001, 290581, 291202, 297932, 306912, 312671, 316222, 320221, 322632, 324362, 324901, 329651, 334670, 338241, 368051, 390340, 473410, 481090, 517690, 532540, 549000, 558990, 28538, and 29020 ",".","Total 2,689,560 pouches (2 cards/pouch)","This recall has been initiated by Aspen Surgical Products, Inc., due to the inability to confirm sterility.",7/26/2013,"07/26/2013",8/14/2013,"08/14/2013"
"Devices",65819,"Ongoing","ASO, LLC","Sarasota","FL","US","Voluntary: Firm Initiated","Letter","Nationwide Distribution including FL, IA, IL, MI, NC, NY, OH, OR, PA, RI, TX, WA and WI.","Z-1890-2013","Class II","Duane Reade (DR) Wound Closure Adhesive Surgical Tape Strips 30 strips 1/4 in. x 4 in. Sterile latex free UPC # 639194043885 Used to secure, close and support small cuts and wounds.","ASO Packaging Lot #s: 175770 and 209340",".","Total 2,689,560 pouches (2 cards/pouch)","This recall has been initiated by Aspen Surgical Products, Inc., due to the inability to confirm sterility.",7/26/2013,"07/26/2013",8/14/2013,"08/14/2013"
"Devices",65819,"Ongoing","ASO, LLC","Sarasota","FL","US","Voluntary: Firm Initiated","Letter","Nationwide Distribution including FL, IA, IL, MI, NC, NY, OH, OR, PA, RI, TX, WA and WI.","Z-1893-2013","Class II","Meijer Wound Closure Adhesive Surgical Tape Strips 30 strips 1/4 in. x 4 in. Sterile latex free UPC # 719283595973 Used to secure, close and support small cuts and wounds.","ASO Packaging Lot #s: 123120 and 324880",".","Total 2,689,560 pouches (2 cards/pouch)","This recall has been initiated by Aspen Surgical Products, Inc., due to the inability to confirm sterility.",7/26/2013,"07/26/2013",8/14/2013,"08/14/2013"
"Devices",65819,"Ongoing","ASO, LLC","Sarasota","FL","US","Voluntary: Firm Initiated","Letter","Nationwide Distribution including FL, IA, IL, MI, NC, NY, OH, OR, PA, RI, TX, WA and WI.","Z-1891-2013","Class II","HEB Wound Closure Adhesive Surgical Tape Strips 30 strips 1/4 in. x 4 in. Sterile latex free UPC # 041220302536 Used to secure, close and support small cuts and wounds.","ASO Packaging Lot #s: 143560, 171871, 250861, 379061, 402860, 418910, 513820, and 544130",".","Total 2,689,560 pouches (2 cards/pouch)","This recall has been initiated by Aspen Surgical Products, Inc., due to the inability to confirm sterility.",7/26/2013,"07/26/2013",8/14/2013,"08/14/2013"
"Devices",65819,"Ongoing","ASO, LLC","Sarasota","FL","US","Voluntary: Firm Initiated","Letter","Nationwide Distribution including FL, IA, IL, MI, NC, NY, OH, OR, PA, RI, TX, WA and WI.","Z-1892-2013","Class II","Leader Wound Closure Adhesive Surgical Tape Strips 30 strips 1/4 in. x 4 in. Sterile latex free UPC # 096295114706 Used to secure, close and support small cuts and wounds.","ASO Packaging Lot #s: 114870, 321860, 386990, 474650, 386990, 223251, 237641, 328481, 228682, and 266542 ",".","Total 2,689,560 pouches (2 cards/pouch)","This recall has been initiated by Aspen Surgical Products, Inc., due to the inability to confirm sterility.",7/26/2013,"07/26/2013",8/14/2013,"08/14/2013"
"Devices",65819,"Ongoing","ASO, LLC","Sarasota","FL","US","Voluntary: Firm Initiated","Letter","Nationwide Distribution including FL, IA, IL, MI, NC, NY, OH, OR, PA, RI, TX, WA and WI.","Z-1888-2013","Class II","CVS Pharmacy Wound Closure Adhesive Surgical Tape Strips 30 strips 1/4 in. x 4 in. Sterile latex free UPC # 050428102909 item # 409170 Used to secure, close and support small cuts and wounds.","ASO Packaging Lot #s: 101173, 102040, 1020631, 111450, 112092, 112102, 112623, 114833, 114843, 114853, 114863, 114873, 114883, 114843, 114853, 114863, 114873, 114883, 120343, 123542, 124890, 126582, 130313, 130973, 136592, 141962, 145172, 149421, 149742, 149752, 149762, 149772, 149992, 154192, 158761, 165422, 169961, 170232, 172572, 177182, 180302, 183821, 193150, 193542, 198062, 204742,207610, 228372, 231481, 233652, 234272, 238871, 245421, 259031, 265030, 310081, 312060, 318012, 318311, 324352, 324631, 335661, 345082, 363801.833711, 384420, 407470, 437940, 471090, 511940, 525910, 545400, 552850, 28781, 28982, 29040, and 29041",".","Total 2,689,560 pouches (2 cards/pouch)","This recall has been initiated by Aspen Surgical Products, Inc., due to the inability to confirm sterility.",7/26/2013,"07/26/2013",8/14/2013,"08/14/2013"
"Devices",65819,"Ongoing","ASO, LLC","Sarasota","FL","US","Voluntary: Firm Initiated","Letter","Nationwide Distribution including FL, IA, IL, MI, NC, NY, OH, OR, PA, RI, TX, WA and WI.","Z-1895-2013","Class II","TopCare Wound Closure Adhesive Surgical Tape Strips 30 strips 1/4 in. x 4 in. Sterile latex free UPC # 036800165854 Used to secure, close and support small cuts and wounds. ","ASO Packaging Lot#s: 121860, 141870, 145000, and 147910 ",".","Total 2,689,560 pouches (2 cards/pouch)","This recall has been initiated by Aspen Surgical Products, Inc., due to the inability to confirm sterility.",7/26/2013,"07/26/2013",8/14/2013,"08/14/2013"
"Food",65820,"Terminated","Green Core","Jacksonville","FL","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","VA, TN, GA, NC, SC, FL","F-1845-2013","Class III","Okami Fully Cooked Wild-Caught Lobster Roll with Avocado, in a 7oz plastic tray with lid, to be stored less than or equal to 40 degrees F.","07/15/13 thru 07/19/13 UPC's: 663603141428",".","233 individual packs","The product was misbranded. Raw lobster meat (instead of cooked lobster meat) was used.",7/10/2013,"07/10/2013",8/28/2013,"08/28/2013"
"Devices",65821,"Ongoing","Codman & Shurtleff, Inc.","Raynham","MA","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution - USA Nationwide in the states of NJ, NC, TX, FL and in the countries of Austria, Belgium, Egypt, Germany, Greece, Ireland, Israel, Italy, Luxemborg, Portugal, Russia, Saudi Arabia, Slovenia, Spain, Sweden, Switzerland, Turkey, and UK.","Z-2297-2013","Class I"," MedStream Refill Kit (6 units), EMEA: 91-4290 Product Usage: The Medstream programmable pump is intended for the intrathecal delivery of Baclofen in the US market and for the intrathecal delivery of Morphine or Baclofen in the EMEA market. Refill Kits- are intended for use in the filling and re-filling of the Medstream pump reservoir. ","OUS: Per recall strategy ",,"832 units","Drug flow rates exceeding programmed flow rates.",8/13/2013,"08/13/2013",10/9/2013,"10/09/2013"
"Devices",65821,"Ongoing","Codman & Shurtleff, Inc.","Raynham","MA","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution - USA Nationwide in the states of NJ, NC, TX, FL and in the countries of Austria, Belgium, Egypt, Germany, Greece, Ireland, Israel, Italy, Luxemborg, Portugal, Russia, Saudi Arabia, Slovenia, Spain, Sweden, Switzerland, Turkey, and UK.","Z-2298-2013","Class I","MedStream Refill Kit, U.S (6 units): 91-4288 Product Usage: The Medstream programmable pump is intended for the intrathecal delivery of Baclofen in the US market and for the intrathecal delivery of Morphine or Baclofen in the EMEA market. Refill Kits- are intended for use in the filling and re-filling of the Medstream pump reservoir. ","N/A",,"0 - product used for internal training purposes only","Drug flow rates exceeding programmed flow rates.",8/13/2013,"08/13/2013",10/9/2013,"10/09/2013"
"Devices",65821,"Ongoing","Codman & Shurtleff, Inc.","Raynham","MA","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution - USA Nationwide in the states of NJ, NC, TX, FL and in the countries of Austria, Belgium, Egypt, Germany, Greece, Ireland, Israel, Italy, Luxemborg, Portugal, Russia, Saudi Arabia, Slovenia, Spain, Sweden, Switzerland, Turkey, and UK.","Z-2295-2013","Class I","MedStream Refill Kit, U.S: 91-4287 Product Usage: The Medstream programmable pump is intended for the intrathecal delivery of Baclofen in the US market and for the intrathecal delivery of Morphine or Baclofen in the EMEA market. Refill Kits- are intended for use in the filling and re-filling of the Medstream pump reservoir. ","Lot/Serial Number US: 13B090CT",,"5 units","Drug flow rates exceeding programmed flow rates.",8/13/2013,"08/13/2013",10/9/2013,"10/09/2013"
"Devices",65821,"Ongoing","Codman & Shurtleff, Inc.","Raynham","MA","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution - USA Nationwide in the states of NJ, NC, TX, FL and in the countries of Austria, Belgium, Egypt, Germany, Greece, Ireland, Israel, Italy, Luxemborg, Portugal, Russia, Saudi Arabia, Slovenia, Spain, Sweden, Switzerland, Turkey, and UK.","Z-2293-2013","Class I","MedStream Programmable Pump; 20ml - 91-4200US Product Usage: The Medstream programmable pump is intended for the intrathecal delivery of Baclofen in the US market and for the intrathecal delivery of Morphine or Baclofen in the EMEA market. Refill Kits- are intended for use in the filling and re-filling of the Medstream pump reservoir. ","Lot/Serial Number US: NMBJ7K, NMBJ5C ",,"2 units","Drug flow rates exceeding programmed flow rates.",8/13/2013,"08/13/2013",10/9/2013,"10/09/2013"
"Devices",65821,"Ongoing","Codman & Shurtleff, Inc.","Raynham","MA","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution - USA Nationwide in the states of NJ, NC, TX, FL and in the countries of Austria, Belgium, Egypt, Germany, Greece, Ireland, Israel, Italy, Luxemborg, Portugal, Russia, Saudi Arabia, Slovenia, Spain, Sweden, Switzerland, Turkey, and UK.","Z-2299-2013","Class I","MedStream Programmable Pump; 40ml Pump EMEA 91-4201 Product Usage: The Medstream programmable pump is intended for the intrathecal delivery of Baclofen in the US market and for the intrathecal delivery of Morphine or Baclofen in the EMEA market. Refill Kits- are intended for use in the filling and re-filling of the Medstream pump reservoir. ","OUS: Per recall strategy",,"369 units","Drug flow rates exceeding programmed flow rates.",8/13/2013,"08/13/2013",10/9/2013,"10/09/2013"
"Devices",65821,"Ongoing","Codman & Shurtleff, Inc.","Raynham","MA","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution - USA Nationwide in the states of NJ, NC, TX, FL and in the countries of Austria, Belgium, Egypt, Germany, Greece, Ireland, Israel, Italy, Luxemborg, Portugal, Russia, Saudi Arabia, Slovenia, Spain, Sweden, Switzerland, Turkey, and UK.","Z-2296-2013","Class I","MedStream Refill Kit (1 unit), EMEA: 91-4289 Product Usage: The Medstream programmable pump is intended for the intrathecal delivery of Baclofen in the US market and for the intrathecal delivery of Morphine or Baclofen in the EMEA market. Refill Kits- are intended for use in the filling and re-filling of the Medstream pump reservoir. ","OUS: Per recall strategy ",,"OUS: 2168 units","Drug flow rates exceeding programmed flow rates.",8/13/2013,"08/13/2013",10/9/2013,"10/09/2013"
"Devices",65821,"Ongoing","Codman & Shurtleff, Inc.","Raynham","MA","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution - USA Nationwide in the states of NJ, NC, TX, FL and in the countries of Austria, Belgium, Egypt, Germany, Greece, Ireland, Israel, Italy, Luxemborg, Portugal, Russia, Saudi Arabia, Slovenia, Spain, Sweden, Switzerland, Turkey, and UK.","Z-2300-2013","Class I","MedStream Programmable Pump; 20ml Pump EMEA 91-4200 Product Usage: The Medstream programmable pump is intended for the intrathecal delivery of Baclofen in the US market and for the intrathecal delivery of Morphine or Baclofen in the EMEA market. Refill Kits- are intended for use in the filling and re-filling of the Medstream pump reservoir. ","OUS: Per recall strategy",,"735 units","Drug flow rates exceeding programmed flow rates.",8/13/2013,"08/13/2013",10/9/2013,"10/09/2013"
"Devices",65821,"Ongoing","Codman & Shurtleff, Inc.","Raynham","MA","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution - USA Nationwide in the states of NJ, NC, TX, FL and in the countries of Austria, Belgium, Egypt, Germany, Greece, Ireland, Israel, Italy, Luxemborg, Portugal, Russia, Saudi Arabia, Slovenia, Spain, Sweden, Switzerland, Turkey, and UK.","Z-2294-2013","Class I","MedStream Programmable Pump; 40ml - 91-4201US Usage: The Medstream programmable pump is intended for the intrathecal delivery of Baclofen in the US market and for the intrathecal delivery of Morphine or Baclofen in the EMEA market. Refill Kits- are intended for use in the filling and re-filling of the Medstream pump reservoir. ","Lot/Serial Number US: NMBKB6, NMBKFF, NMBKC5, NMBKCF, NMBJ3K ",,"5 units","Drug flow rates exceeding programmed flow rates.",8/13/2013,"08/13/2013",10/9/2013,"10/09/2013"
"Devices",65822,"Ongoing","Fisher Scientific Co","Pittsburgh","PA","US","Voluntary: Firm Initiated","Letter","Nationwide and the country of Canada.","Z-1955-2013","Class II","Fisherbrand Sterile Swab, Calcium Alginate Fiber Tipped, Wood Applicator Swab 100 pouches/boxes, 10 boxes/case. Used in applying medications to or take specimens from a patient. ","Product code # 14-959-81, lot #61513, expiration date: 2014-08, and lot 8710, expiration date 2014-08. ",,"1230","The firm is recalling Fisherbrand Sterile Swabs due to 4 customer complaints reporting the presence of non-pathogenic organisms in two lots. The finding was confirmed in lot 61513 and lot 8710 is also being recalled as a precautionary measure.",6/5/2013,"06/05/2013",8/21/2013,"08/21/2013"
"Devices",65823,"Ongoing","Stelkast Co","Mcmurray","PA","US","Voluntary: Firm Initiated","Telephone","Nationwide Distribution including TX, VA, OK, and PA","Z-2136-2013","Class II","SC2316, Distal Femoral Augment with Screw Total knee replacement due to osteoarthritis, osteonecrosis, rheumatoid arthritis and/or post-traumatic degenerative problems and revision of failed previous reconstructions.","Part number SC2316-3-5 with lot number 22389-111609. Part number SC2316-4-5 with lot number 22587-111609. Part number SC2316-5-5 with lot number 23214-111609. ",".","11 ","The firm became aware of an incident relating to a breach of sterility in the sterility barrier packaging of SC2316, Distal Femoral Augment with Screw. ",6/24/2013,"06/24/2013",9/11/2013,"09/11/2013"
"Devices",65824,"Ongoing","Integra Limited","Plainsboro","NJ","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution - USA including Puerto Rico and the states of AZ, CA, FL, GA, IL, IN, KY, MA, MI, MS, NE, NM, NY, OH, PA, TN, TX, UT, VA, WA, WI and WV., and the countries of Spain, Singapore, South Africa, Canada, Libya,Pakistan and Cayman Islands.","Z-2056-2013","Class II","Integra Leyla Ball Joint Clamp, also as included in Leyla Table Mounting Hardware. The Leyla Retraction System, as part of the Ruggles brand of instruments is intended for use as a self-retaining retractor which is a self-locking device used to hold the edges of a wound open during neurosurgery.","Catalog Number R2383 and as a component of catalog number R2385, including all lot numbers date codes going back to January 2006. ",,"65","As a result of complaint investigations it was identified that there is a potential that the Leyla Ball Joint Clamp (R2383) may not provide the level of stability needed to maintain retraction in all cases.",7/17/2013,"07/17/2013",9/4/2013,"09/04/2013"
"Food",65825,"Ongoing","Johnson Brothers Liquor Company, Inc","Saint Paul","MN","US","Voluntary: Firm Initiated","E-Mail","AL, AZ, GA, IN,KY, MI, MO , NE, NV, NC, OH, SC.","F-1815-2013","Class II","Evviva Strawberry Spumante, UPC 84279-99138","UPC 84279-99138",".","1750 cases (12 bottles/case)","Evviva Fresh Peach Spumante and Evviva Strawberry Spumante are being recalled because they contain coloring ingredients not permitted for use in the United States.",7/24/2013,"07/24/2013",8/28/2013,"08/28/2013"
"Food",65825,"Ongoing","Johnson Brothers Liquor Company, Inc","Saint Paul","MN","US","Voluntary: Firm Initiated","E-Mail","AL, AZ, GA, IN,KY, MI, MO , NE, NV, NC, OH, SC.","F-1814-2013","Class II","Evviva Fresh Peach Spumante, UPC 84279-99137","UPC 84279-99137",".","1750 cases (12 bottles/case)","Evviva Fresh Peach Spumante and Evviva Strawberry Spumante are being recalled because they contain coloring ingredients not permitted for use in the United States.",7/24/2013,"07/24/2013",8/28/2013,"08/28/2013"
"Drugs",65826,"Ongoing","Teva Pharmaceuticals USA, Inc.","Sellersville","PA","US","Voluntary: Firm Initiated","Letter","Nationwide and Puerto Rico","D-842-2013","Class II","Terazosin Hydrochloride Capsules,10 mg, 100-count bottle, Rx only, Manufactured for Teva Pharmaceuticals USA, Sellersville, PA 18960, NDC 0093-4339-01","Lot # N07321, Exp 6/14",".","6267 bottles","Labeling -label error on declared strength: unopened, sealed bottle of Terazosin Hydrochloride (HCl) 10mg Capsules contained Terazosin HCl 5 mg Capsules",7/23/2013,"07/23/2013",8/14/2013,"08/14/2013"
"Devices",65828,"Ongoing","OrthoPediatrics Corp","Warsaw","IN","US","Voluntary: Firm Initiated","Telephone","Nationwide distribution, including the states of MO, MI, WA, FL, NY, TN, CO, AZ, VA, TX, CA, MN, LA, NC, and UT.","Z-1941-2013","Class II","3.2mm Drill Bit. This is a component within the PediLoc Locking Plate System utilized to pre-drill a hole in bone prior to placement of a bone screw. ","LOT 91300335 - Catalogue Number 01-1050-0002",,"68","OrthoPediatrics has initiated a voluntary recall of Part # 01-1050-002, 2.5mm Drill Bit, Lot #91300335. Only drill bits that are in their original packaging are being recalled. The description on the package of this drill bit has a wrong size in the description (3.2mm). The recall affects only packaged devices still in original packaging due to misbranding of the product. The drill bit itself has the correct etched size, part number and lot number on it.",7/24/2013,"07/24/2013",8/21/2013,"08/21/2013"
"Devices",65829,"Ongoing","Arrow International Inc","Reading","PA","US","Voluntary: Firm Initiated","Letter","AL, PA, CT, NC, VA, KS, RI, AZ, NJ, and IL.","Z-1965-2013","Class II","Arrow International, Inc. Two-Lumen CVC Kit with Blue Flex Tip Catheter. The multiple lumen catheter permits venous access to the central circulation of patients."," Catalog # AK-17702-CDC, lot # RF2083258",,"156","Arrow is recalling the product due to a labeling inconsistency. One portion of the lidstock states the kit contains a 3-Lumen catheter while the rest of the lidstock correctly identifies the catheter as 2-Lumen. ",7/31/2013,"07/31/2013",8/21/2013,"08/21/2013"
"Devices",65831,"Ongoing","Medtronic Inc. Cardiac Rhythm Disease Management","Saint Paul","MN","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution - USA Nationwide CA, IL, LA, MI and the country of CANADA","Z-2105-2013","Class II","Medtronic Custom Perfusion System with Carmeda BioActive Surface. Model Numbers: CB1D82R12 and CB5N73R7. Sterilized by Ethylene Oxide, Do no Reuse. Product Usage: Usage: This product is indicated for use in the extracorporeal circuit during cardiopulmonary surgery. ","Lot: 12096267, 12105099, 12139669, 12166396, 12198322, 12309957, 12416020, 206119223, 206120062, 206180336, 206233199, 206384131, 206496179, 206649807, 206699258, 206758209, 206851971, 206864385, 206919887, 207003072, and 207071455. ",,"217","Medtronic was notified that Edwards Lifesciences has initiated a product recall for the Rigid Suction Wand, model S099B. The Wands are included within certain Perfusion Tubing Packs that are manufactured and distributed by Medtronic.",7/17/2013,"07/17/2013",9/4/2013,"09/04/2013"
"Devices",65831,"Ongoing","Medtronic Inc. Cardiac Rhythm Disease Management","Saint Paul","MN","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution - USA Nationwide CA, IL, LA, MI and the country of CANADA","Z-2104-2013","Class II","Medtronic Custom Perfusion System. Model Numbers: 1D80R8, 1E34R1, 1F75R1, 1G49R2, 1G75R1, 1P07R8, 1P91R4, 5B15R11, and 5P51R9. Sterilized by Ethylene Oxide, Do no Reuse. Product Usage: This product is indicated for use in the extracorporeal circuit during cardiopulmonary surgery. ","Lot: 11110924, 11178379, 11281864, 11341336, 11346822, 11357000, 11386060, 11387461, 11412023, 11448066, 11501190, 11506220, 11506223, 11528161, 11552139, 11577959, 11600953, 11623004, 11664710, 11672387, 11718344, 11719034, 11736936, 11816427, 11839402, 11843611, 11869817, 11896503, 11930457, 11995799, 11995883, 12000022, 12024743, 12024776, 12075385, 12093515, 12096289, 12166420, 12249817, 12264661, 12309956, 12374421, 12411720, 206168235, 206219230, 206325047, 206388493, 206476804, 206581948, 206597875, 206689812, 206709358, 206720707, 206851972, 206852054, 206864691, 206904419, 206991490, 207003054, 207100337, and 207121513.",,"13223","Medtronic was notified that Edwards Lifesciences has initiated a product recall for the Rigid Suction Wand, model S099B. The Wands are included within certain Perfusion Tubing Packs that are manufactured and distributed by Medtronic.",7/17/2013,"07/17/2013",9/4/2013,"09/04/2013"
"Devices",65831,"Ongoing","Medtronic Inc. Cardiac Rhythm Disease Management","Saint Paul","MN","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution - USA Nationwide CA, IL, LA, MI and the country of CANADA","Z-2106-2013","Class II","Medtronic Custom Perfusion System with Trillium BioSurface (a polymer containing non-leaching heparin). Model Numbers: TL4X17R8, TL5D01R, TL5D02R, TL5D02R3, TL5D02R5, and TL6A65R7. Sterilized by Ethylene Oxide, Do no Reuse. Product Usage: Usage: This product is indicated for use in the extracorporeal circuit during cardiopulmonary surgery. ","Lot: 11646955, 11669565, 11672312, 11713195, 11724203, 11749965, 11750036, 11787651, 11799982, 11822299, 11822308, 11878727, 11892549, 11908754, 11977672, 11982378, 11990416, 12019895, 12033691, 12075354, 12089790, 12096228, 12105079, 12111165, 12139696, 12155284, 12172596, 12178118, 12182890, 12191658, 12204951, 12204958, 12221793, 12227544, 12233759, 12236465, 12292171, 12323842, 12385431, 12399363, 12403798, 206110970, 206141990, 206142625, 206388507, 206476850, 206618547, 206649829, 206720637, 206758173, 206758215, 206851679, 206919848, 207003064, and 207030516.",,"758","Medtronic was notified that Edwards Lifesciences has initiated a product recall for the Rigid Suction Wand, model S099B. The Wands are included within certain Perfusion Tubing Packs that are manufactured and distributed by Medtronic.",7/17/2013,"07/17/2013",9/4/2013,"09/04/2013"
"Devices",65832,"Ongoing","Beckman Coulter Inc.","Brea","CA","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution - USA and the country of Canada.","Z-1997-2013","Class II","Hemoccult ICT (Immunochemical Fecal Occult Blood Test) is a rapid, visually read, qualitative immunochemical chromatographic method for detection of human hemoglobin in fecal samples.","Part Number 395067. All in-date lots (42 lots total). Lot Number: Manuf. Date: Exp. Date: M207143 27Jul2012 01/31/2014 M208454 21Sep2012 02/28/2014 M210079 19Oct2012 03/31/2014 M211100 30Nov2012 05/31/2014 M212122 20Dec2012 06/30/2014 M212203 17Jan2013 06/30/2014 M301418 22Feb2013 & 28Feb2013 07/31/2014 M202086 24Feb2012 07/31/2013 M203081 16Mar2012 07/31/2013 M203081A 23Mar2012 07/31/2013 M203262 06Apr2012 08/31/2013 M203098 13Apr2012 08/31/2013 M203098A 20Apr2012 08/31/2013 M203098B 25Apr2012 08/31/2013 M203080 27Apr2012 10/31/2013 M203080A 04May2012 10/31/2013 M203080B 11May2012 10/31/2013 M204276 18May2012 09/30/2013 M205199 12May2012 09/30/2013 M205288 22May2012 11/30/2013 M206021 06June2012 11/30/2013 M206166 18June2012 12/31/2013 M207072 05July2012 12/31/2013 M207143 27July2012 01/31/2014 M206259 26June2012 12/31/2013 M207332 30July2012 01/31/2014 M208345 22Aug2012 01/31/2014 M208272 24Aug2012 02/28/2014 M208454 06Sep2012 02/28/2014 M209135 19Sep2012 03/31/2014 M210079 04Oct2012 03/31/2014 M210169 27Oct2012 04/30/2014 M211100 10Nov2012 05/31/2014 M211078 01Dec2012 05/31/2014 M212122 12Dec2012 06/30/2014 M212203 03Jan2013 06/30/2014 M301324 16Jan2013 07/31/2014 M301418 11Feb2013 07/31/2014 M302410 27Feb2013 08/31/2014 M303157 15Mar2013 09/30/2014 M303223 26Mar2013 09/30/2014 M304130 09Apr2013 09/30/2014",".","68,116 units","Beckman Coulter has received a customer complaint that suggests trending of positive results has increased from approximately 4% to 1 0%. As a result of our investigation, Beckman Coulter has confinned an increase in sensitivity at the borderline positive level. '' This testing also demonstrated that the issue does not affect results reported as negative.",7/17/2013,"07/17/2013",8/28/2013,"08/28/2013"
"Devices",65833,"Ongoing","Zimmer, Inc.","Warsaw","IN","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution-USA (nationwide) including the states of CT, FL, GA, IL, IN, KS, KY, MA, MI, MN, MT, NC, NJ, NY, OH, OR, PA, SC, TN, TX, UT, VI, and WI, and the countries of Singapore, Canada, Mexico, Arab Emirates, Saudi Arabia, and Hong Kong.","Z-1981-2013","Class II","Moore Hip Prosthesis Long Fenestrated Stem, several head Diameter, 203 mm Stem length. Used to seat the prosthesis with or without bone cement.","25621400 203600 25711600 203800 25621300 25621500 203700 206500 26601000 60025547 25003900 60016485 60028037 60028040 60028041 60028042 60016492 60028045 60016487 60028036 60028038 60028039 60028043 60034329 60034330 60039203 60038245 60043146 60039161 60039170 60039173 25209700 60039184 60039186 60039201 60039207 60016491 60028044 60039214 60039217 60039218 60039220 60039222 60039223 60039224 60034328 60039158 60039199 60039216 223900 365036 365034 365037 60016497 60039221 60043147 60039166 60039168 60039182 60039183 60039209 60039219 60057784 60039213 60063014 60064868 60063150 60064885 60057785 60064862 60064867 60064886 60064888 60063042 60076067 60076073 60079812 60064887 60083643 60076089 60095965 60095967 60096024 60095966 60095988 60095986 60095978 60095989 60118708 365491 365488 365452 365495 365487 365455 365468 365460 365459 60096023 365469 365610 365470 365609 365476 365473 365483 365611 60187598 365608 60233503 366219 60278488 60293376 60301903 60301909 60301910 366367 366361 60293345 366362 366366 366371 366365 366359 366370 60335336 366368 60335394 366364 60331363 366369 366360 366440 60370153 366363 60323737 60441602 60459779 60501809 60506751 60553757 60532130 60609997 60610068 60506791 60717634 60717637 60717636 60750867 60750869 60823726 60834952 60845453 60933807 60940767 60979560 60990032 60659033 61199167 61496604 61501406 61582442 61582445 61582447 61582449 61582444 61599941 61496594 61658306 60750868 369883 61748928 61783682 61748929 61783684 61815823 61817989 61859934 61927043 61938355 61964729 62051548 62211964 62200345 62200346 62197219 62278696 62258850 62273053 62330362 62330364 62322473 62330365 ",".","1,710 units are in distribution","Zimmer recently conducted a review of historic packaging validations completed. Based on this review, it was determined that a subset of product packaged at a single Zimmer facility required testing to ensure that previously packaged product from this facility met the established requirements for sterile barrier integrity. This testing determined that a single packaging tray configuration, which consists of an inner and outer sterile tray, did not pass the established requirements for seal integrity and seal strength. Specifically, there was approximately 2% of either the inner or outer tray that did not pass the established requirements for seal integrity and seal strength. ",7/16/2013,"07/16/2013",8/28/2013,"08/28/2013"
"Devices",65834,"Ongoing","Blue Belt Technologies MN","Plymouth","MN","US","Voluntary: Firm Initiated","Telephone","Worldwide Distribution and US Nationwide in the states of: CA and PA. United Kingdom.","Z-1995-2013","Class II","Blue Belt Technologies, Inc. Monitor Drape REF: PFSD-V0001, Rx only, Sterile EO. Product Usage: The intended use of this device is t protect equipment from contamination during a variety of procedures throughout the clinical setting.","Lot: D130432, expires February 2018",".","60 cartons (20 pieces/carton) 40 in EU, 20 in US.","Blue Belt Technologies is recalling sterile Monitor Drapes used with their Navio PFS system during orthopedic knee surgery. The drapes are used to cover the Navio PFS system computer monitor and arm assembly and provide a sterile barrier in the surgical suite. The defect is evident when the computer monitor is being draped. The front section of the drape separates from the rest of the drape at the bond joint.",7/19/2013,"07/19/2013",8/28/2013,"08/28/2013"
"Biologics",65835,"Terminated","Community Blood Center of Carolinas","Charlotte","NC","US","Voluntary: Firm Initiated","Telephone","North Carolina","B-2439-13","Class II","Platelets Pheresis Leukocytes Reduced","W227013030339; ",".","1 Unit","Blood product, collected in a manner that may have compromised the sterility of the collection system, was distributed.",7/9/2013,"07/09/2013",10/30/2013,"10/30/2013"
"Biologics",65836,"Terminated","Innovative Blood Resources","Saint Paul","MN","US","Voluntary: Firm Initiated","Telephone","Wisconsin","B-2440-13","Class III","Red Blood Cells Leukocytes Reduced","W051513071676; W051513071671; ",".","2","Blood products, which may have reached an unacceptable temperature during storage, were distributed.",6/26/2013,"06/26/2013",10/30/2013,"10/30/2013"
"Devices",65837,"Ongoing","Medtronic Xomed, Inc.","Jacksonville","FL","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution - USA (nationwide) Nationwide, Hawaii, Puerto Rico and Guam. Internationally to: Canada, Austria, Belgium, Cyprus, France, Germany, Greece, India, Iran, Ireland, Israel, Italy, Kuwait, Lebanon, Luxembourg, Morocco, Netherlands, Nigeria, Portugal, Qatar, Reunion, Saudi Arabia, South Africa, Spain, Sweden, Switzerland, Turkey, United Arab Emirates, United Kingdom, Australia, New Zealand, Singapore, Thailand, Vietnam, China, Hong Kong,Taiwan, Korea, Japan, Brazil, Chile, Colombia, Costa Rica, Ecuador, Guatemala, Mexico, Nicaragua, and Venezuela.","Z-1934-2013","Class II","Tray Surgical, ENT (various instrument trays) Used for stot age and transportation of reusable surgical instruments utilized in various ear, nose and throat (ENT) and head and neck surgical procedures.","ALL Lots of the following models: Model 3717000 = 2 Level Instrument tray Model 3717001 = 3 Level tray (metal & radel) Model 3717006 = 2 Level Instruument tray with mat Model 3717026 = House Otology Set tray Model 3722301 = Wiet Chronic Ear Set tray Model 3747108 = Skykes Endobrow Lift tray Model 960374 = framelock tray Model *960-811 = Framelock Instrument set (includes tray 9603740 Model 960-619 = LandmarX tray Model *9731372XOM1 = Passive ENT Instrument Set (w/tray 960-619) Model MCOH0SC = Otology Plastic instrument tray Model MCO649SC = Middle Ear Instrument tray Model MCOS10SC = Instrument tray 2 level Model MCLS28 = MF Sataloff Complete Instrument tray Model MCLS37 = Sataloff Picks/Handles/Neddles Instrument tray Model 3319005 = Powerforma Bur Rack tray * instrument set that includes the identified tray",,"3,562 trays","The firm will recall and replace the identified instrument trays in the field, with trays that have improved labeling, including lids that contain the statement indicating 'PREVACUUM ONLY''",7/9/2013,"07/09/2013",8/21/2013,"08/21/2013"
"Devices",65838,"Ongoing","Edwards Lifesciences, LLC","Draper","UT","US","Voluntary: Firm Initiated","Letter","Nationwide and the country of Canada","Z-1963-2013","Class II","Edwards Lifesciences Anastaflo Intravascular Shunt, Model code IVS12512, IVS1512, IVS17512, IVS2012, IVS2512, IVS3012, IVS1530, IVS2030 and IVS25 Anastaflo shunts are intended for use in preventing ischemia by shunting and/ or perfusing blood or cardioplegic solution distal to the anastomosis site during the construction of coronary artery bypass grafts30.","Model: IVS12512 Lots 58969460 to 59509355, Model: IVS1512 Lots 58914820 to 59518788, Model: IVS1530 Lots 58911395 to 59473506, Model: IVS17512 Lots 58903206 to 59546227, Model: IVS2012 Lots 58911394 to 59531271, Model: IVS2030 Lots 58932183 to 59504235, Model: IVS2512 Lots 58914819 to 59518801, Model: IVS2530 Lots 58919317 to 59463362, Model: IVS3012 Lots 58966707 to 59514116",,"29,618 units","Edwards Lifesciences is recalling certain lots of the Anastaflo intravascular Shunt due to concerns of excessive adhesive on the shunt body that may interfere with suturing of by-pass grafts.",7/30/2013,"07/30/2013",8/21/2013,"08/21/2013"
"Devices",65839,"Ongoing","Philips Healthcare Inc.","Andover","MA","US","Voluntary: Firm Initiated","Letter","US Nationwide Distribution including Puerto Rico","Z-1964-2013","Class II","Philips Healthcare MobileDiagnostwDR system. Mobile Digital radiography X-Ray System Product Usage: MobileDiagnost wDR is a mobile digital radiography X-Ray System. It is intended for use by a qualified/trained doctor or technologist on both adult and pediatric patients for taking diagnostic radiographic exposures of the skull, spinal column, chest, abdomen, extremities, and other body parts. Applications can be performed with patient sitting, standing, or lying in the prone or supine positions. Not intended for mammography.","System Code - 712001",".","240 systems US -- 1 system within Puerto Rico","The Instructions for Use (IFU) for the MobileDiagnost wDR fails to comply with a Federal standard. The IFU does not provide tolerance levels for several generator values as required by 1020.30(h)(3).",6/11/2013,"06/11/2013",8/28/2013,"08/28/2013"
"Drugs",65840,"Ongoing","Novartis Consumer Health","Lincoln","NE","US","Voluntary: Firm Initiated","Letter","Nationwide, Canada, and Panama.","D-910-2013","Class III","Maalox Nighttime Antacid with Acid Reflux Barrier (calcium carbonate and alginic acid) chewable tablets, 500 mg/200 mg, Cherry flavor, 65-count tablets per bottle, Novartis Consumer Health Canada Inc., Mississauga, ON L5N 2X7, foreign labeling containing English and French, NPN 80000899, UPC 0 58478 10090 6.","Lot #: 10114318, Exp 01/14 ",".","11,760 bottles","Labeling: Incorrect or Missing Lot and/or Exp Date: The lot number and/or expiration date may be illegible on the outer plastic bottle packaging.",8/6/2013,"08/06/2013",8/28/2013,"08/28/2013"
"Drugs",65840,"Ongoing","Novartis Consumer Health","Lincoln","NE","US","Voluntary: Firm Initiated","Letter","Nationwide, Canada, and Panama.","D-906-2013","Class III","Maalox Extra Strength Antacid (calcium carbonate) chewable tablets,1000 mg, Wild Berry flavor, packaged in a) 35-count (UPC 0 58478 44829 9) and b) 65-count (UPC 0 58478 44842 8) tablets per bottle, Novartis Consumer Health Canada Inc., Mississauga, ON L5N 2X7, foreign labeling containing English and French, NPN 02238291.","Lot #: a) 10095535, Exp 07/13; 10101288, Exp 10/13; 10104665, Exp 01/14; 10111114, Exp 02/14; 10114314, Exp 04/14; 10120621, Exp 07/14; b) 10095536, Exp 07/13; 10101289, Exp 10/13; 10104666, Exp 01/14; 10111116, Exp 02/14; 10114315, Exp 04/14; 10120622, Exp 07/14 ",".","149,616 bottles","Labeling: Incorrect Or Missing Lot and/or Exp Date: The lot number and/or expiration date may be illegible on the outer plastic bottle packaging.",8/6/2013,"08/06/2013",8/28/2013,"08/28/2013"
"Drugs",65840,"Ongoing","Novartis Consumer Health","Lincoln","NE","US","Voluntary: Firm Initiated","Letter","Nationwide, Canada, and Panama.","D-902-2013","Class III","Maalox Extra Strength Antacid with Anti-Gas (calcium carbonate and simethicone) chewable tablets, 1000 mg/60 mg, Assorted Fruit flavor, 65-count tablets per bottle, Novartis Consumer Health Canada Inc., Mississauga, ON L5N 2X7, foreign labeling containing English and French, DIN 02243496, UPC 0 58478 44872 5.","Lot #: 10097345, Exp 08/13; 10104668, Exp 01/14; 10114317, Exp 03/14; 10120624, Exp 07/14 ",".","117,816 bottles","Labeling: Incorrect Or Missing Lot and/or Exp Date: The lot number and/or expiration date may be illegible on the outer plastic bottle packaging.",8/6/2013,"08/06/2013",8/28/2013,"08/28/2013"
"Drugs",65840,"Ongoing","Novartis Consumer Health","Lincoln","NE","US","Voluntary: Firm Initiated","Letter","Nationwide, Canada, and Panama.","D-903-2013","Class III","Maalox Regular Strength Antacid (calcium carbonate) chewable tablets, 600 mg, Wild Berry flavor, packaged in a) 50-count (UPC 0 58478 44825 1), b) 100-count (UPC 0 58478 44826 8) and c) 145-count (UPC 0 58478 44836 7) tablets per bottle, Novartis Consumer Health Canada Inc., Mississauga, ON L5N 2X7, foreign labeling containing English and French, NPN 02238290.","Lot #: a) 10095538, Exp 07/13; 10099449, Exp 09/13; 10104663, Exp 01/14; 10111110, Exp 02/14; 10114312, Exp 04/14; 10120619, Exp 07/14; b) 10095537, Exp 07/13; 10099451, Exp 09/13; 10104664, Exp 01/14; 10111112, Exp 02/14; 10114313, Exp 04/14; 10120620, Exp 07/14; c) 10095528, Exp 07/13; 10106998, Exp 01/14; 10120618, Exp 07/14 ",".","112,728 bottles","Labeling: Incorrect Or Missing Lot and/or Exp Date: The lot number and/or expiration date may be illegible on the outer plastic bottle packaging.",8/6/2013,"08/06/2013",8/28/2013,"08/28/2013"
"Drugs",65840,"Ongoing","Novartis Consumer Health","Lincoln","NE","US","Voluntary: Firm Initiated","Letter","Nationwide, Canada, and Panama.","D-905-2013","Class III","Maalox Advanced Maximum Strength Antacid & Antigas (calcium carbonate and simethicone) chewable tablets, 1000 mg/60 mg, Assorted Fruit flavor, packaged in a) 35-count (NDC 0067-6279-35) (UPC 3 0067-0343-35 4); b) 65-count (NDC 0067-6279-65) (UPC 3 0067-0343-65 1); and c) 90-count (NDC 0067-6279-90) (UPC 3 0067-0343-90 3) tablets per bottle, Distributed by: Novartis Consumer Health, Inc., Parsippany, NJ 07054-0622.","Lot #: a) 10090971, Exp 08/13; 10101253, Exp 09/13; 10102751, Exp 11/13; 10104624, Exp 01/14; 10108954, 10108955, Exp 02/14; 10111942, 10111943, Exp 03/14, 10117575, Exp 04/14; b) 10095525, Exp 07/13; 10097329, Exp 08/13; 10099437, 10101254, Exp 09/13; 10101255, 10102752, Exp 10/13; 10104625, 10104626, Exp 11/13; 10104627, 10109871, 10110711, 10109182, Exp 01/14; 10109872, 10110003, Exp 02/14; 10111941, Exp 03/14; 10115413, 10116855, Exp 04/14; 10118565, 10118566, Exp 06/14; 10120611, 10120612, Exp 07/14; 10123086, Exp 08/14; c) 10093109, 10093111, 10093112, Exp 06/13; 10095529, 10095540, Exp 07/13; 10097330, 10097331, Exp 08/13; 10099438, 10099439, 10099440, Exp 09/13; 10101256, 10101257, Exp 10/13; 10102753, 10102754, 10104628, Exp 11/13; 10104629, Exp 12/13; 10104630, 10104631, 10108289, 10108290, Exp 01/14; 10107564, 10109868, 10110004, 10110005, Exp 02/14; 10111938, 10111939, 10113621, 10113622, 10114320, 10114321, Exp 03/14; 10114322, 10114323, 10116852, Exp 04/14; 10116853, Exp 05/14; 10118563, 10118564, Exp 06/14; 10120613, 10120614, Exp 07/14; 10123087, 10123088, 10123089, Exp 08/14; 10126000, 10126001, 10126002, Exp 09/14; 10128831, 10128833, Exp 10/14",".","3,451,224 bottles","Labeling: Incorrect Or Missing Lot and/or Exp Date: The lot number and/or expiration date may be illegible on the outer plastic bottle packaging.",8/6/2013,"08/06/2013",8/28/2013,"08/28/2013"
"Drugs",65840,"Ongoing","Novartis Consumer Health","Lincoln","NE","US","Voluntary: Firm Initiated","Letter","Nationwide, Canada, and Panama.","D-904-2013","Class III","Maalox Advanced Maximum Strength Antacid & Antigas (calcium carbonate and simethicone) chewable tablets, 1000 mg/60 mg, Wild Berry flavor, 65-count tablets per bottle, Distributed by: Novartis Consumer Health, Inc., Parsippany, NJ 07054-0622, NDC 0067-62791-65, UPC 3 0067-0376-65 9.","Lot #: 10093113, Exp 06/13; 10097332, Exp 08/13; 10101258, Exp 10/13; 10104632, Exp 12/13; 10108852, Exp 01/14; 10104633, 10110688, Exp 02/14; 10111944, Exp 03/14; 10114325, Exp 05/14; 10120609, 10120610, Exp 07/14; 10123084, Exp 09/14",".","410,220 bottles","Labeling: Incorrect Or Missing Lot and/or Exp Date: The lot number and/or expiration date may be illegible on the outer plastic bottle packaging.",8/6/2013,"08/06/2013",8/28/2013,"08/28/2013"
"Drugs",65840,"Ongoing","Novartis Consumer Health","Lincoln","NE","US","Voluntary: Firm Initiated","Letter","Nationwide, Canada, and Panama.","D-908-2013","Class III","Maalox Extra Strength Antacid with Anti-Gas (calcium carbonate and simethicone) chewable tablets, 600 mg/60 mg, Wild Berry flavor, 35-count tablets per bottle, Novartis Consumer Health Canada Inc., Mississauga, ON L5N 2X7, foreign labeling containing English and French, DIN 02243496, UPC 0 58478 44840 4.","Lot #: 10093133, Exp 06/13; 10099452, Exp 09/13; 10104667, Exp 12/13; 10110926, Exp 02/14; 10114316, Exp 04/14; 10120623, Exp 07/14; 10123098, Exp 09/14 ",".","129,048 bottles","Labeling: Incorrect Or Missing Lot and/or Exp Date: The lot number and/or expiration date may be illegible on the outer plastic bottle packaging.",8/6/2013,"08/06/2013",8/28/2013,"08/28/2013"
"Drugs",65840,"Ongoing","Novartis Consumer Health","Lincoln","NE","US","Voluntary: Firm Initiated","Letter","Nationwide, Canada, and Panama.","D-907-2013","Class III","Maalox, Regular Strength Antacid (calcium carbonate) chewable tablets, 600 mg, Wintergreen flavor, 50-count tablets per bottle, Novartis Consumer Health Canada Inc., Mississauga, ON L5N 2X7, foreign labeling containing English and French, NPN 02238290, UPC 0 58478 44824 4.","Lot #: 10095534, Exp 07/13; 10114311, Exp 04/14",".","46,680 bottles","Labeling: Incorrect Or Missing Lot and/or Exp Date: The lot number and/or expiration date may be illegible on the outer plastic bottle packaging.",8/6/2013,"08/06/2013",8/28/2013,"08/28/2013"
"Drugs",65840,"Ongoing","Novartis Consumer Health","Lincoln","NE","US","Voluntary: Firm Initiated","Letter","Nationwide, Canada, and Panama.","D-909-2013","Class III","Maalox Nighttime Antacid with Acid Reflux Barrier (calcium carbonate and alginic acid) chewable tablets, 500 mg/200 mg, Mint flavor, 65-count tablets per bottle, Novartis Consumer Health Canada Inc., Mississauga, ON L5N 2X7, foreign labeling containing English and French, NPN 80000899, UPC 0 58478 10091 3.","Lot #: 10107000, Exp 07/13; 10114319, Exp 01/14 ",".","23,856 bottles","Labeling: Incorrect Or Missing Lot and/or Exp Date: The lot number and/or expiration date may be illegible on the outer plastic bottle packaging.",8/6/2013,"08/06/2013",8/28/2013,"08/28/2013"
"Devices",65841,"Ongoing","Sarken, Inc.","Tempe","AZ","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution - US Nationwide in the country Virgin Islands","Z-2048-2013","Class II","SARKEN STAT! Multi-Drug Test Panel Product Usage- Labeled as FOR FORENSIC USE ONLY (Employee, Student or Probation Testing). ","Manufacturer's Product Number HMO-W264 Lot Number F2290966 Expiration Date: 02/2014",,"various quantities","These products are being recalled because they were distributed without adequate labeling and instructions for use. Inadequate labeling could lead to misuse of the Test Kits and incorrect test results.",7/29/2013,"07/29/2013",9/4/2013,"09/04/2013"
"Devices",65841,"Ongoing","Sarken, Inc.","Tempe","AZ","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution - US Nationwide in the country Virgin Islands","Z-2050-2013","Class II","SARKEN STAT! 1- Panel Test Kit-THC Product Usage- Labeled as FOR FORENSIC USE ONLY (Employee, Student or Probation Testing). ","Manufacturer's Product Number DTH-114 Lot Number THC1120052 THC2120005 THC211100044 THC2100044 THC2120006 Expiration Date: 12/2013 10/2014 09/2014 09/2014 11/2014 ",,"various quantities","These products are being recalled because they were distributed without adequate labeling and instructions for use. Inadequate labeling could lead to misuse of the Test Kits and incorrect test results.",7/29/2013,"07/29/2013",9/4/2013,"09/04/2013"
"Devices",65841,"Ongoing","Sarken, Inc.","Tempe","AZ","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution - US Nationwide in the country Virgin Islands","Z-2052-2013","Class II","SARKEN STAT! 1- Panel Test Kit-mAMP Product Usage: Labeled as FOR FORENSIC USE ONLY (Employee, Student or Probation Testing). ","Manufacturer's Product Number DMA-114 Lot Number MET2100027 Expiration Date: 08/2014",,"various quantities","These products are being recalled because they were distributed without adequate labeling and instructions for use. Inadequate labeling could lead to misuse of the Test Kits and incorrect test results.",7/29/2013,"07/29/2013",9/4/2013,"09/04/2013"
"Devices",65841,"Ongoing","Sarken, Inc.","Tempe","AZ","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution - US Nationwide in the country Virgin Islands","Z-2049-2013","Class II","SARKEN STAT! Multi-Drug Test Panel Product Usage- Labeled as FOR FORENSIC USE ONLY (Employee, Student or Probation Testing). ","Manufacturer's Product Number DOA-254 Lot Number DOA2050035 DOA2090666 DOA2110059 DOA2120771 Expiration Date: 02/2014 07/2014 08/2014 10/2014 ",,"various quantities","These products are being recalled because they were distributed without adequate labeling and instructions for use. Inadequate labeling could lead to misuse of the Test Kits and incorrect test results.",7/29/2013,"07/29/2013",9/4/2013,"09/04/2013"
"Devices",65841,"Ongoing","Sarken, Inc.","Tempe","AZ","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution - US Nationwide in the country Virgin Islands","Z-2053-2013","Class II","SARKEN STAT! 1- Panel Test Kit-OPI Product Usage: Labeled as FOR FORENSIC USE ONLY (Employee, Student or Probation Testing).","Manufacturer's Product Number DOP-114 Lot Number OPI2100003 Expiration Date: 09/2014",,"various quantities","These products are being recalled because they were distributed without adequate labeling and instructions for use. Inadequate labeling could lead to misuse of the Test Kits and incorrect test results.",7/29/2013,"07/29/2013",9/4/2013,"09/04/2013"
"Devices",65841,"Ongoing","Sarken, Inc.","Tempe","AZ","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution - US Nationwide in the country Virgin Islands","Z-2051-2013","Class II","SARKEN STAT! 1- Panel Test Kit-COC Product Usage- Labeled as FOR FORENSIC USE ONLY (Employee, Student or Probation Testing). ","Manufacturer's Product Number DCO-114 Lot Number COC2010004 COC2110076 Expiration Date: 12/2013 09/2014 ",,"various quantities","These products are being recalled because they were distributed without adequate labeling and instructions for use. Inadequate labeling could lead to misuse of the Test Kits and incorrect test results.",7/29/2013,"07/29/2013",9/4/2013,"09/04/2013"
"Drugs",65842,"Ongoing","Healthy Life Chemistry Inc dba Purity First","Deer Park","NY","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Approximately 30% of all finished products were sold to customers in interstate to include but may not be limited to NY, NJ & CT via UPS. Products are promoted and sold directly to customers at Healthy Life Chemistry's retail store at 13A Lucon Drive in Deer Park, NY, on the company website (www.purityfirst.com), and are available at the health food store, Total Health, located at 120 Rte 110, Farmingdale, NY (www.totaldiscountvitamins.com).","D-374-2014","Class I","Multi-Mineral capsules, 200-count bottles, labeled in part as Healthy Life Chemistry, By Purity First, Manufactured for: Purity First Health Products, Inc. Healthy Life Chemistry 51 Florida Street, Farmingdale, NY 11735; 1-800-696-7017","lot number: 12-829",".","unknown","Marketed Without An Approved NDA/ANDA: New York State Department of Health analysis of this product found it to contain undeclared steroid-like substances making it an unapproved new drug.",7/31/2013,"07/31/2013",12/26/2013,"12/26/2013"
"Drugs",65842,"Ongoing","Healthy Life Chemistry Inc dba Purity First","Deer Park","NY","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Approximately 30% of all finished products were sold to customers in interstate to include but may not be limited to NY, NJ & CT via UPS. Products are promoted and sold directly to customers at Healthy Life Chemistry's retail store at 13A Lucon Drive in Deer Park, NY, on the company website (www.purityfirst.com), and are available at the health food store, Total Health, located at 120 Rte 110, Farmingdale, NY (www.totaldiscountvitamins.com).","D-373-2014","Class I","B-50 capsules, 100-count bottles, labeled in part as Healthy Life Chemistry, By Purity First, Manufactured for: Purity First Health Products, Inc. Healthy Life Chemistry 51 Florida Street, Farmingdale, NY 11735; 1-800-696-7017","lot numbers: F03Q, C02R",".","unknown","Marketed Without An Approved NDA/ANDA: FDA analysis of this product found it to contain undeclared steroids and steroid-like substances making this an unapproved new drug.",7/31/2013,"07/31/2013",12/26/2013,"12/26/2013"
"Devices",65843,"Ongoing","Radiometer America Inc","Westlake","OH","US","Voluntary: Firm Initiated","Letter","Worldwide distribution: US (nationwide) AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, TX, UT, VA, VT, WA, WI, WV & WY; and country of: Canada.","Z-1930-2013","Class II","TCM4 series Base Units, and spare part Power Supply, Radiometer Medical ApS, Akandevej 21, Brnshj, Denmark, www.radiometer.com. The devices are intended for continuous monitoring of carbon dioxide and oxygen partial pressures, oxygen saturation, and pulse rate. ","TCM4 series Base Units: 000-154, 391-876, 391-878 and 391-880 below R0175N009 & Power Supply (Spare part): 910-246. Serial #: 154R0002N002, 154R0004N003, 154R0004N008, 154R0005N004, 154R0005N005, 154R0005N005-U, 154R0005N006-154R0005N006, 154R0006N005, 154R0006N006, 154R0006N008-154R0006N010, 154R0007N001-154R0007N010, 154R0008N001, 154R0008N002, 154R0008N002U, 154R0008N003, 154R0008N005-154R0008N010, 154R0009N004, 154R0009N010, 154R0011N003, 154R0011N006-154R0011N009, 154R0012N001-154R0012N003, 154R0013N004, 154R0013N005, 154R0013N007-154R0013N010, 154R0014N009, 154R0016N001-154R0016N003, 154R0016N008, 154R0016N009, 154R0016N010, 154R0017N007, 154R0019N001-154R0019N005, 154R0019N007, 154R0019N009, 154R0019N010, 154R0020N002, 154R0021N003, 154R0021N004U, 154R0021N005, 154R0021N008, 154R0021N010, 154R0022N008-154R0022N010, 154R0023N006, 154R0023N007, 154R0023N009, 154R0023N010, 154R0024N004-154R0024N006, 154R0024N009, 154R0024N010, 154R0025N002, 154R0025N004-154R0025N006, 154R0026N008, 154R0027N001-154R0027N005, 154R0027N007, 154R0028N001-154R0028N004, 154R0028N006-154R0028N006, 154R0029N003-154R0029N007, 154R0029N009, 154R0030N001, 154R0030N004-, 54R0030N007, 154R0030N008U, 154R0031N001, 154R0031N003-154R0031N009, 154R0034N006, 154R0034N008, 154R0034N009, 154R0035N002, 154R0035N003, 154R0035N006, 154R0035N008, 154R0035N009, 154R0035N010, 154R0036N010, 154R0036N002-154R0036N009, 154R0038N002-154R0038N006, 154R0040N001, 154R0040N002, 154R0040N009, 154R0040N010, 154R0041N001, 154R0041N003, 154R0041N004, 154R0041N006-154R0041N008, 154R0042N001, 154R0042N002, 154R0042N004, 154R0042N005, 154R0046N002, 154R0046N004, 154R0046N006-154R0046N008, 154R0047N002, 154R0048N002-154R0048N004, 154R0048N007, 154R0050N001-154R0050N009, 154R0051N001, 154R0051N003-154R0051N003, 154R0052N001-154R0052N009, 154R0053N007-154R0053N010, 154R0054N001, 154R0054N002, 154R0054N004, 154R0055N002-154R0055N006, 154R0056N001, 154R0056N002, 154R0056N005, 154R0056N006, 154R0056N008-154R0056N010, 154R0057N001-154R0057N004, 154R0057N008, 154R0057N00",".","5,874 units","RADIOMETER became aware that the TCM4 series Base Unit does not comply with IEC 60601-1 Sub Clause 15B.",11/27/2012,"11/27/2012",8/14/2013,"08/14/2013"
"Drugs",65844,"Ongoing","West-Ward Pharmaceutical Corp.","Eatontown","NJ","US","Voluntary: Firm Initiated","Letter","Nationwide","D-883-2013","Class II","Belladonna Alkaloids with Phenobarbital Tablets, 1000 count (NDC 0143-1140-10) and 5000 count (NDC 0143-1140-51) PET bottles, Rx Only, Manufactured by West-ward Pharmaceutical Corp., Eatontown, N.J., 07724.","1000's: Catalog #1140-10; Lot #/Expiry Dates: 67328A; 67329A; 67330B; 67330C/Dec 2013; 68064B; 68065A/Jan 2014; 68666B; 68667A/May 2015; 69721A/Dec 2015 and 69722A/Jan 2016. 5000's: Catalog #1140-51; Lot #/Expiry Dates: 68064A/Jan 2015 and 68666A/May 2015.",,"1000 count bottles/61,370 and 5000 count bottles/321","Presence of Foreign Substance: black specks comprised of degraded organic material found on tablets",7/30/2013,"07/30/2013",8/21/2013,"08/21/2013"
"Food",65845,"Ongoing","SensoryEffects Powder Systems","Defiance","OH","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Product was shipped to the following states: KY, MN, SD, WA. Product was also shipped to Canada.","F-1848-2013","Class II","Maple flavored lipid-based inclusions. Maple NT-RF and Maple NT-MF, NET WT: 50 lbs, Ingredients: Sugar, vegetable oil (palm, palm kernel), wheat flour, cocoa powder, glucose, extractives of foenugreek, maple sugar, caramel color, soy lecithin. SensoryEffects , 136 Fox Run Dr., Defiance, OH 43512","Item code 20526 Maple NT-RF lot 2013-36707 and Item code 20525 Maple NT-MF lot 2013-36708",".","Lot 2013-36707 120/50 lb boxes. Lot 2013-36708 247/50 lb boxes","The firm was notified by a customer that a random sample from lot 2013-36707 tested positive for Salmonella.",7/20/2013,"07/20/2013",8/28/2013,"08/28/2013"
"Biologics",65846,"Terminated","Mississippi Blood Services Inc.","Flowood","MS","US","Voluntary: Firm Initiated","FAX","Mississippi; Switzerland","B-2441-13","Class II","Red Blood Cells Leukocytes Reduced","W069111133260; ",".","1","Blood products, collected from a donor whose suitability to donate was not adequately determined, were distributed. ",6/27/2013,"06/27/2013",10/30/2013,"10/30/2013"
"Biologics",65846,"Terminated","Mississippi Blood Services Inc.","Flowood","MS","US","Voluntary: Firm Initiated","FAX","Mississippi; Switzerland","B-2442-13","Class III","Blood and Blood Products for Reprocessing","W069111133260; ",".","1","Blood products, collected from a donor whose suitability to donate was not adequately determined, were distributed. ",6/27/2013,"06/27/2013",10/30/2013,"10/30/2013"
"Veterinary",65847,"Ongoing","Steve's Real Foods","Ogden","UT","US","Voluntary: Firm Initiated","Letter","Nationwide.","V-011-2014","Class I","DOG FOOD MAKING A DIFFERENCE, RAW FROZEN DOG FOOD, STEVE'S REAL FOOD, CHICKEN CANINE RECIPE, Net Wt. 5lbs. (2.3 kg), 8oz Patties, ''Use By''date of 11-7-13, UPC 6-91730-14202-5, Fortified with Raw Goat's Milk, Vegetarian Fed, Free Range, No Added Artibiotics or Hormones, Produce Grown without Pesticides, POUR AND SERVE NUGGETS, NATURALLY DELICIOUS RAW DOG FOOD, Feeding Guidelines, SAFE HANDLING Follow the same health standards and food handling techniques you would for your human family's raw meats and other foods. Keep Frozen.","LOT A220, MRF#: 81, UPC - 6-91730-14202-5",".","42 cases - 168 Bags","Steve's Real Food is recalling its ''Chicken Canine Recipe'' due to potential contamination with Salmonelle.",7/26/2013,"07/26/2013",12/11/2013,"12/11/2013"
"Devices",65848,"Ongoing","Siemens Medical Solutions USA, Inc","Martinez","CA","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution - USA Nationwide in the states of NJ, IN, PA, FL, OH, MN, MO, CA, AL, NE MI, LA. and countries of:Argentina, China, South Africa, Pakistan, Spain, Switzerland, Italy, Algeria, Croatia, Turkey, Canada, Germany, France, Poland, Japan, Russian Federation. Lebanon, Egypt, Slovakia, Latvia, Kenya, Brazil, Kuwait, Saudi Arabia, Greece, Belgium, Taiwan, Portugal.","Z-2095-2013","Class II","PRIMUS, ONCOR, ARTISTE Linac systems with component Tabletop, 550TxT, TT-A s/n 1001-1233 and Tabletop 550TxT, TT-S s/n 1001-1083. Product Usage: The intended use of the SIEMENS branded, ARTISTE, ONCOR and PRIMUS family of linear accelerator systems is to deliver X-ray photon and electron radiation for the therapeutic treatment of cancer.","ONCOR, PRIMUS and ARTISTE Lican systems with tabletop component: Tabletop, 550TxT, TT-A 08632296* Tabletop, 550TxT, TT-S 10046140 ",,"179 active devices.","Siemens has become aware of a customer complaint concerning the rail threaded holes of the 550TxT treatment tabletop. Due to a manufacturing error, the screws holding the side rails in position on the tabletop might break off. ",7/18/2013,"07/18/2013",9/4/2013,"09/04/2013"
"Devices",65850,"Ongoing","Zimmer, Inc.","Warsaw","IN","US","Voluntary: Firm Initiated","Letter","Internationally Distributed in China only.","Z-2101-2013","Class II","ZIMMER PERIARTICULAR LOCKING PLATE SYSTEM DISTAL MEDIAL HUMERAL LOCKING PLATE, SHORT RIGHT 11 HOLES 178 MM LENGTH STERILE RX ONLY Product Usage: Usage: The Periarticular Locking Plate System is indicated for temporary internal fixation and stabilization of osteotomies and fractures, including: Comminuted fractures, supracondylar fractures, intra-articular and extra-articular condylar fractures, fractures in osteopenic bone, nonunions, and malunions. ","Item No. 47-2358-107-11; Lots 61803307, 61969598, and 62084127 Item No. 47-2358-107-15; Lot 61825319 ",,"11 units","Zimmer is initiating a lot specific voluntary recall of the Distal Medial Humeral Locking Plate, Short due to the incorrect information printed on the Chinese label. The original label indicates that implants are RIGHT sided, but the Chinese label indicates that the implants are LEFT sided. ",7/30/2013,"07/30/2013",9/4/2013,"09/04/2013"
"Drugs",65851,"Ongoing","AbbVie Inc.","North Chicago","IL","US","Voluntary: Firm Initiated","Letter","Nationwide","D-901-2013","Class III","Mavik trandolapril tablets 4mg, 100 count bottle, Rx only, Manufactured by Halo Pharmaceutical Inc., Whippany, NJ for Abbott Laboratories, North Chicago, IL 60064, USA","Lot 22033GY",".","704 bottles","Labeling: Incorrect Package Insert; product packaged with outdated version of the insert",8/1/2013,"08/01/2013",8/28/2013,"08/28/2013"
"Devices",65852,"Ongoing","Siemens Healthcare Diagnostics","Tarrytown","NY","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution - USA (nationwide) and the countries of Austria, Australia, Belgium, Bosnia - Herzegovina, China, Croatia, Czech Republic, Denmark, Egypt, Finland, France, Germany, Greece, Hungary, Iceland, India, Indonesia, Ireland, Iraq, Israel, Italy, Japan, Kenya, Republic of Korea, Kuwait, Lebanon, Lithuania, Luxembourg, Martinique, Malaysia, Netherlands, Norway, New Zealand, Philippines, Poland, Portugal, Romania, Russian Republic, Saudi Arabia, Serbia, Singapore, Slovakia, Slovenia, South Africa, Spain, Sweden, Switzerland, Thailand, Turkey, Ukraine, United Arab Emirates, United Kingdom and Vietnam.","Z-2114-2013","Class II","ADVIA 120 Hematology Analyzer, Catalog Numbers SMN 10360958 and 10360959 . The ADVIA 120 is a hematology system that utilizes the principles of flow cytometry in order to provide complete blood counts.","All serial numbers",,"Domestic: 950 units; Foreign: 3369 units","The ADVIA 120 optics cover or hood is located on the very top of the ADVIA 120 analyzer. When the optics cover is raised, it is supported by two gas struts (SMN 10309266) attached to the cover on the left and right sides. Over time, it is possible that these struts may lose their effectiveness and fail to support the optics cover in the open position. This could cause the cover to fall during maintenance procedures.",6/26/2013,"06/26/2013",9/4/2013,"09/04/2013"
"Drugs",65853,"Ongoing","Nexus Pharmaceuticals Inc","Vernon Hills","IL","US","Voluntary: Firm Initiated","Letter","Nationwide","D-925-2013","Class II","Benztropine Mesylate Injection, USP, 2 mg/mL(1 mg/1 mL), 2 mL Single Dose Vial, Rx only, Manufactured in the USA for Nexus Pharmaceuticals Inc, Lincolnshire, IL 60069, NDC 14789-300-02"," a) Lot: 112911, Exp. 11/13, b) Lot: 030712, Exp. 3/14",,"46,185 vials","Presence of particulate matter: characterized as thin colorless flakes that are visually and chemically consistent with glass delamination.",8/1/2013,"08/01/2013",9/4/2013,"09/04/2013"
"Devices",65854,"Ongoing","HemoCue AB","Angelholm",,"SE","Voluntary: Firm Initiated","Letter","Worldwide Distribution - USA (nationwide) and internationally to AUSTRALIA, BELGIUM, CANADA, COTE D'IVOIRE, DENMARK, EGYPT, FINLAND, FRANCE, GEORGIA, GERMANY, GREECE, IRELAND, ITALY, KENYA, NETHERLANDS, NEW ZEALAND, NORWAY, OMAN, POLAND, QATAR, RUSSIAN FEDERATION, SPAIN, SWEDEN, SWITZERLAND, UNITED KINGDOM, VIET NAM & YEMEN. .","Z-2190-2013","Class II","HemoCue Glucose 201 Microcuvettes, 25 Microcuvettes Individually Packaged. The HemoCue Glucose 201 Microcuvettes are designed for use with the HemoCue Glucose 201 Analyzer and the HemoCue Glucose 201 DM Analyzer. Quantitative determination of glucose in whole blood using a specially designed analyzer, the HemoCue Glucose 201 with Plasma conversion. The quantitative determination of the instant blood glucose concentration in circulation supplements the clinical evidence in the diagnosis and treatment of patients with diabetes as well as monitoring of neonatal blood glucose levels.","Model #, 110705, Lot #, 1207767, 1208500; 1208501; 1208772; 1208773; 1208775; 1208777-1208781; 1208787; 1208788; 1208794; 1208795; 1209513-1209517; 1209527-1209531; 1209539; 1209540; 1209546; 1209547; 1210550; 1210551; 1210556-1210558; 1210560; 1210570-1210574; 1210581-1210583; 1210587; 1210590; 1210591; 1211599; 1211602-1211605; 1211608; 1211611; 1211614; 1211616; 1211618; 1211621; 1211623; 1211626; 1211627; 1211635; 1211636; 1211646-1212649; 1212654; 1212655; 1212659; 1212676-1212680; 1212687-1212689; 1212691-1212695; 1301702-1301705; 1301712; 1301713; 1301723-1301725; 1301733-1301735; 1302761-1302763; 1302768; 1302776; 1302777; 1303504-1303508; 1303517; 1303518; 1303522-1303524; 1303785-1303787; 1303794; 1303796; 1303797 & 1304534-1304537. Model #, 110717, Lot #, 1208503; 1208785; 1208786; 1208789; 1208790; 1208796; 1208797; 1208798; 1209504 - 1209510; 1209518-1209521; 209526; 1209533; 1209534; 1209537; 1209541; 1210552; 1210553; 1210559; 1210561; 1210569; 1210575-1210579; 1210584-1210586; 1210589; 1210600; 1211598; 1211601; 1211606; 1211609; 1211610; 1211617; 1211619; 1211620; 1211628-1211630; 1211639-1211642; 1212650-1212652; 1212671-1212673; 1212681-1212685; 1212696; 1212698; 1212699; 1301709-1301711; 1301716-1301719; 1301722; 1301726-1301729; 1301732; 1302754-1302756; 1302766; 1302767; 1302771-1302773; 1302778-1302781; 1303500-1303502; 1303509-1303513; 1303519-1303521; 1303782; 1303788-1303792; 1303798; 1303799; 1304526- 1304531 & 1304542-1304544. Model #, 110718, Lot #, 1208502; 1208782-1208784; 1208792; 1208793; 1208799; 1209511; 1209512; 1209522; 1209523; 1209532; 1209535; 1209536; 1209538; 1209542; 1209544; 1209545; 1210554; 1210555; 1210562-1210568; 1210580; 1210592-1210596; 1211607; 1211612; 1211622; 1211631-1211633; 1211643-1211645; 1212653; 1212674; 1212675; 1212686; 1212700; 1212701; 1301706; 1301708; 1301714; 1301715; 1301720; 1301721; 1301730; 1301731; 1302759; 1302760; 1302764; 1302765; 1302774; 1303503; 1303514-1303516; 1303525; 1303783; 1303784; 1303793; 1304532; 1304533 & 1304539-13",".","22,215 boxes of 100 cuvettes distributed in US, 34, 841 distributed outside the US ","During a complaint investigation HemoCue AB discovered punctured HemoCue Glucose 201 single pack pouches. ",7/15/2013,"07/15/2013",9/18/2013,"09/18/2013"
"Devices",65855,"Ongoing","Endogastric Solutions Inc","Redmond","WA","US","Voluntary: Firm Initiated","Letter","Distributed nationwide and Italy.","Z-1982-2013","Class II","EndoGastric Solutions EsophyX2 Device with Serosa Fastener and Accessories. Models R2001 and R2002. Indicated for the treatment of symptomatic chronic gastroesophageal reflux disease. ","UN-EXPIRED devices with Expiration dates (8/31/2013, 11/30/2013, 12/31/2013, and 1/31/2014) and following LOT numbers: 401132, 401147, 401152, 401156, 401159, 401167, 401207, 401214, 401219, 401220, 401225, 401227, 401230, 401233, 401236, 401246, 401248, 401251, 401257, 401258, 401259, 401267, 401269, 401271, 401274, and 401276. EXPIRED devices with Expired dates (1/31/2013, 2/28/2013, 3/31/2013 4/30/2013, 5/31/2013, 6/30/2013, and 7/31/2013) and following LOT numbers: 400923, 400927, 400934, 400937, 400940, 400943, 400949, 400961, 400963, 400973, 400976, 400979, 400980, 400981, 400984, 400986, 400992, 400994, 400997, 400998, 401004, 401005, 401009, 401012, 401016, 401017, 401024, 401026, 401029, 401056, 401058, 401059, 401060, 401061, 401062, 401063, 401065, 401072, 401074, 401076, 401079, 401084, 401085, 401092, 401094, 401107, 401114, 401115, 401121, 401129, and 401130. ",".","5192 units in the US and 41 units outside the US","Endogastric Solutions, Inc. has received a limited number of reports relating to the loss of tissue mold control when operating the R2001 or R2002 EsophyX2 device. In one case, surgical intervention was necessary to remove the device.",6/6/2013,"06/06/2013",8/28/2013,"08/28/2013"
"Drugs",65856,"Ongoing","GlaxoSmithKline, LLC.","Zebulon","NC","US","Voluntary: Firm Initiated","Letter","U.S. Nationwide","D-850-2013","Class III","TUMS, Antacid/Calcium Supplement, ULTRA Strength 1000, Assorted Berries, 72 Chewable Tablets, GlaxoSmithKline, Moon Twp, PA 15108, NDC 0135-0181-02","Lot 3C11 and 3C11A",".","300,480 bottles","Presence of Foreign Tablets/Capsules: Product labeled TUMS Ultra Assorted Berries 1000mg Chewable tables, may contain EX TUMS Assorted Berries 750mg tablets",7/18/2013,"07/18/2013",8/14/2013,"08/14/2013"
"Devices",65857,"Ongoing","Vital Signs Devices, a GE Healthcare Company","Totowa","NJ","US","Voluntary: Firm Initiated","Letter","Worldwide distribution: US (nationwide) and countries of: Australia, Belgium, Canada, Czech Republic, Finland, France, Germany, Italy, Lebanon, Netherlands, Norway, Poland, Saudi Arabi, Singapore, South Africa, Spain, Sweden and United Kingdom.","Z-1959-2013","Class II","Disposable Temperature Probes, (sterile), Sensor diameter: 3mm/0.12 in; 25 units per box. Vital Signs Inc. a GE Healthcare Company, 20 Campus Road, Totowa, NJ 07512 USA, www.gehealthcare.com/vitalsigns. Continuous temperature monitoring.","GE product number M1024229",,"12,239 units (5,002 units US, 7,237 units OUS).","GE Healthcare has become aware of a potential safety issue associated with the use of GE General Purpose 9 French Temperature Probe, Disposable, 400 Series [M1024229]. GEs Disposable General Purpose 9FR Temperature Probe M1024229 is intended for oro-esophageal and rectal use. As it pertains to esophageal placement, it has been brought to our attention that some users are inserting the probe nasally which may result in epistaxis (nosebleed). Epistaxis can vary in severity and include severe bleeding that may require specialty (otolaryngology) care.",7/18/2013,"07/18/2013",8/21/2013,"08/21/2013"
"Biologics",65858,"Terminated","Upstate New York Transplant Services","Buffalo","NY","US","Voluntary: Firm Initiated","Telephone","New York","B-2443-13","Class II","Platelets Pheresis Leukocytes Reduced","W280313700618 Part 1 ; W280313700618 Part 2; ",".","2","Blood products, which were labeled as leukoreduced, but were not tested to verify the White Blood Cell count, were distributed.",7/3/2013,"07/03/2013",10/30/2013,"10/30/2013"
"Biologics",65859,"Terminated","American National Red Cross","Columbus","OH","US","Voluntary: Firm Initiated","Other","California","B-2444-13","Class III","Blood and Blood Products for Reprocessing","16GQ57757; ",".","1","Blood product, collected from a donor for whom donor suitability was not adequately determined, was distributed.",6/14/2013,"06/14/2013",10/30/2013,"10/30/2013"
"Food",65860,"Ongoing","Superior Nut Co. Inc.","Cambridge","MA","US","Voluntary: Firm Initiated","E-Mail","Nationwide: AZ, AK, CA, CT, CO, DE, FL,HI, GA, IL, IN, LA, MA, MD, MI, MN, MT, NC, ND, NE, NH, NJ, NM, NL, NV, NY, OH, OK, PA, SC, SD, TN,TX, VA, WA, WV, WY Canada","F-1795-2013","Class I","Raw Pistachio Halves, 1 pound bag. Item Number 11910, UPC Code: 172043119107; Raw Pistachio Halves, 4 pound bag. Item Number 11911, UPC Code: 172043119114; Raw Pistachio Halves, 10 pound bag in box. Item Number 11912, UPC Code: 172043119121; Raw Pistachio Halves, 25 pound case, bag in box. Item Number 11913, UPC Code: 172043119138","Lot 024413 ",".","120 - 1 pound units; 52 - 4 pound bags; 32 - 10 lb. cases; 23 - 25 pound units","Positive laboratory result for Salmonella sp. Speciation in progress. ",8/1/2013,"08/01/2013",8/14/2013,"08/14/2013"
"Food",65861,"Ongoing","Whole Foods Market","Austin","TX","US","Voluntary: Firm Initiated","E-Mail","AZ, CA, HI, IL, IN, LA, MI, MO, NE, NV, OH, OK, TX, VA, Washington D.C., and WI","F-1851-2013","Class I","Trois Comtois Morbier Cheese labeled as follows: Morbier Raw Milk PLU 293358; Morbier AOC Le Trois PLU 293608; Morbier Raw Milk French Cheese PLU 293358; and Morbier Les Trois Comtois PLU 293608, Whole Foods Market","All best buy dates sold at Whole Food Market Stores in Louisiana, Oklahoma, Texas, Ohio, Virginia, Washington D.C., Illinois, Indiana, Michigan, Missouri, Nebraska, Wisconsin, California, Hawaii, Arizona, Nevada (Reno Store Only)",,"766 lbs","The product has the potential to be contaminated with Listeria monocytogenes. This recall is in response to the Trois Comtois in Poligny, France recall.",7/26/2013,"07/26/2013",9/4/2013,"09/04/2013"
"Devices",65862,"Ongoing","GE Healthcare, LLC","Waukesha","WI","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution - USA Nationwide in the states of AL, AK, AR, CA, CO, CT, FL, GA, HI, ID, IL IN, IA, KS, KY, LA, MD, MA, NMI, MN, MS, MO, NE, NV,NH,NJ, NM, NY, NC,ND, OH, OK OR, PA,SC, SD, TN, TX, UT, VA, WA, WV, WI, WY and the countries of CANADA, FRANCE GERMANY, GREAT BRITAIN ITALY, PANAMA, SAUDI ARABIA.","Z-1989-2013","Class II","GE Healthcare, Precision 500D Product Usage: The Precision 500D is designed to perform radiographic and fluoroscopic x-ray examinations. ","FMI# 10879: CRT Monitor Suspension Supporting Hardware Serial # 00000002608GQ8 00000002734GQ2 00000002735GQ9 00000002736GQ7 00000002838GQ1 00000003208GQ6 00000003209GQ4 00000004078GQ2 00000004079GQ0 00000004083GQ2 00000004084GQ0 00000004086GQ5 00000004087GQ3 00000004102GQ0 00000004103GQ8 00000004104GQ6 00000004105GQ3 00000004106GQ1 00000004107GQ9 00000004109GQ5 00000004873GQ6 00000004874GQ4 00000004875GQ1 00000004876GQ9 00000004878GQ5 00000004881GQ9 00000004882GQ7 00000005522GQ8 00000005523GQ6 00000005524GQ4 00000005525GQ1 00000005527GQ7 00000005528GQ5 00000005529GQ3 00000005530GQ1 00000005885GQ9 00000005886GQ7 00000005887GQ5 00000006565GQ6 00000006566GQ4 00000006742GQ1 00000006743GQ9 00000006744GQ7 00000006745GQ4 00000006746GQ2 00000006747GQ0 00000006748GQ8 00000006752GQ0 00000006753GQ8 00000006755GQ3 00000006756GQ1 00000006757GQ9 00000006758GQ7 00000007111GQ8 00000007112GQ6 00000007113GQ4 00000007114GQ2 00000007115GQ9 00000007116GQ7 00000007117GQ5 00000007118GQ3 00000007119GQ1 00000007121GQ7 00000007122GQ5 00000007123GQ3 00000007124GQ1 00000007125GQ8 00000007126GQ6 00000007127GQ4 00000007128GQ2 00000007130GQ8 00000007131GQ6 00000007132GQ4 00000007430GQ2 00000008338GQ6 00000008339GQ4 00000008340GQ2 00000008448GQ3 00000008449GQ1 00000008450GQ9 00000008451GQ7 00000008452GQ5 00000008453GQ3 00000008454GQ1 00000008455GQ8 00000008456GQ6 00000008713GQ0 00000008714GQ8 00000008715GQ5 00000008716GQ3 00000008717GQ1 00000008890GP6 00000008892GP2 00000009027GP4 00000009028GP2 00000009174GP4 00000009392GP2 00000009393GP0 00000009394GP8 00000009395GP5 00000009396GP3 00000009893GQ9 00000009894GQ7 00000009895GQ4 00000009896GQ2 00000009898GQ8 00000009900GQ2 00000009901GQ0 00000009903GQ6 00000009904GQ4 00000009905GQ1 00000009906GQ9 00000009907GQ7 00000009909GQ3 00000009910GQ1 00000009911GQ9 00000009912GQ7 00000010136GQ0 00000010137GQ8 00000010138GQ6 00000010139GQ4 00000010409GP1 00000010411GP7 00000010588GP2 00000010609GP6 00000010610GP4 00000010611GP2 00000010612GP0 00000010613GP8 00000011511GP3 00000011512GP1 00000011513GP9 0",".","445 (421 US, 24 OUS) ","GE Healthcare has recently become aware of a potential safety issue involving the overhead Video Monitor Suspension involving Precision 500D Systems. There is a potential for the locking nut to loosen out of the Video Monitor Suspension yoke which could result in impact. This will not lead to an immediate fall of the suspended monitor since it will be held in place by the remaining bushing and a screw in the absence of the locking-nut. To date, no complaint or injury has been reported due to this issue.",5/2/2013,"05/02/2013",8/28/2013,"08/28/2013"
"Devices",65863,"Ongoing","The Anspach Effort, Inc.","Palm Beach Gardens","FL","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution: USA Nationwide and the countries of: Egypt, India, Germany, Turkey, Canada, Saudi Arabia, Greece, United Kingdom, Cayman Islands, Kazakhstan, Republic of Korea, Taiwan, Hong Kong, China, Lebanon, Argentina, Denmark, Belgium, Netherlands, Mexico, France, Australia, Panama, Italy, Guam, United Arab Emirates, Israel, Polan, Venezuela, Austria, Hungary, Lithuania, Norway, Malaysia, Colombia, Costa Rica, Ecuador, Jamaica, Peru, Thailand, Italy, Czech Republic, Cameroon, South Africa, Portugal, Finland, Sweden, Nigeria, Bahamas, Cambodia, Dominican Republic, Switzerland, Chile, Singapore, Spain, Syrian Arab Republic, Jordan, Japan.","Z-0199-2014","Class II","Cutting Bur Chart (part number 20-0019) utilized with the Electric and Pneumatic Motor Systems including: MicroMax Motor Systems, XMax Motor Systems, EMax2 Motor Systems, and Emax2Plus Motor Systems, all models and serial numbers. Product Usage: Indication for use is cutting and shaping bone"," part number 20-0019",".","2,020","Anspach Effort, Inc. Palm Beach Gardens, FL initiated a correction of its medical Device labeling for its Pneumatic Systems Operating Manual, Cutting Burr Chart and Product Catalog due to a recent review of their regulations and compliance requirements that determined the claim that the device is capable of dissection of biometals, bioplastics and cement has been verified, but is is not part of the currently cleared indications for use fo the device(s). The currently cleared indications for use for the pnuematic and electric motor systems is ''cutting and shaping bone''.",5/6/2011,"05/06/2011",11/20/2013,"11/20/2013"
"Devices",65863,"Ongoing","The Anspach Effort, Inc.","Palm Beach Gardens","FL","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution: USA Nationwide and the countries of: Egypt, India, Germany, Turkey, Canada, Saudi Arabia, Greece, United Kingdom, Cayman Islands, Kazakhstan, Republic of Korea, Taiwan, Hong Kong, China, Lebanon, Argentina, Denmark, Belgium, Netherlands, Mexico, France, Australia, Panama, Italy, Guam, United Arab Emirates, Israel, Polan, Venezuela, Austria, Hungary, Lithuania, Norway, Malaysia, Colombia, Costa Rica, Ecuador, Jamaica, Peru, Thailand, Italy, Czech Republic, Cameroon, South Africa, Portugal, Finland, Sweden, Nigeria, Bahamas, Cambodia, Dominican Republic, Switzerland, Chile, Singapore, Spain, Syrian Arab Republic, Jordan, Japan.","Z-0200-2014","Class II","Product Catalog (part number 20-0020) utilized with the Electric and Pneumatic Motor Systems including: MicroMax Motor Systems, XMax Motor Systems, EMax2 Motor Systems, and Emax2Plus Motor Systems, all models and serial numbers. Product Usage: Indication for use is cutting and shaping bone.","part number 20-0020",".","2,020","Anspach Effort, Inc. Palm Beach Gardens, FL initiated a correction of its medical Device labeling for its Pneumatic Systems Operating Manual, Cutting Burr Chart and Product Catalog due to a recent review of their regulations and compliance requirements that determined the claim that the device is capable of dissection of biometals, bioplastics and cement has been verified, but is is not part of the currently cleared indications for use fo the device(s). The currently cleared indications for use for the pnuematic and electric motor systems is ''cutting and shaping bone''.",5/6/2011,"05/06/2011",11/20/2013,"11/20/2013"
"Devices",65863,"Ongoing","The Anspach Effort, Inc.","Palm Beach Gardens","FL","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution: USA Nationwide and the countries of: Egypt, India, Germany, Turkey, Canada, Saudi Arabia, Greece, United Kingdom, Cayman Islands, Kazakhstan, Republic of Korea, Taiwan, Hong Kong, China, Lebanon, Argentina, Denmark, Belgium, Netherlands, Mexico, France, Australia, Panama, Italy, Guam, United Arab Emirates, Israel, Polan, Venezuela, Austria, Hungary, Lithuania, Norway, Malaysia, Colombia, Costa Rica, Ecuador, Jamaica, Peru, Thailand, Italy, Czech Republic, Cameroon, South Africa, Portugal, Finland, Sweden, Nigeria, Bahamas, Cambodia, Dominican Republic, Switzerland, Chile, Singapore, Spain, Syrian Arab Republic, Jordan, Japan.","Z-0198-2014","Class II","Pneumatic Systems Operating Manual (part numbers 19-0005) utilized with the Pneumatic Motor Systems including: BlackMax Motor Systems, MicroMax Systems and XMax Motor Systems all models and serial numbers. Product Usage: Indication for use is cutting and shaping bone. ","part numbers 19-0005",".","2,020","Anspach Effort, Inc. Palm Beach Gardens, FL initiated a correction of its medical Device labeling for its Pneumatic Systems Operating Manual, Cutting Burr Chart and Product Catalog due to a recent review of their regulations and compliance requirements that determined the claim that the device is capable of dissection of biometals, bioplastics and cement has been verified, but is is not part of the currently cleared indications for use fo the device(s). The currently cleared indications for use for the pnuematic and electric motor systems is ''cutting and shaping bone''.",5/6/2011,"05/06/2011",11/20/2013,"11/20/2013"
"Food",65864,"Ongoing","Primex Intl Trading Corp","Los Angeles","CA","US","Voluntary: Firm Initiated","Telephone","NJ and MA","F-1794-2013","Class I","US Pistachio Shelled, Halves, Raw, Net Weight: 30lbs.","Lot#T0010092, expiry date: September 2014",".","477 units (14,310 lbs)","Primex International Trading Corp. is recalling Pistachios Shelled, Halves, because it has the potential to be contaminated with Salmonella.",7/30/2013,"07/30/2013",8/14/2013,"08/14/2013"
"Food",65864,"Terminated","Primex Intl Trading Corp","Los Angeles","CA","US","Voluntary: Firm Initiated","Telephone","NJ and MA","F-1794-2013","Class I","US Pistachio Shelled, Halves, Raw, Net Weight: 30lbs.","Lot#TO010092, expiry date: September 2014",".","477 units (14,310 lbs)","Primex International Trading Corp. is recalling Pistachios Shelled, Halves, because it has the potential to be contaminated with Salmonella.",7/30/2013,"07/30/2013",11/20/2013,"11/20/2013"
"Devices",65865,"Ongoing","Nidek Inc","Fremont","CA","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Nationwide US distribution only.","Z-2046-2013","Class II","NAVIS-EX , Image Filing Software for NIDEK AFC Fundus camera, Ver 1.1.0 to 1.3.5. NAVIS-EX is indicated for use as file management software for ophthalmic images.","version 1.1.0; serial numbers: 320823 320425 320622 121424 320094 320606 320617 320577 320636 320630 320468 320489 320518 320695 320695 320652 320666 320692 320675 320640 320492 320695 320704 320777 320779 320771 320768 320753 320744 320780 320617; version 1.2.1; serial numbers 320740 120045; Version 1.3.0: 141356 320814 320815 140941 141326 320847 320916 320906 320203 320569 320809 320813 141357 320831 140937 141358 320798 320090 320980 320990 320927 320942 320920 141401 320983; Version 1.3.4; 321035 321020 320998 141453; Version 1.3.5: 380215 380188 380189 380251 380211 380014 380077 380213 380076 380034 380035 380017 380244 380124 380243 380075 380122 380021 380253/380052 380221/380214 141480 141471 321053 320883. ",,"86","Under certain circumstances, the Left eye image may be saved as the Right eye image.",8/1/2013,"08/01/2013",9/4/2013,"09/04/2013"
"Devices",65866,"Ongoing","Getinge USA Inc","Rochester","NY","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution - USA and the country of Canada.","Z-1994-2013","Class II","Getinge Assure Accufast Biological Indicators, Catalog Number 61301606636 (50 Pack) and 61301606637 (100 Pack), STEAM --- Manufactured for: Getinge USA, Inc. 1777 E. Henrietta Rd., Rochester, NY 14623. Getinge Assure AccuFast Biological Indicators (BIs) are designed for biological testing of 121C, 132C, 134C and 135C steam sterilization cycles. The AccuFast BI is a self-contained biological indicator containing Geobacillus stearothermophilus inoculated on a paper carrier and placed in a plastic vial with a small glass ampule containing sterile culture medium. After activation, the plastic vial serves as a culture tube. The chemical indicator on the label changes from blue to black when exposed to steam, distinguishing exposed from unexposed units. This indicator does not indicate adequate sterilization.","LOT SR-430 (Expiration 02/06/2014)",".","Catalog # 61301606636: 78 Packs (3900 BIs); Catalog # 61301606637: 43 Packs (4300 BIs) ","AccuFast Biological Indicator Lot SR-430 may have been exposed to conditions affecting its viability. This could result in a false negative (or pass) when exposed to sub-lethal sterilization parameters.",8/2/2013,"08/02/2013",8/28/2013,"08/28/2013"
"Biologics",65867,"Terminated","OneBlood, Inc.","Miami","FL","US","Voluntary: Firm Initiated","Letter","Florida","B-2522-13","Class II","Red Blood Cells(Apheresis)","W036809423169; ",".","1","Blood products, collected from a donor for whom donor suitability was not adequately determined, were distributed.",7/19/2013,"07/19/2013",10/30/2013,"10/30/2013"
"Biologics",65867,"Terminated","OneBlood, Inc.","Miami","FL","US","Voluntary: Firm Initiated","Letter","Florida","B-2521-13","Class II","Fresh Frozen Plasma (Apheresis)","W036809423169; ",".","1","Blood products, collected from a donor for whom donor suitability was not adequately determined, were distributed.",7/19/2013,"07/19/2013",10/30/2013,"10/30/2013"
"Biologics",65867,"Terminated","OneBlood, Inc.","Miami","FL","US","Voluntary: Firm Initiated","Letter","Florida","B-2523-13","Class II","Platelets Pheresis Leukocytes Reduced","W036809423169; ",".","1","Blood products, collected from a donor for whom donor suitability was not adequately determined, were distributed.",7/19/2013,"07/19/2013",10/30/2013,"10/30/2013"
"Devices",65868,"Ongoing","Siemens Healthcare Diagnostics","Tarrytown","NY","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution - USA (nationwide) Puerto Rico and internationally to Argentina, Austria, Brazil, Bulgaria, Canada, Chile, China, Columbia, Croatia, Czech Republic, Denmark, Estonia, Finland, France, Germany, Great Britain, Greece, Guatemala, Hungary, Indonesia, Italy, Kazakhstan, Lithuania, Norway, Poland, Portugal, Romania, Russian Federation, Serbia, Singapore, Slovakia, Slovenia, Spain, Sweden, Switzerland, South Africa, South Korea, Thailand, Turkey, Uruguay, Vatican City, and Vietnam.","Z-2135-2013","Class II","ADVIA Chemistry A1c_3 Calibrators, Catalog Number 10491408, IVD --- COMMON/USUAL NAME: ADVIA Chemistry A1c_3 Calibrators Shipping or unit package: Level 1: 2 x 0.5 g; Level 2: 2 x 0.5 g; Level 3: 2 x 0.5 g; Level 4: 2 x 0.5 g -- Siemens Healthcare Diagnostics, Inc. Tarrytown, NY 10591 --- System Information: The ADVIA Chemistry systems are automated, clinical chemistry analyzers that can run tests on human serum, plasma, or urine in random access and batch modes for in vitro diagnostic use. For in vitro diagnostic use in the calibration of A1c_3 (A1c_3 and A1c_3M) and Total Hemoglobin_3 (tHb_3 and tHb_3M) methods on ADVIA Chemistry systems. ","Lots 1MD014 (exp. date 5/01/2013), 1BD063 (exp. 5/01/2013), 2GD014 (exp. 10/01/2014)",".","US: 1546 units; Foreign: 518 units","Siemens confirmed that the ADVIA Chemistry Systems HbA1c method exhibits a positive bias of up to 12% for patient and CAP survey samples due to over-recovery when using A1c_3 Calibrator lots 1MD014, 1BD063, and 2GD014. The established ranges of CAP Survey Samples GH2-04, GH2-05 and GH2-06 and IFCC sample recoveries use 7% from the established mean as their acceptance criteria. This is the criterion that was used during testing to confirm the customer complaints. Depending upon quality control limits this issue may not have been detected.. ",7/30/2013,"07/30/2013",9/11/2013,"09/11/2013"
"Devices",65869,"Ongoing","Sorin Group USA, Inc.","Arvada","CO","US","Voluntary: Firm Initiated","Letter","Nationwide Distribution","Z-1985-2013","Class II","Edwards Lifesciences Suction Wand Model S099B, packaged in Sorin Group Heart/Lung Perfusion Packs.","Model S099B",".","18,927 packs ","Sorin Group is recalling certain lots of Edwards Lifesciences Suction Wand Model S099B due to presence of plastic particles inside the pouch. ",7/8/2013,"07/08/2013",8/28/2013,"08/28/2013"
"Veterinary",65871,"Ongoing","Dogswell Llc","Los Angeles","CA","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","This product was distributed within the contiguous 48 states.","V-027-2014","Class III","Dogswell Veggie Life Happy Hips with Glucosamine & Chondroitin Chicken & Apple, 5oz, 15oz. Packaged: plastic pouches. Ingredients: Chicken Breast, Apple, Vitamin E Supplement, Glucosamine Hydrochloride, Chondroitin Sulfate.","UPCs 884244005102, 884244135151. All Lots with Best Before dates 1/28/2015 and earlier.",".",,"Dogswell, LLC initiated this recall of certain Dogswell and Catswell pet treats because they have the potential to contain trace amounts of an antibiotic that has not been approved for use in the United States. ",8/2/2013,"08/02/2013",12/26/2013,"12/26/2013"
"Veterinary",65871,"Ongoing","Dogswell Llc","Los Angeles","CA","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","This product was distributed within the contiguous 48 states.","V-018-2014","Class III","Catswell Happy Hips Chicken Breast Glucosamine & Chondroitin, 2oz. Packaged: plastic pouches. Ingredients:Chicken Breast, Glucosamine Hydrochloride, Chondroitin Sulfate, Vitamin E Supplement","UPC 884244000565 All Lots with Best Before dates 1/28/2015 and earlier.",".",,"Dogswell, LLC initiated this recall of certain Dogswell and Catswell pet treats because they have the potential to contain trace amounts of an antibiotic that has not been approved for use in the United States. ",8/2/2013,"08/02/2013",12/26/2013,"12/26/2013"
"Veterinary",65871,"Ongoing","Dogswell Llc","Los Angeles","CA","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","This product was distributed within the contiguous 48 states.","V-020-2014","Class III","Dogswell Happy Heart Chicken Breast with Flaxseed and Taurine, 5oz, 15oz. Packaged: plastic pouches. Ingredients: Chicken Breast, Vitamin E Supplement, Flaxseed, Taurine, Turmeric, Cinnamon, Dandelion Oil.","UPCs 884244112619, 884244115610 All Lots with Best Before dates 1/28/2015 and earlier.",".",,"Dogswell, LLC initiated this recall of certain Dogswell and Catswell pet treats because they have the potential to contain trace amounts of an antibiotic that has not been approved for use in the United States. ",8/2/2013,"08/02/2013",12/26/2013,"12/26/2013"
"Veterinary",65871,"Ongoing","Dogswell Llc","Los Angeles","CA","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","This product was distributed within the contiguous 48 states.","V-033-2014","Class III","Dogswell Vitality Minis Chicken Breast Flaxseed & Vitamins, 5oz, 15oz. Packaged: plastic pouches. Ingredients: Chicken Breast, Vegetable Glycerin, Vitamin E Supplement, Flaxseed, Vitamin A Acetate.","UPCs 884244112220, 884244115221. All Lots with Best Before dates 1/28/2015 and earlier.",".",,"Dogswell, LLC initiated this recall of certain Dogswell and Catswell pet treats because they have the potential to contain trace amounts of an antibiotic that has not been approved for use in the United States. ",8/2/2013,"08/02/2013",12/26/2013,"12/26/2013"
"Veterinary",65871,"Ongoing","Dogswell Llc","Los Angeles","CA","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","This product was distributed within the contiguous 48 states.","V-025-2014","Class III","Dogswell Mellow Mut Chicken Breast Natural with Added Vitamin E, 32oz. Packaged: plastic pouches. Ingredients: Chicken Breast, Vitamin E Supplement, Chamomile, Clover, Lavender, Lemon Balm, Linden Flower, Oyster Shell Flour (Source of Calcium Carbonate).","UPC 884244118512. All Lots with Best Before dates 1/28/2015 and earlier.",".",,"Dogswell, LLC initiated this recall of certain Dogswell and Catswell pet treats because they have the potential to contain trace amounts of an antibiotic that has not been approved for use in the United States. ",8/2/2013,"08/02/2013",12/26/2013,"12/26/2013"
"Veterinary",65871,"Ongoing","Dogswell Llc","Los Angeles","CA","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","This product was distributed within the contiguous 48 states.","V-017-2014","Class III","Catswell Breathies Chicken Breast with Mint & Parsley, 2oz. Packaged: plastic pouches. Ingredients:Chicken Breast, Flaxseed, Vitamin E Supplement, Mint, Cinnamon Bark, Oyster Shell Flour (Source of Calcium Carbonate), Rosemary, Parsley, Chlorophyll","UPC 884244000589 All Lots with Best Before dates 1/28/2015 and earlier.",".",,"Dogswell, LLC initiated this recall of certain Dogswell and Catswell pet treats because they have the potential to contain trace amounts of an antibiotic that has not been approved for use in the United States. ",8/2/2013,"08/02/2013",12/26/2013,"12/26/2013"
"Veterinary",65871,"Ongoing","Dogswell Llc","Los Angeles","CA","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","This product was distributed within the contiguous 48 states.","V-030-2014","Class III","Dogswell Veggie Life Vitality with Flaxseed & Vitamins Chicken & Apple, 5oz, 15oz. Packaged: plastic pouches. Ingredients: Chicken Breast, Apple, Vitamin E Supplement, Flaxseed, Vitamin A Acetate.","UPCs 884244005119, 884244135250. All Lots with Best Before dates 1/28/2015 and earlier.",".",,"Dogswell, LLC initiated this recall of certain Dogswell and Catswell pet treats because they have the potential to contain trace amounts of an antibiotic that has not been approved for use in the United States. ",8/2/2013,"08/02/2013",12/26/2013,"12/26/2013"
"Veterinary",65871,"Ongoing","Dogswell Llc","Los Angeles","CA","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","This product was distributed within the contiguous 48 states.","V-023-2014","Class III","Dogswell Mellow Mut Chicken Breast, 5oz. Packaged: plastic pouches. Ingredients: Chicken Breast, Vitamin E Supplement, Chamomile, Clover Lavender, Lemon Balm, Linden Flower, Oyster Shell Flour (Source of Calcium Carbonate).","UPC 884244112510. All Lots with Best Before dates 1/28/2015 and earlier.",".",,"Dogswell, LLC initiated this recall of certain Dogswell and Catswell pet treats because they have the potential to contain trace amounts of an antibiotic that has not been approved for use in the United States. ",8/2/2013,"08/02/2013",12/26/2013,"12/26/2013"
"Veterinary",65871,"Ongoing","Dogswell Llc","Los Angeles","CA","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","This product was distributed within the contiguous 48 states.","V-032-2014","Class III","Dogswell Veggie Life Vitality with Flaxseed & Vitamins Chicken & Sweet Potato, 5oz, 15oz. Packaged: plastic pouches. Ingredients: Chicken Breast, Sweet Potato, Vitamin E Supplement, Flaxseed, Vitamin A Acetate.","UPCs 884244005058, 884244135236. All Lots with Best Before dates 1/28/2015 and earlier.",".",,"Dogswell, LLC initiated this recall of certain Dogswell and Catswell pet treats because they have the potential to contain trace amounts of an antibiotic that has not been approved for use in the United States. ",8/2/2013,"08/02/2013",12/26/2013,"12/26/2013"
"Veterinary",65871,"Ongoing","Dogswell Llc","Los Angeles","CA","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","This product was distributed within the contiguous 48 states.","V-016-2014","Class III","Dogswell Breathies Duck Breast with Mint & Parsley, 5oz, 15oz. Packaged: plastic pouches. Ingredients: Duck Breast, Vitamin E Supplement, Mint, Cinnamon Bark, Oyster Shell Flour (Source of Calcium Carbonate), Rosemary, Parsley, Chlorophyll","UPCs 884244112435, 884244115436 All Lots with Best Before dates 1/28/2015 and earlier.",".",,"Dogswell, LLC initiated this recall of certain Dogswell and Catswell pet treats because they have the potential to contain trace amounts of an antibiotic that has not been approved for use in the United States. ",8/2/2013,"08/02/2013",12/26/2013,"12/26/2013"
"Veterinary",65871,"Ongoing","Dogswell Llc","Los Angeles","CA","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","This product was distributed within the contiguous 48 states.","V-014-2014","Class III","Dogswell Breathies Minis Chicken Breast Mint & Parsley, 5 oz. Packaged: plastic pouches. Ingredients: Chicken Breast, Vitamin E Supplement, Mint, Cinnamon Bark, Oyster Shell Flour (Source of Calcium Carbonate), Rosemary, Parsley, Chlorophyll.","UPC 884244112428 All Lots with Best Before dates 1/28/2015 and earlier.",".",,"Dogswell, LLC initiated this recall of certain Dogswell and Catswell pet treats because they have the potential to contain trace amounts of an antibiotic that has not been approved for use in the United States. ",8/2/2013,"08/02/2013",12/26/2013,"12/26/2013"
"Veterinary",65871,"Ongoing","Dogswell Llc","Los Angeles","CA","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","This product was distributed within the contiguous 48 states.","V-034-2014","Class III","Dogswell Vitality Chicken Breast with Flaxseed & Vitamins, 5oz, 15oz, 32oz. Packaged: plastic pouches. Ingredients: Chicken Breast, Vegetable Glycerin, Vitamin E Supplement, Flaxseed, Vitamin A Acetate.","UPCs 884244112213, 884244115214, 884244118215. All Lots with Best Before dates 1/28/2015 and earlier.",".",,"Dogswell, LLC initiated this recall of certain Dogswell and Catswell pet treats because they have the potential to contain trace amounts of an antibiotic that has not been approved for use in the United States. ",8/2/2013,"08/02/2013",12/26/2013,"12/26/2013"
"Veterinary",65871,"Ongoing","Dogswell Llc","Los Angeles","CA","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","This product was distributed within the contiguous 48 states.","V-026-2014","Class III","Dogswell Shape Up Chicken Breast with LCarnitine, 5oz, 15oz. Packaged: plastic pouches. Ingredients: Chicken Breast, Vitamin E Supplement, LCarnitine, Dried Kelp, Dandelion Oil, Ginger, Turmeric.","UPCs 884244112817, 884244115818. All Lots with Best Before dates 1/28/2015 and earlier.",".",,"Dogswell, LLC initiated this recall of certain Dogswell and Catswell pet treats because they have the potential to contain trace amounts of an antibiotic that has not been approved for use in the United States. ",8/2/2013,"08/02/2013",12/26/2013,"12/26/2013"
"Veterinary",65871,"Ongoing","Dogswell Llc","Los Angeles","CA","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","This product was distributed within the contiguous 48 states.","V-019-2014","Class III","Catswell Vitakitty Chicken Breast with Flaxseed & Vitamin A, 2oz. Packaged: plastic pouches. Ingredients: Chicken Breast, Vitamin E Supplement, Flaxseed, Vitamin A Acetate.","UPC 884244000572 All Lots with Best Before dates 1/28/2015 and earlier.",".",,"Dogswell, LLC initiated this recall of certain Dogswell and Catswell pet treats because they have the potential to contain trace amounts of an antibiotic that has not been approved for use in the United States. ",8/2/2013,"08/02/2013",12/26/2013,"12/26/2013"
"Veterinary",65871,"Ongoing","Dogswell Llc","Los Angeles","CA","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","This product was distributed within the contiguous 48 states.","V-035-2014","Class III","Dogswell Vitality Duck Breast with Flaxseed & Vitamins, 5oz, 15oz. Packaged: plastic pouches. Ingredients: Duck Breast, Vegetable Glycerin, Vitamin E Supplement, Flaxseed, Vitamin A Acetate.","UPCs 884244112237, 884244115238. All Lots with Best Before dates 1/28/2015 and earlier.",".",,"Dogswell, LLC initiated this recall of certain Dogswell and Catswell pet treats because they have the potential to contain trace amounts of an antibiotic that has not been approved for use in the United States. ",8/2/2013,"08/02/2013",12/26/2013,"12/26/2013"
"Veterinary",65871,"Ongoing","Dogswell Llc","Los Angeles","CA","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","This product was distributed within the contiguous 48 states.","V-022-2014","Class III","Dogswell Happy Hips Duck Breast Glucosamine & Chondroitin, 5oz, 15oz, 32oz. Packaged: plastic pouches. Ingredients: Duck Breast, Vegetable Glycerin, Vitamin E Supplement, Glucosamine Hydrochloride, Chondroitin Sulfate.","UPCs 884244112138, 884244115139, 884244118130. All Lots with Best Before dates 1/28/2015 and earlier.",".",,"Dogswell, LLC initiated this recall of certain Dogswell and Catswell pet treats because they have the potential to contain trace amounts of an antibiotic that has not been approved for use in the United States. ",8/2/2013,"08/02/2013",12/26/2013,"12/26/2013"
"Veterinary",65871,"Ongoing","Dogswell Llc","Los Angeles","CA","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","This product was distributed within the contiguous 48 states.","V-029-2014","Class III","Dogswell Veggie Life Happy Hips with Glucosamine & Chondroitin Chicken & Sweet Potato, 5oz, 15oz. Packaged: plastic pouches. Ingredients: Chicken Breast, Sweet Potato, Vitamin E Supplement, Glucosamine Hydrochloride, Chondroitin Sulfate.","UPCs 884244005041, 884244135137. All Lots with Best Before dates 1/28/2015 and earlier.",".",,"Dogswell, LLC initiated this recall of certain Dogswell and Catswell pet treats because they have the potential to contain trace amounts of an antibiotic that has not been approved for use in the United States. ",8/2/2013,"08/02/2013",12/26/2013,"12/26/2013"
"Veterinary",65871,"Ongoing","Dogswell Llc","Los Angeles","CA","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","This product was distributed within the contiguous 48 states.","V-028-2014","Class III","Dogswell Veggie Life Happy Hips with Glucosamine & Chondroitin Chicken & Banana, 5oz, 15oz. Packaged: plastic pouches. Ingredients: Chicken Breast, Banana, Vitamin E Supplement, Glucosamine Hydrochloride, Chondroitin Sulfate.","UPCs 884244005089, 884244135144. All Lots with Best Before dates 1/28/2015 and earlier.",".",,"Dogswell, LLC initiated this recall of certain Dogswell and Catswell pet treats because they have the potential to contain trace amounts of an antibiotic that has not been approved for use in the United States. ",8/2/2013,"08/02/2013",12/26/2013,"12/26/2013"
"Veterinary",65871,"Ongoing","Dogswell Llc","Los Angeles","CA","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","This product was distributed within the contiguous 48 states.","V-031-2014","Class III","Dogswell Veggie Life Vitality with Flaxseed & Vitamins Chicken & Banana, 5oz, 15oz. Packaged: plastic pouches. Ingredients: Chicken Breast, Banana, Vitamin E Supplement, Flaxseed, Vitamin A Acetate.","UPCs 884244005096, 884244135243. All Lots with Best Before dates 1/28/2015 and earlier.",".",,"Dogswell, LLC initiated this recall of certain Dogswell and Catswell pet treats because they have the potential to contain trace amounts of an antibiotic that has not been approved for use in the United States. ",8/2/2013,"08/02/2013",12/26/2013,"12/26/2013"
"Veterinary",65871,"Ongoing","Dogswell Llc","Los Angeles","CA","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","This product was distributed within the contiguous 48 states.","V-024-2014","Class III","Dogswell Mellow Mut Chicken Breast Chamomile & Lavender, 15oz. Packaged: plastic pouches. Ingredients: Chicken Breast, Vitamin E Supplement, Chamomile, Clover, Lavender, Lemon Balm, Linden Flower, Oyster Shell Flour (Source of Calcium Carbonate)","UPC 884244115511. All Lots with Best Before dates 1/28/2015 and earlier.",".",,"Dogswell, LLC initiated this recall of certain Dogswell and Catswell pet treats because they have the potential to contain trace amounts of an antibiotic that has not been approved for use in the United States. ",8/2/2013,"08/02/2013",12/26/2013,"12/26/2013"
"Veterinary",65871,"Ongoing","Dogswell Llc","Los Angeles","CA","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","This product was distributed within the contiguous 48 states.","V-015-2014","Class III","Dogswell Breathies Chicken Breast with Mint & Parsley, 5oz, 15oz, 32oz. Packaged: plastic pouches. Ingredients: Chicken Breast, Vitamin E Supplement, Mint, Cinnamon Bark, Oyster Shell Flour (Source of Calcium Carbonate), Rosemary, Parsley, Chlorophyll","UPCs 884244112411, 884244115412, 884244118413 All Lots with Best Before dates 1/28/2015 and earlier.",".",,"Dogswell, LLC initiated this recall of certain Dogswell and Catswell pet treats because they have the potential to contain trace amounts of an antibiotic that has not been approved for use in the United States. ",8/2/2013,"08/02/2013",12/26/2013,"12/26/2013"
"Veterinary",65871,"Ongoing","Dogswell Llc","Los Angeles","CA","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","This product was distributed within the contiguous 48 states.","V-021-2014","Class III","Dogswell Happy Hips Chicken Breast Glucosamine & Chondroitin, 5oz, 15oz, 32oz. Packaged: plastic pouches. Ingredients: Chicken Breast, Vegetable Glycerin, Vitamin E Supplement, Glucosamine Hydrochloride, Chondroitin Sulfate.","UPCs 884244112114, 884244115115, 884244001005 All Lots with Best Before dates 1/28/2015 and earlier.",".",,"Dogswell, LLC initiated this recall of certain Dogswell and Catswell pet treats because they have the potential to contain trace amounts of an antibiotic that has not been approved for use in the United States. ",8/2/2013,"08/02/2013",12/26/2013,"12/26/2013"
"Food",65872,"Ongoing","Les 3 Comtois","Poligny",,"FR","Voluntary: Firm Initiated","Letter","CA, IL, & WI","F-1850-2013","Class I","Morbier Les 3 Comtois, 11 lb. wheel; packaged in a cardboard case; one per case; refrigerated","949038",,"83 cases","FDA analysis of Morbier Semi-Soft Cheese (prior to entry) revealed the presence of Listeria Monocytogenes. Les 3 Comtois is recalling the cheese from the same lot that was allowed entry and further distributed in the US.",7/31/2013,"07/31/2013",9/4/2013,"09/04/2013"
"Food",65873,"Terminated","La Terra Fina USA, Inc.","Union City","CA","US","Voluntary: Firm Initiated","E-Mail","CA, CO, TX, IN..","F-1869-2013","Class III","Chunky Spinach Artichoke and Parmesan Dip: Gluten Free, Trans Fat Free. Net WT. 10 oz., (.625 lb,284g Made with real cream cheese. Plastic square tub La Terra Fina Union City, CA 94587","Best By SEP-02-2013",".","1130 cases (6/10 oz tubs per carton)","One lot Spinach Artichoke & Parmesan dip contains the ingredient and nutrition information for Caramelized onion dip. Both dips have the same allergens statement - Milk, Soy and Egg.",8/2/2013,"08/02/2013",9/11/2013,"09/11/2013"
"Devices",65874,"Ongoing","Celera Corporation","Alameda","CA","US","Voluntary: Firm Initiated","Letter","USA Nationwide in the state of CA","Z-2096-2013","Class III","OLA Buffer For Laboratory Use; Contents: 1 tube with buffered solution containing MgCl2 (80 M) and KCL (300 M. 10.0ml.) PN: 50003300; Store at d - 15C. Product Usage: General Purpose Reagent for laboratory use.","Lot numbers: 10016853, 10017390, 10020343, 10021820 and 10022594. Expiry dates 12/5/2010, 06/15/2012, 09/08,2012, 08/13/2013 and 02/21/2014.",,"43 units","The package insert for FG OLA Buffer, GPR displayed the wrong concentration of M instead of the correct mM unit.",7/12/2013,"07/12/2013",9/4/2013,"09/04/2013"
"Drugs",65876,"Ongoing","Beacon Hill Medical Pharmacy, P.C.","Southfield","MI","US","Voluntary: Firm Initiated","Telephone","USA nationwide","D-978-2013","Class II","METHYLCOBALAMIN 1 mg/ml, 5 mg/ml, 10 mg/ml, 25 mg/ml and METHYLCOBALAMIN (PF) 1 MG/ML, 25 MG/ML INJ SOLN, all presentations, FOR INTRAVENO and SQ USE ONLY, STERILE, RX ONLY, Compounded by Beacon Hill Medical Pharmacy PC, dba Rxtra Solutions, Southfield, MI","04222013@14, 06052013@35, 07242013@8, 07242013@13, 04082013@11, 04292013@13, 02272013@9, 05212013@39, 03272013@28, 07032013@16, 02272013@8 ",".",,"Lack of Assurance of Sterility; FDA inspectional findings resulted in concerns associated with quality control procedures that impacted sterility assurance",7/26/2013,"07/26/2013",9/18/2013,"09/18/2013"
"Drugs",65876,"Ongoing","Beacon Hill Medical Pharmacy, P.C.","Southfield","MI","US","Voluntary: Firm Initiated","Telephone","USA nationwide","D-995-2013","Class II","QUAD AMINO BLEND 150/75/150/75 MG/ML INJECTABLE, all presentations, FOR INTRAVENO AND SQ USE ONLY, STERILE, RX ONLY, Compounded by Beacon Hill Medical Pharmacy PC, dba Rxtra Solutions, Southfield, MI","07162013@27 06262013@38 07102013@27 ",".",,"Lack of Assurance of Sterility; FDA inspectional findings resulted in concerns associated with quality control procedures that impacted sterility assurance",7/26/2013,"07/26/2013",9/18/2013,"09/18/2013"
"Drugs",65876,"Ongoing","Beacon Hill Medical Pharmacy, P.C.","Southfield","MI","US","Voluntary: Firm Initiated","Telephone","USA nationwide","D-963-2013","Class II","GLUTATHIONE/METHYL/LIDO 100/25/20 MG/ML INJ SOLN and GLUTATHIONE/METHYL/LIDO 100/25/20MG/ML (PF) INJ SOLN, all presentations, FOR INTRAVENO and SQ USE ONLY, STERILE, RX ONLY, Compounded by Beacon Hill Medical Pharmacy PC, dba Rxtra Solutions, Southfield, MI","06132013@6 04242013@33 ",".",,"Lack of Assurance of Sterility; FDA inspectional findings resulted in concerns associated with quality control procedures that impacted sterility assurance",7/26/2013,"07/26/2013",9/18/2013,"09/18/2013"
"Drugs",65876,"Ongoing","Beacon Hill Medical Pharmacy, P.C.","Southfield","MI","US","Voluntary: Firm Initiated","Telephone","USA nationwide","D-959-2013","Class II","FUROSEMIDE 10 MG/ML INJECTABLE, all presentations, FOR INTRAVENO AND SQ USE ONLY, STERILE, RX ONLY, Compounded by Beacon Hill Medical Pharmacy PC, dba Rxtra Solutions, Southfield, MI","01162013@14, 02132013@18 ",".",,"Lack of Assurance of Sterility; FDA inspectional findings resulted in concerns associated with quality control procedures that impacted sterility assurance",7/26/2013,"07/26/2013",9/18/2013,"09/18/2013"
"Drugs",65876,"Ongoing","Beacon Hill Medical Pharmacy, P.C.","Southfield","MI","US","Voluntary: Firm Initiated","Telephone","USA nationwide","D-1016-2013","Class II","CALCIUM EDTA 200 MG/ML INJECTABLE, all configurations, FOR INTRAVENO AND SQ USE ONLY, STERILE, RX ONLY, Compounded by Beacon Hill Medical Pharmacy PC, dba Rxtra Solutions, Southfield, MI","02112013@14 and 04102013@25",".",,"Lack of Assurance of Sterility; FDA inspectional findings resulted in concerns associated with quality control procedures that impacted sterility assurance",7/26/2013,"07/26/2013",9/18/2013,"09/18/2013"
"Drugs",65876,"Ongoing","Beacon Hill Medical Pharmacy, P.C.","Southfield","MI","US","Voluntary: Firm Initiated","Telephone","USA nationwide","D-972-2013","Class II","L-TRYPTOPHAN 300 MG/ML INJECTABLE, all presentations, FOR INTRAVENO and SQ USE ONLY, STERILE, RX ONLY, Compounded by Beacon Hill Medical Pharmacy PC, dba Rxtra Solutions, Southfield, MI","02282013@12",".",,"Lack of Assurance of Sterility; FDA inspectional findings resulted in concerns associated with quality control procedures that impacted sterility assurance",7/26/2013,"07/26/2013",9/18/2013,"09/18/2013"
"Drugs",65876,"Ongoing","Beacon Hill Medical Pharmacy, P.C.","Southfield","MI","US","Voluntary: Firm Initiated","Telephone","USA nationwide","D-940-2013","Class II","B12/E2/E3/PROG/TEST 1/3.75/2.5/50/45 MG/ML OIL INJ SOLN, all presentations, FOR INTRAVENO AND SQ USE ONLY, STERILE, RX ONLY, Compounded by Beacon Hill Medical Pharmacy PC, dba Rxtra Solutions, Southfield, MI","03202013@31",".",,"Lack of Assurance of Sterility; FDA inspectional findings resulted in concerns associated with quality control procedures that impacted sterility assurance.",7/26/2013,"07/26/2013",9/18/2013,"09/18/2013"
"Drugs",65876,"Ongoing","Beacon Hill Medical Pharmacy, P.C.","Southfield","MI","US","Voluntary: Firm Initiated","Telephone","USA nationwide","D-973-2013","Class II","LIDOCAINE MDV 1% INJECTABLE, LIDOCAINE MDV 20 MG/ML INJECTABLE and Lidocaine PF 20 MG/ML INJECTABLE, all presentations, FOR INTRAVENO and SQ USE ONLY, STERILE, RX ONLY, Compounded by Beacon Hill Medical Pharmacy PC, dba Rxtra Solutions, Southfield, MI","02262013@10, 03062013@29, 06252013@17, 07092013@18, 05092013@14 ",".",,"Lack of Assurance of Sterility; FDA inspectional findings resulted in concerns associated with quality control procedures that impacted sterility assurance",7/26/2013,"07/26/2013",9/18/2013,"09/18/2013"
"Drugs",65876,"Ongoing","Beacon Hill Medical Pharmacy, P.C.","Southfield","MI","US","Voluntary: Firm Initiated","Telephone","USA nationwide","D-942-2013","Class II","BI-TROPIN S-2 INJECTABLE, all presentations, FOR INTRAVENO AND SQ USE ONLY, STERILE, RX ONLY, Compounded by Beacon Hill Medical Pharmacy PC, dba Rxtra Solutions, Southfield, MI","01242013@2, 04172013@8, 05242013@7, 07152013@9 ",".",,"Lack of Assurance of Sterility; FDA inspectional findings resulted in concerns associated with quality control procedures that impacted sterility assurance",7/26/2013,"07/26/2013",9/18/2013,"09/18/2013"
"Drugs",65876,"Ongoing","Beacon Hill Medical Pharmacy, P.C.","Southfield","MI","US","Voluntary: Firm Initiated","Telephone","USA nationwide","D-933-2013","Class II","ACETYLCYSTEINE 100 MG/ML INJ SOLN, all presentations, FOR INTRAVENO AND SQ USE ONLY, STERILE, RX ONLY, Compounded by Beacon Hill Medical Pharmacy PC, dba Rxtra Solutions, Southfield, MI ","06252013@14",".",,"Lack of Assurance of Sterility; FDA inspectional findings resulted in concerns associated with quality control procedures that impacted sterility assurance",7/26/2013,"07/26/2013",9/18/2013,"09/18/2013"
"Drugs",65876,"Ongoing","Beacon Hill Medical Pharmacy, P.C.","Southfield","MI","US","Voluntary: Firm Initiated","Telephone","USA nationwide","D-957-2013","Class II","ESTRIOL 5 MG/ML OIL INJ SOLN, all presentations, FOR INTRAVENO AND SQ USE ONLY, STERILE, RX ONLY, Compounded by Beacon Hill Medical Pharmacy PC, dba Rxtra Solutions, Southfield, MI","02042013@21, 02262013@3, 07242013@38 ",".",,"Lack of Assurance of Sterility; FDA inspectional findings resulted in concerns associated with quality control procedures that impacted sterility assurance",7/26/2013,"07/26/2013",9/18/2013,"09/18/2013"
"Drugs",65876,"Ongoing","Beacon Hill Medical Pharmacy, P.C.","Southfield","MI","US","Voluntary: Firm Initiated","Telephone","USA nationwide","D-983-2013","Class II","NALBUPHINE HCL 20 MG/ML INJECTABLE, all presentations, FOR INTRAVENO and SQ USE ONLY, STERILE, RX ONLY, Compounded by Beacon Hill Medical Pharmacy PC, dba Rxtra Solutions, Southfield, MI","03282013@8, 02282013@2, 04012013@22, 05022013@22, 05012013@38 ",".",,"Lack of Assurance of Sterility; FDA inspectional findings resulted in concerns associated with quality control procedures that impacted sterility assurance",7/26/2013,"07/26/2013",9/18/2013,"09/18/2013"
"Drugs",65876,"Ongoing","Beacon Hill Medical Pharmacy, P.C.","Southfield","MI","US","Voluntary: Firm Initiated","Telephone","USA nationwide","D-989-2013","Class II","POTASSIUM CHLORIDE 2 MEQ/ML INJECTABLE, all presentations, FOR INTRAVENO AND SQ USE ONLY, STERILE, RX ONLY, Compounded by Beacon Hill Medical Pharmacy PC, dba Rxtra Solutions, Southfield, MI","05072013@26 ",".",,"Lack of Assurance of Sterility; FDA inspectional findings resulted in concerns associated with quality control procedures that impacted sterility assurance",7/26/2013,"07/26/2013",9/18/2013,"09/18/2013"
"Drugs",65876,"Ongoing","Beacon Hill Medical Pharmacy, P.C.","Southfield","MI","US","Voluntary: Firm Initiated","Telephone","USA nationwide","D-1001-2013","Class II","SODIUM PHOSPHATE MONOBASIC/WATER FOR INJECTION 10%, all presentations, FOR INTRAVENO AND SQ USE ONLY, STERILE, RX ONLY, Compounded by Beacon Hill Medical Pharmacy PC, dba Rxtra Solutions, Southfield, MI","01242013@5",".",,"Lack of Assurance of Sterility; FDA inspectional findings resulted in concerns associated with quality control procedures that impacted sterility assurance",7/26/2013,"07/26/2013",9/18/2013,"09/18/2013"
"Drugs",65876,"Ongoing","Beacon Hill Medical Pharmacy, P.C.","Southfield","MI","US","Voluntary: Firm Initiated","Telephone","USA nationwide","D-996-2013","Class II","SELENIUM 400 MCG/ML INJECTABLE, all presentations, FOR INTRAVENO AND SQ USE ONLY, STERILE, RX ONLY, Compounded by Beacon Hill Medical Pharmacy PC, dba Rxtra Solutions, Southfield, MI","03282013@4",".",,"Lack of Assurance of Sterility; FDA inspectional findings resulted in concerns associated with quality control procedures that impacted sterility assurance",7/26/2013,"07/26/2013",9/18/2013,"09/18/2013"
"Drugs",65876,"Ongoing","Beacon Hill Medical Pharmacy, P.C.","Southfield","MI","US","Voluntary: Firm Initiated","Telephone","USA nationwide","D-994-2013","Class II","PYRIDOXINE HCL P/F 100 MG/ML INJECTABLE, all presentations, FOR INTRAVENO AND SQ USE ONLY, STERILE, RX ONLY, Compounded by Beacon Hill Medical Pharmacy PC, dba Rxtra Solutions, Southfield, MI","03262013@2, 06252013@16 ",".",,"Lack of Assurance of Sterility; FDA inspectional findings resulted in concerns associated with quality control procedures that impacted sterility assurance",7/26/2013,"07/26/2013",9/18/2013,"09/18/2013"
"Drugs",65876,"Ongoing","Beacon Hill Medical Pharmacy, P.C.","Southfield","MI","US","Voluntary: Firm Initiated","Telephone","USA nationwide","D-1005-2013","Class II","TRI-MIX 10 MCG/30 MG/1 MG/ML INJ SOLN and TRI-MIX 30 MCG/15 MG/2 MG/ML INJ SOLN, all configuration, FOR INTRAVENO AND SQ USE ONLY, STERILE, RX ONLY, Compounded by Beacon Hill Medical Pharmacy PC, dba Rxtra Solutions, Southfield, MI","04302013@22, 02132013@8, 04122013@27, 06262013@28 ",".",,"Lack of Assurance of Sterility; FDA inspectional findings resulted in concerns associated with quality control procedures that impacted sterility assurance",7/26/2013,"07/26/2013",9/18/2013,"09/18/2013"
"Drugs",65876,"Ongoing","Beacon Hill Medical Pharmacy, P.C.","Southfield","MI","US","Voluntary: Firm Initiated","Telephone","USA nationwide","D-950-2013","Class II","DMSO 50% INJ 50 ML VIAL INJECTABLE, all presentations, FOR INTRAVENO AND SQ USE ONLY, STERILE, RX ONLY, Compounded by Beacon Hill Medical Pharmacy PC, dba Rxtra Solutions, Southfield, MI","07162013@16 and 02262013@9",".",,"Lack of Assurance of Sterility; FDA inspectional findings resulted in concerns associated with quality control procedures that impacted sterility assurance",7/26/2013,"07/26/2013",9/18/2013,"09/18/2013"
"Drugs",65876,"Ongoing","Beacon Hill Medical Pharmacy, P.C.","Southfield","MI","US","Voluntary: Firm Initiated","Telephone","USA nationwide","D-991-2013","Class II","PROG/TEST CYP 15/7.5 MG/ML OIL INJ SOLN, all presentations, FOR INTRAVENO AND SQ USE ONLY, STERILE, RX ONLY, Compounded by Beacon Hill Medical Pharmacy PC, dba Rxtra Solutions, Southfield, MI","05012013@23, 06202013@20 ",".",,"Lack of Assurance of Sterility; FDA inspectional findings resulted in concerns associated with quality control procedures that impacted sterility assurance",7/26/2013,"07/26/2013",9/18/2013,"09/18/2013"
"Drugs",65876,"Ongoing","Beacon Hill Medical Pharmacy, P.C.","Southfield","MI","US","Voluntary: Firm Initiated","Telephone","USA nationwide","D-1009-2013","Class II","VITAMIN B-COMPLEX INJECTABLE, VITAMIN B-COMPLEX SL SOLN and VITAMIN B-COMPLEX (PF) INJECTABLE, all configurations, FOR INTRAVENO AND SQ USE ONLY, STERILE, RX ONLY, Compounded by Beacon Hill Medical Pharmacy PC, dba Rxtra Solutions, Southfield, MI","07022013@37, 01152013@32, 03012013@22, 03062013@15, 03122013@14, 04102013@4, 04242013@14, 04302013@2, 05242013@9, 06122013@26, 06122013@20, 07112013@16, 07232013@2 ",".",,"Lack of Assurance of Sterility; FDA inspectional findings resulted in concerns associated with quality control procedures that impacted sterility assurance",7/26/2013,"07/26/2013",9/18/2013,"09/18/2013"
"Drugs",65876,"Ongoing","Beacon Hill Medical Pharmacy, P.C.","Southfield","MI","US","Voluntary: Firm Initiated","Telephone","USA nationwide","D-966-2013","Class II","H.C.G. (COMPOUNDED), 5,000, 8, 000, 10,000, 11,000 and 12,000 UNIT VIALS INJECTABLE, all presentations, FOR INTRAVENO and SQ USE ONLY, STERILE, RX ONLY, Compounded by Beacon Hill Medical Pharmacy PC, dba Rxtra Solutions, Southfield, MI","01242013@23, 03132013@20, 04232013@21, 06112013@31, 03282013@24, 02042013@9, 03092013@6, 04122013@10, 04232013@24, 05232013@8, 06192013@26, 07102013@18, 07132013@6, 01072013@3, 02192013@10, 04172013@23, 06192013@28, 07102013@15, 07132013@8, 03232013@4, 03282013@22, 01032013@5, 01182013@24, 02052013@8, 03062013@5, 04122013@4, 04232013@26, 05132013@15, 05232013@5, 06182013@31, 06212013@12, 07132013@4, 03282013@27, 01032013@3, 01242013@16, 02192013@7, 03062013@2, 04122013@8, 04232013@29, 05232013@10, 06112013@28, 06182013@36, and 06242013@21.",".",,"Lack of Assurance of Sterility; FDA inspectional findings resulted in concerns associated with quality control procedures that impacted sterility assurance",7/26/2013,"07/26/2013",9/18/2013,"09/18/2013"
"Drugs",65876,"Ongoing","Beacon Hill Medical Pharmacy, P.C.","Southfield","MI","US","Voluntary: Firm Initiated","Telephone","USA nationwide","D-1006-2013","Class II","TRIAMCINOLONE ACETONIDE 80 MG/ML INJ SUSP, all configurations, FOR INTRAVENO AND SQ USE ONLY, STERILE, RX ONLY, Compounded by Beacon Hill Medical Pharmacy PC, dba Rxtra Solutions, Southfield, MI","03252013@20, 04152013@11, 05232013@25, 06052013@32, 07022013@24 ",".",,"Lack of Assurance of Sterility; FDA inspectional findings resulted in concerns associated with quality control procedures that impacted sterility assurance",7/26/2013,"07/26/2013",9/18/2013,"09/18/2013"
"Drugs",65876,"Ongoing","Beacon Hill Medical Pharmacy, P.C.","Southfield","MI","US","Voluntary: Firm Initiated","Telephone","USA nationwide","D-993-2013","Class II","PUMICE/LIDOCAINE HCL 1.5%/1% INJ SUSP, all presentations, FOR INTRAVENO AND SQ USE ONLY, STERILE, RX ONLY, Compounded by Beacon Hill Medical Pharmacy PC, dba Rxtra Solutions, Southfield, MI","05202013@20",".",,"Lack of Assurance of Sterility; FDA inspectional findings resulted in concerns associated with quality control procedures that impacted sterility assurance",7/26/2013,"07/26/2013",9/18/2013,"09/18/2013"
"Drugs",65876,"Ongoing","Beacon Hill Medical Pharmacy, P.C.","Southfield","MI","US","Voluntary: Firm Initiated","Telephone","USA nationwide","D-990-2013","Class II","PROCAINE P/F 20 MG/ML INJECTABLE, all presentations, FOR INTRAVENO AND SQ USE ONLY, STERILE, RX ONLY, Compounded by Beacon Hill Medical Pharmacy PC, dba Rxtra Solutions, Southfield, MI","06132013@30, 06272013@27 ",".",,"Lack of Assurance of Sterility; FDA inspectional findings resulted in concerns associated with quality control procedures that impacted sterility assurance",7/26/2013,"07/26/2013",9/18/2013,"09/18/2013"
"Drugs",65876,"Ongoing","Beacon Hill Medical Pharmacy, P.C.","Southfield","MI","US","Voluntary: Firm Initiated","Telephone","USA nationwide","D-987-2013","Class II","PARABEN WATER FOR INJECTION, all presentations, FOR INTRAVENO AND SQ USE ONLY, STERILE, RX ONLY, Compounded by Beacon Hill Medical Pharmacy PC, dba Rxtra Solutions, Southfield, MI","04012013@21, 07252013@15 ",".",,"Lack of Assurance of Sterility; FDA inspectional findings resulted in concerns associated with quality control procedures that impacted sterility assurance",7/26/2013,"07/26/2013",9/18/2013,"09/18/2013"
"Drugs",65876,"Ongoing","Beacon Hill Medical Pharmacy, P.C.","Southfield","MI","US","Voluntary: Firm Initiated","Telephone","USA nationwide","D-976-2013","Class II","MAGNESIUM CHLORIDE HEXAHYDRATE 20% INJECTABLE, all presentations, FOR INTRAVENO and SQ USE ONLY, STERILE, RX ONLY, Compounded by Beacon Hill Medical Pharmacy PC, dba Rxtra Solutions, Southfield, MI","01212013@10, 03042013@26, 04032013@23, 04222013@26, 06052013@12, 06122013@27, 07032013@7, 07092013@21, 07152013@40, 07262013@21 ",".",,"Lack of Assurance of Sterility; FDA inspectional findings resulted in concerns associated with quality control procedures that impacted sterility assurance",7/26/2013,"07/26/2013",9/18/2013,"09/18/2013"
"Drugs",65876,"Ongoing","Beacon Hill Medical Pharmacy, P.C.","Southfield","MI","US","Voluntary: Firm Initiated","Telephone","USA nationwide","D-999-2013","Class II","SODIUM HYDROXIDE 10% (W/V)/WATER FOR INJECTION, all presentations, FOR INTRAVENO AND SQ USE ONLY, STERILE, RX ONLY, Compounded by Beacon Hill Medical Pharmacy PC, dba Rxtra Solutions, Southfield, MI","04152013@28",".",,"Lack of Assurance of Sterility; FDA inspectional findings resulted in concerns associated with quality control procedures that impacted sterility assurance",7/26/2013,"07/26/2013",9/18/2013,"09/18/2013"
"Drugs",65876,"Ongoing","Beacon Hill Medical Pharmacy, P.C.","Southfield","MI","US","Voluntary: Firm Initiated","Telephone","USA nationwide","D-982-2013","Class II","MULTITRACE-5 INJECTABLE, all presentations, FOR INTRAVENO and SQ USE ONLY, STERILE, RX ONLY, Compounded by Beacon Hill Medical Pharmacy PC, dba Rxtra Solutions, Southfield, MI","02082013@10 and 07162013@10 ",".",,"Lack of Assurance of Sterility; FDA inspectional findings resulted in concerns associated with quality control procedures that impacted sterility assurance",7/26/2013,"07/26/2013",9/18/2013,"09/18/2013"
"Drugs",65876,"Ongoing","Beacon Hill Medical Pharmacy, P.C.","Southfield","MI","US","Voluntary: Firm Initiated","Telephone","USA nationwide","D-974-2013","Class II","LIPO-PLEX INJECTABLE, all presentations, FOR INTRAVENO and SQ USE ONLY, STERILE, RX ONLY, Compounded by Beacon Hill Medical Pharmacy PC, dba Rxtra Solutions, Southfield, MI","03192013@28, 02082013@20, 04042013@10 ",".",,"Lack of Assurance of Sterility; FDA inspectional findings resulted in concerns associated with quality control procedures that impacted sterility assurance",7/26/2013,"07/26/2013",9/18/2013,"09/18/2013"
"Drugs",65876,"Ongoing","Beacon Hill Medical Pharmacy, P.C.","Southfield","MI","US","Voluntary: Firm Initiated","Telephone","USA nationwide","D-1015-2013","Class II","BUPRENORPHINE 0.1/0.05 MG/ML CREAM, all configurations, FOR INTRAVENO AND SQ USE ONLY, STERILE, RX ONLY, Compounded by Beacon Hill Medical Pharmacy PC, dba Rxtra Solutions, Southfield, MI","04252013@12 and 07232013@25",".",,"Lack of Assurance of Sterility; FDA inspectional findings resulted in concerns associated with quality control procedures that impacted sterility assurance",7/26/2013,"07/26/2013",9/18/2013,"09/18/2013"
"Drugs",65876,"Ongoing","Beacon Hill Medical Pharmacy, P.C.","Southfield","MI","US","Voluntary: Firm Initiated","Telephone","USA nationwide","D-969-2013","Class II","HYDROXOCOBALAMIN (VITAMIN B12A) 1 MG/ML INJECTABLE, all presentations, FOR INTRAVENO and SQ USE ONLY, STERILE, RX ONLY, Compounded by Beacon Hill Medical Pharmacy PC, dba Rxtra Solutions, Southfield, MI","01042013@16, 02262013@21, 03072013@9, 03042013@23, 07022013@36 07252013@18 ",".",,"Lack of Assurance of Sterility; FDA inspectional findings resulted in concerns associated with quality control procedures that impacted sterility assurance",7/26/2013,"07/26/2013",9/18/2013,"09/18/2013"
"Drugs",65876,"Ongoing","Beacon Hill Medical Pharmacy, P.C.","Southfield","MI","US","Voluntary: Firm Initiated","Telephone","USA nationwide","D-1003-2013","Class II","TESTOSTERONE CYPIONATE 100 MG/ML, 200 MG/ML, 20 MG/ML OIL INJ SOLN, all configuration, FOR INTRAVENO AND SQ USE ONLY, STERILE, RX ONLY, Compounded by Beacon Hill Medical Pharmacy PC, dba Rxtra Solutions, Southfield, MI","07222013@15, 04192013@5, 06272013@26, 07012013@5 ",".",,"Lack of Assurance of Sterility; FDA inspectional findings resulted in concerns associated with quality control procedures that impacted sterility assurance",7/26/2013,"07/26/2013",9/18/2013,"09/18/2013"
"Drugs",65876,"Ongoing","Beacon Hill Medical Pharmacy, P.C.","Southfield","MI","US","Voluntary: Firm Initiated","Telephone","USA nationwide","D-954-2013","Class II","ESTRADIOL CYP/PROG/TEST CYP 0.5/10/10 MG/ML OIL INJ SOLN, all presentations, FOR INTRAVENO AND SQ USE ONLY, STERILE, RX ONLY, Compounded by Beacon Hill Medical Pharmacy PC, dba Rxtra Solutions, Southfield, MI","05012013@25, 06202013@6 ",".",,"Lack of Assurance of Sterility; FDA inspectional findings resulted in concerns associated with quality control procedures that impacted sterility assurance",7/26/2013,"07/26/2013",9/18/2013,"09/18/2013"
"Drugs",65876,"Ongoing","Beacon Hill Medical Pharmacy, P.C.","Southfield","MI","US","Voluntary: Firm Initiated","Telephone","USA nationwide","D-1010-2013","Class II","VITAMIN D 50,000 I.U./ML INJECTABLE, all configurations, FOR INTRAVENO AND SQ USE ONLY, STERILE, RX ONLY, Compounded by Beacon Hill Medical Pharmacy PC, dba Rxtra Solutions, Southfield, MI","03082013@20, 07032013@15 ",".",,"Lack of Assurance of Sterility; FDA inspectional findings resulted in concerns associated with quality control procedures that impacted sterility assurance",7/26/2013,"07/26/2013",9/18/2013,"09/18/2013"
"Drugs",65876,"Ongoing","Beacon Hill Medical Pharmacy, P.C.","Southfield","MI","US","Voluntary: Firm Initiated","Telephone","USA nationwide","D-953-2013","Class II","EDETATE DISODIUM 150 MG/ML INJECTABLE, all presentations, FOR INTRAVENO AND SQ USE ONLY, STERILE, RX ONLY, Compounded by Beacon Hill Medical Pharmacy PC, dba Rxtra Solutions, Southfield, MI","07172013@4, 01222013@14, 03072013@10, 04032013@1, 05162013@17, 06042013@30m, 07092013@17, and 07262013@2 ",".",,"Lack of Assurance of Sterility; FDA inspectional findings resulted in concerns associated with quality control procedures that impacted sterility assurance",7/26/2013,"07/26/2013",9/18/2013,"09/18/2013"
"Drugs",65876,"Ongoing","Beacon Hill Medical Pharmacy, P.C.","Southfield","MI","US","Voluntary: Firm Initiated","Telephone","USA nationwide","D-949-2013","Class II","DEXTROSE PF 50% INJECTABLE, all presentations, FOR INTRAVENO AND SQ USE ONLY, STERILE, RX ONLY, Compounded by Beacon Hill Medical Pharmacy PC, dba Rxtra Solutions, Southfield, MI","05202013@11, 07092013@19 ",".",,"Lack of Assurance of Sterility; FDA inspectional findings resulted in concerns associated with quality control procedures that impacted sterility assurance",7/26/2013,"07/26/2013",9/18/2013,"09/18/2013"
"Drugs",65876,"Ongoing","Beacon Hill Medical Pharmacy, P.C.","Southfield","MI","US","Voluntary: Firm Initiated","Telephone","USA nationwide","D-943-2013","Class II","CALCIUM CHLORIDE 100 MG/ML INJECTABLE, all presentations, FOR INTRAVENO AND SQ USE ONLY, STERILE, RX ONLY, Compounded by Beacon Hill Medical Pharmacy PC, dba Rxtra Solutions, Southfield, MI","02042013@22, 04102013@23, 05072013@18, 05312013@23, 07242013@3 ",".",,"Lack of Assurance of Sterility; FDA inspectional findings resulted in concerns associated with quality control procedures that impacted sterility assurance",7/26/2013,"07/26/2013",9/18/2013,"09/18/2013"
"Drugs",65876,"Ongoing","Beacon Hill Medical Pharmacy, P.C.","Southfield","MI","US","Voluntary: Firm Initiated","Telephone","USA nationwide","D-945-2013","Class II","COPPER 0.4MG/ML INJECTABLE, all presentations, FOR INTRAVENO AND SQ USE ONLY, STERILE, RX ONLY, Compounded by Beacon Hill Medical Pharmacy PC, dba Rxtra Solutions, Southfield, MI"," 04042013@23",".",,"Lack of Assurance of Sterility; FDA inspectional findings resulted in concerns associated with quality control procedures that impacted sterility assurance",7/26/2013,"07/26/2013",9/18/2013,"09/18/2013"
"Drugs",65876,"Ongoing","Beacon Hill Medical Pharmacy, P.C.","Southfield","MI","US","Voluntary: Firm Initiated","Telephone","USA nationwide","D-967-2013","Class II","HYDROGEN PEROXIDE 3% INJECTABLE, all presentations, FOR INTRAVENO and SQ USE ONLY, STERILE, RX ONLY, Compounded by Beacon Hill Medical Pharmacy PC, dba Rxtra Solutions, Southfield, MI","03262013@26",".",,"Lack of Assurance of Sterility; FDA inspectional findings resulted in concerns associated with quality control procedures that impacted sterility assurance",7/26/2013,"07/26/2013",9/18/2013,"09/18/2013"
"Drugs",65876,"Ongoing","Beacon Hill Medical Pharmacy, P.C.","Southfield","MI","US","Voluntary: Firm Initiated","Telephone","USA nationwide","D-1013-2013","Class II","ASCORBIC ACID (CORN SOURCE) 500 MG/ML INJECTABLE, all configurations, FOR INTRAVENO AND SQ USE ONLY, STERILE, RX ONLY, Compounded by Beacon Hill Medical Pharmacy PC, dba Rxtra Solutions, Southfield, MI","02202013@9 and 04052013@2",".",,"Lack of Assurance of Sterility; FDA inspectional findings resulted in concerns associated with quality control procedures that impacted sterility assurance",7/26/2013,"07/26/2013",9/18/2013,"09/18/2013"
"Drugs",65876,"Ongoing","Beacon Hill Medical Pharmacy, P.C.","Southfield","MI","US","Voluntary: Firm Initiated","Telephone","USA nationwide","D-998-2013","Class II","SODIUM BICARBONATE PF 8.4% INJECTABLE, all presentations, FOR INTRAVENO AND SQ USE ONLY, STERILE, RX ONLY, Compounded by Beacon Hill Medical Pharmacy PC, dba Rxtra Solutions, Southfield, MI","03262013@5, 01212013@6, 01232013@5 ",".",,"Lack of Assurance of Sterility; FDA inspectional findings resulted in concerns associated with quality control procedures that impacted sterility assurance",7/26/2013,"07/26/2013",9/18/2013,"09/18/2013"
"Drugs",65876,"Ongoing","Beacon Hill Medical Pharmacy, P.C.","Southfield","MI","US","Voluntary: Firm Initiated","Telephone","USA nationwide","D-948-2013","Class II","DEXPANTHENOL 250 MG/ML INJECTABLE, all presentations, FOR INTRAVENO AND SQ USE ONLY, STERILE, RX ONLY, Compounded by Beacon Hill Medical Pharmacy PC, dba Rxtra Solutions, Southfield, MI","06262013@42",".",,"Lack of Assurance of Sterility; FDA inspectional findings resulted in concerns associated with quality control procedures that impacted sterility assurance",7/26/2013,"07/26/2013",9/18/2013,"09/18/2013"
"Drugs",65876,"Ongoing","Beacon Hill Medical Pharmacy, P.C.","Southfield","MI","US","Voluntary: Firm Initiated","Telephone","USA nationwide","D-968-2013","Class II","HYALURONIDASE 150 U/ML and 200 U/ML INJECTABLE, all presentations, FOR INTRAVENO and SQ USE ONLY, STERILE, RX ONLY, Compounded by Beacon Hill Medical Pharmacy PC, dba Rxtra Solutions, Southfield, MI","05312013@24, 04242013@34 ",".",,"Lack of Assurance of Sterility; FDA inspectional findings resulted in concerns associated with quality control procedures that impacted sterility assurance",7/26/2013,"07/26/2013",9/18/2013,"09/18/2013"
"Drugs",65876,"Ongoing","Beacon Hill Medical Pharmacy, P.C.","Southfield","MI","US","Voluntary: Firm Initiated","Telephone","USA nationwide","D-951-2013","Class II","DMPS 50mg/ml INJECTABLE, all presentations, FOR INTRAVENO AND SQ USE ONLY, STERILE, RX ONLY, Compounded by Beacon Hill Medical Pharmacy PC, dba Rxtra Solutions, Southfield, MI","03152013@19, 07012013@9 ",".",,"Lack of Assurance of Sterility; FDA inspectional findings resulted in concerns associated with quality control procedures that impacted sterility assurance",7/26/2013,"07/26/2013",9/18/2013,"09/18/2013"
"Drugs",65876,"Ongoing","Beacon Hill Medical Pharmacy, P.C.","Southfield","MI","US","Voluntary: Firm Initiated","Telephone","USA nationwide","D-981-2013","Class II","MIC-CARN MAX 15/100/50/1 MG/ML INJECTABLE, all presentations, FOR INTRAVENO and SQ USE ONLY, STERILE, RX ONLY, Compounded by Beacon Hill Medical Pharmacy PC, dba Rxtra Solutions, Southfield, MI","03192013@29, 01242013@28, 05212013@23, 06252013@1 and 07022013@27",".",,"Lack of Assurance of Sterility; FDA inspectional findings resulted in concerns associated with quality control procedures that impacted sterility assurance",7/26/2013,"07/26/2013",9/18/2013,"09/18/2013"
"Drugs",65876,"Ongoing","Beacon Hill Medical Pharmacy, P.C.","Southfield","MI","US","Voluntary: Firm Initiated","Telephone","USA nationwide","D-1017-2013","Class II","CALCIUM EDTA 300 MG/ML INJECTABLE, all configurations, FOR INTRAVENO AND SQ USE ONLY, STERILE, RX ONLY, Compounded by Beacon Hill Medical Pharmacy PC, dba Rxtra Solutions, Southfield, MI","01082013@7 and 05062013@29",".",,"Lack of Assurance of Sterility; FDA inspectional findings resulted in concerns associated with quality control procedures that impacted sterility assurance",7/26/2013,"07/26/2013",9/18/2013,"09/18/2013"
"Drugs",65876,"Ongoing","Beacon Hill Medical Pharmacy, P.C.","Southfield","MI","US","Voluntary: Firm Initiated","Telephone","USA nationwide","D-936-2013","Class II","B-COMPLEX/LIDO/B-12, 25MG/ML INJECTABLE, all presentations, FOR INTRAVENO AND SQ USE ONLY, STERILE, RX ONLY, Compounded by Beacon Hill Medical Pharmacy PC, dba Rxtra Solutions, Southfield, MI","03202013@33",".",,"Lack of Assurance of Sterility; FDA inspectional findings resulted in concerns associated with quality control procedures that impacted sterility assurance",7/26/2013,"07/26/2013",9/18/2013,"09/18/2013"
"Drugs",65876,"Ongoing","Beacon Hill Medical Pharmacy, P.C.","Southfield","MI","US","Voluntary: Firm Initiated","Telephone","USA nationwide","D-971-2013","Class II","KETOROLAC TROMETHAMINE 60 MG/ML INJECTABLE, all presentations, FOR INTRAVENO and SQ USE ONLY, STERILE, RX ONLY, Compounded by Beacon Hill Medical Pharmacy PC, dba Rxtra Solutions, Southfield, MI","03202013@25",".",,"Lack of Assurance of Sterility; FDA inspectional findings resulted in concerns associated with quality control procedures that impacted sterility assurance",7/26/2013,"07/26/2013",9/18/2013,"09/18/2013"
"Drugs",65876,"Ongoing","Beacon Hill Medical Pharmacy, P.C.","Southfield","MI","US","Voluntary: Firm Initiated","Telephone","USA nationwide","D-955-2013","Class II","ESTRADIOL CYPIONATE 5, 10, 40 MG/ML OIL INJ SOLN, all configuration, FOR INTRAVENO AND SQ USE ONLY, STERILE, RX ONLY, Compounded by Beacon Hill Medical Pharmacy PC, dba Rxtra Solutions, Southfield, MI","02072013@11, 04042013@14, 01312013@3, 01072013@8 ",".",,"Lack of Assurance of Sterility; FDA inspectional findings resulted in concerns associated with quality control procedures that impacted sterility assurance",7/26/2013,"07/26/2013",9/18/2013,"09/18/2013"
"Drugs",65876,"Ongoing","Beacon Hill Medical Pharmacy, P.C.","Southfield","MI","US","Voluntary: Firm Initiated","Telephone","USA nationwide","D-1000-2013","Class II","SODIUM PHOSPHATE DIBASIC/WATER FOR INJECTION 10%, all presentations, FOR INTRAVENO AND SQ USE ONLY, STERILE, RX ONLY, Compounded by Beacon Hill Medical Pharmacy PC, dba Rxtra Solutions, Southfield, MI","01242013@11",".",,"Lack of Assurance of Sterility; FDA inspectional findings resulted in concerns associated with quality control procedures that impacted sterility assurance",7/26/2013,"07/26/2013",9/18/2013,"09/18/2013"
"Drugs",65876,"Ongoing","Beacon Hill Medical Pharmacy, P.C.","Southfield","MI","US","Voluntary: Firm Initiated","Telephone","USA nationwide","D-938-2013","Class II","ARGININE (R-GENE) 100 MG/ML INJECTABLE, all presentations, FOR INTRAVENO AND SQ USE ONLY, STERILE, RX ONLY, Compounded by Beacon Hill Medical Pharmacy PC, dba Rxtra Solutions, Southfield, MI ","03262013@3, 04302013@21, 06132013@1, 07102013@22 ",".",,"Lack of Assurance of Sterility; FDA inspectional findings resulted in concerns associated with quality control procedures that impacted sterility assurance",7/26/2013,"07/26/2013",9/18/2013,"09/18/2013"
"Drugs",65876,"Ongoing","Beacon Hill Medical Pharmacy, P.C.","Southfield","MI","US","Voluntary: Firm Initiated","Telephone","USA nationwide","D-984-2013","Class II","NALTREXONE 1 MG/ML INJECTABLE and 200 MG/ML INJECTABLE, all presentations, FOR INTRAVENO AND SQ USE ONLY, STERILE, RX ONLY, Compounded by Beacon Hill Medical Pharmacy PC, dba Rxtra Solutions, Southfield, MI","07262013@14 and 07262013@12 ",".",,"Lack of Assurance of Sterility; FDA inspectional findings resulted in concerns associated with quality control procedures that impacted sterility assurance",7/26/2013,"07/26/2013",9/18/2013,"09/18/2013"
"Drugs",65876,"Ongoing","Beacon Hill Medical Pharmacy, P.C.","Southfield","MI","US","Voluntary: Firm Initiated","Telephone","USA nationwide","D-935-2013","Class II","B-12/LIDOCAINE 25/10MG/ML, all presentations, FOR INTRAVENO AND SQ USE ONLY, STERILE, RX ONLY, Compounded by Beacon Hill Medical Pharmacy PC, dba Rxtra Solutions, Southfield, MI ","01092013@13",".",,"Lack of Assurance of Sterility; FDA inspectional findings resulted in concerns associated with quality control procedures that impacted sterility assurance",7/26/2013,"07/26/2013",9/18/2013,"09/18/2013"
"Drugs",65876,"Ongoing","Beacon Hill Medical Pharmacy, P.C.","Southfield","MI","US","Voluntary: Firm Initiated","Telephone","USA nationwide","D-1014-2013","Class II","B-12 REJUV 25 MG/ML INJECTABLE, all configurations, FOR INTRAVENO AND SQ USE ONLY, STERILE, RX ONLY, Compounded by Beacon Hill Medical Pharmacy PC, dba Rxtra Solutions, Southfield, MI","01112013@18, 02112013@8, 03052013@11, 04032013@19, 04122013@34, 05132013@18, 06052013@37, 06212013@14 and 06292013@7",".",,"Lack of Assurance of Sterility; FDA inspectional findings resulted in concerns associated with quality control procedures that impacted sterility assurance",7/26/2013,"07/26/2013",9/18/2013,"09/18/2013"
"Drugs",65876,"Ongoing","Beacon Hill Medical Pharmacy, P.C.","Southfield","MI","US","Voluntary: Firm Initiated","Telephone","USA nationwide","D-1012-2013","Class II","ALPROSTADIL 100 MCG/ML INJ SOLN, all sizes, FOR INTRAVENO AND SQ USE ONLY, STERILE, RX ONLY, Compounded by Beacon Hill Medical Pharmacy PC, dba Rxtra Solutions, Southfield, MI","06262013@33",".",,"Lack of Assurance of Sterility; FDA inspectional findings resulted in concerns associated with quality control procedures that impacted sterility assurance",7/26/2013,"07/26/2013",9/18/2013,"09/18/2013"
"Drugs",65876,"Ongoing","Beacon Hill Medical Pharmacy, P.C.","Southfield","MI","US","Voluntary: Firm Initiated","Telephone","USA nationwide","D-958-2013","Class II","FREAMINE III ALT. 8.5% INJECTABLE, all presentations, FOR INTRAVENO AND SQ USE ONLY, STERILE, RX ONLY, Compounded by Beacon Hill Medical Pharmacy PC, dba Rxtra Solutions, Southfield, MI","03262013@11, 01212013@12, 02112013@17, 02262013@7, 03012013@17, 04102013@8, 04112013@7, 04292013@20, 05212013@4, 06042013@12, 06202013@3, 07152013@19, 07242013@14, ",".",,"Lack of Assurance of Sterility; FDA inspectional findings resulted in concerns associated with quality control procedures that impacted sterility assurance",7/26/2013,"07/26/2013",9/18/2013,"09/18/2013"
"Drugs",65876,"Ongoing","Beacon Hill Medical Pharmacy, P.C.","Southfield","MI","US","Voluntary: Firm Initiated","Telephone","USA nationwide","D-986-2013","Class II","OXYTOCIN 10 UNITS/ML, all presentations, FOR INTRAVENO AND SQ USE ONLY, STERILE, RX ONLY, Compounded by Beacon Hill Medical Pharmacy PC, dba Rxtra Solutions, Southfield, MI","03212013@12, 01112013@20, 03072013@19, and 05082013@27",".",,"Lack of Assurance of Sterility; FDA inspectional findings resulted in concerns associated with quality control procedures that impacted sterility assurance",7/26/2013,"07/26/2013",9/18/2013,"09/18/2013"
"Drugs",65876,"Ongoing","Beacon Hill Medical Pharmacy, P.C.","Southfield","MI","US","Voluntary: Firm Initiated","Telephone","USA nationwide","D-980-2013","Class II","MIC-CARN + B6/B12/LIDOCAINE 25/50/50/175MCG/1/0.1MG/ML INJECTABLE, all presentations, FOR INTRAVENO and SQ USE ONLY, STERILE, RX ONLY, Compounded by Beacon Hill Medical Pharmacy PC, dba Rxtra Solutions, Southfield, MI","02142013@6, 05022013@15, 07192013@13 ",".",,"Lack of Assurance of Sterility; FDA inspectional findings resulted in concerns associated with quality control procedures that impacted sterility assurance",7/26/2013,"07/26/2013",9/18/2013,"09/18/2013"
"Drugs",65876,"Ongoing","Beacon Hill Medical Pharmacy, P.C.","Southfield","MI","US","Voluntary: Firm Initiated","Telephone","USA nationwide","D-1007-2013","Class II","TRIPLE-TESTOSTERONE 250 MG/ML OIL INJ SOLN and TRIPLE-TESTOSTERONE 200 MG/ML OIL INJ SOLN, all configurations, FOR INTRAVENO AND SQ USE ONLY, STERILE, RX ONLY, Compounded by Beacon Hill Medical Pharmacy PC, dba Rxtra Solutions, Southfield, MI","07182013@1, 03202013@19, 01022013@31, 01292013@2, 04182013@10, 06142013@1, 07122013@1, 07132013@9 ",".",,"Lack of Assurance of Sterility; FDA inspectional findings resulted in concerns associated with quality control procedures that impacted sterility assurance",7/26/2013,"07/26/2013",9/18/2013,"09/18/2013"
"Drugs",65876,"Ongoing","Beacon Hill Medical Pharmacy, P.C.","Southfield","MI","US","Voluntary: Firm Initiated","Telephone","USA nationwide","D-1004-2013","Class II","TESTOSTERONE PROPIONATE 100 MG/ML OIL INJ SOLN, all configuration, FOR INTRAVENO AND SQ USE ONLY, STERILE, RX ONLY, Compounded by Beacon Hill Medical Pharmacy PC, dba Rxtra Solutions, Southfield, MI","04172013@15, 06042013@17 ",".",,"Lack of Assurance of Sterility; FDA inspectional findings resulted in concerns associated with quality control procedures that impacted sterility assurance",7/26/2013,"07/26/2013",9/18/2013,"09/18/2013"
"Drugs",65876,"Ongoing","Beacon Hill Medical Pharmacy, P.C.","Southfield","MI","US","Voluntary: Firm Initiated","Telephone","USA nationwide","D-961-2013","Class II","GLUTATHIONE 200 MG/ML (PF) INJ SOLN, all presentations, FOR INTRAVENO and SQ USE ONLY, STERILE, RX ONLY, Compounded by Beacon Hill Medical Pharmacy PC, dba Rxtra Solutions, Southfield, MI","03192013@30, 02202013@6, 04042013@2, 04302013@20, 04252013@19 06202013@35, 06212013@17 ",".",,"Lack of Assurance of Sterility; FDA inspectional findings resulted in concerns associated with quality control procedures that impacted sterility assurance",7/26/2013,"07/26/2013",9/18/2013,"09/18/2013"
"Drugs",65876,"Ongoing","Beacon Hill Medical Pharmacy, P.C.","Southfield","MI","US","Voluntary: Firm Initiated","Telephone","USA nationwide","D-962-2013","Class II","GLUTATHIONE/LIDO 100MG/2%/ML (PF) INJ SOLN, all presentations, FOR INTRAVENO and SQ USE ONLY, STERILE, RX ONLY, Compounded by Beacon Hill Medical Pharmacy PC, dba Rxtra Solutions, Southfield, MI","03202013@28, 04022013@23, 04042013@3, 06172013@25 ",".",,"Lack of Assurance of Sterility; FDA inspectional findings resulted in concerns associated with quality control procedures that impacted sterility assurance",7/26/2013,"07/26/2013",9/18/2013,"09/18/2013"
"Drugs",65876,"Ongoing","Beacon Hill Medical Pharmacy, P.C.","Southfield","MI","US","Voluntary: Firm Initiated","Telephone","USA nationwide","D-960-2013","Class II","GLUTAMINE 100 MG/ML INJ SOLN, all presentations, FOR INTRAVENO and SQ USE ONLY, STERILE, RX ONLY, Compounded by Beacon Hill Medical Pharmacy PC, dba Rxtra Solutions, Southfield, MI","06262013@22",".",,"Lack of Assurance of Sterility; FDA inspectional findings resulted in concerns associated with quality control procedures that impacted sterility assurance",7/26/2013,"07/26/2013",9/18/2013,"09/18/2013"
"Drugs",65876,"Ongoing","Beacon Hill Medical Pharmacy, P.C.","Southfield","MI","US","Voluntary: Firm Initiated","Telephone","USA nationwide","D-988-2013","Class II","PHOSPHATIDYLCHOLINE 50 MG/ML INJECTABLE, all presentations, FOR INTRAVENO AND SQ USE ONLY, STERILE, RX ONLY, Compounded by Beacon Hill Medical Pharmacy PC, dba Rxtra Solutions, Southfield, MI","07082013@26 ",".",,"Lack of Assurance of Sterility; FDA inspectional findings resulted in concerns associated with quality control procedures that impacted sterility assurance",7/26/2013,"07/26/2013",9/18/2013,"09/18/2013"
"Drugs",65876,"Ongoing","Beacon Hill Medical Pharmacy, P.C.","Southfield","MI","US","Voluntary: Firm Initiated","Telephone","USA nationwide","D-944-2013","Class II","CHROMIUM 4 MCG/ML INJECTABLE, all presentations, FOR INTRAVENO AND SQ USE ONLY, STERILE, RX ONLY, Compounded by Beacon Hill Medical Pharmacy PC, dba Rxtra Solutions, Southfield, MI"," 01152013@5, 04242013@32 ",".",,"Lack of Assurance of Sterility; FDA inspectional findings resulted in concerns associated with quality control procedures that impacted sterility assurance",7/26/2013,"07/26/2013",9/18/2013,"09/18/2013"
"Drugs",65876,"Ongoing","Beacon Hill Medical Pharmacy, P.C.","Southfield","MI","US","Voluntary: Firm Initiated","Telephone","USA nationwide","D-946-2013","Class II","CYANOCOBALAMIN 1000 MCG/ML INJ SOLN, all presentations, FOR INTRAVENO AND SQ USE ONLY, STERILE, RX ONLY, Compounded by Beacon Hill Medical Pharmacy PC, dba Rxtra Solutions, Southfield, MI","01092013@12, 02132013@17, 03122013@21, 04122013@33, 05132013@17 05282013@26, 06052013@33, 06252013@4, 06272013@2, 07152013@41 ",".",,"Lack of Assurance of Sterility; FDA inspectional findings resulted in concerns associated with quality control procedures that impacted sterility assurance",7/26/2013,"07/26/2013",9/18/2013,"09/18/2013"
"Drugs",65876,"Ongoing","Beacon Hill Medical Pharmacy, P.C.","Southfield","MI","US","Voluntary: Firm Initiated","Telephone","USA nationwide","D-1011-2013","Class II","Zinc Sulfate 1 mg/ml INJECTABLE, all configurations, FOR INTRAVENO AND SQ USE ONLY, STERILE, RX ONLY, Compounded by Beacon Hill Medical Pharmacy PC, dba Rxtra Solutions, Southfield, MI","02082013@9, 06102013@16",".",,"Lack of Assurance of Sterility; FDA inspectional findings resulted in concerns associated with quality control procedures that impacted sterility assurance",7/26/2013,"07/26/2013",9/18/2013,"09/18/2013"
"Drugs",65876,"Ongoing","Beacon Hill Medical Pharmacy, P.C.","Southfield","MI","US","Voluntary: Firm Initiated","Telephone","USA nationwide","D-937-2013","Class II","ALPROSTADIL, 50 MCG/ML INJ SOLN, all presentations, FOR INTRAVENO AND SQ USE ONLY, STERILE, RX ONLY, Compounded by Beacon Hill Medical Pharmacy PC, dba Rxtra Solutions, Southfield, MI","07232013@28 ",".",,"Lack of Assurance of Sterility; FDA inspectional findings resulted in concerns associated with quality control procedures that impacted sterility assurance",7/26/2013,"07/26/2013",9/18/2013,"09/18/2013"
"Drugs",65876,"Ongoing","Beacon Hill Medical Pharmacy, P.C.","Southfield","MI","US","Voluntary: Firm Initiated","Telephone","USA nationwide","D-979-2013","Class II","METHYLPREDNISOLONE ACETATE 40 MG/ML and 80 MG/ML INJECTABLE, all presentations, FOR INTRAVENO and SQ USE ONLY, STERILE, RX ONLY, Compounded by Beacon Hill Medical Pharmacy PC, dba Rxtra Solutions, Southfield, MI","03192013@22, 03192013@24, 02132013@2 ",".",,"Lack of Assurance of Sterility; FDA inspectional findings resulted in concerns associated with quality control procedures that impacted sterility assurance",7/26/2013,"07/26/2013",9/18/2013,"09/18/2013"
"Drugs",65876,"Ongoing","Beacon Hill Medical Pharmacy, P.C.","Southfield","MI","US","Voluntary: Firm Initiated","Telephone","USA nationwide","D-992-2013","Class II","PROGESTERONE 50 MG/ML OIL INJ SOLN, all presentations, FOR INTRAVENO AND SQ USE ONLY, STERILE, RX ONLY, Compounded by Beacon Hill Medical Pharmacy PC, dba Rxtra Solutions, Southfield, MI","01072013@10, 02262013@5, 06272013@28 ",".",,"Lack of Assurance of Sterility; FDA inspectional findings resulted in concerns associated with quality control procedures that impacted sterility assurance",7/26/2013,"07/26/2013",9/18/2013,"09/18/2013"
"Drugs",65876,"Ongoing","Beacon Hill Medical Pharmacy, P.C.","Southfield","MI","US","Voluntary: Firm Initiated","Telephone","USA nationwide","D-970-2013","Class II","HYDROXYPROGESTERONE CAPROATE 250 MG/ML OIL INJ SOLN, all presentations, FOR INTRAVENO and SQ USE ONLY, STERILE, RX ONLY, Compounded by Beacon Hill Medical Pharmacy PC, dba Rxtra Solutions, Southfield, MI","05032013@4, 05222013@13",".",,"Lack of Assurance of Sterility; FDA inspectional findings resulted in concerns associated with quality control procedures that impacted sterility assurance",7/26/2013,"07/26/2013",9/18/2013,"09/18/2013"
"Drugs",65876,"Ongoing","Beacon Hill Medical Pharmacy, P.C.","Southfield","MI","US","Voluntary: Firm Initiated","Telephone","USA nationwide","D-977-2013","Class II","MAGNESIUM SULFATE 50% INJECTABLE, all presentations, FOR INTRAVENO and SQ USE ONLY, STERILE, RX ONLY, Compounded by Beacon Hill Medical Pharmacy PC, dba Rxtra Solutions, Southfield, MI","01082013@14, 02182013@5, and 06052013@29",".",,"Lack of Assurance of Sterility; FDA inspectional findings resulted in concerns associated with quality control procedures that impacted sterility assurance",7/26/2013,"07/26/2013",9/18/2013,"09/18/2013"
"Drugs",65876,"Ongoing","Beacon Hill Medical Pharmacy, P.C.","Southfield","MI","US","Voluntary: Firm Initiated","Telephone","USA nationwide","D-997-2013","Class II","SERMORELIN ACETATE 10 MG INJECTABLE, all presentations, FOR INTRAVENO AND SQ USE ONLY, STERILE, RX ONLY, Compounded by Beacon Hill Medical Pharmacy PC, dba Rxtra Solutions, Southfield, MI","03182013@6, 03282013@26,01142013@2, 01182013@2, 01172013@15, 02192013@3, 03062013@8, 04102013@3, 04262013@11, 05142013@35, 05212013@20, 5212013@17, 05242013@6, 06082013@3, 06072013@10, 06182013@27, 06292013@1, 07132013@2, 07232013@3, 03182013@14 ",".",,"Lack of Assurance of Sterility; FDA inspectional findings resulted in concerns associated with quality control procedures that impacted sterility assurance",7/26/2013,"07/26/2013",9/18/2013,"09/18/2013"
"Drugs",65876,"Ongoing","Beacon Hill Medical Pharmacy, P.C.","Southfield","MI","US","Voluntary: Firm Initiated","Telephone","USA nationwide","D-964-2013","Class II","GLYCINE 50 MG/ML INJECTABLE, all presentations, FOR INTRAVENO and SQ USE ONLY, STERILE, RX ONLY, Compounded by Beacon Hill Medical Pharmacy PC, dba Rxtra Solutions, Southfield, MI","03012013@16",".",,"Lack of Assurance of Sterility; FDA inspectional findings resulted in concerns associated with quality control procedures that impacted sterility assurance",7/26/2013,"07/26/2013",9/18/2013,"09/18/2013"
"Drugs",65876,"Ongoing","Beacon Hill Medical Pharmacy, P.C.","Southfield","MI","US","Voluntary: Firm Initiated","Telephone","USA nationwide","D-1008-2013","Class II","TRIPTROPIN PLUS INJECTABLE, all configurations, FOR INTRAVENO AND SQ USE ONLY, STERILE, RX ONLY, Compounded by Beacon Hill Medical Pharmacy PC, dba Rxtra Solutions, Southfield, MI","07022013@37, 01152013@32, 03012013@22, 03062013@15, 03122013@14, 04102013@4, 04242013@14, 04302013@2, 05242013@9, 06122013@26, 06122013@20, 07112013@16, 07232013@2 ",".",,"Lack of Assurance of Sterility; FDA inspectional findings resulted in concerns associated with quality control procedures that impacted sterility assurance",7/26/2013,"07/26/2013",9/18/2013,"09/18/2013"
"Drugs",65876,"Ongoing","Beacon Hill Medical Pharmacy, P.C.","Southfield","MI","US","Voluntary: Firm Initiated","Telephone","USA nationwide","D-956-2013","Class II","ESTRADIOL VALERATE W/ LIDOCAINE 1% 40 MG/ML OIL INJ SOLN, all configurations, FOR INTRAVENO AND SQ USE ONLY, STERILE, RX ONLY, Compounded by Beacon Hill Medical Pharmacy PC, dba Rxtra Solutions, Southfield, MI ","05022013@21",".",,"Lack of Assurance of Sterility; FDA inspectional findings resulted in concerns associated with quality control procedures that impacted sterility assurance",7/26/2013,"07/26/2013",9/18/2013,"09/18/2013"
"Drugs",65876,"Ongoing","Beacon Hill Medical Pharmacy, P.C.","Southfield","MI","US","Voluntary: Firm Initiated","Telephone","USA nationwide","D-947-2013","Class II","DEXAMETHASONE SODIUM PHOSPHATE 10 MG/ML INJECTABLE, all presentations, FOR INTRAVENO AND SQ USE ONLY, STERILE, RX ONLY, Compounded by Beacon Hill Medical Pharmacy PC, dba Rxtra Solutions, Southfield, MI ","01162013@13, 05202013@23, 07112013@11 ",".",,"Lack of Assurance of Sterility; FDA inspectional findings resulted in concerns associated with quality control procedures that impacted sterility assurance",7/26/2013,"07/26/2013",9/18/2013,"09/18/2013"
"Drugs",65876,"Ongoing","Beacon Hill Medical Pharmacy, P.C.","Southfield","MI","US","Voluntary: Firm Initiated","Telephone","USA nationwide","D-965-2013","Class II","GLYCYRRHIZIC ACID 8 MG/ML INJECTABLE, all presentations, FOR INTRAVENO and SQ USE ONLY, STERILE, RX ONLY, Compounded by Beacon Hill Medical Pharmacy PC, dba Rxtra Solutions, Southfield, MI","03072013@18, 04152013@27, 04112013@12 ",".",,"Lack of Assurance of Sterility; FDA inspectional findings resulted in concerns associated with quality control procedures that impacted sterility assurance",7/26/2013,"07/26/2013",9/18/2013,"09/18/2013"
"Drugs",65876,"Ongoing","Beacon Hill Medical Pharmacy, P.C.","Southfield","MI","US","Voluntary: Firm Initiated","Telephone","USA nationwide","D-1018-2013","Class II","MANGANESE SULFATE 0.1 MG/ML INJECTABLE, all configurations, FOR INTRAVENO AND SQ USE ONLY, STERILE, RX ONLY, Compounded by Beacon Hill Medical Pharmacy PC, dba Rxtra Solutions, Southfield, MI","01212013@8, 04042013@15 and 06272013@29",".",,"Lack of Assurance of Sterility; FDA inspectional findings resulted in concerns associated with quality control procedures that impacted sterility assurance",7/26/2013,"07/26/2013",9/18/2013,"09/18/2013"
"Drugs",65876,"Ongoing","Beacon Hill Medical Pharmacy, P.C.","Southfield","MI","US","Voluntary: Firm Initiated","Telephone","USA nationwide","D-934-2013","Class II","ASCORBIC ACID ( non-CORN SOURCE) 500 MG/ML INJECTABLE, all presentations, FOR INTRAVENO AND SQ USE ONLY, STERILE, RX ONLY, Compounded by Beacon Hill Medical Pharmacy PC, dba Rxtra Solutions, Southfield, MI ","02082013@12 06072013@22 06152013@1 07252013@13 ",".",,"Lack of Assurance of Sterility; FDA inspectional findings resulted in concerns associated with quality control procedures that impacted sterility assurance",7/26/2013,"07/26/2013",9/18/2013,"09/18/2013"
"Drugs",65876,"Ongoing","Beacon Hill Medical Pharmacy, P.C.","Southfield","MI","US","Voluntary: Firm Initiated","Telephone","USA nationwide","D-939-2013","Class II","B-COMPLEX/LIDOCAINE 2% INJECTION, all presentations, FOR INTRAVENO AND SQ USE ONLY, STERILE, RX ONLY, Compounded by Beacon Hill Medical Pharmacy PC, dba Rxtra Solutions, Southfield, MI","04222013@23",".",,"Lack of Assurance of Sterility; FDA inspectional findings resulted in concerns associated with quality control procedures that impacted sterility assurance",7/26/2013,"07/26/2013",9/18/2013,"09/18/2013"
"Drugs",65876,"Ongoing","Beacon Hill Medical Pharmacy, P.C.","Southfield","MI","US","Voluntary: Firm Initiated","Telephone","USA nationwide","D-952-2013","Class II","DUAL-TESTOSTERONE 20, 50, 100, 150, 200 MG/ML OIL INJ SOLN, all presentations, FOR INTRAVENO AND SQ USE ONLY, STERILE, RX ONLY, Compounded by Beacon Hill Medical Pharmacy PC, dba Rxtra Solutions, Southfield, MI","05302013@6, 02112013@5, 04192013@21, 05032013@14, 01252013@11, 03272013@17, 01252013@8, 03272013@22, 01312013@9, 06062013@24, 01032013@1, 01152013@14, 01292013@4, 01312013@10, 02142013@9, 03062013@10, 03112013@6, 03112013@4, 04042013@16, 04122013@18, 04302013@24, 05102013@18, 05282013@29, 06042013@18, 06282013@10, 07112013@21, 07232013@1, 07282013@1, 07282013@2, 01312013@8, 05222013@26.",".",,"Lack of Assurance of Sterility; FDA inspectional findings resulted in concerns associated with quality control procedures that impacted sterility assurance",7/26/2013,"07/26/2013",9/18/2013,"09/18/2013"
"Drugs",65876,"Ongoing","Beacon Hill Medical Pharmacy, P.C.","Southfield","MI","US","Voluntary: Firm Initiated","Telephone","USA nationwide","D-985-2013","Class II","NANDROLONE DECANOATE 100 MG/ML and 200 MG/ML OIL INJ SOLN, all presentations, FOR INTRAVENO AND SQ USE ONLY, STERILE, RX ONLY, Compounded by Beacon Hill Medical Pharmacy PC, dba Rxtra Solutions, Southfield, MI","03272013@20, 02272013@17, 03262013@21, 03302013@1, 01152013@12, 02182013@10, 03112013@13, 05062013@13, 05242013@13, 05242013@12, 07012013@32 ",".",,"Lack of Assurance of Sterility; FDA inspectional findings resulted in concerns associated with quality control procedures that impacted sterility assurance",7/26/2013,"07/26/2013",9/18/2013,"09/18/2013"
"Drugs",65876,"Ongoing","Beacon Hill Medical Pharmacy, P.C.","Southfield","MI","US","Voluntary: Firm Initiated","Telephone","USA nationwide","D-1002-2013","Class II","TESTOSTERONE HYPOALLERGENIC 200 MG/ML INJECTABLE and TESTOSTERONE AQUEOUS 100 MG/ML INJECTABLE, all presentations, FOR INTRAVENO AND SQ USE ONLY, STERILE, RX ONLY, Compounded by Beacon Hill Medical Pharmacy PC, dba Rxtra Solutions, Southfield, MI","03112013@9, 05242013@17, 05312013@7, 06052013@21 ",".",,"Lack of Assurance of Sterility; FDA inspectional findings resulted in concerns associated with quality control procedures that impacted sterility assurance",7/26/2013,"07/26/2013",9/18/2013,"09/18/2013"
"Drugs",65876,"Ongoing","Beacon Hill Medical Pharmacy, P.C.","Southfield","MI","US","Voluntary: Firm Initiated","Telephone","USA nationwide","D-941-2013","Class II","BI-MIX PHENTOLAMINE/PAPAVERINE 0.5 MG/30 MG/ML and BI-MIX PHENTOLAMINE/PAPAVERINE 1 MG/30 MG/ML INJECTABLE, all presentations, FOR INTRAVENO AND SQ USE ONLY, STERILE, RX ONLY, Compounded by Beacon Hill Medical Pharmacy PC, dba Rxtra Solutions, Southfield, MI","07232013@23 and 04232013@27",".",,"Lack of Assurance of Sterility; FDA inspectional findings resulted in concerns associated with quality control procedures that impacted sterility assurance",7/26/2013,"07/26/2013",9/18/2013,"09/18/2013"
"Drugs",65876,"Ongoing","Beacon Hill Medical Pharmacy, P.C.","Southfield","MI","US","Voluntary: Firm Initiated","Telephone","USA nationwide","D-975-2013","Class II","LIPOIC ACID 100 MG/ML and 200 MG/ML INJECTABLE, all presentations, FOR INTRAVENO and SQ USE ONLY, STERILE, RX ONLY, Compounded by Beacon Hill Medical Pharmacy PC, dba Rxtra Solutions, Southfield, MI","06272013@25, 04152013@26, 06262013@19 ",".",,"Lack of Assurance of Sterility; FDA inspectional findings resulted in concerns associated with quality control procedures that impacted sterility assurance",7/26/2013,"07/26/2013",9/18/2013,"09/18/2013"
"Drugs",65877,"Ongoing","Sandoz Incorporated","Broomfield","CO","US","Voluntary: Firm Initiated","Letter","Nationwide","D-854-2013","Class III","Introvale (levonorgestrel and ethinyl estradiol) tablets, USP, 0.15 mg/0.03 mg, packaged in 91 day regimen per unit carton, 3 Unit Cartons x 91 tablets per box, Rx only, Manufactured by Laboratorios Leon Farma S.A., Spain for Sandoz Inc., Princeton, NJ 08540, NDC 0781-5584-36","Lots: LF01643C, LF01644C, Exp 7/14",".","8, 681 unit cartons","Contraceptive tablets out of sequence: Contraceptive tablets out of sequence: Introvale (levonorgestrel and ethinyl estradiol tablets USP 0.15mg/0.03mg) is voluntarily being recalled due to inactive placebo tablets incorrectly placed in Week 9, and active tablets placed in Week 13 on the blister card",8/7/2013,"08/07/2013",8/14/2013,"08/14/2013"
"Drugs",65878,"Ongoing","Bracco Diagnostics Inc","Monroe Township","NJ","US","Voluntary: Firm Initiated","Letter","Nationwide","D-885-2013","Class II","Gastrografin (Diatrizoate Meglumine and Diatrizoate Sodium Solution), USP, 37% Organically Bound Iodine, 120 ml bottle, Rx only, Manufactured for Bracco Diagnostics Inc. Princeton, NJ 08543 by Therapex, Division of E-Z-EM Canada Inc. Anjou Quebec H1J2Z4, Canada, NDC 0270-0445-40","Lot # 00500512, Exp. 11/15",,"29,436 bottles","Presence of foreign substance: One lot of the product may contain black foreign particles ",6/21/2013,"06/21/2013",8/21/2013,"08/21/2013"
"Devices",65879,"Ongoing","Convatec Inc.","Skillman","NJ","US","Voluntary: Firm Initiated","Letter","US Nationwide Distribution","Z-1990-2013","Class III","ConvaTec Flexi-Seal SIGNAL Fecal Management System, Rx Only Product Usage: For use to manage fecal incontinence through the collection of liquid to semi-liquid stool and to provide access to administer medication. ","Flexi-Seal Signal FMS Kit - ICC Code: 418000 SAP Code #1262167 Lot# 12-FM-01 and Lot# 12-FM-02. ",".","22,896 units","ConvaTec notified their customers on 6/25/2013 regarding the manufacturing irregularity that occurred related to the packaging of certain lots of Flexi-Seal Signal FMS. In certain lots, the lot number convention was duplicated on the packaging. ",6/25/2013,"06/25/2013",8/28/2013,"08/28/2013"
"Devices",65879,"Ongoing","Convatec Inc.","Skillman","NJ","US","Voluntary: Firm Initiated","Letter","US Nationwide Distribution","Z-1991-2013","Class III","ConvaTec Flexi-Seal SIGNAL +, Rx Only Product Usage: For use to manage fecal incontinence through the collection of liquid to semi-liquid stool and to provide access to administer medication. ","Flexi-Seal Signal + ICC Code 418000; SAP Code# 1705108, Lots 12-FM-01 and 12-FM-02. ",".","22,896 units","ConvaTec notified their customers on 6/25/2013 regarding the manufacturing irregularity that occurred related to the packaging of certain lots of Flexi-Seal Signal FMS. In certain lots, the lot number convention was duplicated on the packaging. ",6/25/2013,"06/25/2013",8/28/2013,"08/28/2013"
"Devices",65880,"Ongoing","GE Healthcare, LLC","Waukesha","WI","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution - USA Nationwide including Puerto Rico and the countries of: ANDORRA, AUSTRALIA, AUSTRIA, AZERBAIJAN, BRAZIL, BULGARIA, CANADA, CHILE, COLOMBIA, CZECH REPUBLIC, ESTONIA, FINLAND, GERMANY, HONG KONG, INDIA, INDONESIA, IRAQ, ITALY, JAPAN, KUWAIT, MALAYSIA, Norway, OMAN, PALESTINIAN TERRITORY, OCCUPIED, POLAND, PORTUGAL, RUSSIAN FEDERATION, SAUDI ARABIA, SINGAPORE, SLOVENIA, SOUTH AFRICA, SPAIN, SWEDEN, SWITZERLAND, TURKEY, and UNITED KINGDOM.","Z-2098-2013","Class II","GE Ultrasound ViewPoint 6. Product Usage: ViewPoint is intended to be used in medical practices and in clinical departments and serves the purposes of diagnostic interpretation of images, electronic documentation of examinations in the form of text and images and generation of medical reports primarily for diagnostic ultrasound. ViewPoint provides the user the ability to including images, drawings, and charts into medical reports. ViewPoint is designed to accept, transfer, display, calculate, store and process medical images and data, and enables the user to measure and annotate the images. The medical images, which ViewPoint displays to the user, can be used for diagnostic purposes. ViewPoint is intended for professional use only. ViewPoint is not intended to be used as an automated diagnosis system.","software versions 6.2, 6.2.1, 6.3, and 6.3.1",,"225","GE has recently become aware of a potential safety issue due to the incorrect calculation of the pulsatility index value (PIV) for venous flow measurements associated with obstetric reporting of the GE ViewPoint 6 system. The ViewPoint calculated Doppler PIV for veins could be incorrect. An incorrect calculation of the ductus venosus PIV could lead to false high risk for trisomy 13, 18, and 21, which potentially results in an inaccurate consultation of the patient.",8/7/2013,"08/07/2013",9/4/2013,"09/04/2013"
"Drugs",65881,"Ongoing","Actavis Inc","Parsippany","NJ","US","Voluntary: Firm Initiated","Letter","Nationwide and Puerto Rico","D-855-2013","Class III","BuPROPion Hydrochloride Extended-Release Tablets (XL), 300 mg, 30-count tablets per bottle, Rx only, Distributed by: Actavis South Atlantic, LLC, Sunrise, FL 33325; Packaged by: American Health Packaging, Columbus, OH 43217, NDC 67767-142-30, UPC 3 67767-142-30 6.","Lot #: CG2D18A, Exp 06/14",".","15,132 bottles","Failed Dissolution Specifications: Dissolution test results at 8 hour time-point were above approved specification limits.",7/31/2013,"07/31/2013",8/14/2013,"08/14/2013"
"Drugs",65882,"Ongoing","Apotex Inc","Richmond Hill",,"CA","Voluntary: Firm Initiated","Letter","Nationwide","D-852-2013","Class II","Latanoprost Ophthalmic Solution, 0.005% (125 mcg/2.5 mL), 2.5 mL bottle, Rx only, Manufactured by: Apotex Inc., Toronto, Ontario Canada M9L 1T9; Manufactured for: Apotex Corp., Weston, FL 33326; NDC 60505-0565-1; UPC 3 60505 05651 4.","Lot #: JX1877, Exp 06/13",".","50,982 bottles","Lack of Assurance of Sterility: Failed at expiry for Preservative Effectiveness Test (PET), therefore the product may be susceptible to microbial growth before the expiry date.",6/25/2013,"06/25/2013",8/14/2013,"08/14/2013"
"Devices",65883,"Ongoing","Microgenics Corp","Fremont","CA","US","Voluntary: Firm Initiated","Letter","US Distribution including the states of DC, MA, NJ, TX. FL, CA, WA, NY, TX, CT, KY, LA, AR, TN, AL, GA, CT, VA, NC, KS, MD, OH and IL","Z-2267-2013","Class II","DRI Cocaine Metabolite Assay, labeled as Multigent Cocaine Assay for Abbott Laboratories. 100 ml, IVD Mfg by: Microgenics Corporation, 46360 Fremont Blvd. Fremont, CA 94538 The DRI Cocaine Metabolite Enzyme Immunoassay is a homogeneous enzyme intended for the qualitative and semi-quantitative determination of benzoylecgonine (Cocaine Metabolite) in human urine with either 300 ng/mL or 150 ng/mL as a cutoff calibrator. The assay provided only a preliminary analytical test result. A more specific alternative chemical method must be used to obtain a confirm analytical result.","Part no. 0055, lot number 60053405, Exp 2/29/2016; Part No. 0056, lot number 60053396, Exp 2/29/2016; Part No. 10014593, lot number 60112588, Exp 2/29/2016; - not distributed Part number #l40-20, lot number 24215M500, Exp 8/13/14.",".","1473 units in distribution.","Surveillance of reagent stability for specific lots of DRI Cocaine Metabolite Reagent show an unexpected decreasing change in the reaction rate, indicating a faster than expected reagent degradation.",7/23/2013,"07/23/2013",10/2/2013,"10/02/2013"
"Veterinary",65884,"Ongoing","Beacon Hill Medical Pharmacy, P.C.","Southfield","MI","US","Voluntary: Firm Initiated","Telephone","Nationwide","V-317-2013","Class II","Meloxicam 10 MG/ML INJECTABLE Sterile Rx Only","Lot #'s: 07112013@10 (Date Made 7/11/2013) 01172013@5 (Date Made 1/17/2013) 03012013@20 (Date Made 3/1/2013) 03142013@8 (Date Made 3/14/2013) ",,"617 mls both concentrations","Lack of sterility assurance of sterile injectables. ",7/26/2013,"07/26/2013",10/9/2013,"10/09/2013"
"Veterinary",65884,"Ongoing","Beacon Hill Medical Pharmacy, P.C.","Southfield","MI","US","Voluntary: Firm Initiated","Telephone","Nationwide","V-318-2013","Class II","Tacrolimus Solution 0.02% OPTHALMIC Sterile Rx Only","Lot #'s: 03192013@34 (Date Made 3/19/2013) 01282013@19 (Date Made 1/28/2013)",,"234 mls","Lack of sterility assurance of sterile injectables. ",7/26/2013,"07/26/2013",10/9/2013,"10/09/2013"
"Veterinary",65884,"Ongoing","Beacon Hill Medical Pharmacy, P.C.","Southfield","MI","US","Voluntary: Firm Initiated","Telephone","Nationwide","V-313-2013","Class II","Apomorphine HCL 3 MG/ML INJECTABLE Sterile Rx Only","Lot # 03142013@7 Date Made 3/14/2013",,"18.5 mls","Lack of sterility assurance of sterile injectables. ",7/26/2013,"07/26/2013",10/9/2013,"10/09/2013"
"Veterinary",65884,"Ongoing","Beacon Hill Medical Pharmacy, P.C.","Southfield","MI","US","Voluntary: Firm Initiated","Telephone","Nationwide","V-314-2013","Class II","Buprenorphine .3 MG/ML INJECTABLE Buprenorphine .5 MG/ML INJECTABLE Sterile Rx Only","Lot #''s: 01222013@4 (Date Made 1/22/2013), 02222013@2(Date Made 2/22/2013) , 03142013@3 (Date Made 3/14/2013), 04182013@12 (Date Made 4/18/2013), 05062013@15 (Date Made 5/6/2013) , 07082013@25 (Date Made 7/8/2013) , 01022013@12 ( Date Made 1/2/2013), 04022013@25 ( Date Made 4/2/2013), 07082013@23 (Date Made 7/8/2013)",,"1386 mls (all lots)","Lack of sterility assurance of sterile injectables. ",7/26/2013,"07/26/2013",10/9/2013,"10/09/2013"
"Veterinary",65884,"Ongoing","Beacon Hill Medical Pharmacy, P.C.","Southfield","MI","US","Voluntary: Firm Initiated","Telephone","Nationwide","V-316-2013","Class II","Diazepam 5MG/ML INJECTABLE Sterile Rx Only","Lot #'s: 01212013@13 (Date Made 1/21/2013) 05302013@8 (Date Made 5/30/2013)",,"360 mls all lots","Lack of sterility assurance of sterile injectables. ",7/26/2013,"07/26/2013",10/9/2013,"10/09/2013"
"Veterinary",65884,"Ongoing","Beacon Hill Medical Pharmacy, P.C.","Southfield","MI","US","Voluntary: Firm Initiated","Telephone","Nationwide","V-315-2013","Class II","Cyclosporine (A) 2% (PF) Aqueous Susp Sterile Rx Only","Lot #'': 06032013@6 (Date Made 6/3/2013) ",,"18 mls","Lack of sterility assurance of sterile injectables. ",7/26/2013,"07/26/2013",10/9/2013,"10/09/2013"
"Drugs",65885,"Ongoing","Dr. Reddy's Laboratories, Inc.","Bridgewater","NJ","US","Voluntary: Firm Initiated","Letter","Nationwide","D-884-2013","Class II","Ranitidine Hydrochloride Tablets, USP, 150 mg, OTC, a) Equate brand Maximum Strength Acid Reducer, 65 count bottle Dist. By: Wal-Mart Stores, Inc., Bentonville, AR 72710, NDC 49035-404-61 b)Equaline brand maximum strength heartburn relief, , DISTRIBUTED BY SUPERVALU INC., EDEN PRAIRIE, MN 55344, NDC 41163-404-61, c)Wal-Zan brand 150, MAXIMUM STRENGTH, 24 count bottlle, DISTRIBUTED BY: WALGREEN CO., 200 WILMOT RD., DEERFIELD, IL 63015, NDC 0363-0404-34","a)Lot: 5055822, exp. 03/13; 5056317, exp. 03/15; and 5056507, exp. 04/15 b)Lot: 7956571C, exp. 04/15 c)Lot: 7956572A, exp. 04/15 ",,,"Microbial Contamination of Non-Sterile Products: A lot of raw material used in the manufacture of Ranitidine was positive for Pseudomonas sp. ",8/2/2013,"08/02/2013",8/21/2013,"08/21/2013"
"Devices",65886,"Ongoing","Roche Diagnostics Operations, Inc.","Indianapolis","IN","US","Voluntary: Firm Initiated","Letter","Nationwide Distribution","Z-2109-2013","Class II","ACCU-CHECK FastClix Lancing Device. It is intended for use in conjunction with a blood glucose monitoring system.","Lot Number(s): GDA 048, GDA050, GDA 051, GDA 063",,"36,332","Internal Roche inspections have revealed that after the lancet is used for a finger stick, the needle may not fully retract back within the lancet drum or back into the cap. This allows the needle to protrude inside the cap or outside of the cap of the ACCU-CHEK FastClix lancing device.",8/19/2013,"08/19/2013",9/4/2013,"09/04/2013"
"Devices",65888,"Ongoing","Stryker Communications","Flower Mound","TX","US","Voluntary: Firm Initiated","Letter","Worldwide Distributio: US natiowide and to the country of Canada.","Z-1992-2013","Class II","Stryker Visum 300 Ceiling-mounted Exam Light.","Product sold under the following part numbers: 0682001410A, 0682001410B, 0682001410C, 0682001410D, 0682001410E, 0682001410F, 0682001410G, and 0682001410H and shipped prior to February 28, 2013.",".","1,375 units","Potential incomplete final weld on the drop tube flange.",7/25/2013,"07/25/2013",8/28/2013,"08/28/2013"
"Drugs",65889,"Ongoing","Core Pharma Llc","Middlesex","NJ","US","Voluntary: Firm Initiated","Letter","Nationwide","D-1062-2013","Class II","Pyridostigmine Bromide Tablets, USP Rx Only 100 Tablets, Manufactured and Distributed by: CorePharma, LLC Middlesex, NJ 08846 NDC 64720-128-10 NDC 64720-128-10","109497; Exp. 12/15",".","960 bottles","Failed Stability Specifications: Pyridostigmine Bromide tablets, is being recalled due to an out of specification test result during stablity testing.",7/2/2013,"07/02/2013",10/2/2013,"10/02/2013"
"Devices",65890,"Ongoing","Synthes USA HQ, Inc.","West Chester","PA","US","Voluntary: Firm Initiated","Letter","USA Nationwide Distribution in the states of FL, GA, NC, OH, KY, NJ, ID, IN, and MN.","Z-2087-2013","Class II","Synthes 2.4 VA-LCP 2 CLMN VLR DSTL Radius PL 7H HD/3H Shaft/Right Product Usage: Intended for fixation of complex intra-and extra-articular fractures and osteotomies of the distal radius and other small bones.","Part No. 02.111.730, with Lot No. 3614792",,"11","The possibility exists that 2.4 mm VA-LCP 2 column distal radius plates from a specific lot are etched with ''R'' for right plate when they should be etched with ''L'' for left plate. ",7/30/2013,"07/30/2013",9/4/2013,"09/04/2013"
"Devices",65891,"Ongoing","Stryker Howmedica Osteonics Corp.","Mahwah","NJ","US","Voluntary: Firm Initiated","Letter","USA Nationwide Distribution in the states of: FL. OH, TX, & VA","Z-2099-2013","Class II","Stryker 1) Asnis III Cannulated Screw REF 604640 4.0x40mm TL 13.5mm 2) Asnis III Cannulated Screw REF 604642S 4.0x42mm TL 14mm, sterile Product Usage: The Asnis III Cannulated Screw System is intended for fracture fixation of small and long bones and of the pelvis. The system is not intended for spinal use. ","Catalog # 604640, Lot Code R11428 21 units Catalog # 604642S, Lot Code R09071 1 unit ",,"23 units","Stryker received a report that the length of the cannulated screw asnis III, article # 604640 Lot R11482, was incorrect. ",7/8/2013,"07/08/2013",9/4/2013,"09/04/2013"
"Devices",65893,"Ongoing","Instrumentation Laboratory Co.","Bedford","MA","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution - USA including AL, AR, AZ, CA, CO, CT, DE, FL, GA, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI, and WV. Internationally to Canada, Argentina, Australia, Austria, Belarus, Belgium, Brazil, Brunei, Chile, China, Colombia, Costa Rica, Czech Republic, Denmark, Dubai, Finland, France, Germany, Great Britian, Greece, Guatemala, Hong Kong, Hungary, India, Ireland, Israel, Italy, Japan, Korea, Kuwait, Luthuania, Luxembourg, Malaysia, Mexico, Netherlands, New Zealand, Norway, Panama, Peru, Philippines, Poland, Portugal, Romania, Russia, Saudi Arabia, Serbia, Singapore, Slovakia, Slovenia, South Africa, Spain, Sweden, Switzerland, Taiwan, Thailand, Tunisia, Turkey, Uruguay, Venezuela, and Viet Nam.","Z-2246-2013","Class II","ACL TOP CTS; PN 0000280020 Bench top, fully automated, random access analyzer designed specifically for in vitro diagnostic clinical use in the hemostasis laboratory for coagulation and/or fibrinolysis testing in the assessment of thrombosis and/or hemostasis. The systems provide results for both direct hemostasis measurements and calculated parameters. ","Start SN and Date: 06020101, Feb 2006; End SN and Date: 10080662, Aug 2010",,"486","Potential carryover issue that can can cause shortened APTT clotting times on the instrument. ",7/19/2013,"07/19/2013",9/25/2013,"09/25/2013"
"Devices",65893,"Ongoing","Instrumentation Laboratory Co.","Bedford","MA","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution - USA including AL, AR, AZ, CA, CO, CT, DE, FL, GA, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI, and WV. Internationally to Canada, Argentina, Australia, Austria, Belarus, Belgium, Brazil, Brunei, Chile, China, Colombia, Costa Rica, Czech Republic, Denmark, Dubai, Finland, France, Germany, Great Britian, Greece, Guatemala, Hong Kong, Hungary, India, Ireland, Israel, Italy, Japan, Korea, Kuwait, Luthuania, Luxembourg, Malaysia, Mexico, Netherlands, New Zealand, Norway, Panama, Peru, Philippines, Poland, Portugal, Romania, Russia, Saudi Arabia, Serbia, Singapore, Slovakia, Slovenia, South Africa, Spain, Sweden, Switzerland, Taiwan, Thailand, Tunisia, Turkey, Uruguay, Venezuela, and Viet Nam.","Z-2244-2013","Class II","ACL TOP (Base); PN 0000280000 Bench top, fully automated, random access analyzer designed specifically for in vitro diagnostic clinical use in the hemostasis laboratory for coagulation and/or fibrinolysis testing in the assessment of thrombosis and/or hemostasis. The systems provide results for both direct hemostasis measurements and calculated parameters. ","Nov 2003 - Nov 2011, Serial Numbers 02110101 through 11111174",,"929","Potential carryover issue that can can cause shortened APTT clotting times on the instrument. ",7/19/2013,"07/19/2013",9/25/2013,"09/25/2013"
"Devices",65893,"Ongoing","Instrumentation Laboratory Co.","Bedford","MA","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution - USA including AL, AR, AZ, CA, CO, CT, DE, FL, GA, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI, and WV. Internationally to Canada, Argentina, Australia, Austria, Belarus, Belgium, Brazil, Brunei, Chile, China, Colombia, Costa Rica, Czech Republic, Denmark, Dubai, Finland, France, Germany, Great Britian, Greece, Guatemala, Hong Kong, Hungary, India, Ireland, Israel, Italy, Japan, Korea, Kuwait, Luthuania, Luxembourg, Malaysia, Mexico, Netherlands, New Zealand, Norway, Panama, Peru, Philippines, Poland, Portugal, Romania, Russia, Saudi Arabia, Serbia, Singapore, Slovakia, Slovenia, South Africa, Spain, Sweden, Switzerland, Taiwan, Thailand, Tunisia, Turkey, Uruguay, Venezuela, and Viet Nam.","Z-2250-2013","Class II","ACL TOP 500 CTS; PN 0000280040 Bench top, fully automated, random access analyzer designed specifically for in vitro diagnostic clinical use in the hemostasis laboratory for coagulation and/or fibrinolysis testing in the assessment of thrombosis and/or hemostasis. The systems provide results for both direct hemostasis measurements and calculated parameters. ","Start SN and Date: 08010100 Jan 2008 - 13072599 July 2013",,"2170","Potential carryover issue that can can cause shortened APTT clotting times on the instrument. ",7/19/2013,"07/19/2013",9/25/2013,"09/25/2013"
"Devices",65893,"Ongoing","Instrumentation Laboratory Co.","Bedford","MA","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution - USA including AL, AR, AZ, CA, CO, CT, DE, FL, GA, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI, and WV. Internationally to Canada, Argentina, Australia, Austria, Belarus, Belgium, Brazil, Brunei, Chile, China, Colombia, Costa Rica, Czech Republic, Denmark, Dubai, Finland, France, Germany, Great Britian, Greece, Guatemala, Hong Kong, Hungary, India, Ireland, Israel, Italy, Japan, Korea, Kuwait, Luthuania, Luxembourg, Malaysia, Mexico, Netherlands, New Zealand, Norway, Panama, Peru, Philippines, Poland, Portugal, Romania, Russia, Saudi Arabia, Serbia, Singapore, Slovakia, Slovenia, South Africa, Spain, Sweden, Switzerland, Taiwan, Thailand, Tunisia, Turkey, Uruguay, Venezuela, and Viet Nam.","Z-2248-2013","Class II","ACL TOP 700 CTS; PN 0000280050 Bench top, fully automated, random access analyzer designed specifically for in vitro diagnostic clinical use in the hemostasis laboratory for coagulation and/or fibrinolysis testing in the assessment of thrombosis and/or hemostasis. The systems provide results for both direct hemostasis measurements and calculated parameters. ","Start SN and Date: 09120101, Dec 2009; End SN and Date: 13070304, July 2013",,"185","Potential carryover issue that can can cause shortened APTT clotting times on the instrument. ",7/19/2013,"07/19/2013",9/25/2013,"09/25/2013"
"Devices",65893,"Ongoing","Instrumentation Laboratory Co.","Bedford","MA","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution - USA including AL, AR, AZ, CA, CO, CT, DE, FL, GA, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI, and WV. Internationally to Canada, Argentina, Australia, Austria, Belarus, Belgium, Brazil, Brunei, Chile, China, Colombia, Costa Rica, Czech Republic, Denmark, Dubai, Finland, France, Germany, Great Britian, Greece, Guatemala, Hong Kong, Hungary, India, Ireland, Israel, Italy, Japan, Korea, Kuwait, Luthuania, Luxembourg, Malaysia, Mexico, Netherlands, New Zealand, Norway, Panama, Peru, Philippines, Poland, Portugal, Romania, Russia, Saudi Arabia, Serbia, Singapore, Slovakia, Slovenia, South Africa, Spain, Sweden, Switzerland, Taiwan, Thailand, Tunisia, Turkey, Uruguay, Venezuela, and Viet Nam.","Z-2245-2013","Class II","ACL TOP 700; PN 0000280010 Bench top, fully automated, random access analyzer designed specifically for in vitro diagnostic clinical use in the hemostasis laboratory for coagulation and/or fibrinolysis testing in the assessment of thrombosis and/or hemostasis. The systems provide results for both direct hemostasis measurements and calculated parameters.","Start SN and Date: 09080100, Aug 2009 End SN and Date: 13070559, July 2013",,"311","Potential carryover issue that can can cause shortened APTT clotting times on the instrument. ",7/19/2013,"07/19/2013",9/25/2013,"09/25/2013"
"Devices",65893,"Ongoing","Instrumentation Laboratory Co.","Bedford","MA","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution - USA including AL, AR, AZ, CA, CO, CT, DE, FL, GA, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI, and WV. Internationally to Canada, Argentina, Australia, Austria, Belarus, Belgium, Brazil, Brunei, Chile, China, Colombia, Costa Rica, Czech Republic, Denmark, Dubai, Finland, France, Germany, Great Britian, Greece, Guatemala, Hong Kong, Hungary, India, Ireland, Israel, Italy, Japan, Korea, Kuwait, Luthuania, Luxembourg, Malaysia, Mexico, Netherlands, New Zealand, Norway, Panama, Peru, Philippines, Poland, Portugal, Romania, Russia, Saudi Arabia, Serbia, Singapore, Slovakia, Slovenia, South Africa, Spain, Sweden, Switzerland, Taiwan, Thailand, Tunisia, Turkey, Uruguay, Venezuela, and Viet Nam.","Z-2247-2013","Class II","ACL TOP 700 LAS; PN 0000280030 Bench top, fully automated, random access analyzer designed specifically for in vitro diagnostic clinical use in the hemostasis laboratory for coagulation and/or fibrinolysis testing in the assessment of thrombosis and/or hemostasis. The systems provide results for both direct hemostasis measurements and calculated parameters. ","Start SN and Date: 08120100, Dec 2008; End SN and Date: 13070172, July 2013",,"56","Potential carryover issue that can can cause shortened APTT clotting times on the instrument. ",7/19/2013,"07/19/2013",9/25/2013,"09/25/2013"
"Devices",65893,"Ongoing","Instrumentation Laboratory Co.","Bedford","MA","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution - USA including AL, AR, AZ, CA, CO, CT, DE, FL, GA, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI, and WV. Internationally to Canada, Argentina, Australia, Austria, Belarus, Belgium, Brazil, Brunei, Chile, China, Colombia, Costa Rica, Czech Republic, Denmark, Dubai, Finland, France, Germany, Great Britian, Greece, Guatemala, Hong Kong, Hungary, India, Ireland, Israel, Italy, Japan, Korea, Kuwait, Luthuania, Luxembourg, Malaysia, Mexico, Netherlands, New Zealand, Norway, Panama, Peru, Philippines, Poland, Portugal, Romania, Russia, Saudi Arabia, Serbia, Singapore, Slovakia, Slovenia, South Africa, Spain, Sweden, Switzerland, Taiwan, Thailand, Tunisia, Turkey, Uruguay, Venezuela, and Viet Nam.","Z-2249-2013","Class II","ACL TOP 300 and ACL TOP 300 CTS (Japan); PN 0000280060 Bench top, fully automated, random access analyzer designed specifically for in vitro diagnostic clinical use in the hemostasis laboratory for coagulation and/or fibrinolysis testing in the assessment of thrombosis and/or hemostasis. The systems provide results for both direct hemostasis measurements and calculated parameters. ","Start SN and Date: 12060256, Jun 2012; End SN and Date: 13070837, July 2013 and Start SN and Date: 11120131J, Dec 2011; End SN and Date: 13060320J, Jun2013",,"662","Potential carryover issue that can can cause shortened APTT clotting times on the instrument. ",7/19/2013,"07/19/2013",9/25/2013,"09/25/2013"
"Drugs",65894,"Ongoing","Bethel Nutritional Consulting, Inc","New York","NY","US","Voluntary: Firm Initiated","Press Release","Nationwide, Puerto Rico, and internet sales","D-371-2014","Class I","Quick Thin (citrus aurantium extract, sweet potato fiber, cyamopsis gum powder, alfalfa, mulberry leaf, guarana, spirulina) capsules, 400 mg, 30-count bottle, Distributed by: Bethel, Inc., Tel: (212) 568-5330.","Lot 10032011, Exp 10/14",".","9,121 bottles ","Marketed Without An Approved NDA/ANDA: FDA analysis detected the presence of sibutramine, N-Desmethylsibutramine and phenolphthalein. Sibutramine and phenolphthalein were previously available drug products but were removed from the U.S. market making these products unapproved new drugs.",8/5/2013,"08/05/2013",12/26/2013,"12/26/2013"
"Drugs",65894,"Ongoing","Bethel Nutritional Consulting, Inc","New York","NY","US","Voluntary: Firm Initiated","Press Release","Nationwide, Puerto Rico, and internet sales","D-372-2014","Class I","Bethel Advance (bitter orange, mulberry leaf, cassia seed extract, jobstear seed, spirulina, starch, kola nut) capsules, 400 mg, 30-count bottles, Distributed by: Bethel, Inc., Tel: (212) 568-5330, UPC 1 60126 41750 9.","Lot 10092011, Exp 2014",".","13,266 bottles","Marketed Without An Approved NDA/ANDA: FDA analyses detected the presence of phenolphthalein, N-di-Desmethylsibutramine, and trace amounts of sibutramine and N-Desmethylsibutramine. Sibutramine and phenolphthalein were previously available drug products but were removed from the U.S. market making these products unapproved new drugs.",8/5/2013,"08/05/2013",12/26/2013,"12/26/2013"
"Drugs",65895,"Ongoing","Jack Rabbit, Inc","Melbourne","FL","US","Voluntary: Firm Initiated","E-Mail","Nationwide","D-021-2014","Class I","J.R. Jack Rabbit All Natural Herbal Supplement, One tablet can last 24-72 hours, 4-count tablets per blister pack, Order at: www.jackrabbitfourpack.com, Jack Rabbit Inc., 4355 Dow Road, Melbourne, FL 32934","Lot #: 2510 Exp 04/01/15",".","1,000 Tablets","Marketed without an Approved NDA/ANDA: Laboratory analysis conducted by the FDA has determined that J.R. Jack Rabbit Male Enhancement product was found to contain two undeclared active pharmaceutical ingredients: sildenafil and tadalafil.",8/12/2013,"08/12/2013",12/4/2013,"12/04/2013"
"Devices",65897,"Ongoing","DePuy Spine, Inc.","Raynham","MA","US","Voluntary: Firm Initiated","Letter","Nationwide Distribution including the states of AR, AZ, CA, CO, CT, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, MI, MN, MO, MT, NC, ND, NE, NH, NJ, NY, OH, OK, OR, PA, SC, SD, TN, TX, VA, WA, WI, WV, and WY.","Z-2289-2013","Class II","PIPELINE LS ACCESS SYSTEM, 4th Dilator, 18 mm, Insulated The PIPELINE LS Dilators and Holding Clip are intended for sequential dilation of soft tissue and enabling proper placement of the Pipeline LS Retractor.","287105018",".","100 units","Dilators and Holding Clip are being used for a secondary function of neuromonitoring, for which it is not 510(k) cleared. ",7/31/2013,"07/31/2013",10/30/2013,"10/30/2013"
"Devices",65897,"Ongoing","DePuy Spine, Inc.","Raynham","MA","US","Voluntary: Firm Initiated","Letter","Nationwide Distribution including the states of AR, AZ, CA, CO, CT, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, MI, MN, MO, MT, NC, ND, NE, NH, NJ, NY, OH, OK, OR, PA, SC, SD, TN, TX, VA, WA, WI, WV, and WY.","Z-2288-2013","Class II","PIPELINE LS ACCESS SYSTEM, 3rd Dilator, 14 mm Insulated The PIPELINE LS Dilators and Holding Clip are intended for sequential dilation of soft tissue and enabling proper placement of the Pipeline LS Retractor.","287105014",".","102 units","Dilators and Holding Clip are being used for a secondary function of neuromonitoring, for which it is not 510(k) cleared. ",7/31/2013,"07/31/2013",10/30/2013,"10/30/2013"
"Devices",65897,"Ongoing","DePuy Spine, Inc.","Raynham","MA","US","Voluntary: Firm Initiated","Letter","Nationwide Distribution including the states of AR, AZ, CA, CO, CT, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, MI, MN, MO, MT, NC, ND, NE, NH, NJ, NY, OH, OK, OR, PA, SC, SD, TN, TX, VA, WA, WI, WV, and WY.","Z-2286-2013","Class II","PIPELINE LS ACCESS SYSTEM, 15 Dilator, 5 mm, Insulated The PIPLINE LS Dilators and Holding Clip are intended for sequential dilation of soft tissue and enabling proper placement of the Pipeline LS Retractor.","287105005",".","118 units","Dilators and Holding Clip are being used for a secondary function of neuromonitoring, for which it is not 510(k) cleared. ",7/31/2013,"07/31/2013",10/30/2013,"10/30/2013"
"Devices",65897,"Ongoing","DePuy Spine, Inc.","Raynham","MA","US","Voluntary: Firm Initiated","Letter","Nationwide Distribution including the states of AR, AZ, CA, CO, CT, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, MI, MN, MO, MT, NC, ND, NE, NH, NJ, NY, OH, OK, OR, PA, SC, SD, TN, TX, VA, WA, WI, WV, and WY.","Z-2290-2013","Class II","PIPELINE LS ACCESS SYSTEM, Holding Clip The PIPELINE LS Dilators and Holding Clip are intended for sequential dilation of soft tissue and enabling proper placement of the Pipeline LS Retractor.","287105090",".","198 units","Dilators and Holding Clip are being used for a secondary function of neuromonitoring, for which it is not 510(k) cleared. ",7/31/2013,"07/31/2013",10/30/2013,"10/30/2013"
"Devices",65897,"Ongoing","DePuy Spine, Inc.","Raynham","MA","US","Voluntary: Firm Initiated","Letter","Nationwide Distribution including the states of AR, AZ, CA, CO, CT, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, MI, MN, MO, MT, NC, ND, NE, NH, NJ, NY, OH, OK, OR, PA, SC, SD, TN, TX, VA, WA, WI, WV, and WY.","Z-2287-2013","Class II","PIPELINE LS ACCESS SYSTEM, 2nd Dilator, 10 mm, Insulated The PIPELINE LS Dilators and Holding Clip are intended for sequential dilation of soft tissue and enabling proper placement of the Pipeline LS Retractor.","287105010",".","105 units","Dilators and Holding Clip are being used for a secondary function of neuromonitoring, for which it is not 510(k) cleared. ",7/31/2013,"07/31/2013",10/30/2013,"10/30/2013"
"Devices",65897,"Ongoing","DePuy Spine, Inc.","Raynham","MA","US","Voluntary: Firm Initiated","Letter","Nationwide Distribution including the states of AR, AZ, CA, CO, CT, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, MI, MN, MO, MT, NC, ND, NE, NH, NJ, NY, OH, OK, OR, PA, SC, SD, TN, TX, VA, WA, WI, WV, and WY.","Z-0094-2014","Class II","PIPELINE LS ACCESS SYSTEM, 2nd Dilator, 10 mm, Insulated The PIPELINE LS Dilators and Holding Clip are intended for sequential dilation of soft tissue and enabling proper placement of the Pipeline LS Retractor.","287105010",,"105 units","Dilators and Holding Clip are being used for a secondary function of neuromonitoring, for which it is not 510(k) cleared. ",7/31/2013,"07/31/2013",11/6/2013,"11/06/2013"
"Devices",65897,"Ongoing","DePuy Spine, Inc.","Raynham","MA","US","Voluntary: Firm Initiated","Letter","Nationwide Distribution including the states of AR, AZ, CA, CO, CT, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, MI, MN, MO, MT, NC, ND, NE, NH, NJ, NY, OH, OK, OR, PA, SC, SD, TN, TX, VA, WA, WI, WV, and WY.","Z-0095-2014","Class II","PIPELINE LS ACCESS SYSTEM, 3rd Dilator, 14 mm Insulated The PIPELINE LS Dilators and Holding Clip are intended for sequential dilation of soft tissue and enabling proper placement of the Pipeline LS Retractor.","287105014",,"102 units","Dilators and Holding Clip are being used for a secondary function of neuromonitoring, for which it is not 510(k) cleared. ",7/31/2013,"07/31/2013",11/6/2013,"11/06/2013"
"Devices",65897,"Ongoing","DePuy Spine, Inc.","Raynham","MA","US","Voluntary: Firm Initiated","Letter","Nationwide Distribution including the states of AR, AZ, CA, CO, CT, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, MI, MN, MO, MT, NC, ND, NE, NH, NJ, NY, OH, OK, OR, PA, SC, SD, TN, TX, VA, WA, WI, WV, and WY.","Z-0093-2014","Class II","PIPELINE LS ACCESS SYSTEM, 15 Dilator, 5 mm, Insulated The PIPLINE LS Dilators and Holding Clip are intended for sequential dilation of soft tissue and enabling proper placement of the Pipeline LS Retractor.","287105005",,"118 units","Dilators and Holding Clip are being used for a secondary function of neuromonitoring, for which it is not 510(k) cleared. ",7/31/2013,"07/31/2013",11/6/2013,"11/06/2013"
"Devices",65897,"Ongoing","DePuy Spine, Inc.","Raynham","MA","US","Voluntary: Firm Initiated","Letter","Nationwide Distribution including the states of AR, AZ, CA, CO, CT, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, MI, MN, MO, MT, NC, ND, NE, NH, NJ, NY, OH, OK, OR, PA, SC, SD, TN, TX, VA, WA, WI, WV, and WY.","Z-0093-2014","Class II","PIPELINE LS ACCESS SYSTEM, 15 Dilator, 5 mm, Insulated The PIPLINE LS Dilators and Holding Clip are intended for sequential dilation of soft tissue and enabling proper placement of the Pipeline LS Retractor.","287105005",,"118 units","Dilators and Holding Clip are being used for a secondary function of neuromonitoring, for which it is not 510(k) cleared. ",7/31/2013,"07/31/2013",11/6/2013,"11/06/2013"
"Devices",65897,"Ongoing","DePuy Spine, Inc.","Raynham","MA","US","Voluntary: Firm Initiated","Letter","Nationwide Distribution including the states of AR, AZ, CA, CO, CT, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, MI, MN, MO, MT, NC, ND, NE, NH, NJ, NY, OH, OK, OR, PA, SC, SD, TN, TX, VA, WA, WI, WV, and WY.","Z-0096-2014","Class II","PIPELINE LS ACCESS SYSTEM, 4th Dilator, 18 mm, Insulated The PIPELINE LS Dilators and Holding Clip are intended for sequential dilation of soft tissue and enabling proper placement of the Pipeline LS Retractor.","287105090",,"198 units","Dilators and Holding Clip are being used for a secondary function of neuromonitoring, for which it is not 510(k) cleared. ",7/31/2013,"07/31/2013",11/6/2013,"11/06/2013"
"Devices",65897,"Ongoing","DePuy Spine, Inc.","Raynham","MA","US","Voluntary: Firm Initiated","Letter","Nationwide Distribution including the states of AR, AZ, CA, CO, CT, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, MI, MN, MO, MT, NC, ND, NE, NH, NJ, NY, OH, OK, OR, PA, SC, SD, TN, TX, VA, WA, WI, WV, and WY.","Z-0096-2014","Class II","PIPELINE LS ACCESS SYSTEM, 4th Dilator, 18 mm, Insulated The PIPELINE LS Dilators and Holding Clip are intended for sequential dilation of soft tissue and enabling proper placement of the Pipeline LS Retractor.","287105018",,"100 units","Dilators and Holding Clip are being used for a secondary function of neuromonitoring, for which it is not 510(k) cleared. ",7/31/2013,"07/31/2013",11/6/2013,"11/06/2013"
"Devices",65897,"Ongoing","DePuy Spine, Inc.","Raynham","MA","US","Voluntary: Firm Initiated","Letter","Nationwide Distribution including the states of AR, AZ, CA, CO, CT, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, MI, MN, MO, MT, NC, ND, NE, NH, NJ, NY, OH, OK, OR, PA, SC, SD, TN, TX, VA, WA, WI, WV, and WY.","Z-0095-2014","Class II","PIPELINE LS ACCESS SYSTEM, 3rd Dilator, 14 mm Insulated The PIPELINE LS Dilators and Holding Clip are intended for sequential dilation of soft tissue and enabling proper placement of the Pipeline LS Retractor.","287105014",,"102 units","Dilators and Holding Clip are being used for a secondary function of neuromonitoring, for which it is not 510(k) cleared. ",7/31/2013,"07/31/2013",11/6/2013,"11/06/2013"
"Devices",65897,"Ongoing","DePuy Spine, Inc.","Raynham","MA","US","Voluntary: Firm Initiated","Letter","Nationwide Distribution including the states of AR, AZ, CA, CO, CT, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, MI, MN, MO, MT, NC, ND, NE, NH, NJ, NY, OH, OK, OR, PA, SC, SD, TN, TX, VA, WA, WI, WV, and WY.","Z-0097-2014","Class II","PIPELINE LS ACCESS SYSTEM, Holding Clip The PIPELINE LS Dilators and Holding Clip are intended for sequential dilation of soft tissue and enabling proper placement of the Pipeline LS Retractor.","287105090",,"198 units","Dilators and Holding Clip are being used for a secondary function of neuromonitoring, for which it is not 510(k) cleared. ",7/31/2013,"07/31/2013",11/6/2013,"11/06/2013"
"Devices",65898,"Ongoing","Siemens Healthcare Diagnostics","Tarrytown","NY","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution - USA (nationwide) and the countries of Australia, Austria, Belgium, Canada, Croatia, Denmark, France, Germany, Greece, Italy, Japan, Malaysia, Netherlands, Norway, Philippines, Portugal, South Korea, Singapore, Slovenia, Spain, Switzerland, Thailand, Turkey, United Kingdom and Vietnam.","Z-0011-2014","Class II","ADVIA 2120/2120i Hematology Systems with ADVIA Autoslide connected to it, SMN 10361162 and SMN 10361798 --- CLASSIFICATION NAME: Counter, Differential Cell, Automated (Particle Counter) The ADVIA 2120/2120i are hematology systems that utilizes the principles of flow cytometry in order to provide complete blood counts. ","All serial numbers connected to the ADVIA 2120/2120i Hematology Systems with ADVIA Autoslide.",,"311 units total (US: 51 units; Foreign: 260 units)","Siemens determined that if an autosampler rack jam error occurs during operation of an ADVIA 2120/2120i connected to an ADVIA Autoslide, it is possible that the next slide processed by the Autoslide could be labeled with the wrong sample identification information.",8/12/2013,"08/12/2013",10/23/2013,"10/23/2013"
"Food",65899,"Ongoing","Quesos Vaca Negra, Inc. ","Hatillo","PR","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Puerto Rico only.","F-1855.2013","Class III","''***Que sos VACA NEGRA***CAP AEZ***Libre DE Lactose y Hormona R-BST***Quesos Vaca Negra, Carr 492 km 0.1, Hatillo, PR***''","392-07",,"8 wheels (approximately 3.5 kg each)","Positive test results for Generic E. coli ",8/5/2013,"08/05/2013",9/4/2013,"09/04/2013"
"Food",65901,"Ongoing","American Yeast Corporation","Baltimore","MD","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","The recalled products were distributed to MD, CT, PA, and NY","F-1895-2013","Class II","Liquid Yeast Cream, Bulk, in tanker truck quantities, refrigerated 33F-45F","Bulk production lots: 189A13842B 189A79022B 188A79021B 188A79021B 189A79022B 189A79022B 189A79022B 189A79022B 188A13831B",,"44,553 gallons","Bulk liquid yeast is contaminated with Salmonella.",7/9/2013,"07/09/2013",9/25/2013,"09/25/2013"
"Devices",65902,"Ongoing","Stryker Howmedica Osteonics Corp.","Mahwah","NJ","US","Voluntary: Firm Initiated","Letter","Nationwide Distribution","Z-2130-2013","Class II","Stryker Howmedica Osteonics Triathlon tibial alignment ankle clamp extramedullary (EM) referencing instrument (Cat. No. 6541-2-609), for use in Total Knee Arthroplasty (TKA) when the surgeon elects to use Stryker's Triathlon Total Knee System in conjunction with EM referencing. Non-Sterile Instrument.","Catalog #6541-2-609 All lot codes",,"10,537 units","Stryker Orthopaedics has received complaints associated with cracks or fracture of the Triathlon Tibial Alignment Ankle Clamp, an instrument.",7/2/2013,"07/02/2013",9/4/2013,"09/04/2013"
"Devices",65905,"Ongoing","Medical Indicators, Inc.","Pennington","NJ","US","Voluntary: Firm Initiated","Letter","Nationwide distribution: USA including states of: CA, GA, FL, IN, NY, NV OH, PA, TN,TX, VA, and WI.","Z-2162-2013","Class II","Tempa DOT Single-Use Clinical Thermometer Medical Indicators Made in U.S.A. by Medical Indicators, Inc. 16 Thomas J Rhodes Industrial Drive, Hamilton, NJ 08619 USA Phone 1.888.737.1601 www.medicalindicators.com Per 3M website (this product line was recently bought by Medical Indicators from 3M) and labeling in 806, TempaDOT thermometers are individually wrapped, single-use, disposable clinical thermometers for oral or axillary use.","Lots 06068, 06083, 06112, 06126, 06129, 06138, 06153, 06219, and 06225",".","111,800 boxes (5,590 full boxes)","TempaDot products may have been mislabeled.",7/10/2013,"07/10/2013",9/18/2013,"09/18/2013"
"Food",65906,"Ongoing","Zip International Group LLC.","Edison","NJ","US","Voluntary: Firm Initiated","FAX","NY","F-1865-2013","Class I","Baltic Sprats in Spicy Brine Net Wt. 15.8 oz. Prod. of Latvia Distributed by Zip International Group LLC 160 Raritan Center Parkway Unit #6 Edison NJ 08837 T 732-225-3600 UPC 4750217602547","12-10-2013 ",".","50 cases","Baltic Sprats in Spicy Brine may be contaminated with Listeria monocytogenes.",8/1/2013,"08/01/2013",9/11/2013,"09/11/2013"
"Food",65907,"Ongoing","Evershing International Trading Inc.","San Jose","CA","US","Voluntary: Firm Initiated","Letter","CA, WA, OR","F-0077-2014","Class II","Coconut Tree Brand; Mut Gung Non; Ginger Candy; Ing: Ginger, Sugar, Water Sold in 8 oz sealed plastic pouches, and 12 oz sealed shrink wrapped plastic tubs. P. By: E.T.I. San Jose, CA","8 oz UPC: 000008000750 12 oz UPC: 000000991711",".","XX","California Department of Public Health tested Ginger Candy and found that it may contain as much as .012 ppm of lead.",7/31/2013,"07/31/2013",10/30/2013,"10/30/2013"
"Devices",65908,"Ongoing","Medicel Ag","Wolfhalden",,"CH","Voluntary: Firm Initiated","E-Mail","Nationwide Distribution.","Z-1984-2013","Class II","Product Name: nanoPOINT Injector System, item number 37-0000-08. Intended to fold and insert a STAAR Surgical Collamer nanoFLEX or Afinity IOLs, through surgical procedure in a human eye. ","Item number 37-0000-08 Lot number of the recalled products: LOT121402",".","68 boxes or 680 units","The firm initiated this recall of one lot (121402) of nanoPOINT Injectors after they noticed that Tyvek lids might have been damaged and, therefore, the stability of the sterile barrier might be negatively affected.",8/5/2013,"08/05/2013",8/28/2013,"08/28/2013"
"Food",65910,"Ongoing","Heeren Bros Inc","Grand Rapids","MI","US","Voluntary: Firm Initiated","Telephone","small independent retail stores in Michigan","F-1854-2013","Class I","Cardboard BIN LABEL: 03808 LOT #: 09000101, MELON CANTALOUPE..., 80-90 CT , 07/22/13 cantaloupes themselves are not labeled."," Lot 09000101, 07/22/13 on cardboard bin (box)",,"5,400 ","Heeren Brothers Produce is recalling Athena cantaloupes distributed to small independent grocers in Michigan July 23-26, after routine testing by FDA found product contaminated with Listeria monocytogenes, an organism that can cause serious and sometimes fatal infections in young children, the elderly or others with weak immune systems. Healthy individuals may suffer short-term symptoms, such as high fever, severe headache, stiffness, nausea, abdominal pain or diarrhea. Listeria can cause miscarriages and stillbirths in pregnant women.",8/5/2013,"08/05/2013",9/4/2013,"09/04/2013"
"Biologics",65911,"Ongoing","One Lambda Inc","Canoga Park","CA","US","Voluntary: Firm Initiated","Letter","US nationwide and international: Canada, Saudi Arabia, UK, France, Germany, Greece, Italy, Romania, Slovenia, Netherlands, Russia, Finland, Sweden, Spain and Portugal, Brazil, Chile, Bolivia, Paraguay, Costa Rica, Japan, South Africa, Turkey, Vietnam, China, and Malaysia.","B-2326-13","Class II","HLA Fusion Software; version 2.0.0 SP4.1, Catalog ID FUSPGR","HLA Fusion Software (version 2.0.0, SP4.1; Catalog ID FUSPGR (With Luminex xPONENT Software 3.1)",,"1","HLA Fusion Version 2.0.0-SP4.1, with a defect or glitch causing a conversion error giving incorrect test results for certain beads, was distributed. ",7/26/2013,"07/26/2013",11/6/2013,"11/06/2013"
"Biologics",65911,"Ongoing","One Lambda Inc","Canoga Park","CA","US","Voluntary: Firm Initiated","Letter","US nationwide and international: Canada, Saudi Arabia, UK, France, Germany, Greece, Italy, Romania, Slovenia, Netherlands, Russia, Finland, Sweden, Spain and Portugal, Brazil, Chile, Bolivia, Paraguay, Costa Rica, Japan, South Africa, Turkey, Vietnam, China, and Malaysia.","B-2326-13","Class II","HemoCue Urine Albumin Microcuvettes, 25 Microcuvettes HemoCue AB Angelholm, Sweden The quantitative, rapid, turbidimetric immunoassay of albumin in human urine using a specially designed analyzer, the HemoCue Albumin 201 Analyzer. The system can be used for the quantitative determination of low levels of albumin in urine for the purpose of screening for, diagnosing, monitoring and to supplement the clinical evidence in the treatment of microalbuminuria. The system is designed for testing using spot samples or timed collections. A quantitative result is obtained within 90 seconds. HemoCue Urine Albumin Microcuvettes are for in vitro diagnostic use only. The HemoCue Albumin 201 Analyzer is only to be used with HemoCue Urine Albumin Microcuvettes","Model Number 110608 Lot Number: 1210865, 1210873, 1211878, 1301893, 1302810, 1303836, 1304838, 1304840 and 1304842. Model Number 110610 Lot Number: 1209857, 1210870, 1211874, 1211879, 1212885, 1301803, 1301893, 1302817 and 1302818. Model Number 110611 Lot Number: 1208848, 1208853, 1208854, 1209855, 1209856, 1209858, 1209860, 1209862, 1210863, 1210865, 1210869, 1210871, 1210872, 1210873, 1211875, 1211876, 1211877, 1211880, 1211881, 1212884, 1212887, 1301802, 1301804, 1301805, 1301806, 1302811, 1302812, 1302813, 13028141302815, 1302816, 1302821, 1303823, 1303825, 1303834, 1304837, 1304839, 1304841, 1304843, 1304844, 1304845, 1304846 and 1304847. Model Number 110613 Lot Number: 1303825 Model Number 110615 Lot Number: 1209858, 1211878 Model Number 110616 Lot Number: 1208849, 1208850, 1208851, 1210864, 1210866, 1210867, 1210868, 1210869, 1212883, 1212886, 1212888, 1212889, 1301807, 1301808, 1302809, 1303827, 1303829, 1303830, 1303831, 1303832 and 1303833.",,"42,330 packages/4 boxes/25 microcuvetes","HemoCue AB has become aware of a production related problem involving punctured HemoCue Hb 201 Microcuvettes single pack pouches. ",7/25/2013,"07/25/2013",11/6/2013,"11/06/2013"
"Drugs",65912,"Ongoing","Teva Pharmaceuticals USA, Inc.","Sellersville","PA","US","Voluntary: Firm Initiated","Letter","Nationwide","D-924-2013","Class II","Propranolol Hydrochloride Tablets, USP, 10 mg, Rx Only, 1000 count bottles, Manufactured in Czech Republic by: Teva Czech Industries, sro, Opava komanov, Czech Republic, Manufactured for: Teva Pharmaceuticals USA, Sellersville, PA 18960, NDC 50111-467-03","Lot #: 6A301029, Exp 1/2016; 6A303025, Exp. 3/2016 ",,"9003 Bottles","Failed Tablet/Capsule Specification: Teva is recalling certain lots of Propanolol HCl Tablets, 10 mg due to the potential of some tablets not conforming to weight specification.",8/6/2013,"08/06/2013",9/4/2013,"09/04/2013"
"Devices",65913,"Ongoing","3M Company/3m Espe Dental Products","Saint Paul","MN","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution - USA Nationwide in the states of CA, FL, GA, IN, IA, MO, NV, NJ, NY, PA, SC, TN, TX, WA. and the country of CANADA.","Z-2100-2013","Class II","3M ESPE Unitek Primary Stainless Steel Crowns (First Primary UL4), Product code 902150 (Kit- 112 crowns/kit) and 900114 (Refill- 5 crowns/box). Product Usage: Stainless Steel Crowns are designed to fill the need for long term provisional coverage on adult molars and bicuspids as well as pediatric posterior and anterior teeth. ","Product Code 902150 (Kit) Lot codes N492036, N500930 (not distributed) and N495695 Product Code 900114 (Refill) Lot Codes N486012, N497616 (not distributed) and N483920",,"3409 crowns (2949 US and 460 OUS)","3M ESPE is recalling Unitek Primary Stainless Steel Crowns (First Primary UL4) because these products have been manufactured with the incorrect marginal contour edge.",8/5/2013,"08/05/2013",9/4/2013,"09/04/2013"
"Devices",65914,"Ongoing","SpineNet","Winter Park","FL","US","Voluntary: Firm Initiated","Letter","Distributed to one customer in Florida.","Z-2107-2013","Class II","SpineNet Bone Marrow Aspiration Needle Kit (which is the Ranfac Bone Marrow Aspiration Needle #74150-01M). Use to aspirate bone morrow.","Lot # 22754F16 and #25854I17",,"100 units","SpineNet was marketing this device to be used with SpineNet ACC device without FDA clearance or approval.",2/4/2013,"02/04/2013",9/4/2013,"09/04/2013"
"Devices",65915,"Ongoing","mobility unlimited inc","Allentown","PA","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution - USA Nationwide in the states of AL, AZ, CA, FL, GA, IL, MN, MO, NY, PA, TN, TX, VA, and Canada.","Z-0522-2014","Class II","KayserBetten model IDA beds Product Usage: BED, AC-POWERED ADJUSTABLE HOSPITAL ","Serial Nos.: 227.15.03s.-00.-07.10.0726/1998 228.15.03S.-00.-06.09.0562/1998 227.15.03s.-00.-07.10.0725/1998 227.15.03S.-55.-03.11.0141/1998 227.15.03S.-55.-03.11.0142/1998 226.15.03S.-00.-06.09.0557/1998 228.15.03S.-00.-06.09.0563/1998 225.02.03s.-35.-07.10.0733/1998 227.15.03S.-00.-06.09.0569/1998 227.15.03S.-00.-06.09.0572/1998 227.15.03S.-00.-06.09.0714/1998 228.15.03S.-00.-06.09.0559/1998 228.15.03S.-00.-06.09.0713/1998 227.15.03S.-00.-06.09.0567/1998 227.15.03S.-00.-06.09.0570/1998 228.15.03S.-00.-06.09.0560/1998 225.15.03s.-00.-07.10.0724/1998 228.15.03S.-00-.12.08.1366/1998 228.15.03S.-00.-06.09.0564/1998 225.15.03S.-00.-06.09.0565/1998 225.15.03S.-00.-06.09.0566/1998 225.02.03s.-35.-07.10.0685/1998 225.15.03s.-00.-07.10.0723/1998 227.15.03S.-00.-06.09.0571/1998 227.15.03S.-55.-03.11.0144/1998 225.02.03s.-35.-07.10.0686/1998 226.15.03S.-00.-06.09.0558/1998 225.15.03s.-00.-07.10.0732/1998 227.15.03S.-00.-12.08.1363/1998 227.15.03S.-55.-03.11.0143/1998 225.02.03s.-35.-07.10.0684/1998 225.15.03s.-00.-07.10.0731/1998 228.15.03S.-00.-06.09.0561/1998 ",".","33 beds","Some joints on the doors of a limited number of IDA beds may loosen or separate over time which can cause the doors to drop outward and cause injury. ",4/11/2013,"04/11/2013",12/26/2013,"12/26/2013"
"Devices",65917,"Ongoing","SpineNet","Winter Park","FL","US","Voluntary: Firm Initiated","Letter","USA Nationwide Distribution in the state of Florida","Z-2103-2013","Class II","SpineNet Anterior Cervical Cage, Lordotic, Peek (originally submitted as Daytona Anterior Cervical Cage) Product Usage: Is indicated for use in skeletally mature patients with degenerative disc disease of the cervical spine with accompanying radicular symptoms at one disc level","Ref. No. CL1012-05 Size 10mm x 12mm x 5mm, Ref. No. CL1012-06 Size 10mm x 12mm x 6mm, Ref. No. CL1012-07 Size 10mm x 12mm x 7mm, Ref. No. CL1012-08 Size 10mm x 12mm x 8mm, Ref. No. CL1012-09 Size 10mm x 12mm x 9mm, Ref. No. CL1012-10 Size 10mm x 12mm x 10mm, Ref. No. CL1014-05 Size 12mm x 14mm x 5mm, Ref. No. CL1014-06 Size 12mm x 14mm x 6mm, Ref. No. CL1014-07 Size 12mm x 14mm x 7mm, Ref. No. CL1014-08 Size 12mm x 14mm x 8mm, Ref. No. CL1014-09 Size 12mm x 14mm x 9mm, and Ref. No. CL1014-10 Size 12mm x 14mm x 10mm. ",,"400","The recall decision has been made because because it has recently been determined that the instructions for use (IFU) had certain statements that should have been removed prior to initial product marketing.",2/5/2013,"02/05/2013",9/4/2013,"09/04/2013"
"Devices",65918,"Ongoing","HemoCue AB","Angelholm",,"SE","Voluntary: Firm Initiated","Letter","Worldwide Distribution - Nationwide Distribution including the states of AL, AR, AZ, CA, CA ,CT, FL, GA, HE, ID, IL, IN, LA, MA, ME, MI, MN, MO, MS, NC, NH, NM, NY, OH, PA, SC,TX, UT, VA, VT, WA and WI., and the countries of Australia, Bahrain, Belarus, Canada, Czech Republic, Denmark, Finland, France, Germany, Great Britain, Hong Kong, India, Indonesia, Italy, Kenya, Lesotho, Malawi, Mauritius, Mexico, Myanmar, Nigeria, Norway, Omen, Poland, Qatar, Romania, South Africa, South Africa, South Korea, Spain, Sweden, Taiwan, Tanzania, Ukraine, Yemen and Zambia.","Z-0086-2014","Class II","HemoCue Urine Albumin Microcuvettes, 25 Microcuvettes HemoCue AB Angelholm, Sweden The quantitative, rapid, turbidimetric immunoassay of albumin in human urine using a specially designed analyzer, the HemoCue Albumin 201 Analyzer. The system can be used for the quantitative determination of low levels of albumin in urine for the purpose of screening for, diagnosing, monitoring and to supplement the clinical evidence in the treatment of microalbuminuria. The system is designed for testing using spot samples or timed collections. A quantitative result is obtained within 90 seconds. HemoCue Urine Albumin Microcuvettes are for in vitro diagnostic use only. The HemoCue Albumin 201 Analyzer is only to be used with HemoCue Urine Albumin Microcuvettes","Model Number 110608 Lot Number: 1210865, 1210873, 1211878, 1301893, 1302810, 1303836, 1304838, 1304840 and 1304842. Model Number 110610 Lot Number: 1209857, 1210870, 1211874, 1211879, 1212885, 1301803, 1301893, 1302817 and 1302818. Model Number 110611 Lot Number: 1208848, 1208853, 1208854, 1209855, 1209856, 1209858, 1209860, 1209862, 1210863, 1210865, 1210869, 1210871, 1210872, 1210873, 1211875, 1211876, 1211877, 1211880, 1211881, 1212884, 1212887, 1301802, 1301804, 1301805, 1301806, 1302811, 1302812, 1302813, 13028141302815, 1302816, 1302821, 1303823, 1303825, 1303834, 1304837, 1304839, 1304841, 1304843, 1304844, 1304845, 1304846 and 1304847. Model Number 110613 Lot Number: 1303825 Model Number 110615 Lot Number: 1209858, 1211878 Model Number 110616 Lot Number: 1208849, 1208850, 1208851, 1210864, 1210866, 1210867, 1210868, 1210869, 1212883, 1212886, 1212888, 1212889, 1301807, 1301808, 1302809, 1303827, 1303829, 1303830, 1303831, 1303832 and 1303833.",,"10,356 boxes/50 microcuvettes","HemoCue AB has become aware of a production related problem involving punctured HemoCue Urine Albumin Microcuvettes single pack pouches.",7/16/2013,"07/16/2013",11/6/2013,"11/06/2013"
"Devices",65919,"Ongoing","Boston Scientific Corporation","Maple Grove","MN","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution - USA including AL, AZ, AR, CA, CO, CT, DE, DC, FL, GA, ID, IL, IN, IA, KY, LA, MD, MA, MI, MN, MS, MO, MT, NE, NV,NH,NJ, NY, NC, ND, OH, OK, OR, PA, RI, SC,SC, TN, TX, UT, VA, WA, WV, and WI. Internationally to Algeria, Finland, Japan, Spain, Australia, France, Latvia, Sweden, Austria, Germany, Netherlands, Switzerland, Belgium, Great Britain, Norway, Taiwan, Brazil, Greece, Panama, Turkey, Canada, Hong Kong, Poland, Unit.Arab Emir., China, India, Russian Fed., Colombia, Ireland, Saudi Arabia, Czech Republic, Israel, South Africa, Denmark, Italy, and South Korea.","Z-2137-2013","Class II","Boston Scientific, Small Peripheral Cutting BalloonTM, Sterilized using irradiation: The Peripheral Cutting Balloon Catheters are indicated for Percutaneous Transluminal Angioplasty (PTA) of obstructive lesions of synthetic or native arteriovenous dialysis fistulae. 1) 4.00mm x 15mm Small Peripheral Cutting BalloonTM MonorailTM Microsurgical Dilatation Device, UPN #001BPM4015140F0, Catalogue # BPM4015140F & UPN # M001PCBM4015140F0, Catalogue # PCBM4015140F. 2) 4.00mm x 15mm Small Peripheral Cutting BalloonTM Over-the-Wire Microsurgical Dilatation Device, UPN # M001PCBO4015140F0, Catalogue # PCBO4015140F. ","UPN # 001BPM4015140F0, Catalogue #BPM4015140F. Lot#'s 15778169, 15735527, 15774378, 15788826, 15812347, 15824636, 15825277, 15836626, 15873338, 15891705, 15931291, 15945240, 16057260. UPN# M001PCBM4015140F0, Catalogue #PCBM4015140F, Lot #15756145. UPN # M001PCBO4015140F0, Catalogue #PCBO4015140F, Lot #'s 15688199, 15992736, 16066536, 16141255. ",".","1,331","Boston Scientific is initiating a recall removal of the 4.0mm x 15mm size of Small Peripheral Cutting Balloon (Monorail and Over-the-Wire) Microsurgical Dilatation Devices and Flextome Cutting Balloon (Monorail and Over-the-Wire) Microsurgical Dilation Devices. Boston Scientific has determined that users may experience significant difficulty or inability to remove the protector cap from the device which may result in damage to the device.",7/31/2013,"07/31/2013",9/11/2013,"09/11/2013"
"Devices",65919,"Ongoing","Boston Scientific Corporation","Maple Grove","MN","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution - USA including AL, AZ, AR, CA, CO, CT, DE, DC, FL, GA, ID, IL, IN, IA, KY, LA, MD, MA, MI, MN, MS, MO, MT, NE, NV,NH,NJ, NY, NC, ND, OH, OK, OR, PA, RI, SC,SC, TN, TX, UT, VA, WA, WV, and WI. Internationally to Algeria, Finland, Japan, Spain, Australia, France, Latvia, Sweden, Austria, Germany, Netherlands, Switzerland, Belgium, Great Britain, Norway, Taiwan, Brazil, Greece, Panama, Turkey, Canada, Hong Kong, Poland, Unit.Arab Emir., China, India, Russian Fed., Colombia, Ireland, Saudi Arabia, Czech Republic, Israel, South Africa, Denmark, Italy, and South Korea.","Z-2138-2013","Class II","Boston Scientific, FlextomeTM Cutting BalloonTM, Sterilized using irradiation: 1) 4.00mm x 15mm FlextomeTM Cutting BalloonTM MonorailTM Microsurgical Dilatation Device, UPN #H749CBM3400150 Catalogue # CBM340015 & UPN# H749RB4400150 Catalogue # RB440015 2) 4.00mm x 15mm FlextomeTM Cutting BalloonTM Over-the-Wire Microsurgical Dilatation Device, UPN # H749CBO3400150, Catalogue # CBO340015 The Flextome Cutting Balloon Device is indicated for dilatation of stenoses in coronary arteries for the purpose of improving myocardial perfusion in those circumstances where a high pressure balloon resistant lesion is encountered. In addition, the target lesion should possess the following characteristics: '' Discrete (< 15 mm in length), or tubular (10 to 20 mm in length) '' Reference vessel diameter (RVD) of 2.00 mm - 4.00 mm '' Readily accessible to the device '' Light to moderate tortuosity of proximal vessel segment '' Nonangulated lesion segment (< 45) '' Smooth angiographic contour '' Absence of angiographically visible thrombus and/or calcification. ","UPN # Catalogue # Lot # H749CBM3400150 CBM340015 15777251, 15898645, 16125358. H749RB4400150 RB440015 15780571. H749CBO3400150 CBO340015 15854224. ",".","340","Boston Scientific is initiating a recall removal of the 4.0mm x 15mm size of Small Peripheral Cutting Balloon (Monorail and Over-the-Wire) Microsurgical Dilatation Devices and Flextome Cutting Balloon (Monorail and Over-the-Wire) Microsurgical Dilation Devices. Boston Scientific has determined that users may experience significant difficulty or inability to remove the protector cap from the device which may result in damage to the device.",7/31/2013,"07/31/2013",9/11/2013,"09/11/2013"
"Devices",65920,"Ongoing","HemoCue AB","Angelholm",,"SE","Voluntary: Firm Initiated","Letter","Worldwide distribution which includes the following states: AK, AL, AS, AZ, CA, CO, CT, FL, GA, IA, IL, IN, KS, KY,MD, ME, MI, MN, MO, NC, ND, NE, NJ, NM, NY, OH, OK, OR, SC, SD, TN, TX, UT, VA, WA, WI, VT, WV & WY and the countries of Armenia, Australia, Austria, Belgium, Cyprus, Czech Republic, Denmark, El Salvador Finland, France, Germany, Great Britain, Guatemala, Hong Kong, Israel, Ivory Coast, Netherlands, New Zealand, Norway, Peru, Poland, Russia, South Africa, Sweden, Switzerland and Taiwan.","Z-0101-2014","Class II","HemoCue Hb 201 Microcuvettes, carton/4 boxes/25 pouches of Microcuvettes, HemoCue AB Angelholm, Sweden","Part Number 111715: Lot numbers1208655, 1208658, 1208659, 1208660, 1208663, 1208664, 1209667, 1209669, 1209670, 1209671, 1209672, 1209674, 1209675, 1209677, 1209678, 1210681, 1210683, 1210685, 1210688, 1211690, 1211691, 1211692, 1211694, 1211696, 1211697, 1211699, 1212701, 1212702, 1212703, 1212705, 1212706, 1301708, 1301710, 1301711, 1301712, 1301715, 1301717, 1301719, 1302721, 1302723, 1302725, 1302726, 1303729, 1303734 & 1304737. Part Number 111717: Lot Numbers: 1208657, 1208661, 1208662, 1208665, 1209666, 1209668, 1209673, 1209676, 1210679, 1210680, 1210682, 1210684, 1210686, 1210689, 1211693, 1211695, 1211698, 1212700, 1212704, 1212707, 1301709, 1301713, 1301714, 1301716, 1301718, 1302720, 1302722, 1302724 & 1304738. Part Number 111722: Lot numbers: 1209672, 1210687, 1212701 & 1303727. Part Number 116101; Lot Numbers: 1303730 & 1303735.",,"42,330 packages/4 boxes/25 microcuvetes","HemoCue AB has become aware of a production related problem involving punctured HemoCue Hb 201 Microcuvettes single pack pouches. ",7/25/2013,"07/25/2013",11/6/2013,"11/06/2013"
"Devices",65922,"Ongoing","Stryker Medical Division of Stryker Corporation","Portage","MI","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution - USA including MI, WI, VA and internationally to Canada.","Z-2283-2013","Class II","The FL23SE Bed is an AC-powered adjustable hospital bed with four built-in electric DC motors and remote controls that is intended for medical purposes. It can be operated by the patient or the caregiver to adjust the height and surface contour of the bed. The bed includes movable and latchable siderails. The FL23SE Bed is intended for use with patients for procedures, therapy, recovery in healthcare environments, and to transport patients between bays and procedural rooms. The FL23SE Bed is intended for use with patients for procedures, therapy, recovery in healthcare environments, and to transport patients between bays and procedural rooms.","Model Numbers: FL23SE with nurse call option: OL235017 & OL235018 List of Affected Devices: J60267 J60425 J60009 J60001 J60094 J60095 J60096 J60348 J60349 J60350 J60351 J60352 J60353 J60354 J60360 J60361 J60362 J60363 J60364 J60365 J60366 J60367 J60368 J60369 J60370 J60371 J60372 J60373 J60374 J60375 J60376 J60377 J60378 J60379 J60380 J60381 J60382 J60383 J60384 J60385 J60386 J60387 J60388 J60389 J60390 J60391 J60392 J60393 J60394 J60395 J60396 J60397 J60398 J60399 J60400 J60401 J60402 J60403 J60404 J60405 J60512 ",".","61 units","The nurse call cable (Part Number: QDF23-0571) on the FL23SE Bed is located right under the opening of the bed head box. If an accessory (i.e. IV pole) is inserted into this slot, the circuit directing the nurse call system can be damaged.",8/19/2013,"08/19/2013",10/2/2013,"10/02/2013"
"Devices",65923,"Ongoing","Copan Italia","Brescia",,"IT","Voluntary: Firm Initiated","Letter","Worldwide Distribution - USA (nationwide) including Oregon and California, and internationally to: France, Belgium, Italy, Denmark, Norway, Switzerland, Romania, Finland, Germany, South Africa, Canada, Ireland, UK, Sweden and Japan.","Z-2131-2013","Class III","WASP (Walk Away Specimen Process). Automatic Planting and Streaking Instrument Catalog number: W086 WASP is a fully automated system used to process microbiological specimens in liquid phase for the investigation of infectious microbes.","Serial Numbers: W086-61-084/106/115/119/134/136; W086-050-179; W086-61-087/109/125/127/130/133; W086-050-144/151/153/157/170/171/181/184; W086-61-088/097/100/117; W086-050-177/178/183; W086-61-093; W086-050-143/155; W086-61-096; W086-050-164/169/159/175; W086-61-103/137/141/142; W08661-104/114118/128/138; W086050-182; W08661 111; W08661 113; W08661 124; W08661129/140; W086050150/152/154/185; W08661 139; W086050 147; W08661 110; W086050160/161/162; W086050 180; W086050 187.",".","63 units","The recall of the WASP (Walk Away Specimen Process) instrument was initiated because Copan Italia SpA has upgraded the software concerning the broth inoculation table feature. The upgrade has been considered necessary from the manufacturer in order to eliminate the very low risk of rotation of the broth table when the door is open.",8/9/2013,"08/09/2013",9/11/2013,"09/11/2013"
"Biologics",65924,"Terminated","OneBlood / dba CBCF","Lauderhill","FL","US","Voluntary: Firm Initiated","Letter","Switzerland; Florida","B-2446-13","Class III","Blood and Blood Products for Reprocessing","W036810224582; ",".","1","Blood products, collected from a donor in whom donor suitability was not adequately determined, were distributed.",7/3/2013,"07/03/2013",10/30/2013,"10/30/2013"
"Biologics",65924,"Terminated","OneBlood / dba CBCF","Lauderhill","FL","US","Voluntary: Firm Initiated","Letter","Switzerland; Florida","B-2445-13","Class II","Red Blood Cells","W036810224582; ",".","1","Blood products, collected from a donor in whom donor suitability was not adequately determined, were distributed.",7/3/2013,"07/03/2013",10/30/2013,"10/30/2013"
"Biologics",65925,"Terminated","Plasma Biological Services, Inc","Nashville","TN","US","Voluntary: Firm Initiated","E-Mail","California","B-2447-13","Class II","Source Plasma","NQ126229; NQ126044; NQ125644; NQ125453; NQ125068; NQ124769; NQ124420; NQ124111; NQ123788; NQ123524; NQ123203; NQ122916; NQ122657; NQ122282; NQ122128; NQ121618; NQ121429; NQ121047; NQ120771; NQ120365; ",".","20","Blood products, collected from a donor who had been incarcerated, were distributed. ",6/6/2013,"06/06/2013",10/30/2013,"10/30/2013"
"Biologics",65926,"Terminated","OneBlood, Inc.","Miami","FL","US","Voluntary: Firm Initiated","Letter","Florida","B-2448-13","Class III","Blood and Blood Products for Reprocessing","W036812437523; ",".","1","Blood products, collected from a donor in whom donor suitability was not adequately determined, were distributed.",7/2/2013,"07/02/2013",10/30/2013,"10/30/2013"
"Biologics",65926,"Terminated","OneBlood, Inc.","Miami","FL","US","Voluntary: Firm Initiated","Letter","Florida","B-2449-13","Class II","Red Blood Cells Leukocytes Reduced","W036812437523; ",".","1","Blood products, collected from a donor in whom donor suitability was not adequately determined, were distributed.",7/2/2013,"07/02/2013",10/30/2013,"10/30/2013"
"Biologics",65927,"Terminated","Aurora Area Blood Bank Dba Heartland Blood Centers","Aurora","IL","US","Voluntary: Firm Initiated","Telephone","Illinois","B-2524-13","Class III","Red Blood Cells (Apheresis) Leukocytes Reduced","W039713782345J; ",".","1","Blood product, which did not have the preservative solution added but labeled with a 42 day expiration date, was distributed.",5/16/2013,"05/16/2013",10/30/2013,"10/30/2013"
"Biologics",65928,"Terminated","Interstate Blood Bank, Inc of Wisconsin","Madison","WI","US","Voluntary: Firm Initiated","E-Mail","California","B-2525-13","Class II","Source Plasma","EQ106253; EQ105947; EQ105459; EQ105170; EQ104654; EQ124089; EQ123960; EQ123314; EQ122809; EQ122671; EQ122209; EQ122069; EQ121555; EQ121413; EQ120915; EQ120791; EQ120126; EQ119852; EQ119408; EQ119135; EQ118703; EQ118393; EQ117915; EQ117613; EQ117124; EQ116884; EQ116419; EQ116185; EQ115852; EQ115647; EQ115360; EQ115201; EQ114725; EQ114465; EQ113950; EQ113660; EQ113179; EQ112872; EQ112372; EQ111782; EQ111478; EQ110987; EQ110222; EQ109101; EQ108674; EQ107866; EQ107498; EQ107057; EQ106737; ",".","49","Blood products, collected from a donor whose scheduled physical examination was incomplete, were distributed.",5/10/2013,"05/10/2013",10/30/2013,"10/30/2013"
"Biologics",65929,"Terminated","OneBlood, Inc.","Lantana","FL","US","Voluntary: Firm Initiated","Letter","Switzerland; Florida","B-2526-13","Class II","Red Blood Cells","2640057; ",".","1","Blood products, collected from a donor for whom donor suitability was not adequately determined, were distributed.",4/12/2013,"04/12/2013",10/30/2013,"10/30/2013"
"Biologics",65929,"Terminated","OneBlood, Inc.","Lantana","FL","US","Voluntary: Firm Initiated","Letter","Switzerland; Florida","B-2528-13","Class III","Blood and Blood Products for Reprocessing","2640057; ",".","1","Blood products, collected from a donor for whom donor suitability was not adequately determined, were distributed.",4/12/2013,"04/12/2013",10/30/2013,"10/30/2013"
"Biologics",65929,"Terminated","OneBlood, Inc.","Lantana","FL","US","Voluntary: Firm Initiated","Letter","Switzerland; Florida","B-2527-13","Class II","Cryoprecipitated AHF","2640057; ",".","1","Blood products, collected from a donor for whom donor suitability was not adequately determined, were distributed.",4/12/2013,"04/12/2013",10/30/2013,"10/30/2013"
"Biologics",65931,"Terminated","OneBlood, Inc.","Hialeah","FL","US","Voluntary: Firm Initiated","Letter","Florida; New York","B-2529-13","Class II","Fresh Frozen Plasma","W036808175079; W036812434119; ",".","2","Blood products, collected from a donor for whom donor suitability was not adequately determined, were distributed.",6/12/2013,"06/12/2013",10/30/2013,"10/30/2013"
"Biologics",65931,"Terminated","OneBlood, Inc.","Hialeah","FL","US","Voluntary: Firm Initiated","Letter","Florida; New York","B-2530-13","Class II","Red Blood Cells","W036808175079; W036812434119; ",".","2","Blood products, collected from a donor for whom donor suitability was not adequately determined, were distributed.",6/12/2013,"06/12/2013",10/30/2013,"10/30/2013"
"Biologics",65932,"Terminated"," Lions Eye Bank For Long Island ","Valley Stream","NY","US","Voluntary: Firm Initiated","Letter","Syria Arab Republic; New York","B-2007-13","Class III","Cornea","2009243C; 2009244C",".","2 corneas","Human corneas, recovered from a donor whose donor eligibility determination failed to ensure that the donor was free from risk factors for, and clinical evidence of infection due to relevant communicable disease agents and diseases, were distributed. ",7/13/2013,"07/13/2013",11/13/2013,"11/13/2013"
"Biologics",65933,"Terminated"," Lions Eye Bank For Long Island ","Valley Stream","NY","US","Voluntary: Firm Initiated","Letter","New York","B-2202-13","Class III","Cornea","201023C; ",".","1 cornea","Human cornea, recovered from a donor whose donor eligibility determination failed to ensure that the donor was free from risk factors for, and clinical evidence of infection due to relevant communicable disease agents and diseases, was distributed. ",7/13/2013,"07/13/2013",11/13/2013,"11/13/2013"
"Biologics",65934,"Terminated"," Lions Eye Bank For Long Island ","Valley Stream","NY","US","Voluntary: Firm Initiated","Letter","New York","B-2091-13","Class III","Cornea","201053C; ",".","1 cornea","Human cornea, recovered from a donor whose donor eligibility determination failed to ensure that the donor was free from risk factors for, and clinical evidence of infection due to relevant communicable disease agents and diseases, was distributed. ",7/13/2013,"07/13/2013",11/13/2013,"11/13/2013"
"Biologics",65935,"Terminated"," Lions Eye Bank For Long Island ","Valley Stream","NY","US","Voluntary: Firm Initiated","Letter","New York","B-2479-13","Class III","Cornea","201015C",".","1 cornea","Human cornea, recovered from a donor whose donor eligibility determination failed to ensure that the donor was free from risk factors for, and clinical evidence of infection due to relevant communicable disease agents and diseases, was distributed.",7/13/2013,"07/13/2013",11/13/2013,"11/13/2013"
"Biologics",65936,"Terminated","Donor Network of Arizona","Phoenix","AZ","US","Voluntary: Firm Initiated","Letter","Arizona","B-2203-13","Class II","Cornea","1301589ODC",".","1 Cornea","Human Cornea, recovered from a donor who was not properly assess for hemodilution, was distributed. ",7/18/2013,"07/18/2013",11/13/2013,"11/13/2013"
"Biologics",65937,"Terminated"," Lions Eye Bank For Long Island ","Valley Stream","NY","US","Voluntary: Firm Initiated","Letter","New York","B-2480-13","Class III","Cornea","200949C; 200950C",".","2","Human corneas, recovered from a donor whose donor eligibility determination failed to ensure that the donor was free from risk factors for, and clinical evidence of infection due to relevant communicable disease agents and diseases, were distributed. ",7/13/2013,"07/13/2013",11/13/2013,"11/13/2013"
"Biologics",65938,"Terminated","Lions VisionGift","Portland","OR","US","Voluntary: Firm Initiated","E-Mail","Thailand; Oregon","B-2580-13","Class III","Cornea","20130169CNOD; 20130169CNOS",".","2 corneas","Human corneas, recovered from a donor whose donor eligibility determination failed to ensure that the donor was free from risk factors for, and clinical evidence of infection due to relevant communicable disease agents and diseases, were distributed. ",8/5/2013,"08/05/2013",11/20/2013,"11/20/2013"
"Biologics",65939,"Terminated","BioLife Plasma Services, L.P.","Casper","WY","US","Voluntary: Firm Initiated","E-Mail","California","B-2531-13","Class II","Source Plasma","12SWYC8777; ",".","1","Blood product, which was not quarantined subsequent to receiving post donation information, was distributed.",6/25/2013,"06/25/2013",10/30/2013,"10/30/2013"
"Biologics",65940,"Terminated"," Lions Eye Bank For Long Island ","Valley Stream","NY","US","Voluntary: Firm Initiated","Letter","Venezuela","B-2481-13","Class III","Cornea","2009185C; 2009186C",".","2 corneas","Human corneas, recovered from a donor whose donor eligibility determination failed to ensure that the donor was free from risk factors for, and clinical evidence of infection due to relevant communicable disease agents and diseases, were distributed. ",7/13/2013,"07/13/2013",11/13/2013,"11/13/2013"
"Biologics",65941,"Terminated"," Lions Eye Bank For Long Island ","Valley Stream","NY","US","Voluntary: Firm Initiated","Letter","Venezuela","B-2482-13","Class III","Cornea","201047C; 201048C",".","2 corneas","Human corneas, recovered from a donor whose donor eligibility determination failed to ensure that the donor was free from risk factors for, and clinical evidence of infection due to relevant communicable disease agents and diseases, were distributed. ",7/13/2013,"07/13/2013",11/13/2013,"11/13/2013"
"Biologics",65942,"Terminated"," Lions Eye Bank For Long Island ","Valley Stream","NY","US","Voluntary: Firm Initiated","Letter","Venezuela","B-2483-13","Class III","Cornea","201045C",".","1 cornea","Human cornea, recovered from a donor whose donor eligibility determination failed to ensure that the donor was free from risk factors for, and clinical evidence of infection due to relevant communicable disease agents and diseases, was distributed. ",7/13/2013,"07/13/2013",11/13/2013,"11/13/2013"
"Biologics",65943,"Terminated"," Lions Eye Bank For Long Island ","Valley Stream","NY","US","Voluntary: Firm Initiated","Letter","Syria Arab Republic","B-2351-13","Class III","Cornea","2010121C; 2010122C",".","2 corneas","Human corneas, recovered from a donor whose donor eligibility determination failed to ensure that the donor was free from risk factors for, and clinical evidence of infection due to relevant communicable disease agents and diseases, were distributed. ",7/13/2013,"07/13/2013",11/13/2013,"11/13/2013"
"Biologics",65944,"Terminated"," Lions Eye Bank For Long Island ","Valley Stream","NY","US","Voluntary: Firm Initiated","Letter","Egypt; New York","B-2352-13","Class III","Cornea","2010157C; 2010158C",".","2 allografts","Human corneas, recovered from a donor whose donor eligibility determination failed to ensure that the donor was free from risk factors for, and clinical evidence of infection due to relevant communicable disease agents and diseases, were distributed.",7/13/2013,"07/13/2013",11/13/2013,"11/13/2013"
"Biologics",65945,"Terminated"," Lions Eye Bank For Long Island ","Valley Stream","NY","US","Voluntary: Firm Initiated","Letter","New York","B-2353-13","Class II","Cornea","201062C",".","1 cornea","Human cornea, recovered from a donor whose donor eligibility determination failed to ensure that the donor was free from risk factors for, and clinical evidence of infection due to relevant communicable disease agents and diseases, was distributed.",7/13/2013,"07/13/2013",11/13/2013,"11/13/2013"
"Biologics",65946,"Terminated"," Lions Eye Bank For Long Island ","Valley Stream","NY","US","Voluntary: Firm Initiated","Letter","Syria Arab Republic; New York","B-2354-13","Class III","Cornea","201057C; 201058C",".","2 corneas","Human corneas, recovered from a donor whose donor eligibility determination failed to ensure that the donor was free from risk factors for, and clinical evidence of infection due to relevant communicable disease agents and diseases, were distributed.",7/13/2013,"07/13/2013",11/13/2013,"11/13/2013"
"Biologics",65947,"Terminated"," Lions Eye Bank For Long Island ","Valley Stream","NY","US","Voluntary: Firm Initiated","Letter","Syria Arab Republic; New York","B-2355-13","Class III","Cornea","201059C; 201060C",".","2 corneas","Human corneas, recovered from a donor whose donor eligibility determination failed to ensure that the donor was free from risk factors for, and clinical evidence of infection due to relevant communicable disease agents and diseases, were distributed.",7/13/2013,"07/13/2013",11/13/2013,"11/13/2013"
"Drugs",65948,"Ongoing","Qualitest Pharmaceuticals","Huntsville","AL","US","Voluntary: Firm Initiated","Letter","Natiowide","D-1036-2013","Class II","K EFFERVESCENT TABLETS, 25 meq POTASSIUM (977 mg), ORANGE FLAVORED, Potassium Bicarbonate Effervescent Tablets For Oral Solution, Rx only, 30 count, Manufactured for: Qualitest Pharmaceuticals, Inc., Huntsville, AL 35811, Manufactured by: Tower Laboratories Ltd., Centerbrook, CT 06409","Lot Number 21230-2, Exp. DEC 2015",".","1680 boxes","LABELING: Label Mix-up: 30 count Effervescent Potassium/Chloride Tablets, may be labeled as 30 count K Effervescent Tablets.",8/8/2013,"08/08/2013",9/18/2013,"09/18/2013"
"Drugs",65948,"Ongoing","Qualitest Pharmaceuticals","Huntsville","AL","US","Voluntary: Firm Initiated","Letter","Natiowide","D-1037-2013","Class II","EFFERVESCENT POTASSIUM/CHLORIDE TABLETS, 25 meq Potassium Chloride (1865 mg), POTASSIUM BICARBONATE AND POTASSIUM CHLORIDE EFFERVESCENT TABLETS FOR ORAL SOLUTION, USP, FRUIT PUNCH FLAVOR, Rx only, 30 count, Manufactured for: Qualitest Pharmaceuticals, Inc., Huntsville, AL 35811, Manufactured by: Tower Laboratories Ltd., Centerbrook, CT 06409","Lot Number 21230-2, Exp. DEC 2015",".","1680 boxes","LABELING: Label Mix-up: 30 count Effervescent Potassium/Chloride Tablets, may be labeled as 30 count K Effervescent Tablets.",8/8/2013,"08/08/2013",9/18/2013,"09/18/2013"
"Veterinary",65949,"Completed","Land O Lakes Purina LLC","Shoreview","MN","US","Voluntary: Firm Initiated","Telephone","Product was sold to one customer in PA.","V-013-2014","Class I","Purina GATES LON Complete PEL DBZ7.2 with Diflubenzuron","Product Code: 1S8H (3000867-201) -- Lot No. 7/15/13",".","16,660 lbs","Dairy cattle feed was manufactured with toxic levels of Monensin. ",7/17/2013,"07/17/2013",12/26/2013,"12/26/2013"
"Devices",65950,"Ongoing","Philips Healthcare Inc.","Andover","MA","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution - US Nationwide including the states of AZ, CA, CO, DE, FL, GA, MO, MS, NC, NH, NY, PA and TX., and the countries of Canada, Australia, China, Czech Republic, France, Germany, Greece, Italy, Netherlands, Portugal, Russia, Saudi Arabia, Slovenia, Spain, Sweden, Switzerland, Turkey, United Arab Emirates and United Kingdom.","Z-2059-2013","Class II","Philips Easy Upgrade DR, Code No: 712086 This system is used for making X-Ray exposures for diagnostics. ","437765/SN09000009, 452854/SN10000003, 463879/SN10000016, 500643/SN12000006,504710/SN12000011, 511454/SN12000018, 519869/SN13000005, 524432/SN13000007, 500643/SN12000006, 436570/SN09000008, 511492/SN12000019, SN09020039, SN09010077, 438946/SN09000011, SN10002064, SN11020126, SN12020282, 516048/SN12000021, SN13020163, 524411/SN13000011, 409205/SN08000002, 438474/SN09000040, 448425/SN10000001, 449743/SN10000010, 461559/SN10000014, 493489/SN11000008, 496231/SN12000003, 434381/SN09000005, 456026/SN10000011, 465845/SN11000005, 471608/SN11000001, 481912/SN11000004, 508150/SN12000015, 524367/SN13000009, 524510/SN13000010, SN07020246, 485916/SN11000007, 428148/SN09000006, 423585/SN09000003, 500351/SN12000009, 506215/SN12000012, 520201/SN13000003, 409442/SN08000003, 419279/SN09000001, 518054/SN13000001, 460532/SN10000013, SN09020304, 443304/SN09000012, 443310/SN09000013, 416734/SN08000005, 420531/SN09000002, 423195/SN09000004, 460544/SN10000017, 454997/SN10000009, 496323/SN12000002, 496324/SN12000001, 399965/SN08000001, 438232/SN09000010, SN09020302, 443840/SN09000014, 452406/SN10000004, 454310/SN10000005, 478444/SN11000003, 502350/SN12000007, 502355/SN12000016, 520759/SN13000006, 434429/SN09000007, 451666/SN10000002, 453781/SN10000008, 453960/SN10000007, 459266/SN10000012, 460755/SN10000015, 466174/SN10000019, 468076/SN10000020, 471702/SN11000002, 499486/SN12000004, 501950/SN12000008, 503132/SN12000010, 507693/SN12000013, 507694/SN12000014, 519994/SN13000004, 520759/SN13000006,SN09001033, SN09020312, SN09000826, SN11000761, 493873/SN11000009, SN12020117, SN12020322, SN12020440 ",,"89","The mirror icon on the bottom of each image could be misinterpreted as a RIGHT lead marker for side indication if the image is mirrored within a PACS system. ",8/8/2013,"08/08/2013",9/4/2013,"09/04/2013"
"Drugs",65951,"Ongoing","Showline Automotive Products, Inc. dba US Soaps Mfg. Company","Raleigh","NC","US","Voluntary: Firm Initiated","Telephone","Nationwide","D-893-2013","Class II","REEVA (triclosan) Antibacterial Hand Soap and Dishwashing Liquid, Green Apple, 0.10%, 24 fl oz. bottle, Distributed by Aldi Inc,. Batavia, IL 60510; UPC 0 4198 1525 8.","Lot #: 02313325GAB4LN1 and 02313325GAB3LN1, Exp 01/23/15",,"11520 bottles","Microbial Contamination of a Non-Sterile Products: Product was found to be contaminated with the bacteria, Sarcina Lutea.",8/6/2013,"08/06/2013",8/21/2013,"08/21/2013"
"Devices",65952,"Ongoing","Aesculap, Inc.","Center Valley","PA","US","Voluntary: Firm Initiated","Letter","Nationwide Distribution.","Z-0031-2014","Class II","UNITRAC Pneumatic Retraction Arm. A support arm used to hold surgical instruments during surgical procedures.","RT040R, all lot numbers",".","217","Changes were implemented to the UNITRAC instructions for use to ensure safe use and potentially extend the life of the product. This included recommending the use of Sterile Cover JG901 and new Quick Release Coupling RT02OR to eliminate the need to sterilize the UNITRAC and a functional check was added prior to use to ensure optimal functionality of the UNITRAC system. ",7/16/2013,"07/16/2013",10/30/2013,"10/30/2013"
"Drugs",65954,"Ongoing","Sanofi-Synthelabo","Laval",,"CA","Voluntary: Firm Initiated","Letter","Canada","D-886-2013","Class II","Rifadin (rifampin) capsules, USP, 150 mg, 100-count capsules per bottle, Manufactured by: Fabrique par Sanofi-Aventis Canada Inc., Laval, Quebec, Canada H7L4A8, DIN # 02091887","Lot # 3099036, Exp 03/2014 ",,"998 Bottles","Subpotent Drug: During review of retain samples, the manufacturer observed low fill in some capsules, which was related to an issue detected with the encapsulating equipment.",2/26/2013,"02/26/2013",8/21/2013,"08/21/2013"
"Devices",65955,"Ongoing","Synthes USA HQ, Inc.","West Chester","PA","US","Voluntary: Firm Initiated","Letter","Nationwide Distribution, including the states of MI, PA, SC, IA, MA, CA, WI, IL, and KS.","Z-0014-2014","Class II","Synthes Midfoot Fusion Bolt 6.5 mm. It is indicated for fracture, fixation, osteotomies, nonunions, and fusions of large bones in the foot and ankle.","Part Nos.: 04.111.210, 04.111.220, 04.111.230. with Lot Nos.; 2294209 through 7587547. ",,"62","A post market safety review following several customer complaints indicated additional clarification was necessary in the Midfoot Fusion Bolt Technique Guide to reduce potential for bolt back-out or migration by emphasizing the need for supplemental fixation. ",3/8/2013,"03/08/2013",10/23/2013,"10/23/2013"
"Food",65956,"Ongoing","Dove Chocolate Discoveries Llc","Mount Arlington","NJ","US","Voluntary: Firm Initiated","Telephone","Nationwide","F-1871-2013","Class I","Dove Chocolate Discoveries Fruit Collection Dark Chocolate - Covered Cranberries, Blueberries, Cherries Net Wt. 18 oz. Distributed by Dove Chocolate Discoveries, LLC A subsidiary of Mars, Incorporated Hackettstown, NJ 07840-1503 USA Item #3265D Each 18 oz box of mislabeled Fruit Collection contains two clear 8 oz polypropylene bags, labeled DK CINN ALMOND . ","lot code 317DAIDS01 Each 18 oz box of mislabeled Fruit Collection contains two clear 8 oz polypropylene bags, labeled DK CINN ALMOND . The interior polypropylene bags are stamped with lot code 308 BC4CP02 which reflects the co-packer of the 8 oz bags (Cano acquired by Coregistics, Wheeling, IL 60090). ",".","Eighteen boxes","Cinnamon Dusted Dark Chocolate Almonds (Item Number: 3059D) were packaged in boxes labeled Fruit Collection (Item Number: 3265D), a mix of Dark Chocolate-Covered Cranberries, Blueberries, and Cherries.",8/9/2013,"08/09/2013",9/11/2013,"09/11/2013"
"Devices",65957,"Ongoing","Advanced Sterilization Products","Irvine","CA","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution - USA (nationwide) and internationally to RU, VE, KW, SA, HU, GB, IT, HK, IL, MX, ZA, PH, GR, AE, IN, CO, KR, AU, IN, ES, SG, MY, TH, TR, TW, SI, BE, PL, EC, CN, JP, PA, DE, VN, CL, and Switzerland, United Kingdom. Israel. Slovenia, Qatar, Panama, Venezuela.","Z-2174-2013","Class II","STERRAD 100NX Cassettes, Product Code: 10144 The STERRAD Sterilization System is a low temperature general purpose sterilizer used to sterilize heat and moisture sensitive reusable medical devices.","Lot/Batch Numbers: 10104001070010*JABIL 10104001070012*JABIL 10104001070037*JABIL 10104001070038*JABIL 10104001070039*JABIL 10104001070040*JABIL 10104001070041*JABIL 10104001080027*JABIL 10104001080020*JABIL 10104001080025*JABIL 10104001080026*JABIL 10104001080028*JABIL 10104001080029*JABIL 10104001080030*JABIL 10104001080031*JABIL 10104001080033*JABIL 10104001080035*JABIL 10104001080034*JABIL 10104001080036*JABIL 10104001080037*JABIL 10104001080095*JABIL 10104001080087*JABIL 10104001080092*JABIL 10104001080090*JABIL 10104001080017*JABIL 10104001080019*JABIL 10104001080088*JABIL 10104001080039*JABIL 10104001080038*JABIL 10104001080041*JABIL 10104001080042*JABIL 10104001080069* 10104001080043*JABIL 10104001080046*JABIL 10104001080085* 10104001080086* 10104001080059* 10104001080060*JABIL 10104001080061* 10104001080063*JABIL 10104001080065*JABIL 10104001080062*JABIL 10104001080048*JABIL 10104001080049*JABIL 10104001080047*JABIL 10104001080050*JABIL 10104001080051*JABIL 10104001080053*JABIL 10104001080052*JABIL 10104001080054*JABIL 10104001080055*JABIL 10104001080056*JABIL 10104001080057*JABIL 10104001080068*JABIL 10104001080058*JABIL 10104001080070*JABIL 10104001080072*JABIL 10104001080073*JABIL 10104001080074*JABIL 10104001080075*JABIL 10104001080076*JABIL 10104001080077*JABIL 10104001080080*JABIL 10104001080081*JABIL 10104001080082*JABIL 10104001080097*JABIL 10104001080084*JABIL 10104001080099*JABIL 10104001080100*JABIL 10104001080098*JABIL 10104001070041*JABIL 10104001070043*JABIL 10104001070042*JABIL 10104001070044*JABIL 10104001070050*JABIL 10104001070053*JABIL 10104001070054*JABIL 10104001070052*JABIL 10104001070051*JABIL 10104001070055*JABIL 10104001070059*JABIL 10104001070058*JABIL 10104001070057*JABIL 10104001070056*JABIL 10104001070061*JABIL 10104001070064*JABIL 10104001070063*JABIL 1041070007*JABIL 1041070015*JABIL 1041070005*JABIL 1041070003*JABIL 1041070006*JABIL 1041070016*JABIL 1041070008*JABIL 1041070017*JABIL 1041070010*JABIL 1041070004*JABIL 1041070011*JABI 1041070018*JABIL 1041070019* 104108006",".","1,923 units","The recall of the STERRAD 100NX Cassettes was initiated because Advanced Sterilization Products (ASP) does not have adequate data to support the effectiveness of the packaging's leak indicator for the entire duration of the STERRAD 100 NX System cassette's 15 month shelf life.",7/25/2013,"07/25/2013",9/18/2013,"09/18/2013"
"Devices",65958,"Ongoing","GE Healthcare, LLC","Waukesha","WI","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution-USA (nationwide) including the states of AZ, CA, CO, FL, GA, IL, IA, IS, LA, MA, MO, NH, NM, NY, OH, OK PA, SC, TX, UT, VA, WA, and WI, and the countries of UNITED KINGDOM, DENMARK, CHILE, ALGERIA, ARGENTINA, AUSTRALIA, AUSTRIA, AZERBAIJAN, BAHRAIN, BELGIUM, CANADA, CZECH REPUBLIC, ECUADOR, EGYPT, ETHIOPIA, FINLAND, FRANCE, FRANCE GUIANA, GERMANY, GUADELOUPE, GUATEMALA, GUYANA, INDIA, INDONESIA, IRAQ, ITALY, JAPAN, JORDAN, KAZAHSTAN, KOREA, KUWAIT, LATVIA, MYANMA, NETHERLANDS, NEW ZEALAND, NORWAY, PAKISTAN, POLAND, ROMANIA, RUSSIA, SAUDI ARABIA, SOUTH AFRICA, SPAIN, SWEDEN SWITZERLAND, TAIWAN, THAILAND, TURKEY, UKRAINE, UZBEKISTAN, and VIETNAM.","Z-0024-2014","Class II","GE PET Discovery 610, PET Discovery 710. Intended for head and whole body attenuation corrected Positron Emission Tomography (PET) imaging. ","MfgLotorSerial# 00000428413CN9 00000429077CN1 00000429247CN0 00000430152CN9 00000430656CN9 00000430999CN3 00000431369CN8 00000429701CN6 00000430064CN6 00000431187CN4 00000429354CN4 00000431447CN2 00000293950HM2 00000429821CN2 00000429946CN7 00000430001CN8 00000293950HM2 00000430632CN0 Shipped Shipped Shipped 00000429572CN1 00000428755CN3 00000428755CN3 00000428868CN4 00000293949HM4 00000428536CN7 00000429820CN4 ",,"28 (4 US & 24OUS)","GE Healthcare has recently become aware of a potential safety issue related with the DMPR function and Screen Saved Images on your scanner which involves Optima CT660, Brivo CT385, Discovery PET/CT 610, Discovery PET/CT 710. The DMPR and Screen Save functionality may possibly generate the same Series UID. It has been seen that some PACS may combine series under a patient using only the Series UID, although all images are correctly annotated. This issue can cause additional images from a different patient and images from two or more patients to appear in one exam.",3/26/2013,"03/26/2013",10/23/2013,"10/23/2013"
"Devices",65958,"Ongoing","GE Healthcare, LLC","Waukesha","WI","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution-USA (nationwide) including the states of AZ, CA, CO, FL, GA, IL, IA, IS, LA, MA, MO, NH, NM, NY, OH, OK PA, SC, TX, UT, VA, WA, and WI, and the countries of UNITED KINGDOM, DENMARK, CHILE, ALGERIA, ARGENTINA, AUSTRALIA, AUSTRIA, AZERBAIJAN, BAHRAIN, BELGIUM, CANADA, CZECH REPUBLIC, ECUADOR, EGYPT, ETHIOPIA, FINLAND, FRANCE, FRANCE GUIANA, GERMANY, GUADELOUPE, GUATEMALA, GUYANA, INDIA, INDONESIA, IRAQ, ITALY, JAPAN, JORDAN, KAZAHSTAN, KOREA, KUWAIT, LATVIA, MYANMA, NETHERLANDS, NEW ZEALAND, NORWAY, PAKISTAN, POLAND, ROMANIA, RUSSIA, SAUDI ARABIA, SOUTH AFRICA, SPAIN, SWEDEN SWITZERLAND, TAIWAN, THAILAND, TURKEY, UKRAINE, UZBEKISTAN, and VIETNAM.","Z-0023-2014","Class II","GE, Optima CT660. Intended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission data. ","Mfg Lot or Serial # 00000426724CN1 00000429656CN2 00000429809CN7 00000430378CN0 00000430460CN6 00000430480CN4 00000430489CN5 00000430646CN0 00000430650CN2 00000430651CN0 00000430737CN7 00000430795CN5 00000430813CN6 00000430951CN4 00000431016CN5 00000431035CN5 00000431141CN1 00000431269CN0 00000431307CN8 00000431350CN8 00000431506CN5 00000425485CN0 00000424498CN4 00000427441CN1 00000428100CN2 00000429970CN7 00000430427CN5 00000431140CN3 00000431442CN3 00000425128CN6 00000425032CN0 00000428566CN4 00000431662CN6 00000431604CN8 00000431721CN0 00000431708CN7 00000428762CN9 00000428780CN1 00000429600CN0 00000429658CN8 00000429818CN8 00000429877CN4 00000430132CN1 00000430186CN7 00000430264CN2 00000430282CN4 00000430296CN4 00000043742YC6 00000043902YC6 00000045606YC1 00000046476YC8 00000429917CN8 00000037723YC4 00000043482YC9 00000046473YC5 00000042457YC2 00000326336HM5 00000026193YC3 00000328747HM1 00000304641HM4 00000304751HM1 00000305380HM8 00000305871HM6 00000308319HM3 00000310013HM8 00000313520HM9 00000320004HM5 00000322646HM1 00000297489HM7 00000302022HM9 00000318966HM9 00000322993HM7 00000040368YC3 00000327365HM3 00000040081YC2 00000041147YC0 00000042968YC8 00000044150YC1 00000044861YC3 00000045907YC3 00000047740YC6 00000044399YC4 00000045314YC2 00000328079HM9 00000325768HM0 00000027396YC1 00000033407YC8 00000325766HM4 00000299338HM4 00000295308HM1 00000030752YC0 00000312781HM8 00000319291HM1 00000319292HM9 00000322992HM9 00000325769HM8 00000310566HM5 00000311079HM8 00000042014YC1 00000048323YC0 00000048013YC7 00000048014YC5 00000048315YC6 00000048317YC2 00000039804YC0 00000040083YC8 00000041145YC4 00000041828YC5 00000042806YC0 00000042965YC4 00000043220YC3 00000043904YC2 00000044524YC7 00000044858YC9 00000045315YC9 00000045317YC5 00000045603YC8 00000043483YC7 00000044862YC1 00000045316YC7 00000045607YC9 00000045909YC9 00000046475YC0 00000046726YC6 00000046727YC4 00000047521YC0 00000296966HM5 00000038151YC7 00000311081HM4 00000311879HM1 00000328746HM3 00000310567HM3 00000316768HM1 00000316770HM7 00000318137HM7 ",,"380 (52 US & 328 OUS)","GE Healthcare has recently become aware of a potential safety issue related with the DMPR function and Screen Saved Images on your scanner which involves Optima CT660, Brivo CT385, Discovery PET/CT 610, Discovery PET/CT 710. The DMPR and Screen Save functionality may possibly generate the same Series UID. It has been seen that some PACS may combine series under a patient using only the Series UID, although all images are correctly annotated. This issue can cause additional images from a different patient and images from two or more patients to appear in one exam.",3/26/2013,"03/26/2013",10/23/2013,"10/23/2013"
"Drugs",65959,"Ongoing","Teva Pharmaceuticals USA, Inc.","Sellersville","PA","US","Voluntary: Firm Initiated","Letter","Nationwide","D-928-2013","Class II","CARBOplatin Injection, 600 mg/60ml, MultiDose, Rx only, Teva Parenteral Medicines, Inc., Irvine, CA 92618 NDC 0703-3249-11","Lot 31314458B, 31314459B exp.08/14, 31315794 exp. 10/14, 31315982B exp.11/14",".","780 vials","Lack of Assurance of Sterility: The required reduction of endotoxin was not met during the annual revalidation of the vial washer.",8/13/2013,"08/13/2013",9/11/2013,"09/11/2013"
"Devices",65960,"Terminated","Berchtold Corp.","N Charleston","SC","US","Voluntary: Firm Initiated","Letter","USA Nationwide Distribution in the states of AL, AZ, CA, CO, CT, FL, GA, HI.IL, IA, KY, LA, MD, MA, MI, MN, MS, NH, NJ, NY, NC, OH, OK, OR, PA, SC, TN, TX, VT, VA, WI and including Canada.","Z-2168-2013","Class II","OPERON D850 Surgical Table Product Usage: Surgical Table","3501110-S10023, 3501110-S10024, 3501110-S10025, 3501110-S10205, 3501110-S10208, 3501110-S10064, 3501110-S10036, 3501110-S10043, 3501110-S10045, 3501110-S10050, 3501110-S10061, 3501110-S10062, 3511110-S10139, 3511110-S10143, 3511110-S10144, 3511110-S10162, 3501110-S10192, 3501110-S10018, 3511110-S10038, 3511110-S10041, 3511110-S10047, 3511110-S10072, 3511110-S10137, 3511110-S10138, 3501110-S10153, 3501110-S10166, 3501110-S10093, 3501110-S10104, 3501110-S10090, 3501110-S10147, 3501110-S10262, 3501110-S10281, 3501110-S10105, 3501110-S10172, 3501110-S10195, 3501110-S10109, 3501110-S10134, 3501110-S10099, 3501110-S10101, 3501110-S10151, 3511110-S10086, 3511110-S10092, 3511110-S10085, 3511110-S10091, 3501110-S10065, 3501110-S10037, 3501110-S10056, 3501110-S10259, 3501110-S10083, 3501110-S10170, 3501110-S10212, 3501110-S10067, 3501110-S10073, 3501110-S10116, 3501110-S10117, 3501110-S10119, 3501110-S10157, 3501110-S10167, 3501110-S10204, 3501110-S10207, 3501110S-10110, 3511110-S10234, 3501110-S10078, 3501110-S10034, 3501110-S10035, 3501110-S10097, 3501110-S10112, 3501110-S10088, 3501110-S10096, 3501110-S10098, 3501110-S10102, 3501110-S10111, 3501110-S10019, 3501110-S10021, 3501110-S10022, 3501110-S10223, 3501110-S10267, 3501110-S10049, 3501110-S10044, 3501110-S10052, 3501110-S10149, 3501110-S10121, 3501110-S10129, 3501110-S10254, 3501110-S10257, 3501110-S10263, 3501110-S10100, 3511110-S10176, 3511110-S10221, 3501110-S10026, 3501110-S10051, 3501110-S10211, 3501110-S10251, 3501110-S10046, 3501110-S10053, 3501110-S10054, 3501110-S10055, 3501110-S10063, 3501110-S10080, 3501110-S10028, 3501110-S10027, 3501110-S10027, 3501110-S10152, 3511110-S10161, 3501110-S10079, 3501110-S10095, 3511110-S10039, 3501110-S10103, 3501110-S10209, 3501110-S10213, 3501110-S10076, 3501110-S10114, 350110-S10118, 3501110-S10126, 3501110-S10128, 3501110-S10136, 3501110-S10154, 3501110-S10156, 3501110-S10158, 3501110-S10258, 3501110-S10249, 3501110-S10256, 3501110-S10260, 3501110-S10261, 3501110-S10031, 3501110-S10210, 3501110-S10277, 3501110-S10070",".","263","Table was not lowering.",4/16/2012,"04/16/2012",9/18/2013,"09/18/2013"
"Biologics",65961,"Terminated","Mid-South Regional Blood Center","Memphis","TN","US","Voluntary: Firm Initiated","FAX","Tennessee","B-2532-13","Class II","Platelets","W227713402838; ",".","1","Blood product, which was collected from a donor who traveled to a malarial endemic area, was distributed.",7/22/2013,"07/22/2013",10/30/2013,"10/30/2013"
"Biologics",65962,"Terminated","Community Blood Bank of Lancaster County Medical Society","Lincoln","NE","US","Voluntary: Firm Initiated","FAX","Michigan","B-2533-13","Class II","Red Blood Cells Leukocytes Reduced","W087913304839; ",".","1","Blood product, collected from a donor who traveled to an area considered endemic for malaria, was distributed.",7/8/2013,"07/08/2013",10/30/2013,"10/30/2013"
"Biologics",65963,"Terminated"," Lions Eye Bank For Long Island ","Valley Stream","NY","US","Voluntary: Firm Initiated","Letter","California","B-2544-13","Class II","Cornea","2010345C; 2010346C",".","2 corneas","Human corneas, recovered from a donor whose donor eligibility determination failed to ensure that the donor was free from risk factors for, and clinical evidence of infection due to relevant communicable disease agents and diseases, were distributed.",7/13/2013,"07/13/2013",11/13/2013,"11/13/2013"
"Biologics",65964,"Terminated"," Lions Eye Bank For Long Island ","Valley Stream","NY","US","Voluntary: Firm Initiated","Letter","New York","B-2545-13","Class III","Cornea","2010263C; 2010264C",".","2 corneas","Human corneas, recovered from a donor whose donor eligibility determination failed to ensure that the donor was free from risk factors for, and clinical evidence of infection due to relevant communicable disease agents and diseases, were distributed.",7/13/2013,"07/13/2013",11/13/2013,"11/13/2013"
"Biologics",65965,"Terminated"," Lions Eye Bank For Long Island ","Valley Stream","NY","US","Voluntary: Firm Initiated","Letter","New York","B-2546-13","Class III","Cornea","2010255C; 2010256C",".","2 corneas","Human corneas, recovered from a donor whose donor eligibility determination failed to ensure that the donor was free from risk factors for, and clinical evidence of infection due to relevant communicable disease agents and diseases, were distributed.",7/13/2013,"07/13/2013",11/13/2013,"11/13/2013"
"Biologics",65966,"Terminated"," Lions Eye Bank For Long Island ","Valley Stream","NY","US","Voluntary: Firm Initiated","Letter","New York","B-2543-13","Class III","Cornea","2010243C; 2010244C",".","2 corneas","Human corneas, recovered from a donor whose donor eligibility determination failed to ensure that the donor was free from risk factors for, and clinical evidence of infection due to relevant communicable disease agents and diseases, were distributed. ",7/13/2013,"07/13/2013",11/13/2013,"11/13/2013"
"Drugs",65967,"Ongoing","Marlex Pharmaceuticals, Inc.","New Castle","DE","US","Voluntary: Firm Initiated","Letter","Nationwide.","D-1064-2013","Class II","Acetaminophen Tablets, 500 mg, 100-count bottles, Distributed by: Marlex Pharmaceuticals, Inc., New Castle, DE 19720, List No. 152, NDC 10135-152-01, UPC 3 10135 15201 8. ","Lot #: 3213, Exp 12/13",,"28,387 bottles","CGMP Deviations: The recalled acetaminophen tablet lot was not manufactured under current good manufacturing practices as noted by a recent inspection of the manufacturing firm.",8/8/2013,"08/08/2013",10/9/2013,"10/09/2013"
"Devices",65968,"Completed","Spine Wave, Inc.","Shelton","CT","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Distributed in the states of FL and OR.","Z-2187-2013","Class II","StaXx IB Convex Expandable Implant (25 x 12 x 9 mm), Intervertebral Fusion Device, Lumbar; Catalog Number 11 -1902. Indicated for intervertebral body fusion procedures in skeletally mature patients. ","Lot Numbers: 272L08 and 272L09",".","17 units","A component Superior endplate manufactured from a different polymer than specified",5/14/2013,"05/14/2013",9/18/2013,"09/18/2013"
"Devices",65969,"Ongoing","Synergetics Inc","O Fallon","MO","US","Voluntary: Firm Initiated","Letter","Nationwide Distribution-USA including the states of MO, CO, KY, TN, NC, PA, IL CA, NY, IN, MI, LA, NJ and OH.","Z-0051-2014","Class II","Synergetics 25 gauge Soft Tip Cannula, packaged in 6 units per box. Catalog number: 30.08.25. Single-use 25 gauge cannula used in vitreoretinal surgery.","Lot number: M222240",".","48/6-cannula boxes","One lot of 25 gauge Soft-Tip Disposable Cannulas are co-mingled with 23 gauge cannulas; the product is labeled as 25 gauge cannulas.",7/30/2013,"07/30/2013",10/30/2013,"10/30/2013"
"Devices",65970,"Ongoing","GE Healthcare, LLC","Waukesha","WI","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution - USA (nationwide) Puerto Rico and internationally to AUSTRALIA, AUSTRIA, BAHAMAS, BAHRAIN, BELGIUM, BOLIVIA, BRAZIL, CANADA, CHILE, CHINA, COSTA RICA, CROATIA local name-Hrvatska, CYPRUS, DENMARK, ECUADOR, FRANCE, GERMANY, GREECE, HONG KONG, INDIA, IRELAND, ISRAEL, ITALY, JORDAN, KOREA-REPUBLIC OF, KUWAIT, LITHUANIA, MALAYSIA, MALTA, MEXICO, NETHERLANDS, NEW ZEALAND, NORWAY, OMAN, PAKISTAN, POLAND, PORTUGAL, QATAR, RUSSIAN FEDERATION, SAUDI ARABIA, SINGAPORE, SOUTH AFRICA, SPAIN, SWITZERLAND, TAIWAN, THAILAND, TURKEY, UNITED ARAB EMIRATES, UNITED KINGDOM, and VENEZUELA,","Z-2161-2013","Class II","Tec 6 continuous Flow Vaporizer and Tec 6 Plus Anesthesia Vaporizer. The Datex-Ohmeda Tec 6 Plus and Tec 6 Plus NAD Variant is an electronic vaporizer which delivers the anesthetic agent desflurane. The Tec 6 Plus attaches only to Datex-Ohmeda anesthesia machines equipped with the proprietary Selectatec manifold. The Tec 6 Plus NAD Variant attaches only to NAD anesthesia machines equipped with the NAD exclusion type manifold. ","Part Numbers: X1107-9001-000, X1107-9002-000, X1107-9003-000, X1107-9004-000, X1107-9005-000, X1107-9006-000, X1107-9007-000, X1109-9008-000, X1109-9009-000, X1107-9010-000, X1107-9011-000, X1107-9012-000, X1107-9014-000, X1107-9015-000, X1107-9016-000, X1107-9101-000, X1107-9102-000, X1107-9103-000, X1107-9201-000, X1107-9202-000, X1107-9203-000, X1107-9205-000, X1107-9206-000, X1107-9601-000, X1107-9602-000, X1107-9603-000, X1107-9604-000, X1107-9605-000, X1107-9606-000, X1107-9607-000, X1107-9608-000, X1107-9609-000, X1107-9610-000, X1107-9611-000, X1107-9612-000, X1107-9614-000, X1107-9615-000, X1107-9616-000, X1107-9617-000, M1145610-X, M1220023-X, M1220854-X, M1221495-X, 2064455-X, M1243207-X, X1107-9701-000, X1107-9702-000, X1107-9703-000, X1107-9211-000, X1107-9212-000, X1107-9213-000, X1107-9215-000, X1107-9216-000, X1107-9217-000, X1107-9207-000, X1107-9208-000, 2066725-X, 2066835-X, 2069767-X, 1107-9601-000, 1107-9612-000, M1221495, M1220023, M1243207, 1107-9602-000, 1107-9603-000, 1107-9604-000, 1107-9605-000, 1107-9606-000, 1107-9607-000, 1107-9608-000, 1107-9609-000, 1107-9610-000, 1107-9611-000, 1107-9614-000, 1107-9615-000, 1107-9616-000, 1107-9617-000, M1145610, M1220854, 2064455-001, M1098876, 2066725-001, 2066835-001, 2069767-001, X1107-8003-000, X1107-8006-000, X1107-8007-000, X1107-8008-000, X1107-8012-000, X1107-8013-000, X1107-8014-000, X1107-8015-000, X1107-8016-000, X1107-8017-000, X1107-8018-000, X1107-8019-000",".","31,443 devices (23,947 US, 7496 OUS)","GE Healthcare has recently become aware of a potential safety issue involving the pre-operative check, low pressure leak test at 1% dial setting of the Tec 6 and Tec 6 Plus Vaporizers. The user manual pre-operative check, low pressure leak test may not detect the full range of leaks from seal wear degradation in the vaporizers. If the leak is not detected, it will result in fresh gas leaking to the atmosphere and a reduction in fresh gas delivered to the breathing system. A fresh gas leak in the vaporizer does not affect delivery of the set anesthetic agent concentration but could result in a reduction in the volume of fresh gas(es) delivered to the breathing system. ",7/29/2013,"07/29/2013",9/18/2013,"09/18/2013"
"Food",65971,"Ongoing","Mariposa Baking Co.","Oakland","CA","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","one distributor in CA. Number of retail locations forthcoming.","F-1812-2013","Class II","Penguinos - four cream filled chocolate cupcakes: gluten, wheat & dairy free & vegan; 4 x 2.2oz cupcakes, net wt 8.8 oz. Ingredients: organic unrefined cane sugar, filtered water, expeller pressed canola oil, rice flour, cocoa powder, tapioca starch, potato starch, Ener-G egg Replacer, gluten free rice milk, organic palm oil shortening, salt, baking soda, natural vanilla, powder, cocoa butter, xanthan gum, natural flavors (gluten free and began) baking powder, pure vanilla extract. Mariposa Baking Co., 5427 Telegraph Ave., D3, Oakland, Ca 94609","Lot 73-39 (on outer case) Julian date 17913 printed on plastic film of individually wrapped cupcake. If frozen, expiry date of 9/28/13.",".","48 cases (48 cupcakes per case)","Mariposa Baking received a complaint from consumer who found a piece of coconut in a cupcake. Coconut is not an ingredient of the product and was not listed on the ingredient label",8/12/2013,"08/12/2013",8/28/2013,"08/28/2013"
"Biologics",65972,"Terminated","Eye Bank Of Wisconsin, Inc.","Madison","WI","US","Voluntary: Firm Initiated","Telephone","Wisconsin","B-2494-13","Class III","Cornea","CW102297OD; CW102297OS",,"2 corneas","Human corneas, recovered from a donor whose donor eligibility was initially determined with inaccurate and/or incomplete donor records, were distributed.",8/13/2013,"08/13/2013",10/23/2013,"10/23/2013"
"Biologics",65973,"Terminated","Eye Bank Of Wisconsin, Inc.","Madison","WI","US","Voluntary: Firm Initiated","Telephone","Wisconsin","B-2484-13","Class III","Cornea","CW102297OD; CW102297OS",".","2 corneas","Human Corneas, recovered from a donor who was improperly assessed for hemodilution, were distributed.",8/13/2013,"08/13/2013",11/13/2013,"11/13/2013"
"Biologics",65974,"Terminated","Indiana Blood Center","Indianapolis","IN","US","Voluntary: Firm Initiated","Letter","Indiana","B-2534-13","Class II","Red Blood Cells Leukocytes Reduced","W040712114281; ",".","1","Blood product, collected from a donor who provided history that warranted a deferral, was distributed.",7/1/2013,"07/01/2013",10/30/2013,"10/30/2013"
"Biologics",65975,"Terminated","Virginia Blood Services","Richmond","VA","US","Voluntary: Firm Initiated","Telephone","Pennsylvania; Virginia","B-2535-13","Class III","Red Blood Cells Leukocytes Reduced","W087613930893; W087613930899; W087613930895; W087613930891; ",".","4","Blood products, labeled with an incorrect expiration date, were distributed.",6/18/2013,"06/18/2013",10/30/2013,"10/30/2013"
"Biologics",65975,"Terminated","Virginia Blood Services","Richmond","VA","US","Voluntary: Firm Initiated","Telephone","Pennsylvania; Virginia","B-2536-13","Class III","Fresh Frozen Plasma","W087613930901; ",".","1","Blood products, labeled with an incorrect expiration date, were distributed.",6/18/2013,"06/18/2013",10/30/2013,"10/30/2013"
"Biologics",65976,"Terminated","LifeSource","Rosemont","IL","US","Voluntary: Firm Initiated","Telephone","PA","B-2550-13","Class II","Red Blood Cells","W286812082842",,"1 unit","Blood products, collected from a donor who traveled to a malarial endemic area, were distributed.",6/20/2013,"06/20/2013",11/27/2013,"11/27/2013"
"Biologics",65976,"Terminated","LifeSource","Rosemont","IL","US","Voluntary: Firm Initiated","Telephone","PA","B-2551-13","Class II","Platelets","W286812082842",,"1 unit","Blood products, collected from a donor who traveled to a malarial endemic area, were distributed.",6/20/2013,"06/20/2013",11/27/2013,"11/27/2013"
"Biologics",65977,"Terminated","LifeShare Community Blood Services","Elyria","OH","US","Voluntary: Firm Initiated","FAX","OH","B-2460-13","Class II","Platelets Pheresis Leukocytes Reduced","W04381330216; W04381330216; W043813300576; W043813300576; W043813300766",,"5 unit","Blood products, collected from a donor who traveled to a malarial endemic area, were distributed.",7/12/2013,"07/12/2013",11/27/2013,"11/27/2013"
"Devices",65978,"Ongoing","Covidien LLC","Mansfield","MA","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution - USA Nationwide and the country of Bermuda","Z-2184-2013","Class II","Monoject 100 Units/mL Heparin Lock Flush, 12 mL Syringe with 10 mL Fill Product ID: 8881590121 Product Usage: Both 0.9% Sodium Chloride Flush syringes and 10U/mL or 100U/mL Heparin Lock Flush syringes are sterile, single-use products which are intended for use in flushing and locking compatible intravenous administration sets and indwelling intravenous access devices","Lot Numbers: 13A0084N",".","Unknown","Monoject prefill flush syringes may contain non-sterile water and labeled as saline or heparin",8/16/2013,"08/16/2013",9/18/2013,"09/18/2013"
"Devices",65978,"Ongoing","Covidien LLC","Mansfield","MA","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution - USA Nationwide and the country of Bermuda","Z-2186-2013","Class II","Monoject 100 Units/mL Heparin Lock Flush, 12 mL Syringe with 5 mL Fill Product ID: 8881590125 Product Usage: Both 0.9% Sodium Chloride Flush syringes and 10U/mL or 100U/mL Heparin Lock Flush syringes are sterile, single-use products which are intended for use in flushing and locking compatible intravenous administration sets and indwelling intravenous access devices","Lot Numbers: 13A0084N 13D0824N",".","330,120 units","Monoject prefill flush syringes may contain non-sterile water and labeled as saline or heparin",8/16/2013,"08/16/2013",9/18/2013,"09/18/2013"
"Devices",65978,"Ongoing","Covidien LLC","Mansfield","MA","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution - USA Nationwide and the country of Bermuda","Z-2183-2013","Class II","Monoject 10 Units/mL Heparin Lock Flush, 12 mL Syringe with 5 mL Fill Product ID: 8881580125 Product Usage: Both 0.9% Sodium Chloride Flush syringes and 10U/mL or 100U/mL Heparin Lock Flush syringes are sterile, single-use products which are intended for use in flushing and locking compatible intravenous administration sets and indwelling intravenous access devices","Lot Numbers: 13A0084N",".","Unknown","Monoject prefill flush syringes may contain non-sterile water and labeled as saline or heparin",8/16/2013,"08/16/2013",9/18/2013,"09/18/2013"
"Devices",65978,"Ongoing","Covidien LLC","Mansfield","MA","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution - USA Nationwide and the country of Bermuda","Z-2179-2013","Class II","Monoject 0.9% Sodium Chloride Flush Syringe, 12 mL Syringe with 3 mL Fill Product ID: 8881570123 Product Usage: Both 0.9% Sodium Chloride Flush syringes and 10U/mL or 100U/mL Heparin Lock Flush syringes are sterile, single-use products which are intended for use in flushing and locking compatible intravenous administration sets and indwelling intravenous access devices","Lot Numbers: 13A0084N",".","Unknown","Monoject prefill flush syringes may contain non-sterile water and labeled as saline or heparin",8/16/2013,"08/16/2013",9/18/2013,"09/18/2013"
"Devices",65978,"Ongoing","Covidien LLC","Mansfield","MA","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution - USA Nationwide and the country of Bermuda","Z-2178-2013","Class II","Monoject 0.9% Sodium Chloride Flush Syringe, 12 mL Syringe with 10 mL Fill Product ID: 8881570121 Product Usage: Both 0.9% Sodium Chloride Flush syringes and 10U/mL or 100U/mL Heparin Lock Flush syringes are sterile, single-use products which are intended for use in flushing and locking compatible intravenous administration sets and indwelling intravenous access devices","Lot Numbers: 13A0084N 13A0094 13B0364 13C0514",".","3,235,860 units","Monoject prefill flush syringes may contain non-sterile water and labeled as saline or heparin",8/16/2013,"08/16/2013",9/18/2013,"09/18/2013"
"Devices",65978,"Ongoing","Covidien LLC","Mansfield","MA","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution - USA Nationwide and the country of Bermuda","Z-2180-2013","Class II","Monoject 0.9% Sodium Chloride Flush Syringe, 12 mL Syringe with 5 mL Fill Product ID: 8881570125 Product Usage: Both 0.9% Sodium Chloride Flush syringes and 10U/mL or 100U/mL Heparin Lock Flush syringes are sterile, single-use products which are intended for use in flushing and locking compatible intravenous administration sets and indwelling intravenous access devices","Lot Numbers: 13A0084N",".","Unknown","Monoject prefill flush syringes may contain non-sterile water and labeled as saline or heparin",8/16/2013,"08/16/2013",9/18/2013,"09/18/2013"
"Devices",65978,"Ongoing","Covidien LLC","Mansfield","MA","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution - USA Nationwide and the country of Bermuda","Z-2185-2013","Class II","Monoject 100 Units/mL Heparin Lock Flush, 12 mL Syringe with 3 mL Fill Product ID: 8881590123 Product Usage: Both 0.9% Sodium Chloride Flush syringes and 10U/mL or 100U/mL Heparin Lock Flush syringes are sterile, single-use products which are intended for use in flushing and locking compatible intravenous administration sets and indwelling intravenous access devices","Lot Numbers: 13A0084N",".","Unknown","Monoject prefill flush syringes may contain non-sterile water and labeled as saline or heparin",8/16/2013,"08/16/2013",9/18/2013,"09/18/2013"
"Devices",65978,"Ongoing","Covidien LLC","Mansfield","MA","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution - USA Nationwide and the country of Bermuda","Z-2181-2013","Class II","Monoject 10 Units/mL Heparin Lock Flush, 12 mL Syringe with 10 mL Fill Product ID:8881580121 Product Usage: Both 0.9% Sodium Chloride Flush syringes and 10U/mL or 100U/mL Heparin Lock Flush syringes are sterile, single-use products which are intended for use in flushing and locking compatible intravenous administration sets and indwelling intravenous access devices","Lot Numbers: 13A0084N",".","Unknown","Monoject prefill flush syringes may contain non-sterile water and labeled as saline or heparin",8/16/2013,"08/16/2013",9/18/2013,"09/18/2013"
"Devices",65978,"Ongoing","Covidien LLC","Mansfield","MA","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution - USA Nationwide and the country of Bermuda","Z-2182-2013","Class II","Monoject 10 Units/mL Heparin Lock Flush, 12 mL Syringe with 3 mL Fill Product ID: 8881580123 Product Usage: Both 0.9% Sodium Chloride Flush syringes and 10U/mL or 100U/mL Heparin Lock Flush syringes are sterile, single-use products which are intended for use in flushing and locking compatible intravenous administration sets and indwelling intravenous access devices","Lot Numbers: 13A0084N",".","Unknown","Monoject prefill flush syringes may contain non-sterile water and labeled as saline or heparin",8/16/2013,"08/16/2013",9/18/2013,"09/18/2013"
"Drugs",65979,"Ongoing","Novocol Pharmaceutical of Canada","Cambridge",,"CA","Voluntary: Firm Initiated","E-Mail","Nationwide and Canada","D-923-2013","Class II","Lidocaine Hydrochloride 2% and Epinephrine 1:100,000 Injection, Rx Only, For Dental Block and Infiltration Only, 50 Cartridges per box - 1.7 mL minimum each, NDC #s: a) Octocaine 100, Mfr'ed for Septodont, Louisville, CO, 80027, by Novocol Pharmaceutical of Canada, Inc., Cambridge, Ontario, Canada N1R6X3, 0362-9023-05; b) Superdent, Dist by: Darby Dental Supply Co., Jericho, NY 11753, Made in Canada, 66467-9730-5; and c) Dist by: IQ Dental, 353 Rt 46 W, Bldg C Unit 120, Fairfield, NJ, 07004, made in Canada, 42756-1030-5; Manufactured by: by Novocol Pharmaceutical of Canada, Inc., Cambridge, Ontario, Canada N1R6X3.","Lot #s: D00290 D, Exp 08/2013; D00205 A, Exp 11/2013",,"12,497 Boxes","Subpotent Drug; Two lots of Lidocaine 2% with Epinephrine 1:100,000 Injectable, distributed under the names: Octocaine 100, and 2% Xylocaine Dental, may be subpotent for the epinephrine component.",8/14/2013,"08/14/2013",9/4/2013,"09/04/2013"
"Devices",65980,"Ongoing","Assuramed","Twinsburg","OH","US","Voluntary: Firm Initiated","Letter","Nationwide Distribution including AR, AZ, CA, CO, FL, IL, KY, LA, MI, NJ, NY, OH,OK, OR, SC, TX, UT, and WA.","Z-2197-2013","Class II","Hemoccult II BRAND SENSA elite; MATERIALS AND REAGENTS; Hemoccult II SENSA elite Slides (Test Cares) containing guaiac paper; Hemoccult SENSA Developer-a developing solution containing a stabilized mixture of less than 4.2% hydrogen peroxide, 80% denatured ethyl alcohol and enhancer in an aqueous solution; Applicator Sticks; Patient Screening Kit Dispensing Envelopes with Patient Instructions; Flushable Collection Tissues; Mailing Pouches (for returning completed Test Cares); Hemoccult II SENSA elite Product Instructions; Beckman Coulter, Inc.; 250 S. Kraemer Blvd.; Brea, CA 92821 The Hemoccult II SENSA elite test is a rapid, convenient and qualitative method for detecting fecal occult blood which may be indicative of gastrointestinal disease. It is not a test for colorectal cancer or any other specific diseases. The Hemoccult II SENSA elite test is recommended for professional use as a diagnostic aid during routine physical examinations, for hospital patients to monitor for gastrointestinal bleeding in patients with iron deficiency anemia or recuperating from surgery, peptic ulcer, ulcerative colitis and other conditions, and in screening programs for colorectal cancer when the Patient Instructions are closely followed. Serial fecal specimen analysis is recommended when screening symptomatic patients. The Hemoccult II SENSA elite test and other unmodified guaiac tests are not recommended for use with gastric specimens.","Product Number: 9964130; Lots: All Lots; Independence Medical Catalog Number: 9964130",,"13 units","The products may have been stored at temperatures outside their required storage conditions.",7/16/2013,"07/16/2013",9/25/2013,"09/25/2013"
"Devices",65980,"Ongoing","Assuramed","Twinsburg","OH","US","Voluntary: Firm Initiated","Letter","Nationwide Distribution including AR, AZ, CA, CO, FL, IL, KY, LA, MI, NJ, NY, OH,OK, OR, SC, TX, UT, and WA.","Z-2196-2013","Class II","DiaScreen Liquid Urine Controls: Positive and Negative Assayed Liquid Quality Controls for use with Dipsticks in Routine Urinalysis; Product Number D76004 (4x12 mL bottles) consists of: 2x12mL Positive controls [and] 2x12mL Negative controls; Manufactured for ARKRAY USA, Inc.; Minneapolis, MN 55439 Diascreen liquid urine control is a synthetic control designed to react with commercial urine dipsticks to register listed responses on color reagent pads. It is intended for use in a clinical laboratory as a urine control for qualitative procedures used in chemical determinations. The control is intended to be used exactly as if it were a patient sample to assist in the assessment of the listed analytical procedures.","Product Number: D76004; Lots: All Lots; Independence Medical Catalog Number: CJD76004",,"10 units","The products may have been stored at temperatures outside their required storage conditions.",7/16/2013,"07/16/2013",9/25/2013,"09/25/2013"
"Devices",65980,"Ongoing","Assuramed","Twinsburg","OH","US","Voluntary: Firm Initiated","Letter","Nationwide Distribution including AR, AZ, CA, CO, FL, IL, KY, LA, MI, NJ, NY, OH,OK, OR, SC, TX, UT, and WA.","Z-2198-2013","Class II","ProTime Microcoagulation System; PROTIME CUVETTE AND PROTIME3 CUVETTE; Store the foil-pouched cuvettes refrigerated 2-8C (36 - 36F); MATERIALS PROVIDED; ProTime cuvettes with Tenderlett Plus; or; Protime3 cuvettes with Tenderlett Plus LV; Product Instructions; Antiseptic, gauze (with self-test package only); International Technidyne Corporation; 8 Olsen Avenue; Edison, NJ 08820 USA; a subsidiary of Thoratec Corporation The ProTime Microcoagulation System consists of a portable, battery operated instrument and disposable cuvette for quantitative determination of prothrombin time (PT) from fingerstick whole blood or anticoagulant-free venous whole blood. There are two different types of cuvettes available for use with the ProTime Microcoagulation System: a ProTime cuvette and a ProTime3 cuvette. The ProTime cuvette is black color coded and utilizes three channels for the PT assays and two channels for integral controls. It requires approximately 65 ul of blood (approximately 3 drops). The ProTime3 cuvette is blue color coded and utilizes one channel for PT assay and two channels for integral controls. The ProTime3 cuvette requires approximately 27 ul of blood (approximately 1 large drop). The ProTime Microcoagulation System is intended for professional use in the management of patients treated with oral anticoagulants or for patient self-testing.","*** 1) Product Number: PRO3-25; Lots: All Lots; Independence Medical Catalog Number: 55L2101002; *** 2) Product Number: PRO5-25; Lots: All Lots; Independence Medical Catalog Number: ICPRO525",,"1) 72 units; 2) 56 units","The products may have been stored at temperatures outside their required storage conditions.",7/16/2013,"07/16/2013",9/25/2013,"09/25/2013"
"Devices",65981,"Ongoing","Terumo Cardiovascular Systems Corporation","Elkton","MD","US","Voluntary: Firm Initiated","Letter","Nationwide Distribution including WA, IN, OK, TX, MI, CA, NY, CT, AZ, FL, WV, NC, VA, PA, TN, GA, AL, MA, SC, OH, MS, MO, SD, WI, AR, AND NV.","Z-2261-2013","Class II","Terumo Pall AL6X Arterial Blood Line Filter, labeled in part ***Terumo Cardiovascular Systems Corporation Elkton, MD 21921***, packaged as part of a Terumo Cardiovascular Procedure Kit or as a single, sterile filter unit Single/Sterile Terumo Pall AL6X Arterial Filter: The Terumo Pall AL6X Arterial Filter is indicated for use in cardiopulmonary bypass procedures for the removal of micro-emboli greater than 40 microns in size, including gas emboli, fat emboli and aggregates composed of platelets, red blood cells and other debris from the arterial line and where the flow rate will not exceed 8 liters per minute. Cardiovascular Procedure (Convenience) Kit that includes the Terumo Pall AL6X Arterial Filter: The Cardiovascular Procedure Kits are indicated for use only in the extracorporeal circuit for the cardiopulmonary bypass procedures for which the user designed. The sterile cardiovascular procedure kit is intended to be used one time for periods up to 6 hours. ","Recalled filters sold singly are identified with Part Number AL6X with the following lot codes: MM19, MN23, NC15, ND01, ND08, ND29, NE11, NE18, NE25, NF09, NF31, PA23, PD05, PE02, PF14, PF21, PG04, PG11, PG18, PG25, PH09, PH16, PH30, PK06, PK13, PL24, PM01, PM08, PM22, PM29, PN12, PN26, PP17, PP31, QA07, QA14, QA21, QC04, QC25, QD11, QD18, QD25, QE08, QE15, QE22, QE29, QF06, QF28, MM26, NL12, NM24, NP12, and PA30; Affected filters, also Part # AL6X, packaged within Terumo Cardiovascular Convenience Kits are identified with the following lot codes: PN19, QA14, QC11R, QD04, QE15, QF06, QF13, NM31, NP05, PC20, PD05, QF28, QC04, PD26, PG04, PE23R, PK13, PK20, QA21, QC11, QC11A, QD11, QE01, PL17, QE08, NK08, PG25, PN26, QC18, NN07, NN07R, PA16, PA16R, PC27, PC27R, PF07, PL24, PD12, PE09, PE30, PH09, PL10, PE23, PF14, PG18, PK06, PM01, PM22, PN12, QA02, QA28, QC25, QD25, NK01, NK08R, PH23, PH16, PL10A, PM15, PP10, PP17, QD18, QE22, NM17, NM17A, PC06, PC06R, PE09R, QE01A, QE15A, QE15T, QE15TA, QE15TC, QF13T, QF20, QF20T, NA10R, NA17R, ND14, ND28, ND28T, NE11T, NE18, NF23, NG06, NG20, NH11, NH18, NK15, NL12, NL26, NM03, NM10, NM24, NN14, NN28, NP12, PA30, PC13, PD19, PE16, PF07A, PF21, PK27, PK27A, PL04, PM08, PP03, QA14T, QE29, QF28T, QF28TA, PG11, PH30, PH30A, PN26A, QA07, NH25, NK29, PE02, PF29, PN19, QG17, PK13A, QD11A, MN22, NE25, NF31, PM29, PA09, QG03, PA02, PH23T, PG11T, QC18R, QF06A, PH09T, PH09TA, QF13TA, QF20TA, and QF20TC ",".","15,817 filters","Medical device used in cardiovascular procedures is defective.",7/26/2013,"07/26/2013",10/2/2013,"10/02/2013"
"Food",65982,"Ongoing","Reaction Nutrition LLC","Carnegie","PA","US","Voluntary: Firm Initiated","Letter","Nationwide.","F-1879-2013","Class I","Clinical LIVE Dietary Supplement Immune Support 694.325 mg 90 capsules Distributed by Reaction Nutrition, LLC., Carnegie, PA.","lot # PB0091512, exp. date 8/2014, UPC code 283333900111",".","600 ","The product contained an undeclared allergen, Colostrum, which is considered a dairy product and therefore requires an allergen statement on the label. ",11/7/2012,"11/07/2012",9/18/2013,"09/18/2013"
"Food",65983,"Ongoing","Lucy's Kitchen, Inc.","San Juan","PR","US","Voluntary: Firm Initiated","Letter","PR only","F-1894-2013","Class II","''***SUPERBUDIN'' ","No codes ",,"150 units","Undeclared allergens: wheat. and soy One of the ingredients is ''Super Pan'' that contains wheat as a sub-ingredient. The coconut milk is another ingredient that contains ''soy lecithin'' and it is undeclared.",8/20/2013,"08/20/2013",9/25/2013,"09/25/2013"
"Food",65983,"Ongoing","Lucy's Kitchen, Inc.","San Juan","PR","US","Voluntary: Firm Initiated","Letter","PR only","F-1893-2013","Class II","''***SUPERPAN***Tu Pan Natural***''","3107291300, 3107301300, 3107311300, 3108011300, 3108031300, 3208051300, 3208061300, 3208971300, 3208081300, 3208091300",,"6985 units","Undeclared allergens: wheat. The list of ingredients declare ''semolina durum'' but not the common name ''wheat''.",8/20/2013,"08/20/2013",9/25/2013,"09/25/2013"
"Devices",65984,"Ongoing","Edwards Lifesciences, LLC","Irvine","CA","US","Voluntary: Firm Initiated","Letter","Nationwide Distribution including MO and MI.","Z-2189-2013","Class II","''***Flo Trac Sensor Model MHD85***'' Sterile, single use kit that monitors pressures when attached to pressure monitoring catheters.","595531157",".","35 units","The Edwards Lifesciences FloTrac Sensor is being recalled due to a manufacturing non-conformance related to incorrect packaging configuration where the IFU was placed on top of the Tyvek instead of being placed at the bottom of the box. There is no evidence available at this time that could validate the sterility of this incorrect packaging configuration. ",7/31/2013,"07/31/2013",9/18/2013,"09/18/2013"
"Devices",65985,"Ongoing","Custom Ultrasonics, Inc.","Ivyland","PA","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution: USA (nationwide) and Internationally to Canada, Slovakia Republic, Sydney and Peru.","Z-0426-2014","Class II","Custom Ultrasonics System 83 Plus 2 and Plus 9 Endoscope Washer/Disinfector. ","Multiple serial numbers",".","118","Certain System 83 Plus 2 and System 83 Plus 9 units running the Windows 7 operating system were not fully validated prior to distribution. ",3/12/2013,"03/12/2013",12/4/2013,"12/04/2013"
"Veterinary",65986,"Ongoing","Sparhawk Laboratories Inc","Lenexa","KS","US","Voluntary: Firm Initiated","Letter","Distribution was made to MO and OH.","V-311-2013","Class II","Sparhawk Laboratories, Inc. Atropine Sulfate 1/120 Injectable Solution, each mL of sterile solution contains 0.54 mg. atropine sulfate, packaged in 100-ml. vials, RX, Manufactured for Sparhawk Laboratories, Inc., Lenexa, KS.","Lot number 120078, Exp. 11/2013",,"7,228/100-ml. vials","The lot failed stability at the 12-mo. testing interval (low).",8/5/2013,"08/05/2013",9/4/2013,"09/04/2013"
"Biologics",65987,"Terminated","Community Blood Center, Inc.","Appleton","WI","US","Voluntary: Firm Initiated","Letter","WI","B-2496-13","Class II","Red Blood Cells Leukocytes Reduced","5033025",,"1 unit","Blood product, collected from a donor who was previously deferred, was distributed.",7/17/2013,"07/17/2013",11/27/2013,"11/27/2013"
"Biologics",65989,"Terminated"," Lions Eye Bank For Long Island ","Valley Stream","NY","US","Voluntary: Firm Initiated","Letter","California","B-2547-13","Class III","Cornea","2010313C",".","1 cornea","Human cornea, recovered from a donor whose donor eligibility determination failed to ensure that the donor was free from risk factors for, and clinical evidence of infection due to relevant communicable disease agents and diseases, was distributed.",7/13/2013,"07/13/2013",11/13/2013,"11/13/2013"
"Biologics",65990,"Terminated"," Lions Eye Bank For Long Island ","Valley Stream","NY","US","Voluntary: Firm Initiated","Letter","New York","B-2548-13","Class III","Cornea","201049C",".","1 cornea","Human cornea, recovered from a donor whose donor eligibility determination failed to ensure that the donor was free from risk factors for, and clinical evidence of infection due to relevant communicable disease agents and diseases, was distributed.",7/13/2013,"07/13/2013",11/13/2013,"11/13/2013"
"Biologics",65991,"Terminated"," Lions Eye Bank For Long Island ","Valley Stream","NY","US","Voluntary: Firm Initiated","Letter","New York; Venezuela","B-2558-13","Class III","Cornea","2009227C; 2009228C; ",".","2 corneas","Human tissue allografts, recovered from a donor whose donor eligibility determination failed to ensure that the donor was free from risk factors for, and clinical evidence of infection due to relevant communicable disease agents and diseases, were distributed.",7/13/2013,"07/13/2013",11/13/2013,"11/13/2013"
"Biologics",65991,"Terminated"," Lions Eye Bank For Long Island ","Valley Stream","NY","US","Voluntary: Firm Initiated","Letter","New York; Venezuela","B-2559-13","Class III","Sclera","2009227SB; 2009227SC",".","2 sclera","Human tissue allografts, recovered from a donor whose donor eligibility determination failed to ensure that the donor was free from risk factors for, and clinical evidence of infection due to relevant communicable disease agents and diseases, were distributed.",7/13/2013,"07/13/2013",11/13/2013,"11/13/2013"
"Devices",65992,"Ongoing","GE Healthcare, LLC","Waukesha","WI","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution - All states in continental USA including DC except AK, AZ, RI and WY. and the countries of : AUSTRALIA, AUSTRIA, AZERBAIJAN, BAHRAIN, BELARUS, BELGIUM, BRAZIL, CANADA, CHILE, CHINA, CZECH REPUBLIC, DENMARK, EGYPT, FINLAND, FRANCE, GERMANY, GREECE, HONG KONG, HUNGARY, INDIA, INDONESIA, ISRAEL, ITALY, JAPAN, KOREA, KUWAIT, LEANON, MARINIQUE, MEXICO, NETHERLANDS, NEW ZEALAND, NORWAY, POLAND, QATAR, ROMANIA, RUSSIA, SAUDI ARABIA, SERBIA, SINGAPORE,SOUTH AFRICA, SPAIN, SWEDEN, SWITZERLAND, TAIWAN, TURKEY, UNITED ARAB EMIRATES, UNITED KINGDOM, LUXEMBOURG, PORTUGAL, VIETNAM and URUGUAY.","Z-2266-2013","Class II","GE 1.5T Signa HDxt, 3.0T Signa HDxt, Signa Vibrant, HD23 Software and the following model numbers: 2395001, 2395001-2, 2395001-3, 2395001-4, 5269997-2, 5269997-4, 2377062-61, 5127452-3, 5127452, 5337894-3, 5337894-4, 5911000-4, 5911000-5, 53085735308573-2. GE Discovery MR750w 3.0T, Discovery MR750 3.0T, Optima MR450w 1.5T, Discovery MR450 1.5T. The 1.5T Signa HDx family and 3.0T Signa HDx family are a whole body magnetic resonance scanner designed to support high resolution, high signal-to-noise ratio, and short scan times. IT is indicated for use as a diagnostic imaging device to produce axial, sagittal, coronal, and oblique images, spectroscopic images, parametric maps, and/or spectra, dynamic images of the structures and/or functions of the entire body, including but not limited to head, neck, TMJ, spine, breast, heart, abdomen, pelvis, joints, prostate, blood vessels, and musculoskeletal regions of the body. Depending on the region of interest being imaged, contrast agents may be used","REF 60850 Mfg Lot or Serial # 00000204882MR5 00000233303MR7 00000241103MR1 00000245171MR4 00000247204MR1 00000173038MR1 00000136104MR7 00000264553MR9 00000265096MR8 00000005532YR7 00000007097YR9 00000007556YR4 00000281841MR7 00000289583MR7 0000SGH919066P 00000013883YR4 0000SGH231PPQK 00002UA2050JKX 00002UA2400LWP 00002UA24315PT 00002UA24315PY 00002UA24315P5 00002UA24907W7 00000266797MRO 00000267189MR0 00000270550MR7 00000283466MR1 00000305180MR2 00000306054MR8 0000267533MR8A Not Available 00000237000MR5 00000226580MR9 00000230105MR9 00000285956MR9 00000305386MR5 00000012562YR5 Not Available 000002UA4907WH 00002UA2400LWZ 00000177845MR5 00000165805MR3 00000836BD4DE2 00000012383YR6 00000269416MR4 Not Available 00002UA2400LWN 00000284254MR0 00000287469MR1 00000304797MR4 00002UA24907WK 00000005220YR9 00002UA2420VVZ 00002UA24907YC 00002UA24907YD 00002UA2510YTL 00000287996MR3 00000934BD5E4F 00000005966YR7 00000919BD5B8F 00000285151MR7 00000275969MR4 00000286019MR5 00000288669MR5 00001008BD6522 00000PH150024A 00000280423MR5 00000283613MR8 00000288416MR1 00000289840MR1 00000291157MR6 00000297685MR0 00000012064YR2 00000012526YR0 00000013660YR6 00000013820YR6 00000015654YR7 00001052XF502C 00001052XF5068 00001105XF5017 0000SGH048S36G 0000SGH105P174 0000SGH150RLYV 0000SGH150RLYX 0000SGH201TZ0V 0000SGH203QRPF 00002UA2050JKD 00002UA2050JL0 00002UA2070RGR 00002UA211170R 00002UA2281GGK 00002UA2281GGL 00002UA22827QF 00002UA2321LKW 00002UA2400LWJ 00002UA2400LWW 00002UA24907WJ 00000026639MR2 00000276261MR5 00000246260MR4 00000273065MR3 00000011594YR9 00000013110YR2 00001048XF5001 0000SGH106PMD7 814 00002UA2050JK7 00002UA2050JL2 00002UA2201G10 00002UA2201G19 00002UA22912Y5 00000264642MR0 00000305822MR9 00000265606MR4 Not Available 00000304307MR2 00000013981YR6 00002UA2400LX2 00000213294MR2 809 811 00000273256MR8 00000221025MR0 00000174670MR0 00000259576MR7 00000288072MR2 00000298886MR3 00000304463MR3 00000002761M65 00000002763M61 00000002766M64 00000003066M68 00000012720M69 00000012955M61 00001001BD631C 00001002BD6379 00001011BD66",".","1,246 (521 US and 725 OUS)","GE Healthcare has recently become aware of a potential safety issue due to non-unique series identifiers embedded in image headers of certain GE MR Products. For ClariView and Screen Save from GVTK (Gems Visualization ToolKit) Viewer, the MR Product can generate image headers with non-unique series identifiers, which when exported to some PACS systems, results in the series being associated with the incorrect study on the PACS. The intended study will not have the correct series listed and an unintended study will have it listed instead. In all cases, patient identifying annotation remains correct. The issue may result in an incorrect diagnosis from the study with mixed patient data, if the series protocol and anatomy on the studies are similar, and the annotation is not noticed.",4/9/2013,"04/09/2013",10/2/2013,"10/02/2013"
"Devices",65993,"Ongoing","B. Braun Medical, Inc.","Allentown","PA","US","Voluntary: Firm Initiated","Letter","Distributed in the states of FL, NY, NJ, and TX.","Z-2166-2013","Class II","Outlook Safety Infusion System Burette Set. For intravenous fluid administration.","Catelog Number 375038, Lot Number 0061317318, Expiration Date: 04/30/2016",".","900","Reports were received of an incorrectly assembled Outlook Safety Infusion System Burette Set (Product Code 375038), and the investigation determined that one of the ULTRASITE injection sites and corresponding low pressure backcheck valve was assembled upside down. ",8/5/2013,"08/05/2013",9/18/2013,"09/18/2013"
"Food",65994,"Ongoing","Terri Lynn Inc.","Elgin","IL","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","US: Nationwide (AK, CT, FL, GA, IA, IL, IN, KS, MD, MI, MT, NC, NJ, NV, OH, PA, WI, WV)","F-0217-2014","Class I","Mixed nuts in a plastic bag labeled in part: PREMIUM QUALITY; Terri Lynn Inc.; Deluxe Mixed; No Peanuts; NET WT. 16 OZ. (1 LB.) 454 g; P.O. BOX 5118 ELGIN, IL 60121","Item Number: 60025; Julian Code: 3180; Lot Number: MO-00551270",,"799 bags","Terri Lynn Inc. ''Deluxe Mixed Nuts No Peanuts'' was found to have undeclared peanuts inside the bag. ",8/12/2013,"08/12/2013",11/27/2013,"11/27/2013"
"Food",65994,"Ongoing","Terri Lynn Inc.","Elgin","IL","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","US: Nationwide (AK, CT, FL, GA, IA, IL, IN, KS, MD, MI, MT, NC, NJ, NV, OH, PA, WI, WV)","F-0218-2014","Class I","Mixed nuts in a plastic bag labeled in part: Deluxe Mixed Nuts with Macadamia; NET WT. 12 OZ. (340 g), 30 LB, 35 LB; P.O. BOX 5118 ELGIN, IL 60121","12-oz.: Item Number: 09720; Best Buy Date: 12-29-14; Lot Number: MO-0551140; 30-lb: Item Number: 20062; Julian Code: 3203; Lot Number: MO-00554485; 35-lb: Item Number: 96004; Lot Number: MO-00550823",,"12-oz.: 56 bags (7 cases); 30-lb: 5 cases; and 35-lb.: 51.24 cases","Terri Lynn Inc. ''Deluxe Mixed Nuts No Peanuts'' was found to have undeclared peanuts inside the bag. ",8/12/2013,"08/12/2013",11/27/2013,"11/27/2013"
"Devices",65995,"Ongoing","Megadyne Medical Products, Inc.","Draper","UT","US","Voluntary: Firm Initiated","Letter","Class II Recall - Worldwide Distribution - US including the states of CA, HI, IL, MN, NC, NJ, OH, PA, TX, UT and VA.","Z-2097-2013","Class II","E-Z Clean Disposable Laparoscopic Electrode Model Number 0100L and 0100LS. Expiration dates of 05/2018 to 07/2018. Sterile. RX ONLY. This product is packaged individually in a chevron Tyvek - polyester peel pouch, 6 pouches per box. The E-Z Clean laparoscopic electrode is intended to conduct monopolar electrosurgical energy from an electrosurgical generator to target tissue during laparoscopic surgical procedures. This device is intended to be used whenever monopolar electrosurgical cutting and coagulation are indicated.","Model: 0100L, Lots: 131508, 131945, 132167, 132396 Model: 0100LS, Lots: 131509, 131946, 132058 ",,"1816","Megadyne Medical Products is recalling certain lots of E-Z Clean, L-Wire laproscopic Electrode Standard Stem and Split Stem due to potential breach of insulation.",8/7/2013,"08/07/2013",9/4/2013,"09/04/2013"
"Devices",65996,"Ongoing","Elekta, Inc.","Atlanta","GA","US","Voluntary: Firm Initiated","Letter","Nationwide Distribution including AK, CA, CO, CT, FL, IL, IN, MI, MN, MO, NC, NJ, NY, OH, OK, OR, PA, SC, TN, TX, WA and Puerto Rico.","Z-2276-2013","Class II","Monaco RTP System Radiation treatment planning","Versions 3.10.00 and later",".","45","Upgrade installation script is designed to overwrite the same pouch files in the Treatment Couch Library with the original default values.",7/2/2013,"07/02/2013",10/2/2013,"10/02/2013"
"Devices",65997,"Ongoing","Synthes USA HQ, Inc.","West Chester","PA","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution - US (nationwide) and country of Mexico","Z-0114-2014","Class II","Synthes Application Instrument Sternal Zip Flex System intended for use in primary or secondary closure/repair of the sternum following sternotomy or fracture of the sternum to stabilize the sternum and promote fusion","Part No.: 03.501.080 with multiple lot numbers: 3783492 3783913 3788496 3822332 7516728 7606881 7635218 7653178 7659168 7666085 7671934 7679825 7689244 7694377 7700691 7705157 7720599 7738572 7738573 7740498 7742713 7767497 7797648 7803768 7806881 7818677 7818682 7821672 7827088 7831855 7833606 7858407 8068078 ",,"319","When using the 1st generation Zip Fix Application Instrument it is possible to cut the implant while the tensioning trigger is being squeezed which could lead to loosening of the implant.",8/13/2013,"08/13/2013",11/6/2013,"11/06/2013"
"Devices",65998,"Ongoing","Elekta, Inc.","Atlanta","GA","US","Voluntary: Firm Initiated","Letter","Distributed in Puerto Rico and the states of AK, AZ, CA, CO, CT, FL, IL, IN, MA, MD, MI, MN, MO, NC, NJ, NM, NY, OH, OK, OR, PA, RI, SC, TN, TX, VA, and WA.","Z-2277-2013","Class II","Monaco RTP System Radiation Therapy Treatment Planning System. Radiation treatment planning.","All versions of Monaco",".","72","Patient needs to be positioned as indicated by the treatment plan.",5/22/2013,"05/22/2013",10/2/2013,"10/02/2013"
"Devices",65999,"Completed","Spine Smith Holdings, LLC","Austin","TX","US","Voluntary: Firm Initiated","Other","Distributed in FL.","Z-2258-2013","Class II","VisuALIF,System consisting of a 'U' shaped PEEK block in two footprint configurations, four heights and three lordosis angles., part number: 0301-1410. Intended to be implanted via an open anterior approach. ","Part Number: 0301-1410, Lot 53AR",,"32","The product has the potential to be laser marked as a Medium when it actually is a Small.",7/31/2013,"07/31/2013",9/25/2013,"09/25/2013"
"Devices",66000,"Ongoing","Getinge Disinfection","Vaxjo",,"SE","Voluntary: Firm Initiated","Letter","USA Nationwide in the states of AL, AR, AZ, CA, CO, FL, GA, HI, IA, ID, IL, IN, KS, LA, MA, MD, MI, MN, MO, MS, NC, NE, NH, NJ, NM, NV, NY, OH, OK, PA, PR, SC, SD, TN, TX, UT, VA, WA, WI, WV, WY and internationally in Canada.","Z-0018-2014","Class II","Getinge 46-Series Medical Washer-Disinfectors, Listing # E208196 Product Usage: The washer disinfector is used in healthcare facilities where reusable items such as instruments, utensils, anesthesia sets, and glassware are handled for decontamination purposes.","Model # 46-4, Serial # range SEV0521184-SEV0838137 ",,"143 units (142 domestically & 1 unit internationally)","Getinge Disinfection AB initiated a voluntary field safety correction for the Getinge 46-Series electrically-heated Washer Disinfectors due to possible overheating.",7/30/2013,"07/30/2013",10/23/2013,"10/23/2013"
"Food",66001,"Terminated","Whole Foods Market","Emeryville","CA","US","Voluntary: Firm Initiated","E-Mail","Northern CA and one location in NV","F-1857-2013","Class I","Blueberry Crostata, 1 pie Net. Wt. 1 lb. 6 oz (624 g) UPC: 0216733009993 Whole Foods Market Inc., Emeryville, CA 94608","All units with sell by date prior to 8/14/13 and pack date prior to 8/10/13.",,"~110-120 units per week. 19 weeks of product - 2280 total units","Egg wash is used on the product and is not listed on the ingredient list or allergen statement.",8/10/2013,"08/10/2013",9/4/2013,"09/04/2013"
"Food",66001,"Terminated","Whole Foods Market","Emeryville","CA","US","Voluntary: Firm Initiated","E-Mail","Northern CA and one location in NV","F-1856-2013","Class I","Sour Cherry Crostata, 1 pie Net. Wt. 1 lb. 6 oz (624 g) Whole Foods Market Inc., Emeryville, CA 94608","All units with sell by date prior to 8/14/13 and pack date prior to 8/10/13.",,"~110-120 units a week, both varieties. 19 weeks of production for ~2280 individual crostatas.","Egg wash is used on the product and is not listed on the ingredient list or allergen statement.",8/10/2013,"08/10/2013",9/4/2013,"09/04/2013"
"Food",66002,"Ongoing","Global Juices & Fruits LLC","Eagle","ID","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","MA & NY","F-1860-2013","Class III","Nature's Earthly Choice Organic Quinoa Distributed by Nature's Earthly Choice Eagle, ID 83616 Product of Bolivia a) Net Wt 2 lbs. - UPC 897034002267 b) Net Wt 4 lbs.- UPC 897034002021 packaged in re-sealable bags","a) Net wt 32 oz - UPC 897034002267 Item no. G511002267 Best Buy Date 2/11/14, 02/12/14, 02/13/14, 02/14/14 b) Net wt 4 lbs - UPC 897034002021 Item no. G5914202 - Best Buy Date 02/02/14 ",,"2 lbs.- 26,112 bags; 4 lbs.. - 1,500 bags","Nature's Earthly Choice Organic Quinoa may contain sand and grit.",4/26/2013,"04/26/2013",9/4/2013,"09/04/2013"
"Food",66003,"Ongoing","Thrive Foods LLC","American Fork","UT","US","Voluntary: Firm Initiated","Visit","The product was distributed nationwide, in all U.S. states, and in Canada (Wade & Sandy Pierson Company Name: In Case Of , #102 127 Commercial Drive , Calgary AB T3Z 2A7 Canada, Tel. 403-381-0005). The product was not distributed to the U.S. Defense Supply Center, VA or other Federal Government Agency Sales/distribution center.","F-1867-2013","Class III","THRIVE 6 Grain Pancake Mix; There are two unit sizes: (1) 4 lb. #10/gallon can (6.03x 7.02) (the ''Gallon Cans''); and (2) 1.17 lb. Pull-Top Pantry Cans (4.01x 5.08) (the ''Pantry Cans''). Both units are packaged in metal cans. The Pantry Can has a metal pull-top lid and the Gallon Can has a metal lid that must be opened by a can opener. (1) The Gallon Cans may be ordered as single units or in six (6) can cases. (2) The Pantry Cans may be ordered as single units or in ten (10) can cases. ","Catalog numbers: (1) Gallon Cans - 21110; (2) Pantry Cans - 22110 Website ID numbers: (1) Gallon Cans - 660 (2) Pantry Cans - 584 Identified using Canning dates: 2009 - 07/15/09, 08/25/09, 09/25/09, 11/23/09, 12/15/09; 2010 - 02/13/10, 03/04/10, 03/10/10, 03/11/10, 04/06/10, 04/12/10, 04/23/10, 04/24/10, 05/10/10, 06/16/10, 06/17/10, 06/30/10, 07/14/10, 08/26/10, 08/27/10, 08/30/10, 08/31/10, 09/20/10, 09/27/10, 09/28/10, 10/07/10, 10/08/10, 10/19/10, 10/20/10, 10/23/10, 10/30/10, 11/10/10, 11/29/10, 12/03/10, 12/14/10, 12/28/10; 2011 - 01/03/11, 01/04/11, 01/13/11, 03/21/11, 05/06/11, 05/23/11, 06/15/11, 06/16/11, 06/26/11, 07/20/11, 07/25/11, 10/17/11, 10/18/11, 10/31/11, 11/16/11, 11/21/11, 11/30/11, 12/15/11, 12/21/11, 12/29/11; 2012 - 01/13/12, 01/25/12, 02/06/12, 02/07/12, 02/13/12, 03/15/12, 03/26/12, 04/16/12",".","Gallon Cans - 100,116 cans; Pantry Cans - 4,219 cans ","Thrive Foods is recalling certain lots of its 64 and 72 ounce cans of THRIVE 6 Grain Pancake Mix because this product contains ingredients that react over time and increase the pressure inside the can, which may cause cans to expand or bulge and increase the risk of sudden release of the pancake mix when the can is opened and could pose the risk of injury.",7/25/2013,"07/25/2013",9/11/2013,"09/11/2013"
"Food",66005,"Ongoing","Tasty Bake Inc","Baker City","OR","US","Voluntary: Firm Initiated","E-Mail","distributed in Idaho, Oregon and Washington.","F-1884-2013","Class II","Frozen dough balls are sold under brand name Winco or Tasty Bake: Item # 04018 is 17 oz wheat dough ball, Winco brand, individually wrapped in plastic bag with label for retail use, UPC 0 31693 04018 9; Item # 00518 is 17 oz white dough ball, Winco brand, individually wrapped in plastic bag with label for retail use, UPC 0 31693 00518 8; Item # 00520 is Tasty Bake original 20 oz dough ball, BULK packed with 30 individual plastic bags per case for food service use,UPC 0 31693 00520 1; Item # 00525 is Tasty Bake original 25 oz dough ball, BULK packed with 24 individual plastic bags per case for food service use, UPC 0 31693 00525 6; Item # 00530 is Tasty Bake original 30 oz dough ball, BULK packed with 20 individual plastic bags per case for food service use,UPC 0 31693 00530 0. The Winco's label is read in parts: ''***Pizza Dough***Roll out crust to desired size***Top with favorite toppings***Baked at 400F for 15 to 20 minutes or until golden brown***''. The Cooking instructions is labeled in parts: ''***CRUST & DOUGH HANDLING***DOUGH BALLS***Cooking Guidelines for Dough Balls***Deck***Oven Temp 450-475F***Cook time 12-18 minutes****Conveyor***Oven Temp 500F***Cook time 5-9 minutes***Convection***Oven Temp 400-425F***Cook time 7-12 minutes***Tasty Bake, Inc.***1945 8th Street***Baker City, OR 97814***(800) 753-2112***(541) 523-5323***Fax: (541) 523-4764***","Julian Dates 213-220 It interprets that product was made on August 1 through August 8.",,"490 cases total","Frozen dough ball was processed with Baker City (Oregon) water and it has a potential to be contaminated with Cryptosporidium. The Boil Water Notice was issued on 7/31/13 by Baker County and Baker City officials in Oregon",8/8/2013,"08/08/2013",9/25/2013,"09/25/2013"
"Biologics",66006,"Terminated","Central Pennsylvania Blood Bank","Hummelstown","PA","US","Voluntary: Firm Initiated","Other","PA","B-2561-13","Class III","Fresh Frozen Plasma","W270113503891",,"1 unit","Blood products, collected from a donor who previously tested positive for NAT, were distributed.",7/11/2013,"07/11/2013",11/27/2013,"11/27/2013"
"Biologics",66006,"Terminated","Central Pennsylvania Blood Bank","Hummelstown","PA","US","Voluntary: Firm Initiated","Other","PA","B-2560-13","Class III","Red Blood Cells Leukocytes Reduced","W270113503891",,"1 unit","Blood products, collected from a donor who previously tested positive for NAT, were distributed.",7/11/2013,"07/11/2013",11/27/2013,"11/27/2013"
"Biologics",66007,"Terminated","Innovative Blood Resources","Saint Paul","MN","US","Voluntary: Firm Initiated","FAX","NJ","B-2459-13","Class II","Platelets Pheresis Leukocytes Reduced","W051513080504",,"1 unit","Platelet, with insufficient plasma volume to support the platelet yield, was distributed.",7/9/2013,"07/09/2013",11/27/2013,"11/27/2013"
"Biologics",66008,"Terminated","OneBlood, Inc.","Lantana","FL","US","Voluntary: Firm Initiated","Telephone","FL","B-2513-13","Class II","Fresh Frozen Plasma","1683440",,"1 unit","Blood products, collected from a donor for whom donor suitability was not adequately determined, were distributed.",7/9/2013,"07/09/2013",11/27/2013,"11/27/2013"
"Biologics",66008,"Terminated","OneBlood, Inc.","Lantana","FL","US","Voluntary: Firm Initiated","Telephone","FL","B-2514-13","Class II","Red Blood Cells (Apheresis) Leukocytes Reduced","2129638; 2129638; 2453096; 2453096",,"4 units","Blood products, collected from a donor for whom donor suitability was not adequately determined, were distributed.",7/9/2013,"07/09/2013",11/27/2013,"11/27/2013"
"Biologics",66008,"Terminated","OneBlood, Inc.","Lantana","FL","US","Voluntary: Firm Initiated","Telephone","FL","B-2512-13","Class II","Red Blood Cells","1683440",,"1 unit","Blood products, collected from a donor for whom donor suitability was not adequately determined, were distributed.",7/9/2013,"07/09/2013",11/27/2013,"11/27/2013"
"Devices",66010,"Ongoing","Medtronic Sofamor Danek USA Inc","Memphis","TN","US","Voluntary: Firm Initiated","Letter","USA Nationwide Distribution in the state of GA, AK, WA, and CA.","Z-2200-2013","Class II","T8 REMOVAL HEAD, REF 8910641, QTY: 1 EA, Product Usage: The non-sterile T8 Removal Diriver is used with the Spire and Spire Z Spinal System in conjunction with the set screwdriver to remove the implant during removal surgery. The set screw driver is attached to the end of the removal head and used to disengage the remaining portion of the set screw within the device. ","RS12K008",,"9 units ","One lot of the T8 Removal Head had incorrect hardness specification, which could result in the T8 Removal head failing during removal of the CD Horizon Spire and Spire Z Spinal System implant. There is a potential for tissue damage to occur and/or minor surgical delay to remove the remaining fragments of the tip.",8/12/2013,"08/12/2013",9/25/2013,"09/25/2013"
"Food",66011,"Ongoing","Justin'S Nut Butter","Boulder","CO","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Nationwide. No foreign, military, gov't, VA distribution.","F-1875-2013","Class III","Chocolate Hazelnut Butter 16oz Jar (Unit UPC 894455000490, Case UPC 894455000612)","Lot Code 191 (Best By Date 07/10/14) Lot Code 192 (Best By Date 07/11/14) ",".","1,512 master cases (6 jars per master case) ","Justin's has initiated a voluntary recall of certain lots of its Maple Almond Butter 16oz jars and its Chocolate Hazelnut Butter 16oz jars due to the presence of foreign metallic fragments in unpackaged nut butter. ",8/16/2013,"08/16/2013",9/11/2013,"09/11/2013"
"Food",66011,"Ongoing","Justin'S Nut Butter","Boulder","CO","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Nationwide. No foreign, military, gov't, VA distribution.","F-1874-2013","Class III","Maple Almond Butter 16 oz Jar (Unit USPC 894455000322, Case USPC 894455002135) ","Lot Code 188 (Best By Date 07/07/14) Lot Code 190 (Best By Date 07/09/14) Lot Code 191 (Best By Date 07/10/14) ",".","5,649 master cases (6 jars per master case)","Justi's has initiated a voluntary recall of certain lots of its Maple Almond Butter 16oz jars and its Chocolate Hazelnut Butter 16oz jars due to the presence of foreign metallic fragments in unpackaged nut butter. ",8/16/2013,"08/16/2013",9/11/2013,"09/11/2013"
"Drugs",66012,"Ongoing","Cetylite Industries, Inc.","Pennsauken","NJ","US","Voluntary: Firm Initiated","Letter","Nationwide","D-019-2014","Class II","Cetacaine Liquid Topical Anesthetic, Rx Only, a) 14 g bottle (NDC 10223-0202-2); Kit w/14 g (NDC 10223-0202-3); 30 g bottle (NDC 10223-0202-4) Manufactured by Cetylite Industries, Inc., 9051 River Road Pennsauken, NJ 08110 -","Lot 470 exp. 04/13, 471 exp. 06/13, 472 exp. 10/13 ",".","30 g - 11403 bottles; 14 g - 7338 bottles 14 g kit - 200 kits","Subpotent Drug: Cetacaine Topical Anesthetic Liquid is being recalled because one of the three active ingredients, tetracaine, is below the specification limit at the 21 month stability test point. ",4/2/2013,"04/02/2013",12/4/2013,"12/04/2013"
"Food",66013,"Ongoing","Novartis Consumer Health","Lincoln","NE","US","Voluntary: Firm Initiated","Letter","Distribution was made nationwide.","F-1903-2013","Class III","Benefiber, Fiber plus Calcium Supplement, Wild Berry Chewables 90ct, sugar free, chewable tablets bottle. Novartis Consumer Health, Inc, Parsippany, NJ.","Lot Number and Expiration date 10118852 , 6/30/2013; 10123090, 8/31/2013; 10127095, 10/31/2014. ",," 26,604 units","The lot number and/or expiration date may be illegible on the outer plastic bottle packaging.",8/6/2013,"08/06/2013",9/25/2013,"09/25/2013"
"Food",66013,"Ongoing","Novartis Consumer Health","Lincoln","NE","US","Voluntary: Firm Initiated","Letter","Distribution was made nationwide.","F-1904-2013","Class III","Benefiber, Fiber Supplement, Orange Creme Chewables, Sugar Free, 36ct and 100ct chewable tablet bottles. Novartis Consumer Health, Inc, Parsippany, NJ.","Lot Number and Expiration date (36ct bottle): 10117915, 5/31/2014; 10118335, 7/31/2014; 10120615, 9/30/2014; 10110703A 3/31/2014. (100ct bottle): 10110706, 2/28/2014; 10112140, 2/28/2014; 10113261, 5/31/2014; 10116530, 5/31/2014; 10120059, 7/31/2014; 10120616, 8/31/2014; 10125996, 9/30/2014 and 10109551, 3/31/2015.",,"165,480 units","The lot number and/or expiration date may be illegible on the outer plastic bottle packaging.",8/6/2013,"08/06/2013",9/25/2013,"09/25/2013"
"Food",66013,"Ongoing","Novartis Consumer Health","Lincoln","NE","US","Voluntary: Firm Initiated","Letter","Distribution was made nationwide.","F-1906-2013","Class III","Benefiber, Fiber Supplement, Assorted Fruit, Sugar Free, 100ct chewable tablets. Novartis Consumer Health, Inc, Parsippany, NJ.","Lot Number and Expiration date 10110708, 5/12/2011; 10110806, 5/10/2011; 10111858, 6/8/2011; 10112132, 6/17/2011; 10113256, 7/25/2011; 10116303, 9/9/2011; 10116444, 9/8/2011; 10118336, 10/6/2011; 10118337, 10/6/2011; 10119374, 10/31/2011; 10119376, 10/4/2011; 10120002, 12/6/2011; 10120003, 11/1/2011; 10123092, 12/6/2011; 10123093, 11/18/2011; 10125929, 12/21/2011; 10125995, 12/21/2011; ",,"419,040 units","The lot number and/or expiration date may be illegible on the outer plastic bottle packaging.",8/6/2013,"08/06/2013",9/25/2013,"09/25/2013"
"Food",66013,"Ongoing","Novartis Consumer Health","Lincoln","NE","US","Voluntary: Firm Initiated","Letter","Distribution was made nationwide.","F-1905-2013","Class III","Benefiber, Fiber Supplement, 72ct and 114 caplet bottles. Novartis Consumer Health, Inc, Parsippany, NJ.","Lot Number and Expiration date 72 ct bottle: 10100086, 9/30/2013 114 ct bottle: 10093114, 6/30/2013; 10095522, 7/31/2013; 10095531, 7/31/2013; 10097337, 8/31/2013; 10099444, 9/30/2013; 10099445, 9/30/2013; 10101260, 10/31/2013; 10102755, 11/30/2013; 10104634, 12/31/2013; 10104635, 1/31/2014; 10108857, 1/31/2014; 10112134, 2/28/2014; 10112135, 4/30/2014; 10113255, 5/31/2014; 10116304, 5/31/2014; 10118831, 6/30/2014; 10119626, 6/30/2014; 10120461, 7/31/2014; 10120462, 7/31/2014; 10124311, 9/30/2014; 10128842, 10/31/2014.",,"504,456 units","The lot number and/or expiration date may be illegible on the outer plastic bottle packaging.",8/6/2013,"08/06/2013",9/25/2013,"09/25/2013"
"Food",66013,"Ongoing","Novartis Consumer Health","Lincoln","NE","US","Voluntary: Firm Initiated","Letter","Distribution was made nationwide.","F-1907-2013","Class III","Benefibre, Orange Creme Chewables, 36ct and 100ct chewable tablet bottles. Foreign labeling: Novartis Consumer Health Canada Inc, Mississauga, ON.","Lot Number and Expiration date 36ct bottle: 10101294, 12/31/2013; 10114155, 4/30/2014 100ct bottle: 10097346,8/31/2013;10104669,12/31/2013;10117018,1/31/2014;10117019,4/30/2014;10120625,8/31/2014;",,"70,380 units","The lot number and/or expiration date may be illegible on the outer plastic bottle packaging.",8/6/2013,"08/06/2013",9/25/2013,"09/25/2013"
"Drugs",66014,"Ongoing","Amneal Pharmaceuticals of New York, LLC.","Hauppauge","NY","US","Voluntary: Firm Initiated","Letter","IL, NH, NJ, NY, OH, RI, TN","D-66014-001","Class II","Extended Phenytoin Sodium Capsules, USP, 100 mg, 1000 CAPSULES, Rx only, amneal PHARMACEUTICALS label, NDC 65162-212-11 --- Manufactured by: Amneal Pharmaceuticals of NY Hauppauge, NY 11788 Distributed by: Amneal Pharmaceuticals Glasgow, KY 42141 ","Batch/Lot HL50611, exp. 1/2014",".","895 - 1000 count bottles ","Failed dissolution specifications; 18 month CRT",8/17/2013,"08/17/2013",11/13/2013,"11/13/2013"
"Drugs",66015,"Ongoing","Novartis Pharmaceuticals Corp.","Suffern","NY","US","Voluntary: Firm Initiated","Letter","Nationwide and Puerto Rico","D-334-2014","Class II","Exforge (amlodipine and valsartan, Tablets) 10/320 mg, Rx only, 7 tablets per bottle, Physician Sample - Not For Sale. Manufactured by: Novartis Pharma Stein AG Stein, Switzerland. Distributed by: Novartis Pharmaceuticals Corp. East Hanover, New Jersey 07936, NDC # 0078-9491-07","Product code: 710007 & 725277; Lot Number: F0131, Exp 11/30/2013; F0138, Exp 01/31/2014; F0137, F0139, F0140, F0141, F0142, F0142A, Exp 02/28/2014; F0145, F0150, F0157, F0158, Exp 04/30/2014; F0159, F0160, Exp 05/31/2014; F0163, F0165, Exp 07/31/2014; F0184, Exp 01/31/2015",,"951,109 bottles ","Chemical Contamination: Novartis Pharmaceuticals Corporation has recalled physician sample bottles of Diovan, Exforge, Exforge HCT,Lescol XL, Stalevo, Tekturna and Tekturna HCT Tablets due to contamination with Darocur 1173 a photocuring agent used in inks on shrink-wrap sleeves.",8/8/2013,"08/08/2013",12/18/2013,"12/18/2013"
"Drugs",66015,"Ongoing","Novartis Pharmaceuticals Corp.","Suffern","NY","US","Voluntary: Firm Initiated","Letter","Nationwide and Puerto Rico","D-332-2014","Class II","Exforge HCT (amlodipine, valsartan, hydrochlorothiazide) 5/160/25 mg, Rx only, 7 tablets per bottle, Physician Sample - Not For Sale. Manufactured by: Novartis Pharma Stein AG Stein, Switzerland. Distributed by: Novartis Pharmaceuticals Corp. East Hanover, New Jersey 07936, NDC # 0078-9560-89","Product code: 715515; Lot Number: F0012, Exp 10/31/2013; F0013, Exp 02/28/2014; F0014, Exp 03/31/2014 ",,"174,848 bottles","Chemical Contamination: Novartis Pharmaceuticals Corporation has recalled physician sample bottles of Diovan, Exforge, Exforge HCT,Lescol XL, Stalevo, Tekturna and Tekturna HCT Tablets due to contamination with Darocur 1173 a photocuring agent used in inks on shrink-wrap sleeves.",8/8/2013,"08/08/2013",12/18/2013,"12/18/2013"
"Drugs",66015,"Ongoing","Novartis Pharmaceuticals Corp.","Suffern","NY","US","Voluntary: Firm Initiated","Letter","Nationwide and Puerto Rico","D-339-2014","Class II","Tekturna HCT (aliskiren and hydrochlorothiazide) Tablets 150/12.5 mg, 7 tablets per bottle, Physician Sample-Not For Sale, Rx only, Manufactured by: Novartis Pharma Productions GmbH Wehr, Germany. Distributed by: Novartis Pharmaceuticals Corp. East Hanover, New Jersey 07936 , NDC # 0078-9521-89","Product code: 712396; Lot Number: F0026, F0027; Exp 07/31/2014",,"16,693 bottles","Chemical Contamination: Novartis Pharmaceuticals Corporation has recalled physician sample bottles of Diovan, Exforge, Exforge HCT,Lescol XL, Stalevo, Tekturna and Tekturna HCT Tablets due to contamination with Darocur 1173 a photo curing agent used in inks on shrink-wrap sleeves.",8/8/2013,"08/08/2013",12/18/2013,"12/18/2013"
"Drugs",66015,"Ongoing","Novartis Pharmaceuticals Corp.","Suffern","NY","US","Voluntary: Firm Initiated","Letter","Nationwide and Puerto Rico","D-336-2014","Class II","Stalevo (carbidopa, levodopa, and entacapone) 12.5/50/200 mg, 7 tablets per bottle, Physician Sample-Not For Sale, Rx only, Manufactured by: Novartis Pharma Productions GmbH Wehr, Germany. Distributed by: Novartis Pharmaceuticals Corp. East Hanover, New Jersey 07936, NDC # 0078-9407-01","Product code: 707156; Lot Number: F0012, Exp 02/28/2014",,"18,665 bottles","Chemical Contamination: Novartis Pharmaceuticals Corporation has recalled physician sample bottles of Diovan, Exforge, Exforge HCT,Lescol XL, Stalevo, Tekturna and Tekturna HCT Tablets due to contamination with Darocur 1173 a photocuring agent used in inks on shrink-wrap sleeves.",8/8/2013,"08/08/2013",12/18/2013,"12/18/2013"
"Drugs",66015,"Ongoing","Novartis Pharmaceuticals Corp.","Suffern","NY","US","Voluntary: Firm Initiated","Letter","Nationwide and Puerto Rico","D-326-2014","Class II","Diovan (valsartan) 160 mg per tablet, 7 Tablets per bottle, Rx only Physician Sample Not For Sale, Manufactured by: Novartis Pharmaceuticals Corporation Suffern, NY 10901 for Novartis Pharmaceuticals Corporation East Hanover, NJ 07936, NDC # 0078-9359-07","Product code: 704412; Lot Number: F1186, Exp 03/31/2014; F1127, F1127A, Exp 07/31/2014",,"139,788 bottles","Chemical Contamination: Novartis Pharmaceuticals Corporation has recalled physician sample bottles of Diovan, Exforge, Exforge HCT,Lescol XL, Stalevo, Tekturna and Tekturna HCT Tablets due to contamination with Darocur 1173 a photocuring agent used in inks on shrink-wrap sleeves.",8/8/2013,"08/08/2013",12/18/2013,"12/18/2013"
"Drugs",66015,"Ongoing","Novartis Pharmaceuticals Corp.","Suffern","NY","US","Voluntary: Firm Initiated","Letter","Nationwide and Puerto Rico","D-327-2014","Class II","Diovan (valsartan) 320 mg per tablet, 7 Tablets per bottle, Rx only Physician Sample Not For Sale, Manufactured by: Novartis Pharmaceuticals Corporation Suffern, NY 10901 for Novartis Pharmaceuticals Corporation East Hanover, NJ 07936, NDC # 0078-9360-07","Product code: 704414; Lot Number: F1027; Exp 2/28/2014",,"57,881 bottles","Chemical Contamination: Novartis Pharmaceuticals Corporation has recalled physician sample bottles of Diovan, Exforge, Exforge HCT,Lescol XL, Stalevo, Tekturna and Tekturna HCT Tablets due to contamination with Darocur 1173 a photocuring agent used in inks on shrink-wrap sleeves.",8/8/2013,"08/08/2013",12/18/2013,"12/18/2013"
"Drugs",66015,"Ongoing","Novartis Pharmaceuticals Corp.","Suffern","NY","US","Voluntary: Firm Initiated","Letter","Nationwide and Puerto Rico","D-335-2014","Class II","Lescol XL (fluvastatin sodium) Extended-Release Tablets, 80 mg per tablet, 7 tablets per bottle, Physician Sample-Not For Sale, Rx only. Manufactured by: Novartis Pharma Stein AG Stein, Switzerland. Distributed by: Novartis Pharmaceuticals Corp. East Hanover, New Jersey 07936, NDC # 0078-9354-07","Product code: 707136; Lot Number: F0017, Exp 01/31/2015 ",,"46,812 bottles","Chemical Contamination: Novartis Pharmaceuticals Corporation has recalled physician sample bottles of Diovan, Exforge, Exforge HCT,Lescol XL, Stalevo, Tekturna and Tekturna HCT Tablets due to contamination with Darocur 1173 a photocuring agent used in inks on shrink-wrap sleeves.",8/8/2013,"08/08/2013",12/18/2013,"12/18/2013"
"Drugs",66015,"Ongoing","Novartis Pharmaceuticals Corp.","Suffern","NY","US","Voluntary: Firm Initiated","Letter","Nationwide and Puerto Rico","D-331-2014","Class II","Exforge HCT (amlodipine, valsartan, hydrochlorothiazide) 5/160/12.5 mg, Rx only, 7 tablets per bottle, Physician Sample - Not For Sale. Manufactured by: Novartis Pharma Stein AG Stein, Switzerland. Distributed by: Novartis Pharmaceuticals Corp. East Hanover, New Jersey 07936, NDC # 0078-9559-89 ","Product code: 715523 & 725278; Lot Number: F0019, F0019A, Exp 08/31/2013; F0020, Exp 09/30/2013; F0021, F0021A, Exp 10/31/2013; F0022, F0025, Exp 11/30/2013; F0024, F0026, Exp 12/31/2013; F0027, Exp 09/30/2014",,"328,543 bottles","Chemical Contamination: Novartis Pharmaceuticals Corporation has recalled physician sample bottles of Diovan, Exforge, Exforge HCT,Lescol XL, Stalevo, Tekturna and Tekturna HCT Tablets due to contamination with Darocur 1173 a photocuring agent used in inks on shrink-wrap sleeves.",8/8/2013,"08/08/2013",12/18/2013,"12/18/2013"
"Drugs",66015,"Ongoing","Novartis Pharmaceuticals Corp.","Suffern","NY","US","Voluntary: Firm Initiated","Letter","Nationwide and Puerto Rico","D-329-2014","Class II","Exforge (amlodipine and valsartan Tablets) 5/320 mg, Rx only 7 tablets per bottle, Physician Sample - Not For Sale. Manufactured by: Novartis Pharma Stein AG Stein, Switzerland. Distributed by: Novartis Pharmaceuticals Corp. East Hanover, New Jersey 07936 - NDC # 0078-9490-07","Product code: 710003; Lot Number: F0102, Exp 11/30/2013; F0115, F0116, Exp 01/31/2014; F0105, F0109, F0111, F0112, Exp 02/28/2014; F0121, F0122, Exp 05/31/2014; F0125A, F0125W1, Exp 07/31/2014; F0137, F0139, F0140, F0141, F0142, F0144; Exp 11/30/2014",,"869,951 bottles","Chemical Contamination: Novartis Pharmaceuticals Corporation has recalled physician sample bottles of Diovan, Exforge, Exforge HCT,Lescol XL, Stalevo, Tekturna and Tekturna HCT Tablets due to contamination with Darocur 1173 a photocuring agent used in inks on shrink-wrap sleeves.",8/8/2013,"08/08/2013",12/18/2013,"12/18/2013"
"Drugs",66015,"Ongoing","Novartis Pharmaceuticals Corp.","Suffern","NY","US","Voluntary: Firm Initiated","Letter","Nationwide and Puerto Rico","D-333-2014","Class II","Exforge (amlodipine and valsartan Tablets) 10/160 mg, Rx only, 7 tablets per bottle, Physician Sample - Not For Sale. Manufactured by: Novartis Pharma Stein AG Stein, Switzerland. Distributed by: Novartis Pharmaceuticals Corp. East Hanover, New Jersey 07936, NDC # 0078-9489-07","Product code: 710011; Lot Number: F0060, Exp 01/31/2014; F0028A, Exp 02/28/2014; F0061, Exp 03/31/2014; F0062, Exp 05/31/2014; F0033A, Exp 10/31/2014; F0037A, Exp 01/31/2015 ",,"61,1240 bottles","Chemical Contamination: Novartis Pharmaceuticals Corporation has recalled physician sample bottles of Diovan, Exforge, Exforge HCT,Lescol XL, Stalevo, Tekturna and Tekturna HCT Tablets due to contamination with Darocur 1173 a photocuring agent used in inks on shrink-wrap sleeves.",8/8/2013,"08/08/2013",12/18/2013,"12/18/2013"
"Drugs",66015,"Ongoing","Novartis Pharmaceuticals Corp.","Suffern","NY","US","Voluntary: Firm Initiated","Letter","Nationwide and Puerto Rico","D-340-2014","Class II","Tekturna HCT (aliskiren and hydrochlorothiazide) Tablets 300/25 mg, 7 tablets per bottle, Physician Sample-Not For Sale, Rx only, Manufactured by: Novartis Pharma Productions GmbH Wehr, Germany. Distributed by: Novartis Pharmaceuticals Corp. East Hanover, New Jersey 07936, NDC # 0078-9524-89","Product code: 712427; Lot Number: F0036, F0036W1, Exp 08/31/2013; F0038, Exp 06/30/2014; F0039, Exp 08/31/2014.",,"70,006 bottles","Chemical Contamination: Novartis Pharmaceuticals Corporation has recalled physician sample bottles of Diovan, Exforge, Exforge HCT,Lescol XL, Stalevo, Tekturna and Tekturna HCT Tablets due to contamination with Darocur 1173 a photo curing agent used in inks on shrink-wrap sleeves.",8/8/2013,"08/08/2013",12/18/2013,"12/18/2013"
"Drugs",66015,"Ongoing","Novartis Pharmaceuticals Corp.","Suffern","NY","US","Voluntary: Firm Initiated","Letter","Nationwide and Puerto Rico","D-337-2014","Class II","Tekturna (aliskiren) Tablets 150 mg, 7 tablets per bottle, Physician Sample-Not For Sale, Rx only. Manufactured by: Novartis Pharma Productions GmbH Wehr, Germany. Distributed by: Novartis Pharmaceuticals Corp. East Hanover, New Jersey 07936, NDC # 0078-9485-07","Product code: 708236; Lot Number: F0116, F0116W1, F0016W2, Exp 09/30/2013; F0117, Exp 02/28/2014; F0118, 6) F0119, Exp 08/31/2014",,"12,6245 bottles","Chemical Contamination: Novartis Pharmaceuticals Corporation has recalled physician sample bottles of Diovan, Exforge, Exforge HCT,Lescol XL, Stalevo, Tekturna and Tekturna HCT Tablets due to contamination with Darocur 1173 a photocuring agent used in inks on shrink-wrap sleeves.",8/8/2013,"08/08/2013",12/18/2013,"12/18/2013"
"Drugs",66015,"Ongoing","Novartis Pharmaceuticals Corp.","Suffern","NY","US","Voluntary: Firm Initiated","Letter","Nationwide and Puerto Rico","D-338-2014","Class II","Tekturna (aliskiren) Tablets 300 mg, 7 tablets per bottle, Physician Sample-Not For Sale, Rx only. Manufactured by: Novartis Pharma Produktions GmbH Wehr, Germany. Distributed by: Novartis Pharmaceuticals Corp. East Hanover, New Jersey 07936, NDC # 0078-9486-07","Product code: 708239; Lot Number: F0140, F0140W1, Exp 09/30/2013; F0142, Exp 07/31/2014; F0143, Exp 08/31/2014; F0144, Exp 10/31/2014; F0145; Exp 01/31/2015.",,"128964 bottles","Chemical Contamination: Novartis Pharmaceuticals Corporation has recalled physician sample bottles of Diovan, Exforge, Exforge HCT,Lescol XL, Stalevo, Tekturna and Tekturna HCT Tablets due to contamination with Darocur 1173 a photocuring agent used in inks on shrink-wrap sleeves.",8/8/2013,"08/08/2013",12/18/2013,"12/18/2013"
"Drugs",66015,"Ongoing","Novartis Pharmaceuticals Corp.","Suffern","NY","US","Voluntary: Firm Initiated","Letter","Nationwide and Puerto Rico","D-330-2014","Class II","Exforge HCT (amlodipine, valsartan, hydrochlorothiazide) 10/320/25 mg, Rx only, 7 tablets per bottle, Physician Sample - Not For Sale. Manufactured by: Novartis Pharma Stein AG Stein, Switzerland. Distributed by: Novartis Pharmaceuticals Corp. East Hanover, New Jersey 07936, NDC # 0078-9563-89","Product code: 715512 & 725276; Lot Number: F0034, Exp 08/31/2013; F0035, F0036, F0036A, Exp 10/31/2013; F0038, F0039, F0040, F0041, F0042, Exp 12/31/2013; F0043, Exp 01/31/2014; F0045, Exp 03/31/2014; F0044, F0046, Exp 04/30/2014 ",,"281,935 bottles","Chemical Contamination: Novartis Pharmaceuticals Corporation has recalled physician sample bottles of Diovan, Exforge, Exforge HCT,Lescol XL, Stalevo, Tekturna and Tekturna HCT Tablets due to contamination with Darocur 1173 a photocuring agent used in inks on shrink-wrap sleeves.",8/8/2013,"08/08/2013",12/18/2013,"12/18/2013"
"Drugs",66015,"Ongoing","Novartis Pharmaceuticals Corp.","Suffern","NY","US","Voluntary: Firm Initiated","Letter","Nationwide and Puerto Rico","D-328-2014","Class II","Exforge (amlodipine and valsartan Tablets) 5/160 mg, Rx only 7 tablets per bottle, Physician Sample - Not For Sale. Manufactured by: Novartis Pharma Stein AG Stein, Switzerland. Distributed by: Novartis Pharmaceuticals Corp. East Hanover, New Jersey 07936 - NDC # 0078-9488-07 ","Product code: 709999 & 725275; Lot Number: F0048A, Exp 08/31/2013; F0056A, Exp 10/31/2013; F0084, F0085, Exp 01/31/2014; F0059A, F0088, Exp 02/28/2014; F0086, F0087, Exp 03/31/2014; F0061A, F0063W1, Exp 05/31/2014; F0070A, Exp 09/30/2014; F0082A, Exp 02/28/2015 ",,"1,492,475 bottles","Chemical Contamination: Novartis Pharmaceuticals Corporation has recalled physician sample bottles of Diovan, Exforge, Exforge HCT,Lescol XL, Stalevo, Tekturna and Tekturna HCT Tablets due to contamination with Darocur 1173 a photocuring agent used in inks on shrink-wrap sleeves.",8/8/2013,"08/08/2013",12/18/2013,"12/18/2013"
"Devices",66016,"Ongoing","GE Healthcare, LLC","Waukesha","WI","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution - USA Nationwide including DC and PR except ND and the countries of: ALGERIA, ANGOLA, ARGENTINA, AUSTRALIA, AUSTRIA, BAHAMAS, BAHRAIN, BANGLADESH, BELARUS, BELGIUM, BOSNIA-HERZEGOVINA, BRAZIL, BULGARIA, CANADA, CHILE, CHINA, COLOMBIA, COSTA RICA, CZECH REPUBLIC, DENMARK, ECUADOR, EGYPT, EL SALVADOR, FINLAND, FRANCE, GERMANY, CHANA, GREECE, HONDURAS, HUNGARY, ICELAND, INDIA, INDONESIA, IRAQ, ISRAEL, ITALY, JAPAN, JORDAN, KAZAKHSTAN, KENYA, KOREA, KUWAIT, LATVIA, LEBANON, LIBYA, LITHUANIA, MACEDONIA, MALAYSIA, MEXICO, MOROCCO, NEPAL, NETHERLANDS, NEW ZEALAND, NIGERIA, NORWAY, PANAMA, PARAGUAY, PERU, POLAND, PORTUGAL, QATAR, ROMANIA, RUSSIA, SAUDI ARABIA, SINGAPORE, SLOVAK IA, SLOVENIA, SOUTH AFRICA, SPAIN, SRI LANKA, SWEDEN, SWITZERLAND, SYRIA, TAIWAN, THAILAND, TUNSIA, TURKEY, UNITED ARAB EMIRATES, UNITED KINGDOM, BOLIVIA, HONG KONG, JAMAICA, PHILIPPINES, SOUTH KOREA, TRINIDAD TOBAGO, URUGUAY, VENEZUELA.","Z-2116-2013","Class II","SOLAR 8000 AND TRANSPORT PRO WITH PATIENT DATA MODULE (Marketed As GE Healthcare CARESCAPE Patient Data Module) Product Usage: The Patient Data Module (PDM) is intended to provide uninterrupted acquisition of physiologic parameter data on adult, pediatric and neonatal patients during non-transport/bedside and transport patient care episodes. ","Mfg Lot or Serial # SA310290653GA SA310290655GA SA310290657GA SA310290659GA SA310290661GA SA310290748GA SA310290749GA SA310290750GA SA310290754GA SA310290755GA SA310290756GA SA310290757GA SA310290758GA SA310290759GA SA310361647GA SA310361877GA SA310372108GA SA310393017GA SA310393052GA SA310382648GA SA310382626GA SA310382631GA SA310382729GA SA310382761GA SA310393037GA SA310393054GA SA310393071GA SA310393073GA SA310351531GA SA310361792GA SA310361798GA SA310361801GA SA310361803GA SA310361804GA SA310361805GA SA310361807GA SA310361808GA SA310361815GA SA310361820GA SA310361838GA SA310361840GA SA310361841GA SA310393150GA SA310393155GA SA310393162GA SA310393165GA SA310393166GA SA310393167GA SA310393170GA SA310393171GA SA310393173GA SA310393175GA SA310321055GA SA310321062GA SA310361949GA SA310382418GA SA310382450GA SA310382499GA SA310382513GA SA310382608GA SA310382647GA SA310382649GA SA310382663GA SA310393156GA SA310393158GA SA310393164GA SA310393169GA SA310393177GA SA310259944GA SA310331337GA SA310331342GA SA310331343GA SA310331345GA SA310331349GA SA310331351GA SA310341373GA SA310341376GA SA310341387GA SA310341388GA SA310341399GA SA310341400GA SA310341401GA SA310341402GA SA310341403GA SA310341406GA SA310382386GA SA310382391GA SA310382472GA SA310382476GA SA310382477GA SA310382479GA SA310382484GA SA310382494GA SA310382618GA SA310382619GA SA310382634GA SA310382636GA SA310382645GA SA310382378GA SA310382449GA SA310382511GA SA310382606GA SA310382607GA SA310382610GA SA310382612GA SA310382613GA SA310382615GA SA310382616GA SA310382642GA SA310382652GA SA310382656GA SA310382664GA SA310423572GA SA310423573GA SA310290745GA SA310290753GA SA310413471GA SA310413476GA SA310423587GA SA310423607GA SA310413493GA SA310413498GA SA310413500GA SA310413507GA SA310413514GA SA310413524GA SA310413535GA SA310423604GA SA310423606GA SA310423611GA SA310423617GA SA310423619GA SA310423621GA SA310423626GA SA310423640GA SA310423649GA SA310423650GA SA310423730GA SA310423821GA SA310423825GA SA310423836GA SA310423838GA SA310423842GA SA310423864GA SA3104239"," SA311060106GA SA311070443GA SA311080671GA SA311080699GA SA311080702GA SA311090776GA SA311090781GA SA311070528GA SA311070534GA SA311070539GA SA311070569GA SA311090822GA SA311090824GA SA311101216GA SA310403374GA SA310423869GA SA310434153GA SA310506762GA SA310507164GA SA310507266GA SA310518181GA SA310528746GA SA311039494GA SA311049577GA SA311059580GA SA311059589GA SA311059600GA SA311060027GA SA311060074GA SA311069627GA SA311069638GA SA311069649GA SA311069658GA SA311069758GA SA311080667GA SA311080668GA SA311080688GA SA311080689GA SA311080692GA SA311090753GA SA311090763GA SA311090790GA SA311090794GA SA311090883GA SA311090885GA SA311101174GA SA311101175GA SA311101179GA SA311101192GA SA311101195GA SA311101198GA SA311101199GA SA311101202GA SA311101203GA SA311101214GA SA311101218GA SA311101236GA SA311101237GA SA311101238GA SA311101239GA SA311101242GA SA311101269GA SA310423723GA SA310496283GA SA310496366GA SA310507015GA SA311090806GA SA310434146GA SA311090986GA SA310506771GA SA311059587GA SA311059602GA SA311060017GA SA311060038GA SA311069625GA SA311069639GA SA311069641GA SA311069648GA SA311069651GA SA311069655GA SA311069656GA SA311069659GA SA311069674GA SA311069678GA SA311069785GA SA311069814GA SA311069820GA SA311069828GA SA311069835GA SA311069841GA SA311070476GA SA311080664GA SA311080665GA SA311080666GA SA311080669GA SA311080680GA SA311080684GA SA311080690GA SA311080698GA SA311080700GA SA311080701GA SA311090895GA SA311090897GA SA311090902GA SA311091009GA SA311091023GA SA311091026GA SA311091030GA SA311091037GA SA311091043GA SA311091045GA SA311091050GA SA311091054GA SA311091055GA SA311091058GA SA311091059GA SA311091060GA SA311101063GA SA311101070GA SA311101083GA SA311101280GA SA311101308GA SA311101319GA SA311101321GA SA311101340GA SA311101351GA SA311101359GA SA311101374GA SA311101376GA SA311101381GA SA310382849GA SA310495916GA SA310506786GA SA311039552GA SA311060008GA SA311060011GA SA311060012GA SA311060013GA SA311069653GA SA311069679GA SA311069692GA SA311069699GA SA311069753GA SA311069755GA SA311069762GA SA311069763GA ","16,462 (8497 US, 7307 OUS, & 658 unlocated)","GE Healthcare has recently become aware of a potential safety issue due to intermittent noise on ECG and/or Respiration waveforms associated with movement of the ECG connector on your DASH, PDM, and/or Tram Module. ECG and Respiration signal noise caused by DASH, PDM, and/or Tram ECG cable connector movement may result in reduced ECG, Respiration and arrhythmia detection performance. ",4/3/2013,"04/03/2013",9/4/2013,"09/04/2013"
"Devices",66016,"Ongoing","GE Healthcare, LLC","Waukesha","WI","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution - USA Nationwide including DC and PR except ND and the countries of: ALGERIA, ANGOLA, ARGENTINA, AUSTRALIA, AUSTRIA, BAHAMAS, BAHRAIN, BANGLADESH, BELARUS, BELGIUM, BOSNIA-HERZEGOVINA, BRAZIL, BULGARIA, CANADA, CHILE, CHINA, COLOMBIA, COSTA RICA, CZECH REPUBLIC, DENMARK, ECUADOR, EGYPT, EL SALVADOR, FINLAND, FRANCE, GERMANY, CHANA, GREECE, HONDURAS, HUNGARY, ICELAND, INDIA, INDONESIA, IRAQ, ISRAEL, ITALY, JAPAN, JORDAN, KAZAKHSTAN, KENYA, KOREA, KUWAIT, LATVIA, LEBANON, LIBYA, LITHUANIA, MACEDONIA, MALAYSIA, MEXICO, MOROCCO, NEPAL, NETHERLANDS, NEW ZEALAND, NIGERIA, NORWAY, PANAMA, PARAGUAY, PERU, POLAND, PORTUGAL, QATAR, ROMANIA, RUSSIA, SAUDI ARABIA, SINGAPORE, SLOVAK IA, SLOVENIA, SOUTH AFRICA, SPAIN, SRI LANKA, SWEDEN, SWITZERLAND, SYRIA, TAIWAN, THAILAND, TUNSIA, TURKEY, UNITED ARAB EMIRATES, UNITED KINGDOM, BOLIVIA, HONG KONG, JAMAICA, PHILIPPINES, SOUTH KOREA, TRINIDAD TOBAGO, URUGUAY, VENEZUELA.","Z-2117-2013","Class II","GE Healthcare, TRAM MODULE, High-acuity patient monitoring. Product Usage: The TRAM Module is intended to provide uninterrupted monitoring of physiologic parameter data on adult, pediatric and neonatal patients during transport from one area of the hospital or facility, and monitoring system, to another. ","Mfg Lot or Serial # RT412081449GA RT412081483GA RT412091489GA RT412091490GA RT412091492GA RT412091510GA RT412091511GA RT412091517GA RT412091522GA SBB12281535GA RT412101534GA SBB12281525GA SBB12281528GA SBB12281561GA SBB12301640GA SBB12361656GA SBB12361658GA SBB12361659GA SBB12361660GA SBB12361661GA SBB12361662GA SBB12361663GA SBB12301635GA RT411220584GA RT412081484GA RT412091488GA RT412091501GA RT412101576GA RT412101599GA RT412101601GA RT412101604GA RT412101605GA RT412101606GA RT412101609GA RT412101611GA RT412101621GA RT412101624GA RT412101626GA RT412101628GA RT412101629GA RT412101632GA RT412101646GA RT412101655GA RT412101657GA RT412101661GA RT412101662GA RT412101663GA RTW11346657GA RTW11346667GA RTW11366669GA RTW11366672GA RTW11366673GA RTW11366674GA RTW11366691GA RTW11366695GA RTW11366697GA RTW11366700GA RTW11366701GA RTW11366702GA RTW11366704GA RTW11366712GA RTW11366715GAMKE RTW11366721GA RTW11366722GA RTW11366724GA RTW11366725GA RTW11366726GA RTW11366731GA RTW11366736GA RTW11366737GA RTW11366738GA RTW11366739GA RTW11366742GA RTW11366747GA RTW11366748GA RTW11366751GA RTW11366752GA SBB12281564GA SBB12281575GA SBB12301617GA SBB12301618GA SBB12301620GA SBB12301626GA SBB12301627GA SBB12301628GA SBB12301630GA SBB12301631GA SBB12131373GA SBB12301629GA SBB12281536GA SBB12281539GA SBB12281542GA SBB12281549GA SBB12281563GA SBB12301623GA SBB12301624GA SBB12301632GA SBB12301633GA SBB12301634GA SBB12301636GA SBB12301637GA SBB12301638GA SBB12301639GA SBB12301641GA SBB12301642GA SBB12301643GA SBB12301644GA SBB12301645GA SBB12301646GA RT412081429GA RT412081448GA RT412091507GA RT412101533GA RT412101536GA RTW11366717GA RTW11366732GA RTW11376817GA RTW11376819GA RTW11376821GA SBB12281533GA SBB12281537GA SBB12281538GA SBB12281540GA SBB12281545GA SBB12281548GA SBB12281551GA SBB12281552GA SBB12281553GA SBB12281554GA SBB12281556GA SBB12281557GA SBB12281558GA SBB12281562GA SBB12281565GA SBB12281566GA SBB12281574GA SBB12281576GA SBB12301621GA SBB12301622GA SBB12301625GA RTW11366716GA SBB12281547GA SBB12281559GA SBB12281531GA RT4121"," RT411060174GA RT411060175GA RT411060176GA RT411060177GA RT411070178GA RT411070179GA RT411070180GA RT411070181GA RT411070182GA RT411070183GA RT411070184GA RT411070187GA RT411070189GA RT411070197GA RT411070199GA RT411080203GA RT411080204GA RT411080206GA RT411080207GA RT411080208GA RT411080209GA RT411080212GA SBB11060498GA SBB07114365GR SBB10420140GA SBB10430150GA SBB10440293GA RT407055590GR SBB06523708GR SBB08467797GR SBB10410131GAMKE SBB10430181GA RT410449801GA RT410449803GA RTW10475164GA RTW10475179GA SBB10410105GA RTW10415038GA RTW10415058GA RTW10415059GA RTW10415060GA RTW10415061GA RTW10415062GA RTW10415063GA RTW10415064GA RTW10415066GA RTW10415067GA RTW10415068GA RTW10415069GA RTW10465079GA RTW10465080GA RTW10465081GA RTW10465085GA RTW10465086GA RTW10465087GA RTW10465088GA RTW10465089GA RTW10465090GA RTW10465092GA RTW10465093GA RTW10465095GA RTW10465097GA RTW10465098GA RTW10465100GA RTW10465102GA RTW10465104GA RTW10465106GA RTW10465107GA RTW10475173GA RT410439739GA RTW10384771GA RTW10394847GA RTW10394849GA RTW10394857GA RTW10394863GA RTW10394865GA RTW10394866GA RTW10394867GA RTW10394873GA RTW10394875GA RTW10394877GA RTW10394879GA RTW10394880GA RTW10394905GA RTW10404960GA RTW10404963GA RTW10404964GA RTW10404965GA RTW10404966GA RTW10404979GA RTW10404980GA RTW10404985GA RTW10414993GA RTW10414997GA RTW10414998GA RTW10415001GA RTW10415002GA RTW10415004GA RTW10415006GA RTW10415010GA RTW10415023GA RTW10415027GA RTW10415031GA RTW10415034GA RTW10415036GA RTW10415044GA RTW10415045GA RTW10415053GA RTW10415054GA RTW10415077GA RTW10475157GA RTW10475174GA SBB10410106GA SBB10410108GA SBB10410115GA RT410439733GA RT410439743GA RTW10394851GA RTW10394853GA RTW10394855GA RTW10394860GA RTW10394861GA RTW10394870GA RTW10394907GA RTW10404959GA RTW10404962GA RTW10404972GA RTW10404976GA RTW10404977GA RTW10404984GA RTW10404987GA RTW10404988GA RTW10414995GA RTW10415008GA RTW10415026GA RTW10415056GA RTW10415076GA SBB10410113GA SBB10410133GA SBB10309760GA SBB10400045GA SBB10430145GA RTW10415046GA RTW10415073GA SBB10400035GA SBB10400044","4807 (2167 US, 2207 OUS, & 434 unknown.","GE Healthcare has recently become aware of a potential safety issue due to intermittent noise on ECG and/or Respiration waveforms associated with movement of the ECG connector on your DASH, PDM, and/or Tram Module. ECG and Respiration signal noise caused by DASH, PDM, and/or Tram ECG cable connector movement may result in reduced ECG, Respiration and arrhythmia detection performance. ",4/3/2013,"04/03/2013",9/4/2013,"09/04/2013"
"Devices",66016,"Ongoing","GE Healthcare, LLC","Waukesha","WI","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution - USA Nationwide including DC and PR except ND and the countries of: ALGERIA, ANGOLA, ARGENTINA, AUSTRALIA, AUSTRIA, BAHAMAS, BAHRAIN, BANGLADESH, BELARUS, BELGIUM, BOSNIA-HERZEGOVINA, BRAZIL, BULGARIA, CANADA, CHILE, CHINA, COLOMBIA, COSTA RICA, CZECH REPUBLIC, DENMARK, ECUADOR, EGYPT, EL SALVADOR, FINLAND, FRANCE, GERMANY, CHANA, GREECE, HONDURAS, HUNGARY, ICELAND, INDIA, INDONESIA, IRAQ, ISRAEL, ITALY, JAPAN, JORDAN, KAZAKHSTAN, KENYA, KOREA, KUWAIT, LATVIA, LEBANON, LIBYA, LITHUANIA, MACEDONIA, MALAYSIA, MEXICO, MOROCCO, NEPAL, NETHERLANDS, NEW ZEALAND, NIGERIA, NORWAY, PANAMA, PARAGUAY, PERU, POLAND, PORTUGAL, QATAR, ROMANIA, RUSSIA, SAUDI ARABIA, SINGAPORE, SLOVAK IA, SLOVENIA, SOUTH AFRICA, SPAIN, SRI LANKA, SWEDEN, SWITZERLAND, SYRIA, TAIWAN, THAILAND, TUNSIA, TURKEY, UNITED ARAB EMIRATES, UNITED KINGDOM, BOLIVIA, HONG KONG, JAMAICA, PHILIPPINES, SOUTH KOREA, TRINIDAD TOBAGO, URUGUAY, VENEZUELA.","Z-2115-2013","Class II","GE Healthcare, Dash 3000, Dash 4000 and Dash 5000. Product Usage: The intended use of the system is to monitor physiologic parameter data on adult, pediatric and neonatal patients. ","Mfg Lot or Serial # AAB04397901GR SD007210479GR SD007231230GR SD007241751GR SD007366729GR SD007387285GR SD007387288GR SD007387291GR SD007387292GR SD007387294GR SD007439614GR SD008056174GR SD008076950GR SD008087478GR SD008138396GR SD008168769GR SD008219818GR SD008219821GR SD008356627GR SD008388272GR SD008388551GR SD008419461GR SD008419463GR SD008419495GR SD008421124GR SD008429787GR SD008429950GR SD008452355GR SD008452399GR SD008463177GR SD008516155GR SD008516281GR SD009037533GR SD009047690GR SD009088931GR SD009088944GR SD009099025GR SD009119669GR SD009121032GR SD009121171GR SD009129978GR SD009141371GA SD009141699GR SD009151940GA SD009182687GR SD009182701GR SD009182715GR SD009193075GR SD009193076GR SD009193084GR SD009193086GR SD009223767GR SD009223886GR SD009234001GR SD009234021GR SD009244557GR SD009244558GR SD009244559GR SD009244560GR SD009244564GR SD009244732GR SD009244820GR SD009255010GR SD009316784GR SD009316799GR SD009316886GR SD009316887GR SD009316899GR SD009316900GR SD009316901GR SD009316906GR SD009316909GR SD009316914GR SD009316918GR SD009316928GR SD009316933GR SD009317060GR SD009327366GR SD009327369GR SD009327371GR SD009327375GR SD009327376GR SD009358078GR SD009358079GR SD009368552GR SD009368640GR SD009400079GR SD009400082GR SD009400090GR SD009400096GR SD009400105GR SD009400109GR SD009409707GR SD009409720GR SD009409722GR SD009409748GR SD009409757GR SD009409767GR SD009409773GR SD009420737GR SD009472159GR SD009472167GR SD009513762GA SD010054455GR SD010074910GA SD010085194GR SD010095383GR SD010105782GR SD010116508GR SD010127167GR SD010127275GR SD010127663GR SD010127727GR SD010127744GA SD010127745GR SD010127802GR SD010127803GR SD010127804GR SD010127808GR SD010127809GR SD010127814GR SD010127815GR SD010138406GA SD010138409GA SD010138435GR SD010138442GA SD010138469GR SD010138494GR SD010148544GA SD010148546GA SD010148550GA SD010148560GR SD010148561GR SD010148656GR SD010148660GR SD010148692GR SD010148707GR SD010148711GR SD010148712GA SD010148719GR SD010148722GR SD010158817GR SD010158820GR SD010158981GR SD0101590"," SD010481267GA SD010481268GA SD010481271GA SD010481273GA SD010481274GA SD010481277GA SD010481278GA SD010481280GA SD010481281GA SD010481282GA SD010481283GA SD010481284GA SD010481285GA SD010481286GA SD010481287GA SD010481288GA SD010481291GA SD010481292GA SD010481293GA SD010481294GA SD010481295GA SD010481296GA SD010481297GA SD010481299GA SD010481300GA SD010481301GA SD010481302GA SD010481303GA SD010481304GA SD010481305GA SD010481306GA SD010481307GA SD010481308GA SD010491309GA SD010491312GA SD010491314GA SD010491317GA SD010491318GA SD010491319GA SD010491321GA SD010491325GA SD010491327GA SD010491328GA SD010491330GA SD010491332GA SD010491333GA SD010491334GA SD010491337GA SD010491343GA SD010491344GA SD010491345GA SD010491346GA SD010491347GA SD010491348GA SD010491352GA SD010491356GA SD010491358GA SD010491364GA SD010491380GA SD010491381GA SD010491382GA SD010491383GA SD010491384GA SD010491388GA SD010491389GA SD010491391GA SD010491392GA SD010491393GA SD010491394GA SD010491395GA SD010491398GA SD010491399GA SD010491403GA SD010491406GA SD010491407GA SD010491408GA SD010491410GA SD010491411GA SD010491412GA SD010491413GA SD010491414GA SD010491415GA SD010491416GA SD010491417GA SD010491418GA SD010491419GA SD010491420GA SD010491421GA SD010491446GA SD010491450GA SD010491454GA SD010491455GA SD010491457GA SD010491461GA SD010491462GA SD010491463GA SD010491464GA SD010491465GA SD010491466GA SD010491469GA SD010491470GA SD010491471GA SD010491472GA SD010491473GA SD010491474GA SD010491475GA SD010491476GA SD010491477GA SD010491478GA SD010491479GA SD010491480GA SD010491481GACOMPLETE SD010491482GA SD010491483GA SD010491484GACOMPLETE SD010491485GA SD010491486GA SD010491487GA SD010491488GA SD010491489GA SD010491490GA SD010491491GA SD010491492GA SD010491493GA SD010491494GA SD010491495GA SD010491496GA SD010491498GA SD010491499GA SD010491502GA SD010491505GA SD010491509GA SD010491510GA SD010491513GA SD010491514GA SD010491515GA SD010491516GA SD010491517GA SD010491518GA SD010491519GA SD010491520GA SD010491522GA SD010491524GA SD010491525GA SD010491527G","28,120 *14,709 US & 13,411 OUS)","GE Healthcare has recently become aware of a potential safety issue due to intermittent noise on ECG and/or Respiration waveforms associated with movement of the ECG connector on your DASH, PDM, and/or Tram Module. ECG and Respiration signal noise caused by DASH, PDM, and/or Tram ECG cable connector movement may result in reduced ECG, Respiration and arrhythmia detection performance. ",4/3/2013,"04/03/2013",9/4/2013,"09/04/2013"
"Veterinary",66017,"Ongoing","Virbac Corporation","Bridgeton","MO","US","Voluntary: Firm Initiated","Letter","Distribution was made to CA, FL, HI, IA, IN, KS, MD, MI, MN, MO, MS, NE, NJ, NM, OK, OR, PA, TN, TX, WI, Firm also distributed to PR.","V-004-2014","Class III","Virbac Iverhart Plus (ivermectin/pyrantel) Flavored Chewables, 68 mcg Ivermectin and 57 mg pyrantel as pamoate salt, 6 chewables/box, Recommended for dogs up to 25 lbs. ANADA 200-302. Manufactured by Virbac A, Inc, Fort Worth, TX. VETIQ Heart Shield plus (ivermectin/pyrantel), 68 mcg Ivermectin and 57 mg pyrantel as pamoate salt, 6 chewables/box, Recommended for dogs up to 25 lbs. Packaged 6 flavored chewables per blister pack. ANADA 200-302, NDC 49994-105-06. Manufactured for: TruRx, LLC, Eagle, ID. Worm Shield (ivermectin/pyrantel) Flavored Chewables, 68 mcg Ivermectin and 57 mg pyrantel as pamoate salt, 6 chewables/blister pack, Recommended for dogs up to 25 lbs. ANADA 200-302. Manufactured for: Schuyler LLC, Portland, OR.","Lot numbers and expiration dates of recalled product failing ivermectin potency: Iverhart Plus- 120092, 10/2013; 120397, 12/2013 and 120398, 11/2013. Wormshield- 120397, 12.2013. Heartshield- NONE Lot numbers and expiration dates of recalled product with passing potentcy but expected to fail: Iverhart Plus- 120195, 02/2014 and 120798, 02/2014. Wormshield- 120195, 02/2014. Heartshield- 120798, 02/2014. ",".","40,920/10/6 tablet-blister pack/display boxes","The products were identified during an ongoing investigation and testing as being out-of-specification for Ivermectin potency.",8/9/2013,"08/09/2013",11/13/2013,"11/13/2013"
"Veterinary",66017,"Ongoing","Virbac Corporation","Bridgeton","MO","US","Voluntary: Firm Initiated","Letter","Distribution was made to CA, FL, HI, IA, IN, KS, MD, MI, MN, MO, MS, NE, NJ, NM, OK, OR, PA, TN, TX, WI, Firm also distributed to PR.","V-002-2014","Class III","Virbac Iverhart Plus (ivermectin/pyrantel) Flavored Chewables, 136 mcg Ivermectin and 114 mg pyrantel as pamoate salt, 6 chewables/blister pack, Recommended for dogs 26 to 50 lbs. ANADA 200-302. Manufactured by Virbac A, Inc, Fort Worth, TX. VETIQ HeartShield Plus (ivermectin/pyrantel) Flavored Chewables, 136 mcg Ivermectin and 114 mg pyrantel as pamoate salt, 6 chewables/blister pack, Recommended for dogs 26 to 50 lbs. ANADA 200-302. NDC 49994-205-06. Manufactured for: TruRX, LLC, Eagle, ID. Worm Shield (ivermectin/pyrantel) Flavored Chewables, 136 mcg Ivermectin and 114 mg pyrantel as pamoate salt, 6 chewables/box, Recommended for dogs 26-50 lbs. ANADA 200-302. Manufactured for: Schuyler LLC, Portland, OR.","Virbac Iverhart Plus Lot numbers and expiration dates of recalled product failing ivermectin potency: 120378, 03/2014; 120090, 01/2014; 120301, 02/2014; 120305, 02/2014; 120692, 05/2014 ****Lot numbers and expiration dates of recalled product with passing potentcy but expected to fail: 121282, 10/2014 and 120450, 02/2014. Worm Sheild Lot numbers and expiration dates of recalled product failing ivermectin potency: 120090, 01/2014; 120301, 02/2014; 120305,02/2014. ****Lot numbers and expiration dates of recalled product with passing potentcy but expected to fail: 120450, 04/2014 Heartshield Lot numbers and expiration dates of recalled product failing ivermectin potency: 120692, 05/2014. ****Lot numbers and expiration dates of recalled product with passing potentcy but expected to fail: NONE ",".","32,870/10/6 tablet-blister pack/display boxes","The products were identified during an ongoing investigation and testing as being out-of-specification for Ivermectin potency.",8/9/2013,"08/09/2013",11/13/2013,"11/13/2013"
"Veterinary",66017,"Ongoing","Virbac Corporation","Bridgeton","MO","US","Voluntary: Firm Initiated","Letter","Distribution was made to CA, FL, HI, IA, IN, KS, MD, MI, MN, MO, MS, NE, NJ, NM, OK, OR, PA, TN, TX, WI, Firm also distributed to PR.","V-003-2014","Class III","Virbac Iverhart Plus (ivermectin/pyrantel) Flavored Chewables, 272 mcg Ivermectin and 227 mg pyrantel as pamoate salt, 6 chewables/blister pack, Recommended for dogs 51 to 100 lbs. ANADA 200-302. Manufactured by Virbac A, Inc, Fort Worth, TX. VETIQ HeartShield Plus (ivermectin/pyrantel) Flavored Chewables, 272 mcg Ivermectin and 227 mg pyrantel as pamoate salt, 6 chewables/blister pack, Recommended for dogs 51 to 100 lbs. ANADA 200-302. NDC 49994-305-06. Manufactured for: TruRX, LLC, Eagle, ID. Worm Shield (ivermectin/pyrantel) Flavored Chewables, 272 mcg Ivermectin and 227 mg pyrantel as pamoate salt, 6 chewables/blister pack, Recommended for dogs 51-100 lbs. ANADA 200-302. Manufactured for: Schuyler LLC, Portland, OR.","Lot numbers and expiration dates of recalled product failing ivermectin potency: Iverhart Plus- 111394, exp 12/2013; 120091, exp 01/2014; 120377, exp 03/2014; 120440, exp 04/2014120651, exp 04/2014; 120658, exp 05/2014; 120824, exp 06/2014 and 120831, exp 06/2014. Wormshield- 120093, exp 01/2014 and 120824, exp 06/2014. Heartshield- 120831, exp 06/2014. Lot numbers and expiration dates of recalled product with passing potentcy but expected to fail: Iverhart Plus- 120127, exp 02/2014; 120207, exp 02/2014; 120256, exp 01/2014; 120289, exp 02/2014; 120300, exp 02/2014; 120306, exp 02/2014; 120434, exp 03/2014; 120464, exp 04/2014; 120678, exp 05/2014; 121110, exp 07/2014; 121150, exp 09/2014; 121283, exp 10/20; and 14121386, exp 10/2014. Wormshield- 120464, exp 04/2014; 120649, exp 04/2014 and 120678, exp 05/2014. Heartshield- 120811, exp 05/2014. ",".","87,359/10/6 tablet-blister pack/display boxes","The products were identified during an ongoing investigation and testing as being out-of-specification for Ivermectin potency.",8/9/2013,"08/09/2013",11/13/2013,"11/13/2013"
"Food",66018,"Ongoing","Potters Fine Foods, LLC","Madison","WI","US","Voluntary: Firm Initiated","Telephone","IL, NY, NC, WI.","F-1868-2013","Class III","Potter's Crackers, Classic White, Net Wt 5 ounces, UPC 6 80569 15877 2, Potters Fine Foods LLC, 100 S. Baldwin, Madison WI 53703., Ingredients, Wheat Flour, Milk, Butter, Cracked Wheat, Sugar, Crystal Salt, Baking Powder, Black Pepper. Allergen Information: wheat, dairy & tree nuts.","10-10-13",".","109 containers.","Potters Fine Foods LLC are recalling Potter's Crackers Classic White because of cross contamination with a Basil Walnut Presto Cracker dough. Even though there is an allergen statement on the Classic White tag for tree nuts, we initiated a voluntary recall. All 109 packages were accounted for.",8/9/2013,"08/09/2013",9/11/2013,"09/11/2013"
"Biologics",66019,"Terminated","Kaiser Foundation Hospital","Woodland Hills","CA","US","Voluntary: Firm Initiated","Telephone","California","B-2519-13","Class II","Red Blood Cells","W072011004019; ",".","1","Blood products, collected from a donor considered to be at increased risk for variant Creutzfeldt-Jakob Disease (vCJD), were distributed. ",6/5/2013,"06/05/2013",11/13/2013,"11/13/2013"
"Biologics",66019,"Terminated","Kaiser Foundation Hospital","Woodland Hills","CA","US","Voluntary: Firm Initiated","Telephone","California","B-2520-13","Class II","Plasma Frozen within 24 hours (FP24)","W072011004019; ",".","1","Blood products, collected from a donor considered to be at increased risk for variant Creutzfeldt-Jakob Disease (vCJD), were distributed. ",6/5/2013,"06/05/2013",11/13/2013,"11/13/2013"
"Biologics",66020,"Terminated","Antigen Laboratories Inc","Liberty","MO","US","Voluntary: Firm Initiated","Telephone","Multiple U.S. States","B-2458-13","Class III","Birch, White","B44060111A",,"1","Allergenic Extracts, reprocessed by an unapproved process, were distributed. ",8/2/2013,"08/02/2013",10/23/2013,"10/23/2013"
"Biologics",66021,"Terminated","Southern California Permanente Medical Group Blood Donor Ctr","Downey","CA","US","Voluntary: Firm Initiated","Telephone","California","B-2516-13","Class II","Platelets Pheresis Leukocytes Reduced","W071813010687; ",".","1","Blood product, labeled as leukoreduced without the assurance that it met the criteria for a leukoreduced product, was distributed.",7/8/2013,"07/08/2013",11/13/2013,"11/13/2013"
"Biologics",66022,"Terminated","Bio-Rad Medical Diagnostics GmbH","Dreieich",,"DE","Voluntary: Firm Initiated","Letter","Multiple U.S. States","B-0064-14","Class III","Blood Grouping Reagent, Anti-S (Monoclonal)","822304001; 8244076001",".","2 vials","Seraclone Anti-S with a reactivity decrease after approximately 12 months, was distributed. ",8/5/2013,"08/05/2013",12/11/2013,"12/11/2013"
"Food",66023,"Ongoing","Buurma Farms Inc","Willard","OH","US","Voluntary: Firm Initiated","Telephone","Product was distributed to the following states: IL, IN, MI and OH.","F-1852-2013","Class I","Buurma Farms Cilantro, fresh, 4 oz bunch, #4889 UPC 0 33383 80104 9","Lot # 02D312A4",,"468 boxes","The firm was notified by one of their customers of a positive Listeria monocytogenes results they received from the Michigan Department of Agriculture.",8/15/2013,"08/15/2013",9/4/2013,"09/04/2013"
"Devices",66024,"Ongoing","Villa Radiology Systems LLC","Oxford","CT","US","Voluntary: Firm Initiated","Letter","US Nationwide Distribution including the states of AZ, MI, IN, UT, CT, AL, NY, PA, IL, MD, CA, MA, IA, OH, MS and MO.","Z-2160-2013","Class II","Juno DRF System. Mobile X-ray system These are general, multi-function x-ray systems capable of routine radiographs and general fluoroscopy procedures","PN 709020",,"22 units within US","It has been discovered that the Air Kerma rate information is inconsistent in Continuous Fluoro modes 30x30 (12''x12'') and 15x15 (6''x6). This could result in a deviation of the displayed values of Air Kerma Rate and Cumulated Air Kerma from the actual values greater then +/-35% and then in a failure to comply with the requirements of 21 CFR 1020.32(k)(6 ",8/2/2013,"08/02/2013",9/25/2013,"09/25/2013"
"Devices",66025,"Ongoing","Draeger Medical, Inc.","Telford","PA","US","Voluntary: Firm Initiated","Letter","Worldwide distribution: US (nationwide) and countries of: Argentina, Australia, Austria, Azerbaijan, Bangladesh, Brazil, Bulgaria, Canada, Chile, China, Columbia, Ecuador, Egypt, France, Germany, Greece, Hungary, India, Indonesia, Israel, Italy, Ivory Coast, Japan, Kazakhstan, Latvia, Libya, Lithuania Malaysia, Morocco, Myanmar, Nepal, Philippines, Poland, Rumania, Russian Fed., Saudi Arabia, Senegal, South Africa, South Korea, Spain, Sweden, Switzerland, Taiwan, Turkey, United Kingdom, Uruguay, Vietnam, White Russia Turkmenistan.","Z-0008-2014","Class I","Draeger Fabius GS Premium, Fabius OS, Fabius Tiro, Fabius Tiro D-M used to administer anesthesia and ventilation to patients during surgical procedures.","Part Nos. 8607000 (GS Permium) 8606000 (Fabius OS and Fabius Tiro) 8608400 (Fabius Tiro D-M)ASEC-0055 with lot numbers: ASEC-0186, ASED-0006, ASED-0074, ASED-0291, ASEC-0056, ASEC-0205, ASED-0007, SED-0075 ASED-0292, ASEC-0061, ASEC-0206, ASED-0020, ASED-0079, ASED-0293, ASEC-0062, ASEC-0207, ASED-0021, ASED-0139, ASED-0294, ASEC-0070, ASEC-0208, ASED-0023, ASED-0160, ASED-0295, ASEC-0071, ASEC-0209, ASED-0024, ASED-0161, ASED-0296, ASEC-0112, ASEC-0210, ASED-0025, ASED-0162, ASEE-0021, ASEC-0124, SEC-0211, ASED-0031, ASED-0163, ASEE-0022, ASEC-0125, ASEC-0212, ASED-0032, ASED-0164, ASEE-0023, ASEC-0126, ASEC-0213, ASED-0033, ASED-0165, ASEE-0041, ASEC-0169, ASEC-0214, ASED-0034, ASED-0166, ASEE-0042, ASEC-0170, ASEC-0236, ASED-0035, ASED-0167, ASEE-0058, ASEC-0171, ASEC-0248, ASED-0036, ASED-0168, ASEE-0060, ASEC-0172, ASEC-0249, ASED-0037, ASED-0169, ASEE-0061, ASEC-0173, ASEC-0250, ASED-0038, ASED-0203, ASEE-0065, ASEC-0174, ASED-0001, ASED-0044, ASED-0253, ASEE-0066, ASEC-0175, ASED-0002, ASED-0045, ASED-0286, ASEE-0083, ASEC-0176, ASED-0003, ASED-0046, ASED-0287, ASEE-0103, ASEC-0184, ASED-0004, ASED-0047, ASED-0288, ASEE-0136, ASEC-0185, ASED-0005, ASED-0051, ASED-0290, ASEC-0054, ASEC-0194, ASED-0247, ASED-0263, ASEE-0072, ASEC-0167, ASEC-0195, ASED-0248, ASED-0264, ASEE-0089, ASEC-0178, ASEC-0196, ASED-0254, ASED-0265, ASEE-0090, ASEC-0179, ASEC-0197, ASED-0255, ASED-0266, ASEE-0131, ASEC-0180, ASEC-0227, ASED-0256, ASED-0282, ASEE-0132, ASEC-0181, ASEC-0228, ASED-0257, ASEE-0003, ASEE-0133, ASEC-0182, ASED-0040, ASED-0260, ASEE-0017, ASEE-0134, ASEC-0183, ASED-0086, ASED-0261, ASEE-0054, ASEC-0193, ASED-0245, ASED-0262, ASEE-0071, ASED-0141, ASED-0143, ASED-0145, ASED-0147, ASED-0149, ASED-0142, ASED-0144, ASED-0146, ASED-0148, ASEB-0219 ",".","1127 units","During final testing of the Draeger Fabius GS Premium, Fabius OS, and Fabius Tiro anesthesia machines, some units did not pass the high voltage test and the minimum clearance between an electrical component and the unit housing was not maintained for some from a specific batch. ",8/14/2013,"08/14/2013",10/16/2013,"10/16/2013"
"Devices",66026,"Ongoing","Cordis Corporation","Miami Lakes","FL","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution - USA Nationwide in the states of AZ, CA, FL, ID, LA, MA, MD, MI, MN, MO, NC, NH, NY, OH, OK, PA, SC, TX, VA, WI, and WV and the countries of: Austria, Belgium, Czech Republic, France, Germany, Greece,Hungary, Israel, Italy, Latvia, Netherlands, Poland, Portugal, Russian Federation, Slovenia, Spain, Sweden, Switzerland, United Arab, and United Kingdom","Z-0003-2014","Class II","Cordis ADROIT 6F Guiding Catheter Product Usage: For intravascular introduction of interventional and/or diagnostic devices into the coronary or peripheral vascular system. ","Catalog Lots ---------------------------------- 67200000 15918614 67200200 15892736 67200400 15892737, 15897416 67200500 15901314 67203400 15922021 67203600 15897418 67204000 15925687 67205200 15892738, 15892739 67205400 15885645, 15887472, 15897420 67205600 15901319 67206000 15897422 67207200 15892740 67208000 15892741 67208200 15887473, 15887474, 15897424 67208300 15901321 67212600 15916942 67213000 15916943 67227000 15901323 ",,"1238 units","Due to a labeling error related to the conversion of the inner diameter of the catheter from inches to millimeters. The English dimension is correct and is the primary dimension. ",8/12/2013,"08/12/2013",10/9/2013,"10/09/2013"
"Devices",66027,"Ongoing","Sonogage Inc","Cleveland","OH","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution - USA Nationwide in the following states: AK, AZ, CA, FL, GA, IL, KY, LA, MA, MD, MN, NE, NJ, NM, NY, OH, OR, PA, TX, VA and WA; and countries of Canada and Mexico.","Z-2202-2013","Class II","Sonogage EyeScan, A-Scan Biometer, Product Usage: A-Scan Biometer diagnostic device for measurement of axial eye length.","Serial #: ES10001 - ES10002, ES10004 -ES10012, ES10014 - ES10040, ES10042 - ES100167, ES10170-ES10185, ES10187 - ES10214, ES10218 - ES10224, ES10226, ES10228 - ES10230, ES10233, ES10235-ES10242, ES10244 - ES10252, ES1024-ES10426, ES10253 - ES10260, ES10262, ES10267 - ES10277, ES10279 - ES10306, ES10308 - ES10347, ES10349-ES10357, ES10359 - ES10423, ES10427 - ES10444, ES10446 - ES10472, ES10474, ES10476 - ES10478, ES10481 - ES10483, ES10485 - ES10508, ES10510, ES10512 - ES10529, ES10531 - ES10543, ES10545 - ES10546, ES10548 - ES10558, ES10560 - ES10566, ES10568 - ES10570, ES1059, T10217 & T80002-T80020.",,"564 units","During an FDA inspection on 7/15-26/2013, it was discovered that the firm lacked registration and 510(k) clearance for the device.",8/9/2013,"08/09/2013",9/25/2013,"09/25/2013"
"Food",66028,"Ongoing","See's Candies Inc.","South San Francisco","CA","US","Voluntary: Firm Initiated","E-Mail","See's retail store and Licensees in US and Hong Kong and Taiwan and mail order US only.","F-1853-2013","Class I","See's Candies, Van Doren Dark Chocolate Blueberries; 8 oz. clear plastic packages. See's Candies Inc./See's Candy Shops Inc: South San Francisco, CA 94080/Los Angeles, CA 90016","8 oz UPC: 737666094479. Stock boxes SKU 9458. These are ~ 3.78 lb boxes sent to stores where they are packed into 8 oz bags. KSU 9447 - 1- lb.cases of 8oz x 20 bags sent to licensees.",,"8,327 lbs.","Investigation into a consumer complaint revealed that ''milk: had been erroneously omitted from the ingredient statement of Dark Chocolate covered Blueberries.",8/17/2013,"08/17/2013",9/4/2013,"09/04/2013"
"Devices",66029,"Ongoing","MicroAire Surgical Instruments, LLC","Charlottesville","VA","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution - USA (nationwide) and internationally to Australia, Ireland, Canada, Netherlands, Sweden, Japan, and United Kingdom.","Z-2158-2013","Class II","Steinmann Pin, packed in a clear tube with end caps, tubes packed in a sterile barrier pouch, 6 pouches/sales unit. Pouches are labeled in part ***MicroAire Surgical Instruments 3590 Grand Forks Blvd Charlottesville, VA LLC 22911*** Models: 1620-109 1636-509 1620-509 1640-509 1620-609 1648-509 1620-709 1648-509T 1624-109 1648-609 1624-509 1648-609T 1624-509T 1628-509 1632-509 1632-609 A smooth or threaded wire / pin that may be used for fixation of bone fractures, for bone reconstructions, as a guide pin for insertion of other implants, or it may be implanted through the skin so that a pulling force (traction) may be applied to the skeletal system. ","Product # Lot Number 1620-109 0213216244 1620-109 0213216804 1620-109 0313217447 1620-109 0413219296 1620-109 0413219479 1620-109 0613222208 1620-509 0213216077 1620-509 0213216598 1620-509 0213216740 1620-509 0313217912 1620-509 0313217980 1620-509 0413219446 1620-509 0413219514 1620-509 0513220340 1620-509 0613222209 1620-509 0613222677 1620-509 0613222950 1620-609 0213216021 1620-609 0213216987 1620-609 0313218036 1620-609 0413218860 1620-709 0313217801 1620-709 0413218861 1620-709 0513220659 1620-709 0613222204 1620-709 0613222465 1620-709 0613223531 1620-709 0713224375 1624-109 0213216721 1624-109 0313218583 1624-109 0413219836 1624-109 0413219934 1624-109 0613222761 1624-109 0713223840 1624-509 0213216018 1624-509 0213217203 1624-509 0313217576 1624-509 0313218461 1624-509 0413219480 1624-509T 0213215841 1628-509 0213217207 1628-509 0413219845 1628-509 0513220335 1628-509 0513220422 1628-509 0613222210 1632-509 0213216079 1632-509 0213216820 1632-509 0313218668 1632-509 0313218715 1632-509 0513220951 1632-509 0613222467 1632-509 0613223364 1632-609 0413219600 1636-509 0313218458 1636-509 0413218937 1640-509 0213216975 1640-509 0213216985 1640-509 ",".","15786 total units ","A medical device used in surgical procedures was packaged in a pouch in which a defective seal may compromise sterility",8/12/2013,"08/12/2013",9/11/2013,"09/11/2013"
"Devices",66029,"Ongoing","MicroAire Surgical Instruments, LLC","Charlottesville","VA","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution - USA (nationwide) and internationally to Australia, Ireland, Canada, Netherlands, Sweden, Japan, and United Kingdom.","Z-2159-2013","Class II","Kirschner-Wire (K-Wire), packed in a clear tube with end caps, tubes packed in a sterile barrier pouch, 6 pouches/sales unit. Pouches are labeled in part ***MicroAire Surgical Instruments 3590 Grand Forks Blvd Charlottesville, VA LLC 22911*** Models: 1620-109 1636-509 1620-509 1640-509 1620-609 1648-509 1620-709 1648-509T 1624-109 1648-609 1624-509 1648-609T 1624-509T 1628-509 1632-509 1632-609 A smooth or threaded wire / pin that may be used for fixation of bone fractures, for bone reconstructions, as a guide pin for insertion of other implants, or it may be implanted through the skin so that a pulling force (traction) may be applied to the skeletal system. ","Product # Lot Number 1600-020 0213215913 1600-020 0413220145 1600-020 0513220342 1600-020 0513220769 1600-020 0513220952 1600-020 0513221114 1600-020 0513221302 1600-020 0513221825 1600-020 0613222383 1600-020 0613222462 1600-021 0213216019 1600-021 0213217287 1600-021 0413218802 1600-021 0413219838 1600-021 0513220423 1600-021 0513220876 1600-021 0513221009 1600-021 0513221948 1600-021 0613222759 1600-022 0213215911 1600-022 0213216599 1600-022 0213217105 1600-022 0313217635 1600-022 0313217978 1600-022 0313218584 1600-022 0413218936 1600-022 0413219297 1600-022 0413219980 1600-022 0513220829 1600-022 0513221303 1600-022 0613222034 1600-022 0613222678 1600-022 0613223243 1600-022 0713223715 1600-023 0213216601 1600-023 0213217285 1600-023 0313217910 1600-023 0313218074 1600-023 0313218484 1600-023 0413218804 1600-023 0413219743 1600-023 0413220193 1600-023 0513220503 1600-023 0513221006 1600-023 0513221626 1600-023 0613222540 1600-023 0613222904 1600-023 0613223365 1600-023 0713223833 1600-428 0213217031 1600-428 0313217802 1600-428 0413218859 1600-428 0513220955 1600-428 0513221177 1600-428 0513221823 1600-435 0213216017 1600-435 0213216556 1600-435 0313217847 1600-435 0313218304 1600-435 0313218674 1600-435 0413219524 1600-435 0513220338 1600-435 0513220771 1600-435 0513221437 1600-435 0613222206 1600-435 0613222830 1600-445 0213216300 1600-445 0213217030 1600-445 0313217486 1600-445 0313217982 1600-445 0313218460 1600-445 0413218932 1600-445 0413219482 1600-445 0413220192 1600-445 0513220767 1600-445 0513221373 1600-445 0513221949 1600-445 0613222384 1600-445 0613222829 1600-445 0613223467 1600-454 0213216405 1600-454 0213216976 1600-454 0213217206 1600-454 0313217485 1600-454 0313218485 1600-454 0413219153 1600-454 0413219846 1600-454 0513221175 1600-462 0213216245 1600-462 0213216743 1600-462 0213217289 1600-462 0313218035 1600-462 0313218589 1600-462 0413219157 1600-462 0413219981 1600-462 0513220875 1600-462 0513221558 1600-462 0613222281 1600-462 0613222902 1600-462 0613223525 1600-462T 0213217106 160",".","15786 total units","A medical device used in surgical procedures was packaged in a pouch in which a defective seal may compromise sterility",8/12/2013,"08/12/2013",9/11/2013,"09/11/2013"
"Devices",66031,"Ongoing","Becton Dickinson & Company","Franklin Lakes","NJ","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Distributed in the states of CT, KY, IL, NY, PA, TX, and VA and the country of Canada.","Z-2192-2013","Class II","BD Microtainer Quikheel Lancet 1.0 mm incision Depth 2.5 mm Incision Length REF 368101 Rx Only Becton, Dickinson and Company, Franklin Lakes, NJ 07417 USA Made in USA. Used to perform heel sticks for the purpose of collecting skin puncture blood.","REF # 368101 Lot #3116007 Class I Exempt Device listing Number E158602",".","US - 39,800 units ; Canada - 18,400 units","The Lancet will not retract after activation thus creating a potential for exposure to a used sharp. ",7/10/2013,"07/10/2013",9/18/2013,"09/18/2013"
"Drugs",66032,"Ongoing","Bracco Diagnostics Inc","Monroe Township","NJ","US","Voluntary: Firm Initiated","Letter","Nationwide","D-914-2013","Class III","Tagitol V Barium Sulfate Suspension (40% w/v, 30% w/w) Net Contents: 20 mL, (NDC 32909-814-53) Rx Only, Manufactured by E-Z-EM Canada Inc., a subsidiary of E-Z-EM, Inc. Lake Success, NY 11042 Tel: 1-516-333-8230 1-800-544-4624 NDC 32909-814-53","Lot #65846",".","3,096 bottles","Failed Stability Specifications: Tagitol V Barium Sulfate Lot #65846 sampled at 10 months exhibited results above the upper specification for viscosity.",7/19/2013,"07/19/2013",8/28/2013,"08/28/2013"
"Food",66034,"Ongoing","S & M International Inc","Bayonne","NJ","US","Voluntary: Firm Initiated","Letter","NY","F-1835-2013","Class III","Grove Grow Notes Dried Mushroom, Net Wt. 200g/7 oz. packaged in plastic tray in plastic bag. UPC 6949682800734 Product of China Product label is in Chinese","UPC 6949682800734 ",".","100 packages","Grove Grow Notes Dried Mushrooms contain undeclared sulfites at a level of 59 ppm.",6/11/2013,"06/11/2013",8/28/2013,"08/28/2013"
"Food",66035,"Ongoing","Greenland Trading Corp","Paterson","NJ","US","Voluntary: Firm Initiated","Telephone","CT, FL, MA, NJ & NY","F-1872-2013","Class III","El Basham Weight 400 g Ingredients: Natural Apricot Juice, Glucose, Sugar, Oil. Made by: For the Owner of the Trade Mark ABU Ode h Bros Co. Amok St. Aman -Jordan Tel +962 6 4914961 Fax +962 6 4907878 Remaining information is in Arabic.","None listed in Attachment B. However, the outside markings on the label has an expiration date code 6/2012-6/2014 (Attachment #2 2 of 2 and in Memorandum Report dated June 14, 2013. ",".","100 cases (20 units each)","Kamar Deen AL Basham Apricot Dried Paste does not declare product identity in English.",7/15/2013,"07/15/2013",9/11/2013,"09/11/2013"
"Devices",66036,"Ongoing","Roche Molecular Systems, Inc.","Branchburg","NJ","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution - USA (nationwide) including the countries of Austria, Australia, Belgium, Brazil, Czech Rep, Canada, Croatia, Columbia, Denmark, Dominican Republic, Germany, Ecuador, France, Japan, Greenland, Mexico, Italy, New Zealand, Netherlands, Peru, Norway, Singapore, Romania, South Africa, Spain, South Korea, Sweden, Switzerland and UK.","Z-2173-2013","Class II","KIT cobas 4800 HPV AMP/DET 240T / 960T US-IVD, CE-IVD Roche Molecular System, Inc. 1080 US highway 202 South Branchburg, NJ 08876 USA Roche Diagnostics 9115 Hague Road Indianapolis, IN 46250-0457 USA The cobas HPV Test is a qualitative in vitro test for the detection of Human Papillomavirus in patient specimens. The test utilizes amplification of target DNA by the Polymerase Chain Reaction (PCR) and nucleic acid hybridization for the detection of 14 high-risk (HR) HPV types in a single analysis. The test specifically identifies types HPV16 and HPV18 while concurrently detecting the rest of the high risk types (31, 33, 35, 39, 45, 51, 52, 56, 58, 59, 66 and 68). The cobas HPV Test is indicated: (a) To screen patients 21 years and older with ASC-US (Atypical squamous cells of undetermined significance) cervical cytology test results to determine the need for referral to colposcopy. (b) To be used in patients 21 years and older with ASC-US cervical cytology results, to assess the presence or absence of high-risk HPV genotypes 16 and 18. This information, together with the physicians assessment of cytology history, other risk factors, and professional guidelines, may be used to guide patient management. The results of this test are not intended to prevent women from proceeding to colposcopy. (c) In women 30 years and older, the cobas HPV Test can be used with cervical cytology to adjunctively screen to assess the presence or absence of high risk HPV types. This information, together with the physicians assessment of cytology history, other risk factors, and professional guidelines, may be used to guide patient management. (d) In women 30 years and older, the cobas HPV Test can be used to assess the presence or absence of HPV genotypes 16 and 18. This information, together with the physicians assessment of cytology history, other risk factors, and professional guidelines, may be used to guide patient management. Cervical specimens that may be tested with the cobas HPV Test include the following liquid based col","US-IVD: Material number 05232880190 Lot Number R13814, R15785 CE-IVD: Material Number: 05235898190 05235898190 05235901190 05235910190 Lot Number R15771, R15304 ",".","US-IVD: 350 Kits; CE-IVD: 441 KITS","During an internal investigation, a formulation error that occurred was identified during the manufacture of the cobas 4800 HPV Master Mix reagent that was packaged in four (4) cobas 4800 AMP/DET kits, US- and CE-IVD (240 and 960 test kit configurations). Examination of the batch production record of the material revealed there was an error in the tare weight used for the carboy during the final volume adjustment of the bulk material. This resulted in the Master Mix reagent being brought up to a lower volume than intended; as a result, the concentration of every component in the Master Mix was high by 12.7% on average. ",7/25/2013,"07/25/2013",9/18/2013,"09/18/2013"
"Devices",66037,"Ongoing","Smith & Nephew, Inc. Endoscopy Division","Andover","MA","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution - USA (nationwide) Canada, Europe: Austria, Belgium, Cyprus, Czech Republic, Denmark, Germany, Greece, Finland, France, Italy, Ireland, Luxembourg, Netherlands, Norway, Poland, Portugal, Russia, Slovenia, Spain, Sweden, Switzerland, Turkey, Ukraine and United Kingdom, Asia-pacific: Australia, China, Dubai, Hong Kong, India, Japan, Malaysia, New Zealand, Philippines, Sri Lanka, Singapore, South Korea, Taiwan, Thailand, Argentina, Bermuda, Brazil, Chile, Colombia, Costa Rica, Israel, Mexico, Puerto Rico, South Africa, and Venezuela.","Z-2219-2013","Class II","BIORAPTOR 2.9 mm Suture Anchor, pack of 1 ULTRABRAID Suture: 72200689 Biodegradable suture anchor","50257249 50266395 50266956 50273021 50274566 50292663 50298060 50310769 50312085 50312489 50314911 50319308 50320226 50365776 50366000 50372062 50372899 50373577 50430178 50430381 50432333 50433339 50435314 50437523 ",,"240 US","Pinholes detected in a small number of primary pouches that may constitute a breach of the sterile barrier. ",8/6/2013,"08/06/2013",9/25/2013,"09/25/2013"
"Devices",66037,"Ongoing","Smith & Nephew, Inc. Endoscopy Division","Andover","MA","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution - USA (nationwide) Canada, Europe: Austria, Belgium, Cyprus, Czech Republic, Denmark, Germany, Greece, Finland, France, Italy, Ireland, Luxembourg, Netherlands, Norway, Poland, Portugal, Russia, Slovenia, Spain, Sweden, Switzerland, Turkey, Ukraine and United Kingdom, Asia-pacific: Australia, China, Dubai, Hong Kong, India, Japan, Malaysia, New Zealand, Philippines, Sri Lanka, Singapore, South Korea, Taiwan, Thailand, Argentina, Bermuda, Brazil, Chile, Colombia, Costa Rica, Israel, Mexico, Puerto Rico, South Africa, and Venezuela.","Z-2220-2013","Class II","OSTEORAPTOR 2.3 mm Suture Anchor with ULTRABRAID COBRAID Suture, Blue; Part Number: 72201993 Biodegradable suture anchor","50261071 50265227 50268236 50270124 50270127 50270731 50270732 50270944 50272331 50272463 50272751 50274143 50274349 50277106 50278834 50281659 50282211 50282825 50283848 50285062 50287130 50288422 50289369 50291056 50292247 50293722 50295044 50295954 50297046 50298435 50299024 50301146 50301385 50302078 50306608 50307181 50307859 50308888 50308912 50309137 50311191 50312587 50314102 50315238 50316441 50316664 50317482 50317875 50318971 50319908 50320248 50321101 50321648 50322088 50322930 50323639 50324385 50325610 50325737 50326879 50327995 50328245 50329009 50329813 50330435 50332245 50333093 50333956 50334115 50334402 50335321 50336229 50336882 50337043 50337449 50338243 50338995 50339833 50340161 50341063 50341287 50341846 50342910 50343441 50344016 50344263 50344619 50346628 50347009 50347537 50348331 50349439 50350189 50350979 50351681 50351959 50352540 50353155 50353497 50353607 50354099 50355298 50355824 50356121 50356985 50357105 50357560 50358205 50358555 50359713 50360281 50360451 50361177 50362090 50362645 50362978 50363189 50363545 50364184 50364663 50364910 50364911 50364912 50369681 50369960 50370096 50370209 50371913 50373322 50373580 50374378 50375175 50375582 50375896 50376045 50376616 50376834 50377164 50377317 50379208 50379388 50379938 50380822 50381057 50381374 50381815 50382801 50383513 50384164 50384951 50385489 50385824 50386925 50387321 50387880 50387895 50388430 50389103 50390008 50390942 50391228 50391627 50392267 50392391 50393196 50393760 50394180 50396181 50396831 50397271 50397460 50398372 50398722 50399414 50399815 50400186 50400942 50401453 50401757 50401920 50402611 50402824 50403368 50403711 50403712 50404421 50404748 50405574 50406025 50406508 50407109 50407568 50408211 50408883 50410215 50409543 50409822 50410771 50411055 50412025 50412274 50412888 50413142 50413774 504142",,"25733","Pinholes detected in a small number of primary pouches that may constitute a breach of the sterile barrier. ",8/6/2013,"08/06/2013",9/25/2013,"09/25/2013"
"Devices",66037,"Ongoing","Smith & Nephew, Inc. Endoscopy Division","Andover","MA","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution - USA (nationwide) Canada, Europe: Austria, Belgium, Cyprus, Czech Republic, Denmark, Germany, Greece, Finland, France, Italy, Ireland, Luxembourg, Netherlands, Norway, Poland, Portugal, Russia, Slovenia, Spain, Sweden, Switzerland, Turkey, Ukraine and United Kingdom, Asia-pacific: Australia, China, Dubai, Hong Kong, India, Japan, Malaysia, New Zealand, Philippines, Sri Lanka, Singapore, South Korea, Taiwan, Thailand, Argentina, Bermuda, Brazil, Chile, Colombia, Costa Rica, Israel, Mexico, Puerto Rico, South Africa, and Venezuela.","Z-2236-2013","Class II","TWINFIX Ultra PLLA/HA 6.5 mm with 3 ULTRABRAID Suture; Part Number: 72202610 Biodegradable suture anchor","50325166 50325167 50327043 50336737 50336772 50339647 50339842 50341976 50385698 50397465 50412290 50417528 50426452 50427818 50429624 50429874 50431563 50453525 ",,"1643","Pinholes detected in a small number of primary pouches that may constitute a breach of the sterile barrier. ",8/6/2013,"08/06/2013",9/25/2013,"09/25/2013"
"Devices",66037,"Ongoing","Smith & Nephew, Inc. Endoscopy Division","Andover","MA","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution - USA (nationwide) Canada, Europe: Austria, Belgium, Cyprus, Czech Republic, Denmark, Germany, Greece, Finland, France, Italy, Ireland, Luxembourg, Netherlands, Norway, Poland, Portugal, Russia, Slovenia, Spain, Sweden, Switzerland, Turkey, Ukraine and United Kingdom, Asia-pacific: Australia, China, Dubai, Hong Kong, India, Japan, Malaysia, New Zealand, Philippines, Sri Lanka, Singapore, South Korea, Taiwan, Thailand, Argentina, Bermuda, Brazil, Chile, Colombia, Costa Rica, Israel, Mexico, Puerto Rico, South Africa, and Venezuela.","Z-2215-2013","Class II","BIORAPTOR 2.9 mm Suture Anchor with 2 ULTRABRAID Suture; Part Number: 72200775 Biodegradable suture anchor","50252371, 50252817, 50252818, 50253051, 50253556, 50254393, 50255140, 50255943, 50257230, 50257886, 50258390, 50258813, 50259145, 50259748, 50259820, 50260127, 50261934, 50263317, 50263909, 50264101, 50264417, 50264775, 50265257, 50265457, 50265935, 50266338, 50266709, 50266926, 50267287, 50267297, 50267742, 50268009, 50268284, 50268801, 50269502, 50269812, 50270227, 50270716, 50271271, 50271608, 50271908, 50272544, 50273015, 50273358, 50273640, 50273933, 50274557, 50274799, 50275368, 50276253, 50276254, 50276805, 50277029, 50277294, 50277527, 50277929, 50278456, 50278571, 50278899, 50279282, 50279628, 50279887, 50280270, 50280509, 50280951, 50281119, 50281654, 50281988, 50282538, 50282785, 50283315, 50283661, 50284261, 50284507, 50285047, 50285232, 50286292, 50286603, 50287484, 50287742, 50287951, 50288412, 50288413, 50288709, 50288711, 50289018, 50289361, 50289598, 50290037,50290863, 50291536, 50291656, 50292239, 50292240, 50292919, 50293285, 50293609, 50293897 50294168, 50294377, 50295055, 50295263 50296219 50296742 50297227 50297778 50297779 50297780 50298062 50298419 50298786 50299246 50299545 50299546 50299826 50300216 50300804 50301267 50301404 50302151 50302685 50303058 50303427 50303788 50303941 50304178 50304532 50305224 50305593 50306159 50306607 50306999 50307177 50307178 50307323 50307855 50308129 50308350 50308876 50309006 50309569 50309929 50310088 50310360 50310603 50311024 50311465 50311593 50312088 50312508 50312903 50313096 50313194 50313433 50313434 50313810 50313981 50314087 50314275 50314383 50314587 50314734 50314912 50315220 50315412 50315573 50316170 50316287 50316663 50316991 50317294 50317333 50317334 50319134 50319316 50319548 50319721 50320087 50320539 50320883 50321123 50321480 50321923 50322389 50322921 50323075 50323255 50323447 50323635 50323776 50324607 50326329 50327629 50327993 50331045 50328867 50329238 50331335 50331336 50331537 50332615 50332903 50333951 5033437",,"43385 US","Pinholes detected in a small number of primary pouches that may constitute a breach of the sterile barrier. ",8/6/2013,"08/06/2013",9/25/2013,"09/25/2013"
"Devices",66037,"Ongoing","Smith & Nephew, Inc. Endoscopy Division","Andover","MA","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution - USA (nationwide) Canada, Europe: Austria, Belgium, Cyprus, Czech Republic, Denmark, Germany, Greece, Finland, France, Italy, Ireland, Luxembourg, Netherlands, Norway, Poland, Portugal, Russia, Slovenia, Spain, Sweden, Switzerland, Turkey, Ukraine and United Kingdom, Asia-pacific: Australia, China, Dubai, Hong Kong, India, Japan, Malaysia, New Zealand, Philippines, Sri Lanka, Singapore, South Korea, Taiwan, Thailand, Argentina, Bermuda, Brazil, Chile, Colombia, Costa Rica, Israel, Mexico, Puerto Rico, South Africa, and Venezuela.","Z-2228-2013","Class II","OSTEORAPTOR CURVED 2.3 mm Suture Anchor SA ULTRABRAID COBRAID Suture, Blue; Part Number: 72203290 Biodegradable suture anchor","50364854 50366872 50366972 50366980 50366985 50366989 50370760 50370771 50370940 50371292 50376475 50385813 50386237 50386563 50386749 50388066 50391012 50394695 50396184 50400301 50400306 50400307 50403488 50404241 50406445 50407524 50407571 50410789 50411371 50414977 50415258 50415670 50416148 50417206 50418093 50418993 50420658 50423443 50429652 50430190 50430402 50431731 50433933 50435319 50441441 50442649 50444415 50445034 50445760 50447482 50448060 50448722 50450469 50451783 50453148 50454104 50455627 50456912 50458608 50460242 ",,"10296 US","Pinholes detected in a small number of primary pouches that may constitute a breach of the sterile barrier. ",8/6/2013,"08/06/2013",9/25/2013,"09/25/2013"
"Devices",66037,"Ongoing","Smith & Nephew, Inc. Endoscopy Division","Andover","MA","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution - USA (nationwide) Canada, Europe: Austria, Belgium, Cyprus, Czech Republic, Denmark, Germany, Greece, Finland, France, Italy, Ireland, Luxembourg, Netherlands, Norway, Poland, Portugal, Russia, Slovenia, Spain, Sweden, Switzerland, Turkey, Ukraine and United Kingdom, Asia-pacific: Australia, China, Dubai, Hong Kong, India, Japan, Malaysia, New Zealand, Philippines, Sri Lanka, Singapore, South Korea, Taiwan, Thailand, Argentina, Bermuda, Brazil, Chile, Colombia, Costa Rica, Israel, Mexico, Puerto Rico, South Africa, and Venezuela.","Z-2217-2013","Class II","BIORAPTOR 2.9 mm Suture Anchor with DURABRAID'' Suture; Part Number: 72200783 Biodegradable suture anchor","50281125 50284266 50287760 50291931 50296472 50300113 50311609 50316176 50321099 50328710 50345983 50346630 50347152 50375169 50379044 50391248 50392390 50409415 50414558 50419568 50421350 50443184 50447005 50449127 ",,"1735 US","Pinholes detected in a small number of primary pouches that may constitute a breach of the sterile barrier. ",8/6/2013,"08/06/2013",9/25/2013,"09/25/2013"
"Devices",66037,"Ongoing","Smith & Nephew, Inc. Endoscopy Division","Andover","MA","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution - USA (nationwide) Canada, Europe: Austria, Belgium, Cyprus, Czech Republic, Denmark, Germany, Greece, Finland, France, Italy, Ireland, Luxembourg, Netherlands, Norway, Poland, Portugal, Russia, Slovenia, Spain, Sweden, Switzerland, Turkey, Ukraine and United Kingdom, Asia-pacific: Australia, China, Dubai, Hong Kong, India, Japan, Malaysia, New Zealand, Philippines, Sri Lanka, Singapore, South Korea, Taiwan, Thailand, Argentina, Bermuda, Brazil, Chile, Colombia, Costa Rica, Israel, Mexico, Puerto Rico, South Africa, and Venezuela.","Z-2221-2013","Class II","OSTEORAPTOR 2.9 mm Suture Anchor with 2 ULTRABRAID Suture, White / Blue ; Part Number: 72201995 Biodegradable suture anchor","50272329 50272466 50274208 50274464 50274790 50275814 50277799 50278266 50278994 50282166 50283019 50283839 50285057 50286656 50288421 50289813 50291359 50293118 50294563 50295608 50296649 50298065 50301017 50302318 50305467 50306821 50308347 50309211 50310089 50310614 50311296 50312591 50314389 50315223 50315419 50316180 50316679 50316987 50317481 50318376 50318532 50319543 50320363 50321935 50323084 50323631 50324184 50324789 50327218 50331339 50333094 50336659 50339177 50340628 50343607 50345140 50345975 50347750 50349688 50352034 50352998 50354277 50354523 50356122 50356984 50357948 50358554 50360002 50360656 50361750 50362641 50363887 50364918 50367858 50368809 50370314 50371912 50374779 50375720 50376835 50377822 50379209 50381376 50384165 50385364 50386748 50387839 50388736 50390940 50392275 50393329 50394520 50395793 50397073 50399277 50400560 50401454 50402073 50403117 50403703 50404630 50406026 50407298 50408207 50408986 50409815 50410646 50411754 50413578 50414258 50415462 50416319 50417212 50418095 50418678 50420659 50422216 50428378 50429372 50429659 50430185 50430406 50433943 50435810 50436716 50437246 50438205 50438744 50440212 50440606 50441444 50443360 50443860 50444062 50445142 50445316 50445551 50445552 50445553 50445555 50445556 50447139 50448325 50449126 50450279 50451524 50452588 50452764 50453646 50454691 50455485 50456543 50458419 50458609 50460107 50460693 50463955 50464113 50465465 50468475 ",,"17696 US","Pinholes detected in a small number of primary pouches that may constitute a breach of the sterile barrier. ",8/6/2013,"08/06/2013",9/25/2013,"09/25/2013"
"Devices",66037,"Ongoing","Smith & Nephew, Inc. Endoscopy Division","Andover","MA","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution - USA (nationwide) Canada, Europe: Austria, Belgium, Cyprus, Czech Republic, Denmark, Germany, Greece, Finland, France, Italy, Ireland, Luxembourg, Netherlands, Norway, Poland, Portugal, Russia, Slovenia, Spain, Sweden, Switzerland, Turkey, Ukraine and United Kingdom, Asia-pacific: Australia, China, Dubai, Hong Kong, India, Japan, Malaysia, New Zealand, Philippines, Sri Lanka, Singapore, South Korea, Taiwan, Thailand, Argentina, Bermuda, Brazil, Chile, Colombia, Costa Rica, Israel, Mexico, Puerto Rico, South Africa, and Venezuela.","Z-2225-2013","Class II","OSTEORAPTOR 2.9 mm Suture Anchor with 2 ULTRABRAID Suture, White / Black; Part Number: 72201996 Biodegradable suture anchor","50272330 50272467 50274209 50274465 50274791 50275815 50277800 50292667 50296071 50302316 50306994 50310605 50311297 50316179 50318681 50321243 50323086 50325048 50325601 50326880 50329010 50329811 50334408 50336660 50338997 50340629 50344015 50346092 50346624 50353156 50354524 50356989 50358564 50363890 50364919 50368628 50370206 50374882 50376601 50378711 50381816 50385513 50390999 50391628 50392410 50395539 50400939 50403274 50404746 50406677 50408208 50409818 50412886 50414333 50415150 50416320 50417391 50418417 50419567 50421499 50431562 50433945 50436052 50437097 50439085 50445036 50445557 50447140 50449470 50450754 50452349 50453811 50454844 50456056 50458436 50461697 ",,"5873 US","Pinholes detected in a small number of primary pouches that may constitute a breach of the sterile barrier. ",8/6/2013,"08/06/2013",9/25/2013,"09/25/2013"
"Devices",66037,"Ongoing","Smith & Nephew, Inc. Endoscopy Division","Andover","MA","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution - USA (nationwide) Canada, Europe: Austria, Belgium, Cyprus, Czech Republic, Denmark, Germany, Greece, Finland, France, Italy, Ireland, Luxembourg, Netherlands, Norway, Poland, Portugal, Russia, Slovenia, Spain, Sweden, Switzerland, Turkey, Ukraine and United Kingdom, Asia-pacific: Australia, China, Dubai, Hong Kong, India, Japan, Malaysia, New Zealand, Philippines, Sri Lanka, Singapore, South Korea, Taiwan, Thailand, Argentina, Bermuda, Brazil, Chile, Colombia, Costa Rica, Israel, Mexico, Puerto Rico, South Africa, and Venezuela.","Z-2240-2013","Class II","TWINFIX Ultra 6.5 mm PLLA-HA Suture Anchor with two #2 ULTRABRAID Sutures (blue, blue-COBRAID) with Needles; Part Number: 72202620 Biodegradable suture anchor","50373721 50375642 50397595 50397598 50397604 50397607 50449548 ",,"314 US","Pinholes detected in a small number of primary pouches that may constitute a breach of the sterile barrier. ",8/6/2013,"08/06/2013",9/25/2013,"09/25/2013"
"Devices",66037,"Ongoing","Smith & Nephew, Inc. Endoscopy Division","Andover","MA","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution - USA (nationwide) Canada, Europe: Austria, Belgium, Cyprus, Czech Republic, Denmark, Germany, Greece, Finland, France, Italy, Ireland, Luxembourg, Netherlands, Norway, Poland, Portugal, Russia, Slovenia, Spain, Sweden, Switzerland, Turkey, Ukraine and United Kingdom, Asia-pacific: Australia, China, Dubai, Hong Kong, India, Japan, Malaysia, New Zealand, Philippines, Sri Lanka, Singapore, South Korea, Taiwan, Thailand, Argentina, Bermuda, Brazil, Chile, Colombia, Costa Rica, Israel, Mexico, Puerto Rico, South Africa, and Venezuela.","Z-2231-2013","Class II","TWINFIX Ultra HA 5.5 mm Suture Anchor with 2 ULTRABRAID Suture, Blue / Black; Part Number: 72202626 Biodegradable suture anchor","50324715 50324960 50326833 50336719 50336768 50339643 50339651 50341854 50344396 50348650 50349838 50350841 50351449 50353295 50360151 50363875 50368586 50372045 50374017 50375716 50378770 50381624 50387868 50390937 50395330 50397700 50402973 50404638 50406692 50408058 50412954 50415137 50416799 50418989 50429269 50429640 50429642 50429832 50431134 50439753 50439754 50442740 50443625 ",,"3827 US","Pinholes detected in a small number of primary pouches that may constitute a breach of the sterile barrier. ",8/6/2013,"08/06/2013",9/25/2013,"09/25/2013"
"Devices",66037,"Ongoing","Smith & Nephew, Inc. Endoscopy Division","Andover","MA","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution - USA (nationwide) Canada, Europe: Austria, Belgium, Cyprus, Czech Republic, Denmark, Germany, Greece, Finland, France, Italy, Ireland, Luxembourg, Netherlands, Norway, Poland, Portugal, Russia, Slovenia, Spain, Sweden, Switzerland, Turkey, Ukraine and United Kingdom, Asia-pacific: Australia, China, Dubai, Hong Kong, India, Japan, Malaysia, New Zealand, Philippines, Sri Lanka, Singapore, South Korea, Taiwan, Thailand, Argentina, Bermuda, Brazil, Chile, Colombia, Costa Rica, Israel, Mexico, Puerto Rico, South Africa, and Venezuela.","Z-2223-2013","Class II","OSTEORAPTOR 2.3 mm Suture Anchor with 1 ULTRABRAID COBRAID Suture, Black; Part Number: 72201992 Biodegradable suture anchor","50272332 50272462 50272750 50274144 50274350 50277105 50278907 50281510 50282171 50282827 50283849 50284637 50285830 50286658 50287767 50289371 50290043 50291934 50292091 50295383 50296070 50297228 50297782 50298793 50300135 50301932 50306856 50307462 50308037 50309210 50310436 50310780 50312090 50313439 50313818 50314915 50315807 50316601 50316986 50317483 50318001 50318687 50319907 50320679 50321916 50322244 50323257 50323630 50323780 50324608 50325611 50326067 50327821 50329242 50331546 50332253 50333092 50334400 50335620 50336405 50338241 50339832 50341062 50341605 50343271 50344262 50344618 50346215 50347305 50349093 50350513 50350978 50352032 50352701 50352997 50353606 50355123 50355672 50356987 50357104 50358206 50359714 50360454 50360914 50361413 50362647 50363190 50364588 50364909 50364915 50370316 50370385 50372675 50372728 50372892 50374025 50374503 50375408 50376044 50376238 50377316 50378706 50380530 50381197 50382647 50384163 50384950 50385362 50387220 50387886 50387896 50388742 50390996 50391608 50392266 50394701 50395538 50397273 50398231 50399415 50400574 50401262 50401918 50402459 50402823 50403367 50403718 50404238 50404920 50405868 50405869 50410769 50412026 50412957 50414254 50416317 50416526 50417204 50418001 50418331 50418992 50421031 50422577 50423435 50423591 50426460 50426933 50427032 50428116 50428624 50429271 50429999 50430000 50430400 50430503 50430504 50430505 50430657 50431379 50433038 50433039 50433040 50433041 50433127 50434653 50435732 50435733 50435734 50435809 50436890 50438659 50440452 50441439 50450277 50450752 50451781 50452210 50452585 50453453 50454295 50454418 50455195 50455483 50455813 50456909 50457385 50458416 50458475 50459739 50460097 50460240 50461060 50462482 50463458 50464108 ",,"18919","Pinholes detected in a small number of primary pouches that may constitute a breach of the sterile barrier. ",8/6/2013,"08/06/2013",9/25/2013,"09/25/2013"
"Devices",66037,"Ongoing","Smith & Nephew, Inc. Endoscopy Division","Andover","MA","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution - USA (nationwide) Canada, Europe: Austria, Belgium, Cyprus, Czech Republic, Denmark, Germany, Greece, Finland, France, Italy, Ireland, Luxembourg, Netherlands, Norway, Poland, Portugal, Russia, Slovenia, Spain, Sweden, Switzerland, Turkey, Ukraine and United Kingdom, Asia-pacific: Australia, China, Dubai, Hong Kong, India, Japan, Malaysia, New Zealand, Philippines, Sri Lanka, Singapore, South Korea, Taiwan, Thailand, Argentina, Bermuda, Brazil, Chile, Colombia, Costa Rica, Israel, Mexico, Puerto Rico, South Africa, and Venezuela.","Z-2227-2013","Class II","OSTEORAPTOR CURVED 2.3 mm Suture Anchor ULTRABRAID COBRAID Suture, Black; Part Number: 72203291 Biodegradable suture anchor","50366964 50366974 50366982 50366987 50366991 50370758 50370941 50370943 50371293 50376477 50387447 50392962 50394696 50397924 50400302 50400308 50408067 50414256 50415787 50417207 50419579 50425118 50428815 50429654 50431732 50435075 50435211 50444669 50445035 50445761 50445877 50450950 50458418 50458435 ",,"4946 US","Pinholes detected in a small number of primary pouches that may constitute a breach of the sterile barrier. ",8/6/2013,"08/06/2013",9/25/2013,"09/25/2013"
"Devices",66037,"Ongoing","Smith & Nephew, Inc. Endoscopy Division","Andover","MA","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution - USA (nationwide) Canada, Europe: Austria, Belgium, Cyprus, Czech Republic, Denmark, Germany, Greece, Finland, France, Italy, Ireland, Luxembourg, Netherlands, Norway, Poland, Portugal, Russia, Slovenia, Spain, Sweden, Switzerland, Turkey, Ukraine and United Kingdom, Asia-pacific: Australia, China, Dubai, Hong Kong, India, Japan, Malaysia, New Zealand, Philippines, Sri Lanka, Singapore, South Korea, Taiwan, Thailand, Argentina, Bermuda, Brazil, Chile, Colombia, Costa Rica, Israel, Mexico, Puerto Rico, South Africa, and Venezuela.","Z-2234-2013","Class II","TWINFIX ULTRA PLLA/HA 5.5 mm Suture Anchor with 3 ULTRABRAID Suture: Part Number: 72202603 Biodegradable suture anchor","50324716 50324717 50326836 50336720 50336769 50337108 50337111 50339644 50339652 50339655 50339836 50340060 50341066 50341289 50341609 50341853 50342712 50344393 50345532 50349940 50375176 50377968 50378734 50380398 50382028 50385516 50386564 50387848 50391713 50392430 50395097 50395980 50396847 50399973 50400923 50402846 50405227 50406208 50406714 50408995 50410652 50411391 50412536 50415225 50415871 50416543 50417398 50428649 50429274 50429621 50429622 50429871 50436765 50436775 50437663 50440391 50443629 50446032 50446451 50446454 50446455 50447009 50447010 50453524 ",,,"Pinholes detected in a small number of primary pouches that may constitute a breach of the sterile barrier. ",8/6/2013,"08/06/2013",9/25/2013,"09/25/2013"
"Devices",66037,"Ongoing","Smith & Nephew, Inc. Endoscopy Division","Andover","MA","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution - USA (nationwide) Canada, Europe: Austria, Belgium, Cyprus, Czech Republic, Denmark, Germany, Greece, Finland, France, Italy, Ireland, Luxembourg, Netherlands, Norway, Poland, Portugal, Russia, Slovenia, Spain, Sweden, Switzerland, Turkey, Ukraine and United Kingdom, Asia-pacific: Australia, China, Dubai, Hong Kong, India, Japan, Malaysia, New Zealand, Philippines, Sri Lanka, Singapore, South Korea, Taiwan, Thailand, Argentina, Bermuda, Brazil, Chile, Colombia, Costa Rica, Israel, Mexico, Puerto Rico, South Africa, and Venezuela.","Z-2226-2013","Class II","OSTEORAPTOR 2.9 mm Suture Anchor with 1 ULTRABRAID Suture, White; Part Number: 72202165 Biodegradable suture anchor","50272335 50272468 50274466 50274792 50275817 50278112 50282209 50283021 50286518 50286657 50286925 50288725 50290551 50291360 50294564 50295956 50296887 50298073 50301797 50307182 50309401 50309926 50310781 50312498 50314440 50319909 50320249 50322931 50323640 50325599 50326068 50329810 50329975 50333958 50335745 50338377 50341064 ",,"4452 US","Pinholes detected in a small number of primary pouches that may constitute a breach of the sterile barrier. ",8/6/2013,"08/06/2013",9/25/2013,"09/25/2013"
"Devices",66037,"Ongoing","Smith & Nephew, Inc. Endoscopy Division","Andover","MA","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution - USA (nationwide) Canada, Europe: Austria, Belgium, Cyprus, Czech Republic, Denmark, Germany, Greece, Finland, France, Italy, Ireland, Luxembourg, Netherlands, Norway, Poland, Portugal, Russia, Slovenia, Spain, Sweden, Switzerland, Turkey, Ukraine and United Kingdom, Asia-pacific: Australia, China, Dubai, Hong Kong, India, Japan, Malaysia, New Zealand, Philippines, Sri Lanka, Singapore, South Korea, Taiwan, Thailand, Argentina, Bermuda, Brazil, Chile, Colombia, Costa Rica, Israel, Mexico, Puerto Rico, South Africa, and Venezuela.","Z-2230-2013","Class II","TWINFIX Ultra HA 4.5 mm Suture Anchor with 2 ULTRABRAID Suture, Blue / Black; Part Number: 72202624 Biodegradable suture anchor","50324708 50325149 50326625 50336717 50337106 50339395 50339843 50341977 50344395 50348067 50349691 50350416 50352028 50353294 50354590 50356630 50358741 50360275 50362293 50363529 50368587 50371455 50374778 50376047 50379205 50382798 50385696 50387871 50388024 50390982 50392404 50395800 50400928 50403699 50405378 50408699 50410783 50415863 50417200 50418988 50429268 50429637 50429638 50429830 50430372 50431221 50438924 50439176 50439782 50440819 50442646 50442874 50446662 50447248 50448829 50449442 50449829 50450460 50451214 50452940 50453996 50456042 50456043 50456044 50456595 50458432 50458472 ",,"6985 US","Pinholes detected in a small number of primary pouches that may constitute a breach of the sterile barrier. ",8/6/2013,"08/06/2013",9/25/2013,"09/25/2013"
"Devices",66037,"Ongoing","Smith & Nephew, Inc. Endoscopy Division","Andover","MA","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution - USA (nationwide) Canada, Europe: Austria, Belgium, Cyprus, Czech Republic, Denmark, Germany, Greece, Finland, France, Italy, Ireland, Luxembourg, Netherlands, Norway, Poland, Portugal, Russia, Slovenia, Spain, Sweden, Switzerland, Turkey, Ukraine and United Kingdom, Asia-pacific: Australia, China, Dubai, Hong Kong, India, Japan, Malaysia, New Zealand, Philippines, Sri Lanka, Singapore, South Korea, Taiwan, Thailand, Argentina, Bermuda, Brazil, Chile, Colombia, Costa Rica, Israel, Mexico, Puerto Rico, South Africa, and Venezuela.","Z-2224-2013","Class II","OSTOSTEORAPTOR 2.9 mm Suture Anchor with 1 ULTRABRAID COBRAID Suture, Blue; Part Number: 72201994 Biodegradable suture anchor","50261490 50270751 50270752 50272328 50272465 50274463 50275816 50277797 50281885 50282824 50284636 50286043 50289368 50294562 50295821 50299025 50302162 50307324 50309971 50315070 50316291 50318787 50321649 50323781 50326576 50327051 50328246 50329605 50330164 50330433 50333202 50333957 50334241 50335882 50338130 50338996 50340050 50340627 50342110 50344240 50347147 50348649 50349265 50352033 50352702 50354093 50355668 50356988 50358386 50358575 50360455 50361180 50364371 50364916 50364917 50367984 50370095 50370386 50372674 50372726 50372891 50374024 50375338 50375718 50381375 50385219 50385825 50387844 50388265 50389117 50389773 50390998 50392274 50392409 50397270 50398235 50399412 50399967 50400564 50401261 50401755 50402841 50403705 50405380 50406766 50407937 50408210 50408987 50412272 50412887 50415149 50415668 50416533 50417385 50418091 50419236 50421032 50423918 50429649 50430508 50431561 50435318 50436414 50437095 50437757 50438661 50439575 50441219 50442379 50444209 50445033 50445549 50445550 50446028 50447137 50448059 50448721 50449649 50449999 50450468 50450949 50452587 50453337 50454420 50455626 50456613 50457636 50458477 50458757 ",,"6373 US","Pinholes detected in a small number of primary pouches that may constitute a breach of the sterile barrier. ",8/6/2013,"08/06/2013",9/25/2013,"09/25/2013"
"Devices",66037,"Ongoing","Smith & Nephew, Inc. Endoscopy Division","Andover","MA","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution - USA (nationwide) Canada, Europe: Austria, Belgium, Cyprus, Czech Republic, Denmark, Germany, Greece, Finland, France, Italy, Ireland, Luxembourg, Netherlands, Norway, Poland, Portugal, Russia, Slovenia, Spain, Sweden, Switzerland, Turkey, Ukraine and United Kingdom, Asia-pacific: Australia, China, Dubai, Hong Kong, India, Japan, Malaysia, New Zealand, Philippines, Sri Lanka, Singapore, South Korea, Taiwan, Thailand, Argentina, Bermuda, Brazil, Chile, Colombia, Costa Rica, Israel, Mexico, Puerto Rico, South Africa, and Venezuela.","Z-2235-2013","Class II","TWINFIX'' Ultra PLLA/HA 6.5 mm with 2 ULTRABRAID'' Suture, White / Black: Part Number: 72202608 Biodegradable suture anchor","50325164 50326837 50336721 50336771 50339645 50339841 50341067 50341975 50344394 50349837 50350415 50351794 50359331 50363876 50368160 50370201 50372046 50375166 50377788 50378916 50380676 50381053 50388605 50392271 50392403 50395799 50403938 50411076 50417379 50422358 50433010 50433121 50438323 50448200 50460082 ",,"1308 US","Pinholes detected in a small number of primary pouches that may constitute a breach of the sterile barrier. ",8/6/2013,"08/06/2013",9/25/2013,"09/25/2013"
"Devices",66037,"Ongoing","Smith & Nephew, Inc. Endoscopy Division","Andover","MA","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution - USA (nationwide) Canada, Europe: Austria, Belgium, Cyprus, Czech Republic, Denmark, Germany, Greece, Finland, France, Italy, Ireland, Luxembourg, Netherlands, Norway, Poland, Portugal, Russia, Slovenia, Spain, Sweden, Switzerland, Turkey, Ukraine and United Kingdom, Asia-pacific: Australia, China, Dubai, Hong Kong, India, Japan, Malaysia, New Zealand, Philippines, Sri Lanka, Singapore, South Korea, Taiwan, Thailand, Argentina, Bermuda, Brazil, Chile, Colombia, Costa Rica, Israel, Mexico, Puerto Rico, South Africa, and Venezuela.","Z-2232-2013","Class II","TWINFIX Ultra HA 6.5 mm with 2 ULTRABRAID Suture, Blue / Black; Part Number: 72202631 Biodegradable suture anchor","50325165 50326838 50336722 50339646 50339844 50343443 50350417 50352981 50379206 50397701 50429644 ",,"708 US","Pinholes detected in a small number of primary pouches that may constitute a breach of the sterile barrier. ",8/6/2013,"08/06/2013",9/25/2013,"09/25/2013"
"Devices",66037,"Ongoing","Smith & Nephew, Inc. Endoscopy Division","Andover","MA","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution - USA (nationwide) Canada, Europe: Austria, Belgium, Cyprus, Czech Republic, Denmark, Germany, Greece, Finland, France, Italy, Ireland, Luxembourg, Netherlands, Norway, Poland, Portugal, Russia, Slovenia, Spain, Sweden, Switzerland, Turkey, Ukraine and United Kingdom, Asia-pacific: Australia, China, Dubai, Hong Kong, India, Japan, Malaysia, New Zealand, Philippines, Sri Lanka, Singapore, South Korea, Taiwan, Thailand, Argentina, Bermuda, Brazil, Chile, Colombia, Costa Rica, Israel, Mexico, Puerto Rico, South Africa, and Venezuela.","Z-2229-2013","Class II","TWINFIX Ultra HA 4.5 mm Suture Anchor with 2 ULTRABRAID Suture, White / Blue; Part Number: 72202597 Biodegradable suture anchor","50324706 50324707 50324958 50325148 50326624 50336118 50336716 50336759 50337105 50337109 50337112 50339394 50339648 50339653 50339656 50339873 50341613 50343278 50344410 50346095 50350419 50352199 50357080 50358106 50358736 50359998 50361739 50362786 50363871 50366812 50368582 50370504 50372042 50374257 50376594 50378774 50380528 50382637 50384518 50386924 50388022 50390005 50390988 50392388 50395082 50395975 50396667 50398098 50401255 50402220 50404745 50406626 50406675 50408537 50411606 50414330 50415861 50417004 50418086 50422213 50428616 50429266 50429632 50436702 50436747 50436748 50438319 50438651 50438735 50438739 50438918 50445013 50446067 50446068 50446460 50446995 50448591 50450274 50451213 50453452 50453995 50456041 50456190 50457051 50458600 50462057 ",,"8889 US","Pinholes detected in a small number of primary pouches that may constitute a breach of the sterile barrier. ",8/6/2013,"08/06/2013",9/25/2013,"09/25/2013"
"Devices",66037,"Ongoing","Smith & Nephew, Inc. Endoscopy Division","Andover","MA","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution - USA (nationwide) Canada, Europe: Austria, Belgium, Cyprus, Czech Republic, Denmark, Germany, Greece, Finland, France, Italy, Ireland, Luxembourg, Netherlands, Norway, Poland, Portugal, Russia, Slovenia, Spain, Sweden, Switzerland, Turkey, Ukraine and United Kingdom, Asia-pacific: Australia, China, Dubai, Hong Kong, India, Japan, Malaysia, New Zealand, Philippines, Sri Lanka, Singapore, South Korea, Taiwan, Thailand, Argentina, Bermuda, Brazil, Chile, Colombia, Costa Rica, Israel, Mexico, Puerto Rico, South Africa, and Venezuela.","Z-2239-2013","Class II","TWINFIX Ultra 5.5 mm PLLA-HA Suture Anchor with two #2 ULTRABRAID Sutures (blue, blue-COBRAID) with Needles; Part Number: 72202616 Biodegradable suture anchor","50373722 50397580 50397597 50397602 50397606 50414780 50418109 50431745 50431893 50432157 50438518 50438520 50447115 50447117 50447120 50448228 50449526 50449671 50450004 50454012 50454109 50456362 50459638 50460185 50462233 50468656 50469160 50469533 ",,"2038 US","Pinholes detected in a small number of primary pouches that may constitute a breach of the sterile barrier. ",8/6/2013,"08/06/2013",9/25/2013,"09/25/2013"
"Devices",66037,"Ongoing","Smith & Nephew, Inc. Endoscopy Division","Andover","MA","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution - USA (nationwide) Canada, Europe: Austria, Belgium, Cyprus, Czech Republic, Denmark, Germany, Greece, Finland, France, Italy, Ireland, Luxembourg, Netherlands, Norway, Poland, Portugal, Russia, Slovenia, Spain, Sweden, Switzerland, Turkey, Ukraine and United Kingdom, Asia-pacific: Australia, China, Dubai, Hong Kong, India, Japan, Malaysia, New Zealand, Philippines, Sri Lanka, Singapore, South Korea, Taiwan, Thailand, Argentina, Bermuda, Brazil, Chile, Colombia, Costa Rica, Israel, Mexico, Puerto Rico, South Africa, and Venezuela.","Z-2222-2013","Class II","OSTEORAPTOR 2.3 mm with 1 ULTRABRAID Suture, White; Part Number: 72201991 Biodegradable suture anchor","50272333 50272460 50272749 50273092 50274145 50274574 50277104 50277531 50278113 50281660 50283022 50283200 50283850 50285450 50287132 50290044 50290336 50292248 50293720 50295817 50298408 50301689 50302077 50305597 50307616 50307617 50307618 50307663 50308924 50308925 50308926 50309406 50309508 50310779 50311755 50312497 50314731 50316178 50316439 50317760 50318970 50320251 50320672 50321643 50321930 50322929 50324017 50325608 50326698 50327820 50329812 50331690 50332905 50334815 50336529 50339426 50340626 50341618 50343004 50343606 50344261 50344616 50346627 50350512 50351012 50351958 50353154 50353603 50354094 50355980 50356986 50358573 50359120 50360006 50360806 50361757 50362646 50363764 50364908 50364913 50364914 50370384 50372334 50372727 50372893 50374260 50375049 50375595 50378705 50378911 50379639 50380393 50380529 50383897 50384594 50385078 50385697 50387883 50388027 50388266 50389118 50390497 50392265 50394521 50395089 50395537 50397272 50397703 50399280 50400568 50401030 50401758 50402612 50403120 50403717 50404750 50405222 50406196 50407002 50407567 50407939 50408700 50409823 50411054 50412275 50413141 50414235 50415253 50415494 50416128 50416525 50417009 50417383 50418000 50418498 50419235 50421349 50423113 50423434 50425116 50426665 50426939 50427505 50429270 50430180 50431376 50433037 50433126 50434434 50435065 50435511 50438086 50438658 50439570 50440210 50441218 50442032 50444061 50444660 50445139 50445312 50445544 50445545 50446349 50447136 50448057 50449021 50449978 50449979 50449981 50449983 50449984 50449985 50450604 50450947 50451941 50452039 50453146 50453803 50454293 50454688 50455482 50455623 50456054 50456340 50456908 50458605 50460096 50460239 50461691 50462794 50463457 50466682 ",,"22879 US","Pinholes detected in a small number of primary pouches that may constitute a breach of the sterile barrier. ",8/6/2013,"08/06/2013",9/25/2013,"09/25/2013"
"Devices",66037,"Ongoing","Smith & Nephew, Inc. Endoscopy Division","Andover","MA","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution - USA (nationwide) Canada, Europe: Austria, Belgium, Cyprus, Czech Republic, Denmark, Germany, Greece, Finland, France, Italy, Ireland, Luxembourg, Netherlands, Norway, Poland, Portugal, Russia, Slovenia, Spain, Sweden, Switzerland, Turkey, Ukraine and United Kingdom, Asia-pacific: Australia, China, Dubai, Hong Kong, India, Japan, Malaysia, New Zealand, Philippines, Sri Lanka, Singapore, South Korea, Taiwan, Thailand, Argentina, Bermuda, Brazil, Chile, Colombia, Costa Rica, Israel, Mexico, Puerto Rico, South Africa, and Venezuela.","Z-2238-2013","Class II","TWINFIX'' Ultra 4.5 mm PLLA-HA Suture Anchor with two #2 ULTRABRAID Sutures (blue, blue-COBRAID'') with Needles; Part Number: 72202612 Biodegradable suture anchor","50373723 50389654 50389655 50397577 50397596 50397599 50397605 50417226 50431744 50431853 50433695 50437528 50440608 50441690 50447116 50447118 50447119 50448227 50454009 50454867 50461412 50467503 50469159 50470653 ",,"1571 US","Pinholes detected in a small number of primary pouches that may constitute a breach of the sterile barrier. ",8/6/2013,"08/06/2013",9/25/2013,"09/25/2013"
"Devices",66037,"Ongoing","Smith & Nephew, Inc. Endoscopy Division","Andover","MA","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution - USA (nationwide) Canada, Europe: Austria, Belgium, Cyprus, Czech Republic, Denmark, Germany, Greece, Finland, France, Italy, Ireland, Luxembourg, Netherlands, Norway, Poland, Portugal, Russia, Slovenia, Spain, Sweden, Switzerland, Turkey, Ukraine and United Kingdom, Asia-pacific: Australia, China, Dubai, Hong Kong, India, Japan, Malaysia, New Zealand, Philippines, Sri Lanka, Singapore, South Korea, Taiwan, Thailand, Argentina, Bermuda, Brazil, Chile, Colombia, Costa Rica, Israel, Mexico, Puerto Rico, South Africa, and Venezuela.","Z-2233-2013","Class II","TWINFIX Ultra PLLA/HA 5.5 mm Suture Anchor with 2 ULTRABRAID Suture, White / Black: Part Number: 72202602 Biodegradable suture anchor","50324714 50324959 50325405 50336718 50336766 50337107 50337110 50339396 50339650 50339654 50339835 50340055 50341065 50341288 50341608 50341852 50341974 50343277 50344392 50345531 50346096 50349836 50350192 50351792 50355983 50356629 50357082 50358377 50358556 50359999 50360659 50361740 50362632 50363174 50363872 50366312 50367556 50368583 50369516 50370078 50370505 50371296 50371908 50372043 50372901 50373581 50376024 50376595 50377415 50378045 50378652 50379636 50379935 50381013 50381052 50382145 50383363 50384738 50384957 50385695 50388023 50388427 50388915 50390006 50390936 50391241 50391607 50392270 50392402 50394175 50394700 50395079 50395329 50395678 50396196 50397457 50399965 50400926 50401256 50402972 50403490 50404762 50405432 50405695 50406373 50406776 50407574 50410247 50410909 50411608 50413138 50413770 50414757 50415220 50415662 50416307 50416797 50417199 50417996 50420510 50421494 50421722 50429267 50429347 50429634 50429635 50430369 50433008 50433009 50433120 50433338 50438321 50438322 50438923 50438981 50438982 50440714 50441083 50444410 50446345 50446447 50446997 50448199 50449437 50449827 50450459 50450942 50451511 50451937 50456336 50457052 50457924 50458755 50459278 50459634 50459731 50462225 50467497 ",,"7148 US","Pinholes detected in a small number of primary pouches that may constitute a breach of the sterile barrier. ",8/6/2013,"08/06/2013",9/25/2013,"09/25/2013"
"Devices",66037,"Ongoing","Smith & Nephew, Inc. Endoscopy Division","Andover","MA","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution - USA (nationwide) Canada, Europe: Austria, Belgium, Cyprus, Czech Republic, Denmark, Germany, Greece, Finland, France, Italy, Ireland, Luxembourg, Netherlands, Norway, Poland, Portugal, Russia, Slovenia, Spain, Sweden, Switzerland, Turkey, Ukraine and United Kingdom, Asia-pacific: Australia, China, Dubai, Hong Kong, India, Japan, Malaysia, New Zealand, Philippines, Sri Lanka, Singapore, South Korea, Taiwan, Thailand, Argentina, Bermuda, Brazil, Chile, Colombia, Costa Rica, Israel, Mexico, Puerto Rico, South Africa, and Venezuela.","Z-2218-2013","Class II","BIORAPTOR 2.9 mm Suture Anchor Straight, pack of 2 ULTRABRAID Suture; Part Number: 72200690 Biodegradable suture anchor","50253115 50253116 50253563 50258921 50259836 50261046 50261482 50266078 50266098 50266396 50266957 50270377 50271281 50273022 50274567 50281658 50291542 50293283 50298902 50302160 50304442 50308346 50310770 50323628 50328862 50348760 50349091 50350411 50353298 50359945 50360003 50361170 50361752 50364587 50366305 50380819 50382582 50386154 50387219 50387852 50388184 50388737 50389115 50389772 50417524 50452589 50464571 ",,"725 US","Pinholes detected in a small number of primary pouches that may constitute a breach of the sterile barrier. ",8/6/2013,"08/06/2013",9/25/2013,"09/25/2013"
"Devices",66037,"Ongoing","Smith & Nephew, Inc. Endoscopy Division","Andover","MA","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution - USA (nationwide) Canada, Europe: Austria, Belgium, Cyprus, Czech Republic, Denmark, Germany, Greece, Finland, France, Italy, Ireland, Luxembourg, Netherlands, Norway, Poland, Portugal, Russia, Slovenia, Spain, Sweden, Switzerland, Turkey, Ukraine and United Kingdom, Asia-pacific: Australia, China, Dubai, Hong Kong, India, Japan, Malaysia, New Zealand, Philippines, Sri Lanka, Singapore, South Korea, Taiwan, Thailand, Argentina, Bermuda, Brazil, Chile, Colombia, Costa Rica, Israel, Mexico, Puerto Rico, South Africa, and Venezuela.","Z-2216-2013","Class II","BIORAPTOR 2.9 mm Suture Anchor with 1 ULTRABRAID Suture; Part Number: 72200774 Biodegradable suture anchor","50252956 50253511 50255944 50257231 50257887 50258391 50259146 50259750 50259821 50260686 50261428 50262956 50263219 50263661 50264102 50265258 50266339 50266927 50267570 50268569 50269026 50269813 50270372 50271272 50271909 50272355 50273934 50274664 50275118 50276255 50276806 50277167 50277785 50278253 50278900 50279470 50280271 50280510 50281120 50281481 50281875 50282158 50282541 50283320 50283827 50285048 50285421 50286293 50286609 50287487 50287743 50288414 50288712 50289363 50290038 50290548 50291351 50292241 50293608 50294169 50294378 50295261 50297038 50298069 50299385 50299683 50300671 50301473 50302325 50303059 50303150 50303787 50304658 50305102 50305723 50306820 50307460 50308223 50308654 50309005 50309760 50309927 50310434 50310774 50310860 50311917 50312590 50314382 50315219 50315411 50315799 50316169 50316263 50316662 50316990 50317055 50317280 50317454 50317458 50317464 50317995 50318784 50319133 50319545 50320231 50321239 50323634 50324606 50325731 50326560 50327214 50328866 50330833 50331688 50332902 50333546 50333779 50338800 50339831 50341603 50342909 50344379 50345301 50345318 50346210 50348330 50348512 50349830 50350260 50350691 50351144 50351956 50352210 50353153 50353605 50354092 50354530 50355121 50356403 50356622 50357089 50357390 50358104 50358384 50358570 50358737 50360444 50360805 50361888 50362229 50363185 50363892 50364660 50364943 50366146 50366306 50367859 50369187 50370318 50370807 50371620 50372061 50372503 50372895 50373328 50375326 50376603 50378048 50378139 50379043 50381196 50382147 50385218 50385487 50385823 50386382 50388029 50388738 50388904 50390494 50391246 50392389 50394523 50395091 50396670 50398546 50399426 50401028 50402074 50402820 50404404 50405090 50405697 50405889 50409820 50407935 50408209 50410766 50411053 50411900 50412271 50413139 50414779 50414982 504154",,"24574 US","Pinholes detected in a small number of primary pouches that may constitute a breach of the sterile barrier. ",8/6/2013,"08/06/2013",9/25/2013,"09/25/2013"
"Devices",66037,"Ongoing","Smith & Nephew, Inc. Endoscopy Division","Andover","MA","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution - USA (nationwide) Canada, Europe: Austria, Belgium, Cyprus, Czech Republic, Denmark, Germany, Greece, Finland, France, Italy, Ireland, Luxembourg, Netherlands, Norway, Poland, Portugal, Russia, Slovenia, Spain, Sweden, Switzerland, Turkey, Ukraine and United Kingdom, Asia-pacific: Australia, China, Dubai, Hong Kong, India, Japan, Malaysia, New Zealand, Philippines, Sri Lanka, Singapore, South Korea, Taiwan, Thailand, Argentina, Bermuda, Brazil, Chile, Colombia, Costa Rica, Israel, Mexico, Puerto Rico, South Africa, and Venezuela.","Z-2237-2013","Class II","RAPTORMITE'' 3.7 mm PLLA with two ULTRABRAID'' Sutures Size 0 and Needles; Part Number: 72201805 Biodegradable suture anchor","50268918 50273148 50273920 50275809 50275812 50282175 50291658 50293289 50296525 50296650 50298707 50305798 50305840 50312502 50312528 50314834 50340632 50343203 50349591 50351817 50358580 50371915 50376235 50387881 50390367 50394081 50396639 50396640 50396641 50399818 50403721 50405089 50412292 50415521 50416545 50418333 50445533 50447145 50454703 50456549 50460175 50460177 50461710 50469565 ",,"1965 US","Pinholes detected in a small number of primary pouches that may constitute a breach of the sterile barrier. ",8/6/2013,"08/06/2013",9/25/2013,"09/25/2013"
"Biologics",66038,"Terminated","San Diego Blood Bank","San Diego","CA","US","Voluntary: Firm Initiated","Telephone","California","B-0066-14","Class III","Red Blood Cells Leukocytes Reduced","W044213851348; W044213851352; W044213851381; W044213851355; W044213851363; W044213851366; W044213851370; W044213851373; W044213851374; W044213851377; W044213851384; ",".","11 units","Red Blood Cells, not manufactured in compliance with the firm's quality control specifications were distributed.",7/26/2013,"07/26/2013",12/11/2013,"12/11/2013"
"Biologics",66039,"Terminated","American Red Cross Blood Services Tennessee Valley Region","Nashville","TN","US","Voluntary: Firm Initiated","FAX","Tennessee","B-0065-14","Class II","Red Blood Cells Leukocytes Reduced","019GR80541",".","1 component","Red Blood Cells, mislabeled as S antigen negative, was distributed. ",6/20/2013,"06/20/2013",12/11/2013,"12/11/2013"
"Devices",66040,"Ongoing","Insight Instruments, Inc.","Stuart","FL","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution - USA (nationwide) including AZ, CA, FL, IN, MA, MD, TX, and WA and Internationally to Czech Republic, Germany, Netherlands, Spain, Switzerland, and Turkey.","Z-0144-2014","Class II","MLS Torpedo Mini-Light Ophthalmic single-port illumination. Sutureless 25- gauge illuminator for vitreo-retinal surgery when full field illumination of bimanual surgery if desired.","Part Number Lot Number Expiration 11007 M52934 04/2013 11017 M53017 04/2013 11007 M55285 07/2013 11007 M55869 08/2013 11007 M58610 12/2013 11007 M59575 02/2014 11007 M61781 05/2014 ",".","10212","The product was registered and distributed as a Class I medical device and was subsequently determined to be a Class II medical device which requires FDA market clearance.",6/27/2013,"06/27/2013",11/13/2013,"11/13/2013"
"Veterinary",66042,"Ongoing","Wedgewood Village Pharmacy, Inc.","Swedesboro","NJ","US","Voluntary: Firm Initiated","Telephone","Nationwide","V-312-2013","Class II","Pentosan Polysulfate Sodium (K9) 150 mg/ml aqueous solution for injection, for Veterinary Use only 10 mL Sterile amber vials Refrigerated Storage required. Item Code PENTOS-INJ007VC This preparation is dispensed with a prescription label, so each vial would be individually labeled with specific information containing not only the drug name, strength, etc. but also the patient name, prescriber name, and directions for use.","Lot number 20130618@409, Beyond Use Date 12/15/2013",".","34 units","Routine endotoxin testing of this batch indicated that the finished injection solution contained a concentration of endotoxins exceeding established endotoxin concentration limits. A second sample tested from this same lot confirmed the higher than expected endotoxin concentration.",6/28/2013,"06/28/2013",9/11/2013,"09/11/2013"
"Drugs",66043,"Ongoing","Fabscout Entertainment, Inc","Ft Lauderdale","FL","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","CA, FL and UT","D-377-2014","Class I","72HP MAXIMUM POTENCY MALE SEXUAL ENHANCEMENT, Dietary Supplement, supplied in 1 capsule per blister pack, Distributed by: 72HP, Inc. Weston, FL ","All Lots",".","578 blister packs of 1 capsule each","Marketed without an Approved NDA/ANDA: products were found to contain undeclared sildenafil",8/14/2013,"08/14/2013",12/26/2013,"12/26/2013"
"Drugs",66043,"Ongoing","Fabscout Entertainment, Inc","Ft Lauderdale","FL","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","CA, FL and UT","D-378-2014","Class I","PRO POWER MAX Natural Energy Enhancer, ALL NATURAL HERBS, supplied in 1 capsule per blister pack, Distributed by MSH Distribution LLC ","All Lots",".","18 blister packs of one capsule each","Marketed without an Approved NDA/ANDA: product found to contain undeclared sildenafil and tadalafil",8/14/2013,"08/14/2013",12/26/2013,"12/26/2013"
"Drugs",66043,"Ongoing","Fabscout Entertainment, Inc","Ft Lauderdale","FL","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","CA, FL and UT","D-376-2014","Class I","Evil Root 1200 mg, supplied in 6 capsules per bottle, Manufacturer: Tibet Shengyang Health Medicine Co.,Ltd. Address: No. 98, Min zu Road, Lhasa","All Lots",".","32 bottles of 6 capsules each","Marketed without an Approved NDA/ANDA: product found to contain undeclared sildenafil",8/14/2013,"08/14/2013",12/26/2013,"12/26/2013"
"Devices",66046,"Ongoing","Cardiogenesis Corporation","Kennesaw","GA","US","Voluntary: Firm Initiated","Letter","US Distribution","Z-1993-2013","Class II","Cardiogenesis Corporation - Cardiogenesis Transmyocardial Laser. The device is indicated for use in the treatment of patients with angina (Canadian Cardiovascular Society Class 4) refractory to medical treatment and secondary to objectively demonstrated coronary artery atherosclerosis and with a region of the myocardium with reversible ischemia not amenable to direct coronary revascularization.","Product Code - HP-SG3 Product Code -HP-PRL5",".","2498"," Following acquisition of Cardiogenesis, we began receiving complaints of sparks, burns, or smoke incidents related to the handpieces.",5/1/2011,"05/01/2011",9/18/2013,"09/18/2013"
"Devices",66047,"Ongoing","Abbott Laboratories, Inc","Irving","TX","US","Voluntary: Firm Initiated","Letter","Worldwide distribution: US (nationwide) including Puerto Rico and countries of: Albania, Algeria, Argentina, Austria, Australia, Azerbaijan, Bangladesh, Bahamas, Belgium, Bosnia & Herzegovina, Brazil, Bulgaria, Burkina, Canada, Cayman Islands, Chile, China, Columbia, Croatia, Curacao, Cyprus, Czech Republic, Denmark, Dominican Republic, El Salvador, Egypt, Estonia, Ethiopia, Finland, France, Germany, Greece, Guatemala, Hong Kong, India, Iraq, Ireland, Israel, Italy, Ivory Coast, Jamaica, Jordan, Kazakhstan, Kenya, Kuwait, Latvia, Lebanon, Libya, Lithuania, Luxembourg, Malaysia, Mali, Mauritania ,Mexico, Moldova, Morocco, Netherlands, New Zealand, Norway, Oman, Pakistan, Panama, Paraguay, Philippines, Poland, Portugal, Qatar, Republic of Yemen, Romania, Russia, Saudi Arabia, Senegal, Serbia, Singapore, Slovakia, Slovenia, South Africa, South Korea, Spain, Sweden, Switzerland, Tajikistan, Taiwan, Tanzania, Thailand, Trinidad & Tobago, Tunisia, Turkey, Turks and Caicos, United Arab Emirates, United Kingdom, Uruguay and Vietnam.","Z-0020-2014","Class II","Clinical Chemistry Phosphorus Reagent The Phosphorus assay is used for the quantitation of phosphorus in human serum, plasma, or urine.","For List Number: 7D71-22, Lot Numbers 64736UN12 (Exp Date on Label is 14 JAN 2014), 03991UN13 (Exp Date on Label is 01 APR 2014), and 51611UN13 (Exp Date on Label is 13 JUL 2014). For List Number: 7D71-31, Lot Numbers 74805UN12 (Exp Date on Label is 14 JAN 2014) and 03992UN13 (Exp Date on Label is 01 APR 2014).",,"7213","Reagent lots 64736UN12, 03991UN13, 51611UN13, 74805UN12, and 03992UN13 have incorrect expiration dates assigned by Supplier.",8/12/2013,"08/12/2013",10/23/2013,"10/23/2013"
"Devices",66048,"Ongoing","Elekta, Inc.","Atlanta","GA","US","Voluntary: Firm Initiated","Letter","Nationwide distribution: AL, CT, FL, GA, IA, MS, MO, NJ, NY, ND, OH, OK, PA, RI, TX, VA and Puerto Rico.","Z-2157-2013","Class II","DMLC IV-ERGO - Beam shaping block for Radiation Therapy.","EM-042, EM7-004, EM-046, EM-060, EM-047, EM-029, EM7-003, EM7-002, EM7-008, EM-062, EM-063, EM3-004, 116001, 116012, 116044, 116055, 116014, 116052, 116023, 116056, 116053, 116043, 116047, 116051, 116122, 116068, 116013, 116046",".","31","Clinical mistreatment may occur when there are errors in the clinical work flow.",8/15/2013,"08/15/2013",9/11/2013,"09/11/2013"
"Devices",66049,"Ongoing","Maquet Cardiovascular Us Sales, Llc","Wayne","NJ","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution, including Nationwide (US) and foreign countries.","Z-2262-2013","Class II","QUADROX iD HMOD 2030 Diffusion Membrane Oxygenator; QUADROX-i ADULT HMO 70000 / HMO 71000; QUADROX-iD Pediatric HMOD 30000. The QUADROX oxygenators are intended for use in extracorporeal circulation during cardiopulmonary bypass in cardiac surgery. ","QUADROX-iD Adult catalog number HMOD 70000, lot # 70081567 QUADROX-i Adult catalog number VKMO 70000, lot # 70082663 QUADROX-i Adult catalog number VKMO 71000, lot # 70083974 ",".","1,182 units","The manufacturer has conducted a review of the results of product testing performed during the last twelve months and has identified specific lots of product which may not meet specifications for bond strength on the inlet and/or outlet connector.",8/15/2013,"08/15/2013",10/2/2013,"10/02/2013"
"Drugs",66050,"Ongoing","Hospira, Inc.","Lake Forest","IL","US","Voluntary: Firm Initiated","Letter","Naitonwide","D-926-2013","Class II","Ketorolac Tromethamine Inj., USP, 30 mg vial, Rx only, Hospira, Inc., Lake Forest, IL 60045 USA, NDC 0409-3795-01","Lot 25048DK Exp. 01/15",,"345,800 vials","Lack of Assurance of Sterility: Either a loose crimp or no crimp was applied to the fliptop vials.",8/12/2013,"08/12/2013",9/4/2013,"09/04/2013"
"Devices",66051,"Ongoing","Maquet Cardiovascular Us Sales, Llc","Wayne","NJ","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution - USA including NY and PA and internationally to Australia, Brazil, Canada, Germany, Hong Kong, Japan, Sweden.","Z-2275-2013","Class II","TEGRIS system Four labels of the Tegris System include: Emergency button (1703.72) MAQUET GmbH & Co. KG Kehler-Strabe 31 Baden-Wuerttemberg 76437 Rastatt, Germany Touch screen (elo) Elo TouchSystems 301 Constitution Drive Menlo Park, CA 94025 www.elotouch.com Manufacturer: Tyco Electronics Brand Name: Elo Touch Systems Made in China Tegris system (1703.01) MAQUET GmbH & Co. KG Kehler Strabe 31 76437 Rastatt, Germany OR Table Module (1703.71) MAQUET GmbH & Co. KG Kehler Strabe 31 Baden-Wuerttemberg 76437 Rastatt, Germany Designed to be used as the central operating system in an operating room. The integration system has two main functions. -recording and distribution of images and videos -interaction with medical and non-medical devices. The system has a modular design and comprises the basic units as well as s various optional modules,which may be used or integrated in conjunction with the basic unit. TEGRIS is operated using a touchscreen. Medical devices that can be operated by TEGRIS include OR tables an OR lights. In the case of OR tables and OR lights, the main functions of these devices may be separated, e.g. adjustment of OR tables or switching the OR lights on.off. TEGRIS has no effected on the primary operating functions of the original control device. TEGRIS does not provide any other functions in addition to these primary operating functions. The purpose of TEGRIS namely the central operation of these various devices, is dependant on the individual devices. Please refer to the operating instructions of the individual devices for instructions. The integrated surgical safety checklist is a raft and must be modified to meet local requirements and approved by the User. TEGRIS is intended for short-term use pursuant to Appendix IX of the Directive 93/42/EEC of medical products in medical rooms in accordance with Group 1 and 2 VDR 0100-710, providing, among other things, protection against electric shock and connections for potential equalization lines. Intende","Class 1 exempt Device Listing #D122038 Tegris Base System 1703.01X0 OR TAblet Module 1703.71A0 Secondary 19'' touchscreen - part number 1707.05A0 The above product is affected only when used in combination with Tegris base system 1703.01X0 OR Table Control 1703.71A0",".","21 units","MAQUET has identified a potential issue that might occur because of the lack of an emergency stop button on a secondary touch screen display on the TEGRIS System. ",8/19/2013,"08/19/2013",10/2/2013,"10/02/2013"
"Devices",66052,"Ongoing","3M Company - Health Care Business","Saint Paul","MN","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution - USA including AL, AZ, AR, CA, CO,CT, FL, GA, HI, IL, IN,KS,KY, LA, MD, MA, MI, MN, MO, NE, NV, NJ, NY, NC, OH, OR,PA, TN, TX, UT,VA, WA, and WI. Internationally to GERMANY, CANADA, BELGIUM, NETHERLANDS, HONG KONG, NEW ZEALAND, AUSTRALIA, INDIA, KOREA, SINGAPORE AND UNITED ARAB EMIRATES, JAPAN, JAMAICA..","Z-2242-2013","Class II","3M Scotchcast, Wet or Dry Cast Padding, Catalog Numbers WDP2, WDP3, WDP4, and WDP6. Intended for use in constructing casts for either wet or dry immobilization.","Catalog # - Lot # WDP2 - 792920, 793090, 793640 & 796078. WDP3 - 792921, 793098, 793638, 796077 & 798487. WDP4 - 792922, 793116, 793637, 796079 & 798488. WDP6 792923, 793636, 798489, 799235 & 799236 ",,"1207 cases (4 puches per case, 20 rolls per pouch)","3M is conducting a voluntary product recall of selected lots of 3M'' Scotchcast'' Wet or Dry Cast Padding. Upon investigation of a health care provider feedback, and confirmed with internal testing, it was found that the cast padding material does not consistently repel water. Lack of repellency may result in prolonged cast dry times after exposure to wet conditions. There have been no reports of patient injury associated with this material to date. ",8/5/2013,"08/05/2013",9/25/2013,"09/25/2013"
"Food",66053,"Ongoing","Hartleys Potato Chip Company Inc","Lewistown","PA","US","Voluntary: Firm Initiated","Letter","Pennsylvania only.","F-0001-2014","Class I","Hartley's Potato Chips Salt & Vinegar 4.5 oz and 2.5 oz bags Hartley's Potato Chip Co., Inc, Lewistown, PA Ingredients: potatoes, vegetable shortening, salt, lactose, sodium diacetate, salt, malic acid, sodium citrate, with not more than 2% silicon dioxide and partially hydrogenated soybean and/or cottonseed oil. ","Sell by Dates: Oct 7 2013 and Oct 30 2013",,"4549 bags; 722 lb.","Undeclared lactose (milk) in seasoning sub-ingredient used in the manufacturing of Hartley's Salt & Vinegar Potato Chips. ",8/20/2013,"08/20/2013",10/23/2013,"10/23/2013"
"Drugs",66054,"Ongoing","Actavis South Atlantic LLC","Sunrise","FL","US","Voluntary: Firm Initiated","Letter","Nationwide and Puerto Rico","D-917-2013","Class III","buPROPion Hydrochloride Extended-Release Tablets (XL), 300 mg, 30-count tablets per bottle, Rx only, Distributed by: Actavis South Atlantic, LLC, Sunrise, FL 33325; Packaged by: American Health Packaging, Columbus, OH 43217, NDC 67767-142-30, UPC 3 67767-142-30 6.","Lot #: CA2D14A, CA2D15A, Exp 12/13; CD2D07A, CD2D09A, CD2D10A, CD2D09B, CD2D08A, Exp 03/14; CE2D05A, CE2D06A, CE2D07A, CE2D11A, CE2D12A, CE2D10A, CE2D19A, Exp 04/14; CF2D01A, CF2D02A, CF2D03A, Exp 05/14; CG2D04A, CG2D05A, CG2D07A, CG2D09A, CG2D12A, CG2D12A, Exp 06/14; CH2D13A, CH2D14A, CH2D17A, CH2D18A, CH2D21A, Exp 07/14; CJ2D10A, CJ2D11A, Exp 08/14",,"428,268 bottles","Failed Dissolution Specifications: This recall is an extension of the recall initiated on 07/31/2013 for Bupropion HCl Extended-Release Tablets (XL) 300 mg, because another lot was shown to have similar failing results for dissolution at the 8-hour timepoint.",8/21/2013,"08/21/2013",9/4/2013,"09/04/2013"
"Devices",66056,"Ongoing","Ergosafe Products LLC DBA Prism Medical Services USA","Maryland Heights","MO","US","Voluntary: Firm Initiated","E-Mail","Nationwide distribution.","Z-0370-2014","Class II","Medcare Products Max-500 Stand, Total Support, patient stand, model #400006. The responsible firm name listed in the Operations Manual is Medcare Products, Burnsville, MN. Used for assisting patients/residents to a standing position.","Serial numbers 0109STH0042, 0112STH0085, 0112STH0086, 0112STH0087, 0112STH0089, 0112STH0090, 0112STH0091, 0112STH0092, 1211STH0071, 0207STH0003, 0207STH0004, 0209STH0043, 0211STH0072, 0212STH0093, 0212STH0094, 0212STH0095, 0212STH0096, 0212STH0097, 0212STH0098, 0212STH0099, 0212STH0100, 0308STH0027, 0308STH0028, 0308STH0029, 0308STH0030, 0309STH0044, 0309STH0045, 0309STH0046, 0407STH0005, 0409STH0047, 0507STH0006, 0508STH0031, 0508STH0032, 0510STH0058, 0510STH0059, 0510STH0060, 0511STH0073, 0511STH0074, 0607STH0007, 0608STH0033, 0608STH0034, 0609STH0049, 0610STH0061, 0610STH0062, 0610STH0063, 0610STH0064, 0611STH0075, 0611STH0076, 0611STH0077, 0613STH0113, 0613STH0114, 0613STH0115, 0613STH0116, 0613STH0117, 0613STH0118, 0707STH0008, 0708STH0035, 0708STH0036, 0709STH0050, 0709STH0051, 0710STH0065, 0711STH0078, 0711STH0079, 0711STH0080, 0712STH0101, 0712STH0102, 0712STH0103, 0712STH0104, 0809STH0052, 0809STH0053, 0810STH0066, 0810STH0067, 0810STH0068, 0905STH0001, 0907STH0009, 0908STH0037, 0908STH0038, 0909STH0054, 0909STH0055, 0911STH0081, 0911STH0082, 1006STH0002, 1008STH0039, 1008STH0040, 1008STH0041, 1009STH0056, 1009STH0057, 1012STH0105, 1012STH0106, 1012STH0107, 1012STH0108, 1110STH0069, 1112STH0109, 1112STH0110, 1210STH0070, 1211STH0083, and 1211STH0084.",,"97 units","The lift might fail with the labeled 500-lb. load rating. ",10/30/2013,"10/30/2013",11/27/2013,"11/27/2013"
"Devices",66056,"Ongoing","Ergosafe Products LLC DBA Prism Medical Services USA","Maryland Heights","MO","US","Voluntary: Firm Initiated","E-Mail","Nationwide distribution.","Z-0371-2014","Class II","Medcare Products Max-500 Stand-N-Weigh, Total Support, patient stand, model #400007. The responsible firm name listed in the Operations Manual is Medcare Products, Burnsville, MN. Used for assisting patients/residents to a standing position.","Serial numbers 0106SWH0008, 0106SWH0009, 0106SWH0010, 0107SWH0031, 0107SWH0032, 0107SWH0033, 0107SWH0034, 0108SWH0044, 0108SWH0045, 0109SWH0065, 0109SWH0066, 0109SWH0067, 0109SWH0068, 0109SWH0069, 0109SWH0070, 0109SWH0071, 0111SWH0148, 0111SWH0149, 0111SWH0150, 0111SWH0151, 0112SWH0199, 0112SWH0200, 0112SWH0201, 0112SWH0202, 0112SWH0203, 0112SWH0204, 0206SWH0011, 0206SWH0012, 0209SWH0072, 0209SWH0073, 0209SWH0074, 0209SWH0075, 0209SWH0076, 0209SWH0077, 0209SWH0078, 0209SWH0079, 0211SWH0152, 0211SWH0153, 0211SWH0154, 0211SWH0155, 0211SWH0156, 0212SWH0210, 0212SWH0205, 0212SWH0206, 0212SWH0207, 0212SWH0208, 0212SWH0209, 0307SWH0035, 0308SWH0046, 0308SWH0047, 0309SWH0080, 0309SWH0081, 0309SWH0082, 0311SWH0157, 0311SWH0158, 0312SWH0211, 0312SWH0212, 0312SWH0213, 0312SWH0214, 0313SWH0234, 0313SWH0235, 0313SWH0236, 0408SWH0048, 0409SWH0083, 0409SWH0084, 0409SWH0085, 0409SWH0086, 0409SWH0087, 0409SWH0088, 0409SWH0089, 0409SWH0090, 0409SWH0091, 0409SWH0092, 0409SWH0093, 0409SWH0094, 0409SWH0095, 0409SWH0096, 0409SWH0097, 0409SWH0098, 0409SWH0099, 0411SWH0159, 0411SWH0161, 0412SWH0215, 0412SWH0216, 0507SWH0036, 0507SWH0037, 0507SWH0038, 0507SWH0039, 0508SWH0050, 0510SWH0118, 0510SWH0119, 0510SWH0120, 0510SWH0121, 0511SWH0162, 0511SWH0163, 0511SWH0164, 0512SWH0217, 0512SWH0218, 0512SWH0219, 0512SWH0220, 0512SWH0221, 0512SWH0222, 0613SWH0237, 0613SWH0238, 0613SWH0239, 0613SWH0240, 0613SWH0241, 0613SWH0242, 0613SWH0243, 0613SWH0244, 0613SWH0245, 0613SWH0246, 0613SWH0247, 0613SWH0248, 0613SWH0249, 0613SWH0250, 0708SWH0052, 0708SWH0053, 0709SWH0100, 0710SWH0122, 0710SWH0123, 0711SWH0165, 0711SWH0166, 0711SWH0167, 0711SWH0168, 0711SWH0169, 0711SWH0170, 0712SWH0223, 0712SWH0224, 0712SWH0225, 0805SWH0001, 0805SWH0002, 0805SWH0003, 0805SWH0004, 0806SWH0013, 0806SWH0014, 0806SWH0015, 0806SWH0016, 0808SWH0054, 0808SWH0055, 0808SWH0056, 0809SWH0101, 0810SWH0124, 0810SWH0125, 0810SWH0126, 0810SWH0127, 0812SWH0226, 0812SWH0227, 0812SWH0228, 0906SWH0017, 0907SWH0040, 0908SWH0057, 0908SWH0058, 0908SWH0059, 0908SWH0060, 0908SWH0",,"233 units","The lift might fail with the labeled 500-lb. load rating.",10/30/2013,"10/30/2013",11/27/2013,"11/27/2013"
"Devices",66057,"Ongoing","Tornier, Inc","Bloomington","MN","US","Voluntary: Firm Initiated","Letter",".Worldwide Distribution - USA including Puerto Rico and the states of AL, AZ, CA, CO,CT, FL, GA, IL, KY, MD, MA, MI, MN, NE, NJ, NC, OH, OR, PA and TX., and the countries of CANADA, MEXICO, HONG KONG, SOUTH AFRICA, ARGENTINA, COLOMBIA, ISRAEL, AUSTRALIA, BELGIUM, FINLAND,FRANCE, GERMANY, ITALY, NETHERLANDS, SLOVENIA, SPAIN, SWITZERLAND and UNITED KINGDOM","Z-2199-2013","Class II","AEQUALIS Reversed II or AEQUALIS Fracture Impactor. These products are contained within the Aequalis reversed II Instrument set tray no.YKAD83 and the Aequalis reversed fracture instrument set tray no.YKAD95. The items affected are MWD21, MWD023, MWD024 and MWD025. The impactor is an instrument used during shoulder arthroplasty; it is not implanted. The impactor is used to set the glenoid sphere, poly insert, spacer, and hemi adapter into place during surgery. The impactor is a two piece instrument which consists of a tip and a handle. The tip is made of plastic and metal that is pressed together for assembly. ","all lots",,"2,298 (1045 US, 1253 OUS)","Following the identification of the disassociation of an impactor tip during surgery, Tornier is initiating a voluntary recall of all lots of Aequalis Reversed II and Reversed Fracture impactors. Upon review of the event, Tornier determined that a redesign of the instrument was warranted. These products are contained within the Aequalis Revered II instrument set tray no YKAD83 and the Aequalis Revered Fracture instrument set tray no YKAD95.",8/13/2013,"08/13/2013",9/25/2013,"09/25/2013"
"Devices",66058,"Ongoing","Siemens Healthcare Diagnostics, Inc. ","West Sacramento","CA","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution - USA Nationwide in the states of: AK, SC, IA, MO GA, WI, TX, KS, CA, IL, CO, AZ, SD, IN, MD, FL, MN and the countries of:Japan, France, Algeria, Germany, Austria, Romania, Russian Federation, South Africa, Kazakhstan, Belgium, Great Britain, Turkey, Spain, Italy, Saudi Arabia, Qutar, Poland, Iraq, Unite Arab Emrites, Algeria, Oman, Greece, Portugal, and Ireland.","Z-2121-2013","Class I","Microscan Synergies Plus Negative Breakpoint Combo 7 Product Usage: MicroScan Synergies plus Panels & MicroScan Rapids plus (Negative) - For use in determining quantitative and/or qualitative antimicrobial agent susceptibility and/or identification for gram-negative bacteria.","Internal Number B1025-109, Catalog Number - 10444748 Lot code/expiration date: 2012-08-17, 2012-08-17; 2012-10-06, 2012-10-06; 2012-12-08, 2012-12-08; 2013-01-09, 2013-01-09; 2013-03-02, 2013-03-02; 2013-04-12, 2013-04-12; 2013-06-15, 2013-06-15; 2013-08-06, 2013-08-06; 2013-09-24, 2013-09-24; 2013-12-07, 2013-12-07; 2014-01-08, 2014-01-08; 2014-01-31, 2014-01-31; 2014-03-25, 2014-03-25; 2014-05-09, 2014-05-09; 2014-07-01, 2014-07-01. ",".","4319 boxes, 86, 380 panels","Confirmed increase in false susceptible and false intermediate misreads for Imipenem and/or meropenum on Synergies plus Negative and rap ID/S plus Negative panels read on Walk Away System.",8/21/2013,"08/21/2013",9/18/2013,"09/18/2013"
"Devices",66058,"Ongoing","Siemens Healthcare Diagnostics, Inc. ","West Sacramento","CA","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution - USA Nationwide in the states of: AK, SC, IA, MO GA, WI, TX, KS, CA, IL, CO, AZ, SD, IN, MD, FL, MN and the countries of:Japan, France, Algeria, Germany, Austria, Romania, Russian Federation, South Africa, Kazakhstan, Belgium, Great Britain, Turkey, Spain, Italy, Saudi Arabia, Qutar, Poland, Iraq, Unite Arab Emrites, Algeria, Oman, Greece, Portugal, and Ireland.","Z-2122-2013","Class I","Microscan Synergies Plus Negative Urine Combo 2 Product Usage: MicroScan Synergies plus Panels & MicroScan Rapids plus (Negative) - For use in determining quantitative and/or qualitative antimicrobial agent susceptibility and/or identification for gram-negative bacteria.","Internal Number - B1025-112 Catalog Number - 10444749 Lot code/expiration date: 2012-07-12, 2012-07-12; 2012-10-03, 2012-10-03; 2013-06-08, 2013-06-08; 2013-12-17, 2013-12-17; 2014-04-22, 2014-04-22; 2014-06-11, 2014-06-11; ",".","1,324 boxes, 26,480 panels","Confirmed increase in false susceptible and false intermediate misreads for Imipenem and/or meropenum on Synergies plus Negative and rap ID/S plus Negative panels read on Walk Away System.",8/21/2013,"08/21/2013",9/18/2013,"09/18/2013"
"Devices",66058,"Ongoing","Siemens Healthcare Diagnostics, Inc. ","West Sacramento","CA","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution - USA Nationwide in the states of: AK, SC, IA, MO GA, WI, TX, KS, CA, IL, CO, AZ, SD, IN, MD, FL, MN and the countries of:Japan, France, Algeria, Germany, Austria, Romania, Russian Federation, South Africa, Kazakhstan, Belgium, Great Britain, Turkey, Spain, Italy, Saudi Arabia, Qutar, Poland, Iraq, Unite Arab Emrites, Algeria, Oman, Greece, Portugal, and Ireland.","Z-2119-2013","Class I","Microscan Synergies Plus Negative Urine Combo 1 Product Usage: MicroScan Synergies plus Panels & MicroScan Rapids plus (Negative) - For use in determining quantitative and/or qualitative antimicrobial agent susceptibility and/or identification for gram-negative bacteria. "," Internal Number - B1025-106; Catalog Number -10444745; Lot code/expiration date: 2012-12-05, 2012-12-05; 2013-01-16, 2013-01-16; 2013-02-28, 2013-02-28; 2014-01-11, 2014-01-11; 2014-02-11, 2014-02-11; 2014-05-21, 2014-05-21. ",".","1209 boxes, 24, 180 panels","Confirmed increase in false susceptible and false intermediate misreads for Imipenem and/or meropenum on Synergies plus Negative and rap ID/S plus Negative panels read on Walk Away System.",8/21/2013,"08/21/2013",9/18/2013,"09/18/2013"
"Devices",66058,"Ongoing","Siemens Healthcare Diagnostics, Inc. ","West Sacramento","CA","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution - USA Nationwide in the states of: AK, SC, IA, MO GA, WI, TX, KS, CA, IL, CO, AZ, SD, IN, MD, FL, MN and the countries of:Japan, France, Algeria, Germany, Austria, Romania, Russian Federation, South Africa, Kazakhstan, Belgium, Great Britain, Turkey, Spain, Italy, Saudi Arabia, Qutar, Poland, Iraq, Unite Arab Emrites, Algeria, Oman, Greece, Portugal, and Ireland.","Z-2128-2013","Class I","Microscan rapID/S panels NC3.12 Sold in Japan only. Product Usage: MicroScan Synergies plus Panels & MicroScan Rapids plus (Negative) - For use in determining quantitative and/or qualitative antimicrobial agent susceptibility and/or identification for gram-negative bacteria.","Internal Number - J1025-312; Catalog Number - 10444793 ",".","57,600 panels in total ","Confirmed increase in false susceptible and false intermediate misreads for Imipenem and/or meropenum on Synergies plus Negative and rap ID/S plus Negative panels read on Walk Away System.",8/21/2013,"08/21/2013",9/18/2013,"09/18/2013"
"Devices",66058,"Ongoing","Siemens Healthcare Diagnostics, Inc. ","West Sacramento","CA","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution - USA Nationwide in the states of: AK, SC, IA, MO GA, WI, TX, KS, CA, IL, CO, AZ, SD, IN, MD, FL, MN and the countries of:Japan, France, Algeria, Germany, Austria, Romania, Russian Federation, South Africa, Kazakhstan, Belgium, Great Britain, Turkey, Spain, Italy, Saudi Arabia, Qutar, Poland, Iraq, Unite Arab Emrites, Algeria, Oman, Greece, Portugal, and Ireland.","Z-2129-2013","Class I","Microscan rapID/S panels NC3.33 Sold in Japan only. Product Usage: MicroScan Synergies plus Panels & MicroScan Rapids plus (Negative) - For use in determining quantitative and/or qualitative antimicrobial agent susceptibility and/or identification for gram-negative bacteria.","Internal Number - J1025-333; Catalog Number - 10444794 ",".","57,600 panels in total ","Confirmed increase in false susceptible and false intermediate misreads for Imipenem and/or meropenum on Synergies plus Negative and rap ID/S plus Negative panels read on Walk Away System.",8/21/2013,"08/21/2013",9/18/2013,"09/18/2013"
"Devices",66058,"Ongoing","Siemens Healthcare Diagnostics, Inc. ","West Sacramento","CA","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution - USA Nationwide in the states of: AK, SC, IA, MO GA, WI, TX, KS, CA, IL, CO, AZ, SD, IN, MD, FL, MN and the countries of:Japan, France, Algeria, Germany, Austria, Romania, Russian Federation, South Africa, Kazakhstan, Belgium, Great Britain, Turkey, Spain, Italy, Saudi Arabia, Qutar, Poland, Iraq, Unite Arab Emrites, Algeria, Oman, Greece, Portugal, and Ireland.","Z-2126-2013","Class I","Microscan plus Negative Breakpoint Combo 4 Sold outside of US only. Product Usage: MicroScan Synergies plus Panels & MicroScan Rapids plus (Negative) - For use in determining quantitative and/or qualitative antimicrobial agent susceptibility and/or identification for gram-negative bacteria.","Internal Number - B1016-203; Catalog Number - 10460272 ",".","57,600 panels in total ","Confirmed increase in false susceptible and false intermediate misreads for Imipenem and/or meropenum on Synergies plus Negative and rap ID/S plus Negative panels read on Walk Away System.",8/21/2013,"08/21/2013",9/18/2013,"09/18/2013"
"Devices",66058,"Ongoing","Siemens Healthcare Diagnostics, Inc. ","West Sacramento","CA","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution - USA Nationwide in the states of: AK, SC, IA, MO GA, WI, TX, KS, CA, IL, CO, AZ, SD, IN, MD, FL, MN and the countries of:Japan, France, Algeria, Germany, Austria, Romania, Russian Federation, South Africa, Kazakhstan, Belgium, Great Britain, Turkey, Spain, Italy, Saudi Arabia, Qutar, Poland, Iraq, Unite Arab Emrites, Algeria, Oman, Greece, Portugal, and Ireland.","Z-2124-2013","Class I","Microscan plus Negative Combo 3 Sold outside of US only. Product Usage: MicroScan Synergies plus Panels & MicroScan Rapids plus (Negative) - For use in determining quantitative and/or qualitative antimicrobial agent susceptibility and/or identification for gram-negative bacteria.","Internal Number - B1016-201; Catalog Number - 10444600 ",".","57,600 panels in total ","Confirmed increase in false susceptible and false intermediate misreads for Imipenem and/or meropenum on Synergies plus Negative and rap ID/S plus Negative panels read on Walk Away System.",8/21/2013,"08/21/2013",9/18/2013,"09/18/2013"
"Devices",66058,"Ongoing","Siemens Healthcare Diagnostics, Inc. ","West Sacramento","CA","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution - USA Nationwide in the states of: AK, SC, IA, MO GA, WI, TX, KS, CA, IL, CO, AZ, SD, IN, MD, FL, MN and the countries of:Japan, France, Algeria, Germany, Austria, Romania, Russian Federation, South Africa, Kazakhstan, Belgium, Great Britain, Turkey, Spain, Italy, Saudi Arabia, Qutar, Poland, Iraq, Unite Arab Emrites, Algeria, Oman, Greece, Portugal, and Ireland.","Z-2120-2013","Class I","Microscan Synergies Plus Negative Combo 2 Product Usage: MicroScan Synergies plus Panels & MicroScan Rapids plus (Negative) - For use in determining quantitative and/or qualitative antimicrobial agent susceptibility and/or identification for gram-negative bacteria.","Internal Number - B1025-108; Catalog Number - 10444747; Lot code/expiration date: 2012-06-27, 2012-06-27; 2012-08-10, 2012-08-10; 2012-10-12, 2012-10-12; 2012-11-30, 2012-11-30; 2013-01-06, 2013-01-06; 2013-02-01, 2013-02-01; 2013-03-27, 2013-03-27; 2013-10-02, 2013-10-02; 2013-11-21, 2013-11-21; 2014-01-24, 2014-01-24; 2014-03-28, 2014-03-28; 2014-05-03, 2014-05-03. ",".","2158 boxes, 43,160 panels","Confirmed increase in false susceptible and false intermediate misreads for Imipenem and/or meropenum on Synergies plus Negative and rap ID/S plus Negative panels read on Walk Away System.",8/21/2013,"08/21/2013",9/18/2013,"09/18/2013"
"Devices",66058,"Ongoing","Siemens Healthcare Diagnostics, Inc. ","West Sacramento","CA","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution - USA Nationwide in the states of: AK, SC, IA, MO GA, WI, TX, KS, CA, IL, CO, AZ, SD, IN, MD, FL, MN and the countries of:Japan, France, Algeria, Germany, Austria, Romania, Russian Federation, South Africa, Kazakhstan, Belgium, Great Britain, Turkey, Spain, Italy, Saudi Arabia, Qutar, Poland, Iraq, Unite Arab Emrites, Algeria, Oman, Greece, Portugal, and Ireland.","Z-2127-2013","Class I","MicroscanrapID/S panels NC3.11 Sold in Japan only. Product Usage: MicroScan Synergies plus Panels & MicroScan Rapids plus (Negative) - For use in determining quantitative and/or qualitative antimicrobial agent susceptibility and/or identification for gram-negative bacteria.","Internal Number - J1025-311; Catalog Number - 10444792 ",".","57,600 panels in total ","Confirmed increase in false susceptible and false intermediate misreads for Imipenem and/or meropenum on Synergies plus Negative and rap ID/S plus Negative panels read on Walk Away System.",8/21/2013,"08/21/2013",9/18/2013,"09/18/2013"
"Devices",66058,"Ongoing","Siemens Healthcare Diagnostics, Inc. ","West Sacramento","CA","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution - USA Nationwide in the states of: AK, SC, IA, MO GA, WI, TX, KS, CA, IL, CO, AZ, SD, IN, MD, FL, MN and the countries of:Japan, France, Algeria, Germany, Austria, Romania, Russian Federation, South Africa, Kazakhstan, Belgium, Great Britain, Turkey, Spain, Italy, Saudi Arabia, Qutar, Poland, Iraq, Unite Arab Emrites, Algeria, Oman, Greece, Portugal, and Ireland.","Z-2125-2013","Class I","Microscan plus Negative Urine Combo 4 Sold outside of US only. Product Usage: MicroScan Synergies plus Panels & MicroScan Rapids plus (Negative) - For use in determining quantitative and/or qualitative antimicrobial agent susceptibility and/or identification for gram-negative bacteria.","Internal Number - B1016-202; Catalog Number - 10444601 ",".","57,600 panels in total ","Confirmed increase in false susceptible and false intermediate misreads for Imipenem and/or meropenum on Synergies plus Negative and rap ID/S plus Negative panels read on Walk Away System.",8/21/2013,"08/21/2013",9/18/2013,"09/18/2013"
"Devices",66058,"Ongoing","Siemens Healthcare Diagnostics, Inc. ","West Sacramento","CA","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution - USA Nationwide in the states of: AK, SC, IA, MO GA, WI, TX, KS, CA, IL, CO, AZ, SD, IN, MD, FL, MN and the countries of:Japan, France, Algeria, Germany, Austria, Romania, Russian Federation, South Africa, Kazakhstan, Belgium, Great Britain, Turkey, Spain, Italy, Saudi Arabia, Qutar, Poland, Iraq, Unite Arab Emrites, Algeria, Oman, Greece, Portugal, and Ireland.","Z-2123-2013","Class I","Microscan Synergies Plus Negative Urine Combo 5 Product Usage: MicroScan Synergies plus Panels & MicroScan Rapids plus (Negative) - For use in determining quantitative and/or qualitative antimicrobial agent susceptibility and/or identification for gram-negative bacteria.","Internal Number - B1025-115; Catalog Number - 10483101 Lot code/expiration date: 2012-09-22, 2012-09-22; 2013-01-20, 2013-01-20; 2013-05-07, 2013-05-07; 2013-11-01, 2013-11-01; 2014-03-05, 2014-03-05. ",".","522 boxes, 10, 440 panels","Confirmed increase in false susceptible and false intermediate misreads for Imipenem and/or meropenum on Synergies plus Negative and rap ID/S plus Negative panels read on Walk Away System.",8/21/2013,"08/21/2013",9/18/2013,"09/18/2013"
"Devices",66059,"Ongoing","Toshiba American Medical Systems Inc","Tustin","CA","US","Voluntary: Firm Initiated","Letter","Nationwide Distribution including and US Territory Puerto Rico","Z-0119-2014","Class II","Xario Diagnostic Ultrasound System SSA-660A Used for routine diagnostic imaging ","Lot Numbers not utilized. Serial Numbers: LGA0792628 LGA0792564 LGA0792565 LGA0792531 LGA0792540 LGA0792541 LGA0792617 LGA0792554 LGA0792626 LGA0792627 LGA0792552 LGA0792616 LGA0792563 LGA0792553 LGA0792615 LGA0792551 LGA0792613 ",,"477 (1352 total)","The firm initiated this recall of certain Toshiba Diagnostic Ultrasound Systems because it has been found that under certain conditions, the temperature of the transducer head may increase in 2D+PW mode or 2D+CDI (POWER, ADF) +PW mode. When the system is used under both conditions listed below, the temperature of the transducer head connected to the system may increase in temperature and possibly cause the patient to be burned during the procedure:1. The system is set to 2D+PW mode or 2D+CDI (POWER, ADF) +PW mode, and 2) ''IQBalance BD'' or ''IQ Balance'' BCD'' is displayed on the touch panel as a result of scale setting for PW mode.",8/5/2013,"08/05/2013",11/6/2013,"11/06/2013"
"Devices",66059,"Ongoing","Toshiba American Medical Systems Inc","Tustin","CA","US","Voluntary: Firm Initiated","Letter","Nationwide Distribution including and US Territory Puerto Rico","Z-0121-2014","Class II","Aplio MX Diagnostic Ultrasound System SSA-780A Used for routine diagnostic imaging ","Lot Numbers not utilized. Serial Numbers: 99D0833447 99E0873714 99G0995029 99D0823343 99F0924404 99G09Y5216 99E0863552 99E0863553 99G0964771 99C0792920 99F0893870 99B06Z2073 99C07X2964 99C0792918 99B06Z2063 99C0792919 99G0964712 99G0964713 99G0974899 99F0944563 99D0823349 99G0995131 99G0995132 99G0995133 99G0995134 99G09Y5224 99C0792914 99D0813229 99D0813230 99D0813231 99E0873711 99E0873716 99E0873717 99B06Z2072 99B0752508 99B0752509 99B0752510 99B0752511 99C0792915 99C0792937 99F0893967 99F08Y4079 99F08Y4085 99F08Y4086 99F0924389 99F0924395 99F0924405 99B06Z2107 99G1045683 99C07Y3068 99C07Y3069 99B0782760 99C07Y3047 99B0722268 99B0722269 99B0722270 99B0722271 99B0722272 99B0732349 99B0732350 99B0732351 99B0732352 99B0732353 99B0732354 99E0863691 99E0863692 99G0995139 99B0722208 99B0722250 99F0934520 99C0782863 99B06Z2061 99G0995071 99G09Y5260 99G09Y5261 99D0813225 99D0813226 99E0863586 99E0863587 99C0782860 99G0964777 99B0752531 99D07Z3138 99D0813224 99B0752532 99D07Z3139 99B06Z2088 99B0722251 99C07X2965 99F0914260 99F0914261 99F0914269 99G09Z5369 99G09Y5256 99F08Y4078 99D0833438 99G09Z5367 99F0893846 99E0873713 99B06Z2071 99C0782864 99C07Y3061 99D0833437 99G0974883 99G0974884 99F0893855 99F0893854 99B0782767 99B0782786 99F0914266 99G1015473 99G09Z5370 99G09Z5374 99G09Z5375 99G1015474 99B06Z2109 99B06Z2068 99B06Z2060 99C0792930 99D0823363 99D0833441 99D0823364 99D0823365 99D0833440 99G09Y5264 99B0722206 99B0722207 99B0722204 99B0752524 99B0752525 99F0914265 99F0914289 99E0873720 99G09Y5257 99F0893866 99F0893969 99D0823351 99B0732355 99B0742413 99B0742414 99G0995135 99D0823342 99E0863572 99D0833450 99E0863549 99E0863550 99E0873712 99E0863570 99E0863571 99B06Z2055 99D0833451 99B0742415 99B0742416 99B0742417 99G09Y5223 99F0914263 99B0722203 99B0782788 99C0782866 99B06Z2062 99F0934528 99B0782766 99B0722201 99F0893961 99F0934532 99G09Z5379 99G1015468 99F0924394 99G1015472 99G09Y5262 99G09Y5263 99B0722252 99G0974886 99F0893868 99F0893869 99G0964772 99F0944536 99F0893851 99F0934527 99G09Y5258 99B0752548 99G1045682 9",,"14 Lots","Diluent containing phenol failed an apperance test on stability. The Diluent is included in the JHS licensed venomil kits that were distributed. ",7/3/2013,"07/03/2013",11/6/2013,"11/06/2013"
"Devices",66059,"Ongoing","Toshiba American Medical Systems Inc","Tustin","CA","US","Voluntary: Firm Initiated","Letter","Nationwide Distribution including and US Territory Puerto Rico","Z-0120-2014","Class II","Xario XG Diagnostic Ultrasound System SSA-680A Used for routine diagnostic imaging ","Lot Numbers not utilized. Serial Numbers: 99A07Y2151 99E0993437 99K1285044 99F1033857 99F1033858 99F1033859 99K11Z4906 99K11Z4907 99J1114445 99G1094194 99H10X4240 99E0973301 99G1074050 99G1074051 99G1074052 99E0973302 99J1114443 99G1084118 99D0892684 99K1184804 99D08Y2744 99K1285039 99K11Z4917 99E0963141 99E0963157 99E0963158 99E0963168 99D0892680 99D0892687 99D08Z2840 99D0953122 99E0973308 99E09X3463 99F09Z3684 99D08Z2829 99E0993408 99K1285041 99D0892692 99A07Y2109 99E0993414 99E0993415 99K1214940 99E0983369 99D0892688 99D0892689 99D0892691 99D0892693 99C0872552 99C0872568 99A07Y2097 99A07Y2098 99B07Z2248 99E0993436 99E0993445 99K1234985 99D0953125 99K1184805 99K1285046 99K12X5050 99K12X5051 99K12X5052 99K12X5053 99D0912881 99D08Y2762 99D0922958 99D0922959 99D0922960 99H10X4236 99K12Y5055 99K11Z4928 99F09Z3691 99C0872564 99F1043913 99K1244991 99A07Y2086 99E0973304 99G1053958 99J1134603 99E0983371 99A07Y2100 99B07Z2242 99B07Z2251 99F09Z3664 99D0943018 99E09X3467 99D08Y2759 99D08Y2760 99C0872551 99A07Y2089 99D0922957 99H10X4242 99D0953102 99A07Y2092 99A07Y2106 99A07Y2157 99B07Z2233 99B07Z2258 99C0882610 99C0882611 99D0943045 99D0943047 99E0983370 99F1013749 99F1033860 99F1043912 99G1053954 99G1053956 99K11Z4904 99K1285040 99A07Y2094 99H10X4237 99D08Z2826 99G1053962 99F09Z3663 99K11Z4905 99E09X3450 99C0872566 99A07Y2104 99F1013734 99B07Z2260 99A07Y2083 99D0953124 99D0892681 99J1114444 99E0993446 99J1124539 99J1134600 99A07Y2108 99K11Z4929 99A07Y2085 99F1043911 99E09X3462 99C0882619 99D08Y2747 99C0882607 99C0882608 99F1013743 99A07Y2091 99E0993447 99E0993448 99E0973310 99E0983362 99A07Y2159 99A07Y2158 99B07Z2252 99E09X3504 99J1144668 99J1124540 99J1134601 99G1053951 99H10X4239 99I10Z4387 99I10Z4388 99D0922954 99K1164753 99K1265026 99B07Z2249 99H10X4235 99K1194857 99K11X4876 99D0912880 99F1013735 99K11X4864 99G1084120 99G1084121 99G1094181 99G1094182 99G1094183 99K11Z4922 99G1053960 99F1013737 99E0983372 99E0983373 99F09Z3668 99G1064005 99D0943049 99K1285038 99D0892690 99E09X3461 99D0943048 99D0912884 99E0993416 9",,"477 (1352 total)","The firm initiated this recall of certain Toshiba Diagnostic Ultrasound Systems because it has been found that under certain conditions, the temperature of the transducer head may increase in 2D+PW mode or 2D+CDI (POWER, ADF) +PW mode. When the system is used under both conditions listed below, the temperature of the transducer head connected to the system may increase in temperature and possibly cause the patient to be burned during the procedure:1. The system is set to 2D+PW mode or 2D+CDI (POWER, ADF) +PW mode, and 2) ''IQBalance BD'' or ''IQ Balance'' BCD'' is displayed on the touch panel as a result of scale setting for PW mode.",8/5/2013,"08/05/2013",11/6/2013,"11/06/2013"
"Devices",66059,"Ongoing","Toshiba American Medical Systems Inc","Tustin","CA","US","Voluntary: Firm Initiated","Letter","Nationwide Distribution including and US Territory Puerto Rico","Z-0122-2014","Class II","Aplio XG Diagnostic Ultrasound System SSA-790A Used for routine diagnostic imaging ","Lot Numbers not utilized. Serial Numbers: 99D0833447 99E0873714 99G0995029 99D0823343 99F0924404 99G09Y5216 99E0863552 99E0863553 99G0964771 99C0792920 99F0893870 99B06Z2073 99C07X2964 99C0792918 99B06Z2063 99C0792919 99G0964712 99G0964713 99G0974899 99F0944563 99D0823349 99G0995131 99G0995132 99G0995133 99G0995134 99G09Y5224 99C0792914 99D0813229 99D0813230 99D0813231 99E0873711 99E0873716 99E0873717 99B06Z2072 99B0752508 99B0752509 99B0752510 99B0752511 99C0792915 99C0792937 99F0893967 99F08Y4079 99F08Y4085 99F08Y4086 99F0924389 99F0924395 99F0924405 99B06Z2107 99G1045683 99C07Y3068 99C07Y3069 99B0782760 99C07Y3047 99B0722268 99B0722269 99B0722270 99B0722271 99B0722272 99B0732349 99B0732350 99B0732351 99B0732352 99B0732353 99B0732354 99E0863691 99E0863692 99G0995139 99B0722208 99B0722250 99F0934520 99C0782863 99B06Z2061 99G0995071 99G09Y5260 99G09Y5261 99D0813225 99D0813226 99E0863586 99E0863587 99C0782860 99G0964777 99B0752531 99D07Z3138 99D0813224 99B0752532 99D07Z3139 99B06Z2088 99B0722251 99C07X2965 99F0914260 99F0914261 99F0914269 99G09Z5369 99G09Y5256 99F08Y4078 99D0833438 99G09Z5367 99F0893846 99E0873713 99B06Z2071 99C0782864 99C07Y3061 99D0833437 99G0974883 99G0974884 99F0893855 99F0893854 99B0782767 99B0782786 99F0914266 99G1015473 99G09Z5370 99G09Z5374 99G09Z5375 99G1015474 99B06Z2109 99B06Z2068 99B06Z2060 99C0792930 99D0823363 99D0833441 99D0823364 99D0823365 99D0833440 99G09Y5264 99B0722206 99B0722207 99B0722204 99B0752524 99B0752525 99F0914265 99F0914289 99E0873720 99G09Y5257 99F0893866 99F0893969 99D0823351 99B0732355 99B0742413 99B0742414 99G0995135 99D0823342 99E0863572 99D0833450 99E0863549 99E0863550 99E0873712 99E0863570 99E0863571 99B06Z2055 99D0833451 99B0742415 99B0742416 99B0742417 99G09Y5223 99F0914263 99B0722203 99B0782788 99C0782866 99B06Z2062 99F0934528 99B0782766 99B0722201 99F0893961 99F0934532 99G09Z5379 99G1015468 99F0924394 99G1015472 99G09Y5262 99G09Y5263 99B0722252 99G0974886 99F0893868 99F0893869 99G0964772 99F0944536 99F0893851 99F0934527 99G09Y5258 99B0752548 99G1045682 9",,"430 (1352 total)","The firm initiated this recall of certain Toshiba Diagnostic Ultrasound Systems because it has been found that under certain conditions, the temperature of the transducer head may increase in 2D+PW mode or 2D+CDI (POWER, ADF) +PW mode. When the system is used under both conditions listed below, the temperature of the transducer head connected to the system may increase in temperature and possibly cause the patient to be burned during the procedure:1. The system is set to 2D+PW mode or 2D+CDI (POWER, ADF) +PW mode, and 2) ''IQBalance BD'' or ''IQ Balance'' BCD'' is displayed on the touch panel as a result of scale setting for PW mode.",8/5/2013,"08/05/2013",11/6/2013,"11/06/2013"
"Devices",66059,"Ongoing","Toshiba American Medical Systems Inc","Tustin","CA","US","Voluntary: Firm Initiated","Letter","Nationwide Distribution including and US Territory Puerto Rico","Z-0121-2014","Class II","Aplio MX Diagnostic Ultrasound System SSA-780A Used for routine diagnostic imaging ","Lot Numbers not utilized. Serial Numbers: A1G1194387 A1E10Z3293 A1E10Z3294 99A09Y2120 99B09Z2178 99B09Z2179 A1F1143915 A1G1194385 A1G1194394 A1G1194395 A1G1194396 A1E10Z3339 A1E10Z3340 A1E10Z3341 A1G11Z4565 99B09Z2174 A1G1174188 A1G1194355 A1G1194356 A1G1184257 A1G1184258 A1G1194392 A1G1194406 99B1022343 A1F1113439 A1F1133733 A1F1133846 A1C1072756 A1C1072763 A1C1082867 99A09X2090 99A09X2092 A1C1093010 A1G1214637 A1G11Z4566 A1E10Z3295 A1E10Z3308 A1E10Z3312 A1G1194397 A1E10Z3311 A1F1123626 A1F1123633 A1C1082816 A1C1082830 A1C1082837 A1C1082838 A1C1082842 A1C1082843 A1C1082847 A1G1194373 A1F1123624 A1G1194393 A1F1133840 99B1032438 A1F1113440 A1F1113443 A1F1113444 A1F1133863 A1F1123693 A1F1133760 A1F1133772 A1F1133773 A1C1092961 A1C1092970 A1B1062657 A1E10Z3296 A1G11Z4575 A1F1133740 A1F1133780 A1C1093018 A1G1194384 A1F1133776 A1G1184302 A1G1184303 A1G1194364 A1G1194371 A1G1194372 A1C1082874 A1B1062687 A1C1082868 A1C1082873 A1C1082851 A1C1082862 A1C1082856 A1C1082884 A1G1214636 A1C1082861 A1C1082879 A1C1082880 A1C1082885 A1G1184256 A1G1194401 A1E10Z3359 A1E10Z3360 A1E10Z3361 A1E10Z3369 A1E10Z3370 A1E10Z3371 A1F1123625 A1F1113455 A1A1042483 A1B1052583 A1C1072774 A1C1072782 99B1022344 99B1022347 A1A1042474 A1A1042477 A1A1042480 A1A1042496 99B1032444 A1C1092929 99A09X2087 99A09X2091 99A09Y2114 A1G11Z4568 A1F1133737 A1G1194383 99B1032416 99B09Z2173 99B09Z2182 A1G1184276 A1E10Z3306 A1E10Z3307 A1F1123614 A1B1062646 A1B1062651 A1G1194379 A1E10Z3326 99B09Z2180 99B09Z2181 A1G11Z4567 A1F1123665 99B09Z2171 A1B1062664 A1B1062665 99B1032437 A1F1143918 A1E10Z3356 A1G1194398 99A09Y2116 99B1012242 A1F1123679 A1G1194377 A1C1092920 99B1012227 A1F1133875 99A09X2094 A1A1042491 A1A1042501 A1B1052571 A1F1113466 99B1022345 99B1022346 A1B1062656 A1B1062691 A1B1062696 A1F1133862 A1A1042513 A1B1052569 A1G1184296 99B1012243 A1F1143887 A1B1062634 A1F1133763 A1F1123692 A1E10Z3357 99B1022351 A1G1184289 A1G1184295 A1G1194403 A1F1133762 99B1032447 99A09X2095 99A09Y2113 A1F1143927 A1F1113442 A1F1133764 A1C1072754 A1C1072755 A1C1082823 A1C1072764 A",,"427 units (1352 total)","The firm initiated this recall of certain Toshiba Diagnostic Ultrasound Systems because it has been found that under certain conditions, the temperature of the transducer head may increase in 2D+PW mode or 2D+CDI (POWER, ADF) +PW mode. When the system is used under both conditions listed below, the temperature of the transducer head connected to the system may increase in temperature and possibly cause the patient to be burned during the procedure:1. The system is set to 2D+PW mode or 2D+CDI (POWER, ADF) +PW mode, and 2) ''IQBalance BD'' or ''IQ Balance'' BCD'' is displayed on the touch panel as a result of scale setting for PW mode.",8/5/2013,"08/05/2013",11/6/2013,"11/06/2013"
"Devices",66059,"Ongoing","Toshiba American Medical Systems Inc","Tustin","CA","US","Voluntary: Firm Initiated","Letter","Nationwide Distribution including and US Territory Puerto Rico","Z-0119-2014","Class II","Xario Diagnostic Ultrasound System SSA-660A Used for routine diagnostic imaging ","Lot Numbers not utilized. Serial Numbers: LGA0792628 LGA0792564 LGA0792565 LGA0792531 LGA0792540 LGA0792541 LGA0792617 LGA0792554 LGA0792626 LGA0792627 LGA0792552 LGA0792616 LGA0792563 LGA0792553 LGA0792615 LGA0792551 LGA0792613 ",,"17 (1352 Total)","The firm initiated this recall of certain Toshiba Diagnostic Ultrasound Systems because it has been found that under certain conditions, the temperature of the transducer head may increase in 2D+PW mode or 2D+CDI (POWER, ADF) +PW mode. When the system is used under both conditions listed below, the temperature of the transducer head connected to the system may increase in temperature and possibly cause the patient to be burned during the procedure:1. The system is set to 2D+PW mode or 2D+CDI (POWER, ADF) +PW mode, and 2) ''IQBalance BD'' or ''IQ Balance'' BCD'' is displayed on the touch panel as a result of scale setting for PW mode.",8/5/2013,"08/05/2013",11/6/2013,"11/06/2013"
"Devices",66060,"Ongoing","Churchill Medical Systems, Inc.","Dover","NH","US","Voluntary: Firm Initiated","E-Mail","Nationwide Distribution (US), including the states of NY, MN, NJ, PA, FL, MD, and VA.","Z-2252-2013","Class II","Central Dressing Change Kit; AMS-8464CP- 6. Vygon Central Dressing Change Kit contains: 1 Pair Nitrile Gloves W/Wallet, Powderfree 1 Face Mask 1 Polylined Drape, 13'' X 18'' 1 ChloraPrep***, 3ml Applicator W/Insert 1 Pkg. Alcohol Swabsticks (3/Pkg.) 1 14'' Extension Set W/Bionector*** 2 Dressing Sponges, 2'' X 2'' 1 Foam Strip, 8/5cm X 1cm 1 3M*** Tegaderm *** IV Dressing W/CHG, 2 1/2'' X 4 1/2'' *** Vygon MFG Dover, NH 03820***''","Lot Numbers: 1303022, 1304065",,"3040","Microbore tubing disconnecting from male luers on the extension sets. ",8/12/2013,"08/12/2013",9/25/2013,"09/25/2013"
"Devices",66060,"Ongoing","Churchill Medical Systems, Inc.","Dover","NH","US","Voluntary: Firm Initiated","E-Mail","Nationwide Distribution (US), including the states of NY, MN, NJ, PA, FL, MD, and VA.","Z-2251-2013","Class II","Vygon 14 Microbore Extension Set with Bionector, CMS-814-1. The CMS-814-1 is a 14 inch extension set used to administer IV fluids.","1203117, 1206030, 1212111, 1304133, 130516",,"13100","Microbore tubing disconnecting from male luers on the extension sets. ",8/12/2013,"08/12/2013",9/25/2013,"09/25/2013"
"Biologics",66061,"Completed","Jubilant HollisterStier, LLC","Spokane","WA","US","Voluntary: Firm Initiated","Letter","Canada; Multiple U.S. States and Multiple Countries","B-2474-13","Class II","White Faced Hornet Venom Protein","A1200032; A1200100; A1300043; M26862H; A1200019; A1200080; A1200123; A1300031; D26862F; A1300025; D26862E; A1200079; M26862I",,"13 Lots","Diluent containing phenol failed an apperance test on stability. The Diluent is included in the JHS licensed venomil kits that were distributed. ",7/3/2013,"07/03/2013",11/6/2013,"11/06/2013"
"Biologics",66061,"Completed","Jubilant HollisterStier, LLC","Spokane","WA","US","Voluntary: Firm Initiated","Letter","Canada; Multiple U.S. States and Multiple Countries","B-2473-13","Class II","Honey Bee Venom","A1200016; A1200053; A1300028; A1300051; M26969B; M26969F; M32153B; A1200030; A1200090; A1300033; D26969A; D26969E; D32153A; A1200054; A1200121; A1200006; A1300059; ",,"17 Lots","Diluent containing phenol failed an apperance test on stability. The Diluent is included in the JHS licensed venomil kits that were distributed. ",7/3/2013,"07/03/2013",11/6/2013,"11/06/2013"
"Biologics",66061,"Completed","Jubilant HollisterStier, LLC","Spokane","WA","US","Voluntary: Firm Initiated","Letter","Canada; Multiple U.S. States and Multiple Countries","B-2477-13","Class II","Yellow Jacket Venom Protein","A1300024; D26968D; D29155C; A1200045; A1200076; M29155A; A1200017; A1200077; D26968E; D29155D; A1300026; M26968F; M29155B",,"13 Lots","Diluent containing phenol failed an apperance test on stability. The Diluent is included in the JHS licensed venomil kits that were distributed. ",7/3/2013,"07/03/2013",11/6/2013,"11/06/2013"
"Biologics",66061,"Completed","Jubilant HollisterStier, LLC","Spokane","WA","US","Voluntary: Firm Initiated","Letter","Canada; Multiple U.S. States and Multiple Countries","B-2477-13","Class II","Yellow Jacket Venom Protein","A1300024; D26968D; D29155C; A1200045; A1200076; M29155A; A1200017; A1200077; D26968E; D29155D; A1300026; M26968F; M29155B",,"13 Lots","Diluent containing phenol failed an apperance test on stability. The Diluent is included in the JHS licensed venomil kits that were distributed. ",7/3/2013,"07/03/2013",11/6/2013,"11/06/2013"
"Biologics",66061,"Completed","Jubilant HollisterStier, LLC","Spokane","WA","US","Voluntary: Firm Initiated","Letter","Canada; Multiple U.S. States and Multiple Countries","B-2478-13","Class II","Mixed Vespid Venom Protein","A1200020; A1200068; A1300030; A1300054; M27840A; M30396B; A1200075; A1300027; M27840B; M30396A; M31296A",,"11 lots","Diluent containing phenol failed an apperance test on stability. The Diluent is included in the JHS licensed venomil kits that were distributed. ",7/3/2013,"07/03/2013",11/6/2013,"11/06/2013"
"Biologics",66061,"Completed","Jubilant HollisterStier, LLC","Spokane","WA","US","Voluntary: Firm Initiated","Letter","Canada; Multiple U.S. States and Multiple Countries","B-2475-13","Class II","Yellow Hornet Venom Protein","A1200035; A1200099; A1300032; M26865I; A1200018; A1200125; A1300034; D26865H; A1200007; D26865G; A1200005; A1200078; A1200089; M26865F",,"14 Lots","Diluent containing phenol failed an apperance test on stability. The Diluent is included in the JHS licensed venomil kits that were distributed. ",7/3/2013,"07/03/2013",11/6/2013,"11/06/2013"
"Biologics",66061,"Completed","Jubilant HollisterStier, LLC","Spokane","WA","US","Voluntary: Firm Initiated","Letter","Canada; Multiple U.S. States and Multiple Countries","B-2476-13","Class II","Wasp Venom Protein","A1200115; A1200052; A1200057; A1300029; M29636C; M31619A; A1200033; A1200104; A1300035; D29636B; D31619B; A1200009; A1200008; A1200096; A1300068; M29636A",,"16 Lots","Diluent containing phenol failed an apperance test on stability. The Diluent is included in the JHS licensed venomil kits that were distributed. ",7/3/2013,"07/03/2013",11/6/2013,"11/06/2013"
"Food",66062,"Ongoing","Jean's Cake","Carolina","PR","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","PR only.","F-1900-2013","Class II","Coffee Cake: queso/fresa (cheese/strawberry)","no codes",,,"Undeclared allergens: Yellow #5 and Yellow #6",8/16/2013,"08/16/2013",9/25/2013,"09/25/2013"
"Food",66062,"Ongoing","Jean's Cake","Carolina","PR","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","PR only.","F-1899-2013","Class II","Coffee Cake: queso crema (creme cheese)","no codes",,,"Undeclared allergens: Yellow #5 and Yellow #6",8/16/2013,"08/16/2013",9/25/2013,"09/25/2013"
"Food",66062,"Ongoing","Jean's Cake","Carolina","PR","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","PR only.","F-1898-2013","Class II","Coffee Cake: queso/guava (cheese/guava)","no codes",,"550 units","Undeclared allergens: Yellow #5 and Yellow #6",8/16/2013,"08/16/2013",9/25/2013,"09/25/2013"
"Food",66062,"Ongoing","Jean's Cake","Carolina","PR","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","PR only.","F-1901-2013","Class II","Coffee Cake: queso/manzana (cheese/apple)","no codes",,,"Undeclared allergens: Yellow #5 and Yellow #6",8/16/2013,"08/16/2013",9/25/2013,"09/25/2013"
"Devices",66063,"Ongoing","Endoplus, Inc.","Mundelein","IL","US","Voluntary: Firm Initiated","Letter","Distributed in the states of FL, TX, and VA.","Z-2265-2013","Class II","ENDOPLUS; Precision Laparoscopic Instruments; REF 345VA; Description 5 mm Traumatic Grasper S/A, Standard; Non-sterile; Manufactured by Endoplus; 750 Tower Rd., Suite A, Mundelein, IL 60060 USA. Intended for grasping, dissecting, retraction, clamping in conjunction with the laparoscopic during laparoscopic surgery.","Item: 345VA; Lot Number: F3",".","9 units","Multiple complaints reporting that the moveable jaw has broken during laparoscopic procedures.",7/15/2013,"07/15/2013",10/2/2013,"10/02/2013"
"Devices",66063,"Ongoing","Endoplus, Inc.","Mundelein","IL","US","Voluntary: Firm Initiated","Letter","Distributed in the states of FL, TX, and VA.","Z-2264-2013","Class II","ENDOPLUS; Precision Laparoscopic Instruments; REF 346VA; Description 5mm Atraumatic Grasper S/A, Standard; Non-sterile; Manufactured by Endoplus; 750 Tower Rd., Suite A, Mundelein, IL 60060 USA. Intended for grasping, dissecting, retraction, clamping in conjunction with the laparoscopic during laparoscopic surgery.","Item: 346VA; Lot Numbers: D3, E3, F3",".","81 units","Multiple complaints reporting that the moveable jaw has broken during laparoscopic procedures.",7/15/2013,"07/15/2013",10/2/2013,"10/02/2013"
"Drugs",66065,"Ongoing","Lupin Pharmaceuticals Inc.","Baltimore","MD","US","Voluntary: Firm Initiated","Letter","Nationwide","D-346-2014","Class III","Ethambutol Hydrochloride Tablets USP, 400 mg, 100-count bottles, Rx only, Manufactured for: Lupin Pharmaceuticals, Inc., Baltimore, Maryland 21202 United States; Manufactured by: Lupin Limited, Mumbai 400 098 INDIA, NDC 68180-281-01, UPC 3 68180 28101 6.","Lot #: 3122856, Exp 05/14",,"4896 bottles","Failed Impurities/Degradation Specifications: This product is being recalled due to an out of specification result for an impurity.",2/22/2013,"02/22/2013",12/18/2013,"12/18/2013"
"Devices",66067,"Ongoing","Carestream Health Inc.","Rochester","NY","US","Voluntary: Firm Initiated","Letter","Nationwide distribution:AL, AZ, AR, CA, CO, CT, DC, FL, GA, ID, IL, IN, IA, KS, KY, LA, MD, MA, MI, MN, MS, MI, MO, NE, NH, NJ, NM, NY, NC, OH, OK, OR, PA, RI, SC, TN, TX, UT, VT, VA, WA, WI, and WV.","Z-0180-2014","Class II","CARESTREAM DRX -Mobile Retrofit Kit, Catalog number: 1019397. Made in U.S.A. by Carestream Health, Inc. 150 Verona Street Rochester, NY 14608 to perform radiographic x-ray examinations on all pediatric and adult patients","Model: DRX Mobile Serial numbers: all serial numbers manufactured with version 5.5 software and version 69 firmware",".","364 units","Carestream Health Inc. has conducted a voluntary field action which includes the installation of a software patch on the following: DRX-Revolution Mobile X-Ray, DRX-Mobile and DRX Transportable Systems with DirectView Version 5.5 and 5.6 console software when used with DRX-1 Detector version 69 firmware. Carestream recently received reports of a non-diagnostic image on exams when a Normal Exposure Mode (NEM) image is taken immediately prior to an Extended Exposure Mode (EEM) image with the system in Fast Preview Mode. Investigation revealed that the DirectView version 5.5 and 5.6 console software when used with DRX-1 Detector version 69 firmware contained a timing issue which could result in a non-diagnostic image.",8/29/2013,"08/29/2013",11/13/2013,"11/13/2013"
"Devices",66067,"Ongoing","Carestream Health Inc.","Rochester","NY","US","Voluntary: Firm Initiated","Letter","Nationwide distribution:AL, AZ, AR, CA, CO, CT, DC, FL, GA, ID, IL, IN, IA, KS, KY, LA, MD, MA, MI, MN, MS, MI, MO, NE, NH, NJ, NM, NY, NC, OH, OK, OR, PA, RI, SC, TN, TX, UT, VT, VA, WA, WI, and WV.","Z-0179-2014","Class II","DRX- Revolution, Catalog number: 101937, 1023415 & 1023423. Made in U.S.A. by Carestream Health, Inc. 150 Verona Street Rochester, NY 14608 to perform radiographic x-ray examinations on all pediatric and adult patients","Model: DRXR-1 Serial numbers: all serial numbers manufactured with version 5.5 software and version 69 firmware",".","190 units","Carestream Health Inc. has conducted a voluntary field action which includes the installation of a software patch on the following: DRX-Revolution Mobile X-Ray, DRX-Mobile and DRX Transportable Systems with DirectView Version 5.5 and 5.6 console software when used with DRX-1 Detector version 69 firmware. Carestream recently received reports of a non-diagnostic image on exams when a Normal Exposure Mode (NEM) image is taken immediately prior to an Extended Exposure Mode (EEM) image with the system in Fast Preview Mode. Investigation revealed that the DirectView version 5.5 and 5.6 console software when used with DRX-1 Detector version 69 firmware contained a timing issue which could result in a non-diagnostic image.",8/29/2013,"08/29/2013",11/13/2013,"11/13/2013"
"Devices",66069,"Ongoing","Siemens Healthcare Diagnostics","Tarrytown","NY","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution-USA (nationwide) and the countries of Sweden, Switzerland, Taiwan, Turkey, United Kingdom, and Vietnam.","Z-0343-2014","Class II","ADVIA 1200 System Software: 1) V2.00, 2) V2.01. Performs assays for general and specialty chemistries, methods for specific protein measurement, drugs-of-abuse testing and therapeutic drug monitoring. ","Product Codes: 1) 10386841, 2) 10469445",,"625 units","Siemens Healthcare Diagnostics issued a Urgent Medical Device Correction due to Ration Parameters Flagging Behavior for All Software Versions utilized on ADVIA 1200, 1650, 1800 or 2400 Chemistry Systems.",9/3/2013,"09/03/2013",11/27/2013,"11/27/2013"
"Devices",66069,"Ongoing","Siemens Healthcare Diagnostics","Tarrytown","NY","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution-USA (nationwide) and the countries of Sweden, Switzerland, Taiwan, Turkey, United Kingdom, and Vietnam.","Z-0345-2014","Class II","ADVIA 1800 System Software V2.01. Performs assays for general and specialty chemistries, methods for specific protein measurement, drugs-of-abuse testing and therapeutic drug monitoring.","Product Code: 10639244",,"1366 units","Siemens Healthcare Diagnostics issued a Urgent Medical Device Correction due to Ration Parameters Flagging Behavior for All Software Versions utilized on ADVIA 1200, 1650, 1800 or 2400 Chemistry Systems.",9/3/2013,"09/03/2013",11/27/2013,"11/27/2013"
"Devices",66069,"Ongoing","Siemens Healthcare Diagnostics","Tarrytown","NY","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution-USA (nationwide) and the countries of Sweden, Switzerland, Taiwan, Turkey, United Kingdom, and Vietnam.","Z-0344-2014","Class II","ADVIA 1650 System Software: 1) V4.01, 2) V3.52. Performs assays for general and specialty chemistries, methods for specific protein measurement, drugs-of-abuse testing and therapeutic drug monitoring.","Product Codes: 1) 10318424, 2) 10285281",,"892 units","Siemens Healthcare Diagnostics issued a Urgent Medical Device Correction due to Ration Parameters Flagging Behavior for All Software Versions utilized on ADVIA 1200, 1650, 1800 or 2400 Chemistry Systems.",9/3/2013,"09/03/2013",11/27/2013,"11/27/2013"
"Devices",66069,"Ongoing","Siemens Healthcare Diagnostics","Tarrytown","NY","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution-USA (nationwide) and the countries of Sweden, Switzerland, Taiwan, Turkey, United Kingdom, and Vietnam.","Z-0346-2014","Class II","ADVIA 2400 System Software V4.01. Performs assays for general and specialty chemistries, methods for specific protein measurement, drugs-of-abuse testing and therapeutic drug monitoring.","Product Code: 10639265",,"876 units","Siemens Healthcare Diagnostics issued a Urgent Medical Device Correction due to Ration Parameters Flagging Behavior for All Software Versions utilized on ADVIA 1200, 1650, 1800 or 2400 Chemistry Systems.",9/3/2013,"09/03/2013",11/27/2013,"11/27/2013"
"Devices",66070,"Ongoing","Becton Dickinson & Company","Franklin Lakes","NJ","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Worldwide Distribution - USA including FL, VA, TX, NY, IL, AZ, MI, RI, NJ, SC, MO, TN, CA, MN, UT, GA, NE, OH, MD, PA, MT and internationally to Brazil, Australia, Canada, and Puerto Rico..","Z-2274-2013","Class II","BD Epilor Syringe BD Franklin Lakes, NJ 07417 BD EDC Laagstraat 57, B-9140 Temse-Belgium The Epilor syringe is used in conjunction with an epidural needle with the purpose of finding the epidural space.","510K K925902 D041521 Catalog Number: 405198 Lots 8310086 9246684 0035495 0053165 0056608 0056607 0096757 0120074 0126127 0152581 0242475 0258468 0258469 0258472 0291220 0291221 0291223 0291224 0278495 0291218 0291219 0291222 0291226 0291227 0291228 0336391 0336393 0336396 0336400 1005321 1006136 1033177 1033178 1094304 1209634 1210646 1213990 1213993 1276782 1307383 2032802 2033712 2060835 2065940 2084318 2121011 2122467 2205098 2212313 2276066 3038272 3042376 3063436 3063440 3085498 3085001 3085003 3085005 3123462 3123246 3184092 Catalog Number 405291 Lots 0154661 0174905 0252565 0279140 0301813 0347866 1012200 1035046 1063738 1095340 1124755 1180073 1213029 1262268 1273795 1312116 1320204 1356378 2041210 2058524 2083246 2135469 2158092 2170207 2194139 2205106 2223162 2223337 2250088 2286395 2303137 2303141 2334338 2334339 2355389 2355391 3057376 3120039 Catalog Number 405807 Lots GD873422 GD874743 GD875419 GD876029 GD876912 GD879577 GD881128 GD883033 Catalog Number 405823 Lots GD877068 GD882951 GD884312 GD885491 GD886192 GD887893 GD889527 B01F223D B01F243D B01G057D B01G196D Catalog Number 406078; Lots GD876003 GD877787 GD881169 GD883017 GD883660 GD885202 GD886283 GD888677 GD890442 B01F054D B02F156D B02F178D B03F074D B03F241D Catalog number 406084 Lots B03F090D B06F326D GD875369 GD880427 GD883025 GD888255 B05G087D Catalog # 406119 Lots GD873364 GD875625 GD877878 GD879015 GD881813 GD885129 GD889782 B02F051D B02F096D B01F135D B03F222D Catalog # 406121 Lots GD887596 GD889618 Catalog # 406156 Lots GD887778 GD889733 GD889980 GD890178 B02F214D B02F292D B02G157D B03F292D B03G158D B04F238D B05F241D ",".","1,335,885 units","BD has received several reports indicating that the plunger of the 7 mL BD Epilor plastic BD Luer-Lok Loss of Resistance Syringe may stall or stick within the syringe preventing the user from detecting a loss of resistance upon entering the epidural space.",8/23/2013,"08/23/2013",10/2/2013,"10/02/2013"
"Biologics",66071,"Terminated","St Mary's Hospital and Medical Center, Inc.","Grand Junction","CO","US","Voluntary: Firm Initiated","Telephone","Colorado","B-2517-13","Class II","Red Blood Cells Leukocytes Reduced","W056313000110; ",,"1","Blood product, collected from a donor who received a body piercing within 12 months of donating, was distributed.",12/28/2012,"12/28/2012",11/27/2013,"11/27/2013"
"Biologics",66072,"Terminated"," Lions Eye Bank For Long Island ","Valley Stream","NY","US","Voluntary: Firm Initiated","Letter","New York","B-2328-13","Class III","Cornea","2011233C; 2011234C",".","2 corneas","Human corneas, recovered from a donor whose donor eligibility determination failed to ensure that the donor was free from risk factors for, and clinical evidence of infection due to relevant communicable disease agents and diseases, were distributed. ",7/13/2013,"07/13/2013",11/13/2013,"11/13/2013"
"Biologics",66073,"Terminated"," Lions Eye Bank For Long Island ","Valley Stream","NY","US","Voluntary: Firm Initiated","Letter","New York","B-2329-13","Class III","Cornea","2011239C; 2011240C",".","2 corneas","Human corneas, recovered from a donor whose donor eligibility determination failed to ensure that the donor was free from risk factors for, and clinical evidence of infection due to relevant communicable disease agents and diseases, were distributed. ",7/13/2013,"07/13/2013",11/13/2013,"11/13/2013"
"Biologics",66074,"Terminated"," Lions Eye Bank For Long Island ","Valley Stream","NY","US","Voluntary: Firm Initiated","Letter","New York","B-2330-13","Class III","Cornea","2011153C; 2011154C",".","2 corneas","Human corneas, recovered from a donor whose donor eligibility determination failed to ensure that the donor was free from risk factors for, and clinical evidence of infection due to relevant communicable disease agents and diseases, were distributed. ",7/13/2013,"07/13/2013",11/13/2013,"11/13/2013"
"Biologics",66075,"Terminated"," Lions Eye Bank For Long Island ","Valley Stream","NY","US","Voluntary: Firm Initiated","Letter","New York","B-2331-13","Class III","Cornea","201117C; 201118C",".","2 corneas","Human corneas, recovered from a donor whose donor eligibility determination failed to ensure that the donor was free from risk factors for, and clinical evidence of infection due to relevant communicable disease agents and diseases, were distributed. ",7/13/2013,"07/13/2013",11/13/2013,"11/13/2013"
"Biologics",66076,"Terminated"," Lions Eye Bank For Long Island ","Valley Stream","NY","US","Voluntary: Firm Initiated","Letter","New York","B-2332-13","Class II","Cornea","2010399C; 2010400C",".","2 corneas","Human corneas, recovered from a donor whose donor eligibility determination failed to ensure that the donor was free from risk factors for, and clinical evidence of infection due to relevant communicable disease agents and diseases, were distributed. ",7/13/2013,"07/13/2013",11/13/2013,"11/13/2013"
"Biologics",66077,"Terminated"," Lions Eye Bank For Long Island ","Valley Stream","NY","US","Voluntary: Firm Initiated","Letter","New York","B-2333-13","Class III","Cornea","2010372C; 2010371C",".","2 corneas","Human corneas, recovered from a donor whose donor eligibility determination failed to ensure that the donor was free from risk factors for, and clinical evidence of infection due to relevant communicable disease agents and diseases, were distributed. ",7/13/2013,"07/13/2013",11/13/2013,"11/13/2013"
"Biologics",66078,"Terminated"," Lions Eye Bank For Long Island ","Valley Stream","NY","US","Voluntary: Firm Initiated","Letter","North Carolina; New York","B-2552-13","Class III","Cornea","201005C; 201006C",".","2 corneas","Human corneas, recovered from a donor whose donor eligibility determination failed to ensure that the donor was free from risk factors for, and clinical evidence of infection due to relevant communicable disease agents and diseases, were distributed. ",7/13/2013,"07/13/2013",11/13/2013,"11/13/2013"
"Biologics",66079,"Terminated"," Lions Eye Bank For Long Island ","Valley Stream","NY","US","Voluntary: Firm Initiated","Letter","New York","B-2553-13","Class III","Cornea","2010381C",".","1 cornea","Human cornea, recovered from a donor whose donor eligibility determination failed to ensure that the donor was free from risk factors for, and clinical evidence of infection due to relevant communicable disease agents and diseases, was distributed. ",7/13/2013,"07/13/2013",11/13/2013,"11/13/2013"
"Food",66081,"Ongoing","G. Debbas Chocolatier, Inc. ","Fresno","CA","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","One customer in Chicago, IL","F-1888-2013","Class I","Professor Zim Zam's Extraordinary Sweets; Dark Chocolate with Rice Crisps; All Natural, 55% Cocoa; Net Wt. 0.35 oz (9.9g) Go Picnic: Distributed by Go Picnic Brands, Chicago, IL 60613; Made in USA","UPC: 8 90026 00220 7 All codes.",,"107,500 units at customers warehouse","Two consumer complaints of allergic reactions for Zim Zam products packed in a picnic type lunch that declares it is vegan. G. Debbas Chocolatier does not claim that their product facility is vegan, as they do make product that contain milk.",8/19/2013,"08/19/2013",9/25/2013,"09/25/2013"
"Food",66081,"Ongoing","G. Debbas Chocolatier, Inc. ","Fresno","CA","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","One customer in Chicago, IL","F-1889-2013","Class I","Professor Zim Zam's Extraordinary Sweets; Dark Chocolate with Orange; All Natural, 55% Cocoa; Net Wt. 0.35 oz (9.9g) Go Picnic: Distributed by Go Picnic Brands, Chicago, IL 60613; Made in USA","UPC: 8 90026 00219 1 All codes.",,"126,600 pieces at customers warehouse","Two consumer complaints of allergic reactions for Zim Zam products packed in a picnic type lunch that declares it is vegan. G. Debbas Chocolatier does not claim that their product facility is vegan, as they do make product that contain milk.",8/19/2013,"08/19/2013",9/25/2013,"09/25/2013"
"Food",66081,"Ongoing","G. Debbas Chocolatier, Inc. ","Fresno","CA","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","One customer in Chicago, IL","F-1887-2013","Class I","Professor Zim Zam's Extraordinary Sweets; Dark Chocolate with Sea Salt; All Natural, 55% Cocoa; Net Wt. 0.35 oz (9.9g) Go Picnic: Distributed by Go Picnic Brands, Chicago, IL 60613; Made in USA","UPC: 8 90026 00218 4 All codes.",,"162,708 units at customers warehouse","Two consumer complaints of allergic reactions for Zim Zam products packed in a picnic type lunch that declares it is vegan. G. Debbas Chocolatier does not claim that their product facility is vegan, as they do make product that contain milk.",8/19/2013,"08/19/2013",9/25/2013,"09/25/2013"
"Devices",66082,"Ongoing","Baxa Corporation","Englewood","CO","US","Voluntary: Firm Initiated","Letter","Distributed to One Customer in NC.","Z-2165-2013","Class II","Baxa Vial Adapter, 14mm - Luer Lock, Order No. REF: 90, Quantity: 50 each, Single Use. Product Code H93890. Used as a needleless access device for reconstitution and drug transfer. ","Lot or Serial No. 785518",".","34 cases","Baxter Healthcare Corporation is voluntarily recalling one lot of Baxa Vial Adapters, 14mm - Luer Lock, due to incorrect expiry date.",8/22/2013,"08/22/2013",9/18/2013,"09/18/2013"
"Drugs",66083,"Ongoing","South Coast Specialty Compounding, Inc.","Irvine","CA","US","Voluntary: Firm Initiated","Press Release","CA, IN","D-1027-2013","Class II","Testosterone Cypionate (Sesame Oil) 200mg/mL for injection in 10mL amber vials, Park Compounding, Irvine, CA"," Lot #05072013@1, Exp 11/3/2013",".",,"Lack of Assurance of Sterility: Park Compounding is voluntarily recalling two lots of Methylcobalamin 5mg/ml and Multitrace-5 Concentrate, and one lot of Testosterone Cypionate (sesame oil) for injection due lack of sterility assurance.",8/23/2013,"08/23/2013",9/18/2013,"09/18/2013"
"Drugs",66083,"Ongoing","South Coast Specialty Compounding, Inc.","Irvine","CA","US","Voluntary: Firm Initiated","Press Release","CA, IN","D-1025-2013","Class II","Methylcobalamin Injection 5 mg/mL, For IM or SC Administration, Sterile 30 mL Multiple Dose Vial, Park Compounding, Irvine, CA","Lot #06132013@1, Exp 12/10/2013",".","297 vials","Lack of Assurance of Sterility: Park Compounding is recalling Methylcobalamin 5 mg/mL, Multitrace-5 Concentrate, and Testosterone Cypionate (sesame oil) for injection due to lack of sterility assurance.",8/23/2013,"08/23/2013",9/18/2013,"09/18/2013"
"Drugs",66083,"Ongoing","South Coast Specialty Compounding, Inc.","Irvine","CA","US","Voluntary: Firm Initiated","Press Release","CA, IN","D-1026-2013","Class II","Multitrace-5 Concentrate (Trace Elements -5 Conc Injection) Solution, Sterile 10mL Multiple Dose Vial, For Slow IV Administration After Dilution Only, Park Compounding, Irvine, CA"," Lot #05212013@20 and Lot#03212013@6, Exp 11/17/2013",".","82 vials","Lack of Assurance of Sterility: Park Compounding is recalling Methylcobalamin 5 mg/mL, Multitrace-5 Concentrate, and Testosterone Cypionate (sesame oil) for injection due to lack of sterility assurance.",8/23/2013,"08/23/2013",9/18/2013,"09/18/2013"
"Drugs",66084,"Ongoing","Creative Compounds","Wilsonville","OR","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Oregon and Washington","D-1019-2013","Class II","Glutathione 100 mg/mL Injectable, 100mL Vial, Use as Directed, RX, Creative Compounds, Wilsonville, OR 97070.","Lot #: 20130715@12, Exp10/13/2013",".","16 vials","Glutathione 100 mg/mL injectable human drug is recalled due to Out Of Specification results or potential bacterial contamination and it was reported as passing by a contract laboratory. ",8/23/2013,"08/23/2013",9/18/2013,"09/18/2013"
"Food",66085,"Ongoing","Conagra Inc","Omaha","NE","US","Voluntary: Firm Initiated","Press Release","Distribution was made to: Alabama, Alaska, Arizona, California, Georgia, Idaho, Illinois, Indiana, Kansas, Kentucky, Michigan, Missouri, Montana, Nebraska, Nevada, New Mexico, North Carolina, Ohio, Oregon, South Carolina, Tennessee, Utah, Virginia, Washington, West Virginia and Wyoming.","F-1866-2013","Class I","Kroger Break 'N Bake Chocolate Chip Cookie Dough, refrigerated dough, packaged in 16.0 oz. plastic package. ","Date code: 24NOV13C21",".","1,073 /8/16 oz package/cases","Peanut Butter Cup Cookie Dough (refrigerated) is packaged in Chocolate Chip Cookie Dough packaging. Peanuts or peanut butter are not listed on the ingredient list or allergen statement.",8/25/2013,"08/25/2013",9/11/2013,"09/11/2013"
"Biologics",66086,"Terminated","San Diego Blood Bank","San Diego","CA","US","Voluntary: Firm Initiated","Telephone","CA","B-2569-13","Class III","Red Blood Cells Leukocytes Reduced","W044213852164",,"1 unit","Blood product, collected from a donor with no documentation of an arm inspection, was distributed.",7/31/2013,"07/31/2013",11/27/2013,"11/27/2013"
"Biologics",66087,"Terminated","American National Red Cross (The) - North Central Region","Saint Paul","MN","US","Voluntary: Firm Initiated","Telephone","GA","B-2081-13","Class II","Red Blood Cells (Apheresis) Leukocytes Reduced","017GW71663; 017GW71665 ",,"2 units","Blood products, possibly contaminated with air, were distributed.",7/1/2013,"07/01/2013",11/27/2013,"11/27/2013"
"Biologics",66088,"Terminated","American Red Cross Blood Services Tennessee Valley Region","Nashville","TN","US","Voluntary: Firm Initiated","Telephone","Tennessee","B-0006-14","Class III","Red Blood Cells Leukocytes Reduced","W20191300759300; ",,"1","Blood component, prepared from Whole Blood that was centrifuged at room temperature, was distributed.",4/8/2013,"04/08/2013",12/18/2013,"12/18/2013"
"Biologics",66089,"Terminated","The Aroostook Medical Center Blood Bank","Presque Isle","ME","US","Voluntary: Firm Initiated","E-Mail","Maine","B-2579-13","Class II","Red Blood Cells (Apheresis) Leukocytes Reduced Irradiated","04GN24339; ",,"1","Blood product, incorrectly identified as Jka negative, was distributed.",5/9/2013,"05/09/2013",11/27/2013,"11/27/2013"
"Biologics",66090,"Terminated"," Lions Eye Bank For Long Island ","Valley Stream","NY","US","Voluntary: Firm Initiated","Letter","Egypt; New York","B-2485-13","Class II","Cornea","2011251C; 2011252C",".","2 corneas","Human corneas, recovered from a donor whose donor eligibility determination failed to ensure that the donor was free from risk factors for, and clinical evidence of infection due to relevant communicable disease agents and diseases, were distributed. ",7/13/2013,"07/13/2013",11/20/2013,"11/20/2013"
"Biologics",66091,"Terminated"," Lions Eye Bank For Long Island ","Valley Stream","NY","US","Voluntary: Firm Initiated","Letter","Mexico; New York","B-2488-13","Class III","Cornea","2011293C; 2011294C",".","2 corneas","Human corneas, recovered from a donor whose donor eligibility determination failed to ensure that the donor was free from risk factors for, and clinical evidence of infection due to relevant communicable disease agents and diseases, were distributed. ",7/13/2013,"07/13/2013",11/20/2013,"11/20/2013"
"Biologics",66093,"Terminated"," Lions Eye Bank For Long Island ","Valley Stream","NY","US","Voluntary: Firm Initiated","Letter","New York","B-2486-13","Class II","Cornea","2011366C; 2011365C",".","2 corneas","Human corneas, recovered from a donor whose donor eligibility determination failed to ensure that the donor was free from risk factors for, and clinical evidence of infection due to relevant communicable disease agents and diseases, were distributed. ",7/13/2013,"07/13/2013",11/20/2013,"11/20/2013"
"Biologics",66094,"Terminated"," Lions Eye Bank For Long Island ","Valley Stream","NY","US","Voluntary: Firm Initiated","Letter","New York","B-2489-13","Class III","Cornea","2011344C",".","1 cornea","Human cornea, recovered from a donor whose donor eligibility determination failed to ensure that the donor was free from risk factors for, and clinical evidence of infection due to relevant communicable disease agents and diseases, was distributed. ",7/13/2013,"07/13/2013",11/20/2013,"11/20/2013"
"Biologics",66095,"Terminated"," Lions Eye Bank For Long Island ","Valley Stream","NY","US","Voluntary: Firm Initiated","Letter","Venezuela; New York","B-2490-13","Class III","Cornea","2011321C; 2011322C",".","2 corneas","Human corneas, recovered from a donor whose donor eligibility determination failed to ensure that the donor was free from risk factors for, and clinical evidence of infection due to relevant communicable disease agents and diseases, were distributed. ",7/13/2013,"07/13/2013",11/20/2013,"11/20/2013"
"Biologics",66096,"Terminated"," Lions Eye Bank For Long Island ","Valley Stream","NY","US","Voluntary: Firm Initiated","Letter","New York","B-2549-13","Class III","Cornea","2011285C; 2011286C",".","2 corneas","Human corneas, recovered from a donor whose donor eligibility determination failed to ensure that the donor was free from risk factors for, and clinical evidence of infection due to relevant communicable disease agents and diseases, were distributed.",7/13/2013,"07/13/2013",11/13/2013,"11/13/2013"
"Devices",66098,"Ongoing","Ebi, Llc","Parsippany","NJ","US","Voluntary: Firm Initiated","Letter","Nationwide Distribution (US), including the states of IN, MD, MS, NC, OH, PA, SC, and TX.","Z-2214-2013","Class II","Cypher MIS Screw System, Biomet Spine Parsippany, NJ 07054. The Cypher MIS Screw System is a non-cervical spinal fixation device. 1)Screw Tower - REF 14-501660 2) Rod Reduce - REF 14-501661 3) Counter Torque - REF 14-501662 ","14-501660 Screw Tower Lots IT0024 IT0025 IT0026 IT0027 IT0028 IT0029 14-501661 Rod Reducer Lots IT0015 IT0022 IT0023 14-501662 Counter Torque Lots IT0020 IT0021",,"427 units","Several complaints were reported to exhibit screw head splay in the Cypher MIS Screw System.",8/13/2013,"08/13/2013",9/25/2013,"09/25/2013"
"Drugs",66099,"Ongoing","JCB Labs LLC","Wichita","KS","US","Voluntary: Firm Initiated","Telephone","Nationwide and Guam","D-1046-2013","Class II","Sodium Citrate 4% Solution for Injection, 30 mL Multi Dose Vial, Sterile Solution for Office Use Only, JCB Laboratories, Wichita, KS.","Lot # 130710@4, Exp. 01/06/2014",,"677 vials","Lack of Assurance of Sterility: The product lots are being recalled due to laboratory results (from a contract lab) indicating microbial contamination. The FDA was concerned test results obtained from the recalling firm's contract testing lab may not be reliable. Hence the sterility of the products cannot be assured. ",8/23/2013,"08/23/2013",9/25/2013,"09/25/2013"
"Drugs",66099,"Ongoing","JCB Labs LLC","Wichita","KS","US","Voluntary: Firm Initiated","Telephone","Nationwide and Guam","D-1047-2013","Class II","Epinephrine 1:1,000 (1mg/mL) Sterile Solution for injection, Preservative Free/Sulfite Free, 1-mL Single-Use Syringe, Sterile Solution For Office Use Only, JCB Laboratories, Wichita, KS."," Lot # 130806@2, Expiry 09/20/2013.",,"1243 Syringes","Lack of Assurance of Sterility: The product lots are being recalled due to laboratory results (from a contract lab) indicating microbial contamination. The FDA was concerned test results obtained from the recalling firm's contract testing lab may not be reliable. Hence the sterility of the products cannot be assured. ",8/23/2013,"08/23/2013",9/25/2013,"09/25/2013"
"Drugs",66099,"Ongoing","JCB Labs LLC","Wichita","KS","US","Voluntary: Firm Initiated","Telephone","Nationwide and Guam","D-1043-2013","Class II","Acetylcysteine 20% Solution, Preservative Free, 4 mL Sterile Single Dose Vial, Not for Injection, Sterile Solution For Office Use Only, JCB Laboratories, Wichita, KS.","Lot # 130627@5, Exp 08/26/2013",,"903 vials","Lack of Assurance of Sterility: The product lots are being recalled due to laboratory results (from a contract lab) indicating microbial contamination. The FDA was concerned test results obtained from the recalling firm's contract testing lab may not be reliable. Hence the sterility of the products cannot be assured. ",8/23/2013,"08/23/2013",9/25/2013,"09/25/2013"
"Drugs",66099,"Ongoing","JCB Labs LLC","Wichita","KS","US","Voluntary: Firm Initiated","Telephone","Nationwide and Guam","D-1045-2013","Class II","Sodium Citrate 4% containing Gentamicin 320 mcg/mL, Solution for Injection, 30 mL Multi Dose Vial, Sterile Solution For Office Use Only, JCB Laboratories, Wichita, KS.","Lot # 130620@2, Exp 12/17/2013",,"397 vials","Lack of Assurance of Sterility: The product lots are being recalled due to laboratory results (from a contract lab) indicating microbial contamination. The FDA was concerned test results obtained from the recalling firm's contract testing lab may not be reliable. Hence the sterility of the products cannot be assured. ",8/23/2013,"08/23/2013",9/25/2013,"09/25/2013"
"Drugs",66099,"Ongoing","JCB Labs LLC","Wichita","KS","US","Voluntary: Firm Initiated","Telephone","Nationwide and Guam","D-1044-2013","Class II","Sodium Thiosulfate 25%, 250 mg/mL (12.5 g/50mL), PF Sterile Solution for Injection, 50 mL Single Dose Vial, For Office Use Only, JCB Laboratories, Wichita, KS.","Lot #: 130701@9, Exp 12/28/2013; 130709@6, Exp 01/05/2014; 130717@2, Exp 01/13/2014",,"1056 vials","Lack of Assurance of Sterility: The product lots are being recalled due to laboratory results (from a contract lab) indicating microbial contamination. The FDA was concerned test results obtained from the recalling firm's contract testing lab may not be reliable. Hence the sterility of the products cannot be assured. ",8/23/2013,"08/23/2013",9/25/2013,"09/25/2013"
"Drugs",66100,"Ongoing","Pharmacy Creations","Randolph","NJ","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","NJ","D-1028-2013","Class II","Lidocaine 1% PF Sterile Injection, 30 mL Single Dose Vial, Pharmacy Creations, Randolph, NJ.","Lot # 214490.00, Exp 11/29/2013",".","50 vials","Lack of Assurance of Sterility: Pharmacy Creations is recalling Lidocaine 1% PF Sterile Injection and EDTA disodium 150 mg/mL due to lack of assurance of sterility.",8/26/2013,"08/26/2013",9/18/2013,"09/18/2013"
"Drugs",66100,"Ongoing","Pharmacy Creations","Randolph","NJ","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","NJ","D-1029-2013","Class II","EDTA disodium 150 mg/mL Sterile Injection, 20 mL Multi Dose Vial, Pharmacy Creations, Randolph, NJ 07869","Lot # 070213Z, Exp 1/2/2014",".","75 vials","Lack of Assurance of Sterility: Pharmacy Creations is recalling Lidocaine 1% PF Sterile Injection and EDTA disodium 150 mg/mL due to lack of assurance of sterility.",8/26/2013,"08/26/2013",9/18/2013,"09/18/2013"
"Devices",66101,"Ongoing","Bayer Healthcare Llc","Sunnyvale","CA","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution - USA (nationwide) and Internationally to China, Argentina, Uruguay, Japan.","Z-0136-2014","Class II","Bayer brand A1CNow+ MULTI-TEST A1C SYSTEM TEST KITS (PART NUMBER 3021/08842610); Hemoglobin A1c Monitor; Glycosylated Hemoglobin Assay; Product is manufactured and distributed by Bayer HealthCare LLC, Sunnyvale, CA The A1CNow+ test provides quantitative measurement of the percent of glycated hemoglobin (%HbA1c or %A1C) levels in capillary (fingerstick) or venous whole blood samples. The test is for professional use to monitor glycemic control in people with diabetes.","Lot: 1300733 (US, China); Lot: 1300712 (Argentina, Uruguay); Lots: 1300711, 130012 (Japan) ",".","138 Kits in US (Total 2452)","Test results from these lots may produce a high-bias reading (by up to 20%) that is outside of limits defined for stability and product accuracy when product is stored at room temperature four (4) to five (5) months after release.",8/26/2013,"08/26/2013",11/13/2013,"11/13/2013"
"Food",66102,"Ongoing","Gourmet Express Marketing, Inc.","Addison","IL","US","Voluntary: Firm Initiated","Telephone","US: Nationwide (IL, IN, MI, MO, NY, OH)","F-1913-2013","Class II","Breaded, frozen shrimp packaged in plastic bags labeled in part: BREADED SHRIMP; NET WEIGHT; 2.0 LBS or 3 LBS","Lot Code: 6483004",".","856 lbs in 2 and 3 lbs units","Packages of breaded shrimp failed to declare shellfish (shrimp) and wheat allergens.",8/1/2013,"08/01/2013",10/2/2013,"10/02/2013"
"Drugs",66103,"Ongoing","Leiter's Pharmacy","San Jose","CA","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Nationwide","D-1038-2013","Class II","Dextrose 50% Preservative Free SDV Injection Solution, 50 mL Single dose vial, IV Administration, Compounded by Leiter's Compounding Pharmacy, 1700 Park Ave., # 30, San Jose, CA 95126","Lot 06072013@49, Exp 9/5/13",,"56 vials","Lack of Assurance of Sterility: Leiter Pharmacy is recalling due bacterial contamination found after investigation at contract testing laboratory discovered that OOS results were reported to customers as passing. Hence the sterility of these products cannot be assured. ",8/26/2013,"08/26/2013",9/25/2013,"09/25/2013"
"Drugs",66103,"Ongoing","Leiter's Pharmacy","San Jose","CA","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Nationwide","D-1041-2013","Class II","Lidocaine/Phenylephrine PF 1%/1.5% Injectible vials, 1 mL Single Use Vial, Compounded by Leiter's Compounding Pharmacy, 1700 Park Ave., # 30, San Jose, CA 95126","Lot # : 07302013@6 Exp 10/28/13 ",,"728 vials","Lack of Assurance of Sterility: Leiter Pharmacy is recalling due bacterial contamination found after investigation at contract testing laboratory discovered that OOS/failed results were reported to customers as passing. Hence the sterility of these products cannot be assured. ",8/26/2013,"08/26/2013",9/25/2013,"09/25/2013"
"Drugs",66103,"Ongoing","Leiter's Pharmacy","San Jose","CA","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Nationwide","D-1039-2013","Class II","Hyaluron (hyaluronidase) 150 units/mL Preserved Solution, 1 mL, Multi Dose Vial, Compounded by Leiter's Compounding Pharmacy, 1700 Park Ave., # 30, San Jose, CA 95126","Lot #: 06122013@9; Exp 9/10/13",,"810 vials","Lack of Assurance of Sterility: Leiter Pharmacy is recalling due bacterial contamination found after investigation at contract testing laboratory discovered that OOS results were reported to customers as passing. Hence the sterility of these products cannot be assured. ",8/26/2013,"08/26/2013",9/25/2013,"09/25/2013"
"Drugs",66103,"Ongoing","Leiter's Pharmacy","San Jose","CA","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Nationwide","D-1040-2013","Class II","Bevacizumab (Avastin) 2.5mg/0.1mL PF Inj., 0.1 mL syringe, Compounded by Leiter's Compounding Pharmacy, 1700 Park Ave., # 30, San Jose, CA 95126","Lot #: 08052013@1, 08052013@4, Exp 11/03/2013 ",,"265 vials ","Lack of Assurance of Sterility: Leiter Pharmacy is recalling due bacterial contamination found after investigation at contract testing laboratory discovered that OOS/failed results were reported to customers as passing. Hence the sterility of the products cannot be assured. ",8/26/2013,"08/26/2013",9/25/2013,"09/25/2013"
"Drugs",66104,"Ongoing","Hospira Inc.","Lake Forest","IL","US","Voluntary: Firm Initiated","Letter","Nationwide and Puerto Rico","D-927-2013","Class II","Diazepam Injection, USP, 5 mg/mL, 10 mL, Multiple-dose Sterile Non-pyrogenic, Fliptop Vial, C-IV, Rx Only, Hospira, Inc., Lake Forest, IL 60045, USA, NDC 0409-3213-12","Lot: 23-505-EV, Exp. 11/14",,"72,300 vials","Lack of assurance of sterility: ineffective crimp on fliptop vials that may result in leaking at the neck of the vials.",8/16/2013,"08/16/2013",9/4/2013,"09/04/2013"
"Devices",66105,"Ongoing","OPTI Medical Systems, Inc","Roswell","GA","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Worldwide distribution: US (nationwide) including states of: CA, MA, MN, and VA; and countries of: China, Guatemala, India, Iraq, South Korea, and Untied Arab Emirates.","Z-0029-2014","Class II","Model BP7507 OPTI LION E-Plus Cassettes 25 Cassettes with Sample Probes, OPTIMedical Cassettes are consumable used in the OPTI LION Electrolyte Analyzer intended to be used for the measurement of sodium, potassium, chloride, ionized calcium and pH in samples of whole blood, serum, and plasma.","Lots 252810, 315815, 319810, 319815, 321817, 367812, 370812",".","361 boxes of 25 cassettes each"," OPTI LION E-Plus Cassettes were labeled with an incorrect barcode. The incorrect barcode could perfect the performance of one or more parameters as the product ages. Also a Customer complaint from a distributor reported that a customer was getting QC failures.",8/9/2013,"08/09/2013",10/30/2013,"10/30/2013"
"Biologics",66106,"Terminated","West Tennessee Regional Blood Center Inc","Jackson","TN","US","Voluntary: Firm Initiated","Telephone","Tennessee","B-2578-13","Class II","Platelets Pheresis Leukocytes Reduced","W040813600738; ",,"1","Blood product, with no documentation of QC testing for platelet pH, was distributed.",8/8/2013,"08/08/2013",11/27/2013,"11/27/2013"
"Food",66107,"Ongoing","KDK Management, Inc., dba Bubbles Baking Co.","Van Nuys","CA","US","Voluntary: Firm Initiated","Letter","CA, NV, AZ","F-1878-2013","Class I","First Street Coffee Cake Muffins (S 45398) 4 count 14 oz. UPC 0 4151210848 8","Lot# 12310,12315, 12320,1321, 12335, 12344,12348,12349,12349, 12361,13007, 13007, 13007, 13029,13032, 13032, 13035, 13036, 13053, 13063, 13065, 13066, 13099, 13114, 13123, 13124, 13133, 13134, 13136, 13137, 13141, 13142, 13142, 13151, 13155, 13162, 13162, 13171, 13176, 13177, 13182, 13186, 13187, 13193, 13196, 13203, 13207, 13210, 13217, 13227, 13222, 13229.",".","8478 units","Bubbles Baking Co. is recalling coffee cake muffins because it may contain undeclared pecan nuts.",8/26/2013,"08/26/2013",9/18/2013,"09/18/2013"
"Devices",66108,"Completed","Radiometer America Inc","Westlake","OH","US","Voluntary: Firm Initiated","Letter","Nationwide Distribution, including the states of: AK, AL, AR, AZ, BM, CA, CO, CT, DC, FL, GA, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, WA, WI and WV.","Z-2303-2013","Class II","Lactate Membrane units for E7077 Electrode Radiometer Medical ApS. The intended use is in vitro testing of samples of whole blood.","Part Number: 942-066 R1741 to R1869",,"13,632 boxes/4 membranes","RADIOMETER became aware that some membranes may have enzyme residue on the outer membrane. The enzyme residue may cause an initial negative bias on the reported Lactate result upon replacement of the Lactate membrane. ",10/8/2012,"10/08/2012",10/9/2013,"10/09/2013"
"Food",66109,"Ongoing","Crown Pacific Int'L Llc","Hilo","HI","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","One distributor in both CO and VA","F-1873-2013","Class III","Hawaii Fresh Sweet Basil Hawaii Fresh Thai Basil product of the USA Crown Pacific International, Inc. Hilo, HI","no code informtion",".","56 boxes of sweet basil (14, 15 or 16 lbs per box); 16 boxes of Thai basil (15 or 16 lbs per box)","State of Hawaii Issued a Cease and Desist Order to grower of basil for positive sample results for pesticides not allowed on basil.",8/23/2013,"08/23/2013",9/11/2013,"09/11/2013"
"Devices",66110,"Completed","Sybron Dental Specialties","Orange","CA","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution - USA Nationwide and the countries of Australia, Canada, and EU.","Z-2195-2013","Class II","AOA Mini RPE Screw Assembly , a component of Herbst, MARA and Fixed Metal devices. Product Usage: AOA Mini RPE Screw Assembly is a component of Herbst, MARA and Fixed Metal devices; removable functional appliances that are to modify the growth of the jaws in a prescribed growth pattern, however, this category is generally attached to the patients upper and lower molars or bicuspids by means of temporary stainless steel crowns or orthodontic bands. Retainer, Screw Expansion, Orthodontic. ","The AOA Mini RPE Screw Assembly is a component used in customized palate expander appliances assembled by prescription. The affected assembly may be found in products listed in the table below: Product Description: Herbst Bite Jumper Herbst Appliance Acrylic Splint M.A.R.A. (Mandibular Anterior Reposi tioning Appliance) Rapid Palatal Expander Lower Expander DeLuke Bonded Frameless Expander Haas Expander AOA Mini Rapid Palatal Expander Dischinger Lower Expansion Appliance Tracy/Hilgers MDA Appliance Distal Jet Molar Uprighter Part Number: 3000-0010 3000-0011 3000-0012 3000-0040 3000-0042 3000-0045 3000-0046 3000-0047 3000-0050 3000-0094 3000-0097 Lot Number: ''All Devices Manufactured from April 3, 2013 to May 21, 2013'' ",".","1,091","The firm initiated the recall of AOA Mini RPE Screw Assembly, because it may be missing a complete weld joining one side of the arm with the screw body. Herbst, MARA and Fixed Metal devices may be affected, because they contain an AOA Mini RPE Screw Assembly.",6/6/2013,"06/06/2013",9/18/2013,"09/18/2013"
"Devices",66111,"Ongoing","GE Healthcare, LLC","Waukesha","WI","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution-USA including the states of IL, MN, NJ, NY, and VA, and the countries of ALGERIA, AUSTRALIA, BELGIUM, BRAZIL, CANADA, DENMARK, FINLAND, FRANCE, GERMANY, GUADELOUPE, INDIA, INDONESIA, ISRAEL, ITALY, JAPAN,KOREA, LATVIA, MARTINIQUE, NETHERLANDS, NORWAY, PHILIPPINES,S POLAND, REUNION, ROMANIA, RUSSIA, SAUDI ARABIA, SINGAPORE, SOUTH AFRICA, SPAIN, SWEDEN SWITZERLAND, THAILAND, TUNISIA, TURKEY, UNITED KINGDOM, and VIETNAM.","Z-2241-2013","Class II","GE Healthcare, Advantage Workstation, READY View Application. Image analysis software.","Mfg Lot or Serial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m 290 OUS)","GE Healthcare has become aware that when analyzing fMRI images using the READY View application software, incorrect fMRI activation maps may be computed and displayed.",3/27/2012,"03/27/2012",9/25/2013,"09/25/2013"
"Devices",66112,"Ongoing","Edwards Lifesciences, LLC","Draper","UT","US","Voluntary: Firm Initiated","Letter","Nationwide Distribution.","Z-0134-2014","Class II","Edwards Lifesciences Fem-Flex Femoral Arterial Cannula with Duraflo Coating, DIITFA02225, Sterile, RX only For Single Use Only, Product Usage: Edwards Lifesciences femoral access cannulae are intended for use in situations which require rapid femoral venous and arterial access for short-term (< 6 hours) cardiopulmonary bypass. Vessel access (venous or arterial) is left to the discretion of the physician. Femoral access cannulae may be used in pediatric populations or adult populations based on flow rate requirements and individual patient anatomy. Please consult labeling to determine pressure drop related to flow rates. Extracorporeal circuit components with a Duraflo coating are intended for use in cardiopulmonary surgery when a heparin coated blood path is desired.","Lot number 59388992 expiry 1/1/16",".","80 units","Edwards Lifesciences is recalling two lots of Duraflo Cannulas due to reported complaints involving cracks in the t-connector of the devices which were confirmed during product evaluation.",8/26/2013,"08/26/2013",11/13/2013,"11/13/2013"
"Devices",66112,"Ongoing","Edwards Lifesciences, LLC","Draper","UT","US","Voluntary: Firm Initiated","Letter","Nationwide Distribution.","Z-0135-2014","Class II","Edwards Lifesciences Dispersion Aortic Perfusion Cannula with Duraflo Coating, Sterile, RX only For Single Use Only, Product Usage: Aortic perfusion cannulae are intended for perfusion of the ascending aorta during short-term (< 6 hours) cardiopulmonary bypass procedures. Aortic cannulae in sizes 6Fr to 18Fr can be used in pediatric patient populations. Extracorporeal circuit components with a Duraflo coating are intended for use in cardiopulmonary surgery when a heparin coated blood path is desired. ","Lot number 59261626 expiry 06/01/15",".","140 units","Edwards Lifesciences is recalling two lots of Duraflo Cannulas due to reported complaints involving cracks in the t-connector of the devices which were confirmed during product evaluation.",8/26/2013,"08/26/2013",11/13/2013,"11/13/2013"
"Food",66113,"Terminated","New Dream Team","Honolulu","HI","US","Voluntary: Firm Initiated","E-Mail","OR. CO. TX NY, NV","F-1883-2013","Class III","Fresh Basil (Sweet Hawaiian and Thai) New Dream Team Inc. HI","no codes",,"6504 lbs of sweet basil (Hawaiian); 810 lbs of thai basil","State of HI issued Cease and Desist Order to grower of basil for positive sample results for pesticides not allowed on basil.",8/26/2013,"08/26/2013",9/25/2013,"09/25/2013"
"Biologics",66114,"Terminated","OneBlood, Inc.","Orlando","FL","US","Voluntary: Firm Initiated","Letter","Florida","B-2573-13","Class II","Red Blood Cells Leukocytes Reduced","W038113113780; W038113030324; W038112382541; W038112214833; W038112185233; ",,"5","Blood products collected from a therapeutic donor with polycythemia, were distributed. ",6/15/2013,"06/15/2013",11/27/2013,"11/27/2013"
"Biologics",66115,"Terminated","Atlanta Blood Services","MArietta","GA","US","Voluntary: Firm Initiated","FAX","Georgia","B-0002-14","Class II","Platelets Pheresis Leukocytes Reduced","W365513000384; ",".","1","Blood product, labeled as leukoreduced without the assurance that it met the criteria for a leukoreduced product, was distributed. ",6/26/2013,"06/26/2013",12/11/2013,"12/11/2013"
"Drugs",66117,"Ongoing","Dr. Reddy's Laboratories, Inc.","Bridgewater","NJ","US","Voluntary: Firm Initiated","Letter","Nationwide (& Puerto Rico)","D-1042-2013","Class II","IBU (TM) IBUPROFEN Tablets, USP, 800 mg, 500 -count bottle,(NDC 55111-684-05) Rx only, Distributed by Dr. Reddy's Laboratories, Inc., Bridgewater, NJ 08807 USA.","Lot # L300192; Exp. 05/2017",,"18852 bottles","Labeling: Incorrect or missing lot and/or exp date- This product is being recalled due to an incorrect expiration date of 05/2017. The correct expiration date is 10/2016.",8/29/2013,"08/29/2013",9/25/2013,"09/25/2013"
"Food",66118,"Ongoing","Ann's House of Nuts, Inc","Robersonville","NC","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","AZ, CA, CO, FL, GA, IL, KY, MN, MO, MS, NC, NH, NY, PA, TX, VA and WA.","F-1858-2013","Class II","Daily Chef, Tropical Fruit & Nut Blend, 44oz plastic bags, Distributed by SAMs West, Inc., Bentonville, AR 72716.","UPC: 0 78742 00844 8",,"1706 pallets (264 bags per pallet)","Undeclared ingredient; Yellow #5 & #6.",8/22/2013,"08/22/2013",9/4/2013,"09/04/2013"
"Devices",66120,"Ongoing","Baxter Healthcare Corp.","Deerfield","IL","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution-USA including Puerto Rico and Canada.","Z-0197-2014","Class II","SIGMA SPECTRUM Infusion Pump with Master Drug Library. Intended to be used for the controlled administration of intravenous fluids.","Product Code: 35700BAX, 35700ABB Serial Numbers: All ",".","273,835 units","Baxter Healthcare Corporation issued an Urgent Device Correction for the SIGMA SPECTRUM Infusion Pump with Master Drug Drug Library due to reports of upstream occlusion alarms and air-in-line alarms occurring during infusions.",6/10/2013,"06/10/2013",11/20/2013,"11/20/2013"
"Devices",66121,"Ongoing","Varian Medical Systems, Inc.","Charlottesville","VA","US","Voluntary: Firm Initiated","Letter","Worldwide distribution: US (nationwide) distribution in CA and in the country of India.","Z-0065-2014","Class II","VARISOURCE Breast Template System for high-dose rate Brachytherapy. ***INSTRUCTIONS FOR USE*** Breast Bridge & Template System AL13011000 ***Manufacturer: Varian Medical Systems, Inc., 3100 Hansen Way, Palo Alto, CA 94304 USA","Lots #6078184-1, #6078184-2, #6078184-4",".","3 sets","The recall was initiated after Varian Medical became aware the Lexan templates of the Breast Bridge Template System could become bent and turn opaque after steam sterilization. ",8/9/2013,"08/09/2013",10/30/2013,"10/30/2013"
"Devices",66123,"Ongoing","Carefusion 2200 Inc","Vernon Hills","IL","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution-USA (nationwide) including the states of AL, AR, AZ, CA, CO, CT, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, MI, MN, MO, MD, MT, NC, NE, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, TN, TX, UT, VA, WA, WI, and WV and Puerto Rico, and the country of Iceland.","Z-2193-2013","Class II","*** 1) Cat. 4341B; Qty. 10; Thoracentesis Tray; With Catheter; Sterile; CareFusion; 1500 Waukegan Road; McGaw Park, IL 60085 USA; *** 2) Cat. 4341BSDF; Qty. 10; Safe-T Thoracentesis Tray; With Catheter and Sharps Injury Protection; Drug Free; CareFusion; 1500 Waukegan Road; McGaw Park, IL 60085 USA. Indicated for specimen retrieval and therapeutic drainage of the pleural cavity.","*** 1) Product Code: 4341B; Lots: 554361 (Expires 11/30/15); 550463 (Expires 11/30/15); 548675 (Expires 11/30/15); 545891 (Expires 10/31/15); 544746 (Expires 10/31/15); 543978 (Expires 10/31/15); 542297 (Expires 10/31/15); 541063 (Expires 10/31/15); 539859 (Expires 10/31/15); 539470 (Expires 10/31/15); 537723 (Expires 9/30/15); 536497 (Expires 9/30/15); 535600 (Expires 9/30/15); 534616 (Expires 9/30/15); 532917 (Expires 8/31/15); 531869 (Expires 8/31/15); 530729 (Expires 8/31/15); 528789 (Expires 8/31/15); 526724 (Expires 8/31/15); 525767 (Expires 8/31/15); 523275 (Expires 8/31/15); 522256 (Expires 8/31/15); 517247 (Expires 7/31/15); 514103 (Expires 7/31/15); 512953 (Expires 7/31/15); 509413 (Expires 5/31/15); 508928 (Expires 5/31/15); 505191 (Expires 5/31/15); 504328 (Expires 4/30/15); 499957 (Expires 4/30/15); 498168 (Expires 4/30/15); 495057 (Expires 3/31/15), 492933 (Expires 3/31/15); 487660 (Expires 2/28/15); 486920 (Expires 2/28/15); 483377 (Expires 11/30/14); 481000 (Expires 11/30/14); 478361 (Expires 11/30/14); 476883 (Expires 11/30/14); 474403 (Expires 10/31/14); 471330 (Expires 10/31/14); 469597 (Expires 10/31/14); 469561 (Expires 10/31/14); 467093 (Expires 10/31/14); 464366 (Expires 10/31/14); 463156 (Expires 8/31/14); 461311 (Expires 8/31/14); 458579 (Expires 8/31/14); 456606 (Expires 8/31/14); 453734 (Expires 8/31/14); 450541 (Expires 8/31/14); 450540 (Expires 8/31/14); 446817 (Expires 8/31/14); 444048 (Expires 8/31/14); 440805 (Expires 8/31/14); 439236 (Expires 8/31/14); 436820 (Expires 8/31/14) ;433808 (Expires 7/31/14); 429003 (Expires 7/31/14); 427075 (Expires 7/31/14); 424115 (Expires 7/31/14); 420673 (Expires 6/30/14); 419197 (Expires 6/30/14); 417436 (Expires 6/30/14); 413285 (Expires 6/30/14); 411301 (Expires 6/30/14); 408552 (Expires 7/31/14); 405227 (Expires 6/30/14); 403653 (Expires 6/30/14); 400855 (Expires 6/30/14); 399197 (Expires 6/30/14); 389066 (Expires 5/31/14); 387167 (Expires 5/31/14); 382554 (Expires 5/31/14); 380046 (Expires 4/30/14); 377477 (Expires 4/30/14); 375047 (Expires",".","*** 1) 174,580 units; *** 2) 23,330 units","Catheters included in Thoracentesis Tray and Safe-T Thoracentesis Tray - Drug Free may occlude, preventing drainage of excessive fluid from the pleural cavity leading to a potential delay in the medical procedure and potentially serious patient complications.",8/28/2013,"08/28/2013",9/18/2013,"09/18/2013"
"Drugs",66124,"Ongoing","Pfizer Us Pharmaceutical Group","New York","NY","US","Voluntary: Firm Initiated","Letter","US Nationwide","D-014-2014","Class II","Aldactone (spironolactone) tablets, USP, 100 mg, 100-count bottles, Rx only, Distributed by G.D. Searle, Division of Pfizer Inc, NY, NY 10017, NDC 0025-1031-31","V121573, Exp 05/17",,"31 bottles","Marketed without an Approved NDA/ANDA: This recall is being initiated because of changes to the dissolution profile in distributed lots resulting from a manufacturing site change. There is currently no approved application supporting the alternate manufacturing site. ",9/4/2013,"09/04/2013",11/27/2013,"11/27/2013"
"Food",66125,"Ongoing","Tampa Maid Foods, Inc.","Lakeland","FL","US","Voluntary: Firm Initiated","E-Mail","Product was distributed to the following states: Virginia and Tennessee","F-1908-2013","Class I","Frozen, 4/3 lb unlabeled bags contained in a master carton box labeled in part: ''Portico Brand 4/3 lb 170585 Breaded Scallops***Net Wt 12 lb (5.44 kg)***Ingredients:Scallops, Bleached Wheat Flour, Water, Modified Corn Starch, Sugar, Yellow Corn Flour, Salt, Textured Soy Flour, Yeast, Dried Whole Eggs, Sodium Tripolyphosphate, Partially Hydrogenized Soybean Oil, Xanthan Gum, Sodium Hexametaphosphate. Contains: Wheat, Soy, Egg.''","322461L (01283)",,"142 cases","Incorrect Ingredient Labeling",8/21/2013,"08/21/2013",9/25/2013,"09/25/2013"
"Devices",66126,"Completed","GE Healthcare, LLC","Waukesha","WI","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution - USA (nationwide) including the states of : AL AZ, CA, CO, CT, FL, GA, IL, IN, MD,MI, MO, NJ, NY, NC, OK, PA, TX and WI., and the countries of : AUSTRIA, BELGIUM, CANADA, FINLAND, FRANCE, GERMANY, GREAT BRITAIN, IRAQ, JAPAN, LEBANON, NORWAY, PORTUGAL, SPAIN, SWEDEN and TAIWAN.","Z-2257-2013","Class II","GE Healthcare, Seno Advantage, 5183685, 5183685-2, 5183685-3, 5183685-4, 5183685-5, 5183685-6, 5183685-7, 5183685-8, 5183685-9, 5342425, 5342425-2, 5342425-3, 5342425-4, 5342425-5. Seno Advantage is a medical image review station that allows easy selection, processing, filming and media interchange of multi-modality images from a variety of diagnosis imaging systems. When interpreted by a trained physician, mammographic images displayed on the high-resolution monitors may be used as an element for diagnosis. Furthermore filmed images from all modalities may also be used as an element for diagnosis.","Seno Advantage Workstations with RIS CCOW integration: Patient mismatch while receiving images - FMI 12187 Serial # 00000179275GE3 00000136608GE7 00000136609GE5 00000123803GE9 00000206492GE1 00000179274GE6 00000179273GE8 00000179272GE0 00000177331GE6 00000128528GE7 00000132314GE6 00000106422GE9 00000188371GE9 00000179281GE1 00000179282GE9 00000106426GE0 00000106427GE8 00000250274GE8 00000142837GE4 00000142836GE6 000000010001GS 00000114907GE9 00000158810GE2 00000084251GE8 00000112122GE7 00000123807GE0 000000310001GS 000000010008GS 000000010007GS 00000106420GE3 00000114906GE1 00000250277GE1 00000165231GE2 00000136610GE3 00000114088GE8 00000114089GE6 00000112926GE1 00000206490GE5 00000154938GE5 00000190211HP3 00000174027GE3 00000174026GE5 00000190278HP2 000000010004GS 00000164500GE1 00000158809GE4 00000158410GE1 00000165228GE8 00000165229GE6 00000123804GE7 00000166277GE4 00000114091GE2 00000106425GE2 00000106424GE5 00000179280GE3 00000200442GE2 00000250278GE9 00000126082GE7 00000206491GE3 00000164502GE7 00000164503GE5 000000510001GS 00000253622GE5 00000128529GE5 00000126080GE1 00000195402GE3 00000195403GE1 00000218675GE7 00000218674GE0 00000220618GE3 000000010011GS 00000190212HP1 00000220619GE1 000003510001GS 00000117141GE2 00000142832GE5 00000200440GE6 000003310002GS 00000022062GE9 000003310001GS 00000250290GE4 00000295750GE4 00000295751GE2 00000250276GE3 00000295753GE8 00000295752GE0 00000158812GE8 00000166279GE0 000000610001GS 00000075247GE7 00000106423GE7 00000080399GE9 000000610005GS 00000170113GE2 00000L02687311 000000ANT26269 000000G8087001 000000ANT23044 000000ANT25613 000000C7177002 00000193277GE1 00000149802GE1 00000149801GE3 00000165230GE4 000003510003GS 000000310002GS 000000310003GS 000004410002GS 000000610002GS 00000126078GE5 00000126079GE3 000000210002GS 00000164501GE9 00000117137GE0 00000119932GE2 00000142838GE2 000000Q7274004 000000M9335002 000000Q7274002 000000010005GS 000000N",,"179","GE Healthcare has recently become aware that patient mismatch without a warning message could occur on Seno Advantage (SA) workstations under certain circumstances. This issue may impact patient safety.",9/20/2012,"09/20/2012",9/25/2013,"09/25/2013"
"Biologics",66127,"Terminated","Mississippi Blood Services Inc.","Flowood","MS","US","Voluntary: Firm Initiated","FAX","Mississippi; Switzerland","B-2575-13","Class III","Blood and Blood Products for Reprocessing","W069113123942; W069112129934; ",,"2","Blood products, collected from donors whose suitability to donate was not adequately determined, were distributed.",7/26/2013,"07/26/2013",11/27/2013,"11/27/2013"
"Biologics",66127,"Terminated","Mississippi Blood Services Inc.","Flowood","MS","US","Voluntary: Firm Initiated","FAX","Mississippi; Switzerland","B-2574-13","Class II","Red Blood Cells Leukocytes Reduced","W069113123942; W069112129934; ",,"2","Blood products, collected from donors whose suitability to donate was not adequately determined, were distributed.",7/26/2013,"07/26/2013",11/27/2013,"11/27/2013"
"Devices",66128,"Ongoing","H & H Associates","Ordinary","VA","US","Voluntary: Firm Initiated","Letter","Nationwide distribution","Z-0006-2014","Class I","H&H Emergency Cricothyrotomy Kit (Part No. HHECT01/ HHECTK01, NSN 6515-01-573-0692), vacuum sealed and packaged in a 5 mil poly bags, labeled in part ***H & H Associates, Inc. CAGE 1NNH6 www.gohandh.com Ordinary, VA 23131 (800) 326-5708***. The product is used to maintain fracture alignment.","Lots\EXP Dates: CKBD033, CKBE033 August 2015 CKBD034, CKBF034, CKBG034 August 2015 CKBP045 November 2015 CKBP047, CKBQ047 November 2015 CKBR060 February 2016 CKBT065 April 2016 CKBV070, CKBW070, CKBX070 May 2016 CKBX071 May 2016 CKBX076 June 2016 CKBX078 July 2016 CKBX079, CKBY079 July 2016 CKBY080, CKBZ080, CKCA080 July 2016. ",,"6,619 kits","Medical device tubing used for endotracheal airway application may become weakened and rendered ineffective.",8/27/2013,"08/27/2013",10/9/2013,"10/09/2013"
"Food",66129,"Ongoing","American Importing Co, Inc","Minneapolis","MN","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","CA, CO, IN, IA, KS, OR, UT, VA, WA.","F-0082-2014","Class II","Amport Foods Chocolate Raisins. Net Wt. 12 oz (340g). UPC 71725-71190. Allergy Information: This product is produced on equipment shared with peanuts and tree nut products.","Lot 078X344 Exp 12-19-13",,"3024 cases (8 units/case)","It was discovered that a package of Milk Chocolate Peanuts was erroneously labeled as Milk Chocolate Raisins.",8/21/2013,"08/21/2013",11/6/2013,"11/06/2013"
"Food",66129,"Ongoing","American Importing Co, Inc","Minneapolis","MN","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","CA, CO, IN, IA, KS, OR, UT, VA, WA.","F-0082-2014","Class II","Amport Foods Chocolate Raisins. Net Wt. 12 oz (340g). UPC 71725-71190. Allergy Information: This product is produced on equipment shared with peanuts and tree nut products.","Lot 078X344 Exp 12-19-13",,"3024 cases (8 units/case)","It was discovered that a package of Milk Chocolate Peanuts was erroneously labeled as Milk Chocolate Raisins.",8/26/2013,"08/26/2013",11/6/2013,"11/06/2013"
"Food",66130,"Completed","Stonyfield Farm","Londonderry","NH","US","Voluntary: Firm Initiated","Telephone","CT, NY,MA","F-1877-2013","Class II","Stonyfield Organic O Soy Yogurt Strawberry , 6 oz.cup, Refrigerated USPC code: 05215900603","Use By:11/08/2013",".","140 cases (1680 cups)","Coliform level exceeds product specification",8/28/2013,"08/28/2013",9/18/2013,"09/18/2013"
"Food",66131,"Ongoing","Green Mountain Coffee Roasters","Waterbury","VT","US","Voluntary: Firm Initiated","Letter","IL, CA, OR, WA, UT","F-1966-2013","Class III","Tully's House Blend Decaffeinated K-Cup Packs (12-ct retail box) Product Code: 8803; UPC: 099555088038","Best By: 27 MAR 2014, 28 MAR 2014 Lot Numbers: NA PL055 3181, NA PL055 3182 ",,"28,182 retail boxes","Individual regular (caffeinated) K-Cup packs were packaged inside multiunit Decaffeinated retail boxes.",9/6/2013,"09/06/2013",10/9/2013,"10/09/2013"
"Food",66131,"Ongoing","Green Mountain Coffee Roasters","Waterbury","VT","US","Voluntary: Firm Initiated","Letter","IL, CA, OR, WA, UT","F-1965-2013","Class III","Tullys House Blend Coffee 12-ct K-Cup packs; Product Code: 8802 (Case of 6 - 12 count retail boxes) UPC: 10099555088028","Best By: 27 MAR 2014, 28 MAR 2014 Lot Numbers: NA 8802 PL055 3181, NA 8802 PL055 3182 ",,"4,697 master cases (6 retail boxes per case)","Individual regular (caffeinated) K-Cup packs were packaged inside multiunit Decaffeinated retail boxes.",9/6/2013,"09/06/2013",10/9/2013,"10/09/2013"
"Devices",66132,"Ongoing","Siemens Healthcare Diagnostics, Inc","East Walpole","MA","US","Voluntary: Firm Initiated","Letter","Nationwide Distribution including MD, PA, and CT.","Z-0173-2014","Class III","ADVIA Centaur Intact PTH Calibrator (6 pack); Catalog Number: SMN 10492387 For in vitro diagnostic use in calibrating Intact PTH assays on the ADVIA Centaur Systems. ","Kit Lot: 14136A16 04 Mar 2014",".","595 kits total (5 kits with packaging error)","PTH Calibrator packaged with only high calibrator. ",8/16/2013,"08/16/2013",11/13/2013,"11/13/2013"
"Devices",66133,"Ongoing","Lumenis, Inc.","Salt Lake City","UT","US","Voluntary: Firm Initiated","Letter","Distributed in the states of NJ, PA, and IL.","Z-2191-2013","Class II","Vision One Laser System Model GA-0025020, Serial No: 10050, 10051, 10053. Intended for use in the treatment of ocular pathology.","Model: GA-0025020",".","3 units","Lumenis has initiated a recall on certain models of Vision One System due to a potential for unintended laser exposure to the user.",8/19/2013,"08/19/2013",9/18/2013,"09/18/2013"
"Drugs",66134,"Ongoing","Hospira Inc.","Lake Forest","IL","US","Voluntary: Firm Initiated","Letter","Nationwide","D-932-2013","Class II","Propofol Injectable Emulsion, 1%, 200 mg/20 mL (10 mg/mL), packaged in 5 Units x 20 mL Single patient infusion vials per carton, Rx only, Hospira, Inc. Lake Forest, IL 60045, NDC 0409-4699-30","Lot #: 24-461-DJ*, Exp 12/14; 26-543-DJ*, Exp 02/15; 27-555-DJ*, 27-559-DJ*, Exp 03/15; *lot number may be followed by 01",".","283,150 vials","Presence of Particulate Matter: Visible particulate embedded in the glass vial was observed and confirmed in a sample bottle during retain sample inspection. ",8/14/2013,"08/14/2013",9/18/2013,"09/18/2013"
"Biologics",66136,"Ongoing","Ortho Clinical Diagnostics Inc","Raritan","NJ","US","Voluntary: Firm Initiated","Telephone","Nationwide","B-2518-13","Class III","Ortho Verseia Pipetter (VERSEIA)","All VERSEIA Pipetters with software Versions 2.2, 2.3, 3.0 and 3.1; (Product Code: 5561701) There is no expiration date for these serialized products.",,"4","ORTHO VERSEIA Pipetter software, with a defect or glitch that in certain circumstances during plate processing, has the potential for false negative results.",8/21/2013,"08/21/2013",11/6/2013,"11/06/2013"
"Devices",66137,"Ongoing","Stryker Medical Division of Stryker Corporation","Portage","MI","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution - USA (nationwide) and Internationally to Canada; Japan, South America, Latin America and China.","Z-0363-2014","Class II","Model FL14E Rose BedsThe Rose Bed is an AC-powered adjustable long-term care bed intended for medical purposes that consists of a bed with a built-in motor and controls that can be operated to adjust the height and surface contour of the bed. The device includes movable and latchable siderails","Model FL14E B01008 B05307 B08323 B11351 B14383 B17357 B20142 B23142 B01010 B05308 B08324 B11352 B14384 B17358 B20143 B23143 B01022 B05309 B08325 B11353 B14385 B17358 B20144 B23144 B01045 B05310 B08326 B11354 B14386 B17359 B20145 B23145 B01045 B05311 B08327 B11355 B14387 B17359 B20146 B23146 B01323 B05312 B08328 B11356 B14388 B17360 B20147 B23147 B01356 B05313 B08329 B11357 B14389 B17360 B20148 B23148 B01392 B05314 B08330 B11358 B14390 B17361 B20149 B23149 B01433 B05315 B08331 B11359 B14391 B17361 B20150 B23150 B01434 B05316 B08332 B11360 B14392 B17362 B20151 B23151 B01465 B05317 B08333 B11361 B14393 B17362 B20152 B23152 B01466 B05318 B08334 B11362 B14394 B17363 B20153 B23153 B01467 B05319 B08335 B11363 B14395 B17363 B20154 B23154 B01470 B05320 B08336 B11364 B14396 B17364 B20155 B23155 B01542 B05321 B08337 B11365 B14397 B17364 B20156 B23156 B01597 B05322 B08338 B11366 B14398 B17365 B20157 B23157 B01598 B05323 B08339 B11367 B14399 B17365 B20158 B23158 B01602 B05324 B08340 B11368 B14400 B17366 B20159 B23159 B01729 B05325 B08341 B11369 B14401 B17366 B20160 B23160 B01779 B05326 B08342 B11370 B14402 B17367 B20161 B23161 B01780 B05327 B08343 B11371 B14403 B17367 B20162 B23162 B01781 B05328 B08344 B11372 B14404 B17368 B20163 B23163 B01995 B05329 B08345 B11373 B14405 B17368 B20164 B23164 B01996 B05330 B08346 B11374 B14406 B17369 B20165 B23165 B01997 B05331 B08347 B11375 B14407 B17369 B20166 B23166 B01998 B05332 B08348 B11376 B14408 B17370 B20167 B23167 B01999 B05333 B08349 B11377 B14409 B17370 B20168 B23168 B02000 B05334 B08350 B11378 B14410 B17371 B20169 B23169 B02001 B05335 B08351 B11379 B14411 B17371 B20170 B23170 B02002 B05336 B08352 B11380 B14412 B17372 B20171 B23171 B02013 B05337 B08353 B11381 B14413 B17372 B20172 B23172 B02014 B05338 B08354 B11382 B14414 B17373 B20173 B23173 B02015 B05339 B08355 B11383 B14415 B17373 B20174 B23174 B02016 B05340 B08356 B11384 B14416 B17374 B20175 B23175 B02017 B05341 B08357 B11385 B14417 B17374 B20176 B23176 B02018 B05342 B08358 B11386 B14418 B17375 B20177 B23177 B02019 B05343 B08"," B05878 B08897 B11922 B14950 B17887 B20713 B23713 B02853 B05879 B08898 B11923 B14951 B17888 B20714 B23714 B02854 B05880 B08899 B11924 B14952 B17889 B20715 B23715 B02855 B05881 B08900 B11925 B14953 B17890 B20716 B23716 B02856 B05882 B08901 B11926 B14954 B17891 B20717 B23717 B02857 B05883 B08902 B11927 B14955 B17892 B20718 B23718 B02858 B05884 B08903 B11928 B14956 B17893 B20719 B23719 B02859 B05885 B08904 B11930 B14957 B17894 B20720 B23720 B02860 B05886 B08905 B11931 B14958 B17895 B20721 B23721 B02861 B05887 B08906 B11932 B14959 B17896 B20722 B23722 B02862 B05888 B08907 B11933 B14960 B17897 B20723 B23723 B02863 B05889 B08908 B11934 B14961 B17898 B20724 B23724 B02864 B05890 B08909 B11935 B14962 B17899 B20725 B23725 B02865 B05891 B08910 B11936 B14963 B17900 B20726 B23726 B02866 B05892 B08911 B11937 B14964 B17901 B20727 B23727 B02867 B05893 B08912 B11938 B14965 B17902 B20728 B23728 B02868 B05894 B08913 B11939 B14966 B17903 B20729 B23729 B02869 B05895 B08914 B11940 B14967 B17904 B20730 B23730 B02870 B05896 B08915 B11941 B14968 B17905 B20731 B23731 B02871 B05897 B08916 B11942 B14969 B17906 B20732 B23732 B02872 B05898 B08917 B11943 B14970 B17907 B20733 B23733 B02873 B05899 B08918 B11944 B14971 B17908 B20734 B23734 B02874 B05900 B08919 B11945 B14972 B17909 B20735 B23735 B02875 B05901 B08920 B11946 B14973 B17910 B20736 B23736 B02876 B05902 B08921 B11947 B14974 B17911 B20737 B23737 B02877 B05903 B08922 B11948 B14975 B17912 B20738 B23738 B02878 B05904 B08923 B11949 B14976 B17913 B20739 B23739 B02879 B05905 B08924 B11950 B14977 B17914 B20740 B23740 B02880 B05906 B08925 B11951 B14978 B17915 B20741 B23741 B02881 B05907 B08926 B11952 B14979 B17916 B20742 B23742 B02882 B05908 B08927 B11953 B14980 B17917 B20743 B23743 B02883 B05909 B08928 B11954 B14981 B17918 B20744 B23744 B02884 B05910 B08929 B11955 B14982 B17919 B20745 B23745 B02885 B05911 B08930 B11956 B14983 B17920 B20746 B23746 B02886 B05912 B08931 B11957 B14984 B17921 B20747 B23747 B02887 B05913 B08932 B11958 B14985 B17922 B20748 B23748 B02888 B05914 B08933 B11959 B14986 ","4126 units USA; 20449 inits Internationally","It was reported that the siderail may appear latched when it is not, due to lack of proper preventive maintenance. This might result in bruises and/or lacerations to a patient who is leaning against the siderails if the siderail releases. Additionally, the siderail may not effectively constrain a patient to prevent them from rolling or falling off the bed. ",10/23/2013,"10/23/2013",11/27/2013,"11/27/2013"
"Devices",66138,"Ongoing","Steris Corporation","Mentor","OH","US","Voluntary: Firm Initiated","Letter","Nationwide distribution: USA including the states of Alabama, Arkansas, Florida, Georgia, Illinois, Indiana, Kansas, Kentucky, Louisiana, Maryland, Massachusetts, Michigan, Minnesota, Missouri, Nebraska, New Jersey, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Texas, Virginia, Washington and Wisconsin.","Z-0141-2014","Class II","Harmony Equipment Management System, Model #603X/80XX, STERIS Corporation, Mentor, OH Harmony Equipment Management Systems (EMS) are used in hospital facilities to provide ready access to medical gasses, electrical power and audio/visual data services, in addition to managing surgical support equipment such as endoscopic equipment, cautery devices and insufflators.","Serial numbers 0422503114 - 0426604096",".","127 units","Drger Medical GmbH has notified STERIS of the potential for a break in the drive screw contained in the motorized ceiling supply unit, a component of the Harmony EMS system. The ceiling supply unit controls the motorized adjustment of the height and rotation of the supply column. Should a break occur in the drive screw, there is potential for the adjustable arm to drop down, causing the EMS system to lower unexpectedly.",8/15/2013,"08/15/2013",11/13/2013,"11/13/2013"
"Food",66140,"Ongoing","Blythedale Farm Inc.","Corinth","VT","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","VT, NH, CT, RI, ME, NY, MA, DC, IL, CA","F-1955-2013","Class II","Blythedale Farm Vermont Brie, 7 oz. wrapped disc in plastic cup UPC Code: 762713669010","Best Buy or Sell By date prior to October 19",".","11,678 units","Inadequate pasteurization",8/29/2013,"08/29/2013",10/2/2013,"10/02/2013"
"Food",66140,"Ongoing","Blythedale Farm Inc.","Corinth","VT","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","VT, NH, CT, RI, ME, NY, MA, DC, IL, CA","F-1956-2013","Class II","Blythedale Farm Farmstead Brie, 1 lb white wrapped disc UPC Code: ","Best Buy or Sell By date prior to October 19",".","143 units","Inadequate pasteurization",8/29/2013,"08/29/2013",10/2/2013,"10/02/2013"
"Food",66140,"Ongoing","Blythedale Farm Inc.","Corinth","VT","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","VT, NH, CT, RI, ME, NY, MA, DC, IL, CA","F-1957-2013","Class II","Blythedale Farm Camembert Vermont, 7 oz wrapped disc in plastic cup UPC Code: 762713669027","Best Buy or Sell By date prior to October 19",".","9, 078 units","Inadequate pasteurization",8/29/2013,"08/29/2013",10/2/2013,"10/02/2013"
"Biologics",66141,"Terminated","Inland Northwest Blood Center","Spokane","WA","US","Voluntary: Firm Initiated","Letter","Switzerland; Washington","B-2577-13","Class II","Blood and Blood Products for Reprocessing","W068513001326; ",,"1","Blood products, collected from a donor considered to be at increased risk for Creutzfeldt-Jakob Disease (CJD), were distributed. ",6/6/2013,"06/06/2013",11/27/2013,"11/27/2013"
"Biologics",66141,"Terminated","Inland Northwest Blood Center","Spokane","WA","US","Voluntary: Firm Initiated","Letter","Switzerland; Washington","B-2576-13","Class II","Cryoprecipitated AHF","W068513001326; ",,"1","Blood products, collected from a donor considered to be at increased risk for Creutzfeldt-Jakob Disease (CJD), were distributed. ",6/6/2013,"06/06/2013",11/27/2013,"11/27/2013"
"Food",66142,"Ongoing","Premier Foods, LLC","Santa Fe Springs","CA","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","MS and NJ","F-1886-2013","Class I","40-Clove Garlic Chicken Braising Base, 24.5oz, 12 jars/case","Lot #: 12713-10PF1, 12713-10PF2",,"3000 units","Premier Foods is recalling Williams-Sonoma flavored sauces due to undeclared milk and wheat allergens.",8/28/2013,"08/28/2013",9/25/2013,"09/25/2013"
"Food",66142,"Ongoing","Premier Foods, LLC","Santa Fe Springs","CA","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","MS and NJ","F-1885-2013","Class I","Meyer Lemon Braising Base, 1lb. 8.5 oz, 12 jars/case","Lot #: 12213-2PF1, 12213-2PF2, 12213-2PF3",,"3000 units","Premier Foods is recalling Williams-Sonoma flavored sauces due to undeclared milk, soy (hydrolyzed soy protein), and wheat allergens.",8/28/2013,"08/28/2013",9/25/2013,"09/25/2013"
"Food",66142,"Ongoing","Premier Foods, LLC","Santa Fe Springs","CA","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","MS and NJ","F-1891-2013","Class II","Artichoke Pecorino Sauce, 16 fl. oz., 12 jars/case","Lot#: 01813-16PF1, 01813-16PF2, 01813-16PF3, 01813-16PF4",,"5880 units","Premier Foods is recalling Williams-Sonoma flavored sauces due to undeclared soy allergens (hydrolyzed soy protein).",8/28/2013,"08/28/2013",9/25/2013,"09/25/2013"
"Food",66142,"Ongoing","Premier Foods, LLC","Santa Fe Springs","CA","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","MS and NJ","F-1890-2013","Class I","Tagine Sauce, 16 fl. oz., 12 jars/case","Lot #: 08413-14PF1, 08413-14PF2",,"3000 units","Premier Foods is recalling Williams-Sonoma flavored sauces due to undeclared milk and wheat allergens.",8/28/2013,"08/28/2013",9/25/2013,"09/25/2013"
"Devices",66143,"Ongoing","Camlog Usa","Indianapolis","IN","US","Voluntary: Firm Initiated",,"USA Distribution in the states of NH, MD, CO, and IL.","Z-2206-2013","Class II","C2244.5008 CONELOG Titanbasis CAD/CAM Conelog Titanium Base CAD/CAM Rx only 5.0GH 0.8 inkl HS Product Usage: Endosseous dental implant abutment CONELOG Abutments are intended to be used to fabricate prosthetic restorations in conjunction with CONELOG implants to support prostheses in the maxillary and/or mandibular arch. ","lot 43377 ",,"3 in USA","Product not cleared for sale/use in the United States.",8/28/2013,"08/28/2013",9/25/2013,"09/25/2013"
"Devices",66143,"Ongoing","Camlog Usa","Indianapolis","IN","US","Voluntary: Firm Initiated",,"USA Distribution in the states of NH, MD, CO, and IL.","Z-2203-2013","Class II","C2244.3808, CONELOG Titanium Base CC 3.8GH0.8 inkl HS Product Usage: Endosseous dental implant abutment CONELOG Abutments are intended to be used to fabricate prosthetic restorations in conjunction with CONELOG implants to support prostheses in the maxillary and/or mandibular arch. ","43746",,"2 in USA","Product not cleared for sale/use in the United States.",8/28/2013,"08/28/2013",9/25/2013,"09/25/2013"
"Devices",66143,"Ongoing","Camlog Usa","Indianapolis","IN","US","Voluntary: Firm Initiated",,"USA Distribution in the states of NH, MD, CO, and IL.","Z-2204-2013","Class II","C2244.3820;, CONELOG Titanium Base CC 3.8GH2.0 inkl HS Product Usage: Endosseous dental implant abutment CONELOG Abutments are intended to be used to fabricate prosthetic restorations in conjunction with CONELOG implants to support prostheses in the maxillary and/or mandibular arch. ","39437",,"1 in USA","Product not cleared for sale/use in the United States.",8/28/2013,"08/28/2013",9/25/2013,"09/25/2013"
"Devices",66143,"Ongoing","Camlog Usa","Indianapolis","IN","US","Voluntary: Firm Initiated",,"USA Distribution in the states of NH, MD, CO, and IL.","Z-2205-2013","Class II","C2244.4308 CONELOG Titanium Base CC 4.3GH2 0.8 inkl HS Product Usage: Endosseous dental implant abutment CONELOG Abutments are intended to be used to fabricate prosthetic restorations in conjunction with CONELOG implants to support prostheses in the maxillary and/or mandibular arch. ","4460 and 44163",,"6 to US customers","Product not cleared for sale/use in the United States.",8/28/2013,"08/28/2013",9/25/2013,"09/25/2013"
"Devices",66144,"Ongoing","Fujinon Inc","Wayne","NJ","US","Voluntary: Firm Initiated","Letter","Worldwide distribution: US (nationwide) including states of: NJ, PA and VA; and country of Canada.","Z-0112-2014","Class II","Fujinon/Fujifilm Ultrasonic Endoscope Intended to provide ultrasonic images of submucosal and peripheral organs of the upper gastrointestinal tract for observation, diagnosis and endoscopic treatment.","Model Number EG-530UT2. Serial Numbers: NU038A018, NU038A019, NU038A022, NU038A027, NU038A028 and NU038A029",,"828 units","RAPIDPoint 400 Series, RAPIDPoint 500, or RAPIDLab 1200 Series blood gas analyzer, users can inadvertently enter a wrong patient ID on the demographics screen, which ultimately could lead to a misidentification of the sample",9/17/2012,"09/17/2012",11/6/2013,"11/06/2013"
"Devices",66144,"Ongoing","Fujinon Inc","Wayne","NJ","US","Voluntary: Firm Initiated","Letter","Worldwide distribution: US (nationwide) including states of: NJ, PA and VA; and country of Canada.","Z-0112-2014","Class II","Fujinon/Fujifilm Ultrasonic Endoscope Intended to provide ultrasonic images of submucosal and peripheral organs of the upper gastrointestinal tract for observation, diagnosis and endoscopic treatment.","Model Number EG-530UT2. Serial Numbers: NU038A018, NU038A019, NU038A022, NU038A027, NU038A028 and NU038A029",,"12 Units","A limited number of endoscopes were shipped to FMSU-ESD with a manufacturing defect which included missing set screws used to more securely attach the Forceps Inlet (biopsy inlet port) to the endoscope.",7/31/2013,"07/31/2013",11/6/2013,"11/06/2013"
"Devices",66145,"Ongoing","DePuy Mitek, Inc., a Johnson & Johnson Co.","Raynham","MA","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Worldwide Distribution - USA (Nationwide) and in the countries of: Australia , Austria , Belgium , Canada , Czech Republic , Denmark , Finland , France, Germany , India, Ireland , Israel, Italy , Latvia , Netherlands , Norway , Nepal, Poland , Portugal , Spain , Sweden , Switzerland , United Kingdom.","Z-0192-2014","Class II"," DePuy Mitek FMS Outflow Tubing with One-Way valve Product Code:284649 Product Usage: The Intermediary Tubing for FMS Fluid Management Systems connects the Inflow Tubing to the arthroscopic sheath during arthroscopic procedures. The Polyvinyl Chloride (PVC) tubing integrates several functional components including: luer locks for attaching the tube to the Inflow tubing and sheath, clamps, and a one-way valve. The FMS Outflow Tubing with One-Way valve is sterile and intended for single use with the FMS Fluid Management Systems in a surgical setting by personnel trained in arthroscopy.","All lot codes",".","29280 units","Pillow valve included in the FMS Duo outflow tubing set and the FMS Solo intermediary tubing set may not perform as intended. may result in backflow of irrigation fluid into the One Day Set which may potentially lead to patient cross-contamination",8/29/2013,"08/29/2013",11/20/2013,"11/20/2013"
"Devices",66145,"Ongoing","DePuy Mitek, Inc., a Johnson & Johnson Co.","Raynham","MA","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Worldwide Distribution - USA (Nationwide) and in the countries of: Australia , Austria , Belgium , Canada , Czech Republic , Denmark , Finland , France, Germany , India, Ireland , Israel, Italy , Latvia , Netherlands , Norway , Nepal, Poland , Portugal , Spain , Sweden , Switzerland , United Kingdom.","Z-0191-2014","Class II","DePuy Mitek FMS Intermediary Tubing with One-Way valve Product Code: 281142 Product Usage: The Intermediary Tubing for FMS Fluid Management Systems connects the Inflow Tubing to the arthroscopic sheath during arthroscopic procedures. The Polyvinyl Chloride (PVC) tubing integrates several functional components including: luer locks for attaching the tube to the Inflow tubing and sheath, clamps, and a one-way valve. The FMS Intermediary Tubing is sterile and intended for single use with the FMS Fluid Management Systems in a surgical setting by personnel trained in arthroscopy .","All lots with a D identifier ",".","368 pk","Pillow valve included in the FMS Duo outflow tubing set and the FMS Solo intermediary tubing set may not perform as intended. may result in backflow of irrigation fluid into the One Day Set which may potentially lead to patient cross-contamination",8/29/2013,"08/29/2013",11/20/2013,"11/20/2013"
"Food",66146,"Ongoing","The Seafood Exchange Of Fla","Raleigh","NC","US","Voluntary: Firm Initiated","E-Mail","TX","F-1870-2013","Class II","H-E-B Jumbo Butterfly Shrimp-10.5 oz Box, 20 units per case","Product marked with ''BEST BY 23APR2014''",".","190 cases delivered to H-E-B warehouses","Cartons of this product have been found to contain coconut shrimp. Coconut is not listed as an ingredient.",8/29/2013,"08/29/2013",9/11/2013,"09/11/2013"
"Devices",66148,"Ongoing","GE Healthcare, LLC","Waukesha","WI","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution - USA (nationwide) including the states of : AL, AZ, AR, CA, CO, CT, FL, GA, ID, IL, IN, IA, KS, KY, LA, MD, MA, MI, MN, MS, MO, NE, NV,NH, NH, NM, NY, NC, OH, OK OR, PA, PR, SC, TN, TX, VA, WA, WV, WI and WY., and the countries of : ARGENTINA, AUSTRALIA, AUSTRIA, BAHRAIN, BANGLADESH, BELGIUM, BOLIVIA, BRAZIL, BULGARIA, CANADA, CHILE, COLOMBIA, COSTA RICA. CROATIA, CZECH REPUBLIC, DENMARK, EGYPT, FINLAND, FRANCE, GERMANY, HONG KONG, HUNGARIA, ICELAND, INDIA, INDONESIA, IRAQ, IRELAND, ISRAEL, ITALY, JAPAN, JORDAN, KOREA, KUWAIT, LEBANON, LITHUANIA, MALAYSIA, MOROCCO, NETHERLAND, NEW ZEALAND, NICARAGUA, NORWAY, OMAN, PAKISTAN, PANAMA, PARAGUAY, PERU, POLAND, PORTUGAL, QATAR, ROMANIA, RUSSIA, SAUDI ARABIA, SINGAPORE, SLOVAKIA, SLOVENIA, SOUTH AFRICA, SPAIN, SWEDEN, SWITZERLAND, SYRIA, THAILAND, TURKEY, UNITED ARAB EMIRATES, UNITED KINGDOM and VENEZUELA.","Z-2256-2013","Class II","GE Healthcare, CARESCAPE Monitor B650. The CARESCAPE Monitor B650 is a multi-parameter patient monitor intended for use in multiple areas and intra-hospital transport within a professional healthcare facility. The CARESCAPE Monitor B650 is intended for use on adult, pediatric, and neonatal patients and on one patient at a time. The CARESCAPE Monitor B650 is indicated for monitoring and recording of, and to generate alarms for, hemodynamic (including EGG, ST segment, arrhythmia detection, ECU diagnostic analysis and measurement, invasive pressure, non-invasive blood pressure, pulse oximetry, cardiac output, temperature and mixed venous oxygen saturation), impedance respiration, airway gases (C02, 02, N20 and anesthetic agents), spirometry, gas exchange, and neurophysiological (including electroencephalography, Entropy, Bispectral Index (HI1S) and neuromuscular transmission) status. The CARESCAPE Monitor B650 can be a stand-alone monitor or interfaced to other devices. It can also be connected to other monitors for remote viewing and to data management software devices via a network. The CARESCAPE Monitor B650 is intended for use under the direct supervision of a licensed healthcare practitioner, or by personnel trained in proper use of the equipment in a professional healthcare facility. The CARESCAPE Monitor B650 is not intended for use during MRI.","Parent SN SEW10233202HA SEW10233203HA SEW10233204HA SEW10233206HA SEW10233209HA SEW10233210HA SEW10243447HA SEW10243449HA SEW10243450HA SEW10243458HA SEW10243476HA SEW10243477HA SEW10243478HA SEW10243479HA SEW10243481HA SEW10243482HA SEW10243484HA SEW10243486HA SEW10243487HA SEW10243489HA SEW10243490HA SEW10243491HA SEW10243492HA SEW10243496HA SEW10243498HA SEW10243499HA SEW10243500HA SEW10243503HA SEW10243504HA SEW10354687HA SEW10354688HA SEW10354694HA SEW10354695HA SEW10354696HA SEW10354697HA SEW10354701HA SEW10354704HA SEW10354706HA SEW10354707HA SEW10354708HA SEW10354709HA SEW10354712HA SEW10354713HA SEW10354717HA SEW10354722HA SEW10354724HA SEW10354728HA SEW10354730HA SEW10354736HA SEW10354738HA SEW10354740HA SEW10354741HA SEW10354746HA SEW10354749HA SEW10354751HA SEW10354752HA SEW10354754HA SEW10354756HA SEW10354757HA SEW10354758HA SEW10354759HA SEW10354760HA SEW10354761HA SEW10354762HA SEW10354763HA SEW10354764HA SEW10354767HA SEW10354768HA SEW10354773HA SEW10354774HA SEW10354775HA SEW10354776HA SEW10354777HA SEW10354778HA SEW10354780HA SEW10354781HA SEW10354783HA SEW10354784HA SEW10385221HA SEW10385223HA SEW10385225HA SEW10385226HA SEW10385227HA SEW10385228HA SEW10385229HA SEW10385230HA SEW10385231HA SEW10385232HA SEW10385234HA SEW10385236HA SEW10385256HA SEW10393672HA SEW10393675HA SEW10393682HA SEW10393747HA SEW10405542HA SEW10405618HA SEW10405648HA SEW10405669HA SEW10405670HA SEW10405673HA SEW10405696HA SEW10446451HA SEW10446466HA SEW10456855HA SEW10467083HA SEW10467133HA SEW10467151HA SEW10467216HA SEW10467289HA SEW10517983HA SEW10528081HA SEW10528111HA SEW11018531HA SEW11018538HA SEW11018545HA SEW11018644HA SEW11018645HA SEW11018646HA SEW11018647HA SEW11018650HA SEW11018651HA SEW11018652HA SEW11018653HA SEW11018702HA SEW11018721HA SEW11018725HA SEW11018729HA SEW11018730HA SEW11018731HA SEW11018732HA SEW11038851HA SEW11038910HA SEW11038918HA SEW11059070HA SEW11059082HA SEW11059083HA SEW11059084HA SEW11059128HA SEW11059129HA SEW11059130HA SEW11059131HA SEW11059132HA SEW11059133HA SEW11059134HA SEW11"," SEW12131756HA SEW12131757HA SEW12131758HA SEW12131759HA SEW12131760HA SEW12131761HA SEW12131762HA SEW12131763HA SEW12131764HA SEW12131765HA SEW12131766HA SEW12131767HA SEW12131768HA SEW12131769HA SEW12131770HA SEW12131771HA SEW12131772HA SEW12131773HA SEW12131774HA SEW12131775HA SEW12131776HA SEW12131777HA SEW12131778HA SEW12131779HA SEW12131780HA SEW12131781HA SEW12131782HA SEW12131787HA SEW12131791HA SEW12131792HA SEW12131793HA SEW12131794HA SEW12131795HA SEW12131796HA SEW12131797HA SEW12131798HA SEW12131799HA SEW12131800HA SEW12131801HA SEW12131802HA SEW12131803HA SEW12131804HA SEW12131805HA SEW12131806HA SEW12131807HA SEW12131808HA SEW12131809HA SEW12131810HA SEW12131812HA SEW12131813HA SEW12131814HA SEW12131815HA SEW12131822HA SEW12131856HA SEW12131859HA SEW12131860HA SEW12131861HA SEW12131862HA SEW12131863HA SEW12131864HA SEW12131866HA SEW12131867HA SEW12131868HA SEW12131869HA SEW12131870HA SEW12131871HA SEW12131872HA SEW12131873HA SEW12131874HA SEW12131875HA SEW12131876HA SEW12131877HA SEW12131878HA SEW12131879HA SEW12131880HA SEW12131881HA SEW12131884HA SEW12131885HA SEW12131886HA SEW12131887HA SEW12141970HA SEW12141971HA SEW12141976HA SEW12141977HA SEW12141978HA SEW12141979HA SEW12141980HA SEW12141994HA SEW12142001HA SEW12142002HA SEW12142003HA SEW12142006HA SEW12142007HA SEW12142008HA SEW12142009HA SEW12142010HA SEW12142012HA SEW12142013HA SEW12142014HA SEW12142015HA SEW12142016HA SEW12142018HA SEW12142020HA SEW12142021HA SEW12142022HA SEW12142023HA SEW12142032HA SEW12142033HA SEW12142034HA SEW12142035HA SEW12142036HA SEW12142038HA SEW12142045HA SEW12142056HA SEW12142057HA SEW12142061HA SEW12142062HA SEW12142063HA SEW12152080HA SEW12152084HA SEW12152085HA SEW12152086HA SEW12152088HA SEW12152089HA SEW12152090HA SEW12152093HA SEW12152094HA SEW12152098HA SEW12152099HA SEW12152100HA SEW12152101HA SEW12152102HA SEW12162380HA SEW12162381HA SEW12162383HA SEW12162384HA SEW12162398HA SEW12162399HA SEW12162400HA SEW12182571HA SEW12182582HA SEW12182583HA SEW12182584HA SEW12182596HA SEW12182601HA SEW12182604HA ","9466 (3261 US, 6205 OUS)","GE Healthcare has recently become aware of a number of potential issues associated with the CARESCAPE Monitor B650. No injuries or illnesses have been reported.",7/12/2012,"07/12/2012",9/25/2013,"09/25/2013"
"Devices",66150,"Ongoing","CareFusion 303, Inc.","San Diego","CA","US","Voluntary: Firm Initiated","Letter","Nationwide Distribution including CA","Z-2279-2013","Class II","SmartSite Low Sorbing Infusion Set, Model#72313E The SmartSite Low Sorbing Infusion Sets are used to administer fluid and medications through a needle or catheter inserted into the patient's artery or vein. The SmartSite Low Sorbing set is comprised of components commonly found on intravascular administration sets and extension sets. It includes a 1.2 micron filter, needleless SmartSite connector, low sorbing tubing segment, pinch clamps, and luer connectors.","Lot Number 13016314",".","600 units","CareFusion is recalling the SmartSite Low Sorbing Infusion Set, Model 72313E, Lot Number 13016314, because of an incorrect filter was assembled on this lot. The correct filter is a 1.2 micron filter (blue color) but a 0.2 micron filter (clear color) may have been added instead.",8/30/2013,"08/30/2013",10/2/2013,"10/02/2013"
"Devices",66151,"Ongoing","CareFusion 303, Inc.","San Diego","CA","US","Voluntary: Firm Initiated","Letter","Class II Recall - United States ***Center Recommended Depth - Consumers/Users**","Z-2285-2013","Class II","SmartSite Low Sorbing Infusion Set, Model# 10015048. Intravascular administration set.","Lot Numbers 13015883 and 13025342.",".","15860 units","CareFusion is recalling the SmartSite Low Sorbing Infusion Set, Model# 10015048, because there is a potential for separation at the tubing sleeve below the drip chamber.",8/30/2013,"08/30/2013",10/2/2013,"10/02/2013"
"Devices",66152,"Ongoing","CareFusion 303, Inc.","San Diego","CA","US","Voluntary: Firm Initiated","Letter","Nationwide Distribution","Z-2281-2013","Class II","CareFusion Gravity Set, Model #44000-07 The CareFusion Gravity Sets are used to administer fluid and medication through a needle or catheter inserted into the patient's artery or vein. The CareFusion Gravity Set is comprised of components commonly found on intravascular administration sets and extension sets. It includes a check valve, injection ports, 4-way stopcock, anti-siphon valve, roller clamp and tubing.","Lot Numbers: 12086930, 12106215, 13016408, 13016834, 13025446, and 13025672.",".","2,850 units","CareFusion is recalling the Gravity Set (Model 44000-07) because of an incorrect expiration date. The affected lot numbers of the Gravity Set are labeled with a 5 year expiration instead of three (3) years.",8/30/2013,"08/30/2013",10/2/2013,"10/02/2013"
"Biologics",66153,"Terminated","University Of Miami Miller School of Medicine Tissue Bank","Miami","FL","US","Voluntary: Firm Initiated","Letter","Indiana","B-0048-14","Class II","Tendon","0086580059",".","1 allograft ","Human tissue allograft, not processed in a manner that prevents the introduction, transmission, or spread of communicable disease, was distributed.",8/23/2013,"08/23/2013",12/11/2013,"12/11/2013"
"Biologics",66154,"Terminated","American Red Cross Blood Services","Saint Louis","MO","US","Voluntary: Firm Initiated","E-Mail","California","B-2572-13","Class III","Blood and Blood Products for Reprocessing","011GC03860; ",,"1 unit","Blood product, collected from a donor whose suitability to donate was not adequately determined, was distributed.",6/21/2013,"06/21/2013",11/27/2013,"11/27/2013"
"Devices",66155,"Ongoing","Cincinnati Sub-Zero Products Inc","Cincinnati","OH","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution - USA including AK, AR, AZ, CA, CO, DC, DE, FL, GA, IA, ID, IL, IN, KY, LA, MA, MD, ME, MI, MN, MT, , NC, ND, NH, NJ, NM, NV, NY, OH, OK, OR, PA, PR, SC, TN, TX, UT, VA, WA, WI & WV. Internationally to ARGENTINA, AUSTRALIA, AZERBAIJAN, BELGIUM, CANADA, CHILE, CHINA, COSTA RICA, CROATIA, GERMANY, HONDURAS, HONG KONG, INDIA, INDONESIA, ISRAEL, KOREA, KUWAIT, MEXICO, NEW ZEALAND, PERU, SAUDI ARABIA, SINGAPORE, SPAIN, TAHITI, THAILAND, THE NETHERLANDS, THE PHILIPPINES, UNITED ARAB EMERITES & UNITED KINGDOM.","Z-2209-2013","Class II","Blanketrol III, Model Number 233, Cincinnati Sub-Zero Products, Inc., 12011 Mosteller Road, Cincinnati, OH 45241 Hyper-Hypothermia device used to lower or to raise a patients temperature and/or maintain a desired patient temperature through conductive heat transfer.","Part number: 86107/06107/6107 (115V), Serial #s: 112-3-02021, 112-3-02102 through 124-3-02783, 074-3-00388, 081-3-00489, 081-3-00493, 082-3-00511, 091-3-00935, 094-3-01261, 094-3-01265, 094-3-01272, 094-3-01304, 094-3-01308, 101-3-01384, 093-3-01045, 093-3-01046, 093-3-01069, 084-3-00775, 073-3-00315, 091-3-00918, 091-3-00919, 073-3-00279, 094-3-01262, 071-3-00183, 092-3-00983, 094-3-01255, 064-3-00114, 072-3-00219, 072-3-00222, 072-3-00230, 072-3-00258, 081-3-00499, 081-3-00500, 064-3-00116, 064-3-00117, 092-3-01021, 073-3-00305, 073-3-00314, 082-3-22572, 082-3-22573, 101-3-01380, 073-3-00317, 074-3-00341, 091-3-00932, 094-3-01310, 101-3-01374, 082-3-00559, 092-3-00983, 094-3-01255, 094-3-01305, 062-3-00029, 093-3-01048, 094-3-01240, 102-3-01504 & 094-3-01243. Part number: 86207/6207 (230V) Serial #s: 112-3-01949, 114-3-02171 through 124-3-02764, 072-3-00247, 073-3-00266, 073-3-00282, 082-3-00564, 071-3-00132, 071-3-00152, 073-3-00309, 082-3-00533, 082-3-00534, 082-3-00565, 082-3-00568, 084-3-00768, 084-3-00770, 084-3-00777, 084-3-00778, 084-3-00779, 084-3-00780, 084-3-00781, 084-3-00787, 084-3-00788, 091-3-00836, 091-3-00877, 091-3-00878, 091-3-00902, 092-3-01007, 092-3-01008, 092-3-01011, 102-3-01423, 102-3-01426, 103-3-01592, 103-3-01593, 103-3-01594, 103-3-01595, 103-3-01601, 093-3-01072, 093-3-01073, 093-3-01076, 093-3-01078, 093-3-01084, 093-3-01085, 093-3-01086, 093-3-01087, 093-3-01088, 093-3-01104, 093-3-01105, 093-3-01106, 093-3-01107, 093-3-01108, 103-3-01573, 103-3-01574, 103-3-01575, 071-3-00178, 071-3-00180, 074-3-00393, 074-3-00394, 074-3-00395, 074-3-00396, 074-3-00404, 074-3-00405, 091-3-00904, 091-3-00905, 092-3-00939, 092-3-00948, 092-3-00949, 092-3-00951, 092-3-00962, 092-3-00963, 094-3-01178,094-3-01179, 094-3-01180, 094-3-01181, 094-3-01183, 084-3-00789, 084-3-00790, 084-3-00791, 084-3-00812, 084-3-00813, 084-3-00814, 084-3-00815 & 084-3-00816.",,"115V - 396 units; 230V - 385 units","During a label review it was discovered that both the Blanketrol III Operations (57201-N) & Operations & Technical (56201-Q) manuals had verbiage added back into the manual during ECN M111-4260 (released 12/29/2011) which was previously removed for clarification of the intended use and subsequent 501(K) approval.",9/3/2013,"09/03/2013",9/25/2013,"09/25/2013"
"Devices",66156,"Completed","GE Healthcare, LLC","Waukesha","WI","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution-USA (nationwide) including the states of CA, CO, CT, HI, IL , IA, KY, LA, MA, MI, NE, NY,OH, OK, TX, and WI, and the countries of UNITED KINGDOM, UNITED ARAB EMIRATES, TURKEY, TUNISIA, THAILAND, SYRIAN ARAB REPUBLIC, SWITZERLAND, SWEDEN, SPAIN, SOUTH AFRICA, SLOVAKIA, SINGAPORE, SAUDI ARABIA, RUSSIAN FEDERATION, REPUBLIC OF SERBIA, PORTUGAL, POLAND, PARAGUAY, NORWAY, NETHERLANDS, NEPAL, MEXICO, MALAYSIA, KUWAIT, REPUBLIC OF KOREA, JORDAN, JAPAN, ITALY, ISRAEL, IRELAND, IRAQ, INDONESIA, INDIA, HONG KONG, GREECE, GERMANY, FRANCE, FINLAND, ESTONIA, EGYPT, DENMARK, CZECH REPUBLIC, COSTA RICA, COLOMBIA, CHINA, CHILE, CANADA, BOSNIA AND HERZEGOVINA, BELGIUM, BAHRAIN, AUSTRIA, and AUSTRALIA.","Z-2201-2013","Class II","GE Healthcare, CARESCAPE Monitor B850. Intended for use in multiple areas within a professional healthcare facility.","Serial Number 6617967 6617968 6617969 6619157 6619158 6619159 6619160 6626633 6626634 6637287 6660104 6693980 6720596 6720597 6720598 6720599 6739266 CZC0044VY8 CZC0044VYL CZC0044VYY CZC0044VZ1 CZC0044VZ5 CZC0044VZ6 CZC0044VZ7 CZC0044VZ8 CZC0044VZB CZC0070P7B CZC0070P7G CZC0133FMM CZC0133FMS CZC0133FN7 CZC0182JL2 CZC0182JL8 CZC02211YN CZC0249CL3 CZC0249CL5 CZC0249CL7 CZC0249CLF CZC0249CLK CZC03336CT CZC03336D1 CZC03336D6 CZC0334KJ5 CZC0334KJ6 CZC0366ZR0 CZC0468W4H CZC1027W82 CZC1027W85 CZC1027W86 CZC1027W8C CZC1129Z65 CZC116B2N7 CZC9313455 CZC0016T0H CZC0016T0T CZC0044VY7 CZC0044VY9 CZC0044VYD CZC0044VYM CZC0044VYP CZC0044VYQ CZC0044VYR CZC0044VYV CZC0044VZ2 CZC0044VZ9 CZC0044VZC CZC0133FMJ CZC0207NVR CZC0207NVS CZC02211YD CZC02211YG CZC02211YT CZC0249CLJ CZC0322T5K CZC0334KJM CZC0369HKQ CZC1069WFK CZC1069WFT CZC1129Z6D CZC1129Z6Y CZC1129Z73 CZC94890S5 CZC94890S7 CZC94890SD CZC0322T5G CZC0322T5J CZC0070P7S CZC0133FN4 CZC02213JC CZC02213JF CZC02213JG CZC02213JJ CZC0526KZ1 CZC1069WF7 CZC1069WF9 CZC1129Z63 CZC1129Z6B CZC1129Z6C CZC1129Z74 CZC94890S1 CZC94890S8 CZC94890SC CZC94890SK CZC0070P82 CZC03336C8 CZC0107DR3 CZC0070P7X CZC0107DQ7 CZC0182JL7 CZC0182JLF CZC0207NVP CZC0334KJF CZC0474PTP CZC0474PVK CZC1027W8M CZC1069WF5 CZC1069WFB CZC1129Z68 CZC1129Z6R CZC1129Z6Z CZC0107DQ3 CZC0107DQR CZC0334KJJ CZC1027W7W CZC1069WF1 CZC1129Z64 CZC0107DQ6 CZC0107DQ8 CZC0334KJH CZC0334KJR CZC0474PTK CZC0526KZ6 CZC0526KZ8 CZC0107DQ9 CZC0107DR4 CZC02213J9 CZC02213JL CZC03336CJ CZC0468W53 CZC1129Z6J CZC1129Z6T CZC0107DQ1 CZC0107DQB CZC0107DQC CZC0107DQZ CZC03336CN CZC0366ZQT CZC0369HL1 CZC0474PV0 CZC0526KYN CZC1069WF3 CZC1129Z76 CZC0133FNB CZC02211YF CZC02211YH CZC0369HL2 CZC0232J70 CZC0182JL4 CZC0133FMY CZC0133FN0 CZC0133FN2 CZC02211YB CZC02211YQ CZC0249CLC CZC03336CM CZC0334KJC CZC0369HLL CZC0468W46 CZC0468W4Q CZC0468W4R CZC1027W8B CZC1027W8N CZC0249CLL CZC0044VYK CZC0474PTY CZC0044VZ4 CZC0070P78 CZC0070P7L CZC0070P7Q CZC0070P7T CZC0070P7V CZC0070P80 CZC0107DQK CZC0107DR1 CZC0207NW0 CZC0207NW3 CZC0207NVX CZC0207NVY CZC0249CL1 CZC",,"636 (53 US, 583 OUS)","GE Healthcare has recently become aware of an issue associated with the CARESCAPE Monitor B850 when used with the iCentral network. The iCentral must have the alarm management software license (L-NETM-00) and the alarm limit change option enabled to experience this issue. When changing the HR, SpO2 or Invasive pressure alarm limits from the iCentral over the network, the alarm priority on the CARESCAPETM Monitor B850 inadvertently changes from Escalating to the startup level of the escalation (e.g., low for HR Alarms). Alarms for other parameters are not affected. ",7/20/2011,"07/20/2011",9/25/2013,"09/25/2013"
"Drugs",66157,"Ongoing","Procter & Gamble Co","Mason","OH","US","Voluntary: Firm Initiated","Letter","Nationwide","D-1056-2013","Class II","Vicks NyQuil Cold and Flu Nighttime Relief, Liquid Twin Pack, (Acetaminophen 650mg, Dextromethorphan HBr 30mg, Doxylamine succinate 12.5mg), 12 fl oz (354 ml) bottles, Distributed by Procter & Gamble, Cincinnati, OH 45202, NDC 37000-807-12","Lot #s 31614334R1, 31814334R1, Exp 5/15; Twin packs were further packaged in display coded with following 4 Lot #s (display received by WalMart only): 3051A152HK, Exp 1/15, 3051A152HL, Exp. 1/15, 3051A152HM, Exp 1/15, 30746493F5, Exp 2/15",,"11,337 twin packs","Incorrect/ Undeclared Excipients: NyQuil Liquid Original bottles were inadvertently overwrapped with NyQuil Liquid Cherry information as a result the outer wrap does not correctly identify color additives, particularly FD&C Yellow No. 6 and FD&C Yellow 10.",8/29/2013,"08/29/2013",9/25/2013,"09/25/2013"
"Biologics",66158,"Completed","Blood Systems, Inc","Fargo","ND","US","Voluntary: Firm Initiated","Letter","North Dakota; California","B-0047-14","Class II","Red Blood Cells Leukocytes Reduced","W042510003654V; W042509082594Y; W0425090525442; W0425080449784; W042508029674K; 302980594; ",".","6 units","Blood products, collected from an ineligible donor, were distributed. ",8/13/2013,"08/13/2013",12/11/2013,"12/11/2013"
"Biologics",66158,"Completed","Blood Systems, Inc","Fargo","ND","US","Voluntary: Firm Initiated","Letter","North Dakota; California","B-0046-14","Class II","Red Blood Cells (Apheresis) Leukocytes Reduced","W042510071719M; W042510071719M; ",".","2 units","Blood products, collected from an ineligible donor, were distributed. ",8/13/2013,"08/13/2013",12/11/2013,"12/11/2013"
"Biologics",66159,"Terminated"," Lions Eye Bank For Long Island ","Valley Stream","NY","US","Voluntary: Firm Initiated","Letter","Uzbekistan","B-2491-13","Class III","Cornea","2011348C",".","1 cornea","Human cornea, recovered from a donor whose donor eligibility determination failed to ensure that the donor was free from risk factors for, and clinical evidence of infection due to relevant communicable disease agents and diseases, was distributed. ",7/13/2013,"07/13/2013",11/20/2013,"11/20/2013"
"Biologics",66160,"Terminated"," Lions Eye Bank For Long Island ","Valley Stream","NY","US","Voluntary: Firm Initiated","Letter","New York","B-2562-13","Class III","Cornea","2011335C; 2011336C",".","2 corneas","Human corneas, recovered from a donor whose donor eligibility determination failed to ensure that the donor was free from risk factors for, and clinical evidence of infection due to relevant communicable disease agents and diseases, were distributed. ",7/13/2013,"07/13/2013",11/20/2013,"11/20/2013"
"Biologics",66164,"Terminated"," Lions Eye Bank For Long Island ","Valley Stream","NY","US","Voluntary: Firm Initiated","Letter","New York","B-2487-13","Class II","Cornea","2009275C; 2009276C",".","2","Human corneas, recovered from a donor whose donor eligibility determination failed to ensure that the donor was free from risk factors for, and clinical evidence of infection due to relevant communicable disease agents and diseases, were distributed. ",7/13/2013,"07/13/2013",11/20/2013,"11/20/2013"
"Devices",66166,"Ongoing","Siemens Healthcare Diagnostics Inc","Norwood","MA","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution - USA Nationwide and in the countries of Algeria, Argentina, Australia, Austria, Bahrain, Bangladesh, Belgium, Bosnia Herzeg., Botswana, Brazil, Brunei, Bulgaria, Chile, Colombia, Croatia, Czech Republic, Denmark, Egypt, Estonia, Finland, France, Fren.Polynesia, Germany, Greece, Hong Kong, Hungary, Iceland, India, Indonesia, Iraq, Ireland, Israel, Italy, Ivory Coast, Japan, Kazakhstan, Kenya, Kuwait, Latvia, Lithuania, Luxembourg, Macedonia, Malaysia, Mayotte, Netherlands, New Caledonia, New Zealand, Norway, P.R. China, Philippines, Poland, Portugal, Qatar, Rep. of Yemen, Republic Korea, Romania, Russian Fed., Saudi Arabia, Serbia, Singapore, Slovakia, Slovenia, South Africa, Spain, Sweden, Switzerland, Taiwan, Thailand, Turkey, Turkmenistan, U.A.E., United Kingdom, Vatikancity, Venezuela, Vietnam,","Z-0102-2014","Class II","Siemens RAPIDPoint 400 system blood gas analyzer Product Usage: These systems are intended for near-patient and laboratory testing of blood gases, electrolytes, metabolites, total hemoglobin, and hemoglobin derivatives in arterial, venous, and capillary whole blood samples. The systems are capable of determining the following parameters: RAPIDPoint 400 pH, pC02, p02, Na+, K+, Ca++, Cl-, glucose, Hct RAPIDPoint 405 pH, pC02, p02, Na+, K+, Ca++, Cl-, glucose, tHb, F02Hb, FCOHb, FMetHb, FHHb, nBili ","All Serial Numbers",,"828 units","RAPIDPoint 400 Series, RAPIDPoint 500, or RAPIDLab 1200 Series blood gas analyzer, users can inadvertently enter a wrong patient ID on the demographics screen, which ultimately could lead to a misidentification of the sample",9/17/2012,"09/17/2012",11/6/2013,"11/06/2013"
"Devices",66166,"Ongoing","Siemens Healthcare Diagnostics Inc","Norwood","MA","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution - USA Nationwide and in the countries of Algeria, Argentina, Australia, Austria, Bahrain, Bangladesh, Belgium, Bosnia Herzeg., Botswana, Brazil, Brunei, Bulgaria, Chile, Colombia, Croatia, Czech Republic, Denmark, Egypt, Estonia, Finland, France, Fren.Polynesia, Germany, Greece, Hong Kong, Hungary, Iceland, India, Indonesia, Iraq, Ireland, Israel, Italy, Ivory Coast, Japan, Kazakhstan, Kenya, Kuwait, Latvia, Lithuania, Luxembourg, Macedonia, Malaysia, Mayotte, Netherlands, New Caledonia, New Zealand, Norway, P.R. China, Philippines, Poland, Portugal, Qatar, Rep. of Yemen, Republic Korea, Romania, Russian Fed., Saudi Arabia, Serbia, Singapore, Slovakia, Slovenia, South Africa, Spain, Sweden, Switzerland, Taiwan, Thailand, Turkey, Turkmenistan, U.A.E., United Kingdom, Vatikancity, Venezuela, Vietnam,","Z-0103-2014","Class II","Siemens RAPIDPoint 405 system blood gas analyzer Product PUsage: These systems are intended for near-patient and laboratory testing of blood gases, electrolytes, metabolites, total hemoglobin, and hemoglobin derivatives in arterial, venous, and capillary whole blood samples. The systems are capable of determining the following parameters: RAPIDPoint 400 pH, pC02, p02, Na+, K+, Ca++, Cl-, glucose, Hct RAPIDPoint 405 pH, pC02, p02, Na+, K+, Ca++, Cl-, glucose, tHb, F02Hb, FCOHb, FMetHb, FHHb, nBili","All Serial Numbers",," 4494 units","RAPIDPoint 400 Series, RAPIDPoint 500, or RAPIDLab 1200 Series blood gas analyzer, users can inadvertently enter a wrong patient ID on the demographics screen, which ultimately could lead to a misidentification of the sample",9/17/2012,"09/17/2012",11/6/2013,"11/06/2013"
"Devices",66166,"Ongoing","Siemens Healthcare Diagnostics Inc","Norwood","MA","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution - USA Nationwide and in the countries of Algeria, Argentina, Australia, Austria, Bahrain, Bangladesh, Belgium, Bosnia Herzeg., Botswana, Brazil, Brunei, Bulgaria, Chile, Colombia, Croatia, Czech Republic, Denmark, Egypt, Estonia, Finland, France, Fren.Polynesia, Germany, Greece, Hong Kong, Hungary, Iceland, India, Indonesia, Iraq, Ireland, Israel, Italy, Ivory Coast, Japan, Kazakhstan, Kenya, Kuwait, Latvia, Lithuania, Luxembourg, Macedonia, Malaysia, Mayotte, Netherlands, New Caledonia, New Zealand, Norway, P.R. China, Philippines, Poland, Portugal, Qatar, Rep. of Yemen, Republic Korea, Romania, Russian Fed., Saudi Arabia, Serbia, Singapore, Slovakia, Slovenia, South Africa, Spain, Sweden, Switzerland, Taiwan, Thailand, Turkey, Turkmenistan, U.A.E., United Kingdom, Vatikancity, Venezuela, Vietnam,","Z-0108-2014","Class II","Siemens RAPIDLab 1265 system blood gas analyzer Product Usage: RAPIDLab 1200 Systems: The Rapidlab 1200 systems are intended for in vitro diagnostic use by healthcare professionals in the quantitative testing of human whole blood. The systems can determine the following parameters: RAPIDLab 1240 pH, pC02, p02 RAPIDLab 1245 pH, pC02, p02, tHb, nBili, F02Hb, FCOHb, FMetHb, FHHb RAPIDLab 1260 pH, pC02, p02, Na+, K+, Ca++, Cl-, glucose, lactate RAPIDLab 1265 pH, pC02, p02, Na+, K+, Ca++, Cl-, glucose, lactate, tHb, nBili, F02Hb, FCOHb, FMetHb, FHHb ","All Serial Numbers",,"2939 units","RAPIDPoint 400 Series, RAPIDPoint 500, or RAPIDLab 1200 Series blood gas analyzer, users can inadvertently enter a wrong patient ID on the demographics screen, which ultimately could lead to a misidentification of the sample",9/17/2012,"09/17/2012",11/6/2013,"11/06/2013"
"Devices",66166,"Ongoing","Siemens Healthcare Diagnostics Inc","Norwood","MA","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution - USA Nationwide and in the countries of Algeria, Argentina, Australia, Austria, Bahrain, Bangladesh, Belgium, Bosnia Herzeg., Botswana, Brazil, Brunei, Bulgaria, Chile, Colombia, Croatia, Czech Republic, Denmark, Egypt, Estonia, Finland, France, Fren.Polynesia, Germany, Greece, Hong Kong, Hungary, Iceland, India, Indonesia, Iraq, Ireland, Israel, Italy, Ivory Coast, Japan, Kazakhstan, Kenya, Kuwait, Latvia, Lithuania, Luxembourg, Macedonia, Malaysia, Mayotte, Netherlands, New Caledonia, New Zealand, Norway, P.R. China, Philippines, Poland, Portugal, Qatar, Rep. of Yemen, Republic Korea, Romania, Russian Fed., Saudi Arabia, Serbia, Singapore, Slovakia, Slovenia, South Africa, Spain, Sweden, Switzerland, Taiwan, Thailand, Turkey, Turkmenistan, U.A.E., United Kingdom, Vatikancity, Venezuela, Vietnam,","Z-0107-2014","Class II","Siemens RAPIDLab 1260 system blood gas analyzer Product Usage: RAPIDLab 1200 Systems: The Rapidlab 1200 systems are intended for in vitro diagnostic use by healthcare professionals in the quantitative testing of human whole blood. The systems can determine the following parameters: RAPIDLab 1240 pH, pC02, p02 RAPIDLab 1245 pH, pC02, p02, tHb, nBili, F02Hb, FCOHb, FMetHb, FHHb RAPIDLab 1260 pH, pC02, p02, Na+, K+, Ca++, Cl-, glucose, lactate RAPIDLab 1265 pH, pC02, p02, Na+, K+, Ca++, Cl-, glucose, lactate, tHb, nBili, F02Hb, FCOHb, FMetHb, FHHb ","All Serial Numbers",,"140 units","RAPIDPoint 400 Series, RAPIDPoint 500, or RAPIDLab 1200 Series blood gas analyzer, users can inadvertently enter a wrong patient ID on the demographics screen, which ultimately could lead to a misidentification of the sample",9/17/2012,"09/17/2012",11/6/2013,"11/06/2013"
"Devices",66166,"Ongoing","Siemens Healthcare Diagnostics Inc","Norwood","MA","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution - USA Nationwide and in the countries of Algeria, Argentina, Australia, Austria, Bahrain, Bangladesh, Belgium, Bosnia Herzeg., Botswana, Brazil, Brunei, Bulgaria, Chile, Colombia, Croatia, Czech Republic, Denmark, Egypt, Estonia, Finland, France, Fren.Polynesia, Germany, Greece, Hong Kong, Hungary, Iceland, India, Indonesia, Iraq, Ireland, Israel, Italy, Ivory Coast, Japan, Kazakhstan, Kenya, Kuwait, Latvia, Lithuania, Luxembourg, Macedonia, Malaysia, Mayotte, Netherlands, New Caledonia, New Zealand, Norway, P.R. China, Philippines, Poland, Portugal, Qatar, Rep. of Yemen, Republic Korea, Romania, Russian Fed., Saudi Arabia, Serbia, Singapore, Slovakia, Slovenia, South Africa, Spain, Sweden, Switzerland, Taiwan, Thailand, Turkey, Turkmenistan, U.A.E., United Kingdom, Vatikancity, Venezuela, Vietnam,","Z-0104-2014","Class II","Siemens RAPIDPoint 500 system blood gas analyzer Product Usage: RAPIDPoint 500 System: The RAPIDPoint 500 system is designed for professional use in a point-of-care or laboratory environment. This system tests blood gases, electrolytes, metabolites, total hemoglobin, and hemoglobin derivatives in arterial, venous, and capillary whole blood samples. The following parameters are tested: pH, pC02, p02, Na+, K+, Ca++, Cl-, glucose, lactate, tHb, F02Hb, FCOHb, FMetHb, FHHb, nBili ","All Serial Numbers",,"2152 units","RAPIDPoint 400 Series, RAPIDPoint 500, or RAPIDLab 1200 Series blood gas analyzer, users can inadvertently enter a wrong patient ID on the demographics screen, which ultimately could lead to a misidentification of the sample",9/17/2012,"09/17/2012",11/6/2013,"11/06/2013"
"Devices",66166,"Ongoing","Siemens Healthcare Diagnostics Inc","Norwood","MA","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution - USA Nationwide and in the countries of Algeria, Argentina, Australia, Austria, Bahrain, Bangladesh, Belgium, Bosnia Herzeg., Botswana, Brazil, Brunei, Bulgaria, Chile, Colombia, Croatia, Czech Republic, Denmark, Egypt, Estonia, Finland, France, Fren.Polynesia, Germany, Greece, Hong Kong, Hungary, Iceland, India, Indonesia, Iraq, Ireland, Israel, Italy, Ivory Coast, Japan, Kazakhstan, Kenya, Kuwait, Latvia, Lithuania, Luxembourg, Macedonia, Malaysia, Mayotte, Netherlands, New Caledonia, New Zealand, Norway, P.R. China, Philippines, Poland, Portugal, Qatar, Rep. of Yemen, Republic Korea, Romania, Russian Fed., Saudi Arabia, Serbia, Singapore, Slovakia, Slovenia, South Africa, Spain, Sweden, Switzerland, Taiwan, Thailand, Turkey, Turkmenistan, U.A.E., United Kingdom, Vatikancity, Venezuela, Vietnam,","Z-0105-2014","Class II","Siemens RAPIDLab 1240 system blood gas analyzer Product Usage: RAPIDLab 1200 Systems: The Rapidlab 1200 systems are intended for in vitro diagnostic use by healthcare professionals in the quantitative testing of human whole blood. The systems can determine the following parameters: RAPIDLab 1240 pH, pC02, p02 RAPIDLab 1245 pH, pC02, p02, tHb, nBili, F02Hb, FCOHb, FMetHb, FHHb RAPIDLab 1260 pH, pC02, p02, Na+, K+, Ca++, Cl-, glucose, lactate RAPIDLab 1265 pH, pC02, p02, Na+, K+, Ca++, Cl-, glucose, lactate, tHb, nBili, F02Hb, FCOHb, FMetHb, FHHb ","All Serial Numbers",,"179 units","RAPIDPoint 400 Series, RAPIDPoint 500, or RAPIDLab 1200 Series blood gas analyzer, users can inadvertently enter a wrong patient ID on the demographics screen, which ultimately could lead to a misidentification of the sample",9/17/2012,"09/17/2012",11/6/2013,"11/06/2013"
"Devices",66166,"Ongoing","Siemens Healthcare Diagnostics Inc","Norwood","MA","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution - USA Nationwide and in the countries of Algeria, Argentina, Australia, Austria, Bahrain, Bangladesh, Belgium, Bosnia Herzeg., Botswana, Brazil, Brunei, Bulgaria, Chile, Colombia, Croatia, Czech Republic, Denmark, Egypt, Estonia, Finland, France, Fren.Polynesia, Germany, Greece, Hong Kong, Hungary, Iceland, India, Indonesia, Iraq, Ireland, Israel, Italy, Ivory Coast, Japan, Kazakhstan, Kenya, Kuwait, Latvia, Lithuania, Luxembourg, Macedonia, Malaysia, Mayotte, Netherlands, New Caledonia, New Zealand, Norway, P.R. China, Philippines, Poland, Portugal, Qatar, Rep. of Yemen, Republic Korea, Romania, Russian Fed., Saudi Arabia, Serbia, Singapore, Slovakia, Slovenia, South Africa, Spain, Sweden, Switzerland, Taiwan, Thailand, Turkey, Turkmenistan, U.A.E., United Kingdom, Vatikancity, Venezuela, Vietnam,","Z-0106-2014","Class II","Siemens RAPIDLab 1245 system blood gas analyzer Product Usage: RAPIDLab 1200 Systems: The Rapidlab 1200 systems are intended for in vitro diagnostic use by healthcare professionals in the quantitative testing of human whole blood. The systems can determine the following parameters: RAPIDLab 1240 pH, pC02, p02 RAPIDLab 1245 pH, pC02, p02, tHb, nBili, F02Hb, FCOHb, FMetHb, FHHb RAPIDLab 1260 pH, pC02, p02, Na+, K+, Ca++, Cl-, glucose, lactate RAPIDLab 1265 pH, pC02, p02, Na+, K+, Ca++, Cl-, glucose, lactate, tHb, nBili, F02Hb, FCOHb, FMetHb, FHHb ","All Serial Numbers",,"274 units","RAPIDPoint 400 Series, RAPIDPoint 500, or RAPIDLab 1200 Series blood gas analyzer, users can inadvertently enter a wrong patient ID on the demographics screen, which ultimately could lead to a misidentification of the sample",9/17/2012,"09/17/2012",11/6/2013,"11/06/2013"
"Devices",66166,"Ongoing","Siemens Healthcare Diagnostics Inc","Norwood","MA","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution - USA Nationwide and in the countries of Algeria, Argentina, Australia, Austria, Bahrain, Bangladesh, Belgium, Bosnia Herzeg., Botswana, Brazil, Brunei, Bulgaria, Chile, Colombia, Croatia, Czech Republic, Denmark, Egypt, Estonia, Finland, France, Fren.Polynesia, Germany, Greece, Hong Kong, Hungary, Iceland, India, Indonesia, Iraq, Ireland, Israel, Italy, Ivory Coast, Japan, Kazakhstan, Kenya, Kuwait, Latvia, Lithuania, Luxembourg, Macedonia, Malaysia, Mayotte, Netherlands, New Caledonia, New Zealand, Norway, P.R. China, Philippines, Poland, Portugal, Qatar, Rep. of Yemen, Republic Korea, Romania, Russian Fed., Saudi Arabia, Serbia, Singapore, Slovakia, Slovenia, South Africa, Spain, Sweden, Switzerland, Taiwan, Thailand, Turkey, Turkmenistan, U.A.E., United Kingdom, Vatikancity, Venezuela, Vietnam,","Z-0106-2014","Class II","Siemens RAPIDLab 1245 system blood gas analyzer Product Usage: RAPIDLab 1200 Systems: The Rapidlab 1200 systems are intended for in vitro diagnostic use by healthcare professionals in the quantitative testing of human whole blood. The systems can determine the following parameters: RAPIDLab 1240 pH, pC02, p02 RAPIDLab 1245 pH, pC02, p02, tHb, nBili, F02Hb, FCOHb, FMetHb, FHHb RAPIDLab 1260 pH, pC02, p02, Na+, K+, Ca++, Cl-, glucose, lactate RAPIDLab 1265 pH, pC02, p02, Na+, K+, Ca++, Cl-, glucose, lactate, tHb, nBili, F02Hb, FCOHb, FMetHb, FHHb ","All Serial Numbers",,"274 units","RAPIDPoint 400 Series, RAPIDPoint 500, or RAPIDLab 1200 Series blood gas analyzer, users can inadvertently enter a wrong patient ID on the demographics screen, which ultimately could lead to a misidentification of the sample",9/17/2012,"09/17/2012",11/6/2013,"11/06/2013"
"Devices",66166,"Ongoing","Siemens Healthcare Diagnostics Inc","Norwood","MA","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution - USA Nationwide and in the countries of Algeria, Argentina, Australia, Austria, Bahrain, Bangladesh, Belgium, Bosnia Herzeg., Botswana, Brazil, Brunei, Bulgaria, Chile, Colombia, Croatia, Czech Republic, Denmark, Egypt, Estonia, Finland, France, Fren.Polynesia, Germany, Greece, Hong Kong, Hungary, Iceland, India, Indonesia, Iraq, Ireland, Israel, Italy, Ivory Coast, Japan, Kazakhstan, Kenya, Kuwait, Latvia, Lithuania, Luxembourg, Macedonia, Malaysia, Mayotte, Netherlands, New Caledonia, New Zealand, Norway, P.R. China, Philippines, Poland, Portugal, Qatar, Rep. of Yemen, Republic Korea, Romania, Russian Fed., Saudi Arabia, Serbia, Singapore, Slovakia, Slovenia, South Africa, Spain, Sweden, Switzerland, Taiwan, Thailand, Turkey, Turkmenistan, U.A.E., United Kingdom, Vatikancity, Venezuela, Vietnam,","Z-0103-2014","Class II","Siemens RAPIDPoint 405 system blood gas analyzer Product PUsage: These systems are intended for near-patient and laboratory testing of blood gases, electrolytes, metabolites, total hemoglobin, and hemoglobin derivatives in arterial, venous, and capillary whole blood samples. The systems are capable of determining the following parameters: RAPIDPoint 400 pH, pC02, p02, Na+, K+, Ca++, Cl-, glucose, Hct RAPIDPoint 405 pH, pC02, p02, Na+, K+, Ca++, Cl-, glucose, tHb, F02Hb, FCOHb, FMetHb, FHHb, nBili","All Serial Numbers",,"2152 units","RAPIDPoint 400 Series, RAPIDPoint 500, or RAPIDLab 1200 Series blood gas analyzer, users can inadvertently enter a wrong patient ID on the demographics screen, which ultimately could lead to a misidentification of the sample",9/17/2012,"09/17/2012",11/6/2013,"11/06/2013"
"Devices",66166,"Ongoing","Siemens Healthcare Diagnostics Inc","Norwood","MA","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution - USA Nationwide and in the countries of Algeria, Argentina, Australia, Austria, Bahrain, Bangladesh, Belgium, Bosnia Herzeg., Botswana, Brazil, Brunei, Bulgaria, Chile, Colombia, Croatia, Czech Republic, Denmark, Egypt, Estonia, Finland, France, Fren.Polynesia, Germany, Greece, Hong Kong, Hungary, Iceland, India, Indonesia, Iraq, Ireland, Israel, Italy, Ivory Coast, Japan, Kazakhstan, Kenya, Kuwait, Latvia, Lithuania, Luxembourg, Macedonia, Malaysia, Mayotte, Netherlands, New Caledonia, New Zealand, Norway, P.R. China, Philippines, Poland, Portugal, Qatar, Rep. of Yemen, Republic Korea, Romania, Russian Fed., Saudi Arabia, Serbia, Singapore, Slovakia, Slovenia, South Africa, Spain, Sweden, Switzerland, Taiwan, Thailand, Turkey, Turkmenistan, U.A.E., United Kingdom, Vatikancity, Venezuela, Vietnam,","Z-0108-2014","Class II","Siemens RAPIDLab 1265 system blood gas analyzer Product Usage: RAPIDLab 1200 Systems: The Rapidlab 1200 systems are intended for in vitro diagnostic use by healthcare professionals in the quantitative testing of human whole blood. The systems can determine the following parameters: RAPIDLab 1240 pH, pC02, p02 RAPIDLab 1245 pH, pC02, p02, tHb, nBili, F02Hb, FCOHb, FMetHb, FHHb RAPIDLab 1260 pH, pC02, p02, Na+, K+, Ca++, Cl-, glucose, lactate RAPIDLab 1265 pH, pC02, p02, Na+, K+, Ca++, Cl-, glucose, lactate, tHb, nBili, F02Hb, FCOHb, FMetHb, FHHb ","All Serial Numbers",,"2939 units","RAPIDPoint 400 Series, RAPIDPoint 500, or RAPIDLab 1200 Series blood gas analyzer, users can inadvertently enter a wrong patient ID on the demographics screen, which ultimately could lead to a misidentification of the sample",9/17/2012,"09/17/2012",11/6/2013,"11/06/2013"
"Food",66167,"Ongoing","Garden-Fresh Foods, Inc.","Milwaukee","WI","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","retail Spartan stores located in MI and Toledo, OH. Expanded recall: WI, MN, IA, IL, OH, IN, TX, FL, MA,MO, MI, PA, AZ, CA.","F-1911-2013","Class I","spartan fresh selections american potato salad, Net Wt. 16 oz (1 LB) 454g. UPC 11213-90320.","Use by 09/06/13/04",".","do not know","One lot of Spartan Fresh Selections American Potato Salad has the potential to be contaminated with Listeria monocytogenes.",8/30/2013,"08/30/2013",10/2/2013,"10/02/2013"
"Devices",66168,"Ongoing","GE Healthcare, LLC","Waukesha","WI","US","Voluntary: Firm Initiated","Letter","Worldwide distribution: US (nationwide) including states of : PA and TN; countries of: FRANCE and SINGAPORE.","Z-2253-2013","Class II","GE Healthcare Discovery IGS 730 Cardiovascular X-Ray Imaging System. The angiography X-ray systems are indicated for use in generating fluoroscopic and rotational images of human anatomy for cardiovascular, vascular and non-vascular, diagnostic and interventional procedures. Additionally, with the OR table, the angiographic X-ray systems are indicated for use in generating fluoroscopic and rotational images of human anatomy for image guided surgical procedures. The OR table is suitable for interventional and surgical procedures.","Mfg Lot or Serial # 00000611882BU2 00000612803BU7 00000613979BU4 00000620447BU3 ",,"4 (2 US, 2 OUS)","GE Healthcare has recently become aware of a potential safety issue with respect to Discovery IGS 730 Imaging Systems. A patient data management error may prevent the Discovery IGS 730 Imaging System from booting on start-up or re-booting during procedure. The boot issue may occur when a large amount of patient data remains in the browser and is not deleted. The inability to boot the system may lead to a complete loss of real-time interventional imaging functionality. No injuries have been reported due to this issue.",6/19/2013,"06/19/2013",9/25/2013,"09/25/2013"
"Drugs",66169,"Ongoing","Watson Laboratories Inc","Corona","CA","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Nationwide","D-1061-2013","Class III","Hydrocodone Bitartrate and Acetaminophen Tablets, 7.5 mg/650 mg Tablets, 500 Count Bottle, Manufactured by: Watson Laboratories, Inc, Cocona, CA 92880, NDC 0591-2611-05. ","Lot 706224A and 706225A, Exp. 04/15. ",,"875 bottles","Defective Container: Defective bottles may not have tamper evident seals properly seated, and therefore it may be difficult to determine if the product had been opened or tampered with. ",8/30/2013,"08/30/2013",9/25/2013,"09/25/2013"
"Veterinary",66170,"Ongoing","Zoetis Inc","Florham Park","NJ","US","Voluntary: Firm Initiated","Letter","Product was distributed to the following states: GA, AR, OK, TX, and VA.","V-001-2014","Class II","Bio-Cox Granular 60 Alpharma Brand of salinomycin sodium Type A Medicated Article Net Wt 50 LB, Marketed by Alpharma Inc. Bridgewater, New Jersey 08807, NADA # 128-686","HSK10293, HSK10294, HSK10295, HSK10296, HSK10297, HSK10298, HSK10299, HSK10300, HSK10301, HSK10302, HSK10303, HSK10304, HSK10305, HSK10306, HSK10307, and HSK10308.",".","1280 bags","Stability failure",9/9/2013,"09/09/2013",11/13/2013,"11/13/2013"
"Devices",66171,"Ongoing","Boston Scientific CRM Corp","Saint Paul","MN","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution-USA (nationwide) including Guam and Puerto Ricoand the countries of Argentina, Aruba, Australia, Austria, Belgium, Bermuda, Brazil, Canada, Chile, Hong Kong, Colombia, Costa Rica, Cyprus, Czech Republic, Denmark, Ecuador, Egypt, El Salvador, Finland, France, Gabon, Germany, Greece, Hungary, Iran, Ireland, Israel, Italy, Japan, Jordan, Kuwait, Latvia, Lebanon, Malaysia, Mexico, Netherlands, Netherlands Antilles, New Zealand, Norway, Panama, Peru, Poland, Portugal, Saudi Arabia, Singapore, Si Lanka, Slovakia, Slovenia, South Africa, South Korea, Spain, Sweden, Switzerland, Syria, Taiwan, Thailand, Trinidad, UK, United Arab Republic, and Venezuela.","Z-0026-2014","Class II","Boston Scientific TELIGEN, Implantable Cardiac Defibrillator models E102, E110, the following models are not available in the US: models F102, F110, F111. Sterilized using ethylene oxide. Boston Scientific, 4100 Hamline Avenue North, St. Paul, MN 55112-5798 USA. Indicated for patients who are at risk for sudden cardiac death due to ventricular arrhythmias and may require pacing support. ","Model E102, Serial Numbers: 000138, 000139, 000140, 000142, 000145, 000146, 000147, 000151, 000152, 000153, 000154, 000161, 000162, 000163, 000166, 000167, 000169, 000170, 000172, 000173, 000174, 000175, 000176, 000177, 000178, 000182, 000183, 000184, 000185, 000187, 000188, 000191, 000192, 000193, 000194, 000196, 000199, 000200, 000202, 000203, 000204, 000207, 000209, 000210, 000213, 000214, 000215, 000216, 000218, 000219, 000220, 000221, 000222, 000224, 000226, 000227, 000228, 000229, 000230, 000232, 000234, 000235, 000236, 000240, 000241, 000244, 000247, 000248, 000249, 000251, 000252, 000254, 000256, 000258, 000260, 000262, 000263, 000265, 000266, 000268, 000269, 000270, 000271, 000272, 000273, 000274, 000275, 000276, 000277, 000278, 000282, 000284, 000287, 000288, 000289, 000290, 000292, 000294, 000295, 000297, 000299, 000300, 000302, 000304, 000306, 000307, 000309, 000310, 000311, 000314, 000316, 000321, 000322, 000323, 000324, 000325, 000330, 000332, 000334, 000335, 000337, 000338, 000339, 000340, 000342, 000343, 000344, 000346, 000347, 000349, 000350, 000351, 000352, 000353, 000356, 000358, 000361, 000363, 000365, 000366, 000367, 000368, 000372, 000376, 000380, 000381, 000382, 000383, 000384, 000385, 000387, 000389, 000390, 000391, 000392, 000395, 000397, 000398, 000402, 000404, 000406, 000407, 000408, 000411, 000415, 000419, 000420, 000421, 000422, 000423, 000424, 000425, 000426, 000428, 000429, 000430, 000431, 000434, 000435, 000436, 000438, 000439, 000440, 000443, 000445, 000447, 000448, 000449, 000451, 000453, 000454, 000456, 000457, 000458, 000460, 000461, 000462, 000463, 000464, 000465, 000467, 000470, 000472, 000475, 000477, 000479, 000480, 000483, 000484, 000485, 000487, 000490, 000491, 000492, 000493, 000497, 000498, 000500, 000502, 000503, 000505, 000507, 000508, 000509, 000510, 000513, 000518, 000519, 000520, 000521, 000523, 000526, 000529, 000530, 000533, 000534, 000537, 000541, 000543, 000544, 000545, 000548, 000549, 000550, 000552, 000553, 000555, 000556, 000557, 000558, 000559, 000560, 0"," 250685, 250689, 250692, 250693, 250694, 250696, 250697, 250698, 250702, 250703, 250704, 250705, 250707, 250708, 250709, 250711, 250712, 250713, 250714, 250715, 250716, 250719, 250720, 250721, 250723, 250725, 250727, 250728, 250730, 250731, 250732, 250734, 250736, 250738, 250739, 250760, 250762, 250763, 250765, 250766, 250767, 250768, 250771, 250772, 250773, 250775, 250776, 250777, 250778, 250780, 250781, 250782, 250784, 250785, 250788, 250789, 250790, 250791, 250792, 250793, 250794, 250796, 250797, 250798, 250799, 250800, 250801, 250802, 250804, 250805, 250807, 250808, 250810, 250815, 250816, 250817, 250818, 250819, 250820, 250821, 250824, 250825, 250826, 250828, 250829, 250830, 250831, 250832, 250835, 250836, 250837, 250838, 250839, 250840, 250842, 250843, 250845, 250846, 250847, 250848, 250849, 250851, 250852, 250853, 250854, 250855, 250856, 250857, 250859, 250860, 250861, 250863, 250865, 250867, 250868, 250869, 250871, 250872, 250873, 250874, 250875, 250876, 250877, 250879, 250881, 250882, 250883, 250885, 250886, 250887, 250888, 250889, 250890, 250891, 250892, 250893, 250894, 250896, 250897, 250898, 250900, 250901, 250902, 250903, 250905, 250906, 250909, 250910, 250911, 250912, 250913, 250915, 250917, 250919, 250922, 250923, 250924, 250925, 250926, 250927, 250928, 250929, 250931, 250933, 250938, 250944, 250945, 250946, 250947, 250950, 250952, 250953, 250966, 250972, 250974, 250975, 250976, 250981, 250985, 250986, 250988, 250990, 250993, 250998, 250999, 251002, 251009, 251011, 251012, 251015, 251017, 251020, 251022, 251023, 251026, 251028, 251031, 251035, 251039, 251042, 251046, 251051, 251052, 251053, 251054, 251055, 251056, 251059, 251061, 251063, 251067, 251069, 251075, 251078, 251081, 251086, 251087, 251093, 251101, 251102, 251103, 251106, 251110, 251112, 251115, 251117, 251120, 251123, 251128, 251129, 251131, 251132, 251135, 251137, 251138, 251139, 251140, 251143, 251144, 251145, 251148, 251149, 251150, 251153, 251155, 251158, 251159, 251163, 251168, 251175, 251196, 251202, 251203, 251205, 251208, 2512","38,500 total worldwide","The performance of a low voltage capacitor in a subset of COGNIS CRT-Ds and TELIGEN ICDs manufactured prior to December 2009, may be compromised over time, causing increased current drain that can lead to premature battery depletion.",8/29/2013,"08/29/2013",10/23/2013,"10/23/2013"
"Devices",66171,"Ongoing","Boston Scientific CRM Corp","Saint Paul","MN","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution-USA (nationwide) including Guam and Puerto Ricoand the countries of Argentina, Aruba, Australia, Austria, Belgium, Bermuda, Brazil, Canada, Chile, Hong Kong, Colombia, Costa Rica, Cyprus, Czech Republic, Denmark, Ecuador, Egypt, El Salvador, Finland, France, Gabon, Germany, Greece, Hungary, Iran, Ireland, Israel, Italy, Japan, Jordan, Kuwait, Latvia, Lebanon, Malaysia, Mexico, Netherlands, Netherlands Antilles, New Zealand, Norway, Panama, Peru, Poland, Portugal, Saudi Arabia, Singapore, Si Lanka, Slovakia, Slovenia, South Africa, South Korea, Spain, Sweden, Switzerland, Syria, Taiwan, Thailand, Trinidad, UK, United Arab Republic, and Venezuela.","Z-0025-2014","Class II","Boston Scientific COGNIS CRT-D, Cardiac Resynchronization Therapy Defibrillator, models N118, N119. The following models are not available in the US: models N106, N107, P106, P107. Sterilized using ethylene oxide. Boston Scientific, 4100 Hamline Avenue North, St. Paul, MN 55112-5798 USA. Indicated for patients who are at risk for sudden cardiac death due to ventricular arrhythmias and may require pacing support.","Model N118, Serial numbers: 559191, 559192, 559195, 559196, 559200, 559201, 559202, 559203, 559210, 559211, 559212, 559215, 559222, 559223, 559225, 559226, 559231, 559232, 559236, 559238, 559239, 559240, 559241, 559242, 559245, 559247, 559250, 559251, 559253, 559257, 559260, 559262, 559263, 559266, 559267, 559272, 559273, 559275, 559277, 559278, 559279, 559281, 559282, 559283, 559286, 559289, 559292, 559294, 559298, 559300, 559301, 559303, 559306, 559307, 559314, 559317, 559318, 559319, 559321, 559322, 559324, 559325, 559327, 559330, 559334, 559336, 559338, 559339, 559340, 559341, 559342, 559343, 559344, 559349, 559350, 559353, 559355, 559359, 559361, 559368, 559372, 559373, 559374, 559378, 559379, 559381, 559382, 559384, 559385, 559388, 559389, 559391, 559393, 559394, 559395, 559396, 559397, 559398, 559399, 559400, 559405, 559410, 559412, 559413, 559415, 559416, 559417, 559418, 559419, 559420, 559423, 559426, 559428, 559429, 559431, 559435, 559437, 559438, 559439, 559444, 559446, 559448, 559449, 559451, 559453, 559454, 559457, 559459, 559460, 559462, 559463, 559465, 559466, 559467, 559468, 559469, 559471, 559474, 559475, 559476, 559478, 559483, 559484, 559489, 559491, 559492, 559493, 559496, 559498, 559499, 559503, 559504, 559508, 559512, 559514, 559515, 559519, 559525, 559527, 559528, 559530, 559531, 559534, 559535, 559538, 559539, 559540, 559541, 559547, 559571, 559573, 559575, 559577, 559579, 559580, 559581, 559585, 559586, 559587, 559589, 559617, 559618, 559619, 559621, 559623, 559624, 559626, 559627, 559634, 559647, 559649, 559650, 559653, 559654, 559658, 559659, 559684, 559685, 559686, 559704, 559705, 559706, 559708, 559710, 559715, 559717, 559718, 559719, 559724, 559725, 559726, 559729, 559730, 559732, 559733, 559739, 559741, 559743, 559745, 559747, 559748, 559762, 559763, 559764, 559765, 559769, 559770, 559771, 559773, 559775, 559778, 559781, 559782, 559785, 559788, 559789, 559795, 559801, 559802, 559807, 559809, 559810, 559811, 559812, 559814, 559816, 559818, 559822, 559826, 559828, 559830, 559833, 5"," 042821, 042822, 042825, 042826, 042827, 042829, 042830, 042831, 042832, 042833, 042834, 042835, 042836, 042839, 042840, 042842, 042844, 042845, 042846, 042848, 042849, 042850, 042851, 042853, 042854, 042855, 042856, 042857, 042858, 042861, 042862, 042865, 042866, 042867, 042870, 043072, 043073, 043075, 043076, 043078, 043161, 043164, 043165, 043166, 043171, 043173, 043175, 043181, 043182, 043186, 043189, 043191, 043192, 043193, 043194, 043195, 043206, 043208, 043210, 043211, 043212, 043213, 043215, 043216, 043223, 043224, 043226, 043227, 043228, 043231, 043233, 043236, 043238, 043239, 043241, 043242, 043243, 043253, 043254, 043256, 043257, 043259, 043260, 043261, 043698, 043700, 043702, 043704, 043705, 043707, 043708, 043709, 043711, 043712, 043713, 043714, 043715, 043716, 043717, 043718, 043720, 043722, 043723, 043724, 043727, 043728, 043730, 043731, 043733, 043735, 043736, 043737, 043754, 043755, 043757, 043758, 043759, 043761, 043763, 043804, 043806, 043809, 043811, 043812, 043818, 043821, 043824, 043825, 043826, 043827, 043828, 043830, 043831, 043832, 043833, 043834, 043836, 043837, 043838, 043839, 043841, 043842, 043843, 043864, 043865, 043866, 043867, 043868, 043870, 043871, 043872, 043873, 043874, 043875, 043876, 043878, 043880, 043881, 043986, 043989, 043991, 043992, 043993, 043994, 043998, 043999, 044002, 044003, 044006, 044007, 044008, 044009, 044010, 044013, 044018, 044019, 044021, 044022, 044023, 044024, 044025, 044026, 044027, 044028, 044030, 044033, 044054, 044057, 044058, 044059, 044060, 044061, 044062, 044063, 044064, 044065, 044066, 044067, 044068, 044069, 044072, 044354, 044356, 044358, 044359, 044360, 044362, 044365, 044366, 044368, 044369, 044371, 044373, 044375, 044376, 044377, 044378, 044379, 044381, 044385, 044386, 044387, 044390, 044391, 044392, 044394, 044395, 044396, 044401, 044403, 044420, 044421, 044422, 044423, 044424, 044427, 044428, 044658, 044659, 044783, 044785, 044786, 044787, 044788, 044789, 044790, 044792, 044793, 044794, 044795, 044796, 044797, 044799, 044800, 044801, 0448","38,500 total worldwide","The performance of a low voltage capacitor in a subset of COGNIS CRT-Ds and TELIGEN ICDs manufactured prior to December 2009, may be compromised over time, causing increased current drain that can lead to premature battery depletion.",8/29/2013,"08/29/2013",10/23/2013,"10/23/2013"
"Drugs",66172,"Ongoing","Medaus, Inc.","Birmingham","AL","US","Voluntary: Firm Initiated","Telephone","Nationwide","D-1050-2013","Class II","Taurine 50 mg/mL PF, 100 mL, Medaus Pharmacy 1-800-526-9183","LOT # 130618-64, BUD: 12/15/2013",,"1660 mL","Lack of Assurance of Sterility: The product lots are being recalled due to laboratory results (from a contract lab) indicating microbial contamination. The FDA was concerned test results obtained from the recalling firm's contract testing lab may not be reliable. Hence the sterility of the products cannot be assured. ",8/23/2013,"08/23/2013",9/25/2013,"09/25/2013"
"Drugs",66172,"Ongoing","Medaus, Inc.","Birmingham","AL","US","Voluntary: Firm Initiated","Telephone","Nationwide","D-1055-2013","Class II","NA Ascorbate 500 mg/mL, non corn PF, 100ML, Medaus Pharmacy, 1-800-526-9183","LOT # 130613-8, Exp 12/10/2013",,"8750 mL","Lack of Assurance of Sterility: The product lots are being recalled due to laboratory results (from a contract lab) indicating microbial contamination. The FDA was concerned test results obtained from the recalling firm's contract testing lab may not be reliable. Hence the sterility of the products cannot be assured. ",8/23/2013,"08/23/2013",9/25/2013,"09/25/2013"
"Drugs",66172,"Ongoing","Medaus, Inc.","Birmingham","AL","US","Voluntary: Firm Initiated","Telephone","Nationwide","D-1053-2013","Class II","Magnesium Chl 200 mg/mL PF, 100 mL, Medaus Pharmacy 1-800-526-9183","LOT # 130307-60, Exp 9/3/2013",,"1880 mL","Lack of Assurance of Sterility: The product lots are being recalled due to laboratory results (from a contract lab) indicating microbial contamination. The FDA was concerned test results obtained from the recalling firm's contract testing lab may not be reliable. Hence the sterility of the products cannot be assured. ",8/23/2013,"08/23/2013",9/25/2013,"09/25/2013"
"Drugs",66172,"Ongoing","Medaus, Inc.","Birmingham","AL","US","Voluntary: Firm Initiated","Telephone","Nationwide","D-1048-2013","Class II","Testosterone Cyp 200 mg/mL, W/Pres. (Benzyl ETOH), 3 mL, Medaus pharmacy 1-800-526-9183","LOT # 130508-1, BUD: 11/16/2013",,"1198 mL","Lack of Assurance of Sterility: The product lots are being recalled due to laboratory results (from a contract lab) indicating microbial contamination. The FDA was concerned test results obtained from the recalling firm's contract testing lab may not be reliable. Hence the sterility of the products cannot be assured. ",8/23/2013,"08/23/2013",9/25/2013,"09/25/2013"
"Drugs",66172,"Ongoing","Medaus, Inc.","Birmingham","AL","US","Voluntary: Firm Initiated","Telephone","Nationwide","D-1052-2013","Class II","Pyridoxine HCL 100 mg/mL NS (PF), 30 mL, Medaus Pharmacy 1-800-526-9183","LOT # 130531-31, Exp 11/27/2013",,"2970 mL","Lack of Assurance of Sterility: The product lots are being recalled due to laboratory results (from a contract lab) indicating microbial contamination. The FDA was concerned test results obtained from the recalling firm's contract testing lab may not be reliable. Hence the sterility of the products cannot be assured. ",8/23/2013,"08/23/2013",9/25/2013,"09/25/2013"
"Drugs",66172,"Ongoing","Medaus, Inc.","Birmingham","AL","US","Voluntary: Firm Initiated","Telephone","Nationwide","D-1049-2013","Class II","Lipo-Injection w/ Lidocaine (PF), Ascorbic Acid 50 mg; B1-50 mg; B2-5-PO4-5 mg; B3-50 mg; B5-5 mg; B6-5 mg; Cyano B12-100 mcg; Methionine 12.5 mg; Inositol-25 mg; Choline-25 mg; Lidocaine 10 mg/mL, 30 mL, Medaus Pharmacy 1-800-526-9183","Lot #: 130510-26, Exp 11/16/2013; 130610-24, Exp 12/7/2013; and 130709-68, Exp 1/5/2014",,"19,803 mL","Lack of Assurance of Sterility: The product lots are being recalled due to laboratory results (from a contract lab) indicating microbial contamination. The FDA was concerned test results obtained from the recalling firm's contract testing lab may not be reliable. Hence the sterility of the products cannot be assured.",8/23/2013,"08/23/2013",9/25/2013,"09/25/2013"
"Drugs",66172,"Ongoing","Medaus, Inc.","Birmingham","AL","US","Voluntary: Firm Initiated","Telephone","Nationwide","D-1054-2013","Class II","NA Ascorbate 500 mg/mL, PF, 100 mL, Medaus Pharmacy 1-800-526-9183","LOT # 130702-1, Exp 12/29/2013 ",,"15,500 mL","Lack of Assurance of Sterility: The product lots are being recalled due to laboratory results (from a contract lab) indicating microbial contamination. The FDA was concerned test results obtained from the recalling firm's contract testing lab may not be reliable. Hence the sterility of the products cannot be assured. ",8/23/2013,"08/23/2013",9/25/2013,"09/25/2013"
"Drugs",66172,"Ongoing","Medaus, Inc.","Birmingham","AL","US","Voluntary: Firm Initiated","Telephone","Nationwide","D-1051-2013","Class II","L-Glutathione 200 mg/mL PF, 100 mL, Medaus Pharmacy 1-800-526-9183","LOT # 130617-10, Exp 12/14/2013",,"6130 mL","Lack of Assurance of Sterility: The product lots are being recalled due to laboratory results (from a contract lab) indicating microbial contamination. The FDA was concerned test results obtained from the recalling firm's contract testing lab may not be reliable. Hence the sterility of the products cannot be assured. ",8/23/2013,"08/23/2013",9/25/2013,"09/25/2013"
"Devices",66173,"Ongoing","Ormco/Sybronendo","Glendora","CA","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution - USA (nationwide) including the countries of Canada, Australia, New Zealand, EU and ROW consignees.","Z-2194-2013","Class II","Brand Name: Vector TAS 8mm Screw. The Device Listing Number is E670535. Vector T AS 8mm Screw is intended to provide a fixed anchorage point for attachment of orthodontic appliances to facilitate the orthodontic movement of teeth. It is used temporarily and removed after orthodontic treatment has been completed. It is surgically placed in the bone of the upper or lower jaw arches to provide support for orthodontic devices. ","Lot Number 112911: 8 MM Vector TAS Screw, Part Number 601-0021 Lot Number 112911: Vector TAS Starter Kit (10 Patient), Part Number 601-0010",".","4,786","Ormco Corporation is voluntarily recalling one lot of 8 MM Vector TAS Screws because some screws of this lot were machined undersized at the top of the threads may potentially cause a weakening of the screw. Use of the undersized product may result in breakage of the screw during insertion or removal when torqued, possibly requiring surgical removal of any remaining pieces.",7/12/2013,"07/12/2013",9/18/2013,"09/18/2013"
"Food",66174,"Ongoing","Snoqualmie Falls Candy Factory, LLC","Snoqualmie","WA","US","Voluntary: Firm Initiated","Visit","distributed in WA.","F-1951-2013","Class II","Almond Brittle's label is read in parts:''***ALMOND BRITTLE***INGREDIENTS: Sugar, corn syrup, almonds, brown sugar, butter (cream, salt), baking soda, salt. NO PRESERVATIVES ADDED***Net Wt. 8 oz.***www.snofallscandy.com***Toll Free 1-888-636-CANDY***''.","firm did not provide",".","Unknown","Finished product labels declared butter or cream but milk is not listed.",8/27/2013,"08/27/2013",10/2/2013,"10/02/2013"
"Food",66174,"Ongoing","Snoqualmie Falls Candy Factory, LLC","Snoqualmie","WA","US","Voluntary: Firm Initiated","Visit","distributed in WA.","F-1953-2013","Class II","Coconut Brittle's is labeled in parts: ''***COCONUT BRITTLE***INGREDIENTS: Coconut (preserved with metabisulfate), white sugar, glucose, butter (cream, salt), vanilla, salt***''.","firm did not provide",".","Unknown","Finished product labels declared butter or cream but milk is not listed.",8/27/2013,"08/27/2013",10/2/2013,"10/02/2013"
"Food",66174,"Ongoing","Snoqualmie Falls Candy Factory, LLC","Snoqualmie","WA","US","Voluntary: Firm Initiated","Visit","distributed in WA.","F-1952-2013","Class II","Coconut Peanut Brittle's label is read in parts:''***COCONUT PEANUT BRITTLE***INGREDIENTS: Coconut (preserved with sodium metabisulfate), peanuts, white sugar, glucose, water, butter (cream, salt), vanilla, salt***Net Wt. 8 oz.***www.snofallscandy.com***Toll Free 1-888-636-CANDY***''.","firm did not provide",".","Unknown","Finished product labels declared butter or cream but milk is not listed.",8/27/2013,"08/27/2013",10/2/2013,"10/02/2013"
"Food",66174,"Ongoing","Snoqualmie Falls Candy Factory, LLC","Snoqualmie","WA","US","Voluntary: Firm Initiated","Visit","distributed in WA.","F-1950-2013","Class II","Pecan Brittle's label is read in parts: ''***PECAN BRITTLE***INGREDIENTS: Sugar, corn syrup, pecans, brown sugar, butter (cream, salt), baking soda, salt. NO PRESERVATIVES ADDED***Net Wt. 8 oz.***www.snofallscandy.com***Toll Free 1-888-636-CANDY***''.","firm did not provide",".","Unknown","Finished product labels declared butter or cream but milk is not listed.",8/27/2013,"08/27/2013",10/2/2013,"10/02/2013"
"Food",66175,"Ongoing","Chobani Idaho","Twin Falls","ID","US","Voluntary: Firm Initiated","Press Release","distributed nationwide","F-0034-2014","Class II","12/6 oz. Chobani 0% Non-Fat Greek Yogurt Peach Fruit on the Bottom, UPC 8-94700-01006-9; 6/6 oz. Chobani 0% Non-Fat Greek Yogurt Peach on the Bottom-6 Value Pack, UPC 8-94700-01030-4; 6/4/6 oz. Chobani 0% Non-Fat Greek Yogurt Peach on the Bottom-4 Value Pack, UPC 8-18290-01284-5 ","Sep 11-13 (four didit time stamp) to Oct 07-13 (four digit time stamp) 16-012. This code is interpreted as Best By dates September 11, 2013 through October 07, 2013; 16-012 is the IMS number of a production plant in Twin Falls, Idaho. ",".","92,036 cases","Greek yogurt product Chobani brand is recalled due to report of illnesses and product bloated and swollen.",9/5/2013,"09/05/2013",10/30/2013,"10/30/2013"
"Food",66175,"Ongoing","Chobani Idaho","Twin Falls","ID","US","Voluntary: Firm Initiated","Press Release","distributed nationwide","F-0048-2014","Class II","12/6 oz. Chobani 0% Non-Fat Greek Yogurt Apple Cinnamon Fruit on the Bottom, UPC 8-94700-01017-5 ","Sep 11-13 (four didit time stamp) to Oct 07-13 (four digit time stamp) 16-012. This code is interpreted as Best By dates September 11, 2013 through October 07, 2013; 16-012 is the IMS number of a production plant in Twin Falls, Idaho. ",".","24,225 cases","Greek yogurt product Chobani brand is recalled due to report of illnesses and product bloated and swollen.",9/5/2013,"09/05/2013",10/30/2013,"10/30/2013"
"Food",66175,"Ongoing","Chobani Idaho","Twin Falls","ID","US","Voluntary: Firm Initiated","Press Release","distributed nationwide","F-0041-2014","Class II","6/4/3.5 oz. Chobani Bite 2% Milkfat Low-Fat Greek Yogurt Caramel w/ Pineapple Chunks-Bite, UPC 8-18290-01211-1 ","Sep 11-13 (four didit time stamp) to Oct 07-13 (four digit time stamp) 16-012. This code is interpreted as Best By dates September 11, 2013 through October 07, 2013; 16-012 is the IMS number of a production plant in Twin Falls, Idaho. ",".","24,406 cases","Greek yogurt product Chobani Bite brand is recalled due to report of illnesses and product bloated and swollen.",9/5/2013,"09/05/2013",10/30/2013,"10/30/2013"
"Food",66175,"Ongoing","Chobani Idaho","Twin Falls","ID","US","Voluntary: Firm Initiated","Press Release","distributed nationwide","F-0071-2014","Class II","Chobani Champions tubes, 2.25 oz., are sold in packages of 8, 16, or 36 counts per packages. 8/8/2.25 oz. Champions 1.5% Milkfat Low-Fat Greek Yogurt Chillin Cherry-Tubes, UPC 8-18290-01206-7 ","Sep 11-13 (four didit time stamp) to Oct 07-13 (four digit time stamp) 16-012. This code is interpreted as Best By dates September 11, 2013 through October 07, 2013; 16-012 is the IMS number of a production plant in Twin Falls, Idaho. ",".","5,040 cases","Greek yogurt product Chobani Champions brand is recalled due to report of illnesses and product bloated and swollen.",9/5/2013,"09/05/2013",10/30/2013,"10/30/2013"
"Food",66175,"Ongoing","Chobani Idaho","Twin Falls","ID","US","Voluntary: Firm Initiated","Press Release","distributed nationwide","F-0018-2014","Class II","12/6 oz. Chobani 0% Non-Fat Greek Yogurt Honey Blended, UPC 8-94700-01003-8 ","Sep 11-13 (four didit time stamp) to Oct 07-13 (four digit time stamp) 16-012. This code is interpreted as Best By dates September 11, 2013 through October 07, 2013; 16-012 is the IMS number of a production plant in Twin Falls, Idaho. ",".","unknown cases","Greek yogurt product Chobani brand is recalled due to report of illnesses and product bloated and swollen.",9/5/2013,"09/05/2013",10/30/2013,"10/30/2013"
"Food",66175,"Ongoing","Chobani Idaho","Twin Falls","ID","US","Voluntary: Firm Initiated","Press Release","distributed nationwide","F-0015-2014","Class II","The Chobani Flip products come in 5.3oz (150g) square plastic containers with a foil lid. There are 12 containers per pack. Chobani 0% Non-Fat Greek Yogurt Vanilla Golden Crunch-Flip, UPC 8-18290-01229-6 ","Sep 11-13 (four didit time stamp) to Oct 07-13 (four digit time stamp) 16-012. This code is interpreted as Best By dates September 11, 2013 through October 07, 2013; 16-012 is the IMS number of a production plant in Twin Falls, Idaho. ",".","21,229 cases","Greek yogurt product Chobani brand is recalled due to report of illnesses and product bloated and swollen.",9/5/2013,"09/05/2013",10/30/2013,"10/30/2013"
"Food",66175,"Ongoing","Chobani Idaho","Twin Falls","ID","US","Voluntary: Firm Initiated","Press Release","distributed nationwide","F-0025-2014","Class II","3/8/3.5 oz. Chobani 0% Non-Fat Greek Yogurt Strawberry & Peach Blended-8 Value Pack, UPC 8-18290-01287-6 ","Sep 11-13 (four didit time stamp) to Oct 07-13 (four digit time stamp) 16-012. This code is interpreted as Best By dates September 11, 2013 through October 07, 2013; 16-012 is the IMS number of a production plant in Twin Falls, Idaho. ",".","13,992 cases","Greek yogurt product Chobani brand is recalled due to report of illnesses and product bloated and swollen.",9/5/2013,"09/05/2013",10/30/2013,"10/30/2013"
"Food",66175,"Ongoing","Chobani Idaho","Twin Falls","ID","US","Voluntary: Firm Initiated","Press Release","distributed nationwide","F-0055-2014","Class II","6/4/3.5 oz. Chobani Bite 2% Milkfat Low-Fat Greek Yogurt Fig with Orange Zest, UPC 8-18290-01210-4 ","Sep 11-13 (four didit time stamp) to Oct 07-13 (four digit time stamp) 16-012. This code is interpreted as Best By dates September 11, 2013 through October 07, 2013; 16-012 is the IMS number of a production plant in Twin Falls, Idaho. ",".","3,384 cases","Greek yogurt product Chobani Bite brand is recalled due to report of illnesses and product bloated and swollen.",9/5/2013,"09/05/2013",10/30/2013,"10/30/2013"
"Food",66175,"Ongoing","Chobani Idaho","Twin Falls","ID","US","Voluntary: Firm Initiated","Press Release","distributed nationwide","F-0051-2014","Class II","3/8/3.5 oz. Chobani 2% Milkfat Low-Fat Greek Yogurt Mango & Pineapple Blended-8 Value Pack, UPC 8-18290-01290-6 ","Sep 11-13 (four didit time stamp) to Oct 07-13 (four digit time stamp) 16-012. This code is interpreted as Best By dates September 11, 2013 through October 07, 2013; 16-012 is the IMS number of a production plant in Twin Falls, Idaho. ",".","5,009 cases","Greek yogurt product Chobani brand is recalled due to report of illnesses and product bloated and swollen.",9/5/2013,"09/05/2013",10/30/2013,"10/30/2013"
"Food",66175,"Ongoing","Chobani Idaho","Twin Falls","ID","US","Voluntary: Firm Initiated","Press Release","distributed nationwide","F-0040-2014","Class II","6/16 oz. Chobani 2% Milkfat Low-Fat Greek Yogurt Pineapple Blended, UPC 8-94700-01046-5 ","Sep 11-13 (four didit time stamp) to Oct 07-13 (four digit time stamp) 16-012. This code is interpreted as Best By dates September 11, 2013 through October 07, 2013; 16-012 is the IMS number of a production plant in Twin Falls, Idaho. ",".","1,756 cases","Greek yogurt product Chobani brand is recalled due to report of illnesses and product bloated and swollen.",9/5/2013,"09/05/2013",10/30/2013,"10/30/2013"
"Food",66175,"Ongoing","Chobani Idaho","Twin Falls","ID","US","Voluntary: Firm Initiated","Press Release","distributed nationwide","F-0075-2014","Class II","The Chobani Flip product come in 5.3oz (150g) square plastic containers with a foil lid. There are 12 containers per pack. Chobani 1.5% Milkfat Low-Fat Greek Yogurt Nutty for Nana-Flip, UPC 8-18290-01260-9 ","Sep 11-13 (four didit time stamp) to Oct 07-13 (four digit time stamp) 16-012. This code is interpreted as Best By dates September 11, 2013 through October 07, 2013; 16-012 is the IMS number of a production plant in Twin Falls, Idaho. ",".","28,920 cases","Greek yogurt product Chobani brand is recalled due to report of illnesses and product bloated and swollen.",9/5/2013,"09/05/2013",10/30/2013,"10/30/2013"
"Food",66175,"Ongoing","Chobani Idaho","Twin Falls","ID","US","Voluntary: Firm Initiated","Press Release","distributed nationwide","F-0020-2014","Class II","12/6 oz. Chobani 0% Non-Fat Greek Yogurt Strawberry Fruit on the Bottom, UPC 8-94700-01004-5; 6/6 oz. Chobani 0% Non-Fat Greek Yogurt Strawberry on the Bottom-6 Value Pack, UPC 8-94700-01040-3; 6/4/6 oz. Chobani 0% Non-Fat Greek Yogurt Strawberry on the Bottom-4 Value Pack, UPC 8-18290-01281-4 ","Sep 11-13 (four didit time stamp) to Oct 07-13 (four digit time stamp) 16-012. This code is interpreted as Best By dates September 11, 2013 through October 07, 2013; 16-012 is the IMS number of a production plant in Twin Falls, Idaho. ",".","114,965 cases","Greek yogurt product Chobani brand is recalled due to report of illnesses and product bloated and swollen.",9/5/2013,"09/05/2013",10/30/2013,"10/30/2013"
"Food",66175,"Ongoing","Chobani Idaho","Twin Falls","ID","US","Voluntary: Firm Initiated","Press Release","distributed nationwide","F-0070-2014","Class II","Chobani Champions tubes, 2.25 oz., are sold in packages of 8, 16, or 36 counts per packages: 8/8/2.25 oz. Champions 1.5% Milkfat Low-Fat Greek Yogurt Flyin Dragon Fruit-Tubes, UPC 8-18290-01265-4 Chobani Champions product also comes in 3.5 oz. plastic cups: 6/4/3.5 oz. Champions 1.5% Milkfat Low-Fat Greek Yogurt Dragon Fruit, UPC 8-18290-01264-7; ","Sep 11-13 (four didit time stamp) to Oct 07-13 (four digit time stamp) 16-012. This code is interpreted as Best By dates September 11, 2013 through October 07, 2013; 16-012 is the IMS number of a production plant in Twin Falls, Idaho. ",".","2,433 (3.5 oz) cases; 7,335 (2.25 oz) cases","Greek yogurt product Chobani Champions brand is recalled due to report of illnesses and product bloated and swollen.",9/5/2013,"09/05/2013",10/30/2013,"10/30/2013"
"Food",66175,"Ongoing","Chobani Idaho","Twin Falls","ID","US","Voluntary: Firm Initiated","Press Release","distributed nationwide","F-0027-2014","Class II","Chobani Champions tubes, 2.25 oz., are sold in packages of 8, 16, or 36 counts per packages: 8/8/2.25 oz. Champions 1.5% Milkfat Low-Fat Greek Yogurt Jammin Strawberry-Tubes, UPC 8-18290-01204-3 ","Sep 11-13 (four didit time stamp) to Oct 07-13 (four digit time stamp) 16-012. This code is interpreted as Best By dates September 11, 2013 through October 07, 2013; 16-012 is the IMS number of a production plant in Twin Falls, Idaho. ",".","43,415 cases","Greek yogurt product Chobani Champions brand is recalled due to report of illnesses and product bloated and swollen.",9/5/2013,"09/05/2013",10/30/2013,"10/30/2013"
"Food",66175,"Ongoing","Chobani Idaho","Twin Falls","ID","US","Voluntary: Firm Initiated","Press Release","distributed nationwide","F-0060-2014","Class II","12/6 oz. Chobani 0% Non-Fat Greek Yogurt Blackberry Fruit on the Bottom, UPC 8-18290-01259-3; 6/4/6 oz. Chobani 0% Non-Fat Greek Yogurt Blackberry on the Bottom-4 Value Pack, UPC 8-18290-01286-9 ","Sep 11-13 (four didit time stamp) to Oct 07-13 (four digit time stamp) 16-012. This code is interpreted as Best By dates September 11, 2013 through October 07, 2013; 16-012 is the IMS number of a production plant in Twin Falls, Idaho. ",".","9,079 cases","Greek yogurt product Chobani brand is recalled due to report of illnesses and product bloated and swollen.",9/5/2013,"09/05/2013",10/30/2013,"10/30/2013"
"Food",66175,"Ongoing","Chobani Idaho","Twin Falls","ID","US","Voluntary: Firm Initiated","Press Release","distributed nationwide","F-0046-2014","Class II","12/6 oz. Chobani 0% Non-Fat Greek Yogurt Black Cherry Fruit on the Bottom, UPC 8-94700-01016-8; 6/6 oz. Chobani 0% Non-Fat Greek Yogurt Black Cherry on the Bottom-6 Value Pack, UPC 8-94700-01039-7; 6/4/6 oz. Chobani 0% Non-Fat Greek Yogurt Black Cherry on the Bottom-4 Value Pack, UPC 8-18290-01283-8 ","Sep 11-13 (four didit time stamp) to Oct 07-13 (four digit time stamp) 16-012. This code is interpreted as Best By dates September 11, 2013 through October 07, 2013; 16-012 is the IMS number of a production plant in Twin Falls, Idaho. ",".","109,540 cases","Greek yogurt product Chobani brand is recalled due to report of illnesses and product bloated and swollen.",9/5/2013,"09/05/2013",10/30/2013,"10/30/2013"
"Food",66175,"Ongoing","Chobani Idaho","Twin Falls","ID","US","Voluntary: Firm Initiated","Press Release","distributed nationwide","F-0061-2014","Class II","3/8/3.5 oz. Chobani 0% Non-Fat Greek Yogurt Black Cherry & Blackberry Blended-8 Value Pack, UPC 8-18290-01289-0 ","Sep 11-13 (four didit time stamp) to Oct 07-13 (four digit time stamp) 16-012. This code is interpreted as Best By dates September 11, 2013 through October 07, 2013; 16-012 is the IMS number of a production plant in Twin Falls, Idaho. ",".","4,287 cases","Greek yogurt product Chobani brand is recalled due to report of illnesses and product bloated and swollen.",9/5/2013,"09/05/2013",10/30/2013,"10/30/2013"
"Food",66175,"Ongoing","Chobani Idaho","Twin Falls","ID","US","Voluntary: Firm Initiated","Press Release","distributed nationwide","F-0038-2014","Class II","12/6 oz. Chobani 0% Non-Fat Greek Yogurt Lemon Blended, UPC 8-94700-01009-0 ","Sep 11-13 (four didit time stamp) to Oct 07-13 (four digit time stamp) 16-012. This code is interpreted as Best By dates September 11, 2013 through October 07, 2013; 16-012 is the IMS number of a production plant in Twin Falls, Idaho. ",".","26,631 cases","Greek yogurt product Chobani brand is recalled due to report of illnesses and product bloated and swollen.",9/5/2013,"09/05/2013",10/30/2013,"10/30/2013"
"Food",66175,"Ongoing","Chobani Idaho","Twin Falls","ID","US","Voluntary: Firm Initiated","Press Release","distributed nationwide","F-0029-2014","Class II","The Chobani Flip product come in 5.3oz (150g) square plastic containers with a foil lid. There are 12 containers per pack. Chobani 0% Non-Fat Greek Yogurt Strawberry Sunrise-Flip, UPC 8-18290-01226-5 ","Sep 11-13 (four didit time stamp) to Oct 07-13 (four digit time stamp) 16-012. This code is interpreted as Best By dates September 11, 2013 through October 07, 2013; 16-012 is the IMS number of a production plant in Twin Falls, Idaho. ",".","39,289 cases","Greek yogurt product Chobani brand is recalled due to report of illnesses and product bloated and swollen.",9/5/2013,"09/05/2013",10/30/2013,"10/30/2013"
"Food",66175,"Ongoing","Chobani Idaho","Twin Falls","ID","US","Voluntary: Firm Initiated","Press Release","distributed nationwide","F-0023-2014","Class II","12/6 oz. Chobani 2% Milkfat Low-Fat Greek Yogurt Strawberry Banana Blended, UPC 8-94700-01032-8; 6/4/6 oz. Chobani 2% Milkfat Low-Fat Greek Yogurt Strawberry Banana Blended, UPC 8-18290-01280-7 ","Sep 11-13 (four didit time stamp) to Oct 07-13 (four digit time stamp) 16-012. This code is interpreted as Best By dates September 11, 2013 through October 07, 2013; 16-012 is the IMS number of a production plant in Twin Falls, Idaho. ",".","74,295 cases","Greek yogurt product Chobani brand is recalled due to report of illnesses and product bloated and swollen.",9/5/2013,"09/05/2013",10/30/2013,"10/30/2013"
"Food",66175,"Ongoing","Chobani Idaho","Twin Falls","ID","US","Voluntary: Firm Initiated","Press Release","distributed nationwide","F-0017-2014","Class II","6/4/3.5 oz. Champions 1.5% Milkfat Low-Fat Greek Yogurt Vanilla Chocolate Chunk, UPC 8-94700-01048-9 ","Sep 11-13 (four didit time stamp) to Oct 07-13 (four digit time stamp) 16-012. This code is interpreted as Best By dates September 11, 2013 through October 07, 2013; 16-012 is the IMS number of a production plant in Twin Falls, Idaho. ",".","6,783 cases","Greek yogurt product Chobani brand is recalled due to report of illnesses and product bloated and swollen.",9/5/2013,"09/05/2013",10/30/2013,"10/30/2013"
"Food",66175,"Ongoing","Chobani Idaho","Twin Falls","ID","US","Voluntary: Firm Initiated","Press Release","distributed nationwide","F-0049-2014","Class II","12/6 oz. Chobani 2% Milkfat Low-Fat Greek Yogurt Mango Fruit on the Bottom, UPC 8-94700-01033-5 ","Sep 11-13 (four didit time stamp) to Oct 07-13 (four digit time stamp) 16-012. This code is interpreted as Best By dates September 11, 2013 through October 07, 2013; 16-012 is the IMS number of a production plant in Twin Falls, Idaho. ",".","58,188 cases","Greek yogurt product Chobani brand is recalled due to report of illnesses and product bloated and swollen.",9/5/2013,"09/05/2013",10/30/2013,"10/30/2013"
"Food",66175,"Ongoing","Chobani Idaho","Twin Falls","ID","US","Voluntary: Firm Initiated","Press Release","distributed nationwide","F-0065-2014","Class II","6/4/3.5 oz. Chobani Bite 0% Non-Fat Greek Yogurt Raspberry with Dark Chocolate Chips, UPC 8-18290-01208-1 ","Sep 11-13 (four didit time stamp) to Oct 07-13 (four digit time stamp) 16-012. This code is interpreted as Best By dates September 11, 2013 through October 07, 2013; 16-012 is the IMS number of a production plant in Twin Falls, Idaho. ",".","72,476 cases","Greek yogurt product Chobani Bite brand is recalled due to report of illnesses and product bloated and swollen.",9/5/2013,"09/05/2013",10/30/2013,"10/30/2013"
"Food",66175,"Ongoing","Chobani Idaho","Twin Falls","ID","US","Voluntary: Firm Initiated","Press Release","distributed nationwide","F-0045-2014","Class II","12/6 oz. Chobani 0% Non-Fat Greek Yogurt Pomegranate Fruit on the Bottom, UPC 8-94700-01015-1 ","Sep 11-13 (four didit time stamp) to Oct 07-13 (four digit time stamp) 16-012. This code is interpreted as Best By dates September 11, 2013 through October 07, 2013; 16-012 is the IMS number of a production plant in Twin Falls, Idaho. ",".","63,493 cases","Greek yogurt product Chobani brand is recalled due to report of illnesses and product bloated and swollen.",9/5/2013,"09/05/2013",10/30/2013,"10/30/2013"
"Food",66175,"Ongoing","Chobani Idaho","Twin Falls","ID","US","Voluntary: Firm Initiated","Press Release","distributed nationwide","F-0039-2014","Class II","12/6 oz. Chobani 2% Milkfat Low-Fat Greek Yogurt Pineapple Fruit on the Bottom, 8-94700-01010-6; 6/6 oz. Chobani 2% Milkfat Low-Fat Greek Yogurt Pineapple on the Bottom-6 Value Pack, 8-94700-01038-0; 6/4/6 oz. Chobani 2% Milkfat Low-Fat Greek Yogurt Pineapple on the Bottom-4 Value Pack, 8-18290-01285-2 ","Sep 11-13 (four didit time stamp) to Oct 07-13 (four digit time stamp) 16-012. This code is interpreted as Best By dates September 11, 2013 through October 07, 2013; 16-012 is the IMS number of a production plant in Twin Falls, Idaho. ",".","75,902 cases","Greek yogurt product Chobani brand is recalled due to report of illnesses and product bloated and swollen.",9/5/2013,"09/05/2013",10/30/2013,"10/30/2013"
"Food",66175,"Ongoing","Chobani Idaho","Twin Falls","ID","US","Voluntary: Firm Initiated","Press Release","distributed nationwide","F-0052-2014","Class II","12/6 oz. Chobani 0% Non-Fat Greek Yogurt Blood Orange Fruit on the Bottom, UPC 8-94700-01034-2 ","Sep 11-13 (four didit time stamp) to Oct 07-13 (four digit time stamp) 16-012. This code is interpreted as Best By dates September 11, 2013 through October 07, 2013; 16-012 is the IMS number of a production plant in Twin Falls, Idaho. ",".","36,232 cases","Greek yogurt product Chobani brand is recalled due to report of illnesses and product bloated and swollen.",9/5/2013,"09/05/2013",10/30/2013,"10/30/2013"
"Food",66175,"Ongoing","Chobani Idaho","Twin Falls","ID","US","Voluntary: Firm Initiated","Press Release","distributed nationwide","F-0022-2014","Class II","6/4/3.5 oz. Champions 1.5% Milkfat Low-Fat Greek Yogurt Strawberry, UPC 8-18290-01261-6 ","Sep 11-13 (four didit time stamp) to Oct 07-13 (four digit time stamp) 16-012. This code is interpreted as Best By dates September 11, 2013 through October 07, 2013; 16-012 is the IMS number of a production plant in Twin Falls, Idaho. ",".","4,428 cases","Greek yogurt product Chobani brand is recalled due to report of illnesses and product bloated and swollen.",9/5/2013,"09/05/2013",10/30/2013,"10/30/2013"
"Food",66175,"Ongoing","Chobani Idaho","Twin Falls","ID","US","Voluntary: Firm Initiated","Press Release","distributed nationwide","F-0028-2014","Class II","Chobani Champions tubes, 2.25 oz., are sold in packages of 8, 16, or 36 counts per packages: 6/36/2.25 oz. Champions 1.5% Milkfat Low-Fat Greek Yogurt Rockin Blueberry & Jammin Strawberry-Tubes Variety Pack, UPC 8-18290-01230-2 6/16/2.25 oz. Champions 1.5% Milkfat Low-Fat Greek Yogurt Rockin Blueberry & Jammin Strawberry-Tubes, UPC 8-18290-01225-8; ","Sep 11-13 (four didit time stamp) to Oct 07-13 (four digit time stamp) 16-012. This code is interpreted as Best By dates September 11, 2013 through October 07, 2013; 16-012 is the IMS number of a production plant in Twin Falls, Idaho. ",".","28,513 cases","Greek yogurt product Chobani Champions brand is recalled due to report of illnesses and product bloated and swollen.",9/5/2013,"09/05/2013",10/30/2013,"10/30/2013"
"Food",66175,"Ongoing","Chobani Idaho","Twin Falls","ID","US","Voluntary: Firm Initiated","Press Release","distributed nationwide","F-0044-2014","Class II","6/4/6 oz. Chobani 0% Non-Fat Greek Yogurt Raspberry Blended-4 Value Pack, UPC 8-18290-01276-0 ","Sep 11-13 (four didit time stamp) to Oct 07-13 (four digit time stamp) 16-012. This code is interpreted as Best By dates September 11, 2013 through October 07, 2013; 16-012 is the IMS number of a production plant in Twin Falls, Idaho. ",".","10,454 cases","Greek yogurt product Chobani brand is recalled due to report of illnesses and product bloated and swollen.",9/5/2013,"09/05/2013",10/30/2013,"10/30/2013"
"Food",66175,"Ongoing","Chobani Idaho","Twin Falls","ID","US","Voluntary: Firm Initiated","Press Release","distributed nationwide","F-0021-2014","Class II","6/32 oz. Chobani 0% Non-Fat Greek Yogurt Strawberry Blended, UPC 8-94700-01026-7 ","Sep 11-13 (four didit time stamp) to Oct 07-13 (four digit time stamp) 16-012. This code is interpreted as Best By dates September 11, 2013 through October 07, 2013; 16-012 is the IMS number of a production plant in Twin Falls, Idaho. ",".","15,076 cases","Greek yogurt product Chobani brand is recalled due to report of illnesses and product bloated and swollen.",9/5/2013,"09/05/2013",10/30/2013,"10/30/2013"
"Food",66175,"Ongoing","Chobani Idaho","Twin Falls","ID","US","Voluntary: Firm Initiated","Press Release","distributed nationwide","F-0066-2014","Class II","6/4/3.5 oz. Chobani Bite 0% Non-Fat Greek Yogurt Coffee with Dark Chocolate Chips-Bite, UPC 8-18290-01209-8 ","Sep 11-13 (four didit time stamp) to Oct 07-13 (four digit time stamp) 16-012. This code is interpreted as Best By dates September 11, 2013 through October 07, 2013; 16-012 is the IMS number of a production plant in Twin Falls, Idaho. ",".","43,916 cases","Greek yogurt product Chobani Bite brand is recalled due to report of illnesses and product bloated and swollen.",9/5/2013,"09/05/2013",10/30/2013,"10/30/2013"
"Food",66175,"Ongoing","Chobani Idaho","Twin Falls","ID","US","Voluntary: Firm Initiated","Press Release","distributed nationwide","F-0033-2014","Class II","The Chobani Flip product come in 5.3oz (150g) square plastic containers with a foil lid. There are 12 containers per pack. Chobani 0% Non-Fat Greek Yogurt Blueberry Power-Flip, UPC 8-18290-01247-0 ","Sep 11-13 (four didit time stamp) to Oct 07-13 (four digit time stamp) 16-012. This code is interpreted as Best By dates September 11, 2013 through October 07, 2013; 16-012 is the IMS number of a production plant in Twin Falls, Idaho. ",".","33,957 cases","Greek yogurt product Chobani brand is recalled due to report of illnesses and product bloated and swollen.",9/5/2013,"09/05/2013",10/30/2013,"10/30/2013"
"Food",66175,"Ongoing","Chobani Idaho","Twin Falls","ID","US","Voluntary: Firm Initiated","Press Release","distributed nationwide","F-0068-2014","Class II","6/4/3.5 oz. Champions 1.5% Milkfat Low-Fat Greek Yogurt Very Berry, UPC 8-94700-01049-6 ","Sep 11-13 (four didit time stamp) to Oct 07-13 (four digit time stamp) 16-012. This code is interpreted as Best By dates September 11, 2013 through October 07, 2013; 16-012 is the IMS number of a production plant in Twin Falls, Idaho. ",".","28,828 cases","Greek yogurt product Chobani brand is recalled due to report of illnesses and product bloated and swollen.",9/5/2013,"09/05/2013",10/30/2013,"10/30/2013"
"Food",66175,"Ongoing","Chobani Idaho","Twin Falls","ID","US","Voluntary: Firm Initiated","Press Release","distributed nationwide","F-0053-2014","Class II","6/4/3.5 oz. Champions 1.5% Milkfat Low-Fat Greek Yogurt Orange Vanilla, UPC 8-94700-01058-8 ","Sep 11-13 (four didit time stamp) to Oct 07-13 (four digit time stamp) 16-012. This code is interpreted as Best By dates September 11, 2013 through October 07, 2013; 16-012 is the IMS number of a production plant in Twin Falls, Idaho. ",".","629 cases","Greek yogurt product Chobani brand is recalled due to report of illnesses and product bloated and swollen.",9/5/2013,"09/05/2013",10/30/2013,"10/30/2013"
"Food",66175,"Ongoing","Chobani Idaho","Twin Falls","ID","US","Voluntary: Firm Initiated","Press Release","distributed nationwide","F-0058-2014","Class II","12/6 oz. Chobani 0% Non-Fat Greek Yogurt Pear Fruit on the Bottom, UPC 8-18290-01202-9 ","Sep 11-13 (four didit time stamp) to Oct 07-13 (four digit time stamp) 16-012. This code is interpreted as Best By dates September 11, 2013 through October 07, 2013; 16-012 is the IMS number of a production plant in Twin Falls, Idaho. ",".","10,668 cases","Greek yogurt product Chobani brand is recalled due to report of illnesses and product bloated and swollen.",9/5/2013,"09/05/2013",10/30/2013,"10/30/2013"
"Food",66175,"Ongoing","Chobani Idaho","Twin Falls","ID","US","Voluntary: Firm Initiated","Press Release","distributed nationwide","F-0013-2014","Class II","12/6 oz. Chobani 2% Milkfat Low-Fat Greek Yogurt Plain, UPC 8-94700-01031-1; 6/16 oz. Chobani 2% Milkfat Low-Fat Greek Yogurt Plain, UPC 8-94700-01037-3; 6/32 oz. Chobani 2% Milkfat Low-Fat Greek Yogurt Plain, UPC 8-94700-01043-4 ","Sep 11-13 (four didit time stamp) to Oct 07-13 (four digit time stamp) 16-012. This code is interpreted as Best By dates September 11, 2013 through October 07, 2013; 16-012 is the IMS number of a production plant in Twin Falls, Idaho.",".","1,954 (6 oz) cases; (16 oz) unknown cases; (32 oz) unknown cases","Greek yogurt product Chobani brand is recalled due to report of illnesses and product bloated and swollen.",9/5/2013,"09/05/2013",10/30/2013,"10/30/2013"
"Food",66175,"Ongoing","Chobani Idaho","Twin Falls","ID","US","Voluntary: Firm Initiated","Press Release","distributed nationwide","F-0047-2014","Class II","6/16 oz. Chobani 0% Non-Fat Greek Yogurt Black Cherry Blended, UPC 8-94700-01056-4 ","Sep 11-13 (four didit time stamp) to Oct 07-13 (four digit time stamp) 16-012. This code is interpreted as Best By dates September 11, 2013 through October 07, 2013; 16-012 is the IMS number of a production plant in Twin Falls, Idaho. ",".","1,224 cases","Greek yogurt product Chobani brand is recalled due to report of illnesses and product bloated and swollen.",9/5/2013,"09/05/2013",10/30/2013,"10/30/2013"
"Food",66175,"Ongoing","Chobani Idaho","Twin Falls","ID","US","Voluntary: Firm Initiated","Press Release","distributed nationwide","F-0043-2014","Class II","12/6 oz. Chobani 0% Non-Fat Greek Yogurt Raspberry Fruit on the Bottom, UPC 8-94700-01012-0 ","Sep 11-13 (four didit time stamp) to Oct 07-13 (four digit time stamp) 16-012. This code is interpreted as Best By dates September 11, 2013 through October 07, 2013; 16-012 is the IMS number of a production plant in Twin Falls, Idaho. ",".","88,528 cases","Greek yogurt product Chobani brand is recalled due to report of illnesses and product bloated and swollen.",9/5/2013,"09/05/2013",10/30/2013,"10/30/2013"
"Food",66175,"Ongoing","Chobani Idaho","Twin Falls","ID","US","Voluntary: Firm Initiated","Press Release","distributed nationwide","F-0067-2014","Class II","6/4/3.5 oz. Chobani Bite 0% Non-Fat Greek Yogurt Mint with Dark Chocolate Chips-Bite, UPC 8-18290-01293-7 ","Sep 11-13 (four didit time stamp) to Oct 07-13 (four digit time stamp) 16-012. This code is interpreted as Best By dates September 11, 2013 through October 07, 2013; 16-012 is the IMS number of a production plant in Twin Falls, Idaho. ",".","7,060 cases","Greek yogurt product Chobani Bite brand is recalled due to report of illnesses and product bloated and swollen.",9/5/2013,"09/05/2013",10/30/2013,"10/30/2013"
"Food",66175,"Ongoing","Chobani Idaho","Twin Falls","ID","US","Voluntary: Firm Initiated","Press Release","distributed nationwide","F-0059-2014","Class II","12/6 oz. Chobani 2% Milkfat Low-Fat Greek Yogurt Apricot Fruit on the Bottom, UPC 8-18290-01258-6 ","Sep 11-13 (four didit time stamp) to Oct 07-13 (four digit time stamp) 16-012. This code is interpreted as Best By dates September 11, 2013 through October 07, 2013; 16-012 is the IMS number of a production plant in Twin Falls, Idaho. ",".","4,191 cases","Greek yogurt product Chobani brand is recalled due to report of illnesses and product bloated and swollen.",9/5/2013,"09/05/2013",10/30/2013,"10/30/2013"
"Food",66175,"Ongoing","Chobani Idaho","Twin Falls","ID","US","Voluntary: Firm Initiated","Press Release","distributed nationwide","F-0056-2014","Class II","12/6 oz. Chobani 2% Milkfat Low-Fat Greek Yogurt Banana Fruit on the Bottom, UPC 8-94700-01044-1 ","Sep 11-13 (four didit time stamp) to Oct 07-13 (four digit time stamp) 16-012. This code is interpreted as Best By dates September 11, 2013 through October 07, 2013; 16-012 is the IMS number of a production plant in Twin Falls, Idaho. ",".","21,432 cases","Greek yogurt product Chobani brand is recalled due to report of illnesses and product bloated and swollen.",9/5/2013,"09/05/2013",10/30/2013,"10/30/2013"
"Food",66175,"Ongoing","Chobani Idaho","Twin Falls","ID","US","Voluntary: Firm Initiated","Press Release","distributed nationwide","F-0072-2014","Class II","Chobani Champions tubes, 2.25 oz., are sold in packages of 8, 16, or 36 counts per packages. 16/2.25 oz. Chobani Champions Tubes -1.5% Milkfat Low-Fat Greek Yogurt Chillin Cherry & Swirlin Strawberry Banana-Tubes Variety Pack, UPC 8-18290-01240-1 ","Sep 11-13 (four didit time stamp) to Oct 07-13 (four digit time stamp) 16-012. This code is interpreted as Best By dates September 11, 2013 through October 07, 2013; 16-012 is the IMS number of a production plant in Twin Falls, Idaho. ",".","1,245 cases","Greek yogurt product Chobani Champtions brand is recalled due to report of illnesses and product bloated and swollen.",9/5/2013,"09/05/2013",10/30/2013,"10/30/2013"
"Food",66175,"Ongoing","Chobani Idaho","Twin Falls","ID","US","Voluntary: Firm Initiated","Press Release","distributed nationwide","F-0069-2014","Class II","4/4/3.5 oz. Champions 2% Milkfat Low-Fat Greek Yogurt Banana Honey & Very Berry-16 Variety Pack, UPC 8-94700-10102-6 ","Sep 11-13 (four didit time stamp) to Oct 07-13 (four digit time stamp) 16-012. This code is interpreted as Best By dates September 11, 2013 through October 07, 2013; 16-012 is the IMS number of a production plant in Twin Falls, Idaho. ",".","17,107 cases","Greek yogurt product Chobani brand is recalled due to report of illnesses and product bloated and swollen.",9/5/2013,"09/05/2013",10/30/2013,"10/30/2013"
"Food",66175,"Ongoing","Chobani Idaho","Twin Falls","ID","US","Voluntary: Firm Initiated","Press Release","distributed nationwide","F-0016-2014","Class II","6/16 oz. Chobani 2% Milkfat Low-Fat Greek Yogurt Vanilla Chocolate Chunk Blended, UPC 8-94700-01045-8 ","Sep 11-13 (four didit time stamp) to Oct 07-13 (four digit time stamp) 16-012. This code is interpreted as Best By dates September 11, 2013 through October 07, 2013; 16-012 is the IMS number of a production plant in Twin Falls, Idaho. ",".","5,496 cases","Greek yogurt product Chobani brand is recalled due to report of illnesses and product bloated and swollen.",9/5/2013,"09/05/2013",10/30/2013,"10/30/2013"
"Food",66175,"Ongoing","Chobani Idaho","Twin Falls","ID","US","Voluntary: Firm Initiated","Press Release","distributed nationwide","F-0063-2014","Class II","The Chobani Flip product come in 5.3oz (150g) square plastic containers with a foil lid. There are 12 containers per pack. Chobani 1.5% Milkfat Low-Fat Greek Yogurt Key Lime Crumble-Flip, UPC 8-18290-01227-2 ","Sep 11-13 (four didit time stamp) to Oct 07-13 (four digit time stamp) 16-012. This code is interpreted as Best By dates September 11, 2013 through October 07, 2013; 16-012 is the IMS number of a production plant in Twin Falls, Idaho. ",".","149,023 cases","Greek yogurt product Chobani brand is recalled due to report of illnesses and product bloated and swollen.",9/5/2013,"09/05/2013",10/30/2013,"10/30/2013"
"Food",66175,"Ongoing","Chobani Idaho","Twin Falls","ID","US","Voluntary: Firm Initiated","Press Release","distributed nationwide","F-0074-2014","Class II","The Chobani Flip product come in 5.3oz (150g) square plastic containers with a foil lid. There are 12 containers per pack. Chobani 1.5% Milkfat Low-Fat Greek Yogurt Tropical Escape-Flip, UPC 8-18290-01249-4 ","Sep 11-13 (four didit time stamp) to Oct 07-13 (four digit time stamp) 16-012. This code is interpreted as Best By dates September 11, 2013 through October 07, 2013; 16-012 is the IMS number of a production plant in Twin Falls, Idaho. ",".","25,833 cases","Greek yogurt product Chobani brand is recalled due to report of illnesses and product bloated and swollen.",9/5/2013,"09/05/2013",10/30/2013,"10/30/2013"
"Food",66175,"Ongoing","Chobani Idaho","Twin Falls","ID","US","Voluntary: Firm Initiated","Press Release","distributed nationwide","F-0024-2014","Class II","8/8/2.25 oz. Champions 1.5% Milkfat Low-Fat Greek Yogurt Swirlin Strawberry Banana-Tubes, 8-18290-01207-4 ","Sep 11-13 (four didit time stamp) to Oct 07-13 (four digit time stamp) 16-012. This code is interpreted as Best By dates September 11, 2013 through October 07, 2013; 16-012 is the IMS number of a production plant in Twin Falls, Idaho. ",".","8,687 cases","Greek yogurt product Chobani brand is recalled due to report of illnesses and product bloated and swollen.",9/5/2013,"09/05/2013",10/30/2013,"10/30/2013"
"Food",66175,"Ongoing","Chobani Idaho","Twin Falls","ID","US","Voluntary: Firm Initiated","Press Release","distributed nationwide","F-0035-2014","Class II","6/16 oz. Chobani 0% Non-Fat Greek Yogurt Peach Blended, UPC 8-94700-01029-8 ","Sep 11-13 (four didit time stamp) to Oct 07-13 (four digit time stamp) 16-012. This code is interpreted as Best By dates September 11, 2013 through October 07, 2013; 16-012 is the IMS number of a production plant in Twin Falls, Idaho. ",".","1,331 cases","Greek yogurt product Chobani brand is recalled due to report of illnesses and product bloated and swollen.",9/5/2013,"09/05/2013",10/30/2013,"10/30/2013"
"Food",66175,"Ongoing","Chobani Idaho","Twin Falls","ID","US","Voluntary: Firm Initiated","Press Release","distributed nationwide","F-0037-2014","Class II","15/6 oz. Chobani 0% Non-Fat Greek Yogurt, BB, Straw, Peach Fruit on the Bottom-15 Variety Pack, UPC 8-18290-01216-6 ","Sep 11-13 (four didit time stamp) to Oct 07-13 (four digit time stamp) 16-012. This code is interpreted as Best By dates September 11, 2013 through October 07, 2013; 16-012 is the IMS number of a production plant in Twin Falls, Idaho. ",".","86,974 cases","Greek yogurt product Chobani brand is recalled due to report of illnesses and product bloated and swollen.",9/5/2013,"09/05/2013",10/30/2013,"10/30/2013"
"Food",66175,"Ongoing","Chobani Idaho","Twin Falls","ID","US","Voluntary: Firm Initiated","Press Release","distributed nationwide","F-0057-2014","Class II","6/4/3.5 oz. Champions 1.5% Milkfat Low-Fat Greek Yogurt Banana Honey, UPC 8-94700-01052-6 ","Sep 11-13 (four didit time stamp) to Oct 07-13 (four digit time stamp) 16-012. This code is interpreted as Best By dates September 11, 2013 through October 07, 2013; 16-012 is the IMS number of a production plant in Twin Falls, Idaho. ",".","1,680 cases","Greek yogurt product Chobani brand is recalled due to report of illnesses and product bloated and swollen.",9/5/2013,"09/05/2013",10/30/2013,"10/30/2013"
"Food",66175,"Ongoing","Chobani Idaho","Twin Falls","ID","US","Voluntary: Firm Initiated","Press Release","distributed nationwide","F-0036-2014","Class II","The Chobani Flip product come in 5.3oz (150g) square plastic containers with a foil lid. There are 12 containers per pack. Chobani 1.5% Milkfat Low-Fat Greek Yogurt Peachy Pistachio-Flip, UPC 8-18290-01248-7 ","Sep 11-13 (four didit time stamp) to Oct 07-13 (four digit time stamp) 16-012. This code is interpreted as Best By dates September 11, 2013 through October 07, 2013; 16-012 is the IMS number of a production plant in Twin Falls, Idaho. ",".","36,191 cases","Greek yogurt product Chobani brand is recalled due to report of illnesses and product bloated and swollen.",9/5/2013,"09/05/2013",10/30/2013,"10/30/2013"
"Food",66175,"Ongoing","Chobani Idaho","Twin Falls","ID","US","Voluntary: Firm Initiated","Press Release","distributed nationwide","F-0062-2014","Class II","12/6 oz. Chobani 2% Milkfat Low-Fat Greek Yogurt Key Lime Blended, UPC 8-18290-01271-5; 6/4/6 oz. Chobani 2% Milkfat Low-Fat Greek Yogurt Key Lime Blended-4 Value Pack, UPC 8-18290-01275-3 ","Sep 11-13 (four didit time stamp) to Oct 07-13 (four digit time stamp) 16-012. This code is interpreted as Best By dates September 11, 2013 through October 07, 2013; 16-012 is the IMS number of a production plant in Twin Falls, Idaho. ",".","56,578 cases","Greek yogurt product Chobani brand is recalled due to report of illnesses and product bloated and swollen.",9/5/2013,"09/05/2013",10/30/2013,"10/30/2013"
"Food",66175,"Ongoing","Chobani Idaho","Twin Falls","ID","US","Voluntary: Firm Initiated","Press Release","distributed nationwide","F-0031-2014","Class II","Chobani Champions tubes, 2.25 oz., are sold in packages of 8, 16, or 36 counts per packages: 6/4/3.5 oz. Champions 1.5% Milkfat Low-Fat Greek Yogurt Blueberry, UPC 8-18290-01262-3; Chobani Champions also comes in 3.5 oz plastic cups: 8/8/2.25 oz. Champions 1.5% Milkfat Low-Fat Greek Yogurt Rockin Blueberry-Tubes, UPC 8-18290-01205-0 ","Sep 11-13 (four didit time stamp) to Oct 07-13 (four digit time stamp) 16-012. This code is interpreted as Best By dates September 11, 2013 through October 07, 2013; 16-012 is the IMS number of a production plant in Twin Falls, Idaho. ",".","3,954 (3.5 oz) cases; 33,038 (2.25 oz) cases","Greek yogurt product Chobani Champions brand is recalled due to report of illnesses and product bloated and swollen.",9/5/2013,"09/05/2013",10/30/2013,"10/30/2013"
"Food",66175,"Ongoing","Chobani Idaho","Twin Falls","ID","US","Voluntary: Firm Initiated","Press Release","distributed nationwide","F-0050-2014","Class II","6/16 oz. Chobani 2% Milkfat Low-Fat Greek Yogurt Mango Blended, UPC 8-94700-01018-2 ","Sep 11-13 (four didit time stamp) to Oct 07-13 (four digit time stamp) 16-012. This code is interpreted as Best By dates September 11, 2013 through October 07, 2013; 16-012 is the IMS number of a production plant in Twin Falls, Idaho. ",".","640 cases","Greek yogurt product Chobani brand is recalled due to report of illnesses and product bloated and swollen.",9/5/2013,"09/05/2013",10/30/2013,"10/30/2013"
"Food",66175,"Ongoing","Chobani Idaho","Twin Falls","ID","US","Voluntary: Firm Initiated","Press Release","distributed nationwide","F-0014-2014","Class II","12/6 oz. Chobani 0% Non-Fat Greek Yogurt Vanilla Blended, UPC 8-94700-01002-1; 6/16 oz. Chobani 0% Non-Fat Greek Yogurt Vanilla Blended, UPC 8-94700-01008-3; 6/32 oz. Chobani 0% Non-Fat Greek Yogurt Vanilla Blended, UPC 8-94700-01014-4; 6/4/6 oz. Chobani 0% Non-Fat Greek Yogurt Vanilla Blended-4 Value Pack, UPC 8-18290-01279-1 ","Sep 11-13 (four didit time stamp) to Oct 07-13 (four digit time stamp) 16-012. This code is interpreted as Best By dates September 11, 2013 through October 07, 2013; 16-012 is the IMS number of a production plant in Twin Falls, Idaho. ",".","52,020 (6 oz) cases; 1,608 (16 oz) cases; 25,899 (32 oz) cases","Greek yogurt product Chobani brand is recalled due to report of illnesses and product bloated and swollen.",9/5/2013,"09/05/2013",10/30/2013,"10/30/2013"
"Food",66175,"Ongoing","Chobani Idaho","Twin Falls","ID","US","Voluntary: Firm Initiated","Press Release","distributed nationwide","F-0064-2014","Class II","12/6 oz. Chobani 2% Milkfat Low-Fat Greek Yogurt Coconut Blended, UPC 8-18290-01273-9 6/4/6 oz. Chobani 2% Milkfat Low-Fat Greek Yogurt Coconut Blended-4 Value pack, UPC 8-18290-01277-7 ","Sep 11-13 (four didit time stamp) to Oct 07-13 (four digit time stamp) 16-012. This code is interpreted as Best By dates September 11, 2013 through October 07, 2013; 16-012 is the IMS number of a production plant in Twin Falls, Idaho. ",".","47,630 cases","Greek yogurt product Chobani brand is recalled due to report of illnesses and product bloated and swollen.",9/5/2013,"09/05/2013",10/30/2013,"10/30/2013"
"Food",66175,"Ongoing","Chobani Idaho","Twin Falls","ID","US","Voluntary: Firm Initiated","Press Release","distributed nationwide","F-0019-2014","Class II","6/4/3.5 oz. Chobani Bite 2% Milkfat Greek Yogurt Honey With Ginger, UPC 8-18290-01213-5 ","Sep 11-13 (four didit time stamp) to Oct 07-13 (four digit time stamp) 16-012. This code is interpreted as Best By dates September 11, 2013 through October 07, 2013; 16-012 is the IMS number of a production plant in Twin Falls, Idaho. ",".","2,484 cases","Greek yogurt product Chobani Bite brand is recalled due to report of illnesses and product bloated and swollen.",9/5/2013,"09/05/2013",10/30/2013,"10/30/2013"
"Food",66175,"Ongoing","Chobani Idaho","Twin Falls","ID","US","Voluntary: Firm Initiated","Press Release","distributed nationwide","F-0073-2014","Class II","The Chobani Flip product come in 5.3oz (150g) square plastic containers with a foil lid. There are 12 containers per pack. Chobani 1.5% Milkfat Low-Fat Greek Yogurt Almond Coco Loco-Flip, UPC 8-18290-01228-9 ","Sep 11-13 (four didit time stamp) to Oct 07-13 (four digit time stamp) 16-012. This code is interpreted as Best By dates September 11, 2013 through October 07, 2013; 16-012 is the IMS number of a production plant in Twin Falls, Idaho. ",".","121,992 cases","Greek yogurt product Chobani brand is recalled due to report of illnesses and product bloated and swollen.",9/5/2013,"09/05/2013",10/30/2013,"10/30/2013"
"Food",66175,"Ongoing","Chobani Idaho","Twin Falls","ID","US","Voluntary: Firm Initiated","Press Release","distributed nationwide","F-0030-2014","Class II","12/6 oz. Chobani 0% Non-Fat Greek Yogurt Blueberry Fruit on the Bottom, UPC 8-94700-01005-2; 6/6 oz. Chobani 0% Non-Fat Greek Yogurt Blueberry Fruit on the Bottom-6 Value Pack, UPC 8-94700-01041-0; 6/4/6 oz. Chobani 0% Non-Fat Greek Yogurt Blueberry Fruit on the Bottom-4 Value Pack, UPC 8-18290-01282-1 ","Sep 11-13 (four didit time stamp) to Oct 07-13 (four digit time stamp) 16-012. This code is interpreted as Best By dates September 11, 2013 through October 07, 2013; 16-012 is the IMS number of a production plant in Twin Falls, Idaho. ",".","102,893 cases","Greek yogurt product Chobani brand is recalled due to report of illnesses and product bloated and swollen.",9/5/2013,"09/05/2013",10/30/2013,"10/30/2013"
"Food",66175,"Ongoing","Chobani Idaho","Twin Falls","ID","US","Voluntary: Firm Initiated","Press Release","distributed nationwide","F-0012-2014","Class II","12/6 oz. Chobani 0% Non-Fat Greek Yogurt Plain, UPC 8-94700-01001-4; 6/16 oz. Chobani 0% Non-Fat Greek Yogurt Plain, UPC 8-94700-01007-6; 6/32 oz. Chobani 0% Non-Fat Greek Yogurt Plain, UPC 8-94700-01013-7; 6/32 oz. Chobani 0% Non-Fat Greek Yogurt Plain-Club Pack, UPC 8-94700-10184-2 ","Sep 11-13 (four didit time stamp) to Oct 07-13 (four digit time stamp) 16-012. This code is interpreted as Best By dates September 11, 2013 through October 07, 2013; 16-012 is the IMS number of a production plant in Twin Falls, Idaho.",".","46,611 (6 oz) cases; 2,207 (16 oz) cases; 68,708 (32 oz) cases","Greek yogurt product Chobani brand is recalled due to report of illnesses and product bloated and swollen.",9/5/2013,"09/05/2013",10/30/2013,"10/30/2013"
"Food",66175,"Ongoing","Chobani Idaho","Twin Falls","ID","US","Voluntary: Firm Initiated","Press Release","distributed nationwide","F-0032-2014","Class II","6/16 oz. Chobani 0% Non-Fat Greek Yogurt Blueberry Blended, UPC 8-94700-01055-7 ","Sep 11-13 (four didit time stamp) to Oct 07-13 (four digit time stamp) 16-012. This code is interpreted as Best By dates September 11, 2013 through October 07, 2013; 16-012 is the IMS number of a production plant in Twin Falls, Idaho. ",".","2,448 cases","Greek yogurt product Chobani brand is recalled due to report of illnesses and product bloated and swollen.",9/5/2013,"09/05/2013",10/30/2013,"10/30/2013"
"Food",66175,"Ongoing","Chobani Idaho","Twin Falls","ID","US","Voluntary: Firm Initiated","Press Release","distributed nationwide","F-0026-2014","Class II","3/8/3.5 oz. Chobani 0% Non-Fat Greek Yogurt Strawberry & Blueberry Blended-8 Value Pack, UPC 8-18290-01288-3 ","Sep 11-13 (four didit time stamp) to Oct 07-13 (four digit time stamp) 16-012. This code is interpreted as Best By dates September 11, 2013 through October 07, 2013; 16-012 is the IMS number of a production plant in Twin Falls, Idaho. ",".","22,375 cases","Greek yogurt product Chobani brand is recalled due to report of illnesses and product bloated and swollen.",9/5/2013,"09/05/2013",10/30/2013,"10/30/2013"
"Food",66175,"Ongoing","Chobani Idaho","Twin Falls","ID","US","Voluntary: Firm Initiated","Press Release","distributed nationwide","F-0054-2014","Class II","12/6 oz. Chobani 2% Milkfat Low-Fat Greek Yogurt Orange Vanilla Blended, UPC 8-18290-01274-6; 6/4/6 oz. Chobani 2% Milkfat Low-Fat Greek Yogurt Orange Vanilla Blended-4 Value Pack, UPC 8-18290-01278-4 ","Sep 11-13 (four didit time stamp) to Oct 07-13 (four digit time stamp) 16-012. This code is interpreted as Best By dates September 11, 2013 through October 07, 2013; 16-012 is the IMS number of a production plant in Twin Falls, Idaho. ",".","21,992 cases","Greek yogurt product Chobani brand is recalled due to report of illnesses and product bloated and swollen.",9/5/2013,"09/05/2013",10/30/2013,"10/30/2013"
"Food",66175,"Ongoing","Chobani Idaho","Twin Falls","ID","US","Voluntary: Firm Initiated","Press Release","distributed nationwide","F-0042-2014","Class II","12/6 oz. Chobani 2% Milkfat Low-Fat Greek Yogurt Passion Fruit Fruit on the Bottom, UPC 8-94700-01011-3 ","Sep 11-13 (four didit time stamp) to Oct 07-13 (four digit time stamp) 16-012. This code is interpreted as Best By dates September 11, 2013 through October 07, 2013; 16-012 is the IMS number of a production plant in Twin Falls, Idaho. ",".","22,751 cases","Greek yogurt product Chobani brand is recalled due to report of illnesses and product bloated and swollen.",9/5/2013,"09/05/2013",10/30/2013,"10/30/2013"
"Devices",66176,"Ongoing","Zeppessis Reprocessing, LLC","Garden City","ID","US","Voluntary: Firm Initiated","Telephone","Distributed in the states of California, Idaho, Oregon, and Washington.","Z-2212-2013","Class II","Zeppessis' reprocessed single-use manifolds (filters) for the Stryker Neptune 1 and Neptune 2 Waste Management Systems: The Neptune Waste management system is intended to be used in the Operating Room, Surgical Centers and Doctor's Offices to collect and dispose of surgical fluid waste as well as collect smoke generated from electrocautory or laser devices. ***The single-port manifold for the Stryker Neptune 1 (part # 700-015-000) can be used with the: Neptune 1 Gold Rover or the Neptune Bronze Rover as an accessory to Class 2 Air-handling apparatus for a surgical operating room (Sec. 878.5070); or with the Neptune 1 Silver Rover as an accessory to Class 2 Powered suction pump. ***four-port manifold for the Stryker Neptune 1 (part # 700-020-000) can be used with the: Neptune 1 Gold Rover or the Neptune Bronze Rover as an accessory to Class 2 Air-handling apparatus for a surgical operating room (Sec. 878.5070); or with the Neptune 1 Silver Rover as an accessory to Class 2 Powered suction pump. ***single-port manifold for the Stryker Neptune 2 (part # 702-025-000) can be used with the Neptune 2 Rover Ultra as an accessory to Class 2 Powered suction pump. ***four-port manifold for the Stryker Neptune 2 (part # 702-020-000) can be used with the Neptune 2 Rover Ultra as an accessory to Class 2 Powered suction pump. ","-Single-port manifold for the Stryker Neptune 1 (part # 700-015-000); -Four-port manifold for the Stryker Neptune 1 (part # 700-020-000); -Single-port manifold for the Stryker Neptune 2 (part # 702-025-000); -Four-port manifold for the Stryker Neptune 2 (part # 702-020-000). ",,"undetermined the distributed amounts","Zeppessis' reprocessed single-use manifolds (filters) for the Stryker Neptune 1 and Neptune 2 Waste Management Systems are recalled due to lacking 510K and and without a validated cleaning protocol for reprocessing the used manifolds. ",8/16/2013,"08/16/2013",9/25/2013,"09/25/2013"
"Biologics",66178,"Terminated","American National Red Cross The","Pomona","CA","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","California","B-0015-14","Class II","Red Blood Cells Leukocytes Reduced","W20061303009800C is the Unit ",".","1","Blood product, manufactured from an overweight whole blood unit, was distributed.",7/23/2013,"07/23/2013",10/30/2013,"10/30/2013"
"Biologics",66179,"Terminated","Tacoma Pierce County Blood Bank","Tacoma","WA","US","Voluntary: Firm Initiated","Telephone","Washington; New Jersey; New York","B-0017-14","Class III","Red Blood Cells Leukocytes Reduced","W127813702233; W127813702234; W127813702236; W127813702215; W127813702216; W127813702217; W127813702219; W127813702223; W127813702224; W127813702225; W127813702226; W127813702228; W127813702231; W127813702209; W127813702211; W127813702202; W127813702203; W127813702204; W127813702205; W127813702206; W127813702207; W127813702208; W127813702242; ",".","23","Blood products, collected using equipment for which quality control was not performed, were distributed. ",8/1/2013,"08/01/2013",10/30/2013,"10/30/2013"
"Biologics",66179,"Terminated","Tacoma Pierce County Blood Bank","Tacoma","WA","US","Voluntary: Firm Initiated","Telephone","Washington; New Jersey; New York","B-0016-14","Class III","Red Blood Cells Leukocytes Reduced Irradiated","W127813702227; W127813702232; ",".","2","Blood products, collected using equipment for which quality control was not performed, were distributed. ",8/1/2013,"08/01/2013",10/30/2013,"10/30/2013"
"Biologics",66181,"Terminated","Community Blood Center Of Gtr KC","Kansas City","MO","US","Voluntary: Firm Initiated","FAX","Kansa, Missouri","B-0018-14","Class II","Platelets Pheresis Leukocytes Reduced","W045013900556; W045013904307; W045013900566; W045013904334; W045013905579; W045013900557; W045013900566; W045013904334; W045013900555; W045013904474; W045013904527; W045013905579; ",".","12","Blood products, for which the quality control testing was incomplete, were distributed.",7/26/2013,"07/26/2013",10/30/2013,"10/30/2013"
"Biologics",66182,"Terminated","LifeShare Blood Centers","Shreveport","LA","US","Voluntary: Firm Initiated","Letter","Louisiana","B-0014-14","Class II","Red Blood Cells Leukocytes Reduced","W036512156050; ",".","1 unit","Blood product, collected from a donor who visited a malarial endemic area, was distributed. ",5/3/2013,"05/03/2013",12/11/2013,"12/11/2013"
"Devices",66184,"Completed","King Systems Corp.","Noblesville","IN","US","Voluntary: Firm Initiated","Letter","Nationwide Distribution - NE only.","Z-2272-2013","Class I","Universal Flex2 Breathing Circuit Class I 510(k) Exempt An anesthesia breathing circuit is a device that is intended to administer medical gases to a patient during anesthesia. It provides both an inhalation and exhalation route and may include a connector, adaptor, and Y-piece.","Part Number DF4110-61 Lot Number I063N",,"1 case; 40 units","King Systems received a customer complaint indicating that the customer had ordered a breathing circuit with a Latex breathing bag. The product they received contained a Latex breathing bag, but was labeled as non-latex.",8/23/2012,"08/23/2012",10/9/2013,"10/09/2013"
"Devices",66185,"Ongoing","King Systems Corp.","Noblesville","IN","US","Voluntary: Firm Initiated","Telephone","Distributed in NY.","Z-2255-2013","Class III","King LT-D Oropharyngeal Airways Class 1, 510(k) exempt The King LT-D is intended for use in adult patients (in excess of 25 kg) for controlled ventilation during anesthesia for procedures that are short in duration and when the patient is considered to have a low risk of aspiration of stomach contents.","Part Number KLTD2125 Lot Number I10RG",,"9 cases; 45 products","King Systems is initiating a voluntary recall of an affected lot of its KLTD products shipped on April 30, 2013. King Systems has received a report that size 5 KLTD airways were packaged in pouches indicating a size of 2.5 and shipped to your facility. The correct size of the KLTD airway is clearly marked on the actual airway product and the physical size difference between 2.5 and 5 is distinct and obvious. King Systems has received no reports of serious injuries or deaths resulting from this issue.",9/3/2013,"09/03/2013",9/25/2013,"09/25/2013"
"Devices",66186,"Ongoing","Integra LifeSciences Corp. d.b.a. Integra Pain Management","Salt Lake City","UT","US","Voluntary: Firm Initiated","Letter","Nationwide Distribution including CA, CO, FL, IN, KS, NC, NV, NY, OK, TN, TX, VA, WA, and WI.","Z-2260-2013","Class II","Cranial Access (CRAK) Kits, Product / Catalogue No.s: INSHITH, INSHITHND, INSHITHRZN The kits allow for access to the subarachnoid space or the lateral ventricles of the brain. The kits are intended to be used with an external drainage and monitoring system in selected patients to reduce intracranial pressure (ICP), to monitor CSF, to provide temporary drainage of CSF, and to monitor ICP.","INSHITH Lots: W1205183,,W1207036,,W1209165,,W1209166,,W1209168,,W1210156,,W1210157,,W1210158,,W1210159,,W1210160,,W1211021,,W1211030,,W1211135,,W1211136,,W1211137,,W1212170 INSHITHND Lots: W1210230 INSHITHRZN Lots: W1209156,,W1211182,,W1212090,,W1212125,,W1212178,,W1301258,,W1302005,,W1302031,,W1303148 ",,"8,648","Integra is recalling certain lots of Cranial Access Kit due to a possibility that the seal integrity of the sterile package may become compromised during shipping. ",9/4/2013,"09/04/2013",9/25/2013,"09/25/2013"
"Food",66187,"Terminated","Mothers Milk Bank","San Jose","CA","US","Voluntary: Firm Initiated","Telephone","Product was distributed to 6 hospitals in Honolulu and California.","F-1949-2013","Class II","Human breast milk, pasteurized, 4 oz, in bottles; Pasteurized Human Milk,Hospital Grade Milk. Mother's Milk Bank 751 S. Bascom Abe.San Jose, CA 95128","Batch number SC1308067; 001-071, Expiry 2/2/14",".","70 x 4 oz. bottles","Human Breast milk was collected from a donor that tested reactive for Hepatitis B in a screening test.",8/20/2013,"08/20/2013",10/2/2013,"10/02/2013"
"Drugs",66188,"Ongoing","Wellness Pharmacy, Inc.","Birmingham","AL","US","Voluntary: Firm Initiated","Telephone","Nationwide and Puerto Rico","D-1034-2013","Class II","RL Glutathione 100 mg/mL, SDV PF,a) 1 mL, b) 2 mL, c) 3 mL, and d) 4 mL, WELLNESS PHARMACY, 1-800-227-2627","Lot# 130710@27, Use By: 1/6/2014",".","34 Vials","Lack of Assurance of Sterility: The product lots are being recalled due to laboratory results indicating microbial contamination. The FDA was concerned test results obtained from the recalling firm's contract testing lab may not be reliable.",8/23/2013,"08/23/2013",9/18/2013,"09/18/2013"
"Drugs",66188,"Ongoing","Wellness Pharmacy, Inc.","Birmingham","AL","US","Voluntary: Firm Initiated","Telephone","Nationwide and Puerto Rico","D-1035-2013","Class II","Dexpanthenol 250 mg/mL PF, Single Use Vial, 1 mL, WELLNESS PHARMACY, 1-800-227-2627","Lot# 130605@52, Exp. 12/2/13 ",".","1355 Vials","Lack of Assurance of Sterility: The product lots are being recalled due to laboratory results indicating microbial contamination. The FDA was concerned test results obtained from the recalling firm's contract testing lab may not be reliable.",8/23/2013,"08/23/2013",9/18/2013,"09/18/2013"
"Drugs",66188,"Ongoing","Wellness Pharmacy, Inc.","Birmingham","AL","US","Voluntary: Firm Initiated","Telephone","Nationwide and Puerto Rico","D-1030-2013","Class II","Dexpanthenol 250mg/ml PF, Qty: 1mL, WELLNESS PHARMACY, 1-800-227-2627","Lot# 130605@52, Exp. 12/2/2013",".","1355 units","The product lots are being recalled due to laboratory results indicating microbial contamination. The FDA was concerned test results obtained from the recalling firm's contract testing lab may not be reliable.",8/23/2013,"08/23/2013",9/18/2013,"09/18/2013"
"Drugs",66188,"Ongoing","Wellness Pharmacy, Inc.","Birmingham","AL","US","Voluntary: Firm Initiated","Telephone","Nationwide and Puerto Rico","D-1033-2013","Class II","NA. Phenylbutyrate 200 mg/mL, SDV, a) 10 mL, b) 25 mL, and c) 50 mL, WELLNESS PHARMACY, 1-800-227-2627","Lot# 130621@28, Use by: 10/19/2013",".","200 Vials","Lack of Assurance of Sterility: The product lots are being recalled due to laboratory results indicating microbial contamination. The FDA was concerned test results obtained from the recalling firm's contract testing lab may not be reliable.",8/23/2013,"08/23/2013",9/18/2013,"09/18/2013"
"Drugs",66188,"Ongoing","Wellness Pharmacy, Inc.","Birmingham","AL","US","Voluntary: Firm Initiated","Telephone","Nationwide and Puerto Rico","D-1032-2013","Class II","Methyl B12 1 mg/mL P.F., Single-Use Vial, a) 1 mL, b) 10 mL, WELLNESS PHARMACY, 1-800-227-2627","Lot# 130612@49, Use By: 12/9/2013",".","2687 Vials","Lack of Assurance of Sterility: The product lots are being recalled due to laboratory results indicating microbial contamination. The FDA was concerned test results obtained from the recalling firm's contract testing lab may not be reliable.",8/23/2013,"08/23/2013",9/18/2013,"09/18/2013"
"Drugs",66188,"Ongoing","Wellness Pharmacy, Inc.","Birmingham","AL","US","Voluntary: Firm Initiated","Telephone","Nationwide and Puerto Rico","D-1031-2013","Class II","Magnesium Sulfate Hepta 50% PF, Single Use Vial, a) 2 mL, b) 10 mL, WELLNESS PHARMACY, 1-800-227-2627","Lot# 130613@38, Use By: 12/10/2013",".","590 Vials","Lack of Assurance of Sterility: The product lots are being recalled due to laboratory results indicating microbial contamination. The FDA was concerned test results obtained from the recalling firm's contract testing lab may not be reliable.",8/23/2013,"08/23/2013",9/18/2013,"09/18/2013"
"Devices",66189,"Completed","King Systems Corp.","Noblesville","IN","US","Voluntary: Firm Initiated",,"USA Nationwide Distribution in the state of NY","Z-0002-2014","Class II","King LTS-D Oropharyngeal Airways Product Usage: The King LTS-D is intended for use in adult patients (in excess of 25 kg) for controlled ventilation during anesthesia for procedures that are short in duration and when the patient is considered to have a low risk of aspiration of stomach contents.","Part Number(s): KLTSD415 Lot Number(s): IV1V3",,"1 case; 5 units","On December 13, 2012, King Systems initiated a voluntary recall of one (1) case(s) (5) individual products) from one (1) lot [(IV1V3) 62 cases, 310 products]of King LTSD Oropharyngeal Airways because the package label indicated that the airway was a size 5 when in fact the airway in the package was a size 4. When King manufacturers a lot, all of the components are the same size, part number etc. In this instance, the lot number IV1V3 was for size 5 King LTSD airways, part number KLTSD415. The manufacturing and inventory records show that one case (5 products) of KLTSD size 4 airways were erroneously manufactured as part of lot IV1V3. King Systems has not received any further complaints.",12/13/2012,"12/13/2012",10/9/2013,"10/09/2013"
"Food",66190,"Ongoing","Cains Foods L.P.","Ayer","MA","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","AL, AZ, CA, CO, CT, FL, GA, IL, IN, KY, MA, MD, ME, MS, MT, NC, NH, NJ, NY, NM, OH, PA, RI, SC, TN, VA, WY","F-1892-2013","Class I","Olde Cape Cod Chipotle Ranch dressing, 16 oz. Item Number: 90997-11630","Best By date of Nov. 30, 2014 ",,"2,273 six-pack cases","Product may be labeled with an incorrect back panel label that does not declare the allergens milk and egg. ",9/5/2013,"09/05/2013",9/25/2013,"09/25/2013"
"Devices",66191,"Ongoing","Pinook-Usa","Orlando","FL","US","Voluntary: Firm Initiated","E-Mail","Worldwide Distribution-USA (nationwide) including Puerto Rico and Guam and the states of AZ, CA, CO, FL, IL, MA, MD, MO, MT, NC, ND, NJ, NV, NY, TX, VA, and WA and the country of Canada.","Z-0176-2014","Class II","Pinook Mini Massager Distributed by www.pinookusa.com. Used to strengthen the abdominal muscles. ","ALL LOTS",".","28,994 units (Mini and Micro)","Failure to submit a premarket submission and gain approval of a medical device.",5/23/2013,"05/23/2013",11/13/2013,"11/13/2013"
"Devices",66191,"Ongoing","Pinook-Usa","Orlando","FL","US","Voluntary: Firm Initiated","E-Mail","Worldwide Distribution-USA (nationwide) including Puerto Rico and Guam and the states of AZ, CA, CO, FL, IL, MA, MD, MO, MT, NC, ND, NJ, NV, NY, TX, VA, and WA and the country of Canada.","Z-0177-2014","Class II","Pinook Micro Massager Distributed by www.pinookusa.com Used to strengthen the abdominal muscles. ","ALL LOTS",".","28,994 units (Micro and Mini)","Failure to submit a premarket submission and gain approval of a medical device.",5/23/2013,"05/23/2013",11/13/2013,"11/13/2013"
"Biologics",66192,"Terminated","Arc Blood Services, New England Region","Dedham","MA","US","Voluntary: Firm Initiated","Telephone","New Hampshire; New York","B-0019-14","Class II","Platelets Pheresis Leukocytes Reduced","W200413816944P1; W200413816944P2; ",".","2","Blood products, for which the quality control testing was incomplete, were distributed.",7/16/2013,"07/16/2013",10/30/2013,"10/30/2013"
"Biologics",66193,"Terminated","DCI Biologicals LLC","Gallup","NM","US","Voluntary: Firm Initiated","FAX","United Kingdom","B-0020-14","Class II","Source Plasma","GA1515074; GA1515597; GA1517031; GA1517352; GA1518671; GA1519093; ",".","6","Blood products, which were not quarantined subsequent to receiving information regarding a post donation information, were distributed.",6/10/2013,"06/10/2013",10/30/2013,"10/30/2013"
"Biologics",66194,"Terminated","DCI Biologicals Orlando LLC","Jacksonville","FL","US","Voluntary: Firm Initiated","FAX","Pennsylvania","B-0021-14","Class II","Source Plasma","JV0116772; JV0117212; JV0118666; JV0119251; JV0119886; ",".","5","Blood products, which were not quarantined subsequent to receiving information regarding a post donation illness, were distributed.",6/21/2013,"06/21/2013",10/30/2013,"10/30/2013"
"Devices",66195,"Ongoing","Hologic, Inc.","Danbury","CT","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution - USA including the states of AL, AR, CA, CO, FL, IL, KY, LA, NE, NC, NJ, NY, OH, PA, TN, TX, UT, WA and WV., and the countries of Canada, Denmark, Iran, Italy, Mexico and Taiwan.","Z-2301-2013","Class II","Selenia Full Field Digital Mammography System with software versions 5.0.x and 5.1.x The Selenia Full Field Digital Mammography system generates digital mammography images that can be used for screening and diagnosis of breast cancer. The Selenia Full Field Digital Mammography System is intended for use in the same clinical applications as traditional screen-film mammography systems. Mammography images can be interpreted on either hard copy film or soft copy review workstations, cleared for mammography","Software versions 5.0.x and 5.1.x",,"62 systems","Software: When the Selenia upon meeting the hard drive threshold of 4,000 images, may delete the most recently dated images",9/6/2013,"09/06/2013",10/9/2013,"10/09/2013"
"Devices",66196,"Ongoing","Zimmer, Inc.","Warsaw","IN","US","Voluntary: Firm Initiated","Letter","International distribution: Japan only.","Z-0129-2014","Class II","Ti-Magna Fx Washer Ti-Versa-FXII Femoral Fixation System S/C Plates The compression tube/plates of this trauma system are used with Ti-Versa-Fx II Femoral Fixation System lag screws for the internal fixation of proximal femoral and supracondylar fractures. The Ti-Magna Fx System is an osteosynthesis item for orthopedic use in open internal fixation of fractures of the femoral neck, condyle, or tibia, etc. The washer prevents the screw head from being buried in the bone. ","00365888 00366414 60004449 60146383 60186345 60197210 60208698 60282431 60389889 60405108 60407931 60869220 61080693 61327948 61375455 61754656 61923922 60004450 60208699 60276711 60282432 60869221 61080694 61391007 60024174 61080695 61328382 61375457 61421602 24416600 60084846 60154683 60186372 60197211 60199098 60266079 60266080 60279692 60373565 60405109 60407932 60415506 60428806 60586953 60725599 61041311 61261269 61287734 61309831 61391008 61698392 61732770 61933545 60024175 60146386 60186373 60197212 60208702 61041313 61375459 61505519 61895287 62020570 60390423 60407933 60855531 60855535 60855536 60855537 61261270 23318000 23349600 60065066 60088732 60118716 60126399 60137449 60150012 60160727 60252568 60282398 60321685 60341615 60373346 60407903 60415261 60463630 60582482 60629012 60665668 60665669 60676030 60830532 60926411 60982760 61041155 61041156 61052948 61079688 61088994 61228687 61426136 61559639 61599273 61683731 61732260 61765106 61804102 61829985 61853628 61885960 61926992 61992671 62058073 62152073 62157809 ",".","2,632 devices","Zimmer recently conducted a review of historic packaging validations completed. Based on this review, it was determined that a subset of product packaged at a single Zimmer facility required testing to ensure that previously packaged product from this facility met the established requirements for sterile barrier integrity. The number of samples required for packaging testing, to provide statistical confidence (90% confidence in 99% reliability), were not available for the Ti MagnaFx Washer and Ti VersaFx S/C 90 degree and 95 degree plates. A voluntary recall will be conducted of all potentially affected products. The voluntary recall is limited to Japan as these products are distributed only in Japan",8/28/2013,"08/28/2013",11/13/2013,"11/13/2013"
"Drugs",66198,"Terminated","Northern New England Compounding Pharmacy LLC","Littleton","NH","US","Voluntary: Firm Initiated","Telephone","CT","D-1060-2013","Class II","Hydroxocobalamin MDV 5 mg/mL (5,000 mcg/mL) Inj., 10 mL vial X 3, Eastern States Compounding Pharmacy, Littleton, NH 03561","Lot #: 08022013@34, Exp11/3/2013",,"1 Vial","Lack of Assurance of Sterility: The pharmacy is recalling one lot of Hydroxocobalamin MDV 5mg/mL due to failed sterility results by a third party contract testing lab. Hence the sterility of the product cannot be assured. ",9/5/2013,"09/05/2013",9/25/2013,"09/25/2013"
"Devices",66199,"Ongoing","Zimmer, Inc.","Warsaw","IN","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Worldwide distribution: US (Nationwide) including Puerto Rico and Virgin Islands; and countries of: Australia, Algeria, Belgium, Bolivia, Canada, Canary Islands, Chile, Croatia, Finland, France, Germany, Greece, Guatemala, Honduras, India, Israel, Italy, Japan, Jordan, Lima-Peru, Malaysia, Morocco, Nicaragua, Portugal, Saudi Arabia, Seoul Korea, Serbia, Singapore, South Africa, Spain, Switzerland, Turkey, Utd.Arab.Emir., United Kingdom, and Venezuela.","Z-0277-2014","Class II","VerSys Cemented Revision Calcar (CRC) Hip System Femoral Stems VerSys Heritage Hip System Revision Femoral Stems. Indicated for total hip arthroplasty. ","00369673 00369898 00369984 00369985 00369988 00369989 00369995 00369996 00369997 00369998 00370074 00370082 00370103 00370161 00370162 00370163 00370165 00370166 00370240 00370241 00370242 00370244 00370245 00370246 00370285 00370299 00370300 00370301 00370371 00370374 00370376 00370377 00370378 00370379 00370382 00370405 00370406 00370407 00370409 00370411 00370417 00370428 00370471 00370475 00370620 00370621 00370906 60486158 60495799 60495801 60545572 60545573 60545574 60565682 60565683 60589392 60589393 60589394 60609870 60609871 60644570 60644588 60644589 60644590 60658265 60658266 60661955 60661956 60661957 60661958 60661959 60661960 60661962 60661964 60661965 60661966 60661968 60661971 60661974 60676452 60676454 60676455 60676456 60676457 60676459 60676460 60676462 60676463 60676464 60676467 60712462 60712463 60712464 60712465 60712468 60712469 60726764 60737992 60737996 60745879 60745880 60745885 60745886 60745887 60745893 60745898 60768909 60768910 60768911 60768912 60768913 60768914 60768915 60768916 60768917 60768918 60768919 60768921 60768925 60768926 60768927 60768928 60768929 60768930 60768931 60768932 60768933 60768934 60770498 60770499 60770501 60770502 60770505 60770513 60770514 60770519 60793095 60793096 60793097 60793098 60793099 60793101 60793102 60793103 60793104 60793105 60793106 60793107 60793161 60793162 60821283 60821284 60821285 60821287 60821288 60821289 60821290 60821291 60821292 60821293 60821294 60821295 60821296 60821297 60821298 60821299 60821301 60821302 60821303 60821304 60821305 60821306 60821307 60821308 60829409 60829410 60829412 60829413 60829414 60829415 60829418 60829425 60864596 60864597 60864598 60864599 60864601 60864602 60864603 60864604 60864605 60864606 60864607 60864608 60864609 60864610 60864611 60864612 60864619 60864620 60864621 60864622 60864623 60864624 60864625 60864628 60873796 60873797 60873798 60873799 60873801 60889514 60889515 60889516 60889533 60889534 60889535 60889536 60889537 60889538 60889539 60889540 60889541 60889542 60889543 60889544 60889545 60",".","12866 units","Based on a review of historic packaging validations, it was determined that a subset of product packaged in one of the clean rooms at a single Zimmer facility required testing to ensure that previously packaged product from this facility met the established requirements for sterile barrier integrity. The number of samples required for packaging testing (seal integrity and seal strength) to provide a 90% confidence and 99% reliability were not available for testing. As a result, Zimmer is recalling all lots of the product due to the potential that the sterile barrier integrity may be compromised. ",8/28/2013,"08/28/2013",11/20/2013,"11/20/2013"
"Drugs",66200,"Ongoing","Fallon Wellness Pharmacy Llc","Latham","NY","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","NY & ME","D-66200-001","Class II","Bevacizumab 25mg/mL, prepared as pre-filled syringes in 0.05 mL and 0.06 mL sizes, Fallon Wellness Pharmacy, Latham, NY 12110. ","Lot #: 08052013@84, Exp 11/5/2013",,"241 prefilled syringes","Lack of Assurance of Sterility: Fallon Pharmacy recalled Bevacizumab 25mg/mL due to sterility assurance concerns based on testing of this lot by a third party lab, indicating that test results reported as passing sterility may have been inaccurate.",9/5/2013,"09/05/2013",11/6/2013,"11/06/2013"
"Drugs",66200,"Ongoing","Fallon Wellness Pharmacy Llc","Latham","NY","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","NY & ME","D-66200-001","Class II","Bevacizumab 25mg/mL, prepared as pre-filled syringes in 0.05 mL and 0.06 mL sizes, Fallon Wellness Pharmacy, Latham, NY 12110. ","Lot #: 08052013@84, Exp 11/5/2013",,"241 prefilled syringes","Lack of Assurance of Sterility: Fallon Pharmacy recalled Bevacizumab 25mg/mL due to sterility assurance concerns based on testing of this lot by a third party lab, indicating that test results reported as passing sterility may have been inaccurate.",9/5/2013,"09/05/2013",11/6/2013,"11/06/2013"
"Drugs",66201,"Ongoing","Hospira Inc.","Lake Forest","IL","US","Voluntary: Firm Initiated","Letter","Nationwide","D-66201-001","Class II","5% Lidocaine HCl and 7.5% Dextrose Injection, USP, 2 mL Single Dose Ampuls, Rx only, Hospira, Inc., Lake Forest, IL 60045, NDC 0409-4712-01","Lot 23-227-DK",,"86,400 ampuls","Presence of Particulate Matter; report of glass particles in the ampule after dilution",8/29/2013,"08/29/2013",10/9/2013,"10/09/2013"
"Devices",66204,"Ongoing","Biomet 3i, LLC","Palm Beach Gardens","FL","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Worldwide Distribution - USA Nationwide in the states of MA, CT, NJ, DE, NY, FL, OK, TX, PA, DC, IL, KS, LA, MD, CA, RI, TN, MN, and SC and the countries of Canada, Japan, Australia, Italy Germany, France, Switzerland, Apain, Brazil, Uruguay, Singapore, Dominican Republic, Taiwan, Austria, Portugal, and the United Kingdom.","Z-2207-2013","Class II","Osseotite 2 Certain Prevail 5mm(D)X 4.1mm (P) X X 11.5mm (L) Dental Implant Product Usage: Surgical placement in the upper or lower jaw to provide a means for prosthetic attachment in single tooth restorations and in partially or fully edentulous spans with multiple single teeth utilizing delayed or immediate loading or with a terminal or intermediary abutment for fixed or removable bridgework and to retain over dentures.","XIIOS5411",,"215","One of the dental implants do not have the internal hex feature. One of the dental implants do not have the internal thread feature.",6/10/2013,"06/10/2013",9/25/2013,"09/25/2013"
"Devices",66204,"Ongoing","Biomet 3i, LLC","Palm Beach Gardens","FL","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Worldwide Distribution - USA Nationwide in the states of MA, CT, NJ, DE, NY, FL, OK, TX, PA, DC, IL, KS, LA, MD, CA, RI, TN, MN, and SC and the countries of Canada, Japan, Australia, Italy Germany, France, Switzerland, Apain, Brazil, Uruguay, Singapore, Dominican Republic, Taiwan, Austria, Portugal, and the United Kingdom.","Z-2208-2013","Class II","Osseotite Parallel Walled Certain 4mm(D)X 15mm (L) Dental Implant Product Usage: Surgical placement in the upper or lower jaw to provide a means for prosthetic attachment in single tooth restorations and in partially or fully edentulous spans with multiple single teeth utilizing delayed or immediate loading or with a terminal or intermediary abutment for fixed or removable bridgework and to retain over dentures.","IOSS415",,"178","One of the dental implants do not have the internal hex feature. One of the dental implants do not have the internal thread feature.",6/10/2013,"06/10/2013",9/25/2013,"09/25/2013"
"Devices",66205,"Ongoing","Philips Medical Systems (Cleveland) Inc","Cleveland","OH","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution - US (nationwide) including the states of NY, OH and Pa, and the countries of Australia, Austria, Egypt, France, Germany, India and Netherlands.","Z-0067-2014","Class II","Ingenuity TF PET/CT Diagnostic imaging system for fixed or mobile installations that combines Positron Emission Tomography (PET) and X-Ray Computed Tomography (CT) systems. The CT subsystem produces cross sectional images of the body by computer reconstruction of x-ray transmission data. The PET subsystem produces images of the distribution of PET radiopharmaceuticals in the patient body (specific radiopharmaceuticals are used for whole body, brain, heart and other Oran imaging). Attenuation correction is accomplished by CTAC. The device also provides for list mode, dynamic, and gated acquisitions. Image processing and display workstations provide software applications to process, analyze, display, quantify and interpret medical images/data. The PET and CT images may be registered and displayed in a ''fused'' (overlaid in the same spatial orientation) format to provide combined metabolic and anatomical data at different angles. Trained professionals use the images in: The evaluation, detection and diagnosis of lesions, disease and organ function such as but not limited to cancer, cardiovascular disease, and neurological disorders The detection, localization, and staging of tumors and diagnosing cancer patients. Treatment planning and interventional radiology procedures. The device includes software that provides a quantified analysis of regional cerebral activity from PET images. Cardiac imaging software provides functionality for quantification of cardiology images and data sets including but not limited to myocardial perfusion for the display of wall motion and quantification ventricular or left-function parameters from gated myocardial perfusion studies and for the 3D alignment of coronary artery images from CT coronary angiography onto the myocardium. Both subsystems (PET and CT) can also be operated. ","Model # 882456; Serial Number: 2003 -2013 and 2015 - 2019. ",,"13","Issues with the Ingenuity TF PET/CT Software Version 4.0 could pose a risk for patients in the event that a patient rescan were to require reinjection of PET radiopharmaceutical. ",8/16/2013,"08/16/2013",11/6/2013,"11/06/2013"
"Devices",66205,"Ongoing","Philips Medical Systems (Cleveland) Inc","Cleveland","OH","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution - US (nationwide) including the states of NY, OH and Pa, and the countries of Australia, Austria, Egypt, France, Germany, India and Netherlands.","Z-0067-2014","Class II","Ingenuity TF PET/CT Diagnostic imaging system for fixed or mobile installations that combines Positron Emission Tomography (PET) and X-Ray Computed Tomography (CT) systems. The CT subsystem produces cross sectional images of the body by computer reconstruction of x-ray transmission data. The PET subsystem produces images of the distribution of PET radiopharmaceuticals in the patient body (specific radiopharmaceuticals are used for whole body, brain, heart and other Oran imaging). Attenuation correction is accomplished by CTAC. The device also provides for list mode, dynamic, and gated acquisitions. Image processing and display workstations provide software applications to process, analyze, display, quantify and interpret medical images/data. The PET and CT images may be registered and displayed in a ''fused'' (overlaid in the same spatial orientation) format to provide combined metabolic and anatomical data at different angles. Trained professionals use the images in: The evaluation, detection and diagnosis of lesions, disease and organ function such as but not limited to cancer, cardiovascular disease, and neurological disorders The detection, localization, and staging of tumors and diagnosing cancer patients. Treatment planning and interventional radiology procedures. The device includes software that provides a quantified analysis of regional cerebral activity from PET images. Cardiac imaging software provides functionality for quantification of cardiology images and data sets including but not limited to myocardial perfusion for the display of wall motion and quantification ventricular or left-function parameters from gated myocardial perfusion studies and for the 3D alignment of coronary artery images from CT coronary angiography onto the myocardium. Both subsystems (PET and CT) can also be operated. ","Model # 882456; Serial Number: 2003 -2013 and 2015 - 2019. ",,"13","Issues with the Ingenuity TF PET/CT Software Version 4.0 could pose a risk for patients in the event that a patient rescan were to require reinjection of PET radiopharmaceutical. ",8/16/2013,"08/16/2013",11/6/2013,"11/06/2013"
"Drugs",66206,"Ongoing","University Compounding Pharmacy","San Diego","CA","US","Voluntary: Firm Initiated","Press Release","Nationwide","D-1023-2013","Class II","PGE-1, 20 mcg/mL Injection in Normal Saline, 10 mL, University Compounding Pharmacy, 855-398-1800.","Lot #: 497940, Exp 9/6/2013 ",".","85 mL","Lack of Assurance of Sterility: University Compounding Pharmacy is voluntarily recalling certain pharmacy products due to lack of assurance of sterility concerns.",9/6/2013,"09/06/2013",9/18/2013,"09/18/2013"
"Drugs",66206,"Ongoing","University Compounding Pharmacy","San Diego","CA","US","Voluntary: Firm Initiated","Press Release","Nationwide","D-1021-2013","Class II","Testosterone CYP (Sesame Oil) 200mg/mL Injection, 10 mL Vial, University Compounding Pharmacy, 855-398-1800. ","Lot #s: 474323, Exp 9/13/2013; 498616, Exp 9/25/2013; 475475, Exp 9/26/2013.",".","965.50 mL","Lack of Assurance of Sterility: University Compounding Pharmacy is voluntarily recalling certain pharmacy products due to lack of assurance of sterility concerns.",9/6/2013,"09/06/2013",9/18/2013,"09/18/2013"
"Drugs",66206,"Ongoing","University Compounding Pharmacy","San Diego","CA","US","Voluntary: Firm Initiated","Press Release","Nationwide","D-1020-2013","Class II","Testosterone Cypionate (Sesame Oil) 200mg/mL Injection, 10 mL Vial, University Compounding Pharmacy, 855-398-1800. ","Lot 511017, Exp 11/30/2013",".","178.2 mL","Lack of Assurance of Sterility: University Compounding Pharmacy is voluntarily recalling certain pharmacy products due to lack of assurance of sterility concerns.",9/6/2013,"09/06/2013",9/18/2013,"09/18/2013"
"Drugs",66206,"Ongoing","University Compounding Pharmacy","San Diego","CA","US","Voluntary: Firm Initiated","Press Release","Nationwide","D-1024-2013","Class II","PGE-1, 100 mcg/mL Injection in Normal Saline, 50 mL, University Compounding Pharmacy, 855-398-1800.","Lot #: 497930, 11/5/2013",".","37.805 mL","Lack of Assurance of Sterility: University Compounding Pharmacy is voluntarily recalling certain pharmacy products due to lack of assurance of sterility concerns.",9/6/2013,"09/06/2013",9/18/2013,"09/18/2013"
"Drugs",66206,"Ongoing","University Compounding Pharmacy","San Diego","CA","US","Voluntary: Firm Initiated","Press Release","Nationwide","D-1022-2013","Class II","Testosterone Cypionate/Testosterone Propionate 180-20 mg/mL Injection, 10 mL Vial, University Compounding Pharmacy, 855-398-1800. ","Lot 513593, Exp11/30/2013",".","70 mL","Lack of Assurance of Sterility: University Compounding Pharmacy is voluntarily recalling certain pharmacy products due to lack of assurance of sterility concerns.",9/6/2013,"09/06/2013",9/18/2013,"09/18/2013"
"Drugs",66207,"Ongoing","Hi-Tech Pharmacal Co., Inc.","Amityville","NY","US","Voluntary: Firm Initiated","Letter","Puerto Rico","D-66207-001","Class III","GILTUSS ANTITUSSIVE EXPECTORANT AND NASAL DECONGESTANT, 1 fl. oz. (NDC 58552-122-01) and 8 fl. oz. (NDC 58552-122-08), and EXACTUSS ANTITUSSIVE EXPECTORANT AND NASAL DECONGESTANT, 16 fl. oz. (NDC 58552-125-16) --- Manufactured for: GIL PHARMACEUTICAL CORP. PONCE, PUERTO RICO 00716","1 fl. oz. and 8 fl. oz.: Batch/Lot 615688 (exp. 06/2014) and Batch/Lot 617689 (exp. 11/2014); 16 fl. oz: Batch/Lot 615649 (exp. 05/2014).","."," 50,848 bottles (total for 3 lots)","Subpotent; phenylephrine HCl",9/4/2013,"09/04/2013",10/30/2013,"10/30/2013"
"Devices",66208,"Ongoing","Implantech Associates Inc","Ventura","CA","US","Voluntary: Firm Initiated","Letter","Worldwide distribution: US (nationwide) including states of NY, KY, and CO, and the country of Israel.","Z-2211-2013","Class II","Device Name: Terino Square Chin-Style II-Medium; Catalog Number: TSCII-M. To augment or reconstruct underdeveloped or traumatized mandibular region. ","Catalog Number: TSCII-M Lot Numbers: 848488 and 850156 ",,"8","Implantech initiated a voluntary recall of certain lots of Terino Square Chin-Style II-Medicum (Lot # 848488 and 850156), after determining that the devices from the lot numbers do not conform to the dimensional requirements for the TSCII-M. ",8/30/2013,"08/30/2013",9/25/2013,"09/25/2013"
"Devices",66209,"Ongoing","Horiba Instruments, Inc dba Horiba Medical","Irvine","CA","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution - USA including the country of Canada.","Z-2280-2013","Class III","ABX PENTRA Calcium CP Reagent, Model # A11A01633 Calcium plays an essential role in many cell functions: intracellularly in muscle contraction and glycogen metabolism, extracellularly, in bone mineralization, in blood coagulation and in transmission of nerve impulses. Calcium is present in plasma in three forms: free, bound to proteins or complexed with anions as phosphate, citrate and bicarbonate. Under physiological conditions, calcium balance is determined by the relationship between calcium intake and calcium absorption and excretion. Urinary excretion is an important determinant of calcium retention in the body. Decreased total calcium levels can be associated with diseases of the bone apparatus (especially osteoporosis), kidney diseases (especially under dialysis), defective intestinal absorption and hypoparathyroidism. Increased total calcium can be measured in hyperparathyroidism, malignant diseases with metastases and sarcoidosis. Calcium measurements also help in monitoring of calcium supplementation mainly in the prevention of osteoporosis. ","Lot/Serial #(s): 014664503",".","2,658 units ( 1240 US 1418 OUS )","HORIBA Medical is informing all PENTRA 200 and PENTRA 400 customers of a potential for reporting incorrect calcium results when using the ABX PENTRA CALCIUM CP reagent. ",9/6/2013,"09/06/2013",10/2/2013,"10/02/2013"
"Drugs",66210,"Ongoing","Avella of Deer Valley, Inc.","Phoenix","AZ","US","Voluntary: Firm Initiated","Press Release","Nationwide and Puerto Rico","D-1059-2013","Class II","Vancomycin PF (BSS) 1%, 1 mL, Avella Specialty Pharmacy, Phoenix, AZ 85085, 877-782-7684","12-20130508@181, Exp 10/4/2013",,"250 units","Lack of Assurance of Sterility: Avella Specialty Pharmacy is recalling bevacizumab and vancomycin due to concerns of sterility assurance with the specialty pharmacy's independent testing laboratory.",9/9/2013,"09/09/2013",9/25/2013,"09/25/2013"
"Drugs",66210,"Ongoing","Avella of Deer Valley, Inc.","Phoenix","AZ","US","Voluntary: Firm Initiated","Press Release","Nationwide and Puerto Rico","D-1058-2013","Class II","Bevacizumab 1.25 mg/0.05 mL PF, Avella Specialty Pharmacy, Phoenix, AZ, 85085, 877-782-7684","12-20130508@179, Exp 11/3/2013",,"750 units","Lack of Assurance of Sterility: Avella Specialty Pharmacy is recalling bevacizumab and vancomycin due to concerns of sterility assurance with the specialty pharmacy's independent testing laboratory.",9/9/2013,"09/09/2013",9/25/2013,"09/25/2013"
"Devices",66211,"Ongoing","Stryker Endoscopy","San Jose","CA","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Worldwide Distribution - USA including AL, AK, AZ, AR, CA, CO, CT, DE, FL, GA, HI, ID, IL, IN, IA, KS, KY, LA, ME, MD, MA, MI, MN, MS, MO, MT, NE, NV, NH, NJ, NM, NY, NC, ND, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VT, VA, WA, WV, WI, WY and internationally to Australia, Canada, Chile, China, Argentina, Guam, Taiwan, India, Japan, Korea, Latin America, Philippines, Mexico, New Zealand, Hong Kong, Singapore, and Switzerland.","Z-2271-2013","Class II","Stryker Vision Mounting Arm, for use with other Stryker Endoscopy medical device products for human patients. Model number 0240-095-200, manufactured by Stryker Endoscopy San Jose The intended use of the Stryker Vision Mount is to hold and position an LCD monitor. The Stryker Vision Mounting Arm can be used with any Stryker flat panel display and is It is compatible with Stryker Carts (0240099001, 0240099011 or 0240099020). It is indicated for use in a surgical operating room environment and is exposed to environmental conditions associated with the storage and shipping of the product. It is not intended to enter the sterile field. The Stryker Vision Mount does not deliver to and/or extract from the patient any energy or material. It does not process any biological materials, as it is not intended to be sterilized by the user. The Stryker Vision Mount is only used to display surgical images and video and does not sustain or support life.","Model number 0240-095-200, all serial numbers.",".","14271 units","When positioning the display located on top of the video cart, it is possible for the user to apply excessive force and push the display up and out of the mounting arm. This can result in the display falling upon the user/patient.",8/30/2013,"08/30/2013",10/2/2013,"10/02/2013"
"Biologics",66212,"Terminated","Blood Systems, Inc.","Reno","NV","US","Voluntary: Firm Initiated","Telephone","Nevada","B-0022-14","Class II","Fresh Frozen Plasma","W041912026066B",".","1 unit","Blood products, collected from a donor who was previously deferred for testing positive for the human immunodeficiency virus, were distributed.",8/22/2013,"08/22/2013",12/11/2013,"12/11/2013"
"Biologics",66212,"Terminated","Blood Systems, Inc.","Reno","NV","US","Voluntary: Firm Initiated","Telephone","Nevada","B-0023-14","Class II","Red Blood Cells Leukocytes Reduced","W041912026066B",".","1 unit","Blood products, collected from a donor who was previously deferred for testing positive for the human immunodeficiency virus, were distributed.",8/22/2013,"08/22/2013",12/11/2013,"12/11/2013"
"Biologics",66213,"Terminated","Blood Systems Inc ","Scottsdale","AZ","US","Voluntary: Firm Initiated","FAX","Arizona","B-0067-14","Class III","Fresh Frozen Plasma (Apheresis)","W041013106516V",".","1 unit","Blood products, which were incorrectly tested for West Nile Virus, were distributed.",7/12/2013,"07/12/2013",12/11/2013,"12/11/2013"
"Biologics",66213,"Terminated","Blood Systems Inc ","Scottsdale","AZ","US","Voluntary: Firm Initiated","FAX","Arizona","B-0070-14","Class III","Plasma Frozen within 24 hours (FP24)","W041013100599F",".","1 unit","Blood products, which were incorrectly tested for West Nile Virus, were distributed.",7/12/2013,"07/12/2013",12/11/2013,"12/11/2013"
"Biologics",66214,"Terminated","Blood Systems Inc ","Scottsdale","AZ","US","Voluntary: Firm Initiated","Telephone","Arizona","B-0024-14","Class III","Red Blood Cells (Apheresis) Leukocytes Reduced Irradiated","W041013106706J (2 units)",".","2 units","Blood products, which were out of controlled storage for greater than 30 minutes during irradiation, were distributed.",7/16/2013,"07/16/2013",12/11/2013,"12/11/2013"
"Biologics",66215,"Terminated","Blood Systems Inc","Lafayette","LA","US","Voluntary: Firm Initiated","Telephone","Louisiana","B-0004-14","Class II","Red Blood Cells Leukocytes Reduced","W042013029821E",".","1 unit","Blood product, collected from a donor for whom donor suitability was not adequately determined, was distributed.",7/9/2013,"07/09/2013",12/11/2013,"12/11/2013"
"Biologics",66216,"Terminated","OneBlood, Inc.","Hialeah","FL","US","Voluntary: Firm Initiated","Telephone","Florida","B-0005-14","Class II","Red Blood Cells (Apheresis) Leukocytes Reduced","2251295 (2 units)",".","2 units","Blood products, collected from a donor for whom donor suitability was not adequately determined, were distributed.",8/9/2013,"08/09/2013",12/11/2013,"12/11/2013"
"Drugs",66217,"Ongoing","Altaire Pharmaceuticals, Inc.","Aquebogue","NY","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Nationwide","D-375-2014","Class I","Carboxymethylcellulose Sodium 0.5% Ophthalmic Solution, 1 FL OZ (30 mL) bottle, sold under the following labels: (a) CVS pharmacy brand LUBRICANT EYE DROPS FOR MILD TO MODERATE DRY EYE, Distributed by CVS Pharmacy, Inc., Woonsocket, RI 02895, UPC 0 50428 053357 7 and UPC 0 50428 27364 7; (b) equate brand Lubricant Eye Drops, Distributed by Wal-Mart Stores, Inc., Bentonville, AR 72716, UPC 6 81131 03420 3; and (c) up & up brand lubricant eye drops, Dist. by Target Corporation, Minneapolis, MN 55403, UPC 8 58961 79102 0. ","Lot #: 11440, Exp 09/13, labeled for CVS; 11441, Exp 09/13, labeled for CVS; 12042, Exp 01/14, labeled for CVS and Wal-Mart ; 12103, Exp 02/15, labeled for Wal-Mart; 12203, Exp 05/15, labeled for CVS and Wal-Mart; 12207, Exp 05/15, labeled for Wal-Mart; 12293, Exp 08/15, labeled for Wal-Mart; 12352, Exp 09/15, labeled for CVS and Target; and 12356, Exp 09/15, labeled for CVS and Target.",".","363,746 bottles.","Non-Sterility: Customer complaints of mold in the product after use and handling due to the fact that the preservative used in the lots of Carboxymethylcellulose Sodium 0.5% Ophthalmic Solution may not be effective through expiry. ",9/6/2013,"09/06/2013",12/26/2013,"12/26/2013"
"Drugs",66218,"Ongoing","Kremers Urban Pharmaceuticals, Inc.","Seymour","IN","US","Voluntary: Firm Initiated",,"KY & TN","D-009-2014","Class II","Omeprazole Delayed-Release Capsules, USP, 20 mg, Rx Only, 1000 Capsules per bottle, Distributed by: Kremers Urban Pharmaceuticals Inc. Princeton, NJ 08540, USA, NDC: 62175-118-43 ","Lot Number 59627; Expiration Date 02/2014",,"3867 bottles","Failed Tablet/Capsule Specification: some capsules over time do not meet or are suspected to not meet the specification for acid resistance. ",9/16/2013,"09/16/2013",11/27/2013,"11/27/2013"
"Devices",66219,"Ongoing","Carefusion 211 Inc dba Carefusion","Yorba Linda","CA","US","Voluntary: Firm Initiated","Letter","Worldwide distribution: US (nationwide) including Puerto Rico and countries of: Albania, American Samoa, Argentina, Australia, Austria, Bahrain, Barbados, Bangladesh, Belgium, Bermuda, Belize, Bolivia, Bosnia and Herzegovina, Brazil, Canada, Chile,China, Colombia, Costa Rica, Croatia, Cyprus, Czech Rep, Dominican Republic, Ecuador, Egypt, Estonia, El Salvador, Finland, France, Germany, Georgia, Greece, Guatemala, Hong Kong, Honduras, Hungary, India, Indonesia, Ireland, Israel, Italy, Japan, Jordan, Korea, Kuwait, Latvia, Lebanon, Lithuania, Lybia Jamahiriya, Malaysia, Mexico, Moldova, Morocco, Netherlands, Nepal, Nicaragua, Norway, Oman, Pakistan, Palastine, Panama, Paraguay, Peru, Philippines, Poland, Portugal, Qatar, Romania, Russian Federation, Rwanda, Saudi Arabia, Singapore, Slovenia, Slovakia, Spain, Switzerland, Taiwan, Thailand, Tunisia, Turkey, United Arab Emirates, and United Kingdom.","Z-2273-2013","Class I","Product Name: AVEA Ventilator. All Models. The affected devices are cleared under K073069 pm 1/25/2008 and K103211 on 05/06/2011. This device is a Class II medical Device. A continuous ventilator (respirator) is a device intended to mechanically control or assist patient breathing by delivering a predetermined percentage of oxygen in the breathing gas. Adult, pediatric, and neonatal ventilators are included in this generic type of device.","All Models. Serial Numbers: BCV01807 AEV01754 AFV01269 AFV01692 AFV01694 AFV02330 AFV02338 AFV02339 AFV02349 AFV02350 AFV02515 AGV01817 AGV01818 AGV02135 AGV02189 AGV02296 AGV02306 AGV02344 AHV03372 AJV01001 AJV01242 AJV01292 AJV01297 AJV01300 AJV01301 AJV01701 AJV01702 AJV01703 AJV01716 AJV01718 AJV01732 AJV01733 AJV01746 AJV01748 AJV01749 AJV01819 AJV01820 AJV01824 AJV02086 AJV02088 AJV02089 AJV02090 AJV02091 AJV02093 AJV02097 AJV02099 AJV02208 AJV02306 AJV02311 AJV02320 AJV02321 AJV02322 AJV02323 AJV02324 AJV02325 AJV02326 AJV02327 AJV02328 AJV02329 AJV02330 AJV02331 AJV02332 AJV02333 AJV02334 AJV02335 AJV02337 AJV02338 AJV02341 AJV02342 AJV02343 AJV02344 AJV02345 AJV02346 AJV02347 AJV02349 AJV02350 AJV02351 AJV02352 AJV02353 AJV02354 AJV02355 AJV02356 AJV02357 AJV02358 AJV02359 AJV02965 AKV01257 AKV01272 AKV01303 AKV01304 AKV01305 AKV01306 AKV01307 AKV01308 AKV01309 AKV01310 AKV01311 AKV01312 AKV01313 AKV01323 AKV01324 AKV01325 AKV01326 AKV01327 AKV01328 AKV01329 AKV01333 AKV01334 AKV01336 AKV01337 AKV01338 AKV01339 AKV01345 AKV01347 AKV01348 AKV01350 AKV01351 AKV01355 AKV01358 AKV01362 AKV01920 AKV01944 BAV04617 BAV04618 BAV04619 BAV04620 BAV04621 BAV04623 BAV04624 BAV04625 BAV04626 BAV04629 BAV04799 BAV04800 BAV04801 BAV04802 BAV04803 BBV01262 BBV01263 BBV01264 BBV01265 BBV01266 BBV01267 BBV01268 BBV01269 BBV01270 BBV01271 BBV03347 BBV03353 BBV03354 BBV03356 BBV03357 BBV03361 BBV03366 BBV03555 BBV03627 BBV03628 BBV03629 BBV03630 BBV03631 BBV03632 BBV03633 BBV03634 BBV03635 BBV03636 BBV03637 BBV03638 BBV03639 BBV03640 BBV03641 BBV03642 BBV03643 BBV03644 BBV03645 BBV03646 BBV03647 BBV03648 BBV03649 BBV03652 BBV03653 BBV03654 BBV03655 BBV03656 BBV03657 BBV03658 BBV03659 BBV03710 BBV03711 BBV03712 BCV02567 BCV02590 BCV02598 BCV02604 BCV02607 BCV02608 ACV01035 ACV01054 ACV01058 ACV01061 ACV01092 ACV01099 ACV01500 ACV01501 ACV01503 ACV01504 ACV01505 ACV01510 ACV01511 ACV01512 ACV01515 ACV01519 ACV01525 ACV01526 ACV01529 ACV01537 ACV01538 ACV01539 ACV01540 ACV01542 ACV01545 ACV01547 ACV01552 ACV01554 ACV01556 A"," AHV01307 AHV01308 AHV01309 AHV01310 AHV01319 AHV01321 AHV01322 AHV01325 AHV01326 AHV01327 AHV01331 AHV01339 AHV01343 AHV01347 AHV01348 AHV01349 AHV01350 AHV01351 AHV01352 AHV01353 AHV01354 AHV01355 AHV01357 AHV01358 AHV01359 AHV01360 AHV01362 AHV01363 AHV01365 AHV01366 AHV01370 AHV01381 AHV01382 AHV01383 AHV01393 AHV01394 AHV01395 AHV01396 AHV01397 AHV01398 AHV01399 AHV01401 AHV01402 AHV01403 AHV01404 AHV01405 AHV01407 AHV01409 AHV01410 AHV01411 AHV01414 AHV01416 AHV01418 AHV01419 AHV01421 AHV01422 AHV01424 AHV01425 AHV01428 AHV01429 AHV01432 AHV01434 AHV01437 AHV01439 AHV01440 AHV01441 AHV01442 AHV01443 AHV01444 AHV01445 AHV01446 AHV01449 AHV01450 AHV01452 AHV01453 AHV01454 AHV01455 AHV01456 AHV01457 AHV01459 AHV01460 AHV01461 AHV01462 AHV01463 AHV01466 AHV01467 AHV01468 AHV01470 AHV01471 AHV01472 AHV01473 AHV01475 AHV01476 AHV01477 AHV01479 AHV01480 AHV01481 AHV01482 AHV01484 AHV01486 AHV01487 AHV01488 AHV01489 AHV01490 AHV01492 AHV01493 AHV01495 AHV01496 AHV01497 AHV01498 AHV01500 AHV01501 AHV01508 AHV01515 AHV01518 AHV01521 AHV01525 AHV01526 AHV01540 AHV01549 AHV01552 AHV01557 AHV01558 AHV01565 AHV01575 AHV01577 AHV01578 AHV01580 AHV01584 AHV01585 AHV01586 AHV01591 AHV01593 AHV01594 AHV01598 AHV01600 AHV01601 AHV01602 AHV01604 AHV01609 AHV01610 AHV01611 AHV01613 AHV01614 AHV01615 AHV01616 AHV01617 AHV01618 AHV01620 AHV01621 AHV01622 AHV01626 AHV01629 AHV01631 AHV01632 AHV01633 AHV01634 AHV01636 AHV01637 AHV01639 AHV01643 AHV01646 AHV01648 AHV01650 AHV01656 AHV01661 AHV01662 AHV01664 AHV01665 AHV01679 AHV01680 AHV01681 AHV01682 AHV01687 AHV01691 AHV01692 AHV01694 AHV01696 AHV01699 AHV01700 AHV01701 AHV01704 AHV01705 AHV01711 AHV01712 AHV01713 AHV01716 AHV01718 AHV01722 AHV01727 AHV01728 AHV01730 AHV01731 AHV01736 AHV01738 AHV01739 AHV01744 AHV01745 AHV01746 AHV01748 AHV01753 AHV01758 AHV01761 AHV01764 AHV01768 AHV01770 AHV01771 AHV01772 AHV01778 AHV01784 AHV01786 AHV01787 AHV01793 AHV01798 AHV01799 AHV01807 AHV01811 AHV01814 AHV01815 AHV01816 AHV01819 AHV01827 AHV01830 AHV01837 AHV01839 AHV01849 AHV01857 A","19,546 units","CareFusion has identified a potential risk associated with AVEA ventilators when used at higher altitudes. A proactive complaint review identified an error in the barometric pressure compensation. CareFusion is voluntarily initiating a field correction of the affected devices to correct the error.",9/5/2013,"09/05/2013",10/9/2013,"10/09/2013"
"Food",66220,"Ongoing","General Mills, Inc","Minneapolis","MN","US","Voluntary: Firm Initiated","Press Release","AL, AZ, AR, CA, CO,CT, FL, GA, ID, IL, IN, KS,KY, LA, ME, MD,MA, MI, MN, MS,MO, MT, NE, NV, NH, NJ, NM, NY, NC, ND, OH, OK, OR, PA, SC, SD, TN, TX, UT, VA, WA, WI, WY.","F-1896-2013","Class II","Pills bury Cinnamon Rolls with Icing, CINNA BON, USPC 1800000501, 1800052230, 12.4 oz and 2-pack USPC 1800045675,2- 12.4 oz (351 G) CANS, NET WT 24.8 OZ (1 LB 8.8 OZ 703 G.","Better if Used Date on Package: 30OCT2013, 31OCT2013, 18OCT2013, 26OCT2013 and 31OCT2013.",,"49,352 cases (12 units/case)","General Mills is recalling a limited quantity of refrigerated Pills bury Cinnamon Rolls with Icing. The dough may contain fragments from a broken piece of plastic on the production line. ",9/6/2013,"09/06/2013",9/25/2013,"09/25/2013"
"Food",66221,"Ongoing","Vinco Inc.","Evans City","PA","US","Voluntary: Firm Initiated","Letter","Nationwide.","F-0008-2014","Class II","Vinco's Fem-Vite Women's Anti-Oxidant Formula, Dietary Supplement, 60 Tablets, distributed by Vinco, Inc., Evans City, PA ","Fem-Vite UPC 739930205086, lot numbers 11080560, 11080562, 12100217, 12100218 with expiration dates 10/13 to 2/15.",".",,"The soy ingredient used to manufacture certain lots of Vinco's Fem-Vite was potentially contaminated with Salmonella. ",6/28/2013,"06/28/2013",10/30/2013,"10/30/2013"
"Food",66221,"Ongoing","Vinco Inc.","Evans City","PA","US","Voluntary: Firm Initiated","Letter","Nationwide.","F-0006-2014","Class II","Vinco's OsteoSheath Enhanced Bone Support, Calcium Supplement, 90 Tablets, distributed by Vinco, Inc., Evans City, PA; ","Osteoshealth UPC 739930205048, lot numbers 11080772 through 11080775, 12040763 through 12040767, 120101069 through 12101073 with expiration dates 10/13 to 2/15. ",".",,"The soy ingredient used to manufacture certain lots of Vinco's Osteosheath was potentially contaminated with Salmonella. ",6/28/2013,"06/28/2013",10/30/2013,"10/30/2013"
"Food",66221,"Ongoing","Vinco Inc.","Evans City","PA","US","Voluntary: Firm Initiated","Letter","Nationwide.","F-0007-2014","Class II"," Vinco's OsteoSheath 4 Enhanced Bone Support, Calcium Supplement, 120 Tablets, distributed by Vinco, Inc., Evans City, PA ","Osteosheath 4 UPC 739930275195, lot numbers 11060198 through 1106199, 11100897through 1110898, 1204780 through 1204781, 120101089 through 120101090, 13020640 through 13020641 with expiration dates 10/13 to 2/15. ",".",,"The soy ingredient used to manufacture certain lots of Vinco's Osteosheath 4 was potentially contaminated with Salmonella. ",6/28/2013,"06/28/2013",10/30/2013,"10/30/2013"
"Devices",66222,"Ongoing","Baxter Healthcare Corp.","Deerfield","IL","US","Voluntary: Firm Initiated","Letter","Nationwide distribution.","Z-0109-2014","Class II","Vented Spike Adapter Product Code 2C0471, Sterile, nopyrogenic. Manufactured by an affiliate of Baxter Healthcare Corporation, Clintec Nutrition Division, Deerfield IL 60015 USA. An IV transfer device, used to transfer fluids in pharmacy compounding system.","R13D09024, R13D09107, R13D12101, R13D17068, R13D18066, R13D20070",,"49,344 units","Potential tears in the pouch of six lots of Vented Spike Adapter Product Code 2C0471",8/30/2013,"08/30/2013",11/6/2013,"11/06/2013"
"Devices",66222,"Ongoing","Baxter Healthcare Corp.","Deerfield","IL","US","Voluntary: Firm Initiated","Letter","Nationwide distribution.","Z-0109-2014","Class II","Vented Spike Adapter Product Code 2C0471, Sterile, nopyrogenic. Manufactured by an affiliate of Baxter Healthcare Corporation, Clintec Nutrition Division, Deerfield IL 60015 USA. An IV transfer device, used to transfer fluids in pharmacy compounding system.","R13D09024, R13D09107, R13D12101, R13D17068, R13D18066, R13D20070",,"49,344 units","Potential tears in the pouch of six lots of Vented Spike Adapter Product Code 2C0471",8/30/2013,"08/30/2013",11/6/2013,"11/06/2013"
"Devices",66223,"Completed","Access Scientific Inc","San Diego","CA","US","Voluntary: Firm Initiated","Visit","Distributed in MI and TX.","Z-2254-2013","Class II","POWERWAND Safety Introducer with Extended Dwell Catheter; Catalog no. 92006. Used to gain access to the vascular system to sample blood and administer fluids intravenously."," Lot no. I666473",,"160 units","Access Scientific is recalling the POWERWAND Saftey Introducer with Extended Dwell Catheter because it is mislabeled.",8/16/2013,"08/16/2013",9/25/2013,"09/25/2013"
"Food",66224,"Ongoing","KDK Management, Inc., dba Bubbles Baking Co.","Van Nuys","CA","US","Voluntary: Firm Initiated","Press Release","CA & Arizona","F-1909-2013","Class I","First Street Blueberry Muffins (S 45395), 14 oz., 9 trays/case, UPC 0 4151210833 4","Lot Codes: 12355, 12361, 12365, 12365, 13013, 13007, 13008, 13022, 13029, 13030, 13031, 13001, 13032, 13038, 13039, 13042, 13049, 13050, 13051, 13058, 13059, 13063, 13064, 13070, 13073, 13079, 13084, 13085, 13086, 13091, 13093, 13094, 13098, 13099, 13102, 13105, 13107, 13114, 13115, 13116, 13122, 13123, 13124, 13128, 13129, 13130, 13134, 13140, 13142, 13143, 13151, 13152, 13152, 13154, 13156, 13157, 13162, 13163, 13165,13169, 13170, 13171, 13173, 13175, 13176, 13177, 13178, 13183, 13184, 13187, 13192, 13198, 132013,13200, 13199, 13210,13217, 13219, 13220,13221, 13233, 13235, 13237, 13239.",".","9,229 cases","Bubbles Baking Co. is recalling Blueberry muffins and Loaf cakes because they may contain undeclared milk and soy.",9/10/2013,"09/10/2013",10/2/2013,"10/02/2013"
"Food",66224,"Ongoing","KDK Management, Inc., dba Bubbles Baking Co.","Van Nuys","CA","US","Voluntary: Firm Initiated","Press Release","CA & Arizona","F-1910-2013","Class I","First Street Blueberry Muffins Loaf (S 45383), 16 oz., 12 trays/case, UPC 0 41512 10854 9.","Lot Codes: 12355, 12361, 12365, 12365, 13013, 13007, 13008, 13022, 13029, 13030, 13031, 13001, 13032, 13038, 13039, 13042, 13049, 13050, 13051, 13058, 13059, 13063, 13064, 13070, 13073, 13079, 13084, 13085, 13086, 13091, 13093, 13094, 13098, 13099, 13102, 13105, 13107, 13114, 13115, 13116, 13122, 13123, 13124, 13128, 13129, 13130, 13134, 13140, 13142, 13143, 13151, 13152, 13152, 13154, 13156, 13157, 13162, 13163, 13165,13169, 13170, 13171, 13173, 13175, 13176, 13177, 13178, 13183, 13184, 13187, 13192, 13198, 132013,13200, 13199, 13210,13217, 13219, 13220,13221, 13233, 13235, 13237, 13239.",".","9,229 cases total","Bubbles Baking Co. is recalling Blueberry muffins and Loaf cakes because they may contain undeclared milk and soy.",9/10/2013,"09/10/2013",10/2/2013,"10/02/2013"
"Drugs",66226,"Ongoing","Osmotica Pharmaceutical Corp","Marietta","GA","US","Voluntary: Firm Initiated","Letter","Nationwide","D-1067-2013","Class III","Venlafaxine (Venlafaxine Hydrochloride) extended release Tablets, 225 mg, packaged in a) 30- count bottle (NDC 0131-3268-32) and b) 90-count bottle (NDC: 0131-3268-46), Rx only, Manufactured by: Kremers Urban Pharmaceuticals Inc. For: Osmotica Pharmaceutical Corp., Wilmington, NC 28405, USA.","Lot #: a) 58975, 58976, 58977, 65165 , Exp 01/14; b) 58973, 58974, 65131, Exp: 01/14",,"57857 bottles","Failed Dissolution Specification; 12 hour time point at 18 months shelf life",9/16/2013,"09/16/2013",10/9/2013,"10/09/2013"
"Food",66227,"Ongoing","The Dannon Company, Inc.","Tarrytown","NY","US","Voluntary: Firm Initiated","Letter","Nationwide.","F-0076-2014","Class II","DANNON OIKOS Fruit on the Bottom GREEK NONFAT YOGURT BLUEBERRY 0% FAT","Expiration codes: 24 SEP 2013 PS and 25 SEP 2013 PS",".","10,833 cases (12 cups per case)","OIKOS Nonfat Yogurt Blueberry Flavor Single Serve 5.3 oz cups were recalled because the lid correctly identifies the product but the cup is incorrectly labeled as blackberry flavor. Additionally, the product is blueberry flavored but the ingredient statement is for the blackberry flavor, which does not declare carmine, a potential allergen ingredient that is used in manufacturing the blueberry flavored product. ",8/30/2013,"08/30/2013",10/30/2013,"10/30/2013"
"Biologics",66228,"Terminated","OneBlood, Inc.","Hialeah","FL","US","Voluntary: Firm Initiated","Letter","Florida","B-0003-14","Class II","Red Blood Cells (Apheresis) Leukocytes Reduced","2317580 (2 units)",".","2 units","Blood products, collected from a donor for whom donor suitability was not adequately determined, were distributed.",8/14/2013,"08/14/2013",12/11/2013,"12/11/2013"
"Biologics",66229,"Terminated","Michigan Blood","Saginaw","MI","US","Voluntary: Firm Initiated","FAX","Michigan","B-0061-14","Class III","Platelets Pheresis Leukocytes Reduced","W120613205108, W120613205160",".","2 units","Blood products, collected using an automated collection device that was not validated after repairs, were distributed.",8/12/2013,"08/12/2013",12/11/2013,"12/11/2013"
"Biologics",66229,"Terminated","Michigan Blood","Saginaw","MI","US","Voluntary: Firm Initiated","FAX","Michigan","B-0060-14","Class III","Platelets Pheresis Leukocytes Reduced Irradiated","W120613205108, W120613205160",".","2 units","Blood products, collected using an automated collection device that was not validated after repairs, were distributed.",8/12/2013,"08/12/2013",12/11/2013,"12/11/2013"
"Biologics",66230,"Terminated","OneBlood, Inc.","Hialeah","FL","US","Voluntary: Firm Initiated","Telephone","Florida, New York","B-0062-14","Class II","Fresh Frozen Plasma","1137692",".","1 unit","Blood products, collected from a donor for whom donor suitability was not adequately determined, were distributed.",8/5/2013,"08/05/2013",12/11/2013,"12/11/2013"
"Biologics",66230,"Terminated","OneBlood, Inc.","Hialeah","FL","US","Voluntary: Firm Initiated","Telephone","Florida, New York","B-0063-14","Class II","Red Blood Cells","1137692, 1455382",".","2 units","Blood products, collected from a donor for whom donor suitability was not adequately determined, were distributed.",8/5/2013,"08/05/2013",12/11/2013,"12/11/2013"
"Devices",66231,"Ongoing","Siemens Medical Solutions USA, Inc","Malvern","PA","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution - USA (nationwide) and internationally to Canada.","Z-0374-2014","Class II"," (Siemens Rad Fluoro Uro Systems) Ysio, Luminos Agile, Luminos dRF, and Uroskop Omnia systems with software version VC10 Image intensified fluoroscopic x-ray system","Model numbers: 10094200, 10094910, 10281013, 10281163, 10502200",".","357","A potential malfunction and hazard to patients exists when using the Ysio, Luminos Agile, Luminos dRF, and Uroskop Omnia systems with software version VC10, which may result in radiation continuing longer than required and overexposed images that are not of diagnostic quality. ",9/3/2013,"09/03/2013",12/4/2013,"12/04/2013"
"Drugs",66232,"Ongoing","Novartis Consumer Health","Lincoln","NE","US","Voluntary: Firm Initiated","Letter","Nationwide","D-022-2014","Class III","Loratadine, USP 10 mg, Antihistamine, packaged in blister packs. All manufactured by Novartis Consumer Health, Inc, Lincoln, NE / There are 7 different labels under which this product is packaged but the active ingredient is the same. 1) DOLLAR GENERAL LABEL: DG Health Allergy Relief, Loratadine, USP 10 mg, Antihistamine, packaged in 60 tablet blister packs (UPC code: 300436122) and 30 tablet blister packs (UPC code: 300676122304). Distributed by Dolgencorp, LLC, Goodlettsville, TN. 2) FAMILY DOLLAR LABEL: Family Wellness Allergy Relief, Loratadine, USP 10 mg, Antihistamine, packaged in 30 tablet blister packs (UPC code: 032251004292). Distributed by Family Dollar Services, Inc, Matthews, NC. 3) FAMILY DOLLAR LABEL Family Dollar Allergy Relief, Loratadine, USP 10 mg, Antihistamine, packaged in 30 tablet blister packs (UPC code: 400910131502). Manufactured by Novartis Consumer Health, Inc, Lincoln, NE and Distributed by Family Dollar Services, Inc, Charlotte, NC. 4) TARGET LABEL: Allergy Relief Medication, loratadine, 10 mg/antihistamine, packaged in 10 tablet (UPC 300670675103), 15 tablet (UPC 300670668150), 30 tablet (UPC 300670675301), 40 tablet (UPC 300670675400), and 60 tablet (UPC 300670675004) blister packs. It is also packaged in 120 tablet (UPC 300670675127) and 180 tablet (UPC 300676255736) bottles. Dist. by Target Corporation, Minneapolis, MN. 5) PRIVATE LABEL: Loratadine 10mg, Antihistamine, packaged in 10 tablet (UPC 300670674106) and 30 tablet (UPC 300670674304) blister packs. Manufactured and Distributed by: Novartis Consumer Health, Inc., Lincoln, NE. 6) WALMART LABEL, Equate, Allergy Relief, Loratadine Tablets, 10 mg, Antihistamine, packaged in 10 tablet (UPC 681131739276) and 30 tablet (UPC 681131739283) blister packs. Distributed by: Wal-Mart Stores, Inc., Bentonville, AR. 7) CVS LABEL: CVS Pharmacy, Allergy Relief, Loratadine 10mg/Antihistamine, packaged in 5 tablet (UPC 050428068595), 10 tablet (UPC 050428046784), 20 tablet (UPC 050428065747) (UPC 050428579350), and 30 ","1) DG Health Allergy Relief 60 tablet packages: Lot 10114571, exp 4/14 and Lot 10114573, exp 5/14. 30 tablet packages lot and exp date: 10098129, 9/13; 10099649, 10/13; 10101302, 11/13; 10103516, 12/13; 10103517, 12/13; 10106238, 1/14; 10109436, 2/14; 10111296, 3/14; 10112222, 3/14 and 10114573, 5/14. 2) DG Health Allergy Relief Lot number and exp date: 10122379, 8/14. 3) Family Dollar Allergy Relief Lot number and exp date: 10098127, 9/13; 10098129, 9/13; 10099649, 10/13; 10099650, 10/13; 10101299, 11/13; 10101303, 11/13; 10103517, 12/13; 10106236, 1/14; 10106237, 1/14; 10107030, 2/14; 10109434, 2/14; 10109436, 2/14; 10109438, 2/14; 10109861, 3/14; 10109863, 2/14; 10112223, 3/14; 10116503, 5/14; 10116506, 6/14 and 10118377, 7/14. 4) Target Allergy Relief Lot number and exp date: 10 ct blister pack: 10098127, 9/13; 10103516, 12/13; 10106238, 1/14; 10109863, 2/14; 10111298, 3/14; 10111300, 3/14; 10118377, 7/14; 10122382, 10/14 and 10126772, 11/14. 15 ct blister pack: 10101299, 11/13, 10109434, exp 2/14 and 10103515, 12/13. 30 ct blister pack: 10098127, 9/13; 10099646, 9/13; 10099648, 10/13; 10101298, 11/13; 10101303, 11/13; 10106234, 12/13; 10106235, 12/13; 10106237, 1/14; 10107028, 1/14; 10109437, 2/14; 10109864, 2/14; 10112221, 3/14; 10114570, 4/14; 10114571, 4/14; 10114572, 4/14; 10116505, 5/14; 10118374, 6/14; 10122380, 9/14; 10122382, 10/14 and 10126771, 10/14. 5) PRIVATE LABEL Lot number and exp date: 10 ct blister pack: 10099646, 9/13; 10099649, 10/13; 10099650, 10/13; 10101298, 11/13; 10103516, 12/13; 10103517, 12/13; 10106238, 1/14; 10109434, 2/14; 10109863, 2/14; 10112221, 3/14; 10112223, 3/14; 10118377, 7/14 and 10122381, 9/14. 30 ct blister pack: 10098127, 9/13; 10099646, 9/13; 10099648, 10/13; 10099649, 10/13; 10099650, 10/13; 10101298, 11/13; 10103516, 12/13; 10106235, 12/13; 10107030, 2/14; 10109436, 2/14; 10109864, 2/14; 10111297, 3/14; 10112221, 3/14; 10114569, 4/14; 10114570, 4/14; 10114571, 4/14; 10116503, 5/14; 10116504, 5/14; 10116505, 5/14; 10118376, 7/14; 10118",".","11,846,608 blister packs","Failed Tablet/Capsule Specifications: The products are being recalled due to chipped and broken tablets.",9/3/2013,"09/03/2013",12/4/2013,"12/04/2013"
"Drugs",66233,"Ongoing","Tween Brands Inc","New Albany","OH","US","Voluntary: Firm Initiated","E-Mail","Nationwide","D-362-2014","Class III","I LOVE BACON Justice, VANILLA scent anti bac, Ethyl Alcohol, Net Wt. 1 fl oz, Distr by Tween Brands New Albany, OH 43054 Toronto, ON L6T 3R5 ","Style #191274",".","16,471 bottles","Labeling: Label Error on Declared Strength; the label states that the product contains 62% ethyl alcohol, but the ethyl alcohol content is 20%.",6/21/2013,"06/21/2013",12/26/2013,"12/26/2013"
"Drugs",66233,"Ongoing","Tween Brands Inc","New Albany","OH","US","Voluntary: Firm Initiated","E-Mail","Nationwide","D-360-2014","Class III","GIRLS ROCK Justice, VANILLA scent anti bac, Ethyl Alcohol, Net Wt. 1 fl oz, Distr by Tween Brands New Albany, OH 43054 Toronto, ON L6T 3R5","Style #191272",".","9,558 bottles","Labeling: Label Error on Declared Strength; the label states that the product contains 62% ethyl alcohol, but the ethyl alcohol content is 20%.",6/21/2013,"06/21/2013",12/26/2013,"12/26/2013"
"Drugs",66233,"Ongoing","Tween Brands Inc","New Albany","OH","US","Voluntary: Firm Initiated","E-Mail","Nationwide","D-358-2014","Class III","Lemon anti bac Justice, Ethyl Alcohol, Net Wt. 1 fl oz, Distr by Tween Brands New Albany, OH 43054 Toronto, ON L6T 3R5","Style #190847 &190871",".","27,590 bottles","Labeling: Label Error on Declared Strength; the label states that the product contains 62% ethyl alcohol, but the ethyl alcohol content is 20%.",6/21/2013,"06/21/2013",12/26/2013,"12/26/2013"
"Drugs",66233,"Ongoing","Tween Brands Inc","New Albany","OH","US","Voluntary: Firm Initiated","E-Mail","Nationwide","D-354-2014","Class III","LIFE IS SWEET! Justice, Vanilla Scent anti bac, Ethyl Alcohol, Net Wt. 1 fl oz, Distr by Tween Brands New Albany, OH 43054 Toronto, ON L6T 3R5","Style #190788",".","58,054 bottles","Labeling: Label Error on Declared Strength; the label states that the product contains 62% ethyl alcohol, but the ethyl alcohol content is 20%.",6/21/2013,"06/21/2013",12/26/2013,"12/26/2013"
"Drugs",66233,"Ongoing","Tween Brands Inc","New Albany","OH","US","Voluntary: Firm Initiated","E-Mail","Nationwide","D-352-2014","Class III","FOLLOW YOUR DREAMS! Justice, Chocolate anti bac, Ethyl Alcohol, Net Wt. 1 fl oz, Distr by Tween Brands New Albany, OH 43054 Toronto, ON L6T 3R5","Style #190786 & 190867",".","65,332 bottles","Labeling: Label Error on Declared Strength; the label states that the product contains 62% ethyl alcohol, but the ethyl alcohol content is 20%.",6/21/2013,"06/21/2013",12/26/2013,"12/26/2013"
"Drugs",66233,"Ongoing","Tween Brands Inc","New Albany","OH","US","Voluntary: Firm Initiated","E-Mail","Nationwide","D-350-2014","Class III","Shine from within blueberry Anti bac Justice, Ethyl Alcohol, Net Wt 1 fl oz, Distr by Tween Brands New Albany, OH 43054 Toronto, ON L6T 3R5","Style #190784 & 190866",".","25,078 bottles","Labeling: Label Error on Declared Strength; the label states that the product contains 62% ethyl alcohol, but the ethyl alcohol content is 20%.",6/21/2013,"06/21/2013",12/26/2013,"12/26/2013"
"Drugs",66233,"Ongoing","Tween Brands Inc","New Albany","OH","US","Voluntary: Firm Initiated","E-Mail","Nationwide","D-351-2014","Class III","Girls can change the World, Green Apple Anti bac Justice, Ethyl Alcohol, Net Wt 1 fl oz, Distr by Tween Brands New Albany, OH 43054 Toronto, ON L6T 3R5 Made in China","Style #190785",".","42,570 units","Labeling: Label Error on Declared Strength; the label states that the product contains 62% ethyl alcohol, but the ethyl alcohol content is 20%.",6/21/2013,"06/21/2013",12/26/2013,"12/26/2013"
"Drugs",66233,"Ongoing","Tween Brands Inc","New Albany","OH","US","Voluntary: Firm Initiated","E-Mail","Nationwide","D-361-2014","Class III","I MUSTACHE YOU TO BE MY BFF Justice, COTTON CANDY scent anti bac, Ethyl Alcohol, Net Wt. 1 fl oz, Distr by Tween Brands New Albany, OH 43054 Toronto, ON L6T 3R5 ","Style #191273",".","20,167 bottles","Labeling: Label Error on Declared Strength; the label states that the product contains 62% ethyl alcohol, but the ethyl alcohol content is 20%.",6/21/2013,"06/21/2013",12/26/2013,"12/26/2013"
"Drugs",66233,"Ongoing","Tween Brands Inc","New Albany","OH","US","Voluntary: Firm Initiated","E-Mail","Nationwide","D-364-2014","Class III","yum yum bubble gum Justice, BUBBLEGUM SCENT ANTI BAC, Ethyl Alcohol, Net Wt. 1 fl oz, Distr by Tween Brands New Albany, OH 43054 Toronto, ON L6T 3R5 ","Style #191278",".","12,326 bottles","Labeling: Label Error on Declared Strength; the label states that the product contains 62% ethyl alcohol, but the ethyl alcohol content is 20%.",6/21/2013,"06/21/2013",12/26/2013,"12/26/2013"
"Drugs",66233,"Ongoing","Tween Brands Inc","New Albany","OH","US","Voluntary: Firm Initiated","E-Mail","Nationwide","D-349-2014","Class III","Share a Smile Mixed berry Anti bac Justice, Ethyl Alcohol, Net Wt. 1 fl oz, Distr by Tween Brands New Albany, OH 43054 Toronto, ON L6T 3R5 ","Style #190783 & 190865",".","48,647 bottles","Labeling: Label Error on Declared Strength; the label states that the product contains 62% ethyl alcohol, but the ethyl alcohol content is 20%.",6/21/2013,"06/21/2013",12/26/2013,"12/26/2013"
"Drugs",66233,"Ongoing","Tween Brands Inc","New Albany","OH","US","Voluntary: Firm Initiated","E-Mail","Nationwide","D-353-2014","Class III","TODAY IS AWESOME! Justice, Cotton Candy anti bac, Ethyl Alcohol, Net Wt. 1 fl oz, Distr by Tween Brands New Albany, OH 43054 Toronto, ON L6T 3R5 ","Style #190787 & 190868",".","47,343 bottles","Labeling: Label Error on Declared Strength; the label states that the product contains 62% ethyl alcohol, but the ethyl alcohol content is 20%.",6/21/2013,"06/21/2013",12/26/2013,"12/26/2013"
"Drugs",66233,"Ongoing","Tween Brands Inc","New Albany","OH","US","Voluntary: Firm Initiated","E-Mail","Nationwide","D-355-2014","Class III","I love my BFF Justice, Watermelon anti bac, Ethyl Alcohol, Net Wt. 1 fl oz, Distr by Tween Brands New Albany, OH 43054 Toronto, ON L6T 3R5 ","Style #190844 & 190869",".","47,051 bottles","Labeling: Label Error on Declared Strength; the label states that the product contains 62% ethyl alcohol, but the ethyl alcohol content is 20%.",6/21/2013,"06/21/2013",12/26/2013,"12/26/2013"
"Drugs",66233,"Ongoing","Tween Brands Inc","New Albany","OH","US","Voluntary: Firm Initiated","E-Mail","Nationwide","D-363-2014","Class III","YOU CANT HANDLE THIS Justice, GRAPE SCENT ANTI BAC, Ethyl Alcohol Net Wt. 1 fl oz, Distr by Tween Brands New Albany, OH 43054 Toronto, ON L6T 3R5 ","Style #191276",".","15,931 bottles","Labeling: Label Error on Declared Strength; the label states that the product contains 62% ethyl alcohol, but the ethyl alcohol content is 20%.",6/21/2013,"06/21/2013",12/26/2013,"12/26/2013"
"Drugs",66233,"Ongoing","Tween Brands Inc","New Albany","OH","US","Voluntary: Firm Initiated","E-Mail","Nationwide","D-365-2014","Class III","BFF's are COOL! Justice, CHERRY SCENT ANTI BAC, Ethyl Alcohol, Net Wt. 1 fl oz, Distr by Tween Brands New Albany, OH 43054 Toronto, ON L6T 3R5","Style #191365",".","4,692 bottles","Labeling: Label Error on Declared Strength; the label states that the product contains 62% ethyl alcohol, but the ethyl alcohol content is 20%.",6/21/2013,"06/21/2013",12/26/2013,"12/26/2013"
"Drugs",66233,"Ongoing","Tween Brands Inc","New Albany","OH","US","Voluntary: Firm Initiated","E-Mail","Nationwide","D-356-2014","Class III","I love sleep overs Justice, Grape anti bac, Ethyl Alcohol, Net Wt. 1 fl oz, Distr by Tween Brands New Albany, OH 43054 Toronto, ON L6T 3R5","Style #190845 & 190870",".","21,201 bottles","Labeling: Label Error on Declared Strength; the label states that the product contains 62% ethyl alcohol, but the ethyl alcohol content is 20%.",6/21/2013,"06/21/2013",12/26/2013,"12/26/2013"
"Drugs",66233,"Ongoing","Tween Brands Inc","New Albany","OH","US","Voluntary: Firm Initiated","E-Mail","Nationwide","D-359-2014","Class III","Grapefruit anti bac Justice, Ethyl Alcohol, Net Wt. 1 fl oz, Tocopheryl Acetate,*** Distr by Tween Brands New Albany, OH 43054 Toronto, ON L6T 3R5","Style #190848 & 190872",".","18,492 bottles","Labeling: Label Error on Declared Strength; the label states that the product contains 62% ethyl alcohol, but the ethyl alcohol content is 20%.",6/21/2013,"06/21/2013",12/26/2013,"12/26/2013"
"Drugs",66233,"Ongoing","Tween Brands Inc","New Albany","OH","US","Voluntary: Firm Initiated","E-Mail","Nationwide","D-357-2014","Class III","I love to shop Justice, Peach anti bac, Ethyl Alcohol, Net Wt. 1 fl oz, Distr by Tween Brands New Albany, OH 43054 Toronto, ON L6T 3R5","Style #190846",".","23,231 bottles","Labeling: Label Error on Declared Strength; the label states that the product contains 62% ethyl alcohol, but the ethyl alcohol content is 20%.",6/21/2013,"06/21/2013",12/26/2013,"12/26/2013"
"Drugs",66233,"Ongoing","Tween Brands Inc","New Albany","OH","US","Voluntary: Firm Initiated","E-Mail","Nationwide","D-348-2014","Class III","Believe in Yourself Strawberry Anti bac Justice, Ethyl Alcohol, Net Wt 1 fl oz., Distr by Tween Brands New Albany, OH 43054 Toronto, ON L6T 3R5","Style #190782 & 190864",".","86,701 bottles","Labeling: Label Error on Declared Strength; the label states that the product contains 62% ethyl alcohol, but the ethyl alcohol content is 20%.",6/21/2013,"06/21/2013",12/26/2013,"12/26/2013"
"Devices",66234,"Ongoing","Smiths Medical ASD, Inc.","Saint Paul","MN","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution - USA including AZ, AR, CA, GA, IL, IN, KY, MD, MA, MI, NV, NJ, NY, NC, OH, OR, PA, RI, SC, TN, TX, VA, WA, WV, WY. Internationally to DENMARK, BELGIUM CANADA.","Z-2268-2013","Class II","Smith Medical, Deltec, REF 21-2386-24, 11 Fr Introducer Set with Peel-Away Sheath, Sterile EO, Rx Only PORT-A-CATH and PORT-A-CATH II implantable venous and arterial access systems are designed to permit repeated access to the vascular system for the parenteral delivery of medications, fluids, and nutritional solutions and for the sampling of venous blood. Introducer sets are indicated for the introduction of catheters into the subclavian vein.","1991524 1997100 2033224 2051222 2116286 2183921 2192487 2210967 2229821 2237453",".","190","Smiths Medical is conducting a voluntary recall of PORT-A-CATH and PORT-A-CATH II Implantable Venous and Arterial Access Systems and Introducer Sets. Smiths Medical has become aware of a small number of customer reports regarding the introducer sheath and the introducer opening being too small for the width of the catheter with the use of these Sets. Smiths Medical has received no reports of serious injury or death related to this issue.",9/10/2013,"09/10/2013",10/2/2013,"10/02/2013"
"Devices",66234,"Ongoing","Smiths Medical ASD, Inc.","Saint Paul","MN","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution - USA including AZ, AR, CA, GA, IL, IN, KY, MD, MA, MI, NV, NJ, NY, NC, OH, OR, PA, RI, SC, TN, TX, VA, WA, WV, WY. Internationally to DENMARK, BELGIUM CANADA.","Z-2269-2013","Class II","Smiths Medical, Deltec: REF 21-8011-24 Port-A-Cath Dual-Lumen. Titanium Venous Access System. REF 21-8052-24 & REF 21-8053-24 , Port-A-Cath II Dual-Lumen, Polysulfone /Titanium Venous Access System. Sterile EO, Rx Only. PORT-A-CATH and PORT-A-CATH II implantable venous and arterial access systems are designed to permit repeated access to the vascular system for the parenteral delivery of medications, fluids, and nutritional solutions and for the sampling of venous blood. Introducer sets are indicated for the introduction of catheters into the subclavian vein. ","21-8011-24: 1971567 1979805 1984078 1997124 2006124 2038001 2090898 2151160 2196530 2216256 2249695 21-8052-24: 1971572 2012472 2022904 2067947 2080704 2146472 2168988 2196532 2207404 2237458 2249696 2269178 2282158 21-8053-24: 2168989 2249697",".","372","Smiths Medical is conducting a voluntary recall of PORT-A-CATH and PORT-A-CATH II Implantable Venous and Arterial Access Systems and Introducer Sets. Smiths Medical has become aware of a small number of customer reports regarding the introducer sheath and the introducer opening being too small for the width of the catheter with the use of these Sets. Smiths Medical has received no reports of serious injury or death related to this issue.",9/10/2013,"09/10/2013",10/2/2013,"10/02/2013"
"Food",66236,"Ongoing","GE PHARMA LLC -","North Haven","CT","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Nationwide and Worldwide","F-0116-2014","Class II","Creafuse Grape, 600 Grams","4568 ",".","480 units","Product contains 1,3 dimethylamylamine (DMAA)",9/1/2013,"09/01/2013",11/13/2013,"11/13/2013"
"Food",66236,"Ongoing","GE PHARMA LLC -","North Haven","CT","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Nationwide and Worldwide","F-0117-2014","Class II","Creafuse Fruit Punch, 600 Grams","4570",".","480 ","Product contains 1,3 dimethylamylamine (DMAA)",9/1/2013,"09/01/2013",11/13/2013,"11/13/2013"
"Devices",66237,"Ongoing","Philips Medical Systems (Cleveland) Inc","Cleveland","OH","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution-USA including the states of AL, AR, CA, FL, GA, IL, IN, KY, MS, NC, NJ, NV, NY, OH, PA, and VA; and countries of: Albania, Algeria, Argentina, Australia, Austria, Belgium, Bolivia, Brazil, Cambodia, China, Ghana, Greece, India, Indonesia, Ireland, Italy, Jordan, Latvia, Lebanon, Libya, Lithuania, Malawi, Mexico, Nepal, Netherlands, Oman, Palestine, Philippines, Poland, Portugal, Romania, Russia, Saudi Arabia, Singapore, South Africa, South Korea, Spain, Switzerland, Thailand, Turkey, Uganda, Ukraine, Uzbekistan, Venezuela and Vietnam.","Z-0019-2014","Class II","MX 16-Slice CT Scanner System. Used as a whole-body computed tomography X-Ray system.","Model # 728131 510(k) K083498 Serial #: EP16E090001, EP16E090002, EP16E090003, EP16E090006, EP16E090009, EP16E090010, EP16E090011, EP16E090012, EP16E090013, EP16E090015, EP16E100001, EP16E100004, EP16E100006, EP16E100008, EP16E100010, EP16E100012, EP16E100013, EP16E100016, EP16E100017, EP16E100018, EP16E100019, EP16E100020, EP16E100021, EP16E100022, EP16E100023, EP16E100024, EP16E100025, EP16E100026, EP16E100028, EP16E100029, EP16E100031, EP16E100032, EP16E100033, EP16E100034, EP16E100035, EP16E100037, EP16E100038, EP16E100039, EP16E100041, EP16E100043, EP16E100044, EP16E100045, EP16E100046, EP16E100047, EP16E100049, EP16E100051, EP16E100052, EP16E100055, EP16E100056, EP16E100058, EP16E100059, EP16E100060, EP16E100062, EP16E100063, EP16E100067, EP16E100069, EP16E100070, EP16E100071, EP16E100072, EP16E100073, EP16E100074, EP16E100075, EP16E100076, EP16E100077, EP16E100078, EP16E100079, EP16E100081, EP16E100082, EP16E100083, EP16E100084, EP16E100085, EP16E100086, EP16E100087, EP16E100088, EP16E100090, EP16E100091, EP16E100093, EP16E100094, EP16E100095, EP16E100096, EP16E100100, EP16E100101, EP16E100103, EP16E100104, EP16E100105, EP16E100106, EP16E100107, EP16E100108, EP16E100109, EP16E100110, EP16E100112, EP16E100113, EP16E110003, EP16E110005, EP16E110006, EP16E110009, EP16E110011, EP16E110012, EP16E110013, EP16E110014, EP16E110015, EP16E110017, EP16E110018, EP16E110019, EP16E110020, EP16E110021, EP16E110023, EP16E110024, EP16E110025, EP16E110026, EP16E110029, EP16E110030, EP16E110031, EP16E110035, EP16E110037, EP16E110038, EP16E110042, EP16E110043, EP16E110044, EP16E110045, EP16E110046, EP16E110047, EP16E110048, EP16E110049, EP16E110050, EP16E110051, EP16E110054, EP16E110055, EP16E110056, EP16E110058, EP16E110060, EP16E110063, EP16E110064, EP16E110066, EP16E110067, EP16E110069, EP16E110074, EP16E110075, EP16E110077, EP16E110078, EP16E110080, EP16E110083, EP16E110084, EP16E110085, EP16E110089, EP16E110090, EP16E110091, EP16E110092, EP16E110093, EP16E110095, EP16E110096, EP16E110097, EP16E110099, EP16E110100, E",,"326","A pinch point at the end of the table top can cause injury.",7/22/2013,"07/22/2013",10/23/2013,"10/23/2013"
"Devices",66238,"Ongoing","Baxter Healthcare Corp.","Deerfield","IL","US","Voluntary: Firm Initiated",,"US Distribution including the states of OK, GA, CA, MN, TX and HI.","Z-0099-2014","Class II","Baxter CLEARLINK System Non-DEHP Three Lead Extension Set. 6.0'' (15 cm), 1.0 mL, Luer Activated Valve, male Luer Lock Adapter, Sterile, nonpyrogenic, Baxter Healthcare Corporation, Deerfield IL 60015. For use with a vascular access device for the administration of drugs and solutions. The Clearlink Luer Activated Valve is an in-line injection site, which can be connected to standard male Luer adapters for continuous or intermittent fluid administration or the withdrawal of fluids.","UR13C11089, UR13D16060",,"3,200 units","The firm is issuing a voluntary recall due to the potential for pinholes in the packaging. Pinholes are a breach in the sterile barrier and could lead to potential contamination.",9/4/2013,"09/04/2013",11/6/2013,"11/06/2013"
"Devices",66238,"Ongoing","Baxter Healthcare Corp.","Deerfield","IL","US","Voluntary: Firm Initiated",,"US Distribution including the states of OK, GA, CA, MN, TX and HI.","Z-0099-2014","Class II","Baxter CLEARLINK System Non-DEHP Three Lead Extension Set. 6.0'' (15 cm), 1.0 mL, Luer Activated Valve, male Luer Lock Adapter, Sterile, nonpyrogenic, Baxter Healthcare Corporation, Deerfield IL 60015. For use with a vascular access device for the administration of drugs and solutions. The Clearlink Luer Activated Valve is an in-line injection site, which can be connected to standard male Luer adapters for continuous or intermittent fluid administration or the withdrawal of fluids.","UR13C11089, UR13D16060",,"3,200 units","The firm is issuing a voluntary recall due to the potential for pinholes in the packaging. Pinholes are a breach in the sterile barrier and could lead to potential contamination.",9/4/2013,"09/04/2013",11/6/2013,"11/06/2013"
"Devices",66239,"Ongoing","Roche Diagnostics Operations, Inc.","Indianapolis","IN","US","Voluntary: Firm Initiated","Letter","Nationwide Distribution and Puerto Rico","Z-0168-2014","Class II","COBAS INTEGRA 800 Analyzer with software 9864.C2 Cobas. COBAS Part Numbers 28122474001, 28122474692, 04559126001, 04589459970 corresponding to the Analyzer with or without closed tube sampling accessory A fully automated system for clinical chemistry analysis intended for the in vitro quantitative/qualitative determination of analytes in body fluids. ","software version 9864.C2",".","527 units","Roche COBAS INTEGRA 800 system, Software Version 9864.C2 does not perform necessary ISE Service Actions. Whenever the ISE rack is removed, the ISE counters in the software are reset to zero and the corresponding Service Actions are not conducted automatically by the system. Additionally, certain maintenance activities that have to be performed manually by the operator are not requested on the software by the due date. This software issue ONLY affects systems performing ISE tests.",9/16/2013,"09/16/2013",11/13/2013,"11/13/2013"
"Biologics",66240,"Ongoing","Fenwal Inc","Lake Zurich","IL","US","Voluntary: Firm Initiated","Letter","Nationwide and Canada","B-0076-14","Class III","Blood Pack Unit with an Integrally Attached Container of ADSOL Red Cell Preservation Solution. NDC# 0942-6453-03","FM13E09013",".","1 unit","Mislabeled Blood-Pack Units were distributed. ",9/3/2013,"09/03/2013",12/11/2013,"12/11/2013"
"Drugs",66241,"Ongoing","Apothecary Shoppe","Tulsa","OK","US","Voluntary: Firm Initiated","Telephone","Oklahoma","D-66241-001","Class II","Estradiol 1.25 mg, Progesterone 25 mg/mL injectable, 20 mL sterile vials, The Apothecary Shoppe, 6136 E. 51st St. Tulsa, OK 74135.","Lot 05022013@20, Exp 10/29/13",,"3540 mL","Lack of Assurance of Sterility: concerns of sterility assurance with the pharmacy's independent testing laboratory.",9/6/2013,"09/06/2013",10/9/2013,"10/09/2013"
"Drugs",66241,"Ongoing","Apothecary Shoppe","Tulsa","OK","US","Voluntary: Firm Initiated","Telephone","Oklahoma","D-66241-002","Class II","SIH-Testosterone Cypionate 200 mg/mL Injectable, 10 mL sterile vial, The Apothecary Shoppe, 6136 E. 51st St. Tulsa, OK 74135. ","Lot #s: 05132013@25, Exp 11/9/13; 08072013@4, Exp 2/3/14",,"1,430 mL","Lack of Assurance of Sterility: concerns of sterility assurance with the pharmacy's independent testing laboratory.",9/6/2013,"09/06/2013",10/9/2013,"10/09/2013"
"Devices",66242,"Ongoing","GE Healthcare, LLC","Waukesha","WI","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution USA including DC, all states except HI, ND, RI and WY and Internationally to Australia, Bahrain, Belarus, Belgium, Brazil, Canada, Chile, China, Czech Republic, Denmark, Egypt, Finland, France, Germany, Greece, Hong Kong, India, Indonesia, Israel, Italy, Japan, Korea (Republic of), Kuwait, Lebanon, Martinique, Mexico, Netherlands, New Zealand, Norway, Oman, Poland, Qatar, Russia, Saudi Arabia, Serbia, Singapore, South Africa, Spain, Sweden, Switzerland, Taiwan, Turkey, United Arab Emirates, United Kingdom, Uruguay, . OUS: AUSTRALIA, AUSTRIA, BAHRAIN, BELARUS, BELGIUM, BRAZIL, CANADA, CHILE, CHINA, CROATIA, CZECH REPUBLIC, DENMARK, EGYPT, FINLAND, FRANCE, GERMANY, GREECE, HONG KONG, INDIA, INDONESIA, ISRAEL, ITALY, JAPAN, REPUBLIC OF KOREA, KUWAIT, LEBANON, MARTINIQUE, MEXICO, NETHERLANDS, NEW ZEALAND, NORWAY, OMAN, POLAND, QATAR, RUSSIA, SAUDI ARABIA, SERBIA, SINGAPORE, SOUTH AFRICA, SPAIN, SWEDEN, SWITZERLAND, TAIWAN, TURKEY, UNITED ARAB EMIRATES, UNITED KINGDOM, URUGUAY.","Z-2291-2013","Class II","GE Healthcare, Discovery MR750 3.0T, Optima MR450w 1.5T, and Discovery MR450 1.5T . scanner designed to support high resolution, high signal-to-noise ratio, and short scan times. The GE Signa MR 750 System is indicated for use as a diagnostic imaging device to produce axial, sagittal, coronal, and oblique images, spectroscopic images, parametric maps, and/or spectra, dynamic images of the structures and organs of the entire body, including but not limited to, head, neck, TMJ, spine, breast, heart, abdomen, pelvis, joints, prostate, blood vessels, and musculoskeletal regions of the body. The images produced by the GE Signa MR 750 System reflect the spatial distribution or molecular environment of nuclei exhibiting magnetic resonance. These images when interpreted by a trained physician yield information that may assist in diagnosis. The indications for use for the 3.0T GE Signa MR750 System are similar to those for the Signa HDx Magnetic Resonance System and the Siemens MAGNETOM Verio MR System. K113490: The Optima'' MR450w is a whole body magnetic resonance scanner designed to support high resolution, high signal-to-noise ratio, and short scan times. It is indicated for use as a diagnostic imaging device to produce axial, sagittal, coronal, and oblique images, spectroscopic images, parametric maps, and/or spectra, dynamic images of the structures and/or functions of the entire body, including but not limited to, head, neck, TMJ, spine, breast, heart, abdomen, pelvis, joints, prostate, blood vessels, and musculoskeletal regions of the body. Depending on the region of interest being images, contrast agents may be used. The images produced by the Optima'' MR 450w reflect the spatial distribution or molecular environment of nuclei exhibiting magnetic resonance. These images and/or spectra when interpreted by a trained physician yield information that may assist in diagnosis. K083147: The Discovery MR 450 is a whole body magnetic resonance scanner designed to support high resolution, high signal-to-noise ratio, a","Mfg Lot or Serial # 00000029854MR5 00000288907MR9 00000289309MR7 00000289310MR5 00000289961MR5 00000290050MR4 00000290137MR9 00000290202MR1 00000290457MR1 00000290502MR4 00000290659MR2 00000290773MR1 00000290957MR0 00000291185MR7 00000291325MR9 00000291363MR0 00000291397MR8 00000291464MR6 00000291489MR3 00000292367MR0 00000292471MR0 00000292528MR7 00000292634MR3 00000292843MR0 00000293065MR9 00000293874MR4 00000294098MR9 00000294398MR3 00000294472MR6 00000294556MR6 00000294576MR4 00000294718MR2 00000295111MR9 00000295134MR1 00000295215MR8 00000296070MR6 00000296097MR9 00000296171MR2 00000296226MR0 00000296228MR0 00000296300MR7 00000296369MR2 00000296429MR4 00000296462MR5 00000296469MR0 00000296626MR5 00000296829MR5 00000296840MR2 00000296841MR0 00000296860MR0 00000297134MR9 00000297147MR1 00000297355MR0 00000297387MR3 00000297493MR9 00000297833MR6 00000297880MR7 00000297891MR4 00000298050MR6 00000298114MR0 00000298247MR8 00000298248MR6 00000298249MR4 00000298310MR4 00000298386MR4 00000298387MR2 00000298494MR6 00000298512MR5 00000298535MR6 00000298552MR1 00000298573MR7 00000298574MR5 00000298655MR2 00000298656MR0 00000298675MR0 00000298722MR0 00000298727MR9 00000298834MR3 00000298836MR8 00000298861MR6 00000298869MR9 00000298870MR7 00000298889MR7 00000298901MR0 00000298932MR5 00000298943MR2 00000298959MR8 00000299141MR2 00000299160MR2 00000299161MR0 00000299171MR9 00000299172MR7 00000299173MR5 00000299199MR0 00000299200MR6 00000299230MR3 00000299264MR2 00000299294MR9 00000299320MR2 00000299339MR2 00000299411MR9 00000299491MR1 00000299503MR3 00000299522MR3 00000299559MR5 00000299560MR3 00000299627MR0 00000299634MR6 00000299645MR2 00000299647MR8 00000299683MR3 00000299823MR5 00000299851MR6 00000299952MR2 00000300038MR7 00000300039MR5 00000300122MR9 00000300296MR1 00000300473MR6 00000300493MR4 00000300494MR2 00000300564MR2 00000300565MR9 00000300571MR7 00000300572MR5 00000300588MR1 00000300590MR7 00000300883MR6 00000300906MR5 00000300929MR7 00000300967MR7 00000300985MR9 00000301126MR9 00000301292MR9 00000301401MR6 ",,"828 (443 US, 385 OUS)","GE Healthcare has recently become aware of a potential safety issue due to exposed yellow foam on the end bells of Discovery MR450, Discovery MR750, and Optima MR450w products. The yellow foam strip used between the end bell covers and patient bore of certain GE MR Products may extend past the surface of the covers. The foam itself is not hazardous. However, any fluid or body substance absorbed by the extended foam may come into contact with patients and act as a fomite potentially transferring infectious agents from one patient to another.",8/13/2013,"08/13/2013",10/9/2013,"10/09/2013"
"Devices",66243,"Ongoing","Integra Limited","Plainsboro","NJ","US","Voluntary: Firm Initiated","Letter","Nationwide Distribution","Z-0117-2014","Class II","Brand Names: Integra Camino 110-4 Intracranial Pressure (ICP) Monitoring Catheters. Product / Catalogue No.s: 110-4B, 110-4BC, 110-4G, 110-4H, 110-4HC, 110-4L, 110-4LC. The fully packaged 110-4B, 110-4H, and 110-4L catheters are also provided as a component in kits that contain other cranial access devices. These kits are Catalogue No. 110-4BC, 110- 4HC, and 110-4LC respectively. Common Name: Intracranial Pressure and Pressure-Temperature Monitoring Kits Classification Name: Device, Monitoring, Intracranial Pressure 510(k) Number: K102875 The Camino 110-4 Intracranial Pressure monitoring catheters are sterile transducer-tipped pressure monitoring catheters that are used by neurosurgeons to rapidly determine and continuously monitor intracranial pressure or pressure/temperature. The Camino 110-4B catheter is used for Intracranial Pressure Monitoring in the parenchyma or subarachnoid space. The Camino 110-4G catheter is used for Post Craniotomy Subdural Pressure Monitoring. The Camino 110-4H catheter is intended for Intracranial Pressure Monitoring and Cerebrospinal fluid drainage. The Camino 110-4L catheter is intended for use with the Licox Brain Oxygen Monitoring System to measure intracranial pressure in the parenchyma. The fully packaged 110-4B, 110-4H, and 110-4L catheters are also provided as a component in kits that contain other cranial access devices. These kits are Catalogue No. 110-4BC, 110- 4HC, and 110-4LC respectively.","Product / Catalogue No.s: 110-4B, 110-4BC, 110-4G, 110-4H, 110-4HC, 110-4L, 110-4LC. Lot Numbers: Catalog Number 110-4B: 3050RX195484, 3050RX198473, 305000205426, 3050RX197641, 3050RX201421, 305000205648, 305000205652, 3050RX199149, 3050RX201407, 3050RX199850, 305000205976, 3050RY189979, 3050RX200862, 305000206178, 3050RY193648, 3050RX200486, 3050RX181026, 3050RX185115, 3050RY195484, 305000207061, 305000207062, 3050RY198473, 305000207330, 305000207334, 3050RY197641, 3050RY200862, 305000207580, 305000207892, 3050RY200486, 3050RY181026, 3050RY185115, 3050RX207330, 3050RX207334, 3050RX207580, 305000208008, 305000208510, 3050RY207892, 305000210060, 3050RX208008, 3050RX208510, 3050RX205976, 3050RX206178, 305000210563, 305000211723, 3050RX210060, 305000212616, 305000213007, 305000213191, 30500X210563, 3050RX207061, 305000214590, 3050RX205426, 30500X215502, 3050RX207062, 305000215531, 30500X216410, 3050RY199850, 305000216132, 30500X216627, 30500X217119, 3050RY217112, 305000216718, 3050RX217751, 3050RX217840, 3050RY217837, 305000217858, 30500X218369, 30500X218391, 30500X219054, 3050RY206178, 305000220708, 305000218578, 30500X220430, 305000219261, 30500X221221, 305000221226, 305000219989, 30500X222569, 305000221953, 305000221955, 30500X223153, 30500X223709, 305000223275, 305000223280, 305000222640, 30500X224142, 305000223867, 305000223866, 30500X224692, 305000224352, 305000224353, 30500X225386, 305000225045, 305000225044, 30500X225992, 305000225632, 305000225633, 30500X226540, 30500X227059, 305000226844, 305000226846, 305000226127, 30500X227564, 305000226836, 30500X227820, 305000227127, 305000227128, 30500X228194, 305000227790, 305000227789, 30500X228787, 305000228522, 305000228521, 305000228971, 305000228972, 30500X229560, 305000229328, 305000229329, 30500X229766, 30500X230087, 305000229825, 305000229826, 30500X230565, 305000230303, 305000230302, 30500X231053, 305000230780, 305000230781, 30500X231786, 305000231461, 305000231462, 30500X232331, 305000232098, 305000232099, 30500X232960, 305000232605, 305000232604, 305000",,"4 units","Blood products, in which quality control and distribution of products did not meet specifications, were distributed.",8/1/2005,"08/01/2005",11/6/2013,"11/06/2013"
"Devices",66243,"Ongoing","Integra Limited","Plainsboro","NJ","US","Voluntary: Firm Initiated","Letter","Nationwide Distribution","Z-0117-2014","Class II","Brand Names: Integra Camino 110-4 Intracranial Pressure (ICP) Monitoring Catheters. Product / Catalogue No.s: 110-4B, 110-4BC, 110-4G, 110-4H, 110-4HC, 110-4L, 110-4LC. The fully packaged 110-4B, 110-4H, and 110-4L catheters are also provided as a component in kits that contain other cranial access devices. These kits are Catalogue No. 110-4BC, 110- 4HC, and 110-4LC respectively. Common Name: Intracranial Pressure and Pressure-Temperature Monitoring Kits Classification Name: Device, Monitoring, Intracranial Pressure 510(k) Number: K102875 The Camino 110-4 Intracranial Pressure monitoring catheters are sterile transducer-tipped pressure monitoring catheters that are used by neurosurgeons to rapidly determine and continuously monitor intracranial pressure or pressure/temperature. The Camino 110-4B catheter is used for Intracranial Pressure Monitoring in the parenchyma or subarachnoid space. The Camino 110-4G catheter is used for Post Craniotomy Subdural Pressure Monitoring. The Camino 110-4H catheter is intended for Intracranial Pressure Monitoring and Cerebrospinal fluid drainage. The Camino 110-4L catheter is intended for use with the Licox Brain Oxygen Monitoring System to measure intracranial pressure in the parenchyma. The fully packaged 110-4B, 110-4H, and 110-4L catheters are also provided as a component in kits that contain other cranial access devices. These kits are Catalogue No. 110-4BC, 110- 4HC, and 110-4LC respectively.","Product / Catalogue No.s: 110-4B, 110-4BC, 110-4G, 110-4H, 110-4HC, 110-4L, 110-4LC. Lot Numbers: Catalog Number 110-4B: 3050RX195484, 3050RX198473, 305000205426, 3050RX197641, 3050RX201421, 305000205648, 305000205652, 3050RX199149, 3050RX201407, 3050RX199850, 305000205976, 3050RY189979, 3050RX200862, 305000206178, 3050RY193648, 3050RX200486, 3050RX181026, 3050RX185115, 3050RY195484, 305000207061, 305000207062, 3050RY198473, 305000207330, 305000207334, 3050RY197641, 3050RY200862, 305000207580, 305000207892, 3050RY200486, 3050RY181026, 3050RY185115, 3050RX207330, 3050RX207334, 3050RX207580, 305000208008, 305000208510, 3050RY207892, 305000210060, 3050RX208008, 3050RX208510, 3050RX205976, 3050RX206178, 305000210563, 305000211723, 3050RX210060, 305000212616, 305000213007, 305000213191, 30500X210563, 3050RX207061, 305000214590, 3050RX205426, 30500X215502, 3050RX207062, 305000215531, 30500X216410, 3050RY199850, 305000216132, 30500X216627, 30500X217119, 3050RY217112, 305000216718, 3050RX217751, 3050RX217840, 3050RY217837, 305000217858, 30500X218369, 30500X218391, 30500X219054, 3050RY206178, 305000220708, 305000218578, 30500X220430, 305000219261, 30500X221221, 305000221226, 305000219989, 30500X222569, 305000221953, 305000221955, 30500X223153, 30500X223709, 305000223275, 305000223280, 305000222640, 30500X224142, 305000223867, 305000223866, 30500X224692, 305000224352, 305000224353, 30500X225386, 305000225045, 305000225044, 30500X225992, 305000225632, 305000225633, 30500X226540, 30500X227059, 305000226844, 305000226846, 305000226127, 30500X227564, 305000226836, 30500X227820, 305000227127, 305000227128, 30500X228194, 305000227790, 305000227789, 30500X228787, 305000228522, 305000228521, 305000228971, 305000228972, 30500X229560, 305000229328, 305000229329, 30500X229766, 30500X230087, 305000229825, 305000229826, 30500X230565, 305000230303, 305000230302, 30500X231053, 305000230780, 305000230781, 30500X231786, 305000231461, 305000231462, 30500X232331, 305000232098, 305000232099, 30500X232960, 305000232605, 305000232604, 305000",,"79,887 ","Integra LifeSciences has identified through an internal evaluation that in order to comply with US FDA requirements, certain Camino Intracranial Pressure Monitoring Kits require additional labelling to indicate they are UNSAFE in an MR environment. Only the following Camino Intracranial Pressure Monitoring Kits are affected: 110-4B, 110-4BC, 110-4G, 110-4H, 110-4HC, 110-4L, 110-4LC.",9/10/2013,"09/10/2013",11/6/2013,"11/06/2013"
"Biologics",66244,"Ongoing","Haemonetics Software Solutions","El Dorado Hills","CA","US","Voluntary: Firm Initiated","Letter","Product was distributed to 34 consignees throughout the US and Puerto Rico, as well as to Saudi Arabia.","B-0008-14","Class II","ElDorado Donor Doc Software, comprehensive donor health qualification computer system, run in a native Internet Explorer browser that is displayed in kiosk mode. Versions 2.5.0, 2.5.0 (SR1), 2.6.0, 2.6 (SR1), 2.7.0","Versions 2.5.0, 2.5.0 (SR1), 2.6.0, 2.6 (SR1), 2.7.0",".","29 of 2.5.0, 30 of 2.5.0 (SR1), 35 of 2.6.0, 34 of 2.6 (SR1), 36 of 2.7.0","Blood Bank Software, with a defect or glitch, was distributed.",8/22/2013,"08/22/2013",12/11/2013,"12/11/2013"
"Biologics",66245,"Terminated","LifeServe Blood Center","Des Moines","IA","US","Voluntary: Firm Initiated","Telephone","Iowa","B-0030-14","Class II","Red Blood Cells Leukocytes Reduced Irradiated","W037913165846; ",".","1","Blood product, collected from a donor who reported travel to a malarial endemic area, was distributed.",8/19/2013,"08/19/2013",12/11/2013,"12/11/2013"
"Biologics",66246,"Terminated","Medic Inc","Knoxville","TN","US","Voluntary: Firm Initiated","Telephone","Tennessee","B-0031-14","Class II","Red Blood Cells Leukocytes Reduced","W071213029113; ",,"1","Blood product, manufactured from a unit of Whole Blood designated as a low volume collection, was distributed.",8/1/2013,"08/01/2013",12/18/2013,"12/18/2013"
"Devices",66247,"Ongoing","Steris Corporation","Mentor","OH","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution-USA (nationwide) including the states of AK, CO, FL, GA, HI, ID, IL, KS, LA, MD, MN, MO, MT, NE, NM, OH, PA, SC, UT, & WY and the countries of Australia, Canada & Spain.","Z-2263-2013","Class II","Reliance Endoscope Processing System (REPS), STERIS Corporation, 5960 Heisley Road, Mentor, OH 44060-1834 USA www.steris.com. The intended use of the REPS is washing and high level disinfection of up to two manually pre-cleaned, immersible, reusable, heat-resistant, semi-critical devices.","Model #'s: MB30001, MB30002, MB30003, MB000077, MB000078, MB000079, MB000080 and MB000081. Serial number range 3625606001 - 3608912002 ",".","266 units","The air pipe that delivers unfiltered ambient air from the procedure room into the water bottle on the listed FUJINON G5 & G8 type flexible GI endoscopes does not connect to the main air/water channel within the light guide (LG) connection head and, as a result, the air pipe does not receive forced flow during the Reliance EPS processing cycle.",8/29/2013,"08/29/2013",10/2/2013,"10/02/2013"
"Devices",66248,"Ongoing","DePuy Orthopaedics, Inc.","Warsaw","IN","US","Voluntary: Firm Initiated","Letter","Distributed in Puerto Rico and US Virgin Islands.","Z-0064-2014","Class II","SmartSet Endurance GMV, Gentamicin, REF 3105-040, Medium Viscosity Antibiotic Bone Cement, Sterile. SmartSet GMV Endurance Gentamicin, bone cements are self-curing, radiopaque, polymethyl methacrylate based cements, containing antibiotic, used for securing a metal or polymeric prosthesis to living bone in arthroplasty procedures where infection by gentamicin-sensitive organisms is a potential risk. ",".Lot #s: 1866567 2492886 2844909 3106436 3299572 3434618 F049Z40 1890991 2521804 2866892 3115022 3310546 3466958 1927220 2585596 2888115 3134757 3339992 3475370 1933603 2589374 2889319 3166736 3347549 3483245 1985488 2589379 2981608 3175434 3362229 3498627 2047388 2610503 2991395 3205074 3378764 3528522 2064474 2610505 3011228 3223183 3380098 3572240 2332458 2641279 3042105 3236354 3403313 3572270 2354798 2803352 3062608 3249497 3412748 3590469 2374539 2839097 3078622 3249526 3416122 F024ZA40",".","16,040 units","The SmartSet GMV Endurance Gentamicin Bone Cement, product ref: number 3105-040 is intended for use in indications that have not been cleared by the US FDA. The intended use stated in the IFU for the SmartSet GMV Endurance Gentamicin Bone Cement is for the fixation of prostheses to living bone in arthroplasty procedures of joints in which infection by gentamicin-sensitive organisms is a potential risk. SmartSet GMV Endurance Gentamicin Bone Cement has only been cleared by the U.S. FDA for use in the second stage of a two-stage revision for total joint arthroplasty after the initial infection has been cleared. ",9/16/2013,"09/16/2013",10/30/2013,"10/30/2013"
"Devices",66249,"Ongoing","Baxter Healthcare Corp.","Deerfield","IL","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution - USA (nationwide) and the country of Canada.","Z-0143-2014","Class II","Dual Luer Lock Cap The device is intended for use as a cap for male or female Luer ports on medical devices such as manifolds, stopcocks or sets.","10043, 10044",".","628,992 units","The firm is recalling lots 10043 and 10044 due to loose particulate matter found in the packaging. Particulate matter entering the fluid path from the Luer lock caps may result in embolic events.",9/10/2013,"09/10/2013",11/13/2013,"11/13/2013"
"Devices",66250,"Ongoing","GE Healthcare, LLC","Waukesha","WI","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution-USA (nationwide) including the states of US: AK, AZ, CA, CO, DE, FL, GA, IL, KY, LA, MD, MI, MN, MS, MT, NV, NY, NC, OH, OR, PA, SC, TX, WY, and WI and the countries of AUSTRALIA, AUSTRIA, BANGLADESH, BELGIUM, BOLIVIA, BRAZIL, CANADA, CHILE, CHINA, COST ARICA, CROATIA, CZECH REPUBLIC, EGYPT, FINLAND, FRANCE, GERMANY, GREECE, INDIA, INDONESIA, IRAQ, ITALY, JAPAN, KAZAHHSTAN, REPUBLIC OF KOREA, KUWAIT, LEBANON, LITHUANIA, MAURITITUS, MEXICO, MOROCCO, NETHERLANDS, NEW ZEALAND, NIGERIA, PAKISTAN, PERU, PHILIPPINES, POLAND, RUSSIAN FEDERATION, SAUDI ARABIA, SOUTH AFRICA, SPAIN, SWEDEN, SWITZERLAND, TAIWAN, THAILAND, TURKEY, UNITED ARAB EMIRATES, UNITED KINGDOM, VIETNAM, and VENEZUELA.","Z-0010-2014","Class I","GE Healthcare, Avance, Avance CS2, Aisys, Aespire View, and Engstrom. Intended for volume or pressure control ventilation.","Mfg Lot or Serial # APHS00701 APHS00802 APHS00729 APHS00730 APHS00700 APHS00692 APHS00932 APHS00886 APHS00861 APHS00865 APHS00866 APHS00867 APHS00868 APHS00887 APHS00888 APHS00860 APHS00881 70138420 - 1 APHS00844 APHS00711 APHS00712 5324664 - 1 APHS00703 APHS00704 5328496 - 1 APHS00690 APHS00719 APHS00720 APHS00722 APHS00723 APHS00828 APHS00834 APHS00835 APHS00836 APHS00843 APHS00809 APHS00854 APHS00855 APHS00856 APHS00857 APHS00858 APHS00691 APHS00702 APHS00705 APHS00721 APHS00807 APHS00808 APHS00811 APHS00685 APHS00695 APHS00696 APHS00697 APHS00698 APHS00699 APHS00805 APHS00806 APHS00812 APHS00810 APHS00864 APHS00643 APHS00644 APHS00645 APHS00646 APHS00647 APHS00648 APHS00649 APHS00650 APHS00651 APHS00652 APHS00653 APHS00654 APHS00655 APHS00656 APHS00657 APHS00666 APHS00667 APHS00731 APHS00732 APHS00733 APHS00734 APHS00735 APHS00736 APHS00737 APHS00738 APHS00739 APHS00740 APHS00741 APHS00742 APHS00743 APHS00744 APHS00745 APHS00748 APHS00749 APHS00750 APHS00751 APHS00752 APHS00753 APHS00754 APHS00755 APHS00756 APHS00757 APHS00758 APHS00759 APHS00760 APHS00761 APHS00762 APHS00763 APHS00764 APHS00765 APHS00766 APHS00767 APHS00768 APHS00769 APHS00770 APHS00771 APHS00772 APHS00773 APHS00774 APHS00775 APHS00776 APHS00777 APHS00778 APHS00779 APHS00780 APHS00781 APHS00782 APHS00783 APHS00784 APHS00785 APHS00786 APHS00787 APHS00788 APHS00789 APHS00790 APHS00933 APHS00686 APHS00687 APHS00688 APHS00689 APHS00706 APHS00707 APHS00710 APHS00726 APHS00826 APHS00827 APHS00838 APHS00846 APHS00847 APHS00869 APHS00871 APHS00874 APHS00875 APHS00876 APHS00882 APHS00883 APHS00884 APHS00885 APHS00872 APHS00873 APHS00693 APHS00725 APHS00801 APHS00879 APHS00880 APHS00727 APHS00728 APHS00682 APHS00877 APHS00878 APHS00849 APHS00850 APHS00852 APHS00853 APHS00839 APHS00840 APHS00841 APHS00842 APHS00677 APHS00859 APHS00253 APHS00694 APHS00804 APHS00845 APHS00862 APHS00863 ANAS01058 ANAS01059 ANAS00814 ANAS00265 ANAS01006 ANAS01007 ANAS01009 ANAS01010 ANAS01011 ANAS01012 ANAS01013 ANAS01014 ANAS01015 ANAS01026 ANAS01027 ANAS01028 ANAS0102",,"911 (252 US, 659 OUS)","GE Healthcare has recently become aware of a potential safety issue involving unresponsive buttons on the display of the Engstrm ventilator and the Aespire View, Aisys, and Avance anesthesia machines. As a result of a manufacturing issue, the buttons on the left, right, and bottom keypads may not always detect button presses. This may result in the inability to access certain menu functions which could possibly lead to delay in treatment.",8/28/2013,"08/28/2013",10/23/2013,"10/23/2013"
"Drugs",66251,"Ongoing","Watson Laboratories Inc","Corona","CA","US","Voluntary: Firm Initiated","Letter","Nationwide","D-66251-001","Class II","Oxycodone and Acetaminophen Tablets, USP 10 mg/650 mg, CII, 100 Count Bottles, Rx Only, Manufactured by: Watson Laboratories, Inc. Corona, CA 92880 USA, NDC 0591-0825-01 ","Lot #: 705791A, Exp 04/2015 ",,"10,615 bottles","Presence of Foreign Tablets/Capsules: 20 tablets of Oxycodone/APAP 7.5/500 mg were found in a sealed 100 count bottle of Oxycodone and Acetaminophen Tablets, USP 10/650 mg lot# 705791A.",9/13/2013,"09/13/2013",10/9/2013,"10/09/2013"
"Food",66252,"Ongoing","Talenti Gelato","Marietta","GA","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","AZ, CO, CT, DE, GA, IA, IN, MA, MD, MN, MO, NC, NH, NY, PA, TX and WI.","F-0003-2014","Class II","Talenti German Chocolate Cake Gelato, One Pint (473 mL), Crafted By: Talenti, Marietta, GA 30062.","Lot #: BEST BY DATE of 11/04/2014 M1, 11/24/2014 M1, and 11/24/2014 M2 on the bottom of the container; UPC #: 1 8685200063 1.",,"3,018 Cases/24,144 units","Product contains undeclared Allergen; Almonds.",9/10/2013,"09/10/2013",10/23/2013,"10/23/2013"
"Devices",66253,"Ongoing","Beckman Coulter Inc.","Brea","CA","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution-USA (nationwide) and the countries of Canada, Vietnam, Zambia, and Zimbabwe.","Z-0153-2014","Class II","ISE REF Valve, Part No. MU7638 for the AU480, AU680, and AU5800 Chemistry Analyzer. Automated chemistry analyzers that measures analytes in samples. "," AU480, Item Code: N3151200 N3151300 N3151400 N3151500 N3151600 N3151700 N3151800 N3151900 N3659600 N3659700 N3659900 N3660000 N3660200 N3660400 N3660600 N3660800 N3912500 AU480 OPA, Item Code: B11803 N3152300 N3152400 N3152500 N3152600 N3912600 AU680, Item Code: B12184 B12185 B12187 B12188 N3147100 N3147200 N3147300 N3147400 N3147500 N3148100 N3149800 N3153300 N3153700 N3153800 N3154000 N3658100 N3662100 N3662200 N3662400 N3662900 N3663000 N3910100 N3910400 N3910500 N3910800 N3910900 N3911200 N3911300 N3911900 AU680 OPA: B11474 N3148300 N3148600 N3148700 N3150500 N3912700 AU5800 OPA, Item Code: A94927 A94928 A94929 A94930 N9028030 ",".","4584 units total (1173 units in US)","The recall was initiated because Beckman Coulter has confirmed that some AU Clinical Chemistry Analyzer ISE units can experience premature ISE REF (Reference) valve failure. Premature valve failure can be detected by the presence of air bubbles in the ISE REF solution tubing on the ISE unit. If air bubbles are present, accuracy of the ISE test results may be affected.",9/9/2013,"09/09/2013",11/13/2013,"11/13/2013"
"Devices",66253,"Ongoing","Beckman Coulter Inc.","Brea","CA","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution-USA (nationwide) and the countries of Canada, Vietnam, Zambia, and Zimbabwe.","Z-0152-2014","Class II","ISE REF Valve, Part No. MU3226 for the AU400, AU640, AU2700, and AU5400 Chemistry Analyzer. Automated chemistry analyzers that measures analytes in samples. ","AU400, Item Code: 5427200 5427400 5427600 N1254000 N1254200 N1254400 N1254600 N1255000 n1255200 N1257400 N2571700 N2571800 N3658500 N3658700 N3658800 N3659000 N3659400 N3912300 N9020723 N9020724 AU400 OPA, Item Code: 5427300 5427900 N1257700 AU640, Item Code: 5900100 5900400 5900600 N1255700 N1255900 N1256100 N1256300 N1256700 N2572800 N3660900 N3661200 N3661300 N3661500 N3661700 N3661900 AU640 OPA, Item Code: 590220 5902400 A92928 A92929 AU2700, Item Code: 5996300 5996500 5998100 N1465100 N1465300 N1465500 N1465600 N1465900 N1466100 N1815200 N1815600 N1815700 N1816200 N1816300 N3155800 N3155900 N3156000 N3156100 N3156200 N3156300 N3156400 N3156500 N3156600 N3156800 N3157000 N3663100 N3663300 N3663500 N3663600 N3663800 N3663900 N3664100 N3664300 N3664500 N3664700 N3664900 N3878600 AU2700 OPA, Item Code: 5996100 N3156700 N9025844 AU5400 OPA, Item Code: 6196400 6196500 6196700 N1257900 N1258000 N3666000 N3877100 N3877200 N3877300 N3877600 N3877700 ",".","4584 units total (1173 units in US)","The recall was initiated because Beckman Coulter has confirmed that some AU Clinical Chemistry Analyzer ISE units can experience premature ISE REF (Reference) valve failure. Premature valve failure can be detected by the presence of air bubbles in the ISE REF solution tubing on the ISE unit. If air bubbles are present, accuracy of the ISE test results may be affected.",9/9/2013,"09/09/2013",11/13/2013,"11/13/2013"
"Devices",66254,"Ongoing","GE Healthcare, LLC","Waukesha","WI","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution-USA (nationwide) including DC and Puerto Rico, and except ND, SD and VT, and the countries of ALGERIA, ARGENTINA, AUSTRALIA, AUSTRIA, BELARUS, BELGIUM, BOLIVIA, BRAZIL, CANADA, CHILE, CHINA, COLOMBIA, COSTA ARICA, CROATIA, CZECH REPUBLIC, DOMINICAN REPUBLIC, ECUADOR, EGYPT, FINLAND, FRANCE, GEORGIA, GERMANY,GREECE, GUADELOUPE, GUATEMALA, HONDURAS, HONG KONG, HUNGARY, INDIA, INDONESIA, IRAN,IRELAND, ITALY, JAMAICA, JAPAN,JORDAN, KAZKHSTAN, REPUBLIC OF KOREA, KUWAIT, LEBANON, LIBYA ARAB JAMHIRIYA, LITHUANIA, MALAYSIA MALTA, MARTINIQUE, MEXICO, MOROCCO, NETHERLANDS, NEW ZEALAND, NICARAGUA, NIGERIA, NORWAY, PAKISTAN, PANAMA, PARAGUAY, PERU, PHILIPPINES, POLAND, PORTUGAL ROMANIA, RUSSIA, SAUDI ARABIA, SERBIA, SLOVAKIA, SPAIN, SWEDEN, SYRIA, TAIWAN, THAILAND, TRINIDAD AND TOBAGO, TUNISIA, TURKEY, UKRAINE, UNITED KINGDOM, and VENEZUELA.","Z-0021-2014","Class II","GE Healthcare, Advantx, Innova 2000, Innova 2100IQ, Innova 3100, Innova 3100IQ, Innova 4100, Innova 4100IQ. Intended for general purpose diagnostic fluoroscopy and radiography studies.","Mfg Lot or Serial # System ID 00000026767YY4 201982LCA 00000068001YY7 901384LCA 00000033988YY7 914737LCA 00000034024YY0 954LCA1 00000031679YY4 708216LLCA 00000952037WK0 630856LCN 00000320794BU1 082406010002 00000346260BU3 DR-27820-CO 00000991021WK7 LB1160VA01 00000058879BU8 930047946 00000484712WK5 1453 00000529468WK1 915685LCA 00000528385WK8 082406040003 00000526149WK0 66324TC 00000497670WK0 M4017051 00000512202WK3 1616LCA 00000528587WK9 62134LCV+ 00000533252WK3 00001VAS01 00000548229WK4 506857LCA 00000088970BU9 0910063030 00000233847BU3 082406030001 00000238390BU9 083016598280384 00000245186BU2 RU1488RX20 00000249068BU8 34090VAS01 00000023887YY3 205599LCV 00000055095YY4 207283LC1 00000030139YY0 210428VCATH2 00000023954YY1 212604LC2 00000048123YY4 212604LCA2 00000048175YY4 214376VADV1 00000034312YY9 215576LC2 00000063851YY0 215662LCLP1 00000034351YY7 215955LCEP 00000034379448 216343LCA 00000026282YY4 216363LC 00000023914YY5 216384LCA 00000034355YY8 304256RCL1 00000055081YY4 304487LCA 00000048177YY0 305223LCV 00000023959YY0 305325LCA 00000063853YY6 307577HCL1 00000034352YY5 317818MDI111 00000055057YY4 317818MDI170 00000026283YY2 318462BCL 00000048183YY8 352333ANGIO 00000034327YY7 404991LCA 00000048150YY7 405271UC1 00000063859YY3 405359ELCV 00000023910YY3 407646CL1 00000034390YY5 409532GLCV 00000026316YY0 412578DLX 00000034341YY8 415540ADVLCLP 00000055053YY3 423493PSL 00000048145YY7 440585LCA 00000055092YY1 440835LCA 00000034383YY0 502587SP2 00000022054YY1 502933CL2 00000026276YY6 504380ADV1 00000048128YY3 540596LCV 00000034375YY6 561650LCA 00000030105YY1 601865ADY 00000030168YY9 615544LCA 00000034306YY1 615977SP 00000023934YY3 619340VA6 00000023871YY7 619347LC 00000030130YY9 619457SCL 00000026303YY8 619457SCL2 00000034347YY5 619739LC 00000055077YY2 661282CCLV 00000063864YY3 661326CATH1 00000030134YY1 704456LCV 00000034300YY4 707546ANGIO 00000030126YY7 717782LC1 00000034372YY3 717969LCC 00000030128YY3 718270LC 00000055052YY5 727521LCV 00000034376YY4 806358LCA 00000026272YY5 813462CATH 00000023936YY8 813586ADV1 "," 00000152514MO6 865541CCL4X 00000000153MC7 212639LCA 00000128738MO2 0910163002 00000000497MC8 0910162004A 00000146365MO2 BY4015VA01 00000146354MO6 BY4026VA01 00000120208MO4 010120RX39 00000128663MO2 030232RX07 00000128679MO8 BR62349 00000000168MC5 416284INNOVA 00000120210MO0 418656CNOVA1 00000128698MO8 418656CNOVA2 00000128650MO9 519663INNOVA 00000146367MO8 082406140017 00000128720MO0 082416010002 00000128820MO8 082416010003 00000000449MC9 082416020001 00000000085MC1 082416020002 00000128674MO9 082416030001 00000120195MO3 082416040004 00000146344MO7 082416070001 00000128728MO3 082416100001 00000146351MO2 082416100004 00000128798MO6 082416120001 00000120209MO2 082416130005 00000128822MO4 082416130006 00000000448MC1 082416130008 00000120206MO8 082416140001 00000128782MO0 082416210001 00000128752MO3 082416220002 00000003026MC2 082416220005 00000000503MC3 082416220007 00000128797MO8 082416250001 00000000107MC3 082416270001 00000120215MO9 EG1112VA01 00000146358MO7 A4213138 00000146346MO2 M2052042 00000000426MC7 M23864601 00000000123MC0 R4211476 00000128727MO5 HBKR01XR04 00000120238MO1 HC1627XR20 00000128774MO7 PC8109XR02 00000128696MO2 08301621006236 00000128691MO3 0835160013A 00000120202MO7 IE1031VA03 00000120196MO1 A5221706 00000128746MO5 A5381110 00000146359MO5 A5714604 00000128753MO1 B5120716 00000000097MC6 B5346303 00000120237MO3 YX1350 00000120236MO5 YX1443 00000128724MO2 YX1475 00000128772MO1 YX1476 00000128712MO7 YX1478 00000128669MO9 JO1034VA02 00000146361MO1 MQ1000VA01 00000000127MC1 0920169001 00000000460MC6 NO1015VA03 00000128781MO2 600043VA02 00000120600MO6 PL1107VA03 00000128658MO2 PL1494VA01 00000152531MO0 RU1070VA01 00000128654MO1 RU1112VA01 00000128756MO4 RU2096VA01 00000128758MO0 RU2096VA01 00000128706MO9 SA1231VA01 00000152529MO4 DE203229 00000128815MO8 FE416040 00000000447MC3 UP389019 00000120194MO6 0853060171 00000146371MD0 0853060179 00000146371MO0 0853060179 00000146364MO5 TN1012VA01 00000146362MO9 TN1166VA01 00000146363MO7 TN1193VA01 00000146372MO8 TN1194VA01 00000146353MO8 00132VAS01 000001","2184 (1063 US. 1121 OUS)","GE Healthcare has become aware of a potential safety issue involving missing screws in the overhead Video Monitor Suspension of the Advantx, Innova 2000, Innova 2100IQ, Innova 3100, Innova 3100IQ, Innova 4100, Innova 4100IQ Cardiovascular X-ray imaging systems.",8/16/2013,"08/16/2013",10/23/2013,"10/23/2013"
"Food",66255,"Ongoing","Restaurant Depot","College Point","NY","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","NY, NJ, CT, RI, MA, PA, MD, VA","F-1945-2013","Class II","JAMES FARM brand CUT GREEN BEANS (EJOTES CORTADOS), FRESH FROZEN, NET WT. 32 OZ. (2 LBS.) 907 g, UPC 7 60695 01004 2, PRODUCT OF POLAND -- Distributed by RD/JET, LLC 15-24 132nd Street, College Point, NY 11356 --- Product is harvested, sorted, graded, washed, cut/processed and blanched before snap freezing and packing. The cut green beans are instantly quick frozen (IQF) and packaged in a pre-printed sealed plastic bag, 2 lbs. of product per bag, 12 - 2 lbs. bags per master carton.","Lots: L6X 0424130911RY, Best before 04/24/2015; L1X 0404130814RY, Best before 04/04/2015; L1X 0404130815RY, Best before 04/04/2015; L1Y 0311132059RY, Best before 03/11/2015 ",".","Potentially 35,896 lbs.","The product was found to be contaminated with Listeria monocytogenes based on private laboratory testing.",9/4/2013,"09/04/2013",10/2/2013,"10/02/2013"
"Biologics",66256,"Terminated","Coffee Memorial Blood Center","Amarillo","TX","US","Voluntary: Firm Initiated","Letter","Tennessee; New Jersey","B-0033-14","Class III","Blood and Blood Products for Reprocessing","W067309005883; ",".","1","Blood products, collected from a donor whose suitability to donate was not adequately determined, were distributed.",7/29/2013,"07/29/2013",12/11/2013,"12/11/2013"
"Biologics",66256,"Terminated","Coffee Memorial Blood Center","Amarillo","TX","US","Voluntary: Firm Initiated","Letter","Tennessee; New Jersey","B-0032-14","Class II","Red Blood Cells Leukocytes Reduced","W067309005883; ",".","1","Blood products, collected from a donor whose suitability to donate was not adequately determined, were distributed.",7/29/2013,"07/29/2013",12/11/2013,"12/11/2013"
"Biologics",66257,"Terminated","OneBlood, Inc.","Orlando","FL","US","Voluntary: Firm Initiated","Letter","Florida","B-0034-14","Class II","Red Blood Cells Leukocytes Reduced Irradiated","W038112396029; ",".","1","Blood products, collected from a donor who received a tattoo within 12 months of donating, were distributed.",8/6/2013,"08/06/2013",12/11/2013,"12/11/2013"
"Biologics",66257,"Terminated","OneBlood, Inc.","Orlando","FL","US","Voluntary: Firm Initiated","Letter","Florida","B-0035-14","Class II","Blood and Blood Products for Reprocessing","W038112396029; ",".","1","Blood products, collected from a donor who received a tattoo within 12 months of donating, were distributed.",8/6/2013,"08/06/2013",12/11/2013,"12/11/2013"
"Biologics",66258,"Terminated","The Blood Alliance, Inc.","Jacksonville","FL","US","Voluntary: Firm Initiated","E-Mail","Florida","B-0036-14","Class II","Red Blood Cells Leukocytes Reduced","W118810554933; ",".","1","Blood product, incorrectly determined to be negative for the Jka antigen, was distributed.",8/16/2013,"08/16/2013",12/11/2013,"12/11/2013"
"Biologics",66259,"Terminated","Blood Systems, Inc.","Reno","NV","US","Voluntary: Firm Initiated","Telephone","Nevada; California","B-0038-14","Class II","Platelets Pheresis Leukocytes Reduced Irradiated","W041913020112;",".","1","Blood products, with insufficient platelet yield to have been split into triple apheresis units, were distributed.",6/15/2013,"06/15/2013",12/11/2013,"12/11/2013"
"Biologics",66259,"Terminated","Blood Systems, Inc.","Reno","NV","US","Voluntary: Firm Initiated","Telephone","Nevada; California","B-0037-14","Class II","Platelets Pheresis Leukocytes Reduced","W041913020112; ",".","1","Blood products, with insufficient platelet yield to have been split into triple apheresis units, were distributed.",6/15/2013,"06/15/2013",12/11/2013,"12/11/2013"
"Drugs",66260,"Ongoing","Hospira Inc.","Lake Forest","IL","US","Voluntary: Firm Initiated","Letter","Nationwide","D-380-2014","Class I","0.25% Bupivacaine HCl Injection, USP, 2.5 mg/mL, 30 mL, Single-dose, Hospira Inc., Lake Forest, IL 60045, NDC 0409-1159-02","Lot # 18-136-DK; Exp. 6/14",".","118,100 vials","Presence of particulate matter: visible free floating and partially embedded particulate matter in the glass vials.",7/12/2013,"07/12/2013",12/26/2013,"12/26/2013"
"Drugs",66260,"Ongoing","Hospira Inc.","Lake Forest","IL","US","Voluntary: Firm Initiated","Letter","Nationwide","D-381-2014","Class I","0.75% Bupivacaine HCl Injection, USP, 7.5 mg/mL, 30 mL, Single-dose, Hospira Inc., Lake Forest, IL 60045, NDC 0409-1165-02","Lot # 23-338-DK, Exp. 11/14",".","119,600 vials","Presence of particulate matter: visible free floating and partially embedded particulate matter in the glass vials.",7/12/2013,"07/12/2013",12/26/2013,"12/26/2013"
"Food",66262,"Ongoing","JTM Provisions Co Inc","Harrison","OH","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Product was shipped to one manufacturer in MN.","F-1902-2013","Class I","Bean & Cheese Burrito Filling, 10 lb bags Labeled in part ''13210 B 1 77220 13:38 KEEP FROZEN BEAN & CHEESE BURRITO FILLING***INGREDIENTS: COOKED PINTO BEANS, WATER, CHEDDAR CHEESE***SOYBEAN OIL***STARCH-MODIFIED, ONIONS, CHEESE SAUCE BASE***CONTAINS LESS THAN 2% OF CHILI PEPPER, SALT, CHICKEN BASE***SODIUM PHOSPHATES, SPICE, CARAMEL COLOR DEHYDRATED, GARLIC, ANNATTTO EXTRACT.'' CONTAINS: Soy, Milk, Wheat JTM Food Group 200 Sales Dr. Harrison, OH 45030 Phone 800.626.2308.","Lot #13210 B 1 77220 13:38 ",,"821 cases/3/10 lb bags","Undeclared eggs in the product. The firm was notified by their customer that the product contains pasta. The pasta contains eggs which is not declared on the label.",9/11/2013,"09/11/2013",9/25/2013,"09/25/2013"
"Devices",66263,"Ongoing","Hospira Inc.","Lake Forest","IL","US","Voluntary: Firm Initiated","Letter","US Distribution in states of: : KY, MN, ND, NJ, NY, PA, and SD.","Z-0372-2014","Class II","*** 1) SYMBIQ One-Channel Infuser; *** 2) SYMBIQ Two-Channel Infuser; *** E09 batteries can be identified by the ''E09'' that is printed beneath the bar code and at the end of the serial number along the bottom of the label found on each battery; *** E10 batteries can be identified by the ''E10'' that is printed beneath the bar code and at the end of the serial number along the bottom of the label found on each battery. Symbiq is a general-purpose infuser designed to deliver fluids, solutions, medications, agents, nutritionals, electrolytes, blood and blood products for parenteral, enteral, intra-arterial, subcutaneous, or irrigation routes of administration.","*** 1) SYMBIQ One-Channel Infuser, List Number: 16026-04-01/02/03/04/25/26/43/44/45/46/51/52/53/54/55/56/57/58/65/66/69/70/77/78/79/80/81/82/83/84/87/88/89/90/93/94; *** 2) SYMBIQ Two- Channel Infuser, List Number: 16027-04-01/02/03/04/25/26/43/44/45/46/51/52/53/54/55/56/57/58/65/66/69/70/77/78/79/80/81/82/83/84/87/88/89/90/ 93/94; *** X) Battery Pack E10 Part Number: HSP3566-E10; *** X) Battery Pack E09 Part Number: HSP3566-E09",,"59 batteries","Hospira shipped the incorrect replaceable battery pack (Part No: HSP3566-E10) instead of the correct E09 battery pack (Part No. HSP3566-E09) for the Symbiq Single and Dual Channel Infusers.",8/28/2013,"08/28/2013",11/27/2013,"11/27/2013"
"Food",66265,"Ongoing","Schwebel Baking Company","Youngstown","OH","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","The product was shipped to the following states: IN, MI, NY, OH, PA & WV.","F-0086-2014","Class I","Schwebel's Golden Rich Bun with Honey, 18 oz plastic bag, 12 count, UPC 0 71319 00083 8 Product labeled in part, ''INGREDIENTS: ENRICHED WHEAT FLOUR***CONTAINS: WHEAT, SOY SCHWEBEL BAKING CO. YOUNGSTOWN, OH 44501''","Lot #CAFC8W, Best By Sept 21, Lot #CAFC7B, Best By Sept 20",,"12,642/18 oz/12 count plastic bags","Undeclared eggs.",9/12/2013,"09/12/2013",11/6/2013,"11/06/2013"
"Devices",66266,"Ongoing","Globus Medical, Inc.","Audubon","PA","US","Voluntary: Firm Initiated","Letter","USA Nationwide Distribution.","Z-0123-2014","Class II","Globus Medical MicroFuse Putty, 2.5cc and 10cc. Product Usage: MicroFuse Bone Void Filler is indicated only for bony voids or gaps that are not intrinsic to the stability of the bony structure. MicroFuse Bone Void Filleris a bone graft extender to be used with autogenous bone marrow aspirate or autograft ","Part number 838.202S (2.5cc), with lot # GBN299BB and expiration date October 2013, and lot #GBN355AB, with expiration date December 2013: and part # 838.210S (10cc) with lot # GBN319AB, with expiration date November 2013, and GBN320BB with expiration date November 2013. ",,"193","The sterility of the product cannot be assured. ",8/28/2013,"08/28/2013",11/6/2013,"11/06/2013"
"Devices",66267,"Ongoing","Siemens Healthcare Diagnostics, Inc.","Newark","DE","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution - USA (nationwide) and Mexico.","Z-0181-2014","Class II","Emit 2000 Phenobarbital Assay and Syva Emit 2000 Phenobarbital Assay","Lots: E5-E7, F1-F5, 1290, 1300, 1313, 1330, 1338, 1367, 1371, and 1380.",".","4963","Imprecision with certain lots",8/30/2013,"08/30/2013",11/13/2013,"11/13/2013"
"Devices",66268,"Ongoing","Harvest Technologies Corporation","Plymouth","MA","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution - USA Nationwide: TX, NJ, MI, AZ, GA, LA, ME, MD, AR, MO, VA, MN, GA, MA, NY, PA, CO, CA and in the countries of Australia, Brazil, China, Singapore, Vietnam, Dominican Republic.","Z-0022-2014","Class II","Harvest Graft Delivery System; Model Number: GDP-10 Product Usage: The Harvest Graft Delivery System is intended for the aspiration of bone marrow, autologous blood, plasma, or other body fluids. The system is indicated for die delivery of allograft, autograft, or synthetic bone graft materials to an orthopedic surgical site. In addition, it is designed to facilitate pre-mixing of bone graft materials with the aspirate(s), I.V. fluids, blood, plasma, platelet rich plasma, bone marrow or other specific blood component(s) as deemed necessary by the clinical use requirements.","GDP-10-0046, GDP-10-0047, GDP-10-0048, GDP-10-0050, GDP-10-0051, GDP-10-0052, GDP-10-0053, GDP-10-0054, GDP-10-0055, GDP-10i-0010",,"730 cases (3 kits per case)","Potential for leur connector to leak or have cracks. ",9/11/2013,"09/11/2013",10/23/2013,"10/23/2013"
"Biologics",66269,"Terminated","American Natl Red Cross Mid Atlantic Region","Norfolk","VA","US","Voluntary: Firm Initiated","FAX","Virginia","B-0050-14","Class II","Red Blood Cells Leukocytes Reduced","29KS23897; ",".","1","Blood product, incorrectly determined to be negative for the Fyb antigen, was distributed. ",7/15/2013,"07/15/2013",12/11/2013,"12/11/2013"
"Biologics",66270,"Terminated","Plasma Biological Services Inc","Saint Joseph","MO","US","Voluntary: Firm Initiated","E-Mail","California","B-0072-14","Class II","Source Plasma","PQ147127; ",".","1","Blood product, collected from a donor who received a body piercing within 12 months of donating, was distributed.",7/2/2013,"07/02/2013",12/11/2013,"12/11/2013"
"Food",66271,"Ongoing","Maplehurst Bakeries, Inc.","Brownsburg","IN","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","MI and OH.","F-1912-2013","Class II","Meijer 8 Inch Carrot Uniced Split Cake Layers (product is packed in bulk cartons of 24 units/paper bags lined with flexible blue plastic liner).","SKU: 00569, Lot Codes: 3221G00569, 3221H00569, 3221I00569 Shelf life (Exp. Date): Best if Used Before: 2/5/2014 ",".","1561 cases with 24 cakes/case (37464 individual cakes)","Product was found to contain foreign material, flexible plastic.",9/10/2013,"09/10/2013",10/2/2013,"10/02/2013"
"Drugs",66272,"Ongoing","Mcneil Consumer Healthcare, Div Of Mcneil-ppc, Inc.","Fort Washington","PA","US","Voluntary: Firm Initiated","Letter","Nationwide.","D-66272-001","Class II","Concentrated Motrin (ibuprofen) Infants' Drops Oral Suspension, Original Berry Flavor 1/2 fl oz bottles, 50 mg per 1.25ml, Distributed by McNeil Consumer Healthcare, Fort Washington, PA.","Lot #: DCB3T01, DDB4R01, and DDB4S01, Exp 03/31/15",,"197,532 bottles","Presence of Foreign Substance: process-related particulates which may be associated with the raw materials were observed",9/6/2013,"09/06/2013",10/23/2013,"10/23/2013"
"Food",66275,"Ongoing","GoPicnic, Inc.","Chicago","IL","US","Voluntary: Firm Initiated","Telephone","US: Nationwide","F-0175-2014","Class I","Gopicnic; Hummus & crackers; GoPicnic meal kit packaged in paperboard container. ready-to-eat meal; with professor zim zam's extraordinary sweets dark chocolate with sea salt. NET WT 4.1 OZ (116g); distributed by gopicnic brands, inc.; chicago, il 60613; www.gopicnic.com","GoPicnic Hummus & Crackers Meal; Lot Code and Best By Date: 10303, 9/24/2013; 10373, 9/26/2013; 10383, 9/26/2013; 10503, 10/29/13(7986); 10503, 11/12/13(8148); 10503, 11/13/13(5616); 10513, 11/13/13(13584); 10513, 12/3/13(9684); 10523, 12/3/2013; 10623, 12/3/2013; 10663, 12/4/2013; 10793, 125/13(3744); 10793, 12/8/13(24948); 10803, 12/5/2013; 10923, 12/6/13(13104); 10923, 12/19/13(7488); M13106, 12/19/13(3102); M13106, 12/29/13(15882); 11063, 12/19/13(6732); 11063, 12/20/13(7716); M23107, 12/29/13(750); M23107, 12/30/13(1854); M23107, 12/31/13(1572); M23143, 1/16/2014; 11143, 12/20/13(9516); 11143, 12/26/13(3012); 11143, 1/19/14(6282); 11143, 1/19/2014; M13115, 1/16/2014; M23136, 2/3/14(10992); M23136, 2/4/14(720); M23137, 2/4/14(2478); M23137, 2/14/14(11778); M13144, 2/14/2014; 11483, 2/6/2014; M13151, 3/6/14(3024); M13151, 3/15/14(1872); M23151, 3/15/2014; M23152, 3/15/2014; M23164, 3/15/2014; M13171, 3/15/2014; M13176, 3/15/2014; M23176, 3/15/2014; M13183, 2/17/2014; M23183, 3/9/2014; M13184, 3/15/14(96); M13184, 3/18/14(7488); M13184, 3/9/14(16476); M23184, 3/18/14(4212); M23184, 4/29/14(2844); M23184, 5/13/14(1074) ",".","484,124 meal kits","The chocolates included in the meal kits may contain undeclared milk allergens.",8/30/2013,"08/30/2013",11/20/2013,"11/20/2013"
"Food",66275,"Ongoing","GoPicnic, Inc.","Chicago","IL","US","Voluntary: Firm Initiated","Telephone","US: Nationwide","F-0174-2014","Class I","GoPicnic Black Bean Dip & Plantain Chips; ready-to-eat meal kit with professor zim zam's extraordinary sweets dark chocolate with orange packaged in paperboard container; NET WT 4.2 OZ (116.2g); distributed by gopicnic brands, inc.; chicago, il 60613; www.gopicnic.com; ","GoPicnic Black Bean Dip & Plantain Chip Meal; Lot Code and Best By Date: 10773, 10/15/13(1872); 10773, 10/16/13(1782); 10773, 10/8/13(11664); 10773, 8/16/13(5274); 11063, 1/28/14(774); 11063, 10/8/13(12708); 11063, 2/11/14(5832); M13107, 3/5/2014; M23107, 3/5/2014; M13137, 3/5/14(2736); M13137, 3/6/14(5616); M23137, 3/5/14(1692); M23137, 3/6/14(2004); M13165, 3/14/2014; M13175, 3/14/14(4986); M13175, 3/5/14(444); M13175, 5/6/14(3942); M13182, 4/8/14(1872); M13182, 5/19/14(876); M23182, 4/8/2014; M13197, 4/4/14(1668); M13197, 5/7/14(3486); M13197, 5/7/14(2250); M13197, 5/19/14(1206); M13201, 3/5/2014; M23204, 3/5/14(2682); M23204, 5/19/14(7632); M23204, 5/28/14(276); M23204, 5/29/14(3468); ",".","131,220 meal kits ","The chocolates included in the meal kits may contain undeclared milk allergens.",8/30/2013,"08/30/2013",11/20/2013,"11/20/2013"
"Devices",66276,"Ongoing","Kerr/Pentron, DBA Kerr Corporation and Pentron Clinical","Orange","CA","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution, including Nationwide in the US and the countries of Canada, Great Britain, Australia, France, Germany, Italy, Denmark, Hong Kong, China, Brazil and Saudi Arabia.","Z-2259-2013","Class II","NX3 Try-In Gel. The product is used as a tooth shade resin material. ","Part Number 33660. Syringe Lot Number 4580333. Autobag Lot Number 4584609.",,"197 units","Kerr Corporation is voluntarily recalling one lot of NX3 Try-In Gel, because some of the NX3 Try-In Gel syringes in the affected lot contain a different product material. The material in the affected syringe does not match the shade of the cement as it is labeled.",9/13/2013,"09/13/2013",9/25/2013,"09/25/2013"
"Devices",66277,"Ongoing","GE Healthcare, LLC","Waukesha","WI","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution - USA (nationwide) including DC., and the countries of AUSTRALIA, CANADA, CHILE, GERMANY, CHANA, GUATEMALA, ICELAND, ISRAEL, ITALY, JAMAICA, JAPAN, RUSIAN FEDERATION, UNITED ARAB EMIRATES and UNITED KINGDOM.","Z-0012-2014","Class II","GE Healthcare, Precision 500D, Legacy, RFX, and SFX X. This table is intended for use in a diagnostic X-ray system to support patients during general purpose radiological procedures in the horizontal, vertical and trendelenburg positions. - The Expedio 500D is designed to perform radiographic and fluoroscopic x-ray examinations. - The Precision 500D R&F X-ray System is intended to be used as a universal diagnostic imaging system for radiographic and fluoroscopic examinations, including general R&F and pediatric examinations. The Precision 500D R&F X-ray Systems are intended for use by a qualified/trained doctor or technician on both adult and pediatric subjects for taking diagnostic radiographic and fluoroscopic exposures of the whole body, skull, spinal column, chest, abdomen, extremities, and other body parts. Applications can be performed with the patient sitting, standing, or lying in the prone or supine position.","Serial # System ID 00000976624WK7 202884RF2410 00000977748WK3 202884RF2411 00000955594WK7 205877LRF2 00000965983WK0 207373RF1 00000969026WK4 215748LEG1 00000960066WK9 219416ADV 00000975683WK4 228809SR2 00000966338WK6 256235ORF1 00000967770WK9 301896RF 00000961102WK1 302654RF 00000972383WK4 303440BCHRM4 00000964398WK2 303730R3 00000958345WK1 304256RX1A 00000978812WK6 361552LEGD1 00000970377WK8 404321LEG2 00000973016WK9 408259RF1 00000963305WK8 408977RF5 00000963524WK4 414266RM03 00000963118WK5 417533BR2 00000969537WK0 507372LEG 00000959491WK2 518382SRM2 00000976668WK4 540862ARF6 00000966773WK4 561468RM4 00000972380WK0 606285LEGACY 00000966622WK3 619421RF1 00000957841WK0 708216GIRF1 00000983335WK1 713527PRF1 00000964482WK4 775738RM2 00000971676WK2 804289HDF4 00000978181WK6 804747DHP1 00000994573WK4 815740RF1 00000961772WK1 817472LEG1 00000963293WK6 850747ER1 00000975653WK7 856778RF2 00000965747WK9 864295GRRM4 00000973832WK9 904508LEGACY 00000962333WK1 904819RF1 00000970009WK7 907276RM3 00000953103WK9 912633MR3 00000978182WK4 915685ADV3 00000978314WK3 916784LEG 00000977043WK9 936321LEG1 00000963738WK0 941798RM2 00000982588WK6 956388RF1 00000966348WK5 972566RM11 00000962460WK2 RADNETRF130 00000963491WK6 RADNETRF137 00000978497WK6 651232RF4 00000983536WK4 703689RM03 00000011284GP7 210297BMCRF11 00000011281GP3 210297SEBRF3 00000985785WK5 281348P5001 00000014340GP4 308398RF 00000014337GP0 412641RF1 00000984897WK9 435637RM4 00000013713GP3 561863RF1 00000013860GP2 661633XR2 00000014347GP9 713636LBJ7 00000988380WK2 717272RF2 00000011676GP4 720854RF1 00000012513GP8 727823RM3 00000013045GP0 770793P500D 00000012418GP0 781744RF3 00000012521GP1 816348BRF1 00000009196GP7 817255NHPD1 00000013285GP2 828298RF4 00000011737GP4 850325RF4 00000013257GP1 850494WF4 00000014350GP3 856325P500 00000989504WK6 913676SRM4 00000013271GP2 956350VRF3 00000990179WK4 PC7479XR03 00000012826GP4 00105FLU01 00001009797WK0 303825P500 00000009180M31 202745PRE2 00000022650M36 207498P500 00000001835M38 208227ROOM6 00000005813M31 208455RF1 00000002639M33",,"810 (783 US, 27 OUS)","GE Healthcare has recently become aware of a potential safety issue involving the spotfilm device power assist handle. There is a potential for the internal bolts on the power assist handle to be loose or to loosen and/or fall out. This issue, if present, can result in a loss of calibration and offset of the power assist handle and/or, under extreme condition, sticking of the handle in the ON position. These conditions could cause the system to strike the patient. No injuries have been reported to date related to this issue.",8/30/2013,"08/30/2013",10/23/2013,"10/23/2013"
"Food",66279,"Completed","Garre Farms","Portland","OR","US","Voluntary: Firm Initiated","Letter","Distributed in California, Oregon, Washington","F-0080-2014","Class I","Green Leaf Lettuce is sold in bulk cases under ''Garre Farms'' or ''Rossi Farms'' brand. There are 24 heads of green leaf lettuce packed in each cardboard box. The Garre Farms brand is labeled in parts: ''***OREGON'S OWN!***Fresh Produce***GARRE FARMS, LLC***PORTLAND, OR 97230***PRODUCE OF U.S.A***''. The Rossi Farms brand is labeled as ''***ROSSI FARMS***3701 N.E. 122nd AVE PORTLAND, OR 97230*** PRODUCE OF U.S.A.***''.","NONE. No best by dates, no expiration dates, no lot codes.",".","498 cases/24 heads of lettuce per case","Garre Farms is recalling green leaf lettuce due to a potential contamination with Listeria monocytogenes.",9/13/2013,"09/13/2013",10/30/2013,"10/30/2013"
"Biologics",66282,"Terminated","Talecris Plasma Resources Inc","Research Triangle Park","NC","US","Voluntary: Firm Initiated","FAX","North Carolina","B-0007-14","Class II","Source Plasma","3620167925; 3620167202; 3620166781; ",".","3","Blood products, collected from a donor who received a tattoo within 12 months of donating, were distributed.",7/23/2013,"07/23/2013",12/11/2013,"12/11/2013"
"Biologics",66283,"Terminated","Community Blood Center of Carolinas","Charlotte","NC","US","Voluntary: Firm Initiated","Telephone","North Carolina","B-0051-14","Class II","Red Blood Cells Leukocytes Reduced","W227013023507; ",".","1","Blood product, collected from a donor who reported travel to an area possibly endemic for malaria, was distributed.",8/11/2013,"08/11/2013",12/11/2013,"12/11/2013"
"Biologics",66286,"Terminated","LifeSouth Community Blood Centers, Inc.","Dunwoody","GA","US","Voluntary: Firm Initiated","FAX","Georgia","B-0049-14","Class II","Platelets Pheresis Leukocytes Reduced","W115113149487B; W115113149487B; ",".","2","Blood products, tested for pH using a malfunctioning pH meter, were distributed. ",6/25/2013,"06/25/2013",12/11/2013,"12/11/2013"
"Drugs",66288,"Ongoing","Boehringer Ingelheim Roxane Inc","Columbus","OH","US","Voluntary: Firm Initiated","Letter","Nationwide and Puerto Rico","D-343-2014","Class III","Oxcarbazepine Tablets, 150 mg, packaged in a) 10 x 10 count Unit-Dose Tablets in blisters packaged in a carton (NDC 0054-0097-20) and b) 100-count bottle (NDC 0054-0097-25), Rx only, Roxane Laboratories, Inc., Columbus, Ohio 43216","Lot #: a) 259666A, Exp. MAR 2014; b) 259666B, Exp. MAR 2014",,"8,550 cartons and bottles","SubPotent Drug: The firm discovered out of specification results for assay and the extended investigation revealed the potential for lower weight tablets.",3/18/2013,"03/18/2013",12/18/2013,"12/18/2013"
"Drugs",66289,"Ongoing","Boehringer Ingelheim Roxane Inc","Columbus","OH","US","Voluntary: Firm Initiated","Letter","Nationwide","D-002-2014","Class II","Oxcarbazepine Oral Suspension, 300 mg/5 mL, 250 mL bottle, Rx only, Boehringer Ingelheim, Roxane Laboratories, Inc. Columbus, Ohio 43216, NDC 0054-0199-59","Lot # 161304B, Exp. OCT 2013",,"10,267 bottles","Resuspension Problems: Recalled lot did not meet resuspendability requirements.",4/3/2013,"04/03/2013",11/27/2013,"11/27/2013"
"Devices",66290,"Ongoing","bioMerieux, Inc.","Durham","NC","US","Voluntary: Firm Initiated","Letter","Nationwide Distribution.","Z-0087-2014","Class II","chromID Salmonella Agar, Reference No. 43621. A selective isolation and differentiation medium for the detection of Salmonella in human specimens. ","Lot 1002234210 and 1002300040",,"90","Complaints for Salmonella strains growing on this medium producing an uncharacteristic white colored colony instead of the expected pale pink to mauve colored colonies. This could potentially lead to Salmonella colonies not being detected.",9/6/2013,"09/06/2013",11/6/2013,"11/06/2013"
"Food",66291,"Ongoing","Dutch Valley Food Development Inc.","Myerstown","PA","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Nationwide","F-0004-2014","Class II","Honey Roasted Peanuts, net wt. 11 oz.., packed in a clear plastic bag. Ingredients: peanuts, sugar, peanut and/or canola and/or cottonseed oil, honey, salt, modified potato starch, xanthan gum. Allergen info: peanut and soy ingredients. Also states that facility also processes products containing, milk and wheat ingredients. Distributed by: Dutch Valley Food Distributors Inc., Myerstown, PA 17067.","All products with UPC code 8 77245 00143 3 and Best By date up to 1/21/14. ",,,"Honey Roasted Peanuts were recalled due to undeclared milk (lactose) and wheat (wheat starch) allergens in the ingredient statement. ",9/12/2013,"09/12/2013",10/23/2013,"10/23/2013"
"Food",66291,"Ongoing","Dutch Valley Food Development Inc.","Myerstown","PA","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Nationwide","F-0005-2014","Class II","Roasted Salted Mixed Nuts w/ Peanuts, net wt. 12 oz., packed in a clear plastic bag. Ingredients: blanched peanuts, unblanched peanuts, unblanched almonds, unblanched Brazil nuts, unblanched filberts, cashews cooked in canola oil, salt. Allergen info: peanut and tree nuts (almonds, Brazil nuts, filberts, cashews). Labeling also states that the facility also processes products containing tree nuts. Distributed by Dutch Valley Food Distributors Inc., Myerstown, PA 17067.","All products with UPC code 8 77245 00140 2 and Best By date up to 1/21/14. ",,,"Roasted Salted Mixed Nuts with Peanuts were recalled for undeclared tree nuts (pecans) in the ingredient statement. ",9/12/2013,"09/12/2013",10/23/2013,"10/23/2013"
"Devices",66293,"Ongoing","Bio-Rad Laboratories","Redmond","WA","US","Voluntary: Firm Initiated","Letter","US Distribution including the states of FL, IA, ME, MO, MS, NE, NY, TN, TX, and WA","Z-0032-2014","Class III","FSE Image Upgrade Kit, Catalog # 92019C This kit is used to install and/or upgrade software used with the EVOLIS Microplate System.","Lot 122822",".","23 kits","The FSE Image Upgrade kit (part 92019C) is recalled due to issue related to the export of data from the EVOLIS analyzer to Laboratory Information Systems (LIS) when using the MONOLISA Anti-HBs EIA Quantitative Determination in EVOLIS APF version 6.0.",8/20/2013,"08/20/2013",10/30/2013,"10/30/2013"
"Devices",66294,"Ongoing","Sekisui Diagnostics LLC","San Diego","CA","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Worldwide Distribution - US (nationwide) and the countries of UK, Saudi Arabia, Dubai, Kuwait, Poland, Spain, India and Romania","Z-0015-2014","Class II","Product Name: OSOM C. Difficile Toxin A/B Test Catalog Numbers: 173 (for United States) and 173 E (for Europe). The Test is a qualitative assay (in vitro diagnostic) that employs immunochromatographic, dipstick technology. If C. difficile toxin A or toxin B is present, a blue/gray line will appear in the test line region indicating a positive result. A red control line must appear for the results to be valid. If C. difficile toxins are not present, only the red control line will appear. An invalid test occurs when no control line appears The Test is intended for the qualitative detection of Clostridium difficile toxins A and/or B in human stool samples. This test is intended as an aid in the diagnosis of C.difficile associated disease (CDAD) in patients with symptoms of CDAD. ","The following are part numbers and lot number combinations. PN:173E, LN:121272. PN:173, LN:121273. PN:173, LN:121273A. PN:173E, LN:131155. PN:173, LN:131156.",,"391 kits","Sekisuki Diagnostics has issued a Product Correction for certain lot numbers of the OSOM C. difficile Toxin A/B Test Kit, because it has been determined that there is potential for false negative results.",9/16/2013,"09/16/2013",10/23/2013,"10/23/2013"
"Drugs",66295,"Ongoing","Hospira Inc.","Lake Forest","IL","US","Voluntary: Firm Initiated","Letter","Nationwide and Guam and Abu Dhabi","D-66295-001","Class II","0.5% Bupivacaine HCl and Epinephrine 1:200,000 Inj., 10 mL, Single-Dose Vial, NDC 0409-9045-01, Hospira, Inc., Lake Forest, IL 60045","Lot 17-400-EV* and 17-401-EV * Note: the lot number may be followed by 01",".","187,150 vials","Lack of Assurance of Sterility; potential for vial breakage",9/5/2013,"09/05/2013",10/16/2013,"10/16/2013"
"Devices",66296,"Ongoing","Philips Medical Systems (Cleveland) Inc","Cleveland","OH","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution - USA (nationwide) including Puerto Rico and the states of AR, AZ, CA, CO, CT, GA, HI, IL, IN, KS, MA, MD, MI, MO, MS, NC, NH, NJ, NV, NY, OH, OK, OR,TN, TX, UT, VA, VT and WV., and the countries of Australia, Austria, Bangladesh, Belgium, Brazil, Chile, China, Denmark, Egypt, France, Germany, Honduras, India, Indonesia, Italy, Kazakhstan, Latvia, Lebanon, Libyan Arab Jamahiriya, Mexico, Netherlands, Norway, Palestine, Philippines, Poland, Russia, Saudi Arabia, South Africa, South Korea, Spain, Sweden, Switzerland, Taiwan, Thailand, Turkey, Ukraine, United Kingdom and Vietnam.","Z-0013-2014","Class II","Brilliance CT Big Bore Oncology, Brilliance CT Big Bore Radiology and Brilliance CT 16 (Air) Brilliance CT Big Bore Oncology, Brilliance CT Big Bore Radiology and Brilliance CT 16 (Air) scanners are whole body Computed Tomography X-ray systems that are intended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission data taken at different angles and planes. These devices may include signal analysis and display equipment, patient and equipment supports, components and accessories. ","System Code #728243, Serial #: 7040, 7083, 7087, 7123, 7124, 7133, 7170, 7178, 7204, 7231, 7273, 7328, 7365, 7370, 7395, 7434, 7467, 7596, 7612, 7775, 7794, 7795, 7840, 7841, 7842, 7843, 7846, 7847, 7848, 7849, 7850, 7851, 7852, 7854, 7855, 7856, 7857, 7858, 7860, 7861, 7863, 7864, 7865, 7866, 7867, 7868, 7871, 7872, 7873, 7875, 7876, 7877, 7881, 7883, 7884, 7885, 7886, 7889, 7890, 7891, 7892, 7893, 7895, 7896, 7898, 7900, 7901, 7902, 7904, 7905, 7907, 7908, 7909, 7910, 7911, 7912, 7914, 7915, 7916, 7918, 7920, 7921, 7923, 7924, 7926, 7927, 7928, 7930, 7931, 7932, 7934, 7935, 7936, 7937, 7938, 7940, 7941, 7942, 7943, 7944 and 7945. System Code #728244, Serial #: 7121, 7271, 7764, 7844, 7845, 7853, 7859, 7862, 7869, 7870, 7874, 7878, 7879, 7880, 7882, 7887, 7888, 7894, 7897, 7899, 7903, 7906, 7913, 7917, 7919 and 7922. System Code #728246, Serial #: 3079, 3090, 3127, 3410, 3478, 3500, 3679, 3721, 5067, 5072, 5073, 5143, 5317, 5439, 5663, 5728, 5741, 5928, 5971, 6028, 6052, 6061, 6067, 6090, 6107, 6133, 6147, 6153, 6156, 6162, 6231, 6491, 6556, 6606, 6607, 6608, 6609, 6610, 6611, 6612, 6613, 6614, 6615, 6616, 6617, 6618, 6619, 6620, 6621, 6622, 6623, 6624, 6625, 6626, 6627, 6628, 6629, 6630, 6631, 6632, 6633, 6634, 6635, 6636, 6637, 6638, 6639, 6640, 6641, 6642, 6643, 6644, 6645, 6646, 6647, 6648, 6649, 6650, 6651, 6652, 6653, 6654, 6655, 6656, 6657, 6658, 6659, 6660, 6661, 6662, 6663, 6664, 6665, 6666, 6667, 6668, 6669, 6670, 6671, 6672, 6673, 6676, 6678, 6679, 6680, 6681, 6682, 6683, 6684, 6685, 6689, 6695, 6696, 6697, 6707, 6710, 6711, 6714, 6721, 30075, 40013, 50026, 50043, 50177, 50181, 50182, 50189, 50195, 50198, 50200 and 60009. ",,"258","There are artifacts appearing on the Tracker images during threshold-triggered bolus scans with protocols using a Rotation Time of 0.4 seconds.",8/30/2013,"08/30/2013",10/23/2013,"10/23/2013"
"Drugs",66297,"Completed","Triangle Compounding","Cary","NC","US","Voluntary: Firm Initiated","Telephone","NC","D-1069-2013","Class II","Histamine, 10 ng/mL Injectable, MDV, Rx only, Triangle Compounding Pharmacy, 3700 Regency Parkway, Suite 140, Cary NC 27518.","Lot 74651-LG4973, Exp 12/4/13",,"8 vials","Lack of Assurance of Sterility:The product lots are being recalled due to laboratory results (from a contract lab) indicating microbial contamination. The FDA was concerned test results obtained from the recalling firm's contract testing lab may not be reliable. Hence the sterility of the products cannot be assured. ",9/6/2013,"09/06/2013",10/9/2013,"10/09/2013"
"Drugs",66297,"Completed","Triangle Compounding","Cary","NC","US","Voluntary: Firm Initiated","Telephone","NC","D-1068-2013","Class II","Sodium Phosphate Injectable, 150mM/50mL Phosphorus 200mEq/50mL Sodium, 50 mL Single Dose Vial, Rx only, Triangle Compounding Pharmacy, 3700 Regency Parkway, Suite 140, Cary NC 27518.","Lot #814748-LG14917, Exp 10/31/13",,"54 Vials","Lack of Assurance of Sterility:The product lots are being recalled due to laboratory results (from a contract lab) indicating microbial contamination. The FDA was concerned test results obtained from the recalling firm's contract testing lab may not be reliable. Hence the sterility of the products cannot be assured. ",9/6/2013,"09/06/2013",10/9/2013,"10/09/2013"
"Devices",66300,"Ongoing","Ebi, Llc","Parsippany","NJ","US","Voluntary: Firm Initiated","Letter","Nationwide distribution including Puerto Rico.","Z-0359-2014","Class II","BIOMET Spine, Parsippany, NJ 07054. 5.5 TI 5.5x50mm Translation Screw Polaris 5.5 TI Spinal System. Rx Only. Non-Sterile. Intended for immobilization and stabilization as an adjunct to fusion as a pedicle screw fixation system","Multiple Item and Lot numbers.",,"7,092 units","Polaris Translation Screw Failures were recently reported to Biomet Spine. These failures are generally described as dissociation of the screw head from the shaft of the Polaris Translation Screw. ",8/22/2013,"08/22/2013",11/27/2013,"11/27/2013"
"Devices",66301,"Ongoing","Mckesson Information Solutions LLC","Alpharetta","GA","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution - United States including the territories of Guam and Puerto Rico and the countries of Canada and France.","Z-2318-2013","Class II","McKesson Horizon Medical Imaging (HMI) Radiological Image Processing System, product versions 4.6.1 to 11.6., is a medical image and information management application intended to receive, transmit, store, retrieve, display, print and process digital medical images, digital medical video, and associated medical information from medical imaging systems.","Products: HMI 4.6.1; HMI 5.x (5.0.1, 5.0.5, 5.0.6, 5.0.7, 5.0.8); HMI 11.0x (11.0.5, 11.0.6, 11.0.6 FR EP2, 11.0.7, 11.0.8); HMI 11.5x (11.5, 11.5.1, 11.5.2) and HMI 11.6.",,"329 units","Software malfunction may occur resulting in a certain combination of server configurations which has the potential to cause image loss.",9/4/2013,"09/04/2013",10/9/2013,"10/09/2013"
"Food",66302,"Terminated","Shenandoah Growers, Inc.","Harrisonburg","VA","US","Voluntary: Firm Initiated","E-Mail","Product was distributed to PA, VA and MD.","F-1914-2013","Class III","Fresh Herbs Everyday Basil, Shenandoah Growers brand, packaged in .75 oz; 2 oz.; and 2.5 oz. in 3 count and 6 count cardboard sleeves and labeled in part ***Shenandoah Growers Inc., Harrisonburg, Va 22802***","Lots: 50 143233; 50 243233; 50343233; and 50 443233",".","200 lbs","Fresh basil may be adulterated with pesticides.",8/23/2013,"08/23/2013",10/2/2013,"10/02/2013"
"Food",66302,"Terminated","Shenandoah Growers, Inc.","Harrisonburg","VA","US","Voluntary: Firm Initiated","E-Mail","Product was distributed to PA, VA and MD.","F-1915-2013","Class III","Basil, fresh, Giant brand, packaged in 2.5 oz. package and labeled in part ***Distributed by FoodHold USA Landover, MD 20785***","Lots: 50 143233; 50 243233; 50343233; and 50 443233",".","200 lbs total","Fresh basil may be adulterated with pesticides.",8/23/2013,"08/23/2013",10/2/2013,"10/02/2013"
"Food",66303,"Ongoing","Cakes & More Delight's","Trujillo Alto","PR","US","Voluntary: Firm Initiated","Telephone","PR only","F-0817-2014","Class III","Sugar free cake: Carrot flavor, Package size: 4 oz, 12 oz.","no codes",,"500 boxes (12 units each)","Lack of phenylketonuric warning in products containing aspartame.",9/10/2013,"09/10/2013",12/18/2013,"12/18/2013"
"Food",66303,"Ongoing","Cakes & More Delight's","Trujillo Alto","PR","US","Voluntary: Firm Initiated","Telephone","PR only","F-0821-2014","Class III","Sugar free cake: Corn. Package size: 4 oz, 12 oz","no codes",,"500 boxes total (12 units each)","Lack of phenylketonuric warning. The main ingredient ''Sugar Free RichCreme Base' contains aspartame.",9/10/2013,"09/10/2013",12/18/2013,"12/18/2013"
"Food",66303,"Ongoing","Cakes & More Delight's","Trujillo Alto","PR","US","Voluntary: Firm Initiated","Telephone","PR only","F-0820-2014","Class III","Sugar free cake: Pistachio flavor. Package size: 4 oz, 12 oz","no codes",,"500 boxes total (12 units each)","Lack of phenylketonuric warning. The main ingredient ''Sugar Free RichCreme Base' contains aspartame.",9/10/2013,"09/10/2013",12/18/2013,"12/18/2013"
"Food",66303,"Ongoing","Cakes & More Delight's","Trujillo Alto","PR","US","Voluntary: Firm Initiated","Telephone","PR only","F-0818-2014","Class III","Sliced Sugar free cake: almond flavor with cinnamon. Package size: 16 oz each.","no codes",,"20 boxes total","Lack of phenylketonuric warning. The main ingredient ''Sugar Free RichCreme Base' contains aspartame.",9/10/2013,"09/10/2013",12/18/2013,"12/18/2013"
"Food",66303,"Ongoing","Cakes & More Delight's","Trujillo Alto","PR","US","Voluntary: Firm Initiated","Telephone","PR only","F-0819-2014","Class III","Sugar free cake: Vanilla flavor. Package size: 4 oz, 12 oz; Sliced Sugar-free cake: Vanilla flavor 16 oz.","no codes",,"500 boxes total (12 units each)","Lack of phenylketonuric warning. The main ingredient ''Sugar Free RichCreme Base' contains aspartame.",9/10/2013,"09/10/2013",12/18/2013,"12/18/2013"
"Food",66303,"Ongoing","Cakes & More Delight's","Trujillo Alto","PR","US","Voluntary: Firm Initiated","Telephone","PR only","F-0822-2014","Class III","Sugar free cake: Almond flavor. Package size:12 oz","no codes",,"500 boxes total (12 units each)","Lack of phenylketonuric warning. The main ingredient ''Sugar Free RichCreme Base' contains aspartame.",9/10/2013,"09/10/2013",12/18/2013,"12/18/2013"
"Devices",66304,"Ongoing","Abbott Medical Optics, Inc.","Milpitas","CA","US","Voluntary: Firm Initiated","Letter","Worldwide distribution: US (nationwide) including Puerto Rico and countries of: Asia Pacific, Canada, Europe, Africa, Middle East, Japan, and Latin America.","Z-0048-2014","Class II","STAR Excimer Laser System with Variable Spot Scanning, Model: STAR S4, Catalog Number: 0030-4077, Product is manufactured and distributed by AMO Manufacturing USA, LLC, Milpitas, CA The STAR Excimer Laser Systems are indicated for laser assisted in situ keratomileusis (LASIK), photorefractive keratectomy (PRK), and phototherapeutic keratectomy (PTK) eye surgery in certain patient populations.","All units of these models: STAR S2 Excimer Laser System; STAR S3 ActiveTrak; STAR S4 with Variable Spot Scanning; and STAR S41R; There are no expiration dates for the STAR Excimer Laser Systems.",".","834 units in total","This corrective action will address an identified failure of the lamp and illumination system within the laser unit caused by an unexpected failure of a thyristor component on the AC Power Distribution Printed Circuit Board (PCB). ",9/16/2013,"09/16/2013",10/30/2013,"10/30/2013"
"Devices",66304,"Ongoing","Abbott Medical Optics, Inc.","Milpitas","CA","US","Voluntary: Firm Initiated","Letter","Worldwide distribution: US (nationwide) including Puerto Rico and countries of: Asia Pacific, Canada, Europe, Africa, Middle East, Japan, and Latin America.","Z-0049-2014","Class II","STAR Excimer Laser System, Model STAR S4 IR, Catalog Number: 0030-4864, Product is manufactured and distributed by AMO Manufacturing USA, LLC Milpitas, CA The STAR Excimer Laser Systems are indicated for laser assisted in situ keratomileusis (LASIK), photorefractive keratectomy (PRK), and phototherapeutic keratectomy (PTK) eye surgery in certain patient populations.","All units of these models: STAR S2 Excimer Laser System; STAR S3 ActiveTrak; STAR S4 with Variable Spot Scanning; and STAR S41R; There are no expiration dates for the STAR Excimer Laser Systems.",".","834 units in total","This corrective action will address an identified failure of the lamp and illumination system within the laser unit caused by an unexpected failure of a thyristor component on the AC Power Distribution Printed Circuit Board (PCB). ",9/16/2013,"09/16/2013",10/30/2013,"10/30/2013"
"Devices",66304,"Ongoing","Abbott Medical Optics, Inc.","Milpitas","CA","US","Voluntary: Firm Initiated","Letter","Worldwide distribution: US (nationwide) including Puerto Rico and countries of: Asia Pacific, Canada, Europe, Africa, Middle East, Japan, and Latin America.","Z-0046-2014","Class II","STAR Excimer Laser System, Model: STAR S2, Catalog Number: 0030-1479, Product is manufactured and distributed by AMO Manufacturing USA, LLC, Milpitas, CA The STAR Excimer Laser Systems are indicated for laser assisted in situ keratomileusis (LASIK), photorefractive keratectomy (PRK), and phototherapeutic keratectomy (PTK) eye surgery in certain patient populations.","All units of these models: STAR S2 Excimer Laser System; STAR S3 ActiveTrak; STAR S4 with Variable Spot Scanning; and STAR S41R; There are no expiration dates for the STAR Excimer Laser Systems.",".","834 units in total","This corrective action will address an identified failure of the lamp and illumination system within the laser unit caused by an unexpected failure of a thyristor component on the AC Power Distribution Printed Circuit Board (PCB). ",9/16/2013,"09/16/2013",10/30/2013,"10/30/2013"
"Devices",66304,"Ongoing","Abbott Medical Optics, Inc.","Milpitas","CA","US","Voluntary: Firm Initiated","Letter","Worldwide distribution: US (nationwide) including Puerto Rico and countries of: Asia Pacific, Canada, Europe, Africa, Middle East, Japan, and Latin America.","Z-0047-2014","Class II","STAR ActiveTrak Excimer Laser System, Model: STAR S3, Catalog Number: 0030-2450, Product is manufactured and distributed by AMO Manufacturing USA, LLC, Milpitas, CA The STAR Excimer Laser Systems are indicated for laser assisted in situ keratomileusis (LASIK), photorefractive keratectomy (PRK), and phototherapeutic keratectomy (PTK) eye surgery in certain patient populations.","All units of these models: STAR S2 Excimer Laser System; STAR S3 ActiveTrak; STAR S4 with Variable Spot Scanning; and STAR S41R; There are no expiration dates for the STAR Excimer Laser Systems.",".","834 units in total ","This corrective action will address an identified failure of the lamp and illumination system within the laser unit caused by an unexpected failure of a thyristor component on the AC Power Distribution Printed Circuit Board (PCB). ",9/16/2013,"09/16/2013",10/30/2013,"10/30/2013"
"Devices",66305,"Ongoing","Edwards Lifesciences, LLC","Draper","UT","US","Voluntary: Firm Initiated","Letter","Worldwide distribution: US (nationwide) and country of: Canada.","Z-0091-2014","Class I","Edwards Lifesciences EMBOL-X Glide Protection System; Model Numbers: EXGF24D, EXGF24LLD, EXGF24MMD, EXGF24SSD, EXGF24XLD, EXGF24XSD, EXGFXS2D, EXGF24SS2D, EXGF24MM2D, EXGF24LL2D and EXGF24XL2D. The EMBOL-X access device is indicated for the perfusion of the ascending aorta during short-term (less than or equal to0 6 hours) cardiopulmonary bypass (CPB) surgery where procedures may require the hemostatic introduction and removal of compatible intravascular devices into the vascular system.","Model No: EXGF24D, EXGF24LLD, EXGF24MMD, EXGF24SSD, EXGF24XLD, EXGF24XSD, EXGFXS2D, EXGF24SS2D, EXGF24MM2D, EXGF24LL2D and EXGF24XL2D.",,"12,034","Edwards Lifesciences is recalling certain lots of EMBOL-X Glide Protection System due to deformation of the cannula tip.",9/16/2013,"09/16/2013",11/6/2013,"11/06/2013"
"Devices",66306,"Ongoing","Carestream Health Inc.","Rochester","NY","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution - USA including AR, AZ, CA, CO, CT, FL, IA, IL, MA, MD, ME, MN, MO, NC, NH, NV, NY, OH, OK, PA, RI, TN, UT, VA WA, and WI and Internationally to Canada, Japan, and Kuwait.","Z-0259-2014","Class II","Carestream Vue PACS; UPG MX-RAD SVR 50K EX/YR UNLIMITED The CARESTREAM PACS is an image management system whose intended use is to provide completely scaleable local and wide area PACS solutions for hospital and related institutions/sites, which will archive, distribute, retrieve and display images and data from all hospital modalities and information systems.","Model: Vue PACS client version 11.3.2.0 / 11.3.2.4 / 11.4 Catalog Number: 8441602",".",,"Carestream Health, Inc. has issued a recall when using the CARESTREAM Client Workstation where under very specific conditions, some images from multi-slice studies such as CT and MR may not load into the viewer application due to a software problem. ",9/16/2013,"09/16/2013",11/20/2013,"11/20/2013"
"Devices",66306,"Ongoing","Carestream Health Inc.","Rochester","NY","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution - USA including AR, AZ, CA, CO, CT, FL, IA, IL, MA, MD, ME, MN, MO, NC, NH, NV, NY, OH, OK, PA, RI, TN, UT, VA WA, and WI and Internationally to Canada, Japan, and Kuwait.","Z-0231-2014","Class II","Carestream Vue PACS; MX-O SA WORKSTATION SW LICENSE The CARESTREAM PACS is an image management system whose intended use is to provide completely scaleable local and wide area PACS solutions for hospital and related institutions/sites, which will archive, distribute, retrieve and display images and data from all hospital modalities and information systems.","Model: Vue PACS client version 11.3.2.0 / 11.3.2.4 / 11.4 Catalog Number: 8978504",".",,"Carestream Health, Inc. has issued a recall when using the CARESTREAM Client Workstation where under very specific conditions, some images from multi-slice studies such as CT and MR may not load into the viewer application due to a software problem. ",9/16/2013,"09/16/2013",11/20/2013,"11/20/2013"
"Devices",66306,"Ongoing","Carestream Health Inc.","Rochester","NY","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution - USA including AR, AZ, CA, CO, CT, FL, IA, IL, MA, MD, ME, MN, MO, NC, NH, NV, NY, OH, OK, PA, RI, TN, UT, VA WA, and WI and Internationally to Canada, Japan, and Kuwait.","Z-0244-2014","Class II","Carestream Vue PACS; UPG MX-O SVR 25K EX/YR UNLIMITED The CARESTREAM PACS is an image management system whose intended use is to provide completely scaleable local and wide area PACS solutions for hospital and related institutions/sites, which will archive, distribute, retrieve and display images and data from all hospital modalities and information systems.","Model: Vue PACS client version 11.3.2.0 / 11.3.2.4 / 11.4 Catalog Number: 8711459",".",,"Carestream Health, Inc. has issued a recall when using the CARESTREAM Client Workstation where under very specific conditions, some images from multi-slice studies such as CT and MR may not load into the viewer application due to a software problem. ",9/16/2013,"09/16/2013",11/20/2013,"11/20/2013"
"Devices",66306,"Ongoing","Carestream Health Inc.","Rochester","NY","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution - USA including AR, AZ, CA, CO, CT, FL, IA, IL, MA, MD, ME, MN, MO, NC, NH, NV, NY, OH, OK, PA, RI, TN, UT, VA WA, and WI and Internationally to Canada, Japan, and Kuwait.","Z-0232-2014","Class II","Carestream Vue PACS; MX CLINIC SOFTWARE DICOM VIEWING The CARESTREAM PACS is an image management system whose intended use is to provide completely scaleable local and wide area PACS solutions for hospital and related institutions/sites, which will archive, distribute, retrieve and display images and data from all hospital modalities and information systems.","Model: Vue PACS client version 11.3.2.0 / 11.3.2.4 / 11.4 Catalog Number: 1384700",".",,"Carestream Health, Inc. has issued a recall when using the CARESTREAM Client Workstation where under very specific conditions, some images from multi-slice studies such as CT and MR may not load into the viewer application due to a software problem. ",9/16/2013,"09/16/2013",11/20/2013,"11/20/2013"
"Devices",66306,"Ongoing","Carestream Health Inc.","Rochester","NY","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution - USA including AR, AZ, CA, CO, CT, FL, IA, IL, MA, MD, ME, MN, MO, NC, NH, NV, NY, OH, OK, PA, RI, TN, UT, VA WA, and WI and Internationally to Canada, Japan, and Kuwait.","Z-0237-2014","Class II","Carestream Vue PACS; MX WEB SVR W/3 MX-O LIC < 25K EXAMS The CARESTREAM PACS is an image management system whose intended use is to provide completely scaleable local and wide area PACS solutions for hospital and related institutions/sites, which will archive, distribute, retrieve and display images and data from all hospital modalities and information systems.","Model: Vue PACS client version 11.3.2.0 / 11.3.2.4 / 11.4 Catalog Number: 1961382",".",,"Carestream Health, Inc. has issued a recall when using the CARESTREAM Client Workstation where under very specific conditions, some images from multi-slice studies such as CT and MR may not load into the viewer application due to a software problem. ",9/16/2013,"09/16/2013",11/20/2013,"11/20/2013"
"Devices",66306,"Ongoing","Carestream Health Inc.","Rochester","NY","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution - USA including AR, AZ, CA, CO, CT, FL, IA, IL, MA, MD, ME, MN, MO, NC, NH, NV, NY, OH, OK, PA, RI, TN, UT, VA WA, and WI and Internationally to Canada, Japan, and Kuwait.","Z-0226-2014","Class II","Carestream Vue PACS; UNLIMITED READING LIC < 25K EX/YR The CARESTREAM PACS is an image management system whose intended use is to provide completely scaleable local and wide area PACS solutions for hospital and related institutions/sites, which will archive, distribute, retrieve and display images and data from all hospital modalities and information systems.","Model: Vue PACS client version 11.3.2.0 / 11.3.2.4 / 11.4 Catalog Number: 1149418",".",,"Carestream Health, Inc. has issued a recall when using the CARESTREAM Client Workstation where under very specific conditions, some images from multi-slice studies such as CT and MR may not load into the viewer application due to a software problem. ",9/16/2013,"09/16/2013",11/20/2013,"11/20/2013"
"Devices",66306,"Ongoing","Carestream Health Inc.","Rochester","NY","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution - USA including AR, AZ, CA, CO, CT, FL, IA, IL, MA, MD, ME, MN, MO, NC, NH, NV, NY, OH, OK, PA, RI, TN, UT, VA WA, and WI and Internationally to Canada, Japan, and Kuwait.","Z-0247-2014","Class II","Carestream Vue PACS; MX WEB SW/ 1 MX-O CONCUR ACCESS LIC The CARESTREAM PACS is an image management system whose intended use is to provide completely scaleable local and wide area PACS solutions for hospital and related institutions/sites, which will archive, distribute, retrieve and display images and data from all hospital modalities and information systems.","Model: Vue PACS client version 11.3.2.0 / 11.3.2.4 / 11.4 Catalog Number: 1482116",".",,"Carestream Health, Inc. has issued a recall when using the CARESTREAM Client Workstation where under very specific conditions, some images from multi-slice studies such as CT and MR may not load into the viewer application due to a software problem. ",9/16/2013,"09/16/2013",11/20/2013,"11/20/2013"
"Devices",66306,"Ongoing","Carestream Health Inc.","Rochester","NY","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution - USA including AR, AZ, CA, CO, CT, FL, IA, IL, MA, MD, ME, MN, MO, NC, NH, NV, NY, OH, OK, PA, RI, TN, UT, VA WA, and WI and Internationally to Canada, Japan, and Kuwait.","Z-0248-2014","Class II","Carestream Vue PACS; MX WEB SVR W/3 MX-RAD LIC<75K EX/YR The CARESTREAM PACS is an image management system whose intended use is to provide completely scaleable local and wide area PACS solutions for hospital and related institutions/sites, which will archive, distribute, retrieve and display images and data from all hospital modalities and information systems.","Model: Vue PACS client version 11.3.2.0 / 11.3.2.4 / 11.4 Catalog Number: 8274888",".",,"Carestream Health, Inc. has issued a recall when using the CARESTREAM Client Workstation where under very specific conditions, some images from multi-slice studies such as CT and MR may not load into the viewer application due to a software problem. ",9/16/2013,"09/16/2013",11/20/2013,"11/20/2013"
"Devices",66306,"Ongoing","Carestream Health Inc.","Rochester","NY","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution - USA including AR, AZ, CA, CO, CT, FL, IA, IL, MA, MD, ME, MN, MO, NC, NH, NV, NY, OH, OK, PA, RI, TN, UT, VA WA, and WI and Internationally to Canada, Japan, and Kuwait.","Z-0242-2014","Class II","Carestream Vue PACS; UPG MX-O SVR 25K EX/YR UNLIMITED The CARESTREAM PACS is an image management system whose intended use is to provide completely scaleable local and wide area PACS solutions for hospital and related institutions/sites, which will archive, distribute, retrieve and display images and data from all hospital modalities and information systems.","Model: Vue PACS client version 11.3.2.0 / 11.3.2.4 / 11.4 Catalog Number: 8711459",".",,"Carestream Health, Inc. has issued a recall when using the CARESTREAM Client Workstation where under very specific conditions, some images from multi-slice studies such as CT and MR may not load into the viewer application due to a software problem. ",9/16/2013,"09/16/2013",11/20/2013,"11/20/2013"
"Devices",66306,"Ongoing","Carestream Health Inc.","Rochester","NY","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution - USA including AR, AZ, CA, CO, CT, FL, IA, IL, MA, MD, ME, MN, MO, NC, NH, NV, NY, OH, OK, PA, RI, TN, UT, VA WA, and WI and Internationally to Canada, Japan, and Kuwait.","Z-0228-2014","Class II","Carestream Vue PACS; UNLIMITED READING LIC ADD 10K EX/YR The CARESTREAM PACS is an image management system whose intended use is to provide completely scaleable local and wide area PACS solutions for hospital and related institutions/sites, which will archive, distribute, retrieve and display images and data from all hospital modalities and information systems.","Model: Vue PACS client version 11.3.2.0 / 11.3.2.4 / 11.4 Catalog Number: 8976268",".",,"Carestream Health, Inc. has issued a recall when using the CARESTREAM Client Workstation where under very specific conditions, some images from multi-slice studies such as CT and MR may not load into the viewer application due to a software problem. ",9/16/2013,"09/16/2013",11/20/2013,"11/20/2013"
"Devices",66306,"Ongoing","Carestream Health Inc.","Rochester","NY","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution - USA including AR, AZ, CA, CO, CT, FL, IA, IL, MA, MD, ME, MN, MO, NC, NH, NV, NY, OH, OK, PA, RI, TN, UT, VA WA, and WI and Internationally to Canada, Japan, and Kuwait.","Z-0260-2014","Class II","Carestream Vue PACS; UPG MX-RAD SVR 75K EX/YR UNLIMITED The CARESTREAM PACS is an image management system whose intended use is to provide completely scaleable local and wide area PACS solutions for hospital and related institutions/sites, which will archive, distribute, retrieve and display images and data from all hospital modalities and information systems.","Model: Vue PACS client version 11.3.2.0 / 11.3.2.4 / 11.4 Catalog Number: 8553331",".",,"Carestream Health, Inc. has issued a recall when using the CARESTREAM Client Workstation where under very specific conditions, some images from multi-slice studies such as CT and MR may not load into the viewer application due to a software problem. ",9/16/2013,"09/16/2013",11/20/2013,"11/20/2013"
"Devices",66306,"Ongoing","Carestream Health Inc.","Rochester","NY","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution - USA including AR, AZ, CA, CO, CT, FL, IA, IL, MA, MD, ME, MN, MO, NC, NH, NV, NY, OH, OK, PA, RI, TN, UT, VA WA, and WI and Internationally to Canada, Japan, and Kuwait.","Z-0220-2014","Class II","Carestream Vue PACS; Virtual PWR Reading Basic SW StandAlone The CARESTREAM PACS is an image management system whose intended use is to provide completely scaleable local and wide area PACS solutions for hospital and related institutions/sites, which will archive, distribute, retrieve and display images and data from all hospital modalities and information systems.","Model: Vue PACS client version 11.3.2.0 / 11.3.2.4 / 11.4 Catalog Number: 8230633",".",,"Carestream Health, Inc. has issued a recall when using the CARESTREAM Client Workstation where under very specific conditions, some images from multi-slice studies such as CT and MR may not load into the viewer application due to a software problem. ",9/16/2013,"09/16/2013",11/20/2013,"11/20/2013"
"Devices",66306,"Ongoing","Carestream Health Inc.","Rochester","NY","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution - USA including AR, AZ, CA, CO, CT, FL, IA, IL, MA, MD, ME, MN, MO, NC, NH, NV, NY, OH, OK, PA, RI, TN, UT, VA WA, and WI and Internationally to Canada, Japan, and Kuwait.","Z-0225-2014","Class II","Carestream Vue PACS; MX WEB SVR W/3 MX-RAD LIC<15K EXAMS The CARESTREAM PACS is an image management system whose intended use is to provide completely scaleable local and wide area PACS solutions for hospital and related institutions/sites, which will archive, distribute, retrieve and display images and data from all hospital modalities and information systems.","Model: Vue PACS client version 11.3.2.0 / 11.3.2.4 / 11.4 Catalog Number: 8656456",".",,"Carestream Health, Inc. has issued a recall when using the CARESTREAM Client Workstation where under very specific conditions, some images from multi-slice studies such as CT and MR may not load into the viewer application due to a software problem. ",9/16/2013,"09/16/2013",11/20/2013,"11/20/2013"
"Devices",66306,"Ongoing","Carestream Health Inc.","Rochester","NY","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution - USA including AR, AZ, CA, CO, CT, FL, IA, IL, MA, MD, ME, MN, MO, NC, NH, NV, NY, OH, OK, PA, RI, TN, UT, VA WA, and WI and Internationally to Canada, Japan, and Kuwait.","Z-0213-2014","Class II","Carestream Vue PACS; Virtual PWR Reading Basic SW, Workgroup The CARESTREAM PACS is an image management system whose intended use is to provide completely scaleable local and wide area PACS solutions for hospital and related institutions/sites, which will archive, distribute, retrieve and display images and data from all hospital modalities and information systems.","Model: Vue PACS client version 11.3.2.0 / 11.3.2.4 / 11.4 Catalog Number: 1308519",".",,"Carestream Health, Inc. has issued a recall when using the CARESTREAM Client Workstation where under very specific conditions, some images from multi-slice studies such as CT and MR may not load into the viewer application due to a software problem. ",9/16/2013,"09/16/2013",11/20/2013,"11/20/2013"
"Devices",66306,"Ongoing","Carestream Health Inc.","Rochester","NY","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution - USA including AR, AZ, CA, CO, CT, FL, IA, IL, MA, MD, ME, MN, MO, NC, NH, NV, NY, OH, OK, PA, RI, TN, UT, VA WA, and WI and Internationally to Canada, Japan, and Kuwait.","Z-0234-2014","Class II","Carestream Vue PACS; MX PRINT SW AUTO LAYOUT PAGE & PRINT The CARESTREAM PACS is an image management system whose intended use is to provide completely scaleable local and wide area PACS solutions for hospital and related institutions/sites, which will archive, distribute, retrieve and display images and data from all hospital modalities and information systems.","Model: Vue PACS client version 11.3.2.0 / 11.3.2.4 / 11.4 Catalog Number: 8678468",".",,"Carestream Health, Inc. has issued a recall when using the CARESTREAM Client Workstation where under very specific conditions, some images from multi-slice studies such as CT and MR may not load into the viewer application due to a software problem. ",9/16/2013,"09/16/2013",11/20/2013,"11/20/2013"
"Devices",66306,"Ongoing","Carestream Health Inc.","Rochester","NY","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution - USA including AR, AZ, CA, CO, CT, FL, IA, IL, MA, MD, ME, MN, MO, NC, NH, NV, NY, OH, OK, PA, RI, TN, UT, VA WA, and WI and Internationally to Canada, Japan, and Kuwait.","Z-0251-2014","Class II","Carestream Vue PACS; MX WEB SW/1 MX-RAD CONCUR USER LIC The CARESTREAM PACS is an image management system whose intended use is to provide completely scaleable local and wide area PACS solutions for hospital and related institutions/sites, which will archive, distribute, retrieve and display images and data from all hospital modalities and information systems.","Model: Vue PACS client version 11.3.2.0 / 11.3.2.4 / 11.4 Catalog Number: 1849592",".",,"Carestream Health, Inc. has issued a recall when using the CARESTREAM Client Workstation where under very specific conditions, some images from multi-slice studies such as CT and MR may not load into the viewer application due to a software problem. ",9/16/2013,"09/16/2013",11/20/2013,"11/20/2013"
"Devices",66306,"Ongoing","Carestream Health Inc.","Rochester","NY","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution - USA including AR, AZ, CA, CO, CT, FL, IA, IL, MA, MD, ME, MN, MO, NC, NH, NV, NY, OH, OK, PA, RI, TN, UT, VA WA, and WI and Internationally to Canada, Japan, and Kuwait.","Z-0222-2014","Class II","Carestream Vue PACS; Unlimited Reading LIC<7.5K EX/YR The CARESTREAM PACS is an image management system whose intended use is to provide completely scaleable local and wide area PACS solutions for hospital and related institutions/sites, which will archive, distribute, retrieve and display images and data from all hospital modalities and information systems.","Model: Vue PACS client version 11.3.2.0 / 11.3.2.4 / 11.4 Catalog Number: 8380354",".",,"Carestream Health, Inc. has issued a recall when using the CARESTREAM Client Workstation where under very specific conditions, some images from multi-slice studies such as CT and MR may not load into the viewer application due to a software problem. ",9/16/2013,"09/16/2013",11/20/2013,"11/20/2013"
"Devices",66306,"Ongoing","Carestream Health Inc.","Rochester","NY","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution - USA including AR, AZ, CA, CO, CT, FL, IA, IL, MA, MD, ME, MN, MO, NC, NH, NV, NY, OH, OK, PA, RI, TN, UT, VA WA, and WI and Internationally to Canada, Japan, and Kuwait.","Z-0221-2014","Class II","Carestream Vue PACS; Virtual Reading Basic SW StandAlone The CARESTREAM PACS is an image management system whose intended use is to provide completely scaleable local and wide area PACS solutions for hospital and related institutions/sites, which will archive, distribute, retrieve and display images and data from all hospital modalities and information systems.","Model: Vue PACS client version 11.3.2.0 / 11.3.2.4 / 11.4 Catalog Number: 1097229",".",,"Carestream Health, Inc. has issued a recall when using the CARESTREAM Client Workstation where under very specific conditions, some images from multi-slice studies such as CT and MR may not load into the viewer application due to a software problem. ",9/16/2013,"09/16/2013",11/20/2013,"11/20/2013"
"Devices",66306,"Ongoing","Carestream Health Inc.","Rochester","NY","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution - USA including AR, AZ, CA, CO, CT, FL, IA, IL, MA, MD, ME, MN, MO, NC, NH, NV, NY, OH, OK, PA, RI, TN, UT, VA WA, and WI and Internationally to Canada, Japan, and Kuwait.","Z-0258-2014","Class II","Carestream Vue PACS; UPG MX-RAD SVR 25K EX/YR UNLIMITED The CARESTREAM PACS is an image management system whose intended use is to provide completely scaleable local and wide area PACS solutions for hospital and related institutions/sites, which will archive, distribute, retrieve and display images and data from all hospital modalities and information systems.","Model: Vue PACS client version 11.3.2.0 / 11.3.2.4 / 11.4 Catalog Number: 8296642",".",,"Carestream Health, Inc. has issued a recall when using the CARESTREAM Client Workstation where under very specific conditions, some images from multi-slice studies such as CT and MR may not load into the viewer application due to a software problem. ",9/16/2013,"09/16/2013",11/20/2013,"11/20/2013"
"Devices",66306,"Ongoing","Carestream Health Inc.","Rochester","NY","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution - USA including AR, AZ, CA, CO, CT, FL, IA, IL, MA, MD, ME, MN, MO, NC, NH, NV, NY, OH, OK, PA, RI, TN, UT, VA WA, and WI and Internationally to Canada, Japan, and Kuwait.","Z-0214-2014","Class II","Carestream Vue PACS; Virtual PWR Reading Basic SW, 8 Pack The CARESTREAM PACS is an image management system whose intended use is to provide completely scaleable local and wide area PACS solutions for hospital and related institutions/sites, which will archive, distribute, retrieve and display images and data from all hospital modalities and information systems.","Model: Vue PACS client version 11.3.2.0 / 11.3.2.4 / 11.4 Catalog Number: 1530633",".",,"Carestream Health, Inc. has issued a recall when using the CARESTREAM Client Workstation where under very specific conditions, some images from multi-slice studies such as CT and MR may not load into the viewer application due to a software problem. ",9/16/2013,"09/16/2013",11/20/2013,"11/20/2013"
"Devices",66306,"Ongoing","Carestream Health Inc.","Rochester","NY","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution - USA including AR, AZ, CA, CO, CT, FL, IA, IL, MA, MD, ME, MN, MO, NC, NH, NV, NY, OH, OK, PA, RI, TN, UT, VA WA, and WI and Internationally to Canada, Japan, and Kuwait.","Z-0223-2014","Class II","Carestream Vue PACS; Unlimited Reading LIC<15K EX/YR The CARESTREAM PACS is an image management system whose intended use is to provide completely scaleable local and wide area PACS solutions for hospital and related institutions/sites, which will archive, distribute, retrieve and display images and data from all hospital modalities and information systems.","Model: Vue PACS client version 11.3.2.0 / 11.3.2.4 / 11.4 Catalog Number: 8648503",".",,"Carestream Health, Inc. has issued a recall when using the CARESTREAM Client Workstation where under very specific conditions, some images from multi-slice studies such as CT and MR may not load into the viewer application due to a software problem. ",9/16/2013,"09/16/2013",11/20/2013,"11/20/2013"
"Devices",66306,"Ongoing","Carestream Health Inc.","Rochester","NY","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution - USA including AR, AZ, CA, CO, CT, FL, IA, IL, MA, MD, ME, MN, MO, NC, NH, NV, NY, OH, OK, PA, RI, TN, UT, VA WA, and WI and Internationally to Canada, Japan, and Kuwait.","Z-0216-2014","Class II","Carestream Vue PACS; Virtual PWR Reading Basic SW 8 Pack The CARESTREAM PACS is an image management system whose intended use is to provide completely scaleable local and wide area PACS solutions for hospital and related institutions/sites, which will archive, distribute, retrieve and display images and data from all hospital modalities and information systems.","Model: Vue PACS client version 11.3.2.0 / 11.3.2.4 / 11.4 Catalog Number: 1405794",".",,"Carestream Health, Inc. has issued a recall when using the CARESTREAM Client Workstation where under very specific conditions, some images from multi-slice studies such as CT and MR may not load into the viewer application due to a software problem. ",9/16/2013,"09/16/2013",11/20/2013,"11/20/2013"
"Devices",66306,"Ongoing","Carestream Health Inc.","Rochester","NY","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution - USA including AR, AZ, CA, CO, CT, FL, IA, IL, MA, MD, ME, MN, MO, NC, NH, NV, NY, OH, OK, PA, RI, TN, UT, VA WA, and WI and Internationally to Canada, Japan, and Kuwait.","Z-0243-2014","Class II","Carestream Vue PACS; UPG MX-O SVR 15K EX/YR UNLIMITED The CARESTREAM PACS is an image management system whose intended use is to provide completely scaleable local and wide area PACS solutions for hospital and related institutions/sites, which will archive, distribute, retrieve and display images and data from all hospital modalities and information systems.","Model: Vue PACS client version 11.3.2.0 / 11.3.2.4 / 11.4 Catalog Number: 8485021",".",,"Carestream Health, Inc. has issued a recall when using the CARESTREAM Client Workstation where under very specific conditions, some images from multi-slice studies such as CT and MR may not load into the viewer application due to a software problem. ",9/16/2013,"09/16/2013",11/20/2013,"11/20/2013"
"Devices",66306,"Ongoing","Carestream Health Inc.","Rochester","NY","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution - USA including AR, AZ, CA, CO, CT, FL, IA, IL, MA, MD, ME, MN, MO, NC, NH, NV, NY, OH, OK, PA, RI, TN, UT, VA WA, and WI and Internationally to Canada, Japan, and Kuwait.","Z-0250-2014","Class II","Carestream Vue PACS; MX WEB SVR W/3 MX-RAD LIC<25K EXAMS The CARESTREAM PACS is an image management system whose intended use is to provide completely scaleable local and wide area PACS solutions for hospital and related institutions/sites, which will archive, distribute, retrieve and display images and data from all hospital modalities and information systems.","Model: Vue PACS client version 11.3.2.0 / 11.3.2.4 / 11.4 Catalog Number: 8446361",".",,"Carestream Health, Inc. has issued a recall when using the CARESTREAM Client Workstation where under very specific conditions, some images from multi-slice studies such as CT and MR may not load into the viewer application due to a software problem. ",9/16/2013,"09/16/2013",11/20/2013,"11/20/2013"
"Devices",66306,"Ongoing","Carestream Health Inc.","Rochester","NY","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution - USA including AR, AZ, CA, CO, CT, FL, IA, IL, MA, MD, ME, MN, MO, NC, NH, NV, NY, OH, OK, PA, RI, TN, UT, VA WA, and WI and Internationally to Canada, Japan, and Kuwait.","Z-0212-2014","Class II","Carestream Vue PACS; Virtual Access Plus SW, Workgroup The CARESTREAM PACS is an image management system whose intended use is to provide completely scaleable local and wide area PACS solutions for hospital and related institutions/sites, which will archive, distribute, retrieve and display images and data from all hospital modalities and information systems.","Model: Vue PACS client version 11.3.2.0 / 11.3.2.4 / 11.4 Catalog Number: 1013226",".",,"Carestream Health, Inc. has issued a recall when using the CARESTREAM Client Workstation where under very specific conditions, some images from multi-slice studies such as CT and MR may not load into the viewer application due to a software problem. ",9/16/2013,"09/16/2013",11/20/2013,"11/20/2013"
"Devices",66306,"Ongoing","Carestream Health Inc.","Rochester","NY","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution - USA including AR, AZ, CA, CO, CT, FL, IA, IL, MA, MD, ME, MN, MO, NC, NH, NV, NY, OH, OK, PA, RI, TN, UT, VA WA, and WI and Internationally to Canada, Japan, and Kuwait.","Z-0240-2014","Class II","Carestream Vue PACS; UPG MX-O SVR 7.5K EX/YR UNLIMITED The CARESTREAM PACS is an image management system whose intended use is to provide completely scaleable local and wide area PACS solutions for hospital and related institutions/sites, which will archive, distribute, retrieve and display images and data from all hospital modalities and information systems.","Model: Vue PACS client version 11.3.2.0 / 11.3.2.4 / 11.4 Catalog Number: 8215956",".",,"Carestream Health, Inc. has issued a recall when using the CARESTREAM Client Workstation where under very specific conditions, some images from multi-slice studies such as CT and MR may not load into the viewer application due to a software problem. ",9/16/2013,"09/16/2013",11/20/2013,"11/20/2013"
"Devices",66306,"Ongoing","Carestream Health Inc.","Rochester","NY","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution - USA including AR, AZ, CA, CO, CT, FL, IA, IL, MA, MD, ME, MN, MO, NC, NH, NV, NY, OH, OK, PA, RI, TN, UT, VA WA, and WI and Internationally to Canada, Japan, and Kuwait.","Z-0254-2014","Class II","Carestream Vue PACS; MX WEB SW/15 MX-RAD CONCUR USER LIC The CARESTREAM PACS is an image management system whose intended use is to provide completely scaleable local and wide area PACS solutions for hospital and related institutions/sites, which will archive, distribute, retrieve and display images and data from all hospital modalities and information systems.","Model: Vue PACS client version 11.3.2.0 / 11.3.2.4 / 11.4 Catalog Number: 1387042",".",,"Carestream Health, Inc. has issued a recall when using the CARESTREAM Client Workstation where under very specific conditions, some images from multi-slice studies such as CT and MR may not load into the viewer application due to a software problem. ",9/16/2013,"09/16/2013",11/20/2013,"11/20/2013"
"Devices",66306,"Ongoing","Carestream Health Inc.","Rochester","NY","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution - USA including AR, AZ, CA, CO, CT, FL, IA, IL, MA, MD, ME, MN, MO, NC, NH, NV, NY, OH, OK, PA, RI, TN, UT, VA WA, and WI and Internationally to Canada, Japan, and Kuwait.","Z-0253-2014","Class II","Carestream Vue PACS; MX WEB SW/10 MX-RAD CONCUR USER LIC The CARESTREAM PACS is an image management system whose intended use is to provide completely scaleable local and wide area PACS solutions for hospital and related institutions/sites, which will archive, distribute, retrieve and display images and data from all hospital modalities and information systems.","Model: Vue PACS client version 11.3.2.0 / 11.3.2.4 / 11.4 Catalog Number: 8795866",".",,"Carestream Health, Inc. has issued a recall when using the CARESTREAM Client Workstation where under very specific conditions, some images from multi-slice studies such as CT and MR may not load into the viewer application due to a software problem. ",9/16/2013,"09/16/2013",11/20/2013,"11/20/2013"
"Devices",66306,"Ongoing","Carestream Health Inc.","Rochester","NY","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution - USA including AR, AZ, CA, CO, CT, FL, IA, IL, MA, MD, ME, MN, MO, NC, NH, NV, NY, OH, OK, PA, RI, TN, UT, VA WA, and WI and Internationally to Canada, Japan, and Kuwait.","Z-0246-2014","Class II","Carestream Vue PACS; UPG MX-O SVR 75K EX/YR UNLIMITED The CARESTREAM PACS is an image management system whose intended use is to provide completely scaleable local and wide area PACS solutions for hospital and related institutions/sites, which will archive, distribute, retrieve and display images and data from all hospital modalities and information systems.","Model: Vue PACS client version 11.3.2.0 / 11.3.2.4 / 11.4 Catalog Number: 886578",".",,"Carestream Health, Inc. has issued a recall when using the CARESTREAM Client Workstation where under very specific conditions, some images from multi-slice studies such as CT and MR may not load into the viewer application due to a software problem. ",9/16/2013,"09/16/2013",11/20/2013,"11/20/2013"
"Devices",66306,"Ongoing","Carestream Health Inc.","Rochester","NY","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution - USA including AR, AZ, CA, CO, CT, FL, IA, IL, MA, MD, ME, MN, MO, NC, NH, NV, NY, OH, OK, PA, RI, TN, UT, VA WA, and WI and Internationally to Canada, Japan, and Kuwait.","Z-0233-2014","Class II","Carestream Vue PACS; MX RAD SW ADV CR/DR LAYOUT & VIEW The CARESTREAM PACS is an image management system whose intended use is to provide completely scaleable local and wide area PACS solutions for hospital and related institutions/sites, which will archive, distribute, retrieve and display images and data from all hospital modalities and information systems.","Model: Vue PACS client version 11.3.2.0 / 11.3.2.4 / 11.4 Catalog Number: 8891640",".",,"Carestream Health, Inc. has issued a recall when using the CARESTREAM Client Workstation where under very specific conditions, some images from multi-slice studies such as CT and MR may not load into the viewer application due to a software problem. ",9/16/2013,"09/16/2013",11/20/2013,"11/20/2013"
"Devices",66306,"Ongoing","Carestream Health Inc.","Rochester","NY","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution - USA including AR, AZ, CA, CO, CT, FL, IA, IL, MA, MD, ME, MN, MO, NC, NH, NV, NY, OH, OK, PA, RI, TN, UT, VA WA, and WI and Internationally to Canada, Japan, and Kuwait.","Z-0230-2014","Class II","Carestream Vue PACS; UNLIMITED READING LIC ADD 100K E/YR The CARESTREAM PACS is an image management system whose intended use is to provide completely scaleable local and wide area PACS solutions for hospital and related institutions/sites, which will archive, distribute, retrieve and display images and data from all hospital modalities and information systems.","Model: Vue PACS client version 11.3.2.0 / 11.3.2.4 / 11.4 Catalog Number: 8768178",".",,"Carestream Health, Inc. has issued a recall when using the CARESTREAM Client Workstation where under very specific conditions, some images from multi-slice studies such as CT and MR may not load into the viewer application due to a software problem. ",9/16/2013,"09/16/2013",11/20/2013,"11/20/2013"
"Devices",66306,"Ongoing","Carestream Health Inc.","Rochester","NY","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution - USA including AR, AZ, CA, CO, CT, FL, IA, IL, MA, MD, ME, MN, MO, NC, NH, NV, NY, OH, OK, PA, RI, TN, UT, VA WA, and WI and Internationally to Canada, Japan, and Kuwait.","Z-0227-2014","Class II","Carestream Vue PACS; UNLIMITED READING LIC < 50K EX/YR The CARESTREAM PACS is an image management system whose intended use is to provide completely scaleable local and wide area PACS solutions for hospital and related institutions/sites, which will archive, distribute, retrieve and display images and data from all hospital modalities and information systems.","Model: Vue PACS client version 11.3.2.0 / 11.3.2.4 / 11.4 Catalog Number: 1560713",".",,"Carestream Health, Inc. has issued a recall when using the CARESTREAM Client Workstation where under very specific conditions, some images from multi-slice studies such as CT and MR may not load into the viewer application due to a software problem. ",9/16/2013,"09/16/2013",11/20/2013,"11/20/2013"
"Devices",66306,"Ongoing","Carestream Health Inc.","Rochester","NY","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution - USA including AR, AZ, CA, CO, CT, FL, IA, IL, MA, MD, ME, MN, MO, NC, NH, NV, NY, OH, OK, PA, RI, TN, UT, VA WA, and WI and Internationally to Canada, Japan, and Kuwait.","Z-0219-2014","Class II","Carestream Vue PACS; Virtual Enterprise SW StandAlone The CARESTREAM PACS is an image management system whose intended use is to provide completely scaleable local and wide area PACS solutions for hospital and related institutions/sites, which will archive, distribute, retrieve and display images and data from all hospital modalities and information systems.","Model: Vue PACS client version 11.3.2.0 / 11.3.2.4 / 11.4 Catalog Number: 8171837",".",,"Carestream Health, Inc. has issued a recall when using the CARESTREAM Client Workstation where under very specific conditions, some images from multi-slice studies such as CT and MR may not load into the viewer application due to a software problem. ",9/16/2013,"09/16/2013",11/20/2013,"11/20/2013"
"Devices",66306,"Ongoing","Carestream Health Inc.","Rochester","NY","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution - USA including AR, AZ, CA, CO, CT, FL, IA, IL, MA, MD, ME, MN, MO, NC, NH, NV, NY, OH, OK, PA, RI, TN, UT, VA WA, and WI and Internationally to Canada, Japan, and Kuwait.","Z-0217-2014","Class II","Carestream Vue PACS; Virtual Access Software, StandAlone The CARESTREAM PACS is an image management system whose intended use is to provide completely scaleable local and wide area PACS solutions for hospital and related institutions/sites, which will archive, distribute, retrieve and display images and data from all hospital modalities and information systems.","Model: Vue PACS client version 11.3.2.0 / 11.3.2.4 / 11.4 Catalog Number: 1301761",".",,"Carestream Health, Inc. has issued a recall when using the CARESTREAM Client Workstation where under very specific conditions, some images from multi-slice studies such as CT and MR may not load into the viewer application due to a software problem. ",9/16/2013,"09/16/2013",11/20/2013,"11/20/2013"
"Devices",66306,"Ongoing","Carestream Health Inc.","Rochester","NY","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution - USA including AR, AZ, CA, CO, CT, FL, IA, IL, MA, MD, ME, MN, MO, NC, NH, NV, NY, OH, OK, PA, RI, TN, UT, VA WA, and WI and Internationally to Canada, Japan, and Kuwait.","Z-0211-2014","Class II","Carestream Vue PACS; VIRTUAL ACCESS SOFTWARE, WORKGROUP The CARESTREAM PACS is an image management system whose intended use is to provide completely scaleable local and wide area PACS solutions for hospital and related institutions/sites, which will archive, distribute, retrieve and display images and data from all hospital modalities and information systems.","Model: Vue PACS client version 11.3.2.0 / 11.3.2.4 / 11.4 Catalog Number: 1975903",".",,"Carestream Health, Inc. has issued a recall when using the CARESTREAM Client Workstation where under very specific conditions, some images from multi-slice studies such as CT and MR may not load into the viewer application due to a software problem. ",9/16/2013,"09/16/2013",11/20/2013,"11/20/2013"
"Devices",66306,"Ongoing","Carestream Health Inc.","Rochester","NY","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution - USA including AR, AZ, CA, CO, CT, FL, IA, IL, MA, MD, ME, MN, MO, NC, NH, NV, NY, OH, OK, PA, RI, TN, UT, VA WA, and WI and Internationally to Canada, Japan, and Kuwait.","Z-0245-2014","Class II","Carestream Vue PACS; UPG MX-O SVR 25K EX/YR UNLIMITED The CARESTREAM PACS is an image management system whose intended use is to provide completely scaleable local and wide area PACS solutions for hospital and related institutions/sites, which will archive, distribute, retrieve and display images and data from all hospital modalities and information systems.","Model: Vue PACS client version 11.3.2.0 / 11.3.2.4 / 11.4 Catalog Number: 8859811",".",,"Carestream Health, Inc. has issued a recall when using the CARESTREAM Client Workstation where under very specific conditions, some images from multi-slice studies such as CT and MR may not load into the viewer application due to a software problem. ",9/16/2013,"09/16/2013",11/20/2013,"11/20/2013"
"Devices",66306,"Ongoing","Carestream Health Inc.","Rochester","NY","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution - USA including AR, AZ, CA, CO, CT, FL, IA, IL, MA, MD, ME, MN, MO, NC, NH, NV, NY, OH, OK, PA, RI, TN, UT, VA WA, and WI and Internationally to Canada, Japan, and Kuwait.","Z-0249-2014","Class II","Carestream Vue PACS; MX WEB SVR W/3 MX-RAD LIC<50K EX/YR The CARESTREAM PACS is an image management system whose intended use is to provide completely scaleable local and wide area PACS solutions for hospital and related institutions/sites, which will archive, distribute, retrieve and display images and data from all hospital modalities and information systems.","Model: Vue PACS client version 11.3.2.0 / 11.3.2.4 / 11.4 Catalog Number: 8062374",".",,"Carestream Health, Inc. has issued a recall when using the CARESTREAM Client Workstation where under very specific conditions, some images from multi-slice studies such as CT and MR may not load into the viewer application due to a software problem. ",9/16/2013,"09/16/2013",11/20/2013,"11/20/2013"
"Devices",66306,"Ongoing","Carestream Health Inc.","Rochester","NY","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution - USA including AR, AZ, CA, CO, CT, FL, IA, IL, MA, MD, ME, MN, MO, NC, NH, NV, NY, OH, OK, PA, RI, TN, UT, VA WA, and WI and Internationally to Canada, Japan, and Kuwait.","Z-0239-2014","Class II","Carestream Vue PACS; MX WEB SVR W/3 MX-O LIC < 75K EXAMS The CARESTREAM PACS is an image management system whose intended use is to provide completely scaleable local and wide area PACS solutions for hospital and related institutions/sites, which will archive, distribute, retrieve and display images and data from all hospital modalities and information systems.","Model: Vue PACS client version 11.3.2.0 / 11.3.2.4 / 11.4 Catalog Number: 848164",".",,"Carestream Health, Inc. has issued a recall when using the CARESTREAM Client Workstation where under very specific conditions, some images from multi-slice studies such as CT and MR may not load into the viewer application due to a software problem. ",9/16/2013,"09/16/2013",11/20/2013,"11/20/2013"
"Devices",66306,"Ongoing","Carestream Health Inc.","Rochester","NY","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution - USA including AR, AZ, CA, CO, CT, FL, IA, IL, MA, MD, ME, MN, MO, NC, NH, NV, NY, OH, OK, PA, RI, TN, UT, VA WA, and WI and Internationally to Canada, Japan, and Kuwait.","Z-0238-2014","Class II","Carestream Vue PACS; MX WEB SVR W/3 MX-O LIC < 50K EXAMS The CARESTREAM PACS is an image management system whose intended use is to provide completely scaleable local and wide area PACS solutions for hospital and related institutions/sites, which will archive, distribute, retrieve and display images and data from all hospital modalities and information systems.","Model: Vue PACS client version 11.3.2.0 / 11.3.2.4 / 11.4 Catalog Number: 1549377",".",,"Carestream Health, Inc. has issued a recall when using the CARESTREAM Client Workstation where under very specific conditions, some images from multi-slice studies such as CT and MR may not load into the viewer application due to a software problem. ",9/16/2013,"09/16/2013",11/20/2013,"11/20/2013"
"Devices",66306,"Ongoing","Carestream Health Inc.","Rochester","NY","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution - USA including AR, AZ, CA, CO, CT, FL, IA, IL, MA, MD, ME, MN, MO, NC, NH, NV, NY, OH, OK, PA, RI, TN, UT, VA WA, and WI and Internationally to Canada, Japan, and Kuwait.","Z-0215-2014","Class II","Carestream Vue PACS; Virtual PWR Reading Basic SW Workgroup The CARESTREAM PACS is an image management system whose intended use is to provide completely scaleable local and wide area PACS solutions for hospital and related institutions/sites, which will archive, distribute, retrieve and display images and data from all hospital modalities and information systems.","Model: Vue PACS client version 11.3.2.0 / 11.3.2.4 / 11.4 Catalog Number: 1467067",".",,"Carestream Health, Inc. has issued a recall when using the CARESTREAM Client Workstation where under very specific conditions, some images from multi-slice studies such as CT and MR may not load into the viewer application due to a software problem. ",9/16/2013,"09/16/2013",11/20/2013,"11/20/2013"
"Devices",66306,"Ongoing","Carestream Health Inc.","Rochester","NY","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution - USA including AR, AZ, CA, CO, CT, FL, IA, IL, MA, MD, ME, MN, MO, NC, NH, NV, NY, OH, OK, PA, RI, TN, UT, VA WA, and WI and Internationally to Canada, Japan, and Kuwait.","Z-0235-2014","Class II","Carestream Vue PACS; MX WEB SVR W/3 MX-O LIC< 7.5K EXAMS The CARESTREAM PACS is an image management system whose intended use is to provide completely scaleable local and wide area PACS solutions for hospital and related institutions/sites, which will archive, distribute, retrieve and display images and data from all hospital modalities and information systems.","Model: Vue PACS client version 11.3.2.0 / 11.3.2.4 / 11.4 Catalog Number: 8101768",".",,"Carestream Health, Inc. has issued a recall when using the CARESTREAM Client Workstation where under very specific conditions, some images from multi-slice studies such as CT and MR may not load into the viewer application due to a software problem. ",9/16/2013,"09/16/2013",11/20/2013,"11/20/2013"
"Devices",66306,"Ongoing","Carestream Health Inc.","Rochester","NY","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution - USA including AR, AZ, CA, CO, CT, FL, IA, IL, MA, MD, ME, MN, MO, NC, NH, NV, NY, OH, OK, PA, RI, TN, UT, VA WA, and WI and Internationally to Canada, Japan, and Kuwait.","Z-0241-2014","Class II","Carestream Vue PACS; UPG MX-O SVR 15K EX/YR UNLIMITED The CARESTREAM PACS is an image management system whose intended use is to provide completely scaleable local and wide area PACS solutions for hospital and related institutions/sites, which will archive, distribute, retrieve and display images and data from all hospital modalities and information systems.","Model: Vue PACS client version 11.3.2.0 / 11.3.2.4 / 11.4 Catalog Number: 8485021",".",,"Carestream Health, Inc. has issued a recall when using the CARESTREAM Client Workstation where under very specific conditions, some images from multi-slice studies such as CT and MR may not load into the viewer application due to a software problem. ",9/16/2013,"09/16/2013",11/20/2013,"11/20/2013"
"Devices",66306,"Ongoing","Carestream Health Inc.","Rochester","NY","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution - USA including AR, AZ, CA, CO, CT, FL, IA, IL, MA, MD, ME, MN, MO, NC, NH, NV, NY, OH, OK, PA, RI, TN, UT, VA WA, and WI and Internationally to Canada, Japan, and Kuwait.","Z-0252-2014","Class II","Carestream Vue PACS; MX WEB SW/5 MX-RAD CONCUR USER LIC The CARESTREAM PACS is an image management system whose intended use is to provide completely scaleable local and wide area PACS solutions for hospital and related institutions/sites, which will archive, distribute, retrieve and display images and data from all hospital modalities and information systems.","Model: Vue PACS client version 11.3.2.0 / 11.3.2.4 / 11.4 Catalog Number: 8203101",".",,"Carestream Health, Inc. has issued a recall when using the CARESTREAM Client Workstation where under very specific conditions, some images from multi-slice studies such as CT and MR may not load into the viewer application due to a software problem. ",9/16/2013,"09/16/2013",11/20/2013,"11/20/2013"
"Devices",66306,"Ongoing","Carestream Health Inc.","Rochester","NY","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution - USA including AR, AZ, CA, CO, CT, FL, IA, IL, MA, MD, ME, MN, MO, NC, NH, NV, NY, OH, OK, PA, RI, TN, UT, VA WA, and WI and Internationally to Canada, Japan, and Kuwait.","Z-0218-2014","Class II","Carestream Vue PACS; Virtual Access Pluse SW, StandAlone The CARESTREAM PACS is an image management system whose intended use is to provide completely scaleable local and wide area PACS solutions for hospital and related institutions/sites, which will archive, distribute, retrieve and display images and data from all hospital modalities and information systems.","Model: Vue PACS client version 11.3.2.0 / 11.3.2.4 / 11.4 Catalog Number: 1337195",".",,"Carestream Health, Inc. has issued a recall when using the CARESTREAM Client Workstation where under very specific conditions, some images from multi-slice studies such as CT and MR may not load into the viewer application due to a software problem. ",9/16/2013,"09/16/2013",11/20/2013,"11/20/2013"
"Devices",66306,"Ongoing","Carestream Health Inc.","Rochester","NY","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution - USA including AR, AZ, CA, CO, CT, FL, IA, IL, MA, MD, ME, MN, MO, NC, NH, NV, NY, OH, OK, PA, RI, TN, UT, VA WA, and WI and Internationally to Canada, Japan, and Kuwait.","Z-0224-2014","Class II","Carestream Vue PACS; MX WEB SVR W/3 MX-RAD LIC<7.5K EX/Y The CARESTREAM PACS is an image management system whose intended use is to provide completely scaleable local and wide area PACS solutions for hospital and related institutions/sites, which will archive, distribute, retrieve and display images and data from all hospital modalities and information systems.","Model: Vue PACS client version 11.3.2.0 / 11.3.2.4 / 11.4 Catalog Number: 1673334",".",,"Carestream Health, Inc. has issued a recall when using the CARESTREAM Client Workstation where under very specific conditions, some images from multi-slice studies such as CT and MR may not load into the viewer application due to a software problem. ",9/16/2013,"09/16/2013",11/20/2013,"11/20/2013"
"Devices",66306,"Ongoing","Carestream Health Inc.","Rochester","NY","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution - USA including AR, AZ, CA, CO, CT, FL, IA, IL, MA, MD, ME, MN, MO, NC, NH, NV, NY, OH, OK, PA, RI, TN, UT, VA WA, and WI and Internationally to Canada, Japan, and Kuwait.","Z-0257-2014","Class II","Carestream Vue PACS; UPG MX-RAD SVR 15K EX/YR UNLIMITED The CARESTREAM PACS is an image management system whose intended use is to provide completely scaleable local and wide area PACS solutions for hospital and related institutions/sites, which will archive, distribute, retrieve and display images and data from all hospital modalities and information systems.","Model: Vue PACS client version 11.3.2.0 / 11.3.2.4 / 11.4 Catalog Number: 1981042",".",,"Carestream Health, Inc. has issued a recall when using the CARESTREAM Client Workstation where under very specific conditions, some images from multi-slice studies such as CT and MR may not load into the viewer application due to a software problem. ",9/16/2013,"09/16/2013",11/20/2013,"11/20/2013"
"Devices",66306,"Ongoing","Carestream Health Inc.","Rochester","NY","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution - USA including AR, AZ, CA, CO, CT, FL, IA, IL, MA, MD, ME, MN, MO, NC, NH, NV, NY, OH, OK, PA, RI, TN, UT, VA WA, and WI and Internationally to Canada, Japan, and Kuwait.","Z-0229-2014","Class II","Carestream Vue PACS; UNLIMITED READING LIC ADD 25K EX/YR The CARESTREAM PACS is an image management system whose intended use is to provide completely scaleable local and wide area PACS solutions for hospital and related institutions/sites, which will archive, distribute, retrieve and display images and data from all hospital modalities and information systems.","Model: Vue PACS client version 11.3.2.0 / 11.3.2.4 / 11.4 Catalog Number: 1645324",".",,"Carestream Health, Inc. has issued a recall when using the CARESTREAM Client Workstation where under very specific conditions, some images from multi-slice studies such as CT and MR may not load into the viewer application due to a software problem. ",9/16/2013,"09/16/2013",11/20/2013,"11/20/2013"
"Devices",66306,"Ongoing","Carestream Health Inc.","Rochester","NY","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution - USA including AR, AZ, CA, CO, CT, FL, IA, IL, MA, MD, ME, MN, MO, NC, NH, NV, NY, OH, OK, PA, RI, TN, UT, VA WA, and WI and Internationally to Canada, Japan, and Kuwait.","Z-0236-2014","Class II","Carestream Vue PACS; MX WEB SVR W/3 MX-O LIC < 15K EXAMS The CARESTREAM PACS is an image management system whose intended use is to provide completely scaleable local and wide area PACS solutions for hospital and related institutions/sites, which will archive, distribute, retrieve and display images and data from all hospital modalities and information systems.","Model: Vue PACS client version 11.3.2.0 / 11.3.2.4 / 11.4 Catalog Number: 1630185",".",,"Carestream Health, Inc. has issued a recall when using the CARESTREAM Client Workstation where under very specific conditions, some images from multi-slice studies such as CT and MR may not load into the viewer application due to a software problem. ",9/16/2013,"09/16/2013",11/20/2013,"11/20/2013"
"Devices",66306,"Ongoing","Carestream Health Inc.","Rochester","NY","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution - USA including AR, AZ, CA, CO, CT, FL, IA, IL, MA, MD, ME, MN, MO, NC, NH, NV, NY, OH, OK, PA, RI, TN, UT, VA WA, and WI and Internationally to Canada, Japan, and Kuwait.","Z-0255-2014","Class II","Carestream Vue PACS; MX WEB SW/25 MX-RAD CONCUR USER LIC The CARESTREAM PACS is an image management system whose intended use is to provide completely scaleable local and wide area PACS solutions for hospital and related institutions/sites, which will archive, distribute, retrieve and display images and data from all hospital modalities and information systems.","Model: Vue PACS client version 11.3.2.0 / 11.3.2.4 / 11.4 Catalog Number: 1618198",".",,"Carestream Health, Inc. has issued a recall when using the CARESTREAM Client Workstation where under very specific conditions, some images from multi-slice studies such as CT and MR may not load into the viewer application due to a software problem. ",9/16/2013,"09/16/2013",11/20/2013,"11/20/2013"
"Devices",66306,"Ongoing","Carestream Health Inc.","Rochester","NY","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution - USA including AR, AZ, CA, CO, CT, FL, IA, IL, MA, MD, ME, MN, MO, NC, NH, NV, NY, OH, OK, PA, RI, TN, UT, VA WA, and WI and Internationally to Canada, Japan, and Kuwait.","Z-0256-2014","Class II","Carestream Vue PACS; UPG MX-RAD SVR 7.5K EX/YR UNLIMITED The CARESTREAM PACS is an image management system whose intended use is to provide completely scaleable local and wide area PACS solutions for hospital and related institutions/sites, which will archive, distribute, retrieve and display images and data from all hospital modalities and information systems.","Model: Vue PACS client version 11.3.2.0 / 11.3.2.4 / 11.4 Catalog Number: 1738905",".",,"Carestream Health, Inc. has issued a recall when using the CARESTREAM Client Workstation where under very specific conditions, some images from multi-slice studies such as CT and MR may not load into the viewer application due to a software problem. ",9/16/2013,"09/16/2013",11/20/2013,"11/20/2013"
"Biologics",66308,"Terminated","Talecris Plasma Resources Inc","Louisville","KY","US","Voluntary: Firm Initiated","FAX","North Carolina","B-0097-14","Class II","Source Plasma","3510256577",".","1 unit","Blood product, collected from a donor who received a tattoo within one year of donation, was distributed.",8/5/2013,"08/05/2013",12/4/2013,"12/04/2013"
"Biologics",66309,"Terminated","Central Blood Bank","Pittsburgh","PA","US","Voluntary: Firm Initiated","Telephone","Pennsylvania","B-0071-14","Class II","Platelets Pheresis Leukocytes Reduced","W085013001366",".","1 unit","Blood product, which was labeled as leukoreduced, but was not tested to verify white blood cell count, was distributed.",9/3/2013,"09/03/2013",12/11/2013,"12/11/2013"
"Devices",66310,"Ongoing","Perkin Elmer Health Sciences, Inc.","Greenville","SC","US","Voluntary: Firm Initiated","E-Mail","US distribution in OH","Z-0030-2014","Class II","Perkin Elmer 226 Sample Collection Device, Serial numbers: 06132903 - 06198900. The PerkinElmer 226 Sample Collection Devices are intended to be used as a medium to collect and transport whole blood specimen spots to a laboratory, in newborn screening. The device includes a tear-apart form for the collection of demographic information.","Job number: 313119, Item Lot number: Ohio HEA 2518, Serial numbers: 06132903 - 06198900.",".","65,984 devices","Some devices may be contaminated on the back side of the device with glue in the blood application area.",9/5/2013,"09/05/2013",10/30/2013,"10/30/2013"
"Devices",66312,"Ongoing","Philips Medical Systems (Cleveland) Inc","Cleveland","OH","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution - US (nationwide) including FL, CO, KY, MS, PA, NC, NJ, TX and Puerto Rico and internationally to Italy.","Z-0033-2014","Class II","Philips MR Systems: Asset 0.5T, Apollo 0.5T, Infinion 1.5T, Eclipse/Polaris 1.5T, Panorama 0.6T 1.0T, Magnetic Resonance Imaging Systems intended for clinical/radiologic diagnostic imaging applications. ","M/N: 781220, 781230, 781301, 78129 and 78127. Codes: AM128, 1510, 1518, BA318, AM120, ZA178, ZA196, ZA107, ZA133, ZA172, ZA158, BA149 and ZA208. ",".","Total 511 (Asset 0.5T,: 35 units Apollo 0.5T: 15 units, Infinion 1.5T: 116 units, Eclipse/Polaris 1.5T: 290 units, Panorama 0.6T: 55 units) ","There is a potential for water to collect in the vent pipe elbow in the magnet venting system. Water may freeze, blocking the venting system. ",8/7/2013,"08/07/2013",10/30/2013,"10/30/2013"
"Devices",66314,"Ongoing","Siemens Medical Solutions USA, Inc","Malvern","PA","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution - USA (nationwide) and Internationally to Canada.","Z-0140-2014","Class II","Siemens RAD Fluoro Uro system (Luminos dRF and Uroskop Omnia with software version VD10A/G Image intensified Fluoroscopic X-ray system","Model numbers 10094910 and 10094200 with software version VD10A/G.",".","59","When using systems operating with software versions VD10A/G during a RAD examination, a malfunction can result in radiation continuing longer than required resulting in an overexposed image that is not of diagnostic quality, prompting repetition of the examination.",9/3/2013,"09/03/2013",12/4/2013,"12/04/2013"
"Drugs",66316,"Ongoing","AmeriSource Bergen","Chesterbrook","PA","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Nationwide","D-1066-2013","Class II","Ifosfamide Injection 3g/60 mL, Single dose vial, Rx only, Sterile, For Intravenous Use, Refrigerate at 2-8 degrees celcius, Distributed by Pfizer Labs, Division of Pfizer Inc., New York, NY 10017, NDC 0069-4496-22","Lot #s: 7800929, 7800931, Exp 02/15; 7800962, Exp 03/15 ",,"60 vials","Temperature abuse: Certain vials of Ifosfamide IV products were not refrigerated at certain Amerisource Bergen Drug Corp distribution centers.",9/13/2013,"09/13/2013",10/9/2013,"10/09/2013"
"Drugs",66316,"Ongoing","AmeriSource Bergen","Chesterbrook","PA","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Nationwide","D-1065-2013","Class II","Ifosfamide Injection 1g/20mL, Single dose vial, Rx only, Sterile, For Intravenous Use, Refrigerate at 2-8 degrees celcius, Distributed by Pfizer Labs, Division of Pfizer Inc., New York, NY 10017, NDC 0069-4495-22 ","Lot #s: 7800932, 7800933, exp 02/15 ",,"49 vials","Temperature abuse: Certain vials of Ifosfamide IV products were not refrigerated at certain Amerisource Bergen Drug Corp distribution centers.",9/13/2013,"09/13/2013",10/9/2013,"10/09/2013"
"Devices",66317,"Ongoing","Advanced Sterilization Products","Irvine","CA","US","Voluntary: Firm Initiated","Letter","Nationwide Distribution","Z-0044-2014","Class II","STERRAD 100NX Cassettes The STERRAD Sterilization System is a low temperature general purpose sterilizer used to sterilize heat and moisture sensitive reusable medical devices.","Lot# 13F050, 13F051, 13F049",".","2,995 units","Advanced Sterilization Products (ASP) is recalling the three lots (13F049, 13F050, 13F051) STERRAD 100NX Cassettes because ASP has determined that the leak indicator on the cassettes is effective for only 12 months of the cassette's labeled 15-month shelf-life.",9/18/2013,"09/18/2013",10/30/2013,"10/30/2013"
"Drugs",66318,"Ongoing","Amgen, Inc.","Thousand Oaks","CA","US","Voluntary: Firm Initiated","Letter","Nationwide and Puerto Rico, Canada, Mexico, and clinical distribution in Europe.","D-66318-001","Class II","Prolia (denosumab) Injection, 60 mg/mL, 1 x 60 mg Single Use Prefilled Syringe per carton, Rx only, Manufactured by: Amgen Manufacturing Ltd., a subsidiary of Amgen Inc., Thousand Oaks, CA 91320-1799,NDC 55513-710-01, UPC 3 55513 71001 5.","Lot #: 1037592, Exp 07/15",".","4,163 prefilled syringes","Presence of Particulate Matter: Visible cellulose fibers were observed in a small number of prefilled syringes during a routine quality examination.",9/17/2013,"09/17/2013",11/13/2013,"11/13/2013"
"Food",66319,"Ongoing","Irene's Bakery & Gourmet Kitchen, Inc.","Bensalem","PA","US","Voluntary: Firm Initiated","Telephone","Local and nationwide wholesale distributors and retail markets.","F-1946-2013","Class I","Irene's Black & White Cookies, 8 oz. (226.4g) All Natural. Ingredients: Sugar, wheat flour, water, eggs, canola oil, unmodified food starch, corn syrup, vegetable fat, cocoa powder processed with alkali, mono and diglycerides, sea salt, sodium acid pyrophosphate, sodium bicarbonate, mono calcium phosphate, soy lecithin, natural flavors. May contain traces of tree nuts. Manufactured by Irene's Bakery and Gourmet Kitchen, Bensalem, PA. ","actual date code information are not available. Two-week expiration dates are assigned by the retail store upon receipt of shipment from the manufacturer. ",".","2008 packages (87 cases of 24 or 16 eight oz. packages/case) ","Undeclared whey powder (milk allergen) sub-ingredient of chocolate confectionery coating used in manufacturing of Black & White Cookies. ",8/26/2013,"08/26/2013",10/2/2013,"10/02/2013"
"Food",66320,"Ongoing","Conagra Inc","Omaha","NE","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","The product was distributed to AL, AR, AZ, CA, CO, CN, DE, FL, GA, IA, IL, IN, KS, KY, LA, MD, ME, MI, MO, MI, NC, NE, NM, NV, NY, OH, OK, PE, SC, TN, TX, UT, VI, WA, WI and WY. No foreign distribution was made, including Canada. There may be one military client. The firm is gathering the distribution information and will forward that to KAN-DO as soon as it is ready.","F-0085-2014","Class I","P.F. Chang's Home Menu, Pork & Leek Dumplings, frozen, packaged in 12.5 oz bags. UPC: 0 36200 21215 8 ","Lot code: 0663 312871 and 0663 312972, Use By MAY082014 and Lot code: 0663 312971 and 0663 312972, Use By MAY092014. ",,"13,066/4/12.5 oz-bags/case","The firm is recalling Pork & Leek Dumplings because Shrimp & Pollack Fish dumplings were inadvertently packaged in the Pork & Leek Dumpling packaging. Undeclared allergens.",9/18/2013,"09/18/2013",11/6/2013,"11/06/2013"
"Food",66321,"Ongoing","Dean Foods, Inc.","Dallas","TX","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Products sold to various accounts in Southern California and Arizona only.","F-0009-2014","Class III","Fruit Rush Black Cherry Artificially Flavored Fruit Drink, One Gallon, Plant 06-704","All production dates from May 21 to September 16, 2013, UPC: 0-41900-07369-5. Recall includes ''Best By'' dates through January 10, 2014.",".","Unknown","The product has the potential to spoil prematurely.",9/17/2013,"09/17/2013",10/30/2013,"10/30/2013"
"Food",66321,"Ongoing","Dean Foods, Inc.","Dallas","TX","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Products sold to various accounts in Southern California and Arizona only.","F-0011-2014","Class III","Fruit Rush Lemon Lime Artificially Flavored Fruit Drink, One Gallon, Plant 06-704","All production dates from May 21 to September 16, 2013, UPC: 0-41900-07368-8. Recall includes ''Best By'' dates through January 10, 2014.",".","Unknown","The product has the potential to spoil prematurely.",9/17/2013,"09/17/2013",10/30/2013,"10/30/2013"
"Food",66321,"Ongoing","Dean Foods, Inc.","Dallas","TX","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Products sold to various accounts in Southern California and Arizona only.","F-0010-2014","Class III","Fruit Rush Fruit Punch Artificially Flavored Fruit Drink, One Gallon, Plant 06-704","All production dates from May 21 to September 16, 2013, UPC: 0-41900-07362-6. Recall includes ''Best By'' dates through January 10, 2014.",".","Unknown","The product has the potential to spoil prematurely.",9/17/2013,"09/17/2013",10/30/2013,"10/30/2013"
"Devices",66322,"Terminated","Medtronic Vascular, Inc.","Santa Rosa","CA","US","Voluntary: Firm Initiated","Letter","International distribution:Austria, Belgium, Cyprus, Czech Republic, Denmark, Finland, Germany, Greece, Hungary, Iceland, Ireland, It lay, Latvia, Lithuania, Luxembourg, Netherlands, Norway, Poland, Portugal, Slovakia, Slovenia, Spain, Sweden, Switzerland, Turkey, United Kingdom.","Z-0083-2014","Class II","Valiant Thoracic Stent Graft with Captivia Delivery System, Talent Thoracic Stent Graft with the Captivia Delivery System.","TBXXXXXXXXCP, TFXXXXXXXXCP, TWXXXXXXXXCP, TAXFXXXXXXXCP, TAXWXXXXXXXCP, VAMFXXXXXXXXTE, VAMCXXXXXXXXTE, VAMFXXXXXXXXTU, VAMCXXXXXXXXTU.",,"~1000","Firm received reports of difficulty in flushing the graft cover of the delivery system during device preparation as required by IFU.",9/19/2012,"09/19/2012",11/6/2013,"11/06/2013"
"Food",66324,"Terminated","Wegmans Food Markets","Rochester","NY","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","New York, Pennsylvania, New Jersey, Maryland, Virginia, and Massachusetts.","F-0002-2014","Class I","Wegmans Bakery Mini Muffins APPLE CINNAMON, NET WT 14 OZ (397g) , UPC 77890 18951 --- Baked By Wegmans Food Markets Inc., Rochester, NY 14603","All date codes up to and including ''Best if used by 9/24/13''",,"4,327 units ","The Apple Cinnamon Mini Muffins contain undeclared soy, a known allergen.",9/19/2013,"09/19/2013",10/23/2013,"10/23/2013"
"Devices",66325,"Terminated","Becton Dickinson & Co.","Sparks","MD","US","Voluntary: Firm Initiated","Letter","USA Nationwide Disatribution in the states of: AL, AR, AZ, CA, CO, CT, FL, GA, IL, KY, MA, ME, MN, MO, NC, ND, NJ, NV, NY, OH, PA, TX, UT, VA, WA, WI","Z-0028-2014","Class II","BBL (tm) MGIT (tm) Mycobacteria Growth Indicator Tube, part # 245122, packaged in 100 ct cartons and labeled in part Product Usage: The Mycobacteria Growth Indicator Tube supplemented with Bactec MGIT Growth Supplement and BBL MGIT PANTA antibiotic mixture is intended for the detection and recovery of mycobacteria using the BACTEC MGIT 960 and BACTEC MGIT 320 Systems. Acceptable specimen types are digested and decontaminated clinical specimens (except urine), and sterile body fluids (except blood).","Lot Number/ Exp. Date 3070436 September 12, 2014 3042466 August 16, 2014 3053239 August 30, 2014 3053240 August 30, 2014 3061013 September 6, 2014 3061014 September 6, 2014 3070433 September 12, 2014 3070437 September 12 , 2014",".","187,000 tubes","An in-vitro diagnostic reagent may be labeled with an incorrect barcode, which when scanned on associated diagnostic instrument may cause a false negative result.",9/9/2013,"09/09/2013",10/30/2013,"10/30/2013"
"Food",66326,"Ongoing","The Dannon Company, Inc","West Jordan","UT","US","Voluntary: Firm Initiated","Letter","Arizona, California, Colorado, Nevada, Utah, Washington, and Wyoming. 324 cases were distributed to govt/military/VA consignees. No foreign consignees.","F-1954-2013","Class II","Dannon ACTIVIA LIGHT Nonfat Yogurt Strawberry-Banana & Peach Flavor, 12 PACK of 4oz cups, Form fill seal 4oz cup","UPC 36632 02764 With the following expiration codes: Expiration code of PLT 49-64 SEP 24 2013 WJ, Expiration code of PLT 49-64 SEP 29 2013 WJ, Expiration code of PLT 49-64 OCT 08 2013 WJ",".","6045 cases","Dannon Company is recalling certain lots of ACTIVIA LIGHT Nonfat Yogurt Strawberry/Banana & Peach Flavors due to the potential for mold.",9/18/2013,"09/18/2013",10/2/2013,"10/02/2013"
"Devices",66328,"Ongoing","Advanced Sterilization Products","Irvine","CA","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution - USA (nationwide) and the countries of EA (Europe Middle East and Asia), APAC (Asia Pacific), Japan and Canada","Z-0043-2014","Class II","STERRAD 200 Sterilizer (Single Door), Part Number: 10201. STERRAD 200 Sterilizer (Double Door), Part Number: 10202. The STERRAD Sterilization System is a low temperature general purpose sterilizer used to sterilize heat and moisture sensitive reusable medical devices.","Lot A: 0009*ENG 0003*FG 0048*FG 0050*MRB 0237*YAMATO 0239*YAMATO 0097*FSRIP 0097*FG 315*TTL 316*TTL 317*TTL 318*TTL 314*FG 325*TTL 326*TTL 334*FG 335*FG 329*TTL 345*TTL 357*FG 359*FG 358*FG 344*TTL 351*FG 347*TTL 352*TTL 348*TTL 348*FG 360*TTL 361*TTL 364*FG 362*TTL 383*YAMATO 365*TTL 368*TTL 371*FG 369*TTL 370*TTL 374*TTL 378*TTL 379*TTL 397*TTL 376*TTL 398*TTL 400*TTL 401*TTL 402*TTL 386*TTL 403*TTL 404*TTL 406*TTL 405*TTL 399*TTL 419*TTL 388*TTL 420*TTL 421*TTL 0239*CD33 422*TTL 423*TTL 429*YAMATO 424*TTL 439*YAMATO 425*TTL 427*TTL 346*TTL 423*TTL 372*TTL 430*TTL 428*TTL 395*TTL 431*TTL 433*TTL 447*YAMATO 432*TTL 434*TTL 435*TTL 437*TTL 436*TTL 453*YAMATO 454*YAMATO 452*YAMATO 440*TTL 412*TTL 455*YAMATO 456*YAMATO 468*FG 460*FG 458*FG 459*FG 462*FG 463*FG 464*FG 473*FG 470*FG 465*FG 488*YAMATO 476*FG 481*FG 487*YAMATO 502*FG 482*FG 501*FG 484*FG 485*FG 486*FG 483*FG 479*TTL 493*FG 492*FG 495*YAMATO 494*FG 509*YAMATO 504*TTL 503*TTL 505*TTL 506*TTL 507*TTL 512*TTL 524*TTL 540*YAMATO 538*YAMATO 539*YAMATO 537*YAMATO 541*YAMATO 508*TTL 520*TTL 519*TTL 518*TTL 516*TTL 521*TTL 522*TTL 523*TTL 556*TTL 525*TTL 526*TTL 524*TTL 528*TTL 529*TTL 530*TTL 532*TTL 531*TTL 515*FG 533*TTL 534*TTL 535*TTL 557*TTL 536*TTL 568*YAMATO 570*YAMATO 575*YAMATO 543*TTL 545*TTL 544*TTL 571*YAMATO 546*TTL 548*TTL 547*TTL 549*TTL 550*TTL 554*TTL 553*TTL 552*TTL 558*TTL 555*TTL 581*YAMATO 559*TTL 560*TTL 561*TTL 585*YAMATO 562*TTL 563*TTL 576*TTL 579*TTL 593*TTL 595*TTL 591*YAMATO 590*YAMATO 596*FG 597*TTL 606*YAMATO 602*TTL 601*TTL 599*TTL 598*TTL 607*YAMATO 604*TTL 603*TTL 612*FG 616*YAMATO 611*TTL 628*TTL 615*TTL 629*TTL 632*TTL 630*TTL 631*TTL 605*TTL 625*YAMATO 621*YAMATO 643*TTL 633*TTL 644*TTL 645*TTL 656*TTL 652*TTL 655*TTL 658*TTL 646*TTL 654*FG 659*FG 660*TTL 662*TTL 680*TTL 663*TTL 665*TTL 666*TTL 664*TTL 667*TTL 683*TTL 685*TTL 686*TTL 684*TTL 650*YAMATO 620*YAMATO 653*TTL 679*TTL 682*TTL 690*TTL 692*TTL 691*TTL 693*TTL 694*TTL 695*TTL 696*TTL 689*TTL 688*TTL 687*TTL 661*TTL 703*TTL 699*TTL 697*YAMATO 706*TTL 705*TTL 704*TT",".","1,305 units total (654 units in US , 651 OUS )","Advanced Sterilization Products (ASP) is recalling the STERRAD 200 Sterilization System because it may emit an odor or smell into the surrounding environment that is not typical to normal operating conditions.",9/18/2013,"09/18/2013",10/30/2013,"10/30/2013"
"Food",66329,"Ongoing","Kerry Foods","Beloit","WI","US","Voluntary: Firm Initiated","Telephone","ID","F-0181-2014","Class II","Idahoan, Steakhouse Parmesan topping, Net Weight 35 lbs., Item Code ZID800Bulk.","Lot 3239",,"10,500 lbs. (300 x 35 pound units)","Steakhouse Parmmesan Topping was produced on the same equipment line as another product that tested positive for Salmonella.",9/13/2013,"09/13/2013",11/27/2013,"11/27/2013"
"Drugs",66330,"Ongoing","Walgreens Co","Deerfield","IL","US","Voluntary: Firm Initiated","Telephone","Nationwide","D-1063-2013","Class II","Walgreens Progesterone in Ethyl Oleate 50 mg per mL Injection, 10 mL vial, Inject 1 mL Intramuscularly as directed by physician, Walgreens Specialty Pharmacy, Fresco, TX.","Lot #: P50EO07121390A, Exp 1/12/14",".","298 vials","Lack of Assurance of Sterility: Walgreens Specialty Pharmacy is recalling one lot of Progesterone in Ethyl Oleate sterile injection due to concerns of sterility assurance with the specialty pharmacy's independent testing laboratory.",8/23/2013,"08/23/2013",10/2/2013,"10/02/2013"
"Devices",66331,"Ongoing","SEPPIM SAS","SEES",,"FR","Voluntary: Firm Initiated","Letter","Worldwide Distribution - US including the states of KY and UT and the country of Sweden.","Z-0178-2014","Class II","Calcium Arsenazo, CALA-0250, For the Quantitative Determination of Total Calcium in Human Serum. The kit label shows CALCIUM ARSENAZO, CALA-0250, R: 12x20 mL. The vial's label shows CALCIUM ARSENAZO, CALA-5220, 20 mL, . CALCIUM ARSENAZO is intended use for the quantitative in vitro diagnostic determination of total calcium in human serum and plasma on ELITech Clinical Systems Selectra Pro Series Analyzers. Calcium measurements are used in the diagnosis and treatment of parathyroid disease, a variety of bone diseases, chronic renal disease and tetany (intermittent muscular contractions or spasms). It is not intended for use in Point of Care setting.","Lot numbers distributed in the US: Lot 11-2614, Expiration 07/2013. Lot 12-1002; Expiration 03/2014. Lot 12-2220, Expiration 08/2014. Lot numbers distributed in Sweden: 11-2129, 12-2616, 11-2769, 12-2975, 10-3036, 10-0454, 10-1874, 11-0176, 11-1248, 11-1690, 12-0140, 12-0938, 12-1383, 13-0004, and 13-0408",".","47 kits in US and 48 kits in Sweden","Calcium Arsenazo Reagent, reference CALA-0250, is recalled due to complaint of plasma specimens report high results than serum.",9/4/2013,"09/04/2013",11/13/2013,"11/13/2013"
"Food",66332,"Ongoing","Semifreddi's Inc.","Alameda","CA","US","Voluntary: Firm Initiated","Visit","Products were delivered to retail stores/cafes/restaurants throughout California and to AZ, CO, NE, NJ, NY, OR and WA","F-1948-2013","Class II","Chocolate Dipped Almond Biscotti, in various sizes, wrapped in plastic, with ''Enjoy By'' dates prior to 091614, manufactured by Semifreddi's Inc, Alameda, CA. Product Size and UPC codes: 0.65 oz., case of 100 units 758843915943 0.89 oz., tub of 22 units 758843916001 1.3 oz., box of 4 units 758843915745 1.3 oz., box of 12 units 758843915967 1.3 oz., case of 50 units 758843915905 "," with Enjoy By date prior to 091614",".","Unknown","Semifreddi's Almond Biscotti and Semifreddi's Chocolate Dipped Almond Biscotti are being recalled due to undeclared allergens, milk and soy; butter did not list milk as a subingredient; lecithin did not list soy as a subingredient. ",9/7/2013,"09/07/2013",10/2/2013,"10/02/2013"
"Food",66332,"Ongoing","Semifreddi's Inc.","Alameda","CA","US","Voluntary: Firm Initiated","Visit","Products were delivered to retail stores/cafes/restaurants throughout California and to AZ, CO, NE, NJ, NY, OR and WA","F-1947-2013","Class II","Almond Biscotti, 1 oz. and 0.5 oz. wrapped in plastic, with ''Enjoy By dates prior to 091614, manufactured by Semifreddi's Inc, Alameda, CA. Product size and UPC codes 0.5 oz., case of 100 units 758843915936, 1.0 oz., box of 4 units 758843915738 , 1.0 oz., box of 12 units 758843915950, 1.0 oz., case of 50 units 758843915752, ","With ''Enjoy By'' dates prior to 091614",".","Unknown","Semifreddi's Almond Biscotti and Semifreddi's Chocolate Dipped Almond Biscotti are being recalled due to undeclared allergens, milk and soy; butter did not list milk as a subingredient; lecithin did not list soy as a subingredient.",9/7/2013,"09/07/2013",10/2/2013,"10/02/2013"
"Devices",66333,"Ongoing","Smith & Nephew Inc","Memphis","TN","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Worldwide Distribution - USA including Nevada and Internationally to United Arab Emirates, Italy, Spain, Belgium, Bulgaria, Poland, France, Japan, Netherlands, Australia, Turkey, Russian Federation, Germany and United Kingdom.","Z-0445-2014","Class II","GENESIS(R) II, PS HIGH FLEXION ARTICULAR INSERT, SIZE 3-4, 13 MM QTY: (1), REF 71420820, STERILE EO, Smith & Nephew, Inc. Memphis, TN 38116 USA Orthopedic","Batch No. 12GT20824",".","45 pieces","The Tyvek(TM) lid on one, or both, of the two trays that form a double barrier around the insert may not have been adequately sealed. ",8/27/2013,"08/27/2013",12/11/2013,"12/11/2013"
"Devices",66333,"Ongoing","Smith & Nephew Inc","Memphis","TN","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Worldwide Distribution - USA including Nevada and Internationally to United Arab Emirates, Italy, Spain, Belgium, Bulgaria, Poland, France, Japan, Netherlands, Australia, Turkey, Russian Federation, Germany and United Kingdom.","Z-0444-2014","Class II","GENESIS(R) II, POSTERIOR STABILIZED ARTICULAR INSERT, SIZE 1-2, 13 MM QTY: (1), REF 71420806, STERILE EO, Smith & Nephew, Inc. Memphis, TN 38116 USA Orthopedic","Batch No. 12GT20908",".","16 pieces","The Tyvek(TM) lid on one, or both, of the two trays that form a double barrier around the insert may not have been adequately sealed. ",8/27/2013,"08/27/2013",12/11/2013,"12/11/2013"
"Devices",66333,"Ongoing","Smith & Nephew Inc","Memphis","TN","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Worldwide Distribution - USA including Nevada and Internationally to United Arab Emirates, Italy, Spain, Belgium, Bulgaria, Poland, France, Japan, Netherlands, Australia, Turkey, Russian Federation, Germany and United Kingdom.","Z-0447-2014","Class II","GENESIS(R) II, PS HIGH FLEXION ARTICULAR INSERT, SIZE 5-6, 9 MM QTY: (1), REF 71421515, STERILE EO, Smith & Nephew, Inc. Memphis, TN 38116 USA Orthopedic","Batch No. 12GT20904",".","32 pieces","The Tyvek(TM) lid on one, or both, of the two trays that form a double barrier around the insert may not have been adequately sealed. ",8/27/2013,"08/27/2013",12/11/2013,"12/11/2013"
"Devices",66333,"Ongoing","Smith & Nephew Inc","Memphis","TN","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Worldwide Distribution - USA including Nevada and Internationally to United Arab Emirates, Italy, Spain, Belgium, Bulgaria, Poland, France, Japan, Netherlands, Australia, Turkey, Russian Federation, Germany and United Kingdom.","Z-0449-2014","Class II","GENESIS(R) II, MOBILE BEARING ARTICULAR INSERT RIGHT, SIZE 5, 9 MM QTY: (1), REF 71621509, STERILE EO, Smith & Nephew, Inc. Memphis, TN 38116 USA Orthopedic","Batch No. 12GT20940",".","8 pieces","The Tyvek(TM) lid on one, or both, of the two trays that form a double barrier around the insert may not have been adequately sealed. ",8/27/2013,"08/27/2013",12/11/2013,"12/11/2013"
"Devices",66333,"Ongoing","Smith & Nephew Inc","Memphis","TN","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Worldwide Distribution - USA including Nevada and Internationally to United Arab Emirates, Italy, Spain, Belgium, Bulgaria, Poland, France, Japan, Netherlands, Australia, Turkey, Russian Federation, Germany and United Kingdom.","Z-0446-2014","Class II","GENESIS(R) II, PS HIGH FLEXION ARTICULAR INSERT, SIZE 3-4, 9 MM QTY: (1), REF 71421508, STERILE EO, Smith & Nephew, Inc. Memphis, TN 38116 USA Orthopedic","Batch No. 12GT20822",".","80 pieces","The Tyvek(TM) lid on one, or both, of the two trays that form a double barrier around the insert may not have been adequately sealed. ",8/27/2013,"08/27/2013",12/11/2013,"12/11/2013"
"Devices",66333,"Ongoing","Smith & Nephew Inc","Memphis","TN","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Worldwide Distribution - USA including Nevada and Internationally to United Arab Emirates, Italy, Spain, Belgium, Bulgaria, Poland, France, Japan, Netherlands, Australia, Turkey, Russian Federation, Germany and United Kingdom.","Z-0448-2014","Class II","GENESIS(R) II, PS HIGH FLEXION ARTICULAR INSERT, SIZE 5-6, 11 MM QTY: (1), REF 71421516, STERILE EO, Smith & Nephew, Inc. Memphis, TN 38116 USA Orthopedic","Batch No. 12GT20775",".","46 pieces","The Tyvek(TM) lid on one, or both, of the two trays that form a double barrier around the insert may not have been adequately sealed. ",8/27/2013,"08/27/2013",12/11/2013,"12/11/2013"
"Devices",66334,"Ongoing","Medtronic Vascular, Inc.","Santa Rosa","CA","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution - USA and the countries of Australia, Belgium, Canada, Hong Kong, Malaysia, New Zealand, Singapore, Spain, Switzerland, Taiwan and Thailand.","Z-2302-2013","Class II","NC Sprinter; Rapid Exchange Balloon Dilatation Catheter; Sterile; 2.25 mm; Model NCSP22512X. Manufacturer: Medtronic, Inc. 710 Medtronic Parkway Minneapolis, MN 55432 The NC Sprinter Rapid Exchange Balloon Dilatation Catheter is a Percutaneous Transluminal Coronary Angioplasty (PTCA) Rapid Exchange System. The balloon at the distal end of the catheter can be inflated to a defined diameter at a specific pressure (see labelling). The proximal end of the catheter has a female luer for attachment to an inflation device. The catheter provides a lumen which enables the use of a guide wire to position the catheter. Radiopaque balloon marker(s) enable accurate placement. Shaft markers for brachial and femoral techniques are in place.","Lot number 207002011; Exp 5-13-2015.",,"122","Compliance chart included in lot 207002011 of the NC Sprinter RX 2.25 x 12 mm products lists the size of the device as 2.5mm instead of the correct 2.25mm size.",9/16/2013,"09/16/2013",10/9/2013,"10/09/2013"
"Devices",66335,"Ongoing","Xoran Technologies, Inc.","Ann Arbor","MI","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution - US nationwide","Z-0036-2014","Class II","Xoran Mini CT Scanner","Minicat",,"320","A description of the defect in the product or the manner in which the product fails to comply with an applicable Federal standard; The MiniCAT CT Scanners subject to this notification failed to meet Xoran's specifications for dose rate of 125 3 kVp. These 18 complaints received include dose rates both on the high and low end of Xoran's specifications. See ATTACHMENT 1 for details. (e) A n evaluation of the hazards reasonably related to defect or the failure to comply with the Federal standard; An evaluation of the health hazard was performed on the issue of dose rate/kVp being found outside Xoran's specifications on the MiniCAT CT Scanners. Xoran specifies that the dose rate must be within a tight range. This range is smaller than what is specified as passing by West Physics. West Physics had stated in a report ''For this test, a measured effective dose of less than 0.4 mSv is considered satisfactory, and a measured does of greater than 0.23 mSv (but less than 0.4 mSv) will be investigated for possible corrective action.'' A scanner that falls outside the Xoran specification of 0.23 mSv does not present a danger to the patient. ",7/27/2010,"07/27/2010",11/6/2013,"11/06/2013"
"Devices",66336,"Ongoing","Maquet Medical Systems USA","Wayne","NJ","US","Voluntary: Firm Initiated","Letter","Nationwide Distribution including AZ, FL, CO, TX, OH, VA, MN, WI, SC, IL, ND, UT, CA, OR, NY, IA, CT, SD, MI, HI, AL, MD, KS, MO","Z-0082-2014","Class II","MAQUET Getinge Group CARDIOHELP Base Unit REF 70104.7999 REF 70104.8012 Manufactured for: MAQUET Cardiopulmonary AG Made in Germany. Cardiopulmonary support system.","Part No. 70104.8012 Serial Nos. 90410440; 90410452; 90410455; 90410456; 90410457; 90410459; 90410469; 90410474; 90410480; 904104781; 90410482; 90410484; 90410498; 90410499; 90410500; 90410501; 90410502; 90410503; 90410521; 90410522; 90410524; 90410526; 90410527; 90410531; 90410533; 90410534; 90410535; 90410550; 90410551; 90410552; 90410568; 90410571; 90410572; 90410573; 90410575; 90410576; 90410577; 90410580; 90410581; 90410582; 90410584; 90410585; 90410592; 90410596; 90410599; 90410600; 90410605; 90410606; 90410607; 90410608; 90410609; 90410610; 90410611; 90410612; 90410626; 90410638; 90410640; 90410642; 90410644; 90410646; 90410647; 90410650; 90410651; 90410652; 90410653; 90410656; 90410659; 90410660; 90410661; 90410662; 90410663; 90410664; 90410665; 90410666; 90410667; 90410668; 90410670; 90410700; 90410708; 90410846; 90410750; 90410786",,"63","It has come to the attention of MAQUET that in certain rare instances, the CARDIOHELP-i device may display an error message with audible alarm, indicating ''battery defective.'' The alarm will occur-upon start up or when the main power supply is unplugged from the main power source. The human machine interface touch screen of the CARDIOHELP-i device may gradually become black due to the human machine interface (HMI) back light shutting down. ",9/12/2013,"09/12/2013",11/6/2013,"11/06/2013"
"Devices",66337,"Ongoing","Xoran Technologies, Inc.","Ann Arbor","MI","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution - Nationwide","Z-0037-2014","Class II","Xoran MiniCAT CT Scanner","Minicat",,"320","A description of the defect in the product or the manner in which the product fails to comply wvith an applicable Federal standard; The MiniCAT CT Scanners subject to this notification failed to meet Xoran's specifications for dose rate of 125 3 kVp. These 18 complaints received include dose rates both on the high and low end of Xoran's specifications. See ATTACHMENT 1 for details. (e) A n evaluation of the hazards reasonably related to defect or the failure to comply with the Federal standard; An evaluation of the health hazard was performed on the issue of dose rate/kVp being found outside Xoran's specifications on the MiniCAT CT Scanners. Xoran specifies that the dose rate must be within a tight range. This range is smaller than what is specified as passing by West Physics. West Physics had stated in a report ''For this test, a measured effective dose of less than 0.4 mSv is considered satisfactory, and a measured does of greater than 0.23 mSv (but less than 0.4 mSv) will be investigated for possible corrective action.'' A scanner that falls outside the Xoran specification of 0.23 mSv does not present a danger to the patient. ",7/27/2010,"07/27/2010",11/6/2013,"11/06/2013"
"Devices",66338,"Ongoing","Xoran Technologies, Inc.","Ann Arbor","MI","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution - US nationwide","Z-0038-2014","Class II","Xoran Minicat00202","minicat",,"320","The MiniCAT CT Scanners subject to this notification failed to meet Xoran's specifications for dose rate of 125 3 kVp. These 18 complaints received include dose rates both on the high and low end of Xoran's specifications. See ATTACHMENT 1 for details. (e) A n evaluation of the hazards reasonably related to defect or the failure to comply with the Federal standard; An evaluation of the health hazard was performed on the issue of dose rate/kVp being found outside Xoran's specifications on the MiniCAT CT Scanners. Xoran specifies that the dose rate must be within a tight range. This range is smaller than what is specified as passing by West Physics. West Physics had stated in a report ''For this test, a measured effective dose of less than 0.4 mSv is considered satisfactory, and a measured does of greater than 0.23 mSv (but less than 0.4 mSv) will be investigated for possible corrective action.'' A scanner that falls outside the Xoran specification of 0.23 mSv does not present a danger to the patient. A copy of the health hazard evaluation may be found in ATTACHMENT 2.",7/27/2010,"07/27/2010",11/6/2013,"11/06/2013"
"Devices",66338,"Ongoing","Xoran Technologies, Inc.","Ann Arbor","MI","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution - US nationwide","Z-0039-2014","Class II","Xoran Minicat00158","minicat",,,"The MiniCAT CT Scanners subject to this notification failed to meet Xoran's specifications for dose rate of 125 3 kVp. These 18 complaints received include dose rates both on the high and low end of Xoran's specifications. See ATTACHMENT 1 for details. (e) A n evaluation of the hazards reasonably related to defect or the failure to comply with the Federal standard; An evaluation of the health hazard was performed on the issue of dose rate/kVp being found outside Xoran's specifications on the MiniCAT CT Scanners. Xoran specifies that the dose rate must be within a tight range. This range is smaller than what is specified as passing by West Physics. West Physics had stated in a report ''For this test, a measured effective dose of less than 0.4 mSv is considered satisfactory, and a measured does of greater than 0.23 mSv (but less than 0.4 mSv) will be investigated for possible corrective action.'' A scanner that falls outside the Xoran specification of 0.23 mSv does not present a danger to the patient. A copy of the health hazard evaluation may be found in ATTACHMENT 2.",7/27/2010,"07/27/2010",11/6/2013,"11/06/2013"
"Devices",66339,"Ongoing","Fresenius Medical Care Holdings, Inc.","Waltham","MA","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","USA Nationwide Distribution","Z-0148-2014","Class II","Fresenius Liberty Cycler Part Number: RTLR180111 Product Usage: The Liberty cycler is a portable device designed to perform acute and chronic peritoneal dialysis. ","All serial numbers",".","16,600","Fluid leaking may be observed inside the pump compartment of the Liberty Cycler and may result in dialysate becoming contaminated, potentially causing peritonitis",10/14/2013,"10/14/2013",11/13/2013,"11/13/2013"
"Devices",66340,"Ongoing","Xoran Technologies, Inc.","Ann Arbor","MI","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution - Nationwide","Z-0040-2014","Class II","Xoran MiniCAT00202","minicat",,"320","The MiniCAT CT Scanners subject to this notification failed to meet Xoran's specifications for dose rate of 125 3 kVp. These 18 complaints received include dose rates both on the high and low end of Xorans specifications.",7/27/2010,"07/27/2010",11/6/2013,"11/06/2013"
"Devices",66341,"Ongoing","GE Healthcare Beijing , Hangwei Medical Systems, Co. LTD","Beijing",,"CN","Voluntary: Firm Initiated","Letter","Worldwide Distribution - USA (nationwide) and Internationally to China, India, Japan, Malaysia, Australia, Ireland, France, Germany, Spain, Hungary, Belgium, and Switzerland.","Z-0066-2014","Class II","GE Brivo OEC715/785/865 C-Arm, Models: 715 Prime, 785 Essential, and 865 Plus. The QEC Brivo Mobile C-Arm X-Ray Products are designed to provide digital spot film imaging and fluoroscopic image guidance for all adult and pediatric populations for orientations between patient anatomy and surgical instruments. The product is used for general surgical applications and musculoskeletal procedures to visualize, for example, implant localizations or needle positions for aspirations,injections or biopsy. ","GE Brivo OEC715: Serial Numbers B2S13001 ~ B2S13010. GE Brivo OEC785: Serial Numbers B3S13005 ~ B3S13008. GE Brivo OEC865: Serial Numbers B4S13001 ~ B4S13015",".","29","GE is recalling certain lots of GE Brivo OEC715/785/865 C-Arm due to the potential for the wires in the high voltage cable bundle to fail, resulting in loss of system functionality.",9/18/2013,"09/18/2013",10/30/2013,"10/30/2013"
"Drugs",66342,"Ongoing","W.S. Badger Company Inc.","Gilsum","NH","US","Voluntary: Firm Initiated","Letter","Nationwide and Canada, Greece, Singapore, Thailand, Norway, American Samoa.","D-324-2014","Class II","Badger Baby Broad Spectrum SPF 30 Zinc Oxide Sunscreen Lotion Chamomile & Calendula, 4fFl.oz Tube, UPC code: 634084490091 (US) UPC Code: 634084490114 (Canada)","Lot number 3024A EXP 01/15; 3057A EXP 02/15; 3063A EXP 03/15; 3063B EXP 03/15; 3132A; 3133A EXP 05/15. ",".","36,272 Tubes","Microbial Contamination of Non-Sterile Products; Selected lots of Badger Baby and Kids Sunscreen Lotion were recalled due to microbial contamination.",9/24/2013,"09/24/2013",12/11/2013,"12/11/2013"
"Drugs",66342,"Ongoing","W.S. Badger Company Inc.","Gilsum","NH","US","Voluntary: Firm Initiated","Letter","Nationwide and Canada, Greece, Singapore, Thailand, Norway, American Samoa.","D-325-2014","Class II","Badger Kids Broad Spectrum SPF30 Zinc Oxide Sunscreen Lotion Tangerine & Vanilla, 4 fl. oz.. Tube, UPC Code: 634084490145 (US), UPC code: 634084490169 (Canada)","Lot #: 3164A, Exp 06/15",".","5941 Tubes","Microbial Contamination of Non-Sterile Products; Selected lots of Badger Baby and Kids Sunscreen Lotion were recalled due to microbial contamination.",9/24/2013,"09/24/2013",12/11/2013,"12/11/2013"
"Food",66343,"Ongoing","Borinquen Natural","Carolina","PR","US","Voluntary: Firm Initiated","Visit","PR only.","F-0691-2014","Class II"," HCG Premium, Hormone-Free Drops 60 mL ","none",".","1418, total for all varieties","Distributed dietary supplements with the following claims: ''drops the fat, expels toxins, break down fat, block carbohydrates, suppresses appetite, suppresses fat absorption, creates a balance in the thyroid''. In addition, the firm's website claimed to repair body tissue, such as minor ulcers and to contain anti-cancer compounds.",9/9/2013,"09/09/2013",12/11/2013,"12/11/2013"
"Food",66343,"Ongoing","Borinquen Natural","Carolina","PR","US","Voluntary: Firm Initiated","Visit","PR only.","F-0693-2014","Class II","HCG Premium Cleanse Hormone-Free Drops with Acai Berry & Raspberry Ketone, 60 ml","none",".","1418, total for all varieties","Distributed dietary supplements with the following claims in the firm's website: ''prevents depression, hypertension, renal diseases, arthritis, cancer, diabetes, obesity, heart conditions, etc.''",9/9/2013,"09/09/2013",12/11/2013,"12/11/2013"
"Food",66343,"Ongoing","Borinquen Natural","Carolina","PR","US","Voluntary: Firm Initiated","Visit","PR only.","F-0692-2014","Class II","Moringa Premium 60 capsules","none",".","1418, total for all varieties","Distributed dietary supplements with the following claims in the firm's website: ''prevents depression, hypertension, renal diseases, arthritis, cancer, diabetes, obesity, heart conditions, etc.''",9/9/2013,"09/09/2013",12/11/2013,"12/11/2013"
"Food",66343,"Ongoing","Borinquen Natural","Carolina","PR","US","Voluntary: Firm Initiated","Visit","PR only.","F-0694-2014","Class II","HCG Premium Energy Hormone-Free Drops with B12, B6 & Yohimbine, 60 ml","none",".","1418, total for all varieties","Distributed dietary supplements with the following claims in the firm's website: ''prevents depression, hypertension, renal diseases, arthritis, cancer, diabetes, obesity, heart conditions, etc.''",9/9/2013,"09/09/2013",12/11/2013,"12/11/2013"
"Devices",66344,"Ongoing","Xoran Technologies, Inc.","Ann Arbor","MI","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution - US nationwide","Z-0041-2014","Class II","Xoran MiniCAT CT Scanner ID ENT00001","minicat",,"320","Failure of the gantry to rotate. The complaint alleged that the scanner would emit radiation but would not rotate. ",12/14/2009,"12/14/2009",11/6/2013,"11/06/2013"
"Devices",66347,"Ongoing","DeVilbiss Healthcare LLC","Somerset","PA","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution - USA and the countries of Mexico and Canada.","Z-2319-2013","Class II","DeVilbiss Vacu-Aide QSU Suction Unit (Disposable Suction Container/Filter), 800 ML DISP Container, Unassembled, 800 ML DISP Container w/6' patient tubing, and 800 ML DISP Container w/6' patient tubing, assembled. DeVilbiss Vacu-Aide QSU Suction Unit (Disposable Suction Container/Filter) is used to remove fluids from the airway or respiratory support system and infectious materials from wounds. It is available for use by consumers by physician order.","Part Number 7305D-634 with model numbers 7305D-632, 7305D-633, and 7305D-633-25",,"112,849","End users of the DeVilbiss Disposable Suction Container/Filter had exposed the bacterial filter cartridge to fluid, thereby occluding the filter and rendering it unusable. ",3/7/2013,"03/07/2013",10/9/2013,"10/09/2013"
"Biologics",66348,"Terminated","St Mary's Hospital and Medical Center, Inc.","Grand Junction","CO","US","Voluntary: Firm Initiated","Telephone","Colorado","B-0078-14","Class III","Red Blood Cells Leukocytes Reduced","W056312012498, W056312012501, W056312012494, W056312012493 ",".","4 units","Blood products, for which the expiration date was extended by one day, were distributed.",9/13/2012,"09/13/2012",12/11/2013,"12/11/2013"
"Biologics",66349,"Terminated","St Mary's Hospital and Medical Center, Inc.","Grand Junction","CO","US","Voluntary: Firm Initiated","Telephone","Colorado","B-0079-14","Class III","Red Blood Cells Leukocytes Reduced","W056312010194",".","1 unit","Blood product, for which the expiration date was extended by one day, was distributed.",9/13/2012,"09/13/2012",12/11/2013,"12/11/2013"
"Biologics",66350,"Terminated","Community Blood Center Of Gtr KC","Kansas City","MO","US","Voluntary: Firm Initiated","Telephone","Kansas","B-0077-14","Class II","Platelets Pheresis Leukocytes Reduced","W045013904618",".","1 unit","Blood product, which was not tested for pH and residual White Blood Cell count, was distributed.",7/22/2013,"07/22/2013",12/11/2013,"12/11/2013"
"Devices",66351,"Ongoing","Smiths Medical ASD, Inc.","Keene","NH","US","Voluntary: Firm Initiated","Letter","Nationwide Distribution including AK, AR, AZ, CA, CT, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, NC, NE, NJ, NY, OH, OK, OR, PA, RI, SC, TX, UT, VA, VT, WA, WI, WY.","Z-0158-2014","Class II","Portex Spinal Tray with Drugs 25g Whitacre; 15545C-21 The Regional Anesthesia family of products is comprised of sterile (unless otherwise indicated in the product scope), single-use devices designed to perform epidural, spinal, combined epidural/spinal, nerve block, lumbar puncture and regional anesthesia procedures. The spinal products are comprised of spinal needles, introducer needles and accessories required to perform a spinal procedure. ","Lot Number: 2440517",".","830","Visual particulate in the glass ampules of 5% Lidocaine HCL and 7.5% Dextrose Injection, USP, 2 mL Ampoule, NDC # 0409-4712-01, Hospira Lot Number 23-227-DK. These ampules are included in certain Portex Spinal Anaesthesia Trays. ",9/23/2013,"09/23/2013",11/13/2013,"11/13/2013"
"Devices",66351,"Ongoing","Smiths Medical ASD, Inc.","Keene","NH","US","Voluntary: Firm Initiated","Letter","Nationwide Distribution including AK, AR, AZ, CA, CT, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, NC, NE, NJ, NY, OH, OK, OR, PA, RI, SC, TX, UT, VA, VT, WA, WI, WY.","Z-0162-2014","Class II","Portex Saddleblock Tray with Drugs 26g Quincke, 4745-20 The Regional Anesthesia family of products is comprised of sterile (unless otherwise indicated in the product scope), single-use devices designed to perform epidural, spinal, combined epidural/spinal, nerve block, lumbar puncture and regional anesthesia procedures. The spinal products are comprised of spinal needles, introducer needles and accessories required to perform a spinal procedure. ","Lot: 2445619",".","100","Visual particulate in the glass ampules of 5% Lidocaine HCL and 7.5% Dextrose Injection, USP, 2 mL Ampoule, NDC # 0409-4712-01, Hospira Lot Number 23-227-DK. These ampules are included in certain Portex Spinal Anaesthesia Trays. ",9/23/2013,"09/23/2013",11/13/2013,"11/13/2013"
"Devices",66351,"Ongoing","Smiths Medical ASD, Inc.","Keene","NH","US","Voluntary: Firm Initiated","Letter","Nationwide Distribution including AK, AR, AZ, CA, CT, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, NC, NE, NJ, NY, OH, OK, OR, PA, RI, SC, TX, UT, VA, VT, WA, WI, WY.","Z-0163-2014","Class II","Portex Saddleblock Tray with Drugs 22g Quincke (Without Introducer); 4792-20 The Regional Anesthesia family of products is comprised of sterile (unless otherwise indicated in the product scope), single-use devices designed to perform epidural, spinal, combined epidural/spinal, nerve block, lumbar puncture and regional anesthesia procedures. The spinal products are comprised of spinal needles, introducer needles and accessories required to perform a spinal procedure. ","Lot: 2450793",".","200","Visual particulate in the glass ampules of 5% Lidocaine HCL and 7.5% Dextrose Injection, USP, 2 mL Ampoule, NDC # 0409-4712-01, Hospira Lot Number 23-227-DK. These ampules are included in certain Portex Spinal Anaesthesia Trays. ",9/23/2013,"09/23/2013",11/13/2013,"11/13/2013"
"Devices",66351,"Ongoing","Smiths Medical ASD, Inc.","Keene","NH","US","Voluntary: Firm Initiated","Letter","Nationwide Distribution including AK, AR, AZ, CA, CT, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, NC, NE, NJ, NY, OH, OK, OR, PA, RI, SC, TX, UT, VA, VT, WA, WI, WY.","Z-0159-2014","Class II","Portex Regional Anesthesia Tray with Drugs; 15548-20 The Regional Anesthesia family of products is comprised of sterile (unless otherwise indicated in the product scope), single-use devices designed to perform epidural, spinal, combined epidural/spinal, nerve block, lumbar puncture and regional anesthesia procedures. The spinal products are comprised of spinal needles, introducer needles and accessories required to perform a spinal procedure. ","Lot Number: 2450807",".","100","Visual particulate in the glass ampules of 5% Lidocaine HCL and 7.5% Dextrose Injection, USP, 2 mL Ampoule, NDC # 0409-4712-01, Hospira Lot Number 23-227-DK. These ampules are included in certain Portex Spinal Anaesthesia Trays. ",9/23/2013,"09/23/2013",11/13/2013,"11/13/2013"
"Devices",66351,"Ongoing","Smiths Medical ASD, Inc.","Keene","NH","US","Voluntary: Firm Initiated","Letter","Nationwide Distribution including AK, AR, AZ, CA, CT, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, NC, NE, NJ, NY, OH, OK, OR, PA, RI, SC, TX, UT, VA, VT, WA, WI, WY.","Z-0157-2014","Class II","Portex Spinal Tray with Drugs 22g/25g Quincke; 15249-21 The Regional Anesthesia family of products is comprised of sterile (unless otherwise indicated in the product scope), single-use devices designed to perform epidural, spinal, combined epidural/spinal, nerve block, lumbar puncture and regional anesthesia procedures. The spinal products are comprised of spinal needles, introducer needles and accessories required to perform a spinal procedure. ","Lot Number: 2445601",".","73","Visual particulate in the glass ampules of 5% Lidocaine HCL and 7.5% Dextrose Injection, USP, 2 mL Ampoule, NDC # 0409-4712-01, Hospira Lot Number 23-227-DK. These ampules are included in certain Portex Spinal Anaesthesia Trays. ",9/23/2013,"09/23/2013",11/13/2013,"11/13/2013"
"Devices",66351,"Ongoing","Smiths Medical ASD, Inc.","Keene","NH","US","Voluntary: Firm Initiated","Letter","Nationwide Distribution including AK, AR, AZ, CA, CT, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, NC, NE, NJ, NY, OH, OK, OR, PA, RI, SC, TX, UT, VA, VT, WA, WI, WY.","Z-0160-2014","Class II","Portex Spinal Tray with Drugs 25g Whitacre; 15597-20 The Regional Anesthesia family of products is comprised of sterile (unless otherwise indicated in the product scope), single-use devices designed to perform epidural, spinal, combined epidural/spinal, nerve block, lumbar puncture and regional anesthesia procedures. The spinal products are comprised of spinal needles, introducer needles and accessories required to perform a spinal procedure. ","Lot: 2445604, 2440523, 2445605, 2445606, 2450812",".","3980","Visual particulate in the glass ampules of 5% Lidocaine HCL and 7.5% Dextrose Injection, USP, 2 mL Ampoule, NDC # 0409-4712-01, Hospira Lot Number 23-227-DK. These ampules are included in certain Portex Spinal Anaesthesia Trays. ",9/23/2013,"09/23/2013",11/13/2013,"11/13/2013"
"Devices",66351,"Ongoing","Smiths Medical ASD, Inc.","Keene","NH","US","Voluntary: Firm Initiated","Letter","Nationwide Distribution including AK, AR, AZ, CA, CT, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, NC, NE, NJ, NY, OH, OK, OR, PA, RI, SC, TX, UT, VA, VT, WA, WI, WY.","Z-0161-2014","Class II","Portex Spinal Tray with Drugs 25g Whitacre; 15597C-20 The Regional Anesthesia family of products is comprised of sterile (unless otherwise indicated in the product scope), single-use devices designed to perform epidural, spinal, combined epidural/spinal, nerve block, lumbar puncture and regional anesthesia procedures. The spinal products are comprised of spinal needles, introducer needles and accessories required to perform a spinal procedure. ","Lot: 2426443, 2431124, 2440524, 2450808",".","1904","Visual particulate in the glass ampules of 5% Lidocaine HCL and 7.5% Dextrose Injection, USP, 2 mL Ampoule, NDC # 0409-4712-01, Hospira Lot Number 23-227-DK. These ampules are included in certain Portex Spinal Anaesthesia Trays. ",9/23/2013,"09/23/2013",11/13/2013,"11/13/2013"
"Devices",66351,"Ongoing","Smiths Medical ASD, Inc.","Keene","NH","US","Voluntary: Firm Initiated","Letter","Nationwide Distribution including AK, AR, AZ, CA, CT, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, NC, NE, NJ, NY, OH, OK, OR, PA, RI, SC, TX, UT, VA, VT, WA, WI, WY.","Z-0164-2014","Class II","Portex Saddleblock Tray with Drugs 25g Quincke; 4795-20 The Regional Anesthesia family of products is comprised of sterile (unless otherwise indicated in the product scope), single-use devices designed to perform epidural, spinal, combined epidural/spinal, nerve block, lumbar puncture and regional anesthesia procedures. The spinal products are comprised of spinal needles, introducer needles and accessories required to perform a spinal procedure. ","Lot: 2455104",".","222","Visual particulate in the glass ampules of 5% Lidocaine HCL and 7.5% Dextrose Injection, USP, 2 mL Ampoule, NDC # 0409-4712-01, Hospira Lot Number 23-227-DK. These ampules are included in certain Portex Spinal Anaesthesia Trays. ",9/23/2013,"09/23/2013",11/13/2013,"11/13/2013"
"Devices",66351,"Ongoing","Smiths Medical ASD, Inc.","Keene","NH","US","Voluntary: Firm Initiated","Letter","Nationwide Distribution including AK, AR, AZ, CA, CT, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, NC, NE, NJ, NY, OH, OK, OR, PA, RI, SC, TX, UT, VA, VT, WA, WI, WY.","Z-0156-2014","Class II","Portex Spinal Tray with Drugs 22g Whitacre/25g Whitacre; 15248C-22/25 The Regional Anesthesia family of products is comprised of sterile (unless otherwise indicated in the product scope), single-use devices designed to perform epidural, spinal, combined epidural/spinal, nerve block, lumbar puncture and regional anesthesia procedures. The spinal products are comprised of spinal needles, introducer needles and accessories required to perform a spinal procedure. ","Lot Number: 2440516",".","140","Visual particulate in the glass ampules of 5% Lidocaine HCL and 7.5% Dextrose Injection, USP, 2 mL Ampoule, NDC # 0409-4712-01, Hospira Lot Number 23-227-DK. These ampules are included in certain Portex Spinal Anaesthesia Trays. ",9/23/2013,"09/23/2013",11/13/2013,"11/13/2013"
"Devices",66352,"Ongoing","Stryker Instruments Div. of Stryker Corporation","Portage","MI","US","Voluntary: Firm Initiated","Letter","Worldwide distribution: US (nationwide) and countries of: Australia, Canada, France, Germany, Italy, Japan, Spain, Switzerland, and United Kingdom.","Z-0092-2014","Class II","REF 5100-088, TPS Micro Driver, For Use with Stryker Total Performance System Caution Federal Law (USA) restricts the device to use by or on the order of a physician Driver, Wire and Bone Drill; The Stryker Total Performance System (TPS) is intended for use in the cutting, drilling, reaming, decorticating and smoothing of bone and other bone related tissues for a variety of applications such as ENT, dental, orthopedic, maxillofacial, spinal, and plastic surgery. The instruments are also used in the placement of screws, wires, pins, and other fixation devices. ","10933, 11433, 11483, 20553, 30163, 31553, 40713, 40833, 41113, 50463, 60133, 60423, 90383, 110093, 110193, 1030133, 1030403, 1040413, 2010013, 2010123, 96090403, 96091343, 97020193, 97030013, 97030543, 97050243, 97060163, 97080033, 98010083, 98020703, 98030103, 98040213, 98060023, 98061033, 98070603, 98090023, 98090473, 98090503, 98101143, 98110323, 99010433, 99030253, 99050033, 99050383, 99060163, 99060423, 99061063, 99061283, 99070453, 99071293, 99080243, 99080483, 99090913, 99101273, 221303733, 326102033, 434909453, 500800103, 504900233, 631112793, 631414853, 700314923, 723606673, 725315933, 735502183, 813304543, and 921700523 , ",,"67","It was discovered that the silicone potting failed to properly cure after undergoing the prescribed curing possess. The potting material is used to insulate, stabilize and provide a moisture barrier to the TPS MicroDriver main Printed Circuit Board Assembly (PCBA). Inadequate cure of the silicone potting could potentially allow it to leak to the outside of the handpiece or cause an electrical malfunction (primarily loss of function). Two batches of silicone potting have been identified, by the supplier, as having cure properties that were outside of the specified range. ",10/2/2013,"10/02/2013",11/6/2013,"11/06/2013"
"Devices",66353,"Ongoing","ITC-Nexus Dx","Edison","NJ","US","Voluntary: Firm Initiated","Telephone","Nationwide Distribution including Arizona andTexas. .","Z-0137-2014","Class II","Surgicutt fully automated incision making device for bleeding time determination. ITC 8 Olsen Avenue, Edison, NJ 08820. 732.548.5700. www.itcmed.com. A subsidiary of Thoratec Corporation. The device is a spring loaded cam driven device that provides standardized incisions of 5 mm length and 1 mm depth. This fully automated instrument is used along with blotting paper for bleeding time determinations. ","Product Code: SUB50I; Lot No. AK301M. Lot Expiration Date 8/31/2017",".","6 boxes (Each box contains 50 Surgicutt Devices plus 55 sheets of Blotting Paper).","ITC has determined that the blade in their Surgicutt with Blotting Paper (Product Code: SUB50I; Lot: AK301M) devices may be loose. ",8/22/2013,"08/22/2013",11/13/2013,"11/13/2013"
"Food",66354,"Ongoing","NatureMost of New England, Inc.","Middletown","CT","US","Voluntary: Firm Initiated","Letter","Strawberry Banana: GA.,MA.,CT.,AR.,NY.,NJ.,MD.,NH.,TX., CA., FL; Vanilla Almond: GA, NC.,MA.,CT.,AR.,NY.,RI.,NJ.,MN.,SC.,AZ.,OH.,MD.,IN.,NH.,TX. St. Thoms, USVI","F-0079-2014","Class I","NatureMost LABORATORIES NATURAL WHEY POWER W / YERBA MATE STRAWBERRY / BANANA Dietary Supplement NET WEIGHT 3 LBS. (1362g). ","Lot Numbers: 9954/3793, 9954/4043, 9954/4205, 9954/4861 ",".","211 units","Undeclared allergens, milk and soy. ",6/5/2013,"06/05/2013",10/30/2013,"10/30/2013"
"Food",66354,"Ongoing","NatureMost of New England, Inc.","Middletown","CT","US","Voluntary: Firm Initiated","Letter","Strawberry Banana: GA.,MA.,CT.,AR.,NY.,NJ.,MD.,NH.,TX., CA., FL; Vanilla Almond: GA, NC.,MA.,CT.,AR.,NY.,RI.,NJ.,MN.,SC.,AZ.,OH.,MD.,IN.,NH.,TX. St. Thoms, USVI","F-0078-2014","Class I","NatureMost LABORATORIES NATURAL WHEY POWER W / YERBA MATE VANILLA / ALMOND Dietary Supplement NET WEIGHT 3 LBS. (1362g). Product Number: 9950","Lot Numbers: 9950/3491, 9950/3636, 9950/3766, 9950/4011, 9950/4374, 9950/5025, 9950/5559",".","370 units","Undeclared allergens, milk,almond and soy. ",6/5/2013,"06/05/2013",10/30/2013,"10/30/2013"
"Devices",66355,"Completed","Medtronic Xomed, Inc.","Jacksonville","FL","US","Voluntary: Firm Initiated","Telephone","Nationwide Distribution (US), including the states of CA, NE, GA, and IL.","Z-2284-2013","Class II","Universal Titanium Prosthesis, Round Head, with Flex H/A titanium shoe. The ear prosthesis is implantable and indicated for hearing loss.","REF: 1150000 Lot: 0207029284",".","60","One lot of the product was assembled using the Cam Head version of the same prosthesis instead of the Round head Shaft.",8/23/2013,"08/23/2013",10/2/2013,"10/02/2013"
"Drugs",66356,"Ongoing","Valeant Pharmaceuticals North Am","Bridgewater","NJ","US","Voluntary: Firm Initiated","Letter","United States","D-020-2014","Class III","Acanya (Clindamycin Phosphate and Benzoyl Peroxide) Gel 1.2% and 2.5%. Rx Only, Net Wt 3.5 g, Sample - not for sale, CORIA Laboratories, a division of Valeant Pharmaceuticals LLC, Bridgewater, NJ 08807 --- NDC 13548-132-03","Lot AC27198F6",".","45,000 tubes","Labeling: Incorrect or Missing Lot and/or Exp Date: This recall is being carried out due to an incorrect expiration date assigned to a lot of physicians samples.",9/20/2013,"09/20/2013",12/4/2013,"12/04/2013"
"Devices",66357,"Ongoing","ASO, LLC","Sarasota","FL","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Distributed in the states of ID, WI, IN, and NE.","Z-0004-2014","Class II","SHOPKO Waterproof Adhesive Pads Antibacterial. Used for covering minor cuts, scrapes and burns.","UPC Code #: 400129133311 Lot numbers: 330543 and 341383",,"37 cases (72 retail boxes in each case)","No antibacterial bandages were packed in boxes labeled as antibacterial.",8/21/2013,"08/21/2013",10/9/2013,"10/09/2013"
"Devices",66359,"Ongoing","Ivoclar Vivadent, Inc.","Buffalo","NY","US","Voluntary: Firm Initiated","Telephone","US Distribution: including states of PA, WA, WI, NY, LA, TX, NJ, CA, OR, IA, SC, IN, IL, and AZ.","Z-0376-2014","Class II","ExciTE F DSC Soft touch Single Dose, Dual-curing Regular Ref. 50 dental adhesive for restorations ","Product Code 630378AN; Lot Number: R59595; Expiration date of 3 January 2015",,"63 refill packs (50 single use applications per refill)","Ivoclar Vivadent, Inc. is recalling a lot of ExciTE F DSC Dental Adhesive found to produce a blue green discoloration when used in combination with cements.",9/23/2013,"09/23/2013",11/27/2013,"11/27/2013"
"Drugs",66360,"Ongoing","Watson Laboratories Inc","Corona","CA","US","Voluntary: Firm Initiated","Letter","US. No international. NATIONWIDE","D-66360-001","Class II","Next Choice'' One Dose Emergency Contraceptive (Levonorgestrel Tablet), 1.5 mg, 1 Tablet/Blister Card (NDC 52544-287-54), Manufactured by Watson Laboratories Inc, 132 Business Center Drive, Corona, CA 92880. ","Lot#: 580974AA and 580975AA. Exp: 09/14 ",".","1,002,394 tablets","Failed Tablet/Capsule Specifications: Multiple complaints for push through tablet breakage.",9/23/2013,"09/23/2013",10/16/2013,"10/16/2013"
"Devices",66361,"Ongoing","Convergent Dental","Natick","MA","US","Voluntary: Firm Initiated","E-Mail","US distribution including states of: MA, CT, NY.","Z-0050-2014","Class II","Solea 1.0 Laser Surgical instrument for use in general and plastic surgery and dermatology.","Serial Numbers: CDS1-DVSU-1B-JU-13; CDS1-7QRE-1B-JU-13; CDS1-22TZ-1B-JU-13; CDS1-PNJZ-1B-AU-13; CDS1-A4CQ-1B-AU-13 ",".","5","Specific error condition could lead to unintended laser emission during laser activation. ",9/12/2013,"09/12/2013",10/30/2013,"10/30/2013"
"Devices",66362,"Ongoing","Small Bone Innovations, Inc.","Morrisville","PA","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution-USA (nationwide) and the countries of Canada and Mexico.","Z-0098-2014","Class II","Small Bone Innovations (SBi) rHead Radial Stem, rHead Recon Radial System, rHead Radial Stem Lateral Assembly, rHead Radial Stem 6mm Collar, rHead Recon Radial Stem 6mm Collar, rHead Radial Stem Lateral Assembly 6mm Collar, rHead Standard Extended Stem, rHead Radial Stem Plasma Coated, rHead Recon Radial Stem Plasma Coated, rHead Radial Stem 6mm Collar Plasma Coated, rHead Recon Radial Stem 6mm Collar Plasma Coated, uHead Ulnar Stem Standard, uHead Ulnar Stem 20mm Collar packaged in a sterile pouch inside a shrink-wrapped box.","all item numbers and lot numbers",,"1984 devices","The recall was initiated due to an increased risk of implants breaching the sterile pouches inside the shrink-wrapped box. ",9/6/2013,"09/06/2013",11/6/2013,"11/06/2013"
"Devices",66363,"Ongoing","Siemens Healthcare Diagnostics, Inc.","Newark","DE","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution - US Distribution including the states of OH, MD, CO, NJ, IA, NC, VA, WI and DC., and the countries of Austria, Denmark, France, Italy, Netherlands and Norway.","Z-0541-2014","Class II","Siemens Dimension Vista Homocysteine Flex Reagent Cartridge The HCYS method is an in vitro diagnostic test for the quantitative measurement of total homocysteine in human serum, heparinized plasma and ETDA plasma on the Dimension Vista System. Measurements of homocysteine aid in the diagnosis and treatment of patients suspected of having hyperhomocysteinemia and homocystinuria. ","lot 13064MA, expiration 2014-03-05",".","302","Dimension Vista HCYS lot 13064MA shows erratic recovery of QC and patient samples. ",9/18/2013,"09/18/2013",12/26/2013,"12/26/2013"
"Devices",66365,"Ongoing","Maquet Cardiovascular, LLC","Wayne","NJ","US","Voluntary: Firm Initiated","Letter","USA Nationwide Distribution in the states of: Florida, Maryland, New Jersey, New York and Texas.","Z-0001-2014","Class II","Ultima OPCAB System, Sterile, Rx Only, Product Usage: Intended for use during performance of minimally invasive cardiac surgery through a sternotomy incision approach. The ULTIMA Access RailPlatform in combination with the Activator II Drive Mechanism is used to spread the sternum, providing access and direct visualization to the thoracic cavity. The AccessRail Platform also allows for the organization of pericardial sutures. The ULTIMA Stablizer isolates and provides local immobilization of the target vessel on the beating heart. ","ULTIMA OPCAB System Part Nos. OM-2003S (LOT #25052176) and OM-2001D (LOT #25052200).",,"20 units (Lot 25052176); 12 units (Lot #25052200)","MAQUET has identified a potential issue with the ULTIMA OPCAB (part numbers OM-2003S & OM-2001D). Labeling for the 2 blade lots had been incorrectly applied. The standard blades from Lot #25052176 were incorrectly labeled as deep blades, and the 20 deep blades from Lot #25052200 were incorrectly labeled as standard blades.",9/20/2013,"09/20/2013",10/9/2013,"10/09/2013"
"Biologics",66366,"Terminated","Community Blood Bank of Erie County","Erie","PA","US","Voluntary: Firm Initiated","Telephone","Pennsylvania","B-0075-14","Class II","Platelets Pooled Leukocytes Reduced","W045613300485; ",".","1","Blood product, labeled leukoreduced which did not meet the requirements for a leukoreduced product, was distributed.",8/16/2013,"08/16/2013",12/11/2013,"12/11/2013"
"Biologics",66367,"Terminated","Central Pennsylvania Blood Bank","Hummelstown","PA","US","Voluntary: Firm Initiated","FAX","Pennsylvania","B-0074-14","Class II","Red Blood Cells Leukocytes Reduced","W270113503329; ",".","1","Blood product, collected from a donor who reported travel to a malarial endemic area, was distributed.",8/20/2013,"08/20/2013",12/11/2013,"12/11/2013"
"Devices",66368,"Ongoing","Baylis Medical Corp *","Montreal",,"CA","Voluntary: Firm Initiated","Letter","Worldwide Distribution - USA Nationwide in the states of : NE, NH, NC, FL, PA, VA, MI, CA, AL, and TN and the countries of China, Canada, Saudi Arabia, and Italy.","Z-0085-2014","Class I","Baylis Medical TorFlex Transseptal Guiding Sheath, Rx Only, non-pyrogenic, sterile. Product Usage: The TorFlex Transseptal Guiding Sheath kit (K102948) is a single use device consisting of three components: a sheath, a dilator, and a J-tipped guidewire. The kit is designed for safe and easy catheterization and angiography of specific heart chambers and locations.","Part No. TF8-32-63-135, Lot TFFB070912; Part No.TF8-32-63-37, Lot TFFA310812; Part. No. TF8-32-63-37, Lot TFFB290113; Part No. TF8-32-63-45, Lot TFFA290113; Part No. TF8-32-63-45, Lot TFFB310812; Part No. TF8-32-63-45, Lot TFFC221211; Part No. TF8-32-63-55, Lot TFFA051212; Part No. TF8-32-63-55, Lot TFFA230812; Part No. TF8-32-63-55, Lot TFFB221211; Part No. TF8-32-63-55, Lot TFFB230113; Part No. TF8-32-63-90, Lot TFFA070213; Part No. TF8-32-63-90, Lot TFFA070912; Part No. TF8-32-81-135, Lot TFFH070912; Part No. TF8-32-81-37, Lot TFFD070912; Part No. TF8-32-81-45, Lot TFFE070912; Part No. TF8-32-81-55, Lot TFFF070912; Part No. TF8-32-81-90, Lot TFFG070912; Part No. TF8-38-62-S, Lot TFFA201212; Part No. TF85-32-63-37, Lot TFFC070912; Part No. TF85-32-63-45, Lot TFFA221211; Part No. TF85-32-63-45, Lot TFFA250512; Part No. TF85-32-63-45, Lot TFFC051212; Part No. TF85-32-63-45, Lot TFFC230812; Part No. TF85-32-63-55, Lot TFFA230113; Part No. TF85-32-63-55, Lot TFFA290812; Part No. TF85-32-63-55, Lot TFFB070612; Part No. TF85-32-63-90, Lot TFFB230812; Part No. TF85-32-63-90, Lot TFFC260413; Part No. TF85-32-63-90, Lot TFFC280213; Part No. TF85-32-63-90, Lot TFFF070213; Part No. TF85-32-81-135, Lot TFFC280912; Part No. TF85-32-81-37, Lot TFFA280912; and Part No. TF85-32-81-90, Lot TFFB280912",".","370 devices","The TorFlex Transseptal Guiding Sheath Kits are being recalled due to the possibility that the sheath could remove particulate of less than 5 mm from the dilator. The particulate could potentially migrate into a patients bloodstream. ",9/23/2013,"09/23/2013",11/13/2013,"11/13/2013"
"Food",66369,"Ongoing","American Nut Company","Sylmar","CA","US","Voluntary: Firm Initiated","Letter","CA, AZ, & WA","F-1944-2013","Class II","Fancy Mixed Nuts (25lbs), Mixed Nuts (25lbs), and Super King Fancy Mixed Nuts (25lbs)","Fancy Mixed Nuts: LOT2013.09.09 Mixed Nuts: LOT2013.09.12 Super King Fancy Mixed Nuts: LOT2013.08.23 ",".","111 cases","American Nuts is recalling Mixed Nuts because they may contain undeclared wheat allergen.",9/23/2013,"09/23/2013",10/2/2013,"10/02/2013"
"Food",66370,"Ongoing","J M Smucker Co","Orrville","OH","US","Voluntary: Firm Initiated","Letter","Product was shipped to the following states: AL, AR, AZ, CA, CO, FL, GA, HI, IL, IN, KS, KY, LA, MD, ME, MO, MS, NC, NE, NM, NY, NV, OH, OK, PA, SC, TN, TX, UT, VA, WA, WI and WY.","F-0111-2014","Class II","Martha White Buttermilk Cornmeal Self-Rising, White, Enriched NET WT 5 LB (2.26kg) Paper Bag Mfg Code 3152 511 BEST IF USED BY: 1-Feb-14; White Lily Buttermilk Cornmeal Self-Rising, White, Enriched NET WT 32 OZ (2 lb) 907g Paper Bag Mfg Code 3157 511 BEST IF USED BY: 6-Feb-14; Martha White Buttermilk Cornmeal Self-Rising, White, Enriched NET WT 32 OZ (2 lb) 907g Paper Bag Mfg Code 3191 511 BEST IF USED BY: 10-Mar-14 Product labeled in part, INGREDIENTS: ENRICHED WHITE CORN MEAL, WHEAT FLOUR AND DEGERMINATED WHITE CORN MEAL***BAKING POWDER***SALT***CONTAINS: MILK AND WHEAT INGREDIENTS***DISTRIBUTED BY: MARTHA WHITE FOODS INC. P.O. BOX 751030, MEMPHIS, TN 38175***0 13300 18601 5","3152 511 BEST IF USED BY: 1-Feb-14; 3157 511 BEST IF USED BY: 6-Feb-14; 3191 511 BEST IF USED BY: 10-Mar-14",".","7184 cases-8 units per case; 1497 cases-12 units per case; 4773 cases-12 units per case","The states of Alabama and North Carolina through independent testing notified JM Smucker that aflatoxin levels exceeded FDA specification (<20 ppb). Levels tested ranged from 30 ppb to 207 ppb.",9/23/2013,"09/23/2013",11/13/2013,"11/13/2013"
"Food",66370,"Ongoing","J M Smucker Co","Orrville","OH","US","Voluntary: Firm Initiated","Letter","Product was shipped to the following states: AL, AR, AZ, CA, CO, FL, GA, HI, IL, IN, KS, KY, LA, MD, ME, MO, MS, NC, NE, NM, NY, NV, OH, OK, PA, SC, TN, TX, UT, VA, WA, WI and WY.","F-0103-2014","Class II","Jim Dandy Iron Fortified Quick Grits, 1lb paper box, Labeled in part ''INGREDIENTS: IRON, WHITE CORN GRITS, NIACIN, THIAMIN, MONONITRATE, RIBOFLAVIN, FOLIC ACID. DISTRIBUTED BY: MARTHA WHITE FOODS, INC., P. O. BOX 751030 MEMPHIS, TN 38175***0 13300 11501 5***3067 511 Best If Used By 8-NOV-14***''","3067 211 Best If Used By 8-NOV-14",".","1,445 cs/12/1 lb boxes","The states of Alabama and North Carolina through independent testing notified JM Smucker that aflatoxin levels exceeded FDA specification (<20 ppb). Levels tested ranged from 30 ppb to 207 ppb.",9/23/2013,"09/23/2013",11/13/2013,"11/13/2013"
"Food",66370,"Ongoing","J M Smucker Co","Orrville","OH","US","Voluntary: Firm Initiated","Letter","Product was shipped to the following states: AL, AR, AZ, CA, CO, FL, GA, HI, IL, IN, KS, KY, LA, MD, ME, MO, MS, NC, NE, NM, NY, NV, OH, OK, PA, SC, TN, TX, UT, VA, WA, WI and WY.","F-0106-2014","Class II","Gladiola White Cornbread Mix, Net Wt 6 oz (170g) Laminated Pouch Mfg Code 3101 501 BEST IF USED BY: 11 APR 14 Product labeled in part, INGREDIENTS: ENRICHED DEGERMINATED WHITE CORN MEAL, AND ENRICHED BLEACHED FLOUR***PARTIALLY DEHYDROGENATED SOYBEAN OIL, DEXTROSE, BAKING POWDER***MAY CONTAIN***DISTRIBUTED BY: MARTHA WHITE FOODS, INC. P.O. BOX 751030, MEMPHIS, TN 38175***0 13300 54133 3","3101 501 BEST IF USED BY: 11 APR 14",".","4,986cs/12/6oz pouches","The states of Alabama and North Carolina through independent testing notified JM Smucker that aflatoxin levels exceeded FDA specification (<20 ppb). Levels tested ranged from 30 ppb to 207 ppb.",9/23/2013,"09/23/2013",11/13/2013,"11/13/2013"
"Food",66370,"Ongoing","J M Smucker Co","Orrville","OH","US","Voluntary: Firm Initiated","Letter","Product was shipped to the following states: AL, AR, AZ, CA, CO, FL, GA, HI, IL, IN, KS, KY, LA, MD, ME, MO, MS, NC, NE, NM, NY, NV, OH, OK, PA, SC, TN, TX, UT, VA, WA, WI and WY.","F-0108-2014","Class II","Martha White COTTON COUNTRY CORNBREAD BUTTERMILK CORNBREAD MIX NET WT 6 OZ (170g) Laminated Pouch Mfg Code 3106 501 BEST IF USED BY: 16 APR 14 & Mfg Code 3107 501 BEST IF USED BY: 17 APR 14 Product labeled in part, SINGREDIENTS: ENRICHED DEGERMINATED WHITE CORN MEAL, AND ENRICHED BLEACHED FLOUR***PARTIALLY DEHYDROGENATED SOYBEAN OIL, DEXTROSE, BAKING POWDER***MAY CONTAIN***DISTRIBUTED BY: MARTHA WHITE FOODS, INC. P.O. BOX 751030, MEMPHIS, TN 38175***0 13300 53101 3","3106 501 BEST IF USED BY: 16 APR 14 & 3107 501 BEST IF USED BY: 17 APR 14 ",".","12,196 cs/12/6oz pouches","The states of Alabama and North Carolina through independent testing notified JM Smucker that aflatoxin levels exceeded FDA specification (<20 ppb). Levels tested ranged from 30 ppb to 207 ppb.",9/23/2013,"09/23/2013",11/13/2013,"11/13/2013"
"Food",66370,"Ongoing","J M Smucker Co","Orrville","OH","US","Voluntary: Firm Initiated","Letter","Product was shipped to the following states: AL, AR, AZ, CA, CO, FL, GA, HI, IL, IN, KS, KY, LA, MD, ME, MO, MS, NC, NE, NM, NY, NV, OH, OK, PA, SC, TN, TX, UT, VA, WA, WI and WY.","F-0109-2014","Class II","Martha White SELF-RISING BUTTERMILK CORN MEAL MIX White-Enriched Hot Rize NET WT 32 OZ (2 LB) 907g Paper Bag Mfg Code 3151 511 BEST IF USED BY: 31 JAN 14 Product labeled in part, INGREDIENTS: ENRICHED WHITE CORN MEAL, WHEAT FLOUR AND DEGERMINATED WHITE CORN MEAL***BAKING POWDER***BUTTERMILK; SALT.***CONTAINS: MILK AND WHEAT INGREDIENTS***DISTRIBUTED BY: MARTHA WHITE FOODS, INC. P.O. BOX 751030, MEMPHIS, TN 38175***0 13300 18301 4","3151 511 BEST IF USED BY: 31 JAN 14 ",".","1,692 cs/12/2lb bags","The states of Alabama and North Carolina through independent testing notified JM Smucker that aflatoxin levels exceeded FDA specification (<20 ppb). Levels tested ranged from 30 ppb to 207 ppb.",9/23/2013,"09/23/2013",11/13/2013,"11/13/2013"
"Food",66370,"Ongoing","J M Smucker Co","Orrville","OH","US","Voluntary: Firm Initiated","Letter","Product was shipped to the following states: AL, AR, AZ, CA, CO, FL, GA, HI, IL, IN, KS, KY, LA, MD, ME, MO, MS, NC, NE, NM, NY, NV, OH, OK, PA, SC, TN, TX, UT, VA, WA, WI and WY.","F-0112-2014","Class II","Martha White Corn Meal Plain, White, Enriched NET WT 32 OZ (2 LB) 907g Paper Bag Mfg Code 3193 511 BEST IF USED BY: 12-Mar-14 Product labeled in part, INGREDIENTS: WHITE CORN MEAL, NIACIN, IRON, THIAMIN MONONITRATE, RIBOFLAVIN, FOLIC ACID*** MAY CONTAIN MILK AND WHEAT INGREDIENTS ***DISTRIBUTED BY: MARTHA WHITE FOODS, INC. P.O. BOX 751030, MEMPHIS, TN 38175***0 13300 13501 3","3193 511 BEST IF USED BY: 12-Mar-14 ",".","798 cases, 12 units per case","The states of Alabama and North Carolina through independent testing notified JM Smucker that aflatoxin levels exceeded FDA specification (<20 ppb). Levels tested ranged from 30 ppb to 207 ppb.",9/23/2013,"09/23/2013",11/13/2013,"11/13/2013"
"Food",66370,"Ongoing","J M Smucker Co","Orrville","OH","US","Voluntary: Firm Initiated","Letter","Product was shipped to the following states: AL, AR, AZ, CA, CO, FL, GA, HI, IL, IN, KS, KY, LA, MD, ME, MO, MS, NC, NE, NM, NY, NV, OH, OK, PA, SC, TN, TX, UT, VA, WA, WI and WY.","F-0107-2014","Class II","Martha White Buttermilk Cornbread & Muffin Mix NET WT 6 OZ (170g) Laminated Pouch Mfg Code 3105 501 BEST IF USED BY: 15 APR 14 Product labeled in part INGREDIENTS: ENRICHED DEGERMINATED WHITE CORN MEAL, WHEAT FLOUR*** PARTIALLY DEHYDROGENATED SOYBEAN OIL, DEXTROSE, BAKING POWDER***MAY CONTAIN***DISTRIBUTED BY: MARTHA WHITE FOODS, INC. P.O. BOX 751030, MEMPHIS, TN 38175***0 13300 51701 7","3105 501 BEST IF USED BY: 15 APR 14",".","10,906 cs/12/6 oz pouches","The states of Alabama and North Carolina through independent testing notified JM Smucker that aflatoxin levels exceeded FDA specification (<20 ppb). Levels tested ranged from 30 ppb to 207 ppb.",9/23/2013,"09/23/2013",11/13/2013,"11/13/2013"
"Food",66370,"Ongoing","J M Smucker Co","Orrville","OH","US","Voluntary: Firm Initiated","Letter","Product was shipped to the following states: AL, AR, AZ, CA, CO, FL, GA, HI, IL, IN, KS, KY, LA, MD, ME, MO, MS, NC, NE, NM, NY, NV, OH, OK, PA, SC, TN, TX, UT, VA, WA, WI and WY.","F-0104-2014","Class II","Jim Dandy Enriched Quick Grits, 1lb paper box, Labeled in part INGREDIENTS: WHITE CORN GRITS***NACIN, THIAMIN, MONONITRATE, RIBOFLAVIN, FOLIC ACID. DISTRIBUTED BY: MARTHA WHITE FOODS, INC., P. O. BOX 751030 MEMPHIS, TN 38175***0 13300 12107 8***3143 511 BEST IF USED BY: 23-JAN-14***","3143 511 BEST IF USED BY: 23-JAN-14",".","1270 cs/24/16 oz boxes","The states of Alabama and North Carolina through independent testing notified JM Smucker that aflatoxin levels exceeded FDA specification (<20 ppb). Levels tested ranged from 30 ppb to 207 ppb.",9/23/2013,"09/23/2013",11/13/2013,"11/13/2013"
"Food",66370,"Ongoing","J M Smucker Co","Orrville","OH","US","Voluntary: Firm Initiated","Letter","Product was shipped to the following states: AL, AR, AZ, CA, CO, FL, GA, HI, IL, IN, KS, KY, LA, MD, ME, MO, MS, NC, NE, NM, NY, NV, OH, OK, PA, SC, TN, TX, UT, VA, WA, WI and WY.","F-0113-2014","Class II","White Lily Corn Meal Self-Rising, White, Enriched NET WT 5 lb (2.26kg) Paper Bag Mfg Code 3193 511 BEST IF USED BY: 12-Mar-14 Product labeled in part, INGREDIENTS: ENRICHED WHITE CORN MEAL, WHEAT FLOUR AND DEGERMINATED WHITE CORN MEAL***BAKING POWDER***SALT***CONTAINS: WHEAT INGREDIENTS MAY CONTAIN MILK INGREDIENTS***DISTRIBUTED BY: THE WHITE LILY FOODS COMPANY 4740 BURBANK ROAD, MEMPHIS, TN 38118***0 32500 02381 4","3193 511 BEST IF USED BY: 12-Mar-14 ",".","5888 cases, 8 units per case","The states of Alabama and North Carolina through independent testing notified JM Smucker that aflatoxin levels exceeded FDA specification (<20 ppb). Levels tested ranged from 30 ppb to 207 ppb.",9/23/2013,"09/23/2013",11/13/2013,"11/13/2013"
"Food",66370,"Ongoing","J M Smucker Co","Orrville","OH","US","Voluntary: Firm Initiated","Letter","Product was shipped to the following states: AL, AR, AZ, CA, CO, FL, GA, HI, IL, IN, KS, KY, LA, MD, ME, MO, MS, NC, NE, NM, NY, NV, OH, OK, PA, SC, TN, TX, UT, VA, WA, WI and WY.","F-0105-2014","Class II","Martha White SELF-RISING Corn Meal Bolted White Enriched Hot Rize Net Wt 5 lb (2.26 kg) Paper bag, Mfg Code 3127 511 BEST IF USED BY: 7-Jan-14, Product labeled in part, INGREDIENTS: ENRICHED BOLTED WHITE CORN MEAL***BAKING POWDER***SALT***DISTRIBUTED BY: MARTHA WHITE FOODS, INC. P.O. BOX 751030, MEMPHIS, TN 38175***013300 18701 2","3127 511 BEST IF USED BY: 7-Jan-14",".","1,678 cs/8/5 lb bags","The states of Alabama and North Carolina through independent testing notified JM Smucker that aflatoxin levels exceeded FDA specification (<20 ppb). Levels tested ranged from 30 ppb to 207 ppb.",9/23/2013,"09/23/2013",11/13/2013,"11/13/2013"
"Food",66370,"Ongoing","J M Smucker Co","Orrville","OH","US","Voluntary: Firm Initiated","Letter","Product was shipped to the following states: AL, AR, AZ, CA, CO, FL, GA, HI, IL, IN, KS, KY, LA, MD, ME, MO, MS, NC, NE, NM, NY, NV, OH, OK, PA, SC, TN, TX, UT, VA, WA, WI and WY.","F-0114-2014","Class II","Martha White Cotton Country Cornbread, NET WT 6 OZ (170g) Paper Bag Mfg Code 3107 501 BEST IF USED BY: 17-Apr-14 Product labeled in part, INGREDIENTS: ENRICHED DEGERMINATED WHITE CORN MEAL, ENRICHED BLEACHED FLOUR***PARTIALLY HYDROGENATED SOYBEAN OIL, DEXTROSE, BAKING POWDER*** BUTTERMILK***SALT, SUGAR, SOY LECITHIN, GUAR GUM, NONFAT MILK, MALTODEXTRIN, CELLULOSE GUM, CORN STARCH.*** CONTAINS MILK, SOYBEAN AND WHEAT INGREDIENTS, MAY CONTAIN ALMOND, BRAZIL NUT, CASHEW, EGG, HAZELNUT, MACADAMIA NUT, PECAN, PINE NUT, PISTACHIO NUT AND WALNUT INGREDIENTS. ***DISTRIBUTED BY: MARTHA WHITE FOODS, INC. P.O. BOX 751030, MEMPHIS, TN 38175***0 13300 53101 3","3107 501 BEST IF USED BY: 17-Apr-14",".","3198","The states of Alabama and North Carolina through independent testing notified JM Smucker that aflatoxin levels exceeded FDA specification (<20 ppb). Levels tested ranged from 30 ppb to 207 ppb.",9/23/2013,"09/23/2013",11/13/2013,"11/13/2013"
"Food",66370,"Ongoing","J M Smucker Co","Orrville","OH","US","Voluntary: Firm Initiated","Letter","Product was shipped to the following states: AL, AR, AZ, CA, CO, FL, GA, HI, IL, IN, KS, KY, LA, MD, ME, MO, MS, NC, NE, NM, NY, NV, OH, OK, PA, SC, TN, TX, UT, VA, WA, WI and WY.","F-0110-2014","Class II","WHITE LILY ENRICHED WHITE Cornmeal MIX SELF-RISING NET WT 32 OZ (2 LB) 907g Paper Bag Mfg Code 3135 511 BEST IF USED BY: 15-JAN-14 Product labeled in part, INGREDIENTS: ENRICHED WHITE CORN MEAL, WHEAT FLOUR AND DEGERMINATED WHITE CORN MEAL***BAKING POWDER***SALT***CONTAINS: WHEAT INGREDIENTS MAY CONTAIN MILK INGREDIENTS***DISTRIBUTED BY: THE WHITE LILY FOODS COMPANY 4740 BURBANK ROAD, MEMPHIS, TN 38118***0 13300 02281 7","3135 511 BEST IF USED BY: 15-JAN-14 ",".","1,083cs/12/2 lb bags","The states of Alabama and North Carolina through independent testing notified JM Smucker that aflatoxin levels exceeded FDA specification (<20 ppb). Levels tested ranged from 30 ppb to 207 ppb.",9/23/2013,"09/23/2013",11/13/2013,"11/13/2013"
"Drugs",66371,"Ongoing","Hill Dermaceuticals, Inc.","Sanford","FL","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Nationwide and Puerto Rico.","D-007-2014","Class III","Derma-Smoothe/FS (fluocinolone acetonide) 0.01% Topical Oil (Scalp Oil), 118.28 mL (4 Fl. oz.) bottle, Rx only, Manufactured and Distributed by: Hill Dermaceuticals, Inc., Sanford, Florida 32773, NDC 28105-149-04.","K111090 exp.10/13, K111122 exp10/13, K111140 exp.10/13, K111150 exp.10/13, 111180 exp.11/13, L111190 exp11/13, M111250 exp.12/13, M111270 exp.12/13, and M111292 exp.12/13",,,"Subpotent Drug: The active ingredient, fluocinolone acetonide, was found to be subpotent during the firm's routine testing.",9/8/2013,"09/08/2013",11/27/2013,"11/27/2013"
"Drugs",66371,"Ongoing","Hill Dermaceuticals, Inc.","Sanford","FL","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Nationwide and Puerto Rico.","D-008-2014","Class III","Derma-Smoothe/FS (fluocinolone acetonide) 0.01% Topical Oil (Body Oil), 118.28 mL (4 fl. oz.) bottle, Rx only, Manufactured and Distributed by: Hill Dermaceuticals, Inc., Sanford, Florida 32773, NDC 28105-150-04.","K111100 exp.10/13, K111110 exp.10/13, M111240 exp.12/13, and A120012 exp.01/14 ",,,"Subpotent Drug: The active ingredient, fluocinolone acetonide, was found to be subpotent during the firm's routine testing.",9/8/2013,"09/08/2013",11/27/2013,"11/27/2013"
"Drugs",66373,"Ongoing","Sandoz Incorporated","Broomfield","CO","US","Voluntary: Firm Initiated","Letter","Nationwide","D-66373-001","Class III","Hydroxychloroquine Sulfate Tablets, USP, 200 mg, Rx Only, 100 Tablets per bottle, Sandoz Inc., Princeton NJ, 08540, NDC 0781-1407-01.","Lot #: BU3417, Exp 06/2014 ",".","25,830 bottles ","Failed Tablet/Capsule Specifications: Sandoz is recalling one lot of Hydroxychloroquine Sulfate Tablets, USP, 200mg, due to illegibility of the logo on some tablets.",9/25/2013,"09/25/2013",10/16/2013,"10/16/2013"
"Devices",66374,"Ongoing","Bard Peripheral Vascular Inc","Tempe","AZ","US","Voluntary: Firm Initiated","Letter","US Nationwide Distribution.","Z-0007-2014","Class I","Bard LifeStent Solo Vascular Stent, Item Numbers: EX062001CL, EX072001CL, EX062003CL, EX072003CL. The LifeStent Solo Vascular Stent System is intended to improve luminal diameter in the treatment of symptomatic de-novo or restenotic lesions up to 240 mm in length in the native superficial femoral artery (SFA) and in the proximal popliteal artery with reference vessel diameters ranging from 4.0 6.5 mm.","Product Code:EX062001CL Lot Numbers: ANVG3284, ANVH2474, ANVJ1379, ANVJ2590, ANVK3364, ANVL2910, ANVG3862, ANVH2475, ANVJ2089, ANVK3149, ANVK3707, ANVH0592, ANVH3715, ANVK3150, ANVL2902. Product Code: EX062003CL Lot Numbers: ANVG3285 ANVH1962 ANVJ1385 ANVK3655 ANVL2915 ANWA1414 ANVG3286 ANVH2125 ANVJ1799 ANVL0001 ANWA0307 ANWA1415 ANVG3287 ANVH2126 ANVJ1800 ANVL0002 ANWA0308 ANWA1416 ANVG3882 ANVH2127 ANVJ1801 ANVL0169 ANWA0458 ANWA1419 ANVG3883 ANVH2185 ANVJ1802 ANVL0170 ANWA0459 ANWA3834 ANVG3884 ANVH2186 ANVJ1890 ANVL0364 ANWA0493 ANWA3855 ANVG3885 ANVH2187 ANVJ1891 ANVL0526 ANWA0494 ANWB0137 ANVH0325 ANVH2392 ANVJ1892 ANVL0527 ANWA0495 ANWB0139 ANVH0326 ANVH2393 ANVJ1893 ANVL0528 ANWA0698 ANWB1630 ANVH0327 ANVH3089 ANVJ2090 ANVL0811 ANWA0699 ANWB1631 ANVH0328 ANVH3278 ANVJ2091 ANVL0812 ANWA0701 ANWB1632 ANVH0329 ANVH3279 ANVJ2337 ANVL0813 ANWA0820 ANWD3081 ANVH0593 ANVH3434 ANVJ2591 ANVL0814 ANWA0821 ANWE1362 ANVH0594 ANVH3435 ANVK0075 ANVL1027 ANWA0857 ANWE1365 ANVH0596 ANVH3451 ANVK0076 ANVL1028 ANWA0858 ANWE1366 ANVH0597 ANVH3452 ANVK0077 ANVL1029 ANWA0859 ANWE1368 ANVH0598 ANVH3453 ANVK0078 ANVL1219 ANWA0964 ANWE2371 ANVH0997 ANVH3454 ANVK0474 ANVL1220 ANWA0965 ANWE2864 ANVH0998 ANVH3716 ANVK0552 ANVL1221 ANWA0966 ANWE3415 ANVH0999 ANVH3717 ANVK0755 ANVL1391 ANWA0967 ANWE3416 ANVH1000 ANVH3718 ANVK0756 ANVL1392 ANWA1125 ANWE3550 ANVH1001 ANVI0132 ANVK0871 ANVL1393 ANWA1373 ANWE3551 ANVH1002 ANVI0134 ANVK0872 ANVL1394 ANWA1384 ANWE3552 ANVH1182 ANVI0135 ANVK1133 ANVL1604 ANWA1385 ANWE3685 ANVH1183 ANVI0136 ANVK1134 ANVL1605 ANWA1388 ANWE3686 ANVH1184 ANVI0311 ANVK1253 ANVL1608 ANWA1390 ANWE3982 ANVH1185 ANVI0808 ANVK1461 ANVL1609 ANWA1391 ANWE4134 ANVH1186 ANVI0967 ANVK1462 ANVL1762 ANWA1395 ANWE4135 ANVH1187 ANVI1251 ANVK1463 ANVL1763 ANWA1396 ANWE4136 ANVH1188 ANVI1252 ANVK1669 ANVL1764 ANWA1397 ANWF0178 ANVH1189 ANVI2510 ANVK1670 ANVL1765 ANWA1398 ANWF0179 ANVH1190 ANVI2511 ANVK1671 ANVL2346 ANWA1399 ANWF0180 ANVH1191 ANVI2513 ANVK1982 ANVL2347 ANWA1400 ANWF0370 ANVH1324 ANVI2514 ANVK1983 ANVL2687 AN",".","4112 units","Bard Peripheral Vascular is recalling specific lots of Bard Lifestent Solo Vascular Stent because they have determined a higher incidence rate of partial stent deployment associated with their use.",9/30/2013,"09/30/2013",10/16/2013,"10/16/2013"
"Food",66375,"Ongoing","Norpac Foods, Inc.","Stayton","OR","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Products distributed in Illinois, Missouri, and Nebraska.","F-0081-2014","Class I","Frozen Sliced Carrots, packaged in 2 lbs. bag, sold under Simplot Classic brand. The UPC is 0 71179 1846 3 1. The product is labeled in parts: ''***SIMPLOT CLASSIC***Sliced Carrots***NET WT 32 OZ. (2 LBS)***INGREDIENTS: CARROTS***KEEP FROZEN UNTIL READY TO USE. IF THAWED. DO NOT REFREEZE***Preparation Instructions***DISTRIBUTED BY: JR SIMPLOT COMPANY***BOISE, IDAHO 83707***PRODUCT OF U.S.A***''.","BEST BY SEP 2015/ 5M3 13X2L4 HH:MM. Product has Best By SEPTEMBER 2015. The code 5M3 13X2L4 HH:MM meant the product was repacked into Poly Bags on September 13, 2013, 07:47 am to 14:32 pm at NORPAC Foods, Inc., Quincy Foods, LLC Plant 2, 222 Columbia Way, PO Box 127, Quincy, WA 98848. ",".","40 cases/ 12 packages/2 lbs.","Green shelled soybeans (Edamame) are potentially mixed in with sliced carrots.",9/20/2013,"09/20/2013",10/30/2013,"10/30/2013"
"Biologics",66376,"Terminated","Mississippi Valley Reg Bld Ctr","Davenport","IA","US","Voluntary: Firm Initiated","Telephone","Iowa","B-0073-14","Class III","Red Blood Cells Leukocytes Reduced","W333613071313; ",".","1","Blood product, with insufficient red cell preservative solution added, was distributed.",8/23/2013,"08/23/2013",12/11/2013,"12/11/2013"
"Biologics",66378,"Terminated","American National Red Cross (The)","Salt Lake City","UT","US","Voluntary: Firm Initiated","Telephone","Idaho, Utah","B-0081-14","Class II","Red Blood Cells Leukocytes Reduced","W20201303552300",".","1 unit","Blood products, collected from a donor for whom donor suitability was not adequately determined, were distributed.",5/31/2013,"05/31/2013",12/11/2013,"12/11/2013"
"Biologics",66378,"Terminated","American National Red Cross (The)","Salt Lake City","UT","US","Voluntary: Firm Initiated","Telephone","Idaho, Utah","B-0082-14","Class II","Plasma Frozen within 24 hours (FP24)","W20201303552300",".","1 unit","Blood products, collected from a donor for whom donor suitability was not adequately determined, were distributed.",5/31/2013,"05/31/2013",12/11/2013,"12/11/2013"
"Devices",66379,"Ongoing","Pentax Medical Company","Montvale","NJ","US","Voluntary: Firm Initiated","Letter","Nationwide Distribution including Arizona, California, Florida, Idaho, Indiana, Kansas, Maryland, Missouri, Missippi, North Carolina, New York, Pennsylvania, Virginia, Wisconsin and Wyoming.","Z-0084-2014","Class I","PENTAX Endoscopic Accessories. OF-B194. Made in Japan. PENTAX Upper/Lower G.I. Endoscopes are provided with Air/Water Valve. As an alternative, the optionally available Gas/Water Valve may be used in place of the standard Air/Water Valve to deliver a non-explosive gas for insufflation.","Model OF-B194",,"76 units","PENTAX Medical has become aware of a product issue associated with the OF-B194 Gas/Water Feeding Valve. A manufacturing defect may cause improper stoppage of CO2 gas during an endoscopic procedure with the potential for serious hazard to and/or user.",9/16/2013,"09/16/2013",11/6/2013,"11/06/2013"
"Devices",66381,"Ongoing","GE Healthcare, LLC","Waukesha","WI","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution-USA (nationwide) including DC and Puerto Rico except DE, ME, NM, RI, and VT, and the countries of UNITED ARAB EMIRATES, JAPAN, KAZAKHSTAN, KENYA, REPUBLIC OF KOREA, KUWAIT, LATVIA, LEBANON, LIBYAN ARAB JAMAHIRIYA, LITHUANIA, MACEDONIA , MALAYSIA, MEXICO, MOLDOVA, MOROCCO, NAMIBIA, NETHERLANDS, NEW ZEALAND, NORWAY, PAKISTAN, PANAMA, PARAGUAY, PERU, PHILIPPINES, POLAND, PORTUGAL, QATAR, ROMANIA, RUSSIAN FEDERATION,SAUDI ARABIA, SERBIA, SINGAPORE, SLOVAKIA, SLOVENIA, SOUTH AFRICA, SPAIN, SWEDEN, SWITZERLAND, SYRIAN ARAB REPUBLIC, TAIWAN, TANZANIA, THAILAND, TURKEY, UNITED KINGDOM, VIETNAM, URUGUAY, and VENEZUELA.","Z-0009-2014","Class I","GE Healthcare, Aisys, Amingo, Avance, and Avance CS2. Intended for volume or pressure control ventilation.","Mfg Lot or Serial # ANBR01060 ANAQ01557 ANBQ01421 ANBQ01418 ANBQ01419 ANBQ01420 ANBR01342 ANBR00292 ANBR00289 ANBR00293 ANBR00290 ANBR00291 ANBR00294 ANBR00295 ANBQ01522 ANBQ01520 ANBQ01524 ANBQ01521 ANBQ01523 ANBQ02209 ANBQ02212 ANBQ02213 ANBQ02210 ANBQ02211 ANBS00535 ANBR01079 ANBR01078 ANBR01080 ANAQ00842 ANBR01053 ANBR01054 ANBQ01015 ANBQ01965 ANBQ01480 ANBQ01966 ANBQ01484 ANBS00304 ANBS00305 ANAR00675 ANAR05794 ANAR05793 ANBQ01751 ANBR00248 ANAS00596 ANAS00593 ANBQ01055 ANBQ01052 ANBQ01056 ANBQ01051 ANBQ01053 ANBQ01054 ANAQ01176 ANAQ01177 ANAR05091 ANAR05174 ANBQ00785 ANBQ00786 ANBR00256 ANBQ01664 ANBQ01259 ANBQ01258 APKS00537 APKS00538 ANAQ01781 ANBQ01041 ANBQ00109 ANBR02305 ANBR02304 ANBR02306 ANBR02307 ANAQ01376 ANAQ01377 ANAS00332 ANAS00331 ANAS01022 ANAS01024 ANAS01023 ANAS01019 ANAS01025 ANAS01016 ANAS01017 ANAS01020 ANAS01018 ANAS01021 ANAS01017 ANAS01022 ANAS01016 ANAS01018 ANAS01024 ANAS01019 ANAS01020 ANAS01021 ANAS01023 ANAS01025 ANBR00581 ANBR00580 ANAS00264 ANAP00948 ANAS00448 ANAR00952 ANAR00953 ANAR00955 ANAR00951 ANAR00954 ANAQ00470 ANAQ00510 ANAQ00511 ANAS00579 ANAQ00461 ANAQ00465 ANAQ00466 ANAQ00464 ANAQ00462 ANAQ00463 ANAQ00512 ANAQ00830 ANAQ00829 ANAQ00833 ANAQ00831 ANAQ00834 ANAQ00835 ANAQ00832 ANAQ01594 ANAR00232 ANAR00257 ANAR00254 ANAR00553 ANAR00558 ANAR05477 ANAR05476 ANAR05479 ANAR05478 ANAR05480 ANAR05481 ANAS00211 ANAS00628 ANBR00526 ANBR00609 ANBR00607 ANBR00604 ANBR00605 ANBR00608 ANBR00610 ANBR00606 ANBR01525 ANBR00666 APKS00356 ANAR00332 ANAR00331 ANBR00147 ANBR00142 ANBR00144 ANBR00145 ANBR00148 ANBR00150 ANBR00143 ANBR00149 ANBR00146 ANAS00569 ANAR00549 ANAR05005 ANAR05052 ANAR05053 ANAR05009 ANAR05054 ANAR05008 ANAR05004 ANAR05002 ANAR05006 ANAR05007 ANAR05003 ANBQ01248 ANBQ01247 ANBQ01245 ANBQ01244 ANBQ01246 ANBQ01412 ANBQ01409 ANBQ01408 ANBQ01410 ANBQ01411 ANBQ01413 ANAS00572 ANAS00574 ANAS00571 ANAS00575 ANAS00576 ANAQ01188 ANAR05265 ANAR05264 ANAR05610 ANAR05611 ANAS00204 ANAS00202 ANAS00203 ANAS00697 ANAS00698 ANAS00699 ANBR01689 ANBR01690 ANBR01629 ANAR05538 ANAR0"," ANAS00173 ANAS00174 ANAS00169 ANBR01830 ANBR01831 ANAR05088 ANBQ01752 ANBQ00161 ANBQ01925 APKS00337 ANAR00556 ANAR05136 ANAR05138 ANAQ00812 ANAQ01423 ANAQ01422 ANAQ00965 ANAQ01093 ANAQ01094 ANAQ01092 ANAQ01091 ANAQ01095 ANAQ00965 ANAQ01095 ANAQ01092 ANAQ01094 ANAQ01093 ANAQ01091 ANAP00776 ANAR00760 ANAR00761 ANAR05531 ANAR00416 ANAR05001 APWR02MAEP APWR01MAEP APWR05MAEP APWR03MAEP APWR04MAEP APWR09MEAP APWR08MEAP APWR10MAEP APWR12MAEP APWR07MEAP APWR11MAEP ANBQ00808 ANBQ00807 ANBQ00805 ANBQ00806 ANBR00331 ANBR00330 APKR00136 APKR00135 APKR00132 APKR00131 ANAR05056 ANAR05059 ANAR05055 ANAR05057 ANAR05058 ANAR05704 ANAR05705 ANAR05082 ANAR05129 ANAR05125 ANAR05127 ANAR05126 ANAR05128 ANAR05124 ANAR05512 ANAR05511 APKR00139 APKR00137 APKR00140 APKR00141 APKR00138 APKS00206 ANAR05310 ANAR05988 ANAR05987 ANAR05989 ANAR05990 ANAR05991 ANAR05985 ANAR05986 ANBQ01680 ANBP01613 ANBQ00775 ANBP01615 ANBS00267 ANAQ00579 ANAQ00563 ANAQ00686 ANAQ00557 ANAQ01057 ANAQ00918 ANAQ00574 ANAQ00580 ANAQ00561 ANAQ00578 ANAQ00575 ANAQ01061 ANAQ01063 ANAQ01064 ANAQ01062 ANAQ01334 ANAQ01333 ANAQ01335 ANAQ01329 ANAQ01331 ANAQ01332 ANAQ01330 ANAS00222 ANAS00223 ANBQ01117 ANBQ01113 ANBQ01115 ANBQ01114 ANBQ01116 ANBQ01178 ANBQ01172 ANBQ01173 ANBQ01180 ANBQ01175 ANBQ01177 ANBQ01174 ANBQ01179 ANBQ01176 ANBQ01713 ANBQ01715 ANBQ01714 ANBQ01716 ANBQ01711 ANBQ01712 ANBR02420 ANBQ01471 ANBQ01575 ANBQ01472 ANBQ01474 ANBQ01576 ANBQ01574 ANBQ01583 ANBQ01584 ANBQ01587 ANBQ01582 ANBQ01585 ANBS00547 ANBS00551 ANBS00858 ANBS00607 ANBS00856 ANBS00860 ANBS00862 ANBS00611 ANBS00613 ANBS00863 ANBS00549 ANBS00609 ANBS00550 ANBS00614 ANBS00857 ANBS00859 ANBS00861 APKS00170 APKS00174 APKS00181 APKS00176 APKS00182 APKS00169 APKS00175 APKS00179 APKS00173 APKS00178 APKS00180 APKS00166 APKS00171 APKS00177 APKS00167 APKS00168 APKS00172 APKS00159 APKS00160 APKS00162 APKS00164 APKS00161 APKS00163 APKS00165 APKS00275 APKS00276 APKS00274 APKS00277 APKS00232 ANBQ01494 ANBQ01493 ANBQ01500 ANBQ01492 ANBQ01495 ANBQ01498 ANBQ01499 ANBQ01503 ANBQ01490 ANBQ01497 ANBQ01491 ANB","10,263 (3,194 US, 7,069 OUS)","GE Healthcare has recently become aware of a potential safety issue involving the Avance, Avance CS2, and Aisys anesthesia devices. While operating in Pressure Control Ventilation Volume Guarantee (PCV-VG) mode, the affected products may produce an over delivery tidal volume when given a unique sequence of user inputs and a collapsed bellows (partially filled circuit). Exposure to excessive tidal volumes while pressure limits are maintained can result in pulmonary volutrauma and/or an increased pulmonary vascular resistance that can negatively affect cardiac filling pressure and/or stroke volume.",9/16/2013,"09/16/2013",10/23/2013,"10/23/2013"
"Devices",66382,"Ongoing","Beckman Coulter Inc.","Brea","CA","US","Voluntary: Firm Initiated","Letter","Worldwide distribution: US (nationwide) including Puerto Rico, and countries of: Australia, Belgium, Canada, China, Croatia, Czech Republic, France, Germany, Hong Kong, India, Ireland, Italy, Japan, Macao, Netherlands, New Zealand, Panama, Poland, Portugal Qatar, Russian Federation, Spain, Sweden, Switzerland, Taiwan, Thailand, Trindad and Tobago, Turkey, United Arab Emirates, and United Kingdom. .","Z-0147-2014","Class II","UniCel DxH 800 and DxH 600 Coulter Cellular Analysis Systems The UniCel DxH 800/DxH 600 analyzers are quantitative, multiparameter, automated hematology analyzers for in vitro diagnostic use in screening patient populations found in clinical laboratories. The DxH 800 is available as an analyzer for use on a tabletop or with a floor stand. The DxH 600 is available as an analyzer for use on a tabletop only.","Part Numbers: 629029 for DxH 800 and B23858 for DxH 600. Serial Numbers: AS49437 AV11229 AV23436 AV28032 AT05062 AU32435 AT27373 AT09132 AV06132 AV06143 AT21266 AT21268 AT23307 AS46410 AS46411 AU48003 AV05097 AT27346 AT40554 AU23277 AV05082 AV05092 AV11205 AT06076 AT09112 AT09114 AT16214 AT18235 AV11214 AV11217 AN30069 AS07008 AT09116 AS40361 AU05048 AU05054 AT48658 AS49426 AS49429 AV01023 AV01025 AM48043 AV06003 AT40542 AS15064 AT30380 AV01015 AS12050 AV06004 AV06151 AS12051 AS12052 AT01004 AU25303 AT36497 AT36499 AT36509 AV06127 AV06130 AV11231 AV14273 AV14275 AV27546 AV06141 AV01009 AV05104 AV09187 AV09192 AV09179 AU42632 AV06152 AV11238 AV14278 AV14283 AV28554 AV28559 AV23449 AV18362 AV09180 AV18364 AV24456 AV22393 AV11234 AV02072 AV05098 AV09184 AV02046 AV09191 AV09196 AV09197 AV24452 AT18242 AV09182 AV02051 AV02068 AV02076 AV06139 AV11236 AV12241 AV14287 AV28031 AV06147 AV11216 AV24490 AV26492 AV26498 AV26499 AS46412 AV12265 AV14266 AV05093 AV01032 AV14288 AV18373 AV26506 AV27512 AV02042 AU06070 AV06150 AV23424 AV26491 AV26495 AV26496 AV26500 AV26501 AV26503 AV26504 AV26505 AV27514 AV02064 AV18371 AV18375 AV01029 AV01031 AS43391 AS43392 AV01006 AV11232 AV23419 AV23423 AV28026 AV16315 AV16326 AN10031 AV01002 AV14294 AV18359 AV18365 AV27541 AV12260 AV05117 AV05120 AV27533 AV06154 AV06157 AV22386 AV28028 AV28595 AT44622 AV11202 AV27542 AV28564 AV22388 AT24332 AT27337 AV24467 AT42590 AV02044 AV02052 AV05095 AV05107 AV05109 AT27347 AN10025 AN20049 AS40359 AV12245 AV12247 AS24192 AV16337 AV16339 AU47779 AV14271 AN30064 AN30070 AV24457 AV24458 AV27537 AT02042 AU40574 AV14295 AT48660 AV23422 AT27343 AV28561 AN07022 AN10027 AT27345 AV02061 AT23288 AN42123 AT21265 AV27544 AV02070 AT18248 AV16336 AV06148 AV11221 AV11227 AV01008 AU05052 AV18358 AV18369 AV24465 AV24466 AV05096 AV01035 AV01038 AT23274 AV05099 AV18349 AV18366 AV28033 AV23439 AV24455 AV28029 AV28030 AU02003 AV05085 AV06140 AV22407 AV23430 AV27524 AV27528 AV28580 AV09172 AS27199 AS27204 AS27221 AS27222 AS30231 AS30232 AS30238 AS30242 AS30243 AS32248 AS32",".","1,025 units","Beckman Coulter is initiating a recall for UniCel DxH 800 Coulter Cellular Analysis System (PN 629029) and UniCel DxH 600 Coulter Cellular Analysis System (PN B23858) because the company's internal investigation indicates that specific lots of check valves used in several locations within the DxH 800 and DxH 600 systems may fail. A failure may result in an air or liquid leak at the VCS Waste Chamber or Probe Waste Chamber.",9/24/2013,"09/24/2013",11/13/2013,"11/13/2013"
"Devices",66383,"Ongoing","Beckman Coulter Inc.","Brea","CA","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution - Nationwide Distribution and the country of Canada..","Z-0113-2014","Class II","COULTER LH 750 and LH 780 Analyzers. The COULTER LH 750 Hematology Analyzer is a quantitative, automated hematology analyzer and leukocyte differential counter For In Vitro Diagnostic Use in clinical laboratories. The COULTER LH 750 Hematology Analyzer provides automated Reticulocyte analysis and enumeration of nucleated red blood cells (NRBCs) as well as an automated method for enumeration of RBCs and WBCs in body fluids. The COULTER LH 780 Hematology Analyzer is a quantitative, automated hematology analyzer and leukocyte differential counter For In Vitro Diagnostic Use in clinical laboratories. The COULTER LH 780 Hematology Analyzer also provides automated Reticulocyte analysis and enumeration of nucleated red blood cells (NRBCs) as well as an automated method for enumeration of RBCs and WBCs in body fluids.","Part Numbers: 6605362 for the LH 750 and 723585 for the LH 780. Serial Numbers: AJ08102 AK49053 AM09075 AM10078 AG05059 AK41634 AT02015 AL41189 AJ06078 AF22202 AK34502 AL02001 AS49367 AM10085 AJ10154 AM40321 AS41335 AK32475 AS30241 AU28106 AK36538 AL18073 AL18077 AL37150 AH15237 AL09039 AL09042 AK02032 AJ31547 AJ24410 AM24242 AN13074 AN13075 AN13078 AT18112 AT18115 AG45676 AK46036 AG39545 AJ24402 AJ43796 AK49046 AM05019 AH21364 AH21367 AH21368 AH21369 AH21375 AH23391 AT26118 AN11064 AM02006 AE44164 AJ05072 AJ04046 AJ05065 AJ05073 AN19134 AG17221 AH43790 AM20190 AL39172 AT46205 AH43787 AJ04043 AM17139 AM18149 AS35295 AL52333 AF03026 AL50300 AK49040 AL47248 AK11167 AM35324 AS35299 AF44462 AH47839 AJ28468 AG46712 AK46033 AT36156 AT07053 AH38689 AH43782 AG46711 AN19127 AF02009 AJ06081 AJ07089 AE46202 AF06058 AS49369 AG31388 AG48745 AJ08113 AM23218 AG18236 AG21268 AE45183 AL12053 AU10036 AJ23389 AN04028 AN06034 AM40314 AL50405 AK24368 AL52467 AL51444 AG30381 AN25186 AN25187 AM37348 AL46245 AL47251 AG36485 AH29512 AM44418 AM44421 AT02011 AL10069 AN26201 AM04046 AG12158 AV14043 AT38176 AL29255 AG05053 AJ07099 AK21317 AE36072 AS13058 AU51205 AV11032 AK19285 AN39332 AJ29494 AF33293 AN42337 AM35330 AS38206 AL47259 AL29118 AL29119 AM42341 AM22212 AM23230 AM24238 AJ34618 AS23110 AF42431 AF44470 AT35181 AN38312 AN38313 AH36641 AJ45827 AL11095 AJ24440 AL52320 AL52323 AM38275 AM42391 AM42393 RAU51073 AL43212 AG16203 AT49244 AS23098 AL41323 AE29052 AJ28477 AK22335 AL09035 AL49280 AM21202 AN39330 AN04026 AT49245 AJ42784 AM26261 AM26265 AG14178 AG46706 AM19168 AM38283 AN26202 AS36189 AM29276 AM18145 AL43218 AK21322 AG41591 AM33300 AL11093 AK20292 AS46266 AK48746 AS19124 AH11168 AJ33591 AS23097 AL50399 AT08065 AM16138 AM24177 AM29184 AM36269 AL50425 AK11185 AK11189 AJ41760 AN09048 AN13072 AL47268 AN25184 AJ40726 AJ48869 AN49177 AT07060 AS02013 AH15245 AL19085 AL39166 AL39173 AS38205 AH29492 AJ47001 AM38289 AN17106 AJ49883 AM18155 AM43398 AK34498 AK35514 AL37315 AL45366 AM32232 AL47272 AF49521 AJ50901 AG39549 AG40557 AG40559 AF42",,"1,697 units","Beckman Coulter internal investigation indicated that specific lots of check valves used in several locations within the LH 750 and LH 780 analyzers may fail. This failure may result in an air or liquid leak at the connection to the Vacuum Overflow Tank waste line or at the Backwash Tank drain line. Source of initial complaint: Customer laboratory in the United States.",9/24/2013,"09/24/2013",11/6/2013,"11/06/2013"
"Food",66384,"Ongoing","Pharmavite Corporation","Northridge","CA","US","Voluntary: Firm Initiated","Letter","US nationwide. No International.","F-0186-2014","Class II","Multi for Her 50+ (Full Strength Mini and Multi softgels) 24 units per master case. Product labeling reads in part:''NatureMade***DIETARY SUPPLEMENT 60 SOFTGELS***Distributed by: Nature Made Nutritional Products Mission Hills, CA 91346-9606, U.S.A 1-800-276-2878 www.NatureMade.com***''","All lots. UPC Code 2863 0-31604-02863-3. List # 2863. ",,"182,698 bottles","Pharmavite LLC is conducting a voluntary recall of all lots of its Nature Made Full Strength Mini Multivitamins (recently repackaged as ''Multi'' softgels, (Multi Complete, Multi for Her, Multi for Her 50+, Multi for Him, Multi Complete club size). because recent quality tests indicate that the Vitamins B1 and B12 are losing potency more rapidly than initially expected, and these products are not meeting label claims for these vitamins throughout their shelf life.",9/9/2013,"09/09/2013",11/27/2013,"11/27/2013"
"Food",66384,"Ongoing","Pharmavite Corporation","Northridge","CA","US","Voluntary: Firm Initiated","Letter","US nationwide. No International.","F-0184-2014","Class II","Multi Complete (Full Strength Mini and Multi Softgels), 60 Count Bottle. 24 units per master case.+++Multi Complete (club size) (Full Strength Mini and Multi Softgels), 180 Count Bottle. 20 units per master case. Product labeling reads in part:''NatureMade***DIETARY SUPPLEMENT 60 SOFTGELS***Distributed by: Nature Made Nutritional Products Mission Hills, CA 91346-9606, U.S.A 1-800-276-2878 www.NatureMade.com***''","All Lots. UPC Code 0-31604-02861-9, List # 2861. +++ All lots. UPC Code 2874 0-31604-02874-9. List # 2874.",,"275,342 bottles; 74,080 bottles(Club pack)","Pharmavite LLC is conducting a voluntary recall of all lots of its Nature Made Full Strength Mini Multivitamins (recently repackaged as ''Multi'' softgels, (Multi Complete, Multi for Her, Multi for Her 50+, Multi for Him, Multi Complete club size). because recent quality tests indicate that the Vitamins B1 and B12 are losing potency more rapidly than initially expected, and these products are not meeting label claims for these vitamins throughout their shelf life.",9/9/2013,"09/09/2013",11/27/2013,"11/27/2013"
"Food",66384,"Ongoing","Pharmavite Corporation","Northridge","CA","US","Voluntary: Firm Initiated","Letter","US nationwide. No International.","F-0185-2014","Class II","Multi for Her (Full Strength Mini and Multi Softgels), 60 Count Bottle. 24 units per master case. Product labeling reads in part:''NatureMade***DIETARY SUPPLEMENT 60 SOFTGELS***Distributed by: Nature Made Nutritional Products Mission Hills, CA 91346-9606, U.S.A 1-800-276-2878 www.NatureMade.com***''","All lots. UPC Code 2862 0-31604-02862-6. List # 2862.",,"311,456 bottles","Pharmavite LLC is conducting a voluntary recall of all lots of its Nature Made Full Strength Mini Multivitamins (recently repackaged as ''Multi'' softgels, (Multi Complete, Multi for Her, Multi for Her 50+, Multi for Him, Multi Complete club size). because recent quality tests indicate that the Vitamins B1 and B12 are losing potency more rapidly than initially expected, and these products are not meeting label claims for these vitamins throughout their shelf life.",9/9/2013,"09/09/2013",11/27/2013,"11/27/2013"
"Food",66384,"Ongoing","Pharmavite Corporation","Northridge","CA","US","Voluntary: Firm Initiated","Letter","US nationwide. No International.","F-0187-2014","Class II","Multi For Him (Full Strength Mini and Multi Softgels), 60 Count Bottle. 24 units per master case. Product labeling reads in part:''NatureMade***DIETARY SUPPLEMENT 60 SOFTGELS***Distributed by: Nature Made Nutritional Products Mission Hills, CA 91346-9606, U.S.A 1-800-276-2878 www.NatureMade.com***''","All lots. UPC Code 2864 0-31604-02864-0. List # 2864. ",,"130,280 bottles","Pharmavite LLC is conducting a voluntary recall of all lots of its Nature Made Full Strength Mini Multivitamins (recently repackaged as ''Multi'' softgels, (Multi Complete, Multi for Her, Multi for Her 50+, Multi for Him, Multi Complete club size). because recent quality tests indicate that the Vitamins B1 and B12 are losing potency more rapidly than initially expected, and these products are not meeting label claims for these vitamins throughout their shelf life.",9/9/2013,"09/09/2013",11/27/2013,"11/27/2013"
"Biologics",66385,"Terminated","Tri-counties Blood Bank","San Luis Obispo","CA","US","Voluntary: Firm Initiated","Telephone","California","B-0080-14","Class II","Platelets Pheresis Leukocytes Reduced","W1428130364404",".","1 unit","Blood product, which was not tested for platelet yield and pH, was distributed.",8/13/2013,"08/13/2013",12/11/2013,"12/11/2013"
"Biologics",66386,"Terminated","American National Red Cross (The)","Oakland","CA","US","Voluntary: Firm Initiated","FAX","MD","B-0116-14","Class II","Platelets Pheresis Leukocytes Reduced","W20841380012200",".","1 unit","Blood product, which did not meet the acceptable product specifications for release, was distributed.",8/16/2013,"08/16/2013",12/4/2013,"12/04/2013"
"Biologics",66387,"Terminated","BloodCenter of Wisconsin, Inc","Milwaukee","WI","US","Voluntary: Firm Initiated","Telephone","Wisconsin","B-0009-14","Class III","Red Blood Cells Leukocytes Reduced","W036313266011; W036313266096; ",".","2","Blood products, collected in expired collection bags, were distributed.",8/5/2013,"08/05/2013",12/11/2013,"12/11/2013"
"Biologics",66387,"Terminated","BloodCenter of Wisconsin, Inc","Milwaukee","WI","US","Voluntary: Firm Initiated","Telephone","Wisconsin","B-0010-14","Class III","Red Blood Cells","W036313266113; W036313266241; ",".","2","Blood products, collected in expired collection bags, were distributed.",8/5/2013,"08/05/2013",12/11/2013,"12/11/2013"
"Biologics",66388,"Terminated","Arup Laboratories, Inc.","Sandy","UT","US","Voluntary: Firm Initiated","E-Mail","Utah","B-0011-14","Class II","Platelets Pheresis Leukocytes Reduced","W158013801466; ",".","1","Blood product, collected without the performance of a WBC count during instrument re-validation, was distributed.",8/5/2013,"08/05/2013",12/11/2013,"12/11/2013"
"Devices",66389,"Ongoing","Baxter Healthcare Corp.","Deerfield","IL","US","Voluntary: Firm Initiated","Letter","Nationwide Distribution including WV, KY, IA, AR, OH, IL, IN, MI, KS, TN, WI, MN, MO.","Z-0392-2014","Class II","Baxter, VIAL-MATE Adaptor, 2B8071, Rx Only, STERILE R, Baxter Healthcare Corporation, Deerfield, IL 30015 USA The VIAL-MATE is reconstitution device labeled for use with 20 mm drug vials and 50mL, 100mL, and 250mL Single Pack Mini Bags.","Lot Number GR13G23028",".","38,400 units ","Incomplete foil seal on one lot of sterile product.",9/25/2013,"09/25/2013",12/4/2013,"12/04/2013"
"Devices",66391,"Ongoing","Wexford Labs Inc","Kirkwood","MO","US","Voluntary: Firm Initiated","Letter","Nationwide Distribution - USA including FL, SC, TX, MO, CA, OH, OK, MA, IN, and GA.","Z-0358-2014","Class II","Ready to Use Thymo-Cide, Germicidal Detergent, containing 0.051% thymol, packaged in 1-qt. bottles. The firm name on the label is Wexford Labs, Inc., Kirkwood, MO. For disinfection of hard, non-porous surfaces (floors, walls, tables, etc.) in operating rooms, intensive care, nurseries, emergency areas, dental operatories, police, EMS, and all health care facilities.","Lot numbers 091721, exp. 10/13; 101521, exp. 11/13; 0109131, exp. 2/14; 0215131, exp. 3/14; 0320131, exp. 4/14; 0415132, exp. 5/14; 0516131, exp. 6/14; and 0624131, 7/14.",,"7,020/1-qt. bottles (1755 gallons)","Expired active ingredient was used in the manufacture of the product.",9/10/2013,"09/10/2013",11/27/2013,"11/27/2013"
"Devices",66392,"Ongoing","Baxter Healthcare Corp.","Deerfield","IL","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution - USA Nationwide in the states of: AR, AZ, CA, CO, CT, FL, HI, IL, IN, KY, LA, MA, MD, MI, MN, MO, MS, NC, NH, NM, NY, OH, OK, OR, PA, TN, UT, VA, WA and WV and the country Canada.","Z-0189-2014","Class II","SIGMA SPECTRUM Infusion Pump with Master Drug Library component (SHARP LCD screen, 55074-2 revision B) Product Usage: Intended to be used as a visual aid during the controlled administration of intravenous fluids. These fluids may include pharmaceutical drugs, blood, blood products and mixtures of required patient therapy.","Product Code: 35700BAX & 35700ABB; Serial Numbers: 433713, 435563, 704056, 707290, 715315, 724216, 740127, 752318, 752447, 753675, 754947, 759766, 765934, 770034, 772017, 773470, 776507, 781016, 781969, 783352, 783454, 787567, 789720, 791225, 794828, 794990, 797185, 804798, 808393, 808764, 810971, 812076, 818718, 821213, 824067, 824198, 839143, 850028, 850577, 852007, 852431, 855450, 860201, 864799, 876765, 877548, 877944, 878637, 879810, 879886, 880022, 884707, 884778, 885565, 889416, 889814, 890949, 890987, 894957, 895413, 896662, 896912, 897576, 900401, 904778, 913511, 915035, 915981, 916173, 916948, 919159, 921162, 921937, 922515, 923861, 945583, 953011, 953360, 953995, 955881, 959847, 967694, 978892, 981692, 986022, 997333, 998512, 1002325, 1018432, 1018436, 1018737",".","93 units","Baxter Healthcare Corporation is recalling the LCD display screen on the SIGMA SPECTRUM Infusion Pump with Master Drug Library for not meeting standards for withstanding an electrostatic discharge. ",9/24/2013,"09/24/2013",11/20/2013,"11/20/2013"
"Devices",66394,"Ongoing","Alere San Diego, Inc.","San Diego","CA","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Worldwide Distribution - USA (nationwide) and countries of: South Africa and Canada","Z-0053-2014","Class III","Alere Triage TOX Drug Screen Control 1 Product Generic Name: Quality Control Material Description of the product: Good Laboratory Practice suggests that external controls should be tested with each new lot or shipment of test materials, or every 30 days, and as otherwise required by a laboratorys standard quality control procedures. The Alere Triage Drug Screen Controls, when used in accordance with the test procedures described in the Alere Triage TOX Drug Screen package insert, provide this capability. The results obtained for the controls are to be compared with the assigned values given on the Expected Values Card, accompanying the package insert, to determine if the procedure is within control limits. Alere Triage TOX Drug Screen Control 1 or Alere Triage TOX Drug Screen Control 2 consist of human urine matrix containing parent compounds and/or major metabolites/analogues of drugs of abuse. 510(k)/IDE/PMA number: K060788 Type of Packaging: 5 vials per level in a labeled kit box. Indications for use: The Alere Triage TOX Drug Screen Controls are to be used with the Alere Triage TOX Drug Screen tests and Alere Triage Meters to assist the laboratory in monitoring test performance.","Part Number 94413. Lot Number C2681A.",".","38","Alere San Diego, Inc. initiated a voluntary recall of Alere Triage TOX Drug Screen Control 1 (PN 94413, Lot C2681A) because the CODE CHIP that was provided with this lot causes the control to fail when run in the QC Sample Mode using Alere Triage TOX Drug Screeen products. The Alere Triage TOX Drug Screen test devices and patient results are not affected.",9/23/2013,"09/23/2013",10/30/2013,"10/30/2013"
"Food",66395,"Terminated","Taylor Farms Retail, Inc.","Salinas","CA","US","Voluntary: Firm Initiated","Telephone","One account in Canada.","F-1958-2013","Class II","Sensations Asian Supreme Salad Kit; 220 g/7.8 oz. Product os USA/Produit des E. U. A. Taylor Farms, Salinas, CA 93901","Best Before 2013 SE 26; Batch number WO2013252",".","749 cases, 6 x 7.8 oz bags per case.","Canadian product only - Sensations Spinach salad kit was packed in Sensations Asian Supreme Salad kit. The spinach kit contains feta cheese and milk is not listed on the ingredient statement as the source of the cheese as required by FALCPA.",9/18/2013,"09/18/2013",10/2/2013,"10/02/2013"
"Devices",66396,"Ongoing","Siemens Healthcare Diagnostics","Tarrytown","NY","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution - USA Nationwide in the states of: Argentina, Austria, Belgium, Bulgaria, Canada, Chile, China, Colombia, Croatia, Czech Republic, Denmark, Egypt, Estonia, France, French Polynesia, Germany, Guadeloupe, Guatemala, Great Britain, Greece, Korea, Indonesia, Israel, Italy, Kazakhstan, Latvia, Liechstenstein, Lithuania, Luxembourg, Macedonia, Martinique, Mexico, Netherlands, Norway, Peru, Poland, Portugal, Russian Federation, Serbia, Singapore, Slovenia, Slovakia, Spain, Sweden, Switzerland, Thailand, Taiwan, Tunisia, Turkey, United Arab Emirates, Uruguay, Vatican City, and Vietnam.","Z-0365-2014","Class II","Siemens Chemistry Calibrator (CAL) used with the ADVIA Chemistry Direct Bilirubin_2 Reagent, Siemens Material Number (SMN) 10312279, REF 09784096, Part Number T03-1291-62; IVD Product usage: Usage: DBIL_2: For in vitro diagnostic use in the quantitative determination of direct bilirubin in human serum and plasma on the ADVIA Chemistry systems. Such measurements are useful in the screening of liver function disorders or in the diagnosis of jaundice. ","Lots 090445B (exp. 07/2014) and 090445C (exp. 10/2014)",,"Domestic: 1191 units; Foreign: 3052 units","Siemens Healthcare Diagnostics is conducting a field correction for Siemens Chemistry Calibrator Lots 090445B and 090445C on the ADVIA 1200, 1650, 1800, and 2400 Chemistry Systems. The System Specific Values (SSVs) for the Direct Bilirubin Assay (DBIL_2) have been reassigned for these lots. Siemens has determined that the DBIL_2 SSVs currently assigned to these lots may cause an average shift of +7-9 % in quality control and sample recovery at a level of 3 mg/dL. This Urgent Medical Device Correction provides reassigned values for the DBIL_2 SSVs for Chemistry Calibrator Lots 090445B and 090445C.",9/24/2013,"09/24/2013",11/27/2013,"11/27/2013"
"Devices",66397,"Terminated","Beckman Coulter Inc.","Brea","CA","US","Voluntary: Firm Initiated","Telephone","Worldwide distribution: US (nationwide) in the state of: TX and countries of: Colombia, Hong Kong and Korea.","Z-0291-2014","Class II","Access 2 Immunoassay System, Part Number: 81600N The Access Immunoassay System is an in vitro diagnostic device used for the quantitative, semi-quantitative or qualitative determination of various analyte concentrations found in human body fluids.","Serial Numbers: 508801, 508802, 508803, 508804, 508805, 508806, 508807, 508810",".","8 units total (1 unit in the US)","Beckman Coulter is recalling the Access 2 Immunoassay System because they determined that the fuses in the system may be of the wrong amperage. ",9/12/2013,"09/12/2013",11/20/2013,"11/20/2013"
"Devices",66400,"Ongoing","Merit Medical Systems, Inc.","South Jordan","UT","US","Voluntary: Firm Initiated","Letter","US Distribution including the states of CO, VA, and MS.","Z-0045-2014","Class II","Merit Medical Performa Angiographic Catheter 5F Multipack. Part numbers 7560-43 and 7560-G3.","Part Number/Lot Number: 7560-43/I663860, 7560-43/I663861, 7560-G3/I664519 and 7560-G3/I666388. ",".","200","4 lots of Performa Cardiac Multipacks contain a JR4.0 catheter with a slight variation in tip shape.",9/13/2013,"09/13/2013",10/30/2013,"10/30/2013"
"Food",66401,"Terminated","Safeway Inc","Pleasanton","CA","US","Voluntary: Firm Initiated","E-Mail","Alaska, Arizona, California, Colorado, Washington, DC, Delaware, Hawaii, Idaho, Illinois, Maryland, Montana, Nebraska, New Mexico, Nevada, Oregon, Pennsylvania, South Dakota, Texas, Virginia, Washington and Wyoming","F-0126-2014","Class II","Angel Food Cake Fruit Topped; labeled for retail sale in the following stores: Safeway, Carrs, Dominicks, Genuardis, Pak N Save, Pavilions, Randalls, Tom Thumb and Vons. Angel Food Cake Fruit Topped 3 lb. 12 oz. (1701 g); Angel Food Cake Fruit Topped Black or White Base with Clear Lid; fruit topping.","sell by dates of 9/1/13 to 10/1/13.",".","2","Incorrect labels were provided to stores that omitted soy flour in ingredient statement. Soy oil and soy lecithin are listed in the ingredient statement.",9/25/2013,"09/25/2013",11/13/2013,"11/13/2013"
"Food",66401,"Terminated","Safeway Inc","Pleasanton","CA","US","Voluntary: Firm Initiated","E-Mail","Alaska, Arizona, California, Colorado, Washington, DC, Delaware, Hawaii, Idaho, Illinois, Maryland, Montana, Nebraska, New Mexico, Nevada, Oregon, Pennsylvania, South Dakota, Texas, Virginia, Washington and Wyoming","F-0122-2014","Class I","Angel Food Cake; labeled for retail sale in the following stores: Safeway, Carrs, Dominicks, Genuardis, Pak N Save, Pavilions, Randalls, Tom Thumb and Vons. Angel Food Cake 0 lb. 12 oz. (340 g) Black or White Base with Clear Lid","UPC code 211301010510 with sell by dates of 9/1/13 to 10/1/13.",".","70,162","Incorrect labels were provided to stores that omitted milk and soy.",9/25/2013,"09/25/2013",11/13/2013,"11/13/2013"
"Food",66401,"Terminated","Safeway Inc","Pleasanton","CA","US","Voluntary: Firm Initiated","E-Mail","Alaska, Arizona, California, Colorado, Washington, DC, Delaware, Hawaii, Idaho, Illinois, Maryland, Montana, Nebraska, New Mexico, Nevada, Oregon, Pennsylvania, South Dakota, Texas, Virginia, Washington and Wyoming","F-0123-2014","Class I","Holiday Decorated Angel Food Cake; labeled for retail sale in the following stores: Safeway, Carrs, Dominicks, Genuardis, Pak N Save, Pavilions, Randalls, Tom Thumb and Vons. Holiday Decorated Angel Food Cake 1 lb. 14 oz. (850 g); Black or White Base with Clear Lid; frosted/decorated","sell by dates of 9/1/13 to 10/1/13.",".","5","Incorrect labels were provided to stores that omitted milk and soy.",9/25/2013,"09/25/2013",11/13/2013,"11/13/2013"
"Food",66401,"Terminated","Safeway Inc","Pleasanton","CA","US","Voluntary: Firm Initiated","E-Mail","Alaska, Arizona, California, Colorado, Washington, DC, Delaware, Hawaii, Idaho, Illinois, Maryland, Montana, Nebraska, New Mexico, Nevada, Oregon, Pennsylvania, South Dakota, Texas, Virginia, Washington and Wyoming","F-0124-2014","Class II","Angel Food Cups 4 Count; labeled for retail sale in the following stores: Safeway, Carrs, Dominicks, Genuardis, Pak N Save, Pavilions, Randalls, Tom Thumb and Vons. Angel Food Cups 4 Count 0 lb. 3 oz. (85g); Individual cake cups sold in package of 4 items.","sell by dates of 9/1/13 to 10/1/13.",".","448","Incorrect labels were provided to stores that omitted milk and soy.",9/25/2013,"09/25/2013",11/13/2013,"11/13/2013"
"Food",66401,"Terminated","Safeway Inc","Pleasanton","CA","US","Voluntary: Firm Initiated","E-Mail","Alaska, Arizona, California, Colorado, Washington, DC, Delaware, Hawaii, Idaho, Illinois, Maryland, Montana, Nebraska, New Mexico, Nevada, Oregon, Pennsylvania, South Dakota, Texas, Virginia, Washington and Wyoming","F-0125-2014","Class I","Cake Angel Food Loaf: 1) Cake Angel Food Loaf; labeled for retail sale in the following stores: Safeway, Carrs, Dominicks, Genuardis, Pak N Save, Pavilions, Randalls, Tom Thumb and Vons. Cake Angel Food Loaf 0 lb. 4 oz. (113 g) Cake Angel Food Loaf Individual loaf sold in package of 1 item 2) Cake Angel Food Loaf - 2 count labeled for retail sale in the following stores: Safeway, Carrs, Dominicks, Genuardis, Pak N Save, Pavilions, Randalls, Tom Thumb and Vons. Angel Food Cake Loaf 2 Count 4 oz., and 10 oz. (283 g); Angel Food Cake Loaf 2 Count Individual loaf sold in package of 2 items.","sell by dates of 9/1/13 to 10/1/13.",".","1) 1099; 2) 4","Incorrect labels were provided to stores that omitted milk and soy.",9/25/2013,"09/25/2013",11/13/2013,"11/13/2013"
"Drugs",66402,"Ongoing","Tolmar, Inc.","Fort Collins","CO","US","Voluntary: Firm Initiated","Letter","Nationwide","D-66402-001","Class III","Ketoconazole Shampoo, 2%, Manufactured by TOLMAR Inc., Fort Collins, CO for Sandoz Inc., Princeton, NJ --- NDC 0781-7090-04. ","Lots: 6111A exp 8/14, 6191A exp 10/14, 5523A exp1/14, 5617A exp 2/14, 5619A exp2/14, 5660A exp 3/14, 5689A exp 3/14, 5690A exp 3/14, 6114A exp 9/14, 6115A exp 9/14,6118A exp 9/14, 6122A exp 9/14, 5307A exp 8/13, 5391A exp 10/13, 5393A exp 10/13, 5392A exp 10/13, 5394A exp 10/13, 5396A exp 11/13, 5430A exp 11/13, 5431A exp 11/13, 5432A exp 11/13, 5434A exp 11/13, 5578A exp 11/13, 5491A exp 11/13, 5492A exp 11/13, 5493A exp 12/13, 5494A exp 12/13, 5531A exp 1/14 5661A exp 3/14, 5490A exp 11/13, 5533A exp 2/14, 5495A exp 12/13, 5534A exp 2/14, 5535A exp 2/14, 5621A exp 2/14, 5728A exp 3/14, 6117A exp 9/14, 6113A exp 9/14, 5776A exp 4/14, 6112A exp 8/14, 6119A exp 9/14, 6192A exp 10/14,and 6123A exp 10/14",".","391,055 bottles","Subpotent",9/23/2013,"09/23/2013",10/30/2013,"10/30/2013"
"Drugs",66403,"Ongoing","Mylan Pharmaceuticals Inc.","Morgantown","WV","US","Voluntary: Firm Initiated","Letter","Nationwide and Puerto Rico","D-66403-007","Class II","Amlodipine Besylate and Benazepril HCl Capsules, 5 mg/20 mg, packaged in a) 100-count bottles (NDC 0378-6897-01) and b) 500-count bottles (NDC 0378-6897-05), Rx only, Mylan Pharmaceuticals Inc., Morgantown, WV 26505 U.S.A. ","Lot #: a) 2003169, 2003170, 2003171, 2003172, 2003173, 3043493; b) 2003168, 2003169, 3043493 ",".","60,506 bottles","CGMP Deviations: Pharmaceuticals were produced and distributed with active ingredients not manufactured according to Good Manufacturing Practices.",9/13/2013,"09/13/2013",11/13/2013,"11/13/2013"
"Drugs",66403,"Ongoing","Mylan Pharmaceuticals Inc.","Morgantown","WV","US","Voluntary: Firm Initiated","Letter","Nationwide and Puerto Rico","D-66403-012","Class II","Amlodipine Besylate Tablets, USP 10 mg, packaged in a) 90-count bottles (NDC 0378-5210-77) and b) 500-count bottles (NDC 0378-5210-05), Rx only, Mylan Pharmaceuticals Inc., Morgantown, WV 26505 U.S.A.","Lot #: a) 3038984, 3038985, 3038986, 3041484, 3041485; b) 3036828, 3036829, 3036830, 3036831, 3036832, 3038987, 3038988, 3038989, 3038990, 3041480, 3041481, 3041482, 3041483, 3044522, 3044525",".","101,450 bottles","CGMP Deviations: Pharmaceuticals were produced and distributed with active ingredients not manufactured according to Good Manufacturing Practices.",9/13/2013,"09/13/2013",11/13/2013,"11/13/2013"
"Drugs",66403,"Ongoing","Mylan Pharmaceuticals Inc.","Morgantown","WV","US","Voluntary: Firm Initiated","Letter","Nationwide and Puerto Rico","D-66403-001","Class II","Amlodipine Besylate Tablets, USP, 2.5 mg, packaged in a) 90-count bottles (NDC 0378-5208-77) and b) 500-count bottles (NDC 0378-5208-05), Rx only, Mylan Pharmaceuticals Inc., Morgantown, WV 26505 U.S.A.","Lot #: a) 3037907, 3040106; b) 3037907, 3040106, 3044357",".","37,752 bottles","CGMP Deviations: Pharmaceuticals were produced and distributed with active ingredients not manufactured according to Good Manufacturing Practices.",9/13/2013,"09/13/2013",11/13/2013,"11/13/2013"
"Drugs",66403,"Ongoing","Mylan Pharmaceuticals Inc.","Morgantown","WV","US","Voluntary: Firm Initiated","Letter","Nationwide and Puerto Rico","D-66403-008","Class II","Amlodipine Besylate and Benazepril HCl Capsules, 5 mg/40 mg, 100-count bottles, Rx only, Mylan Pharmaceuticals Inc., Morgantown, WV 26505 U.S.A., NDC 0378-6899-01","Lot #: 2003184, 2003185, 2003186, 3043495",".","11,701 bottles","CGMP Deviations: Pharmaceuticals were produced and distributed with active ingredients not manufactured according to Good Manufacturing Practices.",9/13/2013,"09/13/2013",11/13/2013,"11/13/2013"
"Drugs",66403,"Ongoing","Mylan Pharmaceuticals Inc.","Morgantown","WV","US","Voluntary: Firm Initiated","Letter","Nationwide and Puerto Rico","D-66403-004","Class II","Ciprofloxacin Tablets, USP, 250 mg, 100-count bottles, Rx only, Mylan Pharmaceuticals Inc., Morgantown, WV 26505 U.S.A., NDC 0378-7097-01 ","Lot #: 3032075, 3032076 ",".","521 bottles","CGMP Deviations: Pharmaceuticals were produced and distributed with active ingredients not manufactured according to Good Manufacturing Practices.",9/13/2013,"09/13/2013",11/13/2013,"11/13/2013"
"Drugs",66403,"Ongoing","Mylan Pharmaceuticals Inc.","Morgantown","WV","US","Voluntary: Firm Initiated","Letter","Nationwide and Puerto Rico","D-66403-011","Class II","Ciprofloxacin Tablets, USP, 500 mg,100-count bottles, Rx only, Mylan Pharmaceuticals Inc., Morgantown, WV 26505 U.S.A, NDC 0378-7098-01","Lot #: 2002732, 2002733, 2002734, 2002735, 2002736, 2002737, 2002738, 2002739, 2002740, 2002741, 2002742, 2002743, 2002744, 2002745, 3030000, 3030001, 3030002, 3030003, 3030004, 3030005, 3030006, 3030016, 3030017, 3030018, 3030216, 3030217, 3030218, 3030219, 3030220, 3030221, 3030222, 3030223, 3030224, 3030225, 3030226, 3030227, 3030228, 3030229, 3030238, 3030351, 3030352, 3030354, 3030355, 3030356, 3030357, 3030358, 3031790, 3031792, 3031793, 3031794, 3031795, 3031796, 3031797, 3031798, 3032035, 3032036, 3032037, 3032038, 3032039, 3032040, 3032041, 3032042, 3032043, 3032044, 3032045, 3032046 ",".","941,270 bottles","CGMP Deviations: Pharmaceuticals were produced and distributed with active ingredients not manufactured according to Good Manufacturing Practices.",9/13/2013,"09/13/2013",11/13/2013,"11/13/2013"
"Drugs",66403,"Ongoing","Mylan Pharmaceuticals Inc.","Morgantown","WV","US","Voluntary: Firm Initiated","Letter","Nationwide and Puerto Rico","D-66403-010","Class II","Amlodipine Besylate and Benazepril HCl Capsules, 10 mg/40 mg, 100-count bottles, Rx only, Mylan Pharmaceuticals Inc., Morgantown, WV 26505 U.S.A., NDC 0378-6900-01","Lot #: 2003188, 2003189, 2003190, 2003191, 3043498 ",".","23,356 bottles","CGMP Deviations: Pharmaceuticals were produced and distributed with active ingredients not manufactured according to Good Manufacturing Practices.",9/13/2013,"09/13/2013",11/13/2013,"11/13/2013"
"Drugs",66403,"Ongoing","Mylan Pharmaceuticals Inc.","Morgantown","WV","US","Voluntary: Firm Initiated","Letter","Nationwide and Puerto Rico","D-66403-005","Class II","Amlodipine Besylate Tablets, USP, 5 mg, packaged in a) 90-count bottles (NDC 0378-5209-77) and b) 500-count bottles (NDC 0378-5209-05), Rx only, Mylan Pharmaceuticals Inc., Morgantown, WV 26505 U.S.A. ","Lot s: a) 3036490, 3036491, 3036492, 3039874; b) 3036493, 3036494, 3039872, 3039873, 3041476, 3041477, 3044555, 3044683 ",".","167,866 bottles","CGMP Deviations: Pharmaceuticals were produced and distributed with active ingredients not manufactured according to Good Manufacturing Practices.",9/13/2013,"09/13/2013",11/13/2013,"11/13/2013"
"Drugs",66403,"Ongoing","Mylan Pharmaceuticals Inc.","Morgantown","WV","US","Voluntary: Firm Initiated","Letter","Nationwide and Puerto Rico","D-66403-006","Class II","Amlodipine Besylate and Benazepril HCl Capsules, 5 mg/10 mg, packaged in a) 100-count bottles (NDC 0378-6896-01) and b) 500-count bottles (NDC 0378-6896-05), Rx only, Mylan Pharmaceuticals Inc., Morgantown, WV 26505 U.S.A. ","Lot #: a) 2003159, 2003160, 2003161, 3043492; b) 2003158, 2003159, 3043492",".","30,878 bottles","CGMP Deviations: Pharmaceuticals were produced and distributed with active ingredients not manufactured according to Good Manufacturing Practices.",9/13/2013,"09/13/2013",11/13/2013,"11/13/2013"
"Drugs",66403,"Ongoing","Mylan Pharmaceuticals Inc.","Morgantown","WV","US","Voluntary: Firm Initiated","Letter","Nationwide and Puerto Rico","D-66403-009","Class II","Amlodipine Besylate and Benazepril HCl Capsules, 10mg/20mg, in 100 count bottles (NDC# 0378-6898-01) and 500 count bottles (NDC# 0378-6898-05) labeled in part ***Mylan Pharmaceuticals Inc. Morgantown, WV 26505 U.S.A.*** ","Lot #: a) 2003177, 2003178, 2003179, 2003180, 3043496; b) 2003176, 2003177, 3043496",".","42,174 bottles","CGMP Deviations: Pharmaceuticals were produced and distributed with active ingredients not manufactured according to Good Manufacturing Practices.",9/13/2013,"09/13/2013",11/13/2013,"11/13/2013"
"Drugs",66403,"Ongoing","Mylan Pharmaceuticals Inc.","Morgantown","WV","US","Voluntary: Firm Initiated","Letter","Nationwide and Puerto Rico","D-66403-003","Class II","Lamotrigine Tablets, USP, 200 mg, packaged in a) 60-count bottles (NDC 0378-4254-91) and b) 500-count bottles (NDC 0378-4254-05), Rx only, Mylan Pharmaceuticals Inc., Morgantown, WV 26505 U.S.A.","Lot #: a) 2003194, 2003195; b) 2003193 ",".","28,140 bottles","CGMP Deviations: Pharmaceuticals were produced and distributed with active ingredients not manufactured according to Good Manufacturing Practices.",9/13/2013,"09/13/2013",11/13/2013,"11/13/2013"
"Drugs",66403,"Ongoing","Mylan Pharmaceuticals Inc.","Morgantown","WV","US","Voluntary: Firm Initiated","Letter","Nationwide and Puerto Rico","D-66403-002","Class II","Amlodipine Besylate and Benazepril HCl Capsules, 2.5 mg/10 mg, 100-count bottles, Rx only, Mylan Pharmaceuticals Inc., Morgantown, WV 26505 U.S.A, NDC 0378-6895-01","Lot #: 2003156, 2003157, 2003155, 3043491",".","4,722 bottles","CGMP Deviations: Pharmaceuticals were produced and distributed with active ingredients not manufactured according to Good Manufacturing Practices.",9/13/2013,"09/13/2013",11/13/2013,"11/13/2013"
"Biologics",66404,"Terminated","OneBlood, Inc.","St Petersburg","FL","US","Voluntary: Firm Initiated","FAX","Florida","B-0013-14","Class II","Platelets Pheresis Leukocytes Reduced","W116313742872; ",,"1 unit","Blood product, with unacceptably high platelet count, was distributed.",9/10/2013,"09/10/2013",12/18/2013,"12/18/2013"
"Biologics",66405,"Terminated","Central Pennsylvania Blood Bank","Hummelstown","PA","US","Voluntary: Firm Initiated","FAX","Pennsylvania","B-0012-14","Class II","Red Blood Cells Leukocytes Reduced","W270113596965; ",,"1","Blood product, collected from a donor who received a body piercing within 12 months of donating, was distributed.",8/15/2013,"08/15/2013",12/18/2013,"12/18/2013"
"Devices",66407,"Ongoing","Olympus America Inc.","Center Valley","PA","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution - USA (nationwide) including Puerto Rico and Internationally to Canada.","Z-0432-2014","Class II","TB-0545PC: THUNDERBEAT 5 mm , 45 em, Pistol Grip TB-0535PC: THUNDERBEAT 5 mm, 35 em, Pi stol Grip TB-0545IC: THUNDERBEAT 5 mm, 45 em, In line Grip TB-0535IC: THUNDERBEAT 5 mm, 35 em, Inline Grip TB-0520IC: THUNDERBEAT 5 mm, 20 em, In line Grip TB-051 OIC: THUNDERBEAT 5 mm, I 0 em, In line Grip TB-545FC: THUNDERBEAT 5 mm, 45 em, Front Actuated Grip TB-0535FC: THUNDERBEAT 5 mm, 35 em, Front Actuated Grip The Olympus Thunderbeat Surgical Tissue Management System (''Thunderbeat'') is intended to be used for open, laparoscopic (including single-site surgery), and endoscopic surgery to cut (dissect) or coagulate soft tissue or to ligate (seal and cut) vessels.","All sold units",".","8709","Complaints of damage to various models of Thunderbeat Hand Instruments during surgical procedures, including cracking, breaking, or deformation of the components of the probe tip or jaw.",9/27/2013,"09/27/2013",12/11/2013,"12/11/2013"
"Devices",66408,"Ongoing","Hamilton Medical, Inc.","Reno","NV","US","Voluntary: Firm Initiated","Letter","Nationwide distribution: USA including Puerto Rico and the states of IL, MT, IN, ND, AZ, MT, KY, NC, OH, MA, MO, VA, CA, NV, TX, WA, NY, GA, SC,MN, WY, PA, ND, UT, NE, CO and MI.","Z-0170-2014","Class II","HAMILTON-C2 Ventilator: Manufactured by Hamilton Medical AG CH-7402 Bonaduz, Switzerland; Imported and distributed by Hamilton Medical, Inc. Reno, NV 89502 The HAMILTON C2 ventilator is intended to provide positive pressure ventilatory support to adults, pediatrics, infants and neonates depending on its configuration. Intended areas of use: In the intensive care ward or in the recovery room; During transfer of ventilated patients within the hospital.","Hamilton-C2; Serial numbers from 1000-7100. ",".","316 devices distributed in the US.","Manufacturer defined limits for improperly functioning loudspeakers of the HAMILTON C2 alarm system were exceeded.",9/26/2013,"09/26/2013",11/13/2013,"11/13/2013"
"Devices",66409,"Ongoing","Synthes USA HQ, Inc.","West Chester","PA","US","Voluntary: Firm Initiated","Letter","Nationwide Distribution including WA, FL, LA, TX, GA, IN, OH, CA, MI, and PA.","Z-0474-2014","Class II","Synthes Trochanteric Fixation Nail As part of the Synthes Trochanteric Fixation Nail (TFN) System, the TFN Nail is intended to treat stable and unstable fractures of the proximal femur. ","Part 456.475S, lot # 7121831 and Part 456.637S, lot #7121832, expiration 11/30/21. ",,"12","Certain lots of Trochanteric Fixation Nail were distributed to the field with the incorrect labeling of the length and diameter of the nail on the packaging. ",7/30/2013,"07/30/2013",12/18/2013,"12/18/2013"
"Devices",66410,"Ongoing","S.A.E. AFIKIM","Kibbutz Afikim",,"IL","Voluntary: Firm Initiated","Press Release","Nationwide Distribution: US including the states of California, Florida, Georgia, Illinois, Maine, Maryland, Massachusetts, Michigan, Minnesota, New Jersey, New York, Ohio, Oklahoma, Pennsylvania, Texas, Virginia, and Wisconsin.","Z-0115-2014","Class II","Breeze C Scooter is a motorized electric scooter for elderly people. Brand name Breeze, model C. It is intended to provide increased mobility for elderly and/or disabled person and it is also an aid to independent living. Products can be identified by their color; the recalled products are either metallic blue or metallic silver. The products have two rear wheels and have either one or two wheels in the front. The scooters have an adjustable swivel seat and a front storage basket; some scooters may be fitted with an optional larger rear basket. ","Serial Numbers: 10390024, 10390025, 10390029, 10390030, 10390034, 10390037, 10490100, 10490108, 10490111, 10490113, 10490119, 10490121, 10490124, 11390058, 11390060, 11390061, 11390069, 11390074, 11390095, 11390101, 11490111, 11490147, 11490176, 11490189, 11490277, 11490304, 11490305, 11490425, 11490426, 11490433, 11490435, 11490445, 12390096, 12390097, 12390098, 12390099, 12390101, 12390102, 12390103, 12390104, 12390105, 12390106, 12390107, 12390117, 12390120, 12490169, 12490170, 12490172, 12490173, 12490174, 12490175, 12490176, 12490177, 12490178, 12490179, 12490180, 12490181, 12490182, 12490183, 12490184, 12490185, 12490186, 12490187, 12490188, 12490189, 12490190, 12490191, 12490192, and 12490193. ",,"69 units","Breeze C Scooter, motorized 3-wheeled electric scooter for elderly people, is recalled because it may become unresponsive during operation due to an electrical contact which may fault due to extensive wear, which potentially could result in the driver not being able to stop the scooter during operation except by turning off the ignition key.",9/27/2013,"09/27/2013",11/6/2013,"11/06/2013"
"Devices",66411,"Ongoing","Synthes USA HQ, Inc.","West Chester","PA","US","Voluntary: Firm Initiated","Letter","Nationwide Distribution including PA, CA, FL, MO, KS, IN, IL, WV, KY, LA, NM, SC, IA, TX, AZ, GA, NC, OK, NY, TN, MI, CO, and MT.","Z-0380-2014","Class II","2.4 and 2.7 MM Locking Screw SLF-TPNG with T8 Stardrive Recess 12 MM Fixation of fractures, osteotomies, nonunions, replantations, and fusions of small bones and small bone fragments, particularly in osteopenic bone. ","Lot 3420620",".","98","Specific lots of the SS 2.4mm and SS 2.7mm Locking Screw (self-tapping) due to a mislabeling issue. The SS 2.7mm Screw was labeled as SS 2.4 mm Screw.",7/31/2013,"07/31/2013",12/4/2013,"12/04/2013"
"Devices",66412,"Ongoing","Synthes USA HQ, Inc.","West Chester","PA","US","Voluntary: Firm Initiated","Letter","USA Nationwide Distribution","Z-0408-2014","Class II","Slipped Capital Femoral Epiphysis System Product Usage: Intended for fracture fixation of large bones and large bone fragments and for slipped capital femoral epiphysis, pediatric femoral neck fractures, intercondylar femur fractures and sacroiliac joint disruptions.","Parts 03.207.001 and 03.207.008 with lot numbers: Part # Lot # 03.207.001 PE00376 PE00439 PE01391 PE01329 PE01412 PE00504 03.207.008 PE00440 PE00377 PE00513 PE01475 PE01691 ",".","166","There is a possibility for the Guide Wires of the Slipped Capital Femoral Epiphysis System to stick in the cannulation of the drill bit and the drill bits to break during surgery. ",7/31/2013,"07/31/2013",12/4/2013,"12/04/2013"
"Devices",66413,"Ongoing","Synthes USA HQ, Inc.","West Chester","PA","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution - USA (nationwide) including IN, NY, WA, NE, MD, TX, AL, MI, and Internationally to Canada.","Z-0406-2014","Class II","Synthes 2.4 mm LC-DCP Plate 6 Holes/51mm Product Usage: Intended for fractures, osteotomies, and replantations of small bones including the foot, ankle, and hand. ","Part No. 249.926, lot No. 8093100",".","13","A complaint was reported regarding a screw being found in a package labeled for 2.4 mm LC-DCP Plate.",7/30/2013,"07/30/2013",12/4/2013,"12/04/2013"
"Devices",66414,"Ongoing","Synthes USA HQ, Inc.","West Chester","PA","US","Voluntary: Firm Initiated","Letter","Nationwide Distribution including IN, MT, HI, and FL.","Z-0410-2014","Class II","Vertebroplasty Needle Kit 10g Diamond Tip Intended to be used to inject PMMA cement into vertebral bodies during Vertebroplasty procedure.","Part No. 03.702.218S, Lot No. AJM838X",".","40","Complaints were received of inconsistencies in the expiration dates shown on the packaging of the Vertebroplasty Needle Kit 10g Diamond Tip device.",7/30/2013,"07/30/2013",12/4/2013,"12/04/2013"
"Devices",66415,"Ongoing","Synthes USA HQ, Inc.","West Chester","PA","US","Voluntary: Firm Initiated","Letter","Worldwide distribution: US (nationwide) and countries of Canada and Switzerland.","Z-0384-2014","Class II","Synthes Matrix Threaded Persuader Deformity is a comprehensive thoracolumbar pedical screw system designed to provide flexibility biomechanical performance and a solution to complex posterior pathological challenges. ","Item Lot Number Number 03.632.008 4833901 03.632.008 6284014 03.632.008 6284015 03.632.008 6377412 03.632.008 6390270 03.632.008 6390308 03.632.008 6390309 03.632.008 6445711 03.632.008 6455761 03.632.008 6455786 03.632.008 6530998 03.632.008 6548747 03.632.008 6558995 03.632.008 6559002 03.632.008 6583188 03.632.008 6583189 03.632.008 6603334 03.632.008 6603335 03.632.008 6624550 03.632.008 6676663 03.632.008 6703414 03.632.008 6706733 03.632.008 6718634 03.632.008 6718635 03.632.008 4833901 03.632.008 6445711 03.632.008 6455761 03.632.008 6455786 03.632.008 6530998 03.632.008 6548747 03.632.008 6603334 03.632.008 6603335 03.632.008 6676663 03.632.008 6703414 03.632.008 6706733 03.632.008 6718634 03.632.008 6718635 ",".","634","Synthes became aware that during a procedure using the Matrix Threaded Persuader, the Reduction Insert malfunctioned causing pieces to break off. Once there is a breakage to the Reduction Insert it will not allow the instrument to function as required.",7/31/2013,"07/31/2013",12/4/2013,"12/04/2013"
"Devices",66416,"Ongoing","Synthes USA HQ, Inc.","West Chester","PA","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution - USA (nationwide) including GA, FL, CA, UT, IA, AZ, OH and Internationally to Canada.","Z-0391-2014","Class II","Synthes Matrix 5.5.mm Left and Right Coronal Bender Product Usage: The Matrix 5.5.mm Left and Right Coronal Bender are used together to bend the 5.5 Matrix Rods in the coronal plane, and is intended for stabilization of the thoracic, lumbar, sacral, and/or iliac spine through screw and/or hook and rod fixation.","Parts 03.632.040 and 03.632.041 with various lot nos. Item Lot Number Number 03.632.040 T935338 03.632.040 T939100 03.632.040 T945062 03.632.040 T953982 03.632.040 T956310 03.632.040 T959990 03.632.040 T959995 Item Lot Number Number 03.632.041 T935343 03.632.041 T939105 03.632.041 T939755 03.632.041 T945067 03.632.041 T952750 03.632.041 T956315 03.632.041 T960000 03.632.041 T960005 ",".","209","A complaint was received of the tips of the Matrix 5.5.mm Left and Right Coronal Bender breaking while bending a spinal rod component of the Matrix System.",6/22/2013,"06/22/2013",12/4/2013,"12/04/2013"
"Devices",66417,"Ongoing","Synthes USA HQ, Inc.","West Chester","PA","US","Voluntary: Firm Initiated","Letter","Nationwide Distribution including IL, CA, AZ, FL, TX, UT, VA, NY, NM, and MT.","Z-0452-2014","Class II"," Titanium Trochanteric Fixation Nail (TFN)System Intended to treat stable and unstable fractures of the proximal femur. ","Part # 456.391S with lot numbers 5536930, exp. 5/20/2016, and 7161401, exp. 12/31/2021. ",".","17","Three lots of Titanium Trochanteric Fixation Nail (TFN) System are missing the second bend in the nail. ",7/30/2013,"07/30/2013",12/11/2013,"12/11/2013"
"Devices",66418,"Ongoing","Synthes USA HQ, Inc.","West Chester","PA","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution - USA including ID, FL, TN, NY, LA and Internationally to Canada.","Z-0409-2014","Class II","Synthes 4.5 mm LCP Curved Condylar Plate Intended for buttressing multifragmentary distal femur fractures. ","Part No. 02.001.324, lot no. 6900823",".","13","The Synthes 4.5 mm LCP Curved Condylar Plate was recalled because a Straight Condylar Plate is etched with a Curved Condylar Plate part number.",7/30/2013,"07/30/2013",12/4/2013,"12/04/2013"
"Devices",66419,"Ongoing","Synthes USA HQ, Inc.","West Chester","PA","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution - USA (nationwide) including SC, IA, NC, TX, KY, VA, AL, PA, and Internationally to Canada","Z-0407-2014","Class II","Synthes Titanium Cannulated Humeral Nail Intended to aid in the alignment and stabilization of humeral fractures","Part # Lot # 04.001.620S 7115414 04.001.620S 7115417 04.001.620S 7115509 04.001.620S 7115510 04.001.622S 7115533 04.001.636S 7117902 04.001.636S 7117916 04.001.638S 7117924 04.001.640S 7119089 04.001.640S 7119107 04.001.642S 7117995 04.001.642S 7119125 04.001.644S 7117998 04.001.218S 7327816 04.001.444S 7379241 04.001.620s 7265517 ",".","14","The packaging incorrectly depicts the Synthes Titanium Cannulated Humeral Nail as a 3 distal hole nail instead of a 2 distal locking hole nail. ",7/30/2013,"07/30/2013",12/4/2013,"12/04/2013"
"Devices",66420,"Ongoing","Synthes USA HQ, Inc.","West Chester","PA","US","Voluntary: Firm Initiated","Letter","Nationwide Distribution.","Z-0388-2014","Class II","Synthes Tensioning Device The Synthes Osteogenesis System, MR Conditional is intended for fracture fixation (open and closed), pseudoarthrosis or non-unions of long bones, limb lengthening by epiphyseal or metaphyseal distraction, correction of bony or soft tissue deformities and correction of segmental bony or soft tissue defects in adult and pediatric patients.","all lots of model number 03.311.001: Part # Synthes lot # 03.311.001 1934765 03.311.001 1934766 03.311.001 1993844 03.311.001 3036688 03.311.001 3398576 03.311.001 3776484 03.311.001 5100597 03.311.001 5106354 03.311.001 5160872 03.311.001 5160875 03.311.001 5174253 03.311.001 5174253 03.311.001 5174254 03.311.001 5181000 03.311.001 5181001 03.311.001 5196282 03.311.001 5196283 03.311.001 5197081 03.311.001 5241942 03.311.001 5241943 03.311.001 5336723 03.311.001 5363637 03.311.001 5396016 03.311.001 5411479 03.311.001 5555521 ",".","369","All lots of the Synthes Tensioning Device were recalled due to the potential for the reaction fork to come loose from the main body of the device and not allow the wire to release, nor the device to apply tension.",7/31/2013,"07/31/2013",12/4/2013,"12/04/2013"
"Devices",66421,"Ongoing","Synthes USA HQ, Inc.","West Chester","PA","US","Voluntary: Firm Initiated","Letter","US Distribution including the states of TX, PA, NY, GA, CO, IN, AI, AR, IL, MI, TN, CA, AZ, MS and VA.","Z-0387-2014","Class II","Large Buttress Compression Nut For Blade Guide Sleeve TFN The Synthes Large Buttress Compression Nut For Blade Guide Sleeve TFN is intended to treat stable and unstable pertrochanteric fractures, intertrochanteric fractures, basal neck fractures, and combinations there of.","Part # Lot # SD357.371 5734551 6083065 6538811 6631975 6703191 6703190 6841538 ",".","135","The Large Buttress Compression Nut For Blade Guide Sleeve TFN was recalled because of complaints that the compression nut did not thread completely onto the blade guide sleeve and became stuck. ",7/31/2013,"07/31/2013",12/4/2013,"12/04/2013"
"Drugs",66422,"Ongoing","Hospira Inc.","Lake Forest","IL","US","Voluntary: Firm Initiated","Letter","Nationwide and Puerto Rico","D-013-2014","Class II","Ondansetron Injection, USP, 4 mg/2 mL (2 mg/mL), 2 mL Single-dose Vial, Rx Only, Sterile, Hospira Inc., Lake Forest IL 60045, USA, NDC 0409-4755-03","29-484-DK* and 29-510-DK* Exp 05/01/2015 (lot number may be proceeded with an 01)",,"681,400 vials","Presence of Particular Matter: Potential vendor glass issue - glass spiticules (glass strands) were identified during site inspection of the vials.",9/24/2013,"09/24/2013",11/27/2013,"11/27/2013"
"Drugs",66422,"Ongoing","Hospira Inc.","Lake Forest","IL","US","Voluntary: Firm Initiated","Letter","Nationwide and Puerto Rico","D-012-2014","Class II","Metoclopramide Injection, USP 10 mg (5mg/mL), 2 mL Single-dose Vial, Rx Only, Sterile, Hospira Inc., Lake Forest, IL, 60045, USA, NDC 0409-3414-01","Lot #: 28-104-DK*, Exp 10/01/2014 (* lot number may be proceeded with an 01)",,"251,400 vials","Presence of Particulate Matter: Potential vendor glass issue - glass spiticules (glass strands) were identified during site inspection of the vials.",9/24/2013,"09/24/2013",11/27/2013,"11/27/2013"
"Devices",66423,"Ongoing","Helix Medical LLC","Carpinteria","CA","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution-USA (nationwide) and the countries of Belgium, Canada, Croatia, Germany, Ireland, and Italy.","Z-0128-2014","Class III","Blom-Singer Adjustable Tracheostoma Valve II Models: BE8025H and BE8025H-R3","LOTS: 1057760, 1057919 and 1059222",".","47 units","InHealth Technologies (IHT) is recalling the Blom-Singer Adjustable Tracheostoma Valve II (ATSV II) because the body component of the device is missing from the packaging. The ATSV II Valve product cannot be used as intended without the product body.",10/1/2013,"10/01/2013",11/13/2013,"11/13/2013"
"Devices",66424,"Terminated"," AGFA Corp.","Greenville","SC","US","Voluntary: Firm Initiated","Letter","Worldwide distrbution: US(nationwide) distribution including NY and OK, and country of Canada.","Z-0035-2014","Class II","IMPAX 5.2 DB Server (running Oracle 10.1.0.4.0), medical imaging Picture Archiving and Communication System (PACS).","N/A",".","4","System downtime and/or slow performance may result if software in use is an old version of IMPAX and is not at current supported levels.",9/19/2013,"09/19/2013",10/30/2013,"10/30/2013"
"Devices",66425,"Ongoing","Insulet Corporation","Bedford","MA","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution - USA Nationwide and the country of Israel.","Z-0165-2014","Class II","OmniPod Insulin Management System Starter Kit; Model Reference Number: SKT-UST400 (Starter Kit) Product Usage: The Starter Kit (SKT-UST400) is provided to users as an introduction to the OmniPod Insulin Management System prior to initiating care. It includes the Personal Diabetes Manager (PDM) with two AAA alkaline batteries, a USB cable, a Users Guide, a Soft Carrying Case, a Troubleshooting guide, a Warranty Registration Card, and two Alcohol Pads. The OmniPod Insulin Management System is intended for subcutaneous delivery of insulin at set and variable rates for the management of diabetes mellitus in persons requiring insulin and for the quantitative measurement of glucose in fresh whole capillary blood (in vitro) from the finger. The glucose measurements should not be used for the diagnosis of or screening for diabetes. The PDM glucose meter is intended for single-patient use and should not be shared. Abbott FreeStyle test strips are used with the built-in FreeStyle meter for the quantitative measurement of blood glucose in fresh whole capillary blood from the finger, upper arm and palm. Abbott Freestyle Control Solutions are used to verify that the meter and test-strips are working together properly and that the test is performed correctly.","Lot Numbers: L13483, L13485, L13478, & L13481",".","1,719 starter kits","Alcohol Prep Pads contained within the kit are not properly labeled. ",9/27/2013,"09/27/2013",11/13/2013,"11/13/2013"
"Devices",66425,"Ongoing","Insulet Corporation","Bedford","MA","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution - USA Nationwide and the country of Israel.","Z-0166-2014","Class II","OmniPod Insulin Management Product Demonstration Kit; Model Reference Number: (PDK-ZXP490) Product Usage: The Demonstration Kit (PDK-ZXP490) is an alternate kit provided to potential patients by healthcare professionals for patients to experience what wearing a Pod may feel like prior to purchase. Each Demonstration Kit includes a UST400 brochure, one Alcohol Pad, and a Pod. The OmniPod Insulin Management System is intended for subcutaneous delivery of insulin at set and variable rates for the management of diabetes mellitus in persons requiring insulin and for the quantitative measurement of glucose in fresh whole capillary blood (in vitro) from the finger. The glucose measurements should not be used for the diagnosis of or screening for diabetes. The PDM glucose meter is intended for single-patient use and should not be shared. Abbott FreeStyle test strips are used with the built-in FreeStyle meter for the quantitative measurement of blood glucose in fresh whole capillary blood from the finger, upper arm and palm. Abbott Freestyle Control Solutions are used to verify that the meter and test-strips are working together properly and that the test is performed correctly. ","Lot Numbers: L13470",".","5,050 kits","Alcohol Prep Pads contained within the kit are not properly labeled. ",9/27/2013,"09/27/2013",11/13/2013,"11/13/2013"
"Food",66426,"Ongoing","Giant Eagle, Inc.","Pittsburgh","PA","US","Voluntary: Firm Initiated","FAX","MD, OH, PA, WV","F-0102-2014","Class I","Giant Eagle Candy Place Candy Corn Mix in a clear plastic container, net wt. 13 oz, Distributed by Giant Eagle Inc. UPC#3003406974","Sell By Date 040814",".","80 cases (960 units) George Howe/79 cases (948 units) Giant Eagle","Undeclared milk, egg, peanut, and soy allergens in Giant Eagle Candy Place Candy Corn Mix",9/25/2013,"09/25/2013",11/13/2013,"11/13/2013"
"Devices",66431,"Ongoing","Hospira Inc.","Lake Forest","IL","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution-USA (nationwide) including the states of AL, AZ, CA, CO, FL, GA, IL, IN, KS, MD, MI, MN, MO, MT, NC, ND, NE, NJ, NY, PA, SD, TX, UT, VA, and WA and countries of: Canada and EMEA.","Z-0457-2014","Class II","Product is labeled in part: LIST NO. 43449; RECEPTAL CANISTER; DO NOT FILL 900 ABOVE THIS LINE; Product of China; Hospira, Inc.,; Lake Forest, IL 60045 USA. Used to isolate suction waste during surgeries, or to clear patient airways, throat or wounds to allow treatment.","*** DOMESTIC PRODUCT *** List Numbers: 43449-04-11 and 43449-04-01; Lot Numbers: All; *** FOREIGN PRODUCT *** List Numbers: 0L21297W1, 0L2129701, 0L2139701, 43449001L, 434490101, 434490102, 434490181, 434490181, 434490182, 4344901DX, 434496101, 434496161, 4344961A1, 434499090; Lots: All",,"3,560 units distributed from June 2004 - December 2012","Hospira has recieved reports that the vacuum needed to create suction with the 1L Receptal System cannot be achieved due to the canister and liner not properly seating.",7/17/2013,"07/17/2013",12/18/2013,"12/18/2013"
"Veterinary",66432,"Ongoing","Cargill Inc.","Alexander","NY","US","Voluntary: Firm Initiated","Telephone","New York","V-005-2014","Class II","Agway LS Meat Goat 16 PL (DQ) (AX) MEDICATED, Net Wt. 50 lb poly bags","Product Code 200593, Lot #AX3242 ",,"11 bags","Cargill Feed & Nutrition has recalled Agway LS Meat Goat 16 Pellet with Decox due to the presence of excessive amounts of selenium. ",9/27/2013,"09/27/2013",11/27/2013,"11/27/2013"
"Devices",66433,"Ongoing","Atossa Genetics, Inc.","Seattle","WA","US","Voluntary: Firm Initiated","Press Release","USA Nationwide Distribution in the states of: AL, CA, FL, GA, IL, IN, KY, MD, ME, MI, MO, NC, ND, NJ, NV, NY, OK, PA, SC, TN, TX, UT, VA, WA, Washington DC, and Puerto Rico.","Z-0042-2014","Class I","Brand: The ForeCYTE Breast Health Test, Mammary Aspiration Specimen Cytology Test (MASCT), MASCT System Kits, Clarity System Kits, MASCT Patient Sample Kits & Clarity Patient Sample Kits Instrument, Biopsy. The MASCT System Kit, Patient Sample Kits, or the Nipple Aspirate Fluid Laboratory Kit has the following codes: PRODUCT CODE: AG-MASCT; AG-FC5; DTG-MASCT, DTG-FC5, and NRLBH-5. PART NUMBER: 9002513; 9002513MD; 9002528; 9002528MD; 9002587; 9002614; and 9002717MD. THE MASCT SYSTEM KIT CONSISTS OF: 1. MASCT Breast Pump; 2. Instructions for Use (IFU); 3. Heating Pad; 4. Timer; 5. Saccomono's Fixative; 6. Nu Prep Gel; 7. Welcome and Training Materials Coversheet; 8. MASCT System Order Form; 9. ForeCYTE Training Video DVD; 10. MASCT System Instructions with pictures - pink; THE PATIENT SAMPLE KIT CONSISTS OF: 1. Two (2) flower assemblies (e.g., filter, filter retainer, and filter holder); 2. Instructions for Use (IFU); 3. Two (2) specimen collection devices; 4. Two (2) breast bags for transporting the specimen collection container; 5. Barcode labels; 6. Saccomono's Fixative; 7. Nu Prep Gel; 8. MASCT System package insert; 9. ForeCYTE Test Requisition Form; 10. Patient Information Sheet; 11. Atossa Patient Information; 12. FED EX Clinical PAK; 13. MASCT System Order Form; 14. FED EX Pouch; 15. FED EX Airbill; Product Usage: The MASCT Device is intended for use in the collection of nipple aspirate fluid for cytological testing. The collected fluid can be used in the determination and/or differentiation of normal versus premalignant versus malignant cells. ","ALL LOTS",,"577 MASCT System kits, 101 Lab Kits, and 2557 Patients Kits (5 test per kit)","Atossa Genetics is recalling ForeCYTE Breast Health Test, Mammary Aspiration Specimen Cytology Test (MASCT) due concerns raised by the U.S. Food and Drug Administration (FDA) in a warning letter received by Atossa in February 2013. The FDA raised concerns about (1) the current Instructions for Use (IFU); (2) certain promotional claims used to market these devices; and (3) the need for FDA clearance for certain changes made to the Nipple Aspirate Fluid (NAF) specimen collection process identified in the current IFU. ",9/19/2013,"09/19/2013",11/6/2013,"11/06/2013"
"Devices",66434,"Terminated","Intuitive Surgical, Inc.","Sunnyvale","CA","US","Voluntary: Firm Initiated",,"Worldwide Distribution-USA (nationwide) including Puerto Rico and the countries of Australia, Austria, Belgium, Canada, Chile, China, Denmark, Egypt, Finland, France, Greece, Germany, India, Indonesia, Israel, Ireland, Italy, Kuwait, Mexico, Netherlands, Norway, Philippines, Poland, Portugal, Qatar, Romania, Saudi Arabia, Singapore, Slovakia, South Korea, Spain, Sweden, Switzerland, Taiwan, Thailand, Turkey, and United Kingdom.","Z-0088-2014","Class II","da Vinci Si Surgical System IS3000 with the da Vinci Surgeon Console which contains a high Resolution Stereoscopic Viewer. Intended to assist in the accurate control of Intuitive Surgical Endoscopic instruments.","model numbers 380610-04 through 38-610-14.",,"1,090 consoles","Improper restraints during transportation of the da Vinci system could cause the HRSV Monitor to become loose from its mount.",10/17/2011,"10/17/2011",11/6/2013,"11/06/2013"
"Drugs",66435,"Ongoing","Hospira, Inc.","Lake Forest","IL","US","Voluntary: Firm Initiated","Letter","Nationwide","D-023-2014","Class II","Morphine Sulfate Injection, USP, (25mg/mL), 250 mg, 10mL Fill, Single dosage Flip top Vial, (C-II), (NDC 0409-1135-02), Rx Only, Manfactured for Hospira, Inc., Lake Forest, IL 60045 USA. ","Lot #17368EV Exp 08/13",".","29,700 vials","Lack of Assurance of Sterility: Confirmed customer report of leakage of vial contents due to the breaking of the vial neck. ",9/16/2013,"09/16/2013",12/11/2013,"12/11/2013"
"Food",66436,"Ongoing","Gold Medal Products","Cincinnati","OH","US","Voluntary: Firm Initiated","telephone","The affected product was distributed in the following states: AK, AR, AZ, CA, CT, GA, IA, ID, IN, MA, MT, PA, TX & WI. The affected product was also distributed to Canada.","F-0710-2014","Class II","Product #4123: Caramel dip in metal #10 containers","All containers dated between June 2013 and August 2013. ",".","50 case with 6 containers per case","The firm received notification that the products were manufactured under insanitary conditions. ",9/24/2013,"09/24/2013",12/11/2013,"12/11/2013"
"Food",66436,"Ongoing","Gold Medal Products","Cincinnati","OH","US","Voluntary: Firm Initiated","telephone","The affected product was distributed in the following states: AK, AR, AZ, CA, CT, GA, IA, ID, IN, MA, MT, PA, TX & WI. The affected product was also distributed to Canada.","F-0709-2014","Class II","Product #4124: Caramel dip in plastic containers","All containers dated between June 2013 and August 2013. ",".","83 cases, with 4 containers per case","The firm received notification that the products were manufactured under insanitary conditions. ",9/24/2013,"09/24/2013",12/11/2013,"12/11/2013"
"Devices",66439,"Ongoing","Zimmer, Inc.","Warsaw","IN","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution - USA (nationwide) and Internationally to Nationwide and OUS countries include: Australia, Austria, Belgium, Canada, France, Germany, Italy, New Zealand, Spain, Switzerland, and the UK.","Z-0357-2014","Class II","Trinica Anterior Lumbar Plate (ALP) system, part 07.01058.001. Non Sterile, Rx only. The Trinica Anterior Lumbar Plate System is a temporary supplemental fixation device consisting of a variety of shapes and sizes of plates and screws. The Trinica Anterior Lumbar Plate System is used as an implant for the correction and stabilization of the spine. This system provides temporary stabilization and augments the development of a solid spinal fusion. Additionally, this system provides the surgeon with the ability to supplement an interbody device with anterior plate fixation. The Trinica Anterior Lumbar Plate System components can be locked into a variety of configurations and each construct may be customized to individual cases. The plates are low profile and anatomically designed to provide optimal fit from either anterior or anterior-lateral approach. This system also features anti-migration locking caps to help secure the fixation screws. All Trinica Anterior Lumbar Plate System implant components are made from titanium alloy (Ti-6AI-4V). The Trinica Anterior Lumbar Plate System is indicated for use via the lateral or anterolateral surgical approach above the bifurcation of the great vessels or via the anterior surgical approach, below the bifurcation of the great vessels. This system is indicated in the treatment of lumbar or lumbosacral (L1-SI) spine instability as a result of fracture (including dislocation and subluxation), tumor, degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies), pseudoarthrosis, spondylolisthesis, scoliosis, lordotic deformities of the spine, spinal stenosis, or a failed previous fusion.","Lots: P060509, P061255, P070617, P080422, P090046",,"94 Tray sets","Zimmer Spine, Inc. is initiating a correction regarding the Trinica ALP Instrument Tray, part 07.01058.001 (all lots). The Ratchet Handles, part 07.00438.001 may not be effectively sterilized if left in their designated location(s) in the instrument tray. This is due to the current bracketing in the tray potentially interfering with complete steam penetration into the cannulated handle. ",10/9/2013,"10/09/2013",11/27/2013,"11/27/2013"
"Food",66442,"Ongoing","The Dannon Company, Inc.","Tarrytown","NY","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Product distributed to Arizona, California, Colorado, Idaho, Nevada, Oregon, Utah, and Washington. Including Govt/military/VA.","F-0127-2014","Class II","Dannon LIGHT & FIT Nonfat Yogurt - 4 PACK of 6 oz cups. Vanilla UPC 36632 02721","Expiration code OCT 27 2013 WE",".","3227","Dannon Company, Inc. is recalling Light n Fit Nonfat Yogurt because they may contain yeast.",9/27/2013,"09/27/2013",11/20/2013,"11/20/2013"
"Food",66442,"Ongoing","The Dannon Company, Inc.","Tarrytown","NY","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Product distributed to Arizona, California, Colorado, Idaho, Nevada, Oregon, Utah, and Washington. Including Govt/military/VA.","F-0128-2014","Class II","Dannon LIGHT & FIT Nonfat Yogurt - 4 PACK of 6 oz cups. Peach UPC 36632 02722.","Expiration code OCT 27 2013 WE",".","4226 cases","Dannon Company, Inc. is recalling Light n Fit Nonfat Yogurt because they may contain yeast.",9/27/2013,"09/27/2013",11/20/2013,"11/20/2013"
"Food",66442,"Ongoing","The Dannon Company, Inc.","Tarrytown","NY","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Product distributed to Arizona, California, Colorado, Idaho, Nevada, Oregon, Utah, and Washington. Including Govt/military/VA.","F-0131-2014","Class II","Dannon LIGHT & FIT Nonfat Yogurt - 4 PACK of 6 oz cups. Cherry UPC 36632 02180.","Expiration code OCT 27 2013 WE",".","1620 cases","Dannon Company, Inc. is recallingLight n Fit Nonfat Yogurt because they may contain yeast.",9/27/2013,"09/27/2013",11/20/2013,"11/20/2013"
"Food",66442,"Ongoing","The Dannon Company, Inc.","Tarrytown","NY","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Product distributed to Arizona, California, Colorado, Idaho, Nevada, Oregon, Utah, and Washington. Including Govt/military/VA.","F-0132-2014","Class II","Dannon LIGHT & FIT Nonfat Yogurt - 4 PACK of 6 oz cups. Blueberry UPC 36632 02723.","Expiration code OCT 27 2013 WE",".","4775 cases","Dannon Company, Inc. is recalling Light n Fit Nonfat Yogurt because they may contain yeast.",9/27/2013,"09/27/2013",11/20/2013,"11/20/2013"
"Food",66442,"Ongoing","The Dannon Company, Inc.","Tarrytown","NY","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Product distributed to Arizona, California, Colorado, Idaho, Nevada, Oregon, Utah, and Washington. Including Govt/military/VA.","F-0129-2014","Class II","Dannon LIGHT & FIT Nonfat Yogurt - 4 PACK of 6 oz cups. Strawberry UPC 36632 02720.","Expiration code OCT 27 2013 WE",".","4512 cases","Dannon Company, Inc. is recalling Light n Fit Nonfat Yogurt because they may contain yeast.",9/27/2013,"09/27/2013",11/20/2013,"11/20/2013"
"Food",66442,"Ongoing","The Dannon Company, Inc.","Tarrytown","NY","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Product distributed to Arizona, California, Colorado, Idaho, Nevada, Oregon, Utah, and Washington. Including Govt/military/VA.","F-0130-2014","Class II","Dannon LIGHT & FIT Nonfat Yogurt - 4 PACK of 6 oz cups. Strawberry/Banana UPC 36632 02181.","Expiration code OCT 27 2013 WE",".","1942 cases","Dannon Company, Inc. is recalling Light n Fit Nonfat Yogurt because they may contain yeast.",9/27/2013,"09/27/2013",11/20/2013,"11/20/2013"
"Food",66443,"Ongoing","Grato Inc.","Woodbine","IA","US","Voluntary: Firm Initiated","Telephone","Distribution was nationwide through retail and internet sales. The distribution list is pending.","F-0164-2014","Class II","Apotheca Energique Gastrozyme, dietary supplement, 100 vegetarian capsules. ","Lot number C3354 The product mathmatical analysis of potential Chloramphenicol level is 1.07 ppb.",".","184/100-ct bottles","The products may contain chloramphenicol.",9/30/2013,"09/30/2013",11/20/2013,"11/20/2013"
"Devices",66444,"Ongoing","Stryker Instruments Div. of Stryker Corporation","Portage","MI","US","Voluntary: Firm Initiated","Letter","Worldwide distribution: US (nationwide) including states of: TX, FL, IL, IA, ND, WI, VA, and NJ.; and countries of: CANADA, POLAND and SWITZERLAND.","Z-0280-2014","Class II","Acetabular Pressurizer; single use and six units per box. The Acetabular Pressurizer 0206-522-000 is an accessory to the Advanced Cement Mixer (ACM). The Acetabular Pressurizer Tiplet P/N 0206-522-012 is sealed in a two pouches, sterilized, and labeled as part number 0206-522-000. This Acetabular Pressurizer is an accessory used to pressurize the cement applied to the prosthesis to be implanted during the surgery. The Acetabular Pressurizer is an injection molded component made with resin material DOW HDPD 10462N which is a rigid plastic once it is molded.","Part number: 0206-522-000 and lots: 08183012, 08310012, 09237012, 10243012, 11109012, 11353012, and 12216012",".","87 boxes (522 each)","On March 14, 2013 a Work Order was opened for 120 units (20 boxes) of the Acetabular Pressurizer (P/N 0206-522-000 Rev. H). On March 15, 2013, when the product was going to be placed in the pouch to be sealed, the manufacturing operator noticed that some assemblies were cracked. As a result of the injection pressure of the cement gun, a cracked tiplet may release from the Hub during cement application. There is also the potential for cement to leak out from the fissure in the tiplet during setting time, resulting in an inadequate supply of cement required to complete the surgery. ",11/1/2013,"11/01/2013",11/20/2013,"11/20/2013"
"Food",66445,"Ongoing","American Laboratories Inc","Omaha","NE","US","Voluntary: Firm Initiated","Telephone","Distribution was made to IA, UT, NV, NE and CA.","F-0093-2014","Class II","NUT 14-500, powder, plant enzyme blend, packaged in 15 kg and 23 kg double poly bags inside fiber box. Product 98A","15 KGS: Lot ALI13212-04; re-evaluation date 1/31/2015 and 23 KGS: Lot # ALI13036-01; re-evaluation date 8/5/2104. **Lot ALI13212-04 mathmatical analysis tested ''probably < 0.3 ppb in final product'' **Lot ALI13036-01 mathmatical analysis tested ''probably NOT < 0.3 ppb in final product''",,"1/23 KG-box and 2/15 KG-box","The products may be contaminated with Chloramphenicol.",9/30/2013,"09/30/2013",11/6/2013,"11/06/2013"
"Food",66445,"Ongoing","American Laboratories Inc","Omaha","NE","US","Voluntary: Firm Initiated","Telephone","Distribution was made to IA, UT, NV, NE and CA.","F-0092-2014","Class II","Xylanase 70,000XU/g, powder, enzyme, 100 gm. Product 71A","Lot ALI13206-06; re-evaluation date 1/25/2015 and Lot # ALI13008-13; re-evaluation date 7/8/2014 **sample only - not tested",,"2 sample bottles, 100 gm bottles","The products may be contaminated with Chloramphenicol.",9/30/2013,"09/30/2013",11/6/2013,"11/06/2013"
"Food",66445,"Ongoing","American Laboratories Inc","Omaha","NE","US","Voluntary: Firm Initiated","Telephone","Distribution was made to IA, UT, NV, NE and CA.","F-0096-2014","Class II","EB 110311-01, powder, enzyme blend, packaged in 5 kg double poly bags inside fiber box. Product 73C","Lot # ALI13200-09, re-evaluation date 1/19/2015; Lot # ALI13140-03, re-evaluation date 11/20/2014; Lot # ALI13071-01, re-evaluation date 9/12/2014 and Lot # ALI13008-01; re-evaluation date 7/8/2014. **Lot ALI13200-09 mathmatical analysis tested ''probably < 0.3 ppb in final product'' **the other three lots mathmatical analysis tested ''probably NOT < 0.3 ppb in final product''",,"4/5 KG-boxes","The products may be contaminated with Chloramphenicol.",9/30/2013,"09/30/2013",11/6/2013,"11/06/2013"
"Food",66445,"Ongoing","American Laboratories Inc","Omaha","NE","US","Voluntary: Firm Initiated","Telephone","Distribution was made to IA, UT, NV, NE and CA.","F-0094-2014","Class II","PC Blend 14, powder, enzyme blend, packaged in 9 kg and 25 kg double poly bags inside fiber box. Product 62A","9 KGS: Lot ALI13249-03; re-evaluation date 3/6/2015 and 25 KGS: Lot # ALI13024-02; re-evaluation date 7/24/2014. **Lots ALI13249-03 and ALI13024-02 mathmatical analysis tested ''probably < 0.3 ppb in final product'' **Lot ALI13036-01 mathmatical analysis tested ''probably NOT < 0.3 ppb in final product''",,"2/25 KG-boxes and 9.4 KG box","The products may be contaminated with Chloramphenicol.",9/30/2013,"09/30/2013",11/6/2013,"11/06/2013"
"Food",66445,"Ongoing","American Laboratories Inc","Omaha","NE","US","Voluntary: Firm Initiated","Telephone","Distribution was made to IA, UT, NV, NE and CA.","F-0089-2014","Class II","Pectinase 3,500 ENDO-PG/G, powder, enzyme, 100 gm. Product 70A","Lot ALI13157-09; re-evaluation date 12/6/2014. **sample only - not tested On 10/22/2013 American Laboratories provided CFSAN a customer distribution list for the Chloramphenicol Contamination. This spreadsheet listed the base concentrate levels. The data was highlighted: Green, Yellow, Red and Orange.The spreadsheet ",,"one sample bottle, 100 gm","The products may be contaminated with Chloramphenicol.",9/30/2013,"09/30/2013",11/6/2013,"11/06/2013"
"Food",66445,"Ongoing","American Laboratories Inc","Omaha","NE","US","Voluntary: Firm Initiated","Telephone","Distribution was made to IA, UT, NV, NE and CA.","F-0095-2014","Class II","Ultra Blend 102, powder, enzyme blend, packaged in 25 kg double poly bags inside fiber box. Product 73B, SI Item # 10678.","Lot # ALI13053-05; re-evaluation date 8/22/2104 **Lot ALI13053-05 mathmatical analysis tested ''VERY probable NOT < 0.3 ppb in final product''",,"1/25 KG-box","The products may be contaminated with Chloramphenicol.",9/30/2013,"09/30/2013",11/6/2013,"11/06/2013"
"Food",66445,"Ongoing","American Laboratories Inc","Omaha","NE","US","Voluntary: Firm Initiated","Telephone","Distribution was made to IA, UT, NV, NE and CA.","F-0091-2014","Class II","Xylanase 10,000XU/g, powder, enzyme, 100 gm. Product 45A","Lot ALI13206-05; re-evaluation date 1/25/2015 **sample only - not tested",,"1 sample bottle, 100 gm","The products may be contaminated with Chloramphenicol.",9/30/2013,"09/30/2013",11/6/2013,"11/06/2013"
"Food",66445,"Ongoing","American Laboratories Inc","Omaha","NE","US","Voluntary: Firm Initiated","Telephone","Distribution was made to IA, UT, NV, NE and CA.","F-0097-2014","Class II","EB 020812-01, powder, enzyme blend, packaged in 5 kg double poly bags inside fiber box. Product 77C","Lot # ALI13200-08, re-evaluation date 1/19/2015; Lot # ALI13140-02, re-evaluation date 11/20/2014; Lot # ALI13071-02, re-evaluation date 9/12/2014 and Lot # ALI13008-02; re-evaluation date 7/8/2014. **Lot ALI13200-08 mathmatical analysis tested ''probably < 0.3 ppb in final product'' **the other three lots mathmatical analysis tested ''probably NOT < 0.3 ppb in final product''",,"4/5 KG-boxes","The products may be contaminated with Chloramphenicol.",9/30/2013,"09/30/2013",11/6/2013,"11/06/2013"
"Food",66445,"Ongoing","American Laboratories Inc","Omaha","NE","US","Voluntary: Firm Initiated","Telephone","Distribution was made to IA, UT, NV, NE and CA.","F-0090-2014","Class II","Xylanase 150,000XU, powder, enzyme, 100 gm. Product 13A","Lot ALI13157-11; re-evaluation date 12/6/2014 **sample only - not tested",,"1 sample bottle, 100 gm","The products may be contaminated with Chloramphenicol.",9/30/2013,"09/30/2013",11/6/2013,"11/06/2013"
"Food",66445,"Ongoing","American Laboratories Inc","Omaha","NE","US","Voluntary: Firm Initiated","Telephone","Distribution was made to IA, UT, NV, NE and CA.","F-0090-2014","Class II","Xylanase 150,000XU, powder, enzyme, 100 gm. Product 13A","Lot ALI13157-11; re-evaluation date 12/6/2014 **sample only - not tested",".","1 sample bottle, 100 gm","The products may be contaminated with Chloramphenicol.",9/30/2013,"09/30/2013",11/13/2013,"11/13/2013"
"Food",66445,"Ongoing","American Laboratories Inc","Omaha","NE","US","Voluntary: Firm Initiated","Telephone","Distribution was made to IA, UT, NV, NE and CA.","F-0096-2014","Class II","EB 110311-01, powder, enzyme blend, packaged in 5 kg double poly bags inside fiber box. Product 73C","Lot # ALI13200-09, re-evaluation date 1/19/2015; Lot # ALI13140-03, re-evaluation date 11/20/2014; Lot # ALI13071-01, re-evaluation date 9/12/2014 and Lot # ALI13008-01; re-evaluation date 7/8/2014. **Lot ALI13200-09 mathmatical analysis tested ''probably < 0.3 ppb in final product'' **the other three lots mathmatical analysis tested ''probably NOT < 0.3 ppb in final product''",".","4/5 KG-boxes","The products may be contaminated with Chloramphenicol.",9/30/2013,"09/30/2013",11/13/2013,"11/13/2013"
"Food",66445,"Ongoing","American Laboratories Inc","Omaha","NE","US","Voluntary: Firm Initiated","Telephone","Distribution was made to IA, UT, NV, NE and CA.","F-0094-2014","Class II","PC Blend 14, powder, enzyme blend, packaged in 9 kg and 25 kg double poly bags inside fiber box. Product 62A","9 KGS: Lot ALI13249-03; re-evaluation date 3/6/2015 and 25 KGS: Lot # ALI13024-02; re-evaluation date 7/24/2014. **Lots ALI13249-03 and ALI13024-02 mathmatical analysis tested ''probably < 0.3 ppb in final product'' **Lot ALI13036-01 mathmatical analysis tested ''probably NOT < 0.3 ppb in final product''",".","2/25 KG-boxes and 9.4 KG box","The products may be contaminated with Chloramphenicol.",9/30/2013,"09/30/2013",11/13/2013,"11/13/2013"
"Food",66445,"Ongoing","American Laboratories Inc","Omaha","NE","US","Voluntary: Firm Initiated","Telephone","Distribution was made to IA, UT, NV, NE and CA.","F-0097-2014","Class II","EB 020812-01, powder, enzyme blend, packaged in 5 kg double poly bags inside fiber box. Product 77C","Lot # ALI13200-08, re-evaluation date 1/19/2015; Lot # ALI13140-02, re-evaluation date 11/20/2014; Lot # ALI13071-02, re-evaluation date 9/12/2014 and Lot # ALI13008-02; re-evaluation date 7/8/2014. **Lot ALI13200-08 mathmatical analysis tested ''probably < 0.3 ppb in final product'' **the other three lots mathmatical analysis tested ''probably NOT < 0.3 ppb in final product''",".","4/5 KG-boxes","The products may be contaminated with Chloramphenicol.",9/30/2013,"09/30/2013",11/13/2013,"11/13/2013"
"Food",66445,"Ongoing","American Laboratories Inc","Omaha","NE","US","Voluntary: Firm Initiated","Telephone","Distribution was made to IA, UT, NV, NE and CA.","F-0091-2014","Class II","Xylanase 10,000XU/g, powder, enzyme, 100 gm. Product 45A","Lot ALI13206-05; re-evaluation date 1/25/2015 **sample only - not tested",".","1 sample bottle, 100 gm","The products may be contaminated with Chloramphenicol.",9/30/2013,"09/30/2013",11/13/2013,"11/13/2013"
"Food",66445,"Ongoing","American Laboratories Inc","Omaha","NE","US","Voluntary: Firm Initiated","Telephone","Distribution was made to IA, UT, NV, NE and CA.","F-0089-2014","Class II","Pectinase 3,500 ENDO-PG/G, powder, enzyme, 100 gm. Product 70A","Lot ALI13157-09; re-evaluation date 12/6/2014. **sample only - not tested On 10/22/2013 American Laboratories provided CFSAN a customer distribution list for the Chloramphenicol Contamination. This spreadsheet listed the base concentrate levels. The data was highlighted: Green, Yellow, Red and Orange.The spreadsheet ",".","one sample bottle, 100 gm","The products may be contaminated with Chloramphenicol.",9/30/2013,"09/30/2013",11/13/2013,"11/13/2013"
"Food",66445,"Ongoing","American Laboratories Inc","Omaha","NE","US","Voluntary: Firm Initiated","Telephone","Distribution was made to IA, UT, NV, NE and CA.","F-0093-2014","Class II","NUT 14-500, powder, plant enzyme blend, packaged in 15 kg and 23 kg double poly bags inside fiber box. Product 98A","15 KGS: Lot ALI13212-04; re-evaluation date 1/31/2015 and 23 KGS: Lot # ALI13036-01; re-evaluation date 8/5/2104. **Lot ALI13212-04 mathmatical analysis tested ''probably < 0.3 ppb in final product'' **Lot ALI13036-01 mathmatical analysis tested ''probably NOT < 0.3 ppb in final product''",".","1/23 KG-box and 2/15 KG-box","The products may be contaminated with Chloramphenicol.",9/30/2013,"09/30/2013",11/13/2013,"11/13/2013"
"Food",66445,"Ongoing","American Laboratories Inc","Omaha","NE","US","Voluntary: Firm Initiated","Telephone","Distribution was made to IA, UT, NV, NE and CA.","F-0095-2014","Class II","Ultra Blend 102, powder, enzyme blend, packaged in 25 kg double poly bags inside fiber box. Product 73B, SI Item # 10678.","Lot # ALI13053-05; re-evaluation date 8/22/2104 **Lot ALI13053-05 mathmatical analysis tested ''VERY probable NOT < 0.3 ppb in final product''",".","1/25 KG-box","The products may be contaminated with Chloramphenicol.",9/30/2013,"09/30/2013",11/13/2013,"11/13/2013"
"Food",66445,"Ongoing","American Laboratories Inc","Omaha","NE","US","Voluntary: Firm Initiated","Telephone","Distribution was made to IA, UT, NV, NE and CA.","F-0092-2014","Class II","Xylanase 70,000XU/g, powder, enzyme, 100 gm. Product 71A","Lot ALI13206-06; re-evaluation date 1/25/2015 and Lot # ALI13008-13; re-evaluation date 7/8/2014 **sample only - not tested",".","2 sample bottles, 100 gm bottles","The products may be contaminated with Chloramphenicol.",9/30/2013,"09/30/2013",11/13/2013,"11/13/2013"
"Food",66446,"Ongoing","Vitalab Co Inc","North Kansas City","MO","US","Voluntary: Firm Initiated","Letter","Distribution was made both retail and wholesale to AZ, CA, CO, FL, GA, IA, IL, KS, KY, LA, MD, MI, MN, NJ, MN, MO, NC, NE, NH, NY, OH, OR, PA, TX, WA and WI. Distribution was made to PR.","F-0101-2014","Class II","VIT-RA-TOX Whole Beet Plant Juice, dietary supplement, dry, 400 mg tablet, packaged in 150 tablets glass, amber bottles. No. 48. National Distributors: V.E. Irons, Inc, N. Kansas City, MO. Springreen Whole Beet Plant Juice, dietary supplement, dry, 400 mg tablet, packaged in 150 tablets glass, amber bottles. No. 88. National Distributors: Springreen Products, Inc, N. Kansas City, MO. Sonne's Whole Beet Plant Juice, dietary supplement, dry, 400 mg tablet, packaged in 150 tablets glass, amber bottles. No. 18. National Distributors: Sonne's Organic Foods, Inc., N. Kansas City, MO ","All three labels have the same lot code: 06-11-15-2",".","280 bottles","The firm reports a customer found a foreign object in the product.",10/4/2013,"10/04/2013",11/13/2013,"11/13/2013"
"Drugs",66447,"Ongoing","West-Ward Pharmaceutical Corp.","Eatontown","NJ","US","Voluntary: Firm Initiated","Letter","Nationwide","D-66447-001","Class II","Irinotecan Hydrochloride Injection, 40 mg/2 mL (20 mg/mL), 1 x 2 mL Single Dose Vial per carton, Rx only, Manufactured by: Thymoorgan Pharmazie GmbH, Schiffgraben 23, 38690 Vienenburg, Germany; Distributed by: West-Ward Pharmaceutical Corp., Eatontown, NJ 07724 USA, NDC 0143-9702-01.","Lot #: AC0020, Exp 03/14; AC0023, AC0025, Exp 08/14 ",".","9020 vials","Superpotent Drug: a recent review of the USP revealed that an incorrect calculation was used to determine the amount of irinotecan to use in formulation which will result in an assay higher than the labeled claim.",9/23/2013,"09/23/2013",11/13/2013,"11/13/2013"
"Drugs",66447,"Ongoing","West-Ward Pharmaceutical Corp.","Eatontown","NJ","US","Voluntary: Firm Initiated","Letter","Nationwide","D-66447-002","Class II","Irinotecan Hydrochloride Injection, 100 mg/5 mL (20 mg/mL), 1 x 5 mL Single Dose Vial per carton, Rx only, Manufactured by: Thymoorgan Pharmazie GmbH, Schiffgraben 23, 38690 Vienenburg, Germany; Distributed by: West-Ward Pharmaceutical Corp., Eatontown, NJ 07724 USA, NDC 0143-9701-01.","Lot #: AC0026, AC0027, Exp 10/14 ",".","9813 vials","Superpotent Drug: a recent review of the USP revealed that an incorrect calculation was used to determine the amount of irinotecan to use in formulation which will result in an assay higher than the labeled claim.",9/23/2013,"09/23/2013",11/13/2013,"11/13/2013"
"Devices",66449,"Ongoing","Integra LifeSciences Corp.","Plainsboro","NJ","US","Voluntary: Firm Initiated","Letter","US Distribution including the states of AL, AR, CA, CT, FL, GA, IA, IL, MS, NY, OH, SC, TN, and TX.","Z-0210-2014","Class II","Composite Series Skull Clamp, one clamp per tote. The MAYFIELD Skull Clamp (A3059) is a cranial stabilization device, designed to provide rigid skeletal fixation. The Skull Clamp is placed on the patient's skull to hold their head and neck securely in a particular position when rigid fixation is desired. The clamp is indicated for use in open and percutaneous craniotomies as well as spinal surgery when rigid skeletal fixation is necessary","The following serial numbers are affected by this recall: SS120076, SS120082, SS120083, SS120084, SS120088, SS120089, SS120090, SS120092, SS120093, SS120094, SS120095, SS120111, SS120112, SS120113, SS120114, SS120115, SS120116, SS120117, SS120118, SS120119, SS120120, SS120121, SS120122, SS120123, SS120124, SS120125, SS120126, SS120127, SS120128, SS120130, SS120131, SS120133, SS120134, SS120135, SS120171, SS120252, SS120256, SS120257",".","37 units","An investigation of an adverse trend of complaints for the Skull Clamp index locking knob not easily unlocking or disengaging and malfunctions of the 80 lbs. torque knob was initiated. None of the complaints resulted in a report of patient injury, adverse health consequence, or a delay / prolongation of the surgical procedure.",8/29/2013,"08/29/2013",11/20/2013,"11/20/2013"
"Devices",66450,"Ongoing","OrthoPediatrics Corp","Warsaw","IN","US","Voluntary: Firm Initiated","E-Mail","Worldwide Distribution - US including Michigan and the countries of Ireland and Australia","Z-0276-2014","Class II","3.5MM LOCKING SCREW, T15 HEXALOBE, SELF TAPPING, 34MM The OrthoPediatrics Proximal Femur Plating System combines implants and instruments in one convenient system. This system offers the advantages of the osteotomy blade plates and cannulated instrumentation. Osteotomy plates provide ease of reduction and good rotational stability while maintaining bone stock. Cannulated instruments work over a guide wire for precise placement and safety. The subject device is a Bone Screw designed for use with this system.","Part Number:. 00-0903-2634 and lot number 009U2",".","7 units shipped","The firm identified, through complaints that the 3.5MM LOCKING SCREW packaging material was marked as a 3.5mm screw and the part number was correct but that the description indicated a 7.0mm screw. Upon investigation, it has been determined that a lot number 009U2 was packaged and mislabeled internally by OrthoPediatrics.",9/26/2013,"09/26/2013",11/20/2013,"11/20/2013"
"Drugs",66451,"Ongoing","American Health Packaging","Columbus","OH","US","Voluntary: Firm Initiated","Letter","Nationwide","D-323-2014","Class II","Valacyclovir HCl Tablets, 500 mg, 100 tablets (10x10) blister cards, Rx only, Packaged and Distributed by: American Health Packaging, Columbus, OH NDC 68084-633-01","The following product was affected: AHP Lot #: 130007 Expiration Date: 01/31/2014 Carton NDC #: 68084-633-01 Single Dose NDC #: 68084-633-11",".","1536 cartons","Subpotent",8/2/2013,"08/02/2013",12/11/2013,"12/11/2013"
"Food",66452,"Ongoing","D. F. Stauffer Biscuit Co, Inc.","York","PA","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Product was distributed directly to one distributor (McLane) who then further distributed to Target department stores located nationwide.","F-0729-2014","Class I","Market Pantry brand Animal Cookies, white fudge coated, in a clear plastic bear-shaped jar, net wt. 44 oz. Ingredients: enriched flour (wheat flour, malted barley flour, niacin, reduced iron, thiamin mononitrate, riboflavin, folic acid), sugar, soybean oil, high fructose corn syrup, invert sugar, cocoa (processed with alkali), graham flour, chocolate, salt, baking soda, calcium carbonate, soy lecithin, natural and artificial flavor, color with (caramel color, blue 1, yellow 6), preservatives (sodium benzoate, potassium sorbate, sodium metabisulfite), spices (mace and nutmeg). Contains wheat and soy. May contain peanuts and tree nuts. Distributed by Target Corporation, Minneapolis, MN.","UPC 0 85239 08259 1 Lot Number Best By Y072913B 29APR2014 Y072913C 29APR2014 Y073013A 30APR2014 Y073013B 30APR2014 Y073013C 30APR2014 Y073113A 01MAY2014 Y082113A 21MAY2014 Y082113B 21MAY2014 Y082113C 21MAY2014 Y082213A 22MAY2014 Y082913A 29MAY2014 Y082913B 29MAY2014 Y082913C 29MAY2014 Y083013A 30MAY2014 Y083013B 30MAY2014 Y090313B 03JUN2014 Y090313C 03JUN2014 Y090413A 04JUN2014 Y090413B 04JUN2014 Y090413C 04JUN2014 ",".","20, 075 case (6 units per case)","undeclared milk and egg in Market Pantry brand white fudge coated Animal Cookies",10/3/2013,"10/03/2013",12/11/2013,"12/11/2013"
"Food",66453,"Terminated","Orange County Produce","Irvine","CA","US","Voluntary: Firm Initiated","Press Release","CA","F-0084-2014","Class I","Red and Green Bell Peppers, 25 lbs.","Lot # SB 7 920, SB 7 923, SB 7 924 ",,"1208 units","Orange County Produce, LLC is recalling fresh red and green Bell Peppers because they may have the potential to be contaminated with Salmonella. ",10/6/2013,"10/06/2013",11/6/2013,"11/06/2013"
"Devices",66456,"Ongoing","Stryker Instruments Div. of Stryker Corporation","Portage","MI","US","Voluntary: Firm Initiated","Letter","Nationwide Distribution including the states of AR, AZ, CA, CO, FL, GA, IL, KS, MS, ND, and NE.","Z-0127-2014","Class II","Dekompressor Percutaneous Discectomy Probe. The Dekompressor is a single use disposable discectomy probe that passes through and works in conjunction with an introducer cannula to remove intervertebral disc nucleus pulposus material.","Part Number(s) 0407-251-000, 0407-260-000, 0407-265-000, 0407-266-000, 0407-280-000, and 0407-281-000.",".","20,385 total distributed since 2004","Stryker has identified a potential for the auger and/or cannula to fracture when the Dekompressor is used contrary to the warnings in the Instructions For Use (IFU). Specifically, manually bending the cannula can weaken the device and may result in a fracture of the auger and/or cannula. This could result in the need for additional medical intervention to remove the broken piece, pain or loss of mobility. There have been no deaths or serious adverse events.",11/4/2013,"11/04/2013",11/13/2013,"11/13/2013"
"Devices",66457,"Ongoing","Richard Wolf Medical Instruments Corp.","Vernon Hills","IL","US","Voluntary: Firm Initiated","Letter","Nationwide distribution: US including states of: CA, GA, IL, KY, LA, MI, MD, NY, OR, TX, VA and Puerto Rico.","Z-0145-2014","Class II","Individual units labeled in part: REF: 4630022; for S(a)line resectoscopes; Vaporization electrode, sterite; 4mm telescope 30 25 / 12: only for continuous irrigation sheath 24,5 Fr.; LOT 426111; 2011/06; 2016/06; STERILE; RICHARD WOLF; Cartons of 3 units labeled in part: REF 46300223; Vaporization electrode, sterile; 4mm telescope 30/25/12; only for continuous irrigation sheath 24,5 Fr.; Lot 426111; 2011/06; 2016/06; STERILE; RICHARD WOLF S(a)line Resectoscopes are used for endoscopically controlled removal (ablation) of tissue using 0.9% NaCl solution (saline) as the irrigation medium. It can also be used for monopolar resection if necessary.","*** Individual Units *** Product Code: 4630022; Lot: 426111; Expiration Date: 2016/06; *** Cartons *** Product Code: 4630023; Lot: 426111; Expiration Date: 2016/06; ",".","87 cartons (261 units)","Richard Wolf Medical Instrument Corporation recieved a complaint stating that a 4630024 vaporization electrode was packaged in a 4630022 pouch.",9/16/2013,"09/16/2013",11/13/2013,"11/13/2013"
"Drugs",66458,"Ongoing","Sandoz, Inc","Princeton","NJ","US","Voluntary: Firm Initiated","Letter","Nationwide","D-66458-1","Class II","Ropinirole, extended-release tablets, 2 mg, 90 count bottle, Rx only, Manufactured in India by Sandoz Private Ltd, for Sandoz Inc, Princeton, NJ 08540, NDC 0781-5780-92","Lot DJ2744, Exp 12/2014",".","692 bottles (90 count)","Cross contamination with other products: Sandoz is recalling certain lots of Ropinirole Extended Release Tablets 2 mg due to the potential presence of carryover coming from the previously manufactured product, mycophenolate mofetil.",10/9/2013,"10/09/2013",11/13/2013,"11/13/2013"
"Devices",66459,"Ongoing","GE Healthcare, LLC","Waukesha","WI","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution-USA (nationwide) and the countries of Algeria, Argentina, Australia, Austria, Belarus, Belgium, Canada, Chile, Colombia, Croatia, Czech Republic, Denmark, Finland, France, Germany, Greece, Hong Kong, India, Indonesia, Italy, Japan, Korea (Republic of), Kuwait, Latvia, Lebanon, Libyan Arab Jamahiriya, Malaysia, Netherlands, Norway, Oman, Peru, Philippines, Poland, Portugal, Qatar, Romania, Russia, Saudi Arabia, Serbia, Singapore, South Africa, Spain, Sweden, Switzerland, Taiwan, Thailand, Turkey, United Arab Emirates, and United Kingdom.","Z-0373-2014","Class II","GE Vivid E9 ultrasound system. GE Vivid E9 is a Track 3 diagnostic ultrasound system, which is primarily intended for cardiac imaging and analysis, but which also includes vascular and general radiology applications. The Vivid E9 incorporates a variety of electronic array transducers operating in linear, curved linear, sector/phased array or matrix array format, including two dedicated CW transducers and several real time 3D transducers. It consists of a mobile console with keyboard control panel; color LCD/TFT touch panel, LCD color video display and optional image storage and printing devices. It provides high performance ultrasound imaging and analysis and has comprehensive networking and DICOM capability.","Serial numbers: 0000000VE94166, 0000000VE94167, 0000000VE94170, 0000000VE94171, 0000000VE94172, 0000000VE94173, 0000000VE94174, 0000000VE94175, 0000000VE94176, 0000000VE94177, 0000000VE94178, 0000000VE94179, 0000000VE94180, 0000000VE94181, 0000000VE94182, 0000000VE94183, 0000000VE94184, 0000000VE94185, 0000000VE94186, 0000000VE94187, 0000000VE94188, 0000000VE94190, 0000000VE94191, 0000000VE94192, 0000000VE94193, 0000000VE94194, 0000000VE94195, 0000000VE94196, 0000000VE94197, 0000000VE94198, 0000000VE94199, 0000000VE94210, 0000000VE94211, 0000000VE94212, 0000000VE94213, 0000000VE94214, 0000000VE94215, 0000000VE94216, 0000000VE94217, 0000000VE94225, 0000000VE94226, 0000000VE94227, 0000000VE94231, 0000000VE94232, 0000000VE94233, 0000000VE94234, 0000000VE94235, 0000000VE94236, 0000000VE94237, 0000000VE94238, 0000000VE94243, 0000000VE94244, 0000000VE94245, 0000000VE94246, 0000000VE94247, 0000000VE94248, 0000000VE94249, 0000000VE94250, 0000000VE94251, 0000000VE94252, 0000000VE94253, 0000000VE94254, 0000000VE94263, 0000000VE94268, 0000000VE94270, 0000000VE94280, 0000000VE94281, 0000000VE94285, 0000000VE94286, 0000000VE94287, 0000000VE94288, 0000000VE94289, 0000000VE94290, 0000000VE94291, 0000000VE94292, 0000000VE94293, 0000000VE94294, 0000000VE94295, 0000000VE94296, 0000000VE94297, 0000000VE94299, 0000000VE94300, 0000000VE94301, 0000000VE94302, 0000000VE94303, 0000000VE94305, 0000000VE94306, 0000000VE94307, 0000000VE94314, 0000000VE94315, 0000000VE94316, 0000000VE94317, 0000000VE94318, 0000000VE94319, 0000000VE94327, 0000000VE94328, 0000000VE94329, 0000000VE94330, 0000000VE94331, 0000000VE94332, 0000000VE94333, 0000000VE94334, 0000000VE94340, 0000000VE94349, 0000000VE94350, 0000000VE94351, 0000000VE94353, 0000000VE94354, 0000000VE94355, 0000000VE94356, 0000000VE94357, 0000000VE94358, 0000000VE94359, 0000000VE94361, 0000000VE94362, 0000000VE94363, 0000000VE94364, 0000000VE94365, 0000000VE94366, 0000000VE94367, 0000000VE94368, 0000000VE94372, 0000000VE94373, 0000000VE94374, 0000000VE94375, 0000000VE94377, 0000000VE9437",,"710","GE became aware of a potential safety issue due to a system slow down and system lock up associated with the software of Vivid E9 ultrasound system. During a critical procedure the Vivid E9 Scanner may gradually become unresponsive and eventually lock up, with the result that the vivid E9 Scanner must be rebooted. ",10/11/2013,"10/11/2013",11/27/2013,"11/27/2013"
"Veterinary",66460,"Ongoing","Lloyd Inc. of Iowa","Shenandoah","IA","US","Voluntary: Firm Initiated","Letter","Distribution was made in the US to AL, AZ, CA, CO, FL, GA, HI ,IA, ID, IN KS, MI, MN, MO, MS, NC, NY, PA, TX, VA, WA and WI. No foreign distribution was made.","V-010-2014","Class III","Lloyd Butorphic Injection, Butorphanol Tartrate, 10 mg/mL, 20 mL, C 4, ANDA 200-332. Manufactured by Akorn, Inc., Decatur, IL for Lloyd, Shenandoah, IA.","Lot LA28410A and Lot LA29810A",".","4,466 vials","The product is being recalled because of an incorrect expiration date listed on the product label.",10/3/2013,"10/03/2013",12/11/2013,"12/11/2013"
"Devices",66461,"Ongoing","Invacare Corporation","Elyria","OH","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution - USA including PA and Internationally to Canada.","Z-0167-2014","Class II","Aquatec Ocean VIP, Aquatec Ocean Dual-VIP, Aquatec Ocean E-VIP mobile shower and toilet commode with tilting function. Mobile shower and toilet commode with tilting function","The following model and serial numbers were affected by this recall: Aquatec Ocean VIP Model number: 1470793 Serial numbers: 14541797; 14541800; 14541803; 14541804; 14541805; 14541806; 14541807; 14541808; 14541809; 14541810; 14541812; 14541820; 14541821; 14541822; 14541823; 14541825; 14541836; 14541837; 14541838; 14541839; 14541841; 14541842; 14541886; 14541918; 14541931; 14541937; 14541940; 14541941; 14541942; 14541944; 14541967; 14542408; 14542416; 14542418; 14542424; 14542435; 14542436; 14542437; 14542450; 14542451; 14542460; 14542462; 14542464; 14542468; 14542469; 14542472; 14542613; 14542614; 14542616; 14542652; 14542688; 14542689; 14542692; 14542693; 14542694; 14542695; 14542696; 14542700; 14542705; 14542712; 14542713; 14542714; 14542725; 14542734; 14542737; 14542738; 14542739; 14542750; 14542878; 14542879; 14542880; 14542885; 14542960; 14542967; 14542969; 14542970; 14543048; 14543050; 14543053; 14543055; 14543059; 14543064; 14543068; 14543077; 14543086; 14543087; 14543089; 14543090; 14543091; 14543092; 14543093; 14543094; 14543095; 14543096; 14543097; 14543101; 14543106; 14543107; 14543110; 14543111; 14543112; 14543113; 14543114; 14543115; 14543117; 14543118; 14543122; 14543124; 14543125; 14543126; 14543128; 14543129; 14543130; 14543131; 14543132; 14543133; 14543134; 14543136; 14543138; 14543139; 14543144; 14543147; 14543150; 14543151; 14543155; 14543156; 14543159; 14543160; 14543164; 14543165; 14543168; 14543171; 14543172; 14543173; 14543176; 14543177; 14543178; 14543180; 14543181; 14543182; 14543183; 14543185; 14543187; 14543191; 14543192; 14543193; 14543196; 14543199; 14545700; 14545701; 14545704; 14545706; 14545708; 14545709; 14545710; 14545711; 14545713; 14545715; 14545716; 14545717; 14545718; 14545719; 14545720; 14545721; 14545722; 14545723; 14545724;14545725; 14545727; 14545730; 14545731; 14545732; 14545733; 14545734; 14545735; 14545736; 14545737; 14545738; 14545739; 14545740; 14545741; 14545742; 14545743; 14545744; 14545745; 14545746; 14545747; 14546178; 14546179; 14546180; 14546181; 14546182; 1",".","538 (US only) 3317 (Total) ","The snap-on fixtures of the backrest cushion on the Mobile Shower and Toilet Commode Aquatec Ocean VIP and Ocean Dual VIP do not withstand a required pull out force of 500 N, when the product is used in a reclined position and or tilted position. This may result in the snap-on fixture coming unlatched.",8/31/2013,"08/31/2013",11/13/2013,"11/13/2013"
"Drugs",66462,"Ongoing","Nephron Pharmaceuticals Corp.","Orlando","FL","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Nationwide and Puerto Rico","D-66462-001","Class II","Albuterol Sulfate Inhalation Solution, 0.083% 2.5 mg/3 mL for Oral Inhalation Only, Rx Only, 25 x 3 mL Sterile Unit-Dose Vials per carton, Manufactured By: Nephron Pharmaceuticals Corporation, Orlando, FL 32811, NDC 0487-9501-25","Lots #: A3A33A, A3A33B, A3A34A, A3A35A. A3A36A, A3A37A, A3A38A, Exp 06/15; A3A40A, A3A41A, A3A42A, Exp 07/15",".","689,568 cartons","Lack of Assurance of Sterility: Nephron Pharmaceuticals Corporation conducted a routine periodic aseptic process simulation and discovered bacterial growth in a number of media fill vials, exceeding the allowable limit.",10/2/2013,"10/02/2013",10/30/2013,"10/30/2013"
"Food",66463,"Ongoing","Epicure Food Corp.","Elizabeth","NJ","US","Voluntary: Firm Initiated","Telephone","CT, DC, DE, MD, NJ, NY & PA","F-0088-2014","Class I","St. Marcellin Au lait pasteurise fabrique en Dauphine l'unite: poids net 80ge Fromagerie Qurtet 38470 VINAY ","Lot #13U219, Lot # 13U225",,"20 cases (8-80 gm units per case)","The French Ministry of Food, Agriculture is requiring cheese to be withdrawn from sales at all levels of distribution as L. monocytogenes was detected in thermised (heat-treated/not pasteurized) product in France which was not exported.",9/12/2013,"09/12/2013",11/6/2013,"11/06/2013"
"Devices",66464,"Ongoing","Sorin Group Deutschland GmbH","Munchen",,"DE","Voluntary: Firm Initiated","Letter","Worldwide Distribution - USA including WA, NY, VA, TN, SC, TX, CA, CO, MA, WI, MD, AL, ND, and Puerto Rico and Internationally to Italy, Finland, Germany, Sweden, and Great Britain.","Z-0142-2014","Class II","S5 Heart-lung machine, Stockert S5 System. Catalogue No: 48-30/40/50-00. The Stockert S5 System is intended to be used during cardiopulmonary bypass for procedures lasting six(6) hours or less.","Serial Numbers: 48E00235,48E00339,48E00342,48E01753,48E02767,48E02753,48E02745,48E02746,48E02748,48E02416,48E01033,480E1038,48E01040,48E01041,48E01043,48E01044,48E01051,48E02631,48E01183,48E02758,48E02764,48E01832,48E01834,48E02278,48E02722,48E02732,48E02326,48E02797,48E02793,48E02791,48E02781,48E02785,48E02786,48E02783,48E02772,48E02802,48E02778,48E02784,48E02788,48E02789,48E02779,48E02792,48E02790,48E02771,48E02773,48E02776,48E02799,48E02801",".","84","Sorin Group is recalling certain models of S5 Perfusion Systems due to malfunction of cardioplegia control.",9/24/2013,"09/24/2013",11/13/2013,"11/13/2013"
"Devices",66465,"Ongoing","Ethicon Endo-Surgery Inc","Cincinnati","OH","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution in the states of: Alabama, Connecticut, Indiana, Michigan, North Carolina, South Carolina, Alaska, Delaware, Kansas, Minnesota, Ohio, Tennessee, Arizona, Florida, Kentucky, Mississipp,i Oklahoma, Texas, Arkansas, Georgia, Louisiana, Nebraska, Oregon, Virginia, California, Idaho, Maryland, Nevada, Pennsylvania, Washington, Colorado, Illinois, Massachusetts, New Jersey, Rhode Island, and West Virginia. and the countries of: Argentina, France, Malaysia, Spain, Australia, Georgia, Martinique, Sweden, Belgium, Germany, Mexico, Switzerland, Brazil, Greece, Netherland, Taiwan, Chile, Hungary, Panama, Tunisia, China, India, Philippines, United Arab Emirates, Czech Republic, Israel, Poland, United Kingdom, Egypt, Italy, Portugal, Venezuela, Estonia, Kenya, Russia, Finland, Kuwait, and Saudi Arabia. In addition to the products listed in the Quantity Distributed section above, 1,363 RLZB22 gastric bands in convenience kits were also distributed as follows, according to Band Pak Codes: RLZB22D1 - 968 kits, RLZB22DG1 - 327 kits, RLZB22DGT - 20 kits, and RLZB22DT - 48 kits.","Z-0150-2014","Class II","Adjustable Gastric Band, packaged alone in transparent PETG inner and outer blisters with Tyvek lids. Product Usage: Intended for use in surgical treatment of morbid obesity ","The following product code and lot numbers were affected by this recall: Product Codes: 2200-X Lot Numbers: ZLGBC5, ZLNBCW, ZLNBJC, ZLPBB9, ZMBBBB, ZMCBBC, ZMGBCJ, ZMHBBT, ZMHBCV, ZMLBD0, ZMMBCD, ZMPBBC, ZNCBC6, ZNGBB3, and ZNGBBF. ",".","Product Code: 2200-X - 2,475 units","During aging studies, the firm determined that the gastric belts were unable to pass the test requirements established for Force to Lock. ",9/30/2013,"09/30/2013",11/13/2013,"11/13/2013"
"Devices",66465,"Ongoing","Ethicon Endo-Surgery Inc","Cincinnati","OH","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution in the states of: Alabama, Connecticut, Indiana, Michigan, North Carolina, South Carolina, Alaska, Delaware, Kansas, Minnesota, Ohio, Tennessee, Arizona, Florida, Kentucky, Mississipp,i Oklahoma, Texas, Arkansas, Georgia, Louisiana, Nebraska, Oregon, Virginia, California, Idaho, Maryland, Nevada, Pennsylvania, Washington, Colorado, Illinois, Massachusetts, New Jersey, Rhode Island, and West Virginia. and the countries of: Argentina, France, Malaysia, Spain, Australia, Georgia, Martinique, Sweden, Belgium, Germany, Mexico, Switzerland, Brazil, Greece, Netherland, Taiwan, Chile, Hungary, Panama, Tunisia, China, India, Philippines, United Arab Emirates, Czech Republic, Israel, Poland, United Kingdom, Egypt, Italy, Portugal, Venezuela, Estonia, Kenya, Russia, Finland, Kuwait, and Saudi Arabia.","Z-0151-2014","Class II","Adjustable Gastric Band, packaged alone in transparent PETG inner and outer blisters with Tyvek lids. Product Usage: Intended for use in surgical treatment of morbid obesity ","The following product code and lot numbers were affected by this recall: Product Codes: BD2XV Lot Numbers: ZJMBB4, ZJMBN9, ZJNBBV, ZKDBM6, ZKDBM7, ZKFBDC, ZKGBDY, ZKHBBJ, ZKHBCR, ZKHBFG, ZKNBCK, ZKNBHC, ZLBBFK, ZLDBB8, ZLFBBC, ZLFBGG, ZLGBFV, ZLGBG5 , ZLJBCL, ZLMBBD, ZLMBYF, ZLNBCH, ZMBBGJ, ZMCBDL, ZMFBCT, ZMGBDF, ZMKBCG, ZNBBBB, and ZNCBBB.",".","Product Code: BD2XV - 1,248 units","During aging studies, the firm determined that the gastric belts were unable to pass the test requirements established for Force to Lock. ",9/30/2013,"09/30/2013",11/13/2013,"11/13/2013"
"Devices",66465,"Ongoing","Ethicon Endo-Surgery Inc","Cincinnati","OH","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution in the states of: Alabama, Connecticut, Indiana, Michigan, North Carolina, South Carolina, Alaska, Delaware, Kansas, Minnesota, Ohio, Tennessee, Arizona, Florida, Kentucky, Mississipp,i Oklahoma, Texas, Arkansas, Georgia, Louisiana, Nebraska, Oregon, Virginia, California, Idaho, Maryland, Nevada, Pennsylvania, Washington, Colorado, Illinois, Massachusetts, New Jersey, Rhode Island, and West Virginia. and the countries of: Argentina, France, Malaysia, Spain, Australia, Georgia, Martinique, Sweden, Belgium, Germany, Mexico, Switzerland, Brazil, Greece, Netherland, Taiwan, Chile, Hungary, Panama, Tunisia, China, India, Philippines, United Arab Emirates, Czech Republic, Israel, Poland, United Kingdom, Egypt, Italy, Portugal, Venezuela, Estonia, Kenya, Russia, Finland, Kuwait, and Saudi Arabia.","Z-0149-2014","Class II","Adjustable Gastric Band, packaged alone in transparent PETG inner and outer blisters with Tyvek lids, or in various kit configurations with one band per kit. Product Usage: Intended for use in surgical treatment of morbid obesity ","The following product code and lot numbers were affected by this recall: Product Codes: RLZB22 Lot Numbers: ZJKBK6, ZJLBBR, ZJLBBT, ZJLBBV, ZJMBB5, ZJMBCG, ZJMBCH, ZJMBCJ, ZJMBCK, ZJMBCL, ZJMBJC, ZJMBJD, ZJMBJF, ZJPBD1, ZJPBD2, ZJPBFT, ZJPBFV, ZKBBCC, ZKBBCD, ZKBBCF, ZKBBCG, ZKBBGC, ZKBBGD, ZKBBGJ, ZKBBJN, ZKBBNV, ZKBBNW, ZKBBNY, ZKCBBK, ZKCBDD, ZKCBJJ, ZKMBK4, ZKMBKP, ZKNBBB, ZKNBCL, ZLBBCH, ZLBBFJ, ZLBBFL, ZLCBCB, ZLCBD8, ZLDBCZ, ZLDBDM, ZLDBDV, ZLFBF7, ZLFBFB, ZLLBCR, ZLLBFT, ZLMBCH, ZLMBWD, ZLNBBF, ZLNBGZ, ZMCBDH, ZMDBCH, ZMFBC4, ZMGBBF, ZMGBC1, ZMHBBW, ZMJBHV, ZMKBBH, ZMLBCJ, ZMNBCK, ZNBBD2, ZNFBCC, ZNHBCM, and ZNLBB4. Product Codes: RLZB22D1 Lot Numbers: G4TA93, G4TC3R, G4TD5R, G4TF1X, G4TG22, G4TK21, G4TL1D, G4TM3L, G4TM84, G4TP0W, G4TT4D, G4TU2V, G4TV3T, G4TW6D, G4U17U, G4U75W, G4U795, G4UD6T, G4UF6Y, G4UG4E, G4UH49, G4UH4K, H43A3N, H43C8P, H43E9V, H43J2P, H43N12, H43N42, H43P5U, H43P9C, H43T3F, H43U78, H43V8J, H43X4K, H43Z8Y, H4453N, H44623, H4478W, H44965, H44C9G, H44D8W, H44K3G, H44K9M, H44N0X, H44R1Y, H44R4U, H44T9D, H44V39, H44W6H, H44Y24, H44Z0Y, J4A04D, J4A11V, J4A274, J4A668, J4A81X, J4A96M, J4AC6L, J4AE3P, J4AH2Z, J4AK89, J4AN34, J4AU9R, J4AW1Y, J4C35K, J4C76E, J4CE9V, K4C518, K4CE4L, K4CT8W, K4D17T, and K4D45Y. Product Codes: RLZB22DG1 Lot Numbers: G4TH90, G4TJ61, G4TP6J, G4TR76, G4TV48, G4TX1V, G4U184, G4U734, G4UD77, G4UF9V, G4UH6P, H43A3P, H43C8R, H43G7Y, H43T3K, H43U7E, H43X1G, H43Z5Y, H44645, H44H9M, H44K2T, H44L44, H44V3A, H44W6G, H44Y25, H44Z0X, H44Z3N, J4A48K, J4AA11, J4AL00, J4AR9K, and K4CE6X . Product Codes: RLZB22DGT Lot Numbers: G4U323, J4AY55, and K4C663. Product Codes: RLZB22DT Lot Numbers: G4UD92, H44D1Y, J4AY72, and K4C666. Product Codes: RLZB22T Lot Numbers: G4RE82 ",".","Product codes: RLZB22 - 2,352 units; RLZB22D1 - 968 units; RLZB22DG1 - 327 units; RLZB22DGT - 20 units; RLZB22DT - 48 units; RLZB22T - 0 units","During aging studies, the firm determined that the gastric belts were unable to pass the test requirements established for Force to Lock. ",9/30/2013,"09/30/2013",11/13/2013,"11/13/2013"
"Food",66466,"Ongoing","Krispak Inc","Grand Rapids","MI","US","Voluntary: Firm Initiated","Telephone","Michigan and Ohio","F-0182-2014","Class II","Good Sense Spicy Sweet Mix, 25-oz (1lb 9oz) plastic container, UPC: 030243787178","Lot 09/06/14",,"315 cases (1890 units)","Krispak, Inc. is voluntarily recalling one lot of Spicy Sweet Mix due to a potential mislabeling, resulting in undeclared allergens. Good Sense City Mix (contains: Peanut, Milk, Almond, Cashew, Soy) was labeled as Good Sense Spicy Sweet Mix (contains: Peanut, Milk, Wheat, Soy), resulting in the undeclared allergens of Almond and Cashew.",10/8/2013,"10/08/2013",11/27/2013,"11/27/2013"
"Food",66471,"Terminated","Price Chopper Supermarkets","Schenectady","NY","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","NY, CT, VT","F-0098-2014","Class II","10 inch Apple Pie (baked and unbaked), NET WT 42 oz.(2 lb 10 oz), UPC 41735-22064 (unbaked) and 41735-23712 (baked), Price Chopper label.","All Sell By dates from Sept 25, 2013 through Oct 9, 2013",,"96 pies were shipped to the stores but only 6 affected pies were sold","The product contains undeclared eggs.",10/4/2013,"10/04/2013",11/6/2013,"11/06/2013"
"Devices",66472,"Ongoing","Philips Medical Systems (Cleveland) Inc","Cleveland","OH","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution - USA including AZ, CA, CO, DC, DE, FL, GA, HI, IA, IL, KY, MA, MD, MN, MO, MS, MT, NC, NJ, ND, NE, NV, NY, OH, OK, OR, PA, SD, TX, VT, WA, and WI. Internationally to Canada, Algeria, Argentina, Australia, Austria, Belgium, Brazil, China, Czech Republic, Denmark, Finland, France, Gabon, Germany, India, Indonesia, Ireland, Italy, Japan, Korea Republic, Lebanon, Malaysia, Mexico, Netherlands, New Zealand, Norway, Panama, Poland, Portugal, Russia, Saudi Arabia, Slovakia, Spain, Sweden, Switzerland, Taiwan, Turkey, United Arab Emirates, and United Kingdom.","Z-0089-2014","Class II","BrightView XCT is a gamma camera for Single Photon Emission Computed Tomography (SPECT), one unit per box. BrightView XCT is a gamma camera for Single Photon Emission Computed Tomography (SPECT) and integrates with an attenuation device consisting of flat panel x-ray imaging components. BrightView XCT produces non-attenuation corrected SPECT images and attenuation corrected SPECT images with x-ray transmission data that may also be used for scatter correction. The nuclear medicine images and the XCT images may be registered and displayed in a fused format (overlaid in the same orientation) to provide anatomical localization of the nuclear medicine data. ","The following model and serial numbers are affected by this recall: Model Number: 882454 Serial Number(s): 11000021, 11000082, and 11000111. Model Number: 882482 Serial Number(s): 6000002, 6000003, 6000004A, 6000005, 6000010, 6000011, 6000012, 6000013, 6000015, 6000016, 6000017, 6000018, 6000019, 6000020, 6000022, 6000023, 6000024, 6000025, 6000026, 6000027, 6000028, 6000029, 6000030, 6000031, 6000033, 6000036, 6000037, 6000038,6000040,6000041, 60000042, 6000043, 6000044, 6000045, 6000047, 6000048, 6000049, 6000050, 6000051, 6000052, 6000053, 6000054, 6000055, 6000056, 6000058, 6000059, 6000060, 6000061, 6000062, 6000063, 6000064, 6000065, 6000066, 6000067, 6000069, 6000070, 6000071, 6000072, 6000073, 6000074, 6000076, 6000077, 6000078, 6000079, 6000080, 6000081, 6000082, 6000083, 6000084, 6000085, 6000086, 6000087, 6000088, 6000089, 6000090, 6000091, 6000092, 6000093, 6000094, 6000095, 6000096, 6000097, 6000098, 6000099, 6000100, 6000101, 6000102, 6000103, 6000104, 6000105, 6000106, 6000107, 6000108, 6000109, 6000110, 6000111, 6000112, 6000113, 6000114, 6000115, 6000116, 6000117, 6000118, 6000119, 6000120, 6000121, 6000122, 6000123, 6000125, 6000126, 6000127, 6000128, 6000129, 6000130, 6000131, 6000132, 6000133, 6000134, 6000136, 6000138, 6000139, 6000140, 6000141, 6000142, 6000143, 6000144, 6000145, 6000146, 6000147, 6000148, 6000149, 6000150, 6000151, 6000152, 6000153, 6000154, 6000155, 6000156, 6000157, 6000158, 6000159, 6000160, 6000161, 6000162, 6000163, 6000164, 6000165, 6000166, 6000167, 6000168, 6000169, 6000170, 6000171, 6000172, 6000173, 6000174, 6000175, 6000176, 6000177, 6000178, 6000179, 6000180, 6000181, 6000182, 6000183, 6000184, 6000185, 6000186, 6000187, 6000188, 6000189, 6000190, 6000191, 6000192, 6000193, 6000194, 6000195, 6000196, 6000197, 6000198, 6000199, 6000200, 6000201, 6000202, 6000203, 6000204, 6000205, 6000206, 6000208, 6000209, 6000210, 6000211, 6000212, 6000213, 6000214, 6000215, 6000216, 6000217, 6000218, 6000219, 6000220, 6000221, 6000222, 6000223, 6000224, 6000225, 60002",,"371 units","Philips received reports from the field that the Flat Panel Detector (FPD) does not always remain securely latched in the stowed position.",9/3/2013,"09/03/2013",11/6/2013,"11/06/2013"
"Devices",66473,"Ongoing","Medtronic Neuromodulation","Minneapolis","MN","US","Voluntary: Firm Initiated","Letter","Worldwide distribution: US (Nationwide) including Puerto Rico and countries of: Algeria, Aruba, Austria, Belarus, Belgium, Brazil, Bulgaria, Chile, Colombia, Costa Rica, Croatia, Cyprus, Czech Republic, Denmark, Dominican Republic, Ecuador, Egypt, El Salvador, Estonia, Faroe Islands, Finland, France, French Polynesia, Georgia, Germany, Greece, Guadeloupe, Hungary, Iceland, India, Iran, Iraq, Ireland, Israel, Italy, Japan, Jordan, Kazakhstan, Kuwait, Latvia, Lebanon, Libya, Lithuania, Luxembourg, Malta, Martinique, Mexico, Morocco, Netherlands, Netherlands Antilles, New Caledonia, Norway, Oman, Pakistan, Panama, Peru, Poland, Portugal, Qatar, Reunion, Romania, Russian Federation, San Marino, Saudi Arabia, Serbia, Slovakia, Slovenia, South Africa, Spain, Sweden, Switzerland, Tunisia, Turkey, Ukraine, United Arab Emirates, United Kingdom, Uruguay, and Venezuela.","Z-0124-2014","Class II","Medtronic RestoreUltra, model 37712, and RestoreSensor, model 37714, Multi-program Rechargeable Neurostimulator for Spinal Cord Stimulation. Medtronic implantable neurostimulation system is indicated for spinal cord stimulation (SCS) systems as an aid in the management of chronic, intractable pain of the trunk and/or limbs-including unilateral or bilateral pain associated with the following conditions: - Failed Back Syndrome (FBS) or low back syndrome or failed back - Radicular pain syndrome or radiculopathies resulting in pain secondary to FBS or herniated disk - Postlaminectomy pain - Multiple back operations - Unsuccessful disk surgery - Degenerative Disk Disease (DDD)/herniated disk pain refractory to conservative and surgical interventions - Peripheral causalgia - Epidural fibrosis - Arachnoiditis or lumbar adhesive arachnoiditis - Complex Regional Pain Syndrome (CRPS), Reflex Sympathetic Dystrophy (RSD), or causalgia","all serial numbers ",,"64,163","Medtronic notified customers regarding over stimulation or stimulation in the wrong area related to select Medtronic neurostimulators. Upon a specific set of conditions, typically related to device recovery from an over discharge, there is a potential for over stimulation or stimulation directed to a lead electrode other than what was intended.",9/30/2013,"09/30/2013",11/6/2013,"11/06/2013"
"Devices",66473,"Ongoing","Medtronic Neuromodulation","Minneapolis","MN","US","Voluntary: Firm Initiated","Letter","Worldwide distribution: US (Nationwide) including Puerto Rico and countries of: Algeria, Aruba, Austria, Belarus, Belgium, Brazil, Bulgaria, Chile, Colombia, Costa Rica, Croatia, Cyprus, Czech Republic, Denmark, Dominican Republic, Ecuador, Egypt, El Salvador, Estonia, Faroe Islands, Finland, France, French Polynesia, Georgia, Germany, Greece, Guadeloupe, Hungary, Iceland, India, Iran, Iraq, Ireland, Israel, Italy, Japan, Jordan, Kazakhstan, Kuwait, Latvia, Lebanon, Libya, Lithuania, Luxembourg, Malta, Martinique, Mexico, Morocco, Netherlands, Netherlands Antilles, New Caledonia, Norway, Oman, Pakistan, Panama, Peru, Poland, Portugal, Qatar, Reunion, Romania, Russian Federation, San Marino, Saudi Arabia, Serbia, Slovakia, Slovenia, South Africa, Spain, Sweden, Switzerland, Tunisia, Turkey, Ukraine, United Arab Emirates, United Kingdom, Uruguay, and Venezuela.","Z-0125-2014","Class II","Medtronic Activa PC, model 37601, and Activa RC, model 37612, Multi-program Rechargeable Neurostimulator for Deep Brain Stimulation. Medtronic Activa RC and Activa PC Deep Brain Stimulators are indicated for Therapy for Parkinson's Disease - Bilateral stimulation of the internal globus pallidus (GPi) or the subthalamic nucleus (STN). Indicated for adjunctive therapy in reducing some of the symptoms of advanced, levodopa-responsive Parkinson's disease that are not adequately controlled with medication. Activa PC Deep Brain Stimulator is indicated for Therapy for Dystonia. Unilateral or bilateral stimulation of the internal globus pallidus (GPi) or the subthalamic nucleus (STN). Indicated as an aid in the management of chronic, intractable (drug refractory) primary dystonia, including generalized and segmental dystonia, hemidystonia, and cervical dystonia (torticollis), for individuals 7 years of age and older. Activa PC Deep Brain Stimulator is indicated for Obsessive-Compulsive Disorder. Bilateral stimulation of the anterior limb of the internal capsule, AIC, as an adjunct to medications and as an alternative to anterior capsulotomy for treatment of chronic, severe, treatment-resistant obsessive-compulsive disorder (OCD) in adult patients who have failed at least three selective serotonin reuptake inhibitors (SSRIs)","all serial numbers",,"38,294","Medtronic notified customers regarding over stimulation or stimulation in the wrong area related to select Medtronic neurostimulators. Upon a specific set of conditions, typically related to device recovery from an over discharge, there is a potential for over stimulation or stimulation directed to a lead electrode other than what was intended.",9/30/2013,"09/30/2013",11/6/2013,"11/06/2013"
"Devices",66475,"Ongoing","Mesa Laboratories, Inc.","Lakewood","CO","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution-USA (nationwide) and the country of Canada.","Z-0175-2014","Class II","pH 7.0 Buffer Solution Pint and Quart Bottles, Part Number 02.0030 for Pints and 02.0031 for Quarts. Packaged in Plastic Bottles. Can be sold individually or in cartons with 6 bottles per box (for quart bottles only). Used in the hemodialysis setting to calibrate pH meters.","ML-P7-1110 Exp NOV 11 2013, ML-P7-1118 Exp JAN 12 2014, ML-P7-1122 Exp FEB 23 2014, ML-P7-1128 Exp APR 17 2014, ML-P7-1137 Exp JUN 17 2014, ML-P7-1138 Exp JUL 4 2014, ML-P7-1148 Exp SEP 14 2014, ML-P7-1149 Exp SEP 19 2014, ML-P7-1158 Exp DEC 7 2014, ML-P7-1164 Exp JAN 19 2015",".","58,466 bottles","Mesa Laboratories, Inc. is recalling certain lots of pH 7.0 Buffer Solution due to mold growth.",9/13/2013,"09/13/2013",11/13/2013,"11/13/2013"
"Food",66476,"Ongoing","Kellogg Canada Corporate Office","Mississauga","ON","CA","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Canada","F-0087-2014","Class II","Pringles(R) SALT & VINEGAR Potato Chips, 168 g (UPC 064100852464) and 181 g (UPC 037000230090), Pringles Manufacturing Company, 1306 Highway 70 Bypass, Jackson, TN, USA 38301-5072 ","All lot codes and best before dates currently on shelf of the following product, where milk is not declared on the list of ingredients",,"182, 000 cases of 14 units","There was a change in Canadian labeling regulations where lactose was no longer sufficient, the label needed to stated ''contains milk''",10/7/2013,"10/07/2013",11/6/2013,"11/06/2013"
"Biologics",66477,"Terminated","Michigan Blood","Grand Rapids","MI","US","Voluntary: Firm Initiated","FAX","MI","B-0109-14","Class II","Red Blood Cells Leukocytes Reduced","W120613077024",".","1 unit","Blood products, collected from a donor who was previously deferred, were distributed.",8/15/2013,"08/15/2013",12/4/2013,"12/04/2013"
"Biologics",66477,"Terminated","Michigan Blood","Grand Rapids","MI","US","Voluntary: Firm Initiated","FAX","MI","B-0110-14","Class II","Cryoprecipitated AHF, Pooled","W120613170169",".","1 unit","Blood products, collected from a donor who was previously deferred, were distributed.",8/15/2013,"08/15/2013",12/4/2013,"12/04/2013"
"Biologics",66477,"Terminated","Michigan Blood","Grand Rapids","MI","US","Voluntary: Firm Initiated","FAX","MI","B-0108-14","Class II","Plasma Cryoprecipitated Reduced","W120613077024",".","1 unit","Blood products, collected from a donor who was previously deferred, were distributed.",8/15/2013,"08/15/2013",12/4/2013,"12/04/2013"
"Biologics",66478,"Terminated","South Texas Blood & Tissue Center","San Antonio","TX","US","Voluntary: Firm Initiated","FAX","TX","B-0112-14","Class II","Platelets","W140913337952",".","1 unit","Blood product, collected from a donor who traveled to an area considered endemic for malaria, was distributed.",7/29/2013,"07/29/2013",12/4/2013,"12/04/2013"
"Biologics",66479,"Terminated","Innovative Blood Resources","Saint Paul","MN","US","Voluntary: Firm Initiated","Letter","MN","B-0107-14","Class II","Platelets Pheresis Leukocytes Reduced Irradiated","W051513079114",".","1 unit","Platelet, with insufficient plasma volume to support the platelet yield, was distributed.",7/31/2013,"07/31/2013",12/4/2013,"12/04/2013"
"Biologics",66480,"Terminated","Kaiser Foundation Hospital","Woodland Hills","CA","US","Voluntary: Firm Initiated","Telephone","CA","B-0111-14","Class II","Red Blood Cells Leukocytes Reduced","W072013002391",".","1 unit","Blood products, collected from a donor who received a MMR vaccine, were distributed.",8/14/2013,"08/14/2013",12/4/2013,"12/04/2013"
"Biologics",66481,"Terminated","Mid-South Regional Blood Center","Memphis","TN","US","Voluntary: Firm Initiated","FAX","Tennessee; Pennsylvania","B-0093-14","Class II","Blood and Blood Products for Reprocessing","W227713350465; ",".","1","Blood products, collected from a donor who was at risk for variant Creutzfeldt-Jakob disease (vCJD), were distributed.",9/12/2013,"09/12/2013",12/4/2013,"12/04/2013"
"Biologics",66481,"Terminated","Mid-South Regional Blood Center","Memphis","TN","US","Voluntary: Firm Initiated","FAX","Tennessee; Pennsylvania","B-0092-14","Class II","Red Blood Cells Leukocytes Reduced","W227713350465; ",".","1","Blood products, collected from a donor who was at risk for variant Creutzfeldt-Jakob disease (vCJD), were distributed.",9/12/2013,"09/12/2013",12/4/2013,"12/04/2013"
"Biologics",66482,"Terminated","Hoxworth Blood Center","Cincinnati","OH","US","Voluntary: Firm Initiated","Letter","Ohio","B-0094-14","Class II","Red Blood Cells Leukocytes Reduced","W037712062073; W037712077244; ",".","2","Blood products, which were collected from a donor who traveled to a malarial endemic area, were distributed.",5/16/2013,"05/16/2013",12/4/2013,"12/04/2013"
"Devices",66483,"Ongoing","Cordis Corporation","Miami Lakes","FL","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution - US (nationwide) including Hawaii and Puerto Rico and states of: AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, IA, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV, and WY; and countries of: Canada and Panama.","Z-0081-2014","Class II","Cordis OPTEASE Vena Cava Filter Is indicated for use in the prevention of recurrent pulmonary embolism (PE) via percutaneous placement in the vena cava in the following situations: - Pulmonary thromboembolism when anticoagulants are contraindicated, - Failure of anticoagulant therapy for thromboembolitic disease, - Emergency treatment following massive pulmonary embolism where anticipate benefits of conventional therapy are reduce, and - Chronic, recurrent pulmonary embolism where anticoagulant therapy has failed, or is contraindicated.","15277209 15414364 15560257 15752429 15287302 15550200 15282988 15421769 15565526 15753478 15291145 15566741 15287301 15424883 15568635 15755303 15307389 15570058 15290545 15430268 15572971 15761315 15311637 15582190 15291146 15435116 15579473 15767566 15325508 15593534 15296278 15437943 15581926 15777997 15343213 15612686 15300299 15444314 15585734 15781096 15355694 15627268 15300995 15448466 15591471 15789723 15369568 15638012 15307390 15450171 15593533 15793939 15381573 15652041 15307999 15454044 15598216 15799364 15402503 15670744 15312441 15456163 15605008 15802178 15406808 15686286 15317387 15460104 15606053 15809353 15430934 15699350 15320551 15466748 15610330 15812239 15435039 15737306 15325507 15471008 15614689 15816462 15444313 15762046 15330287 15473247 15627966 15822489 15462543 15768649 15335203 15478342 15632159 15830469 15466749 15793940 15340786 15480569 15632931 15836564 15473249 15798681 15344590 15487383 15637332 15839559 15481997 15814435 15350806 15490348 15643482 15843764 15495653 15820539 15353473 15495652 15647053 15848940 15506862 15845139 15358769 15501261 15652040 15855704 15525423 15854729 15366482 15501864 15656567 15857848 15543607 15860770 15370260 15505204 15659250 15863068 15375958 15513357 15667702 15870135 15380088 15518418 15670742 15875172 15385970 15522427 15675940 15878645 15386960 15526913 15683409 15884283 15386963 15529312 15690240 15896484 15389049 15530028 15694650 15918862 15391340 15535323 15698900 15925083 15396804 15538438 15704985 15932575 15400773 15544128 15707198 15932586 15406817 15546019 15736818 15950327 15408669 15551821 15742478 15961621 15409489 15556617 15747949 ",,"29,395 units","Cordis identified a printing error on one unit of the Optease Vena Cava Filter, in which the orientation arrow for the femoral approach was printed in the incorrect direction. The error resulted in the filter being implanted upside down, requiring and additional percutaneous procedure to retrieve the filter. ",9/27/2013,"09/27/2013",11/6/2013,"11/06/2013"
"Food",66484,"Ongoing","Barrel O' Fun Snack Foods Co.","Perham","MN","US","Voluntary: Firm Initiated","Telephone","Retail Stores located in Colorado, Nebraska, New Mexico, South Dakota, and Wyoming.","F-0083-2014","Class I","the Snack Artist BBQ Flavored Potato Chips, Net Wt. 10 oz. (283 g), UPC 21130-29106. Distributed by Safeway, Inc. Pleasanton, CA 94566","Best By 08JAN2014 3255M27",,"3 cases (12-10 oz. bags per case)","Undeclared Milk. BBQ flavored potato chip bags inadvertently contain Sour Cream & Onion flavored potato chips, which contain milk.",10/10/2013,"10/10/2013",11/6/2013,"11/06/2013"
"Devices",66485,"Ongoing","Synthes USA HQ, Inc.","West Chester","PA","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution: USA (Nationwide) and countries of: Canada and Mexico.","Z-0202-2014","Class II","Synthes 8.5 MM Medullary Reamer Product Usage: An orthopedic manual surgical instrument is a nonpowered hand-held device intended for medical purposes to manipulate tissue, or for use with other devices in orthopedic surgery. This generic type of device includes the cerclage applier, awl, bender, drill brace, broach, bmT, corkscrew, countersink, pin crimper, wire cutter, prosthesis driver, extractor, file, fork, needle holder, impactor, bending or contouring instrument, compression instrument, passer, socket positioner, probe, femoral neck punch, socket pusher, reamer, rongeur, scissors, screwdriver, bone skid, staple driver, bone screw starter, surgical stripper, tamp, bone tap, trephine, wire twister, and wrench. ","Part No. 352.085 with lot numbers 20141 through 24510, and 4399543 through 5870257 ",".","2979","Complaints were received for intraoperative reamer head breakages which can allow for unretrieved fragments of non-implant grade material. ",10/3/2013,"10/03/2013",11/20/2013,"11/20/2013"
"Biologics",66487,"Terminated","OneBlood, Inc.","Hialeah","FL","US","Voluntary: Firm Initiated","Letter","Florida","B-0140-14","Class II","Platelets","2046554; ",,"1","Blood products, collected from a donor whose suitability to donate was not adequately determined, were distributed.",8/27/2013,"08/27/2013",12/18/2013,"12/18/2013"
"Biologics",66487,"Terminated","OneBlood, Inc.","Hialeah","FL","US","Voluntary: Firm Initiated","Letter","Florida","B-0137-14","Class II","Fresh Frozen Plasma","2411016; 2321193; ",,"2","Blood products, collected from a donor whose suitability to donate was not adequately determined, were distributed.",8/27/2013,"08/27/2013",12/18/2013,"12/18/2013"
"Biologics",66487,"Terminated","OneBlood, Inc.","Hialeah","FL","US","Voluntary: Firm Initiated","Letter","Florida","B-0141-14","Class III","Blood and Blood Products for Reprocessing","2046554; ",,"1","Blood products, collected from a donor whose suitability to donate was not adequately determined, were distributed.",8/27/2013,"08/27/2013",12/18/2013,"12/18/2013"
"Biologics",66487,"Terminated","OneBlood, Inc.","Hialeah","FL","US","Voluntary: Firm Initiated","Letter","Florida","B-0139-14","Class II","Cryoprecipitated AHF","2046554; ",,"1","Blood products, collected from a donor whose suitability to donate was not adequately determined, were distributed.",8/27/2013,"08/27/2013",12/18/2013,"12/18/2013"
"Biologics",66487,"Terminated","OneBlood, Inc.","Hialeah","FL","US","Voluntary: Firm Initiated","Letter","Florida","B-0138-14","Class II","Red Blood Cells","2411016; 2321193; 2046554; ",,"3","Blood products, collected from a donor whose suitability to donate was not adequately determined, were distributed.",8/27/2013,"08/27/2013",12/18/2013,"12/18/2013"
"Biologics",66488,"Terminated","Dept Of The Navy, Naval Medical Center","Portsmouth","VA","US","Voluntary: Firm Initiated","Letter","New Jersey","B-0095-14","Class II","Red Blood Cells Leukocytes Reduced","W021513001895; ",".","1","Blood product which was collected from a donor who was a resident of a malarial endemic area, was distributed. ",6/7/2013,"06/07/2013",12/4/2013,"12/04/2013"
"Biologics",66489,"Terminated","American National Red Cross (The) - North Central Region","Saint Paul","MN","US","Voluntary: Firm Initiated","Other","California","B-0142-14","Class III","Blood and Blood Products for Reprocessing","017LN04903; ",,"1","Blood product, collected from a donor whose suitability to donate was not adequately determined, was distributed.",8/28/2013,"08/28/2013",12/18/2013,"12/18/2013"
"Biologics",66490,"Terminated","Hoxworth Blood Center","Cincinnati","OH","US","Voluntary: Firm Initiated","Letter","Ohio","B-0096-14","Class II","Red Blood Cells Leukocytes Reduced","W037712069574; W037712029845; ",".","2","Blood products, which were collected from a donor who was a resident of a malarial endemic area, were distributed. ",4/25/2013,"04/25/2013",12/4/2013,"12/04/2013"
"Biologics",66491,"Terminated","Hoxworth Blood Center","Cincinnati","OH","US","Voluntary: Firm Initiated","Letter","Ohio","B-0144-14","Class III","Cryoprecipitated AHF, Pooled","W037712069983; ",,"1","Blood products, collected from a donor whose arm inspection was not documented, were distributed.",5/29/2013,"05/29/2013",12/18/2013,"12/18/2013"
"Biologics",66491,"Terminated","Hoxworth Blood Center","Cincinnati","OH","US","Voluntary: Firm Initiated","Letter","Ohio","B-0143-14","Class III","Red Blood Cells Leukocytes Reduced","W037712069983; ",,"1","Blood products, collected from a donor whose arm inspection was not documented, were distributed.",5/29/2013,"05/29/2013",12/18/2013,"12/18/2013"
"Biologics",66492,"Terminated","Hoxworth Blood Center","Cincinnati","OH","US","Voluntary: Firm Initiated","Letter","Ohio","B-0145-14","Class II","Red Blood Cells Leukocytes Reduced","W03771208775; ",,"1","Blood product, collected from a donor who reported travel to a malarial endemic area, was distributed.",6/7/2013,"06/07/2013",12/18/2013,"12/18/2013"
"Food",66495,"Ongoing","Turkey Hill Dairy, Inc.","Conestoga","PA","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","MA, MD, PA","F-1103-2014","Class II","Turkey Hill Pumpkin Pie Premium Ice Cream 48 oz. packaged in a paper tub and lid, distributed by Turkey Hill Dairy, Conestoga, PA. ","Sell By Date: 10/02/2014",".","756 tubs","Turkey Hill Dairy is initiating a voluntary recall on Turkey Hill Ice Cream because the product may be potentially contaminated with metal debris. ",10/4/2013,"10/04/2013",12/26/2013,"12/26/2013"
"Food",66495,"Ongoing","Turkey Hill Dairy, Inc.","Conestoga","PA","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","MA, MD, PA","F-1101-2014","Class II","Turkey Hill Premium Chocolate Peanut Butter Cup Ice Cream Size 1 Pint (473 ml) packaged in a paper cup and lid, distributed by Turkey Hill Dairy, Conestoga, PA. ","Turkey Hill Premium Chocolate Peanut Butter Cup Ice Cream Sell By Date:10/04/2014 ",".","232","Turkey Hill Dairy is initiating a voluntary recall on the Turkey Hill Premium Chocolate Peanut Butter Cup Ice Cream, Sell By Date:10/04/2014, because the product may be potentially contaminated with metal debris. ",10/4/2013,"10/04/2013",12/26/2013,"12/26/2013"
"Food",66495,"Ongoing","Turkey Hill Dairy, Inc.","Conestoga","PA","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","MA, MD, PA","F-1102-2014","Class II","Turkey Hill Stuff'd Moose Tracks Frozen Dairy Dessert Size: 1 Pint (473 ml), packaged in a paper cup and lid, distributed by Turkey Hill Dairy, Conestoga, PA. ","Turkey Hill Stuff'd Moose Tracks Frozen Dairy Dessert Sell By Date: 9/27/2014 ",".","4440 pints","Turkey Hill Dairy is initiating a voluntary recall on Turkey Hill Stuff'd Moose Tracks Frozen Dairy Dessert, Sell By Date: 9/27/2014, because the product may be potentially contaminated with metal debris. ",10/4/2013,"10/04/2013",12/26/2013,"12/26/2013"
"Devices",66496,"Ongoing","Ortho-Clinical Diagnostics","Rochester","NY","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution: US (nationwide) including states of: AK, CA, CT, CO, DC, FL, GA, IA, ID, IL, IN, KS, KY, LA, MA, ME, MI, MN, MO, MS, MT, NC, NE, NJ, NM, NY, OH, OK, OR, PA, SC, TN, TX, VA, VT, WA, WI, WV, WY, and Puerto Rico, and countries of: Australia, Brazil, Canada, Chile, China, Colombia, India, Japan, Mexico, Republic of Panama, Singapore, Venezuela, England, France, Germany, Italy & Spain.","Z-0525-2014","Class II","VITROS CA 125 II Calibrators For use in the calibration of the VITROS ECi/ECiQ Immunodiagnostic Systems, VITROS 3600 Immunodiagnostic System and VITROS 5600 Integrated System for the quantitative measurement of OC 125 defined antigen in human serum and plasma (EDTA or heparin).","product code: 680 0034; Lot numbers 1220, 1230, 1240, 1250",".","601 units","Ortho Clinical Diagnostics issued a Product Correction Notification for VITROS Immunodiagnostic Products CA 125 II Reagent Pack and Calibrators due to a positive shift in patient results.",10/9/2013,"10/09/2013",12/26/2013,"12/26/2013"
"Devices",66502,"Ongoing","Advanced Sterilization Products","Irvine","CA","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution - USA (nationwide) and the countries of Australia, Vietnam, Thailand, Malaysia, China, Korea (South), Mexico, Spain, Singapore, Hong Kong and Portugal.","Z-0434-2014","Class III","STERITITE Containers: STERITITE Container Kit, 1/4 size, 3'' high, product code: 13902; STERITITE Mini Mid Size, 3'' high, product code: 13903; STERITITE Container Kit, 1/2 size, 4'' high, product code: 13904; STERITITE Container Kit, 3/4 size, 4'' high, product code: 13905; STERITITE Container Kit, Full size, 4'' high, product code: 13906. The ASP STERITITE sealed container system provides an efficient and cost-effective way to package and protect surgical instruments for sterilization, transportation, storage, and aseptic presentation of contents.","Batch numbers: Batch 1030704 1030704 1030704 1030704 1030704 1030704 1030704 1030704 1030704 1030704 1030704 1030704 1030704 1030704 1030704 1030704 1030704 1030704 1030704 1030704 1030704 1030704 1071641 1071641 1030704 1030704 1071641 1030704 1071641 1071641 1071641 1071641 1030704 1030704 1071641 1071641 1071641 1079723 1079723 1079723 1079723 1079723 1079962 1079962 1079962 1079962 1079962 1079962 1079962 1079962 1079962 1079962 1079962 1079962 1081092 1081092 1081092 1081092 1081092 1081092 1081092 1081092 1081092 1081092 1081092 1071641 1081088 1081092 1081088 1081088 1081088 1081088 1081088 1081088 1081088 1081088 1081088 1081088 1081088 1082503 1081090 1081090 1081090 1081090 1082501 1082501 1082503 1082503 1082503 1082503 1082503 1082503 1082503 1082501 1082501 1082501 1082501 1082501 1082503 1082503 1082503 1081092 1082503 1081092 1081092 1081092 1081092 1081092 1081092 1081092 1085115 1081092 1081092 1081092 1086020 1086020 1086020 1086020 1086424 1086424 1081090 1086423 1087992 1086423 1082501 1081088 1085115 1085115 1086020 1081090 1087992 1086423 Batch 1030705 1030705 1030705 1030705 1030705 1030705 1030705 1071642 1071642 1071642 1071642 1071642 1071642 1071642 1071642 1071642 1030705 1030705 1030705 1030705 1030705 1030705 1078551 1078551 1078551 1078551 1078551 1078551 1078551 1078551 1078551 1079627 1079627 1079627 1079626 1079626 1079627 1079626 1079626 1079963 1079963 1079963 1080892 1079963 1080892 1080892 1080892 1080892 1080892 1080892 1080892 1080892 1080892 1080892 1079963 1080892 1079963 1079963 1079963 1079963 1079963 1079963 1079963 1079963 1080890 1079963 1080890 1080890 1080890 1080890 1081084 1081084 1081084 1080890 1080890 1081084 1081084 1080890 1080890 1080890 1081084 1081084 1081084 1081084 1081084 1081084 1081084 1082390 1081084 1082390 1082390 1081084 1082390 1084584 1084584 1084584 1085118 1085118 1085118 1082390 1082390 1082390 1082390 1085118 1082390 1082390 1082390 1081084 1082390 1081084 1085118 1086341 1081084 1081084 1085118 1086341 1081084 1081084 1081084 1081084 10",".","267 units total (252 units in US)","Advanced Sterilization Products (ASP) is recalling the SteriTite containers because they do not have consistent data to show that sterility assurance level of 10(-6) is achieved during the half-cycle test runs on new, unprocessed containers.",10/3/2013,"10/03/2013",12/11/2013,"12/11/2013"
"Devices",66504,"Ongoing","EKOS Corporation","Bothell","WA","US","Voluntary: Firm Initiated","E-Mail","Worldwide Distribution in Germany only.","Z-0133-2014","Class II","The EkoSonic Endovascular System employs high frequency (2-2.5 MHz), low power (0.585 watt average power per transducer) ultrasound to facilitate the delivery of physician-specified fluids in the peripheral vasculature and to deliver solutions into the pulmonary arteries. The EkoSonic Endovascular System is intended for the controlled and selective infusion of physician-specified fluids, including thrombolytics, into the peripheral vasculature and the infusion of solutions into the pulmonary arteries. The reusable EKOS EkoSonic Control Unit provides power to the system and the user interface for operator control. A reusable, non sterile Connector Interface Cable connects the EKOS EkoSonic Control Unit to the EkoSonic Endovascular Device.","PT3B-783. PT3B represents the model number. Adding 783 creates the serial number.",".","one unit","The EkoSonic Control Unit is recalled because it had the incorrect power entry module installed. It is missing an AC filter to reduce the noise and electrical interference.",10/2/2013,"10/02/2013",11/13/2013,"11/13/2013"
"Food",66505,"Ongoing","Specialty Enzymes & Biotechnologies","Chino","CA","US","Voluntary: Firm Initiated","Letter","Nationwide in US and worldwide to: Australia, Canada, Malaysia, Taiwan, Italy","F-0133-2014","Class II","Cellulase: ACTA 4-702 APEX 17-6262 APEX 6-9762 ARTH EB 10831 BETA GLUCANASE 1000 BROOK 8-352 CELLULASE 1000 CELLULASE 4000 CELLULASE CONC. CENTURY 7-152 CLENZSEB DIGESEB DIGESEB PB DIGESEB PLUS DIGESEB PLUS 401 DIGESEB SUPER DIGESEB SUPER 118 EB 10-14081 EB 10-15351 EB 12-706 EB 14-14201 EB 16-15612 EB 17-14161 EB 5-13302 EB 5-14121 EB 5-15361 EB 8-15731 EB 9-14181 EB 9-14191 EL 5-7212 GLOBAL 8-658 GREENZYME 427 HEMISEB JARL 3-164 NAT 9-185 NF 525 NHK 14-9451 NPC 270 NPC 5005 NPC 6006 NW 7B 9142 PB 10401 SEB GLUTEN RELIEF SEB GLUTEN RELIEF HNS SUPER 108 TUMMYEASE VEGPANZYME PLUS VR 5-8451 ","Lot Numbers: 3051077 3031052; 3061042 3041028 3041002 3031048 3041011 3041032 3031046 3021019 3021026; 3021053 3071063 3031064 3051045 3041039; 3031054 3031038 3031051 3021067; 3061049 3041012 3021073; 3031017 3071054 3041020 3081005 3021074; 3071059 3071007 3021048; 3041047 3021072; 3031016 3051028 3041021 3031033 3081009 3021015; 3021016 3041057 3051027; 3061019; 3071046; 3031063 3031058 3031022; 3041085 3071071; 3071072 3041055 3021032; 3021033; 3051089 3021022 3021035 3021066 3021041; 3031072; 3031073; 3021039 3021042 3041014; 3041058 3031047 3031018 3031025 3031021; 3041045 ",".","12637.50","Specialty Enzymes and Biotechnologies is recalling cellulase/mannanase and fungal protease because they may contain low levels of chloramphenicol.",10/3/2013,"10/03/2013",11/20/2013,"11/20/2013"
"Food",66505,"Ongoing","Specialty Enzymes & Biotechnologies","Chino","CA","US","Voluntary: Firm Initiated","Letter","Nationwide in US and worldwide to: Australia, Canada, Malaysia, Taiwan, Italy","F-0137-2014","Class II","XYLANASE 150,000 ","Lot Numbers: 3041043 ",".","420","Specialty Enzymes and Biotechnologies is recalling cellulase/mannanase and fungal protease because they may contain low levels of chloramphenicol.",10/3/2013,"10/03/2013",11/20/2013,"11/20/2013"
"Food",66505,"Ongoing","Specialty Enzymes & Biotechnologies","Chino","CA","US","Voluntary: Firm Initiated","Letter","Nationwide in US and worldwide to: Australia, Canada, Malaysia, Taiwan, Italy","F-0134-2014","Class II","Protease: APEX 10-7082 CENTURY 7-152 EB 2-14511 EB 5-16901 EB 8-14861 EB 9-14191 EXCLZYME EXCLZYME EN GLOBAL 8-658 HFN 7-7113 META 10-185 MHNHEM 2-158 PEPZYME AG PROTEASE - 1000 PROTEASE 250,000 SEB PRO FP 500 SEB PRO FP 600 SYS 7-7742 UT 11-216 N VEGPANZYME 1213 VEGPANZYME PLUS ","Lot Numbers: 3071023 3071011 3071039 3061013 3051087 3071034 3031065 3031065 3051054; 3071020; 3061004 3071038 3061033 3061014 3051022; 3061041; 3071070; 3051092; 3071001 3051084; 3071060 3051038 3041051; 3071040 3061025 3071029 3051052 3071027 3071005 ",".","5780","Specialty Enzymes and Biotechnologies is recalling cellulase/mannanase and fungal protease because they may contain low levels of chloramphenicol.",10/3/2013,"10/03/2013",11/20/2013,"11/20/2013"
"Food",66505,"Ongoing","Specialty Enzymes & Biotechnologies","Chino","CA","US","Voluntary: Firm Initiated","Letter","Nationwide in US and worldwide to: Australia, Canada, Malaysia, Taiwan, Italy","F-0135-2014","Class II","Cellulase & Protease: APEX 10-639 A DIGESEB DIGESEB PLUS DIGESEB SUPER EB 10-14171 EB 10-16192 EB 12-11331 EB 12-9205 EB 14-14201 EB 15-13662 EB 18-13081 EB 7-12831 EB 7-12901 EB 7-14211 EB 8-15731 EL 5-7212 ENZIGEST N FIZYME # 1209 N GLOBAL 8-658 HERB 10-6973 HFI 4-7601 HFN 7-7113 META 10-185 NB 6-7812 NF 525 NHK 14-9451 NPC 7007 NPC 8008 NUTRO 8-7961 OHS - 9804 PROTHERA 18-9724 PROTHERA 19-9723 PROTHERA 8-12182 SD 7-581 SEB GLUTEN RELIEF SEB GLUTEN RELIEF HNS UT 11-216 N VEGPANZYME 1213 VEGPANZYME 1X VEGPANZYME PLUS VT 11-693 ","Lot Numbers: 3071056 3051069 3061036 3041059; 3061050 3061040 3071014; 3071015 3061044 3051009 3051042 3061058 3041089 3031082 3041038 3041024 3061043 3051040 3061062 3031029; 3061047; 3061048; 3041030 3031050; 3031080; 3031081 3071002 3041013; 3051091 3041037; 3041054 3031028; 3041031 3041073 3041025; 3041026; 3041027; 3061060 3081004 3031034 3031055 3041007 3071045; 3061034 3031066 3051043; 3071006 3051007 3041056; 3061026 3031053 3041064 3051050; 3051056 3031049; 3041034 3061054 3071025; 3071026 3041084 3071012 ",".","13685","Specialty Enzymes and Biotechnologies is recalling cellulase/mannanase and fungal protease because they may contain low levels of chloramphenicol.",10/3/2013,"10/03/2013",11/20/2013,"11/20/2013"
"Food",66505,"Ongoing","Specialty Enzymes & Biotechnologies","Chino","CA","US","Voluntary: Firm Initiated","Letter","Nationwide in US and worldwide to: Australia, Canada, Malaysia, Taiwan, Italy","F-0136-2014","Class II","Papain: NF 4-608 B NF 4-6152 NUTRA 6-452 PAPAIN PROHYDROXY NF 4-714 ","Lot Numbers: 3061056 3071003 3071021 3070018 3061057 ",".","625","Specialty Enzymes and Biotechnologies is recalling cellulase/mannanase and fungal protease because they may contain low levels of chloramphenicol.",10/3/2013,"10/03/2013",11/20/2013,"11/20/2013"
"Devices",66506,"Ongoing","Medtronic Neuromodulation","Minneapolis","MN","US","Voluntary: Firm Initiated","Letter","Worldwide distribution: US (Nationwide) including Puerto Rico; and countries of: Algeria, Aruba, Austria, Belarus, Belgium, Brazil, Bulgaria, Canada, Chile, Colombia, Costa Rica, Croatia, Cyprus, Czech Republic, Denmark, Dominican Republic, Ecuador, Egypt, El Salvador, Estonia, Faroe Islands, Finland, France, French Polynesia, Georgia, Germany, Greece, Guadeloupe, Hungary, Iceland, India, Iran, Iraq, Ireland, Israel, Italy, Japan, Jordan, Kazakhstan, Kuwait, Latvia, Lebanon, Libya, Lithuania, Luxembourg, Malta, Martinique, Mexico, Morocco, Netherlands, Netherlands Antilles, New Caledonia, Norway, Oman, Pakistan, Panama, Peru, Poland, Portugal, Qatar, Reunion, Romania, Russian Federation, San Marino, Saudi Arabia, Serbia, Slovakia, Slovenia, South Africa, Spain, Sweden, Switzerland, Tunisia, Turkey, Ukraine, United Arab Emirates, United Kingdom, Uruguay, and Venezuela","Z-0279-2014","Class II","Medtronic Activa PC, model 37601, and Activa RC, model 37612, Activa SC, models 37602 and 37603. Multi-program Rechargeable Neurostimulator for Deep Brain Stimulation. ","all serial numbers",".","62,634","Medtronic notified customers regarding Loss of Stimulation of specific Implantable Neuro-Stimulators under the following specific conditions: Switching between groups with Multiple programs or creating program groups. Therapy can be restored with the Physician Recharge mode (RPM) of the Implantable Neurostimulator Recharger (INSR). ",9/30/2013,"09/30/2013",11/20/2013,"11/20/2013"
"Devices",66506,"Ongoing","Medtronic Neuromodulation","Minneapolis","MN","US","Voluntary: Firm Initiated","Letter","Worldwide distribution: US (Nationwide) including Puerto Rico; and countries of: Algeria, Aruba, Austria, Belarus, Belgium, Brazil, Bulgaria, Canada, Chile, Colombia, Costa Rica, Croatia, Cyprus, Czech Republic, Denmark, Dominican Republic, Ecuador, Egypt, El Salvador, Estonia, Faroe Islands, Finland, France, French Polynesia, Georgia, Germany, Greece, Guadeloupe, Hungary, Iceland, India, Iran, Iraq, Ireland, Israel, Italy, Japan, Jordan, Kazakhstan, Kuwait, Latvia, Lebanon, Libya, Lithuania, Luxembourg, Malta, Martinique, Mexico, Morocco, Netherlands, Netherlands Antilles, New Caledonia, Norway, Oman, Pakistan, Panama, Peru, Poland, Portugal, Qatar, Reunion, Romania, Russian Federation, San Marino, Saudi Arabia, Serbia, Slovakia, Slovenia, South Africa, Spain, Sweden, Switzerland, Tunisia, Turkey, Ukraine, United Arab Emirates, United Kingdom, Uruguay, and Venezuela","Z-0278-2014","Class II","Medtronic RestoreUltra, model 37712, and RestoreSensor, model 37714, Multi-program Rechargeable Neurostimulator for Spinal Cord Stimulation. ","all serial numbers",".","64,163","Medtronic notified customers regarding Loss of Stimulation of specific Implantable Neuro-Stimulators under the following specific conditions: Switching between groups with Multiple programs or creating program groups. Therapy can be restored with the Physician Recharge mode (RPM) of the Implantable Neurostimulator Recharger (INSR). ",9/30/2013,"09/30/2013",11/20/2013,"11/20/2013"
"Food",66508,"Ongoing","Creation's Garden Natural Products Inc","Valencia","CA","US","Voluntary: Firm Initiated","Letter","CA","F-0139-2014","Class II","WELLTRIENTS DIGESTAIDS FORMULA #2, 90 capsules per bottle. Item #61256-90","Lot#17061",".","935 bottles","Creation's Garden Natural Products (CGNP) is recalling Welltrients Digestaids Formula #2 because it has been found to contain chloramphenicol.",10/2/2013,"10/02/2013",11/20/2013,"11/20/2013"
"Devices",66509,"Completed","3M Company - Health Care Business","Saint Paul","MN","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution - USA including IN, TX, PA, FL, NV, SC, and TN and Internationally to Canada and Saudi Arabia.","Z-0428-2014","Class III","3M ESPE, Unitek Stainless Steel Permanent Molar Crowns Stainless Steel Crowns, are designed to fill the need for long term provisional coverage on adult molars and bicuspids as well as pediatric posterior and anterior teeth.","Product Code 902150 (Kit) Lot Codes N484233 and N463186 Product Code 900224 (Refill) Lot Codes N466509 and N473723",".","1419 (1325 US, 94 OUS)","3M is recalling specific lots of 3M ESPE Unitek Primary Stainless Steel Crowns - Series UR4 contain LL3 crowns which are incorrectly labeled as UR4 crowns.",6/5/2013,"06/05/2013",12/4/2013,"12/04/2013"
"Food",66510,"Ongoing","Ultra Laboratories","Carson","CA","US","Voluntary: Firm Initiated","Letter","Nationwide to US and United Kingdom","F-0140-2014","Class II","Digestive Health, 90 vegetable capsules","Lot numbers: 3021204 & 3061303",".","2200","Ultra Laboratories is recalling Digestive Health because a raw material used in its formulation may have been contaminated with chloramphenicol.",10/4/2013,"10/04/2013",11/20/2013,"11/20/2013"
"Food",66511,"Ongoing","Metagenics, Inc.","Aliso Viejo","CA","US","Voluntary: Firm Initiated","E-Mail","Nationwide in US and worldwide to Japan, Taiwan, Belgium, and Canada","F-0138-2014","Class II","Spectrazyme, 180 count, 60 count, 12 bottles/case, 20000 tablets/box, 14000 capsules/pail.","Lot Code: 0413083 0513007 0513008 ",".","1,171,300 units","Metagenics is recalling Spectrazyme because their raw material supplier informed them that enzymes in the blend may contain the antibiotic chloramphenicol.",10/11/2013,"10/11/2013",11/20/2013,"11/20/2013"
"Food",66512,"Ongoing","yoders country market","Bulls Gap","TN","US","Voluntary: Firm Initiated","E-Mail","Nationwide.","F-0115-2014","Class I","Custom made gift boxes containing: HONEY ROASTED PEANUTS, Net Wt. 11 oz. (311G), Dist.By: Dutch Valley Food Distributors, Inc. Myerstown, PA 10787, UPC 8 77245 00143 3","None",".","24 units","Honey Roasted Peanuts, packaged in custom gift boxes, contained milk and wheat which were not declared on the label.",10/11/2013,"10/11/2013",11/13/2013,"11/13/2013"
"Drugs",66519,"Ongoing","Taro Pharmaceuticals U.S.A., Inc.","Hawthorne","NY","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Nationwide","D-347-2014","Class III","Ciclopirox Shampoo 1%, Net Wt. 120 mL. bottles, Rx only. Mfd. by: Taro Pharmaceuticals Inc. Brampton, Ontario, Canada L6T 1C1. Dist. by: TARO Pharmaceuticals U.S.A., Inc. Hawthorne, NY 10532. NDC 51672-1351-8.","Lot #: H3135, Exp. January 2015",,"850 bottles","Subpotent. drug",10/16/2013,"10/16/2013",12/18/2013,"12/18/2013"
"Food",66520,"Ongoing","Western Nut Company, Inc.","Salt Lake City","UT","US","Voluntary: Firm Initiated","Telephone","Products distributed to Utah and California. No foreign, military/govt/VA consignees.","F-0099-2014","Class II","Western Nut Salt Lake City Roasted and Salted Inshell Peanuts, 6 oz (170g). Packaged in OPP (oriented polypropylene) bags. Receive bulk roasted/salted inshell peanuts from US Foods in 25 lb lined cases. Manufactured by Hampton Farms, Portales, NM for Western Nut.","Lot #20013P1",,"1,908 lbs","Western Nut is recalling certain lots of Roasted/Salted Inshell Peanuts due to unacceptable levels of Aflatoxin.",10/1/2013,"10/01/2013",11/6/2013,"11/06/2013"
"Devices",66521,"Ongoing","Beckman Coulter Inc.","Brea","CA","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution - USA (nationwide) and Internationally to Canada, Japan, India, Hong Kong, Guatemala, China, Brazil, Brunei Darussalam, Costa Rica, El Salvador, JordanMalaysia, Mexico, Panama, Philippines, South Africa, Taiwan, Thailand, Trinidad and Tobago, United Arab Emirates, Venezuela, and Viet Nam.","Z-0519-2014","Class II","Access Immunoassay Systems Reaction Vessels. The Access Immunoassay System is an in vitro diagnostic device used for the quantitative, semi-quantitative or qualitative determination of various analyte concentrations found in human body fluids. ","Part Number 81901, Lot Numbers: 13181168-13341170.",".","16,154 units","Beckman Coulter is initiating a recall for the Access Immunoassay Systems Reaction Vessels, including the Acess/Access 2 Immunoassay Systems, SYNCRON LXi 725 Clinical System, and UniCel DxC 600i SYNCHRON Access Clinical System because Beckman Coulter has observed an intermittent increase in Access System ''Wash Carousel Motion Errors'' with specific lots of Access System Reaction Vessels (RVs). If your system is experiencing these errors, the errors will be documented in the event log and the system will be in the Not Ready mode.",10/2/2013,"10/02/2013",12/26/2013,"12/26/2013"
"Devices",66524,"Ongoing","Intuitive Surgical, Inc.","Sunnyvale","CA","US","Voluntary: Firm Initiated","Letter","Worldwide distribution: US (nationwide) and countries of:Australia, Belgium, France, Italy and United Kingdom. .","Z-0110-2014","Class II","Single Site Bipolar Maryland Forceps Intuitive Surgical, Sunnyvale, CA. 94086 The Intuitive Surgical da Vinci Single-Site Instruments and Accessories used with the da Vinci Si Surgical System (IS3000) are indicated for use by trained physicians in an operating room environment for endoscopic manipulation of tissue, grasping, cutting, blunt and sharp dissection, approximation, clip-ligation, electrocautery and suturing during single incision laparoscopic cholecystectomy, benign hysterectomy and salpingo-oophorectomy with the da Vinci Single-Site Instruments and Accessories, including graspers, dissectors, needle drivers, scissors, suction irrigators, monopolar cautery, bipolar cautery, 5 mm curved cannulae, 5 mm and 10 mm straight cannulae, flexible blunt obturators, and the 5mm Single-Site Port. 2. ","Model number 428080-04 All distribution from 3-15-13 to 7-19-13. Batch/Lot # S10130510 S10130325 S10130314 S10130314 S10130415 S10130426 S10130329 S10130228 S10130418 S10130304 S10130418 S10130325 S10130325 S10130408 S10130408 S10130510 S10130415 S10130304 S10130314 S10130415 S10130418 S10130228 S10130329 S10130329 S10130415 S10130426 S10130426 S10130426 S10130408 S10130325 S10130228 S10130325 S10130426 S10130426 S10130418 S10130325 S10130510 S10130408 S10130415 S10130408 S10130228 S10130304 S10130418 S10130415 S10130426 S10130314 S10130426 S10130418 S10130228 S10130228 S10130304 S10130415 S10130415 S10130418 S10130408 S10130329 S10130314 S10130228 S10130228 S10130314 S10130325 S10130415 S10130426 Batch/Lot # S10130426 S10130418 S10130408 S10130325 S10130415 S10130415 S10130415 S10130418 S10130325 S10130325 S10130329 S10130325 S10130314 S10130329 S10130426 S10130314 S10130408 S10130329 S10130426 S10130426 S10130325 S10130415 S10130426 S10130426 S10130325 S10130325 S10130325 S10130329 S10130329 S10130408 S10130415 S10130408 S10130408 S10130415 S10130415 S10130418 S10130426 S10130415 S10130325 S10130408 S10130418 ",,"286 boxes ( 6 instruments per box) for a total of 2,220 affected clinical product","A limited number of FDA-cleared instruments for da Vinci Single Site use, Bipolar Maryland and curved needle Driver, were shipped without the correct revision of the user manual which provided added instruction for use of these additional Single Site instruments including indication, warnings and precautions.",10/2/2013,"10/02/2013",11/6/2013,"11/06/2013"
"Devices",66524,"Ongoing","Intuitive Surgical, Inc.","Sunnyvale","CA","US","Voluntary: Firm Initiated","Letter","Worldwide distribution: US (nationwide) and countries of:Australia, Belgium, France, Italy and United Kingdom. .","Z-0111-2014","Class II","Single Site Curved Needed Driver Intuitive Surgical, Sunnyvale, CA. 94086 The Intuitive Surgical da Vinci Single-Site Instruments and Accessories used with the da Vinci Si Surgical System (IS3000) are indicated for use by trained physicians in an operating room environment for endoscopic manipulation of tissue, grasping, cutting, blunt and sharp dissection, approximation, clip-ligation, electrocautery and suturing during single incision laparoscopic cholecystectomy, benign hysterectomy and salpingo-oophorectomy with the da Vinci Single-Site Instruments and Accessories, including graspers, dissectors, needle drivers, scissors, suction irrigators, monopolar cautery, bipolar cautery, 5 mm curved cannulae, 5 mm and 10 mm straight cannulae, flexible blunt obturators, and the 5mm Single-Site Port. ","Model number 428088-12 All distribution from 3-15-13 to 7-19-13. Batch/Lot # S10130521 S10130405 S10130401 S10130405 S10130405 S10130521 S10130405 S10130405 S10130406 S10130406 S10130411 S10130411 S10130613 S10130405 S10130327 S10130327 S10130319 S10130319 S10130626 S10130703 S10130405 S10130319 S10130521 S10130613 S10130502 S10130405 S10130401 S10130406 S10130521 S10130613 S10130502 S10130406 S10130411 S10130405 S10130327 S10130412 S10130613 S10130314 S10130411 S10130327 S10130327 S10130411 S10130406 S10130613 S10130626 S10130412 S10130521 S10130405 S10130405 S10130314 S10130401 S10130411 S10130626 S10130703 S10130703 S10130703 S10130626 S10130613 S10130502 S10130401 S10130412 S10130406 Batch/Lot # S10130412 S10130405 S10130412 S10130314 S10130319 S10130502 S10130613 S10130405 S10130314 S10130405 S10130405 S10130613 S10130709 S10130703 S10130314 S10130319 S10130319 S10130314 S10130412 S10130521 S10130626 S10130411 S10130405 S10130521 S10130405 S10130319 S10130319 S10130319 S10130405 S10130405 S10130405 S10130314 S10130314 S10130314 S10130314 S10130319 S10130319 S10130319 S10130319 S10130314 S10130314 S10130314 S10130405 S10130327 S10130327 S10130405 S10130405 S10130412 S10130405 S10130327 S10130406 S10130406 S10130406 S10130613 S10130502 S10130613 S10130502 S10130521 S10130502 S10130613 S10130411 S10130502 Batch/Lot # S10130412 S10130521 S10130521 S10130521 S10130521 S10130613 S10130521 S10130405 S10130401 S10130405 S10130405 S10130613 S10130613 S10130703 S10130703 S10130319 S10130319 S10130626 S10130703 S10130405 S10130405 S10130405 S10130405 S10130521 S10130521 S10130405 S10130327 S10130406 S10130412 S10130412 S10130411 S10130401 S10130405 S10130521 S10130502 S10130406 S10130613 S10130411 S10130613 S10130613 S10130405 S10130401 S10130327 S10130405 S10130406 S10130405 S10130405 S10130405 S10130319 S10130319 S10130406 S10130406 S1",,"504 devices for a total of 2,220 affected clinical product.","A limited number of FDA-cleared instruments for da Vinci Single Site use, Bipolar Maryland and curved needle Driver, were shipped without the correct revision of the user manual which provided added instruction for use of these additional Single Site instruments including indication, warnings and precautions.",10/2/2013,"10/02/2013",11/6/2013,"11/06/2013"
"Food",66525,"Ongoing","Nature's Value Inc. ","Coram","NY","US","Voluntary: Firm Initiated","Letter","FL & IN","F-0826-2014","Class II","Vitacost Super Daily Enzymes 500 mg caps, product is packaged in a plastic bottle with 240 capsules per bottle, UPC Code: 844197017164. Manufactured for Vitacost Lexington, NC 27295.","Lot No: 1) 132176, EXP. DATE 06/15, Item #: VCT 7017164 and 2) Lot No: 132843, EXP. DATE 07/15, Item #: VCT7017164 ",,"796,800 total capsules for all varieties","Nature's Value Inc. has recalled three Dietary Supplements due to the presence of Chloramphenicol, an antimicrobial agent.",10/17/2013,"10/17/2013",12/18/2013,"12/18/2013"
"Food",66525,"Ongoing","Nature's Value Inc. ","Coram","NY","US","Voluntary: Firm Initiated","Letter","FL & IN","F-0824-2014","Class II","Vitacost Mega Spectrum Enzyme, packaged with 180 Vegetarian Capsules, UPC Code: 84419701519. Manufactured for Vitacost Lexington, NC 27295","Lot No: 131623, EXP. DATE 05/15, Item #: VCT7015191",,"796,800 total capsules for all varieties","Nature's Value Inc. has recalled two Dietary Supplements due to the presence of Chloramphenicol, an antimicrobial agent.",10/17/2013,"10/17/2013",12/18/2013,"12/18/2013"
"Food",66525,"Ongoing","Nature's Value Inc. ","Coram","NY","US","Voluntary: Firm Initiated","Letter","FL & IN","F-0825-2014","Class II","Digestive Enzyme Complex/Enzyme Formula Caps, Quantity:13M, Product #: IB286, product is packaged in bulk form. Manufactured For: Indiana Botanic. Manufactured by Nature's Value Inc. 468 Mill Road, Coram, NY 11727, Telephone: 631-846-2500.","Lot No: 132337",,"796,800 total capsules for all varieties","Nature's Value Inc. has recalled two Dietary Supplements due to the presence of Chloramphenicol, an antimicrobial agent.",10/17/2013,"10/17/2013",12/18/2013,"12/18/2013"
"Devices",66526,"Terminated","Intuitive Surgical, Inc.","Sunnyvale","CA","US","Voluntary: Firm Initiated","Visit","Worldwide Distribution - USA including Puerto Rico and the countries of Australia, Austria, Argentina, Belgium, Bulgaria, Brazil, Canada, Chile, China, Czech Republic, Denmark, Egypt, Finland, France, Germany, Greece, India, Indonesia, Ireland, Israel, Japan, Kuwait, Mexico, Netherlands, Norway, Pakistan, Panama, Philippines, Poland, Portugal, Qatar, Romania, Russia, Saudi Arabia, Singapore, Slovakia, Slovenia, South Korea, Spain, Sweden, Switzerland, Taiwan, Thailand, Turkey, United Kingdom, Uruguay and Venezuela.","Z-0139-2014","Class II","Patient Cart used in conjunction with the da Vinci S surgical and SI System. Intuitive Surgical 1266 Kifer Road Sunnyvale, CA 94086 The Patient Side Cart (PSC) is a robotic platform used for da Vinci Surgery. It is the operative component for both da Vinci systems and its primary function is to support he instrument arms and camera arm. It uses remote center technology. The remote center is a fixed point in space around which the Patient Cart arms move. Remote center technology enables the system to maneuver instruments and endoscopes in the surgical site while exerting minimal force on the patient body wall. The Patient Cart works in the sterile field, assisting the Surgeon Console operator by exchanging instruments and endoscopes, and by performing other patient-side activities. To help ensure patient safety, the action of the Patient Cart operator take precedence over actions of the Surgeon Console operator.","Model IS2000 and IS 3000",".","1754 patient carts","Increased number of complaints regarding fluid entering the patient card base of the da Vinci S and SI systems.",11/30/2012,"11/30/2012",11/13/2013,"11/13/2013"
"Drugs",66528,"Ongoing","Actavis Elizabeth LLC","Elizabeth","NJ","US","Voluntary: Firm Initiated","Letter","Nationwide","D-018-2014","Class II","Alprazolam Orally Disintegrating Tablets, USP 2 mg, 100 count bottles, Rx Only, MFG. BY ACTAVIS ELIZABETH LLC., Elizabeth, NJ, NDC 0228-4025-11","Lot # 59380831, Exp. May 2014",".","756 bottles ","Failed Tablet/Capsule Specifications; partial tablet erosion resulting in tablet weights below specification in some tablets",10/9/2013,"10/09/2013",12/4/2013,"12/04/2013"
"Devices",66529,"Ongoing","Synthes USA HQ, Inc.","West Chester","PA","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution - USA (Nationwide) and Canada.","Z-0341-2014","Class II","Synthes Soft Tissue Retractor Small Extendible Offset blade facilitates easy preparation of the epipereosteal cavity for percutaneous plate insertion.","Part # Lot # 325.01 1776332 325.01 1834589 325.01 1855361 325.01 1893067 325.01 1903596 325.01 1952258 325.01 1986932 325.01 3067805 325.01 3150691 325.01 3179456 325.01 3186865 325.01 3220973 325.01 3241083 325.01 3268079 325.01 3360992 325.01 3719234 325.01 3818913 325.01 4948929 325.01 4994679 325.01 4994680 325.01 5031083 325.01 5031085 325.01 5391773 325.01 5420979 325.01 5420980 325.01 5476369 325.01 5476370 325.01 5510070 325.01 5544585 325.01 5546329 325.01 5563699 325.01 5569041 325.01 5624246 325.01 5657366 325.01 5677289 325.01 5759764 325.01 5759765 325.01 5779363 325.01 7698954 325.01 7826103 ",,"374","The potential exists for the locking screw nut to break on the Soft Tissue Retractor if it is overt-tightened.",9/24/2013,"09/24/2013",11/27/2013,"11/27/2013"
"Devices",66530,"Ongoing","Synthes USA HQ, Inc.","West Chester","PA","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution - USA (nationwide) and Internationally to Canada and Mexico.","Z-0429-2014","Class II","Synthes Soft Tissue Retractor Small Extendible. Offset blade facilitates easy preparation of the epipereosteal cavity for percutaneous plate insertion.","Part J5957AC (old), and Part J5957F (new)",".","374","The small extendible Soft Tissue Retractor was recalled due to locking nut (clamping sleeve) malfunction. ",8/1/2013,"08/01/2013",12/11/2013,"12/11/2013"
"Devices",66532,"Ongoing","Medtronic Vascular, Inc.","Santa Rosa","CA","US","Voluntary: Firm Initiated","Letter","Nationwide Distribution.","Z-0154-2014","Class II","Resolute Integrity Zotarolimus-eluting Coronary Stent: Stent ID 3.0 mm; Stent length 34 mm; Rx, Sterile. Mfg in Medtronic Ireland, Galaway, Ireland. Distributed by: Medtronic Inc. Minneapolis, MN. Indicated for improving coronary luminal diameters in patients.","Model: RSINT30034UX; Customer Facing Number: RSIST30034UX. Expiration date: 25 May 2014.",".","201 units","A small number of units in lot number 0006573585 of the Resolute Integrity Zotarolimus-Eluting Coronary Sten System may contain a compliance chart incorrectly referencing a 2.25 mm diameter instead of the correct 3.0mm.",10/7/2013,"10/07/2013",11/13/2013,"11/13/2013"
"Devices",66533,"Ongoing","Aesculap, Inc.","Center Valley","PA","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution - USA Nationwide and countries of: Austria, Germany, Japan, and Taiwan.","Z-0479-2014","Class II","Aesculap GNI161 Bipolar Foot Control Product Usage: The Aesculap Bipolar Coagulator is intended for use in surgery to generate electrical power for bipolar instruments. Bipolar coagulators are used in neurosurgery, ENT surgery, urology, laparoscopy, and plastic surgery. ","all GN161's distributed between 4/28/2009 and 5/22/2013. ",,"85","Complaints were received for the GN161 Bipolar Foot Control reporting that the bipolar energy did not stop after release of the foot control.",9/10/2013,"09/10/2013",12/18/2013,"12/18/2013"
"Devices",66534,"Ongoing","Aesculap, Inc.","Center Valley","PA","US","Voluntary: Firm Initiated","Letter","Worldwide distribution: USA (nationwide) GA, TN, CA, WY, NV, TX, OK, OH, and IL; and internationally to Canada.","Z-0361-2014","Class II","Aesculap Arcadius XP L Trial Insertion Instrument (ME020R/ME020R-US)","model no. ME020R",,"30","The trial insertion instrument may disassemble during use due to a potentially weak weld on then trial inserter shaft block area located near the thumb wheel. ",9/20/2013,"09/20/2013",11/27/2013,"11/27/2013"
"Devices",66536,"Ongoing","Aesculap, Inc.","Center Valley","PA","US","Voluntary: Firm Initiated","Telephone","Distributed in FL and MD.","Z-0492-2014","Class II","Aesculap Columbus Revision CoCr 15mm distal and posterior spacers, sizes F5-F7","lots: 51468773, 51447588, 51468302, 51503760, 51571394, 51585136, 51447597",".","24","The Columbus Revision CoCr 15 mm distal and posterior implant spacers, sizes F5-F7, were not compatible.",9/19/2013,"09/19/2013",12/26/2013,"12/26/2013"
"Devices",66537,"Ongoing","Draeger Medical, Inc.","Telford","PA","US","Voluntary: Firm Initiated","Letter","Worldwide distribution: US (Nationwide)and in the country of Canada. (note: the ceiling supply units are not classified as a medical device by Health Canada).","Z-0282-2014","Class II","Draeger Movita 603x/DVE 803x Ceiling Supply Unit. It is intended for use in operating theaters and intensive care","Catalog numbers:MZ00614, MZ01038, MZ02190, MZ02254, and MZ02332",".","139","Cases were encountered with the Draeger Movita 603x/DVE 803x Ceiling Supply Units where the drive screw in the motor unit broke and the lift arm fell down approximately 60 cm (23.6 inches). ",9/30/2013,"09/30/2013",11/20/2013,"11/20/2013"
"Devices",66538,"Ongoing","Synthes USA HQ, Inc.","West Chester","PA","US","Voluntary: Firm Initiated","E-Mail","Nationwide Distribution - only AZ .","Z-0455-2014","Class II","Synthes Zero-P VA Implant 7 MM Height Parallel Sterile The Synthes Zero-P VA Implant 7 MM Height Parallel Sterile is a stand alone anterior cervical interbody fusion device indicated for use in skeletally mature patients with degenerative disc disease (DDD) with accompanying radicular symptoms at one level from C2-T1. ","part no. 04.647.117S, Plate implant no. 7706771, spacer lot no. 7675745",".","1","A potential non conformance was identified with the Zero-P VA plate where the screw could back out if the blocking mechanism is not visually confirmed to properly cover the head of the screw. ",9/30/2013,"09/30/2013",12/11/2013,"12/11/2013"
"Food",66539,"Ongoing","Bio-Cat Inc","Troy","VA","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","The products were distributed to manufacturers and distributors nationwide and to Canada.","F-0178-2014","Class II","Xylanase Enzyme Blends, bulk, custom blended formulations identified as xylanase 1000, xylanase 150,000 XU, synerzyme-ae, brizyme, Cellulase Special Blend OMRI, xylanase amylase blend, Bio-Cat Ruminant Enzyme, Feed Blend ws alkacel 20x, BC-XR, enzyme blend #2237, CHX blend, EB-7 multi-enzyme blend EB110311-01, EB020812-01, xylanase 70,000, nut 14-500, ultra blend 102 xylanase 10,000, bb cd blend #3, soy blend, amiron blend, Formula #121412b, erc530b, pn digestive blend, digest basic, blend 0313, xylanase 20,000, EC-CHPX, Xylanase 50,000 XU, Xylanase 50m XU, Xylanase 25,000, Xylanase 190,000 XU, af-5x, silage blend, xylanase concentrate, Enzyme Blend 1, and Enzyme Blend 2, packed in boxes or drums ranging from 1 kg to 25 kg, item # XYXP, labeled in part ***Manufactured by BIO-CAT, INC.9117 Three Notch Road Troy, Virginia 22974 Telephone (800) 545-9052 Fax (434) 589-3301 E-mail: info@bio-cat.com Website: www.bio-cat.com*** ","Lots: xy150-vw08 synae-vw18 synae-vw19 synae-vw20 xy150-tw14 bri-xw16 xy150-tw22 xy150-yw05 csbomri-xw20 xab-vw21 xab-aw07 bcr-yw14 bcr-aw05 fbws-uw04 fbws-aw02 alc20-ww05 xy150-xw30 bcxr-tw04 bcxr-ww12-a (375)/bcxr-ww12-b (125) bcxr-yw27 bcxr-aw15 eb2237-vw14 chxb-uw27 xy150-zw17 xy150-tw15 xy150-uw21 xy150-xw02 xyc-yw06 xy150-uw26 ali13008-01 ali13008-02 ali13008-13 ali13036-01 ali13053-05 ali13071-01 ali13071-02 ali13140-02 ali13140-03 ali13200-08 ali13200-09 ali13212-04 ali13157-11 ali13206-05 ali13206-06 bbcdb-vw25 bbcdb-xw02 soyb-tw21 soyb-zw02 xy150-tw16 xy150-vw14 xy150-ww08 amib-uw06 amib-uw13 f121412b-vw13 erc530b-xw22 xy150-aw13 xy150-aw20 pndb-xw28 xy150-tw23 db-bw12 b0313-vw22 xy10-uw15 xy20-ww02 xy10-xw20 ecchpx-zw18 xy50-tw09 xy150-tw09 xy50-tw09 xy150-tw16 xy150-vw22 xy150-ww05 xy50-ww09 xy150-ww22 xy150-xw23 xy150-yw24 xy150-zw02 xy50-zw11 xy150-zw19 xy150-aw07 xy50-aw23 xy25-xw22 xy200-vw22 xy150-uw20 af5x-uw04 sb-xw09 xy150-uw08 xy01-vw11 xyc-ww24 xyc-ww18 eb1-yw03 eb2-yw03 ",,"3276 kg total for all products","Raw material enzymes intended for further manufacturing of foods and dietary spplements may be contaminated with chloramphenicol.",9/26/2013,"09/26/2013",11/27/2013,"11/27/2013"
"Food",66539,"Ongoing","Bio-Cat Inc","Troy","VA","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","The products were distributed to manufacturers and distributors nationwide and to Canada.","F-0176-2014","Class II","Cellulase Enzyme Blends, bulk, custom blended formulations identified as Cellulase BX and Celluase Conc, packed in boxes or drums ranging from 1 kg to 25 kg, item # CELIND, labeled in part ***Manufactured by BIO-CAT, INC.9117 Three Notch Road Troy, Virginia 22974 Telephone (800) 545-9052 Fax (434) 589-3301 E-mail: info@bio-cat.com Website: www.bio-cat.com*** ","Lots: fsb-tw07 fsb-uw14 fsb-vw08 pob-tw31 pob-vw27 pob-xw23 pob-aw05 cbx-yw12 cbx-xw06 cbx-xw10 cbx-aw09 ccu-yw06 ",,"3276 kg total for all products","Raw material enzymes intended for further manufacturing of foods and dietary spplements may be contaminated with chloramphenicol.",9/26/2013,"09/26/2013",11/27/2013,"11/27/2013"
"Food",66539,"Ongoing","Bio-Cat Inc","Troy","VA","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","The products were distributed to manufacturers and distributors nationwide and to Canada.","F-0177-2014","Class II","Pectinase Enzyme Blends, bulk, custom blended formulations identified as pectinase 500, pectinase 1000, Pectinase 350 Endo-pg/gm, PC Blend 14, Nut 14-500, pectinase 3500, gastro blend 0111, Digestive Blend 021894, enzyme complex 5763, pectinase 1750, pectinase 350, EC-CHPX, enzyme blend for cyto grn, pectinase 150m, and Cellulase 3, packed in boxes or drums ranging from 1 kg to 25 kg, item # PECCI, labeled in part ***Manufactured by BIO-CAT, INC.9117 Three Notch Road Troy, Virginia 22974 Telephone (800) 545-9052 Fax (434) 589-3301 E-mail: info@bio-cat.com Website: www.bio-cat.com*** ","Lots: SYNAE-VW18 SYNAE-VW19 SYNAE-VW20 BRI-XW16 E7X-TW03 E7X-UW20 E7XBY-UW21 E7X-WW26 E7XBY-XY07 E7X-YW25 E7X-ZW24 E7X-BW16 PE003-UW21 PE003-XW02 EBY2X-UW22 EBW-VW12 EBW-VW13 EBW-VW14 EBW-XW10 EBW-XW13 EBW-XW14 EBY2X-XW15 EBW-YW11 EBW-YW12 EBW-YW13 EBW-AW19 EBW-AW20 PE350-VW01 PE350-YW19 EBW-AW21 pe05-ww30 ALI13249-03 ali13024-02 ali13036-01 ali13212-04 ali13157-09 bgb0111-vw26 db18-xw24 db18-yw04 db18-yw06 db18-aw22 DB18-ZW23 DB18-AW30 ec5763-bw06 pe035-tw23 peo35-tw14 pe1750-vw11 pe350-vw11 ECHPX-ZW18 pe350-xw22 pe350-aw13 ebcyto-yw28 ebcyto-aw09 ebcyto-bw19 pe150-vw20 pe150-bw05 cell3-ww18 cell3-xw07 cell3-aw01 cell3-AW14 pe01-uw07 pe035-yw07 EB7-XW08 EB7-AW23 ",,"3276 kg total for all products","Raw material enzymes intended for further manufacturing of foods and dietary spplements may be contaminated with chloramphenicol.",9/26/2013,"09/26/2013",11/27/2013,"11/27/2013"
"Biologics",66540,"Terminated","Blood Systems Inc ","Scottsdale","AZ","US","Voluntary: Firm Initiated","Telephone","Arizona","B-0098-14","Class II","Red Blood Cells Leukocytes Reduced","W0410130438031",,"1 unit","Blood product, collected from a donor who traveled to an area considered endemic for malaria, was distributed.",8/29/2013,"08/29/2013",12/18/2013,"12/18/2013"
"Devices",66542,"Ongoing","Lin-Zhi International Inc","Sunnyvale","CA","US","Voluntary: Firm Initiated","Letter","US Distribution in CA.","Z-0386-2014","Class III","Single Analyte Urine DAU Control (5 m L Norbuprenorphine, Level II control For In Vitro Diagnostic Use Only. store at 2 - 8 degrees C. Contents: Contains 13 mg/Ml of Norbuprenorphine in human urine with sodium azide as a preservative. Manufacturer: Lin-Zhi International, Inc. 670 Almanor Ave. Sunnyvale, CA 94085 The Norbuprenorphine Drug of Abuse (DUB) Positive control is used as assayed quality control material to monitor the precision of the Lin-Zhi International, Inc. Buprenorphine Enzyme immunoassay on the Synchron clinical analyzer. It in intended for the qualitative and semi-quantitative determination of norbuprenorphine in human urine.","Catalog #A68825, Lot #1307086; Exp. 3/28/2014/",".","60 items","Product catalog # A68825 Norbuprenorphine 13 ng/mL Level 2 Controls gives a decreased concentration reading due to the degradation of the NBUP analyte in solution.",10/3/2013,"10/03/2013",12/4/2013,"12/04/2013"
"Devices",66545,"Ongoing","Smith & Nephew Inc","Memphis","TN","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","USA Nationwide Distribution in the states of: AZ, NC, IA, PA, OH, MD, and TN.","Z-0131-2014","Class II","GENESIS(R) II, NON-POROUS TIBIAL BASE, SIZE 6, RIGHT, QTY: (1), REF 71420188. Product Usage: orthopaedic","Batch No. 13GM09505",".","4 units","Swapped product. Non-porous tibial base size 5 L was mis-packaged as size 6 R and vice versa.",10/7/2013,"10/07/2013",11/13/2013,"11/13/2013"
"Devices",66545,"Ongoing","Smith & Nephew Inc","Memphis","TN","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","USA Nationwide Distribution in the states of: AZ, NC, IA, PA, OH, MD, and TN.","Z-0130-2014","Class II","GENESIS(R) II, NON-POROUS TIBIAL BASE, SIZE 5, LEFT, QTY: (1), REF 71420168. Product Usage: orthopaedic","Batch No. 13GM11272",".","4 units","Swapped product. Non-porous tibial base size 5 L was mis-packaged as size 6 R and vice versa.",10/7/2013,"10/07/2013",11/13/2013,"11/13/2013"
"Devices",66546,"Ongoing","Advanced Sterilization Products","Irvine","CA","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution-USA (nationwide) and the countries of EMEA, APAC, Japan, Canada. AE, AU, BE, BH, CA, CH, CL, CN, CO, DE, EC, ES, GB, GR, HK, HU, IL, IN, IT, JP, KR, KW, MX, MY, NX, PA, PH, PK, PL, PR, QA, RU, SA, SG, SI, TH, VE, VN, ZA, and Tripoli.","Z-0190-2014","Class II","Sterrad 100NX, Product Code: 10104. Used to sterilize heat and moisture sensitive reusable medical devices.","Batch 1041070019 1041080059 1041080056 1041080058 1041080055 1041080064 1041080063 1041080057 1041080060 1041070023 1041070022 1041080069 1041080070 1041080066 1041080068 1041080072 1041080073 1041080082 1041080077 1041080061 1041080074 1041080076 1041080078 1041080079 1041080081 1041080087 1041080071 1041080093 1041080080 1041080095 1041080090 1041080089 1041080088 1041080097 1041080098 1041080091 1041080099 1041080100 1041080101 1041080096 1041080159 1041080103 1041080102 1041080104 1041080160 1041080167 1041080172 1041080168 1041080169 1041080174 1041070049 1041070051 1041070048 1041080083 1041080086 1041080165 1041080173 1041080175 1041080164 1041080163 1041080180 1041080084 1041080182 1041080184 1041080189 1041080186 1041080191 1041080178 1041080177 1041080179 1041080185 1041080193 1041080197 1041080199 1041080188 1041080195 1041080198 1041080215 1041080194 1041080214 1041080260 1041080206 1041080205 1041080212 1041080204 1041080196 1041080203 1041080259 1041080202 1041080082 1041090269 1041070047 1041080216 1041080220 1041090264 1041070155 1041090263 1041090265 1041070154 1041070156 1041090268 1041090270 1041090275 1041090276 1041090279 1041090277 1041090273 1041080219 1041080207 1041090266 1041090271 1041090343 1041090340 1041090331 1041090300 1041090333 1041090338 1041090322 1041070149 1041070025 1041070147 1041080230 1041090352 1041090350 1041080226 1041080225 1041090278 1041090272 1041090280 1041090267 1041080218 1041090287 1041090291 1041090288 1041090292 1041080221 1041090283 1041090289 1041080228 1041090284 1041080230 1041090286 1041090355 1041090354 1041090359 1041090294 1041090295 1041090293 1041090303 1041090304 1041090306 1041090309 1041090297 1041090307 1041090298 1041090360 1041090308 1041090361 1041090312 1041090296 1041090329 1041080223 1041090264 1041090309 1041090304 1041090306 1041080227 1041090318 1041090324 1041090321 1041090332 1041090336 1041090337 1041090305 1041090328 1041090339 1041090345 1041090351 1041090353 1041090347 1041090290 1041090358 1041090363 1041090367 1041090366 1041",".","2106 units total (1224 units in US)","Advanced Sterilization Products (ASP) is recalling the Sterrad 100NX Sterilizer some healthcare workers detected odors/smells emanating from the 100NX Sterilizers, and it may be related to normal breakdown of the oil used in the Sterrad 200 vacuum pumps.",10/18/2013,"10/18/2013",11/20/2013,"11/20/2013"
"Devices",66547,"Ongoing","ConMed Corporation","Utica","NY","US","Voluntary: Firm Initiated","Letter","Worldwide distribution: US (Nationwide) and countries of: Canada, Germany and Italy.","Z-0331-2014","Class II","ALTRUS THERMAL TISSUE FUSION, Tissue Fusion Handpiece, 5 mm O.D., 16 cm Shaft, REF 60-9520-001, STERILE -- CONMED CORPORATION 525 FRENCH RD, UTICA, NY 13502 --- The ConMed Altrus Thermal Tissue Fusion System is comprised of a dedicated energy source and disposable handpiece used to ligate (seal) and divide (cut) blood vessels and tissue bundles that fit into the jaws of the handpiece. The Altrus System utilizes a thermal energy platform to achieve the desired clinical effect. The ConMed Altrus Thermal Tissue Fusion handpiece is a single use device which is provided sterile. The device uses scissors to parallel jaw closure mechanism with one flat jaw and one crowned jaw in which the vessels/tissues are grasped and through which pressure and heat are applied. It is a multi-functional device capable of vessel sealing, grasping and dissecting during open general surgical procedures. The two jaw sizes allow for applications in a variety of clinical environments for access in confined areas as well as large open areas.","Lot 13CHB007",,"65 handpieces (Domestic: 41 devices; Foreign: 24 devices)","The affected lots were exposed to a higher than acceptable level of particulate matter during manufacture and subsequently distributed. ConMed evaluated the potential risk that this issue could present to the patient and concluded the risk of injury to be negligible; however exposure could cause a minor, local, self correcting infection.",10/23/2013,"10/23/2013",11/27/2013,"11/27/2013"
"Devices",66547,"Ongoing","ConMed Corporation","Utica","NY","US","Voluntary: Firm Initiated","Letter","Worldwide distribution: US (Nationwide) and countries of: Canada, Germany and Italy.","Z-0332-2014","Class II","ALTRUS THERMAL TISSUE FUSION, Tissue Fusion Handpiece, 5 mm O.D., 36 cm Shaft, REF 60-9522-001, STERILE -- CONMED CORPORATION 525 FRENCH RD, UTICA, NY 13502 --- The ConMed Altrus Thermal Tissue Fusion System is comprised of a dedicated energy source and disposable handpiece used to ligate (seal) and divide (cut) blood vessels and tissue bundles that fit into the jaws of the handpiece. The Altrus System utilizes a thermal energy platform to achieve the desired clinical effect. The ConMed Altrus Thermal Tissue Fusion handpiece is a single use device which is provided sterile. The device uses scissors to parallel jaw closure mechanism with one flat jaw and one crowned jaw in which the vessels/tissues are grasped and through which pressure and heat are applied. It is a multi-functional device capable of vessel sealing, grasping and dissecting during open general surgical procedures. The two jaw sizes allow for applications in a variety of clinical environments for access in confined areas as well as large open areas.","Lot 13CHB006",,"147 handpieces (Domestic: 135 devices; Foreign: 12 devices)","The affected lots were exposed to a higher than acceptable level of particulate matter during manufacture and subsequently distributed. ConMed evaluated the potential risk that this issue could present to the patient and concluded the risk of injury to be negligible; however exposure could cause a minor, local, self correcting infection.",10/23/2013,"10/23/2013",11/27/2013,"11/27/2013"
"Food",66548,"Ongoing","Price Chopper Supermarkets","Schenectady","NY","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Price Chopper stores located in CT, VT and NY","F-0733-2014","Class II","1) 8'' Coconut Custard Pie, Net Wt 22 oz (1 lb 6oz), UPC numbers 4173523721 and 4173522453, 2) 10'' Coconut Custard Pie, Net Wt 42 oz (2 lb 10oz), UPC number 4173523713","n/a",,"36 pies sold to customers (2 pies were quarantined in store)","Products lack an ingredient statement - undeclared eggs, tree nuts, milk, wheat and soy. ",10/18/2013,"10/18/2013",12/18/2013,"12/18/2013"
"Devices",66550,"Ongoing","GE Healthcare, LLC","Waukesha","WI","US","Voluntary: Firm Initiated","Letter","Worldwide distribution: US (nationwide) including states of: AL, AZ, CA, CT,DE, FL,GA, HI, IL, IN, IA, KS, MD,MA, MI,MN, MS, O. NV, NH, NJ, NY, NC, OH, OK, OR, PA, SD, TN, TX , UT, VA, WA, WI. OUS: ALGERIA, ARGENTINA, AUSTRALIA, AUSTRIA, BELGIUM, BRAZIL, BYELO RUSSIAN, CANADA, CHINA, DENMARK, ESTONIA, FINLAND, FRANCE, GERMANY, GREECE, HONDURAS, HON KONG, HUNGARY, INDIA, INDONESIA, IRAQ, IRELAND, ISRAEL, ITALY, JAPAN, JORDAN, KOREA, KUWAIT, LATVIA, LIBYA, LITHUANIA, LUXEMBOURG, MEXICO, NETHERLANDS, NEW ZEALAND, NORWAY, POLAND, PORTUGAL, RUSSIA, SAUDI ARABIA, SINGAPORE, SOUTH AFRICA, SPAIN, SWEDEN, SWITZERLAND, TAIWAN, THAILAND, TURKEY, UKRAINE, and UNITED KINGDOM. .","Z-0270-2014","Class II","AW VolumeShare 4 (ADVANTAGE WORKSTATION 4.3.): AW VolumeShare 5 (AW VOLUMESHARE 5 WITH ANGIOVIZ OPTION): AW Server. K052995: Advantage Workstation 4.3 is a review station, which allows easy selection, review, processing and filming of multi-modality DICOM images from a variety of diagnostic imaging systems. When interpreted by a trained physician, filmed or displayed images on the AW monitor may be used as a basis for diagnosis, except in the case of mammography images. K110834: AW VolumeShare 5 is a review workstation, which allows easy selection, review, processing and filming of multi-modality DICOM images from a variety of diagnostic imaging systems. When interpreted by a trained physician, filmed or displayed images on the AW monitor may be used as a basis of diagnosis, except in the case of mammography images. K081985: AW Server is a medical software system that allows multiple users to remotely access AW applications from compatible computers on a network. The system allows networking, selection, processing and filming of multimodality DICOM images. Both the client and server software are only for use with off the shelf hardware technology that meets defined minimum specifications.","GE8 00000275710GE2 00000278632GE5 00000247368GE4 00000L026D1B92 00000L026D1C4C 0000AJ12082002 00000284797GE8 00000180601GE7 00000334600GE4 00000334599GE8 00000278633GE3 00000340261GE7 00000340260GE9 00000340259GE1 00000340258GE3 00000340257GE5 00000340256GE7 00000339696GE7 00000N11330001 00000A12174006 00000304919GE4 00000304918GE6 00000304917GE8 00000304916GE0 00000304915GE2 00000304913GE7 00000304912GE9 00000304911GE1 00000304906GE1 00000304905GE3 00000303037GE6 00000303036GE8 00000241474GE6 00000241473GE8 00000233074GE4 00000233073GE6 00000233072GE8 00000229380GE1 00000294227GE4 00000291163GE4 00000291162GE6 00000291161GE8 00000337319GE8 00000330083GE7 00000330082GE9 00000330081GE1 00000301000GE6 00000LFB4430A0 00000287043GE4 00000287042GE6 00000286722GE4 00000286721GE6 00000286720GE8 00000286719GE0 00000284798GE6 00000218123GE8 00000207772GE5 00000171129GE0 00000L06AD4DD2 00000322629GE7 00000315106GE5 00000194705GE0 00000226322GE6 00000280421GE9 00000280420GE1 00000266123GE9 00000315107GE3 00000212000GE4 00000251410GE7 00000247367GE6 00000241477GE9 00000171944GE2 00000287047GE5 00000253045GE9 00000253044GE2 00000311097GE0 00000L3A868437 00000298534GE9 00000306832GE7 00000304923GE6 00000322628GE9 00000306829GE3 00000287046GE7 00000L3A3D0C91 00000L3A3D0BFC 00000L026D1E78 00000F12320015 00000F12320012 00000F12320008 00000L02127C27 00000303031GE9 00000LA714FCD7 00000LA714FCCF 00000N13064004 00000H13021001 00000D12363003 00000J11258003 00000J11258001 0000AB12083002 00000N11159007 00000L10106002 00000L3A55FA1E 00000L3A8FD1FD 00000N11111001 00000G11103001 00000E12332008 000AA112343001 0000AA11243001 00000V10334001 00000E12332001 00000P12335002 00000N10127001 00000D11255003 00000B11131010 00000W13204010 00000T12334012 00000Q13022002 00000L13134004 00000L13134001 000000Z9309005 000000Z9309002 00000D11314001 0000AC12279003 0000AC12279001 00000P11312017 0000AF13080002 000000G9337002 00000L3A2",".","1458 (336 US, 1122 OUS)","GE Healthcare has recently become aware of a potential safety issue due to the image orientation within GSI viewer on AW products. The GSI Viewer application running on AW/Volume Share or on the AW Server when making a batch and rotating the batch group clockwise 180 degrees (Inferior to Superior) will display images in the Superior orientation. The orientation annotation on the image is correct. The concern is that the patient right/left representation is from the Superior view, which could result in a misreading of the image and misdiagnosis. ",9/19/2013,"09/19/2013",11/20/2013,"11/20/2013"
"Devices",66550,"Ongoing","GE Healthcare, LLC","Waukesha","WI","US","Voluntary: Firm Initiated","Letter","Worldwide distribution: US (nationwide) including states of: AL, AZ, CA, CT,DE, FL,GA, HI, IL, IN, IA, KS, MD,MA, MI,MN, MS, O. NV, NH, NJ, NY, NC, OH, OK, OR, PA, SD, TN, TX , UT, VA, WA, WI. OUS: ALGERIA, ARGENTINA, AUSTRALIA, AUSTRIA, BELGIUM, BRAZIL, BYELO RUSSIAN, CANADA, CHINA, DENMARK, ESTONIA, FINLAND, FRANCE, GERMANY, GREECE, HONDURAS, HON KONG, HUNGARY, INDIA, INDONESIA, IRAQ, IRELAND, ISRAEL, ITALY, JAPAN, JORDAN, KOREA, KUWAIT, LATVIA, LIBYA, LITHUANIA, LUXEMBOURG, MEXICO, NETHERLANDS, NEW ZEALAND, NORWAY, POLAND, PORTUGAL, RUSSIA, SAUDI ARABIA, SINGAPORE, SOUTH AFRICA, SPAIN, SWEDEN, SWITZERLAND, TAIWAN, THAILAND, TURKEY, UKRAINE, and UNITED KINGDOM. .","Z-0270-2014","Class II","AW VolumeShare 4 (ADVANTAGE WORKSTATION 4.3.): AW VolumeShare 5 (AW VOLUMESHARE 5 WITH ANGIOVIZ OPTION): AW Server. K052995: Advantage Workstation 4.3 is a review station, which allows easy selection, review, processing and filming of multi-modality DICOM images from a variety of diagnostic imaging systems. When interpreted by a trained physician, filmed or displayed images on the AW monitor may be used as a basis for diagnosis, except in the case of mammography images. K110834: AW VolumeShare 5 is a review workstation, which allows easy selection, review, processing and filming of multi-modality DICOM images from a variety of diagnostic imaging systems. When interpreted by a trained physician, filmed or displayed images on the AW monitor may be used as a basis of diagnosis, except in the case of mammography images. K081985: AW Server is a medical software system that allows multiple users to remotely access AW applications from compatible computers on a network. The system allows networking, selection, processing and filming of multimodality DICOM images. Both the client and server software are only for use with off the shelf hardware technology that meets defined minimum specifications.","001 00000L10351002 00000C10363001 00000U11174002 00000U11174001 00000L10351003 00000S11287002 00000S11287001 00000V10245006 00000N11172001 00000S11222002 00000T12333001 00000S11222006 00000N13163002 00000L13122001 00000V10245001 00000T12334008 00000T12334005 00000X11354003 00000R13025002 00000P11146002 00000R10250001 00000M13123010 00000M13123009 00000M13123008 00000M13123007 00000S11222005 00000S11222003 0000AB10235006 00000N11028004 00000N11159008 00000N11159002 00000R11166005 00000R11166001 00000N11159006 00000H11147006 00000N12146004 00000N12146003 00000T13081001 0000AE11203001 00000R11027002 00000K13008003 00000K13008001 0000AB10235002 00000W11112005 00000R11166003 00000R11166002 0000AJ12167002 0000AG12165002 00000M13046004 00000S12349001 00000P13042002 00000L13171001 00000F12030004 00000F12030001 00000P11312011 00000P11312006 00000R13017001 00000K12097001 0000AF12258001 00000Z12251002 00000P12242005 0000AB10235003 00000N10260002 00000T12032010 00000Q12067001 00000V10245003 00000T10291002 00000N10260001 00000G10307001 00000L3A9C89CE 0000AL12144006 0000AL12144003 00000N12146012 00000N12146005 00000W10349002 00000M11265005 00000M11265003 00000X11354002 00000V11083001 0000AE11234001 0000AA11243003 00000R11202002 00000R11202001 00000Q11173004 00000Q11173003 00000G11175002 00000X13107002 00000W13115003 00000P13087002 00000G13078001 00000Z12158001 00000M12157004 00000M12157003 00000Z12166003 0000AC13154001 0000AA11243002 00000C12070001 0000AF13080001 00000G13078004 0000AC13154002 00000W11328005 00000W11328007 0000AD12125006 0000AC12130004 S082421120267A 0S082421120267 00000L3A4817AE 00000W10125001 00000R11042001 00000M11045002 00000L10351006 00000L13023001 00000N11105001 00000L3A620C24 00000W12346001 00000W11328006 00000W11328004 00000N12146002 0000AB12083003 00000Z12093002 00000Z12093001 00000R12086009 00000W13115007 00000P13170002 00000B11095001 00000P11312016 00000M13046002 00000Y112",".","1458 (336 US, 1122 OUS)","GE Healthcare has recently become aware of a potential safety issue due to the image orientation within GSI viewer on AW products. The GSI Viewer application running on AW/Volume Share or on the AW Server when making a batch and rotating the batch group clockwise 180 degrees (Inferior to Superior) will display images in the Superior orientation. The orientation annotation on the image is correct. The concern is that the patient right/left representation is from the Superior view, which could result in a misreading of the image and misdiagnosis. ",9/19/2013,"09/19/2013",11/20/2013,"11/20/2013"
"Devices",66550,"Ongoing","GE Healthcare, LLC","Waukesha","WI","US","Voluntary: Firm Initiated","Letter","Worldwide distribution: US (nationwide) including states of: AL, AZ, CA, CT,DE, FL,GA, HI, IL, IN, IA, KS, MD,MA, MI,MN, MS, O. NV, NH, NJ, NY, NC, OH, OK, OR, PA, SD, TN, TX , UT, VA, WA, WI. OUS: ALGERIA, ARGENTINA, AUSTRALIA, AUSTRIA, BELGIUM, BRAZIL, BYELO RUSSIAN, CANADA, CHINA, DENMARK, ESTONIA, FINLAND, FRANCE, GERMANY, GREECE, HONDURAS, HON KONG, HUNGARY, INDIA, INDONESIA, IRAQ, IRELAND, ISRAEL, ITALY, JAPAN, JORDAN, KOREA, KUWAIT, LATVIA, LIBYA, LITHUANIA, LUXEMBOURG, MEXICO, NETHERLANDS, NEW ZEALAND, NORWAY, POLAND, PORTUGAL, RUSSIA, SAUDI ARABIA, SINGAPORE, SOUTH AFRICA, SPAIN, SWEDEN, SWITZERLAND, TAIWAN, THAILAND, TURKEY, UKRAINE, and UNITED KINGDOM. .","Z-0270-2014","Class II","AW VolumeShare 4 (ADVANTAGE WORKSTATION 4.3.): AW VolumeShare 5 (AW VOLUMESHARE 5 WITH ANGIOVIZ OPTION): AW Server. K052995: Advantage Workstation 4.3 is a review station, which allows easy selection, review, processing and filming of multi-modality DICOM images from a variety of diagnostic imaging systems. When interpreted by a trained physician, filmed or displayed images on the AW monitor may be used as a basis for diagnosis, except in the case of mammography images. K110834: AW VolumeShare 5 is a review workstation, which allows easy selection, review, processing and filming of multi-modality DICOM images from a variety of diagnostic imaging systems. When interpreted by a trained physician, filmed or displayed images on the AW monitor may be used as a basis of diagnosis, except in the case of mammography images. K081985: AW Server is a medical software system that allows multiple users to remotely access AW applications from compatible computers on a network. The system allows networking, selection, processing and filming of multimodality DICOM images. Both the client and server software are only for use with off the shelf hardware technology that meets defined minimum specifications.","006 00000Q13022004 00000G10271002 00000G10271001 00000F10281001 0000AC12277003 0000AC12277001 00000M13123012 00000J13175001 00000U12263003 00000U12263002 00000A12174020 00000LA70A4A10 00000L3A5F3C9C 0000AL12233002 0000AL12233001 00000L020E0A85 0000AB12018004 00000Z13168003 00000Z13168002 0000AD12269003 0000AD12269002 00000LE4B6A1CA 00000L3AB2DE60 00000P11312012 0000AL12144002 000000G9337008 0000AM12208001 0000AP12123001 0000AQ11291001 00000T12333004 00000L3A73153D 00000P11312019 00000H13058001 0000AG12118006 00000X13036003 00000W13204008 0000AM12222004 0000AM12222003 00000A12219002 00000A12219001 00000R12086007 00000G13078002 00000G13078005 00000Z12251001 0000AP12123002 00000L02577B48 000000Z9350001 0000AE11294002 00000M13046005 00000LA712358B 00000W10202001 00000H10098001 00000A10194004 00000A10194003 00000A10194002 00000X13036001 00000T13044001 00000R13025001 00000Q13022007 00000P13088001 00000N13024002 00000L13171002 00000G13078003 0000AM12222002 00000LA70A48C3 0000AP12123004 0000AL12144004 00000L3A7315C1 0000AX12262003 0000AM12261001 00000S11020004 00000S11020001 00000N10337018 00000L3A5BF838 00000L3A79AB03 00000L3A5BF827 00000E10336003 00000L3A5BF84E 00000L3A75873B 00000L3A5BF911 00000L3A9CCE94 00000L3A77E646 00000N12146001 00000L8B19A930 0000AG12118002 0000AL12142001 00000X13036002 00000Y12317002 0000AD12202004 0000AC12353003 0000AC12353002 00000L3AB68E28 0000AJ12082001 0000AH12080001 0000AC12353001 00000L0257B583 00000M12048003 00000E12332006 000000L9343010 00000K13143003 00000K13143002 00000K13143001 00000N13024001 00000L10351001 00000H10085001 00000E12332010 0000AQ12290001 0000AN11298006 0000AD12125001 00000L3A5249E5 00000F12320001 00000X12244001 0000AE11234004 0000AD13072001 00000T13073003 00000T13073001 00000Q13074001 00000V10243002 00000V10243001 00000D10232001 00000Q13022006 00000N13064005 00000N13064001 00000N12348004 00000N10127004 00000J13063002 0000AB13113001 00000E123",".","1458 (336 US, 1122 OUS)","GE Healthcare has recently become aware of a potential safety issue due to the image orientation within GSI viewer on AW products. The GSI Viewer application running on AW/Volume Share or on the AW Server when making a batch and rotating the batch group clockwise 180 degrees (Inferior to Superior) will display images in the Superior orientation. The orientation annotation on the image is correct. The concern is that the patient right/left representation is from the Superior view, which could result in a misreading of the image and misdiagnosis. ",9/19/2013,"09/19/2013",11/20/2013,"11/20/2013"
"Devices",66550,"Ongoing","GE Healthcare, LLC","Waukesha","WI","US","Voluntary: Firm Initiated","Letter","Worldwide distribution: US (nationwide) including states of: AL, AZ, CA, CT,DE, FL,GA, HI, IL, IN, IA, KS, MD,MA, MI,MN, MS, O. NV, NH, NJ, NY, NC, OH, OK, OR, PA, SD, TN, TX , UT, VA, WA, WI. OUS: ALGERIA, ARGENTINA, AUSTRALIA, AUSTRIA, BELGIUM, BRAZIL, BYELO RUSSIAN, CANADA, CHINA, DENMARK, ESTONIA, FINLAND, FRANCE, GERMANY, GREECE, HONDURAS, HON KONG, HUNGARY, INDIA, INDONESIA, IRAQ, IRELAND, ISRAEL, ITALY, JAPAN, JORDAN, KOREA, KUWAIT, LATVIA, LIBYA, LITHUANIA, LUXEMBOURG, MEXICO, NETHERLANDS, NEW ZEALAND, NORWAY, POLAND, PORTUGAL, RUSSIA, SAUDI ARABIA, SINGAPORE, SOUTH AFRICA, SPAIN, SWEDEN, SWITZERLAND, TAIWAN, THAILAND, TURKEY, UKRAINE, and UNITED KINGDOM. .","Z-0270-2014","Class II","AW VolumeShare 4 (ADVANTAGE WORKSTATION 4.3.): AW VolumeShare 5 (AW VOLUMESHARE 5 WITH ANGIOVIZ OPTION): AW Server. K052995: Advantage Workstation 4.3 is a review station, which allows easy selection, review, processing and filming of multi-modality DICOM images from a variety of diagnostic imaging systems. When interpreted by a trained physician, filmed or displayed images on the AW monitor may be used as a basis for diagnosis, except in the case of mammography images. K110834: AW VolumeShare 5 is a review workstation, which allows easy selection, review, processing and filming of multi-modality DICOM images from a variety of diagnostic imaging systems. When interpreted by a trained physician, filmed or displayed images on the AW monitor may be used as a basis of diagnosis, except in the case of mammography images. K081985: AW Server is a medical software system that allows multiple users to remotely access AW applications from compatible computers on a network. The system allows networking, selection, processing and filming of multimodality DICOM images. Both the client and server software are only for use with off the shelf hardware technology that meets defined minimum specifications.","006 00000H11027003 00000H11027002 00000H11027001 00000E10336009 00000E10336007 00000E10336006 00000E10336005 0000ZA12156001 00000Y12172004 00000E12332016 00000E12332015 00000E12332014 00000E12332012 00000E12332011 00000E12332002 00000Z11074002 0000AK12313002 0000AK12313001 0000AB10126002 00000T10123004 00000T10123002 00000T10123001 00000H10028003 00000LE23E65BE 00000L3A3C7CDB 0000AS12310002 00000F10229002 00000F10229001 000000G9337012 0000AS12310001 00000X12255001 00000L3A6CE9F2 00000M10189003 00000M10189002 00000J10208004 00000J10208001 00000L3A2AE16C 00000L3A330990 0000AL12142002 0000AG12137002 0000AG12137001 00000Z11074001 00000V11073004 00000V11073003 00000S13183004 00000S13183003 00000S13183002 00000S11020005 00000R12115002 00000R12115001 00000N11111002 00000N11105004 00000L12114001 00000L11098001 00000J13127001 00000J11077005 00000B11131011 00000B11131005 000000G9337017 0000AC12277002 00000W11101003 00000R11031002 00000R11027001 00000ZA9324001 00000U10061001 00000T10071001 00000M10075002 00000M10075001 00000LA8CEAF88 000000G9337020 0000AB11266003 0000AB11266002 0000AB11266001 00000K11179002 00000K11179001 0000AD12125008 0000AD12125007 0000AD12125005 00000T11061002 000000L9343005 00000K11117001 00000H11147005 00000H11147004 00000H11147001 00000M12157001 00000L13134009 00000L13134007 00000L13134006 00000S11020002 00000R11020006 00000R11020004 00000R11020003 00000J11024005 00000J11024004 00000J11024003 00000J11024002 00000P11278001 00000K11259005 00000K11259004 00000C10256003 00000C10256002 00000C10256001 00000L3A6CEB46 00000S13183001 0000AB10126004 0000AB10126003 00000N10127003 00000M10225001 00000J10208002 00000A10194005 00000J10215003 00000J10215002 00000L3A2544FB 00000L02546F3B 00000Z13168004 00000LA715C6B3 00000X11362002 00000J12026001 00000J12025011 00000J12025010 00000J12025009 00000J12025003 00000J12025002 0000AV12283003 0000AQ12290002 0000AL12296003 0000AL12296002 0000AL122",".","1458 (336 US, 1122 OUS)","GE Healthcare has recently become aware of a potential safety issue due to the image orientation within GSI viewer on AW products. The GSI Viewer application running on AW/Volume Share or on the AW Server when making a batch and rotating the batch group clockwise 180 degrees (Inferior to Superior) will display images in the Superior orientation. The orientation annotation on the image is correct. The concern is that the patient right/left representation is from the Superior view, which could result in a misreading of the image and misdiagnosis. ",9/19/2013,"09/19/2013",11/20/2013,"11/20/2013"
"Devices",66550,"Ongoing","GE Healthcare, LLC","Waukesha","WI","US","Voluntary: Firm Initiated","Letter","Worldwide distribution: US (nationwide) including states of: AL, AZ, CA, CT,DE, FL,GA, HI, IL, IN, IA, KS, MD,MA, MI,MN, MS, O. NV, NH, NJ, NY, NC, OH, OK, OR, PA, SD, TN, TX , UT, VA, WA, WI. OUS: ALGERIA, ARGENTINA, AUSTRALIA, AUSTRIA, BELGIUM, BRAZIL, BYELO RUSSIAN, CANADA, CHINA, DENMARK, ESTONIA, FINLAND, FRANCE, GERMANY, GREECE, HONDURAS, HON KONG, HUNGARY, INDIA, INDONESIA, IRAQ, IRELAND, ISRAEL, ITALY, JAPAN, JORDAN, KOREA, KUWAIT, LATVIA, LIBYA, LITHUANIA, LUXEMBOURG, MEXICO, NETHERLANDS, NEW ZEALAND, NORWAY, POLAND, PORTUGAL, RUSSIA, SAUDI ARABIA, SINGAPORE, SOUTH AFRICA, SPAIN, SWEDEN, SWITZERLAND, TAIWAN, THAILAND, TURKEY, UKRAINE, and UNITED KINGDOM. .","Z-0270-2014","Class II","AW VolumeShare 4 (ADVANTAGE WORKSTATION 4.3.): AW VolumeShare 5 (AW VOLUMESHARE 5 WITH ANGIOVIZ OPTION): AW Server. K052995: Advantage Workstation 4.3 is a review station, which allows easy selection, review, processing and filming of multi-modality DICOM images from a variety of diagnostic imaging systems. When interpreted by a trained physician, filmed or displayed images on the AW monitor may be used as a basis for diagnosis, except in the case of mammography images. K110834: AW VolumeShare 5 is a review workstation, which allows easy selection, review, processing and filming of multi-modality DICOM images from a variety of diagnostic imaging systems. When interpreted by a trained physician, filmed or displayed images on the AW monitor may be used as a basis of diagnosis, except in the case of mammography images. K081985: AW Server is a medical software system that allows multiple users to remotely access AW applications from compatible computers on a network. The system allows networking, selection, processing and filming of multimodality DICOM images. Both the client and server software are only for use with off the shelf hardware technology that meets defined minimum specifications.","Mfg Lot or Serial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ealthcare has recently become aware of a potential safety issue due to the image orientation within GSI viewer on AW products. The GSI Viewer application running on AW/Volume Share or on the AW Server when making a batch and rotating the batch group clockwise 180 degrees (Inferior to Superior) will display images in the Superior orientation. The orientation annotation on the image is correct. The concern is that the patient right/left representation is from the Superior view, which could result in a misreading of the image and misdiagnosis. ",9/19/2013,"09/19/2013",11/20/2013,"11/20/2013"
"Devices",66550,"Ongoing","GE Healthcare, LLC","Waukesha","WI","US","Voluntary: Firm Initiated","Letter","Worldwide distribution: US (nationwide) including states of: AL, AZ, CA, CT,DE, FL,GA, HI, IL, IN, IA, KS, MD,MA, MI,MN, MS, O. NV, NH, NJ, NY, NC, OH, OK, OR, PA, SD, TN, TX , UT, VA, WA, WI. OUS: ALGERIA, ARGENTINA, AUSTRALIA, AUSTRIA, BELGIUM, BRAZIL, BYELO RUSSIAN, CANADA, CHINA, DENMARK, ESTONIA, FINLAND, FRANCE, GERMANY, GREECE, HONDURAS, HON KONG, HUNGARY, INDIA, INDONESIA, IRAQ, IRELAND, ISRAEL, ITALY, JAPAN, JORDAN, KOREA, KUWAIT, LATVIA, LIBYA, LITHUANIA, LUXEMBOURG, MEXICO, NETHERLANDS, NEW ZEALAND, NORWAY, POLAND, PORTUGAL, RUSSIA, SAUDI ARABIA, SINGAPORE, SOUTH AFRICA, SPAIN, SWEDEN, SWITZERLAND, TAIWAN, THAILAND, TURKEY, UKRAINE, and UNITED KINGDOM. .","Z-0270-2014","Class II","AW VolumeShare 4 (ADVANTAGE WORKSTATION 4.3.): AW VolumeShare 5 (AW VOLUMESHARE 5 WITH ANGIOVIZ OPTION): AW Server. K052995: Advantage Workstation 4.3 is a review station, which allows easy selection, review, processing and filming of multi-modality DICOM images from a variety of diagnostic imaging systems. When interpreted by a trained physician, filmed or displayed images on the AW monitor may be used as a basis for diagnosis, except in the case of mammography images. K110834: AW VolumeShare 5 is a review workstation, which allows easy selection, review, processing and filming of multi-modality DICOM images from a variety of diagnostic imaging systems. When interpreted by a trained physician, filmed or displayed images on the AW monitor may be used as a basis of diagnosis, except in the case of mammography images. K081985: AW Server is a medical software system that allows multiple users to remotely access AW applications from compatible computers on a network. The system allows networking, selection, processing and filming of multimodality DICOM images. Both the client and server software are only for use with off the shelf hardware technology that meets defined minimum specifications.","002 00000N10337007 0000AD10244001 00000F12030005 0000AC12279006 00000U11174003 0000AM12159001 00000U12104001 0000AC12130001 000000G9337009 00000A10194001 00000T11124001 00000N11125001 000000G9337010 0000AV12283001 0000AM12303005 0000AC12279005 00000U12263001 00000N11159003 00000E12332013 00000U10259001 00000T10294001 00000J10293001 00000R10105001 00000R12086006 0000AC13154005 00000R11166004 00000Q11152003 00000Q11152002 00000L11150001 00000H11147007 00000H11147003 00000H11147002 00000F11151001 00000J10113001 00000U11189001 00000E12332005 00000J13032003 00000J13032001 0000AH13150002 00000P13170001 00000S11020008 00000S11020007 00000S11020006 00000N11019001 00000P11312013 0000AC13154004 0000AE11234003 00000Q11048001 000000L9343008 00000G11175001 00000W12046002 00000W12046001 00000W11328008 00000T12334010 00000T12334009 00000S11081003 00000P11312010 00000W11328001 00000M11265004 00000H10028001 00000W13204009 00000W13204006 00000W13204005 00000W13204004 00000LA70D10E6 00000M10162002 00000G10161003 00000F10173001 00000Q11152001 00000N11330003 00000M11363001 00000Q11048002 000000L9343006 0000AX12262005 0000AX12262004 0000AE12041002 00000Q11060005 00000Q11060003 00000E10336010 00000E10336004 00000A10299005 00000A10299004 0000AQ11291002 0000AN11298002 000000G9337014 00000L3A5249C5 000000L9343002 00000W13028002 00000L10333003 00000L10333002 00000L10333001 00000H12059001 0000AN11298010 0000AN11298009 0000AL12142013 00000N10337011 0000AM12222007 0000AM12222006 00000J12025008 00000J12025007 0000AE12009001 00000P11312002 00000V11143003 00000V11143002 00000U10061002 00000P11146001 00000E10083003 00000E10083002 00000E10083001 00000Z11074003 00000N11028003 0000AF12285001 00000P11312008 00000B11131008 00000LA709D844 000000G9337005 0000AL12145002 0000AL12144007 0000AL12144001 000000L9343007 00000R11055001 00000P10008001 0000AH13150004 0000AH13150003 00000J10208003 00000X13036005 00000F10229004 00000F102",".","1458 (336 US, 1122 OUS)","GE Healthcare has recently become aware of a potential safety issue due to the image orientation within GSI viewer on AW products. The GSI Viewer application running on AW/Volume Share or on the AW Server when making a batch and rotating the batch group clockwise 180 degrees (Inferior to Superior) will display images in the Superior orientation. The orientation annotation on the image is correct. The concern is that the patient right/left representation is from the Superior view, which could result in a misreading of the image and misdiagnosis. ",9/19/2013,"09/19/2013",11/20/2013,"11/20/2013"
"Devices",66551,"Ongoing","Synthes USA HQ, Inc.","West Chester","PA","US","Voluntary: Firm Initiated","Letter","Worldwided Distribution: USA (nationwide) including IL, MO, TX, WA and Internationally to Canada and Switzerland.","Z-0393-2014","Class II","Synthes Material Mix (Adjustable Cervical Distractor-Right, Matrix Distractor Rack, T-PAL Spacer Remover, Implant Inserter) Synthes Material Mix: Adjustable Cervical Distractor-Right is used to distract spine segment. Matrix Distractor Rack is used to distract the interbody disc space. T-PAL Spacer Remover is used to remove T-PAL spacer. Implant Inserter is used to insert the ProDisc implant.","part no. 396.396 (lot nos. T989765 and T989780), part no. 03.632.087 (lotT987270), part no. 03.812.005 (lot nos. T987734, T988931, and T987623), and part no. 03.820.129 (lot no. T988206). ",".","approximately 44","One material batch used for production of the affected parts of the Synthes Material Mix were mixed in with an incorrect material with a lower than specified hardness and corrosion resistance. ",10/15/2013,"10/15/2013",12/4/2013,"12/04/2013"
"Devices",66552,"Ongoing","Synthes USA HQ, Inc.","West Chester","PA","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution - USA (nationwide) and Internationally to Mexico and Canada.","Z-0369-2014","Class II","Synthes Titanium Trochanteric Fixation Nail (TFN)-Helical Blade Synthes Titanium Trochanteric Fixation Nail (TFN)-Helical Blade is used to treat stable and unstable fractures of the proximal femur including pertrochanteric fractures, intertrochanteric fractures, basal neck fractures, and combinations thereof. The long TFN is additionally indicated for subtrochanteric fractures, pertrochanteric fractures associated with shaft fractures, pathologic fractures (including prophylactic use) in both trochanteric and diaphyseal regions, long subtrochanteric fractures, proximal or distal non-unions, malunions, and revisions.","part nos. 456.300-456.310 & 456.650, 456.300S-456.310S & 456.650S, with lot nos. 561864 through 7423581",,"350195","A potential exists for non conforming Synthes Titanium Trochanteric Fixation Nail (TFN)-Helical Blades to be distributed. ",10/3/2013,"10/03/2013",11/27/2013,"11/27/2013"
"Food",66553,"Ongoing","ProThera, Inc.","Reno","NV","US","Voluntary: Firm Initiated","Letter","US and Australia, Azerbaijan, Brazil, Canada, Germany, Great Britain, Hong Kong, Ireland (Eire, Japan, Malaysia, Malta, Mexico, New Zealand, Panama, Philippines, Russia, South Korea, Spain, Switzerland, Thailand.","F-0159-2014","Class II","Klaire Labs Vital-Zymes Chewable; Comprehensive Enzyme Supplement; 180 Chewable tablets. UPC 7 09616 0218 5 Manufactured by ProThera, Inc., , Klaire Labs is a division of ProThera Reno, NV 89521","Lot F3990 and C3516",".","82,746 lot F3990 and 988.200 of lot C3516.","ProThera was notified by enzymes provided by Specialty Enzymes within the last 3-6 months may be contaminated with chloramphenicol.",10/10/2013,"10/10/2013",11/20/2013,"11/20/2013"
"Food",66553,"Ongoing","ProThera, Inc.","Reno","NV","US","Voluntary: Firm Initiated","Letter","US and Australia, Azerbaijan, Brazil, Canada, Germany, Great Britain, Hong Kong, Ireland (Eire, Japan, Malaysia, Malta, Mexico, New Zealand, Panama, Philippines, Russia, South Korea, Spain, Switzerland, Thailand.","F-0160-2014","Class II","Klaire Labs Vital-Zymes complete; Comprehensive Enzyme Supplement; 120 Vegetarian tablets. UPC 790616310005 Manufactured by ProThera, Inc., , Klaire Labs is a division of ProThera Reno, NV 89521","Lot #'s 0613110, 0513156 and 0513157",".","187,941 lot 0613110; 491.232 lot 0513156 and 504864 lot 0513157","ProThera was notified by enzymes provided by Specialty Enzymes within the last 3-6 months may be contaminated with chloramphenicol.",10/10/2013,"10/10/2013",11/20/2013,"11/20/2013"
"Food",66553,"Ongoing","ProThera, Inc.","Reno","NV","US","Voluntary: Firm Initiated","Letter","US and Australia, Azerbaijan, Brazil, Canada, Germany, Great Britain, Hong Kong, Ireland (Eire, Japan, Malaysia, Malta, Mexico, New Zealand, Panama, Philippines, Russia, South Korea, Spain, Switzerland, Thailand.","F-0162-2014","Class II","Klaire Labs Interfase Plus; Enzyme Supplement; 120 Vegetarian capsules bottles. UPC 7 09616 01228 4 Manufactured by ProThera, Inc., , Klaire Labs is a division of ProThera Reno, NV 89521 Notation: Product #6 Clean Cut Enzyme wasn't entered into RES because the product never left the warehouse.","Lot #'s 0913039, 0913040, and 0413085",".",,"ProThera was notified by enzymes provided by Specialty Enzymes within the last 3-6 months may be contaminated with chloramphenicol.",10/10/2013,"10/10/2013",11/20/2013,"11/20/2013"
"Food",66553,"Ongoing","ProThera, Inc.","Reno","NV","US","Voluntary: Firm Initiated","Letter","US and Australia, Azerbaijan, Brazil, Canada, Germany, Great Britain, Hong Kong, Ireland (Eire, Japan, Malaysia, Malta, Mexico, New Zealand, Panama, Philippines, Russia, South Korea, Spain, Switzerland, Thailand.","F-0161-2014","Class II","Klaire Labs Interfase; Enzyme Supplement; Packaged in 60 and 120 Vegetarian capsules bottles. UPC 60 ct.- 7 0961 012270 7; UPc 120 ct. - 7 09616-01229 1 Manufactured by ProThera, Inc., , Klaire Labs is a division of ProThera Reno, NV 89521","Lot #' 313127",".","243,851","ProThera was notified by enzymes provided by Specialty Enzymes within the last 3-6 months may be contaminated with chloramphenicol.",10/10/2013,"10/10/2013",11/20/2013,"11/20/2013"
"Food",66553,"Ongoing","ProThera, Inc.","Reno","NV","US","Voluntary: Firm Initiated","Letter","US and Australia, Azerbaijan, Brazil, Canada, Germany, Great Britain, Hong Kong, Ireland (Eire, Japan, Malaysia, Malta, Mexico, New Zealand, Panama, Philippines, Russia, South Korea, Spain, Switzerland, Thailand.","F-0158-2014","Class II","Serralase Enzyme Supplements; Packaged in 90 and 180 tablet bottled UPC - 90 count: 8 28054 00542 6 UPC- 180 count 8 28054 00149 7; Manufactured by: ProThera, Inc., Reno, NV 89521","Lot F3994",".","27,480 ","ProThera was notified by enzymes provided by Specialty Enzymes within the last 3-6 months may be contaminated with chloramphenicol.",10/10/2013,"10/10/2013",11/20/2013,"11/20/2013"
"Biologics",66555,"Terminated","Central California Blood Center","Fresno","CA","US","Voluntary: Firm Initiated","E-Mail","Austria; NJ","B-0106-14","Class II","Blood and Blood Products for Reprocessing","3510406",".","1 unit","Blood products, collected from a donor who was at risk for variant Creutzfeldt-Jakob disease (vCJD), were distributed.",9/11/2013,"09/11/2013",12/4/2013,"12/04/2013"
"Biologics",66555,"Terminated","Central California Blood Center","Fresno","CA","US","Voluntary: Firm Initiated","E-Mail","Austria; NJ","B-0105-14","Class II","Red Blood Cells Leukocytes Reduced","3510406",".","1 unit","Blood products, collected from a donor who was at risk for variant Creutzfeldt-Jakob disease (vCJD), were distributed.",9/11/2013,"09/11/2013",12/4/2013,"12/04/2013"
"Biologics",66556,"Terminated","Central California Blood Center","Fresno","CA","US","Voluntary: Firm Initiated","Telephone","CA","B-0104-14","Class III","Red Blood Cells Leukocytes Reduced","W115913202325; W115913202324 ",".","2 units","Blood products, collected using a machine for which daily quality control testing was not performed, were distributed.",8/30/2013,"08/30/2013",12/4/2013,"12/04/2013"
"Food",66557,"Ongoing","Apex Energetics","Irvine","CA","US","Voluntary: Firm Initiated","Letter","Nationwide in US and worldwide to Canada, United Kingdom","F-0142-2014","Class II","SuperDigestZyme (Z22), Plant Enzyme and Cofactor Dietary Supplement, 100 tablets","Lot# 303008, 304062, 306042.",".","4586 units","Apex Energetics is recalling GlutenFlam, SuperDigestZyme, LGS-Zyme, and RepairVite because they may contain trace amounts of the antibiotic chloramphenicol. The dietary supplements on recall contain enzymes that are on recall by Specialty Enzymes Biotechnology, a raw material supplier, because it contains chloramphenicol.",10/21/2013,"10/21/2013",11/20/2013,"11/20/2013"
"Food",66557,"Ongoing","Apex Energetics","Irvine","CA","US","Voluntary: Firm Initiated","Letter","Nationwide in US and worldwide to Canada, United Kingdom","F-0143-2014","Class II","LGS-Zyme (Z12), Enzyme-Based Multivitamin & Amino Acid Dietary Supplement, 120 Capsules","Lot# 130444",".","292 units","Apex Energetics is recalling GlutenFlam, SuperDigestZyme, LGS-Zyme, and RepairVite because they may contain trace amounts of the antibiotic chloramphenicol. The dietary supplements on recall contain enzymes that are on recall by Specialty Enzymes Biotechnology, a raw material supplier, because it contains chloramphenicol.",10/21/2013,"10/21/2013",11/20/2013,"11/20/2013"
"Food",66557,"Ongoing","Apex Energetics","Irvine","CA","US","Voluntary: Firm Initiated","Letter","Nationwide in US and worldwide to Canada, United Kingdom","F-0141-2014","Class II","GlutenFlam (K-52) Enzyme & Bioflavonoid Dietary Supplement, 60 vegetarian capsules","Lot # 303025, 305038",".","10,403 units","Apex Energetics is recalling GlutenFlam, SuperDigestZyme, LGS-Zyme, and RepairVite because they may contain trace amounts of the antibiotic chloramphenicol. The dietary supplements on recall contain enzymes that are on recall by Specialty Enzymes Biotechnology, a raw material supplier, because it contains chloramphenicol.",10/21/2013,"10/21/2013",11/20/2013,"11/20/2013"
"Food",66557,"Ongoing","Apex Energetics","Irvine","CA","US","Voluntary: Firm Initiated","Letter","Nationwide in US and worldwide to Canada, United Kingdom","F-0144-2014","Class II","RepairVite (K63), Enzyme-Based Herbal & Amino Acid Dietary Supplement Powder, Caramel Flavor, Net Wt. 0.34 lb (155g)","Lot# 302048 304003 306007 ",".","8117 units","Apex Energetics is recalling GlutenFlam, SuperDigestZyme, LGS-Zyme, and RepairVite because they may contain trace amounts of the antibiotic chloramphenicol. The dietary supplements on recall contain enzymes that are on recall by Specialty Enzymes Biotechnology, a raw material supplier, because it contains chloramphenicol.",10/21/2013,"10/21/2013",11/20/2013,"11/20/2013"
"Devices",66558,"Ongoing","Restoration Robotics","San Jose","CA","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution - USA Nationwide in the countries of: Korea, Japan, Singapore, Thailand, United Kingdom, Canada, and Taiwan.","Z-0354-2014","Class II","ARTAS Disposable Kit ( Contains Skin Tensioner FP-45384; Inner Needle with Vacuum Tube FP-45385; Dissection Punch 4.0mm FP-23304; Saline Nose Cone FP-45387; Follicle Trap - FP-23306 and Non-sterile Disposable Clinical Kit FP -23267): and ARTAS Disposable Kits, 18 Gauge Epsilon (Contains Disposable Kit, 18 Gauge Epsilon FP 45547 and Non-Sterile Disposable Kit FP-23267). RX. Product Usage: Skin Tensioner is applied to patients scalp during follicular harvesting during hair restoration procedure. Product applies tension to scalp to facilitate follicular extractions. ","Model number FP-45616 and FP45173",,"515 US, 315 International (all packaging configurations)","Reports of discoloration (residue) on the pins of the skin tensioner have been received by several customers. Discoloration due to insufficient cleaning of stainless steel pins during passivation process. The residue has been identified as a compound of iron and chlorine.",10/13/2013,"10/13/2013",11/27/2013,"11/27/2013"
"Devices",66558,"Ongoing","Restoration Robotics","San Jose","CA","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution - USA Nationwide in the countries of: Korea, Japan, Singapore, Thailand, United Kingdom, Canada, and Taiwan.","Z-0353-2014","Class II","Epsilon Skin Tensioner:Rx, Sterile Sterilized using Gamma. Turns Red if sterilized using Gamma; Product Usage: Skin Tensioner is applied to patients scalp during follicular harvesting during hair restoration procedure. Product applies tension to scalp to facilitate follicular extractions. ","Model number FP-45384",,"515 in US. 315 International.(included all packaging configurations)","Reports of discoloration (residue) on the pins of the skin tensioner have been received by several customers. Discoloration due to insufficient cleaning of stainless steel pins during passivation process. The residue has been identified as a compound of iron and chlorine.",10/13/2013,"10/13/2013",11/27/2013,"11/27/2013"
"Devices",66558,"Ongoing","Restoration Robotics","San Jose","CA","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution - USA Nationwide in the countries of: Korea, Japan, Singapore, Thailand, United Kingdom, Canada, and Taiwan.","Z-0355-2014","Class II","Sterile Disposable Kit ( Contains Skin Tensioner ASY-25067; Three Mark Needle Assembly ASY-25094; Nose Cone Assembly ASY-25098; Dissection 4 mm PRT-25117, follicle Trap PRT 23999): Product Usage: Skin Tensioner is applied to patients scalp during follicular harvesting during hair restoration procedure. Product applies tension to scalp to facilitate follicular extractions. ","Model number FP-45547",,"515 US, 315 International (all packaging cnfigurations)","Reports of discoloration (residue) on the pins of the skin tensioner have been received by several customers. Discoloration due to insufficient cleaning of stainless steel pins during passivation process. The residue has been identified as a compound of iron and chlorine.",10/13/2013,"10/13/2013",11/27/2013,"11/27/2013"
"Devices",66558,"Ongoing","Restoration Robotics","San Jose","CA","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution - USA Nationwide in the countries of: Korea, Japan, Singapore, Thailand, United Kingdom, Canada, and Taiwan.","Z-0356-2014","Class II","ARTAS Disposable and Reuseable Kit ( Contains Skin Tensioner FP-45384; Inner Needle with Vacuum Tube FP-45385; dissection Punch 4.0mm FP 23304; Saline Nose Cone FP-45387; Follicle Trap FP 23306; Non-Sterile Disposable kit FP 23267 and Molded Parts, Reusable Kit FP 45538 Rx): Product Usage: Skin Tensioner is applied to patients scalp during follicular harvesting during hair restoration procedure. Product applies tension to scalp to facilitate follicular extractions. ","Model number FP-45399",,"515 US, 315 International (all Packaging configurations.","Reports of discoloration (residue) on the pins of the skin tensioner have been received by several customers. Discoloration due to insufficient cleaning of stainless steel pins during passivation process. The residue has been identified as a compound of iron and chlorine.",10/13/2013,"10/13/2013",11/27/2013,"11/27/2013"
"Food",66559,"Ongoing","Empirical Laboratories, Incorporated","Fort Collins","CO","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Distributed to ID, MN, and SC. Foreign distribution to Sweden. No military/govt/VA consignees.","F-0145-2014","Class II","All-Natural Greens Dietary Supplement; Manufactured Exclusively for NatureRich, Maple Grove, MN 55369. ","Lots: 3071520, 3071521, 3071522,03071523,3071524, 3071525, 3071526 ",".","1041","Empirical Labs is recalling certain lots of dietary supplements due to potential for adulteration with chloramphenicol.",10/21/2013,"10/21/2013",11/20/2013,"11/20/2013"
"Food",66559,"Ongoing","Empirical Laboratories, Incorporated","Fort Collins","CO","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Distributed to ID, MN, and SC. Foreign distribution to Sweden. No military/govt/VA consignees.","F-0151-2014","Class II","Empirical Labs Building Health Superfuel; 240 Capsules Dietary Supplement","Lots: 3072303 ",".","61","Empirical Labs is recalling certain lots of dietary supplements due to potential for adulteration with chloramphenicol.",10/21/2013,"10/21/2013",11/20/2013,"11/20/2013"
"Food",66559,"Ongoing","Empirical Laboratories, Incorporated","Fort Collins","CO","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Distributed to ID, MN, and SC. Foreign distribution to Sweden. No military/govt/VA consignees.","F-0147-2014","Class II","Vive Shake Up Your Health Chocolate; Made for and distributed by renewal wellness.","Lots: 3090510, 3081910 ",".","519","Empirical Labs is recalling certain lots of dietary supplements due to potential for adulteration with chloramphenicol.",10/21/2013,"10/21/2013",11/20/2013,"11/20/2013"
"Food",66559,"Ongoing","Empirical Laboratories, Incorporated","Fort Collins","CO","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Distributed to ID, MN, and SC. Foreign distribution to Sweden. No military/govt/VA consignees.","F-0155-2014","Class II","Empirical Labs Building Health Vascuzyme; 90 Capsules Dietary Supplement","Lots: 3080104 ",".","163","Empirical Labs is recalling certain lots of dietary supplements due to potential for adulteration with chloramphenicol.",10/21/2013,"10/21/2013",11/20/2013,"11/20/2013"
"Food",66559,"Ongoing","Empirical Laboratories, Incorporated","Fort Collins","CO","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Distributed to ID, MN, and SC. Foreign distribution to Sweden. No military/govt/VA consignees.","F-0146-2014","Class II","Natural Balanced Nutrition Vanilla Energy Shake Dietary Supplement; Manufactured for NatureRich, Maple Grove, MN.","Lots: 3062615",".","513","Empirical Labs is recalling certain lots of dietary supplements due to potential for adulteration with chloramphenicol.",10/21/2013,"10/21/2013",11/20/2013,"11/20/2013"
"Food",66559,"Ongoing","Empirical Laboratories, Incorporated","Fort Collins","CO","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Distributed to ID, MN, and SC. Foreign distribution to Sweden. No military/govt/VA consignees.","F-0148-2014","Class II","Empirical Labs Building Health SuperFuel Plus Mocha Flavor; Whey protein isolate (milk); Dietary Supplement","Lots: 3061708",".","62","Empirical Labs is recalling certain lots of dietary supplements due to potential for adulteration with chloramphenicol.",10/21/2013,"10/21/2013",11/20/2013,"11/20/2013"
"Food",66559,"Ongoing","Empirical Laboratories, Incorporated","Fort Collins","CO","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Distributed to ID, MN, and SC. Foreign distribution to Sweden. No military/govt/VA consignees.","F-0150-2014","Class II","Dynamite Specialty Products Tri-Mins Daily Foundation, calcium, magnesium, potassium dietary supplement; 240 Capsules; Manufactured for Dynamite Marketing, Inc, Meridian, ID 83642.","Lots: 3061705, 3072312 ",".","1,727","Empirical Labs is recalling certain lots of dietary supplements due to potential for adulteration with chloramphenicol.",10/21/2013,"10/21/2013",11/20/2013,"11/20/2013"
"Food",66559,"Ongoing","Empirical Laboratories, Incorporated","Fort Collins","CO","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Distributed to ID, MN, and SC. Foreign distribution to Sweden. No military/govt/VA consignees.","F-0157-2014","Class II","Non-GMO Ingredients Go Green Fuel for the Entire Body Dietary Supplement. All-Natural Greens Dietary Supplement. Manufactured Exclusiveley for: Hsin Ten Enterprise USA, Inc. Industry, CA 91748.","Lots: 3071520,3071521,3071522,3071523,3071524, 3071526",".","5157","Empirical Labs is recalling certain lots of dietary supplements due to potential for adulteration with chloramphenicol.",10/21/2013,"10/21/2013",11/20/2013,"11/20/2013"
"Food",66559,"Ongoing","Empirical Laboratories, Incorporated","Fort Collins","CO","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Distributed to ID, MN, and SC. Foreign distribution to Sweden. No military/govt/VA consignees.","F-0154-2014","Class II","Empirical Labs Building Health Thyroid; 90 Capsules Dietary Supplement","Lots: 3071708 ",".","22","Empirical Labs is recalling certain lots of dietary supplements due to potential for adulteration with chloramphenicol.",10/21/2013,"10/21/2013",11/20/2013,"11/20/2013"
"Food",66559,"Ongoing","Empirical Laboratories, Incorporated","Fort Collins","CO","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Distributed to ID, MN, and SC. Foreign distribution to Sweden. No military/govt/VA consignees.","F0152-2014","Class II","Empirical Labs Building Health Digesti-Zyme; 180 Capsules Dietary SupplementSupplement","Lots: 3080101 ",".","246","Empirical Labs is recalling certain lots of dietary supplements due to potential for adulteration with chloramphenicol.",10/21/2013,"10/21/2013",11/20/2013,"11/20/2013"
"Food",66559,"Ongoing","Empirical Laboratories, Incorporated","Fort Collins","CO","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Distributed to ID, MN, and SC. Foreign distribution to Sweden. No military/govt/VA consignees.","F-0149-2014","Class II","Empirical Labs Building Health SuperFuel Tropical Dietary Supplement","Lots: 3061708 ",".","62","Empirical Labs is recalling certain lots of dietary supplements due to potential for adulteration with chloramphenicol.",10/21/2013,"10/21/2013",11/20/2013,"11/20/2013"
"Food",66559,"Ongoing","Empirical Laboratories, Incorporated","Fort Collins","CO","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Distributed to ID, MN, and SC. Foreign distribution to Sweden. No military/govt/VA consignees.","F-0156-2014","Class II","Empirical Labs Building Health P&L Enzymes; 180 Capsules Dietary Supplement","Lots: 3080205 ",".","63","Empirical Labs is recalling certain lots of dietary supplements due to potential for adulteration with chloramphenicol.",10/21/2013,"10/21/2013",11/20/2013,"11/20/2013"
"Food",66559,"Ongoing","Empirical Laboratories, Incorporated","Fort Collins","CO","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Distributed to ID, MN, and SC. Foreign distribution to Sweden. No military/govt/VA consignees.","F-0153-2014","Class II","Empirical Labs Building Health Inte-Zyme; 180 Capsules Dietary Supplement","Lots: 3080109 ",".","48","Empirical Labs is recalling certain lots of dietary supplements due to potential for adulteration with chloramphenicol.",10/21/2013,"10/21/2013",11/20/2013,"11/20/2013"
"Devices",66560,"Ongoing","Philips Healthcare Informatics, Inc.","Foster City","CA","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution - USA (nationwide) and country: Canada.","Z-0269-2014","Class II","Philips brand IntelliSpace PACS 4.4, Image Management System; The system is a software package used with general purpose computing hardware to acquire, store, distribute, process and display images and associated data throughout a clinical environment. Product is manufactured and distributed by Philips Healthcare Informatics, Inc. Foster City, CA IntelliSpace PACS are image management systems intended to be used by trained professionals, including but not limited to physicians, nurses and medical technicians. The system is a software package used with general purpose computing hardware to acquire, store, distribute, process and display images and associated data throughout a clinical environment. The software performs digital image processing, measurement, communication and storage. iSite supports receiving, sending, printing, storing and displaying studies received from the following modality types via DICOM: CT, MR, NM, US, XA, PET, DX, DR, RE, RT, MG, SC, VL, as well as hospital/radiology information systems.","All units of these IntelliSpace PACS.",".","71 units","Philips Healthcare became aware of a software problem with the IntelliSpace PACS system, in that a timing issue has been identified that may result in a condition where the device does not store additional images received before processing is complete. The missing images may contain pathology which may result in a different diagnosis if they had been available at time of interpretation.",10/14/2013,"10/14/2013",11/20/2013,"11/20/2013"
"Devices",66561,"Ongoing","Mizuho America, Inc.","Union City","CA","US","Voluntary: Firm Initiated","Letter","Nationwide Distribution","Z-0378-2014","Class II","Mizuho Sugita Titanium Standard Aneurysm Clip II , Temporary Mini Type No 58 Temporary and permanent occlusion of cervical segment of cerebral aneurysms and peripheral blood vessels. They are designed for Single Use.","Product Code 17-001-58; Lot No. 29JY",".","35","Specific item numbers form Lots 27-J and 29-J of Sugita T2 Aneurysm Clips. Mini Temporary Type, are discolored.",10/10/2013,"10/10/2013",12/4/2013,"12/04/2013"
"Devices",66561,"Ongoing","Mizuho America, Inc.","Union City","CA","US","Voluntary: Firm Initiated","Letter","Nationwide Distribution","Z-0377-2014","Class II","Mizuho Sugita Titanium Standard Aneurysm Clip II , Temporary and permanent occlusion of cervical segment of cerebral aneurysms and peripheral blood vessels. They are designed for Single Use.","Product Code 17-001-56; Lot No. 27JY",".","32","Specific item numbers form Lots 27-J and 29-J of Sugita T2 Aneurysm Clips. Mini Temporary Type, are discolored.",10/10/2013,"10/10/2013",12/4/2013,"12/04/2013"
"Food",66562,"Ongoing","FoodScience Corporation","Essex Junction","VT","US","Voluntary: Firm Initiated","Letter","NJ","F-0229-2014","Class II","Florayme A Dietary Supplement for Complete Digestive Support, 90 count capsules Distributed by Wendy Huang, MD, MPH, DABMA 9 Professional Circle, Suite 212, Colts Neck, NJ 07722 ","Lot Number: 20428800 ",".","48 units"," Dietary supplements are recalled because they may contain trace amounts of the antibiotic chloramphenicol. The dietary supplements on recall contain enzymes that are on recall by Specialty Enzymes Biotechnology, a raw material supplier, because it contains chloramphenicol.",11/8/2013,"11/08/2013",12/4/2013,"12/04/2013"
"Food",66562,"Ongoing","FoodScience Corporation","Essex Junction","VT","US","Voluntary: Firm Initiated","Letter","NJ","F-0227-2014","Class II","Nutritional Frontiers Cyb Zyme- A Dietary Supplement for Complete Digestive Support 90 count ","Lot Number: 20165800",".","144 units"," Dietary supplements are recalled because they may contain trace amounts of the antibiotic chloramphenicol. The dietary supplements on recall contain enzymes that are on recall by Specialty Enzymes Biotechnology, a raw material supplier, because it contains chloramphenicol.",11/8/2013,"11/08/2013",12/4/2013,"12/04/2013"
"Food",66562,"Ongoing","FoodScience Corporation","Essex Junction","VT","US","Voluntary: Firm Initiated","Letter","NJ","F-0230-2014","Class II","Cenk Disczyme A Dietary Supplement for Complete Digestive Support, 180 count capsule Distributed by Cenk Integrated Health & Spine Services, 107 Gamma Drive Ste 100, Pittsburgh, PA 15328 ","Lot Number: 20525100 ",".","48 units"," Dietary supplements are recalled because they may contain trace amounts of the antibiotic chloramphenicol. The dietary supplements on recall contain enzymes that are on recall by Specialty Enzymes Biotechnology, a raw material supplier, because it contains chloramphenicol.",11/8/2013,"11/08/2013",12/4/2013,"12/04/2013"
"Food",66562,"Ongoing","FoodScience Corporation","Essex Junction","VT","US","Voluntary: Firm Initiated","Letter","NJ","F-0228-2014","Class II","Life Worth Living Nutriceuticals LWL Enzyme Life A Dietary Supplement for Complete Digestive Support, Distributed by Life Worth Living Nutriceuticals, 6488 Currin Drive, Orlando, Florida 32835 90 count ","Lot Number: 20525000",".","48 units"," Dietary supplements are recalled because they may contain trace amounts of the antibiotic chloramphenicol. The dietary supplements on recall contain enzymes that are on recall by Specialty Enzymes Biotechnology, a raw material supplier, because it contains chloramphenicol.",11/8/2013,"11/08/2013",12/4/2013,"12/04/2013"
"Food",66564,"Ongoing","Threshold Enterprises Ltd","Scotts Valley","CA","US","Voluntary: Firm Initiated","Letter","The product was distributed Nationwide.","F-0100-2014","Class II","Serene Science/Source Naturals brand GABA (Gamma-Aminobutyric Acid), CALM MIND, A dietary supplement, 45 Tablets, Item #: SN0237; 90 Tablets, Item #: SN0240; 180 Tablets, Item #: SN0268; Product label states, ''manufactured for Source Naturals, Inc., P.O. Box 2118, Santa Cruz, CA 95062''; and distributed by Threshold Enterprises, Ltd, Scotts Valley, CA; The product is actually manufactured by a Contract Manufacturer: Abco Laboratories, Inc., 2450 S. Watney Way, Fairfield, CA 94533 ","Item #: SN0237 - 45 Count, Lot Numbers: FG-40244, FG-40421, FG-40679; Item #: SN0240 - 90 Count, Lot Numbers: FG-40245, FG-40422, FG-40680; Item #: SN0268 -180 Count Lot Number: FG-40681; All packages have BEST BY DATE 3/21/17 ",".","3976 bottles","The firm found small piece of metal fragment in one tablet during its inspection process.",9/20/2013,"09/20/2013",11/13/2013,"11/13/2013"
"Food",66565,"Ongoing","Sunny Pine Farm","Twisp","WA","US","Voluntary: Firm Initiated","Press Release","Finished products were sold in WA only","F-0223-2014","Class II","Organic Chevre sold at Farmer's Market in plastic 6 oz tubs, vacuum-sealed with lid and label on top of tub, Sunny Pine Farm brand. Product also sold to in 2 lbs. and 3 lbs. to restaurant. Product is labeled in parts: ''***Organic Goat Dairy***Chevre***SUNNY PINE FARM***6 oz***Pasteurized Organic Goat Milk, Salt, Rennet, and Culture***Keep refrigerated***Handcrafted in Twisp, Washington 98856***.","Expiration dates of products sold to non-restaurant consignees: 10/16/2013. Expiration dates of products sold to restaurants: 10/23/13 and 11/5/13. Chevre cheese products sold at Methow Valley Farmers Market (aka Twisp Farmers Market) between 7/27/13 and 10/12/13 were NOT labeled with an expiration date.",,"121/6 oz. packages.; 2/2 lbs. packages; 11/3 lbs. packages","Sunny Pine Farm of Twisp, Washington is voluntarily recalling Organic Chevre due to possible improper pasteurization. ",10/18/2013,"10/18/2013",11/27/2013,"11/27/2013"
"Food",66565,"Ongoing","Sunny Pine Farm","Twisp","WA","US","Voluntary: Firm Initiated","Press Release","Finished products were sold in WA only","F-0226-2014","Class II","Organic Black Pepper Garlic Chevre is sold in 3 lbs. vacuum plastic bag without labels since it sold to restaurants. However, the retail label is read in parts: ''***Organic Goat Dairy***Black Pepper Garlic Chevre***6 oz***SUNNY PINE FARMS***Handcrafted in Twisp, Washington 98856***Pasteurized Organic Goat Milk, Garlic, Pepper, Salt, Rennet, and Cultures***Keep Refrigerated***''.","Expiration dates of products sold to restaurants: 10/23/13 and 11/5/13. ",,"5/3 lbs. packages","Sunny Pine Farm of Twisp, Washington is voluntarily recalling Organic Black Pepper Garlic Chevre due to possible improper pasteurization. ",10/18/2013,"10/18/2013",11/27/2013,"11/27/2013"
"Food",66565,"Ongoing","Sunny Pine Farm","Twisp","WA","US","Voluntary: Firm Initiated","Press Release","Finished products were sold in WA only","F-0224-2014","Class II","Organic Parsley Chive Chevre sold to non-restaurant in plastic 6 oz plastic tub vacuum-sealed with lid and label on top of tub, Sunny Pine Farm brand. Product sold to restaurant is in 1 lb. and 2 lbs. size. The product is labeled in parts: ''***Organic Goat Dairy***Parsley Chive Chevre***6 oz. ***SUNNY PINE FARM***Handcrafted in Twisp, Washington 98856***Pasteurized Organic Goat Milk, Salt, Parsley, Chives, Rennet, Cultures***Keep refrigerated***''","Expiration dates of products sold to non-restaurant consignees: 10/16/2013. Expiration dates of products sold to restaurants: 10/23/13 and 11/5/13. Chevre cheese products sold at Methow Valley Farmers Market (aka Twisp Farmers Market) between 7/27/13 and 10/12/13 were NOT labeled with an expiration date.",,"200/6 oz. tubs; 1/1 lb. package; 2/2 lbs. packages","Sunny Pine Farm of Twisp, Washington is voluntarily recalling Organic Parsley Chive Chevre due to possible improper pasteurization. ",10/18/2013,"10/18/2013",11/27/2013,"11/27/2013"
"Food",66565,"Ongoing","Sunny Pine Farm","Twisp","WA","US","Voluntary: Firm Initiated","Press Release","Finished products were sold in WA only","F-0225-2014","Class II","Organic Honey Lavender Chevre is sold in plastic 6 oz tubs under Sunny Pine Farm brand. The product is labeled in parts: ''***Organic Goat Dairy***Honey Lavender Chevre***6 oz.***SUNNY PINE FARM***Handcrafted in Twisp, Washington 98856***Pasteurized Organic Goat Milk, Honey, Salt, Lavender, Rennet, Cultures***Keep refrigerated***''.","Expiration dates of products sold to non-restaurant consignees: 10/16/2013. Expiration dates of products sold to restaurants: 10/23/13 and 11/5/13. Chevre cheese products sold at Methow Valley Farmers Market (aka Twisp Farmers Market) between 7/27/13 and 10/12/13 were NOT labeled with an expiration date.",,"206/6 oz. tubs.","Sunny Pine Farm of Twisp, Washington is voluntarily recalling Organic Honey Lavender Chevre due to possible improper pasteurization. ",10/18/2013,"10/18/2013",11/27/2013,"11/27/2013"
"Devices",66567,"Ongoing","Medtronic Vascular","Danvers","MA","US","Voluntary: Firm Initiated","Letter","Worldwide distribution: US (Nationwide) including states of: AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, IA, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, WA, WI, and WV; and countries of: Albania, Argentina, Australia, Austria, Belgium, Brazil, Canada, Chile, China, Colombia, Croatia, Czech Republic, Denmark, Ecuador, Egypt, Finland, France, Georgia, Germany, Greece, Guyana, Honduras, Hong Kong,Hungary, Iceland, India, Ireland, Israel, Italy, Japan, Jordan, Kuwait, Lebanon, Libya, Luxembourg, Malaysia, Mexico, Montenegro, Nepal, Netherlands, New Zealand, Nepal, Nicaragua, Norway, Oman, Poland, Portugal Puerto Rico, Qatar, Russian Federation, Saudi Arabia, Serbia, Singapore, Slovakia, South Africa, Spain, Sweden, Switzerland, Taiwan, Thailand, Tunisia, United Kingdom, Uruguay, and Yemen.","Z-0268-2014","Class I","ZINGER Steerable Guidewire; Models: LVZRLS180J, LVZRLS180S, LVZRMS180J, LVZRMS180S, LVZRXT180J, LVZRXT180S Medtronic guide wires are steerable guide wires that are used for the introduction and placement of diagnostics or interventional devices in the coronary and peripheral vasculature, and may be used to reach and cross a target lesion. Medtronic guide wires are not intended for cerebral vasculature. Medtronic steerable exchange guide wires are used to facilitate the substitution of one diagnostic or interventional device for another.","G13A00118 G13A00715 G13A00716 G13A00843 G13A00937 G13A01601 G13A01620 G13A01621 G13A01638 G13A01639 G13A01650 GV854 GW761 ",,"5","Potential for PTFE (polytetrafluroethylene) coating to delaminate and detach from Guidewire. ",10/21/2013,"10/21/2013",11/27/2013,"11/27/2013"
"Devices",66567,"Ongoing","Medtronic Vascular","Danvers","MA","US","Voluntary: Firm Initiated","Letter","Worldwide distribution: US (Nationwide) including states of: AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, IA, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, WA, WI, and WV; and countries of: Albania, Argentina, Australia, Austria, Belgium, Brazil, Canada, Chile, China, Colombia, Croatia, Czech Republic, Denmark, Ecuador, Egypt, Finland, France, Georgia, Germany, Greece, Guyana, Honduras, Hong Kong,Hungary, Iceland, India, Ireland, Israel, Italy, Japan, Jordan, Kuwait, Lebanon, Libya, Luxembourg, Malaysia, Mexico, Montenegro, Nepal, Netherlands, New Zealand, Nepal, Nicaragua, Norway, Oman, Poland, Portugal Puerto Rico, Qatar, Russian Federation, Saudi Arabia, Serbia, Singapore, Slovakia, South Africa, Spain, Sweden, Switzerland, Taiwan, Thailand, Tunisia, United Kingdom, Uruguay, and Yemen.","Z-0265-2014","Class I","ATTAIN HYBRID Guide Wire; Models: GWR419478, GWR419488, GWR419688 The Attain Hybrid guide wire is intended to aid in the placement of Medtronic transvenous left ventricular leads in the coronary vasculature.","0006752371 0006752383 0006752385 0006759937 0006759939 0006759941 0006769772 0006781453 0006781454 0006781455 0006808160 0006808161 0006808164 0006808165 0006808166 0006808167 0006831243 0006840866 0006840878 0006840879 0006866694 0006866696 0006866697 0006873688 0006873692 0006873694 ",,"1674","Potential for PTFE (polytetrafluroethylene) coating to delaminate and detach from Guidewire. ",10/21/2013,"10/21/2013",11/27/2013,"11/27/2013"
"Devices",66567,"Ongoing","Medtronic Vascular","Danvers","MA","US","Voluntary: Firm Initiated","Letter","Worldwide distribution: US (Nationwide) including states of: AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, IA, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, WA, WI, and WV; and countries of: Albania, Argentina, Australia, Austria, Belgium, Brazil, Canada, Chile, China, Colombia, Croatia, Czech Republic, Denmark, Ecuador, Egypt, Finland, France, Georgia, Germany, Greece, Guyana, Honduras, Hong Kong,Hungary, Iceland, India, Ireland, Israel, Italy, Japan, Jordan, Kuwait, Lebanon, Libya, Luxembourg, Malaysia, Mexico, Montenegro, Nepal, Netherlands, New Zealand, Nepal, Nicaragua, Norway, Oman, Poland, Portugal Puerto Rico, Qatar, Russian Federation, Saudi Arabia, Serbia, Singapore, Slovakia, South Africa, Spain, Sweden, Switzerland, Taiwan, Thailand, Tunisia, United Kingdom, Uruguay, and Yemen.","Z-0262-2014","Class I","Zinger Stainless Steel Workhorse Guidewire; Models: ZNGRLS180HJ, ZNGRLS180HS, ZNGRMS180HJ, ZNGRMS180HS, ZNGRMS180S, ZNGRS180HJ, ZNGRS180HS, ZNGRS180S Medtronic guide wires are steerable guide wires that are used for the introduction and placement of diagnostics or interventional devices in the coronary and peripheral vasculature, and may be used to reach and cross a target lesion. Medtronic guide wires are not intended for cerebral vasculature. Medtronic steerable exchange guide wires are used to facilitate the substitution of one diagnostic or interventional device for another.","G13A00123 G13A00870 G13A00910 G13A00911 G13A00920 G13A00921 G13A00931 G13A00939 G13A00940 G13A01270 G13A01271 G13A01352 G13A01354 G13A01355 G13A01477 G13A01478 G13A01622 G13A01623 G13A01624 G13A01640 G13A01641 G13A01651 GV875 GV876 GW594 GW683 GW695 ",,"1,239","Potential for PTFE (polytetrafluroethylene) coating to delaminate and detach from Guidewire. ",10/21/2013,"10/21/2013",11/27/2013,"11/27/2013"
"Devices",66567,"Ongoing","Medtronic Vascular","Danvers","MA","US","Voluntary: Firm Initiated","Letter","Worldwide distribution: US (Nationwide) including states of: AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, IA, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, WA, WI, and WV; and countries of: Albania, Argentina, Australia, Austria, Belgium, Brazil, Canada, Chile, China, Colombia, Croatia, Czech Republic, Denmark, Ecuador, Egypt, Finland, France, Georgia, Germany, Greece, Guyana, Honduras, Hong Kong,Hungary, Iceland, India, Ireland, Israel, Italy, Japan, Jordan, Kuwait, Lebanon, Libya, Luxembourg, Malaysia, Mexico, Montenegro, Nepal, Netherlands, New Zealand, Nepal, Nicaragua, Norway, Oman, Poland, Portugal Puerto Rico, Qatar, Russian Federation, Saudi Arabia, Serbia, Singapore, Slovakia, South Africa, Spain, Sweden, Switzerland, Taiwan, Thailand, Tunisia, United Kingdom, Uruguay, and Yemen.","Z-0264-2014","Class I","ProVia CROSSING GUIDEWIRE; Models: 15PROV300HS, 3PROV180HS, 3PROV180SS, 3PROV300HS, 3PROV300SS Medtronic guide wires are steerable guide wires that are used for the introduction and placement of diagnostics or interventional devices in the coronary and peripheral vasculature, and may be used to reach and cross a target lesion. Medtronic guide wires are not intended for cerebral vasculature. Medtronic steerable exchange guide wires are used to facilitate the substitution of one diagnostic or interventional device for another. ","G13A00130 G13A01300 GT414 GU543 GV117 GV118 GV121 GV381 GV382 GV919 GW768 ",,"465","Potential for PTFE (polytetrafluroethylene) coating to delaminate and detach from Guidewire. Medtronic guide wires are steerable guide wires that are used for the introduction and placement of diagnostics or interventional devices in the coronary and peripheral vasculature, and may be used to reach and cross a target lesion. Medtronic guide wires are not intended for cerebral vasculature. Medtronic steerable exchange guide wires are used to facilitate the substitution of one diagnostic or interventional device for another. ",10/21/2013,"10/21/2013",11/27/2013,"11/27/2013"
"Devices",66567,"Ongoing","Medtronic Vascular","Danvers","MA","US","Voluntary: Firm Initiated","Letter","Worldwide distribution: US (Nationwide) including states of: AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, IA, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, WA, WI, and WV; and countries of: Albania, Argentina, Australia, Austria, Belgium, Brazil, Canada, Chile, China, Colombia, Croatia, Czech Republic, Denmark, Ecuador, Egypt, Finland, France, Georgia, Germany, Greece, Guyana, Honduras, Hong Kong,Hungary, Iceland, India, Ireland, Israel, Italy, Japan, Jordan, Kuwait, Lebanon, Libya, Luxembourg, Malaysia, Mexico, Montenegro, Nepal, Netherlands, New Zealand, Nepal, Nicaragua, Norway, Oman, Poland, Portugal Puerto Rico, Qatar, Russian Federation, Saudi Arabia, Serbia, Singapore, Slovakia, South Africa, Spain, Sweden, Switzerland, Taiwan, Thailand, Tunisia, United Kingdom, Uruguay, and Yemen.","Z-0267-2014","Class I","THUNDER Steerable Guidewire; Model: LVTNDR190S Medtronic guide wires are steerable guide wires that are used for the introduction and placement of diagnostics or interventional devices in the coronary and peripheral vasculature, and may be used to reach and cross a target lesion. Medtronic guide wires are not intended for cerebral vasculature. Medtronic steerable exchange guide wires are used to facilitate the substitution of one diagnostic or interventional device for another.","G13A00116 G13A00936 GV260 GV846 ",,"1205","Potential for PTFE (polytetrafluroethylene) coating to delaminate and detach from Guidewire. ",10/21/2013,"10/21/2013",11/27/2013,"11/27/2013"
"Devices",66567,"Ongoing","Medtronic Vascular","Danvers","MA","US","Voluntary: Firm Initiated","Letter","Worldwide distribution: US (Nationwide) including states of: AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, IA, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, WA, WI, and WV; and countries of: Albania, Argentina, Australia, Austria, Belgium, Brazil, Canada, Chile, China, Colombia, Croatia, Czech Republic, Denmark, Ecuador, Egypt, Finland, France, Georgia, Germany, Greece, Guyana, Honduras, Hong Kong,Hungary, Iceland, India, Ireland, Israel, Italy, Japan, Jordan, Kuwait, Lebanon, Libya, Luxembourg, Malaysia, Mexico, Montenegro, Nepal, Netherlands, New Zealand, Nepal, Nicaragua, Norway, Oman, Poland, Portugal Puerto Rico, Qatar, Russian Federation, Saudi Arabia, Serbia, Singapore, Slovakia, South Africa, Spain, Sweden, Switzerland, Taiwan, Thailand, Tunisia, United Kingdom, Uruguay, and Yemen.","Z-0263-2014","Class I","THUNDER Extra Support Guidewire; Models: THNDR190J, THNDR190S, THNDR300J, THNDR300S Medtronic guide wires are steerable guide wires that are used for the introduction and placement of diagnostics or interventional devices in the coronary and peripheral vasculature, and may be used to reach and cross a target lesion. Medtronic guide wires are not intended for cerebral vasculature. Medtronic steerable exchange guide wires are used to facilitate the substitution of one diagnostic or interventional device for another.","G13A00117 G13A00735 G13A00792 G13A00794 G13A01324 GV259 GV261 GV276 GV287 GV847 GV848 GV849 GV851 GV852 GW690 GW758 ",,"58","Potential for PTFE (polytetrafluroethylene) coating to delaminate and detach from Guidewire. ",10/21/2013,"10/21/2013",11/27/2013,"11/27/2013"
"Devices",66567,"Ongoing","Medtronic Vascular","Danvers","MA","US","Voluntary: Firm Initiated","Letter","Worldwide distribution: US (Nationwide) including states of: AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, IA, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, WA, WI, and WV; and countries of: Albania, Argentina, Australia, Austria, Belgium, Brazil, Canada, Chile, China, Colombia, Croatia, Czech Republic, Denmark, Ecuador, Egypt, Finland, France, Georgia, Germany, Greece, Guyana, Honduras, Hong Kong,Hungary, Iceland, India, Ireland, Israel, Italy, Japan, Jordan, Kuwait, Lebanon, Libya, Luxembourg, Malaysia, Mexico, Montenegro, Nepal, Netherlands, New Zealand, Nepal, Nicaragua, Norway, Oman, Poland, Portugal Puerto Rico, Qatar, Russian Federation, Saudi Arabia, Serbia, Singapore, Slovakia, South Africa, Spain, Sweden, Switzerland, Taiwan, Thailand, Tunisia, United Kingdom, Uruguay, and Yemen.","Z-0261-2014","Class I","Cougar Nitinol Workhorse Guidewire: Models: CGRLS190HJ, CGRLS190HS, CGRLS190S, CGRLS300HS, CGRLS300S. CGRXT190HJ, CGRXT190HS, CGRXT190J, CGRXT190S, CGRXT300HJ, CGRXT300HS, CGRXT300J, CGRXT300S Medtronic guide wires are steerable guide wires that are used for the introduction and placement of diagnostics or interventional devices in the coronary and peripheral vasculature, and may be used to reach and cross a target lesion. Medtronic guide wires are not intended for cerebral vasculature. Medtronic steerable exchange guide wires are used to facilitate the substitution of one diagnostic or interventional device for another.","G13A00104 G13A00105 G13A00106 G13A00107 G13A00108 G13A00109 G13A00110 G13A00112 G13A00113 G13A00114 G13A00692 G13A00713 G13A00734 G13A00788 G13A00803 G13A00804 G13A00809 G13A00810 G13A00811 G13A00874 G13A00971 G13A00972 G13A00973 G13A00974 G13A00975 G13A00976 G13A00977 G13A00978 G13A00979 G13A00980 G13A00981 G13A00982 G13A01016 G13A01017 G13A01330 G13A01400 G13A01401 G13A01409 G13A01410 G13A01411 G13A01446 G13A01449 G13A01452 G13A01569 G13A01584 G13A01600 G13A01604 G13A01605 G13A01606 G13A01607 G13A01608 G13A01609 GV827 GV829 GV830 GV831 GV832 GV835 GV836 GV837 GV838 GV839 GV840 GV844 GV845 GW405 GW406 GW407 GW508 GW509 GW510 GW675 GW687 GW688 GW706 GW710 GW745 GW746 ",,"10,230","Potential for PTFE (polytetrafluroethylene) coating to delaminate and detach from Guidewire. ",10/21/2013,"10/21/2013",11/27/2013,"11/27/2013"
"Devices",66567,"Ongoing","Medtronic Vascular","Danvers","MA","US","Voluntary: Firm Initiated","Letter","Worldwide distribution: US (Nationwide) including states of: AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, IA, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, WA, WI, and WV; and countries of: Albania, Argentina, Australia, Austria, Belgium, Brazil, Canada, Chile, China, Colombia, Croatia, Czech Republic, Denmark, Ecuador, Egypt, Finland, France, Georgia, Germany, Greece, Guyana, Honduras, Hong Kong,Hungary, Iceland, India, Ireland, Israel, Italy, Japan, Jordan, Kuwait, Lebanon, Libya, Luxembourg, Malaysia, Mexico, Montenegro, Nepal, Netherlands, New Zealand, Nepal, Nicaragua, Norway, Oman, Poland, Portugal Puerto Rico, Qatar, Russian Federation, Saudi Arabia, Serbia, Singapore, Slovakia, South Africa, Spain, Sweden, Switzerland, Taiwan, Thailand, Tunisia, United Kingdom, Uruguay, and Yemen.","Z-0266-2014","Class I","COUGAR Steerable Guidewire; Models: LVCLS190J, LVCLS190S, LVCXT190J, LVCXT190S Medtronic guide wires are steerable guide wires that are used for the introduction and placement of diagnostics or interventional devices in the coronary and peripheral vasculature, and may be used to reach and cross a target lesion. Medtronic guide wires are not intended for cerebral vasculature. Medtronic steerable exchange guide wires are used to facilitate the substitution of one diagnostic or interventional device for another","G13A00805 G13A00814 G13A00815 G13A01447 G13A01450 GW547 ",,"20","Potential for PTFE (polytetrafluroethylene) coating to delaminate and detach from Guidewire. ",10/21/2013,"10/21/2013",11/27/2013,"11/27/2013"
"Devices",66569,"Ongoing","Southern Implants, Inc","Irvine","CA","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution - USA (nationwide) and Internationally to Canada, Guatemala, Taiwan.","Z-0382-2014","Class II","Tri-Nex Healing Abutment, 0.50 mm x 5 mm height, Catalog No. HA-L-50-5. The NSI Implant System is intended to be implanted in the upper and lower jaw arches to provide support for fixed or removable dental prostheses in a single tooth, partially edentulous prostheses, or full arch prostheses. It further adds the option for immediate loading on single and splinted multiple unit restorations when good primary stability is achieved and with appropriate occlusal loading, to restore chewing function.","Lot # 2676021303",".","197 units","Southern Implants is recalling the Tri-Nex healing abutment because the package was incorrectly labeled and packaged as the Tri-Nex healing abutment, 05.0 mm x 5 mm height (HA-L-50-5). The package contains the Tri-Nex healing abutment 05.0 mm x 6.0 mm Flare x 5 mm Height (HA-L-50W-5).",9/13/2013,"09/13/2013",12/4/2013,"12/04/2013"
"Devices",66570,"Ongoing","Intuitive Surgical, Inc.","Sunnyvale","CA","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution - USA (nationwide) and Internationally tAustralia, Austria, Belgium, Brazil, *Bulgaria, Canada, Chile, China, Czech Republic, Denmark, Finland, France, Germany, Great Britain, India, Israel, Italy, Mexico, Monaco, Netherlands, Norway, Pakistan, Panama, Qatar, Romania, Russian Fed., Saudi Arabia, Singapore, South Korea, Sweden, Switzerland, Taiwan, and Turkey.","Z-0146-2014","Class III","da Vinci Vision System Cart, a component of the da Vinci Si Surgical System IS3000; Y1903 Illuminator (Illuminator + Lamp Module); Y1902 Replacement Lamp Modules. Intuitive Surgical, Sunnyvale, CA. As a component of the IS3000 da Vinci Si Surgical System, the 3DHD Vision System provides a high resolution image for the surgeon (at the 3D viewer) and the patient-side assistant (at the touchscreen). The 3DHD endoscope assembly (endoscope and camera head) can be used manually (that is, handheld, as with a traditional endoscopy cart) or can be mounted on the camera arm to assist with preoperative exploration. Also integrated in the Vision System Cart is the Illuminator. The illuminator has a single light source attached to the endoscopy assembly by the light guide cable. It provides illumination inside the body for vision of the surgical field. The Illuminator monitors the life left on the lamp module and notifies the customer when replacement is recommended. ","Model # 380990 Y1903 (PN951183-05) Illuminators shipped with lamp module with coated housing. Serial numbers: 11K1903D7944 11K1903D7949 11K1903D7950 11K1903D7951 11K1903D7952 11K1903D7953 11K1903D7954 11L1903D7989 11L1903D7990 11L1903D7991 11L1903D7992 11L1903D7993 11L1903D7994 11L1903D7995 11L1903D7996 11L1903D7997 11L1903D7998 11L1903D7999 11L1903D8000 11L1903D8001 11L1903D8002 11L1903D8003 11L1903D8004 11L1903D8005 11L1903D8006 11L1903D8007 11L1903D8008 11L1903D8009 11L1903D8010 11L1903D8011 11L1903D8012 11L1903D8013 11L1903D8014 11L1903D8015 11L1903D8016 11L1903D8017 11L1903D8018 11L1903D8019 11L1903D8020 11L1903D8021 11L1903D8022 11L1903D8023 11L1903D8024 11L1903D8025 11L1903D8026 11L1903D8027 11L1903D8028 11L1903D8029 11L1903D8030 11L1903D8031 11L1903D8032 11L1903D8033 11L1903D8034 11L1903D8035 11L1903D8036 11L1903D8037 11L1903D8038 11L1903D8039 11L1903D8040 11L1903D8041 11L1903D8042 11L1903D8043 11L1903D8044 11L1903D8045 11L1903D8046 11L1903D8047 11L1903D8048 11L1903D8049 11L1903D8050 11L1903D8051 11L1903D8052 11M1903D8078 11M1903D8079 11M1903D8080 11M1903D8081 11M1903D8082 11M1903D8083 11M1903D8084 11M1903D8085 11M1903D8086 11M1903D8087 11M1903D8088 11M1903D8089 11M1903D8090 11M1903D8091 11M1903D8092 11M1903D8093 11M1903D8094 11M1903D8095 11M1903D8096 11M1903D8097 11M1903D8098 11M1903D8099 11M1903D8100 11M1903D8101 11M1903D8102 11M1903D8103 11M1903D8104 11M1903D8105 11M1903D8106 11M1903D8107 11M1903D8108 11M1903D8109 11M1903D8127 11M1903D8128 11M1903D8129 11M1903D8130 11M1903D8131 11M1903D8132 11M1903D8133 11M1903D8134 11M1903D8135 11M1903D8136 11M1903D8137 11M1903D8138 11M1903D8139 11M1903D8140 11M1903D8141 11M1903D8142 11M1903D8143 11M1903D8144 11M1903D8145 11M1903D8146 11M1903D8147 11M1903D8148 11M1903D8149 11M1903D8150 11M1903D8151 11M1903D8152 11M1903D8153 11M1903D8154 11M1903D8155 11M1903D8156 11M1903D8157 11M1903D8158 12A1903D8292 12A1903D8293 12A1903D8294 12A1903D8295 12A1903D8296 12A1903D8297 12A1903D8298 12A1903D8299 12A1903D8300 12A1903D8301 12A1903D8302 12A1903D8303 12A1903D8304 12A1903D830",".","Standalone: 161 units; With Vision Starter Kit: 240 units; With IS3000 Vision Cart: 283 units","Intuitive has identified that the metalized coating on the IS3000 HD lamp module may be incompatible with the illuminator control board, leading to an erroneous red Preventive Maintenance Message that shows up on monitors.",10/21/2013,"10/21/2013",11/13/2013,"11/13/2013"
"Biologics",66571,"Terminated","Blood Center of Northcentral Wisconsin, Inc.","Wausau","WI","US","Voluntary: Firm Initiated","Letter","WI","B-0117-14","Class III","Red Blood Cells Leukocytes Reduced","W229813503504; W229813503514; W229813503517; W229813503533; W229813503634; W229813503920",".","6 units","Blood products, labeled with incorrect or missing information, were distributed.",10/1/2013,"10/01/2013",12/26/2013,"12/26/2013"
"Biologics",66572,"Terminated","Blood Systems, Inc","Albuquerque","NM","US","Voluntary: Firm Initiated","Telephone","NM","B-0118-14","Class III","Red Blood Cells Leukocytes Reduced","W041213047147I",".","1 unit","Blood product, labeled with incorrect or missing information, was distributed. ",8/27/2013,"08/27/2013",12/26/2013,"12/26/2013"
"Biologics",66573,"Terminated","Upstate New York Transplant Services","Buffalo","NY","US","Voluntary: Firm Initiated","Telephone","NY","B-0119-14","Class II","Red Blood Cells (Apheresis) Leukocytes Reduced","W280313601571",".","1 unit","Blood product, collected from a donor who had traveled to a malarial endemic area, was distributed.",9/3/2013,"09/03/2013",12/26/2013,"12/26/2013"
"Devices",66574,"Ongoing","St. Jude Medical","Plymouth","MN","US","Voluntary: Firm Initiated","Letter","Nationwide Distribution including the states of KY, OH, TX, MA, and NC.","Z-0187-2014","Class II","Safire Duo Ablation Catheter MediGuide Enabled, REF A700240 and A700238, Rx only, Sterile EO. Intended for creating endocardial lesions during cardiac ablation procedures (mapping, stimulation and ablation) for the treatment of typical atrial flutter.","Catalog Number A700238, Batch Number 4113243, 4152911. Catalog Number A700240, Batch Number 4113242, 4124985.",".","46","St. Jude Medical Cardiovascular and Ablation Technologies Division is performing a voluntary notification regarding selected batched of Safire Duo Ablation Catheter MediGuide Enabled. These units have a cable connector configuration that is different than intended. ",10/11/2013,"10/11/2013",11/20/2013,"11/20/2013"
"Food",66575,"Ongoing","Boston Salads & Provisions Co., Inc.","Boston","MA","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","CT, MA, ME,RI,VT,","F-0411-2014","Class I"," Shrimp Salad packaged in: 5 lb Packaged under the following labels: Boston Salads, Rachaels Gourmet, Dietz and Watson, and Fresh Ideas ","Sell By dates between 9/13/2013 and 11/1/2013 ",".","106 cases","Product maybe contaminated with Listeria monocytogenes",10/24/2013,"10/24/2013",12/11/2013,"12/11/2013"
"Food",66575,"Ongoing","Boston Salads & Provisions Co., Inc.","Boston","MA","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","CT, MA, ME,RI,VT,","F-0408-2014","Class I","Tuna Salads- packaged in: 7 oz., 12 oz., 5 lb.10 lb and 30 lb containers Sold under the labels: Boston Salads and the Rachel's Gourmet and Dietz and Watson ","Sell By dates between 9/13/2013 and 11/13/2013",".","8068","Product maybe contaminated with Listeria monocytogenes",10/24/2013,"10/24/2013",12/11/2013,"12/11/2013"
"Food",66575,"Ongoing","Boston Salads & Provisions Co., Inc.","Boston","MA","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","CT, MA, ME,RI,VT,","F-0413-2014","Class I","Chef Recipe Potato Salad/Potato and Egg packaged in 7 oz., 15 oz., 5 lbs,10 lbs, 30 lbs Sold under the label: Boston Salads, Rachaels Gourmet, Dietz and Watson ","Sell By dates between 9/13/2013 and 11/4/2013 ",".","2336","Product maybe contaminated with Listeria monocytogenes",10/24/2013,"10/24/2013",12/11/2013,"12/11/2013"
"Food",66575,"Ongoing","Boston Salads & Provisions Co., Inc.","Boston","MA","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","CT, MA, ME,RI,VT,","F-0412-2014","Class I","Seafood and Shrimp Salad packaged in 5 lb Sold under the label: Boston Salads","Sell By dates between 9/13/2013 and 11/4/2013 ",".","259","Product maybe contaminated with Listeria monocytogenes",10/24/2013,"10/24/2013",12/11/2013,"12/11/2013"
"Food",66575,"Ongoing","Boston Salads & Provisions Co., Inc.","Boston","MA","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","CT, MA, ME,RI,VT,","F-0409-2014","Class I","Garden Tuna Salads- 5lbs sold under the label: Costa Fruit Fresh Ideas ","Sell By dates between 9/16/2013 and 11/4/2013",".","894 cases","Product maybe contaminated with Listeria monocytogenes",10/24/2013,"10/24/2013",12/11/2013,"12/11/2013"
"Food",66575,"Ongoing","Boston Salads & Provisions Co., Inc.","Boston","MA","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","CT, MA, ME,RI,VT,","F-0410-2014","Class I","Seafood Salad packaged in: 7 oz., 12 oz., 30 lbs. Packaged under the following labels: Boston Salads, Rachaels Gourmet, Dietz and Watson, and Fresh Ideas ","Sell By dates between 9/13/2013 and 11/4/2013 ",".","3363","Product maybe contaminated with Listeria monocytogenes",10/24/2013,"10/24/2013",12/11/2013,"12/11/2013"
"Food",66576,"Ongoing","Cgnp Manufacturing","Valencia","CA","US","Voluntary: Firm Initiated","E-Mail","California.","F-0166-2014","Class II","Beachbody Optimize Enzymes Capusles, 126 CT, 8 oz. Container size: JAR 8OZ WHITE 70MM NECK POLYPROPYLENE 126 capsules per bottle. Product labeling reads in part:'' BEACHBODY ULTIMATE OPTIMIZE Promotes healthy metabolism and effective body funtions***DIETARY SUPPLEMENT 126 Capsules***BEACHBODY, LLC Santa Monica, CA***''.","Item# 5109-126 LOT#17952-1",".","500 bottles","CGNP initiated this recall because the raw material Exclezyme received from Specialty Enzymes used by CGNP in the formulation of Beachbody Optimize Enzymes Capsules CG has been found to contain chloramphenicol. ",10/7/2013,"10/07/2013",11/20/2013,"11/20/2013"
"Food",66576,"Ongoing","Cgnp Manufacturing","Valencia","CA","US","Voluntary: Firm Initiated","E-Mail","California.","F-0167-2014","Class II"," Beach Body Ultimate Reset Kit 2.0( each Kit consist of 1 bottle of the above optimize enzymes capsules product and 5 bottles of additional product) Product labeling reads in part:'' BEACHBODY ULTIMATE RESET KIT 2.0*** BEACHBODY, LLC Santa Monica, CA***''.","Item# 5109-126 LOT#17952-1",".","6,152 kits","CGNP initiated this recall because the raw material Exclezyme received from Specialty Enzymes used by CGNP in the formulation of Beachbody Optimize Enzymes Capsules CG has been found to contain chloramphenicol. ",10/7/2013,"10/07/2013",11/20/2013,"11/20/2013"
"Devices",66577,"Ongoing","Synthes USA HQ, Inc.","West Chester","PA","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution - USA (nationwide) and Internationally to Canada .","Z-0405-2014","Class II","Synthes Implant Holder for Synfix (TM)-LR the Synthes Implant Holder for Synfix (TM)-LR is a non-powered hand-held device intended for medical purposes to manipulate tissue, or for use with other devices in orthopedic surgery","all lots of part no. 03.802.039",".","548","Complaints were received which described the SynFix LR implant holder breaking at the interface between the implant and the holder. ",10/8/2013,"10/08/2013",12/4/2013,"12/04/2013"
"Food",66578,"Ongoing","Oma's Choice Inc","Columbus","TX","US","Voluntary: Firm Initiated","Telephone","The firm distributes these products in Texas.","F-0726-2014","Class II","Oma's Choice, Pickled Quail Eggs, Net. Wt. 16 oz., Made Espcially For Oma's Choice, 4042 F.M. 3171 Schulenburg, TX 78956.","UPC 8 17071 00999 9,Lots: 13184, 13190, 13198, 13204, 13212, 13218, 13227, 13242, 13249, 13256,13263, 13270, 13276, 13283, 13288",".","480 cases (12 jars per case)","The firm had not submitted their products to a process authority for evaluation. ",10/22/2013,"10/22/2013",12/11/2013,"12/11/2013"
"Food",66578,"Ongoing","Oma's Choice Inc","Columbus","TX","US","Voluntary: Firm Initiated","Telephone","The firm distributes these products in Texas.","F-0724-2014","Class II","Oma's Choice, Baby Dill Pickles, Net Wt. 16.oz., Made Espcially For Oma's Choice, 4042 F.M. 3171 Schulenburg, TX 78956.","UPC 6 88290 20146 0 Lots:13184, 13198, 13204, 13212, 13263, 13270, 13276,13290",".","74","The firm had not submitted their products to a process authority for evaluation. ",10/22/2013,"10/22/2013",12/11/2013,"12/11/2013"
"Food",66578,"Ongoing","Oma's Choice Inc","Columbus","TX","US","Voluntary: Firm Initiated","Telephone","The firm distributes these products in Texas.","F-0727-2014","Class II","Oma's Choice, Habanero Garlic, Net Wt. 16 oz., Made Espcially For Oma's Choice, 4042 F.M. 3171 Schulenburg, TX 78956.","UPC: 8 17071 00136 8 Lots: 13256, 13263, 13277, 13283, 13290",".","28","The firm had not submitted their products to a process authority for evaluation. ",10/22/2013,"10/22/2013",12/11/2013,"12/11/2013"
"Food",66578,"Ongoing","Oma's Choice Inc","Columbus","TX","US","Voluntary: Firm Initiated","Telephone","The firm distributes these products in Texas.","F-0728-2014","Class II","Oma's Choice, Habanero Chunk Pickles, Net Wt 32 oz., Made Espcially For Oma's Choice, 4042 F.M. 3171 Schulenburg, TX 78956.","UPC 8 17071 00102 3, Lots: 13184, 13204, 13212, 13220, 13227, 13235, 13242, 13256, 13263, 13270, 13276, 13283, 13289",".","127 cases (12 jars per case)","The firm had not submitted their products to a process authority for evaluation. ",10/22/2013,"10/22/2013",12/11/2013,"12/11/2013"
"Food",66578,"Ongoing","Oma's Choice Inc","Columbus","TX","US","Voluntary: Firm Initiated","Telephone","The firm distributes these products in Texas.","F-0725-2014","Class II","Oma's Choice, Dilled Garlic, Net. Wt. 16 oz, Made Espcially For Oma's Choice, 4042 F.M. 3171 Schulenburg, TX 78956.","UPC 8 17071 00132 0 Lots: 13256, 13263, 13277, 13283, 13290",".","28","The firm had not submitted their products to a process authority for evaluation. ",10/22/2013,"10/22/2013",12/11/2013,"12/11/2013"
"Food",66579,"Ongoing","Kashmir Crown Baking LLC","Linden","NJ","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","CA, Canada","F-0121-2014","Class I","KCB Pista Khatie KCB Bakery Products Corp. 56-28 56th Street, Maspeth, NY 11378 Tel: (718) 786-9463 Fax (718) 361-0171 www.kbcusa.com a) Net Wt. 30 OZ (850 G) b) Net Wt. 13 OZ (369 G) Packaged in a plastic clam shell container with stick-on labels.","Use By Date: 16 May 14; 13 oz. package UPC Code: 12042 00129; 30 oz. package UPC Code: 12042 00296",".","24 cases x 12 plastic clam shell boxes; 15 cases x 13 clam shel boxes","The firm's Pista Khatie cookies with use by date 16 May 14 were tested by the Canadian Food Inspection Agency (CFIA) and found to contain 70 ppm of undeclared egg allergen. The label for this product states that it does not contain eggs.",10/17/2013,"10/17/2013",11/13/2013,"11/13/2013"
"Devices",66580,"Ongoing","Synthes USA HQ, Inc.","West Chester","PA","US","Voluntary: Firm Initiated","Letter","Nationwide Distribution","Z-0394-2014","Class II","Synthes Spiked Washers 13.5/6.5 Spiked Washers 13.5/6.5 are intended to be used in ligament reattachment or fixation, specifically readaptation of torn or avulsed ligaments.","part 219.951 with multiple lot#: 2335941 2339634 2397429 2405812 2440475 2442736 2496414 5661855 5663841 ",".","3087","During a retrospective assessment, Spiked Washers 13.5/6.5 were discovered to be mislabeled as Spiked Washers 13.5/5.5. ",10/3/2013,"10/03/2013",12/4/2013,"12/04/2013"
"Devices",66581,"Ongoing","Synthes USA HQ, Inc.","West Chester","PA","US","Voluntary: Firm Initiated","Letter","Nationwide Distribution","Z-0404-2014","Class II","Synthes 14.5 mm Outer Protection Sleeve for Suprapatellar Synthes 14.5 mm Outer Protection Sleeve for Suprapatellar is used as part of the Synthes Tibial Nail System EX to stabilize fractures of the proximal and distal tibia and the tibia shaft, open and closed tibia shaft fractures, certain pre- and post- isthmic fractures, and tibial malunions and non-unions. ","part no. 03010.438S, lot 706802",".","55","Complaints were received reporting that a product packaged as a 14.5 mm Outer Protection Sleeve for Suprapatellar contained a 12.0 mm Outer Protection Sleeve for Suprapatellar. ",10/14/2013,"10/14/2013",12/4/2013,"12/04/2013"
"Devices",66582,"Ongoing","Synthes USA HQ, Inc.","West Chester","PA","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution - USA (nationwide) Canada and Mexico","Z-0473-2014","Class II","Synthes TomoFix Plates The Synthes J5606-C TomoFix Osteotomy System is used for open and closed wedge osteotomies of the medial proximal tibia, lateral proximal tibia, medial and lateral distal femur, treatment of bone and joint deformities, fractures, and malalignment caused by injury or disease such as osteoarthritis.","J5606-C",,"2912","A labeling correction was initiated related to the Surgical Technique Guide J5606-C ''TomoFix Osteotomy System'' due to the potential for a surgical delay if the surgeon inserts the superior screws at a lesser angle (4 or 6 degrees) and is not aware that those angles are not present. ",10/9/2013,"10/09/2013",12/18/2013,"12/18/2013"
"Biologics",66583,"Terminated","International Biologics LLC","Scottsdale","AZ","US","Voluntary: Firm Initiated","Telephone","California","B-0102-14","Class II","Tendon","IBM1346174008; ",,"1 allograft","Human tissue allograft, not processed in a manner that prevents the introduction, transmission, or spread of communicable disease, was distributed.",9/23/2013,"09/23/2013",12/18/2013,"12/18/2013"
"Biologics",66584,"Terminated","Eye Bank For Sight Restoration","New York","NY","US","Voluntary: Firm Initiated","Telephone","New York","B-0101-14","Class II","Cornea","095113; ",,"1 allograft","Human allograft, recovered from a donor who may have participated in high risk behavior, was distributed. ",10/10/2013,"10/10/2013",12/18/2013,"12/18/2013"
"Devices",66586,"Ongoing","Arrow International Inc","Reading","PA","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution - USA (Nationwide) and Internationally to Australia, Brazil, Canada, China, Ireland, New Zealand, Singapore, and Thailand.","Z-0468-2014","Class II","Arrow Transradial Artery Access products Arrow Transradial Artery Access products are used for percutaneous introduction of devices into the radial artery for diagnostic and therapeutic purposes. ","Multiple: Expressed as Catalog # (AA#) lot number (RF#), and expiration date (year-month) : AA-15611-S RF0018142 2015-01 AA-15611-S RF1069509 2016-06 AA-15511-S RF0021262 2015-02 AA-15611-S RF1069978 2016-06 AA-15611-S RF0021263 2015-03 AA-15611-S RF1070556 2016-07 AA-15511-S RF0022395 2015-03, AA-15611-S RF1070730 2016-07, AA-15611-S RF0022652 2015-03, AA-15511-S RF1070880 2016-07, AA-15511-S RF0033719 2015-03, AA-15611-S RF1071062 2016-07, AA-15511-S RF0046459 2015-04, AA-15611-S RF1071206 2016-08, AA-15611-S RF0046461 2015-04, AA-15511-S RF1071354 2016-07, AA-15611-S RF0048269 2015-05, AA-15611-S RF1071757 2016-08, AA-15511-S RF0059652 2015-06, AA-15511-S RF1071798 2016-08, AA-15511-S RF0062416 2015-06, AA-15611-S RF1082042 2016-08, AA-15611-S RF0062419 2015-06, AA-15611-S RF1082374 2016-08, AA-15611-S RF0087575 2015-08, AA-15611-S RF1082709 2016-08, AA-15511-S RF0087577 2015-08, AA-15611-S RF1082956 2016-08, AA-15611-S RF0087845 2015-08, AA-15511-S RF1082959 2016-08, AA-15511-S RF0088503 2015-08, AA-15511-S RF1083632 2016-09, AA-15611-S RF0089041 2015-08, AA-10407-1 RF1093923 2013-09, AA-15511-S RF0091088 2015-09, AA-10507-1 RF1093924 2013-09, AA-15611-S RF0092014 2015-09, AA-10511-1 RF1093925 2013-09, AA-15511-S RF0092144 2015-09, AA-15511-S RF1093936 2016-09, AA-15511-S RF0104465 2015-10, AA-15611-S RF1093937 2016-09, AA-15611-S RF0104466 2015-10, AA-15611-S RF1094515 2016-10, AA-15611-S RF0115587 2015-11, AA-15511-S RF1094910 2016-10, AA-15511-S RF0115903 2015-11, AA-15611-S RF1105690 2016-10, AA-15611-S RF0117454 2015-12, AA-15611-S RF1105980 2016-10, AA-15511-S RF0117682 2015-12, AA-15511-S RF1105983 2016-10, AA-15611-S RF0129193 2016-01, AA-15511-S RF1106517 2016-11, AA-15611-S RF1010343 2016-01, AA-15611-S RF1117682 2016-11, AA-15611-S RF1011171 2016-01, AA-15611-S RF1128383 2016-12, AA-15511-S RF1011172 2016-01, AA-15511-S RF2010359 2017-01, AA-15511-S RF1019756 2016-01, AA-15611-S RF2010467 2017-02, AA-15511-S RF1022056 2016-02, AA-15511-S RF2010675 2017-02, AA-15611-S RF1023132 2016-03, AA-15611-",,"294430","There is a risk that the introducer needles packaged within the kits can be partially or fully occluded, which can cause delayed treatment or an adverse event when used on a patient.",10/9/2013,"10/09/2013",12/18/2013,"12/18/2013"
"Devices",66587,"Ongoing","Trumpf Medical Systems","Charleston","SC","US","Voluntary: Firm Initiated","Telephone","US Distribution: NJ only","Z-0155-2014","Class III","ORBIT PT. The ORBIT PT works in conjunction with an TRUMPF mobile operating table to automate the patient transport process.","Item No. 1275499, Serial No. 100711351",".","One","An odor and smoke developed - The cause was determined to be a power supply unit sitting in the controller column.",7/24/2013,"07/24/2013",11/13/2013,"11/13/2013"
"Food",66588,"Ongoing","Quaker Foods and Snacks North America","Chicago","IL","US","Voluntary: Firm Initiated","Letter","US: Nationwide (AL, FL, GA, IL, IN, KS, KY, MI, MO, MS, NC, OH, SC, TN, WI)","F-0172-2014","Class II","White grits packaged in a paper bag labeled in part: Smooth & Creamy; Aunt Jemima; Quick GRITS; Cooks in about 5 minutes; ENRICHED WHITE HOMINY; NET WT 36.8 oz. (2 lb. 4.8 oz.) 1043g","Aunt Jemima Quick Grits Enriched White Hominy: UPC:30000 04260, 300000 42601; Best Before Date: February 26, 2014 ",".","2,720 cases (32,640 bags)","Some Aunt Jemima brand Buttermilk Self-Rising Corn Meal Mix, Quick Grits Enriched with White Hominy, and Buttermilk Self-Rising Corn Meal Mix White have levels of aflatoxin above the legal limit..",10/8/2013,"10/08/2013",11/20/2013,"11/20/2013"
"Food",66588,"Ongoing","Quaker Foods and Snacks North America","Chicago","IL","US","Voluntary: Firm Initiated","Letter","US: Nationwide (AL, FL, GA, IL, IN, KS, KY, MI, MO, MS, NC, OH, SC, TN, WI)","F-0171-2014","Class II","*** 1) Corn meal mix packaged in a paper bag labeled in part: Aunt Jemima; Buttermilk; Self-Rising White; Corn Meal Mix; Flour, Salt & Baking Powder Already Blended In; NET WT 32 OZ (2 LB); *** 2) Corn meal mix packaged in a paper bag labeled in part: Aunt Jemima; Buttermilk; Self-Rising White; Corn Meal Mix; Flour, Salt & Baking Powder Already Blended In; NET WT 5 LB","*** 1) Aunt Jemima; Buttermilk Self-Rising White Corn Meal Mix NET WT 32 OZ (2 LB); UPC: 30000 05468, 300000 54604; Best Before Date: March 4, 2014; Cases of 12 bags labeled with UPC: 10030000054502; *** 2) Aunt Jemima; Buttermilk Self-Rising White Corn Meal Mix NET WT 5 LB; UPC: 30000 05450, 300000 54505; Best Before Date: February 3, 2014; Cases of 8 bags labeled with UPC: 00300000546004",".","*** 1) 5,342 cases (64,104 bags); *** 2) 5,369 cases (42,656 bags)","Some Aunt Jemima brand Buttermilk Self-Rising Corn Meal Mix, Quick Grits Enriched with White Hominy, and Buttermilk Self-Rising Corn Meal Mix White have levels of aflatoxin above the legal limit..",10/8/2013,"10/08/2013",11/20/2013,"11/20/2013"
"Devices",66589,"Ongoing","Arrow International Inc","Reading","PA","US","Voluntary: Firm Initiated","Letter","Worldwide distribution: US (nationwide) including states of: MA, LA, CA, GA, KS, TX, PA, NY, MO, WI, NJ, MS, CT, ID, AL, CO, and PR; and Singapore.","Z-0546-2014","Class II","Continuous Peripheral Nerve Block Catheter Kit and Set Continuous Peripheral Nerve Block Catheter Kit and Set permits placement of catheters next to nerves and nerve plexuses for continuous nerve block anesthesia or analgesia techniques for periods not exceeding 72 hours.","Product number AB-07200 Stimulator Adapter Cable with lot numbers: RF0059570, RF2069779, RF0088984, RF2108983, RF0128588, RF3052266, RF1071764.",".","121","A labeling inconsistency was discovered in which the lidstock states that the kit contains a stimulator cable with 1.5mm socket, however, the kit contains a stimulator cable with 1.5mm pin. ",10/9/2013,"10/09/2013",12/26/2013,"12/26/2013"
"Devices",66596,"Ongoing","Omnyx Llc","Pittsburgh","PA","US","Voluntary: Firm Initiated","Letter","International Distribution to Canada and Switzerland only.","Z-0469-2014","Class II","Digital Pathology System (DPS) Software version 1.1 The Omnyx'' Integrated Digital Pathology system, which consists of a whole slide scanner and associated software applications, is a scanning, receiving, storing, managing, annotating and computer monitor viewing system for digital whole slide images. Omnyx'' products are for in vitro diagnostic use for specific clinical applications, and are intended for research use only on other applications. Specific clinical use applications are indicated in separate clinical specific user guides supplied by Omnyx.","catalog # OMN-1005056-1, K1600LH, DPS 1.1",,"2 ","There is an issue associated with Digital Pathology System (DPS) Software, in which the annotation tools within the DPS version 1.1 Image Viewer will display incorrect measurements and area calculations for a region of interest on a scanned slide, under certain conditions. ",10/1/2013,"10/01/2013",12/18/2013,"12/18/2013"
"Devices",66597,"Ongoing","St. Jude Medical","Plymouth","MN","US","Voluntary: Firm Initiated","Letter","US distribution: KS, MA, UT,TX, KY, OH.","Z-0174-2014","Class II"," US Safire Duo Ablation Catheter MediGuide Enabled, REF A700240 and Cool Path Duo Ablation Catheter, MediGuide Enabled REF A700244, Rx only, Sterile EO. The catheters are intended for use with a compatible external irrigation pump and the IBI-15500T9-CP RF Generator at a maximum of 50 Watts. MediGuide Enabled Ablation catheters are used with the MediGuide Technology to enable real-time tip positioning and navigation and in conjunction the the EnSite Velocity System. The MediGuide Technology is indicated for use as an adjunct to fluoroscopy.","Catalog Number A700244 Batch Number 4113241. Catalog Number A700240 Batch Number 4113242.",".","59","St. Jude Medical Cardiovascular and Ablation Technologies Division is performing a voluntary notification regarding selected batches of Coolpath Duo Ablation Catheter MediGuide Enabled products and Safire Duo Ablation Catheter MediGuide Enabled. These units were inadvertently shipped with the incorrect version of the Instructions for Use (IFU). ",10/11/2013,"10/11/2013",11/13/2013,"11/13/2013"
"Devices",66598,"Ongoing","Urologix, Inc.","Minneapolis","MN","US","Voluntary: Firm Initiated","Letter","Nationwide Distribution-including the states of AZ, CA, FL, GA, IL, KY, MA, MN, NC, NJ, NV, NY, OH, OR, TN, TX, and UT.","Z-0182-2014","Class II","Prostiva RF Therapy Hand Piece Kit, REF 8929, Rx only, sterilized using Ethylene Oxide. The Prostiva RF Model 8929 Hand Piece Kit is the delivery system component of the Prostiva RF Therapy System. Prostiva RF Therapy delivers low-levels of radiofrequency (RF) energy directly into the hyperplastic tissue for the treatment of benign prostatic hyperplasia (BPH). The RF energy delivered by the system provides selective thermal ablation of prostate tissue to help reduce urethral constriction and relieve BPH voiding symptoms. The Prostiva RF Therapy System consists of the following major components: '' Radio Frequency Generator '' Hand Piece Kit '' Telescope The Model 8929 Prostiva RF Therapy Hand Piece Kit contains the following single-use, disposable components: '' One sterile Hand Piece with radio frequency cable (Model 8929) '' One sterile Tubing System (Model 6101) '' One non-sterile Return Electrode (Model 8934) The hand piece has two insulated electrode needles that deliver the radio frequency energy interstitially to the prostate. These needles are covered by insulating shields that localize the lesions within the prostate, protect the urethra from thermal damage, and eliminate collateral thermal damage. The Hand Piece stainless steel (SS) tube is inserted into the urethral canal up to the prostate with the aid of a telescope for visualization during the therapy. The Hand Piece features two insulated Nitinol needles inside the SS tube. The needles can be deployed (extended), at approximately a 90-degree angle from the SS tube, to a preset depth of between 12 mm and 22 mm (at 2 mm intervals). The needles inside the SS tube are deployed into, or retracted from the prostate, using the handle lever. RF energy is delivered through the needles to the prostate tissue. The RF energy creates molecular friction eventually resulting in tissue heating and cell death (therapy intent). ","Kit Lot Number: 215251, Hand Piece Lot Number: 13E005M.",".","142","Urologix is voluntarily recalling Prostiva RF Therapy Hand Piece Kits, Part Number 8929, Lot Number 215251 due to a Hand Piece not meeting an in-process force test specification.",10/21/2013,"10/21/2013",11/20/2013,"11/20/2013"
"Biologics",66599,"Terminated","Arc Blood Services, New England Region","Dedham","MA","US","Voluntary: Firm Initiated","Telephone","NY, MA","B-0059-14","Class II","Platelets Pheresis Leukocytes Reduced","W200413808670-P1; W200413808670-P2; W200413808697",".","3 units","Blood products, which did not meet the acceptable product specifications for release, were distributed.",8/13/2013,"08/13/2013",12/26/2013,"12/26/2013"
"Biologics",66599,"Terminated","Arc Blood Services, New England Region","Dedham","MA","US","Voluntary: Firm Initiated","Telephone","NY, MA","B-0058-14","Class II","Platelets Pheresis Leukocytes Reduced Irradiated","W200413808675-P3; W200413808675-P2; W200413808675-P1",".","3 units","Blood products, which did not meet the acceptable product specifications for release, were distributed.",8/13/2013,"08/13/2013",12/26/2013,"12/26/2013"
"Devices",66600,"Ongoing","RAYSEARCH LABORATORIES AB","Stockholm",,"SE","Voluntary: Firm Initiated","E-Mail","US Distribution in the states of: California, Colorado, Delaware, Florida, Maryland, Missouri, New Jersey, New York, Ohio, Pennsylvania, Tennessee, and Virginia","Z-0281-2014","Class II","Ray Station Radiation Therapy Treatment Planning System, Model Numbers 3.0, 3.5 and 4.0","Software version and build numbers 3.0.0.251, 3.5.0.16, 3.5.1.6, 4.0.0.14, 4.0.1.4.",".","195 units domestically","Ray Search Laboratories found an issue with the dose calculation for Elekta motorized wedges in Ray Station 3.0, 3.5 and 4.0. The error presents when a wedge is used for a beam and the wedge angle differs from 60 degrees. ",10/23/2013,"10/23/2013",11/20/2013,"11/20/2013"
"Devices",66601,"Ongoing","Philips Medical Systems (Cleveland) Inc","Cleveland","OH","US","Voluntary: Firm Initiated","Letter","Worldwide distribution: USA (nationwide) Distribution in the states of DC, GA, IL, IN, NY and OH and the countries: Germany, Israel and Netherlands.","Z-0335-2014","Class II","Brilliance iCT Computed Tomography X-Ray System, Product Usage: The Brilliance iCT is a Computed Tomography X-Ray System intended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission data taken at different angles and planes. ","Model #728306, Serial #'s: 100016, 100018, 100019, 100020, 100021, 100022, 100023, 100024 and 100025.",,"9 units","If the couch, with the footrest extension attached, is positioned where the table travel is within the bore of the gantry, and the user begins to lower the couch, the footrest extension can contact the gantry cover or come in contact with the user due to the length of the accessory.",10/11/2013,"10/11/2013",11/27/2013,"11/27/2013"
"Food",66602,"Ongoing","Irwin Naturals","Los Angeles","CA","US","Voluntary: Firm Initiated","Letter","Nationwide in US","F-0118-2014","Class II","Dual Action Cleanse by Cellular Research Formulas, 60 ct, Item AN027370, UPC 7 10363 27370 5, Item AN056592HFS, UPC 7 10363 56592 3; Item DR056439, UPC 7 10363 57369 0.","Lot # T3F006",".","1271 units","Irwin Naturals is recalling Daily Digestive Enzymes and Dual Action Cleanse because they may possibly be contaminated with chloramphenicol.",10/14/2013,"10/14/2013",11/13/2013,"11/13/2013"
"Food",66602,"Ongoing","Irwin Naturals","Los Angeles","CA","US","Voluntary: Firm Initiated","Letter","Nationwide in US","F-0120-2014","Class II","Irwin Naturals Daily Digestive Enzymes 45 ct, Item IN057552, UPC Code: 7 10363 57552 6","Lot #S3C013",".","5773 units","Irwin Naturals is recalling Daily Digestive Enzymes and Dual Action Cleanse because they may possibly be contaminated with chloramphenicol.",10/14/2013,"10/14/2013",11/13/2013,"11/13/2013"
"Food",66602,"Ongoing","Irwin Naturals","Los Angeles","CA","US","Voluntary: Firm Initiated","Letter","Nationwide in US","F-0119-2014","Class II","Dual Action Cleanse by Cellular Research Formulas with Green Tea Bonus 60 ct, Item AN056906E, UPC Code: 7 10363 56906 8","Lot #T3G017",".","1686 units","Irwin Naturals is recalling Daily Digestive Enzymes and Dual Action Cleanse because they may possibly be contaminated with chloramphenicol.",10/14/2013,"10/14/2013",11/13/2013,"11/13/2013"
"Devices",66605,"Ongoing","Roche Diagnostics Operations, Inc.","Indianapolis","IN","US","Voluntary: Firm Initiated","Letter","Nationwide Distribution.","Z-0385-2014","Class II","ACCU-CHEK Aviva Combo Blood Glucose Meter (as a part of the ACCU-CHEK Aviva Combo System)\ The ACCU-CHEK Combo System is indicated for the treatment of insulin-requiring diabetes and for the quantitative measurement of glucose in fresh capillary whole blood from the finger.","AccuChek Aviva Combo meter 05075645005 packaged in Accu-Chek Combo Kit mg US/English version, 05458544001 and Accu-Chek Combo Kit mg US/Spanish version, 05504686001.",".","6,595 units","There is a software synchronization issue with the ACCU-CHEK Combo system. In rare cases, when the Manual Pump option is chosen on the ACCU-CHEK Aviva Combo meter, there is a possibility of receiving an incorrect bolus advice recommendation that may cause a temporary under delivery of insulin.",10/25/2013,"10/25/2013",12/4/2013,"12/04/2013"
"Devices",66608,"Ongoing","DeRoyal Industries Inc","Powell","TN","US","Voluntary: Firm Initiated","Letter","Nationwide Distribution","Z-0275-2014","Class II","DeRoyal (R) Surgical Eye Spears, REF 30-049, Sterile EO, Manufacturer: DeRoyal Industries, Inc. 200 DeBusk Lane, Powell, TN 37849, MADE IN GUATEMALA cleaning of fluids from surgical site in or near the eye","Lot Number 32794811 ",".","726 cases (7242 units) ","One lot of eye spears was labeled as being x-ray detectable, but contained non x-ray detectable product.",8/12/2013,"08/12/2013",11/20/2013,"11/20/2013"
"Devices",66609,"Ongoing","Ossur North America Inc","Foothill Ranch","CA","US","Voluntary: Firm Initiated","Letter","US Distribution including the states of AL, TX, NY, CA, VA, GA, WI, NC, ID and NJ.","Z-0362-2014","Class II","Fixed Offset Adapter, A-642100. The Offset Adapter is a fixed modular component which sets the tube 14.5 mm (0.57 inch) offset from the center line of the pyramid. It is made of a high-strength alloy with a pyramid receiver and is intended where there is a need to offset the tube horizontally in relation to other components. It is fully compatible with all standard 30mm prosthetic pylons. (3) Offset: 14,5mm (0.57inch). ","Item Number: A-642100 All Serial Numbers. ",,"66 units","Ossur inititated a voluntary recall of the A-642100 Fixed Offset Adapter because it can develop fatigue cracks in normal use over an extended period of time and ultimately separate completely. ",10/24/2013,"10/24/2013",11/27/2013,"11/27/2013"
"Devices",66610,"Ongoing","Applied Medical Resources Corp","Rancho Santa Margarita","CA","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution: US (nationwide) and countries of: Australia, Austria, Belgium, Brazil, Canada, Chile, Colombia, Czech Republic, Denmark, Ecuador, Finland, France, Germany, Hong Kong, India, Ireland, Israel, Italy, Japan, Lebanon, Malaysia, Mexico, New Zealand, Netherlands, Norway, Peru, Poland, Portugal, Saudi Arabia, Singapore, Spain, South Africa, Sweden, Switzerland, United Arab Emirates, and United Kingdom.","Z-0183-2014","Class II","Applied Medical's Inzii 12/15mm Retrieval System. Applieds Inzii Tissue Retrieval Bag, Model Number CD004, is classified as a Class II device. It was cleared to market via 510(k) filing K060051. The retrieval bag is a disposable specimen retrieval bag intended for use as receptacle for the collection of tissue, organs, and calculi during laparoscopic procedures. Applieds CD004 has a shelf life of three years. It is provided sterile and packaged in a heat sealed Tyvek pouch.","Model Number CD004. Lot Nubmers: 1161268, 1161269, 1164934, 1168358, 1168361, 1169317, 1169318, 1170694, 1170700, 1170701, 1171214, 1172482, 1172664, 1174287, 1174793, 1174857, 1175123, 1175280, 1175472, 1176555, 1177023, 1177871, 1179069, 1179392, 1179460, 1179775, 1179890, 1180291, 1180411, 1180576, 1181647, 1181648, 1181649, 1181939, 1182760, 1182934, 1183225, 1183823, 1183957, 1184273, 1184728, 1184915, 1184916, 1187779, 1188817, 1189117, 1189957, 1190294, 1190358, 1191208, 1192057, 1192969, 1193196, 1193661, 1194010, 1194666, 1194807, 1195518, 1195727, 1195997, 1197182, 1197404, 1197832, 1198055, 1198968, 1199899, 1200658, 1200828, 1200829, 1200830, 1201739, 1201740, 1201741, 1203154, 1204054.",".","29,506 units","Applied Medical is conducting a voluntary recall of the Inzii 12/15mm retrieval system. During shipment, the retrieval system packaging has the potential to become punctured with small holes, which could compromise the sterile barrier. The likelihood of this situation to occur and result in patient harm is highly unlikely; however, out of an abundance of caution for patient safety and a commitment to provide only the highest quality products, Applied has decided to recall all potentially affected units.",10/21/2013,"10/21/2013",11/20/2013,"11/20/2013"
"Food",66611,"Ongoing","Kraft Foods Group","Northfield","IL","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","US: Nationwide (AL, AR, AZ, CA, CO, CT, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, SC, SD, TN, TX, UT, VA, WA, WI, WV, WY) + Guam + Puerto Rico","F-0404-2014","Class II","Low-Moisture Part-Skim Mozzarella String Cheese With Jalapeno Peppers, sold under Kraft brand or Polly-O brand and packaged with 12 pieces of mozzarella cheese with jalapeno peppers individually wrapped in plastic and sold in a plastic bag with a net weight of 10 oz. (283g).","All product with the ''Best When Used By'' dates between 25 OCT 2013 - 11 FEB 2014.",".","71,946 cases","Some varieties of Kraft and Polly-O String Cheese and String Cheese Twist products may spoil before their ''Best When Used By'' code dates, leading to product discoloration. The affected products all have code dates from October 25, 2013 through February 11, 2014.",10/25/2013,"10/25/2013",12/4/2013,"12/04/2013"
"Food",66611,"Ongoing","Kraft Foods Group","Northfield","IL","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","US: Nationwide (AL, AR, AZ, CA, CO, CT, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, SC, SD, TN, TX, UT, VA, WA, WI, WV, WY) + Guam + Puerto Rico","F-0402-2014","Class II","Low-Moisture Part-Skim Mozzarella String Cheese With Tomato and Basil, sold under Kraft brand or Polly-O brand and packaged with 12 pieces of mozzarella cheese with tomato and basil individually wrapped in plastic and sold in a plastic bag with a net weight of 10 oz. (283g).","All product with the ''Best When Used By'' dates between 25 OCT 2013 - 11 FEB 2014.",".","16,783 cases","Some varieties of Kraft and Polly-O String Cheese and String Cheese Twist products may spoil before their ''Best When Used By'' code dates, leading to product discoloration. The affected products all have code dates from October 25, 2013 through February 11, 2014.",10/25/2013,"10/25/2013",12/4/2013,"12/04/2013"
"Food",66611,"Ongoing","Kraft Foods Group","Northfield","IL","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","US: Nationwide (AL, AR, AZ, CA, CO, CT, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, SC, SD, TN, TX, UT, VA, WA, WI, WV, WY) + Guam + Puerto Rico","F-0401-2014","Class II","Low-Moisture Part-Skim Mozzarella String Cheese, sold under Kraft brand or Polly-O brand and packaged with either 12, 16, 24, or 48 pieces of mozzarella cheese individually wrapped in plastic and sold in a plastic bag with a net weight respectively of 12 oz. (340g), 16 oz. (1 lb.) (453 g), 24 oz. (1 lb. 8 oz.) (680g), or 48 oz. (3 lb.) (1.36 kg.).","All product with the ''Best When Used By'' dates between 25 OCT 2013 - 11 FEB 2014.",".","245,722 cases","Some varieties of Kraft and Polly-O String Cheese and String Cheese Twist products may spoil before their ''Best When Used By'' code dates, leading to product discoloration. The affected products all have code dates from October 25, 2013 through February 11, 2014.",10/25/2013,"10/25/2013",12/4/2013,"12/04/2013"
"Food",66611,"Ongoing","Kraft Foods Group","Northfield","IL","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","US: Nationwide (AL, AR, AZ, CA, CO, CT, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, SC, SD, TN, TX, UT, VA, WA, WI, WV, WY) + Guam + Puerto Rico","F-0407-2014","Class II","Low-Moisture Part-Skim Mozzarella String Cheese With Jalapeno Peppers, sold under Kraft brand and packaged with 24 pieces of mozzarella cheese with jalapeno peppers individually wrapped in plastic and sold in a cardstock display box bag with a net weight of 24 oz. (1 lb. 8 oz.) (283g).","All product with the ''Best When Used By'' dates between 25 OCT 2013 - 11 FEB 2014.",".","12,395 cases","Some varieties of Kraft and Polly-O String Cheese and String Cheese Twist products may spoil before their ''Best When Used By'' code dates, leading to product discoloration. The affected products all have code dates from October 25, 2013 through February 11, 2014.",10/25/2013,"10/25/2013",12/4/2013,"12/04/2013"
"Food",66611,"Ongoing","Kraft Foods Group","Northfield","IL","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","US: Nationwide (AL, AR, AZ, CA, CO, CT, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, SC, SD, TN, TX, UT, VA, WA, WI, WV, WY) + Guam + Puerto Rico","F-0403-2014","Class II","Low-Moisture Part-Skim Mozzarella String Cheese With Tomato and Italian Style Seasonings, sold under Kraft brand or Polly-O brand and packaged with 12 pieces of mozzarella cheese with tomato and Italian style seasoning individually wrapped in plastic and sold in a plastic bag with a net weight of 9 oz. (255g).","All product with the ''Best When Used By'' dates between 25 OCT 2013 - 11 FEB 2014.",".","10,068 cases","Some varieties of Kraft and Polly-O String Cheese and String Cheese Twist products may spoil before their ''Best When Used By'' code dates, leading to product discoloration. The affected products all have code dates from October 25, 2013 through February 11, 2014.",10/25/2013,"10/25/2013",12/4/2013,"12/04/2013"
"Food",66611,"Ongoing","Kraft Foods Group","Northfield","IL","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","US: Nationwide (AL, AR, AZ, CA, CO, CT, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, SC, SD, TN, TX, UT, VA, WA, WI, WV, WY) + Guam + Puerto Rico","F-0405-2014","Class II","Low-Moisture Part-Skim Mozzarella String Cheese With Cracked Pepper, sold under Kraft brand or Polly-O brand and packaged with 12 pieces of mozzarella cheese with cracked pepper individually wrapped in plastic and sold in a plastic bag with a net weight of 10 oz. (283g).","All product with the ''Best When Used By'' dates between 25 OCT 2013 - 11 FEB 2014.",".","21,169 cases","Some varieties of Kraft and Polly-O String Cheese and String Cheese Twist products may spoil before their ''Best When Used By'' code dates, leading to product discoloration. The affected products all have code dates from October 25, 2013 through February 11, 2014.",10/25/2013,"10/25/2013",12/4/2013,"12/04/2013"
"Food",66611,"Ongoing","Kraft Foods Group","Northfield","IL","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","US: Nationwide (AL, AR, AZ, CA, CO, CT, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, SC, SD, TN, TX, UT, VA, WA, WI, WV, WY) + Guam + Puerto Rico","F-0400-2014","Class II","Mozzarella String Cheese made with 2% milk for 1/4 less fat, sold under Kraft brand or Polly-O brand and packaged with either 12 or 24 pieces of mozzarella cheese individually wrapped in plastic and sold in a plastic bag with a net weight respectively of 10 oz. (283g) or 20 oz. (1 lb. 4 oz.) 566g.","All product with the ''Best When Used By'' dates between 25 OCT 2013 - 11 FEB 2014.",".","369,502 cases","Some varieties of Kraft and Polly-O String Cheese and String Cheese Twist products may spoil before their ''Best When Used By'' code dates, leading to product discoloration. The affected products all have code dates from October 25, 2013 through February 11, 2014.",10/25/2013,"10/25/2013",12/4/2013,"12/04/2013"
"Food",66611,"Ongoing","Kraft Foods Group","Northfield","IL","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","US: Nationwide (AL, AR, AZ, CA, CO, CT, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, SC, SD, TN, TX, UT, VA, WA, WI, WV, WY) + Guam + Puerto Rico","F-0406-2014","Class II","Low-Moisture Part-Skim Mozzarella String Cheese With Barbecue Seasoning, sold under Kraft brand or Polly-O brand and packaged with 12 pieces of mozzarella cheese with barbecue seasoning individually wrapped in plastic and sold in a plastic bag with a net weight of 9 oz. (255g).","All product with the ''Best When Used By'' dates between 25 OCT 2013 - 11 FEB 2014.",".","3,705 cases","Some varieties of Kraft and Polly-O String Cheese and String Cheese Twist products may spoil before their ''Best When Used By'' code dates, leading to product discoloration. The affected products all have code dates from October 25, 2013 through February 11, 2014.",10/25/2013,"10/25/2013",12/4/2013,"12/04/2013"
"Biologics",66612,"Terminated","CSL Plasma","Fort Worth","TX","US","Voluntary: Firm Initiated","Other","IL","B-0128-14","Class II","Source Plasma","41905616119; 41905601785",".","2 units","Blood products, in which donor testing was not performed or incomplete, were distributed. ",8/13/2013,"08/13/2013",12/26/2013,"12/26/2013"
"Biologics",66613,"Terminated","Penrose-St Francis Health Services Blood Bank","Colorado Springs","CO","US","Voluntary: Firm Initiated","FAX","CO","B-0129-14","Class II","Red Blood Cells","2299407",".","1 units","Blood products, collected from a donor who reported a history of Hepatitis, were distributed.",10/4/2013,"10/04/2013",12/26/2013,"12/26/2013"
"Biologics",66613,"Terminated","Penrose-St Francis Health Services Blood Bank","Colorado Springs","CO","US","Voluntary: Firm Initiated","FAX","CO","B-0130-14","Class II","Fresh Frozen Plasma","2299407",".","1 units","Blood products, collected from a donor who reported a history of Hepatitis, were distributed.",10/4/2013,"10/04/2013",12/26/2013,"12/26/2013"
"Biologics",66614,"Terminated","OneBlood, Inc.","Hialeah","FL","US","Voluntary: Firm Initiated","Letter","FL, NY","B-0125-14","Class II","Cryoprecipitated AHF","1301210",".","1 unit","Blood products, collected from a donor in which donor suitability was not adequately determined, were distributed.",9/24/2013,"09/24/2013",12/26/2013,"12/26/2013"
"Biologics",66614,"Terminated","OneBlood, Inc.","Hialeah","FL","US","Voluntary: Firm Initiated","Letter","FL, NY","B-0126-14","Class II","Platelets Pooled Leukocytes Reduced","1301210",".","1 unit","Blood products, collected from a donor in which donor suitability was not adequately determined, were distributed.",9/24/2013,"09/24/2013",12/26/2013,"12/26/2013"
"Biologics",66614,"Terminated","OneBlood, Inc.","Hialeah","FL","US","Voluntary: Firm Initiated","Letter","FL, NY","B-0127-14","Class II","Platelets","1301210",".","1 unit","Blood products, collected from a donor in which donor suitability was not adequately determined, were distributed.",9/24/2013,"09/24/2013",12/26/2013,"12/26/2013"
"Biologics",66615,"Terminated","OneBlood, Inc.","Hialeah","FL","US","Voluntary: Firm Initiated","Letter","FL","B-0122-14","Class II","Platelets Pheresis Leukocytes Reduced","1511568",".","1 unit","Blood products, collected from a donor for whom donor suitability was not adequately determined, were distributed.",9/24/2013,"09/24/2013",12/26/2013,"12/26/2013"
"Biologics",66615,"Terminated","OneBlood, Inc.","Hialeah","FL","US","Voluntary: Firm Initiated","Letter","FL","B-0120-14","Class II","Platelets Leukocytes Reduced","1481439",".","1 unit","Blood products, collected from a donor for whom donor suitability was not adequately determined, were distributed.",9/24/2013,"09/24/2013",12/26/2013,"12/26/2013"
"Biologics",66615,"Terminated","OneBlood, Inc.","Hialeah","FL","US","Voluntary: Firm Initiated","Letter","FL","B-0121-14","Class II","Red Blood Cells Leukocytes Reduced Irradiated","1481439; 1511452",".","2 units","Blood products, collected from a donor for whom donor suitability was not adequately determined, were distributed.",9/24/2013,"09/24/2013",12/26/2013,"12/26/2013"
"Biologics",66616,"Terminated","Blood Bank Of San Bernardino And Riverside Counties","San Bernardino","CA","US","Voluntary: Firm Initiated","Telephone","CA","B-0132-14","Class II","Platelets Pheresis Leukocytes Reduced","W125613607393",".","1 unit","Blood product, which was not quarantined subsequent to receiving information regarding a post donation illness, was distributed.",9/18/2013,"09/18/2013",12/26/2013,"12/26/2013"
"Biologics",66617,"Terminated","Aurora Area Blood Bank Dba Heartland Blood Centers","Aurora","IL","US","Voluntary: Firm Initiated","Letter","IL","B-0131-14","Class II","Red Blood Cells","W0397137371542",".","1 unit","Blood product, collected from a donor who traveled to a malarial endemic area, was distributed. ",8/16/2013,"08/16/2013",12/26/2013,"12/26/2013"
"Biologics",66618,"Terminated","The Blood Connection, Inc.","Piedmont","SC","US","Voluntary: Firm Initiated","Telephone","KY","B-0164-14","Class II","Platelets Pheresis Leukocytes Reduced","W121613905701",".","1 unit","Blood product, collected from a donor in which donor suitability was not adequately determined, was distributed.",9/25/2013,"09/25/2013",12/26/2013,"12/26/2013"
"Food",66621,"Ongoing","Lsg Food World Inc","Bayonne","NJ","US","Voluntary: Firm Initiated","Letter","NY","F-1106-2014","Class II","NOODLES HOUSE HOME STYLE NOODLES, Net Wt. 912 g (32 oz), product is packaged in plastic bag with twelve (12) bags per carton. UPC 6 949682 801731. *1st label indicates: Manufactured by: JINYYIFAN(HK)INTERNATIONAL LIMITED RM3.8/F., YUEXIU BLDG., 160-174 LOCKHART ROAD, WAN CHAI, HK. Distributed by: CHANG RONG INTL BAYONNE NJ 11213. PRODUCT OF CHINA. *2nd label indicates: Manufactured by: S&M(HK) ENTERPRISE LTD. RM3.8/F., YUEXIU BLDG., 160-174 LOCKHART ROAD, WAN CHAI, HK. Distributed by: S&M INT'L INC 100 PULASKI ST, BAYONNE NJ 07002. PRODUCT OF CHINA.","Item No. 801731, Best Before: 01/29/2014 and 03/22/2014",".","3068 cartons at a minimum","LSG Food World Inc., has recalled Noodles House Home Style Noodles due to use of unapproved color and undeclared food additive. ",10/18/2013,"10/18/2013",12/26/2013,"12/26/2013"
"Food",66621,"Ongoing","Lsg Food World Inc","Bayonne","NJ","US","Voluntary: Firm Initiated","Letter","NY","F-1109-2014","Class II","NOODLES HOUSE HOME STYLE NOODLES, Net Wt. 900 g (31.7 oz), product is packaged in plastic bag with twelve (12) bags per carton. UPC 6 949682 801755; Manufactured by: S&M(HK) ENTERPRISE LTD. RM3.8/F., YUEXIU BLDG., 160-174 LOCKHART ROAD, WAN CHAI, HK. Distributed by: S&M INT'L INC 100 PULASKI ST, BAYONNE NJ 07002. PRODUCT OF CHINA..","Item No. 801755, Best Before 01/29/2014",".","exact quantity cannot be determined","LSG Food World Inc., has recalled Noodles House Home Style Noodles due to use of unapproved color and undeclared food additive. ",10/18/2013,"10/18/2013",12/26/2013,"12/26/2013"
"Food",66621,"Ongoing","Lsg Food World Inc","Bayonne","NJ","US","Voluntary: Firm Initiated","Letter","NY","F-1107-2014","Class II","NOODLES HOUSE HOME STYLE NOODLES, Net Wt. 912 g (32 oz), product is packaged in plastic bag with twelve (12) bags per carton. UPC 6 949682 801724; *1st label indicates: Manufactured by: JINYYIFAN(HK)INTERNATIONAL LIMITED RM3.8/F., YUEXIU BLDG., 160-174 LOCKHART ROAD, WAN CHAI, HK. Distributed by: CHANG RONG INTL BAYONNE NJ 11213. PRODUCT OF CHINA. *2nd label indicates: Manufactured by: S&M(HK) ENTERPRISE LTD. RM3.8/F., YUEXIU BLDG., 160-174 LOCKHART ROAD, WAN CHAI, HK. Distributed by: S&M INT'L INC 100 PULASKI ST, BAYONNE NJ 07002. PRODUCT OF CHINA..","Item No. 801724, Best Before: 01/29/14 and 04/09/2014",".","1025 cartons at a minimum","LSG Food World Inc., has recalled Noodles House Home Style Noodles due to use of unapproved color and undeclared food additive. ",10/18/2013,"10/18/2013",12/26/2013,"12/26/2013"
"Food",66621,"Ongoing","Lsg Food World Inc","Bayonne","NJ","US","Voluntary: Firm Initiated","Letter","NY","F-1108-2014","Class II","NOODLES HOUSE HOME STYLE NOODLES, Net Wt. 900 g (31.7 oz), product is packaged in plastic bag with twelve (12) bags per carton. UPC 6 949682 801748; Manufactured by: S&M(HK) ENTERPRISE LTD. RM3.8/F., YUEXIU BLDG., 160-174 LOCKHART ROAD, WAN CHAI, HK. Distributed by: S&M INT'L INC 100 PULASKI ST, BAYONNE NJ 07002. PRODUCT OF CHINA..","Item No. 801748, Best Before 01/29/2014",".","exact quantity cannot be determined","LSG Food World Inc., has recalled Noodles House Home Style Noodles due to use of unapproved color and undeclared food additive. ",10/18/2013,"10/18/2013",12/26/2013,"12/26/2013"
"Food",66623,"Ongoing","Garden-Fresh Foods, Inc.","Milwaukee","WI","US","Voluntary: Firm Initiated","Letter","nationwide","F-0418-2014","Class I","Market Pantry American Style Potato Salad, UPC 0 85239 24107 3, 16 oz, Product Code 24107. Garden-Fresh American Potato Salad, UPC 0 11596 14015 5, 16 oz, Product Code 4015. Spartan American Potato Salad, UPC 0 11213 90320 0, 16 oz, Product Code 4070. Market Pantry American Potato Salad, UPC 0 85239 24102 8, 3 lb. Product Code 24102. Garden-Fresh American Potato Salad, UPC 0 11596 24200 2, 2 lb., Product Code 4200. Garden-Fresh American Potato Salad, UPC 0 11596 34310 5, 3 lb, .Product Code 4310. Garden-Fresh American Potato Salad, UPC 0 11596 51010 1, 2/5 lb., Product Code 1010. Garden-Fresh Large Diced American Potato Salad, UPC 0 11596 91018 5, 2/5 lb., Product Code 1018","Code Date: 24107 = 9/28/2013 - 10/15/2013 4015 = 9/24/2013 - 10/10/2013 4070 = 09/24/2013 - 10/02/2013 24102 = 9/30/2013 - 10/15/2013 4200 = 10/3/2013 4310 =9/28/2013 - 10/10/2013 1010 =9/28/2013 - 10/10/2013 1018.=10/1/2013 - 10/4/2013",,"94,346 total cases, for all varieties","Garden-Fresh Foods is recalling various ready-to-eat salads, slaw, and dip products sold under various brands and codes because they may be contaminated with Listeria monocytogenes.",9/20/2013,"09/20/2013",12/18/2013,"12/18/2013"
"Food",66623,"Ongoing","Garden-Fresh Foods, Inc.","Milwaukee","WI","US","Voluntary: Firm Initiated","Letter","nationwide","F-0433-2014","Class I","Weis Old Fashion Cole Slaw, UPC 0 41497 05849 5, 16 oz, Product Code 05849. Weis Old Fashion Coleslaw, UPC 0 11596 53100 7, 2/5 lb., Product Code 3100.","Code Date 05849 = 09/24/2013 - 10/10/2013. 3100.= 10/2/2013 ",,"94,346 total cases, for all varieties","Garden-Fresh Foods is recalling various ready-to-eat salads, slaw, and dip products sold under various brands and codes because they may be contaminated with Listeria monocytogenes.",9/20/2013,"09/20/2013",12/18/2013,"12/18/2013"
"Food",66623,"Ongoing","Garden-Fresh Foods, Inc.","Milwaukee","WI","US","Voluntary: Firm Initiated","Letter","nationwide","F-0423-2014","Class I","Grandpa's Red Skin Potato Salad, UPC 0 11596 14061 2, 16 oz, Product Code 4061. Weis Red Potato Salad, UPC 0 41497 05848 8, 16 oz, Product Code 05848. Portillo's Gourmet Red Skin Potato Salad, UPC 0 11596 14060 5, 16 oz, Product code4060. Weis Red Potato Salad, UPC 0 11596 51105 4, 2/5 lb., Product Code 1105. Grandpa's Red Skin Potato Salad, UPC 0 11596 51080 4, 2/5 lb., Product Code 1080","Code Date 4061 = 9/24/2013 - 10/9/2013; 05848 = 09/24/2013 - 10/08/2013; 05848 = 9/26/2013 - 10/10/2013. 1105.-=10/2/2013 - 10/9/2013 1080. =10/3/2013 ",,"94,346 total cases, for all varieties","Garden-Fresh Foods is recalling various ready-to-eat salads, slaw, and dip products sold under various brands and codes because they may be contaminated with Listeria monocytogenes.",9/20/2013,"09/20/2013",12/18/2013,"12/18/2013"
"Food",66623,"Ongoing","Garden-Fresh Foods, Inc.","Milwaukee","WI","US","Voluntary: Firm Initiated","Letter","nationwide","F-0420-2014","Class I","Archer Farms Steakhouse Potato, UPC 0 85239 40219 1, 16 oz, Product Code 402191. Archer Farms Steakhouse Potato, UPC 0 85239 40218 4, 8 oz, Product Code 402184. Grandpa's Steakhouse Potato Salad, UPC 0 11596 14068 1, 16 oz, Product Code 4068, ","Code Date 402191= 9/28/2013 - 10/14/2013 402184 = 09/22/2013 - 10/14/2013 4068 = 9/24/2013 - 10/9/2013 ",,"94,346 total cases, for all varieties","Garden-Fresh Foods is recalling various ready-to-eat salads, slaw, and dip products sold under various brands and codes because they may be contaminated with Listeria monocytogenes.",9/20/2013,"09/20/2013",12/18/2013,"12/18/2013"
"Food",66623,"Ongoing","Garden-Fresh Foods, Inc.","Milwaukee","WI","US","Voluntary: Firm Initiated","Letter","nationwide","F-0456-2014","Class I","Rogge's White Potato Salad, UPC 0 11596 51052 1, 2/5 lb. , Product Code 1052. ","Date Code: 1052.= 9/29/2013 ",,"94,346 total cases, for all varieties","Garden-Fresh Foods is recalling various ready-to-eat salads, slaw, and dip products sold under various brands and codes because they may be contaminated with Listeria monocytogenes.",9/20/2013,"09/20/2013",12/18/2013,"12/18/2013"
"Food",66623,"Ongoing","Garden-Fresh Foods, Inc.","Milwaukee","WI","US","Voluntary: Firm Initiated","Letter","nationwide","F-0467-2014","Class I","Garden-Fresh Broccoli Cheese Salad Base, UPC 0 11596 55136 4, 1/5.25 lb., Product Code 5136. 9/30/2013 - 10/4/2013 ","Code Date 5136. = 9/30/2013 - 10/4/2013 ",,"94,346 total cases, for all varieties","Garden-Fresh Foods is recalling various ready-to-eat salads, slaw, and dip products sold under various brands and codes because they may be contaminated with Listeria monocytogenes.",9/20/2013,"09/20/2013",12/18/2013,"12/18/2013"
"Food",66623,"Ongoing","Garden-Fresh Foods, Inc.","Milwaukee","WI","US","Voluntary: Firm Initiated","Letter","nationwide","F-0458-2014","Class I","Market Pantry Tuna Salad, UPC 0 85239 24108 0, 12 oz., Product Code 24108. Weis Tuna Salad, UPC 0 41497 05345 2, 6 x 8 oz, Product Code 05345","Code Date for 24108 = 9/24/2013 - 10/10/2013; 05345 = 09/24/2013 - 10/14/2013 ",,"94,346 total cases, for all varieties","Garden-Fresh Foods is recalling various ready-to-eat salads, slaw, and dip products sold under various brands and codes because they may be contaminated with Listeria monocytogenes.",9/20/2013,"09/20/2013",12/18/2013,"12/18/2013"
"Food",66623,"Ongoing","Garden-Fresh Foods, Inc.","Milwaukee","WI","US","Voluntary: Firm Initiated","Letter","nationwide","F-0425-2014","Class I","Finest Traditions Homestyle Potato Salad, UPC 7 33147 00019 9, 16 oz, Product Code 38860. Acme Homestyle Potato Salad, UPC 0 11596 91029 1, 2/5 lb. , Product Code 1029. Dairy Fresh Homemade Potato Salad, UPC XXXX, 2/5 lb., Product Code 410055. Finest Traditions Homestyle Potato Salad, UPC 7 33147 00031 1, 3 lb., Product Code 38980. Our Own Homestyle Potato Salad, UPC 0 11596 51042 2, 4/5 lb. , Product Code 1042","Code Date 38860 = 9/25/2013 - 10/10/2013. 1029.= 9/28/2013 - 10/9/2013 410055=. 10/9/2013 38980.= 10/2/2013 1042. = 9/28/2013-10/5/2013 ",,"94,346 total cases, for all varieties","Garden-Fresh Foods is recalling various ready-to-eat salads, slaw, and dip products sold under various brands and codes because they may be contaminated with Listeria monocytogenes.",9/20/2013,"09/20/2013",12/18/2013,"12/18/2013"
"Food",66623,"Ongoing","Garden-Fresh Foods, Inc.","Milwaukee","WI","US","Voluntary: Firm Initiated","Letter","nationwide","F-0426-2014","Class I","Weis Potato with Egg Salad, UPC 0 41497 05841 9, 16 oz, Product Code 05841. Weis Potato Salad with Egg, UPC 0 41497 05902 7, 3 lb., Product Code 05902. Weis Potato Salad with Egg, UPC 0 11596 51101 6, 2/5 lb., Product Code 1101","Code Date 05841 = 09/24/2013 - 10/10/2013. 05902 = 10/2/2013 - 10/10/2013 1101 = 10/2/2013 - 10/10/2013 ",,"94,346 total cases, for all varieties","Garden-Fresh Foods is recalling various ready-to-eat salads, slaw, and dip products sold under various brands and codes because they may be contaminated with Listeria monocytogenes.",9/20/2013,"09/20/2013",12/18/2013,"12/18/2013"
"Food",66623,"Ongoing","Garden-Fresh Foods, Inc.","Milwaukee","WI","US","Voluntary: Firm Initiated","Letter","nationwide","F-0453-2014","Class I","Dairy Fresh Sour Cream Mac & Cheddar, UPC 0 70163 50043 3, 2/5 lb., Product Code 410043. Garden-Fresh Sour Cream Mac & Cheddar, UPC 0 11596 92031 3, 2/5 lb. , Product Code 2031. ","Code Date 410043.-= 10/1/2013 - 10/10/2013 2031.= 10/1/2013 - 10/10/2013 ",,"94,346 total cases, for all varieties","Garden-Fresh Foods is recalling various ready-to-eat salads, slaw, and dip products sold under various brands and codes because they may be contaminated with Listeria monocytogenes.",9/20/2013,"09/20/2013",12/18/2013,"12/18/2013"
"Food",66623,"Ongoing","Garden-Fresh Foods, Inc.","Milwaukee","WI","US","Voluntary: Firm Initiated","Letter","nationwide","F-0414-2014","Class I","Garden-Fresh German Potato Salad, UPC 0 11596 14017 9, 16 oz, product code 4017 Code Date 9/25/2013 - 9/30/2013 ","9/25/2013 - 9/30/2013 ",,"94,346 total cases, for all varieties","Garden-Fresh Foods is recalling various ready-to-eat salads, slaw, and dip products sold under various brands and codes because they may be contaminated with Listeria monocytogenes.",9/20/2013,"09/20/2013",12/18/2013,"12/18/2013"
"Food",66623,"Ongoing","Garden-Fresh Foods, Inc.","Milwaukee","WI","US","Voluntary: Firm Initiated","Letter","nationwide","F-0471-2014","Class II","Garden-Fresh Creamy Cole Slaw Dressing, UPC 0 11596 43200 7, 4/2 lb., Product Code 3200. 10/26/2013 - 11/2/2013 ","Code Date 3200. = 10/26/2013 - 11/2/2013 ",,"94,346 total cases, for all varieties","Garden-Fresh Foods is recalling various ready-to-eat salads, slaw, and dip products sold under various brands and codes because they may be contaminated with Listeria monocytogenes.",9/20/2013,"09/20/2013",12/18/2013,"12/18/2013"
"Food",66623,"Ongoing","Garden-Fresh Foods, Inc.","Milwaukee","WI","US","Voluntary: Firm Initiated","Letter","nationwide","F-0455-201","Class I","Garden-Fresh Amish Country Cole Slaw, UPC 0 11596 53010 9, 2/5 lb., Product Code 3010. ","Code Date: 3010.= 9/30/2013 ",,"94,346 total cases, for all varieties","Garden-Fresh Foods is recalling various ready-to-eat salads, slaw, and dip products sold under various brands and codes because they may be contaminated with Listeria monocytogenes.",9/20/2013,"09/20/2013",12/18/2013,"12/18/2013"
"Food",66623,"Ongoing","Garden-Fresh Foods, Inc.","Milwaukee","WI","US","Voluntary: Firm Initiated","Letter","nationwide","F-0432-2014","Class I","Garden-Fresh Creamy Cole Slaw, UPC 0 11596 14022 3, 16 oz, Product Code 4022. Weis Creamy Coleslaw, UPC 0 41497 05906 5, 3 lb., Product Code 05906. Weis Creamy Coleslaw, UPC 0 11596 53101 4, 2/5 lb., Product Code 3101. Copperwood Kitchens Creamy Chopped Cole Slaw, UPC 8 11839 01020 3, 2/5 lb., Product Code 01020. Garden-Fresh Creamy Shredded Cole Slaw, UPC 0 11596 24203 3, 2 lb., Product Code 4203. Garden-Fresh Creamy Shredded Cole Slaw, UPC 0 11596 34309 9, 3 lb.,Product Code 4309. Garden-Fresh Creamy Shredded Cole Slaw, UPC 0 11596 93014 5, 2/5 lb., Product Code 3014. ","Code Date 4022 = 9/25/2013 - 10/9/2013. 05906 = 10/1/2013 - 10/2/2013 3101.= 9/30/2013 - 10/10/2013 01020. = 10/1/2013 - 10/9/2013 4203. 9/28/2013 - 10/4/2013 43 09=. 9/28/2013 - 10/10/2013 3014.= 9/30/2013 - 10/10/2013 ",,"94,346 total cases, for all varieties","Garden-Fresh Foods is recalling various ready-to-eat salads, slaw, and dip products sold under various brands and codes because they may be contaminated with Listeria monocytogenes.",9/20/2013,"09/20/2013",12/18/2013,"12/18/2013"
"Food",66623,"Ongoing","Garden-Fresh Foods, Inc.","Milwaukee","WI","US","Voluntary: Firm Initiated","Letter","nationwide","F-0434-2014","Class I","Market Pantry Italian Style Pasta Salad, UPC 0 85239 20119 0, 14 oz, Product Code 201190. ","Code Date9/20/2013 - 10/9/2013",,"94,346 total cases, for all varieties","Garden-Fresh Foods is recalling various ready-to-eat salads, slaw, and dip products sold under various brands and codes because they may be contaminated with Listeria monocytogenes.",9/20/2013,"09/20/2013",12/18/2013,"12/18/2013"
"Food",66623,"Ongoing","Garden-Fresh Foods, Inc.","Milwaukee","WI","US","Voluntary: Firm Initiated","Letter","nationwide","F-0436-2014","Class I","Market Pantry Egg Salad, UPC 0 85239 24109 7, 12 oz., Product Code 24109, Weis Egg Salad, UPC 0 11596 55221 7, 1/5 lb., Product Code 5221. Garden-Fresh Egg Salad, UPC 0 11596 52022 3, 1/5 lb. , Product Code 2022. . ","Code Date 24109 = 9/26/2013. 5221.= 9/28/2013 - 10/5/2013 2022.= 9/29/2013 - 10/5/2013 ",,"94,346 total cases, for all varieties","Garden-Fresh Foods is recalling various ready-to-eat salads, slaw, and dip products sold under various brands and codes because they may be contaminated with Listeria monocytogenes.",9/20/2013,"09/20/2013",12/18/2013,"12/18/2013"
"Food",66623,"Ongoing","Garden-Fresh Foods, Inc.","Milwaukee","WI","US","Voluntary: Firm Initiated","Letter","nationwide","F-0447-2014","Class I","Finest Traditions Southwest Dip, UPC 7 33147 10540 5, 8 oz , Product Code 38996","Code Date 9/23/2013 - 10/10/2013",,"94,346 total cases, for all varieties","Garden-Fresh Foods is recalling various ready-to-eat salads, slaw, and dip products sold under various brands and codes because they may be contaminated with Listeria monocytogenes.",9/20/2013,"09/20/2013",12/18/2013,"12/18/2013"
"Food",66623,"Ongoing","Garden-Fresh Foods, Inc.","Milwaukee","WI","US","Voluntary: Firm Initiated","Letter","nationwide","F-0446-2014","Class II","Fresh Salsa Serrano Spicy, UPC 0 11596 06143 6, 15 oz, Product Code 6143","Code Date 9/28/2013",,"94,346 total cases, for all varieties","Garden-Fresh Foods is recalling various ready-to-eat salads, slaw, and dip products sold under various brands and codes because they may be contaminated with Listeria monocytogenes.",9/20/2013,"09/20/2013",12/18/2013,"12/18/2013"
"Food",66623,"Ongoing","Garden-Fresh Foods, Inc.","Milwaukee","WI","US","Voluntary: Firm Initiated","Letter","nationwide","F-0454-2914","Class I","Archer Farms Broccoli Bacon Toss Kit, UPC 0 85239 24105 9, 2/2.35 lb., Product Code 040409","Code Date: 040409 = 10/6/2013 - 10/14/2013 ",,"94,346 total cases, for all varieties","Garden-Fresh Foods is recalling various ready-to-eat salads, slaw, and dip products sold under various brands and codes because they may be contaminated with Listeria monocytogenes.",9/20/2013,"09/20/2013",12/18/2013,"12/18/2013"
"Food",66623,"Ongoing","Garden-Fresh Foods, Inc.","Milwaukee","WI","US","Voluntary: Firm Initiated","Letter","nationwide","F-0468-201","Class I","Garden-Fresh Foods Broccoli Cheese Salad Kit, UPC 0 11596 93038 1, 1/11.25 lb., Product Code 3038. 9/30/2013 ","Code Date 3038. = 9/30/2013 ",,"94,346 total cases, for all varieties","Garden-Fresh Foods is recalling various ready-to-eat salads, slaw, and dip products sold under various brands and codes because they may be contaminated with Listeria monocytogenes.",9/20/2013,"09/20/2013",12/18/2013,"12/18/2013"
"Food",66623,"Ongoing","Garden-Fresh Foods, Inc.","Milwaukee","WI","US","Voluntary: Firm Initiated","Letter","nationwide","F-0415-2014","Class I","Market Pantry Macaroni Salad, UPC 0 85239 24105 9, 16 oz, Product Code 24105. Weis Original Macaroni Salad, UPC 0 41497 05839 6, 16 oz, Product Code 5839. Spartan Macaroni Salad, UPC 0 11213 90321 7, 16 oz, Product Code 4073. Grandpa's Macaroni Salad, UPC 0 11596 14066 7, 16 oz, Product Code 4066. Finest Traditions Macaroni Salad, UPC 7 33147 00018 2, 16 oz, Product Code 38856. 9 Market Pantry Macaroni Salad, UPC 0 85239 24101 1, 3 lb. , Product Code 24101. Weis Original Macaroni Salad, UPC 0 41497 05904 1, 3 lb. Product Code 05904. Weis Original Macaroni Salad, UPC 0 11596 52106 0, 2/5 lb., Product Code 2106. Dairy Fresh Macaroni Salad, UPC 0 70163 56415 2, 2/5 lb. , Product Code 407364. Family Style Macaroni Salad, UPC 0 11596 52060 5, 2/5 lb., Product code 2060. Garden-Fresh Macaroni Salad, UPC 0 11596 34305 1, 3 lb., Product Code 4305. Garden-Fresh Macaroni Salad, UPC 0 11596 52005 6, 2/5 lb., Product Code 2005. Spoon River Signature Macaroni Salad, UPC 0 11596 55690 1, 2/5 lb., Product Code 5690. ","Code Date: 24105 = 9/24/2013 - 10/10/2013 5839 = 09/24/2013 - 10/10/2013 4073 = 09/23/2013 - 10/10/2013 4066 = 9/23/2013 - 10/9/2013 38856 = 9/23/2013 - 10/3/2013 24101 = 10/2/2013 - 10/13/2013 05904 = 10/2/2013 - 10/10/2013 2106 = 10/2/2013 - 10/10/2013 407364 = 10/1/2013 2060 = 9/30/2013 - 10/10/2013 4305 =9/30/2013 - 10/10/2013 2005 = 9/30/2013 - 10/10/2013 5690.= 10/4/2013 ",,"94,346 total cases, for all varieties","Garden-Fresh Foods is recalling various ready-to-eat salads, slaw, and dip products sold under various brands and codes because they may be contaminated with Listeria monocytogenes.",9/20/2013,"09/20/2013",12/18/2013,"12/18/2013"
"Food",66623,"Ongoing","Garden-Fresh Foods, Inc.","Milwaukee","WI","US","Voluntary: Firm Initiated","Letter","nationwide","F-0477-2014","Class I","Garden-Fresh Taco Pasta Salad, UPC 0 11596 52076 6, 1/5 lb., Product Code 2076. 10/1/2013 ","Code Date 2076.= 10/1/2013 ",,"94,346 total cases, for all varieties","Garden-Fresh Foods is recalling various ready-to-eat salads, slaw, and dip products sold under various brands and codes because they may be contaminated with Listeria monocytogenes.",9/20/2013,"09/20/2013",12/18/2013,"12/18/2013"
"Food",66623,"Ongoing","Garden-Fresh Foods, Inc.","Milwaukee","WI","US","Voluntary: Firm Initiated","Letter","nationwide","F-0475-2014","Class I","Garden-Fresh Seven Layer Salad Kit, UPC 0 11596 85161 7, 2/3.25 lb., Product Code 5161. 10/11/2013 ","Code Date 5161. = 10/11/2013 ",,"94,346 total cases, for all varieties","Garden-Fresh Foods is recalling various ready-to-eat salads, slaw, and dip products sold under various brands and codes because they may be contaminated with Listeria monocytogenes.",9/20/2013,"09/20/2013",12/18/2013,"12/18/2013"
"Food",66623,"Ongoing","Garden-Fresh Foods, Inc.","Milwaukee","WI","US","Voluntary: Firm Initiated","Letter","nationwide","F-0452-2014","Class I","Dairy Fresh Homemade Mustard Potato Salad, UPC 0 70163 56700 9, 2/5 lb., Product Code 410059. Our Own Homestyle Mustard Potato Salad, UPC 0 11596 51047 7, 4/5 lb., Product Code 1047. ","Date Code 410059. = 9/29/2013. 1047 = 10/3/2013 - 10/4/2013 ",,"94,346 total cases, for all varieties","Garden-Fresh Foods is recalling various ready-to-eat salads, slaw, and dip products sold under various brands and codes because they may be contaminated with Listeria monocytogenes.",9/20/2013,"09/20/2013",12/18/2013,"12/18/2013"
"Food",66623,"Ongoing","Garden-Fresh Foods, Inc.","Milwaukee","WI","US","Voluntary: Firm Initiated","Letter","nationwide","F-0473-2014","Class I","Garden-Fresh Gourmet Dill Potato Salad, UPC 0 11596 55137 1, 2/5 lb., Product Code 5137. 10/4/2013 ","Code Date 5137=. 10/4/2013 ",,"94,346 total cases, for all varieties","Garden-Fresh Foods is recalling various ready-to-eat salads, slaw, and dip products sold under various brands and codes because they may be contaminated with Listeria monocytogenes.",9/20/2013,"09/20/2013",12/18/2013,"12/18/2013"
"Food",66623,"Ongoing","Garden-Fresh Foods, Inc.","Milwaukee","WI","US","Voluntary: Firm Initiated","Letter","nationwide","F-0462-2014","Class I","Weis Amish Macaroni Salad, UPC 0 41497 05844 0, 16 oz, Product Code 05844. Weis Amish Macaroni Salad, UPC 0 41497 05905 8, 3 lb. Product Code 05905. Weis Amish Macaroni Salad, UPC 0 11596 52105 3, 2/5 lb., Product Code 2105. Garden-Fresh Amish Country Macaroni Salad, UPC 0 11596 52010 0, 2/5 lb., Product Code 2010","Product Code = Code Date 05844 = 09/24/2013 - 10/10/2013 05905 = 10/2/2013 - 10/10/2013 2105 = 9/30/2013 - 10/3/2013. 2010.= 10/2/2013-10/09/2013 ",,"94,346 total cases, for all varieties","Garden-Fresh Foods is recalling various ready-to-eat salads, slaw, and dip products sold under various brands and codes because they may be contaminated with Listeria monocytogenes.",9/20/2013,"09/20/2013",12/18/2013,"12/18/2013"
"Food",66623,"Ongoing","Garden-Fresh Foods, Inc.","Milwaukee","WI","US","Voluntary: Firm Initiated","Letter","nationwide","F-0472-2014","Class I","Garden-Fresh Dixie Style Cole Slaw, UPC 0 11596 93007 7, 2/5 lb., Product Code 3007. 9/30/2013 - 10/10/2013 ","Code Date 3007=. 9/30/2013 - 10/10/2013 ",,"94,346 total cases, for all varieties","Garden-Fresh Foods is recalling various ready-to-eat salads, slaw, and dip products sold under various brands and codes because they may be contaminated with Listeria monocytogenes.",9/20/2013,"09/20/2013",12/18/2013,"12/18/2013"
"Food",66623,"Ongoing","Garden-Fresh Foods, Inc.","Milwaukee","WI","US","Voluntary: Firm Initiated","Letter","nationwide","F-0444-2014","Class I","Roundy's Dill Dip, UPC 0 11150 52603 6, 12 oz, Product Code 52603. Finest Traditions Dill Dip, UPC 7 33147 10554 2, 8 oz, Product Code 38988","Code Date for 52603 = 10/11/2013 - 11/3/2013; 38988 = 9/23/2013 - 10/10/2013",,"94,346 total cases, for all varieties","Garden-Fresh Foods is recalling various ready-to-eat salads, slaw, and dip products sold under various brands and codes because they may be contaminated with Listeria monocytogenes.",9/20/2013,"09/20/2013",12/18/2013,"12/18/2013"
"Food",66623,"Ongoing","Garden-Fresh Foods, Inc.","Milwaukee","WI","US","Voluntary: Firm Initiated","Letter","nationwide","F-0440-2014","Class I","Archer Farms Spinach Dip, UPC 0 85239 69052 9, 11 oz, Product Code 99010. Archer Farms Spinach Dip, UPC 0 85239 69053 6, 18 oz, Product Code 69052. Finest Traditions Spinach Dip, UPC 7 33147 10538 2, 8 oz. Product Code 38992. Our Own Spinach Dip, UPC 0 11596 55149 4, 1/5 lb., Product Code 5149","Code Date 99010 / 69052 = 10/5/2013 - 10/26/2013.; 38992 =9/23/2013 - 10/10/2013 5149. =1 0/11/2013 ",,"94,346 total cases, for all varieties","Garden-Fresh Foods is recalling various ready-to-eat salads, slaw, and dip products sold under various brands and codes because they may be contaminated with Listeria monocytogenes.",9/20/2013,"09/20/2013",12/18/2013,"12/18/2013"
"Food",66623,"Ongoing","Garden-Fresh Foods, Inc.","Milwaukee","WI","US","Voluntary: Firm Initiated","Letter","nationwide","F-0469-2017","Class I","Garden-Fresh Chopped Broccoli Cauliflower Salad Base, UPC 0 11596 55188 3, 1/5.25 lb., Product Code 5188. 10/1/2013 - 10/14/2013 ","Code Date 5188.= 10/1/2013 - 10/14/2013 ",,"94,346 total cases, for all varieties","Garden-Fresh Foods is recalling various ready-to-eat salads, slaw, and dip products sold under various brands and codes because they may be contaminated with Listeria monocytogenes.",9/20/2013,"09/20/2013",12/18/2013,"12/18/2013"
"Food",66623,"Ongoing","Garden-Fresh Foods, Inc.","Milwaukee","WI","US","Voluntary: Firm Initiated","Letter","nationwide","F-0416-2014","Class I","Market Pantry Mustard Potato Salad , UPC 0 85329 24104 2, 16 oz, Product Code 24104. Garden-Fresh Mustard Potato Salad, UPC 0 11596 14010 0, 16 oz, Product Code 4010. Spartan Mustard Potato Salad, UPC 0 11213 90319 4, 16 oz, Product Code 4071. Garden-Fresh Mustard Potato Salad, UPC 0 11596 24215 6, 2 lb., Product Code 4215. Garden-Fresh Mustard Potato Salad , UPC 0 11596 34313 6, 3 lb., Product Code 4313. Garden-Fresh Mustard Potato Salad, UPC 0 11596 51013 2, 2/5 lb., Product Code 1013. Market Pantry Mustard Potato Salad, UPC 0 85239 24100 4, 3 lb., Product Code 24100. Dairy Fresh Mustard Potato Salad , UPC 0 70163 89090 9, 2/5 lb., Product Code ","Date Code 24104 = 9/25/2013 - 10/15/2013 4010 = 9/24/2013 - 10/10/2013 4071= 09/23/2013 - 10/08/2013 4215. = 10/4/2013 4313. = 9/28/2013 - 10/10/2013 1013.= 9/28/2013 - 10/10/2013 24100.= 9/30/2013 - 10/13/2013 401536= 10/1/2013 ",,"94,346 total cases, for all varieties","Garden-Fresh Foods is recalling various ready-to-eat salads, slaw, and dip products sold under various brands and codes because they may be contaminated with Listeria monocytogenes.",9/20/2013,"09/20/2013",12/18/2013,"12/18/2013"
"Food",66623,"Ongoing","Garden-Fresh Foods, Inc.","Milwaukee","WI","US","Voluntary: Firm Initiated","Letter","nationwide","F-0476-2014","Class I","Garden-Fresh Sour Cream Mac & Cheddar, UPC 0 11596 92031 3, 2/5 lb, Product Code 2031. 10/1/2013 - 10/10/2013 ","Code Date 2031.= 10/1/2013 - 10/10/2013 ",,"94,346 total cases, for all varieties","Garden-Fresh Foods is recalling various ready-to-eat salads, slaw, and dip products sold under various brands and codes because they may be contaminated with Listeria monocytogenes.",9/20/2013,"09/20/2013",12/18/2013,"12/18/2013"
"Food",66623,"Ongoing","Garden-Fresh Foods, Inc.","Milwaukee","WI","US","Voluntary: Firm Initiated","Letter","nationwide","F-0439-2014","Class I","Archer Farms Bacon Parmesan Dip, UPC 0 85239 99017 9, 11 oz, Product Code 99017. ","Code Date 10/12/2013 - 11/8/2013",,"94,346 total cases, for all varieties","Garden-Fresh Foods is recalling various ready-to-eat salads, slaw, and dip products sold under various brands and codes because they may be contaminated with Listeria monocytogenes.",9/20/2013,"09/20/2013",12/18/2013,"12/18/2013"
"Food",66623,"Ongoing","Garden-Fresh Foods, Inc.","Milwaukee","WI","US","Voluntary: Firm Initiated","Letter","nationwide","F-0435-2014","Class I","Market Pantry Baked Beans, UPC 0 85239 24110 3, 16 oz, Product Code 24110","Code Date 9/29/2013 - 10/10/2013",,"94,346 total cases, for all varieties","Garden-Fresh Foods is recalling various ready-to-eat salads, slaw, and dip products sold under various brands and codes because they may be contaminated with Listeria monocytogenes.",9/20/2013,"09/20/2013",12/18/2013,"12/18/2013"
"Food",66623,"Ongoing","Garden-Fresh Foods, Inc.","Milwaukee","WI","US","Voluntary: Firm Initiated","Letter","nationwide","F-0417-2014","Class I","Market Pantry Reduced Fat Mustard Potato Salad, UPC 0 85329 20016 2, 16 oz, Product Code 200162","Code Date 10/4/2013 - 10/18/2013",,"94,346 total cases, for all varieties","Garden-Fresh Foods is recalling various ready-to-eat salads, slaw, and dip products sold under various brands and codes because they may be contaminated with Listeria monocytogenes.",9/20/2013,"09/20/2013",12/18/2013,"12/18/2013"
"Food",66623,"Ongoing","Garden-Fresh Foods, Inc.","Milwaukee","WI","US","Voluntary: Firm Initiated","Letter","nationwide","F-0443-2014","Class I","Roundy's Taco Dip, UPC 0 11150 52604 3, 12 oz , Product Code 52604. Maggie's Taco Dip, UPC 0 11596 06201 3, 12 oz , Product Code 6201. Finest Traditions Taco Dip, UPC 7 33147 10556 6. 8 oz, Product Code 38984. ","Code Date for 52604 = 10/8/2013 - 11/4/2013; 6201= 10/8/2013 - 11/4/2013; 38984 =9/23/2013 - 10/10/2013.",,"94,346 total cases, for all varieties","Garden-Fresh Foods is recalling various ready-to-eat salads, slaw, and dip products sold under various brands and codes because they may be contaminated with Listeria monocytogenes.",9/20/2013,"09/20/2013",12/18/2013,"12/18/2013"
"Food",66623,"Ongoing","Garden-Fresh Foods, Inc.","Milwaukee","WI","US","Voluntary: Firm Initiated","Letter","nationwide","F-0430-2014","Class I","Market Pantry Reduced Fat Coleslaw, UPC 0 85239 20117 6 15 oz, Product Code 201176. ","Code Date 9/30/2013 - 10/18/2013",,"94,346 total cases, for all varieties","Garden-Fresh Foods is recalling various ready-to-eat salads, slaw, and dip products sold under various brands and codes because they may be contaminated with Listeria monocytogenes.",9/20/2013,"09/20/2013",12/18/2013,"12/18/2013"
"Food",66623,"Ongoing","Garden-Fresh Foods, Inc.","Milwaukee","WI","US","Voluntary: Firm Initiated","Letter","nationwide","F-0466-2014","Class I","Garden-Fresh Asiago Pasta, UPC 0 11596 52069 8, 1/5 lb., Product Code 2069. 10/1/2013 - 10/9/2013","Code Date 2069.= 10/1/2013 - 10/9/2013 ",,"94,346 total cases, for all varieties","Garden-Fresh Foods is recalling various ready-to-eat salads, slaw, and dip products sold under various brands and codes because they may be contaminated with Listeria monocytogenes.",9/20/2013,"09/20/2013",12/18/2013,"12/18/2013"
"Food",66623,"Ongoing","Garden-Fresh Foods, Inc.","Milwaukee","WI","US","Voluntary: Firm Initiated","Letter","nationwide","F-0438-2014","Class I","Archer Farms Smoked Salmon Dip , UPC 0 85239 99019 3, 11 oz, Product Code 99019","Code Date 10/11/2013 - 11/9/2013",,"94,346 total cases, for all varieties","Garden-Fresh Foods is recalling various ready-to-eat salads, slaw, and dip products sold under various brands and codes because they may be contaminated with Listeria monocytogenes.",9/20/2013,"09/20/2013",12/18/2013,"12/18/2013"
"Food",66623,"Ongoing","Garden-Fresh Foods, Inc.","Milwaukee","WI","US","Voluntary: Firm Initiated","Letter","nationwide","F-0449-2014","Class I","Chef's Kitchen Cucumber Dill Dip, UPC 0 11596 06180 1, 12 oz, Product Code 6180","Code Date 10/18/2013 - 11/3/2013",,"94,346 total cases, for all varieties","Garden-Fresh Foods is recalling various ready-to-eat salads, slaw, and dip products sold under various brands and codes because they may be contaminated with Listeria monocytogenes.",9/20/2013,"09/20/2013",12/18/2013,"12/18/2013"
"Food",66623,"Ongoing","Garden-Fresh Foods, Inc.","Milwaukee","WI","US","Voluntary: Firm Initiated","Letter","nationwide","F-0474-2014","Class I","Garden-Fresh Greek Style Pasta Salad, UPC 0 11596 52035 3, 1/5 lb., Product Code 2035. 9/30/2013 - 10/8/2013 ","Code Date 2035.= 9/30/2013 - 10/8/2013 ",,"94,346 total cases, for all varieties","Garden-Fresh Foods is recalling various ready-to-eat salads, slaw, and dip products sold under various brands and codes because they may be contaminated with Listeria monocytogenes.",9/20/2013,"09/20/2013",12/18/2013,"12/18/2013"
"Food",66623,"Ongoing","Garden-Fresh Foods, Inc.","Milwaukee","WI","US","Voluntary: Firm Initiated","Letter","nationwide","F-0448-2014","Class I","Finest Traditions Smoky Baked Beans,UPC 7 33147 00161 5, 16 oz, Product Code 38854","Code Date 9/23/2013 - 9/30/2013",,"94,346 total cases, for all varieties","Garden-Fresh Foods is recalling various ready-to-eat salads, slaw, and dip products sold under various brands and codes because they may be contaminated with Listeria monocytogenes.",9/20/2013,"09/20/2013",12/18/2013,"12/18/2013"
"Food",66623,"Ongoing","Garden-Fresh Foods, Inc.","Milwaukee","WI","US","Voluntary: Firm Initiated","Letter","nationwide","F-0437-2014","Class I","Archer Farms Artichoke Spinach Dip, UC 0 85239 99015 5, 11 oz, Product Code 99015. Archer Farms Artichoke Spinach Dip, UPC 0 85239 69053 6, 18 oz, Product Code 69053. Roundy's Artichoke Spinach Dip , UPC 0 11596 06170 2, 12 oz. Product Code 6170. ","Code Date for 99015 = 09/26/2013 - 10/20/2013; 69053 = 09/26/2013 - 11/2/2013; 6170 = 10/7/2013 - 11/3/2013",,"94,346 total cases, for all varieties","Garden-Fresh Foods is recalling various ready-to-eat salads, slaw, and dip products sold under various brands and codes because they may be contaminated with Listeria monocytogenes.",9/20/2013,"09/20/2013",12/18/2013,"12/18/2013"
"Food",66623,"Ongoing","Garden-Fresh Foods, Inc.","Milwaukee","WI","US","Voluntary: Firm Initiated","Letter","nationwide","F-0427-2014","Class I","Weis Amish Potato Salad, UPC 0 41497 05845 7, 16 oz, Product Code 05845. Weis Amish Potato Salad, UPC 0 41497 05901 0, 3 lb., Product Code 05901. Weis Amish Potato Salad, UPC 0 11596 51105 4, 2/5 lb., Product Code 1103. Garden-Fresh Amish Country Potato Salad, UPC 0 11596 51005 7, 2/5 lb., Product Code 1005. 9/28/2013 ","Code Date 05845 = 09/24/2013 - 10/10/2013. 05901.= 10/2/2013 - 10/10/2013 1103.= 10/2/2013 - 10/10/2013 1005.= 9/28/2013 ",,"94,346 total cases, for all varieties","Garden-Fresh Foods is recalling various ready-to-eat salads, slaw, and dip products sold under various brands and codes because they may be contaminated with Listeria monocytogenes.",9/20/2013,"09/20/2013",12/18/2013,"12/18/2013"
"Food",66623,"Ongoing","Garden-Fresh Foods, Inc.","Milwaukee","WI","US","Voluntary: Firm Initiated","Letter","nationwide","F-0459-2014","Class I","Finest Traditions Tuna Salad Spread, UPC 7 33147 10487 3 6 x 12 oz. Product code 38622. ","Code Date:10/01/2013 - 10/02/2013 ",,"94,346 total cases, for all varieties","Garden-Fresh Foods is recalling various ready-to-eat salads, slaw, and dip products sold under various brands and codes because they may be contaminated with Listeria monocytogenes.",9/20/2013,"09/20/2013",12/18/2013,"12/18/2013"
"Food",66623,"Ongoing","Garden-Fresh Foods, Inc.","Milwaukee","WI","US","Voluntary: Firm Initiated","Letter","nationwide","F-0421-2014","Class I","Grandpa's Deviled Egg Potato Salad , UPC 0 11596 14012 4, 16 oz, Product Code 4012. Grandpa's Deviled Egg Potato Salad, UPC 0 11596 51065 1, 2/5 lb., Product Code 1065. Grandpa's Deviled Egg Potato Salad, 0 00 11596 51065 1, 4/5 lb., Product Code 1068. ","Code Date 4012 = 9/24/2013 - 10/3/2013. 1065.= 10/3/2013 - 10/10/2013 1068.= 10/3/2013 - 10/10/2013 ",,"94,346 total cases, for all varieties","Garden-Fresh Foods is recalling various ready-to-eat salads, slaw, and dip products sold under various brands and codes because they may be contaminated with Listeria monocytogenes.",9/20/2013,"09/20/2013",12/18/2013,"12/18/2013"
"Food",66623,"Ongoing","Garden-Fresh Foods, Inc.","Milwaukee","WI","US","Voluntary: Firm Initiated","Letter","nationwide","F-0470-2014","Class I","Garden-Fresh Foods Chopped Broccoli Cauliflower Salad Kit , UPC 0 11596 93046 6, 1/11.25 lb., Product Code 3046. 10/2/2013 ","Code Date 3046.= 10/2/2013 ",,"94,346 total cases, for all varieties","Garden-Fresh Foods is recalling various ready-to-eat salads, slaw, and dip products sold under various brands and codes because they may be contaminated with Listeria monocytogenes.",9/20/2013,"09/20/2013",12/18/2013,"12/18/2013"
"Food",66623,"Ongoing","Garden-Fresh Foods, Inc.","Milwaukee","WI","US","Voluntary: Firm Initiated","Letter","nationwide","F-0463-2014","Class I","Grandpa's German Potato Salad, 16 oz, UPC 0 11596 14016 2, product code 4016. ","Code Date 9/23/2013 -10/18/2013",,"94,346 total cases, for all varieties","Garden-Fresh Foods is recalling various ready-to-eat salads, slaw, and dip products sold under various brands and codes because they may be contaminated with Listeria monocytogenes.",9/20/2013,"09/20/2013",12/18/2013,"12/18/2013"
"Food",66623,"Ongoing","Garden-Fresh Foods, Inc.","Milwaukee","WI","US","Voluntary: Firm Initiated","Letter","nationwide","F-0464-2014","Class I","Garden-Fresh Country Style Potato Salad, UPC 0 11596 51075 0, 2/5 lb., Product Code 1075. 10/10/2013 ","Code Date 1075.= 10/10/2013 ",,"94,346 total cases, for all varieties","Garden-Fresh Foods is recalling various ready-to-eat salads, slaw, and dip products sold under various brands and codes because they may be contaminated with Listeria monocytogenes.",9/20/2013,"09/20/2013",12/18/2013,"12/18/2013"
"Food",66623,"Ongoing","Garden-Fresh Foods, Inc.","Milwaukee","WI","US","Voluntary: Firm Initiated","Letter","nationwide","F-0460-2014","Class I","Market Pantry Reduced Fat Macaroni Salad, UPC 0 85239 20118 3, 16 oz, product code 201183. ","Code date: 10/6/2013 - 10/15/2013 ",,"94,346 total cases, for all varieties","Garden-Fresh Foods is recalling various ready-to-eat salads, slaw, and dip products sold under various brands and codes because they may be contaminated with Listeria monocytogenes.",9/20/2013,"09/20/2013",12/18/2013,"12/18/2013"
"Food",66623,"Ongoing","Garden-Fresh Foods, Inc.","Milwaukee","WI","US","Voluntary: Firm Initiated","Letter","nationwide","F-0442-2014","Class I","Archer Farms Vanilla Crme Dip, UPC 0 85239 99014 8, 12 oz, Product Code 99014. ","Code Date 10/4/2013 - 11/2/2013",,"94,346 total cases, for all varieties","Garden-Fresh Foods is recalling various ready-to-eat salads, slaw, and dip products sold under various brands and codes because they may be contaminated with Listeria monocytogenes.",9/20/2013,"09/20/2013",12/18/2013,"12/18/2013"
"Food",66623,"Ongoing","Garden-Fresh Foods, Inc.","Milwaukee","WI","US","Voluntary: Firm Initiated","Letter","nationwide","F-0441-2014","Class I","Archer Farms Feta & Roasted Red Pepper Dip, UPC 0 85239 69048 2, 11 oz, Product Code 69048","Code Date10/5/2013 - 11/2/2013",,"94,346 total cases, for all varieties","Garden-Fresh Foods is recalling various ready-to-eat salads, slaw, and dip products sold under various brands and codes because they may be contaminated with Listeria monocytogenes.",9/20/2013,"09/20/2013",12/18/2013,"12/18/2013"
"Food",66623,"Ongoing","Garden-Fresh Foods, Inc.","Milwaukee","WI","US","Voluntary: Firm Initiated","Letter","nationwide","F-0428-2014","Class I","Weis Original Potato Salad, UPC 0 41497 05838 9, 16 oz, Product Code 05383. Weis Original Potato Salad, UPC 0 41497 05900 3, 3 lb., Product Code 05900. 10/1/2013 - 10/10/2013 Weis Original Potato Salad, UPC 0 11596 51102 3, 2/5 lb., Product Code 1102. 10/1/2013 - 10/10/2013 ","Code Date 05383 = 09/24/2013 - 10/10/2013. 05900.= 10/1/2013 - 10/10/2013 1102.= 10/1/2013 - 10/10/2013 ",,"94,346 total cases, for all varieties","Garden-Fresh Foods is recalling various ready-to-eat salads, slaw, and dip products sold under various brands and codes because they may be contaminated with Listeria monocytogenes.",9/20/2013,"09/20/2013",12/18/2013,"12/18/2013"
"Food",66623,"Ongoing","Garden-Fresh Foods, Inc.","Milwaukee","WI","US","Voluntary: Firm Initiated","Letter","nationwide","F-0461-2014","Class I","Archer Farms Garlic Herb Cheese Dip, no UPC, 7 oz, Product code 6186","Code date: 11/7/2013 ",,"94,346 total cases, for all varieties","Garden-Fresh Foods is recalling various ready-to-eat salads, slaw, and dip products sold under various brands and codes because they may be contaminated with Listeria monocytogenes.",9/20/2013,"09/20/2013",12/18/2013,"12/18/2013"
"Food",66623,"Ongoing","Garden-Fresh Foods, Inc.","Milwaukee","WI","US","Voluntary: Firm Initiated","Letter","nationwide","F-0450-2014","Class I","Dairy Fresh Deluxe BLT Pasta Salad, UPC 0 70163 50074 7, 1/5 lb, Product Code .410074. Garden-Fresh Deluxe BLT Pasta Salad, UPC 0 11596 52039 1, 1/5 lb., Product Code 2039. ","Code Date 410074.= 10/1/2013 2039. = 9/30/2013 - 10/4/2013 ",,"94,346 total cases, for all varieties","Garden-Fresh Foods is recalling various ready-to-eat salads, slaw, and dip products sold under various brands and codes because they may be contaminated with Listeria monocytogenes.",9/20/2013,"09/20/2013",12/18/2013,"12/18/2013"
"Food",66623,"Ongoing","Garden-Fresh Foods, Inc.","Milwaukee","WI","US","Voluntary: Firm Initiated","Letter","nationwide","F-0419-2014","Class I","Market Pantry Reduced Fat American Potato Salad, UPC 0 85239 20115 2, 16 oz, Product Code 201152. ","Code Date10/4/2013 - 10/18/2013",,"94,346 total cases, for all varieties","Garden-Fresh Foods is recalling various ready-to-eat salads, slaw, and dip products sold under various brands and codes because they may be contaminated with Listeria monocytogenes.",9/20/2013,"09/20/2013",12/18/2013,"12/18/2013"
"Food",66623,"Ongoing","Garden-Fresh Foods, Inc.","Milwaukee","WI","US","Voluntary: Firm Initiated","Letter","nationwide","F-0429-2014","Class I","Market Pantry Coleslaw, UPC 0 85239 24106 6, 15 oz, Product Code 24106. Spartan Cole Slaw, UPC 0 11213 90322 4, 16 oz, Product Code 4072. Market Pantry Coleslaw, UPC 0 85239 24114 1, 44 oz., Product Code 24114. Family Style Cole Slaw, UPC 0 11596 53060 4, 2/5 lb., Product Code 3060. Grandpa's Cole Slaw, UPC 0 11596 08006 2, 3.5 oz, Product Code 8006. Grandpa's Cole Slaw, UPC 0 11596 24237 8, 2 lb., Product Code 4325. Grandpa's Cole Slaw, UPC 0 11596 34325 9, 3 lb., Product Code 4237. Grandpa's Cole Slaw, UPC 0 11596 93021 3, 2/5 lb., Product Code 3021. ","Code Date 24106 = 10/1/2013 - 10/13/2013; 4072 = 9/23/2013 - 10/08/2013. 24114= 10/8/2013 - 10/14 2013 3060 =9/30/2013 8006 = 10/4/2013 4325 = 10/1/2013 - 10/9/2013 4237 = 10/1/2013 - 10/4/2013 3021 = 10/1/2013 - 10/9/2013 ",,"94,346 total cases, for all varieties","Garden-Fresh Foods is recalling various ready-to-eat salads, slaw, and dip products sold under various brands and codes because they may be contaminated with Listeria monocytogenes.",9/20/2013,"09/20/2013",12/18/2013,"12/18/2013"
"Food",66623,"Ongoing","Garden-Fresh Foods, Inc.","Milwaukee","WI","US","Voluntary: Firm Initiated","Letter","nationwide","F-0424-2014","Class I","Finest Traditions Deluxe Potato Salad, UPC 7 33147 00007 6, 16 oz, Product Code 38768. Chef's Kitchen Deluxe Egg Salad, UPC 0 11596 52044 5, 1/5 lb., Product Code 2044. Finest Traditions Deluxe Potato Salad, UPC 7 33147 00030 4, 3 lb., Product Code 38768. Garden-Fresh Deluxe Egg Salad, UPC 0 11596 52043 8, 1/5 lb., Product Code 2043. ","Code Date 38768 = 9/23/2013 - 10/3/2013. 2044.= 9/29/2013 - 10/3/2013 38768. = 10/2/2013 2043.= 10/3/2013 ",,"94,346 total cases, for all varieties","Garden-Fresh Foods is recalling various ready-to-eat salads, slaw, and dip products sold under various brands and codes because they may be contaminated with Listeria monocytogenes.",9/20/2013,"09/20/2013",12/18/2013,"12/18/2013"
"Food",66623,"Ongoing","Garden-Fresh Foods, Inc.","Milwaukee","WI","US","Voluntary: Firm Initiated","Letter","nationwide","F-0457-2014","Class I","Old Tyme Sweet Bow Tie Pasta with Bacon, UPC 0 94776 03409 3, 1/5 lb., Product Code 03409. Garden-Fresh Sweet Bow Tie Pasta with Bacon, UPC 0 11 11596 52047 2, 1/5 lb., Product Code 2047. 9/30/2013 - 10/9/2013 ","Code Date: 03409.= 9/30/2013 - 10/9/2013 2047. = 9/30/2013 - 10/9/2013 ",,"94,346 total cases, for all varieties","Garden-Fresh Foods is recalling various ready-to-eat salads, slaw, and dip products sold under various brands and codes because they may be contaminated with Listeria monocytogenes.",9/20/2013,"09/20/2013",12/18/2013,"12/18/2013"
"Food",66623,"Ongoing","Garden-Fresh Foods, Inc.","Milwaukee","WI","US","Voluntary: Firm Initiated","Letter","nationwide","F-0445-2014","Class I","Maggie's White Fruit Dip, UPC 0 11596 06200 6, 12 oz, Product Code 6200. ","Code Date 9/25/2013 - 10/3/2013",,"94,346 total cases, for all varieties","Garden-Fresh Foods is recalling various ready-to-eat salads, slaw, and dip products sold under various brands and codes because they may be contaminated with Listeria monocytogenes.",9/20/2013,"09/20/2013",12/18/2013,"12/18/2013"
"Food",66623,"Ongoing","Garden-Fresh Foods, Inc.","Milwaukee","WI","US","Voluntary: Firm Initiated","Letter","nationwide","F-0422-2014","Class I","Grandpa's Potato Salad, UPC 0 11596 14027 8, 16 oz, Product Code 4027. Marsh Signature Potato Salad, UPC 0 11596 51085 9, 2/5 lb. , Product Code 1085. Family Style Potato Salad, UPC 0 11596 51061 3, 2/5 lb., Product Code 1061. Grandpa's Potato Salad, UPC 0 11596 24227 9, 2 lb., Product Code 4227. Grandpa's Potato Salad, UPC 0 11596 34326 6, 3 lb., Product Code 4326. Grandpa's Potato Salad, UPC 0 11596 91026 0. , 2/5 lb., Product Code 1026. Spoon River Potato Salad, UPC 0 11596 51032 3, 2/5 lb., Product Code 1032. ","Code Date 4027 = 9/24/2013 - 10/9/2013. 1085.=10/9/2013 1061.=10/3/2013 - 10/9/2013 4227.=10/3/2013 - 10/9/2013 4326.=9/30/2013 - 10/10/2013 1026=. 9/30/2013 - 10/10/2013 1032.= 10/3/2013 - 10/10/2013 ",,"94,346 total cases, for all varieties","Garden-Fresh Foods is recalling various ready-to-eat salads, slaw, and dip products sold under various brands and codes because they may be contaminated with Listeria monocytogenes.",9/20/2013,"09/20/2013",12/18/2013,"12/18/2013"
"Food",66623,"Ongoing","Garden-Fresh Foods, Inc.","Milwaukee","WI","US","Voluntary: Firm Initiated","Letter","nationwide","F-0431-2014","Class I","Finest Traditions Homemade-Style Cole Slaw, UPC 7 33147 00025 0, 16 oz, Product Code 38858. ","Product Code 9/23/2013 - 10/10/2013",,"94,346 total cases, for all varieties","Garden-Fresh Foods is recalling various ready-to-eat salads, slaw, and dip products sold under various brands and codes because they may be contaminated with Listeria monocytogenes.",9/20/2013,"09/20/2013",12/18/2013,"12/18/2013"
"Food",66623,"Ongoing","Garden-Fresh Foods, Inc.","Milwaukee","WI","US","Voluntary: Firm Initiated","Letter","nationwide","F-0465-2014","Class I","Our Own Premium Potato Salad, UPC 0 11596 91045 1, 4/5 lb. , Product Code 1045. 9/28/2013-10/5/2013 ","Code Date 1045. = 9/28/2013-10/5/2013 ",,"94,346 total cases, for all varieties","Garden-Fresh Foods is recalling various ready-to-eat salads, slaw, and dip products sold under various brands and codes because they may be contaminated with Listeria monocytogenes.",9/20/2013,"09/20/2013",12/18/2013,"12/18/2013"
"Food",66623,"Ongoing","Garden-Fresh Foods, Inc.","Milwaukee","WI","US","Voluntary: Firm Initiated","Letter","nationwide","F-0451-2014","Class I","Dairy Fresh Homemade Dixie Cole Slaw, UPC 0 70163 55890 8, 2/5 lb., Product Code 405890. 9/30/2013 - 10/6/2013 ","Code Date . 405890. = 9/30/2013 - 10/6/2013 ",,"94,346 total cases, for all varieties","Garden-Fresh Foods is recalling various ready-to-eat salads, slaw, and dip products sold under various brands and codes because they may be contaminated with Listeria monocytogenes.",9/20/2013,"09/20/2013",12/18/2013,"12/18/2013"
"Devices",66624,"Ongoing","Terumo Cardiovascular Systems Corporation","Ann Arbor","MI","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution-USA including DC and the states of MO,TX,OK, LA, MA, CA, WI, and MI and the country of Canada.","Z-0196-2014","Class II","Sarns'' Venous Return Cannulae, 20 Fr with 1/4'' flare, 14.5'' (37 cm) long. Indicated for venous drainage during cardiopulmonary bypass surgery for dial cannulation of the superior and inferior vena cava.","Catalog Number 9473 Lot Numbers 0689812",".","40 units","During an in-process inspection, Terumo Cardiovascular Systems (Terumo CVS) identified the presence of loose fiber particulate that exceeded finished product specifications on certain product lots of Sarns'' Soft-Flow Aortic Cannulae and Sarns'' Venous Return Cannulae.",10/23/2013,"10/23/2013",11/20/2013,"11/20/2013"
"Devices",66624,"Ongoing","Terumo Cardiovascular Systems Corporation","Ann Arbor","MI","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution-USA including DC and the states of MO,TX,OK, LA, MA, CA, WI, and MI and the country of Canada.","Z-0193-2014","Class II","Sarns'' Soft-Flow Aortic Cannula without Suture Flange, angled tip, wire-reinforced with luer port, aortic cannula, 8.0 mm (24 Fr) OD with 3/8'' connector, 14'' (36 cm) long. Indicated for use in perfusion of the ascending aorta during cardiopulmonary bypass surgery.","Catalog Number 5762 Lot Numbers 0677300",".","90 units","During an in-process inspection, Terumo Cardiovascular Systems (Terumo CVS) identified the presence of loose fiber particulate that exceeded finished product specifications on certain product lots of Sarns'' Soft-Flow Aortic Cannulae and Sarns'' Venous Return Cannulae.",10/23/2013,"10/23/2013",11/20/2013,"11/20/2013"
"Devices",66624,"Ongoing","Terumo Cardiovascular Systems Corporation","Ann Arbor","MI","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution-USA including DC and the states of MO,TX,OK, LA, MA, CA, WI, and MI and the country of Canada.","Z-0195-2014","Class II","Sarns'' Soft-Flow Aortic Cannula without Suture Flange, straight tip, wire-reinforced with luer port, aortic cannula, 8.0 mm (24 Fr) OD with 3/8'' connector, 14'' (36 cm) long. Indicated for use in perfusion of the ascending aorta during cardiopulmonary bypass surgery.","Catalog Number 5841 Lot Numbers 0677302",".","30 units","During an in-process inspection, Terumo Cardiovascular Systems (Terumo CVS) identified the presence of loose fiber particulate that exceeded finished product specifications on certain product lots of Sarns'' Soft-Flow Aortic Cannulae and Sarns'' Venous Return Cannulae.",10/23/2013,"10/23/2013",11/20/2013,"11/20/2013"
"Devices",66624,"Ongoing","Terumo Cardiovascular Systems Corporation","Ann Arbor","MI","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution-USA including DC and the states of MO,TX,OK, LA, MA, CA, WI, and MI and the country of Canada.","Z-0194-2014","Class II","Sarns'' Soft-Flow Aortic Cannula without Suture Flange, straight tip, wire-reinforced with luer port, aortic cannula, 7.0 mm (21 Fr) OD with 3/8'' connector, 14'' (36 cm) long. Indicated for use in perfusion of the ascending aorta during cardiopulmonary bypass surgery.","Catalog Number 5798 Lot Numbers 0677301",".","70 units","During an in-process inspection, Terumo Cardiovascular Systems (Terumo CVS) identified the presence of loose fiber particulate that exceeded finished product specifications on certain product lots of Sarns'' Soft-Flow Aortic Cannulae and Sarns'' Venous Return Cannulae.",10/23/2013,"10/23/2013",11/20/2013,"11/20/2013"
"Devices",66626,"Ongoing","Microgenics Corp","Fremont","CA","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution - USA including WI, UT, ND, MT, WA, CA, OK and Internationally to Australia, Canada, and Germany.","Z-0513-2014","Class II","Thermo Fisher Scientific/Microgenics brand CEDIA Tobramycin II Assay, Catalog Number 100018, Product is manufactured and distributed by Microgenics Corporation, located at Fremont, CA., part of Thermo Fisher Scientific The CEDIA Tobramycin II Assay is an in vitro diagnostic medical device intended for the quantitation of Tobramycin in human serum or plasma.","Lot Number: 60169764",".","370 units","Microgenics Corp., part of Thermo Fisher Scientific, is recalling CEDIA Tobramycin II Assay (Lot Number: 60169764) due to calibration stability problem relating to two complaints received.",10/16/2013,"10/16/2013",12/26/2013,"12/26/2013"
"Devices",66627,"Ongoing","Ethicon, Inc.","Somerville","NJ","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution-USA (nationwide) and countries of: Caribbean, Chile, Singapore and Malaysia.","Z-0458-2014","Class II","Ethicon Stratafix Symmetric PDS Plus Knotless Tissue Control Device Ethicon LLC Guaynabo, Puerto Rico 00969. Intended for general soft tissue approximation where use of an absorbable suture is appropriate. ","K113004 D183642 All product codes beginning with SXPP1A.",,"37,164 eaches","Ethicon Stratafix Symmetric PDS Plus Knotless Tissue Control Device has a small number of tab failures and fascial dehiscences in lower abdominal incisions.",9/25/2013,"09/25/2013",12/18/2013,"12/18/2013"
"Food",66629,"Ongoing","N A Trading Inc","Los Angeles","CA","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","US states: KS, MN, HI, OH, CA, GA, NY, MO, OR, UT, TX, and Washington D.C.","F-0222-2014","Class II","CTF Brand Tapioca Pearl Pandan (Green Color), 14oz Plastic Bags, Packaged at 50 bags per case. Packaged in plastic heat-sealed pouch. Brand name is CTF with an illustration of a deer. Product labeling reads in part:''C.T.F. Brand TAPIOCA PEARL***EXPORTED: COMBINE THAI FOODS CO., LTD.***PRODUCT OF THAILAND NET WT:14OZ(400 G)***''","UPC Code 8 851381 561145. No Lot Codes or Best By Dates. The product only has a UPC code for the public's identification purposes. ",,"90 cases","The recall has been initiated due to missing ingredients not being shown in the ingredient list of the packaging. The missing ingredients are: Artificial Color Yellow No. 5 and Brilliant Blue FD&C No. 1.",10/24/2013,"10/24/2013",11/27/2013,"11/27/2013"
"Food",66630,"Ongoing","New Algae Company ","Klamath Falls","OR","US","Voluntary: Firm Initiated","Telephone","Distributed nationwide.","F-0216-2014","Class I","Flex, Maximum Flexibility, Item number 21-601, dietary supplement, 90 capsules per bottle. The Flex product is a dietary supplement in capsule form containing vegetable glucosamine HCL, chondroitin sulfate (shark cartilage), organic microalgae (aph. flos-aquae) and chicken cartilage. The serving size is 3 capsules and the suggested use is one 3 capsule serving per day. ","Lot EY1, manufacturing date of 8/2013. (product expires by August 2015)",,"103 bottles (90 capsules per bottle)","Flex dietary supplement product is recalled because the finished label does not declare shark cartilage.",10/23/2013,"10/23/2013",11/27/2013,"11/27/2013"
"Food",66630,"Ongoing","New Algae Company ","Klamath Falls","OR","US","Voluntary: Firm Initiated","Telephone","Distributed nationwide.","F-0215-2014","Class I","EDGE, Item number 21-620, dietary supplement, 60 packet per box. The Edge product includes two different packets of capsules - a ''Before'' packet and an ''After'' packet. The suggested use for the After packet is one packet (or 6 capsules) per day. The suggested use for the ''Before'' packet is one packet (or 4 capsules) per day. ","Lot BO1 and AO1, Expiration date Aug 2015",,"310 boxes (60 packets per box)","EDGE dietary supplement product is recalled because the finished label does not declare shark cartilage.",10/23/2013,"10/23/2013",11/27/2013,"11/27/2013"
"Devices",66631,"Ongoing","GE Healthcare, LLC","Waukesha","WI","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution - USA (nationwide) including the states of AL, AZ, CA, CO, CT, DE, FL, GA, HI, ID, IL, IN, IA, KS, KY, LA, MI, ME, MD, MA, MN, MS,MO,MT, NV, NH, NJ, NY, NC, OH, OK, PA, PR, SC, SD, TN, TX, UT, VA, WV and WI., and the countries of ALGERIA, AUSTRALIA, BELGIUM, BRAZIL, BULGARIA, CANADA, CHINA, COLOMBIA, DENMARK, EGYPT, ESTONIA, FINLAND, FRANCE, GERMANY, GREECE, GUADELOUPE, HONG KONG, INDIA, IRELAND, ISRAEL, ITALY,. JAPAN, REPUBLIC OF KOREA, KUWAIT, MEXICO, NETHERLANDS, NEW ZEAL NAD, NORWAY, PAKISTAN, POLAND,QUATAR, RUSSIA, SAUDI ARABIA, SINGAPORE, SOUTH AFRICA, SPAIN, SWEDEN, SWITZERLAND, TAIWAN,K THAILAND, TURKEY and UNITED KINGDOM.","Z-0367-2014","Class II","GE Healthcare Discovery NMCT 670, Discovery NM 630, Optima NMCT 640, & Brivo NM 615. The GE Discovery NMJCT 670 system is a medical tool intended for use by appropriately trained healthcare professionals to aid in detecting, localizing, diagnosing of diseases and organ function for the evaluation of diseases, trauma, abnormalities, and disorders such as, but not limited to, cardiovascular disease, neurological disorders and cancer. The system output can also be used by the physician for staging and restaging of tumors, planning, guiding, and monitoring therapy. The GE Discovery NM/CT 670 system, combining Nuclear Medicine (NM) and Computed Tomography (CT) systems, is intended to produce: NM System: General Nuclear Medicine imaging procedures for detection of radioisotope tracer uptake in the patient body, using a variety of scanning modes supported by various acquisition types and imaging features designed to enhance image quality. The scanning modes include planar mode (Static, Multi-gated, Dynamic and Whole body scanning) and tomographic mode (SPECT, Gated SPECT, Whole body SPECT). The acquisition types include single and multi-isotope/multi peak frame/list mode single-photon imaging. The imaging-enhancement features include assortment of collimators, gating by physiological signals, and real-time automatic body contouring. CT System: Cross sectional images of the body by computer reconstruction of X-Ray transmission data taken at different angles and planes, including Axial, Cine, Helical, Cardiac, and Gated acquisitions. These images may be obtained with or without contrast. The CT system is indicated for head, whole body, cardiac and vascular X-Ray Computed Tomography applications NM + CT System: Combined, hybrid SPECT and CT protocols, for CT-based SPECT attenuation corrected imaging as well as functional and anatomical mapping imaging (localization, registration and fusion). The GE Discovery NM/CT 670 system may include signal analysis and display equipment, patient and equipment supports, components ","Serial # System ID 21000 262574D670 21023 309671SPECT 21030 856247NM 21032 617638DSV670 21044 404686NMCT 21045 972935D670 21054 262574D630 21062 305674D670 21065 PITT670 21069 212639NMD670 21074 423495D670 21078 615322NM5 21105 803751D670 21111 DUKECCDSV670NM 21114 614NCH670 21117 262574O640 21127 410D6701 21149 540332D670 21157 856247D670 21172 630432D670 21182 GON1409671 21188 415353D670 21189 DUKEDMP670NM 21193 610402D670NM1 21201 720848D670 21202 972747NM670 21221 410955D670 21223 307362D670 21224 660890D670 22002 619474D630 22004 618443DISC1 22007 814623D630 22010 251639D630 22012 704355D630 22013 956523D630 22017 845454D630 22018 618842DISC1 22024 601354D630 22025 773282D630 22026 813558D630 22027 941LWRNM630 22029 PRINCE630 22030 281540D630 22032 417781D630 22033 601288D630 22034 913345D630 22036 318798D630 22039 614NCH630 22040 904321DSC1 22041 317887D630 22042 318448D630 22043 JHDSV630NM 22045 217544PH630 22046 301877D630 22047 601798D630 22048 716372NM630 22049 580531NM630 22050 651DSC630 22052 205333D630 22053 618942NM630 22054 813615D630 22055 719587D630 22056 903GSD630 22057 417533D630 22058 708684D630 22059 937SNHC630 22060 GON1399460 22061 GON1399458 22062 GON1399459 22063 GON2996508 22064 918502DIS1 22065 804675D630A 22066 469814NM630 22067 978354DSV630 22068 585922NM630 22069 305596D630A 22070 GON4029581 22072 POIN630 22076 GON1406902 22077 816234D630 22081 808485NM630 22082 989227D630 22085 305596D630B 22087 801714D630 22088 815564D630 22090 GON1413295 22091 702388VNM2 22092 760778D630 22094 269945D630 22095 843347D630 22096 201418D630 22097 319364D630B 22098 207664NM630 22099 334287NM630 22101 609978D630 22103 843797TD630 22105 319364D630A 22112 OSC630 22117 330386D630 22119 909599D630 22122 904276DSC1 22123 270417D630 22124 901226D630 22125 208455NM630 22126 409212NM630 22127 770751D630 22131 DMP630A 22132 936NMD630 22134 856355D630 22135 DMP630B 22136 605322D630 22137 775STMANM630A 22138 951303D630 22139 850862D630 22141 765447D630 22143 203384D630 22144 WH231NM630 22145 603354NM630 22148 ",,"464 (143 US, 321 OUS)","GE Healthcare has recently become aware of a potential safety issue related to a SPECT scan procedure used for pulmonary imaging. Contact between the Detector (GE Healthcare Discovery NM/CT 670, and/or Optima NM/CT 640, and/or Discovery NM630, and/or Brivo NM 615 all configurations) and the Patient's elbow may occur during SPECT protocols using 450 angular steps in scenarios when a Patients arms are positioned above the head and when dedicated safety armbands are not utilized.",10/25/2013,"10/25/2013",11/27/2013,"11/27/2013"
"Devices",66632,"Ongoing","Cincinnati Sub-Zero Products Inc","Cincinnati","OH","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution - US Distribution including the following states AK, CO, FL, MA, MI, and NC. and Internationally to Canada, Germany and United Kingdom.","Z-0443-2014","Class II","Blanketrol III Data Export Software Version 1.10 The Blanketrol III Data Export Software is intended for use in the electronic transfer of medical device data from the Blanketrol III to a computer, without controlling or altering the function or parameters of the Blanketrol III.","Product/Part #86127, Catalog #USB-127, Lot #00554",".","12 Units","During a customer inquiry regarding a beta version of the Bill Data Export Software, Model USB-127, it was discovered that the wrong software version was released to a customer.",5/15/2013,"05/15/2013",12/11/2013,"12/11/2013"
"Food",66633,"Ongoing","The Sweetwater Co., Inc.","Culver","OR","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","distributed in CA and OR.","F-0723-2014","Class II","Refreshe Mixed Berry Naturally Flavored Electrolyte Water, 12 bottles per cases, 1 L per bottle, sold under Safeway brand. The UPC 0 21130 24209 2.","Best by date 10/11/2014. S3805 0700 through 1500. S3805 - is the firm's customer information. Number 0700 through 1500 is the time the bottle was produced from 07:00 hours to 15:00 hours.",".","748 cases","Sweetwater Company recalls Refreshe Mixed Berry Naturally Flavored Electrolyte Water (1 L size) due to elevated amount of non-fecal total Coliforms.",10/24/2013,"10/24/2013",12/11/2013,"12/11/2013"
"Food",66633,"Ongoing","The Sweetwater Co., Inc.","Culver","OR","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","distributed in CA and OR.","F-0722-2014","Class II","Refreshe Lime Naturally Flavored Electrolyte Water, 12 bottles per cases, 1 L per bottle, sold under Safeway brand. The UPC 0 21130 24208 5.","Best by date 10/11/2014. S3805 0700 through 1500. S3805 - is the firm's customer information. Number 0700 through 1500 is the time the bottle was produced from 07:00 hours to 15:00 hours.",".","680 cases","Sweetwater Company recalls Refreshe Lime Naturally Flavored Electrolyte Water (1 L size) due to elevated amount of non-fecal total Coliforms.",10/24/2013,"10/24/2013",12/11/2013,"12/11/2013"
"Food",66634,"Terminated","Torn Ranch Inc.","Petaluma","CA","US","Voluntary: Firm Initiated","Letter","US only - CA, TX, FL, MS, WA, NC, MA, IN, NC, NY, PA.","F-0173-2014","Class II","Fruit Truffles - Cherry, Coconut, Key Lime, Lemon, Mango, Pear, Pineapple and Tangelo flavors. (6 piece count/4.5 oz) Pear, Lemon, Key Lime, Coconut flavors contain FD&C Y5 and/or Y6; (9 piece count/7 oz) Pear, Cherry, Tangelo, Coconut, Lemon, Key Lime flavors contain FD&C Y5 and/or Y6 ; (12 piece count/9 oz) Mango, Pineapple, Tangelo, Cherry, Pear, Coconut, Key Lime, Lemon flavors contain FD&C Y5 and/or Y6; Firm also sells 2 piece count/1.5 oz products. However, this product only contains 2 strawberry flavors and do not contain FD&C Y5 and/or Y6. Sold to the hospitality industry. Product of the USA. Manufactured by Torn Ranch, Petaluma, CA 94954","(6 piece count/4.5 oz) = ITEM CODE S307-H (9 piece count/7 oz) = ITEM CODE S308-H (12 piece count/9 oz) = ITEM CODE S309-H Lot numbers: 1453-2963 Best By Date: October 24, 2013-February 23, 2014 (Best by date is 4 months after manufacturing date of product) ",".","3840 individual truffles","FDA inspection at the firm found that Yellow # 5 and 6 used in decoration on top of fruit truffles was not declared in the ingredient statement.",10/25/2013,"10/25/2013",11/20/2013,"11/20/2013"
"Devices",66635,"Ongoing","Carl Zeiss Meditec, Inc.","Dublin","CA","US","Voluntary: Firm Initiated","Letter","Nationwide distribution.","Z-0334-2014","Class II","Zeiss brand IOLMaster 500, Model 500, Biomicroscope, Slit-Lamp, AC-Powered, Product is manufactured by Carl Zeiss Meditec AG (Jena), Carl Zeiss Promenade 10, Jena, Germany 07745; and distributed by Carl Zeiss Meditec, Inc., Dublin, CA This device is intended for use primarily by physicians and health care workers and may be only used under the supervision of a physician. This device will not be sold to the general public. The IOLMaster is intended for the biometric determination of ocular measurements of axial length, anterior chamber depth, corneal radius, white-to white (WTW), and for the measurement of pupil size and deviation of the visual axis from the center of the pupil. For patients who are candidates for intraocular lens (IOL) implantation, the device also performs calculations to assist physicians in determining the appropriate IOL power and type for implantation","Serial Numbers: 817123 1038929 1038930 1044483 1044485 1044487 1044488 1044489 1044490 1045639 1046055 1046056 1046057 1046343 1046344 1046345 1046353 1046355 1046364 1046373 1046374 1046376 1046377 1046378 1046380 1046381 1046488 1046489 1046500 1046509 1046514 1046516 1046523 1047089 1047090 1047091 1047092 1047093 1047101 1047107 1047111 1047266 1047267 1047268 1047269 1047270 1047271 1047272 1047273 1047275 1047279 1047282 1047283 1047284 1047485 1047486 1047494 1047498 1047499 1047507 1047512 1047513 1047518 1047519 1047520 1047521 1047522 1047523 1047524 1047914 1047921 1047922 1047923 1047924 1047933 1047934 1047935 1047936 1047938 1048579 1048580 1048581 1048582 1048583 1048584 1048585 1048587 1048589 1049601 1049602 1049603 1049604 1049605 1049607 1049608 1049609 1049610 1049611 1049620 1049621 1049622 1050560 1050561 1050562 1050563 1050564 1050566 1050567 1050568 1050569 1050748 1050749 1050751 1050752 1050753 1050754 1050755 1050756 1050757 1050758 1050759 1050760 1050761 1050762 1050763 1051518 1051519 1051520 1051521 1051522 1051523 1051524 1051525 1051526 1051527 1051528 1051529 1051530 1051531 1051533 1051534 1051536 1051538 1051550 1051551 1051552 1051553 1051554 1051860 1051861 1051872 1051873 1051874 1051875 1051876 1051877 1051879 1052512 1052513 1052515 1052516 1052517 1052518 1052519 1052520 1052527 1052528 1052529 1052917 1052918 1052919 1052920 1052944 1052945 1052946 1052947 1052948 1052949 1052951 1052952 1052955 1053181 1053183 1053186 1053187 1053188 1053189 1053190 1053191 1053193 1053194 1053206 1053207 1053208 1053209 1053210 1053211 1053212 1053213 1053554 1053555 1053556 1053558 1053561 1053562 1053563 1053564 1053566 1053567 1053568 1053571 1053573 1053574 1053841 1053847 1054330 1054332 1054338 1054339 1054341 1054342 1054343 1054344 1054347 1054351 1054360 1054362 1054363 1054365 1054366 1054367 1054369 1055236 1055244 1055245 1055246 1055247 1055248 1055249 1055251 1055263 1055266 1055267 1055268 1055949 1055950 1055951 1055952 1055953 1055954 1056018 1056019 1056020 105602",,"1,201 units","The user database delivered for download contained an erroneous value. Specifically the ''aO'' constant of the lens AMO Sensar AR40E is listed as ''0.0'' in the internal lens database of the IOLMaster. The correct value is -2.420. This could lead to the implantation of lens with a wrong diopter value.",10/23/2013,"10/23/2013",11/27/2013,"11/27/2013"
"Devices",66635,"Ongoing","Carl Zeiss Meditec, Inc.","Dublin","CA","US","Voluntary: Firm Initiated","Letter","Nationwide distribution.","Z-0333-2014","Class II","Zeiss brand IOLMaster, Version 1-5, Biomicroscope, Slit-Lamp, AC-Powered, Product is manufactured by Carl Zeiss Meditec AG (Jena), Carl Zeiss Promenade 10, Jena, Germany 07745; and distributed by Carl Zeiss Meditec, Inc., Dublin, CA This device is intended for use primarily by physicians and health care workers and may be only used under the supervision of a physician. This device will not be sold to the general public. The IOLMaster is intended for the biometric determination of ocular measurements of axial length, anterior chamber depth, corneal radius, white-to white (WTW), and for the measurement of pupil size and deviation of the visual axis from the center of the pupil. For patients who are candidates for intraocular lens (IOL) implantation, the device also performs calculations to assist physicians in determining the appropriate IOL power and type for implantation","Serial Numbers: 128008 793173 793176 793179 793186 793196 797156 797185 797236 798364 798365 798366 798370 798373 798376 798413 798414 798416 798417 798426 798429 798440 798442 798444 798452 798454 798757 798759 798761 798763 798764 798765 798768 801922 801923 801924 801927 801928 801931 801934 801937 801939 801942 801943 801944 801945 801947 801949 801952 801953 801954 801955 801958 801959 801960 801961 801962 801963 801964 801965 801972 801973 801974 801975 801978 801979 801980 801981 801983 801984 801995 801996 801997 801998 801999 802001 802002 802003 802004 802006 802007 802008 802009 802010 802011 802012 802013 802014 802015 802016 802017 804234 806022 806025 806028 806029 806031 806032 806033 806034 806036 806037 806038 806039 806041 806042 806053 806056 806058 806059 806060 806061 806062 806063 806066 806067 806068 806069 806071 806073 806074. 806075 806077 806078 806080 806082 806084 806086 806087 806088 806089 806090 806092 806094 806095 806097 806099 806100 806101 806103 806106 806107 806108 806109 806110 806111 806112 806113 806116 806122 806124 806125 806126 806127 806131 806133 806134 806135 806137 806139 806141 806143 806144 806147 806149 806150 806151 806153 806154 806155 806159 806160 806162 806164 806165 806166 806169 806170 806171 806172 806174 806175 806178 806180 806181 806183 806184 806186 806189 806191 806192 806193 806194 806195 806196 806199 806204 806205 806208 806209 806210 806211 806213 806216 806218 806219 807147 807149 807151 807152 807153 807154 807156 807157 807158 807160 807163 807165 807168 807169 807170 807172 807174 807175 807176 807178 807180 807181 807182 807183 807184 807185 807187 807191 807195 807198 807200 807201 807203 807204 807205 807209 807210 807212 807216 807218 807220 807221 807222 807223 807224 807226 807228 807229 807230 807232 807233 807234 807235 807240 807241 807242 807243 807246 807247 807248 807249 807251 807253 807254 807256 807257 807258 807260 807262 807263 807264 807265 807266 807267 807268 807271 807274 807275 807277 807278 807282 807284 807287 80728"," 1045450 1045451 1045452 1045453 1045456 1045457 1045460 1045461 1045462 1045463 1045466 1045467 1045468 1045887 1045888 1045889 1045890 1064585 1094047 9000432 10002380 81500826 81500986 81500992","4,907 units","The user database delivered for download contained an erroneous value. Specifically the ''aO'' constant of the lens AMO Sensar AR40E is listed as ''0.0'' in the internal lens database of the IOLMaster. The correct value is -2.420. This could lead to the implantation of lens with a wrong diopter value.",10/23/2013,"10/23/2013",11/27/2013,"11/27/2013"
"Drugs",66637,"Ongoing","Hospira Inc.","Lake Forest","IL","US","Voluntary: Firm Initiated","Letter","Nationwide","D-66637-001","Class II","Propofol Injectable Emulsion, 1%, 200 mg/20 mL (10 mg/mL), 20 mL single patient infusion vial packaged in 5 Units x 20 mL per carton, Rx Only, Hospira, Inc., Lake Forest, IL 60045, NDC 0409-4699-30.","Lot #: 27-570-DJ, Exp 03/01/15",".","70,450 vials","Presence of Particulate Matter: Visible particles embedded in the glass identified during a retain sample inspection.",10/11/2013,"10/11/2013",11/13/2013,"11/13/2013"
"Devices",66638,"Ongoing","GE Healthcare, LLC","Waukesha","WI","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution - USA (nationwide) Puerto Rico and Internationally to Canada, Costa Rica, Mexico, and Venezuela.","Z-0472-2014","Class I","Multi Absorber Original, Disposable M1173310 Multi Absorber Original, Disposable, package of 6 pcs, GE Healthcare Finland Oy Kuortaneenkatu 2 FI-00510 Helsinki, Finland +358 10 394 11 Made in US Rx Only The GE Healthcare Multi Absorber Original, Disposable is a disposable product intended for use with the GE Healthcare Advanced Breathing System (later ABS), the GE Healthcare EZchange manifold, the GE Healthcare Compact Block, and the GE Healthcare Compact Block II (later Compact Block). The Multi Absorber should only be used with air, oxygen, nitrous oxide, halothane, enflurane, isoflurane, desflurane and sevoflurane. The device is intended to be used under constant attention of qualified professional healthcare personnel.","Product number M1173310 containing lot numbers 12001 through 13031.",".","US: 59,721 boxes, 358,326 canisters; OUS: 3,724 boxes, 22,344 canisters","GE Healthcare has recently become aware of a potential safety issue due to air leakage associated with the CO2 Multi Absorber. ",9/19/2013,"09/19/2013",12/26/2013,"12/26/2013"
"Devices",66639,"Ongoing","Biomet, Inc.","Warsaw","IN","US","Voluntary: Firm Initiated","Letter","USA Nationwide Distribution in the states of VA, CA, Ky, and IN","Z-0364-2014","Class II","Juggerknotless Drill Bit, REF 110003173, Sterile, Single Use Product Usage: The Juggerknotless Soft Anchors are indicated for soft tissue reattachment procedures in the shoulder, foot/ankle, hand/wrist, and hip. ","Catalog:110003173, Lot 127480, 185420, 233500, 233520",,"25","Investigation identified that the design of the drill bit may make the suture anchor difficult to insert into the bone. The implant may skip across the hole or miss the hole during insertion. ",10/10/2013,"10/10/2013",11/27/2013,"11/27/2013"
"Devices",66640,"Ongoing","Teleflex Medical","Durham","NC","US","Voluntary: Firm Initiated","Letter","Nationwide distribution: AL, AZ, CA, CO, FL, GA, IL, IN, IA, KY, LA, MD, MA, MI, MN, MO, NE, NJ, NM, NY, NC, OH, OK, OR, PA, SC, TN, TX, VA, WA, WV and WI.","Z-0366-2014","Class II","Green Rusch - Lite Disposable Metal Laryngoscope Ridge Blade to visualize upper airway and aid in placement of tracheal tube.","Product Code 004551004; Lot 1305342",,"6,200 ea. ","Labeling inconsistency",10/15/2013,"10/15/2013",11/27/2013,"11/27/2013"
"Biologics",66641,"Terminated","Southern California Permanente Medical Group Blood Donor Ctr","Downey","CA","US","Voluntary: Firm Initiated","Telephone","CA","B-0160-14","Class II","Red Blood Cells","W071813011695",".","1 unit","Blood product, which did not meet the acceptable product specifications, was distributed.",9/16/2013,"09/16/2013",12/26/2013,"12/26/2013"
"Biologics",66642,"Terminated","Community Blood Center, Inc.","Appleton","WI","US","Voluntary: Firm Initiated","Letter","WI","B-0163-14","Class II","Red Blood Cells Leukocytes Reduced Irradiated","W053313504190",".","1 unit","Blood product, collected from a donor who traveled to a malarial endemic area, was distributed. ",9/16/2013,"09/16/2013",12/26/2013,"12/26/2013"
"Biologics",66643,"Terminated","American National Red Cross","Columbus","OH","US","Voluntary: Firm Initiated","Telephone","MI, OH","B-0251-14","Class III","Red Blood Cells Leukocytes Reduced","W201613002140; W201613002141; W201613002143; W201613002148; W201613002151; W201613002154; W201613002627; W201613002629; W201613002631; W201613002633; W201613002636",".","11 units","Blood products, in which leukoreduced filtering was conducted beyond the allowable time limits, were distributed.",9/1/2013,"09/01/2013",12/26/2013,"12/26/2013"
"Biologics",66644,"Terminated","Blood Systems, Inc","Albuquerque","NM","US","Voluntary: Firm Initiated","Telephone","NM","B-0162-14","Class II","Plasma Frozen","W041212054451Z; W041213005013L ",".","2 units","Blood products, collected from a donor whose suitability to donate was not adequately determined, were distributed.",8/23/2012,"08/23/2012",12/26/2013,"12/26/2013"
"Biologics",66645,"Terminated","OneBlood, Inc.","St Petersburg","FL","US","Voluntary: Firm Initiated","FAX","FL","B-0161-14","Class II","Red Blood Cells Leukocytes Reduced","W039413463587",".","1 unit","Blood product, in which viral testing sample was exposed to unacceptable temperatures during storage, was distributed.",10/7/2013,"10/07/2013",12/26/2013,"12/26/2013"
"Biologics",66646,"Terminated","OneBlood, Inc.","St Petersburg","FL","US","Voluntary: Firm Initiated","FAX","Florida","B-0211-14","Class II","Platelets Pheresis Leukocytes Reduced","W03941345371800 (2 units)",".","2 units","Blood products, which were labeled as leukoreduced, but exceeded the acceptable limit for white blood cell count, were distributed.",10/4/2013,"10/04/2013",12/26/2013,"12/26/2013"
"Biologics",66647,"Terminated","OneBlood, Inc.","Hialeah","FL","US","Voluntary: Firm Initiated","Letter","Florida","B-0208-14","Class III","Recovered Plasma","W036812578156",".","1 unit","Blood products, collected from a donor for whom donor suitability was not adequately determined, were distributed.",9/10/2013,"09/10/2013",12/26/2013,"12/26/2013"
"Biologics",66647,"Terminated","OneBlood, Inc.","Hialeah","FL","US","Voluntary: Firm Initiated","Letter","Florida","B-0209-14","Class II","Red Blood Cells","W036812578156",".","1 unit","Blood products, collected from a donor for whom donor suitability was not adequately determined, were distributed.",9/10/2013,"09/10/2013",12/26/2013,"12/26/2013"
"Biologics",66648,"Terminated","OneBlood, Inc.","Hialeah","FL","US","Voluntary: Firm Initiated","Letter","Florida, New York","B-0205-14","Class II","Red Blood Cells Frozen Leukocytes Reduced Irradiated","1713729",".","1 unit","Blood products, collected from a donor for whom donor suitability was not adequately determined, were distributed.",9/6/2013,"09/06/2013",12/26/2013,"12/26/2013"
"Biologics",66648,"Terminated","OneBlood, Inc.","Hialeah","FL","US","Voluntary: Firm Initiated","Letter","Florida, New York","B-0206-14","Class II","Fresh Frozen Plasma","2009001, 2055840, 1643307",".","3 units","Blood products, collected from a donor for whom donor suitability was not adequately determined, were distributed.",9/6/2013,"09/06/2013",12/26/2013,"12/26/2013"
"Biologics",66648,"Terminated","OneBlood, Inc.","Hialeah","FL","US","Voluntary: Firm Initiated","Letter","Florida, New York","B-0202-14","Class II","Plasma Frozen within 24 hours (FP24)","2486226",".","1 unit","Blood products, collected from a donor for whom donor suitability was not adequately determined, were distributed.",9/6/2013,"09/06/2013",12/26/2013,"12/26/2013"
"Biologics",66648,"Terminated","OneBlood, Inc.","Hialeah","FL","US","Voluntary: Firm Initiated","Letter","Florida, New York","B-0204-14","Class II","Red Blood Cells","2486226, 2009001, 2055840, 1713729",".","4 units","Blood products, collected from a donor for whom donor suitability was not adequately determined, were distributed.",9/6/2013,"09/06/2013",12/26/2013,"12/26/2013"
"Biologics",66648,"Terminated","OneBlood, Inc.","Hialeah","FL","US","Voluntary: Firm Initiated","Letter","Florida, New York","B-0203-14","Class II","Red Blood Cells (Apheresis) Leukocytes Reduced","W036809229514 (2 units), 2234679 (2 units)",".","4 units","Blood products, collected from a donor for whom donor suitability was not adequately determined, were distributed.",9/6/2013,"09/06/2013",12/26/2013,"12/26/2013"
"Biologics",66648,"Terminated","OneBlood, Inc.","Hialeah","FL","US","Voluntary: Firm Initiated","Letter","Florida, New York","B-0207-14","Class II","Red Blood Cells Frozen Leukocytes Reduced","1643307",".","1 unit","Blood products, collected from a donor for whom donor suitability was not adequately determined, were distributed.",9/6/2013,"09/06/2013",12/26/2013,"12/26/2013"
"Biologics",66649,"Terminated","OneBlood, Inc.","Hialeah","FL","US","Voluntary: Firm Initiated","Letter","Switzerland, Florida","B-0201-14","Class III","Recovered Plasma","W036809346147",".","1 unit","Blood products, collected from a donor for whom donor suitability was not adequately determined, were distributed.",9/4/2013,"09/04/2013",12/26/2013,"12/26/2013"
"Biologics",66649,"Terminated","OneBlood, Inc.","Hialeah","FL","US","Voluntary: Firm Initiated","Letter","Switzerland, Florida","B-0200-14","Class II","Platelets Pooled Leukocytes Reduced","W036809824342",".","1 unit","Blood products, collected from a donor for whom donor suitability was not adequately determined, were distributed.",9/4/2013,"09/04/2013",12/26/2013,"12/26/2013"
"Biologics",66649,"Terminated","OneBlood, Inc.","Hialeah","FL","US","Voluntary: Firm Initiated","Letter","Switzerland, Florida","B-0199-14","Class II","Red Blood Cells","W036809346147",".","1 unit","Blood products, collected from a donor for whom donor suitability was not adequately determined, were distributed.",9/4/2013,"09/04/2013",12/26/2013,"12/26/2013"
"Biologics",66650,"Terminated","OneBlood / dba CBCF","Lauderhill","FL","US","Voluntary: Firm Initiated","Letter","Florida","B-0195-14","Class II","Red Blood Cells","2055363",,"1 unit","Blood product, collected from a donor for whom donor suitability was not adequately determined, was distributed.",9/4/2013,"09/04/2013",12/18/2013,"12/18/2013"
"Biologics",66652,"Terminated","OneBlood / dba CBCF","Lauderhill","FL","US","Voluntary: Firm Initiated","Letter","Florida","B-0193-14","Class II","Platelets","2199067",,"1 unit","Blood products, collected from a donor for whom donor suitability was not adequately determined, were distributed.",9/4/2013,"09/04/2013",12/18/2013,"12/18/2013"
"Biologics",66652,"Terminated","OneBlood / dba CBCF","Lauderhill","FL","US","Voluntary: Firm Initiated","Letter","Florida","B-0191-14","Class II","Red Blood Cells","2199067",,"1 unit","Blood products, collected from a donor for whom donor suitability was not adequately determined, were distributed.",9/4/2013,"09/04/2013",12/18/2013,"12/18/2013"
"Biologics",66652,"Terminated","OneBlood / dba CBCF","Lauderhill","FL","US","Voluntary: Firm Initiated","Letter","Florida","B-0192-14","Class II","Fresh Frozen Plasma","2199067",,"1 unit","Blood products, collected from a donor for whom donor suitability was not adequately determined, were distributed.",9/4/2013,"09/04/2013",12/18/2013,"12/18/2013"
"Biologics",66652,"Terminated","OneBlood / dba CBCF","Lauderhill","FL","US","Voluntary: Firm Initiated","Letter","Florida","B-0194-14","Class II","Red Blood Cells (Apheresis) Leukocytes Reduced","2482690 (2 units), 2124835 (2 units)",,"4 units","Blood products, collected from a donor for whom donor suitability was not adequately determined, were distributed.",9/4/2013,"09/04/2013",12/18/2013,"12/18/2013"
"Biologics",66653,"Terminated","OneBlood, Inc.","Hialeah","FL","US","Voluntary: Firm Initiated","Letter","Florida, New York","B-0189-14","Class II","Red Blood Cells","2240024, 2279914",,"2 units","Blood products, collected from a donor for whom donor suitability was not adequately determined, were distributed.",9/17/2013,"09/17/2013",12/18/2013,"12/18/2013"
"Biologics",66653,"Terminated","OneBlood, Inc.","Hialeah","FL","US","Voluntary: Firm Initiated","Letter","Florida, New York","B-0190-14","Class II","Cryoprecipitated AHF","2279914",,"1 unit","Blood products collected from a donor for whom donor suitibility was not adequately determined were distributed.",9/17/2013,"09/17/2013",12/18/2013,"12/18/2013"
"Biologics",66653,"Terminated","OneBlood, Inc.","Hialeah","FL","US","Voluntary: Firm Initiated","Letter","Florida, New York","B-0188-14","Class II","Fresh Frozen Plasma","2240024",,"1 unit","Blood products, collected from a donor for whom donor suitability was not adequately determined, were distributed.",9/17/2013,"09/17/2013",12/18/2013,"12/18/2013"
"Devices",66654,"Ongoing","Ebi, Llc","Parsippany","NJ","US","Voluntary: Firm Initiated","Letter","US Distribution to CA","Z-0411-2014","Class II","Shortened Plug Driver; Low Volume Specialty Device; Qty:1; Rx Only; Non Sterile; Biomet Spine, Parsippany, NJ 07054 The Polaris Spinal Systems is a non-cervical spinal fixation device intended for immobilization and stabilization as an adjunct to fusion as a pedical screw fixation system, a posterior hook and sacral/iliac screw fixation system, or as an anterior or anterolateral fixation system. Pedicle screw fixation is limited to skeletal mature patients for use with autograft and/or allograft. The device is indicated for all the following indications:degenerative disc disease (defined as discogeneic back pain with degeneration of the disk confirmed by history and radiographic studies), spondylolisthesis, and or lordosis) tumor, stenosis, pseudoarthrosis, or failed previous fusion","Device listing # D090878 Catalog # LV00407 Lot #184090",".","2 units","Biomet received a complaint on 5/20/2013 reporting that the tip of the instrument sheared off during a removal case.",9/24/2013,"09/24/2013",12/4/2013,"12/04/2013"
"Biologics",66655,"Terminated","OneBlood, Inc.","Hialeah","FL","US","Voluntary: Firm Initiated","Letter","Florida","B-0186-14","Class II","Red Blood Cells","2758681",,"1 unit","Blood products, collected from a donor for whom donor suitability was not adequately determined, were distributed.",8/27/2013,"08/27/2013",12/18/2013,"12/18/2013"
"Biologics",66655,"Terminated","OneBlood, Inc.","Hialeah","FL","US","Voluntary: Firm Initiated","Letter","Florida","B-0187-14","Class II","Cryoprecipitated AHF","2758681",,"1 unit","Blood products, collected from a donor for whom donor suitability was not adequately determined, were distributed.",8/27/2013,"08/27/2013",12/18/2013,"12/18/2013"
"Biologics",66656,"Terminated","OneBlood, Inc.","Hialeah","FL","US","Voluntary: Firm Initiated","Letter","Florida","B-0229-14","Class II","Fresh Frozen Plasma","1567739",,"1 unit","Blood products, collected from a donor for whom donor suitability was not adequately determined, were distributed.",8/27/2013,"08/27/2013",12/18/2013,"12/18/2013"
"Biologics",66656,"Terminated","OneBlood, Inc.","Hialeah","FL","US","Voluntary: Firm Initiated","Letter","Florida","B-0228-14","Class II","Red Blood Cells","1567739",,"1 unit","Blood products, collected from a donor for whom donor suitability was not adequately determined, were distributed.",8/27/2013,"08/27/2013",12/18/2013,"12/18/2013"
"Devices",66657,"Ongoing","Stryker Spine","Allendale","NJ","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution - USA (nationwide) and Internationally to Argentina, Australia, Canada, Chile, France, Canada, Germany, Hong Kong, Ireland, Italy, Japan, Korea, Netherlands, New Zealand, Spain, Iraq, Egypt, and Turkey.","Z-0375-2014","Class II","Stryker 1) XIA Torque Wrench 2) XIA 3 Torque Wrench 3) XIA Elegance Short Torque Wrench Manufactured by: Stryker Spine SAS Z.I. Marticot -33610 -CESTAS -FRANCE +33 (0) 5.57.97.06.30 http://www.stryker.com Distributed in the USA by: Stryker Spine 2 Pearl Court Allendale, NJ 07401-1677 USA +1-201-760-8000 XIA 3 Spinal System- Intended for use in the noncervical spine. When used as an anterior/anterloateral and posterior, non cervical pedicle and on-pedicled fixation system, the XIA 3 Spinal system is intended to provide additional support during fusion autograft or allograft in skeletally mature patients in the treatment of the following acute and chronic instabilities or deformities; degenerate disc disease (DDD) ; spondylolisthesis; trauma spinal stenosis; curvatures; tumor; pseudoarthrosis and failed previous fusion. XIA - Intended for anterior/anterolateral and posterior, non cervical pedicle and non-pedicle fixation of the spine to provide immobilization and stabilization of spinal segments in skeletally mature patients as an adjunct to fusion for the following indications: degenerative disc disease; spondylolisthesis, trauma, spinal stenosis, curvatures, tumor, pseudoarthrosis and failed previous fusion.","Medical Device Listing Number E207315 1) XIA Torque Wrench Catalog # 03807028 Lot # 127510 2) XIA 3 Torque Wrench Catalog # 48237028 Lot # 11E042, 11E044, 11E047 3) XIA Elegance Short Torque Wrench Catalog # 482397028 Lot # 11A957, 11E035, 11E036, R11E036",,"35 units US; 109 units OUS","Multiple complaints have reported that the hex tip of the torque wrench fracturing during final tightening.",9/24/2013,"09/24/2013",11/27/2013,"11/27/2013"
"Food",66658,"Ongoing","National Enzyme Co","Forsyth","MO","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Domestic distribution of the product is nationwide with direct accounts in 27 states in all geographical regions. Foreign distribution consists of direct accounts in the following countries: Canada, China, Malaysia, Norway, Slovakia, South Korea, Sweden, Taiwan, and the United Kingdom.","F-0790-2014","Class II","Dietary Supplement Formula ID B859; Packaged in the following configuration: B859 Kirkman Enz Comp DPP-IV, packaged in unlabeled, 90-count bottles (SKU 54112);","Lot #: 54112001",,"1155 bottles","Firm is recalling dietary supplements containing a raw material which may contain >0.3 ppb chloramphenicol",10/30/2013,"10/30/2013",12/18/2013,"12/18/2013"
"Food",66658,"Ongoing","National Enzyme Co","Forsyth","MO","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Domestic distribution of the product is nationwide with direct accounts in 27 states in all geographical regions. Foreign distribution consists of direct accounts in the following countries: Canada, China, Malaysia, Norway, Slovakia, South Korea, Sweden, Taiwan, and the United Kingdom.","F-0794-2014","Class II","IMTWellnes, Legume Digest 2.0, packaged 120-capsule bottles (SKU 54179). Firm name on the label is ANAT, LLC, Bloomfield, CT;","Lot #'s: 54179002, 54179003, and 54179004",,"2567 bottles","Firm is recalling dietary supplements containing a raw material which may contain >0.3 ppb chloramphenicol",10/30/2013,"10/30/2013",12/18/2013,"12/18/2013"
"Food",66658,"Ongoing","National Enzyme Co","Forsyth","MO","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Domestic distribution of the product is nationwide with direct accounts in 27 states in all geographical regions. Foreign distribution consists of direct accounts in the following countries: Canada, China, Malaysia, Norway, Slovakia, South Korea, Sweden, Taiwan, and the United Kingdom.","F-0770-2014","Class II","Bulk 9843 NOW Digest Platinum BLK capsules, packaged in poly bags in corrugated boxes (for domestic distribution) or fiber drums (for international distribution) (SKU 92101).","Lot #'s: 92101011, 92101013, and 92101014",,"3,847,856 bulk capsules","Firm is recalling dietary supplements containing a raw material which may contain >0.3 ppb chloramphenicol",10/30/2013,"10/30/2013",12/18/2013,"12/18/2013"
"Food",66658,"Ongoing","National Enzyme Co","Forsyth","MO","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Domestic distribution of the product is nationwide with direct accounts in 27 states in all geographical regions. Foreign distribution consists of direct accounts in the following countries: Canada, China, Malaysia, Norway, Slovakia, South Korea, Sweden, Taiwan, and the United Kingdom.","F-0775-2014","Class II","Bulk A164 NUTRACHOICE DIGESTIVEBL powder (SKU 83196), packaged in varying quantities within poly bags in corrugated boxes (for domestic distribution) or fiber drums (for international distribution)","Lot #'s: 83196007, 83196008, 83196009, and 83196011",,"258.3 kg of powder","Firm is recalling dietary supplements containing a raw material which may contain >0.3 ppb chloramphenicol",10/30/2013,"10/30/2013",12/18/2013,"12/18/2013"
"Food",66658,"Ongoing","National Enzyme Co","Forsyth","MO","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Domestic distribution of the product is nationwide with direct accounts in 27 states in all geographical regions. Foreign distribution consists of direct accounts in the following countries: Canada, China, Malaysia, Norway, Slovakia, South Korea, Sweden, Taiwan, and the United Kingdom.","F-0783-2014","Class II","Bulk A977 Wedar Digestive Blend 2 powder, packaged in varying quantities within poly bags within corrugated boxes (for domestic distribution) or fiber drums (for international distribution) (SKU 83314);","Lot #'s: 83314009, 83314010, 83314011, 83314012, 83314013, 83314014, 83314015, 83314016, 83314017, 83314018, 83314019, 83314020, 83314021, 83314022, 83314023, and 83314024",,"1850.68 kg of powder","Firm is recalling dietary supplements containing a raw material which may contain >0.3 ppb chloramphenicol",10/30/2013,"10/30/2013",12/18/2013,"12/18/2013"
"Food",66658,"Ongoing","National Enzyme Co","Forsyth","MO","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Domestic distribution of the product is nationwide with direct accounts in 27 states in all geographical regions. Foreign distribution consists of direct accounts in the following countries: Canada, China, Malaysia, Norway, Slovakia, South Korea, Sweden, Taiwan, and the United Kingdom.","F-0795-2014","Class II","IMTWellnes, Tribulus Supreme 2.0, GI & Immune Support, packaged 60-capsule bottles (SKU 54217). Firm name on the label is ANAT, LLC, Bloomfield, CT;","Lot #: 54217002",,"1807 bottles","Firm is recalling dietary supplements containing a raw material which may contain >0.3 ppb chloramphenicol",10/30/2013,"10/30/2013",12/18/2013,"12/18/2013"
"Food",66658,"Ongoing","National Enzyme Co","Forsyth","MO","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Domestic distribution of the product is nationwide with direct accounts in 27 states in all geographical regions. Foreign distribution consists of direct accounts in the following countries: Canada, China, Malaysia, Norway, Slovakia, South Korea, Sweden, Taiwan, and the United Kingdom.","F-0736-2014","Class II","ProSol Professional Solutions Fiber Digestion Enzyme Supplement, packaged in 90-(SKU 51855) capsule bottles. The firm name on the label is Enzymes, Inc., Kansas City, MO ","Lot#: 51855019",,"617 Bottles","Firm is recalling dietary supplements containing a raw material which may contain >0.3 ppb chloramphenicol",10/30/2013,"10/30/2013",12/18/2013,"12/18/2013"
"Food",66658,"Ongoing","National Enzyme Co","Forsyth","MO","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Domestic distribution of the product is nationwide with direct accounts in 27 states in all geographical regions. Foreign distribution consists of direct accounts in the following countries: Canada, China, Malaysia, Norway, Slovakia, South Korea, Sweden, Taiwan, and the United Kingdom.","F-0784-2014","Class II","Dietary Supplements packaged in the following configuration: (1) Competitive Nutrition, Healthy Digest, packaged in 90-capsule bottles (SKU 83314). Firm name on the label is Competitive Nutrition, Monaca, PA; (2) New Earthlings Nutritionals, Healthy Digest, Complete Digestive Enzyme Formula packaged in 90-capsule bottles (SKU 54626). Firm name on the label is Guest Chiropractic Clinic, Inman, SC; (3) Doctor Faz, Healthy Digest, Complete Digestive Enzyme Formula, packaged in 90-capsule bottles (SKU 54555). Firm name on the bottle is National Enzyme Company, Forsyth, MO; (4) Healthy Digest, Complete Digestive Enzyme Formula, packaged in 90-capsule bottles (SKU 54784). Firm name on the bottle is Natural Solutions 101, Walnut Shade, MO; (5) NEC, Healthy Digest, Full Spectrum Digestion, packaged in 90-capsule bottles (SKU 54169). Firm name on the label is National Enzyme Company, Forsyth, MO; (6) Solutions Rx, DIGESTIVE WELLNESS, COMPLETE DIGESTIVE ENZYME FORMULA, packaged in 90-capsule bottles (SKU 54608). Firm name on the bottle is Pharmacy & Healthcare Solutions, Saltillo, MS; (7) The Essentials, Ultra Professional, Digestive Essentials, Complete Digestive Enzyme Formula, packaged in 90-capsule bottles (SKU 54512). Firm name on the label is Ask The Pharmacist, Oakmont, PA; (8) FeelIt Healthy Digest, Complete Digestive Enzyme Formula, packaged in 90-capsule bottles (SKU 54872). Firm name on the label is Victory International Group, Irvine, CA;","Lot #'s: 54770000, 54626000, 54626001, 54626002, 54555002, 54784000, 54169005, 54169006, 54608001, 54512002, 54512003, 54512004, 54512005, 54512006, 54512007, and 54872000",,"1751 bottles.","Firm is recalling dietary supplements containing a raw material which may contain >0.3 ppb chloramphenicol",10/30/2013,"10/30/2013",12/18/2013,"12/18/2013"
"Food",66658,"Ongoing","National Enzyme Co","Forsyth","MO","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Domestic distribution of the product is nationwide with direct accounts in 27 states in all geographical regions. Foreign distribution consists of direct accounts in the following countries: Canada, China, Malaysia, Norway, Slovakia, South Korea, Sweden, Taiwan, and the United Kingdom.","F-0763-2014","Class II","Bulk 9399 OceanwideUSA DIGESTENZY capsules, packaged in poly bags in corrugated boxes (for domestic distribution) or fiber drums (for international distribution) (SKU 92033); ","Lot #: 92033003",,"106847 bulk capsules","Firm is recalling dietary supplements containing a raw material which may contain >0.3 ppb chloramphenicol",10/30/2013,"10/30/2013",12/18/2013,"12/18/2013"
"Food",66658,"Ongoing","National Enzyme Co","Forsyth","MO","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Domestic distribution of the product is nationwide with direct accounts in 27 states in all geographical regions. Foreign distribution consists of direct accounts in the following countries: Canada, China, Malaysia, Norway, Slovakia, South Korea, Sweden, Taiwan, and the United Kingdom.","F-0800-2014","Class II","Bulk C434 Shanghai Enzyme Blend B powder, packaged in varying quantities within poly bags within corrugated boxes (for domestic distribution) or fiber drums (for international distribution) (SKU 83419);","Lot #: 83419000 and 83419001",,"567.04 kg of powder","Firm is recalling dietary supplements containing a raw material which may contain >0.3 ppb chloramphenicol",10/30/2013,"10/30/2013",12/18/2013,"12/18/2013"
"Food",66658,"Ongoing","National Enzyme Co","Forsyth","MO","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Domestic distribution of the product is nationwide with direct accounts in 27 states in all geographical regions. Foreign distribution consists of direct accounts in the following countries: Canada, China, Malaysia, Norway, Slovakia, South Korea, Sweden, Taiwan, and the United Kingdom.","F-0757-2014","Class II","8532 Kirkman MaxEnzComp w/DP packaged in unlabeled 120-capsule bottles (SKU 53854)","Lot #'s: 53854008, 53854010, 53854012, 53854013, and 53854014",,"3642 bottles.","Firm is recalling dietary supplements containing a raw material which may contain >0.3 ppb chloramphenicol",10/30/2013,"10/30/2013",12/18/2013,"12/18/2013"
"Food",66658,"Ongoing","National Enzyme Co","Forsyth","MO","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Domestic distribution of the product is nationwide with direct accounts in 27 states in all geographical regions. Foreign distribution consists of direct accounts in the following countries: Canada, China, Malaysia, Norway, Slovakia, South Korea, Sweden, Taiwan, and the United Kingdom.","F-0801-2014","Class II","Enzyme - Travnie Extra, Formula C500, packaged in 30-capsule bottles (SKU 54513). Firm name on the label is National Enzyme Company;","Lot #: 54513000",,"5 bottles","Firm is recalling dietary supplements containing a raw material which may contain >0.3 ppb chloramphenicol",10/30/2013,"10/30/2013",12/18/2013,"12/18/2013"
"Food",66658,"Ongoing","National Enzyme Co","Forsyth","MO","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Domestic distribution of the product is nationwide with direct accounts in 27 states in all geographical regions. Foreign distribution consists of direct accounts in the following countries: Canada, China, Malaysia, Norway, Slovakia, South Korea, Sweden, Taiwan, and the United Kingdom.","F-0745-2014","Class II","Dietary Supplements packaged in the following configurations: (1) Houston Enzymes, No-Fenol, Multi-Enzyme Product for Digestion of Phenolic Foods and Fiber packaged in 90-capsule bottles (SKU 52437). Firm name on the label is Houston Nutraceuticals, Inc. (HNI), Siloam, AR; (2) 5327 Houston NO-FENOL blk 1v, Bulk Capsules (SKU 91456)","Lot #'s: 52437042, 52437043, 52437044, 52437045, 52437046, 52437047, 52437048, 52437049, 52437050, 52437051, 52437052, 52437053, 52437054, and 91456000",,"14519 bottles and 50000 bulk capsules","Firm is recalling dietary supplements containing a raw material which may contain >0.3 ppb chloramphenicol",10/30/2013,"10/30/2013",12/18/2013,"12/18/2013"
"Food",66658,"Ongoing","National Enzyme Co","Forsyth","MO","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Domestic distribution of the product is nationwide with direct accounts in 27 states in all geographical regions. Foreign distribution consists of direct accounts in the following countries: Canada, China, Malaysia, Norway, Slovakia, South Korea, Sweden, Taiwan, and the United Kingdom.","F-0774-2014","Class II","Bulk A123 ORTHOMOLECULAR DIGESTIV powder (SKU 83202), packaged in poly bags in corrugated boxes (for domestic distribution) or fiber drums (for international distribution)","Lot #'s: 83202029, 83202031, 83202032, 83202033, 83202034, 83202035, 83202036, 83202038, 83202039, 83202040, and 83202041",,"1245.14 kg of powder","Firm is recalling dietary supplements containing a raw material which may contain >0.3 ppb chloramphenicol",10/30/2013,"10/30/2013",12/18/2013,"12/18/2013"
"Food",66658,"Ongoing","National Enzyme Co","Forsyth","MO","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Domestic distribution of the product is nationwide with direct accounts in 27 states in all geographical regions. Foreign distribution consists of direct accounts in the following countries: Canada, China, Malaysia, Norway, Slovakia, South Korea, Sweden, Taiwan, and the United Kingdom.","F-0812-2014","Class II","Bulk D008 Glykon Tech Digestive B powder, packaged in varying quantities within poly bags within corrugated boxes (for domestic distribution) or fiber drums (for international distribution) (SKU 83453)","Lot #'s: 83453000",,"25.87 kg of powder","Firm is recalling dietary supplements containing a raw material which may contain >0.3 ppb chloramphenicol",10/30/2013,"10/30/2013",12/18/2013,"12/18/2013"
"Food",66658,"Ongoing","National Enzyme Co","Forsyth","MO","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Domestic distribution of the product is nationwide with direct accounts in 27 states in all geographical regions. Foreign distribution consists of direct accounts in the following countries: Canada, China, Malaysia, Norway, Slovakia, South Korea, Sweden, Taiwan, and the United Kingdom.","F-0802-2014","Class II","Bulk C542 Vitakost Low Carb Diet, packaged in varying quantities within poly bags within corrugated boxes (for domestic distribution) or fiber drums (for international distribution) (SKU 92544);","Lot #: 92544001",,"209,586 bulk capsules","Firm is recalling dietary supplements containing a raw material which may contain >0.3 ppb chloramphenicol",10/30/2013,"10/30/2013",12/18/2013,"12/18/2013"
"Food",66658,"Ongoing","National Enzyme Co","Forsyth","MO","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Domestic distribution of the product is nationwide with direct accounts in 27 states in all geographical regions. Foreign distribution consists of direct accounts in the following countries: Canada, China, Malaysia, Norway, Slovakia, South Korea, Sweden, Taiwan, and the United Kingdom.","F-0747-2014","Class II","Dietary Supplement packaged in the following configurations: (1) KIRKMAN, Enzym-Complete / DPP-IV, Broad Spectrum Digestion Formula with Dipeptidyl Peptidase IV Analog, packaged in 60-capsule bottles (SKU 52587), 120-capsule bottles (SKU 52588), and 200-capsule bottles (SKU 53853). Manufactured exclusively for KIRKMAN, Lake Oswego, OR; (2) KIRKMAN, EnZym-Complete / DPP-IV, GF/CF Enzyme Dietary Supplement, packaged in 200-capsule bottles (SKU 54956). Manufactured exclusively for KIRKMAN, Lake Oswego, OR;","Lot #'s: 52587047, 52587048, 52587049, 52587050, 52588047, 52588048, 52588049, 52588050, 52588051, 53853006, 53853007, 53853008, 53853009, 53853010, and 54956000",,"16733 bottles","Firm is recalling dietary supplements containing a raw material which may contain >0.3 ppb chloramphenicol",10/30/2013,"10/30/2013",12/18/2013,"12/18/2013"
"Food",66658,"Ongoing","National Enzyme Co","Forsyth","MO","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Domestic distribution of the product is nationwide with direct accounts in 27 states in all geographical regions. Foreign distribution consists of direct accounts in the following countries: Canada, China, Malaysia, Norway, Slovakia, South Korea, Sweden, Taiwan, and the United Kingdom.","F-0781-2014","Class II","Bulk A776 Healthline Nutri Pet Di powder, packaged in varying quantities within poly bags within corrugated boxes (for domestic distribution) or fiber drums (for international distribution) (SKU 83287);","Lot #'s: 83287006, 83287007, 83287008, 83287009, 83287010, 83287011, and 83287012;",,"207.74 kg of powder","Firm is recalling dietary supplements containing a raw material which may contain >0.3 ppb chloramphenicol",10/30/2013,"10/30/2013",12/18/2013,"12/18/2013"
"Food",66658,"Ongoing","National Enzyme Co","Forsyth","MO","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Domestic distribution of the product is nationwide with direct accounts in 27 states in all geographical regions. Foreign distribution consists of direct accounts in the following countries: Canada, China, Malaysia, Norway, Slovakia, South Korea, Sweden, Taiwan, and the United Kingdom.","F-0740-2014","Class II","enzyme essentials, OxiCellZyme, Enzyme Supplement with Herbs, packaged in 90-(SKU 54929) and 180-(SKU 52270) capsule bottles.","Lot Numbers: 52270018, 52270019, and 54929000",,"1260 bottles","Firm is recalling dietary supplements containing a raw material which may contain >0.3 ppb chloramphenicol",10/30/2013,"10/30/2013",12/18/2013,"12/18/2013"
"Food",66658,"Ongoing","National Enzyme Co","Forsyth","MO","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Domestic distribution of the product is nationwide with direct accounts in 27 states in all geographical regions. Foreign distribution consists of direct accounts in the following countries: Canada, China, Malaysia, Norway, Slovakia, South Korea, Sweden, Taiwan, and the United Kingdom.","F-0793-2014","Class II","Bulk B983 Vitamin Shoppe Advnaced powder, packaged in varying quantities within poly bags within corrugated boxes (for domestic distribution) or fiber drums (for international distribution) (SKU 83408);","Lot #: 83408000",,"1.41 kg of powder","Firm is recalling dietary supplements containing a raw material which may contain >0.3 ppb chloramphenicol",10/30/2013,"10/30/2013",12/18/2013,"12/18/2013"
"Food",66658,"Ongoing","National Enzyme Co","Forsyth","MO","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Domestic distribution of the product is nationwide with direct accounts in 27 states in all geographical regions. Foreign distribution consists of direct accounts in the following countries: Canada, China, Malaysia, Norway, Slovakia, South Korea, Sweden, Taiwan, and the United Kingdom.","F-0735-2014","Class II","Dietary Supplement packaged in the following configuration: (1)Nutri-Essence Digestion Super Potency Enzymes & Herbs with patent-pending CereCalase Plus, packaged in 180-(SKU 51832) capsule bottles. The firm name on the label is Enzymes, Inc., Parkville, MO (2) Positive Changes Hypnosis Centers Enzymes Digestion Dietary Supplement packaged in 60-(SKU 53793) and 180-(SKU 53794) capsule bottles. The firm name on the bottle is Positive Changes Hypnosis Center Dublin, OH 43017 ","Lot Numbers: 51832027, 53793001, 53793002, 53794001, and 54426000",,"1,587 bottles","Firm is recalling dietary supplements containing a raw material which may contain >0.3 ppb chloramphenicol",10/30/2013,"10/30/2013",12/18/2013,"12/18/2013"
"Food",66658,"Ongoing","National Enzyme Co","Forsyth","MO","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Domestic distribution of the product is nationwide with direct accounts in 27 states in all geographical regions. Foreign distribution consists of direct accounts in the following countries: Canada, China, Malaysia, Norway, Slovakia, South Korea, Sweden, Taiwan, and the United Kingdom.","F-0734-2014","Class II","Houston Enzymes TriEnza with DPP IV Activity, Broad-Spectrum Enzyme Product for general Digestive Support, packaged in 90-(SKU 53379) and 180-(SKU 53380) capsule bottles. The firm name on the label is Houston Nutraceuticals, Inc. (HNI), Siloam Springs, AR (2) 9212 TRIENZA Bulk Capsules (SKU 91980) packaged in varying quantities in poly bags within corrugated containers.","Lot Numbers: 53379030, 53379031, 53379032, 53379034, 53379035, 53379036, 53379037, 53379038, 53379039, 53379040, 53379041, 53380079, 53380081, 53380083, 53380085, 53380086, 53380087, 53380088, 53380089, 53380090, 53380091, 53380092, 53380093, 53380094, 53380095, 53380096, 53380097, 53380098, 53380099, 53380100, 53380101, 53380102, 53380103, 53380104, 53380105, 53380106, 53380107, 53380108, 53380109, 53380110, 53380111, 53380113, 53380114, 91980002, 91980003, and 91980004",,"54,887 bottles, and 327,139 bulk capsules","Firm is recalling dietary supplements containing a raw material which may contain >0.3 ppb chloramphenicol",10/30/2013,"10/30/2013",12/18/2013,"12/18/2013"
"Food",66658,"Ongoing","National Enzyme Co","Forsyth","MO","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Domestic distribution of the product is nationwide with direct accounts in 27 states in all geographical regions. Foreign distribution consists of direct accounts in the following countries: Canada, China, Malaysia, Norway, Slovakia, South Korea, Sweden, Taiwan, and the United Kingdom.","F-0754-2014","Class II","Dietary Supplements packaged in the following configurations: (1) 7 Lights, FULL SPECTRUM ENZYMES, packaged in 90 capsule bottles (SKU 52785). Firm name on the label is 7 Lights, Black Mountain, NC; (2) 6926 Crusador TempleBuilders, packaged in unlabeled 90 capsule bottles (SKU 54335); ","Lot #'s: 52785003 and 54335000",,"647 bottles","Firm is recalling dietary supplements containing a raw material which may contain >0.3 ppb chloramphenicol",10/30/2013,"10/30/2013",12/18/2013,"12/18/2013"
"Food",66658,"Ongoing","National Enzyme Co","Forsyth","MO","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Domestic distribution of the product is nationwide with direct accounts in 27 states in all geographical regions. Foreign distribution consists of direct accounts in the following countries: Canada, China, Malaysia, Norway, Slovakia, South Korea, Sweden, Taiwan, and the United Kingdom.","F-0765-2014","Class II","Bulk 9665 BioSan Labs Hi Potency capsules, packaged in poly bags in corrugated boxes (for domestic distribution) or fiber drums (for international distribution) (SKU 92093); ","Lot #'s: 92093010, 92093011, 92093012, 92093013, 92093014, 92093015, and 92093016",,"2,134,857 bulk capsules","Firm is recalling dietary supplements containing a raw material which may contain >0.3 ppb chloramphenicol",10/30/2013,"10/30/2013",12/18/2013,"12/18/2013"
"Food",66658,"Ongoing","National Enzyme Co","Forsyth","MO","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Domestic distribution of the product is nationwide with direct accounts in 27 states in all geographical regions. Foreign distribution consists of direct accounts in the following countries: Canada, China, Malaysia, Norway, Slovakia, South Korea, Sweden, Taiwan, and the United Kingdom.","F-0808-2014","Class II","Bulk C676 BnG Global Digestive Blend powder, packaged in varying quantities within poly bags within corrugated boxes (for domestic distribution) or fiber drums (for international distribution) (SKU 83430)","Lot #: 83430001 and 83430002",,"108 kg of powder","Firm is recalling dietary supplements containing a raw material which may contain >0.3 ppb chloramphenicol",10/30/2013,"10/30/2013",12/18/2013,"12/18/2013"
"Food",66658,"Ongoing","National Enzyme Co","Forsyth","MO","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Domestic distribution of the product is nationwide with direct accounts in 27 states in all geographical regions. Foreign distribution consists of direct accounts in the following countries: Canada, China, Malaysia, Norway, Slovakia, South Korea, Sweden, Taiwan, and the United Kingdom.","F-0764-2014","Class II","Bulk 9414 PROTHERA CANDIDACHLOREL powder, packaged in poly bags in corrugated boxes (for domestic distribution) or fiber drums (for international distribution) (SKU 83056); ","Lot #: 83056004;",,"25.86 kg of powder","Firm is recalling dietary supplements containing a raw material which may contain >0.3 ppb chloramphenicol",10/30/2013,"10/30/2013",12/18/2013,"12/18/2013"
"Food",66658,"Ongoing","National Enzyme Co","Forsyth","MO","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Domestic distribution of the product is nationwide with direct accounts in 27 states in all geographical regions. Foreign distribution consists of direct accounts in the following countries: Canada, China, Malaysia, Norway, Slovakia, South Korea, Sweden, Taiwan, and the United Kingdom.","F-0772-2014","Class II","Bulk A036 Threshold Ess Enz Ultra capsules, packaged in poly bags in corrugated boxes (for domestic distribution) or fiber drums (for international distribution) (SKU 92131).","Lot #'s: 92131009 and 92131010",,"996,765 bulk capsules","Firm is recalling dietary supplements containing a raw material which may contain >0.3 ppb chloramphenicol",10/30/2013,"10/30/2013",12/18/2013,"12/18/2013"
"Food",66658,"Ongoing","National Enzyme Co","Forsyth","MO","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Domestic distribution of the product is nationwide with direct accounts in 27 states in all geographical regions. Foreign distribution consists of direct accounts in the following countries: Canada, China, Malaysia, Norway, Slovakia, South Korea, Sweden, Taiwan, and the United Kingdom.","F-0798-2014","Class II","Multi Plant Enzyme Tablets, packaged 60 tablet bottles(SKU 54451). Firm name on the label is Wedar Nutrasource Inc., Hacienda Height, CA;","Lot #: 54451002",,"5328 bottles","Firm is recalling dietary supplements containing a raw material which may contain >0.3 ppb chloramphenicol",10/30/2013,"10/30/2013",12/18/2013,"12/18/2013"
"Food",66658,"Ongoing","National Enzyme Co","Forsyth","MO","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Domestic distribution of the product is nationwide with direct accounts in 27 states in all geographical regions. Foreign distribution consists of direct accounts in the following countries: Canada, China, Malaysia, Norway, Slovakia, South Korea, Sweden, Taiwan, and the United Kingdom.","F-0813-2014","Class II","Bulk D103 Life Tree Digestive Ble powder packaged in varying quantities within poly bags within corrugated boxes (for domestic distribution) or fiber drums (for international distribution) (SKU 83466). ","Lot #'s: 83466000",,"25.86 kg of powder","Firm is recalling dietary supplements containing a raw material which may contain >0.3 ppb chloramphenicol",10/30/2013,"10/30/2013",12/18/2013,"12/18/2013"
"Food",66658,"Ongoing","National Enzyme Co","Forsyth","MO","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Domestic distribution of the product is nationwide with direct accounts in 27 states in all geographical regions. Foreign distribution consists of direct accounts in the following countries: Canada, China, Malaysia, Norway, Slovakia, South Korea, Sweden, Taiwan, and the United Kingdom.","F-0743-2014","Class II","4764 Higher Nature Supergest, Bulk Capsules, packaged in varying quantities in poly bags placed inside fiber drums for foreign export.","Lot #'s: 91397048, 91397050, 91397053, 91397054, 91397055, 91397056, and 91397057",,"1,725,998 bulk capsules","Firm is recalling dietary supplements containing a raw material which may contain >0.3 ppb chloramphenicol",10/30/2013,"10/30/2013",12/18/2013,"12/18/2013"
"Food",66658,"Ongoing","National Enzyme Co","Forsyth","MO","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Domestic distribution of the product is nationwide with direct accounts in 27 states in all geographical regions. Foreign distribution consists of direct accounts in the following countries: Canada, China, Malaysia, Norway, Slovakia, South Korea, Sweden, Taiwan, and the United Kingdom.","F-0788-2014","Class II","TriEnza Powder with DPP IV Activity, packaged 105 gram bottles (SKU 54045). Firm name on the label is Houston Nutraceuticals, Inc., (HNI), Siloam Springs, AR;","Lot #'s: 54045003, 54045005, 54045006, 54045007, and 54045008",,"2834 bottles","Firm is recalling dietary supplements containing a raw material which may contain >0.3 ppb chloramphenicol",10/30/2013,"10/30/2013",12/18/2013,"12/18/2013"
"Food",66658,"Ongoing","National Enzyme Co","Forsyth","MO","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Domestic distribution of the product is nationwide with direct accounts in 27 states in all geographical regions. Foreign distribution consists of direct accounts in the following countries: Canada, China, Malaysia, Norway, Slovakia, South Korea, Sweden, Taiwan, and the United Kingdom.","F-0807-2014","Class II","Bulk C665 powder, packaged in varying quantities within poly bags within corrugated boxes (for domestic distribution) or fiber drums (for international distribution) (SKU 7256000)","Lot #: 72456000",,"5 kg","Firm is recalling dietary supplements containing a raw material which may contain >0.3 ppb chloramphenicol",10/30/2013,"10/30/2013",12/18/2013,"12/18/2013"
"Food",66658,"Ongoing","National Enzyme Co","Forsyth","MO","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Domestic distribution of the product is nationwide with direct accounts in 27 states in all geographical regions. Foreign distribution consists of direct accounts in the following countries: Canada, China, Malaysia, Norway, Slovakia, South Korea, Sweden, Taiwan, and the United Kingdom.","F-0787-2014","Class II","Dietary Supplements packaged in the following configurations: (1) Bulk B341 Shanghai Actizyme Tab6 tablets, packaged in varying quantities within poly bags within corrugated boxes (for domestic distribution) or fiber drums (for international distribution) (SKU 92275); (2) ActiFIT, Actizyme, Digest Miracle, packaged in 60-tablet bottles (SKU 54955). Firm name on the label is ActiFit Biotechnology Co, Bellevue, WA.","Lot #'s: 92275001, 92275003, and 54955000",,"321,893 bulk capsules, 3714 bottles.","Firm is recalling dietary supplements containing a raw material which may contain >0.3 ppb chloramphenicol",10/30/2013,"10/30/2013",12/18/2013,"12/18/2013"
"Food",66658,"Ongoing","National Enzyme Co","Forsyth","MO","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Domestic distribution of the product is nationwide with direct accounts in 27 states in all geographical regions. Foreign distribution consists of direct accounts in the following countries: Canada, China, Malaysia, Norway, Slovakia, South Korea, Sweden, Taiwan, and the United Kingdom.","F-0785-2014","Class II","Dietary Supplements packaged in the following configuration: (1) NEC Healthy Pre Menopausal, Feminine Support for Active Women, packaged in 60-capsule bottles (SKU 54389). Firm name on the label is National Enzyme Company, Forsyth, MO; (2) Root 86, Healthy Pre Menopausal, Healthy Vitality In Active Women packaged in 60-capsule bottles (SKU 54632). Firm name on the label is Root 86, Ridgedale, MO;","Lot #: 53985002, 54389001, and 54632000",,"31 bottles","Firm is recalling dietary supplements containing a raw material which may contain >0.3 ppb chloramphenicol",10/30/2013,"10/30/2013",12/18/2013,"12/18/2013"
"Food",66658,"Ongoing","National Enzyme Co","Forsyth","MO","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Domestic distribution of the product is nationwide with direct accounts in 27 states in all geographical regions. Foreign distribution consists of direct accounts in the following countries: Canada, China, Malaysia, Norway, Slovakia, South Korea, Sweden, Taiwan, and the United Kingdom.","F-0756-2014","Class II","Bulk 7775 GreenPlanet Enzymeblend Powder packaged in poly bags within fiber drums (SKU 82566)","Lot #: 82566000",,"52.96 kg of powder","Firm is recalling dietary supplements containing a raw material which may contain >0.3 ppb chloramphenicol",10/30/2013,"10/30/2013",12/18/2013,"12/18/2013"
"Food",66658,"Ongoing","National Enzyme Co","Forsyth","MO","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Domestic distribution of the product is nationwide with direct accounts in 27 states in all geographical regions. Foreign distribution consists of direct accounts in the following countries: Canada, China, Malaysia, Norway, Slovakia, South Korea, Sweden, Taiwan, and the United Kingdom.","F-0768-2014","Class II","Bulk 9809 ENZYMEDICA CARBGESTKOSH capsules, packaged in poly bags in corrugated boxes (for domestic distribution) or fiber drums (for international distribution) (SKU 92103).","Lot #'s: 92099007",,"54,000 bulk capsules","Firm is recalling dietary supplements containing a raw material which may contain >0.3 ppb chloramphenicol",10/30/2013,"10/30/2013",12/18/2013,"12/18/2013"
"Food",66658,"Ongoing","National Enzyme Co","Forsyth","MO","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Domestic distribution of the product is nationwide with direct accounts in 27 states in all geographical regions. Foreign distribution consists of direct accounts in the following countries: Canada, China, Malaysia, Norway, Slovakia, South Korea, Sweden, Taiwan, and the United Kingdom.","F-0776-2014","Class II","Dietary Supplement Formula ID A200; Packaged in the following configuration: Bulk A200 Nutr Provider Comp Dige capsules (SKU 92132), packaged in varying quantities within poly bags in corrugated boxes (for domestic distribution) or fiber drums (for international distribution)","Lot #: 92132004",,"106,743 bulk capsules","Firm is recalling dietary supplements containing a raw material which may contain >0.3 ppb chloramphenicol",10/30/2013,"10/30/2013",12/18/2013,"12/18/2013"
"Food",66658,"Ongoing","National Enzyme Co","Forsyth","MO","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Domestic distribution of the product is nationwide with direct accounts in 27 states in all geographical regions. Foreign distribution consists of direct accounts in the following countries: Canada, China, Malaysia, Norway, Slovakia, South Korea, Sweden, Taiwan, and the United Kingdom.","F-0741-2014","Class II","WELLZYMES, Digestive Health, Enzyme Supplement packaged in 60-(SKU 52235) capsule bottles. Manufactured exclusively for enzymes, inc. Kansas City, MO","Lot Numbers: 52235014, 52235015, and 52235016",,"2503 bottles","Firm is recalling dietary supplements containing a raw material which may contain >0.3 ppb chloramphenicol",10/30/2013,"10/30/2013",12/18/2013,"12/18/2013"
"Food",66658,"Ongoing","National Enzyme Co","Forsyth","MO","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Domestic distribution of the product is nationwide with direct accounts in 27 states in all geographical regions. Foreign distribution consists of direct accounts in the following countries: Canada, China, Malaysia, Norway, Slovakia, South Korea, Sweden, Taiwan, and the United Kingdom.","F-0803-2014","Class II","Dietary Supplements packaged in the following configurations: (1) Carbo Converter-I powder, packaged 25 gram bottles (SKU 54663). Firm name on the label is National Enzyme Company, Forsyth, MO; (2) C560 NEC Carb Converter Blen packaged in unlabeled, 25 gram bottles.","Lot #: 54663000 and 54665000",,"101 bottles","Firm is recalling dietary supplements containing a raw material which may contain >0.3 ppb chloramphenicol",10/30/2013,"10/30/2013",12/18/2013,"12/18/2013"
"Food",66658,"Ongoing","National Enzyme Co","Forsyth","MO","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Domestic distribution of the product is nationwide with direct accounts in 27 states in all geographical regions. Foreign distribution consists of direct accounts in the following countries: Canada, China, Malaysia, Norway, Slovakia, South Korea, Sweden, Taiwan, and the United Kingdom.","F-0752-2014","Class II","Dietary Supplements packaged in the following configurations: (1) Healthy Reflections, Amylase Amylolytic Enzymes Dietary Supplement, packaged in 90-capsule bottles (SKU 52896). Firm name on the label is Healthy Reflections a division of Healthy Alternatives, Garfield, MN; (2) 6895 Hlthy Alternatives Amyl, packaged in 90-capsule unlabeled bottles (SKU 54328)","Lot #'s: 52896006 and 54328000",,"1187 bottles","Firm is recalling dietary supplements containing a raw material which may contain >0.3 ppb chloramphenicol",10/30/2013,"10/30/2013",12/18/2013,"12/18/2013"
"Food",66658,"Ongoing","National Enzyme Co","Forsyth","MO","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Domestic distribution of the product is nationwide with direct accounts in 27 states in all geographical regions. Foreign distribution consists of direct accounts in the following countries: Canada, China, Malaysia, Norway, Slovakia, South Korea, Sweden, Taiwan, and the United Kingdom.","F-0771-2014","Class II","Bulk 9896 BIOMEDICALRESEARCH DIGE capsules, packaged in poly bags in corrugated boxes (for domestic distribution) or fiber drums (for international distribution) (SKU 92115).","Lot #'s: 92115011, 92115012, 92115013, 92115014, 92115015, and 92115016",,"6,139,669 bulk capsules","Firm is recalling dietary supplements containing a raw material which may contain >0.3 ppb chloramphenicol",10/30/2013,"10/30/2013",12/18/2013,"12/18/2013"
"Food",66658,"Ongoing","National Enzyme Co","Forsyth","MO","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Domestic distribution of the product is nationwide with direct accounts in 27 states in all geographical regions. Foreign distribution consists of direct accounts in the following countries: Canada, China, Malaysia, Norway, Slovakia, South Korea, Sweden, Taiwan, and the United Kingdom.","F-0758-2014","Class I","Bulk 877 HOLISTIC DIGESTIVE MULTI packaged in poly bags within fiber drums (SKU 90461)","Lot #'s: 90461064, 90461065, 90461066, 90461067, and 90461068",,"4,572,176 capsules","Firm is recalling dietary supplements containing a raw material which may contain >0.3 ppb chloramphenicol",10/30/2013,"10/30/2013",12/18/2013,"12/18/2013"
"Food",66658,"Ongoing","National Enzyme Co","Forsyth","MO","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Domestic distribution of the product is nationwide with direct accounts in 27 states in all geographical regions. Foreign distribution consists of direct accounts in the following countries: Canada, China, Malaysia, Norway, Slovakia, South Korea, Sweden, Taiwan, and the United Kingdom.","F-0750-2014","Class II","Dietary Supplement packaged in the following configurations: (1) WELLZYMES, Carbohydrate Digestion, Enzyme Supplement packaged in 90-capsule bottles (SKU 52644). Manufactured exclusively for enzymes, inc., Parkville, MO.; (2) 6306 WellZymes CarboDigest U, packaged in 90-capsule, unlabeled bottles (SKU 54799);","Lot #'s 52644004 and 54799000",,"565 bottles ","Firm is recalling dietary supplements containing a raw material which may contain >0.3 ppb chloramphenicol",10/30/2013,"10/30/2013",12/18/2013,"12/18/2013"
"Food",66658,"Ongoing","National Enzyme Co","Forsyth","MO","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Domestic distribution of the product is nationwide with direct accounts in 27 states in all geographical regions. Foreign distribution consists of direct accounts in the following countries: Canada, China, Malaysia, Norway, Slovakia, South Korea, Sweden, Taiwan, and the United Kingdom.","F-0753-2014","Class II","Dietary Supplements packaged in the following configurations: (1) Bulk 6916 Shanghai DigestiveBlend powder, packaged in varying quantities in poly bags within fiber drums (SKU 83274); (2) Bulk 6916 WEDAR DIGESTIVEBLEND powder, packaged in varying quantities in poly bags within fiber drums (SKU 82426); ","Lot #'s: 83274014, 83274015, 83274016, 83274017, 83274018, 83274019, 83274020, 83274021, 83274022, 83274023, 83274025, 83274026, 83274027, 83274028, 83274035, 82426059, and 82426060",,"6657.39 kg of powder","Firm is recalling dietary supplements containing a raw material which may contain >0.3 ppb chloramphenicol",10/30/2013,"10/30/2013",12/18/2013,"12/18/2013"
"Food",66658,"Ongoing","National Enzyme Co","Forsyth","MO","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Domestic distribution of the product is nationwide with direct accounts in 27 states in all geographical regions. Foreign distribution consists of direct accounts in the following countries: Canada, China, Malaysia, Norway, Slovakia, South Korea, Sweden, Taiwan, and the United Kingdom.","F-0751-2014","Class II","Dietary Supplement packaged in the following configurations: (1) KIRKMAN Phenol Assist, packaged in 90-capsule bottles (SKU 52640). Manufactured exclusively for Kirkman, Lake Oswego, OR.; (2) 6379 Kirk Phenol Assist UNL, packaged in 90-capsule unlabeled bottles (SKU 53855)","Lot #'s: 52640015, 53855003, and 53855004",,"3455 bottles.","Firm is recalling dietary supplements containing a raw material which may contain >0.3 ppb chloramphenicol",10/30/2013,"10/30/2013",12/18/2013,"12/18/2013"
"Food",66658,"Ongoing","National Enzyme Co","Forsyth","MO","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Domestic distribution of the product is nationwide with direct accounts in 27 states in all geographical regions. Foreign distribution consists of direct accounts in the following countries: Canada, China, Malaysia, Norway, Slovakia, South Korea, Sweden, Taiwan, and the United Kingdom.","F-0814-2014","Class II","Dietary Supplements packaged in the following configurations: (1) Bulk Isolase-I powder packaged in varying quantities within poly bags within corrugated boxes (for domestic distribution) or fiber drums (for international distribution) (SKU 71453); (2) Bulk Bision Isolase powder packaged in varying quantities within poly bags within corrugated boxes (for domestic distribution) or fiber drums (for international distribution) (SKU 72073); (3) Bulk Isolase (Shanghai) powder packaged in varying quantities within poly bags within corrugated boxes (for domestic distribution) or fiber drums (for international distribution) (SKU 72077); (4) Bulk Isolase (Wedar) powder packaged in varying quantities within poly bags within corrugated boxes (for domestic distribution) or fiber drums (for international distribution) (SKU 72080); (5) Bulk Isolase (Nutri Sport) powder packaged in varying quantities within poly bags within corrugated boxes (for domestic distribution) or fiber drums (for international distribution) (SKU 72106);","Lot #'s: 71453155, 72073003, 72073004, 71453148, 71453138, 71453142, 71453143, 71453144, 71453137, 71453139, 71453145, 71453146, 71453147, 71453149, 71453152, 71453153, 71453156, 72106012, 72106013, 72106014, 72106015, 72106018, 72106019, 72106020, 72106021, 72106022, 72106024, 72106025, 71453141, 71453154, 72077001, 72080006, 72080007, 72080008, and 72080009",,"1827.13 kg of powder","Firm is recalling dietary supplements containing a raw material which may contain >0.3 ppb chloramphenicol",10/30/2013,"10/30/2013",12/18/2013,"12/18/2013"
"Food",66658,"Ongoing","National Enzyme Co","Forsyth","MO","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Domestic distribution of the product is nationwide with direct accounts in 27 states in all geographical regions. Foreign distribution consists of direct accounts in the following countries: Canada, China, Malaysia, Norway, Slovakia, South Korea, Sweden, Taiwan, and the United Kingdom.","F-0737-2014","Class II","Advanced Formula, CarbohydrEnz, packaged in 60-(SKU 52083) capsule bottles. The firm name on the label is Enzymes, Inc., Parkville, MO ","Lot#: 52083008",,"900 bottles","Firm is recalling dietary supplements containing a raw material which may contain >0.3 ppb chloramphenicol",10/30/2013,"10/30/2013",12/18/2013,"12/18/2013"
"Food",66658,"Ongoing","National Enzyme Co","Forsyth","MO","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Domestic distribution of the product is nationwide with direct accounts in 27 states in all geographical regions. Foreign distribution consists of direct accounts in the following countries: Canada, China, Malaysia, Norway, Slovakia, South Korea, Sweden, Taiwan, and the United Kingdom.","F-0799-2014","Class II","Dietary Supplements packaged in the following configurations: (1) Heryben, Eumin Integrated Plant Enzymes, packaged 60 capsule bottles(SKU 54440). Firm name on the label is ActiFit Biotechnology, Bellevue, WA; (2) Bulk C269 Shanghai Digestive Blen capsules, packaged in varying quantities within poly bags within corrugated boxes (for domestic distribution) or fiber drums (for international distribution) (SKU 92473);","Lot #: 54440000 and 92473000",,"3640 bottles and 210,098 bulk capsules","Firm is recalling dietary supplements containing a raw material which may contain >0.3 ppb chloramphenicol",10/30/2013,"10/30/2013",12/18/2013,"12/18/2013"
"Food",66658,"Ongoing","National Enzyme Co","Forsyth","MO","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Domestic distribution of the product is nationwide with direct accounts in 27 states in all geographical regions. Foreign distribution consists of direct accounts in the following countries: Canada, China, Malaysia, Norway, Slovakia, South Korea, Sweden, Taiwan, and the United Kingdom.","F-0782-2014","Class II","Bulk A957 Nutra Med Digestive Bul powder, packaged in varying quantities within poly bags within corrugated boxes (for domestic distribution) or fiber drums (for international distribution) (SKU 83318);","Lot #'s: 83318002, 83318003, and 83318004",,"98.67 kg of powder","Firm is recalling dietary supplements containing a raw material which may contain >0.3 ppb chloramphenicol",10/30/2013,"10/30/2013",12/18/2013,"12/18/2013"
"Food",66658,"Ongoing","National Enzyme Co","Forsyth","MO","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Domestic distribution of the product is nationwide with direct accounts in 27 states in all geographical regions. Foreign distribution consists of direct accounts in the following countries: Canada, China, Malaysia, Norway, Slovakia, South Korea, Sweden, Taiwan, and the United Kingdom.","F-0797-2014","Class II","Bulk C184 Ace Health Enzyme Blend powder, packaged in varying quantities within poly bags within corrugated boxes (for domestic distribution) or fiber drums (for international distribution) (SKU 83403);","Lot #: 83403000",,"26.79 kg of powder","Firm is recalling dietary supplements containing a raw material which may contain >0.3 ppb chloramphenicol",10/30/2013,"10/30/2013",12/18/2013,"12/18/2013"
"Food",66658,"Ongoing","National Enzyme Co","Forsyth","MO","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Domestic distribution of the product is nationwide with direct accounts in 27 states in all geographical regions. Foreign distribution consists of direct accounts in the following countries: Canada, China, Malaysia, Norway, Slovakia, South Korea, Sweden, Taiwan, and the United Kingdom.","F-0804-2014","Class II","Cellulase Cellulolytic Enzymes, packaged 100-capsule bottles (SKU 54553). Firm name on the label is Healthy Reflections, Garfield, MN; ","Lot #: 54553000 and 54553001",,"1977 bottles","Firm is recalling dietary supplements containing a raw material which may contain >0.3 ppb chloramphenicol",10/30/2013,"10/30/2013",12/18/2013,"12/18/2013"
"Food",66658,"Ongoing","National Enzyme Co","Forsyth","MO","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Domestic distribution of the product is nationwide with direct accounts in 27 states in all geographical regions. Foreign distribution consists of direct accounts in the following countries: Canada, China, Malaysia, Norway, Slovakia, South Korea, Sweden, Taiwan, and the United Kingdom.","F-0744-2014","Class II","Applied Health, Solutions for Life, Foundation Blue-Green Algae, Detoxify and Regenerate Energy and Immune Booster, Daily Essential Nutrients packaged in 90-capsule bottles (SKU 53623). Firm name on the label is Applied Health Solutions, Scottsdale, AZ.","Lot #'s: 53623003 and 53623004",,"1084 bottles.","Firm is recalling dietary supplements containing a raw material which may contain >0.3 ppb chloramphenicol",10/30/2013,"10/30/2013",12/18/2013,"12/18/2013"
"Food",66658,"Ongoing","National Enzyme Co","Forsyth","MO","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Domestic distribution of the product is nationwide with direct accounts in 27 states in all geographical regions. Foreign distribution consists of direct accounts in the following countries: Canada, China, Malaysia, Norway, Slovakia, South Korea, Sweden, Taiwan, and the United Kingdom.","F-0738-2014","Class II","3989 Bulk TPP TEC DIGEST powder, Transformation Enzyme Corporat, packaged in varying quantities in poly bags within corrugated containers. SKU 81814","Lot#: 81814110 and 81814111",,"103.14 Kg","Firm is recalling dietary supplements containing a raw material which may contain >0.3 ppb chloramphenicol",10/30/2013,"10/30/2013",12/18/2013,"12/18/2013"
"Food",66658,"Ongoing","National Enzyme Co","Forsyth","MO","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Domestic distribution of the product is nationwide with direct accounts in 27 states in all geographical regions. Foreign distribution consists of direct accounts in the following countries: Canada, China, Malaysia, Norway, Slovakia, South Korea, Sweden, Taiwan, and the United Kingdom.","F-0779-2014","Class II","Bulk A322 Houston Chewable Enzyme powder (SKU 83226), packaged in varying quantities within poly bags in corrugated boxes (for domestic distribution) or fiber drums (for international distribution)","Lot #'s: 83226010, 83226011, 83226012, 83226013, 83226014, and 83226015",,"287.21 kg of powder.","Firm is recalling dietary supplements containing a raw material which may contain >0.3 ppb chloramphenicol",10/30/2013,"10/30/2013",12/18/2013,"12/18/2013"
"Food",66658,"Ongoing","National Enzyme Co","Forsyth","MO","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Domestic distribution of the product is nationwide with direct accounts in 27 states in all geographical regions. Foreign distribution consists of direct accounts in the following countries: Canada, China, Malaysia, Norway, Slovakia, South Korea, Sweden, Taiwan, and the United Kingdom.","F-0762-2014","Class II","9326 Kirkman Bacterial Bio 6, packaged in unlabeled 60-capsule bottles (SKU 53666); ","Lot #'s: 53666006, 53666007, 53666008, and 53666009",,"7053 bottles","Firm is recalling dietary supplements containing a raw material which may contain >0.3 ppb chloramphenicol",10/30/2013,"10/30/2013",12/18/2013,"12/18/2013"
"Food",66658,"Ongoing","National Enzyme Co","Forsyth","MO","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Domestic distribution of the product is nationwide with direct accounts in 27 states in all geographical regions. Foreign distribution consists of direct accounts in the following countries: Canada, China, Malaysia, Norway, Slovakia, South Korea, Sweden, Taiwan, and the United Kingdom.","F-0811-2014","Class II","Healthy Alternatives, Digestion & Stomach Upset Support, packaged 90-capsule bottles (SKU 54897). Firm name on the label is Health Enhancement, Inc. Grass Valley, CA;","Lot #'s: 54897000",,"933 bottles","Firm is recalling dietary supplements containing a raw material which may contain >0.3 ppb chloramphenicol",10/30/2013,"10/30/2013",12/18/2013,"12/18/2013"
"Food",66658,"Ongoing","National Enzyme Co","Forsyth","MO","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Domestic distribution of the product is nationwide with direct accounts in 27 states in all geographical regions. Foreign distribution consists of direct accounts in the following countries: Canada, China, Malaysia, Norway, Slovakia, South Korea, Sweden, Taiwan, and the United Kingdom.","F-0748-2014","Class II","NWC Naturals, Daily Cal, packaged in 200-capsule bottles (SKU 53343). Manufactured exclusively for Natural Wellness Centers of American, Inc. Laguna Hills, CA.;","Lot #: 53343006",,"417 bottles","Firm is recalling dietary supplements containing a raw material which may contain >0.3 ppb chloramphenicol",10/30/2013,"10/30/2013",12/18/2013,"12/18/2013"
"Food",66658,"Ongoing","National Enzyme Co","Forsyth","MO","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Domestic distribution of the product is nationwide with direct accounts in 27 states in all geographical regions. Foreign distribution consists of direct accounts in the following countries: Canada, China, Malaysia, Norway, Slovakia, South Korea, Sweden, Taiwan, and the United Kingdom.","F-0805-2014","Class II","Healthy Reflections, Colon Health Support, packaged 120-capsule bottles (SKU 54554). Firm name on the label is Healthy Reflections, Garfield, MN; ","Lot #: 54554000",,"852 bottles","Firm is recalling dietary supplements containing a raw material which may contain >0.3 ppb chloramphenicol",10/30/2013,"10/30/2013",12/18/2013,"12/18/2013"
"Food",66658,"Ongoing","National Enzyme Co","Forsyth","MO","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Domestic distribution of the product is nationwide with direct accounts in 27 states in all geographical regions. Foreign distribution consists of direct accounts in the following countries: Canada, China, Malaysia, Norway, Slovakia, South Korea, Sweden, Taiwan, and the United Kingdom.","F-0761-2014","Class II","Bulk 9245 YOGIHOUSE DIGESTIVE BUL powder, packaged in poly bags within corrugated containers (SKU 82993);","Lot #'s: 82993011, 82993012, and 82993013",,"156.2 kg of powder","Firm is recalling dietary supplements containing a raw material which may contain >0.3 ppb chloramphenicol",10/30/2013,"10/30/2013",12/18/2013,"12/18/2013"
"Food",66658,"Ongoing","National Enzyme Co","Forsyth","MO","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Domestic distribution of the product is nationwide with direct accounts in 27 states in all geographical regions. Foreign distribution consists of direct accounts in the following countries: Canada, China, Malaysia, Norway, Slovakia, South Korea, Sweden, Taiwan, and the United Kingdom.","F-0760-2014","Class II","Northern Nutrition, Pro-3-Zyme, packaged in 180-capsule bottles (SKU 53373). Firm name on the label is Northern Nutrition, LLC, Shipshewana, IN;","Lot #: 53373006",,"598 bottles","Firm is recalling dietary supplements containing a raw material which may contain >0.3 ppb chloramphenicol",10/30/2013,"10/30/2013",12/18/2013,"12/18/2013"
"Food",66658,"Ongoing","National Enzyme Co","Forsyth","MO","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Domestic distribution of the product is nationwide with direct accounts in 27 states in all geographical regions. Foreign distribution consists of direct accounts in the following countries: Canada, China, Malaysia, Norway, Slovakia, South Korea, Sweden, Taiwan, and the United Kingdom.","F-0759-2014","Class II","Dietary Supplements packaged in the following configurations: (1) Natural Health Industries, Opti-Zyme HP, packaged in 90-capsule bottles (SKU 54654). Firm name on the label is Natural Health Industries, Clarmonte, CA; (2) 8974 Enzymes Inc Natural Hea, packaged in unlabeled, 90-capsule bottles (SKU 54756);","Lot #'s: 54654001 and 54756000",,"997 bottles.","Firm is recalling dietary supplements containing a raw material which may contain >0.3 ppb chloramphenicol",10/30/2013,"10/30/2013",12/18/2013,"12/18/2013"
"Food",66658,"Ongoing","National Enzyme Co","Forsyth","MO","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Domestic distribution of the product is nationwide with direct accounts in 27 states in all geographical regions. Foreign distribution consists of direct accounts in the following countries: Canada, China, Malaysia, Norway, Slovakia, South Korea, Sweden, Taiwan, and the United Kingdom.","F-0746-2014","Class II","Dietary Supplement packaged in the following configurations: (1) 5357 NWC UltraEnzSup 90' packaged in 90 count capsule unlabeled bottles (SKU 50027); (2) 5357 NWC UltraEnzSup UNL 200 packaged in 200 count capsule unlabeled bottles (SKU 50028); (3) NWC Naturals Ultra Enzyme Support packaged in 200-(SKU 52466) and 90-(SKU 52467) count capsule bottles. Manufactured exclusively for Natural Wellness Centers of America, Laguna Hills, CA.","Lot #'s: 50027001, 50028001, 52466045, 52466046, 52466047, 52466048, 52466049, 52466050, 52466052, 52467041, 52467042, 52467043, 52467044, and 52467046",,"4,438 bottles","Firm is recalling dietary supplements containing a raw material which may contain >0.3 ppb chloramphenicol",10/30/2013,"10/30/2013",12/18/2013,"12/18/2013"
"Food",66658,"Ongoing","National Enzyme Co","Forsyth","MO","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Domestic distribution of the product is nationwide with direct accounts in 27 states in all geographical regions. Foreign distribution consists of direct accounts in the following countries: Canada, China, Malaysia, Norway, Slovakia, South Korea, Sweden, Taiwan, and the United Kingdom.","F-0767-2014","Class II","Bulk 9730 BIOSANLABS GLUTENEZYME capsules, packaged in poly bags in corrugated boxes (for domestic distribution) or fiber drums (for international distribution) (SKU 92103).","Lot #'s: 92103002, 92103004, 92103005, 92103006, 92103007, and 92103008",,"835,013 bulk capsules","Firm is recalling dietary supplements containing a raw material which may contain >0.3 ppb chloramphenicol",10/30/2013,"10/30/2013",12/18/2013,"12/18/2013"
"Food",66658,"Ongoing","National Enzyme Co","Forsyth","MO","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Domestic distribution of the product is nationwide with direct accounts in 27 states in all geographical regions. Foreign distribution consists of direct accounts in the following countries: Canada, China, Malaysia, Norway, Slovakia, South Korea, Sweden, Taiwan, and the United Kingdom.","F-0791-2014","Class II","Bulk B910 Houston Nutr TriEnz Bu powder, packaged in varying quantities within poly bags within corrugated boxes (for domestic distribution) or fiber drums (for international distribution) (SKU 83381);","Lot #: 83381000",,"25.75 kg of powder","Firm is recalling dietary supplements containing a raw material which may contain >0.3 ppb chloramphenicol",10/30/2013,"10/30/2013",12/18/2013,"12/18/2013"
"Food",66658,"Ongoing","National Enzyme Co","Forsyth","MO","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Domestic distribution of the product is nationwide with direct accounts in 27 states in all geographical regions. Foreign distribution consists of direct accounts in the following countries: Canada, China, Malaysia, Norway, Slovakia, South Korea, Sweden, Taiwan, and the United Kingdom.","F-0786-2014","Class II","Bulk B199 Reviva Digestion Bulk powder, packaged in varying quantities within poly bags within corrugated boxes (for domestic distribution) or fiber drums (for international distribution) (SKU 83342).","Lot #: 83342001",,"32.23 kg of powder","Firm is recalling dietary supplements containing a raw material which may contain >0.3 ppb chloramphenicol",10/30/2013,"10/30/2013",12/18/2013,"12/18/2013"
"Food",66658,"Ongoing","National Enzyme Co","Forsyth","MO","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Domestic distribution of the product is nationwide with direct accounts in 27 states in all geographical regions. Foreign distribution consists of direct accounts in the following countries: Canada, China, Malaysia, Norway, Slovakia, South Korea, Sweden, Taiwan, and the United Kingdom.","F-0777-2014","Class II","Bulk A213 Phion Complete Digestiv capsules (SKU 92123), packaged in varying quantities within poly bags in corrugated boxes (for domestic distribution) or fiber drums (for international distribution)","Lot #: 92123004 and 92123005",,"212,381 bulk capsules.","Firm is recalling dietary supplements containing a raw material which may contain >0.3 ppb chloramphenicol",10/30/2013,"10/30/2013",12/18/2013,"12/18/2013"
"Food",66658,"Ongoing","National Enzyme Co","Forsyth","MO","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Domestic distribution of the product is nationwide with direct accounts in 27 states in all geographical regions. Foreign distribution consists of direct accounts in the following countries: Canada, China, Malaysia, Norway, Slovakia, South Korea, Sweden, Taiwan, and the United Kingdom.","F-0749-2014","Class II","WELLZYMES, Protein/Fat Digestion, Enzyme Supplement packaged in 90-capsule bottles (SKU 52643). Manufactured exclusively for enzymes, inc., Kansas City, MO.","Lot #: 52643002",,"515 bottles.","Firm is recalling dietary supplements containing a raw material which may contain >0.3 ppb chloramphenicol",10/30/2013,"10/30/2013",12/18/2013,"12/18/2013"
"Food",66658,"Ongoing","National Enzyme Co","Forsyth","MO","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Domestic distribution of the product is nationwide with direct accounts in 27 states in all geographical regions. Foreign distribution consists of direct accounts in the following countries: Canada, China, Malaysia, Norway, Slovakia, South Korea, Sweden, Taiwan, and the United Kingdom.","F-0792-2014","Class II","B911 Kirkman Max Spectrum E, packaged unlabeled, 90-capsule bottles (SKU 54255);","Lot #: 54255000",,"1138 bottles","Firm is recalling dietary supplements containing a raw material which may contain >0.3 ppb chloramphenicol",10/30/2013,"10/30/2013",12/18/2013,"12/18/2013"
"Food",66658,"Ongoing","National Enzyme Co","Forsyth","MO","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Domestic distribution of the product is nationwide with direct accounts in 27 states in all geographical regions. Foreign distribution consists of direct accounts in the following countries: Canada, China, Malaysia, Norway, Slovakia, South Korea, Sweden, Taiwan, and the United Kingdom.","F-0755-2014","Class II","Dietary Supplements packaged in the following configurations: (1) 7263 Kirk Enz-Comp-W-TG UNL, packaged in unlabeled, 90-capsule bottles (SKU 52939); (2) 7263 Kirk Enz-Comp-W-TG UNL2, packaged in unlabeled 180-capsule bottles (SKU 53852); ","Lot #'s: 52939039, 52939040, 52939042, 52939043, 53852011, 53852012, 53852013, 53852015, and 53852016",,"16444 bottles","Firm is recalling dietary supplements containing a raw material which may contain >0.3 ppb chloramphenicol",10/30/2013,"10/30/2013",12/18/2013,"12/18/2013"
"Food",66658,"Ongoing","National Enzyme Co","Forsyth","MO","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Domestic distribution of the product is nationwide with direct accounts in 27 states in all geographical regions. Foreign distribution consists of direct accounts in the following countries: Canada, China, Malaysia, Norway, Slovakia, South Korea, Sweden, Taiwan, and the United Kingdom.","F-0809-2014","Class II","Bulk C812 ZoiVi Digestive Formula powder, packaged in varying quantities within poly bags within corrugated boxes (for domestic distribution) or fiber drums (for international distribution) (SKU 83438)","Lot #: 83438000",,"77.85 kg of powder","Firm is recalling dietary supplements containing a raw material which may contain >0.3 ppb chloramphenicol",10/30/2013,"10/30/2013",12/18/2013,"12/18/2013"
"Food",66658,"Ongoing","National Enzyme Co","Forsyth","MO","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Domestic distribution of the product is nationwide with direct accounts in 27 states in all geographical regions. Foreign distribution consists of direct accounts in the following countries: Canada, China, Malaysia, Norway, Slovakia, South Korea, Sweden, Taiwan, and the United Kingdom.","F-0806-2014","Class II","Dietary Supplements packaged in the following configurations: (1) No-Fenol Chewable, Multi-Enzyme Product for Digestion of Phenolic Foods and Fibers, packaged 180-chewable tablets bottles (SKU 54651). Firm name on the label is Houston Nutraceutical Inc. (HNI), Siloam, AR; (2) Bulk C613 Houston No-Fenol Bulk powder packaged in varying quantities within poly bags within corrugated boxes (for domestic distribution) or fiber drums (for international distribution) (SKU 83451); (3) Bulk C613 Houston No-Fenol Chew T chewable tablets, packaged in varying quantities within poly bags within corrugated boxes (for domestic distribution) or fiber drums (for international distribution) (SKU 92566);","Lot #'s: 54651001, 83451000, and 92566001",,"594 bottles, 0.23 kg of powder, and 20,580 bulk capsules","Firm is recalling dietary supplements containing a raw material which may contain >0.3 ppb chloramphenicol",10/30/2013,"10/30/2013",12/18/2013,"12/18/2013"
"Food",66658,"Ongoing","National Enzyme Co","Forsyth","MO","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Domestic distribution of the product is nationwide with direct accounts in 27 states in all geographical regions. Foreign distribution consists of direct accounts in the following countries: Canada, China, Malaysia, Norway, Slovakia, South Korea, Sweden, Taiwan, and the United Kingdom.","F-0780-2014","Class II","Mountain States Health Products, Inc., Gluten & Dairy Digest, Enzyme Supplement packaged in 90-capsule bottles (SKU 53830). Firm name on the label is Mountain States Health Products, Inc., Lyons, CO;","Lot #'s: 53830001 and 53830002",,"1173 bottles","Firm is recalling dietary supplements containing a raw material which may contain >0.3 ppb chloramphenicol",10/30/2013,"10/30/2013",12/18/2013,"12/18/2013"
"Food",66658,"Ongoing","National Enzyme Co","Forsyth","MO","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Domestic distribution of the product is nationwide with direct accounts in 27 states in all geographical regions. Foreign distribution consists of direct accounts in the following countries: Canada, China, Malaysia, Norway, Slovakia, South Korea, Sweden, Taiwan, and the United Kingdom.","F-0796-2014","Class II","Bulk C012 BioSan Enzyme Blend 3 O capsules,packaged in varying quantities within poly bags within corrugated boxes (for domestic distribution) or fiber drums (for international distribution) (SKU 92438);","Lot #'s: 92438001, 92438002, 92438004, and 92438005",,"590,470 bulk capsules","Firm is recalling dietary supplements containing a raw material which may contain >0.3 ppb chloramphenicol",10/30/2013,"10/30/2013",12/18/2013,"12/18/2013"
"Food",66658,"Ongoing","National Enzyme Co","Forsyth","MO","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Domestic distribution of the product is nationwide with direct accounts in 27 states in all geographical regions. Foreign distribution consists of direct accounts in the following countries: Canada, China, Malaysia, Norway, Slovakia, South Korea, Sweden, Taiwan, and the United Kingdom.","F-0769-2014","Class II","Bulk 9835 ENZYMEDICA DIGESTBASICK capsules, packaged in poly bags in corrugated boxes (for domestic distribution) or fiber drums (for international distribution) (SKU 92085).","Lot #'s: 92085023, 92085025, 92085026, and 92085027",,"2,465,870 bulk capsules","Firm is recalling dietary supplements containing a raw material which may contain >0.3 ppb chloramphenicol",10/30/2013,"10/30/2013",12/18/2013,"12/18/2013"
"Food",66658,"Ongoing","National Enzyme Co","Forsyth","MO","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Domestic distribution of the product is nationwide with direct accounts in 27 states in all geographical regions. Foreign distribution consists of direct accounts in the following countries: Canada, China, Malaysia, Norway, Slovakia, South Korea, Sweden, Taiwan, and the United Kingdom.","F-0778-2014","Class II"," Bulk A216 MRM DPPIV DIGEST BULK powder (SKU 83217), packaged in varying quantities within poly bags in corrugated boxes (for domestic distribution) or fiber drums (for international distribution)","Lot #: 83217005 and 83217006",,"52.8 kg of powder","Firm is recalling dietary supplements containing a raw material which may contain >0.3 ppb chloramphenicol",10/30/2013,"10/30/2013",12/18/2013,"12/18/2013"
"Food",66658,"Ongoing","National Enzyme Co","Forsyth","MO","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Domestic distribution of the product is nationwide with direct accounts in 27 states in all geographical regions. Foreign distribution consists of direct accounts in the following countries: Canada, China, Malaysia, Norway, Slovakia, South Korea, Sweden, Taiwan, and the United Kingdom.","F-0742-2014","Class II","WELLZYMES, Gastric Ease, Enzyme Supplement packaged in 60-(SKU 52238) capsule bottles. Manufactured exclusively for enzymes, inc. Kansas City, MO","Lot Numbers: 52238012 and 52238013",,"1665 bottles","Firm is recalling dietary supplements containing a raw material which may contain >0.3 ppb chloramphenicol",10/30/2013,"10/30/2013",12/18/2013,"12/18/2013"
"Food",66658,"Ongoing","National Enzyme Co","Forsyth","MO","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Domestic distribution of the product is nationwide with direct accounts in 27 states in all geographical regions. Foreign distribution consists of direct accounts in the following countries: Canada, China, Malaysia, Norway, Slovakia, South Korea, Sweden, Taiwan, and the United Kingdom.","F-0766-2014","Class II","DigestEasy, Hypoallergenic Enzyme Supplement, packaged in 60-capsule bottles (SKU 53557). Firm name on the label is Master The Body, Joliet, IL","Lot #'s: 53557003 and 53557004",,"1777 bottles","Firm is recalling dietary supplements containing a raw material which may contain >0.3 ppb chloramphenicol",10/30/2013,"10/30/2013",12/18/2013,"12/18/2013"
"Food",66658,"Ongoing","National Enzyme Co","Forsyth","MO","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Domestic distribution of the product is nationwide with direct accounts in 27 states in all geographical regions. Foreign distribution consists of direct accounts in the following countries: Canada, China, Malaysia, Norway, Slovakia, South Korea, Sweden, Taiwan, and the United Kingdom.","F-0789-2014","Class II","Bulk B807 True Botanica Digestive, packaged in varying quantities within poly bags within corrugated boxes (for domestic distribution) or fiber drums (for international distribution) (SKU 83377);","Lot #: 83377001",,"25.9 kg of powder","Firm is recalling dietary supplements containing a raw material which may contain >0.3 ppb chloramphenicol",10/30/2013,"10/30/2013",12/18/2013,"12/18/2013"
"Food",66658,"Ongoing","National Enzyme Co","Forsyth","MO","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Domestic distribution of the product is nationwide with direct accounts in 27 states in all geographical regions. Foreign distribution consists of direct accounts in the following countries: Canada, China, Malaysia, Norway, Slovakia, South Korea, Sweden, Taiwan, and the United Kingdom.","F-0739-2014","Class II","Dietary Supplements packaged in the following configurations: (1)Transformation Professional Protocol Digest Enzyme Supplement, Packaged in 45-(SKU 54646), 60-(SKU 52413), 90-(SKU 52520), 120-(SKU 53098) capsule bottles. The firm name on the label is Transformation Enzyme Corp. Houston, TX; (2) 3989V TEC-TPP DIGEST UNL 60' unlabeled 60-(SKU 53571) capsule bottles; (3) Transformation Digest. Packaged in 60-(SKU 54599) capsule bottles. Russian label; (4) Anti-aging Nutrition Health Graph Professional Strength Digest Enzyme Supplement. Packaged in 120-(SKU 54752) bottles. The firm name on the label is Health Graph, Glenview, IL; (5) The Lohad Center for Anti-Aging Digest Enzyme Supplement. Packaged in 90-(SKU 54914) capsules bottles. The firm name on the label is The Lohad Center, Jacksonville, FL. (6) Bulk 3989V TPP-TEC Digest Conv Pa capsules (SKU 92494) packaged in varying quantities within poly bags within corrugated boxes (for domestic distribution) or fiber drums (for international distribution)","Lot Numbers: 52413126, 52413128, 52413129, 52413130, 52413131, 52413132, 52413133, 52413134, 52413138, 52520124, 52520126, 52520127, 52520128, 52520129, 52520130, 52520131, 52520135, 53098131, 53098133, 53098134, 53098135, 53098136, 53098137, 53098138, 53098139, 53098141, 53098145, 53571110, 53571111, 53571112, 53571116, 54599000, 54646000, 54646001, 54646005, 54752000, 54914002, 92494001, and 92494002",," 44288 bottles, 6781 bulk capsules;","Firm is recalling dietary supplements containing a raw material which may contain >0.3 ppb chloramphenicol",10/30/2013,"10/30/2013",12/18/2013,"12/18/2013"
"Food",66658,"Ongoing","National Enzyme Co","Forsyth","MO","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Domestic distribution of the product is nationwide with direct accounts in 27 states in all geographical regions. Foreign distribution consists of direct accounts in the following countries: Canada, China, Malaysia, Norway, Slovakia, South Korea, Sweden, Taiwan, and the United Kingdom.","F-0773-2014","Class II","NWC Naturals, Total-Nutrition Program, Dietary Supplement with L.E.A.D.S., packaged 270-capsule bottles (SKU 92131). Firm name on the label is Natural Wellness Centers of America, Inc., Laguna Hills, CA;","Lot #'s: 53770004 and 53770005",,"847 bottles","Firm is recalling dietary supplements containing a raw material which may contain >0.3 ppb chloramphenicol",10/30/2013,"10/30/2013",12/18/2013,"12/18/2013"
"Food",66658,"Ongoing","National Enzyme Co","Forsyth","MO","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Domestic distribution of the product is nationwide with direct accounts in 27 states in all geographical regions. Foreign distribution consists of direct accounts in the following countries: Canada, China, Malaysia, Norway, Slovakia, South Korea, Sweden, Taiwan, and the United Kingdom.","F-0810-2014","Class II","PerformanceZyme, packaged 250-capsule bottles (SKU 54825) and 120-capsule bottles (SKU 54826). Norwegian label; ","Lot #'s: 54825002 and 54826002",,"653 bottles","Firm is recalling dietary supplements containing a raw material which may contain >0.3 ppb chloramphenicol",10/30/2013,"10/30/2013",12/18/2013,"12/18/2013"
"Food",66658,"Ongoing","National Enzyme Co","Forsyth","MO","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Domestic distribution of the product is nationwide with direct accounts in 27 states in all geographical regions. Foreign distribution consists of direct accounts in the following countries: Canada, China, Malaysia, Norway, Slovakia, South Korea, Sweden, Taiwan, and the United Kingdom.","F-0807-2014","Class II","Bulk C665 powder, packaged in varying quantities within poly bags within corrugated boxes (for domestic distribution) or fiber drums (for international distribution) (SKU 7256000)","Lot #: 72456000",".","5 kg","Firm is recalling dietary supplements containing a raw material which may contain >0.3 ppb chloramphenicol",10/30/2013,"10/30/2013",12/26/2013,"12/26/2013"
"Food",66658,"Ongoing","National Enzyme Co","Forsyth","MO","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Domestic distribution of the product is nationwide with direct accounts in 27 states in all geographical regions. Foreign distribution consists of direct accounts in the following countries: Canada, China, Malaysia, Norway, Slovakia, South Korea, Sweden, Taiwan, and the United Kingdom.","F-0769-2014","Class II","Bulk 9835 ENZYMEDICA DIGESTBASICK capsules, packaged in poly bags in corrugated boxes (for domestic distribution) or fiber drums (for international distribution) (SKU 92085).","Lot #'s: 92085023, 92085025, 92085026, and 92085027",".","2,465,870 bulk capsules","Firm is recalling dietary supplements containing a raw material which may contain >0.3 ppb chloramphenicol",10/30/2013,"10/30/2013",12/26/2013,"12/26/2013"
"Food",66658,"Ongoing","National Enzyme Co","Forsyth","MO","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Domestic distribution of the product is nationwide with direct accounts in 27 states in all geographical regions. Foreign distribution consists of direct accounts in the following countries: Canada, China, Malaysia, Norway, Slovakia, South Korea, Sweden, Taiwan, and the United Kingdom.","F-0780-2014","Class II","Mountain States Health Products, Inc., Gluten & Dairy Digest, Enzyme Supplement packaged in 90-capsule bottles (SKU 53830). Firm name on the label is Mountain States Health Products, Inc., Lyons, CO;","Lot #'s: 53830001 and 53830002",".","1173 bottles","Firm is recalling dietary supplements containing a raw material which may contain >0.3 ppb chloramphenicol",10/30/2013,"10/30/2013",12/26/2013,"12/26/2013"
"Food",66658,"Ongoing","National Enzyme Co","Forsyth","MO","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Domestic distribution of the product is nationwide with direct accounts in 27 states in all geographical regions. Foreign distribution consists of direct accounts in the following countries: Canada, China, Malaysia, Norway, Slovakia, South Korea, Sweden, Taiwan, and the United Kingdom.","F-0811-2014","Class II","Healthy Alternatives, Digestion & Stomach Upset Support, packaged 90-capsule bottles (SKU 54897). Firm name on the label is Health Enhancement, Inc. Grass Valley, CA;","Lot #'s: 54897000",".","933 bottles","Firm is recalling dietary supplements containing a raw material which may contain >0.3 ppb chloramphenicol",10/30/2013,"10/30/2013",12/26/2013,"12/26/2013"
"Food",66658,"Ongoing","National Enzyme Co","Forsyth","MO","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Domestic distribution of the product is nationwide with direct accounts in 27 states in all geographical regions. Foreign distribution consists of direct accounts in the following countries: Canada, China, Malaysia, Norway, Slovakia, South Korea, Sweden, Taiwan, and the United Kingdom.","F-0762-2014","Class II","9326 Kirkman Bacterial Bio 6, packaged in unlabeled 60-capsule bottles (SKU 53666); ","Lot #'s: 53666006, 53666007, 53666008, and 53666009",".","7053 bottles","Firm is recalling dietary supplements containing a raw material which may contain >0.3 ppb chloramphenicol",10/30/2013,"10/30/2013",12/26/2013,"12/26/2013"
"Food",66658,"Ongoing","National Enzyme Co","Forsyth","MO","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Domestic distribution of the product is nationwide with direct accounts in 27 states in all geographical regions. Foreign distribution consists of direct accounts in the following countries: Canada, China, Malaysia, Norway, Slovakia, South Korea, Sweden, Taiwan, and the United Kingdom.","F-0760-2014","Class II","Northern Nutrition, Pro-3-Zyme, packaged in 180-capsule bottles (SKU 53373). Firm name on the label is Northern Nutrition, LLC, Shipshewana, IN;","Lot #: 53373006",".","598 bottles","Firm is recalling dietary supplements containing a raw material which may contain >0.3 ppb chloramphenicol",10/30/2013,"10/30/2013",12/26/2013,"12/26/2013"
"Food",66658,"Ongoing","National Enzyme Co","Forsyth","MO","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Domestic distribution of the product is nationwide with direct accounts in 27 states in all geographical regions. Foreign distribution consists of direct accounts in the following countries: Canada, China, Malaysia, Norway, Slovakia, South Korea, Sweden, Taiwan, and the United Kingdom.","F-0757-2014","Class II","8532 Kirkman MaxEnzComp w/DP packaged in unlabeled 120-capsule bottles (SKU 53854)","Lot #'s: 53854008, 53854010, 53854012, 53854013, and 53854014",".","3642 bottles.","Firm is recalling dietary supplements containing a raw material which may contain >0.3 ppb chloramphenicol",10/30/2013,"10/30/2013",12/26/2013,"12/26/2013"
"Food",66658,"Ongoing","National Enzyme Co","Forsyth","MO","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Domestic distribution of the product is nationwide with direct accounts in 27 states in all geographical regions. Foreign distribution consists of direct accounts in the following countries: Canada, China, Malaysia, Norway, Slovakia, South Korea, Sweden, Taiwan, and the United Kingdom.","F-0745-2014","Class II","Dietary Supplements packaged in the following configurations: (1) Houston Enzymes, No-Fenol, Multi-Enzyme Product for Digestion of Phenolic Foods and Fiber packaged in 90-capsule bottles (SKU 52437). Firm name on the label is Houston Nutraceuticals, Inc. (HNI), Siloam, AR; (2) 5327 Houston NO-FENOL blk 1v, Bulk Capsules (SKU 91456)","Lot #'s: 52437042, 52437043, 52437044, 52437045, 52437046, 52437047, 52437048, 52437049, 52437050, 52437051, 52437052, 52437053, 52437054, and 91456000",".","14519 bottles and 50000 bulk capsules","Firm is recalling dietary supplements containing a raw material which may contain >0.3 ppb chloramphenicol",10/30/2013,"10/30/2013",12/26/2013,"12/26/2013"
"Food",66658,"Ongoing","National Enzyme Co","Forsyth","MO","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Domestic distribution of the product is nationwide with direct accounts in 27 states in all geographical regions. Foreign distribution consists of direct accounts in the following countries: Canada, China, Malaysia, Norway, Slovakia, South Korea, Sweden, Taiwan, and the United Kingdom.","F-0812-2014","Class II","Bulk D008 Glykon Tech Digestive B powder, packaged in varying quantities within poly bags within corrugated boxes (for domestic distribution) or fiber drums (for international distribution) (SKU 83453)","Lot #'s: 83453000",".","25.87 kg of powder","Firm is recalling dietary supplements containing a raw material which may contain >0.3 ppb chloramphenicol",10/30/2013,"10/30/2013",12/26/2013,"12/26/2013"
"Food",66658,"Ongoing","National Enzyme Co","Forsyth","MO","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Domestic distribution of the product is nationwide with direct accounts in 27 states in all geographical regions. Foreign distribution consists of direct accounts in the following countries: Canada, China, Malaysia, Norway, Slovakia, South Korea, Sweden, Taiwan, and the United Kingdom.","F-0754-2014","Class II","Dietary Supplements packaged in the following configurations: (1) 7 Lights, FULL SPECTRUM ENZYMES, packaged in 90 capsule bottles (SKU 52785). Firm name on the label is 7 Lights, Black Mountain, NC; (2) 6926 Crusador TempleBuilders, packaged in unlabeled 90 capsule bottles (SKU 54335); ","Lot #'s: 52785003 and 54335000",".","647 bottles","Firm is recalling dietary supplements containing a raw material which may contain >0.3 ppb chloramphenicol",10/30/2013,"10/30/2013",12/26/2013,"12/26/2013"
"Food",66658,"Ongoing","National Enzyme Co","Forsyth","MO","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Domestic distribution of the product is nationwide with direct accounts in 27 states in all geographical regions. Foreign distribution consists of direct accounts in the following countries: Canada, China, Malaysia, Norway, Slovakia, South Korea, Sweden, Taiwan, and the United Kingdom.","F-0801-2014","Class II","Enzyme - Travnie Extra, Formula C500, packaged in 30-capsule bottles (SKU 54513). Firm name on the label is National Enzyme Company;","Lot #: 54513000",".","5 bottles","Firm is recalling dietary supplements containing a raw material which may contain >0.3 ppb chloramphenicol",10/30/2013,"10/30/2013",12/26/2013,"12/26/2013"
"Food",66658,"Ongoing","National Enzyme Co","Forsyth","MO","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Domestic distribution of the product is nationwide with direct accounts in 27 states in all geographical regions. Foreign distribution consists of direct accounts in the following countries: Canada, China, Malaysia, Norway, Slovakia, South Korea, Sweden, Taiwan, and the United Kingdom.","F-0773-2014","Class II","NWC Naturals, Total-Nutrition Program, Dietary Supplement with L.E.A.D.S., packaged 270-capsule bottles (SKU 92131). Firm name on the label is Natural Wellness Centers of America, Inc., Laguna Hills, CA;","Lot #'s: 53770004 and 53770005",".","847 bottles","Firm is recalling dietary supplements containing a raw material which may contain >0.3 ppb chloramphenicol",10/30/2013,"10/30/2013",12/26/2013,"12/26/2013"
"Food",66658,"Ongoing","National Enzyme Co","Forsyth","MO","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Domestic distribution of the product is nationwide with direct accounts in 27 states in all geographical regions. Foreign distribution consists of direct accounts in the following countries: Canada, China, Malaysia, Norway, Slovakia, South Korea, Sweden, Taiwan, and the United Kingdom.","F-0792-2014","Class II","B911 Kirkman Max Spectrum E, packaged unlabeled, 90-capsule bottles (SKU 54255);","Lot #: 54255000",".","1138 bottles","Firm is recalling dietary supplements containing a raw material which may contain >0.3 ppb chloramphenicol",10/30/2013,"10/30/2013",12/26/2013,"12/26/2013"
"Food",66658,"Ongoing","National Enzyme Co","Forsyth","MO","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Domestic distribution of the product is nationwide with direct accounts in 27 states in all geographical regions. Foreign distribution consists of direct accounts in the following countries: Canada, China, Malaysia, Norway, Slovakia, South Korea, Sweden, Taiwan, and the United Kingdom.","F-0751-2014","Class II","Dietary Supplement packaged in the following configurations: (1) KIRKMAN Phenol Assist, packaged in 90-capsule bottles (SKU 52640). Manufactured exclusively for Kirkman, Lake Oswego, OR.; (2) 6379 Kirk Phenol Assist UNL, packaged in 90-capsule unlabeled bottles (SKU 53855)","Lot #'s: 52640015, 53855003, and 53855004",".","3455 bottles.","Firm is recalling dietary supplements containing a raw material which may contain >0.3 ppb chloramphenicol",10/30/2013,"10/30/2013",12/26/2013,"12/26/2013"
"Food",66658,"Ongoing","National Enzyme Co","Forsyth","MO","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Domestic distribution of the product is nationwide with direct accounts in 27 states in all geographical regions. Foreign distribution consists of direct accounts in the following countries: Canada, China, Malaysia, Norway, Slovakia, South Korea, Sweden, Taiwan, and the United Kingdom.","F-0806-2014","Class II","Dietary Supplements packaged in the following configurations: (1) No-Fenol Chewable, Multi-Enzyme Product for Digestion of Phenolic Foods and Fibers, packaged 180-chewable tablets bottles (SKU 54651). Firm name on the label is Houston Nutraceutical Inc. (HNI), Siloam, AR; (2) Bulk C613 Houston No-Fenol Bulk powder packaged in varying quantities within poly bags within corrugated boxes (for domestic distribution) or fiber drums (for international distribution) (SKU 83451); (3) Bulk C613 Houston No-Fenol Chew T chewable tablets, packaged in varying quantities within poly bags within corrugated boxes (for domestic distribution) or fiber drums (for international distribution) (SKU 92566);","Lot #'s: 54651001, 83451000, and 92566001",".","594 bottles, 0.23 kg of powder, and 20,580 bulk capsules","Firm is recalling dietary supplements containing a raw material which may contain >0.3 ppb chloramphenicol",10/30/2013,"10/30/2013",12/26/2013,"12/26/2013"
"Food",66658,"Ongoing","National Enzyme Co","Forsyth","MO","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Domestic distribution of the product is nationwide with direct accounts in 27 states in all geographical regions. Foreign distribution consists of direct accounts in the following countries: Canada, China, Malaysia, Norway, Slovakia, South Korea, Sweden, Taiwan, and the United Kingdom.","F-0752-2014","Class II","Dietary Supplements packaged in the following configurations: (1) Healthy Reflections, Amylase Amylolytic Enzymes Dietary Supplement, packaged in 90-capsule bottles (SKU 52896). Firm name on the label is Healthy Reflections a division of Healthy Alternatives, Garfield, MN; (2) 6895 Hlthy Alternatives Amyl, packaged in 90-capsule unlabeled bottles (SKU 54328)","Lot #'s: 52896006 and 54328000",".","1187 bottles","Firm is recalling dietary supplements containing a raw material which may contain >0.3 ppb chloramphenicol",10/30/2013,"10/30/2013",12/26/2013,"12/26/2013"
"Food",66658,"Ongoing","National Enzyme Co","Forsyth","MO","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Domestic distribution of the product is nationwide with direct accounts in 27 states in all geographical regions. Foreign distribution consists of direct accounts in the following countries: Canada, China, Malaysia, Norway, Slovakia, South Korea, Sweden, Taiwan, and the United Kingdom.","F-0735-2014","Class II","Dietary Supplement packaged in the following configuration: (1)Nutri-Essence Digestion Super Potency Enzymes & Herbs with patent-pending CereCalase Plus, packaged in 180-(SKU 51832) capsule bottles. The firm name on the label is Enzymes, Inc., Parkville, MO (2) Positive Changes Hypnosis Centers Enzymes Digestion Dietary Supplement packaged in 60-(SKU 53793) and 180-(SKU 53794) capsule bottles. The firm name on the bottle is Positive Changes Hypnosis Center Dublin, OH 43017 ","Lot Numbers: 51832027, 53793001, 53793002, 53794001, and 54426000",".","1,587 bottles","Firm is recalling dietary supplements containing a raw material which may contain >0.3 ppb chloramphenicol",10/30/2013,"10/30/2013",12/26/2013,"12/26/2013"
"Food",66658,"Ongoing","National Enzyme Co","Forsyth","MO","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Domestic distribution of the product is nationwide with direct accounts in 27 states in all geographical regions. Foreign distribution consists of direct accounts in the following countries: Canada, China, Malaysia, Norway, Slovakia, South Korea, Sweden, Taiwan, and the United Kingdom.","F-0755-2014","Class II","Dietary Supplements packaged in the following configurations: (1) 7263 Kirk Enz-Comp-W-TG UNL, packaged in unlabeled, 90-capsule bottles (SKU 52939); (2) 7263 Kirk Enz-Comp-W-TG UNL2, packaged in unlabeled 180-capsule bottles (SKU 53852); ","Lot #'s: 52939039, 52939040, 52939042, 52939043, 53852011, 53852012, 53852013, 53852015, and 53852016",".","16444 bottles","Firm is recalling dietary supplements containing a raw material which may contain >0.3 ppb chloramphenicol",10/30/2013,"10/30/2013",12/26/2013,"12/26/2013"
"Food",66658,"Ongoing","National Enzyme Co","Forsyth","MO","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Domestic distribution of the product is nationwide with direct accounts in 27 states in all geographical regions. Foreign distribution consists of direct accounts in the following countries: Canada, China, Malaysia, Norway, Slovakia, South Korea, Sweden, Taiwan, and the United Kingdom.","F-0768-2014","Class II","Bulk 9809 ENZYMEDICA CARBGESTKOSH capsules, packaged in poly bags in corrugated boxes (for domestic distribution) or fiber drums (for international distribution) (SKU 92103).","Lot #'s: 92099007",".","54,000 bulk capsules","Firm is recalling dietary supplements containing a raw material which may contain >0.3 ppb chloramphenicol",10/30/2013,"10/30/2013",12/26/2013,"12/26/2013"
"Food",66658,"Ongoing","National Enzyme Co","Forsyth","MO","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Domestic distribution of the product is nationwide with direct accounts in 27 states in all geographical regions. Foreign distribution consists of direct accounts in the following countries: Canada, China, Malaysia, Norway, Slovakia, South Korea, Sweden, Taiwan, and the United Kingdom.","F-0777-2014","Class II","Bulk A213 Phion Complete Digestiv capsules (SKU 92123), packaged in varying quantities within poly bags in corrugated boxes (for domestic distribution) or fiber drums (for international distribution)","Lot #: 92123004 and 92123005",".","212,381 bulk capsules.","Firm is recalling dietary supplements containing a raw material which may contain >0.3 ppb chloramphenicol",10/30/2013,"10/30/2013",12/26/2013,"12/26/2013"
"Food",66658,"Ongoing","National Enzyme Co","Forsyth","MO","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Domestic distribution of the product is nationwide with direct accounts in 27 states in all geographical regions. Foreign distribution consists of direct accounts in the following countries: Canada, China, Malaysia, Norway, Slovakia, South Korea, Sweden, Taiwan, and the United Kingdom.","F-0743-2014","Class II","4764 Higher Nature Supergest, Bulk Capsules, packaged in varying quantities in poly bags placed inside fiber drums for foreign export.","Lot #'s: 91397048, 91397050, 91397053, 91397054, 91397055, 91397056, and 91397057",".","1,725,998 bulk capsules","Firm is recalling dietary supplements containing a raw material which may contain >0.3 ppb chloramphenicol",10/30/2013,"10/30/2013",12/26/2013,"12/26/2013"
"Food",66658,"Ongoing","National Enzyme Co","Forsyth","MO","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Domestic distribution of the product is nationwide with direct accounts in 27 states in all geographical regions. Foreign distribution consists of direct accounts in the following countries: Canada, China, Malaysia, Norway, Slovakia, South Korea, Sweden, Taiwan, and the United Kingdom.","F-0797-2014","Class II","Bulk C184 Ace Health Enzyme Blend powder, packaged in varying quantities within poly bags within corrugated boxes (for domestic distribution) or fiber drums (for international distribution) (SKU 83403);","Lot #: 83403000",".","26.79 kg of powder","Firm is recalling dietary supplements containing a raw material which may contain >0.3 ppb chloramphenicol",10/30/2013,"10/30/2013",12/26/2013,"12/26/2013"
"Food",66658,"Ongoing","National Enzyme Co","Forsyth","MO","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Domestic distribution of the product is nationwide with direct accounts in 27 states in all geographical regions. Foreign distribution consists of direct accounts in the following countries: Canada, China, Malaysia, Norway, Slovakia, South Korea, Sweden, Taiwan, and the United Kingdom.","F-0759-2014","Class II","Dietary Supplements packaged in the following configurations: (1) Natural Health Industries, Opti-Zyme HP, packaged in 90-capsule bottles (SKU 54654). Firm name on the label is Natural Health Industries, Clarmonte, CA; (2) 8974 Enzymes Inc Natural Hea, packaged in unlabeled, 90-capsule bottles (SKU 54756);","Lot #'s: 54654001 and 54756000",".","997 bottles.","Firm is recalling dietary supplements containing a raw material which may contain >0.3 ppb chloramphenicol",10/30/2013,"10/30/2013",12/26/2013,"12/26/2013"
"Food",66658,"Ongoing","National Enzyme Co","Forsyth","MO","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Domestic distribution of the product is nationwide with direct accounts in 27 states in all geographical regions. Foreign distribution consists of direct accounts in the following countries: Canada, China, Malaysia, Norway, Slovakia, South Korea, Sweden, Taiwan, and the United Kingdom.","F-0808-2014","Class II","Bulk C676 BnG Global Digestive Blend powder, packaged in varying quantities within poly bags within corrugated boxes (for domestic distribution) or fiber drums (for international distribution) (SKU 83430)","Lot #: 83430001 and 83430002",".","108 kg of powder","Firm is recalling dietary supplements containing a raw material which may contain >0.3 ppb chloramphenicol",10/30/2013,"10/30/2013",12/26/2013,"12/26/2013"
"Food",66658,"Ongoing","National Enzyme Co","Forsyth","MO","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Domestic distribution of the product is nationwide with direct accounts in 27 states in all geographical regions. Foreign distribution consists of direct accounts in the following countries: Canada, China, Malaysia, Norway, Slovakia, South Korea, Sweden, Taiwan, and the United Kingdom.","F-0809-2014","Class II","Bulk C812 ZoiVi Digestive Formula powder, packaged in varying quantities within poly bags within corrugated boxes (for domestic distribution) or fiber drums (for international distribution) (SKU 83438)","Lot #: 83438000",".","77.85 kg of powder","Firm is recalling dietary supplements containing a raw material which may contain >0.3 ppb chloramphenicol",10/30/2013,"10/30/2013",12/26/2013,"12/26/2013"
"Food",66658,"Ongoing","National Enzyme Co","Forsyth","MO","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Domestic distribution of the product is nationwide with direct accounts in 27 states in all geographical regions. Foreign distribution consists of direct accounts in the following countries: Canada, China, Malaysia, Norway, Slovakia, South Korea, Sweden, Taiwan, and the United Kingdom.","F-0766-2014","Class II","DigestEasy, Hypoallergenic Enzyme Supplement, packaged in 60-capsule bottles (SKU 53557). Firm name on the label is Master The Body, Joliet, IL","Lot #'s: 53557003 and 53557004",".","1777 bottles","Firm is recalling dietary supplements containing a raw material which may contain >0.3 ppb chloramphenicol",10/30/2013,"10/30/2013",12/26/2013,"12/26/2013"
"Food",66658,"Ongoing","National Enzyme Co","Forsyth","MO","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Domestic distribution of the product is nationwide with direct accounts in 27 states in all geographical regions. Foreign distribution consists of direct accounts in the following countries: Canada, China, Malaysia, Norway, Slovakia, South Korea, Sweden, Taiwan, and the United Kingdom.","F-0734-2014","Class II","Houston Enzymes TriEnza with DPP IV Activity, Broad-Spectrum Enzyme Product for general Digestive Support, packaged in 90-(SKU 53379) and 180-(SKU 53380) capsule bottles. The firm name on the label is Houston Nutraceuticals, Inc. (HNI), Siloam Springs, AR (2) 9212 TRIENZA Bulk Capsules (SKU 91980) packaged in varying quantities in poly bags within corrugated containers.","Lot Numbers: 53379030, 53379031, 53379032, 53379034, 53379035, 53379036, 53379037, 53379038, 53379039, 53379040, 53379041, 53380079, 53380081, 53380083, 53380085, 53380086, 53380087, 53380088, 53380089, 53380090, 53380091, 53380092, 53380093, 53380094, 53380095, 53380096, 53380097, 53380098, 53380099, 53380100, 53380101, 53380102, 53380103, 53380104, 53380105, 53380106, 53380107, 53380108, 53380109, 53380110, 53380111, 53380113, 53380114, 91980002, 91980003, and 91980004",".","54,887 bottles, and 327,139 bulk capsules","Firm is recalling dietary supplements containing a raw material which may contain >0.3 ppb chloramphenicol",10/30/2013,"10/30/2013",12/26/2013,"12/26/2013"
"Food",66658,"Ongoing","National Enzyme Co","Forsyth","MO","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Domestic distribution of the product is nationwide with direct accounts in 27 states in all geographical regions. Foreign distribution consists of direct accounts in the following countries: Canada, China, Malaysia, Norway, Slovakia, South Korea, Sweden, Taiwan, and the United Kingdom.","F-0736-2014","Class II","ProSol Professional Solutions Fiber Digestion Enzyme Supplement, packaged in 90-(SKU 51855) capsule bottles. The firm name on the label is Enzymes, Inc., Kansas City, MO ","Lot#: 51855019",".","617 Bottles","Firm is recalling dietary supplements containing a raw material which may contain >0.3 ppb chloramphenicol",10/30/2013,"10/30/2013",12/26/2013,"12/26/2013"
"Food",66658,"Ongoing","National Enzyme Co","Forsyth","MO","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Domestic distribution of the product is nationwide with direct accounts in 27 states in all geographical regions. Foreign distribution consists of direct accounts in the following countries: Canada, China, Malaysia, Norway, Slovakia, South Korea, Sweden, Taiwan, and the United Kingdom.","F-0783-2014","Class II","Bulk A977 Wedar Digestive Blend 2 powder, packaged in varying quantities within poly bags within corrugated boxes (for domestic distribution) or fiber drums (for international distribution) (SKU 83314);","Lot #'s: 83314009, 83314010, 83314011, 83314012, 83314013, 83314014, 83314015, 83314016, 83314017, 83314018, 83314019, 83314020, 83314021, 83314022, 83314023, and 83314024",".","1850.68 kg of powder","Firm is recalling dietary supplements containing a raw material which may contain >0.3 ppb chloramphenicol",10/30/2013,"10/30/2013",12/26/2013,"12/26/2013"
"Food",66658,"Ongoing","National Enzyme Co","Forsyth","MO","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Domestic distribution of the product is nationwide with direct accounts in 27 states in all geographical regions. Foreign distribution consists of direct accounts in the following countries: Canada, China, Malaysia, Norway, Slovakia, South Korea, Sweden, Taiwan, and the United Kingdom.","F-0776-2014","Class II","Dietary Supplement Formula ID A200; Packaged in the following configuration: Bulk A200 Nutr Provider Comp Dige capsules (SKU 92132), packaged in varying quantities within poly bags in corrugated boxes (for domestic distribution) or fiber drums (for international distribution)","Lot #: 92132004",".","106,743 bulk capsules","Firm is recalling dietary supplements containing a raw material which may contain >0.3 ppb chloramphenicol",10/30/2013,"10/30/2013",12/26/2013,"12/26/2013"
"Food",66658,"Ongoing","National Enzyme Co","Forsyth","MO","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Domestic distribution of the product is nationwide with direct accounts in 27 states in all geographical regions. Foreign distribution consists of direct accounts in the following countries: Canada, China, Malaysia, Norway, Slovakia, South Korea, Sweden, Taiwan, and the United Kingdom.","F-0791-2014","Class II","Bulk B910 Houston Nutr TriEnz Bu powder, packaged in varying quantities within poly bags within corrugated boxes (for domestic distribution) or fiber drums (for international distribution) (SKU 83381);","Lot #: 83381000",".","25.75 kg of powder","Firm is recalling dietary supplements containing a raw material which may contain >0.3 ppb chloramphenicol",10/30/2013,"10/30/2013",12/26/2013,"12/26/2013"
"Food",66658,"Ongoing","National Enzyme Co","Forsyth","MO","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Domestic distribution of the product is nationwide with direct accounts in 27 states in all geographical regions. Foreign distribution consists of direct accounts in the following countries: Canada, China, Malaysia, Norway, Slovakia, South Korea, Sweden, Taiwan, and the United Kingdom.","F-0741-2014","Class II","WELLZYMES, Digestive Health, Enzyme Supplement packaged in 60-(SKU 52235) capsule bottles. Manufactured exclusively for enzymes, inc. Kansas City, MO","Lot Numbers: 52235014, 52235015, and 52235016",".","2503 bottles","Firm is recalling dietary supplements containing a raw material which may contain >0.3 ppb chloramphenicol",10/30/2013,"10/30/2013",12/26/2013,"12/26/2013"
"Food",66658,"Ongoing","National Enzyme Co","Forsyth","MO","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Domestic distribution of the product is nationwide with direct accounts in 27 states in all geographical regions. Foreign distribution consists of direct accounts in the following countries: Canada, China, Malaysia, Norway, Slovakia, South Korea, Sweden, Taiwan, and the United Kingdom.","F-0763-2014","Class II","Bulk 9399 OceanwideUSA DIGESTENZY capsules, packaged in poly bags in corrugated boxes (for domestic distribution) or fiber drums (for international distribution) (SKU 92033); ","Lot #: 92033003",".","106847 bulk capsules","Firm is recalling dietary supplements containing a raw material which may contain >0.3 ppb chloramphenicol",10/30/2013,"10/30/2013",12/26/2013,"12/26/2013"
"Food",66658,"Ongoing","National Enzyme Co","Forsyth","MO","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Domestic distribution of the product is nationwide with direct accounts in 27 states in all geographical regions. Foreign distribution consists of direct accounts in the following countries: Canada, China, Malaysia, Norway, Slovakia, South Korea, Sweden, Taiwan, and the United Kingdom.","F-0740-2014","Class II","enzyme essentials, OxiCellZyme, Enzyme Supplement with Herbs, packaged in 90-(SKU 54929) and 180-(SKU 52270) capsule bottles.","Lot Numbers: 52270018, 52270019, and 54929000",".","1260 bottles","Firm is recalling dietary supplements containing a raw material which may contain >0.3 ppb chloramphenicol",10/30/2013,"10/30/2013",12/26/2013,"12/26/2013"
"Food",66658,"Ongoing","National Enzyme Co","Forsyth","MO","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Domestic distribution of the product is nationwide with direct accounts in 27 states in all geographical regions. Foreign distribution consists of direct accounts in the following countries: Canada, China, Malaysia, Norway, Slovakia, South Korea, Sweden, Taiwan, and the United Kingdom.","F-0746-2014","Class II","Dietary Supplement packaged in the following configurations: (1) 5357 NWC UltraEnzSup 90' packaged in 90 count capsule unlabeled bottles (SKU 50027); (2) 5357 NWC UltraEnzSup UNL 200 packaged in 200 count capsule unlabeled bottles (SKU 50028); (3) NWC Naturals Ultra Enzyme Support packaged in 200-(SKU 52466) and 90-(SKU 52467) count capsule bottles. Manufactured exclusively for Natural Wellness Centers of America, Laguna Hills, CA.","Lot #'s: 50027001, 50028001, 52466045, 52466046, 52466047, 52466048, 52466049, 52466050, 52466052, 52467041, 52467042, 52467043, 52467044, and 52467046",".","4,438 bottles","Firm is recalling dietary supplements containing a raw material which may contain >0.3 ppb chloramphenicol",10/30/2013,"10/30/2013",12/26/2013,"12/26/2013"
"Food",66658,"Ongoing","National Enzyme Co","Forsyth","MO","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Domestic distribution of the product is nationwide with direct accounts in 27 states in all geographical regions. Foreign distribution consists of direct accounts in the following countries: Canada, China, Malaysia, Norway, Slovakia, South Korea, Sweden, Taiwan, and the United Kingdom.","F-0738-2014","Class II","3989 Bulk TPP TEC DIGEST powder, Transformation Enzyme Corporat, packaged in varying quantities in poly bags within corrugated containers. SKU 81814","Lot#: 81814110 and 81814111",".","103.14 Kg","Firm is recalling dietary supplements containing a raw material which may contain >0.3 ppb chloramphenicol",10/30/2013,"10/30/2013",12/26/2013,"12/26/2013"
"Food",66658,"Ongoing","National Enzyme Co","Forsyth","MO","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Domestic distribution of the product is nationwide with direct accounts in 27 states in all geographical regions. Foreign distribution consists of direct accounts in the following countries: Canada, China, Malaysia, Norway, Slovakia, South Korea, Sweden, Taiwan, and the United Kingdom.","F-0744-2014","Class II","Applied Health, Solutions for Life, Foundation Blue-Green Algae, Detoxify and Regenerate Energy and Immune Booster, Daily Essential Nutrients packaged in 90-capsule bottles (SKU 53623). Firm name on the label is Applied Health Solutions, Scottsdale, AZ.","Lot #'s: 53623003 and 53623004",".","1084 bottles.","Firm is recalling dietary supplements containing a raw material which may contain >0.3 ppb chloramphenicol",10/30/2013,"10/30/2013",12/26/2013,"12/26/2013"
"Food",66658,"Ongoing","National Enzyme Co","Forsyth","MO","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Domestic distribution of the product is nationwide with direct accounts in 27 states in all geographical regions. Foreign distribution consists of direct accounts in the following countries: Canada, China, Malaysia, Norway, Slovakia, South Korea, Sweden, Taiwan, and the United Kingdom.","F-0796-2014","Class II","Bulk C012 BioSan Enzyme Blend 3 O capsules,packaged in varying quantities within poly bags within corrugated boxes (for domestic distribution) or fiber drums (for international distribution) (SKU 92438);","Lot #'s: 92438001, 92438002, 92438004, and 92438005",".","590,470 bulk capsules","Firm is recalling dietary supplements containing a raw material which may contain >0.3 ppb chloramphenicol",10/30/2013,"10/30/2013",12/26/2013,"12/26/2013"
"Food",66658,"Ongoing","National Enzyme Co","Forsyth","MO","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Domestic distribution of the product is nationwide with direct accounts in 27 states in all geographical regions. Foreign distribution consists of direct accounts in the following countries: Canada, China, Malaysia, Norway, Slovakia, South Korea, Sweden, Taiwan, and the United Kingdom.","F-0785-2014","Class II","Dietary Supplements packaged in the following configuration: (1) NEC Healthy Pre Menopausal, Feminine Support for Active Women, packaged in 60-capsule bottles (SKU 54389). Firm name on the label is National Enzyme Company, Forsyth, MO; (2) Root 86, Healthy Pre Menopausal, Healthy Vitality In Active Women packaged in 60-capsule bottles (SKU 54632). Firm name on the label is Root 86, Ridgedale, MO;","Lot #: 53985002, 54389001, and 54632000",".","31 bottles","Firm is recalling dietary supplements containing a raw material which may contain >0.3 ppb chloramphenicol",10/30/2013,"10/30/2013",12/26/2013,"12/26/2013"
"Food",66658,"Ongoing","National Enzyme Co","Forsyth","MO","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Domestic distribution of the product is nationwide with direct accounts in 27 states in all geographical regions. Foreign distribution consists of direct accounts in the following countries: Canada, China, Malaysia, Norway, Slovakia, South Korea, Sweden, Taiwan, and the United Kingdom.","F-0772-2014","Class II","Bulk A036 Threshold Ess Enz Ultra capsules, packaged in poly bags in corrugated boxes (for domestic distribution) or fiber drums (for international distribution) (SKU 92131).","Lot #'s: 92131009 and 92131010",".","996,765 bulk capsules","Firm is recalling dietary supplements containing a raw material which may contain >0.3 ppb chloramphenicol",10/30/2013,"10/30/2013",12/26/2013,"12/26/2013"
"Food",66658,"Ongoing","National Enzyme Co","Forsyth","MO","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Domestic distribution of the product is nationwide with direct accounts in 27 states in all geographical regions. Foreign distribution consists of direct accounts in the following countries: Canada, China, Malaysia, Norway, Slovakia, South Korea, Sweden, Taiwan, and the United Kingdom.","F-0774-2014","Class II","Bulk A123 ORTHOMOLECULAR DIGESTIV powder (SKU 83202), packaged in poly bags in corrugated boxes (for domestic distribution) or fiber drums (for international distribution)","Lot #'s: 83202029, 83202031, 83202032, 83202033, 83202034, 83202035, 83202036, 83202038, 83202039, 83202040, and 83202041",".","1245.14 kg of powder","Firm is recalling dietary supplements containing a raw material which may contain >0.3 ppb chloramphenicol",10/30/2013,"10/30/2013",12/26/2013,"12/26/2013"
"Food",66658,"Ongoing","National Enzyme Co","Forsyth","MO","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Domestic distribution of the product is nationwide with direct accounts in 27 states in all geographical regions. Foreign distribution consists of direct accounts in the following countries: Canada, China, Malaysia, Norway, Slovakia, South Korea, Sweden, Taiwan, and the United Kingdom.","F-0770-2014","Class II","Bulk 9843 NOW Digest Platinum BLK capsules, packaged in poly bags in corrugated boxes (for domestic distribution) or fiber drums (for international distribution) (SKU 92101).","Lot #'s: 92101011, 92101013, and 92101014",".","3,847,856 bulk capsules","Firm is recalling dietary supplements containing a raw material which may contain >0.3 ppb chloramphenicol",10/30/2013,"10/30/2013",12/26/2013,"12/26/2013"
"Food",66658,"Ongoing","National Enzyme Co","Forsyth","MO","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Domestic distribution of the product is nationwide with direct accounts in 27 states in all geographical regions. Foreign distribution consists of direct accounts in the following countries: Canada, China, Malaysia, Norway, Slovakia, South Korea, Sweden, Taiwan, and the United Kingdom.","F-0814-2014","Class II","Dietary Supplements packaged in the following configurations: (1) Bulk Isolase-I powder packaged in varying quantities within poly bags within corrugated boxes (for domestic distribution) or fiber drums (for international distribution) (SKU 71453); (2) Bulk Bision Isolase powder packaged in varying quantities within poly bags within corrugated boxes (for domestic distribution) or fiber drums (for international distribution) (SKU 72073); (3) Bulk Isolase (Shanghai) powder packaged in varying quantities within poly bags within corrugated boxes (for domestic distribution) or fiber drums (for international distribution) (SKU 72077); (4) Bulk Isolase (Wedar) powder packaged in varying quantities within poly bags within corrugated boxes (for domestic distribution) or fiber drums (for international distribution) (SKU 72080); (5) Bulk Isolase (Nutri Sport) powder packaged in varying quantities within poly bags within corrugated boxes (for domestic distribution) or fiber drums (for international distribution) (SKU 72106);","Lot #'s: 71453155, 72073003, 72073004, 71453148, 71453138, 71453142, 71453143, 71453144, 71453137, 71453139, 71453145, 71453146, 71453147, 71453149, 71453152, 71453153, 71453156, 72106012, 72106013, 72106014, 72106015, 72106018, 72106019, 72106020, 72106021, 72106022, 72106024, 72106025, 71453141, 71453154, 72077001, 72080006, 72080007, 72080008, and 72080009",".","1827.13 kg of powder","Firm is recalling dietary supplements containing a raw material which may contain >0.3 ppb chloramphenicol",10/30/2013,"10/30/2013",12/26/2013,"12/26/2013"
"Food",66658,"Ongoing","National Enzyme Co","Forsyth","MO","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Domestic distribution of the product is nationwide with direct accounts in 27 states in all geographical regions. Foreign distribution consists of direct accounts in the following countries: Canada, China, Malaysia, Norway, Slovakia, South Korea, Sweden, Taiwan, and the United Kingdom.","F-0749-2014","Class II","WELLZYMES, Protein/Fat Digestion, Enzyme Supplement packaged in 90-capsule bottles (SKU 52643). Manufactured exclusively for enzymes, inc., Kansas City, MO.","Lot #: 52643002",".","515 bottles.","Firm is recalling dietary supplements containing a raw material which may contain >0.3 ppb chloramphenicol",10/30/2013,"10/30/2013",12/26/2013,"12/26/2013"
"Food",66658,"Ongoing","National Enzyme Co","Forsyth","MO","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Domestic distribution of the product is nationwide with direct accounts in 27 states in all geographical regions. Foreign distribution consists of direct accounts in the following countries: Canada, China, Malaysia, Norway, Slovakia, South Korea, Sweden, Taiwan, and the United Kingdom.","F-0800-2014","Class II","Bulk C434 Shanghai Enzyme Blend B powder, packaged in varying quantities within poly bags within corrugated boxes (for domestic distribution) or fiber drums (for international distribution) (SKU 83419);","Lot #: 83419000 and 83419001",".","567.04 kg of powder","Firm is recalling dietary supplements containing a raw material which may contain >0.3 ppb chloramphenicol",10/30/2013,"10/30/2013",12/26/2013,"12/26/2013"
"Food",66658,"Ongoing","National Enzyme Co","Forsyth","MO","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Domestic distribution of the product is nationwide with direct accounts in 27 states in all geographical regions. Foreign distribution consists of direct accounts in the following countries: Canada, China, Malaysia, Norway, Slovakia, South Korea, Sweden, Taiwan, and the United Kingdom.","F-0782-2014","Class II","Bulk A957 Nutra Med Digestive Bul powder, packaged in varying quantities within poly bags within corrugated boxes (for domestic distribution) or fiber drums (for international distribution) (SKU 83318);","Lot #'s: 83318002, 83318003, and 83318004",".","98.67 kg of powder","Firm is recalling dietary supplements containing a raw material which may contain >0.3 ppb chloramphenicol",10/30/2013,"10/30/2013",12/26/2013,"12/26/2013"
"Food",66658,"Ongoing","National Enzyme Co","Forsyth","MO","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Domestic distribution of the product is nationwide with direct accounts in 27 states in all geographical regions. Foreign distribution consists of direct accounts in the following countries: Canada, China, Malaysia, Norway, Slovakia, South Korea, Sweden, Taiwan, and the United Kingdom.","F-0756-2014","Class II","Bulk 7775 GreenPlanet Enzymeblend Powder packaged in poly bags within fiber drums (SKU 82566)","Lot #: 82566000",".","52.96 kg of powder","Firm is recalling dietary supplements containing a raw material which may contain >0.3 ppb chloramphenicol",10/30/2013,"10/30/2013",12/26/2013,"12/26/2013"
"Food",66658,"Ongoing","National Enzyme Co","Forsyth","MO","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Domestic distribution of the product is nationwide with direct accounts in 27 states in all geographical regions. Foreign distribution consists of direct accounts in the following countries: Canada, China, Malaysia, Norway, Slovakia, South Korea, Sweden, Taiwan, and the United Kingdom.","F-0798-2014","Class II","Multi Plant Enzyme Tablets, packaged 60 tablet bottles(SKU 54451). Firm name on the label is Wedar Nutrasource Inc., Hacienda Height, CA;","Lot #: 54451002",".","5328 bottles","Firm is recalling dietary supplements containing a raw material which may contain >0.3 ppb chloramphenicol",10/30/2013,"10/30/2013",12/26/2013,"12/26/2013"
"Food",66658,"Ongoing","National Enzyme Co","Forsyth","MO","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Domestic distribution of the product is nationwide with direct accounts in 27 states in all geographical regions. Foreign distribution consists of direct accounts in the following countries: Canada, China, Malaysia, Norway, Slovakia, South Korea, Sweden, Taiwan, and the United Kingdom.","F-0810-2014","Class II","PerformanceZyme, packaged 250-capsule bottles (SKU 54825) and 120-capsule bottles (SKU 54826). Norwegian label; ","Lot #'s: 54825002 and 54826002",".","653 bottles","Firm is recalling dietary supplements containing a raw material which may contain >0.3 ppb chloramphenicol",10/30/2013,"10/30/2013",12/26/2013,"12/26/2013"
"Food",66658,"Ongoing","National Enzyme Co","Forsyth","MO","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Domestic distribution of the product is nationwide with direct accounts in 27 states in all geographical regions. Foreign distribution consists of direct accounts in the following countries: Canada, China, Malaysia, Norway, Slovakia, South Korea, Sweden, Taiwan, and the United Kingdom.","F-0805-2014","Class II","Healthy Reflections, Colon Health Support, packaged 120-capsule bottles (SKU 54554). Firm name on the label is Healthy Reflections, Garfield, MN; ","Lot #: 54554000",".","852 bottles","Firm is recalling dietary supplements containing a raw material which may contain >0.3 ppb chloramphenicol",10/30/2013,"10/30/2013",12/26/2013,"12/26/2013"
"Food",66658,"Ongoing","National Enzyme Co","Forsyth","MO","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Domestic distribution of the product is nationwide with direct accounts in 27 states in all geographical regions. Foreign distribution consists of direct accounts in the following countries: Canada, China, Malaysia, Norway, Slovakia, South Korea, Sweden, Taiwan, and the United Kingdom.","F-0803-2014","Class II","Dietary Supplements packaged in the following configurations: (1) Carbo Converter-I powder, packaged 25 gram bottles (SKU 54663). Firm name on the label is National Enzyme Company, Forsyth, MO; (2) C560 NEC Carb Converter Blen packaged in unlabeled, 25 gram bottles.","Lot #: 54663000 and 54665000",".","101 bottles","Firm is recalling dietary supplements containing a raw material which may contain >0.3 ppb chloramphenicol",10/30/2013,"10/30/2013",12/26/2013,"12/26/2013"
"Food",66658,"Ongoing","National Enzyme Co","Forsyth","MO","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Domestic distribution of the product is nationwide with direct accounts in 27 states in all geographical regions. Foreign distribution consists of direct accounts in the following countries: Canada, China, Malaysia, Norway, Slovakia, South Korea, Sweden, Taiwan, and the United Kingdom.","F-0775-2014","Class II","Bulk A164 NUTRACHOICE DIGESTIVEBL powder (SKU 83196), packaged in varying quantities within poly bags in corrugated boxes (for domestic distribution) or fiber drums (for international distribution)","Lot #'s: 83196007, 83196008, 83196009, and 83196011",".","258.3 kg of powder","Firm is recalling dietary supplements containing a raw material which may contain >0.3 ppb chloramphenicol",10/30/2013,"10/30/2013",12/26/2013,"12/26/2013"
"Food",66658,"Ongoing","National Enzyme Co","Forsyth","MO","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Domestic distribution of the product is nationwide with direct accounts in 27 states in all geographical regions. Foreign distribution consists of direct accounts in the following countries: Canada, China, Malaysia, Norway, Slovakia, South Korea, Sweden, Taiwan, and the United Kingdom.","F-0799-2014","Class II","Dietary Supplements packaged in the following configurations: (1) Heryben, Eumin Integrated Plant Enzymes, packaged 60 capsule bottles(SKU 54440). Firm name on the label is ActiFit Biotechnology, Bellevue, WA; (2) Bulk C269 Shanghai Digestive Blen capsules, packaged in varying quantities within poly bags within corrugated boxes (for domestic distribution) or fiber drums (for international distribution) (SKU 92473);","Lot #: 54440000 and 92473000",".","3640 bottles and 210,098 bulk capsules","Firm is recalling dietary supplements containing a raw material which may contain >0.3 ppb chloramphenicol",10/30/2013,"10/30/2013",12/26/2013,"12/26/2013"
"Food",66658,"Ongoing","National Enzyme Co","Forsyth","MO","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Domestic distribution of the product is nationwide with direct accounts in 27 states in all geographical regions. Foreign distribution consists of direct accounts in the following countries: Canada, China, Malaysia, Norway, Slovakia, South Korea, Sweden, Taiwan, and the United Kingdom.","F-0767-2014","Class II","Bulk 9730 BIOSANLABS GLUTENEZYME capsules, packaged in poly bags in corrugated boxes (for domestic distribution) or fiber drums (for international distribution) (SKU 92103).","Lot #'s: 92103002, 92103004, 92103005, 92103006, 92103007, and 92103008",".","835,013 bulk capsules","Firm is recalling dietary supplements containing a raw material which may contain >0.3 ppb chloramphenicol",10/30/2013,"10/30/2013",12/26/2013,"12/26/2013"
"Food",66658,"Ongoing","National Enzyme Co","Forsyth","MO","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Domestic distribution of the product is nationwide with direct accounts in 27 states in all geographical regions. Foreign distribution consists of direct accounts in the following countries: Canada, China, Malaysia, Norway, Slovakia, South Korea, Sweden, Taiwan, and the United Kingdom.","F-0794-2014","Class II","IMTWellnes, Legume Digest 2.0, packaged 120-capsule bottles (SKU 54179). Firm name on the label is ANAT, LLC, Bloomfield, CT;","Lot #'s: 54179002, 54179003, and 54179004",".","2567 bottles","Firm is recalling dietary supplements containing a raw material which may contain >0.3 ppb chloramphenicol",10/30/2013,"10/30/2013",12/26/2013,"12/26/2013"
"Food",66658,"Ongoing","National Enzyme Co","Forsyth","MO","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Domestic distribution of the product is nationwide with direct accounts in 27 states in all geographical regions. Foreign distribution consists of direct accounts in the following countries: Canada, China, Malaysia, Norway, Slovakia, South Korea, Sweden, Taiwan, and the United Kingdom.","F-0793-2014","Class II","Bulk B983 Vitamin Shoppe Advnaced powder, packaged in varying quantities within poly bags within corrugated boxes (for domestic distribution) or fiber drums (for international distribution) (SKU 83408);","Lot #: 83408000",".","1.41 kg of powder","Firm is recalling dietary supplements containing a raw material which may contain >0.3 ppb chloramphenicol",10/30/2013,"10/30/2013",12/26/2013,"12/26/2013"
"Food",66658,"Ongoing","National Enzyme Co","Forsyth","MO","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Domestic distribution of the product is nationwide with direct accounts in 27 states in all geographical regions. Foreign distribution consists of direct accounts in the following countries: Canada, China, Malaysia, Norway, Slovakia, South Korea, Sweden, Taiwan, and the United Kingdom.","F-0790-2014","Class II","Dietary Supplement Formula ID B859; Packaged in the following configuration: B859 Kirkman Enz Comp DPP-IV, packaged in unlabeled, 90-count bottles (SKU 54112);","Lot #: 54112001",".","1155 bottles","Firm is recalling dietary supplements containing a raw material which may contain >0.3 ppb chloramphenicol",10/30/2013,"10/30/2013",12/26/2013,"12/26/2013"
"Food",66658,"Ongoing","National Enzyme Co","Forsyth","MO","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Domestic distribution of the product is nationwide with direct accounts in 27 states in all geographical regions. Foreign distribution consists of direct accounts in the following countries: Canada, China, Malaysia, Norway, Slovakia, South Korea, Sweden, Taiwan, and the United Kingdom.","F-0789-2014","Class II","Bulk B807 True Botanica Digestive, packaged in varying quantities within poly bags within corrugated boxes (for domestic distribution) or fiber drums (for international distribution) (SKU 83377);","Lot #: 83377001",".","25.9 kg of powder","Firm is recalling dietary supplements containing a raw material which may contain >0.3 ppb chloramphenicol",10/30/2013,"10/30/2013",12/26/2013,"12/26/2013"
"Food",66658,"Ongoing","National Enzyme Co","Forsyth","MO","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Domestic distribution of the product is nationwide with direct accounts in 27 states in all geographical regions. Foreign distribution consists of direct accounts in the following countries: Canada, China, Malaysia, Norway, Slovakia, South Korea, Sweden, Taiwan, and the United Kingdom.","F-0779-2014","Class II","Bulk A322 Houston Chewable Enzyme powder (SKU 83226), packaged in varying quantities within poly bags in corrugated boxes (for domestic distribution) or fiber drums (for international distribution)","Lot #'s: 83226010, 83226011, 83226012, 83226013, 83226014, and 83226015",".","287.21 kg of powder.","Firm is recalling dietary supplements containing a raw material which may contain >0.3 ppb chloramphenicol",10/30/2013,"10/30/2013",12/26/2013,"12/26/2013"
"Food",66658,"Ongoing","National Enzyme Co","Forsyth","MO","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Domestic distribution of the product is nationwide with direct accounts in 27 states in all geographical regions. Foreign distribution consists of direct accounts in the following countries: Canada, China, Malaysia, Norway, Slovakia, South Korea, Sweden, Taiwan, and the United Kingdom.","F-0804-2014","Class II","Cellulase Cellulolytic Enzymes, packaged 100-capsule bottles (SKU 54553). Firm name on the label is Healthy Reflections, Garfield, MN; ","Lot #: 54553000 and 54553001",".","1977 bottles","Firm is recalling dietary supplements containing a raw material which may contain >0.3 ppb chloramphenicol",10/30/2013,"10/30/2013",12/26/2013,"12/26/2013"
"Food",66658,"Ongoing","National Enzyme Co","Forsyth","MO","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Domestic distribution of the product is nationwide with direct accounts in 27 states in all geographical regions. Foreign distribution consists of direct accounts in the following countries: Canada, China, Malaysia, Norway, Slovakia, South Korea, Sweden, Taiwan, and the United Kingdom.","F-0795-2014","Class II","IMTWellnes, Tribulus Supreme 2.0, GI & Immune Support, packaged 60-capsule bottles (SKU 54217). Firm name on the label is ANAT, LLC, Bloomfield, CT;","Lot #: 54217002",".","1807 bottles","Firm is recalling dietary supplements containing a raw material which may contain >0.3 ppb chloramphenicol",10/30/2013,"10/30/2013",12/26/2013,"12/26/2013"
"Food",66658,"Ongoing","National Enzyme Co","Forsyth","MO","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Domestic distribution of the product is nationwide with direct accounts in 27 states in all geographical regions. Foreign distribution consists of direct accounts in the following countries: Canada, China, Malaysia, Norway, Slovakia, South Korea, Sweden, Taiwan, and the United Kingdom.","F-0742-2014","Class II","WELLZYMES, Gastric Ease, Enzyme Supplement packaged in 60-(SKU 52238) capsule bottles. Manufactured exclusively for enzymes, inc. Kansas City, MO","Lot Numbers: 52238012 and 52238013",".","1665 bottles","Firm is recalling dietary supplements containing a raw material which may contain >0.3 ppb chloramphenicol",10/30/2013,"10/30/2013",12/26/2013,"12/26/2013"
"Food",66658,"Ongoing","National Enzyme Co","Forsyth","MO","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Domestic distribution of the product is nationwide with direct accounts in 27 states in all geographical regions. Foreign distribution consists of direct accounts in the following countries: Canada, China, Malaysia, Norway, Slovakia, South Korea, Sweden, Taiwan, and the United Kingdom.","F-0786-2014","Class II","Bulk B199 Reviva Digestion Bulk powder, packaged in varying quantities within poly bags within corrugated boxes (for domestic distribution) or fiber drums (for international distribution) (SKU 83342).","Lot #: 83342001",".","32.23 kg of powder","Firm is recalling dietary supplements containing a raw material which may contain >0.3 ppb chloramphenicol",10/30/2013,"10/30/2013",12/26/2013,"12/26/2013"
"Food",66658,"Ongoing","National Enzyme Co","Forsyth","MO","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Domestic distribution of the product is nationwide with direct accounts in 27 states in all geographical regions. Foreign distribution consists of direct accounts in the following countries: Canada, China, Malaysia, Norway, Slovakia, South Korea, Sweden, Taiwan, and the United Kingdom.","F-0739-2014","Class II","Dietary Supplements packaged in the following configurations: (1)Transformation Professional Protocol Digest Enzyme Supplement, Packaged in 45-(SKU 54646), 60-(SKU 52413), 90-(SKU 52520), 120-(SKU 53098) capsule bottles. The firm name on the label is Transformation Enzyme Corp. Houston, TX; (2) 3989V TEC-TPP DIGEST UNL 60' unlabeled 60-(SKU 53571) capsule bottles; (3) Transformation Digest. Packaged in 60-(SKU 54599) capsule bottles. Russian label; (4) Anti-aging Nutrition Health Graph Professional Strength Digest Enzyme Supplement. Packaged in 120-(SKU 54752) bottles. The firm name on the label is Health Graph, Glenview, IL; (5) The Lohad Center for Anti-Aging Digest Enzyme Supplement. Packaged in 90-(SKU 54914) capsules bottles. The firm name on the label is The Lohad Center, Jacksonville, FL. (6) Bulk 3989V TPP-TEC Digest Conv Pa capsules (SKU 92494) packaged in varying quantities within poly bags within corrugated boxes (for domestic distribution) or fiber drums (for international distribution)","Lot Numbers: 52413126, 52413128, 52413129, 52413130, 52413131, 52413132, 52413133, 52413134, 52413138, 52520124, 52520126, 52520127, 52520128, 52520129, 52520130, 52520131, 52520135, 53098131, 53098133, 53098134, 53098135, 53098136, 53098137, 53098138, 53098139, 53098141, 53098145, 53571110, 53571111, 53571112, 53571116, 54599000, 54646000, 54646001, 54646005, 54752000, 54914002, 92494001, and 92494002","."," 44288 bottles, 6781 bulk capsules;","Firm is recalling dietary supplements containing a raw material which may contain >0.3 ppb chloramphenicol",10/30/2013,"10/30/2013",12/26/2013,"12/26/2013"
"Food",66658,"Ongoing","National Enzyme Co","Forsyth","MO","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Domestic distribution of the product is nationwide with direct accounts in 27 states in all geographical regions. Foreign distribution consists of direct accounts in the following countries: Canada, China, Malaysia, Norway, Slovakia, South Korea, Sweden, Taiwan, and the United Kingdom.","F-0753-2014","Class II","Dietary Supplements packaged in the following configurations: (1) Bulk 6916 Shanghai DigestiveBlend powder, packaged in varying quantities in poly bags within fiber drums (SKU 83274); (2) Bulk 6916 WEDAR DIGESTIVEBLEND powder, packaged in varying quantities in poly bags within fiber drums (SKU 82426); ","Lot #'s: 83274014, 83274015, 83274016, 83274017, 83274018, 83274019, 83274020, 83274021, 83274022, 83274023, 83274025, 83274026, 83274027, 83274028, 83274035, 82426059, and 82426060",".","6657.39 kg of powder","Firm is recalling dietary supplements containing a raw material which may contain >0.3 ppb chloramphenicol",10/30/2013,"10/30/2013",12/26/2013,"12/26/2013"
"Food",66658,"Ongoing","National Enzyme Co","Forsyth","MO","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Domestic distribution of the product is nationwide with direct accounts in 27 states in all geographical regions. Foreign distribution consists of direct accounts in the following countries: Canada, China, Malaysia, Norway, Slovakia, South Korea, Sweden, Taiwan, and the United Kingdom.","F-0784-2014","Class II","Dietary Supplements packaged in the following configuration: (1) Competitive Nutrition, Healthy Digest, packaged in 90-capsule bottles (SKU 83314). Firm name on the label is Competitive Nutrition, Monaca, PA; (2) New Earthlings Nutritionals, Healthy Digest, Complete Digestive Enzyme Formula packaged in 90-capsule bottles (SKU 54626). Firm name on the label is Guest Chiropractic Clinic, Inman, SC; (3) Doctor Faz, Healthy Digest, Complete Digestive Enzyme Formula, packaged in 90-capsule bottles (SKU 54555). Firm name on the bottle is National Enzyme Company, Forsyth, MO; (4) Healthy Digest, Complete Digestive Enzyme Formula, packaged in 90-capsule bottles (SKU 54784). Firm name on the bottle is Natural Solutions 101, Walnut Shade, MO; (5) NEC, Healthy Digest, Full Spectrum Digestion, packaged in 90-capsule bottles (SKU 54169). Firm name on the label is National Enzyme Company, Forsyth, MO; (6) Solutions Rx, DIGESTIVE WELLNESS, COMPLETE DIGESTIVE ENZYME FORMULA, packaged in 90-capsule bottles (SKU 54608). Firm name on the bottle is Pharmacy & Healthcare Solutions, Saltillo, MS; (7) The Essentials, Ultra Professional, Digestive Essentials, Complete Digestive Enzyme Formula, packaged in 90-capsule bottles (SKU 54512). Firm name on the label is Ask The Pharmacist, Oakmont, PA; (8) FeelIt Healthy Digest, Complete Digestive Enzyme Formula, packaged in 90-capsule bottles (SKU 54872). Firm name on the label is Victory International Group, Irvine, CA;","Lot #'s: 54770000, 54626000, 54626001, 54626002, 54555002, 54784000, 54169005, 54169006, 54608001, 54512002, 54512003, 54512004, 54512005, 54512006, 54512007, and 54872000",".","1751 bottles.","Firm is recalling dietary supplements containing a raw material which may contain >0.3 ppb chloramphenicol",10/30/2013,"10/30/2013",12/26/2013,"12/26/2013"
"Food",66658,"Ongoing","National Enzyme Co","Forsyth","MO","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Domestic distribution of the product is nationwide with direct accounts in 27 states in all geographical regions. Foreign distribution consists of direct accounts in the following countries: Canada, China, Malaysia, Norway, Slovakia, South Korea, Sweden, Taiwan, and the United Kingdom.","F-0788-2014","Class II","TriEnza Powder with DPP IV Activity, packaged 105 gram bottles (SKU 54045). Firm name on the label is Houston Nutraceuticals, Inc., (HNI), Siloam Springs, AR;","Lot #'s: 54045003, 54045005, 54045006, 54045007, and 54045008",".","2834 bottles","Firm is recalling dietary supplements containing a raw material which may contain >0.3 ppb chloramphenicol",10/30/2013,"10/30/2013",12/26/2013,"12/26/2013"
"Food",66658,"Ongoing","National Enzyme Co","Forsyth","MO","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Domestic distribution of the product is nationwide with direct accounts in 27 states in all geographical regions. Foreign distribution consists of direct accounts in the following countries: Canada, China, Malaysia, Norway, Slovakia, South Korea, Sweden, Taiwan, and the United Kingdom.","F-0813-2014","Class II","Bulk D103 Life Tree Digestive Ble powder packaged in varying quantities within poly bags within corrugated boxes (for domestic distribution) or fiber drums (for international distribution) (SKU 83466). ","Lot #'s: 83466000",".","25.86 kg of powder","Firm is recalling dietary supplements containing a raw material which may contain >0.3 ppb chloramphenicol",10/30/2013,"10/30/2013",12/26/2013,"12/26/2013"
"Food",66658,"Ongoing","National Enzyme Co","Forsyth","MO","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Domestic distribution of the product is nationwide with direct accounts in 27 states in all geographical regions. Foreign distribution consists of direct accounts in the following countries: Canada, China, Malaysia, Norway, Slovakia, South Korea, Sweden, Taiwan, and the United Kingdom.","F-0761-2014","Class II","Bulk 9245 YOGIHOUSE DIGESTIVE BUL powder, packaged in poly bags within corrugated containers (SKU 82993);","Lot #'s: 82993011, 82993012, and 82993013",".","156.2 kg of powder","Firm is recalling dietary supplements containing a raw material which may contain >0.3 ppb chloramphenicol",10/30/2013,"10/30/2013",12/26/2013,"12/26/2013"
"Food",66658,"Ongoing","National Enzyme Co","Forsyth","MO","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Domestic distribution of the product is nationwide with direct accounts in 27 states in all geographical regions. Foreign distribution consists of direct accounts in the following countries: Canada, China, Malaysia, Norway, Slovakia, South Korea, Sweden, Taiwan, and the United Kingdom.","F-0764-2014","Class II","Bulk 9414 PROTHERA CANDIDACHLOREL powder, packaged in poly bags in corrugated boxes (for domestic distribution) or fiber drums (for international distribution) (SKU 83056); ","Lot #: 83056004;",".","25.86 kg of powder","Firm is recalling dietary supplements containing a raw material which may contain >0.3 ppb chloramphenicol",10/30/2013,"10/30/2013",12/26/2013,"12/26/2013"
"Food",66658,"Ongoing","National Enzyme Co","Forsyth","MO","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Domestic distribution of the product is nationwide with direct accounts in 27 states in all geographical regions. Foreign distribution consists of direct accounts in the following countries: Canada, China, Malaysia, Norway, Slovakia, South Korea, Sweden, Taiwan, and the United Kingdom.","F-0802-2014","Class II","Bulk C542 Vitakost Low Carb Diet, packaged in varying quantities within poly bags within corrugated boxes (for domestic distribution) or fiber drums (for international distribution) (SKU 92544);","Lot #: 92544001",".","209,586 bulk capsules","Firm is recalling dietary supplements containing a raw material which may contain >0.3 ppb chloramphenicol",10/30/2013,"10/30/2013",12/26/2013,"12/26/2013"
"Food",66658,"Ongoing","National Enzyme Co","Forsyth","MO","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Domestic distribution of the product is nationwide with direct accounts in 27 states in all geographical regions. Foreign distribution consists of direct accounts in the following countries: Canada, China, Malaysia, Norway, Slovakia, South Korea, Sweden, Taiwan, and the United Kingdom.","F-0771-2014","Class II","Bulk 9896 BIOMEDICALRESEARCH DIGE capsules, packaged in poly bags in corrugated boxes (for domestic distribution) or fiber drums (for international distribution) (SKU 92115).","Lot #'s: 92115011, 92115012, 92115013, 92115014, 92115015, and 92115016",".","6,139,669 bulk capsules","Firm is recalling dietary supplements containing a raw material which may contain >0.3 ppb chloramphenicol",10/30/2013,"10/30/2013",12/26/2013,"12/26/2013"
"Food",66658,"Ongoing","National Enzyme Co","Forsyth","MO","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Domestic distribution of the product is nationwide with direct accounts in 27 states in all geographical regions. Foreign distribution consists of direct accounts in the following countries: Canada, China, Malaysia, Norway, Slovakia, South Korea, Sweden, Taiwan, and the United Kingdom.","F-0737-2014","Class II","Advanced Formula, CarbohydrEnz, packaged in 60-(SKU 52083) capsule bottles. The firm name on the label is Enzymes, Inc., Parkville, MO ","Lot#: 52083008",".","900 bottles","Firm is recalling dietary supplements containing a raw material which may contain >0.3 ppb chloramphenicol",10/30/2013,"10/30/2013",12/26/2013,"12/26/2013"
"Food",66658,"Ongoing","National Enzyme Co","Forsyth","MO","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Domestic distribution of the product is nationwide with direct accounts in 27 states in all geographical regions. Foreign distribution consists of direct accounts in the following countries: Canada, China, Malaysia, Norway, Slovakia, South Korea, Sweden, Taiwan, and the United Kingdom.","F-0765-2014","Class II","Bulk 9665 BioSan Labs Hi Potency capsules, packaged in poly bags in corrugated boxes (for domestic distribution) or fiber drums (for international distribution) (SKU 92093); ","Lot #'s: 92093010, 92093011, 92093012, 92093013, 92093014, 92093015, and 92093016",".","2,134,857 bulk capsules","Firm is recalling dietary supplements containing a raw material which may contain >0.3 ppb chloramphenicol",10/30/2013,"10/30/2013",12/26/2013,"12/26/2013"
"Food",66658,"Ongoing","National Enzyme Co","Forsyth","MO","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Domestic distribution of the product is nationwide with direct accounts in 27 states in all geographical regions. Foreign distribution consists of direct accounts in the following countries: Canada, China, Malaysia, Norway, Slovakia, South Korea, Sweden, Taiwan, and the United Kingdom.","F-0778-2014","Class II"," Bulk A216 MRM DPPIV DIGEST BULK powder (SKU 83217), packaged in varying quantities within poly bags in corrugated boxes (for domestic distribution) or fiber drums (for international distribution)","Lot #: 83217005 and 83217006",".","52.8 kg of powder","Firm is recalling dietary supplements containing a raw material which may contain >0.3 ppb chloramphenicol",10/30/2013,"10/30/2013",12/26/2013,"12/26/2013"
"Food",66658,"Ongoing","National Enzyme Co","Forsyth","MO","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Domestic distribution of the product is nationwide with direct accounts in 27 states in all geographical regions. Foreign distribution consists of direct accounts in the following countries: Canada, China, Malaysia, Norway, Slovakia, South Korea, Sweden, Taiwan, and the United Kingdom.","F-0747-2014","Class II","Dietary Supplement packaged in the following configurations: (1) KIRKMAN, Enzym-Complete / DPP-IV, Broad Spectrum Digestion Formula with Dipeptidyl Peptidase IV Analog, packaged in 60-capsule bottles (SKU 52587), 120-capsule bottles (SKU 52588), and 200-capsule bottles (SKU 53853). Manufactured exclusively for KIRKMAN, Lake Oswego, OR; (2) KIRKMAN, EnZym-Complete / DPP-IV, GF/CF Enzyme Dietary Supplement, packaged in 200-capsule bottles (SKU 54956). Manufactured exclusively for KIRKMAN, Lake Oswego, OR;","Lot #'s: 52587047, 52587048, 52587049, 52587050, 52588047, 52588048, 52588049, 52588050, 52588051, 53853006, 53853007, 53853008, 53853009, 53853010, and 54956000",".","16733 bottles","Firm is recalling dietary supplements containing a raw material which may contain >0.3 ppb chloramphenicol",10/30/2013,"10/30/2013",12/26/2013,"12/26/2013"
"Food",66658,"Ongoing","National Enzyme Co","Forsyth","MO","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Domestic distribution of the product is nationwide with direct accounts in 27 states in all geographical regions. Foreign distribution consists of direct accounts in the following countries: Canada, China, Malaysia, Norway, Slovakia, South Korea, Sweden, Taiwan, and the United Kingdom.","F-0781-2014","Class II","Bulk A776 Healthline Nutri Pet Di powder, packaged in varying quantities within poly bags within corrugated boxes (for domestic distribution) or fiber drums (for international distribution) (SKU 83287);","Lot #'s: 83287006, 83287007, 83287008, 83287009, 83287010, 83287011, and 83287012;",".","207.74 kg of powder","Firm is recalling dietary supplements containing a raw material which may contain >0.3 ppb chloramphenicol",10/30/2013,"10/30/2013",12/26/2013,"12/26/2013"
"Food",66658,"Ongoing","National Enzyme Co","Forsyth","MO","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Domestic distribution of the product is nationwide with direct accounts in 27 states in all geographical regions. Foreign distribution consists of direct accounts in the following countries: Canada, China, Malaysia, Norway, Slovakia, South Korea, Sweden, Taiwan, and the United Kingdom.","F-0748-2014","Class II","NWC Naturals, Daily Cal, packaged in 200-capsule bottles (SKU 53343). Manufactured exclusively for Natural Wellness Centers of American, Inc. Laguna Hills, CA.;","Lot #: 53343006",".","417 bottles","Firm is recalling dietary supplements containing a raw material which may contain >0.3 ppb chloramphenicol",10/30/2013,"10/30/2013",12/26/2013,"12/26/2013"
"Food",66658,"Ongoing","National Enzyme Co","Forsyth","MO","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Domestic distribution of the product is nationwide with direct accounts in 27 states in all geographical regions. Foreign distribution consists of direct accounts in the following countries: Canada, China, Malaysia, Norway, Slovakia, South Korea, Sweden, Taiwan, and the United Kingdom.","F-0787-2014","Class II","Dietary Supplements packaged in the following configurations: (1) Bulk B341 Shanghai Actizyme Tab6 tablets, packaged in varying quantities within poly bags within corrugated boxes (for domestic distribution) or fiber drums (for international distribution) (SKU 92275); (2) ActiFIT, Actizyme, Digest Miracle, packaged in 60-tablet bottles (SKU 54955). Firm name on the label is ActiFit Biotechnology Co, Bellevue, WA.","Lot #'s: 92275001, 92275003, and 54955000",".","321,893 bulk capsules, 3714 bottles.","Firm is recalling dietary supplements containing a raw material which may contain >0.3 ppb chloramphenicol",10/30/2013,"10/30/2013",12/26/2013,"12/26/2013"
"Food",66658,"Ongoing","National Enzyme Co","Forsyth","MO","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Domestic distribution of the product is nationwide with direct accounts in 27 states in all geographical regions. Foreign distribution consists of direct accounts in the following countries: Canada, China, Malaysia, Norway, Slovakia, South Korea, Sweden, Taiwan, and the United Kingdom.","F-0750-2014","Class II","Dietary Supplement packaged in the following configurations: (1) WELLZYMES, Carbohydrate Digestion, Enzyme Supplement packaged in 90-capsule bottles (SKU 52644). Manufactured exclusively for enzymes, inc., Parkville, MO.; (2) 6306 WellZymes CarboDigest U, packaged in 90-capsule, unlabeled bottles (SKU 54799);","Lot #'s 52644004 and 54799000",".","565 bottles ","Firm is recalling dietary supplements containing a raw material which may contain >0.3 ppb chloramphenicol",10/30/2013,"10/30/2013",12/26/2013,"12/26/2013"
"Food",66658,"Ongoing","National Enzyme Co","Forsyth","MO","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Domestic distribution of the product is nationwide with direct accounts in 27 states in all geographical regions. Foreign distribution consists of direct accounts in the following countries: Canada, China, Malaysia, Norway, Slovakia, South Korea, Sweden, Taiwan, and the United Kingdom.","F-0758-2014","Class II","Bulk 877 HOLISTIC DIGESTIVE MULTI packaged in poly bags within fiber drums (SKU 90461)","Lot #'s: 90461064, 90461065, 90461066, 90461067, and 90461068",".","4,572,176 capsules","Firm is recalling dietary supplements containing a raw material which may contain >0.3 ppb chloramphenicol",10/30/2013,"10/30/2013",12/26/2013,"12/26/2013"
"Devices",66659,"Ongoing","Vital Images, Inc.","Minnetonka","MN","US","Voluntary: Firm Initiated","Letter","Nationwide Distribution - all states in continental USA including DC but not OK or RI. OUS: Australia, Austria, Belgium, Brazil, Canada, China, Denmark, Finland, France, Germany, Honduras, Hong Kong, Iceland, Ireland, Italy, Korea, Netherlands, New Zealand, Norway, Pakistan, Poland, Portugal, Qatar, r Saudi Arabia, Serbia, Singapore, Slovenia, South Africa,Spain , Sweden, Switzerland, Thailand, Turkey, Ukraine.","Z-0169-2014","Class II","VitreaCore software. Versions subject to the limitation: 6.0, 6.1, 6.2, 6.3 (except 6.3.1 ), 6.4 (except 6.4.4 and 6.4.5), as well as their upgrades, and 6.5. The VitreaCore (ViTALConnect) system is a medical diagnostic software system intended to process, analyze, review, and distribute multi-dimensional digital Images acquired from a variety of imaging devices including: CT, MR, CR/DR/DX, SC, US, NM, PET, XA, and RF, etc. The VitreaCore (ViTALConnect) is not meant for primary Image Interpretation In mammography.","Serial Number 540819 5040918941 CRB1209125 540837 541722 CRB1107015 541783 CRB1211144 540638 CRB1110030 CRA1107015 541350 5060218759 3070900036 540864 CRU1302045 540935 345221 CRB1206107 CRB1108021 540970 540249 CRB1211148 CRB1105014 CRB1203085 CRB1212173 541173 3070900134 373677 541633 5080115149 540621 541631 541578 542109 5080111321 5090109540 5080109815 541808 CRU1303050 5080105909 5090102074 5060218090 541618 CRU1303046 CRB1211141 CRU1203031 CRU1209037 542118 5080111550 541541 541782 542085 CRB1305211 CRB1203095 540704 541343 540693 CRB1305217 540641 541603 540322 CRB1103012 CRB1111033 CRB1112037 CRB1203084 541902 5060218686 540651 541531 541821 541997 CRB1302196 541672 542009 CRB1201048 540644 540635 CRB1203064 541554 CRB1302179 5050913152 542224 540614 542046 5060220966 540662 CRB1212154 542197 541233 540648 542195 CRB1109023 542163 541659 541590 540487 541131 CRU1212042 542204 5080122943 5090102031 5080115270 540771 CRB1212161 541645 542020 CRB1203094 CRB1302201 3070900386 CRB1203083 541605 CRB1110028 VESADLSV120900 542087 541355 3070900596 2511 542201 5041210039 5041210179 540702 CRU1303049 CRU1303051 CRU1303047 5050311950 CRB1209126 541843 3070900218 CRB1212167 541110 CRU1212043 540795 541519 CRB1201055 CRB1206108 541289 541835 541922 CRB1201050 CRB1209133 541903 50401210047 CRB1206106 CRB1203068 CRU1211040 CRB1203093 CRB1201056 3070900239 541566 540376 540839 5050911699 5080119470 CSV1303001 542082 CRU1107013 541204 541748 CRB1209121 3070900211 542095 541767 CRA1308021 542126 540552 CRB1212168 540601 5080106980 542005 CRB1109027 CRU1112026 541324 CRB1201049 540678 CRB1302181 541414 542002 541862 3070900421 CRB1305215 540241 540466 542012 CRB1206109 79178 CRB1209139 CRB1302193 541870 5080110910 CRB1209118 541538 540872 540405 CRB1203087 542000 CRB1203067 CRB1203088 CRB1203074 CRB1203079 540415 540886 CRB1302191 542193 CRB1212175 CRB1302180 CRB1212172 CRB1212162 541875 531936 CRB1203072 CRB1306239 CRB1306221 CRU1203030 540914 542175 541956 CRU1112029 541828 CRU1103012 5090105936 542148 542141 50602180",".","598","Vital Images, Inc. has found an issue in VitreaCore software though internal testing. There is a potential for incorrect and possibly reversed image orientation for certain snapshots taken in VitreaCore software versions 6.0, 6.1, 6.2, 6.3 (except 6.3.1), 6.4 (except 6.4.4 and 6.4.5), as well as their upgrades, and 6.5.",10/21/2013,"10/21/2013",11/13/2013,"11/13/2013"
"Devices",66662,"Ongoing","Philips Medical Systems North America Inc.","Bothell","WA","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution-USA (nationwide) including the states of CT, HI, IL, IN, KY, MA, ME, MI, NC, OR, PA, TX, and WA, and the countries of Australia, Austria, Belgium, Chile, Denmark, Finland, France, Germany, India, Ireland, Republic of Korea, Latvia, Netherlands, New Caledonia, New Zealand, Norway, Poland, Portugal, Romania, Saudi Arabia, Slovakia, Spain, Sweden, Switzerland, and United Kingdom.","Z-0368-2014","Class II","EPIQ 7 Ultrasound System, Model 795200, 795201, 795202. Intended for diagnostic ultrasound imaging and fluid flow analysis.","TRACE ITEM SERIAL NUMBERS in the UNITED STATES: US713B0171, US713B0207, US813B0017, US813B0018, US813B0019, US813B0020, US813B0022, US813B0023, US813B0024, US813B0025, US813B0122, US813B0123, US813B0125, US813B0127, US813B0128, US813B0129, US813B0131, US813B0132, US813B0134, US813B0135, US813B0233, US813B0234, US813B0235, US813B0236, US813B0237, US813B0238, US813B0239, US813B0240, US813B0423, US813B0424, US813B0425, US813B0426, US813B0427, US813B0428, US813B0429, US813B0430, US813B0431, US813B0432, US813B0433, US813B0434, US913B0033, US913B0034, US913B0035, US913B0036, US913B0037, US913B0038, US913B0039, US913B0040, US913B0057, US913B0060, US913B0061, US913B0062, US913B0063, US913B0064, US913B0065, US913B0066, US913B0106, US913B0107, US913B0108, US913B0109, US913B0110, US913B0111, US913B0112, US913B0113, US913B0144, US913B0176, US913B0201, US913B0256, US913B0257, US913B0350, US913B0363, US913B0364, US913B0365, US913B0366, US913B0367, US913B0368, US913B0369, US913B0380, US913B0384, US913B0395, US913B0396, US913B0397, US913B0398, US913B0399, US913B0400, US913B0401, US913B0402, US913B0409, US913B0441, US913B0444, US913B0445, US913B0446, US913B0447, US913B0503, US913B0522, US913B0614, US913B0615, US913B0616, US913B0618, US913B0619, and USO13B0043. TRACE ITEM SERIAL NUMBERS INTERNATIONAL: US513B0224, US513B0387, US613B0299, US713B0149, US713B0204, US713B0205, US713B0206, US713B0208, US713B0358, US713B0532, US713B0537, US713B0573, US713B0574, US713B0575, US713B0576, US713B0577, US713B0578, US713B0579, US713B0580, US713B0581, US713B0582, US713B0583, US713B0584, US713B0586, US713B0587, US713B0588, US713B0589, US713B0590, US713B0592, US713B0593, US713B0594, US713B0595, US813B0015, US813B0016, US813B0032, US813B0037, US813B0038, US813B0039, US813B0121, US813B0151, US813B0152, US813B0153, US813B0154, US813B0155, US813B0156, US813B0157, US813B0158, US813B0159, US813B0160, US813B0161, US813B0162, US813B0163, US813B0164, US813B0183, US813B0184, US813B0185, US813B0186, US813B0187, US813B0188, US813B0189, US813B019",,"284 units total (183 international; 100 in the US).","A problem has been detected with Philips Model EPIQ 7 Ultrasound System, software version 1.0 and 1.0.1. Using the International System Date Format may result in calculation errors in Gestational Age Gestational Age (GA) and Established Due Date (EDD).",10/17/2013,"10/17/2013",11/27/2013,"11/27/2013"
"Devices",66663,"Ongoing","Alere San Diego, Inc.","San Diego","CA","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution: USA (nationwide) and Internationally to Canada.","Z-0379-2014","Class III","Product Brand Name(s): Alere Cholestech LDX Lipid Profile''GLU Test Cassette, Model 10-991. Product Generic Name: Alere Cholestech LDX Lipid Profile''GLU Test Cassette. Description of the product: Lipid. Glucose panel Test cassettes. Product packaging: 10 individually pouched cassettes in a labeled kit box. Intended for the quantitative determination of total cholesterol, HDL (high-density lipoprotein) cholesterol, triglycerides, and/or glucose in whole blood, serum, and plasma.","Model Number: 10-991. Lot #320167. Expiration date, or Expected shelf life: 8/31/14. Expected shelf life: up to 12 months.",".","3,621 kits","Alere initiated a recall of Cholestech LDX Lipid Profile-GLU test cassettes, Catalog Number 10-991, Lot # 320167, becuase an incorrect lot number was printed on the outer 10 pack kit box label. The incorrect Lot # number printed was 321067.",10/23/2013,"10/23/2013",12/4/2013,"12/04/2013"
"Devices",66664,"Ongoing","Nobel Biocare Usa Llc","Yorba Linda","CA","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution - USA (nationwide) United States and Internationally to Austria, Belgium, Brazil, Canada, Croatia, Czech Republic, Denmark, Finland, France, Germany, Hong Kong, Hungary, India, Ireland, Italy, Japan, Latvia, Lithuania, Luxembourg, Mexico, Netherlands, Norway, Philippines, Poland, Portugal, Romania, Russia, South Africa, Spain, Sweden, Switzerland, Turkey, and the United Kingdom.","Z-0273-2014","Class II","Osseocare Pro Console & Set Osseocare Pro, Model 1600870-001, 1700470-001, and 1700471-001. Device Name: Osseocare Pro console & Set Osseocare Pro. Model: 1600870-001, 1700470-001, 1700471-001. Marketing status: Class I, under K092214. Device description: Software-based, electronically controlled tabletop device. In dentistry for dental surgery, endodontics and implantology.","Model Numbers: 1600870-001, 1700470-001, 1700471-001.",".","1082 (391 US)","The recall was initiated because there is a potential for malfunction of the OsseoCare Pro when used with the OseeoCare Pro iPad application software release 1.2.0.7. ",10/24/2013,"10/24/2013",11/20/2013,"11/20/2013"
"Food",66665,"Ongoing","Swanson Health Products, Inc","Fargo","ND","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","US: nationwide. OUS: Australia,,Taiwan, England, Portugal, Denmark, Hong Kong, Bahrain, Thailand, Ireland, France, Poland, Macedonia, Brunei, United Arab Emirates, Israel, Japan.","F-0220-2014","Class III","Swanson, Premium Brand, Full Spectrum Black Cumin Seed (Nigella Sativa) Dietary Supplement capsules, 400 mg, SW1361, UPS 0 87614 11361 6.","199388, 201359 ",,"3689","Swanson Health Products is recalling two lots of Swanson Premium Full Spectrum Black Cumin Seed (Nigella sativa) Dietary Supplement Capsules. The product was found to be mislabel. Bottles of Black Cumin Seed from these two lots numbers (199399 & 201359) have been found to contain White Cumin Seed (Cuminum cyminum). ",9/26/2013,"09/26/2013",11/27/2013,"11/27/2013"
"Devices",66666,"Ongoing","Synthes USA HQ, Inc.","West Chester","PA","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution - USA (nationwide) and internationally to Canada.","Z-0390-2014","Class II","3.7mm and 5.0mm Dynamic Locking Screw (DLS) Product Usage: 3.7mm and 5.0mm Dynamic Locking Screw (DLS) in combination with Synthes Locking Compression Plates (LCP) are intended for use in long bone fractures, the fixation of osteopenic bone, the fixation of osteotomies, and for the fixation of non-unions and malunions.","All lots of parts 09.213.022S - 09.213.070S, and 09.223.032S- 09.223.090S.",".","40248","All lots of 3.7mm and 5.0mm Dynamic Locking Screw (DLS) were recalled due to complaints of breakages at the distal tip of the pin identified after successful healing and during planned removal of the device.",7/22/2013,"07/22/2013",12/4/2013,"12/04/2013"
"Biologics",66667,"Terminated","Blood Systems Inc ","Scottsdale","AZ","US","Voluntary: Firm Initiated","Telephone","Arizona","B-0210-14","Class II","Platelets Pheresis Leukocytes Reduced Irradiated","W041013134727J (2 units)",".","2 units","Blood products, which were labeled as leukoreduced, but were not tested to verify white blood cell count, were distributed.",9/14/2013,"09/14/2013",12/26/2013,"12/26/2013"
"Devices",66670,"Ongoing","Terumo Cardiovascular Systems Corporation","Ann Arbor","MI","US","Voluntary: Firm Initiated","Telephone","US Distribution in the states of: NC and CA.","Z-0336-2014","Class II","Vascutek Gelsoft Vascular Graft (peripheral) Labeling reads in part, ''***Gelsoft Gelatin Impregnated Knitted Vascular Prosthesis***STRAIGHT***STERILE***EO***Item No: 631508***Diameter 8mm***Usable Length 15cm***Manufactured By***VASCUTEK Ltd. a TERUMO Company Newmains Avenue Inchinnan, Renfrewshire PA4 9RR Scotland***'' The Vascutek Gelsoft Vascular Prosthesis is a gelatin-sealed, woven polyester graft indicated for abdominal and peripheral vascular repair, i.e. replacement or bypass in aneurysmal and occlusive disease of arteries","Catalog Number 631508 Serial Numbers: 0001765391, 0001765392, 0001765393, 0001765394, 0001765395, 0001765396, 0001765397, 0001765398, 0001765399",,"9","Terumo Cardiovascular Systems (Terumo CVS) became aware of a customer complaint that a 15mm x 8mm Gelsoft graft was received which the customer believed was a 15mm x 6mm Gelsoft graft unit. The manufacturer confirmed a batch of product code 631508 was incorrectly labeled.",10/23/2013,"10/23/2013",11/27/2013,"11/27/2013"
"Drugs",66672,"Ongoing","Teva Pharmaceuticals USA","Horsham","PA","US","Voluntary: Firm Initiated","Letter","Nationwide","D-001-2014","Class II","Copaxone (glatiramer acetate injection), 20 mg/1 mL, 1 mL pre-filled syringe, packaged in 30 single-use PRE-FILLED Syringes and 33 Alcohol Preps (Swabs) per carton, Rx only, Marketed by: Teva Neuroscience, Inc., Kansas City, MO 64131; Distributed by: Teva Pharmaceuticals USA, Inc., North Wales, PA 19454, NDC 68546-317-30, UPC 3 68546 31730 4.","Lot X06381, Exp 10/14 ",,"6,803 cartons","Presence of Particulate Matter: A foreign particle found in a pre-filled syringe was reported through a consumer complaint about a pre-filled syringe. ",10/24/2013,"10/24/2013",11/27/2013,"11/27/2013"
"Veterinary",66673,"Ongoing","Ridley Block Operations, Inc.","Mankato","MN","US","Voluntary: Firm Initiated","Letter","Distribution was made to NE. There was not foreign or military distribution.","V-012-2014","Class II","Hubbard Grolean 16% B91Aureo 140+Vit A, medicated, contains Lasalocid, 91g/ton and Chlortetracycline 140 g/ton, vitamin A, vitamin D, and vitamin E, packaged in 50 lb/bags. Hubbard Feeds Inc., Mankato, MN.","Lot B00603274",,"56/50 lb-bags","The product is being recalled because a routine sample analyzed by the Nebraska Department of Agriculture was found to contain Oxytetracycline.",10/22/2013,"10/22/2013",12/18/2013,"12/18/2013"
"Devices",66674,"Terminated","Cutera, Inc.","Brisbane","CA","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution - USA (nationwide) and Internationally to Canada","Z-0427-2014","Class II","Cutera brand truSculpt infrared System (optional), Massager, Vacuum, radio frequency induced heat, Product is manufactured and distributed by Cutera, Inc., Brisbane, CA The truSculpt massage device is intended to provide a temporary reduction in the appearance of cellulite. The truSculpt infrared (optional) and RF energies are intended to provide topical heating for the purpose of elevating tissue temperature for the treatment of selected medical conditions such as relief of pain, muscle spasms, and increase in local circulation. ","Serial Numbers: TS10140 TS10052 TS10107 TS10161 TS10086 TS10136 TS10083 TS10045 TS10032 TS10075 TS10100 TS10070 TS10129 TS10049 TS10040 TS10055 TS10160 TS10046 TS10117 TS10137 TS10141 TS10080 TS10097 TS10037 TS10131 TS10138 TS10119 TS10088 TS10074 TS10114 TS10145 TS10066 TS10106 TS10155 TS10056 TS10094 TS10139 TS10022 TS10128 TS10112 TS10068 TS10124 TS10078 TS10134 TS10079 TS10002 TS10109 TS10156 TS10135 TS10110 TS10008 TS10115 TS10093 TS10146 TS10050 TS10017 TS10054 TS10029 TS10104 TS10048 TS10090 TS10062 TS10024 TS10158 TS10071 TS10035 TS10059 TS10153 TS10025 TS10087 TS10130 TS10133 TS10101 TS10103 TS10125 TS10018 TS10089 TS10023 TS10147 TS10033 TS10015 TS10014 TS10039 TS10085 ",,"451","Cutera received two adverse events associated with the edge of the electrode, when it was pressed against neck skin over the thyroid cartilage and due to the absence of adequate underlying conductive tissue, increased skin heating occurred. Both patients developed linear welts and blisters consistent with partial thickness thermal burns to the skin. ",10/16/2013,"10/16/2013",12/18/2013,"12/18/2013"
"Food",66676,"Ongoing","Flanes Lymar","Ponce","PR","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Puerto Rico only.","F-0828-2014","Class I","Tres Leches, Lymar, Peso Neto 3 oz, Ponce, Puerto Rico","none",".","2,200 units","Undeclared allergens: eggs, wheat and soy",10/29/2013,"10/29/2013",12/26/2013,"12/26/2013"
"Food",66677,"Ongoing","Garden-Fresh Foods, Inc.","Milwaukee","WI","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","CA, IL, IN, MA, MI,MN, MO, OH, PA, WI.","F-0652-2014","Class I","Our Own Cheesecake Delight , Product Code 0 11596 85066 5, 1/8 lb ","0 11596 85066 5 = 10/31/2013 - 11/18/2013 ",".","1,159,754.46 total pounds, for all varieties","Garden-Fresh Foods is recalling various ready-to-eat salads, slaw, and dip products sold under various brands and codes because they may be contaminated with Listeria monocytogenes.",10/30/2013,"10/30/2013",12/11/2013,"12/11/2013"
"Food",66677,"Ongoing","Garden-Fresh Foods, Inc.","Milwaukee","WI","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","CA, IL, IN, MA, MI,MN, MO, OH, PA, WI.","F-0645-2014","Class I","Cranberry Ambrosia, Product Code 0 11596 55091 6, 2/5lb ","0 11596 55091 6 = 11/2/2013 - 11/20/2013 ",".","1,159,754.46 total pounds, for all varieties","Garden-Fresh Foods is recalling various ready-to-eat salads, slaw, and dip products sold under various brands and codes because they may be contaminated with Listeria monocytogenes.",10/30/2013,"10/30/2013",12/11/2013,"12/11/2013"
"Food",66677,"Ongoing","Garden-Fresh Foods, Inc.","Milwaukee","WI","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","CA, IL, IN, MA, MI,MN, MO, OH, PA, WI.","F-0571-2014","Class I","Garden-Fresh Vinegar And Oil Cole Slaw, Product Code 0 11596 83000 1, 1/8 lb; Our Own Vinegar & Oil Cole Slaw, Product Code 0 11596 83002 5, 1/8 lb; ","0 11596 83000 1 =10/31/2013 - 11/20/2013; 0 11596 83002 5=10/31/2013 - 11/20/2013 ",".","1,159,754.46 total pounds, for all varieties","Garden-Fresh Foods is recalling various ready-to-eat salads, slaw, and dip products sold under various brands and codes because they may be contaminated with Listeria monocytogenes.",10/30/2013,"10/30/2013",12/11/2013,"12/11/2013"
"Food",66677,"Ongoing","Garden-Fresh Foods, Inc.","Milwaukee","WI","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","CA, IL, IN, MA, MI,MN, MO, OH, PA, WI.","F-0578-2014","Class I","Finest Traditions Creamy Country Cole Slaw, 10 733147 10140 4, 1/8 lb ","10 733147 10140 4 =11/5/2013 - 11/18/2013 ",".","1,159,754.46 total pounds, for all varieties","Garden-Fresh Foods is recalling various ready-to-eat salads, slaw, and dip products sold under various brands and codes because they may be contaminated with Listeria monocytogenes.",10/30/2013,"10/30/2013",12/11/2013,"12/11/2013"
"Food",66677,"Ongoing","Garden-Fresh Foods, Inc.","Milwaukee","WI","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","CA, IL, IN, MA, MI,MN, MO, OH, PA, WI.","F-0515-2014","Class I","Finest Traditions Sour Cream & Chive Potato Filling, Product Code 10 733147 10261 6, 1/8 lb; ","10 733147 10261 6 = 10/30/2013;",".","1,159,754.46 total pounds, for all varieties","Garden-Fresh Foods is recalling various ready-to-eat salads, slaw, and dip products sold under various brands and codes because they may be contaminated with Listeria monocytogenes.",10/30/2013,"10/30/2013",12/11/2013,"12/11/2013"
"Food",66677,"Ongoing","Garden-Fresh Foods, Inc.","Milwaukee","WI","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","CA, IL, IN, MA, MI,MN, MO, OH, PA, WI.","F-0586-2014","Class I","Garden-Fresh Kidney Bean Salad, Product Code 0 11596 52016 2, 2/5 lb "," 0 11596 52016 2 = 11/2/2013 - 11/20/2013 ",".","1,159,754.46 total pounds, for all varieties","Garden-Fresh Foods is recalling various ready-to-eat salads, slaw, and dip products sold under various brands and codes because they may be contaminated with Listeria monocytogenes.",10/30/2013,"10/30/2013",12/11/2013,"12/11/2013"
"Food",66677,"Ongoing","Garden-Fresh Foods, Inc.","Milwaukee","WI","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","CA, IL, IN, MA, MI,MN, MO, OH, PA, WI.","F-0569-2014","Class I","Garden-Fresh Reduced Fat Cole Slaw, Product Code 0 11596 53202 8, 1/5 lb Garden-Fresh Reduced Fat Cole Slaw, Product Code 0 11596 53500 5, 4/5 lb; Market Pantry Reduced Fat Cole Slaw, Product Code 0 85239 20117 6, 6/15 oz; ","0 11596 53202 8 = 11/9/2013 - 11/30/2013; 0 11596 53500 5 = 11/15/2013 - 11/30/2013; 0 85239 20117 6= 10/31/2013 - 11/3/2013; ;",".","1,159,754.46 total pounds, for all varieties","Garden-Fresh Foods is recalling various ready-to-eat salads, slaw, and dip products sold under various brands and codes because they may be contaminated with Listeria monocytogenes.",10/30/2013,"10/30/2013",12/11/2013,"12/11/2013"
"Food",66677,"Ongoing","Garden-Fresh Foods, Inc.","Milwaukee","WI","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","CA, IL, IN, MA, MI,MN, MO, OH, PA, WI.","F-0673-2014","Class I","Maggie's White Fruit Dip , Product Code 0 11596 06200 6, 6/12 oz ","0 11596 06200 6 = 10/30/2013 - 11/16/2013 ",".","1,159,754.46 total pounds, for all varieties","Garden-Fresh Foods is recalling various ready-to-eat salads, slaw, and dip products sold under various brands and codes because they may be contaminated with Listeria monocytogenes.",10/30/2013,"10/30/2013",12/11/2013,"12/11/2013"
"Food",66677,"Ongoing","Garden-Fresh Foods, Inc.","Milwaukee","WI","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","CA, IL, IN, MA, MI,MN, MO, OH, PA, WI.","F-0491-2014","Class I","Garden-Fresh Baked Potato Salad Kit , Product Code 0 11596 61071 9, 1/5.75lb.; Marsh Baked Potato Salad Kit, Product Code 0 11596 51083 5, 1/5.75 lb. ","0 11596 61071 9 = 10/30/2013 - 11/20/2013 0 11596 51083 5 = 10/30/2013 - 11/20/2013; ",".","1,159,754.46 total pounds, for all varieties","Garden-Fresh Foods is recalling various ready-to-eat salads, slaw, and dip products sold under various brands and codes because they may be contaminated with Listeria monocytogenes.",10/30/2013,"10/30/2013",12/11/2013,"12/11/2013"
"Food",66677,"Ongoing","Garden-Fresh Foods, Inc.","Milwaukee","WI","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","CA, IL, IN, MA, MI,MN, MO, OH, PA, WI.","F-0667-2014","Class I","Finest Traditions Fruit Dip ,Product Code 7 33147 10852 9, 6/11 oz ","7 33147 10852 9= 11/4/2013 - 12/13/2013 ",".","1,159,754.46 total pounds, for all varieties","Garden-Fresh Foods is recalling various ready-to-eat salads, slaw, and dip products sold under various brands and codes because they may be contaminated with Listeria monocytogenes.",10/30/2013,"10/30/2013",12/11/2013,"12/11/2013"
"Food",66677,"Ongoing","Garden-Fresh Foods, Inc.","Milwaukee","WI","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","CA, IL, IN, MA, MI,MN, MO, OH, PA, WI.","F-0627-2014","Class I","Garden-Fresh Wisconsin Cheddar & Pea Salad, Product Code 0 11596 52021 6 11/1/2013 - 11/15/2013 1/5 lb ","0 11596 52021 6 =11/1/2013 - 11/15/2013 ",".","1,159,754.46 total pounds, for all varieties","Garden-Fresh Foods is recalling various ready-to-eat salads, slaw, and dip products sold under various brands and codes because they may be contaminated with Listeria monocytogenes.",10/30/2013,"10/30/2013",12/11/2013,"12/11/2013"
"Food",66677,"Ongoing","Garden-Fresh Foods, Inc.","Milwaukee","WI","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","CA, IL, IN, MA, MI,MN, MO, OH, PA, WI.","F-0499-2014","Class I","Weis Amish Potato Salad, Product Code 0 41497 05845 7,12/16 oz; Weis Amish Potato Salad Product Code 0 41497 05901 0, 4/3 lb; Weis Amish Potato Salad Product Code 0 11596 51103 0, 2/5 lb.; Marsh Amish Potato Salad, Product Code 0 11596 51009 5, 2/5 lb; ","0 41497 05845 7 = 10/30/2013 - 11/18/2013; 0 41497 05901 0 = 10/31/2013 - 11/19/2013; 0 11596 51103 0 = 10/31/2013 - 11/19/2013.; 0 11596 51009 5 = 11/6/2013 - 11/14/2013 ",".","1,159,754.46 total pounds, for all varieties","Garden-Fresh Foods is recalling various ready-to-eat salads, slaw, and dip products sold under various brands and codes because they may be contaminated with Listeria monocytogenes.",10/30/2013,"10/30/2013",12/11/2013,"12/11/2013"
"Food",66677,"Ongoing","Garden-Fresh Foods, Inc.","Milwaukee","WI","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","CA, IL, IN, MA, MI,MN, MO, OH, PA, WI.","F-0615-2014","Class I","Garden-Fresh Layered Seafood Dip Base, Product Code 0 11596 55153 1, 1/4 lb ","0 11596 55153 1 = 11/1/2013 - 11/20/2013 ",".","1,159,754.46 total pounds, for all varieties","Garden-Fresh Foods is recalling various ready-to-eat salads, slaw, and dip products sold under various brands and codes because they may be contaminated with Listeria monocytogenes.",10/30/2013,"10/30/2013",12/11/2013,"12/11/2013"
"Food",66677,"Ongoing","Garden-Fresh Foods, Inc.","Milwaukee","WI","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","CA, IL, IN, MA, MI,MN, MO, OH, PA, WI.","F-0647-2014","Class I","Finest Traditions Strawberry Yogurt Cheese,Product Code 10 733147 11018 5, 1/5 lb ","10 733147 11018 5 = 11/4/2013 - 11/18/2013 ",".","1,159,754.46 total pounds, for all varieties","Garden-Fresh Foods is recalling various ready-to-eat salads, slaw, and dip products sold under various brands and codes because they may be contaminated with Listeria monocytogenes.",10/30/2013,"10/30/2013",12/11/2013,"12/11/2013"
"Food",66677,"Ongoing","Garden-Fresh Foods, Inc.","Milwaukee","WI","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","CA, IL, IN, MA, MI,MN, MO, OH, PA, WI.","F-0592-2014","Class I","Finest Traditions Smokey Baked Beans, 10 733147 10456 6, 4/8 lb Finest Traditions Smokey Baked Beans , 10 733147 10231 9, 1/8 lb Finest Traditions Smokey Baked Beans, 7 33147 00161 5, 6/16 oz ","10 733147 10456 6 = 10/30/2013 - 11/18/2013; 10 733147 10231 9 = 11/4/2013 - 11/20/2013; 7 33147 00161 5= 11/4/2013 - 11/18/2013",".","1,159,754.46 total pounds, for all varieties","Garden-Fresh Foods is recalling various ready-to-eat salads, slaw, and dip products sold under various brands and codes because they may be contaminated with Listeria monocytogenes.",10/30/2013,"10/30/2013",12/11/2013,"12/11/2013"
"Food",66677,"Ongoing","Garden-Fresh Foods, Inc.","Milwaukee","WI","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","CA, IL, IN, MA, MI,MN, MO, OH, PA, WI.","F-0597-2014","Class I","Garden-Fresh Premium Egg Salad,Product Code 0 11596 , 1/5 lb ","0 11596 52136 7=11/2/2013;",".","1,159,754.46 total pounds, for all varieties","Garden-Fresh Foods is recalling various ready-to-eat salads, slaw, and dip products sold under various brands and codes because they may be contaminated with Listeria monocytogenes.",10/30/2013,"10/30/2013",12/11/2013,"12/11/2013"
"Food",66677,"Ongoing","Garden-Fresh Foods, Inc.","Milwaukee","WI","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","CA, IL, IN, MA, MI,MN, MO, OH, PA, WI.","F-0594-2014","Class I","Garden-Fresh Egg Salad ,Product Code 0 11596 52022 3, 1/5 lb; Weis Egg Salad , Product Code 0 41497 05365 0 , 1/5 lb; Weis Egg Salad,Product Code 0 11596 55221 7, 1/5 lb ","0 11596 52022 3 = 10/30/2013 - 11/15/2013; 0 41497 05365 0=11/10/2013 - 11/15/2013; 0 11596 55221 7= 10/31/2013 - 11/9/2013 ",".","1,159,754.46 total pounds, for all varieties","Garden-Fresh Foods is recalling various ready-to-eat salads, slaw, and dip products sold under various brands and codes because they may be contaminated with Listeria monocytogenes.",10/30/2013,"10/30/2013",12/11/2013,"12/11/2013"
"Food",66677,"Ongoing","Garden-Fresh Foods, Inc.","Milwaukee","WI","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","CA, IL, IN, MA, MI,MN, MO, OH, PA, WI.","F-0624-2014","Class I","Garden-Fresh Tomato Mozzarella Salad Kit, Product Code 0 11596 55163 0, 1/5 lb ","0 11596 55163 0 = 11/1/2013 - 11/9/2013 ",".","1,159,754.46 total pounds, for all varieties","Garden-Fresh Foods is recalling various ready-to-eat salads, slaw, and dip products sold under various brands and codes because they may be contaminated with Listeria monocytogenes.",10/30/2013,"10/30/2013",12/11/2013,"12/11/2013"
"Food",66677,"Ongoing","Garden-Fresh Foods, Inc.","Milwaukee","WI","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","CA, IL, IN, MA, MI,MN, MO, OH, PA, WI.","F-0541-2014","Class I","Garden-Fresh Ranch Pasta Salad,Product Code 0 11596 52202 9,1/5 lb "," 0 11596 52202 9 = 11/1/2013 -11/19/2013 ; ;",".","1,159,754.46 total pounds, for all varieties","Garden-Fresh Foods is recalling various ready-to-eat salads, slaw, and dip products sold under various brands and codes because they may be contaminated with Listeria monocytogenes.",10/30/2013,"10/30/2013",12/11/2013,"12/11/2013"
"Food",66677,"Ongoing","Garden-Fresh Foods, Inc.","Milwaukee","WI","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","CA, IL, IN, MA, MI,MN, MO, OH, PA, WI.","F-0564-2014","Class I","Our Own Garden Pasta Salad, Product Code 0 11596 52153 4, 1/5 lb "," 0 11596 52153 4 = 11/12/2013 - 11/20/2013 ;",".","1,159,754.46 total pounds, for all varieties","Garden-Fresh Foods is recalling various ready-to-eat salads, slaw, and dip products sold under various brands and codes because they may be contaminated with Listeria monocytogenes.",10/30/2013,"10/30/2013",12/11/2013,"12/11/2013"
"Food",66677,"Ongoing","Garden-Fresh Foods, Inc.","Milwaukee","WI","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","CA, IL, IN, MA, MI,MN, MO, OH, PA, WI.","F-0501-2014","Class I","Finest Traditions Deluxe Potato Salad, Product Code 10 733147 10450 4, 4/8 lb; Finest Traditions Deluxe Potato Salad, Product Code 10 733147 10130 5, 1/8 lb; Finest Traditions Deluxe Potato Salad, Product Code 7 33147 00007 6, 6/16 oz; ","10 733147 10450 4 = 10/30/2013 - 11/18/2013; 10 733147 10130 5 = 11/4/2013 - 11/18/2013; 7 33147 00007 6 = 11/4/2013 - 11/20/2013; ",".","1,159,754.46 total pounds, for all varieties","Garden-Fresh Foods is recalling various ready-to-eat salads, slaw, and dip products sold under various brands and codes because they may be contaminated with Listeria monocytogenes.",10/30/2013,"10/30/2013",12/11/2013,"12/11/2013"
"Food",66677,"Ongoing","Garden-Fresh Foods, Inc.","Milwaukee","WI","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","CA, IL, IN, MA, MI,MN, MO, OH, PA, WI.","F-0546-2014","Class I","Garden-Fresh Premium Asiago Pasta Salad,Product Code 0 11596 45624 9, 1/4 lb ","0 11596 45624 9 = 10/30/2013 - 11/25/2013 ; ;",".","1,159,754.46 total pounds, for all varieties","Garden-Fresh Foods is recalling various ready-to-eat salads, slaw, and dip products sold under various brands and codes because they may be contaminated with Listeria monocytogenes.",10/30/2013,"10/30/2013",12/11/2013,"12/11/2013"
"Food",66677,"Ongoing","Garden-Fresh Foods, Inc.","Milwaukee","WI","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","CA, IL, IN, MA, MI,MN, MO, OH, PA, WI.","F-0626-2014","Class I","Garden-Fresh Pickled Beet And Onion Salad, Product Code 0 11596 52018 2, 1/5 lb "," 0 11596 52018 2 = 10/31/2013 - 11/20/2013 ",".","1,159,754.46 total pounds, for all varieties","Garden-Fresh Foods is recalling various ready-to-eat salads, slaw, and dip products sold under various brands and codes because they may be contaminated with Listeria monocytogenes.",10/30/2013,"10/30/2013",12/11/2013,"12/11/2013"
"Food",66677,"Ongoing","Garden-Fresh Foods, Inc.","Milwaukee","WI","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","CA, IL, IN, MA, MI,MN, MO, OH, PA, WI.","F-0480-2014","Class I","Garden-Fresh Red Potato And Herb Salad,Product Code 0 11596 91014 7, 10 lb.; Dairy Fresh Red Potato & Herb Salad,Product Code 0 70163 53370 7, 1/5 lb; ","0 11596 91014 7 = 11/5/2013 - 11/14/2013; 0 70163 53370 7 = 10/30/2013 - 11/19/2013; ",".","1,159,754.46 total pounds, for all varieties","Garden-Fresh Foods is recalling various ready-to-eat salads, slaw, and dip products sold under various brands and codes because they may be contaminated with Listeria monocytogenes.",10/30/2013,"10/30/2013",12/11/2013,"12/11/2013"
"Food",66677,"Ongoing","Garden-Fresh Foods, Inc.","Milwaukee","WI","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","CA, IL, IN, MA, MI,MN, MO, OH, PA, WI.","F-0603-2014","Class I","Finest Traditions Tuna Salad Spread, Product Code 10 733147 10186 2 11/4/2013 - 11/24/2013 2/4 lb Finest Traditions Tuna Salad Spread ,Product Code 7 33147 10487 3 11/2/2013 - 11/18/2013 6/12 oz Holiday Pantry Tuna Salad Spread, Product Code 10 733147 10780 2 11/4/2013 - 11/18/2013 4/8 lb ","10 733147 10186 2=11/4/2013 - 11/24/2013; 7 33147 10487 3 = 11/2/2013 - 11/18/2013; 10 733147 10780 2 = 11/4/2013 - 11/18/2013; ",".","1,159,754.46 total pounds, for all varieties","Garden-Fresh Foods is recalling various ready-to-eat salads, slaw, and dip products sold under various brands and codes because they may be contaminated with Listeria monocytogenes.",10/30/2013,"10/30/2013",12/11/2013,"12/11/2013"
"Food",66677,"Ongoing","Garden-Fresh Foods, Inc.","Milwaukee","WI","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","CA, IL, IN, MA, MI,MN, MO, OH, PA, WI.","F-0658-2014","Class I","Grandpas Crab Like Cheese Ball, Product Code 0 11596 55906 3, 1/5 lb "," 0 11596 55906 3 = 10/31/2013 - 11/15/2013 ",".","1,159,754.46 total pounds, for all varieties","Garden-Fresh Foods is recalling various ready-to-eat salads, slaw, and dip products sold under various brands and codes because they may be contaminated with Listeria monocytogenes.",10/30/2013,"10/30/2013",12/11/2013,"12/11/2013"
"Food",66677,"Ongoing","Garden-Fresh Foods, Inc.","Milwaukee","WI","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","CA, IL, IN, MA, MI,MN, MO, OH, PA, WI.","F-0629-2014","Class I","Apple Salad Base, Product Code 0 11596 25057 1,1/2.5lb; Finest Traditions Apple Salad Base, 10 733147 11020 8, 1/5 lb ","0 11596 25057 1 = 10/30/2013 - 11/20/2013; 10 733147 11020 8 = 11/4/2013 - 11/11/2013 ",".","1,159,754.46 total pounds, for all varieties","Garden-Fresh Foods is recalling various ready-to-eat salads, slaw, and dip products sold under various brands and codes because they may be contaminated with Listeria monocytogenes.",10/30/2013,"10/30/2013",12/11/2013,"12/11/2013"
"Food",66677,"Ongoing","Garden-Fresh Foods, Inc.","Milwaukee","WI","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","CA, IL, IN, MA, MI,MN, MO, OH, PA, WI.","F-0662-2014","Class I","Archer Farms Garlic Herb Cheese Dip, Product Code 0 00 85239 06186 2, 24/7 oz ","0 00 85239 06186 2 = 12/16/2013 ",".","1,159,754.46 total pounds, for all varieties","Garden-Fresh Foods is recalling various ready-to-eat salads, slaw, and dip products sold under various brands and codes because they may be contaminated with Listeria monocytogenes.",10/30/2013,"10/30/2013",12/11/2013,"12/11/2013"
"Food",66677,"Ongoing","Garden-Fresh Foods, Inc.","Milwaukee","WI","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","CA, IL, IN, MA, MI,MN, MO, OH, PA, WI.","F-0558-2014","Class I","Finest Traditions Southwest Taco Pasta Salad,Product Code 10 733147 10287 6, 1/8 lb "," 10 733147 10287 6= 10/30/2013 - 11/18/2013; ;",".","1,159,754.46 total pounds, for all varieties","Garden-Fresh Foods is recalling various ready-to-eat salads, slaw, and dip products sold under various brands and codes because they may be contaminated with Listeria monocytogenes.",10/30/2013,"10/30/2013",12/11/2013,"12/11/2013"
"Food",66677,"Ongoing","Garden-Fresh Foods, Inc.","Milwaukee","WI","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","CA, IL, IN, MA, MI,MN, MO, OH, PA, WI.","F-0617-2014","Class I","Archer Farms Smoked Salmon Dip, Product Code 0 85239 99019 3, 6/11 oz ","0 85239 99019 3- 11/4/2013 - 11/9/2013 ",".","1,159,754.46 total pounds, for all varieties","Garden-Fresh Foods is recalling various ready-to-eat salads, slaw, and dip products sold under various brands and codes because they may be contaminated with Listeria monocytogenes.",10/30/2013,"10/30/2013",12/11/2013,"12/11/2013"
"Food",66677,"Ongoing","Garden-Fresh Foods, Inc.","Milwaukee","WI","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","CA, IL, IN, MA, MI,MN, MO, OH, PA, WI.","F-0677-2014","Class I","Grandpas Roasted Corn & Black Bean Salsa, 5915 11/2/2013 - 11/20/2013 12 1/5 lb ","5915 = 11/2/2013 - 11/20/2013 ",".","1,159,754.46 total pounds, for all varieties","Garden-Fresh Foods is recalling various ready-to-eat salads, slaw, and dip products sold under various brands and codes because they may be contaminated with Listeria monocytogenes.",10/30/2013,"10/30/2013",12/11/2013,"12/11/2013"
"Food",66677,"Ongoing","Garden-Fresh Foods, Inc.","Milwaukee","WI","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","CA, IL, IN, MA, MI,MN, MO, OH, PA, WI.","F-0513-2014","Class I","Marsh Signature Potato Salad , Product Code 0 11596 51085 9, 2/5 lb; ","0 11596 51085 9 = 10/31/2013 - 11/19/2013; ;",".","1,159,754.46 total pounds, for all varieties","Garden-Fresh Foods is recalling various ready-to-eat salads, slaw, and dip products sold under various brands and codes because they may be contaminated with Listeria monocytogenes.",10/30/2013,"10/30/2013",12/11/2013,"12/11/2013"
"Food",66677,"Ongoing","Garden-Fresh Foods, Inc.","Milwaukee","WI","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","CA, IL, IN, MA, MI,MN, MO, OH, PA, WI.","F-0487-2014","Class I","Garden-Fresh American Potato Salad, Product Code 0 11596 51010 1, 2/5 lb.; Garden-Fresh American Potato Salad, Product Code 0 11596 14015 5, 12/16 oz.; Garden-Fresh American Potato Salad, Product Code 0 11596 24200 2, 7 8/2 lb. ; Garden-Fresh American Potato Salad, Product Code 0 11596 34310 5, 6/3 lb.; Garden-Fresh Large Diced American Potato Salad, Product Code 0 11596 91018 5 2/5 lb. Market Pantry American Potato Salad,Product Code 0 85239 24102 8, 4/3 lb; Market Pantry American Potato Salad, Product Code 0 85239 24107 3, 6/16 oz.; Spartan American Potato Salad, Product Code 0 11213 90320 0, 6/16 oz; . ","0 11596 51010 1 = 10/31/2013 - 11/20/2013; . 0 11596 14015 5 = 11/8/2013-11/15/2013; 0 11596 24200 2 = 11/1/2013 - 11/18/2013; 0 11596 34310 5 = 11/6/2013 -11/20/2013; 0 11596 91018 5 = 10/31/2013 - 11/8/2013; 0 85239 24102 8 = 10/30/2013; 0 85239 24107 3 = 10/30/2013; 0 11213 90320 0 = 10/30/2013 - 11/20/2013;",".","1,159,754.46 total pounds, for all varieties","Garden-Fresh Foods is recalling various ready-to-eat salads, slaw, and dip products sold under various brands and codes because they may be contaminated with Listeria monocytogenes.",10/30/2013,"10/30/2013",12/11/2013,"12/11/2013"
"Food",66677,"Ongoing","Garden-Fresh Foods, Inc.","Milwaukee","WI","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","CA, IL, IN, MA, MI,MN, MO, OH, PA, WI.","F-0516-2014","Class I","Garden-Fresh Amish Country Macaroni Salad, Product Code 0 11596 52010 0, 2/5 lb; ","11596 52010 0 = 11/1/2013 - 11/19/2013;",".","1,159,754.46 total pounds, for all varieties","Garden-Fresh Foods is recalling various ready-to-eat salads, slaw, and dip products sold under various brands and codes because they may be contaminated with Listeria monocytogenes.",10/30/2013,"10/30/2013",12/11/2013,"12/11/2013"
"Food",66677,"Ongoing","Garden-Fresh Foods, Inc.","Milwaukee","WI","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","CA, IL, IN, MA, MI,MN, MO, OH, PA, WI.","F-0527-2014","Class I","Garden-Fresh Sour Cream Mac & Cheddar,Product Code 0 11596 92031 3, 2/5 lb Dairy Fresh Sour Cream Mac & Cheddar, Product Code 0 70163 50043 3, 2/5 lb ","0 11596 92031 3 = 10/30/2013 - 11/20/2013; 0 70163 50043 3=11/12/2013 - 11/18/2013 ;",".","1,159,754.46 total pounds, for all varieties","Garden-Fresh Foods is recalling various ready-to-eat salads, slaw, and dip products sold under various brands and codes because they may be contaminated with Listeria monocytogenes.",10/30/2013,"10/30/2013",12/11/2013,"12/11/2013"
"Food",66677,"Ongoing","Garden-Fresh Foods, Inc.","Milwaukee","WI","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","CA, IL, IN, MA, MI,MN, MO, OH, PA, WI.","F-0520-2014","Class I","Finest Traditions Creamy Cheddar Macaroni, Product Code 10 733147 10156 5, 1/8 lb ","10 733147 10156 5 = 10/30/2013 - 11/18/2013; ",".","1,159,754.46 total pounds, for all varieties","Garden-Fresh Foods is recalling various ready-to-eat salads, slaw, and dip products sold under various brands and codes because they may be contaminated with Listeria monocytogenes.",10/30/2013,"10/30/2013",12/11/2013,"12/11/2013"
"Food",66677,"Ongoing","Garden-Fresh Foods, Inc.","Milwaukee","WI","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","CA, IL, IN, MA, MI,MN, MO, OH, PA, WI.","F-0485-2014","Class I","Garden-Fresh Amish Country Potato Salad, Product Code 0 11596 51005 7, 2/5lb. . . ","11/6/2013 - 11/15/2013",".","1,159,754.46 total pounds, for all varieties","Garden-Fresh Foods is recalling various ready-to-eat salads, slaw, and dip products sold under various brands and codes because they may be contaminated with Listeria monocytogenes.",10/30/2013,"10/30/2013",12/11/2013,"12/11/2013"
"Food",66677,"Ongoing","Garden-Fresh Foods, Inc.","Milwaukee","WI","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","CA, IL, IN, MA, MI,MN, MO, OH, PA, WI.","F-0634-2014","Class I","Finest Traditions Creamy Fruit Salad, 10 733147 10101 5, 1/8 lb "," 10 733147 10101 5 = 10/30/2013 - 11/4/2013 ",".","1,159,754.46 total pounds, for all varieties","Garden-Fresh Foods is recalling various ready-to-eat salads, slaw, and dip products sold under various brands and codes because they may be contaminated with Listeria monocytogenes.",10/30/2013,"10/30/2013",12/11/2013,"12/11/2013"
"Food",66677,"Ongoing","Garden-Fresh Foods, Inc.","Milwaukee","WI","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","CA, IL, IN, MA, MI,MN, MO, OH, PA, WI.","F-0489-2014","Class I","Garden-Fresh German Potato Salad, Product Code 0 11596 91020 8, 2/5 lb.; Garden-Fresh German Potato Salad, Product Code 0 11596 14017 9, 12/16 oz.; Garden-Fresh German Potato Salad, Product Code 0 11596 34319 8, 4/3 lb. Grandpas German Potato Salad, Product Code 0 11596 14016 2, 12/16 oz.; Grandpas German Potato Salad , Product Code 0 11596 91023 9, 2/5 lb.; Dominick's Grandpas German Potato Salad,Product Code 0 11596 14016 2, 12/16 oz ","0 11596 91020 8 = 0/31/2013 - 11/20/2013; 0 11596 14017 9 = 11/2/2013 - 11/15/2013; 0 11596 34319 8 = 11/2/2013 - 11/15/2013. 0 11596 14016 2 = 11/2/2013 - 11/11/2013; 0 11596 91023 9 = 11/10/2013 - 11/23/2013; 0 11596 14016 2 = 11/2/2013 - 11/28/2013; ",".","1,159,754.46 total pounds, for all varieties","Garden-Fresh Foods is recalling various ready-to-eat salads, slaw, and dip products sold under various brands and codes because they may be contaminated with Listeria monocytogenes.",10/30/2013,"10/30/2013",12/11/2013,"12/11/2013"
"Food",66677,"Ongoing","Garden-Fresh Foods, Inc.","Milwaukee","WI","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","CA, IL, IN, MA, MI,MN, MO, OH, PA, WI.","F-0505-2014","Class I","Finest Traditions Roasted Garlic Potato Salad, Product Code 10 733147 10159 6,1/8 lb; ","10 733147 10159 6 = 11/11/2013 - 11/18/2013;",".","1,159,754.46 total pounds, for all varieties","Garden-Fresh Foods is recalling various ready-to-eat salads, slaw, and dip products sold under various brands and codes because they may be contaminated with Listeria monocytogenes.",10/30/2013,"10/30/2013",12/11/2013,"12/11/2013"
"Food",66677,"Ongoing","Garden-Fresh Foods, Inc.","Milwaukee","WI","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","CA, IL, IN, MA, MI,MN, MO, OH, PA, WI.","F-0610-2014","Class I","Finest Traditions Mock Crab Salad, 7 33147 00027 4, 6/16 oz Finest Traditions Mock Crab Salad, 10 733147 10287 6,,1/8 lb ","7 33147 00027 4=10/30/2013 - 11/20/2013; 10 733147 10287 6= 11/4/2013 - 11/20/2013 ",".","1,159,754.46 total pounds, for all varieties","Garden-Fresh Foods is recalling various ready-to-eat salads, slaw, and dip products sold under various brands and codes because they may be contaminated with Listeria monocytogenes.",10/30/2013,"10/30/2013",12/11/2013,"12/11/2013"
"Food",66677,"Ongoing","Garden-Fresh Foods, Inc.","Milwaukee","WI","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","CA, IL, IN, MA, MI,MN, MO, OH, PA, WI.","F-0481-2014","Class I","Garden-Fresh Premium Potato Salad, Product Code 0 11596 91019 2, 2/5 lb. Our Own Premium Potato Salad, Product Code 0 11596 91045 1 , 4/5 lb; "," 0 11596 91019 2 = 11/1/2013 - 11/7/2013; 0 11596 91045 1 = 11/1/2013 - 11/15/2013;",".","1,159,754.46 total pounds, for all varieties","Garden-Fresh Foods is recalling various ready-to-eat salads, slaw, and dip products sold under various brands and codes because they may be contaminated with Listeria monocytogenes.",10/30/2013,"10/30/2013",12/11/2013,"12/11/2013"
"Food",66677,"Ongoing","Garden-Fresh Foods, Inc.","Milwaukee","WI","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","CA, IL, IN, MA, MI,MN, MO, OH, PA, WI.","F-0579-2014","Class I","Finest Traditions Homemade-Style Cole Slaw, 7 33147 00025 0, 6/16 oz; Finest Traditions Homemade-Style Cole Slaw, 10 733147 10170 1, 1/8 lb; ","7 33147 00025 0= 10/30/2013 - 11/11/2013; 10 733147 10170 1 =10/30/2013 - 11/18/2013; ",".","1,159,754.46 total pounds, for all varieties","Garden-Fresh Foods is recalling various ready-to-eat salads, slaw, and dip products sold under various brands and codes because they may be contaminated with Listeria monocytogenes.",10/30/2013,"10/30/2013",12/11/2013,"12/11/2013"
"Food",66677,"Ongoing","Garden-Fresh Foods, Inc.","Milwaukee","WI","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","CA, IL, IN, MA, MI,MN, MO, OH, PA, WI.","F-0671-2014","Class I","Our Own Chili Con Queso Dip, Product code 0 11596 55189 0 11/6/2013 - 11/20/2013 1/5 lb ","0 11596 55189 0 = 11/6/2013 - 11/20/2013 ",".","1,159,754.46 total pounds, for all varieties","Garden-Fresh Foods is recalling various ready-to-eat salads, slaw, and dip products sold under various brands and codes because they may be contaminated with Listeria monocytogenes.",10/30/2013,"10/30/2013",12/11/2013,"12/11/2013"
"Food",66677,"Ongoing","Garden-Fresh Foods, Inc.","Milwaukee","WI","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","CA, IL, IN, MA, MI,MN, MO, OH, PA, WI.","F-0653-2014","Class I","Grandpas Cucumber Dill Dip, Product Code 0 11596 55900 1, 1/5 lb; Chefs Kitchen Cucumber Dill Dip, Product Code 0 11596 06180 1, 6/12 oz ","0 11596 55900 1 = 11/10/2013 - 12/14/2013; 0 11596 06180 1=11/5/2013 - 11/30/2013 ",".","1,159,754.46 total pounds, for all varieties","Garden-Fresh Foods is recalling various ready-to-eat salads, slaw, and dip products sold under various brands and codes because they may be contaminated with Listeria monocytogenes.",10/30/2013,"10/30/2013",12/11/2013,"12/11/2013"
"Food",66677,"Ongoing","Garden-Fresh Foods, Inc.","Milwaukee","WI","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","CA, IL, IN, MA, MI,MN, MO, OH, PA, WI.","F-0670-2014","Class I","Spoon River Buttermilk Ranch Dip, Product Code 0 11596 55685 7, 1/5 lb ","0 11596 55685 7 = 11/4/2013 - 12/9/2013 ",".","1,159,754.46 total pounds, for all varieties","Garden-Fresh Foods is recalling various ready-to-eat salads, slaw, and dip products sold under various brands and codes because they may be contaminated with Listeria monocytogenes.",10/30/2013,"10/30/2013",12/11/2013,"12/11/2013"
"Food",66677,"Ongoing","Garden-Fresh Foods, Inc.","Milwaukee","WI","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","CA, IL, IN, MA, MI,MN, MO, OH, PA, WI.","F-0542-2014","Class I","Garden-Fresh Farm Stand Pasta Salad,Product Code 0 11 11596 52204 9, 1/5 lb "," 0 11 11596 52204 9= 10/30/2013 - 11/20/2013 ; ;",".","1,159,754.46 total pounds, for all varieties","Garden-Fresh Foods is recalling various ready-to-eat salads, slaw, and dip products sold under various brands and codes because they may be contaminated with Listeria monocytogenes.",10/30/2013,"10/30/2013",12/11/2013,"12/11/2013"
"Food",66677,"Ongoing","Garden-Fresh Foods, Inc.","Milwaukee","WI","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","CA, IL, IN, MA, MI,MN, MO, OH, PA, WI.","F-0688-2014","Class I","Weis Tuna Salad,0 41497 05345 2, 9/8 oz ","0 41497 05345 2 = 11/4/2013 - 11/23/2013 ",".","1,159,754.46 total pounds, for all varieties","Garden-Fresh Foods is recalling various ready-to-eat salads, slaw, and dip products sold under various brands and codes because they may be contaminated with Listeria monocytogenes.",10/30/2013,"10/30/2013",12/11/2013,"12/11/2013"
"Food",66677,"Ongoing","Garden-Fresh Foods, Inc.","Milwaukee","WI","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","CA, IL, IN, MA, MI,MN, MO, OH, PA, WI.","F-0533-2014","Class I","Garden-Fresh California Pasta Salad,Product Code 0 11596 82068 2, 2/5 lb ","0 11596 82068 2 = 11/6/2013 - 11/10/2013 ; ;",".","1,159,754.46 total pounds, for all varieties","Garden-Fresh Foods is recalling various ready-to-eat salads, slaw, and dip products sold under various brands and codes because they may be contaminated with Listeria monocytogenes.",10/30/2013,"10/30/2013",12/11/2013,"12/11/2013"
"Food",66677,"Ongoing","Garden-Fresh Foods, Inc.","Milwaukee","WI","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","CA, IL, IN, MA, MI,MN, MO, OH, PA, WI.","F-0559-2014","Class I","Finest Traditions Garden Vegetable Spaghetti, Product Code 10 733147 10196 1, 1/8 lb "," 10 733147 10196 1= 11/4/2013 - 11/20/2013; ;",".","1,159,754.46 total pounds, for all varieties","Garden-Fresh Foods is recalling various ready-to-eat salads, slaw, and dip products sold under various brands and codes because they may be contaminated with Listeria monocytogenes.",10/30/2013,"10/30/2013",12/11/2013,"12/11/2013"
"Food",66677,"Ongoing","Garden-Fresh Foods, Inc.","Milwaukee","WI","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","CA, IL, IN, MA, MI,MN, MO, OH, PA, WI.","F-0507-2014","Class I","Rogges Mustard American Potato Salad, Product Code 0 11596 51053 8, 2/5 lb; ","0 11596 51053 8 = 11/2/2013;",".","1,159,754.46 total pounds, for all varieties","Garden-Fresh Foods is recalling various ready-to-eat salads, slaw, and dip products sold under various brands and codes because they may be contaminated with Listeria monocytogenes.",10/30/2013,"10/30/2013",12/11/2013,"12/11/2013"
"Food",66677,"Ongoing","Garden-Fresh Foods, Inc.","Milwaukee","WI","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","CA, IL, IN, MA, MI,MN, MO, OH, PA, WI.","F-0484-2014","Class I","Garden-Fresh Gourmet Dill Potato Salad, Product Code 0 11596 55137 1, 2/5 lb. . . ","11/6/2013 - 11/15/2013",".","1,159,754.46 total pounds, for all varieties","Garden-Fresh Foods is recalling various ready-to-eat salads, slaw, and dip products sold under various brands and codes because they may be contaminated with Listeria monocytogenes.",10/30/2013,"10/30/2013",12/11/2013,"12/11/2013"
"Food",66677,"Ongoing","Garden-Fresh Foods, Inc.","Milwaukee","WI","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","CA, IL, IN, MA, MI,MN, MO, OH, PA, WI.","F-0519-2014","Class I","Market Pantry Reduced Fat Macaroni Salad, Product Code 0 85239 20118 3, 6/16 oz. ","0 85239 20118 3 =10/31/2013 - 11/2/2013; ",".","1,159,754.46 total pounds, for all varieties","Garden-Fresh Foods is recalling various ready-to-eat salads, slaw, and dip products sold under various brands and codes because they may be contaminated with Listeria monocytogenes.",10/30/2013,"10/30/2013",12/11/2013,"12/11/2013"
"Food",66677,"Ongoing","Garden-Fresh Foods, Inc.","Milwaukee","WI","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","CA, IL, IN, MA, MI,MN, MO, OH, PA, WI.","F-0535-2014","Class I","Garden-Fresh Mediterranean Pasta Salad, Product Code 0 11596 52071 1, 1/5 lb ","0 11596 52071 1 = 10/30/2013 - 11/20/2013 ; ;",".","1,159,754.46 total pounds, for all varieties","Garden-Fresh Foods is recalling various ready-to-eat salads, slaw, and dip products sold under various brands and codes because they may be contaminated with Listeria monocytogenes.",10/30/2013,"10/30/2013",12/11/2013,"12/11/2013"
"Food",66677,"Ongoing","Garden-Fresh Foods, Inc.","Milwaukee","WI","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","CA, IL, IN, MA, MI,MN, MO, OH, PA, WI.","F-0563-2014","Class I","Our Own Greek Village Pasta Salad, Product Code 0 11596 52151 0,1/5 lb "," 0 11596 52151 0 = 11/1/2013 - 11/19/2013 ;",".","1,159,754.46 total pounds, for all varieties","Garden-Fresh Foods is recalling various ready-to-eat salads, slaw, and dip products sold under various brands and codes because they may be contaminated with Listeria monocytogenes.",10/30/2013,"10/30/2013",12/11/2013,"12/11/2013"
"Food",66677,"Ongoing","Garden-Fresh Foods, Inc.","Milwaukee","WI","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","CA, IL, IN, MA, MI,MN, MO, OH, PA, WI.","F-0604-2014","Class I","Garden-Fresh Shrimp Salad, 0 11596 55100 5, 1/5 lb ","0 11596 55100 5 = 10/31/2013 - 11/18/2013 ",".","1,159,754.46 total pounds, for all varieties","Garden-Fresh Foods is recalling various ready-to-eat salads, slaw, and dip products sold under various brands and codes because they may be contaminated with Listeria monocytogenes.",10/30/2013,"10/30/2013",12/11/2013,"12/11/2013"
"Food",66677,"Ongoing","Garden-Fresh Foods, Inc.","Milwaukee","WI","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","CA, IL, IN, MA, MI,MN, MO, OH, PA, WI.","F-0631-2014","Class I","Garden-Fresh Chopped Broccoli Cauliflower Salad Base, Product Code 0 11596 55188 3, 1/5.25lb ","0 11596 55188 3 = 11/20/2013 ",".","1,159,754.46 total pounds, for all varieties","Garden-Fresh Foods is recalling various ready-to-eat salads, slaw, and dip products sold under various brands and codes because they may be contaminated with Listeria monocytogenes.",10/30/2013,"10/30/2013",12/11/2013,"12/11/2013"
"Food",66677,"Ongoing","Garden-Fresh Foods, Inc.","Milwaukee","WI","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","CA, IL, IN, MA, MI,MN, MO, OH, PA, WI.","F-0590-2014","Class I","Archer Farms Four Bean Salad, Product Code 0 85239 24207 0, 6/14 oz ","0 85239 24207 0 = 11/1/2013 - 11/9/2013 ",".","1,159,754.46 total pounds, for all varieties","Garden-Fresh Foods is recalling various ready-to-eat salads, slaw, and dip products sold under various brands and codes because they may be contaminated with Listeria monocytogenes.",10/30/2013,"10/30/2013",12/11/2013,"12/11/2013"
"Food",66677,"Ongoing","Garden-Fresh Foods, Inc.","Milwaukee","WI","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","CA, IL, IN, MA, MI,MN, MO, OH, PA, WI.","F-0613-2014","Class I","Finest Traditions Krab Salad, Product Code 10 733147 10172 5 11/4/2013 - 11/11/2013 1/8 lb Dairy Fresh Krab Salad , Product Code 0 70163 41001 5, 1/5 lb ","10 733147 10172 5= 11/4/2013 - 11/11/2013; 0 70163 41001 5 = 11/3/2013 - 11/24/2013 ",".","1,159,754.46 total pounds, for all varieties","Garden-Fresh Foods is recalling various ready-to-eat salads, slaw, and dip products sold under various brands and codes because they may be contaminated with Listeria monocytogenes.",10/30/2013,"10/30/2013",12/11/2013,"12/11/2013"
"Food",66677,"Ongoing","Garden-Fresh Foods, Inc.","Milwaukee","WI","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","CA, IL, IN, MA, MI,MN, MO, OH, PA, WI.","F-0544-2014","Class I","Garden-Fresh Lite Italian Pasta Salad , Product Code 0 11596 55208 8, 1/5 lb "," 0 11596 55208 8 = 11/5/2013 - 11/19/2013 ; ;",".","1,159,754.46 total pounds, for all varieties","Garden-Fresh Foods is recalling various ready-to-eat salads, slaw, and dip products sold under various brands and codes because they may be contaminated with Listeria monocytogenes.",10/30/2013,"10/30/2013",12/11/2013,"12/11/2013"
"Food",66677,"Ongoing","Garden-Fresh Foods, Inc.","Milwaukee","WI","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","CA, IL, IN, MA, MI,MN, MO, OH, PA, WI.","F-0591-2014","Class I","Finest Traditions Fat Free Bean Salad, Product Code 10 733147 10180 0, 1/8 lb ","10 733147 10180 0= 11/13/2013 - 11/18/2013; ",".","1,159,754.46 total pounds, for all varieties","Garden-Fresh Foods is recalling various ready-to-eat salads, slaw, and dip products sold under various brands and codes because they may be contaminated with Listeria monocytogenes.",10/30/2013,"10/30/2013",12/11/2013,"12/11/2013"
"Food",66677,"Ongoing","Garden-Fresh Foods, Inc.","Milwaukee","WI","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","CA, IL, IN, MA, MI,MN, MO, OH, PA, WI.","F-0654-2014","Class I","Grandpas Spinach Dip, 0 11596 55901 8, 1/5 lb; Archer Farms Spinach Dip, Product Code 0 85239 69052 9, 6/11 oz; Archer Farms Spinach Dip, Product Code 0 85239 69052 9; 4/18 oz; Finest Traditions Spinach Dip,Product Code 7 33147 10538 2, 6/8 oz; Finest Traditions Spinach Dip, Product Code 10 733147 10123 7,2013 1/8 lb; Spoon River Spinach Dip, Product Code 0 1159655681 9. 1/5 lb; Spoon River Spinach Dip, Product Code 0 11596 06281 5, 6/12 oz; Our Own Spinach Dip, Product code 0 11596 55149 4, 1/5 lb ","0 11596 55901 8 =11/5/2013 - 12/10/2013; 0 85239 69052 9 = 11/4/2013 - 11/16/2013; 7 33147 10538 2= 11/6/2013 - 11/25/2013; 10 733147 10123 7=11/4/2013 - 11/18/2013; 0 85239 69052 9= 11/9/2013 - 11/16/2013; 1159655681 9 = 11/11/2013 - 12/2/2013; 0 11596 06281 5 = 11/5/2013; 0 11596 55149 4= 10/31/2013 - 11/30/2013 ",".","1,159,754.46 total pounds, for all varieties","Garden-Fresh Foods is recalling various ready-to-eat salads, slaw, and dip products sold under various brands and codes because they may be contaminated with Listeria monocytogenes.",10/30/2013,"10/30/2013",12/11/2013,"12/11/2013"
"Food",66677,"Ongoing","Garden-Fresh Foods, Inc.","Milwaukee","WI","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","CA, IL, IN, MA, MI,MN, MO, OH, PA, WI.","F-0668-2014","Class I","Spoon River Pimiento Spread, 0 11596 55678 9, 1/5 lb ","0 11596 55678 9 = 11/11/2013 - 12/9/2013 ",".","1,159,754.46 total pounds, for all varieties","Garden-Fresh Foods is recalling various ready-to-eat salads, slaw, and dip products sold under various brands and codes because they may be contaminated with Listeria monocytogenes.",10/30/2013,"10/30/2013",12/11/2013,"12/11/2013"
"Food",66677,"Ongoing","Garden-Fresh Foods, Inc.","Milwaukee","WI","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","CA, IL, IN, MA, MI,MN, MO, OH, PA, WI.","F-0587-2014","Class I","Garden-Fresh Combo Bean Salad, Product Code 0 11596 52013 1, 2/5 lb ","0 11596 52013 1 = 11/05/2013 - 12/15/2013 ",".","1,159,754.46 total pounds, for all varieties","Garden-Fresh Foods is recalling various ready-to-eat salads, slaw, and dip products sold under various brands and codes because they may be contaminated with Listeria monocytogenes.",10/30/2013,"10/30/2013",12/11/2013,"12/11/2013"
"Food",66677,"Ongoing","Garden-Fresh Foods, Inc.","Milwaukee","WI","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","CA, IL, IN, MA, MI,MN, MO, OH, PA, WI.","F-0570-2014","Class I","Garden-Fresh Creamy Shredded Cole Slaw, Product Code 0 11596 53005 5, 4/8 lb Garden-Fresh Creamy Shredded Cole Slaw,Product Code 0 11596 93014 5, 2/5 lb Garden-Fresh Creamy Shredded Cole Slaw, Product Code 0 11596 14022 3, 12/16 oz Garden-Fresh Creamy Shredded Cole Slaw, Product Code 0 11596 24203 3, 8/2 lb Garden-Fresh Creamy Shredded Cole Slaw, Product Code 0 11596 34309 9, 6/3 lb Weis Creamy Cole Slaw , 0 41497 05837 2, 6/16 oz; Weis Creamy Cole Slaw, 0 41497 05906 5, 4/3 lb; Weis Creamy Cole Slaw , 0 11596 53101 4, 2/5 lb; ","0 11596 53005 5 = 10/31/2013 - 11/19/2013; 0 11596 93014 5 =10/30/2013 - 11/20/2013; 0 11596 14022 3 =11/1/2013 - 11/18/2013; 0 11596 24203 3=11/8/2013 - 11/15/2013; 0 11596 34309 9 =10/30/2013 - 11/20/2013; 0 41497 05837 2=10/30/2013 - 11/19/2013; 0 41497 05906 5=10/30/2013 - 11/19/2013; 0 11596 53101 4=10/30/2013 - 11/19/2013; ",".","1,159,754.46 total pounds, for all varieties","Garden-Fresh Foods is recalling various ready-to-eat salads, slaw, and dip products sold under various brands and codes because they may be contaminated with Listeria monocytogenes.",10/30/2013,"10/30/2013",12/11/2013,"12/11/2013"
"Food",66677,"Ongoing","Garden-Fresh Foods, Inc.","Milwaukee","WI","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","CA, IL, IN, MA, MI,MN, MO, OH, PA, WI.","F-0536-2014","Class I","Garden-Fresh Asian Vegetable Orzo,Product Code 0 11596 52073 5, 1/5 lb ","0 11596 52073 5 = 11/1/2013 - 11/18/2013 ; ;",".","1,159,754.46 total pounds, for all varieties","Garden-Fresh Foods is recalling various ready-to-eat salads, slaw, and dip products sold under various brands and codes because they may be contaminated with Listeria monocytogenes.",10/30/2013,"10/30/2013",12/11/2013,"12/11/2013"
"Food",66677,"Ongoing","Garden-Fresh Foods, Inc.","Milwaukee","WI","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","CA, IL, IN, MA, MI,MN, MO, OH, PA, WI.","F-0661-2014","Class I","Grandpa's Bacon Parmesan Dip, Product Code 5904, 1/5 lb.; Archer Farms Bacon Parmesan Dip, Product Code 0 85239 99017 9, 6/11 oz. ","5904 = 11/12/2013; 0 85239 99017 9 =11/8/2013 - 11/16/2013 ",".","1,159,754.46 total pounds, for all varieties","Garden-Fresh Foods is recalling various ready-to-eat salads, slaw, and dip products sold under various brands and codes because they may be contaminated with Listeria monocytogenes.",10/30/2013,"10/30/2013",12/11/2013,"12/11/2013"
"Food",66677,"Ongoing","Garden-Fresh Foods, Inc.","Milwaukee","WI","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","CA, IL, IN, MA, MI,MN, MO, OH, PA, WI.","F-0690-2014","Class I","Weis Baked Lima Beans , Product Code 0 11596 52111 4, 1/5 lb ","0 11596 52111 4 = 10/30/2013 - 11/20/2013 ",".","1,159,754.46 total pounds, for all varieties","Garden-Fresh Foods is recalling various ready-to-eat salads, slaw, and dip products sold under various brands and codes because they may be contaminated with Listeria monocytogenes.",10/30/2013,"10/30/2013",12/11/2013,"12/11/2013"
"Food",66677,"Ongoing","Garden-Fresh Foods, Inc.","Milwaukee","WI","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","CA, IL, IN, MA, MI,MN, MO, OH, PA, WI.","F-0669-2014","Class I","Spoon River Western Veggie Dip, 0 11596 55679 6. 1/5 lb ","0 11596 55679 6 = 11/11/2013 ",".","1,159,754.46 total pounds, for all varieties","Garden-Fresh Foods is recalling various ready-to-eat salads, slaw, and dip products sold under various brands and codes because they may be contaminated with Listeria monocytogenes.",10/30/2013,"10/30/2013",12/11/2013,"12/11/2013"
"Food",66677,"Ongoing","Garden-Fresh Foods, Inc.","Milwaukee","WI","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","CA, IL, IN, MA, MI,MN, MO, OH, PA, WI.","F-0532-2014","Class II","Garden-Fresh Whole Grain Penne With Spinach , Tomato & Feta, Product Code 0 11596 52063 6, 1/5 lb ","0 11596 52063 6 = 10/30/2013 - 11/19/2013 ; ;",".","1,159,754.46 total pounds, for all varieties","Garden-Fresh Foods is recalling various ready-to-eat salads, slaw, and dip products sold under various brands and codes because they may be contaminated with Listeria monocytogenes.",10/30/2013,"10/30/2013",12/11/2013,"12/11/2013"
"Food",66677,"Ongoing","Garden-Fresh Foods, Inc.","Milwaukee","WI","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","CA, IL, IN, MA, MI,MN, MO, OH, PA, WI.","F-0530-2014","Class I","Garden- Fresh Southwestern Pasta Salad, Product Code 0 11596 52046 9, 1/5 lb ","0 11596 52046 9 = 10/30/2013 - 11/13/2013 ; ;",".","1,159,754.46 total pounds, for all varieties","Garden-Fresh Foods is recalling various ready-to-eat salads, slaw, and dip products sold under various brands and codes because they may be contaminated with Listeria monocytogenes.",10/30/2013,"10/30/2013",12/11/2013,"12/11/2013"
"Food",66677,"Ongoing","Garden-Fresh Foods, Inc.","Milwaukee","WI","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","CA, IL, IN, MA, MI,MN, MO, OH, PA, WI.","F-0625-2014","Class I","Garden-Fresh Anti Pasto Salad Kit, Product Code 0 11596 65634 2 , 1/6 lb ","0 11596 65634 2 = 10/30/2013 - 11/6/2013 ",".","1,159,754.46 total pounds, for all varieties","Garden-Fresh Foods is recalling various ready-to-eat salads, slaw, and dip products sold under various brands and codes because they may be contaminated with Listeria monocytogenes.",10/30/2013,"10/30/2013",12/11/2013,"12/11/2013"
"Food",66677,"Ongoing","Garden-Fresh Foods, Inc.","Milwaukee","WI","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","CA, IL, IN, MA, MI,MN, MO, OH, PA, WI.","F-0622-2014","Class I","Taffy Apple Salad Kit, 0 11596 55049 7, 21 1/5 lb "," 0 11596 55049 7= 10/30/2013 ",".","1,159,754.46 total pounds, for all varieties","Garden-Fresh Foods is recalling various ready-to-eat salads, slaw, and dip products sold under various brands and codes because they may be contaminated with Listeria monocytogenes.",10/30/2013,"10/30/2013",12/11/2013,"12/11/2013"
"Food",66677,"Ongoing","Garden-Fresh Foods, Inc.","Milwaukee","WI","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","CA, IL, IN, MA, MI,MN, MO, OH, PA, WI.","F-0672-2014","Class I","Roundy's Bagel Spread, Product Code 0 11596 06156 6 11/2/2013 - 11/9/2013 6/12 oz ","0 11596 06156 6 = 11/2/2013 - 11/9/2013 ",".","1,159,754.46 total pounds, for all varieties","Garden-Fresh Foods is recalling various ready-to-eat salads, slaw, and dip products sold under various brands and codes because they may be contaminated with Listeria monocytogenes.",10/30/2013,"10/30/2013",12/11/2013,"12/11/2013"
"Food",66677,"Ongoing","Garden-Fresh Foods, Inc.","Milwaukee","WI","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","CA, IL, IN, MA, MI,MN, MO, OH, PA, WI.","F-0630-2014","Class I","Garden-Fresh Broccoli Cheese Salad Base,Product Code 0 11596 55136 4, 1/5.25lb ","0 11596 55136 4 = 10/31/2013 - 11/20/2013 ",".","1,159,754.46 total pounds, for all varieties","Garden-Fresh Foods is recalling various ready-to-eat salads, slaw, and dip products sold under various brands and codes because they may be contaminated with Listeria monocytogenes.",10/30/2013,"10/30/2013",12/11/2013,"12/11/2013"
"Food",66677,"Ongoing","Garden-Fresh Foods, Inc.","Milwaukee","WI","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","CA, IL, IN, MA, MI,MN, MO, OH, PA, WI.","F-0511-2014","Class I","Dairy Fresh Homemade Mustard Potato Salad, Product Code 0 70163 56700 9, 2/5 lb; ","0 70163 56700 9 = 11/17/2013;",".","1,159,754.46 total pounds, for all varieties","Garden-Fresh Foods is recalling various ready-to-eat salads, slaw, and dip products sold under various brands and codes because they may be contaminated with Listeria monocytogenes.",10/30/2013,"10/30/2013",12/11/2013,"12/11/2013"
"Food",66677,"Ongoing","Garden-Fresh Foods, Inc.","Milwaukee","WI","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","CA, IL, IN, MA, MI,MN, MO, OH, PA, WI.","F-0588-2014","Class I","Garden-Fresh Texas Style BBQ Beans, 0 11596 55131 9, 1/5 lb ","0 11596 55131 9 = 10/31/2013 - 11/18/2013 ",".","1,159,754.46 total pounds, for all varieties","Garden-Fresh Foods is recalling various ready-to-eat salads, slaw, and dip products sold under various brands and codes because they may be contaminated with Listeria monocytogenes.",10/30/2013,"10/30/2013",12/11/2013,"12/11/2013"
"Food",66677,"Ongoing","Garden-Fresh Foods, Inc.","Milwaukee","WI","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","CA, IL, IN, MA, MI,MN, MO, OH, PA, WI.","F-0664-2014","Class I","Archer Farms Vanilla Creme Dip, Product Code 0 85239 99014 8, 6/12 oz ","0 85239 99014 8 = 11/10/2013 - 11/15/2013",".","1,159,754.46 total pounds, for all varieties","Garden-Fresh Foods is recalling various ready-to-eat salads, slaw, and dip products sold under various brands and codes because they may be contaminated with Listeria monocytogenes.",10/30/2013,"10/30/2013",12/11/2013,"12/11/2013"
"Food",66677,"Ongoing","Garden-Fresh Foods, Inc.","Milwaukee","WI","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","CA, IL, IN, MA, MI,MN, MO, OH, PA, WI.","F-0482-2014","Class I","Garden-Fresh Country Style Potato Salad, Product Code 0 11596 51075 0, 2/5lb. ","11/6/2013 - 11/13/2013",".","1,159,754.46 total pounds, for all varieties","Garden-Fresh Foods is recalling various ready-to-eat salads, slaw, and dip products sold under various brands and codes because they may be contaminated with Listeria monocytogenes.",10/30/2013,"10/30/2013",12/11/2013,"12/11/2013"
"Food",66677,"Ongoing","Garden-Fresh Foods, Inc.","Milwaukee","WI","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","CA, IL, IN, MA, MI,MN, MO, OH, PA, WI.","F-0593-2014","Class I","Garden-Fresh Confetti Bean Salad, Product Code 0 11596 52042 1,1/5 lb ","0 11596 52042 1= 10/31/2013 - 11/2/2013",".","1,159,754.46 total pounds, for all varieties","Garden-Fresh Foods is recalling various ready-to-eat salads, slaw, and dip products sold under various brands and codes because they may be contaminated with Listeria monocytogenes.",10/30/2013,"10/30/2013",12/11/2013,"12/11/2013"
"Food",66677,"Ongoing","Garden-Fresh Foods, Inc.","Milwaukee","WI","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","CA, IL, IN, MA, MI,MN, MO, OH, PA, WI.","F-0648-2014","Class I","Finest Traditions Mint Chocolate Mousse, Product Code 10 733147 11017 8 11/4/2013 - 11/18/2013 1/5 lb ","10 733147 11017 8= 11/4/2013 - 11/18/2013 ",".","1,159,754.46 total pounds, for all varieties","Garden-Fresh Foods is recalling various ready-to-eat salads, slaw, and dip products sold under various brands and codes because they may be contaminated with Listeria monocytogenes.",10/30/2013,"10/30/2013",12/11/2013,"12/11/2013"
"Food",66677,"Ongoing","Garden-Fresh Foods, Inc.","Milwaukee","WI","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","CA, IL, IN, MA, MI,MN, MO, OH, PA, WI.","F-0638-2014","Class I","Garden-Fresh Baked Bread Pudding, Product Code 0 11596 75034 7, 1/7 lb; Garden-Fresh Baked Bread Pudding, Product Code 0 11596 07034 6, 6/12 oz; Finest Traditions Baked Bread Pudding, Product Code 10 733147 10099 5,,1/7 lb "," 0 11596 75034 7 = 10/30/2013 - 11/19/2013 ; 0 11596 07034 6 = 10/31/2013 - 11/20/2013 ; 10 733147 10099 5= 10/31/2013 - 11/18/2013 ",".","1,159,754.46 total pounds, for all varieties","Garden-Fresh Foods is recalling various ready-to-eat salads, slaw, and dip products sold under various brands and codes because they may be contaminated with Listeria monocytogenes.",10/30/2013,"10/30/2013",12/11/2013,"12/11/2013"
"Food",66677,"Ongoing","Garden-Fresh Foods, Inc.","Milwaukee","WI","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","CA, IL, IN, MA, MI,MN, MO, OH, PA, WI.","F-0687-2014","Class I","Grandpas Fresh Bruschetta, Product Code 5911 , 1/5 lb ","5911 = 10/31/2013 - 11/30/2013 ",".","1,159,754.46 total pounds, for all varieties","Garden-Fresh Foods is recalling various ready-to-eat salads, slaw, and dip products sold under various brands and codes because they may be contaminated with Listeria monocytogenes.",10/30/2013,"10/30/2013",12/11/2013,"12/11/2013"
"Food",66677,"Ongoing","Garden-Fresh Foods, Inc.","Milwaukee","WI","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","CA, IL, IN, MA, MI,MN, MO, OH, PA, WI.","F-0621-2014","Class I","Tropical Waldrof Salad Kit, 0 11596 65047 0, 1/6.125 lb ","0 11596 65047 0= 10/30/2013 ",".","1,159,754.46 total pounds, for all varieties","Garden-Fresh Foods is recalling various ready-to-eat salads, slaw, and dip products sold under various brands and codes because they may be contaminated with Listeria monocytogenes.",10/30/2013,"10/30/2013",12/11/2013,"12/11/2013"
"Food",66677,"Ongoing","Garden-Fresh Foods, Inc.","Milwaukee","WI","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","CA, IL, IN, MA, MI,MN, MO, OH, PA, WI.","F-0585-2014","Class I","Garden-Fresh Calico Beans, 0 11596 52596 9, 1/5 lb; Garden-Fresh Calico Beans, 0 11596 52500 6, 4/5 lb; ","0 11596 52596 9 = 11/2/2013 - 11/20/2013 0 11596 52500 6 = 10/31/2013 - 11/20/2013",".","1,159,754.46 total pounds, for all varieties","Garden-Fresh Foods is recalling various ready-to-eat salads, slaw, and dip products sold under various brands and codes because they may be contaminated with Listeria monocytogenes.",10/30/2013,"10/30/2013",12/11/2013,"12/11/2013"
"Food",66677,"Ongoing","Garden-Fresh Foods, Inc.","Milwaukee","WI","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","CA, IL, IN, MA, MI,MN, MO, OH, PA, WI.","F-0509-2014","Class I","Dairy Fresh Potato Salad With Egg, Product Code 0 70163 89085 5, 2/5 lb; "," 0 70163 89085 5 = 11/5/2013 - 11/18/2013;",".","1,159,754.46 total pounds, for all varieties","Garden-Fresh Foods is recalling various ready-to-eat salads, slaw, and dip products sold under various brands and codes because they may be contaminated with Listeria monocytogenes.",10/30/2013,"10/30/2013",12/11/2013,"12/11/2013"
"Food",66677,"Ongoing","Garden-Fresh Foods, Inc.","Milwaukee","WI","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","CA, IL, IN, MA, MI,MN, MO, OH, PA, WI.","F-0566-2014","Class I","Dairy Fresh, Pasta & Tomatoes , Product Code 0 70163 41000 8, 1/5 lb ","0 70163 41000 8=11/12/2013 ;",".","1,159,754.46 total pounds, for all varieties","Garden-Fresh Foods is recalling various ready-to-eat salads, slaw, and dip products sold under various brands and codes because they may be contaminated with Listeria monocytogenes.",10/30/2013,"10/30/2013",12/11/2013,"12/11/2013"
"Food",66677,"Ongoing","Garden-Fresh Foods, Inc.","Milwaukee","WI","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","CA, IL, IN, MA, MI,MN, MO, OH, PA, WI.","F-0573-2014","Class I","Garden-Fresh Poppy Seed Cole Slaw, Product Code 0 11596 83016 2 10/31/2013 - 11/20/2013 1/8 lb ","0 11596 83016 2 =10/31/2013 - 11/20/2013 ",".","1,159,754.46 total pounds, for all varieties","Garden-Fresh Foods is recalling various ready-to-eat salads, slaw, and dip products sold under various brands and codes because they may be contaminated with Listeria monocytogenes.",10/30/2013,"10/30/2013",12/11/2013,"12/11/2013"
"Food",66677,"Ongoing","Garden-Fresh Foods, Inc.","Milwaukee","WI","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","CA, IL, IN, MA, MI,MN, MO, OH, PA, WI.","F-0547-2014","Class I","Garden-Fresh Penne Pasta With Grape Tomatoes Product Code ,0 11596 55625 3, 1/5 lb ","0 11596 55625 3 = 11/2/2013 - 11/14/2013 ; ;",".","1,159,754.46 total pounds, for all varieties","Garden-Fresh Foods is recalling various ready-to-eat salads, slaw, and dip products sold under various brands and codes because they may be contaminated with Listeria monocytogenes.",10/30/2013,"10/30/2013",12/11/2013,"12/11/2013"
"Food",66677,"Ongoing","Garden-Fresh Foods, Inc.","Milwaukee","WI","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","CA, IL, IN, MA, MI,MN, MO, OH, PA, WI.","F-0680-2014","Class II","Finest Traditions Broccoli Cauliflower Dressing, 10 733147 10647 8, 5/2 lb ","10 733147 10647 8 = 10/30/2013 - 11/18/2013 ",".","1,159,754.46 total pounds, for all varieties","Garden-Fresh Foods is recalling various ready-to-eat salads, slaw, and dip products sold under various brands and codes because they may be contaminated with Listeria monocytogenes.",10/30/2013,"10/30/2013",12/11/2013,"12/11/2013"
"Food",66677,"Ongoing","Garden-Fresh Foods, Inc.","Milwaukee","WI","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","CA, IL, IN, MA, MI,MN, MO, OH, PA, WI.","F-0488-2014","Class I","Garden-Fresh Mustard Potato Salad, Product Code 0 11596 51013 2, 2/5 lb. Garden-Fresh Mustard Potato Salad, Product Code 0 11596 14010 0, 12/16 oz. Garden-Fresh Mustard Potato Salad, Product Code 0 11596 24215 6, 8/2.lb Market Pantry Mustard Potato Salad, Product Code 0 85239 24100 4, 4/3 lb. Market Pantry Mustard Potato Salad, Product Code 0 85329 24104 2, 6/16 oz.; Spartan Mustard Potato Salad,Product Code 0 11213 90319 4, 6/16 oz; . ","0 11596 14010 0 = 10/30/2013 - 11/20/2013; 0 11596 51013 2 = 10/30/2013 - 11/18/2013; 0 11596 24215 6 = 11/8/2013 - 11/20/2013; 0 85239 24100 4 = 10/30/2013; 0 85329 24104 2 = 10/30/2013; 0 11213 90319 4 = 10/30/2013 - 11/20/2013; ",".","1,159,754.46 total pounds, for all varieties","Garden-Fresh Foods is recalling various ready-to-eat salads, slaw, and dip products sold under various brands and codes because they may be contaminated with Listeria monocytogenes.",10/30/2013,"10/30/2013",12/11/2013,"12/11/2013"
"Food",66677,"Ongoing","Garden-Fresh Foods, Inc.","Milwaukee","WI","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","CA, IL, IN, MA, MI,MN, MO, OH, PA, WI.","F-0666-2014","Class I","Finest Traditions Southwest Dip , Product Code 7 33147 10540 5, 6/8 oz Finest Traditions Southwest Dip ,Product Code 10 733147 10853 3, 1/8 lb ","7 33147 10540 5 = 11/6/2013 - 11/25/2013; 10 733147 10853 3= 11/6/2013 ",".","1,159,754.46 total pounds, for all varieties","Garden-Fresh Foods is recalling various ready-to-eat salads, slaw, and dip products sold under various brands and codes because they may be contaminated with Listeria monocytogenes.",10/30/2013,"10/30/2013",12/11/2013,"12/11/2013"
"Food",66677,"Ongoing","Garden-Fresh Foods, Inc.","Milwaukee","WI","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","CA, IL, IN, MA, MI,MN, MO, OH, PA, WI.","F-0609-2014","Class I","Archer Farms Neptune Salad, 0 85239 20242 5, 6/6 oz Archer Farms Neptune Salad, 0 85239 20243 2, 6/14 oz ","0 85239 20242 5= 11/3/2013; 0 85239 20243 2= 10/28/2013 - 11/3/2013 ",".","1,159,754.46 total pounds, for all varieties","Garden-Fresh Foods is recalling various ready-to-eat salads, slaw, and dip products sold under various brands and codes because they may be contaminated with Listeria monocytogenes.",10/30/2013,"10/30/2013",12/11/2013,"12/11/2013"
"Food",66677,"Ongoing","Garden-Fresh Foods, Inc.","Milwaukee","WI","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","CA, IL, IN, MA, MI,MN, MO, OH, PA, WI.","F-0679-2014","Class I","Grandpas Black Bean Salsa, Product Code 5917, 1/5 lb; Roundy's Black Bean Salsa , Product Code 0 11596 06118 4, 12/15 oz ","5917 = 11/1/2013 - 11/30/2013; 0 11596 06118 4= 11/3/2013 - 11/30/2013 ",".","1,159,754.46 total pounds, for all varieties","Garden-Fresh Foods is recalling various ready-to-eat salads, slaw, and dip products sold under various brands and codes because they may be contaminated with Listeria monocytogenes.",10/30/2013,"10/30/2013",12/11/2013,"12/11/2013"
"Food",66677,"Ongoing","Garden-Fresh Foods, Inc.","Milwaukee","WI","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","CA, IL, IN, MA, MI,MN, MO, OH, PA, WI.","F-0523-2014","Class I","Garden-Fresh Italian Market Salad Kit, Product Code 0 11596 62208 8 , 1/5.12lb ","0 11596 62208 8 = 10/30/2013 - 11/11/2013;",".","1,159,754.46 total pounds, for all varieties","Garden-Fresh Foods is recalling various ready-to-eat salads, slaw, and dip products sold under various brands and codes because they may be contaminated with Listeria monocytogenes.",10/30/2013,"10/30/2013",12/11/2013,"12/11/2013"
"Food",66677,"Ongoing","Garden-Fresh Foods, Inc.","Milwaukee","WI","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","CA, IL, IN, MA, MI,MN, MO, OH, PA, WI.","F-0607-2014","Class I","Garden-Fresh Seafood Salad Rouille, 0 11596 55187 6, 1/5 lb ","0 11596 55187 6 =10/31/2013 - 11/18/2013 ",".","1,159,754.46 total pounds, for all varieties","Garden-Fresh Foods is recalling various ready-to-eat salads, slaw, and dip products sold under various brands and codes because they may be contaminated with Listeria monocytogenes.",10/30/2013,"10/30/2013",12/11/2013,"12/11/2013"
"Food",66677,"Ongoing","Garden-Fresh Foods, Inc.","Milwaukee","WI","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","CA, IL, IN, MA, MI,MN, MO, OH, PA, WI.","F-0518-2014","Class I","Weis Amish Macaroni Salad, Product Code 0 41497 05844 0, 12/16 oz Weis Amish Macaroni Salad, Product Code 0 41497 05905 8 , 4/3 lb Weis Amish Macaroni Salad,Product Code 0 11596 52105 3 , 2/5 lb ","0 41497 05844 0 = 10/30/2013 - 11/19/2013; 0 41497 05905 8 = 10/30/2013 - 11/19/2013; 0 11596 52105 3 = 10/30/2013 - 11/19/2013; ",".","1,159,754.46 total pounds, for all varieties","Garden-Fresh Foods is recalling various ready-to-eat salads, slaw, and dip products sold under various brands and codes because they may be contaminated with Listeria monocytogenes.",10/30/2013,"10/30/2013",12/11/2013,"12/11/2013"
"Food",66677,"Ongoing","Garden-Fresh Foods, Inc.","Milwaukee","WI","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","CA, IL, IN, MA, MI,MN, MO, OH, PA, WI.","F-0632-2014","Class I","Garden-Fresh Hawaiian Salad , Product Code 0 11596 55058 9, 1/5 lb; Our Own Hawaiian Salad, Product Code 0 11596 45068 1, 1/4 lb ","0 11596 55058 9 = 11/2/2013 - 11/20/2013; 0 11596 45068 1= 10/31/2013 - 11/20/2013 ",".","1,159,754.46 total pounds, for all varieties","Garden-Fresh Foods is recalling various ready-to-eat salads, slaw, and dip products sold under various brands and codes because they may be contaminated with Listeria monocytogenes.",10/30/2013,"10/30/2013",12/11/2013,"12/11/2013"
"Food",66677,"Ongoing","Garden-Fresh Foods, Inc.","Milwaukee","WI","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","CA, IL, IN, MA, MI,MN, MO, OH, PA, WI.","F-0478-2014","Class I","Garden-Fresh Chipotle Ranch Potato Salad, Product Code 0 11596 51002 6, 5 lb. ","11/7/2013 -11/20/2013",".","1,159,754.46 total pounds, for all varieties","Garden-Fresh Foods is recalling various ready-to-eat salads, slaw, and dip products sold under various brands and codes because they may be contaminated with Listeria monocytogenes.",10/30/2013,"10/30/2013",12/11/2013,"12/11/2013"
"Food",66677,"Ongoing","Garden-Fresh Foods, Inc.","Milwaukee","WI","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","CA, IL, IN, MA, MI,MN, MO, OH, PA, WI.","F-0521-2014","Class I","Spoon River Signature Macaroni Salad, Product Code 0 00 11596 34212 2, 2/5 lb ","0 00 11596 34212 2 = 10/31/2013 - 11/14/2013; ",".","1,159,754.46 total pounds, for all varieties","Garden-Fresh Foods is recalling various ready-to-eat salads, slaw, and dip products sold under various brands and codes because they may be contaminated with Listeria monocytogenes.",10/30/2013,"10/30/2013",12/11/2013,"12/11/2013"
"Food",66677,"Ongoing","Garden-Fresh Foods, Inc.","Milwaukee","WI","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","CA, IL, IN, MA, MI,MN, MO, OH, PA, WI.","F-0635-2014","Class I","Garden-Fresh Strawberry Yogurt Cheesecake Dessert, Product Code 0 11 11596 55028 8, 1/5 lb; Lipari Old Tyme Strawberry Yogurt Cheesecake, Product Code 0 94776 03303 4, 1/5 lb ","0 11 11596 55028 8 = 10/30/2013 - 11/20/2013; 0 94776 03303 4= 11/6/2013 - 11/30/2013 ",".","1,159,754.46 total pounds, for all varieties","Garden-Fresh Foods is recalling various ready-to-eat salads, slaw, and dip products sold under various brands and codes because they may be contaminated with Listeria monocytogenes.",10/30/2013,"10/30/2013",12/11/2013,"12/11/2013"
"Food",66677,"Ongoing","Garden-Fresh Foods, Inc.","Milwaukee","WI","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","CA, IL, IN, MA, MI,MN, MO, OH, PA, WI.","F-0675-2014","Class II","Grandpas Fresh Salsa, Product Code 5912, 1/5 lb; Grandpas Fresh Salsa, Product Code 5913, 19 4/5 lb; Roundy's Fresh Salsa Product Code 0 11596 06117 7, 12/15 oz ","5912 = 11/2/2013 - 11/30/2013; 5913 = 11/2/2013 - 11/30/2013; 0 11596 06117 7 = 11/2/2013 - 11/30/2013 ",".","1,159,754.46 total pounds, for all varieties","Garden-Fresh Foods is recalling various ready-to-eat salads, slaw, and dip products sold under various brands and codes because they may be contaminated with Listeria monocytogenes.",10/30/2013,"10/30/2013",12/11/2013,"12/11/2013"
"Food",66677,"Ongoing","Garden-Fresh Foods, Inc.","Milwaukee","WI","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","CA, IL, IN, MA, MI,MN, MO, OH, PA, WI.","F-0580-2014","Class I","Dairy Fresh Homemade Dixie Cole Slaw, Product Code 0 70163 55890 8,2/5 lb ","70163 55890 8 =11/17/2013 - 11/23/2013;",".","1,159,754.46 total pounds, for all varieties","Garden-Fresh Foods is recalling various ready-to-eat salads, slaw, and dip products sold under various brands and codes because they may be contaminated with Listeria monocytogenes.",10/30/2013,"10/30/2013",12/11/2013,"12/11/2013"
"Food",66677,"Ongoing","Garden-Fresh Foods, Inc.","Milwaukee","WI","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","CA, IL, IN, MA, MI,MN, MO, OH, PA, WI.","F-0683-2014","Class II","Farmers Market Salsa - Habanero - Hot , 0 11596 06144 3, 6/15 oz ","0 11596 06144 3 =11/10/2013 - 11/30/2013 ",".","1,159,754.46 total pounds, for all varieties","Garden-Fresh Foods is recalling various ready-to-eat salads, slaw, and dip products sold under various brands and codes because they may be contaminated with Listeria monocytogenes.",10/30/2013,"10/30/2013",12/11/2013,"12/11/2013"
"Food",66677,"Ongoing","Garden-Fresh Foods, Inc.","Milwaukee","WI","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","CA, IL, IN, MA, MI,MN, MO, OH, PA, WI.","F-0524-2014","Class I","Garden-Fresh Bacon Mac & Cheddar Salad Kit,Product Code 0 11596 62209 5, 1/5.75lb ","0 11596 62209 5 = 10/30/2013 - 11/20/2013;",".","1,159,754.46 total pounds, for all varieties","Garden-Fresh Foods is recalling various ready-to-eat salads, slaw, and dip products sold under various brands and codes because they may be contaminated with Listeria monocytogenes.",10/30/2013,"10/30/2013",12/11/2013,"12/11/2013"
"Food",66677,"Ongoing","Garden-Fresh Foods, Inc.","Milwaukee","WI","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","CA, IL, IN, MA, MI,MN, MO, OH, PA, WI.","F-0561-2014","Class I","Finest Traditions Pea & Cheese Pasta Salad, Product Code 10 733147 10146 6, 1/8 lb ,","0 733147 10146 6 = 10/30/2013 - 11/20/2013 ;",".","1,159,754.46 total pounds, for all varieties","Garden-Fresh Foods is recalling various ready-to-eat salads, slaw, and dip products sold under various brands and codes because they may be contaminated with Listeria monocytogenes.",10/30/2013,"10/30/2013",12/11/2013,"12/11/2013"
"Food",66677,"Ongoing","Garden-Fresh Foods, Inc.","Milwaukee","WI","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","CA, IL, IN, MA, MI,MN, MO, OH, PA, WI.","F-0576-2014","Class I","Weis Pepper Cabbage, 0 11596 53102 1, 2/5 lb ","0 11596 53102 1=11/1/2013 - 11/20/201313 ",".","1,159,754.46 total pounds, for all varieties","Garden-Fresh Foods is recalling various ready-to-eat salads, slaw, and dip products sold under various brands and codes because they may be contaminated with Listeria monocytogenes.",10/30/2013,"10/30/2013",12/11/2013,"12/11/2013"
"Food",66677,"Ongoing","Garden-Fresh Foods, Inc.","Milwaukee","WI","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","CA, IL, IN, MA, MI,MN, MO, OH, PA, WI.","F-0689-2014","Class I","Weis Seafood Supreme, 0 11596 55218 7, 1/5 lb ","0 11596 55218 7 = 10/30/2013 - 11/20/2013 ",".","1,159,754.46 total pounds, for all varieties","Garden-Fresh Foods is recalling various ready-to-eat salads, slaw, and dip products sold under various brands and codes because they may be contaminated with Listeria monocytogenes.",10/30/2013,"10/30/2013",12/11/2013,"12/11/2013"
"Food",66677,"Ongoing","Garden-Fresh Foods, Inc.","Milwaukee","WI","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","CA, IL, IN, MA, MI,MN, MO, OH, PA, WI.","F-0528-2014","Class I","Garden-Fresh Greek Style Pasta Salad,Product Code 0 11596 52035 3 ,1/5 lb ","0 11596 52035 3 = 10/31/2013 - 11/21/2013; ;",".","1,159,754.46 total pounds, for all varieties","Garden-Fresh Foods is recalling various ready-to-eat salads, slaw, and dip products sold under various brands and codes because they may be contaminated with Listeria monocytogenes.",10/30/2013,"10/30/2013",12/11/2013,"12/11/2013"
"Food",66677,"Ongoing","Garden-Fresh Foods, Inc.","Milwaukee","WI","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","CA, IL, IN, MA, MI,MN, MO, OH, PA, WI.","F-0583-2014","Class I","Garden-Fresh Amish Country Baked Beans, Product Code, 0 11596 55186 9, 2/5 lb; ","0 11596 55186 9 = 11/4/2013 - 11/18/2013",".","1,159,754.46 total pounds, for all varieties","Garden-Fresh Foods is recalling various ready-to-eat salads, slaw, and dip products sold under various brands and codes because they may be contaminated with Listeria monocytogenes.",10/30/2013,"10/30/2013",12/11/2013,"12/11/2013"
"Food",66677,"Ongoing","Garden-Fresh Foods, Inc.","Milwaukee","WI","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","CA, IL, IN, MA, MI,MN, MO, OH, PA, WI.","F-0556-2014","Class I","Finest Traditions Robust Pasta Salad, Product Code 10 733147 10145 9 10/30/2013 - 11/18/2013 1/8 lb "," 10 733147 10145 9 = 10/30/2013 - 11/18/2013; ;",".","1,159,754.46 total pounds, for all varieties","Garden-Fresh Foods is recalling various ready-to-eat salads, slaw, and dip products sold under various brands and codes because they may be contaminated with Listeria monocytogenes.",10/30/2013,"10/30/2013",12/11/2013,"12/11/2013"
"Food",66677,"Ongoing","Garden-Fresh Foods, Inc.","Milwaukee","WI","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","CA, IL, IN, MA, MI,MN, MO, OH, PA, WI.","F-0682-2014","Class II","Farmers Market Salsa-Serrano-Spicy, 0 11596 06143 6, 6/15 oz ","0 11596 06143 6 = 11/10/2013 - 11/30/2013 ",".","1,159,754.46 total pounds, for all varieties","Garden-Fresh Foods is recalling various ready-to-eat salads, slaw, and dip products sold under various brands and codes because they may be contaminated with Listeria monocytogenes.",10/30/2013,"10/30/2013",12/11/2013,"12/11/2013"
"Food",66677,"Ongoing","Garden-Fresh Foods, Inc.","Milwaukee","WI","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","CA, IL, IN, MA, MI,MN, MO, OH, PA, WI.","F-0560-2014","Class I","Finest Traditions Rigatoni Pasta Salad, Product Code 10 733147 10148 0, 1/8 lb ","10 733147 10148 0 = 11/4/2013 - 11/20/2013 ;",".","1,159,754.46 total pounds, for all varieties","Garden-Fresh Foods is recalling various ready-to-eat salads, slaw, and dip products sold under various brands and codes because they may be contaminated with Listeria monocytogenes.",10/30/2013,"10/30/2013",12/11/2013,"12/11/2013"
"Food",66677,"Ongoing","Garden-Fresh Foods, Inc.","Milwaukee","WI","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","CA, IL, IN, MA, MI,MN, MO, OH, PA, WI.","F-0552-2014","Class I","Garden-Fresh Wheat Berry Salad,Product Code 0 11596 52118 3, 1/4 lb ","0 11596 52118 3=11/4/2013 ; ;",".","1,159,754.46 total pounds, for all varieties","Garden-Fresh Foods is recalling various ready-to-eat salads, slaw, and dip products sold under various brands and codes because they may be contaminated with Listeria monocytogenes.",10/30/2013,"10/30/2013",12/11/2013,"12/11/2013"
"Food",66677,"Ongoing","Garden-Fresh Foods, Inc.","Milwaukee","WI","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","CA, IL, IN, MA, MI,MN, MO, OH, PA, WI.","F-0486-2014","Class I","Garden-Fresh Amish Country Mustard Potato Salad, Product Code 0 11596 51015 6, 2/5 lb. . . ","11/2/2013 - 11/15/2013",".","1,159,754.46 total pounds, for all varieties","Garden-Fresh Foods is recalling various ready-to-eat salads, slaw, and dip products sold under various brands and codes because they may be contaminated with Listeria monocytogenes.",10/30/2013,"10/30/2013",12/11/2013,"12/11/2013"
"Food",66677,"Ongoing","Garden-Fresh Foods, Inc.","Milwaukee","WI","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","CA, IL, IN, MA, MI,MN, MO, OH, PA, WI.","F-0644-2014","Class I","Garden-Fresh European Style Chocolate Mousse, Product Code 0 11596 55085 5, 1/5 lb ","0 11596 55085 5= 11/1/2013 - 11/15/2013 ",".","1,159,754.46 total pounds, for all varieties","Garden-Fresh Foods is recalling various ready-to-eat salads, slaw, and dip products sold under various brands and codes because they may be contaminated with Listeria monocytogenes.",10/30/2013,"10/30/2013",12/11/2013,"12/11/2013"
"Food",66677,"Ongoing","Garden-Fresh Foods, Inc.","Milwaukee","WI","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","CA, IL, IN, MA, MI,MN, MO, OH, PA, WI.","F-0500-2014","Class I","Market Pantry Reduced Fat Potato Salad, Product Code 0 85239 20115 2, 6/16 oz. "," 0 85239 20115 2 = 11/2/2013 - 11/4/2013",".","1,159,754.46 total pounds, for all varieties","Garden-Fresh Foods is recalling various ready-to-eat salads, slaw, and dip products sold under various brands and codes because they may be contaminated with Listeria monocytogenes.",10/30/2013,"10/30/2013",12/11/2013,"12/11/2013"
"Food",66677,"Ongoing","Garden-Fresh Foods, Inc.","Milwaukee","WI","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","CA, IL, IN, MA, MI,MN, MO, OH, PA, WI.","F-0633-2014","Class I","Garden-Fresh Watergate Salad, Product Code 0 11596 85086 3 10/31/2013 - 11/28/2013 1/8 lb "," 0 11596 85086 3 = 10/31/2013 - 11/28/2013 ",".","1,159,754.46 total pounds, for all varieties","Garden-Fresh Foods is recalling various ready-to-eat salads, slaw, and dip products sold under various brands and codes because they may be contaminated with Listeria monocytogenes.",10/30/2013,"10/30/2013",12/11/2013,"12/11/2013"
"Food",66677,"Ongoing","Garden-Fresh Foods, Inc.","Milwaukee","WI","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","CA, IL, IN, MA, MI,MN, MO, OH, PA, WI.","F-0572-2014","Class I","Garden-Fresh Dixie Style Cole Slaw, Product Code 0 11596 93007 7, 2/5 lb ","0 11596 93007 7=10/30/2013 - 11/20/2013 ",".","1,159,754.46 total pounds, for all varieties","Garden-Fresh Foods is recalling various ready-to-eat salads, slaw, and dip products sold under various brands and codes because they may be contaminated with Listeria monocytogenes.",10/30/2013,"10/30/2013",12/11/2013,"12/11/2013"
"Food",66677,"Ongoing","Garden-Fresh Foods, Inc.","Milwaukee","WI","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","CA, IL, IN, MA, MI,MN, MO, OH, PA, WI.","F-0581-2014","Class I","Garden-Fresh Sweet And Sour Cucumber, Product Code 0 11596 52014 8 11/3/2013 - 11/10/2013 2/5 lb ","0 11596 52014 8 = 11/3/2013 - 11/10/2013;",".","1,159,754.46 total pounds, for all varieties","Garden-Fresh Foods is recalling various ready-to-eat salads, slaw, and dip products sold under various brands and codes because they may be contaminated with Listeria monocytogenes.",10/30/2013,"10/30/2013",12/11/2013,"12/11/2013"
"Food",66677,"Ongoing","Garden-Fresh Foods, Inc.","Milwaukee","WI","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","CA, IL, IN, MA, MI,MN, MO, OH, PA, WI.","F-0619-2014","Class I","Rogges Crab (seafood) Salad, Product Code 0 11596 55110 4, 11/1/2013 2/5 lb ","0 11596 55110 4= 11/1/2013 ",".","1,159,754.46 total pounds, for all varieties","Garden-Fresh Foods is recalling various ready-to-eat salads, slaw, and dip products sold under various brands and codes because they may be contaminated with Listeria monocytogenes.",10/30/2013,"10/30/2013",12/11/2013,"12/11/2013"
"Food",66677,"Ongoing","Garden-Fresh Foods, Inc.","Milwaukee","WI","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","CA, IL, IN, MA, MI,MN, MO, OH, PA, WI.","F-0534-2014","Class I","Garden-Fresh Asiago Pasta Salad, Product Code 0 11596 52069 8, 1/5 lb Archer Farms Asiago Pasta Salad,Product Code 0 85239 02230 6, 6/5 oz Archer Farms Asiago Pasta Salad,Product Code 0 85239 40201 6, 6/14 oz Dairy Fresh Asiago Pasta Salad, Product Code 0 70163 50041 9, 1/5 lb ","0 11596 52069 8 = 10/31/2013 - 11/20/2013; 0 85239 02230 6 = 11/3/2013; 0 85239 40201 6 = 11/3/2013 - 11/4/2013 0 70163 50041 9=10/30/2013 - 11/19/2013 ; ;",".","1,159,754.46 total pounds, for all varieties","Garden-Fresh Foods is recalling various ready-to-eat salads, slaw, and dip products sold under various brands and codes because they may be contaminated with Listeria monocytogenes.",10/30/2013,"10/30/2013",12/11/2013,"12/11/2013"
"Food",66677,"Ongoing","Garden-Fresh Foods, Inc.","Milwaukee","WI","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","CA, IL, IN, MA, MI,MN, MO, OH, PA, WI.","F-0663-2014","Class I","Archer Farms Feta & Roasted Red Pepper Dip, Product Code 0 85239 69048 2, 6/11 oz ","0 85239 69048 2 =11/4/2013 - 11/19/2013 ",".","1,159,754.46 total pounds, for all varieties","Garden-Fresh Foods is recalling various ready-to-eat salads, slaw, and dip products sold under various brands and codes because they may be contaminated with Listeria monocytogenes.",10/30/2013,"10/30/2013",12/11/2013,"12/11/2013"
"Food",66677,"Ongoing","Garden-Fresh Foods, Inc.","Milwaukee","WI","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","CA, IL, IN, MA, MI,MN, MO, OH, PA, WI.","F-0565-2014","Class I","Dairy Fresh Mexicali Pasta Salad, Product Code 0 70163 55999 8, 1/5 lb "," 0 70163 55999 8 =11/19/2013 ;",".","1,159,754.46 total pounds, for all varieties","Garden-Fresh Foods is recalling various ready-to-eat salads, slaw, and dip products sold under various brands and codes because they may be contaminated with Listeria monocytogenes.",10/30/2013,"10/30/2013",12/11/2013,"12/11/2013"
"Food",66677,"Ongoing","Garden-Fresh Foods, Inc.","Milwaukee","WI","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","CA, IL, IN, MA, MI,MN, MO, OH, PA, WI.","F-0640-2014","Class I","Garden-Fresh Pineapple Dessert, Product Code 0 11596 95050 1 11/3/2013 1/10 lb ","0 11596 95050 1 = 11/3/2013 ",".","1,159,754.46 total pounds, for all varieties","Garden-Fresh Foods is recalling various ready-to-eat salads, slaw, and dip products sold under various brands and codes because they may be contaminated with Listeria monocytogenes.",10/30/2013,"10/30/2013",12/11/2013,"12/11/2013"
"Food",66677,"Ongoing","Garden-Fresh Foods, Inc.","Milwaukee","WI","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","CA, IL, IN, MA, MI,MN, MO, OH, PA, WI.","F-0568-2014","Class I","Family Style Cole Slaw, Product Code 0 11596 53060 4 , 2/5 lb; Grandpas Cole Slaw, Product Code 0 11596 08006 2, 18/3.5oz; Grandpas Cole Slaw, Product Code 0 11596 14028 5, 12/16 oz; Grandpas Cole Slaw, Product Code 0 11596 24237 8, 8/2 lb; Grandpas Cole Slaw, Product Code 0 11596 34325 9, 4/3 lb; Grandpas Cole Slaw, Product Code 0 11596 93021 3, 2/5 lb; Market Pantry Cole Slaw, Product Code 0 85239 24106 6, 6/15 oz; Market Pantry Cole Slaw, Product Code 0 85239 24114 1, 6/44 oz; Dairy Fresh Chopped Cole Slaw,Product Code 0 70163 57363 5, 2/5 lb; Spartan Cole Slaw, Product Code 0 11213 90322 4, 6/16 oz; Marsh's Grandpas Cole Slaw, Product Code 0 11596 93021 3, 2/5 lb; Dominick's Grandpas Cole Slaw, Product Code 0 11596 14028 5, 12/16 oz ; ","0 11596 53060 4= 10/30/2013 - 11/4/2013 ; 0 11596 08006 2=11/4/2013 - 11/20/2013; 14028 5=10/31/2013 - 11/20/2013 0 11596 24237 8=11/4/2013; 0 11596 34325 9=11/4/2013 - 11/18/2013; 0 11596 93021 3=10/30/2013 - 11/18/2013; 0 85239 24106 6=10/30/2013 - 11/2 2013; 0 85239 24114 1 =11/2/2013; 0 70163 57363 5= 11/10/2013; 0 11213 90322 4= 10/31/2013 - 11/20/2013; 0 11596 93021 3 = 11/6/2013 - 11/14/2013; 0 11596 14028 5= 11/4/2013 - 11/15/2013 ",".","1,159,754.46 total pounds, for all varieties","Garden-Fresh Foods is recalling various ready-to-eat salads, slaw, and dip products sold under various brands and codes because they may be contaminated with Listeria monocytogenes.",10/30/2013,"10/30/2013",12/11/2013,"12/11/2013"
"Food",66677,"Ongoing","Garden-Fresh Foods, Inc.","Milwaukee","WI","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","CA, IL, IN, MA, MI,MN, MO, OH, PA, WI.","F-0611-2014","Class I","Finest Traditions Smoked Imitation Salmon, 10 733147 10120 6, 1/8 lb Finest Traditions Smoked Imitation Salmon 7 33147 00127 1, 6/12 oz ","10 733147 10120 6= 11/4/2013 - 11/18/2013; 7 33147 00127 1= 11/4/2013 - 11/18/2013 ",".","1,159,754.46 total pounds, for all varieties","Garden-Fresh Foods is recalling various ready-to-eat salads, slaw, and dip products sold under various brands and codes because they may be contaminated with Listeria monocytogenes.",10/30/2013,"10/30/2013",12/11/2013,"12/11/2013"
"Food",66677,"Ongoing","Garden-Fresh Foods, Inc.","Milwaukee","WI","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","CA, IL, IN, MA, MI,MN, MO, OH, PA, WI.","F-0493-2014","Class I","Garden-Fresh Reduced Fat Mustard Potato Salad, Product Code 0 11596 51202 0, 1/5 lb.; Market Pantry Reduced Fat Mustard Potato, Product Code 0 85329 20016 2, /16 oz. ","0 11596 51202 = 10/31/2013 - 11/23/2013; 0 85329 20016 2 = 1/2/2013",".","1,159,754.46 total pounds, for all varieties","Garden-Fresh Foods is recalling various ready-to-eat salads, slaw, and dip products sold under various brands and codes because they may be contaminated with Listeria monocytogenes.",10/30/2013,"10/30/2013",12/11/2013,"12/11/2013"
"Food",66677,"Ongoing","Garden-Fresh Foods, Inc.","Milwaukee","WI","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","CA, IL, IN, MA, MI,MN, MO, OH, PA, WI.","F-0660-2014","Class I","Grandpas Taco Spread, Product Code 0 11596 55910 0, 2/4 lb; Finest Traditions Taco Spread, Product Code 10 733147 11019 2, 2/4 lb "," 0 11596 55910 0 = 11/25/2013 - 12/9/2013; 10 733147 11019 2=11/4/2013 - 12/13/2013 ",".","1,159,754.46 total pounds, for all varieties","Garden-Fresh Foods is recalling various ready-to-eat salads, slaw, and dip products sold under various brands and codes because they may be contaminated with Listeria monocytogenes.",10/30/2013,"10/30/2013",12/11/2013,"12/11/2013"
"Food",66677,"Ongoing","Garden-Fresh Foods, Inc.","Milwaukee","WI","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","CA, IL, IN, MA, MI,MN, MO, OH, PA, WI.","F-0577-2014","Class I","D'Amico & Sons Smoked Paprika Rouille,Product Code 0 00 85239 10012 7 11/3/2013 - 11/8/2013 6/14 oz ","0 00 85239 10012 7 = 11/3/2013 - 11/8/2013",".","1,159,754.46 total pounds, for all varieties","Garden-Fresh Foods is recalling various ready-to-eat salads, slaw, and dip products sold under various brands and codes because they may be contaminated with Listeria monocytogenes.",10/30/2013,"10/30/2013",12/11/2013,"12/11/2013"
"Food",66677,"Ongoing","Garden-Fresh Foods, Inc.","Milwaukee","WI","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","CA, IL, IN, MA, MI,MN, MO, OH, PA, WI.","F-0529-2014","Class I","Garden-Fresh Deluxe Blt Pasta Salad,Product Code 0 11596 52039 1, 1/5 lb Finest Traditions Deluxe Blt Pasta Salad, Product Code 10 733147 10770 3 ,1/8 lb Dairy Fresh Deluxe Blt Pasta Salad, 0 70163 50074 7 11/5/2013 1/5 lb ","0 11596 52039 1 = 10/30/2013 - 11/20/2013 10 733147 10770 3 =11/4/2013 - 11/20/2013 0 70163 50074 7 =11/5/2013 ; ;",".","1,159,754.46 total pounds, for all varieties","Garden-Fresh Foods is recalling various ready-to-eat salads, slaw, and dip products sold under various brands and codes because they may be contaminated with Listeria monocytogenes.",10/30/2013,"10/30/2013",12/11/2013,"12/11/2013"
"Food",66677,"Ongoing","Garden-Fresh Foods, Inc.","Milwaukee","WI","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","CA, IL, IN, MA, MI,MN, MO, OH, PA, WI.","F-0545-2014","Class I","Garden-Fresh Italian Pasta Salad,Product Code 0 11596 92012 4, 1/8 lb ","0 11596 92012 4 = 10/31/2013 - 11/18/2013 ; ;",".","1,159,754.46 total pounds, for all varieties","Garden-Fresh Foods is recalling various ready-to-eat salads, slaw, and dip products sold under various brands and codes because they may be contaminated with Listeria monocytogenes.",10/30/2013,"10/30/2013",12/11/2013,"12/11/2013"
"Food",66677,"Ongoing","Garden-Fresh Foods, Inc.","Milwaukee","WI","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","CA, IL, IN, MA, MI,MN, MO, OH, PA, WI.","F-0562-2014","Class I","Our Own Fettuccine Pasta Salad,0 11596 52150 3 ,1/5 lb ","0 11596 52150 3 =11/7/2013 - 11/20/2013 ;",".","1,159,754.46 total pounds, for all varieties","Garden-Fresh Foods is recalling various ready-to-eat salads, slaw, and dip products sold under various brands and codes because they may be contaminated with Listeria monocytogenes.",10/30/2013,"10/30/2013",12/11/2013,"12/11/2013"
"Food",66677,"Ongoing","Garden-Fresh Foods, Inc.","Milwaukee","WI","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","CA, IL, IN, MA, MI,MN, MO, OH, PA, WI.","F-0608-2014","Class I","Garden-Fresh Seafood Pasta Salad, 0 11596 55007 7, 1/5 lb ","0 11596 55007 7= 11/1/2013 - 11/20/2013 ",".","1,159,754.46 total pounds, for all varieties","Garden-Fresh Foods is recalling various ready-to-eat salads, slaw, and dip products sold under various brands and codes because they may be contaminated with Listeria monocytogenes.",10/30/2013,"10/30/2013",12/11/2013,"12/11/2013"
"Food",66677,"Ongoing","Garden-Fresh Foods, Inc.","Milwaukee","WI","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","CA, IL, IN, MA, MI,MN, MO, OH, PA, WI.","F-0567-2014","Class I","Garden-Fresh Amish Country Cole Slaw, Product Code 0 11596 53010 9 11/4/2013 - 11/15/2013 2/5 lb ","0 11596 53010 9=11/4/2013 - 11/15/2013; ;",".","1,159,754.46 total pounds, for all varieties","Garden-Fresh Foods is recalling various ready-to-eat salads, slaw, and dip products sold under various brands and codes because they may be contaminated with Listeria monocytogenes.",10/30/2013,"10/30/2013",12/11/2013,"12/11/2013"
"Food",66677,"Ongoing","Garden-Fresh Foods, Inc.","Milwaukee","WI","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","CA, IL, IN, MA, MI,MN, MO, OH, PA, WI.","F-0495-2014","Class I","Grandpas Red Skin Potato Salad, Product Code 0 11596 14061 2 12/16 oz.; Grandpas Red Skin Potato Salad , Product Code 0 11596 51080 4, 2/5 lb. ","0 11596 14061 2= 10/31/2013 - 11/18/2013; 0 11596 51080 4 = 10/31/2013 - 11/20/2013.",".","1,159,754.46 total pounds, for all varieties","Garden-Fresh Foods is recalling various ready-to-eat salads, slaw, and dip products sold under various brands and codes because they may be contaminated with Listeria monocytogenes.",10/30/2013,"10/30/2013",12/11/2013,"12/11/2013"
"Food",66677,"Ongoing","Garden-Fresh Foods, Inc.","Milwaukee","WI","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","CA, IL, IN, MA, MI,MN, MO, OH, PA, WI.","F-0503-2014","Class I","Knowlans Mandarin Salad Base, Product Code 10 733147 10153 4, 1/8 lb ","10 733147 10153 4 = 11/4/2013 - 11/18/2013 ",".","1,159,754.46 total pounds, for all varieties","Garden-Fresh Foods is recalling various ready-to-eat salads, slaw, and dip products sold under various brands and codes because they may be contaminated with Listeria monocytogenes.",10/30/2013,"10/30/2013",12/11/2013,"12/11/2013"
"Food",66677,"Ongoing","Garden-Fresh Foods, Inc.","Milwaukee","WI","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","CA, IL, IN, MA, MI,MN, MO, OH, PA, WI.","F-0494-2014","Class I","Grandpas Deviled Egg Potato Salad, Product Code 0 11596 14012 4, 6/16 oz.; Grandpas Deviled Egg Potato Salad, Product Code 0 11596 51065 1, 2/5 lb.; Grandpas Deviled Egg Potato Salad, Product Code 0 00 11596 51068 2, 4/5 lb.; Finest Traditions Deviled Egg Potato Salad,Product Code 10 733147 10992 9, 1/8 lb; ","0 11596 14012 4 = 11/1/2013 - 11/14/2013; 0 11596 51065 1 = 10/30/2013- 11/20/2013 ; 0 00 11596 51068 2 = 10/30/2013 - 11/20/2013; 10 733147 10992 9 = 11/4/2013 - 11/6/2013.",".","1,159,754.46 total pounds, for all varieties","Garden-Fresh Foods is recalling various ready-to-eat salads, slaw, and dip products sold under various brands and codes because they may be contaminated with Listeria monocytogenes.",10/30/2013,"10/30/2013",12/11/2013,"12/11/2013"
"Food",66677,"Ongoing","Garden-Fresh Foods, Inc.","Milwaukee","WI","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","CA, IL, IN, MA, MI,MN, MO, OH, PA, WI.","F-0526-2014","Class I","Garden-Fresh Venetian Bow Tie Pasta, Product Code 0 11596 52027 8, 1/5 lb; Dairy Fresh Venetian Bow Tie Pasta, Product Code 0 11596 50042 3 ,1/5 lb","0 11596 52027 8 = 10/31/2013 - 11/14-2013; 0 11596 50042 3=10/30/2013 - 11/12/2013 ;",".","1,159,754.46 total pounds, for all varieties","Garden-Fresh Foods is recalling various ready-to-eat salads, slaw, and dip products sold under various brands and codes because they may be contaminated with Listeria monocytogenes.",10/30/2013,"10/30/2013",12/11/2013,"12/11/2013"
"Food",66677,"Ongoing","Garden-Fresh Foods, Inc.","Milwaukee","WI","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","CA, IL, IN, MA, MI,MN, MO, OH, PA, WI.","F-0537-2014","Class I","Garden-Fresh Cheese Tortellini Salad Toscana,Product Code 0 11596 52075 9, 1/5 lb ","0 11596 52075 9 = 10/31/2013 - 11/18/2013 ; ;",".","1,159,754.46 total pounds, for all varieties","Garden-Fresh Foods is recalling various ready-to-eat salads, slaw, and dip products sold under various brands and codes because they may be contaminated with Listeria monocytogenes.",10/30/2013,"10/30/2013",12/11/2013,"12/11/2013"
"Food",66677,"Ongoing","Garden-Fresh Foods, Inc.","Milwaukee","WI","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","CA, IL, IN, MA, MI,MN, MO, OH, PA, WI.","F-0543-2014","Class I","Garden-Fresh Whole Grain Garden Pepper Pasta Salad,Product Code 0 11596 52207 4, 1/5 lb ","0 11596 52207 4 = 11/1/2013 -11/15/2013 ; ;",".","1,159,754.46 total pounds, for all varieties","Garden-Fresh Foods is recalling various ready-to-eat salads, slaw, and dip products sold under various brands and codes because they may be contaminated with Listeria monocytogenes.",10/30/2013,"10/30/2013",12/11/2013,"12/11/2013"
"Food",66677,"Ongoing","Garden-Fresh Foods, Inc.","Milwaukee","WI","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","CA, IL, IN, MA, MI,MN, MO, OH, PA, WI.","F-0479-2014","Class I","Garden-Fresh Red Potato & Spinach Salad, Product Code 0 11596 52140 4, 5 lb. ","10/30/2013 - 11/20/2013",".","1,159,754.46 total pounds, for all varieties","Garden-Fresh Foods is recalling various ready-to-eat salads, slaw, and dip products sold under various brands and codes because they may be contaminated with Listeria monocytogenes.",10/30/2013,"10/30/2013",12/11/2013,"12/11/2013"
"Food",66677,"Ongoing","Garden-Fresh Foods, Inc.","Milwaukee","WI","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","CA, IL, IN, MA, MI,MN, MO, OH, PA, WI.","F-0555-2014","Class I","Finest Traditions Ties & Tomatoes Pasta Salad,10 733147 10686 7, 1/8 lb ","10 733147 10686 7= 11/4/2013 - 11/18/2013; ;",".","1,159,754.46 total pounds, for all varieties","Garden-Fresh Foods is recalling various ready-to-eat salads, slaw, and dip products sold under various brands and codes because they may be contaminated with Listeria monocytogenes.",10/30/2013,"10/30/2013",12/11/2013,"12/11/2013"
"Food",66677,"Ongoing","Garden-Fresh Foods, Inc.","Milwaukee","WI","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","CA, IL, IN, MA, MI,MN, MO, OH, PA, WI.","F-0686-2014","Class I","Garden-Fresh Health Salad, Product Code 0 11 11596 82114 2, 1/8 lb ","0 11 11596 82114 2 = 10/30/2013 - 11/19/2013 ",".","1,159,754.46 total pounds, for all varieties","Garden-Fresh Foods is recalling various ready-to-eat salads, slaw, and dip products sold under various brands and codes because they may be contaminated with Listeria monocytogenes.",10/30/2013,"10/30/2013",12/11/2013,"12/11/2013"
"Food",66677,"Ongoing","Garden-Fresh Foods, Inc.","Milwaukee","WI","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","CA, IL, IN, MA, MI,MN, MO, OH, PA, WI.","F-0628-2014","Class I","Garden-Fresh Sun Garden Salad, Product Code 0 11596 42059 2, 1/4 lb ","0 11596 42059 2 =10/30/2013 - 11/15/2013 ",".","1,159,754.46 total pounds, for all varieties","Garden-Fresh Foods is recalling various ready-to-eat salads, slaw, and dip products sold under various brands and codes because they may be contaminated with Listeria monocytogenes.",10/30/2013,"10/30/2013",12/11/2013,"12/11/2013"
"Food",66677,"Ongoing","Garden-Fresh Foods, Inc.","Milwaukee","WI","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","CA, IL, IN, MA, MI,MN, MO, OH, PA, WI.","F-0496-2014","Class I","Grandpas Potato Salad, Product Code 0 11596 08005 5, 18/3.5oz.; Grandpas Potato Salad, Product Code 0 11596 14027 8, 12/16 oz.; Grandpas Potato Salad, Product Code 0 11596 24227 9, 8/2 lb.; Grandpas Potato Salad, Product Code 0 11596 34326 6, 4/3 lb.; Grandpas Potato Salad , Product Code 0 11596 91026 0, 2/5 lb. Weis Original Potato Salad, Product Code 0 41497 05838 9, 12/16 oz; Weis Original Potato Salad, Product Code 0 41497 05900 3, 4/3 lb; Weis Original Potato Salad, Product Code 0 11596 51102 3, 2/5 lb.; Spoon River Potato Salad, Product Code 0 11596 51032 3, 3 2/5 lb; Dominick's Grandpas Potato Salad , Product Code 0 11596 14027 8, 12/16 oz; Family Style Potato Salad, 0 11596 51061 3, 2/5 lb ","0 11596 08005 5 = 11/5/2013 - 11/19/2013; 0 11596 14027 8 = 11/4/2013 - 11/20/2013; 0 11596 24227 9 = 11/2/2013; 0 11596 34326 6 = 11/5/2013 - 11/20/2013; 0 11596 91026 0 = 10/31/2013 - 11/20/2013. 0 41497 05838 9 = 10/30/2013 - 11/19/2013; 0 41497 05900 3 = 11/1/2013 - 11/19/2013; 0 11596 51102 3 = 11/1/2013 - 11/15/2013; 0 11596 51032 3 = 10/31/2013 - 11/20/2013; 0 11596 14027 8 =11/6/2013 - 11/18/2013; 0 11596 51061 3 =11/1/2013 - 11/20/2013 ",".","1,159,754.46 total pounds, for all varieties","Garden-Fresh Foods is recalling various ready-to-eat salads, slaw, and dip products sold under various brands and codes because they may be contaminated with Listeria monocytogenes.",10/30/2013,"10/30/2013",12/11/2013,"12/11/2013"
"Food",66677,"Ongoing","Garden-Fresh Foods, Inc.","Milwaukee","WI","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","CA, IL, IN, MA, MI,MN, MO, OH, PA, WI.","F-0595-2014","Class I","Garden-Fresh Deluxe Egg Salad,Product Code 0 11596 52043 8, 1/5 lb; Chefs Kitchen Deluxe Egg Salad, 0 11596 52044 5, 1/5 lb "," 0 11596 52043 8= 10/30/2013 - 11/123/2013; 0 11596 52044 5 =10/30/2013 - 11/14/2013",".","1,159,754.46 total pounds, for all varieties","Garden-Fresh Foods is recalling various ready-to-eat salads, slaw, and dip products sold under various brands and codes because they may be contaminated with Listeria monocytogenes.",10/30/2013,"10/30/2013",12/11/2013,"12/11/2013"
"Food",66677,"Ongoing","Garden-Fresh Foods, Inc.","Milwaukee","WI","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","CA, IL, IN, MA, MI,MN, MO, OH, PA, WI.","F-0685-2014","Class II","Martins White French Dressing , Product Code 0 11596 55350 4, 4/2 lb ","0 11596 55350 4 = 11/1/2013 - 11/15/2013 ",".","1,159,754.46 total pounds, for all varieties","Garden-Fresh Foods is recalling various ready-to-eat salads, slaw, and dip products sold under various brands and codes because they may be contaminated with Listeria monocytogenes.",10/30/2013,"10/30/2013",12/11/2013,"12/11/2013"
"Food",66677,"Ongoing","Garden-Fresh Foods, Inc.","Milwaukee","WI","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","CA, IL, IN, MA, MI,MN, MO, OH, PA, WI.","F-0492-2014","Class I","Garden- Fresh Steakhouse Potato Salad Kit, Product Code 0 11596 51076 7, 1/10.75lb. ","10-30-2013 ",".","1,159,754.46 total pounds, for all varieties","Garden-Fresh Foods is recalling various ready-to-eat salads, slaw, and dip products sold under various brands and codes because they may be contaminated with Listeria monocytogenes.",10/30/2013,"10/30/2013",12/11/2013,"12/11/2013"
"Food",66677,"Ongoing","Garden-Fresh Foods, Inc.","Milwaukee","WI","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","CA, IL, IN, MA, MI,MN, MO, OH, PA, WI.","F-0650-2014","Class I","Finest Traditions Pistachio Whip, Product Code 10 733147 00020 ,1/8 lb ","10 733147 00020 2 = 11/4/2013 ",".","1,159,754.46 total pounds, for all varieties","Garden-Fresh Foods is recalling various ready-to-eat salads, slaw, and dip products sold under various brands and codes because they may be contaminated with Listeria monocytogenes.",10/30/2013,"10/30/2013",12/11/2013,"12/11/2013"
"Food",66677,"Ongoing","Garden-Fresh Foods, Inc.","Milwaukee","WI","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","CA, IL, IN, MA, MI,MN, MO, OH, PA, WI.","F-0549-2014","Class I","Garden-Fresh Spinach Pasta Salad Base, Product Code 0 11596 62072 5,1/5.25lb "," 0 11596 62072 5 = 10/30/2013 - 11/20/2013 ; ;",".","1,159,754.46 total pounds, for all varieties","Garden-Fresh Foods is recalling various ready-to-eat salads, slaw, and dip products sold under various brands and codes because they may be contaminated with Listeria monocytogenes.",10/30/2013,"10/30/2013",12/11/2013,"12/11/2013"
"Food",66677,"Ongoing","Garden-Fresh Foods, Inc.","Milwaukee","WI","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","CA, IL, IN, MA, MI,MN, MO, OH, PA, WI.","F-0548-2014","Class I","Garden-Fresh Minestrone Salad, Product Code 0 11596 52085 8, 1/5 lb ","0 11596 52085 8 = 10/29/2013 - 11/20/2013 ; ;",".","1,159,754.46 total pounds, for all varieties","Garden-Fresh Foods is recalling various ready-to-eat salads, slaw, and dip products sold under various brands and codes because they may be contaminated with Listeria monocytogenes.",10/30/2013,"10/30/2013",12/11/2013,"12/11/2013"
"Food",66677,"Ongoing","Garden-Fresh Foods, Inc.","Milwaukee","WI","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","CA, IL, IN, MA, MI,MN, MO, OH, PA, WI.","F-0553-2014","Class I","Weis Spiral Pasta Salad, 0 11596 52107 7, 1/5 lb ","0 11596 52107 7 =10/30/2013 - 11/20/2013 ; ;",".","1,159,754.46 total pounds, for all varieties","Garden-Fresh Foods is recalling various ready-to-eat salads, slaw, and dip products sold under various brands and codes because they may be contaminated with Listeria monocytogenes.",10/30/2013,"10/30/2013",12/11/2013,"12/11/2013"
"Food",66677,"Ongoing","Garden-Fresh Foods, Inc.","Milwaukee","WI","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","CA, IL, IN, MA, MI,MN, MO, OH, PA, WI.","F-0550-2014","Class I","Garden-Fresh Parmesan Peppercorn Pasta Salad Base, Product Code 0 11596 52086 5, 1/5 lb "," 0 11596 52086 5 = 11/1/2013 - 11/15/2013 ; ;",".","1,159,754.46 total pounds, for all varieties","Garden-Fresh Foods is recalling various ready-to-eat salads, slaw, and dip products sold under various brands and codes because they may be contaminated with Listeria monocytogenes.",10/30/2013,"10/30/2013",12/11/2013,"12/11/2013"
"Food",66677,"Ongoing","Garden-Fresh Foods, Inc.","Milwaukee","WI","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","CA, IL, IN, MA, MI,MN, MO, OH, PA, WI.","F-0639-2014","Class I","Garden-Fresh Pumpking Bread Pudding, Product Code 0 11596 75036 1,2013 1/7 lb Garden-Fresh Pumpkin Bread Pudding, Product Code 0 11596 07036 0, 6/12 oz ","0 11596 75036 1= 10/30/2013 - 11/20/2013; 0 11596 07036 0= 10/30/2013 - 11/20/2013 ",".","1,159,754.46 total pounds, for all varieties","Garden-Fresh Foods is recalling various ready-to-eat salads, slaw, and dip products sold under various brands and codes because they may be contaminated with Listeria monocytogenes.",10/30/2013,"10/30/2013",12/11/2013,"12/11/2013"
"Food",66677,"Ongoing","Garden-Fresh Foods, Inc.","Milwaukee","WI","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","CA, IL, IN, MA, MI,MN, MO, OH, PA, WI.","F-0646-2014","Class I","Cranberry Apple Relish, Product Code 0 11596 155097 8, 1/5 lb ","0 11596 155097 8=11/4/2013 -11/30/2013 ",".","1,159,754.46 total pounds, for all varieties","Garden-Fresh Foods is recalling various ready-to-eat salads, slaw, and dip products sold under various brands and codes because they may be contaminated with Listeria monocytogenes.",10/30/2013,"10/30/2013",12/11/2013,"12/11/2013"
"Food",66677,"Ongoing","Garden-Fresh Foods, Inc.","Milwaukee","WI","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","CA, IL, IN, MA, MI,MN, MO, OH, PA, WI.","F-0525-2014","Class I","Garden-Fresh Caprese Pasta Salad Kit,Product Code 0 11 11596 52701 3, 1/5 lb ","0 11 11596 52701 3 = 11/1/2013 - 11/6/2013;",".","1,159,754.46 total pounds, for all varieties","Garden-Fresh Foods is recalling various ready-to-eat salads, slaw, and dip products sold under various brands and codes because they may be contaminated with Listeria monocytogenes.",10/30/2013,"10/30/2013",12/11/2013,"12/11/2013"
"Food",66677,"Ongoing","Garden-Fresh Foods, Inc.","Milwaukee","WI","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","CA, IL, IN, MA, MI,MN, MO, OH, PA, WI.","F-0540-2014","Class I","Garden-Fresh Spaghetti Salad, Product Code 0 11 11596 52130 1, 1/5 lb ","0 11 11596 52130 1= 10/30/2013 - 11/20/2013 ; ;",".","1,159,754.46 total pounds, for all varieties","Garden-Fresh Foods is recalling various ready-to-eat salads, slaw, and dip products sold under various brands and codes because they may be contaminated with Listeria monocytogenes.",10/30/2013,"10/30/2013",12/11/2013,"12/11/2013"
"Food",66677,"Ongoing","Garden-Fresh Foods, Inc.","Milwaukee","WI","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","CA, IL, IN, MA, MI,MN, MO, OH, PA, WI.","F-0551-2014","Class I","Garden-Fresh Quinoa Energy Salad, Product Code 0 11596 , 1/4 lb "," 0 11596 82074 3 = 11/20/2013 ; ;",".","1,159,754.46 total pounds, for all varieties","Garden-Fresh Foods is recalling various ready-to-eat salads, slaw, and dip products sold under various brands and codes because they may be contaminated with Listeria monocytogenes.",10/30/2013,"10/30/2013",12/11/2013,"12/11/2013"
"Food",66677,"Ongoing","Garden-Fresh Foods, Inc.","Milwaukee","WI","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","CA, IL, IN, MA, MI,MN, MO, OH, PA, WI.","F-0589-2014","Class I","Grandpas Baked Beans, Product Code 0 11596 55180 7, 2/5 lb ","11596 55180 7 = 10/31/2013 - 11/18/2013 ",".","1,159,754.46 total pounds, for all varieties","Garden-Fresh Foods is recalling various ready-to-eat salads, slaw, and dip products sold under various brands and codes because they may be contaminated with Listeria monocytogenes.",10/30/2013,"10/30/2013",12/11/2013,"12/11/2013"
"Food",66677,"Ongoing","Garden-Fresh Foods, Inc.","Milwaukee","WI","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","CA, IL, IN, MA, MI,MN, MO, OH, PA, WI.","F-0531-2014","Class I","Garden-Fresh Sweet Bow Tie Pasta With Bacon,Product Code 0 11 11596 52047 2, 1/5 lb Lipari Old Tyme Sweet Bow Tie Pasta With Bacon, Product Code 0 94776 03409 3, 1/5 lb ","0 11 11596 52047 2 = 10/30/2013 - 11/20/2013; 0 94776 03409 3 = 10/30/2013 - 11/20/2013; ; ;",".","1,159,754.46 total pounds, for all varieties","Garden-Fresh Foods is recalling various ready-to-eat salads, slaw, and dip products sold under various brands and codes because they may be contaminated with Listeria monocytogenes.",10/30/2013,"10/30/2013",12/11/2013,"12/11/2013"
"Food",66677,"Ongoing","Garden-Fresh Foods, Inc.","Milwaukee","WI","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","CA, IL, IN, MA, MI,MN, MO, OH, PA, WI.","F-0614-2014","Class I","Garden-Fresh Fantastic Seafood Kit, Product Code 0 11596, 2/5 lb ","0 11596 95104 1 = 11/4/2013 - 11/5/2013 ",".","1,159,754.46 total pounds, for all varieties","Garden-Fresh Foods is recalling various ready-to-eat salads, slaw, and dip products sold under various brands and codes because they may be contaminated with Listeria monocytogenes.",10/30/2013,"10/30/2013",12/11/2013,"12/11/2013"
"Food",66677,"Ongoing","Garden-Fresh Foods, Inc.","Milwaukee","WI","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","CA, IL, IN, MA, MI,MN, MO, OH, PA, WI.","F-0605-2014","Class I","Garden-Fresh Seafood Salad, 0 11596 55102 9, 1/5 lb; ","0 11596 55102 9 = 11/6/2013 - 11/23/2013",".","1,159,754.46 total pounds, for all varieties","Garden-Fresh Foods is recalling various ready-to-eat salads, slaw, and dip products sold under various brands and codes because they may be contaminated with Listeria monocytogenes.",10/30/2013,"10/30/2013",12/11/2013,"12/11/2013"
"Food",66677,"Ongoing","Garden-Fresh Foods, Inc.","Milwaukee","WI","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","CA, IL, IN, MA, MI,MN, MO, OH, PA, WI.","F-0483-2014","Class I","Garden-Fresh Red Potato Salad, Product Code 0 11596 24205 7, 8/2 lb. Weis Red Potato Salad, Product Code 0 41497 05848 8, 6/16 oz. . "," 0 11596 24205 7 = 11/19/2013; 0 41497 05848 8 = 10/31/2013 - 11/19/2013. ",".","1,159,754.46 total pounds, for all varieties","Garden-Fresh Foods is recalling various ready-to-eat salads, slaw, and dip products sold under various brands and codes because they may be contaminated with Listeria monocytogenes.",10/30/2013,"10/30/2013",12/11/2013,"12/11/2013"
"Food",66677,"Ongoing","Garden-Fresh Foods, Inc.","Milwaukee","WI","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","CA, IL, IN, MA, MI,MN, MO, OH, PA, WI.","F-0676-2014","Class II","Grandpas Fresh Salsa Hot & Spicy, 5914, 1/5 lb ","5914 = 11/23/2013 ",".","1,159,754.46 total pounds, for all varieties","Garden-Fresh Foods is recalling various ready-to-eat salads, slaw, and dip products sold under various brands and codes because they may be contaminated with Listeria monocytogenes.",10/30/2013,"10/30/2013",12/11/2013,"12/11/2013"
"Food",66677,"Ongoing","Garden-Fresh Foods, Inc.","Milwaukee","WI","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","CA, IL, IN, MA, MI,MN, MO, OH, PA, WI.","F-0539-2014","Class I","Garden-Fresh Whole Wheat Pasta With Sun Dried Tomatoes,Product Code 0 11596 52094 0 ,1/5 lb ","0 11596 52094 0 = 10/30/2013 - 11/17/2013 ; ;",".","1,159,754.46 total pounds, for all varieties","Garden-Fresh Foods is recalling various ready-to-eat salads, slaw, and dip products sold under various brands and codes because they may be contaminated with Listeria monocytogenes.",10/30/2013,"10/30/2013",12/11/2013,"12/11/2013"
"Food",66677,"Ongoing","Garden-Fresh Foods, Inc.","Milwaukee","WI","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","CA, IL, IN, MA, MI,MN, MO, OH, PA, WI.","F-0651-2014","Class I","Finest Traditions Cookies & Creme Dessert, Product Code 10 733147 00022 6, 1/8 lb ","10 733147 00022 6 = 11/4/2013 ",".","1,159,754.46 total pounds, for all varieties","Garden-Fresh Foods is recalling various ready-to-eat salads, slaw, and dip products sold under various brands and codes because they may be contaminated with Listeria monocytogenes.",10/30/2013,"10/30/2013",12/11/2013,"12/11/2013"
"Food",66677,"Ongoing","Garden-Fresh Foods, Inc.","Milwaukee","WI","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","CA, IL, IN, MA, MI,MN, MO, OH, PA, WI.","F-0596-2014","Class I","Garden-Fresh Deviled Egg Salad, Product Code 0 11596 52122, 1/5 lb; ","0 11596 52122 0 = 11/6/2013 - 11/13/2013;",".","1,159,754.46 total pounds, for all varieties","Garden-Fresh Foods is recalling various ready-to-eat salads, slaw, and dip products sold under various brands and codes because they may be contaminated with Listeria monocytogenes.",10/30/2013,"10/30/2013",12/11/2013,"12/11/2013"
"Food",66677,"Ongoing","Garden-Fresh Foods, Inc.","Milwaukee","WI","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","CA, IL, IN, MA, MI,MN, MO, OH, PA, WI.","F-0641-2014","Class I","Garden-Fresh Pumpkin Mousse, Product Code 0 11596 55053 4, 1/5 lb; Finest Traditions Pumpkin Mousse, Product Code 0 00 11596 55053 4 10/30/2013 - 11/13/2013 1/5 lb ","0 11596 55053 4 = 10/30/2013 - 11/15/2013; 0 00 11596 55053 4 = 10/30/2013 - 11/13/2013 ",".","1,159,754.46 total pounds, for all varieties","Garden-Fresh Foods is recalling various ready-to-eat salads, slaw, and dip products sold under various brands and codes because they may be contaminated with Listeria monocytogenes.",10/30/2013,"10/30/2013",12/11/2013,"12/11/2013"
"Food",66677,"Ongoing","Garden-Fresh Foods, Inc.","Milwaukee","WI","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","CA, IL, IN, MA, MI,MN, MO, OH, PA, WI.","F-0623-2014","Class I","Garden-Fresh Seven Layer Salad Kit, Product Code 0 11596 85161 7, 2/3.25lb ","0 11596 85161 7= 11/1/2013 - 11/29/2013 ",".","1,159,754.46 total pounds, for all varieties","Garden-Fresh Foods is recalling various ready-to-eat salads, slaw, and dip products sold under various brands and codes because they may be contaminated with Listeria monocytogenes.",10/30/2013,"10/30/2013",12/11/2013,"12/11/2013"
"Food",66677,"Ongoing","Garden-Fresh Foods, Inc.","Milwaukee","WI","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","CA, IL, IN, MA, MI,MN, MO, OH, PA, WI.","F-0582-2014","Class I","Grandpas Sour Cream Cucumber Salad, Product Code 0 11596 52080 3, 2/5 lb ","11596 52080 3= 11/5/2013 - 11/9/2013",".","1,159,754.46 total pounds, for all varieties","Garden-Fresh Foods is recalling various ready-to-eat salads, slaw, and dip products sold under various brands and codes because they may be contaminated with Listeria monocytogenes.",10/30/2013,"10/30/2013",12/11/2013,"12/11/2013"
"Food",66677,"Ongoing","Garden-Fresh Foods, Inc.","Milwaukee","WI","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","CA, IL, IN, MA, MI,MN, MO, OH, PA, WI.","F-0506-2014","Class I","Rogges White Potato Salad, Product Code 0 11596 51052 1, 2/5 lb ","0 11596 51052 1 = 11/2/2013;",".","1,159,754.46 total pounds, for all varieties","Garden-Fresh Foods is recalling various ready-to-eat salads, slaw, and dip products sold under various brands and codes because they may be contaminated with Listeria monocytogenes.",10/30/2013,"10/30/2013",12/11/2013,"12/11/2013"
"Food",66677,"Ongoing","Garden-Fresh Foods, Inc.","Milwaukee","WI","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","CA, IL, IN, MA, MI,MN, MO, OH, PA, WI.","F-0684-2014","Class II","Our Own Fresh Salsa, Product Code 0 11596 59021 9 , 1/5 lb "," 0 11596 59021 9 = 11/7/2013 - 11/19/2013 ",".","1,159,754.46 total pounds, for all varieties","Garden-Fresh Foods is recalling various ready-to-eat salads, slaw, and dip products sold under various brands and codes because they may be contaminated with Listeria monocytogenes.",10/30/2013,"10/30/2013",12/11/2013,"12/11/2013"
"Food",66677,"Ongoing","Garden-Fresh Foods, Inc.","Milwaukee","WI","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","CA, IL, IN, MA, MI,MN, MO, OH, PA, WI.","F-0678-2014","Class II","Grandpas Fresh Mango Salsa, 5916, 1/5 lb "," 5916 = 11/1/2013 - 11/30/2013 ",".","1,159,754.46 total pounds, for all varieties","Garden-Fresh Foods is recalling various ready-to-eat salads, slaw, and dip products sold under various brands and codes because they may be contaminated with Listeria monocytogenes.",10/30/2013,"10/30/2013",12/11/2013,"12/11/2013"
"Food",66677,"Ongoing","Garden-Fresh Foods, Inc.","Milwaukee","WI","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","CA, IL, IN, MA, MI,MN, MO, OH, PA, WI.","F-0517-2014","Class I","Family Style Macaroni Salad, Product Code 0 11596 52060 5, 2/5 lb; Garden-Fresh Macaroni Salad,Product Code 0 11596 52005 6, 2/5 lb; Garden-Fresh Macaroni Salad, Product Code 0 11596 14018 6, 12/16 oz; Garden-Fresh Macaroni Salad, Product Code 0 11596 24210 1, 8/2 lb; Garden-Fresh Macaroni Salad, Product Code 0 11596 34305 1, 6/3 lb; Grandpas Macaroni Salad, Product Code 0 11596 14066 7, 12/16 oz; Grandpas Macaroni Salad, Product Code 0 11596 52066 7, 2/5 lb; Weis Original Macaroni Salad,Product Code 0 41497 05839 6, 12/16 oz; Weis Original Macaroni Salad, Product Code 0 41497 05904 1, 4/3 lb; Weis Original Macaroni Salad, Product Code 0 11596 52106 0, 2/5 lb; Finest Traditions Macaroni Salad, Product Code 10 733147 10286 9, 1/8 lb; Finest Traditions Macaroni Salad, Product Code 7 33147 00018 2, 6/16 oz; Rogges Macaroni Salad, Product Code 0 11596 52019 3, 2/5 lb; Dairy Fresh Macaroni Salad, Product Code 0 70163 56415 2, 2/5 lb; Spartan Macaroni Salad, Product Code 0 11213 90321 7, 6/16 oz; Market Pantry Macaroni Salad, Product Code 0 85239 24105 9, 6/16 oz. ","0 11596 52060 5 = 10/30/2013 - 11/20/2013; 0 11596 52005 6 = 10/30/2013 - 11/20/2013; 0 11596 14018 6 = 11/1/2013 - 11/18/2013; 11596 24210 1 = 11/15/2013; 0 11596 34305 1 = 11/1/2013 - 11/20/2013; 0 11596 14066 7 = 10/30/2013; 0 11596 52066 7 = 11/5/2013; 0 41497 05839 6 = 10/30/2013 - 11/19/2013; 0 41497 05904 1 = 11/1/2013 - 11/19/2013; 0 11596 52106 0 = 10/30/2013 - 11/15/2013; 10 733147 10286 9 = 10/30/2013 - 11/13/2013; 7 33147 00018 2 = 10/30/2013 - 11/18/2013; 0 11596 52019 3 = 11/4/2013; 0 70163 56415 2 = 11/18/2013; 0 85239 24105 9=10/30/2013 0 11213 90321 7 = 10/31/2013 - 11/20/2013; ",".","1,159,754.46 total pounds, for all varieties","Garden-Fresh Foods is recalling various ready-to-eat salads, slaw, and dip products sold under various brands and codes because they may be contaminated with Listeria monocytogenes.",10/30/2013,"10/30/2013",12/11/2013,"12/11/2013"
"Food",66677,"Ongoing","Garden-Fresh Foods, Inc.","Milwaukee","WI","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","CA, IL, IN, MA, MI,MN, MO, OH, PA, WI.","F-0512-2014","Class I","Our Own Homestyle Mustard Potato Salad, Product Code 0 11596 51047 7, 4/5 lb; ; "," 0 11596 51047 7 = 10/30/2013 - 11/15/2013;",".","1,159,754.46 total pounds, for all varieties","Garden-Fresh Foods is recalling various ready-to-eat salads, slaw, and dip products sold under various brands and codes because they may be contaminated with Listeria monocytogenes.",10/30/2013,"10/30/2013",12/11/2013,"12/11/2013"
"Food",66677,"Ongoing","Garden-Fresh Foods, Inc.","Milwaukee","WI","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","CA, IL, IN, MA, MI,MN, MO, OH, PA, WI.","F-0681-2014","Class II","Farmers Market Salsa- Jalapeno - Mild, 0 11596 06142 9, 6/15 oz ","0 11596 06142 9 = 11/10/2013 - 11/30/2013 ",".","1,159,754.46 total pounds, for all varieties","Garden-Fresh Foods is recalling various ready-to-eat salads, slaw, and dip products sold under various brands and codes because they may be contaminated with Listeria monocytogenes.",10/30/2013,"10/30/2013",12/11/2013,"12/11/2013"
"Food",66677,"Ongoing","Garden-Fresh Foods, Inc.","Milwaukee","WI","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","CA, IL, IN, MA, MI,MN, MO, OH, PA, WI.","F-0637-2014","Class I","Garden-Fresh Baked Egg Custard, Product Code 0 11596 07032 2, 6/12 oz ","0 11596 07032 2 = 10/30/2013 - 11/20/2013 ",".","1,159,754.46 total pounds, for all varieties","Garden-Fresh Foods is recalling various ready-to-eat salads, slaw, and dip products sold under various brands and codes because they may be contaminated with Listeria monocytogenes.",10/30/2013,"10/30/2013",12/11/2013,"12/11/2013"
"Food",66677,"Ongoing","Garden-Fresh Foods, Inc.","Milwaukee","WI","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","CA, IL, IN, MA, MI,MN, MO, OH, PA, WI.","F-0649-2014","Class I","Finest Traditions Strawberry Creme Delight, Product Code 10 733147 00021 9, 1/8 lb ","10 733147 00021 9 = 10/30/2013 - 11/4/2013 ",".","1,159,754.46 total pounds, for all varieties","Garden-Fresh Foods is recalling various ready-to-eat salads, slaw, and dip products sold under various brands and codes because they may be contaminated with Listeria monocytogenes.",10/30/2013,"10/30/2013",12/11/2013,"12/11/2013"
"Food",66677,"Ongoing","Garden-Fresh Foods, Inc.","Milwaukee","WI","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","CA, IL, IN, MA, MI,MN, MO, OH, PA, WI.","F-0557-2014","Class I","Finest Traditions Penne Pasta With Roma, Product Code 10 733147 10286 9, 1/8 lb "," 10 733147 10286 9 = 10/30/2013 - 11/20/2013; ;",".","1,159,754.46 total pounds, for all varieties","Garden-Fresh Foods is recalling various ready-to-eat salads, slaw, and dip products sold under various brands and codes because they may be contaminated with Listeria monocytogenes.",10/30/2013,"10/30/2013",12/11/2013,"12/11/2013"
"Food",66677,"Ongoing","Garden-Fresh Foods, Inc.","Milwaukee","WI","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","CA, IL, IN, MA, MI,MN, MO, OH, PA, WI.","F-0584-2014","Class I","Garden-Fresh Black Bean Couscous, Product Code 0 11596 55620 8, 1/5 lb ","0 11596 55620 8 =11/5/2013 - 11/13/2013",".","1,159,754.46 total pounds, for all varieties","Garden-Fresh Foods is recalling various ready-to-eat salads, slaw, and dip products sold under various brands and codes because they may be contaminated with Listeria monocytogenes.",10/30/2013,"10/30/2013",12/11/2013,"12/11/2013"
"Food",66677,"Ongoing","Garden-Fresh Foods, Inc.","Milwaukee","WI","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","CA, IL, IN, MA, MI,MN, MO, OH, PA, WI.","F-0674-2014","Class II","Garden-Fresh Creamy Cole Slaw Dressing, 0 11596 43200 7, 4/2 lb ","0 11596 43200 7 = 11/8/2013 - 12/14/2013 ",".","1,159,754.46 total pounds, for all varieties","Garden-Fresh Foods is recalling various ready-to-eat salads, slaw, and dip products sold under various brands and codes because they may be contaminated with Listeria monocytogenes.",10/30/2013,"10/30/2013",12/11/2013,"12/11/2013"
"Food",66677,"Ongoing","Garden-Fresh Foods, Inc.","Milwaukee","WI","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","CA, IL, IN, MA, MI,MN, MO, OH, PA, WI.","F-0657-2014","Class I","Grandpa Vegetable Bagel Spread, Product Code 0 11596 55905 6, 1/5 lb ","0 11596 55905 6 = 11/2/2013 - 11/15/2013 ",".","1,159,754.46 total pounds, for all varieties","Garden-Fresh Foods is recalling various ready-to-eat salads, slaw, and dip products sold under various brands and codes because they may be contaminated with Listeria monocytogenes.",10/30/2013,"10/30/2013",12/11/2013,"12/11/2013"
"Food",66677,"Ongoing","Garden-Fresh Foods, Inc.","Milwaukee","WI","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","CA, IL, IN, MA, MI,MN, MO, OH, PA, WI.","F-0642-2014","Class I","Garden-Fresh Cookies & Creme Mousse, Product Code 0 11596 55062 6, 1/5 lb "," 0 11596 55062 6 = 11/11/2013 - 11/20/2013 ",".","1,159,754.46 total pounds, for all varieties","Garden-Fresh Foods is recalling various ready-to-eat salads, slaw, and dip products sold under various brands and codes because they may be contaminated with Listeria monocytogenes.",10/30/2013,"10/30/2013",12/11/2013,"12/11/2013"
"Food",66677,"Ongoing","Garden-Fresh Foods, Inc.","Milwaukee","WI","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","CA, IL, IN, MA, MI,MN, MO, OH, PA, WI.","F-0643-2014","Class I","Garden-Fresh Mint Chocolate Chip Cookie Mousse, Product Code 0 11596 55069 5, 1/5 lb ","0 11596 55069 5 = 11/1/2013 - 11/20/2013 ",".","1,159,754.46 total pounds, for all varieties","Garden-Fresh Foods is recalling various ready-to-eat salads, slaw, and dip products sold under various brands and codes because they may be contaminated with Listeria monocytogenes.",10/30/2013,"10/30/2013",12/11/2013,"12/11/2013"
"Food",66677,"Ongoing","Garden-Fresh Foods, Inc.","Milwaukee","WI","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","CA, IL, IN, MA, MI,MN, MO, OH, PA, WI.","F-0522-2014","Class I","Dairy Fresh Homemade Macaroni Salad, Product Code 0 70163 89080 0, 2/5 lb ","0 70163 89080 0 = 11/3/2013 - 11/17/2013; ",".","1,159,754.46 total pounds, for all varieties","Garden-Fresh Foods is recalling various ready-to-eat salads, slaw, and dip products sold under various brands and codes because they may be contaminated with Listeria monocytogenes.",10/30/2013,"10/30/2013",12/11/2013,"12/11/2013"
"Food",66677,"Ongoing","Garden-Fresh Foods, Inc.","Milwaukee","WI","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","CA, IL, IN, MA, MI,MN, MO, OH, PA, WI.","F-0598-2014","Class I","Garden-Fresh Egg Salad Spread, Product Code 0 11596 55168 5, 1/5 lb; Finest Traditions Egg Salad Spread, Product Code 10 733147 10189 3, 2/4 lb; Finest Traditions Egg Salad Spread,Product Code 7 33147 10491 0, 6/12 oz; ","0 11596 55168 5= 11/1/2013 - 11/15/2013; 10 733147 10189 3 = 10/30/2013 - 11/13/2013; 7 33147 10491 0 = 10/30/2013 - 11/20/2013 ",".","1,159,754.46 total pounds, for all varieties","Garden-Fresh Foods is recalling various ready-to-eat salads, slaw, and dip products sold under various brands and codes because they may be contaminated with Listeria monocytogenes.",10/30/2013,"10/30/2013",12/11/2013,"12/11/2013"
"Food",66677,"Ongoing","Garden-Fresh Foods, Inc.","Milwaukee","WI","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","CA, IL, IN, MA, MI,MN, MO, OH, PA, WI.","F-0490-2014","Class I","Knowlans Club Salad Base, Product Code 10 733147 00201 5, 1/8 lb ","10 733147 00201 5= 11/4/2013 - 11/18/2013 ",".","1,159,754.46 total pounds, for all varieties","Garden-Fresh Foods is recalling various ready-to-eat salads, slaw, and dip products sold under various brands and codes because they may be contaminated with Listeria monocytogenes.",10/30/2013,"10/30/2013",12/11/2013,"12/11/2013"
"Food",66677,"Ongoing","Garden-Fresh Foods, Inc.","Milwaukee","WI","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","CA, IL, IN, MA, MI,MN, MO, OH, PA, WI.","F-0538-2014","Class I","Garden-Fresh Taco Pasta Salad, Product Code 0 11596 52076 6, 1/5 lb "," 0 11596 52076 6 = 11/1/2013 - 11/18/2013 ; ;",".","1,159,754.46 total pounds, for all varieties","Garden-Fresh Foods is recalling various ready-to-eat salads, slaw, and dip products sold under various brands and codes because they may be contaminated with Listeria monocytogenes.",10/30/2013,"10/30/2013",12/11/2013,"12/11/2013"
"Food",66677,"Ongoing","Garden-Fresh Foods, Inc.","Milwaukee","WI","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","CA, IL, IN, MA, MI,MN, MO, OH, PA, WI.","F-0508-2014","Class I","Rogges Sliced Extra Sweet American Potato, Product Code 0 11596 51054 5, 2/5 lb; ","0 11596 51054 5 = 11/9/2013;",".","1,159,754.46 total pounds, for all varieties","Garden-Fresh Foods is recalling various ready-to-eat salads, slaw, and dip products sold under various brands and codes because they may be contaminated with Listeria monocytogenes.",10/30/2013,"10/30/2013",12/11/2013,"12/11/2013"
"Food",66677,"Ongoing","Garden-Fresh Foods, Inc.","Milwaukee","WI","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","CA, IL, IN, MA, MI,MN, MO, OH, PA, WI.","F-0618-2014","Class I","Spoon River Seafood Salad Kit, Product Code 0 11596 55106 , 1/5.5lb ","11596 55106 = 10/31/2013 - 11/14/2013 ",".","1,159,754.46 total pounds, for all varieties","Garden-Fresh Foods is recalling various ready-to-eat salads, slaw, and dip products sold under various brands and codes because they may be contaminated with Listeria monocytogenes.",10/30/2013,"10/30/2013",12/11/2013,"12/11/2013"
"Food",66677,"Ongoing","Garden-Fresh Foods, Inc.","Milwaukee","WI","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","CA, IL, IN, MA, MI,MN, MO, OH, PA, WI.","F-0612-2014","Class I","Finest Traditions Seafood Salad Louie, 10 733147 10974 5 10/30/2013 - 11/18/2013 1/5 lb ","10 733147 10974 5= 10/30/2013 - 11/18/2013 ",".","1,159,754.46 total pounds, for all varieties","Garden-Fresh Foods is recalling various ready-to-eat salads, slaw, and dip products sold under various brands and codes because they may be contaminated with Listeria monocytogenes.",10/30/2013,"10/30/2013",12/11/2013,"12/11/2013"
"Food",66677,"Ongoing","Garden-Fresh Foods, Inc.","Milwaukee","WI","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","CA, IL, IN, MA, MI,MN, MO, OH, PA, WI.","F-0575-2014","Class I","Weis Old Fashion Cole Slaw , 0 41497 05849 5, 6/16 oz Weis Old Fashion Cole Slaw , 0 11596 53100 7, 2/5 lb ","0 41497 05849 5 =10/29/2013 - 11/19/2013 0 11596 53100 7= 10/30/2013 - 11/20/2013 ",".","1,159,754.46 total pounds, for all varieties","Garden-Fresh Foods is recalling various ready-to-eat salads, slaw, and dip products sold under various brands and codes because they may be contaminated with Listeria monocytogenes.",10/30/2013,"10/30/2013",12/11/2013,"12/11/2013"
"Food",66677,"Ongoing","Garden-Fresh Foods, Inc.","Milwaukee","WI","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","CA, IL, IN, MA, MI,MN, MO, OH, PA, WI.","F-0554-2014","Class I","D'Amico & Sons Tortellini Salad, Product Code 0 85239 10128 5, 6/6 oz D'Amico & Sons Tortellini Salad, Product Code 0 85239 12700 1, 6/14 oz ","0 85239 10128 5 =10/30/2013 0 85239 12700 1= 10/30/2013 ; ;",".","1,159,754.46 total pounds, for all varieties","Garden-Fresh Foods is recalling various ready-to-eat salads, slaw, and dip products sold under various brands and codes because they may be contaminated with Listeria monocytogenes.",10/30/2013,"10/30/2013",12/11/2013,"12/11/2013"
"Food",66677,"Ongoing","Garden-Fresh Foods, Inc.","Milwaukee","WI","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","CA, IL, IN, MA, MI,MN, MO, OH, PA, WI.","F-0636-2014","Class I","Garden-Fresh Rocky Road Dessert, Product Code 0 11596 45029 2, 1/4 lb ","0 11596 45029 2 =11/2/2013 - 11/20/2013 ",".","1,159,754.46 total pounds, for all varieties","Garden-Fresh Foods is recalling various ready-to-eat salads, slaw, and dip products sold under various brands and codes because they may be contaminated with Listeria monocytogenes.",10/30/2013,"10/30/2013",12/11/2013,"12/11/2013"
"Food",66677,"Ongoing","Garden-Fresh Foods, Inc.","Milwaukee","WI","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","CA, IL, IN, MA, MI,MN, MO, OH, PA, WI.","F-0659-2014","Class I","Grandpas Garlic Herb Spread, Product Code 0 11596 55907 0, 1/5 lb ","0 11596 55907 0= 10/30/2013 - 11/20/2013 ",".","1,159,754.46 total pounds, for all varieties","Garden-Fresh Foods is recalling various ready-to-eat salads, slaw, and dip products sold under various brands and codes because they may be contaminated with Listeria monocytogenes.",10/30/2013,"10/30/2013",12/11/2013,"12/11/2013"
"Food",66677,"Ongoing","Garden-Fresh Foods, Inc.","Milwaukee","WI","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","CA, IL, IN, MA, MI,MN, MO, OH, PA, WI.","F-0600-2014","Class I","Garden-Fresh Premium Tuna Salad, Product Code 0 11596, 1/5 lb ","0 11596 55101 2 =10/30/2013 - 11/19/2013;",".","1,159,754.46 total pounds, for all varieties","Garden-Fresh Foods is recalling various ready-to-eat salads, slaw, and dip products sold under various brands and codes because they may be contaminated with Listeria monocytogenes.",10/30/2013,"10/30/2013",12/11/2013,"12/11/2013"
"Food",66677,"Ongoing","Garden-Fresh Foods, Inc.","Milwaukee","WI","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","CA, IL, IN, MA, MI,MN, MO, OH, PA, WI.","F-0601-2014","Class I","Garden-Fresh Tuna Twist Salad , Product Code 0 11596 55134 0, 1/5 lb; ","0 11596 55134 0 = 10/31/2013 - 11/14/2013;",".","1,159,754.46 total pounds, for all varieties","Garden-Fresh Foods is recalling various ready-to-eat salads, slaw, and dip products sold under various brands and codes because they may be contaminated with Listeria monocytogenes.",10/30/2013,"10/30/2013",12/11/2013,"12/11/2013"
"Food",66677,"Ongoing","Garden-Fresh Foods, Inc.","Milwaukee","WI","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","CA, IL, IN, MA, MI,MN, MO, OH, PA, WI.","F-0606-2014","Class I","Garden-Fresh Creamy Seafood Salad , 0 11596 55124 1, 2/5 lb ","0 11596 55124 1 = 10/30/2013 - 11/20/2013",".","1,159,754.46 total pounds, for all varieties","Garden-Fresh Foods is recalling various ready-to-eat salads, slaw, and dip products sold under various brands and codes because they may be contaminated with Listeria monocytogenes.",10/30/2013,"10/30/2013",12/11/2013,"12/11/2013"
"Food",66677,"Ongoing","Garden-Fresh Foods, Inc.","Milwaukee","WI","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","CA, IL, IN, MA, MI,MN, MO, OH, PA, WI.","F-0510-2014","Class I","Dairy Fresh Baked Potato Salad, Product Code 0 70163 40659 6, 2/5 lb; "," 0 70163 40659 6 = 11/4/2013 - 11/24/2013;",".","1,159,754.46 total pounds, for all varieties","Garden-Fresh Foods is recalling various ready-to-eat salads, slaw, and dip products sold under various brands and codes because they may be contaminated with Listeria monocytogenes.",10/30/2013,"10/30/2013",12/11/2013,"12/11/2013"
"Food",66677,"Ongoing","Garden-Fresh Foods, Inc.","Milwaukee","WI","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","CA, IL, IN, MA, MI,MN, MO, OH, PA, WI.","F-0665-2014","Class I","Finest Traditions Dill Dip, Product Code 10 733147 10555 9, 6/8 oz; Finest Traditions Dill Dip, Product Code 10 733147 10122 0, 1/8 lb; Spoon River Dill Dip, Product Code 0 11596 55680 2, 1/5 lb; Roundy's Dill Dip, Product Code 0 11150 52603 6, 6/12 oz ","10 733147 10555 9 = 11/6/2013 - 11/25/2013; 10 733147 10122 0= 11/6/2013 - 11/13/2013; 0 11596 55680 2= 11/4/2013 - 12/2/2012; 0 11150 52603 6= 11/5/2013 - 12/13/2013 ",".","1,159,754.46 total pounds, for all varieties","Garden-Fresh Foods is recalling various ready-to-eat salads, slaw, and dip products sold under various brands and codes because they may be contaminated with Listeria monocytogenes.",10/30/2013,"10/30/2013",12/11/2013,"12/11/2013"
"Food",66677,"Ongoing","Garden-Fresh Foods, Inc.","Milwaukee","WI","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","CA, IL, IN, MA, MI,MN, MO, OH, PA, WI.","F-0498-2014","Class I","Weis Potato With Egg Salad, Product Code 0 41497 05841 9 , 12/16 oz; Weis Potato With Egg Salad, Product Code 0 41497 05902 7 , 4/3 lb; Weis Potato With Egg Salad, Product Code 0 11596 51101 6, 2/5 lb. ","0 41497 05841 9 = 10/30/2013 - 11/19/2013; 0 41497 05902 7 = 10/31/2013 - 11/15/2013; 0 11596 51101 6 = 10/31/2013 - 11/20/2013. ",".","1,159,754.46 total pounds, for all varieties","Garden-Fresh Foods is recalling various ready-to-eat salads, slaw, and dip products sold under various brands and codes because they may be contaminated with Listeria monocytogenes.",10/30/2013,"10/30/2013",12/11/2013,"12/11/2013"
"Food",66677,"Ongoing","Garden-Fresh Foods, Inc.","Milwaukee","WI","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","CA, IL, IN, MA, MI,MN, MO, OH, PA, WI.","F-0502-2014","Class I","Finest Traditions Homestyle Potato Salad, Product Code 10 733147 10452 8, 4/8 lb; Finest Traditions Homestyle Potato Salad, Product Code 10 733147 10134 3,1/8 lb; Finest Traditions Homestyle Potato Salad,Product Code 7 33147 00019 9, 6/16 oz; Acme Homestyle Potato Salad, Product Code 0 11596 91029 1, 2/5 lb; Our Own Homestyle Potato Salad,Product Code 0 11596 51042 2, 4/5 lb; Dairy Fresh Homemade Potato Salad, Product Code 0 70163 56575 3, 2/5 lb; ","10 733147 10452 8 = 11/6/2013 - 11/18/2013; 10 733147 10134 3 = 10/30/2013 - 11/18/2013; 7 33147 00019 9 = 11/4/2013 - 11/25/2013; 0 11596 91029 1 =10/31/2013 - 11/2/2013; 0 11596 51042 2 = 10/30/2013 - 11/15/2013; 0 70163 56575 3 = 11/6/2013; ",".","1,159,754.46 total pounds, for all varieties","Garden-Fresh Foods is recalling various ready-to-eat salads, slaw, and dip products sold under various brands and codes because they may be contaminated with Listeria monocytogenes.",10/30/2013,"10/30/2013",12/11/2013,"12/11/2013"
"Food",66677,"Ongoing","Garden-Fresh Foods, Inc.","Milwaukee","WI","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","CA, IL, IN, MA, MI,MN, MO, OH, PA, WI.","F-0574-2014","Class I","Garden-Fresh Cranberry Walnut Red Cabbage Slaw, Product Code 0 11596 83028 5, 1/8.25lb "," 0 11596 83028 5 =10/30/2013 - 11/20/2013 ",".","1,159,754.46 total pounds, for all varieties","Garden-Fresh Foods is recalling various ready-to-eat salads, slaw, and dip products sold under various brands and codes because they may be contaminated with Listeria monocytogenes.",10/30/2013,"10/30/2013",12/11/2013,"12/11/2013"
"Food",66677,"Ongoing","Garden-Fresh Foods, Inc.","Milwaukee","WI","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","CA, IL, IN, MA, MI,MN, MO, OH, PA, WI.","F-0602-2014","Class I","Finest Traditions Tuna Pasta Salad, Product Code 10 733147 10067 4, 1/8 lb ","10 733147 10067 4 = 11/11/2013 - 11/18/2013 ;",".","1,159,754.46 total pounds, for all varieties","Garden-Fresh Foods is recalling various ready-to-eat salads, slaw, and dip products sold under various brands and codes because they may be contaminated with Listeria monocytogenes.",10/30/2013,"10/30/2013",12/11/2013,"12/11/2013"
"Food",66677,"Ongoing","Garden-Fresh Foods, Inc.","Milwaukee","WI","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","CA, IL, IN, MA, MI,MN, MO, OH, PA, WI.","F-0599-2014","Class I","Family Style Creamy Tuna Salad, Product Code 0 11596 55108 1, 2/5 lb; ","0 11596 55108 1 = 10/30/2013 - 11/20/2013;",".","1,159,754.46 total pounds, for all varieties","Garden-Fresh Foods is recalling various ready-to-eat salads, slaw, and dip products sold under various brands and codes because they may be contaminated with Listeria monocytogenes.",10/30/2013,"10/30/2013",12/11/2013,"12/11/2013"
"Food",66677,"Ongoing","Garden-Fresh Foods, Inc.","Milwaukee","WI","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","CA, IL, IN, MA, MI,MN, MO, OH, PA, WI.","F-0497-2014","Class I","Grandpas Steakhouse Potato Salad , Product Code 0 11596 14068 1, 12/16 oz.; Grandpas Steakhouse Potato Salad , Product Code 0 11596, 2/5 lb.; Finest Traditions Steakhouse Potato Salad , Product Code 10 733147 10773 4 11/4/2013 - 11/18/2013 1/8 lb ","0 11596 14068 1 = 10/31/2013 - 11/18/2013 0 11596 55604 8 = 10/29/2013 - 11/20/2013; 10 733147 10773 4 = 11/4/2013 - 11/18/2013;",".","1,159,754.46 total pounds, for all varieties","Garden-Fresh Foods is recalling various ready-to-eat salads, slaw, and dip products sold under various brands and codes because they may be contaminated with Listeria monocytogenes.",10/30/2013,"10/30/2013",12/11/2013,"12/11/2013"
"Food",66677,"Ongoing","Garden-Fresh Foods, Inc.","Milwaukee","WI","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","CA, IL, IN, MA, MI,MN, MO, OH, PA, WI.","F-0616-2014","Class I","Grandpas Krab Dip, 0 11596 55909 4, 1/5 lb ","0 11596 55909 4 = 10/30/2013 - 11/14/2013 ",".","1,159,754.46 total pounds, for all varieties","Garden-Fresh Foods is recalling various ready-to-eat salads, slaw, and dip products sold under various brands and codes because they may be contaminated with Listeria monocytogenes.",10/30/2013,"10/30/2013",12/11/2013,"12/11/2013"
"Food",66677,"Ongoing","Garden-Fresh Foods, Inc.","Milwaukee","WI","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","CA, IL, IN, MA, MI,MN, MO, OH, PA, WI.","F-0514-2014","Class I","Finest Traditions Cheddar & Bacon Potato Filling, Product Code 10 733147 10262 3, 1/8 lb. ","10 733147 10262 3 = 10/30/2013 ; ;",".","1,159,754.46 total pounds, for all varieties","Garden-Fresh Foods is recalling various ready-to-eat salads, slaw, and dip products sold under various brands and codes because they may be contaminated with Listeria monocytogenes.",10/30/2013,"10/30/2013",12/11/2013,"12/11/2013"
"Food",66677,"Ongoing","Garden-Fresh Foods, Inc.","Milwaukee","WI","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","CA, IL, IN, MA, MI,MN, MO, OH, PA, WI.","F-0656-2014","Class I","Grandpas Taco Dip, Product Code 0 11596 55903 2 1/5 lb; Finest Traditions Taco Dip, Product Code 10 733147 10557 0, 6/8 oz; Roundy's Taco Dip, Product Code 0 11150 52604 3,2013 6/12 oz; Maggie's Taco Dip, Product Code 0 11596 06201 3, 6/12 oz ","0 11596 55903 2 = 11/5/2013 - 12/13/2013; 10 733147 10557 0 = 11/4/2013 - 11/18/2013; 0 11150 52604 3= 11/5/2013 - 12/12/2013; 0 11596 06201 3 = 11/5/2013 - 12/16/2013 ",".","1,159,754.46 total pounds, for all varieties","Garden-Fresh Foods is recalling various ready-to-eat salads, slaw, and dip products sold under various brands and codes because they may be contaminated with Listeria monocytogenes.",10/30/2013,"10/30/2013",12/11/2013,"12/11/2013"
"Food",66677,"Ongoing","Garden-Fresh Foods, Inc.","Milwaukee","WI","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","CA, IL, IN, MA, MI,MN, MO, OH, PA, WI.","F-0504-2014","Class I","Finest Traditions Blue Cheese Potato Salad, Product Code 10 733147 10137 4, 1/8 lb; ","10 733147 10137 4 = 11/4/2013;",".","1,159,754.46 total pounds, for all varieties","Garden-Fresh Foods is recalling various ready-to-eat salads, slaw, and dip products sold under various brands and codes because they may be contaminated with Listeria monocytogenes.",10/30/2013,"10/30/2013",12/11/2013,"12/11/2013"
"Food",66677,"Ongoing","Garden-Fresh Foods, Inc.","Milwaukee","WI","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","CA, IL, IN, MA, MI,MN, MO, OH, PA, WI.","F-0620-2014","Class I","Garden-Fresh Club Salad Kit, Product Code 0 11596 53043 7 , 1/3.75lb ","0 11596 53043 7= 10/30/2013 - 10/14/2013 1/3 ",".","1,159,754.46 total pounds, for all varieties","Garden-Fresh Foods is recalling various ready-to-eat salads, slaw, and dip products sold under various brands and codes because they may be contaminated with Listeria monocytogenes.",10/30/2013,"10/30/2013",12/11/2013,"12/11/2013"
"Food",66677,"Ongoing","Garden-Fresh Foods, Inc.","Milwaukee","WI","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","CA, IL, IN, MA, MI,MN, MO, OH, PA, WI.","F-0655-2014","Class I","Grandpas Artichoke Spinach Dip, Product Code 0 11596 55902 5, 1/5 lb; Archer Farms Artichoke Spinach Dip, Product Code 0 85239 99015 5, 6/11 oz; Archer Farms Artichoke Spinach Dip, Product Code 0 85239 69053 6, 4/18 oz; Roundy's Artichoke Spinach Dip, Product Code 0 11596 06170 2, 6/12 oz ","0 11596 55902 5 = 11/15/2013 - 12/13/2013; 0 85239 99015 5 = 11/1/2013; 0 85239 69053 6=11/1/2013; 0 11596 06170 2= 11/8/2013 - 12/15/2013 ",".","1,159,754.46 total pounds, for all varieties","Garden-Fresh Foods is recalling various ready-to-eat salads, slaw, and dip products sold under various brands and codes because they may be contaminated with Listeria monocytogenes.",10/30/2013,"10/30/2013",12/11/2013,"12/11/2013"
"Food",66679,"Ongoing","Diamond Nutriceutical, Inc.","Pomona","CA","US","Voluntary: Firm Initiated","FAX","US states: PA, NJ, TX, CA, NY, FL, NV, OR, WA, OH, MI.","F-0219-2014","Class II","Best in Nature Brand Eye Care Essence, 100 Capsules. Product labeling reads in part:''Best in Nature Eye Care Essence***Dietary Supplement 100 capsules***Manufactured for: Best in Nature Walnut, CA 91789***www.1688best.com***8 92418 001069 6***''. ","Lot Number 8956. Expiration Date 03-2016. UPC Code 8 92418 00109 6.",,"475 bottles","The firm initiated this recall in response to FDA sample findings that major ingredients are omitted partially or entirely. The product did not contain the amounts as labeled for Vitamin A and Vitamin C.",10/30/2013,"10/30/2013",11/27/2013,"11/27/2013"
"Devices",66688,"Ongoing","Trumpf Medical Systems, Inc.","Charleston","SC","US","Voluntary: Firm Initiated","Letter","US Distribution including the states of CA, IL, NJ, NY, NC, TX, WA and SC.","Z-0342-2014","Class II","TruSystem Surgical Table (TS7000) Leg Section One Part Light HU Use of the Leg Section One Part Light HU is permitted only with the TRUMPF TruSystem 7000 operating table. The operating table TruSystem 7000, in conjunction with operating table components is intended for the use of patient positioning during surgery, ranging from anesthesia induction to actual surgery to recovery from anesthesia. The Leg Section One Part Light HU is attached to coupling point L on the operating table and is used to position the patients legs during pre-op and post-op surgery. ","Item no. 1739993, All serial numbers.",,"15 components","The coupler point (hood) of the Leg Section One Part Light may become detached from the leg section frame.",10/28/2013,"10/28/2013",11/27/2013,"11/27/2013"
"Devices",66689,"Ongoing","GlaxoSmithKline, LLC.","Zebulon","NC","US","Voluntary: Firm Initiated","Letter","Nationwide Distribution .","Z-0272-2014","Class II","Biotene Moisturizing Mouth Spray, with xylitol, For dry mouth symptom relief, 44.3ml/1.5 FL. OZ., Sugar Free Sweetened with xylitol and sorbitol, GlaxoSmithKline, Consumer Healthcare, L.P., Moon Township, PA 15108. Biotene Mouth Spray is used for the treatment of dry mouth","UPC: 048582001558, Lot numbers U3E031, U3E151, U3E211, U3F201, U3G031, U3G171, U3G231 and U3G311.",".","483,204 bottles","Label indicates, ''Sweetened with xylitol and Sorbitol'', however product does not contain sorbitol.",10/17/2013,"10/17/2013",11/20/2013,"11/20/2013"
"Food",66693,"Ongoing","Pacific Nutritionals","Vancouver","WA","US","Voluntary: Firm Initiated","E-Mail","Distributed to Florida and Canada.","F-0345-2014","Class II","ParaZYME, 90 capsules per bottle, is dietary supplement and sold under Renew Life brand. The UPC Code 6 31257 30990 7. The product is labeled in parts: ''***PARAZYME***renew LIFE***The Digestive Care Company***90 Vegetable Capsules***Distributed by: ReNew Life Formulas***Palm Harbor, FL 34683***www.renewlife.com***1-800-830-1800***''.","ParaZYME Lot: 57515, 57766, 58607, and 59505.",".","5631 bottles of paraZYEM","Dietary supplement product was made from ingredients that are contaminated with Chloramphenicol.",10/1/2013,"10/01/2013",12/4/2013,"12/04/2013"
"Food",66693,"Ongoing","Pacific Nutritionals","Vancouver","WA","US","Voluntary: Firm Initiated","E-Mail","Distributed to Florida and Canada.","F-0346-2014","Class II","-Superior Digestion, 60 capsules per bottle, is dietary supplement and sold under Purelife Naturals brand. The UPC Code 6 31257 17509 0. -Superior Digestion, Dietary Supplement, Bulk Case, NO UPC. The retail 60 count bottle is labeled in parts: ''***Superior Digestion***purelife NATURALS***60 PURE-CAPS***Distributed by PureLife Naturals***Clearwater, FL 33765***www.purelife-naturals.com***1-800-220-7986***''.","-Superior Digestion 60 counts bottle Lot numbers: 57518, 58183, 58185, and 58969. -Superior Digestion Bulk Lot number: 58066. ",".","1632 bottles (60 counts) and 33,000 capsules (bulk)","Dietary supplement products were made from ingredients that are contaminated with Chloramphenicol.",10/1/2013,"10/01/2013",12/4/2013,"12/04/2013"
"Food",66693,"Ongoing","Pacific Nutritionals","Vancouver","WA","US","Voluntary: Firm Initiated","E-Mail","Distributed to Florida and Canada.","F-0347-2014","Class II","-DigestMORE, 90 capsules per bottle, Food Supplement is sold under Renew Life brand. The UPC Code 6 31257 35000 8. -DigestMORE Ultra, 60 capsules per bottle, Food Supplement is sold under Renew Life brand. The UPC Code 6 31257 35001 5. The DigestMORE product is labeled in parts: ''***DigestMORE***RENEW LIFE***The Digestive Care Company***90 Capsules***Food Supplement***RENEW LIFE UK***Unit 3, 12 Commercial Road, Reading, Berkshire***RG2 0QJ***www.renewlife.co.uk***. The DigestMORE Ultra product is labeled in parts: ''***DigestMORE Ultra***RENEW LIFE***The Digestive Care Company***60 Capsules***Food Supplement***RENEW LIFE UK***Unit 3, 12 Commercial Road, Reading, Berkshire***RG2 0QJ***www.renewlife.co.uk***. ","-DigestMORE (90 capsules) lot number: 59344. -DigestMORE Ultra (60 capsules) lot number: 59343. ",".","1008 bottles of DigestMORE; 1008 bottles of DigestMORE Ultra","Food supplement products were made from ingredients that are contaminated with Chloramphenicol.",10/1/2013,"10/01/2013",12/4/2013,"12/04/2013"
"Food",66697,"Ongoing","World Class Distribution, Inc.","Fontana","CA","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","US States: CA, NV, NM, UT, and TX.","F-0183-2014","Class I","Trader Joe's Southwest Salads, 9oz. Packaged in plastic clamshell with ranch dressing packaged in plastic sealed solo cup. Product labeling reads in part:''TRADER JOE'S ***SOUTHWEST SALAD with Black Beans, Corn, Cotija Cheese and a tangy Ranch Dressing***NET WT. 9 OZ (255g)***DIST. & SOLD EXCLUSIVELY BY: TRADER JOE'S MONROVIA, CA 91016***''.","SKU 56077. Use by Date 11/2/13.",,"1861 units","World Class Distribution of Fontana, California is voluntarily recalling one specific lot of Trader Joe's Southwest Salad (SKU 56077) with Use by Date 11/2/13 due to undeclared soy. ",10/31/2013,"10/31/2013",11/27/2013,"11/27/2013"
"Devices",66698,"Ongoing","SpineFrontier, Inc.","Beverly","MA","US","Voluntary: Firm Initiated",,"US Distribution to VA and TX.","Z-0544-2014","Class II","PedFuse Reset Screw; Model: 01-80115-55 The PedFuse Reset pedicle screw implants intended to be used to help provide immobilization and stabilization of spinal segments as an adjunct to fusion of the thoracic, lumbar, and/or sacral spine.","Lot/Serial Numbers: 357305-000",".","35 Devices","During routine servicing, it was discovered that one 8mmx55mm Reset screw was assembled with an 8mm tulip head and a 9mm screw. The implant should have consisted of an 8mm tulip head and an 8mm screw. A recall was initiated to remove all remaining screws of the same lot from the field to investigate the nonconformity.",10/18/2013,"10/18/2013",12/26/2013,"12/26/2013"
"Food",66704,"Ongoing","Taylor Farms Illinois Inc","Chicago","IL","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","IL","F-0399-2014","Class II","SIG CAFE ITALIAN PASTA SALAD KIT, 216325, NET WT 5.68 LBS, Distributed by Lucerne Foods, Inc., PO Box 99, Pleasanton, CA 94566-0009, 877-232-4271","TFIL286A001, USE BY 10/23/13 ; TFIL288A001, USE BY 10/25/13; TFIL290B001, USE BY 10/27/13; TFIL293A001, USE BY 10/30/13; and TFIL295A001 USE BY 11/1/13; ",".","215 Units","The firm manufactured and distributed one salad kit which contained salad dressing supplied by Reser's which was recalled due to possible Listeria monocytogenes contamination.",10/28/2013,"10/28/2013",12/26/2013,"12/26/2013"
"Devices",66705,"Ongoing","Philips Medical Systems, Inc.","Andover","MA","US","Voluntary: Firm Initiated","Letter","Nationwide Distribution including MN, NH, DE, OR, MA, TX, OH, FL, CA, WA, and SC.","Z-0431-2014","Class II","Easy Diagnost Eleva Universal Fluoroscopic applications","706050, 706083, 706088",".","19 devices","The delivered application software was an outdated version to the model of equipment. ",10/30/2013,"10/30/2013",12/11/2013,"12/11/2013"
"Food",66710,"Ongoing","Taylor Farms Tennessee, Inc.","Smyrna","TN","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","AL, FL, TN, LA, KY, NC, OH, GA, MI, SC, MO","F-0388-2014","Class II","Spinach Antipasti Salad Kit 1cnt, 438405, 1/8#, 59433, TAYLOR FARMS TN, SMYRNA, TN 37167","WO2013283, USE THRU: 10/23/2013; WO2013284, USE THRU: 10/24/2013; WO2013287, USE THRU: 10/27/2013; WO2013289, USE THRU: 10/29/2013; WO2013290, USE THRU: 10/30/2013; WO2013291, USE THRU: 10/31/2013; WO2013294, USE THRU: 11/3/2013; WO2013296, USE THRU: 11/5/2013; WO2013297, USE THRU: 11/6/2013",".","1942 units","The firm manufactured and distributed 6 salad kits which contained salad dressing supplied by Reser's which was recalled due to possible Listeria Monocytogenes contamination.",10/25/2013,"10/25/2013",12/26/2013,"12/26/2013"
"Food",66710,"Ongoing","Taylor Farms Tennessee, Inc.","Smyrna","TN","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","AL, FL, TN, LA, KY, NC, OH, GA, MI, SC, MO","F-0384-2014","Class II","Broccoli Crunch Kit 2 cnt w/ red Onion 10030223091285, 592500, TAYLOR FARMS TN, SMYRNA, TN 37167","WO2013282, USE THRU: 10/23/2013; WO2013283, USE THRU: 10/24/2013; WO2013284, USE THRU: 10/25/2013; WO2013287, USE THRU: 10/28/2013; WO2013289, USE THRU: 10/30/2013; WO2013290, USE THRU: 10/31/2013; WO2013291, USE THRU: 11/1/2013; WO2013294, USE THRU: 11/4/2013 ; WO2013296, USE THRU: 11/6/2013 ; WO2013297, USE THRU: 11/7/2013",".","970 units","The firm manufactured and distributed 6 salad kits which contained salad dressing supplied by Reser's which was recalled due to possible Listeria Monocytogenes contamination.",10/25/2013,"10/25/2013",12/26/2013,"12/26/2013"
"Food",66710,"Ongoing","Taylor Farms Tennessee, Inc.","Smyrna","TN","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","AL, FL, TN, LA, KY, NC, OH, GA, MI, SC, MO","F-0383-2014","Class II","Broccoli Crunch Kit 1 cnt, 432714, 59520, TAYLOR FARMS TN, SMYRNA, TN 37167 ","WO2013283, USE THRU: 10/23/2013; WO2013284, USE THRU: 10/24/2013; WO2013287, USE THRU: 10/27/2013; WO2013289, USE THRU: 10/29/2013; WO2013290, USE THRU: 10/30/2013; WO2013291, USE THRU: 10/31/2013; WO2013294, USE THRU: 11/3/2013; WO2013296, USE THRU: 11/5/2013; WO2013297, USE THRU: 11/6/2013",".","1524 units","The firm manufactured and distributed 6 salad kits which contained salad dressing supplied by Reser's which was recalled due to possible Listeria Monocytogenes contamination.",10/25/2013,"10/25/2013",12/26/2013,"12/26/2013"
"Food",66710,"Ongoing","Taylor Farms Tennessee, Inc.","Smyrna","TN","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","AL, FL, TN, LA, KY, NC, OH, GA, MI, SC, MO","F-0386-2014","Class II","Broccoli Slaw Kit, 1/6.5#, 85004, TAYLOR FARMS TN, SMYRNA, TN 37167","WO2013284, USE THRU: 10/23/2013; WO2013287, USE THRU: 10/26/2013; WO2013288, USE THRU: 10/27/2013; WO2013289, USE THRU: 10/28/2013; WO2013290, USE THRU: 10/29/2013; WO2013291, USE THRU: 10/30/2013; WO2013294, USE THRU: 11/2/2013; WO2013296, USE THRU: 11/4/2013 ; WO2013297, USE THRU: 11/5/2013 ",".","276 units","The firm manufactured and distributed 6 salad kits which contained salad dressing supplied by Reser's which was recalled due to possible Listeria Monocytogenes contamination.",10/25/2013,"10/25/2013",12/26/2013,"12/26/2013"
"Food",66710,"Ongoing","Taylor Farms Tennessee, Inc.","Smyrna","TN","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","AL, FL, TN, LA, KY, NC, OH, GA, MI, SC, MO","F-0385-2014","Class II","Broccoli Crunch Kit PP 92051229, SAFEWAY ITEM#, 1/7#, 59001, DISTRIBUTED BY LUCERNE FOODS, INC, PO BOX 99, PLEASANTON, CA 94566-0009, 1-877-232-4271","WO2013291, USE THRU: 10/28/2013; WO2013296, USE THRU: 11/2/2013",".","2 units","The firm manufactured and distributed 6 salad kits which contained salad dressing supplied by Reser's which was recalled due to possible Listeria Monocytogenes contamination.",10/25/2013,"10/25/2013",12/26/2013,"12/26/2013"
"Food",66710,"Ongoing","Taylor Farms Tennessee, Inc.","Smyrna","TN","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","AL, FL, TN, LA, KY, NC, OH, GA, MI, SC, MO","F-0387-2014","Class II","Giardiniera Vegetable Salad Kit 1cnt, 1/13#, 59431, TAYLOR FARMS TN, SMYRNA, TN 37167","WO2013287, USE THRU: 10/27/2013",".","3 units","The firm manufactured and distributed 6 salad kits which contained salad dressing supplied by Reser's which was recalled due to possible Listeria Monocytogenes contamination.",10/25/2013,"10/25/2013",12/26/2013,"12/26/2013"
"Drugs",66711,"Ongoing","L. Perrigo Co.","Allegan","MI","US","Voluntary: Firm Initiated","Press Release","Nationwide","D-006-2014","Class II","Acetaminophen suspension liquid, 160 mg/5 mL, grape flavor, 2 FL OZ (59 mL) bottle co-packaged with an oral dosing syringe in a carton and sold under the following: a) equate Infants' Pain & Fever acetaminophen suspension liquid, Distributed by: Wal-Mart Stores, Inc., Bentonville, AZ 72716, NDC 49035-946-16, UPC 0 78742 09060 3; b) leader Infants' Pain & Fever acetaminophen suspension, Distributed by Cardinal Health, Dublin, OH 43017, NDC 37205-576-16, UPC 0 96295 12093 6; c) TopCare Infants' Pain & Fever acetaminophen, Distributed by Topco Associates LLC, Elk Grove Village, IL 60007, NDC 36800-946-16, UPC 0 36800 34645 1; d) Walgreens infants' Pain & Fever acetaminophen oral suspension, Distributed By: Walgreen Co., 200 Wilmot Rd., Deerfield, IL 60015, NDC 0363-0946-16, UPC 3 11917 13225 9; e) Kroger Infants' Pain & Fever acetaminophen suspension liquid, Distributed by The Kroger Co., Cincinnati, Ohio 45202, NDC 30142-946-16, UPC 0 41260 35832 6","Lot #: 3JK0653, Exp 07/15; 3JK0433, Exp 07/15; 3KK0817, Exp 08/15; 3JK0673, Exp 08/15; 3KK0494, Exp 08/15; 3KK0360, Exp 08/15",,"108,828 bottles","Defective Delivery System: There is a remote potential that cartons of product could be co-packaged with an oral dosing syringe without dose markings. ",11/1/2013,"11/01/2013",11/27/2013,"11/27/2013"
"Drugs",66711,"Ongoing","L. Perrigo Co.","Allegan","MI","US","Voluntary: Firm Initiated","Press Release","Nationwide","D-004-2014","Class II","Acetaminophen suspension liquid, 160 mg/5 mL, cherry flavor, 2 FL OZ (59 mL) bottle co-packaged with an oral dosing syringe in a carton and sold under the following: a) leader Infants' Pain & Fever acetaminophen suspension, Distributed by Cardinal Health, Dublin, Ohio 43017, NDC 37205-577-16, UPC 0 96295 12095 0; b) Walgreens infants' Pain & Fever acetaminophen oral suspension, Distributed By: Walgreen Co., 200 Wilmot Rd., Deerfield, IL 60015, NDC 0363-0161-16, UPC 3 11917 13221 1; c) Kroger Infants' Pain & Fever acetaminophen suspension liquid, Distributed by The Kroger Co., Cincinnati, Ohio 45202, NDC 30142-161-16, UPC 0 41260 35831 9; d) H-E-B Pain & Fever acetaminophen suspension Infants', Made With Pride & Care For H-E-B, San Antonio, TX 78204, NDC 37808-161-16, UPC 0 41220 88066 9; e) Babies R Us Infants' Pain & Fever acetaminophen suspension, Distributed by Toys R Us, Inc., Wayne, NJ 07470, NDC 51334-161-16, UPC 7 17851 20094 6; f) healthy accents infants' pain & fever acetaminophen suspension liquid, Distributed By: DZA Brands, LLC, Salisbury, NC 28147/Scarborough, ME 04074, NDC 55316-161-16, UPC 7 25439 95814 1; g) Health Mart Pharmacy infants' pain & fever acetaminophen suspension liquid, Distributed by McKesson, One Post Street, San Francisco, CA 94104, NDC 62011-0002-1, UPC 0 52569 13248 7","Lot #: 3HK0671, Exp 06/15; 3JK0610, Exp 07/15; 3KK0606, Exp 08/15",,"35,136 bottles","Defective Delivery System: There is a remote potential that cartons of product could be co-packaged with an oral dosing syringe without dose markings. ",11/1/2013,"11/01/2013",11/27/2013,"11/27/2013"
"Drugs",66711,"Ongoing","L. Perrigo Co.","Allegan","MI","US","Voluntary: Firm Initiated","Press Release","Nationwide","D-005-2014","Class II","Acetaminophen suspension liquid, 160 mg/5 mL, dye-free grape flavor, 2 FL OZ (59 mL) bottle co-packaged with an oral dosing syringe in a carton and sold under the following: a) TopCare Infants' Pain & Fever acetaminophen, Distributed by Topco Associates LLC, Elk Grove Village, IL 60007, NDC 36800-766-16, UPC 0 36800 34650 5; b) Meijer Infants' Pain & Fever acetaminophen oral suspension, Dist. By Meijer Distribution, Inc., 2929 Waler Ave. NW, Grand Rapids, MI 49544, NDC 41250-766-16, UPC 7 13733 31403 9; c) Rite Aid infants' fever reducer & pain reliever oral suspension, Distributed By: Rite Aid, 30 hunter Lane, Camp Hill, PA 17011, UPC 0 11822 35341 0; d) Walgreens infants' Dye-Free Pain & Fever acetaminophen suspension, Distributed By: Walgreen Co., 200 Wilmot Rd., Deerfield, IL 60015, NDC 0363-0766-16, UPC 3 11917 13223 5; e) Kroger Infants' Pain & Fever acetaminophen suspension liquid, Distributed by The Kroger Co., Cincinnati, Ohio 45202, NDC 30142-766-16, UPC 0 41260 35830 2","Lot #: 3GK0704, Exp 04/15; 3JK0597, Exp 08/15; 3KK0359, Exp 08/15",,"27,504 bottles","Defective Delivery System: There is a remote potential that cartons of product could be co-packaged with an oral dosing syringe without dose markings. ",11/1/2013,"11/01/2013",11/27/2013,"11/27/2013"
"Drugs",66711,"Ongoing","L. Perrigo Co.","Allegan","MI","US","Voluntary: Firm Initiated","Press Release","Nationwide","D-003-2014","Class II","Acetaminophen suspension liquid, 160 mg/5 mL, dye-free cherry flavor, co-packaged with an oral dosing syringe in a carton and sold under the following: a) equaling infants' pain & fever acetaminophen suspension liquid, 2 FL OZ (59 mL) bottle, Distributed by SUPERVALU Inc., Eden Prairie, MN 55344, NDC 41163-590-16, UPC 0 41163 48657 7; b) Up & Up dye free infants' pain and fever acetaminophen suspension liquid, 2 FL OZ (59 mL) bottle, Distributed by Target Corporation, Minneapolis, MN 55403, NDC 11673-590-16, UPC 3 70030 62529 1; c) equate Infants' Pain & Fever acetaminophen suspension liquid, 2 FL OZ (59 mL) bottle, Distributed by: Wal-Mart Stores, Inc., Bentonville, AR 72716, NDC 49035-590-16, UPC 6 81131 00185 4; d) Meijer Infants' Pain & Fever acetaminophen oral suspension, 2 FL OZ (59 mL) bottle, Dist. By Meijer Distribution, Inc., 2929 Walker Ave. NW, Grand Rapids, MI 49544, NDC 41250-590-16, UPC 7 13733 31376 6; e) Walgreens infants' Dye-Free Pain & Fever acetaminophen oral suspension, 2 FL OZ (59 mL) bottle, Distributed By: Walgreen Co., 200 Wilmot Rd., Deerfield, IL 60015, NDC 0363-0590-16, UPC 3 11917 13222 8; f) Kroger Infants' Pain & Fever suspension liquid, 4 FL OZ (118 mL) bottle, Distributed by The Kroger Co., Cincinnati, Ohio 45202, NDC 30142-590-26, UPC 0 41260 36738 0; g) Kroger Infants' Pain & Fever acetaminophen suspension liquid, 2 FL OZ (59 mL) bottle, Distributed by The Kroger Co., Cincinnati, Ohio 45202, NDC 30142-590-16, UPC 0 41260 35829 6; h) Publix Infants' painrelief acetaminophen suspension liquid, 2 FL OZ (59 mL), Distributed By Publix Super Markets, Inc., 3300 Publix Corporate Parkway, Lakeland, FL 33811, NDC 55062-590-16, UPC 0 41415 39573 2; i) CareOne Infants' Dye-Free Pain Relief acetaminophen suspension liquid, 2 FL OZ (59 mL) bottle, Distributed By Foodhold U.S.A., LLC, Landover, MD 20785, NDC 41520-590-16, UPC 3 41520 31006 5; j) Harmon FaceValues Infants' Pain & Fever acetaminophen suspension Liquid, 2 FL OZ (59 mL), Distributed by Harmon Stores, Inc., 650 Libert","2 FL OZ Lot #: 3HK0564, Exp 06/15; 3HK0672, Exp 06/15; 3JK0594, Exp 07/15; 3JK0595, Exp 08/15; 3KK0815, Exp 08/15; 4 FL OZ Lot #: 3GK0645, Exp 06/15",,"143,892 bottles","Defective Delivery System: There is a remote potential that cartons of product could be co-packaged with an oral dosing syringe without dose markings. ",11/1/2013,"11/01/2013",11/27/2013,"11/27/2013"
"Devices",66712,"Completed","Stryker Sustainability Solutions","Tempe","AZ","US","Voluntary: Firm Initiated","Letter","US Distribution: in the states of: Arizona, California, and Ohio.","Z-0340-2014","Class II","Reprocessed Diagnostic Electrophysiology (EP) Catheters and Diagnostic EP Catheter Cables, Model Numbers: D6-DR-252-RT, F6-QF-252RT, 201101, 201104, 401442, 401860, D7-A20-131-RT, 401661, 401972, 401977, 401981, 401982, C6-MR/MST4-SA, CB3434CT. Product Usage: Reprocessed diagnostic EP catheters are indicated for temporary intracardiac sensing, recording, stimulation and electrophysiological mapping of cardiac structures. Note: These devices do not support or sustain life. Diagnostic EP Catheter cables are designed as electrode cables with a multi-pin connector on the distal end and the appropriate number of tails on the proximal end. The cables interface an EP catheter with the appropriate external stimulation or recording equipment or serve as an extension cable between an EP catheter and equipment out of immediate reach. Reprocessed diagnostic electrophysiology catheter cables are indicated for use with the appropriate electrode catheter during electrophysiology studies.","Lot/Serial numbers: 1529652 1535548 1538579 1538655 1562418 1562420 1568434 1568478 1596050 1258475 1596051 1535068 1535071 1535072 1559331 1363123 1406041 1531413 1533378 1533385 1535540 1596047 1596048 1471197 1539560 1539561 1541119 1596049 757895 1600879 1520424 1558826 1558827 1600880 1600881 1558103 1434511 1464987 1600882 1313231 1600883 1600884 1401578 1570964 1600670 1600671 ",,"46 units total","Stryker Sustainability Solutions is recalling the Reprocessed Diagnostic Electrophysiology (EP) Catheters Cables due to a potential sterility breach in the package seal.",10/18/2013,"10/18/2013",11/27/2013,"11/27/2013"
"Devices",66714,"Ongoing","Zimmer, Inc.","Warsaw","IN","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution - USA (nationwide) including the states of CA, IN, OH, GA, WI, IA, NE, NJ, PA, NY, MD, NC, AZ, NM, TX, CO, IL, AL, MI, WA, FL and KS, and the countries of China, Japan and Taiwan.","Z-0480-2014","Class II","NexGen Complete Knee Solutions Stemmed Tibial Component Precoat NexGen Tibial Baseplates are part of the NexGen systems of semi-constrained, non-linked condylar knee prosthesis. The device is indicated for patients with severe knee pain and disability due to: Rheumatoid arthritis, osteoarthritis, traumatic arthritis, polyarthritis; Collagen disorders, and/or avascular necrosis of the femoral condyle; Post-traumatic loss of joint configuration, particularly when there is patellofemoral erosion, dysfunction or prior patellectomy; Moderate valgus, varus, or flexion deformities.","00-5980-037-02; lot 6228417",,"128 units","Two complaints were received in which it was reported that the stem would not lock into the tibia. Evaluation of the returned device found that the stemmed portion of the tibial plate would not hold the stem as the connection was too loose. The taper diameter was found to be oversized by .010. ",10/31/2013,"10/31/2013",12/18/2013,"12/18/2013"
"Devices",66717,"Ongoing","Zimmer, Inc.","Warsaw","IN","US","Voluntary: Firm Initiated","E-Mail","Worldwide Distribution - USA (nationwide) and Internationally to Australia, Canada, China, Finland, Germany, and Italy.","Z-0477-2014","Class II","Zimmer Trabecular Metal Total Ankle Tibial Base Component Sizes 1-6 Total ankle arthroplasty is intended to provide a patient with limited mobility by restoring alignment, reducing pain and preserving the flexion/extension movement within the ankle joint.The Zimmer Trabecular Metal Total Ankle is indicated as a total ankle replacement in primary or revision surgery for patients with: '' Rheumatoid arthritis. '' Post-traumatic arthritis. '' Degenerative arthritis. This device is intended for cemented use only.","Part Number Lot Number 00450004100 62143211 00450004100 62215399 00450004100 62226572 00450004100 62239797 00450004100 62248808 00450004100 62285639 00450004100 62290853 00450004200 62143212 00450004200 62208157 00450004200 62208158 00450004200 62215401 00450004200 62220683 00450004200 62226573 00450004200 62248809 00450004200 62267650 00450004200 62285554 00450004200 62299545 00450004200 62393808 00450004200 62416048 00450004200 62419541 00450004300 62143213 00450004300 62160229 00450004300 62208159 00450004300 62215402 00450004300 62220681 00450004300 62220684 00450004300 62267645 00450004300 62279057 00450004300 62285555 00450004300 62285556 00450004300 62305745 00450004300 62305746 00450004300 62310757 00450004300 62349877 00450004300 62357515 00450004300 62368389 00450004300 62378070 00450004300 62397422 00450004300 62409042 00450004300 62416049 00450004300 62419542 00450004300 62442239 00450004300 62453785 00450004400 62168364 00450004400 62208160 00450004400 62215403 00450004400 62220686 00450004400 62232378 00450004400 62267647 00450004400 62297853 00450004400 62299546 00450004400 62299547 00450004400 62299548 00450004400 62343569 00450004400 62349879 00450004400 62372420 00450004400 62393809 00450004400 62397423 00450004400 62405323 00450004400 62409043 00450004500 62143215 00450004500 62215404 00450004500 62220688 00450004500 62232379 00450004500 62248810 00450004500 62254967 00450004500 62279058 00450004500 62299549 00450004500 62368390 00450004500 62378071 00450004600 62143216 00450004600 62239795 00450004600 62239796 00450004600 62248811 00450004600 62254968 00450004600 62285640 00450004600 62290855 00450004600 62405325 00830004100 62208152 00830004100 62316180 00830004100 62363978 00830004200 62204737 00830004200 62226574 00830004200 62239798 00830004200 62316181 00830004200 62337230 00830004200 62375878 00830004300 62204736 00830004300 62226575 00830004300 62232380 00830004300 62297854 00830004300 6232380",,"390 units (US) 129 units (outside of US)","As part of routine manufacturing process monitoring by Zimmer, it was discovered that the Tibial Base and Talar Components from the Total Ankle system have the potential of containing elevated levels of manufacturing materials residue on the implants. The specific material was found to be mass media utilized during the manufacturing process to provide the uniform surface finish. This mass media is comprised of aluminum oxide and a polyester resin binder.",11/12/2013,"11/12/2013",12/18/2013,"12/18/2013"
"Devices",66717,"Ongoing","Zimmer, Inc.","Warsaw","IN","US","Voluntary: Firm Initiated","E-Mail","Worldwide Distribution - USA (nationwide) and Internationally to Australia, Canada, China, Finland, Germany, and Italy.","Z-0476-2014","Class II","Zimmer Trabecular Metal Total Ankle Talar Component Right Sizes 1-6 Total ankle arthroplasty is intended to provide a patient with limited mobility by restoring alignment, reducing pain and preserving the flexion/extension movement within the ankle joint.The Zimmer Trabecular Metal Total Ankle is indicated as a total ankle replacement in primary or revision surgery for patients with: '' Rheumatoid arthritis. '' Post-traumatic arthritis. '' Degenerative arthritis. This device is intended for cemented use only.","Part Number Lot Number 00450002100 62163375 00450002100 62248804 00450002100 62248805 00450002100 62267632 00450002100 62279047 00450002500 62220671 00450002500 62220675 00450002500 62226571 00450002500 62279042 00450002500 62279049 00450002500 62285553 00450002500 62290846 00450002500 62290857 00450002500 62343556 00450002500 62357507 00450002500 62368386 00450002500 62375875 00450002500 62405317 00450002500 62409039 00450002500 62419539 00450002500 62428993 00450002500 62439679 00450002500 62442236 00450002600 11007905 00450002600 62163386 00450002600 62262903 00450002600 62264848 00450002600 62290827 00450002600 62297849 00450002100 62287975 00450002100 62331805 00450002100 62337206 00450002100 62337758 00450002100 62349863 00450002100 62357502 00450002100 62358897 00450002100 62397419 00450002100 62397420 00450002200 62163377 00450002200 62239777 00450002200 62239790 00450002200 62267633 00450002200 62267635 00450002200 62279048 00450002200 62279054 00450002200 62290840 00450002200 62290843 00450002200 62337207 00450002200 62343552 00450002200 62357504 00450002200 62375870 00450002200 62405311 00450002200 62416043 00450002200 62419536 00450002200 62453776 00450002200 62453777 00450002200 62459876 00450002300 11009092 00450002300 62163380 00450002300 62215391 00450002300 62215394 00450002300 62220673 00450002300 62267034 00450002300 62267636 00450002300 62279055 00450002300 62285552 00450002300 62305740 00450002300 62310753 00450002300 62323811 00450002300 62337208 00450002300 62337759 00450002300 62349864 00450002300 62357505 00450002300 62357506 00450002300 62372417 00450002300 62375873 00450002300 62378065 00450002300 62409035 00450002300 62409036 00450002300 62416044 00450002300 62419537 00450002300 62453778 00450002400 62163383 00450002400 62208155 00450002400 62239778 00450002400 62267035 00450002400 62267036 00450002400 62267637 00450002400 62267638 00450002400 62297851 00450002400 62305741 00450002400 6230574",,"265 units (US) 114 units (outside US)","As part of routine manufacturing process monitoring by Zimmer, it was discovered that the Tibial Base and Talar Components from the Total Ankle system have the potential of containing elevated levels of manufacturing materials residue on the implants. The specific material was found to be mass media utilized during the manufacturing process to provide the uniform surface finish. This mass media is comprised of aluminum oxide and a polyester resin binder.",11/12/2013,"11/12/2013",12/18/2013,"12/18/2013"
"Devices",66717,"Ongoing","Zimmer, Inc.","Warsaw","IN","US","Voluntary: Firm Initiated","E-Mail","Worldwide Distribution - USA (nationwide) and Internationally to Australia, Canada, China, Finland, Germany, and Italy.","Z-0475-2014","Class II","Zimmer Trabecular Metal Total Ankle Talar Component Left Sizes 1-6 Total ankle arthroplasty is intended to provide a patient with limited mobility by restoring alignment, reducing pain and preserving the flexion/extension movement within the ankle joint.The Zimmer Trabecular Metal Total Ankle is indicated as a total ankle replacement in primary or revision surgery for patients with: '' Rheumatoid arthritis. '' Post-traumatic arthritis. '' Degenerative arthritis. This device is intended for cemented use only.","Part Number Lot Number 00450001100 62072174 00450001100 62248802 00450001100 62264833 00450001100 62267033 00450001100 62279041 00450001100 62279043 00450001100 62331803 00450001100 62331808 00450001100 62337755 00450001100 62343558 00450001100 62357496 00450001100 62357497 00450001100 62397412 00450001100 62397413 00450001100 62430803 00450001200 11007903 00450001200 11008443 00450001200 62168362 00450001200 62239775 00450001200 62239789 00450001200 62267626 00450001200 62267627 00450001200 62279044 00450001200 62279050 00450001600 62168363 00450001600 62239794 00450001600 62264836 00450001600 62264837 00450001600 62267631 00450001600 62290823 00450001600 62290824 00450001600 62297847 00450001600 62297848 00450001600 62310752 00450001600 62316170 00450001600 62323809 00450001600 62331810 00450001600 62337757 00450001600 62349862 00450001600 62357499 00450001600 62372416 00450001600 62405309 00450001600 62419534 00450001200 62285546 00450001200 62290833 00450001200 62290835 00450001200 62372414 00450001200 62375863 00450001200 62397414 00450001200 62405304 00450001200 62416035 00450001200 62419530 00450001200 62430804 00450001300 62160227 00450001300 62163379 00450001300 62215393 00450001300 62264834 00450001300 62267628 00450001300 62267629 00450001300 62279045 00450001300 62279051 00450001300 62285548 00450001300 62290836 00450001300 62299551 00450001300 62331811 00450001300 62337756 00450001300 62349856 00450001300 62349857 00450001300 62368383 00450001300 62375865 00450001300 62375868 00450001300 62378060 00450001300 62397415 00450001300 62397416 00450001300 62409032 00450001300 62409033 00450001300 62416036 00450001300 62419532 00450001300 62430805 00450001400 11007904 00450001400 11008529 00450001400 62163382 00450001400 62208153 00450001400 62239776 00450001400 62239786 00450001400 62264835 00450001400 62279052 00450001400 62290829 00450001400 62299552 00450001400 62305739 00450001400 62310750 00450001400 6231616",,"269 units (US) 110 units (outside US)","As part of routine manufacturing process monitoring by Zimmer, it was discovered that the Tibial Base and Talar Components from the Total Ankle system have the potential of containing elevated levels of manufacturing materials residue on the implants. The specific material was found to be mass media utilized during the manufacturing process to provide the uniform surface finish. This mass media is comprised of aluminum oxide and a polyester resin binder.",11/12/2013,"11/12/2013",12/18/2013,"12/18/2013"
"Food",66718,"Completed","Ghiringhelli Specialty Foods Inc.","Vallejo","CA","US","Voluntary: Firm Initiated","Press Release","Northern CA and NV (Reno and Carson City)","F-0221-2014","Class I","Trader Giotto's CAESAR Salad with Caesar Dressing; Perishable, keep refrigerated. Packaged in Net Wt. 8.5 oz (241 g) plastic clamshell. Manufactured for Trader Joe's Manufactured by Ghiringhelli Specialty Foods, inc. Vallejo, CA 94950.","Lot 32830110 - USE BY 11/3 - UPC 0005 1613 ",,"709 units","Report of mislabeled Caesar Salads with a use by date of 11/3/13 due to undeclared allergens of soy, fish and wheat on the ingredient and allergen statement.",11/3/2013,"11/03/2013",11/27/2013,"11/27/2013"
"Food",66719,"Ongoing","DUTCH TREAT SALADS, INC","Zeeland","MI","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","74 - 14 oz cups 16 - 5lb bags 75 - 10lb cs (2-5lb bags/cs)","F-0829-2014","Class I","LIPARI OLDTYME Mexicali Dip, Keep Refrigerated, outer box Net Wt. 1 0 lbs. Distributed by Lipari Foods, Warren, Ml 48089 Inner container: Mexicali Dip, Dutch Treat Salads, Zeeland MI Net Wt. 5 Lbs. Mexicali Dip, Dutch Treat Salads, Zeeland , MI Net Wt 14 oz. 396.9 g Ingredients: INGREDIENTS CULTURED SOUR CREAM (PASTURIZED HOMOGENIZED MILK, CREAM, MODIFIED FOOD STARCH, NONFAT DRIED MILK, SODIUM PHOSPHATE, GUAR GUM, SODIUM NITRATE, POTASSIUM SORBATE, CARRAGEENAN, lOCUST BEAN GUM, ACTIVE CULTURE), BLACK( BEAN SALSA (TOMATOES, BLACK BEANS, WATER, CORN, TOMATO PASTE, RED Bell PEPPER, JALAPENO PEPPER, VINEGAR, SEASONING, Salt, SUG AR, SPICES, DEHYDRATED GARLIC, CILANTRO CONCENT, XA NTHAN GUM, POTASSIUM SORBATE, SODIUM BENZOATE, DRIED CHIVES), CHEDDAR CHEESE, MAYONNAISE (VGETABLE OIL [SOYBEAN AND CANOlLA OILS], EGG YOLK, WATER CORN SYRUP, VINIEGAR. SALT. SPICES. CALCIUM DISODIUM E'DTA) S'EASONING MIX. CHILl POWDER. POTASSIUM SOHBATE CONTAINS: EGG. MILK, SOY ","Use By dates of 10/18/13 through 11/22/13.",".","894.75 LBS","Product has potential Listeria monocytogenes contamination. ",10/30/2013,"10/30/2013",12/26/2013,"12/26/2013"
"Devices",66720,"Ongoing","SALTER LABS","Arvin","CA","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Distributed in the states of MS, TX FL,, WI, MI, VA, NY, MO, NC, and MS.","Z-0360-2014","Class II","Salter Labs EtCO2 Sample line 15' (4.6 M) tube, male luer connectors. Rx only; Made in Mexico; Manufacturer:Salter Labs, 100 West Sycamore Road, Arvin, CA 93203. CO2 sample line. ","Model number: 4515-15-25; lot numbers 071513, 071513A and 120312.",,"91 cases (25 units per case)","It has been determined that three lots of model number 4515-15-25 CO2 Sample Line 15' tube, male Luer lock connectors may contain a 30' tube instead of the 15' length.",11/1/2013,"11/01/2013",11/27/2013,"11/27/2013"
"Devices",66721,"Ongoing","Del Mar Reynolds Medical, Ltd.","Hertford",,"GB","Voluntary: Firm Initiated","Telephone","Worldwide Distribution - USA (nationwide) including Oklahoma and North Carolina and Internationally to Libyan Arab Jamahiriya, Finland, Jordan, Mexico, Papua New Guinea, and Taiwan.","Z-0352-2014","Class I","CAS I/II Absorbers that are parts of the BleaseSirius Anesthesia Workstation, the BleaseFocus Anesthesia Workstation with the following part numbers: 12200900; 12200901; 12200902; 12200903; 14200100, and service kits part number 050-0659-00 and 050-0901-00. BleaseFocus Anesthesia Workstation: The Blease Frontline Plus Range, Anesthesia Machines are intended for use in the hospital environment and locations not requiring portability. It may be used for the delivery of oxygen, air and nitrous oxide in a controlled manner to various patient breathing circuits with or without the use of a mechanical ventilator, and may be used for the delivery of anesthetic vapor by use of a dismountable vaporizer. This device is intended for use only by a suitably qualified physician. BleaseSirius Anesthesia Workstation: The Spacelabs BleaseSirius Anesthesia Workstation is intended for use in the hospital environment and operating room. It may be used for the delivery of oxygen, air and nitrous oxide in a controlled manner to various patient breathing circuits with or without the use of mechanical ventilator, and may be used for the delivery of anesthetic vapor by use of a dismountable vaporizer. The device is intended for use only by a suitably qualified physician. ","SERIAL NUMBERS IN THE US: ABSO-001754, ABSO-004081, ABSO-100111, ABSO-100112, ABSO-100113, ABSO-100114, ABSO-100117, ABSO-100120, ABSO-100121, ABSO-100122, ABSO-100123, ABSO-100124, ABSO-100125, ABSO-100126, ABSO-100127, ABSO-100128, ABSO-100132, ABSO-100134, and ABSO-100135. SERIAL NUMBERS INTERNATIONAL: ABSO-100098, ABSO-100099, abso-100100, ABSO-100101, abso-100102, ABSO-100103, abso-100104, abso-100105, abso-100106, ABSO-100107, ABSO-100108, ABSO-100109, ABSO-100110, ABSO-100129, ABSO-100130, ABSO-100131, ABSO-100136, AND ABSO-100137. ",,"37 units (19 in the US and 18 International)","Spacelabs Healthcare Ltd. of United Kingdom recalls , and Service Kits, Part Number 050-0659-00 and 050-0901-00. The Bag to-Vent switch in CAS I/II Absorbers may fail due to loose fastening hardware in an absorber.",10/17/2013,"10/17/2013",11/27/2013,"11/27/2013"
"Food",66722,"Ongoing","Las Trojes","Anaheim","CA","US","Voluntary: Firm Initiated","Letter","CA","F-0393-2014","Class II","Peanut Brittle (''Pepitoria De Cacahuate''), in cellophane packages, Net Wt. 2 oz (57g), UPC 6 61444 00012 6. ","Las Trojes Lot Codes: 03092014, 03162014. El SuperLeon Ponchin Lot Codes: 03162014. Happy Snacks (Seyma Products) lot codes: 03092014. ",".","4,100 units ","Las Trojes is recalling Las Trojes brittle snack foods because they may contain undeclared soy lecithin.",11/1/2013,"11/01/2013",12/4/2013,"12/04/2013"
"Food",66722,"Ongoing","Las Trojes","Anaheim","CA","US","Voluntary: Firm Initiated","Letter","CA","F-0392-2014","Class II","Pumpkin Seed Brittle (''Pepitoria''), in cellophane packages, Net Wt. 2 oz (57g), UPC 6 61444 0000 5 8. ","Las Trojes Lot Codes: 03092014, 03162014. El SuperLeon Ponchin Lot Codes: 03162014. Happy Snacks (Seyma Products) lot codes: 03092014. ",".","1,700 units ","Las Trojes is recalling Las Trojes brittle snack foods because they may contain undeclared soy lecithin.",11/1/2013,"11/01/2013",12/4/2013,"12/04/2013"
"Food",66722,"Ongoing","Las Trojes","Anaheim","CA","US","Voluntary: Firm Initiated","Letter","CA","F-0390-2014","Class II","Sesame Seed Brittle (''Pepitoria De Ajonjoli''), in cellophane packages, Net Wt. 2 oz (57g), UPC 6 61444 00006 5. ","Las Trojes Lot Codes: 03092014, 03162014. El SuperLeon Ponchin Lot Codes: 03162014. Happy Snacks (Seyma Products) lot codes: 03092014. ",".","3,175 units ","Las Trojes is recalling Las Trojes brittle snack foods because they may contain undeclared soy lecithin.",11/1/2013,"11/01/2013",12/4/2013,"12/04/2013"
"Food",66722,"Ongoing","Las Trojes","Anaheim","CA","US","Voluntary: Firm Initiated","Letter","CA","F-0391-2014","Class II","Coconut Brittle (''Pepitoria De Coco''), in cellophane packages, Net Wt. 2 oz (57g), UPC 6 61444 00013 3. ","Las Trojes Lot Codes: 03092014, 03162014. El SuperLeon Ponchin Lot Codes: 03162014. Happy Snacks (Seyma Products) lot codes: 03092014. ",".","1,100 units ","Las Trojes is recalling Las Trojes brittle snack foods because they may contain undeclared soy lecithin.",11/1/2013,"11/01/2013",12/4/2013,"12/04/2013"
"Food",66722,"Ongoing","Las Trojes","Anaheim","CA","US","Voluntary: Firm Initiated","Letter","CA","F-0389-2014","Class II","Mixed Seed Brittle (''Pepitoria Mixed''), in cellophane packages, Net Wt. 2oz (57g), UPC 6 61444 00017 1.","Las Trojes lot codes: 03092014, 03162014. El SuperLeon Ponchin Snack lot code: 03162014. Happy Snacks Lot codes: 03092014. ",".","6,750 units","Las Trojes is recalling Las Trojes brittle snack foods because they may contain undeclared soy lecithin.",11/1/2013,"11/01/2013",12/4/2013,"12/04/2013"
"Devices",66723,"Ongoing","Synthes USA HQ, Inc.","West Chester","PA","US","Voluntary: Firm Initiated","Telephone","US Distribution in Colorado","Z-0401-2014","Class II","Synthes 4.5MM TI VA-LCP CRVD Condylar Plate/6H/159MM/RT-STER Synthes 4.5MM TI VA-LCP CRVD Condylar Plate/6H/159MM/RT-STER is used for buttressing multi fragmentary diatal femur fractures including: supra-condylar, intra-articular and extra articular condylar fractures, periprosthetic fractures, fractures in normal or osteopenic bone, nonunions and malunions.","part 04.124.406S, lot 3771678. ",".","1","A plate was inadvertently released to a sales consultant that was restricted for sale. ",5/29/2013,"05/29/2013",12/4/2013,"12/04/2013"
"Devices",66724,"Ongoing","Siemens Medical Solutions USA, Inc","Martinez","CA","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution: USA (nationwide) including states of: FL, NC, NY, PA, TN, UT, and WI; and countries of: Angola, Brazil, Canada, P.R. China, Germany, India, Japan, Republic Korea, Poland, and Thailand.","Z-0437-2014","Class II","SIEMENS brand ONCOR series Linear Accelerator Linac systems with component: any photon unflat beam option(Multiple X feature) in combination with the IMRT or mARC option. A family of linear accelerator systems is to deliver X-ray photon and electron radiation for the therapeutic treatment of cancer. The ARTISTE/ONCOR systems are manufactured by: SIEMENS AG, MEDICAL SOLUTIONS, Roentgenstrasse 19-21, Kemnath, GERMANY 95478 and distributed SIEMENS Healthcare IM CR RO, CR Radiation Oncology, Martinez, CA. ","Serial Numbers: 5281, 5385, 5445",".","3 units","SIEMENS became aware of two (2) customer complaints concerning a safety risk regarding a potentially existing dark current radiation phenomenon on the Linear Accelerator (LINAC) in combination with IMRT or mARC (rotational IMRT) treatments using unflat (flattening filter free) beams. In case there are many long periods of field shape changes in a treatment plan, the dose due to dark current radiation may sum up to a significant value.",10/23/2013,"10/23/2013",12/11/2013,"12/11/2013"
"Devices",66724,"Ongoing","Siemens Medical Solutions USA, Inc","Martinez","CA","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution: USA (nationwide) including states of: FL, NC, NY, PA, TN, UT, and WI; and countries of: Angola, Brazil, Canada, P.R. China, Germany, India, Japan, Republic Korea, Poland, and Thailand.","Z-0438-2014","Class II","SIEMENS brand ARTISTE Linear Accelerator Linac systems with component: any photon unflat beam option (Multiple X feature) in combination with the IMRT or mARC option. A family of linear accelerator systems is to deliver X-ray photon and electron radiation for the therapeutic treatment of cancer. The ARTISTE/ONCOR systems are manufactured by: SIEMENS AG, MEDICAL SOLUTIONS, Roentgenstrasse 19-21, Kemnath, GERMANY 95478 and distributed SIEMENS Healthcare IM CR RO, CR Radiation Oncology, Martinez, CA ","Serial Numbers: 5364, 5419, 5640, 5737, 5823, 5830, 5166, 5342, 5416, 5444, 5479, 5485, 5628, 5745, 5746, 5762, 5763, 5764, 5772, 5781, 5783, 5797, 5815, 5819, 5820, 5822, 5829, 5837, 5839, 5888, 5896, 5911, 5937 ",".","26 units","SIEMENS became aware of two (2) customer complaints concerning a safety risk regarding a potentially existing dark current radiation phenomenon on the Linear Accelerator (LINAC) in combination with IMRT or mARC (rotational IMRT) treatments using unflat (flattening filter free) beams. In case there are many long periods of field shape changes in a treatment plan, the dose due to dark current radiation may sum up to a significant value.",10/23/2013,"10/23/2013",12/11/2013,"12/11/2013"
"Devices",66725,"Ongoing","Toshiba American Medical Systems Inc","Tustin","CA","US","Voluntary: Firm Initiated","Letter","USA Nationwide Distribution in the states of: CA, FL, GA, IA, NV, NY, LA, IN, PA, OR, TX, and WI.","Z-0201-2014","Class II","Titan 3T MRI System, MRT-3010A/5. Product Usage: Usage: MRI system. ","Lot numbers not utilized. Serial Numbers:A5B1192003 A5B1192004, A5B11Y2005, A5B11Z2007, A5C1212008, A5C1212009, A5C1222010, A5C1232011, A5C1252012, A5C1262013, A5C1282014, A5C1292015, A5C12X2016, A5C12Y2017, A5C12Z2018, A5D1312019, A5D1322020, A5D1362021, XIB-A5A1082001, XIB-A5B11Y2006, A5D1372022, A5B1182002.",".","18 units","Toshiba America Medical Systems, Inc. is recalling due to a potential problem with Specific Absorption Rate (SAR) values when using the Toshiba Titan 3T System. When the system is used in combination with either the QD Head Coil (MJQH-142A) or the Large Knee SPEEDER (MJAJ-182A), SAR values lower than the actual SAR values may be displayed on the operating monitor.",10/28/2013,"10/28/2013",11/20/2013,"11/20/2013"
"Devices",66726,"Ongoing","Spacelabs Healthcare, Llc","Snoqualmie","WA","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution-Distributed in Puerto Rico and the countries of France, Indonesia, Korea, Nicaragua, Philippines, and Taiwan.","Z-0188-2014","Class II","Spacelabs Healthcare elance Vital Signs Monitor, Model 93300, with Option S. It is a patient monitor with arrhythmia detection or alarms.","SERIAL NUMBER IN THE US: 3300-203410 SERIAL NUMBERS INTERNATIONAL: 3300-203361, 3300-203362, 3300-203363, 3300-203364, 3300-203386, 3300-203387, 3300-203388, 3300-203389, 3300-203390, 3300-203391, 3300-203392, 3300-203393, 3300-203394, 3300-203395, 3300-203396, 3300-203397, 3300-203398, 3300-203399, 3300-203400, 3300-203401, 3300-203402, 3300-203403, 3300-203404, 3300-203405, 3300-203406, 3300-203407, 3300-203408, 3300-203409, 3300-203410, 3300-203443, 3300-203444, 3300-203445, 3300-203446, 3300-203447, 3300-203448, 3300-203449, 3300-203450, 3300-203451, 3300-203452, 3300-203453, 3300-203454, 3300-203455, 3300-203456, 3300-203457, 3300-203458, 3300-203459, 3300-203460, 3300-203461, 3300-203462, 3300-203463, 3300-203464, 3300-203465, 3300-203466, 3300-203467, 3300-203468, 3300-203469, 3300-203470, 3300-203471, 3300-203472, 3300-203473, 3300-203474, 3300-203475, 3300-203476, 3300-203477, 3300-203478, 3300-203479, 3300-203480, 3300-203481, 3300-203482, 3300-203483, 3300-203484, 3300-203485, 3300-203486, 3300-203487, 3300-203488, 3300-203489, 3300-203490, 3300-203491, 3300-203492, 3300-203501, 3300-203502, 3300-203503, 3300-203504, 3300-203505, 3300-203506, 3300-203507, 3300-203508, 3300-203509, and 3300-203511.",".","89 units total (1 in US and 88 International)","Spacelabs Healthcare elance Vital Signs Monitor with Option S, model 93330, is recalled because the monitor will not permit connection of any of the Spacelabs TruLink line of SpO2 sensors.",10/17/2013,"10/17/2013",11/20/2013,"11/20/2013"
"Devices",66727,"Ongoing","Spacelabs Healthcare, Llc","Snoqualmie","WA","US","Voluntary: Firm Initiated","Letter","Worldwide distribution: US (nationwide) including states of: Georgia, Idaho, New York, Oklahoma, Tennessee, Texas, and Wyoming and in countries of: Bahrain, Canada, France, Great Britain, Poland, and The Netherlands.","Z-0351-2014","Class II","Spacelabs Healthcare qube Compact Patient Monitor, Model 91390. It is a patient monitor with arrhythmia detection or alarms. The qube is intended for use under the direct supervision of a licensed healthcare practitioner, or by personnel trained in proper use of the equipment in a hospital environment. These devices determine a) when an alarm condition is violated; b) the alarm priority (i.e. high, medium or low); c) alarm limits; and d) when to initiate and terminate alarm notifications. ","SERIAL NUMBERS IN THE US: 1390-101940, 1390-101945, 1390-101946, 1390-101947, 1390-101948, 1390-101950, 1390-101951, 1390-101952, 1390-101953, 1390-101954, 1390-101955, 1390-101956, 1390-101957, 1390-101958, 1390-101962, 1390-101963, 1390-101971, 1390-101972, 1390-101973, 1390-101974, 1390-101979, 1390-101980, 1390-101994, 1390-102002, 1390-102003, 1390-102004, 1390-102005, 1390-102006, 1390-102007, 1390-102008, 1390-102009, 1390-102010, 1390-102011, 1390-102012, 1390-102013, 1390-102014, 1390-102015, 1390-102016, 1390-102017, 1390-102018, 1390-102019, and 1390-102020. SERIAL NUMBER INTERNATIONAL: 1390-101949, 1390-101969, 1390-101970, 1390-101975, 1390-101976, 1390-101977, 1390-101978, 1390-102001, 1390-102021, 1390-102022, 1390-102023, and 1390-102024. ",,"54 units total (42 units in the US and 12 outside US)","Spacelabs Healthcare qube Compact Patient Monitor, Model 91390, may fail to power ON due to incorrect programmed microcontroller component.",10/17/2013,"10/17/2013",11/27/2013,"11/27/2013"
"Biologics",66730,"Terminated","American National Red Cross (The)","Oakland","CA","US","Voluntary: Firm Initiated","FAX","California","B-0123-14","Class II","Red Blood Cells Leukocytes Reduced","W20841304118800; ",,"1 unit","Misbranded red blood cell was distributed. ",9/11/2013,"09/11/2013",12/18/2013,"12/18/2013"
"Food",66734,"Ongoing","Simply D'Lish, LLC","Aurora","IL","US","Voluntary: Firm Initiated","Telephone","US: IL, WI","F-0697-2014","Class II","Key Lime Sugar Cookie, 3-oz (85g), individually wrapped in plastic and labeled in part: Manufactured for Simply D'lish, LLC.; Aurora, IL 60504; www.simplydlish.biz","Lot Code: 13217, 13220, 13235",".","21 cases (2,520 cookies)","On the back label of the individual cookie, the milk allergen was not declared in the allergen statement, however, butter was listed as an ingredient.",10/29/2013,"10/29/2013",12/11/2013,"12/11/2013"
"Food",66734,"Ongoing","Simply D'Lish, LLC","Aurora","IL","US","Voluntary: Firm Initiated","Telephone","US: IL, WI","F-0700-2014","Class II","Sea Salt Chocolate Chip Cookie, 3-oz (85g), individually wrapped in plastic and labeled in part: Manufactured for Simply D'lish, LLC.; Aurora, IL 60504; www.simplydlish.biz","Lot Code: 13220 ",".","23 cases (2,640 cookies)","On the back label of the individual cookie, the milk allergen was not declared in the allergen statement, however, butter was listed as an ingredient.",10/29/2013,"10/29/2013",12/11/2013,"12/11/2013"
"Food",66734,"Ongoing","Simply D'Lish, LLC","Aurora","IL","US","Voluntary: Firm Initiated","Telephone","US: IL, WI","F-0696-2014","Class II","Caramel Sea Salt Chocolate Chip Cookie, 3-oz (85g), individually wrapped in plastic wrapper and labeled in part: Manufactured for Simply D'lish, LLC.; Aurora, IL 60504; www.simplydlish.biz","Lot Code: 13220, 13221, 13235",".","15 cases (2,160 cookies)","On the back label of the individual cookie, the milk allergen was not declared in the Contains, allergen statement.",10/29/2013,"10/29/2013",12/11/2013,"12/11/2013"
"Food",66734,"Ongoing","Simply D'Lish, LLC","Aurora","IL","US","Voluntary: Firm Initiated","Telephone","US: IL, WI","F-0698-2014","Class II","Vermont Maple Oat Cookie, 3-oz (85g), individually wrapped in plastic and labeled in part: Manufactured for Simply D'lish, LLC.; Aurora, IL 60504; www.simplydlish.biz","Lot Code: 13217, 13220, 13235, 13277",".","14 cases (1,680 cookies)","On the back label of the individual cookie, the milk allergen was not declared in the allergen statement, however, butter was listed as an ingredient.",10/29/2013,"10/29/2013",12/11/2013,"12/11/2013"
"Food",66734,"Ongoing","Simply D'Lish, LLC","Aurora","IL","US","Voluntary: Firm Initiated","Telephone","US: IL, WI","F-0699-2014","Class II","Peanut Butter Chocolate Chip Cookie,3-oz (85g), individually wrapped in plastic and labeled in part: Manufactured for Simply D'lish, LLC.; Aurora, IL 60504; www.simplydlish.biz","Lot Code: 13220 ",".","10 cases (1,440 cookies)","On the back label of the individual cookie, the milk allergen was not declared in the allergen statement, however, butter was listed as an ingredient.",10/29/2013,"10/29/2013",12/11/2013,"12/11/2013"
"Devices",66735,"Ongoing","Nephros Inc","River Edge","NJ","US","Voluntary: Firm Initiated","Letter","USA Nationwide Distribution","Z-0490-2014","Class I","Nephros Dual Stage Ultra Filter (DSU) Brochure Document 60-3003 Revisions: 0, 1, 2 Product Usage: A disposable point of use water ultrafilter that delivers microbiologically pure water for washing and drinking.","Item #10-0230; 70-0231; 70-0232; 70-0234; and 70-0235 Document numbers 60-0237 (all) and 60-3003 (all)",".","3,367 untis with affected labeling","Promotional materials for non-medical water filtration products were determined to promote claims which constitute marketing the product as a medical device.",10/28/2013,"10/28/2013",12/26/2013,"12/26/2013"
"Devices",66736,"Ongoing","Nephros Inc","River Edge","NJ","US","Voluntary: Firm Initiated","Letter","Nationwide Distribution","Z-0487-2014","Class I","Nephros SafeSpout Manufacturer: Nephros Inc. 41 Grand Avenue, River Edge, NJ 07661 Assembled at : MEDICA 41036 Medolla, Italy Filters are packaged in a Tyvek pouch and then placed inside a cardboard box. 15 filters per box The Nephros SafeSpout and SafeShower are intended to filter water for washing and drinking. They are intended to be installed at the end of a standard sink faucet or shower hose","Item Number 70-023 and 70-0238 all lots Document number 60-0237, 60-3004 and 60-3005 - all documents",".","3742 units","Promotional materials for non-medical water filtration products were determined to promote claims which constitute marketing the product as a medical device.",10/28/2013,"10/28/2013",12/26/2013,"12/26/2013"
"Devices",66736,"Ongoing","Nephros Inc","River Edge","NJ","US","Voluntary: Firm Initiated","Letter","Nationwide Distribution","Z-0488-2014","Class I","1) Nephros SafeShower FH - 15 filters per box; item no. 70-0236 2) Nephros SafeShower HH -6 filters per box ; item no. 10-0237 Manufactured by : Nephros, Inc. 41 Grand Ave, River Edge, NJ 07661 Assembled at MEDICA 41036 Medolla, Italy The Nephros SafeSpout and SafeShower are intended to filter water for washing and drinking. They are intended to be installed at the end of a standard sink faucet or shower hose","Item Number 70-0236 and 70-0237 all lots Document number 60-0237, 60-3004 and 60-3005 - all documents",".","3472 SS units; 513 FH units; 1219 HH units","Promotional materials for non-medical water filtration products were determined to promote claims which constitute marketing the product as a medical device.",10/28/2013,"10/28/2013",12/26/2013,"12/26/2013"
"Food",66738,"Ongoing","Bairn Biologics","Las Vegas","NV","US","Voluntary: Firm Initiated","Letter","US and Australia, Guatemala, United Kingdom, Israel, Canada and Japan.","F-0163-2014","Class II","Bairn Biologics Candisol; Natural Enzymes to Support a Health Gastrointestinal Tract. Dietary Supplement; Ingredients: Vegetarian Cellulase, Vegetarian Hemicellulase, Vegetarian Xylanase, Vegetarian Beta-glucanase, microcrystalline Cellulose, L-Leucine, Vegetable Capsule. Packaged in 40 and 120 count amber glass bottles. Bairn Biologics, P.O. Box 95966 Las Vegas, NV 89183","all lots manufactured from 2009 forward; Expiry dates: March 2011 through May 2015.",".","8232 bottles of 40 count; 27, 882 bottles of 120 count.","Firm was notified by supplier of xylanase enzymes that they were contaminated with Chloramphenicol.",10/24/2013,"10/24/2013",11/20/2013,"11/20/2013"
"Devices",66739,"Ongoing","Thermofisher Scientive","Fremont","CA","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution - USA (nationwide) including Puerto Rico and internationally to Hong Kong.","Z-0383-2014","Class III","MAS Urinalysis Control Level 1, Multi-analyte control (Assayed and Unassayed), Catalog/Part Numbers: 024222; Product is manufactured and distributed by Microgenics Corporation, a subsidiary of Thermo Fisher Scientific, Clinical Diagnostic Division, Fremont, CA MAS Urinalysis is intended for use in the clinical laboratory as a control for qualitative and semi-quantitative procedures used in routine urinalysis testing. Assay values are provided for specific systems listed. The user can compare observations with expected ranges as a means of assuring consistent performance of reagent and equipment. The product is suitable for use as a control material for physiochemical, chemical, and microscopic methods of routine urinalysis. Urinalysis may be used in conjunction with commercially available standardized systems for urine microscopic analysis.","Lot Number: UA1514011",".","914 units","Via one (1) consumer complaint and in-house testing has confirmed that the product does not meet the 30 day open vial stability specifications for Lot: UA1514011.",10/29/2013,"10/29/2013",12/4/2013,"12/04/2013"
"Food",66740,"Ongoing","Cho & So, Inc. DBA Oh Bok Bakery","Philadelphia","PA","US","Voluntary: Firm Initiated","Letter","MD for further distribution by own label distributor","F-0170-2014","Class II","Sweet Bread known as Bam Bbang (Chestnut Bread) packed on styrofoam tray with plastic over wrap ASSI brand Korean Cake 20646D Net Wt.: 8 oz. Distributed by Rhee Bros., Inc. 7461 Coca Cola Dr Hanover, MD 21076 Expiration date 1/29/14 With Korean language labeling ","product code: 20646D Expiration date: 1/21/14",".","20 cases/20 units per case","''Wheat'' flour was not declared on the label",11/5/2013,"11/05/2013",11/20/2013,"11/20/2013"
"Food",66740,"Ongoing","Cho & So, Inc. DBA Oh Bok Bakery","Philadelphia","PA","US","Voluntary: Firm Initiated","Letter","MD for further distribution by own label distributor","F-0168-2014","Class II","Walnut shaped soft Cookie packed on styrofoam tray with plastic over wrap ASSI brand Korean Cake 20644D Net Wt.: 8 oz. Distributed by Rhee Bros., Inc. 7461 Coca Cola Dr Hanover, MD 21076 Expiration date 3/20/14 With Korean language labeling ","product code: 20644D Expiration date: 3/20/14",".","14 cases/24 units per case","''Wheat'' flour was not declared on the label",11/5/2013,"11/05/2013",11/20/2013,"11/20/2013"
"Food",66740,"Ongoing","Cho & So, Inc. DBA Oh Bok Bakery","Philadelphia","PA","US","Voluntary: Firm Initiated","Letter","MD for further distribution by own label distributor","F-0169-2014","Class II","Doughnuts packed on styrofoam tray with plastic over wrap ASSI brand Korean Cake 20645D Net Wt.: 8 oz. Distributed by Rhee Bros., Inc. 7461 Coca Cola Dr Hanover, MD 21076 Expiration date 1/29/14 With Korean language labeling ","product code: 20645D Expiration date: 1/29/14",".","10 cases/20 units per case","''Wheat'' flour was not declared on the label",11/5/2013,"11/05/2013",11/20/2013,"11/20/2013"
"Food",66743,"Ongoing","21st Century Healthcare, Inc.","Tempe","AZ","US","Voluntary: Firm Initiated","Letter","US States: FL, OH, MN, WA, CA, UT, SC, TN, IA.","F-0165-2014","Class II","Digestive Enzymes, 60 Capsules/Bottle under the following brand names: 21st Century Digestive Enzymes, 60 Capsules/Bottle. HyVee Digestive Eymes, 60 Capsules/Bottle.","UPC Codes: 21st Century: 7-40985-22556-1, HyVee: 0-75450-31144-0. Lot Codes: 21st Century : 7465500, 7465501, 7658200. HyVee : 7757400. Expriation: 03/2016. ",".","6483 bottles","This voluntary recall is initiated because raw material used may contain trace amounts of the antibiotic chloramphenicol.",11/1/2013,"11/01/2013",11/20/2013,"11/20/2013"
"Biologics",66750,"Terminated","American National Red Cross The","Pomona","CA","US","Voluntary: Firm Initiated","Telephone","CA","B-0221-14","Class III","Whole Blood CPDA-1","W20061307689700",".","1 unit","Blood product, which may have been exposed to unacceptable temperature during storage, was distributed.",9/11/2013,"09/11/2013",12/26/2013,"12/26/2013"
"Biologics",66751,"Terminated","LifeSouth Community Blood Centers, Inc.","Dunwoody","GA","US","Voluntary: Firm Initiated","FAX","GA","B-0114-14","Class II","Platelets Pheresis Leukocytes Reduced","W115113289387C",".","1 unit","Blood product, with a low platelet count, was distributed.",9/26/2013,"09/26/2013",12/26/2013,"12/26/2013"
"Biologics",66753,"Terminated","Community Blood Center of Carolinas","Charlotte","NC","US","Voluntary: Firm Initiated","Telephone","NC","B-0220-14","Class III","Red Blood Cells Leukocytes Reduced","W227013044949",".","1 unit","Blood product, which may have been exposed to unacceptable temperatures during storage, was distributed",10/1/2013,"10/01/2013",12/26/2013,"12/26/2013"
"Devices",66755,"Ongoing","Mindray DS USA, Inc. dba Mindray North America","Mahwah","NJ","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution - USA Nationwide","Z-0389-2014","Class II","Multi Parameter Patient Monitor (with Arrhythmia Detection and Alarms) Product Usage: The V Series Monitor is intended for intra hospital use under the direct supervision of a licensed healthcare practitioner. The indications for use for the V Series include the monitoring of the following human physiological parameters: 1) ECG waveform derived from 3, 5, 6 and 12 lead measurements 2) Heart Rate 3) Pulse Oximtery 4) ST Segment 5) Arrhythmia Detection 6) Non Invasive Blood Pressure (IBP) 7) Cardiac Output (CO) 8) Respiratory Gases 9) Respiration Rate 10) Temperature The V series monitor has the capability of performing IV Drug and Hemodynamic Calculations and interfacing with network devices. ","V Series Montor p/n 0998-00-1801-01 and the associated V Dock , p/n 0998-UC-180-01",".","1839 units","Mindray has identified an issue with V Series Monitor where the V Dock power pins connecting the V Series Monitor to the V Dock may lose spring tension, potentially causing the screen to temporarily go blank, lose communication with the central station monitor (when one is in use) or shut down. No patient related events have been reported to Mindray concerning the issue.",10/7/2013,"10/07/2013",12/4/2013,"12/04/2013"
"Food",66756,"Ongoing","Gourmet Express LLC","Greenville","KY","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Product was shipped to the following states: GA, IL, IN, MI & TN.","F-1131-2014","Class I","Bremer Garlic Shrimp MEAL IN MINUTES Pasta in Garlic Sauce with Broccoli, Shrimp, Corn and Carrots 21 oz bags, CONTAINS: WHEAT, MILK, CRUSTACEAN SHELLFISH (SHRIMP) Distributed by ALDI Inc., Batavia, IL 60510 0 41498-17223-7 3-cheese chicken & Chicken Lo Mein was recalled by USDA.","Lot #23921 Best By 4/30/2015",".","7,920/21 oz bags","The firm discovered a potential for undeclared egg in their Bremer Garlic Shrimp skillet meal.",11/1/2013,"11/01/2013",12/26/2013,"12/26/2013"
"Devices",66757,"Ongoing","Abbott Point Of Care Inc.","Princeton","NJ","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution - USA (nationwide) and Internationally to Argentina, Australia, Brazil, Chile, China, Finland, France, Germany, Greece, Hong Kong, Ireland, Italy, South Korea, Kuwait, Mexico, Netherland, New Zealand, Nigeria, Peru, Poland, Portugal, Qatar, Russia, Saudi Arabia, Singapore, south Africa, Spain, Sweden, Switzerland, Taiwan, Turkey, UAE, and United Kingdom,","Z-0451-2014","Class II","Abbott i-STAT PT/INR cartridges Abbott Point of Care Inc., Princeton, NJ 08540 The i-Stat PT a prothrombin time test is useful for monitoring patients receiving oral anticoagulation therapy such as Coumadin or Warfarin. The cartridge is to be used with the i-Stat 1 Analyzer and as part of the i-Stat System, the PT/INR test is to be used by trained health care professionals in accordance with a facility's policies and procedures.","K020355 List number 04J50-01, 04J50-02; 03P89-24 Lot number R13149A; R13151; R13151A and cartridge lots from C13139 up to and including C13270A",".","794,928 units US; 119,472 units OUS","Abbott Point of Care Inc (APOC) has determined that i-Stat PT/INR cartridges have the potential to exhibit incorrectly elevated INR.",10/28/2013,"10/28/2013",12/11/2013,"12/11/2013"
"Devices",66758,"Ongoing","CareFusion 303, Inc.","San Diego","CA","US","Voluntary: Firm Initiated","Letter","Nationwide Distribution.","Z-0435-2014","Class II","VersaSafe Extension Set, Model No. 21000M-007","Lot No. 13066550",".","3500 units","CareFusion is recalling the VersaSafe Extension Intravascular Administration Set because it may have excessive adhesive which will prevent the male spin collar to operate as intended.",11/8/2013,"11/08/2013",12/11/2013,"12/11/2013"
"Devices",66759,"Ongoing","CareFusion 303, Inc.","San Diego","CA","US","Voluntary: Firm Initiated","Letter","US Distribution in CA, WY, OH, UT, and MA.","Z-0450-2014","Class II","SmartSite Low Sorbing Infusion Set with Texium Close Male Luer, Model No. 24301-0007T The SmartSite Low Sorbing Infusion Sets with Texium Male Luer are used to administer fluid and medications through a needle or catheter inserted into the patient's artery or vein.","Lot No: 13046215 13046641 13056285 13056577 13075931",".","480 units","CareFusion is recalling the SmartSite Low Sorbing Infusion Set with Texium Closed Male Luer because it is not assembled with low-sorbing tubing.",11/8/2013,"11/08/2013",12/11/2013,"12/11/2013"
"Devices",66761,"Ongoing","Stryker Howmedica Osteonics Corp.","Mahwah","NJ","US","Voluntary: Firm Initiated","Letter","Nationwide Distribution including states: AL, GA, IL, and WA.","Z-0467-2014","Class II","1) Accolade II 127 Neck Angle Hip Stem, Size # 3 2) Accolade II 127 Neck Angle Hip Stem, Size #5 Howmedica Osteonics Corp. 325 Corporate Drive Mahwah, NJ 07430 USA Telephone # +1 201-831-5000 Stryker France ZAC Satolas Green Pusignan Av de Satolas Green 69881 MEYZIEU Cedex France Intended for cementless application in total or hemiarthroplasty procedures.","510K K120578 Accolade II I27 Neck Angle Hip Stem, Size # 3 Catalog No.# 6721-0330 Lot Code #44416307 Accolade II 127 Neck Angle Hip Stem, Size #5 Catalog No. # 6721-0535 Lot Code 44564405",,"20 units","Stryker received a report from the field indicating that an Accolade II Hip Stem Size #3 was identified in packaging with an Accolade II Hip Stem Size #5.",10/25/2013,"10/25/2013",12/18/2013,"12/18/2013"
"Devices",66763,"Ongoing","Synovis Surgical Innovations, Inc.","Saint Paul","MN","US","Voluntary: Firm Initiated","Letter","Nationwide Distribution.","Z-0339-2014","Class II","Dura Guard, Dural Repair Patch with Apex Processing. For use as a dura substitute for the closure of dura mater during neurosurgery. Product Code: DG0209SN DG0209SN DG0209SN DG0209SN DG0209SN DG0209SN DG0209SN DG0209SN DG0404SN DG0404SN DG0404SN DG0404SN DG0404SN DG0404SN DG0404SN DG0404SN DG0404SN DG0404SN DG0404SN DG0404SN DG0404SN DG0404SN DG0404SN DG0608SN DG0608SN DG0608SN DG0608SN DG0608SN DG0608SN DG0608SN DG0608SN DG0608SN DG0608SN DG0608SN DG0608SN DG0608SN DG0608SN DG0608SN DG0608SN DG0608SN DG0608SN DG0608SN ","Lot Numbers: SPCE113-03C0006 SPCE113-04D0002 SPCE113-04D0047 SPCE113-05E0052 SPCE113-05E0072 SPCE113-07G0077 SPCE113-08H0018 SPCE113-08H0073 SPCE113-03C0008 SPCE113-03C0072 SPCE113-04D0036 SPCE113-04D0092 SPCE113-04D0093 SPCE113-05E0047 SPCE113-05E0048 SPCE113-06F0053 SPCE113-06F0054 SPCE113-07G0008 SPCE113-07G0072 SPCE113-08H0016 SPCE113-FEB0092 SPCE113-JAN0046 SPCE113-JAN0106 SPCE113-03C0004 SPCE113-03C0069 SPCE113-03C0070 SPCE113-03C0071 SPCE113-04D0085 SPCE113-04D0086 SPCE113-05E0073 SPCE113-05E0074 SPCE113-06F0055 SPCE113-06F0057 SPCE113-06F0138 SPCE113-06F0139 SPCE113-07G0074 SPCE113-07G0075 SPCE113-08H0019 SPCE113-JAN0047 SPCE113-JAN0048 SPCE113-JAN0109 SPCE113-JAN0125 ",,"446 units","Synovis, a subsidiary of Baxter International Inc., is recalling certain shipments of VASCUGUARD and DURA-GUARD because Synovis, a subsidiary of Baxter International Inc., is recalling certain shipments of VASCUGUARD and DURA-GUARD because the shipping configurations in which the 6 fluid ounce units containing a specific revision of the Instructions for Use (IFU) shipped in a divided cell shipping carton can place pressure on the package, which can lead to damage and leakage. ",10/28/2013,"10/28/2013",11/27/2013,"11/27/2013"
"Devices",66763,"Ongoing","Synovis Surgical Innovations, Inc.","Saint Paul","MN","US","Voluntary: Firm Initiated","Letter","Nationwide Distribution.","Z-0338-2014","Class II","Vascu Guard, Peripheral Vascular Patch with Apex Processing. For use in peripheral vascular reconstruction. Product Code: VG0106N VG0106N VG0106N VG0106N VG0106N VG0106N VG0106N VG0106N VG0106N VG0106N VG0106N VG0106N VG0106N VG0106N VG0106N VG0106N VG0106N VG0106N VG0106N VG0106N VG0106N VG0106N VG0106N VG0106N VG0106N VG0106N VG0106N VG0106N VG0106N VG0108N VG0108N VG0108N VG0108N VG0108N VG0108N VG0108N VG0108N VG0108N VG0108N VG0108N VG0108N VG0108N VG0108N VG0108N VG0108N VG0108N VG0108N VG0108N VG0108N VG0108N VG0108N VG0108N VG0108N VG0108N VG0108N VG0108N VG0108N VG0108N VG0108N VG0108N VG0108N VG0108N VG0108N VG0108N VG0108N VG0108N VG0108N VG0108N VG0108N VG0108N VG0108N VG0108N VG0108N VG0108N VG0108N VG0108N VG0108N VG0108N VG0108N VG0108N VG0108N VG0108N VG0108N VG0108N VG0108N VG0108N VG0108N VG0108N VG0108N VG0108N VG0108N VG0108N VG0108N VG0108N VG0108N VG0108N VG0108N VG0108N VG0108N VG0108N VG0108N VG0108N VG0108N VG0108N VG0108N VG0108N VG0108N VG0108N VG0108N VG0108N VG0108N VG0108N VG0108N VG0108N VG0108N VG0108N VG0108N VG0108N VG0108N VG0108N VG0108N VG0108N VG0108N VG0108N VG0108N VG0108N VG0108N VG0108N VG0110N VG0110N VG0110N VG0110N VG0110N VG0110N VG0209N VG0209N VG0209N VG0209N VG0209N VG0209N VG0209N VG0209N VG0209N VG0209N VG0209N VG0209N ","Lot Numbers: SPCE113-03C0009 SPCE113-03C0067 SPCE113-03C0082 SPCE113-04D0001 SPCE113-04D0003 SPCE113-04D0028 SPCE113-04D0107 SPCE113-05E0032 SPCE113-05E0040 SPCE113-05E0065 SPCE113-05E0092 SPCE113-06F0001 SPCE113-06F0070 SPCE113-06F0071 SPCE113-06F0132 SPCE113-07G0001 SPCE113-07G0047 SPCE113-07G0099 SPCE113-07G0100 SPCE113-07G0116 SPCE113-08H0026 SPCE113-08H0057 SPCE113-FEB0002 SPCE113-FEB0029 SPCE113-JAN0091 SPCE113-JAN0092 SPCE113-JAN0099 SPCE113-JAN0104 SPCE113-JAN0133 SPCE113-03C0001 SPCE113-03C0002 SPCE113-03C0003 SPCE113-03C0022 SPCE113-03C0023 SPCE113-03C0024 SPCE113-03C0047 SPCE113-03C0062 SPCE113-03C0063 SPCE113-03C0064 SPCE113-03C0079 SPCE113-03C0080 SPCE113-03C0081 SPCE113-04D0020 SPCE113-04D0021 SPCE113-04D0032 SPCE113-04D0053 SPCE113-04D0054 SPCE113-04D0063 SPCE113-04D0098 SPCE113-04D0099 SPCE113-04D0108 SPCE113-04D0109 SPCE113-05E0029 SPCE113-05E0030 SPCE113-05E0031 SPCE113-05E0038 SPCE113-05E0039 SPCE113-05E0051 SPCE113-05E0054 SPCE113-05E0066 SPCE113-05E0080 SPCE113-05E0081 SPCE113-05E0082 SPCE113-05E0089 SPCE113-05E0093 SPCE113-06F0023 SPCE113-06F0058 SPCE113-06F0063 SPCE113-06F0064 SPCE113-06F0072 SPCE113-06F0073 SPCE113-06F0129 SPCE113-06F0130 SPCE113-06F0131 SPCE113-07G0003 SPCE113-07G0004 SPCE113-07G0016 SPCE113-07G0041 SPCE113-07G0042 SPCE113-07G0043 SPCE113-07G0044 SPCE113-07G0078 SPCE113-07G0079 SPCE113-07G0095 SPCE113-07G0103 SPCE113-07G0104 SPCE113-07G0111 SPCE113-07G0117 SPCE113-08H0034 SPCE113-08H0053 SPCE113-08H0054 SPCE113-08H0055 SPCE113-08H0056 SPCE113-08H0066 SPCE113-08H0067 SPCE113-08H0068 SPCE113-08H0069 SPCE113-08H0070 SPCE113-08H0081 SPCE113-09I0003 SPCE113-09I0012 SPCE113-09I0021 SPCE113-FEB0006 SPCE113-FEB0007 SPCE113-FEB0031 SPCE113-FEB0032 SPCE113-FEB0062 SPCE113-FEB0063 SPCE113-FEB0064 SPCE113-FEB0065 SPCE113-FEB0066 SPCE113-FEB0074 SPCE113-FEB0076 SPCE113-FEB0077 SPCE113-FEB0078 SPCE113-FEB0104 SPCE113-JAN0035 SPCE113-JAN0086 SPCE113-JAN0087 SPCE113",,"6014 units","Synovis, a subsidiary of Baxter International Inc., is recalling certain shipments of VASCUGUARD and DURA-GUARD because Synovis, a subsidiary of Baxter International Inc., is recalling certain shipments of VASCUGUARD and DURA-GUARD because the shipping configurations in which the 6 fluid ounce units containing a specific revision of the Instructions for Use (IFU) shipped in a divided cell shipping carton can place pressure on the package, which can lead to damage and leakage. ",10/28/2013,"10/28/2013",11/27/2013,"11/27/2013"
"Devices",66764,"Ongoing","Varian Medical Systems, Inc.","Palo Alto","CA","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution - USA Nationwide and in the countries of Algeria, Angola, Argentina, Australia, Austria, Azerbaijan, Bangladesh, Belgium, Belorussia, Bosnia and Herzegovina, Brazil, Bulgaria, Canada, Chile, China, Colombia, Costa Rica, Cyprus, Czech Republic, Denmark, Dominican Republic, Ecuador, Egypt, Estonia, Finland, France, French Polynesia, Georgia, Germany, Greece, Guadeloupe, Guam, Guatemala, Hong Kong, Hungary, India, Indonesia, Iraq, Ireland, Israel, Italy, Japan, Kazakhstan, Kenya, Kuwait, Latvia, Lebanon, Uthuania, luxembourg, Macau, Macedonia, Malaysia, Martinique, Mauritania, Mexico, Moldova, Monaco, Morocco, Netherlands, New Zealand, Norway, Oman, Pakistan, Panama, Paraguay, Peru, Philippines, Poland, Portugal, Puerto Rico, Qatar, Reunion, Romania, Russia, Saudi Arabia, Singapore, Slovakia, Slovenia, South Africa, South Korea, Spain, SriLanka, Sweden, Switzerland, Taiwan, Thailand, Trinidad and Tobago, Tunisia, Turkey, Ukraine, United Arab Emirates, United Kingdom, Venezuela, Vietnam, and Zimbabwe.","Z-0439-2014","Class II","C-Series: Clinac, Trilogy, Trilogy Tx. , Novalis high energy linear accelerators and UNIQUE single energy linear accelerator; Versions 7, 8 and 9. The UNIQUE is not sold in the US. Product Usage: The Varian High Energy Linear Accelerator is indicated for stereotactic radiosurgery and precision radiotherapy for lesions, tumors and conditions anywhere in the body when radiation treatment is indicated. The UNIQUE is a single energy medical linear accelerator. UNIQUE is indicated for precision radiotherapy for lesions, tumors and conditions anywhere in the body where radiation treatment is indicated.","Model numbers Hl4, HIS, H27, H29: Serial numbers: H140001 H140136 H140700 H140759 Hl40817 H140875 Hl40937 H140995 Hl82047 H271330 H271664 H271935 H272132 H140011 Hl40137 H140701 H140760 Hl40818 H140876 Hl40938 H140996 Hl82048 H271334 H271666 H271938 H272134 H140018 H140138 Hl40702 H140761 Hl40819 Hl40877 H140939 H140997 Hl82049 H271344 H271669 H271942 H272136 Hl40025 H140139 Hl40703 Hl40762 Hl40820 H140878 H140940 Hl40998 Hl82050 H271362 H271678 H271951 H272137 Hl40026 H140140 Hl40704 Hl40763 H140821 H140879 H140941 H140999 Hl820Sl H271370 H271681 H271954 H272138 Hl40027 Hl40141 Hl40705 Hl40764 H140822 Hl40880 H140942 Hl41000 Hl82054 H271378 H271691 H271958 H272143 H140029 H140142 Hl40706 Hl4076S H140823 H140881 H140943 Hl41001 Hl820SS H27138S H271693 H271959 H272144 Hl40036 H140143 Hl40707 Hl40766 H140824 H140882 H140944 H141002 H182056 H271393 H271711 H271961 H27214S H140038 H140144 H140708 H140767 H14082S H140883 H14094S H141003 Hl82057 H271398 H271712 H271964 H272146 H140039 H14014S H140709 H140768 H140826 H140884 H140946 H141004 Hl82058 H271407 H271713 H271966 H272150 H140043 H140146 H140710 H140769 H140827 H14088S H140947 H141005 Hl82060 H271413 H271714 H271972 H272153 Hl4004S H140147 H140711 H140770 Hl40828 H140886 H140948 H141007 H182061 H271414 H271724 H271973 H272155 Hl40046 H140148 H140712 H140771 H140829 H140888 H140949 H141009 H182062 H271420 H271729 H271974 H272156 H140047 H140150 H140713 H140772 H140830 H140889 H1409SO H141010 Hl82063 H271425 H271742 H271975 H272157 H140048 H140151 H140714 H140773 H140831 H140890 H140951 H141011 H182064 H271429 H271755 H271987 H272158 H140058 H140152 H140715 Hl40774 H140832 H140891 H140952 H141015 H182066 H271438 H271760 H271993 H272159 H140062 H140153 Hl40716 H140775 H140833 H140892 H140953 H141017 Hl82067 H271439 H271762 H271994 H272162 H140067 H140154 H140717 H140776 H140834 H140893 H140954 H141022 Hl82068 H271443 H271763 H272001 H272163 Hl40069 Hl40201 H140718 H140777 H140835 H140895 H140955 H182000 Hl82072 H271452 H271773 H272003 H272168 H140070 H140202 Hl4",".","3,809 devices","This correction is to notify users that a solution to a previous correction has been developed and Varians reps will be contacting locations to schedule installation.",10/24/2013,"10/24/2013",12/11/2013,"12/11/2013"
"Food",66765,"Ongoing","Global Health Laboratories, LLC","Amityville","NY","US","Voluntary: Firm Initiated","Letter","New York","F-1105-2014","Class II","UT-Fem FOR WOMEN, urinary tract SOLUTION, Dietary Supplement, 42 Vegetable Capsules, Product No. 110403, UPC 7 98304 24865 4 -- Manufactured for: Global Quality Health Inc. ","Lot Number 1256074",".","1495 bottles","The finished dietary supplement product was manufactured with ingredients subsequently found to be contaminated with chloramphenicol, an antibiotic, at levels above 0.3 ppb. The supplier, Specialty Enzymes & Biotechnologies, recalled the raw materials and notified the recipients. Subsequent private laboratory testing of the finished product revealed levels of chloramphenicol above 0.3 ppb. ",11/7/2013,"11/07/2013",12/26/2013,"12/26/2013"
"Food",66766,"Ongoing","Global Health Laboratories, LLC","Amityville","NY","US","Voluntary: Firm Initiated","Letter","Arizona","F-1112-2014","Class II","(a) ONEBODE Flo daily, probiotic enzyme digestive, 90 capsules, dietary supplement, Product No. T00135, UPC 0 14834 00135 5; (b) ONEBODE Flo for Family, probiotic enzyme digestive, 360 capsules, dietary supplement, Product No. T00109, UPC 0 14834 00109 6; (c) ONEBODE Flo daily, probiotic enzyme digestive, 6 capsules, dietary supplement (SAMPLE PACK), Product No. T00111, UPC 0 14834 00111 9 --- Mfg. for OneBode, Chandler, Arizona 85226","(a) Lot Number 1262057; (b) Lot Number 1262058; (c) Lot Numbers 26813, 26813A, 26813B",".","Lot 1262057: 1985 bottles; Lot 1262058: 489 bottles; Sample packs: 11,276 units","The finished dietary supplement product was manufactured with ingredients found to be contaminated with chloramphenicol, an antibiotic, above levels of 0.3 ppb.",11/7/2013,"11/07/2013",12/26/2013,"12/26/2013"
"Biologics",66767,"Terminated","LifeSouth Community Blood Centers Inc","Madison","AL","US","Voluntary: Firm Initiated","FAX","AL","B-0115-14","Class II","Platelets Pheresis Leukocytes Reduced","W1151132210536- part 1; W1151132210536-part 2 ",".","2 units","Blood products, not prepared in accordance with specifications, were distributed.",9/8/2013,"09/08/2013",12/26/2013,"12/26/2013"
"Biologics",66768,"Terminated","Lifesouth Community Blood Centers - Montgomery Region","Montgomery","AL","US","Voluntary: Firm Initiated","FAX","AL","B-0196-14","Class II","Platelets Pheresis Leukocytes Reduced","W1151132312229-part 1; W1151132312229- part 2; W1151132312229-part 3 ",".","3 units","Blood products, with a low platelet count, were distributed.",8/2/2013,"08/02/2013",12/26/2013,"12/26/2013"
"Devices",66773,"Ongoing","Candela Corporation","Wayland","MA","US","Voluntary: Firm Initiated","Letter","Worldwide distribution: US (nationwide) and Internationally to: Azerbaijan, Bulgaria, Chile, Czech Republic, Greece, Israel, Kuwait, Qatar, Saudi Arabia, Serbia, Turkey, and the United Arab Emirates and to Subsidiaries in Australia, France, Germany, Italy, Japan, Portugal, Spain, and the United Kingdom.","Z-0348-2014","Class II","Candela Laser GentleLase Pro, Powered Laser Surgical Instrument for dermatological use - Model number: 9914-00-9015. and Candela Laser GentleLase Pro LE, Model number: 9914-00-9040","GL Pro Model 9914-00-9015:: SN 9914-9015-0005 through 9914-9015-1259 GL Pro LE Model 9914-00-9040: SN 9914-9040-0716 through 9914-9040-1214 ",," 1258 units","Unintended single pulse maybe emitted to handpiece prior to pressing of trigger or footswitch and cause injury.",11/6/2013,"11/06/2013",11/27/2013,"11/27/2013"
"Biologics",66781,"Terminated","DCI Biologicals Hot Springs, Inc","Hot Springs National Park","AR","US","Voluntary: Firm Initiated","FAX","United Kingdom","B-0218-14","Class III","Source Plasma","HS0301473; HS0301715; HS0307866; HS0335910; HS0336124; HS0308613",".","6 units","Blood products, collected from a donor in which donor suitability was not adequately determined, were distributed.",9/27/2013,"09/27/2013",12/26/2013,"12/26/2013"
"Biologics",66782,"Terminated","Joliet Blood Plasma LLC dba Plasma Care, Inc.","Joliet","IL","US","Voluntary: Firm Initiated","FAX","Spain","B-0217-14","Class III","Source Plasma","2600216438; 2600214347 ",".","2 units","Blood products, collected from a donor in which donor suitability was not adequately determined, were distributed",9/14/2013,"09/14/2013",12/26/2013,"12/26/2013"
"Veterinary",66789,"Ongoing","BioMatrix, Inc.","Princeton","MN","US","Voluntary: Firm Initiated","E-Mail","IA","V-009-2014","Class II","Gourley Brothers LC, Pig Enzyme Pack 8184, For use in Manufacturing of Animal Feeds Only. Guaranteed Analysis: Phytase, Min 1,500 FTU/gram, Xylanase, Min 800 HSU/gram, Protease, Min 6,000 HUT /gram. Ingredients: Calcium Carbonate, roughage products, dried Aspergillus oryae and Trichoderma reesei fermentation extract, Schizosacharomyces pombe fermentation extract, and soy oil. Manufactured for Gourley Brothers LC, 2970 Inkpaduta Ave, Webster City, IA 50595. Net Weight : 50 lbs (22.68 kg)","Lot 46989",".","1,500 lb","BioMatrix International has been notified by their supplier (Bio-Cat,Inc,Troy,VA) of the contamination of an enzyme product with the antibiotic chloramphenicol. The product is used in the production of a low inclusion animal feed supplement for swine ( Pig Enzyme Pack).",9/27/2013,"09/27/2013",12/11/2013,"12/11/2013"
"Devices",66790,"Ongoing","Trumpf Medical Systems, Inc.","Charleston","SC","US","Voluntary: Firm Initiated","Letter","US Distribution including the states of AR, CA, CO, KS, MA, MI, MO, NJ, NY, NC, OH, OK, PA, SD, TX and WA.","Z-0484-2014","Class II","Helion S Exam Light or H300 The device is intended to locally illuminate an examination area of the patient's body with high intensity light in a clinic or doctor's practice.","Unknown",,"287"," Possible fatigue failure of the plastic joint may occur after an average use of seven years.",2/19/2013,"02/19/2013",12/18/2013,"12/18/2013"
"Drugs",66791,"Ongoing","Sandoz Inc","Wilson","NC","US","Voluntary: Firm Initiated","Letter","Nationwide","D-341-2014","Class III","Bumetanide Tablets USP 0.5 mg. Rx Only, a) 100-count Bottle, b) 500-count Bottle, Sandoz Inc., Princeton, NJ 08540, NDC a) 0185-0128-01, b) 0185-0128-05","Lot #: a) CU6131, b) CW1161 ",,"11,496 bottles (100 count) and 62 bottles (500 count)","Failed Moisture Limit; Out of Specification (OOS) results were obtained for moisture content during stability testing at the 12 month time point, controlled room temperature conditions.",11/6/2013,"11/06/2013",12/18/2013,"12/18/2013"
"Devices",66792,"Ongoing","Biomet, Inc.","Warsaw","IN","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution: USA (nationwide) and Internationally to Japan.","Z-0381-2014","Class II","REF 200068 Security (TM) Enclosed Carpal Tunnel System Blade ( Single) ABS /Stainless Steel Sterile Device, Single Use Only. Designed to release the transverse carpal ligament.","Catalog Number: 200068 Medical Device Listing Number: B008657 Lot Number Identification: 088610, 090600, 143810, 257060, 289900, 365910, 460490, 558300, 626660, 697320,767260,795090,857730,864640,979680",".","1130"," Security Blades were manufactured oversized and potentially won't advance or may be difficult to advance through the mating Security Clip. ",10/25/2013,"10/25/2013",12/4/2013,"12/04/2013"
"Food",66793,"Ongoing","ProThera, Inc.","Reno","NV","US","Voluntary: Firm Initiated","Letter","US and Canada, Germany, Great Britain, Hong Kong, Malaysia, Mexico, Philippines, Russia, Singapore, South Korea , Spain","F-0180-2014","Class II","Pro Thera Dual Detox Dietary Supplement; 60 capsules; Chlorella - 500 mg; Broccoli Sprout, dried extract - 60 mg; Enzyme Blend - supplying Beta-Glucanase, Cellulase, Protease, Hemicellulase, Phytase and Xylanase Manufactured by ProThera, Reno, NV,","Lot B3222, product code DTX",,"54, 503 capsules","Firm was notified by supplier of the enzyme Xylanase that it was contaminated with chloramphenicol.",11/6/2013,"11/06/2013",11/27/2013,"11/27/2013"
"Food",66793,"Ongoing","ProThera, Inc.","Reno","NV","US","Voluntary: Firm Initiated","Letter","US and Canada, Germany, Great Britain, Hong Kong, Malaysia, Mexico, Philippines, Russia, Singapore, South Korea , Spain","F-0179-2014","Class II","Lifeforce Medical Institute Ultra Power; Optimal Vitamin/Mi neral. Trace Element/Anti-Oxidant Detox Support Dietary Supplement. 10 tablets/Packet and 30 packets/1000cc bottle. Distributed by: Mark Rosenbloom, MD LIFEFORCE Medical Institute 60 Revere Dr., Ste. 820 Northbrook, IL 60062 (847) 905-9505 www.lifeforcemed.com","361849A, Product code CT-80924A",,"48,000 capsules","Firm was notified by supplier of the enzyme Xylanase that it was contaminated with chloramphenicol.",11/6/2013,"11/06/2013",11/27/2013,"11/27/2013"
"Food",66794,"Ongoing","A&C US Trading LLC","New York","NY","US","Voluntary: Firm Initiated","Letter","NY","F-0844-2014","Class II","Lam Sheng Kee HAW FLAKES, NET WEIGHT 380 g (13.4 oz), product is packaged in plastic bag with twenty four (24) bags per carton. UPC 6 949682 803780. Manufactured by LAM SHENG KEE (HK) INTERNATIONAL LIMITED, RM3/8F., YUEXIU BLDG., 160-174 LOCKHART ROAD, WAN CHAI, HK. Distributed by: WIN LUCK TRADING INC 100 Pulaski Street Bayonne, NJ 07002. Product of China.","ITEM NO.: 803780, Best Before 12/30/2014",".","600 cartons","A&C US Trading LLC., has recalled Haw Flakes due to use of unapproved food coloring.",10/23/2013,"10/23/2013",12/26/2013,"12/26/2013"
"Food",66795,"Ongoing"," Plum Inc ","Emeryville","CA","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Nationwide and to Korea, China, Mexico, Hong Kong, Singapore, Malaysia, Costa Rica, jordan, Bermuda, Indonesia and United Kingdom","F-0352-2014","Class II","Plum Organics Peach, Apricot & Banana Organic Baby Food, 4 oz. pouch. Flexible pouch with resealable spout. Packaged for individual sale in 6 count cartons and in 4 count packages. Best By dates ranging from 08/05/14 to 12/08/14 and the letters AT. DISTRIBUTED BY: NEST COLLECTIVE, INC. EMERYVILLE, CA 94608 1-877-914-PLUM WWW.NEST-COLLECTIVE.COM","Item number 873 Selling Unit UPC: 890180001214; Case UPC: 846675000873 Best By dates ranging from 08/05/14 to 12/08/14 and the letters AT. ",".","597,827 cases, all varieties","Manufacturing defect leading to post-process contamination.",11/8/2013,"11/08/2013",12/4/2013,"12/04/2013"
"Food",66795,"Ongoing"," Plum Inc ","Emeryville","CA","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Nationwide and to Korea, China, Mexico, Hong Kong, Singapore, Malaysia, Costa Rica, jordan, Bermuda, Indonesia and United Kingdom","F-0374-2014","Class II","Plum Organics Pumpkin, Dates, Oats & Chia Organic Baby Food- 3.5 oz. Pouch Flexible pouch with Resealable spout. Packaged for individual sale in 6 count cartons and in 4 count packages. Best By dates ranging from 08/05/14 to 12/08/14 and the letters AT. DISTRIBUTED BY: NEST COLLECTIVE, INC. EMERYVILLE, CA 94608 1-877-914-PLUM WWW.NEST-COLLECTIVE.COM","Item number 80007: Selling Unit UPC; 846675003775 Case UPC:00846675003850 Best By dates ranging from 08/05/14 to 12/08/14 and the letters AT. ",".","597,827 total cases, all varieties.","Manufacturing defect leading to post-process contamination.",11/8/2013,"11/08/2013",12/4/2013,"12/04/2013"
"Food",66795,"Ongoing"," Plum Inc ","Emeryville","CA","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Nationwide and to Korea, China, Mexico, Hong Kong, Singapore, Malaysia, Costa Rica, jordan, Bermuda, Indonesia and United Kingdom","F-0372-2014","Class II","Plum Kids Mixed Berry Mashups, 10 ct. Club Pack. Flexible pouch with Resealable spout. Packaged for individual sale in 6 count cartons and in 4 count packages. Best By dates ranging from 08/05/14 to 12/08/14 and the letters AT. DISTRIBUTED BY: NEST COLLECTIVE, INC. EMERYVILLE, CA 94608 1-877-914-PLUM WWW.NEST-COLLECTIVE.COM","Item number 2839: Selling Unit UPC; 846675002839 Case UPC: NA. Best By dates ranging from 08/05/14 to 12/08/14 and the letters AT. ",".","597,827 total cases, all varieties.","Manufacturing defect leading to post-process contamination.",11/8/2013,"11/08/2013",12/4/2013,"12/04/2013"
"Food",66795,"Ongoing"," Plum Inc ","Emeryville","CA","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Nationwide and to Korea, China, Mexico, Hong Kong, Singapore, Malaysia, Costa Rica, jordan, Bermuda, Indonesia and United Kingdom","F-0359-2014","Class II","Plum Organics Cherry & Sweet Corn Organic Baby Food, 4 oz. pouch. Flexible pouch with Resealable spout. Packaged for individual sale in 6 count cartons and in 4 count packages. Best By dates ranging from 08/05/14 to 12/08/14 and the letters AT. DISTRIBUTED BY: NEST COLLECTIVE, INC. EMERYVILLE, CA 94608 1-877-914-PLUM WWW.NEST-COLLECTIVE.COM","Item number 1382: Selling Unit UPC: 846675001344 ; Case UPC:846675001382 ; Best By dates ranging from 08/05/14 to 12/08/14 and the letters AT. ",".","597,827 cases total, all varieties.","Manufacturing defect leading to post-process contamination.",11/8/2013,"11/08/2013",12/4/2013,"12/04/2013"
"Food",66795,"Ongoing"," Plum Inc ","Emeryville","CA","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Nationwide and to Korea, China, Mexico, Hong Kong, Singapore, Malaysia, Costa Rica, jordan, Bermuda, Indonesia and United Kingdom","F-0370-2014","Class II","Plum Kids Blueberry Blitz Fruit & Veggie Mashups, 12.69 oz. box. Flexible pouch with Resealable spout. Packaged for individual sale in 6 count cartons and in 4 count packages. Best By dates ranging from 08/05/14 to 12/08/14 and the letters AT. DISTRIBUTED BY: NEST COLLECTIVE, INC. EMERYVILLE, CA 94608 1-877-914-PLUM WWW.NEST-COLLECTIVE.COM","Item number 1856: Selling Unit UPC; 846675001665 Case UPC:846675001856. Best By dates ranging from 08/05/14 to 12/08/14 and the letters AT. ",".","597,827 total cases, all varieties.","Manufacturing defect leading to post-process contamination.",11/8/2013,"11/08/2013",12/4/2013,"12/04/2013"
"Food",66795,"Ongoing"," Plum Inc ","Emeryville","CA","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Nationwide and to Korea, China, Mexico, Hong Kong, Singapore, Malaysia, Costa Rica, jordan, Bermuda, Indonesia and United Kingdom","F-0357-2014","Class II","Plum Organics Tots Purple Roots and Fruits Yogurt Mish Mash; 3.17 oz. Pouch; Also 12.69 oz. box. Flexible pouch with Resealable spout. Packaged for individual sale in 6 count cartons and in 4 count packages. Best By dates ranging from 08/05/14 to 12/08/14 and the letters AT. DISTRIBUTED BY: NEST COLLECTIVE, INC. EMERYVILLE, CA 94608 1-877-914-PLUM WWW.NEST-COLLECTIVE.COM","Item number 1269 - pouch Selling Unit UPC: 846675000996 ; Case UPC: 846675001269; Item number: 1528 - box; Selling unit UPC: 846675001467; Case UPC: 846675001528. Best By dates ranging from 08/05/14 to 12/08/14 and the letters AT. ",".","597,827 total cases, all varieties","Manufacturing defect leading to post-process contamination.",11/8/2013,"11/08/2013",12/4/2013,"12/04/2013"
"Food",66795,"Ongoing"," Plum Inc ","Emeryville","CA","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Nationwide and to Korea, China, Mexico, Hong Kong, Singapore, Malaysia, Costa Rica, jordan, Bermuda, Indonesia and United Kingdom","F-0353-2014","Class II","Plum Organics Sweet Potato, Mango & Millet Organic Baby Food; 3.5 oz. Pouch; Flexible pouch with Resealable spout. Packaged for individual sale in 6 count cartons and in 4 count packages. Best By dates ranging from 08/05/14 to 12/08/14 and the letters AT. DISTRIBUTED BY: NEST COLLECTIVE, INC. EMERYVILLE, CA 94608 1-877-914-PLUM WWW.NEST-COLLECTIVE.COM","Item number 1214: Selling Unit UPC: 846675001047; Case UPC: 846675001214; Item 80020: Selling Unit UPC: 846675001047; Case UPC:846675001214 Best By dates ranging from 08/05/14 to 12/08/14 and the letters AT. ",".","597,827 cases, all varieties","Manufacturing defect leading to post-process contamination.",11/8/2013,"11/08/2013",12/4/2013,"12/04/2013"
"Food",66795,"Ongoing"," Plum Inc ","Emeryville","CA","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Nationwide and to Korea, China, Mexico, Hong Kong, Singapore, Malaysia, Costa Rica, jordan, Bermuda, Indonesia and United Kingdom","F-0376-2014","Class II","Plum Organics Mango, Carrot & Greek Yogurt Organics Baby Food- 3.5 oz. Pouch Flexible pouch with Resealable spout. Packaged for individual sale in 6 count cartons and in 4 count packages. Best By dates ranging from 08/05/14 to 12/08/14 and the letters AT. DISTRIBUTED BY: NEST COLLECTIVE, INC. EMERYVILLE, CA 94608 1-877-914-PLUM WWW.NEST-COLLECTIVE.COM","Item number 80009; Selling Unit UPC; 846675003751 Case UPC:00846675003836 UK Export only: Item number MCG18U: Selling Unit UPC5060116891607: Case UPC:5060116897753 Best By dates ranging from 08/05/14 to 12/08/14 and the letters AT. ",".","597,827 total cases, all products.","Manufacturing defect leading to post-process contamination.",11/8/2013,"11/08/2013",12/4/2013,"12/04/2013"
"Food",66795,"Ongoing"," Plum Inc ","Emeryville","CA","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Nationwide and to Korea, China, Mexico, Hong Kong, Singapore, Malaysia, Costa Rica, jordan, Bermuda, Indonesia and United Kingdom","F-0362-2014","Class II","Plum Organics Tots Blueberry Oats & Quinoa Morning Mish Mash - 12.79 oz. box. Flexible pouch with Resealable spout. Packaged for individual sale in 6 count cartons and in 4 count packages. Best By dates ranging from 08/05/14 to 12/08/14 and the letters AT. DISTRIBUTED BY: NEST COLLECTIVE, INC. EMERYVILLE, CA 94608 1-877-914-PLUM WWW.NEST-COLLECTIVE.COM","Item number 1498: Selling Unit UPC:846675001436; Case UPC:846675001498. Best By dates ranging from 08/05/14 to 12/08/14 and the letters AT. ",".","597,827 total cases, all varieties.","Manufacturing defect leading to post-process contamination.",11/8/2013,"11/08/2013",12/4/2013,"12/04/2013"
"Food",66795,"Ongoing"," Plum Inc ","Emeryville","CA","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Nationwide and to Korea, China, Mexico, Hong Kong, Singapore, Malaysia, Costa Rica, jordan, Bermuda, Indonesia and United Kingdom","F-0354-2014","Class II","Plum Organics Apple Raisin & Quinona Organic Baby Food; 3.5 oz. Pouch; Flexible pouch with Resealable spout. Packaged for individual sale in 6 count cartons and in 4 count packages. Best By dates ranging from 08/05/14 to 12/08/14 and the letters AT. DISTRIBUTED BY: NEST COLLECTIVE, INC. EMERYVILLE, CA 94608 1-877-914-PLUM WWW.NEST-COLLECTIVE.COM","Item number1221: Selling Unit UPC: 846675001054; Case UPC: 846675001221; Best By dates ranging from 08/05/14 to 12/08/14 and the letters AT. ",".","587,827 cases, all varieties","Manufacturing defect leading to post-process contamination.",11/8/2013,"11/08/2013",12/4/2013,"12/04/2013"
"Food",66795,"Ongoing"," Plum Inc ","Emeryville","CA","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Nationwide and to Korea, China, Mexico, Hong Kong, Singapore, Malaysia, Costa Rica, jordan, Bermuda, Indonesia and United Kingdom","F-0373-2014","Class II","Plum Organics Blueberry, Parsnip & Buckwheat Organic Baby Food- 3.5 oz. Pouch . Flexible pouch with Resealable spout. Packaged for individual sale in 6 count cartons and in 4 count packages. Best By dates ranging from 08/05/14 to 12/08/14 and the letters AT. DISTRIBUTED BY: NEST COLLECTIVE, INC. EMERYVILLE, CA 94608 1-877-914-PLUM WWW.NEST-COLLECTIVE.COM","Item number 80006: Selling Unit UPC; 846675003782 Case UPC:00846675003867 . Best By dates ranging from 08/05/14 to 12/08/14 and the letters AT. ",".","597,827 total cases, all varieties","Manufacturing defect leading to post-process contamination.",11/8/2013,"11/08/2013",12/4/2013,"12/04/2013"
"Food",66795,"Ongoing"," Plum Inc ","Emeryville","CA","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Nationwide and to Korea, China, Mexico, Hong Kong, Singapore, Malaysia, Costa Rica, jordan, Bermuda, Indonesia and United Kingdom","F-0363-2014","Class II","Plum Organics Spinach, Peas & Pear Organic Baby Food, 4 oz. pouch.. Flexible pouch with Resealable spout. Packaged for individual sale in 6 count cartons and in 4 count packages. Best By dates ranging from 08/05/14 to 12/08/14 and the letters AT. DISTRIBUTED BY: NEST COLLECTIVE, INC. EMERYVILLE, CA 94608 1-877-914-PLUM WWW.NEST-COLLECTIVE.COM","Item number 1566: Selling Unit UPC:890180001191; Case UPC:890180001566. Best By dates ranging from 08/05/14 to 12/08/14 and the letters AT. ",".","597,827 total cases, all varieties.","Manufacturing defect leading to post-process contamination.",11/8/2013,"11/08/2013",12/4/2013,"12/04/2013"
"Food",66795,"Ongoing"," Plum Inc ","Emeryville","CA","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Nationwide and to Korea, China, Mexico, Hong Kong, Singapore, Malaysia, Costa Rica, jordan, Bermuda, Indonesia and United Kingdom","F-0351-2014","Class II","Plum Organics Broccoli & Apple Organic Baby Food, 4 oz. pouch; Flexible pouch with Re-sealable spout. Packaged for individual sale in 6 count cartons and in 4 count packages. Best By dates ranging from 08/05/14 to 12/08/14 and the letters AT. DISTRIBUTED BY: NEST COLLECTIVE, INC. EMERYVILLE, CA 94608 1-877-914-PLUM WWW.NEST-COLLECTIVE.COM","Item number 866 Selling Unit UPC: 846675000538; Case UPC:846675000866; Item number 80016; Selling Unit UPC: 846675000538 Case UPC 846675003935 Best By dates ranging from 08/05/14 to 12/08/14 and the letters AT. ",".","597,827 cases, all varieties","Manufacturing defect leading to post-process contamination.",11/8/2013,"11/08/2013",12/4/2013,"12/04/2013"
"Food",66795,"Ongoing"," Plum Inc ","Emeryville","CA","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Nationwide and to Korea, China, Mexico, Hong Kong, Singapore, Malaysia, Costa Rica, jordan, Bermuda, Indonesia and United Kingdom","F-0368-2014","Class II","Plum Organics Apple & Carrot Organic Baby Food, 4.0 oz. pouch.. Flexible pouch with Resealable spout. Packaged for individual sale in 6 count cartons and in 4 count packages. Best By dates ranging from 08/05/14 to 12/08/14 and the letters AT. DISTRIBUTED BY: NEST COLLECTIVE, INC. EMERYVILLE, CA 94608 1-877-914-PLUM WWW.NEST-COLLECTIVE.COM","Item number 1634: Selling Unit UPC:890180001221; Case UPC:890180001634. Item 80018; Selling Unit UPC:890180001221; Case UPC: 890180003997 Best By dates ranging from 08/05/14 to 12/08/14 and the letters AT. ",".","597,827 total cases, all varieties.","Manufacturing defect leading to post-process contamination.",11/8/2013,"11/08/2013",12/4/2013,"12/04/2013"
"Food",66795,"Ongoing"," Plum Inc ","Emeryville","CA","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Nationwide and to Korea, China, Mexico, Hong Kong, Singapore, Malaysia, Costa Rica, jordan, Bermuda, Indonesia and United Kingdom","F-0379-2014","Class II","Courgette Banana & Amaranth Flexible pouch with Resealable spout. Packaged for individual sale in 6 count cartons and in 4 count packages. Best By dates ranging from 08/05/14 to 12/08/14 and the letters AT. DISTRIBUTED BY: NEST COLLECTIVE, INC. EMERYVILLE, CA 94608 1-877-914-PLUM WWW.NEST-COLLECTIVE.COM","UK Export only Item number CBA11U; Selling Unit UPC; 5060116891638 Case UPC:5060116897784 Best By dates ranging from 08/05/14 to 12/08/14 and the letters AT. ",".","597,827 cases, all varieties","Manufacturing defect leading to post-process contamination.",11/8/2013,"11/08/2013",12/4/2013,"12/04/2013"
"Food",66795,"Ongoing"," Plum Inc ","Emeryville","CA","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Nationwide and to Korea, China, Mexico, Hong Kong, Singapore, Malaysia, Costa Rica, jordan, Bermuda, Indonesia and United Kingdom","F-0367-2014","Class II","Plum Organics Pear and Mango Organic Baby Food, 4.0 oz. pouch.. Flexible pouch with Resealable spout. Packaged for individual sale in 6 count cartons and in 4 count packages. Best By dates ranging from 08/05/14 to 12/08/14 and the letters AT. DISTRIBUTED BY: NEST COLLECTIVE, INC. EMERYVILLE, CA 94608 1-877-914-PLUM WWW.NEST-COLLECTIVE.COM","Item number 1610: Selling Unit UPC:890180001207; Case UPC: 890180001610. Best By dates ranging from 08/05/14 to 12/08/14 and the letters AT. ",".","597,827 total cases, all varieties.","Manufacturing defect leading to post-process contamination.",11/8/2013,"11/08/2013",12/4/2013,"12/04/2013"
"Food",66795,"Ongoing"," Plum Inc ","Emeryville","CA","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Nationwide and to Korea, China, Mexico, Hong Kong, Singapore, Malaysia, Costa Rica, jordan, Bermuda, Indonesia and United Kingdom","F-0361-2014","Class II","Plum Organics Raspberry, Spinach & Greek Yogurt Organic Baby Food, 4 oz. pouch. Flexible pouch with Resealable spout. Packaged for individual sale in 6 count cartons and in 4 count packages. Best By dates ranging from 08/05/14 to 12/08/14 and the letters AT. DISTRIBUTED BY: NEST COLLECTIVE, INC. EMERYVILLE, CA 94608 1-877-914-PLUM WWW.NEST-COLLECTIVE.COM","Item number 1405: Selling Unit UPC:846675001320; Case UPC846675001405; Item number: 80024; Selling Unit UPC:846675001320 Case UPC: 846675004000 UK Export only Item number RSG18U Sellling unit UPC: 5060116891591 Case UPC: 5060116897746 Best By dates ranging from 08/05/14 to 12/08/14 and the letters AT. ",".","597,827 total cases, all varieties.","Manufacturing defect leading to post-process contamination.",11/8/2013,"11/08/2013",12/4/2013,"12/04/2013"
"Food",66795,"Ongoing"," Plum Inc ","Emeryville","CA","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Nationwide and to Korea, China, Mexico, Hong Kong, Singapore, Malaysia, Costa Rica, jordan, Bermuda, Indonesia and United Kingdom","F-0365-2014","Class II","Plum Organics Blueberry, Pear and Purple Carrot Organic Baby Food, 4 oz. pouch.. Flexible pouch with Resealable spout. Packaged for individual sale in 6 count cartons and in 4 count packages. Best By dates ranging from 08/05/14 to 12/08/14 and the letters AT. DISTRIBUTED BY: NEST COLLECTIVE, INC. EMERYVILLE, CA 94608 1-877-914-PLUM WWW.NEST-COLLECTIVE.COM","Item number 1580: Selling Unit UPC:890180001979 Case UPC: 890180001580 Item number 80015: Selling Unit UPC:890180001979 Case UPC: 846675003928 Best By dates ranging from 08/05/14 to 12/08/14 and the letters AT. ",".","597,827 total cases, all varieties.","Manufacturing defect leading to post-process contamination.",11/8/2013,"11/08/2013",12/4/2013,"12/04/2013"
"Food",66795,"Ongoing"," Plum Inc ","Emeryville","CA","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Nationwide and to Korea, China, Mexico, Hong Kong, Singapore, Malaysia, Costa Rica, jordan, Bermuda, Indonesia and United Kingdom","F-0358-2014","Class II","Plum Organics Tots Berry, Banana, Beet Yogurt Mish Mash; 3.17 oz. Pouch; also in 12.69 oz. box. Flexible pouch with Resealable spout. Packaged for individual sale in 6 count cartons and in 4 count packages. Best By dates ranging from 08/05/14 to 12/08/14 and the letters AT. DISTRIBUTED BY: NEST COLLECTIVE, INC. EMERYVILLE, CA 94608 1-877-914-PLUM WWW.NEST-COLLECTIVE.COM","Item number 1276: pouch Selling Unit UPC: 846675001009 ; Case UPC:846675001276 ; Item number: 1511 - box Selling Units UPC:846675001450 ; Case UPC: 846675001511 Best By dates ranging from 08/05/14 to 12/08/14 and the letters AT. ",".","597,827 total cases, all varieties","Manufacturing defect leading to post-process contamination.",11/8/2013,"11/08/2013",12/4/2013,"12/04/2013"
"Food",66795,"Ongoing"," Plum Inc ","Emeryville","CA","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Nationwide and to Korea, China, Mexico, Hong Kong, Singapore, Malaysia, Costa Rica, jordan, Bermuda, Indonesia and United Kingdom","F-0360-2014","Class II","Plum Organics Green Bean, Pear & Greek Yogurt Organic Baby Food, 4 oz. pouch. Flexible pouch with Resealable spout. Packaged for individual sale in 6 count cartons and in 4 count packages. Best By dates ranging from 08/05/14 to 12/08/14 and the letters AT. DISTRIBUTED BY: NEST COLLECTIVE, INC. EMERYVILLE, CA 94608 1-877-914-PLUM WWW.NEST-COLLECTIVE.COM","Item number 1399: Selling Unit UPC:846675001337; Case UPC:846675001399 ; Best By dates ranging from 08/05/14 to 12/08/14 and the letters AT. ",".","597,827 total cases, all varieties","Manufacturing defect leading to post-process contamination.",11/8/2013,"11/08/2013",12/4/2013,"12/04/2013"
"Food",66795,"Ongoing"," Plum Inc ","Emeryville","CA","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Nationwide and to Korea, China, Mexico, Hong Kong, Singapore, Malaysia, Costa Rica, jordan, Bermuda, Indonesia and United Kingdom","F-0371-2014","Class II","Plum Kids Tropical Fruit Mashups, 12.69 oz. box. Flexible pouch with Resealable spout. Packaged for individual sale in 6 count cartons and in 4 count packages. Best By dates ranging from 08/05/14 to 12/08/14 and the letters AT. DISTRIBUTED BY: NEST COLLECTIVE, INC. EMERYVILLE, CA 94608 1-877-914-PLUM WWW.NEST-COLLECTIVE.COM","Item number 1894: Selling Unit UPC; 846675001818 Case UPC:846675001894. Best By dates ranging from 08/05/14 to 12/08/14 and the letters AT. ",".","597,827 total cases, all varieties.","Manufacturing defect leading to post-process contamination.",11/8/2013,"11/08/2013",12/4/2013,"12/04/2013"
"Food",66795,"Ongoing"," Plum Inc ","Emeryville","CA","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Nationwide and to Korea, China, Mexico, Hong Kong, Singapore, Malaysia, Costa Rica, jordan, Bermuda, Indonesia and United Kingdom","F-0380-2014","Class II","Kale, Apple & Greekstyle Yogurt Flexible pouch with Resealable spout. Packaged for individual sale in 6 count cartons and in 4 count packages. Best By dates ranging from 08/05/14 to 12/08/14 and the letters AT. DISTRIBUTED BY: NEST COLLECTIVE, INC. EMERYVILLE, CA 94608 1-877-914-PLUM WWW.NEST-COLLECTIVE.COM","UK Export only Item number KAG11U; Selling Unit UPC; 5060116891621 Case UPC:5060116897777 Best By dates ranging from 08/05/14 to 12/08/14 and the letters AT. ",".","597,827 total cases, all varieties","Manufacturing defect leading to post-process contamination.",11/8/2013,"11/08/2013",12/4/2013,"12/04/2013"
"Food",66795,"Ongoing"," Plum Inc ","Emeryville","CA","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Nationwide and to Korea, China, Mexico, Hong Kong, Singapore, Malaysia, Costa Rica, jordan, Bermuda, Indonesia and United Kingdom","F-0364-2014","Class II","Plum Organics Sweet Potato, Corn & Apple Organic Baby Food- 4 oz. Pouch Flexible pouch with Resealable spout. Packaged for individual sale in 6 count cartons and in 4 count packages. Best By dates ranging from 08/05/14 to 12/08/14 and the letters AT. DISTRIBUTED BY: NEST COLLECTIVE, INC. EMERYVILLE, CA 94608 1-877-914-PLUM WWW.NEST-COLLECTIVE.COM","Item number 11573: Selling Unit UPC; 890180001245 Case UPC: 890180001573 Item number 80013; Selling Unit UPC; 890180001245 Case UPC;846675003492 Best By dates ranging from 08/05/14 to 12/08/14 and the letters AT. ",".","597,827 total cases, all varieties.","Manufacturing defect leading to post-process contamination.",11/8/2013,"11/08/2013",12/4/2013,"12/04/2013"
"Food",66795,"Ongoing"," Plum Inc ","Emeryville","CA","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Nationwide and to Korea, China, Mexico, Hong Kong, Singapore, Malaysia, Costa Rica, jordan, Bermuda, Indonesia and United Kingdom","F-0369-2014","Class II","Plum Kids Beetbox Berry Fruit and Veggie Mashups, 12.69 oz. box. Flexible pouch with Resealable spout. Packaged for individual sale in 6 count cartons and in 4 count packages. Best By dates ranging from 08/05/14 to 12/08/14 and the letters AT. DISTRIBUTED BY: NEST COLLECTIVE, INC. EMERYVILLE, CA 94608 1-877-914-PLUM WWW.NEST-COLLECTIVE.COM","Item number 1849: Selling Unit UPC; 846675001658 Case UPC:846675001849. Best By dates ranging from 08/05/14 to 12/08/14 and the letters AT. ",".","597,827 total cases, all varieties.","Manufacturing defect leading to post-process contamination.",11/8/2013,"11/08/2013",12/4/2013,"12/04/2013"
"Food",66795,"Ongoing"," Plum Inc ","Emeryville","CA","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Nationwide and to Korea, China, Mexico, Hong Kong, Singapore, Malaysia, Costa Rica, jordan, Bermuda, Indonesia and United Kingdom","F-0377-2014","Class II","Parsnip, Blueberry & Buckwheat Flexible pouch with Resealable spout. Packaged for individual sale in 6 count cartons and in 4 count packages. Best By dates ranging from 08/05/14 to 12/08/14 and the letters AT. DISTRIBUTED BY: NEST COLLECTIVE, INC. EMERYVILLE, CA 94608 1-877-914-PLUM WWW.NEST-COLLECTIVE.COM","UK Export only Item number PBW11U; Selling Unit UPC; 5060116891676 Case UPC:5060116897821 Best By dates ranging from 08/05/14 to 12/08/14 and the letters AT. ",".","597,827 total cases, all varieties","Manufacturing defect leading to post-process contamination.",11/8/2013,"11/08/2013",12/4/2013,"12/04/2013"
"Food",66795,"Ongoing"," Plum Inc ","Emeryville","CA","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Nationwide and to Korea, China, Mexico, Hong Kong, Singapore, Malaysia, Costa Rica, jordan, Bermuda, Indonesia and United Kingdom","F-0378-2014","Class II","Plum, Strawberry Barley Flexible pouch with Resealable spout. Packaged for individual sale in 6 count cartons and in 4 count packages. Best By dates ranging from 08/05/14 to 12/08/14 and the letters AT. DISTRIBUTED BY: NEST COLLECTIVE, INC. EMERYVILLE, CA 94608 1-877-914-PLUM WWW.NEST-COLLECTIVE.COM","UK Export only Item number PBB11U; Selling Unit UPC; 5060116891638 Case UPC:5060116897784 Best By dates ranging from 08/05/14 to 12/08/14 and the letters AT. ",".","597,827 total cases, all varieties","Manufacturing defect leading to post-process contamination.",11/8/2013,"11/08/2013",12/4/2013,"12/04/2013"
"Food",66795,"Ongoing"," Plum Inc ","Emeryville","CA","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Nationwide and to Korea, China, Mexico, Hong Kong, Singapore, Malaysia, Costa Rica, jordan, Bermuda, Indonesia and United Kingdom","F-0366-2014","Class II","Plum Organics Pumpkin & Banana Organic Baby Food, 3.5 oz. pouch.. Flexible pouch with Resealable spout. Packaged for individual sale in 6 count cartons and in 4 count packages. Best By dates ranging from 08/05/14 to 12/08/14 and the letters AT. DISTRIBUTED BY: NEST COLLECTIVE, INC. EMERYVILLE, CA 94608 1-877-914-PLUM WWW.NEST-COLLECTIVE.COM","Item number 1597: Selling Unit UPC:890180001238; Case UPC: 890180001597; Item number: 80017: Selling Unit UPC: 890180001238 Case UPC: 846675003959 Best By dates ranging from 08/05/14 to 12/08/14 and the letters AT. ",".","597,827 total cases, all varieties","Manufacturing defect leading to post-process contamination.",11/8/2013,"11/08/2013",12/4/2013,"12/04/2013"
"Food",66795,"Ongoing"," Plum Inc ","Emeryville","CA","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Nationwide and to Korea, China, Mexico, Hong Kong, Singapore, Malaysia, Costa Rica, jordan, Bermuda, Indonesia and United Kingdom","F-0355-2014","Class II","Plum Organics Zucchini, Banana & Amaranth Organic Baby Food; 3.5 oz. Pouch; Flexible pouch with Resealable spout. Packaged for individual sale in 6 count cartons and in 4 count packages. Best By dates ranging from 08/05/14 to 12/08/14 and the letters AT. DISTRIBUTED BY: NEST COLLECTIVE, INC. EMERYVILLE, CA 94608 1-877-914-PLUM WWW.NEST-COLLECTIVE.COM","Item number 1238: Selling Unit UPC: 846675001061; Case UPC: 846675001238 Item number 80021; Selling Unit UPC: 846675001061; Case UPC: 846675003966 Best By dates ranging from 08/05/14 to 12/08/14 and the letters AT. ",".","597,827 cases, total all varieties.","Manufacturing defect leading to post-process contamination.",11/8/2013,"11/08/2013",12/4/2013,"12/04/2013"
"Food",66795,"Ongoing"," Plum Inc ","Emeryville","CA","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Nationwide and to Korea, China, Mexico, Hong Kong, Singapore, Malaysia, Costa Rica, jordan, Bermuda, Indonesia and United Kingdom","F-0356-2014","Class II","Plum Organics Plum, Berry & Barley Organic Baby Food; 3.5 oz. Pouch; Flexible pouch with Resealable spout. Packaged for individual sale in 6 count cartons and in 4 count packages. Best By dates ranging from 08/05/14 to 12/08/14 and the letters AT. DISTRIBUTED BY: NEST COLLECTIVE, INC. EMERYVILLE, CA 94608 1-877-914-PLUM WWW.NEST-COLLECTIVE.COM","Item number 1245: Selling Unit UPC: 846675001078 ; Case UPC: 846675001245 Item number: 80019; Selling Unit UPC: 846675001078 ; Case UPC: 846675003980 Best By dates ranging from 08/05/14 to 12/08/14 and the letters AT. ",".","597,827 cases total, all varieties.","Manufacturing defect leading to post-process contamination.",11/8/2013,"11/08/2013",12/4/2013,"12/04/2013"
"Food",66795,"Ongoing"," Plum Inc ","Emeryville","CA","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Nationwide and to Korea, China, Mexico, Hong Kong, Singapore, Malaysia, Costa Rica, jordan, Bermuda, Indonesia and United Kingdom","F-0375-2014","Class II","Plum Organics Kale, Apple & Greek Yogurt Organics Baby Food- 3.5 oz. Pouch Flexible pouch with Resealable spout. Packaged for individual sale in 6 count cartons and in 4 count packages. Best By dates ranging from 08/05/14 to 12/08/14 and the letters AT. DISTRIBUTED BY: NEST COLLECTIVE, INC. EMERYVILLE, CA 94608 1-877-914-PLUM WWW.NEST-COLLECTIVE.COM","Item number 80008: Selling Unit UPC; 846675003768 Case UPC:00846675003843 Best By dates ranging from 08/05/14 to 12/08/14 and the letters AT. ",".","597,827 total cases, all varieties.","Manufacturing defect leading to post-process contamination.",11/8/2013,"11/08/2013",12/4/2013,"12/04/2013"
"Biologics",66796,"Terminated","Ortho Clinical Diagnostics Inc","Raritan","NJ","US","Voluntary: Firm Initiated","Letter","Multiple U.S. States","B-0146-14","Class II","Blood Grouping Reagent, Anti-s","LS164A",,"1 vial","IVD with weakened reactivity was distributed.",10/11/2013,"10/11/2013",12/18/2013,"12/18/2013"
"Biologics",66798,"Terminated","American National Red Cross The","Pomona","CA","US","Voluntary: Firm Initiated","FAX","California","B-0149-14","Class III","Red Blood Cells (Apheresis) Leukocytes Reduced","W200613057845, W200613038754, W200613068033, W200613055708, W200613057827, W200613057827, W200613038772, W200613078697, W200613060649, W200613060649, W200613056897, W200613068040, W200613068040, W200613046263, W200613065134, W200613060690, W200613068031, W200613060680, W200613060680, W200613077476, W200613060658, W200613060648, W200613060681, W200613060681, W200613080591, W200613062914, W200613080603, W200613080614, W200613080633, W200613080635",,"30 units","Red Blood Cells, with discrepant labeled volumes, were distributed. ",8/29/2013,"08/29/2013",12/18/2013,"12/18/2013"
"Drugs",66807,"Ongoing","Apotex Inc.","Toronto",,"CA","Voluntary: Firm Initiated","Letter","Nationwide and Puerto Rico","D-017-2014","Class II","Acyclovir Tablets USP 800 mg ,(NDC 60505-5307-1), Rx only, Manufactured by Apotex Inc., Toronto, Ontario, Canada M9L 1T9, Manufactured for Apotex Corp.,Weston, Florida 33326.","Lot # KF2199 Exp 07/15",".","4,844 bottles ","Presence of Particulate Matter: Product from lot KF2199, may contain tablets with pieces of nitrile rubber glove embedded within the tablets.",7/17/2013,"07/17/2013",12/4/2013,"12/04/2013"
"Devices",66808,"Ongoing","Iba Dosimetry Gmbh","Schwarzenbruck",,"DE","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Worldwide Distribution - US Distribution including the states of CT, MA, OH, CA, SC, NY and OK, and the countries of International distribution (from Germany) Poland, Germany, GB, The Netherlands, Spain, Turkey, Canada, Mexico, China, Hong Kong and Singapore.","Z-0456-2014","Class II","iba COMPASS SW Version 3.0, Catalog Number CS10-100 (medical linear accelerator) radiological","SW Version 3.0. Catalong Number CS10-100",,"33 units","The development partner of IBA informed that there is problem in a SW component used in COMPASS when converting Region of Interest (ROI) geometries to dose grid representation. Under certain conditions this problem generates too large ROI voxel volumes causing erroneous dose statistics and DVHs. ",8/20/2013,"08/20/2013",12/18/2013,"12/18/2013"
"Devices",66809,"Ongoing","Zimmer, Inc.","Warsaw","IN","US","Voluntary: Firm Initiated","E-Mail","Worldwide Distribution - USA (nationwide) and Internationally to Australia, Belgium, Canada, Denmark, Ecuador, Germany, India, Italy, Japan, Korea, Malaysia, Mexico, Netherlands, Peru, Singapore, South Africa, Spain, Switzerland, UAE, and UK.","Z-0459-2014","Class II","NexGen Complete Knee Solution Porous Patella Drill Guide-26mm dia./10mm thickness Non sterile, Rx Only Devices are used in total knee arthroplasty and indicated for patients with severe pain and disability due to conditions such as arthritis, collagen disorders, post-traumatic loss of joint configuration, flexion deformities, and in revision of previous surgical attempts.","Part Number 00-5879-067-26",,"625 units","This is an expansion of the June 2013 recall related to NexGen Micro components due to a component compatibility issue. Since the initiation of this recall, five (5) additional instruments have been identified that are associated only with the NexGen Micro components. Given this, all lots of these additional instruments are now being recalled as well. There is the potential for these devices to be inadvertently utilized during surgery and the associated implanted would not be available due to the previous recall. ",11/19/2013,"11/19/2013",12/18/2013,"12/18/2013"
"Devices",66809,"Ongoing","Zimmer, Inc.","Warsaw","IN","US","Voluntary: Firm Initiated","E-Mail","Worldwide Distribution - USA (nationwide) and Internationally to Australia, Belgium, Canada, Denmark, Ecuador, Germany, India, Italy, Japan, Korea, Malaysia, Mexico, Netherlands, Peru, Singapore, South Africa, Spain, Switzerland, UAE, and UK.","Z-0460-2014","Class II","NexGen Complete Knee Solution Porous Patella Drill Guide-29mm dia./10mm thickness Non sterile, Rx Only Devices are used in total knee arthroplasty and indicated for patients with severe pain and disability due to conditions such as arthritis, collagen disorders, post-traumatic loss of joint configuration, flexion deformities, and in revision of previous surgical attempts.","Part Number 00-5879-067-29",,"641 units","This is an expansion of the June 2013 recall related to NexGen Micro components due to a component compatibility issue. Since the initiation of this recall, five (5) additional instruments have been identified that are associated only with the NexGen Micro components. Given this, all lots of these additional instruments are now being recalled as well. There is the potential for these devices to be inadvertently utilized during surgery and the associated implanted would not be available due to the previous recall. ",11/19/2013,"11/19/2013",12/18/2013,"12/18/2013"
"Devices",66809,"Ongoing","Zimmer, Inc.","Warsaw","IN","US","Voluntary: Firm Initiated","E-Mail","Worldwide Distribution - USA (nationwide) and Internationally to Australia, Belgium, Canada, Denmark, Ecuador, Germany, India, Italy, Japan, Korea, Malaysia, Mexico, Netherlands, Peru, Singapore, South Africa, Spain, Switzerland, UAE, and UK.","Z-0461-2014","Class II","NexGen Complete Knee Solution CR Articular Surface Provisional-Purple 9mm Height Nonsterile Devices are used in total knee arthroplasty and indicated for patients with severe pain and disability due to conditions such as arthritis, collagen disorders, post-traumatic loss of joint configuration, flexion deformities, and in revision of previous surgical attempts.","Part Number 00-5971-020-09",,"638 units","This is an expansion of the June 2013 recall related to NexGen Micro components due to a component compatibility issue. Since the initiation of this recall, five (5) additional instruments have been identified that are associated only with the NexGen Micro components. Given this, all lots of these additional instruments are now being recalled as well. There is the potential for these devices to be inadvertently utilized during surgery and the associated implanted would not be available due to the previous recall. ",11/19/2013,"11/19/2013",12/18/2013,"12/18/2013"
"Devices",66809,"Ongoing","Zimmer, Inc.","Warsaw","IN","US","Voluntary: Firm Initiated","E-Mail","Worldwide Distribution - USA (nationwide) and Internationally to Australia, Belgium, Canada, Denmark, Ecuador, Germany, India, Italy, Japan, Korea, Malaysia, Mexico, Netherlands, Peru, Singapore, South Africa, Spain, Switzerland, UAE, and UK.","Z-0463-2014","Class II","NexGen Complete Knee Solution CR Articular Surface Provisional-Striped Green 9mm Height Nonsterile Devices are used in total knee arthroplasty and indicated for patients with severe pain and disability due to conditions such as arthritis, collagen disorders, post-traumatic loss of joint configuration, flexion deformities, and in revision of previous surgical attempts.","Part Number 00-5971-041-09",,"439 units","This is an expansion of the June 2013 recall related to NexGen Micro components due to a component compatibility issue. Since the initiation of this recall, five (5) additional instruments have been identified that are associated only with the NexGen Micro components. Given this, all lots of these additional instruments are now being recalled as well. There is the potential for these devices to be inadvertently utilized during surgery and the associated implanted would not be available due to the previous recall. ",11/19/2013,"11/19/2013",12/18/2013,"12/18/2013"
"Devices",66809,"Ongoing","Zimmer, Inc.","Warsaw","IN","US","Voluntary: Firm Initiated","E-Mail","Worldwide Distribution - USA (nationwide) and Internationally to Australia, Belgium, Canada, Denmark, Ecuador, Germany, India, Italy, Japan, Korea, Malaysia, Mexico, Netherlands, Peru, Singapore, South Africa, Spain, Switzerland, UAE, and UK.","Z-0462-2014","Class II","NexGen Complete Knee Solution CR Articular Surface Provisional-Yellow 9mm Height Nonsterile Devices are used in total knee arthroplasty and indicated for patients with severe pain and disability due to conditions such as arthritis, collagen disorders, post-traumatic loss of joint configuration, flexion deformities, and in revision of previous surgical attempts.","Part Number 00-5971-031-09",,"684 units","This is an expansion of the June 2013 recall related to NexGen Micro components due to a component compatibility issue. Since the initiation of this recall, five (5) additional instruments have been identified that are associated only with the NexGen Micro components. Given this, all lots of these additional instruments are now being recalled as well. There is the potential for these devices to be inadvertently utilized during surgery and the associated implanted would not be available due to the previous recall. ",11/19/2013,"11/19/2013",12/18/2013,"12/18/2013"
"Drugs",66810,"Ongoing","Fresenius Kabi USA, LLC","Lake Zurich","IL","US","Voluntary: Firm Initiated","Letter","US: Nationwide and Puerto Rico","D-016-2014","Class III","PACLITAXEL INJECTION, USP (semisynthetic); 300 mg/50 mL; (6 mg/mL); Multiple Dose Vial;(NDC 63323-763-50); Rx Only; Manufactured for APP Pharmaceuticals, LLC; Schaumburg, IL 60173; Made in India","Lot # 871ZA00201, Exp 11/13 Lot # 871ZA00301, Exp 11/13 Lot # 871ZA00302, Exp 11/13 Lot # 871ZA00401, Exp 11/13 Lot # 871ZA00402, Exp 11/13 Lot # 872ZA00101, Exp 12/13 Lot # 872ZA00201, Exp 12/13 Lot # 872ZA00301, Exp 12/13 Lot # 872ZA00401, Exp 12/13 Lot # 872ZA00501, Exp 12/13",".","71,129 vials","Labeling: Incorrect or Missing Package Insert- Missing text on the product insert in the ''Clinical Studies'' and ''Specific Adverse Events'' sections.",11/8/2013,"11/08/2013",12/4/2013,"12/04/2013"
"Food",66812,"Completed","Palmer Candy Co","Sioux City","IA","US","Voluntary: Firm Initiated","Telephone","Distribution was made to a distribution center in Iowa.","F-0732-2014","Class I","HyVee Chocolate Covered Caramels, packaged in 12-oz. clear plastic clamshell containers (UPC 077232125207), 16 containers/case (UPC 10077232125204). The firm name on the label is HyVee, West Des Moines, IA.","Sell by 10/07/14 F30202",,"99/16/12-oz. container cases","Chocolate caramel clusters containing peanuts were mislabeled as chocolate covered caramels, which do not contain peanuts.",11/8/2013,"11/08/2013",12/18/2013,"12/18/2013"
"Food",66812,"Completed","Palmer Candy Co","Sioux City","IA","US","Voluntary: Firm Initiated","Telephone","Distribution was made to a distribution center in Iowa.","F-0731-2014","Class I","HyVee Chocolate Caramel Clusters, packaged in 9-oz. clear plastic clamshell containers (UPC 077232125153), 16 containers/case (UPC 10077232125150). The firm name on the label is HyVee, West Des Moines, IA.","Sell by 04/07/14 F30202",,"159/16/9-oz. container cases","Chocolate caramel clusters containing peanuts were mislabeled as chocolate covered caramels, which do not contain peanuts.",11/8/2013,"11/08/2013",12/18/2013,"12/18/2013"
"Devices",66815,"Ongoing","Advanced Sterilization Products","Irvine","CA","US","Voluntary: Firm Initiated","Letter","Nationwide Distribution","Z-0402-2014","Class II","STERRAD 100NX, Product Code: 10104 The STERRAD Steri lization System is a low temperature general purpose sterilizer used to sterilize heat and moisture sensitive reusable medical devices.","Please refer to consignee list",".","Total 4,381 units","Advanced Sterilization Products (ASP) is recalling the STERRAD NX and STERRAD 100NX sterilization systems because ASP has determined that the bronchoscopes may contain a polyurethane material in the suction channel location that is not listed in the current claims for interior channels (lumens) for processing in STERRAD systems.",11/11/2013,"11/11/2013",12/4/2013,"12/04/2013"
"Devices",66815,"Ongoing","Advanced Sterilization Products","Irvine","CA","US","Voluntary: Firm Initiated","Letter","Nationwide Distribution","Z-0403-2014","Class II","STERRAD NX, Product Code: 10033 The STERRAD Steri lization System is a low temperature general purpose sterilizer used to sterilize heat and moisture sensitive reusable medical devices.","Please refer to consignee list",".","Total 4,381 units","Advanced Sterilization Products (ASP) is recalling the STERRAD NX and STERRAD 100NX sterilization systems because ASP has determined that the bronchoscopes may contain a polyurethane material in the suction channel location that is not listed in the current claims for interior channels (lumens) for processing in STERRAD systems.",11/11/2013,"11/11/2013",12/4/2013,"12/04/2013"
"Biologics",66818,"Ongoing","HCSC-Blood Center","Bethlehem","PA","US","Voluntary: Firm Initiated","Telephone","MD, NJ","B-0148-14","Class III","Pooled cryoprecipitated AHF","W050912103012, W050912103013, W050912078263, W050912078284, W050912040349, W050912040351, W050912078217, W050912078218, W050912078251, W050912078255, W050912078262, W050913004147, W050913004185, W050913019516, W050913029016, W050912040352, W050912078212, W050912078214, W050912078219, W050912013984, W050912013986, W050912013987, W050912013989, W050912078256, W050912078257, W050912078260, W050912078261, W050912040374, W050912040380, W050912040398, W050913004149, W050913004150, W050913004154, W050912103019, W050913004128, W050913019528, W050913019529, W050913041907, W050913041928, W050913041935, W050913041949, W050913041931, W050913041970, W050913047912, W050913047916, W050913055388, W050913055389, W050913055392, W050913047964, W050913047967, W050913047971, W050913047973",,"52 units","Unlicensed blood products were distributed in interstate commerce. ",9/20/2013,"09/20/2013",12/18/2013,"12/18/2013"
"Food",66819,"Ongoing","Garden-Fresh Foods, Inc.","Milwaukee","WI","US","Voluntary: Firm Initiated","Press Release","IL, IN, MI, MN, MO, OH, PA, WI.","F-0992-2014","Class I","Garden-Fresh, Onions Diced 1/4'', 4/5 lb., 0 11596 50301 2, 11/1/2013 - 11/4/2013; Garden-Fresh, Onions Diced 1/4'', 1/5 lb., 0 11596 50302 8, 11/11/2013; Garden-Fresh, Onions Diced 1/4'', 1/2.5 lb., 0 11596 50304 2, 10/31/2013; Garden-Fresh, Onions Diced 1/4'', 2/5 lb., 0 11596 50306 6 , 11/9/2013; Garden-Fresh Onions Diced 3/8'', 1/5 lb., 0 11596 50305 9, 10/30/2013 - 11/6/2013; Garden-Fresh, Onions Diced 3/8'', 2/5 lb., 0 11596 50329 5, 10/30/2013 - 11/6/2013; Garden-Fresh, Onions Julienne Cut, 2/2.5 lb., 0 11596 50321 9, 11/6/2013 - 11/11/2013; Garden-Fresh, Onions Julienne Cut, 2/5 lb., 0 11596 50340 0, 10/29/2013 - 11/1/2013; Garden-Fresh, Onions Sliced 1/4'', 2/5 lb., 0 11596 50314 , 10/29/2013; Garden-Fresh, Onions Sliced 3/16'', 1/5 lb., 0 11596 50310 5 , 11/10/2013; Garden-Fresh, Onions Sliced 3/16'', 2/5 lb., 0 11596 50311 0, 10/31/2013 - 11/1/2013; Garden-Fresh, Onions Slivered, 1/5 lb., 0 11596 50315 8, 10/30/2013 - 11/6/2013; ;","0 11596 50301 2 11/1/2013 - 11/4/2013; 0 11596 50302 8 11/11/2013; 0 11596 50304 2 10/31/2013; 0 11596 50306 6 11/9/2013; 0 11596 50305 9 10/30/2013 - 11/6/2013; 0 11596 50329 5 10/30/2013 - 11/6/2013; 0 11596 50321 9 11/6/2013 - 11/11/2013; 0 11596 50340 0 10/29/2013 - 11/1/2013; 0 11596 50314 10/29/2013; 0 11596 50310 5 11/10/2013; 0 11596 50311 0 10/31/2013 - 11/1/2013; 0 11596 50315 8 10/30/2013 - 11/6/2013; ","."," 919,616.31 total pounds, for all products","Garden-Fresh Foods is recalling various cut vegetables, ready-to-eat salads, slaw, spread and dip products sold under various brands and code dates manufactured prior to November 06, 2013 because they may be contaminated with Listeria monocytogenes.",11/7/2013,"11/07/2013",12/26/2013,"12/26/2013"
"Food",66819,"Ongoing","Garden-Fresh Foods, Inc.","Milwaukee","WI","US","Voluntary: Firm Initiated","Press Release","IL, IN, MI, MN, MO, OH, PA, WI.","F-0983-2014","Class I","Dairy Fresh Macaroni Salad, 2/5 lb., 0 70163 56415 2, 12/5/2013 Family Style Macaroni Salad, 2/5 lb., 0 11596 52060 5, 0 00 11596 52060 5, 11/22/2013 - 12/7/2013 Finest Traditions, Macaroni Salad, 1/8 lb., 10 733147 10286 9, 11/18/2013 - 12/4/2013, Finest Traditions, Macaroni Salad, 6/16 oz., 7 33147 00018 2 10 733147 10157 2, 11/25/2013 - 11/25/2013 Garden-Fresh, Macaroni Salad, 2/5 lb., 0 11596 52005 6, 11/21/2013 - 12/7/2013 Garden-Fresh, Macaroni Salad, 12/16 oz., 0 11596 14018 6, 0 11596 14018 6, 11/25/2013 - 12/5/2013 Garden-Fresh, Macaroni Salad, 8/32 oz., 0 11596 24210 1, 0 11596 24210 1, 11/22/2013 - 12/7/2013 Garden-Fresh Macaroni Salad 6/48 oz. 0 11596 34305 1 0 11596 34305 1 11/22/2013 - 12/6/2013 Grandpa's, Macaroni Salad, 12/16 oz., 0 11596 14066 7, 0 11596 24066 4, 11/25/2013 Rogge's, Macaroni Salad, 2/5 lb., 0 11596 52019 3, 11/11/2013 Spartan, Macaroni Salad, 6/16 oz., 0 11213 90321 7, 0 00 11213 90321 7, 11/25/2013 - 12/2/2013 "," 0 70163 56415 2 12/5/2013; 0 11596 52060 5 0 00 11596 52060 5 11/22/2013 - 12/7/2013; 10 733147 10286 9 11/18/2013 - 12/4/2013; 7 33147 00018 2 10 733147 10157 2 11/25/2013 - 11/25/2013; 0 11596 52005 6 11/21/2013 - 12/7/2013; 0 11596 14018 6 0 11596 14018 6 11/25/2013 - 12/5/2013; 0 11596 24210 1 0 11596 24210 1 11/22/2013 - 12/7/2013; 0 11596 34305 1 0 11596 34305 1 11/22/2013 - 12/6/2013; 0 11596 14066 7 0 11596 24066 4 11/25/2013; 0 11596 52019 3 11/11/2013; 0 11213 90321 7 0 00 11213 90321 7 11/25/2013 - 12/2/2013;","."," 919,616.31 total pounds, for all products","Garden-Fresh Foods is recalling various cut vegetables, ready-to-eat salads, slaw, spread and dip products sold under various brands and code dates manufactured prior to November 06, 2013 because they may be contaminated with Listeria monocytogenes.",11/7/2013,"11/07/2013",12/26/2013,"12/26/2013"
"Food",66819,"Ongoing","Garden-Fresh Foods, Inc.","Milwaukee","WI","US","Voluntary: Firm Initiated","Press Release","IL, IN, MI, MN, MO, OH, PA, WI.","F-1017-2014","Class I","Garden-Fresh, Quinoa Natural Energy Salad, 1/8 lb., 0 11596 82074 3, 12/2/2013; ","0 11596 82074 3, 12/2/2013; ","."," 919,616.31 total pounds, for all products","Garden-Fresh Foods is recalling various cut vegetables, ready-to-eat salads, slaw, spread and dip products sold under various brands and code dates manufactured prior to November 06, 2013 because they may be contaminated with Listeria monocytogenes.",11/7/2013,"11/07/2013",12/26/2013,"12/26/2013"
"Food",66819,"Ongoing","Garden-Fresh Foods, Inc.","Milwaukee","WI","US","Voluntary: Firm Initiated","Press Release","IL, IN, MI, MN, MO, OH, PA, WI.","F-0970-2014","Class I","Our Own, Homestyle Mustard Potato Salad, 4/5 lb., 0 11596 51047 7, 0 00 11596 51047 7, 11/16/2013 - 12/5/2013; ","0 11596 51047 7, 0 00 11596 51047 7, 11/16/2013 - 12/5/2013; ","."," 919,616.31 total pounds, for all products","Garden-Fresh Foods is recalling various cut vegetables, ready-to-eat salads, slaw, spread and dip products sold under various brands and code dates manufactured prior to November 06, 2013 because they may be contaminated with Listeria monocytogenes.",11/7/2013,"11/07/2013",12/26/2013,"12/26/2013"
"Food",66819,"Ongoing","Garden-Fresh Foods, Inc.","Milwaukee","WI","US","Voluntary: Firm Initiated","Press Release","IL, IN, MI, MN, MO, OH, PA, WI.","F-0867-2014","Class I","Weis, Baked Lima Beans, 1/5 lb., 0 11596 52111 4, 11/21/2013 - 12/3/2013 ","0 11596 52111 4, 11/21/2013 - 12/3/2013 ","."," 919,616.31 total pounds, for all products","Garden-Fresh Foods is recalling various cut vegetables, ready-to-eat salads, slaw, spread and dip products sold under various brands and code dates manufactured prior to November 06, 2013 because they may be contaminated with Listeria monocytogenes.",11/7/2013,"11/07/2013",12/26/2013,"12/26/2013"
"Food",66819,"Ongoing","Garden-Fresh Foods, Inc.","Milwaukee","WI","US","Voluntary: Firm Initiated","Press Release","IL, IN, MI, MN, MO, OH, PA, WI.","F-1057-2014","Class I","Finest Traditions, Spinach Pasta Salad Base, 1/5 lb., 10 733147 10978 3, 11/25/2013 - 12/9/2013 ","10 733147 10978 3, 11/25/2013 - 12/9/2013 ","."," 919,616.31 total pounds, for all products","Garden-Fresh Foods is recalling various cut vegetables, ready-to-eat salads, slaw, spread and dip products sold under various brands and code dates manufactured prior to November 06, 2013 because they may be contaminated with Listeria monocytogenes.",11/7/2013,"11/07/2013",12/26/2013,"12/26/2013"
"Food",66819,"Ongoing","Garden-Fresh Foods, Inc.","Milwaukee","WI","US","Voluntary: Firm Initiated","Press Release","IL, IN, MI, MN, MO, OH, PA, WI.","F-0936-2014","Class I","Garden-Fresh Fantastic Seafood Salad Kit 2/5 lb. 0 11596 95104 1 11/12/2013 - 11/19/2013 ","0 11596 95104 1 11/12/2013 - 11/19/2013 ","."," 919,616.31 total pounds, for all products","Garden-Fresh Foods is recalling various cut vegetables, ready-to-eat salads, slaw, spread and dip products sold under various brands and code dates manufactured prior to November 06, 2013 because they may be contaminated with Listeria monocytogenes.",11/7/2013,"11/07/2013",12/26/2013,"12/26/2013"
"Food",66819,"Ongoing","Garden-Fresh Foods, Inc.","Milwaukee","WI","US","Voluntary: Firm Initiated","Press Release","IL, IN, MI, MN, MO, OH, PA, WI.","F-0875-2014","Class I","Garden-Fresh, Bow Tie Salad Kit, 1/5 lb.,0 11596 50179 6, 11/9/2013 - 11/14/2013 ","0 11596 50179 6, 11/9/2013 - 11/14/2013 ","."," 919,616.31 total pounds, for all products","Garden-Fresh Foods is recalling various cut vegetables, ready-to-eat salads, slaw, spread and dip products sold under various brands and code dates manufactured prior to November 06, 2013 because they may be contaminated with Listeria monocytogenes.",11/7/2013,"11/07/2013",12/26/2013,"12/26/2013"
"Food",66819,"Ongoing","Garden-Fresh Foods, Inc.","Milwaukee","WI","US","Voluntary: Firm Initiated","Press Release","IL, IN, MI, MN, MO, OH, PA, WI.","F-0921-2014","Class I","Finest Traditions, Creamy Fruit Salad, 1/8 lb., 10 733147 10101 5, 11/6/2013 - 11/25/2013 ","10 733147 10101 5, 11/6/2013 - 11/25/2013 ","."," 919,616.31 total pounds, for all products","Garden-Fresh Foods is recalling various cut vegetables, ready-to-eat salads, slaw, spread and dip products sold under various brands and code dates manufactured prior to November 06, 2013 because they may be contaminated with Listeria monocytogenes.",11/7/2013,"11/07/2013",12/26/2013,"12/26/2013"
"Food",66819,"Ongoing","Garden-Fresh Foods, Inc.","Milwaukee","WI","US","Voluntary: Firm Initiated","Press Release","IL, IN, MI, MN, MO, OH, PA, WI.","F-1037-2014","Class I","Spoon River, Seafood Salad Kit, 1/5.5 lb., 0 11596 55106, 11/21/2013 - 12/10/2013; ","0 11596 55106, 11/21/2013 - 12/10/2013; ","."," 919,616.31 total pounds, for all products","Garden-Fresh Foods is recalling various cut vegetables, ready-to-eat salads, slaw, spread and dip products sold under various brands and code dates manufactured prior to November 06, 2013 because they may be contaminated with Listeria monocytogenes.",11/7/2013,"11/07/2013",12/26/2013,"12/26/2013"
"Food",66819,"Ongoing","Garden-Fresh Foods, Inc.","Milwaukee","WI","US","Voluntary: Firm Initiated","Press Release","IL, IN, MI, MN, MO, OH, PA, WI.","F-0946-2014","Class II","Farmer's Market, Fresh Salsa Jalapeno Mild, 6/15 oz., 0 11596 06142 9, 0 00 11596 06142 9, 12/14/2013 - 12/15/2013 ;","0 11596 06142 9, 0 00 11596 06142 9, 12/14/2013 - 12/15/2013 ","."," 919,616.31 total pounds, for all products","Garden-Fresh Foods is recalling various cut vegetables, ready-to-eat salads, slaw, spread and dip products sold under various brands and code dates manufactured prior to November 06, 2013 because they may be contaminated with Listeria monocytogenes.",11/7/2013,"11/07/2013",12/26/2013,"12/26/2013"
"Food",66819,"Ongoing","Garden-Fresh Foods, Inc.","Milwaukee","WI","US","Voluntary: Firm Initiated","Press Release","IL, IN, MI, MN, MO, OH, PA, WI.","F-0999-2014","Class I","Finest Traditions, Pea & Cheese Pasta Salad, 1/8 lb., 10 733147 10146 6, 11/25/2013 - 12/9/2013; ","10 733147 10146 6, 11/25/2013 - 12/9/2013; ","."," 919,616.31 total pounds, for all products","Garden-Fresh Foods is recalling various cut vegetables, ready-to-eat salads, slaw, spread and dip products sold under various brands and code dates manufactured prior to November 06, 2013 because they may be contaminated with Listeria monocytogenes.",11/7/2013,"11/07/2013",12/26/2013,"12/26/2013"
"Food",66819,"Ongoing","Garden-Fresh Foods, Inc.","Milwaukee","WI","US","Voluntary: Firm Initiated","Press Release","IL, IN, MI, MN, MO, OH, PA, WI.","F-0943-2014","Class II","Grandpa's, Fresh Mango Salsa, 1/5 lb., 0 11596 55916 2, 12/9/2013 - 12/12/2013 ","0 11596 55916 2 12/9/2013 - 12/12/2013 ","."," 919,616.31 total pounds, for all products","Garden-Fresh Foods is recalling various cut vegetables, ready-to-eat salads, slaw, spread and dip products sold under various brands and code dates manufactured prior to November 06, 2013 because they may be contaminated with Listeria monocytogenes.",11/7/2013,"11/07/2013",12/26/2013,"12/26/2013"
"Food",66819,"Ongoing","Garden-Fresh Foods, Inc.","Milwaukee","WI","US","Voluntary: Firm Initiated","Press Release","IL, IN, MI, MN, MO, OH, PA, WI.","F-0909-2014","Class I","Finest Traditions, Cookies & Creme Dessert, 1/8 lb., 10 733147 00022 6, 11/11/2013 - 11/25/2013 ","10 733147 00022 6, 11/11/2013 - 11/25/2013 ","."," 919,616.31 total pounds, for all products","Garden-Fresh Foods is recalling various cut vegetables, ready-to-eat salads, slaw, spread and dip products sold under various brands and code dates manufactured prior to November 06, 2013 because they may be contaminated with Listeria monocytogenes.",11/7/2013,"11/07/2013",12/26/2013,"12/26/2013"
"Food",66819,"Ongoing","Garden-Fresh Foods, Inc.","Milwaukee","WI","US","Voluntary: Firm Initiated","Press Release","IL, IN, MI, MN, MO, OH, PA, WI.","F-0917-2014","Class I","Garden-Fresh, Cranberry Walnut Red Cabbage Slaw,1/8.25 lb., 0 11596 83028 5, 11/18/2013 - 12/6/2013 ","0 11596 83028 5, 11/18/2013 - 12/6/2013 ","."," 919,616.31 total pounds, for all products","Garden-Fresh Foods is recalling various cut vegetables, ready-to-eat salads, slaw, spread and dip products sold under various brands and code dates manufactured prior to November 06, 2013 because they may be contaminated with Listeria monocytogenes.",11/7/2013,"11/07/2013",12/26/2013,"12/26/2013"
"Food",66819,"Ongoing","Garden-Fresh Foods, Inc.","Milwaukee","WI","US","Voluntary: Firm Initiated","Press Release","IL, IN, MI, MN, MO, OH, PA, WI.","F-1089-2014","Class I","Spoon River, Western Veggie Dip, 1/5 lb., 0 11596 55679 6, 12/16/2013 - 12/30/2013; ","0 11596 55679 6, 12/16/2013 - 12/30/2013; ","."," 919,616.31 total pounds, for all products","Garden-Fresh Foods is recalling various cut vegetables, ready-to-eat salads, slaw, spread and dip products sold under various brands and code dates manufactured prior to November 06, 2013 because they may be contaminated with Listeria monocytogenes.",11/7/2013,"11/07/2013",12/26/2013,"12/26/2013"
"Food",66819,"Ongoing","Garden-Fresh Foods, Inc.","Milwaukee","WI","US","Voluntary: Firm Initiated","Press Release","IL, IN, MI, MN, MO, OH, PA, WI.","F-0890-2014","Class I","Garden-Fresh, Caprese Pasta Salad Kit, 1/5 lb., 0 11 11596 52701 3, 11/11/2013 - 11/26/2013 ","0 11 11596 52701 3, 11/11/2013 - 11/26/2013 ","."," 919,616.31 total pounds, for all products","Garden-Fresh Foods is recalling various cut vegetables, ready-to-eat salads, slaw, spread and dip products sold under various brands and code dates manufactured prior to November 06, 2013 because they may be contaminated with Listeria monocytogenes.",11/7/2013,"11/07/2013",12/26/2013,"12/26/2013"
"Food",66819,"Ongoing","Garden-Fresh Foods, Inc.","Milwaukee","WI","US","Voluntary: Firm Initiated","Press Release","IL, IN, MI, MN, MO, OH, PA, WI.","F-0914-2014","Class I","Garden-Fresh, Cranberry Apple Relish, 1/5 lb., 0 11596 17092 3, 12/16/2013 ","0 11596 17092 3, 12/16/2013 ","."," 919,616.31 total pounds, for all products","Garden-Fresh Foods is recalling various cut vegetables, ready-to-eat salads, slaw, spread and dip products sold under various brands and code dates manufactured prior to November 06, 2013 because they may be contaminated with Listeria monocytogenes.",11/7/2013,"11/07/2013",12/26/2013,"12/26/2013"
"Food",66819,"Ongoing","Garden-Fresh Foods, Inc.","Milwaukee","WI","US","Voluntary: Firm Initiated","Press Release","IL, IN, MI, MN, MO, OH, PA, WI.","F-0896-2014","Class I","Our Own, Cheesecake Delight, 1/8 lb., 0 11596 85066 5 11/21/2013 - 12/9/2013 ","0 11596 85066 5 11/21/2013 - 12/9/2013 ","."," 919,616.31 total pounds, for all products","Garden-Fresh Foods is recalling various cut vegetables, ready-to-eat salads, slaw, spread and dip products sold under various brands and code dates manufactured prior to November 06, 2013 because they may be contaminated with Listeria monocytogenes.",11/7/2013,"11/07/2013",12/26/2013,"12/26/2013"
"Food",66819,"Ongoing","Garden-Fresh Foods, Inc.","Milwaukee","WI","US","Voluntary: Firm Initiated","Press Release","IL, IN, MI, MN, MO, OH, PA, WI.","F-1097-2014","Class I","Finest Traditions, Wild Rice Salad Base, 1/8 lb., 10 733147 10182 4, 11/25/2013 - 12/9/2013; ","10 733147 10182 4, 11/25/2013 - 12/9/2013; ","."," 919,616.31 total pounds, for all products","Garden-Fresh Foods is recalling various cut vegetables, ready-to-eat salads, slaw, spread and dip products sold under various brands and code dates manufactured prior to November 06, 2013 because they may be contaminated with Listeria monocytogenes.",11/7/2013,"11/07/2013",12/26/2013,"12/26/2013"
"Food",66819,"Ongoing","Garden-Fresh Foods, Inc.","Milwaukee","WI","US","Voluntary: Firm Initiated","Press Release","IL, IN, MI, MN, MO, OH, PA, WI.","F-0955-2014","Class I","Garden-Fresh, Genoa Chopped Salad Kit, 1/7.95 lb. ,0 11596 73037 0 11/9/2013 - 11/12/2013 ","0 11596 73037 0 11/9/2013 - 11/12/2013 ","."," 919,616.31 total pounds, for all products","Garden-Fresh Foods is recalling various cut vegetables, ready-to-eat salads, slaw, spread and dip products sold under various brands and code dates manufactured prior to November 06, 2013 because they may be contaminated with Listeria monocytogenes.",11/7/2013,"11/07/2013",12/26/2013,"12/26/2013"
"Food",66819,"Ongoing","Garden-Fresh Foods, Inc.","Milwaukee","WI","US","Voluntary: Firm Initiated","Press Release","IL, IN, MI, MN, MO, OH, PA, WI.","F-1078-2014","Class I","Finest Traditions, Tuna Pasta Salad, 1/8 lb., 10 733147 10067 4, 11/20/2013 - 12/9/2013; ","10 733147 10067 4, 11/20/2013 - 12/9/2013; ","."," 919,616.31 total pounds, for all products","Garden-Fresh Foods is recalling various cut vegetables, ready-to-eat salads, slaw, spread and dip products sold under various brands and code dates manufactured prior to November 06, 2013 because they may be contaminated with Listeria monocytogenes.",11/7/2013,"11/07/2013",12/26/2013,"12/26/2013"
"Food",66819,"Ongoing","Garden-Fresh Foods, Inc.","Milwaukee","WI","US","Voluntary: Firm Initiated","Press Release","IL, IN, MI, MN, MO, OH, PA, WI.","F-1064-2014","Class I","Finest Traditions, Strawberry Yogurt Cheesecake Dessert, 1/5 lb., 10 733147 11018 5, 11/20/2013 - 12/9/2013; Garden-Fresh, Strawberry Yogurt Cheesecake Dessert, 1/5 lb., 0 11 11596 55028 8 11/25/2013 - 12/7/2013; Old Tyme, Strawberry Yogurt Cheesecake Dessert, 1/5 lb., 0 94776 03303 4, 11/26/2013 - 11/29/2013 ;","10 733147 11018 5 11/20/2013 - 12/9/2013; 0 11 11596 55028 8 11/25/2013 - 12/7/2013; 0 94776 03303 4 11/26/2013 - 11/29/2013; ","."," 919,616.31 total pounds, for all products","Garden-Fresh Foods is recalling various cut vegetables, ready-to-eat salads, slaw, spread and dip products sold under various brands and code dates manufactured prior to November 06, 2013 because they may be contaminated with Listeria monocytogenes.",11/7/2013,"11/07/2013",12/26/2013,"12/26/2013"
"Food",66819,"Ongoing","Garden-Fresh Foods, Inc.","Milwaukee","WI","US","Voluntary: Firm Initiated","Press Release","IL, IN, MI, MN, MO, OH, PA, WI.","F-0847-2014","Class I","Garden-Fresh, 1/4'' x 1'' Yellow Pepper Sticks,2/2 lb., 0 11596 40587 2 11/9/2013-11/11/2013 ","11/9/2013-11/11/2013 ","."," 919,616.31 total pounds, for all products","Garden-Fresh Foods is recalling various cut vegetables, ready-to-eat salads, slaw, spread and dip products sold under various brands and code dates manufactured prior to November 06, 2013 because they may be contaminated with Listeria monocytogenes.",11/7/2013,"11/07/2013",12/26/2013,"12/26/2013"
"Food",66819,"Ongoing","Garden-Fresh Foods, Inc.","Milwaukee","WI","US","Voluntary: Firm Initiated","Press Release","IL, IN, MI, MN, MO, OH, PA, WI.","F-0968-2014","Class I","Dairy Fresh, Homemade Potato Salad, 2/5 lb., 0 70163 56575 3, 12/6/2013; ","0 70163 56575 3, 12/6/2013; ","."," 919,616.31 total pounds, for all products","Garden-Fresh Foods is recalling various cut vegetables, ready-to-eat salads, slaw, spread and dip products sold under various brands and code dates manufactured prior to November 06, 2013 because they may be contaminated with Listeria monocytogenes.",11/7/2013,"11/07/2013",12/26/2013,"12/26/2013"
"Food",66819,"Ongoing","Garden-Fresh Foods, Inc.","Milwaukee","WI","US","Voluntary: Firm Initiated","Press Release","IL, IN, MI, MN, MO, OH, PA, WI.","F-0986-2014","Class I","Dairy Fresh, Mexicalli Taco Pasta, 1/5 lb., 0 70163 55999 8,12/10/2013 ","0 70163 55999 8,12/10/2013 ","."," 919,616.31 total pounds, for all products","Garden-Fresh Foods is recalling various cut vegetables, ready-to-eat salads, slaw, spread and dip products sold under various brands and code dates manufactured prior to November 06, 2013 because they may be contaminated with Listeria monocytogenes.",11/7/2013,"11/07/2013",12/26/2013,"12/26/2013"
"Food",66819,"Ongoing","Garden-Fresh Foods, Inc.","Milwaukee","WI","US","Voluntary: Firm Initiated","Press Release","IL, IN, MI, MN, MO, OH, PA, WI.","F-0907-2014","Class I","Finest Traditions, Club Salad Kit, 1/3.75 lb.,10 733147 10977 6, 11/20/2013 - 12/9/2013; Garden-Fresh, Club Salad Kit, 1/3.75 lb., 0 11596 53043 7, 11/22/2013 - 12/2/2013 ;","10 733147 10977 6, 11/20/2013 - 12/9/2013; 0 11596 53043 7, 11/22/2013 - 12/2/2013 ;","."," 919,616.31 total pounds, for all products","Garden-Fresh Foods is recalling various cut vegetables, ready-to-eat salads, slaw, spread and dip products sold under various brands and code dates manufactured prior to November 06, 2013 because they may be contaminated with Listeria monocytogenes.",11/7/2013,"11/07/2013",12/26/2013,"12/26/2013"
"Food",66819,"Ongoing","Garden-Fresh Foods, Inc.","Milwaukee","WI","US","Voluntary: Firm Initiated","Press Release","IL, IN, MI, MN, MO, OH, PA, WI.","F-0922-2014","Class I","Garden-Fresh, Creamy Seafood Salad, 2/5 lb., 0 11596 55124 1, 0 00 11596 55124 1, 11/21/2013 - 12/10/2013 ","0 11596 55124 1, 0 00 11596 55124 1, 11/21/2013 - 12/10/2013 ","."," 919,616.31 total pounds, for all products","Garden-Fresh Foods is recalling various cut vegetables, ready-to-eat salads, slaw, spread and dip products sold under various brands and code dates manufactured prior to November 06, 2013 because they may be contaminated with Listeria monocytogenes.",11/7/2013,"11/07/2013",12/26/2013,"12/26/2013"
"Food",66819,"Ongoing","Garden-Fresh Foods, Inc.","Milwaukee","WI","US","Voluntary: Firm Initiated","Press Release","IL, IN, MI, MN, MO, OH, PA, WI.","F-1041-2014","Class I","Garden-Fresh, Seven Layer Salad Kit, 2/3.75 lb., 0 11596 85161 7, 12/2/2013 - 12/14/2013; ","0 11596 85161 7, 12/2/2013 - 12/14/2013; ","."," 919,616.31 total pounds, for all products","Garden-Fresh Foods is recalling various cut vegetables, ready-to-eat salads, slaw, spread and dip products sold under various brands and code dates manufactured prior to November 06, 2013 because they may be contaminated with Listeria monocytogenes.",11/7/2013,"11/07/2013",12/26/2013,"12/26/2013"
"Food",66819,"Ongoing","Garden-Fresh Foods, Inc.","Milwaukee","WI","US","Voluntary: Firm Initiated","Press Release","IL, IN, MI, MN, MO, OH, PA, WI.","F-0962-2014","Class I","Garden-Fresh, Green Onion Sliced, 1/2.5 lb., 0 11596 50598 5, 10/28/2013 - 11/16/2013 ","0 11596 50598 5, 10/28/2013 - 11/16/2013 ","."," 919,616.31 total pounds, for all products","Garden-Fresh Foods is recalling various cut vegetables, ready-to-eat salads, slaw, spread and dip products sold under various brands and code dates manufactured prior to November 06, 2013 because they may be contaminated with Listeria monocytogenes.",11/7/2013,"11/07/2013",12/26/2013,"12/26/2013"
"Food",66819,"Ongoing","Garden-Fresh Foods, Inc.","Milwaukee","WI","US","Voluntary: Firm Initiated","Press Release","IL, IN, MI, MN, MO, OH, PA, WI.","F-1051-2014","Class I","Dairy Fresh, Sour Cream Mac & Cheddar.2/5 lb, 0 70163 50043 3, 11/26/2013; Garden-Fresh, Sour Cream Mac & Cheddar, 2/5 lb., 0 11596 92031 3, 11/22/2013 - 12/7/2013; ","0 70163 50043 3, 11/26/2013; 0 11596 92031 3, 11/22/2013 - 12/7/2013; ","."," 919,616.31 total pounds, for all products","Garden-Fresh Foods is recalling various cut vegetables, ready-to-eat salads, slaw, spread and dip products sold under various brands and code dates manufactured prior to November 06, 2013 because they may be contaminated with Listeria monocytogenes.",11/7/2013,"11/07/2013",12/26/2013,"12/26/2013"
"Food",66819,"Ongoing","Garden-Fresh Foods, Inc.","Milwaukee","WI","US","Voluntary: Firm Initiated","Press Release","IL, IN, MI, MN, MO, OH, PA, WI.","F-1043-2014","Class I","Spoon River, Signature Macaroni Salad, 2/5 lb., 0 11596 55690 1, 11/21/2013 - 12/4/2013 ","0 11596 55690 1, 11/21/2013 - 12/4/2013 ","."," 919,616.31 total pounds, for all products","Garden-Fresh Foods is recalling various cut vegetables, ready-to-eat salads, slaw, spread and dip products sold under various brands and code dates manufactured prior to November 06, 2013 because they may be contaminated with Listeria monocytogenes.",11/7/2013,"11/07/2013",12/26/2013,"12/26/2013"
"Food",66819,"Ongoing","Garden-Fresh Foods, Inc.","Milwaukee","WI","US","Voluntary: Firm Initiated","Press Release","IL, IN, MI, MN, MO, OH, PA, WI.","F-0902-2014","Class I","Garden-Fresh, Cheddar Pasta Salad Kit, 1/4.6 lb. , 0 11596 62079 4, 11/9/2013 - 11/16/2013 ","0 11596 62079 4, 11/9/2013 - 11/16/2013 ","."," 919,616.31 total pounds, for all products","Garden-Fresh Foods is recalling various cut vegetables, ready-to-eat salads, slaw, spread and dip products sold under various brands and code dates manufactured prior to November 06, 2013 because they may be contaminated with Listeria monocytogenes.",11/7/2013,"11/07/2013",12/26/2013,"12/26/2013"
"Food",66819,"Ongoing","Garden-Fresh Foods, Inc.","Milwaukee","WI","US","Voluntary: Firm Initiated","Press Release","IL, IN, MI, MN, MO, OH, PA, WI.","F-1044-2014","Class I","Marsh, Signature Potato Salad, 2/5 lb., 0 11596 51085 9, 11/22/2013 - 12/10/2013; ","11596 51085 9, 11/22/2013 - 12/10/2013","."," 919,616.31 total pounds, for all products","Garden-Fresh Foods is recalling various cut vegetables, ready-to-eat salads, slaw, spread and dip products sold under various brands and code dates manufactured prior to November 06, 2013 because they may be contaminated with Listeria monocytogenes.",11/7/2013,"11/07/2013",12/26/2013,"12/26/2013"
"Food",66819,"Ongoing","Garden-Fresh Foods, Inc.","Milwaukee","WI","US","Voluntary: Firm Initiated","Press Release","IL, IN, MI, MN, MO, OH, PA, WI.","F-1019-2014","Class I","Garden-Fresh, Ranch Pasta Salad, 1/5 lb., 0 11596 52202 9, 11/25/2013 - 12/6/2013 ;","0 11596 52202 9, 11/25/2013 - 12/6/2013 ;","."," 919,616.31 total pounds, for all products","Garden-Fresh Foods is recalling various cut vegetables, ready-to-eat salads, slaw, spread and dip products sold under various brands and code dates manufactured prior to November 06, 2013 because they may be contaminated with Listeria monocytogenes.",11/7/2013,"11/07/2013",12/26/2013,"12/26/2013"
"Food",66819,"Ongoing","Garden-Fresh Foods, Inc.","Milwaukee","WI","US","Voluntary: Firm Initiated","Press Release","IL, IN, MI, MN, MO, OH, PA, WI.","F-1036-2014","Class I","Garden-Fresh, Seafood Salad, 1/5 lb., 0 11596 55102 9, 11/30/2013 - 12/11/2013; ","0 11596 55102 9, 11/30/2013 - 12/11/2013; ","."," 919,616.31 total pounds, for all products","Garden-Fresh Foods is recalling various cut vegetables, ready-to-eat salads, slaw, spread and dip products sold under various brands and code dates manufactured prior to November 06, 2013 because they may be contaminated with Listeria monocytogenes.",11/7/2013,"11/07/2013",12/26/2013,"12/26/2013"
"Food",66819,"Ongoing","Garden-Fresh Foods, Inc.","Milwaukee","WI","US","Voluntary: Firm Initiated","Press Release","IL, IN, MI, MN, MO, OH, PA, WI.","F-0882-2014","Class I","Garden-Fresh, Broccoli Florets, 1/5 lb., 0 11596 50515 2, 10/28/2013 ","0 11596 50515 2 10/28/2013 ","."," 919,616.31 total pounds, for all products","Garden-Fresh Foods is recalling various cut vegetables, ready-to-eat salads, slaw, spread and dip products sold under various brands and code dates manufactured prior to November 06, 2013 because they may be contaminated with Listeria monocytogenes.",11/7/2013,"11/07/2013",12/26/2013,"12/26/2013"
"Food",66819,"Ongoing","Garden-Fresh Foods, Inc.","Milwaukee","WI","US","Voluntary: Firm Initiated","Press Release","IL, IN, MI, MN, MO, OH, PA, WI.","F-0949-2014","Class II","Finest Traditions, Fresh Salsa Spicy, 6/11 oz., 10 733147 10996 7, 12/9/2013 ","10 733147 10996 7, 12/9/2013 ","."," 919,616.31 total pounds, for all products","Garden-Fresh Foods is recalling various cut vegetables, ready-to-eat salads, slaw, spread and dip products sold under various brands and code dates manufactured prior to November 06, 2013 because they may be contaminated with Listeria monocytogenes.",11/7/2013,"11/07/2013",12/26/2013,"12/26/2013"
"Food",66819,"Ongoing","Garden-Fresh Foods, Inc.","Milwaukee","WI","US","Voluntary: Firm Initiated","Press Release","IL, IN, MI, MN, MO, OH, PA, WI.","F-0956-2014","Class I","Garden-Fresh, German Potato Salad, 2/5 lb., 0 11596 91020 8, 11/21/2013 - 12/9/2013; Garden-Fresh, German Potato Salad, 12/16 oz,. 0 11596 14017 9, 0 11596 14017 9, 11/25/2013 - 12/5/2013; Garden-Fresh, German Potato Salad, 4/48 oz.., 0 11596 34319 8, 0 00 11596 44319 5, 11/21/2013 - 12/9/2013; Grandpa's, German Potato Salad, 2/5 lb., 0 11596 91023 9, 12/5/2013 - 12/14/2013; Grandpa's, German Potato Salad, 12/16 oz., 0 11596 14016 2, 0 00 11596 24016 9, 12/5/2013; "," 0 11596 91020 8 11/21/2013 - 12/9/2013; 0 11596 14017 9 0 11596 14017 9 11/25/2013 - 12/5/2013; 0 11596 34319 8 0 00 11596 44319 5 11/21/2013 - 12/9/2013; 0 11596 91023 9 12/5/2013 - 12/14/2013; 0 11596 14016 2 0 00 11596 24016 9 12/5/2013; ","."," 919,616.31 total pounds, for all products","Garden-Fresh Foods is recalling various cut vegetables, ready-to-eat salads, slaw, spread and dip products sold under various brands and code dates manufactured prior to November 06, 2013 because they may be contaminated with Listeria monocytogenes.",11/7/2013,"11/07/2013",12/26/2013,"12/26/2013"
"Food",66819,"Ongoing","Garden-Fresh Foods, Inc.","Milwaukee","WI","US","Voluntary: Firm Initiated","Press Release","IL, IN, MI, MN, MO, OH, PA, WI.","F-1035-2014","Class I","Garden-Fresh, Seafood Pasta Salad, 1/5 lb., 0 11596 55007 7, 11/25/2013 - 12/10/2013; ","0 11596 55007 7, 11/25/2013 - 12/10/2013; ","."," 919,616.31 total pounds, for all products","Garden-Fresh Foods is recalling various cut vegetables, ready-to-eat salads, slaw, spread and dip products sold under various brands and code dates manufactured prior to November 06, 2013 because they may be contaminated with Listeria monocytogenes.",11/7/2013,"11/07/2013",12/26/2013,"12/26/2013"
"Food",66819,"Ongoing","Garden-Fresh Foods, Inc.","Milwaukee","WI","US","Voluntary: Firm Initiated","Press Release","IL, IN, MI, MN, MO, OH, PA, WI.","F-0930-2014","Class I","Garden-Fresh, Deviled Egg Salad, 1/5 lb., 0 11596 52122 0, 11/20/2013 - 12/5/2013; Grandpa's, Deviled Egg Salad, 6/16 oz., 0 11596 14012 4, 0 00 11596 14012 4 , 11/26/2013 - 12/9/2013; ;","0 11596 52122 0 11/20/2013 - 12/5/2013; 0 00 11596 14012 4 11/26/2013 - 12/9/2013 ","."," 919,616.31 total pounds, for all products","Garden-Fresh Foods is recalling various cut vegetables, ready-to-eat salads, slaw, spread and dip products sold under various brands and code dates manufactured prior to November 06, 2013 because they may be contaminated with Listeria monocytogenes.",11/7/2013,"11/07/2013",12/26/2013,"12/26/2013"
"Food",66819,"Ongoing","Garden-Fresh Foods, Inc.","Milwaukee","WI","US","Voluntary: Firm Initiated","Press Release","IL, IN, MI, MN, MO, OH, PA, WI.","F1059-2014","Class I","Weis, Spiral Pasta Salad, 1/5 lb., 0 11596 52107 7, 11/21/2013 - 12/3/2013 ","0 11596 52107 7, 11/21/2013 - 12/3/2013 ","."," 919,616.31 total pounds, for all products","Garden-Fresh Foods is recalling various cut vegetables, ready-to-eat salads, slaw, spread and dip products sold under various brands and code dates manufactured prior to November 06, 2013 because they may be contaminated with Listeria monocytogenes.",11/7/2013,"11/07/2013",12/26/2013,"12/26/2013"
"Food",66819,"Ongoing","Garden-Fresh Foods, Inc.","Milwaukee","WI","US","Voluntary: Firm Initiated","Press Release","IL, IN, MI, MN, MO, OH, PA, WI.","F-1023-2014","Class I","Garden-Fresh, Red Potato & Spinach Salad, 1/5 lb., 0 11596 52140 4, 11/28/2013 - 12/10/2013; ","0 11596 52140 4, 11/28/2013 - 12/10/2013; ","."," 919,616.31 total pounds, for all products","Garden-Fresh Foods is recalling various cut vegetables, ready-to-eat salads, slaw, spread and dip products sold under various brands and code dates manufactured prior to November 06, 2013 because they may be contaminated with Listeria monocytogenes.",11/7/2013,"11/07/2013",12/26/2013,"12/26/2013"
"Food",66819,"Ongoing","Garden-Fresh Foods, Inc.","Milwaukee","WI","US","Voluntary: Firm Initiated","Press Release","IL, IN, MI, MN, MO, OH, PA, WI.","F-0945-2014","Class II","Farmer's Market, Fresh Salsa Habanero Hot, 6/15 oz., 0 11596 06144 3 0 00 11596 06144 3, 12/15/2013; ","0 11596 06144 3 0 00 11596 06144 3, 12/15/2013; ","."," 919,616.31 total pounds, for all products","Garden-Fresh Foods is recalling various cut vegetables, ready-to-eat salads, slaw, spread and dip products sold under various brands and code dates manufactured prior to November 06, 2013 because they may be contaminated with Listeria monocytogenes.",11/7/2013,"11/07/2013",12/26/2013,"12/26/2013"
"Food",66819,"Ongoing","Garden-Fresh Foods, Inc.","Milwaukee","WI","US","Voluntary: Firm Initiated","Press Release","IL, IN, MI, MN, MO, OH, PA, WI.","F-0957-2014","Class I","Garden-Fresh, Gourmet Dill Potato Salad, 2/5 lb., 0 11596 55137 1, 11/27/2013 - 12/6/2013 ","0 11596 55137 1, 11/27/2013 - 12/6/2013 ","."," 919,616.31 total pounds, for all products","Garden-Fresh Foods is recalling various cut vegetables, ready-to-eat salads, slaw, spread and dip products sold under various brands and code dates manufactured prior to November 06, 2013 because they may be contaminated with Listeria monocytogenes.",11/7/2013,"11/07/2013",12/26/2013,"12/26/2013"
"Food",66819,"Ongoing","Garden-Fresh Foods, Inc.","Milwaukee","WI","US","Voluntary: Firm Initiated","Press Release","IL, IN, MI, MN, MO, OH, PA, WI.","F-0925-2014","Class I","Garden-Fresh, Deluxe BLT Pasta, 1/5 lb., 0 11596 52039 1, 11/26/2013 - 12/7/2013 ","0 11596 52039 1, 11/26/2013 - 12/7/2013 ","."," 919,616.31 total pounds, for all products","Garden-Fresh Foods is recalling various cut vegetables, ready-to-eat salads, slaw, spread and dip products sold under various brands and code dates manufactured prior to November 06, 2013 because they may be contaminated with Listeria monocytogenes.",11/7/2013,"11/07/2013",12/26/2013,"12/26/2013"
"Food",66819,"Ongoing","Garden-Fresh Foods, Inc.","Milwaukee","WI","US","Voluntary: Firm Initiated","Press Release","IL, IN, MI, MN, MO, OH, PA, WI.","F-0929-2014","Class I","Finest Traditions, Deviled Egg Potato Salad, 1/8 lb.,10 733147 10992 9,11/11/2013 - 11/25/2013; Grandpa's, Deviled Egg Potato Salad, 2/5 lb., 0 11596 51065 1,11/22/2013 - 12/10/2013; Grandpa's, Deviled Egg Potato Salad, 4/5 lb., 0 11596 51065 1, 11/28/2013 -2/10/2013; ","10 733147 10992 9 11/11/2013 - 11/25/2013; 0 11596 51065 1 11/22/2013 - 12/10/2013; 0 11596 51065 1 11/28/2013 -2/10/2013; ","."," 919,616.31 total pounds, for all products","Garden-Fresh Foods is recalling various cut vegetables, ready-to-eat salads, slaw, spread and dip products sold under various brands and code dates manufactured prior to November 06, 2013 because they may be contaminated with Listeria monocytogenes.",11/7/2013,"11/07/2013",12/26/2013,"12/26/2013"
"Food",66819,"Ongoing","Garden-Fresh Foods, Inc.","Milwaukee","WI","US","Voluntary: Firm Initiated","Press Release","IL, IN, MI, MN, MO, OH, PA, WI.","F-1068-2014","Class I","Garden-Fresh, Sweet Bow Tie Pasta with Bacon, 1/5 lb., 0 11 11596 52047 2 11/22/2013 - 12/7/2013; Old Tyme, Sweet Bow Tie Pasta with Bacon, 1/5 lb., 0 94776 03409 3, 11/22/2013 - 12/6/2013; "," 0 11 11596 52047 2 11/22/2013 - 12/7/2013; 0 94776 03409 3, 11/22/2013 - 12/6/2013; ","."," 919,616.31 total pounds, for all products","Garden-Fresh Foods is recalling various cut vegetables, ready-to-eat salads, slaw, spread and dip products sold under various brands and code dates manufactured prior to November 06, 2013 because they may be contaminated with Listeria monocytogenes.",11/7/2013,"11/07/2013",12/26/2013,"12/26/2013"
"Food",66819,"Ongoing","Garden-Fresh Foods, Inc.","Milwaukee","WI","US","Voluntary: Firm Initiated","Press Release","IL, IN, MI, MN, MO, OH, PA, WI.","F-0938-2014","Class I","Garden-Fresh, Fat Free Broccoli with Rigatoni Salad, 2/4 lb., 0 11596 52064 3, 11/9/2013 ","0 11596 52064 3, 11/9/2013 ","."," 919,616.31 total pounds, for all products","Garden-Fresh Foods is recalling various cut vegetables, ready-to-eat salads, slaw, spread and dip products sold under various brands and code dates manufactured prior to November 06, 2013 because they may be contaminated with Listeria monocytogenes.",11/7/2013,"11/07/2013",12/26/2013,"12/26/2013"
"Food",66819,"Ongoing","Garden-Fresh Foods, Inc.","Milwaukee","WI","US","Voluntary: Firm Initiated","Press Release","IL, IN, MI, MN, MO, OH, PA, WI.","F-1070-2014","Class I","Garden-Fresh, Taco Pasta Salad, 1/5 lb., 0 11596 52076 6 11/22/2013 - 12/17/2013 ","0 11596 52076 6 11/22/2013 - 12/17/2013 ","."," 919,616.31 total pounds, for all products","Garden-Fresh Foods is recalling various cut vegetables, ready-to-eat salads, slaw, spread and dip products sold under various brands and code dates manufactured prior to November 06, 2013 because they may be contaminated with Listeria monocytogenes.",11/7/2013,"11/07/2013",12/26/2013,"12/26/2013"
"Food",66819,"Ongoing","Garden-Fresh Foods, Inc.","Milwaukee","WI","US","Voluntary: Firm Initiated","Press Release","IL, IN, MI, MN, MO, OH, PA, WI.","F-1025-2014","Class I","Dairy Fresh, Red Skin Potato & Herb, 1/5 lb., 0 70163 53370 7, 12/3/2013 - 12/10/2013; ","00 70163 53370 7, 12/3/2013 - 12/10/2013; ","."," 919,616.31 total pounds, for all products","Garden-Fresh Foods is recalling various cut vegetables, ready-to-eat salads, slaw, spread and dip products sold under various brands and code dates manufactured prior to November 06, 2013 because they may be contaminated with Listeria monocytogenes.",11/7/2013,"11/07/2013",12/26/2013,"12/26/2013"
"Food",66819,"Ongoing","Garden-Fresh Foods, Inc.","Milwaukee","WI","US","Voluntary: Firm Initiated","Press Release","IL, IN, MI, MN, MO, OH, PA, WI.","F-0881-2014","Class I","Garden-Fresh, Broccoli Cranberry Cole Slaw Kit, 1/3.15 lb. ,0 11 11596 43029 0, 11/9/2013 - 11/11/2013 ","0 11 11596 43029 0, 11/9/2013 - 11/11/2013 ","."," 919,616.31 total pounds, for all products","Garden-Fresh Foods is recalling various cut vegetables, ready-to-eat salads, slaw, spread and dip products sold under various brands and code dates manufactured prior to November 06, 2013 because they may be contaminated with Listeria monocytogenes.",11/7/2013,"11/07/2013",12/26/2013,"12/26/2013"
"Food",66819,"Ongoing","Garden-Fresh Foods, Inc.","Milwaukee","WI","US","Voluntary: Firm Initiated","Press Release","IL, IN, MI, MN, MO, OH, PA, WI.","F-1074-2014","Class I","Finest Traditions, Ties & Tomatoes Pasta Salad, 1/8 lb., 10 733147 10686 7, 11/20/2013 - 12/9/2013; ","10 733147 10686 7, 11/20/2013 - 12/9/2013; ","."," 919,616.31 total pounds, for all products","Garden-Fresh Foods is recalling various cut vegetables, ready-to-eat salads, slaw, spread and dip products sold under various brands and code dates manufactured prior to November 06, 2013 because they may be contaminated with Listeria monocytogenes.",11/7/2013,"11/07/2013",12/26/2013,"12/26/2013"
"Food",66819,"Ongoing","Garden-Fresh Foods, Inc.","Milwaukee","WI","US","Voluntary: Firm Initiated","Press Release","IL, IN, MI, MN, MO, OH, PA, WI.","F-1052-2014","Class I","Finest Traditions, Southwest Dip, 1/8 lb., 10 733147 10125. 1, 12/4/2013; Finest Traditions Southwest Dip, 6/8 oz., 7 33147 10540 5, 10 733147 10541 9, 11/20/2013 - 12/9/2013; ","10 733147 10125. 1, 12/4/2013; 33147 10540 5, 10 733147 10541 9, 11/20/2013 - 12/9/2013; ","."," 919,616.31 total pounds, for all products","Garden-Fresh Foods is recalling various cut vegetables, ready-to-eat salads, slaw, spread and dip products sold under various brands and code dates manufactured prior to November 06, 2013 because they may be contaminated with Listeria monocytogenes.",11/7/2013,"11/07/2013",12/26/2013,"12/26/2013"
"Food",66819,"Ongoing","Garden-Fresh Foods, Inc.","Milwaukee","WI","US","Voluntary: Firm Initiated","Press Release","IL, IN, MI, MN, MO, OH, PA, WI.","F-0918-2014","Class I","Finest Traditions, Creamy Cheddar Macaroni Salad, 1/8 lb., 10 733147 10156 5, 11/20/2013 - 12/9/2013 ","10 733147 10156 5, 11/20/2013 - 12/9/2013 ","."," 919,616.31 total pounds, for all products","Garden-Fresh Foods is recalling various cut vegetables, ready-to-eat salads, slaw, spread and dip products sold under various brands and code dates manufactured prior to November 06, 2013 because they may be contaminated with Listeria monocytogenes.",11/7/2013,"11/07/2013",12/26/2013,"12/26/2013"
"Food",66819,"Ongoing","Garden-Fresh Foods, Inc.","Milwaukee","WI","US","Voluntary: Firm Initiated","Press Release","IL, IN, MI, MN, MO, OH, PA, WI.","F-0883-2014","Class I","Spoon River Buttermilk Ranch Dip 6/12 oz. 0 11596 05684 5 0 00 11596 05684 5 12/16/2013 - 12/31/2013 Spoon River, Buttermilk Ranch Dip, 1/5 lb., 0 11596 55685 7, 12/16/2013 - 12/31/2013 ","0 11596 55685 7, 12/16/2013 - 12/31/2013 ","."," 919,616.31 total pounds, for all products","Garden-Fresh Foods is recalling various cut vegetables, ready-to-eat salads, slaw, spread and dip products sold under various brands and code dates manufactured prior to November 06, 2013 because they may be contaminated with Listeria monocytogenes.",11/7/2013,"11/07/2013",12/26/2013,"12/26/2013"
"Food",66819,"Ongoing","Garden-Fresh Foods, Inc.","Milwaukee","WI","US","Voluntary: Firm Initiated","Press Release","IL, IN, MI, MN, MO, OH, PA, WI.","F-1027-2014","Class I","Garden-Fresh, Reduced Fat Mustard Potato Salad, 1/5 lb., 0 11596 51202 0, 12/6/2013 - 12/16/2013; ","0 11596 51202 0, 12/6/2013 - 12/16/2013; ","."," 919,616.31 total pounds, for all products","Garden-Fresh Foods is recalling various cut vegetables, ready-to-eat salads, slaw, spread and dip products sold under various brands and code dates manufactured prior to November 06, 2013 because they may be contaminated with Listeria monocytogenes.",11/7/2013,"11/07/2013",12/26/2013,"12/26/2013"
"Food",66819,"Ongoing","Garden-Fresh Foods, Inc.","Milwaukee","WI","US","Voluntary: Firm Initiated","Press Release","IL, IN, MI, MN, MO, OH, PA, WI.","F-0994-2014","Class I","Weis, Original Macaroni Salad, 6/16 oz., 0 41497 05839 6, 0 00 41497 05839 6, 11/25/2013 - 12/3/2013; Weis, Original Macaroni Salad, 4/3 lb., 0 41497 05904 1, 0 00 41497 05904 1, 11/21/2013 - 11/28/2013; Weis, Original Macaroni Salad, 2/5 lb., 0 11596 52106 0, 11/21/2013 - 12/3/2013; ","0 41497 05839 6, 0 00 41497 05839 6, 11/25/2013 - 12/3/2013; 0 41497 05904 1, 0 00 41497 05904 1, 11/21/2013 - 11/28/2013; 0 11596 52106 0, 11/21/2013 - 12/3/2013; ","."," 919,616.31 total pounds, for all products","Garden-Fresh Foods is recalling various cut vegetables, ready-to-eat salads, slaw, spread and dip products sold under various brands and code dates manufactured prior to November 06, 2013 because they may be contaminated with Listeria monocytogenes.",11/7/2013,"11/07/2013",12/26/2013,"12/26/2013"
"Food",66819,"Ongoing","Garden-Fresh Foods, Inc.","Milwaukee","WI","US","Voluntary: Firm Initiated","Press Release","IL, IN, MI, MN, MO, OH, PA, WI.","F-0991-2014","Class I","Weis, Old Fashioned Cole Slaw, 6/16 oz., 0 41497 05849 5, 0 00 41497 05849 5, 11/21/2013 - 12/3/2013 Weis, Old Fashioned Cole Slaw, 2/5 lb., 0 11596 53100 7, 11/21/2013 - 12/2/2013 ","0 41497 05849 5, 0 00 41497 05849 5, 11/21/2013 - 12/3/2013; 0 11596 53100 7, 11/21/2013 - 12/2/2013 ;","."," 919,616.31 total pounds, for all products","Garden-Fresh Foods is recalling various cut vegetables, ready-to-eat salads, slaw, spread and dip products sold under various brands and code dates manufactured prior to November 06, 2013 because they may be contaminated with Listeria monocytogenes.",11/7/2013,"11/07/2013",12/26/2013,"12/26/2013"
"Food",66819,"Ongoing","Garden-Fresh Foods, Inc.","Milwaukee","WI","US","Voluntary: Firm Initiated","Press Release","IL, IN, MI, MN, MO, OH, PA, WI.","F-1056-2014","Class I","Finest Traditions, Spinach Dip 1/8 lb., 10 733147 10123 7, 11/20/2013 - 12/9/2013 Finest Traditions, Spinach Dip 6/8 oz., 7 33147 10538 2, 10 733147 10539 6, 11/20/2013 - 12/11/2013 Grandpa's, Spinach Dip, 1/5 lb., 0 11596 55901 8, 12/23/2013- 12/31/2013 Our Own, Spinach Dip ,1/5 lb., 0 11596 55149 4, 12/1/2013 - 12/19/2013 Spoon River, Spinach Dip ,1/5 lb., 0 1159655681 9, 12/16/2013 - 12/31/2013 "," 10 733147 10123 7 11/20/2013 - 12/9/2013; 7 33147 10538 2 10 733147 10539 6 11/20/2013 - 12/11/2013; 0 11596 55901 8 12/23/2013- 12/31/2013; 0 11596 55149 4 12/1/2013 - 12/19/2013; 0 1159655681 9 12/16/2013 - 12/31/2013 ;","."," 919,616.31 total pounds, for all products","Garden-Fresh Foods is recalling various cut vegetables, ready-to-eat salads, slaw, spread and dip products sold under various brands and code dates manufactured prior to November 06, 2013 because they may be contaminated with Listeria monocytogenes.",11/7/2013,"11/07/2013",12/26/2013,"12/26/2013"
"Food",66819,"Ongoing","Garden-Fresh Foods, Inc.","Milwaukee","WI","US","Voluntary: Firm Initiated","Press Release","IL, IN, MI, MN, MO, OH, PA, WI.","F-1026-2014","Class I","Garden-Fresh, Reduced Fat Cole Slaw, 1/5 lb., 0 11596 53202 8, 12/6/2013 - 12/15/2013; Garden-Fresh, Reduced Fat Cole Slaw, 4/5 lb., 0 11596 53500 5, 12/6/2013 - 12/14/2013; ","0 11596 53202 8 12/6/2013 - 12/15/2013; 0 11596 53500 5 12/6/2013 - 12/14/2013 ","."," 919,616.31 total pounds, for all products","Garden-Fresh Foods is recalling various cut vegetables, ready-to-eat salads, slaw, spread and dip products sold under various brands and code dates manufactured prior to November 06, 2013 because they may be contaminated with Listeria monocytogenes.",11/7/2013,"11/07/2013",12/26/2013,"12/26/2013"
"Food",66819,"Ongoing","Garden-Fresh Foods, Inc.","Milwaukee","WI","US","Voluntary: Firm Initiated","Press Release","IL, IN, MI, MN, MO, OH, PA, WI.","F-1080-2014","Class I","Finest Traditions, Tuna Salad Spread, 2/4 lb., 10 733147 10186 2, 11/30/2013 - 12/14/2013; Holiday Pantry, Tuna Salad Spread, 4/8 lb., 10 733147 10780 2, 11/25/2013; ","10 733147 10186 2, 11/30/2013 - 12/14/2013; 10 733147 10780 2, 11/25/2013; ","."," 919,616.31 total pounds, for all products","Garden-Fresh Foods is recalling various cut vegetables, ready-to-eat salads, slaw, spread and dip products sold under various brands and code dates manufactured prior to November 06, 2013 because they may be contaminated with Listeria monocytogenes.",11/7/2013,"11/07/2013",12/26/2013,"12/26/2013"
"Food",66819,"Ongoing","Garden-Fresh Foods, Inc.","Milwaukee","WI","US","Voluntary: Firm Initiated","Press Release","IL, IN, MI, MN, MO, OH, PA, WI.","F-1011-2014","Class I","Garden-Fresh, Premium Asiago Pasta Salad, 1/4 lb., 0 11596 45624 9, 12/2/2013 - 12/11/2013; ","0 11596 45624 9, 12/2/2013 - 12/11/2013; ","."," 919,616.31 total pounds, for all products","Garden-Fresh Foods is recalling various cut vegetables, ready-to-eat salads, slaw, spread and dip products sold under various brands and code dates manufactured prior to November 06, 2013 because they may be contaminated with Listeria monocytogenes.",11/7/2013,"11/07/2013",12/26/2013,"12/26/2013"
"Food",66819,"Ongoing","Garden-Fresh Foods, Inc.","Milwaukee","WI","US","Voluntary: Firm Initiated","Press Release","IL, IN, MI, MN, MO, OH, PA, WI.","F-0887-2014","Class I","Martin's, Caesar Salad Kit, 1/3.625 lb., 0 11596 40182 9, 11/9/2013 - 11/16/2013 ","0 11596 40182 9, 11/9/2013 - 11/16/2013 ","."," 919,616.31 total pounds, for all products","Garden-Fresh Foods is recalling various cut vegetables, ready-to-eat salads, slaw, spread and dip products sold under various brands and code dates manufactured prior to November 06, 2013 because they may be contaminated with Listeria monocytogenes.",11/7/2013,"11/07/2013",12/26/2013,"12/26/2013"
"Food",66819,"Ongoing","Garden-Fresh Foods, Inc.","Milwaukee","WI","US","Voluntary: Firm Initiated","Press Release","IL, IN, MI, MN, MO, OH, PA, WI.","F-0969-2014","Class I","Finest Traditions, Homemade-style Cole Slaw, 1/8 lb., 10 733147 10170 1, 11/20/2013 - 12/4/2013; Finest Traditions, Homemade-style Cole Slaw, 6/16 oz., 7 33147 00025 0, 10 733147 10165 7, 11/20/2013 - 12/4/2013; ","10 733147 10170 1, 11/20/2013 - 12/4/2013; 7 33147 00025 0, 10 733147 10165 7, 11/20/2013 - 12/4/2013; ","."," 919,616.31 total pounds, for all products","Garden-Fresh Foods is recalling various cut vegetables, ready-to-eat salads, slaw, spread and dip products sold under various brands and code dates manufactured prior to November 06, 2013 because they may be contaminated with Listeria monocytogenes.",11/7/2013,"11/07/2013",12/26/2013,"12/26/2013"
"Food",66819,"Ongoing","Garden-Fresh Foods, Inc.","Milwaukee","WI","US","Voluntary: Firm Initiated","Press Release","IL, IN, MI, MN, MO, OH, PA, WI.","F-1009-2014","Class I","Family Style, Potato Salad, 2/5 lb., 0 11596 51061 3, 11/27/2013; Grandpa's, Potato Salad, 2/5 lb., 0 11596 91026 0, 11/27/2013 - 12/10/2013; Grandpa's, Potato Salad, 12/16 oz., 0 11596 14027 8, 0 11596 24027 5, 11/21/2013 - 12/10/2013; Grandpa's, Potato Salad, 12/16 oz., 0 11596 14027 8, 0 11596 24027 5, 11/25/2013 - 12/9/2013; Grandpa's, Potato Salad, 4/48 oz.,. 0 11596 34326 6, 0 00 11596 44326 3, 11/21/2013 - 12/10/2013; Grandpa's Potato Salad, 18/3.5 oz., 0 11596 08005 5, 0 00 11596 08005 5, 11/21/2013 - 12/9/2013; Spoon River, Potato Salad, 2/5 lb., 0 11596 51032 3, 11/28/2013 - 12/5/2013; "," 0 11596 51061 3 11/27/2013; 0 11596 91026 0 11/27/2013 - 12/10/2013; 0 11596 14027 8 0 11596 24027 5 11/21/2013 - 12/10/2013; 0 11596 14027 8 0 11596 24027 5 11/25/2013 - 12/9/2013; 0 11596 34326 6 0 00 11596 44326 3 11/21/2013 - 12/10/2013; 0 11596 08005 5 0 00 11596 08005 5 11/21/2013 - 12/9/2013; 0 11596 51032 3 11/28/2013 - 12/5/2013 ;","."," 919,616.31 total pounds, for all products","Garden-Fresh Foods is recalling various cut vegetables, ready-to-eat salads, slaw, spread and dip products sold under various brands and code dates manufactured prior to November 06, 2013 because they may be contaminated with Listeria monocytogenes.",11/7/2013,"11/07/2013",12/26/2013,"12/26/2013"
"Food",66819,"Ongoing","Garden-Fresh Foods, Inc.","Milwaukee","WI","US","Voluntary: Firm Initiated","Press Release","IL, IN, MI, MN, MO, OH, PA, WI.","F-1002-2014","Class I","Finest Traditions, Penne Pasta with Roma Tomatoes, 1/8 lb., 10 733147 10286 9, 11/25/2013 - 12/9/2013; ","10 733147 10286 9, 11/25/2013 - 12/9/2013","."," 919,616.31 total pounds, for all products","Garden-Fresh Foods is recalling various cut vegetables, ready-to-eat salads, slaw, spread and dip products sold under various brands and code dates manufactured prior to November 06, 2013 because they may be contaminated with Listeria monocytogenes.",11/7/2013,"11/07/2013",12/26/2013,"12/26/2013"
"Food",66819,"Ongoing","Garden-Fresh Foods, Inc.","Milwaukee","WI","US","Voluntary: Firm Initiated","Press Release","IL, IN, MI, MN, MO, OH, PA, WI.","F-0951-2014","Class I","Our Own, Garden Pasta Salad, 1/5 lb., 0 11596 52153 4, 11/22/2013 - 12/6/2013; ","0 11596 52153 4, 11/22/2013 - 12/6/2013; ","."," 919,616.31 total pounds, for all products","Garden-Fresh Foods is recalling various cut vegetables, ready-to-eat salads, slaw, spread and dip products sold under various brands and code dates manufactured prior to November 06, 2013 because they may be contaminated with Listeria monocytogenes.",11/7/2013,"11/07/2013",12/26/2013,"12/26/2013"
"Food",66819,"Ongoing","Garden-Fresh Foods, Inc.","Milwaukee","WI","US","Voluntary: Firm Initiated","Press Release","IL, IN, MI, MN, MO, OH, PA, WI.","F-1066-2014","Class I","Garden-Fresh, Sun Garden Salad, 1/4 lb., 0 11596 42059 2, 11/17/2013 - 12/1/2013; Garden-Fresh, Sun Garden Salad, 4/4 lb., 0 11596 42502 3, 11/17/2013 - 11/27/2013; ","0 11596 42059 2, 11/17/2013 - 12/1/2013; 0 11596 42502 3, 11/17/2013 - 11/27/2013; ","."," 919,616.31 total pounds, for all products","Garden-Fresh Foods is recalling various cut vegetables, ready-to-eat salads, slaw, spread and dip products sold under various brands and code dates manufactured prior to November 06, 2013 because they may be contaminated with Listeria monocytogenes.",11/7/2013,"11/07/2013",12/26/2013,"12/26/2013"
"Food",66819,"Ongoing","Garden-Fresh Foods, Inc.","Milwaukee","WI","US","Voluntary: Firm Initiated","Press Release","IL, IN, MI, MN, MO, OH, PA, WI.","F-1082-2014","Class I","Garden-Fresh, Twice Baked Potato Salad Kit, 1/5.25 lb., 0 11596 61069 6, 11/9/2013 - 11/13/2013; ","0 11596 61069 6, 11/9/2013 - 11/13/2013; ","."," 919,616.31 total pounds, for all products","Garden-Fresh Foods is recalling various cut vegetables, ready-to-eat salads, slaw, spread and dip products sold under various brands and code dates manufactured prior to November 06, 2013 because they may be contaminated with Listeria monocytogenes.",11/7/2013,"11/07/2013",12/26/2013,"12/26/2013"
"Food",66819,"Ongoing","Garden-Fresh Foods, Inc.","Milwaukee","WI","US","Voluntary: Firm Initiated","Press Release","IL, IN, MI, MN, MO, OH, PA, WI.","F-1083-2014","Class I","Grandpa's, Vegetable Bagel Spread, 1/5 lb., 0 11596 55905 6, 11/11/2013 - 11/30/2013; ","0 11596 55905 6, 11/11/2013 - 11/30/2013; ","."," 919,616.31 total pounds, for all products","Garden-Fresh Foods is recalling various cut vegetables, ready-to-eat salads, slaw, spread and dip products sold under various brands and code dates manufactured prior to November 06, 2013 because they may be contaminated with Listeria monocytogenes.",11/7/2013,"11/07/2013",12/26/2013,"12/26/2013"
"Food",66819,"Ongoing","Garden-Fresh Foods, Inc.","Milwaukee","WI","US","Voluntary: Firm Initiated","Press Release","IL, IN, MI, MN, MO, OH, PA, WI.","F-0935-2014","Class I","Garden-Fresh European Style Chocolate Mousse 1/5 lb. 0 11596 55085 5 11/16/2013 - 12/5/2013 ","0 11596 55085 5 11/16/2013 - 12/5/2013 ","."," 919,616.31 total pounds, for all products","Garden-Fresh Foods is recalling various cut vegetables, ready-to-eat salads, slaw, spread and dip products sold under various brands and code dates manufactured prior to November 06, 2013 because they may be contaminated with Listeria monocytogenes.",11/7/2013,"11/07/2013",12/26/2013,"12/26/2013"
"Food",66819,"Ongoing","Garden-Fresh Foods, Inc.","Milwaukee","WI","US","Voluntary: Firm Initiated","Press Release","IL, IN, MI, MN, MO, OH, PA, WI.","F-1042-2014","Class I","Garden-Fresh, Shrimp Salad, 1/5 lb., 0 11596 55100 5, 11/25/2013 - 12/7/2013; ","0 11596 55100 5, 11/25/2013 - 12/7/2013; ","."," 919,616.31 total pounds, for all products","Garden-Fresh Foods is recalling various cut vegetables, ready-to-eat salads, slaw, spread and dip products sold under various brands and code dates manufactured prior to November 06, 2013 because they may be contaminated with Listeria monocytogenes.",11/7/2013,"11/07/2013",12/26/2013,"12/26/2013"
"Food",66819,"Ongoing","Garden-Fresh Foods, Inc.","Milwaukee","WI","US","Voluntary: Firm Initiated","Press Release","IL, IN, MI, MN, MO, OH, PA, WI.","F-1020-2014","Class I","Garden-Fresh, Red Cabbage Shredded, 1/5 lb., 0 11596 50590, Manufactured on 10/28/2013 - 11/6/2013; Garden-Fresh, Red Cabbage Shredded 4/5 lb., 0 11596 50592 3, 10/28/2013 - 11/6/2013; ","0 11596 50590 10/28/2013 - 11/6/2013; 0 11596 50592 3 10/28/2013 - 11/6/2013 ;","."," 919,616.31 total pounds, for all products","Garden-Fresh Foods is recalling various cut vegetables, ready-to-eat salads, slaw, spread and dip products sold under various brands and code dates manufactured prior to November 06, 2013 because they may be contaminated with Listeria monocytogenes.",11/7/2013,"11/07/2013",12/26/2013,"12/26/2013"
"Food",66819,"Ongoing","Garden-Fresh Foods, Inc.","Milwaukee","WI","US","Voluntary: Firm Initiated","Press Release","IL, IN, MI, MN, MO, OH, PA, WI.","F-1005-2014","Class I","Garden-Fresh, Pineapple Dessert, 1/10 lb., 0 11596 95050 1, 12/4/2013; ","0 11596 95050 1, 12/4/2013; ","."," 919,616.31 total pounds, for all products","Garden-Fresh Foods is recalling various cut vegetables, ready-to-eat salads, slaw, spread and dip products sold under various brands and code dates manufactured prior to November 06, 2013 because they may be contaminated with Listeria monocytogenes.",11/7/2013,"11/07/2013",12/26/2013,"12/26/2013"
"Food",66819,"Ongoing","Garden-Fresh Foods, Inc.","Milwaukee","WI","US","Voluntary: Firm Initiated","Press Release","IL, IN, MI, MN, MO, OH, PA, WI.","F-1055-2014","Class I","Garden-Fresh, Spaghetti Salad, 1/5 lb., 0 11 11596 52130 1, 11/22/2013 -12/6/2013 Garden-Fresh, Spaghetti Salad, 4/5 lb., 0 11596 52501 3, 11/22/2013 - 11/28/213 ","0 11 11596 52130 1, 11/22/2013 -12/6/2013; 0 11596 52501 3, 11/22/2013 - 11/28/213 ","."," 919,616.31 total pounds, for all products","Garden-Fresh Foods is recalling various cut vegetables, ready-to-eat salads, slaw, spread and dip products sold under various brands and code dates manufactured prior to November 06, 2013 because they may be contaminated with Listeria monocytogenes.",11/7/2013,"11/07/2013",12/26/2013,"12/26/2013"
"Food",66819,"Ongoing","Garden-Fresh Foods, Inc.","Milwaukee","WI","US","Voluntary: Firm Initiated","Press Release","IL, IN, MI, MN, MO, OH, PA, WI.","F-1030-2014","Class I","Finest Traditions, Roasted Garlic Potato Salad, 1/8 lb., 10 733147 10159 6, 11/25/2013 - 12/9/2013; ","10 733147 10159 6, 11/25/2013 - 12/9/2013; ; ","."," 919,616.31 total pounds, for all products","Garden-Fresh Foods is recalling various cut vegetables, ready-to-eat salads, slaw, spread and dip products sold under various brands and code dates manufactured prior to November 06, 2013 because they may be contaminated with Listeria monocytogenes.",11/7/2013,"11/07/2013",12/26/2013,"12/26/2013"
"Food",66819,"Ongoing","Garden-Fresh Foods, Inc.","Milwaukee","WI","US","Voluntary: Firm Initiated","Press Release","IL, IN, MI, MN, MO, OH, PA, WI.","F-1001-2014","Class I","Garden-Fresh, Penne Pasta with Grape Tomatoes, 1/5 lb., 0 11596 55625 3, 11/16/2013 - 11/23/2013; ","0 11596 55625 3, 11/16/2013 - 11/23/2013; ","."," 919,616.31 total pounds, for all products","Garden-Fresh Foods is recalling various cut vegetables, ready-to-eat salads, slaw, spread and dip products sold under various brands and code dates manufactured prior to November 06, 2013 because they may be contaminated with Listeria monocytogenes.",11/7/2013,"11/07/2013",12/26/2013,"12/26/2013"
"Food",66819,"Ongoing","Garden-Fresh Foods, Inc.","Milwaukee","WI","US","Voluntary: Firm Initiated","Press Release","IL, IN, MI, MN, MO, OH, PA, WI.","F-1088-2014","Class I","Garden-Fresh, Watergate Salad, 1/8 lb., 0 11596 85086 3, 12/1/2013 - 12/19/2013; ","0 11596 85086 3, 12/1/2013 - 12/19/2013","."," 919,616.31 total pounds, for all products","Garden-Fresh Foods is recalling various cut vegetables, ready-to-eat salads, slaw, spread and dip products sold under various brands and code dates manufactured prior to November 06, 2013 because they may be contaminated with Listeria monocytogenes.",11/7/2013,"11/07/2013",12/26/2013,"12/26/2013"
"Food",66819,"Ongoing","Garden-Fresh Foods, Inc.","Milwaukee","WI","US","Voluntary: Firm Initiated","Press Release","IL, IN, MI, MN, MO, OH, PA, WI.","F-0960-2014","Class I","Garden-Fresh, Greek Style Pasta with Feta, 1/5 lb., 0 11596 52033 9, 11/22/2013 - 12/7/2013 ","0 11596 52033 9, 11/22/2013 - 12/7/2013 ","."," 919,616.31 total pounds, for all products","Garden-Fresh Foods is recalling various cut vegetables, ready-to-eat salads, slaw, spread and dip products sold under various brands and code dates manufactured prior to November 06, 2013 because they may be contaminated with Listeria monocytogenes.",11/7/2013,"11/07/2013",12/26/2013,"12/26/2013"
"Food",66819,"Ongoing","Garden-Fresh Foods, Inc.","Milwaukee","WI","US","Voluntary: Firm Initiated","Press Release","IL, IN, MI, MN, MO, OH, PA, WI.","F-1077-2014","Class I","Garden-Fresh, Tropical Waldorf Salad Kit, 1/6.0625 0 11596 65047 0, 11/11/2013 - 11/13/2013; ","0 11596 65047 0, 11/11/2013 - 11/13/2013; ","."," 919,616.31 total pounds, for all products","Garden-Fresh Foods is recalling various cut vegetables, ready-to-eat salads, slaw, spread and dip products sold under various brands and code dates manufactured prior to November 06, 2013 because they may be contaminated with Listeria monocytogenes.",11/7/2013,"11/07/2013",12/26/2013,"12/26/2013"
"Food",66819,"Ongoing","Garden-Fresh Foods, Inc.","Milwaukee","WI","US","Voluntary: Firm Initiated","Press Release","IL, IN, MI, MN, MO, OH, PA, WI.","F-1072-2014","Class I","Garden-Fresh Taffy Apple Salad Kit 1/5 lb. 0 11596 55049 7 11/11/2013 - 11/13/2013 ","0 11596 55049 7 11/11/2013 - 11/13/2013 ","."," 919,616.31 total pounds, for all products","Garden-Fresh Foods is recalling various cut vegetables, ready-to-eat salads, slaw, spread and dip products sold under various brands and code dates manufactured prior to November 06, 2013 because they may be contaminated with Listeria monocytogenes.",11/7/2013,"11/07/2013",12/26/2013,"12/26/2013"
"Food",66819,"Ongoing","Garden-Fresh Foods, Inc.","Milwaukee","WI","US","Voluntary: Firm Initiated","Press Release","IL, IN, MI, MN, MO, OH, PA, WI.","F-0973-2014","Class I","Garden-Fresh, Italian Pasta Salad, 1/8 lb., 0 11596 92012 4, 11/21/2013 - 12/6/2013; Old Tyme, Italian Pasta Salad, 1/8 lb., 0 94776 03412 3, 11/21/2013 - 12/6/2013; ","0 11596 92012 4, 11/21/2013 - 12/6/2013; 0 94776 03412 3, 11/21/2013 - 12/6/2013; ","."," 919,616.31 total pounds, for all products","Garden-Fresh Foods is recalling various cut vegetables, ready-to-eat salads, slaw, spread and dip products sold under various brands and code dates manufactured prior to November 06, 2013 because they may be contaminated with Listeria monocytogenes.",11/7/2013,"11/07/2013",12/26/2013,"12/26/2013"
"Food",66819,"Ongoing","Garden-Fresh Foods, Inc.","Milwaukee","WI","US","Voluntary: Firm Initiated","Press Release","IL, IN, MI, MN, MO, OH, PA, WI.","F-0997-2014","Class I","Garden-Fresh, Parmesan Peppercorn Pasta Salad Base, 1/5 lb.,, 0 11596 52086 5, 11/20/2013 - 12/1/2013; ","0 11596 52086 5, 11/20/2013 - 12/1/2013; ","."," 919,616.31 total pounds, for all products","Garden-Fresh Foods is recalling various cut vegetables, ready-to-eat salads, slaw, spread and dip products sold under various brands and code dates manufactured prior to November 06, 2013 because they may be contaminated with Listeria monocytogenes.",11/7/2013,"11/07/2013",12/26/2013,"12/26/2013"
"Food",66819,"Ongoing","Garden-Fresh Foods, Inc.","Milwaukee","WI","US","Voluntary: Firm Initiated","Press Release","IL, IN, MI, MN, MO, OH, PA, WI.","F-0873-2014","Class I","Finest Traditions, Black Olive Jalapeno Pepper Spread, 2/4 lb., 10 733147 10859 5, 11/25/2013 ","10 733147 10859 5, 11/25/2013 ","."," 919,616.31 total pounds, for all products","Garden-Fresh Foods is recalling various cut vegetables, ready-to-eat salads, slaw, spread and dip products sold under various brands and code dates manufactured prior to November 06, 2013 because they may be contaminated with Listeria monocytogenes.",11/7/2013,"11/07/2013",12/26/2013,"12/26/2013"
"Food",66819,"Ongoing","Garden-Fresh Foods, Inc.","Milwaukee","WI","US","Voluntary: Firm Initiated","Press Release","IL, IN, MI, MN, MO, OH, PA, WI.","F-0965-2014","Class I","Dairy Fresh, Homemade Dixie Cole Slaw,2/5 lb., 0 70163 55890 8, 12/8/2013; ","0 70163 55890 8, 12/8/2013; ","."," 919,616.31 total pounds, for all products","Garden-Fresh Foods is recalling various cut vegetables, ready-to-eat salads, slaw, spread and dip products sold under various brands and code dates manufactured prior to November 06, 2013 because they may be contaminated with Listeria monocytogenes.",11/7/2013,"11/07/2013",12/26/2013,"12/26/2013"
"Food",66819,"Ongoing","Garden-Fresh Foods, Inc.","Milwaukee","WI","US","Voluntary: Firm Initiated","Press Release","IL, IN, MI, MN, MO, OH, PA, WI.","F-0926-2014","Class I","Dairy Fresh, Deluxe BLT Pasta Salad, 1/5 lb., 0 70163 50074 7 ,11/26/2013 - 12/10/2013 Finest Traditions, Deluxe BLT Pasta Salad, 1/8 lb.,10 733147 10770 3, 11/25/2013 - 12/9/2013 ","0 70163 50074 7 ,11/26/2013 - 12/10/2013; 10 733147 10770 3, 11/25/2013 - 12/9/2013 ","."," 919,616.31 total pounds, for all products","Garden-Fresh Foods is recalling various cut vegetables, ready-to-eat salads, slaw, spread and dip products sold under various brands and code dates manufactured prior to November 06, 2013 because they may be contaminated with Listeria monocytogenes.",11/7/2013,"11/07/2013",12/26/2013,"12/26/2013"
"Food",66819,"Ongoing","Garden-Fresh Foods, Inc.","Milwaukee","WI","US","Voluntary: Firm Initiated","Press Release","IL, IN, MI, MN, MO, OH, PA, WI.","F-0978-2014","Class I","Garden-Fresh, Layered Taco Dip Kit, 1/8.125 lb. ,0 11 11596 95162 7, 11/9/2013 - 11/20/2013 ","0 11 11596 95162 7, 11/9/2013 - 11/20/2013 ","."," 919,616.31 total pounds, for all products","Garden-Fresh Foods is recalling various cut vegetables, ready-to-eat salads, slaw, spread and dip products sold under various brands and code dates manufactured prior to November 06, 2013 because they may be contaminated with Listeria monocytogenes.",11/7/2013,"11/07/2013",12/26/2013,"12/26/2013"
"Food",66819,"Ongoing","Garden-Fresh Foods, Inc.","Milwaukee","WI","US","Voluntary: Firm Initiated","Press Release","IL, IN, MI, MN, MO, OH, PA, WI.","F-0987-2014","Class I","Garden-Fresh, Minestrone Salad, 1/5 lb,. 0 11596 52085 8, 11/22/2013 - 12/5/2013 ","0 11596 52085 8, 11/22/2013 - 12/5/2013 ","."," 919,616.31 total pounds, for all products","Garden-Fresh Foods is recalling various cut vegetables, ready-to-eat salads, slaw, spread and dip products sold under various brands and code dates manufactured prior to November 06, 2013 because they may be contaminated with Listeria monocytogenes.",11/7/2013,"11/07/2013",12/26/2013,"12/26/2013"
"Food",66819,"Ongoing","Garden-Fresh Foods, Inc.","Milwaukee","WI","US","Voluntary: Firm Initiated","Press Release","IL, IN, MI, MN, MO, OH, PA, WI.","F-0953-2014","Class I","Finest Traditions, Garden Vegetable Spaghetti Salad, 1/8 lb., 10 733147 10196 1, 11/25/2013 - 12/9/2013 ;","10 733147 10196 1, 11/25/2013 - 12/9/2013 ","."," 919,616.31 total pounds, for all products","Garden-Fresh Foods is recalling various cut vegetables, ready-to-eat salads, slaw, spread and dip products sold under various brands and code dates manufactured prior to November 06, 2013 because they may be contaminated with Listeria monocytogenes.",11/7/2013,"11/07/2013",12/26/2013,"12/26/2013"
"Food",66819,"Ongoing","Garden-Fresh Foods, Inc.","Milwaukee","WI","US","Voluntary: Firm Initiated","Press Release","IL, IN, MI, MN, MO, OH, PA, WI.","F-0944-2014","Class II","Grandpa's, Fresh Salsa, 1/5 lb., 0 11596 55912 4, 12/1/2013 - 12/12/2013; Grandpa's, Fresh Salsa, 4/5 lb., 0 11596 55913 1, 12/1/2013 - 12/12/2013; Our Own, Fresh Salsa , 1/5 lb., 0 11596 59021 9 , 11/22/213 - 12/9/2013 ;","0 11596 55912 4 12/1/2013 - 12/12/2013; 0 11596 55913 1 12/1/2013 - 12/12/2013; 0 11596 59021 9 11/22/213 - 12/9/2013 ;","."," 919,616.31 total pounds, for all products","Garden-Fresh Foods is recalling various cut vegetables, ready-to-eat salads, slaw, spread and dip products sold under various brands and code dates manufactured prior to November 06, 2013 because they may be contaminated with Listeria monocytogenes.",11/7/2013,"11/07/2013",12/26/2013,"12/26/2013"
"Food",66819,"Ongoing","Garden-Fresh Foods, Inc.","Milwaukee","WI","US","Voluntary: Firm Initiated","Press Release","IL, IN, MI, MN, MO, OH, PA, WI.","F-1048-2014","Class I","Garden-Fresh, Soup Mix 3/4''., 2/5 lb,.. 0 11596 50763 7, 10/31/2103 - 11/8/2013; ","0 11596 50763 7, 10/31/2103 - 11/8/2013; ","."," 919,616.31 total pounds, for all products","Garden-Fresh Foods is recalling various cut vegetables, ready-to-eat salads, slaw, spread and dip products sold under various brands and code dates manufactured prior to November 06, 2013 because they may be contaminated with Listeria monocytogenes.",11/7/2013,"11/07/2013",12/26/2013,"12/26/2013"
"Food",66819,"Ongoing","Garden-Fresh Foods, Inc.","Milwaukee","WI","US","Voluntary: Firm Initiated","Press Release","IL, IN, MI, MN, MO, OH, PA, WI.","F-0989-2014","Class I","Finest Traditions, Mock Crab Salad, 6/16 oz., 7 33147 00027 4, 10 733147 10001 8, 11/20/2013 - 12/9/2013; Finest Traditions, Mock Crab Salad, 1/8 lb., 10 733147 10287 6, 11/20/2013 - 12/9/2013; ","7 33147 00027 4, 10 733147 10001 8, 11/20/2013 - 12/9/2013; 10 733147 10287 6, 11/20/2013 - 12/9/2013; ","."," 919,616.31 total pounds, for all products","Garden-Fresh Foods is recalling various cut vegetables, ready-to-eat salads, slaw, spread and dip products sold under various brands and code dates manufactured prior to November 06, 2013 because they may be contaminated with Listeria monocytogenes.",11/7/2013,"11/07/2013",12/26/2013,"12/26/2013"
"Food",66819,"Ongoing","Garden-Fresh Foods, Inc.","Milwaukee","WI","US","Voluntary: Firm Initiated","Press Release","IL, IN, MI, MN, MO, OH, PA, WI.","F-0931-2014","Class I","Finest Traditions, Dill Dip, 1/8 lb., 10 733147 10122 0 11/20/2013 - 12/9/2013; Finest Traditions, Dill Dip, 6/8 oz., 7 33147 10554 2, 10 733147 10555 9, 11/27/2013 - 12/11/2013; Roundy's, Dill Dip, 6/12 oz., 0 11150 52603 6, 0 00 11150 52603 6, 12/16/2013 - 12/24/2013; Spoon River, Dill Dip, 1/5 lb., 0 11596 55680 2, 12/16/2013 - 12/30/2013; "," 10 733147 10122 0 11/20/2013 - 12/9/2013; 7 33147 10554 2 10 733147 10555 9 11/27/2013 - 12/11/2013; 0 11150 52603 6 0 00 11150 52603 6 12/16/2013 - 12/24/2013; 0 11596 55680 2 12/16/2013 - 12/30/2013; ","."," 919,616.31 total pounds, for all products","Garden-Fresh Foods is recalling various cut vegetables, ready-to-eat salads, slaw, spread and dip products sold under various brands and code dates manufactured prior to November 06, 2013 because they may be contaminated with Listeria monocytogenes.",11/7/2013,"11/07/2013",12/26/2013,"12/26/2013"
"Food",66819,"Ongoing","Garden-Fresh Foods, Inc.","Milwaukee","WI","US","Voluntary: Firm Initiated","Press Release","IL, IN, MI, MN, MO, OH, PA, WI.","F-0891-2014","Class I","Garden-Fresh, Carrot Shredded 1/8'' 4/5 lb., 0 11596 50274 8, 10/28/2013 - 11/6/2013; Wong's Wok, Carrot Shredded 3'', 1/5 lb., 0 11596 00270 5, 10/29/2013; Garden-Fresh, Carrot Sticks,2/5 lb. , 0 11596 50259 5, 11/4/2013; Garden-Fresh,Carrot Sticks 3.5'' , 1/5 lb., 0 11596 50260 1, 10/28/2013 - 11/6/2013; Garden-Fresh, Carrots Diced 1/4'', 1/5 lb. , 11596 50252 6, 10/30/2013 - 11/5/2013; Garden-Fresh, Carrots Diced 1/4'', 1/10 lb., 0 11596 50253 3, 11/5/2013; Vanee, Carrots diced 3/4 x 3/4 x 3/4, 1/25 lb , 11/11/2013; Garden-Fresh, Carrots Shredded 1/8'', 1/5 lb., 0 11596 50270 0, 10/28/2013 ","0 11596 50274 8, 10/28/2013 - 11/6/2013; 0 11596 00270 5, 10/29/2013; 0 11596 50259 5, 11/4/2013; 0 11596 50260 1, 10/28/2013 - 11/6/2013; 11596 50252 6, 10/30/2013 - 11/5/2013; 0 11596 50253 3, 11/5/2013; 11/11/2013; 0 11596 50270 0, 10/28/2013 ","."," 919,616.31 total pounds, for all products","Garden-Fresh Foods is recalling various cut vegetables, ready-to-eat salads, slaw, spread and dip products sold under various brands and code dates manufactured prior to November 06, 2013 because they may be contaminated with Listeria monocytogenes.",11/7/2013,"11/07/2013",12/26/2013,"12/26/2013"
"Food",66819,"Ongoing","Garden-Fresh Foods, Inc.","Milwaukee","WI","US","Voluntary: Firm Initiated","Press Release","IL, IN, MI, MN, MO, OH, PA, WI.","F-0995-2014","Class I","Weis, Original Potato Salad, 12/16 oz., 0 41497 05838 9, 0 00 41497 05838 9, 11/25/2013- 11/28/2013; Weis, Original Potato Salad, 4/3 lb., 0 41497 05900 3, 0 00 41497 05900 3, 11/21/2013; Weis, Original Potato Salad, 2/5 lb., 0 11596 51102 3, 11/21/2013 - 12/2/2013; ","0 41497 05838 9, 0 00 41497 05838 9, 11/25/2013- 11/28/2013; 0 41497 05900 3, 0 00 41497 05900 3, 11/21/2013; 0 11596 51102 3, 11/21/2013 - 12/2/2013; ","."," 919,616.31 total pounds, for all products","Garden-Fresh Foods is recalling various cut vegetables, ready-to-eat salads, slaw, spread and dip products sold under various brands and code dates manufactured prior to November 06, 2013 because they may be contaminated with Listeria monocytogenes.",11/7/2013,"11/07/2013",12/26/2013,"12/26/2013"
"Food",66819,"Ongoing","Garden-Fresh Foods, Inc.","Milwaukee","WI","US","Voluntary: Firm Initiated","Press Release","IL, IN, MI, MN, MO, OH, PA, WI.","F-0913-2014","Class I","Garden-Fresh, Cranberry Ambrosia , 2/5 lb.,0 11596 55091 6, 11/25/2013 - 12/10/2013 ","0 11596 55091 6, 11/25/2013 - 12/10/2013 ","."," 919,616.31 total pounds, for all products","Garden-Fresh Foods is recalling various cut vegetables, ready-to-eat salads, slaw, spread and dip products sold under various brands and code dates manufactured prior to November 06, 2013 because they may be contaminated with Listeria monocytogenes.",11/7/2013,"11/07/2013",12/26/2013,"12/26/2013"
"Food",66819,"Ongoing","Garden-Fresh Foods, Inc.","Milwaukee","WI","US","Voluntary: Firm Initiated","Press Release","IL, IN, MI, MN, MO, OH, PA, WI.","F-0959-2014","Class I","Garden-Fresh, Greek Salad Kit, 1/2.5 lb., 0 11596 30178 5, 11/9/2013 - 11/14/2013 ","0 11596 30178 5, 11/9/2013 - 11/14/2013 ","."," 919,616.31 total pounds, for all products","Garden-Fresh Foods is recalling various cut vegetables, ready-to-eat salads, slaw, spread and dip products sold under various brands and code dates manufactured prior to November 06, 2013 because they may be contaminated with Listeria monocytogenes.",11/7/2013,"11/07/2013",12/26/2013,"12/26/2013"
"Food",66819,"Ongoing","Garden-Fresh Foods, Inc.","Milwaukee","WI","US","Voluntary: Firm Initiated","Press Release","IL, IN, MI, MN, MO, OH, PA, WI.","F-1073-2014","Class I","Garden-Fresh, Texa Style BBQ Beans, 1/5 lb., 0 11596 55131 9, 11/25/2013 - 12/10/2013; ","0 11596 55131 9, 11/25/2013 - 12/10/2013; ","."," 919,616.31 total pounds, for all products","Garden-Fresh Foods is recalling various cut vegetables, ready-to-eat salads, slaw, spread and dip products sold under various brands and code dates manufactured prior to November 06, 2013 because they may be contaminated with Listeria monocytogenes.",11/7/2013,"11/07/2013",12/26/2013,"12/26/2013"
"Food",66819,"Ongoing","Garden-Fresh Foods, Inc.","Milwaukee","WI","US","Voluntary: Firm Initiated","Press Release","IL, IN, MI, MN, MO, OH, PA, WI.","F-0894-2014","Class I","Finest Traditions, Cheddar Cheese & Olive Spread, 2/4 lb., 10 733147 10860 1, 11/25/2013 ","10 733147 10860 1, 11/25/2013 ","."," 919,616.31 total pounds, for all products","Garden-Fresh Foods is recalling various cut vegetables, ready-to-eat salads, slaw, spread and dip products sold under various brands and code dates manufactured prior to November 06, 2013 because they may be contaminated with Listeria monocytogenes.",11/7/2013,"11/07/2013",12/26/2013,"12/26/2013"
"Food",66819,"Ongoing","Garden-Fresh Foods, Inc.","Milwaukee","WI","US","Voluntary: Firm Initiated","Press Release","IL, IN, MI, MN, MO, OH, PA, WI.","F-0889-2014","Class I","Garden-Fresh, California Pasta Salad, 2/5 lb., 0 11596 82068 2 11/10/2013 - 11/20/2013 "," 0 11596 82068 2 11/10/2013 - 11/20/2013 ","."," 919,616.31 total pounds, for all products","Garden-Fresh Foods is recalling various cut vegetables, ready-to-eat salads, slaw, spread and dip products sold under various brands and code dates manufactured prior to November 06, 2013 because they may be contaminated with Listeria monocytogenes.",11/7/2013,"11/07/2013",12/26/2013,"12/26/2013"
"Food",66819,"Ongoing","Garden-Fresh Foods, Inc.","Milwaukee","WI","US","Voluntary: Firm Initiated","Press Release","IL, IN, MI, MN, MO, OH, PA, WI.","F-0888-2014","Class I","Garden-Fresh, Calico Beans, 4/5 lb. , 0 11596 52500 6, 11/22/2013 - 12/2/2013; Garden-Fresh, Calico Beans, 1/5 lb. , 0 11596 52596 9, 11/11/2013 - 12/2/2013; "," 11596 52500 6, 11/22/2013 - 12/2/2013; 0 11596 52596 9, 11/11/2013 - 12/2/2013; ","."," 919,616.31 total pounds, for all products","Garden-Fresh Foods is recalling various cut vegetables, ready-to-eat salads, slaw, spread and dip products sold under various brands and code dates manufactured prior to November 06, 2013 because they may be contaminated with Listeria monocytogenes.",11/7/2013,"11/07/2013",12/26/2013,"12/26/2013"
"Food",66819,"Ongoing","Garden-Fresh Foods, Inc.","Milwaukee","WI","US","Voluntary: Firm Initiated","Press Release","IL, IN, MI, MN, MO, OH, PA, WI.","F-1069-2014","Class I","Finest Traditions, Taco Dip, 6/8 oz., 7 33147 10556 6, 10 733147 10557 0, 11/27/2013 - 12/9/2013 Grandpa's, Taco Dip, 1/5 lb., 0 11596 55903 2, 12/16/2013 - 12/31/2013 Maggie's, Taco Dip, 6/12 oz., 0 11596 06201 3, 0 00 11596 06201 3, 12/20/2013 - 12/30/2013 Roundy's, Taco Dip, 6/12 oz., 0 11150 52604 3, 0 00 11150 52604 3, 12/16/2013 - 12/24/2013 ","7 33147 10556 6 10 733147 10557 0 11/27/2013 - 12/9/2013; 0 11596 55903 2 12/16/2013 - 12/31/2013; 0 11596 06201 3 0 00 11596 06201 3 12/20/2013 - 12/30/2013; 0 11150 52604 3 0 00 11150 52604 3 12/16/2013 - 12/24/2013; ","."," 919,616.31 total pounds, for all products","Garden-Fresh Foods is recalling various cut vegetables, ready-to-eat salads, slaw, spread and dip products sold under various brands and code dates manufactured prior to November 06, 2013 because they may be contaminated with Listeria monocytogenes.",11/7/2013,"11/07/2013",12/26/2013,"12/26/2013"
"Food",66819,"Ongoing","Garden-Fresh Foods, Inc.","Milwaukee","WI","US","Voluntary: Firm Initiated","Press Release","IL, IN, MI, MN, MO, OH, PA, WI.","F-0928-2014","Class I","Finest Traditions, Deluxe Potato Salad, 4/8 lb.,10 733147 10450 4, 11/20/2013 - 12/9/2013; Finest Traditions, Deluxe Potato Salad, 1/8 lb., 10 733147 10130 5, 11/20/2013 - 12/9/2013; Finest Traditions, Deluxe Potato Salad, 6/16 oz., 7 33147 00007 6,10 733147 10133 6, 11/27/2013 - 12/11/2013; ","10 733147 10450 4 11/20/2013 - 12/9/2013; 10 733147 10130 5 11/20/2013 - 12/9/2013; 10 733147 10133 6 11/27/2013 - 12/11/2013; ","."," 919,616.31 total pounds, for all products","Garden-Fresh Foods is recalling various cut vegetables, ready-to-eat salads, slaw, spread and dip products sold under various brands and code dates manufactured prior to November 06, 2013 because they may be contaminated with Listeria monocytogenes.",11/7/2013,"11/07/2013",12/26/2013,"12/26/2013"
"Food",66819,"Ongoing","Garden-Fresh Foods, Inc.","Milwaukee","WI","US","Voluntary: Firm Initiated","Press Release","IL, IN, MI, MN, MO, OH, PA, WI.","F-0892-2014","Class I","Garden-Fresh, Celery Diced 1/2'', 2/5 lb., 0 11596 50211 3, 11/1/2103; Garden-Fresh, Celery Diced 1/4'', 1/2.5 lb., 0 11596 50202 1, 10/31/2013; Garden-Fresh, Celery Diced 1/4'', 2/5 lb., 0 11596 50206 9, 11/13/2013; Garden-Fresh, Celery Diced 3/8'', 2/5 lb., 0 11596 02081 5, 10/28/2013 - 10/30/2013; Wong's Wok, Celery Diced 5/8'', 2/10 lb., 0 11596 50200 7 , 10/31/2013; Garden-Fresh, Celery Sliced 1/4'', 1/5 lb.,, 0 11596 50215 1, 11/1/2103; Garden-Fresh, Celery Sticks, 2/5 lb., 0 11596 50209 0, 10/28/2013 - 11/4/2013; Garden-Fresh, Celery Sticks , 1/5 lb., 0 11596 50210 6, 11/1/2103 - 11/9/2013; ","0 11596 50211 3 11/1/2103; 0 11596 50202 1 10/31/2013; 0 11596 50206 9 11/13/2013; 0 11596 02081 5 10/28/2013 - 10/30/2013; 0 11596 50200 7 10/31/2013; 0 11596 50215 1 11/1/2103; 0 11596 50209 0 10/28/2013 - 11/4/2013; 0 11596 50210 6 11/1/2103 - 11/9/2013; ","."," 919,616.31 total pounds, for all products","Garden-Fresh Foods is recalling various cut vegetables, ready-to-eat salads, slaw, spread and dip products sold under various brands and code dates manufactured prior to November 06, 2013 because they may be contaminated with Listeria monocytogenes.",11/7/2013,"11/07/2013",12/26/2013,"12/26/2013"
"Food",66819,"Ongoing","Garden-Fresh Foods, Inc.","Milwaukee","WI","US","Voluntary: Firm Initiated","Press Release","IL, IN, MI, MN, MO, OH, PA, WI.","F-0998-2014","Class I","Dairy Fresh, Pasta & Tomato Salad, 1/5 lb,. 0 70163 41000 8, 11/26/2013 - 12/3/2013; ","0 70163 41000 8, 11/26/2013 - 12/3/2013; ","."," 919,616.31 total pounds, for all products","Garden-Fresh Foods is recalling various cut vegetables, ready-to-eat salads, slaw, spread and dip products sold under various brands and code dates manufactured prior to November 06, 2013 because they may be contaminated with Listeria monocytogenes.",11/7/2013,"11/07/2013",12/26/2013,"12/26/2013"
"Food",66819,"Ongoing","Garden-Fresh Foods, Inc.","Milwaukee","WI","US","Voluntary: Firm Initiated","Press Release","IL, IN, MI, MN, MO, OH, PA, WI.","F-0861-2014","Class I","Dairy Fresh, Asian Vegetable Orzo, 1/5 lb., 0 70163 50242 0, 11/26/2013 - 12/10/2013; Finest Traditions, Asian Vegetable Orzo, 1/5 lb., 10 733147 10976 9 12/2/2013 - 12/9/2013; Garden-Fresh, Asian Vegetable Orzo, 1/5 lb., 0 11596 52073 5 11/28/2013 - 12/6/2013; ","0 70163 50242 0 = 11/26/2013 - 12/10/2013; 10 733147 10976 9 = 12/2/2013 - 12/9/2013; 0 11596 52073 5 = 11/28/2013 - 12/6/2013; ","."," 919,616.31 total pounds, for all products","Garden-Fresh Foods is recalling various cut vegetables, ready-to-eat salads, slaw, spread and dip products sold under various brands and code dates manufactured prior to November 06, 2013 because they may be contaminated with Listeria monocytogenes.",11/7/2013,"11/07/2013",12/26/2013,"12/26/2013"
"Food",66819,"Ongoing","Garden-Fresh Foods, Inc.","Milwaukee","WI","US","Voluntary: Firm Initiated","Press Release","IL, IN, MI, MN, MO, OH, PA, WI.","F-0933-2014","Class I","Garden-Fresh, Egg Salad, 1/5 lb. 0 11596 52022 ,11/17/2013 - 12/5/2013; Weis, Egg Salad, 9/8 oz., 0 41497 05365 0, 0 00 41497 05365 0,11/20/2013; Weis, Egg Salad, 1/5 lb., 0 11596 55221 7, 11/16/2013 - 11/28/2013; ;","0 11596 52022 3 11/17/2013 - 12/5/2013; 0 00 41497 05365 0 11/20/2013; 0 11596 55221 7 11/16/2013 - 11/28/2013; ","."," 919,616.31 total pounds, for all products","Garden-Fresh Foods is recalling various cut vegetables, ready-to-eat salads, slaw, spread and dip products sold under various brands and code dates manufactured prior to November 06, 2013 because they may be contaminated with Listeria monocytogenes.",11/7/2013,"11/07/2013",12/26/2013,"12/26/2013"
"Food",66819,"Ongoing","Garden-Fresh Foods, Inc.","Milwaukee","WI","US","Voluntary: Firm Initiated","Press Release","IL, IN, MI, MN, MO, OH, PA, WI.","F-1010-2014","Class I","Garden-Fresh, Potatoes 1/2x1/2x1/2, Diced, 1/30 lb., 0 11596 90415 3, 11/1/2013 - 11/5/2013; Garden-Fresh, Potatoes 1/2x1/2x1/2 Diced, 1/15 lb., 0 11596 00415 0, 11/1/2013 - 11/5/2013; Garden-Fresh, Potatoes 3/4 x 3/4 x 3/4 Diced, 1/30 lb., 11/1/2013 - 11/5/2013; Vanee, Potatoes 3/8x3/8x3/8 Diced White, 1/30 lb., 0 11596 90453 5, 11/11/2013; Garden-Fresh, Potatoes Whole Peeled A, 1/30 lb., 0 11596 90405 4, 11/1/2013 - 11/5/2013 ;","0 11596 90415 3 11/1/2013 - 11/5/2013; 0 11596 00415 0 11/1/2013 - 11/5/2013; 11/1/2013 - 11/5/2013; 0 11596 90453 5 11/11/2013; 0 11596 90405 4 11/1/2013 - 11/5/2013; ","."," 919,616.31 total pounds, for all products","Garden-Fresh Foods is recalling various cut vegetables, ready-to-eat salads, slaw, spread and dip products sold under various brands and code dates manufactured prior to November 06, 2013 because they may be contaminated with Listeria monocytogenes.",11/7/2013,"11/07/2013",12/26/2013,"12/26/2013"
"Food",66819,"Ongoing","Garden-Fresh Foods, Inc.","Milwaukee","WI","US","Voluntary: Firm Initiated","Press Release","IL, IN, MI, MN, MO, OH, PA, WI.","F-1022-2014","Class I","Garden-Fresh, Red Potato & Herb Salad, 2/5 lb., 0 11596 91014 7, 11/21/2013 - 12/10/2013; ","0 11596 91014 7, 11/21/2013 - 12/10/2013; ","."," 919,616.31 total pounds, for all products","Garden-Fresh Foods is recalling various cut vegetables, ready-to-eat salads, slaw, spread and dip products sold under various brands and code dates manufactured prior to November 06, 2013 because they may be contaminated with Listeria monocytogenes.",11/7/2013,"11/07/2013",12/26/2013,"12/26/2013"
"Food",66819,"Ongoing","Garden-Fresh Foods, Inc.","Milwaukee","WI","US","Voluntary: Firm Initiated","Press Release","IL, IN, MI, MN, MO, OH, PA, WI.","F-0958-2014","Class I","Marsh, Grandpa's Cole Slaw, 2/5 lb., 0 11596 93021 3, 11/17/2013 - 12/1/2013 ","0 11596 93021 3, 11/17/2013 - 12/1/2013 ","."," 919,616.31 total pounds, for all products","Garden-Fresh Foods is recalling various cut vegetables, ready-to-eat salads, slaw, spread and dip products sold under various brands and code dates manufactured prior to November 06, 2013 because they may be contaminated with Listeria monocytogenes.",11/7/2013,"11/07/2013",12/26/2013,"12/26/2013"
"Food",66819,"Ongoing","Garden-Fresh Foods, Inc.","Milwaukee","WI","US","Voluntary: Firm Initiated","Press Release","IL, IN, MI, MN, MO, OH, PA, WI.","F-1047-2014","Class I","Finest Traditions, Smoky Baked Beans, 4/8 lb., 10 733147 10456 6, 11/25/2013 - 12/9/2013; Finest Traditions, Smoky Baked Beans, 6/16 oz., 7 33147 00161 5, 10 733147 10243 2, 11/28/2013 - 12/9/2013; Finest Traditions, Smoky Baked Beans, 6/16 oz., 7 33147 00161 5, 10 733147 10243 2, 11/20/2013 - 12/9/2013; ","10 733147 10456 6, 11/25/2013 - 12/9/2013; 7 33147 00161 5, 10 733147 10243 2, 11/28/2013 - 12/9/2013; 7 33147 00161 5, 10 733147 10243 2, 11/20/2013 - 12/9/2013; ","."," 919,616.31 total pounds, for all products","Garden-Fresh Foods is recalling various cut vegetables, ready-to-eat salads, slaw, spread and dip products sold under various brands and code dates manufactured prior to November 06, 2013 because they may be contaminated with Listeria monocytogenes.",11/7/2013,"11/07/2013",12/26/2013,"12/26/2013"
"Food",66819,"Ongoing","Garden-Fresh Foods, Inc.","Milwaukee","WI","US","Voluntary: Firm Initiated","Press Release","IL, IN, MI, MN, MO, OH, PA, WI.","F-0884-2014","Class I","Garden-Fresh, Cabbage Chopped, 1/5 lb., 0 11596 50107 9, 10/30/2013 - 11/6/2013; Garden-Fresh, Cabbage Chopped, 4/5 lb., 0 11596 50108 6 , 10/28/2013 - 11/5/2013; Garden-Fresh, Cabbage Chopped 3/4'', 4/5 lb., 0 11596 50115 4 11/1/2013 ; "," 0 11596 50107 9, 10/30/2013 - 11/6/2013; 0 11596 50108 6 , 10/28/2013 - 11/5/2013; 0 11596 50115 4 11/1/2013 ; ","."," 919,616.31 total pounds, for all products","Garden-Fresh Foods is recalling various cut vegetables, ready-to-eat salads, slaw, spread and dip products sold under various brands and code dates manufactured prior to November 06, 2013 because they may be contaminated with Listeria monocytogenes.",11/7/2013,"11/07/2013",12/26/2013,"12/26/2013"
"Food",66819,"Ongoing","Garden-Fresh Foods, Inc.","Milwaukee","WI","US","Voluntary: Firm Initiated","Press Release","IL, IN, MI, MN, MO, OH, PA, WI.","F-1095-2014","Class I","Garden-Fresh, Whole Grain Penne with Spinach, Tomato & Feta, 1/5 lb,. 0 11596 52063 6, 11/26/2013 - 12/6/2013; ","0 11596 52063 6, 11/26/2013 - 12/6/2013; ","."," 919,616.31 total pounds, for all products","Garden-Fresh Foods is recalling various cut vegetables, ready-to-eat salads, slaw, spread and dip products sold under various brands and code dates manufactured prior to November 06, 2013 because they may be contaminated with Listeria monocytogenes.",11/7/2013,"11/07/2013",12/26/2013,"12/26/2013"
"Food",66819,"Ongoing","Garden-Fresh Foods, Inc.","Milwaukee","WI","US","Voluntary: Firm Initiated","Press Release","IL, IN, MI, MN, MO, OH, PA, WI.","F-0860-2014","Class I","Dairy Fresh, Asiago Pasta Salad, 1/5 lb.,0 70163 50041 9, 11/26/2013; Garden-Fresh, Asiago Pasta Salad, 2/5 lb., 0 11596 52069 8, 11/21/2013 - 12/10/2013 ","0 70163 50041 9 = 11/26/2013; 0 11596 52069 8 = 11/21/2013 - 12/10/2013 ","."," 919,616.31 total pounds, for all products","Garden-Fresh Foods is recalling various cut vegetables, ready-to-eat salads, slaw, spread and dip products sold under various brands and code dates manufactured prior to November 06, 2013 because they may be contaminated with Listeria monocytogenes.",11/7/2013,"11/07/2013",12/26/2013,"12/26/2013"
"Food",66819,"Ongoing","Garden-Fresh Foods, Inc.","Milwaukee","WI","US","Voluntary: Firm Initiated","Press Release","IL, IN, MI, MN, MO, OH, PA, WI.","F-1015-2014","Class I","Garden-Fresh, Pumpkin Bread Pudding, 1/7 lb., 0 11596 75036 1, 11/21/2013 - 12/10/2013 Garden-Fresh, Pumpkin Bread Pudding, 6/12 oz., 0 11596 07036 0, 0 11596 07036 0, 11/27/2013 - 12/7/2013 ","0 11596 75036 1, 11/21/2013 - 12/10/2013; 0 11596 07036 0, 0 11596 07036 0, 11/27/2013 - 12/7/2013 ","."," 919,616.31 total pounds, for all products","Garden-Fresh Foods is recalling various cut vegetables, ready-to-eat salads, slaw, spread and dip products sold under various brands and code dates manufactured prior to November 06, 2013 because they may be contaminated with Listeria monocytogenes.",11/7/2013,"11/07/2013",12/26/2013,"12/26/2013"
"Food",66819,"Ongoing","Garden-Fresh Foods, Inc.","Milwaukee","WI","US","Voluntary: Firm Initiated","Press Release","IL, IN, MI, MN, MO, OH, PA, WI.","F-0961-2014","Class I","Our Own, Greek Village Salad, 1/5 lb., 0 11596 52151 0, 11/30/2013 - 12/4/2013 ","0 11596 52151 0, 11/30/2013 - 12/4/2013 ","."," 919,616.31 total pounds, for all products","Garden-Fresh Foods is recalling various cut vegetables, ready-to-eat salads, slaw, spread and dip products sold under various brands and code dates manufactured prior to November 06, 2013 because they may be contaminated with Listeria monocytogenes.",11/7/2013,"11/07/2013",12/26/2013,"12/26/2013"
"Food",66819,"Ongoing","Garden-Fresh Foods, Inc.","Milwaukee","WI","US","Voluntary: Firm Initiated","Press Release","IL, IN, MI, MN, MO, OH, PA, WI.","F-0966-2014","Class I","Dairy Fresh, Homemade Macaroni Salad, 2/5 lb., 0 70163 89080 0 12/8/2013; ;","0 70163 89080 0 12/8/2013; ","."," 919,616.31 total pounds, for all products","Garden-Fresh Foods is recalling various cut vegetables, ready-to-eat salads, slaw, spread and dip products sold under various brands and code dates manufactured prior to November 06, 2013 because they may be contaminated with Listeria monocytogenes.",11/7/2013,"11/07/2013",12/26/2013,"12/26/2013"
"Food",66819,"Ongoing","Garden-Fresh Foods, Inc.","Milwaukee","WI","US","Voluntary: Firm Initiated","Press Release","IL, IN, MI, MN, MO, OH, PA, WI.","F-1029-2014","Class I","Grandpa's, Roasted Corn & Black Bean Salsa, 1/5 lb., 0 11596 55915 5, 11/29/2013 - 12/2/2013; ","0 11596 55915 5, 11/29/2013 - 12/2/2013; ; ","."," 919,616.31 total pounds, for all products","Garden-Fresh Foods is recalling various cut vegetables, ready-to-eat salads, slaw, spread and dip products sold under various brands and code dates manufactured prior to November 06, 2013 because they may be contaminated with Listeria monocytogenes.",11/7/2013,"11/07/2013",12/26/2013,"12/26/2013"
"Food",66819,"Ongoing","Garden-Fresh Foods, Inc.","Milwaukee","WI","US","Voluntary: Firm Initiated","Press Release","IL, IN, MI, MN, MO, OH, PA, WI.","F-0990-2014","Class I","Dairy Fresh, Mustard Potato Salad, 2/5 lb., 0 70163 89090 9, 12/3/2013 - 12/10/2013; Garden-Fresh, Mustard Potato Salad, 2/5 lb., 0 11596 51013 2, 11/26/2013 - 12/7/2013; Garden-Fresh, Mustard Potato Salad, 12/16 oz., 0 11596 14010 0, 0 11596 14010 0, 11/21/2013- 12/9/2013; Garden-Fresh, Mustard Potato Salad, 8/32 oz., 0 11596 24215 6, 0 11596 24215 6 11/25/2013 - 12/7/2013; Garden-Fresh, Mustard Potato Salad, 6/48 oz., 0 11596 34313 6, 0 11596 34313 6 11/21/2013 - 12/10/2013; Rogge's, Mustard Potato Salad, 2/5 lb., 0 11596 51053 8, 11/17/2013 - 12/4/2013; Spartan, Mustard Potato Salad,6/16 oz., 0 11213 90319 4, 0 00 11213 90319 4, 11/26/2013 - 12/2/2013; /2013 - 12/9/2013; "," 0 70163 89090 9 12/3/2013 - 12/10/2013; 0 11596 51013 2 11/26/2013 - 12/7/2013; 0 11596 14010 0 0 11596 14010 0 11/21/2013- 12/9/2013; 0 11596 24215 6 0 11596 24215 6 11/25/2013 - 12/7/2013; 0 11596 34313 6 0 11596 34313 6 11/21/2013 - 12/10/2013; 0 11596 51053 8 11/17/2013 - 12/4/2013; 0 11213 90319 4 0 00 11213 90319 4 11/26/2013 - 12/2/2013; ;","."," 919,616.31 total pounds, for all products","Garden-Fresh Foods is recalling various cut vegetables, ready-to-eat salads, slaw, spread and dip products sold under various brands and code dates manufactured prior to November 06, 2013 because they may be contaminated with Listeria monocytogenes.",11/7/2013,"11/07/2013",12/26/2013,"12/26/2013"
"Food",66819,"Ongoing","Garden-Fresh Foods, Inc.","Milwaukee","WI","US","Voluntary: Firm Initiated","Press Release","IL, IN, MI, MN, MO, OH, PA, WI.","F-1075-2014","Class I","Garden-Fresh, Tomato Mozzarella Kit, 1/5 lb., 0 11596 55163 0, 11/11/2013 - 11/26/2013; ","0 11596 55163 0, 11/11/2013 - 11/26/2013; ","."," 919,616.31 total pounds, for all products","Garden-Fresh Foods is recalling various cut vegetables, ready-to-eat salads, slaw, spread and dip products sold under various brands and code dates manufactured prior to November 06, 2013 because they may be contaminated with Listeria monocytogenes.",11/7/2013,"11/07/2013",12/26/2013,"12/26/2013"
"Food",66819,"Ongoing","Garden-Fresh Foods, Inc.","Milwaukee","WI","US","Voluntary: Firm Initiated","Press Release","IL, IN, MI, MN, MO, OH, PA, WI.","F-1094-2014","Class I","Garden-Fresh, Whole Grain Garden Pepper Pasta, 1/5 lb., 0 11596 52207 4, 11/26/2013 - 11/29/2013; ","0 11596 52207 4, 11/26/2013 - 11/29/2013; ","."," 919,616.31 total pounds, for all products","Garden-Fresh Foods is recalling various cut vegetables, ready-to-eat salads, slaw, spread and dip products sold under various brands and code dates manufactured prior to November 06, 2013 because they may be contaminated with Listeria monocytogenes.",11/7/2013,"11/07/2013",12/26/2013,"12/26/2013"
"Food",66819,"Ongoing","Garden-Fresh Foods, Inc.","Milwaukee","WI","US","Voluntary: Firm Initiated","Press Release","IL, IN, MI, MN, MO, OH, PA, WI.","F-0974-2014","Class I","Garden-Fresh, Kidney Bean Salad, 2/5 lb., 0 11596 52016 2, 11/21/2013 - 12/4/2013; ","0 11596 52016 2, 11/21/2013 - 12/4/2013; ","."," 919,616.31 total pounds, for all products","Garden-Fresh Foods is recalling various cut vegetables, ready-to-eat salads, slaw, spread and dip products sold under various brands and code dates manufactured prior to November 06, 2013 because they may be contaminated with Listeria monocytogenes.",11/7/2013,"11/07/2013",12/26/2013,"12/26/2013"
"Food",66819,"Ongoing","Garden-Fresh Foods, Inc.","Milwaukee","WI","US","Voluntary: Firm Initiated","Press Release","IL, IN, MI, MN, MO, OH, PA, WI.","F-1098-2014","Class I","Garden-Fresh, Wisconsin Cheddar & Pea Salad, 1/5 lb., 0 11596 52021 6, 11/17/2013 - 12/1/2013; ","0 11596 52021 6, 11/17/2013 - 12/1/2013; ","."," 919,616.31 total pounds, for all products","Garden-Fresh Foods is recalling various cut vegetables, ready-to-eat salads, slaw, spread and dip products sold under various brands and code dates manufactured prior to November 06, 2013 because they may be contaminated with Listeria monocytogenes.",11/7/2013,"11/07/2013",12/26/2013,"12/26/2013"
"Food",66819,"Ongoing","Garden-Fresh Foods, Inc.","Milwaukee","WI","US","Voluntary: Firm Initiated","Press Release","IL, IN, MI, MN, MO, OH, PA, WI.","F-0971-2014","Class I","Finest Traditions, Homestyle Potato Salad, 1/8 lb., 10 733147 10134 3, 11/20/2013 - 12/11/2013; Finest Traditions, Homestyle Potato Salad, 4/8 lb., 10 733147 10452 8, 11/20/2013 - 12/9/2013; Finest Traditions, Homestyle Potato Salad, 6/16 oz., 7 33147 00019 9, 10 733147 10175 6, 11/27/2013 - 12/11/2013; Our Own, Homestyle Potato Salad, 4/5 lb., 0 11596 51042 2, 0 00 11596 51042 2, 11/16/2013 - 12/5/2013; ","10 733147 10134 3 11/20/2013 - 12/11/2013; 10 733147 10452 8 11/20/2013 - 12/9/2013; 10 733147 10175 6 11/27/2013 - 12/11/2013; 0 00 11596 51042 2 11/16/2013 - 12/5/2013; ","."," 919,616.31 total pounds, for all products","Garden-Fresh Foods is recalling various cut vegetables, ready-to-eat salads, slaw, spread and dip products sold under various brands and code dates manufactured prior to November 06, 2013 because they may be contaminated with Listeria monocytogenes.",11/7/2013,"11/07/2013",12/26/2013,"12/26/2013"
"Food",66819,"Ongoing","Garden-Fresh Foods, Inc.","Milwaukee","WI","US","Voluntary: Firm Initiated","Press Release","IL, IN, MI, MN, MO, OH, PA, WI.","F-0866-2014","Class I","Garden-Fresh, Baked Egg Custard, 6/12 oz., 0 11596 07032 2, 0 11596 07032 2, 11/25/2013 - 12/7/2013 ","0 11596 07032 2, 0 11596 07032 2, 11/25/2013 - 12/7/2013 ","."," 919,616.31 total pounds, for all products","Garden-Fresh Foods is recalling various cut vegetables, ready-to-eat salads, slaw, spread and dip products sold under various brands and code dates manufactured prior to November 06, 2013 because they may be contaminated with Listeria monocytogenes.",11/7/2013,"11/07/2013",12/26/2013,"12/26/2013"
"Food",66819,"Ongoing","Garden-Fresh Foods, Inc.","Milwaukee","WI","US","Voluntary: Firm Initiated","Press Release","IL, IN, MI, MN, MO, OH, PA, WI.","F-0939-2014","Class I","Finest Traditions, Fat Free Four Bean Salad, 1/8 lb.,10 733147 10180 0, 11/25/2013 - 12/9/2013 ","10 733147 10180 0, 11/25/2013 - 12/9/2013 ","."," 919,616.31 total pounds, for all products","Garden-Fresh Foods is recalling various cut vegetables, ready-to-eat salads, slaw, spread and dip products sold under various brands and code dates manufactured prior to November 06, 2013 because they may be contaminated with Listeria monocytogenes.",11/7/2013,"11/07/2013",12/26/2013,"12/26/2013"
"Food",66819,"Ongoing","Garden-Fresh Foods, Inc.","Milwaukee","WI","US","Voluntary: Firm Initiated","Press Release","IL, IN, MI, MN, MO, OH, PA, WI.","F-0857-2014","Class I","Garden-Fresh, Apple Harvest Cole Slaw Kit, 1/10.5 lb., 0 11596 93032 9, 11/8/2013 - 11/13/2013 ","11596 93032 9, 11/8/2013 - 11/13/2013 ","."," 919,616.31 total pounds, for all products","Garden-Fresh Foods is recalling various cut vegetables, ready-to-eat salads, slaw, spread and dip products sold under various brands and code dates manufactured prior to November 06, 2013 because they may be contaminated with Listeria monocytogenes.",11/7/2013,"11/07/2013",12/26/2013,"12/26/2013"
"Food",66819,"Ongoing","Garden-Fresh Foods, Inc.","Milwaukee","WI","US","Voluntary: Firm Initiated","Press Release","IL, IN, MI, MN, MO, OH, PA, WI.","F-0904-2014","Class I","Garden-Fresh, Chopped Lettuce Romaine Blend 80/20, 4/5 lb., 0 11596 90150 3, 10/28/2013 - 11/6/2013 ","0 11596 90150 3, 10/28/2013 - 11/6/2013 ","."," 919,616.31 total pounds, for all products","Garden-Fresh Foods is recalling various cut vegetables, ready-to-eat salads, slaw, spread and dip products sold under various brands and code dates manufactured prior to November 06, 2013 because they may be contaminated with Listeria monocytogenes.",11/7/2013,"11/07/2013",12/26/2013,"12/26/2013"
"Food",66819,"Ongoing","Garden-Fresh Foods, Inc.","Milwaukee","WI","US","Voluntary: Firm Initiated","Press Release","IL, IN, MI, MN, MO, OH, PA, WI.","F-1004-2014","Class I","Spoon River, Pimento Cheese Spread, 1/5 lb., 0 11596 55678 9, 12/23/2013; ","0 11596 55678 9, 12/23/2013; ","."," 919,616.31 total pounds, for all products","Garden-Fresh Foods is recalling various cut vegetables, ready-to-eat salads, slaw, spread and dip products sold under various brands and code dates manufactured prior to November 06, 2013 because they may be contaminated with Listeria monocytogenes.",11/7/2013,"11/07/2013",12/26/2013,"12/26/2013"
"Food",66819,"Ongoing","Garden-Fresh Foods, Inc.","Milwaukee","WI","US","Voluntary: Firm Initiated","Press Release","IL, IN, MI, MN, MO, OH, PA, WI.","F-1024-2014","Class I","Weis, Red Potato Salad, 6/16 oz., 0 41497 05848 8, 0 00 41497 05848 8, 11/25/2013 - 11/28/2013; Weis, Red Potato Salad, 2/5 lb., 0 11596 51105 4, 11/21/2013 - 12/4/2013; ","0 41497 05848 8, 0 00 41497 05848 8, 11/25/2013 - 11/28/2013; 0 11596 51105 4, 11/21/2013 - 12/4/2013; ","."," 919,616.31 total pounds, for all products","Garden-Fresh Foods is recalling various cut vegetables, ready-to-eat salads, slaw, spread and dip products sold under various brands and code dates manufactured prior to November 06, 2013 because they may be contaminated with Listeria monocytogenes.",11/7/2013,"11/07/2013",12/26/2013,"12/26/2013"
"Food",66819,"Ongoing","Garden-Fresh Foods, Inc.","Milwaukee","WI","US","Voluntary: Firm Initiated","Press Release","IL, IN, MI, MN, MO, OH, PA, WI.","F-1003-2014","Class I","Weis, Pepper Cabbage, 2/5 lb., 0 11596 53102 1, 11/21/2013 - 11/28/2013; ","11596 53102 1, 11/21/2013 - 11/28/2013","."," 919,616.31 total pounds, for all products","Garden-Fresh Foods is recalling various cut vegetables, ready-to-eat salads, slaw, spread and dip products sold under various brands and code dates manufactured prior to November 06, 2013 because they may be contaminated with Listeria monocytogenes.",11/7/2013,"11/07/2013",12/26/2013,"12/26/2013"
"Food",66819,"Ongoing","Garden-Fresh Foods, Inc.","Milwaukee","WI","US","Voluntary: Firm Initiated","Press Release","IL, IN, MI, MN, MO, OH, PA, WI.","F-1053-2014","Class I","Finest Traditions, Southwest Taco Pasta, 1/8 lb., 10 733147 10287 6, 11/20/2013 - 12/9/2013 ","10 733147 10287 6, 11/20/2013 - 12/9/2013 ","."," 919,616.31 total pounds, for all products","Garden-Fresh Foods is recalling various cut vegetables, ready-to-eat salads, slaw, spread and dip products sold under various brands and code dates manufactured prior to November 06, 2013 because they may be contaminated with Listeria monocytogenes.",11/7/2013,"11/07/2013",12/26/2013,"12/26/2013"
"Food",66819,"Ongoing","Garden-Fresh Foods, Inc.","Milwaukee","WI","US","Voluntary: Firm Initiated","Press Release","IL, IN, MI, MN, MO, OH, PA, WI.","F-0906-2014","Class I","Knowlan's, Club Salad Base, 1/8 lb., 10 733147 00201 5, 11/25/2013 - 12/92013 ","10 733147 00201 5, 11/25/2013 - 12/92013 ","."," 919,616.31 total pounds, for all products","Garden-Fresh Foods is recalling various cut vegetables, ready-to-eat salads, slaw, spread and dip products sold under various brands and code dates manufactured prior to November 06, 2013 because they may be contaminated with Listeria monocytogenes.",11/7/2013,"11/07/2013",12/26/2013,"12/26/2013"
"Food",66819,"Ongoing","Garden-Fresh Foods, Inc.","Milwaukee","WI","US","Voluntary: Firm Initiated","Press Release","IL, IN, MI, MN, MO, OH, PA, WI.","F-0916-2014","Class I","Finest Traditions, Cranberry Relish, 2/5 lb., 10 733147 10862 5, 3/31/3014; Finest Traditions ,Cranberry Relish, 6/12 oz., 0 733147 10864 2, 10 733147 10863 2, 3/31/2014 ","10 733147 10862 5, 3/31/3014; 0 733147 10864 2, 10 733147 10863 2, 3/31/2014 ","."," 919,616.31 total pounds, for all products","Garden-Fresh Foods is recalling various cut vegetables, ready-to-eat salads, slaw, spread and dip products sold under various brands and code dates manufactured prior to November 06, 2013 because they may be contaminated with Listeria monocytogenes.",11/7/2013,"11/07/2013",12/26/2013,"12/26/2013"
"Food",66819,"Ongoing","Garden-Fresh Foods, Inc.","Milwaukee","WI","US","Voluntary: Firm Initiated","Press Release","IL, IN, MI, MN, MO, OH, PA, WI.","F-1016-2014","Class I","Finest Traditions, Pumpkin Mousse, 1/5 lb., 0 00 11596 55053 4, 11/15/2013 - 12/4/2013 Garden-Fresh, Pumpkin Mousse, 1/5 lb., 0 11596 55053 4, 11/16/2013 -12/4/2013 ","0 00 11596 55053 4, 11/15/2013 - 12/4/2013; 0 11596 55053 4, 11/16/2013 -12/4/2013 ","."," 919,616.31 total pounds, for all products","Garden-Fresh Foods is recalling various cut vegetables, ready-to-eat salads, slaw, spread and dip products sold under various brands and code dates manufactured prior to November 06, 2013 because they may be contaminated with Listeria monocytogenes.",11/7/2013,"11/07/2013",12/26/2013,"12/26/2013"
"Food",66819,"Ongoing","Garden-Fresh Foods, Inc.","Milwaukee","WI","US","Voluntary: Firm Initiated","Press Release","IL, IN, MI, MN, MO, OH, PA, WI.","F-1031-2014","Class I","Finest Traditions, Robust Pasta Salad, 1/8 lb., 10 733147 10145 9, 11/20/2013 - 12/9/2013; ","10 733147 10145 9, 11/20/2013 - 12/9/2013; ; ","."," 919,616.31 total pounds, for all products","Garden-Fresh Foods is recalling various cut vegetables, ready-to-eat salads, slaw, spread and dip products sold under various brands and code dates manufactured prior to November 06, 2013 because they may be contaminated with Listeria monocytogenes.",11/7/2013,"11/07/2013",12/26/2013,"12/26/2013"
"Food",66819,"Ongoing","Garden-Fresh Foods, Inc.","Milwaukee","WI","US","Voluntary: Firm Initiated","Press Release","IL, IN, MI, MN, MO, OH, PA, WI.","F-1091-2014","Class II","Martin's, White French Dressing, 4/2 lb., 0 11596 55350 4, 11/16/2013 - 11/30/2013; ","11596 55350 4, 11/16/2013 - 11/30/2013; ","."," 919,616.31 total pounds, for all products","Garden-Fresh Foods is recalling various cut vegetables, ready-to-eat salads, slaw, spread and dip products sold under various brands and code dates manufactured prior to November 06, 2013 because they may be contaminated with Listeria monocytogenes.",11/7/2013,"11/07/2013",12/26/2013,"12/26/2013"
"Food",66819,"Ongoing","Garden-Fresh Foods, Inc.","Milwaukee","WI","US","Voluntary: Firm Initiated","Press Release","IL, IN, MI, MN, MO, OH, PA, WI.","F-1039-2014","Class I","Garden-Fresh, Seafood Salad Rouille, 1/5 lb., 0 11596 55187 6, 12/6/2013; ","0 11596 55187 6, 12/6/2013; ; ","."," 919,616.31 total pounds, for all products","Garden-Fresh Foods is recalling various cut vegetables, ready-to-eat salads, slaw, spread and dip products sold under various brands and code dates manufactured prior to November 06, 2013 because they may be contaminated with Listeria monocytogenes.",11/7/2013,"11/07/2013",12/26/2013,"12/26/2013"
"Food",66819,"Ongoing","Garden-Fresh Foods, Inc.","Milwaukee","WI","US","Voluntary: Firm Initiated","Press Release","IL, IN, MI, MN, MO, OH, PA, WI.","F-1065-2014","Class I","Garden-Fresh, Summer Cole Slaw Kit, 1/3.875 lb. , 0 11596 43041 6, 11/9/2013 - 11/16/2013; ","0 11596 43041 6, 11/9/2013 - 11/16/2013; ","."," 919,616.31 total pounds, for all products","Garden-Fresh Foods is recalling various cut vegetables, ready-to-eat salads, slaw, spread and dip products sold under various brands and code dates manufactured prior to November 06, 2013 because they may be contaminated with Listeria monocytogenes.",11/7/2013,"11/07/2013",12/26/2013,"12/26/2013"
"Food",66819,"Ongoing","Garden-Fresh Foods, Inc.","Milwaukee","WI","US","Voluntary: Firm Initiated","Press Release","IL, IN, MI, MN, MO, OH, PA, WI.","F-0868-2014","Class I","Dairy Fresh Baked Potato Salad, 2/5 lb., 0 70163 40659 6, 12/1/2013 - 12/15/2013 ","0 70163 40659 6, 12/1/2013 - 12/15/2013 ","."," 919,616.31 total pounds, for all products","Garden-Fresh Foods is recalling various cut vegetables, ready-to-eat salads, slaw, spread and dip products sold under various brands and code dates manufactured prior to November 06, 2013 because they may be contaminated with Listeria monocytogenes.",11/7/2013,"11/07/2013",12/26/2013,"12/26/2013"
"Food",66819,"Ongoing","Garden-Fresh Foods, Inc.","Milwaukee","WI","US","Voluntary: Firm Initiated","Press Release","IL, IN, MI, MN, MO, OH, PA, WI.","F-0911-2014","Class I","Garden-Fresh, Country Potato Salad, 2/5 lb. ,0 11596 51075 0, 12/5/2013 "," 0 11596 51075 0, 12/5/2013 ","."," 919,616.31 total pounds, for all products","Garden-Fresh Foods is recalling various cut vegetables, ready-to-eat salads, slaw, spread and dip products sold under various brands and code dates manufactured prior to November 06, 2013 because they may be contaminated with Listeria monocytogenes.",11/7/2013,"11/07/2013",12/26/2013,"12/26/2013"
"Food",66819,"Ongoing","Garden-Fresh Foods, Inc.","Milwaukee","WI","US","Voluntary: Firm Initiated","Press Release","IL, IN, MI, MN, MO, OH, PA, WI.","F-1018-2014","Class I","Garden-Fresh, Rainbow Cabbage Shredded, 4/5 lb., 0 11596 50101 7, 10/28/2013 - 11/5/2013; ","0 11596 50101 7, 10/28/2013 - 11/5/2013; ","."," 919,616.31 total pounds, for all products","Garden-Fresh Foods is recalling various cut vegetables, ready-to-eat salads, slaw, spread and dip products sold under various brands and code dates manufactured prior to November 06, 2013 because they may be contaminated with Listeria monocytogenes.",11/7/2013,"11/07/2013",12/26/2013,"12/26/2013"
"Food",66819,"Ongoing","Garden-Fresh Foods, Inc.","Milwaukee","WI","US","Voluntary: Firm Initiated","Press Release","IL, IN, MI, MN, MO, OH, PA, WI.","F-1085-2014","Class I","Martin's, Veggie Party Tray Kit, 1/9.3 lb., 0 11596 90705 5, 11/9/2013 - 11/11/2013; ","0 11596 90705 5, 11/9/2013 - 11/11/2013; ","."," 919,616.31 total pounds, for all products","Garden-Fresh Foods is recalling various cut vegetables, ready-to-eat salads, slaw, spread and dip products sold under various brands and code dates manufactured prior to November 06, 2013 because they may be contaminated with Listeria monocytogenes.",11/7/2013,"11/07/2013",12/26/2013,"12/26/2013"
"Food",66819,"Ongoing","Garden-Fresh Foods, Inc.","Milwaukee","WI","US","Voluntary: Firm Initiated","Press Release","IL, IN, MI, MN, MO, OH, PA, WI.","F-1033-2014","Class I","Garden-Fresh, Romaine Chopped, 2'', 4/2.5 lb., 0 11596 50144 4, 11/1/2013; ","0 11596 50144 4, 11/1/2013; ; ","."," 919,616.31 total pounds, for all products","Garden-Fresh Foods is recalling various cut vegetables, ready-to-eat salads, slaw, spread and dip products sold under various brands and code dates manufactured prior to November 06, 2013 because they may be contaminated with Listeria monocytogenes.",11/7/2013,"11/07/2013",12/26/2013,"12/26/2013"
"Food",66819,"Ongoing","Garden-Fresh Foods, Inc.","Milwaukee","WI","US","Voluntary: Firm Initiated","Press Release","IL, IN, MI, MN, MO, OH, PA, WI.","F-1099-2014","Class I","Grandpa's ,Red Skin Potato Salad, 2/5 lb., 0 11596 51080 4, 11/22/2013 - 12/10/2013; Grandpa's, Red Skin Potato Salad, 12/16 oz,. 0 11596 14061 2, 0 11596 24061 9, 11/25/2013 - 12/10/2013; ","0 11596 51080 4, 11/22/2013 - 12/10/2013; 0 11596 14061 2, 0 11596 24061 9, 11/25/2013 - 12/10/2013; ","."," 919,616.31 total pounds, for all products","Garden-Fresh Foods is recalling various cut vegetables, ready-to-eat salads, slaw, spread and dip products sold under various brands and code dates manufactured prior to November 06, 2013 because they may be contaminated with Listeria monocytogenes.",11/7/2013,"11/07/2013",12/26/2013,"12/26/2013"
"Food",66819,"Ongoing","Garden-Fresh Foods, Inc.","Milwaukee","WI","US","Voluntary: Firm Initiated","Press Release","IL, IN, MI, MN, MO, OH, PA, WI.","F-1054-2014","Class I","Garden-Fresh, Southwestern Pasta, 1/5 lb., 0 11596 52046 9, 11/25/2013 - 12/6/2013 ","0 11596 52046 9, 11/25/2013 - 12/6/2013 ","."," 919,616.31 total pounds, for all products","Garden-Fresh Foods is recalling various cut vegetables, ready-to-eat salads, slaw, spread and dip products sold under various brands and code dates manufactured prior to November 06, 2013 because they may be contaminated with Listeria monocytogenes.",11/7/2013,"11/07/2013",12/26/2013,"12/26/2013"
"Food",66819,"Ongoing","Garden-Fresh Foods, Inc.","Milwaukee","WI","US","Voluntary: Firm Initiated","Press Release","IL, IN, MI, MN, MO, OH, PA, WI.","F-0981-2014","Class I","Garden-Fresh, Lettuce Tossed, 1/5 lb., 0 11596 50149 9 , 11/4/2013; ","0 11596 50149 9 , 11/4/2013; ","."," 919,616.31 total pounds, for all products","Garden-Fresh Foods is recalling various cut vegetables, ready-to-eat salads, slaw, spread and dip products sold under various brands and code dates manufactured prior to November 06, 2013 because they may be contaminated with Listeria monocytogenes.",11/7/2013,"11/07/2013",12/26/2013,"12/26/2013"
"Food",66819,"Ongoing","Garden-Fresh Foods, Inc.","Milwaukee","WI","US","Voluntary: Firm Initiated","Press Release","IL, IN, MI, MN, MO, OH, PA, WI.","F-0863-2014","Class I","Roundy's Bagel Spread, 12/12 oz., 0 11596 06156 6 , 0 00 11596 06156 6, 11/22/2013 - 11/26/2013; ","0 11596 06156 6 , 0 00 11596 06156 6, 11/22/2013 - 11/26/2013; ","."," 919,616.31 total pounds, for all products","Garden-Fresh Foods is recalling various cut vegetables, ready-to-eat salads, slaw, spread and dip products sold under various brands and code dates manufactured prior to November 06, 2013 because they may be contaminated with Listeria monocytogenes.",11/7/2013,"11/07/2013",12/26/2013,"12/26/2013"
"Food",66819,"Ongoing","Garden-Fresh Foods, Inc.","Milwaukee","WI","US","Voluntary: Firm Initiated","Press Release","IL, IN, MI, MN, MO, OH, PA, WI.","F-0988-2014","Class I","Finest Traditions, Mint Chocolate Chip Cookie Mousse, 1/5 lb., 10 733147 11017 8, 11/20/2013 - 12/9/2013; Garden-Fresh, Mint Chocolate Chip Cookie Mousse, 1/5 lb., 0 11596 55069 5, 11/22/2013 - 12/9/2013; ","10 733147 11017 8 11/20/2013 - 12/9/2013; 0 11596 55069 5 11/22/2013 - 12/9/2013; ","."," 919,616.31 total pounds, for all products","Garden-Fresh Foods is recalling various cut vegetables, ready-to-eat salads, slaw, spread and dip products sold under various brands and code dates manufactured prior to November 06, 2013 because they may be contaminated with Listeria monocytogenes.",11/7/2013,"11/07/2013",12/26/2013,"12/26/2013"
"Food",66819,"Ongoing","Garden-Fresh Foods, Inc.","Milwaukee","WI","US","Voluntary: Firm Initiated","Press Release","IL, IN, MI, MN, MO, OH, PA, WI.","F-0908-2014","Class I","Garden-Fresh, Combo Bean Salad 2/5 lb., 0 11596 52013 1, 11/22/2013 - 12/31/2013 ","0 11596 52013 1, 11/22/2013 - 12/31/2013 ","."," 919,616.31 total pounds, for all products","Garden-Fresh Foods is recalling various cut vegetables, ready-to-eat salads, slaw, spread and dip products sold under various brands and code dates manufactured prior to November 06, 2013 because they may be contaminated with Listeria monocytogenes.",11/7/2013,"11/07/2013",12/26/2013,"12/26/2013"
"Food",66819,"Ongoing","Garden-Fresh Foods, Inc.","Milwaukee","WI","US","Voluntary: Firm Initiated","Press Release","IL, IN, MI, MN, MO, OH, PA, WI.","F-0947-2014","Class II","Finest Traditions, Fresh Salsa Mild, 6/11 oz., 10 733147 109943, 12/9/2013; ","10 733147 109943, 12/9/2013; ","."," 919,616.31 total pounds, for all products","Garden-Fresh Foods is recalling various cut vegetables, ready-to-eat salads, slaw, spread and dip products sold under various brands and code dates manufactured prior to November 06, 2013 because they may be contaminated with Listeria monocytogenes.",11/7/2013,"11/07/2013",12/26/2013,"12/26/2013"
"Food",66819,"Ongoing","Garden-Fresh Foods, Inc.","Milwaukee","WI","US","Voluntary: Firm Initiated","Press Release","IL, IN, MI, MN, MO, OH, PA, WI.","F-0927-2014","Class I","Chef's Kitchen, Deluxe Egg Salad, 1/5 lb., 0 11596 52044 5, 11/17/2013 - 12/4/2013; Garden-Fresh , Deluxe Egg Salad , 1/5 lb., 0 11596 52043 8 ,11/16/2013 - 12/2/2013 ","0 11596 52044 5, 11/17/2013 - 12/4/2013; 0 11596 52043 8 ,11/16/2013 - 12/2/2013 ","."," 919,616.31 total pounds, for all products","Garden-Fresh Foods is recalling various cut vegetables, ready-to-eat salads, slaw, spread and dip products sold under various brands and code dates manufactured prior to November 06, 2013 because they may be contaminated with Listeria monocytogenes.",11/7/2013,"11/07/2013",12/26/2013,"12/26/2013"
"Food",66819,"Ongoing","Garden-Fresh Foods, Inc.","Milwaukee","WI","US","Voluntary: Firm Initiated","Press Release","IL, IN, MI, MN, MO, OH, PA, WI.","F-0948-2014","Class II","Farmer's Market, Fresh Salsa Serrano Spicy, 6/15 oz., 0 11596 06143 6, 0 00 11596 06143 6, 12/14/2013 - 12/15/2013; ","0 11596 06143 6, 0 00 11596 06143 6, 12/14/2013 - 12/15/2013; ","."," 919,616.31 total pounds, for all products","Garden-Fresh Foods is recalling various cut vegetables, ready-to-eat salads, slaw, spread and dip products sold under various brands and code dates manufactured prior to November 06, 2013 because they may be contaminated with Listeria monocytogenes.",11/7/2013,"11/07/2013",12/26/2013,"12/26/2013"
"Food",66819,"Ongoing","Garden-Fresh Foods, Inc.","Milwaukee","WI","US","Voluntary: Firm Initiated","Press Release","IL, IN, MI, MN, MO, OH, PA, WI.","F-0871-2014","Class I","Garden-Fresh, Black Bean Couscous, 1/5 lb., 0 11596 55620 8, 11/18/2013 - 11/26/2013 ","0 11596 55620 8, 11/18/2013 - 11/26/2013 ","."," 919,616.31 total pounds, for all products","Garden-Fresh Foods is recalling various cut vegetables, ready-to-eat salads, slaw, spread and dip products sold under various brands and code dates manufactured prior to November 06, 2013 because they may be contaminated with Listeria monocytogenes.",11/7/2013,"11/07/2013",12/26/2013,"12/26/2013"
"Food",66819,"Ongoing","Garden-Fresh Foods, Inc.","Milwaukee","WI","US","Voluntary: Firm Initiated","Press Release","IL, IN, MI, MN, MO, OH, PA, WI.","F-0893-2014","Class I","Finest Traditions, Cheddar & Bacon Potato Filling, 1/8 lb. , 10 733147 10262 3 11/11/2013 - 11/18/2013 ","10 733147 10262 3 11/11/2013 - 11/18/2013 ","."," 919,616.31 total pounds, for all products","Garden-Fresh Foods is recalling various cut vegetables, ready-to-eat salads, slaw, spread and dip products sold under various brands and code dates manufactured prior to November 06, 2013 because they may be contaminated with Listeria monocytogenes.",11/7/2013,"11/07/2013",12/26/2013,"12/26/2013"
"Food",66819,"Ongoing","Garden-Fresh Foods, Inc.","Milwaukee","WI","US","Voluntary: Firm Initiated","Press Release","IL, IN, MI, MN, MO, OH, PA, WI.","F-1008-2014","Class I","Weis, Potato & Egg Salad, 12/16 oz., 0 41497 05841 9, 0 00 41497 05841 9, 11/25/2013 - 12/3/2013; Weis, Potato & Egg Salad, 4/3 lb., 0 41497 05902 7, 0 00 41497 05902 7, 11/21/2013 - 11/28/2013; Weis, Potato & Egg Salad, 2/5 lb., 0 11596 51101 6, 11/21/2013 - 12/3/2013; Dairy Fresh, Potato Salad with Egg , 2/5 lb., 0 70163 89085 5 12/5/2013 ","0 41497 05841 9 0 00 41497 05841 9 11/25/2013 - 12/3/2013; 0 41497 05902 7 0 00 41497 05902 7 11/21/2013 - 11/28/2013; 0 11596 51101 6 11/21/2013 - 12/3/2013; 0 70163 89085 5 12/5/2013;","."," 919,616.31 total pounds, for all products","Garden-Fresh Foods is recalling various cut vegetables, ready-to-eat salads, slaw, spread and dip products sold under various brands and code dates manufactured prior to November 06, 2013 because they may be contaminated with Listeria monocytogenes.",11/7/2013,"11/07/2013",12/26/2013,"12/26/2013"
"Food",66819,"Ongoing","Garden-Fresh Foods, Inc.","Milwaukee","WI","US","Voluntary: Firm Initiated","Press Release","IL, IN, MI, MN, MO, OH, PA, WI.","F-1058-2014","Class I","Garden-Fresh, Spinach Pasta Salad Kit 1/5.25 lb., 0 11596 62072 5, 11/21/2013 - 12/9/2013 ","0 11596 62072 5, 11/21/2013 - 12/9/2013 ","."," 919,616.31 total pounds, for all products","Garden-Fresh Foods is recalling various cut vegetables, ready-to-eat salads, slaw, spread and dip products sold under various brands and code dates manufactured prior to November 06, 2013 because they may be contaminated with Listeria monocytogenes.",11/7/2013,"11/07/2013",12/26/2013,"12/26/2013"
"Food",66819,"Ongoing","Garden-Fresh Foods, Inc.","Milwaukee","WI","US","Voluntary: Firm Initiated","Press Release","IL, IN, MI, MN, MO, OH, PA, WI.","F-0898-2014","Class I","Our Own, Chili Con Queso Dip, 1/5 lb., 0 11596 55189 0 , 11/21/2013 - 12/9/2013 ","0 11596 55189 0 , 11/21/2013 - 12/9/2013 ","."," 919,616.31 total pounds, for all products","Garden-Fresh Foods is recalling various cut vegetables, ready-to-eat salads, slaw, spread and dip products sold under various brands and code dates manufactured prior to November 06, 2013 because they may be contaminated with Listeria monocytogenes.",11/7/2013,"11/07/2013",12/26/2013,"12/26/2013"
"Food",66819,"Ongoing","Garden-Fresh Foods, Inc.","Milwaukee","WI","US","Voluntary: Firm Initiated","Press Release","IL, IN, MI, MN, MO, OH, PA, WI.","F-0855-2014","Class I","Marsh, Amish Potato Salad, 2/5 lb., 0 11596 51009 5, 11/21/2013 - 11/30/2013; Weis, Amish Potato Salad, 12/16 oz, 0 41497 05845 7, 0 0041497 05845 7, 11/21/2013 - 12/3/2013; Weis,Amish Potato Salad, 4/3 lb.,0 41497 05901 0, 0 00 41497 05901 0, 11/21/2013 - 11/28/2013; Weis, Amish Potato Salad, 2/5 lb., 0 11596 51103 0 , 11/21/2013 - 11/29/2013; ","0 11596 51009 5, 11/21/2013 - 11/30/2013; 0 41497 05845 7, 0 0041497 05845 7, 11/21/2013 - 12/3/2013; 0 41497 05901 0, 0 00 41497 05901 0, 11/21/2013 - 11/28/2013; 0 11596 51103 0 , 11/21/2013 - 11/29/2013; ","."," 919,616.31 total pounds, for all products","Garden-Fresh Foods is recalling various cut vegetables, ready-to-eat salads, slaw, spread and dip products sold under various brands and code dates manufactured prior to November 06, 2013 because they may be contaminated with Listeria monocytogenes.",11/7/2013,"11/07/2013",12/26/2013,"12/26/2013"
"Food",66819,"Ongoing","Garden-Fresh Foods, Inc.","Milwaukee","WI","US","Voluntary: Firm Initiated","Press Release","IL, IN, MI, MN, MO, OH, PA, WI.","F-0901-2014","Class I","Garden-Fresh, Chopped Broccoli / Cauliflower Salad Base, 1/5 lb., 0 11596 55188 3, 11/27/2013 - 12/5/2013 ","0 11596 55188 3, 11/27/2013 - 12/5/2013 ","."," 919,616.31 total pounds, for all products","Garden-Fresh Foods is recalling various cut vegetables, ready-to-eat salads, slaw, spread and dip products sold under various brands and code dates manufactured prior to November 06, 2013 because they may be contaminated with Listeria monocytogenes.",11/7/2013,"11/07/2013",12/26/2013,"12/26/2013"
"Food",66819,"Ongoing","Garden-Fresh Foods, Inc.","Milwaukee","WI","US","Voluntary: Firm Initiated","Press Release","IL, IN, MI, MN, MO, OH, PA, WI.","F-1081-2014","Class I","Garden-Fresh, Tuna Twist Salad, 1/5 lb., 0 11596 55134 0, 11/21/2013 - 12/7/2013; ","0 11596 55134 0, 11/21/2013 - 12/7/2013","."," 919,616.31 total pounds, for all products","Garden-Fresh Foods is recalling various cut vegetables, ready-to-eat salads, slaw, spread and dip products sold under various brands and code dates manufactured prior to November 06, 2013 because they may be contaminated with Listeria monocytogenes.",11/7/2013,"11/07/2013",12/26/2013,"12/26/2013"
"Food",66819,"Ongoing","Garden-Fresh Foods, Inc.","Milwaukee","WI","US","Voluntary: Firm Initiated","Press Release","IL, IN, MI, MN, MO, OH, PA, WI.","F-1067-2014","Class I","Garden-Fresh, Sweet & Sour Cucumber, 2/5 lb., 0 11596 52014 8, 11/15/2013 - 11/30/2013; "," 0 11596 52014 8, 11/15/2013 - 11/30/2013; ","."," 919,616.31 total pounds, for all products","Garden-Fresh Foods is recalling various cut vegetables, ready-to-eat salads, slaw, spread and dip products sold under various brands and code dates manufactured prior to November 06, 2013 because they may be contaminated with Listeria monocytogenes.",11/7/2013,"11/07/2013",12/26/2013,"12/26/2013"
"Food",66819,"Ongoing","Garden-Fresh Foods, Inc.","Milwaukee","WI","US","Voluntary: Firm Initiated","Press Release","IL, IN, MI, MN, MO, OH, PA, WI.","F-1096-2014","Class I","Garden-Fresh, Whole Wheat Pasta with Sun Dried Tomatoes, 1/5 lb., 0 11596 52094 0, 11/30/2013 -12/14/2013; ","0 11596 52094 0, 11/30/2013 -12/14/2013; ","."," 919,616.31 total pounds, for all products","Garden-Fresh Foods is recalling various cut vegetables, ready-to-eat salads, slaw, spread and dip products sold under various brands and code dates manufactured prior to November 06, 2013 because they may be contaminated with Listeria monocytogenes.",11/7/2013,"11/07/2013",12/26/2013,"12/26/2013"
"Food",66819,"Ongoing","Garden-Fresh Foods, Inc.","Milwaukee","WI","US","Voluntary: Firm Initiated","Press Release","IL, IN, MI, MN, MO, OH, PA, WI.","F-1086-2014","Class I","Dairy Fresh, Venetian Bow Tie Pasta, 1/5 lb., 0 11596 50042 3, 11/26/2013; Garden-Fresh, Venetian Bow Tie Pasta, 1/5 lb., 0 11596 52027 8, 11/21/2013 - 12/10/2013; ","0 11596 50042 3, 11/26/2013; 0 11596 52027 8, 11/21/2013 - 12/10/2013; ","."," 919,616.31 total pounds, for all products","Garden-Fresh Foods is recalling various cut vegetables, ready-to-eat salads, slaw, spread and dip products sold under various brands and code dates manufactured prior to November 06, 2013 because they may be contaminated with Listeria monocytogenes.",11/7/2013,"11/07/2013",12/26/2013,"12/26/2013"
"Food",66819,"Ongoing","Garden-Fresh Foods, Inc.","Milwaukee","WI","US","Voluntary: Firm Initiated","Press Release","IL, IN, MI, MN, MO, OH, PA, WI.","F-0848-2014","Class I","Garden-Fresh, American Potato Salad,,6/48 oz., 0 11596 34310 5, 0 11596 34310 5 12/3/2013 - 12/10/2013; Garden-Fresh, American Potato Salad, 2/5 lb., 0 11596 51010 1 11/22/2013 - 12/5/2013; Garden-Fresh, American Potato Salad, 12/16 oz., 0 11596 14015 5, 0 11596 14015 5 11/21/2013 -12/10/2013; Garden-Fresh, American Potato Salad, 8/32 oz., 0 11596 24200 2, 0 11596 24200 2 11/25/2013 - 12/4/2013; Spartan, American Potato Salad, , 6/16 oz., 0 11213 90320 0, 0 00 11213 90320 0 11/25/2013 - 12/2/2013; Garden-Fresh,Large Diced American Potato Salad, 2/5 lb., 0 11596 91018 5 11/22/2013 - 12/9/2013; ","0 11596 34310 5, 0 11596 34310 5 = 12/3/2013 - 12/10/2013; 0 11596 51010 1= 11/22/2013 - 12/5/2013; 0 11596 14015 5, 0 11596 14015 5= 11/21/2013 -12/10/2013; 0 11596 24200 2, 0 11596 24200 2= 11/25/2013 - 12/4/2013; 0 11213 90320 0, 0 00 11213 90320 0= 11/25/2013 - 12/2/2013 0 11596 91018 5 11/22/2013 - 12/9/2013; ","."," 919,616.31 total pounds, for all products","Garden-Fresh Foods is recalling various cut vegetables, ready-to-eat salads, slaw, spread and dip products sold under various brands and code dates manufactured prior to November 06, 2013 because they may be contaminated with Listeria monocytogenes.",11/7/2013,"11/07/2013",12/26/2013,"12/26/2013"
"Food",66819,"Ongoing","Garden-Fresh Foods, Inc.","Milwaukee","WI","US","Voluntary: Firm Initiated","Press Release","IL, IN, MI, MN, MO, OH, PA, WI.","F-1014-2014","Class I","Garden-Fresh, Premium Tuna Salad, 1/5 lb., 0 11596 55101 2, 11/26/2013 - 12/11/2013 ","0 11596 55101 2, 11/26/2013 - 12/11/2013 ","."," 919,616.31 total pounds, for all products","Garden-Fresh Foods is recalling various cut vegetables, ready-to-eat salads, slaw, spread and dip products sold under various brands and code dates manufactured prior to November 06, 2013 because they may be contaminated with Listeria monocytogenes.",11/7/2013,"11/07/2013",12/26/2013,"12/26/2013"
"Food",66819,"Ongoing","Garden-Fresh Foods, Inc.","Milwaukee","WI","US","Voluntary: Firm Initiated","Press Release","IL, IN, MI, MN, MO, OH, PA, WI.","F-1006-2014","Class I","Finest Traditions, Pistachio Whip , 1/8 lb., 10 733147 00020 2, 11/11/2013 - 11/25/2013 ","10 733147 00020 2, 11/11/2013 - 11/25/2013 ","."," 919,616.31 total pounds, for all products","Garden-Fresh Foods is recalling various cut vegetables, ready-to-eat salads, slaw, spread and dip products sold under various brands and code dates manufactured prior to November 06, 2013 because they may be contaminated with Listeria monocytogenes.",11/7/2013,"11/07/2013",12/26/2013,"12/26/2013"
"Food",66819,"Ongoing","Garden-Fresh Foods, Inc.","Milwaukee","WI","US","Voluntary: Firm Initiated","Press Release","IL, IN, MI, MN, MO, OH, PA, WI.","F-0980-2014","Class I","Garden-Fresh, Lettuce Chopped 2'', 4/5 lb., 0 11596 50155 0, 10/22/2013 - 11/14/2013; Garden-Fresh, Lettuce Shredded 1/8'', 4/5 lb., 0 11596 50157 4, 10/30/2013 - 11/9/2013; Garden-Fresh, Lettuce Shredded 1/8'', 1/5 lb., 0 11596 50159 8, 10/30/2013 - 11/6/2013; Garden-Fresh, Lettuce Shredded 3/16'', 4/2.5 lb. , 0 11596 50169 7, 11/9/2013; Garden-Fresh, Lettuce Tossed, 1/5 lb., 0 11596 50149 9 , 11/4/2013; ","0 11596 50155 0 10/22/2013 - 11/14/2013; 0 11596 50157 4 10/30/2013 - 11/9/2013; 0 11596 50159 8 10/30/2013 - 11/6/2013; 0 11596 50169 7 11/9/2013; 0 11596 50149 9 11/4/2013 ;","."," 919,616.31 total pounds, for all products","Garden-Fresh Foods is recalling various cut vegetables, ready-to-eat salads, slaw, spread and dip products sold under various brands and code dates manufactured prior to November 06, 2013 because they may be contaminated with Listeria monocytogenes.",11/7/2013,"11/07/2013",12/26/2013,"12/26/2013"
"Food",66819,"Ongoing","Garden-Fresh Foods, Inc.","Milwaukee","WI","US","Voluntary: Firm Initiated","Press Release","IL, IN, MI, MN, MO, OH, PA, WI.","F-0996-2014","Class I","Garden-Fresh, Parmesan Pepper Salad Kit, 1/6.3 lb., 0 11596 73037 0, 11/9/2013 - 11/12/2013; ","0 11596 73037 0, 11/9/2013 - 11/12/2013; ","."," 919,616.31 total pounds, for all products","Garden-Fresh Foods is recalling various cut vegetables, ready-to-eat salads, slaw, spread and dip products sold under various brands and code dates manufactured prior to November 06, 2013 because they may be contaminated with Listeria monocytogenes.",11/7/2013,"11/07/2013",12/26/2013,"12/26/2013"
"Food",66819,"Ongoing","Garden-Fresh Foods, Inc.","Milwaukee","WI","US","Voluntary: Firm Initiated","Press Release","IL, IN, MI, MN, MO, OH, PA, WI.","F-1007-2014","Class I","Garden-Fresh, Poppy Seed Cole Slaw, 1/8 lb., 0 11596 83016 2, 11/21/2013 - 12/5/2013; ","0 11596 83016 2, 11/21/2013 - 12/5/2013; ","."," 919,616.31 total pounds, for all products","Garden-Fresh Foods is recalling various cut vegetables, ready-to-eat salads, slaw, spread and dip products sold under various brands and code dates manufactured prior to November 06, 2013 because they may be contaminated with Listeria monocytogenes.",11/7/2013,"11/07/2013",12/26/2013,"12/26/2013"
"Food",66819,"Ongoing","Garden-Fresh Foods, Inc.","Milwaukee","WI","US","Voluntary: Firm Initiated","Press Release","IL, IN, MI, MN, MO, OH, PA, WI.","F-1087-2014","Class I","Garden-Fresh, Vinegar & Oil Cole Slaw, 1/8 lb., 0 11596 83000 1, 11/21/2013 - 12/6/2013; Our Own, Vinegar & Oil Cole Slaw ,1/8 lb., 0 11596 83002 5, 11/21/2013 - 12/6/2013; "," 0 11596 83000 1, 11/21/2013 - 12/6/2013; 0 11596 83002 5, 11/21/2013 - 12/6/2013; ","."," 919,616.31 total pounds, for all products","Garden-Fresh Foods is recalling various cut vegetables, ready-to-eat salads, slaw, spread and dip products sold under various brands and code dates manufactured prior to November 06, 2013 because they may be contaminated with Listeria monocytogenes.",11/7/2013,"11/07/2013",12/26/2013,"12/26/2013"
"Food",66819,"Ongoing","Garden-Fresh Foods, Inc.","Milwaukee","WI","US","Voluntary: Firm Initiated","Press Release","IL, IN, MI, MN, MO, OH, PA, WI.","F-0964-2014","Class I","Garden-Fresh, Health Salad, 1/8 lb,. 0 11 11596 82114 2, 11/21/2013 - 12/5/2013; ","0 11 11596 82114 2, 11/21/2013 - 12/5/2013; ","."," 919,616.31 total pounds, for all products","Garden-Fresh Foods is recalling various cut vegetables, ready-to-eat salads, slaw, spread and dip products sold under various brands and code dates manufactured prior to November 06, 2013 because they may be contaminated with Listeria monocytogenes.",11/7/2013,"11/07/2013",12/26/2013,"12/26/2013"
"Food",66819,"Ongoing","Garden-Fresh Foods, Inc.","Milwaukee","WI","US","Voluntary: Firm Initiated","Press Release","IL, IN, MI, MN, MO, OH, PA, WI.","F-0885-2014","Class I","Garden-Fresh, Cabbage Chopped with Red Cabbage, 4/5 lb. , 0 11596 50119 2, 10/31/2013 "," 0 11596 50119 2, 10/31/2013 ","."," 919,616.31 total pounds, for all products","Garden-Fresh Foods is recalling various cut vegetables, ready-to-eat salads, slaw, spread and dip products sold under various brands and code dates manufactured prior to November 06, 2013 because they may be contaminated with Listeria monocytogenes.",11/7/2013,"11/07/2013",12/26/2013,"12/26/2013"
"Food",66819,"Ongoing","Garden-Fresh Foods, Inc.","Milwaukee","WI","US","Voluntary: Firm Initiated","Press Release","IL, IN, MI, MN, MO, OH, PA, WI.","F-1084-2014","Class I","Garden-Fresh, Vegetable Blend, 1/2.5 lb., 0 11596 50750 7, 10/31/2103 - 11/18/2013; ","0 11596 50750 7, 10/31/2103 - 11/18/2013; ","."," 919,616.31 total pounds, for all products","Garden-Fresh Foods is recalling various cut vegetables, ready-to-eat salads, slaw, spread and dip products sold under various brands and code dates manufactured prior to November 06, 2013 because they may be contaminated with Listeria monocytogenes.",11/7/2013,"11/07/2013",12/26/2013,"12/26/2013"
"Food",66819,"Ongoing","Garden-Fresh Foods, Inc.","Milwaukee","WI","US","Voluntary: Firm Initiated","Press Release","IL, IN, MI, MN, MO, OH, PA, WI.","F-1050-2014","Class I","Grandpa's, Sour Cream Cucumber Salad, 2/5 lb, 0 11596 52080 3, 11/11/2013 - 11/25/2013; Rogge's, Sour Cream Cucumber Salad, 2/5 lb, 0 11596 52027 5, 11/12/2013; ","0 11596 52080 3, 11/11/2013 - 11/25/2013; 0 11596 52027 5, 11/12/2013; ","."," 919,616.31 total pounds, for all products","Garden-Fresh Foods is recalling various cut vegetables, ready-to-eat salads, slaw, spread and dip products sold under various brands and code dates manufactured prior to November 06, 2013 because they may be contaminated with Listeria monocytogenes.",11/7/2013,"11/07/2013",12/26/2013,"12/26/2013"
"Food",66819,"Ongoing","Garden-Fresh Foods, Inc.","Milwaukee","WI","US","Voluntary: Firm Initiated","Press Release","IL, IN, MI, MN, MO, OH, PA, WI.","F-0984-2014","Class I","Knowlan's, Mandarin Salad Base, 1/8 lb., 10 733147 10153 4, 11/25/2013 - 12/92013 ","10 733147 10153 4, 11/25/2013 - 12/92013 ","."," 919,616.31 total pounds, for all products","Garden-Fresh Foods is recalling various cut vegetables, ready-to-eat salads, slaw, spread and dip products sold under various brands and code dates manufactured prior to November 06, 2013 because they may be contaminated with Listeria monocytogenes.",11/7/2013,"11/07/2013",12/26/2013,"12/26/2013"
"Food",66819,"Ongoing","Garden-Fresh Foods, Inc.","Milwaukee","WI","US","Voluntary: Firm Initiated","Press Release","IL, IN, MI, MN, MO, OH, PA, WI.","F-1040-2014","Class I","Weis, Seafood Salad Supreme ,1/5 lb., 0 11596 55218 7, 11/21/2013 - 11/29/2013; ","11596 55218 7, 11/21/2013 - 11/29/2013; ","."," 919,616.31 total pounds, for all products","Garden-Fresh Foods is recalling various cut vegetables, ready-to-eat salads, slaw, spread and dip products sold under various brands and code dates manufactured prior to November 06, 2013 because they may be contaminated with Listeria monocytogenes.",11/7/2013,"11/07/2013",12/26/2013,"12/26/2013"
"Food",66819,"Ongoing","Garden-Fresh Foods, Inc.","Milwaukee","WI","US","Voluntary: Firm Initiated","Press Release","IL, IN, MI, MN, MO, OH, PA, WI.","F-0874-2014","Class I","Finest Traditions, Blue Cheese Potato Salad, 1/8 lb., 10 733147 10137 4, 11/11/2013 - 11/25/2013 ","10 733147 10137 4, 11/11/2013 - 11/25/2013 ","."," 919,616.31 total pounds, for all products","Garden-Fresh Foods is recalling various cut vegetables, ready-to-eat salads, slaw, spread and dip products sold under various brands and code dates manufactured prior to November 06, 2013 because they may be contaminated with Listeria monocytogenes.",11/7/2013,"11/07/2013",12/26/2013,"12/26/2013"
"Food",66819,"Ongoing","Garden-Fresh Foods, Inc.","Milwaukee","WI","US","Voluntary: Firm Initiated","Press Release","IL, IN, MI, MN, MO, OH, PA, WI.","F-1061-2014","Class I","Finest Traditions, Steakhouse Potato Salad, 1/8 lb., 10 733147 10773 4, 11/11/2013 - 12/9/2013 Grandpa's, Steakhouse Potato Salad, 12/16 oz. ,0 11596 14068 1, 0 11596 24068 8, 11/25/2013 - 12/10/2013 Grandpa's, Steakhouse Potato Salad, 2/5 lb., 0 11596 55604 8, 11/21/2013 - 12/6/2013 ","10 733147 10773 4 11/11/2013 - 12/9/2013; 0 11596 24068 8 11/25/2013 - 12/10/2013; 0 11596 55604 8 11/21/2013 - 12/6/2013; ","."," 919,616.31 total pounds, for all products","Garden-Fresh Foods is recalling various cut vegetables, ready-to-eat salads, slaw, spread and dip products sold under various brands and code dates manufactured prior to November 06, 2013 because they may be contaminated with Listeria monocytogenes.",11/7/2013,"11/07/2013",12/26/2013,"12/26/2013"
"Food",66819,"Ongoing","Garden-Fresh Foods, Inc.","Milwaukee","WI","US","Voluntary: Firm Initiated","Press Release","IL, IN, MI, MN, MO, OH, PA, WI.","F-0880-2014","Class I","Garden-Fresh, Broccoli Cheese Salad Kit, 1/11.25 lb., 0 11596 93038 1 11/9/2013 - 11/13/2013 "," 0 11596 93038 1 11/9/2013 - 11/13/2013 ","."," 919,616.31 total pounds, for all products","Garden-Fresh Foods is recalling various cut vegetables, ready-to-eat salads, slaw, spread and dip products sold under various brands and code dates manufactured prior to November 06, 2013 because they may be contaminated with Listeria monocytogenes.",11/7/2013,"11/07/2013",12/26/2013,"12/26/2013"
"Food",66819,"Ongoing","Garden-Fresh Foods, Inc.","Milwaukee","WI","US","Voluntary: Firm Initiated","Press Release","IL, IN, MI, MN, MO, OH, PA, WI.","F-0879-2014","Class I","Garden-Fresh, Broccoli Cheese Salad Base, 1/5 lb., 0 11596 55136 4, 11/25/2013 - 12/5/2013 ","11596 55136 4, 11/25/2013 - 12/5/2013 ","."," 919,616.31 total pounds, for all products","Garden-Fresh Foods is recalling various cut vegetables, ready-to-eat salads, slaw, spread and dip products sold under various brands and code dates manufactured prior to November 06, 2013 because they may be contaminated with Listeria monocytogenes.",11/7/2013,"11/07/2013",12/26/2013,"12/26/2013"
"Food",66819,"Ongoing","Garden-Fresh Foods, Inc.","Milwaukee","WI","US","Voluntary: Firm Initiated","Press Release","IL, IN, MI, MN, MO, OH, PA, WI.","F-0865-2014","Class I","Finest Traditions, Baked Bread Pudding, 1/7 lb., 10 733147 10099 5, 11/21/2013 - 12/10/2013; Garden-Fresh, Baked Bread Pudding, 6/12 oz., 0 11596 07034 6, 0 11596 07034 6, 11/27/2013 - 12/7/2013; ","10 733147 10099 5, 11/21/2013 - 12/10/2013; 0 11596 07034 6, 0 11596 07034 6, 11/27/2013 - 12/7/2013; ","."," 919,616.31 total pounds, for all products","Garden-Fresh Foods is recalling various cut vegetables, ready-to-eat salads, slaw, spread and dip products sold under various brands and code dates manufactured prior to November 06, 2013 because they may be contaminated with Listeria monocytogenes.",11/7/2013,"11/07/2013",12/26/2013,"12/26/2013"
"Food",66819,"Ongoing","Garden-Fresh Foods, Inc.","Milwaukee","WI","US","Voluntary: Firm Initiated","Press Release","IL, IN, MI, MN, MO, OH, PA, WI.","F-0878-2014","Class I","Finest Traditions, Broccoli Cauliflower Salad Base, 5/2.125 lb. , 10 733147 10647 8, 11/20/2013 - 12/9/2013 ","10 733147 10647 8, 11/20/2013 - 12/9/2013 ","."," 919,616.31 total pounds, for all products","Garden-Fresh Foods is recalling various cut vegetables, ready-to-eat salads, slaw, spread and dip products sold under various brands and code dates manufactured prior to November 06, 2013 because they may be contaminated with Listeria monocytogenes.",11/7/2013,"11/07/2013",12/26/2013,"12/26/2013"
"Food",66819,"Ongoing","Garden-Fresh Foods, Inc.","Milwaukee","WI","US","Voluntary: Firm Initiated","Press Release","IL, IN, MI, MN, MO, OH, PA, WI.","F-0876-2014","Class I","Garden-Fresh, Bread Pudding, 1/7 lb., 0 11596 75034 7, 11/21/2013 - 12/10/2013 ","0 11596 75034 7, 11/21/2013 - 12/10/2013 ","."," 919,616.31 total pounds, for all products","Garden-Fresh Foods is recalling various cut vegetables, ready-to-eat salads, slaw, spread and dip products sold under various brands and code dates manufactured prior to November 06, 2013 because they may be contaminated with Listeria monocytogenes.",11/7/2013,"11/07/2013",12/26/2013,"12/26/2013"
"Food",66819,"Ongoing","Garden-Fresh Foods, Inc.","Milwaukee","WI","US","Voluntary: Firm Initiated","Press Release","IL, IN, MI, MN, MO, OH, PA, WI.","F-0982-2014","Class I","Garden-Fresh, Lite Italian Pasta Salad, 1/5 lb., 0 11596 55208 8,11/22/2013 - 12/10/2013 ","0 11596 55208 8 11/22/2013 - 12/10/2013 ","."," 919,616.31 total pounds, for all products","Garden-Fresh Foods is recalling various cut vegetables, ready-to-eat salads, slaw, spread and dip products sold under various brands and code dates manufactured prior to November 06, 2013 because they may be contaminated with Listeria monocytogenes.",11/7/2013,"11/07/2013",12/26/2013,"12/26/2013"
"Food",66819,"Ongoing","Garden-Fresh Foods, Inc.","Milwaukee","WI","US","Voluntary: Firm Initiated","Press Release","IL, IN, MI, MN, MO, OH, PA, WI.","F-0872-2014","Class I","Grandpa's, Black Bean Salsa, 1/5 lb. , 0 11596 55917 9, 12/7/2013; Roundy's, Black Bean Salsa,12/15 oz., 0 11596 06118 4, 0 11596 06118 4, 12/1/2013 - 12/9/2013 ;"," 0 11596 55917 9, 12/7/2013; 0 11596 06118 4, 0 11596 06118 4, 12/1/2013 - 12/9/2013 ;","."," 919,616.31 total pounds, for all products","Garden-Fresh Foods is recalling various cut vegetables, ready-to-eat salads, slaw, spread and dip products sold under various brands and code dates manufactured prior to November 06, 2013 because they may be contaminated with Listeria monocytogenes.",11/7/2013,"11/07/2013",12/26/2013,"12/26/2013"
"Food",66819,"Ongoing","Garden-Fresh Foods, Inc.","Milwaukee","WI","US","Voluntary: Firm Initiated","Press Release","IL, IN, MI, MN, MO, OH, PA, WI.","F-0932-2014","Class I","Garden-Fresh, Dixie Cole Slaw, 2/5 lb. 0 11596 93007 7, 11/21/2013 - 12/7/2013 ","0 11596 93007 7, 11/21/2013 - 12/7/2013 ","."," 919,616.31 total pounds, for all products","Garden-Fresh Foods is recalling various cut vegetables, ready-to-eat salads, slaw, spread and dip products sold under various brands and code dates manufactured prior to November 06, 2013 because they may be contaminated with Listeria monocytogenes.",11/7/2013,"11/07/2013",12/26/2013,"12/26/2013"
"Food",66819,"Ongoing","Garden-Fresh Foods, Inc.","Milwaukee","WI","US","Voluntary: Firm Initiated","Press Release","IL, IN, MI, MN, MO, OH, PA, WI.","F-0870-2014","Class I","Garden-Fresh, Beet & Onion Salad, 1/5 lb., 0 11596 52018 2 , 11/21/2013 - 12/5/2013 ","0 11596 52018 2 , 11/21/2013 - 12/5/2013 ","."," 919,616.31 total pounds, for all products","Garden-Fresh Foods is recalling various cut vegetables, ready-to-eat salads, slaw, spread and dip products sold under various brands and code dates manufactured prior to November 06, 2013 because they may be contaminated with Listeria monocytogenes.",11/7/2013,"11/07/2013",12/26/2013,"12/26/2013"
"Food",66819,"Ongoing","Garden-Fresh Foods, Inc.","Milwaukee","WI","US","Voluntary: Firm Initiated","Press Release","IL, IN, MI, MN, MO, OH, PA, WI.","F-1076-2014","Class I","Garden-Fresh, Tomato Wedges, 1/3 lb., 0 11596 50574 9, 10/28/2013; Garden-Fresh, Tomatoes Diced , 2/2.5 lb., 0 11596 50572 5, 10/31/2013; Garden-Fresh, Tomatoes Sliced 1/4'', 2/2.5 lb., 0 11596 50571 8, 11/5/2013 - 11/13/2013; ","0 11596 50574 9 10/28/2013; 0 11596 50572 5 10/31/2013; 0 11596 50571 8 11/5/2013 - 11/13/2013; ","."," 919,616.31 total pounds, for all products","Garden-Fresh Foods is recalling various cut vegetables, ready-to-eat salads, slaw, spread and dip products sold under various brands and code dates manufactured prior to November 06, 2013 because they may be contaminated with Listeria monocytogenes.",11/7/2013,"11/07/2013",12/26/2013,"12/26/2013"
"Food",66819,"Ongoing","Garden-Fresh Foods, Inc.","Milwaukee","WI","US","Voluntary: Firm Initiated","Press Release","IL, IN, MI, MN, MO, OH, PA, WI.","F-1063-2014","Class I","Finest Traditions, Strawberry Creme Dessert, 1/8 lb., 10 733147 00021 9, 11/11/2013 - 11/25/2013; ","10 733147 00021 9, 11/11/2013 - 11/25/2013; ","."," 919,616.31 total pounds, for all products","Garden-Fresh Foods is recalling various cut vegetables, ready-to-eat salads, slaw, spread and dip products sold under various brands and code dates manufactured prior to November 06, 2013 because they may be contaminated with Listeria monocytogenes.",11/7/2013,"11/07/2013",12/26/2013,"12/26/2013"
"Food",66819,"Ongoing","Garden-Fresh Foods, Inc.","Milwaukee","WI","US","Voluntary: Firm Initiated","Press Release","IL, IN, MI, MN, MO, OH, PA, WI.","F-1079-2014","Class I","Weis, Tuna Salad, 9/8 oz., 0 41497 05345 2, 0 00 41497 05345 2, 11/26/2013 - 12/9/2013; ","0 00 41497 05345 2, 11/26/2013 - 12/9/2013; ","."," 919,616.31 total pounds, for all products","Garden-Fresh Foods is recalling various cut vegetables, ready-to-eat salads, slaw, spread and dip products sold under various brands and code dates manufactured prior to November 06, 2013 because they may be contaminated with Listeria monocytogenes.",11/7/2013,"11/07/2013",12/26/2013,"12/26/2013"
"Food",66819,"Ongoing","Garden-Fresh Foods, Inc.","Milwaukee","WI","US","Voluntary: Firm Initiated","Press Release","IL, IN, MI, MN, MO, OH, PA, WI.","F-1090-2014","Class I","Garden-Fresh, Wheat Berry Salad, 1/5 lb., 0 11596 52118 3, 11/10/2013 - 11/18/2013; ","0 11596 52118 3, 11/10/2013 - 11/18/2013","."," 919,616.31 total pounds, for all products","Garden-Fresh Foods is recalling various cut vegetables, ready-to-eat salads, slaw, spread and dip products sold under various brands and code dates manufactured prior to November 06, 2013 because they may be contaminated with Listeria monocytogenes.",11/7/2013,"11/07/2013",12/26/2013,"12/26/2013"
"Food",66819,"Ongoing","Garden-Fresh Foods, Inc.","Milwaukee","WI","US","Voluntary: Firm Initiated","Press Release","IL, IN, MI, MN, MO, OH, PA, WI.","F-0862-2014","Class I","Garden-Fresh, Bacon Mac & Cheddar Kit, 1/5.75 lb., 0 11596 62209 5, 11/21/2103 - 12/6/2013 ","0 11596 62209 5, 11/21/2103 - 12/6/2013","."," 919,616.31 total pounds, for all products","Garden-Fresh Foods is recalling various cut vegetables, ready-to-eat salads, slaw, spread and dip products sold under various brands and code dates manufactured prior to November 06, 2013 because they may be contaminated with Listeria monocytogenes.",11/7/2013,"11/07/2013",12/26/2013,"12/26/2013"
"Food",66819,"Ongoing","Garden-Fresh Foods, Inc.","Milwaukee","WI","US","Voluntary: Firm Initiated","Press Release","IL, IN, MI, MN, MO, OH, PA, WI.","F-0858-2014","Class I","Finest Traditions, Apple Salad Base 1/2.5 lb., 10 733147 11020 8 11/27/2013; Garden-Fresh, Apple Salad Base, 1/2.5 lb., 0 11596 25057 1 11/21/2013 - 12/9/2013 ","10 733147 11020 8 11/27/2013; 0 11596 25057 1 11/21/2013 - 12/9/2013 ","."," 919,616.31 total pounds, for all products","Garden-Fresh Foods is recalling various cut vegetables, ready-to-eat salads, slaw, spread and dip products sold under various brands and code dates manufactured prior to November 06, 2013 because they may be contaminated with Listeria monocytogenes.",11/7/2013,"11/07/2013",12/26/2013,"12/26/2013"
"Food",66819,"Ongoing","Garden-Fresh Foods, Inc.","Milwaukee","WI","US","Voluntary: Firm Initiated","Press Release","IL, IN, MI, MN, MO, OH, PA, WI.","F-0856-2014","Class I","Garden-Fresh, Anti Pasto Salad Kit, 1/6 lb., 0 11596 65634 2, 11/8/2013 - 11/11/2013 ","0 11596 65634 2, 11/8/2013 - 11/11/2013 ","."," 919,616.31 total pounds, for all products","Garden-Fresh Foods is recalling various cut vegetables, ready-to-eat salads, slaw, spread and dip products sold under various brands and code dates manufactured prior to November 06, 2013 because they may be contaminated with Listeria monocytogenes.",11/7/2013,"11/07/2013",12/26/2013,"12/26/2013"
"Food",66819,"Ongoing","Garden-Fresh Foods, Inc.","Milwaukee","WI","US","Voluntary: Firm Initiated","Press Release","IL, IN, MI, MN, MO, OH, PA, WI.","F-1092-2014","Class I","Maggie's, White Fruit Dip, 6/12 oz., 0 11596 06200 6, 0 00 11596 06200 6, 11/20/2013 - 12/4/2013; ","0 11596 06200 6, 0 00 11596 06200 6, 11/20/2013 - 12/4/2013; ; ","."," 919,616.31 total pounds, for all products","Garden-Fresh Foods is recalling various cut vegetables, ready-to-eat salads, slaw, spread and dip products sold under various brands and code dates manufactured prior to November 06, 2013 because they may be contaminated with Listeria monocytogenes.",11/7/2013,"11/07/2013",12/26/2013,"12/26/2013"
"Food",66819,"Ongoing","Garden-Fresh Foods, Inc.","Milwaukee","WI","US","Voluntary: Firm Initiated","Press Release","IL, IN, MI, MN, MO, OH, PA, WI.","F-0853-2014","Class I","Garden-Fresh, Amish Country Potato Salad, 2/5 lb., 0 11596 51005 7 11/22/2013 - 12/9/2013 ","0 11596 51005 7 11/22/2013 - 12/9/2013 ","."," 919,616.31 total pounds, for all products","Garden-Fresh Foods is recalling various cut vegetables, ready-to-eat salads, slaw, spread and dip products sold under various brands and code dates manufactured prior to November 06, 2013 because they may be contaminated with Listeria monocytogenes.",11/7/2013,"11/07/2013",12/26/2013,"12/26/2013"
"Food",66819,"Ongoing","Garden-Fresh Foods, Inc.","Milwaukee","WI","US","Voluntary: Firm Initiated","Press Release","IL, IN, MI, MN, MO, OH, PA, WI.","F-0851-2014","Class I","Garden-Fresh, Amish Country Macaroni Salad, 2/5 lb., 0 11596 52010 0 11/22/2013 - 12/6/2013 ","0 11596 52010 0 11/22/2013 - 12/6/2013 ","."," 919,616.31 total pounds, for all products","Garden-Fresh Foods is recalling various cut vegetables, ready-to-eat salads, slaw, spread and dip products sold under various brands and code dates manufactured prior to November 06, 2013 because they may be contaminated with Listeria monocytogenes.",11/7/2013,"11/07/2013",12/26/2013,"12/26/2013"
"Food",66819,"Ongoing","Garden-Fresh Foods, Inc.","Milwaukee","WI","US","Voluntary: Firm Initiated","Press Release","IL, IN, MI, MN, MO, OH, PA, WI.","F-1032-2014","Class I","Garden-Fresh, Rocky Road Dessert, 1/4 lb., 0 11596 45029 2, 11/26/2013 - 11/29/2013; ","0 11596 45029 2, 11/26/2013 - 11/29/2013; ; ","."," 919,616.31 total pounds, for all products","Garden-Fresh Foods is recalling various cut vegetables, ready-to-eat salads, slaw, spread and dip products sold under various brands and code dates manufactured prior to November 06, 2013 because they may be contaminated with Listeria monocytogenes.",11/7/2013,"11/07/2013",12/26/2013,"12/26/2013"
"Food",66819,"Ongoing","Garden-Fresh Foods, Inc.","Milwaukee","WI","US","Voluntary: Firm Initiated","Press Release","IL, IN, MI, MN, MO, OH, PA, WI.","F-0849-2014","Class I","Garden-Fresh, Amish Country Baked Beans, 2/5 lb., 0 11596 55186 9 11/21/2013 - 12/9/2013 ","0 11596 55186 9 11/21/2013 - 12/9/2013 ","."," 919,616.31 total pounds, for all products","Garden-Fresh Foods is recalling various cut vegetables, ready-to-eat salads, slaw, spread and dip products sold under various brands and code dates manufactured prior to November 06, 2013 because they may be contaminated with Listeria monocytogenes.",11/7/2013,"11/07/2013",12/26/2013,"12/26/2013"
"Food",66819,"Ongoing","Garden-Fresh Foods, Inc.","Milwaukee","WI","US","Voluntary: Firm Initiated","Press Release","IL, IN, MI, MN, MO, OH, PA, WI.","F-0846-2014","Class I","Garden-Fresh, 1/4'' x 1'' Red Pepper Sticks, 2/2 lb., 0 11596 40585 8 11/9/2013-11/11/2013 "," 11/9/2013-11/11/2013 ","."," 919,616.31 total pounds, for all products","Garden-Fresh Foods is recalling various cut vegetables, ready-to-eat salads, slaw, spread and dip products sold under various brands and code dates manufactured prior to November 06, 2013 because they may be contaminated with Listeria monocytogenes.",11/7/2013,"11/07/2013",12/26/2013,"12/26/2013"
"Food",66819,"Ongoing","Garden-Fresh Foods, Inc.","Milwaukee","WI","US","Voluntary: Firm Initiated","Press Release","IL, IN, MI, MN, MO, OH, PA, WI.","F-0845-2014","Class I","Garden-Fresh,,1/4'' x 1'' Green Pepper Sticks, 2/2 lb., 0 11596 40586 5 11/9/2013-11/11/2013; Garden-Fresh, Green Pepper Sticks 3/16'' , 1/15 lb. , 0 11596 55835 6 11/5/2013 Garden-Fresh, Green Peppers Diced 3/8'', 1/5 lb., 0 11596 50549 7 , 10/31/2013 - 11/5/2013 ","10 11596 40586 5 1/9/2013-11/11/2013; 0 11596 55835 6 11/5/2013; 0 11596 50549 7 , 10/31/2013 - 11/5/2013 ","."," 919,616.31 total pounds, for all products","Garden-Fresh Foods is recalling various cut vegetables, ready-to-eat salads, slaw, spread and dip products sold under various brands and code dates manufactured prior to November 06, 2013 because they may be contaminated with Listeria monocytogenes.",11/7/2013,"11/07/2013",12/26/2013,"12/26/2013"
"Food",66819,"Ongoing","Garden-Fresh Foods, Inc.","Milwaukee","WI","US","Voluntary: Firm Initiated","Press Release","IL, IN, MI, MN, MO, OH, PA, WI.","F-1060-2014","Class I","Copperwood Kitchens, Steakhouse Macaroni Salad, 2/5 lb., 8 11839 01018 0, 12/5/2013 ","8 11839 01018 0, 12/5/2013 ","."," 919,616.31 total pounds, for all products","Garden-Fresh Foods is recalling various cut vegetables, ready-to-eat salads, slaw, spread and dip products sold under various brands and code dates manufactured prior to November 06, 2013 because they may be contaminated with Listeria monocytogenes.",11/7/2013,"11/07/2013",12/26/2013,"12/26/2013"
"Food",66819,"Ongoing","Garden-Fresh Foods, Inc.","Milwaukee","WI","US","Voluntary: Firm Initiated","Press Release","IL, IN, MI, MN, MO, OH, PA, WI.","F-0915-2014","Class I","Garden-Fresh, Cranberry Orange Relish, 2/5 lb. , 0 11596 55094 7, 12/31/2014; Garden-Fresh, Cranberry Orange Relish, 6/16 oz., 0 11596 17092 3, 0 00 11596 17092 3, 12/31/2014;","0 11596 55094 7, 12/31/2014; 0 11596 17092 3, 0 00 11596 17092 3, 12/31/2014;","."," 919,616.31 total pounds, for all products","Garden-Fresh Foods is recalling various cut vegetables, ready-to-eat salads, slaw, spread and dip products sold under various brands and code dates manufactured prior to November 06, 2013 because they may be contaminated with Listeria monocytogenes.",11/7/2013,"11/07/2013",12/26/2013,"12/26/2013"
"Food",66819,"Ongoing","Garden-Fresh Foods, Inc.","Milwaukee","WI","US","Voluntary: Firm Initiated","Press Release","IL, IN, MI, MN, MO, OH, PA, WI.","F-0852-2014","Class I","Garden-Fresh, Amish Country Mustard Potato Salad, 2/5 lb., 0 11596 51015 6 11/22/2013 - 12/9/2013 ","0 11596 51015 6 11/22/2013 - 12/9/2013 ","."," 919,616.31 total pounds, for all products","Garden-Fresh Foods is recalling various cut vegetables, ready-to-eat salads, slaw, spread and dip products sold under various brands and code dates manufactured prior to November 06, 2013 because they may be contaminated with Listeria monocytogenes.",11/7/2013,"11/07/2013",12/26/2013,"12/26/2013"
"Food",66819,"Ongoing","Garden-Fresh Foods, Inc.","Milwaukee","WI","US","Voluntary: Firm Initiated","Press Release","IL, IN, MI, MN, MO, OH, PA, WI.","F-1000-2014","Class I","Garden-Fresh, Peeled & Sliced Cucumbers, 1/7 lb., 0 11596 70582 8, 11/11/2013; ","0 11596 70582 8, 11/11/2013; ","."," 919,616.31 total pounds, for all products","Garden-Fresh Foods is recalling various cut vegetables, ready-to-eat salads, slaw, spread and dip products sold under various brands and code dates manufactured prior to November 06, 2013 because they may be contaminated with Listeria monocytogenes.",11/7/2013,"11/07/2013",12/26/2013,"12/26/2013"
"Food",66819,"Ongoing","Garden-Fresh Foods, Inc.","Milwaukee","WI","US","Voluntary: Firm Initiated","Press Release","IL, IN, MI, MN, MO, OH, PA, WI.","F-1093-2014","Class I","Rogge's, White Potato Salad, 2/5 lb., 0 11596 51052 1, 11/17/2013 - 12/4/2013; ","0 11596 51052 1, 11/17/2013 - 12/4/2013; ","."," 919,616.31 total pounds, for all products","Garden-Fresh Foods is recalling various cut vegetables, ready-to-eat salads, slaw, spread and dip products sold under various brands and code dates manufactured prior to November 06, 2013 because they may be contaminated with Listeria monocytogenes.",11/7/2013,"11/07/2013",12/26/2013,"12/26/2013"
"Food",66819,"Ongoing","Garden-Fresh Foods, Inc.","Milwaukee","WI","US","Voluntary: Firm Initiated","Press Release","IL, IN, MI, MN, MO, OH, PA, WI.","F-1034-2014","Class II","Roundy's, Salsa, 12/15 oz., 0 11596 06117 7, 0 11596 06117 7, 12/1/2013 - 12/9/2013; ","0 11596 06117 7, 0 11596 06117 7, 12/1/2013 - 12/9/2013; ; ","."," 919,616.31 total pounds, for all products","Garden-Fresh Foods is recalling various cut vegetables, ready-to-eat salads, slaw, spread and dip products sold under various brands and code dates manufactured prior to November 06, 2013 because they may be contaminated with Listeria monocytogenes.",11/7/2013,"11/07/2013",12/26/2013,"12/26/2013"
"Food",66819,"Ongoing","Garden-Fresh Foods, Inc.","Milwaukee","WI","US","Voluntary: Firm Initiated","Press Release","IL, IN, MI, MN, MO, OH, PA, WI.","F-0952-2014","Class I","Garden-Fresh, Garden Salad Kit, 1/3 lb,. 0 11596 30177 8, 11/9/2013 - 11/14/2013; ","0 11596 30177 8, 11/9/2013 - 11/14/2013; ","."," 919,616.31 total pounds, for all products","Garden-Fresh Foods is recalling various cut vegetables, ready-to-eat salads, slaw, spread and dip products sold under various brands and code dates manufactured prior to November 06, 2013 because they may be contaminated with Listeria monocytogenes.",11/7/2013,"11/07/2013",12/26/2013,"12/26/2013"
"Food",66819,"Ongoing","Garden-Fresh Foods, Inc.","Milwaukee","WI","US","Voluntary: Firm Initiated","Press Release","IL, IN, MI, MN, MO, OH, PA, WI.","F-0895-2014","Class I","Garden-Fresh, Cheese Tortellini Salad Toscana, 1/5 lb., 0 11596 52075 9, 11/2/2013 - 12/10/2013 ","0 11596 52075 9, 11/2/2013 - 12/10/2013 ","."," 919,616.31 total pounds, for all products","Garden-Fresh Foods is recalling various cut vegetables, ready-to-eat salads, slaw, spread and dip products sold under various brands and code dates manufactured prior to November 06, 2013 because they may be contaminated with Listeria monocytogenes.",11/7/2013,"11/07/2013",12/26/2013,"12/26/2013"
"Food",66819,"Ongoing","Garden-Fresh Foods, Inc.","Milwaukee","WI","US","Voluntary: Firm Initiated","Press Release","IL, IN, MI, MN, MO, OH, PA, WI.","F-1028-2014","Class I","Finest Traditions, Rigatoni Pasta Salad, 1/8 lb., 10 733147 10148 0, 11/25/2013 - 12/9/2013; ","10 733147 10148 0, 11/25/2013 - 12/9/2013; ; ","."," 919,616.31 total pounds, for all products","Garden-Fresh Foods is recalling various cut vegetables, ready-to-eat salads, slaw, spread and dip products sold under various brands and code dates manufactured prior to November 06, 2013 because they may be contaminated with Listeria monocytogenes.",11/7/2013,"11/07/2013",12/26/2013,"12/26/2013"
"Food",66819,"Ongoing","Garden-Fresh Foods, Inc.","Milwaukee","WI","US","Voluntary: Firm Initiated","Press Release","IL, IN, MI, MN, MO, OH, PA, WI.","F-0950-2014","Class I","Finest Traditions, Fruit Dip, 6/11 oz., 10 733147 10853 3 12/20/2013 - 12/27/2013 ","10 733147 10853 3 12/20/2013 - 12/27/2013 ","."," 919,616.31 total pounds, for all products","Garden-Fresh Foods is recalling various cut vegetables, ready-to-eat salads, slaw, spread and dip products sold under various brands and code dates manufactured prior to November 06, 2013 because they may be contaminated with Listeria monocytogenes.",11/7/2013,"11/07/2013",12/26/2013,"12/26/2013"
"Food",66819,"Ongoing","Garden-Fresh Foods, Inc.","Milwaukee","WI","US","Voluntary: Firm Initiated","Press Release","IL, IN, MI, MN, MO, OH, PA, WI.","F-0912-2014","Class I","Grandpa's, Crab Like Cheese Ball, 1/5 lb., 0 11596 55906 3, 11/28/2013 ","0 11596 55906 3, 11/28/2013 ","."," 919,616.31 total pounds, for all products","Garden-Fresh Foods is recalling various cut vegetables, ready-to-eat salads, slaw, spread and dip products sold under various brands and code dates manufactured prior to November 06, 2013 because they may be contaminated with Listeria monocytogenes.",11/7/2013,"11/07/2013",12/26/2013,"12/26/2013"
"Food",66819,"Ongoing","Garden-Fresh Foods, Inc.","Milwaukee","WI","US","Voluntary: Firm Initiated","Press Release","IL, IN, MI, MN, MO, OH, PA, WI.","F-0976-2014","Class I","Dairy Fresh, Krab Salad, 1/5 lb., 0 70163 41001 5, 12/8/2013 - 12/14/2013; Finest Traditions, Krab Salad, 1/8 lb., 10 733147 10172 5, 11/18/2013 - 12/2/2013; Rogge's, Krab Salad 2/5 lb., 0 11596 55110 4, 11/22/2013 - 12/9/2013; ","0 70163 41001 5 12/8/2013 - 12/14/2013; 10 733147 10172 5 11/18/2013 - 12/2/2013; 0 11596 55110 4 11/22/2013 - 12/9/2013 ;","."," 919,616.31 total pounds, for all products","Garden-Fresh Foods is recalling various cut vegetables, ready-to-eat salads, slaw, spread and dip products sold under various brands and code dates manufactured prior to November 06, 2013 because they may be contaminated with Listeria monocytogenes.",11/7/2013,"11/07/2013",12/26/2013,"12/26/2013"
"Food",66819,"Ongoing","Garden-Fresh Foods, Inc.","Milwaukee","WI","US","Voluntary: Firm Initiated","Press Release","IL, IN, MI, MN, MO, OH, PA, WI.","F-0886-2014","Class I","Garden-Fresh, Cabbage Shredded with Carrot 1/8'', 4/5 lb., 0 11596 50105 5, 10/30/2013 ; Martin's, Cabbage Shredded with Carrot 1/8'', 2/4 lb., 0 11596 50112 3 , 11/13/2013 - 11/20/2013 ","0 11596 50105 5, 10/30/2013 ; 0 11596 50112 3 , 11/13/2013 - 11/20/2013 ","."," 919,616.31 total pounds, for all products","Garden-Fresh Foods is recalling various cut vegetables, ready-to-eat salads, slaw, spread and dip products sold under various brands and code dates manufactured prior to November 06, 2013 because they may be contaminated with Listeria monocytogenes.",11/7/2013,"11/07/2013",12/26/2013,"12/26/2013"
"Food",66819,"Ongoing","Garden-Fresh Foods, Inc.","Milwaukee","WI","US","Voluntary: Firm Initiated","Press Release","IL, IN, MI, MN, MO, OH, PA, WI.","F-0985-2014","Class I","Garden-Fresh, Mediterranean Pasta Salad, 1/5 lb., 0 11596 52071 1, 12/4/2103 - 12/10/2013, ","0 11596 52071 1, 12/4/2103 - 12/10/2013, ","."," 919,616.31 total pounds, for all products","Garden-Fresh Foods is recalling various cut vegetables, ready-to-eat salads, slaw, spread and dip products sold under various brands and code dates manufactured prior to November 06, 2013 because they may be contaminated with Listeria monocytogenes.",11/7/2013,"11/07/2013",12/26/2013,"12/26/2013"
"Food",66819,"Ongoing","Garden-Fresh Foods, Inc.","Milwaukee","WI","US","Voluntary: Firm Initiated","Press Release","IL, IN, MI, MN, MO, OH, PA, WI.","F-0919-2014","Class II","Garden-Fresh, Creamy Cole Slaw Dressing, 4/2 lb., 0 11596 43200 7, 12/17/2013 - 12/27/2013 ","0 11596 43200 7, 12/17/2013 - 12/27/2013 ","."," 919,616.31 total pounds, for all products","Garden-Fresh Foods is recalling various cut vegetables, ready-to-eat salads, slaw, spread and dip products sold under various brands and code dates manufactured prior to November 06, 2013 because they may be contaminated with Listeria monocytogenes.",11/7/2013,"11/07/2013",12/26/2013,"12/26/2013"
"Food",66819,"Ongoing","Garden-Fresh Foods, Inc.","Milwaukee","WI","US","Voluntary: Firm Initiated","Press Release","IL, IN, MI, MN, MO, OH, PA, WI.","F-0993-2014","Class I","Martin's, Oriental Cabbage Kit, 1/10 lb., 0 11596 53050 5, 11/9/2013 - 11/11/2013; ","0 11596 53050 5, 11/9/2013 - 11/11/2013; ","."," 919,616.31 total pounds, for all products","Garden-Fresh Foods is recalling various cut vegetables, ready-to-eat salads, slaw, spread and dip products sold under various brands and code dates manufactured prior to November 06, 2013 because they may be contaminated with Listeria monocytogenes.",11/7/2013,"11/07/2013",12/26/2013,"12/26/2013"
"Food",66819,"Ongoing","Garden-Fresh Foods, Inc.","Milwaukee","WI","US","Voluntary: Firm Initiated","Press Release","IL, IN, MI, MN, MO, OH, PA, WI.","F-0963-2014","Class I","Garden-Fresh,Hawaiian Salad, 1/5 lb., 0 11596 55058 9, 11/25/2013 - 12/9/2013; Our Own, Hawaiian Salad, 1/4 lb, 0 11596 45068 1, 11/26/2013 - 12/9/2013; ","0 11596 55058 9, 11/25/2013 - 12/9/2013; 0 11596 45068 1, 11/26/2013 - 12/9/2013; ","."," 919,616.31 total pounds, for all products","Garden-Fresh Foods is recalling various cut vegetables, ready-to-eat salads, slaw, spread and dip products sold under various brands and code dates manufactured prior to November 06, 2013 because they may be contaminated with Listeria monocytogenes.",11/7/2013,"11/07/2013",12/26/2013,"12/26/2013"
"Food",66819,"Ongoing","Garden-Fresh Foods, Inc.","Milwaukee","WI","US","Voluntary: Firm Initiated","Press Release","IL, IN, MI, MN, MO, OH, PA, WI.","F-1045-2014","Class I","Rogge's, Sliced Extra Sweet Potato Salad, 2/5 lb., 0 11596 51054 5, 11/27/2013; ","0 11596 51054 5, 11/27/2013","."," 919,616.31 total pounds, for all products","Garden-Fresh Foods is recalling various cut vegetables, ready-to-eat salads, slaw, spread and dip products sold under various brands and code dates manufactured prior to November 06, 2013 because they may be contaminated with Listeria monocytogenes.",11/7/2013,"11/07/2013",12/26/2013,"12/26/2013"
"Food",66819,"Ongoing","Garden-Fresh Foods, Inc.","Milwaukee","WI","US","Voluntary: Firm Initiated","Press Release","IL, IN, MI, MN, MO, OH, PA, WI.","F-0920-2014","Class I","Finest Traditions, Creamy Country Cole Slaw, 1/8 lb., 10 733147 10140 4, 11/20/2013 - 12/4/2013 ","10 733147 10140 4, 11/20/2013 - 12/4/2013 ","."," 919,616.31 total pounds, for all products","Garden-Fresh Foods is recalling various cut vegetables, ready-to-eat salads, slaw, spread and dip products sold under various brands and code dates manufactured prior to November 06, 2013 because they may be contaminated with Listeria monocytogenes.",11/7/2013,"11/07/2013",12/26/2013,"12/26/2013"
"Food",66819,"Ongoing","Garden-Fresh Foods, Inc.","Milwaukee","WI","US","Voluntary: Firm Initiated","Press Release","IL, IN, MI, MN, MO, OH, PA, WI.","F-1013-2014","Class I","Garden-Fresh, Premium Potato Salad, 2/5 lb., 0 11596 91019 2, 11/22/2013 - 12/9/2013; Our Own, Premium Potato Salad, 4/5 lb., 0 11596 91045 1, 0 00 11596 91045 1, 11/20/2013 - 12/5/2013; ","0 11596 91019 2, 11/22/2013 - 12/9/2013; 0 11596 91045 1, 0 00 11596 91045 1, 11/20/2013 - 12/5/2013; ","."," 919,616.31 total pounds, for all products","Garden-Fresh Foods is recalling various cut vegetables, ready-to-eat salads, slaw, spread and dip products sold under various brands and code dates manufactured prior to November 06, 2013 because they may be contaminated with Listeria monocytogenes.",11/7/2013,"11/07/2013",12/26/2013,"12/26/2013"
"Food",66819,"Ongoing","Garden-Fresh Foods, Inc.","Milwaukee","WI","US","Voluntary: Firm Initiated","Press Release","IL, IN, MI, MN, MO, OH, PA, WI.","F-1071-2014","Class I","Finest Traditions, Taco Spread, 2/4 lb., 10 733147 11019 2, 12/18/2013 - 12/20/2013 Grandpa's, Taco Spread, 2/4 lb., 0 11596 55910 0, 12/24/2013 - 12/31/2013 ; ","10 733147 11019 2, 12/18/2013 - 12/20/2013; 0 11596 55910 0, 12/24/2013 - 12/31/2013 ; ","."," 919,616.31 total pounds, for all products","Garden-Fresh Foods is recalling various cut vegetables, ready-to-eat salads, slaw, spread and dip products sold under various brands and code dates manufactured prior to November 06, 2013 because they may be contaminated with Listeria monocytogenes.",11/7/2013,"11/07/2013",12/26/2013,"12/26/2013"
"Food",66819,"Ongoing","Garden-Fresh Foods, Inc.","Milwaukee","WI","US","Voluntary: Firm Initiated","Press Release","IL, IN, MI, MN, MO, OH, PA, WI.","F-0977-2014","Class I","Garden-Fresh, Layered Seafood Dip Base,,1/4 lb.,0 11596 55153 1, 11/21/2013 - 11/29/2013 ","0 11596 55153 1, 11/21/2013 - 11/29/2013 ","."," 919,616.31 total pounds, for all products","Garden-Fresh Foods is recalling various cut vegetables, ready-to-eat salads, slaw, spread and dip products sold under various brands and code dates manufactured prior to November 06, 2013 because they may be contaminated with Listeria monocytogenes.",11/7/2013,"11/07/2013",12/26/2013,"12/26/2013"
"Food",66819,"Ongoing","Garden-Fresh Foods, Inc.","Milwaukee","WI","US","Voluntary: Firm Initiated","Press Release","IL, IN, MI, MN, MO, OH, PA, WI.","F-0979-2014","Class I","Garden-Fresh, LCR Lettuce Tossed / Garni Bags, 4/5 lb., 0 11596 50150 5 ,11/4/2013 ","0 11596 50150 5 ,11/4/2013 ","."," 919,616.31 total pounds, for all products","Garden-Fresh Foods is recalling various cut vegetables, ready-to-eat salads, slaw, spread and dip products sold under various brands and code dates manufactured prior to November 06, 2013 because they may be contaminated with Listeria monocytogenes.",11/7/2013,"11/07/2013",12/26/2013,"12/26/2013"
"Food",66819,"Ongoing","Garden-Fresh Foods, Inc.","Milwaukee","WI","US","Voluntary: Firm Initiated","Press Release","IL, IN, MI, MN, MO, OH, PA, WI.","F-0859-2014","Class I","Grandpa's, Artichoke Spinach Dip, 1/5 lb., 0 11596 55902 5, 12/21/2013; Roundy's, Artichoke Spinach Dip, 6/12 oz. , 0 11596 06170 2, 0 00 11596 16170 9, 12/17/2013 - 12/24/2013 ","0 11596 55902 5= 12/21/2013; 0 11596 06170 2 = 0 00 11596 16170 9, 12/17/2013 - 12/24/2013 ","."," 919,616.31 total pounds, for all products","Garden-Fresh Foods is recalling various cut vegetables, ready-to-eat salads, slaw, spread and dip products sold under various brands and code dates manufactured prior to November 06, 2013 because they may be contaminated with Listeria monocytogenes.",11/7/2013,"11/07/2013",12/26/2013,"12/26/2013"
"Food",66819,"Ongoing","Garden-Fresh Foods, Inc.","Milwaukee","WI","US","Voluntary: Firm Initiated","Press Release","IL, IN, MI, MN, MO, OH, PA, WI.","F-0937-2014","Class I","Garden-Fresh, Farm Stand Pasta Salad, 1/5 lb., 0 11 11596 52204 9, 11/21/2103 - 12/6/2013 ","0 11 11596 52204 9 11/21/2103 - 12/6/2013 ","."," 919,616.31 total pounds, for all products","Garden-Fresh Foods is recalling various cut vegetables, ready-to-eat salads, slaw, spread and dip products sold under various brands and code dates manufactured prior to November 06, 2013 because they may be contaminated with Listeria monocytogenes.",11/7/2013,"11/07/2013",12/26/2013,"12/26/2013"
"Food",66819,"Ongoing","Garden-Fresh Foods, Inc.","Milwaukee","WI","US","Voluntary: Firm Initiated","Press Release","IL, IN, MI, MN, MO, OH, PA, WI.","F-0850-2014","Class I","Garden-Fresh, Amish Country Cole Slaw, 2/5 lb. , 0 11596 53010 9 11/21/2013 - 12/6/2013 ","0 11596 53010 9 11/21/2013 - 12/6/2013 ","."," 919,616.31 total pounds, for all products","Garden-Fresh Foods is recalling various cut vegetables, ready-to-eat salads, slaw, spread and dip products sold under various brands and code dates manufactured prior to November 06, 2013 because they may be contaminated with Listeria monocytogenes.",11/7/2013,"11/07/2013",12/26/2013,"12/26/2013"
"Food",66819,"Ongoing","Garden-Fresh Foods, Inc.","Milwaukee","WI","US","Voluntary: Firm Initiated","Press Release","IL, IN, MI, MN, MO, OH, PA, WI.","F-0924-2014","Class I","Grandpa's, Cucumber Dill Dip, 1/5 lb.,0 11596 55900 1, 12/23/2013- 12/28/2013 ","0 11596 55900 1, 12/23/2013- 12/28/2013 ","."," 919,616.31 total pounds, for all products","Garden-Fresh Foods is recalling various cut vegetables, ready-to-eat salads, slaw, spread and dip products sold under various brands and code dates manufactured prior to November 06, 2013 because they may be contaminated with Listeria monocytogenes.",11/7/2013,"11/07/2013",12/26/2013,"12/26/2013"
"Food",66819,"Ongoing","Garden-Fresh Foods, Inc.","Milwaukee","WI","US","Voluntary: Firm Initiated","Press Release","IL, IN, MI, MN, MO, OH, PA, WI.","F-0899-2014","Class I","Finest Traditions, Chipotle Potato Salad, 1/8 lb., 10 733147 10281 4, 11/20/2013 - 12/9/2013 ","10 733147 10281 4, 11/20/2013 - 12/9/2013 ","."," 919,616.31 total pounds, for all products","Garden-Fresh Foods is recalling various cut vegetables, ready-to-eat salads, slaw, spread and dip products sold under various brands and code dates manufactured prior to November 06, 2013 because they may be contaminated with Listeria monocytogenes.",11/7/2013,"11/07/2013",12/26/2013,"12/26/2013"
"Food",66819,"Ongoing","Garden-Fresh Foods, Inc.","Milwaukee","WI","US","Voluntary: Firm Initiated","Press Release","IL, IN, MI, MN, MO, OH, PA, WI.","F-0903-2014","Class I","Copperwood Kitchens, Chopped Cole Slaw, 2/5 lb., 8 11839 01020 3, 11/21/2013 - 12/4/2013; Dairy Fresh, Chopped Cole Slaw, 2/5 lb., 0 70163 57363 5, 12/1/2013; Family Style , Cole Slaw, 2/5 lb., 0 11596 53060 4, 11/26/2013 - 12/5/2013; Grandpa's, Cole Slaw, 2/5 lb., 0 11596 93021 3, 11/21/2013 - 12/7/2013; Grandpa's, Cole Slaw, 12/16 oz., 0 11596 14028 5, 0 11596 24028 2, 11/26/2013 - 12/6/2013; Grandpa's, Cole Slaw, 12/16 oz., 0 11596 14028 5, 0 11596 24028 2, 11/25/2013 - 12/3/2013; Grandpa's, Cole Slaw, 4/48 oz., 0 11596 34325 9, 0 00 11596 44325 6, 11/21/2013 - 12/7/2013; Grandpa's, Cole Slaw, 18/3.5 oz., 0 11596 08006 2, 0 00 11596 08006 2, 11/21/2013 - 12/5/2013; ","8 11839 01020 3 11/21/2013 - 12/4/2013 0 70163 57363 5 12/1/2013 0 11596 53060 4 11/26/2013 - 12/5/2013 0 11596 93021 3 11/21/2013 - 12/7/2013 0 11596 24028 2 11/26/2013 - 12/6/2013 0 11596 24028 2 11/25/2013 - 12/3/2013 0 00 11596 44325 6 11/21/2013 - 12/7/2013 0 00 11596 08006 2 11/21/2013 - 12/5/2013 ","."," 919,616.31 total pounds, for all products","Garden-Fresh Foods is recalling various cut vegetables, ready-to-eat salads, slaw, spread and dip products sold under various brands and code dates manufactured prior to November 06, 2013 because they may be contaminated with Listeria monocytogenes.",11/7/2013,"11/07/2013",12/26/2013,"12/26/2013"
"Food",66819,"Ongoing","Garden-Fresh Foods, Inc.","Milwaukee","WI","US","Voluntary: Firm Initiated","Press Release","IL, IN, MI, MN, MO, OH, PA, WI.","F-1046-2014","Class I","Finest Traditions, Smoked Imitation Salmon Spread, 1/8 lb., 10 733147 10120 6, 11/25/2013 - 12/9/2013; Finest Traditions, Smoked Imitation Salmon Spread, 6/12 oz., 7 33147 00127 1, 10 733147 10079 7, 11/25/2013 - 12/9/2013; ","10 733147 10120 6, 11/25/2013 - 12/9/2013; 7 33147 00127 1, 10 733147 10079 7, 11/25/2013 - 12/9/2013; ","."," 919,616.31 total pounds, for all products","Garden-Fresh Foods is recalling various cut vegetables, ready-to-eat salads, slaw, spread and dip products sold under various brands and code dates manufactured prior to November 06, 2013 because they may be contaminated with Listeria monocytogenes.",11/7/2013,"11/07/2013",12/26/2013,"12/26/2013"
"Food",66819,"Ongoing","Garden-Fresh Foods, Inc.","Milwaukee","WI","US","Voluntary: Firm Initiated","Press Release","IL, IN, MI, MN, MO, OH, PA, WI.","F-0942-2014","Class I","Grandpa's, Fresh Bruschetta, 1/5 lb.,0 11596 55911 7, 12/1/2013 - 12/16/2013 ","0 11596 55911 7, 12/1/2013 - 12/16/2013 ","."," 919,616.31 total pounds, for all products","Garden-Fresh Foods is recalling various cut vegetables, ready-to-eat salads, slaw, spread and dip products sold under various brands and code dates manufactured prior to November 06, 2013 because they may be contaminated with Listeria monocytogenes.",11/7/2013,"11/07/2013",12/26/2013,"12/26/2013"
"Food",66819,"Ongoing","Garden-Fresh Foods, Inc.","Milwaukee","WI","US","Voluntary: Firm Initiated","Press Release","IL, IN, MI, MN, MO, OH, PA, WI.","F-0923-2014","Class I","Garden-Fresh, Creamy Tuna Salad 2/5 lb., 0 11596 55108 1, 11/26/2013 - 12/10/2013 ","0 11596 55108 1, 11/26/2013 - 12/10/2013 ","."," 919,616.31 total pounds, for all products","Garden-Fresh Foods is recalling various cut vegetables, ready-to-eat salads, slaw, spread and dip products sold under various brands and code dates manufactured prior to November 06, 2013 because they may be contaminated with Listeria monocytogenes.",11/7/2013,"11/07/2013",12/26/2013,"12/26/2013"
"Food",66819,"Ongoing","Garden-Fresh Foods, Inc.","Milwaukee","WI","US","Voluntary: Firm Initiated","Press Release","IL, IN, MI, MN, MO, OH, PA, WI.","F-1038-2014","Class I","Finest Traditions, Seafood Salad Louie, 1/5 lb., 10 733147 10974 5, 11/20/2013 - 12/6/2013; ","10 733147 10974 5, 11/20/2013 - 12/6/2013; ; ","."," 919,616.31 total pounds, for all products","Garden-Fresh Foods is recalling various cut vegetables, ready-to-eat salads, slaw, spread and dip products sold under various brands and code dates manufactured prior to November 06, 2013 because they may be contaminated with Listeria monocytogenes.",11/7/2013,"11/07/2013",12/26/2013,"12/26/2013"
"Food",66819,"Ongoing","Garden-Fresh Foods, Inc.","Milwaukee","WI","US","Voluntary: Firm Initiated","Press Release","IL, IN, MI, MN, MO, OH, PA, WI.","F-0869-2014","Class I","Garden-Fresh, Baked Potato Salad Kit, 1/5.75 lb. , 0 11596 61071 9, 11/21/2013 - 12/6/2013; Marsh, Baked Potato Salad Kit, 1/5.75 lb., 0 11596 51083 5, 11/22/2013 - 12/6/2013 ","0 11596 61071 9, 11/21/2013 - 12/6/2013; 0 11596 51083 5, 11/22/2013 - 12/6/2013 ","."," 919,616.31 total pounds, for all products","Garden-Fresh Foods is recalling various cut vegetables, ready-to-eat salads, slaw, spread and dip products sold under various brands and code dates manufactured prior to November 06, 2013 because they may be contaminated with Listeria monocytogenes.",11/7/2013,"11/07/2013",12/26/2013,"12/26/2013"
"Food",66819,"Ongoing","Garden-Fresh Foods, Inc.","Milwaukee","WI","US","Voluntary: Firm Initiated","Press Release","IL, IN, MI, MN, MO, OH, PA, WI.","F-0900-2014","Class I","Garden-Fresh, Chipotle Ranch Potato Salad, 1/5 lb., 0 11596 51002 6, 11/28/2013 - 12/10/2013 ","0 11596 51002 6, 11/28/2013 - 12/10/2013 ","."," 919,616.31 total pounds, for all products","Garden-Fresh Foods is recalling various cut vegetables, ready-to-eat salads, slaw, spread and dip products sold under various brands and code dates manufactured prior to November 06, 2013 because they may be contaminated with Listeria monocytogenes.",11/7/2013,"11/07/2013",12/26/2013,"12/26/2013"
"Food",66819,"Ongoing","Garden-Fresh Foods, Inc.","Milwaukee","WI","US","Voluntary: Firm Initiated","Press Release","IL, IN, MI, MN, MO, OH, PA, WI.","F-1012-2014","Class I","Garden-Fresh, Premium Egg Salad,, 1/5 lb., 0 11596 52136 7, 11/16/2013 - 11/22/2013; ","0 11596 52136 7, 11/16/2013 - 11/22/2013; ","."," 919,616.31 total pounds, for all products","Garden-Fresh Foods is recalling various cut vegetables, ready-to-eat salads, slaw, spread and dip products sold under various brands and code dates manufactured prior to November 06, 2013 because they may be contaminated with Listeria monocytogenes.",11/7/2013,"11/07/2013",12/26/2013,"12/26/2013"
"Food",66819,"Ongoing","Garden-Fresh Foods, Inc.","Milwaukee","WI","US","Voluntary: Firm Initiated","Press Release","IL, IN, MI, MN, MO, OH, PA, WI.","F-0910-2014","Class I","Garden-Fresh, Cookies & Crme Mousse, 1/5 lb., 0 11596 55062 6, 0 00 11596 05062 1, 11/25/2013 - 12/9/2013 "," 0 11596 55062 6, 0 00 11596 05062 1, 11/25/2013 - 12/9/2013 ","."," 919,616.31 total pounds, for all products","Garden-Fresh Foods is recalling various cut vegetables, ready-to-eat salads, slaw, spread and dip products sold under various brands and code dates manufactured prior to November 06, 2013 because they may be contaminated with Listeria monocytogenes.",11/7/2013,"11/07/2013",12/26/2013,"12/26/2013"
"Food",66819,"Ongoing","Garden-Fresh Foods, Inc.","Milwaukee","WI","US","Voluntary: Firm Initiated","Press Release","IL, IN, MI, MN, MO, OH, PA, WI.","F-0905-2014","Class I","Weis, Creamy Cole Slaw, 4/3 lb., 0 41497 05906 5, 0 00 41497 05906 5, 11/21/2013 - 11/28/2013; Garden-Fresh, Creamy Cole Slaw, 4/8 lb.,0 11596 53005 5, 0 00 11596 53005 5, 11/26/2013 - 12/4/2013; Weis, Creamy Cole Slaw, 6/16 oz., 0 41497 05837 2, 0 00 41497 05837 2, 11/25/2013 - 12/3/2013; Weis, Creamy Cole Slaw, 2/5 lb., 0 11596 53101 4, 11/21/2013 - 12/3/2013; Garden-Fresh, Creamy Shredded Cole Slaw, 2/5 lb., 0 11596 93014 5, 11/21/2013 - 12/7/2013; Garden-Fresh, Creamy Shredded Cole Slaw, 12/16 oz., 0 11596 14022 3, 0 11596 14022 3, 11/21/213 - 12/6/2013; Garden-Fresh, Creamy Shredded Cole Slaw 8/32 oz., 0 11596 24203 3, 0 11596 24203 3, 11/25/2013 - 12/3/2013; Garden-Fresh, Creamy Shredded Cole Slaw, 6/48 oz., 0 11596 34309 9 0 11596 34309 9 11/27/2013 - 12/6/2013; Spartan, Creamy Shredded Cole Slaw, 6/16 oz., 0 11213 90322 4, 0 00 11213 90322 4, 11/25/2013 - 12/2/2013; Spartan, Creamy Shredded Cole Slaw, 4/48 oz.., 0 11213 90327 9, 0 00 11213 90327 9, 11/26/2013;; ","0 41497 05906 5, 0 00 41497 05906 5, 11/21/2013 - 11/28/2013; 0 11596 14022 3, 0 11596 14022 3, 11/21/213 - 12/6/2013; 0 11596 53005 5, 0 00 11596 53005 5, 11/26/2013 - 12/4/2013; 0 41497 05837 2, 0 00 41497 05837 2, 11/25/2013 - 12/3/2013; 0 11596 53101 4, 11/21/2013 - 12/3/2013; 0 11596 93014 5 11/21/2013 - 12/7/2013; 0 11596 14022 3 0 11596 14022 3 11/21/213 - 12/6/2013; 0 11596 24203 3 0 11596 24203 3 11/25/2013 - 12/3/2013; 0 11596 34309 9 0 11596 34309 9 11/27/2013 - 12/6/2013; 0 11213 90322 4 0 00 11213 90322 4 11/25/2013 - 12/2/2013; 0 11213 90327 9 0 00 11213 90327 9 11/26/2013 ;","."," 919,616.31 total pounds, for all products","Garden-Fresh Foods is recalling various cut vegetables, ready-to-eat salads, slaw, spread and dip products sold under various brands and code dates manufactured prior to November 06, 2013 because they may be contaminated with Listeria monocytogenes.",11/7/2013,"11/07/2013",12/26/2013,"12/26/2013"
"Food",66819,"Ongoing","Garden-Fresh Foods, Inc.","Milwaukee","WI","US","Voluntary: Firm Initiated","Press Release","IL, IN, MI, MN, MO, OH, PA, WI.","F-1049-2014","Class I","Finest Traditions, Sour Cream & Chive Potato Filling, 1/8 lb, 10 733147 10261 6, 11/11/2013 - 11/18/2013; ","10 733147 10261 6, 11/11/2013 - 11/18/2013; ","."," 919,616.31 total pounds, for all products","Garden-Fresh Foods is recalling various cut vegetables, ready-to-eat salads, slaw, spread and dip products sold under various brands and code dates manufactured prior to November 06, 2013 because they may be contaminated with Listeria monocytogenes.",11/7/2013,"11/07/2013",12/26/2013,"12/26/2013"
"Food",66819,"Ongoing","Garden-Fresh Foods, Inc.","Milwaukee","WI","US","Voluntary: Firm Initiated","Press Release","IL, IN, MI, MN, MO, OH, PA, WI.","F-1062-2014","Class I","Garden-Fresh, Steakhouse Potato Salad Kit, 1/10.75 lb. , 0 11596 51076 7, 11/21/2013 - 12/7/2013 ","0 11596 51076 7, 11/21/2013 - 12/7/2013 ","."," 919,616.31 total pounds, for all products","Garden-Fresh Foods is recalling various cut vegetables, ready-to-eat salads, slaw, spread and dip products sold under various brands and code dates manufactured prior to November 06, 2013 because they may be contaminated with Listeria monocytogenes.",11/7/2013,"11/07/2013",12/26/2013,"12/26/2013"
"Food",66819,"Ongoing","Garden-Fresh Foods, Inc.","Milwaukee","WI","US","Voluntary: Firm Initiated","Press Release","IL, IN, MI, MN, MO, OH, PA, WI.","F-0941-2014","Class I","Garden-Fresh, Fresh Creamy Cole Slaw Kit, 2/6 lb., 0 11596 63039 7, 11/8/2013 - 11/15/2013 ","0 11596 63039 7, 11/8/2013 - 11/15/2013 ","."," 919,616.31 total pounds, for all products","Garden-Fresh Foods is recalling various cut vegetables, ready-to-eat salads, slaw, spread and dip products sold under various brands and code dates manufactured prior to November 06, 2013 because they may be contaminated with Listeria monocytogenes.",11/7/2013,"11/07/2013",12/26/2013,"12/26/2013"
"Food",66819,"Ongoing","Garden-Fresh Foods, Inc.","Milwaukee","WI","US","Voluntary: Firm Initiated","Press Release","IL, IN, MI, MN, MO, OH, PA, WI.","F-0954-2014","Class I","Grandpa's Garlic Herb Spread, 1/5 lb., 0 11596 55907 0, 11/21/2013 - 11/29/2013 ","0 11596 55907 0, 11/21/2013 - 11/29/2013 ","."," 919,616.31 total pounds, for all products","Garden-Fresh Foods is recalling various cut vegetables, ready-to-eat salads, slaw, spread and dip products sold under various brands and code dates manufactured prior to November 06, 2013 because they may be contaminated with Listeria monocytogenes.",11/7/2013,"11/07/2013",12/26/2013,"12/26/2013"
"Food",66819,"Ongoing","Garden-Fresh Foods, Inc.","Milwaukee","WI","US","Voluntary: Firm Initiated","Press Release","IL, IN, MI, MN, MO, OH, PA, WI.","F-0934-2014","Class I","Finest Traditions, Egg Salad Spread, 2/4 lb., 10 733147 10189 3, 11/15/2013 - 12/4/2013; Finest Traditions, Egg Salad Spread, 6/12 oz., 7 33147 10491 0 10 733147 10492 4, 11/15/2013 - 12/7/2013; Garden-Fresh, Egg Salad Spread, 1/5 lb., 0 11596 55168 5, 11/22/2013 - 11/30/2013; ","10 733147 10189 3 11/15/2013 - 12/4/2013; 10 733147 10492 4 11/15/2013 - 12/7/2013; 0 11596 55168 5 11/22/2013 - 11/30/2013 ;","."," 919,616.31 total pounds, for all products","Garden-Fresh Foods is recalling various cut vegetables, ready-to-eat salads, slaw, spread and dip products sold under various brands and code dates manufactured prior to November 06, 2013 because they may be contaminated with Listeria monocytogenes.",11/7/2013,"11/07/2013",12/26/2013,"12/26/2013"
"Food",66819,"Ongoing","Garden-Fresh Foods, Inc.","Milwaukee","WI","US","Voluntary: Firm Initiated","Press Release","IL, IN, MI, MN, MO, OH, PA, WI.","F-0897-2014","Class I","Martin's, Chef/Cobb Salad Kit, 1/4.625 lb.,0 11596 50180 2, 11/9/2013 - 11/16/2013 ","0 11596 50180 2, 11/9/2013 - 11/16/2013 ","."," 919,616.31 total pounds, for all products","Garden-Fresh Foods is recalling various cut vegetables, ready-to-eat salads, slaw, spread and dip products sold under various brands and code dates manufactured prior to November 06, 2013 because they may be contaminated with Listeria monocytogenes.",11/7/2013,"11/07/2013",12/26/2013,"12/26/2013"
"Food",66819,"Ongoing","Garden-Fresh Foods, Inc.","Milwaukee","WI","US","Voluntary: Firm Initiated","Press Release","IL, IN, MI, MN, MO, OH, PA, WI.","F-0972-2014","Class I","Garden-Fresh, Italian Market Salad Kit, 1/5.25 lb., 0 11596 62208 8, 11/25/2013; ","0 11596 62208 8, 11/25/2013; ","."," 919,616.31 total pounds, for all products","Garden-Fresh Foods is recalling various cut vegetables, ready-to-eat salads, slaw, spread and dip products sold under various brands and code dates manufactured prior to November 06, 2013 because they may be contaminated with Listeria monocytogenes.",11/7/2013,"11/07/2013",12/26/2013,"12/26/2013"
"Food",66819,"Ongoing","Garden-Fresh Foods, Inc.","Milwaukee","WI","US","Voluntary: Firm Initiated","Press Release","IL, IN, MI, MN, MO, OH, PA, WI.","F-1021-2014","Class I","Garden-Fresh, Red Onions Diced 1/4'', 1/5 lb. 0 11596 50352 3, 11/1/2013 Garden-Fresh, Red Onions Sliced 1/4'', 1/5 lb. 0 11596 50369 1, 10/28/2013 - 11/1/2103 Garden-Fresh, Red Onions Sliced 1/8'', 2/5 lb. 0 11596 50374 5, 10/29/213 - 10/31/2013 Garden-Fresh, Red Onions Sliced 3/16'' ,1/5 lb. 0 11596 50367 7, 10/28/213 ","0 11596 50352 3 11/1/2013; 0 11596 50369 1 10/28/2013 - 11/1/2103; 0 11596 50374 5 10/29/213 - 10/31/2013; 0 11596 50367 7 10/28/213; ","."," 919,616.31 total pounds, for all products","Garden-Fresh Foods is recalling various cut vegetables, ready-to-eat salads, slaw, spread and dip products sold under various brands and code dates manufactured prior to November 06, 2013 because they may be contaminated with Listeria monocytogenes.",11/7/2013,"11/07/2013",12/26/2013,"12/26/2013"
"Food",66819,"Ongoing","Garden-Fresh Foods, Inc.","Milwaukee","WI","US","Voluntary: Firm Initiated","Press Release","IL, IN, MI, MN, MO, OH, PA, WI.","F-0864-2014","Class I","Grandpa's, Baked Beans, 2/5 lb., 0 11596 55180 7, 11/26/2013 - 12/9/2013 ","0 11596 06156 6 , 0 00 11596 06156 6, 11/22/2013 - 11/26/2013; 0 11596 55180 7, 11/26/2013 - 12/9/2013 ","."," 919,616.31 total pounds, for all products","Garden-Fresh Foods is recalling various cut vegetables, ready-to-eat salads, slaw, spread and dip products sold under various brands and code dates manufactured prior to November 06, 2013 because they may be contaminated with Listeria monocytogenes.",11/7/2013,"11/07/2013",12/26/2013,"12/26/2013"
"Food",66819,"Ongoing","Garden-Fresh Foods, Inc.","Milwaukee","WI","US","Voluntary: Firm Initiated","Press Release","IL, IN, MI, MN, MO, OH, PA, WI.","F-0975-2014","Class I","Grandpa's, Krab Dip, 1/5 lb., 0 11596 55909 4, /26/2013 - 12/5/2013 ","0 11596 55909 4 11/26/2013 - 12/5/2013 ","."," 919,616.31 total pounds, for all products","Garden-Fresh Foods is recalling various cut vegetables, ready-to-eat salads, slaw, spread and dip products sold under various brands and code dates manufactured prior to November 06, 2013 because they may be contaminated with Listeria monocytogenes.",11/7/2013,"11/07/2013",12/26/2013,"12/26/2013"
"Food",66819,"Ongoing","Garden-Fresh Foods, Inc.","Milwaukee","WI","US","Voluntary: Firm Initiated","Press Release","IL, IN, MI, MN, MO, OH, PA, WI.","F-0967-2014","Class I","Dairy Fresh, Homemade Mustard Potato Salad, 2/5 lb., 0 70163 56700 9, 12/10/2013; ","0 70163 56700 9, 12/10/2013; ","."," 919,616.31 total pounds, for all products","Garden-Fresh Foods is recalling various cut vegetables, ready-to-eat salads, slaw, spread and dip products sold under various brands and code dates manufactured prior to November 06, 2013 because they may be contaminated with Listeria monocytogenes.",11/7/2013,"11/07/2013",12/26/2013,"12/26/2013"
"Food",66819,"Ongoing","Garden-Fresh Foods, Inc.","Milwaukee","WI","US","Voluntary: Firm Initiated","Press Release","IL, IN, MI, MN, MO, OH, PA, WI.","F-0854-2014","Class I","Weis, Amish Macaroni Salad, 12/16 oz., 0 41497 05844 0, 0 00 41497 05844 0, 11/25/2013 - 11/28/2013; Weis, Amish Macaroni Salad, 4/3 lb. 0 41497 05905 8, 0 00 41497 05905 8, 11/21/2013 - 12/3/2013; Weis, Amish Macaroni Salad, 2/5 lb. , 0 11596 52105 3, 11/21/2013 - 12/3/2013; ;","0 41497 05844 0, 0 00 41497 05844 0, 11/25/2013 - 11/28/2013; 0 41497 05905 8, 0 00 41497 05905 8, 11/21/2013 - 12/3/2013; 0 11596 52105 3, 11/21/2013 - 12/3/2013; ","."," 919,616.31 total pounds, for all products","Garden-Fresh Foods is recalling various cut vegetables, ready-to-eat salads, slaw, spread and dip products sold under various brands and code dates manufactured prior to November 06, 2013 because they may be contaminated with Listeria monocytogenes.",11/7/2013,"11/07/2013",12/26/2013,"12/26/2013"
"Food",66819,"Ongoing","Garden-Fresh Foods, Inc.","Milwaukee","WI","US","Voluntary: Firm Initiated","Press Release","IL, IN, MI, MN, MO, OH, PA, WI.","F-0940-2014","Class I","Our Own, Fettucine Pasta Salad, 1/5 lb., 0 11596 52150 3, 11/21/2013 - 12/6/2013 "," 0 11596 52150 3, 11/21/2013 - 12/6/2013 ","."," 919,616.31 total pounds, for all products","Garden-Fresh Foods is recalling various cut vegetables, ready-to-eat salads, slaw, spread and dip products sold under various brands and code dates manufactured prior to November 06, 2013 because they may be contaminated with Listeria monocytogenes.",11/7/2013,"11/07/2013",12/26/2013,"12/26/2013"
"Food",66819,"Ongoing","Garden-Fresh Foods, Inc.","Milwaukee","WI","US","Voluntary: Firm Initiated","Press Release","IL, IN, MI, MN, MO, OH, PA, WI.","F-0877-2014","Class I","Martin's, Broccoli Bacon Salad Kit, 5.8675 lb. , 0 11596 55357 3 , 11/9/2013 - 11/11/2013 ","0 11596 55357 3 , 11/9/2013 - 11/11/2013 ","."," 919,616.31 total pounds, for all products","Garden-Fresh Foods is recalling various cut vegetables, ready-to-eat salads, slaw, spread and dip products sold under various brands and code dates manufactured prior to November 06, 2013 because they may be contaminated with Listeria monocytogenes.",11/7/2013,"11/07/2013",12/26/2013,"12/26/2013"
"Drugs",66820,"Ongoing","Baxter Healthcare Corp.","Deerfield","IL","US","Voluntary: Firm Initiated","Letter","Nationwide","D-368-2014","Class II","10%, Travasol (Amino Acid) Injection, 2000 ml, Pharmacy Bulk Package Not for Direct Infusion, Baxter Healthcare Corporation, Clintec Nutrition Division, Deerfield IL 60015 USA. NDC: 0338-0644-06.","Lot: P302646, Exp 5/31/15",".","14,622 bags","Lack of Assurance of Sterility; Drug product leaking from container, therefore sterility cannot be assured",11/12/2013,"11/12/2013",12/26/2013,"12/26/2013"
"Food",66821,"Ongoing","Ortho Molecular Products Inc","Stevens Point","WI","US","Voluntary: Firm Initiated","Letter","nationwide. Outside the U.S. to include China and Mexico.","F-0348-2014","Class II","Ortho Molecular Products DigestzymeV. Dietary Supplement. Gastrointestinal health. 90 (product code 128090 and 128090U) and 180 capsules (product code 128180 and 128180U).","Lot numbers beginning with: 73639, 73771, 73961, 74127, 74232, 74307, 74464, 74575, 74753, 74895, 75046, 75172",".","52,921 bottles","Ortho Molecular Products' vegetable enzyme vendor issued a recall of the raw material due to potential chloramphenicol contamination.",11/7/2013,"11/07/2013",12/4/2013,"12/04/2013"
"Drugs",66822,"Ongoing","Greenstone Llc","Peapack","NJ","US","Voluntary: Firm Initiated","Letter","Nationwide and Puerto Rico","D-011-2014","Class II","Spironolactone tablets, USP 50 mg, Rx only, 100 count bottle, Distributed By: Greenstone LLC, Peapack, NJ 07977, NDC: 59762-5012-1","Lot #: V121211, Exp 03/31/2017",,"4848 bottles","Marketed without an Approved NDA/ANDA: This recall is being initiated because of changes to the dissolution profile in distributed lots resulting from a manufacturing site change. There is currently no approved application supporting the alternate manufacturing site.",9/4/2013,"09/04/2013",11/27/2013,"11/27/2013"
"Drugs",66822,"Ongoing","Greenstone Llc","Peapack","NJ","US","Voluntary: Firm Initiated","Letter","Nationwide and Puerto Rico","D-010-2014","Class II","Spironolactone tablets, USP 25 mg, Rx only, 500 count bottle, Distributed By: Greenstone LLC, Peapack, NJ 07977, NDC: 59762-5011-2.","Lot #: V121207, V121208, Exp 03/31/2017",,"2796 bottles","Marketed without an Approved NDA/ANDA: This recall is being initiated because of changes to the dissolution profile in distributed lots resulting from a manufacturing site change. There is currently no approved application supporting the alternate manufacturing site.",9/4/2013,"09/04/2013",11/27/2013,"11/27/2013"
"Devices",66823,"Ongoing","Karl Storz Endoscopy America Inc","Southbridge","MA","US","Voluntary: Firm Initiated","Letter","Nationwide Distribution including states of: TX, PA, and NY.","Z-0465-2014","Class II","Axillent Debakey Grasping Forceps, Part No. 33821DYD In general the surgeons use 33821DYD Debakey forceps to grasp tissue.","Lot Code YX",,"7 units","KARL STORZ is recalling the Axillent Debakey Grasping Forceps because the 33821WTD Wavy grasper was mislabeled as 33821DYD Axillent Debakey Grasping Forceps.",11/6/2013,"11/06/2013",12/18/2013,"12/18/2013"
"Food",66824,"Ongoing","Houston Nutraceuticals, Inc","Siloam Springs","AR","US","Voluntary: Firm Initiated","E-Mail","The product was not distributed domestically. The product was distributed Internationally to Brazil","F-0381-2014","Class II","TriEnza bulk powder distributed in a 5 kilogram polyethylene bag.","Lot # 83381000",".","5 kg","The firm is recalling a dietary supplement containing a raw material which may contain >0.3 ppb of chloramphenicol.",11/8/2013,"11/08/2013",12/4/2013,"12/04/2013"
"Devices",66826,"Ongoing","Beckman Coulter Inc.","Brea","CA","US","Voluntary: Firm Initiated","Letter","Worldwide Distribtion - USA Nationwide including the countries of Algeria, Andorra, Angola, Australia, Austria, Bahrain, Bangladesh, Belgium, Bermuda, Bosnia and Herzegovina, Bulgaria, China, Colombia, Croatia, Czech Republic, Ecuador, Egypt, France, Germany, Greece, Guatemala, Honduras, Hong Kong, Hungary, India, Indonesia, Ireland, Israel, Italy, Japan, Jordan, Korea, Republic of, Kuwait, Latvia, Lebanon, Libyan Arab Jamahiriya, Lithuania, Macao, Malaysia, Mayotte, Mexico, Morocco, Myanmar, Netherlands, New Zealand, Pakistan, Panama, Philippines, Poland, Portugal, Puerto Rico, Qatar, Romania, Russian Federation, Saudi Arabia, Serbia, Singapore, Slovakia, Slovenia, South Africa, Spain, Sweden, Switzerland, Taiwan, Thailand, Trinidad and Tobago, Tunisia, Turkey, United Arab Emirates, United Kingdom, Uruguay, Venezuela, Viet Nam, Virgin Islands, U.S., and Zimbabwe.","Z-0470-2014","Class II","Coulter LH 750 Hematology Analyzer, Part No. 6605632, A85570 Product Usage: The Coulter LH 750 Hematology Analyzer is a quantitative, automated hematology analyzer and leukocyte differential counter For In Vitro Diagnostic Use in clinical laboratories. The Coulter LH 750 Hematology Analyzer provides automated Reticulocyte analysis and enumeration of nucleated red blood cells (NRBCs) as well as an automated method for enumeration of RBCs and WBCs in body fluids ","n/a",,"4155 units total (1676 units in US)","Beckman Coulter is recalling the LH 750 and LH 780 Hematology Systems because the optical degradation may potentially cause a delay in reporting results for nucleated red blood cells (nRBC), white blood cell differential and/or reticulocytes.",11/8/2013,"11/08/2013",12/18/2013,"12/18/2013"
"Devices",66826,"Ongoing","Beckman Coulter Inc.","Brea","CA","US","Voluntary: Firm Initiated","Letter","Worldwide Distribtion - USA Nationwide including the countries of Algeria, Andorra, Angola, Australia, Austria, Bahrain, Bangladesh, Belgium, Bermuda, Bosnia and Herzegovina, Bulgaria, China, Colombia, Croatia, Czech Republic, Ecuador, Egypt, France, Germany, Greece, Guatemala, Honduras, Hong Kong, Hungary, India, Indonesia, Ireland, Israel, Italy, Japan, Jordan, Korea, Republic of, Kuwait, Latvia, Lebanon, Libyan Arab Jamahiriya, Lithuania, Macao, Malaysia, Mayotte, Mexico, Morocco, Myanmar, Netherlands, New Zealand, Pakistan, Panama, Philippines, Poland, Portugal, Puerto Rico, Qatar, Romania, Russian Federation, Saudi Arabia, Serbia, Singapore, Slovakia, Slovenia, South Africa, Spain, Sweden, Switzerland, Taiwan, Thailand, Trinidad and Tobago, Tunisia, Turkey, United Arab Emirates, United Kingdom, Uruguay, Venezuela, Viet Nam, Virgin Islands, U.S., and Zimbabwe.","Z-0471-2014","Class II","Coulter LH 780 Hematology Analyzer, Part No. 723585, A90728 Product Usage: Coulter LH 780 Hematology Analyzer is a is a quantitative, automated hematology analyzer and leukocyte differential counter For In Vitro Diagnostic Use in clinical laboratories. The Coulter LH 780 Hematology Analyzer also provides automated Reticulocyte analysis and enumeration of nucleated red blood cells (NRBCs) as well as an automated method for enumeration of RBCs and WBCs in body fluids. ","n/a",,"1961 units total (610 units in US)","Beckman Coulter is recalling the LH 750 and LH 780 Hematology Systems because the optical degradation may potentially cause a delay in reporting results for nucleated red blood cells (nRBC), white blood cell differential and/or reticulocytes.",11/8/2013,"11/08/2013",12/18/2013,"12/18/2013"
"Biologics",66827,"Ongoing","One Lambda Inc","Canoga Park","CA","US","Voluntary: Firm Initiated","E-Mail","Nationwide and Worldwide","B-0147-14","Class III","Micro SSP'' DNA Typing Trays, Micro SSP High Resolution HLA Class II Tray, Catalog Identification: SSP2H. 510(K) Number: BK960062","Micro SSP High Resolution HLA Class II Tray; Catalog Identification: SSP2H Article Number: SSP_DNAT_PI Rev 18 Lot number: 005, batches 003-034",,"1","HLA typing assay, in certain instances associated with incorrect typing results, was distributed. ",11/7/2013,"11/07/2013",12/18/2013,"12/18/2013"
"Devices",66828,"Ongoing","Boston Scientific Corporation","Marlborough","MA","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution-USA (nationwide) including Puerto Rico and the countries of Australia, Ireland, Denmark, Italy, France, Canada, Great Britain, Switzerland, South Africa, Germany, and the Netherlands.","Z-0440-2014","Class II","Navigator HD l3F/15F x 28 cm Ureteral Access Sheath Set Product No M0062502270, RDF Catalog No 250-227, Sterile. Indicated for use in endoscopic procedures to facilitate the passage of endoscopes, urological instruments and for the injection of fluids into the urinary tract."," UPN M0062502270, Catalog 250-227, Lot 15708431, 15708432, 15708433, 15812875, 15836355, 15855545, 15876213 , 15896950, 15935564, 16028474, 16044445, and 16046280",".","274","The 13F/15F Navigator HD Ureteral Access SheathSet are being recalled after receipt of 5 reports where the tip of the dilator has separated fro the body of the dilator. ",11/5/2013,"11/05/2013",12/11/2013,"12/11/2013"
"Devices",66828,"Ongoing","Boston Scientific Corporation","Marlborough","MA","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution-USA (nationwide) including Puerto Rico and the countries of Australia, Ireland, Denmark, Italy, France, Canada, Great Britain, Switzerland, South Africa, Germany, and the Netherlands.","Z-0442-2014","Class II","Navigator HD l3F/15F x 36cm Ureteral Access Sheath Set Product No M0062502280, RDF Catalog No 250-228, Sterile. Indicated for use in endoscopic procedures to facilitate the passage of endoscopes, urological instruments and for the injection of fluids into the urinary tract.","UPN M0062502290, Catalog 250-229, 15579545, 15579546, 15615465, 15630771, 15630772, 15688533, 15688534, 15813601, 15823202, 15880464, 15927981, 16159896, 16175942, 16196763, 16373048, ",".","449","The 13F/15F Navigator HD Ureteral Access SheathSet are being recalled after receipt of 5 reports where the tip of the dilator has separated fro the body of the dilator. ",11/5/2013,"11/05/2013",12/11/2013,"12/11/2013"
"Devices",66828,"Ongoing","Boston Scientific Corporation","Marlborough","MA","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution-USA (nationwide) including Puerto Rico and the countries of Australia, Ireland, Denmark, Italy, France, Canada, Great Britain, Switzerland, South Africa, Germany, and the Netherlands.","Z-0441-2014","Class II","Navigator HD l3F/15F x 36cm Ureteral Access Sheath Set Product No M0062502280, RDF Catalog No 250-228, Sterile. Indicated for use in endoscopic procedures to facilitate the passage of endoscopes, urological instruments and for the injection of fluids into the urinary tract.","UPN M0062502280, Catalog 250-228, Lot 15753725,15819257,15840833,1587719, 15918445,15931128, 16008343,16015286, 16065866,16141201, 16295107,16319657 ",".","939","The 13F/15F Navigator HD Ureteral Access SheathSet are being recalled after receipt of 5 reports where the tip of the dilator has separated fro the body of the dilator. ",11/5/2013,"11/05/2013",12/11/2013,"12/11/2013"
"Food",66829,"Ongoing","Allergy Research Group","Alameda","CA","US","Voluntary: Firm Initiated","Letter","IL, FL. GA, NV, NY, CA, NH, AZ and Switzerland and New Zealand","F-703-2014","Class II","Allergy Research Group Sugar Balance Formula, dietary Supplement, Hypoallergenic, 90 vegetarian capsules. Formulated exclusively for: Allergy Research Group; Alameda, CA 94502.","Product number 75660, Lot number 0613057; Expiration: August 2015.",".","182 bottles of 90 casules each","Firm was notified by their contract manufacturer that a voluntary recall had been issued by the raw material supplier because certain cellulase enzymes have been found to be contaminated with Chloramphenicol.",11/11/2013,"11/11/2013",12/11/2013,"12/11/2013"
"Devices",66830,"Ongoing","Centurion Medical Products Corporation","Howell","MI","US","Voluntary: Firm Initiated","E-Mail","US Distribution including the states of GA, LA and NY.","Z-0464-2014","Class II","Centurion Sterile # 84 Rubber Bands Reorder EB84, Caution: This product contains natural rubber latex which may cause allergic reactions. LATEX FREE , CAUTION: FEDERAL lAW (USA) RESTRICTS THIS DEVICE TO SALE BY OR ON THE ORDER OF A PHYSICIAN Single Use Only bands items together and podiatry office uses bands as tourniquet on toe during in grown toenail procedure","EB84, Lot 2013041801 Expriation 2018/03",,"500 lots ","Package labeling indicates both ''latex free'' and ''contains natural rubber latex'' . The rubber bands do contain natural rubber latex. This could cause a significant risk to users with latex allergies.",10/28/2013,"10/28/2013",12/18/2013,"12/18/2013"
"Food",66831,"Ongoing","Dawn's Foods, Inc.","Portage","WI","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","WI only","F-0721-2014","Class I","Dawn's Vidalia Onion Dip, Net Wt. 5 lbs. (2.27 kg)","Use By: 11/27/13 - 1/15/14",,"189 cases (2-5 lb containers per case)","Dawn's Foods is recalling Vandellia Onion Dip due to undeclared egg. ",11/11/2013,"11/11/2013",12/18/2013,"12/18/2013"
"Devices",66834,"Ongoing","Accumetrics Inc","San Diego","CA","US","Voluntary: Firm Initiated","Letter","Nationwide Distribution including NY, PA, DC, CT, IN, NJ, AR, TX, AZ,and NM.","Z-0482-2014","Class II","VerifyNow IIb/IIIa Test, 10-Test Kit, Catalog No. 85310, 10 tests/box; 690 total tests. The VerifyNow IIb/IlIa Test is a semi-quantitative, whole blood platelet function test used to measure glycoprotein (GP) lIb/IlIa receptor blockade in patients treated with abciximab or eptifibatide. VerifyNow lIb/IlIa Test results should be interpreted in conjunction with other clinical and laboratory data available to the clinician. The VerifyNow System is a turbidimetric based optical detection system which measures platelet-induced aggregation. The system consists of an instrument, a disposable test device and quality control materials. The VerifyNow lIb/IlIa Test is a semi-quantitative, whole blood platelet function test used to measure glycoprotein (GP) lIb/IlIa receptor blockade in patients treated with abciximab or eptifibatide.","Lot No. WC0181H, WC0181J, WC0181K",,"69 units","Accumetrics is recalling the VerifyNow IIb/IIIa 10-Test because it contains incorrect information for the amount of time in which to perform the test following collection of the patient sample. The correct instruction is to perform the test within 15 minutes of collecting the patient sample.",11/14/2013,"11/14/2013",12/18/2013,"12/18/2013"
"Devices",66836,"Ongoing","Lanx, Inc.","Broomfield","CO","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Nationwide Distribution including AZ, PA, WI, NY, TX, PR, and TN.","Z-0400-2014","Class II","LANX Timberline MPF Lateral Modular Plate Fixation System Straight Split Tip Driver - Short (''Driver''). Model Number 8630-0107. The Timberline MPF device is an intervertebral body fusion device consisting of a PEEK intervertebral spacer, titanium plate, and screws. The PEEK spacer has a generally rounded shape with various heights and footprints and has a hollowed out central area to accommodate autogenous bone graft. The upper and lower surfaces have a series of transverse grooves formed to improve stability and fixation once the device is inserted. The titanium plate has holes for receiving bone screws and a central hole for receiving a cover plate to prevent screw back-out. The Timberline MPF system is available in a variety of sizes and configurations to approximate anatomical variation in different vertebral levels and/or patient anatomy. The Timberline MPF system is provided nonsterile. The Driver is used with the Timberline MPF system to drive titanium screws through the plate and into the vertebrae thus locking plate to the vertebrae.","Lot No: TU00090, TU00157 and TU00242",".","25 units","Lanx, Inc. is recalling various lots of Timberline MPF Straight Split Tip Driver - Short (''Driver'') because the width of the most distal end from the Driver handle (the tip of the hex portion of the Driver) is oversized.",11/4/2013,"11/04/2013",12/4/2013,"12/04/2013"
"Devices",66842,"Ongoing","Qualigen Inc","Carlsbad","CA","US","Voluntary: Firm Initiated","Telephone","US Distribution to states of: AL, CA, KS, KY, IN, MA, NC, NY, NV, OK, SC, TN, TX, UT, VA, and WA.","Z-0548-2014","Class II","FastPack Testosterone Immunoassay Chemilunescence assay for the determination of Testosterone Testosterone The FastPack Testo Immunoassay is a paramagnetic particle immunoassay for the in vitro quantitative determination of total testosterone in human serum and plasma. It is intended strictly for in-vitro diagnostic use as an aid in the diagnosis and management of conditions involving excess or deficiency of this androgen. The FastPack Testo Immunoassay is designed for use with the FastPack System.","Testosterone. Catalog Number 25000041. Lot Number 1310019-3P Exp Date: 9/22/2014",".","18","Qualigen initiated this recall because the FastPack kit may cause lower than expected results due to a manufacturing defect.",11/8/2013,"11/08/2013",12/26/2013,"12/26/2013"
"Devices",66842,"Ongoing","Qualigen Inc","Carlsbad","CA","US","Voluntary: Firm Initiated","Telephone","US Distribution to states of: AL, CA, KS, KY, IN, MA, NC, NY, NV, OK, SC, TN, TX, UT, VA, and WA.","Z-0550-2014","Class II","FastPack Free T4 Immunoassay FastPack Vitamin D Immunoassay Chemilunescence assay for the determination of Vitamin D Vitamin D The FastPack Vitamin D Immunoassay is intended for the quantitative determination of FastPack Total PSA Immunoassay Chemilunescence assay for the determination of Total PSA FastPack Total PSA Immunoassay is a paramagnetic particle immunoassay for the in vitro quantitative determination of prostate-specific antigen (PSA) in human serum and plasma as an aid in the management of patients with prostate cancer.","Testosterone. Catalog Number 25000059. Lot Number 1309062-2P.Exp Date: 7/9/2014",".","6","Qualigen initiated this recall because the FastPack kit may cause lower than expected results due to a manufacturing defect.",11/8/2013,"11/08/2013",12/26/2013,"12/26/2013"
"Devices",66842,"Ongoing","Qualigen Inc","Carlsbad","CA","US","Voluntary: Firm Initiated","Telephone","US Distribution to states of: AL, CA, KS, KY, IN, MA, NC, NY, NV, OK, SC, TN, TX, UT, VA, and WA.","Z-0549-2014","Class II","FastPack Free T4 Immunoassay Chemilunescence assay for the determination of Free T4 Free T4 The FastPack free T4 Immunoassay is a paramagnetic particle immunoassay for the in vitro quantitative determination of FT4 in human serum. The FastPack free T4 Immunoassay is designed for use with the FastPack System.","Testosterone. Catalog Number 25000043. Lot Number 1310028-2P.Exp Date: 4/10/2014",".","17","Qualigen initiated this recall because the FastPack kit may cause lower than expected results due to a manufacturing defect.",11/8/2013,"11/08/2013",12/26/2013,"12/26/2013"
"Devices",66842,"Ongoing","Qualigen Inc","Carlsbad","CA","US","Voluntary: Firm Initiated","Telephone","US Distribution to states of: AL, CA, KS, KY, IN, MA, NC, NY, NV, OK, SC, TN, TX, UT, VA, and WA.","Z-0547-2014","Class II","FastPack Total PSA Immunoassay Chemilunescence assay for the determination of Total PSA. Total PSA FastPack Total PSA Immunoassay is a paramagnetic particle immunoassay for the in vitro quantitative determination of prostate-specific antigen (PSA) in human serum and plasma as an aid in the management of patients with prostate cancer. The FastPack Total PSA Immunoassay is designed for use with the FastPack System.","Total PSA: Catalog Number 25000040. Lot Number 1309038-10P Exp Date 6/26/2013.",".","182","Qualigen initiated this recall because the FastPack kit may cause lower than expected results due to a manufacturing defect.",11/8/2013,"11/08/2013",12/26/2013,"12/26/2013"
"Devices",66844,"Ongoing","CooperVision Inc.","W Henrietta","NY","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution - USA (nationwide) and the countries of Aruba, Canada, Colombia and Trinidad.","Z-0543-2014","Class II","ClearSight(TM) Toric 1 day (ocufilcon D), 30 daily disposable contact lenses for astigmatism, STERILE, Rx only --- CooperVision Hamble, SO31 4RF, UK - Scottsville, NY 14546 USA - Juana Diaz, PR 00795 USA daily use disposable contact lenses for astigmatism","Lot 446350083516, potential incorrect expiry date 6/2019; Lot 446450110928, potential incorrect expiry date 2/2019; Lot 446450173709, potential incorrect expiry date 4/2018; Lot 446450191100, potential incorrect expiry date 5/2019; Lot 446550083005, potential incorrect expiry date 5/2019; Lot 446550084607, potential incorrect expiry date 2/2018; Lot 446650162408, potential incorrect expiry date 2/2018; Lot 446650177200, potential incorrect expiry date 2/2018; Lot 446650178110, potential incorrect expiry date 6/2017; Lot 446650179207, potential incorrect expiry date 6/2018; Lot 446750082713, potential incorrect expiry date 7/2019; Lot 446850029326, potential incorrect expiry date 4/2016; Lot 446850032905, potential incorrect expiry date 4/2016; Lot 446850129305, potential incorrect expiry date 1/2019; Lot 446850132713, potential incorrect expiry date 3/2019; Lot 446850133506, potential incorrect expiry date 6/2018; Lot 447050177419, potential incorrect expiry date 2/2018; Lot 447050181906, potential incorrect expiry date 1/2017; Lot 447050206016, potential incorrect expiry date 11/2019.",".","45 cartons","Lots were labeled with incorrect expiration dates on secondary package (carton). The primary package (blister) is marked with the correct expiration date. ",11/20/2013,"11/20/2013",12/26/2013,"12/26/2013"
"Devices",66844,"Ongoing","CooperVision Inc.","W Henrietta","NY","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution - USA (nationwide) and the countries of Aruba, Canada, Colombia and Trinidad.","Z-0542-2014","Class II","Pro clear(R) 1 day Sphere (o mafilcon A), 90 daily disposable contact lenses, STERILE, Rx ONLY --- Coopervision Shamble, SO 31 4 RF, UK - Scottsville, NY 14546 USA - Juana Diaz, PR 00795 USA daily use disposable contact lenses ","Lot 361950571720, potential incorrect expiry date 1/2018; Lot 361950575934, potential incorrect expiry date 9/2017; Lot 361950589008, potential incorrect expiry date 2/2018; Lot 361950590915, potential incorrect expiry date 8/2018; Lot 361950597210, potential incorrect expiry date 7/2017; Lot 361950599011, potential incorrect expiry date 8/2018; Lot 361950599816, potential incorrect expiry date 9/2017; Lot 361950606714, potential incorrect expiry date 12/2017; Lot 361950608721, potential incorrect expiry date 6/2018; Lot 361950613813, potential incorrect expiry date 1/2018; Lot 361950632507, potential incorrect expiry date 3/2018; Lot 361950638202, potential incorrect expiry date 2/2017; Lot 361950644719, potential incorrect expiry date 10/2018; Lot 361950646326, potential incorrect expiry date 10/2018; Lot 361950647128, potential incorrect expiry date 10/2018; Lot 361950676608, potential incorrect expiry date 12/2018; Lot 361950682615, potential incorrect expiry date 10/2017; Lot 361950684220, potential incorrect expiry date 10/2019; Lot 361950691505, potential incorrect expiry date 1/2017; Lot 361950692806, potential incorrect expiry date 7/2018; Lot 361950706108, potential incorrect expiry date 12/2018; Lot 361950706308, potential incorrect expiry date 1/2015; Lot 361950711903, potential incorrect expiry date 7/2018; Lot 361950712707, potential incorrect expiry date 2/2017; Lot 361950742714, potential incorrect expiry date 1/2017; Lot 361950744516, potential incorrect expiry date 10/2017; Lot 361950767118, potential incorrect expiry date 4/2018; Lot 361950778620, potential incorrect expiry date 1/2018; Lot 361950789608, potential incorrect expiry date 4/2018; Lot 361950800811, potential incorrect expiry date 3/2017; Lot 361950826215, potential incorrect expiry date 3/2018; Lot 361950829333, potential incorrect expiry date 9/2017; Lot 361950839008, potential incorrect expiry date 4/2017; Lot 361950845916, potential incorrect expiry date 3/2018; Lot 361950859017, potenti",".","153 cartons","Lots were labeled with incorrect expiration dates on secondary package (carton). The primary package (blister) is marked with the correct expiration date. ",11/20/2013,"11/20/2013",12/26/2013,"12/26/2013"
"Biologics",66849,"Terminated","Jubilant HollisterStier, LLC","Spokane","WA","US","Voluntary: Firm Initiated","Letter","Multiple U.S. States","B-0133-14","Class III","Mixed Vespid Venom Protein","A1300105; A1300104; ",,"2 kits","Misbranded venomil maintenance kits were distributed.",10/16/2013,"10/16/2013",12/18/2013,"12/18/2013"
"Devices",66859,"Ongoing","Kimberly-Clark Corporation","Roswell","GA","US","Voluntary: Firm Initiated","Letter","U.S. Nationwide Distribution","Z-0518-2014","Class II","Kimberly-Clark Single Shot Epidural Pain Management Trays containing the BD LOR Syringe (BD Code 405198) Product Usage: The device is designed to provide regional anesthesia. The device may contain syringes, needles and drugs ","Lot numbers: 181024, 181129 181217, 181221, 181231, 182022, 182058, 182101, 182108, 182131, 182222, 182223, 182263, 182265, 182289, 182293, 182301, 182315, 181A074, 181A94, 181A154, 181A177, 181A286, 181A289, 181A369, 182A002, 182A005, 182A012, 182A055, 182A056, 182A057, 182A064, 182A074, 182A075/182A78, 182A085, 182090, 182A142, 182AA144, 182A151, 182A155, 182A178, 182A194, 182A196, 182A198, 182A202, 182A204, 182A212, 182A216 and 189A001 (syringe).",".","389,300 units","Kimberly-Clark Single Shot Epidural Pain Management Trays contain the BD 7 mL Epilor plastic Luer-Lok LOR Syringes under recall by Becton Dickinson (BD) because the product may stall or stick when traveling within the barrel of the syringe.",10/24/2013,"10/24/2013",12/26/2013,"12/26/2013"
"Food",66860,"Ongoing","Mrm","Oceanside","CA","US","Voluntary: Firm Initiated","Letter","Nationwide in US","F-0350-2014","Class II","Gluten Free 60 vcaps, sku#609492310194. 12 units per shipping carton/case.","Lot Numbers: 120950, 130211, 130411, and 130763.",".","4,836 units","Metabolic Response Modifier (MRM) is recalling Gluten Free 60 vcaps because it may contain trace amounts of the antibiotic, chloramphenicol.",11/13/2013,"11/13/2013",12/4/2013,"12/04/2013"
"Devices",66862,"Ongoing","Karl Storz Endoscopy America Inc","Southbridge","MA","US","Voluntary: Firm Initiated","Letter","Nationwide Distribution.","Z-0526-2014","Class II","Intubation Flexible Fiberscope, Models: 11301AA1, 11301BN1, 11302BD1, 11302BD2, 11304BC1, 11340BC1, 11301BND1, 11302BDD1, and 11302BDD2. '' Transoral intubation '' Transnasal intubation '' Evaluation of placement of endotracheal and double lumen endotracheal tubes '' Provide visual access to the larynx and tracheobronchial tree. ","C1140, C1140E, C1160, C1160E, QKC1750, QKC1750E, QKC1694, QKC1694E",".","1516 units","KARL STORZ Endoscopy America, Inc. is recalling the Flexible Broncho Fiberscope or a Flexible Intubation Fiberscope with a suction port because the material used in the suction channel portion was thermoplastic polyurethane (TPU), which is not listed in STERRAD systems claims for interior endoscope lumens.",11/13/2013,"11/13/2013",12/26/2013,"12/26/2013"
"Devices",66862,"Ongoing","Karl Storz Endoscopy America Inc","Southbridge","MA","US","Voluntary: Firm Initiated","Letter","Nationwide Distribution.","Z-0527-2014","Class II","Broncho Flexible Fiberscope, models: 11001BN1, 11002BD1, 11004BC1, and 11009BC1. '' Examination and treatment of the tracheobronchial tree Contraindications for Bronchoscopy '' Uncontrolled angina, uncontrolled heart failure, or serious uncontrolled ventricular arrhythmias '' Uncontrolled hypertension '' Bleeding disorder or use of anticoagulants. ","C1140, C1140E, C1160, C1160E, QKC1750, QKC1750E, QKC1694, QKC1694E",".","141 units","KARL STORZ Endoscopy America, Inc. is recalling the Flexible Broncho Fiberscope or a Flexible Intubation Fiberscope with a suction port because the material used in the suction channel portion was thermoplastic polyurethane (TPU), which is not listed in STERRAD systems claims for interior endoscope lumens.",11/13/2013,"11/13/2013",12/26/2013,"12/26/2013"
"Food",66863,"Ongoing","4Life Research, LLC","Sandy","UT","US","Voluntary: Firm Initiated","Letter","Worldwide and in all of the US states. No military/govt/VA consignees.","F-0349-2014","Class II","Digestive Enzymes, Digestion, 4Life, Dietary Supplement, 90 Capsules, A Product of 4Life Manufactured by BioMedical Research Laboratories, LLC, Sandy, UT, Item #23017.","Lot No: 12020023, 12060043, 12080147, 12090208, 13060177, and 13080062.",".","55,836 units","4Life Research, LLC is voluntarily recalling various lots of Digestive Enzymes product due to the presence of trace amounts of the antibiotic, chloramphenicol.",11/14/2013,"11/14/2013",12/4/2013,"12/04/2013"
"Devices",66864,"Ongoing","DePuy Orthopaedics, Inc.","Warsaw","IN","US","Voluntary: Firm Initiated",,"Worldwide Distribution - USA (nationwide) including AR,AZ,CA,CO,FL,GA,HI,IA,IL,IN,KY,LA,MA,MD,ME,MI,MN,MT,NC,NV,NY,OH,PA, TX,VA,WA,WI and Internationally to: AUSTRALIA AUSTRIA BELGIUM BRAZIL CANADA CZECH REPUBLIC DENMARK EGYPT FRANCE GERMANY GREECE HOLLAND HUNGARY INDIA IRELAND ISRAEL ITALY JAPAN KOREA MALAYSIA NEW ZEALAND NORWAY P R CHINA PAKISTAN PANAMA POLAND PORTUGAL PUERTO RICO RUSSIA SAUDI ARABIA SINGAPORE SLOVENIA SOUTH AFRICA SPAIN SWEDEN SWITZERLAND TURKEY UAE UK","Z-0417-2014","Class II","SIGMA LCS HIGH PERFORMANCE'' MBT KEEL PUNCH NONCEMENTED Size 4-7 HP M.B.T. Keel Punch Knee Instrument is used to prepare the proximal tibial canal geometry to accept the final or definitive tibial tray used during total knee arthroplasty. ","Item #950502015",".","29,235 units in total / 2008 through November 2013","DePuy Orthopaedics, Inc. is issuing a voluntary device correction of the HP M.B.T. Keel Punch Knee Instrument because of the potential for tabs on the connection end to fracture and be left in the patient. ",11/18/2013,"11/18/2013",12/4/2013,"12/04/2013"
"Devices",66864,"Ongoing","DePuy Orthopaedics, Inc.","Warsaw","IN","US","Voluntary: Firm Initiated",,"Worldwide Distribution - USA (nationwide) including AR,AZ,CA,CO,FL,GA,HI,IA,IL,IN,KY,LA,MA,MD,ME,MI,MN,MT,NC,NV,NY,OH,PA, TX,VA,WA,WI and Internationally to: AUSTRALIA AUSTRIA BELGIUM BRAZIL CANADA CZECH REPUBLIC DENMARK EGYPT FRANCE GERMANY GREECE HOLLAND HUNGARY INDIA IRELAND ISRAEL ITALY JAPAN KOREA MALAYSIA NEW ZEALAND NORWAY P R CHINA PAKISTAN PANAMA POLAND PORTUGAL PUERTO RICO RUSSIA SAUDI ARABIA SINGAPORE SLOVENIA SOUTH AFRICA SPAIN SWEDEN SWITZERLAND TURKEY UAE UK","Z-0414-2014","Class II","SIGMA LCS HIGH PERFORMANCE'' MBT KEEL PUNCH CEMENTED Size 4-7 HP M.B.T. Keel Punch Knee Instrument is used to prepare the proximal tibial canal geometry to accept the final or definitive tibial tray used during total knee arthroplasty.","Item #950502012",".","29,235 units in total / 2008 through November 2013","DePuy Orthopaedics, Inc. is issuing a voluntary device correction of the HP M.B.T. Keel Punch Knee Instrument because of the potential for tabs on the connection end to fracture and be left in the patient. ",11/18/2013,"11/18/2013",12/4/2013,"12/04/2013"
"Devices",66864,"Ongoing","DePuy Orthopaedics, Inc.","Warsaw","IN","US","Voluntary: Firm Initiated",,"Worldwide Distribution - USA (nationwide) including AR,AZ,CA,CO,FL,GA,HI,IA,IL,IN,KY,LA,MA,MD,ME,MI,MN,MT,NC,NV,NY,OH,PA, TX,VA,WA,WI and Internationally to: AUSTRALIA AUSTRIA BELGIUM BRAZIL CANADA CZECH REPUBLIC DENMARK EGYPT FRANCE GERMANY GREECE HOLLAND HUNGARY INDIA IRELAND ISRAEL ITALY JAPAN KOREA MALAYSIA NEW ZEALAND NORWAY P R CHINA PAKISTAN PANAMA POLAND PORTUGAL PUERTO RICO RUSSIA SAUDI ARABIA SINGAPORE SLOVENIA SOUTH AFRICA SPAIN SWEDEN SWITZERLAND TURKEY UAE UK","Z-0415-2014","Class II","SIGMA LCS HIGH PERFORMANCE'' MBT KEEL PUNCH NONCEMENTED Size 1-1.5 HP M.B.T. Keel Punch Knee Instrument is used to prepare the proximal tibial canal geometry to accept the final or definitive tibial tray used during total knee arthroplasty. ","Item #950502013",".","29,235 units in total / 2008 through November 2013","DePuy Orthopaedics, Inc. is issuing a voluntary device correction of the HP M.B.T. Keel Punch Knee Instrument because of the potential for tabs on the connection end to fracture and be left in the patient. ",11/18/2013,"11/18/2013",12/4/2013,"12/04/2013"
"Devices",66864,"Ongoing","DePuy Orthopaedics, Inc.","Warsaw","IN","US","Voluntary: Firm Initiated",,"Worldwide Distribution - USA (nationwide) including AR,AZ,CA,CO,FL,GA,HI,IA,IL,IN,KY,LA,MA,MD,ME,MI,MN,MT,NC,NV,NY,OH,PA, TX,VA,WA,WI and Internationally to: AUSTRALIA AUSTRIA BELGIUM BRAZIL CANADA CZECH REPUBLIC DENMARK EGYPT FRANCE GERMANY GREECE HOLLAND HUNGARY INDIA IRELAND ISRAEL ITALY JAPAN KOREA MALAYSIA NEW ZEALAND NORWAY P R CHINA PAKISTAN PANAMA POLAND PORTUGAL PUERTO RICO RUSSIA SAUDI ARABIA SINGAPORE SLOVENIA SOUTH AFRICA SPAIN SWEDEN SWITZERLAND TURKEY UAE UK","Z-0418-2014","Class II","SIGMA LCS HIGH PERFORMANCE'' MBT PUNCH CEMENTED Size 1-1.5 HP M.B.T. Keel Punch Knee Instrument is used to prepare the proximal tibial canal geometry to accept the final or definitive tibial tray used during total knee arthroplasty. ","Item #950502016",".","29,235 units in total / 2008 through November 2013","DePuy Orthopaedics, Inc. is issuing a voluntary device correction of the HP M.B.T. Keel Punch Knee Instrument because of the potential for tabs on the connection end to fracture and be left in the patient. ",11/18/2013,"11/18/2013",12/4/2013,"12/04/2013"
"Devices",66864,"Ongoing","DePuy Orthopaedics, Inc.","Warsaw","IN","US","Voluntary: Firm Initiated",,"Worldwide Distribution - USA (nationwide) including AR,AZ,CA,CO,FL,GA,HI,IA,IL,IN,KY,LA,MA,MD,ME,MI,MN,MT,NC,NV,NY,OH,PA, TX,VA,WA,WI and Internationally to: AUSTRALIA AUSTRIA BELGIUM BRAZIL CANADA CZECH REPUBLIC DENMARK EGYPT FRANCE GERMANY GREECE HOLLAND HUNGARY INDIA IRELAND ISRAEL ITALY JAPAN KOREA MALAYSIA NEW ZEALAND NORWAY P R CHINA PAKISTAN PANAMA POLAND PORTUGAL PUERTO RICO RUSSIA SAUDI ARABIA SINGAPORE SLOVENIA SOUTH AFRICA SPAIN SWEDEN SWITZERLAND TURKEY UAE UK","Z-0416-2014","Class II","SIGMA LCS HIGH PERFORMANCE'' MBT KEEL PUNCH NONCEMENTED Size 2-3 HP M.B.T. Keel Punch Knee Instrument is used to prepare the proximal tibial canal geometry to accept the final or definitive tibial tray used during total knee arthroplasty. ","Item #950502014",".","29,235 units in total / 2008 through November 2013","DePuy Orthopaedics, Inc. is issuing a voluntary device correction of the HP M.B.T. Keel Punch Knee Instrument because of the potential for tabs on the connection end to fracture and be left in the patient. ",11/18/2013,"11/18/2013",12/4/2013,"12/04/2013"
"Devices",66864,"Ongoing","DePuy Orthopaedics, Inc.","Warsaw","IN","US","Voluntary: Firm Initiated",,"Worldwide Distribution - USA (nationwide) including AR,AZ,CA,CO,FL,GA,HI,IA,IL,IN,KY,LA,MA,MD,ME,MI,MN,MT,NC,NV,NY,OH,PA, TX,VA,WA,WI and Internationally to: AUSTRALIA AUSTRIA BELGIUM BRAZIL CANADA CZECH REPUBLIC DENMARK EGYPT FRANCE GERMANY GREECE HOLLAND HUNGARY INDIA IRELAND ISRAEL ITALY JAPAN KOREA MALAYSIA NEW ZEALAND NORWAY P R CHINA PAKISTAN PANAMA POLAND PORTUGAL PUERTO RICO RUSSIA SAUDI ARABIA SINGAPORE SLOVENIA SOUTH AFRICA SPAIN SWEDEN SWITZERLAND TURKEY UAE UK","Z-0423-2014","Class II","SIGMA LCS HIGH PERFORMANCE'' MBT PUNCH NONCEMENTED Size 4-7 HP M.B.T. Keel Punch Knee Instrument is used to prepare the proximal tibial canal geometry to accept the final or definitive tibial tray used during total knee arthroplasty. ","Item #950502021",".","29,235 units in total / 2008 through November 2013","DePuy Orthopaedics, Inc. is issuing a voluntary device correction of the HP M.B.T. Keel Punch Knee Instrument because of the potential for tabs on the connection end to fracture and be left in the patient. ",11/18/2013,"11/18/2013",12/4/2013,"12/04/2013"
"Devices",66864,"Ongoing","DePuy Orthopaedics, Inc.","Warsaw","IN","US","Voluntary: Firm Initiated",,"Worldwide Distribution - USA (nationwide) including AR,AZ,CA,CO,FL,GA,HI,IA,IL,IN,KY,LA,MA,MD,ME,MI,MN,MT,NC,NV,NY,OH,PA, TX,VA,WA,WI and Internationally to: AUSTRALIA AUSTRIA BELGIUM BRAZIL CANADA CZECH REPUBLIC DENMARK EGYPT FRANCE GERMANY GREECE HOLLAND HUNGARY INDIA IRELAND ISRAEL ITALY JAPAN KOREA MALAYSIA NEW ZEALAND NORWAY P R CHINA PAKISTAN PANAMA POLAND PORTUGAL PUERTO RICO RUSSIA SAUDI ARABIA SINGAPORE SLOVENIA SOUTH AFRICA SPAIN SWEDEN SWITZERLAND TURKEY UAE UK","Z-0419-2014","Class II","SIGMA LCS HIGH PERFORMANCE'' MBT PUNCH CEMENTED Size 2-3 HP M.B.T. Keel Punch Knee Instrument is used to prepare the proximal tibial canal geometry to accept the final or definitive tibial tray used during total knee arthroplasty. ","Item #950502017",".","29,235 units in total / 2008 through November 2013","DePuy Orthopaedics, Inc. is issuing a voluntary device correction of the HP M.B.T. Keel Punch Knee Instrument because of the potential for tabs on the connection end to fracture and be left in the patient. ",11/18/2013,"11/18/2013",12/4/2013,"12/04/2013"
"Devices",66864,"Ongoing","DePuy Orthopaedics, Inc.","Warsaw","IN","US","Voluntary: Firm Initiated",,"Worldwide Distribution - USA (nationwide) including AR,AZ,CA,CO,FL,GA,HI,IA,IL,IN,KY,LA,MA,MD,ME,MI,MN,MT,NC,NV,NY,OH,PA, TX,VA,WA,WI and Internationally to: AUSTRALIA AUSTRIA BELGIUM BRAZIL CANADA CZECH REPUBLIC DENMARK EGYPT FRANCE GERMANY GREECE HOLLAND HUNGARY INDIA IRELAND ISRAEL ITALY JAPAN KOREA MALAYSIA NEW ZEALAND NORWAY P R CHINA PAKISTAN PANAMA POLAND PORTUGAL PUERTO RICO RUSSIA SAUDI ARABIA SINGAPORE SLOVENIA SOUTH AFRICA SPAIN SWEDEN SWITZERLAND TURKEY UAE UK","Z-0412-2014","Class II","SIGMA LCS HIGH PERFORMANCE'' MBT KEEL PUNCH CEMENTED SIZE 1-1.5 HP M.B.T. Keel Punch Knee Instrument is used to prepare the proximal tibial canal geometry to accept the final or definitive tibial tray used during total knee arthroplasty. ","Item #950502010",".","29,235 units in total / 2008 through November 2013","DePuy Orthopaedics, Inc. is issuing a voluntary device correction of the HP M.B.T. Keel Punch Knee Instrument because of the potential for tabs on the connection end to fracture and be left in the patient. ",11/18/2013,"11/18/2013",12/4/2013,"12/04/2013"
"Devices",66864,"Ongoing","DePuy Orthopaedics, Inc.","Warsaw","IN","US","Voluntary: Firm Initiated",,"Worldwide Distribution - USA (nationwide) including AR,AZ,CA,CO,FL,GA,HI,IA,IL,IN,KY,LA,MA,MD,ME,MI,MN,MT,NC,NV,NY,OH,PA, TX,VA,WA,WI and Internationally to: AUSTRALIA AUSTRIA BELGIUM BRAZIL CANADA CZECH REPUBLIC DENMARK EGYPT FRANCE GERMANY GREECE HOLLAND HUNGARY INDIA IRELAND ISRAEL ITALY JAPAN KOREA MALAYSIA NEW ZEALAND NORWAY P R CHINA PAKISTAN PANAMA POLAND PORTUGAL PUERTO RICO RUSSIA SAUDI ARABIA SINGAPORE SLOVENIA SOUTH AFRICA SPAIN SWEDEN SWITZERLAND TURKEY UAE UK","Z-0422-2014","Class II","SIGMA LCS HIGH PERFORMANCE'' MBT PUNCH NONCEMENTED Size 2-3 HP M.B.T. Keel Punch Knee Instrument is used to prepare the proximal tibial canal geometry to accept the final or definitive tibial tray used during total knee arthroplasty. ","Item #950502020",".","29,235 units in total / 2008 through November 2013","DePuy Orthopaedics, Inc. is issuing a voluntary device correction of the HP M.B.T. Keel Punch Knee Instrument because of the potential for tabs on the connection end to fracture and be left in the patient. ",11/18/2013,"11/18/2013",12/4/2013,"12/04/2013"
"Devices",66864,"Ongoing","DePuy Orthopaedics, Inc.","Warsaw","IN","US","Voluntary: Firm Initiated",,"Worldwide Distribution - USA (nationwide) including AR,AZ,CA,CO,FL,GA,HI,IA,IL,IN,KY,LA,MA,MD,ME,MI,MN,MT,NC,NV,NY,OH,PA, TX,VA,WA,WI and Internationally to: AUSTRALIA AUSTRIA BELGIUM BRAZIL CANADA CZECH REPUBLIC DENMARK EGYPT FRANCE GERMANY GREECE HOLLAND HUNGARY INDIA IRELAND ISRAEL ITALY JAPAN KOREA MALAYSIA NEW ZEALAND NORWAY P R CHINA PAKISTAN PANAMA POLAND PORTUGAL PUERTO RICO RUSSIA SAUDI ARABIA SINGAPORE SLOVENIA SOUTH AFRICA SPAIN SWEDEN SWITZERLAND TURKEY UAE UK","Z-0421-2014","Class II","SIGMA LCS HIGH PERFORMANCE'' MBT PUNCH NONCEMENTED Size 1-1.5 HP M.B.T. Keel Punch Knee Instrument is used to prepare the proximal tibial canal geometry to accept the final or definitive tibial tray used during total knee arthroplasty. ","Item #950502019",".","29,235 units in total / 2008 through November 2013","DePuy Orthopaedics, Inc. is issuing a voluntary device correction of the HP M.B.T. Keel Punch Knee Instrument because of the potential for tabs on the connection end to fracture and be left in the patient. ",11/18/2013,"11/18/2013",12/4/2013,"12/04/2013"
"Devices",66864,"Ongoing","DePuy Orthopaedics, Inc.","Warsaw","IN","US","Voluntary: Firm Initiated",,"Worldwide Distribution - USA (nationwide) including AR,AZ,CA,CO,FL,GA,HI,IA,IL,IN,KY,LA,MA,MD,ME,MI,MN,MT,NC,NV,NY,OH,PA, TX,VA,WA,WI and Internationally to: AUSTRALIA AUSTRIA BELGIUM BRAZIL CANADA CZECH REPUBLIC DENMARK EGYPT FRANCE GERMANY GREECE HOLLAND HUNGARY INDIA IRELAND ISRAEL ITALY JAPAN KOREA MALAYSIA NEW ZEALAND NORWAY P R CHINA PAKISTAN PANAMA POLAND PORTUGAL PUERTO RICO RUSSIA SAUDI ARABIA SINGAPORE SLOVENIA SOUTH AFRICA SPAIN SWEDEN SWITZERLAND TURKEY UAE UK","Z-0420-2014","Class II","SIGMA LCS HIGH PERFORMANCE'' MBT PUNCH CEMENTED Size 4-7 HP M.B.T. Keel Punch Knee Instrument is used to prepare the proximal tibial canal geometry to accept the final or definitive tibial tray used during total knee arthroplasty. ","Item #950502018",".","29,235 units in total / 2008 through November 2013","DePuy Orthopaedics, Inc. is issuing a voluntary device correction of the HP M.B.T. Keel Punch Knee Instrument because of the potential for tabs on the connection end to fracture and be left in the patient. ",11/18/2013,"11/18/2013",12/4/2013,"12/04/2013"
"Devices",66864,"Ongoing","DePuy Orthopaedics, Inc.","Warsaw","IN","US","Voluntary: Firm Initiated",,"Worldwide Distribution - USA (nationwide) including AR,AZ,CA,CO,FL,GA,HI,IA,IL,IN,KY,LA,MA,MD,ME,MI,MN,MT,NC,NV,NY,OH,PA, TX,VA,WA,WI and Internationally to: AUSTRALIA AUSTRIA BELGIUM BRAZIL CANADA CZECH REPUBLIC DENMARK EGYPT FRANCE GERMANY GREECE HOLLAND HUNGARY INDIA IRELAND ISRAEL ITALY JAPAN KOREA MALAYSIA NEW ZEALAND NORWAY P R CHINA PAKISTAN PANAMA POLAND PORTUGAL PUERTO RICO RUSSIA SAUDI ARABIA SINGAPORE SLOVENIA SOUTH AFRICA SPAIN SWEDEN SWITZERLAND TURKEY UAE UK","Z-0413-2014","Class II","SIGMA LCS HIGH PERFORMANCE'' MBT KEEL PUNCH CEMENTED Size 2-3 HP M.B.T. Keel Punch Knee Instrument is used to prepare the proximal tibial canal geometry to accept the final or definitive tibial tray used during total knee arthroplasty","Item #950502011",".","29,235 units in total / 2008 through November 2013","DePuy Orthopaedics, Inc. is issuing a voluntary device correction of the HP M.B.T. Keel Punch Knee Instrument because of the potential for tabs on the connection end to fracture and be left in the patient. ",11/18/2013,"11/18/2013",12/4/2013,"12/04/2013"
"Devices",66866,"Ongoing","Intuitive Surgical, Inc.","Sunnyvale","CA","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution: US (nationwide) and to countries of: Australia, Austria, Belgium, Brazil, Bulgaria, Canada, China, Columbia, Denmark, France, Germany, India, Israel, Italy, Japan, S. Korea, Luxembourg, Mexico, Monaco, Netherlands, Norway, Romania. Russian Federation, Singapore, Spain, Sweden, Switzerland, Taiwan, Thailand, Turkey, and United Kingdom.","Z-0436-2014","Class II","Assembly, Patient Side Manipulator on da Vinci Surgical Systems: da Vinci S Surgical System; da Vinci SI Surgical System da Vinci Si-e Surgical System; Manufactured by Intuitive Surgical Sunnyvale, CA 94086. The Intuitive Surgical Endoscopic Instrument Control System (Intuitive Surgical da Vinci Surgical System Model IS2000/3000) is intended to assist in the accurate control of Intuitive Surgical Endoscopic Instruments including rigid endoscopes, blunt and sharp endoscopic dissectors, scissors, scalpels, ultrasonic shears, forceps/pick-ups, needle holders, endoscopic retractors, stabilizers, electro cautery and accessories for endoscopic manipulation of tissue, including grasping, cutting, blunt and sharp dissection, approximation, ligation, electro cautery, suturing, and delivery and placement of microwave and cryogenic ablation probes and accessories, during urologic surgical procedures, general laparoscopic surgical procedures, gynecologic laparoscopic surgical procedures, general cardiovascular and non-cardiovascular thoracoscopic surgical procedures and thoracoscopically-assisted cardiotomy procedures. The system is indicated for adult and pediatric use","Part number 380900-02 and 380900-03: System ID numbers - US: SH0018 SH0206 SH0407 SH0752 SH0981 SH1179 SH1417 SH1690 SH1785 SH1887 SH0022 SH0214 SH0408 SH0755 SH0983 SH1180 SH1418 SH1699 SH1786 SH1889 SH0025 SH0216 SH0409 SH0756 SH0987 SH1186 SH1430 SH1706 SH1787 SH1890 SH0030 SH0223 SH0414 SH0762 SH0989 SH1191 SH1437 SH1707 SH1789 SH1891 SH0032 SH0226 SH0423 SH0765 SH0994 SH1194 SH1441 SH1709 SH1790 SH1892 SH0036 SH0228 SH0427 SH0769 SH0997 SH1199 SH1445 SH1710 SH1791 SH1893 SH0038 SH0232 SH0428 SH0770 SH1007 SH1201 SH1448 SH1711 SH1792 SH1894 SH0040 SH0240 SH0431 SH0772 SH1011 SH1203 SH1459 SH1719 SH1793 SH1896 SH0042 SH0243 SH0436 SH0781 SH1012 SH1215 SH1461 SH1721 SH1794 SH1897 SH0049 SH0245 SH0437 SH0791 SH1013 SH1246 SH1507 SH1727 SH1795 SH1899 SH0053 SH0248 SH0438 SH0808 SH1014 SH1259 SH1517 SH1728 SH1797 SH1900 SH0055 SH0254 SH0439 SH0819 SH1016 SH1269 SH1518 SH1729 SH1798 SH1903 SH0057 SH0258 SH0448 SH0821 SH1024 SH1269 SH1531 SH1731 SH1808 SH1904 SH0060 SH0262 SH0453 SH0823 SH1027 SH1273 SH1539 SH1733 SH1809 SH1905 SH0065 SH0265 SH0454 SH0829 SH1029 SH1283 SH1564 SH1735 SH1810 SH1906 SH0066 SH0266 SH0466 SH0838 SH1030 SH1285 SH1580 SH1736 SH1811 SH1907 SH0067 SH0268 SH0473 SH0845 SH1031 SH1286 SH1581 SH1739 SH1812 SH1908 SH0068 SH0272 SH0475 SH0847 SH1032 SH1288 SH1583 SH1741 SH1814 SH1909 SH0070 SH0275 SH0489 SH0849 SH1034 SH1290 SH1589 SH1743 SH1815 SH1910 SH0076 SH0282 SH0490 SH0850 SH1036 SH1293 SH1594 SH1744 SH1817 SH1912 SH0078 SH0284 SH0493 SH0853 SH1050 SH1294 SH1598 SH1746 SH1822 SH1913 SH0082 SH0292 SH0521 SH0855 SH1053 SH1306 SH1599 SH1747 SH1823 SH1915 SH0085 SH0296 SH0524 SH0858 SH1055 SH1322 SH1605 SH1748 SH1824 SH1916 SH0108 SH0304 SH0525 SH0862 SH1059 SH1324 SH1606 SH1749 SH1827 SH1922 SH0112 SH0309 SH0527 SH0865 SH1069 SH1331 SH1612 SH1750 SH1831 SH1923 SH0113 SH0310 SH0543 SH0866 SH1080 SH1332 SH1617 SH1752 SH1840 SH1924 SH0115 SH0314 SH0548 SH0867 SH1081 SH1333 SH1629 SH1753 SH1841 SH1925 SH0134 SH0318 SH0557 SH0871 SH1082 SH1334 SH1630 SH1754 SH1842 SH1926 SH0141 SH0319 SH0577 SH0",".","1,386","Reports of friction within certain instrument arms can interrupt smooth instrument motion. This can be felt by the surgeon as resistance in the movement of the master.In this situation, the instrument can stall momentarily and then suddenly catch-up to the master position if the surgeon pushes through the resistance. ",11/11/2013,"11/11/2013",12/11/2013,"12/11/2013"
"Food",66871,"Ongoing","Crunch Pak, LLC","Cashmere","WA","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","products distributed in AL, AR, AZ, CA, CO, FL, GA, IA, IL, IN, KY, LA, MO, MS, NE, NM, NV, OH, OK, PA, TN, TX, UT, VA, WA, WI, and WY.","F-0704-2014","Class I","Crunch Pak Apple Slices with Low Fat Caramel Dip, 5/2.5 oz. Tart with Caramel Sauce. The clamshell includes 5/2 oz. bags of sliced apples and 5/ 0.5 oz. packages of caramel (sauce) dip. The UPC on the clamshell is 7 32313 09113 9. The clamshell package is labeled in parts: ''***CRUNCH PAK***TART***apple Slices***WITH LOW FAT CARAMEL DIP***5-2 oz BAGS***5-0.5 oz CARAMEL DIP***NET WT. 12.5 oz***Crunch Pak, LLC Cashmere, WA 98815***''.","Use By: 11/14/13. ",".","200 cases/8 packages/5 bags/2 oz.","Crunch Pak Apple Slices are recalled due to a potential contamination with Listeria monocytogenes. ",11/14/2013,"11/14/2013",12/11/2013,"12/11/2013"
"Food",66871,"Ongoing","Crunch Pak, LLC","Cashmere","WA","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","products distributed in AL, AR, AZ, CA, CO, FL, GA, IA, IL, IN, KY, LA, MO, MS, NE, NM, NV, OH, OK, PA, TN, TX, UT, VA, WA, WI, and WY.","F-0705-2014","Class I","Crunch Pak Honeycrisp Apple Slices, 12 ounce bag. The UPC is 7 32313 12001 3. The product is labeled in parts: ''***CRUNCH PAK***apple Slices***HONEYCRISP***NET WT. 12 oz***CRUNCH PAK, LLC***CASHMERE, WA 98815***''.","Use By: 11/14/13. ",".","2378 cases/6 bags/12 oz.","Crunch Pak Apple Slices are recalled due to a potential contamination with Listeria monocytogenes. ",11/14/2013,"11/14/2013",12/11/2013,"12/11/2013"
"Food",66871,"Ongoing","Crunch Pak, LLC","Cashmere","WA","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","products distributed in AL, AR, AZ, CA, CO, FL, GA, IA, IL, IN, KY, LA, MO, MS, NE, NM, NV, OH, OK, PA, TN, TX, UT, VA, WA, WI, and WY.","F-0706-2014","Class I","Crunch Pak Natural Blue Raspberry Flavor Sliced Apples, 5/2 oz. bags packaged in a clamshell. The lid has a Monsters University image. The clamshell package has the UPC 7 32313 08996 9. The clamshell package is labeled in parts: ''***CRUNCH PAK***flavorz***Sliced Apples with Natural Blue Raspberry Flavor***MONSTERS UNIVERSITY***5 BAGS***NET WT. 10 oz***Crunch Pak, LLC***Cashmere, WA 98815***''.","Use By: 11/18/13. ",".","922 cases/4 packages/5 bags/2 oz.","Crunch Pak Apple Slices are recalled due to a potential contamination with Listeria monocytogenes. ",11/14/2013,"11/14/2013",12/11/2013,"12/11/2013"
"Food",66871,"Ongoing","Crunch Pak, LLC","Cashmere","WA","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","products distributed in AL, AR, AZ, CA, CO, FL, GA, IA, IL, IN, KY, LA, MO, MS, NE, NM, NV, OH, OK, PA, TN, TX, UT, VA, WA, WI, and WY.","F-0707-2014","Class I","Crunch Pak Tart Apple Slices, 6/2 ounce bags packaged in a clamshell. The UPC on the clamshell is 7 32313 12103 4. Crunch Pak Tart Apple Slices, 14 ounce bag. The UPC is 7 32313 14120 9. Crunch Pak Tart Apple Slices, 3 pound bag. The UPC is 7 32313 48120 6. The 6/2 oz. bags packaged in a clamshell is labeled in parts: ''***CRUNCH PAK***TART***apple Slices***6-2 oz BAGS***NET WT. 12 oz***Crunch Pak, LLC, Cashmere, WA 98815***''. The 14 oz. bag is labeled in parts: ''***CRUNCH PAK***TART***apple Slices***NET WT. 14 oz.***Crunch Pak, LLC, Cashmere, WA 98815***''. The 3 lb. bag is labeled in part: ''***CRUNCH PAK***NET WT. 48 oz (3 LB)***WWW.CRUNCH PAK.COM***''.","Use By: 11/14/13. ",".","41 cases (8 pkg/6 bags/2 oz.); 1854 cases (6 bags/14 oz.); and 76 cases (4 bags/3 lbs.)","Crunch Pak Apple Slices are recalled due to a potential contamination with Listeria monocytogenes. ",11/14/2013,"11/14/2013",12/11/2013,"12/11/2013"
"Devices",66874,"Ongoing","Steris Corporation","Mentor","OH","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution - USA Nationwide in the states of: AL, AZ, AR, CA, CO, CT, DE, FL, GA, ID, IL, IN, KS, KY, LA, ME, MD, MA, MI, MN, MI, MO, MT, NE, NH, NJ, NM, NY, NC, ND, OH, OK, OR, PA, SC, SD, TN, TX, UT, VT, VA, WA, WV, WI, WY and the District of Columbia including the countries of: Brazil, Canada, Chile, Guam, Mexico, Saudi Arabia, United Arab Emirates & Venezuela.","Z-0478-2014","Class II","AMSCO Evolution steam sterilizer Transfer Carriage. Product Usage: Mobile, wheeled transportation unit utilized to carry, load, & unload the Loading Car into and out of steam sterilizer units. ","Serial Number Range: 030061103 - 0535531220",,"936 units","The firm discovered that unlatching can occur when overloaded transfer carriages are pulled or maneuvered incorrectly or with excessive force. ",10/18/2013,"10/18/2013",12/18/2013,"12/18/2013"
"Food",66876,"Ongoing","The New French Bakery","South San Francisco","CA","US","Voluntary: Firm Initiated","Telephone","20 retail locations in the San Francisco Bay area.","F-0730-2014","Class I","Chocolate La Boulange Soft Caramel, Net WT. 8.4 oz. (238 g); Cooked in small batches in copper pots; all natural La Boulange South San Francisco, CA","Lot code 822713",,"91 jars, 16 recovered at retail stores","Firm discovered that 8.4 oz. jars of Hazelnut Jam were produced on 8/15/13 and were mislabeled as La Boulange Soft Caramel. the Hazelnut jam contains hazelnuts which were undeclared on the label.",11/13/2013,"11/13/2013",12/18/2013,"12/18/2013"
"Devices",66882,"Ongoing","Medtronic Neurosurgery","Goleta","CA","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution - USA (nationwide) and Internationally to US and worldwide: Austria, Belgium, Bosnia, Herzegovina, Canada, Croatia, Germany, Japan, Poland, Portugal, Taiwan, United Arab Emirates, United Kingdom.","Z-0398-2014","Class II","Medtronic Delta Shunt Assembly Kit with Bioglide Small, Performance Level 1.0, Catalog No. 276201. Delta Shunt Assemblies are designed for use in shunting CSF from the lateral ventricle of the brain into the peritoneal cavity.","Lot Numbers: D01859; D11969; D15985; D25462; D37523; D42401.",".","34 units","Medtronic Neurosurgery is recalling the CSF-Unitized Shunts, Delta Shunt Assembly Kit, and the Strata II Shunt Assembly Kit because they were found to have label discrepancies. ",11/18/2013,"11/18/2013",12/4/2013,"12/04/2013"
"Devices",66882,"Ongoing","Medtronic Neurosurgery","Goleta","CA","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution - USA (nationwide) and Internationally to US and worldwide: Austria, Belgium, Bosnia, Herzegovina, Canada, Croatia, Germany, Japan, Poland, Portugal, Taiwan, United Arab Emirates, United Kingdom.","Z-0399-2014","Class II","Medtronic Strata II Shunt Assembly Kit, Small, Catalog No. 27848. Strata II Shunt Assemblies are designed to provide continued cerebrospinal fluid (CSF) flow from the ventricles of the brain into the right atrium of the heart of the peritoneal cavity.","Lot Numbers: D22311; D37565.",".","5 units","Medtronic Neurosurgery is recalling the CSF-Unitized Shunts, Delta Shunt Assembly Kit, and the Strata II Shunt Assembly Kit because they were found to have label discrepancies. ",11/18/2013,"11/18/2013",12/4/2013,"12/04/2013"
"Devices",66882,"Ongoing","Medtronic Neurosurgery","Goleta","CA","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution - USA (nationwide) and Internationally to US and worldwide: Austria, Belgium, Bosnia, Herzegovina, Canada, Croatia, Germany, Japan, Poland, Portugal, Taiwan, United Arab Emirates, United Kingdom.","Z-0397-2014","Class II","CSF-Unitized Shunt, Contoured Regular, Low Pressure, Catalog No. 46022; CSF-Unitized Shunt, Contoured Regular, Medium Pressure, Catalog No. 46024; CSF-Unitized Shunt, Contoured Regular, High Pressure, Catalog No. 46026. CSF-Unitized Shunt Kits are designed as integrated CSF-Flow Control Shunts for use in shunting cerebrospinal fluid from the lateral ventricle of the brain into the peritoneal cavity. ","Lot Numbers: Catalog No. 46022: D27162; D30984; D3461 0; D35834; D37761; D39054; D39539. Catalog No. 46024: D13944; D14093; D14217; D14216; D33526; D39540. Catalog No. 46026: D35572; D39583.",".","288 units total (147 units in US)","Medtronic Neurosurgery is recalling the CSF-Unitized Shunts, Delta Shunt Assembly Kit, and the Strata II Shunt Assembly Kit because they were found to have label discrepancies. ",11/18/2013,"11/18/2013",12/4/2013,"12/04/2013"
"Food",66884,"Ongoing","Balajee Trade Link LLC","Taylor","PA","US","Voluntary: Firm Initiated","Telephone","AZ, KY, IA, MO, NY, OH, PA, TN, TX, UT, VT","F-1114-2014","Class II","DRUK Mango Squash Contains 25% Orange Juice Net Wt. 24 fl oz. Imported by: Balajee Trade Link, LLC Scranton, PA USA Product of Bhutan","No codes identified in letter",".","25 X 12 bottles","Sample analysis FDA found the Mango Squash to contain undeclared tartrazine (FD & C Yellow #5) and sunset yellow FCF (FD & C Yellow #6)",10/29/2013,"10/29/2013",12/26/2013,"12/26/2013"
"Food",66884,"Ongoing","Balajee Trade Link LLC","Taylor","PA","US","Voluntary: Firm Initiated","Telephone","AZ, KY, IA, MO, NY, OH, PA, TN, TX, UT, VT","F-1113-2014","Class II","DRUK Orange Squash Contains 25% Orange Juice Net Wt. 24 fl oz. Imported by: Balajee Trade Link, LLC Scranton, PA USA Product of Bhutan","No codes declared in recall letter",".","63 cases 12 bottles/case","Sample analysis by FDA found the product to contain undeclared sunset yellow FCF",10/29/2013,"10/29/2013",12/26/2013,"12/26/2013"
"Devices",66885,"Ongoing","Integra LifeSciences Corp. d.b.a. Integra Pain Management","Salt Lake City","UT","US","Voluntary: Firm Initiated","Letter","USA Nationwide Distribution and one foreign consignee in Mursalat.","Z-0533-2014","Class II","Integra Disposable, Convenience Kit Single Shot Epidural Tray Reorder Number 340269 Rx Only Product Usage: The Integra kits which contain a BD LOR syringe are intended to provide licensed medical professionals with a kit containing drugs and other medical devices that are used to support the administration of general, local or spinal anesthetics. The BD LOR syringe is intended for use, in conjunction with an epidural needle, to verify the needle tip placement is in the epidural space by use of the Loss of Resistance Technique as detailed in medical textbooks and medical journal articles. The LOR Syringe is not intended for injection or aspiration. ","Kit Cat No: 10-2433,13-2595,13-2616,13-2628,3104195,3403061,3403150,3403316,3403579,3403727,3403776,3403813,3403989,3404131,3404269,3404293,3404417,3404468,3404578,3503559,CUS025,CUS1121-01,CUS1164-02,CUS1202-04,CUS1298-03,CUS1376,CUS1376,CUS1400-01,CUS1406-03,CUS1415-04,CUS1568-01,CUS1664-01,CUS1696,CUS1723,CUS1760,CUS1773-01,CUS1797,CUS279-02,CUS416,CUS597,CUS628-02,CUS755,PISLL7,RSM394,RSM395,SS1246,SS2036-01,",".","359,250 ","Integra LifeSciences Corporation is recalling certain lots of Integra Kits for Epidural Anesthesia Administration as a result of a Product Advisory Notice from BD Medical for the LOR syringes indicating the plunger of the syringe may stall or stick when travelling within the syringe.",10/28/2013,"10/28/2013",12/26/2013,"12/26/2013"
"Devices",66886,"Ongoing","Abbott Diabetes Care, Inc.","Alameda","CA","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution - USA (nationwide and Puerto Rico) and Internationally to Australia, Austria, Belgium, Denmark, Egypt, Finland, France, Germany, Jamaica, Ireland, Israel, United Kingdom, Luxembourg, Netherlands, Norway, Sweden, Switzerland, UAE, and Canada. **Center Recommended Depth - Consumers/User**","Z-0485-2014","Class I","FreeStyle Blood Glucose Test Strips; For in vitro diagnostic testing. 50 count UPC 6 99073 12050 2; Freestyle Blood Glucose Test Strips; for Institutional Use only 50 count: UPC 6 99073 70792 5 Manufactured by Abbott Diabetes Care Inc. Alameda, CA. The FreeStyle Blood Glucose test strip is intended for use in the quantitative measurement of glucose in capillary whole blood from the finger, upper arm and palm. It is intended for use by healthcare professionals and people with diabetes mellitus at home as an aid in monitoring the effectiveness of a diabetes control program. It is not intended for the diagnosis of or screening for diabetes mellitus, and it is not intended for use on neonates or arterial blood.","Part number 12050-21: Lot number: 1285007 Exp. date: 2014/06; Part number 70792-20 (instuitional use) Lot number: 1373262, Exp. Date 2015/02",".","141,219 cartons for human use - all lot numbers","Certain lots of FreeStyle and FreeStyle Lite Blood Glucose Test Strips produce erroneously low blood glucose results when using FreeStyle Blood Glucose Meters, FreeStyle Flash Blood Glucose Meters and the FreeStyle blood glucose meter built into the OmniPod system. Erroneously low results that are not recognized may pose significant risks to your health. ",11/18/2013,"11/18/2013",12/26/2013,"12/26/2013"
"Devices",66886,"Ongoing","Abbott Diabetes Care, Inc.","Alameda","CA","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution - USA (nationwide and Puerto Rico) and Internationally to Australia, Austria, Belgium, Denmark, Egypt, Finland, France, Germany, Jamaica, Ireland, Israel, United Kingdom, Luxembourg, Netherlands, Norway, Sweden, Switzerland, UAE, and Canada. **Center Recommended Depth - Consumers/User**","Z-0486-2014","Class I","FreeStyle Lite Blood Glucose Test Strips; For in vitro diagnostic testing. 50 count; 100 count Product of Ireland; UPC 6 99073 70819 9; - 50 count UPC 6 99073 70822 9 - 50 count UPC 6 99073 71026 0 - 50 count UPC 6 99073 70827 4 - 100 count Manufactured by Abbott Diabetes Care Inc. Alameda, CA. The FreeStyle Blood Glucose test strip is intended for use in the quantitative measurement of glucose in capillary whole blood from the finger, upper arm and palm. It is intended for use by healthcare professionals and people with diabetes mellitus at home as an aid in monitoring the effectiveness of a diabetes control program. It is not intended for the diagnosis of or screening for diabetes mellitus, and it is not intended for use on neonates or arterial blood.","Part number: 71026-70; Lot number: 1281732; Exp. date: 2014/05; Lot number: 1283603; Exp. date: 2014/06; Part number: 70827-71: Lot number: 1363015, Exp. Date: 2014/11; Lot number: 1363109, Exp. Date 2014/11: Lot number: 1365921, Exp. Date 2014/12; Part number 70827-72: Lot number: 1366006 Exp. Date : 2014/12; Lot number 1366111, Exp. Date: 2014/12; Lot number 1366337; Exp. Date: 2014/12; Lot number: 1366515, Exp Date: 2014/12; Part number 70822-71; Lot number 1283345: Exp. Date: 2014/05; Lot number 1365920; Exp. Date: 2014/12; Lot number 1365934; Exp. Date: 2014/12; Part number: 70822-72: Lot number: 1350414: Exp Date: 2014/07; Lot number 1363321; Exp. Date 2014/11: Part number: 70819-70: Lot Number: 1365056: Exp. Date 2014/11; Lot number: 1366347: Exp. Date: 2014/12; Lot number: 1367917; Exp. Date 2014/12 Lot number: 1374907; Exp. Date 2015/03.",".","141,219 cartons for human use - total","Certain lots of FreeStyle and FreeStyle Lite Blood Glucose Test Strips produce erroneously low blood glucose results when using FreeStyle Blood Glucose Meters, FreeStyle Flash Blood Glucose Meters and the FreeStyle blood glucose meter built into the OmniPod system. Erroneously low results that are not recognized may pose significant risks to your health. ",11/18/2013,"11/18/2013",12/26/2013,"12/26/2013"
"Food",66887,"Ongoing","S & M International Inc","Bayonne","NJ","US","Voluntary: Firm Initiated","Letter","NY","F-0830-2014","Class I","Grove Grow Notes Fruit of Wolfberry (Fructus Lycii) Net Wt: 12 oz (340g) S & M (USA) Enterprise 4703 2nd Avenue Brooklyn, NY 11232 UPC 4580158101515 S & M (HK) Enterprise Ltd Rm, 3.8/F., Yue Xiu Bldg., 160-174Lockhart Road, Wan Chai, HK Product of China","All lots",".","100 cases ","NYSDAM Sampling results has revealed the presence of undeclared sulfites in Fruit of Wolfberry.",11/4/2013,"11/04/2013",12/26/2013,"12/26/2013"
"Devices",66888,"Ongoing","Stryker Neurovascular","Fremont","CA","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution - USa (nationwide) and Internationally to: Austria, Belgium, Czech Rep, Germany, France, Great Britain, Hungary, Italy, Lithuania, Netherlands, Norway, Poland, Slovakia, Spain, Turkey, Australia, Canada, Chile, Hong Kong, India, Korea, Malaysia, Russia and Japan","Z-0502-2014","Class II","Stryker brand GDC-10 ULTRA SOFT 2MM X 3CM, Catalog Number: M0033432030; Product is manufactured by Stryker Neurovascular, Cork, Ireland and distributed by Stryker Neurovascular, Fremont, CA Excelsior SL-10/Excelsior 1018 Microcatheter: Stryker Neurovascular Microcatheters are intended to assist in the delivery of diagnostic agents, such as contrast media, and therapeutic agents, such as occlusion coils, into the peripheral, coronary, and neurovasculature. GDC 10, 18 Coils: The Gugliemi Detachable Coil is intended for the endovascular embolization of: (1) Intracranial aneurysms, (2) Other neurovascular abnormalities such as arteriovenous malformations and arteriovenous fistula, (3) Arterial and venous embolizations in the peripheral vasculature GDC 18-Fibered VortX Shape Coil: The GDC 18-Fibered VortX Shape Coil is intended for embolization of vascular abnormalities such as (1) Arteriovenous malformations and arteriovenous fistulae of the neurovasculature; (2) GDC 18- Fibered VoliX Shape Coil is also intended for arterial and venous embolizations in the peripheral vasculature. Transform: The Stryker Neurovascular TransForm Occlusion Balloon Catheters are indicated for use in the neurovasculature to temporarily stop or control blood flow and for balloon assisted embolization of aneurysms. ","17008494",".",,"Products were shipped labeled with ''use by'' dates that exceed currently available shelf-life data. All products remain within the earliest expiration date of April 2015.",11/4/2013,"11/04/2013",12/26/2013,"12/26/2013"
"Devices",66888,"Ongoing","Stryker Neurovascular","Fremont","CA","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution - USa (nationwide) and Internationally to: Austria, Belgium, Czech Rep, Germany, France, Great Britain, Hungary, Italy, Lithuania, Netherlands, Norway, Poland, Slovakia, Spain, Turkey, Australia, Canada, Chile, Hong Kong, India, Korea, Malaysia, Russia and Japan","Z-0504-2014","Class II","Stryker brand GDC VORTX 2MM X 3MM, Catalog Number: M00335302340; Product is manufactured by Stryker Neurovascular, Cork, Ireland and distributed by Stryker Neurovascular, Fremont, CA Excelsior SL-10/Excelsior 1018 Microcatheter: Stryker Neurovascular Microcatheters are intended to assist in the delivery of diagnostic agents, such as contrast media, and therapeutic agents, such as occlusion coils, into the peripheral, coronary, and neurovasculature. GDC 10, 18 Coils: The Gugliemi Detachable Coil is intended for the endovascular embolization of: (1) Intracranial aneurysms, (2) Other neurovascular abnormalities such as arteriovenous malformations and arteriovenous fistula, (3) Arterial and venous embolizations in the peripheral vasculature GDC 18-Fibered VortX Shape Coil: The GDC 18-Fibered VortX Shape Coil is intended for embolization of vascular abnormalities such as (1) Arteriovenous malformations and arteriovenous fistulae of the neurovasculature; (2) GDC 18- Fibered VoliX Shape Coil is also intended for arterial and venous embolizations in the peripheral vasculature. Transform: The Stryker Neurovascular TransForm Occlusion Balloon Catheters are indicated for use in the neurovasculature to temporarily stop or control blood flow and for balloon assisted embolization of aneurysms. ","17008662",".",,"Products were shipped labeled with ''use by'' dates that exceed currently available shelf-life data. All products remain within the earliest expiration date of April 2015.",11/4/2013,"11/04/2013",12/26/2013,"12/26/2013"
"Devices",66888,"Ongoing","Stryker Neurovascular","Fremont","CA","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution - USa (nationwide) and Internationally to: Austria, Belgium, Czech Rep, Germany, France, Great Britain, Hungary, Italy, Lithuania, Netherlands, Norway, Poland, Slovakia, Spain, Turkey, Australia, Canada, Chile, Hong Kong, India, Korea, Malaysia, Russia and Japan","Z-0497-2014","Class II","Stryker brand EXCELSIOR SL-10 PRE-SHAPED S 15OCM; Catalog Number: M0031441920; Product is manufactured by Stryker Neurovascular, Cork, Ireland and distributed by Stryker Neurovascular, Fremont, CA Excelsior SL-10/Excelsior 1018 Microcatheter: Stryker Neurovascular Microcatheters are intended to assist in the delivery of diagnostic agents, such as contrast media, and therapeutic agents, such as occlusion coils, into the peripheral, coronary, and neurovasculature. GDC 10, 18 Coils: The Gugliemi Detachable Coil is intended for the endovascular embolization of: (1) Intracranial aneurysms, (2) Other neurovascular abnormalities such as arteriovenous malformations and arteriovenous fistula, (3) Arterial and venous embolizations in the peripheral vasculature GDC 18-Fibered VortX Shape Coil: The GDC 18-Fibered VortX Shape Coil is intended for embolization of vascular abnormalities such as (1) Arteriovenous malformations and arteriovenous fistulae of the neurovasculature; (2) GDC 18- Fibered VoliX Shape Coil is also intended for arterial and venous embolizations in the peripheral vasculature. Transform: The Stryker Neurovascular TransForm Occlusion Balloon Catheters are indicated for use in the neurovasculature to temporarily stop or control blood flow and for balloon assisted embolization of aneurysms. ","17048727",".",,"Products were shipped labeled with ''use by'' dates that exceed currently available shelf-life data. All products remain within the earliest expiration date of April 2015.",11/4/2013,"11/04/2013",12/26/2013,"12/26/2013"
"Devices",66888,"Ongoing","Stryker Neurovascular","Fremont","CA","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution - USa (nationwide) and Internationally to: Austria, Belgium, Czech Rep, Germany, France, Great Britain, Hungary, Italy, Lithuania, Netherlands, Norway, Poland, Slovakia, Spain, Turkey, Australia, Canada, Chile, Hong Kong, India, Korea, Malaysia, Russia and Japan","Z-0505-2014","Class II","Stryker brand COMPLIANT 4MM X 10MM, Catalog Number: M003SRC04100; Product is manufactured by Stryker Neurovascular, Cork, Ireland and distributed by Stryker Neurovascular, Fremont, CA Excelsior SL-10/Excelsior 1018 Microcatheter: Stryker Neurovascular Microcatheters are intended to assist in the delivery of diagnostic agents, such as contrast media, and therapeutic agents, such as occlusion coils, into the peripheral, coronary, and neurovasculature. GDC 10, 18 Coils: The Gugliemi Detachable Coil is intended for the endovascular embolization of: (1) Intracranial aneurysms, (2) Other neurovascular abnormalities such as arteriovenous malformations and arteriovenous fistula, (3) Arterial and venous embolizations in the peripheral vasculature GDC 18-Fibered VortX Shape Coil: The GDC 18-Fibered VortX Shape Coil is intended for embolization of vascular abnormalities such as (1) Arteriovenous malformations and arteriovenous fistulae of the neurovasculature; (2) GDC 18- Fibered VoliX Shape Coil is also intended for arterial and venous embolizations in the peripheral vasculature. Transform: The Stryker Neurovascular TransForm Occlusion Balloon Catheters are indicated for use in the neurovasculature to temporarily stop or control blood flow and for balloon assisted embolization of aneurysms. ","17011012",".",,"Products were shipped labeled with ''use by'' dates that exceed currently available shelf-life data. All products remain within the earliest expiration date of April 2015.",11/4/2013,"11/04/2013",12/26/2013,"12/26/2013"
"Devices",66888,"Ongoing","Stryker Neurovascular","Fremont","CA","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution - USa (nationwide) and Internationally to: Austria, Belgium, Czech Rep, Germany, France, Great Britain, Hungary, Italy, Lithuania, Netherlands, Norway, Poland, Slovakia, Spain, Turkey, Australia, Canada, Chile, Hong Kong, India, Korea, Malaysia, Russia and Japan","Z-0506-2014","Class II","Stryker brand COMPLIANT 4MM X 15MM, Catalog Number: M003SRC04150; Product is manufactured by Stryker Neurovascular, Cork, Ireland and distributed by Excelsior SL-10/Excelsior 1018 Microcatheter: Stryker Neurovascular Microcatheters are intended to assist in the delivery of diagnostic agents, such as contrast media, and therapeutic agents, such as occlusion coils, into the peripheral, coronary, and neurovasculature. GDC 10, 18 Coils: The Gugliemi Detachable Coil is intended for the endovascular embolization of: (1) Intracranial aneurysms, (2) Other neurovascular abnormalities such as arteriovenous malformations and arteriovenous fistula, (3) Arterial and venous embolizations in the peripheral vasculature GDC 18-Fibered VortX Shape Coil: The GDC 18-Fibered VortX Shape Coil is intended for embolization of vascular abnormalities such as (1) Arteriovenous malformations and arteriovenous fistulae of the neurovasculature; (2) GDC 18- Fibered VoliX Shape Coil is also intended for arterial and venous embolizations in the peripheral vasculature. Transform: The Stryker Neurovascular TransForm Occlusion Balloon Catheters are indicated for use in the neurovasculature to temporarily stop or control blood flow and for balloon assisted embolization of aneurysms. ","17012263",".",,"Products were shipped labeled with ''use by'' dates that exceed currently available shelf-life data. All products remain within the earliest expiration date of April 2015.",11/4/2013,"11/04/2013",12/26/2013,"12/26/2013"
"Devices",66888,"Ongoing","Stryker Neurovascular","Fremont","CA","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution - USa (nationwide) and Internationally to: Austria, Belgium, Czech Rep, Germany, France, Great Britain, Hungary, Italy, Lithuania, Netherlands, Norway, Poland, Slovakia, Spain, Turkey, Australia, Canada, Chile, Hong Kong, India, Korea, Malaysia, Russia and Japan","Z-0500-2014","Class II","Stryker brand EXCELSIOR SL-10 PRE-SHAPED 90 150CM, Catalog Number: M0031681910; Product is manufactured by Stryker Neurovascular, Cork, Ireland and distributed by Stryker Neurovascular, Fremont, CA Excelsior SL-10/Excelsior 1018 Microcatheter: Stryker Neurovascular Microcatheters are intended to assist in the delivery of diagnostic agents, such as contrast media, and therapeutic agents, such as occlusion coils, into the peripheral, coronary, and neurovasculature. GDC 10, 18 Coils: The Gugliemi Detachable Coil is intended for the endovascular embolization of: (1) Intracranial aneurysms, (2) Other neurovascular abnormalities such as arteriovenous malformations and arteriovenous fistula, (3) Arterial and venous embolizations in the peripheral vasculature GDC 18-Fibered VortX Shape Coil: The GDC 18-Fibered VortX Shape Coil is intended for embolization of vascular abnormalities such as (1) Arteriovenous malformations and arteriovenous fistulae of the neurovasculature; (2) GDC 18- Fibered VoliX Shape Coil is also intended for arterial and venous embolizations in the peripheral vasculature. Transform: The Stryker Neurovascular TransForm Occlusion Balloon Catheters are indicated for use in the neurovasculature to temporarily stop or control blood flow and for balloon assisted embolization of aneurysms. ","17028950, 17030892, 17045869, 17045914, 17045959 ",".",,"Products were shipped labeled with ''use by'' dates that exceed currently available shelf-life data. All products remain within the earliest expiration date of April 2015.",11/4/2013,"11/04/2013",12/26/2013,"12/26/2013"
"Devices",66888,"Ongoing","Stryker Neurovascular","Fremont","CA","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution - USa (nationwide) and Internationally to: Austria, Belgium, Czech Rep, Germany, France, Great Britain, Hungary, Italy, Lithuania, Netherlands, Norway, Poland, Slovakia, Spain, Turkey, Australia, Canada, Chile, Hong Kong, India, Korea, Malaysia, Russia and Japan","Z-0499-2014","Class II","Stryker brand EXCELSIOR SL-10 PRE-SHAPED 45 150CM, Catalog Number: M0031681900, Product is manufactured by Stryker Neurovascular, Cork, Ireland and distributed by Stryker Neurovascular, Fremont, CA Excelsior SL-10/Excelsior 1018 Microcatheter: Stryker Neurovascular Microcatheters are intended to assist in the delivery of diagnostic agents, such as contrast media, and therapeutic agents, such as occlusion coils, into the peripheral, coronary, and neurovasculature. GDC 10, 18 Coils: The Gugliemi Detachable Coil is intended for the endovascular embolization of: (1) Intracranial aneurysms, (2) Other neurovascular abnormalities such as arteriovenous malformations and arteriovenous fistula, (3) Arterial and venous embolizations in the peripheral vasculature GDC 18-Fibered VortX Shape Coil: The GDC 18-Fibered VortX Shape Coil is intended for embolization of vascular abnormalities such as (1) Arteriovenous malformations and arteriovenous fistulae of the neurovasculature; (2) GDC 18- Fibered VoliX Shape Coil is also intended for arterial and venous embolizations in the peripheral vasculature. Transform: The Stryker Neurovascular TransForm Occlusion Balloon Catheters are indicated for use in the neurovasculature to temporarily stop or control blood flow and for balloon assisted embolization of aneurysms. ","17026849, 17026939, 17026984, 17026974 ",".",,"Products were shipped labeled with ''use by'' dates that exceed currently available shelf-life data. All products remain within the earliest expiration date of April 2015.",11/4/2013,"11/04/2013",12/26/2013,"12/26/2013"
"Devices",66888,"Ongoing","Stryker Neurovascular","Fremont","CA","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution - USa (nationwide) and Internationally to: Austria, Belgium, Czech Rep, Germany, France, Great Britain, Hungary, Italy, Lithuania, Netherlands, Norway, Poland, Slovakia, Spain, Turkey, Australia, Canada, Chile, Hong Kong, India, Korea, Malaysia, Russia and Japan","Z-0503-2014","Class II","Stryker brand GDC-18 360 18MM X 30CM, Catalog Number: M00334818300; Product is manufactured by Stryker Neurovascular, Cork, Ireland and distributed by Stryker Neurovascular, Fremont, CA Excelsior SL-10/Excelsior 1018 Microcatheter: Stryker Neurovascular Microcatheters are intended to assist in the delivery of diagnostic agents, such as contrast media, and therapeutic agents, such as occlusion coils, into the peripheral, coronary, and neurovasculature. GDC 10, 18 Coils: The Gugliemi Detachable Coil is intended for the endovascular embolization of: (1) Intracranial aneurysms, (2) Other neurovascular abnormalities such as arteriovenous malformations and arteriovenous fistula, (3) Arterial and venous embolizations in the peripheral vasculature GDC 18-Fibered VortX Shape Coil: The GDC 18-Fibered VortX Shape Coil is intended for embolization of vascular abnormalities such as (1) Arteriovenous malformations and arteriovenous fistulae of the neurovasculature; (2) GDC 18- Fibered VoliX Shape Coil is also intended for arterial and venous embolizations in the peripheral vasculature. Transform: The Stryker Neurovascular TransForm Occlusion Balloon Catheters are indicated for use in the neurovasculature to temporarily stop or control blood flow and for balloon assisted embolization of aneurysms. ","17008718",".",,"Products were shipped labeled with ''use by'' dates that exceed currently available shelf-life data. All products remain within the earliest expiration date of April 2015.",11/4/2013,"11/04/2013",12/26/2013,"12/26/2013"
"Devices",66888,"Ongoing","Stryker Neurovascular","Fremont","CA","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution - USa (nationwide) and Internationally to: Austria, Belgium, Czech Rep, Germany, France, Great Britain, Hungary, Italy, Lithuania, Netherlands, Norway, Poland, Slovakia, Spain, Turkey, Australia, Canada, Chile, Hong Kong, India, Korea, Malaysia, Russia and Japan","Z-0494-2014","Class II","Stryker brand EXCELSIOR 1018 PRE-SHAPED 45 150CM, Catalog Number: M0031441900; Product is manufactured by Stryker Neurovascular, Cork, Ireland and distributed by Stryker Neurovascular, Fremont, CA Excelsior SL-10/Excelsior 1018 Microcatheter: Stryker Neurovascular Microcatheters are intended to assist in the delivery of diagnostic agents, such as contrast media, and therapeutic agents, such as occlusion coils, into the peripheral, coronary, and neurovasculature. GDC 10, 18 Coils: The Gugliemi Detachable Coil is intended for the endovascular embolization of: (1) Intracranial aneurysms, (2) Other neurovascular abnormalities such as arteriovenous malformations and arteriovenous fistula, (3) Arterial and venous embolizations in the peripheral vasculature GDC 18-Fibered VortX Shape Coil: The GDC 18-Fibered VortX Shape Coil is intended for embolization of vascular abnormalities such as (1) Arteriovenous malformations and arteriovenous fistulae of the neurovasculature; (2) GDC 18- Fibered VoliX Shape Coil is also intended for arterial and venous embolizations in the peripheral vasculature. Transform: The Stryker Neurovascular TransForm Occlusion Balloon Catheters are indicated for use in the neurovasculature to temporarily stop or control blood flow and for balloon assisted embolization of aneurysms. ","17013021, 17013156, 17020618, 17020619, 17020620 ",".",,"Products were shipped labeled with ''use by'' dates that exceed currently available shelf-life data. All products remain within the earliest expiration date of April 2015.",11/4/2013,"11/04/2013",12/26/2013,"12/26/2013"
"Devices",66888,"Ongoing","Stryker Neurovascular","Fremont","CA","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution - USa (nationwide) and Internationally to: Austria, Belgium, Czech Rep, Germany, France, Great Britain, Hungary, Italy, Lithuania, Netherlands, Norway, Poland, Slovakia, Spain, Turkey, Australia, Canada, Chile, Hong Kong, India, Korea, Malaysia, Russia and Japan","Z-0495-2014","Class II","Stryker brand EXCELSIOR SL-10 PRE-SHAPED J 15OCM; Catalog Number: M0031441930; Product is manufactured by Stryker Neurovascular, Cork, Ireland and distributed by Stryker Neurovascular, Fremont, CA Excelsior SL-10/Excelsior 1018 Microcatheter: Stryker Neurovascular Microcatheters are intended to assist in the delivery of diagnostic agents, such as contrast media, and therapeutic agents, such as occlusion coils, into the peripheral, coronary, and neurovasculature. GDC 10, 18 Coils: The Gugliemi Detachable Coil is intended for the endovascular embolization of: (1) Intracranial aneurysms, (2) Other neurovascular abnormalities such as arteriovenous malformations and arteriovenous fistula, (3) Arterial and venous embolizations in the peripheral vasculature GDC 18-Fibered VortX Shape Coil: The GDC 18-Fibered VortX Shape Coil is intended for embolization of vascular abnormalities such as (1) Arteriovenous malformations and arteriovenous fistulae of the neurovasculature; (2) GDC 18- Fibered VoliX Shape Coil is also intended for arterial and venous embolizations in the peripheral vasculature. Transform: The Stryker Neurovascular TransForm Occlusion Balloon Catheters are indicated for use in the neurovasculature to temporarily stop or control blood flow and for balloon assisted embolization of aneurysms. ","17048723",".",,"Products were shipped labeled with ''use by'' dates that exceed currently available shelf-life data. All products remain within the earliest expiration date of April 2015.",11/4/2013,"11/04/2013",12/26/2013,"12/26/2013"
"Devices",66888,"Ongoing","Stryker Neurovascular","Fremont","CA","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution - USa (nationwide) and Internationally to: Austria, Belgium, Czech Rep, Germany, France, Great Britain, Hungary, Italy, Lithuania, Netherlands, Norway, Poland, Slovakia, Spain, Turkey, Australia, Canada, Chile, Hong Kong, India, Korea, Malaysia, Russia and Japan","Z-0509-2014","Class II","Stryker brand COMPLIANT 5MM X 15MM, Catalog Number: M003SRC05150; Product is manufactured by Stryker Neurovascular, Cork, Ireland and distributed by Stryker Neurovascular, Fremont, CA Excelsior SL-10/Excelsior 1018 Microcatheter: Stryker Neurovascular Microcatheters are intended to assist in the delivery of diagnostic agents, such as contrast media, and therapeutic agents, such as occlusion coils, into the peripheral, coronary, and neurovasculature. GDC 10, 18 Coils: The Gugliemi Detachable Coil is intended for the endovascular embolization of: (1) Intracranial aneurysms, (2) Other neurovascular abnormalities such as arteriovenous malformations and arteriovenous fistula, (3) Arterial and venous embolizations in the peripheral vasculature GDC 18-Fibered VortX Shape Coil: The GDC 18-Fibered VortX Shape Coil is intended for embolization of vascular abnormalities such as (1) Arteriovenous malformations and arteriovenous fistulae of the neurovasculature; (2) GDC 18- Fibered VoliX Shape Coil is also intended for arterial and venous embolizations in the peripheral vasculature. Transform: The Stryker Neurovascular TransForm Occlusion Balloon Catheters are indicated for use in the neurovasculature to temporarily stop or control blood flow and for balloon assisted embolization of aneurysms. ","17010749",".",,"Products were shipped labeled with ''use by'' dates that exceed currently available shelf-life data. All products remain within the earliest expiration date of April 2015.",11/4/2013,"11/04/2013",12/26/2013,"12/26/2013"
"Devices",66888,"Ongoing","Stryker Neurovascular","Fremont","CA","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution - USa (nationwide) and Internationally to: Austria, Belgium, Czech Rep, Germany, France, Great Britain, Hungary, Italy, Lithuania, Netherlands, Norway, Poland, Slovakia, Spain, Turkey, Australia, Canada, Chile, Hong Kong, India, Korea, Malaysia, Russia and Japan","Z-0512-2014","Class II","Stryker brand SUPER COMPLIANT 7MM X 15MM, Catalog Number: M003SSC07150; Product is manufactured by Stryker Neurovascular, Cork, Ireland and distributed by Stryker Neurovascular, Fremont, CA Excelsior SL-10/Excelsior 1018 Microcatheter: Stryker Neurovascular Microcatheters are intended to assist in the delivery of diagnostic agents, such as contrast media, and therapeutic agents, such as occlusion coils, into the peripheral, coronary, and neurovasculature. GDC 10, 18 Coils: The Gugliemi Detachable Coil is intended for the endovascular embolization of: (1) Intracranial aneurysms, (2) Other neurovascular abnormalities such as arteriovenous malformations and arteriovenous fistula, (3) Arterial and venous embolizations in the peripheral vasculature GDC 18-Fibered VortX Shape Coil: The GDC 18-Fibered VortX Shape Coil is intended for embolization of vascular abnormalities such as (1) Arteriovenous malformations and arteriovenous fistulae of the neurovasculature; (2) GDC 18- Fibered VoliX Shape Coil is also intended for arterial and venous embolizations in the peripheral vasculature. Transform: The Stryker Neurovascular TransForm Occlusion Balloon Catheters are indicated for use in the neurovasculature to temporarily stop or control blood flow and for balloon assisted embolization of aneurysms. ","17010924",".",,"Products were shipped labeled with ''use by'' dates that exceed currently available shelf-life data. All products remain within the earliest expiration date of April 2015.",11/4/2013,"11/04/2013",12/26/2013,"12/26/2013"
"Devices",66888,"Ongoing","Stryker Neurovascular","Fremont","CA","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution - USa (nationwide) and Internationally to: Austria, Belgium, Czech Rep, Germany, France, Great Britain, Hungary, Italy, Lithuania, Netherlands, Norway, Poland, Slovakia, Spain, Turkey, Australia, Canada, Chile, Hong Kong, India, Korea, Malaysia, Russia and Japan","Z-0501-2014","Class II","Stryker brand EXCELSIOR SL-10 PRE-SHAPED J 15OCM, Catalog Number: M0031681920; Product is manufactured by Stryker Neurovascular, Cork, Ireland and distributed by Stryker Neurovascular, Fremont, CA Excelsior SL-10/Excelsior 1018 Microcatheter: Stryker Neurovascular Microcatheters are intended to assist in the delivery of diagnostic agents, such as contrast media, and therapeutic agents, such as occlusion coils, into the peripheral, coronary, and neurovasculature. GDC 10, 18 Coils: The Gugliemi Detachable Coil is intended for the endovascular embolization of: (1) Intracranial aneurysms, (2) Other neurovascular abnormalities such as arteriovenous malformations and arteriovenous fistula, (3) Arterial and venous embolizations in the peripheral vasculature GDC 18-Fibered VortX Shape Coil: The GDC 18-Fibered VortX Shape Coil is intended for embolization of vascular abnormalities such as (1) Arteriovenous malformations and arteriovenous fistulae of the neurovasculature; (2) GDC 18- Fibered VoliX Shape Coil is also intended for arterial and venous embolizations in the peripheral vasculature. Transform: The Stryker Neurovascular TransForm Occlusion Balloon Catheters are indicated for use in the neurovasculature to temporarily stop or control blood flow and for balloon assisted embolization of aneurysms. ","17046094, 17046139, 17046184, 17046229, 17046274 ",".",,"Products were shipped labeled with ''use by'' dates that exceed currently available shelf-life data. All products remain within the earliest expiration date of April 2015.",11/4/2013,"11/04/2013",12/26/2013,"12/26/2013"
"Devices",66888,"Ongoing","Stryker Neurovascular","Fremont","CA","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution - USa (nationwide) and Internationally to: Austria, Belgium, Czech Rep, Germany, France, Great Britain, Hungary, Italy, Lithuania, Netherlands, Norway, Poland, Slovakia, Spain, Turkey, Australia, Canada, Chile, Hong Kong, India, Korea, Malaysia, Russia and Japan","Z-0510-2014","Class II","Stryker brand COMPLIANT 5MM X 30MM, Catalog Number: M003SRC05300; Product is manufactured by Stryker Neurovascular, Cork, Ireland and distributed by Stryker Neurovascular, Fremont, CA Excelsior SL-10/Excelsior 1018 Microcatheter: Stryker Neurovascular Microcatheters are intended to assist in the delivery of diagnostic agents, such as contrast media, and therapeutic agents, such as occlusion coils, into the peripheral, coronary, and neurovasculature. GDC 10, 18 Coils: The Gugliemi Detachable Coil is intended for the endovascular embolization of: (1) Intracranial aneurysms, (2) Other neurovascular abnormalities such as arteriovenous malformations and arteriovenous fistula, (3) Arterial and venous embolizations in the peripheral vasculature GDC 18-Fibered VortX Shape Coil: The GDC 18-Fibered VortX Shape Coil is intended for embolization of vascular abnormalities such as (1) Arteriovenous malformations and arteriovenous fistulae of the neurovasculature; (2) GDC 18- Fibered VoliX Shape Coil is also intended for arterial and venous embolizations in the peripheral vasculature. Transform: The Stryker Neurovascular TransForm Occlusion Balloon Catheters are indicated for use in the neurovasculature to temporarily stop or control blood flow and for balloon assisted embolization of aneurysms. ","17011548",".",,"Products were shipped labeled with ''use by'' dates that exceed currently available shelf-life data. All products remain within the earliest expiration date of April 2015.",11/4/2013,"11/04/2013",12/26/2013,"12/26/2013"
"Devices",66888,"Ongoing","Stryker Neurovascular","Fremont","CA","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution - USa (nationwide) and Internationally to: Austria, Belgium, Czech Rep, Germany, France, Great Britain, Hungary, Italy, Lithuania, Netherlands, Norway, Poland, Slovakia, Spain, Turkey, Australia, Canada, Chile, Hong Kong, India, Korea, Malaysia, Russia and Japan","Z-0496-2014","Class II","Stryker brand EXCELSIOR SL-10 PRE-SHAPED C 15OCM; Catalog Number: M0031441940; Product is manufactured by Stryker Neurovascular, Cork, Ireland and distributed by Stryker Neurovascular, Fremont, CA Excelsior SL-10/Excelsior 1018 Microcatheter: Stryker Neurovascular Microcatheters are intended to assist in the delivery of diagnostic agents, such as contrast media, and therapeutic agents, such as occlusion coils, into the peripheral, coronary, and neurovasculature. GDC 10, 18 Coils: The Gugliemi Detachable Coil is intended for the endovascular embolization of: (1) Intracranial aneurysms, (2) Other neurovascular abnormalities such as arteriovenous malformations and arteriovenous fistula, (3) Arterial and venous embolizations in the peripheral vasculature GDC 18-Fibered VortX Shape Coil: The GDC 18-Fibered VortX Shape Coil is intended for embolization of vascular abnormalities such as (1) Arteriovenous malformations and arteriovenous fistulae of the neurovasculature; (2) GDC 18- Fibered VoliX Shape Coil is also intended for arterial and venous embolizations in the peripheral vasculature. Transform: The Stryker Neurovascular TransForm Occlusion Balloon Catheters are indicated for use in the neurovasculature to temporarily stop or control blood flow and for balloon assisted embolization of aneurysms. ","17048725",".",,"Products were shipped labeled with ''use by'' dates that exceed currently available shelf-life data. All products remain within the earliest expiration date of April 2015.",11/4/2013,"11/04/2013",12/26/2013,"12/26/2013"
"Devices",66888,"Ongoing","Stryker Neurovascular","Fremont","CA","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution - USa (nationwide) and Internationally to: Austria, Belgium, Czech Rep, Germany, France, Great Britain, Hungary, Italy, Lithuania, Netherlands, Norway, Poland, Slovakia, Spain, Turkey, Australia, Canada, Chile, Hong Kong, India, Korea, Malaysia, Russia and Japan","Z-0507-2014","Class II","Stryker brand COMPLIANT 4MM X 20MM, Catalog Number: M003SRC04200; Product is manufactured by Stryker Neurovascular, Cork, Ireland and distributed by Stryker Neurovascular, Fremont, CA Excelsior SL-10/Excelsior 1018 Microcatheter: Stryker Neurovascular Microcatheters are intended to assist in the delivery of diagnostic agents, such as contrast media, and therapeutic agents, such as occlusion coils, into the peripheral, coronary, and neurovasculature. GDC 10, 18 Coils: The Gugliemi Detachable Coil is intended for the endovascular embolization of: (1) Intracranial aneurysms, (2) Other neurovascular abnormalities such as arteriovenous malformations and arteriovenous fistula, (3) Arterial and venous embolizations in the peripheral vasculature GDC 18-Fibered VortX Shape Coil: The GDC 18-Fibered VortX Shape Coil is intended for embolization of vascular abnormalities such as (1) Arteriovenous malformations and arteriovenous fistulae of the neurovasculature; (2) GDC 18- Fibered VoliX Shape Coil is also intended for arterial and venous embolizations in the peripheral vasculature. Transform: The Stryker Neurovascular TransForm Occlusion Balloon Catheters are indicated for use in the neurovasculature to temporarily stop or control blood flow and for balloon assisted embolization of aneurysms. ","17010968",".",,"Products were shipped labeled with ''use by'' dates that exceed currently available shelf-life data. All products remain within the earliest expiration date of April 2015.",11/4/2013,"11/04/2013",12/26/2013,"12/26/2013"
"Devices",66888,"Ongoing","Stryker Neurovascular","Fremont","CA","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution - USa (nationwide) and Internationally to: Austria, Belgium, Czech Rep, Germany, France, Great Britain, Hungary, Italy, Lithuania, Netherlands, Norway, Poland, Slovakia, Spain, Turkey, Australia, Canada, Chile, Hong Kong, India, Korea, Malaysia, Russia and Japan","Z-0511-2014","Class II","Stryker brand SUPER COMPLIANT 4MM X 7MM, Catalog Number: M003SSC04070; Product is manufactured by Stryker Neurovascular, Cork, Ireland and distributed by Stryker Neurovascular, Fremont, CA Excelsior SL-10/Excelsior 1018 Microcatheter: Stryker Neurovascular Microcatheters are intended to assist in the delivery of diagnostic agents, such as contrast media, and therapeutic agents, such as occlusion coils, into the peripheral, coronary, and neurovasculature. GDC 10, 18 Coils: The Gugliemi Detachable Coil is intended for the endovascular embolization of: (1) Intracranial aneurysms, (2) Other neurovascular abnormalities such as arteriovenous malformations and arteriovenous fistula, (3) Arterial and venous embolizations in the peripheral vasculature GDC 18-Fibered VortX Shape Coil: The GDC 18-Fibered VortX Shape Coil is intended for embolization of vascular abnormalities such as (1) Arteriovenous malformations and arteriovenous fistulae of the neurovasculature; (2) GDC 18- Fibered VoliX Shape Coil is also intended for arterial and venous embolizations in the peripheral vasculature. Transform: The Stryker Neurovascular TransForm Occlusion Balloon Catheters are indicated for use in the neurovasculature to temporarily stop or control blood flow and for balloon assisted embolization of aneurysms. ","17010792, 17010836, 17010880 ",".",,"Products were shipped labeled with ''use by'' dates that exceed currently available shelf-life data. All products remain within the earliest expiration date of April 2015.",11/4/2013,"11/04/2013",12/26/2013,"12/26/2013"
"Devices",66888,"Ongoing","Stryker Neurovascular","Fremont","CA","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution - USa (nationwide) and Internationally to: Austria, Belgium, Czech Rep, Germany, France, Great Britain, Hungary, Italy, Lithuania, Netherlands, Norway, Poland, Slovakia, Spain, Turkey, Australia, Canada, Chile, Hong Kong, India, Korea, Malaysia, Russia and Japan","Z-0508-2014","Class II","Stryker brand COMPLIANT 4MM X 30MM, Catalog Number: M003SRC04300; Product is manufactured by Stryker Neurovascular, Cork, Ireland and distributed by Stryker Neurovascular, Fremont, CA Excelsior SL-10/Excelsior 1018 Microcatheter: Stryker Neurovascular Microcatheters are intended to assist in the delivery of diagnostic agents, such as contrast media, and therapeutic agents, such as occlusion coils, into the peripheral, coronary, and neurovasculature. GDC 10, 18 Coils: The Gugliemi Detachable Coil is intended for the endovascular embolization of: (1) Intracranial aneurysms, (2) Other neurovascular abnormalities such as arteriovenous malformations and arteriovenous fistula, (3) Arterial and venous embolizations in the peripheral vasculature GDC 18-Fibered VortX Shape Coil: The GDC 18-Fibered VortX Shape Coil is intended for embolization of vascular abnormalities such as (1) Arteriovenous malformations and arteriovenous fistulae of the neurovasculature; (2) GDC 18- Fibered VoliX Shape Coil is also intended for arterial and venous embolizations in the peripheral vasculature. Transform: The Stryker Neurovascular TransForm Occlusion Balloon Catheters are indicated for use in the neurovasculature to temporarily stop or control blood flow and for balloon assisted embolization of aneurysms. ","17010705",".",,"Products were shipped labeled with ''use by'' dates that exceed currently available shelf-life data. All products remain within the earliest expiration date of April 2015.",11/4/2013,"11/04/2013",12/26/2013,"12/26/2013"
"Devices",66888,"Ongoing","Stryker Neurovascular","Fremont","CA","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution - USa (nationwide) and Internationally to: Austria, Belgium, Czech Rep, Germany, France, Great Britain, Hungary, Italy, Lithuania, Netherlands, Norway, Poland, Slovakia, Spain, Turkey, Australia, Canada, Chile, Hong Kong, India, Korea, Malaysia, Russia and Japan","Z-0498-2014","Class II","Stryker brand EXCELSIOR SL-10 150CM 2 TIP, Catalog Number: M0031681890, Product is manufactured by Stryker Neurovascular, Cork, Ireland and distributed by Stryker Neurovascular, Fremont, CA Excelsior SL-10/Excelsior 1018 Microcatheter: Stryker Neurovascular Microcatheters are intended to assist in the delivery of diagnostic agents, such as contrast media, and therapeutic agents, such as occlusion coils, into the peripheral, coronary, and neurovasculature. GDC 10, 18 Coils: The Gugliemi Detachable Coil is intended for the endovascular embolization of: (1) Intracranial aneurysms, (2) Other neurovascular abnormalities such as arteriovenous malformations and arteriovenous fistula, (3) Arterial and venous embolizations in the peripheral vasculature GDC 18-Fibered VortX Shape Coil: The GDC 18-Fibered VortX Shape Coil is intended for embolization of vascular abnormalities such as (1) Arteriovenous malformations and arteriovenous fistulae of the neurovasculature; (2) GDC 18- Fibered VoliX Shape Coil is also intended for arterial and venous embolizations in the peripheral vasculature. Transform: The Stryker Neurovascular TransForm Occlusion Balloon Catheters are indicated for use in the neurovasculature to temporarily stop or control blood flow and for balloon assisted embolization of aneurysms. ","17026534, 17026579, 17026624, 17026669, 17026714, 17026759, 17026804 ",".",,"Products were shipped labeled with ''use by'' dates that exceed currently available shelf-life data. All products remain within the earliest expiration date of April 2015.",11/4/2013,"11/04/2013",12/26/2013,"12/26/2013"
"Devices",66894,"Ongoing","Instrumentation Laboratory Co.","Bedford","MA","US","Voluntary: Firm Initiated","Letter","Nationwide Distribution","Z-0515-2014","Class II","HemosIL Low Abnormal Control 2 UNASSAYED Part Number: 0020003220","All lots",".","6504 kits","HemosIL Low, Abnormal, Normal Controls UNASSAYED (no-value assigned) lacks 510(k) approval",11/15/2013,"11/15/2013",12/26/2013,"12/26/2013"
"Devices",66894,"Ongoing","Instrumentation Laboratory Co.","Bedford","MA","US","Voluntary: Firm Initiated","Letter","Nationwide Distribution","Z-0516-2014","Class II","HemosIL High Abnormal Control 3 UNASSAYED Part Number: 0020003320","All lots",".","84561 kits","HemosIL Low, Abnormal, Normal Controls UNASSAYED (no-value assigned) lacks 510(k) approval",11/15/2013,"11/15/2013",12/26/2013,"12/26/2013"
"Devices",66894,"Ongoing","Instrumentation Laboratory Co.","Bedford","MA","US","Voluntary: Firm Initiated","Letter","Nationwide Distribution","Z-0514-2014","Class II","HemosIL Normal Control 1 UNASSAYED Part Number: 0020003120","All lots",".","80319 Kits","HemosIL Low, Abnormal, Normal Controls UNASSAYED (no-value assigned) lacks 510(k) approval",11/15/2013,"11/15/2013",12/26/2013,"12/26/2013"
"Devices",66896,"Ongoing","Sunrise Medical (US) LLC","Fresno","CA","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution-USA (nationwide) and the countries of Canada, Australia, Hong Kong, and China.","Z-0453-2014","Class II","Sunrise Brand Zippie Voyage, Chair with Casters, Early Intervention Device (Stroller), Model: EIZ14; Product is manufactured and distributed by Sunrise Medical (US) LLC., Fresno, CA. Used by a person to move from one place to another while sitting. ","Serial Numbers: ZV-001563 ,ZV-001672 ,ZV-001691 ,ZV-001737 ,ZV-001740 ,ZV-001423 ,ZV-001537 ,ZV-001557 ,ZV-001604 ,ZV-001746 ,ZV-001749 ,ZV-001761 ,ZV-001669 ,ZV-001682 ,ZV-001722 ,ZV-001755 ,ZV-001711 ,ZV-001415 ,ZV-001634 ,ZV-001716 ,ZV-001615 ,ZV-001521 ,ZV-001589 ,ZV-001617 ,ZV-001618 ,ZV-001627 ,ZV-001683 ,ZV-001702 ,ZV-001763 ,ZV-001773 ,ZV-001491 ,ZV-001531 ,ZV-001534 ,ZV-001562 ,ZV-001560 ,ZV-001569 ,ZV-001575 ,ZV-001720 ,ZV-001772 ,ZV-001635 ,ZV-001659 ,ZV-001777 ,ZV-001712 ,ZV-001487 ,ZV-001526 ,ZV-001574 ,ZV-001759 ,ZV-001595 ,ZV-001555 ,ZV-001603 ,ZV-001775 ,ZV-001520 ,ZV-001485 ,ZV-001519 ,ZV-001460 ,ZV-001687 ,ZV-001515 ,ZV-001614 ,ZV-001465 ,ZV-001742 ,ZV-001767 ,ZV-001685 ,ZV-001628 ,ZV-001785 ,ZV-001407 ,ZV-001408 ,ZV-001507 ,ZV-001658 ,ZV-001663 ,ZV-001511 ,ZV-001532 ,ZV-001545 ,ZV-001778 ,ZV-001568 ,ZV-001585 ,ZV-001607 ,ZV-001631 ,ZV-001629 ,ZV-001650 ,ZV-001654 ,ZV-001675 ,ZV-001717 ,ZV-001769 ,ZV-001430 ,ZV-001570 ,ZV-001559 ,ZV-001475 ,ZV-001488 ,ZV-001489 ,ZV-001490 ,ZV-001542 ,ZV-001578 ,ZV-001583 ,ZV-001656 ,ZV-001728 ,ZV-001714 ,ZV-001652 ,ZV-001653 ,ZV-001536 ,ZV-001676 ,ZV-001355 ,ZV-001366 ,ZV-001483 ,ZV-001594 ,ZV-001701 ,ZV-001709 ,ZV-001554 ,ZV-001735 ,ZV-001463 ,ZV-001638 ,ZV-001580 ,ZV-001695 ,ZV-001726 ,ZV-001443 ,ZV-001474 ,ZV-001486 ,ZV-001508 ,ZV-001598 ,ZV-001606 ,ZV-001608 ,ZV-001692 ,ZV-001696 ,ZV-001782 ,ZV-001619 ,ZV-001664 ,ZV-001424 ,ZV-001433 ,ZV-001451 ,ZV-001457 ,ZV-001493 ,ZV-001512 ,ZV-001516 ,ZV-001543 ,ZV-001564 ,ZV-001581 ,ZV-001590 ,ZV-001602 ,ZV-001613 ,ZV-001641 ,ZV-001667 ,ZV-001671 ,ZV-001668 ,ZV-001680 ,ZV-001679 ,ZV-001684 ,ZV-001751 ,ZV-001593 ,ZV-001756 ,ZV-001535 ,ZV-001470 ,ZV-001539 ,ZV-001565 ,ZV-001624 ,ZV-001662 ,ZV-001752 ,ZV-001753 ,ZV-001647 ,ZV-001670 ,ZV-001704 ,ZV-001747 ,ZV-001660 ,ZV-001681 ,ZV-001783 ,ZV-001431 ,ZV-001434 ,ZV-001447 ,ZV-001482 ,ZV-001524 ,ZV-001550 ",".","316 units in US, 29 units international","There is a remote possibility for the plastic latch to deform over the lifetime of use. When this happens there is the possibility for the seat to become dislodged from the base. And when not using the positioning strap, there is a risk that the occupant could slide out of the seat and sustain injury.",11/11/2013,"11/11/2013",12/11/2013,"12/11/2013"
"Food",66898,"Ongoing","Nexgen Pharma, Inc.","Colorado Springs","CO","US","Voluntary: Firm Initiated","Letter","Nationwide distribution. No foreign, military, govt, or VA consigees.","F-0382-2014","Class II","PCC, Rebecca's Natural Food, Sprouts Famous Market, Ritzman Pharmacy, Earth Fare, Hartig Drug, Viroqua Food, Ramona Fitness Center, Independent Choice (Health Trail Natural Foods-The Crunchy Grocer), Jimbo's, Outpost Natural Foods BRANDS- Woman's Once Daily Tablets - A dietary Supplement,Product Code Multivitamin/Mineral with Green Foods, Herbs, Enzymes & Probiotics Dietary Supplement. 90 Vegetarian Tablets. Manufactured for PCC Natural Markets Seattle, WA 98105","Lot No.: 416035",".","88","Nexgen Pharma Inc. is recalling one lot of Woman's Once Daily vitamin because it was contaminated with the antibiotic, Chloramphenicol.",11/19/2013,"11/19/2013",12/4/2013,"12/04/2013"
"Devices",66908,"Ongoing","Stryker Howmedica Osteonics Corp.","Mahwah","NJ","US","Voluntary: Firm Initiated","Letter","Nationwide Distribution","Z-0483-2014","Class II","Stryker Orthopaedics Cancellous Bone Screw Howmedica Osteonics Corp. 325 Corporate Drive Mahwah, NJ 07430 USA Stryker France ZAC Satolas Green Pusignan Av de Satolas Green 69881 Meyzieu Cedex France Both the 6.4 mm diameter, 25mm length, Cancellous Bone Screws (Cat no 2030-6525-1) and the 5.5mm diameter, 40 mm length Cancellous Bone Screws (Cat no 2029-5540-1) are cleared for use in Total Hip Arthroplasty (THA), when implanting Stryker's Hemispherical Cluster Hole Acetabular Shell Systems and Total Knee Arthroplasty (TKA) when implanting Stryker's Series 7000 Standard Tibial Tray systems. The use of bone screws, during both THA and TKA are intended as supplemental fixation.","510K # K894124 1) 6.5 mm Cancellous Bone Screw 25mm Catalog No: 2030-6525-1 Lot code MMLNLA 2) 5.5 Cancellous Bone Screw 40 mm Catalog No: 2029-5540-1 Lot Code MMLMJ1 ",,"Catalog Number 2030-6525-1- 4 units; Catalog No: 2029-5540-1-7 units","Stryker received a report from the field indicating that a 5.5 mm Cancellous Bone Screw 40 mm was identified in packaging associated with a 6.5 mm Cancellous Bone Screw 25 mm. ",10/1/2013,"10/01/2013",12/18/2013,"12/18/2013"
"Food",66911,"Ongoing","Pinnacle Foods, LLC","Parsippany","NJ","US","Voluntary: Firm Initiated","Telephone","NJ, NY, RI, CT, and MA","F-1104-2014","Class II","Aunt Jemima(R) HOMESTYLE FRENCH TOAST, 6 COUNT, NET WT. 12.5 OZ (354 g), UPC Code: 019600057703","Lot code: 4808084F11, Best by: August 8, 2014, UPC Code: 019600057703",".","153 cases of 12 units","This French Toast product contains bread (as an ingredient) that the supplier (Lewis Brothers Baking) is recalling because the bread has the potential for containing stainless steel fragments from a damaged dough mixer.",11/17/2013,"11/17/2013",12/26/2013,"12/26/2013"
"Devices",66918,"Ongoing","Intuitive Surgical, Inc.","Sunnyvale","CA","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution - USA (nationwide and Puerto Rico) and Internationally to Finland, Belgium, Netherlands, UK, Czech Republic, Sweden, Germany, Austria, Switzerland, Norway, Denmark, South Korea, France, Ireland, and Slovakia.","Z-0520-2014","Class II","Mega Needle Driver, 8MM assembly of the da Vinci S IS1200 and da Vinci Si, IS2000. Manufactured by Intuitive Surgical, Sunnyvale, CA. EndoWrist Instruments, including scissors, scalpels, forceps, needle drivers and electrocautery are intended for endoscopic manipulation of tissue, including: grasping, cutting, blunt and sharp dissection, approximation, ligation, electrocautery and suturing. Mega Needle Driver and Large Needle Driver instruments are part of the EndoWrist instrument family and are intended for use in endoscopic manipulation and suturing.","Part number 400194 on da Vinci IS1200; Lot numbers: 710191 M10110114 710197 M10110204 710261 M10110217 711061 M10110307 711121 M10110321 711191 M10110425 712071 M10110523 712171 M10110603 801041 M10110621 801151 M10110725 801171 M10110728 801301 M10110810 803171 M10110816 804121 M10110831 805091 M10110909 805271 M10110920 M10090320 S10080609 M10090512 S10080621 M10090709 S10080729 M10090731 S10080812 M10090812 S10080822 M10090824 S10080910 M10090909 S10080918 M10091020 S10081010 M10091110 S10081029 M10091130 S10081106 M10091211 S10081114 M10100114 S10081201 M10100216 S10081215 M10100218 S10090106 M10100428 S10090210 M10100526 S10090303 M10101026 S10090318 M10101103 S10090320 M10101125 S10090410 S10090715 S10110308. Part number 420194 - used on IS2000: lot numbers: 510071 M10090629 S10080802 710191 M10090706 S10080818 710261 M10090724 S10080822 711061 M10090727 S10080902 711121 M10090731 S10080910 711151 M10090810 S10080917 711191 M10090825 S10080926 712051 M10090828 S10080930 712131 M10090909 S10081002 712262 M10090916 S10081009 801021 M10091005 S10081014 801151 M10091008 S10081016 801181 M10091012 S10081029 801241 M10091030 S10081106 801301 M10091105 S10081114 802121 M10091123 S10081119 802201 M10091124 S10081202 802251 M10091130 S10081209 803121 M10091204 S10081218 803211 M10091211 S10081229 803261 M10091217 S10090106 804031 M10100105 S10090112 804111 M10100112 S10090114 804221 M10100114 S10090119 805121 M10100120 S10090121 805271 M10100122 S10090227 805301 M10100208 S10090302 M10090316 M10100216 S10090305 M10090324 S10080609 S10090312 M10090423 S10080618 S10090316 M10090505 S10080625 S10090318 M10090512 S10080708 S10090320 M10090528 S10080714 S10090327 M10090609 S10080723 S10090402 M10090624 S10080729 S10090406 M10100218 M10110112 M10110726 M10100224 M10110117 M10110802 M10100311 M10110131 M10110805 M10100318 M10110202 M10110809 M10100407 M10110208 M10110811 M10100412 M10110210 M10110817 M10100415 M10110218 M10110",".","15, 236 UPDATED 12/19/13 to 11,235","Firm has become aware of the potential for detachment of the jaw insert for Large Needle Drivers and Mega Needle Drivers.",11/15/2013,"11/15/2013",12/26/2013,"12/26/2013"
"Devices",66918,"Ongoing","Intuitive Surgical, Inc.","Sunnyvale","CA","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution - USA (nationwide and Puerto Rico) and Internationally to Finland, Belgium, Netherlands, UK, Czech Republic, Sweden, Germany, Austria, Switzerland, Norway, Denmark, South Korea, France, Ireland, and Slovakia.","Z-0521-2014","Class II","Large Needle Driver, 8MM assembly of the da Vinci S IS1200 and da Vinci Si, IS2000. Manufactured by Intuitive Surgical, Sunnyvale, CA. EndoWrist Instruments, including scissors, scalpels, forceps, needle drivers and electrocautery are intended for endoscopic manipulation of tissue, including: grasping, cutting, blunt and sharp dissection, approximation, ligation, electrocautery and suturing. Mega Needle Driver and Large Needle Driver instruments are part of the EndoWrist instrument family and are intended for use in endoscopic manipulation and suturing.","Part number 400006 on da Vinci IS1200; Lot numbers: 710182 801282 805131 M10080716 M10080910 M10090216 M10091104 M10100728 S10080613 710192 802042 805221 M10080718 M10081014 M10090225 M10091110 M10100729 S10080618 710262 802052 805271 M10080721 M10081024 M10090325 M10091113 M10100804 S10080624 710301 802061 910072 M10080722 M10081027 M10090325 M10091120 M10100810 S10080626 710302 802072 1610072 M10080723 M10081028 M10090401 M10091130 M10100813 S10080708 711052 802082 M10080603 M10080724 M10081029 M10090407 M10091209 M10100820 S10080709 711062 802122 M10080603 M10080725 M10081031 M10090415 M10091211 M10100902 S10080711 711072 802131 M10080603 M10080728 M10081104 M10090417 M10091214 M10100924 S10080712 711082 802152 M10080605 M10080729 M10081110 M10090427 M10091216 M10100927 S10080715 711092 802202 M10080606 M10080730 M10081111 M10090505 M10100113 M10100929 S10080718 711122 802212 M10080609 M10080731 M10081112 M10090514 M10100118 M10101026 711142 802252 M10080610 M10080801 M10081117 M10090519 M10100123 M10101103 711152 802262 M10080612 M10080804 M10081119 M10090521 M10100128 M10101118 711262 802272 M10080616 M10080805 M10081120 M10090526 M10100129 M10101123 711282 803042 M10080617 M10080806 M10081124 M10090604 M10100209 M10101124 711302 803101 M10080618 M10080807 M10081125 M10090605 M10100212 M10101209 712042 803112 M10080618 M10080808 M10081127 M10090616 M10100222 M10110113 712062 803132 M10080618 M10080811 M10081128 M10090704 M10100225 M10110131 712102 803172 M10080619 M10080812 M10081201 M10090713 M10100302 M10110208 712112 803192 M10080620 M10080813 M10081204 M10090717 M10100308 M10110210 712142 803212 M10080623 M10080814 M10081205 M10090728 M10100312 M10110217 712182 803241 M10080624 M10080815 M10081209 M10090810 M10100323 M10110224 712192 803261 M10080625 M10080818 M10081210 M10090811 M10100326 M10110304 712212 803271 M10080626 M10080819 M10081211 M10090817 M10100408 M10110310 801021 804081 M10080627 M10080820 M10081218 M10090826 M10100430 M10110317 801072 804101 M10080630 M10080821 M10090107 M10090901 M10",".","94, 981 UPDATED 12/19/13 to 56, 469","Firm has become aware of the potential for detachment of the jaw insert for Large Needle Drivers and Mega Needle Drivers.",11/15/2013,"11/15/2013",12/26/2013,"12/26/2013"
"Food",66920,"Ongoing","Jayone Foods, Inc.","Paramount","CA","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Nationwide in US","F-0823-2014","Class I","Trader Joe's Authentically Korean Seaweed Salad with Spicy Dressing, Net Wt. 3.5oz (99g), SKU 97677.","Lot Code: 04.24.2014 07.20.2014 10.02.2014 02.14.2015 03.13.2015 04.24.2015 05.12.2015 05.06.2015 06.25.2015 07.07.2015 07.31.2015 08.19.2015 ",,"349,872 units","Jayone Foods is recalling Trader Joe's Dried Seaweed Salad with Spicy Dressing because it may contain traces of undeclared peanuts. ",11/23/2013,"11/23/2013",12/18/2013,"12/18/2013"
"Drugs",66929,"Ongoing","Airgas Medical Services","Radnor","PA","US","Voluntary: Firm Initiated","Visit","Kansas, Missouri, and Arkansas.","D-366-2014","Class II","Carbon Dioxide, USP, Medical Gas, Rx only, Non Flammable Gas 2, in 50 lbs steel cylinders, Distributed by AIRGAS USA, LLC Radnor, PA","NDC 11054-002 Lot # TY00A260A Size G and H Part number 835148 ",".","264 cylinders","Labeling: Not Elsewhere Classified; Due to an error in the manufacturing procedure, a cylinder in liquid withdrawal service was not marked Syphon Tube indicating liquid withdrawal and shipped as a gas withdrawal cylinder.",11/6/2013,"11/06/2013",12/26/2013,"12/26/2013"
"Food",66932,"Ongoing","3 Fellers","Goochland","VA","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Products were distributed in Southern California, Virginia, Maryland, District of Columbia, Delaware, Pennsylvania, New Jersey, Ohio, and Kentucky.","F-1111-2014","Class I","Chocolate Cream Pie, 4.5 oz. package, 12 pks/case. UPC # 891796002732","Sell by dates: 10/29/2013 11/8/2013 12/13/2013 1/3/2014 2/19/2014 3/12/2014 3/17/2014 3/30/2014 4/24/2014 4/29/2014 5/6/2014 5/7/2014 ",".","3480 units","Chocolate pie contains almonds which are not declared on the label.",11/7/2013,"11/07/2013",12/26/2013,"12/26/2013"
"Devices",66944,"Ongoing","3M Company - Health Care Business","Saint Paul","MN","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution - USA (nationwide) and the countries of Canada, France, Germany, Hong Kong, Italy, Japan, Korea, Mexico, United Arab and Emirates.","Z-0535-2014","Class II","3M ESPE Imprint II Regular Body , Catalog Number 9379, and Paradigm Regular Body VPS, Catalog Number 5315, Impression Material that are intended to reproduce the structure of a patients teeth. Impression Materials are composed of hydrophilic vinyl polysiloxane impression materials, designed for making precise crown and bridge, inlay, onlay, veneer preparations, removable denture and partial denture impressions. ","Lot codes: N510884, N510889, and N511952",".","1977 kits","Specific lots of Imprint II and Paradigm impression material refill packs are being recalled because the moisture displacement feature in both is greatly reduced which may impact the quality of the dental impression.",11/21/2013,"11/21/2013",12/26/2013,"12/26/2013"
"Drugs",66945,"Ongoing","VistaPharm, Inc.","Largo","FL","US","Voluntary: Firm Initiated","Letter","Nationwide and Puerto Rico","D-342-2014","Class II","Phenytoin Oral Suspension USP 125mg/5mL, 50 cups per case, For Oral Administration Only, Rx Only, Manufactured by: VistaPharm Inc, Largo, FL 33771, NDC 66689-036-50","Lots #'s: 268200, Exp 06/14; 274600, Exp 08/14; 279500, Exp 09/14; 290700, Exp 12/14; 296700, Exp 02/15; 305100, Exp 06/15",,"27,788 cases","Defective Container: A lidding deformity allowed for the product to have out of specification results for assay and viscosity at the12 month stability timepoint.",10/15/2013,"10/15/2013",12/18/2013,"12/18/2013"
"Devices",66948,"Ongoing","Maquet Cardiovascular, LLC","Wayne","NJ","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution - USA (nationwide) and the countries of Brazil, Czech Republic, Denmark, France, Hong Kong, Italy, Middle East, Netherlands, Singapore, Switzerland, and the United Kingdom.","Z-0466-2014","Class II","Vasoview Hemopro Endoscopic Vessel Harvesting System Maquet Cardiovascular LLC 45 Barbour Pond Drive Wayne, NJ 07470 Indicated for use in minimally invasive surgery allowing access for vessel harvesting and is primarily indicated for patients undergoing endoscopic surgery for arterial bypass. It is indicated for cutting tissue and controlling bleeding through coagulation, and for patients requiring blunt dissection of tissue including dissection of blood vessels, dissection of blood vessels oft he extremities, dissection of ducts and other structures int he extraperitoneal or subcutaneous extremity and thoracic space. Extremity procedures include tissue dissection/vessel harvesting along the saphenous vein for use in coronary artery bypass grafting and peripheral artery bypass or the radial artery for use in coronary artery bypass grafting. Thorascopic procedures include exposure and dissection of structures external to the parietal pleura including nerves blood vessels and other tissues of the chest wall.","Catalog number VH-3000 (US) Lot numbers 25081686, 25081595, 25081460, 25081204, 25080939, 25080744, 25080418, 25080351, 25080264, 25079982, 25079913, 25073724, 25079449, 25079363, 25079086, 25078931, 25078713, 25078463, 25078291, 25078104, 25077927,25077643, 25077563, 25077123, 25076989, 25076372, 25076371, 25076133, Catalog number VH-3000W (Foreign) Lot numbers 25080938, 25080661, 25080311, 25078777, 25078289, 25078103 and 25077051",,"12,259 units","Maquet has received an increase in the number of complaints for ''self-activated/remains activated/overheats'' for the Hemopro VH-30000, ''Hemopro 1'' ",10/30/2013,"10/30/2013",12/18/2013,"12/18/2013"
"Food",66954,"Ongoing","Threshold Enterprises Ltd","Scotts Valley","CA","US","Voluntary: Firm Initiated","Letter","Nationwide distribution","F-1100-2014","Class II","Source Naturals Essential Enzyme Ultra VEGI-CAP: Premium Digestive Enzyme Blend; 30, 60, 90 & 120 count bottles. Vegetarian capsules Manufactured for: Source Naturals, Inc. Santa Cruz, CA","SN2329 Veg Cap 30 ct: Lot numbers FG-38147, FG-41401, Exp 4/20/2017; Lot numbers FG-31309, FG-35193 and FG-37071, Exp. 8/20/2016; UPC# 021078023296) Lot number FG-26565, Exp. 8/20/14. SN2330 Veg Cap 60 ct; Lot numbers FG-37072, FG-41218, Exp 4/20/2017; Lot numbers FG-26566, FG-31091, Exp 8/20/2016; Lot number FG-26566, Exp. 8/20/2014. SN2331 Veg Cap 90 ct; Lot number FG-37073, Exp 4/20/2017; Lot numbers FG-33524, FG-35564, Exp 8/20/2016; Lot number FG-26567, Exp 8/20/2014; SN2332 Veg Cap 120 ct: Lot numbers FG-37462, FG-40028, FG-41219, Exp. 4/20/2017; Lot numbers FG-34174, FG-35723, FG-36310, FG-39575, Exp 8/20/2016; Lot numbers FG-26568, FG-29388, Exp. 8/20/2014 SN7342 Veg Cap 30 + 30 ct. Lot number FG-37074, Exp. 8/20/2016.",".","12,352 bottles, all counts","Dietary Supplements were made with bulk products provided by National Enzyme Company which are currently under recall for chloramphenicol ",11/22/2013,"11/22/2013",12/26/2013,"12/26/2013"
"Food",66957,"Ongoing","Schwabe North America, Inc.","Green Bay","WI","US","Voluntary: Firm Initiated","Letter","US: AK, AL, AR, AZ, CA, CI, CT, DC, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, NS, NT, NC, ND, NE, NH, NJ, NM, NV, NY, H, OK, OR, PA, PR, RI,SC, SD, TN, TX, UT, VA, VT, WA, WI, WV, WY. OUS: South Korea, Ghana, Romania and Singapore.","F-0836-2014","Class II","Nature's Way,UPC 33674156797, Alive Once Daily MultiVitamin Ultra Potency, 60 Tabs, 20008123, 20010552","20008123, 20010552 ",".","17647","Nature's Way (NW) is voluntary recalling a number of products because the raw material supplier informed them that enzymes in the blend they provided to NW may contain the antibiotic chloramphenicol.",10/23/2013,"10/23/2013",12/26/2013,"12/26/2013"
"Food",66957,"Ongoing","Schwabe North America, Inc.","Green Bay","WI","US","Voluntary: Firm Initiated","Letter","US: AK, AL, AR, AZ, CA, CI, CT, DC, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, NS, NT, NC, ND, NE, NH, NJ, NM, NV, NY, H, OK, OR, PA, PR, RI,SC, SD, TN, TX, UT, VA, VT, WA, WI, WV, WY. OUS: South Korea, Ghana, Romania and Singapore.","F-0832-2014","Class II","Nature's Way,UPC 33674149324 Alive Whole Food Energizer ,180 Tabs, 20009819, 20012443","20009819, 20012443, 20013512",".","17259","Nature's Way (NW) is voluntary recalling a number of products because the raw material supplier informed them that enzymes in the blend they provided to NW may contain the antibiotic chloramphenicol.",10/23/2013,"10/23/2013",12/26/2013,"12/26/2013"
"Food",66957,"Ongoing","Schwabe North America, Inc.","Green Bay","WI","US","Voluntary: Firm Initiated","Letter","US: AK, AL, AR, AZ, CA, CI, CT, DC, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, NS, NT, NC, ND, NE, NH, NJ, NM, NV, NY, H, OK, OR, PA, PR, RI,SC, SD, TN, TX, UT, VA, VT, WA, WI, WV, WY. OUS: South Korea, Ghana, Romania and Singapore.","F-0835-2014","Class II","Nature's Way,UPC 33674155424, Alive Whole Food Energizer Men's, 90 Tabs, 20010871","20010871",".","624","Nature's Way (NW) is voluntary recalling a number of products because the raw material supplier informed them that enzymes in the blend they provided to NW may contain the antibiotic chloramphenicol.",10/23/2013,"10/23/2013",12/26/2013,"12/26/2013"
"Food",66957,"Ongoing","Schwabe North America, Inc.","Green Bay","WI","US","Voluntary: Firm Initiated","Letter","US: AK, AL, AR, AZ, CA, CI, CT, DC, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, NS, NT, NC, ND, NE, NH, NJ, NM, NV, NY, H, OK, OR, PA, PR, RI,SC, SD, TN, TX, UT, VA, VT, WA, WI, WV, WY. OUS: South Korea, Ghana, Romania and Singapore.","F-0840-2014","Class II","NL C 24/7 Bulk Caps ","20012546 20012547 ",".","2455.770","Nature's Way (NW) is voluntary recalling a number of products because the raw material supplier informed them that enzymes in the blend they provided to NW may contain the antibiotic chloramphenicol.",10/23/2013,"10/23/2013",12/26/2013,"12/26/2013"
"Food",66957,"Ongoing","Schwabe North America, Inc.","Green Bay","WI","US","Voluntary: Firm Initiated","Letter","US: AK, AL, AR, AZ, CA, CI, CT, DC, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, NS, NT, NC, ND, NE, NH, NJ, NM, NV, NY, H, OK, OR, PA, PR, RI,SC, SD, TN, TX, UT, VA, VT, WA, WI, WV, WY. OUS: South Korea, Ghana, Romania and Singapore.","F-0841-2014","Class II","Complete Phyto-Energizer Bulk vcaps ","20010007 ",".","1048.53","Nature's Way (NW) is voluntary recalling a number of products because the raw material supplier informed them that enzymes in the blend they provided to NW may contain the antibiotic chloramphenicol.",10/23/2013,"10/23/2013",12/26/2013,"12/26/2013"
"Food",66957,"Ongoing","Schwabe North America, Inc.","Green Bay","WI","US","Voluntary: Firm Initiated","Letter","US: AK, AL, AR, AZ, CA, CI, CT, DC, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, NS, NT, NC, ND, NE, NH, NJ, NM, NV, NY, H, OK, OR, PA, PR, RI,SC, SD, TN, TX, UT, VA, VT, WA, WI, WV, WY. OUS: South Korea, Ghana, Romania and Singapore.","F-0833-2014","Class II","Nature's Way,UPC 33674150900, Alive Whole Food Energizer MultiVitamin 90 Vcaps, 20009817","20009817",".","1500","Nature's Way (NW) is voluntary recalling a number of products because the raw material supplier informed them that enzymes in the blend they provided to NW may contain the antibiotic chloramphenicol.",10/23/2013,"10/23/2013",12/26/2013,"12/26/2013"
"Food",66957,"Ongoing","Schwabe North America, Inc.","Green Bay","WI","US","Voluntary: Firm Initiated","Letter","US: AK, AL, AR, AZ, CA, CI, CT, DC, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, NS, NT, NC, ND, NE, NH, NJ, NM, NV, NY, H, OK, OR, PA, PR, RI,SC, SD, TN, TX, UT, VA, VT, WA, WI, WV, WY. OUS: South Korea, Ghana, Romania and Singapore.","F-0838-2014","Class II","Nature's Way,UPC 33674156865, Alive Once Daily Women's Ultra Potency, 60 Tabs, 20010554, 20011595, 20014135","20010554, 20011595, 20014135",".","23156","Nature's Way (NW) is voluntary recalling a number of products because the raw material supplier informed them that enzymes in the blend they provided to NW may contain the antibiotic chloramphenicol.",10/23/2013,"10/23/2013",12/26/2013,"12/26/2013"
"Food",66957,"Ongoing","Schwabe North America, Inc.","Green Bay","WI","US","Voluntary: Firm Initiated","Letter","US: AK, AL, AR, AZ, CA, CI, CT, DC, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, NS, NT, NC, ND, NE, NH, NJ, NM, NV, NY, H, OK, OR, PA, PR, RI,SC, SD, TN, TX, UT, VA, VT, WA, WI, WV, WY. OUS: South Korea, Ghana, Romania and Singapore.","F-0837-2014","Class II","Nature's Way,UPC 33674156858, Alive Once Daily Men's Ultra Potency, 60 Tabs, 20010553, 20012800","20010553, 20012800",".","12258","Nature's Way (NW) is voluntary recalling a number of products because the raw material supplier informed them that enzymes in the blend they provided to NW may contain the antibiotic chloramphenicol.",10/23/2013,"10/23/2013",12/26/2013,"12/26/2013"
"Food",66957,"Ongoing","Schwabe North America, Inc.","Green Bay","WI","US","Voluntary: Firm Initiated","Letter","US: AK, AL, AR, AZ, CA, CI, CT, DC, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, NS, NT, NC, ND, NE, NH, NJ, NM, NV, NY, H, OK, OR, PA, PR, RI,SC, SD, TN, TX, UT, VA, VT, WA, WI, WV, WY. OUS: South Korea, Ghana, Romania and Singapore.","F-0831-2014","Class II","Nature's Way, UPC 33674149263, Alive Whole Food Energizer with Iron, 60 Tabs 20009807; Nature's Way, UPC 33674149270, Alive Whole Food Energizer with Iron, 90 Tabs 20009808. 33674149287 Alive Whole Food Energizer with Iron, 180 Tabs 20012063","20009807, 20009808, 20012063",".","7113","Nature's Way (NW) is voluntary recalling a number of products because the raw material supplier informed them that enzymes in the blend they provided to NW may contain the antibiotic chloramphenicol.",10/23/2013,"10/23/2013",12/26/2013,"12/26/2013"
"Food",66957,"Ongoing","Schwabe North America, Inc.","Green Bay","WI","US","Voluntary: Firm Initiated","Letter","US: AK, AL, AR, AZ, CA, CI, CT, DC, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, NS, NT, NC, ND, NE, NH, NJ, NM, NV, NY, H, OK, OR, PA, PR, RI,SC, SD, TN, TX, UT, VA, VT, WA, WI, WV, WY. OUS: South Korea, Ghana, Romania and Singapore.","F-0834-2014","Class II","Nature's Way,UPC 33674150924, Alive Whole Food Energizer MultiVitamin ( No Iron Added), 90 Vcaps, 20009818","20009818",".","5191","Nature's Way (NW) is voluntary recalling a number of products because the raw material supplier informed them that enzymes in the blend they provided to NW may contain the antibiotic chloramphenicol.",10/23/2013,"10/23/2013",12/26/2013,"12/26/2013"
"Food",66957,"Ongoing","Schwabe North America, Inc.","Green Bay","WI","US","Voluntary: Firm Initiated","Letter","US: AK, AL, AR, AZ, CA, CI, CT, DC, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, NS, NT, NC, ND, NE, NH, NJ, NM, NV, NY, H, OK, OR, PA, PR, RI,SC, SD, TN, TX, UT, VA, VT, WA, WI, WV, WY. OUS: South Korea, Ghana, Romania and Singapore.","F-0839-2014","Class II","Nature's Way, UPC 33674156926, Alive Once Daily Women's 50+, 60 Tabs, 20007818, 20011423."," 20007818, 20011423",".","39430","Nature's Way (NW) is voluntary recalling a number of products because the raw material supplier informed them that enzymes in the blend they provided to NW may contain the antibiotic chloramphenicol.",10/23/2013,"10/23/2013",12/26/2013,"12/26/2013"
"Food",66957,"Ongoing","Schwabe North America, Inc.","Green Bay","WI","US","Voluntary: Firm Initiated","Letter","US: AK, AL, AR, AZ, CA, CI, CT, DC, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, NS, NT, NC, ND, NE, NH, NJ, NM, NV, NY, H, OK, OR, PA, PR, RI,SC, SD, TN, TX, UT, VA, VT, WA, WI, WV, WY. OUS: South Korea, Ghana, Romania and Singapore.","F-0843-2014","Class II","Alive No Iron (for international sales), 30 Tabs HDPE Bottle in a Box 12 ","20012624",".","12000","Nature's Way (NW) is voluntary recalling a number of products because the raw material supplier informed them that enzymes in the blend they provided to NW may contain the antibiotic chloramphenicol.",10/23/2013,"10/23/2013",12/26/2013,"12/26/2013"
"Food",66957,"Ongoing","Schwabe North America, Inc.","Green Bay","WI","US","Voluntary: Firm Initiated","Letter","US: AK, AL, AR, AZ, CA, CI, CT, DC, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, NS, NT, NC, ND, NE, NH, NJ, NM, NV, NY, H, OK, OR, PA, PR, RI,SC, SD, TN, TX, UT, VA, VT, WA, WI, WV, WY. OUS: South Korea, Ghana, Romania and Singapore.","F-0842-2014","Class II","GL Completia, 90 vcaps HDPE Bottle in a Box 12 ","20009982",".","4666","Nature's Way (NW) is voluntary recalling a number of products because the raw material supplier informed them that enzymes in the blend they provided to NW may contain the antibiotic chloramphenicol.",10/23/2013,"10/23/2013",12/26/2013,"12/26/2013"
"Food",66959,"Ongoing","Flora Inc","Lynden","WA","US","Voluntary: Firm Initiated","Letter","Distributed in the following states: FL, GA, IL, IN, KY, MD, MI, NC, NJ, NV, NY, OH, PA, and SC.","F-1110-2014","Class II","Flora Double Ginger Herbal Tea Blend, 16/1.24 oz (35.2g) tea bags per package. UPC 0 61998 63757 9 The product is labeled in parts: ''***DOUBLE GINGER HERBAL TEA BLEND***FLORA***CERTIFIED ORGANIC***FRESH-SEALED TEA BAGS***16***NET WT 1.24 oz***(35.2 g)***INGREDIENTS: GINGER ROOT, LEMONGRASS HERB, PEPPERMINT LEAVES, LICORICE ROOT, BLACK PEPPER SEEDS, *ORGANIC***IMPORTED BY: FLORA INC., 805 E. BADGER RD. LYNDEN, WA***''.","BB/MA: 2019-09, LOT: 13268 10314 19R8F 268:17:49 Give a breakdown of the code: BB/MA = Best before date 2016-09; LOT 1326810314; 19RF = Organic number 268:17:49 = Manufacturing date and time",".","6024 boxes (16 tea bags per box)","Flora Double Ginger Herbal Tea Blend 1.24 oz was recalled due to contamination with Salmonella.",11/18/2013,"11/18/2013",12/26/2013,"12/26/2013"
"Devices",66963,"Ongoing","Roche Diagnostics Operations, Inc.","Indianapolis","IN","US","Voluntary: Firm Initiated","Letter","US Distribution including the states of AL, AZ, CA, CT, GA, NY, NC, NJ, OH, TX, VA and WA.","Z-0536-2014","Class II","MagNA Pure 96 System Version 1.0 Software Version 2.0 Robotic workstation for automated isolation of nucleic acids from different kinds of crude sample material (whole blood, serum, blood cells, culture cells, tissue, bacteria, fungi) by the use of the specially designed MagNA Pure reagent kits, automated filling of different kinds of PCR reaction vessels.","Serial Numbers 2001, 2002, 2003, 2004, 2006, 2011, 2012, 2013, 2014, 2015, 2016, 2018, 2019, 2020, 2021, 2022, 2023, 2024, 2025, 2026, 2027, 2028, 4001, 4022, 4023, 4024, 4025, ",".","27","This issue is only relevant for customers importing xml files into the MagNA Pure 96 IVD instrument software for sample identification. There is a potential for sample mismatch when using the MagNA Pure 96 IVD instrument (catalog number 06541089001). Importing an order file in xml format to the MagNA Pure 96 IVD instrument software may result in a wrong sequence of samples in the graphical overview of the Pipetting Report (generated right after import of the xml file). If this issue has occurred, the corresponding Purification Report shows samples in a transposed order. However, the assigned sample information in the Purification Report (e.g., sample numbering, sample names, notes, position, and status) is correct; only the indicated sequence is wrong. This issue is not reproducible and only occurs randomly. To avoid a potential sample mismatch, discontinue use of the Pipetting Report to identify samples when manually pipetting samples after extraction. MagNA Pure processes that generate a sample list xml file for downstream applications are not affected as they do not use the Pipetting Report. The MagNA Pure 96 Instrument Operators Guide is being updated with an addendum addressing this issue.",11/25/2013,"11/25/2013",12/26/2013,"12/26/2013"
"Devices",66964,"Ongoing","Biomet, Inc.","Warsaw","IN","US","Voluntary: Firm Initiated","Letter","hospitals MI, IA, IL, IN, TN","Z-0523-2014","Class II","outer box: Ref 906768, CurvTek Eye Needle 22 MM X-large Stainless Steel, Single Use Gamma Sterilized, Rx inner incorrect label: CurvTek 7 MM Medium, Single Pack Quantity -3, REF 906760 To pass the CurvTek needle, place the jaws of the instrument utilized to grasp the needle on the sides of the needle and orient and needle parallel to the long axis of the instrument. Position the needle to follow the path of the tunnel created by the cartridges. This aligns the needle with the radius of the transosseous tunnel. Advance the needle while rotating the instrument away from the entry point. Gently feed the needle through the length of the tunnel.","Lot 055450",".","21","Inner label of PN: 906768 Lot: 055450 CurvTek Eye Needle 22mm X-Large states incorrectly PN: 906760 7mm Medium. ",11/26/2013,"11/26/2013",12/26/2013,"12/26/2013"
"Devices",66967,"Ongoing","Biomet, Inc.","Warsaw","IN","US","Voluntary: Firm Initiated","E-Mail","All product in USA is under Biomet control; Europe, Italy, UK, Australia, Japan","Z-0493-2014","Class II","G7 Acetabular Screw 6.5mmx35mm Part Number: 010001000 ","Lot Numbers: 3070517, 3070528, 3077748, 3077750, 3077751, 3085183, 3105038, 3123395, 3123398, 3123399, 3123400, 3146439, 3165497, 3165498, 3165499, 3165500, 3181736",".","532 in USA all under Biomet USA control","Investigation identified that the outer label, inner label, and patient label all have the incorrect diameter size of 10.5mm. The screw is actually a 6.5mm diameter and correctly corresponds to the items number on the label.",11/26/2013,"11/26/2013",12/26/2013,"12/26/2013"
"Devices",66970,"Ongoing","GE Healthcare, LLC","Waukesha","WI","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution - USA (nationwide) to CA, CT, FL, GA, MO, NC, NJ, PA, TX, WI and Internationally to: FRANCE, PORTUGAL, ALGERIA, ANGOLA, ARGENTINA, AUSTRALIA, AUSTRIA, AZERBAIJAN, BAHRAIN, BANGLADESH, BARBADOS, BELGIUM, BOLIVIA, BOSNIA 7 HERZEGOVINA, BRAZIL, BRUNEI DARUSSALAM, BULGARIA, NEW ZEALAND, CHILE, CHINA, COLOMBIA, CONGO, COSTA RICA, COTE DLVOIRE, CROATIA, CYPRUS,. CZECH REPUBLIC, DENMARK, DOMINICAN REPUBLIC, ECUADOR, EGYPT, EL SALVADOR, ESTONIA, FINLAND, GABON, GERMANY, GREECE, GUATEMALA, HONDURAS, HUNGARIA, INDIA, INDONESIA, IRAQ, IRELAND, ISRAEL, ITALY, JAMAICA, KENYA, REPUBLIC OF KOREA, KUWAIT, LATVIA, LEBANON, LITHUANIA, MALAYSIA, MEXICO, MOLDOVA, MOROCCO, MYAMMARA, NAMBIA, NAPAL, NETHERLANDS, NICARAGUA, NIGERIA, NORWAY, OMAN, PAKISTAN, PANAMA, PARAGUAY, PHILIPPINES, POLAND, PORTUGAL ROMANIA, RUSSIA, SENEGAL SINGAPORE, SLOVAKIA, SLOVENIA, SOUTH AFRICA, SPAIN, SIR LANKA, SWEDEN, SWITZERLAND, THAILAND, THE NETHERLANDS, TRINIDAD AND TOBAGO, TUNISIA, TURKEY, UNITED ARAB EMIRATES , UNITED KINGDOM, URUGUAY, UZEBEKISTAN, VENEZUELA, and VIETNAM.","Z-0489-2014","Class II","HGE Healthcare Patient Monitor B30, Procare Monitor B20, Procare Monitor B40, and Monitor B40 K122253 (Procare Monitor B20): The PROCARE Monitor B20 is a portable multiparameter unit to be used for monitoring and recording of, and to generate alarms for, multiple physiological parameters of adult, pediatric, and neonatal patients in a hospital environment and during intra-hospital transport. The PROCARE Monitor B20 is intended for use under the direct supervision of a licensed health care practitioner. The PROCARE Monitor B20 is not intended for use during MRI. The PROCARE Monitor B20 monitors and displays oscillometric non-invasive blood pressure (systolic, diastolic and mean arterial pressure), invasive blood pressure, end-tidal carbon dioxide, heart/pulse rate, respiration rate, EGG (including arrhythmia and ST segment analysis), temperature with a reusable or disposable electronic thermometer for continual monitoring. Esosophageal/Nasopharyngeal/Tymnpanic/Rectal/Bladder/Axillary/Skin/Airway/Room/Myo cardial/Core/Surface temperature, and functional oxygen saturation (Sp0 2) and pulse rate via continuous monitoring , including monitoring during conditions of clinical patient motion or low perfusion. K120598 (Procare Monitor B40): The PROCARE Monitor 840 is a portable multiparameter unit to be used for monitoring and recording of, and to generate alarms for, multiple physiological parameters of adult, pediatric, and neonatal patients in a hospital environment and during intra-hospital transport. The PROCARE Monitor 840 is intended for use under the direct supervision of a licensed health care practitioner. The PROCARE Monitor 840 is not intended for use during MRI. The PROCARE Monitor B40 monitors and displays oscillometric non-invasive blood pressure (systolic, diastolic and mean arterial pressure), invasive blood pressure, end-tidal carbon dioxide, heart/pulse rate, respiration rate, ECG (including arrhythmia and ST segment analysis), temperature with a reusable or disposable electronic thermometer for cont","Mfg Lot or Serial # SG212501463WA SG213142063WA SG212491284WA SG212491286WA SG212491320WA SG212491328WA SG213091890WA SG213142034WA SG213142065WA SG213172123WA SG213172126WA SG213172141WA SF311283756WA SF312205556WA SG212190622WA SG212190623WA SG212190624WA SG212190625WA SG212190626WA SG212190627WA SG212190628WA SG212190629WA SG212190630WA SG212190631WA SG212160603WA SG212160606WA SG212230660WA SG212260716WA SG212260735WA SG212260737WA SG212260739WA SG212270742WA SG212270747WA SG212491329WA SG212491346WA SG212421031WA SG212431128WA SG212421034WA SG213021574WA SG213031688WA SG212521557WA SG212521545WA SF312396183WA SF312396187WA SF312396189WA SF312396190WA SF312396191WA SF312396192WA SF312396193WA SG213142038WA SG212521547WA SG213021582WA SG213021585WA SG213031681WA SG213031683WA SG213031684WA SG213031685WA SG213031687WA SG213031689WA SF310200786WA SF310200788WA SG212521544WA SG212521546WA SG212521548WA SG212521549WA SG212521550WA SG212521551WA SG212521552WA SG212521553WA SG212521554WA SG212521555WA SG212521556WA SG212521558WA SG212521559WA SG212521560WA SG212521561WA SG212521563WA SG212521564WA SG212521565WA SG213021570WA SG213021571WA SG213021572WA SG213021573WA SG213021575WA SG213021576WA SG213021577WA SG213021579WA SG213021580WA SG213021581WA SG213021583WA SG213021584WA SG213021612WA SG213021614WA SG213021615WA SG213021617WA SG213021618WA SG213021619WA SG213021620WA SG213021621WA SG213021622WA SG213021626WA SG213021627WA SG213021630WA SG213031631WA SG213031632WA SG213031634WA SG213041690WA SG213041691WA SG213041692WA SG213041709WA SG213041712WA SG213041714WA SG213041715WA SG213041723WA SG213041724WA SG213041725WA SG213041726WA SG213041727WA SG213041728WA SG213041729WA SG213041730WA SG213041731WA SG213041732WA SG213041733WA SG213041734WA SG213101906WA SG213132003WA SG213132015WA SG213142039WA SG213142040WA SG213142041WA SG213142042WA SG213142044WA SG213142045WA SG213142046WA SG213142049WA SG213142051WA SG213142055WA SG213142057WA SG213142058WA SG213142060WA SG213142064WA SG213142066WA SG213142067WA SG2131420"," SGF11510660WA SGF11510664WA SGF11510668WA SGF11510669WA SGF11510670WA SGF11510673WA SGF11510674WA SGF11510676WA SGF11510683WA SGF11510684WA SGF11510686WA SGF11510687WA SGF11510695WA SGF11510697WA SGF11510698WA SGF11510699WA SGF11510700WA SGF11510701WA SGF11510702WA SGF11510703WA SGF11510706WA SGF11510707WA SGF11510708WA SGF11510709WA SGF11510710WA SGF11510711WA SGF11510712WA SGF11510713WA SGF11510714WA SGF11510715WA SGF11510717WA SGF11510718WA SGF11510720WA SGF11510724WA SGF11510725WA SGF11510726WA SGF11510727WA SGF11510728WA SGF11510739WA SGF11510740WA SGF11510741WA SGF11510742WA SGF12253022WA SGF12253024WA SGF12253025WA SGF12253026WA SGF12253071WA SGF12253074WA SGF12253076WA SGF12253077WA SGF12253078WA SGF12253080WA SGF12253083WA SGF12253085WA SGF12253089WA SGF12253091WA SGF12253092WA SGF12253093WA SGF12253102WA SGF12253104WA SGF12253105WA SGF12253106WA SGF12253107WA SGF12253108WA SGF12253109WA SGF12253111WA SGF12253112WA SGF12253114WA SGF12253115WA SGF12253117WA SGF12253120WA SGF12253121WA SGF12253125WA SGF12253126WA SGF12253127WA SGF12263133WA SGF12263134WA SGF12263135WA SGF12263136WA SGF12263137WA SGF12263141WA SGF12263142WA SGF12263166WA SGF12263167WA SGF12263168WA SGF12263218WA SGF12263219WA SGF12263220WA SGF12263221WA SGF12263222WA SGF12263223WA SGF12263224WA SF312065028WA SGF11510672WA SGF11510675WA SGF11510685WA SGF11510696WA SGF11450343WA SGF11450344WA SGF11450346WA SGF11490497WA SGF11490498WA SGF11490499WA SGF11490500WA SGF11490501WA SGF11490503WA SGF11490505WA SGF11490506WA SGF11500547WA SGF11500548WA SGF11500558WA SGF11500559WA SGF11500560WA SGF11500561WA SGF11500571WA SGF11500572WA SGF11500573WA SGF11500574WA SGF11500578WA SGF11500579WA SGF11500583WA SGF11500584WA SGF11500585WA SGF11500586WA SGF11500587WA SGF11500588WA SGF11500589WA SGF11500590WA SGF11500591WA SGF11500592WA SGF11500593WA SGF11500594WA SGF11500595WA SGF11510744WA SGF11510745WA SGF11510746WA SGF11510748WA SGF11510751WA SGF11510752WA SGF11510753WA SGF11510754WA SGF11510755WA SGF11510759WA SGF11510760WA SGF11510761WA SGF12373754WA ","16,061 (343 US, 15,718 OUS)","GE Healthcare has recently become aware of a potential safety issue due to ECG filter settings associated with the B20/B40 V1, B30 and B40 V2 Patient Monitors. The B20, B30 and B40 Patient Monitors set the ECG filter setting incorrectly if the monitor starts with impedance respiration set in the ON position. Instead of the user selected filter, an additional 0.5 Hz high pass filter is used. The additional 0.5 Hz high pass filter causes changes to the ECG waveform morphology and incorrect display of ST values. The ST-elevation measurement can be under estimated in this situation and therefore the treatment of the patient can be delayed.",10/11/2013,"10/11/2013",12/18/2013,"12/18/2013"
"Biologics",66975,"Ongoing","SCC Soft Computer","Clearwater","FL","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Nautionwide; Puerto Rico and CANADA","B-0216-14","Class II","SoftBank II versions: 23.1, 23.2, 25.0, 25.1, 25.2, and 25.3. When used with SoftScape GUI 1.2.0.x and 1.3.0.x","SoftBank II version 23.1; 23.2; 25.0; 25.1; 25.2 and 25.3. When used with SoftScape GUI 1.2.0.x and 1.3.0.x ",,"6","Blood Bank software with a defect or glitch, was distributed. ",11/11/2013,"11/11/2013",12/18/2013,"12/18/2013"
"Devices",66978,"Ongoing","Ultradent Products, Inc.","South Jordan","UT","US","Voluntary: Firm Initiated","Letter","Nationwide Distribution including UT, CA, WA, VA, OH, and TN.","Z-0481-2014","Class III","Opal Orthodontics by Ultradent. Avex CX2 Ceramic Orthodontic Brackets Avex CX2 ceramic brackets are intended for use in orthodontic treatment.","R&D Lot Numbers:4519 - 4522, 4524 - 4527, 4530 - 4534, 4537 - 4548, 4550 - 4554, 4558 - 4612, 4618 - 4624",,"217 units","Ultradent Products Inc. is recalling various lots of Avex CX2 Orthodontic Brackets because the design control process was not complete prior to distribution.",11/19/2013,"11/19/2013",12/18/2013,"12/18/2013"
"Devices",66983,"Ongoing","ASI Medical, Inc.","Centennial","CO","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution - USA (nationwide) including the countries of Austria, Aruba, Saudi Arabia, Canada, Germany, Spain and West Indies.","Z-0545-2014","Class II","SEAC Advanced Dental System, Model A591561 The SEAC Advanced Dental System is a self-contained dental delivery system with a built-in air compressor,vacuum system and water supply. It is designed operate dental handpiece attachments and suction instruments. The SEAC Advanced Dental System can also be upgraded to include a Micadent air abrasion system mounted inside the unit with the handpiece mounted in a holder along side the other handpiece connections. The Micadent is used to perform intra oral air abrasion procedures including etching and preparing surfaces for composite restoration. The SEAC Advanced Dental System is substantially similar in design and functions as the SEAC Mobile Dental System manufactured by ASI Medical, Inc. The Micadent is manufactured by Medidents and will be supplied to ASIas a completed product. The Micadent is substantially the same as it is provided and is attached to an accessory air line inside the SEAC unit for operation. It is intended for use to provide general dental restorative care and hygiene procedures in both traditional dental office settings and/or mobile applications by or under the supervision of a licensed dentist or a hygienist if permitted by applicable law. ","Code No: 2010, 2020,2120 and 2220 Serial No: 590341- 592066 ",".","333","ASI Medical is initiating a field correction for the SEAC Advanced Dental System because the miniature plastic air tank can potentially rupture.",11/5/2013,"11/05/2013",12/26/2013,"12/26/2013"
"Food",66984,"Ongoing","Huxtable's Kitchen Inc","Vernon","CA","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Trader Joe's stores in Southern California, Utah, Southern Nevada and Texas.","F-0827-2014","Class I","Trader Joe's Butternut Squash & Creamed Spinach Gratin, 16 oz.","SKU 96541. USE BY 12/13/13. LOT 235211.",".","3,270 units","One specific lot of Trader Joe's Butternut Squash & Creamed Spinach Gratin due to undeclared wheat and egg.",12/2/2013,"12/02/2013",12/26/2013,"12/26/2013"
"Devices",66987,"Ongoing","Smiths Medical ASD, Inc.","Saint Paul","MN","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution - USA (nationwide ) including the states of : AZ, NY, TN, MS, AR, WV, VA, VT, PA, DE, DC, OH, CO, NH, MI, CA, FL, CT, WA, MD, NM, RI, MA, TX, NC, IL, KY, WI and MI., and the countries of CANADA, SAUDI ARABIA and AUSTRALIA.","Z-0540-2014","Class II","Medfusion 4000 Syringe Infusion Pumps Medfusion 4000 Syringe Infusion Pumps are designed for use in care areas for the administration of fluids requiring precisely controlled infusion rates. These pumps are indicated for use by healthcare professionals in the delivery of IV solutions, drug solutions, blood or blood products, and enteral feedings in continuous, intermittent, and body weight delivery modes.","All Medfusion 4000 Syringe Pumps in the field are affected by this Field Safety Corrective Action.",".","9546 (8587 US, 959 OUS)","Smiths Medical is conducting a recall involving all Medfusion 4000 Syringe Infusion Pumps. Smiths Medical has identified an issue with electrical shorting at the AC power receptacle. Shorting can occur when saline solution or other conductive fluids (e.g., potassium chloride) enter the AC power receptacle. When this happens, sparking and/ or flames, accompanied by smoke, may appear at the AC power receptacle. The pump and the AC power cord are constructed of flame retardant materials; therefore, the sparks/ flames extinguish within seconds. Smiths Medical has received no reports of injury or any damage beyond damage to the pump and AC power cord associated with this issue. If this issue occurs there is a potential for a delay in therapy while a replacement or alternative method of delivery is obtained.",11/22/2013,"11/22/2013",12/26/2013,"12/26/2013"
"Devices",66989,"Ongoing","Baxter Corporation Englewood","Englewood","CO","US","Voluntary: Firm Initiated","Letter","Nationwide Distribution","Z-0539-2014","Class II","ABACUS TPN Calculation Software, Baxa: 8300-0045 ABACUS CE (Calculator Edition), 8300-0046 ABACUS SE (Single-Workstation Edition), 8300-0047 ABACUS ME (Multi-Workstation Edition) ABACUS is a Windows - based order entry TPN software application for comprehensive calculations and label printing. The primary use of Abacus is for TPN order calculations. Other uses of Abacus include: non-TPN volumes administered to patients on TPN therapy in order calculations; CVVH calculations; Cardioplegia (Buckburg) calculations; Epidural calculations; Dilutions from concentrated ingredient; Combinations of multiple ingredients; Fractional doses from larger volumes","Product Code: 8300-0045,,8300-0046,,8300-0047,,8300-0045,,8300-0046,,8300-0047,,8300-0045,,8300-0046,,8300-0047,,8300-0045,,8300-0046,,8300-0047,,8300-0045,,8300-0046,,8300-0047",".","2,211","Baxter Healthcare Corporation is issuing a voluntary correction for ABACUS Total parenteral Nutrition (TPN) Calculation Software versions 2.0 through 3.0 due to the possibility that a patient could receive another patient's TPN order as a result of data corruption.",12/3/2013,"12/03/2013",12/26/2013,"12/26/2013"
"Devices",66992,"Ongoing","GE OEC Medical Systems, Inc","Salt Lake City","UT","US","Voluntary: Firm Initiated","Letter","Nationwide Distribution","Z-0524-2014","Class II","InstaTrak 3500 Plus, ENTrakTM Plus, InstaTrak 3500, ENTrakTM Computer-Assisted Navigation Systems (USA), ","Model Numbers IT2500,IT2500 Plus,IT3500, IT3500 Plus",".","654","GE OEC Medical Systems Inc is recalling InstaTrak 3500 Plus, ENTrakTM Plus, InstaTrak 3500, ENTrakTM Computer-Assisted Navigation Systems (USA) due to several potential safety issues related to the use of these products.",11/26/2013,"11/26/2013",12/26/2013,"12/26/2013"
"Drugs",67022,"Ongoing","West-Ward Pharmaceutical Corp.","Eatontown","NJ","US","Voluntary: Firm Initiated","Letter","Nationwide","D-367-2014","Class II","Carisoprodol Tablets, USP 350 mg, Rx Only, 1000 tablets. Dist by: West-ward Pharmaceutical Corp. Eatontown, NJ 07724. Mfd by: Shasun Chemicals and Drugs Limited, Unit II, R. S. Na 32, 33, 743 PIMS Rd, Periyakalepet, Pondicherry. 605014 INDIA. NDC 0143-9749-10.","NDC 0143-9749-10 Lot: 1) 10BR001B, Exp Aug-2014 2) 10BR002B, Exp Aug-2014 3) 10BR003B Exp, Aug-2014 4) 10BR004B Exp, Aug-2014 5) 10BR005B Exp, Aug-2014 6) 10BR006B Exp, Aug-2014 7) 11BR001B Exp, Aug-2014 8) 11BR002B Exp, Jul-2015 9) 11BR003B Exp, Jul-2015 10) 11BR004B Exp, Jul-2015 11) 11BR005B Exp, Jul-2015 12) 11BR006B Exp, Jul-2015",".","20,534 bottles","Presence of Foreign Substance; heavy metals (chromium, titanium etc) and inactive components of the product were visually observed during routine stability testing",11/7/2013,"11/07/2013",12/26/2013,"12/26/2013"
"Food",67023,"Ongoing","Senor Murphy Candymaker, LLC","Santa Fe","NM","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Nationwide. No military/govt/VA or foreign consignees.","F-1123-2014","Class II","Senor Murphy Santa Fe Candymaker Pecan Bueno, 4oz and 1 lb. Handmade with pecans, sugar, corn syrup, butter, soda, and salt.","ALL codes ",".","116","Senor Murphy Candymaker is recalling Pecan Bueno, Cashew Crunch, Chile Pistachio Bark, Chocolate Pretzels, Chile Peanuts, Pinon Brittle, Peanut Brittle, and Chile Peanut Brittle due to undeclared allergens. ",11/22/2013,"11/22/2013",12/26/2013,"12/26/2013"
"Food",67023,"Ongoing","Senor Murphy Candymaker, LLC","Santa Fe","NM","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Nationwide. No military/govt/VA or foreign consignees.","F-1125-2014","Class II","Senor Murphy Santa Fe Candymaker Chile Pistachio Bark , 2.5 oz and 1 lb. Handmade with dark chocolate (sugar, chocolate liquor processed with alkali, cocoa butter, milk fat, soy lecithin - an emulsifier, natural flavors), pistachios, chile, salt.","ALL codes ",".","670","Senor Murphy Candymaker is recalling Pecan Bueno, Cashew Crunch, Chile Pistachio Bark, Chocolate Pretzels, Chile Peanuts, Pinon Brittle, Peanut Brittle, and Chile Peanut Brittle due to undeclared allergens. ",11/22/2013,"11/22/2013",12/26/2013,"12/26/2013"
"Food",67023,"Ongoing","Senor Murphy Candymaker, LLC","Santa Fe","NM","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Nationwide. No military/govt/VA or foreign consignees.","F-1129-2014","Class II","Senor Murphy Santa Fe Candymaker Peanut Brittle , 4 oz and 1 lb. ","ALL codes ",".","339","Senor Murphy Candymaker is recalling Pecan Bueno, Cashew Crunch, Chile Pistachio Bark, Chocolate Pretzels, Chile Peanuts, Pinon Brittle, Peanut Brittle, and Chile Peanut Brittle due to undeclared allergens. ",11/22/2013,"11/22/2013",12/26/2013,"12/26/2013"
"Food",67023,"Ongoing","Senor Murphy Candymaker, LLC","Santa Fe","NM","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Nationwide. No military/govt/VA or foreign consignees.","F-1126-2014","Class II","Senor Murphy Santa Fe Candymaker Chocolate Pretzels 3 oz. ","ALL codes ",".","65","Senor Murphy Candymaker is recalling Pecan Bueno, Cashew Crunch, Chile Pistachio Bark, Chocolate Pretzels, Chile Peanuts, Pinon Brittle, Peanut Brittle, and Chile Peanut Brittle due to undeclared allergens. ",11/22/2013,"11/22/2013",12/26/2013,"12/26/2013"
"Food",67023,"Ongoing","Senor Murphy Candymaker, LLC","Santa Fe","NM","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Nationwide. No military/govt/VA or foreign consignees.","F-1128-2014","Class II","Senor Murphy Santa Fe Candymaker Pinon Brittle , 4 oz and 1 lb. Handmade with pinones (pine nuts), sugar, corn syrup, butter, soda, and salt.","ALL codes ",".","317","Senor Murphy Candymaker is recalling Pecan Bueno, Cashew Crunch, Chile Pistachio Bark, Chocolate Pretzels, Chile Peanuts, Pinon Brittle, Peanut Brittle, and Chile Peanut Brittle due to undeclared allergens. ",11/22/2013,"11/22/2013",12/26/2013,"12/26/2013"
"Food",67023,"Ongoing","Senor Murphy Candymaker, LLC","Santa Fe","NM","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Nationwide. No military/govt/VA or foreign consignees.","F-1130-2014","Class II","Senor Murphy Santa Fe Candymaker Chili Peanut Brittle , 4 oz and 1 lb. Handmade with sugar, corn syrup, peanuts, butter, soda, chile, and salt.","ALL codes ",".","200","Senor Murphy Candymaker is recalling Pecan Bueno, Cashew Crunch, Chile Pistachio Bark, Chocolate Pretzels, Chile Peanuts, Pinon Brittle, Peanut Brittle, and Chile Peanut Brittle due to undeclared allergens. ",11/22/2013,"11/22/2013",12/26/2013,"12/26/2013"
"Food",67023,"Ongoing","Senor Murphy Candymaker, LLC","Santa Fe","NM","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Nationwide. No military/govt/VA or foreign consignees.","F-1127-2014","Class II","Senor Murphy Santa Fe Candymaker Chile Peanuts, 4 and 9 oz. Handmade with peanuts, sugar, corn syrup, brown sugar, butter, baking soda, Shimayo red chile, and salt.","ALL codes ",".","23","Senor Murphy Candymaker is recalling Pecan Bueno, Cashew Crunch, Chile Pistachio Bark, Chocolate Pretzels, Chile Peanuts, Pinon Brittle, Peanut Brittle, and Chile Peanut Brittle due to undeclared allergens. ",11/22/2013,"11/22/2013",12/26/2013,"12/26/2013"
"Food",67023,"Ongoing","Senor Murphy Candymaker, LLC","Santa Fe","NM","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Nationwide. No military/govt/VA or foreign consignees.","F-1124-2014","Class II","Senor Murphy Santa Fe Candymaker Cashew Crunch , 4oz and 1 lb. Handmade with cashews, sugar, corn syrup, butter, soda, and salt.","ALL codes ",".","102","Senor Murphy Candymaker is recalling Pecan Bueno, Cashew Crunch, Chile Pistachio Bark, Chocolate Pretzels, Chile Peanuts, Pinon Brittle, Peanut Brittle, and Chile Peanut Brittle due to undeclared allergens. ",11/22/2013,"11/22/2013",12/26/2013,"12/26/2013"
"Drugs",67054,"Ongoing","Fresenius Kabi USA, LLC","Lake Zurich","IL","US","Voluntary: Firm Initiated","Letter","Nationwide, Puerto Rico, Canada, New Zealand","D-379-2014","Class III","FOLIC ACID INJECTION, USP; 5 mg/mL ; For IM, IV or SC Use; 10 mL; Multiple Dose Vial; Rx only; APP Pharmaceuticals, LLC; Schaumburg, IL 60173 NDC 63323-184-11","Lot 6104649, Exp. 02/14; 61047869, Exp. 03/14; 6105069, Exp. 04/14",".","215,340 vials","Failed Impurities/Degradation specifications: out-of-specification results at the 14 & 15 month time point",12/6/2013,"12/06/2013",12/26/2013,"12/26/2013"